Implantable system for cell growth control

• US 7,037,304 B2
• Filed: 09/24/2001
• Issued: 05/02/2006
• Est. Priority Date: 07/02/1993
• Status: Expired due to Fees

• Current Assignee: Materials Evolution and Development USA Incorporated
• Original Assignee: Materials Evolution and Development USA Incorporated
• Inventors: Lyles, Mark B., Mallow, William A., Halff, Glenn A., McLaughlin, Charles A.
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US09/961,479
• Publication Number:
  US 20020120251A1
• Time in Patent Office: 1,681 Days
• Field of Search: 604/891.1, 424/422, 424/423, 424/425, 623/1.1, 623/11.11, 623/1.42, 623/1.43, 623/1.54, 435/180
• 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 drug delivery system comprising:

a porous linked fibrous substantially non-biodegradable biomaterial, the biomaterial having a plurality of voids of at least one predetermined size range; and

at least one drug dispersed within the voids of the biomaterial;

wherein at least a selected portion of the voids have a predetermined size range effective to stimulate angiogenesis when the system is implanted in bone or vascular tissue, and the biomaterial consists of nonwoven, randomly-oriented fibers linked together at a variety of cross-points.

2. The system on claim 1, further comprising the biomaterial having a plurality of voids of at least two predetermined size ranges, wherein at least a first selected portion of the voids have a predetermined size range effective to stimulate angiogenesis when the system is implanted in bone or vascular tissue, and wherein at least a second portion of the voids have a predetermined size range effective to release the drug at a calculated rate when the system in implanted in bone or vascular tissue.

3. The system of claim 1, wherein the predetermined size range of the plurality of voids is between approximately 100 and 1000 microns in diameter.

4. The system of claim 1, further comprising the biomaterial having a plurality of voids of at least one predetermined mean void space.

5. The system of claim 1, further comprising the drug dispersed within a biodegradable matrix.

6. The system of claim 5, wherein the biodegradable matrix comprises a material selected from the group consisting of:

polyparadioxanon, polylysine, polyglycolic acid, polylactic acid, homopolymers thereof, copolymers thereof, and combinations thereof.

7. The system of claim 5, wherein the bioegradable matrix is augmented with a material selected from the group consisting of:

GLASSFIBER plaster of Paris, beta-whitlockite, hydroxyapatite, calcium phosphate ceramics, and combinations thereof.

8. The system of claim 5, wherein the biodegradable matrix is operable to control release of the drug when the system is implanted in bone or vascular tissue.

9. The system of claim 1, wherein the drug comprises an antibiotic.

10. The system of claim 1, wherein the drug comprises a synthetic or natural hormone.

11. The system of claim 1, wherein the system is implanted in the vasculature of an animal.

12. The system of claim 1, wherein the system is implanted in the bone of an animal.