U.S. patent application number 12/418391 was filed with the patent office on 2009-07-23 for fenestrated swivel anchor for knotless fixation of tissue.
This patent application is currently assigned to Arthrex, Inc.. Invention is credited to Peter J. Dreyfuss, Reinhold Schmieding, John A. Sodeika.
Application Number | 20090187216 12/418391 |
Document ID | / |
Family ID | 42174025 |
Filed Date | 2009-07-23 |
United States Patent
Application |
20090187216 |
Kind Code |
A1 |
Schmieding; Reinhold ; et
al. |
July 23, 2009 |
FENESTRATED SWIVEL ANCHOR FOR KNOTLESS FIXATION OF TISSUE
Abstract
A method and device for knotless fixation of tissue. A swivel
anchor having a rotatable implant is used to capture suture for
surgical tissue repair without requiring suture knots. The implant
may be provided with a conical metal tip which is self-punching and
avoids the need for pre-drilling a hole in bone. The implant
includes a closed aperture to allow free sliding of a suture
strand. The swivel anchor is secured in a hole in bone by advancing
a fenestrated fixation device, such as a cannulated interference
screw, over the body of the implant.
Inventors: |
Schmieding; Reinhold;
(Naples, FL) ; Dreyfuss; Peter J.; (Naples,
FL) ; Sodeika; John A.; (Naples, FL) |
Correspondence
Address: |
DICKSTEIN SHAPIRO LLP
1825 EYE STREET NW
Washington
DC
20006-5403
US
|
Assignee: |
Arthrex, Inc.
|
Family ID: |
42174025 |
Appl. No.: |
12/418391 |
Filed: |
April 3, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12368946 |
Feb 10, 2009 |
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12418391 |
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12043008 |
Mar 5, 2008 |
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12368946 |
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11802057 |
May 18, 2007 |
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12043008 |
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60801097 |
May 18, 2006 |
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Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0438 20130101;
A61F 2002/0858 20130101; A61B 2017/0459 20130101; A61F 2/0805
20130101; A61B 2017/0445 20130101; A61F 2002/0852 20130101; A61B
17/0401 20130101; A61F 2002/0888 20130101; A61B 2017/0409 20130101;
A61B 2017/0414 20130101; A61F 2002/0817 20130101; A61B 2017/044
20130101; A61F 2/0811 20130101; A61F 2002/0841 20130101; A61B
2017/0458 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A method of tissue fixation comprising: providing a suture;
securing the suture to the tissue to be fixated; and anchoring the
suture into the bone socket using a swivel implant and a fixation
device provided with side fenestrations, thereby providing tissue
fixation.
2. The method of claim 1, wherein the fixation device is an
cannulated interference screw or a cannulated plug.
3. The method of claim 1, wherein the swivel implant has a conical
portion terminating at a pointed tip at its most distal end.
4. The method of claim 1, wherein the swivel implant has a closed
aperture at its distal end.
5. The method of claim 1, further comprising the step of capturing
the suture attached to the graft with the swivel implant.
6. The method of claim 5, wherein the step of capturing the suture
further comprises passing the suture through a closed aperture of
the swivel implant.
7. The method of claim 6, wherein the closed aperture has an eyelet
configuration.
8. The method of claim 1, further comprising the steps of
preloading the fixation device on a driver and, subsequently,
providing the swivel implant at a distal end of the driver.
9. A suture anchor comprising: an anchor body provided with side
fenestrations; and an anchor tip rotatably attached to the anchor
body.
10. The suture anchor of claim 9, wherein the anchor tip has a
closed aperture.
11. The suture anchor of claim 9, wherein the anchor tip is a metal
tip.
12. The suture anchor of claim 9, wherein the suture anchor is
configured to allow rotational insertion without causing excessive
twisting and knotting of a suture captured in the anchor tip.
13. The suture anchor of claim 9, wherein the anchor tip is
configured to capture a suture.
14. The suture anchor of claim 9, wherein the anchor body has a
cylindrical configuration.
