Light delivery system with blood flushing capability

• US 5,833,682 A
• Filed: 08/26/1996
• Issued: 11/10/1998
• Est. Priority Date: 08/26/1996
• Status: Expired due to Fees

• Current Assignee: Michael Kasinkas
• Original Assignee: Illumenex Corporation
• Inventors: Ziebol, Robert J., Porter, Christopher H., Rydell, Mark A., Kasinkas, Michael, Amplatz, Curtis A.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): HARRIS, SONYA C
• Application Number:
  US08/697,530
• Time in Patent Office: 806 Days
• Field of Search: 606/2, 606/7, 606/8, 606/10, 606/11, 606/12, 606/13, 606/14, 606/15, 606/16, 606/17
• US Class Current: 606/15
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A light delivery system for use in irradiating vascular tissue includes a balloon catheter with a working lumen for receiving an optical fiber therein and an inflation/flushing lumen adapted to receive a liquid at a proximal end and leading to a space defined within the balloon member attached to a distal end of the catheter. The balloon member has a pattern of holes or pores in the wall thereof through which the saline may flow when the balloon is inflated, causing any blood or other absorbing substances that may interfere with good radiant energy transmission to be flushed away from the treatment site.

Claims

1. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:

(a) an elongated, flexible, tubular body member having a proximal end, a distal end portion and a plurality of lumens extending therebetween;

(b) a hub member connected to the proximal end of the body member and having a plurality of ports connected individually to the plurality of lumens in the body member;

(c) an inflatable member formed from a material generally transparent to light of a predetermined wavelength affixed to the distal end portion of the body member and in fluid communication with a first of the plurality of lumens for receiving an inflation fluid injected into one of the plurality of ports associated with the first of the plurality of lumens, the inflatable member including a plurality of pores for perfusing a portion of the inflation fluid therethrough at a rate sufficient to flush light absorbing substances from a zone in the blood vessel occupied by the inflatable member;

(d) an elongated, flexible, light guide member having a proximal end adapted to be coupled to a source of light energy and a distal end portion having a light diffusing surface joined thereto, said light guide member being of a size to fit through a second of the plurality of lumens, allowing the light diffusing surface to be positionable within the inflatable member; and

(e) means for controllably displacing the light diffusing surface longitudinally within the distal end portion of the tubular body member.

2. The light delivery system as in claim 1 wherein said inflatable member includes means for radially centering a distal end portion of the body member there within.

3. The light delivery system as in claim 2 wherein said means for radially centering the distal end portion of the body member comprises a flexible tab having opposed end portions bonded to an inner surface of the inflatable member at diametrically opposed locations and a centrally disposed aperture in the tab for receiving the distal end portion of the catheter body member therethrough.

4. The light delivery system as in claim 2 wherein said means for radially centering the distal end portion of the body member is comprised of an inflatable member that forms a spiral around the body member.

5. The light delivery system as in claim 1 and further including means for injecting a flushing liquid into one of said plurality of ports connected to a second of the plurality of lumens.

6. The light delivery system as in any one of claims 1-5 wherein the inflatable member is formed of a plastic selected from the class consisting of a polyethylene, FEP, PFA, PTFE, ETFE, PET, and nylon.

7. The light delivery system as in any one of claims 1-5 wherein the inflatable member is formed from an elastomer.

8. The light delivery system as in claim 7 wherein the elastomer material is selected from the group consisting of polyurethane, latex, and silicone.

9. The light delivery system as in any one of claims 1-5 wherein at least the distal end portion of the body member is of a material exhibiting a relatively low loss in transmission of light energy of the predetermined wavelength.

10. The light delivery system as in claim 9 wherein the material is PTFE.

11. The light delivery system as in any one of claims 1-5 wherein said plurality of pores are uniformly distributed in a circumferential band whose width is about one-half of a length dimension of the inflatable member.

12. The light delivery system as in any one of claims 1-5 wherein the size of the pores is between about 0.1 and 250 microns.

