U.S. patent application number 14/451351 was filed with the patent office on 2015-07-23 for method and apparatus for repairing a tendon or ligament.
The applicant listed for this patent is Leonard Gordon, Shawn T. Huxel, Allen B. Miller, Mari Susan Truman. Invention is credited to Leonard Gordon, Shawn T. Huxel, Allen B. Miller, Mari Susan Truman.
Application Number | 20150201924 14/451351 |
Document ID | / |
Family ID | 43920366 |
Filed Date | 2015-07-23 |
United States Patent
Application |
20150201924 |
Kind Code |
A1 |
Gordon; Leonard ; et
al. |
July 23, 2015 |
METHOD AND APPARATUS FOR REPAIRING A TENDON OR LIGAMENT
Abstract
A method and apparatus for reattaching the opposed ends of a
member, such as a tendon, ligament or bone, during preparing and
healing of the member using a surgical repair device that can be
securely attached to the member and then safely guided through
tortuous anatomy for reattachment and repair. The repair device
further includes structural means so as to secure opposed ends of
the member against separation during healing. Devices for aiding in
the positioning of the surgical repair device are provided.
Inventors: |
Gordon; Leonard; (Mill
Valley, CA) ; Huxel; Shawn T.; (Lawrenceville,
NJ) ; Truman; Mari Susan; (Warsaw, IN) ;
Miller; Allen B.; (Jamison, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Gordon; Leonard
Huxel; Shawn T.
Truman; Mari Susan
Miller; Allen B. |
Mill Valley
Lawrenceville
Warsaw
Jamison |
CA
NJ
IN
PA |
US
US
US
US |
|
|
Family ID: |
43920366 |
Appl. No.: |
14/451351 |
Filed: |
August 4, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12716724 |
Mar 3, 2010 |
8795333 |
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14451351 |
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PCT/US2008/066754 |
Jun 12, 2008 |
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12716724 |
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61304003 |
Feb 12, 2010 |
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Current U.S.
Class: |
606/144 ;
606/191; 606/232 |
Current CPC
Class: |
A61F 2/0811 20130101;
A61B 2017/044 20130101; A61B 2017/0472 20130101; A61M 25/0023
20130101; A61B 17/0482 20130101; A61B 2017/0414 20130101; A61B
2017/1103 20130101; A61M 29/00 20130101; A61B 17/0487 20130101;
A61B 17/0401 20130101; A61B 17/1146 20130101; A61B 2017/06057
20130101; A61B 17/3468 20130101; A61B 17/0469 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 17/34 20060101 A61B017/34; A61F 2/08 20060101
A61F002/08; A61M 29/00 20060101 A61M029/00; A61B 17/11 20060101
A61B017/11 |
Claims
1. A dilation system comprising: a dilation catheter comprising a
tube having a lumen, the tube increasing in diameter from a first
longitudinal end to a second longitudinal end.
2. The dilation system of claim 1 wherein the dilation catheter
comprises a plurality of consecutive longitudinal segments, each
consecutive longitudinal segment having an outer diameter over a
majority of its length greater than an outer diameter of a
preceding longitudinal segment.
3. The dilation system of claim 1 further comprising: a guide
member comprising an elongate member for passing through an
anatomical passage; wherein the lumen of the dilation catheter is
of sufficient size and shape to accept the guide member
therethrough so that the dilation catheter may be slid over the
guide member.
4. The dilation system of claim 3 wherein the guide member is
longer than the dilation catheter.
5. The dilation system of claim 1 wherein the dilation catheter is
unitary.
6. The dilation system of claim 1 wherein the longitudinal segments
of the guide catheter are separable.
7. The guide system of claim 6 wherein each longitudinal segment of
the dilation catheter has a first longitudinal end and a second
longitudinal end, each end adapted to form an interference fit with
a longitudinal end of a next consecutive longitudinal segment of
the dilation catheter.
8. The dilation system of claim 7 wherein the first end of each
longitudinal segment other than a first of said longitudinal
segments has a necked down portion adapted to fit in an
interference fit within the lumen of a next smaller diameter
longitudinal segment of the dilation catheter.
9. The dilation system of claim 1 wherein the guide member and the
dilation catheter are flexible.
10. The dilation system of claim 2 wherein each longitudinal
segment is longer than an anatomical passage through which the
catheter is intended to pass.
11. The dilation system of claim 2 wherein each longitudinal
segment of the dilation catheter has a first end adjacent the
preceding segment and a trailing end adjacent the succeeding
segment and wherein each longitudinal segment other than a first
segment with a smallest outer diameter includes a first portion
adjacent the first longitudinal end that increases in outer
diameter gradually from a first diameter substantially equal to the
outer diameter at the trailing end of a preceding longitudinal
segment to a second diameter larger than the first diameter, and a
second portion having a constant outer diameter over its length
substantially equal to the second diameter.
12. The dilation catheter of claim 1 wherein the catheter is
tapered over its entire length.
13. An apparatus for reattaching a longitudinal anatomical feature
to another anatomical feature comprising: a first repair device
having at least a first filament having a first longitudinal end
and a second longitudinal end, a first needle attached to the first
end and a second needle attached to the second end; a catheter
comprising a tube having a lumen; a funnel member having a smaller
longitudinal end for placement adjacent an entry to an anatomical
passageway and a larger longitudinal end.
14. The apparatus of claim 13 wherein the funnel member does not
form a complete frustoconical surface and includes a lateral
opening in the surface thereof for lateral insertion of the
longitudinal anatomical feature.
15. The apparatus of claim 13 wherein the catheter has a plurality
of consecutive longitudinal segments, each consecutive longitudinal
segment having an outer diameter over a majority of its length
greater than a diameter of a preceding longitudinal segment.
16. The apparatus of claim 15 further comprising: an elongate guide
member for passing through an anatomical passage; wherein the lumen
is of sufficient size and shape to accept the guide member
therethrough so that the dilation catheter may be slid over the
guide member.
17. The apparatus of claim 16 wherein the guide member is longer
than the dilation catheter.
18. The apparatus of claim 15 wherein each longitudinal segment is
longer than an anatomical passage that the catheter is intended to
traverse.
19. The apparatus of claim 13 further comprising a sheath
surrounding at least the second needle of the at least one
filament.
20. The apparatus of claim 19 wherein the sheath further surrounds
at least a portion of each of the first and second filaments.
21. The apparatus of claim 20 wherein the sheath further comprises
a longitudinal strip for tearing the sheath longitudinally.
22. The apparatus of claim 19 wherein the sheath is longer than the
longitudinal segments of the dilation catheter individually.
23. The apparatus of claim 13 wherein the catheter comprises a
first catheter comprising a hollow tube of relatively constant
diameter adapted to accept the first repair device therethrough and
having a first end and a second end; and a second catheter
comprising a hollow tube adapted to accept the first repair device
therein and having a first end adapted to be coupled to the second
end of the first catheter and a second, tapered end.
24. The apparatus of claim 23 wherein the second tapered end of the
second catheter is collapsible.
25. The apparatus of claim 24 further comprising a second repair
device comprising a bone anchor having a distal end for attaching
the bone anchor fixedly to bone and a proximal end having at least
one filament extending therefrom.
26. The apparatus of claim 13 wherein the first and second needles
are straight needles.
27. A method of retrieving through an anatomical passage a first
stump of a longitudinal anatomical feature for reattachment to
another anatomical feature, the method comprising: providing a
first repair device having a first longitudinal end and a second
longitudinal end, the first repair device including at least one
filament having a first longitudinal end defining the first
longitudinal end of the first repair device and a second
longitudinal end defining the second longitudinal end of the first
repair device, a first needle attached to the first end of the at
least one filament; retrieving the first stump through a first
opening in a patient; stitching the at least one filament to the
first stump using the first needle; passing a catheter having a
first longitudinal end and a second longitudinal end through the
anatomical passage between the first opening and a second opening;
inserting at least the second longitudinal end of the at least one
filament of the first repair device into the catheter from the
first opening; and pulling the catheter, the first repair device,
and the first stump attached to the first repair device from the
second opening.
28. The method of claim 27 further comprising a second needle
attached to the second end of the at least one filament wherein the
inserting comprises inserting both the first and second
longitudinal ends of the at least one filament into the
catheter.
29. The method of claim 27 wherein the inserting comprises passing
the at least one filament through the catheter to a point where the
second longitudinal end of the first filament extends from the
second longitudinal end of the catheter and an end of the stump is
adjacent the first longitudinal end of the catheter.
30. The method of claim 29 wherein the passing comprises inserting
at least a portion of the at least one needle into a rod and
pushing the filament, needle and tube through the catheter from the
first opening to the second opening.
31. The method of claim 30 wherein the rod is a tube having a lumen
and wherein the inserting comprises inserting the at least one
needle into the lumen in the tube.
32. The method of claim 29 wherein the passing comprises: inserting
a tube through the catheter and extending from both ends of the
catheter; subsequently lodging at least a portion of the at least
one needle into the tube from the first opening; and pulling the
tube through the catheter from the second opening, whereby the
needle and filament are pulled through the catheter from the first
opening to the second opening.
33. The method of claim 29 wherein the pulling comprises pulling
the repair device, first stump, and catheter simultaneously as a
unit.
34. The method of claim 33 wherein the passing comprises: passing
an elongate guide member between the first opening and the second
opening; passing the catheter over the guide member between the
first opening and the second opening; and subsequently removing the
guide member.
35. The method of claim 34 wherein the catheter comprises a
dilation catheter comprising a tube having a lumen, the tube having
a plurality of consecutive longitudinal segments, each consecutive
longitudinal segment having an outer diameter over a majority of
its length greater than an outer diameter of a preceding
longitudinal segment, and wherein the passing comprises: dilating
the anatomical passage by passing the catheter through the
anatomical passage starting with a smallest one of the longitudinal
segments until a certain one of the longitudinal segments of the
catheter dilates the anatomical passage a desired amount.
36. The method of claim 35 wherein each longitudinal segment is
longer than the anatomical passage the catheter is intended to
traverse and wherein the passing comprises positioning the certain
one of the longitudinal segments so that it entirely occupies the
anatomical passage between the first opening and the second
opening.
37. The method of claim 36 wherein the passing further comprises
removing the longitudinal segments other than the certain one of
the longitudinal segments from the catheter after the
positioning.
38. The method of claim 37 wherein the removing comprises cutting
the catheter.
39. The method of claim 35 wherein the pulling comprises: pulling
the repair device, catheter, and first stump simultaneously as a
unit through the anatomical passage.
40. The method of claim 39 wherein the pulling further comprises:
pulling the unit through the anatomical passage until the stump is
adjacent an entry to the anatomical passage; positioning a funnel
member having a smaller longitudinal end and a larger longitudinal
end with the smaller longitudinal end adjacent the entry to the
anatomical passage; placing the first stump in the funnel member;
and pulling the unit to cause the stump to slide through the funnel
member into the anatomical passage.
41. The method of claim 37 further comprising: attaching a bone
anchor to a bone; removing the first repair device from the
catheter; and attaching the first repair device to the bone
anchor.
42. The method of claim 41 wherein the attaching the first repair
device to the bone anchor comprises attaching the at least one
filament to the bone anchor.
43. The method of claim 41 wherein the bone anchor comprises an
eyelet and the attaching the first repair device to the bone anchor
comprises threading the at least one filament of the first repair
device through the eyelet of the bone anchor.
44. The method of claim 27 further comprising: removing the first
repair device from the catheter; and attaching the first repair
device to a second stump of the longitudinal anatomical
feature.
45. The method of claim 44 wherein the first repair device further
comprising a second needle attached to the second end of each of
the at least one filament, and wherein the attaching the first
repair device to the second stump of the longitudinal anatomical
feature comprises stitching the at least one filament to the second
stump.
46. The method of claim 27 further comprising: providing a second
repair device having a first longitudinal end and a second
longitudinal end, the second repair device including at least one
filament having a first longitudinal end and a second longitudinal
end, a first needle attached to the first end of the at least one
filament of the second repair device; attaching the second repair
device to a second stump of the longitudinal anatomical feature
using the first needle of the at least one filament of the second
repair device; pulling the first stump and the second stump toward
each other so that the ends of the first and second stumps abut;
stitching the first repair device to the second stump; and
stitching the second repair device to the first stump.
47. The method of claim 27 further comprising: providing a bone
anchor comprising at least one filament having a first longitudinal
end attached to the bone anchor and a second longitudinal end
bearing a needle; attaching the bone anchor to a bone; passing the
at least one filament of the bone anchor through a second stump of
the longitudinal anatomical feature; pulling the first stump toward
the second stump so that the ends of the first and second stumps
abut; stitching the first repair device to the second stump; and
stitching the at least one filament of the bone anchor to the first
stump using the needle of the bone anchor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 12/716,724, filed 3 Mar. 2010, which is a
Continuation-in-Part of PCT/US08/066754, filed 12 Jun. 2008 and
claims the benefit of U.S. Provisional Application No. 61/304,003,
filed 12 Feb. 2010, all of which are incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] The invention pertains to methods and apparatus for
repairing tendons, ligaments, and the like. More particularly, the
invention pertains to surgical implants and techniques for
repairing severed or injured tendons and ligaments. It is
particularly well-suited for repairing tendons and ligaments of the
extremities with minimal disruption of the surrounding tissues.
BACKGROUND OF THE INVENTION
[0003] The current standard of care for repairing severed tendons
in the hand is to re-attach the two separated ends of the tendon
with nothing but sutures. The two ends of the tendon are held
together by the suture while the tendon heals. Surgical repair of
tendons and ligaments, particularly flexor tendons, has been
accurately described as a technique-intensive surgical
undertaking.
[0004] The repair must be of sufficient strength to prevent gapping
at the opposed end faces of the repaired member to allow the member
to reattach and heal as well as to permit post-repair application
of rehabilitating manipulation of the repaired member. Considerable
effort has been directed toward the development of various suturing
techniques for this purpose. Two strand, four strand, and six
strand suturing techniques, primarily using locking stitches, have
been widely used. There are a wide variety of suturing patterns
which have been developed in an effort to attempt to increase the
tensile strength across the surgical repair during the healing
process. A common suturing technique in recent times is known as
the Kessler repair, which involves the use of sutures that span, in
a particular configuration or pattern, across the opposed severed
ends of the tendon (or ligament). Evans and Thompson, "The
Application of Force to the Healing Tendon" The Journal of Hand
Therapy, October-December, 1993, pages 266-282, surveys the various
suturing techniques that have been employed in surgical tendon
repair. Further, two articles by Strickland in the Journal of
American Academy of Orthopaedic Surgeons entitled "Flexor Tendon
Injuries: I. Foundations of Treatment" and "Flexor Tendon Injuries:
II. Operative Technique", Volume 3, No. 1, January/February, 1995,
pages 44-62, describe and illustrate various suturing
techniques.
