U.S. patent application number 13/431459 was filed with the patent office on 2012-09-27 for materials and methods for improved bone tendon bone transplantation.
This patent application is currently assigned to RTI BIOLOGICS, INC.. Invention is credited to Kevin C. Carter, Michael Esch, Jim Gross, Paul LaRochelle.
Application Number | 20120245687 13/431459 |
Document ID | / |
Family ID | 23911497 |
Filed Date | 2012-09-27 |
United States Patent
Application |
20120245687 |
Kind Code |
A1 |
Carter; Kevin C. ; et
al. |
September 27, 2012 |
MATERIALS AND METHODS FOR IMPROVED BONE TENDON BONE
TRANSPLANTATION
Abstract
Disclosed herein is an improved Bone Tendon Bone graft for use
in orthopedic surgical procedures. Specifically exemplified herein
is a Bone Tendon Bone graft comprising one or more bone blocks
having a groove cut into the surface thereof, wherein said groove
is sufficient to accommodate a fixation screw. Also disclosed is a
a method of harvesting grafts that has improved efficiency and
increases the quantity of extracted tissue and minimizes time
required by surgeon for implantation.
Inventors: |
Carter; Kevin C.;
(Gainesville, FL) ; Esch; Michael; (Alachua,
FL) ; LaRochelle; Paul; (Satelite Beach, FL) ;
Gross; Jim; (Alachua, FL) |
Assignee: |
RTI BIOLOGICS, INC.
Alachua
FL
|
Family ID: |
23911497 |
Appl. No.: |
13/431459 |
Filed: |
March 27, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10846399 |
May 14, 2004 |
8167943 |
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13431459 |
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09528034 |
Mar 17, 2000 |
6805713 |
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10846399 |
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09481319 |
Jan 11, 2000 |
6497726 |
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09528034 |
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Current U.S.
Class: |
623/13.14 |
Current CPC
Class: |
A61F 2002/0882 20130101;
A61F 2002/2839 20130101; A61F 2002/087 20130101; A61F 2/0811
20130101; A61F 2/08 20130101; A61F 2230/0069 20130101; A61B
2217/007 20130101; A61B 17/1637 20130101; A61B 17/1635 20130101;
A61F 2002/4649 20130101; A61F 2310/00359 20130101; A61B 17/1675
20130101; A61F 2002/0858 20130101 |
Class at
Publication: |
623/13.14 |
International
Class: |
A61F 2/08 20060101
A61F002/08 |
Claims
1-18. (canceled)
19. A allograft bone-tendon-bone graft useful in orthopedic surgery
comprising a first substantially cylindrical bone block, a second
substantially cylindrical bone block, and a tendon interconnecting
said first substantially cylindrical bone block to said second
substantially cylindrical bone block by naturally occurring
tendon-to-bone attachments; wherein said first and second
substantially cylindrical bone blocks each further comprise a
substantially cylindrical outer surface and one or more end
surfaces; and wherein said tendon runs along at least a portion of
the length of the substantially cylindrical outer surface and said
tendon forms at least a portion of the substantially cylindrical
outer surface of at least one of said bone blocks.
20. The allograft bone-tendon-bone graft of claim 1, wherein said
tendon is obtained from human patellar tendon.
21. The allograft bone-tendon-bone graft of claim 1, wherein one or
both of said substantially cylindrical bone blocks have ends that
are rounded.
22. The allograft bone-tendon-bone graft of claim 1, wherein one or
both of said substantially cylindrical bone blocks have ends that
are flat.
23. The allograft bone-tendon-bone graft of claim 1, wherein the
source of the first substantially cylindrical bone block is the
tibia or the patella.
24. The allograft bone-tendon-bone graft of claim 1, wherein said
graft is processed to minimize the level of antigenic agents or
potentially pathogenic agents.
25. The allograft bone-tendon-bone graft of claim 1, wherein one or
both of said substantially cylindrical bone blocks further
comprises a graft manipulation hole.
