Note: Descriptions are shown in the official language in which they were submitted.
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TISSUE FIXATION SYSTEM TO GRASP, RETAIN AND RELEASE TISSUE
BACKGROUND
[0001] The present disclosure includes examples of tissue fixation devices.
Specifically, the
tissue fixation devices described herein may be used with a uterine
manipulator to grasp, retain and
release cervical tissue. It will be appreciated that the disclosed embodiments
may have applications
outside of uterine manipulation, and may be used on other bodily tissues.
[0002] In some surgical procedures, it is desirable to control the position
and orientation of an
organ, such as a uterus, to help the surgeon operate on the uterus or on other
parts of the body
adjacent to the uterus. Uterine manipulator devices can be used to position
and orient a uterus
during surgery. U.S. Patent Application Publication No. US2012/0109147
discloses an example
uterine manipulator system. Typical uterine manipulator systems consist of a
bell-housing or cup
shaped member that fits around the cervix and a rod member that is inserted
through the cervix and
into the uterus. The bell housing can be sized and shaped to compress the
cervical tissue against the
rod member to help the surgeon grasp the cervix and manipulate the position
and orientation of the
uterus. The bell housing can also provide a cutting guide to facilitate
incision placement, for
example colpotomy incisions and incisions requiring a safe distance from the
ureters and uterine
arteries. However, if the cervical tissue fixation within the bell housing is
insufficient, a uniform
colpotomy incision is difficult to achieve. Furthermore, the risk of damaging
surrounding tissues,
such as the ureters and uterine arteries, will increase if the tissue fixation
is insufficient. The
compressive forces imparted to the cervical tissue between the bell housing
and the rod member are
usually not sufficient enough to tightly grasp the cervix and ensure safe
incision placement.
Accordingly, it has been known to include a balloon in combination with the
rod member which can
be inflated inside of the uterus to provide additional pressure on the
cervical tissue between the
balloon and the bell housing to force the cervical tissue down into the bell
housing and increase the
gripping force of the bell housing on the cervix. However, the internal
balloon may not create
optimal tissue fixation, especially in patients with anatomical abnormalities,
rigid tissues, scar
tissue, and the like. Additionally, the balloon may leak or become
accidentally "nicked" by other
surgical instruments during the surgical procedure. This may result in loss of
tissue fixation that
can delay and complicate surgical incisions and/or removal of the uterus
through the vagina in the
case of a hysterectomy procedure. Moreover, it may not be desirable to use a
balloon inside of a
uterus containing cancerous cells, because the cancerous cells can be broken
loose by the balloon
and spread to other parts of the body. Sufficient tissue fixation is typically
not achieved with a
balloon, as is evidenced by workarounds currently used by many surgeons. For
example, surgeons
are known to use adjunctive stitches through the cervix which are then tied to
the instrument to
increase tissue fixation. This workaround adds additional steps to the surgery
and further
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complicates things by making it difficult to quickly remove the bell housing
and/or uterine
manipulator from the patient if an emergency situation arises, such as the
need to defibrillate the
patient's heart.
[0003] Accordingly, it is desirable to provide a device that achieves
reliable tissue fixation, with
or without a balloon, that will last throughout the entire surgical procedure
and that will not be
compromised by rigid tissue, anatomical abnormalities, scar tissue, cancerous
tissue, or the like. In
some cases, it may also be desirable to generate tissue fixation close to
certain incision sites, such as
the colpotomy incision site, to increase the control, placement and precision
of the incision. It is
also desirable to provide a device that employs a simple actuation mechanism
to quickly and easily
engage and disengage the tissue fixation mechanism during surgery.
[0004] An example of the present technology disclosed herein includes a
tissue fixation
assembly shaped to be attached to a uterine manipulator. The assembly includes
a housing, a
fixation member carriage with deployable fixation members, and a cap. The
fixation member
carriage and fixation members are captured between the housing and the cap. In
one example, a
suture is attached to the fixation member carriage and is actuatable to move
the fixation member
carriage to deploy or retract the fixation members. The assembly may be
inserted into a vagina and
receive cervical tissue within the housing. The fixation members may then be
deployed inwardly
from the housing to grip the cervical tissue. The fixation members may also be
locked in the
deployed position to maintain the grip on the tissue. The fixation members may
also be easily
retracted to release the tissue and remove the device as needed.
[0005] Those of skill in the art will recognize that the following
description is merely
illustrative of the principles of the disclosure, which may be applied in
various ways to provide
many different alternative embodiments and may be applicable outside the
fields of surgery or
medical devices. While the present disclosure is made in the context of tissue
fixation related to the
cervix, for the purposes of illustrating the concepts of the design, it is
contemplated that the present
design and/or variations thereof may be suited to other uses for grasping any
bodily tissue.
Moreover, the devices and methods set forth herein may be used in open,
percutaneous, and/or
minimally invasive procedures.
[0006] All changes which come within the meaning and range of equivalency
of the claims are
to be embraced within their scope.
[0007] Standard medical planes of reference and descriptive terminology are
employed in this
specification. A sagittal plane divides a body into right and left portions. A
mid-sagittal plane
divides the body into equal right and left halves. A coronal plane divides a
body into anterior and
posterior portions. A transverse plane divides a body into superior and
inferior portions. Anterior
means toward the front of the body. Posterior means toward the back of the
body. Superior means
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toward the head. Inferior means toward the feet. Medial means toward the
midline of the body.
Lateral means away from the midline of the body. Axial means toward a central
axis of the body.
Abaxial means away from a central axis of the body. Ipsilateral means on the
same side of the
body. Contralateral means on the opposite side of the body. These descriptive
terms may be applied
to an animate or inanimate body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Various embodiments of the present disclosure will now be discussed
with reference to
the appended drawings. It will be appreciated that these drawings depict only
typical examples of
the present disclosure and are therefore not to be considered limiting of its
scope.
[0012] FIG. 1 is a perspective view of a tissue fixation device according
to one example of the
present disclosure having a housing, a cap, and deployable fixation members;
[0013] FIG. 2 is a side view of the tissue fixation device of FIG. 1;
[0014] FIG. 3A is a top view of the tissue fixation device of FIG. 1 with
the fixation members
in a retracted position; FIG. 3B is a top view of the tissue fixation device
of FIG. 1 with the fixation
members in a deployed position;
[0015] FIG. 4 is an exploded view of the tissue fixation device of FIG. 1;
[0016] FIG. 5 is a top exploded view of the tissue fixation device of FIG.
1;
[0017] FIG. 6 is a bottom exploded view of the tissue fixation device of
FIG. 1;
[0018] FIG. 7A is a top view of the housing and fixation member carriage
assembly of the
tissue fixation device of FIG. 1 with the fixation members in a retracted
position and dashed lines
indicating suture paths under the fixation member carriage assembly; FIG. 7B
is a top view of the
housing and fixation member carriage assembly of the tissue fixation device of
FIG. 1 with the
fixation member in a deployed position;
[0019] FIG. 8 is a side cross-sectional view of the tissue fixation device
of FIG. 1 with the
fixation members in a retracted position, taken along section line 8-8 in FIG.
7A;
[0020] FIG. 9 is a perspective view of another tissue fixation device in
accordance with the
present disclosure with the tissue fixation members in the deployed
configuration;
[0021] FIG. 10 is a perspective view of the tissue fixation device of FIG.
9 with the tissue
fixation members in the retracted configuration;
[0022] FIG. 11 is an exploded view of the tissue fixation device of FIG. 9;
[0023] FIG. 12 is a perspective view of another tissue fixation device in
accordance with the
present disclosure with the tissue fixation member in the deployed
configuration;
[0024] FIG. 13 is a perspective view of the tissue fixation device of FIG.
12 with the tissue
fixation member in the retracted configuration;
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[0025] FIG. 14 is a perspective view of another tissue fixation device in
accordance with the
present disclosure with the tissue fixation members in the deployed
configuration;
[0026] FIG. 15 is a perspective view of the tissue fixation device of FIG.
14 with the tissue
fixation members in the retracted configuration;
[0027] FIG. 16 is a perspective view of another tissue fixation device in
accordance with the
present disclosure with the tissue fixation members in the deployed
configuration;
[0028] FIG. 17 is another perspective view of the tissue fixation device of
FIG. 16 with the
tissue fixation members in the deployed configuration;
[0029] FIG. 18 is a perspective view of the tissue fixation device of FIG.
