U.S. patent application number 10/391457 was filed with the patent office on 2004-01-22 for endobutton continuous loop for bone-tendon-bone.
This patent application is currently assigned to Smith & Nephew, Inc., a Delaware Corporation. Invention is credited to Bojarski, Raymond A., Fromm, Stuart E., Torrie, Paul.
Application Number | 20040015171 10/391457 |
Document ID | / |
Family ID | 25330022 |
Filed Date | 2004-01-22 |
United States Patent
Application |
20040015171 |
Kind Code |
A1 |
Bojarski, Raymond A. ; et
al. |
January 22, 2004 |
Endobutton continuous loop for bone-tendon-bone
Abstract
A method of securing a tissue graft within a bone passage
includes providing a graft fixation member comprising a closed-loop
having a pair of opposing loop sections and capturing a first loop
section of the closed-loop within the fixation member. An opposing
second loop section of the closed loop is passed through an opening
in the tissue graft, and the second loop section of the closed loop
is secured to the fixation member.
Inventors: |
Bojarski, Raymond A.;
(Attleboro, MA) ; Torrie, Paul; (Marblehead,
MA) ; Fromm, Stuart E.; (Rapid Lake City,
SD) |
Correspondence
Address: |
FISH & RICHARDSON PC
225 FRANKLIN ST
BOSTON
MA
02110
US
|
Assignee: |
Smith & Nephew, Inc., a
Delaware Corporation
|
Family ID: |
25330022 |
Appl. No.: |
10/391457 |
Filed: |
March 18, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10391457 |
Mar 18, 2003 |
|
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09859096 |
May 16, 2001 |
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6533802 |
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Current U.S.
Class: |
606/232 ;
606/228; 623/13.11 |
Current CPC
Class: |
A61F 2002/0852 20130101;
A61F 2002/087 20130101; A61B 2017/0459 20130101; A61F 2002/0882
20130101; A61F 2/0811 20130101; A61B 2017/0404 20130101; A61B
17/0401 20130101 |
Class at
Publication: |
606/72 |
International
Class: |
A61B 017/56 |
Claims
What is claimed is:
1. A method of securing a tissue graft within a bone passage
comprising: providing a graft fixation member comprising a
closed-loop having a pair of opposing loop sections; capturing a
first loop section of the closed-loop within the fixation member
passing an opposing second loop section of the closed loop through
an opening in the tissue graft; and securing the second loop
section of the closed loop to the fixation member.
2. The method of claim 1 further comprising forming the opening in
the tissue graft.
3. The method of claim 2 wherein the opening is formed in a bone
block of the tissue graft.
4. The method of claim 2 wherein the opening is formed in a tendon
of the tissue graft.
5. The method of claim 1 further comprising passing the fixation
member through the bone passage.
6. The method of claim 5 wherein passing the fixation member
through the bone passage comprises first passing the fixation
member through a bone passage in a tibia and then through a bone
passage in a femur.
7. The method of claim 5 wherein passing the fixation member
through the bone passage comprises first passing the fixation
member through a bone passage in a femur and then through a bone
passage in a tibia.
8. The method of claim 1 further comprising positioning the
fixation member to pass through the bone passage using a
suture.
9. The method of claim 1 further comprising positioning the
fixation member to pass through the bone passage using closure
tape.
10. A method of securing a tissue graft within a bone passage
comprising: providing a graft fixation member comprising a closed
loop having a pair of opposing loop sections; capturing a first
loop section of the closed loop within the fixation member; forming
a bight in the closed loop by passing an opposing second loop
section of the of the closed loop through an opening in the tissue
graft; and passing the fixation member and the first loop section
through the bight in the closed loop to capture the tissue
graft.
11. The method of claim 10 further comprising forming the opening
in the tissue graft.
12. The method of claim 11 wherein the opening is formed in a bone
block of the tissue graft.
13. The method of claim 11 wherein the opening is formed in a
tendon of the tissue graft.
14. The method of claim 10 further comprising passing the fixation
member through the bone passage.
