U.S. patent application number 12/776177 was filed with the patent office on 2010-11-18 for methods and devices to treat diseased or injured musculoskeletal tissue.
This patent application is currently assigned to Foundry Newco Xl, Inc.. Invention is credited to Stephen Boyd, Mark Deem, Hanson S. Gifford, III, Darin C. Gittings, Michael Hendricksen, Vivek Shenoy.
Application Number | 20100292731 12/776177 |
Document ID | / |
Family ID | 43069138 |
Filed Date | 2010-11-18 |
United States Patent
Application |
20100292731 |
Kind Code |
A1 |
Gittings; Darin C. ; et
al. |
November 18, 2010 |
METHODS AND DEVICES TO TREAT DISEASED OR INJURED MUSCULOSKELETAL
TISSUE
Abstract
A knotless suture anchoring system includes an outer anchor
having a central channel and a distal tip adapted to penetrate
tissue. An inner anchor is positionable in the central channel of
the outer anchor and a locking feature on one or both of the inner
and outer anchors retains the inner anchor within the central
channel. A continuous length of suture is coupled with the inner
and outer suture anchors and has a free end. At least one of the
inner and the outer anchors also has a cinching mechanism that
allows the suture to be tensioned by passage of the suture through
the cinching mechanism in a first direction while movement of the
suture through the cinching mechanism in a second direction
opposite the first direction is constrained.
Inventors: |
Gittings; Darin C.;
(Sunnyvale, CA) ; Deem; Mark; (Mountain View,
CA) ; Hendricksen; Michael; (Redwood City, CA)
; Shenoy; Vivek; (Redwood City, CA) ; Gifford,
III; Hanson S.; (Woodside, CA) ; Boyd; Stephen;
(Murrieta, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER, EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
Foundry Newco Xl, Inc.
Menlo Park
CA
|
Family ID: |
43069138 |
Appl. No.: |
12/776177 |
Filed: |
May 7, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61177602 |
May 12, 2009 |
|
|
|
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0496 20130101;
A61B 2017/0448 20130101; A61B 2017/00867 20130101; A61B 2017/0462
20130101; A61B 17/0466 20130101; A61B 2017/0422 20130101; A61B
2017/0446 20130101; A61B 2017/0417 20130101; A61B 2017/0429
20130101; A61B 2017/045 20130101; A61B 2017/0414 20130101; A61B
2017/0454 20130101; A61B 2017/0409 20130101; A61B 2017/0451
20130101; A61B 17/0401 20130101; A61B 2017/044 20130101; A61B
2017/0459 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A knotless suture anchoring system comprising: an outer anchor
having a central channel and a distal tip adapted to penetrate
tissue; an inner anchor positionable in the central channel of the
outer anchor; a locking feature on one or both of the inner and
outer anchors configured to retain the inner anchor within the
central channel; and a continuous length of suture coupled with the
inner and outer anchors, the suture having a free end, wherein at
least one of the inner and outer anchors further comprises a
cinching mechanism adapted to allow the suture to be tensioned by
passage of the suture through the cinching mechanism in a first
direction while movement of the suture through the cinching
mechanism in a second direction opposite the first direction is
constrained.
2. The anchoring system of claim 1, wherein the central channel
extends only partially through the outer anchor.
3. The anchoring system of claim 1, wherein the locking feature
comprises an annular recessed region in the central channel of the
outer anchor.
4. The anchoring system of claim 1, wherein the outer anchor
comprises an outer surface having surface features adapted to
anchor the outer anchor with the tissue or to promote tissue
ingrowth.
5. The anchoring system of claim 1, wherein the locking feature
comprises a plurality of resilient fingers extending radially
outward from the inner anchor.
6. The anchoring system of claim 1, wherein the cinching mechanism
comprises a deflectable arm coupled to either the inner or the
outer anchor.
7. The anchoring system of claim 1, wherein the cinching mechanism
is operative regardless of the position of the inner anchor
relative to the outer anchor.
8. The anchoring system of claim 1, further comprising a delivery
instrument having a longitudinal axis, wherein the delivery
instrument is adapted to carry both the inner anchor and the outer
anchor simultaneously.
9. The anchoring system of claim 8, wherein the delivery instrument
is configured to receive a drill, wherein the drill is adapted to
create an aperture in the tissue sized to receive the inner or the
outer anchor.
10. The anchoring system of claim 1, wherein the central channel is
disposed at an angle transverse to a longitudinal axis of the outer
anchor such that the inner anchor is disposed at an angle
transverse to the longitudinal axis of the outer anchor when
received in the central channel.
11. A knotless suture anchoring system comprising: an outer anchor
having a central channel and a distal tip adapted to penetrate
tissue; an inner anchor positionable in the central channel of the
outer anchor and having a distal tip adapted to penetrate and be
retained in tissue outside the outer anchor whereby the inner
anchor may be positioned either in the outer anchor or in tissue
apart from the outer anchor; a locking feature on one or both of
the inner and outer anchors configured to retain the inner anchor
within the central channel; and a continuous length of suture
coupled with the inner and outer anchors, the suture having a free
end, wherein at least one of the inner and outer anchors further
comprises a clamping mechanism adapted to clamp the suture under
tension without knotting the suture.
12. The anchoring system of claim 11, wherein the central channel
extends only partially through the outer anchor.
13. The anchoring system of claim 11, wherein the locking feature
comprises an annular recessed region in the central channel of the
outer anchor.
14. The anchoring system of claim 11, wherein the outer anchor
comprises an outer surface having surface features adapted to
anchor the outer anchor with the tissue or to promote tissue
ingrowth.
15. The anchoring system of claim 11, wherein the inner anchor
locking feature comprises a plurality of resilient fingers
extending radially outward from the inner anchor.
16. The anchoring system of claim 11, wherein the clamping
mechanism comprises a cinching mechanism adapted to allow the
suture to be tensioned by passage of the suture through the
cinching mechanism in a first direction while movement of the
suture through the cinching mechanism in a second direction
opposite the first direction is constrained.
17. The anchoring system of claim 16, wherein the cinching
mechanism comprises a deflectable arm coupled to either the inner
or the outer anchor.
18. The anchoring system of claim 16, wherein the cinching
mechanism is operative regardless of the position of the inner
anchor relative to the outer anchor.
19. The anchoring system of claim 17, wherein the deflectable arm
is integral with either the inner or the outer anchor.
20. The anchoring system of claim 17, wherein the deflectable arm
is disposed in an aperture within either the inner or the outer
anchor.
21. The anchoring system of claim 20, wherein the aperture is in an
axial channel extending at least partially through the inner
anchor.
22. The anchoring system of claim 21, wherein the arm moves in a
first radial direction when the suture is pulled in the first
direction and the arm moves in a second radial direction when the
suture is pulled in the second direction.
23. The anchoring system of claim 22, wherein the suture is clamped
between the arm and a wall of the aperture when the suture is
pulled in the second direction.
24. The anchoring system of claim 22, wherein the arm is resilient
so as to return to an unbiased position after moving in either the
first or the second radial directions.
25. The anchoring system of claim 22, wherein the arm deflects
radially inward when the suture is pulled in the second direction
to clamp the suture between the arm and an opposing wall of the
aperture, thereby constraining movement of the suture in the second
direction.
26. The anchoring system of claim 11, further comprising a delivery
instrument having a longitudinal axis, wherein the delivery
instrument is adapted to carry both the inner anchor and the outer
anchor simultaneously.
27. The anchoring system of claim 26, wherein the delivery
instrument has an axial lumen, the inner and the outer anchors
being releasably carried in the axial lumen.
28. The anchoring system of claim 26, wherein the delivery
instrument comprises a steering mechanism adapted to deflect a
distal portion of the instrument.
29. The anchoring system of claim 26, wherein the delivery
instrument comprises a suture management feature, said feature
adapted to releasably hold the length of suture and prevent
tangling thereof.
30. The anchoring system of claim 11, wherein the delivery
instrument is configured to receive a drill, wherein the drill is
adapted to create an aperture in the tissue sized to receive the
inner or the outer anchor.
31. The anchoring system of claim 26, wherein the delivery
instrument is adapted to deliver the inner anchor and the outer
anchor at an angle transverse to the longitudinal axis of the
delivery instrument.
32. The anchoring system of claim 31, wherein the delivery
instrument comprises a hammer element coupled with the delivery
instrument and adapted to convert axial movement along the
longitudinal axis of the delivery instrument into an impacting
force transverse to the longitudinal axis of the delivery
instrument.
33. The anchoring system of claim 26, wherein each of the inner and
the outer anchors have a longitudinal axis and the delivery
instrument carries the inner and the outer anchors such that the
longitudinal axis of both anchors is transverse to the longitudinal
axis of the delivery instrument.
34. The anchoring system of claim 11, wherein the central channel
is disposed at an angle transverse to a longitudinal axis of the
outer anchor such that the inner anchor is disposed at an angle
transverse to the longitudinal axis of the outer anchor when
received in the central channel.
35. The anchoring system of claim 26, wherein the delivery
instrument comprises a jaw having first opposable member pivotably
coupled with a second opposable member, wherein the first opposable
member carries the inner anchor and the second opposable member
carries the outer anchor, and wherein actuation of the jaw inserts
the inner anchor into the outer anchor.
36. The anchoring system of claim 35, wherein the inner and the
outer anchors each have a longitudinal axis and wherein the anchors
are carried by the opposable members such that the longitudinal
axis of the anchors are transverse to a longitudinal axis of the
opposable members.
37. A knotless suture anchoring system comprising: a first anchor
having a housing with a central channel sized to receive a suture
therein; and a cinching mechanism having a radially deflectable arm
integral with the housing and disposed at least partially in the
central channel, the suture passing through an opening in the arm
and passing between a free end of the arm and the housing, wherein
the cinching mechanism is adapted to allow the suture to pass
through the cinching mechanism in a first direction while movement
of the suture through the cinching mechanism in a second direction
opposite the first direction is constrained.
38. The anchoring system of claim 37, wherein the cinching
mechanism comprises a deflectable arm coupled to the first
anchor.
39. The anchoring system of claim 38, wherein the deflectable arm
is integral with the first anchor.
40. The anchoring system of claim 38, wherein the deflectable arm
is disposed in an aperture within the first anchor.
41. The anchoring system of claim 40, wherein the aperture is in an
axial channel extending at least partially through the first
anchor.
42. The anchoring system of claim 41, wherein the arm moves in a
first radial direction when the suture is pulled in the first
direction and the arm moves in a second radial direction when the
suture is pulled in the second direction.
43. The anchoring system of claim 42, wherein the suture is clamped
between the arm and a wall of the aperture when the suture is
pulled in the second direction.
44. The anchoring system of claim 42, wherein the arm is resilient
so as to return to an unbiased position after moving in either the
first or the second radial directions.
45. The anchoring system of claim 42, wherein the arm deflects
radially inward when the suture is pulled in the second direction
to clamp the suture between the arm and an opposing wall of the
aperture, thereby constraining movement of the suture in the second
direction.
46. The anchoring system of claim 37, wherein the housing comprises
a distal tip adapted to penetrate tissue.
47. The anchoring system of claim 46, wherein the housing comprises
an outer surface having surface features adapted to anchor the
first anchor in the tissue or to promote tissue ingrowth.
