Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This Patent Cooperation Treaty (PCT) patent application claims priority
to U.S.
Application No. 13/475,695 filed May 18, 2012, which is entitled Systems for
and
Methods of Fusing a Sacroiliac Joint, and also claims priority to U.S. Patent
Application No. 13/236,411, which is entitled "Systems for and Methods of
Fusing a
Sacroiliac Joint" filed September 19, 2011.
[0002] The present application is also related to U.S. Patent Application
12/998,712
("the '712 application"), which was filed May 23, 2011. The '712 application
is the
National Stage of International Patent Cooperation Treaty Patent Application
PCT/US2011/000070 (the 'PCT application"), which was filed January 13, 2011.
The
PCT application claims the benefit of US Provisional Patent Application
61/335,947,
which was filed January 13, 2010.
[0003]
FIELD OF THE INVENTION
[0004] Aspects of the present invention relate to medical apparatus and
methods.
More specifically, the present invention relates to devices and methods for
fusing a
sacroiliac joint.
BACKGROUND OF THE INVENTION
[0005] The sacroiliac joint is the joint between the sacrum and the ilium of
the pelvis,
which are joined by ligaments. In humans, the sacrum supports the spine and is
supported in turn by an ilium on each side. The sacroiliac joint is a synovial
joint with
articular cartilage and irregular elevations and depressions that produce
interlocking
of the two bones.
[0006] Pain associated with the sacroiliac joint can be caused by traumatic
fracture
dislocation of the pelvis, degenerative arthritis, sacroiliitis an
inflammation or
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degenerative condition of the sacroiliac joint, osteitis condensans ilii, or
other
degenerative conditions of the sacroiliac joint. Currently, sacroiliac joint
fusion is most
commonly advocated as a surgical treatment for these conditions. Fusion of the
sacroiliac
joint can be accomplished by several different conventional methods
encompassing an
anterior approach, a posterior approach, and a lateral approach with or
without
percutaneous screw or other type implant fixation. However, while each of
these methods
has been utilized for fixation and fusion of the sacroiliac joint over the
past several
decades, substantial problems with respect to the fixation and fusion of the
sacroiliac joint
remain unresolved.
[0007] A significant problem with certain conventional methods for fixation
and fusion of
the sacroiliac joint including the anterior approach, posterior approach, or
lateral
approach may be that the surgeon has to make a substantial incision in the
skin and
tissues for direct access to the sacroiliac joint involved. These invasive
approaches allow
the sacroiliac joint to be seen and touched directly by the surgeon. Often
referred to as an
"open surgery", these procedures have the attendant disadvantages of requiring
general
anesthesia and can involve increased operative time, hospitalization, pain,
and recovery
time due to the extensive soft tissue damage resulting from the open surgery.
[0008] A danger to open surgery using the anterior approach can be damage to
the L5
nerve root, which lies approximately two centimeters medial to the sacroiliac
joint or
damage to the major blood vessels. Additionally, these procedures typically
involve
fixation of the sacroiliac joint (immobilization of the articular surfaces of
the sacroiliac joint
in relation to one another) by placement of one or more screws or one or more
trans-sacroiliac implants (as shown by the non-limiting example of FIG. 1) or
by
placement of implants into the Si pedicle and iliac bone.
[0009] Use of trans-sacroiliac and Si pedicle-iliac bone implants can also
involve the risk
of damage to the lumbosacral neurovascular elements. Damage to the lumbosacral
neurovascular elements as well as delayed union or non-union of the sacroiliac
joint by
use of these procedures may require revision surgery to remove all or a
portion of the
implants or repeat surgery as to these complications.
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[0010] Another significant problem with conventional procedures utilizing
minimally
invasive small opening procedures can be that the procedures are technically
difficult,
requiring biplanar fluoroscopy of the articular surfaces of the sacroiliac
joint and extensive
surgical training and experience. Despite the level of surgical training and
experience,
there is a substantial incidence of damage to the lumbosacral neurovascular
elements.
Additionally, sacral anomalies can further lead to mal-placement of implants
leading to
damage of surrounding structures. Additionally, these procedures are often
performed
without fusion of the sacroiliac joint, which does not remove the degenerative
joint surface
and thereby does not address the degenerative condition of the sacroiliac
joint, which
may lead to continued or recurrent sacroiliac joint pain.
[0011] Another significant problem with conventional procedures can be the
utilization of
multiple trans-sacroiliac elongate implants, which do not include a threaded
surface. This
approach requires the creation of trans-sacroiliac bores in the pelvis and
nearby sacral
foramen, which can be of relatively large dimension and which are subsequently
broached with instruments, which can result in bone being impacted into the
pelvis and
neuroforamen.
[0012] The creation of the trans-sacroiliac bores and subsequent broaching of
the bores
requires a guide pin, which may be inadvertently advanced into the pelvis or
sacral
foramen, resulting in damage to other structures. Additionally, producing the
trans-sacroiliac bores, broaching, or placement of the elongate implants may
result in
damage to the lumbosacral neurovascular elements, as above discussed.
Additionally,
there may be no actual fusion of the articular portion of the sacroiliac
joint, which may
result in continued or recurrent pain requiring additional surgery.
[0013] Another substantial problem with conventional procedures can be that
placement
of posterior extra-articular distracting fusion implants and bone grafts may
be inadequate
with respect to removal of the articular surface or preparation of cortical
bone, the implant
structure and fixation of the sacroiliac joint. The conventional procedures
may not remove
sufficient amounts of the articular surfaces or cortical surfaces of the
sacroiliac joint to
relieve pain in the sacroiliac joint. The conventional implant structures may
have
insufficient or avoid engagement with the articular surfaces or cortical bone
of the
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sacroiliac joint for adequate fixation or fusion. The failure to sufficiently
stabilize and fuse
the sacroiliac joint with the conventional implant structures and methods may
result in a
failure to relieve the condition of sacroiliac joint being treated.
Additionally, conventional
methods of driving apart a sacrum and ilium may lead to mal-alignment of the
sacroiliac
joint and increased pain.
[0014] The inventive sacroiliac fusion system described herein addresses the
problems
associated with conventional methods and apparatuses used in fixation and
fusion of the
sacroiliac joint.
BRIEF SUMMARY OF THE INVENTION
[0015] One implementation of the present disclosure may take the form of a
sacroiliac
joint fusion system including a joint implant, an anchor element and a
delivery tool. The
joint implant includes a distal end, a proximal end, a body extending between
the proximal
and distal ends, and a first bore extending non-parallel to a longitudinal
axis of the body.
The anchor element includes a distal end and a proximal end and is configured
to be
received in the first bore. The delivery tool includes an implant arm and an
anchor arm.
The implant arm includes a proximal end and a distal end. The distal end of
the implant
arm is configured to releasably couple to the proximal end of the joint
implant such that a
longitudinal axis of the implant arm is substantially at least one of coaxial
or parallel with
the longitudinal axis of the body of the joint implant. The anchor arm
includes a proximal
end and a distal end. The distal end of the anchor arm is configured to engage
the
proximal end of the anchor element. The anchor arm is operably coupled to the
implant
arm in an arrangement such that the longitudinal axis of the anchor element is
generally
coaxially aligned with a longitudinal axis of the first bore when the distal
end of the implant
arm is releasably coupled with the proximal end of the joint implant and the
distal end of
the anchor arm is engaged with the proximal end of the anchor element. The
arrangement is fixed and nonadjustable.
[0016] Another implementation of the present disclosure may take the form of a
sacroiliac
joint fusion system including a joint implant, an anchor element and a
delivery tool. The
joint implant includes a distal end, a proximal end, a body extending between
the proximal
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and distal ends, and a first bore extending non-parallel to a longitudinal
axis of the body.
The anchor element includes a distal end and a proximal end and is configured
to be
received in the first bore. The delivery tool includes an implant arm and an
anchor arm.
The implant arm includes a proximal end and a distal end. The distal end of
the implant
arm is configured to releasably couple to the proximal end of the joint
implant such that a
longitudinal axis of the implant arm is substantially at least one of coaxial
or parallel with
the longitudinal axis of the body of the joint implant. The anchor arm
includes a proximal
end and a distal end. The distal end of the anchor arm includes a guide. The
anchor arm
is pivotally coupled to the implant arm and configured such that a center of
the guide
moves along an arc that extends through generally the center of the first bore
of the
implant when the distal end of the implant arm is releasably coupled with the
proximal end
of the joint implant. The anchor arm is configured to deliver the anchor
element to the first
bore.
[0017] Yet another implementation of the present disclosure may take the form
of a
sacroiliac joint fusion system including a joint implant and a tool. In one
embodiment, the
joint implant includes a longitudinal axis and a first bore extending non-
parallel to the
longitudinal axis. The anchor element is configured to be received in the
first bore. The
delivery tool includes an implant arm and an anchor arm. The implant arm is
configured
to releasably couple to the joint implant. The anchor arm is coupled to the
implant arm
and configured to deliver the anchor element to the first bore. The final
manufactured
configuration of the tool and final manufactured configuration of the joint
implant are such
that, when the system is assembled such that the implant arm is releasably
coupled to the
joint implant, a delivery arrangement automatically exists such that the
anchor arm is
correctly oriented to deliver the anchor element to the first bore.
[0018] Another implementation of the present disclosure may take the form of a
method of
sacroiliac joint fusion. In one embodiment, the method includes: a)
approaching a
sacroiliac joint space with a joint implant comprising at least first and
second planar
members radially extending generally coplanar with each other from opposite
sides of a
body of the joint implant; b) delivering the joint implant into a sacroiliac
joint space, the
joint implant being oriented in the sacroiliac joint space such that the first
and second
planar members are generally coplanar with a joint plane of the sacroiliac
joint space;
and c) causing an anchor element to be driven generally transverse to the
joint plane
through bone material defining at least a portion of the sacroiliac joint
space and into
a bore of the joint implant that extends generally transverse to the body of
the joint
implant.
[0019] Yet another implementation of the present disclosure may take the form
of a
medical kit for the fusion of a sacroiliac joint including a caudal access
region and a
joint plane. In one embodiment, the kit includes: a) a delivery tool
comprising an
implant arm and an anchor arm coupled to the implant arm; b) a joint implant
comprising a bore defined therein that extends generally transverse to a
longitudinal
length of the joint implant; and c) an anchor element configured to be
received in the
bore of the joint implant. The bore of the implant, the implant, the implant
arm and
the anchor arm have an as-manufactured configuration that allows the anchor
arm to
properly align the anchor element to be received in the bore of the implant
when the
implant is coupled to the implant arm.
[0019A] Yet another implementation of the present disclosure may take the form
of a
sacroiliac joint fusion system comprising: a) a joint implant comprising a
distal end
and a proximal end opposite the distal end; b) an anchor element comprising a
distal
end and a proximal end; and c) a delivery tool comprising: i) an implant arm
comprising a proximal end and a distal end, the distal end of the implant arm
configured to releasably couple to the proximal end of the joint implant; and
ii) an
anchor arm comprising a proximal end, a distal end, a header and a member, the
proximal end of the anchor arm coupled to the implant arm and the header
supported
on the anchor arm near the distal end of the anchor arm, the header including
first
and second guide holes, the first guide hole configured to orient the member
when
received in the first guide hole in a first approach aimed at least in the
vicinity of the
joint implant when the proximal end of the joint implant is releasably coupled
to the
distal end of the implant arm, the second guide hole configured to orient the
member
when received in the second guide hole in a second approach aimed at least in
the
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vicinity of the joint implant when the proximal end of the joint implant is
releasably
coupled to the distal end of the implant arm, the first and second approaches
being
different, the member configured to guide the delivery of the anchor element
to at
least in the vicinity of the joint implant when the proximal end of the joint
implant is
releasably coupled to the distal end of the implant arm.
[0020] While multiple embodiments are disclosed, still other embodiments of
the
present disclosure will become apparent to those skilled in the art from the
following
detailed description, which shows and describes illustrative embodiments of
the
disclosure. As will be realized, the invention is capable of modifications in
various
aspects, all without departing from the spirit and scope of the present
disclosure.
Accordingly, the drawings and detailed description are to be regarded as
illustrative in
nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is an anterior view of the pelvic region and a conventional
method and
device for stabilizing the sacroiliac joint.
[0022] FIG. 2A is an isometric view of a first embodiment of a system for
fusing a
sacroiliac joint.
[0023] FIG. 2B is the same view as FIG. 2A, except the delivery tool and
implant
assembly are decoupled from each other.
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[0024] FIG. 3 is the same view as FIG. 2A, except the system is exploded to
better
illustrate its components.
[0025] FIG. 4 is a top-side isometric view of the implant assembly.
[0026] FIG. 5 is a distal end isometric view of the implant of the implant
assembly of FIG.
4.
[0027] FIG. 6 is a proximal end isometric view of the implant.
[0028] FIG. 7 is a bottom-side isometric view of the implant assembly.
[0029] FIG. 8 is another proximal end isometric view of the implant.
[0030] FIG. 9 is another distal end isometric view of the implant.
[0031] FIGS. 10 and 11 are opposite side elevation views of the implant.
[0032] FIGS. 12 and 13 are opposite plan views of the implant.
[0033] FIG. 14 is a distal end elevation of the implant.
[0034] FIG. 15 is a proximal end elevation of the implant.
[0035] FIG. 16 is an isometric longitudinal cross section of the implant as
taken along
section line 16-16 of FIG. 11.
[0036] FIG. 17 is an isometric longitudinal cross section of the implant as
taken along
section line 17-17 of FIG. 13.
[0037] FIG. 18 is a proximal isometric view of the arm assembly.
[0038] FIG. 19 is a distal isometric view of the arm assembly 85.
[0039] FIG. 20 is a longitudinal cross section of the implant arm as taken
along section
line 20-20 in FIG. 18.
[0040] FIG. 21A is a side elevation of the system wherein the tool is attached
to the
implant assembly for delivery of the implant assembly to the sacroiliac joint.
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[0041] FIG. 21B is the same view as FIG. 21A, except illustrating a series of
interchangeable anchor arms that may be coupled to the implant arm to adjust
the tool for
the patient, but maintain the angular relationship between the components of
system that
allows the anchor member to be delivered into the implant bore without
adjustment to the
delivery tool.
[0042] FIG. 21C is the same view of FIG. 21A, except illustrating a version of
the same
embodiment wherein the anchor arm is more proximally located along the implant
arm.
[0043] FIG. 22 is the same view as FIG. 21A, except shown as a longitudinal
cross
section.
[0044] FIG. 23 is an enlarged view of the distal region of the system circled
in FIG. 22.
[0045] FIG. 24 is an enlarged cross sectional plan view taken in a plane 90
degrees from
the section plane of FIG. 23.
[0046] FIG. 25 is a proximal isometric view of the handle.
[0047] FIG. 26 is a distal isometric view of the handle.
[0048] FIG. 27 is a cross sectional distal isometric view of the handle.
[0049] FIG. 28 is an isometric view of the implant retainer.
[0050] FIG. 29 is a longitudinal cross sectional isometric view of the implant
retainer.
[0051] FIG. 30A is an isometric view of the sleeve.
[0052] FIG. 30B is a longitudinal cross section of an embodiment of the sleeve
having
multiple sleeve portions.
[0053] FIG. 31 is an isometric view of a trocar, guidewire, drill,
screwdriver, etc. for
insertion through the lumen of the sleeve.
[0054] FIG. 32 is an isometric view of a second embodiment of a system for
fusing a
sacroiliac joint.
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[0055] FIG. 33 is the same view as FIG. 32, except the system is exploded to
better
illustrate its components.
[0056] FIG. 34 is a side elevation of the system embodiment of FIG. 32.
[0057] As shown in FIG. 35 is a proximal isometric view of the implant arm of
the
embodiment of FIG. 32.
[0058] FIG. 36 is an isometric view of the anchor arm.
[0059] FIGS. 37 and 38 are different isometric views of a third embodiment of
the system.
[0060] FIG. 39 is the same view as FIG. 37, except the system is shown
exploded to
better illustrate the components of the system.
[0061] FIG. 40 is a side elevation of the system of FIG. 37, wherein the tool
is attached to
the implant assembly for delivery of the implant assembly to the sacroiliac
joint.
[0062] FIGS. 41-44 are various isometric views of the implant of the third
embodiment of
the system.
[0063] FIGS. 45-46 are opposite plan views of the implant.
[0064] FIGS. 47-50 are various elevation views of the implant.
[0065] FIGS. 51-52 are, respectively, isometric and side elevation views of an
implant
having an anchor member receiving arm.
[0066] FIG. 53 is an enlarged view of the disk-shaped seat of the implant arm
of FIG. 51.
[0067] FIG. 54 is an isometric view of an implant with another type of anchor
member
locking mechanism.
[0068] FIG. 55 is an enlarged view of the free end of the anchor member
locking
mechanism of FIG. 54.
[0069] FIGS. 56-61 are, respectively, front isometric, rear isometric, side
elevation, plan,
front elevation, and rear elevation views of another embodiment of the
implant.
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[0070] FIGS. 62-67 are, respectively, front isometric, rear isometric, side
elevation, plan,
front elevation, and rear elevation views of yet another embodiment of the
implant.
[0071] FIGS. 68-73 are, respectively, front isometric, rear isometric, side
elevation, plan,
front elevation, and rear elevation views of still another embodiment of the
implant.
[0072] FIGS. 74-79 are, respectively, front isometric, rear isometric, side
elevation, plan,
front elevation, and rear elevation views of yet another embodiment of the
implant.
[0073] FIGS. 80-85 are, respectively, front isometric, rear isometric, side
elevation, plan,
front elevation, and rear elevation views of still yet another embodiment of
the implant.
[0074] FIG. 86 is an isometric view of the delivery tool.
[0075] FIGS. 87-88 are generally opposite isometric views of the delivery tool
in an
exploded state.
[0076] FIG. 89 is an isometric view of the handle.
[0077] FIG. 90 is an exploded isometric view of the retaining collar and
handle shown in
longitudinal cross section.
[0078] FIG. 91 is a longitudinal cross section of the delivery tool 20 when
assembled as
shown in FIG. 86.
[0079] FIG. 92 is a side view of an implant retainer similar to that described
with respect to
FIGS. 86-91, except having a modified distal end.
[0080] FIGS. 93-94 are, respectively, longitudinal and transverse cross
sectional views of
an implant with an engagement hole configured to complementarily engage with
the
T-shaped distal end of the retainer of FIG. 92.
[0081] FIG. 95 is the same view as FIG. 93, except with the retainer received
in the hole.
[0082] FIG. 96A is a right lateral side view of a hip region of a patient
lying prone, wherein
the soft tissue surrounding the skeletal structure of the patient is shown in
dashed lines.
[0083] FIG. 96B is an enlarged view of the hip region of FIG. 96A.
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[0084] FIG. 97A is a lateral-posterior view of the hip region of the patient
of FIG. 96A,
wherein the patient is lying prone and the soft tissue surrounding the
skeletal structure of
the patient is shown in dashed lines.
[0085] FIG. 97B is an enlarged view of the hip region of FIG. 97A.
[0086] FIG. 98A is a posterior view of the hip region of the patient of FIG.
96A, wherein the
patient is lying prone and the soft tissue surrounding the skeletal structure
of the patient is
shown in dashed lines.
[0087] FIG. 98B is an enlarged view of the hip region of FIG. 98A.
[0088] FIGS. 99A-99Q are each a step in the methodology and illustrated as the
same
transverse cross section taken along a plane extending medial-lateral and
anterior
posterior along section line 99-99 in FIG. 98B.
[0089] FIG. 100A is a posterior-lateral view of the hip region of the patient,
illustrating the
placement of a cannula alignment jig.
[0090] FIGS. 100B-1000 are different isometric views of the cannula alignment
jig.
[0091] FIG. 101A is a posterior-lateral view of the hip region of the patient,
illustrating the
placement of a drill jig.
[0092] FIG. 101B is an isometric view of the drill jig.
[0093] FIG. 102A is a lateral view of the hip region of the patient,
illustrating the implant
implanted in the caudal region of the sacroiliac join space.
[0094] FIG. 102B is an anterior view of the hip region of the patient,
illustrating the implant
implanted in the caudal region of the sacroiliac join space.
[0095] FIG. 1020 is an enlarged view of the implant taken along the plane of
the sacroiliac
joint.
[0096] FIG. 102D is a transverse cross section of the implant and joint plane
taken along
section line 102D-102D of FIG. 1020.
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[0097] FIG. 103A is generally the same view as FIG. 97A, except illustrating
the delivery
tool being used to deliver the implant to the sacroiliac joint space.
[0098] FIG. 103B is an enlarged view of the hip region of FIG. 103A.
[0099] FIG. 104 is generally the same enlarged view as FIG. 96B, except
illustrating the
delivery tool being used to deliver the implant to the sacroiliac joint space.
[00100] FIG. 105 is the same view as FIG. 104, except the implant has now
been
fully inserted into the prepared space in the sacroiliac joint.
[00101] FIG. 106A is the same view as FIG. 104, except the sleeve is now
received
in the collar of the anchor arm.
[00102] FIG. 106B is generally the same view as FIG. 106A, except the ilium
is
removed to show the sacroiliac joint space boundary defined along the sacrum
and the
implant positioned for implantation within the joint space.
[00103] FIG. 107A is a posterior-inferior view of the hip region of the
patient,
wherein the soft tissue surrounding the skeletal hip bones is shown in dashed
lines.
[00104] FIG. 107B is an enlarged view of the implant region of FIG. 107A.
[00105] FIGS. 108A and 108B are, respectively, posterior and posterior-
lateral
views of the implantation area and the implant assembly implanted there.
[00106] FIG. 109 is an isometric view of the system wherein the tool is
attached to
the implant for delivery of the implant to the sacroiliac joint.
[00107] FIG. 110 is a view of the system wherein the implant and anchor arm
are
shown in plan view.
[00108] FIG. 111A is an inferior-posterior view of the patient's hip
skeletal structure
similar to the view depicted in FIG. 107A.
[00109] FIG. 111B is a lateral-superior-posterior view of the patient's hip
skeletal
structure.
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[00110] FIG. 1110 is an inferior-posterior view of the patient's hip
skeletal structure
taken from a perspective laterally opposite the view depicted in FIG. 111B.
[00111] FIG. 112A is an inferior-posterior view of the patient's hip
skeletal structure
similar to the view depicted in FIG. 107A.
[00112] FIG. 112B is a side view of the patient's hip skeletal structure
similar to the
view depicted in FIG. 106A.
[00113] FIG. 112C is a view of the patient's hip skeletal structure similar
to the view
depicted in FIG. 103A, except from an opposite lateral perspective.
[00114] FIG. 112D is a superior view of the patient's hip skeletal
structure.
[00116] FIG. 113 is a plan view of a medical kit containing the components
of the
system, namely, the delivery tool, multiple implants of different sizes, and
multiple anchor
members of different sizes, wherein the system components are sealed within
one or
more sterile packages and provided with instructions for using the system.
[00116] FIG. 114 is the same transverse cross sectional view of the
patient's hip as
shown in FIGS. 99A-99Q, except showing the implant having structure attached
thereto
that will allow the implant to serve as an attachment point for structural
components of a
spinal support system configured to support across the patient's hip structure
and/or to
support along the patient's spinal column.
[00117] FIG. 115 is a posterior view of the patient's sacrum and illiums,
wherein
structural components of a spinal support system extend medial-lateral across
the
patient's hip structure and superiorly to support along the patient's spinal
column.
[00118] FIG. 116 is the same view as FIG. 117, except having a different
spanning
member structure.
[00119] FIG. 117A is a lateral-inferior-posterior view of the patient's hip
skeletal
structure similar to the view depicted in FIG. 111C.
[00120] FIG. 117B is an inferior-posterior view of the patient's hip
skeletal structure
similar to the view depicted in FIG. 111A.
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[00121] FIG. 1170 is the same view as FIG. 106B, except showing the implant
being implanted in the extra-articular space, as opposed to the sacroiliac
joint articular
region.
[00122] FIGS. 118A-1180 are, respectively, isometric and opposite plan
views of an
implant with a side-to-side deviated bore.
[00123] FIGS. 119A-119E are, respectively, distal end isometric, side
elevation,
plan, distal end elevation, and proximal end elevation views of another
embodiment of the
implant.
[00124] FIGS. 120A-120B are, respectively, distal end isometric and side
elevation
views of yet another embodiment of the implant.
[00125] FIGS. 121A-121G are, respectively, distal end isometric, side
elevation,
plan, distal end elevation, proximal end elevation, proximal end isometric,
and side
elevation views of still another embodiment of the implant.
[00126] FIG. 121 H is a schematic depiction of a system for fusing a joint,
wherein
the joint implant includes an electrode in electrical communication with a
nerve sensing
system.
[00127] FIG. 122 is a proximal end isometric view of another embodiment of
the
implant assembly.
[00128] FIGS. 123A-123E are, respectively, distal end isometric, side
elevation,
plan, distal end elevation, and proximal end elevation views of yet another
embodiment of
the implant.
[00129] FIGS. 124A and 124B1 are isometric views of another embodiment of
the
delivery tool coupled and decoupled with the implant, respectively.
[00130] FIG. 124B2 is a cross section view as taken along section line
124B2-124B2 in FIG. 124B1.
[00131] FIG. 1240 is an isometric view of the delivery tool in an exploded
state.
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[00132] FIG. 124D is an enlarged view of the distal end of the implant arm
of the
delivery tool.
[00133] FIGS. 124E-124H are, respectively, distal end isometric, side
elevation,
plan, and opposite plan views of a version of the embodiment of the implant of
FIGS.
123A-123E, wherein the version includes a bore for receiving an anchor.
[00134] FIG. 125A is an isometric view of another embodiment of the
implant.
[00135] FIG. 125B is a longitudinal cross section view of the implant of
FIG. 125A.
[00136] FIG. 126A is an isometric view of another embodiment of the implant
assembly.
[00137] FIG. 126B is a longitudinal cross section view of the implant of
FIG. 126A.
[00138] FIG. 127 is an isometric view of an embodiment of a sleeve mounted
on an
implant arm of a delivery system similar to the delivery system of FIG. 88,
wherein the
sleeve facilitates visualization of the trans screw and trajectory.
[00139] FIG. 128A is an isometric view of another embodiment of the sleeve
of FIG.
127.
[00140] FIG. 128B is an end view of sleeve of FIG. 127.
[00141] FIG. 128C is a posterior view of the hip region, wherein the sleeve
of FIG.
127 is being employed.
[00142] FIGS. 129A-129B show isometric views of another embodiment of the
system, wherein the delivery tool has a series of interchangeable anchor arms
that may
be coupled to the implant arm to adjust the tool for the patient, but maintain
the angular
relationship between the components of system that allows the anchor member to
be
delivered into the implant bore and/or another location adjacent to the
implant without
adjustment to the delivery tool.
[00143] FIG. 1290 shows an enlarged view of the arm assembly of the
delivery tool
of FIGS. 129A-129B.
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[00144] FIGS. 1290-129K are, respectively, distal end isometric, proximal
end
isometric, side elevation, opposite side elevation, plan, opposite plan,
proximal end
elevation, and distal end elevation views of an embodiment of the implant
intended for
use with the system of FIGS. 129A-1290.
[00145] FIG. 129L is an enlarged isometric view of the implant of FIGS.
1290-129K
mounted on the extreme distal end of the implant arm of the delivery tool of
FIGS.
129A-129C.
[00146] FIGS. 129M and 129N are side views of the distal regions of two
alternative
implant arms arrangements.
[00147] FIG. 1290 (not used)
[00148] FIG. 129P is an exploded isometric view of the implant arm of FIG.
129M.
[00149] FIGS. 130A-130B show anterior views of the hip region with the
system of
FIGS. 129A-129C, wherein the ilium is shown and hidden, respectively.
[00150] FIGS. 130C-130G show anterior-superior-lateral, posterior,
superior, lateral,
and inferior views of the hip region with the system of FIGS. 129A-1290.
[00151] FIGS. 130H and 1301 show inferior and posterior-lateral views of a
patient,
wherein the system of FIGS. 129A-1290 is inserted through the soft tissue of
the hip
region.
[00152] FIGS. 131A-131B show isometric views of another embodiment of the
system.
[00153] FIG. 1310 shows an enlarged plan view of the arm assembly of the
delivery
tool of FIGS. 131A-131B.
[00154] FIGS. 1310-131E are isometric view of a version of the implant of
FIGS.
129D-121K adapted for use with the delivery system of FIGS. 131A-1310.
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[00155] FIG. 131F is an isometric view of a version of the implant of FIGS.
129D-129K, wherein the body of the implant is hollow and configured to work
with a distal
end of an implant arm configured to remove cartilage.
[00156] FIG. 131G is an isometric view of the distal end of the implant arm
configured to be received in the hollow body of the implant of FIG. 131F,
wherein the
distal end of the implant arm is configured to remove cartilage.
[00157] FIG. 131H is an isometric view of the implant arm distal end of
FIG. 131G
received in the implant of FIG. 131F.
[00158] FIG. 1311 is an isometric longitudinal cross section of the implant
arm distal
end and implant supported thereon as taken along section line 1311-1311 of
FIG. 131H.
[00159] FIG. 132A is an isometric view of yet another embodiment of the
system for
fusing a sacroiliac joint.
[00160] FIG. 132B is the same view as FIG. 132A, except the system is
exploded to
better illustrate its components.
[00161] FIG. 133A is an isometric view of yet another embodiment of the
system for
fusing a sacroiliac joint.
[00162] FIG. 133B shows another isometric view of the system of FIG. 133A.
[00163] FIG. 133C shows the same view as FIG. 133B, except the system is
inserted through the soft tissue of the hip region of the patient.
[00164] FIG. 1330 is the same view as FIG. 133C, except the soft tissue is
hidden to
show the patient bone structure.
[00165] FIG. 133E shows a rear elevation view of the system of FIG. 133A.
[00166] FIG. 133F shows the same view as FIG. 133E, except the system is
inserted through the soft tissue of the hip region of the patient.
[00167] FIG. 133G is the same view as FIG. 133F, except the soft tissue is
hidden to
show the patient bone structure.
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[00168] FIG. 134A illustrates an embodiment of a system for extracting an
implant.
[00169] FIGS. 134B-1340 show enlarged views of the distal end of the system
of
FIG. 134A, wherein the distal end is decoupled and coupled to the implant,
respectively.
[00170] FIG. 134D is a longitudinal cross section as taken along section
line
134D-134D of FIG. 134C.
[00171] FIG. 134E is the same view as FIG. 134A, except the system is
exploded to
better illustrate its components.
[00172] FIG. 134F is an isometric view of the proximal end of the implant
of FIGS.
134B-134C.
[00173] FIGS. 135A-1350 are respectively a first isometric, a second
isometric and
a plan view of an implant embodiment having a shape that generally mimics or
resembles
that of a sacroiliac joint space as viewed from a substantially lateral view.
[00174] FIGS. 136A-1360 are generally opposite isometric views of an
implant
embodiment that is configured to transition from a generally linear,
rectangular
arrangement (shown in FIGS. 136A-136B) to a boot or L-shaped configuration
(shown in
FIGS. 136C-136D) that generally fills and/or mimics the shape of the
sacroiliac joint
space.
[00175] FIG. 136E is an exploded isometric view of the implant of FIGS.
136A-136D.
[00176] FIGS. 136F and 136G are, respectively, proximal and distal
elevations of
the implant of FIGS. 136A-136D.
[00177] FIGS. 136H and 1361 are, respectively, top and bottom plan views of
the
implant of FIGS. 136A-136D.
[00178] FIG. 136J is a longitudinal cross sectional elevation of the
implant of FIGS.
136A-136D as taken along section line 136J-136J.
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[00179] FIGS. 136K and 136L are respective enlarged views of the upper and
lower
cylinder regions of FIG. 136J.
[00180] FIGS. 137A and 137B are generally opposite isometric views of an
implant
embodiment configured to essentially mimic at least a portion of the
sacroiliac joint space.
[00181] FIGS. 137C-137F are, respectively, a top plan view, a distal end
elevation,
a side elevation, and a proximal elevation of the implant of FIGS. 137A and
137B.
[00182] FIGS. 138A and 138B are generally opposite isometric views of an
implant
embodiment configured to essentially mimic at least a portion of the
sacroiliac joint space.
