U.S. patent application number 13/796607 was filed with the patent office on 2014-06-12 for tissue repair devices and methods.
The applicant listed for this patent is Dolly Jeanne Holt. Invention is credited to Dolly Jeanne Holt.
Application Number | 20140163586 13/796607 |
Document ID | / |
Family ID | 50881775 |
Filed Date | 2014-06-12 |
United States Patent
Application |
20140163586 |
Kind Code |
A1 |
Holt; Dolly Jeanne |
June 12, 2014 |
TISSUE REPAIR DEVICES AND METHODS
Abstract
Devices and methods for reconnecting or supporting torn, damaged
or weak tissue are disclosed. The disclosed embodiments can be used
on long slender tissue such as ligaments, tendons, nerves, vessels,
intestines, muscles, bones, appendages and any other elongate
tissue within the body, of both humans and other animals. The
devices can wrap around elongate tissue and is capable of
supporting the tissue or keeping two severed ends in close
proximity to one another. The devices can be used in addition to or
in lieu of sutures. The devices can function similar to a Chinese
Finger Trap and are capable of decreasing in diameter upon
extension, thus constricting upon the tissue. The multiple coils of
the devices can make sufficient surface contact on the ligament or
tendon, using friction to keep the device in place, while also
allowing access for diffusion of oxygen and nutrients.
Inventors: |
Holt; Dolly Jeanne; (Salt
Lake City, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Holt; Dolly Jeanne |
Salt Lake City |
UT |
US |
|
|
Family ID: |
50881775 |
Appl. No.: |
13/796607 |
Filed: |
March 12, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61736000 |
Dec 11, 2012 |
|
|
|
Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/083 20130101;
A61B 17/1146 20130101; A61B 17/11 20130101; A61B 2017/1132
20130101; A61F 2/0811 20130101; A61B 2017/0649 20130101; A61B
17/1128 20130101; A61B 17/064 20130101; A61B 2017/1103 20130101;
A61B 17/1114 20130101; A61B 2017/1107 20130101; A61B 17/1227
20130101; A61B 2017/00526 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61F 2/00 20060101
A61F002/00 |
Claims
1. A tissue repair device comprising: a coil comprising a plurality
of interconnected turns in series, the coil formed of an elongate
coil member of biocompatible material, the coil member having a
first end and a second end and configured in a spiral pattern to
form the series of interconnected turns of the coil and define a
lumen through the coil, the lumen being open at both ends and
configured to receive and encircle an elongate tissue to be
repaired, the coil being extendable to increase a distance between
adjacent turns of the plurality of turns and increase a length of
the coil, wherein each turn of the plurality of the turns of the
coil has a first diameter when the coil is in a relaxed state, the
diameter configured to engage the elongate tissue in the relaxed
state and configured to reduce to a second diameter smaller than
the first diameter when the coil is in an extended state to more
tightly engage the elongate tissue, wherein turns of the coil at a
first end of the coil are configured to engage a first portion of
the elongate tissue and turns of the coil at a second end of the
coil engaging a second portion of the elongate tissue such that a
tension on the elongate tissue pulling the first portion in
direction away from the second portion of the elongate tissue
extends the coil, thereby reducing the diameter of turns of the
plurality of turns of the coil member to more tightly engage the
elongate tissue and decrease tension at a wound site of the
elongate tissue by distributing tension along a length of the
coil.
2. The tissue repair device of claim 1, wherein the plurality of
turns of the coil member define a lumen configured to receive and
encircle an elongate tissue of human and animal origin that is one
of a ligament, a tendon, a nerve, a vessel, an intestine, a muscle,
an appendage, and a bone.
3. The tissue repair device of claim 1, wherein the lumen has a
first open end and a second open end, the first open end being one
of circular, elliptical, square, rectangular, triangular, and
trapezoidal and the second open end being one of circular,
elliptical, square, rectangular, triangular, and trapezoidal.
4. The tissue repair device of claim 1, wherein the elongate coil
member is formed of one of a metal, a polymer, and a ceramic.
5. The tissue repair device of claim 1, wherein the coil member is
biodegradable.
6. The tissue repair device of claim 5, wherein the coil member
further comprises one or more of a medicament and a nutrient to
enhance tissue regeneration.
7. The tissue repair device of claim 1, wherein the coil member is
drug-eluting to promote tissue regeneration.
8. The tissue repair device of claim 1, wherein the coil member is
porous to promote cellular in-growth.
9. The tissue repair device of claim 1, wherein spacing between
adjacent turns of the plurality of turns of the coil, in the
relaxed state, varies along a length of the coil.
10. The tissue repair device of claim 1, wherein a transverse
cross-sectional area of the lumen through the coil varies along a
length of the coil.
11. The tissue repair device of claim 1, wherein the cross
sectional area of the lumen of the coil at a first end is smaller
than at a second end.
12. The tissue repair device of claim 1, wherein the cross
sectional area of the lumen of the coil is smaller at a center
region of the coil and larger towards ends of the coil.
13. The tissue repair device of claim 1, where the cross sectional
area of the lumen of the coil is larger in the center of the coil
and smaller towards the two outside ends.
14. The tissue repair device of claim 1, wherein a thickness of the
coil member varies along a length of the coil.
