Bioartificial pancreas

• US 5,674,289 A
• Filed: 01/06/1995
• Issued: 10/07/1997
• Est. Priority Date: 07/30/1992
• Status: Expired due to Fees

• Current Assignee: University of Toledo
• Original Assignee: University of Toledo
• Inventors: Sarver, Jeffrey G., Fournier, Ronald L., Goldblatt, Peter J., Horner, James M.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/369,708
• Time in Patent Office: 1,005 Days
• Field of Search: 604/4, 604/175, 623/11, 623/66, 210/192, 210/321.78, 210/321.79, 210/321.8, 210/321.87, 210/321.88, 210/321.89, 210/209, 210/198.1
• US Class Current: 623/23.64
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36

Abstract

An implantable bioartificial pancreas device having an islet chamber containing glucose responsive and insulin-secreting islets of Langerhans or similar hormone secreting cells, one or more vascularizing chambers open to surrounding tissue, a semi-permeable membrane between the islet and vascularizing chambers that allows passage of small molecules including insulin, oxygen and glucose and does not allow passage of agents of the immune system such as white cells and antibodies, the vascularizing chambers containing a growth factor soaked fibrous or foam matrix having a porosity of about 40 to 95%, the matrix providing small capillary growth and preventing the blood from clotting in the lower chamber.

Claims

1. A bioartificial pancreas for implantation into an animal comprising a device having an enclosed islet of Langerhans containing chamber and at least one vascularizing chamber having an opening on one end thereof that provides access to surrounding tissue, a plurality of insulin-secreting islets of Langerhans in the islet chamber, inlet means for supplying islets to the islet chamber, outlet means for removing islets to the islet chamber, a semi-permeable membrane between the islet and vascularizing chamber, the membrane providing immunoprotection of the islets from a vascular area within the vascularizing chamber and around the implanted device, the membrane having an average number molecular weight cut-off less than 100,000, allowing passage of small molecules including oxygen and insulin between the islet and vascularizing chambers and not allowing passage of agents of the immune system to the islet chamber, and a biocompatible fibrous or porous foam matrix in the vascularizing chamber to provide a neovascular formation region for enhancing the growth of small capillaries for providing efficient mass transfer of substances between the islet chamber and the capillaries in the vascularizing chamber, the fibrous or foam matrix having a porosity of about 40 to 95 percent and interconnecting passageways having an average pore size of about 10 to 120 microns, the fibers and foam being of an organic or inorganic material, the organic material composed principally of carbon, oxygen, and hydrogen atoms, the inorganic materials being composed of one or more of carbon, titanium, silica, sodium, calcium, strontium, magnesium, zinc and boron atoms.

2. A method of presenting insulin-secreting islets of Langerhans to the vascular system of an animal, including humans, the method comprising:

A. providing a bioartificial pancreas as defined in claim 1,

B. making the thickness of the bioartificial pancreas about 1 to 10 mm,

C. implanting the pancreas in a mammal; and

D. immunoisolating the implanted pancreas.

3. A method as defined in claim 2 in which the matrix thickness is about 2 to 3 mm and the matrix is keratin.

4. A method as defined in claim 2 in which the matrix thickness is about 2 to 3 mm and the matrix is polyethylene terephthalate.

5. A method as defined in claim 2 in which the matrix is a collagen.

6. A method as defined in claim 2 in which the implanting is done in the peritoneal cavity of an animal.

7. A method as defined in claim 2 in which the matrix is a polyurethane foam.

8. A method of providing metabolically active cells to the vascular system of a mammal, the method comprising:

A. providing a bioartificial organ for implantation into an animal comprising a housing having a first enclosed chamber containing metabolically active cells, at least one vascularizing chamber having an opening on one end thereof that provides access to surrounding tissue, inlet means for supplying cells to the first chamber, outlet means for removing cells from the first chamber, and a semi-permeable membrane separating and in communication with the first chamber and vascularizing chamber, the membrane providing immunoprotection of the active cells from a vascular area within the vascularizing chamber and around the implanted device, the membrane allowing passage of small molecules including nutrients and waste products between the first and vascularizing chambers and not allowing passage of agents of an immune system to the first chamber, and a biocompatible fibrous or porous foam matrix having fibers or foam in the vascularizing chamber to provide a neo vascular formation region for enhancing growth of small capillaries for providing efficient mass transfer of substances between first chamber and the capillaries in the vascularizing chamber, the fibrous or foam matrix having a porosity of about 40 to 95 percent and interconnecting passageways of about 10 to 120 microns, the fibers and foam being of an organic material or inorganic material, the organic material composed principally of carbon, oxygen, and hydrogen atoms, or sulfur atoms, oxygen atoms and nitrogen atoms, the inorganic materials being composed of at least one carbon, titanium, silica, sodium, calcium, strontium, magnesium, zinc and boron atoms, the first enclosed chamber including baffles means for assisting in even distribution of the metabolically active cells; and

B. implanting the organ in the mammal.

9. A method of providing metabolically active cells to the vascular system of a mammal, the method comprising:

A. providing a bioartificial organ for implantation into an animal comprising a housing having a first enclosed chamber containing metabolically active cells, at least one vascularizing chamber having an opening on one end thereof that provides access to surrounding tissue, inlet means for supplying cells to the first chamber, outlet means for removing cells from the first chamber, and a semi-permeable membrane separating and in communication with the first chamber and vascularizing chamber, the membrane providing immunoprotection of the active cells from a vascular area within the vascularizing chamber and around the implanted device, the membrane allowing passage of small molecules including nutrients and waste products between the first and vascularizing chambers and not allowing passage of agents of an immune system to the first chamber, and a biocompatible fibrous or porous foam matrix having fibers or foam in the vascularizing chamber to provide a neovascular formation region for enhancing growth of small capillaries for providing efficient mass transfer of substances between said first chamber and the capillaries in the vascularizing chamber, the fibrous or foam matrix having a porosity of about 40 to 95 percent and interconnecting passageways of about 10 to 120 microns, the fibers and foam being of an organic material or inorganic material, the organic material composed principally of carbon, oxygen, and hydrogen atoms, or sulfur atoms, oxygen atoms and nitrogen atoms, the inorganic materials being composed of at least one carbon, titanium, silica, sodium, calcium, strontium, magnesium, zinc and boron atoms, the first enclosed chamber including baffle means for assisting in even distribution of the metabolically active cells; and

B. implanting the organ in the mammal.

10. A method as defined in claim 9 in which the matrix is keratin.

11. A method as defined in claim 9 in which the matrix is a polyolefin.

12. A method as defined in claim 9 in which the matrix is polyurethane.

13. A method as defined in claim 9 in which the matrix is a glass.