U.S. patent application number 14/689338 was filed with the patent office on 2015-11-12 for apparatus and method for tibial fixation of soft tissue.
The applicant listed for this patent is Biomet Sports Medicine, LLC. Invention is credited to James BOUCHER, Stephen M. Howell, James Marcinek, Troy M. Walters.
Application Number | 20150320545 14/689338 |
Document ID | / |
Family ID | 23403688 |
Filed Date | 2015-11-12 |
United States Patent
Application |
20150320545 |
Kind Code |
A1 |
BOUCHER; James ; et
al. |
November 12, 2015 |
Apparatus And Method For Tibial Fixation Of Soft Tissue
Abstract
Methods for fixation of a soft tissue graft in a bone including:
forming in the bone a tunnel defining an entrance opening and an
exit opening at opposite ends of the tunnel, the tunnel including
an anterior wall surface and a posterior wall surface opposite to
the anterior wall surface; positioning the soft tissue graft within
the tunnel such that the soft tissue graft extends through both the
entrance opening and the exit opening of the tunnel; inserting a
graft fixation apparatus into the tunnel and driving spikes of the
graft fixation apparatus into the posterior wall surface to mount
the graft fixation apparatus to the posterior wall surface of the
tunnel such that the graft fixation apparatus is anterior to the
posterior wall surface and is not recessed beneath the posterior
wall surface; and securing the soft tissue graft inside the tunnel
with the graft fixation apparatus.
Inventors: |
BOUCHER; James; (Warsaw,
IN) ; Howell; Stephen M.; (Elk Grove, CA) ;
Marcinek; James; (Warsaw, IN) ; Walters; Troy M.;
(Plymouth, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biomet Sports Medicine, LLC |
Warsaw |
IN |
US |
|
|
Family ID: |
23403688 |
Appl. No.: |
14/689338 |
Filed: |
April 17, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13242143 |
Sep 23, 2011 |
9011534 |
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14689338 |
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11742009 |
Apr 30, 2007 |
8221498 |
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13242143 |
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10874915 |
Jun 23, 2004 |
7211111 |
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11742009 |
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10167074 |
Jun 10, 2002 |
6755840 |
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10874915 |
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09616544 |
Jul 14, 2000 |
6482232 |
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10167074 |
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09356959 |
Jul 19, 1999 |
6280472 |
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09616544 |
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08900602 |
Jul 23, 1997 |
5931869 |
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09356959 |
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Current U.S.
Class: |
623/13.14 |
Current CPC
Class: |
A61B 17/8872 20130101;
A61F 2/0805 20130101; A61F 2220/0016 20130101; A61F 2002/0888
20130101; A61B 2090/034 20160201; Y10S 606/916 20130101; A61B
17/1604 20130101; A61B 17/1764 20130101; A61B 17/0642 20130101;
A61B 2017/0641 20130101; A61B 17/1675 20130101; A61F 2002/0858
20130101; A61F 2/0811 20130101; A61F 2002/0829 20130101; A61B
17/1714 20130101; A61F 2002/0882 20130101; A61B 2017/0648
20130101 |
International
Class: |
A61F 2/08 20060101
A61F002/08 |
Claims
1. An apparatus for fixation of a soft tissue within a bore formed
in a bone of an anatomy, comprising: a member defining a first
portion having a first side and a second side and a first end
configured to be positioned further in the bore than a second end;
the first side includes a plurality of first projections configured
to engage the soft tissue against the bore; the second side
includes a cooperation surface configured to cooperate with an
interference member; and a second portion formed as a single piece
with and extending from the second end of the member configured to
prevent the member from axially extending into the bore more than a
predetermined amount; wherein the first end includes a rounded nose
and defines a notch.
2. The apparatus of claim 1, wherein the notch is V-shaped.
3. The apparatus of claim 2, wherein the V-shaped notch includes a
plurality of V-shaped notches substantially parallel with each
other.
4. The apparatus of claim 1, wherein the second portion extends
substantially transversely to a longitudinal axis of the
member.
5. The apparatus of claim 1, wherein the second portion includes a
first wing extending from a first edge of the member and a second
wing extending from a second edge of the member.
6. The apparatus of claim 1, wherein the interference member is a
screw.
7. The apparatus of claim 1, wherein the plurality of first
projections includes a plurality of first projections formed
substantially parallel to one another.
8. The apparatus of claim 1, wherein the member is formed of at
least one of a titanium, stainless steel, titanium alloy,
cobalt-chrome-molybdenum alloy, polymer, or a resorbable
polymer.
9. The apparatus of claim 4, wherein the second portion includes a
bone engaging face that is substantially planar.
10. An apparatus for fixation of a soft tissue within a bore formed
in a bone of an anatomy, comprising: a first member extending
between a first end and a second end, wherein the first member
includes a first side and a second side, wherein the first side is
configured to engage the soft tissue and the second side defines a
first cooperation surface; a first wing extending from the second
end of the first member and configured to engage an exterior of the
bone when the first end of the first member is positioned in the
bore formed in the anatomy; a second member extending between a
second member first end and a second member second end; wherein the
second member includes a second cooperation surface configured to
engage the first cooperation surface; wherein the second member is
configured to be moved relative to the first member; wherein the
first wing cooperates with the bone to eliminate a selected
movement of the first member.
11. The apparatus of claim 10, wherein the first member is
configured to be positioned at a first position in the bore;
wherein the second member is configured to engage the first member
and be positioned at a second position in the bore; wherein the
first wing is configured to maintain the first member in the first
position in the bore.
12. The apparatus of claim 10, further comprising: a plurality of
projections extending from the first side operable to engage the
soft tissue; and a valley defined between at least two of the
plurality of projections.
13. The apparatus of claim 10, wherein said first end includes a
rounded leading edge defining a V-shaped notch.
14. The apparatus of claim 10, wherein the first wing extends from
the first member away from the first cooperation surface to allow
the second member to engage the first cooperation surface.
15. The apparatus of claim 10, wherein the first member further
comprises: a longitudinal edge extending from the first end to the
second end; and a depression in the longitudinal edge.
16. The apparatus of claim 10, further comprising: a driver
configured to drive the second member relative to the first member
in the anatomy.
17. The apparatus of claim 10, further comprising: at least one
notch defined at the first end of the first member.
18. The apparatus of claim 17, wherein the at least one notch
includes three notches that extend longitudinally of the first
member and are substantially parallel to one another.
19. The apparatus of claim 10, wherein the second member is a
screw.
20. An apparatus for fixation of a soft tissue within a bore formed
in a bone of an anatomy, comprising: a first member extending
between a first end and a second end and having a first side and a
second side; the first side includes a plurality of first
projections configured to engage the soft tissue against the bore,
the second sides includes a cooperation surface configured to
cooperate with a second member, a first wing extending from the
second end of the first member and configured to engage an exterior
of the bone when the first end of the first member is positioned in
the bore formed in the anatomy; and the second member extending
between a second member first end and a second member second end;
wherein the second member includes a second cooperation surface
configured to engage the first cooperation surface; wherein the
second member is configured to be moved relative to the first
member; wherein the first wing cooperates with the bone to
eliminate a selected movement of the first member; wherein the
first end of the first member includes a rounded nose.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 13/242,143 filed on Sep. 23, 2011, which is a continuation
of U.S. patent application Ser. No. 11/742,009, filed Apr. 30,
2007, now U.S. Pat. No. 8,221,498 issued on Jul. 17, 2012; which is
a divisional of U.S. patent application Ser. No. 10/874,915 filed
Jun. 23, 2004, now U.S. Pat. No. 7,211,111 issued May 1, 2007;
which is a divisional of U.S. patent application Ser. No.
10/167,074 filed Jun. 10, 2002, now U.S. Pat. No. 6,755,840 issued
Jun. 29, 2004; which is a divisional of U.S. patent application
Ser. No. 09/616,544 filed on Jul. 14, 2000, now U.S. Pat. No.
