JP2001520910A - Optical transmission system - Google Patents

Abstract

The light delivery system 10 used to illuminate vascular tissue includes a balloon catheter 12, which includes a working lumen 14 containing an optical fiber 28, and a liquid at a proximal end. And has an inflatable / floodless lumen 16 that communicates with a space formed within a balloon member 32 attached to the distal end of the catheter. The balloon member 32 has a predetermined pattern of holes or pores 36 in its wall, and a saline solution may flow through these pores when the balloon is inflated, preventing good radiant energy transfer. Flow blood or other absorbent away from the treatment area.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] The present invention relates generally to surgical instruments that improve the results of percutaneous transluminal coronary angioplasty procedures, and in particular to radiant energy, such as U.S. Pat. V. Alternatively, the present invention relates to a light delivery system including means for irradiating a treatment site with visible light and simultaneously flushing blood from an optical path. Irradiation of the treatment site has been shown to reduce the incidence of restenosis.

BACKGROUND OF THE INVENTION A method and apparatus for treating vascular tissue to minimize restenosis after angioplasty, filed Apr. 20, 1995, assigned to the assignee of the assignee of the present invention. U.S. patent application Ser. No. 08 / 425,858 discloses that the treatment site is U.S. Pat. V. Conventional examples of known methods and devices for reducing the proliferation of smooth muscle cells at the site of a stenotic lesion where balloon angioplasty has been performed by exposure to light are discussed. The system described in the above-mentioned co-pending patent application and for which proprietary rights are required, in particular, involves the relevant tissue being controlled in a controlled manner by the step-wise movement of the radiant energy emitting fiber.
. V. In the mode of irradiation with light, this is improved over the conventional example. The disclosure of the above-mentioned application No. 08 / 425,858 is incorporated herein by reference.

[0003] After angioplasty procedures, when light irradiates endothelial and intimal tissue, light or other light absorbing material is present between the light energy emitter and the tissue to be treated. Difficulties arise when delivering light of a wavelength to the treatment site with sufficient intensity. While the device disclosed in the above-mentioned co-pending patent application of Applicants' assignee is effective at clearing most blood sites due to the inflation of the balloon member against the vessel wall being treated, Even the remaining thin layer of saline contaminated with blood or blood trapped between the outside of the balloon and the blood vessels, the U.S.A. V.
Significantly reduce light transmittance. Even at 1% blood in saline 257
nm at a wavelength of nm. V. It has been found that light transmission can be reduced by 70% or more. Therefore, there is a need for an improved system that can illuminate the inner lining of a blood vessel and expose vascular tissue to radiant energy with a sufficiently high and effective intensity.

(Means for Solving the Problems) A light delivery system for suppressing restenosis by irradiating a blood vessel or the inner surface of a photocurable plastic stent with light energy has been devised. The system includes a balloon catheter having an inflatable elongated balloon member coaxially disposed and coupled to a distal end of an elongated flexible tubular plastic catheter body member. The catheter body member has a construction having an active lumen and an inflation lumen / flood lumen extending from a suitable hub assembly on the proximal end of the catheter body to the distal end of the catheter to which the balloon is attached. The inflation / flood lumen is in fluid communication with the interior of the balloon member. The balloon member includes a predetermined pattern of small pores or holes through its wall. Therefore,
Flushing fluid, such as normal saline, when injected into the port of the hub communicating with the inflation / flooding lumen, simultaneously inflates the balloon to a predetermined outer diameter and perfuses the pores of the balloon member. Flow residual blood or other light absorbing material that may be present between the surface of the balloon at the treatment site and the blood vessels. By inflating the balloon to high pressure, the stenotic lesion can be urged against the vessel wall.

In one embodiment, an optical waveguide in the form of an optical fiber or bundle of these optical fibers having a light diffusing member at the distal end thereof is provided at the distal end of a catheter body member to which a balloon having an open pore is coupled. Insert and advance the working lumen until the light diffusing member is aligned. By coupling the proximal end of the optical fiber to a suitable source of light energy, the light energy is transmitted along a single fiber or multiple fibers and, after reaching the diffuser, the radiation passes through the balloon wall. And irradiate the treatment site.

In accordance with another aspect of the invention, an additional pump may be used to perfuse the working lumen with normal saline solution and drain it from the distal end of the catheter. By maintaining a very slow, positive saline flow through the catheter, the guidewire or fiber optic can cause blood or other bodily fluids to be activated when the catheter is advanced and / or retracted through the working lumen. Effectively prevents return into the lumen. Means are also provided to prevent the fluid contaminated with blood from returning into the deflated balloon.

According to yet another embodiment, to prevent the need for frequent inflation / deflation cycles to allow blood flow to the distal end of the treatment site, according to yet another embodiment, a catheter is provided. Means are provided for perfusing the lumen with blood and draining from the tip. Multiple optical fibers comprising a fiber optic bundle can be deployed around the outside diameter of the catheter body to prevent the blood-filled lumen or channel of the catheter body from shading the vessel wall. The channel filled with blood is surrounded by the light emission reducing member.