13. The light delivery system as in any one of claims 1-5 wherein the pores are slits.

14. The light delivery system as in any one of claims 1-5 and further including means cooperating with the inflatable member for inhibiting flow of blood into the inflatable member following inflation and during deflation thereof.

15. The light delivery system as in claim 14 wherein the inhibiting means comprises at least one elastic band overlying the inflatable member.

16. The light delivery system as in claim 15 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores in the inflatable member.

17. The light delivery system as in any one of claims 1-5 wherein the plurality of pores are normally closed and open when pressure of the fluid injected into the one of the plurality of ports associated with the first lumen exceeds a predetermined value.

18. The light delivery system as in claim 17 wherein the pores are slits formed in the inflatable member.

19. The light delivery system as in any one of claims 1-5 and further including means for removing blood that may have entered the inflatable member.

20. The light delivery system as in claim 19 wherein the removing means includes means for increasing the flow of said fluid through said pores.

21. The light delivery system as in any one of claims 1-5 and further including a perfusion lumen in the tubular body member for permitting blood to flow past the inflatable member while it is inflated.

22. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:

(a) an elongated, flexible, tubular body member having a proximal end, a distal end portion and a working lumen and an inflation lumen extending from a hub member on the proximal end to the distal end portion thereof;

(b) an expansible, elongated, balloon member coaxially disposed on and bonded to the body member near the distal end portion, with the inflation lumen being in fluid communication with an interior of the balloon member, the balloon member adapted to be inflated by an inflation fluid injected into the inflation lumen, the balloon member including a plurality of pores of a predetermined size extending through a wall surface thereof for permitting a fraction of the inflation fluid to pass therethrough;

(c) a waveguide having a proximal end connectable to a source of light energy and a distal end including a light diffusing member, the waveguide sized to fit through the working lumen of the body member such that the light diffusing member can be advanced into the distal end portion of the body member spanned by the balloon member; and

(d) means coupled to the hub member and to the waveguide for controlled, step-wise displacement of the light diffusing member within the distal end portion of the body member spanned by the balloon member.

23. The light delivery system as in claim 22 and further including a first pump coupled to the hub for injecting a liquid into the inflation lumen.

24. The light delivery system as in claim 23 and further including a second pump coupled to the hub for injecting a liquid into the working lumen.

25. The light delivery system as in claim 22 wherein the distal end portion of the body member and the balloon member are light energy transmissive.

26. The light delivery system as in claim 25 wherein the distal end portion of the catheter body member and the balloon member are made of materials capable of transmitting light of a predetermined wavelength with less than about a 50 percent loss.

27. The light delivery system as in claim 26 wherein the materials are selected from a group consisting of polyethylene, FEP, PFA, PTFE, ETFE, PET, nylon, polyurethane, latex, or silicone.

28. The light delivery system as in claim 22 and further including balloon centering means for maintaining the balloon member concentrically centered on the distal end portion of the catheter body member.

29. The light delivery system as in claim 28 wherein the centering means comprises a flexible tab member disposed within the balloon member and having first and second opposed ends bonded to the balloon member at diametrically disposed locations and an aperture through the tab located midway between the first and second opposed ends, for receiving the catheter body member therethrough.

30. The light delivery system as in claim 29 wherein said means for radially centering the distal end portion of the body member is comprised of a balloon member that forms a spiral around the body member.

31. The light delivery system as in claim 22 and further including means cooperating with the balloon member for inhibiting flow of blood into the balloon member following inflation and during subsequent deflation thereof.

32. The light delivery system as in claim 31 wherein the inhibiting means comprises at least one elastic band overlying the wall surface of the balloon member.

33. The light delivery system as in claim 32 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores in the inflatable member.

34. The light delivery system as in any one of claims 22-24 and 25-31 wherein the plurality of pores are normally closed and open when pressure of the fluid injected into the one of the plurality of ports associated with the first lumen exceeds a predetermined value.

35. The light delivery system as in any one of claims 22-24 and 25-31 wherein the pores are slits formed in the inflatable member.