48. The anchoring system of claim 37, further comprising a second
anchor having an inner channel configured to receive the first
anchor, wherein the inner channel comprises a locking feature
adapted to engage with the first anchor to retain the first anchor
in the second anchor.
49. A knotless suture anchoring system comprising: a pin having a
distal tip adapted to penetrate tissue; an anchoring bracket; and a
length of suture, wherein the suture is adapted to be coupled to
the pin and the bracket.
50. The anchoring system of claim 49, wherein the bracket is
L-shaped.
51. The anchoring system of claim 49, wherein the bracket comprises
a suture management feature adapted to receive and hold the
suture.
52. The anchoring system of claim 51, wherein the suture management
feature comprises a slit in the bracket.
53. The anchoring system of claim 49, wherein the bracket comprises
an anchoring pin adapted to penetrate the tissue thereby fixing the
bracket to the tissue.
54. The anchoring system of claim 49, wherein the suture is formed
into a loop sized to capture tissue to be repaired.
55. The anchoring system of claim 54, wherein the tissue to be
repaired comprises a torn labrum.
56. The anchoring system of claim 49, wherein the anchoring bracket
or the pin further comprise a cinching mechanism adapted to allow
the suture to be tensioned by passage of the suture through the
cinching mechanism in a first direction while movement of the
suture through the cinching mechanism in a second direction
opposite the first direction is constrained.
57. A knotless suture anchoring system comprising: a delivery
instrument having a longitudinal axis, a shaft axially movable
along the longitudinal axis, and a hammer adapted to convert axial
movement along the longitudinal axis into movement transverse
thereto; and a first anchor carried by the delivery instrument and
having a distal tip adapted to penetrate tissue, wherein axial
movement of the slidable shaft along the longitudinal axis moves
the hammer in a motion transverse thereto, thereby impacting the
anchor, whereby the first anchor is driven into the tissue at an
angle transverse to the longitudinal axis of the delivery
instrument.
58. A method of knotless suturing comprising: providing a delivery
instrument carrying a first anchor and a second anchor, wherein a
continuous length of suture is coupled with the first and the
second anchors; advancing the delivery instrument to a treatment
region comprising treatment tissue; placing the first anchor into a
first region of the tissue; coupling the suture to a portion of the
treatment tissue; attaching the second anchor to the first anchor;
tensioning the suture; and securing the suture without knotting the
suture by moving the suture through a cinching mechanism in the
first or the second anchor, wherein the cinching mechanism is
adapted to allow the suture to move through the cinching mechanism
in a first direction while movement of the suture through the
cinching mechanism in a second direction opposite the first
direction is constrained independently of the position of the
second anchor relative to the first anchor.
59. The method of claim 58, wherein the second anchor is stationary
relative to the first anchor during the entire step of securing the
suture.
60. The method of claim 58, wherein the tissue comprises bone and
the step of placing the first anchor or the step of placing the
second anchor comprises drilling a pilot hole into the bone, the
pilot hole sized to receive the first or the second anchor.
61. The method of claim 58, further comprising deflecting a distal
portion of the delivery instrument.
62. The method of claim 58, wherein the first region of tissue
comprises the acetabulum and the treatment tissue comprises an
acetabular labrum.
63. The method of claim 58, wherein the step of attaching the
second anchor to the first anchor comprises inserting the second
anchor into a central channel of the first anchor and locking the
two anchors together to prevent axial movement of the first anchor
relative to the second anchor.
64. The method of claim 58, wherein the delivery instrument further
comprises an actuator mechanism near a proximal end of the
instrument and the step of placing the first anchor or the step of
placing the second anchor comprises actuating the actuator
mechanism to expose the first or the second anchor from the
delivery instrument.
65. The method of claim 58, wherein the step of securing comprises
clamping the suture between a deflectable arm and an inner wall of
the first or the second anchor.
66. The method of claim 65, wherein the arm is integral with either
the first or the second anchor.
67. The method of claim 58, wherein the step of attaching comprises
placing the second anchor in a central channel within the first
anchor.
68. The method of claim 67, wherein the cinching mechanism is
disposed in an inner channel of the second anchor.
69. The method of claim 58, wherein the delivery instrument has a
longitudinal axis, and wherein the step of placing the first anchor
comprises placing the first anchor into the first region at an
angle transverse to the longitudinal axis of the delivery
instrument.
70. The method of claim 58, wherein the step of attaching the
second anchor to the first anchor comprises actuating a jaw
disposed on the delivery instrument.
71. A method of knotless suturing comprising: providing an
anchoring device having an anchoring bracket, a length of suture
and a pin, wherein the suture is coupled to the bracket and the
pin; anchoring the bracket to a first tissue region; capturing
tissue to be treated with the suture; securing the pin to a
structure selected from the bracket and a second tissue region; and
tensioning the suture.
72. The method of claim 71, wherein the step of anchoring the
anchoring bracket comprises inserting a pin coupled to the
anchoring bracket into the first region.
73. The method of claim 71, wherein the step of capturing the
tissue to be treated comprises looping the suture around said
tissue.
74. The method of claim 71, wherein the step of tensioning the
suture comprises passing the suture through a cinching mechanism in
the pin or in the anchoring bracket, wherein the cinching mechanism
is adapted to allow the suture to pass through the cinching
mechanism in a first direction while movement of the suture through
the cinching mechanism in a second direction opposite the first
direction is constrained.
75. The method of claim 71, wherein tensioning the suture comprises
securing the suture without knotting the suture.
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 No. 61/177,602
(Attorney Docket No. 028357-000110US, formerly 020979-003910US),
filed May 12, 2009, the entire contents of which are incorporate
herein by reference.
[0002] The present application is related to U.S. patent
application Ser. No. 12/605,065 (Attorney Docket No.
028357-000120US, formerly 020979-003920US), filed Oct. 23, 2009,
the entire contents of which 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 or tendons 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 become
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 preattached), tension is adjusted, and then
the suture is knotted so that the tissue is secured in a desired
position. Frequently two or more anchors and multiple lengths of
suture are required. This process 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. 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.
[0007] 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 can be too large. Thus, it would be desirable to
provide suture anchors that have a small diameter and length.
[0008] Additionally, in most surgical procedures, a pilot hole is
drilled at the implantation site prior to screwing in the suture
anchor. In other cases a self-tapping device tip is used to screw
in the device without a pilot hole. Alternatively, ultrasonic
energy has been proposed in embedding bone anchors in bony tissue
without pre-drilling a pilot hole. These methods of implanting a
device in bone tissue, while commonly used in surgery today, are
not optimal. Pre-drilling a pilot hole prior to placing the device
requires the surgeon to exchange tools through the cannula and to
locate the pilot hole after introducing the implant in the
arthroscopic field. Self-tapping devices are limited to use at
sites with the appropriate thickness of cortical bone. Ultrasonic
energy based devices are susceptible to large energy losses with
minor changes in device configuration, and rely on ultrasonic
energy sources which can be expensive. Therefore, there is a need
for improved devices, systems and methods which overcome some of
the aforementioned challenges.
[0009] In addition, current arthroscopic devices are limited in
that they generally approach a surgical site in a longitudinal
manner. If it is necessary to implant a bone anchor at an angle,
which is often the case, the current devices do not fully address
the need for an off axis approach. Furthermore, there is a need for
anchors to be compatible with a device that implants the anchors at
an angle off of the longitudinal axis of the shaft of the driving
device. At least some of these objectives will be met by the
inventions described hereinbelow.
[0010] 2. Description of the Background Art
[0011] Patents disclosing suture anchoring devices and related
technologies include U.S. Pat. Nos. 7,390,329; 7,309,337;
7,144,415; 7,083,638; 6,986,781; 6,855,157; 6,770,076; 6,656,183;
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
[0012] 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.
[0013] In a first aspect of the present invention a knotless suture
anchoring system comprises an outer anchor having a central channel
and a distal tip adapted to penetrate tissue and an inner anchor
positionable in the central channel of the outer anchor. The system
also includes a locking feature on one or both of the inner and
outer anchors and that is configured to retain the inner anchor
within the central channel. A continuous length of suture is
coupled with the inner and outer anchors and the suture has a free
end. At least one of the inner and outer anchors further comprises
a cinching mechanism that is adapted to allow the suture to be
tensioned by passage of the suture through the cinching mechanism
in a first direction while movement of the suture through the
cinching mechanism in a second direction opposite the first
direction is constrained.
[0014] In another aspect of the present invention, a knotless
suture anchoring system comprises an outer anchor having a central
channel and a distal tip adapted to penetrate tissue. An inner
anchor is positionable in the central channel of the outer anchor
and has a distal tip that is adapted to penetrate and be retained
in tissue outside the outer anchor whereby the inner anchor may be
positioned either in the outer anchor or in tissue apart from the
outer anchor. The system also includes a locking feature on one or
both of the inner and outer anchors that is configured to retain
the inner anchor within the central channel and a continuous length
of suture coupled with the inner and outer anchors. The suture has
a free end. At least one of the inner and outer anchors further
comprises a clamping mechanism adapted to clamp the suture under
tension without knotting the suture.
[0015] Sometimes the central channel extends only partially through
the outer anchor and the locking feature may comprise an annular
recessed region in the central channel of the outer anchor. The
outer anchor may comprise an outer surface having surface features
that are adapted to anchor the outer anchor with the tissue or to
promote tissue ingrowth.
[0016] The inner anchor locking feature may comprise a plurality of
resilient fingers extending radially outward from the inner anchor.
The clamping mechanism may comprise a cinching mechanism adapted to
allow the suture to be tensioned by passage of the suture through
the cinching mechanism in a first direction while movement of the
suture through the cinching mechanism in a second direction
opposite the first direction is constrained. The cinching mechanism
may comprise a deflectable arm coupled to either the inner or the
outer anchor. Additionally, the cinching mechanism often may be
operative regardless of the position of the inner anchor relative
to the outer anchor. The deflectable arm may be integral with
either the inner or the outer anchor and the deflectable arm may be
disposed in an aperture within either the inner or the outer
anchor. The aperture may be in an axial channel extending at least
partially through the inner anchor. The deflectable arm may move in
a first radial direction when the suture is pulled in the first
direction and the arm may move in a second radial direction when
the suture is pulled in the second direction. The suture may be
clamped between the arm and a wall of the aperture when the suture
is pulled in the second direction. The arm may be resilient so as
to return to an unbiased position after moving in either the first
or the second radial directions. The arm may deflect radially
inward when the suture is pulled in the second direction to clamp
the suture between the arm and an opposing wall of the aperture,
thereby constraining movement of the suture in the second
direction.
[0017] The system may also comprise a delivery instrument having a
longitudinal axis, and the delivery instrument may be adapted to
carry both the inner anchor and the outer anchor simultaneously.
The delivery instrument often may have an axial lumen, the inner
and the outer anchors being releasably carried in the axial lumen.
