U.S. patent application number 14/615044 was filed with the patent office on 2015-06-11 for swivel anchor for knotless fixation of tissue.
The applicant listed for this patent is Arthrex, Inc.. Invention is credited to Stephen S. Burkhart, Peter J. Dreyfuss, R. Donald Grafton.
Application Number | 20150157312 14/615044 |
Document ID | / |
Family ID | 38473017 |
Filed Date | 2015-06-11 |
United States Patent
Application |
20150157312 |
Kind Code |
A1 |
Burkhart; Stephen S. ; et
al. |
June 11, 2015 |
SWIVEL ANCHOR FOR KNOTLESS FIXATION OF TISSUE
Abstract
A suture anchor for knotless fixation of tissue. A swivel suture
anchor has a rotatable anchor tip for receiving a suture strand,
for example a rotatable forked tip for capturing a suture chain,
for surgical tissue repair without requiring suture knots. Tension
on the repair constructs is adjustable through the selection of the
specific chain link or links of the suture chain captured by the
forked anchor tip of the suture anchor. The swivel anchor is
secured in a hole in bone by advancing a fixation device, such as a
cannulated interference screw, over the body of the anchor.
Inventors: |
Burkhart; Stephen S.; (San
Antonio, TX) ; Grafton; R. Donald; (Naples, FL)
; Dreyfuss; Peter J.; (Naples, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Arthrex, Inc. |
Naples |
FL |
US |
|
|
Family ID: |
38473017 |
Appl. No.: |
14/615044 |
Filed: |
February 5, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11802057 |
May 18, 2007 |
9005246 |
|
|
14615044 |
|
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|
60801097 |
May 18, 2006 |
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Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0409 20130101;
A61B 2017/044 20130101; A61B 2017/0412 20130101; A61B 2017/045
20130101; A61B 2017/0454 20130101; A61B 17/0401 20130101; A61B
2017/0408 20130101; A61B 2017/0438 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A suture anchor comprising: an anchor body; and an anchor tip
for receiving a strand of suture, the anchor tip being rotatably
attached to the anchor body.
2. The suture anchor of claim 1, wherein the suture anchor is
configured to allowed rotational insertion without causing
excessive twisting and knotting of a suture captured in the anchor
tip.
3. The suture anchor of claim 1, wherein the anchor tip comprises a
forked end configured to capture a suture.
4. The suture anchor of claim 1, wherein the anchor body is
threaded.
5. The suture anchor of claim 1, wherein the anchor tip is
detachable.
6. The suture anchor of claim 1, further comprising a fixation
device for securing the suture anchor in a hole in bone.
7. The suture anchor of claim 6, wherein the fixation device is a
cannulated interference screw.
Description
[0001] This application is a divisional of application Ser. No.
11/802,057, filed May 18, 2007, which claims the benefit of U.S.
Provisional Application Ser. No. 60/801,097, filed May 18, 2006,
the entire disclosure of which is incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to surgical fixation and, more
particularly, to methods of conducting anatomical tissue repair,
such as ligament repair and reconstruction, using a swivel suture
anchor for knotless tissue fixation.
[0004] 2. Description of the Related Art
[0005] Securing suture during surgery can be difficult and
demanding. Various suture constructs have been developed in an
effort to avoid the need to tie knots in suture, particularly
during arthroscopic surgery. For example, U.S. Pat. No. 6,143,017
to Thal discloses tissue fixation using a free-standing continuous
suture loop that is snagged by an anchoring device. While it
appears that tissue can be bound to bone according to the Thal
teachings, it is not evident how to accomplish in situ surgical
refinements such as adjustment of the loop length or tension on the
repaired tissue. Accordingly, there exists a need in the art for
improved technology for knotless tissue fixation.
SUMMARY OF THE INVENTION
[0006] The present invention provides apparatus and methods for
anatomical tissue repair and reconstruction, using a swivel anchor
for knotless tissue fixation. In one method of tissue fixation, the
swivel anchor is used with a suture chain formed of at least two
loops formed of high strength suture. A driver is provided direct
the tip of the swivel anchor to capture loops of the suture chain.
The swivel anchor is locked and secured in bone by inserting a
cannulated fixation device (for example, an anchor, an interference
plug or screw, or an implant) over the anchor.
[0007] The present invention also provides a method for knotless
fixation of anatomical tissue during surgical applications by
employing a swivel anchor assembly and a suture chain. The method
comprises the steps of: (i) providing a suture chain formed of at
least two loops formed of and connected by suture; (ii) securing an
end of the suture chain to a fixation device; (iii) securely
engaging a swivel anchor with at least a portion of the fixation
device; and (iv) pulling on the other end of the suture chain to
tension the suture chain and the tissue coupled thereto.
