Method for treating an arterial wall injured during angioplasty

• US 5,092,841 A
• Filed: 05/17/1990
• Issued: 03/03/1992
• Est. Priority Date: 05/17/1990
• Status: Expired due to Fees

• Current Assignee: Wayne State University
• Original Assignee: Wayne State University
• Inventors: Spears, James R.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US07/525,104
• Time in Patent Office: 656 Days
• Field of Search: 604/96, 604/101, 604/113, 606/7, 606/8, 606/13-15, 606/192-195, 600/36, 623/1, 623/12, 128/395, 128/397, 128/398, 128/399-401
• US Class Current: 604/103.01
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/28 for heating a thermal probe or absorber
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22064 transparent liquid
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22085 light-absorbing A61B2017/22087 takes precedence
• CPC Class Codes: A61B 2017/22087 photodynamic
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been mechanically injured during an angioplasty procedure, the arterial wall and the plaque including fissures resulting therefrom, the method comprising the steps of positioning an angioplasty catheter adjacent to the lesion being treated; delivering a bioprotective material between the arterial wall and the angioplasty catheter so that the bioprotective material is entrapped therebetween and permeates into the fissures and small vessels of the arterial wall during apposition of the angioplasty catheter to the arterial wall; applying thermal energy to the lesion, thereby bonding the bioprotective material to the arterial wall and within the fissures; and removing the angioplasty catheter, the bioprotective material remaining adherent to the arterial wall and within the fissures, thereby coating the luminal surface of the arterial wall with an insoluble layer of the bioprotective material so that the insoluble layer provides at least semi-permanent protection to the arterial wall, despite contact with blood flowing adjacent thereto.

Claims

1. A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been injured during an angioplasty procedure, the arterial wall and the plaque including fissures resulting therefrom, the method comprising the steps of:

positioning an angioplasty catheter adjacent to the lesion being treated;

delivering a bioprotective material between the arterial wall and the angioplasty catheter so that the bioprotective material is entrapped therebetween and permeates into the fissures and vessels of the arterial wall during apposition of the angioplasty catheter thereto;

applying thermal energy to the lesion, thereby bonding the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; and

removing the angioplasty catheter, the bioprotective material remaining adherent to the arterial wall and within the fissures and vessels thereof, thereby coating the luminal surface with an insoluble layer of the bioprotective material so that the insoluble layer provides at least semi-permanent protection to the arterial wall, despite contact with blood flowing adjacent thereto.

4. The method of claim 1 wherein the bioprotective material utilized is macroaggregated albumin which bonds to the luminal surface and within fissures and vessels of the aterial wall as a result of the application of thermal energy.

5. The method of claim 1 wherein the bioprotective material utilized comprises platelets, injected as a suspension, which upon being trapped between the inflatable balloon and the luminal surface become adherent to the luminal surface and to tissues adjacent to fissures and vessels of the arterial wall as a result of the application of thermal energy.

6. The method of claim 1 wherein the bioprotective material comprises red blood cells, injected as a suspension, which upon being trapped between the inflatable balloon and the luminal surface become adherent to the luminal surface and to tissues adjacent to fissures and vessels of the arterial wall as a result of the application of thermal energy.

7. The method of claim 1 wherein the bioprotective material comprises liposomes, injected as a suspension, which upon being trapped between the inflatable balloon and the luminal surface become adherent to the luminal surface and to tissues adjacent to fissures and vessels of the arterial wall as a result of the application of thermal energy.

8. The method of claim 1 wherein the bioprotective material utilized is gelatin which upon being trapped between the inflatable balloon and the luminal surface bonds to the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.

9. The method of claim 1 wherein the bioprotective material utilized is a solution of fibrinogen which upon being trapped between the inflatable balloon and the luminal surface precipitates onto the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.

10. The method of claim 1 wherein the bioprotective material utilized is a solution of collagen which upon being trapped between the inflatable balloon and the luminal surface precipitates onto the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.

11. The method of claim 1 wherein the bioprotective material utilized is a solution of a high molecular carbohydrate which upon being trapped between the inflatable balloon and the luminal surface precipitates onto the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.

12. The method of claim 1 wherein the bioprotective material utilized entraps a useful pharmaceutical agent in order to provide local drug therapy directly to the luminal surface, and to deeper layers of the arterial wall.

13. The method of claim 12 wherein the useful pharmaceutical agent is an anti-coagulant.

14. The method of claim 12 wherein the useful pharmaceutical agent is a fibrinolytic agent.

15. The method of claim 12 wherein the useful pharmaceutical agent is a thrombolytic agent.

16. The method of claim 12 wherein the useful pharmaceutical agent is an anti-inflammatory agent.

17. The method of claim 12 wherein the useful pharmaceutical is an anti-proliferative compound.

18. The method of claim 12 wherein the useful pharmaceutical is an immunosuppressant.

19. The method of claim 12 wherein the useful pharmaceutical is a collagen inhibitor.

20. The method of claim 12 wherein the useful pharmaceutical is an endothelial cell growth promotor.

21. The method of claim 12 wherein the useful pharmaceutical is a sulfated polysaccharide.

22. The method of claim 1 wherein the bioprotective material includes a drug which is bound to albumin in solution prior to injection so that the drug is permanently affixed thereto by application of the thermal energy.

23. The method of claim 1 wherein the bioprotective material includes a drug which is physically trapped within a precipitated layer of albumin after the drug is injected with a solution of albumin.

