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Cancellous constructs, cartilage particles and combinations of cancellous constructs and cartilage particles

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Title: Cancellous constructs, cartilage particles and combinations of cancellous constructs and cartilage particles.
Abstract: Constructs that are at least partially constructed of allograft cancellous bone are disclosed, along with cartilage particles that may be used with the constructs for repairing articular cartilage defects. A multi-piece construct includes a base member, a cap member and at least one pin that secures the cap member to the base member. The base member may be constructed of mineralized cancellous bone, and is used to replace the subchondral bone removed when a surgeon cuts a bore in the area of an adjacent cartilage defect. The base member includes a blind bore and first and second through-going transverse bores in opposite sides of a wall of the base member. The cap member includes an upper section that has a thickness that is similar to that of a patient's surrounding articular cartilage layer and a stem depending from the upper section that is dimensioned to be received in and by the blind bore of the base member. The stem includes a transverse through-going bore, which may be aligned with the transverse through-going bores of the base member to receive the pin therein when the construct has been assembled. The cap member is at least partially formed of demineralized allograft cancellous bone, into which a mixture containing lyophilized, freeze-milled allograft cartilage particles may be infused for the repair of articular cartilage defects. The cartilage particles have a size within a range of from about 10 microns to about 210 microns. ...


USPTO Applicaton #: #20090319045 - Class: 623 1611 (USPTO) - 12/24/09 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Implantable Prosthesis >Bone



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The Patent Description & Claims data below is from USPTO Patent Application 20090319045, Cancellous constructs, cartilage particles and combinations of cancellous constructs and cartilage particles.

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RELATED APPLICATIONS

This application is a continuation-in-part of (i) U.S. patent application Ser. No. 11/657,042 filed Jan. 24, 2007; (ii) U.S. patent application Ser. No. 12/043,001 filed Mar. 5, 2008; (iii) U.S. patent application Ser. No. 12/328,306 filed Dec. 4, 2008; and (iv) U.S. patent application Ser. No. 12/079,629 filed Mar. 26, 2008, which is a divisional of U.S. patent application Ser. No. 10/960,960 filed Oct. 12, 2004, now abandoned; and also claims priority under 35 U.S.C. § 119(e) to (v) U.S. Provisional Patent Application Ser. No. 61/189,252 filed Aug. 15, 2008, and (i) U.S. Provisional Patent Application Ser. No. 61/205,433 filed Jan. 15, 2009. This application is also related to the following commonly owned patent applications: (a) U.S. Provisional Patent Application Ser. No. 60/904,809 filed Mar. 6, 2007, and (b) U.S. Provisional Patent Application Ser. No. 60/996,800 filed Dec. 5, 2007. All of the foregoing related patent applications are incorporated by reference herein in their entirety.

BACKGROUND OF THE INVENTION

Chondrogenesis is the process of growth and differentiation of cartilage cells (chondrocytes), leading to the proliferation of such cells and the development of a robust, specialized extracellular matrix surrounding such cells. Cartilage is the specialized matrix of chondrocytes and particular cartilage extracellular matrix components surrounding such chondrocytes. Disordered growth and repair of cartilage cells results in tissue with primarily fibrotic morphology, as opposed to the cartilage extracellular matrix resulting from normal growth and development of chondrocytes and having characteristic proteoglycan and collagen II components.

Articular cartilage injury and degeneration present medical problems to the general population which are constantly being addressed by orthopedic surgeons. Thousands of arthroplastic and joint repair procedures are performed every year in the United States, including total hip and total knee arthroplasties and open arthroscopic procedures to repair cartilaginous defects of the knee.

