Note: Descriptions are shown in the official language in which they were submitted.
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METHOD AND APPARATUS FOR CLOSING A FISSURE IN THE
ANNULUS OF AN INTERVERTEBRAL DISC
10
Reference To Pending Prior Patent Applications
This patent application:
(1) is a continuation-in-part of pending prior U.S. Patent Application
Serial No. 14/461,992, filed 08/18/2014 by Suture Concepts Inc. and Peter
Sorensen et al. for METHOD AND APPARATUS FOR CLOSING A FISSURE
IN THE ANNULUS OF AN INTERVERTEBRAL DISC, AND/OR FOR
EFFECTING OTHER ANATOMICAL REPAIRS AND/OR FIXATIONS
(Attorney's Docket No. SUTURECONCEPTS-010203), which patent application
in turn:
(i) claims benefit of prior U.S. Provisional Patent Application
Serial No. 61/866,955, filed 08/16/2013 by Suture Concepts Inc. and Peter
Sorensen et al. for METHOD AND APPARATUS FOR CLOSING A FISSURE
IN THE ANNULUS OF AN INTERVERTEBRAL DISC, AND/OR FOR
EFFECTING OTHER ANATOMICAL REPAIRS AND/OR FIXATIONS
(Attorney's Docket No. SUTURECONCEPTS-1 PROV);
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(ii) claims benefit of prior U.S. Provisional Patent Application
Serial No. 61/915,433, filed 12/12/2013 by Suture Concepts Inc. and Peter
Sorensen et al. for METHOD AND APPARATUS FOR CLOSING A FISSURE
IN THE ANNULUS OF AN INTERVERTEBRAL DISC, AND/OR FOR
EFFECTING OTHER ANATOMICAL REPAIRS AND/OR FIXATIONS
(Attorney's Docket No. SUTURECONCEPTS-2 PROV);
(iii) claims benefit of prior U.S. Provisional Patent Application
Serial No. 61/984,431, filed 04/25/2014 by Suture Concepts Inc. and Peter
Sorensen et al. for METHOD AND APPARATUS FOR CLOSING A FISSURE
IN THE ANNULUS OF AN INTERVERTEBRAL DISC, AND/OR FOR
EFFECTING OTHER ANATOMICAL REPAIRS AND/OR FIXATIONS
(Attorney's Docket No. SUTURECONCEPTS-3 PROV); and
(iv) is a continuation-in-part of prior U.S. Patent Application Serial
No. 14/068,406, filed 10/31/2013 by Suture Concepts Inc. and Bret A. Ferree
for
METHOD AND APPARATUS FOR CLOSING FISSURES IN THE ANNULUS
FIBROSUS (Attorney's Docket No. ANOVA-BAF-24602/29), which in turn
claims benefit of:
(a) prior U.S. Provisional Patent Application Serial No.
61/720,593, filed 10/31/2012 by Bret A. Ferree for METHOD AND
APPARATUS FOR CLOSING FISSURES IN THE ANNULUS FIBROSUS
(Attorney's Docket No. ANOVA-BAF-24618/29); and
(2) claims benefit of pending prior U.S. Provisional Patent Application
Serial No. 62/427,879, filed 11/30/2016 by Suture Concepts Inc. and Peter
Sorensen et al. for METHOD AND APPARATUS FOR CLOSING A FISSURE
IN THE ANNULUS OF AN INTERVERTEBRAL DISC, AND/OR FOR
EFFECTING OTHER ANATOMICAL REPAIRS AND/OR FIXATIONS
(Attorney's Docket No. SUTURECONCEPTS-6 PROV) .
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The seven (7) above-identified patent applications are hereby incorporated
herein by reference.
Field Of The Invention
This invention relates to the treatment of degenerative disc disease in
general, and more particularly to methods and apparatus for closing fissures
in the
annulus of an intervertebral disc. This invention also relates to methods and
apparatus for effecting other anatomical repairs and/or fixations.
Background Of The Invention
The human spine is a column of articulating vertebrae separated by
intervertebral discs. It provides support for the torso, and houses and
protects the
spinal cord in its spinal canal.
The human intervertebral disc is an oval-shaped to kidney-shaped
structure of variable size depending on its location in the spine. The outer
portion
of the disc is known as the annulus fibrosus (or anulus fibrosus, annulus
fibrosis,
anulus fibrosis) or simply "the annulus". The inner portion of the disc is
known
as the nucleus pulposis or simply "the nucleus".
The annulus is made up of ten to twenty collagen fiber lamellae. The
2 0 collagen fibers within a given lamella extend parallel to one another.
Successive
lamellae have their collagen fibers oriented in alternating directions. About
48
percent of the lamellae are incomplete, but this percentage varies with
location
and it increases with age. On average, the collagen fibers of a given lamella
lie at
an angle of about sixty degrees to the vertebral axis line, but this too
varies with
location. The orientations of the lamellae serve to control vertebral motion
(i.e.,
one half of the lamellae tighten to check motion when the vertebra above or
below
the disc are turned in either direction).
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The annulus contains the nucleus. The nucleus has a consistency
generally similar to that of crabmeat. The nucleus serves to transmit and
dampen
axial loads. A high water content (approximately 70-80 percent) assists the
nucleus in this function. The water content has a diurnal variation. The
nucleus
absorbs water while a person lies recumbent. Activity generates increased
axial
loads which squeeze water from the disc. The nucleus comprises roughly 50
percent of the entire disc. The nucleus contains cells (chondrocytes and
fibrocytes) and proteoglycans (chondroitin sulfate and keratin sulfate). The
cell
density in the nucleus is on the order of 4,000 cells per microliter.
1 0 The intervertebral disc changes, or "degenerates", with age. As a
person
ages, the water content of the disc falls from approximately 85 percent at
birth to
approximately 70 percent in the elderly. The ratio of chondroitin sulfate to
keratin sulfate decreases with age, while the ratio of chondroitin 6 sulfate
to
chondroitin 4 sulfate increases with age. The distinction between the annulus
and
the nucleus decreases with age. Generally, disc degeneration is painless.
Premature or accelerated disc degeneration is known as degenerative disc
disease. A large portion of patients suffering from chronic lower back pain
are
thought to have this condition. As the disc degenerates, the nucleus and
annulus
functions are compromised. The nucleus becomes thinner and less able to handle
2 0 compressive loads. The annulus fibers become redundant as the nucleus
shrinks.
The redundant annular fibers are less effective in controlling vertebral
motion.
This disc pathology can result in (i) tears of the annulus (both "full-
thickness"
tears and "partial-thickness" tears) as abnormal loads are transmitted to the
annulus and the annulus is subjected to excessive motion between vertebrae,
and
(ii) disc herniation (i.e., extrusion of the nucleus) through complete (i.e.,
full-
thickness) annular tears. Degenerative disc disease is frequently the cause of
substantial pain for a patient.
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Current surgical treatments for disc degeneration are generally
"destructive", in the sense that they generally involve the removal or
destruction
of disc tissue.
One group of procedures, which includes microlumbar discectomy,
removes the nucleus or a portion of the nucleus.
A second group of procedures destroys nuclear material. This group
includes Chymopapin (an enzyme) injection, laser discectomy, and thermal
therapy (i.e., heat treatment to denature proteins in the nucleus).
The foregoing two groups of procedures compromise the nucleus of the
1 0 treated disc, and may exacerbate fissures in the annulus while
accessing the
nucleus.
A third group of procedures, which includes spinal fusion procedures,
either removes the disc or effectively eliminates the disc's function by
connecting
together two or more vertebrae, e.g., by "fusing" the vertebrae together with
bone.
However, such spinal fusion procedures transmit additional stress to the
adjacent
discs, which typically results in premature degeneration of the adjacent discs
over
time.
In general, the "destructive" nature of current surgical treatments for disc
degeneration can provide substantial pain relief for the patient, but it can
also lead
2 0 to further disc degeneration over time, which can result in new pain
for the
patient. By way of example but not limitation, procedures to remove the
nucleus
or a portion of the nucleus, and procedures to destroy nuclear material,
compromise nucleus function and may exacerbate fissures in the annulus while
accessing the nucleus, thereby leading to further disc degeneration. By way of
further example but not limitation, spinal fusion procedures can induce
premature
disc degeneration in adjacent intervertebral discs.
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Ideally, disc herniation (i.e., the extrusion of nucleus through full-
thickness annular tears) should be treated by closing the fissures in the
annulus.
However, in practice, this is difficult to achieve.
By way of example but not limitation, it is difficult to close fissures in the
annulus by conventional suturing. For one thing, the annulus is tough and
thick
and does not lend itself to manual suturing, particularly given the limited
access
corridors often imposed on the surgeon. For another thing, the loads imposed
on
the nucleus are large, so that inadequate closure of the fissures can lead to
subsequent recurrence of the fissures. Furthermore, the area surrounding the
intervertebral disc is crowded with delicate structures (e.g., nerves), so
that the
use of knots to secure suture can be problematic.
By way of further example but not limitation, it is difficult to close
fissures in the annulus using conventional toggle anchors. More particularly,
in
U.S. Patent No. 7,004,970, issued February 28, 2006 to Cauthen III et al.,
there is
disclosed a system for closing fissures in the annulus, wherein the system
comprises first and second conventional toggle anchors connected together by
filament, and wherein the filament comprises a cinch knot and a cinch line.
See,
for example, Figs. 61A, 61B, 62A-62D and 63 of Cauthen III et al. With this
system, the first conventional toggle anchor is passed through the annulus and
2 0 into the nucleus on a first side of a fissure, the second conventional
toggle anchor
is passed through the annulus and into the nucleus on a second side of the
fissure,
and then the cinch line is pulled to draw together the two conventional toggle
anchors and thereby close the fissure. However, this system suffers from
significant drawbacks. First, it is difficult to reliably toggle conventional
toggle
anchors within the nucleus, which can result in poor setting of the
conventional
toggle anchors within the intervertebral disc and hence inadequate closure of
the
fissure. Second, it is difficult to set the cinch knot close to the surface of
the
annulus, particularly given the limited access corridors often imposed on the
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surgeon, which can result in inadequate closure of the fissure and
interference
with the delicate structures around the intervertebral disc, e.g., nerves,
etc. Third,
the cinch knot can easily slip, thereby undermining the closure of the
fissure. For
this reason, systems using conventional toggle anchors have achieved limited
success in closing fissures within the annulus.
In Cauthen III et al., there is also disclosed a knotless system for
tensioning the filament between the two conventional toggle anchors, wherein
enlargements are formed on the filament and are pulled through a narrow
opening
formed on one of the conventional toggle anchors so as to provide a knotless
1 0 ratchet securement. However, this knotless ratchet securement is
limited to preset
tension levels (i.e., it is not continuously adjustable) and has limited
holding
power, among other things.
Thus there is a need for a new and improved method and apparatus for
closing fissures in the annulus of an intervertebral disc, whereby to treat
degenerative disc disease.
In addition to the foregoing, in many other situations it may be necessary
and/or desirable to effect anatomical repairs and/or fixations.
By way of example but not limitation, two pieces of soft tissue may need
to be held in apposition to one another to effect a repair (e.g., so as to
close an
2 0 incision in the skin), or two pieces of cartilage may need to be held
in apposition
to one another to effect a repair (e.g., so as to close a tear in meniscal
cartilage),
or two pieces of bone may need to be held in apposition to one another so as
to
effect a repair (e.g., so as to fuse together bone).
By way of further example but not limitation, a piece of soft tissue may
need to be held in apposition to bone to effect a repair (e.g., so as to
attach soft
tissue to bone), or a piece of cartilage may need to be held in apposition to
bone to
effect a repair (e.g., so as to attach labrum to bone or to attach meniscal
cartilage
to bone).
