U.S. patent application number 13/410522 was filed with the patent office on 2012-09-06 for method of using an implant for treatment of ligaments and tendons.
This patent application is currently assigned to SPINEOVATIONS, INC.. Invention is credited to Neville Alleyne, Stuart Young.
Application Number | 20120226354 13/410522 |
Document ID | / |
Family ID | 35429609 |
Filed Date | 2012-09-06 |
United States Patent
Application |
20120226354 |
Kind Code |
A1 |
Alleyne; Neville ; et
al. |
September 6, 2012 |
METHOD OF USING AN IMPLANT FOR TREATMENT OF LIGAMENTS AND
TENDONS
Abstract
A method of treating a ligament or tendon according to the
present invention can include inserting a tissue-generating implant
into the ligament or tendon to thereby treat the defect. The
tissue-generating implant has a plurality of microparticles. The
microparticles subsequently form a biological scaffold which
operates at least as partial connective tissue in the ligament or
tendon giving structural support during regrowth.
Inventors: |
Alleyne; Neville; (La Jolla,
CA) ; Young; Stuart; (Del Mar, CA) |
Assignee: |
SPINEOVATIONS, INC.
San Diego
CA
|
Family ID: |
35429609 |
Appl. No.: |
13/410522 |
Filed: |
March 2, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11215300 |
Aug 30, 2005 |
8127770 |
|
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13410522 |
|
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60605582 |
Aug 30, 2004 |
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Current U.S.
Class: |
623/13.11 |
Current CPC
Class: |
A61F 2/0805 20130101;
A61F 2210/0004 20130101; A61L 27/48 20130101; A61F 2/08 20130101;
A61L 27/24 20130101 |
Class at
Publication: |
623/13.11 |
International
Class: |
A61F 2/08 20060101
A61F002/08 |
Claims
1. A method of treating a ligament or tendon comprising delivering
an injectable composition comprising a plurality of inert
histocompatible microparticles suspended in a solution containing
collagen onto or into the ligament or tendon.
2. The method of claim 1, additionally comprising identifying a
defect in the ligament or tendon.
3. The method of claim 1, wherein the composition forms a
biological scaffold comprising at least a portion of the
microparticles, and wherein the biological scaffold operates at
least as partial connective tissue in the ligament or tendon.
4. The method of claim 1, wherein the composition is configured to
be partially replaced with host tissue.
5. (canceled)
6. The method of claim 1, wherein the composition comprises at
least one of water, saline, a tenside, radiopaque dye, and a
chromophobe.
7. (canceled)
8. The method of claim 1, wherein the microparticles are
substantially spherical with diameters in the range of about 15 to
about 200 microns.
9. The method of claim 1, wherein the microparticles comprise one
or more of poly methacrylate, polymethylmethacrylate (PMMA), a
cured polymer, a fully polymerized polymer, and glass.
10. The method of claim 1, wherein the ligament or tendon comprises
at least one of an anterior longitudinal ligament, a posterior
longitudinal ligament, a supraspinous ligament, an intraspinous
ligament, a capsular ligament, an anterior cruciate ligament (ACL),
a posterior cruciate ligament (PCL), and a rotator cuff.
11. The method of claim 2, wherein a location of the defect is at
least one of a musculotendinous junction, a tendinous region, and
an insertion of a tendon insertion.
12. The method of claim 1, further comprising delivering the
composition to an anastomosis site.
13. The method of claim 1, further comprising performing tissue
treatments on or within the ligament or tendon or adjacent tissue
to facilitate tissue reactions.
14. The method of claim 2, wherein: identifying the defect
comprises identifying a defect in a patient having congenital,
idiopathic, or acquired scoliosis or kyphosis; and delivering the
composition comprises delivering the composition to the ligament or
tendon in a region of the patient exhibiting abnormal
curvature.
15. The method of claim 14, further comprising retarding
progression of the curvature or partially correcting the
curvature.
16. The method of claim 1, wherein the composition comprises a
chromophobe, the method further comprising activating the
chromophobe with a laser to accelerate a reaction in or near the
ligament or tendon.
17. The method of claim 1, wherein the composition comprises a
radiopaque material, the method further comprising visualizing the
composition by means of the radiopaque material.
18. The method of claim 17, wherein the radiopaque material
comprises barium.