[0005] Generally, the tensile strength of a tendon repair increases
with increased complexity of the suturing scheme. As set forth in
the Evans and Thompson article, the loads at which failure occur
across a sutured joint can vary between about 1,000 grams force to
as much as about 8,000 grams force (or about 10 to 80 Newtons).
There are at least two modes of potential failure, including
breakage of the sutures or the sutures tearing out of the tendon.
The Kessler and modified Kessler repair techniques tend to exhibit
failure toward the low end of the range, for example, between about
1,500 to 4,000 grams force (or about 15 to 40 Newtons), which is
much weaker than the original tendon and requires the patient to
exercise extreme care during the healing process so as not to
disrupt the tendon repair.
[0006] For instance, normal flexing of the fingers of the hand
without any load generates forces of about 40 Newtons (N) on the
tendon. Flexing with force to grasp something with the hand
typically will place a force of about 60 N-100 N on the tendon.
Finally, strong grasping of an object, such as might be involved in
an athletic activity or in lifting of a heavy object can place
forces on the tendons of the hand on the order of 140 N or
more.
[0007] The various suturing techniques also are rather complex and,
therefore, difficult to reproduce and perfect as a technique, let
alone perform it on the small tendons in the hand. Further, because
they employ locking stitches, the two tendon ends must be brought
to and maintained in the correct position relative to each other
(i.e., with the ends in contact) throughout the entire procedure
because the locking stitches do not permit future adjustment of the
repair (as did some of the earlier techniques that do not use
locking stitches).
[0008] Another significant difficulty with repairing lacerated and
avulsed tendons in the hand, and, particularly, in the fingers is
the need to re-route the severed tendon (usually the proximal
tendon stump) through the pulley system of the finger joint.
Specifically, when a tendon is severed or avulsed, the proximal
tendon stump tends to recoil away from the laceration site toward
the wrist. Accordingly, it often is necessary to make a
longitudinal incision proximal to the laceration site in order to
retrieve the proximal portion of the severed tendon and guide it
through the pulley system of the finger back to the laceration site
for reattachment to the distal tendon stump.
[0009] As reported in Evans and Thompson, at least one researcher
has employed a Mersilene mesh sleeve having a diameter slightly
larger than the tendon that is subsequently sutured to the two
opposed tendon ends. Experimental failure loading as high as 10,000
grams force (100 N) was reported using the sleeve. However,
Mersilene, which is a non-degradable polyester, a common material
used for manufacturing sutures used in orthopedics, has the
disadvantage that human tissue will experience a local tissue
response leading to adhesion of the polyester to tissue surrounding
the repair site. This is undesirable in tendons and ligaments since
the tendon must be able to glide freely relative to the surrounding
tissue, such as the pulleys in the fingers. While a sleeve may be
well suited for use with tendons and ligaments which are
substantially cylindrical, it is less easily employed with tendons
having a flat or ovaloid cross section. Moreover, any added bulk,
in this case to the outside of the tendon, could be problematic as
this repair would have to traverse the pulley system of the
fingers.
[0010] U.S. Pat. No. 6,102,947 discloses another method and
apparatus for repairing tendons that involves an implant that can
be sutured to the tendon and which provides a splint running
between the two tendon ends. The implant essentially comprises a
wire bearing a first pair of wedges on one side of the midpoint of
the wire with their pointed ends facing away from the midpoint and
a second pair of wedges on the other side of the midpoint of the
wire with their pointed ends also facing away from the midpoint
(i.e., facing oppositely to the first pair of wedges). The first
pair of wedges is pushed (or pulled) into one of the severed ends
of the tendon and the other pair is pushed (or pulled) into the
other severed end of the tendon. The wedges are sutured to the
tendon and are retained within the tendon. This system provides
high tensile strength to the repair.
[0011] Further, Ortheon Medical of Winter Park, Fla., USA developed
and commercialized an implant for flexor tendon repair called the
Teno Fix. The Teno Fix implant is substantially described in Su, B.
et al, "A Device for Zone-II Flexor Tendon Repair: Surgical
Technique", The Journal of Bone and Joint Surgery, March 2006,
Volume 88-A-Supplement 1, Part 1. The assembled implant comprises
two intratendonous, stainless-steel anchors (in the form of a coil
wrapped around a core) joined by a single multi-filament stainless
steel cable. The implant is delivered to the surgeon unassembled,
comprising a stainless steel cable with a stop-bead affixed to one
end of the cable, two separate anchors with through bores for
passing the cable therethrough, and another stop-bead with a
through bore for passing the cable therethrough.
[0012] In practice, one of the anchors is advanced into a
longitudinal intratendonous split (tenotomy) made in the proximal
tendon stump so that the anchor sits within the longitudinal
tenotomy and engages the tendon substance by capturing tendonous
fibers between the core and the anchor. The other anchor is placed
in the distal tendon stump in the same manner. Next, a straight
needle with the stainless-steel cable attached thereto is threaded
into the through-bore of the distal anchor from the small end of
the anchor and is pulled through the center of the cut surface of
the distal tendon stump until the stop-bead at the end of the cable
opposite the needle contacts the distal anchor. The stainless-steel
cable with the needle attached is then guided into the cut end of
the proximal stump and through the through-bore of the anchor in
the proximal stump from the large end of the anchor to the small
end. The proximal stump of the tendon is then brought into contact
with the distal stump by tensioning the cable, and the second
stop-bead is placed over the stainless-steel cable at the proximal
end of the proximal anchor. The second stop-bead is then crimped to
lock it to the cable and the excess cable is cut so that the cable
end is flush with the second stop-bead.
[0013] A disadvantage of the Teno Fix is the size of the tendon
anchor, which is large and, thus, may add resistance to the tendon
as it passes through the pulley system. Another disadvantage of the
Teno Fix is the invasive nature of implanting the device wherein
the entire track of skin over the tendon path must be incised in
order to effect the implantation of the device. A third
disadvantage is that the attachment of the anchor to the tendon is
rather weak, reporting only about 46 Newtons of pull strength.
These disadvantages are overcome by the subject and method
described in this invention.
[0014] A disadvantage of most, if not all, of the prior art
techniques discussed above is a high infection rate.
SUMMARY OF THE INVENTION
[0015] The invention comprises methods and apparatus for
reattaching the opposed ends of an anatomical member, such as a
tendon, ligament, or bone, during preparing and healing of the
member using a surgical repair device that can be securely attached
to the member and then safely guided through tortuous anatomy for
reattachment and repair. The repair device further includes
structural means to secure opposed ends of the member against
separation during healing. Devices for aiding in the positioning of
the surgical repair device also are provided.
DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 shows the various components that may be used for
repairing a severed member, such as a tendon or ligament, in
accordance with a first embodiment of the apparatus of the
invention.
[0017] FIGS. 2A-2L illustrate various stages of a surgical
procedure in accordance with a first embodiment of the method in
accordance with the invention.
[0018] FIG. 3 is a photograph of a completed tendon repair in
accordance with the first embodiment.
[0019] FIGS. 4A-4D illustrate various stages of a surgical
procedure in accordance with another embodiment of the method in
accordance with the invention.
[0020] FIG. 5 shows apparatus for reattaching a member in
accordance with another embodiment of the invention.
[0021] FIG. 6A illustrates an alternative connector for
interconnecting two tendon repair devices in accordance with the
principles of the present invention.
[0022] FIG. 6B illustrates a procedure for locking the cables of
two tendon repair devices in the connector of FIG. 7A.
[0023] FIG. 7 illustrates the pulley system of the finger.
[0024] FIG. 8A illustrates an alternate embodiment of a tendon
repair device in accordance with the principles of the present
invention.
[0025] FIG. 8B illustrates the tendon repair device of FIG. 9A as
it is preferably delivered to the surgical site.
[0026] FIGS. 9A through 9D illustrate another embodiment of a
tendon repair device and technique in accordance with the
principles of the preset invention.
[0027] FIG. 10A illustrates another alternate embodiment of a
tendon repair device in accordance with the principles of the
present invention.
[0028] FIG. 10B illustrates two of the devices of FIG. 10A used to
repair a tendon.
[0029] FIG. 11A illustrates an alternative apparatus in accordance
with the invention.
[0030] FIGS. 11B-11F illustrate another alternate technique using
the apparatus of FIG. 11A.
[0031] FIG. 12A illustrates an alternative apparatus in accordance
with the invention.
[0032] FIGS. 12B-12C illustrate another alternate technique using
the apparatus of FIG. 12A.
[0033] FIG. 13A is a perspective view of one embodiment of a
unitary dilation catheter in accordance with another
embodiment.
[0034] FIG. 13B is a perspective view of one embodiment of a
multi-piece dilation catheter in accordance with another
embodiment.
[0035] FIG. 13C is a perspective view of one embodiment of a guide
member for the dilation catheters of FIGS. 13A and 3B.
[0036] FIGS. 14A-14G illustrate another alternate technique using
the apparatus of FIG. 13A or FIG. 13B.
[0037] FIG. 15 illustrates a tendon bearing a modified cruciate
repair stitch.
[0038] FIG. 16 is a perspective view of a tendon holder in
accordance with another embodiment of the invention.
DETAILED DESCRIPTION
[0039] In accordance with the present invention, a surgical implant
and associated technique is disclosed for repairing tendons,
ligaments, and the like following laceration, avulsion from the
bone, or the like. The invention is particularly adapted for
repairing a lacerated or avulsed flexor tendon, e.g., flexor
digitorum profundus from the distal phalanx and/or the flexor
digitorum superficialis from the middle phalanx.
First Set of Exemplary Embodiments
[0040] FIG. 1 illustrates the components in accordance with a first
embodiment of the invention. As will be described in detail below,
not all of the components necessarily will be used in each surgical
procedure. The components include a pulley catheter 101 which will
be used, if needed, to guide the tendon repair device of the
present invention along with a severed tendon stump, ligament
stump, or similar anatomical feature through one or more anatomical
restrictions to the repair site, e.g., through the pulley system of
the finger. The components further include a flanged catheter 103,
which will be used to guide a severed tendon stump through
anatomical restrictions to the repair site, if necessary. A
catheter connector 105 may be used to connect the pulley catheter
101 and the flanged catheter 103 together end to end, as will be
described in detail below. The catheter connector 105 may be a
metal dowel. A tendon holder tool 107 may be used, as necessary, to
hold the tendon during the surgical repair procedure.
[0041] One or more of the tendon repair devices 109 are the actual
devices that will effect the repair by reattaching two tendon
stumps. Each tendon anchor 109 comprises a multi-filament
stainless-steel cable 110. From one end 141 of the cable to an
intermediate point 143 of the cable, the individual filaments of
the cable are wound in the normal fashion to form a single cable
portion 144. A straight needle 111 is attached to the first end 141
of the cable. From the intermediate point 143 in the direction
opposite from end 141, the individual filaments of the cable are
unwound so as to form a plurality of (in this particular
embodiment, seven) separate sutures 147a-147g. A needle, preferably
a curved needle 114a-114g, is attached to the end of each of the
seven separate cable portions 147a-147g. A fitting attached at the
intermediate point 143 keeps the cable portion 144 from unwinding.
The fitting, for instance, may be a sleeve 149. In one preferred
embodiment of the invention, the stainless-steel cable is formed of
343 individual strands wound in groups of seven. Thus, from the
sleeve 149 to the first end 141, the cable 144 comprises 343
individual strands making up seven intermediate strands, and each
of the intermediate strands comprised of seven smaller wound
strands of 49 filaments each, and each of those smaller strands
comprised of seven individual strands of seven filaments each. In
the other direction from the sleeve 149, each of the seven
individual strands 147a-147g comprises seven of those smaller
strands wound together (wherein each of those smaller strands
comprises seven individual strands wound together).
[0042] The afore-described embodiment of the tendon repair device
109 is advantageous because it is particularly easy to fabricate
from widely available materials. (e.g., 343 strand stainless steel
suture cable and a crimp). The materials can be chosen from the
implantable family of metals and alloys including the stainless
steels, cobalt chrome alloys, titanium and its alloys and
nickel-titanium alloy (NiTinol). However, the tendon repair device
109 can be formed of other materials, such as a polymer fiber, and
assembled in other manners, such as braiding, welding, or molding.
For instance, it may be formed of individual filaments, fibers or
yarns welded together.
[0043] In the following discussion, in order to more clearly
differentiate them, the single ended portion 144 of the tendon
repair device 109 will be referred to as cable portion 144, whereas
the strands 147a-147g will be referred to as sutures. However, it
is to be understood that the use of these terms is not intended to
indicate that they are formed of different materials, since, for
instance, in the exemplary embodiment described herein, all of the
strands are formed of stainless steel wire.
[0044] A connector 112 is used to affix two tendon repair devices
109 to each other as will be described in detail below. The
connector 112 in this illustrated embodiment comprises a block of
material, preferably a deformable metal such as stainless steel,
having two side-by-side through bores 151, 152 having inner
diameters slightly larger than cable portion 144. As will be
described in greater detail below, near the end of the tendon
re-attachment procedure, each cable portion 144 will be inserted in
opposing directions through each through bore 151 and 152 of the
connector 112 and the connector will be deformed (i.e., crimped) to
lock the cable portions 144 therein.
[0045] Finally, a bone anchor 400 or 450 can be used in procedures
where the tendon has avulsed from the bone or has been severed too
close to the bone to provide sufficient tendon length to retain a
tendon repair device 109. In a first embodiment, the bone anchor
400 has a threaded distal end 401 for screwing securely into bone.
The proximal end 403 includes an eyelet 402 through which sutures
can be passed. As will be described in more detail hereinbelow, the
sutures can be tied in the eyelet. Alternately, the proximal end
403 can be formed of a deformable material, such as a thin-walled
metal, so that the eyelet can be crushed by a crimping tool to
capture the sutures therein. In a second embodiment, the bone
anchor 450 may be manufactured with one or more sutures 451
extending from the proximal end 455, such as four sutures 451a,
451b, 451c, 451d. The ends of the sutures are provided with needles
452a, 452b, 452c, 452d.
[0046] The tendon repair devices, surgical tools, and methods will
be described herein below in connection with the repair of a
lacerated flexor digitorum profundus at the level of the middle
phalanx. However, it should be understood that this is exemplary
only. Various stages of the procedure are illustrated by FIGS.
2A-2L.
[0047] First, if the proximal end of the divided tendon can be
reached from the wound site, then it is gently retrieved through
the wound to be held by the tendon holder 107.
[0048] The tendon holder 107 comprises a handle 201, a cross bar
203 at the distal end of the handle 201, and first and second
needles 205 and 207, respectively, extending distally from the
cross bar 203. The needles 205 and 207 are slidable laterally
within slots 209 and 211, respectively, in the cross bar 203.
Particularly, the proximal ends of the needles comprise a stop
shoulder 213, and an internally threaded bore running from the stop
shoulder 213 to the proximal end of the needle. A screw 217 can be
threaded into the proximal end of each needle 205, 207 to trap the
cross bar 203 between the head of the screw 217 and the stop
shoulder 213 of the needle 205, 207 to affix each needle in any
given position along its slot 209, 211.
