Source: http://www.google.es/patents/US9511171
Timestamp: 2017-11-17 21:34:41
Document Index: 352843026

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'application No. 2006200194', 'Application No. 04251265', 'Application No. 05256123', 'Application No. 2007', 'Application No. 2004', 'Application No. 2004', 'Application No. 2007']

Patente US9511171 - Biocompatible scaffolds with tissue fragments - Google Patentes
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...http://www.google.es/patents/US9511171?utm_source=gb-gplus-sharePatente US9511171 - Biocompatible scaffolds with tissue fragments
Número de publicación US9511171 B2
Número de solicitud US 12/951,205
También publicado como CA2445558A1, CA2445558C, DE60324075D1, EP1410811A1, EP1410811B1, US20040078090, US20110091517, US20170049931
Número de publicación 12951205, 951205, US 9511171 B2, US 9511171B2, US-B2-9511171, US9511171 B2, US9511171B2
Inventores Francois Binette, Julia Hwang, Sridevi Dhanaraj, Anna Gosiewska
Citas de patentes (397), Otras citas (71), Clasificaciones (23)
US 9511171 B2
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.
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.
2. The tissue implant of claim 1, 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.
3. The tissue implant of claim 2, 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.
4. The tissue implant of claim 3, wherein the tissue implant is incubated for a duration in the range of about 7 days to 6 weeks.
5. The tissue implant of claim 3, wherein the tissue implant is incubated at a temperature in the range of about 20 to 40° C. and under conditions of high humidity.
6. The tissue implant of claim 1, wherein the tissue implant further comprises at least one tissue fragment comprising tissue selected from the group consisting of 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.
7. The tissue implant of claim 6, wherein the at least one tissue fragment comprises autologous tissue.
8. The tissue implant of claim 1, 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.
9. The tissue implant of claim 1 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.
10. The tissue implant of claim 1, wherein the first scaffold further comprises a reinforcing component formed of a biocompatible mesh-containing material.
11. The tissue implant of claim 1, 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.
12. The tissue implant of claim 11, 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.
13. The tissue implant of claim 1, wherein the first bioimplantable scaffold comprises a polymeric foam component having pores with an open cell pore structure.
14. The tissue implant of claim 13 wherein the bioimplantable scaffold further comprises a reinforcing component formed of a biocompatible mesh-containing material.
15. The tissue implant of claim 1, wherein the first bioimplantable scaffold further comprises at least one additional biological component applied thereto.
16. The tissue implant of claim 15, 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.
17. The tissue implant of claim 9, 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.
18. The tissue implant of claim 17, 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.
19. The tissue implant of claim 18, 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; β-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.
20. The tissue implant of claim 1, wherein the tissue fragments have a size in the range of about 0.5 mm3 to about 1 mm3.
21. The tissue implant of claim 1, wherein the tissue fragments have a size in the range of about 1 mm3 to about 2 mm3.
22. The tissue implant of claim 1, wherein the tissue fragments have a size of about 1 mm3.
This application is a continuation of U.S. Ser. No. 10/374,772 filed on Feb. 25, 2003 and entitled “Biocompatible Scaffolds With Tissue Fragments” which claims priority to U.S. Provisional Patent Application No. 60/420,093 filed on Oct. 18, 2002 and entitled “Biocompatible Scaffold With Tissue Fragments,” and to U.S. Provisional Patent Application No. 60/419,539 filed on Oct. 18, 2002 and entitled “Biocompatible Scaffold for Ligament or Tendon Repair” all of which are incorporated by reference herein.
One common tissue injury involves damage to cartilage, which is a non-vascular, resilient, flexible connective tissue. Cartilage typically acts as a “shock-absorber” at articulating joints, but some types of cartilage provide support to tubular structures, such as for example, the larynx, air passages, and the ears. In general, cartilage tissue is comprised of cartilage cells, known as chondrocytes, located in an extracellular matrix, which contains collagen, a structural scaffold, and aggrecan, a space-filling proteoglycan. Several types of cartilage can be found in the body, including hyaline cartilage, fibrocartilage and elastic cartilage. Hyaline cartilage can appear in the body as distinct pieces, or alternatively, this type of cartilage can be found fused to the articular ends of bones. Hyaline cartilage is generally found in the body as articular cartilage, costal cartilage, and temporary cartilage (i.e., cartilage that is ultimately converted to bone through the process of ossification). Fibrocartilage is a transitional tissue that is typically located between tendon and bone, bone and bone, and/or hyaline cartilage and hyaline cartilage. Elastic cartilage, which contains elastic fibers distributed throughout the extracellular matrix, is typically found in the cpliglottis, the ears and the nose.