16 with the tissue
fixation members in the retracted configuration;
[0030] FIG. 19 is a perspective view of another tissue fixation device in
accordance with the
present disclosure with the tissue fixation members in the deployed
configuration;
[0031] FIG. 20 is a perspective view of the tissue fixation device of FIG.
19 with the tissue
fixation members in the retracted configuration;
[0032] FIG. 21 is a perspective view of a tissue fixation device having a
cap attached by a snap
fit, the device in a deployed configuration;
[0033] FIG. 22 is a top-down view of the tissue fixation device of FIG. 21;
[0034] FIG. 23 is an exploded view of the tissue fixation device of FIG. 21
showing a housing,
fixation member carriage, fixation members, and cap of the device;
[0035] FIG. 24 is a perspective view of the cap of FIG. 23;
[0036] FIG. 25 is a side cross-sectional view of the tissue fixation device
of FIG. 21;
[0037] FIG. 26 is a perspective view of a tissue fixation device having a
cap attached by a
twisting fit, the device in a deployed configuration;
[0038] FIG. 27 is a top-down view of the tissue fixation device of FIG. 26;
[0039] FIG. 28 is an exploded view of the tissue fixation device of FIG. 27
showing a housing,
fixation member carriage, fixation members, and cap of the device;
[0040] FIG. 29 is a perspective view of the cap of FIG. 28;
[0041] FIG. 30 is a side cross-sectional view of the tissue fixation device
of FIG. 26;
[0042] FIG. 31A is a perspective view of another embodiment of a tissue
fixation device having
a housing, a fixation member carriage assembly and a cap, with tissue fixation
members in a
retracted configuration; FIG. 31B is a perspective view of the device of FIG.
31B with the tissue
fixation members in a deployed configuration; FIG. 31C is a side view of the
device of FIG. 31A;
[0043] FIG. 32 is an exploded view of the device of FIG. 31A;
[0044] FIG. 33 is a perspective view of a cap of the device of FIG. 31A;
[0045] FIG. 34 is a side cross-sectional view of the tissue fixation device
of FIG. 31A;
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[0046] FIG. 35A is an inferior view of the cap and fixation members of the
device of FIG. 31A;
FIG. 35B is an inferior view of the cap and fixation members of the device in
the configuration of
FIG. 32A;
[0047] FIG. 36A is a superior view of a housing, carriage assembly and
sutures of the device of
FIG. 31A; FIG. 36B is a superior view of the housing, carriage assembly and
sutures in the
deployed configuration of FIG. 32A; dashed lines indicate the approximate
paths of the sutures in a
passage between the carriage assembly and the housing;
[0048] FIG. 37A is a top-down view of a fixation member captured in a
fixation member
carriage; FIG. 37B is a partial side cross sectional view of the fixation
member carriage and fixation
member of FIG. 37A and the cap of FIG. 31A;
[0049] FIG. 38A is a perspective partial view of a fixation member carriage
with a capture
feature; FIG. 38B is an exploded view of the fixation member and the fixation
member carriage of
FIG. 38A;
[0050] FIG. 39 is a side partial cross sectional view of a fixation member
captured in a fixation
member carriage;
[0051] FIG. 40A is a side view of a needle, the needle curving into the
page; FIG. 40B is a top
view of the needle of FIG. 40A; FIG. 40C is a side cross-sectional view of the
needle of FIG. 40A
captured in a needle carriage;
[0052] FIG. 41 is a partial perspective view of a needle captured in a
needle carriage;
[0053] FIG. 42A is a perspective view of a needle carriage having several
pins; FIG. 42B is a
partial view of a needle mounted to the carriage of FIG. 42A; FIG. 42C is a
top view of the needle
of FIG. 42B; FIG. 42D is a side view of the needle of FIG. 42B;
[0054] FIG. 43A is a side view of a needle; FIG. 43B is a transverse cross
section of the needle
of FIG. 43A taken along line A-A
[0055] FIG. 44 is a partial side view of a needle captured in a carriage;
[0056] FIG. 45A is a top view of a carriage with a plurality of needles and
capture features;
FIG. 45B is a top view of a needle of FIG. 45A; FIG. 45C is a perspective view
of a retention block;
[0057] FIG. 46A is a perspective exploded view of a needle carriage
assembly; FIG. 46B is a
top view of the needle of FIG. 46A; FIG. 46C is a partial side cross-sectional
view of the needle
carriage assembly of FIG. 46A;
[0058] FIG. 47A is a top view of a needle; FIG. 47B is a side view of the
needle of FIG. 47A;
FIG. 47C is a perspective view of a needle carriage having a capture feature;
FIG. 47D is a partial
view of the needle of 47A mounted to the carriage of FIG. 47C by a pin;
[0059] FIGS. 48A, 48B and 48C are various views of a needle; FIG. 48D is a
perspective view
of the needle of FIG. 48A-48C captured in a carriage;
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[0060] FIG. 49A is a side view of a needle; FIG. 49B is a transverse cross
section of the needle
of FIG. 49A taken along line B-B;
[0061] FIG. 50 is a perspective view of another carriage and needles
stamped from a single
piece of material;
[0062] FIG. 51 is a perspective view of another carriage and needles
stamped from a single
piece of material;
[0063] FIG. 52 is a top view of a carriage with several needles overmolded
into the carriage;
[0064] FIG. 53 is a perspective view of a carriage with needles mounted in
slots in the carriage;
[0065] FIG. 54 is a top view of a flexible needle captured in a carriage;
[0066] FIG. 55 is a top view of a needle carriage with needles overmolded
into the carriage,
hinges formed between the needles and the carriage;
[0067] FIG. 56 is a partial top view of a carriage, a needle, and suture
for deploying the needle;
[0068] FIG. 57 is a partial top view of a carriage and a plurality of
straight needles;
[0069] FIG. 58 is a perspective view of a carriage and an expandable
capture member;
[0070] FIG. 59A is a side cross-sectional view of a tissue fixation device
with two needles; FIG.
59B is a perspective view of the needles and a carriage of FIG. 59A; and
[0071] FIG. 60 is a perspective view of a tissue fixation device having
needles with compound
curvature.
DETAILED DESCRIPTION
[0072] While certain embodiments are shown and described in detail below by
way of
illustration only, it will be clear to the person skilled in the art upon
reading and understanding this
disclosure that changes, modifications, and variations may be made and remain
within the scope of
the technology described herein. Furthermore, while various features are
grouped together in the
embodiments for the purpose of streamlining the disclosure, it is appreciated
that features from
different embodiments may be combined to form additional embodiments which are
all
contemplated within the scope of the disclosed technology.
[0073] Not every feature of each embodiment is labeled in every figure in
which that
embodiment appears, in order to keep the figures clear. Similar reference
numbers (for example,
those that are identical except for the first numeral) may be used to indicate
similar features in
different embodiments.
[0074] Any of the devices described herein may be fabricated from metals,
alloys, polymers,
plastics, ceramics, glasses, composite materials, or combinations thereof,
including but not limited
to: titanium, titanium alloys, commercially pure titanium grade 2, ASTM F67,
Nitinol, cobalt
chrome, stainless steel, UHMWPE, PEEK, and biodegradable materials, among
others. Different
materials may be used within a single part. The devices disclosed herein may
also encompass a
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variety of surface treatments or additives, including but not limited to: anti-
microbial additives,
analgesics, anti-inflammatories, etc. Any device disclosed herein may include
a radiographic
marker for imaging purposes. Any device disclosed herein may be color-coded or
otherwise marked
to make it easier for the surgeon to identify the type and size of the device.
[0075] In a first aspect of the disclosure, a tissue fixation device
includes a housing having an
inner space configured to receive tissue therein and an enclosed section,
wherein the enclosed
section completely encloses at least one planar surface; and at least one
fixation member movable
between a retracted configuration and a deployed configuration, wherein when
the at least one
fixation member is in the deployed configuration, the at least one fixation
member protrudes into
the inner space, and wherein when the at least one fixation member is in the
retracted configuration,
the at least one fixation member is retracted relative to the inner space.
Various embodiments of the
tissue fixation device can include one or more of the following attributes:
[0076] In an embodiment, the tissue fixation device can further include a
fixation member
carriage engaged with the at least one fixation member and configured to move
the at least one
fixation member between the deployed configuration and the retracted
configuration.
[0077] In an embodiment, the housing and the fixation member carriage are
substantially
circular, and rotational movement of the fixation member carriage along a
circle defined by the
housing moves the at least one fixation member between the retracted and
deployed configurations.