[00183] FIGS. 1380-138F are, respectively, a top plan view, a distal end
elevation,
a side elevation, and a proximal elevation of the implant of FIGS. 138A and
138B.
[00184] FIGS. 139A and 139B are, respectively, distal isometric and
proximal
isometric views of an implant arm engaged with an adaptor and an implant.
[00185] FIGS. 1390 and 1390 are the same views as FIGS. 139 A and 139 B,
respectively, except without implant.
[00186] FIGS. 139E and 139F are the same views as FIGS. 139 A and 139 B,
respectively, except without the implant and adaptor.
[00187] FIG. 139G is the distal isometric view of the adaptor depicted in
FIGS. 139A
and 139B.
[00188] FIG. 139H is the proximal isometric view of the adaptor depicted in
FIGS.
139A and 139B.
DETAILED DESCRIPTION
[00189] Implementations of the present disclosure involve a system 10 for
fusing a
sacroiliac joint. The system 10 includes a delivery tool 20 and an implant
assembly 15 for
delivery to a sacroiliac joint via the delivery tool 20. The implant assembly
15, which
includes an implant 25 and anchor 30, is configured to fuse a sacroiliac joint
once
implanted at the joint. The tool 20 is configured such that the anchor 30 can
be quickly,
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accurately and reliably delivered to a bore 40 of an implant 25 supported off
of the tool
distal end in a sacroiliac joint.
[00190] To begin a detailed discussion of a first embodiment of the system
10,
reference is made to FIGS. 2A-3. FIG. 2A is an isometric view of the system
10. FIG. 2B
is the same view as FIG. 2A, except an implant assembly 15 of the system 10 is
separated from a delivery tool 20 of the system 10. FIG. 3 is the same view as
FIG. 2A,
except the system 10 is shown exploded to better illustrate the components of
the system
10.
[00191] As can be understood from FIGS. 2A and 2B, the system 10 includes a
delivery tool 20 and an implant assembly 15 for implanting at the sacroiliac
joint via the
delivery tool 20, the implant assembly 15 being for fusing the sacroiliac
joint. As indicated
in FIG. 3, the implant assembly 15 includes an implant 25 and an anchor
element 30 (e.g.,
a bone screw or other elongated body). As discussed below in greater detail,
during the
implantation of the implant assembly 15 at the sacroiliac joint, the implant
25 and anchor
element 30 are supported by a distal end 35 of the delivery tool 20, as
illustrated in FIG.
2A. In one embodiment, the distal end 35 may be fixed or non-removable from
the rest of
the delivery tool 20. In other embodiments, as discussed below with respect to
FIGS.
139A-139H, the distal end 35 of the delivery tool 20 may be removable so as to
allow
interchanging of different sized or shaped distal ends 35 to allow matching to
particular
implant embodiments without requiring the use of a different delivery tool 20
and while
maintaining the alignment between components (e.g., anchor 30 aligned with
bore 40)
The delivery tool 20 is used to deliver the implant 25 into the sacroiliac
joint space. The
delivery tool 20 is then used to cause the anchor element 30 to extend through
the ilium,
sacrum and implant 25 generally transverse to the sacroiliac joint and implant
25. The
delivery tool 20 is then decoupled from the implanted implant assembly 15, as
can be
understood from FIG. 2B.
[00192] To begin a detailed discussion of components of an embodiment of
the
implant assembly 15, reference is made to FIG. 4, which is a side isometric
view of the
implant assembly 15. As shown in FIG. 4, the implant assembly 15 includes an
implant
25 and an anchor element 30. The anchor element 30 may be in the form of an
elongated
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body such as, for example, a nail, rod, pin, threaded screw, expanding body, a
cable (e.g.,
configured with a ball end), etc. The anchor element 30 is configured to be
received in a
bore 40 defined through the implant 25. The bore 40 extends through the
implant 25 and
is sized such that the anchor element 30 can at least extend into or through
the implant 25
as illustrated in FIG. 4.
[00193] For a detailed discussion of the implant 25, reference is made to
FIGS. 5-17.
FIGS. 5-9 are various isometric views of the implant 25. FIGS. 12 and 13 are
opposite
plan views of the implant 25, and FIGS. 10, 11, 14 and 15 are various
elevation views of
the implant. FIGS. 16 and 17 are isometric longitudinal cross sections of the
implant 25
as taken along corresponding section lines in FIGS. 11 and 13, respectively.
[00194] As shown in FIGS. 5-15, in one embodiment, the implant 25 includes
a
distal or leading end 42, a proximal or trailing end 43, a longitudinally
extending body 45,
a bore 40 extending through the body, and keels, fins or planar members 50, 55
that
radially extend outwardly away from the body 45. In one embodiment, the
radially
extending planar members 50, 55 may be grouped into pairs of planar members
50, 55
that are generally coplanar with each other. For example, planar members 50
that are
opposite the body 45 from each other generally exist in the same plane. More
specifically,
as best understood from FIGS. 14 and 15, the planar faces 60 of a first planar
member 50
are generally coplanar with the planar faces 60 of a second planar member 50
opposite
the body 45 from the first planar member 50. Likewise, the planar faces 65 of
a third
planar member 55 are generally coplanar with the planar faces 65 of a fourth
planar
member 55 opposite the body 45 from the third planar member 55.
[00195] As best understood from FIGS. 14 and 15, one set of planar members
50
(i.e., the large planar members 50) may extend radially a greater distance D1
than the
distance D2 extended radially by the other set of planar members 55 (i.e., the
small planar
members 55). Also, the width W1 of a large planar member 50 from its outer
edge to its
intersection with the body 45 may be greater than the width W2 of a small
planar member
55 from its outer edge to its intersection with the body 45. Also, the
thickness T1 of the
large planar members 50 may be greater than the thickness T2 of the small
planar
members 55. Thus, one set of planar members 50 may be both wider and thicker
than the
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other set of planar members 55. In other words, one set of planar members 50
may be
larger than the other set of planar members 55.
[00196] In one embodiment, the distance Di spanned by the large planar
members
50 is between approximately 5 mm and approximately 30 mm, with one embodiment
having a distance D1 of approximately 20 mm, and the distance D2 spanned by
the small
planar members 55 is between approximately 5 mm and approximately 20 mm, with
one
embodiment having a distance D2 of approximately 14 mm. The width W1 of a
large
planar member 50 is between approximately 2.5 mm and approximately 15 mm, with
one
embodiment having a width W1 of approximately 5 mm, and the width W2 of a
small planar
member 55 is between approximately 1 mm and approximately 10 mm, with one
embodiment having a width W2 of approximately 3 mm. The thickness T1 of a
large
planar member 50 is between approximately 2 mm and approximately 20 mm, with
one
embodiment having a thickness T1 of approximately 4 mm, and the thickness T2
of a small
planar member 55 is between approximately 1 mm and approximately 10 mm, with
one
embodiment having a thickness T2 of approximately 2 mm.
[00197] As indicated in FIGS. 5-15, the first set of planar members 50 are
generally
perpendicular with the second set of planar members 55. Since the sets of
planar
members 50, 55 are perpendicular to each other, in one embodiment, the
intersection of
the planar members 50, 55 at a central longitudinal axis of the implant 25 may
form the
body 45 of the implant 25. In other embodiments, and as illustrated in FIGS. 5-
14, the
body 45 may be of a distinct shape so as to have, for example, a cylindrical
or other
configuration. In one embodiment, as indicated in FIG. 14, the cylindrical
body 45 has a
radius R1 of between approximately 1 mm and approximately 20 mm, with one
embodiment having a radius R1 of approximately 10 mm.
[00198] As illustrated in FIG. 12, in one embodiment, the implant 25 has a
length L1
of between approximately 5 mm and approximately 70 mm, with one embodiment
having
a length L1 of approximately 45 mm.
[00199] As indicated in FIGS. 5 and 9-14, the implant distal end 42 may
have a
bulletnose or otherwise rounded configuration, wherein the rounded
configuration
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extends outward away from the distal extremity of the body 45 and along the
distal or
leading edges of the planar members 50, 55. Thus, as can be understood from
FIGS. 5
and 9-13, the leading or distal edges 57 of the planar members 50, 55 may be
rounded in
the radially extending length of the lead or distal edges and/or in a
direction transverse to
the radially extending length of the lead or distal edges. In one embodiment,
the leading
edges 57 of the planar members 50, 55 each have a radius R2 of between
approximately
1 mm and approximately 15 mm, with one embodiment having a radius R2 of
approximately 10 mm. In one embodiment, the leading end 42 of the implant body
45 and
the leading edges 57 of the planar members 50, 55 have a generally conical
point
configuration.
[00200] As indicated in FIGS. 6-8, 10-13, and 15, the implant proximal end
43 has a
generally planar face that is generally perpendicular to a longitudinal center
axis CA of the
implant 25. A center attachment bore 70 and two lateral attachment bores 75 on
opposite
sides of the center bore 70 are defined in the implant proximal end 43. The
center bore 70
is centered about the longitudinal center axis CA, and the lateral attachment
bores 75 are
near outer ends of the long planar members 50, generally centered in the
thickness of the
larger planar members 50. Alternatively, in particular embodiments, the
implant proximal
end 43 can be configured to have a face similarly configured to the implant
distal end 42
(i.e. rounded, bullet nosed, etc.) to allow for a simplified removal of
implant 25 during a
revision surgery.
[00201] As indicated in FIGS. 16 and 17, the center bore 70 may be a blind
hole in
that it only has a single opening. Alternatively, the center bore 70 may be
configured as a
hole that communicates between the implant proximal end 43 and implant bore
40. A
center bore so configured may be able to receive a fastener to permit
interference with the
anchor member 30 extending through the bore 40 after implantation to resist
migration of
said anchor member.
[00202] As illustrated in FIG. 16, the lateral bores 75 are also blind
holes and can be
configured to not extend nearly as far into the body 45 as the center hole 70
and can be
configured to be not nearly as great in diameter as the center hole 70. In one
embodiment,
the center attachment bore 70 has a diameter of between approximately 2 mm and
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approximately 10 mm, with one embodiment having a diameter of approximately 5
mm.
In one embodiment, the lateral attachment bores 75 can each have a diameter of
between approximately 0.5 mm and approximately 3 mm, with one embodiment
having a
diameter of approximately 1.5 mm.
[00203] As can be understood from FIG. 17, the implant bore 40, which is
configured to receive the anchor member 30, has a longitudinal center axis BA
that is
generally transverse to the longitudinal center axis CA of the implant 25. In
one
embodiment, the implant bore longitudinal center axis BA forms an angle
ABA_cp, with the
implant longitudinal center axis CA. For example, the angle ABA_cA may be
between
approximately 15 degrees and approximately 135 degrees, with one embodiment
being
approximately 45 degrees.
[00204] As shown in FIGS. 4-17, the bore 40 is generally located within a
plane with
which the small radial planar members 55 are located. That the bore 40 is
located in the
same plane as occupied by the small radial planar members 55 is also the case
where the
bore 40 angularly deviates from being perpendicular with the longitudinal axis
of the
implant body 45.
[00205] In one embodiment, the implant 25 may be machined, molded, formed,
or
otherwise manufactured from stainless steel, titanium, ceramic, polymer,
composite,
bone or other biocompatible materials. The anchor member 30 may be machined,
molded, formed or otherwise manufactured from similar biocompatible materials.
[00206] In some embodiments, the implant 25 may be substantially as
described
above with respect to FIGS. 4-17, except the bore 40 of the implant 25 may be
angled
side-to-side relative to the longitudinal axis of the implant body 45 such
that the bore 40 is
not contained in the plane occupied by the small radial planar members 55. For
example,
as shown in FIGS. 118A-1180, which are, respectively, isometric and opposite
plan views
of an implant 25 with such a side-to-side deviated bore 40, the bore daylights
in the body
45 and large radial planar members 50. In doing so, the bore 40 deviates side-
to-side
from the plane in which the small planar members 55 are located. Since the
bore
daylights in the body 45 and large planar members 50, the bore 40 of FIGS.
118A-118C
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differs from that of FIGS. 4-17, wherein the bore 40 daylights in the small
radial members
55.
[00207] Just like delivery tool 20 of FIG. 2A has an as-manufactured
configuration
that allows the anchor arm 115 to deliver the anchor element 30 to the bore 40
of the
implant 25 of FIGS. 4-17 without necessitating modification of the delivery
tool 20
configuration subsequent to the tool 20 leaving its manufacturing facility, a
delivery tool 20
can be configured to similarly interact with the bore 40 of the implant 25 of
FIGS.
118A-118C.
[00208] In some embodiments, the implant 25 may be substantially as
described
above with respect to FIGS. 4-17, except the implant 25 may further include an
anchor
member receiving arm 300. For example, as shown in FIGS. 51-52, which are,
respectively, isometric and side elevation views of an implant 25 having an
anchor
member receiving arm 300, the arm 300 may be generally cantilevered off of the
proximal
end 43 of the implant 25. The arm 300 includes a free end 305 with a disk-
shaped seat
310 having a center hole 315 with a center axis that is coaxially aligned with
the center
axis BA of the bore 40.
[00209] In one embodiment, the arm 300 is rigidly fixed to the implant
proximal end
43. In other embodiments, the arm 300 may be in a pivotable or hinged
configuration with
the implant proximal end 43 to allow movement between the implant 25 and arm
300.
Such a hinged arm configuration may be further configured to have a free end
305 which
may have a hole 315 (or slot). Due to the hinged configuration of the arm, the
arm may be
pivoted relative to the rest of the implant such that the center axis of hole
315 may be
directed to avoid placing an anchor in a bore 40 or hit the implant 25. In
other words,
because of the hinged configuration, the arm may be oriented relative to the
rest of the
implant such that the axis of hole 315 directs an anchor 40 around an implant
25 (i.e., the
axis of hole 315 will avoid intersecting the implant 25).
[00210] As illustrated in FIG. 53, which is an enlarged view of the disk-
shaped seat
310, the disk-shaped seat 310 has a plurality of arcuate members 320
distributed along
an inner circumferential boundary 325 of a rim 330 of the disk-shaped seat
310. There
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may be five or more or less arcuate members 320 distributed generally evenly
about the
inner circumferential surface 325 of the rim 330.
[00211] In one embodiment, each arcuate member 320 has ends 332 that
intersect
the inner circumferential surface 325 of the rim 330, with a center point 335
of the arcuate
member 320 that is offset or spaced apart from inner circumferential surface
325 of the
rim 330. Thus, in one embodiment, the arcuate members 320 may be deflectable
so as to
allow the head of the anchor member 30 to pass between the center points 335
of the
members 330 as the head of the anchor member 30 is seated in the seat 310. As
a result,
the arcuate members 320 can act against the head of the anchor member 30 to
prevent
the anchor member from working its way out of the bore 40 and opening 315 of
the
implant 25, thereby serving as an anchor member locking mechanism.
[00212] Other arms 300 may have an anchor member locking mechanism with a
different configuration. For example, as illustrated in FIG. 54, which is an
isometric view
of an implant 25 with another type of anchor member locking mechanism, the arm
300
may be generally cantilevered off of the proximal end 43 of the implant 25.
The arm 300
includes a free end 305 with a center hole 315 with a center axis that is
coaxially aligned
with the center axis BA of the bore 40. As illustrated in FIG. 55, which is an
enlarged view
of the free end 305, the hole 315 has a cantilevered abutment arm 335 defined
in the body
of the arm 300 via a series of parallel arcuate slots 340.
[00213] In one embodiment, a face 345 of the abutment arm 335 is
deflectable and
biased radially inward of the inner circumferential surface 350 of the hole
315 such that
when the anchor member 30 is extended through the hole 315, the face 345 abuts
against
the anchor member to prevent the anchor member from working its way out of the
bore 40
and opening 315 of the implant 25, thereby serving as an anchor member locking
mechanism.
[00214] While in the implant embodiment discussed with respect to FIGS. 4-
17 may
have a cylindrical body 45 at which the planar members 50, 55 intersect, in
other
embodiments the body 45 of the implant 25 may simply be the region 45 of the
implant 25
where the planar members 50, 55 intersect. For example, as shown in FIGS. 56-
61,
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which are, respectively, front isometric, rear isometric, side elevation,
plan, front elevation,
and rear elevation views of an implant 25, the body 45 of the implant 25 is
simply the
region 45 of the implant 25 where the planar members 50, 55 intersect.
Although not
shown in FIGS. 56-61, in one embodiment, the implant 25 has the bore 40 and
holes 70,
75 substantially as depicted and discussed with respect to the implant of
FIGS. 4-17.
Also, the rest of the features of the implant 25 of FIGS. 56-61 are
substantially as
discussed with respect to the implant 25 of FIGS. 4-17, a main difference
being the lack of
the cylindrical body 45 and the edges of adjacent intersecting surfaces of the
implant 25
of FIGS. 56-61 being rounded or arcuate as opposed to sharp or well-defined
edges, as is
the case between adjacent intersecting surfaces of the implant embodiment of
FIGS.
4-17.
[00215] Depending on the embodiment, the implant 25 may have surface
features
or texture designed to prevent migration of the implant once implanted in the
joint space.
For example, as shown in FIGS. 62-67, which are, respectively, front
isometric, rear
isometric, side elevation, plan, front elevation, and rear elevation views of
an implant 25
with anti-migration surface features 355, the body 45 of the implant 25 is
simply the region
45 of the implant 25 where the planar members 50, 55 intersect. Although not
shown in
FIGS. 62-67, in one embodiment, the implant 25 has the bore 40 and holes 70,
75
substantially as depicted and discussed with respect to the implant of FIGS. 4-
17. Also,
the rest of the features of the implant 25 of FIGS. 62-67 are substantially as
discussed
with respect to the implant 25 of FIGS. 56-61, a main difference being the
edges of
adjacent intersecting surfaces the implant 25 of FIGS. 56-61 being sharp or
well defined
edges as opposed to round or arcuate edges, as is the case between adjacent
intersecting surfaces of the implant embodiment of FIGS. 56-61.
[00216] As to particular embodiments as shown in FIGS. 56-61, and in other
embodiments as disclosed throughout, the implants described herein can be
configured
to be used as trials during certain steps of the procedure to determine
appropriate implant
sizes and to allow a physician, who is presented with a kit containing the
delivery system
20 and multiple sizes of the implant 20, to evaluate particular embodiments of
an implant
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as described herein that would be best suited to a particular patient,
application or implant
receiving space.
[00217] As shown in FIGS. 62-67, the anti-migration features 355 are
generally
evenly distributed along the planar surfaces 60, 65 of the planar members 50,
55 in a
rows and columns arrangement. The anti-migration features 355 are generally
similarly
distributed along the planar surfaces of the edges of the planar members 55.
The
anti-migration features 355 may be in the form of trapezoids, squares,
rectangles, etc. As
indicated in FIG. 66, the anti-migration features 355 may have a rectangular
cross
sectional elevation with a thickness FT of between approximately 0.2 mm and
approximately 5 mm, with one embodiment having a thickness FT of approximately
1 mm.
[00218] As another example, as shown in FIGS. 68-73, which are,
respectively,
front isometric, rear isometric, side elevation, plan, front elevation, and
rear elevation
views of an implant 25 with another type of anti-migration surface features
355, the body
45 of the implant 25 is simply the region 45 of the implant 25 where the
planar members
50, 55 intersect. Although not shown in FIGS 68-73, in one embodiment, the
implant 25
has the bore 40 and holes 70, 75 substantially as depicted and discussed with
respect to
the implant of FIGS. 4-17. Also, the rest of the features of the implant 25 of
FIGS. 68-73
are substantially as discussed with respect to the implant 25 of FIGS. 62-67,
including the
sharp or well defined edges between adjacent intersecting surfaces of the
implant 25.
[00219] As shown in FIGS. 68-73, the anti-migration features 355 are in the
form of
unidirectional serrated teeth or ridges 355, wherein the ridges 355 have a
triangular cross
sectional elevation best understood from FIGS. 70 and 71, wherein the rearward
or
trailing end of the features 355 are the truncated or vertical end of the
triangle cross
sectional elevation, and the front or leading end of the features 355 are the
point end of
the triangle cross sectional elevation. As indicated in FIG. 71, the anti-
migration features
355 with the triangular cross sectional elevations have a thickness FT of
between
approximately 0.2 mm and approximately 5 mm, with one embodiment having a
thickness
FT of approximately 1 mm, and a length FL of between approximately 0.5 mm and
approximately 15 mm, with one embodiment having a thickness FT of
approximately 2.5
mm. The triangular ridges 355 are generally evenly distributed along the
planar surfaces
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60, 65 of the planar members 50, 55 in ridges that run transverse to the
length of the
implant 25. The anti-migration features 355 are generally similarly
distributed along the
planar surfaces of the edges of the planar members 55.
[00220] In continuing reference to FIGS. 68-73, although the anti-migration
features
355 are depicted in the form of unidirectional serrated teeth or ridges 355 on
each of the
textured surfaces of the implant, the invention is not so limited and, as to
particular
embodiments, can be configured to have said features 355 arranged in multiple
directions,
unidirectional, or a combination of multiple direction on some surfaces of the
implant and
unidirectional on other surfaces of the implant. Accordingly, the features 355
can be so
arranged on the various surfaces of the implant so as to prevent undesired
migration in
particular directions due to the forces present at the sacroiliac joint 1000.
[00221] Depending on the embodiment, the implant 25 may have an edge
configuration of the planar members 55 designed to prevent migration of the
implant once
implanted in the joint space. For example, as shown in FIGS. 74-79 which are,
respectively, front isometric, rear isometric, side elevation, plan, front
elevation, and rear
elevation views of an implant 25 with anti-migration edges or ends 360, the
body 45 of the
implant 25 is simply the region 45 of the implant 25 where the planar members
50, 55
intersect. Although not shown in FIGS. 74-79, in one embodiment, the implant
25 has the
bore 40 and holes 70, 75 substantially as depicted and discussed with respect
to the
implant of FIGS. 4-17. Also, the rest of the features of the implant 25 of
FIGS. 74-79 are
substantially as discussed with respect to the implant 25 of FIGS. 56-61, with
the
exception of the anti-migration edges 360 of the implant embodiment of FIGS.
74-79.
[00222] As shown in FIGS. 74-79, the anti-migration edges 360 of the planar
members 55 are in the form of notches 365 generally evenly distributed along
longitudinally extending free edges or ends of the planar members 55. As
indicated in
FIG. 77, the notches 365 may have parallel sides 370 inwardly terminating as
an arcuate
end 375. The orientation of each notch 365 may be such that the center line NL
of the
notch 365 forms an angle NA with the center axis CA of the implant 25 that is
between
approximately 90 degrees and approximately 15 degrees, with one embodiment
having
an angle NA of approximately 45 degrees. As indicated in FIG. 77, each notch
365 may
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have a length LN between the extreme point on the arcuate end 375 and the
outer edge
boundary of the notch of between approximately 0.2 mm and approximately 10 mm,
with
one embodiment having a length LN of approximately 3 mm. Each notch 365 may
have a
width WN of between approximately 0.5 mm and approximately 20 mm, with one
embodiment having a width WN of approximately 2 mm.
[00223] As another example, as shown in FIGS. 80-85, which are,
respectively,
front isometric, rear isometric, side elevation, plan, front elevation, and
rear elevation
views of an implant 25 with another type of anti-migration edges or ends 360,
the body 45
of the implant 25 is simply the region 45 of the implant 25 where the planar
members 50,
55 intersect. Although not shown in FIGS 80-85, in one embodiment, the implant
25 has
the bore 40 and holes 70, 75 substantially as depicted and discussed with
respect to the
implant of FIGS. 4-17. Also, with the exception of its anti-migration edges
360 and its
more arcuate distal or leading end 42, the rest of the features of the implant
25 of FIGS.
80-85 are substantially as discussed with respect to the implant 25 of FIGS.
62-67,
including the sharp or well defined edges between adjacent intersecting
surfaces of the
implant 25.
[00224] As shown in FIGS. 80-85, the anti-migration edges 360 are flared
longitudinally extending free edges or ends of the planar members 55. The
edges 360
include a series of ridges 370 that are generally evenly distributed along the
length of the
edges 360 and oriented transverse to the length of the edges 360.
[00225] As indicated in FIG. 83, the ridges 370 have triangular cross
sectional
elevations with an overall height RA of between approximately 0.2 mm and
approximately
8 mm, with one embodiment having a width RA of approximately 1 mm. As
illustrated in
FIG. 85, the flared longitudinally extending free edges or ends of the planar
members 55
have rim edges 380 defining the top and bottom edges of the anti-migration
edges 360 of
the planar members 55, wherein the rim edges 380 have slopes 385 transitioning
between the planar surfaces 65 of the planar members 55 and the rim edges 380.
[00226] The edges 360 have a height EH between the edges 380 of between
approximately 0.5 mm and approximately 15 mm, with one embodiment having a
height
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EH of approximately 4 mm. The width EW of the flared edge 360 from the
beginning of
the sloped transition 385 to the face of the edge 360 is between approximately
0.2 mm
and approximately 9 mm, with one embodiment having a width EW of approximately
1
mm.
[00227] In particular embodiments, the implants with features as described
above
with respect to FIGS. 62-83 can alternatively be configured to function as a
broach or
other surgical site preparation tool that can assist in the removal of certain
tissues, for
example, cartilage or bone, during certain steps of a procedure.
[00228] To begin a detailed discussion of components of an embodiment of
the
delivery tool 20, reference is again made to FIGS. 2A-3. As shown in FIG. 2A,
the
delivery tool 20 includes a distal end 35 and a proximal end 80. The distal
end 35
supports the implant assembly 15 components 25, 30, and the proximal end 80 is
configured to be grasped and manipulated to facilitate the implantation of the
implant
assembly 15 in the sacroiliac joint.
[00229] As illustrated in FIG. 3, the delivery tool 20 further includes an
arm
assembly 85, a handle 90, an implant retainer 95, a sleeve 100 and a trocar or
guidewire
105. As shown in FIG. 18, which is a proximal isometric view of the arm
assembly 85, the
arm assembly 85 includes an implant arm 110 and an anchor arm 115 supported
off of the
implant arm 110. The implant arm 110 includes a distal end 120, a proximal end
125 and
a proximal cylindrical opening 130 of a cylindrical bore 132. The proximal end
125
includes a squared outer surface configuration 135 that facilitates a
mechanical
engagement arrangement with the handle 90 such as the mechanical arrangement
that
exists between a wrench and nut.
[00230] As shown in FIG. 19, which is a distal isometric view of the arm
assembly 85,
the distal end 120 includes cylindrical opening 137 of a cylindrical bore 132,
large planar
members, keels, or fins 140 and small planar members, keels, or fins 145, pins
150, and
a planar extreme distal face 152. As depicted in FIG. 20, which is a
longitudinal cross
section of the implant arm 110 as taken along section line 20-20 in FIG. 18,
the cylindrical
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bore 132 extends the full length of the implant arm 110 between the proximal
opening 135
and the distal opening 137.
[00231] For a detailed discussion of the interaction between the features
of the
implant arm distal end 120 and the proximal end 43 of the implant 25,
reference is now
made to FIGS. 2A and 21A and 22-24. FIG. 21A is a side elevation of the system
10
wherein the tool 20 is attached to the implant assembly 15 for delivery of the
implant
assembly 15 to the sacroiliac joint. FIG. 22 is the same view as FIG. 21A,
except shown
as a longitudinal cross section. FIG. 23 is an enlarged view of the distal
region of the
system 10 circled in FIG. 22. FIG. 24 is an enlarged cross sectional plan view
taken in a
plane 90 degrees from the section plane of FIG. 23.
[00232] As can be understood from FIG. 2A and 21A and 22-24, when the
system
is assembled for the delivery of the implant assembly 15 to the sacroiliac
joint, the
proximal end 43 of the implant 25 (see FIG. 6) is supported off of the implant
arm distal
end 120 (see FIG. 19). As can be understood from a comparison of FIGS. 6 and
19 and
more clearly depicted in FIGS. 23 and 24, the cylindrical body 45, and planar
members 50,
55 of the implant 25 and the cylindrical implant arm 110 and planar members
140, 145 of
the implant arm 110 respectively correspond with respect to both shape and
size such
that when the implant 25 is supported off of the implant arm distal end 120 as
depicted in
FIG. 2A and 21A and 22-24, the respective outer surfaces of the implant 25 and
implant
arm distal end 120 transition smoothly moving from the implant 25 to the
implant arm
distal end 120, and vice versa. Also, as shown in FIGS. 23 and 24, when the
system 10 is
assembled for the delivery of the implant assembly 15 to the sacroiliac joint,
the planar
extreme proximal face 43 of the implant 25 abuts against the planar extreme
distal face
152 of the implant arm distal end 120, the pins 150 being received in a
recessed fashion
in the lateral bores 75. The pins 150 being received in the lateral bores 75
prevents the
implant 25 from pivoting relative to the implant arm 110. The pins 150 can be
configured
to have a rectangular, circular or any other cross section and the
corresponding lateral
bores 75 can also be configured to have corresponding shapes in cross section.
[00233] Alternatively, in order to further restrict undesirable movement
between
components of a system 10, namely between that of a delivery tool 20 and an
implant 25,
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the distal face 152 of the implant arm distal end 120 can be configured to rap
around, and
can also be recessed into or grappled to, the exterior surface of the elongate
body 45, or
planar members 50, or 55 of the implant 25 a distance DE, from about 0.2 mm to
about 20
mm (e.g., lOmm), in the direction of implant distal end 42. According to
particular
embodiments, a recess can extend a distance DA from said exterior surfaces in
the
general direction of implant longitudinal axis CA, from about 0.25mm to 5mm
(e.g.,
1.25mm). In a non-limiting example of a particular embodiment, the distal face
152 of the
implant arm distal end 120 can be further configured to wrap completely or
only a portion
of the periphery of an implant by occupying only a portion, CAR, as defined by
a number
of degrees around implant longitudinal axis CA, from about 1 degree to about
180
degrees (e.g., 30 degrees). In particular embodiments, said features can be
configured to
be located in the area between the planar members 50 and 55.
[00234] As shown in FIGS. 18 and 19, the anchor arm 115 is supported off of
the
implant arm 110 at an angle and includes a proximal end 155 and a distal end
160 distally
terminating in a sleeve or collar 165 having a longitudinal center axis LCA1
that is
generally transverse to the longitudinal axis of the anchor arm 115. Collar
165 has a
length of between approximately 10 mm and approximately 60 mm (e.g., 20 mm)
disposed between collar ends 166 and 167 configured to permit and maintain
accurate
alignment of the first sleeve 100 along LCA1 during the course of the
procedure. The
anchor arm proximal end 155 intersects the implant arm 110 at a location
between the
proximal and distal ends of the implant arm.
[00235] As indicated in FIGS. 18 and 19, the implant arm 110 also includes
a
longitudinal center axis LCA2. As shown in FIG. 21A, when the system 10 is
assembled
such that the implant 25 is mounted on the distal end of the implant arm 110,
the
longitudinal center axis CA of the implant 25 is coaxially aligned with the
longitudinal
center axis LCA2 of the implant arm 110, and the longitudinal center axis BA
of the implant
bore 40 is coaxially aligned with the longitudinal center axis LCA1 of the
anchor arm collar
165. Thus, the longitudinal center axis CA of the implant 25 and the
longitudinal center
axis LCA2 of the implant arm 110 exist on a first common longitudinally
extending axis,
and the longitudinal center axis BA of the implant bore 40 and the
longitudinal center axis
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LCA1 of the anchor arm collar 165 exist on a second common longitudinally
extending
axis.
[00236] In one embodiment, the longitudinal center axis LCA1 of the anchor
arm
collar 165 forms an angle ALCA1-LCA2 with the longitudinal center axis LCA2 of
the implant
arm 110. For example, the angle ALCA1-LCA2 may be between approximately 15
degrees
and approximately 135 degrees, with one embodiment being approximately 45
degrees.
[00237] As can be understood from FIG. 21A, when the system 10 is assembled
such that the implant 25 is mounted on the distal end of the implant arm 110,
the
longitudinal center axis LCA2 of the implant arm 110 is coaxial with the
longitudinal center
axis CA of the implant 25 and the longitudinal center axis of the handle 90.
Thus, the line
of action for the insertion of the implant 25 into the sacroiliac joint is
coaxial with the
longitudinal center axes of the implant 25, implant arm 110 and handle 90.