The delivery instrument may comprise a steering mechanism that is
adapted to deflect a distal portion of the instrument. Also the
delivery instrument may comprise a suture management feature that
is adapted to releasably hold the length of suture and prevent
tangling thereof. In some embodiments, the delivery instrument may
be configured to receive a drill which is adapted to create an
aperture in the tissue sized to receive the inner or the outer
anchor. In still other embodiments, the delivery instrument may be
adapted to deliver the inner anchor and the outer anchor at an
angle transverse to the longitudinal axis of the delivery
instrument. The delivery instrument may have a hammer element that
is coupled with the delivery instrument and that is adapted to
convert axial movement along the longitudinal axis of the delivery
instrument into an impacting force transverse to the longitudinal
axis of the delivery instrument. Each of the inner and the outer
anchors have a longitudinal axis and the delivery instrument may
carry the inner and the outer anchors such that the longitudinal
axis of both anchors is transverse to the longitudinal axis of the
delivery instrument.
[0018] The central channel of the outer anchor may be disposed at
an angle transverse to a longitudinal axis of the outer anchor.
Thus, the inner anchor may be disposed at an angle transverse to
the longitudinal axis of the outer anchor when received in the
central channel.
[0019] The delivery instrument may comprise a jaw having first
opposable member pivotably coupled with a second opposable member.
The first opposable member may carry the inner anchor and the
second opposable member may carry the outer anchor, and actuation
of the jaw may insert the inner anchor into the outer anchor. The
inner and the outer anchors may each have a longitudinal axis and
the anchors may be carried by the opposable members such that the
longitudinal axis of the anchors are transverse to a longitudinal
axis of the opposable members.
[0020] In still another aspect of the present invention, a knotless
suture anchoring system comprises a first anchor having a housing
with a central channel sized to receive a suture therein. The
system also has a cinching mechanism with a radially deflectable
arm integral with the housing and disposed at least partially in
the central channel. The suture passes through an opening in the
arm and passes between a free end of the arm and the housing. The
cinching mechanism is adapted to allow the suture to pass through
the cinching mechanism in a first direction while movement of the
suture through the cinching mechanism in a second direction
opposite the first direction is constrained.
[0021] The cinching mechanism may comprise a deflectable arm
coupled to the first anchor. The deflectable arm may be integral
with the first anchor and it may be disposed in an aperture within
the first anchor. The aperture may be in an axial channel extending
at least partially through the first anchor. The arm may move in a
first radial direction when the suture is pulled in the first
direction and the arm may move in a second radial direction when
the suture is pulled in the second direction. The suture may be
clamped between the arm and a wall of the aperture when the suture
is pulled in the second direction. The arm may be resilient so as
to return to an unbiased position after moving in either the first
or the second radial directions. The arm may deflect radially
inward when the suture is pulled in the second direction to clamp
the suture between the arm and an opposing wall of the aperture,
thereby constraining movement of the suture in the second
direction.
[0022] The housing may comprise a distal tip adapted to penetrate
tissue. The housing may also comprise an outer surface having
surface features adapted to anchor the first anchor in the tissue
or to promote tissue ingrowth. The system may also include a second
anchor having an inner channel configured to receive the first
anchor. The inner channel may comprise a locking feature adapted to
engage with the first anchor to retain the first anchor in the
second anchor.
[0023] In yet another embodiment of the present invention, a
knotless suture anchoring system may comprise a pin having a distal
tip adapted to penetrate tissue, an anchoring bracket and a length
of suture. The suture is adapted to be coupled to the pin and the
bracket. The bracket may be L-shaped and may comprise a suture
management feature adapted to receive and hold the suture. The
suture management feature may comprise a slit in the bracket. The
bracket may also have an anchoring pin that is adapted to penetrate
the tissue thereby fixing the bracket to the tissue. The suture may
be formed into a loop sized to capture tissue to be repaired and
the tissue to be repaired may comprise a torn labrum. The anchoring
bracket or the pin may further comprise a cinching mechanism
adapted to allow the suture to be tensioned by passage of the
suture through the cinching mechanism in a first direction while
movement of the suture through the cinching mechanism in a second
direction opposite the first direction is constrained.
[0024] In another aspect of the present invention, a knotless
suture anchoring system comprises a delivery instrument having a
longitudinal axis, a shaft axially movable along the longitudinal
axis, and a hammer adapted to convert axial movement along the
longitudinal axis into movement transverse thereto. A first anchor
is carried by the delivery instrument and has a distal tip adapted
to penetrate tissue. Axial movement of the slidable shaft along the
longitudinal axis moves the hammer in a motion transverse thereto,
thereby impacting the anchor, whereby the first anchor is driven
into the tissue at an angle transverse to the longitudinal axis of
the delivery instrument.
[0025] In still another aspect of the present invention, a method
of knotless suturing comprises providing a delivery instrument
carrying a first anchor and a second anchor, wherein a continuous
length of suture is coupled with the first and the second anchors.
The delivery instrument is advanced to a treatment region
comprising treatment tissue and the first anchor is placed into a
first region of the tissue. The suture is coupled to a portion of
the treatment tissue and the second anchor is attached to the first
anchor. The suture is tensioned and secured without knotting the
suture. The suture is secured by moving the suture through a
cinching mechanism in the first or the second anchor, wherein the
cinching mechanism is adapted to allow the suture to move through
the cinching mechanism in a first direction while movement of the
suture through the cinching mechanism in a second direction
opposite the first direction is constrained independently of the
position of the second anchor relative to the first anchor.
[0026] The second anchor may be stationary relative to the first
anchor during the entire step of securing the suture. The tissue
may comprise bone and the step of placing the first anchor or the
step of placing the second anchor may comprise drilling a pilot
hole into the bone. The pilot hole may be sized to receive the
first or the second anchor. The method may further comprise
deflecting a distal portion of the delivery instrument. The first
region of tissue may comprise the acetabulum and the treatment
tissue may comprise an acetabular labrum.
[0027] The step of attaching the second anchor to the first anchor
may comprise inserting the second anchor into a central channel of
the first anchor and locking the two anchors together to prevent
axial movement of the first anchor relative to the second anchor.
The delivery instrument may further comprise an actuator mechanism
near a proximal end of the instrument and the step of placing the
first anchor or the step of placing the second anchor comprises
actuating the actuator mechanism to expose the first or the second
anchor from the delivery instrument. The step of securing may
comprise clamping the suture between a deflectable arm and an inner
wall of the first or the second anchor. The arm may be integral
with either the first or the second anchor.
[0028] The step of attaching may comprise placing the second anchor
in a central channel within the first anchor. The cinching
mechanism may be disposed in an inner channel of the second anchor.
The delivery instrument has a longitudinal axis, and the step of
placing the first anchor may comprise placing the first anchor into
the first region at an angle transverse to the longitudinal axis of
the delivery instrument. The step of attaching the second anchor to
the first anchor may comprise actuating a jaw disposed on the
delivery instrument.
[0029] In another aspect of the present invention, a method of
knotless suturing comprises providing an anchoring device having an
anchoring bracket, a length of suture and a pin, wherein the suture
is coupled to the bracket and the pin. The bracket is anchored to a
first tissue region and tissue to be treated is captured with the
suture. The pin is secured to a structure selected from the bracket
and a second tissue region and the suture is tensioned.
[0030] The step of anchoring the bracket may comprise inserting a
pin coupled to the anchoring bracket into the first region. The
step of capturing the tissue to be treated may comprise looping the
suture around said tissue. The step of tensioning the suture may
comprise passing the suture through a cinching mechanism in the pin
or in the anchoring bracket. The cinching mechanism is adapted to
allow the suture to pass through the cinching mechanism in a first
direction while movement of the suture through the cinching
mechanism in a second direction opposite the first direction is
constrained. Tensioning the suture may comprise securing the suture
without knotting the suture.
[0031] These and other embodiments are described in further detail
in the following description related to the appended drawing
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0032] FIG. 1 illustrates anatomy of the hip joint.
[0033] FIG. 2 is a top view of the hip joint.
[0034] FIG. 3 illustrates a torn labrum in a hip joint.
[0035] FIG. 4 illustrates reattachment of a labrum in a hip
joint.
[0036] FIGS. 5A-5C illustrate use of a suture anchor in an
acetabular rim.
[0037] FIG. 6 is a sectional view of an anchor loaded in the distal
end of an anchor driver and placed through a shaft.
[0038] FIGS. 7A-7E show an exemplary embodiment of a device that
drives two anchors.
[0039] FIGS. 8A-8C illustrate an exemplary embodiment of a device
that drives two anchors through a single conduit.
[0040] FIG. 9A shows a malleable anchor.
[0041] FIG. 9B is a sectional view showing the delivery of a
malleable anchor.
[0042] FIGS. 10A-10B show a multiple anchor system.
[0043] FIGS. 11A-11D show anchors with suture tensioning
capabilities.
[0044] FIGS. 12A-12C show devices for temporary attachment of
tissue to bone.
[0045] FIGS. 13A-13B show an anchor and suture tensioning
system.
[0046] FIGS. 14A-14C show an anchor and suture tensioning and
locking system.
[0047] FIGS. 15A-15D show a suture wedge lock system for securing
sutures in an anchor system.
[0048] FIGS. 16A-16G show a suture locking anchor.
[0049] FIGS. 17A-17B show a suture locking mechanism.
[0050] FIG. 18 shows an additional suture locking mechanism.
[0051] FIGS. 19A-19B show an additional suture locking
mechanism.
[0052] FIG. 20A shows an exemplary embodiment of a suture
anchor.
[0053] FIG. 20B illustrates a suture locking mechanism.
[0054] FIG. 20C illustrates another embodiment of a suture anchor
and locking mechanism.
[0055] FIG. 21 shows a right angle driver for driving bone
anchors.
[0056] FIG. 22 shows an angled driver for driving bone anchors.
[0057] FIGS. 23A-23B show an eccentrically mounted impact driver
for driving bone anchors.
[0058] FIG. 24 shows an inertia equalizing driver for driving bone
anchors.
[0059] FIG. 25A-25B show alternative embodiments of a pressure
driven impactor for driving bone anchors.
[0060] FIGS. 26A-26O illustrate an exemplary embodiment of a suture
anchor system having a cinching mechanism.
[0061] FIGS. 27A-27D illustrate another embodiment of a suture
anchor system.
[0062] FIGS. 28A-28C illustrate still another embodiment of a
suture anchor system.
[0063] FIGS. 29A-29E illustrate yet another embodiment of a suture
anchor system.
[0064] FIG. 30 illustrates an embodiment of a suture anchor having
two sutures.
[0065] FIG. 31 illustrates an embodiment of a suture anchor that
accommodates a pilot hole drill.
[0066] FIGS. 32A-32C illustrate another embodiment of a suture
anchor system.
[0067] FIG. 33 illustrates another embodiment of a suture anchor
system.
DETAILED DESCRIPTION OF THE INVENTION
[0068] 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 areas of the body including joints such as the shoulder
joint, the ankle, wrist and other joints may also be treated. 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.
[0069] 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 3002. Surgeons
typically use suture and suture anchors to reattach the labrum to
the acetabular rim. FIG. 4 illustrates how a suture anchor 3102 is
used to anchor suture 3104 to the acetabular rim A. The suture 3104
is looped around and captures the torn labrum 3002 holding it
against the bone until it heals and reattaches. The suture is
either pre-attached to the anchor, or it is attached during the
repair procedure. Suture length and tension is then adjusted to
ensure apposition of the damaged tissue with the substrate tissue.
Suture anchors are typically used instead of screws, pins, rivets
or other fasteners due to the limited working space within the
joint.
