U.S. patent application number 15/958758 was filed with the patent office on 2018-08-23 for graft fixation using a plug against suture.
The applicant listed for this patent is Arthrex, Inc.. Invention is credited to Stephen S. Burkhart, Peter J. Dreyfuss, Neal S. ElAttrache.
Application Number | 20180235598 15/958758 |
Document ID | / |
Family ID | 40568219 |
Filed Date | 2018-08-23 |
United States Patent
Application |
20180235598 |
Kind Code |
A1 |
Burkhart; Stephen S. ; et
al. |
August 23, 2018 |
GRAFT FIXATION USING A PLUG AGAINST SUTURE
Abstract
A method for securing soft tissue to bone which does not require
the surgeon to tie suture knots to secure the tissue to the bone.
Suture is passed through the graft at desired points. A cannulated
plug or screw is pre-loaded onto the distal end of a driver
provided with an eyelet implant at its distal end. Suture attached
to the graft is passed through the eyelet of the implant located at
the distal end of the driver. The distal end of the driver together
with the eyelet implant is inserted into the bone. Tension is
applied to the suture to position the graft at the desired location
relative to the bone. The screw or plug is advanced into the pilot
hole by turning the interference screw or tapping the plug until
the cannulated screw or plug securely engages and locks in the
eyelet implant, so that the cannulated plug or screw with the
engaged eyelet implant is flush with the bone. Once the screw or
plug is fully inserted and the suture is impacted into the bone,
the driver is removed and any loose ends of the sutures protruding
from the anchor site are then clipped short.
Inventors: |
Burkhart; Stephen S.;
(Boerne, TX) ; ElAttrache; Neal S.; (Los Angeles,
CA) ; Dreyfuss; Peter J.; (Naples, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Arthrex, Inc. |
Naples |
FL |
US |
|
|
Family ID: |
40568219 |
Appl. No.: |
15/958758 |
Filed: |
April 20, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
13765218 |
Feb 12, 2013 |
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15958758 |
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|
13182893 |
Jul 14, 2011 |
8430909 |
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|
13765218 |
|
|
|
|
12022868 |
Jan 30, 2008 |
7993369 |
|
|
13182893 |
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|
10405707 |
Apr 3, 2003 |
7329272 |
|
|
12022868 |
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09886280 |
Jun 22, 2001 |
6544281 |
|
|
10405707 |
|
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60213263 |
Jun 22, 2000 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/0811 20130101;
A61B 2017/0409 20130101; A61F 2/0805 20130101; A61B 2017/00907
20130101; A61B 2017/045 20130101; A61B 17/0401 20130101; A61B
2017/0445 20130101; A61F 2002/0858 20130101; A61F 2002/0835
20130101; A61B 17/8645 20130101; A61B 2017/044 20130101; A61B
2017/0403 20130101; A61B 2017/0448 20130101; A61B 2017/0414
20130101; A61F 2002/0852 20130101; A61B 17/8875 20130101; A61F
2002/0888 20130101; A61B 17/864 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61F 2/08 20060101 A61F002/08 |
Claims
1. A method of soft tissue repair, comprising the steps of:
providing a hole in a bone at a location at which a soft tissue
graft is to be affixed; attaching at least one suture to the soft
tissue graft to be affixed; capturing the suture attached to the
graft by feeding the suture through an aperture of an implant, said
implant being releasably attached at a distal end of a driver, the
driver being preloaded with a cannulated interference device on a
shaft of the driver; inserting the suture into the hole by
inserting the distal end of the driver into the hole; pulling on
one end of the suture to draw the suture through the aperture of
the implant such that the soft tissue graft attached to the suture
is drawn toward the hole; and inserting the interference device
into the hole so that the cannulated interference device is
advanced toward the implant to secure the suture in the hole.
2. The method of soft tissue repair according to claim 1, wherein
the interference device is a screw.
3. The method of soft tissue repair according to claim 1, wherein
the interference device is a plug.