15. The suture anchor of claim 9, wherein the anchor tip is
detachable.
16. The suture anchor of claim 9, further comprising a fixation
device for securing the suture anchor in bone.
17. The suture anchor of claim 16, wherein the fixation device is a
cannulated interference screw or a plug.
18. The suture anchor of claim 17, wherein the fixation device is a
cannulated device.
Description
[0001] This application is a continuation-in-part of application
Ser. No. 12/368,946, filed on Feb. 10, 2009, which is a CIP of
application Ser. No. 12/043,008, filed on Mar. 5, 2008, which in
turn is a continuation-in-part of application Ser. No. 11/802,057,
filed on May 18, 2007, which claims the benefit of Provisional
Application Ser. No. 60/801,097, filed on May 18, 2006, the entire
disclosures of which are incorporated herein by reference.
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 tears away from bone, reattachment becomes
necessary. Various devices, including sutures, screws, staples,
wedges, anchors and plugs have been used in the prior art to secure
soft tissue to bone. Surgical methods utilizing suture anchors
alone are disadvantageous for reattachment of large areas of
detached tissue because they often do not allow good tissue to bone
contact.
[0004] Reattachment of soft tissue to bone typically requires the
surgeon to pass suture material through selected tissue, form a
plurality of surgical knots extracorporeally and then move the
knots into position adjacent the desired tissue to be sutured. In
such procedures, the surgeon must manually tie the knots on the
suture strands after the suture is threaded through the selected
tissues to be sutured. Knot tying during surgery, particularly
arthroscopic surgery, is tedious and time-consuming. There is also
a tendency for the knots to deform or collapse as the surgeon
manually forces the knots down into the proper position. Also, the
suture knots often are exposed to abrasion or cutting by sharp or
rough areas along the walls of the bone canal into which anchors
are typically inserted to provide fixation of tendon to bone.
[0005] Accordingly, a need exists for an improved method for
attaching soft tissue to bone which does not require multiple
suture knots and which allows the tendon to remain securely in
place until the ligaments naturally attach to bone. A need also
exists for such a knotless method of attaching tissue to bone which
employs an implant with a fenestrated configuration that promotes
healing of tissue.
SUMMARY OF THE INVENTION
[0006] The instruments and methods of the present invention
overcome the disadvantages of the prior art, such as those noted
above, by providing a swivel 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 swivel implant includes a closed
aperture for receiving a strand attached to a graft, such that the
strand is able to freely slide through the aperture.
[0007] In one embodiment of the invention, the strand is passed
through the graft at desired points. A cannulated plug or screw is
pre-loaded onto a driver provided with a swivel lock twist-in
anchor at its distal end. The strand attached to the graft is
passed through the aperture of the swivel implant located at the
distal end of the driver. The distal end of the driver together
with the implant is inserted directly into the bone. The driver may
be rotated (in a clockwise direction, for example) to advance a
screw over the anchor to complete insertion. The cannulated plug or
screw is provided with a plurality of openings or fenestrations of
various dimensions and geometries to provide multiple pathways
through the device (i.e., though the interior of the body and
through the fenestrations) to allow blood to flow to increase the
healing zone, for example, for rotator cuff repair, while also
promoting bone in-growth.
[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. 1-6 depict a series of steps of shoulder repair using
a plurality of swivel anchor devices according to the present
invention.
[0010] FIG. 7 illustrates various views of the driver assembly of
the present invention.
[0011] FIGS. 8 and 9 illustrate the swivel implant and traction
suture.
[0012] FIG. 10 is an enlarged view of the fixation device
(cannulated screw) used in the present invention.
[0013] FIG. 11 illustrates various views of a swivel anchor with a
metal tip which avoids the need to pre-drill a hole in bone.
[0014] FIGS. 12 and 13 provide additional illustrations of the
swivel anchor assembly of the present invention, and the swivel
anchor inserted in a bone socket, respectively.
