U.S. patent application number 10/300183 was filed with the patent office on 2003-05-08 for implantable tissue fixation devices and methods of tissue approximation.
This patent application is currently assigned to Tendon Technology, Ltd.. Invention is credited to Coleman, Carl R., Hughes, Kenneth E., Lubbers, Lawrence M..
Application Number | 20030088270 10/300183 |
Document ID | / |
Family ID | 25516214 |
Filed Date | 2003-05-08 |
United States Patent
Application |
20030088270 |
Kind Code |
A1 |
Lubbers, Lawrence M. ; et
al. |
May 8, 2003 |
Implantable tissue fixation devices and methods of tissue
approximation
Abstract
Implantable devices and methods for fixation of soft tissue to
soft tissue or soft tissue to bone tissue. Generally, the devices
can include a body having at least a first area with a plurality of
projections extending from the first area for attaching to the soft
tissue, and a second area discrete from the first area. The body
has physical characteristics sufficient to approximate or to
support the soft tissue adjacent the first area with respect to the
second area. The plurality of projections are configured to attach
to the soft tissue and to distribute tension between the first area
and the soft tissue. A soft tissue to bone tissue approximation
device is configured to be attached to bone tissue and, using a
plurality of projections, also attached to soft tissue.
Inventors: |
Lubbers, Lawrence M.;
(Columbus, OH) ; Hughes, Kenneth E.; (Pataskala,
OH) ; Coleman, Carl R.; (Powell, OH) |
Correspondence
Address: |
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI
OH
45202
US
|
Assignee: |
Tendon Technology, Ltd.
|
Family ID: |
25516214 |
Appl. No.: |
10/300183 |
Filed: |
November 20, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10300183 |
Nov 20, 2002 |
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09969947 |
Oct 3, 2001 |
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09969947 |
Oct 3, 2001 |
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PCT/US99/24098 |
Oct 18, 1999 |
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PCT/US99/24098 |
Oct 18, 1999 |
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08928866 |
Sep 12, 1997 |
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6083244 |
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60026101 |
Sep 13, 1996 |
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60043086 |
Apr 8, 1997 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/0414 20130101;
A61B 2017/0437 20130101; A61B 2017/0646 20130101; A61B 2017/0648
20130101; A61B 17/685 20130101; A61B 17/683 20130101; A61B 17/1146
20130101; A61B 2017/0409 20130101; A61B 2017/0406 20130101; A61B
2017/0461 20130101; A61B 2017/06057 20130101; A61B 2017/0412
20130101; A61B 2017/0456 20130101; A61F 2002/0829 20130101; A61B
2090/0801 20160201; A61B 2017/0408 20130101; A61B 2017/0462
20130101; A61B 2017/0445 20130101; A61F 2002/0888 20130101; A61B
2017/0496 20130101; A61B 2017/0641 20130101; A61B 2017/0649
20130101; A61F 2002/0835 20130101; A61B 2017/044 20130101; A61B
17/0401 20130101; A61B 2017/06028 20130101; A61B 2017/0488
20130101; A61F 2/0805 20130101; A61B 2017/0404 20130101; A61F
2002/0858 20130101; A61B 17/0487 20130101; A61B 2017/0458 20130101;
A61B 17/064 20130101; A61B 17/1686 20130101; A61F 2/0811 20130101;
A61B 2017/0427 20130101; A61B 2017/0441 20130101; A61B 2017/0464
20130101; A61B 2017/0454 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 017/08 |
Claims
1. An implantable device for fixation to soft tissue, comprising;
a) a body having: i) at least a first area with a plurality of
projections extending from the first area for attaching to the soft
tissue, and ii) a second area discrete from the first area, wherein
the body has physical characteristics sufficient to approximate or
to support the soft tissue adjacent the first area with respect to
the second area, and wherein the plurality of projections are
configured to attach to the soft tissue and to distribute tension
between the first area and the soft tissue.
2. The implantable device of claim 1 wherein said plurality of
projections comprise burrs.
3. The implantable device of claim 1 wherein said body includes
said projections on opposite sides thereof.
4. The implantable device of claim 3, wherein said plurality of
projections comprise burrs.
5. The implantable device of claim 1 wherein said plurality of
projections extending from said body are varied in orientation on
said body.
6. The implantable device of claim 1 wherein said body comprises a
solid material.
7. The implantable device of claim 6 wherein said solid material
comprises a biodegradable material.
8. The implantable device of claim 1 wherein said body and said
plurality of projections comprise a polymer or copolymer.
9. The implantable device of claim 1 wherein said body comprises
opposing end areas and a central area located between said opposing
end areas.
10. The implantable device of claim 9 wherein said plurality of
projections are located at said opposing end areas.
11. The implantable device of claim 10 wherein said central area is
without projections.
12. The implantable device of claim 9 wherein said plurality of
projections at one of said end areas are canted toward said
plurality of projections at the opposing end area.
13. The implantable device of claim 1 wherein said body is tubular
in shape and has an outside surface, an inside surface, a first
end, and a second end opposing said first end.
14. The implantable device of claim 13 wherein said plurality of
projections are on said first end and said plurality of projections
are canted toward said second end.
15. The implantable device of claim 14 wherein said second end
includes projections extending therefrom and canted toward said
first end.
16. An implantable tissue approximation device comprising: a) a
biodegradable body having: i) opposing first and second ends
separated by a center area, ii) discrete first and second contact
areas respectively adjacent the opposing first and second ends, and
iii) a plurality of biodegradable projections extending from the
first and second discrete contact areas, wherein 1) the plurality
of biodegradable projections are configured to attach to soft
tissue adjacent the first and second discrete contact areas, 2) the
biodegradable body has physical characteristics sufficient to
approximate tissue adjacent the first contact area with respect to
the discrete second contact area, and 3) wherein the plurality of
biodegradable projections are configured to distribute tension
between the first and second contact areas and the respective
adjacent soft tissue.
17. An implantable tissue approximation device comprising: a bone
tissue anchor portion, and a soft tissue anchor portion, said soft
tissue anchor portion having a plurality of projections extending
therefrom, and said soft tissue anchor portion coupled with said
bone tissue anchor portion, wherein said bone tissue anchor portion
is configured to be attached to bone tissue and said plurality of
projections of said soft tissue anchor portion are configured to be
attached to soft tissue whereby the coupling between the bone
tissue anchor portion and the soft tissue anchor portion is used to
approximate the soft tissue to the bone tissue.
18. The implantable tissue approximation device of claim 17,
wherein said soft tissue anchor portion further comprises a flat
body with said projections extending from a surface thereof, said
projections serving to distribute tension between soft tissue and
said flat body after said flat body and said bone anchor portion
are secured, respectively, to the soft tissue and the bone
tissue.
19. The implantable tissue approximation device of claim 18,
wherein said projections further comprise burrs.
20. The implantable tissue approximation device of claim 18,
wherein said device is formed from a biodegradable material.
21. The implantable tissue approximation device of claim 18,
wherein said soft tissue anchor portion defines a through-hole.
22. The implantable tissue approximation device of claim 21,
wherein said through-hole is slotted.
23. A method of approximating soft tissue to bone tissue using an
approximation device having a soft tissue anchor portion and a bone
tissue anchor portion, comprising: engaging a plurality of
projections on the soft tissue anchor portion with the soft tissue;
engaging the bone tissue anchor portion with the bone tissue; and
approximating the soft tissue to the bone tissue using a coupling
portion between the bone tissue anchor portion and the soft tissue
anchor portion.
24. The method of claim 23, wherein engaging the bone tissue anchor
portion with the bone tissue occurs before engaging the plurality
of projections with the soft tissue.
25. A method of approximating first and second soft tissue areas
using an approximation device having first and second soft tissue
anchor portions each including a plurality of projections and being
separated by a coupling portion, comprising: engaging the plurality
of projections of the first soft tissue anchor portion with the
first soft tissue area; engaging the plurality of projections of
the second soft tissue anchor portion with the second soft tissue
area; approximating the first and second soft tissue areas using
the coupling portion.
26. The method of claim 25, wherein the coupling portion is without
projections.
27. The method of claim 25, wherein the projections comprise burrs.
Description
[0001] The present application is a continuation of U.S. Ser. No.
09/969,947, filed on Oct. 3, 2001, now pending, which is a
continuation-in-part of PCT Serial No. PCT/US99/24098 filed on Oct.
18, 1999, now expired, which is a continuation-in-part of U.S. Ser.
No. 08/928,866, filed on Sep. 12, 1997, now U.S. Pat. No.
6,083,244, which is based on provisional patent application Serial
No. 60/026,101, filed Sep. 13, 1996, now abandoned, and provisional
patent application Serial No. 60/043,086, filed on Apr. 8, 1997,
now abandoned. The disclosures of each of these prior related
applications are hereby fully incorporated by reference herein.
FIELD OF THE INVENTION
[0002] The present invention generally relates to tendon or
ligament repair apparatus and methods. More specifically, the
invention relates to the repair of severed or otherwise damaged
tendons or ligaments and the attachment of tendons or ligaments to
bone. As used herein, the terms "tendon" and "ligament" are used in
a generally interchangeable manner.
BACKGROUND OF THE INVENTION
[0003] The repair of tendons or ligaments is a challenging and
complication prone area of surgery. As one example, the dilemma in
flexor tendon repair surgery in the hand is to adequately connect a
severed tendon without compromising the functionality of the hand
due to surgical intervention and repair techniques. Over the past
40 years, there have been only improvements in the basic suture
techniques to repair tendons. In order to make any substantial
improvement in the art of repairing a severed tendon one must first
understand the composition and structure of tendons and
ligaments.
[0004] Tendons can sustain high tensile forces resulting from
muscle contraction, yet are flexible enough to bend around bony
surfaces and deflect beneath retinacula to change the final
direction of muscle pull. Tendons attach muscle to bone and
transmit tensile loads from muscle to bone thereby producing joint
movement. Ligaments attach bone to bone and can flex to allow
natural movement of the bones that they attach, but are strong and
inextensible so as to offer suitable resistance to applied forces.
Ligaments augment the mechanical stability of the joints. The
biomechanical behavior of tendons and ligaments is viscoelastic or
rate dependent, that is, their strength and stiffness increase with
an increased loading rate. Bundles of collagen fibers embedded in a
connecting matrix, known as ground substance, provide the load
carrying elements of natural tendons and ligaments. The arrangement
of the collagen fibers is nearly parallel in tendons, equipping
them to withstand high unidirectional loads. The less parallel
arrangement of the collagen fibers in ligaments allows these
structures to sustain predominant tensile stresses in one direction
and smaller stresses in other directions. The ground substance in
both tendons and ligaments acts generally as a cementing matrix
holding the collagen fibers together. The ground substance retains
large amounts of water essential to the non-compressive hydraulic
function of the moving tissue. Also included in the tendon
composition are elastic fibers, tenocytes, small blood vessels and
nerves. In general, the cellular material (fibroblasts) occupies
about 20% to 38% depending on references, of the total tissue
volume, while the ground substance matrix accounts for the
remaining 62% to 80%. About 70% of the ground substance matrix
consists of water absorbed in an open polysaccharide matrix.
[0005] Two types of tendons exist in the hand for connecting
phalanx (finger) bones to the appropriate muscles. Flexor tendons,
which are connected to the volar or palm side of the fingers, lend
the ability to curl the fingers towards the palm. Extensor tendons,
which are connected to the dorsal or backside of the fingers,
return the curled fingers back into a straight position. Sheaths
and retinacula restrain most tendons in the hand to some extent and
keep them close to the skeletal plane so that they maintain a
relatively constant moment arm rather than bowstringing across the
joints. The pulley system of the flexor tendon sheath in the finger
is the most highly developed of these restraints. The flexor tendon
sheath pulley system permits the flexor tendons to maintain a
relatively constant moment arm and helps minimize stress risers
between tendon and sheath. This system serves three important
functions. First, it allows smooth tendon gliding or lubrication;
second, the retinacular reinforcing pulleys maintain the flexor
tendons close to the surface of the finger bones, preventing
bowstringing; and third, it provides an enclosed synovial fluid
environment for tendon nutrition and lubrication. As the finger
moves, each tendon slides a certain distance, which defines the
"excursion of the tendon". Excursion takes place simultaneously in
the flexor and extensor tendons during joint motion. The tendons of
the agonist, or contracting muscle, displace in one direction. The
tendons of the antagonist or resisting muscles displace in the
opposite direction to accommodate the motion.
[0006] Today, the most common methods of repairing torn, severed or
otherwise damaged tendons involve approximating the severed ends of
the tendons and suturing one side of the tendon to the other
thereby returning the tendon to its natural position. A popular
suture technique is the so-called Kessler technique and slight
modifications thereof. Some of the other techniques include the
Becker, Savage, lateral trap, double loop locking suture,
four-strand interlock and variations of the Halsted technique.
Other methods place prosthetic material either within or around the
tendon. Polyester strips and sleeves along with polyester mesh have
been used to reinforce the suture/tendon interface to provide a
stronger repair.
[0007] After flexor tendon repair, resistance to tendon gliding
increases at the repair site. Repair techniques that use an
increased number of suture strands, or increased amounts of suture
material or prosthetic material promote greater glide resistance.
In particular, adhesions form due to the tendon's natural response
to healing, i.e., the ingrowth of cells and vessels from
surrounding connective tissue. Current literature suggests
adhesions may constitute an inflammatory process at the site of
repair and an extension of the intrinsic tendon healing process to
the surrounding tissue.
[0008] An ideal repair would exhibit high strength, flexibility,
and a joining of the tendon ends without any foreign material on
the outside surface of the tendon. Physical therapy should begin
immediately after the repair to prevent the tendon from adhering to
the tendon sheath creating adhesions that limit the full excursion
of the tendon in its sheath. For this reason, the repair site must
withstand the immediate tensile stress being applied to it during
physical therapy. In a relaxed state, a flexor tendon experiences
about one pound of constant tension. When a person applies a light
grip, such as by grasping a key, about three to four pounds of
tensile force is applied to the tendon. A strong grip can apply
over ten pounds of tensile force to a tendon.
[0009] Since most suture-based tendon repairs reach their tensile
limit at about 6 lbs., surgeons must balance the desire to have
full and immediate active motion to prevent adhesions against the
need for immobilization to prevent rupture of the repair. Earlier
loading of a repaired tendon promotes a more rapid increase in
repair strength. For a tendon to properly rejoin, the opposed
tendon ends do not have to touch but they do need to be
approximated within 1-2 mm of each other to properly reattach. An
ideal tendon repair would hold the lacerated tendons together to
begin healing and tissue generation but slowly release tension
allowing the tendon to become the primary load bearing structure.
Tendons will heal at a rate that is proportional to the load being
applied during physical therapy.
[0010] Another major problem is the softening of the damaged tendon
ends, which begins shortly after the damage or injury occurs and
continues for approximately the next twelve days. This softening
results in a weakening of the tendon fibers, which contributes to
the formation of a gap at the repair site during the early phases
of tendon healing. It is believed that gaps form at the site of
repair due to a loss of purchase by the grasping portion of the
suture at the tendon-suture interface. The grasping suture may even
completely tear out, resulting in a failure of repair. A term for
this failure is "rake-out". Rake-out is a failure mode associated
with suture tendon repair in which the end of the severed tendon
has weakened and the suture tends to pull out of the tendon ends.
This splits the tendon and results in an undesirable gap or total
failure. Another common type of suture repair failure is of a
suture knot.