26. The allograft bone-tendon-bone graft of claim 1, wherein one or
both of said substantially cylindrical bone block is a cylindrical
dowel.
27. The allograft bone-tendon-bone graft of claim 8, wherein the
cylindrical dowel has a diameter between 8 and 12 mm.
28. The allograft bone-tendon-bone graft of claim 1, wherein one or
both of said substantially cylindrical bone blocks comprises a
groove to position a fixation screw.
29. The allograft bone-tendon-bone graft of claim 10, wherein said
groove is a radius cut extending the length of the bone block.
30. The allograft bone-tendon-bone graft of claim 10, wherein said
groove has a surface with a thread profile cut therein.
31. A allograft bone-tendon graft suitable for fixation in a bone
tunnel during orthopedic surgery on a human comprising a
substantially cylindrical bone block and a tendon attached to said
substantially cylindrical bone block by a naturally occurring
tendon-to-bone attachment, wherein the bone block comprises a
substantially cylindrical outer surface, configured for filling of
dead space in said bone tunnel and having a diameter between 8 and
12 mm; and wherein said tendon extends along at least a portion of
the length of the substantially cylindrical outer surface and said
tendon forms at least a portion of the substantially cylindrical
outer surface.
32. The allograft bone-tendon graft of claim 13, wherein said
tendon is obtained from the group consisting of human patellar
tendon, human quadriceps tendon and human Achilles tendon.
33. The allograft bone-tendon graft of claim 13, wherein said
substantially cylindrical bone block comprises a groove to position
a fixation screw.
34. The allograft bone-tendon graft of claim 15, wherein said
groove is a radius cut extending the length of the bone block.
35. The allograft bone-tendon graft of claim 15, wherein said
groove on said substantially cylindrical bone block has a surface
with a thread profile cut therein.
36. A allograft bone-tendon graft suitable for filling dead space
within a substantially cylindrical bone tunnel in a human patient,
comprising a bone block and a tendon attached to the bone block by
a naturally occurring tendon-to-bone attachment, wherein the bone
block has a substantially cylindrical outer surface and has a
diameter between 8 and 12 mm; and wherein said tendon forms at
least a portion of the substantially cylindrical outer surface.
37. The allograft bone-tendon graft of claim 18, wherein said
tendon is obtained from the group consisting of human patellar
tendon, human quadriceps tendon and human Achilles tendon.
38. The allograft bone-tendon graft of claim 18, further comprising
a groove to position a fixation screw.
39. The allograft bone-tendon graft of claim 18, further comprising
at least one graft manipulation hole.
40. A allograft bone-tendon graft useful in orthopedic surgery
comprising one or more bone blocks and a tendon attached to at
least one of said one or more bone blocks by a naturally occurring
tendon-to-bone attachment wherein at least one of said bone blocks
has a shape comprising a round cross section of constant radius,
and wherein said constant radius is essentially the same at two or
more distinct cross sections along the length of said bone block
and wherein said bone block has a diameter between 8 and 12 mm; and
wherein said tendon forms at least a portion of the round cross
section of constant radius.
41. The allograft bone-tendon graft of claim 22, wherein said
tendon is obtained from the group consisting of human patellar
tendon, human quadriceps tendon and human Achilles tendon.
42. The allograft bone-tendon graft of claim 22, wherein said one
or more bone blocks comprises a groove to position a fixation
screw.
43. The allograft bone-tendon graft of claim 24, wherein said
groove is a radius cut extending the length of the bone block.
44. The allograft bone-tendon-bone graft of claim 24, wherein said
groove has a surface with a thread profile cut therein.
45. The allograft bone-tendon graft of claim 22, wherein said
tendon has a first end and a second end, and wherein said one or
more bone blocks comprises a first bone block attached to said
first end and a second bone block attached to said second end.
46. The allograft bone-tendon graft of claim 27, wherein said first
bone block is derived from a patella, said second bone block is
derived from a tibia, and said tendon is derived from a patellar
tendon.
