Low profile combination device for gastrostomy or jejunostomy applications having anti-granuloma formation characteristics

• US 20040024363A1
• Filed: 04/22/2003
• Published: 02/05/2004
• Est. Priority Date: 04/22/2002
• Status: Active Grant

• Current Assignee: Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Foundation)
• Original Assignee: Children's Hospital of Philadelphia (Children's Hospital of Philadelphia Foundation)
• Inventors: Goldberg, Elizabeth A.
• Granted Patent: US 6,997,909 B2
• Time in Patent Office: Days
• US Class Current: 604/175
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0042 inflatable
• CPC Class Codes: A61J 15/0065 Fixing means and tube being one part
• CPC Class Codes: A61J 15/0069 Tubes feeding directly to the intestines, e.g. to the jejunum
• CPC Class Codes: A61J 2200/60 biodegradable
• CPC Class Codes: A61J 2205/40 by shape or form, e.g. by using shape recognition
• CPC Class Codes: A61L 28/0038 Medicaments; Biocides
• CPC Class Codes: A61L 28/0061 Materials for coating
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2025/0273 having slits to place the pad around a catheter puncturing site
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A combination device for gastrostomy or jejunostomy usage having a retaining member, an elongated member having a gastrostomy lumen and a jejustomy lumen, and an inflatable balloon mounted on the elongated member. The retaining member is of a low profile and is arranged to be located on the skin adjacent a stoma in the abdominal wall through which the elongated member extends. The balloon seals the stoma about the elongated member. The retaining member includes at least one access port to communicate with respective ones of the lumens. The device, related compositions, and processes can prevent and/or treat granulomas.

Claims

1. A combination device for gastrostomy or jejunostomy usage, said device comprising a retaining member, an elongated member and an activatable sealing member, said elongated member having a proximal portion connected to said retaining member and having a longitudinal axis, said elongated member comprising a first lumen and a second lumen, said sealing member being mounted on said elongated member, said retaining member being arranged to be located on skin of a being adjacent a stoma in an abdominal wall of the being and having a low profile with respect to the being'"'"'s skin, said retaining member including a first access port and a second access port, each of said access ports extending generally parallel to said longitudinal axis and being arranged to have a respective tube coupled thereto, said elongated member being arranged to pass through the stoma so that said first lumen can serve as a gastrostomy tube and said second lumen can serve as a jejunostomy tube, said sealing member being located on said proximal portion of said elongated member and being arranged to seal an interface between the stoma and said proximal portion of said elongated member, said first lumen having a distal end and at least one first access port adjacent said distal end of said first lumen, said second lumen having a distal end and at least one second access port adjacent said distal end of said second lumen, each of said first and second access ports being arranged to provide communication to respective ones of said first and second lumens.

2. The combination device of claim 1, wherein each of said first and second access ports is of a different shape.

3. The combination device of claim 1, wherein each of said first and second access ports has respective distinctive indicia associated with it, whereupon said access ports can be readily distinguished from each other.

4. The combination device of claim 1, additionally comprising an anti-reflux valve.

5. The combination device of claim 1, wherein said first lumen is shorter in length than said second lumen.

6. The combination device of claim 1, wherein at least some portions of said device which may engage the tissue of the being at the stoma are provided with an anti-granuloma composition comprising at least one anti-granuloma agent.

7. The combination device of claim 6, wherein the anti-granuloma composition further comprises at least one controlled release agent.

8. The combination device of claim 6, wherein said retaining member includes a lower surface from which said proximal portion of said elongated member projects, and wherein said anti-granuloma composition is provided as a disk for disposition on said lower surface and about said proximal portion of said elongated member.

9. The combination device of claim 6, wherein said retaining member includes a lower surface from which said proximal portion of said elongated member projects, and wherein said anti-granuloma composition is provided as a sleeve for disposition about said proximal portion of said elongated member immediately adjacent said lower surface.

10. The combination device of claim 6, wherein said at least one anti-granuloma agent is at least one member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, a cytokine, a cytokine inhibitor, a growth factor, a vascular growth factor, a neutralizing antibody, a hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.

11. The combination device of claim 6, wherein said at least one anti-granuloma agent is at least one member selected from the group consisting of 9-fluoro-11β

, 16α

, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α

-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.

12. The combination device of claim 6, wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.

13. The combination device of claim 7, wherein said at least one controlled release agent is at least one member selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.

14. The combination device of claim 13, wherein said biodegradable polymer is a member selected from the group consisting of polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.

15. The combination device of claim 14, wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).

16. The combination device of claim 1 further comprising a plug member for sealing said access ports.

17. A device for gastrostomy or jejunostomy usage, said device comprising a retaining member, an elongated member and an activatable sealing member, said elongated member having a proximal portion connected to said retaining member and having a longitudinal axis, said elongated member comprising at least one lumen, said sealing member being mounted on said elongated member, said retaining member being arranged to be located on skin of a being adjacent a stoma in an abdominal wall of the being and including an access port arranged to have a tube coupled thereto, said elongated member being arranged to pass through the stoma, said sealing member being located on said proximal portion of said elongated member and being arranged to seal an interface between the stoma and said proximal portion of said elongated member, at least some portions of said device which may engage a tissue of the being at the stoma are provided with an anti-granuloma composition comprising at least one anti-granuloma agent.