There is a continuing need in this art for novel surgical techniques for the surgical treatment of damaged tissue (e.g., cartilage, meniscal cartilage, ligaments, tendons and skin) that can effect a more reliable tissue repair and can facilitate the healing of injured tissue. Various surgical implants are known and have been used in surgical procedures to help achieve these benefits. For example, it is known to use various devices and techniques for creating implants having isolated cells loaded onto a delivery vehicle. Such cell-seeded implants are used in an in vitro method of making and/or repairing cartilage by growing cartilaginous structures that consist of chondrocytes seeded onto biodegradable, biocompatible fibrous polymeric matrices. Such methods require the initial isolation of chondrocytes from cartilaginous tissue prior to the chondrocytes being seeded onto the polymeric matrices. Other techniques for repairing damaged tissue employ implants having stem or progenitor cells that are used to produce the desired tissue. For example, it is known to use stem or progenitor cells, such as the cells within fatty tissue, muscle, or bone marrow, to regenerate bone and/or cartilage in a patient. The stem cells are removed from the patient and placed in an environment favorable to cartilage formation, thereby inducing the fatty tissue cells to proliferate and to create a different type of cell, such as for example, cartilage cells.
In one embodiment of the present invention, the scaffold can be formed from a biocompatible polymer. A variety of biocompatible polymers can be used to make the biocompatible tissue implants or scaffold devices according to the present invention. The biocompatible polymers can be synthetic polymers, natural polymers or combinations thereof. As used herein the term “synthetic polymer” refers to polymers that are not found in nature, even if the polymers are made from naturally occurring biomaterials. The term “natural polymer” refers to polymers that are naturally occurring. In embodiments where the scaffold includes at least one synthetic polymer, suitable biocompatible synthetic polymers can include polymers selected from the group consisting of aliphatic polyesters, poly(amino acids), poly(propylene fumarate), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, and blends thereof. Suitable synthetic polymers for use in the present invention can also include biosynthetic polymers based on sequences found in collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides and combinations thereof.
For the purpose of this invention aliphatic polyesters include, but are not limited to, homopolymers and copolymers of lactide (which includes lactic acid, D-, L- and meso lactide); glycolide (including glycolic acid); ε-caprolactone; 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; hydroxybutyrate; hydroxyvalerate; 1,4-dioxepan-2-one (including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione); 1,5-dioxepan-2-one; 6,6-dimethyl-1,4-dioxan-2-one; 2,5-diketomorpholine; 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; 6,6-dimethyl-dioxepan-2-one; 6,8-dioxabicycloctane-7-one and polymer blends thereof. Aliphatic polyesters used in the present invention can be homopolymers or copolymers (random, block, segmented, tapered blocks, graft, triblock, etc.) having a linear, branched or star structure. Poly(iminocarbonates), for the purpose of this invention, are understood to include those polymers as described by Kemnitzer and Kohn, in the Handbook of Biodegradable Polymers, edited by Domb, et. al., Hardwood Academic Press, pp. 251-272 (1997). Copoly(ether-esters), for the purpose of this invention, are understood to include those copolyester-ethers as described in the Journal of Biomaterials Research, Vol. 22, pages 993-1009, 1988 by Cohn and Younes, and in Polymer Preprints (ACS Division of Polymer Chemistry), Vol. 30(1), page 498, 1989 by Cohn (e.g., PEO/PLA). Polyalkylene oxalates, for the purpose of this invention, include those described in U.S. Pat. Nos. 4,208,511; 4,141,087; 4,130,639; 4,140,678; 4,105,034; and 4,205,399. Polyphosphazencs, co-, ter- and higher order mixed monomer based polymers made from L-lactide, D,L-lactide, lactic acid, glycolide, glycolic acid, para-dioxanone, trimethylene carbonate and ε-caprolactone such as are described by Allcock in The Encyclopedia of Polymer Science, Vol. 13, pages 31-41, Wiley Intersciences, John Wiley & Sons, 1988 and by Vandorpe, et al in the Handbook of Biodegradable Polymers, edited by Domb, et al., Hardwood Academic Press, pp. 161-182 (1997). Polyanhydrides include those derived from diacids of the form HOOC—C6H4—O—(CH2)m—O—C6H4—COOH, where “m” is an integer in the range of from 2 to 8, and copolymers thereof with aliphatic alpha-omega diacids of up to 12 carbons. Polyoxaesters, polyoxaamides and polyoxaesters containing amines and/or amido groups are described in one or more of the following U.S. Pat. Nos. 5,464,929; 5,595,751; 5,597,579; 5,607,687; 5,618,552; 5,620,698; 5,645,850; 5,648,088; 5,698,213; 5,700,583; and 5,859,150. Polyorthoesters such as those described by Heller in Handbook of Biodegradable Polymers, edited by Domb, et al., Hardwood Academic Press, pp. 99-118 (1997).