6,482,232 issued Nov. 19, 2002; which is a continuation of U.S.
patent application Ser. No. 09/356,959 filed Jul. 19, 1999, now
U.S. Pat. No. 6,280,472, issued Aug. 28, 2001; which is a
continuation-in-part of U.S. patent application Ser. No. 08/900,602
filed Jul. 23, 1997, now U.S. Pat. No. 5,931,869 issued Aug. 3,
1999. The disclosures of the above applications are incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates generally to an apparatus and method
for use in orthopedic surgery and, more particularly, to an
apparatus and method for tibial fixation of a soft tissue graft
through a tibial bore.
BACKGROUND OF THE INVENTION
[0003] Ligaments are strong fibrous connective soft tissue which
connect the articular ends of bones to bind them together and to
facilitate or limit motion. Injuries to ligaments are common, and
patients who are physically active are generally more susceptible
to such ligament injuries. The anterior cruciate ligament (ACL) of
the knee joint is a ligament frequently injured by such patients.
Such injuries cause instability in the knee joint which, when left
untreated, may lead to degenerative arthritis. Because of this
condition, ACL reconstruction may be required. Generally during ACL
reconstruction, a substitute soft tissue ligament or graft is
attached to the femur and/or tibia to facilitate regrowth and
permanent attachment.
[0004] One method of performing this reconstruction involves the
use of a section of bone-patellar tendon-bone as a graft. With this
method, a ligament tunnel is bored into both the femur and the
tibia and the bone-patellar tendon-bone graft is centered between
the tunnel. The bone portions of the graft are then each secured
within the respective tunnel by tightening an interference screw in
each tunnel between the bone graft and the side of the tunnel.
[0005] However, use of such a technique presents several
disadvantages. For example, the graft may be inadvertently cut or
frayed by the sharp edges of the interference screw during
insertion of the screw and subsequent to fixation. Moreover, if the
interference screw or the bone graft is slightly oversized versus
the size of the tunnel, the interference screw may cause too much
force to be exerted on the bone graft portion as the interference
screw is tightened. This may subsequently cause the bone graft
portion to be damaged and not usable. In addition, it is often
difficult to accurately gauge the length of the bone-patellar
tendon-bone graft in relation to the ligament tunnels such that the
bone graft portions may not seat appropriately within the tunnels
or be properly tensioned.
[0006] Another method for performing this reconstruction involves
the use of only a soft tissue ligament graft. Such a graft is
generally taken from the hamstring ligament, specifically, the
semitendinosus and gracilis ligaments or tendons. Such grafts are
generally fed through the ligament tunnel and secured outside the
tunnel. The graft is generally secured by a non-endoscopic means of
stapling or screwing the graft onto the outside surface of the
tibia and/or femur.
[0007] However, this method of securing the soft tissue graft also
exhibits disadvantages. For example, since the various staple or
screw and washer assemblies in existence are positioned on the
outside of the bone surface or extend beyond the bone surface, such
components are more easily noticed by the patient and in some
instances may cause patient discomfort. In addition, because of the
discomfort, it may be required to perform subsequent surgery to
remove the staple or screw and washer assembly once the graft has
permanently attached to the bone, thereby subjecting the patient to
a second surgery, as well as increasing overall surgical costs. The
staple or screw and washer assembly are also not substantially
resistant to slippage and do not provide stiff securement. In other
words, the graft may permanently slip under the securement of the
staple or screw and washer assembly thereby providing a non-optimum
tension on the graft. Securement at the anchoring point may be
resilient such that if the graft utilizes sutures in combination
with the staple or screw washer assembly, the anchoring point may
stretch under stress and resiliently return, thereby also providing
non-optimum tensioning or stiffness for the graft.
[0008] Another method for securing the soft tissue ligament graft
within a femoral tunnel is set forth in U.S. Pat. No. 5,431,651.
This reference uses a cleated washer which engages the soft tissue
graft within the femoral tunnel by use of a transverse cannulated
set screw. The cleated washer is drawn into the femoral tunnel by
use of a suture coupled to the washer and pulled through the
cannulated set screw. Once in position adjacent to the set screw,
the set screw engages the cleated washer against the soft tissue
ligament and the wall of the tunnel.
[0009] However, this method of securing a soft tissue graft within
a femoral tunnel also exhibits many disadvantages. For example,
such a procedure will generally require more surgical time since it
includes the added steps of passing a suture through a cannulated
set screw and down the femoral tunnel, as well as attaching it to
the cleated washer itself. This also makes it extremely difficult
to properly align the cleated washer since the cleated washer must
be pulled through and aligned using a flexible non-rigid suture.
Additionally, it may be difficult to maintain the location of the
cleated washer as the set screw is engaged against the washer since
the suture does not rigidly hold or maintain the position of the
cleated washer. Finally, by drawing the cleated washer up through
the femoral tunnel, a larger femoral tunnel may be required and the
spikes on the cleated washer may cut or fray the soft tissue graft
as it is passed through the femoral tunnel.
[0010] What is needed then is an apparatus and method for tibial
fixation of a soft tissue graft which does not suffer from the
above-identified disadvantages. This in turn, will reduce the
possibility for damaging the soft tissue graft; reduce the
possibility for requiring a new graft from being harvested; provide
for endoscopic securement of a soft tissue graft without damaging
the graft; reduce or eliminate potential patient discomfort;
provide endoscopic fixation which is flush to the bone surface;
reduce or eliminate the need for a subsequent surgery to remove
fixation components after the graft has been permanently attached
to the bone; provide increased fixation strength; provide less
pretensioning of the graft to restore knee stability, thereby not
over-constraining the knee after setting the tension on the graft;
reduce or eliminate the potential for slippage of the soft tissue
graft; increase stiffness and mechanical behavior of the soft
tissue graft; reduce the number of steps to secure the soft tissue
graft; and reduce the number of separate instrumentation required
to secure the soft tissue grafts. It is, therefore, an object of
the present invention to provide such an apparatus and method for
tibial fixation of a soft tissue graft.
SUMMARY OF THE INVENTION
[0011] This section provides a general summary of the disclosure,
and is not a comprehensive disclosure of its full scope or all of
its features.
[0012] The present teachings provide for a method for fixation of a
soft tissue graft in a bone. The method includes the following:
forming in the bone a tunnel defining an entrance opening and an
exit opening at opposite ends of the tunnel, the tunnel including
an anterior wall surface and a posterior wall surface opposite to
the anterior wall surface; forming a passage in the bone
perpendicular to the tunnel by removing both an anterior edge of
the bone at the entrance opening and a portion of the anterior wall
surface associated with the anterior edge of the bone; positioning
the soft tissue graft in the tunnel such that the soft tissue graft
extends through both the entrance opening and the exit opening of
the tunnel; inserting a graft fixation apparatus through the
passage and driving spikes of the graft fixation apparatus into the
posterior wall surface to mount the graft fixation apparatus to the
posterior wall surface of the tunnel; and securing the soft tissue
graft inside the tunnel with the graft fixation apparatus.
[0013] The present teachings also provide for a method for fixation
of a soft tissue graft in a bone. The method includes the
following: forming in the bone a tunnel defining an entrance
opening and an exit opening at opposite ends of the tunnel, the
tunnel including an anterior wall surface and a posterior wall
surface opposite to the anterior wall surface; positioning the soft
tissue graft within the tunnel such that the soft tissue graft
extends through both the entrance opening and the exit opening of
the tunnel; inserting a graft fixation apparatus into the tunnel
and driving spikes of the graft fixation apparatus into the
posterior wall surface to mount the graft fixation apparatus to the
posterior wall surface of the tunnel such that the graft fixation
apparatus is anterior to the posterior wall surface and is not
recessed beneath the posterior wall surface; and securing the soft
tissue graft inside the tunnel with the graft fixation
apparatus.