[0070] 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 into the acetabular rim 3206 to repair
the labrum L, the anchor width or diameter 3204 cannot exceed the
width 3202 of the acetabular rim 3206. Moreover, as shown in FIGS.
5A-5B, the anchor width 3204 must be small enough relative to the
width of the acetabular rim 3206 so that adequate purchase is
obtained without comprising strength of the rim 3206. Additionally,
length of the anchor can also be critical. In FIG. 5B, the anchor
3204 is placed orthogonally into the acetabular rim and thus 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 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 short enough to
avoid penetration into the articular surface, preferably being at
least about 5 mm and less than about 14 mm in length.
[0071] Referring now to FIG. 6, an arthroscopic delivery instrument
may be used to deliver an implantable device, here a suture anchor,
to a desired anchor site. FIG. 6 shows a cross-sectional view of a
delivery instrument 103 having an tubular outer shaft 105 that is
sized for endoscopic delivery into a joint space, such as the hip,
shoulder, ankle, wrist, or other joint. A common cannula used in
arthroscopy has an inner diameter of approximately 5.5 mm and
therefore the outer shaft 105 should have a diameter small enough
to freely move in the cannula, thus outer shaft 105 is preferably
about 5.4 mm in diameter or less. Additionally, the shaft 105 is
long enough to extend into the treatment region such as a joint
space and thus is preferably at least about 16.5 cm (6.5 inches)
long. These dimensions may be applied to any of the delivery
instruments disclosed below.
[0072] The shaft 105 carries an inner impactor 102 and a suture
anchor 101 is releasably coupled with the impactor. The suture
anchor 101 has a pointed or sharpened distal tip in order to allow
it to penetrate bone 104 or other tissue. Once the suture anchor
101 has been delivered to a desired anchor site, the proximal end
of the impactor 102 may be hit with a hammer or other object in
order to drive the anchor 101 into the bone 104. Alternatively, the
impactor may be energized with other forms of energy, such as
ultrasonic energy or other types of oscillating or vibrating energy
in order to drive the anchor 101 into the bone 104. The impactor
may drive the implant into bone at frequencies between 10 and 20
kHz, preferably between 20 and 1000 Hz, more preferably between 30
and 500 Hz. The amplitude at which the impactor is energized may be
at amplitudes of 100 to 1000 microns, preferably 200 to 750
microns, more preferably 300-500 microns. A suture (not
illustrated) may be attached to the anchor 101 by tying the suture
to aperture 106, or the suture may be attached using other
techniques well known in the art including crimping or bonding.
[0073] The embodiment of FIG. 6 allows a single suture anchor to be
deployed at a time. In some situations, it may be desirable to
deploy multiple suture anchors simultaneously. The exemplary
embodiment of FIGS. 7A-7E show the distal end of an endoscopic
delivery instrument 200 that drives two anchors 201a and 201b into
tissue independently or simultaneously. Any suture anchor disclosed
herein may be used, and other anchors disclosed in U.S. patent
application Ser. No. 12/605,065 (Attorney Docket No.
028357-000120US, formerly 020979-003920US), filed Oct. 23, 2009,
may also be used, the entire contents of which are incorporated
herein by reference. In the exemplary embodiment of FIG. 7A, the
endoscopic (or arthroscopic, or laparoscopic, etc.) device performs
several functions. It comprises two arms 204a and 204b, each of
which holds an anchor 201a, 201b, with a suture (see FIG. 7D) or
other connective material (see FIG. 7E) connecting the proximal
ends of the two anchors. Once the device is in position, the arms
capture the tissue T to be repaired and the anchors are driven
through the tissue into the desired bone B using impact drivers 205
operably coupled with the arms 204a, 204b. The impact driver 205 is
shown moving at a right angle or perpendicular to the arms, however
it could also move translationally along the long axis of the
grasper, or the anchor itself could be curved. This device is
intended to be introduced through a cannula or small incision. To
enable the device to pass through a cannula or small incision and
still have an appropriate separation between the two anchors, the
device may be fabricated so that the arms can be laterally
separated, for example by hinging them apart. Such a device would
be introduced through the cannula with the arms close together, to
reduce the overall width of the device. Then, once the device has
been introduced into the body to the surgical site, the arms are
separated from each other, tensioning the suture between the
anchors. The anchors can then be driven into the tissue by closing
the arms around the tissue, and then the anchors may be driven into
the bone B either by direct hammering or by impacting the anchors
using impact drivers 205 as described above. FIG. 7B illustrates
the arms capturing the tissue T to be repaired. In FIG. 7B, the
arms 204a, 204b may comprise teeth or other surface features that
allow the tissue T to be more securely grasped. FIG. 7C illustrates
the arms closed around the tissue T with an anchor 201a or 201b
passing through the tissue T and being secured to the bone. FIG. 7D
illustrates an end view of FIG. 7C, showing the tissue T grasped
between the arms 204a, 204b and the anchors 201a, 201b penetrating
the tissue T about to penetrate the bone B. A suture 203 extends
between the two anchors 201a, 201b. By having an anchor with a
cinchable/tensionable suture, the suture tension between the
anchors may be adjusted. FIG. 7E shows as alternate to having a
suture connect the anchors. A connective member 206 is constructed
that spans the gap between the two anchors and distributes the
force generated by the anchors to the tissue T. This member may be
flexible so that the two halves of the grasper are movable with
respect to one another. Multiple sets of anchors could be placed
depending on the size of the repair.
[0074] There are numerous variations and elaborations on this
approach, which may provide added benefits and enhance their
applicability to a range of different clinical settings. For
instance, each arm might additionally have a grasper near the end
of each arm, which is configured to expand and grasp tissue (e.g.
the rotator cuff). While holding the tissue, the device can then be
repositioned (for example, repositioning the device over the
humeral head to apply the appropriate tension to the rotator cuff).
Then the anchor can be driven through this tissue into another
tissue (such as the bone of the humeral head) to anchor the tissue.
The grasper is then released. The grasper and arm may also have
appropriate slots to allow the instrument to be removed while
leaving the anchors in place with a tight suture connecting them,
approximating the tissue to the bone with just the right amount of
tension to allow rapid healing of the cuff to the bone.
[0075] The anchors may be driven parallel to the axis of the arms,
or at a right angle to the axis of the instrument, or at a lesser
angle depending on the angle necessary to drive into tissue and
bone. For instance, a more linear arrangement may work well for
labral reattachment in the shoulder and the hip, and a more
right-angled arrangement might work better for reattaching the
rotator cuff. The end configuration of the instrument may have the
ability to articulate or be actively steered, to facilitate anchor
placement while conforming to the various anatomies.
[0076] As described above, the suture between the two anchors might
be appropriately tensioned simply by adjusting the initial
separation of the jaws, and/or by the action of driving the anchors
into the tissue. However, this system could also be combined with
an anchor that has a suture lock mechanism so that the suture can
be discretely tensioned after the anchor has been placed. This
feature might be particularly useful in a knotless rotator cuff
repair system. It might alternatively be preferable to have
separate sutures on each of the anchors, which could then be tied
together after the anchors are placed. Several embodiments of a
suture locking mechanism are disclosed below and they may be
combined with any of the anchor embodiments disclosed herein.
[0077] The distance between the anchors may be adjustable depending
on the anatomy and amount of repair necessary. The distance can be
varied through the grasper controls. One or more sets of anchors
may be loaded on the device in a magazine fashion such that the
anchors are loaded in a tubular magazine and advanced through the
grasper. This would facilitate a complete tissue repair procedure
without removing the instrument from the patient.
[0078] FIG. 8A illustrates another embodiment of a device for
driving multiple anchors through a single conduit. This embodiment
includes a delivery instrument 300 that is adapted to drive
multiple anchors 301a, 301b through channel 302 of conduit 303. The
means of driving one or more anchors is separate from grasping
tissue. FIG. 8A shows a cross section of the instrument with two
anchors. A suture having ends 304a, 304b extends from each of the
anchors. The sutures are preferably pre-connected to the two
anchors, although they may be connected during the surgical
procedure. The conduit 303 has two distinct lumens 305a, 305b which
are used to carry the anchors. A relief between the lumens allows
for the passage of the suture from one anchor to the other if
necessary. The two lumens 305a, 305b may be separate tubes
contained within an external tube that holds all of the elements
and allows passage of the device through a cannula for use in
arthroscopic or mini-open procedures, such as rotator cuff repair
or labral repair in the hip. The lumens and external tube may be
steel or a high strength polymer or a combination of materials. The
lumens may be round or rectangular in cross section depending on
the cross section of the anchors. Impactors, or drivers 306a, 306b
for the anchors are shown and may be independently or
simultaneously driven from a pneumatic or mechanical driver body
(not shown).
[0079] This embodiment is useful for positioning multiple anchors
simultaneously that are connected by suture or other means. The
instrument may be used to re-attach the labrum in the shoulder or
the hip or for other procedures. To accomplish this, a pair of
anchors is positioned adjacent to one another and driven through
the labrum into the bone below. A connection means between the
anchors provides positive fixation of the labrum to the bony tissue
below. The tissue grasper features of the previous embodiment may
also be used with this embodiment. Thus, all of the features and
permutations described previously for tissue attachment may be
applied to this embodiment as well.
[0080] FIGS. 8B-8C illustrate how a multiple anchor system loaded
with sutures may be used. In this embodiment instrument 300 is
first used to place a first pair of anchors 307a, 307b through
tissue T into underlying bone B. Sutures are fixed to anchors at
positions 307a and 307b. Instrument 300 is then used to place
anchors 308a, 308b into bone B adjacent tissue T. The suture ends
attached to anchors 308a, 308b are then tied to sutures attached to
anchors 307a, 307b. There may be one or more sutures attached to
each of the anchors such that a crisscross pattern may be produced
which creates good apposition of tissue T to bone B.
[0081] In another embodiment shown in FIGS. 9A-9B, a malleable,
flexible, or shapeable anchor is disclosed. Multiple anchors 400
may be loaded into a main channel 407 of delivery instrument 402 in
a stacked relationship. A proximal land 405 on the anchor 400
engages a flexible internal driving member to drive the anchor into
bone. A suture S or other connection means is fixed to anchor 400
within anchor channel 401. An axial passage 403 in delivery
instrument 402 receives each length of suture S attached to anchors
400. As the anchor is driven out of the rigid sheath into bony
tissue the anchor changes from a curved to a straightened
configuration due to the malleable or flexible nature of the anchor
material. The anchor may alternatively be made from discrete
sections that separate around the bend of the delivery tube and
then interlock as they exit the straight portion. In an exemplary
embodiment the anchor consists of rigid portions that are connected
by articulating elements along the anchor. In another embodiment
the anchor is constructed of a shape memory material and is
forcibly restrained in a curved configuration prior to deployment
of the anchor. One of skill in the art will appreciate that it is
not necessary for the anchor to return to or assume a strictly
straight shape. In still other embodiments, the anchors are fit
together similar to pencil lead cartridges and driven together as a
train. Individual anchors are deployed as they exit the instrument.
FIG. 9B illustrates deployment of the anchor 400. The anchors curve
around from position A to exit at B. The anchors may exit as
straight or may maintain a curve depending on the application and
the bore at exit B.