Reference is now made to FIG. 1, which illustrates a knee joint having articular cartilage tissue forming a lining which faces the joint cavity on one side, and is linked to the subchondral bone plate by a narrow layer of calcified cartilage tissue on the other side. Articular cartilage consists primarily of extracellular matrix with a sparse population of chondrocytes distributed throughout the tissue. Articular cartilage is composed of chondrocytes, type II collagen fibril meshwork, proteoglycans, and water. Active chondrocytes are unique in that they have a relatively low turnover rate and are sparsely distributed within the surrounding matrix. The collagens give the tissue its form and tensile strength and the interaction of proteoglycans with water gives the tissue its stiffness to compression, resilience and durability. The articular cartilage provides a low friction bearing surface over the bony parts of the joint. If the lining becomes worn or damaged resulting in lesions, joint movement may be painful or severely restricted. Whereas damaged bone typically can regenerate successfully, articular cartilage regeneration is quite limited because of its limited regenerative and reparative abilities.

Articular cartilage lesions generally do not heal, or heal only partially under certain biological conditions, due to the lack of nerves, blood vessels and a lymphatic system. The limited reparative capabilities of articular cartilage usually results in the generation of repair tissue that lacks the structure and biomechanical properties of normal articular cartilage. Generally, the healing of the defect results in a fibrocartilaginous repair tissue that lacks the structure and biomedical properties of articular cartilage and degrades over the course of time. Articular cartilage lesions are frequently associated with disability and with symptoms such as joint pain, locking phenomena and reduced or disturbed function. These lesions are difficult to treat because of the distinctive structure and function of articular cartilage. Such lesions are believed to progress to severe forms of osteoarthritis. Osteoarthritis is the leading cause of disability and impairment in middle-aged and older individuals, entailing significant economic, social and psychological costs. Each year, osteoarthritis accounts for millions of physician visits and thousands of hospital admissions.

BRIEF

SUMMARY

OF THE INVENTION

The present invention is directed towards a particulate allograft cartilage material, which may optionally be incorporated into an allograft cancellous bone construct, that exhibits improved chondrogenesis and decreased fibrous tissue formation in both in vivo and in vitro environments. The cartilage defect repair material includes lyophilized, freeze-milled allograft cartilage particles having a size within a range of from about 10 microns to about 210 microns.

A method of placing the aforementioned cartilage defect repair material in a cartilage defect site includes the steps of (a) cutting a patient's tissue to remove diseased cartilage from the cartilage defect site; (b) placing said cartilage defect repair material into the cartilage defect site; and (c) placing a cover over the placed cartilage defect repair material.

A method for making the aforementioned cartilage defect repair material includes the steps of lyophilizing allograft cartilage; and freezemilling the allograft cartilage so as to form cartilage particles.

A method of repairing articular cartilage includes the step of placing a therapeutically effective amount of the aforementioned cartilage defect repair material into a cartilage defect site, wherein, subsequent to placement of the therapeutically effective amount of the cartilage defect repair material into the cartilage defect site, a greater percentage of repair tissue generated in the cartilage defect site is articular cartilage as compared to equivalent cartilage defect sites left untreated or treated with microfracture.

A construct according to the present invention includes a cap member that is at least partially derived from demineralized cancellous bone, and a base member having first and second ends. The base member includes a first bore extending into the base member from the first end in a generally axial direction, and a second bore extending generally transversely from an exterior wall of the base member to the first bore. The cap member includes an upper section and a stem depending from the upper section, wherein the stem is dimensioned to insertably engage the first bore such that the upper section is adjacent the first end of the base. The stem includes a third bore extending generally transversely into the stem from an exterior surface thereof, wherein the third bore is alignable with the second bore when the stem is in engagement with the first bore. The construct also includes at least one pin which is dimensioned to engage the second and third bores when the second and third bores are aligned, thereby securing the cap member to the base member. The cap member includes a plurality of lyophilized, freeze-milled cartilage particles, at least a majority of which have a dimension, when dry, that does not exceed 210 microns.