[00238] As can be understood from the preceding discussion, in one
embodiment,
when the system 10 is assembled such that the implant 25 is mounted on the
distal end of
the implant arm 110, the angle ABA_cA may be substantially the same as the
angle
ALCA1-LCA2. Also, the longitudinal center axis BA of the implant bore 40 is
coaxially aligned
with the longitudinal center axis LCA1 of the anchor arm collar 165. Thus, as
will be
described in detail below, the anchor arm collar 165 is oriented so as to
guide drills and
other tools in creating a channel through tissue and bone leading to the
implant bore 40
when the implant 25 is positioned in the sacroiliac joint while the implant 25
is still
attached to the distal end of the implant arm 110, as shown in FIG. 21.
Additionally, the
anchor arm collar 165 is oriented so as to guide the anchor member 30 into the
implant
bore 40 when the implant 25 is positioned in the sacroiliac joint while the
implant 25 is still
attached to the distal end of the implant arm 110, as shown in FIG. 21A.
[00239] As can be understood from FIG. 21A, in one embodiment, the
above-described coaxial and angular relationships are rigidly maintained due
to the
anchor arm 115 and its collar 165 being in a fixed, non-adjustable
configuration, and the
interconnection between the proximal end of the anchor arm 115 and the implant
arm 110
being a fixed, non-adjustable configuration at least with respect to the angle
ALCA1-LCA2
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between the longitudinal center axis LCA1 of the anchor arm collar 165 and the
longitudinal center axis LCA2 of the implant arm 110. Thus, in one embodiment,
the
delivery tool 20 comes from the manufacture to the physician in a fixed, non-
adjustable
configuration having the coaxial and angular relationships articulated above
with respect
to FIG. 21A.
[00240] FIG. 21B is the same view as FIG. 21A, except of another embodiment
of
the delivery tool 20 wherein the tool 20 includes multiple anchor arms 115A-
115D that can
be coupled to specific respective locations 168A-168D on the implant arm 110
to account
for different patient sizes, yet still maintain the coaxial and angular
relationships set out
above. As shown in FIG. 21B, the delivery tool 20 may include two or more, for
example,
four, anchor arms 115A-115D, each anchor arm having a different overall
length. Despite
having different overall lengths, because each anchor arm 115A-115D is
configured to
couple to a specific respective location 168A-168D on the implant arm 110, the
longitudinal center axis LCA1 of each anchor arm collar 165A-165D is still
coaxially
aligned with the longitudinal center axis BA of the implant bore 40 when each
anchor arm
is mounted at its correct respective location 168A-168D on the implant arm
110. Thus,
although the embodiment depicted in FIG. 21B is adjustable with respect to
patient size
via the interchangeable anchor arms 115A-1150, the above-described coaxial and
angular relationships are rigidly maintained due to the anchor arms 115A-1150
and their
collars 165 being in a fixed, non-adjustable configuration, and the
interconnection
between the proximal end of the anchor arms 115A-115D and the implant arm 110
being
a fixed, non-adjustable configuration at least with respect to the angle ALCA1-
LCA2 between
the longitudinal center axis LCA1 of the anchor arm collar 165 and the
longitudinal center
axis LCA2 of the implant arm 110. Thus, although the embodiment depicted in
FIG. 21B is
adjustable with respect to the patient size via the interchangeable anchor
arms
115A-1150, the delivery tool 20 comes from the manufacture to the physician in
a fixed,
non-adjustable configuration with respect to the coaxial and angular
relationships
articulated above with respect to FIG. 21A.
[00241] Although not shown in FIG. 21B, in some embodiments, multiple
sleeves
100 may be provided with the system 10. For example, the system 10 may include
four
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anchor arms 165A-1650 of different lengths, and the system may also include
four
sleeves 100 of different lengths, each sleeve 100 being configured for use
with a specific
anchor arm. For example, since anchor arm 165D is the longest anchor arm, its
corresponding sleeve 100 may be the longest of the sleeves. Similarly, since
anchor arm
165A is the shortest anchor arm, its corresponding sleeve 100 may be the
shortest of the
sleeves.
[00242] Because of the multiple interchangeable anchor arms 165A-1650 that
are
each configured for attachment to a specific respective location 168A-1680 on
the
implant arm 110, the delivery tool 20 may be adjusted to accommodate patients
of
different sizes and still maintain the angular relationships between the
components of
system 10 that allows the anchor member 30 to be delivered into the implant
bore 40
without any further adjustment to the delivery tool. Because the angular
relationships are
rigidly maintained between the arms 110, 115, the collar 165, and the implant
bore 40
despite the anchor arms 115A-115B being interchangeable, the anchoring of the
implant
25 in the sacroiliac joint via the anchor member 30 may be achieved quickly
and safely. In
other words, because the tool does not need to be adjusted with respect to
angular
relationships, the surgery is simplified, reduced in duration, and reduces the
risk of the
anchor member 30 being driven through a nerve, artery or vein.
[00243] In some embodiments, the system 10 may be provided with two or more
tools 20, each tool having a configuration for a specific size of patient. For
example, the
tool 20 depicted in FIG. 21A may be provided for smaller patients in that
there is reduced
distance between the anchor arm collar 165 and the implant 25. As depicted in
FIG. 21C,
which is the same view of FIG. 21A, except illustrating a version of the same
tool 20
configured to accommodate larger patients, the distance between anchor arm
collar 165
and implant 25 is greater due to the anchor arm 165 being more proximally
located on the
implant arm 110 as compared to the configuration depicted in FIG. 21A. It
should be
noted that, although the version depicted in FIG. 21C is configured to
accommodate
larger patients, the coaxial and angular relationships discussed above with
respect to FIG.
21A are the same for the version depicted in FIG. 210. For the version
depicted in FIG.
21C, the sleeve 100 is substantially elongated as compared to the sleeve 100
of FIG. 21A.
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Depending on the size of the patient, the physician may select or be provided
with one of
the tool configurations shown in FIGS. 21A or 21C.
[00244] Additionally, the sleeve 100 of FIG 21C can be prevented from
undesired
migration within the anchor arm collar 165 during a procedure by utilizing a
locking
mechanism 163 in close proximity to the collar 165. As a non-limiting example,
a locking
mechanism can be configured as a fastener 163, which, in certain embodiments,
can be
threaded and rotatably advanced into the collar 165 to cause a greater amount
of friction
upon the sleeve 100.
[00245] As shown in FIGS. 25-27, which are various isometric views of the
handle
90, the handle 90 includes a gripping portion 170, a neck portion 175, a
proximal end 180,
a distal end 185, a proximal opening 190, a distal opening 195 and a bore 200
extending
longitudinally through the handle 90 between the openings 190, 195. The
proximal
opening 190 is defined in the proximal end 180, which forms the extreme
proximal portion
of the gripping portion 170. The distal opening 195 is defined in the distal
end 185, which
forms the extreme distal portion of the neck portion 175. The neck portion 175
has
multiple regions having different diameters, thereby forming a collared
configuration. The
gripping portion 170 may have a generally spherical or oval hemispheric shape.
[00246] As shown in FIG. 27, a squared inner surface configuration 205 is
defined in
a segment of the bore 195 located in the neck portion 175, the rest of the
bore 195 having
a cylindrical configuration. Thus, as can be understood from FIGS. 1, 21A and
22, when
the implant arm distal end 125 is received in the handle bore 200, the squared
inner
surface configuration 205 facilitates a mechanical engagement arrangement with
the
squared outer surface configuration 135 of the implant arm distal end 125. As
a result,
grasping the handle so as to cause the handle to pivot about its longitudinal
center axis
causes the implant arm to similarly pivot about its longitudinal center axis,
which is
generally coaxial with the longitudinal center axis of the handle. The fit
between the
squared surface configurations 135, 205 may be such as to form an interference
fit,
thereby preventing the handle from being pulled off of the implant arm distal
end without
the intentional application of substantial separating force.
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[00247] As illustrated in FIGS. 28 and 29, which are full isometric and
longitudinal
cross sectional isometric views of the implant retainer 95, the implant
retainer 95 includes
a longitudinal cylindrical member 210, T-handle 215 on a proximal end of the
longitudinal
cylindrical member 210, and an implant engagement feature 220 on a distal end
the
longitudinal cylindrical member 210. As can be understood from FIGS. 2A and
21A and
22-24, when the system 10 is assembled for the delivery of the implant
assembly 15 to the
sacroiliac joint, the longitudinal cylindrical member 210 extending through
the handle bore
200 (see FIG. 27) and implant arm bore 132 (FIG. 20) such that a distal side
of the
T-handle 215 abuts or nearly abuts with the handle proximal face or end 180
(FIG. 25)
and the implant engagement feature 220 is received in the implant center bore
70 (FIG. 6).
In one embodiment, the implant engagement feature 220 is in the form of a
threaded shaft
for engaging complementary threads in the center bore 70, thereby securing the
implant
proximal face against the implant arm distal face and the pins in the lateral
bores, as
depicted in FIGS. 22-24. In other embodiments, the implant engagement feature
220 and
the center bore 70 are configured so as to form an interference fit between
the two such
that an intentional separating force is required to remove the implant
engagement feature
from within the center bore and allow the release of the implant from the
distal end of the
implant arm, as indicated in FIG. 2B.
[00248] FIG. 30A is an isometric view of a sleeve 100 that is configured to
be
received in the anchor arm collar 165, as can be understood from FIGS. 2A,
21A, and
22-23. The sleeve 100 may have a tubular portion 225 that extends from a plate
230 and
defines a lumen 226 extending the length of the tubular portion 225. As
indicated in FIG.
30B, which is a longitudinal cross section of one embodiment of the sleeve
100, the
sleeve 100 is formed of multiple sleeve portions 100A-1000 nested together
such that the
tubular portions 225A-225B are concentrically arranged and the plates 230A-
230B are
stacked. As each sleeve portion 100A-1000 has a tubular portion 225A-225B with
a
different diameter, the sleeve portions 100A-1000 can be employed as needed to
dilate
an incision opening or guide different diameter guidewires, trocars, drills,
etc. in the
direction of the implant bore 40.
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[00249] FIG. 31 is an isometric view of a trocar, guidewire, drill,
screwdriver, etc.
that may be inserted through the lumen 226 of the tubular portion 225 in
gaining access to,
or driving the anchor member 30 into, the implant bore 40 when the implant 25
is
positioned in the sacroiliac joint via the distal end of the implant arm 110.
[00250] To begin a detailed discussion of a second embodiment of the system
10,
reference is made to FIGS. 32-33. FIG. 32 is an isometric view of the system
10, and FIG.
33 is the same view as FIG. 32, except the system 10 is shown exploded to
better
illustrate the components of the system 10.
[00251] As can be understood from FIGS. 32 and 33, the system 10 includes a
delivery tool 20 and an implant assembly 15 for implanting at the sacroiliac
joint via the
delivery tool 20, the implant assembly 15 being for fusing the sacroiliac
joint. As indicated
in FIG. 33, the implant assembly 15 includes an implant 25 and an anchor
element 30
(e.g., a bone screw or other elongated body). In one embodiment, the implant
assembly
15 is the same as that described above with respect to FIGS. 4-17. As
discussed below in
greater detail, during the implantation of the implant assembly 15 at the
sacroiliac joint,
the implant 25 and anchor element 30 are supported by a distal end 35 of the
delivery tool
20, as illustrated in FIG. 32. The delivery tool 20 is used to deliver the
implant 25 into the
sacroiliac joint space. The delivery tool 20 is then used to cause the anchor
element 30 to
extend through the ilium, sacrum and implant 25 generally transverse to the
sacroiliac
joint and implant 25. The delivery tool 20 is then decoupled from the
implanted implant
assembly 15.
[00252] As shown in FIG. 32, the delivery tool 20 includes a distal end 35
and a
proximal end 80. The distal end 35 supports the implant assembly 15 components
25, 30,
and the proximal end 80 is configured to be grasped and manipulated to
facilitate the
implantation of the implant assembly 15 in the sacroiliac joint.
[00253] As illustrated in FIG. 33, the delivery tool 20 further includes an
arm
assembly 85, a handle 90, an implant retainer 95, and a trocar or guidewire
105. As
shown in FIG. 33 and also in FIG. 34, which is a side elevation of the system
10, the arm
assembly 85 includes an implant arm 110 and an anchor arm 115.
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[00254] As shown in FIG. 35, which is a proximal isometric view of the
implant arm
110, the implant arm 110 includes a distal end 120, a proximal end 125 and a
proximal
cylindrical opening 130 of a cylindrical bore 132. The proximal end 125
includes a
squared outer surface configuration 135 that facilitates a mechanical
engagement
arrangement with the handle 90 such as the mechanical arrangement that exists
between
a wrench and nut. As the handle 90 is the same as described above with respect
to FIGS.
25-27, the handle 90 receives and mechanically interlocks with the distal
region of the
implant arm 110 as described above with respect to FIG. 22.
[00255] As with the implant arm 110 discussed above with respect to FIG. 19
and as
can be understood from FIG. 34, the distal end 120 of the implant arm 110
includes a
cylindrical opening 137 (see FIG. 19) of a cylindrical bore 132, large planar
members,
keels, or fins 140 and small planar members, keels, or fins 145, pins 150, and
a planar
extreme distal face 152 (see FIG. 19). Just as explained with respect to FIG.
20 above,
the cylindrical bore 132 of the embodiment depicted in FIG. 34 extends the
full length of
the implant arm 110 between the proximal opening 135 and the distal opening
137.
[00256] As the retaining member 95 of the embodiment of FIG. 33 is the same
as
described above with respect to FIGS. 28-29, the retainer member 95 extends
through
the handle 90 and implant arm 110 to mechanically interlock with the implant
center bore
70 as described above with respect to FIGS. 22-24. Also, the configuration of
the distal
end 120 of the implant arm 110 of FIG. 35 is the same as the configuration of
the distal
end 120 of the implant arm 110 of FIG. 19. Accordingly, the distal end 120 of
the implant
arm 110 of FIG. 35 interacts with the proximal end of the implant 25 as
describe above
with respect to FIGS. 22-24.
[00257] As indicated in FIG. 35, the implant arm 110 includes pivot pins
235 on
opposite sides of the implant arm 110, the pivot pins 235 having a pivot axis
PA that is
perpendicular to the plane in which the implant bore 40 passes through the
implant 25. In
other words, the pivot axis PA is perpendicular to the longitudinal center
axis LCA2 of the
implant arm 110 and contained within the same plane as the longitudinal center
axis LCA2
of the implant arm 110. The pivot pins 235 are located on the implant arm 110
near the
distal end of the handle 90.
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[00258] As illustrated in FIG. 36, which is an isometric view of the anchor
arm 115,
the anchor arm 115 includes a proximal end 155 and a distal end 160 distally
terminating
in a sleeve or collar 165 that is arcuate and substantially extended as
compared to the
collar 165 of the embodiment depicted in FIG. 18. The arcuate and extended
collar 165
has an arcuate longitudinal center axis LCA1 that is generally transverse to
the
longitudinal axis of the anchor arm 115. A lumen 236 extends the length of the
collar 165
to daylight in openings at both ends of the collar 165.
[00259] As shown in FIG. 36, the anchor arm proximal end 155 includes
notches
240, which, as can be understood from FIGS. 32 and 34, receive the respective
pivot pins
235. As a result, the anchor arm 115 is pivotally supported off of the implant
arm 110 via
the notches 240 at the anchor arm proximal end 155 pivotally receiving the
pivot pins 235
of the implant arm 110.
[00260] As can be understood from FIGS. 32-34, an arcuate member 105 can be
inserted in the lumen 236 of the arcuate extended collar 165. The curvature of
the
arcuate member 105 matches the curvature of the lumen 236 of the arcuate
collar 165.
The arcuate member 105 may be a trocar, guidewire, drill, screwdriver, etc.
that may be
inserted through the lumen 236 of the collar 165 in gaining access to, or
driving the
anchor member 30 into, the implant bore 40 when the implant 25 is positioned
in the
sacroiliac joint via the distal end of the implant arm 110. As indicated by
the arrow A in
FIG. 34, the arcuate member 105 is slideably displaceable through the arcuate
length of
the collar 165. Also, as indicated by arrow B, the anchor arm 110 is pivotal
about the pivot
pins 235.
[00261] As indicated in FIG. 35, the implant arm 110 includes a
longitudinal center
axis LOA2. As shown in FIG. 34, when the system 10 is assembled such that the
implant
25 is mounted on the distal end of the implant arm 110, the longitudinal
center axis CA of
the implant 25 is coaxially aligned with the longitudinal center axis LCA2 of
the implant
arm 110, and the longitudinal center axis BA of the implant bore 40 is
coaxially aligned
with the longitudinal center axis LOA, of the anchor arm collar 165. In other
words, in the
context of the embodiment of FIG. 34, the arcuate longitudinal center axis
LCA, extends
to be coaxially aligned with the longitudinal center axis BA of the implant
bore 40. In one
41
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embodiment, as indicated in FIG. 34, the longitudinal center axis LCA1 of the
anchor arm
collar 165 has an arm radius RARm that extends into coaxial alignment with the
longitudinal
center axis BA of the implant bore 40. For example, the arm radius RARNA may
be between
approximately 50 mm and approximately 300 mm, with one embodiment being
approximately 160 mm.
[00262] As can be understood from FIG. 34, when the system 10 is assembled
such
that the implant 25 is mounted on the distal end of the implant arm 110, the
longitudinal
center axis LCA2 of the implant arm 110 is coaxial with the longitudinal
center axis CA of
the implant 25 and the longitudinal center axis of the handle 90. Thus, the
line of action
for the insertion of the implant 25 into the sacroiliac joint is coaxial with
the longitudinal
center axes of the implant 25, implant arm 110 and handle 90. Thus, as will be
described
in detail below, the anchor arm collar 165 is oriented so as to guide drills
and other tools in
creating a channel through tissue and bone leading to the implant bore 40 when
the
implant 25 is positioned in the sacroiliac joint while the implant 25 is still
attached to the
distal end of the implant arm 110, as shown in FIG. 34. Additionally, the
anchor arm collar
165 is oriented so as to guide the anchor member 30 into the implant bore 40
when the
implant 25 is positioned in the sacroiliac joint while the implant 25 is still
attached to the
distal end of the implant arm 110, as shown in FIG. 32.
[00263] Because the tool embodiment depicted in FIG. 32 has an anchor arm
115
that is pivotally supported off of the implant arm 110 and the anchor arm
collar 165 is
arcuate and slideably receives an arcuate trocar, etc. 105, the tool 20 is
able to account
for different patient sizes, yet still maintain the coaxial and angular
relationships set out
above. In other words, regardless of whether the anchor arm 115 is pivoted so
as to
move the anchor arm distal end 160 closer to or further away from the implant
bore 40 to
accommodate a smaller or larger patient, the trocar 105 can be withdrawn from
or
extended towards the implant bore 40 as needed to deliver the anchor 30 to the
implant
bore 40, the trocar 105 being maintained in the necessary coaxial alignment of
the
longitudinal axis LCA1 of the collar 165 with the longitudinal axis BA of the
implant bore
40.
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[00264] Because the angular relationships are rigidly maintained between
the trocar
105 and the implant bore 40 despite the anchor arm 115 being pivotal relative
to the
implant arm, the anchoring of the implant 25 in the sacroiliac joint via the
anchor member
30 may be achieved quickly and safely. In other words, because the tool does
not need to
be adjusted with respect to angular relationships, the surgery is simplified,
reduced in
duration, and reduces the risk of the anchor member 30 being driven through a
nerve,
artery or vein.
[00265] To begin a detailed discussion of a third embodiment of the system
10,
reference is made to FIGS. 37-40. FIGS. 37 and 38 are different isometric
views of the
system 10. FIG. 39 is the same view as FIG. 37, except the system 10 is shown
exploded
to better illustrate the components of the system 10. FIG. 40 is a side
elevation of the
system wherein the tool is attached to the implant assembly for delivery of
the implant
assembly to the sacroiliac joint.
[00266] As can be understood from FIGS. 37-40, the system 10 includes a
delivery
tool 20 and an implant assembly 15 for implanting at the sacroiliac joint via
the delivery
tool 20, the implant assembly 15 being for fusing the sacroiliac joint. As
indicated in FIG.
39, the implant assembly 15 includes an implant 25 and an anchor element 30
(e.g., a
bone screw or other elongated body).
[00267] As can be understood from a comparison of FIGS. 2A-3 to FIGS 37-40,
the
delivery tool 20 of FIGS. 2A-3 is the same as the delivery tool 20 of FIGS. 37-
40. Thus,
for a complete description of the delivery tool 20 of FIGS. 37-40 and its
components,
namely, the arm assembly 85, handle 90, implant retainer 95, a trocar or
guidewire 105,
and multiple nested sleeves 1 00, refer back to the corresponding discussion
given above
with respect to FIGS. 2A-3 and 18-31.
[00268] As indicated in FIGS. 37-40, the system 10 includes an implant
assembly
15 with an implant 25 similar the implant 25 discussed above with respect to
FIGS. 4-18,
except the implant 25 of FIGS. 37-40 also includes a guide arm 265. To begin a
detailed
discussion of components of the embodiment of the implant 25 of FIGS. 37-40,
reference
is made to FIGS. 41-50. FIGS. 41-44 are various isometric views of the implant
25. FIGS.
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45-46 are opposite plan views of the implant 25, and FIGS. 47-50 are various
elevation
views of the implant.
[00269] A comparison of FIGS. 41-50 to FIGS. 5-18 reveals that the two
implant
embodiments are the same, except the implant embodiment of FIGS. 41-50 has a
guide
arm 265. Thus, for a complete description of the features of the implant 25
other than the
guide arm 265, which is discussed below, refer back to the corresponding
discussion
given above with respect to FIGS. 5-18.
[00270] As shown in FIGS. 41-45 and 46-50, the guide arm 265 includes a
longitudinally extending member 270 and a guide portion 275. The guide arm 265
is
cantilevered off of a side of the implant near the proximal or trailing end 43
of the implant
25. Thus, the guide arm 265 includes an attached end 280, which is attached
to, or
extends from, the implant proximal end 43, and a free end 285, which defines
the guide
portion 275.
[00271] The longitudinally extending member 270 may be in the form of a
planar
member or other shaped member. As illustrated in FIG. 45, the longitudinal
axis LA of the
member 270 is generally coplanar with the longitudinal axis CA of the implant
body 45.
However, as indicated in FIG. 48, the longitudinal axis LA of the member 270
forms an
angle ALA_cA with the longitudinal axis CA of the implant body 45. For
example, the angle
ALA-CA may be between approximately 5 degrees and approximately 60 degrees,
with one
embodiment being approximately 40 degrees.
[00272] As illustrated in FIGS. 41-45 and 47-50, the guide portion 275 is
in the form
of a collar defining a central hole 290. As indicated in FIG. 47, the member
270 has an
overall length AD from its intersection with the rest of the implant to the
tip of the free end
285 of between approximately 5 mm and approximately 60 mm, with one embodiment
being approximately 20 mm. Also, the center axis GA of the hole 290 is
coaxially aligned
with the center axis BA of the bore 40. The overall length AE from the
intersection of the
member 270 with the rest of the implant to the center axis GA is between
approximately 2
mm and approximately 58 mm, with one embodiment being approximately 17 mm.
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[00273] Since the center axis GA of the hole 290 is coaxially aligned with
the center
axis BA of the bore 40, when the system 10 is assembled such that the implant
25 is
mounted on the distal end of the implant arm 110 with the longitudinal center
axis LCA2 of
the implant arm 110 coaxial with the longitudinal center axis CA of the
implant 25, the
respective longitudinal axes LCAl, BA and GA of the anchor arm collar 165, the
bore 40
and the guide hole 290 are coaxially aligned, as can be understood from FIG.
40. Thus,
when the implant body 45 is located in the sacroiliac joint and the guide
collar 275 of the
implant 25 is located near or against bone adjacent to the sacroiliac joint,
the anchor
member 30 may be accurately driven through the guide hole 290, through the
bone and
through the implant bore 40 to anchor the implant at the sacroiliac joint in
such a manner
to allow the implant to fuse the joint.
[00274] In one embodiment, the implant 25 may be machined, molded, formed,
or
otherwise manufactured from stainless steel, titanium, ceramic, polymer,
composite or
other biocompatible materials. The anchor member 30 may be machined, molded,
formed or otherwise manufactured from similar biocompatible materials. As an
example,
implant 25, anchor 30 or delivery tool 20 may be manufactured by laser or
electron beam
additive manufacturing with, for example, EOSINT P 800 or EOSINT M 280
(available
from EOS GmbH, Electro Optical Systems, Robert-Stirling-Ring 1, D-82152
Krailling /
Munich), or Arcam Al (available from Arcam AB (publ.), Krokslatts Fabriker
27A, SE-431
37 Molndal Sweden)
[00275] For the delivery tools 20 depicted in FIGS. 2A, 21A, 210, 32, 37,
and 40, the
handle 90 and arm assembly 85 are coupled together so as to not allow
rotational
movement relative to each other, and the implant retainer 95 is rotationally
displaceable
within the handle 90 and arm assembly 85. In other embodiments of the tool 20,
the
handle 90 and implant retainer 95 are coupled together so as to rotate as a
unit relative to
the arm assembly 85. An example of such an embodiment is illustrated in FIG.
86, which
is an isometric view of the delivery tool 20.
[00276] As shown in FIG. 86, the delivery tool 20 includes a distal end 35
and a
proximal end 80. As shown in FIGS. 87-88, which are generally opposite
isometric views
of the delivery tool 20 in an exploded state, the tool 20 further includes an
arm assembly
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85, a handle 90, an implant retainer 95, and a collar assembly 400. The tool
20 may also
include a sleeve 100 and a trocar or guidewire 105 as discussed above with
respect to the
embodiment of FIG. 3.
[00277] As can be understood from FIGS. 86-88, the arm assembly 85 includes
an
implant arm 110 and an anchor arm 115 supported off of the implant arm 110.
The
implant arm 110 has a two-piece construction of an inner sleeve 110A and an
outer
sleeve 110B. The implant arm inner sleeve 110A includes a distal end 120, a
proximal
end 125, a proximal cylindrical opening 130 of a cylindrical bore 132, and a
distal
cylindrical opening 137 of the bore 132. The cylindrical bore 132 extends the
full length of
the implant arm inner portion 110A between the proximal opening 135 and the
distal
opening 137. Longitudinally extending raised ribs 405 are radially distributed
about the
outer circumferential surface of the implant arm inner portion 110A. The
longitudinal ribs
405 distally terminate by intersecting a raised circumferential ring 410 on
the outer
circumferential surface of the inner implant arm portion 110A. A groove 415 is
circumferentially extends about the outer circumference of the implant arms
inner portion
110A. The distal end 120 of the implant arm inner portion 110A also includes
large planar
members, keels, or fins 140 and small planar members, keels, or fins 145, pins
150, and
a planar extreme distal face 152 similar to that discussed above with respect
to the
embodiment of FIG. 2A.
[00278] As illustrated in FIGS. 87-88, the implant arm outer portion 110B
includes a
distal end 420, a proximal end 425, a proximal cylindrical opening 430 of a
cylindrical bore
432, and a distal cylindrical opening 437 of the bore 432. The cylindrical
bore 432
extends the full length of the implant arm outer portion 110B between the
proximal
opening 435 and the distal opening 437. Longitudinally extending grooves 440
are
radially distributed about the inner circumferential surface of the bore 432
in an
arrangement that matches the longitudinal raised ribs 405 of the implant arm
inner portion
110A such that the ribs 405 are received in the grooves 440 in a mated
arrangement
when the inner portion 110A is received in the bore 432 of the outer portion
110B. The
anchor arm 115 extends off the implant arm outer portion 110B at an angle as
described
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above with respect to the previously discussed embodiments. The anchor arm 115
terminates at its free end in a collar 165 similar to those already discussed
above.
[00279] As shown in FIGS. 87 and 88, the implant retainer 95 includes a
proximal
end 215, a distal end 220, and a lumen 445 extending the full length of the
implant
retainer 95. The proximal end 215 includes a squared, pentagonal or hexagonal
outer
surface configuration 450 that facilitates a mechanical engagement arrangement
with the
handle 90 such as the mechanical arrangement that exists between a wrench and
nut. A
ring 451 radial extends from the retainer 95 at the distal edge of the
squared, pentagonal
or hexagonal configuration 450. The distal end 220 may be threaded or
otherwise
configured to engage a proximal end of anyone of the implants 25 disclosed
herein.
[00280] As illustrated in FIGS. 87 and 88, the collar assembly 400 includes
a helical
spring 455, rings 460A and 460B, washer 460C, retainer balls 461, and a
retaining collar
465. As shown in FIG. 89, which is an isometric view of the handle 90, a
cylindrical neck
portion 470 of the handle 90 includes a shoulder 476 which slopes down to a
circumferential groove 475 and a pair of holes 480 defined in the outer
circumferential
surface of the neck 470.
[00281] As indicated in FIG. 90, which is an exploded isometric view of the
retaining
collar 465 and handle 90 shown in longitudinal cross section, the holes 480
extend
through the cylindrical wall 485 that defines the neck 470 and a cylindrical
void 487 within
the neck. A squared, pentagonal or hexagonal inner surface configuration 490
is defined
in the handle 90 distal the cylindrical void 487 to receive in a mating
arrangement the
complementarily shaped outer configuration 450 of the proximal end of the
implant
retainer 95. A lumen 495 extends from a proximal end of the handle to open
into the
squared, pentagonal or hexagonal inner surface configuration 490.
[00282] As shown in FIG. 90, the retaining collar 465 includes a proximal
end 500, a
distal end 505, an outer circumferential surface 510 and an inner
circumferential surface
515 that defines the hollow interior of the collar 517. The outer
circumferential surface
510 extends radially outward to form a rim 520 near the proximal end 500. The
inner
circumferential surface 515 has a stepped and ramped configuration.
Specifically,
47
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working distal to proximal, the inner circumferential surface 515 includes a
proximal inner
ring 525 separated from an intermediate inner ring 530 by a proximal large
diameter
region 535 separated from a small diameter region 540 by a ramped surface 545.
Proximal the intermediate inner ring 530 is another large diameter region 550
bordered on
its proximal boundary by a groove 555.
[00283] As can be understood from FIG. 91, which is a longitudinal cross
section of
the delivery tool 20 when assembled as shown in FIG. 86, the implant arm inner
portion
110A is received in the implant arm outer portion 110B such that the ribs 405
are matingly
received in the corresponding slots 440 and the ring 410 abuts against the
distal end 420
of the outer portion 110B. The implant retainer 95 extends through the inner
portion 110A
such that the distal end 220 of the implant retainer distally extends from the
distal end 120
of the inner portion 110A and the ring 451 abuts against the proximal end 125
of the inner
portion 110A. The proximal ends of the inner portion 110A and retainer 95 are
received in
the volume 487 (see FIG. 90) of the neck 470, the squared, pentagonal, or
hexagonal
portion 450 of the retainer 95 matingly received in the complementarily shaped
volume
490 of the neck such that the ring 451 abuts against the step in the neck
between the
volume 490 of the neck and the rest of the volume of the neck distal thereto.
The distal
end of the neck 470 abuts against the proximal end 425 of the outer portion
110B.
[00284] As illustrated in FIG. 91, a first lock ring 460A is received in
the groove 555
in the collar 465. A second lock ring 460B is received in the circumferential
groove 475. A
washer 460C is received on the neck 470 and abuts shoulder 476, which prevents
washer
460C from advancing proximally beyond shoulder 476, and washer 460C is held in
place
distally by second lock ring 460B.Helical spring 455 circumferentially extends
about the
neck 470 between the washer 460C and the intermediate inner ring 530 of the
collar 465.
Thus, the spring biases the collar 465 distally on the neck 470. First lock
ring 460A
prevents collar 465 from distal disengagement from neck 470; the ring 460A,
due to the
forces exerted by a compressed spring 455abuts washer 460C under normal
conditions
until manipulation by a medical person acting to move collar 465 proximally
which in turn
moves first lock ring 460A proximally thereby creating a further distance
between first lock
ring 460A and washer 460C.
