U.S. patent application number 12/123334 was filed with the patent office on 2008-11-20 for endobutton continuous loop for bone tendon with double loop knot.
This patent application is currently assigned to Smith & Nephew, Inc.. Invention is credited to Stuart E. Fromm.
Application Number | 20080287991 12/123334 |
Document ID | / |
Family ID | 25330022 |
Filed Date | 2008-11-20 |
United States Patent
Application |
20080287991 |
Kind Code |
A1 |
Fromm; Stuart E. |
November 20, 2008 |
ENDOBUTTON CONTINUOUS LOOP FOR BONE TENDON WITH DOUBLE LOOP
KNOT
Abstract
A method of securing a tissue graft within a bone passage
includes providing a graft fixation member comprising a closed
double-loop having a pair of differently sized loop sections and
capturing both sections of the closed-loop within the fixation
member. The longer loop section is passed through an opening in the
tissue graft then is passed through the smaller loop and thrown
Inventors: |
Fromm; Stuart E.; (Rapid
City, SD) |
Correspondence
Address: |
WILMERHALE/DC
1875 PENNSYLVANIA AVE., NW
WASHINGTON
DC
20004
US
|
Assignee: |
Smith & Nephew, Inc.
Memphis
TN
|
Family ID: |
25330022 |
Appl. No.: |
12/123334 |
Filed: |
May 19, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10895266 |
Jul 20, 2004 |
|
|
|
12123334 |
|
|
|
|
09859096 |
May 16, 2001 |
6533802 |
|
|
10895266 |
|
|
|
|
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 17/0401 20130101;
A61F 2/0811 20130101; A61F 2002/0852 20130101; A61B 2017/0404
20130101; A61F 2002/087 20130101; A61F 2002/0882 20130101; A61B
2017/0459 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1-13. (canceled)
14. A suture loop/button construct, comprising: at least one suture
loop; and a button attached to the at least one suture loop.
15. The suture loop/button construct of claim 14, wherein the
button comprises at least one opening configured to allow the
suture loop to pass through it.
16. The suture loop/button construct of claim 14, wherein the
suture loop is a continuous suture loop.
17. The suture loop/button construct of claim 14, wherein the
button has an oblong configuration.
18. The suture loop/button construct of claim 14, wherein the
button has a length of about 10 to about 20 mm.
19. The suture loop/button construct of claim 14, wherein the
button is formed of material selected from the group consisting of
titanium, titanium alloy, and PLLA.
20. A continuous suture loop/button assembly, comprising: a button
comprising a body and two eyelets extending through opposing
surfaces of the body; a continuous suture loop attached to the two
eyelets; and a suture strand attached to one of the two
eyelets.
21. A method of positioning tissue within the body, comprising the
steps of: providing a suture loop/button construct having a button
with at least one eyelet and a continuous suture loop attached to
the at least one eyelet; providing the suture loop/button construct
in the vicinity of tissue to be positioned; and attaching the
tissue to be positioned to the suture loop/button construct.
22. The method of claim 21 further comprising the steps of: pulling
the suture loop/button construct with the attached tissue through a
socket or a tunnel in a bone; positioning the attached tissue
within the socket or the tunnel in the bone; and securing the
button on a surface of the bone.
23. The method of claim 21, wherein the tissue to be positioned is
biological or non-biological tissue.
24. The method of claim 21, wherein the tissue to be positioned is
selected from the group consisting of ligament, tendon, bone and
cartilage.
25. The method of claim 21, wherein the tissue to be positioned is
soft tissue graft or BTB graft.
26. A method of conducting arthroscopic surgery, comprising the
steps of: forming a bone tunnel or socket; providing a suture
loop/button construct in the vicinity of the bone tunnel or socket,
the suture loop/button construct comprising a button having at
least one eyelet, and a continuous suture loop attached to the at
least one eyelet; attaching a graft to the suture loop/button
construct; and subsequently securing the graft within the bone
tunnel or socket.
27. The method of claim 26 further comprising the steps of
inserting the graft attached to the suture loop/button construct
into the bone tunnel or socket, and passing the suture loop/button
construct through the bone tunnel or socket.
28. The method of claim 27 further comprising the step of securing
the button to a bone cortex abutting the bone tunnel or socket.
