U.S. patent application number 14/641024 was filed with the patent office on 2015-06-25 for method for tendon repair.
The applicant listed for this patent is Exsomed International IP, LLC. Invention is credited to Lloyd P. Champagne, Jozef Zoldos.
Application Number | 20150173737 14/641024 |
Document ID | / |
Family ID | 49325780 |
Filed Date | 2015-06-25 |
United States Patent
Application |
20150173737 |
Kind Code |
A1 |
Champagne; Lloyd P. ; et
al. |
June 25, 2015 |
METHOD FOR TENDON REPAIR
Abstract
Disclosed is a device and method for repairing a partially or
totally ruptured tendon. The device comprises an implant placed
inside or outside of the tendon on either side of the rupture in
order to strengthen the ruptured area during repair. Once
positioned inside the tendon, the tendon is held in place so it can
heal either by sewing or stapling through the tendon and implant,
or by any other suitable method that utilizes the implant to
provide strength to the ruptured area. In this manner the tendon
can heal with less chance of rupturing again prior to healing.
Inventors: |
Champagne; Lloyd P.;
(Phoenix, AZ) ; Zoldos; Jozef; (Phoenix,
AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Exsomed International IP, LLC |
Avarua |
|
CK |
|
|
Family ID: |
49325780 |
Appl. No.: |
14/641024 |
Filed: |
March 6, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13548060 |
Jul 12, 2012 |
|
|
|
14641024 |
|
|
|
|
61589526 |
Jan 23, 2012 |
|
|
|
Current U.S.
Class: |
606/228 |
Current CPC
Class: |
A61B 17/04 20130101;
A61F 2002/087 20130101; A61F 2/0811 20130101; A61B 17/122 20130101;
A61B 17/06166 20130101; A61B 2017/06176 20130101; A61F 2/08
20130101; A61B 2017/0648 20130101; A61B 2017/06057 20130101; A61F
2002/0817 20130101; A61B 17/1146 20130101; A61B 17/06066 20130101;
A61B 17/0643 20130101; A61B 2017/0641 20130101; A61B 17/128
20130101; A61F 2002/0858 20130101; A61B 17/06 20130101; A61F
2250/0067 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A method of repairing a ruptured tendon by using a tendon repair
device that includes a body with an outer surface including
stiplets, the tendon having a first end on one side of the rupture
and a second end on the other side of the rupture, the method
comprising the steps of: positioning a first end of the tendon
repair device into the first end of the tendon; positioning a
second end of the tendon repair device into the second end of the
tendon; pressing together the first end of the tendon and the
second end of the tendon over the tendon repair device.
2. The method of claim 1 wherein the first end of the tendon is
physically attached to the second end of the tendon by
suturing.
3. The method of claim 1 wherein the first end of the tendon is
physically attached to the second end of the tendon by one or more
of staples, rivets, snaps and clamps.
4. A method of repairing a ruptured tendon by using a tendon repair
device comprising a hollow tube having an inner surface including
raised portions comprising one or more of ribs, backward angled
ribs, barbs and stiplets, the tendon having a first end on one side
of the rupture and a second end on the other side of the rupture,
the method comprising the steps of: positioning the first end of
the tendon into a first end of the tendon repair device;
positioning the second end of the tendon into a second end of the
tendon repair device; pressing together the first end of the tendon
to the second end of the tendon inside of the tendon repair
device.
5. The method of claim 4 wherein the first end of the tendon is
physically attached to the second end of the tendon by
suturing.
6. The method of claim 4 wherein the first end of the tendon is
physically attached to the second end of the tendon by one or more
of staples, rivets, snaps and clamps.
7. The method of claim 4 wherein the first end of the tendon is
held in place against the second end of the tendon by clamping the
first end of the tendon and the second end of the tendon.
8. The method of claim 5 wherein the tendon is first secured into
position by pins or spikes.
9. The method of claim 6 wherein the tendon is first secured into
position by pins or spikes.