15. The tissue repair device of claim 1, wherein a transverse
cross-section of the coil member is one of circular, elliptical,
square, rectangular, triangular, trapezoidal, or a combination and
the second open end being one of circular, elliptical, square,
rectangular, triangular, and trapezoidal.
16. The tissue repair device of claim 1, wherein the coil member
has one of nano-, micro-, meso- and macro-textured surfaces.
17. The tissue repair device of claim 1, wherein the coil member is
coated with a coating comprising one or more of cells, a chemical,
a mineral, a natural polymer, a synthetic polymer, a protein, a
carbohydrate, and a sugar.
18. The tissue repair device of claim 17, wherein the coating is
applied to an inner surface of the coil.
19. The tissue repair device of claim 1, wherein the coil member is
formed by wrapping a polymer around a dowel and allowing the
polymer to cure.
20. The tissue repair device of claim 1, wherein the coil member is
configured to remain engaged around the elongate tissue, with an
inner surface of the plurality of turns engaging the elongate
member using principles of friction and constriction, independent
of sutures through the elongate tissue.
21. A method of supporting tissue, the method comprising: obtaining
a tissue repair device comprising a coil formed by an elongate coil
member of biocompatible material having a first end and a second
end and configured in a spiral pattern to form a series of
interconnected turns and to define a lumen through the coil member
being open at both ends to receive, encircle, and engage target
elongate tissue to be treated; accessing within the body the target
elongate tissue; and positioning the tissue repair device with the
coil around the target elongate tissue, with the target elongate
tissue disposed through the lumen with an inner surface of the
series of interconnected turns engaging the target elongate
tissue.
22. The method of claim 21, wherein supporting tissue comprises
connecting together a first free end and a second free end of a
torn elongate tissue, the method further comprising: drawing
together the first free end and the second free end of the torn
elongate tissue to be connected, and wherein positioning the tissue
repair device includes positioning the first and second free ends
to be connected within the lumen with an inner surface of the
series of interconnected turns engaging the target elongate tissue
and maintaining the first free end and the second free end of the
target elongate tissue in close proximity to each other.
23. The method of claim 21, wherein the coil is extendable from a
relaxed state to an extended state and each turn of the series of
interconnected turns has a first diameter when in a the relaxed
state and a second smaller diameter when in the extended state.
24. The method of claim 21, wherein the tissue repair device is
configured such that tensile stress on the elongate tissue extends
the coil to the extended state and thereby distributes tension
resulting from the tensile stress along the target elongate tissue
through a length of the coil.
25. The method of claim 21, wherein the tissue repair device is
configured such that a first end can be mounted to a bone and a
second end can encircle soft tissue and thereby relieve tension at
the bone-soft tissue interface.
26. The method of claim 21, wherein positioning the tissue repair
device comprises: engaging a first end of the coil member of the
tissue repair device with the target elongate tissue; and twisting
the coil member of the tissue repair device onto the target
elongate tissue to position the target elongate tissue through the
lumen with an inner surface of the series of interconnected turns
engaging the target elongate tissue.
27. The method of claim 21, wherein positioning the tissue repair
device comprises: twisting the coil member in a direction opposite
a direction of the spiral pattern to increase a diameter of one or
more turns of the series of interconnected turns to allow
positioning of the coil around the target elongate tissue, with the
injured tissue disposed within the lumen of the tissue repair
device and an inner surface of the series of interconnected turns
engaging the target elongate tissue.
28. The method of claim 21, wherein positioning the tissue repair
device comprises: attaching sutures to ends of the elongate tissue
to be joined and passing a free end of the sutures that are not
attached to elongate tissue through the tissue repair device in
opposite directions and pulling the ends of the elongate tissue
into the tissue repair device.
29. A method of connecting tissue, the method comprising: obtaining
a tissue repair device comprising a coil formed by an elongate coil
member of biocompatible material having a first end and a second
end and configured in a spiral pattern to form a series of
interconnected turns and to define a lumen through the coil member
being open at both ends to receive, encircle, and engage target
elongate tissue to be treated; accessing within the body the target
elongate tissue; drawing together a first free end and a second
free end of the target elongate tissue to be connected; and
positioning the tissue repair device with the coil around the
target elongate tissue with the target elongate tissue, including
the first and second free ends to be connected, disposed within the
lumen with an inner surface of the series of interconnected turns
engaging the target elongate tissue and maintaining the first free
end and the second free end of the target elongate tissue in close
proximity.
Description
RELATED APPLICATIONS
[0001] The present application claims benefit of priority under 35
U.S.C. .sctn.119(e) of U.S. Provisional Patent Application No.
61/736,000, filed Dec. 11, 2012, and entitled "RECOMBINATION AND
SUPPORT DEVICES AND METHODS FOR INJURED TISSUE," which is hereby
incorporated herein by reference in its entirety.
TECHNICAL FIELD
[0002] This disclosure relates generally to the field of surgery.
More particularly it relates to devices and methods to support weak
tissue or for moving two regions of tissue towards each other to
reconnect or support tissue that is separated or at risk of
separation.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] The written disclosure herein describes illustrative
embodiments that are non-limiting and non-exhaustive. Reference is
made to certain such illustrative embodiments that are depicted in
the figures, in which:
[0004] FIG. 1A is a perspective view of a tissue repair device,
according to one embodiment of the present disclosure.
