U.S. patent application number 12/776225 was filed with the patent office on 2010-11-18 for knotless suture anchor and methods of use.
This patent application is currently assigned to Foundry Newco XI, Inc.. Invention is credited to Mark Deem, Darin C. Gittings, Jeffry J. Grainger, Michael Hendricksen, Mark Hirotsuka.
Application Number | 20100292733 12/776225 |
Document ID | / |
Family ID | 43069139 |
Filed Date | 2010-11-18 |
United States Patent
Application |
20100292733 |
Kind Code |
A1 |
Hendricksen; Michael ; et
al. |
November 18, 2010 |
KNOTLESS SUTURE ANCHOR AND METHODS OF USE
Abstract
Various devices, systems and methods for knotless suturing of
tissue are disclosed. These devices allow sutures to be anchored to
bone, and more specifically provide a suture anchor which
eliminates the need for knotting the suture. Thus, damaged tissue
may be re-attached to a substrate tissue. The anchors have a
minimum of moving parts may be suited to being a single molded
polymer construction. The anchors will find particular utility in
hip and shoulder arthroscopy, e.g. labral re-attachment and similar
procedures.
Inventors: |
Hendricksen; Michael;
(Redwood City, CA) ; Hirotsuka; Mark; (San Jose,
CA) ; Deem; Mark; (Mountain View, CA) ;
Grainger; Jeffry J.; (Portola Valley, CA) ; Gittings;
Darin C.; (Sunnyvale, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER, EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
Foundry Newco XI, Inc.
Menlo Park
CA
|
Family ID: |
43069139 |
Appl. No.: |
12/776225 |
Filed: |
May 7, 2010 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61304352 |
Feb 12, 2010 |
|
|
|
61298780 |
Jan 27, 2010 |
|
|
|
61263728 |
Nov 23, 2009 |
|
|
|
61263751 |
Nov 23, 2009 |
|
|
|
61219290 |
Jun 22, 2009 |
|
|
|
61177602 |
May 12, 2009 |
|
|
|
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0416 20130101;
A61B 2017/0448 20130101; A61B 2017/0445 20130101; A61B 2017/045
20130101; A61B 2017/06142 20130101; A61B 2090/0807 20160201; A61B
2017/0496 20130101; A61B 17/0482 20130101; A61B 17/06166 20130101;
A61B 90/92 20160201; A61B 2017/0438 20130101; A61B 2017/0461
20130101; A61B 17/0401 20130101; A61B 2017/0441 20130101; B29C
45/00 20130101; A61B 2017/0412 20130101; A61B 2017/0432 20130101;
A61B 2017/044 20130101; A61B 2017/0451 20130101; A61B 2017/0409
20130101; A61B 2017/0454 20130101; A61B 2017/0414 20130101; A61B
2017/0453 20130101; A61B 2017/0433 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A knotless suture anchoring system, said system comprising: a
first anchor positionable in tissue and having a longitudinal axis;
a cinching mechanism coupled to the first anchor, the cinching
mechanism comprising a body having first and second transverse
apertures spaced apart along the longitudinal axis and separated by
a bar; and a length of suture threaded through the first and second
apertures so as to form a loop around the bar, the suture having
first and second extremities extending respectively from the first
and second apertures on the same side of the body, the first and
second extremities being generally parallel to and overlying one
another such that the second extremity is sandwiched between the
first extremity and the body, wherein exerting tension on the first
extremity compresses the second extremity against the body to
prevent movement of the suture relative to the body, and wherein
exerting tension on the second extremity allows the suture to move
longitudinally relative to the body.
2. The system of claim 1, wherein the suture comprises a flat
cross-sectional profile.
3. The system of claim 1, wherein the suture comprises a round
cross-sectional profile.
4. The system of claim 2, wherein the anchor has a proximal end, a
distal end, and the longitudinal axis extends therebetween, the
first and second apertures extending through the body in a
direction transverse to the longitudinal axis.
5. The system of claim 1, wherein the cinching mechanism is
positioned in a central channel of the anchor.
6. The system of claim 5, wherein the anchor has a proximal end, a
distal end, and the longitudinal axis extends therebetween, the
central channel being aligned with the longitudinal axis, the
channel having an opening at the proximal end, and wherein at least
one of the first and second extremities extend through the
opening.
7. The system of claim 1, wherein the apertures are disposed along
the body in a single line substantially parallel with the
longitudinal axis.
8. The system of claim 1, wherein the body comprises a plate and
the first and second apertures comprise slots extending through the
plate.
9. The system of claim 8, wherein the anchor has a proximal end, a
distal end, and the longitudinal axis extends therebetween, the
plate being oriented generally parallel to the longitudinal
axis.
10. The system of claim 8, wherein the plate is disposed in a
central channel of the anchor.
11. The system of claim 1, wherein the body has a face against
which the second extremity is compressed, the bar being laterally
offset from the face.
12. The system of claim 1, wherein the body has a face against
which the second extremity is compressed, the first aperture
intersecting the face so as to define a corner which engages the
second extremity.
13. The system of claim 12, wherein the corner has an edge which
locks the second extremity when the first extremity is
tensioned.
14. The system of claim 12, wherein the corner defines an angle of
no more than about 90 degrees.
15. The system of claim 12, wherein the face comprises one or more
features to induce friction with the second extremity when the
first extremity is tensioned.
16. The system of claim 1, wherein the body comprises a barrel
disposed in an aperture in a sidewall of the anchor transverse to
the longitudinal axis of the anchor.
17. The system of 16, wherein the barrel is rotatably disposed in
the sidewall aperture, the rotatable barrel having a locked
position and an unlocked position, the unlocked position allowing
the suture to move, the locked position constraining movement of
the suture.
18. The system of claim 17, wherein the apertures extend through
the barrel parallel to a first axis, and in the unlocked position,
the first and second extremities extend from the apertures
substantially parallel to the first axis.
19. The system of claim 17, wherein the apertures extend through
the barrel parallel to a first axis, and in the locked position,
the first and second extremities extend from the apertures in a
direction transverse to the first axis.
20. The system of claim 1, wherein the cinching mechanism is
integral with the first anchor.
21. The system of claim 20, wherein the cinching mechanism and the
first anchor are a single molded part.
22. The system of claim 1, wherein the cinching mechanism is on a
separate member configured to be attached to the first anchor at a
surgical site.
23. The system of claim 1, wherein the cinching mechanism is
coupled to a second anchor adapted for being positioned in tissue
and which may be coupled to the first anchor.
24. The system of claim 1, wherein the cinching mechanism requires
no movement of parts relative to the first anchor to prevent the
suture from moving when the first extremity is tensioned.
25. The system of claim 1, wherein the cinching mechanism is a
single molded part.
26. The system of claim 1, wherein the first anchor has an outer
diameter which is no more than about 3.5 mm along its entire
length.
27. The system of claim 1, further comprising a second anchor
positionable in the tissue.
28. The system of claim 27, wherein one of the two anchors is
positioned concentrically in the other of the two anchors.
29. The system of claim 27, wherein one of the two anchors is
positioned end to end with the other of the two anchors.
30. A knotless suture anchoring system, said system comprising: a
first anchor component having a longitudinal axis and a first
cinching mechanism; a second anchor component initially detached
from the first anchor component, at least one of the first and
second anchor components being adapted for placement directly into
bone or other tissue and comprising a retention feature on an
exterior surface thereof for retaining the first or second anchor
component in said bone or tissue; a coupling mechanism for coupling
the second anchor component to the first anchor component; and a
length of suture at least partially disposed in the first cinching
mechanism, the suture having a free end, wherein the first cinching
mechanism allows the suture to pass through the first cinching
mechanism in a first direction when the free end is tensioned and
constrains movement of the suture through the first cinching
mechanism in a second direction opposite the first direction.
31. A knotless suture anchor system as in claim 30, wherein the
second anchor component is received within a cavity in the first
anchor component.
32. A knotless suture anchor system as in claim 30, wherein the
first anchor component is received within a cavity in the second
anchor component.
33. A knotless suture anchor system as in claim 30, wherein the
first anchor component is coupled end-to-end with the second anchor
component.
34. A knotless suture anchor system as in claim 30, wherein the
suture has a second end coupled to the second anchor component.
35. A knotless suture anchor system as in claim 30, wherein the
first cinching mechanism has no parts movable relative to the first
anchor component.
36. A knotless suture anchor system as in claim 30, further
comprising a second cinching mechanism coupled to the second anchor
component, the suture having a second end coupled to the second
cinching mechanism.
37. A knotless suture anchor system as in claim 30, wherein the
second anchor component has a suture retention structure for
retaining a second end of the suture therein.
38. A knotless suture anchor system as in claim 30, wherein the
first anchor component and the first cinching mechanism are an
integral molded construction.
39. A knotless suture anchoring system, said system comprising: a
first anchor having a proximal end and a distal end, and being
positionable in tissue; a second anchor having a proximal end and a
distal end; a first cinching mechanism coupled to either the first
anchor or the second anchor; a coupling element attached to one or
both of the first and second anchors and adapted to couple the
first and the second anchors together end-to-end; and a length of
suture coupled to either the first anchor or the second anchor, the
suture having a free end and being at least partially disposed in
the first cinching mechanism, wherein the first cinching mechanism
is adapted to allow the suture to be tensioned by pulling the free
end so that the suture passes through the first cinching mechanism
in a first direction while movement of the suture through the first
cinching mechanism in a second direction opposite the first
direction is constrained.
40. The system of claim 39, wherein the coupling element comprises
a threaded post, and wherein the first anchor is threadably engaged
with the second anchor.
41. The system of claim 39, wherein the coupling element comprises
a post having a plurality of barbs disposed thereon.
42. The system of claim 39, wherein the coupling element comprises
a compression fitting.
43. The system of claim 39, wherein the suture is fixed to the
first anchor and the cinching mechanism is on the second
anchor.
44. The system of claim 43, wherein each of the first and second
anchors is adapted to be placed in tissue separately from the other
of the first and second anchors.
45. A method for re-joining damaged tissue with substrate tissue,
said method comprising: providing a suture coupled with a first
anchor and a second anchor; positioning the first anchor in the
substrate tissue; capturing the damaged tissue with the suture;
positioning the second anchor in the substrate tissue, the second
anchor axially aligned end-to-end with the first anchor; and
adjusting the length of the suture so that the damaged tissue is
apposed to the substrate tissue.
46. The method of claim 45, wherein the substrate tissue comprises
bone and the step of positioning the first anchor in the substrate
tissue comprises drilling a hole in the bone followed by
positioning the first anchor therein.
47. The method of claim 45, wherein the step of positioning the
first anchor comprises advancing the first anchor from an elongate
shaft of a delivery instrument.
48. The method of claim 45, wherein the step of capturing the
damaged tissue comprises at least partially encircling the damaged
tissue with the suture.
49. The method of claim 45, wherein the step of capturing comprises
passing at least one of the suture anchors through a penetration in
the damaged tissue.
50. The method of claim 45, wherein the step of positioning the
second anchor comprises coupling the first anchor with the second
anchor.
51. The method of claim 50, wherein the step of coupling comprises
interconnecting a proximal region of the first anchor with a distal
region of the second anchor.
52. The method of claim 50, wherein the step of coupling comprises
engaging a plurality of threads or ribs on a proximal end of the
first anchor with the second anchor.
53. The method of claim 45, wherein the step of adjusting the
length comprises pulling the suture through a cinching mechanism
disposed in either the first or the second anchor, the cinching
mechanism adapted to allow the suture to move in a first direction,
while the suture is constrained from moving in a second direction
opposite the first direction.
54. A method for anchoring suture to substrate tissue, said method
comprising: drilling a first hole into the substrate tissue;
placing a suture anchor into the first hole, the suture anchor
coupled to a first extremity of a suture; capturing damaged tissue
with the suture, wherein the damaged tissue obstructs visualization
of the first hole; transmitting light through the damaged tissue
such that the first hole is visible therethrough; and coupling a
second extremity of the suture to the first anchor.
55. The method of claim 54, wherein the second extremity of the
suture is coupled to an anchor component and coupling the second
extremity comprises coupling the anchor component to the first
anchor.
56. The method of claim 55, wherein the anchor component is
inserted concentrically in the first anchor.
57. The method of claim 55, wherein the anchor component is coupled
end-to-end with the first anchor.
58. The method of claim 55, wherein at least one of the first
anchor and the anchor component has a cinching mechanism which
allows the suture to move in a first direction and constrains the
suture from moving in a second direction opposite the first
direction, the method further comprising tightening the suture by
pulling it through the cinching mechanism.
59. The method of claim 54 wherein the first anchor is placed by
means of a delivery instrument to which the first anchor is
releasably coupled, and the light is transmitted from a light
emission device coupled to the delivery instrument.
60. The method of claim 54, wherein the substrate tissue comprises
an acetabular or glenoid rim.
61. The method of claim 54, wherein the damaged tissue comprises a
torn labrum.
62. A method for fabricating a suture anchor, said method
comprising: molding the suture anchor from a polymer, the suture
anchor being of a unitary construction without moving parts and
having a cinching mechanism adapted to allow a suture to pass
therethrough in a first direction while movement of the suture in a
second direction opposite the first direction is constrained.
63. A knotless suture anchoring system, said system comprising: a
first anchor having a proximal end, a distal end, a central channel
extending therebetween, and positionable in tissue; a tissue
piercing needle positionable in the central channel; a first
cinching mechanism coupled to either the first anchor or the tissue
piercing needle; a coupling element attached to the first anchor or
the tissue piercing needle, the coupling element adapted to couple
the first anchor and the tissue piercing needle together when the
tissue piercing needle is positioned in the central channel; and a
length of suture coupled to the first anchor and the tissue
piercing needle, the suture having a free end and at least
partially disposed in the first cinching mechanism, wherein the
first cinching mechanism is adapted to allow the suture to be
tensioned by pulling the free end so that the suture passes through
the first cinching mechanism in a first direction while movement of
the suture through the first cinching mechanism in a second
direction opposite the first direction is constrained.
64. The system of claim 63, wherein the suture is tied to the first
anchor and wherein the first cinching mechanism is coupled to the
tissue piercing needle.
65. The system of claim 63, wherein the coupling element comprises
a snap fit between the tissue piercing element and the first
anchor.
66. The system of claim 63, wherein the distal end of the first
anchor comprises a plurality of slits parallel with a longitudinal
axis of the first anchor, the slits forming a plurality of
deflectable arms in the anchor.
67. The system of claim 63, wherein an outer surface of the first
anchor comprises a plurality of barbs.
68. The system of claim 63, wherein the tissue piercing needle
comprises a central channel substantially parallel with a
longitudinal axis of the needle.
69. The system of claim 63, wherein the suture is fixedly attached
to the tissue piercing needle, and wherein the first cinching
mechanism is coupled with the first anchor.
70. A method for re-joining damaged tissue with a substrate tissue,
said method comprising: providing a suture anchor system having an
anchor, a tissue piercing needle, and a suture coupled to the
anchor and the needle; positioning the anchor in the substrate
tissue; piercing the damaged tissue with the needle; passing the
suture through the damaged tissue; coupling the needle to the
anchor; and adjusting the length of the suture so that the damaged
tissue is apposed to the substrate tissue.
71. The method of claim 70, wherein the substrate tissue comprises
bone and the step of positioning the first anchor comprises
drilling a hole in the bone followed by positioning of the first
anchor therein.
72. The method of claim 70, wherein the step of positioning the
first anchor comprises advancing the first anchor from an elongate
shaft of a delivery instrument.
73. The method of claim 70, further comprising at least partially
encircling the damaged tissue with the suture.
74. The method of claim 70, wherein the step of adjusting the
length comprises pulling the suture through a cinching mechanism
disposed in either the first anchor or the tissue piercing needle,
the cinching mechanism adapted to allow the suture to move in a
first direction, while the suture is constrained from moving in a
second direction opposite the first direction.
75. The method of claim 70, wherein the damaged tissue comprises a
torn labrum.
76. The method of claim 70, wherein the step of coupling comprises
positioning the tissue piercing needle in a central channel of the
first anchor.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a non-provisional of, and claims
the benefit of U.S. Provisional Patent Application Nos. 61/177,602
(Attorney Docket No. 028357-000110US, formerly 020979-003910US),
filed May 12, 2009; 61/219,290 (Attorney Docket No.
028357-000200US, formerly 020979-004700US), filed Jun. 22, 2009;
61/263,728 (Attorney Docket No. 028357-000210US, formerly
020979-004710US), filed Nov. 23, 2009; 61/263,751 (Attorney Docket
No. 028357-000220US, formerly 020979-004720US), filed Nov. 23,
2009; 61/298,780 (Attorney Docket No. 028357-000230US, formerly
020979-004730US), filed Jan. 27, 2010; and 61/304,352 (Attorney
Docket No. 028357-000240US, formerly 020979-004740US), filed Feb.
12, 2010; the entire contents of each of the above listed patent
applications is incorporated herein by reference.
[0002] The present application is also related to U.S. patent
application Ser. Nos. 12/605,065 (Attorney Docket No.
028357-000120US, formerly 020979-003920US), filed Oct. 23, 2009;
Ser. No. ______ (Attorney Docket No. 028357-000130), filed
concurrently with the present application; and Ser. No. ______
(Attorney Docket No. 028357-000250US), also filed concurrently with
the present application; each of which, the entire contents are
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The present disclosure relates to medical devices, systems
and methods, and more specifically to methods, systems and devices
used for knotless suturing of tissue.
[0005] Soft tissue such as tendons, ligaments and cartilage are
generally attached to bone by small collagenous fibers which are
strong, but which nevertheless still can tear due to wear or
disease. Examples of musculoskeletal disease include a torn rotator
cuff as well as a torn labrum in the acetabular rim of a hip joint
or the glenoid rim in a shoulder joint.
[0006] Thus, treatment of musculoskeletal disease may involve
reattachment of torn ligaments, tendons or other tissue to bone.
This may require the placement of devices such as suture anchors
within bone. A suture anchor is a device which allows a suture to
be attached to tissue such as bone. Suture anchors may include
screws or other tubular fasteners which are inserted into the bone
and anchored in place. After insertion of the anchor, the tissue to
be repaired is captured by a suture, the suture is attached to the
anchor (if not already pre-attached), tension is adjusted, and then
the suture is often knotted so that the tissue is secured in a
desired position.
[0007] Most conventional suture anchors require the surgeon to tie
knots in the suture to secure the target tissue to the bone after
the anchor is placed. Knot tying can be difficult during surgery,
particularly if working in a confined space through cannulas or
other surgical ports as in arthroscopic surgery. Therefore, it
would be desirable to provide knotless suture anchor systems.