[0014] The present teachings still further provide for a method for
fixation of a soft tissue graft in a bone. The method includes
forming in the bone a tunnel defining an entrance opening and an
exit opening at opposite ends of the tunnel, the tunnel including
an anterior wall surface and a posterior wall surface opposite to
the anterior wall surface; inserting a cutting guide into the
tunnel such that a positioning bar of the cutting guide abuts an
outer surface of the bone at the entrance opening of the tunnel;
mounting a cutting instrument to the guide and positioning a
cutting blade of the cutting instrument on an exterior anterior
surface of the bone; removing an anterior edge of the bone at the
entrance opening by driving the cutting blade through the exterior
anterior surface of the bone and a portion of the anterior wall
surface associated with the anterior edge of the bone; positioning
the soft tissue graft in the tunnel such that the soft tissue graft
extends through both the entrance opening and the exit opening of
the tunnel; impacting spikes of a graft fixation apparatus into a
region of the posterior wall surface opposite to where the portion
of the anterior wall surface has been removed to anchor the graft
fixation apparatus in the tunnel such that a body of the graft
fixation apparatus is anterior to the posterior wall surface and is
not recessed beneath the posterior wall surface; tensioning the
soft tissue graft; and securing the soft tissue graft inside the
tunnel with the graft fixation apparatus.
[0015] Further areas of applicability will become apparent from the
description provided herein. The description and specific examples
in this summary are intended for purposes of illustration only and
are not intended to limit the scope of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Still other advantages of the present invention will become
apparent to those skilled in the art after reading the following
specification by reference to the drawings in which:
[0017] FIG. 1 is a side view of an apparatus for tibial fixation of
a soft tissue graft according to the teachings of the present
invention;
[0018] FIG. 2 is a top view of the tibial fixation apparatus of
FIG. 1;
[0019] FIG. 3 is a side cross-sectional view of the tibial fixation
apparatus of FIG. 1 taken along line 3-3 of FIG. 2;
[0020] FIG. 4 is a top view of a counterbore drill guide used in
preparing a counterbore to nestingly receive the tibial fixation
apparatus of FIG. 1;
[0021] FIGS. 5A-5E illustrates a method for attaching a soft tissue
graft using the tibial fixation apparatus according to the
teachings of the present invention;
[0022] FIG. 6A-6E illustrates another method for attaching a soft
tissue graft using the tibial fixation apparatus according to the
teachings of the present invention;
[0023] FIG. 7 is a top view of another apparatus for tibial
fixation of a soft tissue graft according to the teachings of the
present invention;
[0024] FIG. 8 is a bottom view of the tibial fixation apparatus of
FIG. 7;
[0025] FIG. 9 is a front view of the tibial fixation apparatus of
FIG. 7;
[0026] FIG. 10 is a side cross-sectional view of the tibial
fixation apparatus of FIG. 7 taken along line 10-10 of FIG. 7;
[0027] FIG. 11 is a perspective view illustrating a method for
positioning the tibial fixation apparatus of FIG. 7;
[0028] FIG. 12 is a side cross-sectional view taken along line
12-12 of FIG. 11 illustrating the method for positioning the tibial
fixation apparatus of FIG. 7;
[0029] FIG. 13 is a top-end view of another apparatus for tibial
fixation of a soft tissue graft according to the teachings of the
present invention;
[0030] FIG. 14 is a bottom-end view of a tibial fixation apparatus
of FIG. 13;
[0031] FIG. 15 is a side-end view of the tibial fixation apparatus
of FIG. 13;
[0032] FIG. 16 is a top view of an instrument utilized for grasping
the tibial fixation apparatus of FIG. 13;
[0033] FIG. 17 is a side cross-sectional view illustrating a method
for positioning the tibial fixation apparatus of FIG. 13 employing
the instrument of FIG. 16;
[0034] FIG. 18 is a side cross-sectional view of a tibial fixation
apparatus according to the teachings of the preferred embodiment of
the present invention;
[0035] FIG. 19 is a perspective view of a counterbore guide used in
preparing a counterbore to nestingly receive the tibial fixation
apparatus of FIG. 18;
[0036] FIG. 20 is an elevational view of a first portion of a
multi-purpose instrument;
[0037] FIG. 21 is an elevational view of a second portion of the
multi-purpose instrument of FIG. 20;
[0038] FIGS. 22A-22D illustrates a first preferred method for
attaching a soft tissue graft using the tibial fixation apparatus
according to the teachings of the preferred embodiment of the
present invention;
[0039] FIG. 23 is a perspective view of another counterbore guide
used in preparing a counterbore to nestingly receive the tibial
fixation apparatus of FIG. 18;
[0040] FIG. 24 is an elevational view of another multi-purpose
instrument; and
[0041] FIGS. 25A-25C illustrates a second preferred method for
attaching a soft tissue graft using the tibial fixation apparatus
according to the teachings of the preferred embodiment of the
present invention.
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
[0042] The following description of various embodiments concerning
an apparatus and method for tibial fixation of soft tissue grafts
are merely exemplary in nature and are in no way intended to limit
the invention or its application or uses. Moreover, while the
present invention is described in detail below with reference to
tibial fixation of soft tissue grafts through a tibial tunnel, it
will be appreciated by those skilled in the art that the present
invention is clearly not limited to fixation in a tibial tunnel and
may be utilized to secure soft tissue grafts, tendons, ligaments,
etc. in various other tunnels, bores or adjacent to a bone.
[0043] Referring to FIGS. 1-3, an apparatus 10 for tibial fixation
of a soft tissue graft according to the teachings of one embodiment
of the present invention is shown. The apparatus or washer 10
includes a cylindrical body 12 having a diameter of about 16
millimeters and a plurality of spikes 14. The cylindrical body 12
includes a substantially cylindrical sidewall 16 having beveled or
rounded edges 18 and a substantially flat planar relief face 20
formed into a portion of the cylindrical sidewall 16. The body 12
further defines a concentric internal bore 22 having an internal
sidewall 24 with a diameter of about 0.234 inches which is adapted
to receive a compression bone screw, further discussed herein. A
first side or top 26 of the body 12 includes a concentric
counterbore 28 operable to flushly receive a head of the
compression screw. A second side or bottom 30 of the body 12 is
substantially planar and has the plurality of spikes 14 extending
out from the second side 30.
[0044] The plurality of spikes 14 includes a first plurality or
four cylindrical guide spikes 32 each having a length from the top
26 of the body 12 to the tip 34 of the spikes 32 of about 0.52
inches and a cylindrical diameter of about 0.062 inches. The four
spikes 32 are positioned concentrically about the body 12 at a
radius of about 0.25 inches from the center of the body 12. The
plurality of spikes 14 further includes a second plurality or
thirteen cylindrical engagement spikes 36 each having a length from
the top 26 of the body 12 to the tip 34 of the spikes 36 of about
0.34 inches and a cylindrical diameter of about 0.047 inches. The
cylindrical spikes 32 and 36 each include the pointed end 34
operable to engage and penetrate cancellous and cortical bone. The
engagement spikes 36 are positioned between the guide spikes 32 and
the internal bore 22 in such a manner that the engagement spikes 36
are able to penetrate and secure the soft tissue graft at multiple
sites, further discussed herein.
[0045] The apparatus or washer 10 is preferably made from a
suitable biocompatible material such as titanium, stainless steel,
titanium alloy, cobalt-chrome-molybdenum alloy, polymer, resorbable
polymer, etc. The apparatus 10 preferably consists of an assembly
of separate spikes 14 which are welded to the body 12, via welds
38. Alternatively, the apparatus 10 may be cast or machined to the
required shape and size.
