U.S. patent application number 11/165551 was filed with the patent office on 2006-12-28 for tissue repair device.
Invention is credited to Raymond A. Bojarski, George Sikora.
Application Number | 20060293709 11/165551 |
Document ID | / |
Family ID | 37101998 |
Filed Date | 2006-12-28 |
United States Patent
Application |
20060293709 |
Kind Code |
A1 |
Bojarski; Raymond A. ; et
al. |
December 28, 2006 |
Tissue repair device
Abstract
A tissue repair device includes a closed knotless loop of
multifilament flexible material, and a fixation member having a
structure that defines a cavity that receives at least a part of
the closed loop. The tissue repair device may include a flexible
member traversing the loop. The loop may include a portion in which
ends of the multifilament flexible material are thermally fused
together. The multifilament flexible material may be braided or
twisted.
Inventors: |
Bojarski; Raymond A.;
(Attleboro, MA) ; Sikora; George; (Bridgewater,
MA) |
Correspondence
Address: |
FISH & RICHARDSON P.C.;SMITH & NEPHEW, INC.
1450 BROOKS ROAD
MEMPHIS
TN
38116
US
|
Family ID: |
37101998 |
Appl. No.: |
11/165551 |
Filed: |
June 24, 2005 |
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/0458 20130101;
A61B 2017/0475 20130101; A61B 2017/044 20130101; A61B 17/0401
20130101; A61B 2017/0477 20130101; A61B 2017/00004 20130101; A61B
2017/0464 20130101; Y10T 24/3916 20150115; A61B 2017/00526
20130101; A61B 17/0487 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A tissue repair device comprising a closed loop of multifilament
flexible material, wherein the loop is knotless and includes a
contact portion in which ends of the multifilament flexible
material are interwoven and melted-formed.
2. The tissue repair device of claim 1 further comprising a
fixation member having a structure that defines a cavity that
receives at least a part of the closed loop.
3. The tissue repair device of claim 1 further comprising a
flexible member traversing the loop.
4. The tissue repair device of claim 3 wherein the flexible member
traverses the loop by being passed through an interior defined by
the loop.
5. The tissue repair device of claim 3 wherein the flexible member
traverses the loop by being passed through the multifilament
flexible material.
6. The tissue repair device of claim 1 wherein the ends of the
multifilament flexible material are thermally fused together within
the contact portion.
7. The tissue repair device of claim 6 wherein the flexible member
traverses the loop by being passed through the thermally fused
portion of the multifilament flexible material.
8. The tissue repair device of claim 1 wherein the multifilament
flexible material is made of polymer-based compound.
9. The tissue repair device of claim 1 wherein the flexible member
traverses the loop by being passed through the interwoven portion
of the multifilament flexible material.
10. The tissue repair device of claim 1 wherein the multifilament
flexible material is braided.
11. The tissue repair device of claim 1 wherein the multifilament
flexible material is twisted.
12. A method of making a tissue repair device, the method
comprising: forming a closed loop from the multifilament flexible
material including: interweaving ends of the multifilament flexible
material together to form a contact portion without tying the ends
together in a knot, and causing the ends of the multifilament
flexible material to melt in the contact portion.
13. The method of claim 12 further comprising passing at least a
part of the multifilament flexible material through a cavity
defined by a fixation member.
14. The method of claim 12 further comprising traversing a flexible
member through the loop.
15. The method of claim 14 wherein traversing the flexible member
through the loop comprises passing the flexible member through an
interior defined by the loop.
16. The method of claim 14 wherein traversing the flexible member
through the loop comprises passing the flexible member through the
multifilament flexible material.
17. The method of claim 14 wherein traversing the flexible member
through the loop comprises passing the flexible member through the
contact portion of the multifilament flexible material.
18. The method of claim 12 wherein forming the closed loop includes
the thermally fusing the ends of the multifilament flexible
material in the contact portion.
19. The method of claim 12 wherein forming the closed loop from the
multifilament flexible material includes forming without applying a
filler material to the ends of the flexible element.
20. A tissue repair device comprising: a closed loop of
multifilament flexible material, wherein the loop is knotless and
includes a contact portion in which ends of the multifilament
flexible material are interwoven; and a fixation member having a
structure that defines a cavity that receives at least a part of
the closed loop.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application relates to U.S. application Ser. No.
09/704,926, which is incorporated herein by reference.