24. The method of claim 1 wherein the bioprotective material comprises microspheres.

25. The method of claim 1 wherein the bioprotective material includes a drug preparation having an encapsulating medium.

26. The method of claim 25 wherein the encapsulating medium comprises albumin.

27. The method of claim 25 wherein the encapsulating medium comprises carbohydrates.

28. The method of claim 25 wherein the encapsulating medium comprises platelets.

29. The method of claim 25 wherein the encapsulating medium comprises liposomes.

30. The method of claim 25 wherein the encapsulating medium comprises red blood cells.

31. The method of claim 25 wherein the encapsulating medium comprises gelatin.

32. The method of claim 25 wherein the encapsulating medium comprises fibrin.

33. The method of claim 25 wherein the encapsulating medium comprises a synthetic polymer.

34. The method of claim 25 wherein the encapsulating medium comprises a sulfated polysaccharide.

35. The method of claim 25 wherein the encapsulating medium comprises an inorganic salt.

36. The method of claim 25 wherein the encapsulating medium comprises a phosphate glass.

37. The method of claim 1 wherein the bioprotective material is a suspension of microspheres in a physiologic solution.

38. The method of claim 1 wherein the step of removing the angioplasty catheter is followed by the step of bonding the bioprotective material to the lesion so that the bioprotective material remains adherent to the arterial wall, and fills cracks and recesses therewithin, thereby providing a smooth, luminal surface.

39. The method of claim 1 wherein the bioprotective material is delivered from a sleeve thereof provided upon the angioplasty catheter, the sleeve being disposed adjacent the arterial wall during apposition of the angioplastic catheter thereto, so that the sleeve of bioprotective material is transferred therefrom to the luminal surface, thereby becoming persistently affixed thereto upon applying the thermal energy and removing the angioplasty catheter.

40. The method of claim 1 wherein microspheres are formed in situ at the luminal surface and within the arterial wall as a result of the thermal energy applied to the bioprotective material.

41. The method of claim 1 wherein a drug, simultaneously injected with the bioprotective material, is entrapped within microspheres.

42. The method of claim 1 wherein the bioprotective material functions as a physiologic glue, thereby enhancing thermal fusion of fissured tissues within the arterial wall.

43. The method of claim 1 wherein the bioprotective material includes a chromophore which enhances absorption of electromagnetic radiation.

44. The method of claim 1 wherein a photosensitive dye is entrapped within the bioprotective material.

45. The method of claim 25 wherein the encapsulating medium comprises a chromophore which enhances absorption of electromagnetic radiation.

46. The method of claim 45 wherein the encapsulating medium entraps a photosensitive dye.

47. The method of claim 1 wherein the angioplasty catheter is a metal probe.

48. The method of claim 1 wherein the applied thermal energy is electromagnetic radiation.

49. The method of claim 48 wherein the applied thermal energy is continuous wave electromagnetic radiation.

50. The method of claim 48 wherein the applied thermal energy is pulsed electromagnetic radiation.

51. The method of claim 48 wherein the electromagnetic radiation is laser radiation.

52. The method of claim 48 wherein the electromagnetic radiation is radio-frequency radiation.

53. The method of claim 48 wherein the electromagnetic radiation is microwave radiation.

54. The method of claim 48 wherein the electromagnetic radiation is generated from electrical resistance.

55. The method of claim 1 wherein the bioprotective material is injected into the artery through the angioplasty catheter which is placed proximal to the lesion being treated.

60. The method of claim 1 wherein the step of applying thermal energy to the lesion comprises applying the thermal energy from the angioplasty catheter radially outwardly.

61. The method of claim 1 wherein the step of applying thermal energy to the lesion comprises delivering the thermal energy from a source thereof disposed outside the arterial wall radially inwardly.

62. The method of claim 1 wherein the step of applying thermal energy to the lesion comprises the step of applying thermal energy so that the temperature within the bioprotective material is raised to at least 50°

C.

2. The method of claim wherein the angioplasty catheter utilized includes an inflatable balloon.

3. The method of claim 2 wherein the inflatable balloon is at least partially inflated before delivering the bioprotective material between the arterial wall and the inflatable balloon so that the layer of the bioprotective material may be formed therebetween.

56. The method of claim 2 wherein the bioprotective material is injected through a channel within the angioplasty catheter to the arterial wall by exiting through ports located proximal to the inflatable balloon.

57. The method of claim 2 wherein the bioprotective material is injected through the angioplasty catheter to the arterial wall through microscopic perforations provided within the inflatable balloon.

58. A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been injured during an angioplasty procedure, the arterial wall and the plaque including fissures resulting therefrom, the method comprising the steps of:

positioning an angioplasty catheter adjacent to the lesion being treated;

delivering a bioprotective material between the arterial wall and the angioplasty catheter so that the bioprotective material is entrapped therebetween and permeates into the fissures and vessels of the arterial wall during apposition of the angioplasty catheter thereto;

applying thermal energy to the lesion, thereby bonding the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; and

removing the angioplasty catheter, the bioprotective material remaining adherent to the arterial wall and within the fissures and vessels thereof, thereby coating the luminal surface with an insoluble layer of the bioprotective material so that the insoluble layer provides at least semi-permanent protection to the arterial wall, despite contact with blood flowing adjacent thereto.

59. A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall and the plaque including fissures resulting therefrom, the method comprising the steps of:

performing angioplasty;

positioning an angioplasty catheter adjacent to the lesion being treated;

delivering a bioprotective material between the arterial wall and the angioplasty catheter so that the bioprotective material is entrapped therebetween and permeates into the fissures and vessels of the arterial wall during apposition of the angioplasty catheter thereto;

applying thermal energy to the lesion, thereby bonding the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; and

removing the angioplasty catheter, the bioprotective material remaining adherent to the arterial wall and within the fissures and vessels thereof, thereby coating the luminal surface with an insoluble layer of the bioprotective material so that the insoluble layer provides at least semi-permanent protection to the arterial wall, despite contact with blood flowing adjacent thereto.