[0008] Additionally, many surgeons prefer to use polymeric anchors
rather than metal ones so that the anchors are compatible with the
use of MRI. While polymeric anchors are available, they do not have
the knotless suture securing capabilities described above. This may
be in part due to challenges of fabricating polymer anchors that
provide a reliable cinching mechanism for a knotless anchor at the
small scale required for orthopedic procedures. Further, while it
is frequently advantageous to fabricate polymeric devices by
molding, known knotless anchor designs require multiple moving
parts and geometries which are not suitable for molding. Therefore
it would be advantageous to provide a knotless anchor with the
characteristics described above and which is also suitable to being
molded with a polymer as a single integral part or as series of
molded components that can be easily assembled together. By single
integral part, it is meant that the entire part is formed from a
single piece of material or molded as a single piece, without need
for fastening, bonding, welding or otherwise interconnecting
multiple components together. Examples of this include, but are not
limited to, single-piece components that are injection molded,
cast, or machined from a single block of material. The word
"molded" is intended to encompass materials which are injection
molded, blow molded, compression molded, thermoformed, or made
using other molding processes known to those of skill in the art,
useful for shaping polymers, ceramics, or other formable
materials.
[0009] Frequently two or more anchors and multiple lengths of
suture are required. Using such devices can be time consuming and
difficult to undertake in the tight space encountered during
endoscopic surgery and sometimes even in conventional open surgery.
Recently, knotless suture anchors having suture clamping mechanisms
have been developed to eliminate the need to tie knots but they
still can be difficult or awkward to use.
[0010] Some knotless suture anchors have been devised which allow
the suture to be cinched and secured without tying a knot, however
these typically rely upon trapping the suture between the anchor
and the bone to secure the suture, which means the anchor cannot be
fully inserted into the bone until the tissue has been captured and
secured tightly. The process of maintaining tension on the suture,
keeping the tissue at the desired location and simultaneously
inserting the anchor into the bone is difficult. Other knotless
anchors rely on the manual actuation of some type of moving part on
the anchor to clamp or trap the suture within the anchor, requiring
an extra hand that the surgeon may not have available. It would be
desirable to allow the anchor to be fully inserted in the bone
prior to securing the tissue and to avoid the requirement of extra
manipulations to secure the suture.
[0011] Thus, it would be desirable to provide improved knotless
suture anchors that are easier to use and also that may take up
less space during deployment and that are easier to deploy.
[0012] In particular, treating musculoskeletal disease in a hip
joint can be especially challenging. The hip joint is a deep joint
surrounded by a blanket of ligaments and tendons that cover the
joint, forming a sealed capsule. The capsule is very tight thereby
making it difficult to advance surgical instruments past the
capsule into the joint space. Also, because the hip joint is a deep
joint, delivery of surgical instruments far into the joint space
while still allowing control of the working portions of the
instrument from outside the body can be challenging. Additionally,
the working space in the joint itself is very small and thus there
is little room for repairing the joint, such as when reattaching a
torn labrum to the acetabular rim. Moreover, when treating a torn
labrum, the suture anchor must be small enough to be inserted into
the healthy rim of bone with adequate purchase, and the anchor also
must be short enough so that it does not protrude through the bone
into the articular surface of the joint (e.g. the acetabulum).
Existing anchors may be used to repair the labrum, but are not
well-suited to labral repair especially in the hip. First, the
reattachment of the labrum to the acetabular rim is most effective
if both ends of the suture are attached to the same point in the
bone. This provides the most precise and secure apposition of the
labrum to the rim. The space available on the acetabular rim is
very limited, typically requiring an anchor with a transverse
dimension (e.g. diameter) preferably less than 4 mm and no more
than about 3.5 mm and therefore many commercially available anchors
are too large. Thus, it would be desirable to provide suture
anchors that have a small diameter and length.
[0013] Additionally, existing knotless anchors are typically
designed for use in rotator cuff repair in the shoulder and they
are intended for placement in separate holes in the bone. These
devices have no mechanism for coupling one anchor to the other
within the same hole, cannot be implanted concentrically within the
hole, and are too long for stacking within the same hole. Further,
many existing knotless anchors are too large for placement on the
acetabular rim for labral repair of the hip.
[0014] In addition, existing knotless anchors and interconnecting
anchors have suture locking mechanisms which have moving parts and
other complex designs that are not reliably manufacturable at the
small scale required for labral repair anchors. While various types
of anchors with suture locking mechanisms have been disclosed, many
of these cannot be made in an anchor less than 4 mm, and no more
than 3.5 mm in diameter.
[0015] Moreover, because of the difficulty of performing labral
repairs arthroscopically, it is highly desirable to minimize the
manipulations of the suture and anchor that are required
intraoperatively. Many existing knotless anchors require the
surgeon, after initial anchor placement and capture of the labrum,
to thread the free end of the suture through the anchor or a
component of the anchor, which is difficult and takes an excessive
amount of time. Some anchors further require the surgeon to push
the anchor further into bone, or push a locking mechanism on the
anchor, or perform some other manipulation of the anchor in order
to lock the suture. These manipulations add difficulty and time to
arthroscopic labral repair that would be desirably avoided.
[0016] Therefore, it would be desirable to provide improved
knotless suture anchors that are ideally suited to arthroscopic
procedures, and in particular labral repair in the hip. The anchors
would preferably be adapted for placement in a single hole in the
bone, extremely simple in design with few or no moving parts,
manufacturable at very small scale (e.g. diameter less than 4 mm,
and preferably no more than 3.5 mm), and require no manipulation of
the suture or the anchor itself in order to operate the suture
locking mechanism. The anchors should further require no
intraoperative threading of the suture ends or other manipulation
of the suture either before or after initial anchor placement.
[0017] Thus, there is a need for improved devices, systems and
methods which overcome some of the aforementioned challenges. At
least some of these objectives will be met by the inventions
described hereinbelow.
[0018] 2. Description of the Background Art
[0019] Patents disclosing suture anchoring devices and related
technologies include U.S. Pat. Nos. 7,566,339; 7,390,329;
7,309,337; 7,144,415; 7,083,638; 6,986,781; 6,855,157; 6,770,076;
6,767,037; 6,656,183; 6,652,561; 6,066,160; 6,045,574; 5,810,848;
5,728,136; 5,702,397; 5,683,419; 5,647,874; 5,630,824; 5,601,557;
5,584,835; 5,569,306; 5,520,700; 5,486,197; 5,464,427; 5,417,691;
and 5,383,905. Patent publications disclosing such devices include
U.S. Patent Publication Nos. 2009/0069845 and 2008/0188854 and PCT
Publication No. 2008/054814.
BRIEF SUMMARY OF THE INVENTION
[0020] The present invention provides devices, systems and method
for knotless suturing of tissue. Exemplary procedures where
knotless suturing may be advantageous include repair of torn
rotator cuffs, as well as a torn labrum in the acetabular rim of a
hip joint or the glenoid rim in a shoulder joint. The invention
relates to suture anchors for anchoring sutures to bone, and more
specifically provides a suture anchor which eliminates the need for
knotting the suture and which is suited to being a molded polymer
construction. The anchors will find particular utility in hip and
shoulder arthroscopy, e.g. labral reattachment and similar
procedures.
[0021] In a first aspect of the present invention, a knotless
suture anchoring system comprises a first anchor positionable in
tissue and having a longitudinal axis. The system also has a
cinching mechanism coupled to the first anchor. The cinching
mechanism comprises a body having first and second transverse
apertures spaced apart along the longitudinal axis and separated by
a bar. A length of suture is threaded through the first and second
apertures so as to form a loop around the bar. The suture has first
and second extremities extending respectively from the first and
second apertures on the same side of the body, and the first and
second extremities are generally parallel to and lie over one
another such that the second extremity is sandwiched between the
first extremity and the body. Exerting tension on the first
extremity compresses the second extremity against the body to
prevent movement of the suture relative to the body. Also, exerting
tension on the second extremity allows the suture to move
longitudinally relative to the body.
[0022] The suture may comprise a flat cross-sectional profile, a
round cross-sectional profile, or any other profile. The anchor has
a proximal end, a distal end, and the longitudinal axis extends
therebetween. The first and second apertures may extend through the
body in a direction transverse to the longitudinal axis. The
central channel may be aligned with the longitudinal axis, and the
channel may have an opening at the proximal end. At least one of
the first and second extremities of suture may extend through the
opening. The cinching mechanism may be positioned in a central
channel of the anchor. The apertures may be disposed along the body
in a single line substantially parallel with the longitudinal axis.
The body may comprise a plate and the first and second apertures
comprise slots extending through the plate. The plate may be
oriented generally parallel to the longitudinal axis. The plate may
be disposed in a central channel of the anchor.
[0023] The body may have a face against which the second extremity
is compressed, and the bar may be laterally offset from the face.
The first aperture may intersect the face so as to define a corner
which engages the second extremity. The corner may have an edge
which locks the second extremity when the first extremity is
tensioned. The corner may define an angle of no more than about 90
degrees. The face may comprise one or more features to induce
friction with the second extremity when the first extremity is
tensioned.
[0024] The body may comprise a barrel disposed in an aperture in a
sidewall of the anchor transverse to the longitudinal axis of the
anchor. The barrel may be rotatably disposed in the sidewall
aperture, and the rotatable barrel may have a locked position and
an unlocked position. The unlocked position may allow the suture to
move, and the locked position may constrain movement of the suture.
The apertures may extend through the barrel parallel to a first
axis, and in the unlocked position, the first and second
extremities may extend from the apertures substantially parallel to
the first axis. In the locked position, the first and second
extremities extend from the apertures in a direction transverse to
the first axis.
[0025] The cinching mechanism may be a single molded part, and may
be integral with the first anchor. The cinching mechanism and the
first anchor may be a single molded part. The cinching mechanism
may be on a separate member that is configured to be attached to
the first anchor at a surgical site. The cinching mechanism may be
coupled to a second anchor adapted for positioning in tissue and
which may be coupled to the first anchor. The cinching mechanism
may require no movement of parts relative to the first anchor to
prevent the suture from moving when the first extremity is
tensioned.
[0026] The first anchor may have an outer diameter which is less
than 4 mm and no more than about 3.5 mm along its entire length.
The system may further comprise a second anchor that is
positionable in the tissue. One of the two anchors may be
positionable concentrically in the other of the two anchors, or one
of the two anchors may be positioned end to end with the other of
the two anchors.
[0027] In another aspect of the present invention, a knotless
suture anchoring system comprises a first anchor component having a
longitudinal axis and a first cinching mechanism. A second anchor
component is initially detached from the first anchor component,
and at least one of the first and second anchor components are
adapted for placement directly into bone or other tissue and
comprise a retention feature on an exterior surface thereof for
retaining the first or second anchor component in the bone or
tissue. The system also has a coupling mechanism for coupling the
second anchor component to the first anchor component, and a length
of suture at least partially disposed in the first cinching
mechanism. The suture has a free end, and the first cinching
mechanism allows the suture to pass through the first cinching
mechanism in a first direction when the free end is tensioned and
constrains movement of the suture through the first cinching
mechanism in a second direction opposite the first direction.
[0028] The second anchor component may be received within a cavity
in the first anchor component. The first anchor component may be
received within a cavity in the second anchor component. The first
anchor component may be coupled end-to-end with the second anchor
component. The suture may have a second end coupled to the second
anchor component. The first cinching mechanism may have no parts
movable relative to the first anchor component. The system may
further comprise a second cinching mechanism coupled to the second
anchor component. The suture may have a second end that is coupled
to the second cinching mechanism. The second anchor component may
have a suture retention structure for retaining a second end of the
suture therein. The first anchor component and the first cinching
mechanism may be an integral molded construction.
[0029] In another aspect of the present invention, a knotless
suture anchoring system comprises a first anchor having a proximal
end and a distal end, and being positionable in tissue. A second
anchor also has a proximal end and a distal end, and a first
cinching mechanism is coupled to either the first anchor or the
second anchor. A coupling element is attached to one or both of the
first and second anchors and is adapted to couple the first and the
second anchors together end-to-end. A length of suture is coupled
to either the first anchor or the second anchor. The suture has a
free end and is at least partially disposed in the first cinching
mechanism. The first cinching mechanism is adapted to allow the
suture to be tensioned by pulling the free end so that the suture
passes through the first cinching mechanism in a first direction
while movement of the suture through the first cinching mechanism
in a second direction opposite the first direction is
constrained.
[0030] The coupling element may comprise a threaded post, and the
first anchor may be threadably engaged with the second anchor. The
coupling element may comprise a post having a plurality of barbs
disposed thereon, or the coupling element may comprise a
compression fitting. The suture may be fixed to the first anchor
and the cinching mechanism may be on the second anchor. Each of the
first and second anchors may be placed in tissue separately from
the other of the first and second anchors.
[0031] In still another aspect of the present invention, a method
for re-joining damaged tissue with substrate tissue comprises
providing a suture coupled with a first anchor and a second anchor,
and positioning the first anchor in the substrate tissue. The
method also includes capturing the damaged tissue with the suture,
and positioning the second anchor in the substrate tissue. The
second anchor is axially aligned end-to-end with the first anchor.
Adjusting the length of the suture apposes the damaged tissue with
the substrate tissue.
[0032] The substrate tissue may comprise bone and the step of
positioning the first anchor in the substrate tissue may comprise
drilling a hole in the bone followed by positioning the first
anchor therein. The step of positioning the first anchor may
comprise advancing the first anchor from an elongate shaft of a
delivery instrument. Capturing the damaged tissue may comprise at
least partially encircling the damaged tissue with the suture.
Capturing may also comprise passing at least one of the suture
anchors through a penetration in the damaged tissue. Positioning
the second anchor may comprise coupling the first anchor with the
second anchor. Coupling the first and second anchors may comprise
interconnecting a proximal region of the first anchor with a distal
region of the second anchor. Coupling may also comprise engaging a
plurality of threads or ribs on a proximal end of the first anchor
with the second anchor. Adjusting the length of the suture may
comprise pulling the suture through a cinching mechanism disposed
in either the first or the second anchor. The cinching mechanism
may be adapted to allow the suture to move in a first direction,
while the suture is constrained from moving in a second direction
opposite the first direction.
[0033] In another aspect of the present invention, a method for
anchoring suture to substrate tissue comprises drilling a first
hole into the substrate tissue, and placing a suture anchor into
the first hole. The suture anchor is coupled to a first extremity
of a suture. The method also includes capturing damaged tissue with
the suture. The damaged tissue obstructs visualization of the first
hole, so transmitting light through the damaged tissue allows
visualization of the first hole through the tissue. A second
extremity of the suture is then coupled to the first anchor.
[0034] The second extremity of the suture may be coupled to an
anchor component and coupling the second extremity may comprise
coupling the anchor component to the first anchor. The anchor
component may be inserted concentrically in the first anchor, or
the anchor component may be coupled end-to-end with the first
anchor. At least one of the first anchor and the anchor component
may have a cinching mechanism which allows the suture to move in a
first direction and constrains the suture from moving in a second
direction opposite the first direction. The method may comprise
tightening the suture by pulling it through the cinching mechanism.
The first anchor may be placed by means of a delivery instrument to
which the first anchor is releasably coupled. The light may be
transmitted from a light emission device coupled to the delivery
instrument. The substrate tissue may comprise an acetabular or
glenoid rim and the damaged tissue may comprise a torn labrum.
[0035] In another aspect of the present invention, a method for
fabricating a suture anchor comprises molding the suture anchor
from a polymer. The suture anchor may be of a unitary construction
without moving parts and may have a cinching mechanism adapted to
allow a suture to pass therethrough in a first direction while
movement of the suture in a second direction opposite the first
direction is constrained.
[0036] In yet another aspect of the present invention, a knotless
suture anchoring system comprises a first anchor having a proximal
end, a distal end, a central channel extending therebetween, and
positionable in tissue. A tissue piercing needle is positionable in
the central channel, and a first cinching mechanism is coupled to
either the first anchor or the tissue piercing needle. A coupling
element is attached to the first anchor or the tissue piercing
needle. The coupling element is adapted to couple the first anchor
and the tissue piercing needle together when the tissue piercing
needle is positioned in the central channel. A length of suture is
coupled to the first anchor and the tissue piercing needle. The
suture has a free end and is at least partially disposed in the
first cinching mechanism. The first cinching mechanism is adapted
to allow the suture to be tensioned by pulling the free end so that
the suture passes through the first cinching mechanism in a first
direction while movement of the suture through the first cinching
mechanism in a second direction opposite the first direction is
constrained.
[0037] The suture may be tied to the first anchor and the first
cinching mechanism may be coupled to the tissue piercing needle.
The coupling element may comprise a snap fit between the tissue
piercing element and the first anchor. The distal end of the first
anchor may comprise a plurality of slits parallel with a
longitudinal axis of the first anchor. The slits may form a
plurality of deflectable arms in the anchor. An outer surface of
the first anchor may comprise a plurality of barbs. The tissue
piercing needle may comprise a central channel that is
substantially parallel with a longitudinal axis of the needle. The
suture may be fixedly attached to the tissue piercing needle, and
the first cinching mechanism may be coupled with the first
anchor.
[0038] In another aspect of the present invention, a method for
re-joining damaged tissue with a substrate tissue comprises
providing a suture anchor system having an anchor, a tissue
piercing needle, and a suture coupled to the anchor and the needle.
The anchor is positioned in the substrate tissue, and the damaged
tissue is pierced with the needle. The suture is passed through the
damaged tissue, and the needle is coupled with the anchor. Suture
length is then adjusted so that the damaged tissue is apposed with
the substrate tissue.
[0039] The substrate tissue may comprise bone and the step of
positioning the first anchor may comprise drilling a hole in the
bone followed by positioning of the first anchor therein. The step
of positioning the first anchor may comprise advancing the first
anchor from an elongate shaft of a delivery instrument. The method
may further comprise at least partially encircling the damaged
tissue with the suture, and the step of adjusting the length may
comprise pulling the suture through a cinching mechanism disposed
in either the first anchor or the tissue piercing needle. The
cinching mechanism may be adapted to allow the suture to move in a
first direction, while the suture is constrained from moving in a
second direction opposite the first direction. The damaged tissue
may comprise a torn labrum. The coupling step may comprise
positioning the tissue piercing needle in a central channel of the
first anchor.
[0040] These and other embodiments are described in further detail
in the following description related to the appended drawing
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] FIG. 1 illustrates basic anatomy of the hip.