15. The method of claim 14 wherein passing the fixation member
through the bone passage comprises first passing the fixation
member through a bone passage in a tibia and then through a bone
passage in a femur.
16. The method of claim 14 wherein passing the fixation member
through the bone passage comprises first passing the fixation
member through a bone passage in a femur and then through a bone
passage in a tibia.
17. The method of claim 10 further comprising positioning the
fixation member to pass through the bone passage using a
suture.
18. The method of claim 10 further comprising positioning the
fixation member to pass through the bone passage using closure
tape.
19. A method of securing a tissue graft within a bone passage
comprising: providing a first graft fixation member and a second
graft fixation member and a closed loop having a pair of opposing
loop sections; capturing a first loop section of the closed loop
within the first graft fixation member; passing an opposing second
loop section through an opening in the tissue graft; and capturing
the second loop section of the closed loop of suture within the
second graft fixation member.
20. The method of claim 19 further comprising forming the opening
in the tissue graft.
21. The method of claim 20 wherein the opening is formed in a bone
block of the tissue graft.
22. The method of claim 20 wherein the opening is formed in a
tendon of the tissue graft.
23. The method of claim 19 wherein the second loop section is
captured within the second fixation member before the second loop
section is passed through the opening in the tissue graft.
24. The method of claim 23 wherein passing the second loop section
through the opening in the tissue graft comprises passing the
second fixation member through the opening.
25. A device for securing a tissue graft within a passage within a
bone comprising: a member comprising an intermediate portion and an
end portion; said end portion comprising a pair of arms extending
from the intermediate portion and defining an open channel at said
end portion; and each arm comprising an opening extending from a
first side of the arm to a second side of the arm, the opening
being sized to accommodate a strand of suture.
26. The device of claim 25 wherein one or more openings pass
through the intermediate portion of the member.
27. The device of claim 26 wherein the openings are
cylindrical.
28. The device of claim 25 wherein the opening in each arm is
cylindrical.
29. The device of claim 25 wherein the openings in each pair of
arms occupy different positions on a common axis.
30. The device of claim 29 wherein the axis is transverse to the
member.
31. The device of claim 25 wherein the pair of arms define a
cylindrical portion of the channel having a diameter equal to the
width of the channel.
32. The device of claim 25 wherein each pair of arms define a
cylindrical portion of the channel having a diameter greater than
the width of the channel.
33. The device of claim 25 wherein the arms are shaped to pass
through bone passage.
34. The device of claim 25 wherein the member is sized to pass
through a bone passage.
35. The device of claim 25 wherein the member comprises a
bio-compatible material.
36. The device of claim 25 wherein the member comprises
titanium.
37. The device of claim 25 wherein the member comprises a
bio-absorbable material.
Description
TECHNICAL FIELD
[0001] This invention relates to anchoring tissue grafts.
BACKGROUND
[0002] An increasing number of surgical techniques are now
performed arthroscopically. One type of arthroscopic procedure
reconstructs the anterior cruciate ligament (ACL) in the knee.
Several ACL reconstruction techniques are described in U.S. Pat.
No. 5,139,520 (issued Aug. 18, 1992) ("the '520 patent") and
incorporated by reference.
[0003] When the ACL has ruptured and is nonrepairable, it is
usually replaced in the knee using a substitute graft harvested
from the patient or from a donor. The substitute ACL graft may be a
portion of a patellar tendon having so called "bone blocks" at each
end. A method and an apparatus for harvesting such a patellar
tendon graft is described in U.S. Pat. No. 5,733,289 (issued Mar.
31, 1998) ("the '289 patent") and incorporated by reference.
Alternatively, an artificial graft formed from synthetic materials
or from a combination of artificial and natural materials may be
used and is sometimes referred to as a ligament augmentation device
(LAD). The term "tissue graft" is used herein to encompass all of
these tissue replacement items.