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By way of further example but not limitation, a prosthesis may need to be
held in apposition to soft tissue or bone, or soft tissue or bone may need to
be held
in apposition to a prosthesis, and/or any first object may need to be held in
apposition to any second object.
In these and other situations, it would also be advantageous to provide a
new and improved method and apparatus for effecting anatomical repairs and/or
fixations.
Summary Of The Invention
The present invention provides a new and improved method and apparatus
for closing fissures in the annulus of an intervertebral disc, whereby to
treat
degenerative disc disease.
The present invention also provides a new and improved method and
apparatus for effecting other anatomical repairs and/or fixations.
More particularly, among other things, the present invention facilitates the
reconstruction of the annulus by providing a novel method and apparatus for
closing fissures in the annulus of an intervertebral disc. Among other things,
such
reconstruction prevents recurrent herniation following a microlumbar
discectomy.
The invention may also be used in the treatment of herniated discs, annular
tears
2 0 of the disc, and/or other disc degeneration, while enabling surgeons to
preserve
(or even augment or replace) the contained nucleus. The method and apparatus
of
the present invention may be used to treat discs throughout the spine,
including
the cervical, thoracic, and lumbar spines of humans and animals.
Preferred embodiments of the present invention include a flexible
longitudinal fixation component (e.g., a filament) extending across a soft
tissue
defect, such as a fissure in the annulus. A pair of transverse anchor
components
(e.g., bar anchors), selectively connected to the flexible longitudinal
fixation
component, are preferably placed behind an inner layer of the annulus on
opposite
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sides of the fissure, so as to anchor the flexible longitudinal fixation
component to
the annulus, with the flexible longitudinal fixation component extending
axially
through the annulus and laterally across the fissure so as to hold the fissure
closed, whereby to prevent nucleus material from passing out the fissure and
pressing on the adjacent nerves, including the spinal cord. Significantly,
with the
present invention, the transverse anchor components can be passed through the
annulus and into the nucleus of the intervertebral disc using a direct "needle
plunge" action, which facilitates passage through the tough, thick annulus,
and
which is highly compatible with the limited access corridors often imposed on
the
1 0 surgeon. Furthermore, the present invention allows the tension of the
flexible
longitudinal fixation component to be adjusted as necessary so as to effect
proper
fissure closure, and then set in place without requiring the use of knots.
And the flexible longitudinal fixation component (e.g., the filament) may
be anchored to one of the upper and lower vertebral bodies adjacent to the
intervertebral disc being treated.
In one preferred form of the present invention, two novel transverse
anchor components (e.g., bar anchors) are provided. One novel anchor
component (sometimes hereinafter referred to as the distal anchor) is provided
with an associated inserter and the two, in conjunction with the flexible
longitudinal fixation component (e.g., filament) provide enhanced toggling of
the
anchor component within dense structures such as a vertebral body and/or an
intervertebral disc. The second novel anchor component (sometimes hereinafter
referred to as the proximal anchor) is provided with novel means for knotles
sly
securing the flexible longitudinal fixation component to that anchor
component,
whereby to allow the tension of the flexible longitudinal fixation component
to be
reliably set between the two anchor components without requiring the use of
knots.
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The present invention may also be used to effect other anatomical repairs
and/or fixations.
By way of example but not limitation, the present invention may be used
to hold two pieces of soft tissue in apposition to one another to effect a
repair
(e.g., so as to close an incision in the skin), or the present invention may
be used
to hold two pieces of cartilage in apposition to one another to effect a
repair (e.g.,
so as to close a tear in meniscal cartilage), or the present invention may be
used to
hold two pieces of bone in apposition to one another so as to effect a repair
(e.g.,
so as to fuse together bone).
By way of further example but not limitation, the present invention may
be used to hold a piece of soft tissue in apposition to bone to effect a
repair (e.g.,
so as to attach soft tissue to bone), or the present invention may be used to
hold a
piece of cartilage in apposition to bone to effect a repair (e.g., so as to
attach
labrum to bone or to attach meniscal cartilage to bone).
By way of further example but not limitation, the present invention may
be used to hold a prosthesis in apposition to soft tissue or bone, or to hold
soft
tissue or bone in apposition to a prosthesis, and/or to hold any first object
in
apposition to any second object.
In one preferred form of the present invention, there is provided apparatus
2 0 for attaching a first object to a second object, said apparatus
comprising:
a distal anchor comprising a generally cylindrical body, a distal end and a
proximal end, wherein said distal end comprises an inclined distal end
surface,
and a vertical bore extending through said generally cylindrical body,
perpendicular to the longitudinal axis of said generally cylindrical body;
a proximal anchor comprising a generally cylindrical body, a distal end
and a proximal end, a top surface and a bottom surface, a first vertical bore
extending through said generally cylindrical body from said top surface to
said
bottom surface, perpendicular to the longitudinal axis of the generally
cylindrical
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body, a second vertical bore spaced distally from said first vertical bore and
extending from said top surface to said bottom surface parallel to said first
vertical bore, a third vertical bore spaced distally from said second vertical
bore
and extending from said top surface to said bottom surface parallel to said
first
vertical bore, and a fourth vertical bore spaced distally from said third
vertical
bore and extending from said top surface to said bottom surface parallel to
said
first vertical bore; and
a suture having a proximal end and a distal end, with an enlargement
formed at said distal end, wherein said suture extends through said vertical
bore of
1 0 said distal anchor, through said fourth vertical bore of said proximal
anchor,
through said third vertical bore of said proximal anchor, through said second
vertical bore of said proximal anchor and through said first vertical bore of
said
proximal anchor.
In another preferred form of the present invention, there is provided a
method for connecting a first object to a second object, said method
comprising:
providing apparatus comprising:
a distal anchor comprising a generally cylindrical body, a distal
end and a proximal end, wherein said distal end comprises an inclined distal
end
surface, and a vertical bore extending through said generally cylindrical
body,
2 0 perpendicular to the longitudinal axis of said generally cylindrical
body;
a proximal anchor comprising a generally cylindrical body, a distal
end and a proximal end, a top surface and a bottom surface, a first vertical
bore
extending through said generally cylindrical body from said top surface to
said
bottom surface, perpendicular to the longitudinal axis of the generally
cylindrical
body, a second vertical bore spaced distally from said first vertical bore and
extending from said top surface to said bottom surface parallel to said first
vertical bore, a third vertical bore spaced distally from said second vertical
bore
and extending from said top surface to said bottom surface parallel to said
first
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vertical bore, and a fourth vertical bore spaced distally from said third
vertical
bore and extending from said top surface to said bottom surface parallel to
said
first vertical bore; and
a suture having a proximal end and a distal end, with an
enlargement formed at said distal end, wherein said suture extends through
said
vertical bore of said distal anchor, through said fourth vertical bore of said
proximal anchor, through said third vertical bore of said proximal anchor,
through
said second vertical bore of said proximal anchor and through said first
vertical
bore of said proximal anchor;
1 0 advancing said distal anchor into the first object, with said
suture and said
enlargement advancing with said distal anchor;
while holding said suture and said enlargement in place, further advancing
said distal anchor so that said inclined distal end surface of said distal
anchor
engages said enlargement and causes said distal anchor to turn relative to the
first
object;
advancing said proximal anchor into the second object;
pulling proximally on the portion of said suture extending between said
second vertical bore of said proximal anchor and said third vertical bore of
said
proximal anchor so as to cause said proximal anchor to turn relative to the
second
object;
passing said proximal end of said suture between (i) the portion of said
suture extending between said second vertical bore of said proximal anchor and
said third vertical bore of said proximal anchor and (ii) said proximal
anchor, so
as to form a half hitch in said suture; and
pulling proximally on said proximal end of said suture so as to set said
half hitch.
In another preferred form of the present invention, there is provided
apparatus for attaching a suture to an object, said apparatus comprising:
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an anchor comprising a generally cylindrical body, a distal end and a
proximal end, wherein said distal end comprises an inclined distal end
surface,
and a vertical bore extending through said generally cylindrical body,
perpendicular to the longitudinal axis of said generally cylindrical body; and
a suture having a proximal end and a distal end, with an enlargement
formed at said distal end, wherein said suture extends through said vertical
bore of
said anchor.
In another preferred form of the present invention, there is provided a
method for attaching a suture to an object, said method comprising:
providing apparatus comprising:
an anchor comprising a generally cylindrical body, a distal end and
a proximal end, wherein said distal end comprises an inclined distal end
surface,
and a vertical bore extending through said generally cylindrical body,
perpendicular to the longitudinal axis of said generally cylindrical body; and
a suture having a proximal end and a distal end, with an
enlargement formed at said distal end, wherein said suture extends through
said
vertical bore of said anchor;
advancing said anchor into said object, with said suture and said
enlargement advancing with said anchor;
2 0 while holding said suture and said enlargement in place, further
advancing
said anchor so that said inclined distal end surface of said anchor engages
said
enlargement and causes said anchor to turn relative to said object.
In another preferred form of the present invention, there is provided
apparatus for attaching a suture to an object, said apparatus comprising:
an anchor comprising a generally cylindrical body, a distal end and a
proximal end, a vertical bore extending through said generally cylindrical
body,
perpendicular to the longitudinal axis of said generally cylindrical body, a
recess
formed on one side of said generally cylindrical body and a U-shaped slot
formed
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on the opposing side of said generally cylindrical body whereby to form a
flexible
finger extending distally within said generally cylindrical body, and further
wherein said distal end of said finger is spaced from an opposing portion of
said
generally cylindrical body; and
a suture extending through said vertical bore, said recess and said U-
shaped slot.
In another preferred form of the present invention, there is provided a
method for attaching a suture to an object, said method comprising
providing apparatus comprising:
1 0 an anchor comprising a generally cylindrical body, a distal
end and
a proximal end, a vertical bore extending through said generally cylindrical
body,
perpendicular to the longitudinal axis of said generally cylindrical body, a
recess
formed on one side of said generally cylindrical body and a U-shaped slot
formed
on the opposing side of said generally cylindrical body whereby to form a
flexible
finger extending distally within said generally cylindrical body, and further
wherein said distal end of said finger is spaced from an opposing portion of
said
generally cylindrical body; and
a suture extending through said vertical bore, said recess and said
U-shaped slot;
2 0 advancing said anchor into the object; and
pulling on said proximal end of said suture.
In another preferred form of the present invention, there is provided
apparatus for attaching a suture to an object, said apparatus comprising:
an anchor comprising a body having a distal end and a proximal end, and a
vertical bore extending through said body substantially perpendicular to the
longitudinal axis of said body;
wherein said anchor further comprises a recess formed on one side of said
body and a U-shaped slot formed on the opposing side of said body, whereby to
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form a flexible finger extending distally within said body, and further
wherein
said distal end of said finger is spaced from an opposing portion of said
body; and
wherein at least one of said flexible finger and said body comprises a
cutout extending therethrough, with said cutout cooperating with said U-shaped
slot and said recess so as to together form a suture loading hole extending
through
said body, with said suture loading hole being sized to receive a suture
therein.
In another preferred form of the present invention, there is provided a
method for attaching a suture to an object, said method comprising
providing apparatus comprising:
an anchor comprising a body having a distal end and a proximal
end, and a vertical bore extending through said body substantially
perpendicular
to the longitudinal axis of said body;
wherein said anchor further comprises a recess formed on one side
of said body and a U-shaped slot formed on the opposing side of said body,
whereby to form a flexible finger extending distally within said body, and
further
wherein said distal end of said finger is spaced from an opposing portion of
said
body; and
wherein at least one of said flexible finger and said body comprises
a cutout extending therethrough, with said cutout cooperating with said U-
shaped
2 0 slot and said recess so as to together form a suture loading hole
extending through
said body, with said suture loading hole being sized to receive a suture
therein;
and
a suture comprising a proximal end and a distal end; and
passing said suture through said vertical bore of said anchor, forming a
loop, passing said suture back through said vertical bore of said anchor, and
passing said suture through said suture loading hole.