[0042] FIG. 2 illustrates a top view of the hip.
[0043] FIGS. 3-4 illustrate an exemplary method of reattaching a
torn labrum to the acetabular rim.
[0044] FIGS. 5A-5C illustrate dimensional constraints of a suture
anchor used in the hip joint.
[0045] FIGS. 6A-6D illustrate an exemplary method of placing suture
anchors into a hip joint.
[0046] FIG. 7 illustrates suture anchors positioned end-to-end.
[0047] FIGS. 8-16 illustrate exemplary suture anchor
configurations.
[0048] FIGS. 17A-17D illustrate an exemplary suture anchor.
[0049] FIG. 18 illustrates another exemplary suture anchor.
[0050] FIGS. 19-20 illustrate exemplary embodiments of suture
anchor coupling mechanisms.
[0051] FIGS. 21A-21B illustrate an exemplary embodiment of a
cinching mechanism.
[0052] FIGS. 22A-22B illustrate another exemplary embodiment of a
cinching mechanism.
[0053] FIG. 23 illustrates another exemplary embodiment of a suture
anchor.
[0054] FIGS. 24A-24B illustrate still another exemplary embodiment
of a suture anchor.
[0055] FIGS. 25A-25B illustrate another exemplary embodiment of a
cinching mechanism.
[0056] FIGS. 26A-26C illustrate yet another exemplary embodiment of
a cinching mechanism.
[0057] FIGS. 27A-27F illustrate another exemplary embodiment of a
cinching mechanism.
[0058] FIGS. 28A-28C illustrate an exemplary embodiment of a
cinching mechanism.
[0059] FIGS. 29A-29C illustrate still another exemplary embodiment
of a cinching mechanism.
[0060] FIGS. 30A-30B illustrate yet another exemplary embodiment of
a cinching mechanism.
[0061] FIGS. 31A-31B illustrate another exemplary embodiment of a
cinching mechanism.
[0062] FIGS. 32A-32C illustrate another exemplary embodiment of a
cinching mechanism.
[0063] FIG. 33 illustrates another exemplary embodiment of a
cinching mechanism.
[0064] FIGS. 34A-34B illustrate another exemplary embodiment of a
cinching mechanism.
[0065] FIG. 35 illustrates another exemplary embodiment of a
cinching mechanism.
[0066] FIGS. 36A-36B illustrate an exemplary embodiment of a
cinching mechanism.
[0067] FIGS. 37A-37B illustrate an exemplary embodiment of a
cinching mechanism.
[0068] FIGS. 38A-38B illustrate an exemplary embodiment of a
cinching mechanism.
[0069] FIGS. 39-48 illustrate other exemplary embodiments of a
cinching mechanism.
[0070] FIGS. 49A-49C illustrate another exemplary embodiment of a
cinching mechanism.
[0071] FIGS. 50A-50C illustrate another exemplary embodiment of a
cinching mechanism.
[0072] FIGS. 51A-51C illustrate another exemplary embodiment of a
cinching mechanism.
[0073] FIGS. 52A-52B illustrate an exemplary embodiment of a
cinching mechanism.
[0074] FIG. 53 illustrates obstruction of a pre-drilled hole by
tissue.
[0075] FIG. 54 illustrates an exemplary method of visualizing a
pre-drilled hole.
[0076] FIG. 55 illustrates a suture anchor delivery instrument.
[0077] FIGS. 56A-56B illustrate an exemplary delivery
instrument.
[0078] FIG. 57 illustrates an exemplary delivery instrument.
[0079] FIGS. 58A-58H illustrate an exemplary method of suture
anchor delivery.
[0080] FIGS. 59A-59D illustrate an exemplary method of suture
anchor delivery.
[0081] FIGS. 60A-60B illustrate an exemplary delivery
instrument.
[0082] FIG. 61A-61C illustrate an exemplary delivery
instrument.
[0083] FIGS. 62A-62B illustrate an exemplary delivery
instrument.
[0084] FIG. 63 illustrates an exemplary delivery instrument.
[0085] FIGS. 64A-64H illustrate an exemplary method of suture
anchor delivery.
[0086] FIGS. 65A-65H illustrate an exemplary method of suture
anchor delivery.
[0087] FIGS. 66-69 illustrate exemplary embodiments of suture
anchor delivery.
[0088] FIGS. 70A-70B illustrate exemplary embodiments of suture
anchor delivery.
[0089] FIG. 71 illustrates an exemplary embodiment of suture anchor
delivery.
DETAILED DESCRIPTION OF THE INVENTION
[0090] Several exemplary embodiments of knotless suture anchors,
methods of use and delivery instruments are illustrated and
described in the attached figures.
[0091] Anatomy:
[0092] Exemplary use of the devices, systems and methods of the
present invention will be discussed primarily in terms of treatment
of a hip joint. However, one of skill in the art will appreciate
that other tissues may be re-attached to a base tissue or another
substrate in other areas of the body including joints such as the
shoulder joint, the ankle, wrist and other joints. Other areas may
also be treated with the devices, systems and methods disclosed
herein. Thus, the exemplary usage described herein is not intended
to be limiting. FIG. 1 illustrates the basic anatomy of a hip
joint. In FIG. 1 the hip joint is formed between the head of the
femur FH and the acetabulum A, a concave surface of the pelvis. A
blanket of ligaments cover the joint forming a capsule C.
Additionally the acetabular labrum L, a fibrocartilaginous lip,
surrounds the head of the femur, deepens the joint pocket and
increases the surface area of contact. The ligamentum teres LT is a
ligament attached to a depression in the acetabulum (the acetabular
notch or fossa) and a depression on the femoral head (the fovea of
the head). FIG. 2 is a top view of a hip joint highlighting the
labrum L.
[0093] The labrum L can tear or separate from the acetabular rim
due to wear or disease and this can result in pain as well as loss
of joint mobility. FIG. 3 illustrates a torn labrum 32. Surgeons
typically use suture and suture anchors to reattach the labrum to
the acetabular rim. The surgeon often wraps a free end of the
suture around the torn labrum and then the free end is threaded
through a suture anchor. The anchor is inserted into bone and the
suture length and/or tension is adjusted. FIG. 4 illustrates a torn
labrum after it has been reattached to the substrate acetabulum. A
suture anchor 42 with a suture 44 coupled thereto has been inserted
into the acetabulum A thereby fixing one end of the suture 44 to
the bone. The suture 44 is looped around the torn labrum 32 in
order to capture the damaged tissue. The other end of the suture is
also attached to the anchor and suture length has been adjusted in
order to draw the labrum toward the acetabulum, where it is held
until it heals and reattaches. Suture anchors are typically used
instead of screws, pins, rivets or other fasteners due to the
limited working space within the joint.
[0094] Referring now to FIGS. 5A-5C, the size of the suture anchor
can be very important depending on the treatment zone. For example,
when placing a suture anchor 54 into the acetabular rim 56 to
repair the labrum L, the anchor width or diameter 54a cannot exceed
the width 52 of the acetabular rim 56. Moreover, as shown in FIGS.
5A-5B, the anchor width 54a must be small enough relative to the
width of the acetabular rim 56 so that adequate purchase is
obtained without compromising strength of the rim 56. Thus, in most
anchor embodiments described below, the suture anchor width
(transverse to the anchor's longitudinal axis), or outer diameter
if the anchor has a round profile, is preferably less than about 4
mm and no more than about 3.5 mm. Additionally, length of the
anchor can also be critical. In FIG. 5B, the anchor 54 is placed
substantially orthogonally into the acetabular rim and thus the
anchor may be as long as necessary to obtain adequate purchase in
the bone without risk of extending into the joint socket. However,
it may be difficult to insert the anchor orthogonally into the
acetabular rim due to the angle of approach, the narrow width of
the rim, or for other reasons. In such cases, the anchor may be
placed at a non-perpendicular angle relative to the rim surface, or
it may be placed into a lateral facet of the acetabulum. In such
cases, if the anchor is either too long or the angle is too great
as shown in FIG. 5C, the anchor may pass entirely through the bone
and exit into the joint itself, here the acetabular socket A,
potentially damaging the cartilage and interfering with joint
motion. Thus, when repairing a torn labrum in an acetabular or
glenoid rim, the anchor has a diameter usually less than 5 mm,
preferably less than 4 mm, and more preferably 3.5 mm or less. The
length must be long enough to gain adequate purchase in the bone
while also being short enough to avoid penetration into the
articular surface, preferably being at least about 5 mm and less
than or equal to about 14 mm in length.
[0095] FIGS. 6A-6D illustrate an exemplary system and method for
reattaching a torn labrum to the acetabular rim. The suture anchor
system includes an outer anchor 62 and an inner anchor 66. A length
of suture 64 having a free end 68 is coupled to both of the anchors
62, 66. Preferably suture 64 is pre-threaded in both anchors 62, 66
such that no threading of the suture through the anchors is
required during the procedure, before or after placement of either
anchor. The pair of anchors 62, 66 include a coupling mechanism
63a, 63b that allow the two anchors to interlock with one another
when the inner anchor 66 is inserted into the outer anchor 62. In
this embodiment, the inner anchor 66 is inserted concentrically
into an inner cavity in the outer anchor 62, while in other
embodiments described below, the anchors may be coupled together
axially in a stacked relationship. In FIG. 6A, the torn labrum L is
shown separated from the acetabular rim R of a hip joint having an
acetabulum A. The outer anchor 62 is inserted into the acetabular
rim R in FIG. 6B, either by placing the anchor into a pre-drilled
hole or by directly driving the anchor into the bone. The suture 64
is then looped around the torn labrum L as shown in FIG. 6C and
then the inner anchor 66 is inserted into the outer anchor 62 where
the coupling mechanism 63a, 63b lock the two anchors together as
shown in FIG. 6D. The suture 68 may then be tightened by pulling
the free end which advances the suture through a cinching mechanism
(not illustrated) in either the inner or outer anchor to tension
the suture and draw the torn labrum into apposition with the
acetabular rim R. The cinching mechanism allows the suture to be
tensioned when pulled in one direction and constrains movement of
the suture in the opposite direction. Once the appropriate tension
has been achieved, the free end of the suture and any excess suture
may be severed and removed from the treatment site. Additional
details related to this method, the suture anchors and cinching
mechanism may be found in U.S. patent application Ser. No.
12/605,065 (Attorney Docket No. 028357-000120US, formerly
020979-003920) and U.S. patent application Ser. No. ______
(Attorney Docket No. 028357-000130US, formerly 020979-003910US),
the entire contents of which are incorporated herein by
reference.
[0096] Suture Anchor Configurations:
[0097] Any of the suture anchors described herein may be fabricated
from metals such as stainless steel, nitinol, titanium, etc.,
ceramics, and other biocompatible materials. However, in preferred
embodiments, the anchors are made from MRI (magnetic resonance
imaging) compatible polymers such as PEEK (polyetherether ketone)
or carbon reinforced PEEK. Dense, hard polymers are preferred so
that the anchors will be non-resilient and do not deform when
implanted. Preferred embodiments of anchors displace the bone or
other substrate tissue when implanted.
[0098] In other embodiments of suture systems, the anchor may
include more than one suture anchor positioned in a single hole.
For example, an approach for the deployment of suture anchors in an
axially stacked arrangement in the same hole is illustrated in FIG.
7. A pair of suture anchors 72, 74 and a length of suture 78 having
a free end 80 are used to reattach a torn labrum L to the
acetabular rim R. In this exemplary embodiment, both anchors 72, 74
are placed end-to-end in a single pre-drilled hole 76 or they may
be directly driven into the acetabular rim R. Suture 78 is coupled
to the distal-most anchor 72 with a knot 75 or using another
fastening method (e.g. crimping, bonding, etc.) and the length of
suture encircles the labrum L and passes through the proximal-most
anchor 74. The proximal-most anchor includes a cinching mechanism
(not shown) that allows the free end 80 of the suture 78 to be
pulled and tensioned in one direction while constraining movement
of the suture in the opposite direction. By placing the two anchors
end-to-end, both anchors may have maximum diameter within the
constraints of the target anatomical location which allows the
cinching mechanism size to also be maximized. Moreover, this
configuration also minimizes the number of holes that must be
drilled into the bone during the procedure. Another advantage of
this configuration is that a portion of the suture 78 is pinched
between an outer surface of the proximal-most anchor 74 and the
inner wall of the hole 76. Not only does this secure the suture in
position, but allows a gross adjustment of the suture length or
tension by pulling the end of the suture 78 to draw the repaired
tissue toward the bone, followed by a fine adjustment of suture
length and tension by pulling the opposite end of the suture
through the cinching mechanism. Additional details on cinching
mechanisms which may be used in these anchors are described below,
as well as in Provisional and Non-Provisional Patent Applications
previously incorporated herein by reference. The suture anchors may
also be placed in separate holes in the bone if desired.
[0099] Other exemplary configurations are shown in FIGS. 8-16. For
example, FIG. 8 schematically illustrates a two-part suture anchor
system having an anchor 5402 and an insert 5410 coupled together
with a suture S. The anchor 5402 generally has a cylindrical shaped
body 5406 and a pointed tip 5404 that is adapted to penetrate into
bone. A central channel 5408 is substantially parallel to the
longitudinal axis of the cylindrical body 5406. The insert 5410
also is generally cylindrically shaped and is concentrically
positionable in the central channel 5408 such that the distal end
5416 of the insert 5410 bottoms out in the central channel 5408.
The insert 5410 may be sized such that it is press fit into the
central channel 5408 or it may have a locking mechanism, such as a
detent mechanism, snap fit, threads, or other mechanical locking
mechanism to lock the insert 5410 with the anchor 5402. The insert
5410 also has a cinching mechanism 5412 that allows the suture to
be pulled in one direction for adjustment and tightening, while
constraining movement of the suture in the opposite direction. The
cinching mechanism may be any of the cinching mechanisms disclosed
herein. The suture S has one end attached to the anchor with a knot
5418 or by other techniques known to those skilled in the art and
the suture also passes through the cinching mechanism 5412 and a
free end 5414 extends from the insert. The free end 5414 may be
pulled to tighten the suture.
[0100] FIG. 9 schematically illustrates another anchor system
configuration similar to that of FIG. 8, with the major difference
being that the cinching mechanism is a part of the anchor instead
of the insert. In FIG. 9, the anchor 5502 generally has a
cylindrical shaped body 5506 and a pointed tip 5504 that can
penetrate into bone. The anchor 5502 also has a central channel
5508 and a cinching mechanism 5512. The cinching mechanism may take
the form of any of the cinching mechanisms described herein. The
insert 5510 is also generally cylindrically shaped and is
positionable in the central channel 5508 where it may be locked in
place using any of the features described herein. The distal end
5516 of the insert 5510 in this embodiment has a flat planar face,
although in other embodiments it may be pointed as will be seen
below. A suture S is coupled to both the anchor 5502 and the insert
5510. One end of the suture S is tied in a knot 5518 or otherwise
secured to the insert 5510 and the suture passes through the
cinching mechanism 5512 of the anchor 5502. A free end 5514 extends
from the anchor 5502 and may be pulled in one direction to tighten
the suture.
[0101] FIG. 10 schematically illustrates still another anchor
system having an anchor 5602, a suture S, and a needle insert 5610.
The anchor 5602 has a generally cylindrical shaped body 5606 with a
central channel 5608 and a pointed tip 5604 adapted to penetrate
into bone. A cinching mechanism 5612 that generally takes the form
of any of the cinching mechanisms disclosed herein is included in
the anchor 5602. The needle insert 5610 also has a cylindrically
shaped body and a distal tissue penetrating tip 5616 for passing
through tissue. A suture S is coupled to both the needle insert
5610 and the anchor 5602. One end of the suture S is fixed to the
needle insert 5610 with a knot 5618 or other technique and the
suture S passes through the cinching mechanism 5612. A free end
5614 extends from the cinching mechanism 5602 and may be pulled
through the cinching mechanism in one direction to tighten the
suture S. The cinching mechanism constrains movement of the suture
therethrough in the opposite direction.
[0102] FIG. 11 schematically illustrates yet another anchor system
having two anchors 5702, 5710. The first anchor 5702 has a
generally cylindrical shaped body 5706 and a pointed tip 5704 for
penetrating into bone. The second anchor 5710 similarly has a
cylindrically shaped body 5712 and a pointed tip 5714 for
penetrating into bone. The second anchor may be positioned in the
same or a different location than the first anchor. The second
anchor 5710 also includes a cinching mechanism 5716 that allows the
suture S to be advanced in one direction and constrained in the
opposite direction. A suture S is coupled to both anchors 5702,
5710. One end of the suture S is fixed to the first anchor 5702
with a knot 5708 or with other techniques known to those skilled in
art, and the suture S passes through the cinching mechanism 5716 in
the second anchor 5710. A free end 5718 of the suture S extends
from the cinching mechanism and may be pulled to adjust suture
length extending between the anchors 5702, 5710.
[0103] FIG. 12 illustrates another anchor system having two anchors
5802, 5812. In this embodiment, both anchors 5802, 5812 include
cinching mechanisms 5810, 5818. The first anchor 5802 has a
generally cylindrically shaped body 5806, a pointed distal tip 5804
for penetrating tissue such as bone and a cinching mechanism 5810.
The second anchor 5812 similarly has a cylindrically shaped body
5816, a pointed tip 5814 for penetrating bone or other tissue, and
a cinching mechanism 5818. The second anchor may be positioned in
the same location or a different location than the first anchor. A
length of suture S is coupled to both anchors 5802, 5812. The
suture passes through both cinching mechanisms 5810, 5818, and has
a first free end 5822 that extends from the first anchor 5802, and
a second free end 5820 that extends from the second anchor 5812.
Thus, in this exemplary embodiment, either or both free ends 5820,
5822 may be pulled in order to adjust the length of the suture
extending between the anchors.
[0104] FIG. 13 schematically illustrates another anchor system
having two anchors 5902, 5912. The first anchor 5902 includes a
generally cylindrically shaped housing 5906, a pointed distal tip
5904 for penetrating into bone and a central channel 5908. The
second anchor 5912 also includes a generally cylindrically shaped
body 5914, a pointed distal tip 5916 for penetrating bone, and a
cinching mechanism 5918. The second anchor 5912 may be positioned
directly into bone or it may be positioned concentrically in the
central channel 5908 of the first anchor 5902 and locked in place
using any of the locking mechanisms described herein or known in
the art. A length of suture S is coupled to both anchors 5902,
5912. One end of the suture S is fixed to the first anchor 5902
with a knot 5910 or by other methods known in the art. The suture S
passes through the cinching mechanism 5918 in the second anchor
5912 and a free end 5920 extends from the second anchor 5912 and
may be pulled in one direction to adjust the suture length between
the two anchors. The cinching mechanism prevents the suture from
moving in the opposite direction.