10. The method of claim 1 wherein the outer surface of the tendon
repair device further includes: one of a spiraled configuration, a
cruciate cross section, and a plurality of outwardly-extending
ribs.
11. The method of claim 4 wherein the inner surface of the tendon
repair device further includes one of a spiraled configuration and
a cruciate cross section.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application in a divisional application of U.S. patent
application Ser. No. 13/548,060 entitled "DEVICES AND METHODS FOR
TENDON REPAIR," filed on Jul. 12, 2012, which claims priority to
U.S. Provisional Patent Application Ser. No. 61/589,526 entitled
"TENDON REPAIR DEVICE AND METHOD," filed on Jan. 23, 2012, the
disclosures of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a device and method for
repairing a ruptured tendon that reduces the likelihood of the
tendon being partially or completely ruptured again while
healing.
BACKGROUND OF THE INVENTION
[0003] When a tendon is partially or totally ruptured or severed
(collectively, "a rupture"), the two ends of the tendon where the
rupture occurred are reattached surgically. In practice, this is
accomplished by a surgeon stitching (i.e., suturing) the two ends
together. The suturing can be done in any suitable manner, as there
have been many demonstrated techniques of suture repair. A problem
with these standard suture techniques is that the sutured tendon is
relatively weak until the tendon is fully healed and the tendon can
rupture if the force applied to the repaired tendon exceeds the
strength of the repair.
SUMMARY OF THE INVENTION
[0004] The invention comprises an implant placed inside or outside
a ruptured tendon on both sides of the rupture in order to
strengthen the tendon repair of the ruptured area during healing.
Once positioned inside or outside the tendon the implant and tendon
are secured together by sewing or stapling through the tendon and
implant, or by any other suitable method (including staples, tacks
or rivets) that utilizes the implant to provide strength to the
ruptured area. In this manner the tendon can heal with less chance
of rupturing again prior to healing.
[0005] Instead of an internal implant, each end of the ruptured
tendon may be positioned inside a tube (or other type of external
implant) and retained there in order for the tendon to heal. Again,
the material forming the external implant adds strength to the
ruptured area to help prevent the tendon from rupturing again prior
to healing. The tendon and external implant can be secured together
by any physical means, such as those as noted above.
[0006] Methods of using tendon repair devices according to the
invention are also disclosed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 shows an embodiment of a device according to the
invention.
[0008] FIGS. 2A-2C show an embodiment of a needle according to the
invention.
[0009] FIG. 3A-3D show various implants having surface textures and
material configurations according to aspects of the invention.
[0010] FIG. 4 depicts the first step in positioning a device
according to the invention in a ruptured tendon.
[0011] FIG. 5 depicts a second step in positioning a device
according to the invention in a ruptured tendon.
[0012] FIGS. 6A-6C depicts a third step in positioning a device
according to the invention in a ruptured tendon.
[0013] FIG. 7 depicts a fourth step in positioning a device
according to the invention in a ruptured tendon.
[0014] FIG. 8 depicts a needle according to the invention.
[0015] FIG. 9 shows an embodiment wherein needles or spikes are
used to temporarily or permanently secure the ruptured area of a
tendon in place.
[0016] FIG. 10 shows rivets that could be used to secure an insert
in place in a tendon for repair.
[0017] FIG. 11 shows rivets of the type shown in FIG. 10 that could
be used to secure an insert inside of or outside of a tendon.
[0018] FIG. 12 shows another type of fastener that may be used to
secure an insert inside of or outside of a tendon.
[0019] FIG. 13 shows a tendon that is first secured over spikes or
needles and a knife that goes through the tendon to pull an insert
through the tendon and the rupture.
[0020] FIG. 14 shows an insert according to an aspect of the
invention that includes directional barbs that help prevent the
insert from being dislodged from the tendon.
[0021] FIG. 15 shows an alternative shaped insert that may be used
inside of a tendon.