[0082] In another embodiment, anchor systems are disclosed which
deliver multiple anchors with proper suture tensioning and locking
capabilities. FIG. 10A shows an anchor system 500 with a bone
anchor 501 that accepts a smaller anchor 502 passed through tissue
for use e.g. in rotator cuff or labral repair in the shoulder or
hip. The larger bone anchor has a hole 503 in it to receive the
smaller anchor. The hole that accepts the smaller anchor 502 may be
along the longitudinal axis of the anchor 501 or at an oblique or
right angle (transverse to the longitudinal axis), depending on the
desired configuration for the applicable procedure. A suture 504
connects the two anchors.
[0083] FIG. 10B shows the system with the main anchor in the bone B
and the smaller anchor placed through an angled hole in the main
anchor. The smaller anchor has been advanced through the tissue T
and is small enough to be pushed through tissue much like a needle
so as to avoid damaging the tissue. The smaller anchor is then
placed in the larger anchor. In this figure the two are shown
implanted into bone at an oblique angle relative to each other,
thereby optimizing purchase in the bony tissue. A suture 504 is
connected between the two anchors. The suture is then tensioned
appropriately to provide approximation of the tissue to the bone.
Once the appropriate tension in the suture has been achieved the
smaller anchor 502 is moved to a final position within the larger
anchor 501, and the suture is locked into position by clamping the
suture between the two anchors. Other knotless cinching mechanisms
may be used in either anchor as described below. Locking of smaller
anchor 502 within larger anchor 501 may be achieved with detent
mechanisms, a press fit or other means known in the art.
[0084] Another embodiment for anchors placed with suture tensioning
capabilities is shown in FIGS. 11A-11B. This design has a fixed
anchor with a slidable component that locks the suture in place
after tensioning appropriately. Anchor 601 has a moveable member
602 that slides into a recess 604 in anchor 601 to lock a suture
603 in place after proper tension is achieved. FIG. 11A shows the
mechanism in the unlocked position and in FIG. 11B the mechanism is
locked. Moving the sliding component downward into recess 604
wedges the suture between the sliding component and the body of the
anchor thereby locking the suture into position.
[0085] FIG. 11C shows an anchor system 650 where multiple anchors
601 are loaded on a suture with the initial anchor in the string
having a fixed suture. As the anchors are placed the suture is
tensioned and locked. FIG. 11D shows a rotator cuff RC or other
tissue being secured using this series of anchors. A series of
anchors is placed as shown and a suture runs through all of the
anchors. Once the anchors have been placed appropriately the suture
may be locked one by one as the surgeon adjusts tension in the
suture.
[0086] In another embodiment shown in FIGS. 12A-12C, a device for
temporary attachment of tissue to bone allows for locating and
holding tissue, such as the rotator cuff, while permanent anchors
are placed. This may be necessary for determining how much tension
should be applied to the tissue or the amount of tissue to be
positioned by the suture prior to permanent placement.
[0087] FIGS. 12A-12C show a temporary anchor 701. The temporary
anchor may be extremely small, less than 1.5 mm, so that a more
permanent anchor of 1.5 mm or greater may be placed in the same
hole as the temporary anchor or adjacent the temporary anchor. The
temporary anchor may have a flange or tab 704 that extends outside
the bone so that it can be easily removed using a set of graspers
or hook and then the permanent anchor placed. The temporary anchor
includes a pre-loaded suture 702 that runs freely through a
U-shaped passage 705 in the anchor, and a removable stake 703 that
slides through an axial channel 706 to engage suture 702 in passage
705 to secure the suture in place after appropriate tensioning.
FIGS. 12A and 12B show a simple suture and stake placement. FIG.
12C shows a cross section of the device with the stake compressing
and securing the suture in place. The stake may be a press fit into
the anchor body or housing, compressing or wedging the suture
against the body, or the stake may have ribbed features to create a
locking means against the suture and shell. After forcing the stake
into the body, the exposed end of the stake also may be used to
remove the assembly from the bone.
[0088] In another embodiment, FIG. 13A and FIG. 13B show an anchor
and suture tensioning system 800 for approximating tissue. FIG. 13A
shows an anchor system that is driven through tissue (such as the
rotator cuff) into the underlying bone. The device also has a
suture 803 attached with the small pad 802 attached to the end of
the suture. In this embodiment the anchor 801 is placed through
tissue T into bone B with a large surface area pad 802 remaining on
the tissue attached to a tensioning suture 803. The small pad
resides on the top of the cuff of tissue while the suture pulls the
pad down towards the anchor, compressing the tissue against the
bone. FIG. 13B shows a representation of this embodiment where the
anchor is shown embedded in bone B and the suture extends through
the tissue T to the pad positioned on the surface of the cuff. This
system may also comprise a suture tensioning/locking, clamping, or
cinching mechanism, such as those disclosed hereinbelow. The suture
tensioning element could be located in either the anchor or in the
pad.
[0089] FIGS. 14A-14C illustrate a penetrating bone anchor 900 with
suture tensioning and locking capability. Anchor 900 has an outer
tubular member 908 which receives a penetrating anchor member 903.
Referring to FIG. 14A, a pair of radially deflectable fingers 901
which are illustrated deformed radially inward 902, are integrally
attached to outer tubular member 908. In FIG. 14B the penetrating
anchor member 903 is shown having a stem 904 with a hole 905 to
accept a suture 906 or wire. FIG. 14C is a cross section of the
assembly showing a suture 906 loaded through the anchor member. As
a driver 907 is forced down into the outer member 908, the driver
deforms the fingers 901 inward to clamp the suture between the
fingers 901 and the anchor stem 904, thereby preventing suture
movement and maintaining adequate suture tension.
[0090] In another embodiment a suture wedge lock system has an
additional function for locking the anchor under the cortical shelf
within a cancellous region of bone, such as in the head of the
humerus. FIG. 15A shows a penetrating anchor 1001 and an outer
member 1002 with deformable cutouts 1003. The cutouts have holes
1004 to accept a suture or wire 1005 shown in FIG. 15B. FIG. 15C
shows a wedge-like member 1006 with the ability to wedge itself
into the outer member 1002 as shown in FIG. 15D. In FIG. 15D the
wedge 1006 locks the suture in place against the cutouts 1003 and
because of the bulbous shape of the lateral edges 1007 of the wedge
1006, the deformable cutouts 1003 move radially outward so that
their proximal ends 1009 extend beyond the outer wall of the
anchor. This locks the suture in position, and also helps secure
the anchor to the bone. When this anchor system is placed below the
cortical shell of a bone and within the cancellous region of the
bone, the cutouts 1003 engage the cortical shell, preventing the
anchor from pulling out of the bone.
[0091] FIGS. 16A-11G illustrate a suture anchor having a locking
mechanism for securing the suture. In this embodiment, the suture
anchor has an inner member 1101 with a tapered shaft 1102 having a
through hole 1103 transverse to the shaft's longitudinal axis. The
through hole is sized to accept a length of suture 1104. The suture
may be pre-loaded or it may be loaded during a surgical procedure
using a wire or other means to thread the suture through the hole
1103. In use, the suture 1104 is threaded through a donut shaped
member 1105 that is welded or otherwise attached to the outer
member 1106 of the assembly (removed for clarity in FIG. 16C). When
the anchor is placed, the operator will tension the suture
appropriately, and then lock the suture in place by advancing a
pusher tube against the donut, breaking the weld or other
attachment. As the pusher tube continues to be advanced, the donut
is forced further toward the tip of the anchor and the suture
becomes locked between the tapered shaft 1102 of the inner member
1101 and the donut 1105. FIG. 16A shows the anchor system 1100
loaded into a delivery device. FIG. 16B shows the anchor 1101 with
a tapered shaft 1102 and a central hole 1103 through which the
suture 1104 passes. FIG. 16C shows a donut 1105 being placed over
the tapered shaft of the anchor. The suture runs between the donut
and the tapered shaft. FIG. 16D shows the outer anchor body 1106
placed over the donut and the tapered anchor 1101. Wings 1107 on
the outer member 1106 protrude radially outward, and may be forced
outward as the donut 1105 is advanced along the tapered anchor
shaft 1103. The wings may be used to help engage the anchor with
the cortical shell of bone, as described above. The donut 1105 is
welded by heat, adhesives or the like to the outer anchor body
1106.
[0092] FIGS. 16E through FIG. 16G show a cross section of the final
assembly and the operation of the delivery instrument. FIG. 16E
illustrates a cross section of the delivery instrument used to
place the suture anchor, often in bone. An external shaft 1108
holds the anchor 1101 and a driver tube 1109 may be advanced
against the donut. The suture runs through the cutout 1110 (FIG.
16A) on the external shaft 1108. When the suture is tensioned
appropriately, the internal driver tube 1109 will force donut 1105
distally, breaking the weld as shown in FIG. 16F and capturing and
locking the suture as the donut locks on the shaft as shown in FIG.
16G.
[0093] FIGS. 17A-17B illustrate another embodiment of a suture
anchor having a suture locking mechanism. FIG. 17A is a perspective
view of the suture anchor and FIG. 17B shows a cross section of the
locking mechanism. In this embodiment, the locking mechanism uses a
floating suture locking mechanism within the anchor body. The
suture 1203, 1204 is threaded through the floating locking bar 1202
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 main body
of the anchor 1201 is configured to receive a sliding locking bar
1202. As tension on the suture thread end 1203 is increased the
sliding member is pulled proximally locking the suture in position.
When tension is exerted on thread end 1204 the system remains free
to move and the suture slides. The floating member 1202 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 could become locked as the material compresses around it
during tensioning. In addition, the floating lock could be molded
with a variety of surface features to cause a more secure lock,
similar to a cleat found on sailboats.
[0094] FIG. 18 illustrates still another embodiment of a suture
anchor with locking mechanism, shown in cross section. In FIG. 18,
an outer tube 1301 contains a fixed element 1302 with a pair of
holes 1305, 1311 and an axially slidable member 1303 with a pair of
holes 1307, 1313 that lock against the fixed member when one end of
a suture 1304 is tensioned. Because hole 1305 in the fixed element
1302 is radially offset from hole 1307 in sliding member 1303, a
portion of suture 1309 is trapped between the fixed element and
slidable member when suture end 1304 is tensioned, locking the
suture. If the opposite end of the suture is pulled, because hole
1311 is axially aligned with hole 1313, the suture will slide
through the slidable member and fixed element without trapping the
portion of suture 1309 against the fixed element. In some
embodiments, the slidable member 1303 may also be positioned on a
helix-like track so that more positive locking occurs as the
slidable member moves axially and rotationally along the tube
axis.
[0095] FIGS. 19A-19B illustrate another embodiment of a suture
anchor having a locking mechanism. Suture anchor 1400 includes a
ball 1404 that is axially movable within a tubular body 1408 and
captured by a swaged head 1401. Suture 1402, 1403 is wrapped under
the ball and the ball 1404 allows the suture to move in the
direction of suture end 1403, while locking the suture when pulled
in the direction of suture end 1402. When suture end 1402 is
pulled, the ball is pulled up against the swaged end 1401 trapping
the suture between ball 1404 and body 1408 and preventing further
movement. When the opposite suture end 1403 is pulled, a cutout
1406 in the sidewall of body 1408 near swaged end 1401 allows the
suture to be advanced without pinching it between the ball and the
swaged end of the anchor, thus the suture may be tensioned. A
groove in the ball may be provided to maintain the suture position
relative to the cutout 1406.