Description
[0001] The present application is a continuation of U.S. patent
application Ser. No. 10/846,399 (now allowed), which was filed May
14, 2004, which is a continuation of U.S. patent application Ser.
No. 09/528,034 (now U.S. Pat. No. 6,805,713), which was filed Mar.
17, 2000, which is a continuation-in-part of U.S. patent
application Ser. No. 09/481,319 (now U.S. Pat. No. 6,497,726),
which was filed Jan. 11, 2000. The entire text of the
aforementioned applications is incorporated herein by reference in
its entirety.
BACKGROUND OF THE INVENTION
[0002] Orthopedic medicine is increasingly becoming aware of the
vast potential and advantages of using bone/tendon/bone grafts to
repair common joint injuries, such as Anterior Cruciate Ligament
(ACL) or Posterior Cruciate Ligament (PCL) tears. One technique
that is currently used for repairing these types of injuries
involves surgically reconnecting the torn portions of a damaged
ligament. However, this technique is often not possible, especially
when the damage to the ligament is extensive. To address situations
where the damage to the joint ligaments is severe, another
technique commonly performed involves redirecting tendons to
provide increased support to a damaged knee. These conventional
techniques are not without their shortcomings; in most cases, the
repaired joint lacks flexibility and stability.
[0003] The recent utilization of bone/tendon grafts has
dramatically improved the results of joint repair in cases of
severe trauma. Even in cases of extensive damage to the joint
ligaments, orthopedic surgeons have been able to achieve 100
percent range of motion and stability using donor bone/tendon
grafts.
[0004] Despite these realized advantages, there have been some
difficulties encountered with utilizing bone/tendon grafts. For
example, surgical procedures involving transplantation and fixation
of these grafts can be tedious and lengthy. Currently,
bone/tendon/bone grafts must be specifically shaped for the
recipient during surgery, which can require thirty minutes to over
an hour of time. Further, surgeons must establish a means of
attaching the graft, which also takes up valuable surgery time.
[0005] Another difficulty associated with using bone/tendon grafts
is that there is a limited supply and limited size range available.
This can result in a patient having to choose an inferior procedure
simply based on the lack of availability of tissue. Accordingly,
there is a need in the art for a system that addresses this and the
foregoing concerns.
SUMMARY OF THE INVENTION
[0006] The subject invention concerns a novel bone tendon bone
graft (BTB) that facilitates an easier and more efficient surgery
for reconstructing ligaments in a joint. One aspect of the subject
invention pertains to a BTB that comprises a tendon and two bone
blocks positioned at opposite ends of the tendon, wherein the bone
blocks are pre-shaped for uniform and consistent alignment into a
recipient bone.
[0007] In a specific aspect, the subject invention pertains to a
bone tendon bone graft useful in orthopedic surgery comprising one
or more bone blocks, and a tendon attached to said one or more bone
blocks; wherein said one or more bone blocks is cut to provide a
groove sufficient to accommodate a fixation screw. Alternatively,
the subject invention pertains to a bone tendon bone graft useful
in orthopedic surgery comprising one or more bone blocks and a
tendon attached to said one or more bone blocks, wherein said one
or more bone blocks is pre-shaped into a dowel.
[0008] A further aspect of the subject invention pertains to a
method of obtaining a plurality of bone tendon bone grafts
comprising excising a first bone plug having attached thereto a
tendon or ligament; and excising a second bone plug having attached
thereto a tendon or ligament; wherein said first bone plug and said
second bone plug are derived from contiguous bone stock and overlap
such that excision of said first bone plug or said second bone plug
forms a groove in the bone plug that is excised subsequent to the
other.
[0009] In yet another aspect, the subject invention pertains to a
method of conducting orthopedic surgery on a human or an animal
comprising obtaining a bone tendon bone graft, said graft
comprising a tendon or ligament having two ends, and one or more
bone blocks attached to said tendon or ligament, wherein at least
one of said one or more bone blocks has a groove suitable for
accommodating a fixation screw.