19. (canceled)
20. (canceled)
21. A medical kit comprising: an injectable composition comprising
a plurality of inert histocompatible microparticles suspended in a
solution containing collagen; and one or more surgical tools
configured for repairing at least one tendon or ligament.
22. The medical kit of claim 21, further comprising a delivery
device configured to deliver the composition.
23.-29. (canceled)
30. The kit of claim 21, wherein the microparticles are
substantially spherical, and wherein the microparticles have a
diameter of about 15 microns to about 200 microns.
31. The kit of claim 21, wherein the composition comprises at least
one of water, saline, a tenside, radiopaque dye, and a
chromophobe.
32. The kit of claim 21, wherein the microparticles comprise one or
more of poly methacrylate, polymethylmethacrylate (PMMA), a cured
polymer, a fully polymerized polymer, and glass.
33. The kit of claim 21, wherein the composition comprises a
chromophobe for activation with a laser to accelerate a reaction in
or near the ligament or tendon.
34. The kit of claim 21, wherein the composition comprises a
radiopaque material for visualizing the composition by means of the
radiopaque material.
35. The kit of claim 34, wherein the radiopaque material comprises
barium.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/215,300, filed Aug. 30, 2005, which claims
priority under 35 U.S.C. Section 119(e) to U.S. Provisional
Application No. 60/605,582 filed on Aug. 30, 2004. The disclosures
of the above-referenced prior applications, publications, and
patents are considered part of the disclosure of this application,
and are incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to surgical implants
and, more particularly, relates to surgical implants and procedures
for repairing ligaments and tendons.
[0004] 2. Description of the Related Art
[0005] Ligaments and tendons provide support and stability to the
musculoskeletal system. Generally consisting of bands or sheets of
fibrous connective tissue, ligaments and tendons when damaged can
be painful and often times debilitating. Treatments of these
connective tissues can comprise repair by means such as suturing,
or can comprise complete or partial replacement with other
biological or synthetic materials. As a result of the complexity
and functionality of these tissues and general repair
considerations, it is generally preferred that the treatment retain
and return these tissues to their pre-damaged conditions.
[0006] Regarding the repair of ligaments and tendons, as
distinguished from replacement, one of the more common ligament
repair procedures involves reconstruction of the anterior cruciate
ligament (ACL). Several hundred thousand ACL repairs and
reconstructions are performed every year in the United States. That
number continues to grow as the population continues to become more
active in recreational sports and competitive sports such as
soccer, football, basketball, track and field. A segment of the
population comprises individuals who will end up sustaining partial
injuries to their ACL or posterior cruciate ligaments (PCL),
requiring surgery to assist in the healing. It has been known for
some time that ACL deficient knees and PCL deficient knees can
subsequently lead to other intraarticular pathologies, such as
meniscal tears or collateral ligament attenuations. Consequently,
as with injuries to other ligaments and tendons, the pursuit of
effective interventions for efficiently treating injured ligaments
and tendons continues to be an active and needed field of active
endeavor.
SUMMARY OF THE INVENTION
[0007] The present invention introduces implants into ligaments and
tendons for repairing or otherwise treating the ligaments or
tendons.
[0008] In one embodiment, a method of treating a ligament or tendon
comprises delivering an implant comprising a plurality of
microparticles onto or into the ligament or tendon.
[0009] In another embodiment, a medical kit comprises an implant
comprising microparticles, and one or more surgical tools
configured for repairing at least one tendon or ligament.
[0010] In another embodiment, an implant comprising a plurality of
microparticles, for use in repairing damaged ligaments or
tendons.
[0011] In another embodiment, a method of treating a tendon or
ligament comprising placing a plurality of particles into contact
with at least a portion of the ligament or tendon.
[0012] In each of these embodiments, the particles may be suspended
in a medium comprising collagen.
DETAILED DESCRIPTION OF THE INVENTION
[0013] Any feature or combination of features described herein are
included within the scope of the present invention provided that
the features included in any such combination are not mutually
inconsistent as will be apparent from the context, this
description, and the knowledge of one skilled in the art. In
addition, any feature or combination of features may be
specifically excluded from any embodiment of the present invention.
For purposes of summarizing the present invention, certain aspects,
advantages and novel features of the present invention are
described herein. Of course, it is to be understood that not
necessarily all such aspects, advantages or features will be
embodied in any particular embodiment of the present invention.