[0096] FIGS. 20A-20B illustrate an alternative embodiment with a
core 1500 with a flange 1501 on its proximal end. Core 1500 is
positionable in an anchor sleeve 1502 adapted to be driven into
bone or tissue. Core 1500 may have a friction fit in sleeve 1502 or
a locking mechanism may be provided to retain the core 1500 in
sleeve 1502. Additionally, the flanged region 1501 may be used to
help drive the anchor 1502 into the bone. Core 1500 and sleeve 1502
may be driven in to bone together, or sleeve 1502 may be driven in
first separately. FIG. 20B illustrates securing the suture to the
anchor. The ends of suture 1503 extend through a central channel
1504 of the anchor sleeve and then pass through apertures 1506,
1508 in the sidewall of the anchor sleeve such that the suture
forms an outer loop around the outer surface of the anchor sleeve
1502. Suture 1503 is locked by being trapped between the proximal
end of sleeve 1502 and core 1500 when the core 1500 is pressed
distally into central channel 1504. FIG. 20C illustrates an
alternative embodiment of a suture anchor having an inner core
1522, and outer anchor sleeve 1520 and suture 1526 Inner core 1522
has a pointed distal tip 1532 that can penetrate bone and a flanged
region 1524 and apertures 1534, 1536. Outer sleeve 1520 also has a
pointed distal tip 1530 that is adapted to penetrate bone. The
inner core 1522 is sized to fit in the outer core 1520. Either the
inner core 1522 or the outer sleeve 1520 may be driven into bone
individually or simultaneously. Flange 1524 provides a shoulder
which may be used to help drive the outer sleeve 1520 into the
bone. A locking mechanism (e.g. detents, press fit, snap fit, etc.)
may be used to lock the inner core 1522 with the outer sleeve 1520.
The suture 1526 is secured to the inner core 1522 by passing
through a central channel 1528 in the inner core 1522 and then
exiting the inner core through apertures 1534, 1536 in the wall of
the inner core 1522. The suture 1526 then is partially looped
around the outer surface of inner core 1522. When the inner core
1522 and the outer sleeve 1520 are locked together, the suture 1526
will be trapped between the flange 1524 and the proximal end of the
outer sleeve 1520, securing it in position.
[0097] Any of the embodiments disclosed herein my also be used for
drug delivery. The suture and/or the suture anchor may be coated
with or carry a therapeutic agent that can be released in a
controlled manner. For example, the therapeutic agent may be time
released and eluted into the bone or affected tissue in order to
enhance healing. Multiple medicaments may be impregnated into or
coated onto the anchors in a similar fashion as stents. Examples of
coatings that produce a sustained-release are those made by
SurModics Corporation and Angiotech. Examples of medicaments that
could be eluted are anti-inflammatory medicaments, NSAIDs
(non-steroidal anti-inflammatories), and hyaluronic acid. Stem
cells or other bone or cell growth promoters may also be used in
such coatings.
[0098] Some of the suture anchors may be fabricated from durable
metals such as stainless steel, titanium or nitinol. Alternatively,
a variety of polymers may be used. It would also be desirable to
provide anchors that bioerode away after some period of time. Thus,
any of the embodiments disclosed herein may be fabricated from
bioerodable polymeric materials. Combinations of durable metals or
polymers and bioerodable polymers may also be used and similarly
bioerodable sutures and durable sutures may also be used. In an
exemplary embodiment, a bioerodable anchor may be loaded onto a
delivery core made from stainless steel or titanium. The anchor is
driven into the bone and then the core is removed, leaving the
anchor permanently implanted. The anchor has a suture attached and
can be tensioned using any of the locking mechanisms described
herein. The anchor may be fabricated from polymers such as PEEK or
PMMA and polymers that are well known for bioerosion include PGA,
PLGA, and PLA.
[0099] FIGS. 21-22, 23A-23B, 24, and 25A-25B schematically
illustrate several exemplary embodiments of instruments for
delivering the suture anchor and driving the anchor into tissue
such as bone. The anchors delivered using such instruments may be
any of the embodiments illustrated herein or other commercially
available anchors. FIG. 21 illustrates an embodiment with a low
profile right angle driver for driving one or more suture anchors
into bone. The need for a right angle driver occurs when the angle
of attack for placing an anchor arthoscopically prohibits a
straight approach as is often the case with labral repair in the
hip. In FIG. 21, an anchor 1601 is held at a perpendicular angle
relative to the longitudinal axis of the delivery instrument 1604.
A hammer or striker 1602 pivotably connected to the instrument
shaft 1604 is used to transfer energy to anchor 1601 from an
axially movable impacting member 1603 that can be driven manually
or by a pneumatic or hydraulic cylinder or other known means. This
embodiment may be used to drive a single anchor or it may be easily
adapted to include multiple strikers so that two or more anchors
may be driven individually or simultaneously into the bone. In
order to reduce profile of the instrument, when driving multiple
anchors the instrument preferably has a hinge or other articulation
that allows the two drivers to move closer together for access and
then spread apart within the body prior to impaction of the
anchors. While a 90 degree driver is shown, various other angles
transverse to the longitudinal axis of the delivery instrument 1604
are also possible.
[0100] FIG. 22 illustrates another embodiment of an angled anchor
driver. In this embodiment the distal end 1704 of the hammer or
impacting member 1701 is angled to form a wedge that impacts
striker 1702, which has the corresponding angle on its proximal end
1706 to interface with impacting member 1701. Thus, as impact
member 1701 moves axially, it drives the striker 1702 down at a
right angle to impact member 1701 and into anchor 1703. In the
embodiments of FIGS. 21-22, the instrument is adapted to drive an
anchor into bone or other tissue at a 90 degree angle relative to
the longitudinal axis of the delivery instrument. One of skill in
the art will of course appreciate that this angle may be varied
depending on the anatomy. Thus in still other embodiments, the
distal region of the delivery instrument may be articulated so that
the delivery angle can be varied. In still other embodiments,
interchangeable tips may be used having predetermined angles
ranging from 0 degrees to 90 degrees. Still other embodiments may
have actively steerable tips that may be controlled from the
proximal end of the device outside of the patient.
[0101] FIGS. 23A-23B illustrate still another embodiment of a
delivery instrument 1800. FIG. 23A shows a front view of a rotating
shaft 1801 that is operably coupled with a head 1802. The head is
eccentrically attached to the rotating shaft 1801. Thus, as the
shaft 1801 rotates and spins the head 1802, the head contacts a
driver 1803 that moves linearly in a direction transverse to shaft
1801 to impact an anchor 1804. The driver may be spring loaded or
may simply be forced back after impacting the anchor to the
original position for the next impact from the mass. The instrument
1800 will usually include an outer housing or tubular shaft
(removed for clarity) enclosing shaft 1801 and operatively coupled
to driver 1803 and anchor 1804.
[0102] FIG. 24 schematically illustrates a pneumatically driven
impactor. One advantage of this embodiment over conventional
pneumatically driven tools is that it has much lower vibration as
compared with standard air tools. The impactor contains two pistons
1901 and 1902 that move axially in opposite directions as air is
introduced into the chamber 1903. The pistons move at equal
velocities in opposite directions. Piston 1901 drives the anchor
1906 via a driver 1904 while the piston 1902 simultaneously impacts
the opposite end of the chamber, thereby providing a counter force
to the force required to drive in the anchor. After impact the
pistons are pushed by springs (not shown) or vacuum back to the
center of the chamber 1903 and the process is repeated. Dampening
springs or materials may be placed at one or both ends of the
chamber to further decrease excessive or extraneous vibrations. In
addition, size, weight, or materials of the pistons may be the same
or different depending on the amount of vibration that must be
eliminated. In preferred embodiments, the pistons are identical,
however, different driving forces may necessitate different masses
as well as different dampening materials. Pistons of different
masses traveling at different distances and different speeds may be
used to dampen each other as well. Any of these pneumatic
embodiments may be operated at different frequencies for different
applications, e.g., hip labrum repair versus rotator cuff repair in
the shoulder. In addition, this dual piston driver arrangement may
be used in the right angle instruments disclosed elsewhere
herein.
[0103] FIG. 25A illustrates another pressure driven impactor. FIG.
25A is a cross section of the impactor device 2000, which may be
actuated using high pressure gas such as nitrogen. The gas flows
through a channel 2001 contained within shaft 2002 shown as
P.sub.in in FIG. 25A. The pressure in channel 2001 moves a driver
2003 pivotably coupled to shaft 2002 to impact the anchor 2004 at
an angle transverse to shaft 2002. When driver 2003 travels the
full distance, it moves past an exhaust orifice 2007 and gas is
exhausted through P.sub.out. Torsion spring 2005 forces the driver
2003 back to the initial position. By varying the dimensions of the
driver, the velocity of the driver can change creating different
forces on the anchor. Additional porting and/or use of vacuum can
create different frequencies and dampening within the driver
chamber which would eliminate the need for or enhance the spring
function. FIG. 25B is a cross section of an alternative gas
pressure-driven embodiment in which a linearly movable driver 2008
transverse to shaft 2002 is used instead of pivotable driver 2003.
A compression spring 2006 is used to return the driver 2008 to the
original position.
[0104] FIGS. 26A-26O illustrate another embodiment of a knotless
suture anchor delivery system used to attach tissue to bone,
especially useful for reattaching a torn labrum to the acetabulum.
FIG. 26A illustrates a perspective view of an anchor delivery
system 2100 which includes a suture anchor 2104 having an inner and
outer anchor carried in a distal portion of outer shaft 2102.
[0105] Still referring to FIG. 26A, the suture may be carried
inside the shaft or outside of the shaft and is not illustrated in
this view. Outer shaft 2102 is sized to fit in an arthroscopic
cannula for delivery through a portal into a joint space. Thus, as
discussed above with respect to FIG. 6, the outer shaft preferably
has a diameter of 5.4 mm or less so that it may easily fit in a
typical arthroscopic cannula having an inner diameter of
approximately 5.5 mm. Additionally, the working length of the outer
shaft 2102 preferably is long enough to extend into a treatment
region such as the acetabular socket and is preferably at least
about 16.5 cm (6.5 inches) long. These dimensions may be applied to
any of the delivery instruments disclosed in this specification
when adapted for use in arthroscopic treatment of the hip. The
proximal portion of the outer shaft 2102 includes a handle 2106
having an actuator mechanism 2108, 2110 for controlling the
delivery system during various stages of anchor deployment.
[0106] FIG. 26B illustrates the inner 2122 and outer 2124 suture
anchors in greater detail. Suture S is attached to outer anchor
2124 in a manner described more fully below. The suture is sized to
be large enough to minimize the possibility of pulling through or
tearing tissue and small enough to be secured to the inner and
outer suture anchors. The suture then enters a central channel 2129
in inner anchor 2122 and is wrapped around a cinching mechanism
2135 and then a free end F exits the inner anchor. The cinching
mechanism includes a radially deflectable arm 2134 that is integral
with the inner suture anchor 2122. The arm 2134 has a hole 2136 to
allow the suture to pass through the arm so that the suture is
disposed on either side of the arm. Additional details on the
suture anchor are disclosed below.
