U.S. patent number RE47,209 [Application Number 15/499,611] was granted by the patent office on 2019-01-22 for suture securement devices.
This patent grant is currently assigned to Edwards Lifesciences Corporation. The grantee listed for this patent is Edwards Lifesciences Corporation. Invention is credited to Hengchu Cao, Mohammad Jafari, Manouchehr A. Miraki, Ralph Schneider, Ming H. Wu.
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United States Patent |
RE47,209 |
Jafari , et al. |
January 22, 2019 |
Suture securement devices
Abstract
Disclosed herein are exemplary embodiments of suture securement
devices that replace the need to tie knots in sutures. Some
embodiments comprise an annular outer body and one or more suture
engagement tabs extending inwardly from the outer body. The devices
can comprise a superelastic and/or shape-memory material and have a
generally in-plane initial configuration. The suture engagement
portions are deformable out-of-plane to an active configuration
with the outer body compressed and the tabs interlocked with each
other. The device can be heat-set in the deformed configuration.
The interlocked tabs exert a pinching force on sutures passing
between them that restricts the sutures from sliding through the
opening in one longitudinal direction.
Inventors: |
Jafari; Mohammad (Foothill
Ranch, CA), Wu; Ming H. (Tustin, CA), Cao; Hengchu
(Irvine, CA), Schneider; Ralph (Trabuco Canyon, CA),
Miraki; Manouchehr A. (Laguna Hills, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Edwards Lifesciences Corporation |
Irvine |
CA |
US |
|
|
Assignee: |
Edwards Lifesciences
Corporation (Irvine, CA)
|
Family
ID: |
49916535 |
Appl.
No.: |
15/499,611 |
Filed: |
April 27, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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61720886 |
Oct 31, 2012 |
|
|
|
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61670001 |
Jul 10, 2012 |
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|
Reissue of: |
13938071 |
Jul 9, 2013 |
9498202 |
Nov 22, 2016 |
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/0401 (20130101); A61B 17/0487 (20130101); A61B
17/0401 (20130101); Y10T 24/155 (20150115); A61B
2017/0461 (20130101); A61F 2/2448 (20130101); A61B
2017/0464 (20130101); A61B 2017/0404 (20130101); A61B
17/0642 (20130101); A61B 2017/0438 (20130101); A61B
2017/0448 (20130101); A61F 2/0811 (20130101); A61B
2017/0454 (20130101); A61B 2017/042 (20130101); Y10T
24/44923 (20150115); B65D 33/1625 (20130101); A61B
2017/0456 (20130101); A61B 2017/0446 (20130101); A61B
2017/0437 (20130101); A61B 2017/049 (20130101); A61B
2017/0458 (20130101); A61B 17/0487 (20130101); A61B
2017/0419 (20130101); A61B 2017/0462 (20130101); A61B
2017/0451 (20130101); A61B 2017/0406 (20130101); A61B
2017/0488 (20130101); A61B 2017/045 (20130101) |
Current International
Class: |
A61B
17/04 (20060101); A61B 17/064 (20060101) |
Field of
Search: |
;606/232 |
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Primary Examiner: Flanagan; Beverly M
Attorney, Agent or Firm: Klarquist Sparkman LLC
Parent Case Text
RELATED APPLICATIONS
This application .Iadd.is a Reissue Application of U.S. Pat. No.
9,498,202, issued Nov. 22, 2016, which .Iaddend.claims priority
under 35 U.S.C. .sctn.119 to U.S. Provisional Application No.
61/720,886, filed Oct. 31, 2012, and to U.S. Provisional
Application No. 61/670,001, filed Jul. 10, 2012.
Claims
We claim:
1. A device for securing one or more sutures, comprising: a
generally disk-shaped body having an annular outer body that
defines an annular outer edge, a first tab extending radially
inwardly from a first side of the annular outer body and a second
tab extending radially inwardly from a second side of the annular
outer body; first and second curved slots passing through the
disk-shaped body within the annular outer body, wherein the first
and second curved slots define sides of the first and second tabs;
and a middle slit connecting the curved slots and separating the
first and second tabs, the slit and curved slots generally forming
a closed H-shaped opening through the body within the annular outer
body, the slit being sized to receive and hold one or more sutures,
and opposed edges of the first and second tabs positioned across
the slit from each other form suture engagement portions; wherein
each of the first and second tabs has a base end that connects to
the annular outer body and a free end that borders the slit, the
base ends having a width that extends between an end of the first
curved slot and an opposing end of the second curved slot, and the
widths of the base ends of the first and second tabs are shorter
than widths of the free ends of the first and second tabs, such
that the first and second tabs are encouraged to articulate
relative to the annular outer body along the width of their base
ends; wherein the device comprises an elastically resilient
material and has a flat natural configuration when no sutures are
positioned in the slit; wherein the device has an active
configuration wherein the first and second tabs are elastically
deformed out of a plane defined by the annular outer body when one
or more sutures are positioned through the slit in a direction
generally perpendicular to the plane defined the annular outer
body; wherein the elastically deformable first and second tabs
allow the device to change from the natural configuration to the
active configuration to receive and secure one or more sutures
between the suture engagement portions; and wherein, in the active
configuration, the suture engagement portions exert a pinching
force on the one or more sutures that restricts the sutures from
sliding through the slit in at least one longitudinal direction of
the sutures.
2. The device of claim 1, wherein the device has a substantially
uniform thickness in the natural configuration.
3. The device of claim 1, wherein the slit has a straight suture
receiving portion and first and second angled end portions on
opposite ends of the suture receiving portion configured to block
received sutures from sliding laterally along the slit from the
suture receiving portion of the slit into the curved slots, wherein
the first angled end portion of the slit is adjacent to the first
curved slot and the second angled end portion of the slit is
adjacent to the second curved slot.
4. The device of claim 1, wherein the slit has a straight suture
receiving portion and first and second serpentine end portions on
opposite sides of the suture receiving portion configured to block
received sutures from sliding laterally along the slit from the
suture receiving portion into the curved slots, wherein the first
serpentine end portion of the slit is adjacent to the first curved
slot and the second serpentine end portion of the slit is adjacent
to the second curved slot.
5. The device of claim 1, wherein the curved slots terminate in
enlarged circular portions located where the first and second tabs
join with the annular outer body, such that the enlarged circular
portions reduce stress concentrations when the tabs elastically
deform out of the plane defined by the annular outer body.
6. The device of claim 1, wherein the tabs are equal in size.
7. The device of claim 1, wherein the tabs are dissimilar, with one
being larger than the other.
8. The device of claim 1, wherein elastic deformation of the first
and second tabs occurs at locations where the first and second tabs
join with the annular outer body.
9. The device of claim 1, wherein the curved slots have curved
radially inner surfaces, the curved radially inner surfaces being
curved lateral surfaces of the first and second tabs.
10. The device of claim 1, wherein each of the curved slots has a
constant width along a majority of the length of the respective
curved slot.
11. The device of claim 1, wherein the annular outer body comprises
two opposing radial cutouts in the outer edge of the device.
12. The device of claim 1, wherein the slit extends a distance
between the first and second tabs that is at least 50% of an outer
diameter of the device.
13. The device of claim 1, wherein each of the first and second
tabs has a length dimension that extends from the slit to the
annular outer body in a direction perpendicular to the slit,
wherein the annular outer body has a radial dimension that extends
from the curved slot radially outwardly to the annular outer edge,
and wherein the length dimension of the first and second tabs is
greater than or equal to the radial dimension of the annular outer
body.
14. The device of claim 1, further comprising a suture extending
through the device between the first and second tabs, wherein the
first and second tabs are bent relative to the annular outer body
at junctions where the first and second tabs are connected to the
annular outer body.
15. A method of using the device of claim 1, comprising inserting a
suture through the device between the first and second tabs, the
insertion of the suture occurring while the first and second tabs
are bent relative to the annular outer body at junctions where the
first and second tabs are connected to the annular outer body.