[0005] FIG. 1B is a side view of a tissue repair device, according
to one embodiment, in a relaxed state.
[0006] FIG. 1C is a side view of a tissue repair device, according
to one embodiment, in an extended state and having a decreased coil
diameter upon extension.
[0007] FIG. 2 is a side view of a tissue repair device, according
to one embodiment, encircling severed or injured tissue.
[0008] FIG. 3 is illustrates tension distribution within a tissue
repair device during extension, in which tension is distributed
circumferentially and alleviates tension at the wounded site of the
tissue.
[0009] FIG. 4 illustrates a side view of a tissue repair device,
according to one embodiment, encapsulating frayed tissue.
[0010] FIG. 5 is a perspective view of a tissue repair device,
according to another embodiment, having a larger diameter at a
first end of the device and a smaller diameter at an opposite
second end of the device.
[0011] FIG. 6 is a perspective view of a tissue repair device,
according to another embodiment, having a smaller diameter at a
center portion and larger diameters towards each end.
[0012] FIG. 7 is a perspective view of a tissue repair device,
according to another embodiment, having a larger diameter at a
center portion and smaller diameters towards each end.
[0013] FIG. 8 shows various shaped transverse cross-sectional areas
of a coil member of a tissue repair device.
[0014] FIG. 9 shows transverse cross-sectional views of various
tissue repair devices, illustrating varying shaped lumens of tissue
repair devices.
[0015] FIGS. 10A-10D are cross-sectional views of various
embodiments of a coil member of a tissue repair device, showing the
coil member with a macro or micro texture on all or part of a
surface.
[0016] FIGS. 11A-11D are cross-sectional views of a coil member of
various embodiments of a tissue repair device, showing the coil
member with a coating on all or part of a surface.
[0017] FIG. 12A is a side view of a tissue repair device encircling
and engaged with an elongate tissue.
[0018] FIG. 12B is a side view of the tissue repair device of FIG.
12A in an extended state engaging the elongate tissue is it is
extended.
[0019] FIG. 13A illustrates deployment of a tissue repair device
onto a partial or full tissue tear of an elongate tissue by
twisting the coil onto the elongate tissue.
[0020] FIG. 13B illustrates the tissue repair device of FIG. 13A
positioned in place on injured elongate tissue.
[0021] FIG. 13C illustrates the healed elongate tissue after the
tissue repair device dissolves or is removed.
[0022] FIG. 14A illustrates deployment of a tissue repair device by
reversing the twist in the coil, to increase a diameter of the
turns of the coil to more easily place the injured elongate tissue
within a lumen of the coil.
[0023] FIG. 14B illustrates the tissue repair device of FIG. 14A in
place on the injured elongate tissue.
[0024] FIG. 14C illustrates the healed tissue after the tissue
repair device dissolves or is removed.
[0025] FIG. 15A illustrates a method of connecting sutures to
either end of a severed elongate tissue and threading the sutures
through a tissue repair device.
[0026] FIG. 15B illustrates the injured elongate tissue pulled
through the tissue repair device of FIG. 15A using the sutures.
[0027] FIG. 15C illustrates the injured tissue in place within the
tissue repair device of FIG. 15A.
[0028] FIG. 16 is a flow diagram of a manufacturing process for
producing a tissue repair device, according to one embodiment, by
using an injection molding system.
[0029] FIG. 17 is a flow diagram of a manufacturing process for
producing a tissue repair device, according to one embodiment, by
wrapping an extruded polymer around a heated dowel or heating the
polymer and wrapping it around a dowel.
[0030] FIG. 18 is a flow diagram of a manufacturing process for
producing a tissue repair device, according to one embodiment, by
wrapping metal around a heated dowel or heating the metal and
wrapping it around a dowel.
[0031] Other features of the present embodiments will be apparent
from the accompanying drawings and from the detailed description
that follows.
DETAILED DESCRIPTION
[0032] Soft tissue injuries such as lacerations of ligaments and
tendons can be repaired using sutures. However, when the tissue is
under stress such as tensile stress, high tension can result at
discrete suture sites and cause sutures to tear through the tissue.
Torn tissue can require a repeat surgery to be repaired. The
disclosed tissue repair devices can be used to effectively ligate
and/or support torn or otherwise damaged tissue. The disclosed
tissue repair devices distribute tension along repaired tissue and
thus decrease the risk of injured tissue being torn after
repair.
[0033] Soft tissue tears, such as tears of the Patellar and
Achilles tendon rupture, can result in "mop ends" or frayed edges
at the torn ends. These frayed ends can be time consuming and
difficult to suture together, particularly in a manner to promote
healing of the tear. The disclosed tissue repair devices can gather
frayed mop ends and promote healing.
[0034] The disclosed tissue repair devices and methods can also be
used to connect or support other elongate tissue within the body
such as nerves and blood vessels. Sutures injure tissue in order to
remain fixed in place. The disclosed tissue repair devices and
methods of treatment can connect or support weak, damaged, or
severed tissue while causing minimal or no damage to the
tissue.