29. The method of claim 26, wherein the graft is soft tissue graft
or BTB graft.
30. The method of claim 29, wherein the graft is selected from the
group consisting of an allograft, autograft, and xenograft.
31. The method of claim 26, wherein the bone tunnel or socket is a
femoral or tibial bone tunnel or socket.
32. The method of claim 26, wherein the button has an oblong
configuration.
33. The method of claim 26, wherein the button has a length of
about 10 to about 20 mm.
34. A method of ligament reconstruction, comprising the steps of:
forming a first socket in a first bone by conducting a first action
using a rotary drill cutter, the first bone articulating in a
predetermined manner with a second bone; forming a second socket in
the second bone by conducting a second action using the rotary
drill cutter; providing a suture loop/button construct in the
vicinity of the first and second sockets, the suture loop/button
construct comprising a button with at least one eyelet and a
continuous suture loop attached to the at least one eyelet;
attaching a graft to the suture loop of the suture loop/button
construct; pulling the suture loop/button construct with the
attached graft through the first socket; securing the button of the
suture loop/button construct to a bone cortex abutting the first
socket; and securing the graft within the second socket.
35. The method of claim 34, wherein the first bone is tibia and the
second bone is femur.
36. The method of claim 34, wherein the first bone is femur and the
second bone is tibia.
37. A device for securing a tissue graft within a passage within a
bone comprising: a member comprising an intermediate portion; said
intermediate portion comprising at least two holes; a continuous
suture loop threaded through said holes; said loop being of
sufficient length to attach a graft to said member.
38. A method of preparing a bone-tendon-bone ACL ligament
comprising: providing a fixation button having at least two
openings and further having a length of about 11.43 mm; providing a
continuous suture loop; forming an opening in a bone block;
inserting the continuous suture loop through the opening in the
bone block to form a bight; threading the fixation button through
the bight to attach the graft to the continuous loop.
39. The method of claim 38 further comprising the steps of
inserting the graft attached to the fixation button into a bone
tunnel or socket, and passing the fixation button and continuous
suture loop through the bone tunnel or socket.
40. The method of claim 38 further comprising the step of securing
the button to bone abutting the bone tunnel or socket.
41. The method of claim 38, wherein the bone tunnel or socket is a
femoral bone tunnel or socket.
42. The method of claim 38, wherein the continuous suture loop is
formed from at least one strand of suture.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a Continuation of application Ser. No.
10/895,266 filed on Jul. 20, 2004. Ser. No. 10/895,266 is a
Continuation-in-part of application Ser. No. 09/859,096 filed on
May 16, 2001.
BACKGROUND OF THE INVENTION
[0002] This patent application is a divisional and claims the
benefit of the priority of U.S. patent application Ser. No.
10/895,266, which is a continuation-in-part and claims the benefit
of the priority of U.S. patent application Ser. No. 09/859,096,
filed May 16, 2001, which is now U.S. Pat. No. 6,533,802, published
Mar. 18, 2003, all of which are hereby incorporated by
reference.
[0003] 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, known herein as "the '520
patent") and incorporated by reference.
[0004] A substitute graft harvested from the patient or from a
donor usually replaces an ACL that has ruptured and is
non-repairable. 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,
known herein as "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.
[0005] 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). The graft is then 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.
[0006] Another approach for affixing a tissue graft is described in
U.S. Pat. No. 5,306,301 (issued Apr. 26, 1994, known herein as "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.
[0007] 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.
[0008] 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.
[0009] Still another approach for affixing a tissue graft is
described in U.S. Pat. No. 5,769,894 (issued Jun. 23, 1998, known
herein as "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.
[0010] An alternative to tying a suture to a fixation button is
disclosed in PCT Application WO 99/47079 (published Sep. 23, 1999,
known herein as "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 OF THE INVENTION
[0011] In one aspect of the invention, a method for securing a
tissue graft within a bone passage includes providing a graft
fixation member comprising a closed double-loop having a pair of
loop sections. The first one of the pair of loop sections is passed
through an opening in the tissue graft and is secured to the
fixation member through a knotting technique with the second one of
the pair of loop sections and the graft fixation member. The
knotting technique is achieved by passing the first of the pair
through the second of the pair and positioned over the fixation
member. The fixation member is pulled from the bone block to form
the knot.