[0010] An alternative aspect of the invention pertains to an
implant comprising a bone block and a tendon, wherein the bone
block comprises a groove for accommodating a fixation screw.
[0011] These and other advantageous aspects of the subject
invention are described in further detail below.
DETAILED DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 shows an embodiment of a BTB having a groove with a
thread profile disposed thereon.
[0013] FIG. 2 shows a side view of three different embodiments of
BTBs in accordance with the subject invention.
[0014] FIG. 3 depicts a frontal view of a donor area for harvesting
BTBs in accordance with the teachings herein.
[0015] FIG. 4 is a depiction of another embodiment of the invention
illustrating a reconstruction of an injured area through
implantation of a BTB in accordance with the teachings herein.
[0016] FIG. 5 shows a side view of a BTB core cutter of the subject
invention designed for harvesting BTB grafts.
[0017] FIG. 6A shows a close up view of a teeth configuration that
is less desired for use with the subject invention.
[0018] FIG. 6B shows a close up view of a preferred embodiment of
the teeth of the embodiment shown in FIG. 5.
[0019] FIG. 7 is a blown up view of the circled region as shown in
FIG. 5.
[0020] FIG. 8 is three dimensional side view of a further
embodiment of the subject BTB that comprises one block that is
tapered on both ends.
DETAILED DESCRIPTION OF THE INVENTION
[0021] Referring to FIG. 1, there is shown an embodiment directed
to a BTB 100 comprising a first bone block 110 and a second bone
block 120 interconnected by a tendon 130, wherein each bone block
has been pre-shaped into dowels. The term "tendon" as used herein
is intended in its broad sense and refers to fibrous connective
tissue for use in grafts, such as, but not limited to, tendons,
ligaments and demineralized bone. The terms "BTB" or "bone tendon
bone graft" as used herein refer to a graft implant that comprises
one or more tendon portions and one or more bone portions. The BTB
is preferably isolated from the knee of a donor. However, in view
of the teachings herein, those skilled in the art will readily
appreciate that other areas of the body are suitable, albeit less
preferred, for harvesting BTBs according to the subject invention,
such as, but not limited to, the Achilles tendon/calcaneus region
or shoulder region. In addition to BTBs having a tendon portion
derived from naturally occurring tendon or ligament harvested from
a donor, other examples of suitable implants would be readily
appreciated by those skilled in the art, such as, but not limited
to, segmentally demineralized bone (International Pub. No.
WO/99/21515). In a more preferred embodiment, one of the bone
blocks is derived from the patella while the other is derived from
the end of the tibia, and the tendon is derived from the patellar
tendon.
[0022] To facilitate placement of a fixation screw, the dowels are
preferably machined down the length of the bone block to form
radius cuts 115, 125. The radius cuts 115, 125 aid in the
attachment of the graft to recipient bone because they provide a
groove to position a fixation screw, which results in increased
surface area at the contact between the bone block and the screw.
The radius cuts 115, 125 provide the additional advantage of
increasing the pull out loads of the bone block, as well as filling
of "dead" space in the tunnel.
[0023] Fixation methods known in the art can be used in accord with
the principles of the subject invention, which include, but are not
limited to, staples, buttons, screw and washer, interference
screws, and self-taping screws. In a preferred embodiment, fixation
is accomplished by interference screws and/or self-taping screws.
In an even more preferred embodiment, the radius cuts 115, 125
contain a thread profile 135 that matches the thread profile of the
fixation screw, thereby further increasing the stability of
fixation.
[0024] Referring now to FIG. 2, three different embodiments of the
subject BTBs are shown. FIG. 2A shows an embodiment that comprises
a basic configuration of the subject BTBs. Bone blocks 210 and 220
are in a pre-shaped dowel form with no groove thereon, and are
connected by tendon 100. FIG. 2B shows another version of the BTB,
wherein the bone blocks are pre-shaped into dowels with tapered
ends. Bone block 212 is a dowel that has a proximal tapered region
216 in relation to tendon 200, and bone block 214 is preshaped into
a dowel that has a distal tapered region 218 in relation to tendon
200. FIG. 2C illustrates a preferred version of the invention,
which has a bone block 230 with a proximal tapered region 239 and a
groove 238 positioned on the bone block 230. This version also
comprises a second bone block 234 with a distal tapered region and
a groove 236 positioned on bone block 234 as well. The embodiments
shown in FIGS. 2B-C are tapered such that implantation into a
pre-formed tunnel in recipient to bone is preferred to occur in the
direction of the arrow (see also FIG. 4).