[0049] Depending on the length of tendon extending outside of the
wound opening, the surgeon may pierce the tendon with one or both
of the needles 205, 207 of the tendon holder 107 to hold the tendon
outside of the wound. See FIG. 2C, for example, which illustrates
the tendon holder 107 holding a tendon stump 153a. The surgeon
preferably pierces the tendon about 1 cm from the severed end.
[0050] However, if the tendon is not readily retrievable from the
wound and must be accessed through another incision and brought
back to the wound site, the tendon holder 107 still may be used,
but first the tendon must be retrieved to the wound site. In such a
case, the pulley catheter 101 and flanged catheter 103 will be used
to retrieve the tendon. Specifically, the pulley catheter 101 is a
hollow plastic tube formed of a biocompatible polymer of such
composition and/or wall thickness so that it is relatively rigid,
but bendable. It might, for instance, have the approximate
flexibility of a typical surgical vascular catheter. The relative
rigidity of the pulley catheter will permit it to be pushed through
narrow anatomical passages, such as the pulleys of the fingers.
However, its flexibility will permit some bending to accommodate an
overall curved path. Preferably, the pulley catheter is formed of a
material having a low friction coefficient to allow the pulley
catheter to readily pass through and around bodily tissues such as
the tendon pulley system. Suitable biocompatible polymers include
homopolymers, copolymers and blends of silicone, polyurethane,
polyethylene, polypropylene, polyamide, polyaryl, flouropolymer, or
any other biocompatible polymer system that meets the mechanical
characteristics above. Various cross sections of the pulley
catheter other than a simple tubular structure can also be used,
such as a solid structure, multi-lumen, or complex geometry that
would provide the mechanical characteristics above. The coefficient
of friction of the surfaces of the pulley catheter may be inherent
to the materials used to construct the device or may be enhanced
through a surface preparation such as a lubricious coating or
mechanical modification of the surface such as longitudinal
recesses.
[0051] The particular length, material, wall thickness, inner
diameter, outer diameter, and stiffness of the pulley catheter 101
may vary greatly depending on the particular tendon or ligament
with which is it to be used. The length, of course, would be
dictated by the longest length that it might be required to
traverse. The inner diameter must be large enough to easily
accommodate the cable portion 144 of the tendon repair device 109.
The outer diameter must be small enough to pass through the anatomy
that it may be called upon to pass through. The particular material
and cross sectional geometry (e.g., wall thickness) of the pulley
catheter will largely dictate the stiffness of the catheter and, as
noted above, should be selected to provide enough rigidity to allow
it to be pushed through a narrow path, but flexible enough to bend
to accommodate bends in the path. In the exemplary case of the
flexor digitorum profundus at the level of the middle phalanx, the
pulley catheter may be formed of silicone and be 120 millimeters in
length with a wall thickness of 0.5 mm, and an outer diameter of 2
mm. A silicone having a durometer of 50-80 (Shore A) may be used
for the pulley catheter.
[0052] The flanged catheter 103 also is a hollow tube formed of a
biocompatible material, preferably a polymer. However, the flanged
catheter preferably is softer than the pulley catheter. The flanged
catheter has a first end 157 having a diameter that is
approximately equal to the diameter of the pulley catheter 103 so
that it can be connected end-to-end with the pulley catheter, as
described in more detail further below. It also has a flanged end
159 that is tapered so as to essentially form a funnel for
accepting the end of a tendon stump, also as will be described in
more detail further below. As will become clear in the ensuing
discussion, while the flanged catheter will traverse essentially
the same path as the pulley catheter, the pulley catheter will
guide or pull the flanged catheter into the anatomical path along
with the tendon repair device attached to the tendon stump inside
the flanged portion 159 of the flanged catheter. Accordingly, the
flanged catheter need not be rigid. Actually, the flanged catheter
should be relatively flexible because it may need to be bent into a
tortuous shape to accommodate passage of the cable portion 144 of
the tendon repair device 109. Furthermore, the flange portion 159
of the flanged catheter 103 particularly should be readily
collapsible in order to collapse around the tendon stump and pass
through narrow anatomical passages, such as the pulleys of the
fingers, with the tendon stump and tendon repair device enclosed
therein as will be described in more detail below.
[0053] The flanged catheter 103 should have a length, wall
thickness, inner diameter, outer diameter, and material composition
suited to its purpose. Its purpose is to allow the single-ended
portion 144 of the tendon repair device 109 to pass through it and
to follow the pulley catheter through an anatomical path, as will
be described more fully below. Accordingly, the flanged catheter
has a narrow end 157 and a wide end 158. The wide end terminates in
a cone or flange 159 in order to make it easier to insert the
straight needle 111 at the end of cable portion 144 of the tendon
repair device 109 into it as well as contain the tendon stump. The
narrow end 157 of the flanged catheter 109 is narrow in order to be
mated to the end of the pulley catheter.
[0054] The flanged catheter 103 also is preferably formed of a
material having a low friction coefficient to allow the flanged
catheter to readily pass through and around bodily tissues such as
the tendon pulley system. Such biocompatible polymers can be chosen
from homopolymers, copolymers, and blends of silicone,
polyurethane, polyethylene, polypropylene, polyamide, polyaryl,
flouropolymer, or any other biocompatible polymer system that meets
the mechanical characteristics above. Various cross sections of the
flanged catheter other than a simple tubular structure can also be
used such as a solid structure, multi-lumen, or complex geometry
that would provide the mechanical characteristics above. The
coefficient of friction of the surfaces of the flanged catheter may
be inherent to the materials used to construct the device or may be
enhanced through a surface preparation such as a lubricious coating
or mechanical modification of the surface such as longitudinal
recesses.
[0055] In the exemplary case of the flexor digitorum profundus at
the level of the middle phalanx, the flanged catheter may be formed
of silicone and be 120 millimeters in length with a wall thickness
of 0.5 mm, and an outer diameter of 2 mm. However, it is preferred
that the flange portion 159 of the catheter be fabricated of a
thinner cross section material, for example, 0.25 mm or less, that
will allow the flange portion 159 of the flanged catheter to
envaginate the tendon stump and collapse as it tracks through the
anatomical pathway for repositioning of the tendon stump, e.g.,
pulley system of the finger. A softer silicone, for instance, of 20
to 40 durometer (Shore A) is preferred for the flanged
catheter.
[0056] Referring now to FIG. 2A, in use, if the tendon has
retracted and must be retrieved from a first incision 161 into a
second incision (or the wound) 160, as is typical of tendon
lacerations in the hand, an incision 161 is made, typically in the
palm of the hand, where the tendon 153 can be retrieved. If, on the
other hand, the proximal tendon stump is distal to the A2 pulley,
then the tendon would be exposed through an incision just distal to
the A2 pulley. The pulley system of the pinky finger is shown in
FIG. 7 disembodied from the surrounding tissue for sake of clarity.
It comprises five annular pulleys, termed A1 through A5, and three
cruciate pulleys, termed C1, C2, and C3 as shown. The pulley system
is not shown in most other Figures in order not to obfuscate the
invention.
[0057] The pulley catheter 101 is passed into the wound or incision
160 at the laceration site and slowly pushed proximally toward the
new incision 161 beneath the A3 pulley through the pulley system of
the finger. If resistance is encountered such that the pulley
catheter 101 cannot be pushed through proximally, then a 1/2 cm to
1 cm incision (not shown) may be made midway between the skin
creases of the proximal interphalangeal joint of the finger and the
crease at the base of the finger. This is at a level between the A2
pulley and the A3 pulley of the finger. The dissection is carried
down gently to the flexor sheath where the pulley catheter will be
found. The pulley catheter can then be pulled past the obstruction
or resistance through this incision. Then the pulley catheter can
continue to be advanced proximally through the pulley system of the
finger by pushing gently on it until it reaches the tendon
retrieval incision 161 and is exposed proximally.
[0058] Next, as shown in FIG. 2B, the narrow end 157 of the flanged
catheter 103 is connected to the proximal end of the pulley
catheter 101. If the components are sufficiently large and/or the
surgeon is sufficiently dexterous, the narrow end of the flanged
catheter may be inserted directly into the proximal end of the
pulley catheter. Otherwise, a metal dowel 105 or other form of
catheter connector (e.g., a hook) may be used to make the
connection. Particularly, the catheter connector 105 is rigid and
the narrow end 157 of the flanged catheter 103 can be inserted over
one end of the catheter connector. Then, the other end of the
catheter connector 105 can be inserted into a tight friction fit in
the proximal end of the pulley catheter 101 to interconnect the
pulley catheter 101 and the flanged catheter 103.
[0059] Next, with reference to FIG. 2C, the proximal stump 153a of
the tendon is delivered through the incision 161 in the palm so
that approximately 2 cm of the tendon is exposed outside of the
incision 161. (If the proximal tendon stump has retracted only a
short distance and is present at the level of the proximal phalanx,
then the tendon can be delivered through an incision distal to the
A2 pulley or between the A1 and A2 pulleys, as the case may be).
Preferably, a flexible barrier 165 is placed under the tendon
holder 107 and the proximal tendon stump 153a to create a working
`table` for practicing this technique. With the pulley catheter 101
and the flanged catheter 103 attached, the pulley is pulled
distally from incision 160 to draw the flanged catheter 103 into
and through the pulley system between incisions 160 and 161. When
the leading end 157 of the flanged catheter 103 exits through
incision 160 so that the flanged catheter 103 is running between
the two incisions 160, 161, the pulley catheter 101 and connector
105 are removed, as shown in FIG. 2C.
[0060] Turning now to FIG. 2D, the straight needle 111 at the end
of cable portion 144 of the tendon repair device 109 is then placed
in the tendon stump 153a approximately 1 cm from the end 168a of
the stump 153a and the needle 111 is directed out through cut end
168a of the tendon stump 153a. The needle 111 is pulled through
until the sleeve 149 is approximately 1/2 cm from the cut end 168a.
If the tendon exposure is too little, then the sleeve 149 may be
positioned somewhat closer to the cut end 168a.
[0061] Next, a small tenotomy is made in the tendon so that the
crimp can be buried within the tendon. The condition of the tendon
and tendon repair device at this point of the procedure is shown in
FIG. 2D.
[0062] With the tendon repair device 109 in this position, the
seven free strands 147a-147g of the tendon repair device are used
to stitch the tendon repair device 109 to the tendon stump 153a.
More particularly, two of the sutures, e.g., 147a and 147g, are
pushed through the tendon using the curved needles 114a and 114g
and tied to each other in a knot 185. In a preferred embodiment,
the two sutures are stitched to the tendon 153a using a locking
cross stitch or cruciate pattern. In this instance, the loading
will be spread amongst multiple points of fixation along the length
of the repair. Also, due to the cruciate method, under tension, the
repaired tendon would tend to reduce in diameter which would
facilitate traversing through the pulley system. The sutures 147a,
147g are cut at the far side of the knot to remove excess material
beyond the knot. In order not to obfuscate the invention, however,
the stitches are shown in most of the drawings, including FIGS.
2E-2J, representatively as Xs. Only in drawings that are of
suitable scale, such as FIG. 2L, or in which some significant
discussion of the stitches is given in the corresponding text is
the stitching represented more accurately.
[0063] Next, two more sutures, e.g., 147b and 147f, are stitched to
the tendon using the curved needles and 114b and 114f and tied
together in another knot 187. Preferably, the knot 187 is a
crisscross locking stitch with the two limbs traveling proximally.
The sutures are cut after the knot is tied. In a preferred
embodiment of the invention, as shown in FIG. 2E, the first knot
185 and the second knot 187 are tied at different levels along the
length of the tendon stump 153a. Finally, two more sutures, e.g.,
147c and 147e, are tied in a similar crisscross knot (not seen) on
the other side of the tendon stump 153a and cut.
[0064] Finally, the single remaining suture 147d may be cut off or
may be used to couple with any of the other free ends (prior to
trimming) to form yet another knot. It is preferable that there be
multiple points of fixation of the tendon repair device to the
tendon stump.
[0065] In one embodiment of the invention, the sutures can be of
different lengths, organized in pairs, such that each of the two
sutures forming a pair are the same length and each pair of sutures
is of a different length. When stitching the sutures to the tendon,
each pair of sutures of the same length are stitched to the tendon
and knotted to each other. This embodiment is advantageous in that
it provides an easy visual indication to the surgeon which pairs of
sutures are to be tied to each other during the procedure (the
sutures of the same length) thus simplifying the procedure.
[0066] Referring to FIG. 2F, now that the tendon repair device 109
is securely fixed to the proximal tendon stump 153a, the tendon is
removed from the tendon holder and the straight needle 111 at the
end of cable portion 144 is inserted into the flange 159 of the
flanged catheter 103. Tendon repair device 109 is advanced through
the flanged catheter until the end of the tendon stump 153a (which
is stitched to the back end of the tendon repair device 109) is in
the flange portion 159 of the flanged catheter 103. Cable portion
144 preferably is rigid enough that the cable can be pushed along
with the flanged catheter through the pulley system of the finger
and follow the flanged catheter 103 out of the wound 160. Now the
surgeon can grasp the needle 111 through the flanged catheter 103
with a clamp and pull the needle 111, cable portion 144, flanged
catheter 103 and tendon stump 153a (contained inside collapsible
flange 159 of flanged catheter 103), through the pulley system of
the finger and out of the wound 160. Alternately, if the needle 111
protrudes from the distal end 157 of the flanged catheter, the
surgeon can grasp the needle 111 or cable portion 144 directly by
hand or with a clamp and pull the needle 111, cable portion 144,
flanged catheter 103, and tendon stump 153a (contained inside
collapsible flange 159 of flanged catheter 103), through the pulley
system of the finger and out of the wound 160. If any resistance is
encountered, then the path through the pulley system can be
inspected through a separate incision.
[0067] The flange 159 of the flanged catheter 103 will collapse
around the tendon stump as needed to pass through the pulley system
of the fingers.
[0068] Referring to FIG. 2G, once the tendon stump 153a has reached
the wound 160, flanged catheter 103 can be removed from the tendon
repair device 109 and tendon stump 153a, thereby exposing the
tendon repair device 109 and tendon stump 153a through the wound
160. Needle 205 of tendon holder 107 can be placed across the
proximal tendon stump 153a to hold the tendon stump 153a in a
stable position.
[0069] In FIG. 2G and subsequent drawings, the length of the tendon
stump(s) may be exaggerated to help with the illustration of the
repair. However, it should be understood that, once the tendon has
been retrieved to or near the original wound site (as in FIG. 2G),
there is little or no excess tendon to expose outside of the skin,
especially if the finger is in an open (i.e., unflexed) condition.
In actuality, if the finger is unflexed, the surgeon will probably
be working on the tendon primarily within the skin. However, in
some of the drawing figures, the length(s) of the tendon stump(s)
may be exaggerated in order not to obscure the illustration of the
methods and apparatus being described in connection therewith.