16. A device for securing one or more sutures, comprising: a
generally disk-shaped body having an annular outer body that
defines an annular outer edge; a first tab extending radially
inwardly from a first side of the annular outer body and a second
tab extending radially inwardly from a second side of the annular
outer body; first and second slots passing through the disk-shaped
body within the annular outer body, wherein the first and second
slots define lateral sides of the first and second tabs; and a
middle slit connecting the first and second slots and separating
the first and second tabs, the slit and two slots forming a closed
opening through the body within the annular outer body, the slit
being configured to receive and hold at least one suture such that
opposed edges of the first and second tabs positioned across the
slit from each other form suture engagement portions; wherein the
slit comprises a straight suture receiving portion having a first
end closer to the first slot and a second end closer to the second
slot, and the slit further comprises first and second non-straight
portions on opposite ends of the straight suture receiving portion
with the first non-straight portion extending from the first end of
the straight suture receiving portion toward the first slot and the
second non-straight portion extending from the second end of the
straight suture receiving portion toward the second slot, the
non-straight portions of the slit being configured to block a
received suture from sliding laterally along the slit from the
suture receiving portion into either of the slots; wherein the
device comprises an elastically resilient material and has a
natural configuration when no suture is positioned in the slit;
wherein the device has an active configuration wherein the first
and second tabs are elastically deformed when at least one suture
is positioned through the slit; and wherein, in the active
configuration, the suture engagement portions exert a pinching
force on at least one suture extending through the slit that
restricts the at least one suture from sliding through the slit in
at least one longitudinal direction of the suture.
17. The device of claim 16, wherein: the slit extends in a first
major direction of the device that is perpendicular to the
longitudinal direction of a suture passing through the slit, and
the first and second tabs extend toward each other in a second
major direction of the device that is perpendicular to the first
major direction and perpendicular to the longitudinal direction of
a suture passing through the slit; and the first and second
non-straight portions of the of the slit extend back and forth in
the second major direction as the slit extends radially outwardly
in the first major direction.
18. The device of claim 17, wherein the first and second
non-straight portions of the of the slit comprise serpentine
sections of the slit that curve back and forth in the second major
direction as the slit extends radially outwardly in the first major
direction.
19. The device of claim 16, wherein the slit extends a distance
across the device that is at least 50% of an outer diameter of the
device.
20. The device of claim 16, wherein the first and second slots have
a constant radial width along a majority of the length of the
respective slot.
21. The device of claim 16, wherein the largest diameter of the
device is less than 5 mm.
22. A device for securing one or more sutures, comprising: a
generally disk-shaped body having a thickness and a radial
dimension perpendicular to the thickness, the body having an
annular outer body that defines an annular outer radial edge; a
first tab extending radially inwardly from a first side of the
annular outer body and a second tab extending radially inwardly
from a second side of the annular outer body; first and second
slots passing through the thickness of the disk-shaped body and
positioned radially within the annular outer body, wherein the
first and second slots define lateral sides of the first and second
tabs; and a middle slit extending through the thickness of the body
and radially connecting the first and second slots and separating
the first and second tabs, the slit and two slots forming a closed
opening passing through the thickness of the body and positioned
radially within the annular outer body, the slit being configured
to receive and hold at least one suture such that opposed surfaces
of the first and second tabs positioned across the slit from each
other form suture engagement portions, and wherein the slit has a
constant spacing width between the first and second tabs across the
thickness of the body; wherein the device comprises an elastically
resilient material and has a natural configuration when no suture
is positioned in the slit; wherein the device has an active
configuration wherein the first and second tabs are elastically
deformed when at least one suture is positioned through the slit;
and wherein, in the active configuration, the suture engagement
portions exert a pinching force on at least one suture extending
through the slit that restricts the at least one suture from
sliding through the slit in at least one longitudinal direction of
the suture.
23. The device of claim 22, wherein the slit comprises a straight
suture receiving portion having a first end closer to the first
slot and a second end closer to the second slot, and the slit
further comprises first and second non-straight portions on
opposite ends of the straight suture receiving portion with the
first non-straight portion extending from the first end of the
straight suture receiving portion toward the first slot and the
second non-straight portion extending from the second end of the
straight suture receiving portion toward the second slot, the
non-straight portions of the slit being configured to restrict a
received suture from sliding radially along the slit from the
suture receiving portion into either of the slots.
.Iadd.24. A device for securing one or more sutures, comprising: a
disk-shaped body comprising a resiliently deformable material, the
disk-shaped body comprising an annular outer body that defines an
outer edge of the device, a first tab extending inwardly from the
annular outer body, and a second tab extending inwardly from the
annular outer body; first and second slots passing through the
device between the annular outer body and the first and second
tabs, wherein the first and second slots define lateral sides of
the first and second tabs; and a suture-receiving slit connecting
the first and second slots and separating the first and second
tabs, the slit and slots together forming an opening through the
device within the annular outer body, wherein opposed surfaces of
the first and second tabs positioned across the slit from each
other form suture engagement portions of the tabs; wherein each of
the first and second tabs has a base end that connects to the
annular outer body and a free end that borders the slit, each of
the base ends of the first and second tabs having a base end width
that extends between an end of the first slot and an end of the
second slot, each of the free ends of the first and second tabs
having a free end width equal to a length of the slit, and the base
end widths are shorter than the free end widths such that the first
and second tabs are encouraged to articulate relative to the
annular outer body along their base ends; wherein the device has a
natural configuration when no sutures are positioned in the slit,
and the device has an active configuration wherein the first and
second tabs are resiliently deformed relative to the annular outer
body with one or more sutures are positioned through the slit;
wherein the resiliently deformable first and second tabs allow the
device to change from the natural configuration to the active
configuration to receive and secure one or more sutures between the
suture engagement portions; and wherein, in the active
configuration, the suture engagement portions exert a pinching
force on the one or more sutures that restricts the sutures from
sliding through the slit in at least one longitudinal direction of
the sutures. .Iaddend.
.Iadd.25. The device of claim 24, wherein the first and second
slots terminate in enlarged rounded portions located where the base
ends of the first and second tabs join with the annular outer body,
such that the enlarged rounded portions reduce stress
concentrations when the tabs deform relative to the annular outer
body. .Iaddend.
.Iadd.26. The device of claim 24, wherein the first and second
slots have non-linear radially inner surfaces, the non-linear
radially inner surfaces forming lateral surfaces of the first and
second tabs. .Iaddend.
.Iadd.27. The device of claim 24, wherein each of the first and
second slots has a substantially constant width along a majority of
the length of the respective slot. .Iaddend.
.Iadd.28. The device of claim 24, wherein the annular outer body
comprises two opposing radial cutouts in the outer edge of the
device. .Iaddend.
.Iadd.29. The device of claim 24, wherein the slit extends a
distance between the first and second slots that is at least 50% of
a maximum outer diameter of the device. .Iaddend.
.Iadd.30. The device of claim 24, wherein each of the first and
second tabs has a length dimension that extends in a direction
perpendicular to the slit from the slit to an imaginary line
extending between ends of the first and second slots, wherein the
annular outer body has a radial dimension that extends from the
slots radially outwardly to the outer edge of the device, and
wherein the length dimension of the first and second tabs is
greater than or equal to the radial dimension of the annular outer
body. .Iaddend.
.Iadd.31. The device of claim 24, further comprising a suture
extending through the device between the free ends of the first and
second tabs, and wherein the first and second tabs are deformed
relative to the annular outer body at their base ends where the
first and second tabs are connected to the annular outer body.
.Iaddend.
.Iadd.32. Inserting a suture through the device of claim 24 between
the free ends of the first and second tabs, the insertion of the
suture occurring while the first and second tabs are deformed
relative to the annular outer body at the base ends of the first
and tabs. .Iaddend.
Description
FIELD
This disclosure relates to devices for securing sutures.
BACKGROUND
Prosthetic devices are often implanted using sutures. For example,
prosthetic heart valves and annuloplasty rings can be secured to a
native valve annulus using sutures. Conventionally, the loose ends
of the sutures are tied in knots to secure them together and/or to
secure the prosthetic device to the adjacent tissue. However, the
process of tying knots in sutures can be time consuming and
difficult, the amount of slack left in the sutures can be difficult
to control, the knots can be difficult or impossible to untie,
and/or the knots can accidentally come loose. Thus, there is a need
in the art for ways to secure sutures without tying knots.