[0004] In general, the replacement tissue graft is implanted by
securing one end of the tissue graft in a socket formed in a
passage formed within the femur (i.e., femoral channel) and passing
the other end of the graft through a passage formed in the tibia
(i.e., tibial channel). Then, the graft is secured to the tibia
adjacent to the tibial channel. Generally, sutures are used to
affix each end of the tissue graft to a fastener (e.g., an
interference screw or a post), which is then secured to the bone.
Descriptions of these fasteners and methods of forming the passages
through the tibia and femur are described in greater detail in the
'520 patent.
[0005] Another approach for affixing a tissue graft is described in
U.S. Pat. No. 5,306,301, (issued Apr. 26, 1994) ("the '301 patent")
and incorporated by reference. The '301 patent discloses using a
fixation button to secure a tissue graft at the femoral cortex. The
fixation button has an elongated shape and at least one pair of
openings through which a suture may be passed and then tied
off.
[0006] In this approach, the femoral channel has a portion having a
first diameter sized to accommodate a bone block and a second
portion having a smaller diameter through which the bone block
cannot pass. By measuring the total length of the femoral channel
and the length of the larger portion, the surgeon determines a
"suture span" for attaching the fixation button to the tissue
graft.
[0007] The surgeon forms an opening in the bone block to be
positioned in the femoral channel and threads an end of suture
through it. The surgeon then ties the suture to the fixation
button, providing the suture span between the button and the bone
block. The fixation button and the tissue graft are then passed
through the tibial and femoral channels until the graft is properly
seated within the socket portion of the femoral passage and the
fixation button is firmly seated against the femoral cortex. The
tissue graft is then tensioned and anchored at its opposite end
using a fixation screw secured within the tibia.
[0008] Still another approach for affixing a tissue graft is
described in U.S. Pat. No. 5,769,894, (issued Jun. 23, 1998) ("the
'894 patent") and incorporated by reference. The '894 patent
describes a graft fixation member configured to allow the length of
the suture between the fixation member and the graft to be adjusted
and to maintain the adjusted length when the suture is secured to
the graft fixation member.
[0009] An alternative to tying a suture to a fixation button is
disclosed in PCT Application WO 99/47079 (published Sep. 23, 1999)
("the '079 application") and incorporated by reference. The '079
application discloses an apparatus and method for attaching a
continuous loop of suture to a fixation button. Using a series of
rollers, the continuous loop is formed from a strand of suture
repeatedly coiling the suture through openings in a fixation
button. In other examples, a continuous loop of suture may be
formed without a fixation member. Continuous loops, both with and
without fixation buttons attached, are available from Xiros
Limited, Leeds, England, in several sizes. A surgeon selects the
closest matching size for a given ACL reconstruction procedure. In
other examples, a continuous loop of suture may be formed without a
fixation member.
SUMMARY
[0010] In an aspect, the invention features a method for securing a
tissue graft within a bone passage. A graft fixation member
comprising a closed-loop having a pair of opposing loop sections is
provided and a first loop section of the closed loop is captured
within the fixation member. An opposing second loop section of the
closed loop is passed through an opening in the tissue graft and is
secured to the fixation member.
[0011] In another aspect, the invention features a method of
securing a tissue graft within a bone passage including providing a
graft fixation member comprising a closed loop having a pair of
opposing loop sections. A first loop section of the closed loop is
captured within the fixation member. A bight is formed in the
closed loop by passing an opposing second loop section of the
closed loop through an opening in the tissue graft. The fixation
member and the first loop section are passed through the bight in
the closed loop to capture the tissue graft.
[0012] In another aspect, the invention features a method of
securing a tissue graft within a bone passage including providing a
first graft fixation member and a second graft fixation member and
a closed loop having a pair of opposing loop sections. A first loop
section of the closed loop is captured within the first graft
fixation member and an opposing second loop section is passed
through an opening in the tissue graft. A second loop section of
the closed loop of suture is captured within the second graft
fixation member.
[0013] One or more of the following features may also be included.