[0014] In reference to the disclosure herein, for purposes of
convenience and clarity only, directional terms, such as top,
bottom, left, right, up, down, upper, lower, over, above, below,
beneath, rear, and front, may be used. Such directional terms
should not be construed to limit the scope of the invention in any
manner. It is to be understood that embodiments presented herein
are by way of example and not by way of limitation. The intent of
the following detailed description, although discussing exemplary
embodiments, is to be construed to cover all modifications,
alternatives, and equivalents of the embodiments as may fall within
the spirit and scope of the invention.
[0015] The present invention provides compositions and methods for
selectively treating defects or other conditions within or on
ligaments and tendons. These procedures of the present invention
primarily relate to ligament and tendon surgeries, such as
procedures on flexor or extensor tendons in for example the hand or
antebrachium or brachium as well as shoulder, including but not
limited to rotator cuff (supraspinatus, infraspinatus, teres minor
and subscapularis) but also including biceps tendon, intraarticular
and extraarticular, as well as the carpal ligaments in the wrist
and at the distal radial ulnar joint and proximal radial ulnar
joint. Also included are procedures on ligaments or tendons in and
around the pelvis including the sacroiliac joint as well as the
insertion at the anterior superior iliac spine of the sartorius,
tensor fascia lata or at the anterior inferior iliac spine for the
insertion of the rectus, or disruption of the symphysis pubis or at
the ischium or the insertion of the biceps femoris and
semitendinosus, semimembranosus or the adductor magnus. Moving
distally, ligament and tendon repair or augmentation procedures
around the hip can include procedures on attachments to the greater
trochanter (piriformis, gluteus minimus, gluteus medius, gluteus
maximus, obturator intemus and the superior and inferior gemelli as
well as the obturator extemus). As for the lesser trochanter,
procedures can be implemented on attachments including psoas major
and adductor magnus iliacus. Moving more distally to the distal end
of the femur on the medial epicondyle and supracondylar region,
procedures can be implemented on attachments including the
attachment of the gastroc and the tendon of the adductor magnus. On
the lateral condyle, procedures can be implemented on attachments
including the plantaris, lateral head of the gastrocnemius
popliteus as well as the quadriceps muscle including rectus, vastus
medialis, vastus intermedius, vastus lateralis and the insertions
of the common tendon, as well as the continuation of that tendon
into the patellar tendon, the anterior and posterior and lateral
muscles of the leg and their tendinous insertions, and the
ligaments and tendons of the ankle and foot ranging in size from
small to relatively large (e.g., Archilles tendon).
[0016] Particular implementations, according to certain aspects of
the present invention, can include repair in connection with the
major ligament reconstructions that are being performed on a daily
basis in orthopedics/sports medicine disciplines, including
treatments of the anterior crociate ligament (ACL), the posterior
cruciate ligament (PCL), the medial and lateral collateral
ligaments, the medial and lateral meniscus, the rotator cuff and
biceps tendon musculature, as well as smaller ligaments such as the
medial and lateral collateral ligaments of the elbow, the
triangular fibrocartilage complex (TFCC) and other ligaments of the
wrist and distal radial ulnar joint, as well as the ankle ligaments
including but not limited to the anterior talofibular,
calcaneofibular ligament, posterior talofibular ligament, and
deltoid ligament.
[0017] Included within the scope of the present invention are the
additional ligaments that support the spine and the motion
segments. The methods of the present invention can thus be applied
to, for example, ligaments including the anterior longitudinal
ligament, posterior longitudinal ligament, facet joint capsules and
capsular ligaments, supraspinous ligament, and intraspinous
ligament, which may give rise to additional structural stability to
the spine and motion segments that may be involved in conjunction
with disk degeneration, pars defects, anterior listhesis or
retrolisthesis or laterallisthesis or rotatory scoliosis.