Another construct according to the present invention includes a cap member that is at least partially derived from demineralized cancellous bone, and a base member having first and second ends, a first bore extending into the base member from the first end in a generally axial direction, a second bore extending generally transversely from an exterior wall of the base member to the first bore, and a third bore extending generally transversely from the exterior wall of the base member to the first bore. The third bore is formed opposite the second bore and is alignable with the second bore. The base member includes an upper annular edge adjacent the first end and the first bore, and an island formed in the so as to be substantially concentrically positioned with respect to the upper annular edge, and to form an annular recess between the island and an interior wall of the base member adjacent the upper annular edge. The cap member includes an upper section and a stem depending from the upper section. The stem is dimensioned to insertably engage the first bore, such that the upper section is adjacent the first end of the base, wherein the is hollow and includes a cavity formed therein which is dimensioned to receive the island therein. The annular recess of the base member is dimensioned to receive the stem therein. The stem includes a fourth bore extending generally transversely into the stem from an exterior surface thereof. The fourth bore is alignable with the second bore and the bore when the stem is in engagement with the first bore. The stem includes a fifth bore extending generally transversely into the stem from the exterior wall thereof. The fifth bore is formed opposite the fourth bore and alignable with the second bore and the third bore when the stem is in engagement with the first bore. The island includes a sixth bore which extends generally transversely between opposed exterior surfaces of the island. The sixth bore is alignable with the second bore, the third bore, the fourth bore and the fifth bore when the stem is in engagement with the first bore. The construct also includes at least two pins which are dimensioned to engage the second bore, the third bore, the fourth bore, the fifth bore and the sixth bore when the second bore, the third bore, the fourth bore, the bore and the bore are aligned, thereby securing the cap member to the base member. The cap member includes a plurality of lyophilized, freeze-milled cartilage particles, at least a majority of which have a dimension, when dry, that does not exceed 210 microns.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application contains at least one drawing executed in color, which includes a color photograph. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee.

The present invention will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the present invention.

FIG. 1 is an anatomical illustration of a knee joint having articular cartilage in which a lesion has formed;

FIG. 2 is an exploded perspective view of a multi-piece cancellous construct produced in accordance with an exemplary embodiment of the present invention;

FIG. 3 is a top perspective view of the multipiece construct of FIG. 2, as assembled;

FIG. 4 is a cross-sectional view of the multi-piece construct of FIG. 2 which has been placed in a bore of a cartilage defect area in a patient according to a method performed in accordance with the present invention;

FIG. 5 is a top plan view of a base member employed by the multi-piece construct of FIG. 2;

FIG. 6 is a side elevational view of a base member and a cap member employed by the multi-piece construct of FIG. 2, wherein the base member and cap member have been coupled;

FIG. 7 is a side elevational view of the coupled base member and cap member of the multi-piece construct of FIG. 2 in which the coupled base member and cap member have been rotated 90° from their position shown in FIG. 6;

FIG. 8 is a top perspective view of the base member employed by the multi-piece construct of FIG. 2;

FIG. 9 is a bottom perspective view of the cap member employed by the multi-piece construct of FIG. 2;

FIG. 10 is a top plan view of the cap member of FIG. 9;

FIG. 11 is a side elevational view of the cap member of FIG. 9;

FIG. 12 is a side elevational view of the cap member of FIG. 9 in which the cap member has been rotated 90° from its position shown in FIG. 11;

FIG. 13 is an exploded perspective view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 14 is an exploded perspective view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 15 is an exploded perspective view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 16 is a bottom perspective view of a cap member employed by the multi-piece construct of in FIG. 15;

FIG. 17 is a top perspective view of the multipiece construct of FIG. 15, as assembled;

FIG. 18 is a schematic cross-sectional view, taken along lines X—X and looking in the direction of the arrows, of the multipiece construct of FIG. 17;

FIG. 19 is a top perspective view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 20 is a top perspective view of a base member employed by the multi-piece construct illustrated in FIG. 19;

FIG. 21 is a top perspective view of a ring-shaped support member of the construct illustrated in FIG. 19;

FIG. 22 is a side elevational view of the construct illustrated in FIG. 19, as ambled;

FIG. 23 is a cross-sectional view, taken along line XI-XI and looking in the direction of the arrows, of the construct illustrated in FIG. 22;

FIG. 24 is an exploded perspective view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 25 is a side elevational view of the construct illustrated in FIG. 24, as assembled;