Brief Description Of The Drawings
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These and other objects and features of the present invention will be more
fully disclosed or rendered obvious by the following detailed description of
the
preferred embodiments of the invention, which is to be considered together
with
the accompanying drawings wherein like numbers refer to like parts, and
further
wherein:
Figs. 1 and 2 are schematic views showing a novel system for closing a
fissure in the annulus of an intervertebral disc, whereby to treat
degenerative disc
disease, and/or for effecting other anatomical repairs and/or fixations;
Fig. 3 is a schematic view showing the anchor assembly of the novel
system of Figs. land 2;
Fig. 4 is a schematic view showing the inserter of the novel system of
Figs. 1 and 2;
Figs. 5-25 are schematic views showing further details of the anchor
assembly of Fig. 3;
Figs. 26, 27, 27A and 28-31 are schematic views showing further details
of the inserter of Fig. 4;
Figs. 32-38 and 38A-38G are schematic views showing use of the novel
system of Figs. 1 and 2 to close a fissure in the annulus of an intervertebral
disc;
Figs. 39-41 are schematic views showing a tensioner which may be used
in conjunction with the novel system of Figs. 1 and 2;
Figs. 41A and 41B are schematic views showing another form of tensioner
which may be used in conjunction with the novel system of Figs. 1 and 2;
Figs. 42-51 are schematic views showing examples of additional
anatomical repairs and/or fixations which may be effected using the present
invention;
Fig. 52 is a schematic view showing a sensory nerve stimulator (SNS) lead
positioned within a spine;
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Figs. 53-62 are schematic views showing how the novel system may be
used to hold an SNS lead in position within anatomy;
Figs. 63-70 are schematic views showing various ways in which the novel
system may be used to secure an SNS lead adjacent to spinal structures;
Figs. 71 and 72 are schematic views showing a proximal anchor
comprising a flexible finger;
Fig. 73 is a schematic view showing a single anchor system formed in
accordance with the present invention;
Figs. 74-85 are schematic views showing another single anchor system
1 0 formed in accordance with the present invention, wherein the system
comprises
an anchor comprising a flexible finger;
Fig. 86 is a schematic view showing an alternative form of inserter with
impulse driver;
Figs. 87-92 are schematic views showing another single anchor system
formed in accordance with the present invention, wherein the system comprises
an anchor comprising a flexible finger;
Figs. 93-97 are schematic views showing another form of stop for
selectively preventing deployment of an anchor from an inserter; and
Fig. 98 is a schematic view showing yet another form of stop for
2 0 selectively preventing deployment of an anchor from an inserter.
Detailed Description Of The Preferred Embodiments
The present invention comprises the provision and use of a novel system
for closing a fissure in the annulus of an intervertebral disc, whereby to
treat
degenerative disc disease.
The present invention also provides a new and improved method and
apparatus for effecting other anatomical repairs and/or fixations.
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Novel System For Closing A Fissure In The Annulus
Of An Intervertebral Disc And/Or For Effecting
Other Anatomical Repairs And/Or Fixations
More particularly, and looking first at Figs. 1 and 2, there is shown a novel
system 5 for, among other things, closing a fissure in the annulus of an
intervertebral disc. System 5 generally comprises an anchor assembly 10 (Figs.
1-
3) and an inserter 15 (Figs. 1, 2 and 4).
Novel Anchor Assembly
Looking now at Figs. 3 and 5-8, anchor assembly 10 generally comprises a
distal anchor 20, a proximal anchor 25, and a suture 30 connecting distal
anchor
and proximal anchor 25.
Novel Distal Anchor
15 As seen in Figs. 5, 6 and 9-16, distal anchor 20 comprises a
generally
cylindrical body 35 having a distal end 40, a proximal end 45 and a generally
circular side wall 50. Distal end 40 terminates in a flat distal surface 55
and an
inclined distal surface 60. Flat distal surface 55 is preferably sufficiently
large to
render distal end 40 of distal anchor 20 substantially blunt. Inclined distal
surface
2 0 60 is pitched at an appropriate angle (e.g., 30 degrees, 45 degrees,
etc.) so as to
cause distal anchor 20 to turn during deployment, as will hereinafter be
discussed.
Proximal end 45 terminates in an inclined proximal surface 65. Inclined
proximal
surface 65 is pitched at an appropriate angle (e.g., 70 degrees) so as to
cause distal
anchor 20 to set during deployment, as will hereinafter be discussed. A
vertical
bore 70 passes through distal anchor 20. Vertical bore 70 is sized to slidably
receive suture 30 therein. A horizontal slot 75 extends between inclined
distal
end surface 60 and vertical bore 70. Horizontal slot 75 is preferably also
sized to
slidably receive suture 30 therein and helps keep distal anchor 20 and suture
30
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from binding when they are disposed within inserter 15. A pair of distal
notches
80 are preferably formed in distal end 40 and intersect inclined distal
surface 60.
A proximal notch 85 is preferably formed near to, but proximal to, proximal
end
surface 65. Proximal notch 85 cooperates with inclined proximal surface 65 to
form a pointed heel 87 which enhances setting of distal anchor 20, as will
hereinafter be discussed. In one preferred form of the invention, distal
anchor 20
is formed out of PEEK or carbon-filled PEEK, has a length of about 0.20 inch
and
a width of about 0.063 inch. However, it should be appreciated that distal
anchor
20 may also be formed out of other suitable materials and/or have other
dimensions.
Novel Proximal Anchor
As seen in Figs. 7, 8 and 17-25, proximal anchor 25 comprises a generally
cylindrical body 90 having a distal end 95, a proximal end 100 and a generally
circular side wall 105. Distal end 95 terminates in a flat distal surface 110
and an
inclined distal surface 115. Flat distal surface 110 is preferably
sufficiently large
to render distal end 95 of proximal anchor 25 substantially blunt. Inclined
distal
surface 115 is pitched at an appropriate angle (e.g., 30 degrees, 45 degrees,
etc.)
so as to assist proximal anchor 25 in turning during deployment, as will
2 0 hereinafter be discussed. Proximal end 100 terminates in an inclined
proximal
surface 120. Inclined proximal surface 120 is pitched at an appropriate angle
(e.g., 20 degrees from the vertical) so as to assist proximal anchor 25 in
setting
during deployment, as will hereinafter be discussed. Four vertical bores 125,
130,
135 and 140 pass through proximal anchor 25. Vertical bores 125, 130, 135 and
140 are sized to slidably receive suture 30 therein. A top horizontal slot 145
extends between vertical bores 130 and 135. Top horizontal slot 145 is
preferably
also sized to slidably receive suture 30 therein and helps keep proximal
anchor 25
and suture 30 from binding when they are disposed within inserter 15. A bottom
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horizontal slot 150 extends between vertical bores 125 and 130. If desired,
bottom horizontal slot 150 may be stepped, and may comprise a wider outer
portion 155 and a narrower inner portion 160. Wider outer portion 155 may be
sized to slidingly receive suture 30 therein so as to help keep proximal
anchor 25
and suture 30 from binding when they are disposed within inserter 15, but
narrower inner portion 160 may be sized to snugly receive suture 30 therein,
whereby to provide a light hold on suture 30 when suture 30 is disposed
therein.
A bottom horizontal slot 165 extends between vertical bores 135 and 140. If
desired, bottom horizontal slot 165 may also be stepped, and may comprise a
wider outer portion 170 and a narrower inner portion 175. Wider outer portion
170 may be sized to slidingly receive suture 30 therein so as to help keep
proximal anchor 25 and suture 30 from binding when they are disposed within
inserter 15, but narrower inner portion 175 may be sized to snugly receive
suture
30 therein, whereby to provide a light hold on suture 30 when suture 30 is
disposed therein.
The Suture
As seen in Figs. 3 and 5-8, suture 30 has a distal end 180 terminating in
large ball (or knot) 185 and a proximal end 190. As seen in Fig. 6, suture 30
is
passed through distal anchor 20 so that the suture extends along horizontal
slot 75
of distal anchor 20 and up vertical bore 70 of distal anchor 20. Note that
when
suture 30 is passed through distal anchor 20 in this manner, distal anchor 20
may
be slid along suture 30. As seen in Fig. 8, suture 30 is also passed through
proximal anchor 25 so that the suture extends down vertical bore 140, along
wider
outer portion 170 of bottom horizontal slot 165, up vertical bore 135, forms a
loop
320 above top horizontal slot 145, down vertical bore 130, along wider outer
portion 155 of bottom horizontal slot 150, and up vertical bore 125. Note that
when suture 30 is passed through proximal anchor 25 in this manner, proximal
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anchor 25 may be slid along suture 30, albeit with some effort due to the
serpentine path which suture 30 follows through proximal anchor 25. Note also
that, if bottom horizontal slot 165 comprises a narrower inner portion 175
and/or
if bottom horizontal slot 150 comprises a narrower inner portion 160, a small
amount of additional impedance may be introduced into the system when suture
30 is drawn into narrower inner portion 175 of bottom horizontal slot 165
and/or
suture 30 is drawn into narrower inner portion 160 of bottom horizontal slot
150.
In addition, it should be appreciated that while top horizontal slot 145 of
proximal
anchor 25 is sized to slidingly receive one strand of suture 30 therein, two
or more
1 0 overlapping strands of suture 30 will form a construct of greater
diameter which
may be snugly received within top horizontal slot 145, which may also provide
a
light hold on the two or more overlapping strands of suture when the two or
more
overlapping strands of suture are disposed within top horizontal slot 145.
The Inserter
As seen in Figs. 4 and 26, 27 and 28, inserter 15 generally comprises a
shaft 195, a handle 200 and a pushrod 205.
Shaft 195 generally comprises a hollow tube having a distal end 210, a
proximal end 215 and a lumen 220 extending therebetween. Distal end 210 of
shaft 195 terminates in a sharp point 225. A slot 227 is formed in distal end
210
of shaft 195 and may terminate in a shoulder 228. Alternatively, and more
preferably, slot 227 extends proximally along shaft 195 so that it is
coextensive
with a slot 229 formed in inserter 15 (Fig. 26), whereby to allow suture 30 to
separate from inserter 15 after distal anchor 20 and proximal anchor 25 have
been
set. Lumen 220 is sized to slidably receive distal anchor 20 (Fig. 28) and
proximal anchor 25 (as will hereinafter be discussed). A mount 230 is secured
to
proximal end 215 of shaft 195.
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Handle 200 comprises a distal end 235, a proximal end 240, and a bore
245 extending therebetween. A first counterbore 250 is formed at the distal
end
of handle 200, and a second counterbore 255 is formed just proximal to first
counterbore 250, with first counterbore 250 being sized to receive shaft 195
and
second counterbore 255 being sized to receive mount 230, whereby to secure
shaft 195 to handle 200. A third counterbore 260 is formed at the proximal end
of
handle 200. A groove 265 is formed on the top side of handle 200 for receiving
proximal anchor 25 (Fig. 27). Groove 265 communicates with bore 245 via a
passageway 270, whereby to allow proximal anchor 25 to be advanced into bore
1 0 245, as will hereinafter be discussed. Another groove 275 is formed on
the top
side of handle 200 for slidably receiving a suture sled 280. Suture sled 280
is
biased proximally by a spring 285. Suture sled 280 includes a pair of suture
cleats
290 for releasably securing loop 320 of suture 30 to suture sled 280, as will
hereinafter be discussed.
