U.S. patent application number 15/047694 was filed with the patent office on 2016-08-25 for osteoarthritis treatment and device.
The applicant listed for this patent is ZIMMER KNEE CREATIONS, INC.. Invention is credited to Charles F. Leinberry, Peter F. Sharkey.
Application Number | 20160242833 15/047694 |
Document ID | / |
Family ID | 44936757 |
Filed Date | 2016-08-25 |
United States Patent
Application |
20160242833 |
Kind Code |
A1 |
Sharkey; Peter F. ; et
al. |
August 25, 2016 |
OSTEOARTHRITIS TREATMENT AND DEVICE
Abstract
A method for treating arthritis of a joint includes identifying
a bone lesion in a bone adjacent to the joint; and implanting in
the bone a reinforcing member in or adjacent to the bone lesion. A
kit for conducting the method includes: (a) at least one
reinforcing member having a proximal face adapted to face the
joint, a distal face adapted to face away from the joint, and a
wedge-shaped edge adapted to pierce bone, wherein the at least one
reinforcing member is planar and sterile; and (b) a container
adapted to maintain the at least one reinforcing member sterile.
Another kit includes: (a) a sterile fluid; (b) a syringe for
injecting the fluid into a bone; (c) a curing agent adapted to cure
the fluid to polymerize and/or cross-link; and (d) a container
adapted to maintain the sterility of contents of the container.
Inventors: |
Sharkey; Peter F.;
(Villanova, PA) ; Leinberry; Charles F.; (Chester
Springs, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ZIMMER KNEE CREATIONS, INC. |
Exton |
PA |
US |
|
|
Family ID: |
44936757 |
Appl. No.: |
15/047694 |
Filed: |
February 19, 2016 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14710750 |
May 13, 2015 |
9283014 |
|
|
15047694 |
|
|
|
|
14461656 |
Aug 18, 2014 |
|
|
|
14710750 |
|
|
|
|
14138262 |
Dec 23, 2013 |
8998998 |
|
|
14461656 |
|
|
|
|
13269136 |
Oct 7, 2011 |
|
|
|
14138262 |
|
|
|
|
12110434 |
Apr 28, 2008 |
8062364 |
|
|
13269136 |
|
|
|
|
60914465 |
Apr 27, 2007 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8805 20130101;
A61F 2310/00023 20130101; A61F 2002/2817 20130101; A61B 17/8825
20130101; A61F 2/28 20130101; A61B 5/055 20130101; Y10S 623/908
20130101; A61B 2017/00933 20130101; A61F 2002/2835 20130101; A61L
27/50 20130101; A61F 2310/00131 20130101; A61L 27/12 20130101; A61B
5/4585 20130101; A61B 5/4504 20130101; A61F 2002/2892 20130101;
A61L 24/02 20130101; A61L 2400/06 20130101; A61B 17/8811 20130101;
A61F 2/38 20130101; A61F 2/389 20130101; A61L 2430/02 20130101;
A61B 17/68 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88; A61L 24/02 20060101 A61L024/02; A61B 5/055 20060101
A61B005/055; A61F 2/38 20060101 A61F002/38; A61B 5/00 20060101
A61B005/00 |
Claims
1-16. (canceled)
17. A method of reinforcing bone located in a targeted bone marrow
lesion in a subchondral region of a first bone adjacent a joint in
a patient for treating the targeted bone marrow lesion, the method
comprising: identifying a bone marrow lesion in a subchondral
region of a first bone adjacent a joint in a patient so as to
establish a targeted bone marrow lesion for receiving treatment,
the subchondral region of the first bone occurring under an
articular surface of the first bone; creating, in the first bone
that contains the targeted bone marrow lesion in the subchondral
region, a subchondral injection path to an area in and/or adjacent
to the targeted bone marrow lesion for injecting an injectable
fluid material into said area for reinforcing bone located in the
targeted bone marrow lesion, wherein said creating preserves an
existing condition of the overlying articular cartilage of the
first bone adjacent the joint; and injecting an injectable and
curable fluid material into said area via the subchondral injection
path, wherein the injectable fluid material is a bone reinforcing
material that is left in the area for becoming less fluid in the
area so as to form, in situ, a bone reinforcing member for
reinforcing bone located in the targeted bone marrow lesion,
wherein the injectable fluid material is left in the area without
also delivering and leaving a solid structural implant in arid/or
adjacent to the targeted bone marrow lesion in addition to the
injectable fluid material.