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[00285] As depicted in FIG. 91, neck holes 480 can be configured to have a
sufficient diameter to allow the retaining balls 461 to enter from the opening
nearest the
outer circumferential surface of the neck 470 and to be seated within holes
480, the
configuration further allowing a portion of the retaining balls 461 to extend
into the
cylindrical void 487 such to allow sufficient engagement with groove 415 as
further
described below. The neck holes 480 can be further configured, as depicted in
FIG. 91, to
have a slight reduction in their diameter, the reduction of diameter occupying
a small
portion of the holes 480 nearest the cylindrical void 487, thereby allowing
for a
configuration between neck 470, neck holes 480 and retaining balls 461 such
that the
retaining balls 461 are resistant to completely entering cylindrical void 487
after the
removal of inner portion of the implant retainer 95 and implant arm inner
portion 110A.
The balls 461 are each held in their respective holes 480 in the neck 470 by
the balls 461
being trapped between the neck holes 480 and inner circumferential surface of
the collar
465. Therefore, when the collar 465 is biased distally on the neck, the balls
461 are
inwardly forced by the reduced diameter region 540 to lock into the groove 415
of the
inner portion 110A, retaining the proximal end of the anchor arm 110 in the
handle/collar
assembly. When the collar 465 is pulled proximally by a medical person using
the tool 20,
the balls 461 are exposed to the large diameter region 535, allowing the balls
461
sufficient play to radially outwardly move in the holes 480 to allow the balls
to escape the
groove 415, thereby allowing the proximal end of the anchor arm 110 to be
removed from
the handle/collar assembly.
[00286] As shown in FIG. 91, the lumens 495 and 445 are aligned to make one
continuous lumen through the assembled tool 20. Thus, the tool 20 can be fed
over a
guidewire, stylet, needle or etc., or such implements can be fed through the
lumen. Also,
a bone paste, in situ curable biocompatible material, or similar material can
be fed
through the lumen to an implant 25 positioned in the joint via the tool.
[00287] As can be understood from FIGS. 86-91, the collar assembly 400
retains
the proximal end of the implant arm 110 in the neck of the handle 90. The
collar assembly
400 can be displaced proximally on the neck of the handle 90 to allow the
proximal end of
the implant arm 110 to be removed from the neck of the handle. When the
implant arm
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1 10 is coupled to the handle 90, the portions 110A and 110B of the implant
arm 110 are
locked together and prevented from displacing relative to each other, but the
handle 90
and retainer 95 can be caused to rotate as a unit relative to the implant arm
110 to cause
the distal end 220 of the retainer 95 engage or disengage the implant 25 as
desired.
Accordingly, the configuration allows for the removal of a handle 90 during
the course of a
procedure while allowing the retainer 95 to maintain engagement with implant
25 as
desired.
[00288] Additionally, as a non-limiting example, according to particular
embodiments, a reversible locking ratcheting mechanism can be employed to
prevent
undesired rotation of the handle and other components which could loosen the
connection between implant 25 and retainer 95.
[00289] As illustrated in FIG. 92, which is a side view of an implant
retainer 95
similar to that described with respect to FIGS. 86-91, except having a
modified distal end
220. Specifically, the embodiment of FIG. 92 has T-shaped distal end 220. In
one
embodiment, the T-shaped distal end 220 includes a cylindrical center portion
220A and
ears or tabs 220B oppositely positioned on the center portion 220A from each
other.
[00290] FIGS. 93-94 are, respectively, longitudinal and transverse cross
sectional
views of an implant 25 with an engagement hole 70 configured to
complementarily
engage with the T-shaped distal end 220 of the retainer 95 of FIG. 92. As
illustrated in
FIGS. 93-94, the hole 70 includes a cylindrical longitudinally extending
center portion 70A
with longitudinally extending grooves 70B located oppositely from each other.
Inner
radially extending grooves 70C intersect the distal ends of the grooves 70B.
[00291] As shown in FIG. 95, which is the same view as FIG. 93, except with
the
retainer 95 received in the hole 70, the cylindrical retainer portion 220A is
received in the
cylindrical hole portion 70A, and the retainer tab portions 220B are received
in the hole
grooves 70B. Once the distal end 220 of the retainer 95 is sufficiently
received in the hole
70 such that the retainer tab portions 220B are aligned with the associated
radially
extending grooves 70C as illustrated in FIG. 95, the retainer 95 can be
rotated within the
hole 70 to cause the tab portions 220B to move into the radially extending
grooves 70C,
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thereby locking the distal end 220 of the retainer 95 in the hole 70 of the
implant 25.
Grooves 70C can be configured such as to form an interference fit, thereby
preventing
retainer 95 from being separated from the implant 25 without the intentional
application of
substantial rotational separating force. Reversing the rotation of the
retainer can cause
the tab portions 220B to exit the radial grooves 70C, thereby unlocking the
retainer distal
end from the implant hole. Alternatively, according to particular embodiments,
as a
non-limiting example, radially extending grooves 700 can be configured to have
at least
one ramped surface, which upon rotation of retainer 95 into the grooves 700,
urges the
distal end 220 a distance further in the direction of distal end 42 of implant
25 thereby
creating increased friction between ring 45 of retainer 95 and proximal end
125 of 110A
thereby preventing undesirable reverse rotation of the retainer without the
intentional
application of substantial rotational separating force, which otherwise could
lead to an
unlocking of the retainer distal end from the implant hole.
[00292] As illustrated in FIG. 93, in one embodiment, the implant 25 may
include a
lumen 600 extending the length of the implant through the anchor hole 40 and
the retainer
engagement hole 70. Such a lumen 600 may serve to receive a guidewire or
stylet there
through. Such a lumen 600 may serve to receive an injection of bone paste
material, or
other biocompatible material.
[00293] To begin a detailed discussion of a fourth embodiment of the system
10,
reference is made to FIGS. 109 and 110. FIG. 109 is an isometric view of the
system 10
wherein the tool 20 is attached to the implant 25 for delivery of the implant
to the sacroiliac
joint. FIG. 110 is a view of the system 10 wherein the implant 25 and anchor
arm 115 are
shown in plan view.
[00294] As can be understood from FIGS. 109-110, the system 10 includes a
delivery tool 20 and an implant 25 for implanting at the sacroiliac joint via
the delivery tool
20, the implant 25 being for fusing the sacroiliac joint. As can be understood
from a
comparison of FIGS. 109 and 86, the tool embodiment of FIG. 109 is
substantially similar
to the tool embodiment of FIG. 86, except the tool embodiment of FIG. 109 has
an anchor
arm 115 that distally ends in multiple anchor collars 165a-165d.
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[00295] As can be understood from a comparison of FIGS. 109 and 7, the
implant
embodiment of FIG. 109 is substantially similar to the implant embodiment of
FIG. 7,
except the implant embodiment of FIG. 109 has multiple bores 40a-40b.
[00296] As illustrated in FIGS. 109-110, the anchor collars 165 may include
two
linearly aligned center collars 165a and 165b, and a lateral anchor collar
165c and 165d
may be located on either side of the most proximal center collar 165b. As
indicated in FIG.
110, the two center collars 165a and 165b may be axially aligned with the
respective
bores 40a and 40b of the implant 25 when the implant 25 is supported off of
the distal end
of the implant arm 110 of the tool 20. As a result, an anchor member 30 (see,
for example,
FIG. 4) may be delivered into each of the bores 40a and 40b via the respective
anchor
collars 165a and 165b. The lateral anchor collars 165c and 165d may be
employed to
deliver yet additional anchor members 30 to additional anchor member receiving
features
(e.g., bores, etc.) existing on, or extending from the sides of, the implant
25, where such
additional anchor member receiving features are present on the implant 25.
Alternatively,
lateral collars 165c and 165d can be configured to deliver additional anchor
members 30
into the bone of the ilium and sacrum while not passing through a bore 40
(i.e.,
preconfigured to place anchor members 30 immediately adjacent the longitudinal
side
edges of the implant 25.
[00297] To begin a discussion regarding the methodology associated with
employing any of the above-described delivery tools 20 in implanting any of
the
above-described implants 25 in the sacroiliac joint 1000 of a patient 1001,
reference is
first made to FIGS. 96A-98B to identify the bone landmarks adjacent, and
defining, the
sacroiliac joint 1000. FIG. 96A is a right lateral side view of a hip region
1002 of a patient
1001 lying prone, wherein the soft tissue 1003 surrounding the skeletal
structure 1006 of
the patient 1001 is shown in dashed lines. FIG. 96B is an enlarged view of the
hip region
1002 of FIG. 96A. As illustrated in FIGS. 96A and 96B, a lateral view of the
patient's hip
region 1002 reveals certain features of the ilium 1005, including the anterior
superior iliac
spine 2000, the iliac crest 2002, the posterior superior iliac spine 2004, the
posterior
inferior iliac spine 2006, the greater sciatic notch 2008 extending from the
posterior
inferior iliac spine 2006 to the ischial spine 2010, and the tubercle of iliac
crest 2012. The
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sacroiliac joint articular region 1044 is shown in dashed lines. A posterior
inferior access
region 2016 of the sacroiliac joint articular region 1044 has a superior end
2018 on the
sacroiliac joint line 2019 that is between approximately 0 mm and
approximately 40 mm
inferior the posterior inferior overhang 2020 of the posterior superior iliac
spine 2004. The
posterior inferior access region 2016 of the sacroiliac joint articular region
1044 has an
inferior end 2022 on the sacroiliac joint line that is at approximately the
intersection of the
posterior inferior iliac spine 2006 with the lateral anterior curved boundary
2024 of the
sacrum 1004. In other words, the posterior inferior access region 2016 of the
sacroiliac
joint articular region 1044 has an inferior end 2022 on the sacroiliac joint
line that is at
approximately the superior beginning of the greater sciatic notch 2008.
[00298] FIG. 97A is a lateral-posterior view of the hip region 1002 of the
patient
1001 of FIG. 96A, wherein the patient 1001 is lying prone and the soft tissue
1003
surrounding the skeletal structure 1006 of the patient 1001 is shown in dashed
lines. FIG.
97B is an enlarged view of the hip region 1002 of FIG. 97A. As shown in FIGS.
97A and
97B, a lateral-posterior view of the patient's hip region 1002 reveals the
same features of
the sacrum 1004 and ilium 1005 as discussed above with respect to FIGS. 96A
and 96B,
except from another vantage point. The vantage point provided via FIGS. 97A
and 97B
provides further understanding regarding the posterior inferior access region
2016 of the
sacroiliac joint articular region 1044 and superior end 2018 and inferior end
2022 of the
posterior inferior access region 2016 relative to nearby anatomical features,
such as, for
example, the posterior inferior overhang 2020 of the posterior superior iliac
spine 2004,
the intersection of the posterior inferior iliac spine 2006 with the lateral
anterior curved
boundary 2024 of the sacrum 1004, and the superior beginning of the greater
sciatic
notch 2008.
[00299] FIG. 98A is a posterior view of the hip region 1002 of the patient
1001 of FIG.
96A, wherein the patient 1001 is lying prone and the soft tissue 1003
surrounding the
skeletal structure 1006 of the patient 1001 is shown in dashed lines. FIG. 98B
is an
enlarged view of the hip region 1002 of FIG. 98A. As shown in FIGS. 98A and
98B, a
posterior view of the patient's hip region 1002 reveals the same features of
the sacrum
1004 and ilium 1005 as discussed above with respect to FIGS. 96A and 96B,
except from
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yet another vantage point. The vantage point provided via FIGS. 98A and 98B
provides
yet further understanding regarding the posterior inferior access region 2016
of the
sacroiliac joint articular region 1044 and superior end 2018 and inferior end
2022 of the
posterior inferior access region 2016 relative to nearby anatomical features,
such as, for
example, the posterior inferior overhang 2020 of the posterior superior iliac
spine 2004,
the intersection of the posterior inferior iliac spine 2006 with the lateral
anterior curved
boundary 2024 of the sacrum 1004, and the superior beginning of the greater
sciatic
notch 2008.
[00300] Now that the relevant anatomical landmarks have been identified
with
respect to FIGS. 96A-98B, the methodology associated with employing any of the
above-described delivery tools 20 in implanting any of the above-described
implants 25 in
the sacroiliac joint 1000 of a patient 1001 can be discussed. In doing so,
reference will be
made to FIGS. 99A-99P, which are each a step in the methodology and
illustrated as the
same transverse cross section taken in along a plane extending medial-lateral
and
anterior posterior along section line 99-99 in FIG. 98B. In this cross
section, articular
surfaces 1016 are covered by a thick layer of articular cartilage with a joint
space existing
between them, the Figures 99A-99P are simplified for illustrative purposes and
do not
show these features to scale. Now referring primarily to FIG. 99A, an
embodiment of the
method can include the step of placing a patient under sedation prone on a
translucent
operating table (or other suitable surface). The sacroiliac joint 1000 can be
locally
anesthetized to allow for injecting a radiographic contrast 1046 (as a non-
limiting example,
lsoview 300 radiographic contrast) under fluoroscopic guidance into the
inferior aspect of
the sacroiliac joint 1000 to outline the articular surfaces 1016 of the
sacroiliac joint 1000)
defined between the sacrum 1004 and ilium 1005, the sacroiliac joint 1000
having an
interarticular region 1044. Injection of the radiographic contrast 1046 within
the sacroiliac
joint 1000 can be accomplished utilizing a tubular member 1047)(such as a
syringe
needle) having first tubular member end 1048 which can be advanced between the
articulating surfaces 1016 of the sacroiliac joint 1000 and having a second
tubular
member end 1049 which removably couples to a hub 1050. The hub 1050 can be
configured to removably couple to a syringe barrel 1051 (or other device to
contain and
deliver an amount of radiographic contrast 1046). In the example of a syringe
barrel 1051,
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the syringe barrel 1051 can have an internal volume capable of receiving an
amount of
the radiographic contrast 1046 sufficient for outlining the articular surfaces
1016 of the
sacroiliac joint 1000, for example, under lateral fluoroscopy. A plunger 1052
can be
slidingly received within the barrel 1051 to deliver the radiographic contrast
1046 through
the tubular member 1047 into the sacroiliac joint 1000. The tubular member
1047 can
have a gauge in the range of about 16 gauge and about 20 gauge and can further
be
incrementally marked on the external surface to allow determination of the
depth at which
the first needle end 1048 has advanced within the sacroiliac joint 1000. As
the first needle
end 1048 advances into the sacroiliac joint 1000 the radiographic dye 1046 can
be
delivered from within the syringe barrel 1051 into the sacroiliac joint 1000
to allow
visualization of the sacroiliac joint 1000 and location of the tubular needle
1047 within the
sacroiliac joint 1000.
[00301] Now referring primarily to FIG. 99B, once the first tubular member
end 1048
has been sufficiently advanced into the sacroiliac joint 1000 and the
articular surfaces
1016 of the sacroiliac joint 1000 have been sufficiently visualized, the hub
1050 can be
removed from the tubular member 1047 leaving the tubular member 1047 fixed
within the
sacroiliac joint 1000 as a initial guide for tools subsequently used to locate
or place the
sacroiliac joint implant 25 non- transversely between the articulating
surfaces 1016 of the
sacroiliac joint 1000 (e.g., locate the implant 25 non-transversely to the
joint plane 1030
generally defined by the articulating surfaces 1 01 6 of the interarticular
region 1044 of the
sacroiliac joint 1000) or in removal of a portion of the sacroiliac joint 1000
within the region
defined by the articular surfaces 1016 to generate an implant receiving space
1029 (see
FIG. 99H). Alternately, one or more guide pins 1013 can be inserted along
substantially
the same path of the tubular member 1047 for fixed engagement within the
sacroiliac joint
1000 and used in subsequent steps as a guide(s).
[00302] Now referring primarily to FIG. 990, a small incision 1053 can be
made in
the skin at the posterior superior (or as to certain embodiments inferior)
aspect of the
sacroiliac joint 1000, extending proximal and distal to the tubular member
1047 along the
line of the sacroiliac joint 1000 to provide a passage to access the
interarticular space
between the articulating surfaces 1016 (see FIG. 99B) of the sacroiliac joint
1000. More
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specifically, as can be understood from FIGS. 96A-98B, in one embodiment, the
small
incision 1053 can be made along the joint line 2019 of the sacroiliac joint
1000 in the
tissue covering the posterior inferior access region 2016 of the sacroiliac
joint articular
region 1044. A cannulated probe 1054 can be slidingly engaged with the tubular
member
1047 (or guide pin 1013) extending outwardly from the sacroiliac joint 1000
(while the
sacroiliac joint may be shown in the figures as being substantially linear for
illustrative
purposes, it is to be understood that the normal irregular features of the
sacroiliac joint
have not been removed). The cannulated probe 1054 can have a probe body 1054
of
generally cylindrical shape terminating in a spatulate tip 1055 at the end
advanced into
the sacroiliac joint 1000. A removable cannulated probe handle 1056 couples to
the
opposed end of the probe body 1054. The spatulate tip 1055 can be guided along
the
tubular needle 1047 or guide wire 1013 into the posterior portion of the
sacroiliac joint
1000 and advanced to the anterior portion of the sacroiliac joint 1000 under
lateral
fluoroscopic visualization. The cannulated probe handle 1056 can then be
removed
providing the generally cylindrical probe body 1054 extending outwardly from
the
sacroiliac joint 1000 through the incision 1053 made in the skin.
[00303] Alternatively, probe 1054 can be used to guide, advance or place a
needle,
guide wire or other instrument up to, near, or into the joint.
[00304] Additionally, in particular embodiments, probe handle 1056 or the
opposed
end of the probe body 1054, or both, can be configured to have an interference
fit or a luer
lock hub to communicate with a syringe barrel 1051 in order to advance
contrast, in situ
curable biocompatible materials, stem cells, or etc through the cannulated
probe 1054 or
cannulated probe handle 1056.
[00305] Now referring primarily to FIG. 990, a passage from the incision
1053 (see
FIG. 990) to the sacroiliac joint 1000 can be generated by inserting a cannula
1057 into
the incision. A soft tissue dilator 1058 having a blunt end 1059 can be
advanced over the
probe body 1054, or a plurality of soft tissue dilators of increasing size,
until the blunt end
1059 of the soft tissue dilator 1058 and the corresponding cannula end contact
the
posterior aspect of the sacroiliac joint 1000. More specifically, as can be
understood from
FIGS. 96A-98B, in one embodiment, the ends of the dilator 1058 and cannula
1057
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contact the joint line 2019 of the sacroiliac joint 1000 at the posterior
inferior access
region 2016 of the sacroiliac joint articular region 1044. The soft tissue
dilator 1058 can
be removed from within the cannula 1057. The external surface of the cannula
1057 can
be sufficiently engaged with the surrounding tissue to avoid having the tissue
locate with
in the hollow inside of the cannula 1057. A non-limiting embodiment of the
cannula 1057
provides a tubular body having substantially parallel opposed side walls which
terminate
in a radius at both ends (lozenge shape) into which a plurality of different
jigs can be
inserted. Alternatively, as a non-limiting example, according to particular
embodiments,
cannula 1057 and corresponding dilators 1058 and alignment jigs 1060 can be
configured
to have tubular bodies with an elliptical or circular cross section.
[00306] In some embodiments, the cannula 1057 may be additionally
configured to
have within or near its walls a light source such as, for example, a
fiberoptic or a LED light
source to assist in visualization of the working area. Also, in some
embodiments,
irrigation and suction tubing may communicate with the inside passage of
cannula 1057.
[00307] Now referring primarily to FIGS. 100A-100C, a cannula alignment jig
1060
can be advanced over the probe body 1054 (or guide pins 1013) and received
within the
cannula 1057. Substantially, identical cross hairs 1063, 1064 can be disposed
on the
upper jig surface 1065 and the lower jig surface 1066. Alignment of the cross
hairs 1063,
1064 under x-ray with the sacroiliac joint 1000 can confirm that the cannula
1057 has
proper orientation in relation to the paired articular surfaces 1016 of the
sacroiliac joint
1000. The cannula 1057 properly oriented with the paired articular surfaces
1016 can
then be disposed in fixed relation to the sacroiliac joint by placement of
fasteners through
the cannula 1057 into the sacrum 1004 or the ilium 1005.
[00308] Now referring to FIGS. 101A and 101B, a first drill jig 1067 can be
advanced
over the probe body 1054 (or guide pins 1013) and received within the cannula
1057. The
probe body 1054 (or guide pins 1013) extending outwardly from the sacroiliac
joint 1000
passes through a drill guide hole 1068 of the first drill jig 1067 (or a
plurality of guide pins
1013 can extend through a corresponding plurality of guide pin holes 1069).
The drill
guide hole 1068 can take the form of a circular hole as shown in the Figures,
a slot, or
other configuration to restrict the movement of the drill bit 1062 (see FIG.
99E) within the
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drill jig 1060 and provide a guide for a drill bit 1062 in relation to the
sacroiliac joint 1000.
Guide pin holes 1069 can receive guide pins which can be positioned between
the
articular surfaces 1016 of the sacroiliac joint 1000 to demarcate the zone of
desired
treatment or safe working zones while using, for example, lateral fluoroscopy.
As a
non-limiting example, a first guide pin 1013 can be advanced through a first
guide pin hole
1069, or alternatively a guide pin 1013 is first inserted into the sacroiliac
joint 1000 and
subsequently a guide jig 1067 is advanced over the guide pin 1013, the first
guide pin
1013 can enter near inferior end 2022 of the posterior inferior access region
2016 of the
sacroiliac joint articular region 1044 via the sacroiliac joint line 2019 to
border a portion of
the greater sciatic notch 2008 thereby allowing a medical person, computer
guided
surgical system, or other observer to more easily highlight under x-ray a
border which
should not be crossed during the procedure due to the presence of nerve and
other
structures. Additionally, as a non-limiting example, first guide pin 1013 can
configured as
an electrode, insulated from the operator and the patient's soft tissues, and
may be
connected to a monitor to signal to an operator or surgeon when implant 25,
configured
with a stimulating electrode (NM), as discussed below, comes into contact with
first guide
pin. Similarly, a second guide pin 1013 can be placed in another guide pin
hole 1069 to
demarcate a second limit to a desired zone of treatment, or safe working zone.
For
example, a second guide pin 1013 can enter near the superior end 2018 of the
posterior
inferior access region 2016 of the sacroiliac joint articular region 1044 via
the sacroiliac
joint line 2019 to be positioned to border an area of the sacroiliac joint
1000 such as a
transition zone between the extra-articular 3007(see FIG. 106B) and the
interarticular
region 1044 which, for example, has been highlighted by contrast material as
above
described.
[00309] Now referring to FIG. 99E, a cannulated drill bit 1070 can be
advanced over
the probe body 1054 and within a drill guide hole 1068 (see FIGS. 101A and
101B) of the
first drill jig 1067 . The cannulated drill bit 1070 under fluoroscopic
guidance can be
advanced into the interarticular region 1044 between the articulating surfaces
1016 of the
sacroiliac joint 1000 to produce a first bore 1071 (shown in broken line) to a
determined
depth. As to certain embodiments of the method, an amount of articular
cartilage or other
tissues from between the articular surfaces 1016 of the sacroiliac joint 1000
can be
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removed sufficient to allow embodiments of the sacroiliac joint implant 25 to
be implanted
in replacement of the removed articular cartilage or tissue. Because the
method removes
the degenerative articular cartilage or tissue between the articular surfaces
1016 of the
sacroiliac joint 1000, the articular surfaces 1016 of the sacroiliac joint
1000 can remain
intact or substantially intact allowing the sacroiliac joint implant 25 to be
non-transversely
located between the articular surfaces 1016 of the sacroiliac joint 1000.
Understandably,
other instruments can be utilized separately or in combination with a
cannulated drill bit
1062 for the removal of articular cartilage or tissue between articular
surfaces 1016 such
as: endoscopy tools, box chisels, side cutting router bits, burs, flexible
burs and bits, hole
saws, curettes, lasers (such as CO2, Neodymium/Y AG (yttrium-aluminum-
garnet), argon,
and ruby), electrosurgical equipment employing electromagnetic energy (the
cutting
electrode can be a fine micro-needle, a lancet, a knife, a wire or band loop,
a snare, an
energized scalpel, or the like) where the energy transmitted can be either
monopolar or
bipolar and operate with high frequency currents, for example, in the range of
about
300kHz and about 1000 kHz whether as pure sinusoidal current waveform where
the
"crest factor" can be constant at about 1.4 for every sinus waveform, and a
voltage peak
of approximately 300 V to enable a "pure" cutting effect with the smallest
possible
coagulation effect or as amplitude modulated current waveforms where the crest
factor
varies between 1.5 and 8, with decreasing crest factors providing less of a
coagulation
effect. Electrosurgical waveforms may be set to promote two types of tissue
effects,
namely coagulation (temperature rises within cells, which then dehydrate and
shrink) or
cut (heating of cellular water occurs so rapidly that cells burst). The
proportion of cells
coagulated to those cut can be varied, resulting in a "blended" or "mixed"
effect.
Additionally, a fully rectified current, or a partially rectified current, or
a fulguration current
where a greater amount or lateral heat is produced can be employed to find the
articular
surfaces of the joint and aid in advancing a probe or guide wire into a
position in between
the articulating surfaces. These currents can effectively degrade the
cartilage and allow
advance into the joint without grossly penetrating much beyond the cartilage.
[00310] Now referring to FIG. 99F, as to certain embodiments of the
invention, the
first drill jig 1067 can be removed from within the cannula 1057 and a second
drill jig 1072
can be advanced over the probe body 1054 and received within the cannula 1057;
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however, the invention is not limited to any particular number of drill jigs
and as to certain
embodiments of the method the first drill jig 1067 can include all the
required drill guide
hole(s) 1068 (or slots or other configurations of the drill guide) and as to
other
embodiments of the method a plurality of drill jigs can be utilized in serial
order to provide
all the drill guide holes 1068. As to the particular embodiment of the
invention shown by
the Figures, the first drill jig 1067 can provide one or more additional drill
guide holes 1068
which guide in relation to the first bore 1071 a second or more cannulated
drills 1062 of
the same or different configuration to be inserted within and advanced into
the sacroiliac
joint 1000 to produce a second bore 1073 (generally shown in broken line as
1071/1073)
or a plurality of bores within the sacroiliac joint 1000 spaced apart in
predetermined
pattern to allow removal of sufficient articular cartilage 1016 or other
tissue from the
interarticular space of sacroiliac joint 1000 for placement of embodiments of
the sacroiliac
joint implant 25 within the region defined by and between the paired articular
surfaces
1016 of the sacroiliac joint 1000. As to certain methods of the invention, the
first drill jig
1067 or the second drill jig 1072 or a plurality of drill jigs can be utilized
in serial order to
remove a portion of the sacroiliac joint 1000 for generation of an implant
receiving space
1029 (see, for example, FIG. 99H). As these embodiments of the method,
articular
cartilage or other tissues and sufficient subchondral bone can be removed from
between
the articular surfaces 1016 of the sacroiliac joint 1000 sufficient to allow
placement of
certain embodiments of the sacroiliac joint implant 25 and one or more radial
member
receiving channels 1074 can be cut into at least one of the articular surfaces
1016 of said
sacroiliac joint 1000 sufficient to receive other embodiments of the
sacroiliac implant 25.
The one or more radial member receiving channels 1074 can be cut a depth into
the
subchondral, cortical bone or cancellous bone of the sacrum 1004 or ilium
1005.
[00311] Now referring primarily to FIG. 99G, in a subsequent step, the last
in the
serial presentation of drill jigs 1067, 1072 can be removed from within the
cannula 1057
and a broach jig 1075 can be advanced over the probe body 1054 to locate
within the
cannula 1057. The broach jig 1075 can include a broach guide hole 1076 which
receives
a first broach end 1077 of a cannulated broach 1078 advanced over the probe
body 1054.
The first broach end 1077 can have a configuration which can be advanced into
the
sacroiliac joint 1000. As to certain embodiments of the method, the first
broach end 1077
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can be adapted to remove an amount of articular cartilage and other tissue
from between
the articular surfaces 1016 within the articular region 1044 of the sacroiliac
joint 1000 for
non-transverse placement of a sacroiliac joint implant 25 having an elongate
body 45, or
having an elongate body 45 and a first radial member 50, or an elongate body
45 having
a first and second radial members 50between the articular surfaces 1016 of the
sacroiliac
joint 1000. As to other embodiments of the method, the cannulated broach 1078
can
remove a sufficient portion of the sacroiliac joint 1000 to generate an
implant receiving
space 1029 to receive embodiments of the sacroiliac joint implant 25 having an
elongate
body 45, an elongate body 45 and at least one radial member 50 adapted for
non-transverse placement between the articular surfaces 1016 or at least one
radial
member 55 adapted to extend into the bone of the sacrum 1004 or the ilium
1005.
[00312] As a non-limiting example, FIG. 99G shows a broach 1078 configured
to
remove a portion of the sacroiliac joint 1000 to produce a implant receiving
space 1029
(shown in FIG. 99H) to receive embodiments of the sacroiliac joint implant 25
having an
elongate body 45 to which a first radial member 50 and a second radial member
50
extend along the longitudinal axis CA of the elongate body 45 in substantially
opposed
relation adapted to locate between the articular surfaces 1016 of the
sacroiliac joint 1000
and further having a third radial member 55 and a fourth radial member 55
which extend
along the longitudinal axis CA of the elongate body 45 in substantially
opposed relation
adapted to correspondingly extend correspondingly into the bone of the sacrum
1004 and
the ilium 1 005.
[00313] Now referring primarily to FIGS. 102A-102D, the implant receiving
space
1029 and the sacroiliac joint implant 25 can be configured having related
dimension
relations such that placement of the sacroiliac joint implant 25 within the
implant receiving
space 1 029 disposes the sacrum 1004 and the ilium 1005 in substantially
immobilized
relation and substantially avoids alteration of the positional relation of the
sacrum 1004
and the ilium 1005 from the normal condition, or avoids driving together or
driving apart
the sacrum 1004 from the ilium 1005 outside of or substantially outside of the
normal
positional relation. An intention in selecting configurations of the
sacroiliac joint implant 25
and the implant receiving space 1029 being immobilization of the sacrum 1004
in relation
61
to the ilium 1005 while maintaining the sacroiliac joint 1000 in substantially
normal or
substantially normal positional relation, or returning the sacroiliac joint
1000 to a
substantially normal positional relation to correct a degenerative condition
of the
sacroiliac joint 1000.
[00314] As a non-limiting example, configurations of an implant receiving
space
1029 allow embodiments of the sacroiliac joint implant 25 to be placed non-
transversely
between the caudal portion 1086 of the articular surfaces 1016 of the
sacroiliac joint
1000. While certain embodiments of the sacroiliac joint implant 25 may only
provide an
elongate body 45 which locates within a correspondingly configured implant
receiving
space 1029 to engage at least a portion of the bone of the ilium 1005 or
sacrum 1004,
the invention is not so limited, and can further include at least a first
radial member or a
first and a second radial member at least a portion of the external surface of
the first
radial member 50 engaging a portion of the bone 1073 of the sacrum 1004 and
the ilium
1005. As to those embodiments of the sacroiliac joint implant 25 which have a
third
radial member 55 and a fourth radial member 55, the implant receiving space
1029 can
further include one or more radial member receiving channels 1074, which
correspondingly allow the third and fourth radial members 55, 55 to extend
into the bone
1073 of the sacrum 1004 or the ilium 1005 (whether subchondral, cortical,
cancellous, or
the like), or impact of the sacroiliac joint implant 25 into the implant
receiving space
1029 without the radial member receiving channels 1074 can forcibly urge the
radial
members 55, 55 into the bone 1073 of the sacrum 1004 and the ilium 1005. An
anchor
member 30 (such as treaded members) can be inserted through the bore 40 in the
implant 25 and into the sacrum 1004 and ilium 1005 to fix the location of the
fixation
fusion implant 25 within the implant receiving space 1029.
[00315] While the preceding discussion is given in the context of the
implant 25
being implanted non-transversely in the caudal portion 1086 of the sacroiliac
joint 1000,
in other embodiments, the implant 25 may be implanted in other locations
within the
sacroiliac joint. For example, as disclosed in U.S. Patent Application
12/998,712, in
some embodiments, the implant 25 may be implanted non-transversely in the
cranial
portion 1087 (see FIG. 102A) of the sacroiliac joint 1000 by the similar
procedures or
steps as above described with the incision and
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generation of the passage to the superior articular portion of the sacroiliac
joint 1000. The
implant may also be implanted in the sacroiliac joint in such a manner so as
to extend
between the cranial and caudal portions, as also disclosed in U.S. Patent
Application
12/998,712.