[0018] The aforementioned group of applications, including
treatments of ligaments related to the joints of the upper and
lower limbs, as well as the pelvis, is only a partial list. In one
or more of the above contexts, application of a tissue-generating
or collagen-promoting implant according to the present invention
can provide structural support in the healing of ligaments and
tendons, whether the defect, injury or area of interest is at (i)
any location of the ligament or adjacent tissues including the
origin and insertion thereof, or (ii) any location of the tendon or
adjacent tissues such as the musculotendinous junction or anywhere
in the tendinous region or at the insertion of the tendon
insertion. The scope and field of the present invention for
orthopedic tendons and ligament reconstruction, however, is vast
and is intended to include any of the major or minor joints with
ligaments or tendons that may be injured or otherwise determined to
be in need of or likely to benefit from an intervention or
treatment using tissue-generating implants.
[0019] In accordance with a feature of the present invention,
methods are provided for treating ligaments and tendons such as,
for example, those set forth above. Tissue-generating implants can
be introduced onto and/or into one or more tissues of interest in
connection with repairs or treatments of ligaments and tendons in
relation to or within an organism. The tissue-generating implants
can include particles, such as tissue-growth-inducing particles,
such as microparticles which have smooth surfaces that are
substantially free from corners and edges and which, for example,
are suspended in a biocompatible medium.
[0020] The tissue-generating implant can be inserted (e.g.,
injected) into a ligament or tendon, such as a partial or complete
ligament or tendon defect, to thereby facilitate or augment a
repair of the ligament or tendon defect. A partial ligament or
tendon defect may comprise a ligament or tendon which is not
entirely severed. A complete ligament or tendon defect may include
for example a ligament which has been completely severed or
detached and which, by means known to those skilled in the art,
such as, for example, anastomosis using sutures, has been or will
be reattached or mended.
[0021] Implementations of the present invention can include
treatment of patients with, for example, congenital, idiopathic, or
acquired scoliosis or kyphosis, by the addition of
tissue-generating implants to the region in question which shows
the abnormal curvature. The provision of additional structural
support to one particular side of a motion segment can favor the
mechanics in that region and can provide a means for retarding
progression of the curvature or possibly even correcting the
curvature.
[0022] Generally, in one or more of any of the above applications,
the addition of the tissue-generating implant may allow increased
structural support and integrity to the repair site (e.g., the
motion segment), so as, in the example of spinal applications for
example, to attenuate or minimize abnormal movement and/or increase
the inherent stability of the spine. Accordingly, representative
applications of the tissue-generating implant can include providing
structural support to ligaments or tendons that are partially or
completely severed, or can include augmenting the repairs. For
instance, the tissue-generating implant can provide a biological
scaffold helping to support fixation for repair or augmentation of
the ligament or tendon in question, and can also operate as a
partial permanent connective tissue scaffold in the ligament or
tendon repair.
[0023] As but one exemplary area of application of the present
invention, the tissue-generating implant can be inserted into
either the ACL or PCL requiring surgery to thereby assist in the
healing. The tissue-generating implant can be used, for example, to
strengthen the collateral ligaments in the event that they are torn
with a grade 1 or grade 2 tear to thereby potentiate or accelerate
the healing, and in some instances obviate the need for, or reduce
a necessity or extent of, surgical intervention.
[0024] Treatment of ligaments or tendons by insertion of the
tissue-generating implants in accordance with the present invention
can serve, ultimately, to augment those ligaments or tendons with
additional host tissue. The additional host tissue is not implanted
but, rather, is generated naturally by the host at the site of the
insertion, and integrated into existing tissues by the host at the
site of insertion. This natural introduction of host tissue onto or
into the ligament or tendon can increase the healing strength of
these tissues.
[0025] The tissue-generating implant typically is carried (e.g.,
suspended) in a biocompatible medium, and the treatment typically
comprises injection of the tissue-generating implant into a partial
or complete ligament or tendon defect or area of interest.
[0026] Following insertion (e.g., injection) of the
tissue-generating implant into an area or areas of interest of a
ligament or tendon, such as an ACL, PCL or one of the medial and
collateral ligaments, the tissue-generating implant in accordance
with one aspect of the present invention begins to undergo a
complete or at least partial biodegradation of the biocompatible
medium. In a representative embodiment, the biocompatible medium
comprises bovine collagen which, following insertion of the
tissue-generating implant, begins to be (i) resorbed into or via
tissues of the host mammalian body and/or (ii) replaced or
supplemented with host tissue (e.g., collagen). In a representative
embodiment, the biocompatible medium is both resorbed and replaced
with host tissues. Optionally, in any of the above-stated
applications, such as injection of the tissue-generating implant
into the collateral ligaments, ligaments, tendons or adjacent
tissues, such as the adjacent articular cartilage, can be
perforated as outlined below or otherwise treated to enhance a
supply of fluid (e.g. blood) to the area of treatment or repair.