The opening is formed in the tissue graft. The opening is formed in
a bone block of the tissue graft. The opening is formed in a tendon
of the tissue graft. The fixation member is passed through the bone
passage. The fixation member through a bone passage in a tibia and
then through a bone passage in a femur. The fixation member is
first passed through a bone passage in a femur and then through a
bone passage in a tibia. The fixation member is positioned to pass
through the bone passage using a suture. The fixation member is
positioned to pass through the bone passage using closure tape. The
second loop section is captured within the second fixation member
before the second loop section is passed through the opening in the
tissue graft. Passing the second loop section through the opening
in the tissue graft includes passing the second fixation member
through the opening.
[0014] In another aspect, the invention features a device for
securing a tissue graft within a passage within a bone. The device
includes a member having an intermediate portion and an end
portion. The end portion has a pair of arms extending from the
intermediate portion and defining an open channel at the end
portion. Each arm has an opening extending from a first side of the
arm to a second side of the arm, the opening being sized to
accommodate a strand of suture.
[0015] One or more of the following features may also be included.
One or more openings pass through the intermediate portion of the
member. The openings are cylindrical. The opening in each arm is
cylindrical. The openings in each pair of arms occupy different
positions on a common axis. The axis is transverse to the member.
The pair of arms define a cylindrical portion of the channel having
a diameter equal to the width of the channel. Each pair of arms
define a cylindrical portion of the channel having a diameter
greater than the width of the channel. The arms are shaped to pass
through bone passage. The member is sized to pass through a bone
passage. The member comprises a bio-compatible material. The member
comprises titanium. The member comprises a bio-absorbable
material.
[0016] Embodiments may have one or more of the following
advantages. The closed loop may be manufactured and purchased
separate from the fixation member. This allows the surgeon the
flexibility to choose the correct size closed loop from several
sizes available in the operating room without a fixation member on
each size loop. In turn, the patient benefits from the reliability
of the closed loop without the added cost of multiple fixation
members. The closed loop is positively captured within the fixation
member during implantation. The closed loop provides superior
strength over single loops of tied suture or tape and does not
extend a patient's time under anesthesia while a surgeon forms
multiple loops of suture or tape by hand. The closed loop may be
pre-stressed during the manufacturing process to reduce its
elasticity and increase its strength without accommodation for a
fixation member.
[0017] The details of one or more embodiments of the invention are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
DESCRIPTION OF DRAWINGS
[0018] FIG. 1 shows an example of a tissue graft being implanted
during an ACL reconstruction procedure using a closed-loop suture
and a graft fixation member.
[0019] FIG. 2 is an example of the graft fixation member.
[0020] FIG. 3 shows an exploded partial view of how closed-loop
suture could be inserted into tissue graft.
[0021] FIG. 4 is an example of a graft-loop assembly before being
attached to the graft fixation member.
[0022] FIG. 5 shows an exploded partial view of a graft-loop
assembly partially captured by the graft fixation member.
[0023] FIG. 6 shows an exploded partial view of a graft-loop
assembly fully captured by the graft fixation member.
[0024] FIG. 7 shows the graft fixation member positioned for
implantation.
[0025] FIG. 8 shows the tissue graft implanted in a knee and
secured at one end by the graft fixation member.
[0026] FIG. 9 shows an alternative example of a graft fixation
member.
[0027] FIG. 10 shows a second alternative example of a graft
fixation member.
[0028] FIG. 11 shows a third alternative example of a graft
fixation member.
[0029] FIG. 12 shows a fourth alternative example of a graft
fixation member and a method for capturing first and second
portions of a closed-loop suture.
[0030] FIG. 13 shows a fifth alternative example of a graft
fixation member and a method of attaching it to a tissue graft
using a closed-loop suture.
[0031] FIG. 14 shows a sixth alternative example of a graft
fixation member and method of attaching it to a tissue graft using
a closed loop suture.
[0032] FIGS. 15-17 show an alternative method for attaching a graft
fixation member to a tissue graft using a closed-loop suture.