[0035] The present disclosure provides tissue repair devices for
recombining, reconnecting and/or supporting torn, damaged or weak
tissue. Specifically the disclosed devices can be used on elongate,
slender tissue such as ligaments, tendons, nerves, vessels,
intestines, muscles, bones, appendages and any other elongate
tissue within the body. The devices can be used in both humans and
animals. The present disclosure also provides methods for
recombining, reconnecting or supporting torn, damaged or weak
tissue, including administering the disclosed devices onto damaged
tissue. The present disclosure also provides manufacturing
processes for the creation of a device to reconnect damaged
tissue.
[0036] The disclosed embodiments offer improved distribution of
tension compared to sutures to prevent tissue from tearing under
stress.
[0037] The disclosed embodiments do not need to pierce the tissue
to remain in place.
[0038] The disclosed embodiments may reconnect or support tissue
that is separated or at risk of separation.
[0039] In accordance with the principles of the present disclosure,
the disclosed embodiments decrease tension at the wound site by
distributing tension along the device and alleviating direct
tension on the tissue.
[0040] The disclosed embodiments can encircle and engage or grip
elongate tissue, using principles of friction and constriction,
without causing damage to the tissue, for example, to support the
damaged elongate tissue and/or to maintain two separated ends of
the elongate tissue in close proximity to one another. The
disclosed embodiments can provide mechanical support, stability,
and the introduction of biologics such as proteins, cells, and
growth factors to injured tissue. The disclosed embodiments may
facilitate healing by allowing nutrients and oxygen to diffuse into
the tissue through the gaps in the coils. For example, the
disclosed embodiments may be porous, drug-eluting, and/or otherwise
enhanced to promote tissue regeneration and cellular growth of the
damaged tissue.
[0041] The disclosed embodiments may facilitate early mobilization
of the injured tissue by stretching and moving with the tissue. The
disclosed embodiments may reduce time to repair torn and injured
tissue, compared to suturing and other methods. The disclosed
embodiments may be used in conjunction with or in place of
sutures.
[0042] The disclosed embodiments can be connected directly to soft
tissue, and may not involve mounting to, for example bone, thus,
limiting or even preventing any damage to the bone growth plate.
The disclosed embodiments may enable tendons or ligaments that
become frayed and swollen to be enclosed within a coil to more
easily slide within the tight sheath. The disclosed embodiments may
also facilitate manipulation of the severed tendon through the
sheath during surgery.
[0043] One embodiment may be connected to soft tissue at a first
end and bone at a second end to reduce tension at the soft
tissue-bone interface.
[0044] The disclosed embodiments can encapsulate frayed mop ends of
a ligament or tendon, thus reducing the need for complex suturing
and decreasing risk of scar adhesion within the tissue sheath.
[0045] The disclosed embodiments can constrict upon a suture site
so that the tendons can glide more readily within the sheath.
[0046] The disclosed embodiments may allow soft tissue to press up
or outward between the coils, creating multiple catch points to
inhibit or even prevent the tissue from slipping within the
coil.
[0047] The disclosed embodiments may decrease in diameter upon
extension, constricting on the elongate tissue and remaining in
place even during extension. In particular, a lumen through the
device may decrease in diameter upon extension. This decrease in
diameter upon extension, can accommodate the decrease in diameter
of elongate tissue that may occur when the elongate tissue is
extended, thus allowing the device to maintain proper contact and
engagement during extension and relaxation of the elongate tissue.
The disclosed embodiments may employ principles of friction and
constriction to remain in place and maintain contact with injured
tissue.
[0048] The disclosed embodiments may increase in diameter during
relaxed states, allowing for the least constriction and maximum
diffusion of nutrients to the damaged tissue within the device.
[0049] The disclosed embodiments can be made of biodegradable
polymers that can be broken down by the body after the injured
tissue is sufficiently healed, allowing the native tissue to return
to its normal state. Examples of polymers and constituents of
co-polymers that can be used are polycaprolactone, polyurethane,
polylactic acid, polyglycolic acid, polyvinyl alcohol,
polyvinylpyrrolidone, polyester, and poly(hydroxyalkanoate).
[0050] The disclosed embodiments can be made of naturally
biodegradeable materials that can be broken down by the body after
the injured tissue is healed, allowing the native tissue to return
to its normal state. Examples of natural materials that can be used
are extracellular matrix proteins such as collagen, fibronectin,
fibrinogen, lamanin, elastin, keratin and polysaccharides, such as
starch, cellulose, and chitosan.
[0051] The disclosed embodiments can also be infused with, or
otherwise include nutrients, supplements, medicaments, sugars,
growth factors, proteins, and/or hormones, which may promote and
enhance healing of the elongate tissue. For example, as the
biodegredable polymers and/or natural materials may include
elements to promote tissue growth and/or healing that may be
released as the biodegradeable polymers and/or natural materials
are broken down by the body.
[0052] The disclosed embodiments can be made of non-biodegradable
polymers that will remain in place to continue to support the
injured tissue. Examples of polymers and constituents of
co-polymers that can be used are polytetrafluoroethylene,
polyurethane, polystyrene, polycarbonate, polyester, polysulfone,
polyethylene terephthalate, polyethylene, polypropylene,
polyurethane, silicone, polydimethylsiloxane,
polymethylmethacrylate, and polyhydroxyethyl methacrylate, and
polyetheretherketone.