[0025] Referring to FIG. 3, an illustration of a donor area 300 is
depicted, wherein three separate grafts 335, 345, and 355 are
harvested. As shown, the three different grafts individually have
at least one bone block 330, 340, and 350. While the sequence of
harvesting the grafts is not critical, preferably, graft 335 is
excised first, followed by excision of the outside grafts 345, 355.
Excising graft 335 first results in the automatic cut in the other
donor areas, thereby producing a groove in the bone blocks 340, 350
of the other grafts upon excision. In a preferred embodiment, the
donor area is located at the top of the Tibia at the insertion of
the patellar tendon 320. In an even more preferred embodiment, the
donor area extends the length of the patellar tendon to the
patella, wherein bone blocks are excised from the patella.
[0026] The bone blocks can be extracted with the use of
conventional tools and protocols routinely practiced in the art,
such as core cutter and hole saws. In a preferred embodiment, the
bone blocks can be extracted through the use of a BTB bone cutter
according to the teachings further described below.
[0027] The extracted bone blocks 330, 340, and 350 are generally
shaped like a plug or dowel and are preferably further shaped by
machining through conventional methods known in the art. In a
specific embodiment the dowel is machined into dimensions suitable
for various surgical procedures. The machining is preferably
conducted on a graduated die, a grinding wheel, a lathe, or
machining tools may be specifically designed and adapted for this
purpose in view of the teachings herein. Preferred dimensions for
the dowels include 8 mm, 9 mm, 10 mm, 11 mm, and 12 mm in diameter.
Reproducibility of the product dimensions is an important feature
for the successful use of such grafts in the clinical setting.
[0028] In a specific embodiment, the subject invention is directed
to a method of repairing an injured cruciate ligament in the knee
involving the implantation of a BTB. FIG. 4 illustrates this
procedure, and shows a femur 400 and tibia 410 having tunnels
formed therein, 466 and 462, respectively, for receiving BTB 430,
which comprises two bone blocks 432 and 434 connected by tendon
433. To aid in guiding the BTB 430 through tunnel 462, sutures 460
are optionally engaged to bone block 432, which allow a surgeon to
pull the BTB 430 through tunnel 462 where the sutures 460 can then
be removed. Once the BTB 430 is properly situated in tunnels 462
and 466, the BTB 430 is secured in the recipient bone by
interference screws 440. The interference screws 440 are preferably
self taping and are engaged by rotation in the space between
grooves 438 and 436 and the inner walls of tunnels 466 and 462,
respectively. In an even more preferred embodiment, the BTB can be
pre-marked with alignment markings. Such markings can be positioned
on the BTB to aid the surgeon in visualizing the depth of the BTB
in the tunnels formed for receiving the BTB, as well as visualizing
bone ligament junctions and rotation of the BTB.
[0029] Referring now to FIGS. 5-7, another embodiment of the
subject invention is shown that is directed to a BTB harvesting
device, such as core cutter 500 that comprises a shaft 502 having a
first end 503 and a second end 505. The first end 503 of the shaft
502 preferably has a cavity 501 longitudinally disposed thereon,
which is designed for engaging a drill, such as by insertion of a
Jacob's chuck attached to a power drill (e.g., Dupuy). The second
end 505 of the shaft 502 can be attached to a first end 512 of a
hollow cylinder 504. The second end 514 of the cylinder 504
preferably has teeth 510 disposed thereon. In a preferred
embodiment the cylinder has at least one slot 506 disposed on its
surface to aid in the removal of the cut graft tissue from the core
cutter 500. The slot 506 also provides a means to wash the graft
during the extraction procedure to thereby decrease the chance of
frictional burning of the graft. In a preferred embodiment, the
shaft 502 is approximately 90 mm in length, the cylinder 504 is
approximately 50 mm in length, and the slot 506 is approximately 30
mm in length. In an even more preferred embodiment, the first end
of the hollow cylinder 512 has a chamfered portion 522 which angles
down to the shaft 502.