[0033] FIGS. 18A-18D show a second alternative method for attaching
a graft fixation member to a tissue graft using a closed-loop
suture.
[0034] FIG. 19 shows an alternative example of a closed loop
suture.
[0035] FIG. 20 shows a third alternative method for attaching a
graft fixation member to a tissue graft using a closed-loop
suture.
DETAILED DESCRIPTION
[0036] Referring to FIG. 1, a tissue graft 20 is shown being
implanted within a knee 10 during an anterior cruciate ligament
(ACL) repair and reconstruction procedure. In one example, tissue
graft 20 has bone blocks on both ends sized and shaped to fit
within femoral and tibial channels, respectively. More
specifically, one end of tissue graft 20 includes a bone block 22
shaped and sized in substantial conformity with a femoral channel
14 of femur 12 while the other end of tissue graft 20 includes a
bone block 24 shaped and sized in substantial conformity with
tibial channel 16 of tibia 13. In one example, a closed-loop suture
30 is inserted into bone block 24 and captured within graft
fixation member 100. Closed-loop suture 30 could be, but is not
limited to, a Smith & Nephew continuous loop made from
polyester, a strand of suture tied in a loop, or a piece of
polyester closure tape (e.g., Merselene.TM. from Ethicon Inc.,
Cincinnati, Ohio) tied in a loop. As will be described below, graft
fixation member 100 is configured to facilitate positioning and
securing the tissue graft 20.
[0037] Sutures 42 and 44 extend through fixation member 100 and are
removably attached to passing pin 32 which is used to draw the
sutures 42, 44 through the tibial channel 16, femoral channel 14,
and passing channel 18. As described below, sutures 42, 44 are used
to pull graft fixation member 100 through passing channel 18 and
position tissue graft 20 within femoral channel 14 and tibial
channel 16.
[0038] In one example, shown in FIG. 2, in one example graft
fixation member 100 has an elongated body 102 formed of a
biocompatible material (e.g., titanium or acetal) or a
bioabsorbable material (e.g., polylactic acid, polyglycolic acid)
with a length of about 0.45 inches, a width of about 0.16 inches,
and a thickness of about 0.1 inches. Body 102 has a width allowing
fixation member 100 to be pulled through tibial channel 16, femoral
channel 14, and passing channel 18.
[0039] Body 102 includes an intermediate portion 104 having a
length (L), which defines the distance between a pair of channels
108A, 108Bat opposing ends of body 102, described below. In one
example, length (L) of intermediate portion 104 is about 0.05
inches. Intermediate portion 104 supports closed-loop suture 30
during implantation and bears the tension of closed-loop suture 30
after tissue graft 20 has been implanted.
[0040] Pairs of arms 106A and 106B extend from intermediate portion
104. Arms 106 have rounded edges 105 along their length and rounded
ends 107. In one example, rounded edges 105 have a radius of about
0.015 inches and rounded ends 107 have a radius of about 0.067
inches. Rounded edges 105 allow fixation member 100 to be more
easily pulled through tibial channel 16, femoral channel 14, and
passing channel 18.
[0041] Channels 108A and 108B are formed by pairs of arms 106A and
106B, respectively. Channels 108A and 108B are open at end portions
110A and 110B of elongated body 102 and have cylindrical closed
portions 112A and 112B formed by intermediate portion 104 and pairs
of arms 106A and 106B, respectively. For example, cylindrical
closed portions 112A and 112B could have a diameter of about 0.05
inches and channels 108 and 108B could have a corresponding width
of about 0.05 inches. Open end portions 110A and 110B of channels
108A and 108B allow closed-loop suture 30 to pass into channels
108A and 108B as described below.
[0042] In this particular embodiment, each arm 106 has an opening
118 located toward the end of and extending through arm 106.
Openings 118 are cylindrical and have a diameter of about 0.04
inches. Openings 118 in pair of arms 106A are disposed on a common
axis 119A, which is transverse to the length of elongated member
102. Openings 118 in pair of arms 106B are disposed on a common
axis 119B, which is also transverse to the length of elongated
member 102. In other examples, openings 118 could be skewed in
relation to each other or disposed at different positions along
arms 106.