SUMMARY
Disclosed herein are exemplary embodiments of suture securement
devices that replace the need to tie knots in sutures. Some
embodiments of a suture securement device comprise an outer body,
an opening passing through the outer body for receiving one or more
sutures, and at least one suture engagement portion extending from
the outer body to the opening. The device comprises a resiliently
deformable material and has a natural configuration when no sutures
are positioned in the opening. The opening has a width that is
smaller than a diameter of the suture when the device is in the
natural configuration. The at least one suture engagement portion
is resiliently deformable to an active configuration when a suture
is positioned through the opening. In the active configuration, the
at least one suture engagement portion exerts a pinching force on
the suture that restricts the suture from sliding through the
opening in at least one longitudinal direction of the suture.
In some of these embodiments, the device comprises two, three,
four, or more suture engagement portions extending inwardly from
the outer body that are resiliently deformable to an active
configuration when one or more sutures are positioned through the
opening.
In some embodiments, the outer body comprises a fully annular body
that encloses the opening, while in other embodiments, the outer
body comprises a radial slit or opening that communicates with the
opening to allow a suture to be slid laterally through the slit
into the opening. In some of the embodiments with a slit, the
device further comprises an open region between a portion of the
outer body and the suture engagement portions, and the open region
communicates with the opening and the slit.
In some embodiments, at least one of the suture engagement portions
projects out-of-plane from the outer body in the natural
configuration, such that the device is biased to allow a suture
positioned in the opening to slide through the opening with
relatively little resistance in one longitudinal direction while
preventing the suture from sliding through the opening in the other
longitudinal direction.
Some exemplary devices for securing one or more sutures comprising
a first end portion, a second end portion, and an intermediate
third portion coupling the first end portion to the second end
portion. Each of the first, second and third portions comprise an
at least partially annular body having an internal passageway
extending therethrough in a longitudinal direction of the device.
The first, second and third portions are resiliently deformable
relative to one another in a plane generally perpendicular to the
longitudinal direction. The device has a natural configuration,
free of elastic deformation, wherein at least one of the first,
second and third portions is twisted relative to the other portions
such that the internal passageways are misaligned with one another;
and the device has a deformed configuration wherein at least one of
the first, second and third portions is resiliently deformed
relative the other portions such that the internal passageways of
the first, second and third portions are substantially aligned in
the longitudinal direction. One or more sutures can be positioned
through the aligned internal passageways when the device is in the
deformed configuration and the device is configured to pinch the
one or more sutures between the first, second and third portions
when the device is allowed to return toward its natural
configuration.
Some embodiments comprise a first spine segment flexibly coupling
the first end portion to the third portion and a second spine
segment flexibly coupling the second end portion to the third
portion. Each of the first, second and third portions can comprise
a partially annular body having an open section, wherein the open
sections of the first, second and third portions are misaligned in
the natural configuration and are aligned in the deformed
configuration to allow one or more sutures to be laterally inserted
into the internal passageways. The first and second end portions
can be aligned with each other in the longitudinal direction in
both the natural and deformed configurations.
In some implementations, a tool can be used with the device to hold
the device in the deformed configuration and then release the
device to return toward the natural configuration. The tool can
comprise a handle and first and second jaws that are configured to
apply a compression force on the device to hold it in the deformed
position while one or more sutures are inserted laterally through
the aligned open sections.
Some embodiments of suture securement devices described herein can
have a curved body that has a generally uniform thickness and/or
generally parallel convex and concave major surfaces. In some
embodiments, the curved devices can be cut from a sidewall of a
tube, such as tube having a circular cross-sectional profile and a
uniform wall thickness. The curved devices can be biased such that
suture(s) can be readily inserted through the device from the
concave side and are prevented from sliding back out through the
concave side.
An exemplary method of forming a suture clip can comprise first
forming a flat or curved suture clip having an annular outer body
and an a two opposing tabs extending toward each other within the
outer body, with the tabs being in-plane with the outer body. For
instance, curved slots on either side of the tabs and a middle slit
between the tabs connect to each other but do not intersect with an
outer edge of the body, thus forming a "closed" generally H-shaped
opening extending from one face of the device to the other. The
method can further comprise bending the suture clip to a deformed
configuration with the outer body compressed in an in-plane
direction and the tabs extending out-of-plane from the outer body.
The method can further comprise heat-setting the suture clip in the
deformed configuration. The clip can comprise a superelastic and/or
shape-memory material such as Nitinol. In some embodiments, the two
tabs interlock with each other in the deformed configuration. In
some embodiments, the outer body is compressed in the direction
that the tabs extend from the outer body. In some embodiments,
bending the suture clip comprises compressing the outer body from a
generally elliptical shape to a generally circular shape, or from a
generally circular shape to a generally elliptical shape.
Some exemplary suture clips comprising an upper panel and a lower
panel coupled together along a fold line at one end. The upper
panel can comprise a slit and a biased tab configured to allow a
suture engaged in the slit to slide more freely in one axial
direction and less freely in an opposite axial direction, and the
lower panel can comprise a slot configured to constrain a sutured
engaged in the slit from migrating along the length of the
slit.
The foregoing and other objects, features, and advantages of the
invention will become more apparent from the following detailed
description, which proceeds with reference to the accompanying
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a top view of an exemplary annuloplasty ring implanted at
the mitral annulus using knotted sutures.
FIG. 2 is a top view of an exemplary annuloplasty ring implanted at
the mitral annulus using exemplary suture clips to secure the
sutures.
FIG. 3 is a perspective view of an exemplary suture clip.
FIG. 4 is a perspective view of another exemplary suture clip.
FIG. 5A is a plan view of another exemplary suture clip.
FIG. 5B is a perspective view of the suture clip of FIG. 5A.
FIG. 6A is a plan view of another exemplary suture clip.
FIG. 6B is a perspective view of the suture clip of FIG. 6A.
FIG. 7A is a plan view of another exemplary suture clip.
FIG. 7B is a perspective view of the suture clip of FIG. 7A.
FIG. 8 is a perspective view of another exemplary suture clip.
FIG. 9A is a perspective view of another exemplary suture clip.
FIG. 9B is another perspective view of the suture clip of FIG.
9A.
FIG. 10A is a plan view of another exemplary suture clip.
FIG. 10B is a perspective view of the suture clip of FIG. 10A.
FIG. 11A is a perspective view of another exemplary suture
clip.
FIG. 11B is another perspective view of the suture clip of FIG.
11A, showing the clip engaged with two sutures.
FIG. 11C is a perspective view of another exemplary suture
clip.
FIG. 11D is a perspective view of another exemplary suture clip
having serpentine sections of a central slit to help retain sutures
therein.
FIG. 12A is a perspective view of another exemplary suture
clip.
FIG. 12B is a sectional perspective view of the suture clip of FIG.
12A engaged with a suture.
FIG. 12C is a plan view of the suture clip of FIG. 12A.
FIG. 12D is a side view of the suture clip of FIG. 12A.
FIG. 13 is a plan view of another exemplary suture clip.
FIG. 14 is a perspective view of an exemplary suture securement
device.
FIG. 15 is another perspective view of the suture securement device
of FIG. 14.
FIG. 16 is an end view of the suture securement device of FIG.
14.
FIG. 17 is a perspective view of the suture securement device of
FIG. 14 in a resiliently deformed state.
FIG. 18 shows the suture securement device of FIG. 14 being held
within an exemplary deployment device.
FIG. 19 shows the suture securement device of FIG. 14 released from
the deployment device of FIG. 18.
FIG. 20 shows the suture securement device of FIG. 14 positioned
around two free suture ends using the deployment device of FIG. 18
to implant a prosthetic device.
FIG. 21 shows the suture securement device of FIG. 14 freed from
the deployment device of FIG. 18 and secured around two suture
ends.
FIG. 22 is a perspective view of another exemplary suture
securement device.
FIG. 23 is another perspective view of the suture securement device
of FIG. 22.
FIG. 24 is an end view of the suture securement device of FIG.
22.
FIG. 25 is a perspective view of the device of FIG. 22 in a
deformed configuration.