Pushrod 205 comprises a pusher 295 which is sized to be slidably received
within bore 245 of handle 200 and lumen 220 of shaft 195. Pusher 295 comprises
a distal end 300 (Fig. 28) and a proximal end 305 (Fig. 27). Distal end 300 of
pusher 295 is preferably rounded so as to facilitate turning of distal anchor
20
and/or proximal anchor 25 when they are advanced out of shaft 195 of inserter
15,
2 0 as will hereinafter be discussed. A thumb button 310 is secured to
proximal end
305 of pusher 295, whereby to allow pusher 295 to be advanced distally by
pressing on thumb button 310. Alternatively, thumb button 310 may be used to
retract pusher 295, e.g., by gripping thumb button 310 between the thumb and
forefinger of the user and pulling proximally, whereby to retract pusher 295
proximally. A removable stop 315 (Fig. 27A) may be fitted about thumb button
310, proximal to handle 200, so as to prevent distal movement of thumb button
310 and hence prevent distal movement of pusher 295.
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Prior to use, anchor assembly 10 is mounted to inserter 15. More
particularly, distal anchor 20 is loaded into distal end 210 of shaft 195 so
that
suture 30 extends out slot 227 of shaft 195 (Fig. 28). Proximal anchor 25 is
loaded into groove 265 of handle 200, suture 30 is drawn taut by pulling on
loop
320, and then loop 320 of suture 30 is secured to suture cleats 290. Note that
loop
320 is the portion of suture 30 which extends between where the suture exits
vertical bore 135 of proximal anchor 25 and re-enters vertical bore 130 of
proximal anchor 25. Pushrod 205 is inserted into bore 245 of handle 200 and
lumen 220 of shaft 195 until removable stop 315 engages the proximal end of
handle 200. At this point, distal end 300 of pusher 295 abuts distal anchor 20
(Fig. 28).
Preferably suture assembly 10 is mounted to inserter 15 at the time of
manufacture and prior to packaging and sterilization, although suture assembly
10
may also be mounted to inserter 15 at the time of use if desired.
Exemplary Use Of The Novel System To Close A
Fissure In The Annulus Of An Intervertebral Disc
In use, in order to close a fissure in the annulus of an intervertebral disc,
distal anchor 20 is intended to be positioned on one side of a fissure,
proximal
2 0 anchor 25 is intended to be positioned on another side of the fissure,
and suture 30
is thereafter tensioned so as to close the fissure, whereby to treat
degenerative disc
disease.
By way of example but not limitation, and looking now at Fig. 32, distal
anchor 20 may be passed through the annulus of an intervertebral disc 325 at a
location 330 on one side of a fissure 335, and proximal anchor 25 may be
passed
through the annulus of the same intervertebral disc 325 at a location 340 on
the
opposite side of a fissure 335, so that the suture 30 spans fissure 335 and
holds it
closed.
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By way of further example but not limitation, and looking now at Fig. 33,
distal anchor 20 may be inserted into a vertebral body 345 adjacent to an
intervertebral disc 325 having a fissure 335, and proximal anchor 25 may be
passed through the annulus of that intervertebral disc 325 at a location 340
on the
opposite side of a fissure 335, so that the suture 30 spans fissure 335 and
holds it
closed. Where distal anchor 320 is to be inserted into vertebral body 345, a
hole
may be pre-formed in the vertebral body (e.g., by drilling, tapping, punching,
etc.).
For purposes of illustrating the present invention, an annulus
1 0 reconstruction will now be discussed in the context of positioning
distal anchor 20
in a vertebral body and proximal anchor 25 in the intervertebral disc.
More particularly, and looking now at Figs. 34-38, a hole 350 is formed
(e.g., by drilling, tapping, punching, etc.) in a vertebral body 345 (Fig.
34), the
distal end of shaft 195 is inserted into hole 350 to an appropriate depth
(Fig. 35),
and then removable stop 315 (Fig. 29) is removed from thumb button 310. Then
thumb button 310 is advanced toward handle 200, causing the distal end of
pusher
295 to advance distal anchor 20 out of shaft 195 (Fig. 36). Note that as
distal
anchor 20 is advanced out of shaft 195, suture sled 280 moves distally along
handle 200, against the power of spring 285, thereby allowing suture 30 (and
hence ball 185 set at the distal end of suture 30) to also move distally with
distal
anchor 20. As thumb button 310 continues to advance distally toward handle
200,
suture sled 280 reaches the end of its stroke in groove 275, thereby
preventing
further distal movement of suture 30 (and hence preventing further distal
movement of ball 185 set at the distal end of suture 30). See Fig. 37.
Thereafter,
continued advancement of thumb button 310 toward handle 200 causes distal
anchor 20 to pivot on ball 185 as distal inclined surface 60 of distal anchor
20
rides upward on ball 185, thereby causing distal anchor 20 to rotate within
the
bone (Fig. 38). In essence, as pusher 295 forces distal anchor 20 against the
now-
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stationary ball 185, the camming engagement of inclined distal surface 60 of
distal anchor 20 with ball 185 causes distal anchor 20 to turn within
vertebral
body 345. Thus, the "throw" of suture sled 280 effectively sets the depth of
distal
anchor 20, since it effectively sets the position of ball 185 within the
vertebral
body 345. Inserter 15 is then moved proximally so as to apply a proximal force
to
distal anchor 20 via suture 30, whereby to set distal anchor 20 into vertebral
body
345. Among other things, the pointed heel 87 formed by inclined proximal
surface 65 and proximal notch 85 is set into the vertebral body, whereby to
facilitate setting of distal anchor 20 as suture 30 is pulled proximally. This
completes setting of distal anchor 20.
In this respect it should be appreciated that the provision of the novel
apparatus of the present invention (i.e., distal anchor 20, suture 30 and
inserter 15)
provides a significant advantage over conventional toggle anchors of the prior
art,
since the present invention permits the toggle-type distal anchor 20 to be
reliably
toggled and set in dense tissue such as an intervertebral body and/or an
intervertebral disc. As noted above, conventional toggle-type anchors have had
limited success when set within the interior of tissue in general, and
particularly
when set within the interior of dense tissue such as an intervertebral body
and/or
an intervertebral disc, since they provide inconsistent toggling and low pull-
out
2 0 strengths. By contrast, with the present invention, the unique camming
engagement of inclined distal surface 60 of distal anchor 20 with the
restrained
ball 85 causes distal anchor 20 to turn even when it is within the interior of
dense
tissue such as an intervertebral body and/or an intervertebral disc.
Furthermore,
the pointed heel 87 of distal anchor 20 facilitates setting of the anchor when
suture 30 is tensioned.
Thereafter, loop 320 of suture 30 is released from suture cleats 290,
pushrod 205 is removed from shaft 195 and handle 200, and inserter 15 is
withdrawn from the bone (if it has not already been withdrawn from the bone).
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As this occurs, proximal anchor 25 is drawn distally through passageway 270
and
into bore 245 in handle 200 (due to the fact that proximal anchor 25
encounters
some impedance to sliding along suture 30 since suture 30 follows a serpentine
path through proximal anchor 25, and due to the fact that inserter 15 is being
withdrawn proximally).
Then removable stop 315 is replaced on thumb button 310, and pushrod
205 is advanced into bore 245 of handle 200 and into lumen 220 of shaft 195.
This action advances proximal anchor 25 along lumen 220 of shaft 195. Pushrod
205 is advanced until removable stop 315 engages the proximal end of handle
1 0 200. At this point, proximal anchor 25 is disposed in the distal end of
shaft 195,
but is prevented from being ejected out of the distal end of shaft 195 due to
the
engagement of removable stop 315 with the proximal end of handle 200.
Next, shaft 195 of inserter 15 is inserted through the annulus on the far
side of the fissure, so that suture 30 spans the fissure. See Fig. 38A. Then
removable stop 315 is removed from thumb button 310, and thumb button 310 is
advanced distally so as to cause pusher 295 to eject proximal anchor 25 out of
shaft 195 and into the nucleus of the intervertebral disc. As this occurs, the
geometry of proximal anchor 25 and the tension on suture 30 causes proximal
anchor 25 to begin turning within the nucleus of the intervertebral disc. See
Fig.
38B. Next, shaft 195 of inserter 15 is removed from the annulus, and then loop
320 of suture 30 is pulled proximally, causing suture 30 to be pulled taut,
whereby
to cause proximal anchor 25 to turn further within the nucleus. Where
horizontal
slot 165 includes a narrower inner portion 175, pulling proximally on loop 320
of
suture 30 also causes suture 30 to be drawn into narrower inner portion 175 of
bottom horizontal slot 165. This action can introduce additional impedance
into
the system, and this combined impedance (i.e., the combined impedance provided
by (i) the serpentine path of suture 30 through proximal anchor 25, and (ii)
the
light hold imposed on the suture by narrower inner portion 175 of bottom
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horizontal slot 165) is sufficient to temporarily hold suture 30 to proximal
anchor
25. See Fig. 38C. Thereafter, the proximal end 190 of suture 30 is pulled
lightly
so as to close down loop 320 of suture 30 somewhat. See Fig. 38D. Then
proximal end 190 of suture 30 is passed through loop 320 of suture 30, whereby
to form a so-called "half-hitch" configuration. See Fig. 38E. Next, proximal
end
190 of suture 30 is pulled so as to draw loop 320 of suture 30 down into the
nucleus of the intervertebral disc. See Fig. 38F. Pulling continues until the
half-
hitch configuration of loop 320 and proximal end 190 of suture 30 are drawn
into
top horizontal slot 145 of proximal anchor 25, i.e., so that the
aforementioned
half-hitch is disposed in top horizontal slot 145 of proximal anchor 25,
whereby to
prevent the half-hitch from slipping through itself and hence securing suture
30 to
proximal anchor 25. As this occurs, suture 30 is also pulled into bottom
horizontal slot 150 and, where bottom horizontal slot 150 includes narrower
inner
portion 160, into the narrower inner portion 160 of bottom horizontal slot
150,
whereby to further hold suture 30 to proximal anchor 25. See Fig. 38G.
The proximal end 190 of suture 30 may then be trimmed away, whereby to
complete the repair.
In this respect it should be appreciated that the unique construction of
proximal anchor 25 provides a significant advantage over the conventional
toggle
2 0 anchors of the prior art, since it provides novel means for knotles sly
securing
suture 30 to proximal anchor 25, whereby to allow the tension of suture 30 to
be
reliably set between distal anchor 20 and proximal anchor 25. Significantly,
the
novel construction provided by proximal anchor 25 provides a unique solution
to
the problem of knotles sly securing suture to an anchor. More particularly,
the
knotless securement mechanism of proximal anchor 25 avoids the deficiencies of
prior art toggle anchor systems using cinch knots (see Cauthen III et al. as
discussed above) and/or filament enlargements/anchor narrowings (see Cauthen
III et al. as discussed above).
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In addition, the knotless securement mechanism of proximal anchor 25
provides a significant improvement over the prior art serpentine suture
securement mechanisms sometimes found in prior art bone anchors. More
particularly, various prior art bone anchors (e.g., screw-type bone anchors)
have
previously attempted to use serpentine passageways through the bone anchor to
knotlessly secure a suture to the bone anchor. However, such prior art
serpentine
suture securement mechanisms have traditionally required the designer to
choose
between low holding strength (but relative ease in pulling the suture through
the
serpentine passageways) or high holding strength (and significant difficulty
in
1 0 pulling the suture through the serpentine passageways). The present
invention
avoids this problem, providing both high holding strength and relative ease of
pulling the suture through the serpentine passageways, by (i) allowing the
suture
to be accessed at a midpoint within the anchor's serpentine pathway (e.g., by
pulling on loop 320), and (ii) providing additional holding means to
supplement
the holding power of the serpentine suture pathway (i.e., the aforementioned
half-
hitch and, to a significantly lesser extent, the friction fit of suture 30
within
narrower inner portion 175 of bottom horizontal slot 165 and narrower inner
portion 160 of bottom horizontal slot 150 (to the extent that bottom
horizontal slot
165 comprises a narrower inner portion 175 and bottom horizontal slot 150
comprises a narrower inner portion 160).
