U.S. patent application number 17/745986 was filed with the patent office on 2022-09-01 for partial thickness rotator cuff repair system and method.
The applicant listed for this patent is DePuy Synthes Products, Inc.. Invention is credited to Kristian DiMatteo, Mehmet Ziya Sengun, Gregory R. Whittaker.
Application Number | 20220273285 17/745986 |
Document ID | / |
Family ID | 1000006335382 |
Filed Date | 2022-09-01 |
United States Patent
Application |
20220273285 |
Kind Code |
A1 |
DiMatteo; Kristian ; et
al. |
September 1, 2022 |
PARTIAL THICKNESS ROTATOR CUFF REPAIR SYSTEM AND METHOD
Abstract
A suture anchor is disclosed which has an elongated body having
a distal end, a proximal end and an exterior surface. An axially
oriented bore extends into the body from the proximal end and a
proximal portion of the bore has a plurality of abutment surfaces
for engaging a tool. The bore includes one or more axially oriented
suture passages leading to a suture attachment within the bore. A
length of suture extends into the at least one suture passage from
the body proximal end and extends to the suture attachment. A screw
thread spirals about a portion of the exterior surface of the body
adjacent the at least one suture passage. Between the bore and the
exterior surface of the body the body has a wall thickness and
wherein the suture passage comprises the area where the wall
thickness goes to zero.
Inventors: |
DiMatteo; Kristian;
(Waltham, MA) ; Whittaker; Gregory R.; (Stoneham,
MA) ; Sengun; Mehmet Ziya; (Canton, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DePuy Synthes Products, Inc. |
Raynham |
MA |
US |
|
|
Family ID: |
1000006335382 |
Appl. No.: |
17/745986 |
Filed: |
May 17, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16382792 |
Apr 12, 2019 |
|
|
|
17745986 |
|
|
|
|
14166941 |
Jan 29, 2014 |
|
|
|
16382792 |
|
|
|
|
12609122 |
Oct 30, 2009 |
8672967 |
|
|
14166941 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/044 20130101;
A61B 2017/0414 20130101; A61B 2017/0445 20130101; A61B 17/0401
20130101; A61F 2/0811 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1-14. (canceled)
15. A method of performing a partial thickness rotator cuff repair,
the method comprising the steps of: inserting a first suture anchor
through a tendon of the rotator cuff and then anchoring the first
suture anchor into the humerus, the first suture anchor including
(i) an elongated body having an axially oriented bore into the
body, the bore including at least one axially oriented suture
passage and a wall thickness between the bore and an external
surface of the body, (ii) a suture of gauge #2 or lower passing
into the bore, around a suture attachment in the bore and back out
of the bore, (iii) a maximum outer diameter of 4 mm, and (iv)
external threads about a portion of the exterior surface of the
body adjacent the at least one suture passage; wherein the first
suture anchor being threaded into the humerus during the step of
anchoring and wherein the suture passage comprising an area where
the wall thickness goes to zero between the external threads and
the bore; and wherein the first suture anchor has a pull-out
resistance from the humerus of at least 25 pounds; inserting a
second suture anchor into the humerus; passing a first length of
suture from the first suture anchor through the tendon and to the
second suture anchor whereby to hold the tendon to the humerus.
16. A method according to claim 15 wherein the first suture anchor
is formed of a bioabsorbable material.
17. A method according to claim 15 wherein the first suture anchor
is not proud of a surface of the humerus.
18. A method according to claim 15 and further comprising the step
of passing a second length of suture from the first suture anchor
and through the tendon.
19. A method according to claim 18 and further comprising the step
of anchoring a third suture anchor into the humerus and passing the
second suture to the third suture anchor.
20. A method according to claim 15 wherein the first suture anchor
has a maximum diameter of 3.5 mm.
21. A method according to claim 20 wherein the first anchor has a
maximum diameter of 2.8 mm.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 16/382,792, which is a continuation of
U.S. patent application Ser. No. 14/166,941 which is a divisional
application of U.S. patent application Ser. No. 12/609,122,
entitled PARTIAL THICKNESS ROTATOR CUFF REPAIR SYSTEM AND METHOD,
filed Oct. 30, 2009, now U.S. Pat. No. 8,672,967 all of which are
incorporated herein by reference in their entireties.
BACKGROUND
[0002] The present application relates to systems and methods for
performing a repair of a partial thickness rotator cuff tear.