[0008] These and other objects and advantages of the present invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiments, particularly when considered in conjunction with the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1, a light delivery system configured to apply radiant energy to the intima and endothelial tissue of an artery or a photocurable plastic stent during a balloon angioplasty procedure for a patient. Is designated by the numeral 10 in its entirety. As with the device of the aforementioned copending application Ser. No. 08 / 425,858, the system comprises an elongated, flexible tubular catheter body 12 in which the polyethylene plastic has low loss characteristics and transmits light energy of a given wavelength. The catheter body is preferably extruded from polyethylene plastic in that it has the ability to extrude.

As best seen in the cross-section of FIG. 2, the catheter body member 12 includes a plurality of lumens, including a working lumen 14, an inflation / flood lumen 16, and an optional perfusion lumen 17. At the proximal end of the catheter body 12, a molded plastic hub member 20 and a Y adapter 21 forming a plurality of side inlet ports 22, 24 are mounted. The side inlet port 22 of the Y-adapter 21 is in fluid communication with the working lumen 14 of the catheter body 12. Similarly, the side inlet port 24 of the hub member 20 is in fluid communication with the inflation / flood lumen 16. If an optional perfusion lumen 17 is provided in the catheter 12, another luer fitting 25 is provided as a means to guide the perfusate, eg, blood, into the perfusion lumen. Each of the side inlet ports includes luer fittings to allow a separate fluid source to be attached thereto, in a manner described further below.

The Y-adapter 21 includes a rotatable fitting 23 which cooperates with a Touhy-Borst type clamp or seal 52 which cooperates with the hub 20 and optical fiber 28 to prevent fluid leakage. Including. The optical fiber 28 passes through the Y adapter 21, the hub 20, and the working lumen 14 of the catheter body 12.

An inflatable expander member, generally designated 30 and comprising an inflatable balloon member 32, is suitably coupled to the outer surface of the tubular catheter body 12 and bridges the distal end thereof. As shown in FIG. 1, the balloon 32, when slightly inflated, is generally cylindrical and has opposed ends 34, as shown in FIG.
, 35, the catheter body member 12 where the balloon is coupled to the catheter body.
It is inclined to a small diameter approximating the outside diameter of.

[0013] Balloon 32 is preferably formed from a biaxially oriented polyethylene plastic material and is generally about 1.5 mils thick. Fluorinated ethylene propylene (
FEP), perfluoroalkoxy resin (PFA), polytetrafluoroethylene (PTFE) and ethylene-tetrafluoroethylene (ETFE) are also described in U.S. Pat.
V. And has desired light transmission characteristics in both ranges of visible light. Generally, 0. A band containing a plurality of small holes or pores 36 ranging in diameter from 1 to 250 microns is located slightly in the center of the cylindrical region of balloon 32. About 20 in length
In the case of a balloon having a millimeter cylindrical area, the band occupied by the plurality of pores may be centrally located without restrictions and may be about 10 millimeters long.

A flexible elastomer band 37 whose unstretched diameter is only slightly larger than the diameter of the tubular inner member 12 surrounds the expander member 30 and covers the band with pores. The elastic band 27 also includes a plurality of holes offset laterally with respect to the pores formed through the wall 32 of the expander member 30. As described in more detail below, the perforated elastic band, when contracted after the initial inflation, cooperates with the expander member as a "check valve" to provide the interior of the expander member with Prevents infiltration of saline clouded blood. The holes shown in the band 37 and the lower extending expander member 30 are shown as oval or circular, but when pressurized, expand and open to allow the saline solution to open. Fine slits can be provided that allow perfusion but have a tendency to reclose when the expander member is empty.

Openings, indicated at 38 and 40, are formed through the wall of the distal end of the tubular catheter body 12 and are bridged by the expander member 30 and these openings are
It leads to an inflation / flood lumen 16 in the catheter body.

As described in more detail below, US Pat. V. In order to more evenly expose the vessel wall to light, it may be useful to incorporate an anchoring device into the structure that maintains the distal end of the catheter body 12 midway within the expander member 30. If the tip of the catheter bends or sags, the optical path from the optical fiber to the vessel wall will be asymmetric. In order to prevent this state, an anchor structure 42 (FIG. 3) is incorporated in the expander member 30. The anchor structure may include a generally rectangular tab 44 of thin flexible plastic sheet material having its opposite ends 46-48 (FIG. 1) coupled to the inner surface of balloon member 32. A circular hole 50 through which the tubular catheter body 12 is inserted is disposed at the center of the tab 44. The tabs 44 provide the necessary support to maintain the catheter body 12 in a balanced and suspended state within the inflatable balloon member when inflated.

Another centering method is shown in FIG. In this case, the balloon 32
Since formed from a parison, the inserts in the mold used will preferably form a helical constriction to accommodate the body member 12 therethrough, thereby allowing Bellin's European Patent Application No. 0688580A1. In a manner somewhat similar to the technique disclosed in the specification, a centered spiral neck or waist 51 is formed on balloon 32.