[0078] In an embodiment, the at least one fixation member is curved, and
the diameter of the
curvature of the at least one fixation member is less than the diameter of the
circle.
[0079] In an embodiment, the tissue fixation device can further include a
cap detachable from
the housing, wherein the fixation member carriage is captured between the cap
and the housing.
[0080] In an embodiment, the tissue fixation device can further include a
plurality of tabs and a
plurality of slots, wherein the tabs are received in the slots to attach the
cap to the housing.
[0081] In an embodiment, the tissue fixation device can further include a
first line and a second
line, the first and second lines connected to the fixation member carriage,
wherein pulling the first
line moves the fixation member carriage in a first direction to deploy the at
least one fixation
member, and wherein pulling the second line moves the fixation member carriage
in a second
direction to retract the at least one fixation member.
[0082] In an embodiment, the at least one fixation member is deployed
inwardly toward a
lengthwise central axis of the housing in a plane substantially perpendicular
to the lengthwise
central axis.
[0083] In an embodiment, the at least one fixation member has a sharp point
capable of piercing
tissue.
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[0084] In an embodiment, the at least one fixation member is curved with an
arch shape that
substantially lies in a single plane.
[0085] In an embodiment, the at least one fixation member is connected to
the fixation member
carriage by a hinge type connection, about which the fixation member pivots.
[0086] In an embodiment, the at least one fixation member is deflected by
the cap as it moves to
the deployed configuration.
[0087] In an embodiment, the tissue fixation device includes three fixation
members, each of
the three fixation members being substantially coplanar with each other.
[0088] In an embodiment, the at least one fixation member is helically
shaped.
[0089] In an embodiment, the housing is frustoconical in shape.
[0090] FIGS. 1-8 illustrate one example of a tissue fixation device 10. The
tissue fixation
device 10 can include a housing 12, a cap 14, and a fixation member carriage
assembly 16 (shown
first in FIG. 4) which carries at least one fixation member 18. In some
examples, the fixation
member 18 may be a needle. The fixation member carriage assembly 16 can be
captured between
the housing 12 and cap 14, and may be rotatable within a track 26 (FIG. 4)
formed in the housing 12
and/or the cap 14. It is appreciated that in other embodiments, the cap 14 may
be integral with the
housing 12 and not formed as a separate element.
[0091] The cap 14 and housing 12 may be referred to as a bell cap or a bell
housing, as they
may form a bell shape in some examples. In some examples, the housing 12 can
have at least one
enclosed section that completely encloses at least one planar surface. The at
least one planar
surface can be defined by a cross-sectional plane through the housing that
results in a planar surface
that is completely enclosed or surrounded by a portion of the housing. In
other words, the planar
surface is an empty plane that is completely bounded by the housing 12. For
example, with
reference to FIG. 2, if a cross section of the housing 12 is taken
perpendicular to the longitudinal
central axis 35 and through the top portion of the housing, or the cap 14, a
circular planar surface
would be created which lies within the opening, or inner space 33 of the
housing 12 and which is
completely bounded by or surrounded by the housing 12 or cap 14. On the other
hand, if the
perpendicular cross-sectional plane were moved lower on the housing to where
it crosses the struts
22, housing inner space 33, and windows 23, then this would result in a planar
surface that is not
completely bounded on all sides, or surrounded by the housing 12 because the
windows 23 are
open.
[0092] In other examples, the housing 12 may not have at least one enclosed
section. In these
examples there may be discontinuities or breaks in the housing (not shown) of
any size or shape. In
these examples, the at least one fixation member can be deployed away from an
inner surface 42 of
the housing and into the opening, or inner space 33 to grip tissue. The at
least one fixation member
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can be also be retracted away from the opening toward an inner surface of the
housing to release the
tissue.
[0093] Referring to FIGS. 3A and 3B, the device can be actuable between a
fixation member 18
retracted configuration, and a fixation member 18 deployed configuration. From
the top or bottom
perspective, the device can be radially symmetric. The embodiment shown in
FIGS. 1-8 includes
three curved fixation members 18. It will be appreciated that other
embodiments may include more
or fewer fixation members 18.
[0094] Referring to FIGS. 4 and 5, housing 12 can be substantially circular
or cylindrical in
shape. However, the housing 12 can also be conical, frustoconical, funnel,
ovoid, or polygonal in
shape, or any combination of shapes thereof. The shape of the housing is not
as important as the
ability of the housing to enclose tissue to be grabbed by one or more fixation
members, as will be
apparent from the present disclosure. Continuing with FIGS. 4 and 5, housing
12 may include an
attachment portion 20 which may be shaped to connect to a uterine manipulator
(not shown). A
plurality of struts 22 can project superiorly from the attachment portion 20
and terminate at a
carriage support 24. Windows 23 may be interspersed between the struts 22.
However, in other
embodiments, the housing may not include struts 22 or windows 23. The carriage
support 24 can
be ring-shaped, and include a carriage track 26, which may be substantially
circular. An outer rim
28 can circumscribe the outer diameter of carriage track 26, and a step 30 may
be formed
intermediate the track 26 and the outer rim 28. One or more apertures 32 can
open through the
carriage support 24, and may pass through at least a portion of the outer rim
28 and step 30. A
housing inner wall 34 can circumscribe the inner diameter of the carriage
track 26, and may include
a plurality of discontinuations, or wall gaps 36. At least one edge 38 of each
wall gap 36 may be
beveled. When operatively assembled, the fixation members 18 are deployable
through the wall
gaps 36; the beveled edges 38 may promote smooth deployment of the fixation
members 18 and
prevent the fixation members 18 from hanging up or being caught in the wall
gaps 36.
[0095] Housing 12 may be generally stepped in outer profile, wherein the
carriage support 24
has the widest outer diameter, struts 22 form a circle of intermediate
diameter, and attachment
portion 20 has the narrowest outer diameter (FIG. 2). The inner wall 34,
struts 22, and attachment
portion 20, may surround and define a housing inner space 33. A lengthwise
central axis 35 may
extend through the housing inner space 33, also defined by the inner wall 34,
struts 22, and
attachment portion 20. The number and width of struts 22 and windows 23 may
vary, and in some
embodiments the housing 12 may be formed as a continuous piece extending
between the
attachment portion 20 and the carriage support 24, with no struts 22 or
windows 23 present. The
embodiment depicted in FIGS. 1-8 is generally bell shaped; however in other
embodiments the
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housing 12 and/or the device 10 may have a cylindrical shape and may include a
tapered portion at
either end. In other embodiments the device 10 may be cup or bowl shaped, or
polygonal.
[0096] Cap 14 may have a ring-shape, and may include an outer side 40
opposite an inner side
42. An outer surface 44 (FIG. 5) of the outer side 40 may be positioned as an
upper surface, and
may include a plurality of steps, ridges and/or grooves which may facilitate
gripping and
manipulating the cap 14. As seen in FIG. 6, the inner side 42 may have
circular outer and inner
diameters. A cap inner wall 43 forms the inside diameter of the cap 14, and
may include a plurality
of tabs 46 which project inferiorly from the inner wall 43. Each tab 46 may
include at least one
beveled edge 48. A cap outer wall 50 may extend inferiorly, intermediate to
and adjoining cap inner
wall 43 and cap outer wall 50 and form a track cover 52. A plurality of cap
bosses 54 can project
inwardly from the cap outer wall 50. Each cap boss 54 may include a ramp
feature 56 which urges
the fixation member 18 inward as it is deployed. The cap 14 can also have
beveled edges 48 which
can also help urge the fixation member 18 inward as it is deployed. Cap outer
wall 50 can include a
plurality of recessed alcoves 58 which allow space for the curved fixation
members 18 to be
retained within the cap outer wall 50 when the fixation members 18 are in the
retracted position.
Housing 12 and cap 14 may be formed of plastic, or other materials listed
herein.
[0097] Fixation carriage assembly 16 can include a generally circular
fixation carriage 60. A
plurality of mounting features 62 can project superiorly from the fixation
carriage 60. Each
mounting feature 62 may include a recess 64 through which an opening 66 is
formed. Openings 66
can be sized to allow passage of a suture 90. Each mounting feature 62 can
further include a
fixation member mount 68. In the embodiment shown, fixation member mount 68
includes two pin
holes 70 through which a mounting pin 72 passes. Fixation member carriage 60
can have a first or
superior side 74 and a second or inferior side 76. A circular setback or
groove 78 can be formed on
the inferior side 76, and be sized to receive a suture.