[0011] The effectiveness of a suture depends on many factors, such
as the suture material, the technique with which the suture is
inserted, and knot strength. Immediately after a tendon is
repaired, the strength of the repair depends almost entirely on the
suture technique. The ideal suture knot should terminate securely,
be strong, easy to handle and inelastic. The suture material used
today is generally braided polyester or a monofilament
polypropylene. Using current suture techniques, absorbable suture
materials do not have enough residual tensile strength over time to
resist gapping and rupturing. The ideal suture technique should be
easy to use, minimize interference with tendon vascularity and be
completely internal to the tendon without increasing the bulk of
the tendon. Locating the knots outside the tendon rather than
within the repair site may result in higher ultimate tensile
strength but will also increase the risk of adhesions and increase
the friction through the pulleys. This latter characteristic is
known as "work of flexion".
[0012] Most suture methods employ an internal suture with external
knots distal and proximal to the laceration or within the
laceration. The surgeon typically uses a continuous running
external suture at the junction of the repair, known as an
epitendinous suture, to approximate the tendon ends. The use of the
epitendinous suture increases the tensile strength of the repair
and helps to resist gapping, but it can also increase the risk of
adhesions and is difficult to master and very tedious to execute.
The evolution of tendon repair with sutures starts with the
two-strand technique. Some of the variations of this technique are
the Bunnell, Kessler, and Tsuge methods. When two-strand repairs
fail, the failure usually occurs at the knots. Studies have shown
that the initial strength of these repairs is proportional to the
number of suture strands that cross the repair site. This has led
to a trend of doubling, tripling, and even quadrupling the number
of strands placed across the repair site. With these multiple
strand techniques, Savage, Becker and Ketchum have shown
significant tensile strength over the two-strand methods but they
are more difficult to perform and add material to the outside
surface of the tendon with more exposed knots. These techniques
focus primarily on the increased effect on tensile strength and
disregard the increased resistance to the tendon gliding through
the pulleys. Therefore, the quest continues for the ideal suture
technique having the tensile strength required to allow the patient
to start physical therapy immediately, and having the low profile
necessary to minimize adhesions that compromise the ability of the
tendon to glide through the pulleys.
[0013] Techniques have also been developed that incorporate an
internal or external prosthetic splint. Low porosity woven
polyester, which is the same material used for aortic graft repair,
is being used as an artificial splint. There are basically two
methods of splint repair. The internal splint technique is
accomplished by placing a horizontal slit transversely in each
tendon stump proximal and distal to the laceration site. A
rectangular piece of polyester splint is placed into this slit on
both sides of the tendon. Sutures are then placed perpendicular to
the graft along each tendon thereby attaching the splint to the
tendon. The sutures attach the splint, which is basically a
flexible tensile member, to the interior surface of the tendon.
These suture knots are then tied on the outside of the tendon for
ease of placement and an epitendinous suture is placed at the
junction of the repair. As previously mentioned, the external knots
will increase the risk for adhesions and also increase the work of
flexion. The material of the tendon splint is inert and similar to
the suture material being used in other techniques and its internal
position within the substance of the tendon should promote tissue
ingrowth and enhance the repair site. However, the large slits in
the tendon ends might structurally damage the internal blood supply
of the tendon and cause tissue degeneration.
[0014] In the external splint technique, also known as the dorsal
tendon splint technique, the surgeon aligns both tendon ends and
places a two-strand Savage type core suture on the anterior surface
of the tendon. The surgeon then places a rectangular Dacron.RTM.
splint on the dorsal surface of the tendon across the laceration
site and sutures it to both tendon ends. In this technique, and as
mentioned earlier, the splint acts as a flexible tensile member
that prevents the tendons from gapping and rupturing during early
movement. As with the internal method, the knots are placed on the
exterior surface of the tendons and the splint is actually on the
outside surface. This will increase the risk of adhesions and
consequently increase the work of flexion. The internal tendon
splint may add too much bulk to the repair site, and the external
tendon splint may interfere with tendon gliding. Preliminary work
of flexion studies suggest both tendon splints increase the work of
flexion by 16-19%.
[0015] Another splint-type technique being used today is a
Dacron.RTM. or Prolene.RTM. mesh sleeve that surrounds the tendons.
The two ends of the lacerated tendons are placed in the proximal
and distal openings of the sleeve. The tendon ends are butted
together without any additional sutures, except that an
epitendinous suture is placed thereby attaching the sleeve to the
outside surfaces of the tendons. This is done on both ends of the
sleeve. This technique is 117% stronger in tension than a
conventional two-strand core stitch technique with an epitendinous
suture on the external surface. Like the aforementioned splint
techniques, these are tested in vitro (outside of the body) and do
not take into account any of the in vivo (inside the body) problems
that occur such as placing a significant amount of repair material
external to the tendon and within the tendon sheath. Again,
external repair material provides a potential source of fibrous
adhesions and an increase in work of flexion.
[0016] Implanted anchors have also been used to attach two ends of
a severed tendon. This type of anchor is similar to a Dacron.RTM.
splint in concept but is usually fabricated from stainless steel or
titanium. The geometry of the anchor also differentiates the anchor
from a splint. The anchor, which may measure 20 mm in length, 3 mm
in width and 1 mm in thickness, has a symmetrical double barbed end
configuration. The anchor is placed into the severed end of the
tendon by making a small transverse incision. Once the anchor is in
the correct depth the surgeon will place a suture through the
tendon at the flat side of the barb and knot the suture into a loop
thereby preventing the barb from being pulled out of the tendon.
The tendon will be sutured at each flat on the barb, providing two
suture loops per tendon end. The same suture technique is performed
on both ends thereby re-attaching the severed tendon. This repair
technique shows an increase in mean ultimate tensile strength of
49-240% over traditional two-strand and multi-strand suture
techniques. This technique is relatively easy to perform but it
does not address the in vivo problems caused by placing the suture
knots on the outside of the tendon. Here, they become a potential
source of fibrous adhesions and increase the work of flexion. This
type of tendon anchor can limit motion or cause pain when
positioned directly over a joint with the finger in maximal flexion
since it is long and fairly rigid. Also, the surgeon must still
bring the tendon ends together with a separate surgical tool and,
in the process, risk damaging the tendon ends.
[0017] Adhesives have been evaluated in the search for the ideal
tendon repair. Studies have been conducted using adhesives of the
cyanoacrylate group, more commonly known as super glues. These
adhesives form a strong adhesive bond with most human tissue,
particularly those containing a large amount of protein, such as
skin and tendon tissue, because they polymerize in the presence of
water and hydroxyl groups, both of which are abundantly present in
tendon tissue, and they do not require a solvent. They are known to
be biodegradable, although the time taken to degrade in tendons is
unknown and only the long chain varieties are known to be minimally
toxic to human tissue. The application of adhesives in tendon
repair is in conjunction with two-strand or multi-strand core
suture with an epitendinous suture. The adhesive is placed on the
tendon ends after the sutures have been placed and approximated to
allow for polymerization. The shortcomings that were discussed in
connection with suture repair are experienced with adhesive
techniques as well. Some problems with adhesives include their
potential non-biodegradability within the tendon, their
questionable effect on tendon healing, and their potential local
and systemic toxicity. Currently, therefore, adhesives do not
provide an adequate solution to tendon repair problems.
[0018] Current and past tendon or ligament repair techniques
concentrate on increasing the tensile strength of the repair by
adding more structural components to the repair, e.g., sleeves,
splints, additional suture strands, additional knots and adhesive.
All of these techniques trade off between early tensile strength,
increased work of flexion, and increased risk of adhesions or other
problems. While the surgeon debates the clinical technique, the
patient may suffer from a less than desirable outcome and
discomfort over the life of the repair. Adhesions cause pain and
limit motion of the affected joints. By increasing bulk to the
tendon, motion may be further limited and this can result in a
defect called "trigger finger."
[0019] None of these techniques have utilized the physiological
makeup of the tendon to provide a stronger repair. The tensile
strength of the tendon is provided by the lengthwise parallel
collagen fibers, which give it the ability to withstand high
tensile loads. The ground substance is made up primarily of water
and cannot be used to provide strength to the repair. The tendon
sheath is also too weak to provide meaningful assistance with
holding the two tendon ends together.
[0020] Similar problems arise when attaching tendons or ligaments
to bone. That is, simply suturing the tendon or ligament to a bone
anchor or using external tendon anchor members may not provide the
necessary strength of repair. As further discussed above, these
techniques also promote adhesion formation.
[0021] Finally, tendon retrieval has also been a problematic
portion of tendon repair surgery. Typically, the surgeon must use a
small grasping tool with thin, movable jaws similar to needle-nose
pliers to grasp a tendon end and pull and transfix it in an
appropriate operating position. Unfortunately, gripping the tendon
ends in this manner often damages them and makes the tissue less
able to hold the epitendinous suture. The damaged tendon ends will
also form scar tissue or adhesions which further adversely affect
the repair.
[0022] Therefore, there is a need for tendon repair techniques and
apparatus that harness the intrinsic strength of the tendon fibers,
but allow the tendon to flex while moving through the sheath. This
repair apparatus should resist any gapping or rupture during
immediate post-operative physical therapy, and reside in the
interior of the tendon to reduce or possibly eliminate
post-operative adhesions. The repair apparatus should also produce
low work of flexion while gliding unhindered through the tendon
sheaths. There is generally a need for tendon repair apparatus and
methods that allow the patient to immediately begin active physical
therapy without risking any tendon repair failure while minimizing
or eliminating the need for sutures or other repair structure on
the external surfaces of the tendon thereby reducing the occurrence
of adhesions and friction between the tendon repair and the sheath
pulley. There is a further need for tendon-to-bone repair
techniques and apparatus with at least some of these attributes.
Finally, there is a need for a tendon retrieval device which also
harnesses the inherent strength of the tendon fibers and minimizes
damage to the retrieved tendon end.
SUMMARY OF THE INVENTION
[0023] The present invention generally provides apparatus for
repairing damaged tendons or ligaments. The various repair
apparatus according to the invention employ an elongate tensile
member adapted to extend within the interior of the tendon or
ligament and various types of anchor structures configured for
insertion within the interior of the tendon or ligament. The anchor
structures are both movable along and lockable to the elongate
tensile member at a selected position. As some examples, these
anchor structures may comprise helical anchors with separately
connectable tendon fiber retaining members, unitary helical
anchor/tendon fiber retaining member assemblies, compressible
helical anchors, anchor bodies secured inside the tendon with
sutures or projections such as barbs, and crimp-type anchor members
that grip tendon fibers between two crimp portions or members, as
well as other configurations. Various embodiments of repair
apparatus are disclosed herein each serving to address the general
needs and drawbacks presented by the prior art as discussed
above.
[0024] Among the various advantages and objectives of this
invention, apparatus comprising at least one tendon or ligament
anchor structure in combination with an elongate tensile member are
provided and utilize the inherent strength of the bundles of
parallel collagen fibers in tendons or ligaments. Repair techniques
are provided that address the tensile component of the repair and
eliminate the increase of bulk to the tendon or ligament. This is
accomplished while reducing externally placed components that
compromise the ability of the tendon to glide through the pulleys.
Through an understanding and utilization of the inherent strength
provided by the bundles of parallel collagen fibers, the inventors
have developed anchor structures that grasp these high strength
fibers without constricting the blood flow to the tendon, and
without adding external bulk or additional knots. The anchor
systems of this invention further allow the patient to begin
immediate active motion physical therapy resulting in a quicker and
stronger tendon repair with fewer adhesions. Also, the combined
anchor structure and elongate tensile member of this invention
provide a tendon or ligament repair that can withstand greater
tensile loads than current and past repair techniques while
retaining the repaired tendon or ligament ends in a viable repair
position.
[0025] Generally stated, the present invention comprises at least
one anchor structure coupled for movement along the length of an
elongate tensile member. The anchor structure is lockable at a
desired location along the tensile member and generally includes
first and second fiber gripping portions configured for insertion
within the interior of a tendon or ligament. The gripping portions
may be on two separate components of the anchor structure or may be
portions of the same component. In several embodiments of the
invention, at least one of the fiber gripping portions is movable
with respect to the other to grip the fibers therebetween. Many
different configurations of anchor structures are disclosed herein
including single-piece anchor structures and multi-piece anchor
structures. In the single-piece anchor structures, one portion of a
member, such as a crimp member, is movable toward another portion
of the member to grip tendon fibers therebetween. In other
embodiments, separate pieces of the anchor structure are brought
together and locked to grip, engage or compress the tendon fibers
therebetween. In the most preferred embodiments, two anchor
structures are each initially movable along the length of the
elongate tensile member on opposite sides of a torn, lacerated or
otherwise damaged portion of the tendon. The anchor structures may
be locked to the fibers within the tendon and to the elongate
tensile member itself when the tendon is at the proper repair
position. Various more specific embodiments of the anchor
structures and elongate tensile members of this invention are
described hereinbelow.
[0026] In one embodiment of the invention, an anchor body in the
form of at least one helical anchor is configured for insertion
within the interior of the tendon or ligament. At least one
retaining member is coupled with the elongate tensile member and
provides a securing structure to hold the helical anchor to the
fibers extending within the interior of the tendon or ligament. In
a preferred apparatus of this type, first and second helical
anchors are provided with respective first and second retaining
members each being couplable for movement along the elongate
tensile member on opposite sides of a repair site. The retaining
members may each include, for example, an axial hole to allow this
movement. Optionally, a lengthwise slot may be provided in the
retaining member. In this embodiment, and the other embodiments of
the invention, the elongate tensile member may comprise a rigid,
semi-rigid or flexible member, including flexible sutures formed
from absorbable or non-absorbable materials, as well as tensile
members formed from various biocompatible metals, plastics,
ceramics, etc. The helical anchor preferably comprises a helically
wound coil which may be of constant or variable diameter and may be
formed of biocompatible metal. Optionally, the coil may be formed
from absorbable material or other non-absorbable biocompatible
materials. The retaining member is preferably configured to be
received within a corresponding helical anchor for compressing the
fibers between the retaining member and the helical anchor. When
the helical anchor is rotated into the tendon or ligament, fibers
of the tendon or ligament will be captured within the coils of the
anchor. When the retaining member is then inserted and affixed
within the helical anchor, the outer surface of the retaining
member compresses the fibers against inner surfaces of the helical
coils. Preferably, locking structure in the form of at least one
locking member is used for holding the retaining member to the
elongate tensile member at a desired position. This locking member
may be a separate slidably adjustable member or an integral portion
of the corresponding retaining member and may, for example,
comprise a deformable or crimpable portion of the retaining member
or a separate crimp member.
[0027] The retaining member or members preferably have associated
retaining structure either integrated therein or used as separate
structure for gripping the tendon fibers against the helical
anchor. For example, the retaining structure may comprise a
discontinuous surface adapted to aid in holding the fibers between
the retaining member and the helical anchor. As examples, this
discontinuous surface may be an exterior serrated surface, a
generally threaded surface, or another type of convoluted or
discontinuous surface. This surface may also serve to prevent the
retaining member from backing out of the helical anchor.
[0028] As another feature, the elongate tensile member and the
respective retaining member or members may include respective
engageable portions, such as ratchet-like portions, for holding the
retaining member at the desired position along the elongate tensile
member.
[0029] As still another feature, at least one of the elongate
tensile member, the first helical anchor and the retaining member
may be comprised of an absorbable material. During the absorption
process, this will allow a gradual transfer of tensile load to the
repair site to aid in healing. More generally stated, at least one
component of the anchor system will be made from an absorbable
material, such as polyglycolic acid or polyglyconate. This will
allow for the tensile stress of the anchor system to be gradually
transferred from the anchor system to the tendon during the healing
of the tendon repair site. As revealed previously, the healing
response of the tendon is directly proportional to the amount of
tension being applied to the tendon. In other words, more tension
on the tendon results in a stronger repair. However, the initial
condition of the repaired tendon does not withstand any tensile
load. Therefore, a timed release of the tension being applied to
the tendon will result in a stronger repair. By making a key
component or components from an absorbable material, the repair
apparatus slowly transfers tension to the tendon until the
component(s) completely degrade and releases all the tension to the
tendon repair site.