An elongated flexible radiant energy transmitting fiber assembly 28 includes a two-high-bolst type compression fitting 52, a hub 20 and a catheter body 12.
Through the working lumen 14. The radiation source to be used is U.S.A. V. As described in the above-mentioned copending application Ser. No. 08 / 425,858 with light,
The radiant energy transferable fiber may include a core member 54 (FIG. 5) with a stainless steel outer jacket 56 formed from a thin-walled hyperdermic needlestock, surrounded by a polyimide jacket 60. Quartz fiber 58 passes through the lumen. The tip of the quartz fiber 58, designated by the numeral 62 and polished flat and held on its flat surface by shrink tubing 64, is a light diffuser 66, which in a preferred embodiment is A Teflon (registered trademark) rod having a short length, which acts on light emitted from the distal end portion 62 of the optical fiber and uniformly diffuses the light, is provided. Without the use of Teflon rods, considerable scattering of light would occur, and the assembly 28
It is not essential that this rod be included. The radiopaque marker with the tungsten plug 68 is also fixed in place by the Teflon shrink tubing 64 so that the ends of the optical waveguide can be viewed with a fluoroscope.

Having described specific aspects of the structure of the light delivery catheter of the first preferred embodiment of the present invention, the mode of operation will now be considered. In this regard, reference is made to the partial schematic diagram of FIG.

When performing an angioplasty procedure, the light delivery catheter of FIG. 1 without the light guide 28 may be inserted by inserting the proximal end of a guidewire into the distal end of the working lumen 14 of the light delivery catheter. , Sent over the guidewire. The light delivery catheter is advanced over the guidewire until the tip occupied by the expander member 30 is positioned proximate the site of the stenotic lesion to be treated during an angioplasty procedure. After the stenotic lesion is compressed in the arterial wall by inflating the balloon 32 to a predetermined pressure, the pressure may be reduced slightly, after which the guidewire may be removed and replaced with an optical fiber 28; The fiber optic is used to couple the two-high-bolst clamp 52, the tubular hub 20, and the catheter body member 12 until the radiopaque tip 68 is determined to be positioned distal to the treatment site by fluoroscopy. Is sent through.

As the light delivery catheter advances over the guidewire, the roller pump 70
To deliver normal saline solution from the supply bag 72 to the inlet port 22 on the hub 20 leading to the working lumen 14 of the catheter body member. The saline is preferably delivered at a rate of about 2 milliliters per minute, which allows blood or other light absorbing material to flow back in the opposite direction into the distal end of the working lumen of the catheter. This is a sufficient amount to prevent.

Next, by activating the positive displacement pump 74, normal saline from the supply bag 76 flows through the inlet port 24 and the inflation / floodless lumen 16 of the catheter body 12 and expands. The member 30 is inflated to a desired predetermined pressure, which can be indicated by a suitable gauge indicated at 77. When the pressure in the expander 30 exceeds the fluid pressure of the blood vessel, normal saline seeps out through the small pores 36 formed in the walls of the balloon 32 and the band 37, and the outer surface of the balloon 32 This can maintain a clear light transmission path with almost no trace of blood in the region between the abutting blood vessel surface.

The tip of the optical fiber, including the diffuser 66, to prevent the roller pump 70 from injecting saline through the working lumen 14 of the light delivery catheter and backflow blood into the tip of the catheter Reciprocates back and forth within the working lumen and passes through the quartz fiber 58 and diffuser 66 through the laser source 78.
Exposes the arterial tissue uniformly to the light emitted from the The tip of the catheter body 12 and the balloon are made of a low-loss plastic material, for example, polyethylene, FEP, PFA.
, PTFE or ETFE, and the area occupied by the expander member 30 achieves efficient delivery of light energy to the tissue to be treated because all blood traces are washed away. You.

With continued reference to FIG. 6, the reciprocating motion of the tip of the optical fiber clamps the hub 20 of the clamping fixture 80 mounted on the stationary base 82 and furthermore, as indicated by the bidirectional arrows. This is accomplished by clamping the optical fiber 28 of a movable slide member 84 along a stationary base 82. The sliding member 84 includes a traveling nut screwed into a precision lead screw 86 that can be driven to rotate by a DC stepper motor 88. The system controller module 90 includes a microprocessor (not shown) programmed to precisely control the rotation of the lead screw, and thus the movement of the diffuser member 66 along the distal end of the working lumen of the light delivery catheter body 12. In.

The system controller 90, in addition to controlling the reciprocation of the optical fiber relative to the light delivery catheter, also controls the on / off state, the energy delivered by the laser 78, the working lumen 14 of the catheter, and the inflation / flooding lumen 16. It can also be programmed to control the operation of the roller pump 70 and the positive displacement pump 74 which precisely control the amount of flushing liquid delivered through.

When the light delivery catheter assembly needs to be repositioned within a blood vessel, the expander member must first be deflated. To prevent blood clouded saline from flowing into the interior of the expander member, the elastic band shrinks upon contraction to effect a pore 36 formed through the expander member wall 32. Seal it. When exposing the tissue as desired, the expander member 30 may be extended for a long interval.
If it becomes necessary to maintain the inflated state, it may be necessary to allow blood to be perfused at the tip of the treatment site. In this case, the patient's own blood can be pumped out of the distal end of catheter 12 via port 25 and lumen 17.

