U.S. patent application number 16/903447 was filed with the patent office on 2022-03-03 for system, devices and methods for anatomically correct reconstruction of ligaments.
This patent application is currently assigned to Medacta International SA. The applicant listed for this patent is Medacta International SA. Invention is credited to Christian FINK, Wolfgang SCHWAIGER, Rainer SIEBOLD, Robert SMIGIELSKI.
Application Number | 20220061979 16/903447 |
Document ID | / |
Family ID | |
Filed Date | 2022-03-03 |
United States Patent
Application |
20220061979 |
Kind Code |
A1 |
SMIGIELSKI; Robert ; et
al. |
March 3, 2022 |
SYSTEM, DEVICES AND METHODS FOR ANATOMICALLY CORRECT RECONSTRUCTION
OF LIGAMENTS
Abstract
A method, system and devices for the reconstruction of ribbon
shaped ligaments following the anatomical native insertion sites of
the ligaments in the corresponding bones is described. The
reconstruction of the anterior cruciate ligament of the human knee
is depicted. The system includes means for positioning and creating
bone-tunnels, the preparation of grafts and the fixation thereof.
The devices intended for bone tunnel creation take into account the
ribbon-shaped nature of the ligament and can be adjusted to patient
specific anatomy and take into consideration the various typologies
of the ligament insertion sites. The method and devices for graft
preparation are construed to reflect the anatomy of ligaments under
consideration as close as possible to native ligaments by imitating
the ribbon-like nature of native ligaments. The presented fixation
methods follow this principle and are intended to support the
ribbon-like nature of the grafts and are intended to support
in-growth of the grafts. Furthermore, accessories supporting
preparation of the grafts are presented.
Inventors: |
SMIGIELSKI; Robert;
(Nieporet, PL) ; FINK; Christian; (Innsbruck,
AT) ; SIEBOLD; Rainer; (Walldorf, DE) ;
SCHWAIGER; Wolfgang; (Innsbruck, AT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medacta International SA |
Castel San Pietro |
|
CH |
|
|
Assignee: |
Medacta International SA
Castel San Pietro
CH
|
Appl. No.: |
16/903447 |
Filed: |
June 17, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14769565 |
Oct 5, 2015 |
10799334 |
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PCT/IB2014/000196 |
Feb 24, 2014 |
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16903447 |
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61767816 |
Feb 22, 2013 |
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International
Class: |
A61F 2/08 20060101
A61F002/08; A61B 17/17 20060101 A61B017/17 |
Claims
1.-19. (canceled)
20. A system for creating a graft for ACL reconstruction, the
system comprising a device for making the graft for ACL
reconstruction, the graft comprising a first portion which is
shaped and dimensioned to substantially conform to a slit shaped
bone entrance point, a second portion that is shaped and
dimensioned to be substantially ribbon like, and a third portion
which is shaped and dimensioned to substantially conform to a
half-moon shaped aperture.
21. A method of preparing the graft of claim 20 for a ligament
reconstruction procedure, comprising the steps of: harvesting a
tendon; cleaning the tendon; arranging individual tendon strands in
a substantially ribbon-like, flat manner to mount and fixate the
tendon; and, preparing the individual tendon strands in a linear
arrangement.
22. A method of preparing the graft of claim 20 for a ligament
reconstruction procedure, comprising the steps of: harvesting a
tendon to obtain a round tendon structure; cleaning the round
tendon structure; preparing a substantially flat, ribbon-like
structure from the round tendon structure along a longitudinal axis
of the round tendon structure following tendon fibers, the
substantially flat, ribbon-like structure having a first side and a
second side; spanning the first side of the substantially flat,
ribbon-like structure substantially orthogonally to the
longitudinal axis of the substantially flat, ribbon-like structure
by attaching the substantially flat, ribbon-like to an attachment
structure; and, spanning the second side of the substantially flat,
ribbon-like structure substantially orthogonally to the
longitudinal axis by attaching the substantially flat, ribbon-like
to an
23. A method of preparing the graft of claim 20 for a
reconstruction procedure, comprising the steps of: harvesting a
tendon having a plurality of tendon strands; cleaning the tendon;
providing a split-button device having a lower partition and an
upper partition; introducing the tendon into the lower partition;
introducing the tendon into the upper partition; providing a
fiber-pod having separate fields and loops; laying each tendon
strand in a separate field; weaving the plurality of tendon strands
through the loops with a plurality of pull chords; tightening the
tendon strands by pulling the pull chords; and, optionally securing
the tendon strands with sutures.
24. A method of preparing the graft of claim 20 for a procedure,
comprising the steps of: harvesting a flat, ribbon-like portion of
a tendon (e.g. patella or quadriceps tendon); cleaning the tendon
portion; preparing a substantially flat tendon structure; and,
attaching said structure to fixation means allowing the upholding
of a flat appearance and structure of the graft.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. Ser.
No. 14/769,565, filed on Oct. 5, 2015, which is the National Stage
of International Application No. PCT/IB2014/000196, filed Feb. 24,
2014, which claims benefit under 35 USC .sctn. 119(a), to U.S.
provisional patent application Ser. No. 61/767,816, filed Feb. 22,
2013.
FIELD OF THE INVENTION
[0002] The current invention relates to reconstruction of ribbon
shaped ligaments, in general, and more precisely to new methods,
systems and devices for a more naturally occurring anatomical
reconstruction of the cruciate ligaments. By way of example, the
reconstruction of the anterior cruciate ligament is described.
BACKGROUND OF THE INVENTION
[0003] The reconstruction of ligaments is necessary, when a
ligament is torn and other measures to stabilize the affected joint
do not show sufficient success. Among other joints, the knee is
particularly affected. The anterior cruciate ligament ("ACL")
suffers the most injuries, predominantly among competitive
athletes. ACL reconstruction surgery is one of the most common
types of orthopedic surgeries and approximately 60,000-75,000 ACL
reconstructions are performed annually in the United States, and
many more worldwide.
[0004] Movements of the knee joint are determined by the shape of
the articulating surfaces of the tibia and femur and the
orientation of the four major ligaments of the knee joint: the
anterior cruciate ligament (ACL) and posterior cruciate ligament
(PCL) and the medial and lateral collateral ligaments function as a
four bar linkage biomechanical mechanism. The principal function of
the ACL is to resist anterior displacement of the tibia on the
femur when the knee is flexed and control the "screw home
mechanism" of the tibia in terminal extension of the knee. Knee
flexion/extension involves a combination of rolling and sliding
which is called "femoral roll back." This allows increased ranges
of flexion. Asymmetry between the lateral and medial femoral
condyles permits the lateral condyle to roll a greater distance
than the medial condyle during 20.degree. of knee flexion. This
causes coupled external rotation of the tibia which has been
described as the "screw-home mechanism" of the knee that locks the
knee into extension. The ACL drives this screw home mechanism, and
absence of ACL control is the basis of the pivot shift test of an
ACL deficient knee.
[0005] A secondary function of the ACL is to resist varus rotation
of the tibia, especially in the absence of the collateral
ligaments. Additionally, the ACL resists internal rotation of the
tibia. An ACL tear is most often sports-related, and results in
knee joint instability and impaired biomechanical function.
However, ACL tears also occur during rough play, motor vehicle
collisions, falls, and work-related injuries. A high percentage of
sports-related ACL tears are "non-contact" injuries. The injury
occurs without the contact of another athlete, such as a tackle in
rugby or football, or physical contact between basketball players.
Most often ACL tears occur when an athlete pivots or lands from a
jump. The knee "gives-out" from under the athlete when the ACL is
torn and can no longer serve to biomechanically stabilize the knee.
Furthermore, female athletes are at a higher risk of injuring their
ACL while participating in sporting activities than male
athletes.
[0006] High profile athletes very often have particular difficulty
once they have sustained an ACL tear. Competitive sports, such as
basketball, hockey, soccer, football and rugby require a fully
biomechanically functioning ACL to perform maneuvers such as
cutting, pivoting, and sudden turns. Periodic athletes may be able
to function in their normal daily activities without a normally
biomechanically functioning ACL, but athletes engaging in
high-demand sports have difficulty in doing so. Hence, athletes
with ACL tears are often faced with the decision to undergo ACL
reconstructive surgery in order to return to their previous level
of performance.
DESCRIPTION OF THE RELATED ART
[0007] Anterior cruciate ligament (ACL) reconstructions are
commonly performed by placing one or two bone tunnels at a tibial
and femoral location of the torn ACL. By oblique drilling, oval
bone tunnels at the tibial and femoral locations are created.
(Siebold et al., Restoration of the tibial ACL footprint area and
geometry using the Modified Insertion Site Table, Knee Surg Sports
Traumatol Arthrosc., 2012 September; 20(9):1845-9, the content of
which is incorporated herein by reference). Various methods of ACL
reconstruction have been proposed in the art. By way of example,
U.S. Pat. No. 6,723,524 describes: "A surgical implant for securing
ligament grafts into a joint. The implant is formed entirely of
allograft cortical bone, and has a tapered tip with a suture eye. A
length of suture is knotted or looped through the eye. The suture
is used to draw the implant transversely through a looped graft
construct to fix the graft by spanning a bone socket. The implant
is used for knee ligament repair by forming a longitudinal socket
in a bone. A flexible strand is drawn with the pin through the
bone. A looped portion of the flexible strand is diverted so as to
protrude out of the entrance to the longitudinal socket. The ends
of the flexible strand remain accessible on either side of the
bone. The ligament graft is captured within the strand loop
protruding from the entrance to the socket. The strand is retracted
into the socket, drawing the graft into the socket by pulling on
the accessible ends of the flexible strand."
[0008] Similarly, U.S. Pat. No. 5,374,269 also provides a method
for ACL reconstruction. However, the art has several drawbacks,
since it fails to take into consideration the native ACL insertion
site to the femur and tibia and the shape of the ACL within the
knee joint, and resultant biomechanical functionality within a
single joint and in relation to an un-injured native ACL joint.
Anatomical dissections show, that the ACL, like other ligaments,
resembles more a "ribbon-like structure" rather than an oval
structure. The femoral insertion of the ACL has a longitudinal
(8-18 mm) but narrow shape (3-5 mm). (Smigielski et al., Ribbon
anatomy of anterior cruciate ligament--part 1. Femoral attachment
and midsubstance (submitted for review), the content of which is
incorporated by reference) Therefore, conventional oval bone tunnel
drilling fails to reconstruct the natural anatomical shape of the
native ACL insertion site of the ACL attachment points on the
femur, because in one direction the reconstruction is too narrow
and in the other direction too wide to resemble natural anatomic
conditions and two and three dimensional structure, and provide for
the naturally intended stability and biomechanical function of the
knee joint.
[0009] On the tibial side, anatomical dissections have shown, that
the insertion site of the ligament is not oval but appears rather
"half-moon" or C-shaped. In some patient specific variations, the
C-shaped insertion site is elongated on one end of the C, thereby
having an appearance of a more "J-shaped"insertion site. Siebold et
al, Tibial C-shaped insertion of the Anterior Cruciate Ligament
without Posterolateral Bundle, Chapter of ESSKA Book: Anterior
Cruciate Ligament Reconstruction, DOI) 10.1007/978-3-642-45349_3,
ESSKA 2014, the content of which is hereby incorporated by
reference. For the purposes of this application, the meaning of the
term "C-shaped" includes variations of a C-shape, but with the
insertion site mimicking a native insertion site, in one variant of
the invention.
[0010] As on the femoral side, the conventional bone tunnel
drilling technique does not reflect the native or natural
anatomical situation on the tibial side. The natural anatomical
reconstruction of the tibial insertion is not possible with an oval
bone tunnel. Furthermore, parts of the anterior root of the lateral
meniscus may be damaged by the conventional technique.
[0011] Current methods aim to reconstruct the ligament by
orientating the graft at the general prior location of the ligament
while not considering the natural footprint of the ACL at both
tibial and femoral natural anchor points, while, in contrast, the
method, devices and systems, here focus on the reconstruction of
the insertion site of the ligament in the bone in a manner that
substantially matches or mimics the natural ACL anchor point
footprints on the tibia and the femur to obtain optimal anchor
point configurations and biomechanical knee joint movement. This is
a fundamental distinction that solves a major problem in the art,
since the naturally occurring tibial and femoral ACL anchor
footprint does not necessarily reflect the artificially made
surgical insertion site, and therefore the optimal and natural
biomechanical anchor point of the ligament. The present invention
is further directed to solve this problem in the art, and does so.
This is due to the fact, that--upon rupture of the ACL--not only
the ligament, but also synovial and fat tissue is dislocated from
the bone, giving the perceived footprint of the ligament insertion
site a broader and more distorted appearance than in nature. For
example, as shown by Smigielski et al., the ACL's fibers form a
flat ribbon as close as 2 to 3 mm from its naturally occurring
femoral attachment point, while the respective footprint at this
site falsely appears to be a broader and more cylindrical structure
after ACL rupture.
[0012] In summary, conventional tibial and femoral bone tunnel
drilling tools, systems and methods do not anatomically reconstruct
the naturally occurring insertion sites of the ACL graft at points
on the tibia and femur that reflect the natural anchor point. The
same holds true for ligament reconstruction techniques in other
parts of the body. Hence, there exists a need in the art for tools,
systems and methods suitable for the anatomical reconstruction of
ribbon like ligaments and proper graft dimensioning and shaping in
a ribbon like manner in the interior of the knee joint and other
joints as well as outside of joints that conform to the natural
anchor points of a native ACL on both the femur and the tibia
post-reconstruction. The present invention salves these and other
problems in the art.
SUMMARY OF THE INVENTION
[0013] The invention provides a system for preparing a first and
second bone for a graft procedure. The system includes a device for
creating on the first bone an entrance point mimicking a first
native ligament attachment footprint, the first native ligament
insertion site optionally being a substantially half-moon shaped
footprint. The device has an appliance for sequential drilling
and/or burring of overlapping bores, which are arranged in a
c-shaped manner to create or re-create a substantially c-shaped
insertion site.
[0014] The invention also includes a second device for creating on
the second bone an entrance point mimicking a second native
ligament attachment footprint. The second native ligament
attachment footprint optionally has a substantially slit shaped
footprint, and the device has an appliance for sequential drilling
and/or burring of overlapping bores. The bores are arranged in a
substantially or perfectly slit-shaped manner to create a
slit-shaped insertion site. The slit-shaped insertion site
substantially conforms in size and cross-sectional dimension to a
corresponding aperture created with the first device.
[0015] In another variant, the system includes and the method
includes the use of a third device. The third device is selected
from the group consisting of a device for creating a substantially
ribbon-like ACL graft (in which the graft has a first end and a
second end), a device having an appliance allowing to maintain the
ribbon-like appearance of the graft by affixing parallel tendon
bundles or affixing tendons which are split and prepared in a way
to give a flat, ribbon like appearance, and a device for affixing
portions of a tendon which have been prepared to give a
substantially flat and ribbon like appearance.