[00316] To begin a discussion of employing the delivery tool 20 to implant
the
implant 25 in the sacroiliac joint 1000 once the implant receiving space 1029
has been
created, reference is made to FIGS. 991, 103A, 103B and 104. FIG. 103A is
generally the
same view as FIG. 97A, and FIG. 103B is an enlarged view of the hip region of
FIG. 103A.
FIG. 104 is generally the same enlarged view as FIG. 96B. As shown in FIGS.
FIGS. 991,
103A, 103B and 104, once the implant receiving space 1029 has been created as
discussed above with respect to FIGS. 99A-99H, the implant 25 can be supported
off of
the distal end 120 of the implant arm 110 of the delivery tool 20 and
positioned such that
the distal end 42 of the implant 25 begins to enter the sacroiliac joint
articular region 1044
via the posterior inferior access region 2016, which is described in detail
above with
respect to FIGS. 96A-98B. As can be understood from FIGS. 103A-104, in
entering the
sacroiliac joint space, the implant 25 is oriented such that its wide planar
members 50 are
oriented generally parallel to, and aligned with, the sacroiliac joint line
2019 (i.e., the wide
planar members 50 are generally located within the joint plane 1030), and the
implant's
narrow planar members 55 are generally transverse to the joint plane 1030
(see, e.g.,
FIGS. 102C and 102D). The longitudinal axis LCA2of the implant arm 110 of the
delivery
tool 20 has a generally anterior trajectory that is located within the joint
plane 1030.
Alternatively, according to particular embodiments, as a non-limiting example,
the
longitudinal axis LCA2 of the implant arm 110 of the delivery tool 20 can have
a trajectory
which can be defined as being generally lateral or, in particular embodiments,
generally
posterior. In some embodiments, when the implant 25 is being delivered into
the joint
space, the implant arm 110 can be said to be at least one of generally
superior or cephald
the sciatic notch.
[00317] FIG. 105 is the same view as FIG. 104, except the implant 25 has
now been
fully inserted into the prepared space 1029 in the sacroiliac joint 1000. As
illustrated in
FIGS. 99J and 105, the implant 25 is fully received in the prepared sacroiliac
space 1029
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such that the wide planar members 50 are oriented generally parallel to, and
aligned with,
the sacroiliac joint line 2019 (i.e., the wide planar members 50 are generally
located within
the joint plane 1030), and the implant's narrow planar members 55 are
generally
transverse to the joint plane 1030 and, in some embodiments, have even entered
the
bone material forming the sacrum and ilium articular surfaces of the
sacroiliac joint (see,
e.g., FIGS. 102C and 1020). As can be understood from FIG. 99J, the
longitudinal axis of
the implant 25 and the longitudinal axis of the implant arm 110 may be
coaxially aligned
with each other and generally located in the sacroiliac joint plane 1030.
[00318] FIG. 106A is the same view as FIG. 104, except the sleeve 100 is
now
received in the collar 165 of the anchor arm 115. As can be understood from
FIGS. 99K
and 106A, the distal end of the sleeve 100 may extend through an incision in
the patient's
soft tissue such that the distal end of the sleeve 100 is positioned generally
against the
lateral surface of the ilium 1005. The longitudinal axis of the sleeve and
collar of the
anchor arm can be understood to be generally coaxially aligned with the
longitudinal axis
of the bore 40 of the implant 25.
[00319] FIG. 106B is generally the same view as FIG. 106A, except the ilium
1005 is
removed to show the sacroiliac joint space boundary 3000 defined along the
sacrum 1004
and outlining the sacroiliac joint articular region 1044, the implant 25
positioned for
implantation within the sacroiliac joint articular region 1044. As shown in
FIG. 106B, the
sacroiliac joint space boundary includes an inferior boundary segment 3002, an
anterior
boundary segment 3004, a superior boundary segment 3006, and a posterior
boundary
segment 3008. The inferior boundary segment 3002 is immediately adjacent, and
extends along, the sciatic notch 2024.
[00320] The inferior boundary segment 3002 and anterior boundary segment
3004
intersect to form an anterior-inferior corner 3010. The anterior boundary
segment 3004
and superior boundary segment 3006 intersect to form an anterior-superior
corner 3012.
The superior boundary segment 3006 and posterior boundary segment 3008
intersect to
form a superior-posterior corner 3014. The posterior boundary segment 3008 and
posterior inferior access region 2016 intersect to form a superior-posterior
corner 3016 of
the posterior inferior access region 2016. The inferior boundary segment 3002
and
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posterior inferior access region 2016 intersect to form an inferior-posterior
corner 3018 of
the posterior inferior access region 2016.
[00321] The inferior boundary segment 3002 extends between corners 3010 and
3018. The anterior boundary segment 3004 extends between corners 3010 and
3012.
The superior boundary segment 3006 extends between corners 3012 and 3014 and
provides an access into the cranial portion 1087 of the sacroiliac joint. The
posterior
boundary segment 3008 extends between corners 3014 and 3016. The posterior
inferior
access region 2016 extends between corners 3016 and 3018 and provides an
access into
the caudal region 1086 of the sacroiliac joint. The posterior boundary segment
3008
separates articular region 1044 and extra-articular region 3007, which
includes the sacral
fossa on the sacrum 1004 and the corresponding iliac tuberosity on the ilium
1005 and
defined by the extra-articular region boundary 3009.
[00322] As shown in FIG. 106B, the implant 25 is inserted via the implant
arm 110 of
the delivery tool 20 into the caudal region 1086 of the sacroiliac joint
articular region 1044.
As shown via the implant 25 and implant arm 110 shown in solid lines, in one
embodiment,
the implant 25 enters the posterior inferior access region 2016, and is
further advanced
into the caudal region 1086 of the sacroiliac joint articular region 1044, in
an orientation
such that the implant arm 110 and wide planar members 50 are in the joint
plane 1030
(see, for example, FIGS. 991-99J) and the longitudinally extending edge 3050
of the wide
planar member 50 next to the inferior boundary segment 3002 is generally
parallel to, and
immediately adjacent to, the inferior boundary segment 3002. Thus, the distal
end 42 of
the implant is heading generally perpendicular to, and towards, the anterior
boundary
segment 3004.
[00323] As shown in FIG. 106B via the implant 25 and implant arm 110 shown
in
dashed lines, in one embodiment, the implant 25 enters the posterior inferior
access
region 2016, and is further advanced into the caudal region 1086 of the
sacroiliac joint
articular region 1044, in an orientation such that the implant arm 110 and
wide planar
members 50 are in the joint plane 1030 (see, for example, FIGS. 991-99J) and
the
longitudinally extending edge 3050 of the wide planar member 50 next to the
inferior
boundary segment 3002 is somewhere between being generally parallel to the
inferior
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boundary segment 3002 (as illustrated by the solid-lined implant 25 in FIG.
106B) or
forming an angle AJ with the inferior boundary segment 3002 of up to
approximately 50
degrees. Thus, the distal end 42 of the implant shown in dashed lines can be
said to head
anywhere from generally perpendicular to, and towards, the anterior boundary
segment
3004 to heading generally towards the superior-anterior corner 3012, or points
in
between.
[00324] In one embodiment, the implant 25 may be first directed into the
joint space
as illustrated by the solid-lined implant 25 in FIG. 106B after which the
implant 25 is
rotated within the joint space to be positioned somewhere between, and
including, angled
position depicted by the dashed-lined implant 25. In other embodiments, the
implant 25
may be first directed into the joint space as illustrated by the dashed-lined
implant 25 in
FIG. 106B after which the implant 25 is rotated within the joint space to be
positioned
somewhere between, and including, the parallel position depicted by the solid-
lined
implant 25.
[00325] FIG. 107A is a posterior-inferior view of the hip region 1002 of
the patient
1001, wherein the soft tissue 1003 surrounding the skeletal hip bones is shown
in dashed
lines. FIG. 107B is an enlarged view of the implant region of FIG. 107A. As
can be
understood from FIGS. 99L, 107A and 107B, the anchor member 30 is positioned
in the
lumen of the sleeve 100. A driving tool 105 (e.g., screw driver) is extended
through the
lumen of the sleeve 100 so the distal end of the tool 105 is engaged with a
proximal end of
the anchor member 30 (e.g., screw). As shown in FIG. 99M, the tool 105 is used
to drive
the anchor member 30 distally through the bone of the ilium 1005 and into the
bore 40 of
the implant 25 generally transverse to the joint line plane 1030. As a result,
as indicated
in FIG. 99N, the implant assembly formed of the implant 25 and anchor member
30 is
secured at the implantation site such that the implant 25 is located in the
prepared space
1029 of the sacroiliac joint space, and the anchor member 30 extends through
the bone of
the ilium 1005 and into the implant bore 40 generally transverse to the joint
space plane
1030. The tool 105 and sleeve 100 can be removed from the anchor arm collar
165, and
the incision associated with the sleeve 100 can be closed. Additionally, tool
105 can be a
cutting tool 105 (e.g., drill bit, hole punch, or etc) which can used in
similar steps as above
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describe to remove bone or other tissues in the path where anchor member 30 is
to be
placed.
[00326] As indicated in FIG. 990, the distal end of the implant arm is
decoupled
from the proximal end of the implant 25 and removed. The incision associated
with the
implant arm can be closed. In some embodiments, the anchor member 30 will only
be
long enough to span bone of the ilium 1005 and enter the implant bore 40. In
other
embodiments, as illustrated in FIG. 99P, the anchor member 30 will be
sufficiently long to
extend through the bone of the ilium, completely through the implant bore 40,
and into the
bone of the sacrum 1004. As illustrated in FIG. 99Q, in certain embodiments,
implant 25
can be configured to have more than one implant bore 40 which can also receive
an
anchor member 30. The anchor member 30 prevents migration of the implant 25
within
the joint space. The anchor member 30 also can draw the ilium and sacrum
together
about the implant 25, increasing the sturdiness of the fixation of the implant
in the joint
space. Where the anchor member extends through the implant bore and into the
bone of
both the sacrum and ilium, the anchor member 30 can be used to drawn the
articular
surfaces 1016 of the sacroiliac joint 1000 against the external surfaces of
the sacroiliac
joint implant 25. With the implant implanted in the sacroiliac joint, the body
will cause the
joint surfaces to fuse together about the implant 25.
[00327] As can be understood from FIGS. 108A and 108B, which are,
respectively,
posterior and posterior-lateral views the implantation area and the implant
assembly
implanted there, proximal end 43 of the implant 25 can be seen positioned in
the posterior
inferior access region 2016, the implant being implanted in the caudal area of
the
sacroiliac joint space. The anchor member 30 can be understood to have been
driven
into the implant bore 40 transversely to the joint plane 1030 via a route in
the ilium 1005
that avoids contact with vascular and neurological structures, thereby
avoiding potentially
life threatening injury to such structures. The ability to blindly, yet
safely, drive the anchor
member 30 into the implant bore 40 while the implant 25 is hidden in the joint
space is
made possible by the cooperating configurations of the implant 25 and the
delivery tool 20.
Specifically, the longitudinal axis LOA, of the anchor arm collar 165 being
coaxially
aligned with the longitudinal axis BA of the implant bore 40 when the proximal
end 43 of
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the implant 25 is supported off of the implant arm 115 of the delivery tool 20
makes it
possible to safely drive the anchor member 30 through the ilium 1005 bone and
into the
implant bore 40 when the implant is hidden in the joint space on account of
being
delivered to the joint space via the delivery tool 20.
[00328] To begin a detailed discussion of another method of employing the
system
to fuse the sacroiliac joint, reference is made to FIGS. 111A-111C. FIG. 111A
is an
inferior-posterior view of the patient's hip skeletal structure similar to the
view depicted in
FIG. 107A. FIG. 111B is a lateral-superior-posterior view of the patient's hip
skeletal
structure. FIG. 111C is an inferior-posterior view of the patient's hip
skeletal structure
taken from a perspective laterally opposite the view depicted in FIG. 111B.
The Si
through S4 foramina can be seen at the respective indicators Si, S2, S3 and S4
in FIGS.
111A-111C.
[00329] As can be understood from a comparison of FIGS. 111A to 107A, the
delivery tool 20 has been reversed such that the anchor collar 165 is oriented
so as to
deliver the anchor member 30 through the sacrum 1004 first and then into the
bore 40 of
the implant 25 and optionally further into the ilium 1005. In other words,
unlike the method
depicted in FIG. 107A, wherein the anchor member 30 is driven lateral to
medial through
the ilium 1005 first and then into the implant followed by the sacrum 1004
(optional), the
method depicted in FIG. 111A shows the anchor member 30 being driven medial to
lateral
through the sacrum 1004 first and then into the implant followed by the ilium
1005
(optional). As can be understood from a comparison of FIGS. 111A to 107A, the
implant
25 of FIG. 111A is located in the sacroiliac joint with its wide radial
members 50, narrow
radial members 55 and body 45 oriented as explained above with respect to
FIGS.
102A-107B, the only difference being the direction the bore 40 is oriented and
the way the
anchor member 30 penetrates the surrounding bone structures.
[00330] In the embodiment of FIG. 111A, the anchor member 30 may be an S2
alar
iliac (52AI) screw. Such a screw may penetrate the sacrum 1004 just lateral
the lateral
edge of the Si foramen and, in some instances, generally superiorly-inferiorly
even with
the superior edge of the Si foramen so as to mimic an S2 alar iliac pelvic
fixation.
Alternatively, according to particular embodiments, for example, as shown in
FIG. 111A,
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such a screw may penetrate the sacrum 1004 just lateral the lateral edge of
the S2
foramen and, in some instances, generally superiorly-inferiorly even with the
superior
edge of the S2 foramen.
[00331] To begin a detailed discussion of another method of employing the
system
to fuse the sacroiliac joint, reference is made to FIGS. 112A-112D. FIG. 112A
is an
inferior-posterior view of the patient's hip skeletal structure similar to the
view depicted in
FIG. 107A. FIG. 112B is a side view of the patient's hip skeletal structure
similar to the
view depicted in FIG. 106A. FIG. 112C is a view of the patient's hip skeletal
structure
similar to the view depicted in FIG. 103A, except from an opposite lateral
perspective.
FIG. 112D is a superior view of the patient's hip skeletal structure.
[00332] As can be understood from a comparison of FIGS. 112A and 112B to
FIGS.
107A and 106A, respectively, in the embodiment depicted in FIGS. 112A-1120,
the
delivery tool 20 has a trajectory that is generally superior-to-inferior as
opposed to
posterior-to-anterior. Further, unlike the embodiments described above wherein
the
implant 25 gains access to the sacroiliac joint space 1044 via the caudal
access 2016 to
be implanted in the caudal region 1086 of the sacroiliac joint space 1044
(see, for
example, FIG. 106B and related figures and discussion), the embodiment of
FIGS.
112A-1120 gains access to gains access to the sacroiliac joint space 1044 via
the cranial
access 2017 (e.g., at the superior boarder 3006 shown in FIG. 106B) to be
implanted in
the cranial region 1087 of the sacroiliac joint space 1044 (see, for example,
FIG.
112C-1120).
[00333] As indicated in FIGS. 112A-112D, the delivery tool 20 is oriented
such that
the anchor collar 165 is positioned so as to deliver the anchor member 30
through the
ilium 1005 first and then into the bore 40 of the implant 25 and optionally
further into the
sacrum 1004. In other words, the method depicted in FIGS. 112A-112D shows the
anchor member 30 being driven lateral to medial through the ilium 1005 first
and then into
the implant followed by the sacrum 1004 (optional). Other than being delivered
via a
different trajectory and access location and being implanted in a different
region of the
sacroiliac joint, the implant 25 of FIGS. 112C-1120 is located in the
sacroiliac joint with its
wide radial members 50, narrow radial members 55 and body 45 oriented as
explained
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above with respect to FIGS. 102A-102D, the only difference being the implant
25 being
accessed via, and implanted in, the cranial region 1087 as opposed to the
caudal region
1086.
[00334] To begin a detailed discussion of another method of employing the
system
to fuse the sacroiliac joint, reference is made to FIGS. 117A-117C. FIG. 117A
is a
lateral-inferior-posterior view of the patient's hip skeletal structure
similar to the view
depicted in FIG. 111C. FIG. 117B is an inferior-posterior view of the
patient's hip skeletal
structure similar to the view depicted in FIG. 111A. FIG. 117C is the same
view as FIG.
106B, except showing the implant 25 being implanted in the extra-articular
space 3007,
as opposed to the sacroiliac joint articular region 1044, and accessing the
extra-articular
space 3007 via an extra-articular recess access region 6000. The 51 through S4
foramina can be seen at the respective indicators 51, S2, S3 and S4 in FIGS.
117A-117B.
[00335] As can be understood from a comparison of FIGS. 117A to 107A, the
delivery tool 20 has been reversed such that the anchor collar 165 is oriented
so as to
deliver the anchor member 30 through the sacrum 1004 first and then into the
bore 40 of
the implant 25 and optionally further into the ilium 1005. In other words,
unlike the method
depicted in FIG. 107A, wherein the anchor member 30 is driven lateral to
medial through
the ilium 1005 first and then into the implant followed by the sacrum 1004
(optional), the
method depicted in FIG. 117A shows the anchor member 30 being driven medial to
lateral
through the sacrum 1004 first and then into the implant followed by the ilium
1005
(optional). In the embodiment of FIG. 117A, the anchor member 30 may be a bone
screw
the same as or similar to an S2 alar iliac (S2AI) screw. Such a screw may
penetrate the
sacrum 1004 just lateral the lateral edge of the Si foramen and just superior
the superior
edge of the Si foramen. Thus, the anchor element 30 can enter the bone of
sacrum near
the first sacral foramen (S2A I trajectory) then into or through implant bore
40 and can
further enter the bone of the ilium. The implant 25, as with any of the
implantation
locations and implants 25 discussed herein can optionally be employed to be
configured
to serve as an attachment point for structural components of a spinal support
system with
a spanning element as discussed below with respect to FIGS. 115 and 116 or
with a
coupling element as discussed below with respect to FIG 114.
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[00336] As can be understood from a comparison of FIGS. 117A to 107A, FIGS.
117B to 1110, and FIGS. 1170 to 106B, the implant 25 of FIG. 1170 is located
in the
extra-articular region 3007 as opposed to the sacroiliac joint articular
region 1044.
Further, the implant 25 of FIGS. 117A-C has entered the extra-articular region
3007 via
an extra-articular recess access region 6000, which, is on the opposite side
of the
posterior inferior overhang 2020 of the posterior superior iliac spine 2004
from the caudal
portion 1086 of the sacroiliac joint articular region 1014 and posterior
inferior access
region 2016 leading to the sacroiliac joint articular region 1044 employed to
implant the
implant 25 in the caudal portion 1086 of the sacroiliac joint articular region
1044, as
discussed above with respect to FIGS. 103A-108B or FIGS. 111A-111C.
[00337] As can be understood from FIG. 1170, the implant 25 is oriented in
the
extra-articular region 3007 with its wide radial members 50 generally coplanar
with the
plane of the extra-articular region 3007 and the narrow radial members 55
extending into
the sacrum and ilium bone defining each side of the extra-articular region
3007.
[00338] As illustrated in FIG. 1170, in some embodiments, the implant 25 is
oriented within the extra-articular region 3007 such that the longitudinal
axis of the body
45 is generally perpendicular to the posterior boundary segment 3008 of the
boundary
3000 of the sacroiliac joint articular region 1014. Also, the distal end 42 of
the implant 25,
when implanted in the extra-articular region 3007, points towards the anterior-
inferior
corner 3010 of the boundary 3000 of the sacroiliac joint articular region
1014. The distal
end 42 of the implant 25 may extend across the posterior boundary segment 3008
of the
boundary 3000 of the sacroiliac joint articular region 1014 and into the
sacroiliac joint
articular region 1014. Thus, when implanting the implant 25 via the extra-
articular recess
access region 6000, the general direction of travel for the implant distal end
42 is towards
the anterior-inferior corner 3010, and the implant 25 can be positioned
substantially within
the extra-articular region 3007 or, alternatively, the implant 25 can be
further advanced to
also occupy a portion of the sacroiliac joint articular region 1044.
[00339] As discussed above with respect to FIGS. 117A-117B, in implanting
the
implant 25 in the extra-articular region 3007, the delivery tool 20 is
configured to drive the
anchor element 30 medial to lateral through the sacrum 1004 into the implant
bore 40 and,
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optionally, further into the ilium 1005. However, in some embodiments, the
delivery tool
20 and implant bore 40 may have as-manufactured configurations that allow the
anchor
element 30 to be driven lateral to medial through the ilium 1005 into the
implant bore 40
and, optionally, further into the sacrum 1004.
[00340] In some embodiments, the system 10 may be provided in the form of a
kit
4999. Such a kit 4999 is shown in FIG. 113. The kit 4999 may include the
system 10
enclosed in a sterile main package 5000. For example, the delivery tool 20,
the implant
25 and anchor member 30 may be sealed within the sterile main package 5000.
The
delivery tool 20 may be any of the tool embodiments disclosed herein and may
include all
of its components. Also, the implant 25 may be any of the implant embodiments
disclosed herein.
[00341] As illustrated in FIG. 113, in some embodiments, the kit 4999 may
include
multiple sizes of the implant 25 and/or multiple sizes of the anchor member
30. The
multiple implants 25 may be contained in a sterile individual package 5002
within the
sterile main package 5000, and the multiple anchor members 30 may be contained
in
another sterile individual package 5004 within the sterile main package 5000.
By
providing the multiple sizes of implants 25 and anchor members 30, the
implants and
anchor members can be used as trials during certain steps of the procedure to
determine
appropriate implant sizes and to allow a physician, who is presented with the
kit 4999
containing the delivery system 20 and multiple sizes of the implant and anchor
members,
to evaluate particular embodiments of an implant and anchor member as
described
herein that would be best suited to a particular patient, application or
implant receiving
space. The kit 4999 may also or alternatively contain multiple implants 25
with different
angles of bore 40 to provide various desirable trajectories for an anchor
member 30 and
multiple delivery systems 20 with as-manufactured angular relations
corresponding to the
different angles of the bore. The kit 4999 may also include color coded,
numeric or other
indicators corresponding between delivery systems 20 and the corresponding
implants
25.
[00342] In some embodiments, the kit 4999 may include instructions 5006
that lay
out the steps of using the system 10. The instructions 5006 may be contained
within one
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of the sterile packages such as, for example, the sterile main package 5000.
Alternatively,
the instructions 5006 may be adhered or otherwise attached to an exterior
surface of one
of the sterile packages such as, for example, the sterile main package 5000.
Alternatively,
the instructions 5006 may be simply provided separately such as, for example,
via simply
shipped loose with the rest of the kit 4999, emailed, available for download
at a
manufacturer website, or provided via a manufacture offered training seminar
program.
[00343] In some embodiments, the kit 4999 may have any one or more of the
tool 20,
implants 25 and anchor members 30 contained in individual sterile packages
that are not
held within a sterile main package. Alternatively, the tool 20, implants 25
and anchor
members 30 may be contained in a single common package or in any combination
of
packages and combination of tool, implants and anchor members.
[00344] As can be understood from FIG. 114, which is the same transverse
cross
sectional view of the patient's hip as shown in FIGS. 99A-99Q, once the
implant 25 and
anchor(s) 30 are secured at the sacroiliac joint 1000 in any of the manners
depicted in
FIGS. 990 ¨ 99Q, the implant 25 can be used as an attachment point for
structural
components of a spinal support system configured to support across the
patient's hip
structure and/or to support along the patient's spinal column. To serve as an
attachment
point for structural components of a spinal support system, a coupling element
2087 is
connected to the proximal end 2011 of the sacroiliac joint implant 25. As a
non-limiting
example, the coupling element 2087 can be disposed in fixed relation to the
proximal end
2011 of the sacroiliac joint implant 25 by threaded engagement of a fastener
portion 2088;
however, the invention is not so limited and the fastener portion 2088 can be
connected to
the first end 2011 of the sacroiliac joint implant 25 by any method such as
welding, spin
welding, adhesive, or the like. The coupling element 2087 can further provide
a coupling
portion 2089 configured to join with a numerous and wide variety of cross
sectional
geometries of spanning members 2090. As a non-limiting example, the coupling
portion
2089 can be configured as cylindrical cup 2091 pivotally coupled to the
fastener portion
2088. A spiral thread can be coupled to the internal surface of the
cylindrical cup 2091 to
rotationally receive a spirally threaded body 2092. The side wall 2093 of the
cylindrical
cup 2091 can include a pass through element 2094 in which part of a spanning
member
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2090 can be received. The part of the spanning member 2090 received within the
pass
through element 2094 can be placed in fixed relation to the cylindrical cup
2091 by
rotational engagement of the spirally threaded body 2092.
[00345] FIG. 115 is a posterior view of the patient's sacrum 1004 and
illiums 1005,
wherein structural components of a spinal support system extend medial-lateral
across
the patient's hip structure and superiorly to support along the patient's
spinal column. As
shown in FIG. 115, in one embodiment, each of a pair of sacroiliac joints 1000
can receive
an embodiment of the sacroiliac joint implants 25, above- described, each
having a
coupling element 2087 coupled to the first end 2011. Each of the coupling
elements 2087
can receive the opposed ends 2095 of a spanning member 2090. Additionally, the
spanning member 2090 in fixed relation to the sacroiliac joint implants 25 can
be
connected to a plurality of additional spanning members 2096 which can as a
non- limiting
example be placed in positional relation to the vertebral column 2097 to allow
support of
additional implants which can be anchored between vertebrae.
[00346] FIG. 116 is the same view as FIG. 117, except having a different
spanning
member structure. As illustrated in FIG. 116, a first coupling element 2087
can be joined
to the first end 2011 of an embodiment of a sacroiliac joint implant 25 as
above described
and the fastener portion 2088 of a second coupling element 2087 can be
disposed
directly into the bone of the sacrum 1004 or the ilium 1 005, or both. The
opposed ends
2095 of a spanning element 2090 in the form of a flat plate can be can provide
apertures
2096 through which the fastener portion 2088 of the coupling element 2087 can
pass. The
corresponding parts of the external surface of the coupling portion 2089 and
the spanning
member 2090 can be engaged to fix the location of the spanning member 2090
allowing
for coupling of the lumbar spine to the stabilized pelvis by a plurality of
fixation elements to
further increase stability. As an example, fastener 2088 can be a pedicle
screw and may
be implanted in the Si pedicle and angled generally anteriorly and generally
parallel to
the Si endplate. Additionally, spanning element 2090 can be coupled to an
implant 25
similar to FIGS. 41-54, or configured similarly but with the spanning element
coupled to
one of the planar members (e.g., planar member 50 and with spanning element
extending
radially away from the longitudinal axis of an implant 25 and at least
partially existing in
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the plane of a sacroiliac joint before contouring to the posterior surface of
a sacrum and
terminating at an opposed end 2095.)
[00347] As can be understood from FIG. 116 and with continuing reference to
FIGS.
111A-C and 117A-C, according to particular embodiments, the spanning element
2090
can be configured to receive an S2AI screw positioned and directed in a
trajectory as
substantially shown in FIGS. 111A-C or 117A-C. As a non-limiting example, an
S2AI
screw or other elongate fixation body can pass through an aperture 2096, which
can be
located on an opposed end 2095 of the spanning element 2090 and can be
disposed
directly into the bone of the sacrum 1004, pass through or engage the bore 40
of an
implant 25, and into the bone of the ilium 1005. According to certain
embodiments, an
engagement between an S2AI screw and the bore 40 can be configured, for
example, as
having a bore 40 which can have threads or other surface that are generally
complementary to those of a fastener 2088. Said complementary surfaces can be
configured to provide a virtual cold weld between components to further resist
undesirable movement.
[00348] As shown in FIGS. 119A-119E, which are, respectively, distal end
isometric,
side elevation, plan, distal end elevation, and proximal end elevation views
of another
embodiment of an implant 25, the features of the implant 25 of FIGS. 119A-119E
are
substantially similar to the features of the implant 25 as described herein,
for example
with respect to FIGS. 4-17. The main differences between the implant 25
described with
respect to FIGS. 119A-119E and the implant 25 described with respect to FIGS.
4-17 are
the lack of the cylindrical body 45 and the edges of adjacent intersecting
surfaces of the
implant 25 of FIGS. 119A-119E are generally rounded or arcuate as opposed to
sharp or
well-defined edges, as is the case between adjacent intersecting surfaces of
the implant
embodiment of FIGS. 4-17. Further, the planar members 50 may taper distally
and be
relatively thicker as compared to the planar members 55 of the implant
embodiment of
FIGS. 119A-119E. For example, the taper may extend the entire length of the
implant 25
with the thickness of planar member 50 near implant distal end 42 being about
3-5mm
and the thickness of the planar member 50 near the implant proximal end 43
being about
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6-7mm. Finally, the leading or distal edges 57 of the planar members 50 may be
one or
more tapered surfaces, as shown in FIGS. 119A-119E.
[00349] FIGS. 120A-120B are, respectively, distal end isometric and side
elevation
views of yet another embodiment of the implant 25. As can be understood from
FIGS.
120A-120B, the features of the implant 25 are substantially similar to the
features of the
implant 25 described with respect to FIGS. 119A-119E, a main difference being
that the
leading or distal edges 57 of the planar members 55 are generally sharp, well-
defined
angled edges, as opposed to the generally rounded or arcuate edges of the
implant
embodiment of FIGS. 119A-119E.
[00350] In one embodiment, as can be understood from the dashed lines in
FIG.
120B, the planar members 50 may be non linear between distal end 42b and
proximal
end 43 such that there is a radius R between implant ends (or between distal
end 42b and
a point, for example, midway along the longitudinal axis). The radius Rmay be
about 100
mm to about 200 mm with one embodiment being approximately 150 mm.
Accordingly,
as indicated by the dashed lines in FIG 120B, planar members 50b may terminate
with a
distal end 42b. Additionally, but not shown in the figures, planar members 55
may be
similarly curved so as to substantially follow along or be aligned with curved
planar
members 50b. Such a configuration may more anatomically conform to the
curvature of a
sacroiliac joint while allowing planar members 50b to generally remain within
a curved
plane of a sacroiliac joint.
[00351] As shown in FIGS. 121A-121E, which are, respectively, distal end
isometric,
side elevation, plan, distal end elevation, proximal end elevation, proximal
end isometric,
and side elevation views of another embodiment of an implant 25, the planar
members 50,
55 may have surface features or texture designed to prevent migration of the
implant
once implanted in the joint space. For example, the implant 25 may include
anti-migration
surface features 355, which are waved, undulating, or spiral ridges extending
longitudinally along the planar members 50, 55. Alternatively, anti-migration
surface
features 355 may be configured to extend perpendicular to the longitudinal
axis of planar
members 50, 55.
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[00352] It will be appreciated that the features of the implant 25 of FIGS.
121A-121G
are substantially as discussed herein, for example, with respect to the
implant 25 of FIGS.
62-67, a main difference being the implant 25 is hollow and the surfaces 60
include a
plurality of voids 6500, which are generally triangular in shape. The voids
6500 of the
implant 25 may be filled with a biological material (e.g., a protein,
demineralized bone
matrix, or lattice structure containing or substantially comprised of stem
cells) via an
access opening 6502 leading to the hollow interior of the implant. The
biological material
is designed to improve growth of bone around the implant 25 and to strength
the
integration of the implant 25 to the bone. The voids 6500 improve integration
of the
implant 25 to the bone. Further, the leading or distal edges 57 of the planar
members 50
and the implant distal end 42 of FIGS. 121A-121G may be relatively thicker as
compared
to the implant embodiment of FIGS. 62-67. Additionally, as can be best
understood from
FIG. 121C, the leading or distal edges 57 of the planar members 50 may differ
in length
and general shape. For example, as can be understood from FIGS. 121B-121C, a
first
leading or distal edge 57 may be generally round and arcuate and relatively
longer as
compared to a second leading or distal edge 57 that is generally flat and
relatively shorter.
Further, as shown in FIGS. 121D, 121F and 121G, the planar member 50 may
include an
access opening 6502 leading to the hollow interior of the implant.
[00353] With an opening 6502 on one side of the implant and not on the
opposite
side of the implant, the implant is configured to allow and promote boney
growth, or
expansion of biological material inserted within, toward, for example, certain
areas within
the sacroiliac joint and away or not toward certain other areas of the
sacroiliac joint when
the implant is implanted in the sacroiliac joint. For example, when the
implant 25 of FIGS.