[0043] Referring to FIGS. 3-7, an example of a procedure for
attaching graft fixation member 100 to tissue graft 20 follows.
Referring to FIGS. 3 and 4, opening 28 is formed, for example, by
drilling through bone block 22. A surgeon chooses a closed-loop
suture 30 from closed loops of several lengths to best position the
tissue graft 20 within femoral channel 14 and tibial channel 16
(FIG. 1). The surgeon inserts suture grabber 52 into opening 28
until the end 54 of device 52 extends from bone block 22 and
positions closed-loop suture 30 next to bone block 22. The surgeon
grabs closed-loop suture 30 with suture grabber 52 and pulls both
back through opening 28 in direction 62, forming a first bight 32
and a second bight 34 of about the same size on either side of bone
block 22. Alternatively, a length of suture (not shown) could be
used to pull closed-loop suture 30 into opening 28. One end of the
suture could be passed through opening 28, through closed-loop
suture 30, and back through opening 28. Closed-loop 30 may then be
positioned in opening 28 by pulling both ends of the strand of
suture.
[0044] Referring to FIGS. 5 and 6, bight 32 is positioned around
graft fixation member 100 and into channels 108 so that the
continuous loop of suture 30 is wrapped around intermediate portion
104 of graft fixation member 100. Bight 34 of continuous loop of
suture 30 is then similarly positioned around graft fixation member
100 and into channels 108 so that the continuous loop of suture 30
wraps around intermediate member 104 of graft fixation member 100.
Both bights 32, 34 are wrapped around intermediate member 104 so
that the closed-loop suture 30 does not interfere with the
positioning of strands of suture 42 into openings 118.
[0045] Lengths of suture 42 and 44, shown in FIG. 6, are chosen to
capture closed-loop suture 30 within graft fixation member 100
during the ACL reconstruction described below. In one example,
lengths of polyester closure tape could be used instead of sutures
42, 44. End 43 0f suture 42 is passed through opening 118 (FIG. 2)
in either arm 106 of pair of arms 106A and over closed-loop suture
30. End 43 is then passed through opening 118 in the corresponding
arm 106 of pair of arms 106A thereby capturing closed-loop suture
30 within graft fixation member 100. It is important that suture 42
passes over, and not under, closed-loop suture 30. Allowing suture
42 to pass under closed-loop 30 would not capture closed-loop 30
within graft fixation member 100. Similarly, end 45 of suture 44 is
passed through opening 118 in either arm 106 of a pair of arms 106B
and over closed-loop suture 30. End 45 is then passed through
opening 118 in the corresponding arm 106 of pair of arms 106B
thereby further capturing closed-loop suture 30 within graft
fixation member 100. It is important that suture 44 passes over and
not under closed-loop suture 30. As was the case with suture 42,
passing suture 44 under closed-loop 30 does not capture closed-loop
30 within graft fixation member 100. In this manner, closed-loop
suture 30 is captured twice within fixation member 100.
[0046] Referring to FIG. 7, pulling to sutures 42 and 44 removes
slack from closed-loop suture 30 and positions graft fixation
member 100 to pass through tibial channel 16, femoral channel 14,
and passing channel 18 (FIG. 2).
[0047] An example of a procedure for placing graft fixation member
100 in the position shown in FIG. 8 follows with reference to FIG.
1. Drilling procedures are performed to provide the appropriately
sized tibial channel 16 extending through tibia 13 and femoral
passage 14 in the manner described in the '301 patent. Sutures 42
and 44 are removably attached to passing pin 50. Passing pin 50
(FIG. 1) is then inserted through an incision below the knee and
advanced through tibial channel 16, femoral channel 14, passing
channel 18, the quadriceps tissue, and skin 11 of the thigh. Ends
of sutures 42 and 44 are withdrawn beyond the skin 11 using passing
pin 50.