[0030] A blown up view of the core cutter teeth 510 is illustrated
in FIG. 6. It is preferred that the radius of the teeth A and rake
angle of the teeth B (also referred to as a bottom angle) are of
appropriate values as to avoid failure (e.g. bending or breaking)
of the teeth, as well as undesired damage to the graft. For
example, FIG. 6A shows an unacceptable tooth pattern wherein the
radius A and bottom angle B are too large, resulting in
insufficient support structure for the tooth and inevitable
failure. According to the subject invention, a core cutter having a
diameter of approximately 10-11 mm preferably has approximately 14
teeth, with a tooth radius A of approximately 20-30 mm (25 mm being
more preferred) and a bottom angle B of approximately 10-20 degrees
(15 degrees being more preferred). For core cutters designed for
smaller or larger bone blocks, the foregoing dimensions are
preferably maintained, while the number of teeth are appropriately
decreased or increased. In a preferred embodiment, the number of
teeth are decreased or increased by two for every millimeter below
or above, respectively, the 10-11 mm cylinder diameter. For
example, a core cutter having a 12 mm cylinder diameter would
preferably have about 16 teeth.
[0031] A blown up view of an end section (circle shown in FIG. 5)
of the cylinder 504, is shown in FIG. 7, which illustrates a
preferred embodiment of the cylinder 504 wherein the internal
diameter (ID) is decreased slightly by adding a relief thickness
520 to the inner surface of the cylinder 504. This embodiment
provides an additional convenience when using a size gauging device
(e.g. ring) for selecting extracted bone blocks that are within
desired parameters. For example, the selection of a BTB through a
10 mm sized gauging device would preferably require the BTB to be a
slight fraction smaller in diameter than the gauging device,
otherwise any insignificant irregularity in the shape of the BTB
might cause it to fail to pass through the gauging device. The
relief thickness 520 decreases the ID of the cylinder 504, thereby
effectuating this slight modification to the BTB.
[0032] Shown in FIG. 8 is a further embodiment 800 of the subject
BTB that is especially adapted for implantation during knee
surgery, wherein the implantation and securement of the BTB is
bi-directional. BTB embodiment 800 comprises one bone block portion
810 and one tendon portion 820. A preferred area from which
embodiment 800 is harvested would be the heel, thigh, or shoulder.
More preferably, the area from which embodiment 800 is harvested is
the heel or thigh, whereby tendon portion 820 is derived from an
Achilles tendon or quadriceps tendon of a donor. The bone block
portion 810 comprises two ends 812 and 814 which both comprise a
tapered region 816 and 818, respectively. The presence of the two
tapered regions 812 and 814 allows for the BTB embodiment 800 to be
inserted and secured bi-directionally, which means, for example,
implantation in either the tibial 462 or femoral 466 tunnels as
discussed above in reference to the method diagrammed in FIG. 4. Of
course, the site of implantation could be approached from a
superior point of entry, i.e., establishing a through-tunnel in the
femur as opposed to the tibia; BTB embodiment 800 would be suitable
for securement in either tunnels in such alternative procedure as
well. Further, the bone block 810 can be provided with a groove 850
to aid in the securement of the implant. In addition, during
implantation, it may be desirable to have a means for manipulating
the implant, such as by sutures or graft insertion tools.