FIG. 26 is a cross-sectional view, taken along line XII-XII and looking in the direction of the arrows, of the construct illustrated in FIG. 25;

FIG. 27 is a schematic illustration of an assembly of multiple cancellous constructs produced in accordance with another embodiment of the present invention;

FIG. 28 is side elevational view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 29 is an exploded perspective view of the construct illustrated in FIG. 28;

FIG. 30 is an exploded perspective view of a multi-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 31 is a top perspective view of a one-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIG. 32 is a schematic illustration of the one-piece construct of FIG. 31 as it is being inserted into a cartilage defect in accordance with a method performed in accordance with the present invention;

FIGS. 33A, 33B and 33C are top perspective views of three embodiments of a one-piece cancellous construct produced in accordance with another embodiment of the present invention;

FIGS. 34A and 34B are photographic depictions of the porosity of a demineralized component of a cancellous construct produced in accordance with an embodiment of the present invention;

FIG. 35 is a depiction of nanograms of endogenous TGF-β1 per gram of cartilage particles isolated from said cartilage particles of several subjects through guanidine HCl extraction and subsequent dialysis;

FIG. 36 is a comparison of relative amounts (nanograms) of endogenous TGF-β1 per gram of cartilage particles isolated from minced and freeze-milled cartilage through guanidine HCl extraction and subsequent dialysis;

FIG. 37 is a depiction of picograms of endogenous FGF-2 per gram of cartilage particles isolated from freeze-milled cartilage particles of several tissue donors through guanidine HCl extraction and subsequent dialysis;

FIG. 38 is a depiction of nanograms of endogenous BMP-2 per gram of cartilage particles isolated from freeze-milled cartilage particles of several tissue donors through guanidine HCl extraction and subsequent dialysis;

FIG. 39 is a depiction of nanograms of endogenous BMP-14 (GDF-5) per gram of cartilage particles isolated from freeze-milled cartilage particles of several tissue donors through guanidine HCl extraction and subsequent dialysis;

FIG. 40 is a depiction of nanograms of endogenous IGF-1 per gram of cartilage particles isolated from freeze-milled cartilage particles of several tissue donors through guanidine HCl extraction and subsequent dialysis;

FIG. 41 is a view of newly synthesized articular cartilage from in vivo experimentation, demonstrating infiltration of lacunae by chondrocytes;

FIGS. 42A and 42B are views of collagen immunohistochemistry staining for collagen II, a marker of articular cartilage, showing that both cartilage particles and newly-synthesized extracellular matrix stain positive for collagen II;

FIG. 43 is a pictorial depiction of a cancellous construct, for example, of the type disclosed in the instant application;

FIG. 44 demonstrates homogenous distribution of the cartilage particles in a cap portion of the construct, as indicated by positive proteoglycan (Safranin O) staining;

FIGS. 45A-45H demonstrate relative chondrogenesis over a period of 24 weeks post-treatment: FIGS. 45A, 45C, 45E, and 45G are Safranin-O stained for proteoglycan assessment; FIGS. 45B, 45D, 45F, and 45H are anti-collagen II stained for collagen II assessment; FIGS. 45A and 45B represent microfracture; FIGS. 45C and 45D represent an empty defect; FIGS. 45E and 45F represent a construct without cartilage particles; and FIGS. 45G and 45H represent a construct in combination with (i.e., loaded with) freeze-milled cartilage particles; and

FIGS. 46-48 are graphs of the distribution of the aspect ratios of cartilage particles that were derived from three tissue donors and subjected to a particle size analysis.

While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the detailed description. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed invention.