[0003] A PASTA (Partial Articular Surface Tendon Avulsion) lesion
in a rotator cuff of a shoulder can be particularly difficult to
repair. The rotator cuff comprises a group of muscles which
surround the shoulder and tendons which attach those muscles to the
humeral head. The tendons have a footprint where they attach to the
humeral head and in a PASTA lesion a portion of the tendon's
footprint becomes detached from the humeral head. Such lesions are
most commonly found on the supraspinatus tendon. One option for
treatment is completion of the tear and repair using standard
techniques for a full thickness tear. Preservation of the existing
attachment is thus lost and the entire tendon must be reattached. A
further option is to create an incision through the tendon and
place a standard suture anchor therethrough. This creates
significant trauma to the tendon.
SUMMARY OF THE INVENTION
[0004] The present invention provides systems and methods for
repairing a PASTA lesion which provides advantages over current
treatment options. A suture anchor according to the present
invention comprises an elongated body having a distal end, a
proximal end and an exterior surface. An axially oriented bore
extends into the body from the proximal end and a proximal portion
of the bore has a plurality of abutment surfaces for engaging a
tool. The bore has at least one axially oriented suture passage. A
suture attachment is associated with the bore. A screw thread
extends about a portion of the exterior surface of the body
adjacent the at least one suture passage. The body has a wall
thickness between the bore and the exterior surface of the body,
the suture passage comprising an area where the wall thickness goes
to zero.
[0005] Preferably, the wall thickness is zero along substantially
an entire length of the bore.
[0006] Preferably, the abutment surfaces form a tool receiving
recess and wherein the at least one suture passage comprises a
first suture passage on a first side of the tool receiving recess
and a second suture passage on a second side of the tool receiving
recess. A length of suture can pass down the first suture passage
to the suture attachment and then back out the second suture
passage. Preferably, the tool receiving recess extends
substantially from the body proximal end to the suture attachment
providing good purchase for the tool and reducing stress upon the
anchor body during tool use. In one embodiment, the threads have a
maximum outer diameter less than 4 mm and wherein the suture is of
gauge #2 or lower. Preferably, the threads have a maximum outer
diameter less than 3.5 mm, and more preferably, a maximum outer
diameter of 2.8 mm.
[0007] Preferably, the suture anchor has a pullout resistance of at
least 25 lbs.
[0008] In one embodiment, the body is formed of a bioabsorbable
polymer and in an alternative embodiment of Titanium.
[0009] Preferably, the suture attachment comprises a cross member
disposed within the bore allowing sliding of the suture
therethrough.
[0010] Preferably, the suture anchor further comprises a driver
inserted into a tool receiving recess formed between the abutment
surfaces, the driver comprising complementary surfaces in
engagement with the abutment surfaces whereby to apply torque to
the suture anchor body. Preferably, the driver further comprises at
least one suture receiving groove adjacent the complementary
surfaces and in registry with the at least one suture passage in
the anchor body.
[0011] A method according to the present invention provides for
performing a partial thickness rotator cuff repair. The method
includes the steps of: inserting a first suture anchor having a
maximum diameter of 4.0 mm through a tendon of the rotator cuff and
anchoring it into the humerus; inserting a second suture anchor
into the humerus; passing a first length of suture from the first
suture anchor through the tendon and to the second suture anchor
whereby to hold the tendon to the humerus.
[0012] In one embodiment of the method, the first suture anchor is
formed of a bioabsorbable material. Preferably, after insertion,
the first suture anchor is not proud of a surface of the humerus.
Preferably, the method further comprises the step of passing a
second length of suture from the first suture anchor and through
the tendon. It can further comprise anchoring a third suture anchor
into the humerus and passing the second suture to the third suture
anchor.
[0013] Preferably, the first suture anchor has a maximum diameter
of 3.5 mm, and more preferably 2.8 mm.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of a suture anchor according to
the present invention;
[0015] FIG. 2 is a side elevation view of the suture anchor of FIG.
1 loaded onto a driver;
[0016] FIG. 3 is a top plan view of the suture anchor of FIG.
1;
[0017] FIG. 4. is a side elevation view of a humerus and associated
rotator cuff tendon suffering a PASTA lesion showing a K wire being
inserted through the tendon to a desired location for placing a
suture anchor;
[0018] FIG. 5. is a side elevation view of the tendon of FIG. 4
showing a cannula system being passed through the tendon over the K
wire;
[0019] FIG. 6 is a perspective view of the cannula system of FIG.
