Claims for Patent: 9,393,351

Summary for Patent: 9,393,351

Title:	Cloned biological material medical device and method thereof
Abstract:	A medical device, said medical device, comprises: a first component having a non-biological material; a second component having a cloned biological material, said second component being attached to said first component, wherein said first component and said second component are operatively associated in a non-living medical device for at least one of treatment, diagnosis, cure, mitigation and prevention of disease, injury, handicap or condition in a living organism. In another aspect, a method comprises: preparing a cloned biological material from a tissue or an organ; attaching said biological material to a medical device; interfacing said biological material with the non-biological material; providing treatment, diagnosis, cure, mitigation and prevention of disease, injury, handicap or condition in a living organism.
Inventor(s):	Raniere; Keith A (Clifton Park, NY)
Assignee:	FIRST PRINCIPLES, INC. (Albany, NY)
Application Number:	14/034,977
Patent Claims:	1. A method for reducing or preventing immune reactions resulting from contact with a non-living medical device comprising: preparing a cloned biological material from a tissue or an organ, the cloned biological material being at least one of a shaped tissue structure of desired cells and a shaped organ structure of desired cells, wherein preparing the cloned biological material includes removing a portion of the tissue or the organ from a living organism, further wherein removing the portion of the tissue or the organ from the living organism includes excising the portion of the tissue or said organ; and utilizing the cloned biological material as a part of the non-living medical device via physical attachment, wherein a shape of the cloned biological material is modified or refined for attachment to the non-living medical device; wherein the non-living medical device is a cardiac assist device, the cardiac assist device comprising a housing, said housing having a controller, a plurality of leads for sensing and receiving signals, an electrode for stimulating electrical pacing pulses to a heart, an outer sheath surrounding said housing, and the cloned biological material attached thereto forms a part of the non-living medical device to reduce or prevent immune reactions in the living organism that result from contact between the non-living medical device and the living organism; wherein a part of the non-living medical device that makes contact with the living organism is comprised of the cloned biological material. 2. The method of claim 1, wherein the step of preparing said cloned biological material from said tissue or said organ further comprises: isolating a cellular material from said portion of said tissue or said organ; dissociating said cellular material into a cell suspension using cell separation to obtain desired cells; and growing the desired cells on a shaped matrix to form said cloned biological material. 3. The method of claim 2, wherein isolating said cellular material from said portion of said tissue or said organ includes disaggregating said cellular material from said tissue with a digestive enzyme. 4. The method of claim 3, wherein the digestive enzyme is selected from a group consisting of: trypsin, chymotrypsin, collagenase, elastase, hydraluronidase, DNase, pronase, and dispase. 5. The method of claim 2, wherein isolating said cellular material from said portion of said tissue or said organ includes treating said tissue or said organ with a chelating agent. 6. The method of claim 1, wherein said tissue is a connective tissue. 7. The method of claim 2, wherein said desired cells are selected from a group consisting of: pericytes, adipoctyes, macrophages, monocytes, plasma cells, mast cells, and endothelial cells. 8. The method of claim 1, wherein said tissue is selected from a group consisting of: articular cartilage, auricular cartilage, costal cartilage, elastic cartilage, fibrous cartilage, hyaline cartilage, meniscal cartilage, and yellow cartilage. 9. The method of claim 2, wherein said desired cells are articular chronodrocytes from articular cartilage. 10. The method of claim 1, wherein said tissue is fetal neonatal foreskin. 11. The method of claim 2, wherein said cell separation to obtain said desired cells is selected from the group consisting of: negative separation, filtration, centrifugation, electrophoresis, unit gravity separation, cloning and cell selection, or a combination thereof. 12. The method of claim 2, wherein said shaped matrix is least one of a tubular structure, a thread-like structure, a twisted rope structure, a flat structure, a sheet structure, a spherical structure, a rod structure, a cubical structure or a combination thereof. 13. The method of claim 1, wherein preparing said cloned biological material includes removing said portion of said tissue or said organ from a donor. 14. The method of claim 2, wherein said shaped matrix comprises is at least one of a porous material, a non-porous material, a biodegradable material, a non-biodegradable material biodegradable material, and a combination thereof. 15. The method of claim 14, wherein said biodegradable material is selected from the group consisting of: a polyglycolic acid, a collagen, a polyorthoester, a polycaprolactone, a collagen sponge, a woven collagen, a gelatin, a polylactic acid, a polyglycolic acid, and combination thereof. 16. The method of claim 14, wherein said non-biodegradable material is selected from a group consisting of: a polyamide, a polyester, a polyesteramide, a polystrene, a fluorinated ethylene propylene, a polypropylene, a polyacrylate, polyvinyl, a polycarbonate, a polytetrafluoroethylene, a polyethylene, a polyethylene terapthalate, a silicone, a silicone rubber, a polysulfone, a thermanox, a polyurethane, a polyacrylics, a polyhydroxymethyacrylate, and a nitrocellulose. 17. The method of claim 1, wherein said non-living medical device is comprised of a non-biological material selected from a group consisting of: a carbon polymer, an inorganic fiber, a nanofiber, an amorphous carbon, a pyrolytic carbon, a vitreous carbon, a glassy carbon, a metal, an alloy, a silicone elastomer, a rubber, a polymer, a polylysine, a polyglycolic acid, a polyamide, a polyolefin, a polyester, a polyparadioxane, a polycarbonate, a polyether, a polyvinyl chloride, a polyurethane, a polystyrene, a polyacrylate polyethylene, a polypropylene, and a polytetrafluoroethylene. 18. The method of claim 1, wherein the cloned biological material is an enclosure on a catheter. 19. The method of claim 1, wherein said cloned biological material is a tube, a gasket, bolt or screw of the non-living medical device.

Details for Patent 9,393,351

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2031-03-10