[0030] As an additional feature of the invention, the retaining
members may include structure configured to directly engage the
helical anchor to prevent the retaining members from backing out of
the helical anchors after implantation. As one example, this may
include ratchet-type structure on the retaining member adapted to
engage the trailing end of the helical anchor.
[0031] The retaining members of the various embodiments of this
invention may also have various configurations. One configuration
is a helical retaining member. In this case, the helical anchor
will be either received within the helical retaining member or may
receive the helical retaining member. Either construction forms
inner and outer helical members. This is helpful because the
helical members will compress tendon or ligament fibers
therebetween in a generally sinusoidal pattern. At least one of the
inner and outer helical members is collapsed or expanded toward the
other to clamp or compress the tendon or ligament fibers
therebetween. This may be accomplished, for example, through
mechanical spring action of the helical members during insertion or
through the use of electromagnetic impulse deformation. In the
latter case, and as detailed further below, one helical member may
be formed of a magnetic material while the other is not. Upon the
application of one or more impulses of electromagnetic energy, the
magnetic helical member will collapse onto the nonmagnetic helical
member compressing the tendon fibers therebetween.
[0032] As another option, the helical anchor of this invention may
be formed from a flexible suture material. In this case, the
retaining member is adapted to be inserted into the tendon or
ligament and the flexible suture material is then wrapped generally
helically about the retaining member to hold the tendon or ligament
fibers therebetween. As the flexible suture material which is
wrapped around the retaining member is not held in significant
tension, it may be formed of material having lower tensile strength
than the elongate tensile member.
[0033] In another embodiment of the invention, the apparatus may
comprise first and second helical anchors integrally formed from a
wire with the elongate tensile member extending therebetween. In
this embodiment, the anchors are helically wound in opposite
directions such that rotation of the integral apparatus in a single
direction, with the elongate tensile member disposed generally
between the damaged or severed tendon ends, will cause rotation of
each respective helical member into a respective tendon end.
Retaining members in accordance with the invention may then be used
to grip, compress or otherwise engage the tendon fibers to the
helical anchors.
[0034] In yet another embodiment of the invention, the apparatus
may include a helically coiled, compressible anchor configured for
insertion within the interior of the tendon or ligament and
couplable with the elongate tensile member. This compressible
anchor traps the fibers of the tendon or ligament between the coils
as its coils are moved from their uncompressed state to their
compressed state. As with the other embodiments of this invention,
the apparatus preferably includes a second anchor structure in the
form of another helically coiled, compressible anchor which is also
couplable to the elongate tensile member. It should also be noted
that the elongate tensile member of this invention may be formed by
two or more separate tensile members, such as sutures, which are
then tied or otherwise directly or indirectly affixed together
during the repair procedure such that a unitary elongate tensile
member is formed connecting at least two anchors together to hold
the tendon or ligament in an approximated repair position. In other
words, the elongate tensile member may be formed from a number of
different segments or portions which are ultimately secured
together and secured to the anchor structures. In the embodiment
employing compressible anchors, these anchors are also preferably
coupled for movement along the elongate tensile member and include
respective locking members, preferably slidably coupled to the
elongate tensile member, and adapted to hold the compressible
anchors at desired locations on the elongate tensile member. The
locking members may be, for example, formed as crimp members or
other structures formed integrally or separately from the
corresponding compressible anchor.
[0035] The retaining members of this invention may also be slotted
members. In a general sense, this allows the retaining member to be
coupled to the elongate tensile member without necessarily using a
sliding motion along the tensile member as with a retaining member
that includes an axial hole. The slot or slots may further act as a
collet structure configured to clamp onto the elongate tensile
member upon insertion into the helical anchor or through the use of
a separate tool. In another advantageous embodiment of a collet
structure, the retaining member may be a two-piece slotted collet
structure with an interior piece and an exterior piece. Upon
insertion of the exterior piece into the helical anchor and the
interior piece into the exterior piece, the interior piece is
configured to clamp onto the elongate tensile member and the
exterior piece is configured to expand within the helical anchor to
compress the fibers against the helical anchor.
[0036] In yet another embodiment, the elongate tensile member will
be locked to the helical anchor by trapping the elongate tensile
member between the internal retaining member and the helical
anchor. This will eliminate the need to have a locking feature
built into the internal retaining member in order to lock the
elongate tensile member to the helical anchor.
[0037] In yet another embodiment, the tendon repair apparatus has
multiple helical anchors. In this embodiment, there is more than
one helical anchor placed within the tendon. The helical anchors
may be wound in opposite directions and/or intertwined together.
This configuration is based on the aforementioned method of
grasping parallel collagen fibers. An advantage to multiple anchors
is that the amount of collagen fibers being trapped is directly
proportional to the amount of coils on the helical anchor.
Increasing the length and the number of coils of the helical anchor
likewise increases the amount of trapped collagen fiber. Since
there are limitations to the length of the anchor, an additional
anchor of the same length is placed in the tendon.
[0038] Another more specific anchor structure of this invention
utilizes a crimp-type anchor member. In this embodiment, one of the
fiber gripping portions further comprises at least one first
deformable portion adapted to be crimped within the tendon or
ligament to grip the fibers. In one specific embodiment, the crimp
member will have opposed legs that may be deformed toward one
another and onto the tendon fibers. The crimp member may further
include a second deformable portion configured to be crimped onto
the elongate tensile member to retain the crimp member at a desired
location thereon. In a related embodiment, the anchor structure may
further comprise first and second separate crimp members adapted to
be crimped onto the fibers generally from opposite sides of the
elongate tensile member. The first and second crimp members can
each include a respective plurality of deformable legs configured
to interlock after crimping to securely hold the first and second
crimp members to the tendon fibers. The first and second crimp
members can further include respective crimp portions configured to
be crimped onto the elongate tensile member to retain the first and
second crimp members at a desired location along the length of the
tensile member. As one other alternative, a separate locking member
may be used to retain the first and second crimp members at a
desired position along the length of the elongate tensile
member.
[0039] In another aspect, the anchor structures further comprise
first and second anchor bodies with respective first and second
securing structures. These securing structures may, for example,
comprise projections extending respectively from the first and
second anchor bodies that retain the anchor bodies within the
tendon or ligament. The anchor bodies may be tubular-shaped members
or members having various other shapes configured for insertion
within the tendon or ligament. As another alternative or additional
securing structure, the anchor bodies may include portions for
receiving sutures used to secure the first and second anchor bodies
within the interior of the tendon or ligament. As with the previous
embodiments, the locking structure can, for example, include a
crimpable or swageable member or an integral portion of an anchor
body operable to affix the anchor body onto the elongate tensile
member. In many of the embodiments of this invention, two anchor
bodies are each initially connected for movement along the elongate
tensile member and first and second respective locking structures
or members are used to lock each anchor body to the elongate
tensile member with the tendon or ligament in a desired repair
position.
[0040] As a further aspect, the invention provides apparatus for
affixing a tendon or ligament to a bone. In this embodiment, the
apparatus includes an elongate tensile member, a tendon or ligament
anchor structure constructed in accordance with any of the anchor
structures of this invention, and a bone anchor. The elongate
tensile member, for example, may be a flexible suture adapted to
extend within the interior of the tendon or ligament. The bone
anchor is coupled with the elongate tensile member and is
configured to be retained within the bone. As a more specific
feature of the preferred embodiment of this invention, the tendon
or ligament anchor may be a helical anchor as generally described
above and may be compressible. A retaining member is adapted to be
retained at a selected position along the elongate tensile member
to hold the bone anchor, elongate tensile member and helical anchor
together with the tendon or ligament against the bone. The
retaining member and the bone anchor may include cooperating
locking portions for connecting the retaining member and bone
anchor together with the helical anchor held generally
therebetween. Alternatively, or in addition, the retaining member
may be sized and configured to be received at least partially
within the helical anchor and a locking member, such as a crimp,
may be coupled with the elongate tensile member to hold the
retaining member at a desired position. As with the other
embodiments of this invention, the locking member may be, for
example, a deformable and slidable crimp member either separately
formed or integrally formed with the retaining member.
[0041] In another aspect of the present invention, a tendon or
ligament retrieval device is provided and operates to move a tendon
or ligament end to a desired operating position. The device
generally comprises an elongate body, a helical member coupled with
the elongate body and at least one drive mechanism coupled with the
helical member for effecting rotational movement of the helical
member into the tendon or ligament and subsequent translational
movement of the helical member to move the tendon or ligament to
the desired operating position. To facilitate this function, the
helical member is mounted for rotational and translational movement
relative to the elongate body. The elongate body is adapted to be
inserted into a tendon sheath, for example, and is preferably
flexible to allow manipulation therein by the surgeon. The elongate
body may also include a distal tip with anti-rotation structure for
engaging the tendon or ligament end and preventing rotation thereof
as the helical member rotates into the tendon or ligament end. As
one optional anti-rotation feature, the helical member may further
include first and second, counter-rotating helical grasping bodies
each being connected for rotation and translation by the drive
mechanism.
[0042] Various methods are also contemplated in accordance with the
invention relative to tendon or ligament repair. A representative
method involves installing an elongate tensile member within the
tendon or ligament and driving a first helical member into the
tendon or ligament. The first helical anchor is secured to the
elongate tensile member and a second helical anchor is driven into
the tendon or ligament. The tendon or ligament is then moved to a
repair position at least prior to securing the second helical
anchor to the elongate tensile member whereupon the second helical
anchor is then securely fastened to the elongate tensile member to
hold the tendon or ligament in the repair position. The various
tendon or ligament anchor structures disclosed herein may be used
for carrying out the repair methods and additional repair methods
will become more apparent upon review of the detailed description
of this invention.
[0043] In another embodiment of the invention, a helical anchor is
coupled to a tendon fiber retaining member to form a unitary anchor
assembly. The anchor and attached retaining member are driven into
the tendon or ligament at one time. This aspect of the invention
further includes an insertion tool for driving the assembly into
the tendon or ligament preferably with a simultaneous rotating and
translating movement. More specifically, the anchor assembly
comprises a core portion or retaining member positioned inside of a
helical anchor with the distal end of the anchor preferably being
tapered or sharpened to ease insertion and also extending distally
outward of a distal end of the retaining member. The distal end of
the retaining member may also be tapered and the outer surface can
include a helical groove or generally helically configured surface
which generally corresponds with the helical anchor. At the
proximal end of the retaining member, a slot is provided and the
proximal end of the anchor resides in the slot and is secured in a
suitable manner, such as through laser or resistence welding. The
extreme proximal end of the core portion or retaining member
includes tool engagement structure, such as a slot, which allows
the insertion tool to be used to rotate and translate the assembly
into the tendon or ligament. The core portion or retaining member
includes a central bore through which the elongate tensile member
extends and, in the preferred manner of making and using this
embodiment, a separate crimp member is secured to the tensile
member at the proximal end of the core portion or retaining member.
However, integral crimp members or other types of locking members
may be used instead. The seperate crimp member of this embodiment
has an annular groove in its outer surface to reduce the force
necessary to collapse the crimp on the elongate tensile member.
[0044] A unique crimp tool is provided with a jaw configuration
which both collapses the crimp, when desired, and which retains the
crimp between the jaws prior to use, such as during packaging,
shipping, and storage. For this latter purpose as well, a flexible
or frangible bar is coupled between two handles of the crimp tool
and aids in holding the jaws in a closed position to retain the
crimp therein prior to use, but also prevent the jaws from moving
together and prematurely collapsing the crimp until necessary
during surgery. The bar or bars may be formed of a suitable
material, such as plastic, which will bend or fracture during use.
The jaws also include a projection on one jaw and a recess in an
opposing jaw for receiving the crimp member. During use, the
projection is forced against the crimp member to collapse the crimp
member against the tensile member. The recess includes a ridge for
registering in the annular groove of the crimp member and thereby
assisting to hold the crimp member therein.
[0045] The method of using the unitary anchor assembly generally
corresponds to the broader aspects of the methods disclosed herein.
In a more specific and preferred method of using the embodiment of
this invention which comprises a unitary helical anchor and tendon
fiber retaining member, an anchor assembly is driven into the
tendon or ligament on each side of the damaged or lacerated area.
An elongate tensile member having a needle at one end and a preset
crimp member at an opposite end is then threaded through the
proximal end of a first one of the anchor assemblies and into the
space between the ends of the damaged tendon or ligament. A second
capturing member, such as a vena-puncture or syringe needle is then
inserted through the proximal end of the second anchor assembly and
into the space between the damaged or lacerated tendon or ligament
ends. The needle coupled to the elongate tensile member is then
captured, such as by inserting its end into the syringe needle, and
the elongate tensile member is pulled through the second anchor
assembly. A crimp member is then threaded onto the elongate tensile
member to a position abutting the proximal end of the second anchor
assembly and the tendon or ligament ends are pulled together to the
desired position. The crimp member is then deformed or collapsed
onto the tensile member to fix the tensile member and two anchor
assemblies at the desired length. The excess length of the tensile
member is then cut at the proximal end of the second anchor
assembly and any necessary additional closing procedures are
performed by the surgeon.
[0046] As one additional aspect of the invention, a removal tool is
provided which is especially useful for the latter embodiment and
comprises a rotatable tool having a pointed needle projecting from
a tool driver head. The tool driver head is configured to engage
the tool engagement structure on the proximal end of the unitary
anchor assembly and, in the preferred embodiment, comprises a
generally conventionally-shaped screwdriver projection
complementary to a slot in the proximal end of the anchor assembly.
It will be understood that many types of tool engagement structure
may be used for this purpose.