[0016] In yet another variant, the system includes and the method
includes the use of a fourth device for fixing at least a portion
of the first end of the graft at a tibial anchor point. The fourth
device has an appliance which allows affixing of a substantially
flat graft to a flat or substantially flat structure on the fourth
device by attaching the graft to the flat structure, the flat
structure being constructed to be flexible enough to pass through a
c-shaped bone tunnel.
[0017] In another variant, the invention provides a graft for ACL
reconstruction. The graft includes a first portion which is shaped
and dimensioned to substantially conform to a slit shaped bone
entrance point. A second portion is shaped and dimensioned to be
substantially ribbon like, and a third portion that is shaped and
dimensioned to substantially conform to a C-shaped bone entrance
point.
[0018] In yet another variant, the system is used for creating a
graft for ACL reconstruction and the system includes a device for
making the graft.
[0019] The system and method is used for reconstructing a portion
of a knee joint with a torn anterior cruciate ligament using a
graft. The graft has a first end and a second end. It is
appreciated that the naturally occurring attachment footprints of a
native ACL are mimicked or reconstructed to provide biomechanical
stability to the knee joint that matches or substantially matches
the biomechanical stability provided by a native ACL. The system
includes a first immobilizer that has a button-like device attached
to a flat structure. The first immobilizer is designed for
positioning and use at a portion of the first end of the graft in,
or optionally on a femur, at least a portion of the graft is
adapted for passing through a substantially slit shaped aperture on
the femur; and a second immobilizer having a flat structure
attached to a mechanism. The mechanism allows for and provides for
immobilization of the attached graft by wedging and blocking of the
attached fixation means, and the second immobilizer is constructed
and used for positioning and use at a portion of the second end of
the graft in, or optionally on a tibia, such that at least a
portion of the graft is adapted to pass through a substantially
C-shaped aperture on the tibia.
[0020] In another variant, the invention provides a method of
reconstructing a knee joint with an anterior cruciate ligament tear
using a graft. The graft has a first end and a second end. The
method includes the steps of: immobilizing a first end of the graft
on a femur, at least a portion of the graft passing through a
substantially slit shaped aperture on the femur, immobilizing a
second end of the graft on a tibia, at least a portion of the graft
passing through a substantially C-shaped aperture on the tibia; and
affixing the ends of the graft on their respective insertion sites
in a manner mimicking naturally occurring attachment insertion
sites of a native ACL, in order to provide biomechanical stability
to the knee joint.
[0021] In another variant, the invention provides a method of
providing substantially equal biomechanical stability for a bipedal
mammal. The bipedal mammal has a native ACL in a first knee joint
and a torn or damaged ACL in a second knee joint in the clinical
setting. The method includes reconstructing the torn ACL in the
second knee joint to obtain a reconstructed ACL. The reconstructed
ACL includes a first portion of a graft passing through a
substantially slit-like aperture in a first bone, and a second
portion of the graft passing through a substantially C-shaped
aperture in a second bone; affixing the ends of the graft on their
respective insertion sites in a manner mimicking naturally
occurring attachment insertion sites of a native ACL, in order to
provide biomechanical stability to the knee joint; and, allowing
for healing with physiotherapy and supervised recovery, whereby
thereafter, the biomechanical stability of the first knee joint is
substantially similar to the biomechanical stability of the second
knee joint.
[0022] The invention further includes a method of providing
substantially equal biomechanical stability for a bipedal mammal
having a native ACL in a first knee joint and torn ACL in a second
knee joint, whereby after healing, the biomechanical stability of
the knee joints are substantially similar, the method comprising
the steps of: forming a graft of an anatomically correct
reconstructed ACL; forming an ACL footprint mimicking a native ACL
footprint in the second knee joint; passing a first portion of the
graft that passes through a substantially slit-like aperture in a
first bone; passing a second portion of the graft through a
substantially C-shaped aperture in a second bone; affixing the ends
of the graft on their respective insertion sites in a manner
mimicking naturally occurring attachment insertion sites of a
native ACL, in order to provide biomechanical stability to the knee
joint; and allowing for healing with physiotherapy and supervised
recovery, whereby thereafter, the biomechanical stability of the
first knee joint is substantially similar to the biomechanical
stability of the second knee joint.
[0023] In yet another aspect, the invention includes a method of
preparing a tibia for an anatomically correct ACL reconstruction.
The method includes cleaning and identifying a tibial native ACL
footprint; measuring the tibial native ACL footprint with a
template; locating and orienting a tibial insertion site;
positioning a tibial aiming device; drilling a bone tunnel, or
optionally a pocket, correlated to the native tibial insertion site
that has been cleaned and identified and being in a substantially
C-shaped configuration; removing the tibial aiming device; and,
optionally cleaning drilling edges.
[0024] In yet further variant, the invention provides a method of
preparing a femur bone for an anatomically correct ACL
reconstruction. The method includes the steps of: cleaning and
identifying a femoral ACL footprint; measuring the native femoral
ACL footprint with a template; locating and orienting a femoral
insertion site; positioning a femoral aiming device; drilling a
bone tunnel, or optionally a pocket, correlated with the native
femoral insertion site in a substantially slit shaped native
configuration; removing the femoral aiming device; and optionally
cleaning drilling edges.
[0025] The invention also provides a method of creating a tibial
bone tunnel during a ligament reconstruction surgery, comprising
the steps of: cleaning and identifying a native tibial footprint;
measuring a native tibial footprint with a template; attaching or
adjusting an intra-articular template to a tibial guiding device;
attaching or adjusting a corresponding drill sleeve to the tibial
guiding device; drilling to provide a guide-wire or a drill which
stabilises the tibial guiding device; orienting the tibial guiding
device; drilling adjacent bores or adjacent k-wires in case where a
drill was set to stabilise the tibial guiding device; removing the
tibial guiding device; drilling a bore over the guide-wire or
adjacent guide wires; and, optionally cleaning drilling edges.
[0026] In yet further variant, the invention provides a method of
creating a femoral bone tunnel, comprising the steps of: cleaning
and identifying a native femoral footprint; measuring a native
femoral footprint with a template; introducing a k-wire with a
stamping device with a corresponding femoral guiding device;
setting the k-wire using an aiming template and an arthroscope;
drilling to provide a guide-wire or a drill which stabilises the
femoral guiding device; orienting the femoral guiding device;
drilling adjacent bores or adjacent k-wires in case where a drill
was set to stabilise the femoral guiding device; removing the
femoral guiding device; drilling to a bore over the guide-wire;
and, optionally cleaning drilling edges.
[0027] In yet another variant, the invention provides a method of
preparing a graft for a ligament reconstruction procedure,
comprising the steps of: harvesting a tendon; cleaning the tendon;
arranging individual tendon strands in a substantially ribbon-like,
flat manner to mount and fixate the tendon; and, preparing the
individual tendon strands in a linear arrangement.
[0028] In yet further aspect, the invention provides a method of
preparing a graft for a ligament reconstruction procedure,
comprising the steps of: harvesting a tendon to obtain a round
tendon structure; cleaning the round tendon structure; preparing a
substantially flat, ribbon-like structure from the round tendon
structure along a longitudinal axis of the round tendon structure
following tendon fibers, the substantially flat, ribbon-like
structure having a first side and a second side; spanning the first
side of the substantially flat, ribbon-like structure substantially
orthogonally to the longitudinal axis of the substantially flat,
ribbon-like structure by attaching the substantially flat,
ribbon-like to an attachment structure; and, spanning the second
side of the substantially flat, ribbon-like structure substantially
orthogonally to the longitudinal axis by attaching the
substantially flat, ribbon-like to an attachment structure.
[0029] In yet further variant, the invention provides a method of
preparing a graft for a reconstruction procedure, comprising the
steps of: harvesting a tendon having a plurality of tendon strands;
cleaning the tendon; providing a split-button device having a lower
partition and an upper partition; introducing the tendon into the
lower partition; introducing the tendon into the upper partition;
providing a fiber-pod having separate fields and loops; laying each
tendon strand in a separate field; weaving the plurality of tendon
strands through the loops with a plurality of pull chords;
tightening the tendon strands by pulling the pull chords; and,
optionally securing the tendon strands with sutures.
[0030] In another embodiment, the invention provides a method of
preparing a graft for a procedure, comprising the steps of:
harvesting a flat, ribbon-like portion of a tendon (e.g. patella or
quadriceps tendon); cleaning the tendon portion; preparing a
substantially flat tendon structure; and attaching said structure
to fixation means allowing the upholding of a flat appearance of
the graft.
[0031] In yet further variant of the method, the invention provides
a method of reconstructing a ligament using a first bone tunnel and
a second bone tunnel, comprising the steps of: creating the first
bone tunnel according to and/or or corresponding to a first native
ligament insertion site; creating a second bone tunnel according to
and/or corresponding to a second native ligament insertion site;
preparing a substantially ribbon-like, flat graft, the graft having
a first end and a second end; pulling in the graft via the first
bone tunnel into the second bone tunnel; fixing a portion of the
first end of the graft in the second bone tunnel; tightening and
fastening the graft; and, fixing a portion of the second end of the
graft in the first bone tunnel. In this variant of the method the
first bone tunnel is a tibial bone tunnel, and the second bone
tunnel is a femoral bone tunnel.
[0032] In another variant, a system, device and method are provided
for the reconstruction of ligaments and more specifically for the
anatomically correct reconstruction of the anterior cruciate
ligament (ACL).
[0033] It is an object of the invention to provide preparation,
positioning and fixation devices for various grafts to create a
ribbon like structure that mimics a native ACL.
[0034] It is another object of the invention to provide methods for
the anatomical reconstruction of ribbon like ligaments, especially
the anterior cruciate ligament, to favour the delay of the onset of
arthrosis in the affected joint, which is a common consequence of
current reconstruction techniques.
[0035] It is another object of the invention to provide tools used
in the system and method for the creation of graft insertion sites
of natural ACL anchor point sites (at the surface of the tibia and
femur), which have a slit-like or substantially slit-like
appearance to reconstruct the ACL in a ribbon-like fashion with
straight and curved insertion sites at the femur and tibia,
respectively, and thus mimic natural biomechanical ACL function and
stability.
[0036] It is yet another object of the invention to create graft
tunnels, which increase and favour bone graft interaction by
providing as much bone-graft interface as reasonably possible,
which again favours nutrition and in-growth of the graft, thereby
reducing the risk of re-rupture of the graft post procedure.
[0037] It is another object of the invention to provide means for
fixing the graft in the tibial and femoral tunnel, which allow
enhanced bone-graft interaction compared to current fixation
methods.
[0038] It is a further object of the invention to provide tools
adjustable to the anatomic conditions of the patient for the
accurate and simple location of the insertion sites.
[0039] It is another object of the invention to provide a tibial
drill guide, which minimizes damage to parts of the anterior root
of the lateral meniscus, as opposed to current drilling methods,
where these structures may be damaged more severely.
[0040] It is another object of the invention to provide a femoral
drill guide, which allows direct visualisation of the femoral
insertion site and avoids damage to the femoral condyle by
supplying a drill-sleeve, which covers the drill as opposed to
current drilling methods, where these structures may be damaged by
drills touching the femoral condyle.
[0041] It is another object of the invention to provide graft
preparation means, which allow a ribbon-like attachment of various
grafts.
[0042] It is yet another object of the invention to split a round
tendon-structure into a ribbon-like structure that mimics a natural
ACL, which resembles more the ribbon-like anatomy than current
graft preparation methods.
[0043] It is another object of the invention to provide graft
preparation and fixation means, which allow the fixation of
split-tendon grafts in the tibial and femoral tunnel.
[0044] It is another object of the invention to provide graft
preparation and fixation means, which allow the fixation of flat
tendon grafts harvested from the patella tendon and the quadriceps
tendon.
[0045] The present invention is directed to devices, systems and
methods that are also further described in the following Brief
Description of the Drawings, the Drawings, the Detailed Description
of the Invention, and the claims. Other features and advantages of
the present invention will become apparent from the following
detailed description of the invention made with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] FIG. 1A is an anatomical depiction of the ligament structure
of the knee.
[0047] FIG. 1B is a side perspective view of the tibial insertion
site of the ACL with the arrows pointing to the insertion site.
[0048] FIG. 1C is a side perspective view of the femoral insertion
site of the ACL with the arrows pointing to the insertion site and
the caliper illustrating the approximate length of the insertion
site.
[0049] FIG. 2A is a perspective view of an assembled tibial aiming
device, in which k-wires are used to stabilize a drill
template.
[0050] FIG. 2B is a perspective view of the tibial aiming device
without tibial drill templates.
[0051] FIG. 2C is a perspective view of tibial drill templates and
guide-wires.
[0052] FIG. 3A is a perspective view of a variation of an assembled
tibial aiming device.
[0053] FIG. 3B is a perspective view of a variation of the tibial
aiming device without tibial drill templates.
[0054] FIG. 3C is a perspective view of a variation of tibial drill
templates.
[0055] FIGS. 4A to 4C are plan views of exemplary bore
configurations with tibial drill-sleeves.
[0056] FIG. 5A is a perspective view of a femoral aiming
device.
[0057] FIG. 5B is a perspective view of a femoral aiming device
with mounted arthroscope.
[0058] FIG. 5C is a perspective view of a femoral aiming device
with mounted arthroscope and aiming aid for placing the
guide-wire.
[0059] FIG. 5D is a perspective view of depth marks of a drill at
the edge of the bore sleeve for measuring the depth of the bores
before and during drilling.
[0060] FIGS. 6A to 6C are plan views of different
bore-configurations with the femoral drill-sleeves.
[0061] FIG. 7A is a perspective view of the device for femoral
tendon attachment and fixation for a quadruple graft.
[0062] FIG. 7B are perspective views of a sling and button for
femoral tendon attachment and fixation with flexible window
partitioning.
[0063] FIG. 7C are perspective views of a sling and button for
femoral tendon attachment and fixation wherein the partitioning is
a bar that can move along the sling or loop.
[0064] FIG. 7D is a perspective view of a sling and button for
femoral tendon attachment and fixation with an inserted quadruple
graft.
[0065] FIG. 8A is a perspective view of a device for tibial tendon
attachment and preparation using a quadruple graft.
[0066] FIG. 8B is a perspective view of the backside of the device
with an empty slit.
[0067] FIG. 8C is a perspective view of the backside of the device
with a slit containing a cord.
[0068] FIG. 8D is a perspective view of the loops of the cord.
[0069] FIG. 8E is a perspective view of the device for tibial
tendon attachment using a quadruple graft, with the tendon in
place.
[0070] FIGS. 8F-8I are progressive views showing tibial tendon
preparation/attachment.
[0071] FIG. 9A to FIG. 9D show four different examples of devices
for extra-osseous fixation of the tendon graft, which is attached
to two cords or sutures; each FIG. 9A to 9D example depicting an
alternate embodiment of the device.