5;
[0020] FIG. 7 is a side elevation view of the tendon of FIG. 4 a
suture anchor loaded onto a driver being passed therethrough via an
outer portion of the cannula system;
[0021] FIG. 8 is a side elevation view of the tendon of FIG. 4
showing the suture anchor implanted into the humerus beneath the
tendon and a limb of suture passing from the suture anchor out of
an anterior cannula;
[0022] FIG. 9 is a side elevation of the tendon of FIG. 4 showing a
spinal needle passed through a location on the tendon and a suture
retriever being passed through the spinal needle and out of the
anterior cannula;
[0023] FIG. 10 is a side elevation of the tendon of FIG. 4 showing
both suture limbs passed from the suture anchor and through the
tendon at different locations; and
[0024] FIG. 11 is a side elevation of the tendon of FIG. 4 showing
the suture limbs knotted together to compress the tendon to the
humerus thus effecting repair of the PASTA lesion.
DETAILED DESCRIPTION
[0025] FIG. 1 depicts a suture anchor 10 according to the present
invention. It comprises an elongated body 12 having a pointed
distal tip 14 and a proximal end 16. An axial passageway 18 extends
into the body 12 from the proximal end 16. The passageway 18 is
open along its sides 20 defining a pair of spines 21 of the
remaining material of the body 12. A thread 22 encircles the body
12. A suture bridge 24 spans the passageway 18 laterally at a
distal portion 26 thereof.
[0026] Turning also now to FIGS. 2 and 3, an inserter 28 fits into
the passageway 18. A length of suture 30 passes around the suture
bridge 24 and is received within longitudinal grooves 32 on the
inserter 28. As best seen in FIG. 3, the cross-sectional shape of
the passageway 18 at the proximal end 16 is essentially a hexagon
34 with a pair of suture passages 36 on opposite corners thereof.
The suture passages 36 lead to either side of the suture bridge 24.
The inserter 28 has a complimentary shape to fit within the hexagon
34 with its grooves 32 in alignment with the suture passages 36 on
the anchor 10.
[0027] The suture anchor 10 as shown with the suture passages 36
penetrating the body 12 to leave the passageway 18 open except for
the thread 22 minimizes its cross section to provide the least
trauma to soft tissue through which it will pass while still having
sufficient mechanical strength for the driver 28 to drive it into
bone. Where additional fixation strength within the bone may be
required the cross section of the anchor 10 could be enlarged, in
which case the suture passages 36 need then not necessarily
penetrate the body 12 laterally. The anchor 10 can be formed of any
suitable biocompatible material such as stainless steel, titanium,
cobalt chrome, PEEK (polyaryletheretherketone), other biocompatible
polymers, polymer-ceramic composites, bioabsorbable polymers and
the like.
[0028] FIGS. 4 to 10 illustrate a procedure to repair a PASTA
lesion using the suture anchor 10 of FIG. 1. As seen in FIG. 4,
either percutaneously or arthroscopically, a Kirschner wire (K
wire) 38 is inserted at a first location 39 through a tendon 40 of
a rotator cuff to a desired anchor site 42 beneath its attachment
footprint 44 and positioned upon an associated humeral head 46. The
K wire 38 can be tapped in or merely positioned at the site 42. To
ease manipulation of the K wire 38 it is preferably textured on its
outer surface and may be provided with a removable proximal handle
(not shown). This site 42 on the humeral head 46 is where the
suture anchor 10 (see FIG. 1) will be implanted.
[0029] As seen in FIG. 5, a cannula system 48 is passed over the K
wire 38 and through the tendon 40 to the site 42. FIG. 6 shows the
cannula 48 in more detail. It comprises an inner cannula 50 having
a sharp distal tip 52, proximal handle 54 and a lumen 56
therethrough. The inner cannula 50 fits within an outer cannula 58
which has a distal end 60, proximal handle 62 and lumen 64
therethrough. The distal tip 52 of the inner cannula 50 extends
slightly beyond the distal end 60 of the outer cannula 58 and the
distal end 60 is tapered so that rather than core through the
tendon 40 the distal tip 52 creates a small hole and the tapering
on the distal tip 52 and distal end 60 allow the cannula system 48
to push aside the tissue and create the smallest hole through the
tendon 40 with the least damage thereto. Prior cannulas were
inserted through a slit cut into the tissue. The cannula system 48
dilates the tissue gently to minimize trauma to the tissue. The
outer cannula 58 has lines 66 which provide a visual indication of
depth penetration and also a visualization window 68 which aids in
anchor insertion and assessment of appropriate depth into the bone.
To prevent slippage of the inner cannula 50 relative to the outer
cannula 58 during insertion so provision is preferably provided to
help keep them together. Shown are an interlocking nub 70 and
groove 72, but other options such as a friction fit, threading,
magnets etc. could be employed.