[0015] FIGS. 14-16 illustrate various views of a fixation device
with fenestrations and used in conjunction with the swivel anchor
assembly of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0016] The present invention provides apparatus and methods for
knotless tissue fixation using a swivel anchor device.
[0017] FIG. 1 illustrates a side view of a human shoulder of a
patient undergoing a rotator cuff repair in accordance with an
exemplary embodiment of the present invention. The patient may be
positioned in the beach chair position using the Arthrex Beach
Chair Lateral Traction Device or in a lateral decubitus position
using the Arthrex 3-Point Shoulder Distraction System. Access to
the subacromial space is facilitated with a variety of
cannulas.
[0018] First, and as illustrated in FIG. 1, the mobility of the
tear is assessed using, for example, a tissue grasper 10 such as
the Arthrex KingFisher.TM. Suture Retriever/Tissue Grasper, to
determine whether a U or L-shaped component exists. Where large
tears extend to the superior aspect of the glenoid, margin
convergence suturing is performed to reduce volume and strain on
the repair. Subsequently, the length and width of the rotator cuff
footprint is assessed and a bleeding bed for enhanced tendon to
bone healing may be formed. This may be accomplished with a burr to
perform a light dusting of the greater tuberosity, or by using a
chondro pick to microfracture the footprint and maximize vascular
channels.
[0019] FIG. 2 illustrates the preparation of two pilot holes for
two swivel anchors that will be inserted in the medial row. A punch
may be employed adjacent to the articular margin of the humerus and
at about 45.degree. angle to form the two pilot holes.
[0020] Subsequent to the formation of the pilot holes, and as shown
in FIGS. 3 and 4, a swivel implant 30, loaded with a strand of
suture tape 40, preferably Arthrex FiberTape, is placed in the
medial pre-formed hole 32. Arthrex FiberTape is a high strength
suture tape which is braided and rectangular-like in cross section
and is disclosed in U.S. Patent Application Publication No.
2005/0192631, the disclosure of which is incorporated by reference
herein. However, the anchor of the present invention can be used
with any type of flexible material or suture. The driver is then
rotated to advance screw 42 down shaft 20 to secure the implant and
suture in the bone hole. More specifically, as shown in FIG. 4a,
the screw 42 is advanced by holding thumb pad 50 as the driver
handle 22 is turned clockwise. An Arthrex FiberLink and an Arthrex
Scorpion suture passer 44, are used to shuttle both tails of the
suture tape through the rotator cuff 34 simultaneously. This
procedure is followed for both medial swivel anchors.
[0021] Referring to FIG. 5, one tail of suture tape 40 from each
medial swivel anchor is retrieved and loaded through the eyelet of
another swivel implant 30, and that implant is installed in then
inserted into a preformed lateral bone socket. The tension of the
suture tape 40 is adjusted if necessary. The swivel anchor driver
is then rotated in clockwise direction as before to advance the
screw 42 over the implant to complete insertion. This step is
repeated in another lateral bone socket with the other tails of
suture tape from each medial anchor. The tails of the suture tape
40 are then cut, one at a time, to complete the construct as shown
in FIG. 6. The method is analogous to the method disclosed in U.S.
Patent Application Publication No. 2007/0191849, the entire
disclosure of which is incorporated by reference herein. FIGS. 12
and 13 provide additional illustrations of the swivel anchor
assembly and the anchor inserted in a bone socket,
respectively.
[0022] The swivel anchor and instruments of the present invention
are now described in greater detail. As shown in FIGS. 7(a)-(f), a
driver 68 is used to install the knotless fixation devices with a
swiveling implant. Driver 68 features a thin cannulated rod 20
passing slidably and rotatably through a cannulated driver
assembly. The tip of thin cannulated rod 20 is adapted to accept
swivel anchor implant 42 within the cannulation at its tip,
preferably via a snap fit. Cannulated rod 20 has a hexagonal outer
surface for receiving anchor body (preferably a screw) 42 having a
corresponding cannulation. FIG. 10 illustrates a detailed view of
the cannulated screw 42.