18. The method of claim 17, wherein the joint is a knee joint.
19. The method of claim 18, wherein the targeted bone marrow lesion
is in a proximal tibia.
20. The method of claim 18, wherein the targeted bone marrow lesion
is in a distal femur.
21. The method of claim 17, wherein the joint is other than a knee
joint.
22. The method of claim 17, wherein said identifying includes
identifying the bone marrow lesion through use of magnetic
resonance imaging (MRI) of the joint.
23. The method of claim 22, wherein said identifying the bone
marrow lesion through use of magnetic resonance imaging (MRI) of
the joint is viewing the bone marrow lesion on an MRI of the
joint.
24. The method of claim 17, wherein said identifying includes
identifying with non-Mill identification means.
25. The method of claim 17, wherein said creating is conducted
without further creating a void inside the first bone in or
adjacent to the targeted bone marrow lesion.
26. The method of claim 17, wherein said area is in the targeted
bone marrow lesion.
27. The method of claim 17, wherein said area is adjacent to the
targeted bone marrow lesion.
28. The method of claim 17, wherein said area is up to 1 cm from
the targeted bone marrow lesion.
29. The method of claim 17, wherein the targeted bone marrow lesion
is less than 1 cm from the joint.
30. The method of claim 17 providing only a single bone reinforcing
member in said area.
31. The method of claim 17, wherein said injectable fluid material
includes a calcium phosphate.
32. The method of claim 31, wherein said calcium phosphate
comprises a calcium phosphate cement.
33. The method of claim 17, wherein said injecting includes
injecting the injectable fluid material from a pre-loaded
syringe.
34. The method of claim 33, wherein said pre-loaded syringe
includes a needle.
35. The method of claim 17, wherein said injectable fluid material
includes a non-resorbable material.
36. The method of claim 17, wherein said area is in and adjacent to
the targeted bone marrow lesion.
37. A method of reinforcing bone located in a targeted bone marrow
lesion in a subchondral region of a first bone adjacent a joint in
a patient for treating the targeted bone marrow lesion, the method
comprising: identifying a bone marrow lesion in a subchondral
region of a first bone adjacent a joint in a patient through use of
magnetic resonance imaging (MRI) of the joint so as to establish a
targeted bone marrow lesion for receiving treatment, the
subchondral region of the first bone occurring under an articular
surface of the first bone; creating, in the first bone that
contains the targeted bone marrow lesion in the subchondral region,
a subchondral injection path to an area in and/or adjacent to the
targeted bone marrow lesion for injecting an injectable fluid
material into said area for reinforcing bone located in the
targeted bone marrow lesion, wherein said creating preserves an
existing condition of the overlying articular cartilage of the
first bone adjacent the joint; and injecting an injectable and
curable fluid material into the targeted bone marrow lesion via the
subchondral injection path, wherein the injectable fluid material
is a bone reinforcing material that is left in the targeted bone
marrow lesion for becoming less fluid in the targeted bone marrow
lesion so as to form, in situ, a bone reinforcing member for
reinforcing bone located in the targeted bone marrow lesion,
wherein the injectable fluid material is left in the targeted bone
marrow lesion without also delivering and leaving a solid
structural implant in and/or adjacent to the targeted hone marrow
lesion in addition to the injectable fluid material.
38. The method of claim 37, wherein the joint is a knee joint.
39. The method of claim 38, wherein the targeted bone marrow lesion
is in a proximal tibia.