TECHNICAL FIELD
[0002] This description relates to tissue repair.
BACKGROUND
[0003] One area in the body where soft tissue is surgically
reattached to bone is the attachment of a rotator cuff tendon to
the humerus. The rotator cuff tendons have areas of low blood
supply. With an increased blood supply, a tissue, such as a tendon,
can repair and maintain itself better and faster. Thus, areas of
poor blood supply in the rotator cuff make these tendons difficult
and slow to heal following an injury, such as a tear to the
supraspinatus muscle or the subscapularis muscle. In such a tear,
part of the tendon is pulled away from the bone. Because of the
poor blood supply, rather than attempting to allow an injured
rotator cuff to heal on its own, a physician often recommends that
the tendon be surgically repaired to better fix the position of the
cuff to the bone to prevent further damage and improve the
environment for healing. For example, the physician may attempt to
fix the tendon to the bone using a fixation member such as a
retainer or an anchor. One example of a fixation member is
disclosed in U.S. Pat. No. 4,741,330 (the Hayhurst patent), which
is incorporated herein by reference.
[0004] Other areas in the body also have tissue that can be
surgically reattached to bone when torn from the bone or can be
surgically repaired when a tear forms in the tissue. These areas
include, for example, the biceps tendon, the lateral collateral
ligament in the knee, the medial collateral ligament in the knee,
the meniscus in the knee, the popliteal ligament in the leg, and
the labrum tendon in the knee.
[0005] Fibrous tissue wounds, such as muscle, ligament, and
cartilage tears, can be repaired arthroscopically using flexible
members such as sutures. Traditionally, to close a fibrous tissue
wound, a surgeon would insert two suture needles into the tissue
with sutures attached, thread the sutures across the wound, and
then tie knots to fix the free ends of the sutures within the
tissue.
[0006] To simplify the wound closure procedure and to improve
fixation, various types of fixation members have been developed.
One example of a fixation member in the form of a retainer is
disclosed in the Hayhurst patent. In the Hayhurst patent, one end
of a flexible member is fixed to a resiliently-deformable,
bar-shaped retainer. The retainer is loaded into the bore of a
hollow needle and deployed into or against the fibrous tissue. The
surgeon then threads the flexible member across the wound and
tensions a free end of the suture to pull the wound closed. When
the surgeon tensions the suture, the bar in the retainer becomes
oriented transversely to the suture hole, holding the suture in
place.
SUMMARY
[0007] In one general aspect, a tissue repair device includes a
closed loop of multifilament flexible material. The loop is
knotless and includes a contact portion in which ends of the
multifilament flexible material are interwoven and
melted-formed.
[0008] Implementations can include one or more of the following
features. For example, the tissue repair device can include a
fixation member having a structure that defines a cavity that
receives at least a part of the closed loop.
[0009] The tissue repair device can include a flexible member
traversing the loop. The flexible member can traverse the loop by
being passed through an interior defined by the loop. The flexible
member can traverse the loop by being passed through the
multifilament flexible material.
[0010] The ends of the multifilament flexible material can be
thermally fused together within the contact portion. The flexible
member can traverse the loop by being passed through the thermally
fused portion of the multifilament flexible material.
[0011] The multifilament flexible material can be made of
polymer-based compound.
[0012] The flexible member can traverse the loop by being passed
through the interwoven portion of the multifilament flexible
material. The multifilament flexible material can be braided or
twisted.
[0013] In another general aspect, a tissue repair device is made by
forming a closed loop from the multifilament flexible material. The
forming includes interweaving ends of the multifilament flexible
material together to form a contact portion without tying the ends
together in a knot, and causing the ends of the multifilament
flexible material to melt in the contact portion.
[0014] Implementations can include one or more of the following
features. For example, the method can also include passing at least
a part of the multifilament flexible material through a cavity
defined by a fixation member.
[0015] The method can include traversing a flexible member through
the loop. The traversing can include passing the flexible member
through an interior defined by the loop. The traversing can include
passing the flexible member through the multifilament flexible
material. The traversing can include passing the flexible member
through the contact portion of the multifilament flexible
material.
[0016] Forming the closed loop can include thermally fusing the
ends of the multifilament flexible material in the contact portion.
Forming the closed loop from the multifilament flexible material
can include forming without applying a filler material to the ends
of the flexible element.