[0047] Various additional features, advantages and objectives of
the invention will become more readily apparent to those of
ordinary skill in the art upon review of the following detailed
description of the preferred embodiments, taken in conjunction with
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] FIG. 1 is a perspective sectional view of the bone repair
device according to the present invention;
[0049] FIG. 2 is a side view of the suture to be used with the bone
repair device according to the present invention;
[0050] FIG. 3 is a sectional view of the suture in place in a bone
to be repaired in accordance with the present invention;
[0051] FIG. 4 is a sectional view of a fractured bone repaired with
the bone repair device according to the present invention;
[0052] FIG. 5 is a sectional view of a first embodiment of a button
to be used with the bone repair device of the present
invention;
[0053] FIG. 6 is a sectional view of a second embodiment of a
button to be used with the bone repair device of the present
invention;
[0054] FIG. 7 is a top view of a third embodiment of a button to be
used with the bone repair device of the present invention;
[0055] FIG. 8 is a side view of a third embodiment of a button to
be used with the bone repair device of the present invention;
[0056] FIG. 9 is a sectional view of the third embodiment of a
button to be used with the bone repair device of the present
invention being attached to a suture;
[0057] FIG. 10 is a sectional view of a fourth embodiment of a
button to be used with the bone repair device of the present
invention being attached to a suture;
[0058] FIG. 11 is a perspective view of the bone repair device of
the present invention being used to repair a torn or fractured
meniscus;
[0059] FIG. 12 is a top view of the incisions made in a hand in the
prior art to repair a torn tendon;
[0060] FIG. 13 is a top view of the incisions made in accordance
with the present invention to repair a torn tendon;
[0061] FIG. 14 is a sectional view of a tendon being repaired in
accordance with the present invention;
[0062] FIG. 15 is a sectional view of a tendon being repaired using
a first embodiment of a button;
[0063] FIG. 15A is a cross-sectional view of a first embodiment of
a button as shown in FIG. 15;
[0064] FIG. 15B is a cross-sectional view of a second embodiment of
a button as shown in FIG. 15;
[0065] FIG. 15C is a cross-sectional view of a third embodiment of
a button as shown in FIG. 15;
[0066] FIG. 15D is a cross-sectional view of a Fourth embodiment of
a button as shown in FIG. 15;
[0067] FIG. 16 is a sectional view of a repaired tendon using a
first embodiment of a button in accordance with the present
invention;
[0068] FIG. 16A is a sectional view of a revised stitching
procedure in accordance with the invention of FIG. 15;
[0069] FIG. 17 is a sectional view of a repaired tendon using a
second embodiment of a button in accordance with the present
invention;
[0070] FIG. 17A is a sectional view of a second embodiment of a
button in accordance with the present invention being swaged to a
suture;
[0071] FIG. 17B is a top view of a second embodiment of a button in
accordance with the present invention;
[0072] FIG. 18A is a sectional view of a step in repair of a tendon
using a second embodiment of a suture in connection with the second
embodiment of the button;
[0073] FIG. 18B is a sectional view of a step in repair of a tendon
using a second embodiment of a suture in connection with the second
embodiment of the button;
[0074] FIG. 18C is a sectional view of a step in repair of a tendon
using a second embodiment of a suture in connection with the second
embodiment of the button;
[0075] FIG. 18D is a sectional view of a step in repair of a tendon
using a second embodiment of a suture in connection with the second
embodiment of the present invention;
[0076] FIG. 19 is a sectional view of a repaired tendon using a
third embodiment of the present invention;
[0077] FIG. 19A is a sectional view of the button of FIG. 19;
[0078] FIG. 20A is a sectional view of a step in the repair of a
tendon using a fourth embodiment of the present invention;
[0079] FIG. 20B is a sectional view of a repaired tendon using the
fourth embodiment of the present invention;
[0080] FIG. 21 is a sectional view of a tendon repair device in
accordance with the present invention used in connection with a
bone anchor;
[0081] FIG. 22 is a sectional view of a second tendon repair device
in accordance with the present invention used in connection with a
bone anchor;
[0082] FIG. 23A is a sectional view illustrating an alternative
embodiment of a tendon-to-bone repair apparatus in exploded
form;
[0083] FIG. 23B is a sectional view similar to FIG. 23A, but
showing the apparatus in assembled form attaching the tendon to the
bone;
[0084] FIG. 23C is an enlarged sectional view of the apparatus as
shown in FIG. 23B, specifically illustrating the compression of
tendon fibers within a helical anchor of the present invention;
[0085] FIG. 24A is a sectional view of another alternative
tendon-to-bone repair apparatus shown in exploded form;
[0086] FIG. 24B is a sectional view similar to FIG. 24A, but
showing the apparatus in assembled form;
[0087] FIG. 24C is an enlarged sectional view of the apparatus
shown in FIG. 24B;
[0088] FIG. 25A is a perspective view showing another alternative
tendon-to-bone repair apparatus in exploded form;
[0089] FIG. 25B is a sectional view of another tendon-to-bone
repair apparatus;
[0090] FIG. 26 is a sectional view illustrating yet another
alternative tendon-to-bone repair apparatus also including a
helical anchor system according to the invention;
[0091] FIG. 27 is a top view showing incisions made in a finger to
access a tendon in accordance with additional aspects of the
invention;
[0092] FIG. 28 is a top view similar to FIG. 27, but isolating the
finger to be repaired and showing transfixation of the tendon
segments;
[0093] FIG. 29 is a perspective, schematic view showing initial
steps in a tendon repair procedure in accordance with the
invention;
[0094] FIG. 30 is an enlarged perspective view of the distal end of
the tool shown in FIG. 29, illustrating the attachment of a helical
anchor in accordance with the invention;
[0095] FIG. 31 is a perspective view showing the insertion of the
helical anchor within a tendon segment;
[0096] FIG. 31A is a partially cross sectioned, perspective view
illustrating a modified form of the anchor insertion tool shown in
FIGS. 29-31;
[0097] FIG. 32 is a perspective view similar to FIG. 31, but
showing the subsequent insertion of a retaining member into the
tendon segment;
[0098] FIG. 33 is a partially fragmented sectional view similar to
FIG. 32, but showing the locking of the retaining member to the
elongate tensile member;
[0099] FIG. 34 is a sectional view taken along line 34-34 of FIG.
33;
[0100] FIG. 34A is a sectional view similar to FIG. 34, but
illustrating the locking portion of the retaining member in a
crimped or deformed condition;
[0101] FIG. 35 is a perspective view of the tendon repaired in
accordance with the invention;
[0102] FIG. 36 is an enlarged sectional view schematically
illustrating the attachment of a tendon repair apparatus of this
invention to the tendon fibers;
[0103] FIG. 37 is a plan view of an elongate tensile member,
helical anchor, and retaining member in accordance with another
embodiment of the invention;
[0104] FIG. 37A is a perspective view of another embodiment of a
helical anchor constructed in accordance with the invention;
[0105] FIG. 37B is an elevational view of repair apparatus
including the helical anchor of FIG. 37A and a retaining member
shown affixed to an elongate tensile member within a tendon in
accordance with the invention;
[0106] FIG. 38 is a partially sectioned plan view showing another
embodiment of a helical anchor system;
[0107] FIG. 39 is an enlarged partially sectioned view similar to
FIG. 38, but illustrating the partial absorption of the retaining
member in accordance with this embodiment;
[0108] FIG. 40 is a schematic, sectional view showing an
alternative configuration of a helical anchor;
[0109] FIG. 41 is a schematic, sectional view of another
alternative helical anchor;
[0110] FIG. 42 is a schematic, sectional view of another
alternative helical anchor;
[0111] FIG. 43 is a partially sectioned view of another alternative
repair apparatus connected within a tendon;
[0112] FIG. 44A is a partially sectioned view of another
alternative repair apparatus in accordance with the invention;
[0113] FIG. 44B is a partially sectioned view similar to FIG. 44A,
but showing the partial absorption of the retaining member of this
embodiment;
[0114] FIG. 45A is a partially sectioned view showing another
alternative embodiment of a repair apparatus in accordance with the
invention;
[0115] FIG. 45B is a partially sectioned view similar to FIG. 45A,
but showing partial absorption of the various components of the
apparatus;
[0116] FIG. 45C is a partially sectioned view similar to FIG. 45B,
but illustrating full absorption of the helical anchor and internal
retaining member and partial absorption of the elongate tensile
member;
[0117] FIG. 46 is a perspective view showing the partially
assembled condition of another alternative repair apparatus
employing a compressible helical anchor;
[0118] FIG. 47A is a perspective view of an alternative apparatus
employing a compressible helical anchor with an integrated locking
member;
[0119] FIG. 47B is a perspective view illustrating the embodiment
of FIG. 47A in a compressed and locked condition within a
tendon;
[0120] FIG. 48A is a partially sectioned view of an alternative
embodiment for a locking member used to retain a helical anchor at
a selected position along the elongate tensile member and showing
the locking member in an adjustable condition;
[0121] FIG. 48B is a partially sectioned view similar to FIG. 48A,
but showing the locking member in a locked condition;
[0122] FIG. 49A is a perspective view showing another alternative
tendon repair apparatus employing compressible, helical anchors in
accordance with the invention;
[0123] FIG. 49B is a perspective view similar to FIG. 49A, but
showing the apparatus fully implanted to repair the tendon;
[0124] FIG. 50 is a perspective view of another alternative
embodiment employing compressible, helical anchors in accordance
with the invention;
[0125] FIG. 51A is a partially sectioned view of another
alternative tendon repair apparatus employing electromagnetic
impulse energy to collapse one helical member onto another and
showing the uncollapsed condition;
[0126] FIG. 51B is a partially sectioned view similar to FIG. 51A,
but showing the collapsed condition of the outer helical member and
the attachment of a locking member within a tendon;
[0127] FIG. 51C is a partially sectioned view similar to FIG. 51B,
but illustrating an alternative embodiment having a solid or
non-helical inner retaining member;
[0128] FIG. 52 is a schematic, perspective view showing a magnetic
impulse generator operatively connected to a patient's finger for
generating the required electromagnetic impulse in the embodiments
of FIGS. 51A and 51B;
[0129] FIG. 53A is a schematic, perspective view showing another
alternative embodiment of a tendon repair apparatus employing a
collapsible helical member;
[0130] FIG. 53B is a schematic perspective view showing an
intermediate step in the application of the collapsible helical
member within the tendon;
[0131] FIG. 53C is a schematic perspective view similar to FIG.
53B, but showing a subsequent step with the collapsible helical
member being collapsed onto another helical member to compress
tendon fibers therebetween;
[0132] FIG. 54 is another alternative embodiment similar to the
embodiment of FIGS. 53A-53C, but schematically illustrating an
expandable helical member for trapping tendon fibers with another
helical member;
[0133] FIG. 55 is a fragmented plan view showing another tendon
repair apparatus employing a collet structure in accordance with
the invention;
[0134] FIG. 56 is a perspective view of another collet-type anchor
structure shown in exploded form;
[0135] FIG. 57 is a partially sectioned view of the embodiment
shown in FIG. 56, but illustrating the assembled condition of this
embodiment within a tendon;
[0136] FIG. 58 is a perspective view of another alternative helical
anchor and internal retaining member showing a ratchet structure
for preventing counter-rotation of the retaining member;
[0137] FIG. 59 is a perspective view of another embodiment
employing two helical members with interlocking or intermeshing
coils;
[0138] FIG. 60 is a perspective view of another alternative anchor
structure employing a flexible helical anchor wrapped around a
retaining member;
[0139] FIG. 61 is a graph illustrating a force/displacement curve
comparing a helical anchor repair apparatus of the invention
against a conventional Kessler repair technique;
[0140] FIG. 62 is a perspective view of another alternative
embodiment of the invention employing two helical anchors
integrated with an elongate tensile member;
[0141] FIG. 63 is a partially sectioned view of a tendon retrieval
device constructed in accordance with the invention;
[0142] FIG. 64 is a perspective view showing use of the retrieval
device of FIG. 63;
[0143] FIG. 65 is a perspective view illustrating an alternative
double helix embodiment useful in the tendon retrieval device of
this invention;
[0144] FIG. 66 is an end view taken along line 66-66 of FIG.
65;
[0145] FIG. 67 is a perspective view illustrating another
alternative anchor structure employing two crimpable anchor
members, and an elongate tensile member;
[0146] FIG. 68 is a perspective view of a portion of a tool used to
apply the anchor structure shown in FIG. 67;
[0147] FIG. 69 is a partially sectioned view illustrating the use
of the tool to crimp the anchor members onto a tendon and the
elongate tensile member;
[0148] FIG. 70 is a sectional view taken generally along line 70-70
of FIG. 67, but illustrating the crimped or deformed condition of
the crimp members on the tendon tissue;
[0149] FIG. 71 is a sectional view taken generally along line 71-71
of FIG. 67, but illustrating the crimped or deformed condition of
the crimp members locked onto the elongate tensile member;
[0150] FIG. 72 is a plan view illustrating an alternative
crimp-type anchor structure employing a single crimp member and
elongate tensile member;
[0151] FIG. 73 is a sectional view taken generally along line 73-73
of FIG. 72, but illustrating the crimped or deformed condition of
the crimp member onto the tendon tissue and around the elongate
tensile member;
[0152] FIG. 74 is a sectional view taken generally along line 74-74
of FIG. 72, but illustrating the crimped or deformed condition of
the crimp member onto the elongate tensile member;
[0153] FIG. 75 is a perspective view of a unitary anchor assembly
comprised of a helical anchor coupled for insertion with a core
portion or tendon fiber retaining member;
[0154] FIG. 76 is a plan view showing the unitary anchor assembly
of FIG. 75 carried on an elongate tensile member and including a
crimp member at a proximal end thereof;
[0155] FIG. 77 is a perspective view showing an insertion tool for
inserting the assembly of FIG. 75 into a tendon or ligament;
[0156] FIG. 78 is a cross sectional view generally taken along the
longitudinal axis of the insertion tool shown in FIG. 77;
[0157] FIG. 78A is an enlarged view, partially cross sectioned, of
the distal end of the tool shown in FIG. 78;
[0158] FIG. 79 is an enlarged cross sectional view of the tool
being used to drive the unitary anchor assembly into a tendon or
ligament;
[0159] FIG. 80 is a side elevational view schematically showing an
alternative pistol grip assembly for the insertion tool of FIG. 77
allowing one-handed operation by a surgeon;
[0160] FIG. 80A is a fragmented end view of the pistol grip
assembly of FIG. 80 schematically illustrating the interaction
between the rack and pinion drive;
[0161] FIGS. 81-87 are perspective views illustrating a tendon or
ligament repair method utilizing two unitary anchor assemblies and
an elongate, flexible tensile member;
[0162] FIG. 88 is an enlarged perspective view showing the jaw
portion of a crimp tool and a crimp member each constructed in
accordance with additional aspects of the invention.
[0163] FIG. 89 is a perspective view of an anchor assembly removal
tool in accordance with another aspect of the invention; and
[0164] FIG. 90 is an enlarged perspective view of the distal end of
the removal tool and the unitary anchor assembly of this
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0165] Bone and Meniscus Repair Device
[0166] As shown in FIGS. 1-10, a novel device 10 for repairing a
fractured bone 12 is shown. The fractured bone repair device 10 has
three primary parts, a flexible or rigid suture or filament 14, a
first button 16, and a second button 18. First button 16 is ideally
identical to second button 18. The suture or filament may be rigid
or flexible, monofilament or multifilament.
[0167] As shown most particularly in FIG. 2, suture 14 has a first
end 20 and a second end 22. First end 20 of suture 22 is made rigid
so as to allow the suture to be drilled through a fractured bone
12, as shown in FIG. 1. The rigid segment 20 is placed in a
standard driver (not shown) which is well-known to one of ordinary
skill in the art, most preferably a MicroAire Wire Driver. The
rigid segment 20 ideally has a sharp point 24 to allow for easier
drilling.
[0168] A sheath 26 may also be provided for the filament 14 during
the drilling procedure and forms a part of this invention. The
sheath 26 would serve as an extension from the collet 28 of any of
the well-known drilling tools. Two forms are contemplated. The
first would use a collapsing sheath (not shown), such as an
accordion pleat such that the sheath will buckle as the tool moves
towards the bone 12. alternatively, a concentric spring 30 may be
made of any of a variety of materials. The material must be strong
enough to withstand any punctures from small bone fragments which
may be displaced through the drilling procedure. However, it must
be thin enough to allow its collapse as drilling progresses. The
material must also have sufficient heat resistance or a
sufficiently high melting point that it is unaffected by the heat
generated by the drill. The sheath 16 will extend the full length
of the drilling tool from the collet 28 to fully protect
surrounding tissues.
[0169] Optionally a short pin is located on the second end 22 of
the suture 14. This pin 32 may be used for hand drilling the bone
12. whether the bone 12 must be hand-drilled or may be drilled by
machine is based on a number of factors, all of which are
well-known by these of ordinary skill in the art. The filament may
alternately be passed through a pre-drilled hole in the bone
12.
[0170] Regardless of how the bone 12 is drilled, the method of
operation of the bone repair device 10 is the same. The rigid
second end 22 is drilled from a first side 34 of a fracture 36 to a
second side 38 of fracture 36. The rigid second end 22 is then
pulled such that the suture portion 14 is within the bone 12. The
purpose of the suture 14 being optionally flexible is that many
bones which are fractured are small in size and are not easily
aligned. In order to properly repair a bone, most particularly a
small bone, using prior art technology, a practitioner must spend a
large amount of time precisely aligning the first side 34 and
second side 38 of fracture 36. If the suture used is flexible, the
first side 34 and second side 38 need not be precisely aligned,
since the flexible suture 14 can bend at any point. While it is
desirable that first side 34 and second side 38 be somewhat
aligned, it is not necessary to have as great a precision and much
time can be saved.