36. The light delivery system as in any one of claims 22-24 and 25-31 wherein said plurality of pores are uniformly distributed in a circumferential band whose width is about one-half of a length dimension of the balloon member.

37. The light delivery system as in any one of claims 22-24 and 25-31 wherein the size of the pores is between about 0.1 and 250 microns.

38. The light delivery system as in any one of claims 22-24 and 25-31 wherein the pores are slits.

39. The light delivery system as in any one of claims 22-24 and 25-31 and further including means for removing blood that may enter the balloon member.

40. The light delivery system as in claim 39 wherein the removing means includes means for increasing the flow of said fluid through the pores.

41. The light delivery system as in claim 22 and further including a perfusion lumen in the tubular body member for permitting blood to flow past the balloon member while it is inflated.

42. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:

(a) an elongated, flexible, tubular body member having a proximal end, a distal end portion and a plurality of lumens extending therebetween;

(b) a hub member connected to the proximal end of the body member and having a plurality of ports connected individually to the plurality of lumens in the body member;

(c) an inflatable member formed from a material generally transparent to light of a predetermined wavelength affixed to the distal end portion of the body member and in fluid communication with a first of the plurality of lumens for receiving an inflation fluid injected into one of the plurality of ports associated with the first of the plurality of lumens, the inflatable member including a plurality of pores for perfusing a portion of the inflation fluid therethrough at a rate sufficient to flush light absorbing substances from a zone in the blood vessel occupied by the inflatable member, said plurality of pores being uniformly distributed in a circumferential band whose width is about one-half of the length dimension of the inflatable member; and

(d) an elongated, flexible, light guide member having a proximal end adapted to be coupled to a source of light energy and a distal end portion having a light diffusing surface joined thereto, said light guide member being of a size to fit through a second of the plurality of lumens, allowing the light diffusing surface to be positionable within the inflatable member.

43. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:

(a) an elongated, flexible, tubular body member having a proximal end, a distal end portion and a working lumen and an inflation lumen extending from a hub member on the proximal end to the distal end portion thereof;

(b) an expansible, elongated, balloon member coaxially disposed on and bonded to the body member near the distal end portion, with the inflation lumen being in fluid communication with an interior of the balloon member, the balloon member including a plurality of pores of a predetermined size extending through a wall surface thereof;

(c) a waveguide having a proximal end connectable to a source of light energy and a distal end including a light diffusing member, the waveguide sized to fit through the working lumen of the body member such that the light diffusing member can be advanced into the distal end portion of the body member spanned by the balloon member; and

(d) means coupled to the hub and to the waveguide for controlled, step-wise displacement of the light diffusing member within the distal end portion of the body member spanned by the balloon member.

44. The light delivery system as in claim 43 and further including a first pump coupled to the hub for injecting a liquid into the inflation lumen.

45. The light delivery system as in claim 44 and further including a second pump coupled to the hub for injecting a liquid into the working lumen.

46. The light delivery system as in claim 43 wherein the distal end portion of the body member and the balloon member are light energy transmissive.

47. The light delivery system as in claim 43 wherein the distal end portion of the catheter body member and the balloon member are made of materials capable of transmitting light of a predetermined wavelength with less than about a 50 percent loss.

48. The light delivery system as in claim 47 wherein the materials are selected from a group consisting of polyethylene, FEP, PFA, PTFE, ETFE, PET, nylon, polyurethane, latex, or silicone.

49. The light delivery system as in claim 43 and further including balloon centering means for maintaining the balloon member concentrically centered on the distal end portion of the catheter body member.

50. The light delivery system as in claim 49 wherein the centering means comprises a flexible tab member disposed within the balloon member and having first and second opposed ends bonded to the balloon member at diametrically disposed locations and an aperture through the tab located midway between the first and second opposed ends, for receiving the catheter body member therethrough.

51. The light delivery system as in claim 49 wherein said means for radially centering the distal end portion of the body member is comprised of a balloon member that forms a spiral around the body member.