[0105] FIG. 14 schematically illustrates another anchor system
having two stacked anchors 6002, 6012. The first anchor 6002 has a
generally cylindrically shaped body 6006, a pointed tip 6004 for
penetrating bone and a central channel 6010 that is generally
parallel with the longitudinal axis of the first anchor 6002. The
second anchor 6012 also includes a generally cylindrically shaped
body 6014 and a cinching mechanism 6018. The cylindrical body 6014
has a tapered shoulder 6022 near the distal end of the anchor 6012
and a reduced diameter distal region 6016 that is positionable and
lockable in the central channel 6010 of anchor 6002. A suture S is
coupled to both anchors 6002, 6012. One end of the suture S is
fixed to the first anchor 6002 with a knot 6008 or by other
techniques. The suture passes through the cinching mechanism 6018
and a free end 6020 extends therefrom.
[0106] FIG. 15 schematically illustrates another anchor system
having an anchor 6102 and a needle insert 6112. The anchor 6102
generally takes the same form as other anchors disclosed herein and
includes a cylindrically shaped body 6106, a pointed distal tip
6104 for penetrating tissue such as bone, and a central channel
6110 that is substantially parallel to the longitudinal axis of the
anchor 6102. The needle insert 6112 includes a cylindrically shaped
body 6114, a cinching mechanism 6118, and a pointed distal tip 6116
that can penetrate tissue or bone. The needle insert 6112 is
positionable and lockable in the central channel of the anchor
6102. A suture S is coupled to both the anchor 6102 and the needle
insert 6112. One end of the suture S is attached to the anchor 6102
with a knot 6108 or by other attachment means known in the art. The
suture also passes through the cinching mechanism 6118 and a free
end 6120 of the suture S extends from the needle insert 6112 and
may be pulled through the cinching mechanism to tighten the suture,
while movement of the suture in the opposite direction is
constrained. In this exemplary embodiment, the cinching mechanism
may take the form of any of the embodiment disclosed herein.
[0107] FIG. 16 schematically illustrates still another anchor
system, this time with a single anchor 6202. The anchor 6202
includes a generally cylindrically shaped body 6206, a cinching
mechanism 6208, and a pointed distal tip 6204 for penetrating
tissue such as bone. One end of a suture S is fixed to the anchor
6202 with a knot 6212 or by other means and forms a loop region
6214 before passing through the cinching mechanism 6208. A free end
6210 of the suture S extends from the anchor 6202 and may be pulled
to adjust the suture. In use, the suture at least partially
encircles tissue to be captured and then the anchor 6202 passes
through the loop 6214 and is then anchored into bone or other
tissue. The suture can then be adjusted by pulling the free end
6210.
[0108] FIGS. 17A-17D illustrate another embodiment of a suture
anchor system having an anchor and a needle. FIGS. 17A-17B are
perspective views of the system rotated into different positions.
FIG. 17C is a perspective view of the system when the anchor is
coupled to the needle and FIG. 17D is a cross-sectional view of
FIG. 17C taken along its longitudinal axis. The anchor system
includes an anchor 6502 having a cylindrical shaped body 6504 and a
plurality of barbs or scallops 6506 along the outer surface of the
body 6504 to help the anchor remain positioned in tissue such as
bone. The distal portion 6510 of the anchor has a flat end and a
plurality of longitudinal slits 6508 that allow the distal portion
6510 to expand and contract as the needle is inserted into the
anchor. The proximal end 6520 of the anchor 6502 is also flat and
has a central channel 6526 extending all the way through the anchor
6502. The channel 6526 is substantially parallel to the
longitudinal axis of the anchor. A channel 6524 extends through a
side wall of the anchor substantially parallel to the longitudinal
axis of the anchor and intersects with a passage 6522 that extends
transversely through the anchor side wall (best seen in FIG. 17B).
A suture may be fed through these passages and tied to the
anchor.
[0109] The needle 6512 includes a pointed tip 6514 that is adapted
to pierce tissue and also has a shoulder 6518 that helps the needle
snap into engagement with the anchor when the needle is
concentrically positioned in the anchor. The needle 6512 also
includes a cylindrical body 6512a and the proximal end 6528 of the
needle 6512 is flat and has a central channel 6530 extending into
the needle. A central region of the needle includes a cinching
mechanism 6516 which includes two apertures 6516a, 6516b (best seen
in FIG. 17D) for receiving suture (not illustrated). This
embodiment of cinching mechanism generally operates in the same
manner as described with respect to FIGS. 21A-21B described below.
One of skill in the art will of course appreciate that any of the
cinching mechanisms disclosed herein may also be used.
[0110] In use, the anchor 6502 is positioned in bone and the needle
is used to pierce through and pass a suture through damaged tissue.
The needle is then coupled with the anchor and the suture is
tensioned by pulling it through the cinching mechanism. This will
be more thoroughly described below.
[0111] In some embodiments, a portion of the anchoring system
includes a piercing needle for capturing the damaged tissue by
passing the suture therethrough. FIG. 18 illustrates another
embodiment of an anchor system and needle. The anchor 6602 has a
generally cylindrical shaped body 6604 with barbs 6608 along the
outer surface and a tissue piercing tip 6606. The anchor 6602
includes any of the cinching mechanisms described herein and has a
central passage 6616 for receiving the tissue piercing needle 6610.
A length of suture S having a free end 6612 is fixed to the needle
6614 by crimping, bonding, knotting or by other methods. The suture
passes into the cinching mechanism (not illustrated) in the anchor
6602 and the free end 6612 exits the anchor. In use, the anchor
6602 is positioned in bone and the suture S at least partially
captures the tissue to be repaired. The needle 6610 is then pierced
through the tissue and the suture is also passed through the
tissue. The needle is then inserted concentrically into the central
channel 6616 of the anchor 6602 and locked into position. The
suture S is then adjusted by pulling on the free end 6612 of the
suture. In preferred embodiments, the needle diameter ranges from
about 1.0 mm to about 2.2 mm. Needle length may range from about 2
mm to about 13 mm. The needle may have a straight tip or the tip
may be curved or angled. An angled needle may range from 20 to 60
degrees. Using a needle to pass through the tissue may help retain
the natural shape of the tissue thereby helping it to reattach and
heal more quickly than if the tissue were deformed by tightening
the suture around the tissue.
[0112] In anchoring systems having two or more suture anchors, it
may be advantageous to attach the two anchors directly together.
This minimizes the possibility that the anchors will become
dislodged. For example, in FIG. 19, two anchors are stacked
together in the same hole and joined with one another. A pair of
anchors 82, 84 are coupled together with a suture 86 having a free
end 86a. A coupling element 83 extends from the proximal end of the
distal anchor 82 and allows the two anchors to be joined together.
One end of the suture 86 is fixed to one anchor 82 with a knot 88
or other fastening methods may be used, and this anchor 82 may be
placed into the bone before the other anchor 84. Once the anchor 82
is positioned into a pre-drilled hole in the bone or driven
directly into the bone, the target tissue is captured by wrapping
the second anchor around it or placing the second anchor through a
penetration through the target tissue. Second anchor 84 is
preferably placed into the same hole as first anchor 82, but may be
configured for placement in a separate hole if desired. The second
anchor 84 is advanced in the hole until its distal end butts up
against the proximal end of the first anchor 82 and the coupling
element 83 joins the two anchors together. The coupling element 83
may be a threaded rod that allows the two anchors to be screwed
together, or the coupling element 83 may be a compression coupling
with ribs or other features to enhance friction that is press fit
into a corresponding bore (not shown) in the second anchor 84.
Coupling element 83 has a relief feature 83a which allows two
opposing halves of the relief feature to flex radially inward
toward each other to facilitate insertion in the bore in the distal
end of proximal anchor 84. One of skill in the art will appreciate
that other coupling mechanisms, such as a ratchet, detent, snap fit
or other mechanisms may be used to join the two anchors together.
Once the two anchors are coupled together, the free end 86a of the
suture may be pulled to advance the suture 86 through a cinching
mechanism (not shown) in the second anchor 84 thereby allowing
adjustment of suture length and tension. The second anchor 84 may
have any of the cinching mechanisms disclosed in this
specification.
[0113] FIG. 20 illustrates another exemplary embodiment of a pair
of anchors that couple together in an end-to-end configuration. The
anchors 1002, 1004 are coupled together with a length of suture
1018 having a free end 1018a. Each anchor 1002, 1004 has a tapered
distal end 1006, 1008 that helps align the anchor into a hole
drilled into the bone or provides a penetrating tip that may be
driven directly into bone. A coupling element 1010 is attached to
anchor 1002 and may be a threaded rod or a compression coupling
that engages with the corresponding engagement feature (e.g. a
threaded female receptacle or a channel) 1012 on anchor 1004.
Additionally, anchor 1004 includes a series of relief slots 1014
that allow the distal extremity of the anchor to radially expand
and contract as the coupling element 1010 is advanced into
engagement with anchor 1004. Thus, as the coupling element is
initially advanced into aperture 1012, the relief slots allow the
anchor 1004 to expand and receive the coupling element 1010. Once
the coupling element has been inserted into anchor 1004, the anchor
collapses back to its natural shape, locking the coupling element
1010 in place and providing an end-to-end or stacked pair of suture
anchors. While this embodiment illustrates the male coupling
element 1010 on anchor 1004, one will of course appreciate that it
could easily be placed on anchor 1004. In use, once the anchors
have been placed into the bone, the free end of the suture 1018a
may be pulled, pulling the suture 1018 through a cinching mechanism
(not shown) in anchor 1004. The cinching mechanism may be any of
the mechanisms disclosed in this specification or incorporated by
reference.
[0114] One-Way Cinching Mechanisms:
[0115] FIGS. 21A-21B illustrate a first exemplary embodiment of a
suture cinching mechanism that may be used in any of the suture
anchors disclosed herein. The suture anchor 1202 may have a tapered
cylindrical tip 1204 to facilitate positioning in a hole in bone or
to provide a tip that may be advanced to penetrate directly into
the bone. A central wall 1216 extends proximally from tip 1204 such
that its face 1218 is generally parallel to the longitudinal axis
1222 of anchor 1202. Wall 1216 has an upper aperture 1208 and a
lower aperture 1210 extending transversely (indicated by phantom
line 1224) through wall 1216 and separated by a bar 1220, thus
forming a buckle 1206. A first extremity 1214 of suture S enters
the lower aperture 1210 from one side of the buckle, passes through
the lower aperture 1210 and exits the aperture. The suture S then
enters the upper aperture 1208 from the opposite side of the buckle
and exits the aperture such that a second extremity 1212 of the
suture S is positioned under the first extremity 1214 of the
suture, thus forming a loop around bar 1220. It will be appreciated
that the terms "enter" and "exit" are relative and therefore a
suture that enters an aperture may also be referred to as exiting
the aperture. Similarly, a suture that is described as exiting an
aperture may be referred to as entering the aperture. This applies
throughout this specification unless indicated to the contrary.
When positioned in a hole in bone or other tissue, anchor 1202 is
inserted far enough so that wall 1216 is fully recessed inside the
hole. This constrains the first extremity 1214 and second extremity
1212 of suture S within a space lying between the wall 1216 and the
surrounding bone or tissue, thereby maintaining them in an
orientation in which the first and second extremities are generally
parallel (+/-30 degrees) to the longitudinal axis 1222 of anchor
1202 and the face 1218 of wall 1216. This orientation of the first
and second extremities of suture S help to ensure the proper
functioning of the cinching mechanism. If the second extremity 1212
of suture S is pulled the suture will advance through the buckle.
However, when the first extremity 1214 of the suture is pulled, it
compresses second extremity 1212 against the underlying face 1218
of wall 1216, thereby preventing the suture from advancing through
the buckle. Preferably, the lower aperture 1210 forms a corner 1226
where it intersects with the face of bar 1220, the corner having an
angle of no more than about 90 degrees, thus creating an edge which
engages suture S and inhibits its movement when first extremity
1214 is tensioned. Thus, the cinching mechanism allows the suture
be adjusted in one direction and constrains motion in the opposite
direction. In this embodiment, the suture is preferably a suture
having a flat or rectangular cross-section in order to increase
friction, but other cross-sections may also be used including round
suture. The slots 1208, 1210 are sized and shaped accordingly,
therefore in this embodiment, both slots are rectangular, but they
could also be round. FIG. 21B is a side view of FIG. 21A.
Preferably this suture anchor and others described herein are
fabricated by injection molding a polymer such as
polyetheretherketone (PEEK), carbon reinforced PEEK or other
polymers including biodegradable polymers such as polylactic acid
(PLA) or polyglycolic acid (PGA). Thus, a single integral construct
is provided requiring no assembly and no moving parts.
Alternatively, some embodiments of anchors disclosed below may be
moldable as a single piece, but may be molded into several
components which are then assembled together.
[0116] Although not illustrated, it will be understood that any of
the embodiments of the suture anchors of the invention described
herein may include features on the exterior thereof to enhance
retention of the anchor in bone or other tissue. Such features may
comprise bumps, ridges, ribs, threads, scales, flaring wings,
projections, or other structures to enhance friction or to
mechanically engage the surrounding bone or tissue and resist
proximal movement of the anchor after it has been fully inserted.
Such features are well-known in the art, with examples illustrated
in U.S. Pat. Nos. 6,554,852, 6,986,781, and 6,007,566, which are
incorporated herein by reference.
[0117] FIGS. 22A-22B illustrate another cinching mechanism
embodiment. This is similar to the one previously described in
FIGS. 21A-21B with the major difference being that the cinching
mechanism is enveloped by a housing. FIG. 22A shows a cross-section
of the anchor and cinching mechanism. The anchor 1302 has a tapered
tip 1312 for alignment with a hole in bone or for providing a tip
that can penetrate directly into bone. The anchor has a central
wall 1322 arranged generally parallel to the longitudinal axis of
the anchor with two transverse apertures 1308, 1310 therein
separated by a transverse bar 1324, forming a buckle 1306 for
cinching the suture S. The cinching mechanism is surrounded by a
housing 1304 having two proximal openings 1314, 1316. The housing
is preferably cylindrically shaped, but may have other
configurations, including, but not limited to square, rectangular,
oval, triangular, or other shapes. Any of the anchor housings
disclosed herein may have any of these shapes. The housing guides
the first extremity 1318 and second extremity 1320 from apertures
1314, 1316 in a direction generally parallel to wall 1322 in lieu
of relying upon the wall of the hole for this purpose as in the
previous embodiment. A first extremity 1318 of suture S enters the
lower aperture 1310 from a first side and exits that aperture on a
second side, opposite the first side. The suture then enters the
upper aperture 1308 from the second side and exits the upper
aperture on the first side. A second extremity 1320 of the suture S
exiting the upper aperture 1308 is positioned under the first
extremity 1318 of suture S. In this embodiment, the suture S enters
and exits the housing through aperture 1314, although the suture
could also enter and exit the other aperture 1316. Operation of the
cinching mechanism is generally the same as previously described
with respect to FIGS. 21A-21B. Pulling on the second extremity of
suture 1320 allows the suture to pass through the buckle 1306.
However, pulling on the first extremity of suture 1318 compresses
the second extremity of suture 1320 against the wall 1322 creating
friction between the suture and the buckle 1306, thereby preventing
the suture from moving in that direction. Optionally, ridges,
bumps, or other features may be provided on the face 1326 of wall
1322 to enhance friction against second extremity of suture 1320.
This embodiment may be molded as a single integral construct or as
two or more components that are assembled together. For example,
the buckle and anchor tip may be molded as one component and the
cylindrical housing may be molded as a second component. The two
pieces may then be bonded, welded, fastened or snap fit together
using techniques well known in the art.
[0118] FIG. 23 illustrates a perspective view of a suture anchor
system having an outer anchor, an inner anchor positionable
concentrically in the outer anchor, and a cinching mechanism in the
inner anchor. The outer anchor 4202 includes a cylindrical shaped
housing 4208 with a central channel 4210 and a pointed or tapered
tip 4204 similar to those previously described. The housing
includes a plurality of longitudinally oriented slots 4206 that
form discrete sections at the proximal end of the housing which can
flex outwardly. Additionally, the housing includes an outer annular
flange 4216 and an inner annular flange 4220. The inner anchor 4212
has a distal pointed or tapered distal tip 4214 that may be used to
help guide the inner anchor into the outer anchor or that may be
driven directly into the bone or other tissue. The proximal end of
the inner anchor has an annular flange 4218 and also a cylindrical
end with a passage 4226 therethrough. A middle portion of the inner
anchor between the distal tip and the proximal end includes a flat
recessed section 4228 having passages 4222, 4224 therethrough and
an opening 4230 which communicates with passage 4226. In an
exemplary embodiment the distal end of inner anchor 4212 has a
sharpened tip adapted to penetrate the damaged tissue that is to be
reattached, such that the inner anchor functions as a needle to
pass directly through such tissue without the need for a separate
device to create a penetration. In use, a first end of a suture
(not shown) may be fixed to the outer anchor 4202 and the suture
may then be threaded through apertures 4222, 4224 to form the
cinching mechanism as shown in the embodiments illustrated in FIGS.
21A-21B or 22A-22B. Once the outer anchor is positioned into bone
or other tissue, the suture may be looped around damaged tissue or
passed through a penetration in the damaged tissue and then either
be inserted into the outer anchor and locked in place or positioned
into the bone or other tissue separate from the outer anchor. Outer
flanges 4216, 4218 on the outer and inner anchors are used as a
seat for engagement by a delivery instrument to facilitate
insertion of the anchors into the bone. Additionally, when the
inner anchor is inserted into the outer anchor, the slots 4206
allow the discrete sections of the housing to be deflected
outwardly to receive the inner anchor then resiliently snap back
inwardly to lock the inner anchor in place. Once the inner anchor
has been advanced deep enough into the outer anchor, the flange
4218 on the inner anchor will engage the flange 4220 on the outer
anchor and the two anchors will be locked together. The suture may
then be adjusted by pulling it through the cinching mechanism as
previously described with respect to FIGS. 21A-21B and 22A-22B. In
preferred embodiments, the outer diameter of the outer anchor is
less than 4 mm and no more than 3.5 mm and the overall length of
the inner and outer anchors when coupled together is less than 15
mm, and more preferably less than 12 mm. The inner and outer
anchors are preferably each a single piece molded construct,
preferably being molded from a polymer such as PEEK or carbon-fiber
filled PEEK. One of skill in the art will appreciate that any of
the other cinching mechanisms described herein my easily be
substituted for the cinching mechanism shown in FIG. 23.