DETAILED DESCRIPTION

OF THE INVENTION

Detailed embodiments of the present invention are disclosed herein; however it is to be understood that the disclosed embodiments are merely illustrative of the invention that may be embodied in various forms. In addition, each of the examples given in connection with the various embodiments of the invention is intended to be illustrative, and not restrictive. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. In addition, any measurements, specifications and the like shown in the figures are intended to be illustrative, and not restrictive. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

Cancellous Constructs

Cartilage repair constructs (e.g., scaffolds or implants) are disclosed herein. The term “construct”, as used hereinafter, is defined as a device that includes one or multiple components which are constructed from milled pieces of bone, or other biocompatible materials, wherein the device is intended to be implanted at the site of a tissue defect (e.g., an articular cartilage defect) to repair the defect. In one embodiment, the constructs components are constructed of allograft cancellous bone. More particularly, most or all of the components of the allograft constructs are preferably derived from dense allograft cancellous bone that may originate from proximal or distal femur, proximal or distal tibia, proximal humerus, talus, calceneus, patella, or ilium, which bones are received from a tissue donor and are stored frozen until processing time, preferably at −70° C. Components of the constructs may also be constructed of allograft cortical bone, and/or xenograft bone when the same is properly treated, or other materials, as discussed below. Cancellous bone is preferred because its porous structure enables it to act as a natural matrix for receiving and retaining therein a mixture containing cartilage particles and various bioactive chondrogenic materials for the repair of articular cartilage defects, as discussed further below. Cancellous bone also acts as a conduit for tissue ingrowth and regeneration.

In one embodiment, the constructs may be prepared according to the following procedure:

(a) The frozen donor bone is allowed to thaw in warm USP water (i.e., water that is purified to have a sterility level in accordance with United States Pharmacopeia standards). Once thawed, the bone is processed, with the cancellous bone tissue being cut therefrom into sheets or blocks.

(b) The cancellous bone blocks are flushed with high-pressure USP water in order to remove from the cancellous bone blocks any lipids therein and the bone fragments and/or shavings produced during the cutting of the blocks.

(c) The cancellous bone blocks are placed in an agitating device, and treated with a detergent used in delipidization (e.g., Polysorbate 80) to further eliminate/minimize the lipid content of the blocks. After delipidization, the cancellous bone blocks are cleaned with USP water and dried.

(d) The cancellous bone blocks are soaked in USP water prior to milling. The blocks are milled into the desired shapes for the various components of the construct using a milling machine.

(e) After milling, the construct components are rinsed with USP water and trimmed.

(f) The finished construct components are then soaked in detergent (e.g., Polysorbate 80).

(g) Following the detergent soak, the construct components are rinsed and soaked in USP water and dried.

(h) The construct components are then soaked in an antibiotic solution (e.g., gentamicin) and rinsed and soaked in USP water and dried.

(i) At least some of the construct components (i.e., the base member and pins described below) are then soaked in detergent (e.g., Polysorbate 80). Following the detergent soak, these construct components are rinsed and soaked in USP water and dried. These construct components are then soaked in a hydrogen peroxide solution, and then rinsed and soaked in USP water and dried.

(j) At least one of the construct components (i.e., the cap member described below) is demineralized using techniques known in the art, such as a soak in 0.6N HCl (or any other suitable dilute acid) for a period of time sufficient to attain a predetermined mineral content level (e.g., less than 0.5% w/w residual calcium). Following demineralization, the demineralized construct component(s) is rinsed and cleaned with USP water. The demineralized construct component(s) may also be cleaned with a hydrogen peroxide solution. The demineralization process is further discussed herein below in connection with specific construct component(s).

(k) The demineralized construct component(s) may be soaked in a buffered solution having a pH of 7.4 (e.g., Sorenson phosphate buffered saline (PBS) solution) or a similar or higher pH level to restore the pH of the demineralized construct component(s) a physiological level of about 7.0. Following the buffered solution soak, the demineralized construct component(s) is rinsed and cleaned with USP water and dried.

(l) The construct components are assembled, as further described below.

(m) The assembled construct is then be subjected to a tissue processing protocol, including, for example, a soak in ethanol (e.g., 70% SDA-3A ethanol). The assembled construct is then rinsed with USP water and dried.

Modifications to the above construct preparation procedure may be made.