18. The device of claim 17, wherein the anti-granuloma composition further comprises at least one controlled release agent.

19. The device of claim 17, wherein said retaining member includes a lower surface from which said proximal portion of said elongated member projects, and wherein said anti-granuloma composition is provided in the form of a disk for disposition on said lower surface and about said proximal portion of said elongated member.

20. The device of claim 17, wherein said retaining member includes a lower surface from which said proximal portion of said elongated member projects, and wherein said anti-granuloma composition is provided in the form of a sleeve for disposition about said proximal portion of said elongated member immediately adjacent said lower surface.

21. The device of claim 17, wherein said at least one anti-granuloma agent is a member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, cytokine, cytokine inhibitor, growth factor, vascular growth factor, neutralizing antibody, hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.

22. The device of claim 17, wherein said at least one anti-granuloma agent is a member selected from the group consisting of 9-fluoro- 11β

, 16α

, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α

-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.

23. The device of claim 17, wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.

24. The device of claim 18, wherein said at least one controlled release agent is a member selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.

25. The device of claim 24, wherein said biodegradable polymer is a member selected from the group consisting of a polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.

26. The device of claim 25, wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).

27. The combination device of claim 17 additionally comprising a plug member for sealing said access ports.

28. A member for use with a medical device for prolonged residence extending through an artificial opening in a body of a being, the medical device comprising an elongated member arranged to be extended through the opening from skin of the being, said member being arranged to be located contiguous with at least some portions of the medical device which may engage a tissue of the being at the opening, said member comprising an anti-granuloma composition comprising at least one anti-granuloma agent.

29. The member of claim 28, wherein the medical device comprises a portion arranged to be located on the skin of the being contiguous with the opening and having a lower surface from which said elongated member projects, and wherein said member comprises a disk for disposition on said lower surface and about said proximal portion of said elongated member, said disk bearing said anti-granuloma composition.

30. The member of claim 29, wherein said at least one anti-granuloma agent is a member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, cytokine, cytokine inhibitor, growth factor, vascular growth factor, neutralizing antibody, hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.

31. The member of claim 29, wherein said at least one anti-granuloma agent is a member selected from the group consisting of 9-fluoro-11β

, 16α

, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α

-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.

32. The member of claim 29, wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.

33. The member of claim 29, wherein the anti-granuloma composition further comprises at least one controlled release agent selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.

34. The member of claim 33, wherein said biodegradable polymer is a member selected from the group consisting of a polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.

35. The member of claim 34, wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).

36. The member of claim 29, wherein said disk is split.

37. The member of claim 28, wherein said member comprises a sleeve for disposition about said proximal portion of said elongated member, said sleeve bearing said anti-granuloma composition.

38. The member of claim 37, wherein said at least one anti-granuloma agent is a member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, cytokine, cytokine inhibitor, growth factor, vascular growth factor, neutralizing antibody, hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.

39. The member of claim 37, wherein said at least one anti-granuloma agent is a member selected from the group consisting of 9-fluoro-11β

, 16α

, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α

-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.

40. The member of claim 37, wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.

41. The member of claim 37, wherein the anti-granuloma composition further comprises at least one controlled release agent selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.

42. The member of claim 41, wherein said biodegradable polymer is a member selected from the group consisting of a polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.

43. The member of claim 42, wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).

44. The member of claim 37, wherein said sleeve is split.

45. In a process for providing an artificial channel across a tissue of a being, comprising providing an elongated member through the tissue, the improvement wherein the elongated member is provided with a coating comprising an anti-granuloma composition effective to prevent and/or treat granulomas.

46. The process of claim 45, wherein the anti-granuloma composition comprises at least one anti-granuloma agent and at least one controlled release agent, wherein the at least one anti-granuloma agent is mixed with the at least one controlled release agent and wherein the at least one anti-granuloma agent is provided in an amount effective to prevent and/or treat granulomas.

47. The process of claim 46, wherein the at least one anti-granuloma agent is a member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, a cytokine, a cytokine inhibitor, a growth factor, a vascular growth factor, a neutralizing antibody, a hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.

48. The process of claim 46, wherein said at least one anti-granuloma agent is a member selected from the group consisting of 9-fluoro-11β

, 16α

, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α

-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.

49. The process of claim 46, wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.

50. The process of claim 46, wherein said at least one controlled release agent is a member selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.

51. The process of claim 50, wherein said biodegradable polymer is a member selected from the group consisting of a polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.

52. The process of claim 50, wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).

53. The process of 45, wherein the coating is removable and is in a shape of a sleeve, a disk, a sheet, or a layer.