[0030] As seen in FIG. 7, in preparation for insertion of the
anchor 10, the K wire 38 and inner cannula 50 are removed leaving
the outer cannula 58 positioned at the anchor site 42. The suture
anchor 10 is preloaded onto the inserter 28, with the suture 30 in
place around the suture bridge 24 and passing through the suture
passages 36 and grooves 32 (see FIG. 2), is passed down through the
outer cannula lumen 60 to the anchor site 42 and is then driven
into the humeral head 46. If the anchor 10 is formed of a
biocompatible metal such as stainless steel or titanium it can be
simply twisted in via the inserter 28. If instead it is formed of a
bioabsorbable polymer or other material having less strength a
pilot hole should be prepared such as with a drill, tap or awl, at
the site 42 through the cannula 46 prior to inserting the anchor 10
through the lumen 60. The inserter 28 and outer cannula 58 can then
be removed leaving first and second suture limbs, 74 and 76
respectively, passed up through the tendon 40 at the first location
39 through which the cannula 48 had passed. As seen in FIG. 8, the
first suture limb 74 is then retrieved through an auxiliary cannula
78 such as via a grasper (not shown).
[0031] As seen in FIG. 9 a spinal needle 80 is passed through the
tendon 40 at a second location 82 spaced apart from the first
location 39. A flexible wire suture capture device 84 having a
suture capture loop 86 (such as a Chia Percpasser available from
DePuy Mitek, Inc. of Raynham, Mass.) is passed through the spinal
needle 80 and retrieved out through the auxiliary cannula 78 so
that the first suture limb 74 can be threaded through the suture
capture loop 86. When the spinal needle 80 and suture capture
device 84 are pulled back through the skin this pulls the first
suture limb 74 through the tendon 40 at the second location 82. For
a quick procedure, the first and second suture limbs 74 and 76
could now be knotted together tying down the tendon 40. However, it
is preferable to repeat the procedure of FIGS. 8 and 9 with the
second suture limb 76 to pass it through the tendon 40 at a third
location 88 on an opposite side of the first location 39 as shown
in FIG. 10. To ease in knot tying both suture limbs 74 and 76 are
preferably pulled out through a single portal such as the auxiliary
cannula 78 or other portal through the skin. A knot 90 can then be
tied and pushed down to tightly secure the tendon 40 to the humeral
head 46 as shown in FIG. 11. By passing the suture limbs 74 and 76
through the tendon 40 at locations 82 and 88 on opposite sides of
the first location 39 and defect caused at that location via the
passing of the cannula system 48 will be naturally pulled together
when the knot 90 is tightened.
[0032] Depending upon the extent of the PASTA lesion it may be
desirable to place more than one suture anchor 10 beneath the
tendon 40. In such case the suture limbs therefrom can be tied
together. It would still be preferable to pass them through the
tendon at separate locations as illustrated in FIGS. 9 and 10 prior
to tying them together, preferably in a mattress pattern. Also, a
repair could be fashioned employing one or more knotless suture
anchors (not shown) such as disclosed in U.S. Published Application
No. 2008/0033486, incorporated herein by reference placed at a
location 92 laterally of the tendon 40 and wherein the suture limbs
74 and 76 from the one or more anchors 10 can be passed in a dual
row procedure, preferably also employing a mattress pattern. If a
lateral anchor is employed, one such method is to put the a pair of
present suture anchors 10 anterior and posterior and have one limb
74 from each tied to each other and the other limbs 76 spanned to
the lateral anchor (preferably knotless) such that it forms a
triangle.
[0033] The suture anchor 10 and cannula system 48 may also be used
to effect repair of a SLAP (Superior labral tear from Anterior to
Posterior) lesion. Typically a much larger traditional cannula (7-8
mm) is placed thru the rotator cuff to access the superior labrum
for a SLAP repair. The present cannula system is much smaller and
also due to its tendency to dilate the tissue rather than be
inserted through a large slit would inflict less trauma to the
rotator cuff. Such a procedure may be as follows: insert the K wire
38, and then the cannula system 48 in the fashion heretofore
described through the rotator interval; drill a hole in the glenoid
rim; insert the anchor 10; remove the cannula system 48; pass
suture through the labrum using a suture shuttle; and tie
knots.
[0034] While the invention has been particularly described in
connection with specific embodiments thereof, it is to be
understood that this is by way of illustration and not of
limitation, and that the scope of the appended claims should be
construed as broadly as the prior art will permit.
* * * * *