Implantable system for cell growth control

• US 5,964,745 A
• Filed: 03/18/1996
• Issued: 10/12/1999
• Est. Priority Date: 07/02/1993
• Status: Expired due to Fees

• Current Assignee: US MED (VINCI SA)
• Original Assignee: US MED (VINCI SA)
• Inventors: McLaughlin, Charles A., Lyles, Mark B., Mallow, William A., Halff, Glenn A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/569,107
• Time in Patent Office: 1,303 Days
• Field of Search: 604/891.1, 424/422, 424/423, 424/425, 623/1, 623/11
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 27/105 containing Al2O3
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/028 Other inorganic materials not covered by A61L31/022 - A61L31/026
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

An implantable infection shield and system for drug delivery in vascular tissue includes a relatively non-biodegradable porous linked fibrous biomaterial which controls and directs cell growth and angiogenesis from adjacent vascular tissue into the implant. Infection shield embodiments stimulate cell growth and angiogenesis from adjacent vascular tissue which effectively blocks passage of pathogenic microorganisms along percutaneously implanted objects. In embodiments for drug delivery, a reservoir of the same biomaterial may contain either (1) a cell culture system enclosed within a porous sealable interior chamber or (2) a biodegradable matrix in which one or more drugs are dispersed. After implantation of a reservoir of the first embodiment in an organism, cultured cells obtain food and oxygen via diffusion in tissue fluid through the porous walls of the interior chamber, while metabolic products, including drugs, diffuse away from the cell culture in an analogous manner. In a reservoir of the second embodiment, a biodegradable matrix substantially fills the pores (voids), and progressive dissolution of the matrix releases one or more drugs into surrounding tissue fluid. Reservoirs of either embodiment comprise a plurality of voids of a predetermined size effective for stimulating angiogenesis from the surrounding vascular tissue into at least a portion of the reservoir. The reservoir thus acts to couple a source of drugs to the circulatory system of the organism.

Claims

1. An implantable system for growth for insertion into bone or vascular tissue;

said implantable system comprising porous linked fibrous biomaterial manufactured from nonwoven, randomly-oriented fibers linked together using a fusion source at a plurality of cross-points into a porous structure, said biomaterial having a plurality of voids of a predetermined mean void size effective for stimulating angiogenesis in said biomaterial from the tissue or bone.

2. The implantable system of claim 1 additionally comprising

a biodegradable matrix dispersed within said voids;

and

at least one drug dispersed within said matrix.

3. The implantable system of claim 1 wherein the biomaterial is a ceramic.

4. A reservoir for coupling a cell culture to vascular tissue in which the reservoir may be implanted, the reservoir comprising

a sealable interior chamber for containing a cell culture, said chamber having a porous wall, said wall comprising linked fibrous biomaterial having a plurality of voids of a predetermined mean void size effective for inhibiting angiogenesis in said wall from the vascular tissue;

and

a porous linked fibrous biomaterial outer coat having a plurality of voids of a predetermined mean void size effective for stimulating angiogenesis in said reservoir from the vascular tissue, said outer coat substantially completely surrounding said sealable interior chamber wall.

5. A method for making a system for drug delivery for implantation in vascular tissue, the method comprising

obtaining a reservoir comprising porous linked fibrous biomaterial manufactured from nonwoven, randomly-oriented fibers linked together using a fusion source at a plurality of crossing points into a porous structure, said biomaterial having a plurality of voids of a predetermined mean void size effective for stimulating angiogenesis in said reservoir from the vascular tissue;

providing a biodegradable matrix;

dispersing a drug to be delivered in said biodegradable matrix to form a drug delivery matrix; and

dispersing said drug delivery matrix within said voids to make a system for drug delivery.

6. An infection shield for a catheter intended for placement through skin and subcutaneous tissue, the shield comprising

a substantially cylindrically shaped catheter seal for substantially circumferentially surrounding the catheter, the seal comprising porous linked fibrous biomaterial having a plurality of voids of a predetermined mean void size effective for inhibiting angiogenesis from the skin and subcutaneous tissue;

and

a tissue cuff circumferentially surrounding said catheter seal, said cuff comprising porous linked fibrous biomaterial having a plurality of voids of a predetermined mean void size effective for stimulating angiogenesis in said cuff from the skin and subcutaneous tissue.

7. The infection shield of claim 6 wherein said fibrous biomaterial comprises silica.