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 a 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 fluid therethrough at a rate sufficient to flush light absorbing substances from a zone in the blood vessel occupied by 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. 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 and further including means for controllably displacing the light diffusing surface longitudinally within the distal end portion of the tubular body member.
7. 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. 8. The light delivery system as in any one of Claims 1-5 wherein the inflatable member is formed from an elastomer.
9. The light delivery system as in Claim 8 wherein the elastomer material is selected from the group consisting of polyurethane, latex, and silicone.
10. 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.
11. The light delivery system as in Claim 10 wherein the material is PTFE.
12. 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.
13. 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.
14. The light delivery system as in any one of Claims 1-5 wherein the pores are slits-.
15. 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.
16. The light delivery system as in Claim 15 wherein the inhibiting means comprises at least one elastic band overlying the inflatable member.
17. The light delivery system as in Claim 16 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores in the inflatable member.
18. 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 .
19. The light delivery system as in Claim 18 wherein the pores are slits formed in the inflatable member. 20. 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.
21. The light delivery system as in Claim 20 wherein the removing means includes means for increasing the flow of said fluid through said pores.
22. 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. 23. 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; 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 .
24. The light delivery system as in Claim 23 and further including a first pump coupled to the hub for injecting a liquid into the inflation lumen.
25. The light delivery system as in Claim 24 and further including a second pump coupled to the hub for injecting a liquid into the working lumen. 26. The light delivery system as in any one of Claims 23-25 and further including 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. 27. The light delivery system as in Claim 26 wherein the distal end portion of the body member and the balloon member are light energy transmissive .
28. The light delivery system as in Claim 27 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.
29. The light delivery system as in Claim 28 wherein the materials are selected from a group consisting of polyethylene, FEP, PFA, PTFE, ETFE, PET, nylon, polyurethane, latex, or silicone. 30. The light delivery system as in Claim 23 and further including balloon centering means for maintaining the balloon member concentrically centered on the distal end portion of the catheter body member.
31. The light delivery system as in Claim 30 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.
32. The light delivery system as in Claim 31 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. 33. The light delivery system as in Claim 23 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 . 34. The light delivery system as in any one of Claims 23-25 and 27-33 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 23-25 and 27-33 wherein the pores are slits formed in the inflatable member.
36. The light delivery system as in Claim 33 wherein the inhibiting means comprises at least one elastic band overlying the wall surface of the balloon member.
37. The light delivery system as in Claim 36 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores in the inflatable member.
38. The light delivery system as in any one of Claims 23-25 and 27-33 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 .
39. The light delivery system as in any one of Claims 23-25 and 27-33 wherein the size of the pores is between about 0.1 and 250 microns.
40. The light delivery system as in any one of Claims 23-25 and 27-33 wherein the pores are slits.
41. The light delivery system as in any one of Claims 23-25 and 27-33 and further including means for removing blood that may enter the balloon member.
42. The light delivery system as in Claim 41 wherein the removing means includes means for increasing the flow of said fluid through the pores .
43. The light delivery system as in Claim 23 and further including a perfusion lumen in the tubular body member for permitting blood to flow past the balloon member while it is inflated.
44. 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) means for guiding the optical waveguide through the vascular system until the energy dispersing element is juxtaposed with a treatment site within the blood vessel; 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.
45. The light delivery system as in Claim 44 wherein the means for guiding is 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.
46. The light delivery system as in Claim 45 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.
47. The light delivery system as in Claim 45 and further including means for removing blood that may have entered the expander member .
48. The light delivery system as in Claim 45 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.
49. The light delivery catheter as in Claim 48 and further including slidable means surrounding the catheter body to which distal ends of the plurality of optical fibers are attached.