[0048] The surgeon then pulls graft fixation member 100 by pulling
suture 42 through tibial channel 16, femoral channel 14, and
passing channel 18 to position graft fixation member 100. It is
important that the surgeon keep closed-loop suture 30 captured
within channel 108B by taking up any slack in suture 44 while
advancing graft fixation member 100 through passing channel 18 with
suture 42. However, the surgeon must be careful not to apply too
much tension 30 on suture 44 in relation to the tension on suture
42 or graft fixation member 100 will wedge within tibial channel
16, femoral channel 14, or passing channel 18. Once fixation member
100 has been pulled through passing channel 18, the surgeon
positions fixation member 100 transversely to passing channel 18
and across opening 19. Fixation member 100 is secured against femur
12 by attaching tissue graft 20 to tibia 13 and tensioning tissue
graft 20 and closed-loop suture 30 according to methods described
in the '301 patent.
[0049] Other embodiments are within the scope of the claims.
[0050] For example, referring to FIG. 9, cylindrical portions 112A
and 112B of graft fixation member 100 may have a diameter that is
larger than the width of channels 108A and 108B, respectively. In
one example, portions 112A, 112B have a diameter of about 0.078
inches and channels 108A, 108B have a width of about 0.05 inches.
As the diameter of portions 112A and 112B increases, graft fixation
member 100 can accommodate a thicker closed-loop suture (i.e.,
having an increased number of windings). The width of channels 108A
and 108B do not constrain the sue of thicker closed-loop sutures
because a closed-loop suture may be flattened to pass through
channels 108A and 108B.
[0051] Referring to FIGS. 10 and 11, intermediate portion 152 of
fixation member 150 has a length (L) and defines openings 154, 156
extending through intermediate portion 152. In the example shown in
FIG. 10, intermediate portion has a length of about 0.268 inches
and openings 152, 154 are about 0.078 inches in diameter. In the
example shown in FIG. 11, intermediate portion has a length of
about 0.232 inches and openings 152, 154 are about 0.06 inches in
diameter. A closed-loop suture 30 may be attached to fixation
member 150 using the method described in the '079 application.
Alternatively a first and second end of a length of suture or
closure tape may be threaded through openings 154, 156,
respectively, and tied together. Increasing length L adds material
to intermediate portion 152 and increases the strength of graft
fixation member 150.
[0052] Referring to FIG. 12, fixation member 200 has only one pair
of arms 206 extending from intermediate portion 204 and forming a
single channel 208 at end 210. Arms 206 include cylindrical
openings for capturing closed-loop suture 30 and positioning
fixation member 200. End 212 is closed and rounded to facilitate
passing fixation member 200 through bone passages during the
positioning and attachment of tissue graft 20. End 212 may include
opening 222 through which a strand of suture may be threaded to
improve a surgeon's ability to position fixation member 200 during
an ACL reconstruction procedure.
[0053] Closed-loop suture 30 is captured in fixation member 200 by
positioning arms 206 through bights 32, 34 and threading suture 42
(not shown) through a first opening 218, over bights 32, 34, and
through the second opening 218. In one example, bight 32 is
positioned on a first arm 206 and bight 34 is positioned on a
second arm 206. In another example, bights 32, 34 could be
positioned on the same arm.
[0054] Referring to FIG. 13., fixation member 300 includes openings
304, 308 in intermediate portion 302 and a pair of arms 306 with an
opening 318 through each arm. Closed-loop suture 30 is formed in
openings 304, 308 according to the method described in the '079
application. Alternatively, a piece of suture or closure tape could
be tied into a loop passing through openings 304, 308 as described
above. After forming bight 32 by passing closed-loop suture 30 into
opening 28 in bone block 22, closed-loop suture 30 is captured by
fixation member 300 by positioning either arm 306 through bight 32
and threading a strand of suture (not shown) through openings 318,
as described above.