121A-121G is inserted into the sacroiliac joint similar to the manner
indicated in FIG.
106B, wherein the opening 6502 of the implant 25 is oriented towards the
posterior
boundary segment 3008, boney growth or the expansion of biological material
contained
in the implant will extend through the implant opening 6502 in the direction
of the posterior
boundary segment 3008 and be specifically directed away from inferior boundary
3002,
anterior-inferior boundary 3010 and anterior boundary segment 3004 to limit
potential
bone growth, or seepage of biologically active agents near the neurovascular
structures
which are present beyond said boundaries.
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[00354] Additionally, as can be best understood from FIGS. 121A and 1210,
and
with continuing reference to FIGS. 106B and 117C, as indicated by arrow F in
FIGS. 121A
and 1210, one of the leading distal edges 57 (e.g., the edge located opposite
the side
with opening 6502) of the planar member 50 of the implant may be curved and of
a
substantially greater radius as compared to the distal edge 57 of the opposite
planar
member 50. Such a curved section (indicated by arrow F) on the distal edge 57
of planar
member 50 may be configured to anatomically generally mimic and even
substantially
conform to a anterior-inferior corner 3010 (see, e.g., FIGS. 117C and 106B) in
order to
more fully occupy this region of the joint nearest neurological and vascular
structures
which are present anterior to and inferior to corner 3010.
[00355] The curved section (indicated by arrow F) (or according to
particular
embodiments located anywhere in implant 25) can additionally be configured to
include
an inlayed radiopaque marker, for example tantalum, to assist the surgeon with
navigation while using fluoroscopy. Further, according to particular
embodiments, the
curved section (arrow F) can be configured to include a stimulating electrode
(NM)
connected to an internal controllable power source or external controllable
power source.
For example, the external controllable power sources may be either in the
delivery system
instrumentation 20 itself or a separate controller unit located in the
operating suite and
electrically coupled to the implant supported electrode NM via electrical
conductors
extending through the implant body and the implant arm 110 of the delivery
system 20 to
electrically couple to the separate controller unit via a cable extending
proximally from the
delivery system 20 to the separate controller. With the exception of the
electrode (NM)
itself, the entirety of the rest of the implant surfaces may be electrically
insulated so as to
prevent current shunting into surrounding tissues or the operator.
[00356] In one embodiment, the stimulating electrode (NM) during navigation
can
have an amperage of about 8 milliampers (mA) or, nearing final placement, an
amperage
of about 1-4 mA and, in certain cases, up to 5 mA. The electrode (NM) may be
attached
to or at least partially imbedded in implant 25 (either permenantly or
retrievable/removable after implantation) (or according to particular
embodiments,
located within, near or on the anchor 30, probe 1054, on or within a trial,
broach, drill or
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other tools of system 10) to reduce the risk to the patient of iatrogenic
damage to the
nervous system by using intraoperative neurophysiological monitoring, for
example
electromyography (EMG), which is able to alert the surgeon or technician
reliably and in
real-time of implant 25 advancing beyond, for example, inferior boundary
segment 3002
or beyond anterior-inferior corner 3010.
[00357] As illustrated in FIG. 121H, which is a schematic depiction of a
joint
implantation system 10 configured for nerve stimulating and sensing, in one
embodiment,
the system 10 includes a joint implant 25, a delivery tool 20, a nerve
stimulating system
10003, a pre-amplifier unit 10004, an amplifier unit 10005, a computer 10006,
and an
electrical conductor pathway 10001. The joint implant 25 includes an electrode
NM and a
body 45 including a distal end 42 and a proximal end 43 opposite the distal
end. The
electrode NM is supported on the implant 25. The delivery tool 20 includes an
implant
arm 110 with a distal end 35 configured to releasably couple to the proximal
end 43 of the
body 45 of the joint implant 25. The nerve stimulating system 10003 is
configured to
stimulate electrode NM in order to sense nerve contact made with the electrode
NM or
when NM is approaching and near a nerve. The electrical conductor pathway
10001
extends from the electrode NM along the implant 25 and implant arm 110 to the
nerve
stimulating system 10003. The electrical conductor pathway 10001 places the
electrode
NM and nerve stimulating system 10003 in electrical communication.
[00358] A sensing (or recording) electrode 10011 can be placed in, for
example, a
quadriceps femoris, tibialis anterior, gastrocnemius, or abductor hallucis
muscle and may
be coupled to an electrical conductor pathway 10007 that extends to the pre-
amplifier
10004. A reference electrode 10010 can also be placed in, for example, a
quadriceps
femoris, tibialis anterior, gastrocnemius, or abductor hallucis muscle, but in
a location
between the area subject to stimulation from the stimulating electrode (NM)
and the
sensing (or recording) electrode 10011; and may be coupled to an electrical
conductor
pathway 10012 that extends to the nerve stimulating system 10003. An
additional needle
10009 can be placed in proximity to the aforementioned needles (i.e.,
electrodes 10010,
10011) within a muscle (or when the electrode is in the form of a patch it may
be applied to
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the skin of the patient) and may be coupled to an electrical conductor pathway
10008 that
extends to the pre-amplifier 10004 and a ground.
[00359] The pre-amplifier 10004 may be connected to the amplifier 10005
that itself
may be connected to the computer unit 10006. The computer unit 10006 may
process or
interpret the signal from the amplifier 10005 and display or otherwise alert
(e.g., auditory
signals with varying amplitude or frequency) or convey to an observer or
operator in an
operating suite or to a monitoring physician in a remote location (e.g., by
employing
computer software and processing and networking hardware) the state of the
various
electrical connections and pathways (e.g., connected versus disconnected) and
electrical
activity caused by the stimulating electrode NM.
[00360] In one embodiment, the proximal end 43 of the implant 25 and the
distal end
35 of the implant arm include a cooperatively mating electrical connection
10000 that form
a segment of the electrical conductor pathway 10001. An example of such a
cooperatively mating electrical connection includes a male-female pin contact
assembly
10000. The proximal end 80 of the delivery tool 20 and a distal end of an
electrical
conductor segment of the pathway 10001 between the sensing system 10003 and
the
proximal end 80 include a cooperatively mating electrical connection 10002
that form a
segment of the electrical conductor pathway 10001. The electrical conductor
pathway
10001 may be in the form of one or more multi-filar cables, one or more solid
core wires,
etc. The electrode NM is at or near the distal end 42 of the implant 25 and
the rest of the
implant (or only an area directly surrounding the electrode NM) has an
electrically
insulative coating or is formed of an electrically nonconductive material.
[00361] As can be understood from FIGS. 121A-121G, in one embodiment, the
joint
implant 25 includes a longitudinal axis and a bore 40 extending non-parallel
to the
longitudinal axis. The joint implant 25 also includes a hollow interior and an
exterior
surface having a plurality of openings 6500 defined therein that extend into
the hollow
interior. Prior to implantation of the implant into the joint space, the
hollow interior can be
filled with a biological material via the access opening 6502 that leads into
the hollow
interior of the implant.
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[00362] The implant of FIGS. 121A-121G also includes a distal end 42, a
proximal
end 43, and a body extending between the proximal and distal ends. The bore 40
extends non-parallel to the hollow interior. A first pair of planar members 50
radially
extend from the body of the joint implant 25. Depending on the embodiment, the
body
may be similar to the body 45 depicted in FIGS. 5-15 or the body may simply be
an
intersecting or intermediate region of the first pair of planar members 50, as
can be
understood from FIGS. 121A-121G.
[00363] As shown in FIGS. 121A-121G, the hollow interior extends within the
confines of the first pair of planar members 50. Also, the exterior surface in
which the
plurality of openings 6500 is defined includes exterior planar surfaces 60 of
the first pair of
planar members 50. A second pair of planar members 55 radially extend from the
body of
the joint implant 25 generally perpendicular to the first pair of planar
members 50. As can
be understood from FIG. 121F, in some embodiments, the hollow interior is
limited to
within the confines of the first pair of planar members 50 while the second
pair of planar
members 55 are solid such that the hollow interior does not enter the confines
of the
second pair of planar members. In other embodiments, the hollow interior is
limited to the
confines of the second pair of planar members or the hollow interior may
extend into the
confines of both pairs of planar members. As indicated in FIG. 121E, in one
embodiment,
the first pair of planar members 50 extend over a wider radial extent than the
second pair
of planar members 55.
[00364] FIG. 122 is a proximal end isometric view of another embodiment of
the
implant assembly 15. As can be understood from FIG. 122, the features of the
implant
assembly 15 are substantially the features described herein, for example, with
respect to
FIG. 3, a main difference being that a distal end 6510 of the anchor element
30 includes
an opening 6506 and edges 6508 in the form of serrated teeth or notches with
parallel
sides inwardly terminating as an arcuate end. The opening 6508 creates a
generally
"clothes-pin" like shape of the anchor element distal end 6510. In one
embodiment, the
edges 6508 may be triangular, trapezoidal, rectangular, or another angular
cross-sectional elevation and generally evenly distributed along the surface
of the anchor
element distal end 6510. The edges 6508 help drive the implant assembly 15
into the
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joint and prevent migration of the implant assembly 15 once in place.
[00365] In one embodiment, opening 6506 is defined by arms 6507. The
opening
6506 and arms 6507 are configured such that, after passing through a channel
created in
a first bone and after passing through bore 40 and then subjected to impaction
into a
second bone, for example that of the ilium, bone of the second bone can be
received into
opening 6506 to urge the "clothes pin" arms 6507 apart from one another
thereby further
embedding the edges 6508 into bone for enhanced fixation. Alternatively, in
other
embodiments, anchor 30 may be configured in part or completely of shape memory
biomaterials (e.g., Nitinol or PEEK ALTERA (available from MedShape, Inc.
located at
1575 Northside Drive, NW, Suite 440, Atlanta, GA 30318 USA), which are capable
of
changing shape in response to temperature, light and/or mechanical forces). An
anchor
30 configured with a shape memory biomaterial can be configured, for example,
immediately prior to insertion as substantially shown in FIG. 122 with
"clothes-pins" arms
6507 in general parallel relation. Upon final placement in the ilium or other
second bone,
the "clothes-pins" arms 6507 (in response to temperature, light and/or
mechanical force)
can separate away from one another and in certain embodiments "curl" outwardly
and
back toward the proximal end of anchor 30 in order to further resist
undesirable
movement of implant assembly 15. Another main difference between the implant
assembly embodiment of FIG. 122 and of FIG. 3 is that a washer 6504 is coupled
to the
anchor element 30. The washer 6504 and the shape and texture of the anchor
member
distal end 6510 secure the implant assembly 15 in the sacroiliac joint. The
washer can be
(pivotably) coupled to the anchor such that when inserted or explanted the
washer
remains coupled to the anchor and need not be removed separately.
[00366] FIGS. 123A-123E are, respectively, distal end isometric, side
elevation,
plan, distal end elevation, and proximal end elevation views of yet another
embodiment of
the implant 25. As can be understood from FIGS. 123A-123E, many of the
features of the
implant 25 are substantially the features of the implant 25 described herein,
for example,
with respect to FIGS. 119A-119E, a main difference being that the planar
members 50, 55
are generally round or arcuate and the implant distal end 42 is generally
rounded.
Specifically, the leading or distal edges 57 of the implant embodiment of
FIGS.
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119A-119E are not separate features in the embodiment of FIGS. 123A-123E and
instead
are generally incorporated in the rounded or arcuate surfaces of the planar
members
50,55, which intersect at the implant distal tip 42. Additionally, the implant
proximal end
43 is generally flat with round edges, and relatively wider than the implant
embodiment of
FIGS. 119A-119E. The planar members 50 may each include a channel 6514
extending
longitudinally and opening into the implant proximal end 43 adapted for
receiving a distal
end of the delivery device as described herein.
[00367] Further, another main difference is that the implant 25 shown in
FIGS.
123A-123E includes wings 6516, which are separated from the planar members 50,
55 by
a gap 6512. In other words, the gap 6512 extends longitudinally between the
planar
members 55 and the wings 6516 until the implant proximal end 43. The wings
6516 allow
the implant 25 to be driven into the joint region with the wings existing in a
plane
transverse to the joint plane such that one of the wings 6516 is delivered
into the sacrum
and the other wing 6516 into the illium. The wings 6516 may include anti-
migration
surface features 355 in the form of notches or ribs extending inwardly in the
gaps 6512
that are generally evenly distributed longitudinally along the wings 6516
parallel to the
planar members 55 and oriented transversely to the longitudinal axis of the
respective
wing. The anti-migration surface features 355 and the wings 6516 prevent
migration of
the implant 25 once placed, as described herein. As can be understood from
FIGS.
124E-124H, the implant of FIGS. 123A-123E may additionally includes a bore 40
extending through the implant 25 to receive an anchor 30 delivered via an
anchor arm 115
of the system 10 as described herein. Such a bore 40 may extend through the
implant so
as to extend in generally the same plane in which the wings 6516 exist.
[00368] In some embodiments, for example, the relative location and angles
between wings 6516 and planar members 50,55 can remain substantially the same
before and after implantation. Alternatively, in some embodiments, the wings
6516 can
be configured to deflect a distance away from planar members 50, 55 upon
insertion and
contact with bone. In other words, the gaps 6512 may enlarge upon placement
and, to
facilitate such enlargement of the gaps 6512, anti-migration features 355, or
distal ends
6516A of wings 6516, may be configured with a sloping surface to urge wings
6516 a
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distance away from planar members 50, 55. Upon final placement, the deflected
wings
6516 urge bone or joint surfaces against the implant 25 in order to enhance
bone contact
with the implant 25 by compression to enhance bone fusion and to enhance
fixation of the
bones or bone fragments by potential energy stored in the deflected wings
6516.
Alternatively, according to particular embodiments, the implant 25, or only
the wings 6516,
may be manufactured from a shape memory biomaterial. In such embodiments, the
position of the wings 6516 before implantation may be such that their distal
ends 6516A
are a further distance from planar members 50, 55 than shown in FIG. 123A-E.
After final
placement of the implant in the sacroiliac joint, an angleia) of the gap 6512
can decrease
and the distance between distal ends 6516A of wings 6516 and planar members
50, 55
can decrease by the shape memory biomaterial biasing or shaping to appear
substantially as shown in FIGS. 123A-E. As a result, the wings 6516 provide
compression of the bone in gap 6512 against the surfaces of the implant 25.
[00369] Alternatively, proximal ends 6516B of wings 6516 can be configured
with a
hinge between the proximal ends 6516B and the proximal end 43 of implant 25 to
allow
wings 6516 to deflect away from planar members 50, 55 upon implantation.
Additionally,
the proximal ends 6516B can extend a distance proximally further than the
proximal end
43 of implant 25. Also, an end cap can be secured to the proximal end 43 of
implant 25.
Advancing the end cap distally can bias the extended proximal ends 6516B away
from the
longitudinal axis of implant 25 by causing rotation of the wings about the
hinges. Such
rotation causes the portion of the wings 6516 distal said hinges to rotate an
opposite
complementary angular distance toward the longitudinal axis of the implant 25,
resulting
in compression of bone against implant 25 for enhanced fusion and fixation.
[00370] Alternatively, proximal ends 6516B of wings 6516 may be attached to
proximal end 43 of implant 25 by slidable interlocking elements. Upon
implantation the
wings 6516 may be located a maximum distance away from implant 25 as allowed
by the
slidable interlocking elements and, after final placement of implant 25, the
wings may be
drawn toward the implant 25 by various methods. For example, the slidable
interlocking
elements may be configured with sloped elements which prevent movement in the
direction away from the longitudinal axis of implant 25 yet allow a
compressive force, for
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example from a surgeon employing hemostats on the surfaces of wings 6516
facing
opposite implant 25, to irreversibly draw the wings 6516 toward implant 25. As
a second
example, a gear can be located on the proximal end 43 of implant 25, which
when driven
by rotational forces, by, for example, a screw driver or hex wrench, can force
wings 6516
to draw toward implant 25 while sliding along the slidable interlocking
elements.
[00371] FIGS. 124A and 124B1 are isometric views of another embodiment of
the
delivery tool 20 coupled and decoupled with the implant 25, respectively. FIG.
124C is an
isometric view of the delivery tool 20 in an exploded state. FIG. 124D is an
enlarged view
of the distal end 120 of the implant arm 110 of the delivery tool 20. As can
be understood
from a comparison of FIGS. 124A-124D and FIGS. 86-88, the delivery tool
embodiment of
FIGS. 124A-124D is substantially similar to the delivery tool embodiment of
FIGS. 86-88,
a main difference being the distal end 120 of the implant arm 110, as shown in
FIG. 124D
is adapted to engage the channels 6514 of the implant 25 described with
respect to FIGS.
123A-123E. For example. The large planar members, keels, or fins 140 and the
small
planar members, keels, or fins 145, as described herein, for example, with
respect to FIG.
19, may match the relative shape and size of the channels 6514 of the implant
25.
Accordingly, the delivery tool embodiment of FIGS. 124A-124D is adapted to
deliver the
implant 25 into the joint region with the wings extending in a plane that is
generally
transverse to the joint plane such that each wing is received into a
respective bone (e.g.,
sacrum or iliac) bordering the joint, as described with respect to FIGS. 123A-
123E.
[00372] As can be understood from FIGS. 124E and 124G, in some embodiments,
the implant has a bore 40 that has a non-circular (e.g., oblong) cross section
as taken
along a cross section plane that is generally perpendicular to the length of
the bore 40
extending through the implant. The delivery tool 20 of FIGS. 124A-D can be
configured to
align a non-circular anchor 30 through the non-circular bore 40 of implant 25.
For
example, as shown in FIG. 124B2, a guide sleeve 100 is concentrically
contained in a
collar 165 of the anchor arm 115. The sleeve 100 has an guide hole 2444 that
has a
non-circular (e.g., oblong) transverse cross section that prevents rotational
movement of
the oblong anchor when distally displaced through the guide hole 2444. The
sleeve 100
may have a groove 2333 extending along a portion of its exterior surface
length that
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mechanically interfaces with a complementary feature defined in the collar,
thereby
preventing rotation of the sleeve within the collar. Since the non-circular
(e.g., oblong)
cross sectioned anchor 30 is prevented from rotation within the
complementarily shaped
guide hole 2444 and the sleeve 100 is prevented from rotation within the
collar 165 due to
the structural impediment presented by the groove 2333, the non-circular
anchor 30 can
be accurately and reliably delivered into the non-circular bore 40 of the
implant 25 of
FIGS. 124E and 124G. The delivery tool 20 can also be configured to be able to
deliver a
non-circular anchor 30 adjacent implant 25. Further, another difference
between the
embodiment of FIGS. 124A-124D and FIGS. 86-88 is that the anchor arm 115 as
shown
in FIGS. 124A-124C is contoured to permit the transverse delivery of the
transfixing
anchor screw 30 (e.g., see FIG. 3) through and/or adjacent the implant 25 and
across the
sacroiliac joint space.
[00373] As can be understood from FIGS. 124E-124H, in one embodiment, a
joint
implant 25 includes a longitudinal axis, a body 25, a distal end 42, a
proximal end 43, a
first wing 6516, a second wing 6516 and a bore 40 extending non-parallel to
the
longitudinal axis. The proximal end is opposite the distal end. The first wing
is connected
to the body near the proximal end and extends distally in an offset manner
from a first
lateral side of the body. The second wing is connected to the body near the
proximal end
and extends distally in an offset manner from a second lateral side of the
body opposite
the first lateral side of the body. The body of the implant tapers extending
proximal to
distal.
[00374] As shown in FIGS. 124E-124H, the joint implant also includes a
first pair of
planar members 55 radially extending from the body of the joint implant. The
first pair of
planar members 55 forms at least a portion of the first and second lateral
sides of the
body from which the first and second wings 6514 are offset. The implant may
also include
a second pair of planar members 50 radially extending from the body of the
joint implant
generally perpendicular to the first pair of planar members 55. The second
pair of planar
members may have a thickness greater than a thickness of the first pair of
planar
members. As already stated, the first and second wings extend distally in an
offset
manner from the respective first and second lateral sides, thereby defining
first and
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second respective gaps or slots 6512 between the wings and the respective
lateral sides.
The bore and the first and second wings reside in generally the same plane.
[00375] As can be understood from FIG. 125A, which is an isometric view of
another
embodiment of the implant 25, the longitudinally extending body 45 may include
helical
spiral threads 6524 rather than keels, fins or planar members 50, 55 that
radially extend
outwardly away from the body 45, as described herein. The helical spiral
threads 6524
engage with the bone in the joint region to prevent migration of the implant
25.
Additionally, in the embodiment shown in FIG. 125A, the body 45 is generally
cylindrical
with anti-migration surface features 355 in the form of ridges or ribs
extending
longitudinally along the body 45. Further, in addition to the bore 40, the
body 45 may
include anchor member receiving features 6520 and 6522, which are
substantially similar
to the bore 40, to provide a choice of a plurality of locations to transfix
the anchor member
30, as described herein. Additionally, bores 40 can allow bone to grow into
the hollow
interior of the implant as discussed below. For example, as shown in FIG.
125A, the body
45 may include three bores, 40, 6520, and 6522 positioned relative to one
another along
the same longitudinal surface of the body 45. The implant 25 may be delivered
into the
joint region with an embodiment of the delivery tool 20 that includes three
collars
supported off of the anchor arm 115 similar to the embodiment of FIG. 110,
except having
at least three longitudinally oriented holes similar to holes 165a and 165b,
which are at
pre-set locations corresponding to the bores 40, 6520, and 6522. The rest of
the features
shown in the implant embodiment of FIG. 125A may be substantially similar to
the
features of implant embodiments described herein.
[00376] As shown in FIG. 125B, which is a longitudinal cross section view
of the
implant 25 of FIG. 125A, the longitudinal body of implant 25 may be
substantially hollow
with a distal end 42 configured with an aperture opening to the hollow
interior. The hollow
interior may be filled with a biological material for promoting bone growth
into the hollow
interior, as discussed above. Additionally, helical threads 6524 may be "T-
shaped" in
cross section in order to hold bone to resist a first bone from moving
relative to a second
bone.
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[00377] As shown in FIG. 126A, which is an isometric view of another
embodiment
of the implant assembly 15, the implant 25 of FIG. 126A is substantially the
implant 25 of
FIG. 125A, a main difference being that the additional bores 6520 and 6522 are
not
included on the body 45. Further, features of the anchor element 30 are
substantially
similar to the features of the anchor element 30 described herein, for
example, with
respect to FIG. 3. However, the anchor element 30 as shown in FIG. 126A
includes
helical spiral threads 6528 at the anchor element distal end 6529. The helical
spiral
threads 6528 of the anchor element 30 are rotationally driven and secured into
the bone.
For example, the anchor element proximal end 6531 may be adapted to engage an
Allen
wrench, hex key, or other tool with a hexagonal cross section to deliver the
anchor
element 30 through the bore 40 and into the bone. Additionally, anchor 30,
when
configured as a screw can be self-tapping.
[00378] As illustrated in FIG. 126C, which is a longitudinal cross section
of the
proximal head of the anchor 30 of FIG. 126A, in one embodiment, the hex key
can be
cannulated and configured to receive an anchor retainer rod with a threaded
end that
engages complementary threads 6537 located on the anchor element proximal end
6531
set below the hex key engagement cutout.
[00379] As illustrated in FIGS. 126A and 126B, the anchor 30 may have
flutes 6533
extending longitudinally down a portion of the shaft configured to engage a
setscrew 6534,
as discussed below, in order to prevent rotation of anchor 30 within the bore
40.
Alternatively, anchor 30 can be configured with spiral flutes. Alternatively,
anchor 30,
whether configured as a screw with threads or as a nail, may be further
configured with
flutes which extend circumferentially in order for a setscrew 6534, as
discussed below, to
engage said flutes and thereby prevent axial movement of anchor 30 within the
bore 40.
[00380] As shown in FIG. 126B, which is a longitudinal cross section view
of the
implant assembly 15 of FIG. 126A, the proximal end 43 of the longitudinal body
of implant
25 may be configured to receive a setscrew 6534, or pair of setscrews
positioned in
longitudinal series in the setscrew hole to lock the setscrews in place
against each other
in the set screw hole. The setscrew 6534 (or the most distal setscrew of a
pair of
setscrews in longitudinal series) can threadably advance distally in the
setscrew hole
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such that a distal end of the setscrew enters the bore 40 to be received in a
groove 6533
and abut against the anchor 30 to resist movement between the anchor 30 and
implant
25.
[00381] As can be understood from FIGS. 125A-126B, in one embodiment, a
joint
implant 25 includes a longitudinal axis, a proximal end 43, a distal end 42, a
body 45, a
bore 40 extending non-parallel to the longitudinal axis, and a helical thread
6524
extending around the body between the proximal and distal ends. The implant
body may
be substantially cylindrical, and the bore may be a single bore 40 (see FIG.
126A) or
multiple bores 40.
[00382] As can be understood from FIGS. 127-128A, the implant arm 110
may include a handle at a proximal end of the implant arm, wherein the handle
includes
an elongated handle member 6532 that has a length perpendicular to a
longitudinal axis
of the implant arm. A radiopaque elongated member 6534 extends through the
elongated
handle member parallel to the length of the elongated handle member. The
radiopaque
elongated member is contained in a non-radiopaque portion of the elongated
handle
member. As indicated in FIG. 128A, the radiopaque elongated member may be two
such
members 6534, 6536 spaced apart from each other in the elongated handle member
6532 and residing in a plane at least parallel with, if not including, a
longitudinal axis of the
implant arm 110.
[00383] As can be understood from FIGS. 126A-126B, the joint implant
may
also include a setscrew 6534 with a distal end that is configured to enter the
first bore 40
to abut against the anchor element 30 so as to limit movement of the anchor
element in
the first bore. For example, in abutting against the anchor element, the
distal end of the
setscrew engages a flute 6533 defined in the anchor element.
[00384] FIG. 127 is an isometric view of an embodiment of a sleeve 6550
mounted
on an implant arm 110 of a delivery device 20 similar to that of FIG. 88,
wherein the sleeve
facilitates visualization of trans screw trajectory. When delivering the
implant 25, the arm
assembly 85 is decoupled from the implant arm 110 and the sleeve 6550 is
coupled to the
implant arm 110. The handle members 6532 may be rotated to cause implant arm
110 to
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rotate, thereby causing the helical spiral threads 6526 to threadably engage
the bone and
advancing the implant 25 into the joint region. In one embodiment, the sleeve
6550,
which may be formed of a radiotranslucent material such as PEEK or carbon
fiberõ
includes a tantalum inlay 6534 for transcrew trajectory visualization. In
other words, the
handles 6532 may include a cylindrical member 6534, which is a radiopaque
marker to
aid in alignment, for example, using fluoroscopy with the x-ray beam aligned
generally in
parallel relation to the joint. The marker 6534 runs within the handle 6532
parallel to a
longitudinal center axis of the handle. Once the implant 25 is implanted in
the joint space
as desired, the sleeve 6550 can be removed from the implant arm 110 and the
arm
assembly 85 with its anchor arm 115 can be coupled to the implant arm 110 in
order to
allow for the guided delivery of the anchor 30 into the bore 40 of the implant
25 as
described herein. As can be understood from FIG. 128A, which is an isometric
view of
another embodiment of the sleeve 6550 of FIG. 127, the features of the sleeve
of FIG.
127 are substantially the features of the sleeve embodiment of FIG. 128A, a
main
difference being that the handle members 6532 of the embodiment of FIG. 128
include
another cylindrical member 6536, which may be another radiopaque marker for
alignment
visualization. Both markers 6534 and 6536 run within the handle 6532 parallel
to a
longitudinal center axis of the handle.
[00385] FIG. 128B is an end view of sleeve 6550 of FIG. 128A showing
overlapping
radiopaque markers 6534 and 6536, which are configured with terminal circle
shaped
markers 6555. FIG. 128C is a posterior view of the hip region, wherein the
sleeve 6550 is
being employed. As can be understood from FIGS. 128A-128C, the configuration
of the
sleeve 6550 permits the operator (e.g. surgeon, computer controlled navigation
system,
or surgical robot) to visualize and adjust with rotational force the
trajectory, relative to
anatomic structures, of an anchor 30 which can pass through a bore 40 or pass
adjacent
to implant 25 in order to avoid violating neurovascular structures or other
implants which
may already be present or are anticipated to be implanted in proximity to
implant
assembly 15.
[00386] As can be understood from FIGS. 128A-1280, when the implant 25 is
coupled to the implant arm 110, a longitudinal axis of the implant 25, a
longitudinal axis of
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the bore 40, and the longitudinal axes of the radiopaque elongated members
6534, 6536
exist in a common plane. In other words, when the implant 25 is coupled to the
implant
arm 110, the two radiopaque elongated members 6534, 6536, which are spaced
apart
from each other in the elongated handle member 6532, reside in a plane at
least parallel
with, if not including, a longitudinal axis of the implant arm 110 and/or a
longitudinal axis of
the bore 40. As a result, as can be understood from FIGS. 128A-1280, the
radiopaque
members can be used to ascertain the location and orientation of the bore when
the
implant is located within the joint space, thereby helping the physician to
understand if the
anchor to be delivered to or near the implant will adversely impact
neurovascular
structures.
[00387] Refering to FIG. 128B, it can be seen that the two radiopaque
markers 6534,
6536 form a single line when viewed along the plane in which both radiopaque
markers
reside. This single line idicates to the physician the orientation of the bore
40 and a
trajectory of an anchor that would be received in the bore 40. Other
radiopaque markers
may be located on the handle 6550 to convey other information to the
physician. For
example, additional radiopaque markers similar to markers 6534, 6536 may be
located
parallel to, and offset from, markers 6534, 6536 so as to convey to the
physician a
trajectory of an anchor intended to not pass through the bore, but to instead
pass adjacent
to a side of the implant.
[00388] FIGS. 129A-129B show isometric views of another embodiment of the
system 10, wherein the delivery tool 20 has a header 6539 with a series of
collars 165 and
associated sleeves 100 having a variety of pre-defined angular alignments to
guide one
or more transfixing anchor members 30 into place, thereby providing a choice
of delivery
angles that are complementary to the implant 25. According to particular
embodiments, a
sleeve or collar 165 of the header 6539 depicted in FIGS. 129A-129B may have a
longitudinal center axis LCA1 similar to the longitudinal center axis LCA1
depicted in FIG.
18, the a longitudinal center axis LCA1 being aligned with a trajectory which
either passes
into or through a bore 40 of the implant 25 or passes near an implant 25 to
further locate
an anchor 30 into the bone of a sacrum within certain desirable areas to avoid
neurovascular elements and to place the anchor within sacral bone with a
higher bone
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density. For example, depending on the trajectory of the implant 25 and the
location of
the bore 40 when LCA1 is aligned with said bore versus placing an anchor near
an implant
and not through a bore, an anchor can terminate generally within the sacral
ala, or
terminate in the body of the first sacral vertebra while avoiding the first
sacral foramina, or
terminate in a S2 vertebral body between the first and second sacral foramena,
or
terminate into the apex of the sacral promontory, or terminate through or
within an
anterior sacral cortex, or terminate through or near an Si endplate.
[00389] The system 10 includes a delivery tool 20 and an implant 25 for
implanting
at the sacroiliac joint via the delivery tool 20, the implant 25 being for
fusing the sacroiliac
joint. As shown in FIGS. 129A and 129B, the delivery tool 20 includes an
implant arm 110
and an anchor arm 115. As described herein, the implant arm 110 is configured
to
releasably couple to the implant 25, and the anchor arm 115 is coupled to the
implant arm
110 and configured to deliver the anchor element 30 to the bore 40 of the
implant 25. An
impactor arm 6546 of the impactor assembly 6550 is removably coupled to handle
members 6538 of the arm assembly 85. Additionally, the impactor arm 6546 is
removably
coupled to the implant arm 110. When the impactor assembly 6550 is coupled to
the
handle members 6538 as shown in FIG. 129B, impacting an impactor handle 6547
of the
impactor assembly 6550 distally causes the implant arm 110, and the rest of
the
assembly 10 as whole, to displace distally and deliver the implant 25 into the
sacroiliac
joint space. The delivery tool 20 further includes a retaining member 6548
configured to
couple the arm assembly 85 to the implant arm 110 and to engage the implant
25. The
other features of the retaining member 6548 may be substantially similar to
the retaining
member 95 as described above with respect to FIGS. 28-29. Specifically, the
retainer
member 6548 extends through the implant arm 110 to mechanically interlock with
a bore
(e.g., center bore 70) of the implant 25 as described herein. During delivery
of the implant
25, the arm assembly 85 may be decoupled from the delivery tool 20 for easier
delivery of
the implant 25 into the joint region. Additionally, the markers 6534 and 6536
can be
removable.