[0119] FIG. 24A illustrates a perspective view of another exemplary
embodiment of a suture anchor having two stacked anchors and a
cinching or locking mechanism for the suture. FIG. 24B is a
cross-sectional view of the anchor in FIG. 24A taken along line A-A
(along the longitudinal axis and after the anchor has been rotated
approximately 90 degrees). The anchor system includes a top anchor
4302 and a bottom anchor 4316. The bottom anchor generally consists
of several cylindrical sections of varying diameters. The conical
distal end 4304 of the bottom anchor 4316 is tapered or pointed to
facilitate driving the anchor directly into bone or other tissue or
to help center the bottom anchor into an existing pre-drilled hole.
A channel 4306 passes transversely through the bottom anchor and
may be used to fix a suture thereto. As shown in FIG. 24B, the
channel 4306 has a smaller diameter section large enough to
accommodate the diameter of the suture, and a larger diameter
section which allows a knot to be tied in the suture, the knot
being too large to pass through the smaller diameter section,
thereby securing the suture in the channel. A proximal portion of
the bottom anchor 4316 has a central cavity adapted to receive and
couple with the distal tip of the top anchor 4302. Both the top
anchor 4302 and bottom anchor 4316 have a plurality of
circumferential ribs 4308 disposed on their exterior to help hold
the anchors in bone or tissue. Ribs 4308 each have an angled bevel
on their distal edges to allow the anchor to pass more easily into
bone or tissue, while having a flat proximal aspect that engages
the tissue or bone into which the anchor is disposed to resist
migration of the anchor proximally. The top and bottom anchors are
preferably of the same diameter so as to fit snugly in the same
pre-drilled hole. The distal tip of the top anchor 4302 is received
in the cavity in the proximal portion of the bottom anchor 4316 and
preferably includes some means of coupling the two anchors
together, such as a friction fit between the interconnecting parts,
or a coupling mechanism similar to that described in other
embodiments disclosed herein. The proximal end of the upper anchor
4302 includes a central channel 4314 that allows the suture to pass
through into a recessed central portion of the anchor which
includes a flattened region having apertures 4310, 4312
therethrough. The suture may be threaded through apertures 4310,
4312 as described in the embodiments of FIGS. 21A-21B and FIGS.
22A-22B. In use, with the suture pre-attached to bottom anchor 4316
and pre-threaded through apertures 4310, 4312, the bottom anchor
4316 is driven directly into bone or inserted in a pre-drilled
hole, and the top anchor 4302 is then looped around or passed
directly through a penetration in the tissue to be repaired. Top
anchor 4302 is then inserted into the same hole in which bottom
anchor 4316 is positioned until its distal tip seats within the
proximal end of the bottom anchor. The suture may then be adjusted
or locked as described above. It will be understood that the top
anchor 4302 may have a sharpened distal tip to allow it to
penetrate directly through the tissue to be repaired without need
for a separate instrument to create a penetration.
[0120] FIGS. 25A-25B illustrate yet another exemplary embodiment of
a suture anchor with cinching mechanism. FIG. 25A is a
cross-sectional view of FIG. 25B. The suture anchor 1402 has a
tapered or pointed tip 1404 to help align it with a hole in the
bone or to provide a tip that may be driven directly into bone. A
cylindrical housing 1406 surrounds the cinching mechanism which
includes two central walls 1408, 1412 that are offset from one
another in a direction transverse to the longitudinal axis of the
anchor 1402. The lower central wall 1408 has a lower aperture 1410
passing therethrough and an upper aperture 1414 is created by the
space between the two offset walls 1408, 1412, forming a bar 1422
between the apertures. The top of the anchor is sealed except for
an opening 1420 that is sized to allow the suture S to enter and
exit the anchor. A first extremity 1418 of suture S enters the
anchor through opening 1420 and travels down a first side of
central wall 1412. The suture then crosses the central wall to the
opposite, second side of the wall 1412 by passing through a gap
created by the offset between the upper 1412 and lower 1408 walls.
The suture S then travels down the second side and enters an
aperture 1410 in the lower wall 1408. A second extremity 1416 of
suture S exits the aperture 1410 on the first side and travels up
the anchor and out of opening 1420. Opening 1420 helps orient the
first and second extremities of suture 1416, 1418 so they are
generally parallel with the face of upper wall 1412 as they enter
and exit the anchor. In use, when the first extremity 1418 of
suture S is pulled, the suture will advance through the cinching
mechanism and thus the suture S length and tension may be adjusted.
However, when the second extremity 1416 of suture S is pulled,
first extremity 1418 is compressed against the upper wall 1412 and
in particular the lower corner 1424 of upper wall 1412, creating
friction against the suture and preventing movement of the suture
in that direction. Aligning the suture extremities to be parallel
with one another and with upper wall 1412, helps maximize friction
between the suture extremities and the central wall. Thus, the
suture may be adjusted in one direction only.
[0121] A further embodiment of a suture anchor according to the
invention is illustrated in FIGS. 26A-26B. FIG. 26A illustrates a
cross-section of the suture anchor and FIG. 26B illustrates another
cross-section of the anchor rotated approximately 90 degrees. The
suture anchor 1502 includes a tapered tip 1504 that generally takes
the same form as those previously described above. A cylindrical
housing 1518 having a central channel 1516 surrounds the cinching
mechanism which comprises a barrel insert 1508 disposed in a
transverse bore 1506 in the housing 1518. The barrel insert 1508 is
transverse to the longitudinal axis of the anchor and preferably is
orthogonal to the longitudinal axis. FIG. 26C illustrates the
barrel insert 1508 removed from the anchor. The barrel 1508 has an
upper aperture 1512 and a lower aperture 1514, both sized to accept
suture, which are configured and operate in a manner similar to
those described above in connection with FIGS. 21A-21B, and
22A-22B. An opening 1510 in the top of the housing 1518 allows the
suture to enter and exit the suture anchor. This construction
allows the cinching mechanism (barrel 1508) to be molded as a
separate part from the remainder of the anchor, and the two parts
are assembled by press fitting, bonding, or otherwise fixing barrel
1508 within bore 1506.
[0122] The previous embodiments have no moving parts and thus the
suture may be adjusted and locked without actuating or moving any
components. The size, shape, position, and orientation of all parts
of the anchor remain the same whether the suture is being adjusted
or locked. Other embodiments, such as those shown in FIGS. 27A-27F,
include a cinching mechanism with at least one moving part. FIGS.
27A-27F illustrate a suture anchor similar to that shown in FIGS.
26A-26C, but in this embodiment the barrel 1508 is rotatable about
a transverse axis from an unlocked position, shown in FIGS.
27A-27B, and 27F, to a locked position shown in FIGS. 27C-27D, and
27E. FIGS. 27A and 27B are cross-sections of the anchor taken at
positions approximately 90 degrees apart from one another. In FIG.
27A, the suture S has a first extremity 1520 which extends downward
through aperture 1510 and enters aperture 1512 in the rotatable
barrel 1508 from a first side. The suture exits aperture 1512 on a
second side opposite the first, crosses under the barrel and enters
aperture 1514 from the second side, passes through aperture 1514
and a second extremity 1522 of the suture S exits the barrel on the
first side. In the unlocked position, the barrel is positioned in
the anchor such that both apertures 1512, 1514 are generally facing
upwards in a direction parallel to the longitudinal axis of the
anchor. A pin 1524 in barrel 1508 is movable within a curved
channel in the wall of housing 1518 and prevents the barrel from
rotating beyond certain limits. Thus, when a first extremity 1520
of the suture is pulled the barrel rotates into the unlocked
position and is prevented from further rotation by engagement of
the pin with the housing 1518. With the barrel 1508 in the unlocked
position, friction against the suture is minimized and suture
length and tension may be easily adjusted. However, when the second
extremity 1522 of the suture S is pulled in a second direction
opposite the first direction, the barrel will rotate into the
locked position, preventing suture movement in that direction.
[0123] FIGS. 27C-27D illustrate the suture anchor of FIGS. 26A-26C
with the barrel rotated into the locked position. FIGS. 27C and 27D
are cross-sections of the anchor taken at positions approximately
90 degrees apart from one another. When the suture is pulled in the
second direction, the barrel 1508 rotates and locks the suture. In
the locked position, apertures 1512, 1514 are oriented to face
transverse to the longitudinal axis of the anchor 1502, with both
the first and second extremities 1520, 1522 of the suture extending
from the apertures in a direction generally parallel to the lateral
face of barrel 1508. Locking occurs because the first extremity
1520 is sandwiched between the second extremity 1522 and barrel
1508 such that, when second extremity 1522 is tensioned, the first
extremity 1520 is compressed against the wall of barrel 1508 by the
second extremity 1522.
[0124] FIGS. 28A-28C illustrate another exemplary embodiment of a
suture anchor having a cinching mechanism for adjusting the suture
length and tension. This embodiment relies on the suture S crossing
itself to create friction and compression on the suture that
prevents movement of the suture in one direction while allowing
movement in the opposite direction. FIG. 28A is a cross-section of
the suture anchor 1602 which has a tapered or pointed tip 1604 that
generally takes the same form as previously described suture anchor
tips. A cylindrical housing 1606 encloses the cinching mechanism
which includes two guide members 1614 and 1616 transversely
positioned in the suture anchor housing relative to the
longitudinal axis of the suture anchor. Guide members 1614, 1616
are separated by a gap therebetween. An upper opening 1608 allows
the suture S to enter and exit the suture anchor. Guide members
1614, 1616 preferably have enlarged middle portions 1624, 1626
which extend toward each other, and may optionally engage or be
integrally attached to each other. The undersides of middle
portions 1624, 1626 comprise angled surfaces that merge toward one
another, creating a notch N. A first extremity of suture 1622
enters the suture anchor through opening 1608 and partially
encircles the first guide member 1616 and the second guide member
1614. After the suture is looped over the top of guide member 1614,
it bends downward between the two guide members and forms a loop
1618 around an intermediate segment of suture 1628 extending across
notch N. The suture then extends upward between the two guide
members and a second extremity 1620 of the suture S exits the
suture anchor through opening 1608. FIG. 28B illustrates a
cross-section of anchor 1602 taken along line A-A in FIG. 28A.
[0125] FIG. 28C illustrates the path of the suture S around the
guides in greater detail. In use, the first extremity of suture may
be pulled in the direction indicated by arrow 1612 thereby allowing
the suture length and tension to be adjusted. In this direction,
the suture may pass freely around the guide members without
binding. However, when the second extremity of suture 1620 is
pulled in the direction indicated by arrow 1610, the loop 1618
tightens around the intermediate segment 1628, drawing it into
notch N. Intermediate segment 1628 is thus compressed against the
middle portions 1624, 1626 of guide members 1614, 1616, thereby
locking the suture in position.
[0126] FIGS. 29A-29C illustrate yet another embodiment of a
cinching mechanism in a suture anchor. FIG. 29A is a cross-section
of a suture anchor 1702 having a tapered tip 1704 that generally
takes the same form as tips previously describe above. The suture
anchor has a cylindrical housing 1706 that surrounds the cinching
mechanism. A plurality of openings 1708, 1710, 1712 and 1714 on the
top surface of the housing allow the suture to enter and exit the
anchor. A first extremity 1720 of suture S enters aperture 1708 and
extends into a central channel 1724 of the anchor. The cinching
mechanism includes a partition 1716 having a notched end 1718 in
the central channel 1724. The first extremity 1720 of the suture S
extends down into the central channel 1724 and has an intermediate
segment 1728 that extends underneath the partition 1716
transversely across notch 1718. Suture S then extends upward and
exits the anchor from aperture 1710. The suture crosses over a top
of the anchor and re-enters the anchor in aperture 1712, extends
down into the central channel and forms a loop 1722 across the
intermediate segment 1728 of suture in a direction parallel to
notch 1718. A second extremity 1726 of the suture extends upward
from loop 1722 and exits the suture anchor through a fourth
aperture 1714 in the top of the anchor. FIG. 29B is a top view of
the anchor and FIG. 29C is a cross-section of FIG. 29A taken along
line A-A.
[0127] In operation, the first extremity of suture 1720 may be
pulled in a first direction and the suture is advanced through the
cinching mechanism thereby adjusting length or tension in the
suture. However, when the second extremity 1726 is pulled in a
second direction opposite the first direction, intermediate segment
1728 is drawn upward by loop 1722 into notch 1718, compressing it
against partition 1716 and binding the suture to prevent its
movement in the second direction.
[0128] FIG. 30A illustrates a cut-away view of still another
exemplary embodiment of a suture anchor having a cinching mechanism
and FIG. 30B illustrates a cross-section of FIG. 30A taken along
line A-A. The suture anchor 1802 has a tapered or pointed tip 1804
that generally takes the same form as other anchor tips previously
described above. A cylindrical housing 1806 surrounds the cinching
mechanism which includes a cylindrical central post 1808 disposed
in the anchor and having an aperture 1810 extending therethrough.
Openings 1814 and 1816 allow the suture S to enter and exit the
anchor. In this embodiment, a first extremity 1820 of the suture S
enters the anchor through opening 1814, travels down into the
anchor and enters passage 1810 in the central post 1808 from a
first side. The suture S then exits passage 1810 on a second side
opposite the first side and then partially loops around the central
post, crossing over itself to form a loop 1812 around the first
extremity 1820 of suture S. A second extremity 1818 then travels up
and out the anchor via opening 1816. When the first extremity 1820
of suture S is pulled in a first direction, the suture S is easily
advanced through the cinching mechanism allowing the suture tension
and length to be adjusted. However, when the second extremity 1818
is pulled in a second direction opposite the first direction, loop
1812 tightens and compresses first extremity 1820 against post
1808, resulting in friction between the suture and the central post
1808. This prevents the suture from being pulled in the second
direction. Optionally, features such a bumps or ridges or coatings
to enhance friction may be provided on the surface of post 1808 to
enhance the resistive forces on suture S.
[0129] FIG. 31A illustrates another exemplary embodiment of a
suture anchor where the suture crosses over itself. FIG. 31B
illustrates a cross-section of FIG. 31A taken along line A-A. The
suture anchor 1902 includes a pointed or tapered tip 1904 similar
to other tips described above and the anchor also has a cylindrical
housing 1906 similar to those described above. One of skill in the
art will appreciate that while many of the embodiments described
herein have a cylindrically shaped housing, other shapes may also
be used in this or any of the embodiments disclosed herein,
including, but not limited to square, rectangular, oval,
triangular, or other symmetric and non-symmetrical configurations.
The top of the housing has two apertures 1908, 1910 that allow the
suture S to enter and exit the anchor. A single aperture
accommodating both extremities of the suture is also possible. In
this embodiment, the cinching mechanism includes a central bar 1912
that is disposed in the anchor transverse to the longitudinal axis
of the anchor, preferably orthogonal. The central bar 1912 includes
two passages 1914, 1916. In operation, a first extremity 1922 of
the suture S enters aperture 1910 and travels downward into the
anchor and enters passage 1914 from the top. The suture then exits
passage 1914, and has an intermediate segment 1924 disposed
substantially parallel along the underside of central bar 1912.
Suture S then passes through passage 1916, loops around the central
bar 1912 and forms a loop 1918 over the intermediate segment 1924.
A second extremity 1920 of the suture S then runs upward and out of
the anchor through aperture 1908. The suture anchor operates
similarly to other embodiments described above where the suture
crosses over itself. In this embodiment, the suture may be advanced
when the first extremity 1922 is pulled in a first direction since
the suture does not bind against itself or the central bar.
However, when the second extremity 1920 of suture S is pulled in a
second direction opposite the first direction, loop 1918 tightens
up around intermediate segment 1924, compressing it against bar
1912 to create friction between the suture and the central bar
which prevents the suture from moving. Again, bar 1912 may be
provided with friction-enhancing features or a coatings to enhance
the resistive force on suture S.
[0130] FIG. 32A illustrates another exemplary embodiment of a
suture anchor where the suture crosses over itself. FIG. 32B is a
cross-section of FIG. 32A taken along line A-A, and FIG. 32C
highlights a portion of the cinching mechanism in greater detail.
The suture anchor 2002 includes a tapered or pointed tip 2004
similar to other anchor tips described previously and the anchor
has a cylindrical housing 2006 with apertures 2012, 2014, and 2016
in a sidewall of the housing. Aperture 2022 is in a top surface of
the housing. The cinching mechanism includes a cradle 2008 having
eyelets 2010a, 2010b and a V-notched channel 2026 for holding the
suture S. The V-notch is transverse to the longitudinal axis of the
cradle. Cradle 2008 may be integrally formed with housing 2006 or
may be a separate component attached to the inside wall of the
anchor housing 2006 using methods well known in the art (e.g.
welding, screws, bonding, snap fitting, etc.). A first extremity
2024 of the suture S enters the anchor and extends through eyelets
2010a, 2010b across the cradle 2008, with an intermediate portion
2030 of suture S being substantially parallel to the longitudinal
axis of the cradle and transverse to V-notched channel 2026. The
suture then exits a lower portion of the anchor via a side aperture
2016. The suture 2028 then wraps partially around an external
surface of the housing and re-enters the anchor via another side
aperture 2012, The suture S then crosses over intermediate segment
2030 in a direction substantially parallel to V notched channel
2026 and exits the anchor via aperture 2014, forming a loop 2018. A
second extremity 2020 then extends upward away from the anchor. The
first extremity of suture 2024 may be pulled in a first direction
thereby adjusting suture tension or length, however, when the
second extremity 2020 of the suture is pulled in a second direction
opposite the first direction, the loop 2018 tightens down upon
intermediate segment 2030, pulling it into V-notched channel 2026
to create friction between the suture and the cradle, thereby
preventing the suture from moving in the second direction.
Preferably, channels or recesses (not shown) are provided in the
outer wall of the anchor to receive those portions of the suture
running along the exterior of the anchor to allow the suture to
slide easily even when the anchor is placed in bone.
[0131] FIG. 33 illustrates another embodiment of a suture anchor
with a cinching mechanism. The suture anchor 2102 includes a
pointed or tapered tip 2104 similar to those previously described
and has a cylindrical housing 2106 containing the cinching
mechanism. An aperture 2108 on the top surface of the housing
allows the suture S to enter and exit the anchor. A central channel
2114 directs the suture toward a sliding wedge 2112 which is
captured in a channel 2110 of the anchor. The sliding wedge may
have any number of shapes, but in this embodiment includes an
angled upper surface 2112a that corresponds to the angled upper
surface 2110a of the channel 2110 in which the wedge slides.