The additional availability of fluid, in turn, can assist in
resorption of the biocompatible medium and/or the replacement or
supplementation thereof with host tissue.
[0027] In a representative embodiment comprising insertion into a
ligament or tendon of a tissue-generating implant comprising
microparticles which have smooth surfaces free from corners and
edges and which are suspended in a biocompatible medium, the
microparticles induce formation of host tissue (e.g., collagen) at
or near the region of insertion. In one example, the microparticles
comprise polymethylmethacrylate (PMMA) microspheres, and host
collagen is formed around these PMMA microspheres maintaining their
position. The addition of this host collagen then gives rise to
structural support and stability to, for example, the ACL or PCL
deficient knee or ACL/PCL partially deficient knee. Certainly in
acute injuries in which the ACL or PCL is being repaired, the
addition of the present tissue-generating implant can give rise to
increased stability and success for the repair. The smaller
ligaments in the carpus and the distal radial ulnar joint and the
larger ligaments such as the ACL and PCL are amenable to treatment
using the tissue-generating implant methods of the present
invention, as well.
[0028] In the contexts of ligaments and tendons, the
tissue-generating implant can be inserted, for example, injected
via a syringe needle, to a partial or complete ligament or tendon
defect or area of interest and extended along a length of an
insertion-device (e.g., needle) path as, for example, the insertion
device is withdrawn. For instance, as discussed below, the
tissue-generating implant can be injected via a syringe needle to
an anastomosis site and extended up to the origin and insertion
point of the ligament in question. Tissue treatments, such as
microperforations, also discussed below, can be formed the same
way, with a needle or awl to insure increased blood flow to the
surrounding tissue.
[0029] Insertions (e.g., injections) of the tissue-generating
implant may be formed in directions parallel to lengths of the
ligaments or tendons, along directions perpendicular to lengths of
the ligaments or tendons, and/or in any other directions or
combinations of directions. The directions and/or lengths of the
injections may vary along similar or different paths or axes, and
the amounts of tissue-generating implant may vary per unit length
along individual injection paths and/or among different injection
paths. Such variances of amounts of tissue-generating implant may
differ per unit length along individual injections and/or between
various injections as a result of varying types of
tissue-generating implants and/or biocompatible mediums being used,
varying injection rates, varying withdrawal rates, varying diameter
injection devices, and other relative variances in injection
techniques and materials.
[0030] Tissue treatments, such as perforations or, in a
representative embodiment, microperforations, may be formed on or
within ligaments or tendons to be treated, and/or onto or within
adjacent tissues, to facilitate tissue reactions such as, for
example, an increase of fluid (e.g., blood) flow to one or more
areas of interest. The treatments (e.g., perforations) may be
formed in point, straight or curved segments along any direction,
orientation, axis or axes with respect to the ligament, tendon
and/or adjacent tissue. Perforations may be formed, for example,
with a needle or awl in the ligament, tendon and/or adjacent
tissue, thus forming, for example, short or elongate fluid-flow
paths. In examples involving ligament or tendon anastomosis
procedures, proximal and/or distal ends of the ligaments or tendons
can be perforated, as described below. The perforations can be
formed at the anastomosis site to extend up to the origin and
insertion point of the ligament in question. Generally, the tissue
treatments (e.g., perforations) as described herein may be formed
in directions parallel to lengths of the ligaments or tendons,
along directions perpendicular to lengths of the ligaments or
tendons, and/or along any directions or combinations of directions
therebetween. The directions and/or lengths of the perforations may
vary along similar or different paths or axes, and the
cross-sectional areas or diameters of the perforations may vary per
unit length along individual perforations and/or between
perforations, as a result of, for example, varying types, sizes and
shapes of perforating instruments being used and varying
perforating techniques.
