Methods and Compositions for Enhancing Vascular Access
First Claim
1. A method for treating a vascular access structure in a patient, the method comprising the step of locating at, adjacent or in the vicinity of the vascular access structure in said patient an implantable material comprising cells and a biocompatible matrix, wherein the implantable material is effective to promote functionality of said structure.
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Accused Products
Abstract
Disclosed is an implantable material comprising a biocompatible matrix and cells which, when provided to a vascular access structure, can promote functionality generally. For example, implantable material of the present invention can enhance maturation of an arteriovenous native fistula as well as prolong the fistula in a mature, functional state suitable for dialysis. Additionally, the present invention can promote formation of a functional arteriovenous graft suitable for dialysis as well as promote formation of a functional peripheral bypass graft. Implantable material can be configured as a flexible planar form or a flowable composition with shape-retaining properties suitable for implantation at, adjacent or in the vicinity of an anastomoses or arteriovenous graft. According to the methods disclosed herein, the implantable material is provided to an exterior surface of a blood vessel. Certain embodiments of the flexible planar form define a slot. The materials and methods of the present invention comprise cells, preferably endothelial cells or cells having an endothelial-like phenotype.
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Citations
147 Claims
- 1. A method for treating a vascular access structure in a patient, the method comprising the step of locating at, adjacent or in the vicinity of the vascular access structure in said patient an implantable material comprising cells and a biocompatible matrix, wherein the implantable material is effective to promote functionality of said structure.
- 23. A method for enhancing maturation of an arteriovenous fistula in a human, the method comprising the step of locating at, adjacent or in the vicinity of the fistula an implantable material comprising a biocompatible matrix and cells wherein the implantable material is effective to enhance maturation of the fistula.
- 30. A method for preventing an arteriovenous fistula from failing to mature in a human, the method comprising the step of locating a biocompatible matrix comprising engrafted vascular endothelial cells at, adjacent or in the vicinity of the fistula in the human thereby to prevent a fistula from failing to mature.
- 47. A method of maintaining a blood flow rate of an arteriovenous graft, the method comprising the step of providing an implantable material comprising cells and a biocompatible matrix wherein said implantable material is disposed on an exterior surface of said arteriovenous graft at, adjacent or in the vicinity of a prosthetic bridge of a venous outflow region of said arteriovenous graft in an amount effective to maintain blood flow rate of the graft.
- 49. A method of maintaining normal blood flow of a peripheral bypass graft sufficient to maintain peripheral circulation, the method comprising the step of providing an implantable material comprising cells and a biocompatible matrix wherein said implantable material is disposed on an exterior surface of said bypass graft at, adjacent or in the vicinity of a prosthetic bridge in an amount effective to maintain blood flow rates of the bypass graft sufficient to maintain peripheral circulation.
- 51. A method of promoting tissue integration of a prosthetic bridge of an arteriovenous graft or a peripheral bypass graft, the method comprising the step of providing an implantable material comprising cells and a biocompatible matrix wherein said implantable material is disposed on an exterior surface of said arteriovenous graft or said peripheral bypass graft at, adjacent or in the vicinity of a prosthetic bridge in an amount effective to promote tissue integration of said bridge.
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54. A method of preventing or reducing the incidence of dehiscence of an arteriovenous fistula or arteriovenous graft, the method comprising the step of providing an implantable material comprising cells and a biocompatible matrix wherein said implantable material is disposed on an exterior surface of said fistula or arteriovenous graft at, adjacent or in the vicinity of a prosthetic bridge of a venous outflow region of said arteriovenous graft in an amount effective to prevent or reduce the incidence of dehiscence.
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57. An implantable material comprising:
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(a) cells; and
,(b) a biocompatible matrix; wherein said implantable material is disposed in the vicinity of, adjacent or contacting a prosthetic bridge; and wherein said prosthetic bridge is situated at or near a venous outflow region of an arteriovenous graft or is situated at or near an outflow of a peripheral bypass graft.
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- 58. A method of maintaining a blood pressure of an arteriovenous graft sufficient to permit dialysis, the method comprising the step of providing an implantable material comprising cells and a biocompatible matrix wherein said implantable material is disposed on an exterior surface of said arteriovenous graft at, adjacent or in the vicinity of a prosthetic bridge of a venous outflow region of said arteriovenous graft in an amount effective to maintain blood pressure sufficient to permit dialysis.
- 71. A transport media composition for storing an implantable material comprising a biocompatible matrix and engrafted cells, said transport media composition comprising an amount of VEGF sufficient to maintain cell viability or an inhibitory phenotype, wherein the cells remain viable for an extended period of time when stored in said transport media composition at temperatures below the cells'"'"' standard cell culture temperature.
- 82. A cryopreservation media composition for cryopreserving an implantable material comprising a biocompatible matrix and engrafted cells, said cryopreservation media composition comprising a cryopreservative, a polysaccharide and serum, wherein cell viability or an inhibitory phenotype and matrix integrity are maintained for an extended period of time when stored at least about −
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99. A cryopreserved implantable material comprising a biocompatible matrix engrafted with cells and a volume of cryopreservation media composition sufficient to maintain cell viability or an inhibitory phenotype and matrix integrity while cryopreserved, wherein said cryopreservation media composition comprises a cryopreservative, a polysaccharide and serum.
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100. A method for storing an implantable material comprising a biocompatible matrix and engrafted cells for an extended period of time at a temperature below the cells'"'"' standard cell culture temperature, said method comprising the steps of:
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bathing the implantable material in a transport media composition comprising an amount of VEGF sufficient to maintain cell viability or an inhibitory phenotype during storage, wherein the cells remain viable or maintain an inhibitory phenotype for an extended period of time when stored in said transport media composition at a temperature below the cells'"'"' standard cell culture temperature. - View Dependent Claims (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113)
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114. A method for cryopreserving an implantable material comprising a biocompatible matrix and engrafted cells for an extended period of time at a temperature about −
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C., said method comprising the steps of;bathing the implantable material in a cryopreservation media composition comprising a cryopreservative, a polysaccharide and serum, wherein the cells remain viable or maintain an inhibitory phenotype and the matrix remains intact for an extended period of time when stored in said cryopreservation media composition at a temperature about −
4°
C. - View Dependent Claims (115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132)
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133. A method of preparing an implantable material comprising a biocompatible matrix and engrafted cells, said method comprising the steps of:
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preparing a working cell bank; providing a hydrated biocompatible matrix material; seeding the hydrated biocompatible matrix material with cells from the working cell bank; placing the cell seeded biocompatible matrix material in an incubator to facilitate cell attachment; placing the cell seeded biocompatible matrix material in an incubator until the cells are near-confluent, confluent, or post-confluent; and assessing cell count, cell viability and/or cell functionality of the cell seeded biocompatible matrix material. - View Dependent Claims (134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144)
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145. A method of manufacturing an implantable material comprising cells and a biocompatible matrix, said method comprising the step of:
contacting said biocompatible matrix with said cells using reagents and conditions suitable therefor, wherein said cells are in an amount sufficient to populate said matrix and grow to a confluent, near-confluent or post-confluent population and further wherein said matrix is populated with cell typing-independent, non-compatibility tested, non-matched cells. - View Dependent Claims (146, 147)
Specification