[0098] Each fixation member 18 can be curved, rigid, and may terminate at a
beveled point. The
rigid fixation members may be formed of stainless steel, or other materials
disclosed herein. Other
embodiments may include flexible fixation members, which may be straight or
curved, and may be
made of Nitinol, for example. The fixation member curvature may be non-
concentric with the
curvature of the carriage track 26, for example the fixation member curvature
may have a smaller
diameter than the diameter of the carriage track (FIG. 7A). Each fixation
member 18 may include a
base portion 80, a shaft 82, and a point 84, which may also be referred to as
a tip. The point 84 may
be sharpened and/or serrated in order to reduce the forces necessary to pierce
the tissue, or deploy
the fixation member. Any of the fixation members disclosed herein may also
include a sharp tip or
point for the same purpose. The fixation member 18 may have an arch shape that
lies substantially
in a single plane in some examples, in other examples, the fixation member can
be substantially
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straight. In yet further examples, the fixation member can have a curved shape
in multiple planes or
in an infinite number of planes. When assembled into the fixation member
carriage assembly 16,
base portion 80 is received in fixation member mount 68, and a mounting pin 72
may pass through
the fixation member mount 68 and base portion 80 to form a hinge type
connection, about which the
fixation member 18 may pivot.
[0099] Referring to FIGS. 7A, 7B, and 8, fixation member carriage assembly
16 may be
mounted in the upper portion of housing 12, such that fixation member carriage
60 is received in
carriage track 26. A line passage or suture passage 86 may be formed between
the groove 78 and
outer rim 28. A first line, or suture 90 may be threaded through one opening
66, along suture
passage 86 in a first direction 100 and through one aperture 32. A knot 92 may
be formed in the
suture end remaining at opening 66, the knot residing in recess 64 immediately
adjacent opening 66,
and the knot preventing withdrawal of the first suture through the opening 66.
A second suture 94
may be threaded through a second opening 66, along suture passage 86 in a
second direction 102
opposite the first direction, and through another aperture 32. The second
suture 94 may also be
knotted, forming knot 96 to prevent withdrawal. In another example, the first
line 90 and/or second
line 94 may be secured in one or more crimp tubes which reside in openings 66,
the crimp tube(s)
preventing withdrawal of the first and/or second suture through the
corresponding opening 66.
When the first and second sutures are thus placed, pulling on the first suture
90 will pull the fixation
member carriage assembly 16 in the first direction 100, and pulling on the
second suture will pull
the fixation member carriage assembly 16 in the second, or opposite, direction
102. The sutures 90,
94 may be replaced by another type of line, flexible member, rigid member,
filament, braid, yarn,
cable, wire, chain, strap, lacing, or the like.
[00100] In an alternative threading embodiment, a single suture can be used. A
first end of the
suture is passed down through one opening 66, along suture passage 86 and out
one aperture 32.
The first end is then passed partially around the housing 12, up into a second
aperture 32, along
suture passage 86 and up through a second opening 66. The suture is knotted at
both of the openings
66, and a length of suture is left along the housing 12, between the two
openings 32. With this
threading, pulling on the first end of the length of suture will pull the
fixation member carriage
assembly 16 in one direction, and pulling on the second end of the length of
suture will pull the
fixation member carriage assembly 16 in the opposite direction.
[00101] The sutures or portions of the sutures may be color-coded. For
example, the first suture
may be colored green and the second suture may be colored red; of course any
color scheme may be
used so long as the sutures are visually distinct. Similarly, if one suture is
used, different portions of
the one suture may be color coded differently. In one example, the green color
may be used to
indicate that pulling on the green suture (or green portion) will deploy the
fixation members and the
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red color may be used to indicate that pulling on the red suture (or red
portion) will retract the
fixation members. Also, portions of the suture(s) may be colored to a specific
length in order to be
used as visual indicators to show when the fixation members are fully deployed
or retracted. For
example, if all the red color is hidden because it has been drawn into the
suture passage 86, that
may provide indication that the fixation members are fully deployed. In some
examples, only one
suture, or one portion thereof, may be colored, a second portion or a second
suture retaining its
natural color.
[00102] In other embodiments, one or more sliding tabs, levers or other
actuation features may
be used instead of the sutures to move the fixation member carriage and/or
deploy the one or more
fixation members. The actuation features may push, pull, twist, or otherwise
urge movement of the
fixation member carriage and/or fixation members.
[00103] When the cap 14 is fitted to the housing 12, tabs 46 may fit into wall
gaps 36, although
inferior to each tab 46 an open portion of each gap can remain, the open
portion sized to permit
passage of the fixation member tip 84 and shaft 82. Fixation member carriage
assembly 16 can thus
be captured in an enclosure formed between the carriage track 26 and track
cover 52. When the
tissue fixation device 10 is in the retracted configuration, each fixation
member 18 is substantially
contained in a fixation member retention space 88 bounded by fixation member
carriage 60, track
cover 52, housing inner wall 34 and cap outer wall 50. In this configuration,
each fixation member
tip 84 is adjacent to, but not extending beyond, a wall gap 36. To move the
device 10 into the
deployed configuration, the appropriate suture is pulled, for example suture
90, and fixation
member carriage assembly 16 will be pulled along carriage track 26 in
direction 100. As the
carriage assembly 16 travels along the circle defined by the housing, carrying
fixation members 18,
fixation member tips 84 will encounter ramp features 56 of bosses 54 and be
forced, or deflected,
through the open portions of wall gaps 36, thus being inwardly deployed. It is
appreciated that a
single movement, for example, pulling the suture 90, may deploy some or all of
the fixation
members simultaneously. The deployment paths of fixation members 18 may be
coplanar in some
embodiments, and the fixation members 18 may be deployed along a plane
perpendicular to a
lengthwise central axis 35 of the housing 12. The plane may also be described
as transverse to the
lengthwise central axis 35. The plane may also be coplanar with or parallel to
the planar surface
which is completely enclosed by the housing. When the fixation members 18 are
deployed into
tissue along paths transverse to the lengthwise central axis 35, this can
advantageously result in
fixing the position of the tissue within the housing 12, and preventing the
tissue from subsequently
translating relative to the device 10 along the lengthwise central axis. In
other words, gripping the
tissue from a lateral or transverse direction can prevent the tissue from
moving longitudinally
within, or even out of, the housing inner space 33.
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[00104] In other embodiments, the fixation members 18 may move up and/or down
out of a
plane perpendicular to a lengthwise central axis 35 of the housing 12. In
these embodiments, the
deployment paths of the fixation members 18 may be parallel to the central
housing axis, or at an
acute angle to the axis; the paths themselves may be nonlinear, curved,
helical, or the like.
[00105] The fixation members 18 may pierce tissue, such as cervical tissue,
positioned in the
housing inner space 33. Deployment can stop when the fixation member bases 80
become wedged
between housing inner wall 34 and cap ramp feature 56. Another stop to the
carriage motion may be
formed when mounting feature 62 of the carriage assembly 16 encounters cap
boss 54. Because of
the wedging engagement of the fixation member bases between the housing 12 and
cap 14, the
deployed fixation members can be locked in the deployed configuration and
remain deployed until
they are intentionally retracted.
[00106] The fixation member tips 84 can be shaped similar to a hypodermic
needle such that,
minimum penetration force is needed to deploy the fixation members 18 into the
tissue.
Furthermore, in this example, when the three fixation members 18 are fully
deployed, the fixation
members 18 can engage with over 280 degrees of tissue, creating strong tissue
fixation. Moreover,
this embodiment allows the fixation members 18 to be close to the outer
surface 44 of cap 14 which
may serve as a cutting guide during colpotomy incisions. This allows the
tissue fixation members to
be less than about 0.25 inches from the cutting guide and the interiorly
located fixation members 18
will not impinge on the cutting path. It will be appreciated that other size
cutting guide tip designs
can be made to adjust the distance and orientation of the cutting guide to
achieve different incision
placements as desired.
[00107] To move the device 10 into the retracted configuration, the second
suture 92 is pulled.
The fixation member bases 80 will be disengaged from the inner wall 34 and
ramp feature 56, and
fixation member carriage assembly 16 will be pulled in the opposite direction,
or direction 102. As
the carriage moves, the inner curved side of the shaft 82 of each fixation
member will be forced
outward as it encounters inner wall 34, and fixation members 18 will be
retracted in through wall
gaps 36.
[00108] FIGS. 9-20 show alternative embodiments of tissue fixation devices.