50. A method for delivering light energy to a predetermined site within a blood vessel of a patient, comprising the steps of : (a) surgically inserting an elongated, flexible, tubular guide member having a proximal end, a distal end and at least one lumen extending therebetween into a blood vessel and advancing the guide member until the distal end thereof is proximate the site;
(b) routing an optical waveguide having a light dispensing element on a distal end of the optical waveguide through at least one lumen of *the guide member until the light dispensing element is juxtaposed with the site;
(c) perfusing a flushing liquid through at least one lumen of the guide member for clearing the blood vessel of light occluding fluids at the site; and (d) applying light energy to a proximal end of the optical waveguide.
AMENDED CLAIMS
[received by the International Bureau on 09 March 1998 (09.03.98); original claims 44-50 cancelled; original claims 1-6,12,15-17,22-26.28,30-33,36-38 and 43amended; new claims 44-88 added; remaining claims unchanged (17 pages)] internal surface of a blood vessel with light energy, comprising: (a) an elongated, flexible, tubular body member
12 having a proximal end, a distal end portion and a plurality of lumens 14, 16, 17 extending therebetween;
(b) a hub member 20 connected to the proximal end of the body member and having a plurality of ports 22, 24, 25 connected individually to the plurality of lumens in the body member;
(c) an inflatable member 30 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 16 for receiving an inflation fluid injected into one 24 of the plurality of ports associated with the first of the plurality of lumens, the inflatable member including a plurality of pores 36 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; and
(d) an elongated, flexible, light guide member 28 having a proximal end adapted to be coupled to a source of light energy 78 and a distal end portion having a light diffusing surface 66 joined thereto, said light guide member being of a size to fit through a second of the plurality of lumens 14, allowing the light diffusing surface to be positionable within the inflatable member. 2. The light delivery system as in Claim 1 wherein said inflatable member includes means 42 for radially centering a distal end portion of the body member 12 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 44 having opposed end portions bonded to an inner surface of the inflatable member 32 at diametrically opposed locations and a centrally disposed aperture 50 in the tab for receiving the distal end portion of the catheter body member 12 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 32 that forms a spiral around the body member 12 (Fig.
4) .
5. The light delivery system as in Claim 1 and further including means 70, 72 for injecting a flushing liquid into one 22 of said plurality of ports connected to a second of the plurality of lumens 14.
6. The light delivery system as in any one of Claims 1-5 and further including means 80, 88, 90 for controllably displacing the light diffusing surface longitudinally within the distal end portion of the tubular body member 12.
7. 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.
8. The light delivery system as in any one of Claims 1-5 wherein the inflatable member is formed from an elastomer.
9. The light delivery system as in Claim 8 wherein the elastomer material is selected from the group consisting of polyurethane, latex, and silicone.
10. 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.
11. The light delivery system as in Claim 10 wherein the material is PTFE.
12. The light delivery system as in any one of Claims 1-5 wherein said plurality of pores 36 are uniformly distributed in a circumferential band whose width is about one-half of a length dimension of the inflatable member.
13. 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.
14. The light delivery system as in any one of Claims 1-5 wherein the pores are slits.
15. The light delivery system as in any one of Claims 1-5 and further including means 37 cooperating with the inflatable member 32 for inhibiting flow of blood into the inflatable member following inflation and during deflation thereof .
16. The light delivery system as in Claim 15 wherein the inhibiting means comprises at least one elastic band 37 overlying the inflatable member.
17. The light delivery system as in Claim 16 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores 36 in the inflatable member 32.
18. 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.
19. The light delivery system as in Claim 18 wherein the pores are slits formed in the inflatable member.
20. 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.
21. The light delivery system as in Claim 20 wherein the removing means includes means for increasing the flow of said fluid through- said pores .
22. The light delivery system as in any one of Claims
1-5 and further including a perfusion lumen 17 in the tubular body member for permitting blood to flow past the inflatable member 32 while it is inflated.
23. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a working lumen 14 and an inflation lumen 16 extending from a hub member 20 on the proximal end to the distal end portion thereof;
(b) an expansible, elongated, balloon member 32 coaxially disposed on and bonded to the body member 12 near the distal end portion, with the inflation lumen 16 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 36 of a predetermined size extending through a wall surface thereof for permitting a fraction of the inflation fluid to pass therethrough; and
(c) a waveguide 28 having a proximal end connectable to a source of light energy 78 and a distal end including a light diffusing member 66, the waveguide sized to fit through the working lumen 14 of the body member 12 such that the light diffusing member can be advanced into the distal end portion of the body member spanned by the balloon member.