[0023] During installation of the knotless anchor having a
swiveling implant 30, the screw 42 is first inserted onto
cannulated rod 20 of the driver 68. As shown in FIGS. 7(a) and (b),
screw 42 is loaded onto rod 20 and then fully seated on the shaft
end of the driver. FIG. 7(c) illustrates the swivel anchor implant
30. As shown in FIGS. 8-9, traction sutures 71 extending from the
proximal end of the swivel anchor implant 30 are threaded through
the cannulation of the driver 68 (see also FIG. 7(c)). These
traction sutures 71 prevent inadvertent separation of the implant
30 from the driver during insertion, but they can be used
subsequently for additional tie-down of the tendon after the driver
is removed. Subsequently, the swivel anchor implant 30 is seated on
the driver tip and until advanced until it snaps onto place (FIG.
7(d)). A protective tube 94 (FIG. 7(e)) may be placed over the tip
of the assembly for shipping purposes. The traction sutures 71 may
be looped around the driver handle, as shown in FIGS. 7(f) and (g),
and secured in a cleat 98 to prevent the implant 200 from becoming
prematurely detached from the driver.
[0024] The knotless fixation device of the present invention
advantageously minimizes or eliminates the need to tie knots. The
use of such a swivel anchor also provides secure fixation of the
suture construct--the secure suture construct results from the
suture being pushed into a hole and held tightly by an anchors.
[0025] In the preferred embodiment of the present invention, as
mentioned above, suture tape is used with the swivel anchor to fix
tissue to bone. However, the swivel anchor of the present invention
can be used with any type of flexible material or suture. In
another preferred embodiment, an allograft or biological component
may be used instead of suture or tape. The allograft or biological
component may be comprised of tendon or pericardium, for example,
which provides improved tissue repair. In yet additional
embodiments, any combination of suture, suture tape, and allograft
or biological component may be employed, depending on the
characteristics of the specific surgical repair and/or as
desired.
[0026] FIG. 11 illustrate a swivel implant 500 which is provided
with a pointed metal tip to facilitate insertion of the implant
without the need to pre-drill or pre-form a hole in the bone. The
conical configuration of the most distal end pointed tip 550 allows
the implant to undergo a self-punching operation, eliminating any
need to pre-drill a hole in the bone. The conical configuration of
the most distal end of the pointed tip implant 550 also provides
suture fixation strength, as well as accelerated graft/tendon
healing to bone. The pointed tip implant 550 may be detachable from
the driver.
[0027] As illustrated in FIGS. 11(a)-(e), pointed tip implant 500
is provided with a metal tip 550 and an eyelet or aperture 555 for
receiving suture or suture tape. Pointed tip implant 550 is also
provided, at its most distal end, with a conical portion 551 which
allows direct advancement of the implant (by simply tapping the
device with a mallet, for example) without the formation of a pilot
hole in bone. Preferably, the conical portion 551 of the implant is
formed of titanium or titanium alloy. In a preferred embodiment,
eyelet or aperture 555 is also formed of titanium or similar
material, to withstand impaction forces during the graft fixation
procedure.
[0028] FIGS. 14-16 illustrate various views of another exemplary
fixation device 600 of the present invention that is employed in
conjunction with the driver assembly 68 and a swivel anchor or
implant of the present invention (such as the swivel anchor implant
30 or the swivel implant 500 described above). The fixation device
600 is similar to the fixation device (swivel anchor implant) 42 of
FIG. 10, but differs from it in that the fixation device 600 is
provided with a plurality of openings or fenestrations 605 provided
on the outer surface of the body of the device. The openings or
fenestrations 605 may have various dimensions and geometries
provide multiple pathways for w blood to pass through the device
(i.e, through the fenestrations and up through the cannulation)
and, therefore, to the repair site to promote healing. The
fenestrations also promote in-growth of bone. The decreased mass of
the device 600 (resulting from the fenestrations) further promotes
healing and in-growth.