[0022] FIG. 16 shows an insert that is positioned outside of the
tendon.
[0023] FIG. 17 shows two cross-sectional views of inserts that may
be positioned outside of a tendon.
[0024] FIG. 17A is a view of an embodiment of the insert of FIG. 16
laid out flat to show its interior surface.
[0025] FIGS. 18-20 show different embodiments of an insert that may
be used inside of a tendon.
[0026] FIGS. 21 and 22 show a clamp and tool used to position and
crimp the clamp that can be used to secure an insert according to
the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0027] Turning now to the Figures, where the purpose is to describe
a preferred embodiment of the invention and not to limit same, FIG.
1 shows a tendon repair device 10 according to an aspect of the
invention. Device 10 has a support implant 11 having a body portion
12, with a first end 12A and second end 12B. The function of
support implant 11 is to be inserted into each end of a ruptured
tendon 1 so as strengthen the repair to the rupture in order to
help prevent the tendon from rupturing again prior to healing. Once
ruptured, the tendon has a first end 2 and another, second end 4.
The two ends must be connected to repair the rupture.
[0028] Implant 11 can be formed of any suitable bio-absorbable or
non-bio-absorbable material, and Implant may be a mesh like or
cloth like, flexible material. Textured edges, scalloping or other
physical characteristics may be present on implant 11 to increase
its friction with the tendon to help prevent slippage.
[0029] In one preferred embodiment, implant 11 comprises standard
suture material, which is either absorbable or nonabsorbable. Such
material includes threads that may be monofilament or polyfilament
braid or weave formed in approximately a 6 cm.times.3 mm mesh. The
insert may be tubular, or generally flat, or of any suitable
configuration.
[0030] Exemplary embodiments of implants according to various
aspects of the invention may include a fabric material. Such fabric
material may be woven, knitted, braided, and/or twisted. The fabric
may comprise any desired combination of absorbable and
non-absorbable materials, including silk, cotton, metal, and/or
synthetic fibers. The fabric may be of any suitable size, shape,
thickness, and density.
[0031] Examples of absorbable materials that may be used in
conjunction with embodiments of the invention include polyglactin,
polycaprolate, poliglecaprone, polysorb, polyglygolic acid,
polylactic acid, polydioxanone, caprolactone, collagen, surgical
gut, and combinations thereof. Examples of non-absorbable materials
that may be used in conjunction with embodiments of the invention
include polypropylene, polyester, nylon, silk, cotton, metal, and
combinations thereof.
[0032] The implant 11 could also be pretreated with an antibiotic
or growth enhancing substance. There are many
commercially-available pharmacological agents such as antibiotics
and therapeutic agents such as growth hormones and/or bioactive
molecules that may accelerate tendon healing. Additionally,
non-bioactive products may be incorporated into the implant to
physically strengthen the repair.
[0033] In the preferred embodiment, end 12A and 12B are each
attached to a separate needle 14. Each needle 14 is for being
inserted into one of the ends of the ruptured tendon 1 and to pull
body portion 12 of implant 11 into the first end 2 of the tendon
and the second end 4 of the tendon, respectively. Any suitable
needle or other device may be used for this purpose. It is
preferred, however, that the needle have a shape that predetermines
how far it penetrates along the length of each end of the tendon 1.
In the embodiment shown, each needle 14 has a relatively straight
portion 14A and a curved portion 14B, as best seen in FIGS. 1 and
8. Other devices for insertion of an insert 11 could be used, such
as reamers designed to open a path in the tendon for insert
placement.
[0034] The size and shape of needle 14 is determined by the size
and shape of the particular implant. In this current depiction, the
dimensions of needle 14 are 2 cm in length and 3 mm wide at the
portion to which the implant 11 is attached. The size and shape of
needle 14 depends on the size of the tendon to be repaired and the
type of implant used to support the ruptured area of the tendon.
Different needle lengths and sizes may be required for different
size tendons and different space requirements within the body.