[0171] The suture 14 is preferably a monofilament or multifilament
wire or flexible polymer. The thickness of suture 14 depends on the
size and location of the bone but, for small bones such as are in
the hand, will fall within the range of 0.02 to 0.06 inches in
diameter. The differing tensile strengths which will be needed for
various bones and the tensile strengths of various thicknesses are
well-known to one of ordinary skill in the art.
[0172] Once the suture 14 has been drilled through bone 12, or
passed through a pre-drilled hole, it extends completely through
bone 12 from the first side 34 of fracture 36 to the second side 38
of fracture 36. The suture 14 must then be secured in order to hold
the first side 34 and second side 38 together until fracture 36 is
healed. The suture is secured on each side 34, 36 by a button 16,
18. Because each button 16, 18 is selected from the same group of
possible designs, the designs are described only in reference to
first button 16. However, it will be understood that second button
18 may have a similar design.
[0173] As is most clearly shown in FIGS. 5 and 6, two types of
buttons 16 are preferred. FIG. 5 shows a button 16 which includes a
flange 40 which extends to or beneath the surface 44 of bone 12.
FIG. 6 shows a button 16 which includes a flange 42 resting on the
surface 44 of bone 12. Flanges 40, 42 serve to aid in distributing
the tension load from the suture 14. Each button 16 has an inner
surface 46, 48 which slidably contacts and circumscribes suture 14.
On the inner surfaces 46, 48 of the buttons 16 is one or more
notches 50, 52. Notch 50 is formed such that it is an extension of
flange 40, whereas notch 52 is formed separately of flange 42.
Because suture 14 is flexible and somewhat soft, compared to
buttons 16, a crimping tool (not shown) may be used to press
inwardly on or crimp button 16 such that notches 50, 52 penetrate
suture 14 and become secured to suture 14. In this way, the buttons
16, 18 may become attached to suture 14.
[0174] An alternative button 16 is shown in FIGS. 7-10. This button
16 is a locking spring washer. With such a button 16, the tension
on the suture 14 may be increased, but not decreased. This type of
button 16 locks by itself with no crimping tool required. The
suture 14 ideally includes notches or grooves 54 to aid in the
attachment of button 16 to suture 14.
[0175] This method if ideally designed for use with bones in the
hands or feet which are smaller and more delicate. However, the
same invention may be used in connection with larger bones and may
be particularly useful if a larger bone is broken into many smaller
pieces. The diameter of the rigid segment, filament, and pin must
be adjusted to effectively join the bone and fragment, especially
if the bone and fragment are large.
[0176] Turning to FIG. 11, the same invention may also be used to
repair a torn meniscus 56. The suture 14 (shown in dashed lines) is
threaded through the meniscus 56 from a first side 58 to a second
side 60 of fracture or gear 62. While a meniscus 56 is typically
referred to as being torn rather than fractured, the word
"fracture" and all forms thereof should be understood to refer to
both bones and to menisci in the context of this invention for ease
of understanding and vocabulary and to avoid confusion with the
invention (described below) which relates to the repair of torn
tendons. A first button 16 is attached to and circumscribes suture
14 on a first side 58 of the fracture 62 and a second button 18 is
attached to and circumscribes suture 14 on a second side 60 of
fracture 62. Buttons 16, 18 may have the same configuration as
those described above or may resemble the tabs 144 as described in
tendon repair, FIG. 17B.
[0177] Tendon Repair Device and Method
[0178] The method described may be used with any of the relevant
buttons in the present invention. The prior art method for
repairing a torn tendon is shown in FIG. 12, and involves making a
single long incision over the location of the torn tendon. The
present invention (shown in FIG. 13) uses a device and method for
repairing a torn tendon through one or more skin incisions and two
or more smaller incisions in the sheath, minimizing trauma to
critical tissues. This invention may be used to repair either a
tendon or a ligament. The term "tendon" as used in the application
should be understood to also encompass ligaments.
[0179] As shown in FIGS. 13 and 14, a surgeon makes a first
incision 100 in the skin 102 above the location of the tear 104 in
the tendon 106. It is noted that the skin above the tendon tear 104
may have already been incised as in a laceration. If such is the
case, only a small neatening of the incision may be relevant. The
surgeon then makes a second incision 108 on the first side 110 of
the first incision 100. The surgeon also makes a third incision 112
on the second side 114 of the first incision. These incisions 100,
108, 112 preferably involve several transverse incisions or short
"T" or "L" incisions. Additional small "window" incisions may be
necessary to gain access for retrieval of the tendon end. The
incisions 100, 108, 112 may also involve rolling the tendon or
ligament sheath down a distance of about 3 mm. A needle 116 (FIG.
14) is then threaded with a core suture or elongate tensile member
118. The needle 1167 is preferably a swaged, large radius,
non-cutting needle, which allows the needle 116 to penetrate the
filamentous tendon 106 without weakening it. For flexor tendons in
the hand, the suture 118 is preferably USP size No. 1 or No. 2 and
is preferably made of a monofilament of polyester, stainless steel,
or polyglactin 910, or other high strength material. The needle 116
and attached suture 118 are then inserted into the tendon at the
first side 112 of the tear 104. The needle 116 and the suture 118
travel down the center 120 of the tendon 106, exiting at the second
incisions 108. The surgeon then inserts needle 116 and attached
suture 118 at approximately the same center 120 of the second side
124 of tear 104. The needle 116 and attached suture 118 exit the
tendon 104 through the third incision 112 on the second side 114 of
the tear 104. The suture 118 is then tightened such that the first
side 122 of the tear 104 is drawn into abutting relationship to the
second side 124 of the tear 104, shown most clearly in FIG. 13. A
second suture 118 may also need to be inserted in a similar
fashion, as will become clear from the following description. Once
the suture 118 has been properly placed, it must be secured in
order to maintain the abutting relationship between first side 122
and second side 124 of tear 104.
[0180] A first way of securing the suture is with a variety of
buttons. A first embodiment is shown in FIG. 15 which shows the use
of a sliding anchor button or body 126. A surgeon makes a stab or
slit wound 128 in the tendon 106 in an area generally under the
second incision 108 made on the first side 110 of the first
incision 100. The sliding anchor button or body 126 slips onto the
suture 118 and into the stab wound 128 under the exterior surface
129 of tendon 106. The sliding anchor button 126 has burrs 130
which serve to assist in holding sliding anchor button 126 in place
in tendon 106 once it reaches the desired location. The burrs 130
are directed such that they are facing towards the tear 104 and
generally outwardly from the suture 118 and serve to reduce the
possible motion of sliding anchor button 126 and to distribute the
axial load. In order to properly place the sliding anchor button
126, a tool 132 should be used which is capable of keeping the
exterior surface of sliding anchor button 126 from coming into
contact with tendon 106 prior to its correct placement. The tool
132 is important, since otherwise, the burrs 130 can tear or
otherwise damage the tendon 106. Once the sliding anchor button 126
is in place, the tool 132 is retracted and sliding anchor button
126 is swaged to the suture 118 such that sliding anchor button 126
is attached to and at least partially circumscribes suture 118.
FIGS. 15A-15D show a variety of possible forms for the sliding
anchor button 126 in cross section. Each of these sliding anchor
buttons 126 has a width W. Preferably width W is about 2 mm. As can
be seen in these Figs., the sliding anchor button 126 can be
configured such that it slides onto suture 118 by being threaded,
as in FIGS. 15B-15D, or through a side slot as in FIG. 15A. Note
also that in these embodiments, the burrs 130 are directed radially
outwardly from the suture. Once the sliding anchor button 126 has
been placed and swaged onto suture 118, the stab wound 128 is
closed, preferably using a continuous microsuture. As can be seen
in FIG. 16A, the stitches used to close the stab wound 128 may also
penetrate to sliding anchor button 126 and to optional holes 133.
Once one sliding anchor button 126 has been placed, a surgeon can
insert a second sliding anchor button in the same way on the second
side 114 of the first incision 100 below the third incision 112.
During the installation of the second button 126, the abutting
relationship between first side 122 and second side 124 of tear 104
is assured by pre-tensioning the core suture 118 as the second
button 126 is attached. Tension may be applied by a special aspect
of tool 132 or by manual means. The remainder of the procedure is
the same as that mentioned above. Once a button has been inserted
on each of first side 110 and second side 114, the tendon appears
as is shown in FIG. 16. The incisions 100, 108, 112 may then be
closed in any fashion known in the art.
[0181] A second embodiment of securing buttons is shown in FIG. 17.
In FIG. 17, two sutures 118 are used to hold first side 122 and
second side 124 in abutting relationship, as was mentioned above.
In such a case, a first suture 118 must be placed to one side of
the center 120 of tendon 106 and a second suture 118 must be placed
to another side of the center 120 of tendon 106. If this embodiment
is used, no stab wound need be made in the tendon 106. In this
embodiment, once the suture is placed, the tab buttons 136 slide
onto suture 118 until they reach the exterior surface 129. The
suture 118 may be placed under greater tension by pushing tab
buttons 136 such that they place some pressure on the exterior
surface 138 of tendon 106. Once the tab buttons 136 have been
appropriately placed, they are swaged or crimped to suture 118 such
that they are attached to and circumscribe at least a part of
suture 118, as shown most clearly in FIG. 17A, by a swaging tool
140. Preferably, as shown in FIG. 17B, the tab button 136 has a
circular shape, and includes a central portion 142 and a circular
flange 144. The central portion 142 and flange 144 include a slot
146 which allows tab button 136 to be easily placed on suture 118.
When tab button 136 is in place, the flange 144 extends radially
outwardly of the suture 118, shown most clearly in FIG. 17. The tab
button 136 may include burrs 148 which extend generally outwardly
from the suture 118 and serve to keep the tab buttons 136 in place
and distribute the axial load. Once the first tab button 136 has
been placed, a second, third, and fourth tab button 136 may be
similarly placed using a similar method for each suture 118.
[0182] The tab button 136 may also be used with a different
embodiment of the suture, as shown in FIGS. 18A-18D. In this
embodiment, a split and monofilament 150 is used. The split end
suture 150 is inserted in the center 120 of first side 122 of
tendon 106, as shown by the direction of the arrow in FIG. 18A. The
split end suture 150 has a first end 152. The first end 152 of
split end suture 150 is divided into a first part 154 and a second
part 156. When split end suture 150 is inserted into tendon 106,
the first part 154 and second part 156 are contained within a cap
158 to retain first part 154 and second part 156 together. Cap 158
has a sharp end 160 to allow cap 158 to penetrate tendon 106. After
the split end suture 150 and cap 158 reach an appropriate depth,
the split end suture 150 is withdrawn in the direction of the arrow
shown in FIG. 18B. The split end suture 150 is withdrawn only to
just beyond the cap 158. The split end suture 150 is then pushed in
an inward direction as noted by the arrow in FIG. 18C. When the
split end suture 150 is pushed, the first part 154 and second part
156 split apart and eventually break the exterior surface 138 of
tendon 106. A fifth and sixth tab button 136 are then attached to
the first part 154 and second part 156, respectively, such that
fifth and sixth tab buttons 136 are attached to and at least
partially circumscribe the first part 154 and second part 156,
respectively. The same operation would apply on the second end (not
shown) of the split end suture 150, which is substantially the same
as the first end 152 of split end suture 150. The second end would
simply be inserted into the second side 124 of tear 104. Other
considerations which would be relevant are that the split end
suture 150 should ideally be inserted such that half of it extends
into each of first side 122 and second side 124, and the first side
122 and second side 124 must be held in an abutting relationship,
so that the entire length of the split end suture 150 should be
within the tendon 106. The tab buttons 136 used with the split end
suture 150 are the same as those mentioned earlier and may include
flanges 144 or burrs 148.
[0183] Turning now to FIG. 19, a third embodiment of buttons is
shown. The transverse button 162 is again used in conjunction with
two sutures 118, inserted as described above. The transverse button
162, as shown in FIG. 19A, is attached to an partially
circumscribes a first suture 118 and is swaged or crimped onto the
first suture 118 with a swaging tool, such as tool 140. Another
transverse button 162 is attached to and partially circumscribes a
second suture 118 and is swaged or crimped onto the second suture
118 with a swaging tool, such as tool 140. In this embodiment, the
transverse buttons 162 are attached to each other by a telescoping
mating pin 164. Attached to one of the transverse buttons 162 is
the male portion 166 of the pin 164, and attached to the other
transverse button 162 is the female portion 168 of the pin 164. The
male portion 166 and the female portion 168 are pushed towards each
other through tendon 106. When male portion 166 and female portion
168 reach each other, they ratchet and lock, thereby causing one of
the transverse buttons 162 to be attached to the other transverse
button 162.
[0184] The second method of securing the suture, instead of using
buttons, is by using the suture itself. Turning to FIGS. 20A and
20B, the suture 170 includes barbs 172, which serve to secure the
suture 170 and distribute the axial load. When the barbed sutures
170 are inserted into tendon 106 as described above, the sutures
must be completely surrounded by a cannula 174 or other protective
device which serves to keep barbs 172 from become attached to
tendon 106 prior to proper placement. Once suture 170 is properly
placed, as shown in FIG. 20A, cannula 174 is removed in any
standard way. The barbs 172 will then keep the suture 170 in place
and keep first side 122 and second side 124 of tear 104 in abutting
relationship.
[0185] An alternative installation process may be used in this
invention where a single suture has a needle on each end. In which
case the needles enter the central wound opening and each
penetrates the severed end of the tendon; the two needles moving in
opposite directions to exit at one of the window openings spaced
from the wound. After each needle exits the suture is tightened and
the tendon ends are drawn together by the structure and procedural
steps described above.
[0186] Device for Securing a Torn Tendon to a Bone
[0187] This invention relates to the use of a button as described
above in connection with a known bone anchor in order to secure a
tendon to a bone. Turning first to FIG. 21, a system is shown for
attaching a bone 200 and a tendon or ligament 202. A bone anchor
204 is installed in a hole 205 in the bone 200. Any of the standard
bone anchors known in the art are suitable, as long as they are
capable of being attached to a flexible suture 206. As shown in
FIG. 21, a sliding anchor button 208 is attached to the flexible
suture 206 and at least partially circumscribes the flexible suture
206. The sliding anchor button shown in connection with the bone
anchor 204 is inserted as was described earlier in connection with
the tendon repair device under the surface 210 of the tendon
202.
[0188] Turning now to FIG. 22, a second embodiment of the
tendon-bone anchor is disclosed. This embodiment is most preferably
used when the tendon has a relatively thin cross-section, such as
for exterior tendons and most ligaments. Again, bone anchor 204 is
installed in a hole 205 in the bone 200. Any of the standard bone
anchors known in the art are suitable, as long as they are capable
of being attached to a flexible suture 206. Also attached to the
flexible suture 206 is a tab button 212, which includes barbs 214
extending generally parallel with flexible suture 206 and radially
outward on flange 211. Tab button 212 is attached to suture 206 as
was described above such that tab button 212 is attached to and at
least partially circumscribes suture 206.
[0189] Another embodiment of a tendon to bone repair apparatus 250
is shown in FIGS. 23A-23C. In this embodiment, apparatus 250
includes an elongate tensile member 252 connected at one end with a
bone anchor 254, such as by a knot or other stop member 252a. Bone
anchor 254 may be a conventional bone anchor configured for
retainment within a bone 256. Apparatus 250 further includes a
helical, compressible anchor 258 which has been rotated into a
tendon or ligament 260. A retaining member 262, which may simply
comprise a small button in this embodiment, receives elongate
tensile member 252, which may be a strong suture, and slides down
onto tendon 260 as shown in FIG. 23B. A locking member, which may
be a crimp member 264 receives elongate tensile member 252 and
slides down on top of retaining member 262 where upon it is
deformed or crimped and locked onto elongate tensile member 252 to
hold apparatus 250 together with a portion of tendon 260 held
firmly against bone anchor 254. As further detailed in FIG. 23C,
the compressible, helical anchor 258, which may have the tapered
configuration as shown or other configurations as detailed herein,
traps fiber 266 of tendon 260 in a generally sinusoid pattern
between respective coils of anchor 258.