4. The method of soft tissue repair according to claim 1, wherein
the aperture has an eyelet configuration.
5. The method of soft tissue repair according to claim 1, wherein
the aperture has a horseshoe-shaped configuration.
6. The method of soft tissue repair according to claim 1, wherein
the aperture is provided with at least one protuberance at its
distal end.
7. The method of soft tissue repair according to claim 1, wherein
the driver includes an outer shaft disposed around an inner shaft
and movable between a proximal position and a distal position along
the inner shaft, and wherein the interference device is preloaded
onto the inner shaft by inserting the inner shaft through a cannula
of the interference device with the outer shaft retracted to the
proximal position so that the proximal end of the loaded
interference device abuts the distal end of the outer shaft.
8. The method of soft tissue repair according to claim 7, wherein
the interference device is a screw having a hex-shaped cannula and
at least a portion of the implant at the distal end of the driver
is hex-shaped to be matingly insertable into the hex-shaped
interference screw cannula.
9. The method of soft tissue repair according to claim 1, wherein
the soft tissue graft is drawn into the hole by pulling on the
suture, and the interference device secures not only the suture but
also the graft in the hole.
10. The method of soft tissue repair according to claim 1, wherein
the interference device is inserted into the hole by impaction.
Description
[0001] This is a continuation of U.S. application Ser. No.
13/765,218, filed Feb. 12, 2013, which is a divisional of U.S.
application Ser. No. 13/182,893, filed Jul. 14, 2011, now U.S. Pat.
No. 8,430,909, which is a continuation of U.S. application Ser. No.
12/022,868, filed Jan. 30, 2008, now U.S. Pat. No. 7,993,369, which
is a continuation-in-part of U.S. application Ser. No. 10/405,707,
filed Apr. 3, 2003, now U.S. Pat. No. 7,329,272, which is a
continuation-in-part of U.S. application Ser. No. 09/886,280, filed
Jun. 22, 2001, now U.S. Pat. No. 6,544,281, which claims the
benefit of U.S. Provisional Application Ser. No. 60/213,263, filed
Jun. 22, 2000.
FIELD OF THE INVENTION
[0002] The present invention relates to methods and instruments for
fixation of sutures and tissue to bone.
BACKGROUND OF THE INVENTION
[0003] When soft tissue such as a ligament or a tendon becomes
detached from a bone, surgery is usually required to reattach or
reconstruct the tissue. Often, a tissue graft is attached to the
bone to facilitate regrowth and permanent attachment. Various
fixation devices, including sutures, screws, staples, wedges, and
plugs have been used in the past to secure soft tissue to bone. For
example, in typical interference screw fixation, the graft is fixed
to the bone by driving the screw into a blind hole or a tunnel in
the bone while trapping the end of the graft between the screw and
the bone tunnel. In other methods, the graft is simply pinned
against the bone using staples or sutures tied around the end of
the graft to the bone.
[0004] U.S. Pat. No. 6,544,281, the disclosure of which is
incorporated by reference herein, discloses a surgical technique
and associated instruments for securing soft tissue to bone which
does not require the surgeon to tie suture knots to secure the
tissue to the bone. According to the technique, a cannulated plug
or screw is pre-loaded onto the distal end of a cannulated driver,
and a suture or wire loop is passed through the cannula of the
driver so that a looped end of the suture or wire is exposed at the
distal end of the driver. Suture strands attached to a graft are
fed through the loop at the end of the driver, and the driver is
inserted into the bottom of the hole, with the screw or plug
disposed just outside the hole. With tension applied to the suture
or wire loop to keep the graft at the desired location relative to
the bone hole, the screw or plug is then fully advanced into the
hole using the driver to frictionally secure either the suture
attached to the graft or the graft itself into the bone hole.