The enlarged side partial cross-sectional view of FIG. 7 and the cross-sectional view of FIG. 8 show that as blood is perfused through the perfusion lumen 17 of the catheter body member 12, a shadow is formed on the tissue wall to be treated. Fig. 4 shows another embodiment of the present invention in which the prevention of the occurrence of a failure is shown. Instead of using a single optical fiber, indicated at 28 in the embodiment of FIG. 1, a bundle of optical fibers 28a is constructed such that the proximal end of the expander member 32 has the outer diameter of the tubular member 12 from its proximal end. Traverses the working lumen 14 to an outlet port 92 formed through the wall of the tubular member 12 at a point just distal to the point where it is joined to the working lumen. Optical fiber bundle 28
a is its individual optical fiber 28b, 28c, 28d covering the outer surface of the tubular member 12;
, The tip of which is attached to a sliding ring 94 that loosely surrounds the tubular member 12. When the tips of the individual optical fibers 28b, 28c, 28d are attached to the ring 94, their light emitting surfaces are properly oriented to transmit light radially. In the course of this procedure, the stepper motor pulls the proximal end of the fiber optic cable in the proximal direction, causing the ring 94 and the light emitting tips of the individual fibers 28a-28c to span the length dimension of the expander member. A corresponding translational movement illuminates the wall of the vessel to be treated according to the time / intensity profile programmed in the system controller 90.

When performing the above procedure, the blood of the patient collected before this procedure perfuses the perfusion lumen 17 of the tubular member 12, is discharged from the distal end thereof, and enters the tissue located at the distal end of the treatment site. Blood can be supplied. Because the individual fibers 28a-28c effectively surround the perfusion lumen, no shadow is formed on the tissue to be treated.

In order to comply with patent law, apply new principles to those skilled in the art, and provide the necessary information to form and use the specific parts required, the present invention is herein described. Was described in considerable detail. However, it is to be understood that the invention can be implemented with particularly different equipment and devices, and that various changes can be made in both the details of the instrument and the procedure of operation without departing from the scope of the invention. .

[Brief description of the drawings]

FIG. 1 is a partial side cross-sectional view of an optical delivery system according to one embodiment of the present invention.

FIG. 2 is a cross-sectional view taken along line 2-2 of FIG.

FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 1;

FIG. 4 is a view of a balloon including a centering member.

FIG. 5 is a longitudinal sectional view of an optical fiber used in the system of FIG. 1;

FIG. 6 is a diagram schematically showing an aspect in which the light delivery system shown in FIG. 1 is formed in use.

FIG. 7 is an illustration of another embodiment that enables perfusion of blood during use of the light delivery system.

FIG. 8 is a cross-sectional view taken along line 8-8 of FIG. 7;

──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventors Geebol, Robert, J Minnesota, Brain, United States Jefferson Street N, E, 13041 Term (reference) 4C082 PA03 PC10 PG13 PG20 PJ30 PL03

Claims (88)