[0072] FIG. 10A is a perspective view for an extra-osseous fixation
device in its open state,
[0073] FIG. 10B shows a perspective view for an extra-osseous
fixation device in its closed state. Upper drawing depicts an
exploded perspective view of the device.
[0074] FIG. 10C is a top view of open (left) versus locked (right)
device.
[0075] FIG. 10D is a cross section of open (left) versus locked
(right) device.
[0076] FIG. 10E is a bottom view of open (left) versus locked
(right) device
[0077] FIG. 11 are perspective views of a device for extra-osseous
fixation of the tendon graft, where the knot of the cords can be
hidden in a countersink in the device.
[0078] FIG. 12A is a perspective view of a device for splitting a
round tendon into a ribbon-like structure.
[0079] FIG. 12B is a detail view of a device FIG. 12A, in which the
round tendon is split by a scalpel as shown.
[0080] FIG. 12C is a perspective view of an alternate embodiment of
a device for splitting a round tendon into a ribbon-like
structure.
[0081] FIG. 13A is a perspective view of the device for femoral
tendon attachment and fixation using a ribbon-like tendon
graft.
[0082] FIG. 13B is a perspective view of bent tape for easier
introduction in the tibial and femoral tunnel.
[0083] FIG. 13C are perspective views of various alternate
embodiments of the element which holds the tendon.
[0084] FIG. 13D are perspective views of various mesh layers bent
over the cord of the embodiments.
[0085] FIG. 14A is a perspective view of an assembled device for
tibial tendon attachment and fixation using a ribbon-like tendon
graft.
[0086] FIG. 14B are perspective views of the fixing device for
tibial tendon fixation using a ribbon-like tendon graft
(extra-osseous element).
[0087] FIG. 14C is a plan view of the element for tendon
attachment.
[0088] FIG. 14D are progressive views depicting the process for
fastening the element for tendon attachment to the fixation
device.
[0089] FIG. 15A is a top view of the femoral aiming aid.
[0090] FIG. 15B is a perspective view of the femoral aiming
aid.
[0091] FIG. 15C is a perspective view of the tip of the femoral
aiming aid.
[0092] FIG. 15D is a perspective view of the femoral aiming aid
aligned with a longitudinal cut of the femur.
[0093] FIG. 16A is a top view of a device for calibrated tensioning
of a graft attached to two cords (device not drawn to scale).
[0094] FIG. 16B is a perspective view (surgeon's view) of a device
for calibrated tensioning of a graft attached to two cords.
[0095] FIGS. 17A and B are flowcharts depicting a generic method
for anatomically correct reconstruction of a ligament structure
employing C-shaped and slit-like bore tunnels.
[0096] FIGS. 18A and B are flowcharts depicting a method for
anatomically correct reconstruction of a ligament structure
employing C-shaped and slit-like bore tunnels.
[0097] FIGS. 19A and B are flowcharts depicting generic methods for
the preparation of flat, ribbon-like grafts from multiple parallel
bundles or from split tendons.
[0098] FIGS. 20A and B are flowcharts depicting the methods for
creating a ribbon-like ACL graft from either multiple parallel
bundles or from a tendon, which is split to form a ribbon-like
structure.
[0099] FIG. 20C is a flowchart depicting the method for inserting,
tensioning and fixing a ribbon-like graft for anatomical ACL
reconstruction
[0100] FIG. 21A is a photograph depicting a ribbon-like graft made
from a multiple tendon bundle.
[0101] FIG. 21B is a photograph depicting a ribbon-like graft made
from a split tendon.
[0102] FIG. 22A is a perspective view of the tibial dilator.
[0103] FIG. 22B is another perspective view of the backside of the
tibial dilator (with inserted k-wires).
[0104] FIG. 22C is a detail of the "head" of the tibial
dilator.
[0105] FIG. 22D is a top view of the "head" of the tibial dilator
with inserted k-wires.
[0106] FIG. 23A is a perspective view of the femoral dilator.
[0107] FIG. 23B is a detail of the "head" of the femoral
dilator.
[0108] FIG. 23C is a detail of the "head" of the femoral dilator
with inserted k-wire.
[0109] FIG. 23D is a top view of the "head" of the femoral
dilator.
[0110] FIG. 24 illustrates an overall system view with exemplary
system devices described herein, and in which a plurality of the
system devices described herein are used in various
combinations.
[0111] Those skilled in the art will appreciate that elements in
the figures are illustrated for simplicity and clarity and have not
necessarily been drawn to scale. For example, dimensions may be
exaggerated relative to other elements to help improve
understanding of the invention and its embodiments. Furthermore,
when the terms `first`, `second`, and the like are used herein,
their use is intended to distinguish between similar elements and
not necessarily for describing a sequential or chronological order.
Moreover, relative terms like `front`, `back`, `top` and `bottom`,
and the like in the figures, Description and/or in the claims are
not necessarily used for describing exclusive relative position.
Those skilled in the art will therefore understand that such terms
may be interchangeable with other terms, and that the embodiments
described herein are capable of operating in other orientations
than those explicitly illustrated or otherwise described.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0112] The following description is not intended to limit the scope
of the invention in any way as it is exemplary in nature, serving
to describe the best mode of the invention known to the inventors
as of the filing date hereof. Consequently, changes may be made in
the arrangement and/or function of any of the elements described in
the exemplary embodiments disclosed herein without departing from
the spirit and scope of the invention.
[0113] In the following description, complete methods, devices and
systems for ligament reconstruction, especially of the anterior
cruciate ligament and its use are described. The systems comprise
aiming devices for creating the tibial and femoral tunnels, devices
for graft preparation and fixation, as well as accessories to
achieve the reconstruction of ligaments that mimic the natural ACL
in biomechanical shape, function and anchoring to the tibia and
femur.
[0114] The method further includes repairing a knee joint with
anterior cruciate ligament damage with a graft. The graft has a
first end and a second end. The method includes immobilizing a
first end of the graft on a femur such that at least a portion of
the graft passes through a substantially slit shaped aperture on
the femur; and, immobilizing the second end of the graft on a tibia
such that at least a portion of the graft passes through a
substantially C-shaped aperture on the tibia. It is appreciated
that the naturally occurring attachment insertion sites of a native
ACL are mimicked to provide biomechanical stability to the knee
joint. It is also appreciated that the method and system provided
herein aim at providing substantially similar naturally occurring
biomechanical stability between the damaged knee joint as compared
to an undamaged knee joint with a native ACL. Moreover, it is
appreciated that the biomechanical stability within the repaired
knee joint is returned to a substantially pre-injury biomechanical
stability, particularly with respect to the ACL interaction between
the posterior cruciate ligaments (PCL). Having substantially
similar biomechanical stability between an uninjured knee joint and
the reconstructed knee joint post ACL reconstruction, and within
the reconstructed knee is highly desirable, especially among
professional athletes.
[0115] As such, a method of preparing for a surgery to provide
substantially equal biomechanical stability for a bipedal mammal is
also included herein. The bipedal mammal (of course, other
quadra-pedal mammals can benefit from the methods and systems of
the invention, in other variants) having a native ACL in a first
knee joint and a torn ACL in a second knee joint. The method
includes providing one or more of the devices described herein to
create an anatomically correct reconstructed ACL in the second knee
joint. The anatomically correct reconstructed ACL includes a first
portion of a graft passing through a substantially slit-like
aperture in a first bone, and a second portion of the graft passing
through a substantially C-shaped aperture in a second bone such
that the biomechanical stability of the first knee joint is
substantially similar to the biomechanical stability of the
un-injured second knee joint.
[0116] With this in mind, a system for preparing a first and second
bone for a graft procedure is also described herein. The system
includes a device for creating on the first bone an entrance point
having a substantially half-moon shaped footprint, and a device for
creating on the second bone an entrance point having a
substantially slit shaped footprint. While it is appreciated that
the method and system herein is described for ACL reconstruction,
it can be used on other ligaments in the body.
[0117] Where the method, device and system of the invention is
applied to damaged ligaments in joints other than the knee joint,
the anatomical attachment sites of the native ligaments are
substantially matched to the reconstructed ligaments with
corresponding apertures and insertion sites created in the
respective bones so that biomechanical functionality is mimicked to
the native ligament, as well as between joints on corresponding
un-damaged limbs.
Anatomy
[0118] Referring to FIG. 1A, the native, natural anatomy of the
ligament structures within the knee is shown, with special focus on
the anterior cruciate ligament (front). In FIG. 1B, the tibial
plateau is shown with the tibial insertion site of the anterior
cruciate ligament (indicated with arrows). Note the curved
(C-shaped) nature of the tibial insertion site 1000 as indicated by
the black arrows. The native C-shaped cross section of the tibial
insertion site 1000 is identified, and created by the devices,
system and method(s) described herein on the tibial plateau or
plane. The tibial insertion site 1000, created by the method(s),
devices(s) and system, has a substantially planar two-dimensional
cross section that is substantially C-shaped as in nature. The
inner walls created by the device(s), method and system of the
tibial insertion site 1000 are substantially smooth so as not to
have rough edges that could damage the new, prosthetic ligament
that will be resident in the aperture formed by the inner walls and
tunnel through the tibia. Referring now to FIG. 1C, the femoral
insertion site 1102 of the anterior cruciate ligament (marked with
arrows 1100) is shown. Note the flat and ribbon-like nature of the
femoral ligament insertion site 1102. Similarly, the inner walls
created by the device(s), method and system of the femoral
insertion site 1000 are substantially smooth so as not to have
rough edges that could damage the new, prosthetic ligament that
will be resident in the aperture formed by the inner walls and
tunnel through the femur. The femoral insertion site 1102, created
by the method(s), devices(s) and system, has a substantially planar
two-dimensional cross section that is substantially slit-shaped as
in nature.
[0119] The system, devices and method presented here are intended
to allow reconstruction of these ligament structures in a manner
that mimics or substantially matches the naturally occurring
anatomical ACL in conformation, shape and anchor point attachment
design as closely as reasonable possible to the natural or native
structures and geometric conformation, e.g. two dimensional
geometric conformation and also three dimensional conformation. As
opposed to current methods, especially the flat and ribbon shaped
nature of the ligament at the insertion sites can be reconstructed
with great ease.
[0120] The system comprises devices (FIGS. 2A-15D, 16A-16-B, 21A-B,
and 22A-22D) and methods (FIGS. 17A-20C) for the creation of the
tibial and femoral insertion sites as well as mounting of the
prosthetic ligaments, both adapted to the individual, specific
anatomy of the patient. It is appreciated that native ligament
footprints vary from patient to patient, and that, in one variant
of the invention, the one or more bone apertures or tunnels created
in the method illustrated (FIG. 20C) are designed to be customized
in size for a respective patient. By way of further example, the
bone apertures or tunnels in the damaged knee are created to match
or substantially match the ligament attachment footprints 1002,
1102 (FIGS. 1B-1C) that are in an un-damaged knee. The bone
apertures or tunnels are created with system 3000 tools 200, 200',
300 (FIGS. 2A-5D), drills (not shown), burrs (not shown),
templates, 4003-4005 (FIGS. 4A-4D), 6004-6006 (FIGS. 6A-6D), and
other accessories described herein.
[0121] The system 3000 (FIG. 24) further includes tools 500 (FIGS.
8A-8I), 550' (FIG. 10A-10E, FIG. 11) 600, 600' (FIGS. 12A-12C) for
the preparation of ribbon-like ligaments from multiple tendon
bundles or from split tendons that also mimic native ligament
structure and function as well as positioning in the damaged joint.
The system 3000 comprises tools (FIGS. 2A-15D, 16A-16-B, 21A-B, and
22A-22D) designed for the preparation and simple fixation of both
kinds of ribbon-like grafts at the tibial and femoral insertion
sites. The use of these devices for the anatomical reconstruction
of the ACL is discussed in detail below. Of course, system 3000
includes other tools that are used to enable the system and method
described herein that are known to surgeons with expertise in
reconstruction procedures.
Device for Creating the Tibial Insertion Site.
[0122] Referring to FIGS. 2A-2C, tibial aiming device 200 is
presented, which allows precise positioning and creation of a
C-shaped tibial tunnel (not shown) by multiple position and
anatomical location drilling techniques and procedures at
footprints 1002, 1102. The fully assembled device 200 is shown in
FIG. 2A, while FIG. 2B depicts the parts, 201-214 which are
preferably made from stainless steel, although other metals can
also be used that are used for surgical tools. FIG. 2C finally
comprises parts 206, 211, 213), which are chosen according to the
anatomy of a patient's insertion site. Device 200 consists of an
intra-articular 201 and an extra-articular part 202, which are
connected via an arc 205 or a similar structure.
[0123] The patient specific, custom sized and dimensioned parts of
FIG. 2C comprise the intra-articular template 206 which fits into
frame 203 of the intra-articular part 201, as well as the
corresponding extra-articular drill sleeve 207 fitting into the
drill-sleeve mounting 214. The intra-articular template 206 can be
chosen according to the anatomy of the insertion site of the
patient. Alternatively, the intra-articular template can be fixed
(permanently or removable) to arc 205 without the use of frame 203
by using other means of fixation (e.g. slits, etc.). By using the
corresponding drill sleeve 207, a drill tunnel is created at
insertion sites, which reproduces the tibial insertion site 1002
according to the principles of the invention.
[0124] Once the tibial plateau (FIG. 1B) has been cleaned from
residuals of the torn ACL (not shown) and the insertion site 1002
has been laid open (FIG. 1B), a tibial intra-articular template 206
can be chosen from a set of different templates according to size
and shape of the insertion site to create the desired substantially
half-moon or fully half-moon footprint on the tibial plateau. In
another variant of the invention, the footprint is a curve or an
arch or a linear slit, as required. As a result, the corresponding
extra-articular drill-sleeve 207 is defined as well. Template and
corresponding drill-sleeve are then introduced into frame 203 of
the intra-articular template mounting 201 and the extra-articular
drill-sleeve mounting 214, respectively. The intra-articular
template 206 is positioned over the tibial plateau in such a way,
that the opening 213 in the template corresponds to the C-shaped
tibial insertion site on the tibial plateau.
[0125] Pin 212 on the intra-articular part 201 and guide wires 211
mounted on drill sleeve 207 of the extra-articular part 202 are
used to fix the tibial aiming device 200 to the tibia. This can be
accomplished by pushing the guide wires towards the tibia, by means
of which pin 212 and guide wires 211 will be indented in the
intra-articular and the extra-articular parts of the tibia,
respectively.
[0126] Therefore guide-wires 211 are introduced in the slotted
holes 210 of the drill-sleeve 207 and thereby slightly compressed
in order to remain fixed unless pushed further in by the surgeon.