[0005] Although the above-described technique provides an improved
method of graft fixation to bone, the flexible loop configuration
at the end of the driver disadvantageously impedes sliding of the
suture or graft which is fed through the suture loop. In addition,
because the cannulated driver of U.S. Pat. No. 6,544,281 is
provided with a flexible loop at its distal end, placement of the
suture or graft at the bottom of the blind hole or socket and the
cortical bone must be approximated, thus sometimes necessitating
additional removal, tapping and insertion steps to ensure full
insertion of the plug or screw into the blind hole or socket. This,
in turn, may abrade the adjacent tissue and/or damage the bone or
cartilage.
[0006] Accordingly, a need exists for an improved surgical
technique and associated device for securing soft tissue to bone
which allows the free sliding of the suture ends attached to a
graft to ensure the positioning of the graft at an appropriate
distance from the device. A fixation device and associated surgical
technique that allow precise advancement and guiding of the plug or
screw into the blind hole or socket are also needed.
SUMMARY OF THE INVENTION
[0007] The instruments and methods of the present invention
overcome the disadvantages of the prior art, such as those noted
above, by providing an eyelet implant at the distal end of a driver
that securely engages and locks into a cannulated ribbed body of an
interference plug or screw. The eyelet implant includes a fixed
aperture for receiving a suture attached to a graft, such that the
suture is able to freely slide through the aperture.
[0008] In one embodiment of the invention, suture is passed through
the graft at desired points. A cannulated plug or screw is
pre-loaded onto a driver provided with an eyelet implant at its
distal end. Suture attached to the graft is passed through an
aperture of the eyelet implant located at the distal end of the
driver. The distal end of the driver together with the eyelet
implant is inserted directly into the bone. The screw or plug is
fully advanced into the pilot hole by tapping the interference
screw or plug until the cannulated plug or screw securely engages
and locks in the eyelet implant. Once the screw or plug is fully
inserted and the suture is impacted into the bone, the driver is
removed.
[0009] Other features and advantages of the invention will become
apparent from the following description of the invention, which
refers to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 illustrates a perspective view of a distal end of a
push lock driver of the present invention.
[0011] FIG. 2 illustrates a perspective view of a push lock driver
of the present invention.
[0012] FIG. 3 is a schematic cross-sectional view of a surgical
site undergoing a graft fixation technique according to a method of
the present invention.
[0013] FIG. 4 is a schematic view of the surgical site of FIG. 3
undergoing a graft fixation technique with the push lock driver of
FIGS. 1-2.
[0014] FIG. 5 is a schematic view of the surgical site of FIG. 3
undergoing a graft fixation technique with the push lock driver of
FIGS. 1-2 and at a stage subsequent to that shown in FIG. 4.
[0015] FIG. 6 is a schematic view of the surgical site of FIG. 3
undergoing a graft fixation technique with the push lock driver of
FIGS. 1-2 and at a stage subsequent to that shown in FIG. 5.
[0016] FIG. 7 is a schematic view of the surgical site of FIG. 3
undergoing a graft fixation technique with the push lock driver of
FIGS. 1-2 and at a stage subsequent to that shown in FIG. 6.
[0017] FIG. 8 is a schematic view of an eyelet implant of the
present invention secured by and locked into an interference
device, and in accordance with an embodiment of the present
invention.
[0018] FIG. 9 illustrates a perspective view of a distal end of a
push lock driver in accordance with a second embodiment of the
present invention.
[0019] FIG. 10 illustrates a perspective view of a distal end of a
push lock driver in accordance with a third embodiment of the
present invention.
[0020] FIG. 11 illustrates a perspective view of a distal end of a
push lock driver in accordance with a fourth embodiment of the
present invention.
[0021] FIG. 12 illustrates another perspective view of the push
lock driver of FIG. 11 with a strand passed through an aperture of
the push lock.
[0022] FIG. 13 is a schematic cross-sectional view of a surgical
site undergoing a graft fixation technique with the push lock
driver of FIGS. 11 and 12.
[0023] FIGS. 14 and 14A are schematic views of the surgical site of
FIG. 13 at a graft fixation stage subsequent to that shown in FIG.