FIGS. 9-11 show a
tissue fixation device 110 having a housing 112, a cap 115, fixation member
carriage 116 and at
least two fixation members 114 which rotate into the deployed position in
opposite directions. In
this example, tissue fixation device 110 has four fixation members 114. Two of
the fixation
members rotate into the deployed position in the same direction and the other
two fixation members
rotate into the deployed position in the opposite direction; the second set of
fixation members is also
axially offset from the first set of fixation members. However, it will be
understood that more or
less fixation members 114 can be used in other embodiments without departing
from the spirit or
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scope of the present disclosure. Similar to the example of FIGS. 1-8, the
fixation members 114 can
have beveled tips 118 which interact with ramp features (not shown) to force
the fixation members
inward toward the tissue as the fixation members 114 rotate into the deployed
position, similar to
other embodiments disclosed herein. The cap 115 can also have beveled edges
156 which may also
help urge the fixation member 18 inward as it is deployed.
[00109] Operation of this tissue fixation device can be similar to that
described above with
reference to FIGS. 1-8, except that multiple fixation member carriages 116,
117 can be stacked on
top of each other, with each of the fixation member carriages 116, 117 being
free to rotate in
opposite directions. In this example, two fixation member carriages 116, 117
are used. However, in
other embodiments, more than two fixation member carriages can be used.
Actuation of the fixation
members 114 into the deployed position can be accomplished by any mechanical
means disclosed
herein. In one embodiment, a first suture (not shown) with one end split into
two suture portions, or
limbs, can be used with one of the split ends connected to the first fixation
member carriage 116 in
a first direction and the other split end connected to the second fixation
member carriage 117 in a
second direction. When the first suture is pulled, the two fixation member
carriages 116, 117 will
rotate in opposite directions relative to each other. A second suture (not
shown) with one end split
into two suture portions can be used to reverse the rotation of the two
fixation member carriages
with the split ends of the second suture connected to the fixation member
carriages 116, 117 in
opposite directions relative to the split ends of the first suture. Thus, when
the second suture is
pulled, this causes the two fixation member carriages to rotate in opposite
directions relative to
pulling the first suture.
[00110] FIGS. 12-13 show a tissue fixation device 210 having a housing 212,
and a helical
fixation member 214 which may be formed of a material such as Nitinol. FIG. 12
shows the helical
fixation member 214 in the deployed position, and FIG. 13 shows the helical
fixation member 214
in the retracted position. The helical fixation member 214 can be engaged with
a rotatable carriage
member 216. The helical fixation member can have a sharp beveled tip 218 that
is angled upward
toward the inserted tissue to help draw the fixation member 214 into the
tissue as the fixation
member is rotated into the deployed position.
[00111] In use, tissue may be received within housing 212, and the helical
fixation member 214
can be rotatably advanced into the tissue by rotating carriage member 216 to
engage and hold the
tissue relative to the housing 212. It will be appreciated that helical
fixation member 214 advances
along a deployment path which includes a rotational component and an axial
component relative to
the center housing axis.
[00112] FIGS. 14-15 show a tissue fixation device 310 having a housing 312,
and multiple
helical fixation members 314, 315 which may be formed of a material such as
Nitinol. FIG. 14
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shows the helical fixation members 314, 315 in the deployed position, and FIG.
15 shows the
helical fixation members 314, 315 in the retracted position. The helical
fixation members 314, 315
can be engaged with a rotatable carriage member 316. The helical fixation
members 314, 315 can
have sharp beveled tips 318 that are angled upward toward the inserted tissue
to help draw the
fixation members 314, 315 into the tissue as the fixation members 314, 315 are
rotated into the
deployed position. The sharp beveled tips 318 of each of the helical fixation
members 314, 315 can
be positioned out of phase with each other by 180 degrees.
[00113] In use, tissue may be received within housing 312, and the helical
fixation members 314,
315 can be rotatably advanced into the tissue by rotating carriage member 316
to engage and hold
the tissue relative to the housing 312. It will be appreciated that helical
fixation members 314, 315
advance along a deployment path which includes a rotational component and an
axial component
relative to the center housing axis. It will be appreciated that other
embodiments may include more
than two helical fixation members without departing from the spirit or scope
of the present
disclosure.
[00114] FIGS. 16-18 show a tissue fixation device 420 having a housing 422 and
at least one
curved fixation member 424. In this embodiment there are three curved fixation
members 424,
however, other embodiments may include more or fewer curved fixation members
424. FIGS. 16
and 17 show the curved fixation members 424 in the deployed position and FIG.
18 shows the
curved fixation members 424 in the retracted position. The curved fixation
members 424 may be
flexible, semi-flexible, or rigid. The curved fixation members 424 may be
advanced upward from
the housing 422, through tissue, and the tips 418 of the curved fixation
members 424 may then be
received in capture features 426 formed in the housing 422 to hold the tissue
relative to the housing
422. Other embodiments may reverse the deployment direction of the curved
fixation members 424.
For example, the curved fixation members 424 may be advanced downward from the
housing 422,
through tissue, such that the tips 418 of the curved fixation members 424 are
received in capture
features 426 formed in the lower portion of the housing 422. In this
embodiment, the position of the
apertures where the curved fixation members 424 exit the housing and the
capture features 426 are
reversed. In other embodiments, the curved fixation members 424 may be
advanced sideways from
the housing 422 and into capture features 426 formed on the sides of the
housing 422 such that the
apertures where the curved fixation members 424 exit the housing and the
capture features 426 lie
in a plane substantially perpendicular to the lengthwise central axis of the
housing 422.
[00115] FIGS. 19-20 show a tissue fixation device 510 having a housing 522 and
one or more
fixation members 524. In this example there are three fixation members,
however in other examples
there may be more or fewer fixation members 524. FIG. 19 shows the tissue
fixation device 510
with the fixation members 524 in the deployed position. FIG. 20 shows the
tissue fixation device
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510 with the fixation members 524 in the retracted configuration. The housing
can have angled
ramps 528 formed near the beveled tips 518 of the fixation members 524 which
force the fixation
members toward the center of the tissue fixation device 510 and into the
tissue as the fixation
members 524 are moved into the deployed position. The fixation members 524 can
be moved
between the deployed and retracted positions by means discussed herein
including sutures, levers,
sliding tabs, translating members or any other suitable mechanical means.
[00116] FIGS. 21-25 illustrate an alternative embodiment of a tissue fixation
device 610. The
tissue fixation device 610 includes a housing 612, a cap 615, and a fixation
member carriage
assembly 616 which carries at least one fixation member 614. In the example,
the fixation members
614 are needles formed from round stock and have pointed tips. In some
embodiments, the needles
may be hypodermic needles. The fixation member carriage assembly 616 is
captured between the
housing 612 and cap 615, and is rotatable within a track 626 formed in the
housing 612 and/or the
cap 615 to deploy and retract the fixation members, in the same manner as
described for device 10.
The housing may be referred to as a bell housing. The fixation members 614 are
movable between a
deployed configuration seen in FIGS. 21 and 22 and a retracted configuration
seen in FIGS. 23 and
24. The cap 615 attaches to the housing 612 via an interference fit which is a
snap fit. To provide
the interference fit, at least one flange 620 on the cap 615 engages with a
shoulder 622 and recess
624 on the housing 612. During assembly, the cap 615 is aligned with housing
612 with flange 620
adjacent shoulder 622. The cap is pushed against the housing so that flange
620 moves past
shoulder 622 and snaps into the recess 624 immediately below the shoulder 622.
Cap 615 includes
one or more bosses 654 with ramps 656 which deflect portions of the fixation
members out of the
track and housing when the carriage assembly 616 is rotated.
[00117] FIGS. 26-30 illustrate an alternative embodiment of a tissue fixation
device 710. The
tissue fixation device 710 includes a housing 712, a cap 715, and a fixation
member carriage
assembly 716 which carries at least one fixation member 714. In the example
shown, the fixation
members 714 are needles stamped from flat stock, and have pointed tips. The
fixation member
carriage assembly 716 is captured between the housing 712 and cap 715, and is
rotatable within a
track 726 formed in the housing 712 and/or the cap 715 to deploy and retract
the fixation members,
in the same manner as described for device 10. The housing may be referred to
as a bell housing.
The fixation members 714 are movable between a deployed configuration seen in
FIGS. 26 and 27
and a retracted configuration seen in FIGS. 28 and 30. The cap 715 attaches to
the housing 712 via
an interference fit which is a twisting fit. To provide the interference fit,
at least one flange 720 on
the cap 715 engages with shoulders 722 and recesses 724 on the housing 712.