[00390] As discussed below in greater detail, during the implantation of
the implant
assembly 15 at the sacroiliac joint, the implant 25 is supported by the
implant arm 110 and
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the arm assembly 85 with its collar header 6539 may be coupled to the implant
arm 110 to
guide and support one or more anchor elements 30 (not shown). The handle
members
6538 may be used to position or guide the implant as it is being distally
driven into the
sacroiliac joint via impacts delivered to the impactor handle 6547. In some
embodiments,
the handle 6538 may be constructed of a radiolucent material and may include
radiopaque markers 6534 and 6536 similar to those shown in FIGS. 127 and 128
for
positioning the implant in the plane of the joint under fluoroscopy.
[00391] As described below, the delivery tool 20 is then used to cause the
one or
more anchor elements 30 to extend through the ilium, the sacrum and the
implant 25
generally transverse to the sacroiliac joint and implant 25. The delivery tool
20 is then
decoupled from the implanted implant assembly 15, as described herein.
[00392] The arm assembly 85 includes the anchor arm 115 with a collar
header
6539 extending from the anchor arm. The collar header includes a series of arm
members 6540, 6542, and 6544 in which a series of collars 165 are defined at
different
horizontal and vertical angles. The anchor arm 115 is coupled to the implant
arm 110 via
the handle members 6538. Depending on the embodiment, the horizontal linear
arm
member 6540 may include five collars 165e, 165f, 165g, 165h, and 165i, each
providing
different alignment angles, the horizontal linear arm member 6542 may include
two
collars 165k and 165j, each providing different alignment angles. The vertical
arcuate
arm member 6544 may include one additional collar 1651 plus already mentioned
collar
165f, each providing different alignment angles. It will be appreciated that
the collar
positions and alignments shown in the embodiment of FIGS. 129A-C are for
illustrative
purposes only and that other positions and alignments are contemplated.
[00393] In one embodiment, as shown in FIGS. 124A-1240, the anchor arm 115
is
contoured having an arcuate shape. The anchor arm 115 is received in a
vertically
extending arm member 6544 of the header 6539. The vertically extending arm
member
6544 has an arcuate configuration over its vertical extension that is
generally the same as
the arcuate configuration of the anchor arm 115 with respect to degree of
curvature. Thus,
the vertical arcuate arm member 6544 extends from the anchor arm 115 following
the
same general arcuate path. The arcuate arm member 6544 may be thicker relative
to the
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anchor arm 115 to provide stability during the delivery of the one or more
anchor
members 30 and sufficient width to accommodate the collars 165f and 1651
defined
therein as shown in FIG. 1290. The collars 165f and 1651 are defined in the
generally
planar surface of the vertical arcuate arm member 6544.
[00394] The collar header 6539 may further include horizontal linear arm
members
6540 and 6542, which extend perpendicularly from the vertical arcuate arm
6544.
Members 6540 and 6542 may be manufactured in a fixed configuration or
removable
configuration with fixed attachment points located along collar header 6539.
The
horizontal linear arm members 6540 and 6542 have a relative thickness similar
to the
vertical arcuate arm member 6544 and are generally linear. The horizontal
linear arm
members 6540 and 6542 include one or more collars 165e-165i and 165k-165j
defined on
a generally planar surface of each of the horizontal linear arm members 6540
and 6542.
The generally planar surfaces of the horizontal linear arm members 6540 and
6542
intersect with the general planar surface of the vertical arcuate arm member
6544 to form
a substantially single generally planar surface, as shown best in FIG. 1290.
Accordingly,
one or more of the collars 165f may be positioned on an intersecting surface
of the
arcuate arm member 6544 and one of the linear arm members 6540 or 6542.
[00395] Each of the collars 165 are configured to receive a sleeve 100 to
cause the
one or more anchor elements 30 to extend through the ilium, the sacrum and the
implant
25 (and/or immediately adjacent to the implant) generally transverse to the
sacroiliac joint
and implant 25, as described herein. Some collars 165, such as collars 165f,
165i and
1651, may be axially aligned with respective bores of the implant 25 when the
implant 25 is
supported off of the distal end of the implant arm 110 of the tool 20. As a
result, an anchor
member 30 may be delivered into each of the bores via the respective anchor
collars 165.
Collars 165f, 165i and 1651 are each indicated to be directed to the bore 40
by a marker
6543 showing two concentric circles. As discussed below and can be understood
from
FIG. 129C, collar 1651 has a zero degree horizontal offset by virtue of being
on the vertical
arm 6544, which is in parallel alignment to the plane occupied by the implant
arm 110 and
anchor arm 115. However, collar 1651 has a 90 degree vertical offset to the
longitudinal
axis of the implant arm 110 and the implant 25 mounted thereon such that a
sleeve 100
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extending through the collar 1651 extends in the plane occupied by the implant
arm and
anchor arm and further extends perpendicular to the longitudinal axis of the
implant arm
and implant. Because collar 1651 is aligned with the bore 40, the anchor
delivered to the
bore by the sleeve extending through collar 1651 will orient the anchor in the
bore in a
plane occupied by the implant arm and anchor arm, but perpendicular to the
longitudinal
axis of the implant. Collar 1651 may include three overlapping bores that
provide a 90
degree alignment angle (or slight angular variations greater than or less than
90 degrees),
thereby allowing placement of an anchor 30 (or multiple anchors in general
parallel
relation), for example through a slot or multiple bores 40 in implant 25, at
varied distances
between implant ends.
[00396] As can be understood from FIG. 1290, collar 165f has a zero degree
horizontal offset by virtue of being on the vertical arm 6544, which is in
parallel alignment
to the plane occupied by the implant arm 110 and anchor arm 115. However,
collar 165f
has a 45 degree vertical offset to the longitudinal axis of the implant arm
110 and the
implant 25 mounted thereon such that a sleeve 100 extending through the collar
1651
extends in the plane occupied by the implant arm and anchor arm and further
extends at
a 45 degree angle to the longitudinal axis of the implant arm and implant.
Because collar
165f is aligned with the bore 40, the anchor delivered to the bore by the
sleeve extending
through collar 165f will orient the anchor in the bore in a plane occupied by
the implant
arm and anchor arm, but at 45 degrees to the longitudinal axis of the implant.
[00397] As can be understood from FIG. 1290, collar 165i has a 30 degree
horizontal offset by virtue of being on horizontal arm 6540 at a 30 degree
location. In
other words, a sleeve 100 extending through collar 165i will approach the
implant at an
angle that is 30 degrees right of the plane occupied by the implant arm 110
and anchor
arm 115. Further, because horizontal arm 6540 is centered horizontally on
collar 165f,
which has a 45 degree vertical offset to the longitudinal axis of the implant
arm 110 and
the implant 25 mounted thereon, collar 165i will have a 45 degree vertical
offset as
described with respect to collar 165f. Thus, a sleeve 100 extending through
collar 165i
extends at a 30 degree horizontal offset angle to the plane occupied by the
implant arm
and anchor arm and further extends at a 45 degree offset angle to the
longitudinal axis of
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the implant arm and implant. Because collar 165i is aligned with the bore 40,
the anchor
delivered to the bore by the sleeve extending through collar 165i will orient
the anchor in
the bore 30 degrees offset from the plane occupied by the implant arm and
anchor arm
and at 45 degrees to the longitudinal axis of the implant.
[00398] The collars 165e, 165g, 165h, 165j and165k may be employed to
deliver
anchor members 30 into the bone of the ilium and sacrum while not passing
through a
bore 40 of the implant 25 (i.e., according to particular embodiments,
preconfigured to
place anchor members 30 immediately adjacent the longitudinal side edges of
the implant
25). Such offset placement collars 165e, 165g, 165h, 165j and 165k are each
indicated
as such by a marker 6547 showing a circle tangent to a rectangle, as
illustrated in FIG.
1290.
[00399] As can be understood from FIG. 1290, collar 165h has a 30 degree
horizontal offset by virtue of being on horizontal arm 6540 at a 30 degree
location. In
other words, a sleeve 100 extending through collar 165i will approach the
implant at an
angle that is 30 degrees right of the plane occupied by the implant arm 110
and anchor
arm 115 and, because the adjacent marker 6547 indicates that the anchor 30
will be
delivered adjacent to the implant 25 and not through its bore 40, the anchor
will be
delivered at the 30 degree angle to the left of the implant. Further, because
horizontal
arm 6540 is centered horizontally on collar 165f, which has a 45 degree
vertical offset to
the longitudinal axis of the implant arm 110 and the implant 25 mounted
thereon, collar
165h will have a 45 degree vertical offset as described with respect to collar
165f. Thus,
a sleeve 100 extending through collar 165h extends at a 30 degree horizontal
offset angle
to the plane occupied by the implant arm and anchor arm and further extends at
a 45
degree offset angle to the longitudinal axis of the implant arm and implant.
Because collar
165h is not aligned with the bore 40, the anchor will be adjacent the implant
(i.e., not in the
bore 40). Also, the anchor 30 delivered by the sleeve extending through collar
165h will
orient the anchor adjacent the implant 30 degrees offset from the plane
occupied by the
implant arm and anchor arm and at 45 degrees to the longitudinal axis of the
implant.
[00400] As can be understood from FIG. 1290, collar 165j has a 20 degree
horizontal offset by virtue of being on horizontal arm 6542 at a 20 degree
location. In
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other words, a sleeve 100 extending through collar 165j will approach the
implant at an
angle that is 20 degrees right of the plane occupied by the implant arm 110
and anchor
arm 115 and, because the adjacent marker 6547 indicates that the anchor 30
will be
delivered adjacent to the implant 25 and not through its bore 40, the anchor
will be
delivered at the 20 degree angle to the left of the implant. Further, because
horizontal
arm 6542 is centered horizontally at a 70 degree vertical offset to the
longitudinal axis of
the implant arm 110 and the implant 25 mounted thereon, collar 165j will have
a 70
degree vertical offset. Thus, a sleeve 100 extending through collar 165j
extends at a 20
degree horizontal offset angle to the plane occupied by the implant arm and
anchor arm
and further extends at a 70 degree offset angle to the longitudinal axis of
the implant arm
and implant. Because collar 165j is not aligned with the bore 40, the anchor
will be
adjacent the implant (i.e., not in the bore 40). Also, the anchor 30 delivered
by the sleeve
extending through collar 165j will orient the anchor adjacent the implant 20
degrees offset
from the plane occupied by the implant arm and anchor arm and at 70 degrees to
the
longitudinal axis of the implant.
[00401] As can be understood from FIG. 1290, collar 165e has a leftward
parallel
offset by virtue of being on horizontal arm 6540 at a leftward parallel offset
location. In
other words, a sleeve 1 00 extending through collar 165e will approach the
implant
leftward offset from, and parallel to, the plane occupied by the implant arm
110 and
anchor arm 115 and, because the adjacent marker 6547 indicates that the anchor
30 will
be delivered adjacent to the implant 25 and not through its bore 40, the
anchor will be
delivered at such a parallel arrangement and to the left of the implant.
Further, because
horizontal arm 6540 is centered horizontally on collar 165f, which has a 45
degree vertical
offset to the longitudinal axis of the implant arm 110 and the implant 25
mounted thereon,
collar 165e will have a 45 degree vertical offset as described with respect to
collar 165f.
Thus, a sleeve 100 extending through collar 165e extends at a leftward
parallel offset to
the plane occupied by the implant arm and anchor arm and further extends at a
45 degree
offset angle to the longitudinal axis of the implant arm and implant. Because
collar 165e
is not aligned with the bore 40, the anchor will be adjacent the implant
(i.e., not in the bore
40). Also, the anchor 30 delivered by the sleeve extending through collar 1
65h will orient
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the anchor adjacent the implant at the leftward parallel offset from the plane
occupied by
the implant arm and anchor arm and at 45 degrees to the longitudinal axis of
the implant.
[00402] As can be understood from FIG. 1290, collar 165k has a leftward
parallel
offset by virtue of being on horizontal arm 6542 at a leftward parallel offset
location. In
other words, a sleeve 100 extending through collar 165k will approach the
implant
leftward offset from, and parallel to, the plane occupied by the implant arm
110 and
anchor arm 115 and, because the adjacent marker 6547 indicates that the anchor
30 will
be delivered adjacent to the implant 25 and not through its bore 40, the
anchor will be
delivered at such a parallel arrangement and to the left of the implant.
Further, because
horizontal arm 6542 is centered horizontally at a 70 degree vertical offset to
the
longitudinal axis of the implant arm 110 and the implant 25 mounted thereon,
collar 165k
will have a 70 degree vertical offset. Thus, a sleeve 100 extending through
collar 165k
extends at a leftward parallel offset to the plane occupied by the implant arm
and anchor
arm and further extends at a 70 degree offset angle to the longitudinal axis
of the implant
arm and implant. Because collar 165k is not aligned with the bore 40, the
anchor will be
adjacent the implant (i.e., not in the bore 40). Also, the anchor 30 delivered
by the sleeve
extending through collar 165j will orient the anchor adjacent the implant at
the leftward
parallel offset from the plane occupied by the implant arm and anchor arm and
at 70
degrees to the longitudinal axis of the implant.
[00403] Because of the multiple collars 165, the delivery tool 20 may be
adjusted to
accommodate patients of different sizes and still maintain the angular
relationships
between the components of system 10 that allows one or more anchor members 30
to be
delivered into a bore of the implant 25 and/or into the bone of the ilium and
sacrum
immediately adjacent the implant, or around the implant with anchor 30 passing
through
regions 3007 or 1044, without any further adjustment to the delivery tool 20.
Because the
angular relationships are rigidly maintained between the arms 110, 115, the
arm
members 6540, 6542, and 6544, the collars 165 of the header 6539, and the
implant 25,
the anchoring of the implant 25 in the sacroiliac joint via one or more anchor
members 30
may be achieved quickly and safely. In other words, because the delivery tool
20, via the
multi-angle collar options of the header 6539, provides multiple angular
alignments for
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deploying one or more anchor members 30 and does not need to be adjusted with
respect
to angular relationships, the surgery is simplified, reduced in duration, and
reduces the
risk of an anchor member 30 being driven through a nerve, artery or vein.
Additionally,
collars may be color coded to correspond with particular implants of the same
color, which
indicates a complementary configuration. Furthermore, sleeves 100 may
encounter
interference elements within the collars to restrict or reduce axial movement
of the sleeve
during the course of the procedure (e.g., see discussion above with respect to
FIG.
124B2).
[00404] While any one or more of the implant embodiments disclosed herein
could
be employed with the delivery device discussed with respect to FIGS. 129A-
129C, one
version of the implant as now discussed with respect to FIGS. 129D-129L may be
especially advantageous. FIGS. 129D-129K are various views of the implant 25,
and FIG.
129L is an enlarged isometric view of the implant 25 of FIGS. 129D-129K
mounted on the
extreme distal end of the implant arm 110 of the delivery tool 20 of FIGS.
129A-129C.
[00405] As shown in FIGS. 129D-129K, the implant 25 includes a distal end
42 and
a proximal end 43. The implant also includes a middle planar member 6579 in
which a
central bore slot 40 is defined so as to extend through the middle planar
member 6579.
The bore slot 40 may be an elongated oval shape that has a longitudinal axis
that is
parallel with the longitudinal axis of the implant 25. The elongated shape
allows for an
anchor 30 to be delivered through the bore slot 40 at a variety of angles via
the collars
165f, 165i, and 1651 discussed above with respect to FIG. 129C.
[00406] The distal end 42 of the middle planar member 6579 has a truncated
shape
with chamfered edges transition between the planar sides of the planar member
and the
blunt planar distal face of the distal end of the middle planar member. A
small planar wing
6580 forms a T-shaped perpendicular intersection with a first lateral edge of
the middle
planar member 6579, and a large planar wing 6581 forms a T-shaped
perpendicular
intersection with a second lateral edge of the middle planar member 6579
opposite the
first lateral edge of the middle planar member. Accordingly, as can be
understood from
FIGS. 129J and 129K, the implant has an I-shaped cross section as viewed from
either
the distal or proximal ends, the large wing 6581 having a substantially larger
(e.g., nearly
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double) width than the small wing 6580. Additionally, as illustrated in FIGS.
129J and
129K, the implant 25 may include one or more bore shafts 10020 extending
between, and
daylighting at, the implant distal end 42 and implant proximal end 43. Such
shafts 10020
areconfigured to receive or pass over, for example, guide pins placed in the
plane of a
sacroiliac joint.
[00407] As illustrated in FIG. 129D, like the distal end 42 of the middle
planar
member 6579, the distal ends of the wings 6580 and 6581 also have truncated
shapes
with chamfered edges transitioning between the planar sides of the wings and
the blunt
planar distal faces of the distal ends of the wings. While the planar surfaces
of the small
wing 6580 may be generally smooth, the planar surfaces of the large wing 6581
may have
longitudinally extending evenly spaced apart grooves 6582 defined therein.
Alternatively,
grooves 6582 may extend perpendicular to length of the implant.
[00408] As shown in FIGS. 129E, the proximal end 43 of the implant 25 has a
groove 6514 that extends from wing to wing across the blunt proximal end 43 of
the
implant, the groove even extending into the outermost planar surfaces of the
wings 6580
and 6581. As can be understood from FIG. 129L, when the implant 25 is mounted
on the
extreme distal end of the implant arm 110, members 140 similar to those
already
described herein with respect to FIG. 124D are received in the groove 6514,
and the
central cylindrical member 220 of the retaining member 95 is received in the
proximal
opening 70 to retain the implant securely on the distal end of the implant arm
110.
[00409] As indicated in FIGS. 129E and 129L, the implant 25 may have
similar
alignment marks 6583 that help a user to properly mount the implant on the
implant arm
distal end in a correct orientation relative to each other.
[00410] While all the various embodiments of the implant arm 110 discussed
above
are illustrated in their associated figures as having an arrangement that
results in the
implant 25 being supported off of the distal end 120 of the implant arm 110
such that the
longitudinal axis of the implant arm is essentially axially aligned with the
longitudinal axis
of the implant arm, in other embodiments, as mentioned above, the implant can
be
supported off of the distal end of the implant arm in other manners. For
example, as can
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be understood from FIG. 129M, the distal end 120 of the implant arm 110, which
forms a
distal end 35 of the overall delivery device 20, may be oriented so as to
support the
implant 25 such that the longitudinal axis of the implant is offset from, but
substantially
parallel to the longitudinal axis of the implant arm 110. Alternatively, as
can be
understood from FIG. 129N, the distal end 120 of the implant arm 110 may be
oriented so
as to support the implant 25 such that the longitudinal axis of the implant is
substantially
non-parallel to the longitudinal axis of the implant arm 110. For example, the
longitudinal
axis of the implant may form an acute angle (e.g., 45 degree) angle with the
longitudinal
axis of the implant arm. Alternatively, the implant arm and sleeve can be
arcuate.
Regardless of whether the longitudinal axis of the implant is axially aligned
with, parallel
with, or at an acute angle with the longitudinal axis of the implant arm, the
overall delivery
device with be so configured such that an anchor 30 can be delivered via the
implant arm
115 to a bore 40 in the implant 25 and/or a predetermined location immediately
adjacent
the implant without having to adjust an angular relationship between the
implant arm and
the anchor arm.
[00411] As shown in FIG. 129P, the implant arm 110 of FIGS. 129M and 129N
may
be formed mainly of a sleeve 110Z and a retainer rod 110X. The retainer rod
110X may
be received coaxially within the sleeve 110Z, as illustrated in FIGS. 129M and
129N.
[00412] The retainer rod 110X includes a shaft 10030 that distally
terminates in
opposed arms 10032, which in turn terminate in retainer arms or prong arms
140. As
shown in FIG. 129P, when the rod 110X is free of the sleeve 110Z, the opposed
arms
10032 are biased apart, resulting in a space-apart distance indicated by arrow
D that is
sufficiently wide to allow the implant 25 to be received between the prong
arms 140 at the
rod distal end 120.
[00413] As indicated in FIG. 129P, the sleeve 110Z includes a distal end
10040, a
proximal end 10042, slots 10044 that extend into the hollow interior of the
shaft of the
sleeve 110Z. The slots 10044 provide opening into the hollow interior to
facilitate
sterilization of the sleeve 110Z via an autoclave. A knurled gripping surface
10046 is
defined near the sleeve proximal end 10042 so as to facilitate rotation of the
sleeve
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relative to the rod when the threads 110Y are being threadably engaged.
[00414] As can be understood from a comparison of FIGS. 129M, 129N and
129P,
when the sleeve 110Z is advanced distally over the retainer rod 110X,
complementary
threads 110Y on both the sleeve 110Z and retainer rod 110X can be engaged and
the
sleeve can be rotatably driven distally by said thread engagement. The sleeve
110Z
advancing distally causes prong arms 140 of the retainer rod 110X to draw
toward one
another and in turn cause the portion of the retainer rod which couples to the
implant 25 to
grasp said implant as can be understood from FIGS. 129L, 131G and 131H. The
complementary threads when engaged may prevent proximal movement of the sleeve
110Z relative to the rod 110X and allow the coupling of implant and retainer
rod to
continue throughout the course of the procedure. After implantation the sleeve
110Z may
be caused to move proximally along the retainer rod 110X in order to decouple
the
aforemention tool and implant arrangement.
[00415] To illustrate the methodology associated with employing the
delivery tool 20
of FIGS. 129A-129C in implanting any of the above-described implants 25 in the
sacroiliac joint 1000 of a patient 1001, reference is made to FIGS. 130A-1301.
Specifically,
FIGS. 130A-130B show anterior views of the hip region with the system of FIGS.
129A-1290, wherein the ilium is shown and hidden, respectively. FIGS. 1300-
130G
show anterior-superior-lateral, posterior, superior, lateral, and inferior
views of the hip
region with the system of FIGS. 129A-129C. FIGS. 130H and 1301 show inferior
and
posterior-lateral views of a patient, wherein the system of FIGS. 129A-1290 is
inserted
through the soft tissue of the hip region. As can be understood from FIGS.
130A-130I, the
curvature of the anchor arm 115 and the arm members 6540, 6542, and 6544
mirror the
shape of the hip region 1002 to simplify surgery and increase reliability of
alignment. Also,
the implant 25 may be inserted into the sacroiliac joint via the implant arm
110 via the
approach discussed in detail with respect to FIGS. 103A-108A, the main
difference being
that the multi-collar header 6539 facilitating the delivery of the one or more
anchors 30
into or around implant at a variety of locations and angled approaches.
[00416] A tool similar to that of FIGS. 129A-129C can be configured to be
employed
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for the approaches illustrated in FIGS. 111-112. For example, for an approach
similar to
FIG. 111, a tool similar to FIGS. 129A-129C may be configured without collars
165e,
165g-165h, 165j and 165k, because these omitted collars if used for a
procedure as
shown in FIG. 111 could undesirably direct an anchoranterior of the sacrum or
ilium and
outside a safe and desirable anchor trajectory. Additionally, collar 165i may
be employed
to direct an anchor 30 which passes through an ilium and into and terminating
in a bore 40
of an implant 25 as to not pass into the bone of the sacrum.
[00417] As another example, a tool similar to FIGS. 129A-1290 may be
configured,
with 6540 and 6542 being mirrored over 6544 as to generally direct an anchor
through a
bore 40 of an implant 25 with a trajectory that is more anterior to posterior
or which directs
an anchor generally posterior to an implant 25 when the anchor is being
positioned
adjacent to an implant 25.
[00418] According to particular embodiments, for example, for an approach
similar
to FIG. 112, a tool similar to FIGS. 129A-129C may be configured without
collars 165e,
165g-h, 165j and 165k, because these omitted collars if used for a procedure
as shown in
FIG. 112 could undesirably direct an anchorinferior to the sciatic notch and
outside a safe
and desirable anchor trajectory. As an example, a collar or series of collars
could be
configured to align with a bore 40 or aligned to pass an anchor 30 above or
superior to an
adjacent implant 25 with, for example, collars with a 45-70 degree vertical
offset to the
longitudinal axis of the implant arm 110 (and the implant 25 mounted thereon),
and 0-45
degree horizontal offset (with 0 degrees being parallel alignment to the plane
occupied by
the implant arm 110 and anchor arm 115).
[00419] As can be understood from FIGS. 131A-131B, which show isometric
views
of another embodiment of the system 10, the delivery tool 20 of FIGS. 131A-
131B is
substantially the delivery tool of FIGS. 129A-1290, a main difference being
that the collar
header 6539 does not include the second horizontal linear arm member 6542
extending
from the vertical arcuate arm member 6544 and that the arm members 6540 and
6544
include fewer collars165, as described below with respect to FIG. 131C.
Specifically, the
first horizontal linear arm member 6540 and the vertical arm 6544 of the
embodiment of
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FIGS. 131A-131C include the same collar locations, angular arrangements and
markers
as is the case of the arms 6540 and 6544 of the embodiment of FIGS. 129A-129C.
FIGS.
131A-131C show the impactor assembly 6550 decoupled from the implant arm 110
and
the handle members 6538. However it will be understood that the impactor
assembly
6550 may be coupled to the implant arm 110 and the handle members 6538, as
described
with respect to FIGS. 129A-1290.
[00420] For a detailed discussion of the angular alignments of the collars
165,
reference is made to FIG. 131C, which shows an enlarged view of the arm
assembly 85
with the collar header 6539. As discussed with respect to FIG. 129C, the
horizontal linear
arm member 6540 intersects with the vertical arcuate arm member 6544 such that
one or
more of the collars 165 may be positioned on both the arcuate arm member 6544
and the
linear arm member 6540. As shown in FIG. 131C, the arcuate arm member 6544 may
include two linearly aligned collars 165p and 165q providing different
alignment angles
that are respectively the same as collars 165f and 1651 of the embodiment
discussed with
respect to FIG. 129C. For example, the collar 165p may provide a 45 degree
alignment
angle and the collar 165q may include three overlapping bores that provide a
90 degree
alignment angle. The linear arm member 6540 may include four collars 165p,
1650, 165n,
and 165m that are respectively the same as collars 165f, 165g, 165h and 165i
of the
embodiment discussed with respect to FIG. 1290. For example, the collar 165o
may
provide a 15 degree alignment angle and the collars 165n and 165m may each
provide a
30 degree alignment angle from different locations on the linear arm member
6540. It will
be appreciated that the collar positions and alignments shown in the
embodiment of FIGS.
131A-C are for illustrative purposes only and that other positions and
alignments are
contemplated.
[00421] FIGS. 1310-131E are isometric view of a version of the implant of
FIGS.
129D-121K adapted for use with the delivery system of FIGS. 131A-1310. As can
be
understood from a comparison of implant embodiment shown in FIGS. 131D-131E to
the
implant embodiment illustrated in FIGS. 129D-129E, the main difference between
the two
version of the implant is that the elongated single bore slot 40 has changed
to two circular
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bores 40. Polyethylene bushings may define a portion of the bore holes 40 of
FIGS.
131D-131E.
[00422] In one embodiment, the implant 25 and a distal extension 5777 of
the distal
end of the implant arm 110 can be configured to receive and remove cartilage
from the
sacroiliac joint. For example, as shown in FIG. 131F, which is an isometric
view of a
version of the implant of FIGS. 129D-129K, the body 45 of the implant 25 is
hollow along
its longitudinal length and daylights at its proximal end 43 and distal end 42
in the form of
proximal opening 5778 and distal opening 5779. The side walls of the body 45
extending
between the large wing 6581 and small wing 6580 may include openings 5780 that
extend into the hollow interior of the body 45. The openings may have a
triangular or
other shape.
[00423] As illustrated in FIG. 131G, which is an isometric view of the
distal extension
5777 of the distal end of the implant arm 110, the distal extension 5777 is a
hollow
rectangular box having generally smooth outer wall surfaces. As can be
understood from
FIG. 131H, which is an isometric view of the implant arm distal extension 5777
received in
the hollow body of the implant 25, the distal extension 5777 is configured to
be received in
a mating fashion that substantially matches and fills the hollow body of the
implant 25
when the implant is supported off of the distal end of the implant arm 110.
The matching
arrangement between the distal extension 5777 and the hollow interior of the
body 45 of
the implant 25 is readily understandable from FIG. 1311, which is an isometric
longitudinal
cross section of the implant arm distal extension and implant supported
thereon as taken
along section line 1311-1311 of FIG. 131H. As indicated in FIG. 1311, the
interior wall
surfaces of the implant arm distal extension 5777 includes raised teeth-like
ridges 5781
that are oriented proximally to prevent cartilage contained in the hollow
interior of the
extension 5777 from distally exiting the extension 5777.
[00424] In use, the implant 25 is supported on the extension 5777 as
depicted in
FIGS. 131H and 1311 and driven into the sacroiliac joint, thereby causing
cartilage to be
sliced by the leading distal rectangular edges 5782 of the extension 5777 and
received in
the confines of the hollow interior of the extension 5777. Once the implant 25
is
positioned as desired in the sacroiliac joint and then decoupled from the
distal end of the
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implant arm 110, the implant arm 110 can be proximally withdrawn, thereby
causing the
extension 5777 to proximally exit the confines of the hollow interior of the
implant body 45.
As the extension 5777 proximally withdraws, the teeth 5781 engage the
cartilage located
in the confines of the hollow extension 5777, causing the cartilage to be
maintained in the
confines of the hollow extension as it is proximally withdrawn from the
sacroiliac joint,
thereby extracting the cartilage from the sacroiliac joint. The void resulting
from the
withdrawal of the cartilage, which happens to be the hollow interior of the
implant body 45,
can then be filled with a metal or polymer structure to support the walls of
the implant body
45 or, alternatively, the void can be filled with a bone growth promoting
material to cause
bone to infill the body of the implanted implant.
[00425] In one embodiment, the hollow extension 5777 is not part of the
distal end of
the implant arm 110, but is instead simply an insert 5777 portion of the
implant 25. Thus,
the insert 5777 is placed in the implant 25 and both are then supported off of
the distal end
of the implant arm 110. The implant and insert 5777 are then driven into the
sacroiliac
joint. The implant and insert 5777 are then decoupled from the distal end of
the implant
arm 110 and left in the sacroiliac joint as the implant arm 110 is proximally
withdrawn from
the patient. The extractor 6583 described below with respect to FIGS. 134A-
134E can
then be employed to extract the cartilage filled insert 5777 from the confines
of the implant
25, which remains behind in the sacroiliac joint.
[00426] FIG. 132A is an isometric view of yet another embodiment of the
system 10
for fusing a sacroiliac joint. The system 10 includes an impactor assembly
6550, an
impactor arm 110, and a retainer 6548, which is substantially the impactor
assembly,
impactor arm, and retainer described with respect to FIGS. 129A-129C. The
system 10
further includes an arm assembly 85 having handle members 6528, which have
substantially the same features as the handle members 6538 described with
respect to
FIGS. 129A-129C, a main difference being that the handle members 6538 of FIGS.
132A-132B are generally cylindrical, as opposed to the generally rectangular
shape of the
handle members 6538 of FIGS. 129A-129C.
[00427] As shown in FIG. 132B, which is the same view as FIG. 132A, except
the
system is exploded to better illustrate its components, the anchor arm 115 is
contoured
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and curves along an arcuate path to provide axial alignment between a collar
165 and a
bore or other anchor member receiving features on the implant 25. The collar
165 is
configured to receive a sleeve 100 to cause the one or more anchor elements 30
to
extend through the ilium, the sacrum and the implant 25 generally transverse
to the
sacroiliac joint and implant 25, as described herein.
[00428] The anchor arm 115 is coupled to the implant arm 110 with a locking
member 6556. Specifically, as can be best understood from FIG. 132B, the
anchor arm
115 includes an engaging member 6568 configured to slidably couple with a
channel
6566 of the implant arm 110. The coupling arrangement may be achieved via a
dovetail
arrangement of the channel and pins received in holes of the coupling
arrangement.