Preferably the angled upper surface 2110a forms an angle with the
longitudinal wall 2120 of central channel 2114 which is less than
90 degrees, more preferably less than about 80 degrees, to increase
the friction on the suture when second extremity 2116 is tensioned
(described below). The upper surface 2112a of the wedge 2112 forms
a similar angle with the side wall of wedge 2112, forming an acute
angle along the upper edge. The first extremity 2118 of the suture
enters the anchor via aperture 2108 and extends downward into
central channel 2114 and then loops around and partially encircles
the sliding wedge 2112. A second extremity 2116 of the suture S
then extends upward through the central channel 2114 and exits the
anchor through aperture 2108. The sliding wedge 2112 allows the
suture S to be adjusted in one direction while constraining
movement in a second direction opposite the first direction. The
suture may be adjusted in the first direction when the first
extremity 2118 is pulled because the suture S can pass easily
around the sliding wedge 2112. However, when the second extremity
2116 of the suture S is pulled in the second direction opposite the
first direction, the portion of the suture looped around the lower
side of the sliding wedge will pull the sliding wedge upward until
the upper surface 2112a compresses the suture S between the sliding
wedge and the angled wall 2110a of channel 2110 preventing the
suture from moving in the second direction. Moreover, the acute
angle of the upper corner of the wedge provides a sharp edge which
pinches the suture between the sliding wedge and the wall of
channel 2110, increasing resistance of its movement.
[0132] FIG. 34A illustrates a cross-section of another embodiment
of a suture anchor having a cinching mechanism. FIG. 34B is also a
cross-section of the anchor, this time rotated approximately 90
degrees relative to that of FIG. 34A. The anchor 2202 includes a
tapered or pointed tip 2204 that generally takes the same form as
other anchor tips previously described. The anchor also has a
cylindrical housing 2206 that holds the suture and cinching
mechanism and a top surface of the housing includes an aperture
2214 which allows the suture S to enter and exit the anchor. In
this embodiment, a pin 2208 slides along a slot 2210 in a sidewall
of the housing and serves as the wedging element. A first extremity
2218 of suture S enters the anchor through aperture 2214 and
extends downward through a central channel 2212. Central channel
2212 has a sloping sidewall 2220 that narrows the width of the
central channel as aperture 2214 is approached. The suture
partially encircles the sliding pin 2208 and then a second
extremity 2216 of the suture extends upward through the central
channel 2212 and exits the anchor via aperture 2214. Aperture 2214
is laterally offset from the axis along which pin 2208 slides such
that the second extremity 2216 of the suture is directed in a
lateral direction from pin 2208 while the first extremity 2218 is
generally parallel to the axis of movement of pin 2208. In
operation, when the first extremity 2218 of suture S is pulled in a
first direction, the lateral component of the force vector on pin
2208 keeps pin 2208 from being forced upward toward the sloping
wall 2220 and allows the suture S to slip around the pin 2208.
Thus, when the suture is pulled in the first direction, suture
length or tension may be adjusted. When the second extremity 2216
of suture S is pulled in a second direction opposite the first
direction, the forces on the suture will pull the sliding pin
upward along the slot 2210. As the pin moves upward, the space
between the pin and sloping wall 2220 decreases, resulting in the
suture S being compressed between the pin and the sloping wall
2220, thereby locking the suture and preventing it from moving any
further. Thus the cinching mechanism allows the suture to be
adjusted when pulled in one direction and locked in the opposite
direction.
[0133] FIG. 35 illustrates a cross-section of yet another
embodiment of a suture anchor having a cinching mechanism. This
embodiment is similar to that of FIG. 33 except that a stationary
pin is provided in place of the sliding wedge. The anchor 2302
includes a pointed tip 2304 and a cylindrical housing 2306. A pin
2308 is mounted transversely in a central channel 2316. A first
extremity 2314 of suture S enters the anchor through an aperture
2310 and extends downward into central channel 2316 and then the
suture loops around and partially encircles the pin 2308. A second
extremity 2312 then extends upward and out of the anchor through
aperture 2310. Preferably central channel 2316 forms an upper wall
2318 opposite the upper side of pin 2308 which is curved or angled
so as to form an acutely angled edge 2320 around which the first
extremity passes. Suture length or tension may be adjusted by
pulling the first extremity in a first direction and this allows
the suture to pass freely through the anchor and cinching
mechanism. When the second extremity 2312 of the suture is pulled
in a second direction opposite the first direction, the second
extremity 2312 compresses the first extremity 2314 against the wall
of central channel 2316 and against edge 2320, pinching the suture
S therebetween and preventing movement in the second direction. In
alternative embodiments, the pin 2308 may rotate in place about its
longitudinal axis, thereby facilitating the movement of the suture
thereover when the first extremity 2314 is tensioned.
[0134] FIG. 36A illustrates a cross-section of another exemplary
embodiment of a suture anchor having a cinching mechanism. FIG. 36B
illustrates a cross-section of the embodiment in FIG. 36A rotated
approximately 90 degrees. This embodiment is similar to that shown
in FIGS. 34A-34B, except a fixed pin 2412 is provided in place of
the sloping wall of the earlier embodiment. Anchor 2402 includes a
pointed tip 2404 and a cylindrical housing 2406. A sliding pin 2408
is oriented transversely across housing 2406 and moves up and down
along slot 2410 in the housing toward and away from fixed pin 2412
which is mounted transversely near the upper or proximal end of the
housing. Both pins are generally parallel to one another and
transverse to the longitudinal axis of the anchor, preferably
orthogonal. A first extremity 2418 of the suture enters the anchor
via aperture 2414 and extends downward into central channel 2420
crossing under the fixed pin 2412 and looping around and partially
encircling the sliding pin 2408. A second extremity 2416 of the
suture S then extends upward through the central channel and exits
the anchor through aperture 2414. As in the embodiment of FIGS.
34A-34B, aperture 2414 is preferably laterally offset from the axis
along which the sliding pin 2408 slides, so that the first
extremity 2418 of suture S is directed in a lateral direction from
sliding pin 2408 in order to exit through the aperture. When the
first extremity 2418 is pulled in a first direction, the suture S
slips around sliding pin 2408 without forcing it toward fixed pin
2412, allowing suture S to pass freely through the anchor and
cinching mechanism. Thus suture length and tension may be adjusted
by pulling the suture in the first direction. When the second
extremity 2416 is pulled in a second direction opposite the first
direction, the suture pulls the sliding pin 2408 upward along slot
2410 until the suture S is pinched between the sliding pin 2408 and
the fixed pin 2412. Thus the suture cannot move when pulled in the
second direction.
[0135] FIG. 37A illustrates an embodiment of a suture anchor and
cinching mechanism in the unlocked configuration and FIG. 37B
illustrates the suture anchor and cinching mechanism in the locked
configuration. The anchor 2502 has a tapered or pointed tip 2504
similar to those previously described and also has a cylindrical
housing 2506 with a central channel 2516 and an aperture 2508 on a
top surface which allows the suture S to enter and exit the anchor.
A pair of pins 2512, 2514 are mounted to housing 2506 transversely
across central channel 2516 and are separated by a gap. A split
retainer ring 2510 is coupled to an inner wall of housing 2506 so
as to be aligned with the gap. A first extremity 2522 of the suture
S enters the anchor through aperture 2508 and extends downward into
the central channel 2516, passing under the second pin 2514 and
looping back over the top of the second pin 2514 and through the
gap between the two pins. The suture crosses over an intermediate
segment 2518 of the suture which extends across the gap, passes
through the split ring retainer 2510 and then passes back through
the gap between the pins, forming a loop 2524 around the
intermediate segment 2518. A second extremity 2520 of the suture S
then extends upward and exits the anchor through aperture 2508. As
seen in FIG. 37A, when the first extremity 2522 of suture S is
pulled in a first direction, the suture will pass freely through
the anchor and cinching mechanism without pulling out of the split
retainer ring 2510, thereby allowing suture to move so that length
and tension may be adjusted. However, as seen in FIG. 37B, when the
second extremity 2520 of the suture S is pulled in a second
direction opposite the first direction, the suture will pull out
from the split retainer ring 2510 and the loop 2525 will then pull
intermediate segment 2518 into the gap between the pins,
compressing the suture against the pins, and creating friction
which prevents the suture from further movement.
[0136] FIGS. 38A-38B illustrate another embodiment of a suture
anchor having a suture locking mechanism. FIG. 38A is a perspective
view of the suture anchor and FIG. 38B shows a cross section of the
locking mechanism. Anchor 2606 includes a tapered or pointed tip
2601 similar to other tips described above, and the cinching
mechanism includes a locking bar 2602 that slides along a central
wall 2608. Suture S is threaded around the locking bar 2602. In
this embodiment, the locking mechanism uses a floating suture
locking mechanism within the anchor body. The suture S having ends
2603, 2604 is threaded through the floating locking bar 2602 such
that it is activated by pulling one end of the suture to engage the
lock. When the other end is tensioned, the lock can release
providing adjustable tensioning capabilities. The central wall 2608
is configured to receive the sliding locking bar 2602. As tension
on the suture thread end 2603 is increased the sliding member is
pulled proximally locking the suture in position. When tension is
exerted on thread end 2604 the system remains free to move and the
suture slides past the locking bar. The floating locking bar 2602
can be constructed of a different material than the anchor, such as
a compressible material like a soft durometer polymer such as
silicone or urethane. With a softer, compressible material the
suture may be locked as the material compresses around it during
tensioning. In addition, the floating lock may be molded with a
variety of surface features to cause a more secure lock, such as
bumps, ridges or the like.
[0137] FIG. 39 illustrates a variation of the embodiment in FIGS.
38A-38B with the major difference being that the anchor 2702
includes a cylindrical housing 2704 that surrounds the cinching
mechanism and also that the housing has an aperture 2704a on its
top or proximal surface for the suture S to enter and exit the
anchor. In this embodiment, the housing 2704 guides the first and
second extremities 2603, 2604 of suture S along a path parallel to
the axis of movement of the floating locking bar 2602. This ensures
that when first extremity 2603 is tensioned, the force vectors are
in the appropriate direction to pull floating locking bar
proximally, thereby clamping the suture against the central wall
2608.
[0138] FIG. 40 illustrates a variation of the embodiment in FIG.
39, this time the floating locking bar 2602 in anchor 2802 includes
an aperture 2804 in a middle portion thereof that allows the suture
to pass therethrough instead of the suture passing over the top of
the locking bar. This may allow more free movement of the suture
when second extremity 2604 is tensioned, and may increase and the
clamping force of the floating locking bar 2602 when first
extremity 2603 is tensioned.
[0139] FIG. 41 illustrates a cross-section of another embodiment of
a suture anchor and cinching mechanism. The anchor 2902 has a
pointed or tapered tip 2904 similar to those previously described
and also has a cylindrical housing 2906 with a pair of apertures
2914, 2916 which allow the suture S to enter and exit the anchor.
The anchor also has a U-shaped central channel 2922 with a tapered
portion 2908 on one side of the U. The cinching mechanism includes
a split wedge 2924 having opposable jaws 2910 each with a plurality
of teeth 2912 for pinching the suture S. The split wedge is
slidably disposed in the tapered portion 2908 of the central
channel 2922. A first extremity 2918 of suture S enters the anchor
via aperture 2914 and extends downward into the central channel
2922 in between the jaws 2910. The suture exits the jaws and a
second extremity 2920 of suture S passes through the bottom portion
of the U shaped channel and exits the anchor through aperture 2916.
In use, when the first extremity 2918 of the suture S is pulled in
a first direction away from the anchor, wedge 2924 is pulled
proximally in tapered channel 2908, allowing jaws 2910 to separate.
This allows the suture to pass freely through the U-shaped channel
and the jaws thereby allowing the suture length or tension to be
adjusted. However, when the second extremity 2920 of the suture is
pulled in a second direction opposite the first direction, away
from the anchor, the suture will pull the split wedge 2924 downward
into the tapered portion of the channel such that the jaws pinch
the suture and the teeth 2912 bite into the suture, constraining
suture movement relative to the anchor.
[0140] FIG. 42 illustrates a cross-section of another suture anchor
embodiment. Anchor 3002 includes a tapered or pointed tip 3004
similar to those described above and has a cylindrical housing 3006
having a central channel 3022 and two apertures 3008, 3010 on the
proximal or top surface of the housing for the suture S to enter
and exit the anchor. An arm 3014 having a free distal end 3024 and
an aperture 3012 in a proximal portion thereof is fixed to a wall
of the anchor and cantilevers into the central channel. Preferably,
distal end 3024 of arm 3014 has a beveled tip, preferably being
beveled only on one side (e.g. the upper side as shown) or with a
steeper angle on one side than the other, so that the tip engages
the suture more readily when pulled in one direction vs. the other.
For the same purpose, arm 3014 may be mounted non-orthogonally to
the suture path (e.g. angled downwardly as shown), or constructed
so as to resiliently deflect or bend preferentially in one
direction vs. the other. A pin 3016 generally transverse to the
longitudinal axis of the central channel is mounted near the bottom
of the central channel. A first extremity 3018 of suture S enters
the anchor via aperture 3010 and travels downward into the central
channel 3022 and passes through aperture 3012. The suture then
passes under the pin 3016 and past the distal end of the arm 3014.
A second extremity 3020 of the suture then exits the anchor via
aperture 3008. When the first extremity 3018 of the suture S is
pulled in a first direction away from the anchor, arm 3014 deflects
in the direction of suture movement and the suture S will pass
freely through the anchor and cinching mechanism, allowing suture
length or tension to be adjusted. However, when the second
extremity 3020 is pulled in a second direction opposite the first,
away from the anchor, the beveled tip of arm 3014 engages the
suture and is pulled toward the opposing inner wall of the central
channel, thereby pinching the suture and preventing its movement.
The arm may be resilient and deflectable in which case the arm will
deflect upward as the suture is pulled in the second direction and
therefore the suture will be pinched between the arm and the wall
of the central channel. Alternatively, the arm may be rigid but
have a sharp tip that catches the suture and mechanically
constrains it as it is pulled past the tip in the second direction.
The suture may be round or flat and in some embodiments, the suture
may have surface features which help it engage with the arm. For
example, a flat suture may have discrete holes or ridges on it
(similar to a cable tie).
[0141] FIG. 43 is a schematic illustration of another suture anchor
and locking mechanism. The anchor 3302 includes a pointed or
tapered tip 3304 similar to those described above and also has a
cylindrical housing 3306 with a central channel 3318. This
embodiment is similar to that described above and illustrated in
FIG. 42, having an arm 3316 cantilevered from a wall of the central
channel with a distal tip configured to engage suture S. In place
of pin 3016 in FIG. 42, this embodiment has a post 3308 secured to
the bottom of the central channel 3318 with a passage 3310 through
post 3308. A first extremity 3312 of the suture S enters the top of
the anchor and passes through an aperture 3320 in the arm. The
suture then passes through the passage 3310 in post 3308 and then
the suture extends upward past the arm and a second extremity 3314
of the suture S exits the anchor. This embodiment works in
substantially the same manner as embodiment in FIG. 42.
[0142] FIG. 44 is a schematic illustration of a suture anchor and
locking mechanism. The anchor 3402 includes a pointed or tapered
tip 3404 similar to those described above and also has a
cylindrical housing 3406 having a central channel 3418 and an
aperture 3408 on the top of the housing. An aperture 3416 passes
through a sidewall of the housing near the bottom of the central
channel and an arm 3410 is attached to a sidewall of the central
channel and the arm cantilevers into the central channel. A first
extremity 3412 of the suture S extends downward along an outer
surface of the anchor and enters the central channel via aperture
3416. Preferably, a longitudinal channel or recess (not shown) is
provided in the outer wall of the anchor which receives the suture
and allows it to slide easily even when the anchor is placed in
bone. The suture then passes around the arm and a second extremity
3414 exits the anchor via aperture 3408. The cinching mechanism
operates substantially similarly to the embodiments described in
FIGS. 42 and 43 above.
[0143] FIG. 45 shows another schematic of a suture anchor and
locking mechanism. Anchor 3502 includes a pointed or tapered tip
3504 similar to those described above and the anchor also has a
cylindrical housing 3506 with a central channel 3524 and having
passages 3508 and 3510 through a sidewall of the housing and
passage 3518 through a sidewall on the opposite side of the
housing. An aperture 3522 is on the top of the housing so that the
suture may enter and exit the anchor. An arm 3512 is attached to a
sidewall of the central channel and extends outwardly into the
central channel like a cantilevered beam. An extremity of the
suture 3516 enters the anchor via aperture 3522 and then passes
downward in the central channel and has a tip engaging segment 3528
that passes around the tip of arm 3512. The suture then exits the
anchor via passage 3508, travels a short distance along an outer
surface of the anchor and re-enters the anchor via passage 3510,
crossing the channel and then again exiting the anchor via passage
3520. The suture re-enters the anchor via passage 3518 and forms a
loop 3526 around the tip-engaging segment 3528 extending around arm
3512, the suture then exiting through passage 3518. The suture then
extends upward along an outer surface of the anchor. Preferably,
channels or recesses (not shown) are provided in the outer wall of
the anchor to receive those extremities of the suture extending
along the exterior to allow the suture to slide easily even when
the anchor is placed in bone. In operation, when the suture is
pulled in the direction of end 3514, the suture loop 3526 will pull
the tip-engaging segment 3528 of the suture away from the arm
thereby allowing the suture to move relative to the arm so that
suture tension or length may be adjusted. When the suture is pulled
in the opposite direction by tensioning end 3516, the suture is
pulled into engagement with the arm, preventing the suture from
passing, and thus the suture is locked.
[0144] FIG. 46 is a schematic illustration of another suture anchor
embodiment with locking mechanism. Anchor 3602 includes a tapered
or pointed tip 3604 similar to those previously described above. A
cylindrical housing 3606 includes a central channel 3612 and a pair
of passages 3608, 3610 in a sidewall of the housing. An extremity
3618 of the suture S enters the anchor from the top of the central
channel and extends downward into the channel. The suture then
exits the anchor via passage 3608 and passes along an outer surface
of the anchor and then re-enters the anchor via passage 3610.