The shoulders 722
may alternate with the recesses 724. During assembly, the cap 715 is aligned
with housing 712 with
flanges 720 fitting into recesses 724. The cap 715 is twisted so that upon
rotation, each flange 720
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moves out of its respective recess 724 and is captured under shoulder 722. If
the cap is twisted the
opposite direction, the flanges are released from under the shoulders and the
cap may be detached.
Cap 715 includes one or more bosses 754 with ramps 756 which deflect portions
of the fixation
members out of the track and housing when the carriage assembly 716 is
rotated.
[00118] A method of use may be the same for devices 610 and 710. In a method
of use of device
710, tissue is positioned in a central opening 708 of housing 712. Carriage
716 is rotated in a first
direction to deploy fixation members 714. One or more sutures 90, 94 or other
lines may be used to
rotate the carriage and deploy the needles, as described herein with regard to
device 10 and FIGS.
7A and 7B. Fixation members 714 deflect circumferentially inward of the
housing 712 and pierce
the tissue, capturing the tissue and fixing it relative to the device 710. At
this point, the device 710
may be moved to manipulate the tissue as desired. After desired tissue
movement has been carried
out, the carriage 716 is rotated in a second direction to retract the fixation
members 714. The
needles are pulled out of the tissue and back into the needle track 726, and
the tissue is released
from capture.
[00119] In some examples of use, the tissue is cervical tissue. The method of
use may further
include inserting a rod, tube or other elongated member (not shown) through
the opening in the
bottom of the housing, and into the cervix, with a portion of the elongated
member extending out of
the opening. After the needles are deployed, and the tissue is fixed relative
to the device 610 or 710,
the portion of the elongated member extending out of the opening may be
manipulated to move the
attached device and cervical tissue.
[00120] FIGS. 31A-36B illustrate another embodiment of a tissue fixation
device. Device 810
can include a housing 812, a cap 815, and a fixation member carriage assembly
816 which carries at
least one fixation member 814. In some examples, the fixation member 814 may
be a needle. The
fixation member carriage assembly 816 can be captured between the housing 812
and cap 815, and
may be rotatable within a track 826 formed in the housing 812 and/or the cap
815. It is appreciated
that many of the features and characteristics described for device 10 are
found on and also apply to
device 810.
[00121] The cap 815 and housing 812 may be referred to as a bell cap or a bell
housing,
respectively, as they may form a bell shape in some examples. The housing 812
includes at least
one enclosed section that completely encloses at least one planar surface. The
at least one planar
surface can be defined by a cross-sectional plane through the housing that
results in a planar surface
that is completely enclosed or surrounded by a portion of the housing. In
other words, the planar
surface is an empty plane that is completely bounded by the housing 812. For
example, with
reference to FIG. 31C, if a cross section of the housing 812 is taken
perpendicular to the
longitudinal central axis 35 and through the top portion of the housing, or
the cap 815, a circular
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planar surface would be created which lies within the opening, or inner space
33 of the housing 812
and which is completely bounded by or surrounded by the housing 812 or cap
815.
[00122] Referring to FIGS. 32 and 34, housing 812 is substantially
frustoconical and circular in
shape. However, the housing 812 can also be conical, cylindrical, funnel,
ovoid, or polygonal in
shape, or any combination of shapes thereof. The housing may include a base
822 which may be
circular, and a peripheral support wall 822 which terminates at a carriage
support 824. In the
example shown, the base 822 has the narrowest diameter of the housing, and the
housing slopes
outward to a widest diameter at the carriage support 824. Housing 812 may
include an opening 823
which may be shaped to engage with uterine manipulator (not shown). The
peripheral wall 834 and
base 822 may surround and define a housing inner space 833. The lengthwise
central axis 35 may
extend through the housing inner space 833, also defined by the peripheral
wall 834 and base 822.
[00123] The carriage support 824 can be ring-shaped, and include a carriage
track 826, which
may be substantially circular. An outer rim 828 circumscribes the outer
diameter of carriage track
826, and a step 830 may be formed intermediate the track 826 and the outer rim
828. One or more
apertures 832 can open through the carriage support 824, and may pass through
at least a portion of
the outer rim 828 and step 830. A housing inner wall 834 can circumscribe the
inner diameter of the
carriage track 826, and may include a plurality of discontinuations, or wall
gaps 836. At least one
edge 838 of each wall gap 836 may be beveled. When operatively assembled, the
fixation members
814 are deployable through the wall gaps 836; the beveled edges 838 may
promote smooth
deployment of the fixation members 814 and prevent the fixation members 814
from hanging up or
being caught in the wall gaps 836. Several slots 839 are formed in the housing
812 near the juncture
of the peripheral support wall 822 and carriage support 824. The slots 839
receive tabs 846 on the
cap 815 to lock the cap to the housing 812. Adjacent each slot 839 is a
housing lip 841 formed
along a portion of the peripheral wall 822.
[00124] Cap 815 may be annular, and may include an outer wall 50 generally
opposite an inner
wall 843. An outer surface 844 of the cap 815 may be positioned as an upper
surface, and may
include a plurality of steps, ridges and/or grooves which may facilitate
gripping and manipulating
the cap 815. The cap 815 may have circular outer and inner diameters, formed
by the outer wall 850
and inner wall 843 respectively. The cap inner wall 843 includes a plurality
of tabs 846 which
project inferiorly from the inner wall 843, alternating with a plurality of
gaps 847. Each tab 846
may include a cap lip 848 projecting from the tab. Tabs 846 and lips 848 may
be semicircular to
follow the outer shaped of the peripheral wall 822. The cap outer surface 844
may extend between
cap inner wall 43 and cap outer wall 50 and form a track cover 852. A
plurality of cap bosses 854
can project inwardly from the cap outer wall 850. Each cap boss 854 may
include a ramp feature
856 which urges one of the fixation members 814 inward as it is deployed. The
cap track cover 852
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includes one or more cap grooves 857, which may be semicircular, and which
guide the path of
fixation members 814 as they are deployed and retracted. Housing 812 and cap
815 may be formed
of plastic, or other materials listed herein.
[00125] Fixation carriage assembly 816 can include a substantially circular
fixation carriage 860.
Fixation member carriage 860 can have a first or superior side 874 and a
second or inferior side
876. A plurality of mounting features 862 can project superiorly from the
fixation carriage 860.
Each mounting feature 862 may include a recess 864 through which an opening
866 is formed.
Openings 866 can be sized to allow passage of a suture 90, but may also be
small enough to retain a
knotted suture, not permitting the knot to pass through the opening. A
circular setback or groove
878 can be formed on the inferior side 876 similar to groove 78 of device 10,
and be sized to
receive a suture.
[00126] Each fixation member 814 can be curved, rigid, and may terminate at a
beveled point.
The rigid fixation members may be formed of stainless steel, or other
materials disclosed herein.
Other embodiments may include flexible fixation members, which may be straight
or curved, and
may be made of Nitinol, for example. The fixation member curvature may be non-
concentric with
the curvature of the carriage track 826, for example the fixation member
curvature may have a
smaller diameter than the diameter of the carriage track (FIG. 36A). Each
fixation member 814 may
include a base portion 880, a shaft 882, and a point 884, which may also be
referred to as a tip. The
point 884 may be sharpened and/or serrated in order to reduce the forces
necessary to pierce the
tissue, or deploy the fixation member. Any of the fixation members disclosed
herein may also
include a sharp tip or point for the same purpose. The fixation member may
have an arch shape that
lies substantially in a single plane in some examples; in other examples, the
fixation member can be
substantially straight. In yet further examples, the fixation member can have
a curved shape in
multiple planes or in an infinite number of planes. When assembled into the
fixation member
carriage assembly 816, a mounting pin 872 may pass through the fixation member
base portion 880
and through carriage 860 to form a hinge type connection, about which the
fixation member 814
may pivot.
[00127] Cap 815 may be operatively assembled to housing 812 by insertion of
cap tabs 846 into
housing slots 839. When the tabs 846 are fully inserted into the slots 839,
each cap lip 848 may
snap over and positively engage a housing lip 841 to lock the cap 815 to the
housing 812. Fixation
member carriage 816 and the attached fixation members 814 may be captured
between the housing
and the cap. In the example shown in FIG. 34, cap tabs 846 are exterior to
housing peripheral wall
822. In another embodiment, the tabs 846 may be interior to the peripheral
wall. Attachment of the
cap 815 to the housing 812 encloses a fixation member retention space 888
bounded by fixation
member carriage 816, track cover 852, housing inner wall 834 and cap outer
wall 850. The
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mounting pins 872 project superiorly to the fixation carriage assembly 816 and
are captured in the
cap grooves 857.