[0008] Other features and advantages of the present invention will
become apparent from the following description of exemplary
embodiments of the invention described with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1-8a depict a series of subsequent steps of shoulder
repair using a single-row technique with a swivel anchor device
according to the present invention.
[0010] FIGS. 9-16a depict a series of subsequent steps of shoulder
repair using a double-row technique with a swivel anchor device
according to the present invention.
[0011] FIGS. 17a-17b illustrate various views of a driver assembly
comprising a rod, an inserter member, a threaded gauge and an end
piece, according to the present invention.
[0012] FIG. 18 illustrates various views of the inserter member of
the driver assembly of FIG. 17.
[0013] FIG. 19. illustrates various views of the threaded gauge
with thumb pad of the driver assembly of FIG. 17.
[0014] FIG. 20 illustrates various views of the rod of the driver
assembly of FIG. 17.
[0015] FIG. 21 illustrates various views of a swivel anchor
according to the present invention.
[0016] FIG. 22 illustrates various views of a fixation device
according to the present invention and used in conjunction with the
swivel anchor of FIG. 20 and the driver of FIG. 17.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] The present invention provides apparatus and methods for
knotless tissue fixation using a swivel anchor device. In a
preferred method, the swivel anchor is used with a suture chain
formed of at least two loops of suture, preferably high strength
suture. The loops of the chain are captured by mounting the swivel
anchor on a driver. The driver is also used to engage and lock the
swivel anchor in a hole in bone by inserting a cannulated fixation
device (for example, an anchor, an interference plug or screw, or
an implant) over the anchor.
[0018] The present invention also provides a method for knotless
fixation of anatomical tissue during surgical applications by
employing a swivel anchor and a suture chain. The method comprises
the steps of: (i) providing a suture chain formed of at least two
loops formed of and connected by suture; (ii) securing an end of
the suture chain to a fixation device; (iii) securely engaging a
swivel lock with at least a portion of the fixation device; and
(iv) pulling on the other end of the suture chain to tension the
suture chain and the soft tissue coupled thereto.
[0019] Suture chains used in accordance with the present invention
are described in detail in U.S. Application Publication No.
2006/0259076, the entire disclosure of which is incorporated by
reference herein. The term "chain" is used in the specification and
claims to refer to exemplary embodiments of the invention. A
"chain" in this context refers broadly to a suture construct formed
of a series of suture loops. The loops can be, but need not be,
interlinked. In this manner, the term "chain" as used in this
application includes, but need not be limited to, the commonly
understood definition in which links or rings are fitted into one
another. Rather, the chains of the present invention can include
two or more loops that are connected together. Each loop preferably
has a fixed perimeter. The suture can be interlaced, rather than
knotted, as described further below, to establish and maintain loop
geometry. Preferably, all loops are similar in size.
[0020] Referring now to the drawings, where like elements are
designated by like reference numerals, FIGS. 1-16 illustrate two
surgical procedures of approximating tissue (for example, a torn
tendon) to bone according to exemplary embodiments of the present
invention. For simplicity, the invention will be described below
with reference to fixation of the rotator cut however, the
invention is not limited to this exemplary embodiment and has
applicability to fixation of tissue in general, such as, for
example, fixation of torn tendons in ACL reconstructions of the
knee or in fixation of any tendon to bone.
[0021] Method steps of tissue fixation according to exemplary
embodiments of the present invention are depicted schematically in
FIGS. 1-16. As described in more detail below, FIGS. 1-8 illustrate
sequential steps during a rotator cuff repair using a knotless
single row technique and FIGS. 9-16 illustrate sequential steps
during a rotator cuff repair using a knotless double row technique.
Both techniques will be described with reference to driver assembly
100 (FIGS. 17-20), swivel lock anchor 200 (FIG. 21) and fixation
device 300 (FIG. 22).
[0022] Although the single and double row techniques are described
below with reference to specific instruments sold by Arthrex, Inc.,
the assignee of the present application, and with reference to a
series of specific steps and devices used during the surgical
tissue fixation, it should be understood that the invention is not
limited to the specific disclosure of these embodiments and
contemplates modifications and variations that are apparent to
those skilled in the art. Accordingly, the invention must not be
limited to the specific embodiments detailed below, as they are
only exemplary in nature.
Knotless Single Row Repair Technique--FIGS. 1-8
[0023] FIGS. 1-8 illustrate a series of subsequent steps in
shoulder repair for a single-row repair technique using a swivel
lock device according to the present invention.
