Implantable delivery system for biological factors

• US 5,011,472 A
• Filed: 10/06/1988
• Issued: 04/30/1991
• Est. Priority Date: 09/06/1988
• Status: Expired due to Term

• Current Assignee: Brown University, Neurotech S.A. (LivaNova Plc)
• Original Assignee: Brown University
• Inventors: Miracoli, Luigi, Panol, George, Aebischer, Patrick, Galletti, Pierre M.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/240,939
• Time in Patent Office: 936 Days
• Field of Search: 604/50, 604/52, 604/53, 604/153, 604/246, 604/890.1, 604/891.1, 604/892.1, 604/6, 604/5, 604/4, 623/12
• US Class Current: 604/892.1
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

Devices and methods are disclosed to provide hybrid, modular systems for the constitutive delivery of appropriate dosages of active factor to a subject and, in some instances, to specific anatomical regions of the subject. The systems include a cell reservoir containing living cells capable of secreting an active agent, which is preferably adapted for implantation within the body of the subject and further includes at least one semipermeable membrane, whereby the transplanted cells can be nourished by nutrients transported across the membrane while at the same time protected from immunological, bacterial, and viral assault. The systems further include a pumping means, which can be implantable or extracorporeal, for drawing a body fluid from the subject into the cell reservoir and for actively transporting the secreted biological factors from the cell reservoir to a selected region of the subject.

Claims

1. A delivery device for delivering a biologically active factor to a subject, the device comprising:

a cell reservoir means for receiving at least one active, factor-secreting cell, said means including a chamber having at least one semipermeable membrane, said membrane adapted to be held in contact with a source of body fluid for introducing body fluid into said reservoir means; and

pumping means for transporting a secreted active factor from said reservoir means to a selected region in a subject, whereby at least one active, factor-secreting cell is located within said reservoir means for secreting an active factor, which active factor is carried to said selected region via body fluid introduced into said reservoir through said membrane.

2. The device of claim 1 wherein at least a portion of the device is adapted for implantation within the subject, and the pumping means further includes means for convectively drawing a body fluid from the subject into the cell reservoir.

3. The device of claim 1 wherein said semipermeable membrane of said cell reservoir is a tubular membrane.

4. The device of claim 1 wherein said semipermeable membrane of said cell reservoir is a material selected from the group consisting of acrylic copolymers, polyurethane isocyanates, cellulose acetate, polyalginate, polysulfone, polyvinyl alcohols, polyvinylidene fluoride, polyacryl nitriles, and derivatives and mixtures thereof.

5. The device of claim 1 wherein said semipermeable membrane of said cell reservoir is a porous material, allowing the passage therethrough of molecules with a molecular weight of up to about 100,000 daltons.

6. The device of claim 1 wherein said semipermeable membrane of said cell reservoir is a porous material allowing the passage therethrough of molecules with a molecular weight of up to about 50,000 daltons.

7. The device of claim 1 wherein the device further includes a catheter connected to said pumping means and in fluid communication therewith to transport said active factor to said selected region in said patient.

8. The device of claim 7 wherein the catheter further includes a biocompatible coating.

9. The device of claim 8 wherein the catheter further includes a biocompatible turbostratic carbon coating.

10. The device of claim 1 wherein the device further includes a controller electronically coupled to said pumping means to control fluid transport through said pumping means.

11. The device of claim 1 wherein said device further includes a back-up supply cartridge containing said active factor,

said back-up supply cartridge being in fluid communication with said pumping means, and responsive thereto for delivery of said active factor to said selected region of said subject.

12. A delivery device for delivering a biologically active factor to a selected region in a living subject, the device comprising:

a cell reservoir means for receiving at least one active, factor-secreting cell, including a chamber having at least one semipermeable membrane,

said membrane comprising means for permeation into said reservoir means of selected body fluid from a source of body fluid and means for permeation of a portion of said selected body fluid out of said reservoir along with an active factor secreted by said at least one cell, and

pump means for transporting said selected body fluid,

whereby at least one active, factor-secreting cell is located within said reservoir means for secreting an active factor, which active factor is transported by said transported selected body fluid for delivery to a selected region in the living subject.