FIGS. 26-31 are perspective views of exemplary curved suture
clips.
FIGS. 32-35 are various views of another exemplary suture clip.
FIGS. 36-38 are various views of yet another exemplary suture
clip.
FIGS. 39-42 are various views of still another exemplary suture
clip.
FIGS. 43-45 show different way in which sutures can be used with
the clip of FIG. 31.
FIGS. 46 and 47 are views of another exemplary suture clip.
DETAILED DESCRIPTION
Rather than tying knots to secure sutures, suture clips or other
suture securement devices can be placed on sutures to secure them.
Several exemplary embodiments of suture securement devices are
disclosed herein and shown in the attached figures. These
embodiments should not be construed as limiting in any way.
Instead, the present disclosure is directed toward all novel and
nonobvious features and aspects of the various disclosed
embodiments, alone and in various combinations and sub-combinations
with one another.
The disclosed devices can secure a single suture or to two or more
sutures at the same time. For ease of description, this disclosure
generally describes the various embodiments in use with only a
single suture, though it should be understood that the disclosed
embodiments may be used with two or more sutures in the same or
similar manner, unless otherwise described.
The disclosed devices can be positioned on a suture by threading a
free end of the suture through an opening in the device and/or by
sliding the suture laterally through a slit in the side of the
device, depending on the particular embodiment. For example, the
embodiment shown in FIGS. 3 and 4 require that an end of a suture
be threaded through an enclosed opening in the device, whereas the
embodiments of FIGS. 5-10 also have a slit in a lateral side that
allows an intermediate portion of a suture to be laterally inserted
into the device.
Once a suture securement device is positioned on a suture, the
device can prevent the suture from sliding axially through the
device in one or both longitudinal directions of the suture. In
some embodiments, the device can be biased to allow the suture to
slide through the device in one longitudinal direction, but prevent
the suture from sliding in the opposite direction, forming a
one-way suture lock, or ratchet mechanism. In other embodiments,
the device can prevent the suture from sliding in both longitudinal
directions, forming a more restrictive two-way suture lock.
FIG. 1 shows an exemplary prosthetic device in the form of an
annuloplasty ring 2 secured to the annulus of a native mitral valve
4 using sutures 6. Ends of the sutures 6 are secured together using
conventional knots 8. FIG. 2 shows the same annuloplasty ring 2
secured to the mitral annulus using exemplary suture securement
devices 10 instead of knots. Twelve devices 10 are used in this
example, though different numbers of devices can be used in other
implementations. In this example, each device 10 secures together
two sutures 6 extending from opposite directions, in place of a
standard knot. In other examples, a separate device 10 can be
secured to each suture 6 at the location where the suture passes
through the annuloplasty ring 2. Either way, the devices 10 prevent
the sutures 6 from sliding through the devices toward the
annuloplasty ring 2, keeping the sutures taught and keeping the
ring 2 secured against the mitral valve tissue 4. In some
embodiments, such as the devices 10 shown in FIG. 2, the devices
also allow the sutures 6 to be further tightened after an initial
deployment to reduce any excess slack in the sutures. Though the
exemplary suture securement devices 10 are shown in the example of
FIG. 2, any of the embodiments disclosed herein can be used for the
same or similar purposes on other implementations.
While FIG. 2 shows an annuloplasty ring being secured by devices
10, the devices 10, as well as the other embodiments of suture
securement devices disclosed herein, can be used to secure other
prosthetic devices to tissue in the body. Other prosthetic devices
include, for example, prosthetic heart valves, stems, grafts, and
various other prosthetic implants conventionally secured to tissue
using sutures.
By using the disclosed suture securement devices rather than tying
knots in the sutures, the sutures can be secured in less time and
with less difficulty (especially in hard-to-reach locations). In
addition, some suture securement devices can allow the amount of
slack left in the sutures to be more precisely controlled, the
devices can be less likely to come loose than knots, and some
embodiments of the devices can be easily removed or adjusted after
they are initially deployed. Furthermore, the suture securement
devices can be small, durable, biocompatible, and inexpensive.
FIG. 3 shows an exemplary embodiment of an enclosed, biased suture
securement device 12. The device 12 comprises an annular outer body
14 and four triangular tabs 16 that extend out-of-plane from the
outer body 14. The tabs 16 are separated by four radial slits 18
extending from a central opening 20. Because there are no lateral
slits in the outer body 14 (i.e., the device 12 is "enclosed"), an
end of a suture is threaded through the opening 20 to engage the
device 12 with the suture. Due to the biased shape of the tabs 16,
the suture can be readily threaded through the opening 20 from the
bottom of the device 12. The opening 20 can have a diameter, or
narrowest width, that is slightly smaller than the diameter of the
suture such that the tabs 16 are forced to deflect upward and
outward a small amount when the suture is inserted from the bottom
of the device. In a static state with a suture positioned in the
opening 20, the tabs 16 can be slightly elastically deformed and
thereby biased against the suture to prevent the suture from
sliding. As used herein, the terms "elastic," "elastically," and
"elasticity" are used in a broad sense to indicate any resilient
deformation that tends to naturally return to its pre-deformed
state, and these terms include the related concepts of
superelasticity and pseudoelasticity. When tension is applied on an
upper end of the suture, the tabs 16 deflect slightly further in
the upward and radially outward directions, increasing the size of
the opening 20 enough to allow the suture to slide through the
opening 20 in the upward direction. However, when tension is
applied on the lower end of the suture, the suture pulls the tabs
16 downward causing the tabs to pinch closer together, increasing
their grip on the suture, and preventing the suture from sliding
downward. Biased devices, such as the device 12, can be positioned
with the bottom surface of the outer body 14 against a bearing
surface (e.g., a surface of prosthetic device or a surface of
native tissue) to prevent the suture and the device from moving in
the direction of that bearing surface.
FIG. 4 shows an exemplary embodiment of an enclosed, non-biased
suture securement device 22. The device 22 comprises an annular
outer body 23 and three inwardly extending tabs 24 separated by
three curved slits 26 that join at a common center opening 28. The
device 22 is termed "non-biased" because the tabs 24 do not project
out of plane in either axial direction when a suture is not
positioned in the opening 28. Thus, non-biased devices are not
inherently biased in one direction or the other, though they may
become biased in one direction once a suture in inserted. Like in
the device 12, the opening 28 can have a diameter, or narrowest
width, that is slightly smaller than the diameter of a suture. As
the device 22 is non-biased in its natural state, the suture can be
threaded through the opening 28 from either the top or the bottom
equivalently. Because the opening 28 in its natural state is
narrower than the suture, when the suture is inserted the tabs 24
are forced to deflect out of plane a small amount in the direction
the suture is inserted to increase the size of the opening 28
enough to allow the suture to pass through. When a suture is
inserted into the opening 28 from one side, the tabs 24 bend toward
the other side, creating an out-of-plane aspect to the tabs 24 and
making the device biased. For example, when a suture is inserted
from the bottom side of the opening 28, the tabs 24 bend upwardly
to increase the size of the opening 28 enough to receive the
suture. At that point, the tabs 24 are biased to allow the suture
to slide upwardly with limited resistance but prevent the suture
from sliding downwardly. The curved shaped of the slits 26 can
provide a more desirable stress-strain distribution across the tabs
24 for certain materials, such as Nitinol, compared to the linear,
radial slits 18 in the device 12, which can be more desirable for
other materials, such as stainless steel.
FIGS. 5A and 5B show an exemplary embodiment of an open, biased
suture securement device 30. The device 30 comprises an outer body
32 and a first tab 34, second tab 36, third tab 38 and a spring arm
42, each of which extends inwardly and out-of-plane from the outer
body 32 toward a central opening 48. The device 30 is "open"
because the central opening 48 communicates with a radial slit 46
that allows an intermediate portion of a suture to be laterally
slid into the opening 48 instead of an end of the suture being
threaded through the opening from the top or the bottom. The spring
arm 42 comprises a spring element 44 that allows the arm 42 to
elastically deform radially outwardly toward the outer body 30.