[00128] A line passage or suture passage 886 may be formed between the groove
878 and outer
rim 828. Suture 90 may be threaded through one opening 866, along suture
passage 886 in the first
direction 100 and through one aperture 832. A knot 92 may be formed in the
suture end remaining
at opening 866, the knot residing in recess 864 immediately adjacent opening
866, and the knot
preventing withdrawal of the first suture through the opening 866. A free end
93 of suture 90
remains outside of the device 810. The second suture 94 may be threaded
through a second opening
866, along suture passage 886 in the second direction 102 opposite the first
direction, and through
another aperture 832. The second suture 94 may also be knotted, forming knot
96 to prevent
withdrawal. In another example, the first line 90 and/or second line 94 may be
secured in one or
more crimp tubes which reside in openings 866, the crimp tube(s) preventing
withdrawal of the first
and/or second suture through the corresponding opening 866. A free end 95 of
suture 94 remains
outside of the device 810. When the first and second sutures are thus placed,
pulling on the first
suture free end 93 will rotate the fixation member carriage assembly 816 in
the first direction 100,
and pulling on the second suture free end 95 will rotate the fixation member
carriage assembly 816
in the second, or opposite, direction 102.
[00129] With reference to Figures 36A and 36B, device 810 may be deployed in
the same
manner as device 10. The device may be place in the retracted configuration,
with the fixation
members 814 retracted into the fixation member retention space 888. Device 810
may be positioned
so that tissue, for example cervical tissue, is received in housing inner
space 833, with cap 815 and
housing peripheral wall 822 enclosing the tissue. The free end 93 of suture 90
may then be pulled,
rotating fixation member carriage assembly 816 in first direction 100. As the
fixation member
carriage assembly 816 rotates, the fixation member tips 884 will encounter the
ramps 856 on the
cap 815, and be deflected and forced inward through wall gaps 836 to protrude
into the housing
inner space 833, thus attaining the deployed configuration. Pins 872 translate
in grooves 857,
further guiding the fixation member deployment. The deployment paths of
fixation members 814
may be coplanar in some embodiments, and the fixation members 814 may be
deployed along a
plane perpendicular to the lengthwise central axis 35 of the housing 812. The
plane may also be
described as transverse to the lengthwise central axis 35. The plane may also
be coplanar with or
parallel to the planar surface which is completely enclosed by the housing.
The fixation members
814 may pierce and grip the tissue captured in the housing inner space 833. As
described for device
10, this can advantageously result in fixing the position of the tissue within
the housing 812, and
preventing the tissue from subsequently translating relative to the device 810
along the lengthwise
central axis. A stylus, tubular member, rod, or other elongated member (not
shown) may be inserted
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into device 810 through housing opening 823 and pass through the tissue, and
may pass out of
device 810 through cap 815, leaving a free end of the elongated member
exterior to the housing end
820. For example, an elongated tubular member may pass through housing opening
823 and into a
cervix captured in housing inner space 833. The elongated tubular member free
end may be
manipulated to move the device 810 and the tissue gripped within. Instruments,
bodily tissues, or
fluids may be passed through the elongated tubular member into or out of the
tissue. When desired,
free end 95 of suture 94 may be pulled to rotate the fixation member assembly
816 in the second
direction 102 and withdrawing the fixation members 814 from the tissue and
back into the retracted
configuration.
[00130] FIGS. 37 ¨ 60 disclose embodiments of fixation members, fixation
member carriages
and carriage assemblies which may be used in tissue fixation devices 10, 110,
210, 310, 410, 510,
610, 710, 810 or other tissue fixation devices. For example, a fixation member
carriage and the
fixation members carried thereon can be substituted for fixation member
assembly 816 in device
810, or substituted for fixation member assembly 16 in device 10. In each
example, the fixation
member(s) are deployable between a retracted configuration in which they are
retracted and the
tissue fixation device may be positioned relative to tissue to be captured,
and a deployed
configuration in which the fixation members are deployed to contact and
capture the tissue, and
subsequent movement of the device will move or manipulate the captured tissue.
The fixation
members may be needles. It is understood that each fixation member disclosed
herein may have a
sharp tip for piercing and/or engaging tissue such as cervical tissue. Each
fixation member disclosed
herein may be curved. The fixation members disclosed herein may be stamped,
formed from round
stock, formed from rod stock, or manufactured from materials and methods known
in the art for
making needles.
[00131] FIGS. 37A and 37B show a fixation member or needle 1314 mounted in a
carriage 1316.
A cap 1315 can capture needle 1314 in carriage 1316. Fixation member 1314
includes a convex
attachment feature 1320 shaped as a portion of a circle, which is received in
a concave capture
feature 1322 to form a ball joint. The ball joint allows polyaxial movement of
the fixation member
1314. Fixation member 1314 has a sharp tip 1326.
[00132] FIGS. 38A and 38B show a fixation member or needle 914 mounted in a
carriage 916.
An attachment feature 920 on the needle 914 is shaped as a cylinder. A pin 924
within a capture
feature 922 on carriage 916 receives the needle 914. When captured as shown,
needle 914 can rotate
about a single axis. Pin 924 may be molded into carriage 916. In other
embodiments, pin 924 and
other pins disclosed herein may be molded, press fit, glued, or welded.
[00133] FIG. 39 shows a needle 1014 mounted on a carriage 1016 in a capture
feature 1022. The
needle 1014 is pre-formed with bends 1030, 1032 and attachment feature 1020
folded into the
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needle. As carriage 1016 is rotated, attachment feature 1020 swings to allow
the needle to deploy
and retract. A cap (not shown) may hold needle 1014 in capture feature 1022.
[00134] FIGS. 40A-40C show a needle 1114, cap 1115 and carriage 1116. In FIG.
40C, the
needle 1114 is captured in between the cap 1115 and carriage 1116. The needle
1114 includes an
attachment feature 1120 wherein the needle end is bent approximately 90 to
allow capture in a
capture feature 1122. When captured, needle 1114 can rotate about at least one
axis. Needle 1114
may be formed from stainless steel round stock, and sharpened.
[00135] FIG. 41 shows a needle 1214 mounted on a carriage 1216 in a capture
feature 1222. The
needle 1214 is pre-formed with bends 1230, 1232 and attachment feature 1220
folded into the
needle. As carriage 1216 is rotated, attachment feature 1220 swings within
capture feature 1222 to
allow the needle to deploy and retract. A cap (not shown) may hold needle 1214
in capture feature
1222.
[00136] FIGS. 42A-42D show a metal carriage 1416 with pins 1424 press fit or
welded to the
carriage. One or more needles 1414 include an attachment feature 1420 which is
a hole shaped to
receive pin 1424. One end of pin 1424 may be deformed to retain the needle.
The metal carriage
1416 may be stamped or machined.
[00137] FIGS. 43A and 43B show a needle 1514 which may be created by stamping
out of flat
stock. The needle 1514 may then be bent or folded to create the V-shape seen
in the cross-section of
FIG. 20B. The needle 1520 may include one or more attachment features 1520,
which may be
shaped as pegs or posts, to attach to a carriage and/or cap as disclosed
elsewhere herein. The needle
1514 may be described as a stylet.
[00138] FIG. 44 shows a needle 1614 mounted on a carriage 1616. Carriage 1616
includes a
capture feature 1622 formed as a tab which extends over the carriage 1616 to
capture a pin 1624.
Needle 1614 includes an attachment feature shaped to receive the pin 1624 so
that when mounted,
the needle 1614 is captured on the pin 1624, between the carriage 1616 and the
capture feature
1622. In an embodiment formed from steel, capture feature 1622 may be
connected to the carriage
1616 at a hinge 1626. In an embodiment formed from plastic, capture feature
1624 may be folded
over and/or formed around a mold, and welded to carriage 1616. Needle 1614 may
be a stylet,
sharing the same features as needle 1514.
