Compositions, methods, and kits for closure of lumen openings, and for bulking of tissue

• US 20020106411A1
• Filed: 05/25/2001
• Published: 08/08/2002
• Est. Priority Date: 02/02/2001
• Status: Abandoned Application

• Current Assignee: Regeneration Technologies Incorporated (Surgalign Holdings, Inc.)
• Original Assignee: Regeneration Technologies Incorporated (Surgalign Holdings, Inc.)
• Inventors: Wironen, John F., Donda, Russell S.
• Application Number:
  US09/865,318
• Publication Number:
  US 20020106411A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61F 2002/4435 Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• 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: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite

Abstract

Disclosed and claimed are compositions, devices, methods and kits that are useful in occluding lumens or bulking-up regions of tissues or organs in a living mammal. The invention pertains to a composition containing specific particulate components, wherein the particulates promote responsive body processes that contribute to the formation of the occlusion or bulked-up region.

Claims

1. A method of administering a closure-forming or bulking up composition in a living mammal, comprising

a. mixing together, to form a composition, at least one type of water-insoluble particle and a carrier;

and

b. applying the composition to at least one specific area of a lumen or other body region in need of closure;

whereby applying the composition results in closure or bulking up of the at least one specific area.

2. A method of administering a closure-forming or bulking up composition in a living mammal, comprising

a. mixing together, to form a composition, at least one type of water-insoluble particle that promotes responsive body processes and a carrier;

and

b. applying the composition to at least one specific area of a lumen or other body region in need of closure;

whereby applying the composition results in closure or bulking up of the at least one specific area.

3. A method of administering a closure-forming or bulking up composition in a living mammal, comprising

a. obtaining at least one type of water-insoluble particle that promotes responsive body processes, from the group consisting fine particles of bone;

fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range;

non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range;

collagen shards, preferably in the 125-250 micrometer particle size range;

insoluble salts, and talc;

b. mixing together, to form a composition, said at least one type of water-insoluble particle and a carrier; and

c. applying the composition to at least one specific area of a lumen or other body region in need of closure, or tissue or organ in need of bulking up;

whereby applying the composition results in closure or bulking up of the at least one specific area.

4. The method according to claim 3, wherein said carrier is selected from the group consisting of:

collagen;

gelatin;

carboxymethyl cellulose;

hyaluronic acid;

polyvinyl alcohol;

thrombin;

fibrin;

albumin; and

mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.

5. The method according to claim 3, additionally comprising the step of including an additive in the carrier, said additive selected from the group consisting of growth factors, biologically active agents, and combinations thereof.

6. The method according to claim 5, wherein at least one growth factor is selected from the group consisting of PDGF, FGF, VEGF, BMP, EGF, ECGF, and PDGF.

7. The method of claim 3 wherein said applying of the composition is done by percutaneous injection to a location in need thereof

20. The method according to claim 3,wherein said closure is for a lumen or channel in a structure selected from the group consisting of a vas deferens duct, a tear duct, a salivary gland duct, a sweat gland duct, an arteriovenous connection, an arteriovenous anastomosis, an artery supplying a tumor, a capillary plexus supplying a tumor, or a manmade channel in need of said closure.

21. The method according to claim 3,wherein said bulking up is for a tissue or organ selected from the group consisting of sphincter muscles and vocal chords

8. An implantable composition for administration to a lumen of a living mammal, to close the lumen, comprising:

a. water-insoluble particles, and

b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.

9. An implantable composition for administration to a lumen of a living mammal, to close the lumen, comprising:

a. water-insoluble particles that promote responsive body processes, and

b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.

11. The implantable composition according to claim 9, wherein the carrier is selected from the group consisting of:

collagen;

gelatin;

carboxymethyl cellulose;

hyaluronic acid;

polyvinyl alcohol;

thrombin;

fibrin;

albumin; and

mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.

12. The implantable composition according to claim 11, wherein the water-insoluble particles are selected from the group consisting of fine particles of bone;

fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range;

non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range;

collagen shards, preferably in the 125-250 micrometer particle size range;

insoluble salts, and talc.

16. The implantable composition according to claim 14, wherein the carrier is selected from the group consisting of:

collagen;

gelatin;

carboxymethyl cellulose;

hyaluronic acid;

polyvinyl alcohol;

thrombin;

fibrin;

albumin; and

mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyortho-esters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.

17. The implant according to claim 16, wherein the water-insoluble particles are selected from the group consisting of fine particles of bone;

fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range;

non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range;

collagen shards, preferably in the 125-250 micrometer particle size range;

insoluble salts, and talc.

19. The method according to claim 18, wherein the injection is percutaneous.

22. The implantable composition according to claim 9, wherein said lumen is selected from the group consisting of a vas deferens duct, a tear duct, a salivary gland duct, a sweat gland duct, an arteriovenous connection, an arteriovenous anastomosis, an artery supplying a tumor, a capillary plexus supplying a tumor, or a man-made channel in need of said closure.

