Polymeric endoluminal paving process

• US 5,749,915 A
• Filed: 06/07/1995
• Issued: 05/12/1998
• Est. Priority Date: 08/24/1988
• Status: Expired due to Term

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Focal PLLC
• Inventors: Slepian, Marvin J.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/481,220
• Time in Patent Office: 1,070 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 424/422, 424/423, 600/36, 604/36, 604/48, 604/52, 604/82, 604/83, 604/96, 606/194, 606/191
• US Class Current: 128/898
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/0042 Materials resorbable by the body
• CPC Class Codes: A61L 24/046 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043 takes precedence
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/52 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0043 : characterised by structural features
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10S 977/773 : Nanoparticle, i.e. structure having three dimensions of 100 nm or less
• CPC Class Codes: Y10S 977/788 : Of specified organic or carbon-based composition
• CPC Class Codes: Y10S 977/795 : Composed of biological material

Abstract

A method for applying a paving material to a tissue surface is described. The method involves positioning a non-fluent polymeric material at the surface to be paved, rendering the material fluent, contacting the fluent polymer with the tissue surface, and allowing the polymer to return to its non-fluent condition.

Claims

1. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature and which is fluent at an elevated temperature;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) heating the polymeric material to render the polymeric material fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to cool into a non-fluent biocompatible coating on the surface,

wherein the polymeric coating is biodegradable.

2. A method as in claim 1 wherein the biodegradable polymeric coating further includes a therapeutic agent.

3. A method as in claim 2 wherein the therapeutic agent is selected from the group consisting of anti-thrombotic agents, thrombolytic agents, vasodilating agents, anti-proliferative agents, intercalating agents, growth modulating factors, monoclonal antibodies, anti-imflammatory agents, lipid and cholesterol sequestrants, antisense oligonucleotides, ribozymes, aptomers, and combinations thereof.

4. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the tissue surface comprises a lumen in a body vessel.

5. A method as in claim 4 wherein the body vessel comprises a blood vessel.

6. A method as in claim 5 wherein the polymeric cylinder is positioned using a dilatation catheter having a radially expandable portion.

7. A method as in claim 6 wherein prior to the molding step, the polymeric cylinder is positioned about the radially expandable portion of the dilatation catheter.

8. A method as in claim 7 wherein the molding is achieved by expanding the radially expandable portion of the dilatation catheter.

9. A method as in claim 4 wherein prior to the molding step, the biocompatible polymeric material comprises a polymeric cylinder having an outside diameter that is substantially smaller than the diameter of the tissue lumen.

10. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the modifying step comprises heating the polymer using radio frequency energy, or radiation produced by fission or fusion processes.

11. A method as in claim 10 wherein the temperature of the polymer is modified using radio frequency energy.

12. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the modifying step comprises heating the polymer using light.

13. A method as in claim 12 wherein the light has a wavelength in the infrared, visible or ultraviolet spectrum.

39. A method as in claim 12 wherein the biodegradable polymeric coating further includes a therapeutic agent.

40. A method as in claim 39 wherein the therapeutic agent is selected from the group consisting of anti-thrombotic agents, thrombolytic agents, vasodilating agents, anti-proliferative agents, intercalating agents, growth modulating factors, monoclonal antibodies, anti-inflammatory agents, lipid and cholesterol sequestrants, antisense olgonucleotides, ribozymes, aptomers, and combinations thereof.

14. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the modifying step comprises heating the polymer using resistance heating.

15. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the coating comprises a plurality of isolated domains.

16. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer subsequent to or simultaneously with the positioning step to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface.

17. A method as in claim 16, wherein the providing step comprises providing a biocompatible polymeric material which is non-fluent at body temperature and which is fluent at an elevated temperature, the modifying step comprises heating the polymeric material to render the polymeric material fluent, and the allowing step comprises allowing the polymeric material to cool into a non-fluent biocompatible coating on the surface.

18. A method as in claim 17 wherein the biocompatible polymeric coating is selected from the group consisting of polymers and copolymers of carboxylic acids, polyurethanes, polyesters, polyamides, polyacrylonitriles, polyphosphazenes, polylactones, polyanhydrides, polyethylenes, polyalkylsulfones, polycarbonates, polyhydroxybutyrates, polyhydroxyvalerates, hydrocarbon polymers, polypropylenes polyvinylchlorides, ethylene vinyl acetates, and combinations thereof.

19. A method as in claim 16 wherein the biocompatible polymeric coating is selected from the group consisting of polymers and copolymers of carboxylic acids, polyurethanes, polyesters, polyamides, polyacrylonitriles, polyphosphazenes, polylactones, polyanhydrides, polyethylenes, polyalkylsulfones, polycarbonates, polyhydroxybutyrates, polyhydroxyvalerates, hydrocarbon polymers, polypropylenes polyvinylchlorides, ethylene vinyl acetates, and combinations thereof.