Again, a longitudinal channel or recess (not shown) is preferably
provided on the outer wall of the housing 3606 between passages
3608, 3610 to receive the suture and allow it to slide freely
without interference by surrounding bone or tissue. The suture then
extends upward and an extremity 3614 of the suture S exits the
anchor via the top of the channel. The passages 3608, 3610 may be
angled so that the suture may pass through them in one direction,
while resistance is met in the opposite direction. Thus, in this
embodiment, when suture extremity 3618 is pulled away from the
anchor, it will pass freely through the passages allowing suture
length or tension to be adjusted. However, when suture extremity
3614 is pulled away from the anchor, suture extremity 3614
compresses suture extremity 3618 against the inner wall of the
central channel 3612, constraining the suture from moving.
[0145] FIG. 47 is another schematic illustration of a suture anchor
having a sliding clamping element. Anchor 3702 includes a tapered
or pointed tip 3704 similar to those described above. The anchor
also has a cylindrical body 3706 with a central channel 3712
extending therethrough. A pair of passages 3708, 3710 extend
through a sidewall on one side of the anchor and another passage
3720 extends through the sidewall on an opposite side of the
anchor. A sliding clamp 3718 is disposed in central channel 3712 so
that it may travel up and down the central channel (e.g. the
sliding clamp may be free-floating or may ride in slots in the
sidewall of the anchor). A rigid stop 3714 is fixed in the central
channel above (proximally of) the sliding clamp. A first extremity
3722 of the suture S extends downward and runs alongside an
exterior surface of the anchor and then enters the anchor via
passage 3720. The suture crosses the central channel through a
transverse passage 3716 between the sliding clamp 3718 and the
rigid stop 3714. The suture exits the anchor via passage 3708 and
passes along an outer surface of the anchor and then re-enters the
anchor via passage 3710, extending downward and under the sliding
clamp 3718. A second extremity 3724 of the suture S then exits the
anchor via passage 3720. Longitudinal channels or recesses (not
shown) are preferably provided on the outer wall of the body 3706
between passages 3708, 3710 and from passage 3720 to the proximal
end of the anchor to receive the suture and allow it to slide
freely without interference by surrounding bone or tissue. In
operation, the first extremity 3722 of suture S may be pulled in a
first direction away from the anchor without binding, thereby
allowing suture length or tension to be adjusted. When the second
extremity 3724 of suture S is pulled away from the anchor in a
second direction opposite the first direction, the suture will pull
the sliding clamp 3718 upward, pinching the suture between the top
of the sliding clamp and the bottom of the rigid stop 3714, thereby
locking the suture in position.
[0146] FIG. 48 illustrates another embodiment of a knotless
cinching mechanism which has an optional feature to allow two-way
suture movement and selective conversion to one-way cinching
function. Anchor 4002 includes a cylindrical housing 4004 and may
have any of the distal tips described herein. The housing 4004 has
apertures 4022, 4024 on the top surface that form an entrance to
and an exit from a U-shaped channel 4026 that holds a part of the
suture S. A central post 4006 joins the top of the housing 4004
with an end plate 4008 having apertures 4010, 4012 therethrough. An
optional lubricious sheath or suture cover 4014 is removably
positioned through aperture 4012 so as to enclose a portion of the
suture along post 4006 distal to aperture 4012. A first extremity
4016 of suture S enters aperture 4012 and extends downward
alongside the central post 4006 entering the U-shaped channel 4026
via aperture 4024. The suture travels through the U-shaped channel
and travels upward, exiting the U-shaped channel via aperture 4022.
The suture then loops around the central post 4006, forming a loop
4020 which partially encircles the central post along with sheath
4014 and the first extremity 4016 of suture S. A second extremity
4018 of the suture S then extends upward and passes through
aperture 4010 in the end plate 4008. The lubricious sheath 4014
covers a portion of the suture S extending through aperture 4012
and also a portion of the suture S underneath loop 4020. The
lubricious sheath has sufficient radial strength to keep from
collapsing on the underlying suture when loop 4020 is cinched down,
and lubricous enough to allow the suture to slide through it. When
the sheath 4014 is positioned over the suture, either the first
extremity 4016 or second extremity of suture S may be pulled away
from the anchor and the suture will pass freely through the anchor
and cinching mechanism since the suture will glide through the
lubricious sheath even though loop 4020 may be tightening around
it. Once the sheath 4014 is refracted or removed the suture
underlying loop 4020 may be engaged by the loop such that, when the
second extremity 4018 of suture S is pulled in a second direction
away from the anchor and opposite the first direction, loop 4020
will cinch down on first extremity 4016 to compress it and create
friction between the suture and the central post, preventing the
suture from moving in the second direction. Even with the sheath
removed, however, applying tension to first extremity 4016 in the
first direction will allow the suture to move. If a sufficiently
flexible material is used, sheath 4014 may extend proximally over
suture S a sufficient distance to allow the surgeon to grasp it.
Alternatively, sheath 4014 may comprise a short and more rigid
segment and it may be coupled to a flexible tether or length of
suture (not shown) which may extend away from the surgical site,
preferably out of the patient's body, to allow the surgeon to
retract or remove the sheath at the desired time. It will be
understood that the embodiment illustrated in FIG. 40 may also be
used without sheath 4014, wherein it will operate solely as a
one-way cinching mechanism as with other embodiments described
herein.
[0147] FIG. 49A illustrates another exemplary embodiment of a
suture anchor having a locking mechanism. FIG. 49B schematically
illustrates a side cross-sectional view of FIG. 49A. The anchor
4102 may have a cylindrical housing (not illustrated) and tip (not
illustrated) similar to other embodiments described above and a
central wall 4108 may be disposed in the anchor housing. Upper and
lower apertures 4106, 4104 are disposed in wall 4108. A removable
wedge element 4114 (best seen in FIG. 49B) is positionable in the
anchor between a first extremity 4112 of the suture and a second
extremity 4110 of the suture. The wedge element 4114 is arch-shaped
on its inner side facing wall 4108 so as not to clamp the first
extremity 4112 of suture S against wall 4108 and to allow suture S
to slide. Wedge element 4114 may also include a longitudinal groove
or channel 4116 on its outer side to receive the second extremity
4110 of the suture and allow it to slide. Wedge element 4114
preferably has a distal end which has a curvature or angle selected
to guide suture S in a more lateral direction away from lower
aperture 4104 so as to minimize friction with wall 4108 adjacent to
the aperture. The first extremity 4112 of the suture S extends
downward and substantially parallel with the central wall entering
aperture 4106 from a first side and then travels along an outside
surface of the central wall, entering aperture 4104 from a second
side opposite the first side. The suture S then loops around the
removable wedge element partially encircling it. A second extremity
4110 of the suture S then extends upward and out of the anchor.
Thus, when the removable wedge element is disposed in between the
suture and the central wall, the second extremity of the suture
gently exits aperture 4104 and gently curves around the wedge. When
the first extremity 4112 of the suture is pulled in a first
direction away from the anchor, the suture will pass freely through
the apertures of the central wall and thus the suture length or
tension may be adjusted. Additionally, with the wedge element in
place, the second extremity 4110 of the suture S may also be pulled
in a second direction opposite the first direction and away from
the anchor and the suture will also move freely through the
cinching mechanism. Thus the suture S may be tightened or loosened
by pulling the suture in either the first or the second direction.
When the removable wedge element 4114 is removed from its position
between the suture and the central wall, the angle that the suture
exits aperture 4014 will increase and be close to perpendicular and
the second extremity 4110 is allowed direct contact with first
extremity 4112. Thus, when the second extremity 4110 of the suture
S is pulled in the second direction, the suture will bind against
an edge of aperture 4104 and second extremity 4110 will compress
first extremity 4112 against wall 4108, preventing the suture from
moving in the second direction. The apertures 4104, 4106 may be
angled non-orthogonally to the face of the wall to optimize
slidability and friction in different directions. For example, one
or both of apertures 4104, 4108 may be angled to slope downward
(distally) toward the inner side of the wall so as to create a
sharper edge along the upper side of the aperture thereby
increasing resistance on suture movement. Moreover, the shape of
the removable wedge 4114 may also be adjusted to optimize
slidability of the suture in the first and second directions. FIG.
49C illustrates the cinching mechanism when the removable wedge has
been removed.
[0148] FIGS. 50A-50C illustrate cross-sections of another
embodiment of a knotless suture anchor system having an outer
anchor 7802 and an inner anchor 7816. FIG. 50A shows the anchor
unloaded, FIG. 50B shows a suture S being loaded into the anchor,
and FIG. 50C shows the anchor locked. The outer anchor 7802 has a
central channel 7810 with internal threads or ribs 7804 for
engaging the threads or ribs 7806 on the inner anchor 7816. A
suture or wire guide 7810 forming a loop 7811 with legs 7810a,
7810b, is attached to the inner anchor 7816 and passes through an
axial passage 7812a in a strangling member 7812 so as to act as a
rail over which strangling member 7812 slides. In use, the inner
anchor 7816 is retracted proximally or unthreaded sufficiently so
that the strangling member 7812 is exposed from the central channel
7810. As seen in FIG. 50B, a lasso 7814a of suture, wire, or other
flexible material passes through loop 7811 in wire guide 7810,
around one side of strangling member 7812 and between the legs
7810a, 7810b of wire guide 7810 on the lower side of strangling
member 7812 and has a free end 7814b and a capture loop 7814c on
the opposite end. The anchor system is pre loaded with lasso 7814a
threaded in this manner so that after a suture is passed through or
around the tissue to be repaired, the suture ends may be passed
through the capture loop 7814c and the free end of lasso 7814a then
pulled to draw the suture through the wire guide loop both distally
and proximally of strangling member 7812. Thus the one-way cinching
mechanism may be threaded with a suture by the surgeon during a
surgical procedure. The inner anchor 7816 is then advanced distally
into the central channel 7808 so that the strangling member 7812 is
disposed in the central channel and the two ends 7814a, 7814b
extend proximally from the anchor 7802, as seen in FIG. 50C. Thus,
when free end 7814a is pulled, the length or tension of suture S
may be adjusted. However, when free end 7814b is pulled, the suture
S will force the strangling member 7812 to move upward along the
wire guide 7810 until the suture is pinched between a top portion
of the strangling member 7812 and the wire guide 7810, thereby
preventing further movement of the suture.
[0149] FIGS. 51A-51B illustrate another exemplary embodiment of a
suture anchor cinching mechanism. FIG. 51A shows a schematic of the
anchor and FIG. 51B illustrates a cross-section of the anchor. The
anchor 7602 has a generally cylindrically shaped housing with a
pointed distal tip 7604, a central channel 7606, and a strangling
shuttle 7608 that slides along a suture or wire guide 7610. The
wire guide 7610 has both ends 7612a, 7612b attached to a lower
portion of the anchor 7602 and a looped region 7614 extends through
a central passage 7607 through the strangling shuttle 7608. A
suture S extends through the loop 7614 on one side of strangling
shuttle 7608 and is wrapped around the shuttle 7608 passing between
the two legs 7610a, 7610b of wire guide 7610 on the opposite side
of strangling shuttle 7608 such that both free ends 7616a, 7616b
extend proximally from the anchor 7602. In use, when free end 7616b
is pulled, the length or tension of suture S may be adjusted as the
suture will slide around the strangling shuttle 7608. However, when
the other free end 7616a is pulled, the strangling shuttle 7608
will be pulled up and slide along the wire guide 7610 until a
portion of the suture S is pinched between the top surface of the
strangling shuttle 7608 and the loop 7614 of the wire guide 7610.
Once pinched, the suture S will be constrained from further
movement. Thus, the cinching mechanism allows one-way adjustment of
the suture. FIG. 51C illustrates a perspective view of the
strangling element 7608, except this time with two sutures S
passing therearound. Thus, the cinching mechanism may be used to
allow one-way adjustment of more than one suture. In this
embodiment, free ends 7616a, 7618a may be pulled to adjust length
or tension in the sutures, while pulling the opposite free ends
7616b, 7618b will lock the suture and prevent further movement.
[0150] FIGS. 52A-52B illustrate still another exemplary embodiment
of a knotless suture anchor system having an outer anchor 7702 and
an inner tissue piercing anchor 7712. The outer anchor 7702 has a
generally cylindrically shaped body with a tapered distal tip 7704,
a central channel 7706 and a transverse channel 7720. Concave
channels 7708, 7710 run axially along the outer surface of the
outer anchor 7702 and allow suture S to seat therein without being
pinched between the anchor and the bone. The outer anchor also has
a floating element 7728 (seen in FIG. 52B) which slides axially
along the central channel 7706. The inner tissue piercing anchor
7712 has a sharp pointed distal tip 7716 that allows the inner
anchor 7712 to pass easily through tissue such as a torn labrum or
rotator cuff and has ribs or threads 7714 or other surface features
for engaging the corresponding surface features 7724 on the inner
surface of outer anchor 7702. A length of suture S is attached with
a knot 7718, crimp or other means to the inner anchor 7712. The
suture then runs along an outer surface of the outer anchor 7702 in
channel 7708 and passes through transverse channel 7720 and extends
up along an opposite surface of the anchor 7702 in channel 7710. A
free end 7722 extends proximally away from the anchors 7702, 7712.
In use, damaged tissue (not illustrated) is captured by passing the
piercing anchor 7712 therethrough or by looping the suture
therearound to create a repair loop 7726. The inner anchor 7702 is
then threaded or pushed into the central channel 7706 of the outer
anchor 7702. As the inner anchor 7712 is advanced into the central
channel 7706, it engages the floating element 7728 and forces the
floating element downward until it pinches the suture passing
through the transverse channel 7720, thereby locking the suture in
position. An advantage of this type of suture anchor is that the
inner anchor may be released from the outer anchor by unthreading,
thereby allowing additional adjustments to suture length or
tension.
[0151] Deployment:
[0152] Suture anchors often are placed into pre-drilled holes in
the bone or other tissue substrate to which damaged tissue is to be
re-attached. FIG. 53 shows a pre-drilled hole 4402 obscured by a
torn labrum L that is to be re-attached to the rim R of an
acetabulum A. In the case of re-attaching a torn labrum to an
acetabular rim, the holes are positioned underneath the torn labrum
and they may be difficult to see or locate with arthroscopic
instruments after the drill or hole punch is removed since the
labrum will cover the hole and obscure its location. This makes it
difficult to find and position the suture anchor into the hole
during the surgical procedure. This problem may become even more
acute after delivering a first anchor and attempting to deliver a
second anchor into the same pre-drilled hole. With the labrum
captured by the suture extending between the two anchors, it
becomes more difficult to move the labrum out of the way in order
to locate the target hole for the second anchor. FIG. 54
illustrates a method for locating a pre-drilled hole. A suture
anchor delivery instrument 4504 may include an optical coupling
4502 so that an external light source (not shown) may be optically
coupled to the suture anchor delivery instrument 4504. Thus, light
will be delivered from a light source through a light pipe such as
a fiber optic to the area adjacent the pre-drilled hole 4508. The
light 4506 illuminates the area with enough intensity and with a
suitable wavelength so that the light is transmitted through the
labrum L to illuminate the underlying bone and hole 4508. The light
may be from an LED, laser or other suitable source. The light pipe
may comprise one or more optical fibers or other suitable light
transmission means and may be disposed in a lumen in the delivery
instrument or in a separate member which is positioned alongside
the delivery instrument or coupled to its exterior. With the
location of the pre-drilled hole visible, the surgeon may deliver
the suture anchor into the hole using the delivery instrument.
[0153] FIG. 55 illustrates a variation of the embodiment in FIG.
19. In this exemplary embodiment, two anchors 92, 96 are placed
end-to-end into engagement with one another. This variation is
similar to that of FIG. 19, with the major difference being that
the coupling element 94 is fixed to the top or proximal-most anchor
96 instead of on the bottom or distal-most anchor 92. The coupling
element 94 may take any of forms previously described with respect
to coupling element 83 in FIG. 19. Additionally, in this
embodiment, a pusher tube 98 may be used to help drive anchor 96
into the bone or to help drive the two anchors into engagement with
one another. A distal end 98a of the pusher tube 98 may be placed
against a shoulder 96a of the upper anchor 96 and used to press the
two anchors together. Alternatively, the proximal end of the pusher
tube 98 may also be impacted with a hammer or similar object to
help drive the two anchors into the bone and into engagement with
one another. It will be understood that the distal and proximal
anchors 92, 94 will be coupled to a length of suture and will
include a knotless cinching mechanism in one or both anchors as
described elsewhere herein.
[0154] FIGS. 56A-56B illustrate an exemplary embodiment of a
delivery instrument for deploying suture anchors in an end-to-end
configuration. FIG. 56B is a cross-section of FIG. 56A and
highlights the internal components of the delivery instrument. An
outer shaft 1102 carries both anchors 1104, 1116 and a suture 1110
is coupled to each anchor. A plurality of slots 1106 near the
distal end of the outer shaft 1102 form several deflectable arms
1114. Deflectable arms have inwardly extending fingers 1118 at
their distal end which engage the proximal end of the distal anchor
1104. Pusher rod 1108 is slidably disposed in outer shaft 1102 and
is engaged with the proximal end of suture anchor 1116. The distal
end of anchor 1116 is also engaged with the proximal end of anchor
1104. Coupling mechanisms 1112 such as snap fits, threaded rods, or
other joining mechanisms are used to join the two anchors 1104,
1116 together as described above. In use, pusher rod 1108 is
slidably advanced within outer shaft 1102 so that the first anchor
1104 is exposed from the distal end of outer shaft 1102. As the
pusher rod advances the first anchor 1104 distally, the arms 1114
deflect radially outward until the anchor 1104 is exposed distally
thereof. The arms 1114 return to their radially inward position and
thus the fingers 1118 at the distal end of the arms 1114a can then
be used to push the first anchor into the bone or the pre-drilled
hole in the bone. Shaft 1102 and pusher rod 1108 are then retracted
along with proximal-most anchor 1116 to decouple it from the
distal-most anchor 1104. Once the first anchor is in place, the
instrument is manipulated so as to capture the target tissue with
the suture 1110. Pusher rod 1108 is then advanced within shaft 1102
to push proximal-most anchor 1116 beyond fingers 1118 on
deflectable arms 1114. The deflectable arms flare outwardly as the
second anchor is advanced past the arms, and then the arms return
to their unbiased position where they can be used to push the
second anchor into the bone or the hole and also into engagement
with the first anchor 1104. Once the two anchors have been coupled
together (e.g. by threading them together or snap fitting or press
fitting them together), the pusher rod 1108 may be released from
the second anchor 1116 by unthreading, unsnapping or otherwise
uncoupling the coupling mechanism 1112 between the two
components.
