Bioartificial pancreas

• US 5,387,237 A
• Filed: 07/21/1993
• Issued: 02/07/1995
• Est. Priority Date: 07/30/1992
• Status: Expired due to Term

• Current Assignee: Medical College of Ohio
• Original Assignee: University of Toledo
• Inventors: Sarver, Jeffrey G., Fournier, Ronald L., Goldblatt, Peter J., Horner, James M.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): BURKE, ELIZABETH
• Application Number:
  US08/094,946
• Time in Patent Office: 566 Days
• Field of Search: 604/4, 604/175, 623/11, 623/12, 424/424, 435/283, 435/284, 210/321.6, 210/321.87, 210/321.9
• 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, the islet chamber having baffle means inside thereof to assist in even distribution of the islets in the chamber, 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 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 the 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 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 hydrogen atoms, or carbon atoms, oxygen atoms, hydrogen atoms and nitrogen atoms, the inorganic materials being composed of at least one of carbon, titanium, silica, sodium, calcium, strontium, magnesium, zinc and boron atoms, there being baffle means in the first enclosed chamber for assisting in even distribution of the metabolically active cells.

2. A bioartificial organ as defined in claim 1 in which the baffle means is a baffle plate in the first chamber.

3. A bioartificial organ as defined in claim 1 in which the baffle means is three baffle plates generally parallel to each other to provide even distribution of the cells in the first chamber.

4. An organ as defined in claim 3 in which there are three baffle plates.

5. A bioartificial organ as defined in claim 1 in which the baffle means is spiral-shaped coil forming a labyrinth inside the first chamber to assist in even distribution of the cells.

6. A bioartificial implantable pancreas comprising a housing having a first enclosed chamber containing islets of Langerhans, 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 first chamber, inlet means for supplying islets to the first chamber, outlet means for removing islets from the first chamber, a semi-permeable membrane between the first islet chamber and vascularizing chamber, the membrane providing immunoprotection of the islets from the vascular area within the vascularizing chamber and around the implanted device, the membrane allowing passage of small molecules including oxygen and insulin between the first and vascularizing chambers and not allowing passage of agents of the 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 the growth of small capillaries for providing efficient mass transfer of nutrients, glucose, oxygen, and insulin between in the islet chamber and the blood stream 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 200 microns, the fibers and foam being of an organic or inorganic material, the organic material composed principally of carbon, oxygen, and hydrogen atoms and optionally, nitrogen and sulfur atoms, the inorganic materials being composed of at least one of carbon, titanium, silica, sodium, calcium, strontium, magnesium, zinc and boron atoms, and there being baffle means inside the first chamber to assist in providing an even distribution of the islet cells in the first chamber.

7. 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 the 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 and 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 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 or inorganic material, the organic material composed principally of carbon, oxygen, and hydrogen atoms and optionally, nitrogen and sulfur atoms, the inorganic materials being composed of at least one of carbon, titanium, silica, sodium, calcium, strontium, magnesium, zinc and boron atoms, the first active cell containing chamber being a longitudinally extending hollow fiber.

8. An organ as defined in claim 7 in which cell containing chamber is coiled helically-shaped hollow fiber.

9. An organ as defined in claim 7 in which there are a plurality of parallel hollow fibers, each inlet means and outlet means of the fibers being connected to a common feed source and a common exit source.