Subcutaneous implantable multiple-agent delivery system

• US 5,391,164 A
• Filed: 03/01/1993
• Issued: 02/21/1995
• Est. Priority Date: 05/03/1991
• Status: Expired due to Fees

• Current Assignee: Vincent C. Giampapa
• Original Assignee: Tomagen Technologies, Inc.
• Inventors: Giampapa, Vincent C.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/024,426
• Time in Patent Office: 722 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 424/424, 424/425, 623/11
• US Class Current: 604/891.1
• 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: A61M 2039/0211 with multiple chambers in a single site
• 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
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

An implantable multiple-agent biologic delivery system includes a pod proportioned for subcutaneous implantation beneath the dermis of the skin, the pod including a porous surface and having at least one internal chamber which is in fluid communication with the porous surface. The system includes a dome proportioned for selectable detachable securement to the chamber of the pod. The dome includes interior chambers, each in fluid communication with the interior of the pod. Bio-acting agents, such as hormones, enzymes, biologic response modifiers, free radical scavengers, and genetically altered cell cultures, may be provided, within the chambers of the dome, prior to implantation. Such agents within the dome will, through the use of time release micropumps, enter the interior of the pod for transmission through the porous surfaces into a vascular growth factor stimulated capillary matrix and then to the bloodstream of the user. The pod may be removed, refilled, and resecured to the dome upon exhaustion of its contents or upon medical requirement for changes in medication, or may be percutaneously refilled in situ thru injection into the dome.

Claims

1. A subcutaneously implantable, bio-acting agent delivery system, comprising:

(a) a pod for subcutaneous implantation beneath the dermis of the human body, said pod comprising a porous surface between an interior and exterior of a bottom thereof and further comprising fluid transfer means in fluid communication with said porous surface, said pod having an opening at a top thereof, said pod formed of a biocompatible material, the exterior of the bottom of said pod provided with one or more biologically active materials to promote growth of blood capillaries into and about said porous surface;

(b) a removable dome proportioned for detachable securement about said opening of said pod, said dome including at least one chamber having selectable fluid communication with said fluid transfer means of said pod, in which bio-acting agents may be stored within said chamber of said dome prior to implantation, said dome formed of a biocompatible material; and

(c) programmable time dependent biologic agent release means within said chamber of said dome and in fluid communication with said fluid transfer means of said pod, whereby said agents are controllably released from said chamber of said dome and into said pod and, therefrom, through said porous surface into the bloodstream, in which said dome, after exhaustion of the agents therewithin, may be removed, refilled and resecured to said pod.

2. The system as recited in claim 1 in which said vascular growth factors are selected from the group of growth factors consisting essentially of vascular endothelial growth factor, platelet growth factor, vascular permeability factor, basic fibroblast growth factor and transforming growth factor beta.

3. The system as recited in claim 2 in which said pod is formed of a silastic material having a porous vascular ingrowth characteristic.

4. The system is recited in claim 2 in which said agent release means include piezoelectric micropump means within said at least one chamber of said dome.

5. The system as recited in claim 1 in which said programmable time dependent agent release means comprise micromechanical and microelectronic means.

6. The system as recited in claim 5 in which said vascular growth factors are also contained within a compartment of said dome.

7. The system as recited in claim 5 in which said fluid transfer means comprise capillary means.

8. The system is recited in claim 7 in which said dome includes at least one septum by which the at least one chamber in said dome can be re-filled in situ by percutaneous injection.

9. The system is recited in claim 8 in which control means for said agent release means are situated within an axial central core and in said dome.

10. The system as recited in claim 5 in which control means for said agent release means are situated within an axial central core in said dome.

11. The system is recited in claim 10 in which said vascular growth factors are selected from the group of growth factors consisting essentially of vascular endothelial growth factor, platelet growth factor, vascular permeability factor, basic fibroblast growth factor and transforming growth factor beta.

12. The system as recited in claim 1 in which said pod is formed of a silastic material having a porous vascular ingrowth characteristic.

13. The system as recited in claim 12 in which said silastic material is selected from the group consisting of silicone and polytetrafiuorethylene.

14. The system as recited in claim 12 in which said fluid transfer means comprise capillary means.