[0012] 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 is passed 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.
[0013] 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 defines a cylindrical portion of the
channel having a diameter equal to the width of the channel. Each
pair of arms defines 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 biocompatible material. The
member comprises titanium. The member comprises a bioabsorbable
material.
[0014] Embodiments may have one or more of the following
advantages. The closed double-loop evenly distributes the load when
the loop is passed through a graft. The closed double-loop may be
manufactured and purchased separate from the fixation member. This
allows the surgeon the flexibility to choose the correctly sized
closed double-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 double-loop
without the added cost of multiple fixation members. The closed
double-loop is positively captured within the fixation member
during implantation. The closed double-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 double-loop
may be pre-stressed during the manufacturing process to reduce its
elasticity and increase its strength without accommodation for a
fixation member.
[0015] 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.
BRIEF DESCRIPTION OF DRAWINGS
[0016] FIG. 1 shows an example of a tissue graft being implanted
during an ACL reconstruction procedure using the closed-loop suture
and a graft fixation member.
[0017] FIG. 2 is an example of the graft fixation member.
[0018] FIG. 3 shows an exploded partial view of how a closed-loop
suture could be inserted into tissue graft.
[0019] FIG. 4 is an example of a graft-loop assembly before being
attached to the graft fixation member.
[0020] FIG. 5 shows an exploded partial view of a graft-loop
assembly partially captured by the graft fixation member.
[0021] FIG. 6 shows an exploded partial view of a graft-loop
assembly fully captured by the graft fixation member.
[0022] FIG. 7 shows the graft fixation member positioned for
implantation.
[0023] FIG. 8 shows the tissue graft implanted in a knee and
secured at one end by the graft fixation member.
[0024] FIG. 9 shows an alternative example of a graft fixation
member.
[0025] FIG. 10 shows a second alternative example of a graft
fixation member.
[0026] FIG. 11 shows a third alternative example of a graft
fixation member.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] FIGS. 15-17 show an alternative method for attaching a graft
fixation member to a tissue graft using a closed-loop suture.
[0031] FIGS. 18A-18D show a second alternative method for attaching
a graft fixation member to a tissue graft using a closed-loop
suture.
[0032] FIG. 19 shows an alternative example of a closed-loop
suture.
[0033] FIG. 20 shows a third alternative method for attaching a
graft fixation member to a tissue graft using a closed-loop
suture.
[0034] FIG. 21A is an example of the closed double-loop captured in
the graft fixation member having a pair of closed-loop
sections.
[0035] FIG. 21B shows an exploded partial view of how the longer
end of the closed double-loop suture could be inserted into the
tissue graft.
[0036] FIGS. 21C-21F show a method of tying the knot to secure the
graft fixation member and closed double-loop to the tissue
graft.
[0037] FIG. 21G shows the graft fixation member positioned for
implantation.
[0038] FIG. 22 is an example of the closed double-loop captured in
the graft fixation member having a pair of closed-loop
sections.
[0039] FIG. 23 is a second example of the closed double-loop
captured in the graft fixation member having a pair of closed-loop
sections.
DETAILED DESCRIPTION
[0040] 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. Marselene.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.
[0041] Sutures 42 and 44 extend through fixation member 100 and are
removably attached to passing pin 50 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.
[0042] In one example, shown in FIG. 2, graft fixation member 100
has an elongated body 102 formed of 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.
[0043] Body 102 includes an intermediate portion 104 having a
length (L), which defines the distance between a pair of channels
108A, 108B at opposing ends 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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 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.
[0048] Referring to FIGS. 5 and 6, bight 32 is positioned around
graft fixation member 100 and into channels 108A, 108B so that the
continuous loop of suture 30 is wrapped around intermediate portion
104 of graft fixation member 100. Bight 34 of continuous loop
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.
[0049] 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 of 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 pair of arms 106B
and over closed-loop suture 30. End 45 is then passed through
opening 118 in the capturing 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.
[0050] 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).
[0051] 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.
[0052] 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 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.
[0053] Other embodiments are within the scope of the claims.
[0054] For example, referring to FIG. 9, cylindrical portions 112A
and 112B of graft fixation member 130 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 use of thicker closed-loop sutures
because a closed-loop suture may be flattened to pass through
channels 108A and 108B.