40. The method of claim 38, wherein the targeted bone marrow lesion
is in a distal femur.
41. The method of claim 37, wherein the joint is other than a knee
joint.
42. The method of claim 37, wherein said identifying the bone
marrow lesion through use of magnetic resonance imaging (MRI) of
the joint is viewing the bone marrow lesion on an MRI of the
joint.
43. The method of claim 37, wherein said creating is conducted
without further creating a void inside the first hone in or
adjacent to the targeted bone marrow lesion.
44. The method of claim 37, wherein said area is in the targeted
bone marrow lesion.
45. The method of claim 37, wherein said area is adjacent to the
targeted bone marrow lesion.
46. The method of claim 37, wherein said area is up to 1 cm from
the targeted bone marrow lesion.
47. The method of claim 37, wherein the targeted bone marrow lesion
is less than 1 cm from the joint.
48. The method of claim 37 providing only a single bone reinforcing
member in the targeted bone marrow lesion.
49. The method of claim 37, wherein said injectable fluid material
includes a ca. phosphate.
50. The method of claim 49, wherein said calcium phosphate
comprises a calcium phosphate cement.
51. The method of claim 37, wherein said injecting includes
injecting the injectable fluid material from a pre-loaded
syringe.
52. The method of claim 51, wherein said pre-loaded syringe
includes a needle.
53. The method of claim 37, wherein said injectable fluid material
includes a non-resorbable material.
54. The method of claim 37, wherein said area is in and adjacent to
the targeted bone marrow lesion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
13/269,133 filed yr Oct. 7, 2011 and entitled "OSTEOARTHRITIS
TREATMENT AND DEVICE," which is a divisional of U.S. patent
application Ser. No. 12/110,434, now U.S. Pat. No. 8,062,364, filed
on Apr. 28, 2008 and entitled "OSTEOARTHRITIS TREATMENT AND
DEVICE," which application claims priority to U.S. Provisional
Application No. 60/914,465, filed on Apr. 27, 2007 and entitled
"OSTEOARTHRITIS TREATMENT AND DEVICE," the contents of which are
herein incorporated by reference in their entirety.
FIELD
[0002] This invention relates to a method and device for treating
osteoarthritis, particularly osteoarthritis of the knee.
[0003] Osteoarthritis is the most common form of arthritis,
affecting the hands, knees, hips, spine and other joints.
Characteristics of osteoarthritis include a loss of cartilage, seen
as a reduction in the joint space, and ostetophytes (or bone
spurs).
[0004] Arthritic pain is a leading cause of lost productivity. The
cause of arthritic pain is unclear. The amount of cartilage loss
correlates poorly with the severity of pain in an afflicted
individual. Likewise, radiographic finding such as osteophytes
(bone spurs) and thickening of subchondral bone (eburination) do
not correlate with the presence or severity of pain.
[0005] Bone marrow lesions (or edemas) are very strongly associated
with knee arthritis pain (Felson et al., "The association of bone
marrow lesions with pain in knee osteoarthritis." Ann Intern Med.
2001 Apr. 3;134(7):541.9) and disease progression (Felson et al.,
"Bone marrow edema and its relation to progression of knee
osteoarthritis." Ann Intern Med. 2003 Sep. 2;139(5 Pt 1)330-6). See
also U.S. Pat. No. 6,564,083 to Stevens, which describes a method
of identifying in a patient having joint pain the susceptibility of
the patient to developing progressive osteoarthritis or loss of
joint space, by determining the presence or absence of bone marrow
edema about or of the joint. The determination is preferably made
through the use of Magnetic Resonance Imaging (MRI).