They can be moved along these holes until they reach the tibia and
are anchored within. By fastening screw 204 or similar locking
device, the drill-sleeve 207 is compressed and with it the slotted
holes 210. Thereby guide-wires 211 and drill-sleeve 207 are
simultaneously fixed in drill sleeve mounting 214.
[0127] Alternatively, the drill-sleeve itself contains protrusions,
spikes or the like which aid in the fixation of the drill sleeve to
the tibia (not shown).
[0128] In FIGS. 3A to 3C, variation 200' of tibial aiming device
200 (FIGS. 2A-C) is shown. Here, fixing of the aiming device 200'
to the tibia is accomplished by pins 211' (or similar structures),
which are attached directly to the drill sleeve mounting 214. These
pins 211' can be moved longitudinally together with the drill
sleeve mounting, fulfilling the same role as guide-wires 211',
except that they cannot be individually adjusted to the patient
specific geometry of the tibia. As an alternative to fixed guide
wires 211' on drill-sleeve mounting 214, the drill sleeve mounting
itself contains protrusions, spikes or the like which aid in the
fixation of the drill sleeve to the tibia (not shown).
[0129] Guide wire tube 208' (FIG. 3C) allows a guide wire to be
driven to the tibial plateau from outside, after the tibial aiming
device has been fixed to the tibia. Consecutively, a plurality of
bores (in the shown embodiment two) are made by applying drills
through drill tunnels 209' of drill sleeve 207'. The tibial aiming
device can then be removed while the guide-wire, still being kept
in place, is over drilled with a hollow drill. Since the drill
bores overlap (overlapping drill bores), a slit is created, which
corresponds to the intra-articular template 206' and the tibial
insertion site of the ACL, respectively. Cleaning and smoothing of
bore edges can be performed optionally by using a drill, bur, rasp,
chisel, knife or a similar device.
[0130] Alternatively, dilators (not shown), which are of same size
and shape like the intended c-shaped tunnel, can be used to
compress or dislocate remaining bone structures to achieve the
intended smooth surface graft tunnels.
[0131] Referring now to FIGS. 4A-4C, different bore-configurations
4000-4002 (first row) with the corresponding tibial drill-sleeves
4003-4005 (second row) are depicted. As shown in FIG. 4A the
guide-wire 4007 (indicated as a bold circle) can be in the middle
of the two adjacent drill tunnels 4009, 4010. The corresponding
drill sleeve has a guide tube for the guide-wire in the center and
after setting the guide-wire, the drill sleeve can be adjusted by
rotating around the guide wire (depicted in last row, angle
.alpha.). Another bore configuration is shown in FIG. 4B, where the
guiding tube 4013 for the guide-wire (indicated as a bold circle)
is placed off-center and the adjacent drill tunnels overlap. With
this configuration, where the drill tunnels 4011, 4012 are closer
together, smaller and shorter slits can be generated. After setting
the guide-wire, adjustment of the final bores can be made by
tilting the drill-sleeve around the guide-wire (indicated as angle
.beta.). In another configuration (FIG. 4C), the drill sleeve 4005
is fixed by drilling in two guide-wires 4014, 4015 in the lateral
guide-wire tubes, followed by drilling the central bore 4016. After
drilling, the tibial aiming device is removed
[0132] The guide-wires, which are still in place, can then be over
drilled with a hollow drill. No adjustment of the drill sleeve is
possible after setting of the guide-wires here.
[0133] Since the guide wire(s) should not be removed before
over-drilling, the device is designed in a way, that drill-sleeve
207 and drill sleeve mounting 214 can be detached from frame 203
without dislodging the set k-wire (s). In the shown embodiment,
this is accomplished by a design, where drill sleeve mounting 214
and drill sleeve 207 are unlocked from frame 203 and pulled from
the guide-wires.
[0134] Alternatively, employing the configuration in FIG. 4C, the
tibial drill sleeve 4005 can be fixed to the tibia by drilling via
the central bore channel 4016 and leaving the drill in the drill
hole. The drill stabilizes the drill sleeve 4005 and consecutively
(here, by way of example 2) k-wires are drilled through the
adjacent k-wire channels. After removing drill sleeve 4005 and
drill (not shown), the k-wires are over-drilled, resulting in
overlapping bore channels. Of course, it is appreciated that a
plurality of k-wire channels and bore channels can be used in
various embodiments of the invention, positioned in relation to one
another so as to obtain the desired conformation of a respective
insertion site.
Device for Creating the Femoral Insertion Site
[0135] In FIGS. 5A-5D, femoral aiming device 300 is presented,
which aids in precise positioning and creation of the femoral
tunnel resembling the femoral insertion site 1100, which is slit
shaped or substantially slit shaped. As shown in FIG. 1C, the
femoral insertion site 1102 is a straight slit or substantially
straight slit with individual patient specific variations in width
and length, e.g. two dimensional cross section. It is appreciated
that the insertion sites described herein, create a patient
specific, naturally occurring insertion site for the reconstructed
ACL.
[0136] As depicted in FIG. 5A, femoral aiming device 300 consists
of handle 301 attached to guiding sleeve 302 with guiding tube 303
for guide wire 305 and adjacent channels 304 for the drill(s). In
the present embodiment guiding sleeve 302 contains two drill
channels 304. Femoral aiming device 300 may, however, contain just
one or more than two drill channels 304, e.g. a plurality of drill
tunnels. As shown in FIG. 5B, the femoral aiming device 300 can be
equipped with an optional arthroscope 307 to enable direct
visualization of the femoral insertion site 1100 and interior of
the knee joint. Arthroscope 307 can for example be introduced
through a drill channel 304 or any other port (not shown) located
nearby. In another embodiment (FIG. 5A and FIG. 5C) guiding tube
302 has openings 312 at the side walls of the tip of the guiding
tube, which allow lateral vision of the surgeon to the femoral
insertion site 1100.
[0137] As exemplified in FIG. 5C the femoral aiming device 300 can
be further equipped with a guide wire 305, holding "stamping"
device 306 on its distal end. This stamping device is used to allow
a first fixation of the guide wire to the femoral insertion site
1100 by pushing the guide wire into the intra-articular cortex of
the femur.
[0138] The assembled femoral aiming device (as shown in FIG. 5C) is
introduced laterally under direct visualisation employing the
arthroscope 307. By using an appropriate arthroscope 307, the guide
wire and the femoral insertion site 1100 can both be visualized
simultaneously. Positioning of guide wire 305 is furthermore
facilitated by guiding device 900 depicted in FIGS. 15A-15D. Once
the guide wire is placed in the center of the insertion site, it is
fixed by tapping or pushing the "stamping" device 306.
Subsequently, stamping device 306 and arthroscope 307 are removed
and the guide wire is drilled to the posterior cortex of the femur.
Bores (two in the shown embodiment comprising two drill channels or
more bores involving a plurality of drill tunnels, although a
larger number of bores than two are also contemplated in other
variants of the invention) are made by drill 310 guided by drill
channels 304 adjacent to the channel holding the guide wire. The
depth of the bores can be controlled by reading the depth marks 311
on drill 310 before and during drilling (as detailed in FIG. 5D).
As such is it appreciated that the devices, system 3000, and
methods described herein provide for variable depth bore holes and
limit stops on the devices to control the depth of the drilling.
With the help of these depth marks 311, the device 300 can be used
to perform drilling through the whole bone to form a uniform
tunnel, or it can just be used to create a pocket in the bone or
the respective femoral footprints described herein.
[0139] After drilling the bores adjacent to the guide wire, the
femoral aiming device 300 is removed. The guide-wire, which is
still in place, can then be over drilled with a cannulated drill.
Since the drill bores overlap, a slit is created, which corresponds
to the femoral insertion site 1100 of the ACL (as depicted in FIG.
1C). Cleaning and smoothing of the bore edges can be performed
optionally by using a drill, bur, rasp, chisel, knife or a similar
device. Alternatively, dilators, which are of same size,
dimensional conformation, e.g. 2 dimensional or 3 dimensional, and
shape as the intended femoral tunnel, can be used to compress or
dislocate remaining bone structures to achieve the intended graft
channels (refer to FIG. 23A to 23D).
[0140] In FIGS. 6A-6C, different bore-configurations 6000-6002
(first row) with the according femoral drill-sleeves 6004-6006
(second row) are depicted. As shown in FIG. 6A, the guide-wire 6007
(indicated as bold circle) can be in the middle of the two adjacent
drill tunnels 6008, 6009. The corresponding drill sleeve has a
guide tube 6010 for the guide-wire in the center and after setting
the guide-wire, the drill sleeve can be adjusted by rotating around
the guide-wire (depicted in last row, angle .alpha.). Another bore
configuration is shown in FIG. 6B, where the guiding tube for the
guide-wire (indicated as bold circle) is placed off-center and the
adjacent drill tunnels 6012, 6013 overlap. With this configuration,
where the drill tunnels 6012, 6013 are closer together, shorter
slits can be generated. After setting the guide-wire, adjustment of
the final bores can be made by tilting the drill-sleeve around the
guide-wire (indicated as angle .beta.).
[0141] In another configuration (FIG. 6C), the drill sleeve is
fixed by drilling in two guide-wires in the lateral guide-wire
tubes, followed by drilling the central bore. After drilling, the
femoral aiming device is removed. The guide-wires, which are still
in place, can then be over drilled with a hollow drill. No
adjustment of the drill sleeve is possible after setting of the
guide-wires here. Alternatively, employing configuration 6C, the
femoral drill sleeve can be fixed to the tibia by drilling via the
central bore channel 6014 and leaving the drill in the drill hole.
The drill stabilizes the drill sleeve and consecutively (here 2)
k-wires are drilled through the adjacent k-wire channels 6015,
6016. After removing drill sleeve and drill, k-wires are
over-drilled, resulting in overlapping bore channels
Devices for Graft Preparation and Fixation Using Multiple Tendon
Bundles
[0142] The devices 400, discussed in the following two sections
allow for the preparation and fixation of a tendon graft using
multiple tendon bundles. These bundles are aligned in a linear
manner to resemble the ribbon-like nature of the ligament. As an
example, the preparation and fixation of a quadruple graft will be
shown.
[0143] 1) Device for Graft Preparation and Fixation at the Femoral
Side of the Multi-Bundle Graft
[0144] In FIG. 7A, device 400 for femoral tendon attachment and
fixation using a quadruple graft is depicted. The device 400 is
button-like with elongated body 407, holding sling or loop 401,
which is subdivided by at least one partitioning. The fixation of
the sling or loop 401 to the elongated body 407 may be accomplished
either by passing loop 408, 428 through holes in the elongated body
or by fixing the ends of loop- or sling-structure 401 to the
elongated body by other means (see detail 411, 421). The
partitioning can either be a flexible structure 405 or a bar-like
element 425. This partitioning results in at least two "windows"
402, 404, through which the tendon graft is introduced. The
partitioning 405 can be either fixed (FIG. 7A, B) or may move along
sling or loop 401, as exemplified by bar 425 in FIG. 7C.
[0145] The elongated body has furthermore two openings 403, 406
through which pulling cord 409 and a tilting cord 410 can be
introduced. Once the tendon (not shown) is attached to the loop or
sling structure 401, the elongated body 407 of the button-like
device 400 can be pulled through a bone tunnel, until it exits at
the extra-osseous side of the bone. By pulling at the tilting cord,
the button flips into a position perpendicular to the bore and is
thus secured at the extra-osseous side of the bone. A more detailed
description of the mode of action may be found in U.S. Pat. No.
5,306,301 to Graf, the entire disclosure of which is hereby
incorporated by reference. In contrast to the device presented by
Graf et al. in U.S. Pat. No. 5,306,301, device 400 features rigid
or flexible partitioning of the loop or sling structure.
[0146] In FIG. 7D, a first tendon bundle 421 introduced in lower
window 404 and a second bundle 420 in higher window 402 remains
separated by partitioning 405, 425. Pushing together of the
individual tendon strands is thus avoided by the partitioning.
Consecutively, the strands of the tendons form a linear alignment,
where the lower strand of the tendon holds the upper strand apart.
This method allows a ribbon-like arrangement of the individual
tendon bundles. They can still be bent in the transverse direction,
which is especially important, when the graft has to be passed
through a curved (e.g. C-shaped) tunnel.
[0147] Furthermore, pushing together of the individual bundles is
hindered by the sequential entry of higher 420 and lower 421 tendon
strands into the tibial and femoral tunnel. This sequential entry
furthermore eases the pulling in of the tendon. This is especially
important for cases in which narrow, slit-like tunnels are
employed.
[0148] 2) Device for Graft Preparation at the Tibial Side of the
Multi-Bundle Graft
[0149] In FIG. 8A, a device 500 for tibial tendon attachment and
preparation using a multi-bundle graft is depicted. Exemplary the
attachment and preparation of a quadruple graft is shown. The
device 500 consists of base plate 504 with holes 505, which are
connected by slits 506. The size of holes 505 is sufficiently large
to let cord or suture material 501, 502 pass through. Slits 506
are, however, narrower and allow passing of cord 501, 502 only when
it is under a sufficient tensile force, such that the slits are
somewhat widened when pulled there through. FIG. 8B details the
backside of base plate 504 with holes 505 and slits 506 but without
the cord. As depicted, the slit is wider on the backside of base
plate 504 which is thin enough to allow the cord to pass when it is
subject to a sufficiently high tensile force.
[0150] FIG. 8C shows the backside of base plate 504 in the presence
of cord 501, 502. On the backside the slit is somewhat wider than
on the front, forming channels 507 wide enough to accept the cord.
The cord is thus held in channels 507 but cannot pass slits 506
unless subject to a sufficiently high tensile force. Referring now
to FIG. 8D, a detailed view of base plate 504 in the presence of
the cord is shown. The cord is introduced in the following
sequence. Coming from the upper side of the base plate its left
pulling end 501 is fed through hole1. The cord segment between
holes 1 and 2 lies in channel 507 on the backside of the base
plate. The cord is fed through hole 2 to the front side of the base
plate and then back again through hole 3 thus forming loop 503. The
segment between holes 3 and 4 lies again in channel 507 on the
backside of the base plate, and so on. With this procedure, a
structure is created, where pulling ends 501, 502 of the cord as
well as loops 503 are on the front side of the base plate, while
the connecting sections of the cord are on the backside of the base
plate.
[0151] The illustration of FIG. 8A shows an embodiment with 3 loops
503 for the preparation of 4 individual (tendon-) bundles. Other
embodiments of the invention comprise a plurality of bundles, e.g.
greater or lesser numbers of bundles with a correspondingly varying
number of loops 503. Referring now to the sequence of FIGS. 8E to
8I, the formation of a ribbon-like tendon is shown by making use of
base plate 504 with cord 501, 502 arranged in loops 503. In a first
step, the four strands of the tendon are arranged in the manner
shown in FIG. 8E, in which every strand is separated by a loop. In
a second step detailed in FIG. 8F, the left pulling end 501 of the
cord is folded over and fed above the tendon through loops 503 to
the right side. Meanwhile, the right pulling end 502 is passed in
the opposite direction over the tendon through the loops to the
left side. By pulling ends 501 and 502 of the cord, the loops are
pulled towards the base plate and the tendon (FIG. 8G). By further
pulling, the tendon is compressed and thereby fixed (FIG. 8H).