[0053] The disclosed embodiments can be made of metals or metal
alloys that will remain in place to continue to support the injured
tissue. Examples of metals or constituents of metal alloys that can
be used include nitinol, stainless steel, cobalt, chromium,
titanium, platinum, iridium, tungsten, tantalum, aluminum,
vanadium, molybdenum, silver, copper, silicon, and tin.
[0054] The disclosed embodiments can be made of metals or metal
alloys that can degrade. Examples of metals or components in metal
alloys that can be used include iron, magnesium, silicon, cobalt,
tungsten, boron, carbon, lead, and sulfur.
[0055] The disclosed embodiments can be made of a ceramic that can
be degradable or non-degradable. Examples of ceramics include
hydroxyapetite, bioglass, calcium phosphate, titanium nitride,
tungsten carbide, titanium carbon nitride, aluminas, SiO.sub.2,
Na.sub.2O, CaO, P.sub.2O.sub.5 and zirconia.
[0056] The disclosed embodiments may include deployment during
surgery by positioning the open end of the coil at one of the ends
onto the tissue and twisting the coil onto the tissue much like
twisting a key ring onto a key.
[0057] The disclosed embodiments may involve twisting the coil onto
the ligament or tendon, which may allow the device to be deployed
at a site of a partial tear and complete tear of the injured
elongate tissue.
[0058] The disclosed embodiments may include deployment during
surgery by suturing each end of the severed tissue and using the
sutures to pull the tissue into the lumen of the coiled device.
[0059] The disclosed embodiments may include deployment by
reversing the coil of the device to increase the diameter of the
coil to more easily allow insertion of wounded tissue.
[0060] The presently disclosed embodiments of devices may be
created using injection molding processes.
[0061] The presently disclosed embodiments of devices can be
created by wrapping extruded polymer around a dowel.
[0062] The presently disclosed embodiments of devices can be
created by wrapping metal around a dowel.
[0063] Certain embodiments of the present disclosure will now be
discussed with reference to the accompanying drawings and reference
numerals provided therein so as to enable one skilled in the art to
practice the present invention. The drawings and descriptions are
examples of various aspects of the invention and are not intended
to narrow the scope of the claims to the inventions. Also, for the
sake of simplicity, the illustrated devices and tissue may be
represented as cylindrical in shape, however each of these
embodiments can be altered to accommodate a device and tissue shape
that is not cylindrical.
[0064] FIG. 1A is a perspective view of a tissue repair device 100,
according to one embodiment. The tissue repair device 100 comprises
a coil or spiral shape formed by a coil member 103 arranged in a
coil or spiral to form a plurality of interconnected turns 106 that
creates a lumen 105 at its center. The tissue repair device 100 can
have a length of X and spacing of Y between the turns 106 of the
coil 105 of the device 100. The spacing Y between the turns 106 can
vary along the length X of the tissue repair device 100. The coil
member 103 has a thickness Z, which can vary along the length X of
the device 100. A diameter W of the turns 106 of the coil member
103 can be varied along the length X of the device 100, which
correspondingly varies the diameter of the lumen 105. FIG. 1B shows
a tissue repair device 100, according to one embodiment, in a
relaxed state in which the coil has a first (relaxed) coil diameter
W.sub.R and a first relaxed length X.sub.R. FIG. 1C shows the
tissue repair device 100 of FIG. 1B in an extended state and
illustrates a resultant decrease in coil diameter W, to a second
(extended) coil diameter W.sub.E and an extended length X.sub.E, as
seen compared to the relaxed coil diameter W.sub.R and relaxed coil
length X.sub.R. The tissue repair device 100 may approximate or
function in a manner similar to a "Chinese finger trap" in concept
by reducing in diameter upon extension, allowing the device to
accommodate any decrease in diameter seen in the elongate tissue
such as a ligament or tendon during extension.
[0065] The coil member 103 may be formed of a biodegradable
polymers and/or natural materials that can be broken down by the
body after the injured tissue is sufficiently healed, allowing the
native tissue to return to its normal state. Examples of polymers
and constituents of co-polymers that can be used are
polycaprolactone, polyurethane, polylactic acid, polyglycolic acid,
polyvinyl alcohol, polyvinylpyrrolidone, polyester, and
poly(hydroxyalkanoate). Examples of natural materials that can be
used are extracellular matrix proteins such as collagen,
fibronectin, fibrinogen, lamanin, elastin, keratin and
polysaccharides, such as starch, cellulose, and chitosan.
[0066] The coil member 103 can be infused with, or otherwise
include nutrients, supplements, medicaments, sugars, growth
factors, proteins, and/or hormones, which may promote and enhance
healing of the elongate tissue. For example, as the biodegredable
polymers and/or natural materials may include elements to promote
tissue growth and/or healing that may be released as the
biodegradeable polymers and/or natural materials are broken down by
the body.
[0067] Portions (or all) of the coil member 103 may be porous. The
porosity of the coil member 103 may promote tissue growth and/or
cellular in-growth, which may enhance engagement or securement of
the tissue repair device 100 relative to the injured tissue and/or
surrounding tissue. Porosity of the coil member may also contribute
to coil compliance and degradation rate. As will be described
below, coating may be employed to enhance or reduce porosity of the
coil member 103.