[0031] When the tissue-generating implant is inserted according to
the present invention into ligaments, such as the smaller
ligaments, tissue treatments (e.g., microperforations made with a
needle or awl) can be introduced at the origins and insertions of
the ligaments to increase blood flow to the surrounding tissues. In
addition, or alternatively, when the tissue-generating implant is
placed, for example, around and/or near a ligament (especially onto
or around an area of injury or damage to the ligament or tendon),
tissue treatments (e.g., microperforations) can be introduced at
the origin and insertion of the ligament reconstruction to afford
increased blood flow to the tissue-generating implant, thus
assuring the resorption of the biocompatible medium (e.g., bovine
collagen) and replacement with host tissue (e.g., collagen), and
increasing a structural support given to the ligament or ligaments
in question. With tendons, either percutaneous or open repair can
be utilized with the tissue-generating implant at the time of the
surgery to augment its structural integrity. As for tendons, blood
flow from the musculotendinous junction and tissue treatments
(e.g., perforations) at the distal insertion can be sufficient to
allow or enhance blood flow to result in suitable biocompatible
medium (e.g., bovine collagen) resorption and replacement with host
tissue (e.g., human collagen), thereby providing structural support
to the tendons as well. In an exemplary embodiment implementing
perforations placed at the origin insertion of the ligament or at
the insertion of the tendon, the perforations may need only be
microperforations to increase the blood flow to that region to
ensure that this resorption occurs over an appropriate period of
time.
[0032] In some implementations the tissue-generating implant can be
impregnated with a chromophobe, which can be activated from outside
the body with a laser to accelerate a biological reaction within
the ligament or tendon.
[0033] In accordance with one aspect of the present invention, the
tissue-generating implant can be applied to an anastomosis site of
a ligament or a tendon in, for example, an open procedure. The
tissue-generating implant can be applied in or to at least one of
the ligament or tendon (e.g. ligament or tendon ends) at any time
prior to, during and/or after the anastomosis. In a representative
embodiment, the tissue-generating implant is injected into the
ligament or tendon ends prior to anatomical approximation and
attachment of the ends together. For example, in a tendon
anastomosis procedure, two severed tendon ends can be anatomically
approximated while endeavoring to minimize tension and forcep
manipulation which can cause scarring. The tissue-generating
implant can be injected via a syringe needle to the anastomosis
site and extended up to the origin and insertion point(s) of the
tendon(s) in question. Optional microperforations as discussed
below can be introduced, for example, in the same or a similar way
with a needle or awl to increase blood flow to the surrounding
tissue. The tendon ends can now be sewn together, using. for
example, 4-0 Mersilene sutures according to well known surgical
manners. Modified Bunnell sutures can be used, wherein the knots
are securely tied to avoid tendon end gapping after approximating
forces are removed. A running 6-0 nylon peritenon suture can be
used, for example, on the anterior half of the tendon repair. The
posterior half of the tendon repair can then be made accessible for
examining the anatomical accuracy of the repair and/or completing
the tendon running suture.
[0034] At some point or points prior to, during, or following any
treatment (e.g., anastomosis) described herein, at least one
exposed surface (e.g., one or more of a proximal end and a distal
end of the ligament or tendon) can be perforated or otherwise
treated to, for example, increase blood flow to one or more
adjacent or surrounding tissues. For example, microperforations can
be formed using a needle or awl in the proximal and distal ligament
or tendon ends to facilitate increased blood flow to surrounding
tissues. In one implementation, microperforations introduced to the
anastomosis site extend up to the origin and insertion point of the
ligament or tendon in question. As for tendon repair. it is readily
envisioned by those skilled in the art that tendons go through
early or late rupture. During the early phase, rapid loading or
stretching of the tendons may lead to failure of the anastomosis
site. The late rupture can occur at the same site, but is due to
the biologic effects of the cells and blood vessels coming into the
repair site.
[0035] The tissue-generating implant of the present invention
preferably comprises a plurality of microparticles, which can
comprise solid microparticles in representative embodiments. In
modified implementations, the microparticles may not be altogether
solid, such as implementations involving hollow or porous
microparticles. As used herein, the term `microparticles` refers to
particles (e.g. in a dust or powder form) possessing an average
diameter of 500 microns or less. Typically, the average diameter
will be greater than about 20 microns rendering the microparticles
too large to be `eaten` by monocytes. The microparticles can have
diameters sufficient to keep them from being washed away through
lymph tracts or other tissue tracts from the implantation site. If
the microparticles do not have a spherical form, then the diameter
as used herein refers to the greatest diameter of the smallest
cross sectional area. It is, however, also possible to use smaller
microparticles ranging from 5 to 10 microns in diameter. Typically,
the microparticles will have an average diameter less than about
200 microns. In representative embodiments, the microparticles can
have an average diameter of about 15 to about 200 microns and in
certain implementations from about 15 to about 60 microns. In
representative configurations, the microparticles are small enough
to be injected through a fine gauge cannula or an injection syringe
into and/or onto the desired ligament or tendon. Particles having
the diameters specified herein may have a relatively minimal effect
on the surrounding tissues, i.e., muscle adjacent tendons, bone and
articular cartilage.