[0107] FIG. 26C is a cross sectional exploded view of a distal
portion of the delivery instrument 2100 and anchor 2104
illustrating the inner shaft 2114, the intermediate shaft 2112 and
the outer shaft 2102 of the delivery system as well as the inner
anchor 2122 and the outer anchor 2124. The outer anchor 2124 has a
tapered distal point 2116 adapted for penetrating bone. Outer
anchor 2124 further includes a central channel 2126 for receiving
the inner anchor 2122 and an annular recess 2128 acts as a locking
mechanism for locking the inner anchor 2122 in the channel 2126.
Resilient deflectable fingers or arms 2130 extend radially outward
from the inner anchor and lock into the annular recess 2128. Other
features such as slot 2132, and bore holes or channels 2120, 2121
are described in greater detail below.
[0108] FIG. 26D shows a cross section of the proximal region of the
delivery system. In FIG. 26D, an inner shaft 2114 and an
intermediate shaft 2112 are slidably disposed in outer shaft 2102.
Handle 2106 includes a distal knob 2108 that is threadably engaged
with the handle body 2106 and also operably coupled with outer
shaft 2102. Thus, rotation of knob 2108 relative to the handle body
2106 will either advance or retract outer shaft 2102 relative to
the inner shaft 2114 and the intermediate shaft 2112. Handle 2106
also includes a proximal knob 2110 that is threadably engaged with
the handle body 2106 and also operably coupled with the inner shaft
2114. Rotation of knob 2110 relative to handle body 2106 will
either advance or retract inner shaft 2114 relative to the
intermediate shaft 2112 or the outer shaft 2108. One of skill in
the art will appreciate that motion is relative, therefore either
knob may be rotated relative to the handle or the handle may be
rotated relative to a knob. Moreover, it will also be appreciated
that other actuator mechanism known to those skilled in the art may
be substituted for the rotating knobs, such as slider mechanisms or
levers. FIG. 26E illustrates another cross sectional view of the
proximal portion of the delivery system 2100 highlighting the
handle and actuator mechanism. In FIG. 26E, actuation of knob 2110
has retracted the inner shaft 2114 relative to the intermediate
shaft 2112 and the outer shaft 2102.
[0109] FIG. 26F illustrates a perspective view of a distal portion
of delivery system 2100. Normally, during delivery anchor 2104 is
enclosed entirely or almost entirely within shaft 2102 except with
its distal point 2116 exposed. Once the delivery instrument has
been advanced to a desired treatment site, the outer shaft 2102 is
retracted, exposing the suture anchor 2104. The distal end of the
anchor includes a tapered or pointed tip 2116 adapted to penetrate
tissue such as bone. An elongate slot 2118 near the distal end of
outer shaft 2102 allows the suture (not illustrated), which is
attached to anchor 2104 as described below, to exit the shaft 2102
without tangling. The anchors are deployed in a direction parallel
with the longitudinal axis of the delivery instrument. In some
embodiments, the delivery instrument may be flexible, bendable,
angled or articulated or it may be actively steerable in order to
deliver the anchors at angles transverse to the longitudinal axis
of the shaft 2102.
[0110] FIG. 26G illustrates a cross section of FIG. 26F and
highlights the suture anchor which includes an outer anchor 2124
and an inner anchor 2122 partially disposed in a central channel
2126 of the outer anchor 2124. Additionally, the outer anchor 2124
includes a longitudinal bore hole 2121 and a transverse bore 2120
in its wall 2123 through which a suture may pass to allow a suture
(not shown) to be fastened to the outer anchor. A plug may be used
to create an interference fit locking the suture into the bore
hole, or the suture may be bonded, tied, or otherwise fixed to the
outer anchor. In a preferred embodiment, the suture is knotted at
its end creating a ball that is larger than the longitudinal bore
diameter, thereby securing the suture to the anchor. The distal end
2125 of intermediate shaft 2112 engages the outer anchor 2124 while
the distal end of the inner shaft 2114 has a reduced diameter tip
2127 that fits within the central channel of inner anchor 2122.
[0111] FIG. 26H illustrates the outer anchor 2124 fully exposed
from the outer shaft 2102. Once exposed, the outer anchor 2124 may
be driven into the bone B or other tissue by exerting force on the
handle 2106 or using any of the techniques previously described.
Slot 2132 in intermediate shaft 2112 allows the suture (not shown),
which is coupled to the inner and outer anchors, to exit the shaft
2112 without tangling or binding with other components. After
deployment of outer anchor 2124 the inner anchor 2122 remains in
shaft 2102, separated from outer anchor 2124 with a suture (not
shown) coupled therebetween.
[0112] In some embodiments, the delivery instrument and anchors may
have a central channel that extends the entire length of the
device. This central channel is used to accommodate a drill bit or
other drilling device (e.g. water jet or laser) which can be used
to drill a pilot hole in the bone and facilitates placement of the
anchor into the bone. Thus, the system may further include a
drilling system such as a mechanical drill, a laser drill, water
jet drill or other drilling mechanisms for creating the pilot hole.
In some embodiments, the inner and intermediate shafts of the
delivery instrument along with anchor 2104 may be removed and
replaced with the drilling system and thus the outer shaft serves
as a guide for drilling. Once the pilot hole has been created,
keeping the outer shaft in place against the bone, the drill is
removed and the interior shafts and suture anchor are replaced in
the outer shaft to deliver the suture anchor into the drilled
hole.
[0113] In FIG. 26I, once the outer anchor 2124 has been driven into
bone B, the suture S may be looped around target tissue to be
captured (e.g. a torn labrum in the hip or shoulder joint) and the
inner anchor advanced relative to the outer shaft 2102. One end of
the suture S is attached to the outer anchor 2124 and another
portion of the suture is coupled with the inner anchor 2122 (as
described below). A free end F may be pulled to adjust the length
of suture between the inner and outer anchors, as well as allowing
adjustment of suture tension. The suture may run freely alongside
the outer shaft or in some embodiments the outer shaft may include
suture management features on its exterior such as grooves,
channels, eyelets, clips or other features which hold the suture
temporarily to keep the suture from tangling or knotting. In still
other embodiments, the suture may remain inside the outer shaft of
the delivery instrument and the suture may be threaded through one
or more lumens therein.
[0114] FIG. 26J illustrates the inner anchor 2122 fully exposed
from the outer shaft 2102. In this exemplary embodiment, the inner
anchor 2122 has a blunt distal end and is inserted into and locked
with outer anchor 2124. However, inner anchor 2122 may also have a
tapered or pointed tip similar to outer anchor 2124 thereby inner
anchor 2122 may be adapted to penetrate tissue such as bone or soft
tissue. Thus the inner anchor may be adapted to be driven directly
into bone at a location apart from the outer anchor.
Advantageously, in such embodiments, the operator has the option of
either coupling the inner anchor 2122 to the outer anchor 2124 or
driving the inner anchor into bone at another location prior to
cinching the suture to the appropriate level of tension.
[0115] FIG. 26K shows the inner anchor 2122 released from the inner
shaft 2114, although in use, the inner anchor 2122 would not be
detached from the inner shaft 2114 until it is either locked with
the outer anchor 2124 or driven into bone. FIG. 26L is a cross
section similar to that of FIG. 26C, except the inner, intermediate
and outer shafts 2102, 2112, 2114 have been shaded for ease of
viewing. FIG. 26M shows both the inner 2122 and the outer 2124
anchors released from the delivery instrument 2100 and the inner
anchor 2122 is locked in the central channel of the outer anchor
2124.
[0116] Referring back to FIG. 26B, the inner 2122 and outer 2124
suture anchors are illustrated in greater detail. Suture S is
attached to outer anchor 2124. The suture then enters a central
channel in inner anchor 2122 and is wrapped around the cinching
mechanism and then a free end F exits the inner anchor. The
cinching mechanism includes a radially deflectable arm 2134 that is
integral with the inner suture anchor 2122. The arm 2134 has a hole
2136 to allow the suture to pass through the arm so that the suture
is disposed on either side of the arm. Additionally, a plurality of
resilient fingers 2130 are disposed circumferentially around the
inner anchor and are adapted to snap into the annular recess 2128
in outer anchor 2124 (seen in FIG. 26N) to lock the inner and outer
anchors together. In some embodiments, the proximal end of the
central channel 2126 in outer anchor 2124 may be chamfered or have
a bevel to facilitate receipt of the inner anchor. The outer
diameter of the outer suture anchor is preferably less than 4 mm,
more preferably less than about 3.5 mm so that it is not
excessively large as compared to the area typically available on
the acetabular rim. Of course, other diameters may also be used
depending on where the anchor is to be placed. Additionally, the
length of the outer anchor is also sized so that it will not
penetrate through the acetabular rim into the articular surface of
the joint, preferably being at least about 5 mm and no more than
about 14 mm. The central channel is sized to receive the inner
anchor, which may be about 1-3 mm in diameter in exemplary
embodiments. These dimensions are extremely small and difficult to
machine thus it is only recently with the advent of laser cutting
and electrical discharge machining (EDM) as well as the
construction of each of the inner and outer anchors as a single
integral structure that such small components could be reliably
manufactured to acceptable engineering tolerances. Moreover, such
small scale components have not traditionally been used due to the
risk of failure in service, but is now possible due to better
biocompatible engineering materials and improved manufacturing
capabilities.
[0117] Outer anchor 2124 optionally may also have outer surface
features that help secure it to tissue such as bone. For example,
anchor 2124 may have wings similar to cutouts 1003 in FIGS. 15A-15D
or similar to the resilient deflectable arms 2130 on the inner
anchor, which help secure the anchor when placed below the cortical
shell of bone. The wings deflect radially inward as the anchor is
being placed into bone, and then the wings have sufficient
resilience to radially expand outward once the anchor is
positioned. In alternative embodiments, the wings may be forced
radially outward by engagement with the inner anchor as the inner
anchor is inserted into the outer anchor. In still other
embodiments, ribs, barbs, bumps, ridges, grooves, channels or other
surface features may also be machined or added to the outer surface
to help mechanically secure the anchor to bone or to promote tissue
ingrowth. The outer anchor is capable of resisting a pullout force
at least as large as the force required to tear tissue such as the
labrum. In preferred embodiments, the outer anchor pullout force
has a safety margin and thus it can resist a pullout force at least
1.5 times greater than the force required to tear tissue such as
the labrum. In exemplary embodiments the pull out force of the
anchor is about 20-80 lbs.
[0118] FIG. 26N is a cross section of FIG. 26B showing how the
cinching mechanism works. The suture S may be any commercially
available suture of suitable size and strength, either braided or
not, and may be free of knots, or other features to interact with
arm 2134 and be effectively clamped thereby. In FIG. 26N, suture is
attached to outer anchor 2124 by disposing the suture in bore holes
2121 and 2120. The suture may then be tied, bonded, plugged or
otherwise attached to the outer anchor within transverse hole 2120.
The suture extends into the central channel 2129 in inner anchor
2122 and around the distal end 2131 of deflectable arm 2134,
through aperture 2136 and the free end F exits the inner anchor. An
aperture 2140 in the sidewall of inner anchor 2122 creates an edge
2142 in the sidewall, the suture is pinched between arm 2134 and
the edge 2142 on the inner wall of the inner anchor. In some
embodiments, the distal end of arm 2134 may have a groove, a curved
tip or a forked tip to help keep the suture centered on the arm
2134. In embodiments having this feature, the aperture 2140 will be
fabricated to have a complementary shape to maintain a sharp edge
for pinching the suture against the grooved, curved or forked
region of the arm 2134.