24. The light delivery system as in Claim 23 and further including a first pump 74 coupled to the hub 20 for injecting a liquid into the inflation lumen 16.
25. The light delivery system as in Claim 24 and further including a second pump 70 coupled to the hub 20 for injecting a liquid into the working lumen 14.
26. The light delivery system as in any one of Claims 23-25 and further including means 90, 88, 86, 80 coupled to the hub and to the waveguide 28 for controlled, step-wise displacement of the light diffusing member 66 within the distal end portion of the body member 12 spanned by the balloon member 32.
27. The light delivery system as in Claim 26 wherein the distal end portion of the body member and the balloon member are light energy transmissive .
28. The light delivery system as in Claim 27 wherein the distal end portion of the catheter body member 12 and the balloon member 32 are made of materials capable of transmitting light of a predetermined wavelength with less than about a 50 percent loss.
29. The light delivery system as in Claim 28 wherein the materials are selected from a group consisting of polyethylene, FEP, PFA, PTFE, ETFE, PET, nylon, polyurethane, latex, or silicone.
30. The light delivery system as in Claim 23 and further including balloon centering means 42 for maintaining the balloon member 32 concentrically centered on the distal end portion of the catheter body member 12.
31. The light delivery system as in Claim 30 wherein the centering means comprises a flexible tab member 44 disposed within the balloon member and having first and second opposed ends bonded to the balloon member at diametrically disposed locations and an aperture 50 through the tab located midway between the first and second opposed ends, for receiving the catheter body member therethrough.
32. The light delivery system as in Claim 31 wherein said means for radially centering the distal end portion of the body member is comprised of a balloon member 32 that forms a spiral around the body member 12 (Fig. 4) .
33. The light delivery system as in Claim 23 and further including means 37 cooperating with the balloon member 32 for inhibiting flow of blood into the balloon member following inflation and during subsequent deflation thereof.
34. The light delivery system as in any one of Claims
23-25 and 27-33 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 23-25 and 27-33 wherein the pores are slits formed in the inflatable member.
36. The light delivery system as in Claim 33 wherein the inhibiting means comprises at least one elastic band 37 overlying the wall surface of the balloon member.
37. The light delivery system as in Claim 36 wherein the at least one elastic band includes a plurality of pores laterally offset from the plurality of pores 36 in the inflatable member.
38. The light delivery system as in any one of Claims 23-25 and 27-33 wherein said plurality of pores 36 are uniformly distributed in a circumferential band whose width is about one-half of a length dimension of the balloon member.
39. The light delivery system as in any one of Claims 23-25 and 27-33 wherein the size of the pores is between about 0.1 and 250 microns.
40. The light delivery system as in any one of Claims 23-25 and 27-33 wherein the pores are slits.
41. The light delivery system as in any one of Claims 23-25 and 27-33 and further including means for removing blood that may enter the balloon member.
42. The light delivery system as in Claim 41 wherein the removing means includes means for increasing the flow of said fluid through the pores.
43. The light delivery system as in Claim 23 and further including a perfusion lumen 17 in the tubular body member 12 for permitting blood to flow past the balloon member while it is inflated.
44. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a plurality of lumens 14, 16, 17 extending therebetween; (b) a hub member 20 connected to the proximal end of the body member and having a plurality of ports 22, 24, 25 connected individually to the plurality of lumens in the body member; (c) an inflatable member 30 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 16 for receiving an inflation fluid injected into one 24 of the plurality of ports associated with the first of the plurality of lumens, the inflatable member including a plurality of pores 36 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, the inflatable member 30 forming a spiral around the body member 12 for radially centering the distal end portion of the body member there within; and
(d) an elongated, flexible, light guide member 18 having a proximal end adapted to be coupled to a source of light energy 78 and a distal end portion having a light diffusing surface 66 joined thereto, said light guide member being of a size to fit through a second of the plurality of lumens 14, allowing the light diffusing surface to be positionable within the inflatable member.
45. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a plurality of lumens 14, 16, 17 extending therebetween;
(b) a hub' member 20 connected to the proximal end of the body member and having a plurality of ports 22, 24, 25 connected individually to the plurality of lumens in the body member;
(c) an inflatable member 30 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 16 for receiving an inflation fluid injected into one 24 of the plurality of ports associated with the first of the plurality of lumens, the inflatable member including a plurality of pores 36 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 78 and a distal end portion having a light diffusing surface 66 joined thereto, said light guide member being of a size to fit through a second 14 of the plurality of lumens, allowing the light diffusing surface to be positionable within the inflatable member; and
(e) means 80-90 for controllably displacing the light diffusing surface longitudinally within the distal end portion of the tubular body member.
46. The light delivery system as in Claim 45 wherein said inflatable member includes means 42 for radially centering a distal end portion of the body member there within.
47. The light delivery system as in Claim 46 wherein said means for radially centering the distal end portion of the body member comprises a flexible tab 44 having opposed end portions bonded to an inner surface of the inflatable member 32 at diametrically opposed locations and a centrally disposed aperture 50 in the tab for receiving the distal end portion of the catheter body member 12 therethrough .
48. The light delivery system as in Claim 45 and further including means 70, 72 for injecting a flushing liquid into one 22 of said plurality of ports connected to a second of the plurality of lumens 14.
49. The light delivery system as in any one of Claims 44-48 wherein the inflatable member is formed of a plastic selected from the class consisting of a polyethylene, FEP, PFA, PTFE, ETFE, PET, and nylon.
50. The light delivery system as in any one of Claims 44-48 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.
51. The light delivery system as in Claim 50 wherein the material is PTFE.
52. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising :
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a plurality of lumens 14, 16, 17 extending therebetween;
(b) a hub member 20 connected to the proximal end of the body member and having a plurality of ports 22, 24, 25 connected individually to the plurality of lumens in the body member; (c) an inflatable member 30 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 16 of the plurality of lumens for receiving an inflation fluid injected into one 24 of the plurality of ports associated with the first of the plurality of lumens, the inflatable member including a plurality of pores 36 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 28 having a proximal end adapted to be coupled to a source of light energy 78 and a distal end portion having a light diffusing surface 66 joined thereto, said light guide member being of a size to fit through a second of the plurality of lumens 18, allowing the light diffusing surface to be positionable within the inflatable member.
53. The light delivery system as in Claim 45 wherein the size of the pores is between about 0.1 and 250 microns.
54. The light delivery system as in Claim 45 wherein the pores are slits.
55. The light delivery system as in Claims 45 and further including means 37 cooperating with the inflatable member 30 for inhibiting flow of blood into the inflatable member following inflation and during deflation thereof.
56. The light delivery system as in Claim 55 wherein the inhibiting means comprises at least one elastic band 37 overlying the inflatable member.
57. The light delivery system as in Claim 56 wherein the at least one elastic band 37 includes a plurality of pores laterally offset from the plurality of pores 36 in the inflatable member 30.
58. The light delivery system as in Claim 45 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.
59. The light delivery system as in Claim 45 wherein the pores are slits formed in the inflatable member.
60. The light delivery system as in Claim 45 and further including means for removing blood that may have entered the inflatable member.
61. The light delivery system as in Claim 60 wherein the removing means includes means for increasing the flow of said fluid through said pores.
62. The light ΓÇó delivery system as in Claim 45 and further including a perfusion lumen 17 in the tubular body member for permitting blood to flow past the inflatable member 30 while it is inflated.
63. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a working lumen 14 and an inflation lumen 16 extending from a hub member 20 on the proximal end to the distal end portion thereof;
(b) an expansible, elongated, balloon member 32 coaxially disposed on and bonded to the body member 12 near the distal end portion, with the inflation lumen 16 being in fluid communication with an interior of the balloon member, the balloon member including a plurality of pores 36 of a predetermined size extending through a wall surface thereof;
(c) a waveguide 28 having a proximal end connectable to a source 78 of light energy and a distal end including a light diffusing member 66, the waveguide sized to fit through the working lumen 14 of the body member 12 such that the light diffusing member 66 can be advanced into the distal end portion of the body member spanned by the balloon member; and
(d) means 80-90 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.
64. The light delivery system as in Claim 63 and further including a first pump 74 coupled to the hub 20 for injecting a liquid into the inflation lumen 16.
65. The light delivery system as in Claim 64 and further including a second pump 70 coupled to the hub 20 for injecting a liquid into the working lumen 14.
66. The light delivery system as in Claim 63 wherein the distal end portion of the body member and the balloon member are light energy transmissive .
67. The light delivery system as in Claim 63 wherein the distal end portion of the catheter body member 12 and the balloon member 32 are made of materials capable of transmitting light of a predetermined wavelength with less than about a 50 percent loss.
68. The light delivery system as in Claim 67 wherein the materials are selected from a group consisting of polyethylene, FEP, PFA, PTFE, ETFE, PET, nylon, polyurethane, latex, or silicone.
69. The light delivery system as in Claim 63 and further including balloon centering means 44 for maintaining the balloon member 32 concentrically centered on the distal end portion of the catheter body member 12.
70. The light delivery system as in Claim 69 wherein the centering means comprises a flexible tab member 44 disposed within the balloon member and having first and second opposed ends bonded to the balloon member 32 at diametrically disposed locations and an aperture 50 through the tab located midway between the first and second opposed ends, for receiving the catheter body member 12 therethrough .
71. The light delivery system as in Claim 69 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 (Fig. 4) .
72. The light delivery system as in Claim 63 and further including means 37 cooperating with the balloon member 32 for inhibiting flow of blood into the balloon member following inflation and during subsequent deflation thereof .
73. The light delivery system as in Claim 63 wherein the plurality of pores 36 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 .
74. The light delivery system as in Claim 63 wherein the pores are slits formed in the inflatable member.
75. The light delivery system as in Claim 72 wherein the inhibiting means comprises at least one elastic band 37 overlying the wall surface of the balloon member.
76. The light delivery system as in Claim 75 wherein the at least one elastic band 37 includes a plurality of pores 48 laterally offset from the plurality of pores in the inflatable member.
77. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a working lumen 14 and an inflation lumen 16 extending from a hub member 20 on the proximal end to the distal end portion thereof;
(b) an expansible, elongated, balloon member 32 coaxially disposed on and bonded to the body member near the distal end portion, with the inflation lumen 16 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 36 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 ports associated with the inflation lumen exceeds a predetermined value; and
(c) a waveguide 28 having a proximal end connectable to a source of light' energy 78 and a distal end including a light diffusing member 66, the waveguide sized to fit through the working lumen 14 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.
78. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising: (a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a working lumen 14 and an inflation lumen 16 extending from a hub member 20 on the proximal end to the distal end portion thereof;
(b) an expansible, elongated, balloon member 32 coaxially disposed on and bonded to the body member 12 near the distal end portion, with the inflation lumen 16 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 36 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 28 having a proximal end connectable to a source of light energy 78 and a distal end including a light diffusing member 66, 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.
79. The light delivery system as in Claim 63 wherein the size of the pores is between about 0.1 and 250 microns.
80. The light delivery system as in Claim 63 wherein the pores are slits.
81. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a working lumen 14 and an inflation lumen 16 extending from a hub member 20 on the proximal end to the distal end portion thereof;
(b) an expansible, elongated, balloon member 32 coaxially disposed on and bonded to the body member 12 near the distal end portion, with the inflation lumen 16 being in fluid communication with an interior of the balloon member, the balloon member including a plurality of pores 36 of a predetermined size extending through a wall surface thereof ;
(c) a waveguide 28 having a proximal end connectable to a source of light energy 78 and a distal end including a light diffusing member 66, the waveguide sized to fit through the working lumen 14 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 for removing blood that may enter the balloon member.