[0036] Due to the formed surface and size of the microparticles
used, they are not detected by the endogenous macrophages as
foreign bodies so that no defensive reaction takes place. According
to a representative embodiment, the microparticles have spherical
forms or spherical-like forms capable of forming closely-packed
arrangements at the site where they have been implanted and further
capable of being individually encapsulated by tissue and material
such as collagen
[0037] The microparticles, which in a representative embodiment may
comprise PMMA spherical beads, after being inserted into the
ligament or tendon, may be encapsulated by delicate capsules of
connective tissue and/or are embedded into connective-tissue tissue
or fibers and remain stationary in the tissue. Use of a
biocompatible medium as described herein is not mandatory since the
microparticles can be inserted (e.g., placed) or injected also
without a biocompatible medium into the body.
[0038] Once placed into the ligament or tendon, the
tissue-generating implant may mimic or provide a substitute for at
least one characteristic of the physiologic structure of the
ligament or tendon. For example, the tissue-generating implant may
mimic and/or operate as a partial artificial part of the ligament
or tendon. Accordingly, a morphology of the ligament or tendon may
be altered or improved following implantation of the
tissue-generating implant. For instance, the accumulation of the
microparticles of the tissue-generating implant and/or the
accumulation of scar tissue around the microparticles within the
ligament or tendon can impart a certain physical bulking or
stability to the interior ligament or tendon. Later testing after
the tissue-generating implant has matured (e.g., been incorporated
into the host tissue through, for example, formation of permanent
scar tissue around the microparticles of the implant) can yield an
increase in, for example, the strength of the ligament or
tendon.
[0039] Regarding maturation of the microparticles, which in a
representative embodiment may comprise PMMA spherical beads, as a
result of the size and physical stability of the PMMA beads, they
cannot be phagocytised or lysed. In order to isolate the foreign
body, the animal body can only fibrotically wall off the foreign
bodies in the form of scar tissue. Such a process takes place with
almost any foreign body which cannot be destroyed by the animal
body. To the extent present, the fibrotic growth of connective
tissue is a natural reaction to the lesion of the tissue caused by
the insertion instrument and to the presence of the microparticles.
The fibrotic reaction may occur during 3-6 months after injection
of the tissue-generating implant due to the smooth and chemically
inert surfaces of the microparticles (e.g., PMMA beads). From then
on, the beads remain in the tissue without reaction and provide for
the formation and existence of permanent fibrovascular connective
tissue.
[0040] The tissue-generating implant can in one implementation
comprise a histocompatible solid in the form of a powder. The
microparticles forming the solid may be incorporated into a
biocompatible medium and injected, for instance, with an injection
needle at the injury site.
[0041] It can be advantageous for the microparticles used according
to an embodiment of the present invention to have a smooth surface
and be free from corners and edges, such that the microparticles
don't have sharp transitions on their surfaces. In addition they
may not have peaks of any kind or tapered projections. According to
one implementation, the surface does not have pores. In another
implementation, the surfaces may comprise pores. Although smooth,
and especially spherical particles can be advantageous, in some
embodiments, microparticles of with corners or peaks or the like
may still be used in the present ligament and tendon treatment
application.
[0042] In many advantageous embodiments, the transition from one
outer surface to the other outer surface of the microparticles as
used according to one embodiment of the present invention occurs in
a continuous manner. If such transitions are present, as is the
case for the edges of a cube, such transitions may be smoothed.
According to an embodiment of the present invention, microparticles
which are crystalline (for instance needle-shaped) or
microparticles which have been obtained by mechanically breaking up
greater units into small pieces, are not used to the extent the
microparticles possess the above-mentioned sharp edges and corners.