[0046] Referring to FIG. 4, a counterbore drill guide 40 is shown
for use in preparation of a substantially perpendicular counterbore
relative to a tibial tunnel formed in a tibia, further discussed
herein. The counterbore drill guide 40 includes a substantially
cylindrical body 42 defining a planar notched region 44 having a
center aperture 46 for receipt of a counterbore drill bit.
Positioned adjacent to the notched region 44 is a positioning bar
48 passing medially through the body 42. The positioning bar 48 is
slidably engaged with the body 42 and is utilized to engage the
medial cortex of the tibia to provide a predetermined insertion
length of the counterbore drill guide 40 into the tibial tunnel.
Set back from the positioning bar 48 is a T-shaped handle 50 which
can be utilized by the surgeon to hold the counterbore drill guide
40 during counterbore drilling. The body 42 of the counterbore
drill guide 40 is about 7 millimeters in diameter, with the notched
region 44 beginning at about 20 millimeters from a distal end of
the drill guide 40. The notched region 44 is about 17 millimeters
wide having about a 3.5 millimeter diameter centering hole 46. The
positioning bar 48 is set back about 10 millimeters from the center
of the centering hole 46, thereby providing a predetermined
insertion length within the tibial tunnel of about 38.5
millimeters. The counterbore drill guide 40 is preferably made from
stainless steel or other suitable material.
[0047] Turning to FIGS. 5A-5E, one method for tibial fixation of a
soft tissue graft will now be described. Initially, soft tissue
grafts are harvested for use in an anterior cruciate ligament (ACL)
reconstruction. The semitendinosus and gracilis tendons from their
respective hamstring muscles are generally used and harvested from
the patient or by way of donor tendons using techniques well known
in the art. Alternatively, synthetic grafts may also be employed.
The harvested grafts will generally consist of two tubular grafts
which are subsequently looped at their mid-section to form a four
bundle graft. The four bundle graft should be sized to pass without
friction through a tibial and femoral tunnel.
[0048] Once the grafts have been harvested and prepared using known
techniques, tunnel or hole placement is then performed. A tibial
tunnel or bore 52 is drilled through the tibia 54 and into the
femur 56 creating a femoral tunnel 58. The tibial tunnel 52 will
typically have a diameter between about 7 to 13 millimeters,
preferably 8-9 millimeters, and is bored utilizing a drill bit and
a driver. The tibial tunnel 52 exits at about the center of the
tibial plateau and enters the tibia 54 at about 50 millimeters from
the top of the tibial plateau medial to the tibial tubercle or at
the medial cortex. Since the tibial tunnel 52 angles through the
tibia 54, it creates an elliptical entrance opening 60 and an
elliptical exit opening 62. The drill bit utilized to bore the
tibial tunnel 52 also generally bores the femoral tunnel 58 in the
femur 56 by continuing to extend the drill bit through the tibial
tunnel 52 and into the femur 56. The tibial tunnel 52 and the
femoral tunnel 58 are bored using techniques well known in the art
which may include the use of alignment or drill guide mechanisms in
combination with a drill bit and driver.
[0049] Once the tibial tunnel 52 is bored through the tibia 54, the
body 42 of the counterbore drill guide 40 is axially slid into the
entrance opening 60 of the tibial tunnel 52. The counterbore drill
guide 40 is advanced into the tibial tunnel 52 until the
positioning bar 48 is flush against the medial cortex of the tibia
54. This will align the centering hole 46 adjacent to an anterior
edge 64 of the entrance opening 60 of the tibial tunnel 52.
[0050] With the counterbore drill guide 40 properly positioned
within the tibial tunnel 52 and held by the handle 50, a
counterbore 66 is formed substantially perpendicular to the tibial
tunnel 52 using a counterbore bit 68 and a drive mechanism 70. The
counterbore bit 68 includes a centering nose 72 which rotatably
engages the centering hole 46 formed into the counterbore drill
guide 40. The centering nose 72 is formed similar to a drill bit so
that the centering nose 72 drills into the tibia 54. The
counterbore 66 is preferably bored to remove the anterior edge 64
of the entrance opening 60 providing a substantially perpendicular
counterbore 66. In other words, the centering nose 72 is directed
through the tibia 54 and inserted in the centering hole 46 in the
counterbore drill guide 40 such that the counterbore bit 68 is
perpendicular to a posterior wall 74 of the tibial tunnel 52. The
counterbore bit 68 is advanced to remove the anterior tibial cortex
adjacent to an anterior wall 76 until it seats in the notch region
44 in the counterbore drill guide 40. The bone reamings may then be
collected and saved for subsequent grafting of the tibial tunnel
52.
[0051] Once the counterbore 66 has been formed utilizing the
counterbore bit 68, a four bundle graft 78 is first secured within
the femoral tunnel 58 of the femur 56 using one of many techniques
known in the art. Preferably, the four bundle graft 78 is secured
within the femoral tunnel 58 of the femur 56 by means of a bone
mulch screw, set forth in U.S. Pat. No. 5,674,224, "BONE MULCH
SCREW ASSEMBLY FOR ENDOSTEAL FIXATION OF SOFT TISSUE GRAFTS AND
METHOD FOR USING SAME", which is hereby incorporated by reference.
With the graft 78 secured within the femoral tunnel 58, the graft
78 extends out through the tibial tunnel 52.
[0052] The apparatus 10 is then engaged and secured to the tibia 54
by use of an impactor 80 in combination with a mallet. The impactor
80 has a generally cylindrical body 82 which tapers to a striking
end 84. The impactor 80 includes a complimentary face 86 having a
concentric guide post 88 which is received within the internal bore
22 and an arcuate surface 90 which is received within the
counterbore 28. The impactor 80 further includes an edge guide 92
which engages and mates with the planar relief face 20 formed
within the apparatus 10. The edge guide 92 enables the surgeon to
properly rotatably align the apparatus 10 by simply rotating the
impactor 80 within the counterbore 66 and engaging the planar face
20 with the edge guide 92.
[0053] The graft 78 is oriented such that two grafts 94 and 96 of
the four bundle graft 78 pass along a first side of the guide post
88 and two grafts 98 and 100 pass along a second side the guide
post 88 such that each pair of grafts are positioned or guided
between the guide post 88 and the longer guide spikes 32. The
apparatus 10 is initially partially engaged with only the guide
spikes 32 penetrating cancellous and cortical bone of the tibia 54
and the relief face 20 directed toward the entrance opening 60.
With the guide spikes 32 engaging the tibia 54, the four bundle
graft 78 is appropriately tensioned by pulling the four bundle
graft 78 under the engagement spikes 36 within the counterbore 66
and out of an area 102 defined by the relief 20 and the counterbore
66 without binding on the sidewall 16 or the counterbore 66. The
two stage spikes 14 having the first plurality of spikes 32 of a
first length and the second plurality of spikes 36 having a second
shorter length enables the apparatus 10 to be initially secured to
the tibia 54 with only the spikes 32, while allowing proper
tensioning and guiding of the four bundle graft 78.
[0054] The four bundle graft 78 is properly tensioned generally by
means of pulling on the ends of the graft 78 extending out of the
area 102 under the relief 20 manually or with a tensioning device
with the knee in full extension. A preferred tensioning device is
set forth in U.S. Pat. No. 5,507,750 entitled, "METHOD AND
APPARATUS FOR TENSIONING GRAFTS AND LIGAMENTS", which is hereby
incorporated by reference. Once the proper tension is achieved, the
apparatus 10 is fully seated or nested within the counterbore 66 by
use of the impactor 80 and a mallet, as shown clearly in FIG. 5C.
Upon seating the apparatus 10, the engagement spikes 36 penetrate
the two grafts 94 and 96 on the first side of the guide post 88 at
multiple sites and the two grafts 98 and 100 on the second side of
the guide post 88 to maintain proper tensioning of the four bundle
graft 78. The apparatus or washer 10 thus seats or nests flush
within the counterbore 66 thereby eliminating any objects extending
out beyond the tibia 54. The relief 20 is also used to eliminate
any portion of the apparatus 10 from extending out beyond the tibia
54.