[0190] Another embodiment of a tendon to bone repair apparatus 270
is shown in FIGS. 24A-24C. Apparatus 270 also comprises an elongate
tensile member 272 connected with a bone anchor 274 again by way of
a suitable stop, knot or other method. Bone anchor 274 is fixedly
secured within a bone 276. A helical anchor 278 is rotated into a
tendon or ligament 280 and is compressible. Unlike the previous
embodiment, however, anchor 278 is inserted generally with its axis
in line with the length of tendon or ligament 280 and anchor 278 is
compressible generally along its length, as shown in FIG. 24B. When
a retaining member 282 is received on elongate tensile member 272
and compressed onto tendon 280, against bone anchor 274, this will
compress helical anchor 278 in a sideward manner as shown. A
locking member 284, which again may be a crimp member integral or
separate from retaining member 282, is then slid down elongate
tensile member against retaining member 282 to hold 20 apparatus
270 in the position shown in FIG. 24B. As shown in FIG. 24C,
elongate tensile member 272 extends through the center of helical
anchor 278 generally along the lengthwise axis thereof and from one
end to the other, although the helical anchor may intertwine with
the coils of anchor 274 in other manners as well. Fibers 286 of
tendon 280 will extend between the coils of anchor 274 in a
generally sinusoidal pattern thus firmly trapping anchor 274 within
tendon or ligament 280.
[0191] Another embodiment 290 is shown in FIG. 25A. Apparatus 290
comprises an elongate tensile member 292 suitable connected to a
bone anchor 294 by way of a knot or stop member 292a or another
method. Apparatus 290 further includes a helical anchor 298, which
again is preferably compressible, and received on elongate tensile
member 292. A retaining member 302 is also received on elongate
tensile member 292 as shown in FIG. 25A. Locking members, in the
form of projections 294a, 294b, 294c, are disposed on bone anchor
294 and register in receiving slots 302a, 302b, 302c within
retaining member 302. Apparatus 290 is used in a manner similar to
apparatus 250 shown in FIGS. 23A-23C, except that after helical
anchor 298 has been rotated into a tendon, retaining member 302 is
pushed or rotated simultaneously with helical anchor 298 if anchor
298 is attached to retaining member 302, and locked onto bone
anchor 294 through the receipt of projections 294, 294b, 294c
within the respective slots 302a, 302b, 302c. The insertion and
retainment of helical anchor 298 within a tendon or ligament may
advantageously occur in a single surgical step if helical anchor
298 is connected for rotation with retaining member 302. In this
case, for example, rotation of retaining member 302 can
simultaneously rotate helical anchor 298 into a tendon or ligament
and lock the assembly onto bone anchor 294.
[0192] Another embodiment of a tendon to bone repair apparatus 310
is shown in FIG. 25B. In apparatus 310, an elongate tensile member
312 is again connected with a bone anchor 314 by a suitable method,
such as a knot 312a. Bone anchor 314 is securely affixed, such as
by a threading action within a bone 316. A helical anchor 318 is
received on elongate tensile member 312 and is adapted to be
rotated into a tendon 320. Helical anchor 318 is connected to a
retaining member 322 in this embodiment either through a mechanical
or integral connection. A locking member 324, which again may
comprise a crimp member, is integrally formed with retaining member
322 in this alternative embodiment. In its attached configuration,
apparatus 310 is very similar to apparatus 250 shown in FIGS.
23A-23C with helical anchor 318 being trapped within tendon 320 and
fibers thereof being generally sinusoidally trapped between the
coils of anchor 318.
[0193] Another alternative tendon bone repair apparatus 330 is
shown in FIG. 26. Apparatus 330 includes an elongate tensile member
332 connected in a suitable rigid manner to bone anchor 334 such
that it may be placed into tension. Bone anchor 334 is again
affixed securely within a bone 336. A helical anchor 338 is rotated
into a tendon or ligament 340 in a manner similar to the
embodiment, for example, of FIGS. 23A-23C. In this embodiment,
however, a retaining member 322 is provided for at least partial
insertion within anchor 338 as shown in the assembled condition of
FIG. 26. This traps fibers between retaining member 342 and the
coils of anchor 338. Once retaining member 342 is securely received
within anchor 338, a locking member 344, which may be integral to
or separate from retaining member 342, is slid onto elongate
tensile member 332 against retaining member 342 and crimped onto
tensile member 332. It should be appreciated that, although the
elongate tensile members of the embodiments shown in FIGS. 23A-26
are flexible sutures, these may also be more rigid tensile members,
such as members made of biocompatible metals or they may
alternatively be formed of absorbable materials. One or more of the
other elements of these tendon to bone repair apparatus may also be
formed of absorbable materials.
[0194] Alternative Tendon Repair Apparatus
[0195] The invention contemplates further embodiments of
tendon-to-tendon or ligament-to-ligament repair apparatus. For
simplicity, only the term "tendon" is used herein at various
points. A review of the general procedure is appropriate with
reference first to FIGS. 27 and 28. When faced with repairing a
severed or otherwise damaged tendon, the surgeon must make an
incision to repair the severed or damaged tendon. FIG. 27 shows the
actual laceration site 350 of a finger 351 and the augmented
incision 352 made by the surgeon to gain access. After the incision
has been made the skin flaps 354 are reflected back for full
visualization of the damage. The surgeon will retrieve the proximal
tendon segment 356 of the damaged tendon through a triangular
window access incision 358 made in the tendon sheath 360. The
triangular incision 358 helps prevent the end of the proximal
tendon segment 356 from catching on window incision 358 as it is
retrieved. The distal segment 362 of the damaged tendon will also
be retrieved in the same manner. Once the tendons ends have been
retrieved as shown in FIG. 28, they are held in place temporarily
with transfixation needles 364. The function of these needles is to
hold the tendon segments 356, 362 together without damaging the
tips of the tendon which must be kept as trauma free as possible to
promote a good repair.
[0196] FIG. 29 shows the transfixed tendon ends 370, 372 without
the surrounding anatomy and transfixation needles 364. In
accordance with the invention, access incisions 374 of about 0.5 cm
in length is made approximately 2-3 cm from the lacerated ends 370,
372 of the tendon. Preferably, a No. 2 suture 376 is placed in
through the access incision 374 of the proximal tendon segment 356
out through the lacerated end 372 of the proximal segment 356 into
the lacerated end 370 of the distal tendon segment 362 and out
through the access incision 374 of the distal tendon segment 362.
Once the suture 376 is placed lengthwise through the tendon with a
needle 378, the surgeon places an anchor system of this invention
into the tendon body.
[0197] FIG. 31A illustrates an alternative tool 392' for rotating
helical anchor 390 into the tendon. Tool 392' includes a flexible,
hollow shaft 396', however, in this embodiment shaft 396' is
contained within a hollow sheath 397 which is also flexible.
Anti-rotation structure 399 is disposed within sheath 397 and may
be actuated between a retracted position within sheath and an
extended position as shown in FIG. 31A. In the illustrative example
shown, structure 399 comprises spikes that flare outwardly into
tendon segment 356 to prevent rotation of tendon segment 356 as
flexible shaft 396' is rotated, while sheath 397 remains
stationary. This prevents the tendency of the tendon from rotating
with the anchor as the anchor is rotated into place.
[0198] Referring now to FIGS. 29-31, a first alternative helical
anchor repair apparatus is shown being inserted into tendon
segments 356, 362. This includes a first helical anchor 390 being
applied with a tool 392 having a handle 394 and a flexible shaft
396. It will be appreciated that many different tool configurations
may be used in place of tool 392. A distal end of tool 392 includes
an anchor mounting portion 398 having a blunt tip. A trailing end
400 of helical anchor 390 includes a drive portion received in an
aperture 402 associated with a hub 404 of end portion 398. Anchor
390 further includes a leading end 406 which may be formed as
either a sharpened or blunt tip. Anchor mounting portion 398
further includes a suitable aperture (not shown) along its length
such that elongate tensile member or suture 376 may be threaded
therethrough as shown in FIG. 29. Thus, anchor 390 is releasably
attached to end portion 398 and elongate tensile member 376 extends
through the center of helical anchor 390.
[0199] Tool 392 is used to rotate helical anchor 390 like a screw
into tendon segment 356 through access incision 374 and rotated
into place as shown in FIG. 31. At this point, the surgeon pulls
back on tool 392 thereby releasing mounting end portion 398 from
helical anchor 390. At this point, and as shown in FIG. 32, a
retaining member 410 is installed at least partially within helical
anchor 390. An installation tool 412 is used to grasp retaining
member 410, which is slidably received on elongate tensile member
376. The surgeon slides retaining member 410 along elongate tensile
member or suture 376 until reaching the position shown in FIG. 33.
This traps and compresses the collagen fibers of the tendon between
retaining member 410 and helical anchor 390 in a manner to be
discussed further below. When retaining member is firmly situated
within helical anchor 390, the surgeon can deform a rear crimpable
portion 414 as depicted in FIGS. 33, 34 and 34A. In this regard,
FIG. 34 shows rear crimpable portion 414 in an uncrimped state,
while FIG. 34A shows crimpable portion 414 in a crimped position
securely affixed to elongate tensile member 376. This fixes the
anchor structure, comprising anchor 390 and retaining member 410
securely to the fibers within tendon segment 356 and also affixes
the anchor structure to the desired location on elongate tensile
member suture 376. Upon completion of this step, the surgeon moves
on to tendon segment 362 and applies a similar procedure to affix a
second helical anchor 420 and retaining member 422 to the suture
376 through access incision 374. Prior to crimping retaining member
422 onto suture 376, the surgeon may adjust the distance between
tendon ends 370, 372 by sliding the anchor structure 420, 422 along
suture 376 while applying a force, such as with tool 412, to move
the assembly 420, 422 along with tendon segment 362 toward the
opposite segment 356. When the desired repair position is reached,
for example, with tendon ends 370, 372 approximately 1-2 mm apart,
the surgeon crimps retaining member 422 to suture 376 in a manner
similar to FIG. 34A.
[0200] It will be understood that other manners of locking a
retaining member, such as members 410 and 422, in place may be used
instead of crimp members or deformable portions of the retaining
members. As shown in FIG. 35, opposite ends of suture 376 are cut
at locations close to the respective retaining members 410, 422 and
access incisions are closed, such as by using sutures 424, 426 or
another acceptable method. Finally, a running suture 428 is placed
at the junction of tendon ends 370, 372 or, again, another
acceptable connection method may be used.
[0201] FIG. 36 illustrates an alternative helical anchor 440 and
retaining member 442 connected to elongate tensile member or suture
376 and held within tendon segment 356. FIG. 36 further illustrates
the benefits of the invention in more detail. In this regard,
fibers 244, which extend lengthwise within tendon segment 356 have
been engaged within coils 446 of anchor 440 as anchor 440 was
rotated into place as previously described. This engagement will
occur generally in a sinusoidal pattern as shown, although the
number and density of fibers 444 has been drastically reduced in
the figure for clarity. Retaining member 442 may also have a
discontinuous outer surface 448, as shown, such as a serrated
surface as shown in cross section in this view. This will further
help retain the tendon fibers 444 between retaining member 442 and
helical anchor 440 and prevent retaining member 442 from backing
out of helical anchor 440. An integral crimp member 450 is disposed
on a trailing end of retaining member 442. A separate crimp member
or other locking structure may be used in its place.
[0202] FIG. 37 discloses another alternative embodiment including a
helical anchor 460 and a retaining member 462 adapted to be fixed
into place on elongate tensile member 376 in a manner generally
similar to the previous helical anchor embodiments. In this
embodiment, retaining member 462 includes a discontinuous outer
surface in the form of a threaded surface 464 which provides an
anti-backout function and will allow gripping of the tendon fibers
as retaining member 462 is rotated into helical anchor 460. A
crimp, member 466 may be provided to fix retaining member 462 in
place as previously described. Also, suitable flats 468 may be
provided for tool engagement allowing rotation of retaining member
462.
[0203] FIGS. 37A and 37B respectively illustrate another
alternative embodiment of a helical anchor 460' and an anchor
structure comprising a helical anchor and retaining member 460',
462'. Helical anchor 460' has opposite, tapering but blunt ends
460a', 460b' to allow insertion into a tendon at either end 460a'
and 460b'. The blunt ends 460a', 460b' will spread the tendon
tissue during entry as opposed to tearing, slicing or otherwise
damaging the tissue. Other sharpened or blunt end configurations
may be used as well. Retaining member 462' includes a slot 462a' at
a trailing end for engagement with a rotating tool, and a tapered
leading end 462b' for entry into helical anchor 460'. An outer
surface 462c' is discontinuous in a convoluted, generally helical
manner to generally register with the coils of helical anchor 460'.
Thus, fibers 444 will be retained during use in a generally
sinusoidal manner between the coils of helical anchor 460' and the
convoluted outer surface 462c' of retaining member 462'. Finally,
retaining member 462' includes a central aperture 463 along its
longitudinal axis for receiving an elongate tensile member such as
the previously described suture 376.
[0204] FIGS. 38 and 39 illustrate another alternative embodiment
utilizing a modified elongate tensile member 376' having barb or
ratchet structure 470. Ratchet structure 470 is engageable with an
internal portion 472 of a retaining member 474. Therefore, as
retaining member 474 is moved into helical anchor 460, the
interaction of structures 470 and 472 will prevent retaining member
474 from backing out. This therefore provides an alternative
locking structure for holding retaining member 474 against anchor
460 with tendon fibers trapped and compressed therebetween. As
further shown in FIG. 39, retaining member 474 may be formed from
absorbable material, such as polyglycolic acid or polyglyconate. As
retaining member 474 is absorbed, more tensile force will be
experienced at the repair site as retaining member 474 will tend to
move slightly further into helical anchor 460. This gradual
increase in tensile stress at the repair site will promote faster
and stronger healing.
[0205] FIGS. 40-42 illustrate three potential alternative
embodiments of helical anchors, namely, anchors 480, 482 and 484.
As currently contemplated, the anchors will be tapered from a
larger diameter at a trailing end to a smaller diameter at a
leading end to assist in threading the anchor into the tendon
tissue. However, it will be understood that many other
configurations are possible as well with a few of the possibilities
illustrated in FIGS. 40-42. In FIG. 40, helical anchor 480, shown
in cross section, has a varying diameter along its length and an
axis 486 which is not parallel to elongate tensile member 376
during use. Also, tensile member 376 travels partially within the
coils of anchor 480 and partially outside of the coils. In FIG. 41,
a similar configuration is shown, except that tensile member 376 is
contained entirely within helical anchor 482 and anchor 482 has
coils of approximately equal diameter along its length. FIG. 42
illustrates an anchor 484 that converges in diameter centrally from
each end.
[0206] FIG. 43 illustrates another embodiment of the invention
wherein the elongate tensile member 376 is retained by a wedging
action between a retaining member 490 and a helical anchor 492.
Retaining member 490 may have a serrated or otherwise discontinuous
outer surface 494 for assisting in wedging and retaining elongate
tensile member 376 against tendon fibers 496 and helical anchor
492. Again, the number and density of fibers 496 is drastically
reduced in FIG. 43 for clarity.
[0207] Another embodiment of the invention is shown in FIGS. 44A
and 44B. This embodiment is similar to the embodiment shown in FIG.