Thus, with the present invention, the distal anchor 20 is set into tissue on
one side of the fissure, the proximal anchor is deployed into tissue on the
other
side of the fissure, and then the suture is appropriately tensioned and made
fast to
the proximal anchor, whereby to effect the repair with the degree of tension
selected by the user. Furthermore, with the present invention, the distal
anchor
can be reliably turned and set within the interior of relatively dense tissue
such as
bone (as well as within the interior of other tissue) due to its unique
construction
and deployment mechanism. And with the present invention, the proximal anchor
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is capable of providing high holding strengths, e.g., on the order of 16
pounds of
holding strength. In this respect it should be appreciated that proximal
anchor 25
is held to suture 30 to a large extent by the impedance provided by the half-
hitch
construct (which is aided against slipping by virtue of its disposition in top
horizontal slot 145), and to a lesser extent by the serpentine suture path
through
proximal anchor 25, and to a much smaller extent by the light hold imposed on
suture 30 by narrower inner portion 175 of bottom horizontal slot 165 and
narrower inner portion 155 of bottom horizontal slot 150 (to the extent that
bottom horizontal slot 165 comprises a narrower inner portion 175 and bottom
horizontal slot 150 comprises a narrower inner portion 160).
Note that where bottom horizontal slot 165 comprises a narrower inner
portion 175, the hold imposed on suture 30 by narrower inner portion 175 of
bottom horizontal slot 165 may be relatively nominal, inasmuch as it provides
a
useful impedance on suture 30 only during the brief period of time that loop
320
is being reduced and the aforementioned half-hitch is being formed ¨ after
loop
320 has been reduced and the aforementioned half-hitch has been set, the
significant holding power on suture 30 is provided by the half-hitch construct
and
the serpentine suture path extending through proximal anchor 25. In this
respect
it should also be appreciated that, where bottom horizontal slot 165 comprises
a
narrower inner portion 175, and during the brief period of time that narrower
inner portion 175 is providing a useful impedance on suture 30, the patient is
lying stationary on the operating table and only a nominal load is imposed on
the
suture - unlike when the patient is upright and moving about, when a
substantial
load is imposed on the suture.
By way of example but not limitation, in one form of the present
invention, where bottom horizontal slot 165 comprises a narrower inner portion
175 and bottom horizontal slot 150 comprises a narrower inner portion 160, the
serpentine suture path through proximal anchor 25, plus the light impedance
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imposed on suture 30 by narrower inner portion 175 of bottom horizontal slot
165
and narrower inner portion 155 of bottom horizontal slot 150, collectively
provide
about 4-6 pounds of holding strength, and the half-hitch construct of proximal
end
190 of suture 30 passing through loop 320, with the half-hitch construct being
drawn into top horizontal slot 145 of proximal anchor 25, brings the total
holding
strength to about 16 pounds of holding strength.
Tensioner(s) Which May Be Used In
Conjunction With The Novel System
1 0 It will be appreciated that, due to the tortuous path of suture 30
through
proximal anchor 25, as well as the need to pull the half-hitch construct into
top
horizontal slot 145 and, where bottom horizontal slot 165 comprises a narrower
inner portion 175 and bottom horizontal slot 150 comprises a narrower inner
portion 160, to pull suture 30 into the narrower inner portion 175 of bottom
horizontal slot 165 and narrower inner portion 160 of bottom horizontal slot
150,
substantial force must be applied to the proximal end of suture 30 in order to
pull
the length of suture between the anchors 20, 25 taut and secure the suture in
position. This level of force is significantly greater than the level of force
required to set distal anchor 20. Where the annulus of the vertebral disc is
weak,
2 0 the application of such a force to the proximal end of suture 30
presents the
possibility of pulling proximal anchor 25 through the annulus. Therefore, in
order
to eliminate the possibility of this occurrence, it may be desirable to
utilize a
tensioner 375 (Figs. 39-41) to hold the annulus in place while applying
proximal
tension to suture 30.
More particularly, a suture retriever 380, having a loop 385 at its distal
end, is advanced through a lumen 390 of tensioner 375 (Fig. 39). The proximal
end of suture 30 is fed through loop 385, which is then pulled proximally
through
the tensioner so as to draw suture 30 through the tensioner (Fig. 40). The
feet 395
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of tensioner 375 are then placed against the annulus adjacent to where suture
30
exits the annulus, and suture 30 is then pulled proximally, whereby to tension
the
suture and set it in position. As this occurs, feet 395 of tensioner 375
prevent the
annulus from bowing outward, which could enable proximal anchor 25 to pass
through the annulus.
Alternatively, and looking now at Figs. 41A and 41B, a tensioner 400 may
be provided. Tensioner 400 generally comprises a shaft 405 having a distal end
410 and a proximal end 415. Distal end 410 terminates in a foot 420. A ramped
suture pathway 425 extends through distal end 410 of shaft 405 and through
foot
420. Proximal end 415 of shaft 405 is mounted to a handle 430. A cutter tube
435 is slidably mounted on shaft 405. Cutter tube 435 has a sharpened distal
rim
440.
In use, when suture 30 is to be tensioned, the proximal end 190 of suture
30 is fed through ramped suture pathway 425, foot 420 is placed against the
annulus adjacent to where suture 30 exits the annulus, and then suture 30 is
tensioned, with foot 420 of the tensioner preventing the annulus from bowing
outward. Thereafter, excess suture may be cut away by moving cutter tube 435
distally along shaft 405 until its sharpened distal rim 440 engages and trims
away
excess suture.
Further Applications Of The Novel System
In the foregoing description, system 5 is discussed in the context of
closing a fissure in the annulus of an intervertebral disc. However, it should
be
appreciated that system 5 may also be used to effect other anatomical repairs
and/or fixations.
By way of example but not limitation, the present invention may be used
to hold two pieces of soft tissue in apposition to one another to effect a
repair
(e.g., so as to close an incision in the skin). See, for example, Fig. 42,
where
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distal anchor 20 is shown disposed within the interior of one piece of soft
tissue
and proximal anchor 25 is shown disposed within the interior of another piece
of
soft tissue; and Fig. 43, where distal anchor 20 is shown disposed against an
outer
surface of one piece of soft tissue and proximal anchor 25 is shown disposed
against an outer surface of another piece of soft tissue. Or the present
invention
may be used to hold two pieces of cartilage in apposition to one another to
effect a
repair (e.g., so as to close a tear in meniscal cartilage). See, for example,
Fig. 44,
where distal anchor 20 is shown disposed within the interior of one section of
meniscal cartilage and proximal anchor 25 is shown disposed within the
interior
1 0 of another section of the same meniscal cartilage; and Figs. 45 and 46,
where
distal anchor 20 is shown disposed against an outer surface of one section of
meniscal cartilage and proximal anchor 25 is shown disposed against an outer
surface of another section of the same meniscal cartilage. Or the present
invention may be used to hold two pieces of bone in apposition to one another
so
as to effect a repair (e.g., so as to fuse together bone). See Fig. 47.
By way of further example but not limitation, the present invention may
be used to hold a piece of soft tissue in apposition to bone to effect a
repair (e.g.,
so as to attach soft tissue to bone). See, for example, Fig. 48. Or the
present
invention may be used to hold a piece of cartilage in apposition to bone to
effect a
2 0 repair (e.g., so as to attach labrum to bone or to attach meniscal
cartilage to bone).
See Fig. 49.
By way of further example but not limitation, the present invention may
be used to hold a prosthesis in apposition to soft tissue or bone, or to hold
soft
tissue or bone in apposition to a prosthesis, and/or to hold any first object
in
apposition to any second object.
It is also possible to use just distal anchor 20 and suture 30 to effect
anatomical repairs and/or fixations, with proximal anchor 25 being omitted
altogether. See, for example, Fig. 50, where a knot is used to hold soft
tissue to a
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bone receiving distal anchor 20, and Fig. 51, where a knot is used to hold a
labrum to an acetabular rim receiving distal anchor 20. If desired, multiple
suture
strands may be attached to the large ball (or knot) 185 which is positioned
distal
to distal anchor 20, which can facilitate repair and/or fixation procedures.
It is also possible to use proximal anchor 25 and suture 30 with an anchor
other than distal anchor 20 to effect anatomical repairs and/or fixations. By
way
of example but not limitation, proximal anchor 25 and suture 30 may be used in
conjunction with a conventional bone anchor (e.g., a conventional screw-type
bone anchor or by a conventional barb-type bone anchor), with the conventional
bone anchor replacing the aforementioned distal anchor 20 of the present
invention.
The following is a list of just some of the indications in which the present
invention may be used:
- Foot/Ankle
- Hallux Valgus Repair
- Hallux Varus Repair
- Lisframe Repair
- Correction Of The Intermediate Tarsal Angle
- Brostrum Repair
2 0 - Achilles Tendon Repair/Reconstruction
- Medial Capsuloraphy Hallus Valgus
- Lateral Stabilization
- Medial Stabilization
- Great Toe Tendon Repair
- Mid- And Forefoot Tendon Reconstruction
- Hand/Wrist
- CMC ¨ Thumb Instability
- CMC ¨ Ligament Reconstruction
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- Ulnar ¨ Collateral Ligament Repair
- Scaphonlunate Repair
- TFCC
- Flexor Tendon Repair
- Plastics/Maxillofacial
- Brow Lift
- Face/Forehead Lift
- Breast Lift
- Breast Reconstruction
1 0 - Crows Feet Repair
- Blepharoplasty
-Hip
- Hip Labrum Repair
- Shoulder
- Rotator Cuff Repair
- Partial Rotator Cuff Repair
- Instability Repair (SLAP, Bankhart)
- Capsular Shift
- Capsular Plication
- Tendon Transfers For Arthroplasty
- Reverse Shoulder Arthroplasty Soft Tissue
Management
- Acromio-Clavicular Separation
- Deltoid Repair
- Biceps Tenodesis
- Knee
- Meniscus Repair
- Medial Collateral Ligament Repair
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- Lateral Collateral Ligament Repair
- Elbow
- Distal Biceps Repair
- Medial And Lateral Repairs
- Tennis Elbow Repair
Use In Anchoring Sensory Nerve Stimulator (SNS) Leads
As noted above, novel system 5 may be used to close a fissure in the
annulus of an intervertebral disc, and/or to effect other anatomical repairs
and/or
1 0 other anatomical fixations.
In one preferred form of the invention, novel system 5 may be used in a
novel approach to anchor sensory nerve stimulator (SNS) leads. More
particularly, in sensory nerve stimulation therapy, electrical leads are
positioned
adjacent to nerves and used to deliver electrical stimulation to those nerves
so as
to provide pain relief to a patient. In one significant application of nerve
stimulation therapy, sensory nerve stimulator (SNS) leads are disposed
adjacent to
nerves in the spinal column, whereby to deliver electrical stimulation to
those
nerves and provide pain relief to the patient. See, for example, Fig. 52,
which
shows an SNS lead disposed adjacent to a nerve in the spinal column.
2 0 In practice, it has been found extremely difficult to reliably
anchor an SNS
lead adjacent to a nerve in the spinal column. This is due to, among other
things,
the highly complex and varying anatomy of the spinal column, the need to
fabricate the SNS lead with an atraumatic configuration, and the need to
ensure
that the SNS lead is reliably fixed in position. These factors, and others,
combine
to make it extremely difficult to reliably anchor an SNS lead adjacent to a
specific
nerve in the spinal column.