Furthermore, in some of the drawings in which the stitches are not
substantially related to the features being discussed in connection
therewith, the stitches and/or knots are represented by a simple
criss-cross pattern in order not to overly complicate the drawings.
In other drawings in which the stitching or knots are more closely
related to the features being the discussed, a more accurate
representation of an appropriate knot/stitch is presented.
[0070] It also should be noted that other features, such as the
diameters or lengths of the sutures, crimps, crimp connectors, and
needles, are not necessarily drawn to scale in all of the
figures.
[0071] Next, referring to FIG. 2H, a very similar procedure is
performed with respect to the distal tendon stump. Particularly,
the distal tendon stump 153b is delivered into the wound 160 in a
similar fashion as described above in connection with the proximal
tendon stump 153a. That is, if adequate exposure is not possible to
retrieve the distal tendon stump 153b directly from the wound 160,
a 1 cm incision 174 may be made just distal to the crease at the
distal interphalangeal joint and dissection carried down onto the
distal extent of the A5 pulley so that the distal tendon stump 153b
can be exposed through this new incision. The pullet catheter 101
is guided between the incisions 160, and 174 and the flanged
catheter 103 is inserted into the distal end of the pulley catheter
101. The pulley catheter 101 is then pulled through the pulley
system with the flanged catheter 103 following it until the flanged
catheter 103 is positioned through the pulley system and extending
at opposite ends from incision 160 and 174, as shown in FIG. 2H.
Next, another tendon repair device 109 is attached to the distal
tendon stump 153b in the same manner as described above in
connection with the proximal tendon stump. FIG. 2H illustrates the
procedure at this stage.
[0072] Referring next to FIG. 2I, the distal tendon stump is next
guided to the original wound site 160 using pulley catheter 101 and
the flanged catheter 103 as described above in connection with the
proximate tendon stump 153a. The second needle 207 of the tendon
holder 107 may be placed through the distal tendon stump 153b,
exposing approximately 1 cm of tendon as described above in
connection with the proximal tendon stump. This stage of the
procedure is illustrated in FIG. 2I.
[0073] Next, referring to FIG. 2J, the connector 112 is brought to
the site and the straight needles 111 at the ends of the cable
portions 144 are inserted through the bores 151, 152 in the
connector 112. More particularly, the straight needle 111 of the
tendon repair device 109 that is attached to the proximal tendon
stump 153a is passed through one of the bores 151 traveling in the
proximal-to-distal direction and the straight needle 111 of the
tendon repair device 109 that is attached to the distal tendon
stump 153b is passed through the other through bore 152 in the
connector traveling in the opposite direction, i.e., from the
distal-to-proximal direction.
[0074] Referring now to FIG. 2K, the proximal and distal tendon
stumps 153a, 153b are removed from their respective tendon holder
needles (and the tendon holder is put aside) and traction is
applied to pull the distal tendon stump 153b proximally and pull
the proximal tendon stump 153a distally until there is overlap of
the two tendon stumps of approximately 1 mm, with the connector 112
essentially buried in tendon between the tendon ends 168a,
168b.
[0075] A crimping tool 113 is then used to crimp the connector 112,
thereby securely affixing the cable portions 144 of the two tendon
repair devices inside of the connector 112. More particularly, with
reference to FIG. 2K, the tendon stumps 153a, 153b can be folded
back slightly to expose the connector 112 so that the crimping tool
113 can be placed over the crimp connector without contacting or
damaging the tendon.
[0076] Alternatively, if necessary, the tendon holder 107 can be
used to help bring or hold the tendon stumps together by adjusting
the positions of the two needles 205, 207 in the slots 209, 211 of
the tendon holder 107 towards the center so that they are very
close to each other and piercing each tendon stump with one of the
needles.
[0077] The extra lengths of cable portions 144 extending from the
connector 112 are then cut as close to the edge of the crimp
connector as possible and discarded. The connector 112 will then
retract into the substance of the tendon when it is released and
the tendon ends are unfolded and there will be excellent cooptation
of the tendon ends, as illustrated in FIG. 2L. FIG. 2L represents
four cruciate stitches 185, 187, 185', and 187' made using the
tendon repair devices. While cruciate stitches are believed to be
particularly efficacious, other types of stitches can be used as
well. If desired, one or more 6-0 nylon epitendonous stitches 183
can be placed around the tendon ends to assure good cooptation of
the tendon ends in order to `tidy up` the edges of the repair.
[0078] FIG. 3 is a photograph of an actual tendon repair performed
in accordance with the first embodiment of the invention. The first
and second knots 185 and 187, respectively, can be seen in the
proximal tendon stump 153a. Similar knots 185' and 187' are seen in
the distal tendon stump 153b. Four epitendonous stitches 183 also
can be seen.
[0079] The one or more skin wounds can be stitched closed as usual
and the procedure is ended.
[0080] While the procedure and apparatus has been described above
in connection with one particular procedure relating to the repair
of a flexor tendon laceration, flexor digitorum profundus at the
level of the middle phalanx, this is merely an exemplary
application. The invention can be applied to reattach other types
of tendons, ligaments, or other similar load-bearing soft
tissues.
Second Set of Exemplary Embodiments
[0081] FIGS. 4A-4D illustrate another apparatus and procedure in
accordance with the principles of the present invention that can be
used in situations where the tendon (or ligament) has avulsed or
otherwise been separated from the bone, rather than severed. The
apparatus and procedure described in connection with FIGS. 4A-4D
also may be used in situations where the tendon or ligament has
been severed very close to the bone so that there is not enough
tendon length left to effectively attach a tendon repair device 109
to that stump.
[0082] In these types of situations, a tendon repair device such as
the afore-described tendon repair device 109 is still used in the
manner described above in connection with FIGS. 2A-2H in connection
with the stump that has sufficient length, e.g., at least 2 cm,
(typically the proximal stump). However, with respect to the bone
or short tendon stump, one or more cables are attached directly to
a bone anchor 400 instead of using a second tendon repair
device.
[0083] The bone anchor may be any bone anchor that can be attached
to bone at its distal end and to which a suture or cable can be
attached to the proximal end thereof. Suitable bone anchors are
disclosed, for instance, in PCT International Published Patent
Application WO 2008/054814, which is incorporated herein by
reference. However, much simpler bone anchors can be used also.
[0084] In a simple embodiment of a suitable bone anchor, such as
illustrated in FIG. 1, the bone anchor may comprise a threaded
distal portion 401 for threading into bone and an eyelet 402 for
receiving the cable of the tendon repair device integrally formed
in the proximal portion of the bone anchor main body. In other
embodiments, the bone anchor may be prefabricated with one or more
sutures integrally formed therein and extending from the proximal
end thereof.
[0085] A surgical procedure in accordance with this embodiment will
now be described in connection with an exemplary injury in which
the flexor digitorum profundus has been lacerated very close to the
distal phalanx. However, it should be understood that variations of
this procedure can generally be used in connection with any tendon
or ligament that has avulsed from the bone or been severed close to
the bone.
[0086] FIGS. 4A-4D illustrate various stages of an exemplary
procedure for effecting a four strand repair (i.e., the repair will
have four suture strands running between the two tendon stumps).
This embodiment utilizes a different tendon repair device 1001 than
the tendon repair device 109 illustrated in FIGS. 1-2L. This tendon
anchor is illustrated in FIG. 10A, which is discussed in more
detail below in connection with another exemplary surgical
procedure. With reference to FIG. 10A, it comprises two strands or
filaments 1047a, 1047b, with each strand having a needle at each
end. In the illustrated embodiment, curved needles 1014a and 1014b
are provided at the first ends of the strands 1047a, 1047b,
respectively, and straight needles 1011a, 1011b are provided at the
second end of the strands 1047a, 1047b, respectively. The two
strands comprising the tendon repair 1001 device are joined
intermediate their ends, such as by a fixed or slidable crimp 1049.
The crimp 1049 may initially be uncrimped so that it can slide
along the device and, if desired, crimped at a suitable stage of
the procedure. As shown in FIG. 10A, the tendon repair device 1001
may be delivered to the surgeon with a portion of the sutures and
the straight needles 1011a, 1011b on end 1001a enclosed in a sheath
1011 to ease the process of passing that end of the tendon repair
device 1001 into the pulley catheter 101 and/or flanged catheter
103.
[0087] The long tendon stump 501 is operated upon essentially as
described above in connection with the first embodiment.
Particularly, with reference to FIG. 4A, the tendon stump 501 is
retrieved, if necessary, by making a retrieval incision 531 where
needed, exposing the tendon stump 501, and stitching end 1001b of
the tendon repair device 1001 to the tendon stump using the curved
needles. In this exemplary case, where there are only two sutures
1047a, 1047b, one cruciate stitch is preferred. In embodiments
using tendon repair devices having more sutures, such as the tendon
repair device 109 of FIGS. 1-2L having seven sutures, then the
tendon repair device can be stitched to the tendon stump using
multiple cruciate or other stitches, exactly as described above in
connection with the embodiment of FIGS. 1-2L, for instance. Next,
the pulley catheter 101, flanged catheter 103, and catheter
connector 105 (if needed) can be used as previously described to
guide the tendon repair device 1001 and tendon stump 501 back to
the injury site 533. The narrow sheath 1011, if provided, will
facilitate threading of the end 1001a of the tendon repair device
1001 into and through the catheters.
[0088] Then, the tendon stump 501 is placed in a tendon holder 107
while the distal tendon stump is prepared. FIG. 4A shows the
condition of the surgical site after these steps have been
performed, i.e., with the tendon 501 in a tendon holder 107 with a
tendon repair device 1001 stitched thereto.
[0089] Next, referring to FIG. 4B, with respect to the bone 503
(and distal stump 505, if any is present), an incision 532 (which
may include original injury 532) is made and dissection is carried
down to expose the bone 503 of the distal phalanx. A bone anchor,
such as bone anchor 450 shown in FIG. 1, is then affixed to this
bone 503 by screwing it in securely.
[0090] Next, with reference to FIG. 4C, since this exemplary
embodiment is a four strand repair, two of the sutures 451c, 451d
of the bone anchor 450 can be cut off at or as close to the bone
anchor as possible. The other two sutures 451a, 451b are threaded
through the distal stump 505. Now, referring to FIG. 4D, the tendon
stumps are brought together with a slight amount of overlap and the
two sutures 451a, 451b of the bone anchor 450 are stitched and
knotted to the proximal stump 501. Likewise, the tendon repair
device 1001 that is already stitched to the proximal tendon stump
501 at one end thereof is then stitched to the distal stump 505 at
the other end. FIG. 4D shows the completed repair in accordance
with this embodiment.
[0091] Of course, the number of strands on the bone anchor 450 and
the number of strands on the tendon repair device 1001 can be
increased to provide a stronger repair, such as a six eight, ten,
or even twelve strand repair, if desired.
[0092] A tendon injury of the type illustrated in FIGS. 4A-4D, in
which there is only a short distal tendon stump remaining (or none
at all) also can be repaired using a tendon repair device 109 such
as illustrated in FIGS. 2A-2L and the other bone anchor 400 shown
in FIG. 1, the long tendon stump 501 is operated upon exactly as
described above in connection with the first embodiment of FIGS.
2A-2L. Particularly, the proximal tendon stump 501 is retrieved, if
necessary, by making a retrieval incision where needed, exposing
the tendon stump 501, attaching a tendon repair device 109 to the
tendon stump, and using the pulley catheter 101, flanged catheter
103, and catheter connector 105 (if needed) as previously described
to guide the tendon stump back to the injury site.
[0093] Next, an incision is made and the bone anchor 400 is affixed
to the bone essentially as described above in connection with FIGS.
4A-4D, expect that it is bone anchor 400, rather than bone anchor
450.
[0094] Next, if a distal stump of the flexor is still present, such
as stump 505 in FIGS. 4A-4D, then the needle 111 and cable 144 of
tendon repair device 109 is run through this stump 505 and into and
through the eyelet 402 of the bone anchor 400. Particularly, the
straight needle 111 at the end of cable portion 144 is brought into
the short distal tendon stump 505 through the severed end of the
tendon stump 505 and out through the side of the tendon stump near
where the stump 505 is still attached to the bone 503 and then
through the eyelet 402 in the bone anchor 400.
[0095] Next, traction is applied to the cable 144 to draw the
proximal tendon stump 501 distally until there is a 1 mm overlap of
the proximal tendon stump 501 with the distal tendon stump 505.
[0096] Then, the cable 144 is fixed to the eyelet of the bone
anchor 503. This can be done by tying the suture or cable to the
eyelet 402 of the bone anchor. In a more preferred embodiment,
however, the proximal end of the bone anchor 503 is crimped to
crush the eyelet 402 of the bone anchor 400, thereby trapping the
cable 144 therein.
[0097] Finally, the procedure is completed essentially as described
above in connection with the embodiment of FIGS. 2A-2L or
4A-4D.
[0098] If, on the other hand, there is no or virtually no distal
tendon stump remaining to attach to, the proximal stump would
instead be attached directly to the bone using the bone anchor.
Preferably, the cable portion 144 of the tendon repair device
attached to the tendon stump is directly attached to the bone
anchor without the use of a second suture or cable 509 and the
proximal tendon stump is pulled distally so that the stump
envelopes the bone anchor and contacts the bone around the bone
anchor. As is often the case, the surgeon may roughen, counter bore
or tunnel the bone in the area around the bone anchor for the
tendon to attach to.
[0099] In another alternate embodiment, only the bone anchor 450
with multiple strands (with needles at the ends of the strands)
already extending from the bone anchor is used. No separate tendon
repair device 109 or 1001 is used. Rather, the sutures extending
from the bone anchor 450 are stitched directly to the proximal
tendon stump. This type of embodiment is most suited to an injury
in which (1) the proximal tendon stump has not retracted
significantly and is, therefore, present at the incision near the
distal stump without the need to be retrieved through another
incision and (2) there is no distal tendon stump to include in the
repair. Particularly, with respect to the first point, if the
proximal tendon stump needs to be retrieved, then it would likely
be more practical to use the technique described in connection with
FIGS. 4A-4D. More specifically, if the proximal tendon stump must
be retrieved, then a separate tendon repair device probably will
have to be attached to the proximal tendon stump for purposes of
retrieving the stump, in any event. In such a situation, it would
be simpler to attach the tendon repair device that is already
stitched to the proximal tendon stump to the bone anchor than to
add another set of sutures.
[0100] With respect to the second point, if there is a distal
tendon stump, it would be preferable to include sutures emanating
from the proximal stump that exert a force pulling the distal
tendon stump toward the proximal tendon stump. In the absence of a
proximal tendon repair device, no sutures exerting such a force
would be present and, therefore, the distal tendon stump could
conceivably slide away from the end to end contact of the two
tendon stumps prior to healing of the tendon stumps.
[0101] In repairs in accordance with the bone anchor embodiment,
the load on the distal end is borne completely by the bone and bone
anchor.