[0006] The nature and cause of bone marrow lesions is poorly
understood. Histologic examination of these lesions demonstrates
abnormal bone with areas of fibrosis, osteonecrosis and extensive
bone remodeling (Zanetti at al., "Bone Marrow Edema Pattern in
Osteoarthritic Knees: Correlation between MR Imaging and Histologic
Findings," Radiology. 2000;215:835-840). It has been suggested that
they are related to inflammation (Bollet, "Edema of the bone marrow
can cause pain in osteoarthritis and other diseases of bone and
joints." Ann Intern Med. 2001 Apr. 3:134(7):591-3), venous
hypertension (Arnoldi at al, "Intraosseous phlebography,
intraosseous pressure measurements and 99mTc-polyphosphate
scintigraphy in patients with various painful conditions in the hip
and knee," Acta Orthrop Scand. 1980; 51:19.-28), or impaired
arterial blood flow (McAlindon et al., "Magnetic resonance imaging
in osteoarthritis of the knee: correlation with radiographic and
scintigraphic findings." Ann Rheum. Dis: 1991;50:14-9. Others have
suggested these lesions reflect increased bone stress and
microfracture of the bone (see Felson et al. 2003, supra).
[0007] Knee arthritis affects millions of people and the pain
associated with this disease can be disabling. Patients who
initially present with painful knee arthritis are usually treated
non-surgically. Non-surgical treatments are modestly effective at
temporarily relieving pain, but not risk free. Pharmacologic
intervention (i.e., non-steroidal anti-inflammatory drugs) has been
reported to be associated with significant complications, such as
gastric ulcers, strokes and heart attacks. Steroid or
viscosupplement injection may lead to infection. Steroid injections
may also have systemic effects such as increased blood sugar and
hypertension. Generally speaking non-surgical interventions are
most efficacious for early arthritic disease and do not prevent
disease progression.
[0008] When patients fail non-surgical treatment, surgical
intervention is often recommended. Arthroscopic surgery has been
shown to have limited effectiveness and has a small role in the
management of knee arthritis. More invasive surgical approaches
such as high tibial osteotomy and partial or complete knee
replacement predictably relieve pain. However, these major
operations are also potentially associated with significant
morbidity and occasional modality. These risks along with the
limited durability of implantable devices influence patient and
physicians to defer surgery until the symptoms become
unbearable.
[0009] Accordingly, it is desired to provide an effective, surgical
treatment of osteoarthritis, and particularly knee arthritis pain.
It is further desired that such surgical treatment be less invasive
than high tibial osteotomy and partial or complete knee
replacement
[0010] All references cited herein are incorporated herein by
reference in their entireties.
SUMMARY
[0011] Accordingly, a first aspect of the invention comprises a
method for treating arthritis of a joint, said method comprising:
identifying a bone lesion in a bone adjacent to the joint; and
implanting in the bone a reinforcing member in or adjacent to the
bone lesion. The reinforcing member as implanted is preferably free
of artificial bones to the bone. The method preferably decreases
pain associated with arthritis and/or slows the progression of
arthritis.
[0012] A second aspect of the invention comprises a kit for
treating arthritis of a joint, said kit comprising: (a) at least
one reinforcing member comprising a proximal face adapted to face
the joint, a distal face adapted to face away from the joint, and a
wedge-shaped edge adapted pierce bone, wherein the at least one
reinforcing member is planar and sterile; and (b) a container
adapted to maintain the at least one reinforcing member
sterile.
[0013] A third aspect of the invention comprises a kit for treating
arthritis of a joint, said kit comprising: (a) a sterile (b) a
syringe for injecting the fluid into a bone; (c) a curing agent
adapted to cure the fluid to polymerize and/or cross-link; and (d)
a container adapted to maintain the sterility of contents of the
container.