[0017] In another general aspect, a tissue repair device includes a
closed loop of multifilament flexible material, and a fixation
member. The loop is knotless and includes a contact portion in
which ends of the multifilament flexible material are interwoven.
The fixation member has a structure that defines a cavity that
receives at least a part of the closed loop.
[0018] In another general aspect, a tissue repair device includes a
fixation member having a structure that defines a cavity, a
multifilament flexible element, and a flexible member. The
multifilament flexible element includes a part that is within the
cavity, and a thermally fused end. The flexible member passes at
least partially through the thermally fused end of the
multifilament flexible element.
[0019] Implementations can include one or more of the following
features. In particular, the multifilament flexible element
includes another thermally fused end and the flexible member passes
through the other thermally fused end of the multifilament flexible
element.
[0020] Aspects of the device and method may include one or more of
the following advantages. The ends of the multifilament flexible
material are thermally fused together without the use of a filler
material. The loop acts as a pulley that reduces pinching of the
flexible member between the tissue and the fixation member during
deployment. Additionally, the pulley design enables the flexible
member to slide relative to the fixation member without being
impeded by the edges of the fixation member or by the tissue when
the fixation member is deployed in tissue.
[0021] Other features will be apparent from the description, the
drawings, and the claims.
DESCRIPTION OF DRAWINGS
[0022] FIG. 1A is a perspective view of a tissue repair device.
[0023] FIG. 1B is an illustration of the tissue repair device of
FIG. 1A, shown mending a tear in soft tissue.
[0024] FIG. 1C is a perspective view of the tissue repair device of
FIG. 1A, shown mending a tear in soft tissue.
[0025] FIG. 2 is a side cross-sectional view of a fixation member
and a loop of the tissue repair device of FIG. 1A.
[0026] FIGS. 3A-3C are side perspective views showing formation of
a retaining element that can be formed in the tissue repair device
of FIG. 1A.
[0027] FIG. 4 is a flow chart of a procedure for forming the loop
in the tissue repair device of FIG. 1A.
[0028] FIGS. 5A-5E show perspective views of the multifilament
flexible material that is formed into the loop in the procedure of
FIG. 4.
[0029] FIG. 6 is a perspective view of another implementation of a
tissue repair device.
[0030] FIG. 7 is a perspective view of another implementation of a
tissue repair device.
[0031] Like reference symbols in the various drawings may indicate
like elements.
DETAILED DESCRIPTION
[0032] Referring to FIGS. 1A-1C and 2, a tissue repair device 100
includes a closed loop 105 of multifilament flexible material. The
loop 105 is knotless, that is, the loop 105 is formed without tying
ends of the multifilament flexible material together into a knot.
The multifilament flexible material is a material suitable for
implantation into hard or soft human tissue and it may be
absorbable or nonabsorbable. The multifilament flexible material
has two or more fibers or strands that are twisted, braided, or
otherwise interlinked about each other. The multifilament flexible
material is capable of being flexed or bent. The loop 105 is
closed, with a first end of the multifilament flexible material
contacts a second end of the multifilament flexible material to
form a contact portion 110.
[0033] The tissue repair device 100 also includes a fixation member
115 defining a cavity 120 that receives a part 125 of the loop 105.
As shown, the fixation member 115 can also include a second cavity
130 that receives another part 135 of the loop 105. The fixation
member 115 can be made of any rigid material suitable for
implantation into hard or soft human tissue. For example, the
fixation member 115 can be made of a biocompatible plastic, a
biocompatible metal, or a bioabsorbable polymer.
[0034] The fixation member 115 can be formed as a retainer that is
transferred through a tear 160 in tissue 165 and held at an outer
surface 170 of the tissue 165 after deployment, as shown in FIGS.
1B and 1C.
[0035] The fixation member 115 can be formed as an anchor or a
screw that is drilled or driven into the tissue during deployment,
as shown in FIG. 15 of U.S. application Ser. No. 09/704,926. In an
anchor or screw form, the fixation member 115 can include one or
more threads on its outer surface to facilitate holding of the
fixation member 115 to the tissue. Such anchor or screw forms are
particularly adapted for use in hard tissue such as bone. The
fixation member 115 can be formed with a generally cylindrical
shape for receipt within a delivery device, such as a needle. The
fixation member 115 can have a fin extending from its generally
cylindrical shape.