Accordingly, BTB embodiment 800 is provided with preformed graft
manipulation holes 852 and 854 for receiving a suture and/or graft
insertion tools. By way of example of illustrating the orientation
of the graft manipulation holes, holes 852 and 854 are shown as
being vertical or horizontal, respectively, to the axis of the bone
block 810. The preformed graft manipulation holes can be made by
conventional methods, such as by drilling. Appropriate tools for
insertion into preformed holes 852 and 854 will easily be
appreciated by those skilled in the art. Preferably, the graft
insertion tool(s) used comprise an end having a shape and size
suitable for insertion into the graft manipulation holes.
[0033] Those skilled in the art will appreciate that the graft may
be an autograft, allograft, or xenograft. Xenograft implants may
further require treatments to minimize the level of antigenic
agents and/or potentially pathogenic agents present in the graft.
Techniques now known, or those which are later developed, for
preparing tissue such that it is suitable for and not rejected by
the recipient are incorporated herein. In cases where the graft is
an allograft or xenograft, a donor is preferably screened for a
wide variety of communicable diseases and pathogens, including
human immunodeficiency virus, cytomegalovirus hepatitis B,
hepatitis C and several other pathogens. These tests may be
conducted by any of a number of means conventional in the art,
including, but not limited to, ELISA assays, PCR assays, or
hemagglutination. Such testing follows the requirements of the
following associations: (a) American Association of Tissue Banks.
Technical Manual for Tissue Banking, Technical
Manual-Musculoskeletal Tissues, pages M19-M20; (b) The Food and
Drug Administration, Interim Rule, Federal Register, Vol. 58, No.
238, Tuesday, December 14, Rules and Regulations, 65517, D.
Infectious Disease Testing and Donor Screening; (c) MMWR, Vol. 43,
No. RR-8, Guidelines for Preventing Transmission of Human
Immunodeficiency Virus Through Transplantation of Human Tissue and
Organs, pages 4-7; (d) Florida Administrative Weekly, Vol. 10, No.
34, Aug. 21, 1992, 59A-1.001-014, 59A-1.005(12)(c), F.A.C.,
(12)(a)-(h), 59A-1.005(15, F.A.C., (4) (a)-(8). In addition to a
battery of standard biochemical assays, the donor, or their next of
kin can be interviewed to ascertain whether the donor engaged in
any of a number of high risk behaviors such as having multiple
sexual partners, suffering from hemophilia, engaging in intravenous
drug use etc. Once a donor has been ascertained to be acceptable,
the tissue for obtention of the BTBs as described above are
recovered and cleaned.
[0034] The teachings of all patents and publications cited
throughout this specification are incorporated by reference in
their entirety to the extent not inconsistent with the teachings
herein.
[0035] It should be understood that the examples and embodiments
described herein are for illustrative purposes only and that
various modifications or changes in light thereof will be suggested
to persons skilled in the art and are to be included within the
spirit and purview of this application and the scope of the
appended claims.
Example 1
Procedure for Harvesting of Crude BTB for Patellar Tendon Tibial
Donor
[0036] A BTB was harvested according to the following
procedure:
[0037] 1. Using blunt and sharp dissection remove the three layers
of connective tissue from the anterior portion of the tendon.
[0038] 2. Using scalpel or scissors cut along the medial and
lateral borders of the tendon. Use the scissors to bluntly dissect
under the tendon to separate it from the fat layer.
[0039] 3. Cut around the Patellar block to separate it form the
proximal tibia and distal femur. Leave approximately 4 cm of
quadriceps tendon attached to the patellar if required. If no
quadriceps tendon attachment is specified then remove quadriceps
from patellar completely using sharp dissection.
[0040] 4. Pull tendon away from capsule and remove all excess
adipose tissue to the point of tibial insertion.
[0041] 5. With a saw make a transverse cut through approximately
the tibial tuberosity about 30 mm from the tendon insertion point.
Make a similar cut about 5 mm proximal to the insertion point,
which will remove the tibial plateau.
[0042] 6. With a saw, cut and square the sides of the tibia bone
block even with the tendon.
[0043] 7. With a saw cut and square the patella block on three
sides (if quadriceps tendon is still attached square off only the
medial and lateral sides).