[0035] Implant 11 has an outer surface 16. Outer surface 16
preferably has a surface that creates friction with the inner part
of the tendon 1, which outer surface 16 will contact when inserted
into tendon 1. The purpose of the friction is to bind implant 11
with the tendon to help insure the two do not separate and thus to
help strengthen the support provided by implant 11 at the rupture
site.
[0036] The outer surface 16 of implant 11 may have any one of or
combination of configurations to create friction. In the embodiment
shown in FIG. 3A the outer surface includes stiplets 18. In a
preferred embodiment, the stiplets 18 are between 1 mm and 2 mm in
height (as measured according to the distance from the main portion
16A of the outer surface), and most preferably about 0.5-2 mm in
height. The size of the stiplets may vary, however, according to
the size of the tendon and type of rupture being repaired. For
example, the stiplets may be between 0.5 mm and 4 mm in height and
between 0.5 mm and 4 mm in diameter at the base.
[0037] It is preferred that each stiplet 18 is between 0.5-5 mm in
distance from the next closest stiplet 18, although any suitable
distance may be selected. The implant could resemble a string of
pearls (as shown in FIGS. 3B and 15) which would have relatively
large variations between the larger stiplets and the smaller size
of the implant between the stiplets. It is also possible that
implant 11 could have a co-figuration such as a stiplets on a tape
strip or cord that might be, for example, 3 mm wide by lmm thick
and have with stiplets on either or both sides, or have a top
and/or bottom surface that is microtextured in any manner, and may
simply be the surface of a coarse, braided cloth material.
[0038] FIGS. 3B and 3C show implants that have ribbed outer
surfaces. In FIG. 3B the diameter of the main portion 16B of the
outer surface is relatively narrow, and each rib 20 has a height of
approximately 0.5 mm as measured from the main portion 16B,
although any suitable height may be utilized, such as between 1
mm-8 mm.
[0039] In FIG. 3C the diameter of the main portion 16C is larger
than the diameter of main portion 16B, and each rib 22 has a height
of approximately 0.5 mm as measured from the main portion 16C,
although any suitable height may be utilized, such as between 1
mm-8 mm.
[0040] FIG. 3D shows an implant with a serpentine outer wall 16D.
In this embodiment, the variation between the smallest diameter of
the implant and the lowest is about 0.5 mm to about 4 mm, although
any suitable dimensions, for example between 1 mm and 2 mm to 5 mm,
or 2 mm and 3 mm to 5 mm, may be used.
[0041] It is also possible to combine any of the concepts shown in
FIGS. 3A-3D, 14 and 15. For example, the implant 11 could have a
serpentine outer wall and also include stiplets and/or ribs.
Further, the implant may include backward angled barbs that allow
the implant to be pulled through the tendon, but that resist
removal when pulled in a direction against the barbs, as shown in
FIG. 14.
[0042] Once the implant 11 in positioned into each end 2 and 4 of
the ruptured tendon 1, the two ends 2 and 4 of the tendon 1 and the
implant 11 are mechanically attached in any suitable manner, such
as by suturing, stapling, or using surgical rivets or pins.
[0043] One method of effectuating a repair is shown in FIGS. 4-7.
FIG. 4 shows ends 2 and 4 of ruptured tendon 1 being initially
attached with a suture. FIG. 5 shows a needle 14 with end 12A of
implant 11 attached thereto being pushed through first end 2 of
tendon 1. This pulls part of the body portion 12 into the first end
2. When the needle 14 passes through the outer surface of tendon 1
it pulls the implant 11 with it. The implant material is cut away
from the needle 14, and preferably close to the outer surface of
the tendon 1.
[0044] This same procedure is repeated on end 4 of tendon 1.