13.
[0024] FIGS. 15 and 15A are schematic views of the surgical site of
FIG. 13 at a graft fixation stage subsequent to that shown in FIGS.
14 and 14A.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0025] Referring now to the drawings, where like elements are
designated by like reference numerals, FIGS. 1 and 2 illustrate an
implant driver 100 of the present invention. Driver 100 includes a
body 4, preferably in the form of a cylinder, and having a distal
end 12 (FIG. 1) and a proximal end 13 (FIG. 2). The body 4 of
driver 100 includes an outer shaft 17 and an inner shaft 19. The
outer shaft 17 is cannulated for receiving inner shaft 19.
[0026] As illustrated in FIG. 1, driver 100 is pre-loaded with an
interference device 20. Preferably, the interference device 20 is a
screw or an interference plug, preferably formed of a bioabsorbable
material such as PLLA. If a screw is employed, the screw may be
provided with a cannulated body provided with a continuous thread
having rounded outer edges. The head of the screw may be rounded to
minimize abrasion or cutting of tissue. The cannulation formed
through the screw is preferably hex-shaped and accepts the
correspondingly shaped inner shaft 19 of driver 100. If an
interference plug is desired, the plug is provided with rounded
annular ribs separated by rounded annular grooves. The outer
diameter of the ribs and grooves is substantially constant. The
plug tapers significantly toward the distal end. The plug also
comprises a cannula, preferably hex-shaped, for accommodating the
inner correspondingly shaped shaft 19 of the corresponding driver
100.
[0027] As also shown in FIG. 1, an eyelet implant 50 is provided at
the distal end 12 of driver 100. The eyelet implant 50 is
releasably attached to the distal end 12 of driver 100 by means of
a connector 57. The eyelet implant 50 is formed of a transparent
polymer material, and is preferably made of a bioabsorbable
material such as PLLA, polyglycolic or polylactic acid polymers.
Advantageously, the eyelet implant 50 is made of a material similar
to that of the interference device 20. As illustrated in FIG. 1,
the eyelet implant 50 is provided with aperture 55 for receiving a
suture attached to a graft to pass through the eyelet implant 50,
as described in more detail below. The width "w" (FIG. 1) of the
eyelet implant 50 is about equal the diameter of the inner shaft 19
and slightly smaller than the diameter of the outer shaft 17 and of
the cannula of the interference device 20.
[0028] FIG. 2 illustrates proximal end 13 of driver 100, showing a
handle 15 disposed coaxially with the body 4 and outer shaft 17 and
provided with handle slots or protuberances 16. As described below,
handle slots or protuberances 16 allow a suture strand to be
wrapped around the handle 15 and be subsequently tensioned prior to
the impaction of the interference device 20 into the pilot hole. In
this manner, the graft is precisely positioned at an appropriate
distance from the pilot hole, and the suture with the attached
graft is secured at the bottom of the pilot hole and prevented from
exiting the pilot hole.
[0029] A method of a graft fixation technique according to the
present invention is now described with reference to FIGS. 3-8. The
present invention may be used to secure any type of soft tissue,
graft, or tendon, such as, for example, a biceps tendon or a
rotator cuff. FIG. 3 illustrates at least one suture 80 passed
though the graft 70 at desired points. FIG. 3 also illustrates a
pilot hole or socket 90 formed in the bone or cartilage 93 using a
drill or punch, at the location where the tissue is to be secured.
A punch provides the advantages of rounding the opening edge of the
bone socket to protect the sutures 80 attached to the graft 70 from
being sheared during the insertion process, and also compacts the
bone at the punch site for better attachment of the bone by the
anchor in cases where the bone is a soft bone.
[0030] Next, as shown in FIG. 4, driver 100 with a pre-loaded
interference device 20 and with the outer shaft 17 in the retracted
position is provided in the proximity of the bone socket 90.