When a suture is slid through the slit 46 toward the opening 48,
the spring arm 42 can elastically deform to widen the slit 46 and
allow the suture to enter the opening 48. In some embodiments, a
tool can be used to deform the spring arm 42 during deployment,
though the tapered walls of the slit 46 can allow the spring arm 42
to be sufficiently deformed with relatively little radially-inward
force on the suture. A greater force on the suture is required to
deform the spring arm 42 once the suture is in the opening, due to
the shorter lever arm and the lack of the tapered walls for
mechanical advantage. In its natural state, the opening 48 is
slightly smaller than the diameter of the suture such that radial
pressure is applied on the suture in the opening 48 even when there
is no tension on the suture. Due to the out-of-plane dimensions of
the tabs 34, 36, 38 and spring arm 42, the suture is allowed to
slide upwardly through the opening 48 with little resistance, but
is prevented from sliding downwardly through the opening as the
tabs collapse and pinch the suture.
FIGS. 6-8 show exemplary embodiments of open, non-biased suture
securement devices. FIGS. 6A and 6B show a device 50 that comprises
an outer body 32, a first arm 54, and a second arm 56. The first
and second arm a separated by a slit 58 that extends inwardly from
the outer perimeter of the device to an open region 60. The width
of the slit 58 between the arms 56 and 54 can be slightly smaller
than the diameter of a suture. The slit 58 can be tapered near the
outer perimeter to facilitate inserting a suture into the narrow
portion of the slit between the arms. The open region 60 can make
the outer body more flexible to allow the arms 54, 56 to be
separated to receive a suture. The device 50 can also comprise
openings 62 on either side of the slit 58 to facilitate using a
tool (e.g., a tool similar to needle-nose pliers) to forcibly
separate the arms 54, 56. When two or more sutures are secured with
the device 50, the sutures are desirably oriented side-by-side
along the length of the slit 58, rather than being stacked in the
width direction of the slit. In some embodiments, the device 50
does not deform out-of-plane when the suture is inserted, but
rather only deforms in-plane and applies an in-plane pinching force
on the suture that prevents the suture from sliding in either axial
direction. In other embodiments, both arms 54, 56 can deform out of
plane in the same direction, creating a biased device that prevents
the suture from sliding in only on axial direction. In still other
embodiments, the arms 54, 56 can deform out-of-plane in opposite
directions, with the outer body 52 twisting, such that the suture
is prevented from sliding in both directions.
FIGS. 7A and 7B show another open, non-biased device 64 that is
similar to the device 50. The device 64 comprises an outer body 66,
a first arm 68, and a second arm 70. The first and second arm a
separated by a slit 72, which extends inwardly from the outer
perimeter of the device to another slit portion 74 that extends at
right angles from the slit 72 to an open region 76. The width of
the slit 72 between the arms 68, 70 can be slightly smaller than
the diameter of a suture. The slit 72 can be tapered near the outer
perimeter to facilitate inserting a suture into the narrow portion
of the slit between the arms. The open region 76 can make the outer
body more flexible to allow the arms 68, 70 to be separated to
receive a suture. In use, one or more sutures are held within the
slit 72 by the pinching force of the arms 68, 70. Because the slits
72 and 74 are at right angles, the sutures are less likely to slide
out of the slit and into the open region 76, as compared to the
device 50. Also, the width of the slit 74 can be made smaller that
the slit 72, and in some cases the slit 74 is closed with the arms
74 and 70 touching each other. The device 64 can also comprise
openings 78 on either side of the slit 72 to facilitate using a
tool to forcibly separate the arms. In some embodiments, the device
64 does not deform out-of-plane when the suture is inserted, but
rather only deforms in-plane and applies an in-plane pinching force
on the suture that prevents the suture from sliding in either axial
direction. In other embodiments, both arms 68, 70 can deform out of
plane in the same direction, creating a biased device that prevents
the suture from sliding in only on axial direction. In still other
embodiments, the arms 68, 70 can deform out-of-plane in opposite
directions, with the outer body 66 twisting, such that the suture
is prevented from sliding in both directions. FIG. 8 shows a device
80 that is similar to the device 64, except that it further
comprises a notch 82 in each arm 84, 86 adjacent to the slit 72.
The notches 82 help hold the two sutures in the slit 72 in a
desirable position, and help prevent the sutures from sliding out
of the slit.
FIGS. 9A and 9B show an open, biased device 100 that is similar to
the device 64, except that it includes an out-of-plane dimension.
The device 100 comprises an outer body 102, a first arm 104, and a
second arm 106. The first and second arm a separated by a slit 108
that extends inwardly from the outer perimeter of the device to
another slit portion 110, which extends at right angles from the
slit 108 to an open region 112. The width of the slit 108 between
the arms 104, 106 can be slightly smaller than the diameter of a
suture. The slit 108 can be tapered near the outer perimeter to
facilitate inserting a suture into the narrow portion of the slit
between the arms. The open region 112 can make the outer body more
flexible to allow the arms 104, 106 to be separated to receive a
suture. The device 100 can also comprise openings 114 on either
side of the slit 108 to facilitate using a tool to forcibly
separate the arms. The arms 104 and 106 can extend upwardly,
out-of-plane from the outer body 102 to create a bias that allows
the suture to slide upwardly with little resistance but prevents
the suture from sliding downwardly.
FIGS. 10A and 10B show another open, non-biased device 116. The
device 116 comprises an outer body 118, a first arm 120 and a
second arm 122. The first and second arms are separated by a curved
slit 124 that extends inwardly from the outer perimeter of the
device to another slit portion 126, which extends at right angles
from the slit 124 to an open region 128. The narrowest width of the
slit 124 can be slightly smaller than the diameter of a suture to
retain the suture within the slit 124. The slit 124 can be tapered
from the outer perimeter to facilitate inserting a suture into the
narrowest portion of the slit 124. The open region 128 can
circumscribe an arc of about 270.degree. through the device 116,
making the outer body 118 more flexible to allow the arms 120, 122
to be separated to receive a suture. The arm 120 can be partially
curled around the end of the arm 122 and can comprise an end
portion 121 that blocks the arm 122 from being separated too far
from the first arm 120, thereby limiting the width of the slit
124.
FIGS. 11A and 11B show embodiments of a closed, non-biased suture
fastening device 130. The device 130 comprises a generally
disk-shaped body having an annular outer edge 132 and two tabs 134,
136 that extend inwardly from the outer edge 132. Each tab 134, 136
is shaped generally in a half-circle. The tabs 134, 136 are
separated from the outer body at their sides by curved slots 138,
140 and are separated from each other by a straight slit 142
generally bifurcating the device 130. The curved slots 138, 140 and
middle slit 142 connect to each other but do not intersect with an
outer edge 132, thus forming a "closed" generally H-shaped opening
extending from one face of the device to the other. One or more
sutures 143 can be inserted into the slit 142 from either the top
or the bottom, deflecting both tabs 134, 136 in the direction of
insertion, as shown in FIG. 11B. Once the sutures 143 are inserted
as shown in FIG. 11B, the device 130 becomes biased and allows the
sutures to move axially upward with little resistance but prevents
the sutures from moving axially downward. In some embodiments, the
gripping edges of the tabs 134, 136 can be sharp (see FIG. 11A),
which can provide better grip on the sutures, and in other
embodiments the gripping edges of the tabs can be rounded (see FIG.
11B), which can reduce the likelihood of damaging and/or cutting
the sutures. In some implementations of the device 130 (not shown),
the two tabs 134, 136 can be elastically deformed in opposite
directions with one tab bending upwardly out-of-plane and the other
tab bending downwardly out-of-plane. This can lock the sutures from
sliding in either direction through the device 130. The two sutures
143 shown in FIG. 11B can correspond to free ends of the sutures 6
shown in FIG. 2, for example.
FIG. 11C shows a device 144 that is a variation of the device 130
wherein the gripping surfaces of the tabs 134, 136 comprise notched
or recess regions 145 that can help contain the sutures within the
slit 142 and prevent them from sliding into the curved slits 138,
140.