[0155] FIG. 57 illustrates another method of locating a suture
anchor hole without requiring that a drill guide is kept in place.
Once a hole 7904 has been pre-drilled into the bone 7902 a first
anchor 7906 to which a guide filament S of wire, suture or other
flexible material is coupled may be positioned into the hole 7904.
Guide filament S may be used to help direct a delivery instrument
7908 carrying a second anchor 7909 through the tissue and blood,
back to the hole 7904. Guide filament S may pass slidably through a
loop, lasso 7910 or other coupling mechanism on the second anchor
7909 or delivery instrument 7908 over which it can be advanced back
to the hole 7904. In this manner, the delivery instrument 7908 may
be advanced along the guide filament S easily back to the hole 7904
to deliver additional suture, suture anchors or other materials
required for the surgical repair. First anchor 7906 need not have
the level of retention force that is required for the second anchor
which is to be used in the surgical repair itself, needing only to
hold the guide filament S while it is tensioned sufficiently to
guide instruments back to hole 7904. First anchor 7906 may thus be
a self expanding resilient wire coil or ball of randomly bent wire,
a self-expanding stent-like structure, or a more rigid
frictionally-retained structure adapted to be pressed or pounded
into hole 7904. Alternatively, first anchor 7906 may have scales,
barbs, wings or similar expanding structures on its outer surface
to retain it within the hole. Any of the embodiments of the anchors
disclosed elsewhere herein may also be used.
[0156] FIGS. 58A-58H illustrate another exemplary method of
re-attaching damaged tissue to a substrate tissue such as bone
using a single anchor with a closed loop. A suture passer and
anchor delivery instrument 8402 carries an anchor 8406 (best seen
in FIG. 58E), a suture S and a pair of curved grasping jaws 8404a,
8404b within the outer shaft 8422. The distal tips 8416a, 8416b of
jaws 8404a, 8404b are sharpened so as to penetrate tissue. Jaws
8404a, 8404b have a discontinuous eyelet, hook, or other means (not
shown) near their distal tips to releasably hold a loop of suture S
between them and are rotatable about the longitudinal axis of the
instrument 8402 so that the distal tips 8416a, 816b of the jaws are
movable from a closed position adjacent to one another to an open
position in which they are spaced apart with the suture extending
between them. The instrument 8402 is advanced adjacent the damaged
tissue, here a torn labrum L as seen in FIG. 58A. The grasping jaws
8404a, 8404b are then deployed from the instrument 8402 and passed
through the torn labrum L in FIG. 58B in the closed position. A
suture loop (not visible in the figure) is carried by the jaws and
is thus passed through the labrum therewith. The instrument 8402 is
then positioned so that it is substantially perpendicular to the
torn tissue or in any other desired orientation, as illustrated in
FIG. 58C. In FIG. 58D, the grasping jaws 8404a, 8404b are then
opened after passing through the labrum so that a portion of the
suture S passes between both jaws, thus opening loop 8420 in the
suture. The anchor 8406 is the deployed from the instrument 8402 in
FIG. 58E such that the anchor passes between the jaws 8404a, 8404b
and through the loop 8420. An inner shaft 8424 carrying anchor 8406
is advanced from the outer shaft 8422 of the instrument 8402, to
drive the anchor directly into the bone or into a pre-drilled hole
as seen in FIG. 58F. Once the anchor 8406 is positioned in the
acetabulum, inner shaft 8424 is decoupled from the anchor 8406 and
the instrument 8402 may be retracted away from the bone, exposing
the three segments of suture S extending from anchor 8406, as seen
in FIG. 58G. The jaws are then decoupled from the suture loop and
refracted back through the labrum and the instrument 8402 is
removed, as illustrated in FIG. 58H. The free end 8410 of the
suture S may then be pulled in order to adjust length or tension of
the suture and secure the labrum with the acetabulum. The anchor
may have any of the cinching mechanisms described above.
[0157] FIGS. 59A-59D illustrate an alternative embodiment of a
suture anchor delivery instrument and method of use. A hole 4612 is
pre-drilled in the acetabulum A as seen in FIG. 59A. A suture
anchor delivery instrument 4602 includes a tubular shaft 4620 and a
grasping mechanism having a pair of opposable jaws 4604, 4606 and a
penetrating needle 4608 slidably mounted within the tubular shaft
4620. The penetrating needle has a hook 4608a formed near its
distal end which is adapted to grasp a suture held by fixed jaw
4604 as described below. A C-shaped fixed jaw 4604 extends from the
distal end of tubular shaft 4620 and forms a channel 4622
configured to receive the target tissue to be repaired. A movable
jaw 4606 is pivotably mounted to tubular shaft 4620 and is movable
so as to extend across the open side of channel 4622. A suture S is
coupled with a knot 4616 or by other means to a first anchor 4610
and extends through fixed jaw 4604 into tubular shaft 4620. The
first anchor 4610 is releasably held at the distal end of fixed jaw
4604 to extend distally therefrom. In use, first anchor 4610 is
deployed from the fixed jaw 4604 into the hole 4612 and then the
torn labrum L is positioned in channel 4622 and retained therein by
closing movable jaw 4606. The piercing needle 4608 is then advanced
across channel 4622 and through the torn labrum L until it engages
and captures the suture S held by fixed jaw 4604, as seen in FIG.
59B. The needle is retracted, pulling the suture S through the
labrum. The instrument is then removed, with the suture S being
slidably advanced from the tubular shaft 4620. A second anchor
4616, preferably having one of the cinching mechanisms described
herein, is then coupled to the suture as illustrated in FIG. 59C.
The second anchor 4616 is then positioned end-to-end or
concentrically with the first anchor 4610 in hole 4612 as described
elsewhere herein. Alternatively second anchor 4616 may be placed in
a separate hole in the acetabulum A. The free end 4618 of the
suture S may then be pulled in order to adjust length and tension
in the suture as desired and to secure the torn labrum L securely
to the acetabular rim substrate.
[0158] An exemplary instrument for delivering a suture anchor is
schematically illustrated in FIGS. 60A-60B. The delivery instrument
7202 includes an elongate outer shaft 7224 having a central channel
7222 in which the suture anchor 7204 and suture S are disposed.
Suture anchor 7204 may taken the form of any suture anchor
disclosed herein. An optional pusher tube 7218 is also disposed in
channel 7222 along with a suture spreader 7206 having a pair of
spreadable arms 7208a, 7208b coupled to an elongate shaft 7216. The
free ends 7212, 7214 of the suture S extending away from the suture
anchor 7204 may extend through the central channel 7222 toward a
proximal end of the delivery instrument 7202 so that the ends may
be manipulated by a physician outside of the patient's body, or the
suture ends may only advance a short distance in the central
channel 7222. In operation, the delivery instrument 7202 is
advanced toward a treatment site and the suture spreader 7206 is
advanced from the central channel 7222 so that the arms 7208a,
7208b are unconstrained and expand outward. The suture S is coupled
to both arms 7208a, 7208b such that when the arms expand outwardly,
the suture S forms a loop 7210 as seen in FIG. 60B. The suture
spreader 7206 may be a superelastic or shape memory material such
as Nitinol that is pre-shaped to spread to a desired configuration.
The suture S may be looped around the tissue to be repaired (e.g.
torn labrum, not illustrated) and then anchor 7204 is then advanced
distally out of the central channel 7222 and passes through the
suture loop 7210 into a hole 7220 pre-drilled in bone. The suture
anchor 7204 may be advanced out of the central channel 7222 by
actuating the pusher tube 7218 or other mechanisms may be employed.
The free ends 7212, 7214 of the suture S can then be pulled in
order to adjust length or tension in the suture S and the excess
suture may be severed. In this embodiment, the suture anchor 7202
is advanced independently from the suture spreader 7206, however in
alternative embodiments the two may be operatively coupled together
so that they are both advanced from the delivery instrument
together.
[0159] The suture spreader 7206 in FIGS. 60A-60B is formed from a
wire-like material and the suture is coupled to arms 7208a, 7208b
preferably by passing the suture S through eyelets (not
illustrated) at the ends. This configuration is advantageous
because it presents a low profile that may be easily be contained
in shaft 7224. FIG. 61A illustrates the suture spreader arms 7304a,
7304b in greater detail. Each arm includes an upper finger 7306 and
a lower finger 7318 that are biased to form an eyelet loop 7310 and
so that the tips of the fingers close against one another forming a
slit 7312. The suture S may be passed through the eyelet loop 7310
on each suture spreader arm 7304a, 7304b. The eyelet loop 7310 may
be sized so that the suture S is loosely held by the fingers 7306,
7318 and thus when the spreader arms 7304a, 7304b expand outward,
arms will open up forming suture loop 7305 without binding.
Moreover, the slit 7312 in each spreader arm 7304a, 7304b allows
the suture S to be disengaged from the spreader by pulling the
suture therepast which spreads the fingers 7306, 7318 apart,
opening the slit enough to release the suture S. FIG. 61B
illustrates a side view of the suture spreader arm 7304a, 7304b. In
an alternative embodiment shown in FIG. 61C, the fingers 7306a,
7306b are shaped to form a smooth arcuate tip 7314 that will not
cause trauma to adjacent tissue as it is advanced and
manipulated.
[0160] An alternative embodiment of a suture spreader is
illustrated in FIGS. 62A-62B. The suture spreader 7402 includes a
pair of substantially cylindrical arms 7404, 7406 that extend
substantially parallel to one another. The suture S may be wrapped
7412 around each arm during deployment but may be easily slid off
from each arm 7404, 7406 when the suture spreader 7402 is detached
from the suture S. The arms 7404, 7406 may be fabricated from a
metallic or polymer wire or pins, or they may be machined from a
single integral piece and may be superelastic, shape memory or
spring temper to spring outwardly upon deployment from a delivery
instrument. The embodiment in FIG. 62A may include arms 7404, 7406
having a straight section for wrapping the suture S therearound and
a flat cylindrical end 7414, or a rounded distal tip 7418 as seen
in FIG. 62B to minimize trauma to adjacent tissue during deployment
as well as to facilitate insertion into the treatment area.
[0161] FIG. 63 illustrates another alternative embodiment of a
suture spreader. The suture spreader 7502 includes a pair of
substantially parallel arms 7504, 7506. Each arm includes a pair of
fingers 7508, 7510 that form a receiving slot 7512 for receiving
the suture S. The receiving slot 7512 may be sized to accommodate a
number of different suture sizes and geometries. Similar to other
suture spreaders described above, the arms 7504, 7506 will expand
outwardly upon release from the delivery instrument, thereby
forming a large suture loop 7305 (FIG. 61A) through which the
suture anchor may pass. The arms may be fabricated from similar
materials as discussed above with reference to FIGS. 61A-61C and
FIGS. 62A-62B.
[0162] FIGS. 64A-64H illustrate an exemplary method of using a
suture anchoring system having an anchor and a needle to reattach a
torn labrum to the acetabular rim A. FIG. 64A shows the labrum L
torn from the acetabular rim A. In FIG. 64B, the torn labrum L is
moved to one side and a delivery instrument 6702 is used to
position a suture anchor 6704 into the acetabular rim. The anchor
may be driven through the cartilage into the bone of the acetabulum
or the anchor may me positioned in a pre-drilled hole. The delivery
instrument 6702 is then retracted away from the anchor such that
suture S is metered out and partially encircles the torn labrum L,
as shown in FIG. 64C. One end of the suture is attached to the
anchor 6704 and the other end of the suture S is attached to a
tissue piercing needle 6706 carried by the delivery instrument
6702. After partially encircling the torn labrum with the suture S,
the needle 6706 is advanced from the delivery instrument so that it
pierces the torn labrum L as illustrated in FIG. 64D. FIG. 64E
shows a pusher rod 6708 advanced from the delivery instrument 6702
so as to push the needle 6706 through the labrum L and into a
central channel of the anchor 6704. A locking mechanism (not
illustrated) couples the needle and the anchor together and the
delivery instrument is then retracted away from the torn labrum L,
metering out additional suture, creating a free end 6710 as seen in
FIG. 64F. The delivery instrument is then removed from the surgical
field as shown in FIG. 64G and then the surgeon can adjust tension
in the suture by pulling the free end 6710 of the suture and
cutting away and excess suture. The labrum L is now re-attached to
the acetabular rim A where it will heal. This process may be
repeated as many times as required along the length of the torn
labrum.
[0163] FIGS. 65A-65H illustrate another exemplary method of
re-attaching tissue. In FIG. 65A a torn labrum L is shown separated
from the acetabular rim A. A delivery instrument 6802 is used to
push the labrum L aside and insert an anchor 6804 into the
acetabulum A, as shown in FIG. 65B. The anchor 6804 may be inserted
directly into the acetabular rim A or in a hole pre-drilled in the
acetabulum A. In FIG. 65C the delivery instrument 6802 is retracted
away from the labrum L and a tissue piercing needle 6806 is then
deployed from the delivery instrument 6802. The delivery instrument
6802 is advanced distally so that needle 6806 pierces and passes
through the labrum, pulling a portion of the suture with it as seen
in FIG. 65D. A pusher rod 6808 is then advanced distally from the
delivery instrument 6802 so as to push the needle 6806 into a
central channel of the anchor 6804 where the two lock together, as
shown in FIG. 65E. The delivery instrument 6802 is then retraced
away from the labrum L. A free end 6810 of the suture S is also
pulled away from the labrum L, as illustrated in FIG. 65F. In FIG.
65G, the delivery instrument 6802 is removed from the surgical
field and in FIG. 65H, the free end 6810 is pulled by the surgeon
in order to adjust length and tension in the suture which captures
the labrum L. The excess suture is then severed and removed. This
process may be repeated along the length of the torn labrum.
[0164] A number of the suture anchor systems described above use
two anchors placed end-to-end in the bone. In some cases it may be
preferable to place only a single anchor into the bone. The
exemplary embodiment of FIG. 66 illustrates a single anchor
embodiment. Suture S is pre-threaded in an anchor 4802 which may
include a cinching mechanism 4804, such as any of those disclosed
herein. Suture S forms a loop 4808 which is first passed around the
labrum L or through a penetration therein so that the end of the
loop is exposed on the opposite side of the labrum. Suture anchor
4802 is then passed through the interior of the exposed end of the
loop thereby completely capturing the labrum. Anchor 4802 is then
inserted directly into the acetabulum A or into a hole pre-drilled
into the bone. The free end 4806 of the suture exits the anchor
4802 and may be pulled to adjust the length or tension in the
suture.
[0165] Another exemplary embodiment of a suture anchor system using
only a single anchor is illustrated in FIG. 67. This embodiment is
similar to that of FIG. 66 except that anchor 4902 has two one-way
cinching mechanisms to allow either end 4904 or end 4906 of suture
S to be adjustably tensioned. The labral tissue is captured and the
anchor placed in the manner described above in connection with FIG.
66.
[0166] FIG. 68 shows another exemplary embodiment of a suture
anchor system requiring only a single anchor. In this embodiment,
one end of a suture S has a pre-formed loop 5002 that is first
inserted through or passed around the labrum L. Anchor 5006 is then
passed through the loop 5002 and inserted into the acetabulum by
driving it into the bone or placing it in a pre-drilled hole. The
suture passes through a one-way cinching mechanism (not shown) in
anchor 5006 and a free end 5004 exits the anchor. The cinching
mechanism may be any of those described in this specification. The
free end 5004 may be pulled in order to adjust length or tension in
the suture.
[0167] FIG. 69 illustrates still another exemplary embodiment of a
suture anchor system with a single anchor. One end of a suture S is
attached to the anchor 5102 with a knot 5104 or other coupling
mechanism. The other end 5110 passes through a cinching mechanism
in the anchor, which may be any of those disclosed herein, forming
a closed loop 5112. In this embodiment, the loop 5112 may be passed
through the labrum using a specialized loop passing tool, shown in
FIGS. 70A-70B. In FIG. 70A, loop 5112 of the suture S may be
coupled to a passing tool 5202 having a pointed tip 5204. The tool
may be used to pierce the labrum with a single, or two holes 5106,
5108, and pass the loop 5112 therethrough. Loop 5112 is then
released from passing tool 5202. FIG. 70B illustrates a needle 5206
coupled to loop 5112 of the suture S. The needle may be passed
through the labrum along with the suture. Needle 5206 may then be
removed from loop 5112. Once loop 5112 is passed through labrum L,
the anchor is passed through the loop and driven into the bone or
inserted in a predrilled hole in the bone. The free end 5110 may
then be pulled in order to adjust suture length or tension. FIG. 69
further illustrates an alternative approach for capturing the
labrum in which the suture is passed through the exposed edge 5114
of the labrum L which has been torn or cut from the acetabulum,
rather than through the anterior face of the labrum. With this
positioning of the suture, the labrum may be drawn directly into
engagement with the acetabular rim with improved circumferential
alignment between the labrum and acetabulum. Further, the sutures
are exposed only on the outer side of the labrum so that there is
no risk of engagement between the sutures and the femoral head as
it moves.
[0168] FIG. 71 illustrates another exemplary embodiment of a suture
anchor system utilizing only a single anchor. This embodiment is
substantially similar to the embodiment illustrated in FIG. 67
above with each end 5304, 5306 of suture S in its own cinching
mechanism in anchor 5302. However, in this embodiment, each
cinching mechanism comprises a pair of apertures 5308a, 5308b in
the outer wall of the anchor through which the suture is threaded,
like that illustrated in FIG. 46. After passing the loop 5310
through the labrum L, passing the anchor through the loop, and
deploying the anchor in the acetabulum, each of the free ends 5304,
5306 may be pulled in order to adjust suture length or tension.
[0169] Several exemplary methods of deploying suture anchors into
tissue have been described above. However, this is not meant to be
limiting. Other methods of deploying the anchor and re-attaching
the damaged tissue to the substrate tissue may be used, such as
those disclosed in U.S. Provisional Patent Applications and U.S.
Patent Applications previously incorporated herein by references.
Moreover, various other features such as anchor tip configurations,
anchor coupling mechanisms, tissue capturing methods and suture
cinching mechanisms have also been disclosed above and in
references incorporated herein. One of skill in the art will
appreciate that these features may be combined with one another or
substituted for another and thus any number of combinations may be
used.
[0170] While the above detailed description and figures are a
complete description of the preferred embodiments of the invention,
various alternatives, modifications, and equivalents may be used.
The various features of the embodiments disclosed herein may be
combined or substituted with one another. Therefore, the above
description should not be taken as limiting in scope of the
invention which is defined by the appended claims.
* * * * *