82. The light delivery system as in Claim 81 wherein the removing means includes means for increasing the flow of said fluid through the pores.
83. A light delivery system for irradiating an internal surface of a blood vessel with light energy, comprising:
(a) an elongated, flexible, tubular body member 12 having a proximal end, a distal end portion and a working lumen 14 and an inflation lumen 16 extending from a hub member 20 on the proximal end to the distal end portion thereof;
(b) an expansible, elongated, balloon member 32 coaxially disposed on and bonded to the body member 12 near the distal end portion, with the inflation lumen 16 being in fluid communication with an interior of - the balloon member, the balloon member including a plurality of pores 36 of a predetermined size extending through a wall surface thereof;
(c) a waveguide 28 having a proximal end connectable to a source of light energy 78 and a distal end including a light diffusing member 66, the waveguide sized to fit through the working lumen 14 of the body member such that the light diffusing member 66 can be advanced into the distal end portion of the body member spanned by the balloon member 32;
(d) a perfusion lumen 17 in the tubular body member for permitting blood to flow past the balloon member while it is inflated.
84. A light delivery system for exposing the interior wall of a blood vessel to light energy comprising:
(a) an elongated, optical waveguide 28 adapted to be connected at a proximal end to a source of light energy 78 and having a light energy dispersing element 66 at a distal end thereof;
(b) a balloon catheter 10 having an elongated flexible plastic catheter body 12 having a proximal end, a distal end and a plurality of lumens 14, 16, 17 extending therebetween and an inflatable expander member 30 affixed to the catheter body at the distal end thereof, the expander member 30 being in fluid communication with one 16 of the plurality of lumens and the optical waveguide 28 being insertable through another 14 of the plurality of lumens, said means for flushing light absorbing substances comprising a plurality of fluid pervious pores 36 formed in the expander member 32; and
(c) means 74, 76 for flushing light absorbing substances from a zone between the energy dispersing element and the blood vessel wall at the treatment site.
85. The light delivery system as in Claim 84 and further including means 37 for inhibiting flow of blood clouded fluid through the pores 36 formed in the expander member 30 following inflation and subsequent deflation thereof.
86. The light delivery system as in Claim 84 and further including means 72, 70 for removing blood that may have entered the expander member.
87. The light delivery system as in Claim 84 wherein the elongated optical waveguide 28 comprises a fiber-optic bundle including a plurality of optical fibers 28b, 28c, 28d, said fiber optic bundle extending along said another of a plurality of lumens 14 from the proximal end to an exit port 92 formed through the catheter body 12 at a location within the inflatable expander member 30, said plurality of optical fibers being routed over an outer surface of the catheter body at radially spaced locations.
88. The light delivery catheter as in Claim 87 and further including slidable means 94 surrounding the catheter body 12 to which distal ends of the plurality of optical fibers are attached.
STATEMENT UNDER ARTICLE 19
The International Search Report found Claims 1-3, 5, 7-11, 13-15, 20, 25, 30, 33, 35 and 39-46 to be lacking in inventive step based upon the teachings of U.S. Patent 5,342,298, U.S. Patent 5,370,608 and U.S. Patent 4,799,479. No objection has been raised to Claims 4, 6, 12, 16-19, 26-29, 31, 32, 34, 36-38 and 47-49 as originally filed. The newly added Claims 44-88 comprise the allowable claims rewritten in independent form along with dependent claims that now depend from rewritten independent claims that have not been rejected.
Original independent Claims 21 and 23 have been amended to recite that a portion of the inflation fluid passes through pores in the inflatable member to flush light absorbing substances from the interface between the inflation member and the blood vessel. No such teaching is taught or suggested by the cited art . Claim 50 has been canceled pursuant to Rule 67.1 (iv) . The present slate of claims is presented and the remarks are intended to be helpful in the course of the further prosecution of the subject application.