Sutures 80 attached to the graft 70 are subsequently passed through
the aperture 55 of the eyelet implant 50 at the end of driver 100,
as shown in FIG. 4.
[0031] Referring now to FIG. 5, driver 100 is held with gentle
pressure so that the eyelet implant 50 at the distal end 12 is held
at the bottom of the hole 90, keeping the interference device 20
just outside the pilot hole 90. Tension is then applied to the
suture 80 by wrapping the suture 80 around the slots 16 of the
handle 15 and tensioning it, as shown in FIGS. 6-7. The suture 80
freely slides through aperture 55 of the eyelet implant 50,
allowing the graft 70 to be positioned close to the edge of the
pilot hole 90. Once tensioning of the suture 80 has been completed,
the interference device 20 is then impacted into the pilot hole 90
so that the interference device 20 advances toward the distal end
12 of driver 100 and securely engages and locks in the eyelet
implant 50 with the sutures 80, as shown in FIGS. 7-8. After the
interference device 20 is fully inserted, the driver is removed and
the ends of the sutures can be removed by clipping them short,
leaving the graft 70 securely fastened to bone 93.
[0032] A significant advantage of the present invention is that the
sutures attached to the graft or the graft itself can be securely
attached to the bone without the need to tie knots. Additionally,
the suture attached to the graft is secured both by the eyelet
implant and by the interference device, along the bottom and
sidewalls of the pilot hole between the bone and the screw or plug,
conferring a much stronger fixation of the graft to the bone than
is achievable with prior art procedures and devices. More
importantly, the suture attached to the graft is allowed to freely
slide though the aperture of the eyelet implant to allow precise
advancement and guiding of the plug or screw into the blind hole or
socket.
[0033] In another embodiment of the present invention illustrated
in FIG. 9, driver 200 is provided with a horseshoe-shaped implant
250 (i.e., an implant with an open distal end) at the distal end of
the driver in lieu of the eyelet implant. The horseshoe-shaped
implant 250 is provided in the form of a wedge 255 that allows the
suture attached to a graft to be securely contained within the
wedge, yet be capable to freely slide within the wedge. The
horseshoe-shaped implant 250 is formed of a transparent polymer
material, and is preferably made of a bioabsorbable material such
as PLLA, polyglycolic or polylactic acid polymers. Advantageously,
the horseshoe-shaped implant 250 is made of a material similar to
that of the interference device 20.
[0034] The horseshoe-shaped implant 250 may be detachable from the
distal end 12 of the driver 200, similar to the eyelet implant
described in detail above. In this embodiment, the detachable
horseshoe-shaped implant 250 is securely engaged within the
cannulated ribbed body of the interference plug or screw 20.
Alternatively, the horseshoe-shaped implant 250 may be integral
with the distal end 12 of the driver 200 and, after the
interference screw or plug 20 is fully inserted into the pilot
hole, the horseshoe-shaped implant 250 is removed from the site
together with the driver 200.
[0035] In yet another embodiment of the present invention and as
illustrated in FIG. 10, driver 300 of the present invention is
provided with a metal tubing 350 at the distal end of a driver,
which in turn, is provided with a cut or pair of protuberances 355
at its most distal end to allow at least one end of a suture
attached to a graft to be securely contained within the cut, yet be
capable to freely slide within the cut. Preferably, the metal
tubing 350 is integral with the distal end 12 of the driver 300
and, subsequent to the full insertion of the interference screw or
plug 20 into the pilot hole, the metal tubing 350 is removed from
the site together with the driver 300.
[0036] FIGS. 11-15 illustrate another embodiment of the present
invention, according to which driver 400 is provided with a pointed
tip implant 450 at the distal end of the driver, which is also an
eyelet implant but which, because of its pointed tip, does not
require the pre-drilling or pre-formation of a hole for fixating
the device (implant with suture attached to graft) in the bone. The
conical configuration of the most distal end of the pointed tip
implant 450 allows the driver 400 with the attached implant to
undergo a self-punching operation during graft fixation,
eliminating any need to pre-drill a hole in the bone and providing
increased fixation of the overall operation of securing the soft
tissue. The conical configuration of the most distal end of the
pointed tip implant 450 also provides suture fixation strength, as
well as accelerated graft/tendon healing to bone. The pointed tip
implant 450 may be detachable from the driver.