Finally, under the application of a sufficiently high tensile
force, the cord slips through slits 506 of the base plate and the
linear tendon/cord construct is released from the same (FIG. 8I).
The resulting structure can be further secured by "weaving" the
ends of the pulling cords above and under the individual strands of
the tendon or by stitching the pulling cords through the tendon
from the left to the right side and vice versa.
[0152] With this procedure, a linear mounting for the tibial side
of a multi-bundle graft is formed, where the individual strands are
pressed together, but cannot slip over each other, thereby avoiding
a bulky graft to form. This is especially important in the case
where slit-like tunnels with a small width are employed. Another
advantage over other graft preparation methods is, that the bone
tendon interface is as big as possible and that the prepared graft
can be bent, which is especially important, when bone tunnels with
bent (e.g. C-Shaped) cross sections are used for graft
insertion.
[0153] 3) Device 1 for Tibial Fixation of the Multi-Bundle
Graft
[0154] The prepared tendon graft has to be secured at the exit of
the tibial tunnel. This cart be achieved by an extra-osseous
element[[s]] 510', 520', 530' and/or 540', which fixes the cords
coming from the graft. Usually two cords are used, which can but
need not be identical to pulling ends 501, 502, but the devices
shown below can also be adapted to usage of more cords. Referring
now to FIGS. 9A-9D, a series of embodiments of a device 510', 520',
530' and/or 540' for extra-osseous fixation of the tendon graft is
shown. The graft is attached to two (or more) cords or sutures.
Referring now to FIG. 9A, device 510' has a flat rigid body 550,
which is bigger or larger than the created bone tunnels and has two
openings 551, 552 to accept the cords attached to the graft. The
cords are passed through openings 551, 552 and the graft can be
fixed by tying the cords in a knot. Referring now to FIG. 9B,
device 520' has depression 563 in flat rigid body 560. Depression
563 has the purpose of accepting the knot tied between the cords
fed through openings 561, 562. The protrusion of the knot into the
soft tissue surrounding the bone is therefore minimized. Referring
now to FIG. 9C, device 530' has non-circular openings 571, 572 with
narrow regions 573, 574 facing the center of the device. This
results in wedging of the cords before the knot is tied, preventing
loosening of the tension applied to the graft during tying of the
knot.
[0155] In FIG. 9D, device 540' has flat rigid body 580 featuring
sloped extension 585 at the far side of the graft. Furthermore,
body 580 with its sloped extension 585 features two slits 586,
through which the cords are fed. Then the cords are secured by
making knots on each individual cord at position 587 close to the
rise of sloped extension 585. The knots are made large enough in
order not to pass slits 586. After knotting, the cords can be
further tensioned by pulling them over the slope of sloped
extension 585 to securing position 584 more distant from the
graft.
[0156] 4) Device 2 for Tibial Fixation of the Multi-Bundle
Graft
[0157] Referring now to FIGS. 10A-10E, device 550' fixes the two
cords coming from the graft by wedging them between an inner
turning member and its corresponding casing. Base plate 523 is
large enough to bridge the bores of the tunnel. It holds the
casing/sleeve 522 for central fastening member 519, which can be
rotated around its central axis. Furthermore, the device features
two openings 528, 529, shared by sleeve 522 and fastening member
519. Openings 528, 529 allow feeding of the two cords from the
intra-osseous side 521 to the extra-osseous side 520 in its open or
unlocked position. By turning fastening member 519 the cords can be
locked by wedging them between sleeve 522 and the fastening member
as will now be explained in greater detail.
[0158] In FIG. 10A, a perspective view of the device is shown in
its open state in which the cords can pass through openings 528,
529. In FIG. 10B; a perspective view of the device in its closed
state is shown (below). The upper drawing of FIG. 10B depicts an
exploded perspective view of the device. The body of fastening
member 519 has a jagged appearance 537 resembling the threads of a
screw with cut outs 534 of preferably half-cylindrical shape,
corresponding to openings 528, 529. The cords are fixed by turning
inner fastening member 519 relative to outer sleeve 522. Rotation
of the inner fastening member results in displacing its cut outs
from the openings in the sleeve, whereby the cords are compressed
between the jagged inner fastening member and wall 533 of sleeve
522. Preferably, the angle of rotation is chosen in a way to align
the extra-osseous side 520 of the cords with grooves 525 on
fastening member 519. As shown below (FIG. 11), this facilitates
minimal protrusion of the knotted cords into the surrounding tissue
and avoids the unintentional unlocking of the device.
[0159] For clarity, a top view of the device is shown in its open
(left) and closed state (right) in FIG. 10C. As can be seen, the
cut outs of inner turning member 534 are dislocated from openings
528 529 by turning, thereby wedging the cords 520 between turning
member and its corresponding casing.
[0160] In FIG. 10D, a cross section of the device in its open
(left) and closed (right) state is shown. As evident, cords 520 can
pass freely in the open state, while they get blocked by inner
turning member 519, (which has a jagged appearance 537 in this
variant of the device) upon locking of the device.
[0161] In one variant, inner fastening member 519 is a screw which
facilitates its introduction into sleeve 522 during assembly. Other
designs, e.g. cylindrical structures with jagged outer surfaces are
possible as well, as long as the cords get locked upon dislocation
of the corresponding cut outs. Moreover, the jagged appearance of
the surfaces of the inner fastening member and the sleeve are
exemplary only. Rounded structures may serve as well in locking the
cords by wedging. Cut outs 534 corresponding to the sections of
openings 528, 529 on inner fastening member 519 may be of a shape
that the initial turning of the inner turning member is
facilitated. FIG. 10E is a bottom view of the device, illustrating
open (left) and closed state (right).
[0162] In FIG. 11, device 550' is shown with inserted and knotted
cords 520. Grooves 525, along with central depression 524 in
fastening member 519 assure minimal protrusion of knot 538 into the
surrounding tissue region in a way similar to device 520'.
Devices for Graft Preparation and Fixation Using the Split Tendon
Technique
[0163] In the following two sections, devices 600, 600' for the
preparation and fixation of grafts are described, which reconstruct
the ribbon-like nature of the ligament using the split tendon
technique. As an example, the application to the anterior cruciate
ligament is again shown.
[0164] In contrast to the ligament it should replace, the harvested
tendon, which is currently used for reconstruction has a round
cross section. In order to create a flat, ribbon-like structure,
the cylindrical tendon needs to be incised along its length,
preferably to a depth on the order of half its diameter.
Subsequently, the tendon can be unfolded along the cut, whereby the
desired ribbon-like morphology is produced. The incision can be
accomplished by a knife, a sharp spoon or any similar tool.
Longitudinal cutting of the tendon, with minimal destruction of the
parallel tendon fibres, is essential since this could negatively
influence the stability of the graft. Furthermore, the device
should have means to avoid completely cutting or splitting of the
tendon, since this could again negatively influence stability of
the graft. The devices presented below exemplify the creation and
use of ribbon-like structure from single harvested tendons and are
only examples of devices that are used.
[0165] 1) Device for Tendon Splitting
[0166] In FIG. 12A-12C, device 600 is presented, which allows the
preparation of a flat graft from a cylindrical graft. As
exemplified in FIG. 12A, device 600 has base plate 601 with
elevated region 615 over which slider 604 with attached cutting
unit 606 can be moved longitudinally in the direction of arrow 611.
Cylindrical tendon 608 is placed in groove 602 of elevated region
615 and fixed distally with yoke 607 crossing elevated region 615.
Yoke 607 itself may for instance be fixed at the sides 616 of
elevated region 615 for example by screws 603. Cutting unit 606
cuts the cylindrical tendon longitudinally when slider 604 is moved
along the base plate. The position of yoke 607 can be adjusted to
the length of the graft (see arrow 610).
[0167] The incision can be accomplished by using a knife, sharp
spoon or anything the like. A detail of cylindrical graft 608 and
cutting unit 606 is shown in FIG. 12B. Preferably, cutting of the
tendon is performed with a single use surgical blade 606, which can
be attached via a standardized surgical blade adaptor 605.
Longitudinal cutting of the tendon with minimal destruction of the
parallel tendon fibres is essential since this could negatively
influence the stability of the graft. Furthermore, measuring
portions of the device avoid complete cutting of the tendon, by
providing a stable offset of the cutting device from the base
plate.
[0168] In another embodiment, exemplified in FIG. 12C, graft 608 is
moved in its longitudinal direction through device 600' with
stationary cutting unit 606. As shown, cylindrical graft 608 slides
inside bore 614 in structure 612 which is rigidly connected to
mounting 605, 613 of cutting unit 606. Cutting unit 606 is
positioned in a way to allow longitudinal cutting of cylindrical
tendon 608 approximately down to its axis 609. The cutting of the
tendon can be performed with a single use surgical blade 606, which
can be attached via a standardized surgical blade adaptor 605.
[0169] 2) Device for Femoral Fixation of Split Tendon Grafts
[0170] Referring now to FIG. 13A a detailed view of device 700 for
femoral tendon attachment and fixation using a ribbon-like tendon
graft is presented. The device is a button-like device with
elongated body 704 holding tape 703. Tape 703 contains elongated
window 702. Adjacent to window 702 is tape area 701, which is
utilized for sewing the ribbon-like graft to the tape. Furthermore
elongated body 704 has two openings 705, 706, through which a
pulling cord and a tilting cord can be introduced, similar to the
way described in FIG. 7A. Once the tendon is attached to the tape,
elongated body 704 of the button-like device can be pulled through
the bone tunnel, until it exits at the extra-osseous side of the
bone. By pulling on the tilting cord, the button flips into a
direction perpendicular to the bore, thereby being secured at the
extra-osseous side of the bone. A more detailed description of the
mode of action may be found in U.S. Pat. No. 5,306,301 to Graf, the
entire enclosure of which is hereby incorporated by reference. In
contrast to the device presented by Graf et al. in U.S. Pat. No.
5,306,301, the device presented here features a slim tape structure
to avoid bulking of the tendon, when the construct is pulled
through the femoral and tibial tunnel. Furthermore, it features
stitching area 701, used for the fixation of the flat tendon in a
planar way across its entire width spanning the length of window
702. With this proceeding, a semi-rigid structure is formed, where
the tendon graft cannot slip together, while bending in the
transverse direction is still possible as shown in FIG. 13B. The
possibility of tape area 701 to bend is important, since the tape
has first to pass the C-shaped tibial channel before being drawn
into the femoral channel.
[0171] The tape-structure of device 700 depicted in FIGS. 13A-13B
is exemplary only. Other embodiments of the device may employ a
stitching area attached to a loop or a sling. Further variations of
loop or tape structures, which allow a ribbon like attachment of
the tendon to the fixation device, are shown in FIG. 13C.
[0172] In FIG. 13C (embodiments a.) to d.)), the element holding
the tendon is a tape-like structure with window 702 and adjacent
stitching area 701 as described above. Appliances linking this
structure to elongated body 704 may be tape-like 703 or round
structures 709, for example cords. Referring now to FIG. 13C,
embodiment e.) and f.), the element holding the tendon is a
structure, where the area 710 over which the tendon is placed is
thickened by additional strands of material to stiffen said area
and/or provide a stitching area as described above. Appliances
linking structure 710 to elongated body 704 may be round
structures, for example cords, with one 713 or two legs 712.
[0173] In FIG. 13C, embodiments g.) and h.), the area over which
the tendon is placed is stiffened by tube 711, which is preferably
semi-rigid to allow an easy pulling-in of the structure through the
tibial and femoral tunnel. Appliances linking this area to
elongated body 704 may be round structures, for example cords, with
one 713 or two legs 712.
[0174] Alternatively, the stitching area is a flag-like structure
755, which is attached to and can move on a cord 750. Preferably,
this structure is made of a textile or a mesh, which has openings
at the side or in its corners, that allows the passing of a
suture/cord (FIG. 13C, i.).
[0175] Also, a mesh can be bent over the suture and fixed by
stitching or molding the bent mesh in a matrix (e.g. silicone, FIG.
13D, embodiments b.), c.)), whereby the cord protrudes at each side
of the flag (at position 754). In FIG. 13D, embodiment b.), a mesh
751, which is bent over the cord 750 is shown. In FIG. 13D,
embodiment c.), the mesh is moulded in a matrix 753, which allows a
precise modulation of the stiffness of the flag structure by
employing different matrices.
[0176] 3) Device for Tibial Fixation of Split Tendon Grafts
[0177] Referring now to FIG. 14A, assembled device 800 for tibial
tendon attachment and fixation using a ribbon-like tendon graft is
presented. Analogous to the femoral attachment device, the device
800 features tape 801 with window 802 and stitching area 803.
Fixing device 804 has the purpose of fixing the tape at the exit of
the tibial tunnel. It comprises slit 808 designed to let tape 801
pass through. This fixing device has an upper and a lower surface
and slit 808 is inclined to these surfaces (see last drawing of
FIG. 14B). The tape 801 therefore passes through fixing device 804
at an angle. Referring now to FIG. 14B the extra-osseous element of
fixing device 804 for tibial tendon fixation using a ribbon-like
tendon graft is depicted in more detail. The first drawing shows
the device from above, with inclined slit 808 and two adjacent
slits 807, 809 which are open on one side. The openings can be on
the same or on opposing sides (as depicted) of device 804. The
second drawing shows the device 800 from below. Note that opening
810 of slit 808 is shifted with respect to that on the upper side.
This is due to the inclination of the slit, visible in greater
detail in the last drawing of FIG. 14B, where tape and fixing
device are both shown. FIG. 14C shows a preferred embodiment of
tape structure 801. Other variations, such as a tape with constant
width, can be used as well. FIG. 14C shows the preferred embodiment
of said tape structure (801), but also variations as described
under FIG. 13C can be used with this system.
[0178] Referring now to FIG. 14D, a series of images depict the
process of fastening tendon attachment 801 to fixing device 804. In
a first step, the tape is pulled to straighten the graft. By
pushing down the extra-osseous element (fixing device 804) to the
bone adjacent to the tibial tunnel, tape and the extra-osseous
element become wedged (due to the inclination of the slit). This
leads to a first fastening of the tape, which can be further
enhanced by pulling on the tape. In order to secure the tape
further, the tape is strapped through first adjacent slit 807 and
then through second slit 809, Step 2. With this procedure, the tape
can be easily adjusted and secured without the use of a knot.
Application of knots on cords or tapes (or similar structures)
under tension is difficult and in general leads to a loosening of
the tension, which is avoided with this procedure.