[0068] FIG. 2 shows a tissue repair device 200 encircling an
injured portion 201 of an elongate tissue 202. The tissue repair
device 200 may employ principles of friction and constriction to
maintain engagement with and secure the injured portion 201 of the
elongate tissue 202 in place, and to limit slipping of the device
200 along the tissue 202. The tissue repair device 200 may employ
principles of friction and/or constriction to remain fixed in place
relative to the elongate tissue 202. For example, sutures may not
be needed to maintain the device 200 in a fixed position relative
to the elongate tissue 200.
[0069] FIG. 3 shows a tissue repair device 300, according to one
embodiment. The tissue repair device 300 is shown encapsulating
injured tissue 304. The tension of the tissue repair device 300
during extension is equally distributed circumferentially 305
around the device, resulting in constriction of the tissue repair
device 300 to engage or grip the elongate tissue. This
circumferential tension distribution reduces the risk of tearing
tissue that is in contact with the device 300, particularly
compared to sutures having tension highly concentrated at a single
site of insertion. The tension in the device 300 (and corresponding
constriction of the device 300) may be less toward the outside ends
303 and greater at the center 301 of the device 300. The increased
tension at the center of the device 301 alleviates the tension
experienced by the injured tissue 304 at its center 302, reducing
the risk of tissue separation and/or tearing of sutures at the
injured site. The illustrated tissue repair device 300 may be used
in conjunction or in lieu of sutures to connect together injured
tissue, such as free (or separated) ends of torn (or partially
torn) elongate tissue.
[0070] FIG. 4 shows a tissue repair device 401 enclosing or
encircling frayed ends 402 of an elongate tissue 400
circumferentially. The illustrated tissue repair device 401 can
gather frayed ends 402 by encapsulation, removing a need for
complex suturing to gather the frayed ends. The frayed ends 402 are
gathered within a lumen of the tissue repair device. The tissue
repair device 401 may maintain the frayed ends 402 in close
proximity to one another to facilitate and enhance healing of the
elongate tissue 400.
[0071] FIG. 5 shows a tissue repair device 500, according to
another embodiment. The illustrated tissue repair device 500 may
have a larger coil diameter W.sub.1 on a first end 501 of the
device 500 that can be varied by A and a smaller diameter W.sub.2
at a second opposing end 502 that can be varied by B. This design
may accommodate changes in a diameter of the tissue along its
length X.
[0072] FIG. 6 shows a tissue repair device 600, according to
another embodiment. The illustrated tissue repair device 600 may
have a smaller coil diameter W.sub.1 towards a center portion 603
that can be varied by X and a larger coil diameter W.sub.2 that can
be varied by Y at a first end 601 and the same or different larger
coil diameter W.sub.3 that can be varied by Z at an opposing second
end 602.
[0073] FIG. 7 shows a tissue repair device 700, according to
another embodiment. The illustrated tissue repair device may have a
larger coil diameter W.sub.1 that can be varied by X at a center
portion 703 of the device 700 and a smaller coil diameter W.sub.2
that can be varied by Y at a first end 701 and the same or
different smaller coil diameter W.sub.3 that can be varied by Z at
the opposing second end 702.
[0074] FIG. 8 shows various shaped cross sectional areas 800-810 of
a coil member (see coil member 103 of FIG. 1) of a tissue repair
device. Varying cross sectional shapes can be used to maintain the
tissue repair device in contact with the tissue and to enable the
proper movement of the device within the body. The dimensions of
the cross sectional areas 800-810 can be altered to best suit the
implant situation. The various examples illustrated are merely
representative, and are not in any way limiting of the scope of the
present disclosure.
[0075] FIG. 9 shows transverse cross sectional areas 900-910 of
various tissue repair device, illustrating that varying shaped
lumen may be defined by the tissue repair device and can be used to
maintain the tissue repair device in contact with the tissue and to
enable the proper movement of the device within the body. The
dimensions of the cross sectional areas 900-910 can be altered to
best suit the implant situation. The various examples illustrated
are merely representative, and are not in any way limiting of the
scope of the present disclosure.
[0076] FIG. 10A-D shows example magnified cross sectional views of
a coil member 1000, according to various embodiments, to illustrate
that the coil member 1000 can be textured on all surfaces 1001, as
shown in FIG. 10A. The texture may provide one of nano-, micro-,
meso- and macro-textured surfaces on the coil member 1000. The coil
member 1000 can have texture only along a top surface 1002 or outer
surface 1002, as shown in FIG. 10B, thereby effect (e.g., engaging)
the surrounding tissue and environment. The coil member 1000 can
have texture only along the bottom surface 1003, or inner surface
1003, as seen in FIG. 10C, thereby effect (e.g., engaging) the
elongate tissue to be repaired. FIG. 10D shows different texture
along the top or outer surface 1004 and the bottom or inner surface
1005 of the coil member 1000. Textured surfaces can increase
surface area, which may enable increased friction and thereby limit
slipping of a device of along tissue to be repaired and/or along
surrounding tissue. The surface texture may also increase or
decrease tissue adhesion as appropriate. Surface texture can be
used as appropriate to enhance, or even optimize functionality and
ability to repair or support injured tissue. The coil member 1000
may also be smooth, or substantially free of surface texture, on
all surfaces.