[0102] Preliminary testing has shown failure strengths of tendon
reattachments performed in accordance with the principles of the
present invention of approximately 70-100 Newtons. Accordingly, a
tendon and ligament repair in accordance with the principles of the
present invention results in a much stronger repair that the
current standard of care.
[0103] In addition, the procedure is greatly simplified as compared
to the present standard of care.
Third Set of Exemplary Embodiments
[0104] FIG. 5 illustrates another embodiment in accordance with the
principles of the present invention. FIG. 5 is a close up of the
proximal tendon stump 153a in accordance with this embodiment of
the invention at a stage after the tendon repair device 109 has
been stitched to the tendon stump. It is essentially similar to the
stage shown in FIG. 2E, but illustrating a different way to finish
off the stitches other than tying them in knots in pairs.
[0105] This embodiment involves a simpler procedure than in the
aforedescribed embodiment in so far as the surgeon will not be
required to tie any knots. Rather, as shown in FIG. 5, rather than
tying knots in the sutures 147a-147g after stitching them to the
tendon, a crimp 603 can be advanced over each suture against the
stitch as far as it will go and then crimped with a crimping tool
to lock the crimp to the suture, thus locking the stitch to the
tendon. Depending on the particular configuration of the curved
needles 114a-114g and the crimps 603, the crimps may be slipped
over and around the needles onto the sutures 147a-147g. If this is
not possible, then the needles 114a-114g can be cut off of the
sutures 147a-147g after the corresponding stitch is tied to permit
the crimp to be placed on the suture. In this embodiment, the
surgeon is not required to tie any knots with the sutures, thus
simplifying the procedure. The surgeon is free to use the sutures
to create any stitches desired, but they do not need to be knotted
at the end.
Fourth Set of Exemplary Embodiments
[0106] FIGS. 6A and 6B illustrate an alternative to the crimp
connector 115 for attaching two tendon repair devices 109 (or a
tendon repair device 109 and a bone anchor 115) to each other. In
this embodiment, the connector 701 comprises a connector main body
711 having two parallel, longitudinal through bores 713, 715. The
main body 711 may be cylindrical, rectangular, or any other
reasonable shape. Another bore 717 is provided in the main body 711
transverse to the direction of longitudinal through bores 713, 715,
this bore intersecting the two longitudinal through bores 713, 715.
A pin in the form of a block 719 fits in the transverse bore 717.
Accordingly, when the block is inserted in the transverse bore 717
as shown in FIG. 6b, it also transversely passes through portions
of the longitudinal through bores 713, 715. The dimensions of the
block 719, the transverse bore 717 as shown in FIG. 6B, the
longitudinal through bores 713, 715, and cable portions 144 (that
will pass through the longitudinal through bores 713, 715) are
chosen so that the block 719, when inserted into the transverse
bore 717 will compress the cables in the longitudinal bores 713,
715 between the side wall of the block 719 and the side walls of
the longitudinal bores 713, 715, thereby trapping the cables in the
connector 701.
[0107] Thus, in this embodiment, rather than crushing the crimp
connector with a crimping tool, a pliers or clamp type tool acts on
the block 719 and the connector 701 and pushes the block 719 into
the connector 701 against the resistance of the cable portions 144
in the longitudinal through bores 713, 715, thereby capturing the
cables as described above.
[0108] Some of the advantages of this embodiment of the connector
include a much lower force requirement for locking since the block
719 does not have to be plastically deformed. Rather, this
mechanism relies on the wedging of cables 144 against the inner
wall of connector 701 to effect the lock.
[0109] There are many possible alternative stitching techniques to
the few described above. The present invention can accommodate and
permit the surgeon to use any stitching technique desired. In
alternate embodiments, the tendon repair device may have only four
sutures or, if it has more than four sutures, the surgeon may
decide to cut off those sutures that he or she does not use. For
instance, two of the sutures of the tendon repair device 109 of
FIGS. 1-2L, e.g. sutures 147a and 147g, may be stitched to the
tendon using cross stitches and are knotted together as previously
described in connection with the embodiment of FIGS. 2A-2L, except
that the remaining distal portions of the sutures 147a, 148g
extending from the knots are not cut off at this time. Next,
another two sutures, e.g., 147b, 147f, are stitched to the tendons
at a different level than the first two sutures and knotted, also
as described in connection with the embodiment of FIGS. 2A-2L.
Then, sutures 147a and 147b are tied in a knot and sutures 147g and
147f are tied in another knot. Now, the distal ends of each of
sutures 147a, 147g, 147b, and 147f may be cut off. The other 3
sutures 147c, 147d, 147e, may be cut off and not used or may be
used to form other knots. The inter-dependence of the two pairs of
sutures in this technique provides greater assurance that the
sutures will not tear out of the tendon.
[0110] In yet other embodiments, the third pair of sutures also may
be tied together with the first two pairs of sutures. The various
permutations of stitching techniques and tying together of the
sutures are virtually endless.
Sixth Set of Exemplary Embodiments
[0111] FIG. 8A illustrates an alternative embodiment of the tendon
repair device. This embodiment is particularly suited to, but not
limited to, surgical procedures in which either one or none of the
tendon stumps needs to be retrieved from a separate incision and be
guided back to the wound site. This embodiment also has the
advantage of being capable of effecting a repair using only a
single tendon repair device, if desired.
[0112] As can be seen in this embodiment, rather than having one
side of the anchor comprised of multiple sutures and the other side
comprised of one cable as was the case for the embodiments
illustrated in FIGS. 1-2L and 4A-4E, this tendon repair device has
multiple sutures on both sides 901a, 901b of the tendon repair
device 901. More particularly, this tendon repair device may be
formed of four sutures 947a-947d attached together at one or more
intermediate points along their lengths. In one embodiment that is
particularly convenient to manufacture, the tendon repair device
901 comprises four sutures 947a-947d with at least one crimp 949
intermediate their lengths holding them together. The crimp may be
initially uncrimped so that it can slide along the lengths of the
sutures during the procedure. It may be crimped to lock its
position relative to the sutures at any point during the procedure.
In some procedures, it may not be crimped at all.
[0113] In this embodiment, the tendon repair device 901 preferably
is delivered to the surgical site in the condition illustrated in
FIG. 8B, i.e., with at least one of the side 901a contained in a
narrow sheath 911 (e.g., a plastic tube) that can be easily passed
through the flanged catheter. However, depending on the diameters
of the needles, sutures, flanged catheter, the number of sutures in
the device, and the material of the flanged catheter, a sheath may
be unnecessary or may cover only part of the end 901a (such as just
the tips of the needles 913a-913d). In this embodiment, the needles
913a-913d attached to the ends of the sutures on side 901a of the
crimp 949 that will be placed in the sheath 911 should be straight
needles in order to more readily fit into the sheath 911 and/or
through the catheters 101, 103. The needles attached to the other
ends of the sutures 947a-947d may be curved needles 914a-914d to
facilitate stitching. However, they also may be straight
needles.
[0114] The first half of the surgical procedure is essentially
identical to the procedure described above in connection with the
first embodiment illustrated in FIGS. 2A through 2L. More
particularly, the procedure is essentially identical to that
embodiment up to the stage illustrated in FIG. 2F, the only
difference being that, instead of a single cable 144 extending from
the far side of the intermediate crimp 949, there are four
individual sutures (or cables) contained in a sheath 911.
[0115] After the device has been stitched to one tendon stump, the
sheath 911, containing the four straight needles and sutures is
traversed through the pulley system to the site of the wound as
described previously. Next, the protective sheath 911 is removed;
thereby releasing the four sutures 947a-947d and straight needles
913a-914d.
[0116] In one embodiment, the sheath 911 is cut with a knife or
scissor. In another embodiment, the sheath can be torn by hand. In
yet another embodiment, and, particularly, the illustrated
embodiment, the sheath 911 comprises an integral longitudinal strip
911a, such as a string embedded within the material of the sheath,
having a "tail" 911b extending beyond at least one end of the
sheath so that it can be grasped by the surgeon and pulled to tear
the sheath, thus freeing the needles for attachment to the tendon
stump. Alternately, the strip may comprise a weakened radial
segment of the sheath running the full longitudinal length of the
sheath. The weakened segment may comprise a strip of the sheath
that is integrally formed with the rest of the sheath, but having a
thinner wall thickness than the rest of the sheath.
[0117] The crimp 949 may be crimped at this stage of the procedure
to lock its position on the device 901. For instance, it may be
crimped immediately adjacent the end of the tendon stump 902a to
which it has been stitched at this point.
[0118] When using this embodiment, the other tendon stump 902b
preferably is exposed at the wound site without the need to be
retrieved. If, however, it must be retrieved through a different
incision, it can be retrieved using any reasonable technique,
including conventional techniques for tendon retrieval or using the
pulley catheter and flanged catheter of the present specification
as described above. For instance, a small suture can be stitched to
the tendon temporarily and the suture can be advanced through the
pulley system of the finger using the pulley catheter 101 and
flanged catheter 103 much as described above in connection with the
first embodiment.
[0119] In any event, with the other tendon stump 902b exposed at
the wound, the two stumps 902a, 902b are positioned with their ends
opposed to each other and the second end 901a of the tendon repair
device can be stitched to the distal tendon stump 902b much in the
same way as described above in connection with the first
embodiment. Care should be taken to assure that the two tendon ends
902a, 902b oppose each other, since it will be difficult, if not
impossible, to adjust the relative positions of the ends of the
tendon stumps after the first stitch is completed and locked. The
tendon holder 107 can be used as previously described to hold the
tendon ends opposed to each other. The sutures may be stitched to
the tendon in pairs as previously described. The repair can be
completed with an epitendonous stitch between the two stumps as
previously noted.
[0120] This embodiment is advantageous in that it requires no crimp
connector or crimping tool and has fewer parts. For example, only
one tendon repair device is involved in the procedure, that tendon
repair device being double headed, as shown in FIG. 8A.
Seventh Set of Exemplary Embodiments
[0121] FIGS. 9A-9C help illustrate yet another embodiment of a
tendon repair device and technique particularly suited, but not
limited, to repairs where both tendon stumps must be retrieved to
the repair site by being tracked through anatomy between two
incisions. FIG. 9A shows the tendon repair device 951 in accordance
with this embodiment. In this embodiment, two tendon repair devices
951 are used, each comprising two strands or filaments 953a, 953b,
with each strand having a needle at each end. In the illustrated
embodiment, curved needles 954 are provided at the first end and
straight needles 955 are provided at the second end of each strand.
The two strands comprising a single tendon repair device are joined
intermediate their ends, such as by a slidable crimp 956 as
previously described in connection with other embodiments. The
crimp 956 may initially be uncrimped so that it can slide along the
device and, if desired, crimped at a suitable stage of the
procedure.
[0122] As shown in FIG. 9B, one end 951a of each tendon repair
device 951-1, 951-2 is stitched to a respective tendon stump 961a,
961b using the two strands of that end. The other end 951b of each
tendon repair device may be initially encased within a sheath 968
similarly to the embodiment of FIGS. 8A and 8B for purposes of
being passed through anatomy, such as the pulleys of the finger,
using the pulley catheter and flanged catheter described above in
connection with other embodiments. However, as noted above in
connection with the embodiments of FIGS. 8A and 8B, the sheath may
not be necessary.
[0123] Next, the tendon repair devices and tendon stumps to which
they are stitched can be tracked through anatomy to the repair
incision using the pulley and flanged catheters as previously
described. The condition of the tendon repair procedure at this
point is illustrated in FIG. 9B. Referring now to FIG. 9C, the two
tendon stumps 961a, 961b are brought together. If desired, they can
be held in position using the tendon holder 107, with one needle
205,207 in each of the tendon stumps 961a, 961b (not shown).
[0124] Next, the free ends 951b of the two strands of the first
tendon repair device 951-1 (the other ends 951a of which are
already stitched to the first tendon stump 961a) are stitched to
the second tendon stump 961b, preferably at a different level than
the stitches of the second tendon repair device 951-2. Likewise,
the free ends 951b of the two strands of the second tendon repair
device 951-2 (the other ends 951a of which are already stitched to
the second tendon stump 961b) are stitched to the first tendon
stump 961b. The completed repair is shown in FIG. 9D. The repair
can be completed with an epitendonous stitch as previously
described, if desired.
[0125] Like the embodiment of FIGS. 8A-8B, this embodiment provides
four strands running between the two tendon stumps, and two
stitches at different levels in each tendon stump, thereby
providing a very sturdy repair.
Eighth Set of Exemplary Embodiments
[0126] FIG. 10A illustrates a tendon repair device in accordance
with yet another embodiment of the invention. This device 1001 is
essentially the same device of FIG. 9A, but with one side in a
sheath, as will be described in more detail below. In these
embodiments, two tendon repair devices will be used, as in the
first embodiment as illustrated in FIGS. 1 and 2A-2L. However, both
of these tendon repair devices 1001 have multiple strands at each
end, as in the embodiments illustrated in FIGS. 8A-8B and 9A-9D.
More particularly, each tendon repair device 1001 comprises two
sutures 1047a, 1047b. The two sutures may be coupled together
intermediate their ends, such as by a crimp 1049 or sliding sleeve.
Alternately, the two sutures may be independent of each other.
[0127] Even further, the tendon repair device 1001 may comprise a
single cable or suture over much of its length and be broken out
into two sutures only near the opposite ends of the anchor. Again,
such a tendon repair device may be formed of two sutures twisted
together over much of their length and separated near the opposite
ends with a crimp, such as crimp 956, at each end of the twisted
portion holding the twisted portion together. As in the embodiment
of the tendon repair device illustrated in FIGS. 8A-8B and 9A-9D,
straight needles 1013a, 1013b preferably are employed on at least
one end 1001a of the device 1001 and curved needles 1014a, 1014b
are employed on the other end 1001b. As shown, the tendon repair
device may be delivered to the surgeon with the sutures and
straight needles 1011a, 1011b on end 1001a enclosed in a sheath
1011. The procedures and apparatus for repairing a tendon using
this embodiment of the tendon repair device are rather similar to
those described previously in connection with the first and second
embodiments. Particularly, one or both of the tendon stumps can be
retrieved through the pulley system of the finger, as needed,
exactly as described in connection with the first embodiment of the
invention illustrated in FIGS. 1 and 2A-2L, except that only two
sutures are stitched to each tendon stump at one side 1001b of the
tendon repair device 1001.
[0128] In this embodiment two of the tendon repair devices 1001-1
and 1001-2 are used. One side 1001a of each tendon repair device
1001-1 and 1001-2 is stitched to one of the tendon stumps.
[0129] FIG. 10B helps illustrate how two of these fixation devices
1001 could be used to effect a repair by looping them around each
other in accordance with this embodiment of the invention.
Generally, one tendon repair device 1001-1 would be folded to form
a loop 1091 and stitched to the first tendon stump 1087a and the
other tendon repair device 1001-2 would be folded to form another
loop 1092 and embedded in the other tendon stump 1087b with the
loops joined in the middle as described in detail below.