Novel system 5 provides a new and improved approach for stabilizing an
SNS lead adjacent to a nerve in the spinal column, by anchoring the SNS lead
to
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one mass of material using the distal anchor of system 5 and by anchoring the
SNS lead to another mass of material using the proximal anchor of system 5,
with
the intervening suture securing the SNS lead reliably in position. Among other
things, novel system 5 comprises a distal anchor 20 which is deployable, using
a
minimally-invasive approach, against the exterior of a hard or soft object
(e.g., a
bone, soft tissue, a hard prosthesis, a soft prosthesis, etc.), or within the
interior of
a hard or soft object (e.g., a bone, soft tissue, a hard prosthesis, a soft
prosthesis,
etc.), thereby providing a wide range of objects to which the distal anchor
may be
secured. Novel system 5 also comprises a proximal anchor 25 which is
1 0 deployable, using a minimally-invasive approach, against the exterior
of a hard or
soft object (e.g., a bone, soft tissue, a hard prosthesis, a soft prosthesis,
etc.), or
within the interior of a soft object (e.g., soft tissue, a soft prosthesis,
etc.), thereby
providing a wide range of objects to which the distal anchor may be secured.
And
novel system 5 comprises a connecting suture 30 which may be used to
atraumatically, but reliably, secure an SNS lead in position.
Note that for the purposes of the present invention, the term "bone" is
intended to include any bone or bone-like structure including, but not limited
to, a
vertebral body, a pedicle, a transverse process, a facet structure, a lamina,
a
spinous process, etc. Note also that for the purposes of the present
invention, the
2 0 term "soft tissue" is intended to include any relatively "soft"
structure including,
but not limited to, an intervertebral disc, a muscle, a ligament, a tendon,
etc.
See, for example, Fig. 53, which shows an SNS lead L adjacent to one
mass of material M1 for receiving distal anchor 20 of system 5, and adjacent
to
another mass of material M2 for anchoring proximal anchor 25 of system 5. Fig.
54 shows distal anchor 20 deployed against the exterior of a hard or soft mass
of
material M1 (e.g., a bone, soft tissue, a hard prosthesis, a soft prosthesis,
etc). Fig.
55 shows distal anchor 20 deployed within the interior of a hard or soft mass
of
material M1 (e.g., a bone, soft tissue, a hard prosthesis, a soft prosthesis,
etc.).
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Fig. 56 shows proximal anchor 25 deployed against the exterior of a hard or
soft
mass of material M2 (e.g., a bone, soft tissue, a hard prosthesis, a soft
prosthesis,
etc). Fig. 57 shows proximal anchor 25 deployed within the interior of a soft
mass of material M2 (e.g., soft tissue, a soft prosthesis, etc.).
Thus, with the present invention, distal anchor 20 may be deployed
through, or deployed within, any appropriate anatomical or prosthetic
structure,
and proximal anchor 25 may be deployed through, or deployed within, any
appropriate anatomical or prosthetic structure, whereby to enable suture 30 to
secure SNS lead L in the desired position within the patient's anatomy.
As seen in Fig. 58, suture 30 may simply extend over SNS lead L, holding
the SNS lead against underlying tissue. Alternatively, as shown in Fig. 59,
suture
30 may be wrapped around SNS lead L. Where suture 30 is wrapped around the
SNS lead, it may be possible to support the SNS lead in position even in the
absence of underlying tissue, since suture 30 can be used to suspend SNS lead
L
over a gap in the tissue. Furthermore, if desired, SNS lead L may include an
associated mount, e.g., in the form of a web W extending laterally about the
SNS
lead, and distal anchor 20 and proximal anchor 25 may be advanced through web
W prior to deployment through or into a mass of material (e.g., M1 or M2), in
the
manner shown in Figs. 61 and 62.
Figs. 63-70 show a variety of ways in which system 5 may be used to
secure SNS lead L to adjacent structures.
Proximal Anchor Comprising Flexible Finger
As noted above, novel system 5 may be used to close a fissure in the
annulus of an intervertebral disc, and/or to effect other anatomical repairs
and/or
other anatomical fixations, including anchoring sensory nerve stimulator (SNS)
leads.
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In another preferred form of the present invention, novel system 5 utilizes
the aforementioned distal anchor 20 and the aforementioned suture 30 (and also
the aforementioned inserter 15), but substitutes an alternative proximal
anchor
25A (Figs. 71 and 72) for the aforementioned proximal anchor 25.
More particularly, in this form of the invention, proximal anchor 25A
comprises a generally cylindrical body 90A having a distal end 95A, a proximal
end 100A and a generally circular side wall 105A. Distal end 95A terminates in
a
distal surface 110A. Proximal end 100A terminates in a proximal surface 120A.
A vertical bore 126A passes completely through proximal anchor 25A. Vertical
bore 126A is sized to slidably receive suture 30 therein. A recess 131A passes
part way through proximal anchor 25A. A U-shaped slot 136A passes part way
through proximal anchor 25A. Recess 131A and U-shaped slot 136A together
define a flexible finger 141A. In this form of the invention, a gap 142A is
formed
between the inner tip 143A of flexible finger 141A and the edge 144A formed at
the convergence of recess 131A and U-shaped slot 136A. Preferably gap 142A is
sized so as to be approximately 50% of the width of suture 30 when flexible
finger 141A is in its relaxed, unbiased condition (i.e., in the position shown
in
Figs. 71 and 72) and when suture 30 is in its normal, uncompressed condition.
A
bottom horizontal slot 151A extends between vertical bore 126A and recess
131A. Bottom horizontal slot 151A may be stepped, comprising a wider outer
portion 156A and a narrower inner portion 161A. If desired, wider outer
portion
156A may be sized to slidably receive suture 30 therein so as to help keep
proximal anchor 25A and suture 30 from binding when they are disposed within
the aforementioned inserter 15, but narrower portion 161A may be sized to
snugly
receive suture 30 therein whereby to provide a light hold on suture 30 when
suture
is disposed therein.
As seen in Figs. 71 and 72, suture 30 is passed through proximal anchor
25A so that suture 30 extends down vertical bore 126A, through wider outer
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portion 156A of bottom horizontal slot 151A, up through recess 131A and out U-
shaped slot 136A. Note that inasmuch as suture 30 has a diameter which is
approximately twice the size of gap 142A formed between inner tip 143A of
flexible finger 141A and edge 144A of proximal anchor 25A, flexible finger
141A will normally bear against the suture disposed in gap 142A. In this
condition, the presence of the "oversized" suture 30 in the "undersized" gap
142A
will cause flexible finger 141A to be flexed upwardly (from the angle of view
of
Figs. 71 and 72) so as to accommodate suture 30, with inner tip 143A of
flexible
finger 141A capturing the suture against edge 144A of proximal anchor 25A.
1 0 Note that some compression of suture 30 may occur in this condition.
In addition to the foregoing, it should be appreciated that suture 30 follows
a non-linear path through proximal anchor 25A, and this non-linear path
creates
impedance to the passage of suture 30 through proximal anchor 25A.
In use, after the aforementioned distal anchor 20 has been deployed at the
surgical site (preferably using the aforementioned inserter 15), proximal
anchor
25A is also deployed at the surgical site (again, preferably using the
aforementioned inserter 15), and then suture 30 is set by pulling proximally
on
suture 30. As suture 30 is pulled proximally, flexible finger 141A flexes away
from the body of proximal anchor 25A, thereby allowing suture 30 to slide
2 0 through recess 131A and U-shaped slot 136A (as well as through vertical
bore
126A and wider outer portion 156A of bottom horizontal slot 151A). When the
slack in suture 30 has been taken up, and suture 30 is thereafter tensioned
further,
where bottom horizontal slot 151A comprises a narrower portion 161A, suture 30
is pulled from wider outer portion 156A of bottom horizontal slot 151A into
narrower portion 161A of bottom horizontal slot 151A so that suture 30 is
snugly
received therein, such that proximal anchor 25A provides a light hold on
suture
30. When tension on the free end of suture 30 is thereafter relaxed, flexible
finger
141A flexes back toward the body of proximal anchor 25A, whereby to lock
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suture 30 to proximal anchor 25A (i.e., with inner tip 143A of flexible finger
141A capturing the suture against edge 144A of proximal anchor 25A). In
addition, inasmuch as suture 30 follows a non-linear path through proximal
anchor 25A, the non-linear path creates impedance to the passage of suture 30
through proximal anchor 25A. In this way, suture 30 is secured to proximal
anchor 25A. Thereafter, a half-hitch may be formed in suture 30 on the
proximal
side of proximal anchor 25A so as to further secure suture 30 to proximal
anchor
25A.
Single Anchor Fixation
In another preferred form of the present invention, and looking now at Fig.
73, a single anchor system 500 may be used to secure an object (e.g., a
sensory
nerve stimulator "SNS" lead 505) to tissue (e.g., fascia 510). In this form of
the
invention, single anchor system 500 comprises a novel anchor 515 and a suture
520. Single anchor system 500 is preferably deployed using the aforementioned
inserter 15 (or another appropriate inserter).
More particularly, anchor 515 comprises a generally cylindrical body 535
having a distal end 540, a proximal end 545 and a generally circular side wall
550. Distal end 540 terminates in a flat or somewhat inclined distal end
surface
2 0 555 and a more inclined distal end surface 560. Flat or somewhat
inclined distal
end surface 555 is sufficiently large so as to render distal end 540 of anchor
515
substantially blunt (but, where distal end surface 555 is somewhat inclined,
also
having a tapered lead-in). Inclined distal end surface 560 is pitched at an
appropriate angle (e.g., 30 degrees, 45 degrees, etc.) so as to cause anchor
515 to
turn during deployment (in the same manner that the aforementioned distal
anchor
20 comprises a corresponding inclined distal surface 60 for causing turning),
as
will hereinafter be discussed. Proximal end 545 terminates in an inclined
proximal end surface 565.
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A vertical bore 570 passes through anchor 515. Vertical bore 570 is sized
to slidably receive suture 520 therein. A horizontal slot 575 extends between
inclined distal end surface 560 and vertical bore 570. Horizontal slot 575 is
preferably also sized to slidably receive suture 520 therein, and helps keep
anchor
515 and suture 520 from binding when they are disposed within the
aforementioned inserter 15. A pair of vertical bores 581, 583 are also
disposed in
anchor 515, proximal to vertical bore 570. Vertical bores 581, 583 are also
sized
to slidably receive suture 520 therein. A bottom horizontal slot 586 extends
between vertical bore 581 and vertical bore 583.
Significantly, suture 520 follows a non-linear path through anchor 515,
and this non-linear path creates impedance to the passage of suture 520
through
anchor 515.
If desired, bottom horizontal slot 586 may be stepped, comprising a wider
outer portion 587 and a narrower inner portion 588. Wider outer portion 587
may
be sized to slidably receive suture 520 therein so as to help keep anchor 515
and
suture 520 from binding when they are disposed within the aforementioned
inserter 15, but narrower portion 588 may be sized to snugly receive suture
520
therein, whereby to provide a light hold on suture 520 when suture 520 is
disposed therein.
As seen in Fig. 73, suture 520 has a distal end 591 terminating in a large
ball (or knot) 592, and a proximal segment 593. Suture 520 is passed through
anchor 515 so that so that large ball (or knot) 592 is disposed against the
more
inclined distal end surface 560, and the suture extends along horizontal slot
575 of
anchor 515, up vertical bore 570 of anchor 515, around the object (e.g., a
sensory
nerve stimulator "SNS" lead 505) which is to be secured to tissue (e.g.,
fascia
510), down vertical bore 581, through bottom horizontal slot 586 (i.e.,
through
wider outer portion 587 of bottom horizontal slot 586 where bottom horizontal
slot is stepped), and up vertical bore 583.