[0014] A fourth aspect of the invention comprises a method for
treating arthritis of a joint, said method comprising: (a)
identifying a bone lesion in a bone adjacent to the joint; and (b)
implanting in the bone a reinforcing member in or adjacent to the
bone lesion, wherein the method stabilizes the bone in order to
prevent further biomechanical breakdown of the bone and of adjacent
meniscal tissues, and alleviates pain in the joint.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The invention will be described in conjunction with the
following drawings in which like reference numeral designate like
elements and wherein:
[0016] FIG. 1 is a magnetic resonance image (2D IR 1900/90/25.0 COR
200.times.180; 4.0 FFS; 256.times.144 pr.) of an arthritic knee on
which is overlaid a side view of an embodiment of the reinforcing
member of the invention;
[0017] FIGS. 2A, 2B and 2C are overhead views of three embodiments
of the reinforcing member of the invention; and
[0018] FIG. 2D is a side of the embodiment of FIG. 2B.
DESCRIPTION OF THE EMBODIMENTS
[0019] The invention is based on our theory that bone lesions
detected by MRI represent overstressed bone. Bone is continuously
fatigued and damaged by everyday activity. However, bone is a
living tissue and bone repair occurs in concert. Certain
pathological processes, such as loss of joint cartilage, can
disturb the equilibrium between bone damage and bone repair.
Cartilage protects underlying bone shielding it from stress. In
addition, loss of cartilage leads to joint deformity further
increasing bone stress. Overstressed bone sustains more damage than
repair, which results pain.
[0020] The invention enhances the strength of bone, shielding bone
from excessive stress. Strengthening the bone in accordance with
the invention shifts the damage/repair equilibrium toward repair.
In addition, strengthening the bone reduces, reverses and/or
prevents the deformation of overstressed bone, which should relieve
pain and slow arthritic disease progression within the underlying
bone and adjacent meniscal tissues (cartilage).
[0021] The invention provides an additional treatment option for
patients suffering with arthritic pain, particularly in the knee.
Those individuals who have exhausted non-surgical care, but are not
symptomatic enough or not prepared for other reasons (emotional,
financial, etc.) to undergo more major surgical interventions, are
ideal for treatment using the present invention. The method of the
invention should be considered minor or outpatient surgery. The
risk of complications if expected to be significantly less then
with major arthritic surgery, such as high tibial osteotomy and
partial or total knee replacement. Preferred embodiments of the
inventive treatment stabilize the defect in the subchondral
(underlying) bone in order to prevent further biomechanical
breakdown of the bone and of the adjacent meniscal tissues, and
alleviate the corresponding pain in the joint.
[0022] The method of the invention comprises identifying a bone
lesion in a bone adjacent to the joint, and implanting in the bone
a reinforcing member in or adjacent to the bone Lesions. Referring
to FIG. 1, an arthritic human knee comprises femur 10 and tibia 12.
Bone lesion 14 of tibia 12 presents as a focally increased signal
in the marrow in an MRI of the knee. in certain embodiments,
coronal spin-echo fat-saturated proton density and T2-weighted
fat-saturated magnetic resonance images are preferred. Bone lesions
thought to be associated with arthritic are less than 10 cm or 5 cm
or cm from the joint. Thus in preferred embodiments, the invention
treats bone lesions which are from 0 to 10 cm from the joint, or 0
to 5 cm from the joint, or 0 to 1 cm from the joint.
[0023] The bone lesion is preferably identified using MRI, but in
less preferred embodiments, other identification means may be
employed. For example, bone lesions can be identified using
Technetium-99 bone scans, because there is a close correlation
between the presence of activity noted on Technetium-99 bone scans
and bone marrow lesions. In embodiments of the invention employee
MRI, any MRI technology that reveals bone marrow lesions can be
used, for example, open MRI, low field strength MRI, extremity MRI,
whole body scanner MRI or the like.
[0024] Reinforcing member 14 is preferably selected in accordance
with the guidance provided by the following bone lesion grading
system.