FIG. 11D shows a still further variation of the suture fastening
device 146 having a flat generally disk-shaped body having an
annular outer edge 132' and two tabs 134', 136' that extend
inwardly therefrom. As in FIG. 11A, each tab 134', 136' is shaped
generally in a half-circle. The tabs 134', 136' are separated from
the outer body at their sides by curved slots 138', 140' and are
separated from each other by a slit 142' that has a straight
midsection. Once again, the curved slots 138', 140' and middle slit
142' connect to each other but do not intersect with an outer edge
of the body 132', thus forming a "closed" generally H-shaped
opening extending from one face of the device to the other. One or
more sutures can be inserted into the slit 142 from either the top
or the bottom, deflecting both tabs 134, 136 in the direction of
insertion, as was shown in FIG. 11B. Once the sutures 143 are
inserted in the slit 142, the device 146 becomes biased and allows
the sutures to move axially upward with little resistance but
prevents the sutures from moving axially downward. As mentioned
above, the gripping edges of the tabs 134, 136 may be sharp for
better grip on the sutures, or rounded to reduce the likelihood of
damaging and/or cutting the sutures.
To help retain sutures in the midsection of the slit 142', the slit
includes serpentine sections 147 on either side. The tabs 134',
136' are identical, or mirror images of each other, though one may
be larger than the other. Small circular enlargements 148 on the
terminal end of each curved slot 138', 140' facilitate bending of
the tabs 134', 136' and act as stress relievers to reduce the
chance of fracture at those points. Two semi-circular cutouts 149
are provided on opposite sides of the outer edge 132' perpendicular
to the straight section of the slit 142'. The cutouts 148 provide
orientation features for the suture fastening device 146 that
cooperate with features on a tool (not shown) which can hold and
deploy multiple devices in series.
FIGS. 12A-12D show an embodiment of a closed, biased device 150.
The device 150 comprises an annular outer body 152, and two
engagement tabs 154, 156 and two side tabs 158, 160 extending
inwardly from the outer body 152. The tabs 154, 156 and/or the tabs
158, 160 can also extend upwardly out-of-plane from the outer body
152. The engagement tabs 154, 156 can comprise concave engagement
surfaces 162 to keep the suture 164 centered between them. The side
tabs 158, 160 can prevent the suture 164 from sliding laterally out
from between the engagement arms 154, 156. The engagement arms 154,
156 are biased to allow the suture 164 to slide upwardly through
the device 150 with little resistance but prevent the suture from
sliding downwardly through the device.
FIG. 13 shows an embodiment of a closed, non-biased device 166
comprising a generally oblong or oval shaped outer body 168 and a
single tab 170. The tab 170 is separated from the outer body on
three sides via a cut 172 that forms a general "C" shape. For
example, the cut 172 can be laser cut into a single sheet of
material to form the tab 170. The tab 170 can be elastically bent
either direction out-of-plane from the outer body 168 to allow a
suture to be inserted through the cut 172. After a suture in
introduced through the cut 172, the device 166 becomes biased to
allow the suture to slide in the direction the tab 170 is bent with
little resistance but prevent the suture from sliding in the
opposite direction.
The devices of FIGS. 3-13 can vary in thickness, though the
thickness is generally smaller than the dimensions perpendicular to
the thickness. Increased thickness generally results in a more
rigid device that provides more resistance to the suture sliding
through the device. The devices of FIGS. 3-13 can also vary in the
dimensions perpendicular to the thickness dimension. In some
embodiments, the device can have an outer diameter of about 2 mm to
about 5 mm, or larger.
The disclosed suture securement devices can comprise any
resiliently deformable, corrosion-resistant, biocompatible
material, such as stainless steel, cobalt-chrome (Co--Cr), Elgiloy,
MP35N, and Nitinol. Some embodiments can comprise more than one
material, such as a more rigid material for the outer body and a
more elastically flexible material for the arms/tabs. Desirably,
the disclosed embodiments are comprised of material with a
recoverable strain that is sufficient to retain sutures, such as a
recoverable strain that ranges from about 5% to about 15%.
FIGS. 14-17 show an exemplary suture securement device 200. The
device 200 comprises three or more sections that are coupled
together along an elastic spine. The device 200 can comprise a
first section 202, second section 204, and third section 206, with
the first and second sections coupled by a first spine segment 208
and the second and third sections coupled together by a second
spine segment 210. In other embodiments, the device can comprise
four or more similar sections coupled by three or more spine
segments. As shown in FIG. 15, each section can comprise an annular
wall (e.g., cylindrical or otherwise) that is open at one side
opposite the spine. The section 202 comprises an opening 216, the
section 204 comprises an opening 218, and the section 206 comprises
an opening 220. In its natural state, as shown in FIGS. 14-16, the
device 200 is configured with at least one section being misaligned
from one or both of the other sections (see FIG. 16). The spine
segments 208 and 210 are twisted such that the second section 204
is misaligned with the first and thirst sections 202, 204, which
can be generally aligned with each other.
The device 200 can be elastically deformed to align all of the
sections in a cylindrical configuration such that the openings 216,
218, 220 are also aligned, as shown in FIG. 17. As shown in FIGS.
18 and 19, a tool 222 can be used to hold the device 200 in the
configuration shown in FIG. 17. The tool 222 can comprise a handle
224, a first jaw 226 and a second jaw 228. The jaws 226, 228 can
have rounded inner walls 230, 232, respectively, to hold the device
200 in the configuration of FIG. 17. In this elastically deformed,
aligned configuration, one or more sutures can be inserted into the
device 200 through the aligned openings 215, 218, 220, as shown in
FIG. 20. As shown in FIG. 21, once the sutures are positioned
inside the device 200, the jaws 226, 228 can be opened, releasing
their compressive force on the device 200, and allowing the device
to elastically spring back toward its natural shape. In the example
of FIGS. 20 and 21, the device 200 is used to secure two sutures 6
together to secure an annuloplasty ring 2 to a native mitral
annulus 4. The sutures 6 can block the device 200 from returning
completely to its natural shape, leaving a portion of the elastic
deformation in the device such that the device is biased against
the sutures. In the configuration of FIG. 21, the first and third
sections 202, 206 exert a force toward the right on the suture 6,
while the second section 204 exerts a force toward the left on the
sutures, effectively pinching the sutures together with enough
force to create sufficient frictional resistance to the sutures
sliding longitudinally out of the device. Having three or more
segments in the device 200 provides a more balanced force
distribution on the sutures and enhances the device's grip in the
sutures 6. The edges of each section 202, 204, 206 can also bite
into the sutures 6 to some degree to enhance the device's grip on
the sutures.
FIGS. 22-25 show another embodiment of a suture securement device
240 that functions in a manner similar to the device 200. The
device 240 comprises three (or more) sections 242, 244, 246 coupled
together by flexible spine segments 248, 250. Each section 242,
244, 246 comprises an annular wall that is open at one side
opposite the spine. Compared to the segments 202, 204, 206 of the
similar device 200, the segments 242, 244, 246 of the device 240
have a thicker annular wall and a narrower open region within the
annular wall. This allows the device 240 to engage onto a suture
with less twisting motion compared to the device 200. The first
section 242 has an opening 252 in the annular wall and an inner
suture engagement surface 258, the second section 244 has an
opening 254 in the annular wall and an inner suture engagement
surface 260, and the third section 246 has an opening 256 in the
annular wall and an inner suture engagement surface 262.
In its natural state (not shown), the sections 242, 244, 246 of the
device 240 are misaligned, like the device 200 in FIGS. 14-17. In
the misaligned natural configuration, the end sections 242 and 246
are twisted about the spine 248, 250 in the direction of the
surfaces 258 and 262 are facing, and the middle section 244 is
twisted about the spine in the opposite direction. When the device
240 is elastically deformed to the position shown in FIG. 25 (such
as with a tool similar to the tool 222), the openings 252, 254, 256
of the three sections are aligned, allowing a suture to be inserted
laterally through the openings and into an axial passageway
extending through the three sections 242, 242, 246.