52. The light delivery system as in claim 43 and further including means cooperating with the balloon member for inhibiting flow of blood into the balloon member following inflation and during subsequent deflation thereof.

53. The light delivery system as in claim 52 wherein the inhibiting means comprises at least one elastic band overlying the wall surface of the balloon member.

54. The light delivery system as in claim 53 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores n the inflatable member.

55. The light delivery system as in claim 43 wherein the plurality of pores are normally closed and open when pressure of the fluid injected into the one of the plurality of ports associated with the first lumen exceeds a predetermined value.

56. The light delivery system as in claim 43 wherein the pores are slits formed in the inflatable member.

57. The light delivery system as in claim 43 wherein the size of the pores is between about 0.1 and 250 microns.

58. The light delivery system as in claim 43 wherein the pores are slits.

59. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:

(a) an elongated, flexible, tubular body member having a proximal end, a distal end portion and a working lumen and an inflation lumen extending from a hub member on the proximal end to the distal end portion thereof;

(b) an expansible, elongated, balloon member coaxially disposed on and bonded to the body member near the distal end portion, with the inflation lumen being in fluid communication with an interior of the balloon member, the balloon member adapted to be inflated by an inflation fluid injected into the inflation lumen, the balloon member including a plurality of pores of a predetermined size extending through a wall surface thereof, the plurality of pores being normally closed and open when pressure of the fluid injected into the one of the plurality of pores associated with the first lumen exceeds a predetermined value; and

(c) a waveguide having a proximal end connectable to a source of light energy and a distal end including a light diffusing member, the waveguide sized to fit through the working lumen of the body member such that the light diffusing member can be advanced into the distal end portion of the body member spanned by the balloon member.

60. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:

(a) an elongated, flexible, tubular body member having a proximal end, a distal end portion and a working lumen and an inflation lumen extending from a hub member on the proximal end to the distal end portion thereof;

(b) an expansible, elongated, balloon member coaxially disposed on and bonded to the body member near the distal end portion, with the inflation lumen being in fluid communication with an interior of the balloon member, the balloon member adapted to be inflated by an inflation fluid injected into the inflation lumen, the balloon member including a plurality of pores of a predetermined size extending through a wall surface thereof, said plurality of pores being uniformly distributed in a circumferential band whose width is about one-half of a length dimension of the balloon member; and

(c) a waveguide having a proximal end connectable to a source of light energy and a distal end including a light diffusing member, the waveguide sized to fit through the working lumen of the body member such that the light diffusing member can be advanced into the distal end portion of the body member spanned by the balloon member.

61. A light delivery system for exposing the interior wall of a blood vessel to light energy comprising:

(a) an elongated, optical waveguide adapted to be connected at a proximal end to a source of light energy and having a light energy dispersing element at a distal end thereof;

(b) a balloon catheter having an elongated flexible plastic catheter body having a proximal end, a distal end and a plurality of lumens extending therebetween and an inflatable expander member affixed to the catheter body at the distal end thereof, the expander member being in fluid communication with one of the plurality of lumens and the optical waveguide being insertable through another of the plurality of lumens, said means for flushing light absorbing substances comprising a plurality of fluid pervious pores formed in the expander member; and

(c) means for flushing light absorbing substances from a zone between the energy dispersing element and the blood vessel wall at the treatment site.

62. The light delivery system as in claim 61 and further including means for inhibiting flow of blood clouded fluid through the pores formed in the expander member following inflation and subsequent deflation thereof.

63. The light delivery system as in claim 61 and further including means for removing blood that may have entered the expander member.

64. The light delivery system as in claim 61 wherein the elongated optical waveguide comprises a fiber-optic bundle including a plurality of optical fibers, said fiber optic bundle extending along said another of a plurality of lumens from the proximal end to an exit port formed through the catheter body at a location within the inflatable expander member, said plurality of optical fibers being routed over an outer surface of the catheter body at radially spaced locations.

65. The light delivery catheter as in claim 64 and further including slidable means surrounding the catheter body to which distal ends of the plurality of optical fibers are attached.