[0179] In general, the flat prepared tendon structure can also
secured on the tibial side to device (s) exemplified in FIG. 13C
(embodiments c-h) or FIG. 13D, where cords protrude from the
various graft fixation means. In this case, fixation can be
achieved by extra-osseous elements 510', 520', 530', 540' and/or
550', which fixes the cords coming from the graft and have been
described in more detail in the section describing the tibial
fixation of a multi bundle graft. In a preferred embodiment, the
tibial side of a graft prepared from a split tendon is secured by
device shown in FIG. 13D, embodiment c) and fixed to the tibia by
employing device 550'.
Accessories
[0180] In the following description, accessories aiding in the
correct placement of the femoral tunnel and a device intended to
allow standard tensioning of the graft during reconstruction
surgery are presented.
[0181] 1) Femoral Aiming Aid
[0182] Referring now to FIG. 15A-15D, femoral aiming aid device 900
helps in setting the femoral guide-wire. FIG. 15A is a top view,
while FIG. 15B is a perspective view. The device 900 is positioned
at the lateral intercondylar notch wall at the femoral insertion
site of the ACL with the help of two "noses" 901, 902 at its end.
The device consists of a handle 906 with a curved connecting piece
904, 905 and a tip portion detailed in FIG. 15C. The curvature of
connecting piece 904, 905 allows an easier introduction through an
anterolateral arthroscopy portal. At its tip device 900 has opening
907 for setting a guide wire. Additionally, two noses 901, 902 aid
in placing the device at the right position of the femur, as
depicted in FIG. 15D, where a longitudinal cut through the femur
908 with device 900 in place is shown. One "nose" 902 is aligned
with the posterior aspect of the femoral condyle (see arrow 910,
FIG. 15D) and the second one 901 with the posterior lateral cortex
of the femur (see arrow 911, FIG. 15D). These two "noses" are
designed to position the drill guide at the femoral insertion site.
There is one drill guide for the right and left knee. There are
also different sizes of drill guides to take into account the
different sizes of the individual insertion sites.
[0183] 2) Graft Tensioning Device
[0184] Referring now to FIGS. 16A-16B, device 10000 allows
calibrated tensioning of a graft attached to two cords. Currently,
the tension applied to grafts used for ACL reconstruction is not
standardized and hence subject to high surgeon-specific variation.
Furthermore, studies (Biomechanics and anterior cruciate ligament
reconstruction, Woo S L et al., J Orthop Surg Res. 2006 Sep. 25;
1:2, the content of which is incorporated herein by reference) have
shown, that the tension within the ACL varies in the various fiber
bundles. A standardized procedure, where the graft can be tensioned
taking into account the necessary tension and the distribution of
the tension within the graft overcomes these problems.
[0185] FIG. 16A shows a front view of device 10000 with attached
graft 1050 and graft fixation device 1035. FIG. 16A refers
exemplarily to the graft fixation device of FIGS. 10A and 11. Graft
tensioning device 10000 is, however, applicable to any graft
fixation device in which two cords are employed. As depicted, cords
1040, 1045, coming from the two edges of graft 1050, are fed
through graft fixation device 1035 and attached to suspension 1020
on force sensing device 1015 measuring the force applied to the
cords and transmitted to the graft. Here force sensing device 1015
is depicted as a spring balance, but every appliance serving the
same function can be used. A force sensing device 1015 is attached
to each one of the two cords coming from the graft. Different
tensions can be applied to each cord by tilting handle 1005 to
which the force sensing devices are attached. When a stronger force
is applied to the cord on the left (shown as longer arrow 1060) and
a weaker force (shown as shorter arrow 1055) on that on the right
by tilting the handle, the left and right part of graft 1050 are
subject to a differential force. It should be noted that the use of
a handle facilitates one-handed operation of the device. By
securing the individual cords by the mechanism described in FIGS.
10A to 10E and 11, the tension applied to the graft is locked.
Naturally, devices adapted to the use of a different number of
cords or tapes and corresponding force sensing devices are
variations of device 10000.
[0186] Referring now to FIG. 16B, a perspective view (surgeon's
view) of the device 10000 is shown. As described above, the
differential and calibrated tensioning of the graft can be applied
in a one-handed manner, leaving the other hand free for the
actuation of the locking mechanism of the graft fixation
device.
[0187] 3) Tibial Dilator
[0188] Referring now to FIGS. 22A-22D, a perspective view of the
tibial dilator 1200 is shown. The dilators 1200, which are of same
size and shape as the intended c-shaped tunnel, can be used to
compress or dislocate remaining bone structures to achieve the
intended graft channels. Therefore, the head 1201 is introduced in
the tibial bores with the help of k-wires 1206. The k-wires 1206
are introduced via holes 1213 (FIG. 22C) in the head and in handle
1203 of the dilator. The k-wires can move freely in head and groves
1207 on the backside of handle 1203 (FIG. 22B) In a first position,
the k wires protrude approximately 3-6 cm over the head of the
dilator and the k-wires guide the head through the tibial bores
upon introduction of the device until k-wires reach the end of the
tibial bores. Upon tapping on the back of the dilator 1208, the
dilator moves along k-wires 1206, which hinder a tilting of the
head of the dilator and guide the head through the bores. This is
facilitated by slopings 1209 and 1210, which allow a gradual
compression of the bores until the desired profile 1211 (tibial
channel) at its full extent is reached (FIG. 22D).
[0189] Consecutively, the dilator is removed from the tibial
channel by pulling and tapping on protrusions 1204. This procedure
is facilitated by slopings 1212 and 1214, which hinder that the
head of the dilator gets stuck upon removal.
[0190] 4) Femoral Dilator
[0191] Referring now to FIGS. 23A-23D, a perspective view of the
femoral dilator 1300 (with inserted k-wire) is shown. The dilators
1300, which are of same size, dimension and shape like the intended
slit like tunnel, can be used to compress or dislocate remaining
bone structures to achieve the intended graft channels. Therefore,
the head 1302 is introduced in the femoral bores with the help of a
guiding k-wire 1301. The k-wire is set in an earlier procedure
during establishment of the femoral bores and is still in place
before the dilation procedure starts. The back of the k-wire, which
is placed in the central bore of the femoral bores, is introduced
in opening 1307 of head 1302 and the dilator is moved along the
axis of the k-wire to the femoral bores. Upon tapping on the back
1306 of handle 1304, the dilator moves along k-wire 1301, which
guides the head through the bores. This is facilitated by sloping
1308, which allows a gradual compression of the bores until the
desired profile 1309 (femoral channel) at its full extend is
reached (FIG. 23D).
[0192] Consecutively, the dilator is removed from the tibial
channel by pulling and tapping on protrusions 1305. This procedure
is facilitated by sloping 1310, which hinders that the head of the
dilator gets stuck upon removal.
Methods
[0193] In the following description, methods for the anatomically
correct reconstruction of ligaments employing flat, ribbon-like
grafts will be described. Exemplary, ligament structures within the
knee, with special focus on the anterior cruciate ligament are
addressed. The methods make use of the devices for ligament
preparation, introduction and fixation discussed above. It is
appreciated that in one variant of the invention, portions of the
graft are positioned to completely span or substantially span the
distance "slit like" femoral bone apertures in the femur in the
knee joint, while other portions of the graft span the "C-shaped"
or half-moon shaped apertures in the tibia in the knee joint.
Creation of ACL Insertion Sites
[0194] 1) Creating the Tibial Insertion Site of the ACL
[0195] Referring now to FIG. 17A, flowchart 1100 describes a
generic method for creating the tibial insertion site of the ACL in
seven steps. In order to measure and analyse the length and shape
of the insertion site, the torn ligament is first removed and the
insertion site is cleaned from residual ligament. As shown in FIG.
1B, the insertion site is a C-shaped or half-moon like structure,
with patient specific variations in size and curvature. The method
addresses the naturally occurring and anatomically correct
reconstruction of this structure. Upon having identified location,
size and orientation of the insertion site, an aiming device is
installed. Creation of the C-shaped or bent tunnel can be
accomplished by a bur, chisel or preferably, by multiple drilling
techniques.
[0196] By way of example, flowchart 1110 in FIG. 17A describes a
method for achieving this structure. With the help of device 200
multiple drill holes are arranged in a manner reflecting the
ribbon-like and C-shaped nature of the ligament insertion site.
Since these bores overlap, a curved slit is created. By using
appropriate drill sleeves 207 the tibial tunnel and respectively
insertion site can be adjusted to patient specific anatomy.
[0197] 2) Creating the Femoral Insertion Site of the ACL
[0198] Referring now to FIGS. 17A-17B, flowcharts 1100 and 1100'
describe generic methods for creating the tibial and femoral
insertion sites respectively in seven steps. In order to measure
and analyse the length and shape of the insertion site, the torn
ligament is removed and the insertion site is cleaned from residual
ligament.
[0199] As shown in FIG. 1C, the insertion site is a straight,
ribbon-like structure, with patient specific variations in length
and width. The method addresses the anatomically correct
reconstruction of this structure. Drilling of the slit-like tunnel
can be accomplished by using a bur, chisel or preferably, by
creating said structure by multiple drilling with drills
representing the width of the insertion site or the torn ligament,
respectively. Exemplary, flowchart 1110' in FIG. 17B and flowchart
1120' in FIG. 18B describes a method for achieving this structure.
With the help of device 300 multiple drill holes are arranged in a
manner that reflects the straight and ribbon-like nature of the
ligament insertion site. Since these bores overlap, a slit is
created. By using appropriate femoral aiming aid 300 the femoral
tunnel and respective insertion site can be adjusted to patient
specific anatomy. FIGS. 18A-18B illustrate the creation of tibial
tunnel and femoral tunnels in 10 steps in one variant of the
invention.
Graft Selection, Preparation and Fixation
[0200] Referring now to FIGS. 19A-19B, flowcharts 10120, 10120'
depict generic methods using components of system 3000 for creating
a ribbon-like ACL graft from either multiple parallel bundles or
from split tendons. In order to resemble the natural anatomy of the
ligament as closely as possible, multiple ways are possible to
create a ribbon-like structure preferably from a tendon graft.
[0201] By way of example, but not exclusively, possible graft donor
sites for the reconstruction of the ACL, and the way in which
autografts and allografts can be prepared, are as follows:
1. Hamstrings
[0202] To create a flat rectangular shape with hamstring tendons
two options are possible. (1) A graft made from four strained
hamstrings, which, in contrast to common round techniques, is
folded in a way in which the tendon strands lay parallel to each
other. (FIG. 21A). (2) The second possibility is to partially split
the round hamstring tendon longitudinally to create a flat tendon
(FIG. 21B). This novel way of hamstring use allows the creation of
tendon shapes, which closely resemble the "ribbon-shape" ACL.
2. Patellar Tendon
[0203] Alternatively, to aligning multiple tendon strands or
splitting the tendons, the graft can be carved out of the patellar
tendon in a flat and ribbon shaped fashion. Commonly it is
harvested with two bone blocks, which are prepared to fit a round
bone tunnel. The proposed technique employs a small, rectangular
bone block, but also uses without a bone block are possible.
3. Quadriceps Tendon
[0204] In the same way, a ribbon shaped part of the quadriceps
tendon (QT) can be carved out of the quadriceps tendon with or
without a bone block from the patella. Commonly, the QT has been
prepared in a round shape with a diameter up to 10 mm. With the
proposed technique a 6-8 cm long strip (depending on the use of a
bone block) of the central third of the QT is utilized. The strip
which is carved out of the quadriceps tendon is 10 to 15 mm wide
and 4 to 5 mm thick depending on the size of the ACL to be
replaced.
[0205] If no bone block is used, a 5-12 mm long portion of the
insertion zone of the quadriceps tendon to the patella can be
lifted from the patella and harvested together with the quadriceps
tendon-graft. This (thinner) portion of the graft can be flipped
back over the femoral graft fixation means to provide a round and
smooth edge for pulling in of the graft. With this proceeding a
splicing of the graft at the tunnel openings can be minimized
during pulling in of the graft.
4. Synthetic Ligaments
[0206] In the same way, the proposed reconstruction method can be
performed employing synthetic ligaments with a flat ribbon-like
appearance.
Graft Preparation Using Multiple Parallel Bundles.
[0207] Referring now to FIGS. 20A-20B, flowcharts 1130, 1130'
describes a method of preparing ribbon-like grafts from tendon
bundles. Currently, tendon grafts are harvested and multiple
bundles of the tendon are sewed together in different ways,
employing multiple suture techniques. All of these suture
techniques have in common, that a more or less cylindrical
structure with a round cross section is created, since these grafts
are intended to fill the cylindrical bores created with the
conventional reconstruction techniques.
[0208] By contrast, the method presented here allows reconstruction
of the torn ligament with a ribbon-like structure, which is
anchored in slit-like bore tunnels. The ribbon-like grafts from
tendon-bundles are made by means of devices 400 and 500.
Graft Preparation Using the Split-Tendon Technique
[0209] Referring now to FIG. 20B, flowchart 1130' describes a
method of preparing ribbon-like grafts by using the split-tendon
technique. In contrast to the ligament it should replace, the
harvested tendon, which is currently used for reconstruction has
cylindrical shape with a round cross section. In order to create a
flat, ribbon-like structure, the tendon is split by an incision
reaching the cylinder axis, and subsequently unfolded into two
connected halves. This incision can be accomplished by using a
knife, sharp spoon or anything the like. In a preferred embodiment
device 600 is used to incise the tendon. It allows longitudinal
cutting of the tendon, with minimal damage to the parallel tendon
fibres, which could negatively influence the stability of the
graft. The flat tendons are secured by stitching to femoral and
tibial fixation means, which allow the upholding of the ribbon
shaped nature of the graft.
[0210] In a variation, the flat and ribbon shaped graft is carved
out of a tendon (e.g. patella tendon, quadriceps tendon) as a
rectangular strip and secured by stitching to femoral and tibial
fixation means, which allow the upholding of the ribbon shaped
nature of the graft.
Insertion and Fixation of Ribbon-Like Grafts
[0211] Referring now to FIG. 20C, flowchart 1140 describes a method
for inserting and fixing a ribbon-like graft in the tibial and
femoral tunnel or pocket. In further variants of the invention, a
system for the anatomical reconstruction of the anterior cruciate
ligament to mimic a naturally occurring ACL in biomechanical
function and stability includes devices selected from a list of
devices that include one or more of: aiming device 200 for the
creation of the tibial bone tunnel; aiming device 300 for the
creation of the femoral bone tunnel or pocket; guiding device 900
for positioning a guide wire at the femoral insertion site; a
device for the attachment of ribbon-like grafts to the femoral
insertion site; a device for the attachment of ribbon-like grafts
to the tibial insertion site; an optional device 1000 for
tensioning the graft; and, devices 500, 600 for preparing flat,
ribbon-like grafts.