[0055] With the apparatus 10 fully nested within the counterbore 66
or posterior wall 74 of the tibia tunnel 52, a drill guide 101 is
inserted into the internal bore 22 of the apparatus 10 to maintain
the separation of the four bundle graft 78. The drill guide 101 is
advanced between the two grafts 94 and 96 on the first side of the
guide post 88 and the two grafts 98 and 100 on the second side of
the guide post 88 so that it is flush against the posterior wall 74
of the tibial tunnel 52. A 3.5 millimeter drill bit 104 attached to
the driver 70 is then utilized to drill a bore 106 through the
tibia 54 to the posterior cortex of the tibia 54. Once the bore 106
is drilled through the tibia 54, the depth of the bore 106 is
measured and the posterior cortex region is tapped using an
appropriate tap.
[0056] With the bore 106 formed and tapped, a low profile
compression screw 108 is inserted into the internal bore 22 and
screwed into the bore 106 in the tibia 54 to threadably secure the
compression screw 108 within the bore 106 and complete the fixation
of the apparatus 10 within the counterbore 66. The compression
screw 108 includes a head 110 which is flushly received within the
counterbore 28, a threaded section 112, and a cylindrical
non-threaded section 114 passing through the body 12 of the
apparatus 10. Once the compression screw 108 has been fully
secured, the ends of the grafts 94-100 may be trimmed back within
the area 102. The apparatus 10 provides a substantially stiff and
slippage free anchoring for the graft 78.
[0057] Turning to FIGS. 6A-6E, another method for tibial fixation
of a soft tissue graft will now be described. In this regard, like
reference numerals will be used to reference to like structures.
Once the grafts have been harvested and prepared using the known
techniques, tunnel or hole placement is again performed. The tibial
tunnel or bore 52 is drilled through the tibia 54 and into the
femur 56 creating a femoral tunnel 58. The tibial tunnel 52 will
typically have a diameter between about 7 to 13 millimeters,
preferably 8-9 millimeters, and is bored utilizing a drill bit and
a driver. The tibial tunnel 52 exits at about the center of the
tibial plateau and enters the tibia 54 at about 50 millimeters from
the top of the tibial plateau medial to the tibial tubercle or at
the medial cortex. Since the tibial tunnel 52 angles through the
tibia 54, it creates an elliptical entrance opening 60 and an
elliptical exit opening 62. The drill bit utilized to bore the
tibial tunnel 52 also generally bores the femoral tunnel 58 in the
femur 56 by continuing to extend the drill bit through the tibial
tunnel 52 and into the femur 56. The tibial tunnel 52 and the
femoral tunnel 58 are bored using techniques well known in the art
which may include the use of alignment or drill guide mechanisms in
combination with a drill bit and driver.
[0058] Once the tibial tunnel 52 is bored through the tibia 54, a
pilot hole 55 is bored straight through the tibia 54 parallel with
the tibia plateau. Specifically, the pilot hole 55 is started at
the intersection point at the bottom of the entrance 60 and is
drilled from the anterior medial to posterior lateral side
utilizing a drill bit 57 driven by the drive mechanism 70. The
pilot hole 55 is preferably about 2 to 3 millimeters in
diameter.
[0059] Once the pilot hole 55 has been formed or bored, a
counterbore 59 is formed at the anterior medial side of the tibia
54 using a counterbore bit 61 and the drive mechanism 70. The
counterbore bit 61 includes a pilot nose 63 which engages the pilot
hole 55 to accurately align the counterbore bit 61 concentric with
the pilot hole 55 and relative to the entrance opening 60. The
counterbore 59 is preferably bored to a depth of about 6 to 7
millimeters which intersects with the tibial tunnel 52 or entrance
opening 60.
[0060] Once the counterbore 59 has been formed utilizing the
counterbore bit 61, the four bundle graft 78 is first secured
within the femoral tunnel 58 of the femur 56 using one of the many
techniques known in the art. Here again, the four bundle graft 78
is preferably secured within the femoral tunnel 58 of the femur 56
by means of the bone mulch screw, set forth in U.S. Pat. No.
5,674,224 "BONE MULCH SCREW ASSEMBLY FOR ENDOSTEAL FIXATION OF SOFT
TISSUE GRAFTS AND METHOD FOR USING SAME", which is hereby
incorporated by reference. With the graft 78 secured within the
femoral tunnel 58, the graft 78 extends out through the tibial
tunnel 52.
[0061] The apparatus 10 is then engaged to the tibia 54 by means of
a bone screw 65 having a head 67 and the spikes 32. The graft 78 is
oriented such that the two grafts 94 and 96 of the four bundle
graft 78 pass along a first side of the bone screw 65 and two
grafts 98 and 100 pass along a second side the bone screw 65 such
that the pair of grafts are positioned or guided between the bone
screw 65 and the longer guide spikes 32. The apparatus 10 is
initially partially engaged with only the guide spikes 32
penetrating cancellous and cortical bone of the tibia 54 and the
bone screw 65 partially set.
[0062] With the guide spikes 32 engaging the tibia 54, the four
bundle graft 78 is appropriately tensioned by pulling the four
bundle graft 78 under the engagement spikes 32 along the
counterbore 59 and out of an area 69 defined by the relief 20 and
the counterbore 59 without binding on the sidewall 16 or the
counterbore 59. The two stage spikes 14 having the first plurality
of spikes 32 of a first length and the second plurality of spikes
36 having a second shorter length enables the apparatus 10 to be
initially secured to the tibia 54 with only the spike 32 and bone
screw 65, while allowing tensioning and guiding of the four bundle
graft 78.
[0063] With the four bundle graft 78 properly tensioned, generally
by means of pulling on the ends of the graft 78 extending out of
the area 69 under the relief 20, the bone screw 65 is further
turned to fully seat the apparatus or washer 10 flush within the
counterbore 59, as shown clearly in FIG. 6D. Upon turning the bone
screw 65, the engagement spikes 36 penetrate the two grafts 94 and
96 on the first side of the bone screw 65 and the two grafts 98 and
100 on the second side of the bone screw 65 to maintain proper
tensioning of the four bundle graft 78, the apparatus or washer 10
thus seats flush within the counterbore 59, thereby eliminating any
objects extending out beyond the tibia 54. Once the bone screw 65
has been fully secured, the ends of the grafts 94-100 may be
trimmed back within the area 64.
[0064] Turning to FIGS. 7-10, an apparatus or wedge 116 for tibial
fixation of a soft tissue graft according to the teachings of
another embodiment of the present invention is shown. In this
regard, like reference numerals will be used to refer like
structures. Here again, the wedge 116 is preferably made from a
suitable biocompatible material such as titanium, stainless steel,
titanium alloy, cobalt-chrome-molybdenum alloy, polymer, resorbable
polymer, etc.
[0065] The wedge 116 includes a first side 118 and a second side
120. The first side includes a plurality of parallel running teeth
122 each defined by a first vertical sidewall 124 and a second
angled sidewall 126. Each tooth 122 includes three axial or
perpendicular notches 128 formed into the tooth 122 and an edge
130. The notches 128 being perpendicular to the teeth 122 provides
additional surface area, as well as two opposed planes in which to
grab or engage the four bundle graft 78. The edge 130 of each tooth
122 has a slight arcuate shape, as shown clearly in FIG. 9. The
second side 120 of the wedge 116 includes an arcuate shaped
periphery 132 with a threaded face 134 formed therein. The threaded
face 134 is operable to be threadably engaged by an interference
screw, further discussed herein.