[0024] The mobility of the tear is assessed using a suture
retriever/tissue grasper 105, such as the Arthrex KingFisher.TM.
Suture Retriever/Tissue Grasper, as shown in FIG. 1. In the case of
a large U-shaped tear, margin convergence suturing may be required
before approximation. Then, a shaver, high-speed burr, or chondro
pick is used to prepare a bleeding bone bed.
[0025] As shown in FIG. 2, the non-linked, free end 10a of a suture
chain 10, such as the Arthrex FiberChain, is passed through the
rotator cuff 150 using a suture passer 110, such as the Arthrex
Scorpion.TM. Suture Passer, through a cannula, such as an Arthrex
5.75 mm Crystal Cannula. Next, the suture is retrieved through the
same cannula.
[0026] Then the free end 10a of suture chain 10 is passed through
the terminal link 10b at its opposite end, as shown in FIG. 3. The
loop 10b is cinched down by pulling on the free end 10a of the
suture chain 10. The tip of the cannula may be used to help seat
the suture chain loop securely against the rotator cuff 150. A
suture retriever/tissue grasper 105 may be useful to ensure that
the loop has been fully tightened. The, the second suture chain 11
is passed through the rotator cuff 150, the free end passed through
the terminal loop, and the loop cinched in the same manner as for
the first suture chain 10.
[0027] As shown in FIG. 4, the suture chain 10, 11 is used as a
traction suture to determine the desired anchor location adjacent
to the rotator cuff margin and a bone socket 155 is punched through
a superolateral percutaneous portal with a punch 115, such as the
Arthrex 5.5 mm Bio-Corkscrew FT Punch. A second bone socket 155 is
also formed in the same manner for the second fiber chain 11.
[0028] As shown in FIG. 5, both suture chain ends 10a, 11a are
retrieved through the lateral portal. The swivel anchor 200 of the
present invention is introduced through the percutaneous
superolateral portal and captures the third link 10c from the free
margin of the rotator cuff 150. The link 10c is captured by the
forked anchor tip 250 of the anchor 200 (see FIG. 21). In a
preferred embodiment, each link in the suture chain 10 is
approximately 6 mm in length; therefore, since the total length of
the swivel anchor 200 is 18 mm, capturing the third link 10c from
the cuff edge will usually position the cuff directly at the edge
of the bone socket 155 and perfectly tension the suture chain 10
and the rotator cuff 150 segment that it spans, when the anchor tip
250 pushes the suture chain 10 to the bottom of the bone socket
155.
[0029] The tissue tension is then evaluated, as shown in FIGS.
6a-6b. The driver assembly 100 is advanced into the bone socket 155
and the suture chain 10 is pushed toward the bottom of the socket
155 until the anchor body 225 contacts the bone. If the tension is
not adequate, the driver 100 is removed from the bone socket 155 by
pulling on the free end of the suture chain 10 (to release any
wedging of the swivel-tip 250) at the same time that the driver
assembly 100 is withdrawn. Then the adjacent, more proximal link is
instead captured. If the tension is too great to fully insert the
driver 100 to the bottom of the bone socket 155, the driver 100 is
removed and the adjacent, more distal link is captured. Then the
driver 100 is reinserted to the base of the bone socket. The forked
tip 250 of the implant 200 is held to the driver with a zero
retention suture cleated at the driver's proximal end.
[0030] Fixation device 300, such as a screw, is advanced by driver
assembly 100 by holding the thumb pad 50 as the inserter handle 22
is turned clockwise, as shown in FIGS. 7 and 7a. When the implant
400 is fully seated, the shaft 225 of the anchor 200 is fully
engaged by the fixation device 300 to optimize the stability of the
swivel anchor construct 400. The swivel anchor construct 400
comprises anchor 200 and fixation device 300. The tip retention
suture is unwound from the cleat at the back of the driver handle
22 and the driver assembly 100 is removed. Then, one limb of the
retention suture is pulled to fully remove it from the implant.
[0031] The insertion steps are repeated for the second swivel
anchor construct 400 to obtain the final suture/anchor construct,
shown in FIGS. 8 and 8a. The free suture ends 10a, 11a are cut with
a suture cutter, such as the Arthrex open ended FiberWire Suture
Cutter, so that they are flush with the edge of the bone socket
155.
Knotless Double Row Repair Technique--FIGS. 9-16
[0032] FIGS. 9-16 illustrate a series of subsequent steps in
shoulder repair for a double-row repair technique using a swivel
anchor according to the present invention.