[0212] Aiming device 200 for the creation of the tibial bone tunnel
with a bent or C-shaped appearance includes at least one or more
portions thereof selected from: an intra-articular portion 203
configured to position and hold a template 206 at an
intra-articular insertion site; and, an extra-articular portion
202, holding an extra-articular drill sleeve 207, wherein intra-
and extra-articular portions are rigidly connected. Aiming device
300 for the creation of a femoral bone tunnel or pocket with
straight, slit-like appearance, includes at least one of the
following portions and features thereof: a guiding tube 303 for the
aiming of a guide wire; drill channel(s) 304 adjacent to said
guiding tube; and, viewport for an arthroscope 307 configured to
allow simultaneous observation of a guide wire and insertion
site.
[0213] The device for the attachment of ribbon-like grafts to the
femoral insertion site includes a device which includes: device 400
for the attachment of ribbon-like grafts from multiple tendon
bundles; and/or device 700 for the attachment of ribbon-like grafts
from split tendons. The device for the attachment of ribbon-like
grafts to the tibial insertion site includes a device selected from
a list of devices, and/or one or more features of the devices
described below: a device for the attachment of grafts made from
multiple tendon bundles, chosen from a list including: device 510'
comprising a rigid flat body with holes 551, 552 for cord insertion
and knotting; device 520' comprising a rigid flat body with a
depression 563 accepting the knot; device 530' comprising a rigid
flat body with holes adapted for fastening the inserted cords by
wedging before tying a knot device 540' comprising a rigid flat
body 580 with a sloped extension 585 with slits 586 permitting
knotting and tensioning single cords; and, device 800 for the
attachment of ribbon-like grafts made from split tendons. Device
500 is adapted for the preparation of flat, ribbon-like grafts from
multiple tendon bundles in one variant. In another variant, device
600 is adapted for the preparation of flat, ribbon-like grafts from
split tendons.
[0214] Device for the creation of a first bone tunnel has an
adaptor for an intra-articular template, whose inner opening
represents the bore, which will be formed by drilling when the
corresponding extra-articular drill-sleeve will be employed. The
adaptor of the intra-articular template features a spike (or
similar appliance) for fixing the intra-articular portion of the
device to a surface within the joint (e.g. the tibial plateau).
[0215] The intra-articular template represents the shape and length
of the patient specific insertion site of the ligament. (e.g. bent,
arched or c-shaped for the tibial insertion site of the anterior
cruciate ligament). The extra-articular drill sleeve corresponds to
the intra-articular template in one variant of the invention. The
extra-articular drill sleeve features at least one drill sleeve for
the guidance of a driller/bur and at least one guidance tube for a
guide-wire. Drill tunnels for guidance of the drills can not only
be formed as cylindrical holes, but also segments of cylindrical
holes big enough to guide a drill/bur. The bore(s) created by using
the guidance tube for the driller(s)/bur(s) overlap(s) with the
bore created after over drilling of the guide wire. Alternatively,
guidance tubes for the drill/bur can be of an elongated and bent
cross-section, along which a bur or drill can be moved to form a
slit-like opening in the bone.
[0216] The extra-articular portion of the aiming device features a
holder for the drill-sleeve, which can be moved along the
drill-axis and be locked with a screw or similar device. The holder
of the drill sleeve can fix the drill-sleeve by slight compression
of the drill sleeve or a similar action. The extra-articular drill
sleeve may feature at least one tube (preferably slotted), through
which a spike/guide-wire can be moved along the drill axis, which
is used to stabilize the extra-articular portion of the device to
bone. The spike(s)/guide-wire(s) (which is/are intended to
stabilize the extra-articular portion of the device to bone) in the
drill sleeve can be fixed by slight compression of the drill sleeve
or a similar action. The spike(s)/guide-wire (s) (which is/are
intended to stabilize the extra-articular portion of the device to
bone) is/are part of the extra-articular drill sleeve holder.
[0217] The device for the creation of a second bone tunnel has at
least one drill sleeve for the guidance of a driller/bur and at
least one guidance tube for a guide-wire. The bores created with
the device represent the shape and length of the patient specific
insertion site of the ligament. (e.g. straight and ribbon like at
the femoral insertion site of the anterior cruciate ligament).
Drill tunnels for guidance of the drills can be formed not only as
cylindrical holes, but also segments of cylindrical holes big
enough to guide a drill/bur. The depth of the bores can be
controlled by reading the depth marks of the driller at the edge of
the bore sleeve before and during drilling. The device can be used
to perform drilling through the whole bone to form a uniform tunnel
OR can be used to create a pocket in the bone. The device can be
used to create a pocket in the bone with a (central) tunnel, which
reaches the other cortex of the bone, thereby minimizing the damage
to the bone. The bore(s) created by using the guidance tube for the
driller(s)/bur(s) overlap(s) with the bore created after over
drilling of the guide wire. Alternatively, guidance tubes for the
drill/bur can be of elongated cross-section, along which a bur or
drill can be moved to form a slit-like opening in the bone.
[0218] The device features a view-port for an arthroscope, which
allows direct visualization of the tip of the guide-wire and the
graft insertion site.
[0219] The guide-wire is equipped with a removable stamping
adaptor, which can be used to transiently fix the guide-wire by
tapping or pushing on the stamping adaptor in the longitudinal
direction of the guide-wire. The guiding device for the right
allocation of the femoral bone tunnel features a bent handle to
ease the access to the femoral insertion site in an arthroscopic
setting. Furthermore, it features two "noses" for alignment of the
device with the posterior aspect of the femoral condyle and with
the posterior lateral cortex of the femur.
[0220] A system for the ribbon-like attachment of multiple tendon
bundles includes one or more of the following devices and/or
features thereof: a button like device for the mounting and
fixation of multiple bundle tendon grafts; a device for the
alignment of individual bundles using a "weaving-technique"; and, a
device for fixing a ribbon-like tendon graft with at least two
cords.
[0221] The button-like device has an elongated body 607, which
holds a sling or loop 601, which is subdivided by at least one
partitioning 605. The partitioning can be either fixed 605 or can
move along the sling or loop, as exemplified in FIG. 12C. The
strands of the tendons form a linear alignment, where the upper
strand is held apart by the lower strand of the tendon.
Alternately, the strands of the tendons form a linear, semi-rigid
structure of the individual tendon bundles, which still can be bent
transversally. The strands of the tendons form a linear, semi rigid
structure of the individual tendon bundles, which still can be
passed through a non-linear (e.g. C-shaped) bone tunnel.
[0222] The pushing together of the individual tendon bundles is
hindered by a sequential pulling in, which favours a smooth pulling
in of the graft, especially in slit-like bone tunnels with a small
width. The device for the alignment of individual bundles using a
"weaving-technique" features a base-plate with holes 505, which are
connected with slits 506. The pulling ends of a cord (or the like,
501 and 502) as well as the loops 503 are on the front side of the
base plate, while the connecting sections of the cord are on the
backside of the base plate. The size of the holes is large enough
to allow passing of a cord or suture-material 501,502, while the
slits are more narrow and allow the passing of the cord only when
force is applied to the cord and the walls of the slits are
dilated.
[0223] A linear mounting for the opposing side of a multi-bundle
graft is formed, where the individual strands are pressed together,
but cannot slip over each other, thereby eliminating the formation
of a bulky graft. This is especially important in the case where
slit-like tunnels with a small width are employed. The cord slips
through the slits of the base plate if enough force is applied, and
the linear tendon/cord construct is released from the base
plate.
[0224] The device for fixing a graft with two cords has a flat
rigid body, which is larger than the created bone tunnels and has
two openings to accept the two cords, which are attached to the
graft. The flat rigid body has a deepening or grooves with two
openings, which accepts the knot after knotting of the two cords,
which are attached to the graft. The openings are narrower to the
center of the device to allow a wedging together of the cords
before knotting. The cords can be tensioned after knotting by
pulling them over a slope to a securing position more distant from
the graft. The cords can be tensioned optionally. Alternatively,
the cords can be tensioned and fixed by graft fixation means
exemplified in FIG. 10A. The device for fixing a graft with two
cords has a flat rigid body with sleeve and rotation of an inner
fastening member results in displacing cut outs from the openings
in the sleeve, whereby the cords are compressed between the jagged
inner fastening member and wall of the sleeve.
[0225] A system for the ribbon-like attachment of a flat
split-tendon includes one or more of the following devices and
features thereof: a button-like device for the mounting and
fixation of a flat split-tendon graft; a buckle-like device for the
mounting and fixation of a flat split-tendon graft; and/or a device
for preparing a flat tendon graft out of a cylindrical tendon
graft.
[0226] The button-like device has an elongated body (607), which
holds a tape sling or loop, which has an opening with an adjacent
stitching area. The stitching area is used for the fixation of the
flat tendon in a planar way by securing the edges and the mid of
the tendon over the distance of the opening. A semi-rigid structure
is formed, where the tendon graft cannot slip together, but a
transversal bending is still possible as shown in FIG. 13B.
[0227] The buckle like device for the mounting and fixation of a
flat split-tendon graft features a tape-like structure (801) with
an opening and stitching area. The tape-like structure is fastened
and fixed with an extra-osseous element at the exit of the bone
tunnel by passing the tape through a slit in the buckle-like
device. The buckle-like device features at least one adjacent slit,
which can be open on one side (807 and 809) or closed. The
buckle-like device features preferably two adjacent slits (807 and
809) which are open on one side or on opposite sides. The
buckle-like device features an angulated slit, preferably in an
angulation that the tape and the extra-osseous element become
wedged together, when tension is applied to the tape and the
extra-osseous element is locked at the exit of the bone tunnel.
[0228] The tension of the tape (and consequently the graft) can be
further adjusted by pulling of the tape and a first fastening of
the tape is accomplished by the mechanism described herein. The
tape can be further Secured by strapping back in a first adjacent
slit (807) and then to a second slit. The application of knots for
the fixation of graft structures under tension is avoided and
therefore a loosening of the tension of the cord/tape is omitted
with this proceeding. The tape without the buckle-like device can
be secured by introduction of a screw, which presses the tape
towards the bone-tunnel wall.
[0229] In general, the flat prepared tendon structure can also be
secured on the tibial side to device (s) exemplified in FIG. 13C
(embodiments c-h) or FIG. 13D, where cords protrude from the
various graft fixation means. In this case, fixation can be
achieved by an extra-osseous element 510', 520', 530', 540' and/or
550', which fixes the cords coming from the graft and have been
described in more detail in the section describing the tibial
fixation of a multi bundle graft. In a preferred embodiment, the
tibial side of a graft prepared from a split tendon is secured by
device shown in FIG. 13D (embodiment c) and fixed to the tibia by
employing device 550'.
[0230] A flat tendon graft is prepared from a cylindrical graft by
longitudinal splitting. A cylindrical graft is placed in a device,
such as that shown in FIGS. 12A-12C, which cuts the cylindrical
graft to its approximated middle portion, thereby allowing an
unfolding of the cylindrical graft to a flat structure. The device
may include precautionary measures or measurement points, which
avoid total cutting or splitting of the graft, such as a set
maximum penetration into the cutting canal 602.
[0231] The device features standardized adaptors for conventional
surgical blades. A cylindrical graft is placed in a device, which
fixes the graft on its distant side and has a slide with an
attached cutting device, which moves longitudinal to the inserted
graft, thereby cutting the graft in its longitudinal direction. The
cylindrical graft is placed in a device with a fixed cutting device
and the graft is pulled through the device and is cut in its
longitudinal direction.
[0232] A method for creation of bone tunnels representing the
insertion site of a ligament structure (e.g. the anterior cruciate
ligament) includes the following steps: performing the measurement
of the insertion sites (e.g. tibial and femoral); choosing the
location and orientation of the insertion sites (e.g. tibial and
femoral); positioning of an aiming device(s) over the chosen
location(s); creating tunnels OR incomplete drilling/burring of
said bores to create a pocket-like structure in the bone, which
resembles the insertion site or naturally occurring footprint of
the ligament attachment point. (Half-moon or C-shaped at the tibial
insertion site and straight and ribbon shaped at the femoral
attachment site); removing the aiming device(s); and, optionally
cleaning of the edges by using a drill, bur, rasp, chisel, knife or
similar device.
[0233] A method of multi-bundle tendon preparation, which results
in a ribbon-like structure to reconstruct a ligament is also
included in the invention. The method including the steps of:
harvesting the tendon to be used for the tendon preparation;
preparing the graft, which allows the mounting and fixation of the
tendon in a way that the individual strands are arranged in a
ribbon-like, flat fashion; and, preparing the individual strands of
the graft in a linear arrangement on the opposite side of the
graft.
[0234] The invention includes another variant in which a method of
a flat tendon preparation and attachment, which results in a
ribbon-like structure to reconstruct a ligament. The method
including the steps of: harvesting the tendon to be used for tendon
preparation; preparing the round tendon structure into a flat,
ribbon-like structure by cutting or blunt incising along the
longitudinal axis of the tendon following the tendon fibres;
attaching the flat tendon to a structure, which allows a spanning
of the flat tendon orthogonally (or near orthogonal) to its
longitudinal axis; attaching of the opposite side of the flat
tendon to a device, which allows the spanning of the flat tendon
orthogonally (or near orthogonal) to its longitudinal axis; and,
fixing the flat tendon in both slit-like straight or bent bone
tunnels. Alternatively, flat, ribbon-like grafts can be made by
carving portions (strips) out of a bigger tendon (e.g. patella
tendon, quadriceps tendon).
Graft Fixation Using the Split Tendon Technique
[0235] In yet another variant, a method of multi-bundle tendon
preparation, which results in a ribbon-like structure to
reconstruct a ligament is described in the invention. The method
including the steps of: harvesting the tendon to be used for the
tendon preparation; preparing the graft, which allows the mounting
and fixation of the tendon in a way that the individual strands are
arranged in a ribbon like, flat fashion; and, preparing the
individual strands of the graft in a linear arrangement on the
opposite side of the graft.
[0236] In yet another variant, a method of a flat tendon
preparation and attachment, which results in a ribbon-like
structure to reconstruct a ligament, is described herein. The
method includes the steps of: harvesting the tendon to be used for
tendon preparation; preparing the round tendon structure into a
flat, ribbon-like structure by cutting or blunt incising along the
longitudinal axis of the tendon following the tendon fibres;
attaching the flat tendon to a structure, which allows a spanning
of the flat tendon orthogonally (or near orthogonal) to its
longitudinal axis; attaching of the opposite side of the flat
tendon to a device, which allows the spanning of the flat tendon
orthogonally (or near orthogonal) to its longitudinal axis; and,
fixing the flat tendon in both slit-like straight or bent bone
tunnels.