[0055] 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 154, 156 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 154, 156 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.
[0056] 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.
[0057] 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.
[0058] Referring to FIG. 13, fixation member 300 includes openings
304, 308, an 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.
[0059] 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.
[0060] 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 of member 400 and out of
opening 404 at top side 412 until bight 332 can extend past end 414
of fixation member 400. End 414 is passed through bight 32. Bight
32 is pulled in direction 62 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.
[0061] 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; end 414 is
then passed through bight 36, and bight 28 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.
[0062] 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.
[0063] 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 74 includes a loop 76. Loops 75, 76 have a length of about
0.3 inches or less.
[0064] Referring to FIG. 20, a closed-loop suture 230 is formed in
more than one fixation member 400. In one example, closed-loop
suture 230 is formed in fixation member 400A and 400B. When
closed-loop suture 230 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 230 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.
[0065] Tissue graft may also include a closed-double loop formed of
the same suture described above. Referring to FIG. 21A, fixation
member 100 has a four opening configuration as described FIG. 14.
In this embodiment, the closed-loop is a continuous loop 230 passed
twice through openings 104, 108 forming two differently sized loop
ends 32, 34. Loop 230 is captured in fixation member 100. An
advantage of a continuous closed-loop is the even distribution of
the load when the loop is passed through the graft.
[0066] Referring to FIG. 21B, continuous loop 230 is attached to
bone block 22, for example, by drilling an opening 28 through bone
block 22. A surgeon chooses an appropriate closed-loop suture 230
(with fixation member 100) 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 closed-loop suture end 34 is then positioned next to
bone block 22. The surgeon grabs closed-loop suture end 34 with
suture grabber 52 and pulls both through opening 28 in direction
55, leaving loop end 34 on one side of bone block 22. Graft
fixation member 100 and loop end 32 are on the other side of bone
block 22 as shown in FIG. 21C.
[0067] Alternatively, a length of suture (not shown) could be used
instead of a suture grabber to pull closed-loop suture end 34 into
opening 28. One end of the suture could be passed through opening
28, through closed-loop suture 230, and back through opening 28.
Closed-loop 230 may then be positioned in opening 28 by pulling
both ends of the strand of suture.
[0068] In FIG. 21D, loop end 34 is passed under loop end 32 and
pulled above graft fixation member 100. In FIG. 21E, loop end 34 is
opened sufficiently wide to pass over graft fixation member 100. In
FIG. 21F, graft fixation member 100 is pulled tight from bone block
22, causing a knot to form in closed-loop 30, thereby capturing the
bone block 22 with the closed-loop 230 and graft fixation member
100. The small section of the closed-loop dictates where the knot
lies with the knot preferably positioned close to the graft
fixation member.
[0069] Lengths of suture 42 and 44 are passed through respective
holes 116, 112 of fixation member 100. Sutures 42, 44 are used to
position 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 of suture 42 is
passed through opening 116. End 45 of suture 44 is passed though
opening 112.
[0070] Referring to FIG. 21G, pulling sutures 42 and 44 removes
slack from closed-loop suture 30 and places graft fixation member
100 and loop 230 in a position for passing through tibial channel
16, femoral channel 14, and passing channel 18 (FIG. 1).
[0071] As discussed above in conjunction with FIG. 8, 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.
[0072] 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.
[0073] Alternative embodiments of the invention include those shown
in FIGS. 22 and 23. In FIG. 22, loop end 72 of closed-loop 230 is
passed through opening 104, then passed though opening 108. The
loop is not captured, but is held to fixation member 100. In FIG.
23, two differently sized closed-loops 230, 70 are formed in
openings 104, 108 of fixation member 100 according to the method
set forth in the '079 patent. Both closed-loops are captured in
fixation member 100. Loop ends 34, 72 are used in the method of
fixation through knotting in the same manner as loop ends 34, 32
are for the devices described in FIG. 21.
[0074] 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.
[0075] 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.
[0076] In general, the knot tying method using graft fixation
member 100 in combination with closed double-loop 30 can be used to
secure any suitable kinds of grafts, such as allografts,
autografts, and xenografts, and can be used in surgical soft tissue
reconstruction procedures other than those related to ACL
reconstruction.
[0077] Accordingly, other embodiments are within the scope of the
following claims.
* * * * *