[0044] 8. Remove all extraneous soft tissue and cartilage from the
patella, tibial tuberosity and tendon.
[0045] 9. To hemisect the patellar tendon use a scalpel to divide
the tendon into a medial half and a lateral half. Each half should
be 14 mm or greater unless otherwise specified.
[0046] 10. Using a saw, split the patella block and the tibia block
in half following the same medial/lateral line used to split the
tendon.
[0047] 11. Thoroughly lavage the bone blocks with sterile water or
saline.
Example 2
Procedure for Forming Patellar Tendons with Preshaped Dowels for
Patellar Tendon Tibial Donor
[0048] A BTB was harvested according to the following
procedure:
[0049] 1. Using blunt and sharp dissection remove the three layers
of connective tissue from the anterior portion of the tendon.
[0050] 2. Using a scalpel or scissors cut along the medial and
lateral borders of the tendon to separate it from the fat
layer.
[0051] 3. Cut around the Patellar block to separate it from the
proximal tibia and distal femur.
[0052] 4. Pull tendon away from capsule and remove all excess
adipose tissue to the point of tibial insertion.
[0053] 5. With a saw make a transverse cut through the tibial
tuberosity about 30 mm from the tendon insertion point. Make a
similar cut just proximal to the insertion point removing the
tibial plateau. Make another cut across the coronal plane 20-30 mm
posterior from the insertion point.
[0054] 6. With a saw square the sides of the tibia bone block.
[0055] 7. With a saw cut and square the patella block on the three
sides.
[0056] 8. Attach a vice to the tabletop. Place the tibia bone block
in the vice so that it holds it along the proximal and distal
sides. The distal side of the bone block should be facing the
processor with the tendon going away from them. Tighten the vice so
that it holds the bone securely but does not crush it.
[0057] 9. Attach a Jacob's chuck to a drill and insert the
appropriate size cutter. Tighten the chuck with the chuck key.
Note: At least two plugs should be cut from each bone block.
[0058] 10. Position the cutter against the bone block so the teeth
of the cutter will skim just over the top of the tendon without
catching the tendon. Position the cutter so that the maximum
attachment is obtained throughout the length of the bone plug.
[0059] 11. Turn drill on and begin drilling the plug. When the
cutter nears the end of the plug, slow the drill until the cutter
just breaks through the proximal end of the bone block. Remove the
plug from the cutter and drill without damaging the tendon.
[0060] 12. Repeat steps 10 and 11 for the second plug.
[0061] 13. Using scissors or a scalpel hemisect the tendon into
medial and lateral halves.
[0062] 14. Remove the excess bone from the table vice and place the
patella bone block into the vice so that it holds it along the
medial and lateral sides of the block. The proximal side of the
patella should be facing the processor with the tendon going away
from them. Tighten the vice so that it holds the bone block
securely but does not crush it.
[0063] 15. Repeat steps 10 and 11 for both plugs.
[0064] 16. When the plugs are completed, remove the excess patella
bone from the vice and detach the vice from the table.
[0065] 17. Remove the cutter from the Jacob's chuck and place a 1.5
mm drill bit into the chuck. Tighten with the chuck key.
[0066] 18. Using a saw, cut each plug to approximately 30 mm in
length (no less than 45 25 mm)
[0067] 19. Using the Arthrex clamp, place the plug into it with the
end of the plug flush with the end of the clamp. Position the plug
in the anterior/posterior position. Using the first guide hole
nearest the flush end of the plug, drill a hole through the plug
with the 1.5 mm drill bit. Turn the plug 180 degrees so that it is
positioned in the medial/lateral position. Use the second guide
hole from the flush end of the plug to drill a second hole through
the plug.
[0068] 20. Repeat step 19 for all bone plugs.
[0069] 21. Using a sizing apparatus insert each bone plug into the
appropriate size gauge. The entire BTB should slide completely
through easily. Trim if necessary.
[0070] 22. Thoroughly lavage bone plugs with sterile water or
saline.
* * * * *