With the suture positioned through the axial passageway, the device
240 can be released from compression and allowed to elastically
return toward the natural position. Before reaching the natural
position, the engagement surfaces 258, 260, 262 contact the suture
and exert opposing lateral forces on the suture to hold the suture
in the device 240 and prevent the suture from sliding
longitudinally out of the device in either direction. Because the
annular bodies of the sections 242, 244, 246 are thicker than those
in the device 200, the engagement surfaces 258, 260, 262 contact
the suture with less recoil motion compared to the device 200. This
can allow for a stronger clamping force and more durability.
Some suture securement devices can have a generally curved shape.
The embodiments shown in FIGS. 26-31 are examples of devices having
a curved shape. In these embodiments, the device can have an upper
major surface that is generally convex and a lower major surface
that is generally concave. The upper and lower major surfaces can
be substantially parallel to each other, with the devices having a
substantially constant thickness between the two major surfaces. In
some embodiments, the upper and lower major surfaces can be curved
in one direction and non-curved in a perpendicular direction (like
a sidewall of a cylinder), such that the surfaces have central axis
of curvature. In some embodiments, both major surfaces can have a
common central axis of curvature. In other embodiments, the major
surfaces can be curved in other manners, such as having concentric
spherical major surfaces that share a common center of curvature.
By providing suture securement devices with a curved structure, the
devices can be biased to provide greater resistance to sutures
moving toward the concave direction while more readily allowing
sutures to move toward the convex direction.
In some embodiments, such curved devices can be formed from a
sidewall of a tube. The outer radius of the tube can define the
curvature of the convex major surface of the device while the inner
radius of the tube can define the curvature of the concave major
surface of the device. The uniform thickness of a curved device can
be equal to the wall thickness of the tube that the device is cut
from. In other embodiments, the devices can be formed from a
sidewall of a non-cylindrical tube, or from a wall of other
three-dimensional objects having a curved wall, such as a hollow
sphere, spheroid, ellipsoid, etc., or from other three-dimensional
objects having a curvature.
FIG. 26 shows an exemplary embodiment of a curved suture securement
device 300. The device 300 comprises an annular outer body 302 and
an inner body, or tab, 304 that is separated from the outer body by
a "C" shaped slit 306. The convex, upper major surface of the
device 300 is shown in FIG. 26. The tab 304 can have an elliptical
shape and can extend from a connection to the outer body in the
direction of the curvature of the device. One or more sutures can
be inserted through the slit 306 from the concave, lower side of
the device 300, causing the tab 304 to deflect upwardly. With
sutures inserted through the slit 306, the biased tab 304 pinches
the sutures and prevents them from sliding back through the slit
toward the concave direction. Thus, the device 300 can be attached
to sutures with the concave side of the device facing a prosthetic
device or tissue from which the free ends of the sutures
extend.
FIG. 27 shows an alternative embodiment of a curved suture
securement device 310 that is similar to the device 300 but has
greater curvature. The device 310 comprises an annular outer body
312, an inner tab 314, and a "C" shaped slit 316. The increased
curvature of the device 310 relative to the device 300 can result
in increased bias and increased resistance to sutures sliding
through the slit 316 toward the concave direction. The embodiments
300 and 310 represent two examples of different curvatures, while
other embodiments can have any other degree of curvature desired.
Similarly, the thickness of the curved devices can vary and can be
selected to provide a desired stiffness for the device.
FIG. 28 shows an embodiment of a curved suture securement device
320 that comprises an annular outer body 322 and two opposing tabs
324, 326, similar to a flat version shown in FIGS. 11A-11C. The
outer body 322 can have a generally circular shape and each of the
tabs 324, 326 can have a generally half-circle shape. The tabs 324,
326 are separated from the outer body by two arcuate slots 328 and
the tabs are separated from each other by a straight slit 329 that
connects the two arcuate slots 328. One or more sutures can be
inserted into the slit 329 from the lower convex side, deflecting
both tabs 324, 326 upwardly in the direction of insertion. With the
sutures inserted, the biased tabs allow the sutures to move
upwardly in the convex direction with little resistance but prevent
the sutures from moving downwardly in the concave direction.
FIG. 29 shows another embodiment of a curved suture securement
device 330 that comprises an annular outer body 332 and two
opposing tabs 334, 336. The outer body 332 can have a generally
circular shape and each of the tabs 334, 326 can extend inwardly
from opposite ends of the outer body. The tabs 334, 336 are
separated from the outer body by two arcuate slots 338 and the tabs
are separated from each other by a slit 339 that connects the two
arcuate slots 338. The slit 339 can have a straight middle portion
for placement of sutures and angled or L-shaped end portions 331 at
either end of the straight portion that can help retain the sutures
in the straight portion of the slit 339 and prevent the sutures
from migrating into the arcuate slots 338. The two tabs 334, 336
are thus dissimilar, with the larger left tab 334 extending around
the right tab 336 on both sides at the L-shaped end portions 331 of
the slit 339. One or more sutures can be inserted into the slit 339
from the lower convex side, deflecting both tabs 334, 336 upwardly
in the direction of insertion. With the sutures inserted, the
biased tabs allow the sutures to move upwardly in the convex
direction with little resistance but prevent the sutures from
moving downwardly in the concave direction.
FIG. 30 shows an embodiment of a curved suture securement device
340 that comprises an annular outer body 342, a coiled or spiraled
inner body 344 extending within the outer body, and a coiled or
spiraled slit 346. Sutures can be inserted through the coiled slit
346 at any point along the slit, such as at the central end of the
slit, from the concave side of the device, causing the coiled inner
body to deform toward the convex side and causing a biased clamping
force on the sutures that prevents the sutures from sliding back
toward the concave direction.
FIG. 31 shows an embodiment of a curved suture securement device
350 that comprises an annular outer body 352 and two inner tabs
354, 356 are defined within the outer body by two arcuate slits
358, 360, respectively. The tabs 354, 356 extend in opposite
directions from a central portion of the device between the slits
358, 360. Each of the slits 358, 360 can receive one or more
sutures from the concave lower side of the device, causing the
respective tabs 354, 356 to deform upwardly and causing a biased
clamping force on the sutures that prevents the sutures from
sliding back toward the downward, concave direction.
In some embodiments, the device 350 can further comprise an opening
362 in one end of the outer body 352 adjacent the slit 358 and an
opening 364 in an opposite end of the outer body 352 adjacent the
slit 360. The openings 362 and 364 can be used to secure (e.g.,
suture) the device 350 to another surface, such as a surface of a
prosthetic device or underlying tissue. Any of the suture clip
embodiments disclosed herein can comprise additional openings,
similar to the openings 362 and 364, for securing the clip to an
underlying surface.
Any of the curved embodiments described herein can have a thickness
of, for example, from about 0.001 inches to about 0.100 inches,
such as about 0.010 inches. Any of the curved embodiments described
herein can have a radius of curvature of the convex major surface
of, for example, greater than about 2.0 mm, such as about 4.0 mm.
Any of the curved embodiments described herein can comprise
superelastic and/or shape memory material, such as Nitinol.
FIGS. 32-42 illustrate embodiments of suture clips that are
initially formed in an in-plane configuration (e.g., a flat,
in-plane configuration or a curved in-plane configuration) and are
then are deformed and heat-set in an out-of-plane, functional
configuration. As used with reference to FIGS. 32-42, the term
"in-plane configuration" refers to the position of the tabs being
generally in-plane with the outer body, and includes configurations
such as those shown in FIGS. 26-31 having a curved or arched
overall shape.
The clip embodiment 400 shown in FIGS. 32-35 comprises an annular
outer body 402 and two opposing tabs 404, 406 that are separated
from the outer body by slots 408. The clip 400 is initially formed
in a flat, planar configuration with the two tabs 404, 406 being
in-plane with the outer body 402. The clip 400 can be cut from a
flat sheet of material, for example. The initial flat, in-plane
clip can have a circular shape. The flat, circular clip 400 can
then be deformed to the configuration shown in FIGS. 32-35 by
applying compression at the edges adjacent to the ends labeled 420
in the directions of arrows 421 while pushing the tabs 404, 406
upward out-of-plane from the outer body. The compression at the
ends 420 causes the annular body 402 to become elliptical and
causes the tabs 404, 406 to move toward each other and interlock in
the out-of-plane formation, with the arms 410 of the tab 404
engaged with the shoulders 416 of the tab 406 and the end portion
414 of the tab 406 engaged with the intermediate portion 412 of the
tab 404.
