Implantable bioartificial perfusion system

• US 9,814,829 B2
• Filed: 06/29/2015
• Issued: 11/14/2017
• Est. Priority Date: 04/27/2012
• Status: Active Grant

• Current Assignee: Gregory Zeltser, Michael Piliavin
• Original Assignee: Gregory Zeltser, Michael Piliavin
• Inventors: Zeltser, Gregory, Piliavin, Michael
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US14/753,554
• Publication Number:
  US 20150297828A1
• Time in Patent Office: 869 Days
• 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 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2210/1021 Abdominal cavity
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

The disclosure provides an implantable bioartificial active secretion system for providing a physiological regulating secretion such as insulin necessary for functionality of a physiologic activity such as glucose metabolism of a living-being host. The system includes a housing implantable within the host, in fluidic communication with tissue fluid indicative of a physiological regulating secretion need. A chamber within the housing contains a plurality of physiologically active, autonomously functioning, live secretory cells for producing the physiological regulating secretion. A continually operating two pump apparatus moves tissue fluid into contact with the secretory cells for pick up of the physiological regulating secretion for subsequent physiologically-effective dispensing into the host, while avoiding immuno-rejection of the host body or of the host to the secretory cells.

Claims

1. An implantable bioartificial perfusion system for providing a physiological regulating secretion necessary for functionality of a physiologic activity of a living-being host, the system comprising:

a) a housing having an inlet with an external opening thereto and an outlet with an external opening therefrom, the housing implantable at least partially within the host such that the inlet and outlet openings are positionable in fluidic communication with tissue fluid of the host for receiving into and dispensing from the housing the tissue fluid;

b) a chamber disposed within the housing between the inlet and outlet and in communication therewith, the chamber having a plurality of scaffolds having three-dimensional porous matrices with polymer microsphere spacers coated with extracellular matrix (ECM) molecules there between, wherein a plurality of physiologically active, autonomously and in concert functioning, live secretory cells for producing the physiological regulating secretion are disbursed among the porous matrices throughout the chamber, wherein the matrices are coated with autologous or allogeneic extracellular matrix (ECM) molecules and seeded with a plurality of ECM cells comprising fibroblasts and macrophages, and wherein layers of each matrix are kept at a certain distance from each other by the polymer microsphere spacers;

c) a constantly operating two pump apparatus for drawing initial tissue fluid through the inlet from the host for contact with the physiologically active cells within the chamber for pick up of the physiological regulating secretion, and for dispensing resulting tissue fluid bearing the physiological regulating secretion through the outlet and into the host; and

d) an inlet filter in operational communication with the external opening of the inlet and disposed upstream of the chamber, wherein the inlet filter comprises a plurality of mesh woven polymer yarn to collect peritoneal fluid from a high surface area of the parietal peritoneum and visceral peritoneum by means of capillary forces and a size-exclusion membrane filter separated from the plurality of mesh woven polymer yarn by a capillary gap for prohibiting passage into the chamber of immune system cells of the host.

2. The implantable bioartificial perfusion system of claim 1, wherein the two pump apparatus is located upstream and downstream from the chamber, and wherein the two pump apparatus uses electromagnetic, osmotic, or electro-osmotic force.

3. The implantable bioartificial perfusion system of claim 1, further comprising an outlet filter in operational communication with the external opening of the outlet and disposed downstream of the chamber, wherein the outlet filter comprises pores therethrough sized for prohibiting passage into the chamber of immune system cells of the host.