[0029] Preferably, the fixation device 600 is preloaded on the
driver 68. As described above with reference to the three exemplary
embodiments, the fixation device 600 is advanced into the bone
socket by holding the thumb pad 50 as the driver handle 22 is
turned clockwise. When the fixation device 600 is fully seated, the
shaft of the anchor implant 30 or the swivel implant 500 is fully
engaged by the fixation device 600 to optimize the stability of the
swivel anchor construct (composed of swivel anchor or implant 30,
500 and fixation device 600).
[0030] As illustrated in FIGS. 14-16, the fixation device 600
includes a cannulated body 612 in the form of a tapered cylinder
having a proximal end 613 and a distal end 615. A continuous thread
620 wraps around cannulated body 612 in a clockwise direction, as
shown. As shown in FIG. 15, the distal end 615 of the interference
screw 600 terminates in an exposed, flat surface provided with an
opening 616. The proximal end 613 of the interference screw 600
terminates in a drive socket 617 that allows a driver to seat
snuggly in the drive socket to allow manipulation and installation
of the interference screw into the bone socket, while fully
engaging the shaft of the swivel anchor 30 or swivel implant 500
(as detailed above with reference to interference screw 42). As
shown in FIG. 16, drive socket 617 may be configured to be used
with a traditional hex drive screwdriver. Although the drive socket
617 has been described as having hexagonal shape, the drive socket
may also have a Delta drive configuration or a cruciform shape,
among others, that allows the driver to rotationally engage the
interference screw, to turn simultaneously with the driver.
[0031] The fixation device 600 of the present invention may be
formed of a biocompatible and/or biosorbable material. Preferably,
screw 600 is formed of a bioabsorbable material, such as
poly-(L-lactic acid) (PLLA), poly-(D,L-lactide), and poly glycolic
acid (PGA), for example, or other bioabsorbable, non-metallic
materials, which may be especially tailored for hardness, tensile
strength and compressive strength. Alternatively, fixation device
600 may be formed of titanium, titanium alloy, stainless steel or
stainless steel alloy. Other biocompatible materials which could be
used include plastics, allograft bone and inert bone substitute
materials.
[0032] A growth material may be advanced through the cannulated
driver and into the screw 600 by employing a plunger, for example.
As the driver is pulled out, the plunger pushes the flow material
through the cannulation of the driver and into the body of the
screw 600. The growth material will subsequently harden to allow
better fixation of the interference screw 600 against the bone and
the shaft of the swivel anchor 30 or swivel implant 500.
[0033] The growth material may be any solid, semi-solid, viscous,
flowable, gel or elastic composition or mixture that allows its
easy manipulation and insertion into the body 612 of the
interference screw 600. The growth material may contain growth
factors such as autogenous growth factors, for example
platelet-rich plasma (PRP), optionally in combination with
hyaluronic acid (HY acid) and/or with a coagulant such as
thrombin.
[0034] The term "growth factor" as used in the present application
is intended to include all factors, such as proteinaceous factors,
for example, which play a role in the induction or conduction of
growth of bone, ligaments, cartilage or other tissues associated
with bone or joints. In particular, these growth factors include
bFGF, aFGF, EGF (epidermal growth factor), PDGF (platelet-derived
growth factor), IGF (insulin-like growth factor), TGF-.beta.. I
through III, including the TGF-.beta.. superfamily (BMP-1 through
12, GDF 1 through 12, dpp, 60A, BIP, OF).
[0035] Optionally, the growth material may comprise additional
osteoconductive bone adhesives, calcium carbonate, fatty acids,
lubricants, antiseptic chemicals and/or antibiotics. In this case,
other solution excipients such as buffer salts, sugars,
anti-oxidants and preservatives to maintain the bioactivity of the
growth material and a proper pH of the growth material may be also
employed. The additional lubricants and/or the antiseptic and/or
the antibiotic will typically be present in the growth material in
a predetermined concentration range, which will be dependent upon
the particular bone site and application, as well as the specific
activity of the antiseptic and/or the antibiotic.
[0036] 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.
* * * * *