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In use, anchor 515 is deployed at the surgical site with suture 520 under
tension so that anchor 515 is turned as it is ejected from the aforementioned
inserter 15 (in the same manner that the aforementioned distal anchor 20 is
turned
as it is ejected from the aforementioned inserter 15), then suture 520 is
tensioned
by pulling proximally on proximal end 593 of suture 520. As suture 520 is
tensioned, sensory nerve stimulator "SNS" lead 505 is secured against fascia
510
(i.e., by virtue of anchor 515 being set in fascia 510 and by virtue of lead
505
being captured to anchor 515 via suture 520). Note that suture 520 will be
held
against slippage relative to anchor 515 by virtue of the fact that suture 520
follows
a non-linear path through anchor 515, and this non-linear path creates
impedance
to the passage of suture 520 through anchor 515. When suture 520 is thereafter
tensioned further, and where bottom horizontal slot 586 comprises a narrower
portion 588, suture 520 will be pulled from wider outer portion 587 of bottom
horizontal slot 586 into narrower portion 588 of bottom horizontal slot 586 so
that
suture 520 is snugly received therein. This can provide an additional hold on
suture 520. Thereafter, a half-hitch 594 is formed in suture 520 on the
proximal
side of anchor 520 so as to secure the fixation. In this form of the
invention, half
hitch 594 will provide the primary fixation of suture 520 to anchor 515, and
the
impedance created by the non-linear path of suture 520 through anchor 515 will
2 0 provide significant additional fixation of suture 520. Where bottom
horizontal
slot 586 comprises a narrower portion 588, movement of suture 520 into
narrower
portion 588 can also provide a small additional holding force.
Single Anchor Fixation Utilizing
Anchor Comprising Flexible Finger
In another preferred form of the present invention, and looking now at
Figs. 74-85, a single anchor system 600 may be used (e.g., with the
aforementioned inserter 15) to secure an object (e.g., a sensory nerve
stimulator
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SNS lead 605) to tissue (e.g., fascia 610). In this form of the invention,
single
anchor system 600 comprises a novel anchor 615 and a suture 620. Single anchor
system 600 is preferably deployed using the aforementioned inserter 15 (or
another appropriate inserter).
More particularly, anchor 615 comprises a generally cylindrical body 625
having a distal end 630, a proximal end 635 and a generally circular side wall
640. Distal end 630 terminates in a flat or somewhat inclined distal end
surface
645 and a more inclined distal end surface 650. Flat or somewhat inclined
distal
end surface 645 is sufficiently large so as to render distal end 630 of anchor
615
1 0 substantially blunt (but, where distal end surface 645 is somewhat
inclined, also
having a tapered lead-in). Inclined distal end surface 650 is pitched at an
appropriate angle (e.g., 30 degrees, 45 degrees, etc.) so as to cause anchor
615 to
turn during deployment (in the same manner that the aforementioned distal
anchor
20 comprises a corresponding inclined distal surface 60 for causing turning),
as
will hereinafter be discussed. Proximal end 635 terminates in an inclined
proximal end surface 655.
A vertical bore 660 passes completely through anchor 615. Vertical bore
660 preferably intersects inclined distal end surface 650 and is sized to
slidably
receive suture 620 therein. A recess 665 passes part way through anchor 615. A
U-shaped slot 670 passes part way through anchor 615. Recess 665 and U-shaped
slot 670 together define a flexible finger 675. In this form of the invention,
a gap
680 is formed between the inner tip 685 of flexible finger 675 and the edge
690
formed at the convergence of recess 665 and U-shaped slot 670. Preferably gap
680 is sized so as to be approximately 50% of the width of suture 620 when
flexible finger 675 is in its relaxed, unbiased condition (i.e., in the
position shown
in Figs. 78 and 83) and when suture 620 is in its normal, uncompressed
condition.
A bottom horizontal slot 695 extends between vertical bore 660 and recess 665.
Bottom horizontal slot 695 may be stepped, comprising a wider outer portion
700
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and a narrower inner portion 705. If desired, wider outer portion 700 may be
sized to slidably receive suture 620 therein so as to help keep anchor 615 and
suture 620 from binding when they are disposed within the aforementioned
inserter 15, but narrower portion 705 may be sized to snugly receive suture
620
therein whereby to provide a light hold on suture 620 when suture 620 is
disposed
therein. Alternatively, bottom horizontal slot 695 may comprise a slot of
uniform
width with a chamfer lead-in.
As seen in Fig. 83, suture 620 has a distal end 710 terminating in a large
ball or knot 715, a proximal segment 720, and an intermediate loop 725 which
1 0 may be releasably secured to suture sled 280 of inserter 15. Suture 620
is passed
through anchor 615 so that large ball or knot 715 is disposed against the more
inclined distal end surface 650, and the suture extends into vertical bore
660,
loops around to form loop 725 (which is preferably releasably secured to
suture
sled 280 of inserter 15) and extends back down vertical bore 660, through
wider
outer portion 700 of bottom horizontal slot 695 (if bottom horizontal slot 695
is
stepped), up through recess 665 and out U-shaped slot 670. Note that inasmuch
as suture 620 has a diameter which is approximately twice the size of gap 680
formed between inner tip 685 of flexible finger 675 and edge 690 of anchor
615,
flexible finger 675 will normally bear against the suture disposed in gap 680.
In
2 0 this condition, the presence of the "oversized" suture 620 in the
"undersized" gap
680 will cause flexible finger 675 to be flexed upwardly (from the angle of
view
of Fig. 83) so as to accommodate suture 620, with inner tip 685 of flexible
finger
675 capturing the suture against edge 690 of anchor 615. Note that some
compression of suture 620 may occur in this condition.
In addition to the foregoing, it should be appreciated that suture 620
follows a non-linear path through anchor 615, and this non-linear path creates
impedance to the passage of suture 620 through anchor 615.
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In use, anchor 615 is deployed at the surgical site with suture 620 under
tension so that anchor 615 is turned as it is ejected from the aforementioned
inserter 15 (in the same manner that the aforementioned distal anchor 20 is
turned
as it is ejected from the aforementioned inserter 15). In one preferred form
of the
invention, this is accomplished by releasably mounting loop 725 of suture 620
to
suture sled 280 of inserter 15 during insertion of anchor 615. Then loop 725
of
suture 620 is released from suture sled 280, SNS lead 605 is passed through
loop
725, and then suture 620 is tensioned by pulling proximally on proximal end
720
of suture 620. As suture 620 is tensioned, flexible finger 675 flexes away
from
the body of anchor 615, thereby allowing suture 620 to slide through recess
680
and U-shaped slot 670 (as well as through vertical bore 660 and wider outer
portion 700 of bottom horizontal slot 695). When the slack in suture 620 has
been
taken up, whereby to pull SNS lead 605 tight against fascia 610, and suture
620 is
thereafter tensioned further, where bottom horizontal slot 695 comprises a
narrower portion 705, suture 620 is pulled from wider outer portion 700 of
bottom
horizontal slot 695 into narrower portion 705 of bottom horizontal slot 695 so
that
suture 620 is snugly received therein, such that anchor 615 provides a light
hold
on suture 620. When tension on the free end of suture 620 is thereafter
relaxed,
flexible finger 675 flexes back toward the body of anchor 615, whereby to lock
suture 620 to anchor 615 (i.e., with inner tip 685 of flexible finger 675
capturing
the suture against edge 690 of anchor 615). In addition, inasmuch as suture
620
follows a non-linear path through anchor 615, the non-linear path creates
impedance to the passage of suture 620 through anchor 615. In this way, suture
620 is secured to anchor 615. Thereafter, if desired, a half-hitch may be
formed
in suture 620 on the proximal side of anchor 615 so as to further secure
suture 620
to anchor 615, and hence secure SNS lead 605 to fascia 610.
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In one preferred form of the invention, single anchor system 600 is
configured so that its failure mode comprises slipping, not breaking (i.e.,
suture
620 will slip relative to anchor 615 before anchor 615 will break).
And in one preferred form of the invention, anchor 615 comprises carbon
fiber-reinforced PEEK (30%).
Furthermore, if desired, anchor 615 may comprise a radiopaque material
so that anchor 615 is visible under X-ray visualization. By way of example but
not limitation, a radiopaque element may be incorporated in the body of anchor
615. By way of further example but not limitation, a piece of Nitinol wire may
be
molded into anchor 615 so that the Nitinol wire extends through flexible
finger
675 and into the adjoining body of anchor 615 ¨ in this form of the invention,
the
Nitinol wire reinforces flexible finger 675 at the same time that it provides
a
radiopaque element in anchor 615.
Inserter With Alternative Suture Sled
In the foregoing disclosure, inserter 15 is characterized as having a suture
sled 280 which is spring mounted to handle 200. Suture sled 280 serves as a
movable mount for securing the proximal portion of suture loop 320 (or suture
loop 725) to handle 200, such that suture sled 280 can slide along handle 200
as
distal anchor 20 (or anchor 615) is advanced into a mass of material (e.g., an
intervertebral disc, a bone, soft tissue, etc.), and then be stopped relative
to handle
200 so that distal anchor 20 (or anchor 615) is driven against ball 185 (or
ball
715), whereby to facilitate turning of distal anchor 20 (or anchor 615) within
the
mass of material.
To this end, in the foregoing disclosure, suture sled 280 is characterized as
being spring mounted to handle 200 so that suture sled 280 initially remains
in a
proximal position, whereby to hold suture 30 (or suture 620) under tension,
until
distal anchor 20 (or anchor 615) is driven distally by push rod 205 of
inserter 15,
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whereupon suture sled 280 is permitted to move distally, against the power of
spring 285, until distal anchor 20 (or anchor 615) is at the proper depth
within the
mass of material, whereupon distal movement of suture sled 280 is stopped,
thereby stopping distal movement of ball 185 (or ball 715) and hence setting
the
depth of distal anchor 20 (or anchor 615).
However, if desired, spring 285 may be omitted, and other means may be
provided for releasably holding suture sled 280 in a proximal position until
distal
anchor 20 (or anchor 615) is driven distally by push rod 205. By way of
example
but not limitation, suture sled 280 may be releasably held in a proximal
position
1 0 by means of a yielding stop finger, a ball-and-detent mechanism, or
other
releasable holding mechanism of the sort well known in the art.
Inserter With Impulse Driver
In the foregoing disclosure, inserter 15 is characterized as having a push
rod 205 which is moved distally by manually pressing on thumb button 310
(e.g.,
in the manner of manually pressing on the plunger of a syringe), whereby to
drive
distal anchor 20 (or anchor 615) distally.
However, in some circumstances it can be desirable to drive distal anchor
(or anchor 615) with an impulse mechanism, so that an impulse of drive
20 energy is applied to distal anchor 20 (or anchor 615). By way of example
but not
limitation, where distal anchor 20 (or anchor 615) is formed out of a material
having limited strength (e.g., PEEK or PLLA), and where distal anchor 20 (or
anchor 615) is to be set in a harder mass of material (e.g., bone), it can be
helpful
to set distal anchor 20 (or anchor 615) with an impulse mechanism.
To this end, and looking now at Fig. 86, inserter 15 may be provided with
a tension spring 800 which is secured to proximal end 240 of handle 200 and to
thumb button 310 of push rod 205. With such a construction, thumb button 310
may be pulled proximally, away from handle 200, so that tension spring 800 is
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stretched and then, when impulse energy is to be applied to distal anchor 20
(or
anchor 615) via push rod 205, thumb button 310 is simply released, so that
tension spring 800 applies impulse energy to thumb button 310 and hence causes
push rod 205 to apply impulse energy to distal anchor 20 (or anchor 615).
Single Anchor Fixation Utilizing Anchor Comprising
Flexible Finger And Suture Loading Hole
As discussed above, the free end of suture 620 is passed through suture
anchor 615 (i.e., up through vertical bore 660, back down through vertical
bore
660, across bottom horizontal slot 695, up recess 665 and out U-shaped slot
670)
along a tortuous path. See Fig. 83.