[0033] The mobility of the tear is assessed using suture
retriever/tissue grasper. In the case of a large U-shaped tear,
margin convergence suturing may be required before approximation of
the tendon. A shaver, high-speed burr, or chondro pick is used to
prepare a bleeding bone bed. Then, as shown in FIG. 9, pilot holes
160 are prepared for two suture anchors 120, such as Arthrex
Bio-Corkscrew FT suture anchors, that will comprise the medial row
through a percutaneous superolateral portal. A punch 115, such as
the Arthrex 5.5 mm Bio-Corkscrew FT Punch, is advanced to the laser
line at a 45.degree. "deadman" angle, adjacent to the articular
margin of the humerus to form the pilot holes 160. Tapping is
seldom, but may be, necessary.
[0034] As shown in FIGS. 10 and 10a, both suture anchors 120 are
placed. In a preferred embodiment, the suture anchors 120 come
preloaded with suture chain 10.
[0035] Then, as shown in FIG. 11, the suture leader is retrieved
from one of the suture chain 10 strands through the lateral portal
and is loaded onto a suture passer 110, such as the Arthrex
Scorpion Suture Passer. The suture chain 10 suture leader is passed
through the rotator cuff 150 approximately 15 mm from the free
margin of the rotator cuff 150. This step is then repeated for the
second suture chain 11.
[0036] As shown in FIG. 12, both suture chain suture ends 10a, 11a
are retrieved through the lateral portal and are tensioned to bring
the cuff into contact with the medial portion of the footprint. The
tip of the cannula may be used to push the tendon against the
footprint. Then two bone sockets 155 are formed for the lateral row
swivel anchors 200 using a punch 115. These two bone sockets 155
should be adjacent to the lateral margin of the cuff 150 when the
cuff 150 is appropriately tensioned by the two previously placed
suture chains 10, 11.
[0037] As shown in FIG. 13, the swivel anchor 200 is introduced
through the percutaneous superolateral portal, capturing the third
link 10c from the free margin of the rotator cuff 150. The link 10c
is captured by the forked anchor tip 250 of the anchor 200 (see
FIG. 21). In a preferred embodiment, each link in the suture chain
10, 11 is approximately 6 mm in length; therefore, since the total
length of the swivel anchor 200 is 18 mm, capturing the third link
from the cuff edge will usually position the cuff directly at the
edge of the bone socket 155 and perfectly tension the suture chain
10 and the rotator cuff segment that it spans when the anchor tip
250 pushes the suture chain 10 to the bottom of the bone socket
155.
[0038] The tissue tension is then evaluated, as shown in FIG. 14.
The driver assembly 100 is advanced into the bone socket 155 and
the suture chain 10 is pushed toward the bottom of the socket 155
until the anchor body 225 contacts the bone. If the tension is not
adequate, the driver is removed from the bone socket by pulling on
the free end of the suture chain 10 (to release any wedging of the
swivel-tip 250) at the same time that the driver assembly 100 is
withdrawn and the adjacent, more proximal link is instead captured.
If the tension is too great to fully insert the driver to the
bottom of the bone socket 155, the driver assembly 100 is removed
and the adjacent, more distal link is instead captured. Then the
driver 100 is reinserted to the base of the bone socket 155.
[0039] Fixation device 300, e.g., a screw, is advanced by holding
the thumb pad 50 as the inserter handle 22 is turned clockwise, as
shown in FIGS. 15 and 15a. When the implant 400 is fully seated,
the shaft 225 of the anchor 200 is fully engaged by the body of the
fixation device 300 to optimize the stability of the swivel anchor
construct 400. As previously stated, the swivel anchor construct
400 comprises anchor 200 and fixation device 300. The tip retention
suture is unwound from the cleat at the back of the driver handle
200 and the driver 100 is removed. One limb of the retention suture
is pulled to fully remove it from the implant.
[0040] The steps of FIGS. 13-15 are then repeated for the second
swivel anchor construct 400 to obtain the final construct, shown in
FIGS. 16 and 16a. The free suture ends are cut with a suture cutter
so that they are flush with the edge of the bone socket 155.
[0041] In addition to the above exemplary embodiments, the
invention may also be used for a side-to-side closure of soft
tissue using a suture chain 10. This method includes using the
suture chain 10 to perform the side-to-side closure of the soft
tissue with a final step of anchoring a chain link at the lateral
aspect of the repair to bone using an anchor, such as anchor 200.