[0055] Referring to FIG. 14 fixation member 400 is similar in size
to fixation member 100, described above, and has a four opening
configuration described in the '301 and '894 patents. Closed-loop
suture 30 has been formed in openings 404, 408 of fixation member
400 according to the method set forth in the '079 patent, thereby
capturing a first portion of closed-loop suture 30.
[0056] Tissue graft 20 is attached to fixation member 400 by
passing closed-loop suture 30 into opening 28, thereby forming
bight 32, and capturing a second portion of closed-loop suture 30
with fixation member 400. In the example of FIG. 14, bight 32 is
inserted into opening 404 at bottom side 412 of member 400 and out
of opening 404 at top side 412 until bight 32 can extend past end
414 of fixation member 400. End 414 is passed through bight 32.
Bight 32 is pulled in direction 57 until bight 32 tightens around
fixation member 400, thereby capturing a second portion of
closed-loop suture 30. In another example, end 416 could be passed
through bight 32 instead of end 414.
[0057] Referring to FIGS. 15-17, another method by which tissue
graft 20 could be attached to fixation member 400 follows.
Closed-loop suture 30 has been formed around intermediate portion
402 of fixation member 400 according to the method described in the
'079 application and a portion of closed-loop suture 30 is passed
into opening 28, as described above, to form bights 32, 34. Bight
32 is passed through bight 34 on top side 412 of fixation member
400 about 1 inch of closed-loop suture 30 has been pulled through
bight 34. Bight 32 is then opened to form bights 36, 38 and end 414
is then passed through bight 36 and bight 38 is passed through end
416. Closed-loop suture 30 is tensioned in direction 57, removing
slack from closed-loop suture 30 and attaching it to fixation
member 400.
[0058] Referring to FIGS. 18A-D, tissue graft 20 could be attached
to fixation member 400 by capturing closed-loop suture 30 only once
at fixation member 400. For example, closed-loop 30 is passed
through opening 28 (not shown) in bone block 22 to form bight 32
(FIG. 18A). Fixation member 400 is then passed through bight 32
(FIG. 18B) and pulled in direction 66, away from tissue graft 20,
thereby causing bight 32 to tighten around bone block 22, as best
seen in FIG. 18C. In another embodiment, opening 28 is formed along
the length of block 22 (FIG. 18D) instead of transversely, as shown
in examples above. Fixation member 400 is attached to tissue graft
20 in the same manner as described above despite the longitudinal
orientation of opening 28.
[0059] Referring to FIG. 19, closed-loop suture 70 is a suture 72
having opposing ends 73 and 74. In one example, suture 72 could
have a total length of about 1.5 inches. End 73 includes a loop 75
and end 44 includes a loop 46. Loops 45, 46 have a length of about
0.3 inches or less.
[0060] Referring to FIG. 20, a closed-loop suture 30 is formed in
more than one fixation member 400. In one example, closed-loop
suture 30 is formed in fixation member 400A and 400B. When
closed-loop suture 30 is formed by the method disclosed in the '079
application, opening 28 (not shown) in bone block 22 is sized to
permit fixation member 400 to pass through opening 28. When
closed-loop suture 30 is formed by tying a length of suture or
closure tape, opening 28 need only be sized to accommodate the
suture or tape. During implantation, a surgeon could use sutures
(e.g., suture 42, 44) to pass fixation members 400A, 400B through
passing channel 18 at the same time or pass them individually.
[0061] Other embodiments include an alternative approach for
securing a tissue graft within a bone passage using fixation member
100. Specifically, the fixation member 100 and tissue graft 20
could be pulled first through a femoral channel and then through a
tibial channel.
[0062] Although the tissue graft described above has at least one
bone block, other types of grafts may be attached to graft fixation
member including ligament augmentation devices (LAD) formed of
artificial ligament material to which the tissue is sutured.
[0063] In general, graft fixation member 100 van be used to secure
any suitable kinds of grafts, such as alografts, autografts, and
xenografts and can be used in surgical soft tissue reconstruction
procedures other than those related to ACL reconstruction.
[0064] Accordingly, other embodiments are within the scope of the
following claims.
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