In another embodiment, the preferred scaffold for cartilage repair is a nonwoven structure. More preferably, the composition of the nonwoven structure are PANACRYL, a 95:5 copolymer of lactide and glycolidc, VICRYL, a 90:10 copolymer of glycolide and lactide, or a blend of polydioxanone and VICRYL sold under the tradename ETHISORB (Johnson & Johnson International, Belgium). For articular cartilage, the preferred structure to allow cell and tissue ingrowth is one that has an open pore structure and is sized to sufficiently allow cell migration. A suitable pore size for the nonwoven scaffold is one in which an average diameter is in the range of about 50 to 1000 microns and more preferably between about 100 to 500 microns. The nonwoven scaffold has a thickness between about 300 microns and 2 mm, and more preferably, between about 500 microns and 1.5 mm.
Preferably, the minced tissue has at least one viable cell that can migrate from the tissue fragment onto the scaffold. More preferably, the tissue contains an effective amount of cells that can migrate from the tissue fragment and begin populating the scaffold. In an optional embodiment, the minced tissue fragments may be contacted with a matrix-digesting enzyme to facilitate cell migration out of the extracellular matrix surrounding the cells. The enzymes are used to increase the rate of cell migration out of the extracellular matrix and into the scaffold material. Suitable matrix-digesting enzymes that can be used in the present invention include, but are not limited to, collagenase, chondroitinase, trypsin, elastase, hyaluronidase, petidasc, thermolysin and protease.
Healthy full-thickness skin samples, collected from 1×1 cm wounds created on the dorsal side of the pigs, were immediately placed in 50 ml conical tubes containing DMEM with 10× antibiotics/antimycotics. Tissue samples were rinsed once in PBS containing 10× antibiotic/antimycotics followed by an additional rinsing step with PBS containing 1× antibiotics/antimycotics. The tissue was minced aseptically using a scalpel blade in a laminar flow hood. Dispersed skin samples were subjected to enzymatic digestion with 1 ml of 0.25% collagenase/0.25% dispase at 37° C. for 15 min (Autologous cell dispersion #1). Another set of samples were first digested with 500 μl of 0.25% trypsin for 10 min, then washed with PBS to remove trypsin, and then incubated with 1 ml of 0.25% collagenase/0.25% dispase at 37° C. for 15 min (Autologous cell dispersion #2). Following digestion, the samples were centrifuged at 2500 rpm for 5 min. The supernatant was aspirated and discarded. Dispersed, partially digested skin samples were washed once in PBS and then re-suspended in 500 μA of PBS. Approximately 20 μl of cell suspension was distributed evenly in the wound bed and bioresorbable scaffold was carefully applied on the top of dispersed cells making sure not to dislodge the cell suspension. Dispersed cells could be distributed evenly on the scaffold and placed onto the wound bed. FIG. 4 demonstrates that autologous cell dispersion was present histologically as keratinocyte “islands,” some of which had migrated throughout the scaffold towards the wound surface.
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Clasificación internacional A61F2/10, A61F2/28, A61F2/00, A61L27/00, A61L27/36, A61F2/08, A61F2/30
Clasificación cooperativa A61L27/3817, A61F2/02, C12N5/0068, A61L27/3616, A61L27/3612, A61L2430/06, A61L27/36, A61L27/18, A61L27/58, A61L2430/34, A61L2400/18, A61F2310/0097, C12N5/0655, A61L27/3895, A61F2/08, A61L2430/10