36 but illustrates the effect of forming retaining member 442' from
absorbable materials. The effect is similar to the effect described
above in connection with FIGS. 38 and 39. That is, as retaining
member 442' absorbs into the tendon, the repair site will
experience a greater amount of tensile force during physical
therapy or other motion of the tendon. Again, this will speed the
healing process and result in strengthening the repair site.
[0208] FIGS. 45A-45C illustrate a further use of absorbable
materials for helical anchor 440', retaining member 442' and
elongate tensile member 376". In this embodiment, each of the
elements will gradually absorb as shown progressively in the
figures such that the function of transferring more tensile stress
to the repair site is accomplished and such that the repair
apparatus as a whole will fully or substantially absorb into the
tendon after it has fulfilled its repair function. In this
embodiment, the absorption rates of the different components may be
varied by using different materials. For example, retaining member
442' may be formed to absorb faster than elongate tensile member
376" or anchor 440' such that tension is, at first, gradually
transferred to the repair site. Then, after full healing has taken
place, the remaining components can absorb into the tendon,
removing all tensile reinforcement from the repair.
[0209] FIG. 46 illustrates an alternative embodiment of the
invention comprising a compressible, helical anchor 500 receiving
elongate tensile member 376 and adapted to be retained in place
within a tendon through a compressing action brought about by a
suitable structure on elongate tensile member 376, such as a
separate crimp member 502 or an integral or attached crimp member
associated with helical anchor 500 as shown in FIGS. 47A and 47B.
It will be understood that many other potential locking structure
may be substituted for crimp members 502 and 504 as long as the
ultimate function of compressing helical anchor 500 is
accomplished. As shown in FIG. 47B, when crimp member 502 or 504 is
fixed onto elongate tensile member 376, an elongate tensile member
376 is pulled in the direction of arrow 506, toward the repair
site, the coils of helical anchor 500 will compress and securely
engage the tendon fibers therein. In this manner, helical anchor
500 will be locked onto tendon fibers 508 and the tendon segments
may be pulled together at the repair site in the manner described
above.
[0210] An alternative crimp member is shown in FIGS. 48A and 48B.
In this embodiment, crimp member 520 comprises first and second
movable portions 522, 524 connected at a central portion 526. Crimp
member 520 may be received on and slid along elongate tensile
member 376 in abutting relation to a trailing end portion 500a of
helical anchor 500 and crimped against elongate tensile member 376
by squeezing ends 528, 530 together as shown in FIG. 48B. A nub 532
and opposing recess 534 may be provided to help retain crimp member
520 fixed against elongate tensile member 376. Opposite ends 536,
538 may bear against trailing end portion 500a. In this manner, the
assembly may be used, for example, in the manner described with
respect to FIG. 47B.
[0211] An alternative embodiment of a repair apparatus 550
incorporating an elongate tensile member 552 and a pair of
compressible, helical anchors 554, 556 is shown in FIGS. 49A and
49B. In this embodiment, elongate tensile member 552 is initially
comprised of two suture segments 552a, 552b. As with the other
embodiments this may be USP No. 2 suture. As in the previous
embodiments, a crimp member 558, 560 may be associated with each
compressible, helical anchor 554, 556 or the respective tensile
member segments 552a, 552b may be connected with anchors 554, 556
in another suitable manner. The two tensile member segments 552a,
552b are threaded through a central crimp member 562 after being
introduced through respective tendon segments 564, 566 preferably
through respective proximal and distal windows in the tendon as
described above. Tensile member segments 552a, 552b are pulled taut
through central crimp member 562. This simultaneously compresses
helical anchors 554, 556 and pulls tendon segments 564, 566
together to a repair position as shown in FIG. 49B. At this time, a
conventional running suture 568, or optionally an adhesive or other
acceptable method, may be used to connect tendon segments 564, 566
together at the repair site.
[0212] Another embodiment of a tendon repair apparatus 570 is shown
in FIG. 50. Apparatus 570 utilizes an elongate tensile member 572,
such as a suture comprised of one suture segment looped through a
plurality of, for example, four compressible, helical anchors 574,
576, 578, 580. In this embodiment, separate crimp members at each
helical anchor may be eliminated as the suture itself will pull
each of the helical anchors 574, 576, 578, 580 to a compressed
position as the two suture ends 572a, 572b are pulled through
central crimp member 582. As in the embodiment of FIG. 49A and 49B,
pulling the two ends 572a, 572b through central crimp member 582
will simultaneously compress each helical anchor 574, 576, 578, 580
and bring tendon segments 584, 586 together to a repair position at
which points ends 572a, 572b may be cut and a running suture or
other final attachment method may be employed by the surgeon to
complete the repair.
[0213] FIGS. 51A, 51B and 52 illustrate an alternative manner of
employing helical anchors to connect a repair apparatus to tendons
and ligaments. Specifically, this system employs first and second
helical members 590, 592 with at least one of the helical members
590, 592 being movable toward the other to trap and compress tendon
or ligament fibers 594 of the tendon or ligament 596 therebetween.
As with other embodiments of the invention, a suitable locking
member, such as a crimp member 600, may be used to connect elongate
tensile member 598 for movement with anchor members 590, 592 such
that tendon segment 596 may be pulled and placed under tension with
elongate tensile member 598. In the specific embodiment shown in
FIGS. 51A, 51B and 52, a magnetic impulse generator 602 is
connected with a magnetic impulse supply unit 604 disposed around
the patient's finger 606. Analogous systems are available from
Maxwell Magneform.RTM. in San Diego, Calif. When a magnetic impulse
or impulses are supplied with generator 602 this will collapse
first helical member 590 onto second helical member 592. To
accomplish this, for example, first helical member or outer helical
member 590 may be formed from a magnetic metal material, while
second helical member or inner member 592 is formed from a
non-magnetic material and, therefore, does not deform through the
application of an electromagnetic impulse. As with several other
embodiments of this invention, this again employs the general
technique of providing two portions of a tendon or ligament anchor
structure with at least one portion being movable toward the other
portion to trap and compress tendon or ligament fibers
therebetween. Furthermore, prior to crimping of member 600, crimp
member 600 may be moved along elongate tensile member 598, after
collapsing outer helical member 590 such that tendon segment 596 is
moved to the appropriate repair position at which point the surgeon
may crimp member 600 to retain tendon segment 596 at the repair
position.
[0214] FIG. 51C illustrates another alternative embodiment similar
in concept to the embodiment of FIGS. 51A and 51B. In this
embodiment, however, an inner retaining member 462' can comprise a
solid core member, as opposed to a helical member. Retaining member
462' can be formed of absorbable or non-absorbable materials.
Retaining member 462' is preferably threaded over elongate tensile
member 598 after insertion of outer helical member 590 within
tendon 596. Initially, outer helical member 590 is in an
uncollapsed or expanded state, as shown in phantom lines, and
receives both elongate tensile member 598 and retaining member
462'. After insertion of retaining member 462', one or more
electromagnetic impulses are applied to collapse outer helical
member 590 generally to the position shown in solid lines thereby
compressing tendon fibers 594 between outer helical member 590 and
inner retaining member 462'. As further shown, retaining member
462' may include an outer discontinuous surface, such as a
convoluted or threaded surface 462c' to help retain, grip or
otherwise engage fibers 594. As necessary, a locking member 600'
may be crimped or otherwise locked onto elongate tensile member 598
and against retaining member 462' to lock the anchor structure,
comprising retaining member 462' and helical member 590, to
elongate tensile member. It will be appreciated that locking member
600' may not be necessary in any given application of the inventive
concepts.
[0215] FIGS. 53A-53C illustrate another alternative embodiment of a
repair apparatus 610 employing generally similar concepts to the
embodiment of FIGS. 51A and 51B. Specifically, in FIG. 53A,
apparatus 610 is employed in a tendon segment 612 and again
includes an elongate tensile member 614 connected with a first
helical member 616 by a suitable connector 618. A second helical
member 620 is initially contained in a hollow, helical carrier 622.
Carrier 622 has a diameter "D" which is greater than the diameter
"d" of second helical member 620. Thus, as second helical member
620 is rotated into carrier 622, member 620 elastically expands to
the shape of carrier 622 and is therefore initially disposed or
carried at a diameter "D'. As further shown in FIG. 53B, as carrier
622 and second helical member 620 are rotated into tendon segment
612 through an access incision 624, carrier 622 is rotated over
first helical member 616. As further shown in FIG. 53C, as carrier
622 is counter-rotated or rotated in a reverse direction, second
helical member 620 is left behind and resiliently contracts or
compresses around first helical member 616 thereby trapping tendon
fibers (not shown) between member 616 and member 620. It may be
necessary for the surgeon to hold second helical member 620
stationary while counter-rotating carrier 622 as shown in FIG. 53C.
Upon removal of carrier 622, elongate tensile member 614 will be
effectively connected to tendon segment 612 and may be placed under
tension while, for example, pulling tendon segment 612 to a repair
position as previously described.
[0216] FIG. 54 illustrates an alternative embodiment of an
apparatus 630 essentially employing a reverse technique as compared
to the embodiment of FIGS. 53A-53C. In this embodiment, a hollow,
helical carrier 632 has a smaller outer diameter "d", than the
respective diameters "D" associated with first and second helical
members 634, 636. Elongate tensile member 614 may be suitably
connected to first helical member 634, such as through the use of a
suture knot 614a. In this embodiment, first helical member 634 is
rotated into tendon segment 612 in one of the previously described
manners and, similarly, carrier 632, which contains second helical
member 636 in a resiliently compressed state is rotated into the
center of first helical member 634. With second helical member 636
held stationary, helical carrier 632 is counter-rotated, as shown
in FIG. 54, leaving second helical member 636 to resiliently expand
to its normal diameter "D" thereby trapping tendon fibers (not
shown) between first and second helical members 634, 636. With
carrier 632 removed, and helical members 634, 636 securely affixed
to the tendon fibers, elongate tensile member 614 may be placed
under tension and used to pull tendon segment 612 to a repair
position as previously described. It should be appreciated that the
respective diameters of helical members 616, 620 and 634, 636 may
vary within the same anchor system. That is, helical anchor 616 may
be slightly smaller or larger than helical anchor 620 and helical
anchor 634 may be slightly smaller or larger than helical anchor
636 while retaining the ability to trap tendon fibers therebetween.
Again, each of these anchor structures employ at least one moveable
anchor portion to trap fibers between itself and another anchor
member.
[0217] FIG. 55 illustrates another alternative apparatus 640
comprised of a helical anchor 642 and elongate tensile member 644
and a retaining member 646. These three elements operate together
similar to previous embodiments in that helical anchor 642 and
retaining members 646 are each initially slidable along elongate
tensile member 644. Elongate tensile member 644 may again be a
flexible suture, semi-flexible or rigid tensile member. In this
embodiment, retaining member 646 acts as a collet structure and
includes one or more slots 648 extending from a leading end 646a.
Also, retaining member 646 may include a discontinuous outer
surface 650, such as a surface having a generally threaded
configuration. It will be appreciated that, as retaining member 646
is rotated into helical anchor 642, tendon or ligament fibers (not
shown) will be trapped between surface 650 of retaining member 646
and the inner surfaces of helical anchor 642. At the same time, the
collet structure at the leading end of retaining member 646 will
compress due to the slot or slots 648 and will clamp against
elongate tensile member 644 to retain the assembly fixed on
elongate tensile member 644. Retaining member 646 may be formed of
a material that allows the leading end to plastically deform and
clamp onto elongate tensile member 644.
[0218] A related embodiment utilizing collet-like structure is
shown in FIGS. 56 and 57. In this embodiment, an apparatus 660
generally includes a helical anchor 662 and a two-piece retaining
member structure comprised of inner and outer retaining elements
664, 666. Anchor 662 and retaining elements 664, 666 are initially
slidable-along an elongate tensile member 668. One or more slots
670 are formed at a leading end of inner retaining element 664 and
one or more slots 672 are formed at a trailing end of outer
retaining element 666. Again, an outer surface 674 may be
discontinuous to help trap tendon fiber between outer retaining
element 666 and helical anchor 662 as described below. A review of
FIG. 57 will indicate the function of various elements shown in
FIG. 56. More particularly, after helical anchor 662 has been
rotated into a tendon segment 676, the surgeon slides inner
retaining element 664 into helical anchor 662 to trap tendon fiber
678 between outer surface 674 and helical anchor 662. To lock the
assembly into place and to expand outer retaining element 664 to
further lock the tendon fiber 678, the surgeon slides inner
retaining element 664 or, alternatively, rotates inner retaining
element 664 into outer retaining element 666. This simultaneously
expands outer retaining element 666 through the action of slots 672
and contracts the leading end of inner retaining element 664
through the action of slots 670 and a tapered inner surface 680 of
outer retaining element 666. Thus, in the position shown in FIG.
57, apparatus 660 is ready for use in accordance with the inventive
concepts to repair the tendon by placing tendon segment 676 into
tension using elongate tensile member 668.
[0219] FIG. 58 illustrates an alternative apparatus 690 again
employing a helical anchor member 692 and a retaining member 694
each connected for sliding movement along an elongate tensile
member 696. Retaining member 694 may again include a drive portion
698 for allowing retaining member 694 to be rotated into helical
anchor 692. This embodiment illustrates a manner of preventing
counter-rotation or backout of retaining member 694 after
installation within a tendon. In this regard, a ratchet structure
700 is disposed at a trailing end portion of retaining member 694
for engaging a trailing end 692a of helical anchor 692. As
retaining member 694 is rotated into helical anchor 692, ratchet
structure 700 will engage trailing end 692a to prevent
counter-rotation of retaining member 694.
[0220] FIG. 59 illustrates two helical anchors 702, 704 in which
the helical coils are interlocked or intertwined. This may be used
in the various embodiments of this invention to better interlock
the helical anchor structure with the tendon fibers. For example,
while one helical anchor 702 may be initially rotated into the
tendon and, subsequently, the second helical anchor 704 may be
rotated in an interlocking fashion with the first helical anchor
702. The assembly is then used in accordance with the invention,
and with one or more elongate tensile members or tensile member
segments to place a tendon under tension during a repair as
generally described herein. Alternatively, the coils of anchor 702,
704 may interlock in a lateral direction as shown in FIG. 59
without actually having the coils of one anchor rotate into the
coils of the other anchor.
[0221] FIG. 60 illustrates an alternative apparatus 710 in which a
flexible helical anchor 712 is wrapped around an internal retaining
member 714. Helical anchor 712 may be formed from suture material,
for example, that is one in the same with an elongate tensile
member 716 used in accordance with the inventive concepts or which
is separate from an elongate tensile member which may extend
through a central longitudinal aperture (not shown) within
retaining member 714. Leading and trailing hook members 718, 720
may be provided for guiding helical anchor 712 at the ends of
retaining member 714.
[0222] FIG. 61 illustrates force vs. displacement curves for
helical anchor apparatus of the present invention as compared to
conventional Kessler repair techniques. The helical anchor repair
apparatus represented in FIG. 61 corresponds with the embodiment of
FIG. 37B. The Kessler stitch techniques were performed with 3-0
Vicryl sutures and each repair was placed in porcine tendon of
approximately 5 mm diameter. The graph demonstrates that the
Kessler stitches allow displacement or gapping between the tendon
segments at low levels of tensile force as compared to the helical
anchor structures and elongate tensile member of the present
invention. In other words, the helical anchors of the present
invention will sustain much higher levels of tensile force without
significant amounts of gapping occurring between the tendon ends as
compared to the Kessler stitch technique. For this reason, a
patient who has undergone a repair using the present invention can
undergo more immediately and vigorous physical therapy than a
patient having a Kessler stitch repair. Ultimately, the patient
will experience a quicker recovery time and more mobility proximate
the repair site using the present invention.