[Claims] 1. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a plurality of lumens 14, 16, 17 extending therebetween.
An elongated flexible tubular body member 12 having: (b) a plurality of ports 22, 24, 25 coupled to a proximal end of the body member and each connected to a plurality of lumens of the body member. A hub member 20; (c) formed of a material substantially transmitting light of a predetermined wavelength, attached to a distal end portion of the body member, and in fluid communication with the first lumen 16 of the plurality of lumens; An inflatable member 30 for receiving inflation fluid injected into one of the ports 24 associated with one lumen, the inflatable member having a plurality of pores 36 and occupied by the inflatable member. Perfusing a portion of the inflation fluid at a rate sufficient to flush the light-absorbing material from the region within the blood vessel, and further comprising: (d) a proximal end connectable to a light energy source 78 and coupled thereto. Light diffusion surface 6
And an elongate flexible waveguide member 28 having a distal end provided with a distal end 6 that is sized to be mounted through the second lumen 14 of the plurality of lumens and includes a light diffusion source within the inflatable member. A light delivery system that can be positioned at 2. The light delivery system according to claim 1, wherein said inflatable member includes means for radially centering the distal end of the body member therein. 3. The means for radially centering the distal end of the body member includes a flexible tab 44 having opposite ends coupled to the inner surface of the inflatable member 32 at radially opposite positions. The light delivery system according to claim 2, comprising a centrally located hole (50) in the tub for receiving a distal end of the catheter body member (12). 4. The light delivery system according to claim 2, wherein the means for radially centering the distal end of the body member comprises an inflatable member forming a spiral shape about the body member. . 5. The light delivery system according to claim 1, further comprising means for injecting a flushing liquid into one of the plurality of ports connected to the second lumen of the plurality of lumens. 6. The light delivery device according to claim 1, further comprising means (80, 88, 90) for controllably moving the light diffusion surface in the longitudinal direction within the distal end portion of the tubular body member (12). system. 7. The inflatable member comprises polyethylene, FEP, PFA, P
The light delivery system according to any one of claims 1 to 5, wherein the light delivery system is formed of a plastic selected from the class consisting of TFE, ETFE, PET, and nylon. 8. The light delivery system according to claim 1, wherein the inflatable member is formed of an elastomer. 9. The light delivery system of claim 8, wherein the elastomeric material is selected from the group consisting of polyurethane, latex, and silicone. 10. The light delivery system according to claim 1, wherein at least a tip portion of the body member is formed of a material having a relatively small transmission loss of light energy of a predetermined wavelength. 11. The light delivery system according to claim 10, wherein the material is PTFE. 12. The light of claim 1, wherein the plurality of pores are evenly distributed in a circumferential band having a width that is about half the length of the inflatable member. Delivery system. 13. The light delivery system according to claim 1, wherein the size of the pore is 0.1 to 250 microns. 14. The method according to claim 1, wherein the pore is a slit.
Item 13. An optical delivery system according to Item 7. 15. The system according to claim 1, further comprising means for cooperating with the inflatable member to prevent blood from flowing into the inflatable member after inflation and during deflation.
An optical transmission system according to any one of the preceding claims. 16. The light delivery system according to claim 15, wherein the suppression means comprises at least one elastic band 37 covering the inflatable member. 17. The light delivery system of claim 16, wherein the at least one elastic band comprises a plurality of pores laterally offset from a plurality of pores of the inflatable member. 18. The method according to claim 1, wherein the plurality of pores are normally closed and open when the pressure of the fluid injected into one of the plurality of holes provided in the first lumen exceeds a predetermined value. An optical transmission system according to any one of the preceding claims. 19. The light delivery system according to claim 18, wherein the pore is a slit formed in the inflatable member. 20. The light delivery system according to claim 1, further comprising means for removing blood that has entered the inflatable member. 21. The light delivery system of claim 20, wherein the means for removing comprises means for increasing the flow of the fluid through the pore. 22. The light delivery system according to any one of claims 1 to 5, further comprising a perfusion lumen 17 within the tubular body member to allow blood to flow over the inflatable member 32 during inflation. . 23. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a working lumen extending from the hub member 20 on the proximal end to the distal end. An elongated, flexible tubular body member 12 having an inflatable elongated balloon member 32 coaxially disposed and coupled to the body member proximate the distal end; The lumen 16 is in fluid communication with the interior of the balloon member, the balloon member being inflatable by the inflation fluid injected into the inflation lumen, the balloon member having a plurality of predetermined sized pores 3 penetrating the wall thereof.
6, an inflatable elongated lumen through which a portion of the inflation fluid can pass, and (c) a proximal end connectable to a light energy source 78 and a distal end including a light diffusing member 66. A waveguide 28 sized to be attachable through the working lumen 14 of the body member 12 and the light diffusing member can be advanced into the distal end of the body member bridged by the balloon member. An optical transmission system comprising: a waveguide member; 24. The light delivery system according to claim 23, further comprising a first pump connected to the hub and for injecting liquid into the inflation lumen. 25. The light delivery system according to claim 24, further comprising a second pump connected to the hub and for injecting liquid into the working lumen. 26. A means for moving the light diffusing member 66 in a controlled step within the distal end of the body member 12 connected to the hub and the waveguide 28 and bridged by the balloon member 32. The optical delivery system according to any one of claims 23 to 25, further comprising 80. 27. The light delivery system according to claim 26, wherein the distal end of the body member and the balloon member can transmit light energy. 28. The tip of the catheter body member 12 and the balloon member 32 are capable of transmitting light of a predetermined wavelength with less than about 50 percent loss.