[0036] The tissue repair device 100 also includes a flexible member
140, for example, a suture, that traverses the loop 105. As shown
in FIGS. 1A and 1B, the flexible member 140 traverses the loop 105
by being passed through an interior 145 of the loop 105 that is
bounded by or enclosed by the loop 105 and the fixation member 115.
The flexible member 140 is a material suitable for implantation
into hard or soft human tissue and it may be absorbable or
nonabsorbable in the tissue after implantation. For example, the
flexible member 140 can be made of a natural material, such as, for
example, collagen, surgical silk, surgical cotton, or surgical
steel. As another example, the flexible member 140 can be made of a
synthetic material, such as, for example, a polymer or nylon.
[0037] Referring also to FIGS. 3A-3C, the tissue repair device 100
can include a second fixation member 150 through which the flexible
member 140 is passed, and a retaining element 300, for example, a
slip knot in the flexible member 140. The flexible member 140 is
passed through the fixation member 150 by threading the flexible
member 140 through a hole within the fixation member 150 and then
attaching an end of the flexible member 140 to a region of the
flexible member 140 that has not been threaded through the fixation
member 150. The retaining element 300 permits the flexible member
140 to be pulled in the direction of arrow 305 and pass through the
retaining element 300, thus reducing the distance between the
fixation member 115 and the fixation member 150 and causing sides
of the tear 160 to come into contact with each other. The retaining
element 300 prevents an increase in distance between the fixation
member 115 and the fixation member 150 to prevent the sides of the
tear 160 from coming apart after coming in contact with each
other.
[0038] Examples of the fixation members 115, 150, the retaining
element 300, and the flexible member 140 can be found in U.S.
application Ser. No. 10/918,445, filed Aug. 16, 2004, which is
incorporated herein by reference.
[0039] Referring to FIGS. 4 and 5A-5E, a procedure 400 is performed
to form the loop 105. Initially, a first end 510 of the
multifilament flexible material 500 is inserted or passed through
the cavity 120 of the fixation member 115 (step 405). If desired,
the multifilament flexible material 500 can be inserted through the
second cavity 130 of the fixation member fixation member 115. After
insertion, the first end 510 of the material 500 is brought into
contact with a second end 505 (step 410). To facilitate thermal
fusion, the ends 505, 510 can be interwoven into each other to make
contact, as shown in FIG. 5B. In this case, the fibers of the end
505 are interwoven with the fibers of the end 510. For example, the
end 505 can be inserted between fibers of the end 510, as shown in
FIG. 5B. As another example, the end 505 can be inserted through an
interior of a Chinese trap formed at the end 510, as shown in FIG.
5C.
[0040] Next, energy is supplied to the ends 505, 510 until the
temperature of the ends 505, 510 raises to the point that the
material in the ends 505, 510 melts or liquefies (step 415). At
this point, the ends 505, 510 blend together to form a blended
region, that is, a uniform or homogenous composition. Energy is
supplied to the ends 505, 510 using, for example, thermal energy,
ultrasonic energy, laser light, or electrical arc discharge. The
ends 505, 510 can be inserted in a suitable energy supplying
apparatus, depending on the way in which energy is provided to the
ends 505, 510. For example, if the energy supplied is thermal
energy, the ends 505, 510 can be locally heated using a heater
element such as an electrical resistance heater element in the form
of a thin film of an alloy. The heater element can create heat by
other means, such as by induction, irradiation, or a chemical
reaction. The blended region is allowed to cool to form a solid
blended composition in the contact portion 110 (step 420).
[0041] The multifilament flexible material can be any material that
is able to melt or liquefy upon application of an energy that
raises its temperature and to solidify upon cooling such that the
multifilament flexible material forms a blended region. Examples of
materials having these properties include nylon, metals (such as
titanium or steel), and polymer-based compounds, such as polyester
fiber, polypropylene, polybutester, polyglactin, poliglecaprone,
and polydioxanone. Another material that may have these properties
is natural silk protein produced by spiders. The multifilament
flexible material 500 can be any length and diameter that enables
passage through the fixation member 615 and subsequent thermal
fusion. For example, in one implementation in which the flexible
material 500 is a type 0 size, the material 500 is about 4-12 mm
long and has a diameter of about 0.4 mm.
[0042] The procedure 400 produces a contact portion 110 that has a
yielding strength that is equivalent to or near to the United
States Pharmacopoeia (USP) Standards value for a particular size of
suture. For example, for a USP type 0 size suture, the yielding
strength of the contact portion is about 12-13 pounds.