[0077] FIG. 11A shows a cross sectional area of the coil member
1100 illustrating the coil member 1000 can include a coating 1101
on all sides 1102. FIG. 11B shows the coil member 1100 with a
coating 1102 only along the top or outer surface that affects the
outside of the device or tissue surrounding the device. FIG. 11C
shows the coil member 1100 with a coating 1103 only along a bottom
or inner surface that affects the inside of the device adjacent to
the tissue to be repaired. FIG. 11D shows the coil member 1100 with
a coating 1105 along the top our outer surface 1105 and a different
coating 1104 along the bottom or inner surface. The foregoing
described coatings can comprise altered surface chemistry, chemical
coatings, mineral coatings, biological coatings such as proteins,
cells, sugars, lipids, etc., and cells such as stem cells,
fibroblasts, chondrocytes, epithelial cells, endothelial cells,
smooth muscle cells, macrophages, etc. These coatings can assist in
cell adhesion, tissue regeneration, and preventing cell adhesion
and tissue growth. Coatings can be used to optimize this device's
functionality and ability to repair or support injured tissue.
[0078] In one embodiment, the coatings described above may be
porous. A porous surface of the coiled member may promote cellular
in-growth, which may further stabilize and ensure fixation of the
tissue repair device relative to surrounding tissue. In another
embodiment, the coiled member 1100 itself may be porous and the
coating may reduce porosity where cellular in-growth may not be
desired.
[0079] FIG. 12A shows a tissue repair device 1200, according to one
embodiment. The tissue repair device 1200 is disposed around and
engaging an elongate tissue 1202. In FIG. 12A, injured tissue 1203
is shown pressing up (or out) between the turns 1206 of the device
1200. If a diameter of the device 1200 is smaller than a diameter
of the elongate tissue 1202, then portions of the injured tissue
1203 may press up (or out) between each turn 1206 of the device
1200. The buckling or pressing up (or out) of the portions of the
tissue 1203 between each turn 1206 of the tissue repair device 1200
may create multiple catch points that may prevent the tissue 1202
and device 1200 from sliding relative to each other and/or past one
another.
[0080] FIG. 12B shows the buckling or pressing up of tissue 1203
between each turn 1206 of the device 1200 during extension of the
tissue repair device 1200 and elongate tissue 1202. In the case of
ligaments or tendons that do not have vasculature, this
construction and buckling may not limit or prevent diffusion of
nutrients in the tissue. Also only slight buckling may be
sufficient that may not greatly reduce the overall length of the
tissue. If the tissue to be repaired is a vessel, such as a blood
vessel with a hollow lumen, then the diameter of the device can be
adjusted so that no buckling of the tissue will occur and the
device may be used as a support.
[0081] FIG. 13A Shows a method of deploying a device 1300 onto
tissue 1302 that is partially or fully torn. An end 1306 of the
coil member 1303 of the coil device 1300 can be placed on the
tissue where there is an open end of the coil 1300. The device 1300
can be twisted in the direction shown by the arrows 1301 onto the
tissue much like a key ring onto a key, twisting the device 1300,
for example one turn 1304 at a time. FIG. 13B shows the device 1300
in place on the injured tissue 1302. An aspect of the disclosed
embodiments, is that due to the coiled design, the embodiments can
be placed onto tissues that are not completely lacerated, but can
be twisted onto partially intact tissue. FIG. 13C shows healed
tissue 1305, after the device 1300 dissolves or is removed.
[0082] As described above, a coil member 1303 of the tissue repair
device 1300 may be formed of a biodegradable polymers and/or
natural materials that can be broken down by the body after the
injured tissue is sufficiently healed, allowing the native tissue
to return to its normal state. The coil member 1303 can be infused
with, or otherwise include nutrients, supplements, medicaments,
sugars, growth factors, proteins, and/or hormones, which may
promote and enhance healing of the elongate tissue. For example, as
the biodegredable polymers and/or natural materials may include
elements to promote tissue growth and/or healing that may be
released as the biodegradeable polymers and/or natural materials
are broken down by the body. Eventually the entire coil member 1303
may break down and/or be absorbed by the body, as shown in FIG.
13C.
[0083] FIG. 14A shows a method where a device 1400 can be twisted
in the reverse direction of the coil member 1403 on either end in
order to increase the diameter of the turns of the coil member
1403, enabling a larger space (lumen 1405) to insert the target
injured elongate tissue 1402 to be repaired. FIG. 14A illustrate
first and second free ends of torn elongate tissue 1402 being
inserted into the lumen 1405 of the device 1400 such that the coil
member 1403 can constrict around the free ends and draw and or
maintain them together in close proximity. FIG. 14B shows the
device 1400 in place on injured tissue 1402. The coil member 1403,
and therefore the lumen 1405, of the device 1400 is constricted
toward the relaxed state in engagement gripping the elongate tissue
1402. FIG. 14C shows healed tissue 1404 after the device 1400
dissolves or is removed.
[0084] FIGS. 15A and 15B show a method of threading sutures
connected to tissue through a device 1500. FIG. 15A shows a pair of
sutures 1504 that are sutured to each severed end of injured tissue
1502. The sutures 1504 can be threaded into and/or through a lumen
1505 of a tissue repair device 1500. FIG. 15B shows a method of
threading the available end (or free end) of the sutures 1504 into
and through a lumen the device 1500 and pulling the sutures 1504
through the device in order to pull the attached severed tissue
1502 into the device 1500. FIG. 15C shows severed tissue 1502
within and encircled by the device 1500.