The anchoring step is the same as that illustrated in the first two
embodiments. Furthermore, if the soft tissue split to be repaired
overlies bone for its entire length, a suture anchor, similar to
suture anchor 120, may be inserted into bone at the medial aspect
of the repair, a side-by-side margin convergence is implemented
using the suture chain in a "shoelace-type" stitch, and the suture
chain is anchored at the lateral aspect of the repair to bone using
an anchor, such as anchor 200.
[0042] Reference is now made to FIGS. 17a-22, which illustrate
details of the driver assembly 100 (FIGS. 17-20), the swivel suture
anchor 200 (FIG. 21) and the fixation device 300 (FIG. 22). As
illustrated in FIGS. 17a-20, driver assembly 100 comprises a
cannulated driver 20 including shaft 25 and inserter handle 22;
tube or rod 30 that passes slidably and rotatably through the
cannulated driver 20; threaded gauge 40 including a cannulated body
42 and thumb pad 50; and tip 44. FIG. 17a illustrates the driver
assembly 100 in assembled (A) form and FIG. 17b illustrates the
driver assembly 100 in unassembled (B) form. FIG. 18 provides a
more detailed view of the cannulated driver 20 of the driver
assembly 100. FIG. 19 provides a more detailed view of the threaded
gauge 40 of the driver assembly 100. FIG. 20 provides a more
detailed view of the rod 30 of the driver assembly 100.
[0043] FIG. 21 illustrates various views of swivel anchor 200.
During installation of swivel anchor 200, the anchor body 225 is
assembled onto the operational end of the driver 100. The anchor
tip 250 is threaded or otherwise attached onto the tip of thin rod
or tube 30. As detailed above, forked anchor tip 250 is used to
capture a suture chain 10, 11 (that has been laced through a
shoulder ligament, as shown in the two exemplary embodiments above)
for installation into a pre-drilled hole 155 in bone. The suture
anchor 200 has a threaded body 225 and a detachable forked tip 250.
The forked tip 250 may be rotatably attached to the anchor body
225. This enables rotational insertion of the suture anchor 200
without causing excessive twisting and knotting of the suture chain
10, 11 by the forked tip 250.
[0044] FIG. 22 illustrates various views of a fixation device 300
(for example, a cannulated interference screw) that is employed in
conjunction with the driver assembly 100 and the swivel anchor 200.
Preferably, the fixation device 300 is preloaded on the driver
assembly 100. As described above with reference to the two
exemplary embodiments, the fixation device 300 is advanced into the
bone socket 155 by holding the thumb pad 50 as the inserter handle
22 is turned clockwise. When the fixation device 300 is fully
seated, the shaft 225 of the forked swivel anchor 200 is fully
engaged by the fixation device 300 to optimize the stability of the
swivel anchor construct 400. As previously stated, the swivel
anchor construct 400 is composed of anchor 200 and fixation device
300.
[0045] In the two exemplary embodiments detailed above, suture
anchor 200 is an Arthrex Swivel-Lock.TM. (swivel suture anchor).
However, suture anchor 200 may be also a bone anchor or an Arthrex
Push-Lock.TM.-type anchor including a forked tip in order to
capture a given link of the suture chain. Alternatively, the suture
chain 10, 11 passed through the tissue can be secured either using
a single anchor or a plurality of anchors. In addition, various
anchors, such as those noted above and others, may be used
interchangeably with only slight variations in the above procedure.
For example, the suture chain 10, 11 can be secured by capturing
two of the chain loops in forked tines prior to insertion of the
anchor or anchors.
[0046] Further, regular suture may be used in addition to the
suture chains of the present invention. In this case, the first
suture anchor 120 of the double row embodiment will be pre-loaded
with regular suture (for example, the Arthrex BioCorkscrew.TM. or
Arthrex BioCorkscrew-FT.TM., disclosed in U.S. Application
Publication No. 2007/0060922). In an exemplary embodiment using
regular suture, the technique is similar to the one described
above, except that the lateral fixation is accomplished by
capturing the suture limbs (rather than chain-links) in the fork of
the anchor 200 and tensioning the suture as the anchor 200 is
placed. This relies on interference fixation of the suture between
the anchor 200 and the bone.
[0047] As described above, the swivel anchor and suture chain
assembly of the present invention has application in surgical
tissue repair, for example, in conjunction with one or more bone
anchors. Tension on repair constructs is adjustable through
selection of the chain link or links to be snagged by a bone
anchor.
[0048] Although the present invention has been described in
relation to particular embodiments thereof, many other variations
and modifications and other uses will become apparent to those
skilled in the art. It is preferred, therefore, that the present
invention be limited not by the specific disclosure herein.
* * * * *