8. The optical transmission system according to 7. 29. Materials are polyethylene, FEP, PFA, and PTFE.
29. The light delivery system of claim 28, wherein the system is selected from the group consisting of ETFE, PET, nylon, polyurethane, latex, or silicone. 30. The light delivery system according to claim 23, further comprising a balloon centering means at the distal end of the catheter body member to maintain the balloon member coaxially centered. 31. A centering means comprising: first and second opposed ends disposed within the balloon member and coupled to the balloon member at radially disposed positions; and the first and second opposed ends. 31. The light delivery system of claim 30, further comprising a flexible tab member 44 having a hole 50 for receiving a catheter body member through the intervening tab. 32. The light delivery system (FIG. 4) of claim 31, wherein the means for radially centering the distal end of the body member comprises a balloon member 32 forming a helical shape around the body member 12. 33. The light delivery system according to claim 23, further comprising means (37) for cooperating with the balloon member (32) to prevent blood from flowing into the balloon member after inflation and during deflation. 34. The plurality of pores are normally closed, and open when the pressure of the fluid injected into one of the plurality of pores provided in the first lumen exceeds a predetermined value. 35. An optical delivery system according to any one of claims 27 to 33. 35. The light delivery system according to any one of claims 23 to 25 and 27 to 33, wherein the pore is a slit formed in the expandable member. 36. The light delivery system according to claim 33, wherein the suppression means comprises at least one elastic band 37 covering a wall surface of the balloon member. 37. The light delivery system of claim 36, wherein the at least one elastic band comprises a plurality of pores laterally offset from the plurality of pores 36 of the inflatable member. 38. The plurality of pores 36 are evenly distributed in a circumferential band having a width that is about half the length of the balloon member.
34. The optical transmission system according to any one of claims to 33. 39. The light delivery system according to any one of claims 23 to 25 and 27 to 33, wherein the size of the pore is 0.1 to 250 microns. 40. The method according to claim 23, wherein the pore is a slit.
The optical transmission system according to any one of claims 7 to 33. 41. The light delivery system of any one of claims 23 to 25 and 27 to 33, further comprising means for removing blood that may enter the balloon member. 42. The light delivery system of claim 41, wherein the means for removing comprises means for increasing the flow of the fluid through the pore. 43. The light delivery system of claim 23, further comprising a perfusion lumen 17 within the tubular body member 12 to allow blood to flow across the inflatable member during inflation. 44. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a plurality of lumens 14, 16, 17 extending therebetween.
An elongated flexible tubular body member having: (b) a hub coupled to a proximal end of the body member and having a plurality of ports 22, 24, 25 each connected to a plurality of lumens of the body member. And a member 20; (c) formed of a material substantially transmitting light of a predetermined wavelength, attached to the distal end of the body member, in fluid communication with the first lumen 16 of the plurality of lumens, and connected to the first lumen of the plurality of lumens. An inflatable member 30 for receiving inflation fluid injected into one of the ports 24 of the associated plurality of ports, the inflatable member having a plurality of pores 36 for occupying the vessel within the inflatable member; A portion of the inflation fluid is perfused at a rate sufficient to flush the light absorbing material from the region, and the inflatable member 30 has a helical shape that radially centers the distal end of the body member 12. Inflatable member 30 obtained by forming around the I member, further, the light diffusion surface 66 that is coupled thereto and linkable base end in (d) of optical energy sources 78
An elongate flexible optical waveguide member 18 having a distal end provided with a distal end, the optical waveguide member being sized to be mounted through the second lumen 14 of the plurality of lumens and having a light diffusing surface within the inflatable member. An optical waveguide member that is positionable. 45. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a plurality of lumens 14, 16, 17 extending therebetween.
An elongated flexible tubular body member 12 having: (b) a plurality of ports 22, 24, 25 coupled to a proximal end of the body member and each connected to a plurality of lumens of the body member. A hub member 20; (c) formed of a material substantially transmitting light of a predetermined wavelength, attached to a distal end portion of the body member, and in fluid communication with the first lumen 16 of the plurality of lumens, and a first lumen of the plurality of lumens. An inflatable member 30 for receiving inflation fluid injected into one of the ports 24 of the plurality of ports, the inflatable member having a plurality of pores 36 and occupying an area within the blood vessel occupied by the inflatable member. At a speed fast enough to flush the light absorbing material from
An inflation member for perfusing a portion of the inflation fluid; and (d) a proximal end connectable to a light energy source 78 and a light diffusing surface 6 coupled thereto.
And an elongated flexible optical waveguide member 28 having a distal end provided with an optical waveguide 6, the optical waveguide member sized to be mounted through the second lumen 14 of the plurality of lumens, and having a light diffusing surface within the inflatable member. And (e) means 80-90 for controllably moving the light diffusing surface longitudinally within the distal end of the tubular body member. 46. The light delivery system of claim 45, wherein the inflatable member includes means 42 for radially centering a distal end of the body member therein. 47. A means for radially centering the distal end of the body member includes a flexible tab 44 having opposed ends coupled to radially opposed locations on an inner surface of the inflatable member 32. 47. A centrally located hole 50 in said tub for receiving a distal end of the catheter body member 12 therethrough.
3. The optical transmission system according to claim 1. 48. The optical delivery system according to claim 45, further comprising means for injecting a flushing liquid into one of the plurality of ports connected to the second lumen of the plurality of lumens. 49. The inflatable member comprises polyethylene, FEP, PFA,