[0066] The wedge 116 further includes a first or distal end 136 and
a second or proximal end 138. The distal end 136 includes a rounded
nose 140 having the three notches 128 on the first side 118 and a
V-shaped notch or groove 142 on the second side 120. The proximal
end 138 includes a pair of wings 144 defining an open region 146
which provides for clearance of the interference screw. The wings
144 are angled and sized such that when the wedge 116 is axially
inserted into the tibial tunnel 52, a face 148 of the wings 144
lies substantially flush or along the same plane as the tibia 54.
The size of the wings 144 are also larger than the diameter of the
tibial tunnel 52 such that the wings 144 prevent the wedge 116 from
being axially inserted or drawn into the tibial tunnel 52 more than
a predetermined amount.
[0067] Turning to FIG. 10, a side cross-sectional view of the wedge
116 is shown having a wider or thicker distal end 136 and a thinner
or narrower proximal end 138. The threaded face 134 is also clearly
shown having individual threads 150 formed within the arcuate
periphery 132. The orientation of the thinner proximal end 138
which gets thicker moving out to the distal end 136 compensates or
is complimentary to the shape of the interference screw utilized.
This sizing also provides engagement adjustment by locating the
interference screw either further in along the threaded face 134
near the distal end 136 or conversely locating the interference
screw back towards the proximal end 138, further discussed
herein.
[0068] Referring to FIGS. 11-12, the method for tibial fixation of
the soft tissue graft 78 utilizing the wedge 116 will now be
described. Here again, the soft tissue grafts are initially
harvested and prepared for use in the anterior cruciate ligament
(ACL) reconstruction. Once the grafts have been harvested and
prepared using known techniques, the tibial tunnel 52 is bored
through the tibia 54 and into the femur 56 creating the femoral
tunnel 58. The four bundle graft 78 is then secured within the
femoral tunnel 58 using the bone mulch screw described above. Once
the four bundle graft 78 has been secured within the femoral tunnel
58, the four bundle graft 78 is passed through the tibial tunnel
52.
[0069] With the four bundle graft 78 extending out of the tibial
tunnel 52, the four bundle graft 78 is properly tensioned by
pulling on the proximal end of the four bundle graft 78. With the
four bundle graft 78 properly tensioned, the wedge 116 is
positioned axially in the tibial tunnel 52 below the four bundle
graft 78. The first side 118 having the plurality of teeth 122 are
oriented axially and adjacent to the four bundle graft 78 to
substantially engage and hold the four bundle graft 78 under proper
tensioning against the upper or anterior side 76 of the tunnel 52.
An interference screw 152 having threads 154 which matingly receive
threaded face 134 is axially inserted within the tibial tunnel 52.
An optional guide wire 156 may be utilized which passes through a
bore 158. The guide wire 156 passes from the entrance opening 60
out the exit opening 62 and is used for positioning and aligning
the interference screw 152 during axial insertion of the
interference screw 152.
[0070] With the interference screw 152 properly positioned between
the second side 120 of the wedge 116 and the lower or posterior
sidewall 74 of the tibial tunnel 52, a driver, such as a hex driver
engages the head 162 of the interference screw 152 to axially drive
the interference screw 152 between the second side 120 and the
sidewall 74. As the driver turns the interference screw 152, the
threads 154 of the interference screw 152 engage the threads 150 of
the threaded face 134, as well as the sidewall 74, thereby causing
the interference screw 152 to axially advance from the proximal end
of the tunnel 52 to the distal end of the tunnel 52. As the
interference screw 152 axially advances, the wings 144 prevent the
wedge 116 from being axially drawn into the tibial tunnel 52 by
more than a predetermined amount, as well as maintains the pre-set
tension on the four bundle graft 78. As the interference screw 152
further ascends into the tibial tunnel 52, the teeth 122 further
engage and compress the four bundle graft 78 under the wedge
compression of the interference screw 152. The side cross-section
wedge shape of the wedge 116, as shown in FIG. 10, is complimentary
to the shape of the interference screw 152, such that initial
engagement of the interference screw 152 with the wedge 116
provides a substantially planer uniform force which is
substantially transverse or perpendicular to the tibial tunnel 52.
Upon further driving the interference screw 152 within the tunnel
52, the wedge 116 will provide additional or increased compression
in the distal end 136 as the interference screw 152 passes into the
notched region 142. The plurality of teeth 122 having the
perpendicular notches 128 provide a substantial surface engagement
area to securely axially retain the four bundle graft 78 under
proper tensioning endoscopically. In addition, the enlarged surface
area distributes the tensioning force more uniformly over the graft
78. Still further, by providing a substantially non-moving
engagement member against the graft 78, this reduces the
possibility that the graft 78 may be frayed, slip or cut.
[0071] Referring now to FIGS. 13-15, a proximal end 164 of a wedge
166 according to the teachings of another embodiment of the present
invention is shown. In this regard like reference numerals will be
used to refer to similar structures. It should be noted that the
distal end of the wedge 166 is the same as the distal end 136 of
wedge 116 and the only modification here is to the proximal end
164. In this regard, the proximal end 164 does not include a pair
of wings 144 but includes or defines a pair of notched regions 168
which are operable to be engaged by an endotibial plate grasper
172, shown in FIG. 16, and further discussed herein. The notches or
grasper slots 168 are V-shaped and defined by a bevelled or rounded
end 170 of the wedge 166.
[0072] The endotibial plate grasper 172 includes complementary
tines or tips 174 which engage the notches 168 to firmly grasp and
secure the plate 176. Set back from the tips 174 and adjacent
thereto is an alignment plate 176 sized to be larger than the
tibial tunnel 52 and angled substantially similar to the wings 144.
The plate grasper or instrument 172 further includes a handle 178
having a locking mechanism 180 such that the plate 166 can be
engaged by the tips 174 and locked or held secured by the locking
mechanism 180.
[0073] The method for utilizing the wedge 166 in combination with
the plate grasper 172 will now be described with reference to FIG.
17. Once again, the soft tissue grafts are harvested and prepared
using known techniques. The tibial tunnel 52 and the femoral tunnel
58 are bored through both the tibia 54 and the femur 56. The four
bundle graft 78 is again secured within the femoral tunnel 58 using
known techniques such as the bone mulch screw identified above.
[0074] The four bundle graft 78 extending through the tibial tunnel
52 is then properly tensioned. Once the four bundle graft 78 is
properly tensioned, the instrument 172 engages the notches 168 of
the wedge 166, via the tips 174. With the wedge 166 being firmly
held by the instrument 172, via the locking mechanism 180, the
wedge 166 is axially inserted into the tibial tunnel 52 until the
plates 176 engage the entrance opening 60 of the tibial tunnel 52.
Here again, the teeth 122 transversely engage the four bundle graft
78, as the interference screw 152 is axially driven into the tibial
tunnel 52. The plate 176 prohibits the wedge 166 from being axially
drawn into the tibial tunnel 52 by more than a predetermined amount
thereby maintaining proper graft tensioning, as well as maintaining
the proper alignment of the wedge 166 against the four bundle graft
78. Once the four bundle graft 78 is axially secured within the
tibial tunnel 52, the plate grasper 172 is removed from the wedge
166, thereby providing a properly tensioned and endoscopically
axially secured four bundle graft 78.
[0075] Turning to FIG. 18, as well as referring to FIGS. 1-3, an
apparatus 200 for tibial fixation of a soft tissue graft according
to the teachings of a first preferred embodiment of the present
invention is shown. The apparatus or washer 200 is substantially
similar to the apparatus 10, as shown in FIGS. 1-3, and in this
regard, like reference numerals will be used to identify like
structures. Here again, the fixation apparatus or washer 200
includes the cylindrical body 12 and the plurality of spikes 14.
The cylindrical body 12 includes the cylindrical sidewall 16 having
the bevelled or rounded edges 18 and the substantially flat planar
relief face 20 formed into a portion of the cylindrical sidewall
16. The body 12 further includes the internal bore 22 which
includes a threaded internal sidewall 202 which is able to be
threadably secured to a combination implant and guide instrument,
further discussed herein. The top 26 of the body also includes the
concentric counterbore 28 and the bottom 30 of the body 12 includes
the plurality of spikes 14 extending out from the second side 30.