[0130] Specifically, the two sutures 1047a, 1047b and curved
needles 1014a, 1014b on one side 1001b of first tendon repair
device 1001-1 would be stitched to the first tendon stump 1087a
with the other side 1001a of the device sticking out of the end of
the respective tendon stump, basically as described in connection
with previous embodiments.
[0131] Next, with reference to FIG. 10B, the other side 1001a of
the first tendon repair device 1001-1 is returned back into the
tendon same stump through the end of the stump so that the tendon
repair device 1001-1 forms a loop 1091 sticking out of the end of
the tendon stump 1087a. This may be performed by individually
threading each of the two sutures and straight needles 1014a, 1014b
back through the end of the tendon stump 1087a and pulling them out
through the side of the tendon stump. The suture(s) should be
pulled through so that the loop 1091 protrudes from the end of the
tendon stump 1087a by 1 millimeter or less. Preferably, the sutures
are pulled through so that the loop 1091 does not protrude at all,
but is essentially in the substance of the tendon stump 1087a.
Then, the two sutures 1047a, 1047b are stitched to the tendon
essentially as described above in connection with the previously
described embodiments. At this point, both ends 1001a, 1001b of the
tendon repair device 1001-1 are stitched to the tendon stump 1087a
and a loop 1091 is located at the severed end of the tendon stump
1087a.
[0132] Next, the second tendon repair device 1001-2 is attached to
the second tendon stump 1087b in essentially the same manner as the
first tendon repair device 1001-1 was attached to the first tendon
stump 1001a, except that, after the first two needles 1013a, 1013b
at the first end of the 1001a anchor 1001-2 are stitched to the
tendon, the other two needles 1014a, 1014b and sutures 1047a, 1047b
are guided through the loop 1091 formed by the first tendon repair
device 1001-1 to form a second loop 1092 before being stitched to
the second tendon stump 1087b. If the loop 1091 of the first tendon
repair device 1001-1 is within the substance of the first tendon
stump 1087, the substance of the first tendon stump may need to be
retracted with a suitable retractor tool to expose the loop
momentarily for the second tendon repair device needles and sutures
to be passed through the loop. Alternately, the surgeon may simply
pierce the tendon substance with the second tendon repair device
1001-2 to access the loop 1091. Then the two sutures and needles
1014a, 1014b at the second end 1001b of the second tendon repair
device 1001-2 are stitched to the second tendon stump. This
embodiment offers another technique for providing a four strand
repair between the two tendon stumps.
Ninth Set of Exemplary Embodiments
[0133] FIGS. 11A-11E illustrate alternate embodiments and
associated techniques to be used therewith, which techniques can be
used in conjunction with some or all of the features and aspects of
many of the other embodiments of both the methods and apparatus
disclosed herein. FIG. 11A is a perspective view of the apparatus
in accordance with this alternate embodiment. Particularly, in this
embodiment the flanged catheter is replaced with a guidance member
in the form of a funnel 1101.
[0134] In a preferred embodiment, funnel 1101 is formed of a
biocompatible material, such as a biocompatible plastic, that is
relatively rigid, so that it is not easily collapsible. The funnel
1101 comprises a small opening 1102 at one end and a large opening
at the other end 1103. Funnel 1101 defines a frustoconical surface
when in an unbiased condition, but is split along its entire
length, whereby it can be radially spread apart at the split 1104
to resiliently deform the funnel to provide a lateral gap at the
split 1104 through which a tendon, ligament or the like can be
inserted into the funnel. Alternately, the funnel may overlap
somewhat at the split as long as it can be spread apart radially to
provide a lateral opening.
[0135] The small opening 1102 should be smaller than the entrance
to the anatomical passage in connection with which it will be used
for introducing a tendon therethrough and the large opening 1103 is
larger than the anatomical passage. For instance, in the various
embodiments of the invention discussed above in connection with a
repair of a finger tendon, the small opening should be sized to
help facilitate entry into the pulleys of a finger. The large
opening at the other end 1103 of the funnel 1101 should be
sufficiently large to readily accept the end of a tendon stump with
a tendon repair device stitched thereto. A handle 1197 can be
provided extending from the side of the funnel 1101 to facilitate
easy manipulation by the surgeon.
[0136] FIGS. 11B-11D illustrate a surgical technique using the
funnel 1101. With reference to FIG. 11B, a pulley catheter 103 is
positioned through the pulley system of the finger between two
incisions 1112, 1113, as previously described, and a tendon repair
device 1114, which could be any of the tendon repair devices
previously discussed herein, is attached to the end of the proximal
tendon stump 1116. Furthermore, the leading end 1114a of the tendon
repair device 1114 is passed into the pulley catheter 101 also
essentially as previously described, except without the use of a
flanged catheter 103, the function of which will essentially be
replaced by the funnel 1101, as described in detail below.
[0137] In this embodiment, the leading end 1114a of the tendon
repair device 1114 is pushed through the pulley catheter 101 to a
point where the end of the tendon stump 1116 is close to, but not
touching the trailing end 101b of the pulley catheter 101. Next,
the pulley catheter 101 and tendon repair device 1114 are pulled
distally through the pulley system of the finger from the distal
incision 1113 to a point where the trailing end 101b of the pulley
catheter 101 passes the entrance of the first pulley 1121 that must
be traversed, but the tendon stump 1116 is near the entrance to the
pulley 1121, but has not passed it yet. Specifically, as previously
noted, the end of the tendon stump 1116 is deformed and enlarged
and is unlikely to pass easily through the pulley 1121 without a
structure to compress it and guide it in. In the previously
discussed embodiments, that structure was the flanged catheter 103.
In this embodiment, it will be the funnel 1101.
[0138] Thus, with reference to FIG. 11C, funnel 1101 is spread
apart and slipped over the tendon stump 1116 with the small end
1102 of the funnel facing the entrance to the pulley 1121 and the
large end 1103 facing away from the entrance to the pulley. More
particularly, the surgeon positions the funnel 1101 in the entrance
to the pulley 1121 in order to dilate the pulley 1121 and
facilitate the tendon's entering into and passing through the
pulley, as shown in FIG. 11C. Funnels of different sizes may be
provided as part of a kit in order to accommodate different sized
parts of the anatomy and/or different sized patients and to
facilitate dilation of the pulley (or other anatomical
feature).
[0139] With the funnel in the position shown in FIG. 11C, the
surgeon can then pull on the leading end 1114a of the tendon repair
device 1114 to draw the end of the tendon stump 1116 into and
through the funnel 1101 and the pulley 1121.
[0140] It should be apparent that the primary issue addressed by
the funnel 1101 (as well as the flanged portion 159 of the flanged
catheter 103 disclosed in connection with previous embodiments) is
that often, if not always, the end of the tendon stump with the
trailing end of the tendon repair device attached thereto bunches
up to become larger than the passageway through the pulley and
therefore difficult to insert into and through the pulley. The
funnel (as well as the flanged portion 159 of the aforedescribed
flanged catheter 103) contains the end of the tendon stump
gradually to facilitate insertion into and passage through the
pulley (or other narrow anatomical passage as the case may be). The
funnel 1101 of this embodiment also serves to dilate the entrance
to the pulley to even further facilitate passage.
[0141] Unlike the embodiment utilizing the flanged catheter 103, in
this embodiment, the funnel 1101 does not pass through the pulleys.
It remains in the position shown in FIG. 11C just inside the
entrance to the pulley, while the tendon stump 1116 slides through
the funnel 1101 and through the pulley 1121. Once the end of the
tendon stump 1116 has passed through the pulley 1121, the funnel
1101 is removed. Particularly, it can be spread apart and slipped
off the tendon. Alternately, the funnel can be cut away. FIG. 11D
shows the repair at this point of the procedure.
[0142] If the tendon stump 1116 must be guided through a second or
subsequent pulley, the same process is essentially repeated with
respect to the second pulley. For instance, if the tendon must pass
through a second pulley, then another incision can be made above
that pulley (in the corresponding crease of the finger) and the
aforescribed process can be repeated using the same or a different
funnel. However, the surgeon should first attempt to pull the
tendon through without using the funnel, as, often, the tendon
might track through a second or subsequent pulley without the help
of the funnel.
[0143] The tendon stump can then be (1) attached to the distal
tendon stump directly, (2) attached to another tendon repair device
attached to the distal tendon stump, or (3) be attached to a bone
anchor, as the case may be, using any one of the aforedescribed
tendon repair devices and/or techniques.
[0144] FIG. 11E illustrates an alternate embodiment of the guidance
member. The guidance member 1140 in this embodiment is of a split
hollow frustoconical form having a smaller diameter end 1143 and a
larger diameter end 1144, with a portion of the frustoconical
surface removed. The lateral opening 1142 defined by the removed
portion of the surface should be sufficiently wide to permit easy
insertion of the particular tendon, ligament, or other anatomical
feature with which it is intended for use, but sufficiently narrow
so as not to permit the tendon to slip out of the member 1140
accidentally. Thus, preferably, the opening is no more than 50% of
the conical surface. The opening, for instance, may be about 5%-35%
of the conical surface with 1/3 being preferred. In this
embodiment, since the guidance member 1140 need not deform to
permit the tendon to be inserted therein, it preferably is
substantially rigid and not deformable under normal loads. It may
be formed of a biocompatible metal, such as stainless steel or
titanium. Again, a handle 1198 may be provided to facilitate
handling of the guidance member 1140 by the surgeon.
[0145] The guidance member 1140 of this embodiment is used
essentially exactly as was described above in connection with the
funnel 1101 of the preceding embodiment, except that the member
1140 is not be spread apart in order to insert the tendon therein.
Rather, the tendon can simply be laid inside the member 1201
through the lateral opening 1142. As in the previous embodiment, a
handle 1198 may be provided to facilitate manipulation by the
surgeon.
[0146] This embodiment is advantageous in that it is easier to
insert a tendon in the member. Furthermore, the guidance member is
rigid and, therefore, provides more efficient dilation of the
anatomy.
[0147] FIG. 11F illustrates yet another alternate embodiment of the
guidance member. Like the embodiment of FIG. 11A, the guidance
member 1150 in this embodiment is a funnel 1151 with a small
opening 1152 and a large opening 1153. It is split along its entire
length, whereby it can be radially spread apart at the split 1154
to resiliently deform the funnel to provide a lateral gap at the
split 1154 through which a tendon, ligament or the like can be
inserted into the funnel.
[0148] A lip 1156 is provided at the large end to prevent the
funnel from being inadvertently pulled through a pulley. A small
handle 1157 provides a place for the surgeon to grasp the guidance
member 1150. The use of a small handle or merely a lip with no
handle at all per se facilitates the ease with which a surgeon may
spin the guidance member about its longitudinal axis. Specifically,
spinning is sometimes helpful in introducing the small end 1152 of
the guidance member into the pulley. A longer handle might
interfere with the ability to freely spin the guidance member
because a longer handle is more likely to hit an obstruction, such
as another part of the patient's hand or another surgical
instrument.
[0149] In still other embodiments, the guidance member could be
formed as a split cone with overlap at the split so as to have a
spiral-like shape. The overlap should be relatively small, such as
on the order of between about 5.degree. and 90.degree. of radial
overlap, and preferably about 70.degree. of radial overlap when
unstrained. Particularly, too much radial overlap might make it
difficult to spread the guidance member apart sufficiently to open
the gap through which the tendon must pass.
[0150] Embodiments with overlapping at the split have several
advantages. First, the overlap would make it essentially impossible
for the tendon to accidentally slip out of the gap in the guidance
member once the expansion pressure to open the gap is removed.
Second, the overlap will permit some adjustability to the radial
size of the guidance member. That is, by applying inward radial
force on the outer wall of the guide member, the radius of the
guide member can be decreased temporarily to help fit the small
opening of the guidance member into a pulley should that be
necessary. Conversely, the radius of the guidance member may be
temporarily increased should that be necessary to allow a tendon to
pass through the opening at the small end of the guidance member,
but without opening the gap in the side wall, which might allow the
tendon stump to inadvertently escape from the guidance member
through the gap). More specifically, if the tendon stump being
guided through the pulley system by the guidance member is smaller
than the opening at the small end of the guidance member, the
pulling force on the tendon repair device and tendon stump will
simultaneously also apply a radially outward force on the inner
wall of the guidance member. That outward radial force will force
the guidance member to radially expand, which will cause the
opening at the smaller end to increase in diameter and allow the
tendon stump to pass through.
Tenth Set of Exemplary Embodiments
[0151] While the invention has been described above in connection
with attaching two tendon stumps and/or one tendon stump directly
to bone, it should be understood by those of skill in the related
arts that it can also be employed in connection with repairs that
use a tendon graft. In such situations, one end of the tendon graft
is attached to one tendon stump and the other end of the tendon
graft is attached to either another tendon stump or directly to
bone using the above-described apparatus and techniques. The tendon
graft may be taken from another part of the patient's body, such as
the patient's foot, or may be an allograft.
[0152] In accordance with another aspect of the invention, a thin
walled tube that functions as an adhesion barrier may be placed
over the tendon at the repair site in order to facilitate the free
gliding of the tendon through the pulley system of the finger. More
particularly, as an injured tendon, ligament, or other longitudinal
anatomical member heals, scar tissue forms around the repair site.
During the healing process, the scar tissue can interfere with the
free movement of the tendon through the pulley system. Additional
surgery may also be needed to remove such scar tissue.
[0153] In order to facilitate the free movement of the tendon
through the pulley system, the repair site(s) may be encased in an
adhesion barrier in the form of a thin walled tube. The adhesion
barrier may comprise a thin walled tube 1201 such as illustrated in
FIG. 12A. FIG. 12B illustrates one particular embodiment of the
adhesion barrier being used in connection with a tendon repair in
which two tendon stumps are being reattached without an intervening
graft. As shown, the tube 1201 may be slipped over the end of one
of the severed tendon stumps 1203a prior to the repair being
performed and slid out of the way during the repair process. Then,
referring to FIG. 12C, after the repair is completed, the tube 1201
may be slid along the repaired tendon to the repair site 1204
(including the stitches, the tendon repair device, and both tendon
stumps 1203a, 1203b). Preferably, the tube 1201 is stitched to the
tendon at this point with at least one stitch 1221 and, preferably,
with each at least one stitch 1221 at each end of the tube.
[0154] The tube will provide a barrier to allow healing to take
place along the length of the tendon (inside the tube) rather than
outwardly where such scar tissue might interfere with the free
movement of the tendon through the pulley system. The tube may also
provide guidance for growth on the outside of the tube diameter to
bolster the structure that will ultimately provide the passageway
for the repaired tissue inside the tube. The external and internal
surfaces of the tube should be lubricious and have a low friction
coefficient so that it (with the tendon inside of it) can slide
freely through the pulley system and allow the tube to be removed
after healing has occurred.