20. A method as in any of claims 18 or 19 wherein the polymer comprises a material selected from the group of polycaprolactone, delta-valerolactone, p-dioxanone, polyglycolic acids, polylactic acids, and copolymers thereof.

21. A method as in claim 17 wherein the resulting polymeric coating has a thickness in the range of approximately 0.001-1.0 mm.

22. A method as in claim 17 wherein the polymer is heated via a heated fluid.

23. A method as in claim 22 wherein the fluid is selected from the group consisting of water and saline.

24. A method as in claim 17 wherein the coating is a continuous layer.

25. A method as in claim 24 wherein the substantially continuous layer includes perforations.

26. A method as in claim 17 wherein the coating opposite the tissue surface is substantially smooth.

27. A method as in any of claims 17, or 16 wherein the biocompatible polymeric material comprises a physical blend of polymers selected from the group consisting of biostable polymers, biodegradable polymers, and combinations thereof.

28. A method as in any of claims 17, or 16 wherein multiple coating layers are deposited to provide a composite coating.

29. A method as in any of claims 18 or 19 wherein the polyamide comprises nylon.

30. A method as in claim 16 wherein the resulting polymeric coating has a thickness in the range of approximately 0.001-1.0 mm.

31. A method as in claim 16 wherein the temperature of the polymer is modified using a fluid.

32. A method as in claim 31 wherein the fluid is selected from the group consisting of water and saline.

33. A method as in claim 16 wherein the coating is a substantially continuous layer.

34. A method as in claim 33 wherein the substantially continuous layer includes perforations.

35. A method as in claim 16 wherein the coating has a surface opposite the tissue surface that is substantially smooth.

36. A method as in claim 16 wherein the modifying step is carried out subsequent to the positioning step.

37. A method as in claim 16 wherein the modifying step comprises modifying the temperature of the polymer to effect a phase change in the material.

38. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the polymeric coating is biodegradable.

41. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be chanced by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the tissue surface comprises a lumen in a body vessel.

42. A method as in claim 41 wherein the body vessel comprises a blood vessel.

43. A method as in claim 42 wherein prior to the molding step, the biocompatible polymeric material comprises a polymeric cylinder having an outside diameter that is substantially smaller than the diameter of the tissue lumen.

44. A method as in claim 43 wherein the polymeric cylinder is positioned using a dilatation catheter having a radially expandable portion.

45. A method as in claim 44 wherein prior to the molding step, the polymeric cylinder is positioned about the radially expandable portion of the dilatation catheter.

46. A method as in claim 45 wherein the molding is achieved by expanding the radially expandable portion of the dilatation catheter.

47. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the modifying step comprises modifying the temperature of the polymer using light.

48. A method as in claim 47 wherein the light has a wavelength in the infrared, visible or ultraviolet spectrum.

49. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the coating comprises a plurality of isolated domains.

50. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the polymer comprises poly(bis(p-carboxyphenoxy)propane anhydride).

51. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the biocompatible polymeric material is coated on a tissue surface selected from the group consisting of veins, arteries, urethras, bronchi, biliary ducts, pancreatic ducts, the gut, the eye, eustachian tubes, spermatic tubes, fallopian tubes, arterio-venous fistulae, or aortic and other arterial aneurysms.

52. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the tissue contacting surface is selected from the group consisting or transhepatic portosystemic shunts and dialysis grafts.

53. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the coating incorporates separate domains of material selected from the group consisting of polymeric and metallic material.

54. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a chance in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the coating incorporates elements selected from the group consisting of microparticles, nanoparticles, microcapsules, nanocapsules, liposomes, and combinations thereof.

55. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the polymer is biodegradable and is crosslinked with a bis-caprolactone.

56. An in vivo method for forming a biocompatible polymeric coating on tissue or tissue-contacting surfaces which comprises the steps of:

a) providing a biocompatible polymeric material which is non-fluent at body temperature, the fluency of which can be changed by a change in temperature of the material;

b) positioning the polymeric material at a position substantially adjacent to the tissue or tissue-contacting surface to be coated;

c) modifying the temperature of the polymer to render it fluent;

d) molding the fluent polymeric material into substantially conforming contact with the surface; and

e) allowing the polymeric material to reach body temperature, thereby forming a non-fluent biocompatible coating on the surface,

wherein the polymeric material is provided in the form of a rolled sheet which may be expanded into contact with the surface to be coated.

57. A method as in claim 56 wherein the rolled sheet is rendered fluent prior to expansion.

58. A method as in claim 56 wherein the rolled sheet is rendered fluent following expansion.