[0237] FIG. 24 illustrates an overall system 3000 architecture view
and components of system with exemplary system devices 200, 400,
500, 550 described herein (of course, additional devices described
herein are also used in variants of the invention and incorporated
into system 3000 where desired), and in which a plurality of the
system 3000 devices described herein are used in various
combinations. It is appreciated that all of the system 3000 devices
described herein are used in various combinations to enable the
system and methods described herein. It is appreciated that one or
a plurality of the devices are used in system 3000 to achieve the
stated purposes of reconstructing a portion of a knee joint with a
torn anterior cruciate ligament using a graft, wherein the graft
having a first end and a second end, and whereby naturally
occurring attachment footprints of a native ACL are mimicked to
provide biomechanical stability to the knee joint.
[0238] As illustrated in FIGS. 2A-20C, 22A-23D, the invention
provides a system and methods for preparing a first and second bone
for a graft procedure. The system includes a device for creating on
the first bone an entrance point mimicking a first native ligament
attachment footprint (1002 FIG. 1B), the first native ligament
insertion site 1000 optionally being a substantially half-moon
shaped footprint 1002, the device (200, 200', FIGS. 2A and 4C)
having an appliance for sequential drilling or burring of
overlapping bores, which are arranged in a c-shaped manner to
create said c-shaped insertion site; and a device (300, FIGS.
5A-6C) for creating on the second bone an entrance point mimicking
a second native ligament attachment footprint 1102, the second
native ligament attachment footprint 1102 optionally being a
substantially slit shaped footprint, the device (300) having an
appliance for sequential drilling or burring of overlapping bores,
the bores being arranged in a slit-shaped manner to create a
slit-shaped insertion site, the slit-shaped insertion site
substantially conforming in size to a corresponding aperture
created with the first device.
[0239] As shown in FIGS. 20A-20B, the system and method further
includes a third device for creating a substantially ribbon-like
ACL graft, said graft having a first end and a second end, the
device selected from a group consisting of a device for creating a
substantially ribbon-like ACL graft, said graft having a first end
and a second end, a device having an appliance allowing to maintain
the ribbon-like appearance of the graft by affixing parallel tendon
bundles or affixing tendons which are split and prepared in a way
to give a flat, ribbon like appearance, and a device for affixing
portions of a tendon which have been prepared to give a
substantially flat and ribbon like appearance, and optionally,
includes a device for fixing at least a portion of the first end of
the graft at a tibial anchor point, the device having a flat
structure attached to a mechanism, the mechanism allowing
immobilization of the attached graft by wedging and blocking of the
attached fixation means.
[0240] As shown in FIGS. 9A-9D, the system and method also include
devices 510' to 540' for fixing at least a portion of the second
end of the graft in a femoral anchor point, the device having a
button-like device for the extra-osseous fixation of the graft, the
graft being connected to an appliance, the appliance allowing the
affixing of a substantially flat graft to a flat structure on the
fifth device by attaching the graft to said flat structure, the
flat structure being flexible enough to first pass through a
c-shaped bone tunnel and second through said slit-shaped bone
tunnel.
[0241] In another variant and as shown in FIGS. 8A-8I, the
invention provides a graft and a method for creating a graft for
ACL reconstruction. The graft includes a first portion which is
shaped and dimensioned to substantially conform to a slit shaped
bone entrance point. A second portion is shaped and dimensioned to
be substantially ribbon like, and a third portion which is shaped
and dimensioned to substantially conform to a C-shaped bone
entrance point. The system is used in a method for creating a graft
for ACL reconstruction and the system includes a device for making
the graft as described herein.
[0242] As shown in FIGS. 24, 17A-18B and the other figures herein,
the system 3000 and method is used for reconstructing a portion of
a knee joint with a torn anterior cruciate ligament using a graft.
The graft has a first end and a second end. It is appreciated that
the naturally occurring attachment footprints of a native ACL are
mimicked to provide biomechanical stability to the knee joint. The
system includes a first immobilizer having a flat structure
attached to a button-like device for the extra-osseous fixation of
the graft, the first immobilizer for positioning and use at a
portion of the first end of the graft in, or optionally on a femur,
at least a portion of the graft adapted for passing through a
substantially slit shaped aperture on the femur. Also provided is a
second immobilizer having a flat structure attached to a mechanism,
the mechanism allowing immobilization of the attached graft by
wedging and blocking of the attached fixation means.
[0243] The second immobilizer is used for positioning and use at a
portion of the second end of the graft in, or optionally on a
tibia, wherein at least a portion of the graft is adapted to pass
through a substantially C-shaped aperture on the tibia.
[0244] In another variant, the invention provides a method of
reconstructing a knee joint with an anterior cruciate ligament tear
using a graft. The graft has a first end and a second end. The
method includes the steps of: immobilizing a first end of the graft
on a femur, at least a portion of the graft passing through a
substantially slit shaped aperture on the femur; immobilizing a
second end of the graft on a tibia, at least a portion of the graft
passing through a substantially C-shaped aperture on the tibia; and
affixing the ends of the graft on their respective insertion sites
in a manner mimicking naturally occurring attachment insertion
sites of a native ACL, in order to provide biomechanical stability
to the knee joint.
[0245] In another variant, the invention provides a system 3000 and
method (FIGS. 17A-18B) of providing substantially equal
biomechanical stability for a bipedal mammal. The bipedal mammal
has a native ACL in a first knee joint and a torn ACL in a second
knee joint in the clinical setting. The method includes
reconstructing the torn ACL in the second knee joint to obtain a
reconstructed ACL, the reconstructed ACL including a first portion
of a graft passing through a substantially slit-like aperture in a
first bone, and a second portion of the graft passing through a
substantially C-shaped aperture in a second bone; affixing the ends
of the graft on their respective insertion sites in a manner
mimicking naturally occurring attachment insertion sites of a
native ACL, in order to provide biomechanical stability to the knee
joint; and, allowing for healing with physiotherapy and supervised
recovery, whereby thereafter, the biomechanical stability of the
first knee joint is substantially similar to the biomechanical
stability of the second knee joint.
[0246] In yet a further variant and as illustrated in FIGS. 24,
17A-17B, the invention includes a system 300 and method of
providing substantially equal biomechanical stability for a bipedal
mammal having a native ACL in a first knee joint and torn ACL in a
second knee joint, whereby after healing, the biomechanical
stability of the knee joints are substantially similar, the method
comprising the steps of: forming a graft of an anatomically correct
reconstructed ACL; forming an ACL footprint mimicking a native ACL
footprint in the second knee joint; passing a first portion of the
graft that passes through a substantially slit-like aperture in a
first bone; passing a second portion of the graft through a
substantially C-shaped aperture in a second bone; affixing the ends
of the graft on their respective insertion sites in a manner
mimicking naturally occurring attachment insertion sites of a
native ACL, in order to provide biomechanical stability to the knee
joint; and allowing for healing with physiotherapy and supervised
recovery, whereby thereafter, the biomechanical stability of the
first knee joint is substantially similar to the biomechanical
stability of the second knee joint.
[0247] In yet another variant and as illustrated in FIGS. 2A-2C,
the invention includes a system 300 method of preparing a tibia for
an anatomically correct ACL reconstruction using various devices
forming a part of system 3000, including devices 200 and 200'. The
method includes cleaning and identifying a tibial ACL footprint;
measuring the tibial ACL footprint with a template; locating and
orienting a tibial insertion site; positioning a tibial aiming
device; drilling a bone tunnel, or optionally a pocket, correlated
to the tibial insertion site in a substantially C-shaped
configuration; removing the tibial aiming device; and, optionally
cleaning drilling edges.
[0248] In yet further variant and as illustrated in FIGS. 5A-5D,
the invention provides a system 3000 and method of preparing a
femur bone for an anatomically correct ACL reconstruction. The
method includes the steps of: cleaning and identifying a femoral
ACL footprint; measuring the femoral ACL footprint with a template;
locating and orienting a femoral insertion site; positioning a
femoral aiming device; drilling a bone tunnel, or optionally a
pocket, correlated with the femoral insertion site in a
substantially slit shaped configuration; removing the femoral
aiming device; and optionally cleaning drilling edges. Device 300
is used in the system 3000 and method in this variant of the
invention.
[0249] The invention provides a system 3000, devices forming the
system, and a method of creating a tibial bone tunnel during a
ligament reconstruction surgery, comprising the steps of: cleaning
and identifying a tibial footprint; measuring a tibial footprint
with a template; attaching or adjusting an intra-articular template
to a tibial guiding device; attaching or adjusting a corresponding
drill sleeve to the tibial guiding device; drilling to provide a
guide-wire or a drill which stabilises the tibial guiding device;
orienting the tibial guiding device; drilling adjacent bores or
adjacent k-wires in case where a drill was set to stabilise the
tibial guiding device; removing the tibial guiding device; drilling
a bore over the guide-wire or adjacent guide wires; and, optionally
cleaning drilling edges.
[0250] In yet further variant, the invention provides a system
3000, devices which are included in system 3000 and a method of
creating a femoral bone tunnel, comprising the steps of: cleaning
and identifying a femoral footprint; measuring a femoral footprint
with a template; introducing a k-wire with a stamping device with a
corresponding femoral guiding device; setting the k-wire using an
aiming template and an arthroscope; drilling to provide a
guide-wire or a drill which stabilises the femoral guiding device;
orienting the femoral guiding device; drilling adjacent bores or
adjacent k-wires in case where a drill was set to stabilise the
femoral guiding device; removing the femoral guiding device;
drilling a bore over the guide-wire; and, optionally cleaning
drilling edges.
[0251] In yet another variant, the invention provides a method of
preparing a graft for a ligament reconstruction procedure,
comprising the steps of: harvesting a tendon; cleaning the tendon;
arranging individual tendon strands in a substantially ribbon-like,
flat manner to mount and fixate the tendon; and, preparing the
individual tendon strands in a linear arrangement.
[0252] In yet further variant, the invention provides a system
3000, and devices used in the system and forming the system 3000,
and a method of preparing a graft for a ligament reconstruction
procedure, comprising the steps of: harvesting a tendon to obtain a
round tendon structure; cleaning the round tendon structure;
preparing a substantially flat, ribbon-like structure from the
round tendon structure along a longitudinal axis of the round
tendon structure following tendon fibers, the substantially flat,
ribbon-like structure having a first side and a second side;
spanning the first side of the substantially flat, ribbon-like
structure substantially orthogonally to the longitudinal axis of
the substantially flat, ribbon-like structure by attaching the
substantially flat, ribbon-like to an attachment structure; and,
spanning the second side of the substantially flat, ribbon-like
structure substantially orthogonally to the longitudinal axis by
attaching the substantially flat, ribbon-like to an attachment
structure.
[0253] In yet further variant, the invention provides a method of
preparing a graft for a reconstruction procedure, comprising the
steps of: harvesting a tendon having a plurality of tendon strands;
cleaning the tendon; providing a split-button device having a lower
partition and an upper partition; introducing the tendon into the
lower partition; introducing the tendon into the upper partition;
providing a fiber-pod having separate fields and loops; laying each
tendon strand in a separate field; weaving the plurality of tendon
strands through the loops with a plurality of pull chords;
tightening the tendon strands by pulling the pull chords; and,
optionally securing the tendon strands with sutures.
[0254] The invention provides a system 3000, devices within system
3000, and a method of preparing a graft for a procedure, comprising
the steps of: harvesting a flat, ribbon-like portion of a tendon
(e.g. patella or quadriceps tendon); cleaning the tendon portion,
preparing a substantially flat tendon structure; and attaching said
structure to fixation means allowing the upholding of a flat
appearance of the graft.
[0255] In yet further variant of the invention, it provides a
system 3000 (FIG. 24) in which the system is used to execute a
method of reconstructing a ligament using a first bone tunnel and a
second bone tunnel, comprising the steps of: creating the first
bone tunnel according to a first native ligament insertion site;
creating a second bone tunnel according to a second native ligament
insertion site; preparing a substantially ribbon-like, flat graft,
the graft having a first end and a second end; pulling in the graft
via the first bone tunnel into the second bone tunnel; fixing a
portion of the first end of the graft in the second bone tunnel;
tightening and fastening the graft; and, fixing a portion of the
second end of the graft in the first bone tunnel. In this variant
of the method the first bone tunnel is a tibial bone tunnel, and
the second bone tunnel is a femoral bone.
[0256] It should be appreciated that the particular implementations
shown and herein described are representative of the invention and
its best mode and are not intended to limit the scope of the
present invention in any way. Moreover, the system contemplates the
use, sale and/or distribution of any goods, services or information
having similar functionality described herein.
[0257] The specification and figures should be considered in an
illustrative manner, rather than a restrictive one, and all
modifications described herein are intended to be included within
the scope of the invention claimed. Accordingly, the scope of the
invention should be determined by the appended claims (as they
currently exist or as later amended or added, and their legal
equivalents) rather than by merely the examples described above.
Steps recited in any method or process claims, unless otherwise
expressly stated, may be executed in any order and are not limited
to the specific order presented in any claim. Further, the elements
and/or components recited in apparatus claims may be assembled or
otherwise functionally configured in a variety of permutations to
produce substantially the same result as the present invention.
Consequently, the invention should not be interpreted as being
limited to the specific configuration recited in the claims.
Benefits, other advantages and solutions mentioned herein are not
to be construed as critical, required or essential features or
components of any or all the claims.
[0258] As used herein, the terms "comprises", "comprising", or
variations thereof, are intended to refer to a non-exclusive
listing of elements, such that any apparatus, process, method,
article, or composition of the invention that comprises a list of
elements that does not include only those elements recited, but may
also include other elements described in the instant specification.
Unless otherwise explicitly stated, the use of the term
"consisting" or "consisting of" or "consisting essentially of" is
not intended to limit the scope of the invention to the enumerated
elements named thereafter, unless otherwise indicated. Other
combinations and/or modifications of the above-described elements,
materials or structures used in the practice of the present
invention may be varied or adapted by the skilled artisan to other
designs without departing from the general principles of the
invention.
[0259] The patents and articles mentioned above are hereby
incorporated by reference herein, unless otherwise noted, to the
extent that the same are not inconsistent with this disclosure.
[0260] Other characteristics and modes of execution of the
invention are described in the appended claims. Further, the
invention should be considered as comprising all possible
combinations of every feature described in the instant
specification, appended claims, and/or drawing figures, which may
be considered new, inventive and industrially applicable.
[0261] Additional features and functionality of the invention are
described in the claims appended hereto. Such claims are hereby
incorporated in their entirety by reference thereto in this
specification and should be considered as part of the application
as filed.
[0262] Multiple variations and modifications are possible in the
embodiments of the invention described here. Although certain
illustrative embodiments of the invention have been shown and
described here, a wide range of changes, modifications, and
substitutions is contemplated in the foregoing disclosure. While
the above description contains many specific details, these should
not be construed as limitations on the scope of the invention, but
rather exemplify one or another preferred embodiment thereof. In
some instances, some features of the present invention may be
employed without a corresponding use of the other features.
Accordingly, it is appropriate that the foregoing description be
construed broadly and understood as being illustrative only, the
spirit and scope of the invention being limited only by the claims
which ultimately issue in this application.
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