49. The light delivery system according to any one of claims 44 to 48, wherein the light delivery system is formed of a plastic selected from the class consisting of PTFE, ETFE, PET, and nylon. 50. The optical transmission system according to claim 44, wherein at least a tip portion of the body member is formed of a material having a relatively small transmission loss of light energy of a predetermined wavelength. 51. The light delivery system of claim 50, wherein said material is PTFE. 52. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a plurality of lumens 14, 16, 17 extending therebetween.
An elongated flexible tubular body member 12 having: (b) a plurality of ports 22, 24, 25 coupled to a proximal end of the body member and each connected to a plurality of lumens of the body member. A hub member 20; (c) formed of a material substantially transmitting light of a predetermined wavelength, attached to a distal end portion of the body member, and in fluid communication with the first lumen 16 of the plurality of lumens, and a first lumen of the plurality of lumens. An inflatable member 30 for receiving inflation fluid injected into one of the ports 24 of the plurality of ports, the inflatable member having a plurality of pores 36 thereby occupying the intravascular space occupied by the inflatable member. Perfusing a portion of the inflation fluid at a rate sufficient to flush the light-absorbing material from the region, the plurality of pores being uniformly distributed in a circumferential band having a width about half the length dimension of the inflatable member. Distributed An inflatable member are further, (d) a proximal end connectable to the light energy source 78, the light diffusion surface coupled thereto 6
6, an elongated flexible optical waveguide member 28 having a distal end, the optical waveguide member sized to be mounted through the second lumen 18 of the plurality of lumens, and for positioning the light diffusing surface within the inflatable member. A light guide system comprising: a waveguide member capable of; 53. The light delivery system of claim 45, wherein the pore size is between 0.1 and 250 microns. 54. The light delivery system according to claim 45, wherein the pore is a slit. 55. The light delivery system of claim 45, further comprising means 37 cooperating with the inflatable member 30 to inhibit blood from flowing into the inflatable member after inflation and during deflation. 56. The light delivery system of claim 55, wherein the restraining means comprises at least one elastic band 37 covering the inflatable member. 57. The light delivery system of claim 56, wherein the at least one elastic band 37 comprises a plurality of pores laterally offset from the plurality of pores 36 of the expandable member 30. 58. The method of claim 45, wherein the plurality of pores are normally closed and open when the pressure of the fluid injected into one of the plurality of ports associated with the first lumen exceeds a predetermined value. Light delivery system. 59. The light delivery system of claim 45, wherein the pore is a slit formed in the expandable member. 60. The light delivery system of claim 45, further comprising means for removing blood that has entered the inflatable member. 61. The light delivery system of claim 60, wherein the means for removing comprises means for increasing the flow of the fluid through the pore. 62. The light delivery system of claim 45, further comprising a perfusion lumen 17 within the tubular body member to allow blood to flow past the inflatable member 30 during inflation. 63. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a working lumen extending from the hub member 20 on the proximal end to the distal end. An elongated, flexible tubular body member 12 having an inflatable elongated balloon member 32 coaxially disposed and coupled to the body member 12 near the distal end; The inflation lumen 16 is in fluid communication with the interior of the balloon member, the balloon member having a plurality of pores 36 of a predetermined size penetrating the wall thereof, and (c) a light energy source 78. A waveguide 28 having a connectable proximal end and a distal end including a light diffusing member 66, the waveguide being sized to be attachable through the working lumen 14 of the body member 12. A waveguide in which the light diffusing member can advance into the distal end of the body member bridged by the balloon member; and (d) a distal end of the body member connected to the hub and the waveguide and bridged by the balloon member. Means 80-90 for moving the light diffusing member in controlled steps within the unit. 64. The light delivery system of claim 63, further comprising a first pump 74 connected to the hub 20 for injecting liquid into the inflation lumen 16. 65. The light delivery system of claim 64, further comprising a second pump connected to the hub and for injecting liquid into the working lumen. 66. The light delivery system according to claim 63, wherein the distal end portion of the body member and the balloon member can transmit light energy. 67. The distal end of the catheter body member 12 and the balloon member 32 are capable of transmitting light of a predetermined wavelength with less than about 50 percent loss.
3. The optical transmission system according to 3. 68. The material is made of polyethylene, FEP, PFA, and PTFE.
68. The light delivery system of claim 67, wherein the light delivery system is selected from the group consisting of: ETFE, PET, nylon, polyurethane, latex, or silicone. 69. The light delivery system according to claim 63, further comprising balloon centering means 44 for maintaining the balloon member 32 coaxially centered at the distal end of the catheter body member 12. 70. The centering means includes a flexible tab member 44 disposed within the balloon member and having first and second opposed ends coupled to the balloon member 32 at radially disposed locations. 70. A hole penetrating through the tab member disposed halfway between the first and second opposed ends, and the catheter body member 12 is accommodated in the hole 50. 3. The optical transmission system according to claim 1. 71. The means for radially centering the distal end of the body member comprises a balloon member forming a spiral around the body member 12.
3. The optical transmission system according to claim 1. 72. The apparatus of claim 6, further comprising means for cooperating with the balloon member 32 to inhibit blood from flowing into the balloon member after inflation and during subsequent deflation.