23. The method according to claim 14, wherein said administration to add bulk is to a tissue or organ selected from the group consisting of sphincter muscles and vocal chords.

24. The implantable composition according to claim 18, wherein said adhesion formation is in a lumen selected from the group consisting of a vas deferens duct, a tear duct, a salivary gland duct, a sweat gland duct, an arteriovenous connection, an arteriovenous anastomosis, an artery supplying a tumor, a capillary plexus supplying a tumor, or a manmade channel in need of said closure.

25. The method according to claim 18, wherein said adhesion formation is in a tissue or organ selected from the group consisting of sphincter muscles and vocal chords.

27. The kit according to claim 26, wherein said carrier is selected from the group consisting of:

collagen;

gelatin;

carboxymethyl cellulose;

hyaluronic acid;

polyvinyl alcohol;

thrombin;

fibrin;

albumin; and

mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyorthoesters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.

28. The kit according to claim 26, wherein said water-insoluble particles are selected from the group consisting of fine particles of bone;

fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range;

non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range;

collagen shards, preferably in the 125-250 micrometer particle size range;

insoluble salts, and talc.

29. The kit according to claim 26, wherein said instructions provide for mixing said water-insoluble particles and said carrier in a syringe.

30. The kit according to claim 29, wherein said syringe has a flexible area of its barrel to facilitate mixing.

31. The kit according to claim 26, wherein at least one of said water insoluble particles and said carrier is provided in a syringe.

10. An implantable composition for administration to a lumen of a living mammal, to close the lumen, comprising:

a. water-insoluble particles that promote responsive body processes, and

b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution,

wherein said carrier compound is thermoplastic gelatin and said solution is flowable at a temperature above the body temperature of a subject living mammal, and is not flowable at the said body temperature.

13. An implantable composition for administration to a tissue or organ of a living mammal, to add bulk to the tissue or organ, comprising:

a. water-insoluble particles,

b. carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.

14. An implantable composition for administration to a tissue or organ of a living mammal, to add bulk to the tissue or organ, comprising:

a. water-insoluble particles that promote responsive body processes, and

b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution.

15. An implantable composition for administration to a tissue or organ of a living mammal, to add bulk to the tissue or organ, comprising:

a. water-insoluble particles that promote responsive body processes, and

b. a carrier compound, such that when combined in a liquid, the water-insoluble particles are suspended in a solution,

wherein said carrier compound is thermoplastic gelatin and said solution is flowable at a temperature above the body temperature of a subject living mammal, and is not flowable at the said body temperature.

18. A method of promoting the formation of an occlusion in a lumen, or a bulked-up region in a tissue or organ, comprising the steps of:

a. preparing a composition comprising water insoluble particles, said particles promoting formation of an adhesion, and

b. injecting a quantity of said composition into a body area of a living mammal, such that adhesion formation is promoted in the area of the injecting.

26. A kit for lumen-closing or a tissue-bulking implant for a living mammal, comprising:

a. an implantable composition comprising water-insoluble particles that promote one or more of cellular inflammation, infiltration, or adhesion, and a carrier to form a paste or suspension; and

b. instructions for delivering said implantable composition to a lumen, tissue or organ in need of occlusion or bulking,

wherein upon said delivering, an occlusion forms in the lumen, or a bulked up area forms in the tissue or organ of the living mammal.

32. A method for closure of a lumen, or bulking up of a tissue or organ in a living mammal, comprising:

a. obtaining a kit comprising an implantable composition comprising water-insoluble particles that promote one or more of cellular inflammation, infiltration, or adhesion, and a carrier to form a paste or suspension; and

b. administering said implantable composition to a lumen in need of closure, or to a tissue or organ in need of bulking up.

33.he. The method according to claim 32, additionally comprising following prescribed instructions for the preparation and mixing of said water-insoluble particles and said carrier to form said implantable composition.

34.he. The method according to claim 32, wherein said carrier is selected from the group consisting of:

collagen;

gelatin;

carboxymethyl cellulose;

hyaluronic acid;

polyvinyl alcohol;

thrombin;

fibrin;

albumin; and

mucoadhesive polysaccharides such as chitosan, polyalcohols, polyamines, polyvinyls, polyamides, polyesters, polyanhydrides, polyorthoesters, polyurethanes, polycarbonates, polyphosphazines, polysilicates, and mixtures thereof.

35.he. The method according to claim 32, wherein said, wherein said water-insoluble particles are selected from the group consisting of fine particles of bone;

fine particles of hydroxyapatite, in the 1 to 70 micrometers particle size range;

non-osteoinductive demineralized bone matrix, preferably in the 125-250 micrometer particle size range;

collagen shards, preferably in the 125-250 micrometer particle size range;

insoluble salts, and talc.