Here again, the washer 200 may be made from any suitable
bio-compatible material and may also be made in various different
sizes, as with the washer 10, depending on the patient's needs and
the doctor's requirements.
[0076] Referring to FIG. 19, a counterbore guide 204 is shown for
use in preparing of a substantially perpendicular counterbore
relative to a tibial tunnel formed in a tibia, further discussed
herein. The counterbore guide 204 includes a substantially
cylindrical body 206 having a circular handle 208 with a planar
region 210. Extending substantially perpendicular from the
cylindrical body 206 is a positioning bar 212 which is secured to
the cylindrical body 206 by way of a groove formed in the lower
portion of the cylindrical body 206 and a weld. The positioning bar
212 is utilized to engage the medial cortex of the tibia at two
points to provide a predetermined insertion length of the
counterbore guide 204 into the tibial tunnel. Set back from the
positioning bar 212 is a tubular guide bushing 214. The guide
bushing 214 includes a cylindrical bore 216 which mates and is
concentric with a bore 218 defined by the cylindrical body 206. The
guide bushing 214 is secured substantially perpendicular to the
cylindrical body 206 by means of a weld or any other appropriate
fixation. The guide bushing 214 engages the opening of the tibial
tunnel and is operable to permit a guide bore to be formed
substantially perpendicular to the tibial tunnel, further discussed
herein.
[0077] A combination implant and guide instrument 220 which is
operable to implant the washer 200, as well as perform other
purposes, is shown in FIGS. 20 and 21. The instrument 220 includes
a first awl portion 222 and a second guide portion 224. The first
awl portion 222 includes a cylindrically shaped handle 226 having
notched regions 228 and an elongated neck 230. Extending
substantially concentric with the handle 226 is an elongated
cylindrical awl or guide shaft 232 having a distal point or tip
234. The first portion 222 also includes a threaded connector
member 236 which is operable to threadably engage the second
portion 224, further discussed herein.
[0078] The second guide portion 224 also includes a substantially
cylindrical handle 238 having notches 240 and an elongated neck
242. Extending from the substantially cylindrical neck 242 is a
circular impact plate 244. The impact plate 244 may either be
formed integrally with the guide member 224 or may be formed as a
separate annular member having an internal threaded bore which is
threadably received upon a threaded connection member 246. The
threaded connection member 246 extends out beyond the impact plate
244 and is operable to threadably engage threaded sidewall 202 of
the fixation apparatus 200, further discussed herein. Passing
concentrically through the drill guide 224 is a centerbore 248
having an internal threaded sidewall portion 250. The bore 248 is
operable to receive the guide shaft 232, while the threaded
sidewall 250 threadably engages the threaded connection member 236.
In this way, the first portion 222 and the second portion 224 form
the combination implant and guide instrument 220 which is operable
to perform several functions during the implantation procedure.
[0079] Turning to FIGS. 22A-22D, a first preferred method for
tibial fixation of a soft tissue graft will now be described. In
this regard, like reference numerals will be used to identify like
structures, as described in the method set forth in FIGS. 5A-5E.
Initially, soft tissue grafts are harvested and prepared using
known techniques and as previously described. Once the soft tissue
grafts have been harvested and prepared, tunnel or hole placement
is performed, as also previously described. Specifically, the
tibial tunnel or bore 52 is drilled through the tibia 54 and into
the femur 56 creating the femoral tunnel 58.
[0080] Once the tibial tunnel 52 is bored through the tibia 54, the
cylindrical body 206 of the counterbore guide 204 is axially slid
into the entrance opening 60 of the tibial tunnel 52. The
counterbore guide 204 is slidably advanced into the tibial tunnel
52 until the positioning bar 212 engages and is flush against the
medial cortex of the tibial 54 along two contact points. This will
align the guide bushing 214 substantially adjacent and in contact
with the anterior edge 64 or superior portion of the entrance
opening 60 of the tibial tunnel 52. This provides for a stable
three point contact at the entrance opening 60 to the tibial tunnel
52. Additionally, the planar region 210 of the handle 208 acts as a
site mechanism with the guide bushing 214 to insure proper rotation
of the counterbore guide 204 in the tibial tunnel 52.
[0081] Once the counterbore guide 204 is properly positioned within
the tibial tunnel 52 and held by the handle 208, the substantially
three point contact should be made within the oval opening 60 by
way of the positioning bar 212 and the guide bushing 214. This
substantially aligns the guide bushing 214 substantially
perpendicular to the tibial tunnel 52. Once aligned and set, the
first portion 222 of the combination implant and guide instrument
220 is employed. In this regard, the awl or guide shaft 232 is
slidably received within the bore 216 of the guide bushing 214
until the point 234 engages the posterior wall 74 of the tibial
tunnel 52. Once engaged, the first portion 222 is impacted by
striking the handle 226 with a mallet or other appropriate impact
device. The shaft 232 is impacted until the tip 234 is
substantially adjacent to the posterior side of the tibia 54. This
forms a guide bore 254 used to guide the combination implant and
guide instrument 220 and a counterbore bit, further discussed
herein. Once the guide bore 254 is formed, the guide shaft 232 is
removed from the guide bushing 214 and the counterbore guide 204 is
slidably removed from the tibial tunnel 52. This provides a
substantially perpendicular guide bore 254 relative to the tibial
tunnel 52.
[0082] After the guide bore 254 is formed with the punch 222, the
counterbore 66 is formed substantially perpendicular to the tibial
tunnel 52 using a counterbore bit 256 and the drive mechanism 70,
as shown in FIG. 22B. The counterbore bit 256 includes a
substantially cylindrical centering nose 258 which rotatably
engages the guide bore 254. Here again, the counterbore 66 is
preferably bored to remove the anterior edge 64 or the superior
portion of the entrance opening 60 to provide a substantially
perpendicular counterbore 66. In other words, with the guide or
centering nose 258 guided, via the guide bore 254, the counterbore
bit 256 is perpendicular to the posterior wall 74 of the tibial
tunnel 52 and is advanced to the posterior wall 74.
[0083] Once the counterbore 66 has been formed utilizing the
counterbore bit 256, the four bundle graft 78 is first secured
within the femoral tunnel 58 of the femur 56 using one of the many
techniques known in the art and as previously described herein.
Once the graft 78 is secured within the femoral tunnel 58, the
graft 78 extends out through the tibial tunnel 52. The second
portion 224 of the combination implant and guide instrument 220 is
then threadably secured to the first portion 222 by way of the
threaded sidewall 250 and the threaded connection member 236. Once
assembled, the shaft 232 extends out beyond the impact plate 244 by
about 1.25 inches. The threaded connection member 246 is then
threadably engaged with the threaded sidewall 202 of the apparatus
200 to removably secure the apparatus 200 to the impact plate 244.
As the apparatus 200 is threadably secured to the threaded member
246, the impact plate 244 seats within the spherical counterbore 28
and the shaft 232 extends out the center of the fixation apparatus
200.
[0084] The shaft 232 also extends out beyond the spikes 32 to
permit guiding of the apparatus 200 substantially perpendicular to
the tibial tunnel 52. Specifically, the planar relief face 20 of
the apparatus 200 is first positioned inferior to the counterbore
66. The shaft 232 is then slidably engaged within the guide bore
254 until the spikes 32 engage the posterior portion 74 of the
tibial tunnel 52. At this point, the graft 78 is oriented, as shown
in FIG. 5E where the two grafts 94 and 96 of four bundle graft 78
pass along a first side of the shaft 232 and two grafts 98 and 100
pass along a second side of the shaft 232 such that each pair of
grafts are positioned or guided between the longer guide spikes 32
and the guide shaft 232.