[00139] FIGS. 45A-45C show a carriage 1716 with capture features 1722 and a
needle 1714
having a hole 1720. A cap is not shown, but includes a number of retention
blocks 1725 equal to the
number of capture features 1722 on the carriage 1716. Each capture feature
1722 includes a pin
1724 and two holes 1726. Each retention block 1725 includes two pins 1734 and
one hole 1717,
plus a bore 1719. When assembled, needle 1714 is captured between carriage
1716 and cap 1715,
with pin 1724 extending from carriage 1716 through needle hole 1720 and bore
1719. Retention
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block pins 1724 extend into holes 1726. In another embodiment, the retention
block 1725 may be
part of the carriage 1716 instead of the cap 1715.
[00140] FIGS. 46A-46C show an embodiment including a stamped carriage 1816, a
needle 1814
and a pin 1824. Pin 1824 includes a head 1826 and a shoulder 1828. Needle 1814
includes an
attachment feature which is a hole 1820. Pin 1824 may be received in hole 1820
to mount needle
1814 to carriage 1816; head 1826 retains the needle 1814 on the pin 1824. The
carriage 1816
include capture features 1822 which may be holes to receive pins 1824.
[00141] FIGS. 47A-47C show an embodiment including a carriage 1916 and a
needle 1914, the
needle having an attachment features which is a pin 1924. A capture feature
1922 on the carriage
1916 includes a slot 1926 and a hole 1928. The needle can be snapped or rocked
into the capture
feature 1922, with pin 1924 moving through slot 1926 into hole 1928. The edges
1930, 1932 of the
slot 1926 may deform slightly as the pin 1924 is pushed in, then act as
interference to keep the pin
1924 in place in the capture feature.
[00142] FIGS. 48A-48D shows an embodiment similar to FIGS. 47A-47C. A needle
2014
includes a pin 2024 for attachment. Carriage 2016 includes a capture feature
2022 having a slot
2026. The pin 2024 is captured in the slot 2026 as shown. Not shown, a cap
2015 includes an inner
wall 2017 which holds the pin 2024 in the slot 2026.
[00143] FIGS. 49A and 49B show an embodiment similar to FIGS. 43A and 43B.
Needle 2114
includes an attachment feature 2120. A separate pin 2124 can attach the needle
to a carriage. Needle
2114 may be formed in the same way as described for needle 1514.
[00144] FIG. 50 shows another carriage and needle assembly stamped from a
single piece of
stock. The assembly includes carriage 2316 and needles 2314. The stock metal
may be stamped,
then the needles bent and sharpened. The needles 2314 project upward from
carriage 2316.
[00145] FIG. 51 shows another carriage and needle assembly stamped from a
single piece of
stock. The assembly includes carriage 2416 and needles 2414. The stock metal
may be stamped,
then the needles bent and sharpened. The needles 2414 project inward from
carriage 2416. A hinge
2420 is formed where each needle 2414 projects from carriage 2416; each hinge
2420 may be
formed by cutting away portions of the material between the needle and the
carriage. The hinge
2420 may be described as a living hinge. In FIGS. 50-51, the needles bend out
of the plane of the
carriage.
[00146] FIG. 52 shows an embodiment of a carriage assembly including a
carriage 2516 and
needles 2514. The carriage is formed from molded material such as polymer.
Pins 2524 attach the
needles to the carriage. In this embodiment, the pins 2524 and needles 2514
are in place when the
carriage 2516 is molded; the pins and needles are over-molded into the
carriage assembly.
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[00147] FIG. 53 shows an embodiment of a carriage assembly including a
carriage 2616 and a
needle 2614. When deployed, needle 2614 slides in a slot 2622 on carriage 2616
along axis 2601.
[00148] FIG. 54 shows another carriage and needle assembly including carriage
2816 and
needles 2814. The needles may be formed from flexible steel, and may be insert
molded into the
carriage. A hinge 2820 is formed where each needle 2814 projects from carriage
2816 at capture
feature 2822; each hinge 2820 may be formed by cutting away portions of the
needle. The hinge
2820 may be described as a living hinge, and may result in a springy needle.
Capture feature 2822
may be rigid.
[00149] FIG. 55 shows another carriage and needle assembly including carriage
2916 and needle
2914. Carriage 2916 include capture feature 2922 having a living hinge 2926.
Needle 2914 is
attached to the capture feature 2922 through overmolding; the needle is
overmolded directly into the
carriage.
[00150] FIG. 56 shows another carriage and needle assembly including carriage
3116 and at least
one needle 3114. A suture 90 is attached to the needle and can be manipulated
to activate the
needle. In this embodiment, the carriage 3116 does not move within a housing
such as housing
3012, but instead the needles 3114 are deployed by one or more sutures.
[00151] FIG. 57 shows another carriage and needle assembly including carriage
3216 and a
plurality of needles 3214. Carriage 3222 includes a plurality of capture
features 3222, and each
needle includes an attachment feature 3220 which may be received in a capture
feature. Unlike
other embodiments herein, needles 3214 are straight. When deployed, the
needles rotate
approximately 90 and project straight into a center opening 3208 of the
carriage 3216. When
retracted, the needles may point up.
[00152] FIG. 58 shows a tissue fixation carriage 3416 with a tissue fixation
member 3414
attached to the carriage by a plurality of attachment features 3420. Tissue
fixation member 3414 is
expandable and may include an expandable mesh which encircles a central
opening 3408. Small
teeth or barbs 3426 are formed on the edges of the fixation member 3414. When
carriage 3416 is
rotated in a first direction, fixation member 3414 expands and tissue may be
positioned in the
central opening 3408. When the carriage 3416 is rotated in a second direction,
fixation member
3414 contracts and the tissue is captured in the opening 3408. The barbs 3426
help prevent
withdrawal of the tissue.
[00153] FIGS. 59A and 59B are views of a tissue fixation device 3700 including
housing 3712,
cap 3715, and two needles 3714 captured in needle carriage 3716. Instead of
deploying
circumferentially inward, when deployed the needles drop down into the center
opening 3008 of the
device, capturing tissue positioned therein.
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[00154] FIG. 60 shows a tissue fixation device 3800 including housing 3812,
and several needles
3814 captured in needle carriage 3816. Each needle 3814 is compoundly curved,
having at least one
convex portion and one concave portion. When deployed, needles 3814 trap
tissue between the
needle 3814 and the carriage 3816.
[00155] It should be understood that the present apparatuses and methods are
not intended to be
limited to the particular forms disclosed. Rather, they are intended to
include all modifications,
equivalents, and alternatives falling within the scope of the claims. They are
further intended to
include embodiments which may be formed by combining features from the
disclosed
embodiments, and variants thereof.
[00156] The claims are not to be interpreted as including means-plus- or step-
plus-function
limitations, unless such a limitation is explicitly recited in a given claim
using the phrase(s) "means
for or "step for, respectively.
[00157] The term "coupled" is defined as connected, although not necessarily
directly, and not
necessarily mechanically.
[00158] The use of the word "a" or an when used in conjunction with the term
"comprising" in
the claims and/or the specification may mean one, but it is also consistent
with the meaning of
one or more or at least one. The term "about" means, in general, the stated
value plus or minus
5%. The use of the term or in the claims is used to mean "and/or" unless
explicitly indicated to
refer to alternatives only or the alternative are mutually exclusive, although
the disclosure supports
a definition that refers to only alternatives and "and/or."
[00159] The terms "comprise" (and any form of comprise, such as "comprises"
and
"comprising"), have (and any form of have, such as has and "having"),
"include" (and any form
of include, such as "includes" and "including") and "contain" (and any form of
contain, such as
"contains" and "containing") are open-ended linking verbs. As a result, a
method or device that
"comprises," has, "includes" or "contains" one or more steps or elements,
possesses those one or
more steps or elements, but is not limited to possessing only those one or
more elements. Likewise,
a step of a method or an element of a device that "comprises," has, "includes"
or "contains" one or
more features, possesses those one or more features, but is not limited to
possessing only those one
or more features. Furthermore, a device or structure that is configured in a
certain way is configured
in at least that way, but may also be configured in ways that are not listed.
[00160] The present invention may be embodied in other specific forms without
departing from
its spirit or essential characteristics. It is appreciated that various
features of the above-described
examples can be mixed and matched to form a variety of other alternatives. For
example, fixation
members, needles, hooks or barbs may be interchangeable in any of the
embodiments set forth
herein, as may the actuation means for deployment. As such, the described
embodiments are to be
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considered in all respects only as illustrative and not restrictive.
Similarly, manufacturing,
assembly methods, and materials described for one device may be used in the
manufacture or
assembly of another device. The scope of the invention is, therefore,
indicated by the appended
claims rather than by the foregoing description. All changes which come within
the meaning and
range of equivalency of the claims are to be embraced within their scope.