3. The optical transmission system according to 3. 73. The plurality of pores are normally closed and open when the pressure of the fluid injected into one of the plurality of ports provided in the first lumen exceeds a predetermined value. 63. The optical transmission system according to 63. 74. The light delivery system of claim 63, wherein the pore is a slit formed in the expandable member. 75. The light delivery system according to claim 72, wherein the suppression means includes at least one elastic band 37 covering a wall surface of the balloon member. 76. The light delivery system of claim 75, wherein the at least one elastic band 37 comprises a plurality of pores 48 laterally offset from the plurality of inflatable member pores. 77. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a working lumen extending from the hub member 20 on the proximal end to the distal end. An elongated, flexible tubular body member 12 having an inflatable elongated balloon member 32 coaxially disposed and coupled to the body member proximate the distal end; The lumen 16 is in fluid communication with the interior of the balloon member, the balloon member being inflatable by the inflation fluid injected into the inflation lumen, the balloon member having a plurality of predetermined sized pores 3 penetrating the wall thereof.
6, wherein the plurality of pores are normally closed and open when the pressure of the fluid injected into one of the plurality of ports provided in the inflation lumen exceeds a predetermined value. (C) a waveguide 28 having a proximal end connectable to a light energy source 78 and a distal end including a light diffusing member 66, the waveguide 28 comprising a working lumen 14 of the body member 12. And a waveguide formed to a size attachable therethrough, and wherein the light diffusing member can be advanced into the distal end of the body member bridged by the balloon member. 78. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a working lumen extending from the hub member 20 on the proximal end to the distal end. An elongated, flexible tubular body member 12 having an inflatable elongated balloon member 32 coaxially disposed and coupled to the body member 12 near the distal end; The inflation lumen 16 is in fluid communication with the interior of the balloon member, the balloon member being inflatable by inflation fluid injected into the inflation lumen, the balloon member having a plurality of pores 36 of a predetermined size penetrating the wall thereof. Wherein the plurality of pores comprises an elongated balloon member uniformly distributed in a circumferential band having a width about half the length of the balloon member; and (c) A waveguide 28 having a proximal end connectable to an optical energy source 78 and a distal end including a light diffusing member 66, the waveguide being sized to be attachable through the working lumen 14 of the body member 12; A waveguide wherein the diffusing member is advanceable into the distal end of the body member bridged by the balloon member. 79. The light delivery system of claim 63, wherein the pore size is between 0.1 and 250 microns. 80. The light delivery system according to claim 63, wherein the pore is a slit. 81. A light delivery system for irradiating an inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a working lumen extending from the hub member 20 on the proximal end to the distal end. An elongated, flexible tubular body member 12 having an inflatable elongated balloon member 32 coaxially disposed and coupled to the body member 12 near the distal end; The inflation lumen 16 is in fluid communication with the interior of the balloon member, the balloon member being inflatable by the inflation fluid injected into the inflation lumen, the balloon member having a plurality of pores 36 of a predetermined size penetrating the wall thereof. A waveguide 28 having an elongated balloon member comprising: (c) a proximal end connectable to a light energy source 78 and a distal end including a light diffusing member 66; A balloon member sized to be attachable through the working lumen 14 of the body member 12, wherein the light diffusing member can be advanced into the distal end of the body member bridged by the balloon member; and (d) the balloon member Means for removing blood that may enter. 82. The light delivery system of claim 81, wherein the means for removing comprises means for increasing the flow of the fluid through the pore. 83. A light delivery system for irradiating the inner surface of a blood vessel with light energy, comprising: (a) a proximal end, a distal end, and a working lumen extending from the hub member 20 on the proximal end to the distal end. An elongated, flexible tubular body member 12 having an inflatable elongated balloon member 32 coaxially disposed and coupled to the body member 12 near the distal end; The inflation lumen 16 is in fluid communication with the interior of the balloon member, the balloon member being inflatable by inflation fluid injected into the inflation lumen, the balloon member having a plurality of pores 36 of a predetermined size penetrating the wall thereof. (C) a waveguide 28 having a proximal end connectable to a light energy source 78 and a distal end including a light diffusing member 66; The waveguide is sized to be attachable through the working lumen 14 of the body member 12, the waveguide being capable of advancing the light diffusing member into the distal end of the body member bridged by the balloon member 32; A perfusion lumen 17 within the tubular body member to allow blood to flow past the balloon member. 84. A light delivery system for exposing an inner surface of a blood vessel to light energy, comprising: (a) an elongate light guide having a light energy diffusion member 66 at a distal end connectable to a light energy source 78 at a proximal end; A wave path 28; and (b) a plurality of lumens 14, 16, 17 extending between the base end and the front end and between them.
A balloon catheter 10 having an elongated flexible plastic catheter body 12 having an inflatable expander member 30 attached to the catheter body at its distal end, the expander member 30 comprising a plurality of lumens. The optical waveguide 28 is in fluid communication with the first lumen 16 and includes a plurality of other lumens 14.
Said means for flushing the light absorbing material comprises: a balloon catheter 10 comprising a plurality of fluid permeable pores 36 formed in an expander member 32; and (c) energy at the treatment site. Means for flushing the light absorbing material from the region between the dispersing member and the vessel wall. 85. The light delivery system of claim 84, further comprising means 37 for suppressing blood cloudy fluid from flowing through pores 36 formed in expander member 30 after inflation and subsequent deflation. . 86. Means 72 for removing blood entering an expander member.
85. The optical delivery system of claim 84, further comprising:. 87. The elongated optical waveguide 28 includes a plurality of optical fibers 28b and 28c.
, 28d, formed from the proximal end along the other lumen 14 of the plurality of lumens and through the catheter body 12 at a location within the inflatable expander member 30. 85. The light delivery system of claim 84, wherein the plurality of optical fibers extend to an outlet port 92 and the plurality of optical fibers extend radially spaced apart on an outer surface of the catheter body. 88. The light delivery system of claim 87, comprising slidable means 94 surrounding the catheter body 12, to which a plurality of optical fiber tips are attached.