[0043] Referring to FIG. 6, in another implementation, a tissue
repair device 600 includes a closed loop 605 of multifilament
flexible material, similar in design to the loop 105 described
above. The loop 605 is closed, thus, a first end of the
multifilament flexible material contacts a second end of the
multifilament flexible material to form a contact portion 610. One
or more of the ends of the multifilament flexible material may
include a Chinese trap.
[0044] The tissue repair device 600 also includes a fixation member
615 defining a cavity 620 that receives a part 625 of the loop 605,
as discussed above with respect to FIG. 2. The tissue repair device
600 also includes a flexible member 640 that traverses the loop
605. As shown, the flexible member 640, in this implementation,
traverses the loop 605 by passing through the contact portion 610
of the multifilament flexible material rather than passing through
the interior of the loop 605. In this way, the flexible member 640
freely moves through the contact portion 610. For example, if the
contact portion 610 includes a Chinese trap, then the flexible
member 640 would pass directly through the Chinese trap.
[0045] Referring again to FIGS. 1B and 1C, the loop 105, 605 acts
like a pulley through which the flexible member 140, 640 can freely
slide to facilitate deployment of the fixation member 115, 615 into
tissue 165. The pulley design reduces pinching of the flexible
member 140, 640 between the surface 170 of the tissue 165 and the
fixation member 115, 615 during deployment. Additionally, the loop
105 reduces friction between the flexible member 140, 640 and the
fixation member 115, 615, thus enabling the flexible member 140,
640 to slide without being impeded by the edges of the fixation
member 115, 615 or by the tissue 165 when the fixation member 115,
615 is deployed in tissue 165. Other pulley designs are shown in
U.S. application Ser. No. 09/704,926. The device 100 or 600 can be
delivered to the tissue 165 using a delivery device, such as, for
example, the delivery devices shown in FIGS. 3, 5, 6, and 8-11 of
U.S. application Ser. No. 09/704,926.
[0046] Referring to FIG. 7, in another implementation, a tissue
repair device 700 includes a multifilament flexible element 705
having a thermally fused end 710 and a part 725 that is within a
cavity 720 defined by a fixation member 715. Unlike the ends 505,
510 of the multifilament flexible material of the loop 105, the end
710 is thermally fused without being contacted to a second end 712
of the element 705. In this implementation, energy is supplied to
the end 710 until the temperature of the end 710 raises to the
point that the material in the end 710 melts or liquefies and
blends together to form a blended, uniform composition. Energy may
be supplied in any one of the manners mentioned above. Next, the
blended composition at the end 710 is allowed to cool to form a
solid blended composition.
[0047] The multifilament flexible element 705 can be any length and
diameter that facilitates passage through the fixation member 715
and subsequent thermal fusion of the end 710. For example, in one
implementation in which the flexible material 705 is a type 0 size,
the material 500 is about 4-12 mm long and has a diameter of about
0.4 mm.
[0048] The tissue repair device 700 includes a flexible member 740
that is passed at least partially through the thermally fused end
710 by, for example, threading the flexible member 740 through the
end 710 using a needle. After the flexible member 740 is passed
through the end 710, it is free to move relative to the end 710.
Thus, the multifilament flexible element 705 acts like a pulley
through which the flexible member 740 can freely slide to
facilitate deployment of the fixation member 715 into tissue.
[0049] To improve pullout strength between the flexible member 740
and the flexible element 705, the second end 712 of the element 705
can also be thermally fused (as discussed above with respect to the
end 710) and the flexible member 740 can be passed through the
thermally fused end 712, as shown.
[0050] Other implementations are within the scope of the following
claims.
[0051] For example, the multifilament flexible material or the
contact portion may include a growth factor, such as, for example,
an angiogenic factor. The multifilament flexible material or the
contact portion may be loaded with a bioactive material, a
stimulant, or any substance that promotes healing of the
tissue.
[0052] As another example, the contact portion can be formed by
stitching the ends of the multifilament flexible material together
without raising the temperature at the ends by using an additional
element of similar ligature as the thread. For example, if the
multifilament flexible material is a type 0 size, then the thread
can be a high strength polyethylene suture of 2-0, 4-0, or 8-0 size
using the USP standards.
* * * * *