TABLE-US-00001 Bone Lesion Grading System Bone Lesion Class
Dimension Comments I <1 mm Bone healing is likely and resorbable
graft materials are appropriate. Non-limiting exemplary materials
for use as the reinforcing member include hyaluronic acid (HA),
calcium phosphate (CaP) grafts, and cements (CaP & PMMA). II
1-3 mm Bone healing is more challenging and a semi-structural graft
material is appropriate. Non-limiting exemplary materials for use
as the reinforcing mbmer include HA, CaP, cements (CaP & PMMA),
and structural implants of metal and/or polymer. III 3-5 mm Bone
healing is less likely, and thus structural non- resorbing support
is appropriate. Non-limiting exemplary materials for use as the
reinforcing member include CaP cements, PMMA cements, and
structural implants of metal and/or polymer. IV >5 mm Bone
healing is unlikely, and thus a permanent structural implant is
required. Non-limiting exemplary materials for use as the
reinforcing member include PMMA cements, and structural implants of
metal and/or polymer.
[0025] FIG. 1 shows a preferred example of how reinforcing member
16 could be implanted in bone lesion 14. It is also within the
scope of the invention to implant the reinforcing member adjacent
to the bone lesion. For example, the reinforcing member can be
implanted adjacent to a side of the bone lesion proximal to the
joint and/or adjacent to a side of the bone lesion distal to the
joint. One or more than one, reinforcing member can be implanted in
and/or adjacent to a bone lesion. A reinforcing member is adjacent
to a bone lesion if it is less than 10 cm away from an outer
surface of the bone lesion. Adjacent reinforcing members can be in
contact with an outer surface of the bone lesion. Thus in preferred
embodiments, an adjacent reinforcing member can be from 0 to 10 cm
from the bone lesions, or 0 to 5 cm from the bone lesion, or 0 to 1
cm from the bone lesion.
[0026] It is also preferred that the reinforcing member as
implanted be free of bonds to the bone. Thus, the reinforcing
member is preferably not, for example, glued, cemented, stapled,
stitched, clamped or screwed to the bone. However, the expression
"free of artificial bonds to the bone" does not exclude from such
embodiments the possibility that bonds are formed by biological
processes in situ.
[0027] The reinforcing member is implants in the bone in or
adjacent the bone lesion such that a proximal face faces the joint
and a distal face faces away from the joint. Preferably, the
reinforcing member is selected or modified (e.g., cut, torn, etc.)
such that a maximum dimension of the proximal face exceeds a
maximum dimension of the bone lesion. It is also within the scope
of the invention for the maximum dimension of the bone lesion to
equal or exceed a maximum dimension of the proximal face. Thus, the
reinforcing member can be larger, smaller or the same size as the
bone lesion. The reinforcing member is preferably implanted such
that the proximal face is perpendicular to a longitudinal axis of
the bone. It is preferred that the proximal and/or distal faces be
the primary load bearing surfaces.
[0028] In certain embodiments, a syringe (optionally with a needle)
can be used to inject a fluid into a bone so as to form the
reinforcing member in situ. This step can be conducted with or
without first creating an opening in the bone. The fluid is
preferably a liquid, semi-solid, gel, hydrogel dispersion or
slurry. After injection, the fluid can remain in its
originally-injected state, or can cure to a less fluid state. For
example, the injected fluid can cross-link or polymerize from a
liquid to form a semi-solid, gel or solid. Fluids that cure in situ
can be self-curing or can cure in response to curing means, such
as, e.g., radiation (e.g., UV light), heat (e.g., body
temperature), moisture and/or a curing agent. See, e.g., U.S. Pat.
No. 6,818,018 to Sawhney and U.S. Pat. No. 6,280,474 to Cassidy et
al.
[0029] In certain embodiments, the reinforcing member is a solid or
a non-fluid material that is not amenable to injection in to the
bone. In these embodiments, the surgeon creates a small opening in
the vicinity of the bone lesion. Suitable surgical tools for this
task include standard boric instruments (e.g., chisels, drills,
etc.) and instruments specifically designed for use in the method
of the invention. It is also possible to use the wedge-shaped edge
of the reinforcing member to pierce the bone, preferably with
assistance from a hammer.