[0155] The wall thickness of the tube should be as thin as possible
so as to add minimal bulk to the tissues being repaired. In the
case of flexor tendon repair, wall thicknesses of less than 0.25 mm
are contemplated. However, the best wall thickness of the tube
depends upon the surgical application of the repair and should
proportionally thin compared to the tissue being repaired. The
length and diameter of the tube will, of course, be dictated
primarily by the particular repair. Furthermore, the tube should be
formed of a bio-inert material, such as a material chosen from the
family of fluoropolymers of Teflon.TM., PET, PTFE, and EPTFE or the
family of silicone polymers. Preferably, the tube is porous so as
to allow fluid exchange therethrough in order to keep the tendon
healthy. It may have holes or other openings to facilitate such
fluid transfer. Preferably, the holes are small enough so as not to
permit tissue ingrowth therethrough. It may also be coated with a
lubricant to facilitate sliding through the pulley system (or any
other anatomical restrictions). Passive motion of the finger during
the healing period of the tendon will also prevent any scar tissue
adherence of the tendon to the surrounding tissues through the
holes in the tube.
[0156] The tube should be long enough to completely cover the
repair site. In the case of a repair utilizing a graft, depending
on the length of the graft, accessibility and other factors, a
single longer tube may be used to cover both ends of the graft or
two separate, smaller tubes may be used.
[0157] The tube will remain in place for the duration of the
healing process, from several weeks to several months. At the end
of the process, it may be removed by making one or more small
incisions in the patient near one end of the tube and then
carefully pulling the tube out of the incision as the surgeon cuts
the tube. In alternate embodiments, the tube may be formed of a
bioabsorbable material that will simply dissolve over time,
provided that the bioabsorbable material does not promote adhesions
or a local tissue response as it absorbs. An example of a
bioabsorbable material would be a crosslinked Hyaluronic Acid or
other bioinert polymer. In yet another embodiment, the adhesion
barrier may be provided with a longitudinal slit over its entire
length so that no cutting would be necessary when it is removed,
but rather, it would simply need to be spread apart to be removed
from the tendon. Such an embodiment would also facilitate the
option of installing the adhesion barrier over the repair site by
spreading it apart and slipping it over the tendon after the repair
is completed, thereby eliminating the need to slide it
longitudinally over the end of a tendon stump before the repair and
then sliding it over the repair site after the repair is completed.
This may be advantageous where the repair site is long and/or there
is insufficient available length of the tendon stump to slide the
adhesion barrier out of the way during the repair procedure.
Eleventh Set of Exemplary Embodiments
[0158] FIGS. 13A-13C, and 14A-14C illustrate further alternate
embodiments and associated techniques to be used therewith, which
techniques can be used in conjunction with some or all of the
features and aspects of many of the other embodiments of both the
methods and apparatus disclosed herein. FIG. 13A is a perspective
view of one embodiment of a unitary dilation catheter in accordance
with this set of embodiments. FIG. 13B is a perspective view of one
embodiment of a multi-piece dilation catheter in accordance with
this set of embodiments. The dilation catheter is designed to fit
through and dilate the passage or passages (e.g., pulleys) through
which the longitudinal anatomical member (e.g., tendon) must be
pulled. As will be described in detail below, it will essentially
be used like and serve the same functions as the pulley catheter
101 of the first set of embodiments described in connection with
FIGS. 1 and 2A-2L above. However it also will serve to dilate the
passage. FIG. 13C is a perspective view of a guide member that may
be used in conjunction with the dilation catheter to dilate the
passage. Particularly, as will be described in detail below, it may
serve essentially as a guidewire for inserting the dilation
catheter through the pulley system. However, it is believed that
the guide member will be unnecessary in the majority of
applications.
[0159] The dilation catheter 1301 comprises an elongated tube
having a lumen therein. The tube comprises a series of consecutive
stepped diameter longitudinal segments 1302, 1303, 1304, 1305, each
consecutive segment larger than the previous. The use of four steps
in the illustrated embodiment is merely exemplary. Any number of
steps is possible. The outer diameters and number of different
diameter segments should be determined as a function of the size of
the anatomical passage or opening through which the dilation
catheter 1301 will pass. We will continue to use the example of a
severed tendon in the hand in the following discussion. The
smallest diameter segment should be smaller than the diameter of
the pulley system of the smallest hand size reasonable through
which it must pass so that the smallest diameter segment can pass
through any pulley system relatively easily. Each larger diameter
segment should be designed to gently and in a gradual, stepped
manner dilate the pulley system to a larger size in preparation for
passing the tendon stump therethrough. The last, largest diameter
segment of the dilation catheter should be at least as large as the
largest diameter to which one would reasonably dilate the pulley
system of the largest reasonable hand size.
[0160] As will be seen from the discussion below, according to one
exemplary technique, any segment having a diameter that is larger
than needs to be passed through the pulley system of the particular
patient simply will not be passed through the pulley. Therefore,
the largest diameter segment of the dilation catheter can be
virtually any diameter. In one embodiment adapted for use in
passing tendons through the pulleys of the fingers, the various
segments of the dilation catheter range from a smallest diameter of
about 10 French to a largest diameter of about 18 French. In one
embodiment, this is accomplished with nine segments of 10 F, 11 F,
12 F, 13 F, 14 F, 15 F, 16 F, 17 F, and 18 F diameters. Each
segment may be about 10 cm in length.
[0161] In one embodiment such as illustrated in FIG. 13A, the
dilation catheter 1301 can be unitary. If, prior to or during the
surgical procedure, the surgeon determines that any of the smaller
diameter segments are clearly smaller than will be needed and/or
any of the larger diameter segments are larger than will be needed,
the surgeon may simply cut them off prior to use or during the
procedure. Hence a single dilation catheter can be offered that can
be used in a large number of different anatomical passages and with
a large number of different sized patients, thus reducing the
number of different versions of the dilation catheter that need to
be manufactured.
[0162] In another embodiment of the dilation catheter 1310 such as
illustrated in FIG. 13B, each diameter segment 1311, 1312, 1314, et
seq. may be separable from each other. For instance, in one simple
embodiment, each catheter segment may have a neck portion 1315 near
its proximal longitudinal end sized to mate in an interference fit
with the distal end of the next smaller diameter segment.
Preferably, the necked down portion is sized to fit within the
distal end of the next smaller segment so that the edges of the
longitudinal ends of the various segments will not be exposed on
the outside of the dilation catheter 1310.
[0163] Like the pulley catheter 101, the dilation catheter
preferably is formed of a biocompatible, low friction material
having a wall thickness sufficient to make the entire catheter
sufficiently stiff to be pushed through the pulley system and to
serve the purpose of dilating (holding open) the pulleys against
their natural size, yet soft and resilient enough to track through
curves in the anatomical passage through which it must pass. It
might, for instance, have the approximate flexibility of a typical
surgical vascular catheter. The inner diameter of all of the
segments should be large enough to easily accommodate the tendon
repair device that will be used with the dilation catheter.
[0164] In yet other embodiments, the dilation catheter need not
have discrete segments of different diameter, but may be
continuously tapered over its entire length. As in the segmented
embodiments, any portion or portions of the catheter clearly not
necessary for the surgery may be cut off before insertion and any
portion not necessary after insertion may be curt off after the
dilation catheter is in place in the anatomical passage.
[0165] FIG. 13C illustrates an optional guide member 1320. As
shown, the guide member comprises an elongate member having an
outer diameter smaller that the inner diameter of lumen in the
smallest diameter segment of the dilation catheter so that the
dilation catheter may pass over the guide member easily. In other
words, the entirety of the lumen of the dilation catheter is of
sufficient size and shape to accept the guide member 1320
therethrough. The guide member 1320 may be cannulated. Alternately,
it may be solid (e.g., essentially a guidewire). The guide member
should be relatively stiff so that it can be pushed through the
pulley system without kinking, yet sufficiently flexible to track
through curves in the anatomical passages through which it will be
passed in accordance with the techniques disclosed herein. The
outer diameter of the guide member should be substantially smaller
than the anatomical passage through which it must pass.
[0166] In most practical embodiments, the guide member and dilation
catheter will both be cylindrical. However, a cylindrical
cross-section is not necessary, and, depending on the particular
anatomical passage through which the guide member and dilation
catheter will be passed, other shaped cross-sections may be
preferable. The term diameter is used in this application in a
non-limiting manner and not to imply that the cross-section
necessarily is cylindrical.
[0167] Preferably, each of the segments of different diameter of
the dilation catheter is long enough to individually traverse the
entire length of the anatomical passage through which it will be
passed and stick out sufficiently at each end thereof to provide
easy access thereto to the surgeon. Particularly, as will be
discussed in detail further below, after the dilation catheter is
placed through the relevant anatomical passage, all segments other
than the largest segment that fit through the passage can be cut
off or removed. For a human hand, 10 cm should be sufficient.
[0168] The dilation catheter (and optional guide member) is used to
dilate the pulley system so as to best assure that the tendon stump
will be able to pass through the pulley system without binding.
Both the guide member and the dilation catheter are hollow tubes
formed of a biocompatible polymer of such composition and/or wall
thickness so that it is bendable, but sufficiently rigid to be
pushed through a pulley system. The relative rigidity of the
dilation catheter and guide member will permit it to be pushed
through narrow anatomical passages, such as the pulleys of the
fingers. However, its flexibility will permit some bending to
accommodate an overall curved path. Preferably, the dilation
catheter is formed of a material having a low friction coefficient
to allow the dilation catheter to readily pass through and around
bodily tissues such as the tendon pulley system.
[0169] Suitable biocompatible polymers include homopolymers,
copolymers and blends of silicone, polyurethane, polyethylene,
polypropylene, polyamide, polyaryl, flouropolymer, or any other
biocompatible polymer system that meets the mechanical
characteristics above (PELLETHANE.TM. a DOW thermoplastic
polyurethane elastomers (TPU), which is commonly use in other
dilating catheters is targeted for this device.)
[0170] The required low coefficient of friction of the surfaces of
the dilation catheter may be inherent to the materials used to
construct the device or may be enhanced through a surface
preparation such as a lubricious coating or mechanical modification
of the surface such as longitudinal recesses.
[0171] The particular length, material, wall thickness, inner
diameter, outer diameter, and stiffness of the dilation catheter
will vary depending on the particular tendon or ligament with which
is it to be used.
[0172] The inner diameter should be large enough to easily
accommodate the cable portion and straight needle of the tendon
repair device. The particular material and cross sectional geometry
(e.g., wall thickness) of the dilation catheter will largely
dictate the stiffness of the catheter and, as noted above, should
be selected to provide enough rigidity to allow it to be pushed
through a narrow path, but flexible enough to bend to accommodate
bends in the path. In the exemplary case of the flexor digitorum
profundus at the level of the middle phalanx, the pulley catheter
may be formed of silicone and be 120 millimeters in length with a
wall thickness of 0.5 mm, and an outer diameter of 2 mm. A
biocompatible elastomer having a durometer of 50-90 (Shore A) may
be used for the dilation catheter.
[0173] Similarly to the pulley catheter 101 of FIG. 1, the dilation
catheter, with or without the guide member, can be used in
connection with a tendon or other repair using virtually any of the
tendon repair devices and related accoutrement described herein and
in conjunction with virtually any of the surgical techniques
described herein.
[0174] FIGS. 14A-14G illustrate various stages in an exemplary
surgical procedure to reattach a severed tendon. If the tendon
stump has retracted and must be retrieved from a first incision
into a second incision (or the wound), as is typical of tendon
lacerations in the hand, first, an incision 1361 is made, typically
in the palm of the hand, as illustrated, where the proximal tendon
stump 1370 can be retrieved. If, on the other hand, the proximal
tendon stump is distal to the A2 pulley, then the tendon would be
exposed through an incision just distal to the A2 pulley. Referring
first to FIG. 14A, if a guide member is used, the guide member 1320
is passed into the wound or incision 1360 at the laceration site
and slowly pushed proximally toward the other incision 1361 beneath
the A3 pulley through the pulley system of the finger. If
resistance is encountered such that the pulley catheter cannot be
pushed through proximally, then a 1/2 cm to 1 cm incision (not
shown) may be made midway between the skin creases of the proximal
interphalangeal joint of the finger and the crease at the base of
the finger. This is at a level between the A2 pulley and the A3
pulley of the finger. The dissection is carried down gently to the
flexor sheath where the pulley will be found. The dilation catheter
1301 can then be pulled past the obstruction or resistance through
this incision. The guide member 1320, if used, should be long
enough to pass entirely through the pulley system and stick out at
both ends. If the guide member is substantially longer than the
desired length, it may be cut to a suitable length either before it
is inserted or after.
[0175] With reference to FIG. 14B, once the guide member 1320 is in
place, the dilation catheter 1301 (or 1310) is slipped through the
pulley system over the guide member 1320 working from distal to
proximal. Particularly, the smallest diameter portion 1302 is
slipped over the guide member 1320 and pushed over the guide member
through the pulley system until it exits the other incision. In
embodiments omitting the guide member 1320, the smallest diameter
segment of the dilation catheter 1301 is simply inserted through
the pulley system just as described above for the guide member.
[0176] In either event, the smallest diameter segment of the
dilation catheter is slid back-and-forth about 10 mm to enlarge the
annular rings. Then the next larger catheter segment is pulled
through and slid similarly. This continues for each longitudinal
segment of the dilation catheter until the surgeon determines that
the annular rings in the pulley system are enlarged enough to
accept passage of the tendon stump. Generally, this will be at
about the 14, 16, or 18 French diameters for most hands. This
largest fitting catheter size is centered between the two surgical
wounds 1360, 1361. In this example, segment 1304 is the largest
segment passed through the pulley system.
[0177] With reference to FIG. 14C, once the dilation catheter 1301
is in place, the guide member, if used, 1320 may be removed.
[0178] With reference to FIG. 14D, at this point, all of the
segments of the dilation catheter other than the one traversing the
pulley system can be removed. As previously mentioned, if the
dilation catheter is unitary, then the other diameter segments of
the dilation catheter can be cut off. On the other hand, if the
dilation catheter comprises multiple separable segments, then the
other segments can simply be pulled off. In addition, the surgeon
also may cut off part of the remaining segment if it is longer than
needed.
[0179] At this point, the surgical procedure to reattach the tendon
stump can be performed essentially as described in accordance with
any of the embodiments discussed previously in this specification,
with the tendon repair device and tendon stumps being passed
through the dilation catheter rather than the pulley catheter.
[0180] Thus, for example, with reference to FIG. 14E, a flexible
barrier 1376 is placed under the tendon holder to create a working
`table` for suture repair and a tendon holder may be used to pierce
the tendon stump to hold the tendon stump for stitching. Next, a
tendon repair device, which could be any of the tendon repair
devices previously discussed herein, is attached to the end of the
tendon stump 1370. FIGS. 14A-14G, illustrate an embodiment in which
a single suture 1401 with a needle 1402, 1403 at each end thereof
is used to perform the repair. In this embodiment, one needle may
be curved and the other straight or both needles may be straight.