However, it has been found that it is often challenging to thread a suture
through a narrow opening (e.g., through recess 665 and through U-shaped slot
670) without employing a suture threader (not shown). A suture threader is
well
known in the field of sutures and medical devices utilizing sutures, and
generally
comprises a substantially resilient device (e.g., a flexible wire) which can
be
passed through the narrow opening and then used to draw the suture back
through
the opening (e.g., by passing the suture through an opening in the suture
threader,
and then pulling the suture threader, including the suture, back through the
narrow
opening).
Thus it would be desirable to provide a suture anchor which facilitates
loading a suture into the suture anchor, and which avoids the need for using a
separate suture threader, and which facilitates quick and easy loading of a
suture
through the tortuous path of the suture anchor.
To this end, and looking now at Figs. 87-92, there is shown an alternative
novel anchor 615A. Anchor 615A is generally similar to the aforementioned
anchor 615 discussed above, however, anchor 615A is configured to facilitate
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simplified loading of a suture through anchor 615A, as will hereinafter be
discussed.
Anchor 615A preferably comprises a generally cylindrical body 625A
having a distal end 630A, a proximal end 635A and a generally circular side
wall
640A. Distal end 630A terminates in a flat or somewhat inclined distal end
surface 645A and a more inclined distal end surface 650A. Flat or somewhat
inclined distal end surface 645A is sufficiently large so as to render distal
end
630A of anchor 615A substantially blunt (but, where distal end surface 645A is
somewhat inclined, flat or somewhat inclined distal end surface 645A is
sufficient
to provide anchor 615A with a tapered lead-in). Inclined distal end surface
650A
is pitched at an appropriate angle (e.g., 30 degrees, 45 degrees, etc.) so as
to cause
anchor 615A to turn during deployment (i.e., in the same manner that the
aforementioned distal anchor 20 comprises a corresponding inclined distal
surface
60 for causing turning), as will hereinafter be discussed. Proximal end 635A
preferably terminates in an inclined proximal end surface 655A.
A vertical bore 660A passes completely through anchor 615A. Vertical
bore 660A preferably extends substantially perpendicular to the longitudinal
axis
of anchor 615A. Vertical bore 660A preferably intersects inclined distal end
surface 650A and is sized to slidably receive suture 620A therein. A recess
665A
is formed on one side of generally cylindrical body 625A and passes part way
through anchor 615A. Recess 665A preferably extends substantially
perpendicular to the longitudinal axis of anchor 615A. A U-shaped slot 670A is
formed on the opposite side of generally cylindrical body 625A (i.e., opposite
to
recess 665A) and passes part way through anchor 615A. U-shaped slot 670A
preferably extends substantially perpendicular to the longitudinal axis of
anchor
615A. Recess 665A and U-shaped slot 670A together define a flexible finger
675A which preferably extends distally within generally cylindrical body 625A.
In this form of the invention, a gap 680A is formed between the inner tip 685A
of
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flexible finger 675A and the edge 690A formed at the convergence of recess
665A and U-shaped slot 670A. Preferably gap 680A is sized so as to be
approximately 50% of the width of suture 620A when flexible finger 675A is in
its relaxed, unbiased condition (i.e., in the position shown in Figs. 87-92)
and
when suture 620A is in its normal, uncompressed condition. It should be
appreciated that recess 665A communicates with U-shaped slot 670A such that a
suture can be passed through generally cylindrical body 625A of anchor 615A,
as
will hereinafter be discussed. A bottom horizontal slot 695A preferably
extends
between vertical bore 660A and recess 665A. Bottom horizontal slot 695A may
be stepped, comprising a wider outer portion 700A and a narrower inner portion
705A. If desired, wider outer portion 700A may be sized to slidably receive
suture 620A therein so as to help keep anchor 615A and suture 620A from
binding when they are disposed within the aforementioned inserter 15, but
narrower portion 705A may be sized to snugly receive suture 620A therein
whereby to provide a light hold on suture 620A when suture 620A is disposed
therein. Alternatively, bottom horizontal slot 695A may comprise a slot of
uniform width with a chamfer lead-in.
A suture loading hole 730A is formed near the proximal end of U-shaped
slot 670A in the proximal portion of flexible finger 675A. More particularly,
a
portion of flexible finger 675A is cut away (e.g., so as to form a
hemicylindrical
cutout) near the proximal end of flexible finger 675A to form suture loading
hole
730A which passes through U-shaped slot 670A and into recess 665A. Suture
loading hole 730A is configured to be wider than gap 680A (i.e., wider than
the
gap between inner tip 685A of flexible finger 675A and edge 690A formed at the
convergence of recess 665A and U-shaped slot 670A) so as to facilitate passage
of the free end of suture 620A therethrough.
Note that, if desired, suture loading hole 730A may be formed in generally
cylindrical body 625A rather than in flexible finger 675A (i.e., a
hemicylindrical
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cutout may be formed in generally cylindrical body 625A rather than in
flexible
finger 675A); or suture loading hole 730A may be formed in both flexible
finger
675A and in generally cylindrical body 625A rather than in just flexible
finger
675A or in just generally cylindrical body 625A (i.e., hemicylindrical cutouts
may
be formed in both flexible finger 675A and in generally cylindrical body 625A
rather than in just flexible finger 675A or in just generally cylindrical body
625A).
Suture 620A is generally the same as the aforementioned suture 620,
however, suture 620A preferably comprises a stiffened free end for
facilitating
threading of the free end through vertical bore 660A and through suture
loading
hole 730A, as will hereinafter be discussed in further detail. More
particularly, as
seen in Figs. 87-92, suture 620A has a distal end 710A terminating in a large
ball
or knot 715A, a proximal segment 720A, and an intermediate loop 725A which
may be releasably secured to suture sled 280 of inserter 15. Suture 620A is
passed through anchor 615A so that large ball or knot 715A is disposed against
the more inclined distal end surface 650A, and the suture extends into
vertical
bore 660A, loops around to form loop 725A (which is preferably releasably
secured to suture sled 280 of inserter 15) and extends back down vertical bore
660A, through wider outer portion 700A of bottom horizontal slot 695A (if
bottom horizontal slot 695A is stepped), and up through suture loading hole
730A. It will be appreciated that inasmuch as suture loading hole 730A
comprises a diameter slightly larger than the diameter of suture 620A, suture
loading hole 730A facilitates easy passage of suture 620A through recess 665A
and out U-shaped slot 670A.
After suture 620A has been threaded through suture loading hole 730A,
the suture is pulled distally so as to lodge suture 620A in gap 680A between
inner
tip 685A of flexible finger 675A and edge 690A formed at the convergence of
recess 665A and U-shaped slot 670A. Note that inasmuch as suture 620A has a
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diameter which is approximately twice the size of gap 680A formed between
inner tip 685A of flexible finger 675A and edge 690A of anchor 615A, flexible
finger 675A will normally bear against the suture disposed in gap 680A. In
this
condition, the presence of the "oversized" suture 620A in the "undersized" gap
680A will cause flexible finger 675A to be flexed upwardly (from the angle of
view of Fig. 87) so as to accommodate suture 620A, with inner tip 685A of
flexible finger 675A capturing the suture against edge 690A of anchor 615A.
Note that some compression of suture 620A may occur in this condition.
In addition to the foregoing, it should be appreciated that suture 620A
follows a non-linear path through anchor 615A, and this non-linear path
creates
impedance to the passage of suture 620A through anchor 615A.
It should be appreciated that while suture 620A is preferably formed with
a stiffened free end in order to facilitate passage of the free end of the
suture
through vertical bore 660A and/or through suture loading hole 730A, the
stiffened
free end may be omitted, and/or, if desired, a suture threader may be passed
through suture loading hole 730A, used to grasp suture 620A, and then used to
pull suture 620A through suture loading hole 730A.
It will be appreciated that novel anchor 615A and suture 620A together
form a single anchor system 600A, and single anchor system 600A may be used
2 0 (e.g., with the aforementioned inserter 15) to secure an object (e.g.,
a sensory
nerve stimulator SNS lead 605) to tissue (e.g., fascia 610) in substantially
the
same manner that single anchor system 600 (and the aforementioned inserter 15)
may be used.
Inserter With Alternative Stop
As discussed above, it is generally desirable to provide inserter 15 with a
stop (e.g., removable stop 315, Figs. 27 and 27A) to prevent thumb button 310
from being inadvertently actuated. In one form of the invention, inserter 15
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comprises the aforementioned removable stop 315 which is removably mounted
to the shaft of thumb button 310 between the proximal end of handle 200 and
thumb button 310. When it is desired to actuate thumb button 310, removable
stop 315 is removed from the shaft of thumb button 310 so as to allow thumb
button 310 to move distally. However, it has been found that it is sometimes
desirable to allow movement of thumb button 310 and then thereafter prevent
movement of thumb button 310, and/or to provide a stop which does not require
a
removable component.
To this end, and looking now at Figs. 93-97, there is provided an
alternative stop 735 which may be incorporated into handle 200 and thumb
button
310. Stop 735 generally comprises a distally-extending member 740 which is
mounted to (or formed integral with) thumb button 310 and extends distally
therefrom. When thumb button 310 is in its unbiased proximal position, the
distal
end of member 740 of stop 735 contacts proximal end 240 of handle 200. In one
preferred form of the invention, the distal end of member 740 comprises a seat
742 disposed between a pair of distally-extending fingers 745 (Fig. 95) for
engaging a tab 750 mounted to proximal end 240 of handle 200 (Fig. 95).
In this form of the invention, handle 200 preferably has a non-circular
cross-section, comprising a recessed flat 752.
When it is desired to actuate thumb button 310, thumb button 310 is pulled
proximally to release seat 742 from engagement with tab 750 (i.e., by moving
seat
742 proximally such that seat 742 no longer contacts tab 750), and thumb
button
310 is rotated 180 degrees (i.e., along an arc 755) so that member 740 is
arcuately
aligned with recessed flat 752 of handle 200. See Fig. 96. As this occurs,
distally-extending member 740 of stop 735 no longer contacts proximal end 240
of handle 200 and distally-extending member 740 is able to move distally along
one side of handle 200 (i.e., along recessed flat 752). If it is desired to
thereafter
re-engage stop 735, thumb button 310 can be again pulled proximally and then
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rotated 180 degrees so that seat 742 of distally-extending member 740 is
aligned
with tab 750 of handle 200, such that seat 742 will re-engage tab 750 if thumb
button 310 should be moved distally.
In another form of the invention, and looking now at Fig. 98, an
alternative stop 760 may be provided. Stop 760 comprises a tab 765 which is
hingedly mounted to thumb button 310. Tab 765 comprises a cutout 770 for
releasably engaging the shaft of thumb button 310 as tab 765 is swung toward
the
shaft of thumb button 310. In this manner, tab 765 can be selectively
interposed
between the head of thumb button 310 and proximal end 240 of handle 200,
whereby to prevent undesired actuation of thumb button 310.
When it is desired to actuate thumb button 310, tab 765 is swung radially
away from the shaft of thumb button 310, cutout 770 disengages from the shaft
of
thumb button 310 and the body of tab 765 is no longer interposed between
proximal end 240 of handle 200 and the head of thumb button 310, whereby to
allow thumb button 310 to be actuated as desired. If it is thereafter desired
to lock
thumb button 310 against actuation, tab 765 can be swung inwardly such that
cutout 770 re-engages the shaft of thumb button 310 and is re-interposed
between
thumb button 310 and proximal end 240 of handle 200.
Modifications Of The Preferred Embodiments
It should be understood that many additional changes in the details,
materials,
steps and arrangements of parts, which have been herein described and
illustrated
in order to explain the nature of the present invention, may be made by those
skilled in the art while still remaining within the principles and scope of
the
invention.