[0030] Although it is within the scope of the invention for the
surgeon to implant the reinforcing member by studying a previously
captured image of the bone lesion and using his or her own senses
to estimate the location and boundaries of the bone lesion, it is
preferred that the surgeon be provided with additional guidance
during surgery. For example, surgery can be conducted using
real-time imaging, robotic devices, braces for maintaining the
joint in a position consistent with captured images of the joint
and/or labels. See, e.g., U.S. Pat. No. 6,711,432 to Krause et al.
Suitable labels include but are not limited to radioactive labels,
such as Technetium-99 and objects, such as fiducial markers.
[0031] Postoperatively, patients may be required to maintain
partial weight bearing and use ambulatory aids. Depending upon the
physician's direction, full weight bearing may be possible. Routine
post intervention physical therapy will likely be required.
Additionally, patients will need routine post intervention care,
observation and follow-up.
[0032] FIG. 2 shows several different embodiments of reinforcing
members of the invention. FIG. 2A shows reinforcing member 16
having a triangular profile, FIG. 2B shows reinforcing member 16
having a rectangular profile and FIG. 2C shows reinforcing member
16 having a circular profile. Reinforcing member 16 is preferably
planar, as been from FIG. 2D, which shows a side view of the
rectangular embodiment of FIG. 2C. The term "planar" as used herein
refers to three-dimensional objects which are relatively long in
two dimensions and relatively short in a third dimension. Planar
reinforcing members in accordance with the invention can have a
thickness which is .ltoreq.50% of the length and .ltoreq.50% of the
width of a rectangular reinforcing member (or .ltoreq.50% of the
diameter in the case of a circular reinforcing member or
.ltoreq.50% of the height and .ltoreq.50% of the base in the case
of a triangular reinforcing member).
[0033] As can be seen in FIG. 2D, reinforcing member 6 has
wedge-shaped edge 18 on at least one edge thereof. Wedge-shaped
edge 18 is adapted to facilitate the step of driving reinforcing
member 18 into the bone. Thus, the particular angle and other
dimensions of the wedge are dictated by factors that are known in
the art. Preferably, wedge-shaped edge 18 is similar to that found
on standard surgical tools such as osteotomes or on implants such
as blade plates or osteotomy staples.
[0034] Reinforcing member 16 comprises a physiologically compatible
material that has sufficient durability to reinforce the
overstressed bone of the bone lesion and bear physiologic loads.
Preferred materials for the reinforcing member include metals, such
as titanium, stainless steel, alloys of cobalt and chrome,
tantalum, alloys of titanium and nickel and other superelastic
metal alloys, such as taught by U.S. Pat. No. 6,527,810. Titanium
"foam", tantalum, trabecular metals, nanoceramics or other hightly
porous nanomaterials, and chrome cobalt are particularly preferred.
Other embodiments comprise the use of bone, such as autografts,
allografts, and artificial or synthetic bone substitutes. Certain
embodiments comprise the use of polymeric materials.
[0035] Reinforcing member 16 is preferably osteogenic,
osteoconductive and/or osteoinductive. The term "osteogenic" as
used herein refers to the ability of the reinforcing member to
promote the growth of new bone tissue. The term "osteoinductive" as
used herein refers to the ability of the reinforcing member to
recruit cells from the host that have the potential for forming new
bone and repairing bone tissue. The term "osteoconductive" as used
herein refers to the ability of a non-osteoinductive reinforcing
member to serve as a substrate supporting bone growth.
Osteoconductive materials that are suitable for use in the present
invention are biologically acceptable and include but are not
limited to collagen and the various forms of calcium phosphates
including hydroxyapatite, tricalcium phosphate, and fluorapatite.
Suitable osteoinductive substances include but are not limited to
bone morphogenetic proteins (e.g., rhBMP-2) demineralized bone
matrix, transforming growth factors (e.g., TGF-beta), osteoblast
cells, and various other organic species known to induce bone
formation. The osteoconductive and osteoinductive properties may be
provided by bone marrow, blood plasma, or morselized bone of the
patient, or commercially available materials. Osteoinductive
materials such as BMP may be applied to articles of the invention,
for example, by immersing the article in an aqueous solution of
this material in a dilute suspension of type I collagen.