[0037] As illustrated in FIGS. 11 and 12, pointed tip implant 450
is provided with an eyelet or aperture 455 for receiving at least
one strand (for example, a suture strand) attached to a graft to
pass through the eyelet implant 450. Pointed tip implant 450 is
also provided, at its most distal end, with a conical portion 451
which allows direct advancement of the implant (by simply tapping
the device with a mallet, for example) without the formation of a
bone hole. Preferably, the conical portion 451 of the implant is
formed of titanium or titanium alloy. In a preferred embodiment,
eyelet or aperture 455 is also formed of titanium or similar
material, to withstand impaction forces during the graft fixation
procedure.
[0038] As in the previously-described first embodiment, strand 80
(attached to graft 70) is passed through the aperture 455 of the
implant 450 at the end of the driver 400, as shown in FIGS. 11 and
12. Although FIG. 12 illustrate two strands 80 (i.e., two suture
strands 80) passed through the aperture 455, the invention is not
limited to this exemplary embodiment and contemplates additional
embodiments wherein one strand or any number of strands are passed
through the aperture 455. Preferably, at least one of the strands
is formed of a high strength suture material such as FiberWire.RTM.
suture, sold by Arthrex, Inc. of Naples, Fla., and described in
U.S. Pat. No. 6,716,234, the disclosure of which is incorporated by
reference herein. The high strength suture may be available in
various lengths and widths. FiberWire.RTM. suture is formed of an
advanced, high-strength fiber material, namely ultrahigh molecular
weight polyethylene (UHMWPE), sold under the tradenames Spectra
(Honeywell) and Dyneema (DSM), braided with at least one other
fiber, natural or synthetic, to form lengths of suture material.
The preferred FiberWire.RTM. suture includes a core within a hollow
braided construct, the core being a twisted yarn of UHMWPE. The
suture may optionally include filaments of various colors.
[0039] An exemplary method of graft fixation using the pointed tip
implant 450 of the present invention is illustrated with reference
to FIGS. 13-15. This exemplary method illustrated in FIGS. 13-15
relates to a specific graft fixation technique (i.e., SutureBridge
Lateral Row fixation); however, the invention is not limited to
this exemplary embodiment and applies to any other method of soft
tissue fixation known in the art.
[0040] Referring to FIG. 13, an Arthrex SutureBridge.RTM. medial
row is completed as known in the art and the strands 80 (suture
strands 80) are threaded through the titanium eyelet 455. As shown
in FIG. 14A, a protective cap 94 (or other device that prevents
anchor deployment) is malleted to advance the PushLock.RTM. until
the anchor contacts bone 93. The suture is then tensioned, as shown
in FIG. 14. The protective cap 94 is subsequently removed (FIG.
15A) and the plug 420 is malleted until a mark (for example, a
predefined laser line) is flush with the bone (FIG. 15). The
ribbed, spiked configuration of plug 420 facilitates the insertion
of the device 400 into the bone by simply exerting force upon the
device, without the need to drill or form a hole in the bone.
[0041] Although the above embodiments have been described with
reference to an implant, such as eyelet implant 50, 450 (FIGS. 1
and 11) or horseshoe-shaped implant 250 (FIG. 9), for example,
having an aperture of a predefined configuration (i.e., eyelet or
horseshoe configuration), it should be understood that the
invention is not limited to these embodiments. Accordingly, the
present invention also contemplates implants affixed to or
detachable from a preloaded driver and having an aperture of any
configuration or geometrical shape, as long as it captures suture
and allows the captured suture to freely slide within the
aperture.
[0042] 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, but
only by the appended claims.
* * * * *