[0085] Here again, the fixation apparatus 200 is initially engaged
with only the guide spikes 32 penetrating cancellous bone of the
tibia 54 with the relief face 20 directed toward the entrance
opening 60. Once the guide spikes 32 engage the tibial 54, the four
bundle graft 78 is appropriately tensioned by pulling the four
bundle graft 78 under the engagement spikes 36 within the
counterbore 66 and out the area 102 defined by the relief 20 (see
FIG. 5E) without binding on the sidewall 16 or the counterbore 66.
Once proper tension is achieved on the four bundle graft 78, the
apparatus 200 is fully implanted or nested within the counterbore
66 by striking the handle 226 with a mallet or other appropriate
driving device, as shown clearly in FIG. 22C. Upon seating the
apparatus 200, the engagement spikes 36 penetrate the two grafts 94
and 96 on the first side of the guide shaft 232 at multiple sights
and the two grafts 98 and 100 on the second side of the guide shaft
232 to maintain the proper tensioning of the four bundle graft 78.
This seats the fixation apparatus 200 flushly within the
counterbore 66, thereby eliminating any objects extending out
beyond the tibia 54.
[0086] Once the apparatus 200 is fully nested within the
counterbore 66 or the posterior wall 74 of the tibial tunnel 52,
the first portion 222 of the combination implant and guide
instrument 220 is threadably disengaged from the second portion
224. With the second portion 224 still threadably secured to the
apparatus 200, this provides a guide substantially perpendicular to
the tibial tunnel 52, via the bore 248, passing through the second
portion 224. A drill bit 260 driven by the driver 70 is then guided
through the bore 248, between the grafts 94 and 96 and 98 and 100
and down through the guide bore 254, shown in FIG. 22D. The drill
bit 260 enlarges the guide bore 254 for receipt of the low profile
compression screw 108, shown in FIG. 5D. Once the bore 262 is
drilled into the tibia 54 to the posterior cortex region, the bore
262 may then be tapped with an appropriate tap, should this be
desired. The length of the screw 108 is then determined using any
conventional measuring instrument. Once selected, the low profile
compression screw 108 is passed through the apparatus 200 and
threaded into the bore 262 to complete the fixation of the
apparatus 200.
[0087] Referring now to FIG. 23, a second preferred embodiment of
the counterbore guide 204N is shown. In this regard, like reference
numerals will be used to identify like structures with respect to
the counterbore guide 204. The counterbore guide 204N is
substantially the same as the counterbore guide 204, except that
the counterbore guide 204N includes or defines a slot 264 passing
through the cylindrical body 206 and a slot 266 passing through the
guide bushing 214. Each slot 264 and 266 enables a guide wire,
further discussed herein, to be slidably passed through each slot
and out from the counterbore guide 204N.
[0088] A second combination implant and guide instrument 270
according to the teachings of a second preferred embodiment of the
present invention is shown in FIG. 24, which may be used in place
of the instrument 220. The instrument 270 includes a substantially
cylindrical handle 272 having notches 274 and an elongated tubular
shaft 276. The shaft 276 defines a substantially cylindrical bore
278 passing axially through the shaft 276. The bore 278 includes a
threaded sidewall portion 280 which is operable to be threadably
engaged by a threaded connector member 282 extending from the
handle 272. Positioned at the end of the shaft 276 opposite the
handle 272 is a circular impact head or plate 284 having a
substantially spherical impact face 286 and a threaded connection
member 288. The implant plate 284 may be a separate member threaded
on the connection member 288 or integral with the shaft 276. The
connection member 288 threadably engages the threaded sidewall 202
of the apparatus 200, while the spherical face 286 nestingly rests
within the counterbore 28.
[0089] A second preferred method for tibial fixation of a soft
tissue graft which employs the counterbore guide 204N and the
combination implant and guide instrument 270 is shown in FIGS.
25A-25C. Here again, like reference numerals will be used to
identify like structures. Once the graft 78 has been harvested and
prepared using the known techniques, the tibial tunnel 52 is again
drilled through the tibia 54 and into the femur 56 to form the
femoral tunnel 58. As shown in FIG. 25A, the counterbore guide 204N
is axially slid into the entrance opening 60 of the tibial tunnel
52 with the positioning bar 212 and the guide bushing 214 coming to
rest against the opening 60. Once properly positioned, a
conventional guide wire 290 is passed through the guide bushing 214
and fixedly driven into the tibia 54, via the driver 70 to create a
guide box that secures the guide wire 290. Once secured to the
tibia 54, the counterbore guide 204N is slidably removed from the
tibial tunnel 52 as the guide wire 290 remains in place
substantially perpendicular to the tibial tunnel 52. As the
counterbore guide 204N is slidably removed from the tibial tunnel
52, the guide wire 290 exits through the slots 266 and 264,
respectively.
[0090] The counterbore 66 is again formed by the use of a
counterbore bit 292 which is driven by the driver 70. The
counterbore bit 292 includes an elongated shaft 294 and includes
and defines a cylindrical bore 296 passing through the entire
counterbore bit 292. To insure that the counterbore bit 292 is
aligned substantially perpendicular to the tibial tunnel 52, the
counterbore bit 292 is slidably inserted over the guide wire 290
and rotatably advanced to form the counterbore 66, shown clearly in
25B, as the guide wire 290 passes up through the counterbore bit
292.
[0091] Once the counterbore 66 is formed, the combination implant
and guide instrument 270 threadably receives the apparatus 200, via
the threaded sidewall 202 and the threaded connector member 288.
The impact face 284 nestingly seats within the counterbore 28 as
the apparatus 200 threadably engages the threaded connector member
288. The apparatus 200 is again aligned substantially perpendicular
to the tibial tunnel 52 by means of the guide wire 290. In this
regard, the guide wire 290 extends through the apparatus 200 and
into the bore 278 of the instrument 270 so that the instrument 270
is slidably guided by the guide wire 290 substantially
perpendicular to the tibial tunnel 52. Here again, the spikes 32
are first set in the posterior wall 74 of the tibial tunnel 52 with
the planar face 20 facing inferiorly. The graft 78 is again
tensioned as previously described and the apparatus 200 is then
fully seated by impacting the handle 272 with a mallet or other
appropriate device.
[0092] Once the apparatus 200 is fully seated within the
counterbore 66, the handle 274 is threadably removed from the shaft
276, via the threaded connector member 282, thereby exposing the
bore 278. With the drill guide shaft 276 still threadably secured
to the apparatus 200, the bore 278 guides the drill bit 260 driven
by the driver 70, as shown similarly in FIG. 22D to form the
enlarged bore 262. The low profile compression screw 108 is then
inserted into the bore 262 to complete the fixation of the
apparatus 200 within the counterbore 66.
[0093] The combination implant and guide instrument 220 performs at
least three functions consisting of forming the guide bore 254,
implanting the fixation apparatus 200 and guiding the drill bit
260. The combination implant and guide instrument 270 performs at
least two functions including implanting the fixation apparatus 200
and guiding the drill bit 260. Accordingly, use of the combination
implant and guide instrument 220 or 270 reduces the amount of
separate instrumentation required to secure the soft tissue graft
78, as well as reduces or eliminates additional steps in the
technique. Additionally, by maintaining one portion of each
instrument 220 or 270 secured to the fixation apparatus 200 during
the implant procedure, further accuracy is achieved. Further
accuracy is also achieved by use of the guide shaft 232 or the
guide wire 290 to maintain and form the counterbore 66
substantially perpendicular to the tibial tunnel 52, as well as
insure that the apparatus 200 is impacted substantially
perpendicular to the tibial tunnel 52.
[0094] The foregoing discussion discloses and describes merely
exemplary embodiments of the present invention. One skilled in the
art will readily recognize from such discussion, and from the
accompanying drawings and claims, that various changes,
modifications and variations can be made therein without departing
from the spirit and scope of the invention as defined in the
following claims.
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