Osteoinductive materials such as TGF-beta may be applied to an
article of the invention from a saline solution containing
effective concentration of TGF-beta, or may be carried in the
resilient material.
[0036] The reinforcing member can be resorbable, but is preferably
non-resorbable, particularly when used to treat a chronic
condition, such as osteoarthritis.
[0037] In certain embodiments, electrical stimulation is applied to
the bone to promote bone healing.
[0038] The reinforcing member can be provided alone or in a kit
according to the invention. A first embodiment of the kit includes
at least one reinforcing member, which is sterile, and a container
adapted to maintain the sterility of the at least one reinforcing
member. Preferably, the containers are sealed flexible bags. The
term "sterile" as used herein denotes a condition in which an
object has a sterility assurance level (SAL) or 10.sup.-3 or less
(preferably 10.sup.-3 of less) in accordance with current FDA
guidelines for medical devices and as measured by AAMI/ISO
11607-1.
[0039] The first embodiment of the kid can optionally include an
assortment of reinforcing members of various sizes and/or shapes
appropriate for use with a variety of bone lesions. The kit can
also include instructions for use, e.g., printed on the container
and/or on inserts within the container. The kit can still further
include a tool for adjusting the size of the reinforcing member, a
hammer for driving the reinforcing member into the bone and/or a
bone filler to seal the open end of the channel in the bone in
which the reinforcing member resides. Suitable bone fillers include
but are not limited to materials comprising beta-tricalcium
phosphate (e.g., VITOSS, PROOSTEON 500R made by E-Interpore-Cross
International), hydroxyapatite (e.g., OSTEOGRAF made by Ceramed
Denta, Inc., Lakewood, Colo.), calcium carbonate, calcium sulfate
(e.g., OSTEOSET and ALLOMATRIX made by Wright Medical Technology,
Inc.), calcium phosphate (e.g., CALCIBON made by Merck & Co.
Inc., Whitehouse Station, N.J., and NORIAN SRS made by
Synthes-Strates, Switzerland), synthetic bone fillers e.g.,
CORTOSS) and/or processed bone fillers (e.g., BIOOSS made by
Geistlich Biomaterials, Inc., Switzerland). See U.S. Pat. No.
7,166,570.
[0040] A second embodiment of the kit includes a fluid, a syringe
for injecting the fluid into a bone and a container adapted to
maintain the sterility of the contents of the container. This
embodiment of the kit can further comprise a needle and premeasure
portions of ingredients in a plurality of separate vials. As with
the first embodiment of the kit, this embodiment can optionally
include instructions for use, e.g., printed on the container and/or
on inserts within the container. The kit can further include bone
tools for providing a channel in the bone in which the fluid is
injected and/or a bone filler to seal the open end of the channel
in the bone in which the reinforcing member resides. The kit can
include curing agents (i.e., polymerizing agents, catalysts and/or
crosslinking agents) as separate ingredients to be added to the
injected fluid. The kit can include other curing means, such as a
UV light source or other device for generating radiation. The fluid
can be preloaded in the syringe for injection. In some embodiments,
a multiple barrel syringe can be included for in situ mixing of
ingredients that must be stored separately in different barrels of
the syringe (e.g., monomers and polymerizing agent, or polymers and
crosslinking agent, etc.).
[0041] While the invention is described in the context of
osteoarthritis of the knee, it is not limited to such condition.
Other conditions that can be treated in accordance with the
invention include but are not limited to osteoarthritic of joints
other than the knee.
[0042] While the invention has been described in detail and with
reference to specific examples thereof, it will be apparent to one
skilled in the art that various changes and modifications can be
made therein without departing from the spirit and scope
thereof.
* * * * *