The construct components are then frozen at −20° C. to −100° C., preferably at −70° C., and lyophilized (i.e., freeze-dried) to reduce the water content to be within a range of about 0.1% to about 8.0%. The lyophilized construct components are then secured in an appropriate moisture barrier package for long-term storage, whereby the lyophilized construct components may be stored at room temperature for up to five years. Examples of moisture barrier packaging that may be used include a flexible foil laminate pouch and a high moisture barrier thermo formed tray heat sealed to the foil lidstock. The pouch may be made of materials that can be laminated with foil (e.g., PET, PE, LDPE, LLDPE, HDPE, Nylon), while the tray may be made of a laminate material (e.g., PETG/PCTFE laminate, PVC/PCTFE laminate, PETG/COC laminate, PVC/COC laminate, COC/PCTFE laminate). To preserve the sterility of the construct components, packaging with sterile barrier properties is used. The package may consist of more than one layer to facilitate the transfer of the construct components into the sterile field of an operating room or other sterile environments.

Alternatively, the construct components may be frozen at −20° C. to −100° C., preferably at −70° C., (i.e., without lyophilization), whereby the frozen construct components may be stored at the aforementioned temperature(s) for up to five years. The frozen construct components may be stored in a multiple-layered moisture barrier package to maintain sterility, as discussed above.

The construct components that have been processed and stored as described above are produced in various standard sizes (i.e., diameters and heights). The construct components may be assembled prior to storage, and stored unloaded (i.e., without the addition of any substance thereto), or with a lyophilized cartilage particle mixture and/or other substances loaded therein, as discussed below.

In an embodiment, the assembled construct is shaped in the form of a cylinder, for easy insertion into bores cut into a patient to remove osteochondral defect areas, as explained hereinafter. The construct may also be formed in other shapes, such as rectangular, square and oval configurations.

Prior to a surgical articular cartilage repair procedure, a surgeon may pre-order a set of constructs for use in connection with the surgery. During surgery, a surgeon selects one of the constructs having a diameter that matches the diameter of a cylindrical hole (i.e., a blind bore) that has been cut in the lesion or defect area of the host tissue (i.e., the subchondral bone and the overlying articular cartilage) of a patient, and inserts the construct into the bore. The construct that is selected by the surgeon will have a diameter sized to facilitate an interference fit between the construct and a sidewall of the bore. Alternatively, the diameter of the construct may be sized to facilitate a press-fit between the construct and the bore sidewall. Different embodiments of the construct and the associated surgical implantation procedures are disclosed in the following sections and in the corresponding drawings.

With reference to FIGS. 2-12, an embodiment of a multi-piece construct 20 is illustrated as having a base member 22 and a cap member 30 that is held fixed in place in the base member 20 by a pin 40. In an embodiment, the outer diameter of the assembled construct 20 may be within a range from about 5 mm to about 35 mm, and its overall height may be within a range from about 5 mm to about 20 mm. This embodiment of the construct is also disclosed in U.S. patent application Ser. No. 11/657,042 filed Jan. 24, 2007; U.S. Provisional Patent Application Ser. No. 60/996,800 filed Dec. 5, 2007; and U.S. patent application Ser. No. 12/328,306 filed Dec. 4, 2008, all of which are incorporated by reference herein in their entirety.

Referring now to FIGS. 2-8, the base member 22 may be constructed of mineralized cancellous bone (e.g., cancellous bone in its natural, undemineralized state containing approximately 60% mineral by weight or more). The cancellous bone of the base member 22 is used to replace the subchondral bone removed when a surgeon cuts a bore in the area of an adjacent cartilage defect. The base member 22 is shaped in the form of a cylinder (see FIGS. 2, 3 and 8) for easy insertion into bores cut into the patient to remove osteochondral defect areas. The base member 22 may also be formed in other shapes.



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stats Patent Info
Application #
US 20090319045 A1
Publish Date
12/24/2009
Document #
12381072
File Date
03/05/2009
USPTO Class
623 1611
Other USPTO Classes
623 2373
International Class
/
Drawings
35


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Allograft
Articular Cartilage
Blind
Cartilage
Defect
Defects
Graft
Infuse
Lyophilize
Micron
Opposite Side
Surge
Surgeon
Transverse


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Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor   Implantable Prosthesis   Bone