Once the anchor arm 115 is coupled to the implant arm 110, a distal end 6572
of the
locking member 6556 is introduced through an opening 6570 to secure the anchor
arm
115 to the implant arm 110. To engage the implant 25, the retaining member
6548 is
introduced through an opening 6564 in the implant arm 110 such that a distal
end 6562 of
the retaining member 6548 may engage the implant 25, as described herein.
Finally, a
distal end 6558 of the impactor assembly 6550 may be introduced into an
opening 6560
on the implant arm 110 to couple the impactor assembly 6550 to the implant arm
110
such that displacing the impactor assembly 6550 causes the implant arm 110 to
deliver
the implant 25 to the joint region, as described herein. The handles 6538 are
removable
from the rest of the assembly.
[00429] For a detailed discussion of yet another of the system 10 for
fusing a
sacroiliac joint, reference is made to FIGS. 133A-133G. As can be understood
from FIGS.
133A, 133B, and 133E, an implant assembly includes the implant arm 110, an
elbow
6581, and a linear implant member 6580. The implant arm 110 has generally the
same
features as the implant arm 110 described above and have an implant removably
coupled
to a distal end of the implant arm via any of the above described
configurations, including
a retainer member 6548 (see FIG. 132B) extending through the implant arm. As
shown in
FIGS. 133A, 133B, and 133E, the implant arm 110 is coupled to the linear
implant
member 6580 via the elbow 6581. Specifically, the linear implant member 6580
and the
implant arm 110 intersect at the elbow 6581 such that the implant arm 110 and
the linear
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implant member 6580 are positioned at an angle relative to each other. The
elbow 6581
may serve as an impactor area for being impacted by an impactor in driving the
implant
supported on the end of the implant arm into the joint. The linear implant
member 6580 is
removably coupled to the arm assembly 85 at the anchor arm 115. In other
words, the
linear implant member 6580 is inserted into or otherwise couple to the anchor
arm 115
and secured with the locking member 6556.
[00430] The anchor arm 115 is coupled to a linear arm member 6578, which is
coupled to an arcuate arm member 6576. In one embodiment, the linear arm
member
6578 is generally parallel with the linear implant member 6580 and the arcuate
arm
member is generally parallel with the anchor arm 115. The arcuate arm member
6576 is
contoured and curves along an arcuate path to provide axial alignment between
collars
165 and a bore or other anchor member receiving features on the implant 25.
The collars
165 are each configured to receive a sleeve 100 to cause the one or more
anchor
elements 30 to extend through the ilium, the sacrum and the implant 25
generally
transverse to the sacroiliac joint and implant 25, as described herein.
[00431] As indicated in FIG. 133A by dimension line R, the arcuate arm
member
6576 may have a curvature with a radius of between approximately 120 mm and
approximately 180 mm with an arcuate length between the arrow ends of
dimension line
R of between approximately 200 mm and approximately 400 mm. As shown in FIG.
133B,
the U-shaped linear arm member 6578 of the anchor arm 115 extending from the
proximal end of the arcuate arm member 6576 and leading to the proximal end of
the
implant arm 110 has a distal linear segment with a length L1 of approximately
145 mm, a
middle linear segment with a with a length L2 of between approximately 50 mm
and
approximately 80 mm, and a proximal linear segment with a length L3 of between
approximately 95 mm and approximately 145 mm.
[00432] To illustrate the methodology associated with employing the
delivery tool 20
of FIGS. 133A, 133B, and 133E in implanting any of the above-described
implants 25 in
the sacroiliac joint 1000 of a patient 1001, reference is made to FIGS. 133C,
133D, 133F
and 133G. Specifically, FIGS. 1330 and 133F show the same tool orientations as
FIGS.
133B and 133E, respectively, except the system 10 is inserted through the soft
tissue
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1003 of the hip region 1002 of the patient 1001. FIG. 133D is the same view as
FIG. 1330,
except the soft tissue is hidden to show the patient bone structure. FIG. 133G
is the same
view as FIG. 133F, except the soft tissue is hidden to show the patient bone
structure.
[00433] As can be understood from FIGS. 1330 and 133F, the curvature and
relative positions of the features of the implant assembly and the arm
assembly mirror the
shape of the hip region 1002 to simplify surgery and increase reliability of
alignment.
Further, the system 10 is relatively compact such that it does not hinder
movement during
an operation. Also, the implant 25 may be inserted into the sacroiliac joint
via the implant
arm 110 via the approach discussed in detail with respect to FIGS. 103A-108A,
the main
difference being that the arcuate arm member 6576 is contoured and curves
along an
arcuate path to provide axial alignment between multiple collars 165 and a
bore or other
anchor member receiving features on the implant 25.
[00434] The embodiment of FIGS. 133A-133G can be used for other surgical
approaches such as, for example, the approaches illustrated in FIGS. 111A-
112C. For
example, for the approach shown in FIGS. 111A-111C, it may be preferred to
employ the
45 degree collar of the anchor arm 115, while for the approach depicted FIGS.
112A-112D, it may be preferred to employ the 90 degree collar of the anchor
arm 115 (i.e.,
the sleeve 100 that is generally perpendicular to the longitudinal axis of the
implant arm
110 and the implant 25 supported off of the implant arm.
[00435] The embodiment depicted in FIGS. 133A-133G offers a number of
advantages. First, this embodiment provides more grasping area for the medical
professional employing the device and allows for the hand and other body parts
of the
medical professional to be further from the x-ray beam of the fluoroscope.
Also, the
embodiment provides for increased visualization of the surgical site by the
medical
professional. Portions of the device, for example, 6578 are out of the area
being x-rayed
for fluro visualization, increasing the visualization possible via
fluoroscopy. Finally,
clamps can be employed on the device that can be used to secure the device to
a surgical
table out of the way of the x-ray beam or the imaging equipment.
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[00436] For a detailed discussion of an embodiment of a system 6583 for
extracting
an implant, reference is made to FIGS. 134A-134E. As can be understood from
FIG.
134A, the system 6583 includes a handle 90 and an implant retainer 95, which
have
features substantially similar to the handle 90 and implant retainer 95
described herein,
for example, with respect to FIG. 3. Further, the system 6583 includes a
distal end 6584
having a hook 6586, which is adapted to engage with an engaging portion 6588
of the
implant 25.
[00437] In one embodiment, as can be understood from FIGS. 129A-129C (and
in a
similar fashion from FIGS. 131A-131C, and 133A, 133B and 133E for other
embodiments), a sacroiliac joint fusion system 10 includes a joint implant 25,
an anchor
element 30 and a delivery tool 20. The joint implant includes a distal end 42
and a
proximal end 43 opposite the distal end. The anchor element comprising a
distal end and
a proximal end. The delivery tool includes an implant arm 110 and an anchor
arm 115.
The implant arm includes a proximal end and a distal end. The implant arm
distal end is
configured to releasably couple to the proximal end of the joint implant. The
anchor arm
includes a proximal end, a distal end, a header 6539 and a member 100. The
proximal
end of the anchor arm is coupled to the implant arm, and the header is
supported on the
anchor arm near the distal end of the anchor arm. The header includes at least
first and
second guide holes (e.g., any two or more of guide holes 165e-1651). The first
guide hole
(e.g., anyone of guide holes 165e-1651) is configured to orient the member 100
when
received in the first guide hole in a first approach aimed at least in the
vicinity of the joint
implant 25 when the proximal end 43 of the joint implant is releasably coupled
to the distal
end of the implant arm 110. Similarly, the second guide hole (e.g., any one of
guide holes
165e-1651 other than the first guide hole) is configured to orient the member
when
received in the second guide hole in a second approach aimed at least in the
vicinity of
the joint implant 25 when the proximal end 43 of the joint implant is
releasably coupled to
the distal end of the implant arm 110. The first and second approaches are
different. The
member 100 is configured to guide the delivery of the anchor element 30 to at
least in the
vicinity of the joint implant 25 when the proximal end 43 of the joint implant
is releasably
coupled to the distal end of the implant arm 110.
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[00438] Depending on the embodiment, the joint implant 25 includes a body
45
extending between the distal and proximal ends 42, 43 of the joint implant 25
and an
anchor hole 40 extends through the body non-parallel to a longitudinal axis of
the joint
implant. The first approach is aimed so as to cause the member 100 when
received in the
first guide hole to guide the anchor element 30 into the anchor hole. A
longitudinal axis of
the implant arm 110 may be substantially at least one of coaxial or parallel
with the
longitudinal axis of the joint implant 25.
[00439] The header 6539 may include a first arm 6544 that generally exists
in a
plane defined by at least portions of the implant arm 110 and the anchor arm
115. The
first and second guide holes 165f, 1651 are spaced apart from each other along
the first
arm and the respective first and second approaches are non-parallel to each
other.
[00440] The header 6539 may include a first arm 6540 or 6542 that generally
exists
in a plane generally perpendicular to a plane defined by at least portions of
the implant
arm 110 and the anchor arm 115. The first and second guide holes (e.g., any
two of
165e-165i or 165j-165k, depending on which arm 6540, 6542) are spaced apart
from
each other along the first arm and the respective first and second approaches
are
non-parallel to each other.
[00441] The header 6539 may include a first arm 6544 and a second arm 6540
or
6542. The first arm generally exists in a first plane defined by at least
portions of the
implant arm 110 and the anchor arm 115. The second arm generally exists in a
second
plane generally perpendicular to the first plane. The first guide hole (e.g.,
any one of 165f
or 1651) is located on the first arm and the second guide hole (e.g., any one
of 165e-165i
or 165j-165k, depending on which arm 6540, 6542) is located on the second arm.
In such
an embodiment, the first and second approaches are substantially parallel to
each other
(e.g., where the first and second guide holes are 165f and 165e) or the first
and second
approaches are non-parallel to each other (e.g., where the first and second
guide holes
are 1651 and 165h).
[00442] In one embodiment, as can be understood from FIGS. 129D-129K, the
joint
implant 25 includes a distal end 42, a proximal end 43, and a body 6579
extending
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between the distal and proximal ends. An anchor hole 40 extends through the
body
non-parallel to a longitudinal axis of the joint implant. A first planar
member 6581 extends
generally perpendicular to a first lateral edge of the body 6579 of the joint
implant 25, and
a second planar member 6580 extends generally perpendicular to a second
lateral edge
of the body of the joint implant opposite the first lateral edge. The body
6579 is
substantially a planar member. The first planar member 6581 is larger in at
least one of
length or width than the second planar member 6580.
[00443] As can be understood from FIGS. 131F-131I, in one embodiment, the
body
45 may be generally hollow and include a hollow open-ended insert 5777 that
substantially occupies in a generally mating manner the hollow body. The
insert is
removable from the body. The insert may include textured interior wall
surfaces. The
interior wall surfaces define a hollow interior of the insert. The insert may
be separate
from the distal end of the implant arm 110 or may be an extension of the
implant arm.
[00444] As will be appreciated from FIGS. 134B-1340, which show enlarged
views
of the distal end 6584 of the system of FIG. 134A, wherein the distal end 6584
is
decoupled and coupled to the implant, respectively, the handle 90 may displace
longitudinally to advance the distal end 6584 towards the implant 25. As best
shown in
FIGS. 132B, 134C and 134D, the hook 6586 may have angular features to form a
general
"L-shape." As can be understood from FIG. 134D and FIG. 134F, which is an
isometric
view of the proximal end of the implant of FIGS. 134B-134C, the proximal end
43 of the
implant has a central opening 70 which has an elongated section 70A extending
radially
outward from a centerline of the central opening 70. The elongated section 70A
transitions to a side opening 70B that is a transverse radial extension of the
central
opening that daylights at the surface of a wing portion 50 of the implant 25.
[00445] The hook 6586 may engage the implant 25 by entering the opening 70
in
the proximal end of the implant 25 such that the hook 6586 passes through the
elongated
section 70A and enters the side opening 70B to engage with an inner surface of
the
implant 25 in the engaging portion 6588. After the hook 6586 is coupled to the
engaging
portion 6588, the implant 25 may be extracted via repeatedly sliding the
handle along the
retainer 95 to cause the handle to repeatedly impact the cap 6599 of the
retainer 95.
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[00446] As can be understood from FIG. 134E, which is the same view as FIG.
134A,
except the system is exploded to better illustrate its components, the implant
retainer 95
and the handle 90 have substantially similar features to the handle 90 and the
implant
retainer 95 described herein, for example, with respect to FIG. 3, a main
difference being
that the shape of the handle 90 is contoured to fit into the palm of a user's
hand and the
handle is configured to slide along the retainer so as to allow impacting
against the cap
6599 to create a proximally directed impacting force that can be used to
extract the
implant from a sacroiliac joint. The implant retainer 95 is introduced through
the handle
90, as described herein, such that a distal end 6582 of the implant retainer
95 may be
coupled with a proximal end 6590 of the distal end 6584.
[00447] In one embodiment, as can be understood from FIGS. 134A-134E, the
extractor 6583 is configured to remove a joint implant 25 including a distal
end 42, a
proximal end 43 opposite the distal end, a body extending between the distal
and
proximal ends, and an opening 70 defined in the proximal end so as to define
an inward
edge 6591. The extractor 6583 includes a distal end 6584, a proximal end 6599,
a shaft
95 extending between the distal and proximal ends of the extractor, and a
handle 90
displaceable along the length of the shaft back and forth proximal-distal. The
shaft 95
includes a distal abutment 6593 and a proximal abutment 6599 respectively near
distal
and proximal ends of the shaft. The handle 90 is supported on the shaft 95
between the
distal and proximal abutments. The distal end 6584 of the extractor 6583
includes a
feature 6586 configured to engage the inward edge 6591 when the feature is
received in
the opening 70. The feature may be a hook or L-shaped.
[00448] As can be understood from FIGS. 134A-134E, and with continuing
reference to FIG. 126B, in one embodiment, an anchor 40 can be configured as a
cable
with an end that is able to be received in side opening 70B and further
configured to allow
a setscrew that may be advanced down central opening 70 (and with abutting
elements
received in 70A) to abut the cable end so as to anchor the cable end within
implant 25.
The other end of the cable can pass through the plane of the sacroiliac joint
and
communicate with components of a pelvic or spinal fixation system.
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[00449] For a discussion of an embodiment of the implant 25 that is
configured to
have a shape that generally mimics and even substantially fills a sacroiliac
joint space,
reference is made to FIGS. 135A-1350. As can be understood from a comparison
of the
side view of the implant 25 as illustrated in FIG. 135C to the shape of the
sacroiliac joint
articular region 1044 depicted in FIG. 106B, the implant has an overall
exterior shape that
generally mimics the sacroiliac joint articular region 1044. The anatomic
implant 25 can
be provided from the manufacturer in the configuration generally as shown in
the FIGS.
135A-1350 or assembled or deployed in situ from multiple pieces, as discussed
in further
detail below. As illustrated in FIGS. 135A-1350, the implant 25 includes a
proximal end
43 for being removably coupled to the extreme distal end of an implant arm of
any of the
above described delivery devices 20. The implant proximal end 43 includes
grooves
6514 and holes 75 that interface and couple with members 140 and 150 on the
implant
arm 110 similar to those described above with respect to FIG. 124D and FIG.
19,
respectively.
[00450] The implant 25 includes a long portion 7100 and a short portion
7101
perpendicularly oriented to the long portion. The long portion transitions
smoothly into the
short portion via a small radius 7102 and a large radius 7103 opposite the
small radius.
The large radius and small radius form an elbow region 7104 of the implant.
The large
radius forms a heal region 7105 of the implant, and opposite the heal region
is a blunt toe
region 7106 forming a right angle with a base region 7107 that is generally
parallel to the
proximal end 43. These regions 7105-7107 form the distal end 42 of the implant
25.
[00451] The implant 25 can be configured similar to previously described
implant
embodiments wherein the body of the implant is a generally continuous solid
surface with
one or more bores 40 defined therein. However, as indicated in FIGS. 135A-
1350, the
implant 25 may have a skeletonized configuration, wherein the is an outside
frame
boundary 7110 that extends unbroken and unitary through all of the above-
mentioned
regions of the implant, thereby forming it outer boundary while the interior
of the implant is
generally open space across which support members 7112 extend to join the
outside
frame boundary 7110 at different locations. As a result of its open
configuration, one or
more anchors 30 may be extended through the implant when implanted in the
sacroiliac
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joint. When implanted via the approach depicted in FIGS. 103A-108B, it can be
understood that the shape of the implant 25 of FIGS. 135A-135C may at least
somewhat
resemble the sacroiliac joint space and more fully occupy the joint space than
some of the
more linearly shaped rectangle and cylindrical implant embodiments described
above.
[00452] As can be understood from FIGS. 135A-1350, in one embodiment, a
sacroiliac joint fusion implant 25 includes a proximal end 43, a distal end 42
generally
opposite the proximal end, and first and second lateral sides 7117, 7118
extending
between the proximal and distal ends and defining a long portion of the
implant 7100 and
a short portion 7107 of the implant. The long portion is longer than the short
portion and
the two portions extend in directions generally perpendicular to each other.
The proximal
end terminates proximally in a generally blunt end 7119 and the distal end
terminates
distally in a generally blunt end 7106 facing in a direction generally
perpendicular of the
direction faced by the generally blunt end of the proximal end. The generally
blunt end of
the proximal end is configured to releaseably couple to an implant delivery
system. The
region of the implant between the lateral sides is open except for at least
one cross
member 7112 extending between the lateral sides 7117, 7118. An offset distance
between the lateral sides is substantially greater than a thickness of the
implant. The first
lateral side 7118 transitions between the long and short portions 7100, 7101
via a first
curved portion 7103 and the second lateral side 7117 transitions between the
long and
short portions via a second curved portion 7102 having a radius smaller than
the first
curved portion. The first and second lateral sides define a shape resembling a
shape of
an adult human sacroiliac joint as viewed in a direction perpendicular a plane
of the
sacroiliac joint. For example, the first and second lateral sides define a
shape resembling
a boot for a human foot.
[00453] For a discussion of an embodiment of the implant 25 that is
configured to
have a shape that generally mimics and even substantially fills a sacroiliac
joint space
after in situ deployment of certain components of the implant 25, reference is
made to
FIGS. 136A-136J. As shown in FIGS. 136A-136B and 136F-136I, in one embodiment,
the implant 25 includes a distal or leading end 42, a proximal or trailing end
43, a
longitudinally extending body 45, a rectangular void 7540 extending through
the body,
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and keels, fins or planar members 50, 55 that radially extend outwardly away
from the
body 45. In one embodiment, the radially extending planar members 50, 55 may
be
grouped into pairs of planar members 50, 55 that are generally coplanar with
each other.
For example, planar members 50 that are opposite the body 45 from each other
generally
exist in the same plane. More specifically, as best understood from FIGS. 136F
and
136G, the planar faces 60 of a first planar member 50 are generally coplanar
with the
planar faces 60 of a second planar member 50 opposite the body 45 from the
first planar
member 50. Likewise, the planar faces 65 of a third planar member 55 are
generally
coplanar with the planar faces 65 of a fourth planar member 55 opposite the
body 45 from
the third planar member 55. The body 45 may be a distinct central portion of
the implant
or may simply be an intersection of the four planar members 50, 55.
[00454] As best understood from FIGS. 136F and 136G, one set of planar
members
50 (i.e., the large planar members 50) may extend radially a greater distance
than the
distance extended radially by the other set of planar members 55 (i.e., the
small planar
members 55). Also, the width of a large planar member 50 from its outer edge
to its
intersection with the body 45 may be greater than the width of a small planar
member 55
from its outer edge to its intersection with the body 45. Also, the thickness
of the large
planar members 50 may be greater than the thickness of the small planar
members 55.
Thus, one set of planar members 50 may be both wider and thicker than the
other set of
planar members 55. In other words, one set of planar members 50 may be larger
than the
other set of planar members 55.
[00455] As can be understood from FIGS. 136A-1360, a toe member 7541 having
a
square or rectangular boxed shape is supported in the implant body 45 near the
distal end
42. The toe member 7541 is moveably supported on rails 7542 relative to the
rest of the
implant and can be caused to move perpendicularly to the longitudinal axis of
the implant
25 from a recessed location in the implant to a position that causes the toe
member 7541
to project past the extreme edge face of one of the large planar members 50
such that the
implant changes from having a rectangular box-like configuration to a boot or
L-shaped
configuration.
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[00456] As can be understood from FIGS. 136E and 136J, the toe member 7541
includes slots 7543 that matingly engage with the rails 7542 such that the
slots can slide
along the rails. A fluid conduit 7545 extends from the proximal end 43 to a
cylinder
housing 7546 in which a piston 7547 of the toe member is displaceably
received. An
0-ring 7548 seals the interface between the cylinder inner wall and the outer
circumferential piston surface. A pressurized fluid applied to the piston 7547
via the fluid
conduit 7545 causes the toe member 7541 to move out of the rest of the implant
so as to
project laterally from the rest of the implant as indicated in FIGS. 136C-
136D.
[00457] As illustrated in FIG. 136J and more clearly in FIGS. 136K and
136L, which
are respective enlarged views of the upper and lower cylinder regions of FIG.
136J, a lip
10050 defined in the upper end of the cylinder housing 7546 and a lip 10051
defined in
the lower end of the piston 7547 interact to provide an extreme limit to outer
movement of
the toe member 7541. Thus, the lips acts as stops to prevent the toe member
from
extending off of the rest of the implant due to over extension of the piston
in the cylinder.
[00458] While the deployment mechanism depicted in FIGS. 136E and 136J
accomplishes the deployment of the toe member 7541 hydraulic or pneumatic
lifting
mechanism, in other embodiments the deployment mechanism may be via a screw or
gear arrangement (e.g., spur, helical, rack, bevel, miter, worm, ratchet or
pawl gears).
Additionally, locking mechanisms may be employed to prevent backward movement
of
the toe member after deployment.
[00459] As can be understood from FIGS. 136A-136J, in one embodiment, the
sacroiliac joint fusion implant 25 includes a proximal end 43, a distal end 42
generally
opposite the proximal end, first and second lateral sides 50, 50 extending
between the
proximal and distal ends, and a member 7541 near the distal end configured to
displace
from a first position to a second position. As indicated in FIGS. 136A-136B,
the first
position may be such that the member 7541 is generally recessed within the
implant 25
such that a lateral side surface of the member is generally flush with the
first lateral side
50. As shown in FIGS. 1360-136D, the second position may be such that the
member
7541 extends from the first lateral side 50, the lateral side surface of the
member being
offset from and generally parallel to the first lateral side. The member 7541
may be
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displaceably supported on the implant via a rail arrangement 7542, 7543. As
indicated in
FIGS. 136E and 136J, the implant 25 may be in the form of an actuation
mechanism that
drives the member from the first position to the second position and is
actuatable via an
access at the proximal end. For example, the actuation mechanism may include a
hydraulic, pneumatic, geared or screwed mechanical arrangement.
[00460] For a discussion of an embodiment of the implant 25 that is
configured to
have a shape that generally mimics and even substantially fills a portion of a
sacroiliac
joint space, reference is made to FIGS. 137A-137F. As can be understood from a
comparison of the top plan view of the implant 25 as illustrated in FIG. 137C
to the shape
of the sacroiliac joint extra-articular region 3007 depicted in FIG. 106B, the
implant has an
overall exterior shape that generally mimics the sacroiliac joint extra-
articular region 3007.
The implant has a generally isosceles triangle shape in the top plan view. The
implant 25
includes a generally truncated, flat proximal end 43 from which two tapering
lateral sides
8331 extend and converge at the distal end 42, which forms a rounded or
arcuate distal
point. A void 7540 of a shape generally the same as the outer shape of the
implant itself
is defined in the body of the implant generally centered in the implant. The
top and bottom
surfaces 8332 of the implant have a serrated surface with edges oriented
proximally so as
to prevent proximal self-migration of the implant once implanted in the joint.
The serrated
edges extend parallel to the truncated, flat proximal end 43. One or more
anchors can be
extended through the void 7540 or a bone growth material can be located in the
void
7540.
[00461] FIGS. 138A-138F illustrate another embodiment the implant 25 that
is
configured to have a shape that generally mimics and even substantially fills
a portion of a
sacroiliac joint space. A comparison of the embodiment of FIGS. 138A-138F to
the
embodiment of FIGS. 137A-137F reveals that the embodiments are substantially
similar
except the embodiment of FIGS. 138A-138F has a flat, truncated distal end 42
as
opposed to an arcuate end, and the void 7540 is generally a circular bore as
opposed to a
shape that is generally triangular like the exterior boundaries of the
implant. As can be
understood from FIGS. 1380 and 138D, the bore 7540 does not extend completely
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perpendicular between the opposed top and bottom faces 7540, but instead has a
slight
cant or tilt.
[00462] As an example, due to idiopathic anatomic (e.g., skeletal or
neurovascular)
variations of certain patients it may be advantageous to have a custom
implant, anchor,
alignment tool or targeting arm manufactured for a particular individual. Pre-
surgical
imaging studies (e.g., CT or MRI) may be performed and post-processing,
including 3D
rendering, may assist in planning desired anchor trajectories, anchor
dimensions or
implant dimensions. The result of these studies and their interpretation may
provide
details specific to the manufacture of particular tools or implants and their
implantation.
[00463] As can be understood from the foregoing, various embodiments of the
delivery tools or system configurations as described herein can be similarly
configured to
operate with various embodiments of the sacroiliac joint implants disclosed in
US
Provisional 61/520,956.
[00464] In summary and as can be understood from the preceding discussion,
the
sacroiliac joint fusion systems 10 disclosed herein include a joint implant
25, an anchor
element 30 and a delivery tool 20. The joint implant 25 includes a
longitudinal axis CA
(e.g., see FIG. 10) and a bore 40 extending non-parallel to the longitudinal
axis CA. The
anchor element 30 is configured to be received in the bore 40.
[00465] The delivery tool 20 includes an implant arm 110 and an anchor arm
115.
The implant arm 110 is configured to releasably couple to the joint implant
25. The
anchor arm 115 is coupled to the implant arm and configured to deliver the
anchor
element 30 to the bore 40.
[00466] The final manufactured configuration of the tool 20 and final
manufactured
configuration of the joint implant 25 are such that, when the system 10 is
assembled such
that the implant arm 110 is releasably coupled to the joint implant 25 (e.g.,
as shown in
FIGS. 2A, 21A, 21C, 32, 37 and 109), a delivery arrangement automatically
exists such
that the anchor arm 115 is correctly oriented to deliver the anchor element 30
to the bore
40. Thus, when the system 10 is shipped from the manufacturer to the medical
facility
where the sacroiliac joint fusion will take place, the components 20, 25, 30,
40, 110, 115
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are each configured such that simply plugging them together such that the tool
20 is fully
assembled and the implant 25 is supported off of the distal end of the tool 20
is all that is
required to employ the tool 20 to both deliver the implant 25 into the
sacroiliac joint 1000
and deliver the anchor element 30 into the bore 40 so as to anchor the implant
25 in the
sacroiliac joint. In other words, once the components of the system 10 are
coupled
together, the cumulative result of the as-manufactured three dimensional
configurations
of each component of the system 10 is that the system 10 has a delivery
arrangement
such that the anchor arm 115 is correctly oriented to deliver the anchor
element 30 to the
bore 40 without having to adjust the as-manufactured three dimensional
configurations of
any of the components of the system 10. This automatically arrived-at delivery
arrangement is even the case wherein the anchor arm 115 being employed is part
of a
plurality of anchor arms (as discussed with respect to FIG. 21B ) or where the
anchor arm
115 is pivotally coupled to the implant arm 110 and further equipped with an
arcuate slider
105 at a free distal end of the anchor arm, the arcuate radius of the anchor
arm 115 at the
arcuate slider 105 being such that the radius extends through the bore 40 (as
discussed
with respect to FIG. 34).
[00467] While the implant embodiment of FIGS. 5-17 and many of the other
implant
embodiments described herein depict the bore 40 as being defined in the
implant body 45
such that the longitudinal axis of the bore 40 and the longitudinal axis of
the implant body
45 are coincident, in other embodiments, the bore 40 may be defined elsewhere
in the
implant 25. For example the bore 40 may be defined in the implant body 45 such
that the
longitudinal axes of the bore and implant body are offset from each other. As
another such example, the bore 40 may even be defined to extend across a wing
50, 55
so as to daylight at opposed planar surfaces 60 of a large wing 50 or the
opposed planar
surfaces 65 of a small wing 55.
[00468] In some embodiments, the distal end 35 of the delivery tool 20 may
be
removable so as to allow interchanging of different sized or shaped distal
ends 35 to allow
matching to particular implant embodiments without requiring the use of a
different
delivery tool 20 and while maintaining the alignment between components (e.g.,
anchor
30 aligned with bore 40) For example, as shown in FIGS. 139A and 139B, implant
arm
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1 10 includes a distal end 120 which includes large planar members, keels, or
fins 140 and
small planar members, keels, or fins 145. An adaptor 250 includes an opening
251
having notches 252 to receive fins 140 of the implant arm 110 and notches 253
to receive
fins 145 of the implant arm 110. Adaptor 250 also includes wings 255, which
may match
the relative shape and size of the channels 6514 of the implant 25. As further
shown in
FIGS. 139C-139F, central cylindrical member 220 of a retaining member is
received in
the proximal opening to retain the implant 25 securely on the distal end 120
of the implant
arm 110. The central cylindrical member 220 may include helical threading to
secure
implant 25. Looking at adaptor 250 in more detail at FIGS. 139G and 139H,
adaptor 250
has a first face 256 and a second face 257. The first face 256 has the wings
255
protruding from it such that, when the device is assembled, the first face 256
abuts the
implant 25 and the wings 255 engages the channels 6514 of the implant 25. The
second
face 257 has the opening 251 that includes the notches 252, 253. Within the
notches 253
are the grooves 259 shaped to receive the tabs 146 of the fins 145 of the
implant arm 110.
Fins 140, 145 fit into the opening 251 when the device is assembled. Adaptor
250 also
includes a hole 254, which traverses from the first face 256 to the second
face 257. The
hole 254 may match the relative size and shape of the diameter of the central
cylindrical
member 220. In some embodiments, when the central cylindrical member 220 is
not
extended through the implant arm 110, the fins 145 may bias inward. In this
embodiment,
upon insertion of the central cylindrical member 220 into the implant arm 110,
the fins 145
bias outward, thus connecting the tabs 146 with the grooves 259 in the notches
253 of the
opening 251 on the adaptor 250. The outward biasing of the fins 145 into the
grooves 259
secures the adaptor 250 to the implant arm 110. In one embodiment, the fins
140 also
bias in the same manner as fins 145.
[00469] Any of the implant embodiments disclosed herein may be configured
to be
delivered into the sacroiliac joint via being gripped and inserted by an
hemostat or similar
gripping device. For example, in one embodiment, as can be understood from
FIG. 21A,
the implant arm 110 is replaced with a hemostat or other pliers type
configuration that
grips the implant in a predictable and repeatable fashion. In a manner similar
to the
anchor arm 115 extending off of the implant arm 110 as depicted in FIG. 21A,
the anchor
arm 115 extends off of the hemostat to allow for the guided delivery of the
anchor 30 into
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the anchor hole 40 of the implant 25 when the implant 25 is supported off of
the gripping
aspect of the hemostat. The anchor 30 is aligned with the anchor hole 40 in a
manner as
described above with respect to FIG. 21A, except the implant arm 110 is a
hemostat type
gripping configuration instead of a tubular body of the implant arm 110 of
FIG. 21A. The
rest of the device 10, including the anchor arm 115 extending off of the
hemostat
configuration, is generally as shown in FIG. 21A.
[00470] Any of the implants and delivery systems disclosed herein may be
employed to treat a variety of joints, bone fractures and/or bone fragments
and should not
be limited to treatment of the sacroiliac joint.
[00471] The foregoing merely illustrates the principles of the invention.
Various
modifications and alterations to the described embodiments will be apparent to
those
skilled in the art in view of the teachings herein. It will thus be
appreciated that those
skilled in the art will be able to devise numerous systems, arrangements and
methods
which, although not explicitly shown or described herein, embody the
principles of the
invention and are thus within the spirit and scope of the present invention.
From the
above description and drawings, it will be understood by those of ordinary
skill in the art
that the particular embodiments shown and described are for purposes of
illustrations
only and are not intended to limit the scope of the present invention.
References to
details of particular embodiments are not intended to limit the scope of the
invention.
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