In fact, a repair could be performed with a needle on only one end
of the suture; however, having a needle at each end is advantageous
and will allow the stitching to be performed much faster since the
surgeon can stitch from both ends of the suture. In any event, the
suture is stitched to the proximal tendon stump using the
needle(s). A modified cruciate stitching technique, as will be
discussed in more detail below in connection with FIG. 15, provides
a particularly advantageous stitch because it is a locking
stitch.
[0181] Once the tendon repair device 1350 is securely fixed to the
proximal tendon stump 1370, the tendon stump is removed from the
tendon holder, if used. Next, the loose end(s) 1350a, 1350b of the
suture 1350 are passed all the way through and out of the other end
of the dilation catheter 1301 (essentially as previously described
in connection with the pulley catheter 101). Stainless steel
sutures typically have sufficient rigidity to permit them to be
pushed through the dilation catheter segment. In fact,
multifilament stainless steel sutures such as described above in
connection with previous embodiments of the suture repair device
are particularly suitable because they are strong, exhibit little,
if any, shape memory, and hold knots quite well. One exemplary
suture is the multifilament stainless steel 4-0 (MFSS) suture
available from Fort Wayne Metals of Fort Wayne, Ind., USA. The MFSS
comprises 49 wound filaments of 0.023'' diameter 316L stainless
steel wire. There are seven sets of seven wires wound with each
other, each set comprising seven wires wound with each other.
[0182] Whichever type of suture is used, it may be desirable to
lodge at least the tips of the needles on the ends of the suture in
a small diameter rod that is smaller than the inner diameter of the
dilation catheter before passing them through the dilation catheter
1301. This will help prevent the needles from sticking into the
side of the lumen of the dilation catheter 1301 and getting stuck.
In one embodiment, the rod may be a small, double lumen tube, and
each needle 1351, 1352 may be inserted into one of the lumens. The
lumens may be sized so that the needles 1351, 1352 fit within the
respective lumens in a friction fit. Alternately, the rod may be
solid (i.e., not a hollow tube with a lumen) and made of a material
soft enough to be punctured by the needles so that the needles
could be pushed into the end of the rod, like a pin cushion. FIG.
14E illustrates yet another embodiment, in which a tube 1368 has a
single lumen sized to accept both needles 1351, 1352 together in a
friction fit. The tube 1368 need be only long enough to accept the
tips of the needles and provide a sufficient length over the
needles to form a reasonable friction fit so that the tube does not
fall of the needles.
[0183] In other embodiments, if one of the needles is a curved
needle, the needle can be cut off after stitching and the bare
suture end can be inserted into the tube 1368 along with the needle
at the other end of the suture. In yet even further embodiments,
only one end of the suture may be passed through the dilation
catheter 1301. Thus, the other end of the suture may have a curved
needle that is simply cut off after stitching or no needle at
all.
[0184] In any event, FIG. 14F illustrates yet another possible
embodiment. In this embodiment, the tube 1368 of FIG. 14E is
replaced with a much longer tube or rod 1380. Tube or rod 1380 is
long enough to be passed through the dilation catheter in the
distal to proximal direction and extend from both ends of the
dilation catheter. After the suture 1350 (or other tendon repair
device) has been stitched to the tendon stub 1370, the needle(s)
1351, 1352 can be inserted into the proximally facing end 1380a of
the tube 1380 and the surgeon can grasp the distally facing end
1380b of the tube or rod that is protruding from the distal end of
the dilation catheter 1301 and pull the suture(s)/tendon repair
device 1350 through the dilation catheter, rather than pushing it
through. This embodiment is advantageous in that it allows other
types of suture(s), such as nylon sutures, that may not have
sufficient stiffness to be pushed through the dilation catheter, to
be used in the repair. Alternately, a short tube, rod, block or
anything to which the needles can be temporarily affixed (e.g., by
sticking, adhesive, tape etc.) may be attached to the end of any
longitudinal member (e.g., another suture, a narrow surgical
instrument) that is thin enough to fit within the dilation catheter
in order to pull the sutures through the dilation catheter.
[0185] In any event, after the tendon repair device/suture 1350 is
through the dilation catheter and extending from its distal end
1301a, if the stitched end of the tendon stump 1370 is sufficiently
small to pass into the dilation catheter itself, it can be pulled
just into the proximal end 1301b of the dilation catheter 1301 and
then the dilation catheter 1301, tendon repair device/suture(s)
1350, and tendon stump 1370 can be pulled through the pulley system
as a unit as previously described in connection with the pulley
catheter 101 of FIG. 1.
[0186] However, with reference now to FIG. 14G, most likely the
tendon stump 1370, because of its deformation and excess bulk due
to the stitching, will not readily fit within the dilation catheter
1301. In such cases, the leading end of the tendon repair device
1350 is pushed or pulled through the dilation catheter 1301 to a
point where the end of the tendon stump 1370 is close to, but not
touching the trailing end 1301b of the dilation catheter 1301, as
seen in FIG. 14G.
[0187] Next, the dilation catheter 1301, tendon repair device 1350,
and tendon stump 1370 are pulled as a unit through the pulley
system to a point where the trailing end 1301b of the dilation
catheter 1301 has passes the entrance of the first pulley 1321 that
must be traversed with the end tendon stump 1370 is near the
entrance to the pulley 1321, as shown in FIG. 14G. This may require
the making of an additional incision 1333 adjacent an end of the
pulley if the existing incisions are not already adjacent the
pulley entrance. In fact, as will become clear, such an additional
incision may be necessary for each separate pulley that must be
traversed. A funnel, such as 1140 of FIG. 11E, is slipped over the
tendon stump 1370 with the small end 1143 of the funnel positioned
slightly inside of the entrance to the pulley 1121 and the large
end 1144 facing away from the entrance to the pulley.
[0188] With the funnel 1140 in the position shown in FIG. 14G, the
surgeon can then pull on the leading end of the tendon repair
device 1350 and dilation catheter 1301 to draw the end of the
tendon stump 1370 into and through the funnel 1140 and the pulley
1321.
[0189] The funnel 1140 contains the end of the tendon stump 1370
gradually to facilitate insertion into and passage through the
pulley 1321. The tendon stump 1370 slides through the funnel 1140
and through the pulley 1321. Once the end of the tendon stump 1370
has passed through the pulley 1321, the funnel 1140 is removed, as
seen in FIG. 14G.
[0190] The dilation catheter 1301 may be provided with mm markers
on its surface to assist in determining exactly where a hidden
blockage is positioned (and a new incision must be made) when
pulling the tendon through the pulley system with the dilation
catheter. Particularly, the specific mm mark at the skin in the
incision is noted prior to pulling the tendon through the finger.
If a resistance is encountered, then the mm marking at the same
location of the skin is noted. The exact site of the blockage is
calculated by determining the difference between the two observed
markings and measuring the equivalent distance on the skin surface
of the patient.
[0191] If the tendon stump 1370 must be guided through a second or
subsequent pulley, the same process using the funnel 1140 is
repeated with respect to the second or subsequent pulley.
[0192] If there is a distal tendon stump that has retracted and
must be passed through a different portion of the pulley system in
the opposite direction, then that can be done using the techniques
and apparatus just described, but working in the opposite
direction.
[0193] The tendon stump 1370 can then be (1) attached to the other,
mating tendon stump directly, (2) attached to another tendon repair
device attached to the other, mating tendon stump, or (3) be
attached to a bone anchor, as the case may be, using any one of the
aforedescribed techniques. Particularly, the two tendon stumps are
brought together in an abutting condition and the needle(s) and
suture(s) extending from the proximal tendon stump are stitched to
the distal tendon stump. A tendon holder may be used to help bring
or hold the tendon stumps together by adjusting the positions of
the needles of the tendon holder toward the center so that they are
very close to each other and piercing each tendon stump with one of
the needle pairs. The needle(s) and suture(s), if any, previously
attached to and extending from the distal tendon stump can also be
stitched to the proximal tendon stump to double the strength of the
repair. Again, a modified cruciate stitch may be used.
[0194] FIG. 15 illustrates the aforementioned modified cruciate
repair stitch as used in the exemplary repair procedure of FIGS.
14A-14G. The numbers 1-14 in FIG. 15 provided alongside some of the
linear segments of the sutures and near the knots help indicate the
chronological order of the stitching steps. The dashed lines
indicate that the suture is within the substance of the tendon and
the solid lines indicate that the suture is on the surface of the
tendon.
[0195] Chronologically, (1) the first suture 1350 is stitched to
the proximal tendon stump 1370 using a modified cruciate stitch as
shown (steps 1-3), (2) a second suture 1380 is stitched to the
distal tendon stump 1390 also using a modified cruciate stitch as
shown (steps 4-6), (3) after the two tendon stumps are brought
together (a tendon holder may be used to help bring or hold the
tendon stumps together by adjusting the positions of the needles of
the tendon holder toward the center so that they are very close to
each other and piercing each tendon stump with one of the needles
or needle sets), the first suture is then stitched to the distal
tendon stump using another modified cruciate stitch (steps 7-9),
(4) the two ends of the first suture are tied together with a knot
(steps 10), (5) the second suture is stitched to the proximal
tendon stump with another modified cruciate stitch (steps 11-13),
and (6) the two ends of the second suture are tied together with a
knot (steps 14). Finally, although not shown in FIG. 15 in order
not to obfuscate the illustration of the modified cruciate
stitches, one or more epitendonous stitches (using 6-0
Ethibond.TM.) may be applied circumferentially at the repair
junction.
[0196] FIG. 16 is a perspective view of another embodiment of a
tendon holder. In this embodiment, the tendon holder 807 still
comprises a handle 801, and a cross bar 803 at the distal end of
the handle 801. In this embodiment, the cross bar holds a
turnbuckle 812 (essentially a screw with oppositely directed
threads on each half 812a, 812b of its length) between two
rotatable mounting points 813, 814 on arms 816a, 816b. A knob is
attached to at least one end of the turnbuckle to permit the
surgeon to rotate the turnbuckle. A needle holder block 815 is
threadedly mounted on each half 812a, 812b. Thus, when the
turnbuckle 812 is rotated in one direction, the two needle holder
blocks 815 approximate each other (i.e., they move medially toward
each other on the turnbuckle 812. When the turnbuckle 812 is
rotated in the other direction, the two needle holder blocks 815
move laterally away from each other on the cross bar 803. An
unthreaded larger diameter cylindrical portion 821 of the
turnbuckle 812 exactly in the middle of the turnbuckle may be
provided to prevent the two needle holder blocks 815 from hitting
each other. A support block 822 may hold the unthreaded cylindrical
portion 821 rotatably therein to provide support for the turnbuckle
812 intermediate its two ends.
[0197] Each needle block can hold a number of different needles in
different configurations. Particularly, each needle block 815
includes a transverse threaded hole 825 for accepting a needle
holder 823. The needle holder 823 comprises a screw shank 826 with
mating threads to the transverse threaded holes and a head 827 at
its proximal end for manually rotating the screw 826 into the
transverse hole 825 of the needle block 815. One or more needles
828 extend from the distal end of the screw 826 for holding
tendons. Different needle holders with different numbers and
configurations of needles can be provided for addressing different
surgical conditions.
[0198] Each needle block 815 further comprises one or more
additional holes 818 through which needles or K-wires may be
inserted. The various holes 818 may be oriented at different angles
in order to provide a plurality of choices as to the angle(s) at
which the needle(s) or K-wire(s) extend from the block.
Particularly, when the apparatus and techniques of the present
invention are used to reattach a tendon or ligament that has
avulsed from the bone, rather than been lacerated, one of the
blocks can be used to attach the tendon holder to the bone, rather
than one of the tendon stumps. Then, the tendon holder can be to
approximate the tendon stump to the bone. For instance, one or more
a K-wire may be passed through one or more of holes 818 of one of
the blocks 816 and stuck into the bone to which the avulsed tendon
stump is to be reattached (such as by any of the techniques
described above in connection with FIGS. 4A-4D). The needle(s) of
the other block 816 are stuck into the tendon stump and the
turnbuckle is turned to approximate the tendon stump to the
bone.
[0199] In use, the turnbuckle can be turned to position the needles
with a desired spacing relative to each other before piercing the
tendon stump(s) with the needles. Alternately, two tendon stumps
that are to be rejoined can be pierced with one of the needles (or
plurality of needles) and then the turnbuckle can be turned to draw
the needle blocks medially toward each other to bring the stumps
into abutting contact.
[0200] A stabilizer bar 831 may be provided for use with the tendon
holder, into which the tips of the needles 828 can be stuck both
before and during surgery. The stabilizer bar 831 may be a cylinder
formed of a relatively soft cylinder of material 832 that the
needles can penetrate relatively easily that is partially wrapped
in a second annulus of harder material 833 with a gap 834 through
which the soft inner material 832 is accessible for sticking the
needles into it. The harder outer material 833 is much more
difficult to penetrate with the needles, and thus will prevent the
needles from poking all the way through the stabilizer bar 831 and
becoming exposed again. Alternately, the stabilizer bar may be
formed unitarily of materials with two different hardnesses, such
as by a dual extrusion process.
[0201] Both before and during surgery, the stabilizer bar 831 can
serve several functions. First, it protects the needle tips,
preventing the surgical personnel from inadvertently sticking
themselves or anything else with the needles. Second, it braces the
needles, creating a rectangular structure that helps prevent the
needles from inadvertently being bent out of shape. Finally, during
surgery, it can prevent the tendon stumps from becoming
inadvertently disengaged from the needles.
CONCLUSION
[0202] Preliminary testing has shown failure strengths of tendon
reattachments performed in accordance with the principles of the
present invention of approximately 70-100 Newtons. Accordingly, a
tendon and ligament repair in accordance with the principles of the
present invention results in a much stronger result that the
current standard of care.
In addition, the procedure is greatly simplified as compared to the
present standard of care.
[0203] The present invention provides a safe, simple, easy, and
strong repair for tendons, ligaments, and the like. In preliminary
tests, failure strengths of up to 100 N have been observed.
[0204] It should be understood that the numbers of sutures/cables
and needles forming the various parts of the tendon repair devices
described in association with the various embodiments herein are
merely exemplary and that fewer or more sutures/cables (and
needles) may be provided depending on the desired strength of the
repair, the particular tissue that is being repaired, the strength
of the material from which the tendon repair device is
manufactured, and other factors.
[0205] Even though description of the utility of the various
embodiments was limited to the flexor tendons of the hand, it must
be understood that many soft tissue repairs can be carried out by
use of the device as described, either in part of in full. Examples
of such anatomical structures include the tendons and ligaments of
the body as well as any other structure require fixation in
multiple points, subsequently attached to soft tissue or to
bone.
[0206] Having thus described particular embodiments of the
invention, various alterations, modifications, and improvements
will readily occur to those skilled in the art. Such alterations,
modifications, and improvements as are made obvious by this
disclosure are intended to be part of this description though not
expressly stated herein, and are intended to be within the spirit
and scope of the invention. Accordingly, the foregoing description
is by way of example only, and not limiting. The invention is
limited only as defined in the following claims and equivalents
thereto.
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