[0119] Thus, once both anchors have been secured and the target
tissue captured by the suture, the free end F may be pulled through
the cinching mechanism. As the free end F of the suture is pulled,
the arm 2134 deflects outward (toward the sidewall of channel 2129
to which arm 2134 is attached), allowing the suture to pass through
the cinching mechanism without being constrained. On the other
hand, when the suture is pulled in the opposite direction, the
suture will deflect arm 2134 radially toward the opposite sidewall
of channel 2129, pinching the suture between the distal end 2131 of
arm 2134 and the inner wall of the inner anchor, locking the suture
in tension between the inner and outer anchors. Thus, the cinching
mechanism allows the suture to move through the inner anchor in one
direction without slipping in the opposite direction.
Advantageously, the suture is locked without need for the operator
to manually actuate a locking mechanism on the anchor. The cinching
mechanism is capable of holding the suture and resisting a pullout
force at least as large as the force required to tear tissue such
as the labrum. In preferred embodiments, the cinching mechanism has
a safety margin built into it and thus it can resist a suture
pullout force at least 1.5 times greater than the force required to
tear tissue such as the labrum. In exemplary embodiments, the
cinching mechanism 2135 in the inner anchor is preferably capable
of withstanding tension of 20-80 lbs on the suture S without
allowing the suture to slip.
[0120] It should be noted that the cinching mechanism may
alternatively be provided on the outer anchor 2124 with the suture
being fixed to the inner anchor 2122, or cinching mechanisms may be
provided on both anchors. For example, a cinching mechanism like
that described above may be provided in channel 2121 of outer
anchor 2124.
[0121] The delivery system 2100 may be used to secure torn tissue
to a bone. For example, in FIG. 26O, a torn labrum L is reattached
to the glenoid or acetabular rim in a shoulder or hip joint. Inner
and outer suture anchors 2122, 2124 are driven into the bone B and
suture coupled with the anchors captures the torn labrum L. This
helps to ensure that the mating bone BA (e.g. femoral or humeral
head) will not disengage from the socket during movement of the
joint.
[0122] FIGS. 27A-27D illustrate another embodiment of an anchor
delivery system. The anchor of this embodiment is similar to the
previous embodiment, except that the inner anchor and the outer
anchor are held side by side in the same or separate channels in
the delivery instrument, whereas in the previous embodiment the two
anchors are held end to end. In FIG. 27A, an outer shaft 2202
houses an outer suture anchor 2204 in a main channel 2214, an inner
suture anchor 2210 and a length of suture 2208 in a side channel
2216. The suture 2208 is coupled with both inner and outer anchors.
The outer anchor 2204 is held near the distal end of the main
channel 2214 and a first driving mandrel 2206 can be used to drive
the outer anchor 2204 into the bone B. The driving mandrel may be
actuated using any of the techniques disclosed herein, including
direct mechanical impaction, or by pneumatic, hydraulic, ultrasonic
or other means. Once the outer anchor has been driven into the
bone, the first driving mandrel 2206 is retracted as illustrated in
FIG. 27B. A flexible second driving mandrel 2212 is then advanced
either actively or by a spring in order to move the inner suture
anchor 2210 distally into the main channel 2214. A curved portion
near the distal end of the side channel moves the inner suture
anchor 2210 into the main channel 2214. Target tissue such as a
torn labrum L may be captured by looping the suture 2208 around the
tissue as seen in FIG. 27C. FIG. 27D shows that the inner suture
anchor 2210 is then driven by the second driving mandrel 2212 into
the first suture anchor 2204 where the two anchors lock together
using a locking mechanism similar to that previously described, or
using detent mechanisms or other locking mechanisms known in the
art. The free end F of the suture is then pulled in order to
tension the suture so that that the torn tissue properly engages
the bone. This allows the torn tissue to heal and reattach to the
bone. Any of the clamping, locking or cinching mechanisms described
above may be used to tension the suture in this embodiment.
[0123] FIGS. 28A-28C illustrate another embodiment of a suture
anchor delivery system. This embodiment uses jaws to help capture
the damaged tissue and also to help insert an inner suture anchor
into an outer suture anchor. In FIG. 28A, the delivery instrument
2302 includes an arm 2304 that is pivotably connected with the main
shaft 2303 of the delivery instrument, thereby forming a jaw. The
arm 2304 holds the inner suture anchor 2308 and the main shaft
holds the outer anchor 2306 such that the inner anchor 2306 is
aligned with aperture 2309 in the sidewall of outer anchor 2306
thereby being moved transverse to the longitudinal axis of outer
anchor 2306. A suture S is coupled to both anchors. In FIG. 28A,
the delivery instrument is advanced to the treatment site and the
jaw captures the damaged tissue, here a torn labrum L. The suture
is disposed between the torn tissue and the jaw. Once the damaged
tissue is captured, the outer anchor 2306 may be driven into the
bone, here the rim of the acetabulum A in a hip joint. Then the
inner anchor 2308 is driven through a lateral wall of the bone A
into the receiving aperture 2309 in the outer anchor where the two
anchors lock together as shown in FIG. 28B. The tension in the
suture is then adjusted using any of the cinching mechanisms
described above. In alternative embodiments, the inner anchor 2308
is snapped and locked into a receiving aperture of the outer anchor
2306 first, then the combined anchor is driven into the acetabular
rim A as shown in FIG. 28C. The suture is then tensioned as before.
In both embodiments, both the inner and outer suture anchors are
driven into the bone or into one another so that they are flush
with the outer surface of the bone.
[0124] FIGS. 29A-29B illustrate an embodiment similar to the
previous embodiment with the major difference being that the inner
anchor is inserted substantially parallel into the outer anchor,
unlike the previous embodiment where insertion of the inner anchor
is transverse to the outer anchor. In FIG. 29A, a delivery
instrument 2402 has a main shaft and an arm 2404 pivotably coupled
to the main shaft, forming a jaw. The arm 2404 carries the inner
anchor 2408 and the main shaft carries the outer anchor 2410. The
instrument is advanced to the treatment site and the tissue to be
repaired, here labral tissue L, is captured within the jaw. Suture
is coupled to both anchors and is disposed between the labrum L and
the jaw. The inner anchor 2408 is coupled to the outer anchor 2410
by moving jaw 2404. Then the combined inner and outer anchors are
driven into the bone using a separate driver 2406 inserted through
a separate portion in a direction substantially parallel to the
longitudinal axis of the anchors. In FIG. 29B, the suture is
tensioned using any of the cinching mechanisms described above,
thereby apposing the labrum with the acetabular rim A. FIG. 29C
shows that in some embodiments, either the jaw or the main shaft
may be forked in order to hold the inner 2408 or the outer 2410
anchor while allowing the anchor to be easily slipped off after
placement. Alternatively, either arm of the jaw may have a gripping
feature that frictionally engages either the inner diameter or the
outer diameter of the anchor. For example, in FIG. 29D a central
post 2412 holds the anchor, while in FIG. 29E, a tube 2414 grasps
the outer surface of an anchor.
[0125] The embodiments disclosed above may easily be modified in
order to accommodate more than one suture and/or more than one
anchor. For example, in FIG. 30, an outer suture anchor 2502 has
two channels 2504 that are sized to receive two inner anchors 2506.
Thus, in this embodiment, two sutures S, each having a free end F,
may be anchored to a single outer anchor. The same anchor may also
be used for three, four, five, six, or more sutures. The inner
anchors may be configured much like those described above with
suture cinching or locking mechanisms.
[0126] The suture anchors may be driven directly into bone or in
some situations, it may be desirable to drill a pilot hole to help
receive the anchor. For example, in FIG. 31, the central channel
2604 in the outer anchor 2602 that receives the inner anchor may
extend all the way through the outer anchor. Thus, the central
channel may also allow a pilot hole drill 2606 to pass through the
outer anchor and drill a pilot hole P in the bone. The pilot hole
allows the outer anchor to more easily be driven into the bone. As
described above, the pilot hole drill may be a mechanical drill,
laser, or water jet, and may be adapted for placement through the
instrument that delivers the anchor.
[0127] FIGS. 32A-32C illustrate another embodiment of a suture
anchor system that may be used to help reattach a torn labrum to
the acetabular or glenoid rim. In FIG. 32A, the anchor system
includes a first pin 2702 or screw, adapted for penetrating tissue
and anchoring in bone, and an L-shaped flexible anchor bracket 2704
having a curvature that conforms to the anatomy of the acetabular
rim and also to a torn labrum. A suture S is coupled to both the
pin 2702 and the bracket 2704. The bracket has a slit 2706 sized to
receive the suture preferably with an enlarged opening 2705 at its
inner closed end. FIG. 32B illustrates the back end of the bracket
2704 which has an anchoring pin 2708 or screw for attachment to
bone or other tissue. FIG. 32C illustrates use of the system where
the bracket 2704 is fixed to the acetabular or glenoid rim A and
extends around an edge of the torn tissue, here the labrum L. After
attachment of bracket 2704 to rim A, the suture S is wrapped under
the torn tissue capturing it in a loop and the suture is then
inserted into the slit 2706 closing the suture loop. The pin 2702
is then attached to the bone, here the actetabular rim A of a hip
joint having a surface of cartilage. Pin 2702 or bracket 2704 may
include any of the cinching mechanisms described above such that
the suture may be tensioned and locked. The bracket helps support
the torn tissue and also helps to prevent it from everting. Any
part of the system may include therapeutic agents to help the
labrum reattach to the bone and also the surface of the bracket may
be coated or modified to encourage tissue ingrowth. Bracket 2704 is
preferably a porous flexible material such as Dacron mesh, PTFE or
other polymer to encourage ingrowth of tissue but having sufficient
rigidity and resilience to support the labrum and allow some
movement thereof. In some embodiments, the bracket may be
reinforced with wires, fibers or other materials to give it
additional strength or shape. In addition, bracket 2704 or
anchoring pin 2708 may be adapted to couple with first pin 2702 in
a coupling mechanism similar to those described above.
[0128] FIG. 33 illustrates an alternative embodiment of a suture
anchor system used to reattach torn tissue to a bone. In FIG. 33, a
generally flat bracket 3302 is used to join the torn labrum L to
the acetabular rim A having a cartilage surface C. Pins or screws
3304 are used to secure one end of the bracket 3302 to the bone and
the other end of the bracket to the labrum L. A suture 3306 may be
coupled to the pins 3304 and used to adjust tension thereby
approximating the torn labrum L with the rim A. The pins may be
sharp pins or any of the anchor embodiments disclosed above.
Alternatively, in place of pin 3304, a suture may be attached to
bracket 3302 with a pin or other coupling member on its free end
adapted for coupling back to bracket 3302 or to pin 3304, or for
driving into bone. In alternative embodiments, the bracket may be
designed to clip onto the labrum and/or the acetabular rim and
therefore one or both pins may be optional. The bracket generally
has similar properties as described above with respect to bracket
2704, and any of the cinching mechanisms disclosed herein may be
incorporated into one or both pins in order to tension the
suture.
[0129] While the above is 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.
* * * * *