The clip 400 can be comprised of a superelastic and/or shape memory
material, such as Nitinol, such that the clip 400 can be heat-set
in the deformed configuration shown in FIGS. 32-35. In order to
hold the clip 400 in the deformed configuration shown in FIGS.
32-35 during a heat-setting process, the upper surface of the
annular body 402 can be held against a flat, planar surface (as
illustrated by the dashed line in FIG. 35) while the tabs 404, 406
are bent into the interlocked configuration through an opening, in
the flat, planar surface. For example, a flat plate with a hole in
it can be used as the flat, planar surface. While the clip 400 is
held against such a plate with the tabs extending through the hole
in the interlocked configuration, the temperature of the clip
material can be increased to a sufficient level for a sufficient
time to allow the Nitinol to become heat-set in the configuration
illustrated. The heat-setting process can comprise, for example,
placing the deformed clip in a furnace to heat the clip above a
given temperature for a given period of time, and then immersing
the heated clip into a cooler body of water to quench the clip
below a certain temperature and complete the heat-setting
process.
The deflection of the tabs 404, 406 twists the annular body 402 at
each of the end portions 420, causing those end portions 420 to
deflect downward, as shown in FIGS. 34 and 35. With the tabs 404,
406 interlocked, one or more sutures of any diameter can be
inserted through the interface 418 between the two tabs to bend the
tabs further upward and create a biased locking mechanism that
resists movement of the sutures in the downward direction. The arms
410 can also block the sutures from sliding laterally out of the
interface 418.
FIGS. 36-38 illustrate a suture clip embodiment 430 that is similar
to the embodiment 400. The clip 430 comprises an annular outer body
432 and two tabs 434, 436 that interlock in an out-of-plane
configuration to create a biased suture engagement similar to the
tabs 404, 406 of the clip 400. The clip 430 can be initially formed
in a curved, in-plane, circular configuration, like the embodiment
330 shown in FIG. 29. The annular body 432 can be held against a
concave surface (as illustrated by the dashed line in FIG. 38),
such as a curved plate, with the end portions 450 compressed
together in the direction of arrows 451 and the tabs 434, 436
deflected upward, such as through a hole in the plate, and in the
interlocking position shown in FIG. 37. The clip 430 can be
heat-set in this configuration, as described above, such that the
annular body 432 is arched with downwardly deflected end portions
450, the arms 440 of the tab 434 are engaged on the shoulder
portions 446 of the tab 436, and the end portion 444 of the tab 436
engaged with the intermediate portion 442 of the tab 434. With the
tabs 434, 436 interlocked, one or more sutures of any diameter can
be inserted through the interface 448 to bend the tabs further
upward and create a biased locking mechanism that resists movement
of the sutures in the downward direction. The arms 440 can also
block the sutures from sliding laterally out of the interface
448.
FIGS. 39-42 illustrate another embodiment of a suture clip 460 that
is initially formed with an elongated, elliptical annular outer
body 462 instead of a circular outer body, as with the clips 400
and 430. By initially forming the clip 460 in an elongated,
elliptical shape, as shown in FIG. 39, the clip 460 can be deformed
into a generally circular shape, as shown in FIG. 40, by
compressing diametrically opposing edges 480 in the direction of
arrows 482. The embodiments 400, 430 and 460 illustrate that a
suture clip can be designed to result in any desirable shape after
a heat-setting process by selecting a corresponding initial
configuration. In other embodiments, the annular outer body can
have a polygonal shape or other non-elliptical, non-circular shape.
In the embodiment 460, the tabs 464, 466 are slightly longer than
the tabs 434, 436 of the clip 430, but otherwise function in a
similar manner such that they have an interlocked configuration
after the heat-setting process with the arms 470 engaged with the
shoulders 476 and the end portion 474 engaged with the intermediate
portion 472. With the tabs 464, 466 interlocked, one or more
sutures of any diameter can be inserted through the interface 478
to bend the tabs further upward and create a biased locking
mechanism that resists movement of the sutures in the downward
direction. The arms 470 can also block the sutures from sliding
laterally out of the interface 478.
In the embodiments 400, 430 and 460, the opposing tabs may not
interlock together in a deformed, out-of-plane configuration unless
the annular outer body is compressed together to allow the opposing
tabs to move closer together. Without the compression of the outer
body, a gap is formed between the ends of the two tabs when they
are bent out-of-plane from the outer body and gaps are formed
between the arms of the one tab and the shoulders of the other tab.
These gaps may not allow the two tabs to properly interlock in the
deformed position. Thus, by compressing the annular body together,
and heat-setting the clip in the compressed state, the tabs are
provided with the ability to engage each other in the interlocked
configuration. The touching interface between the end portions of
the tabs allows the tabs to exert a clamping force on any diameter
of sutures, even very small diameter sutures.
FIGS. 43-44 show various configurations in which the clip 350 of
FIG. 31 can be engaged with sutures. As shown in FIG. 43, the clip
350 can be used to secure two different sutures. The suture 370 is
engaged in the slit 358 and the suture 372 is engaged in the
opposite slit 360. Due to the curvature of the clip 350 and the
upward deflection of the tabs 354, 356, the sutures 370, 372 are
allowed to move upwardly through the slits 358, 360, but are
prevented from sliding downwardly through the slits. As shown in
FIG. 44, the clip 350 can also be used to secure two different
portions of the same suture 374 that both pass upwardly through
opposite slits. The two free ends of the suture 374 can be pulled
upwardly to tighten the lower looped portion of the suture toward
the bottom of the clip, but the tabs 354, 356 prevent the suture
from sliding downward and loosening. FIG. 45 shows another
variation where a single suture 376 passes through both slits 358,
360. In FIG. 45, the suture 376 has free ends that extend in
opposite lateral directions from the slits, rather that extending
upwardly as in FIG. 44.
FIGS. 46 and 47 show an embodiment of a suture clip 500 that
comprises two folded panels 502 and 504. The upper panel 502 is
similar to the clip 340 in FIG. 30, in that it comprises a spiral
slit 506 that defines a spiral tab 508. The lower panel 504
comprises a slot 510 extending from one end to the center of the
lower panel. The upper and lower panels 502 and 504 can be coupled
together along a fold at one end opposite the slot 510. One or more
sutures 512, 514 can be threaded through the spiral slit 506 in the
upper panel and through the slot 510 in the lower panel to secure
the sutures. The upper panel 502 can be curved, like the clip 340
in FIG. 30, such that the spiral tab 508 is biased to allow the
sutures to slide upwardly through the slit 506 but prevents the
sutures from sliding downwardly toward the lower panel 504. The
slot 510 can help prevent the sutures 512, 514 from migrating
around the spiral slit 506, keeping the sutures near the center of
the spiral.
General Considerations
For purposes of this description, certain aspects, advantages, and
novel features of the embodiments of this disclosure are described
herein. The disclosed methods, apparatuses, and systems should not
be construed as limiting in any way. Instead, the present
disclosure is directed toward all novel and nonobvious features and
aspects of the various disclosed embodiments, alone and in various
combinations and sub-combinations with one another. The methods,
apparatuses, and systems are not limited to any specific aspect or
feature or combination thereof, nor do the disclosed embodiments
require that any one or more specific advantages be present or
problems be solved.
As used herein, the terms "a", "an" and "at least one" encompass
one or more of the specified element. That is, if two of a
particular element are present, one of these elements is also
present and thus "an" element is present. The terms "a plurality
of" and "plural" mean two or more of the specified element.
As used herein, the term "and/or" used between the last two of a
list of elements means any one or more of the listed elements. For
example, the phrase "A, B, and/or C" means "A," "B," "C," "A and
B," "A and C," "B and C" or "A, B and C."
As used herein, the term "coupled" generally means physically
coupled or linked and does not exclude the presence of intermediate
elements between the coupled items absent specific contrary
language.
In view of the many possible embodiments to which the principles of
this disclosure may be applied, it should be recognized that the
illustrated embodiments are only preferred examples and should not
be taken as limiting the scope of the disclosure.
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