Implantable biocompatible immunoisolatory vehicle for the delivery of selected therapeutic products

• US 6,322,804 B1
• Filed: 05/02/2000
• Issued: 11/27/2001
• Est. Priority Date: 04/25/1991
• Status: Expired due to Fees

• Current Assignee: Neurotech S.A. (LivaNova Plc)
• Original Assignee: Neurotech S.A. (LivaNova Plc)
• Inventors: Dionne, Keith E., Lysaght, Michael J., Gentile, Frank T., Christenson, Lisa, Scharp, David W., Hegre, Orion D., Hoffman, Diane, Lacy, Paul E., Emerich, Dwaine F., Aebischer, Patrick, Sanberg, Paul R., Vasconcellos, Alfred V.
• Primary Examiner(s): Bawa, Raj
• Application Number:
  US09/563,248
• Time in Patent Office: 574 Days
• Field of Search: 424/422, 424/423, 424/424, 424/426, 424/430, 424/434, 424/437, 424/489, 424/490, 514/866, 514/814, 514/2
• US Class Current: 424/422
• CPC Class Codes: A61K 2035/126 Immunoprotecting barriers, e.g. jackets, diffusion chambers
• CPC Class Codes: A61K 2035/128 capsules, e.g. microcapsules
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 35/30 Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
• CPC Class Codes: A61K 35/39 Pancreas; Islets of Langerhans Langerhans cells of epidermis A61K35/36
• CPC Class Codes: A61K 38/185 Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• 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: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 37/02 Immunomodulators
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/24 of the sex hormones
• CPC Class Codes: C12N 2510/02 : Cells for production
• CPC Class Codes: C12N 5/0012 : Cell encapsulation
• CPC Class Codes: C12N 5/0062 : General methods for three-dimensional culture
• CPC Class Codes: C12N 5/0614 : Adrenal gland
• CPC Class Codes: C12N 5/0656 : Adult fibroblasts
• CPC Class Codes: C12N 5/0677 : Three-dimensional culture, tissue culture or organ culture; Encapsulated cells

Abstract

An immunoisolatory vehicle for the implantation into an individual of cells which produce a needed product or provide a needed metabolic function. The vehicle is comprised of a core region containing isolated cells and materials sufficient to maintain the cells, and a permselective, biocompatible, peripheral region free of the isolated cells, which immunoisolates the core yet provides for the delivery of the secreted product or metabolic function to the individual.

Claims

1. An implantable immunoisolatory vehicle for providing a biologically active product or function to an individual, the immunoisolatory vehicle comprising:

(a) a core comprising at least 10⁴ living cells, said cells being capable of secreting a selected biologically active product or of providing a selected biological function to an individual, wherein said core is designed to maintain the viability and function of the living cells and said cells within said core having a maximum depth-to-surface distance of 2 mm in at least one dimension; and

(b) an external diffusional surface jacket having a thickness of 5 to 200 microns surrounding said core formed of a biocompatible material free of said cells projecting externally thereof, said jacket having a molecular weight cutoff below the molecular weight of substances essential for immunological rejection of the cells but permitting passage of substances between the individual and core through said jacket required to provide said biological product or function.

2. The implantable immunoisolatory vehicle according to claim 1 wherein the biocompatible material is a hydrogel or polymer.

3. The implantable immunoisolatory vehicle according to claim 2 wherein the polymer is a thermoplastic polymer.

4. The implantable immunoisolatory vehicle according to claim 3 wherein the thermoplastic polymer is polyacrilonitrile/polyvinylchloride.

5. The implantable immunoisolatory vehicle according to claim 1 wherein the maximum depth-to-surface distance is 800 μ

m .