4. An implantable bioartificial perfusion system for providing a physiological regulating secretion necessary for functionality of a physiologic activity of a living-being host, the system comprising:

a) a housing having an inlet with an external opening thereto and an outlet with an external opening therefrom, the housing implantable at least partially within the host such that the inlet and outlet openings are positionable in fluidic communication with peritoneal fluid within a peritoneal cavity of the host for receiving into and dispensing from the housing the peritoneal fluid;

b) a chamber disposed within the housing between the inlet and outlet and in communication therewith, the chamber having a plurality of scaffolds having three-dimensional porous matrices with polymer microsphere spacers coated with extracellular matrix (ECM) molecules there between, wherein a plurality of physiologically active, autonomously and in concert functioning, live secretory cells for producing the physiological regulating secretion are disbursed among the porous matrices throughout the chamber, wherein the matrices are coated with autologous or allogeneic extracellular matrix (ECM) molecules and seeded with a plurality of ECM cells comprising fibroblasts and macrophages, and wherein layers of each matrix are kept at a certain distance from each other by the polymer microsphere spacers;

c) a constantly operating two pump apparatus disposed for drawing initial peritoneal fluid through the inlet from the peritoneal cavity for contact with the physiologically active cells within the chamber for pick up of the physiological regulating secretion, and for dispensing resulting peritoneal fluid bearing the physiological regulating secretion through the outlet and into the peritoneal cavity; and

d) an inlet filter in operational communication with the external opening of the inlet and disposed upstream of the chamber, wherein the inlet filter comprises a tissue fluid sucking filter comprising a plurality of mesh woven polymer yarn and a size-exclusion membrane filter separated from each other by a capillary gap for peritoneal or other tissue fluid collection, filtration and prohibiting passage into the chamber of immune system agents and cells, immunoglobulins, and complement system components of the host.

5. The implantable bioartificial perfusion system of claim 4, wherein the two pump apparatus is located upstream and downstream from the chamber, and wherein the two pump apparatus uses electromagnetic, osmotic, or electro-osmotic force.

6. The implantable bioartificial perfusion system of claim 4, further comprising an outlet filter in operational communication with the external opening of the outlet and disposed downstream of the chamber, the outlet filter having pores therethrough sized for prohibiting passage into the chamber of immune system agents, cells, immunoglobulins, and complement system components of the host.

7. An implantable bioartificial perfusion system for providing insulin as necessary for the metabolism of glucose within a living-being host, the system comprising:

a) a housing having an inlet with an external opening thereto and an outlet with an external opening therefrom, the housing implantable at least partially within the host such that the inlet and outlet openings are positionable in fluidic communication with tissue fluid of the host for receiving into and dispensing from the housing the tissue fluid;

b) a chamber disposed within the housing between the inlet and outlet and in communication therewith, the chamber having a plurality of scaffolds having three-dimensional porous matrices with polymer microsphere spacers coated with extracellular matrix (ECM) molecules there between, wherein a plurality of physiologically active, autonomously and in concert functioning, live secretory cells for producing insulin are disbursed among the porous matrices throughout the chamber, wherein the matrices are coated with autologous or allogeneic extracellular matrix (ECM) molecules and seeded with a plurality of ECM cells comprising fibroblasts and macrophages, and wherein layers of each matrix are kept at a certain distance from each other by the polymer microsphere spacers;

c) a constantly operating two pump apparatus for drawing initial tissue fluid through the inlet from the host for contact with the physiologically active cells within the chamber for pick up of insulin, and for dispensing the resulting tissue fluid bearing the insulin through the outlet and into the host; and

d) an inlet filter in operational communication with the external opening of the inlet and disposed upstream of the chamber, the inlet filter comprising a tissue fluid sucking filter comprising a plurality of mesh woven polymer yarn and a size-exclusion membrane filter separated from each other by a capillary gap for peritoneal or other tissue fluid collection, filtration and prohibiting passage into the chamber of immune system agents and cells, immunoglobulins, and complement system components of the host.

8. The implantable bioartificial perfusion system of claim 7, wherein the two pump apparatus is located upstream and downstream from the chamber, and wherein the two pump apparatus uses electromagnetic, osmotic, or electro-osmotic force.

9. The implantable bioartificial perfusion system of claim 7, further comprising an outlet nanoporous membrane filter in operational communication with the external opening of the outlet and disposed downstream of the chamber, the outlet nanoporous membrane filter having pores therethrough sized for prohibiting passage into the chamber of immune system cells, immunoglobulins, and complement system components of the host.