Due to the smooth surface structure damage to cells and other
tissue structures is minimized. In addition, the danger of causing
reactions of the tissue, such a foreign body reactions or granulous
formation, which may be followed by infections, is minimized.
[0043] In one implementation, dynamically balanced microparticles
and in particular microparticles having an elliptic or spherical
form can be used. In addition, it is possible to use microparticles
of a different geometrical form if all, or in another embodiment, a
majority, of the microparticles have a smooth and smoothed-off
surface. The inert, histocompatible material of the microparticles
used according to representative embodiments of the present
invention can comprise glass beads or glass pellets having a smooth
and/or smoothed off surface. The microparticles used, according to
representative implementations of the present invention, can
comprise a polymer, and in particular a completely cured and fully
polymerized polymer so that no remaining monomers, which may be
toxic or may cause cancer, are incorporated into the body of the
treated patient. Fully polymerized PMMA is histocompatible and can
be incorporated in the human body without harmful toxic or
carcinogenic reactions so that it can be considered as chemically
and physically inert and biocompatible. For these reasons, PMMA
polymers have already been used for manufacturing implants such as
for the plastic covering of a bone defect in the face and in the
cranium, or as in a total hip or total knee arthroplasty. The
polymer is also being used for manufacturing artificial teeth, and
for manufacturing intra-articular lenses and dialysis membranes. In
principle it is possible to use any inert histocompatible polymer
for producing the microparticles used according to the present
invention. Modified embodiments may comprise, in whole or in part,
non-polymer microparticles. In an exemplary embodiment, the
tissue-generating implant comprises one or more of the implants
described under the name Artecoll.RTM.. Exemplary embodiments are
also described in the U.S. Pat. No. 5,344,452, the entire contents
of which is incorporated herein by reference.
[0044] The implant material may comprise, for example, about 20%
substantially smooth spherical PMMA beads ranging in size from
about 32-40 micrometer diameter, and with low levels of
methylmethacrylate monomer impurities. The remaining 80% may
comprise a solution of partially denatured collagen, which may be
about 3.5% collagen in a solution of water and/or alcohol. In one
embodiment, there are about 6 million particles per cc of implant
material.
[0045] To inject the microparticles or polymer microparticles used
according to the present invention as a tissue-generating implant
for a ligament or tendon, the microparticles can be suspended in a
kind of biocompatible medium. A gel which is known per se, and is
degraded within the body, for instance, on the basis of gelatin or,
preferably, collagen, can be used as a biocompatible medium. The
biocompatible medium used according to one implementation of the
present invention can comprise a tenside, such as Tween ad, since
such a tenside changes the surface tension of water so that the
microparticles, and in particular embodiments, the polymer
microparticles, have more uniform distribution.
[0046] The inserting can comprise inserting a tissue-generating
implant into the ligament or tendon while viewing at least a part
of the ligament or tendon through a scope. The scope can comprise a
video fluoroscope, and the inserting can be fluoroscopically
guided. In one implementation, the tissue-generating implant can be
impregnated with a water soluble radiopaque dye to facilitate
visualization during the inserting of the tissue-generating implant
into the ligament or tendon. The radiopaque dye can comprise
barium.
[0047] The mixing ratio of the components of the biocompatible
medium can be chosen according to the needs, and, for example,
according to the size of the insertion device used for, or the type
of, the insertion. For the application or injection of the
tissue-generating implant used according to an embodiment of the
present invention, the microparticles can be suspended or slurried
in a fluid inert medium.
[0048] Additionally, medical kits may be produced containing
elements necessary for treating and/or repairing tendons and
ligaments with the tissue-promoting implant. Such a kit may include
a quantity of the implant, and a delivery device, such as a syringe
or other applicator. One or more surgical tools used in
conventional tendon and/or ligament repair surgery are also
advantageously provided in such kits.
[0049] The above-described embodiments have been provided by way of
example, and the present invention is not limited to these
examples. Multiple variations and modifications to the disclosed
embodiments will occur, to the extent not mutually exclusive, to
those skilled in the art upon consideration of the foregoing
description. Additionally, other combinations, omissions,
substitutions and modifications will be apparent to the skilled
artisan in view of the disclosure herein. Accordingly, the present
invention is not intended to be limited by the disclosed
embodiments.
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