[0045] Once the implant 11 is positioned in tendon 1, the ruptured
ends on the tendon and the implant are mechanically attached. As
shown in FIG. 7, this is done using any of the known tendon
suturing techniques. Any suitable technique, however, such as a
suturing technique, stapling, or other mechanical method of
attachment could be utilized. Adhesive might be used to augment the
repair. In this manner, the implant adds significant strength to
the rupture area and helps to prevent it from rupturing or pulling
apart partially to create a gap under a load prior to healing.
[0046] An alternate implant 30 is shown in FIGS. 16 and 17. Implant
30 is a hollow tube into which the first end 2 and second end 4 of
the ruptured tendon 1 are placed so they touch, and are preferably
pressed together. In this embodiment, there is an opening 31 along
one side of insert 30 to make placement of insert 30 around tendon
1 simple. The implant 30 has an inner surface 32 defining a cavity
34 that is dimensioned to receive each end 2 and 4 of ruptured
tendon 1. The tendon ends 2 and 4, and the implant 30 would then be
mechanically attached with any of the prior mentioned suture
techniques, staples, rivets, pins, clamps, or in any suitable
manner. Additionally, inner surface 32 may include apparatus 36
that enables each end 2 and 4 of tendon 4 to be inserted into
cavity 34, and that tend to hold the ends of the tendon in place
and resist the ends 2 and 4 from being removed from cavity 34.
[0047] For example, inner surface 32 could have structures 36 that
are backward-facing ribs or barbs as shown in FIG. 17A, which could
extend any suitable distance outward from inner surface 32. Such
structures could, for example, extend between 0.5 mm to 2 mm from
inner surface 32.
[0048] Once the ends 2 and 4 of tendon 1 have been inserted into
implant 30, the ends and implant 30 are mechanically attached in
the manner previously described with respect to implant 11.
[0049] Alternatively, an implant placed on the outside of tendon 1
may not have any openings, such as opening 31, as shown in
cross-sectional view 30A.
[0050] FIG. 9 shows needles 40 that can be used to secure a tendon
in place with ends 2 and 4 juxtaposed prior to or after an insert
11 or insert 30 has been placed in or on the tendon 1 and secured
thereto.
[0051] FIG. 10 depicts staples or rivets 45 that are placed by a
stapler 42 to secure a tendon and insert inside of or outside the
tendon according to methods and structures of the invention.
[0052] FIG. 11 shows rivets 45 positioned through an outer insert
30 and through a tendon 1 to hold insert 30 and ruptured ends 2 and
4 in place.
[0053] FIG. 12 shows another type of rivet 46 that can be used to
secure a ruptured tendon and insert in position.
[0054] FIG. 13 shows a method and structure by which a ruptured
tendon 1 is secured on spikes 50 to hold it in place. As shown in
this Figure, a knife or needle is pushed through tendon 1 to pull
insert 11 therethrough to strengthen the rupture area at ends 2 and
4. The tendon 1 and insert 11 are then mechanically secured using
any of the techniques described herein. However, pins or spikes may
be used to secure a tendon in place prior to repair using several
of the techniques described herein.
[0055] FIGS. 14 and 15, which have previously been described, show
alternate embodiments of insert 11 that is positioned inside of
tendon 1 to effectuate a rupture repair.
[0056] FIGS. 18-20 show alternate configurations of insert 11 that
may be positioned inside of tendon 1 to effectuate a rupture
repair. Any of these embodiments may include structures such as
stiplets, ribs, barbs or textured surfaces to secure them inside of
a tendon 1.
[0057] FIGS. 21-22 show a clamp 60 according to the invention and a
tool 70 that may be used to position and compress clamp 60. Clamp
60 and tool 70 are known to those skilled in the art.
[0058] Having thus described some embodiments of the invention,
other variations and embodiments that do not depart from the spirit
of the invention will become apparent to those skilled in the art.
The scope of the present invention is thus not limited to any
particular embodiment, but is instead set forth in the appended
claims and the legal equivalents thereof. Unless expressly stated
in the written description or claims, the steps of any method
recited in the claims may be performed in any order capable of
yielding the desired result.
* * * * *