[0085] FIG. 16 is a flow diagram of a manufacturing process for
producing a device, according to one embodiment, by using an
injection molding system. First a polymer (or other material of
manufacture, e.g., metal) may be dissolved or melted 1600. Next the
polymer is injected into a mold 1601. Next the polymer can be
modified using physical or chemical processes 1602. Next the
polymer is allowed to set 1603. Next the polymer can be removed
from the mold and further modified using physical or chemical
processes 1604. Next quality assurance testing can be performed on
the device 1605. Lastly, sterilization and packaging may be
performed 1606.
[0086] FIG. 17 is a flow diagram of a manufacturing process for
producing a device, according to one embodiment of the present
disclosure, by wrapping an extruded polymer around a heated dowel
or heating the polymer and wrapping it around a heated or
non-heated dowel. First the polymer is prepared 1700 by being
dissolved, melted, etc. Next the polymer is extruded 1701. Next the
polymer is wrapped around a heated dowel 1702. Alternatively the
polymer can be heated and wrapped around a heated or non-heated
dowel 1702. Next the polymer is allowed to set and may be modified
using physical or chemical processes 1703. The polymer may be
removed from the dowel 1704. The polymer may be further modified
using physical or chemical processes 1705. Quality assurance
testing may be performed on the device 1706. Sterilization and
packaging may be performed 1707.
[0087] FIG. 18 is a flow diagram of a manufacturing process for
producing a device, according to the present disclosure, by
wrapping metal around a heated dowel or heating the metal and
wrapping it around a heated or non-heated dowel. First the metal is
prepared 1800. Next the metal is wrapped around a heated dowel
1801. Alternatively the metal can be heated and wrapped around a
heated or non-heated dowel 1801. Next the metal is allowed to set
and can be subsequently modified using physical or chemical
processes 1802. Next the metal can be removed from the dowel and
further modified using physical or chemical processes 1803. Next
quality assurance testing can be performed on the device 1804.
Lastly, sterilization and packaging may be performed 1805.
[0088] Additional embodiments include any suitable combination of
the features depicted in the drawings. Accordingly, although a
specific permutation may not be illustrated as a stand-alone
embodiment in any of the drawings, all of the features are shown
and described in the drawings such that the present drawings
provide full support for these additional embodiments.
[0089] The disclosed embodiments may comprise a device with a
center shape that can accommodate the shape of the tissue to be
ligated or supported. These shapes include but are not limited to:
circle, elliptical, square, rectangle, triangle trapezoid, or any
combination of these shapes that may change shape along the length
of the device. For example one end can begin as a circle cross
section, but end as an ellipsoid cross section.
[0090] The disclosed embodiments may use the number and tightness
of coils to control the grip onto the tissue
[0091] The disclosed embodiments may use principles of friction and
constriction to maintain contact with tissue.
[0092] The disclosed embodiments may comprise a coil member used to
make a coil that can have various shaped cross-sectional areas
including circle, elliptical, square, rectangle, triangle
trapezoid, etc., or any combination of these shapes and where these
shapes can change along the length of the coil member.
[0093] The disclosed embodiments may comprise a coil member that
can be made of varying thicknesses of material that can vary along
the length of the device.
[0094] The disclosed embodiments where the device comprises an
elongate hollow coiled member of biocompatible, surgically
implantable material. The member having a first and second end,
with the device being open at both ends.
[0095] The disclosed embodiments may comprise a method for treating
weakened, damaged, and partially or completely lacerated tissue,
wherein this method comprises obtaining a tissue repair device and
accessing injured tissue within the body.
[0096] One of the disclosed embodiments may be a method of
manufacturing a tissue repair device, comprising: preparing a
biocompatible material; forming the biocompatible material into a
coil comprising a series of interconnected turns defining a lumen
through the coil, the lumen being open at both ends and configured
to receive and encircle an elongate tissue to be repaired, wherein
the material in a hardened state is configured to allow the coil to
be extendable to increase a distance between adjacent turns of the
plurality of turns and increase a length of the coil and to
decrease a diameter of one or more of the turns of the plurality of
turns proportional to extension of the length to more tightly
engage an elongate tissue disposed within the lumen to decrease
tension at a wound site of the elongate tissue by distributing
tension along a length of the coil; and allowing the biocompatible
material to set.
[0097] The method of manufacture may further include texturing an
inner surface of the coil to enhance engagement of the inner
surface with tissue to be repaired and limit sliding of the tissue
repair device relative to the tissue to be repaired.
[0098] The examples and embodiments disclosed herein are to be
construed as merely illustrative and exemplary, and not a
limitation of the scope of the present disclosure in any way. It
will be understood to those having skill in the art that changes
may be made to the details of the above-described embodiments
without departing from the underlying principles of the disclosure
herein. For example, any suitable combination of various
embodiments, or the features thereof, is contemplated. For example,
any of the devices disclosed herein can include features of other
embodiments. The scope of the invention is therefore defined by the
following claims and their equivalents.
* * * * *