[0223] FIG. 62 illustrates an alternative embodiment of the
invention wherein an integral apparatus 730 comprises a tensile
member 732 and opposite helical anchors 734, 736. Anchors 734, 736
are coiled in opposite directions such that rotation of apparatus
730 in a single direction will cause helical portions 734, 736 to
each rotate into respective opposed tendon segments 738, 740.
Apparatus 730 may be formed with various degrees of rigidity or
flexibility suitable for the repair site. Retaining members (not
shown) in accordance with the invention may be used to hold anchors
734, 736 securely to the tendon tissue.
[0224] The concepts employed in the helical anchor based repair
apparatus of the present invention may also be employed in a tendon
retrieval device 750 as, for example, shown in FIGS. 63 and 64.
Retrieval device 750 may be inserted into a tendon sheath through a
window 752, which may be triangular-shaped as previously described.
Retrieval device 750 more specifically comprises a rotatable shaft
or rod 754 having a helical retrieving member 756 at one end and a
rotatable knob 758 connected at an opposite end. Shaft or rod 754
is contained within a hollow inner core 760 which, in turn, is
contained within an outer core 762. Anti-rotation members 764, 766
are preferably provided within hollow outer core 762 and may be
actuated from non-operative positions to the operative positions
shown in FIG. 63. This is accomplished by reciprocating a knob 768
back and forth. When knob 768 is moved to the left, as viewed in
FIG. 63, this extends anti-rotation members 764, 766 into the
tendon sheath 770 to prevent rotation thereof as rotatable knob 758
is subsequently rotated and moved inwardly to rotate helical member
756 into tendon end 772. Once helical member 756 is fully rotated
into tendon end 772, knob 758 may be pulled to the right, as viewed
in FIG. 63, to retrieve tendon end 772.
[0225] It will be appreciated that retrieval device 750 may be
modified in many different manners consistent with the concepts
disclosed herein. As one example, device 750 may further include an
internal retaining member which may be inserted into helical member
756 to retain tendon fibers therebetween as previously discussed
above with respect to tendon-to-bone and tendon-to-tendon repair
apparatus. Another potential alternative is shown in FIGS. 65 and
66 in which inner and outer helical retrieving members 776, 778 are
employed to counter-rotate into tendon end 772. Suitable actuation
structure (not shown) will be employed to counter-rotate helical
members 776, 778, thereby eliminating tendon rotation while the
retrieval device is attaching to the tendon end 772.
[0226] FIGS. 67-71 illustrate another alternative embodiment of the
present invention employing analogous concepts to previous
embodiments wherein at least one portion of an anchor structure
moves with respect to another to a position at which tendon fibers
are trapped between the portions and the anchor structure is
affixed to an elongate tensile member. In particular, an apparatus
800 is shown and comprises a pair of anchor members 802, 804 which
may be crimped together and simultaneously crimped within a tendon
806 and securely against an elongate tensile member 808, such as a
suture or other tensile member as described above. Each anchor
member 802, 804 includes respective long legs 810 and respective
short legs 812 that register together in alternating fashion when
in opposed relation as shown in FIG. 67 and as shown being applied
through opposite access incisions 814, 816 in FIG. 69.
[0227] FIGS. 68 and 69 illustrate a tool 820 having a pair of
movable jaws 822, 824 used to apply anchor members 802, 804 to
tendon 806. Jaws 822, 824 include respective grippers 826, 828 for
holding anchor members 802, 804 in opposed relation as shown in
FIG. 69. As further detailed in FIG. 68, each jaw 822, 824 includes
pockets 830 that align with the ends of the legs 810, 812 of the
opposed anchor member 802 or 804. A clip 832, or other structure,
may be provided to retain anchor member 802 and 804 in place until
the crimping operation is complete. As shown in FIGS. 70 and 71, as
jaws 822, 824 and grippers 826, 828 are brought together from the
position shown in FIG. 69 to the position shown in FIGS. 70 and 71,
legs 810, 812 will be deformed or crimped permanently into the
position shown by respective pockets 830. At the locations
proximate longer legs 810, this will lock anchor members 802, 804
to the tendon tissue 834 and, more specifically, to the tendon
fibers comprising tissue 834. At the area of proximate short legs
812, anchor members 802, 804 will be crimped more directly onto
elongate tensile member 808. This action is brought about by the
tapered angle of grippers 826, 828 as illustrated in FIG. 68 and by
comparing FIGS. 70 and 71 which show the grippers in the same
actuated position.
[0228] In this embodiment, tool 820 may be actuated to a first
position sufficient to grip tendon fibers 834, but still allow
sliding motion along elongate tensile member 808. Using tool 820,
or another method, tendon 806 may then be pulled to a repair
position by sliding anchor members 802, 804 along elongate tensile
member 808. At the appropriate repair position, the crimp may be
finished by further actuating tool 820 to the position shown in
FIGS. 70 and 71. In a tendon-to-tendon repair, as with the previous
embodiments, one pair of anchor members 802, 804 may be rigidly
affixed to tendon 806 in the manner illustrated in FIGS. 70 and 71,
on one side of a tear, and the sliding adjustment may be
accomplished in the opposite side of the tear followed by a final
crimping action on a second set of anchor members 802, 804 as
described above.
[0229] FIGS. 72-74 illustrate another apparatus similar to FIGS.
67-71, but employing a single anchor member 840 having respective
long and short legs 842, 844. The operation of this embodiment is
similar to the previous embodiment, except that only one of the
opposed jaws would require an anvil surface, such as one comprised
of recesses or pockets, in order to bend legs 842 into a position
suitable for tightly gripping tendon tissue 834 against elongate
tensile member 808 and also tightly deforming legs 844
substantially directly against elongate tensile member 808 as shown
in FIG. 74. Again, this embodiment comprises an anchor structure
having an anchor member 844 with at least one portion movable with
respect to another for gripping and compressing tendon tissue
therebetween. Furthermore, before the final crimping action takes
place, anchor member 840 can initially grip tissue 834 and move
along elongate tensile member 808 to a suitable repair position
where upon the surgeon may finally crimp anchor member 840 securely
against elongate tensile member 808 as shown in FIG. 74. As further
shown in FIG. 74, each access incision 814, 816 is then closed
using stitches 846, 848 or another suitable method.
[0230] Referring now to FIGS. 75 and 76, another embodiment of the
invention is described in connection with tendon-to-tendon or
ligament-to-ligament repair, however, it will be appreciated that
this embodiment will also be useful for other procedures. In this
embodiment, an anchor assembly 850 is comprised of a helical anchor
852 and a core portion or tendon fiber retaining member 854.
Helical anchor 852 has proximal and distal ends 856, 858 and
retaining member likewise has proximal and distal ends 860, 862.
The distal end 858 of helical anchor 852 extends distally beyond
the distal end 862 of retaining member 854 and is sharpened to a
point 864 to aid in insertion. In addition, retaining member 854 is
tapered at its distal end 862 creating a space 866 between coils
852a of the helical anchor 852 and the outside surface 868 of the
retaining member 854 for receiving and retaining tendon or ligament
fibers 870 therein at least at a location near distal ends 858,
862. The proximal end 856 of helical anchor 852 is fixed to a
proximal end portion 872 of retaining member 854. This may be
accomplished in various ways, however, in the preferred embodiment,
the proximal end 856 is retained in a slot 874 and is welded such
as through a laser or resistence welding operation. The proximal
end 860 of retaining member 854 includes a slot 876 for receiving
an insertion tool and, if necessary, a removal tool to be described
below. Slots 874, 876 may communicate with each other as shown.
Retaining member 854 includes a central longitudinal bore 878 for
receiving an elongate, preferably flexible, tensile member 880.
Finally, a crimp member 882 is provided and may be a separate
member with a central bore 884 for receipt on elongate flexible
tensile member 880 or, as previously described, it may be integral
with retaining member 854 or a different type of locking member may
be used instead.
[0231] FIGS. 77, 78 and 78A illustrate an anchor assembly insertion
tool 890 for inserting the anchor assembly 850 of FIG. 75 within a
tendon or ligament 892. Insertion tool 890 comprises an elongate
body portion 894 having a rotatable knob 896 at a proximal end 898
and having a needle-shaped drive portion 900 at a distal end 902. A
flexible cable or shaft 904 is coupled between knob 896 and
needle-shaped drive portion 900 and, in the preferred embodiment,
this cable 904 is both rotated and translated as knob 896 is
rotated in the direction of arrows 906. A threaded coupling 908
within the elongate body portion 894 allows the simultaneous
rotation and translation around and along axis 912 as knob 896 is
rotated. Needle-shaped drive portion 900 is rigidly affixed to
flexible cable 904 as shown in FIG. 78A through the use of a
coupling member 914 and, preferably, an anchor assembly 850 as
shown in FIG. 75 is retained within a curved, tubular housing 916
which does not rotate but retains rotatable cable 904 therein.
Needle-shaped drive portion 900 includes a needle 918 which extends
through anchor assembly 850 and further includes a projecting
portion 920 which is complimentary to the tool engaging slot
portion 876 of anchor assembly 850 and fits therein to allows
rotation and translation of assembly 850 as the needle 918 is both
rotated and translated into the tendon or ligament in the direction
of arrow shown in FIG. 78A. As more specifically shown in FIG. 79,
anchor assembly 850 is rotated and translated, or moved axially,
into a tendon or ligament 892 and fibers 870 are captured during
this insertion process between the coils 852a of anchor 852 and the
outside surface 868 of retaining member 854. During the insertion
process, the coils 852a expand slightly outward away from the outer
surface 868 of retaining member 854 due to their inherent spring
action and, also due to their spring action, spring back to apply a
force against the tendon or ligament fibers 870 and against the
outer surface 868 of the retaining member 854. This forcefully
traps fibers 870 and strengthens the connection between anchor
assembly 850 and the tendon or ligament fibers 870.
[0232] FIGS. 80 and 80A illustrate a pistol grip device 940 for
driving the shaft 904 of the tool 890 as generally shown in FIGS.
77 and 78. Device 940 replaces knob 896 to allow one-handed
operation by a surgeon. In this embodiment, a firing lever 942 may
be actuated toward a handle 944 with a single hand of the surgeon
to rotate the firing lever 942 about a pivot 946 and thereby drive
a rack gear 948 upwardly, via a connecting pin 948a, to rotate a
pinion gear 950 coupled for rotation with flexible shaft 904. In
this embodiment, shaft 904 includes an externally threaded portion
904a and an internally threaded nut 952 is rigidly affixed, so as
not to rotate, within device 940. Threaded portion 904a engages the
internal threads of nut 952 and as shaft 904 rotates through the
interaction of rack and pinion 948, 950, shaft 904 also translates
to the left, as viewed in FIG. 80, to move drive portion 900 and
anchor assembly 850 (FIG. 78A) into tendon or ligament 892.
Alternatively, if a translation mechanism were not provided, the
surgeon could translate the anchor assembly 850 manually into the
tendon or ligament 892 by simultaneously pushing the pistol grip
handle assembly 940 while actuating the firing lever 942. Other
forms of pistol grip or other one-handed actuators may be used and
configured in any number of ways by those of ordinary skill to
simultaneously rotate and, optionally, translate shaft 904.
[0233] FIGS. 81-87 illustrate one preferred method out of many
possible methods for utilizing anchor assembly 850 of FIG. 75. In
this regard, two anchor assemblies 850 are respectively driven into
tendon or ligament segments 892a, 892b as shown in FIG. 81 and in a
manner such as described above. An assembly 960 comprised of a
distal needle 962 coupled with a flexible elongate tensile member
880, such as a multi-filament suture, and a preset crimp member 964
crimped onto a proximal end 966 of elongate tensile member 880 is
threaded through a first one of the anchor assemblies 850 using a
tool 968 until needle 962 is positioned between tendon or ligament
segments 892a, 892b as shown in FIG. 81. From the opposite side, a
second tool 970 is used to thread a capturing member, which may be
a conventional syringe or vena-puncture needle 972, through the
second anchor assembly 850 and into the space 974 between tendon or
ligament segments 892a, 892b. The first needle 962 is then captured
by inserting its end into the hollow interior of the syringe needle
972 and the connected assembly is then withdrawn through the second
anchor assembly 850 as shown in FIGS. 82 and 83. Alternatively,
elongate tensile member 880 may be pushed through the second anchor
assembly 850 without first being captured in space 974.
[0234] Tendon or ligament segments 892a, 892b are then drawn
together using the well-secured anchor assemblies 850 as shown in
FIGS. 84 and 85. Anchor assembly 850 in ligament segment 892a is
pulled by preset crimp member 964 as anchor assembly 850 in
ligament segment 892b is pushed using crimp member 882 and a crimp
tool 980. Crimp tool 980 is used to collapse crimp member 882 onto
the flexible elongate tensile member 880 to retain the second
anchor assembly 850 in position within segment 892b. The first
anchor assembly 850 is retained in position by the preset crimp
member 964 as previously described. Thus, the tendon or ligament
segments 892a, 892b are held at the desired positions relative to
each other as determined by the surgeon. The excess length of the
elongate tensile member 880 is then cut with a cutting tool 982 at
a location adjacent the proximal end of the crimp member 882 as
generally shown in FIG. 86 and, as shown in FIG. 87, the access
incisions are closed, such as by suturing, and a running suture, or
other means, may be used to secure the ends of the tendon or
ligament segments 892a, 892b.
[0235] FIG. 88 shows the jaws 990, 992 of crimp tool 980 in more
detail. One jaw 990 includes a projection 990a for collapsing crimp
member 882 against a recess 992a formed in the jaw 992. The recess
992a in the opposite jaw includes a ridge 994 which helps retain
crimp member 882 in place within the jaws 990, 992, such as during
shipping and during use by the surgeon. As also shown in FIGS. 84
and 85, one or more flexible bars 996a, 996b are provided between
opposing handles 998a, 998b of crimp tool 980. These bars 996a,
996b retain the jaws 990, 992 at predetermined positions which hold
the crimp member 882 in place during packaging, shipping and
storage, but prevent jaws 990, 992 from coming together during
application of relatively light loads to prematurely collapse the
crimp member 882. During use by the surgeon, however, the flexible
bar or bars 996a, 996b do not prevent manual actuation of the
handles 998a, 998b to bring the jaws 990, 992 together and collapse
the crimp member 882 as shown in FIG. 85.
[0236] FIGS. 89 and 90 illustrate a removal tool 1000 which, in
certain cases, may be necessary to remove an anchor assembly 850.
Specifically, removal tool 1000 is in the general form of a
rotatable hand tool generally similar to a screwdriver. However, as
shown in FIG. 90, tool 1000 includes a head portion 1002 having a
needle 1004 extending from a drive portion 1006. Needle 1004
extends through the central bore 878 of anchor assembly 850 and
drive portion 1006 engages slot 876 of anchor assembly in a manner
similar to a screwdriver to allow rotation of anchor assembly 850.
In the configuration shown, counterclockwise rotation of tool 1000
and anchor assembly 850 will back the anchor assembly 850 out of
the tendon or ligament 892, for example, if the anchor assembly 850
is malpositioned.
[0237] While the present invention has been illustrated by a
description of the preferred embodiments and while these
embodiments have been described in some detail, it is not the
intention of the Applicants to restrict or in any way limit the
scope of the appended claims to such detail. The present disclosure
has been illustrative of many features which may be modified, and
configured in many different sizes depending on the intended use.
The various embodiments and features of the invention may be used
singularly or in various combinations not to be limited by the
detail provided herein. Additional advantages and modifications
will readily appear to those skilled in the art. This has been a
description of the present invention, along with the preferred
methods of practicing the present invention as currently known.
Various aspects of this invention may be used alone or in different
combinations. The scope of the invention itself should only be
defined by the appended claims, wherein we claim:
* * * * *