BIOCOMPATIBLE SCAFFOLDS WITH TISSUE FRAGMENTS

• US 20110091517A1
• Filed: 11/22/2010
• Published: 04/21/2011
• Est. Priority Date: 10/18/2002
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Gosiewska, Anna, Dhanaraj, Sridevi, Binette, Francois, Hwang, Julia
• Granted Patent: US 9,511,171 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3612 Cartilage, synovial fluid
• CPC Class Codes: A61L 27/3616 Blood, e.g. platelet-rich plasma
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3895 using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C12N 5/0068 General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: C12N 5/0655 Chondrocytes; Cartilage

Abstract

A biocompatible tissue repair implant or scaffold device is provided for use in repairing a variety of tissue injuries, particularly injuries to cartilage, ligaments, tendons, and nerves. The repair procedures may be conducted with implants that contain a biological component that assists in healing or tissue repair. The biocompatible tissue repair implants include a biocompatible scaffold and particles of living tissue, such that the tissue and the scaffold become associated. The particles of living tissue contain one or more viable cells that can migrate from the tissue and populate the scaffold.

Claims

1-97. -97. (canceled)

98. A biocompatible tissue implant, comprising:

a first bioimplantable scaffold; and

a plurality of cartilage tissue fragments distributed on the surface of the first scaffold, the tissue fragments having viable cells, the viable cells being capable of migrating out of the tissue fragments;

wherein the cartilage tissue fragments have a size in the range of about 0.1 mm³ to about 3 mm³.

99. The tissue implant of claim 98, wherein the first bioimplantable scaffold comprises a biocompatible polymer selected from the group consisting of a synthetic polymer, a natural polymer, an injectable gel, a ceramic material, autogeneic tissue, allogeneic tissue, xenogeneic tissue, and combinations thereof.

100. The tissue implant of claim 99, wherein the tissue implant has been incubated for a duration and under conditions effective to allow cells within the tissue fragments to populate the scaffold.

101. The tissue implant of claim 100, wherein the tissue implant is incubated for a duration in the range of about 7 days to 6 weeks.

102. The tissue implant of claim 100, wherein the tissue implant is incubated at a temperature in the range of about 20 to 40°

C. and under conditions of high humidity.

103. The tissue implant of claim 98, wherein the at least one tissue fragment comprises tissue selected from the group consisting of cartilage tissue, meniscal tissue, ligament tissue, tendon tissue, skin tissue, muscle tissue, periosteal tissue, pericardial tissue, synovial tissue, nerve tissue, kidney tissue, bone marrow, liver tissue, bladder tissue, pancreas tissue, spleen tissue, and combinations thereof.

104. The tissue implant of claim 103, wherein the at least one tissue fragment comprises autologous tissue.

105. The tissue implant of claim 98, wherein viable cells have migrated out of the plurality of tissue fragments and have populated at least a portion of an interior region of the first biocompatible scaffold, such that the cells are embedded within the scaffold.

106. The tissue implant of claim 98 further comprising a second bioimplantable scaffold wherein the second bioimplantable scaffold is disposed over a plurality of tissue fragment on the surface of the first bioimplantable scaffold, such that at least a portion of the at least one tissue fragment is disposed between at least two bioimplantable scaffolds.

107. The tissue implant of claim 98, wherein the first scaffold further comprises a reinforcing component formed of a biocompatible mesh-containing material.

108. The tissue implant of claim 98, wherein the first bioimplantable scaffold comprises a synthetic polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), poly(propylene fumarate), copoly(ether-esters), polyalkylene oxalates, polyamides, tyrosine-derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, polyurethanes, biosynthetic polymers and combinations thereof.

109. The tissue implant of claim 108, wherein the biocompatible scaffold comprises an aliphatic polyester selected from the group consisting of homopolymers or copolymers of lactides;

glycolides;

ε

-caprolactone;

hydroxybuterate;

hydroxyvalerate;

1,4-dioxepan-2-one;

1,5,8,12-tetraoxyacyclotetradecane-7,14-dione;

1,5-dioxepan-2-one;

6,6-dimethyl-1,4-dioxan-2-one;

2,5-diketomorpholine;

p-dioxanone (1,4-dioxan-2-one);

trimethylene carbonate (1,3-dioxan-2-one);

alkyl derivatives of trimethylene carbonate;

δ

-valerolactone;

β

-butyrolactone;

γ

-butyrolactone;

ε

-decalactone;

pivalolactone;

α

,α

-diethylpropiolactone;

ethylene carbonate;

ethylene oxalate;

3-methyl-1,4-dioxane-2,5-dione;

3,3-diethyl-1,4-dioxan-2,5-dione;

6,8-dioxabicycloctane-7-one; and

combinations thereof.

110. The tissue implant of claim 98, wherein the first bioimplantable scaffold comprises a polymeric foam component having pores with an open cell pore structure.

111. The tissue implant of claim 110 wherein the bioimplantable scaffold further comprises a reinforcing component formed of a biocompatible mesh-containing material.

112. The tissue implant of claim 98, wherein the first bioimplantable scaffold further comprises at least one additional biological component applied thereto.

113. The tissue implant of claim 112, wherein the at least one additional biological component comprises growth factors, matrix proteins, enzymes, cytokines, viruses, nucleic acids, peptides, isolated cells, platelets or combinations thereof.

114. The tissue implant of claim 106, wherein the second biocompatible scaffold comprises a biocompatible polymer selected from the group consisting of a synthetic polymer, a natural polymer, an injectable gel, a ceramic material, autogeneic tissue, allogeneic tissue, xenogeneic tissue, and combinations thereof.

115. The tissue implant of claim 114, wherein the second bioimplantable scaffold comprises a synthetic polymer selected from the group consisting of aliphatic polyesters, poly(amino acids), poly(propylene fumarate), copoly(ether-esters), polyalkylene oxalates, polyamides, tyrosine-derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, polyurethanes, biosynthetic polymers and combinations thereof.

116. The tissue implant of claim 115, wherein the biocompatible scaffold comprises an aliphatic polyester selected from the group consisting of homopolymers or copolymers of lactides;

glycolides;

ε

-caprolactone;

hydroxybuterate;

hydroxyvalerate;

1,4-dioxepan-2-one;

1,5,8,12-tetraoxyacyclotetradecane-7,14-dione;

1,5-dioxepan-2-one;

6,6-dimethyl-1,4-dioxan-2-one;

2,5-diketomorpholine;

p-dioxanone (1,4-dioxan-2-one);

trimethylene carbonate (1,3-dioxan-2-one);

alkyl derivatives of trimethylene carbonate;

δ

-valerolactone;

β

-butyrolactone;

γ

-butyrolactone;

ε

-decalactone;

pivalolactone;

α

,α

-diethylpropiolactone;

ethylene carbonate;

ethylene oxalate;

3-methyl-1,4-dioxane-2,5-dione;

3,3-diethyl-1,4-dioxan-2,5-dione;

6,8-dioxabicycloctane-7-one; and

combinations thereof.

117. The tissue implant of claim 98, wherein the tissue fragments have a size in the range of about 0.5 mm³ to about 1 mm³.

118. The tissue implant of claim 98, wherein the tissue fragments have a size in the range of about 1 mm³ to about 2 mm³.

119. The tissue implant of claim 98, wherein the tissue fragments have a size of about 1 mm³.