EP1024757A1 - Systeme de projection d'un faisceau lumineux avec fonction de rin age du sang - Google Patents

Systeme de projection d'un faisceau lumineux avec fonction de rin age du sang

Info

Publication number
EP1024757A1
EP1024757A1 EP97913880A EP97913880A EP1024757A1 EP 1024757 A1 EP1024757 A1 EP 1024757A1 EP 97913880 A EP97913880 A EP 97913880A EP 97913880 A EP97913880 A EP 97913880A EP 1024757 A1 EP1024757 A1 EP 1024757A1
Authority
EP
European Patent Office
Prior art keywords
delivery system
light
light delivery
distal end
end portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97913880A
Other languages
German (de)
English (en)
Other versions
EP1024757A4 (fr
Inventor
Curtis A. Amplatz
Mark A. Rydell
Robert J. Ziebol
Michael Kasinkas
Christopher H. Porter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Illumenex Corp
Original Assignee
Illumenex Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Illumenex Corp filed Critical Illumenex Corp
Priority claimed from PCT/US1997/019667 external-priority patent/WO1999021494A1/fr
Publication of EP1024757A1 publication Critical patent/EP1024757A1/fr
Publication of EP1024757A4 publication Critical patent/EP1024757A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0658—Radiation therapy using light characterised by the wavelength of light used
    • A61N2005/0661—Radiation therapy using light characterised by the wavelength of light used ultraviolet

Definitions

  • This invention relates generally to surgical instruments for improving the outcome of percutaneous transluminal coronary angioplasty procedures, and more particularly to a light delivery system incorporating a means for irradiating a treatment site with radiant energy, e.g., U.V. or visible light, while simultaneously flushing the blood from the light path. It has been previously found that radiating the treatment site reduces the incidences of restenosis.
  • radiant energy e.g., U.V. or visible light
  • a light delivery system for irradiating an internal surface of a blood vessel or a light curable plastic stent material with light energy so as to inhibit restenosis. It comprises a balloon catheter having an expansible, elongated, balloon member coaxially disposed on and bonded to a distal end portion of an elongated, flexible, plastic tubular catheter body member.
  • the catheter body member is designed to have a working lumen and an inflation lumen/flushing lumen that extend from a suitable hub assembly on the proximal end of the catheter body to the distal end portion of the catheter where the balloon is attached.
  • the inflation/ flushing lumen is in fluid communication with the interior of the balloon member.
  • the balloon member includes a pattern of small pores or apertures that extend through the wall thereof.
  • a flushing liquid such as normal saline
  • it will simultaneously expand the balloon to a predetermined O.D. dimension and perfuse through the pores of the balloon member to flush away any residual blood or other light absorbing substances that may be present between the surface of the balloon and the blood vessel at the treatment site.
  • Inflation of the balloon to a high pressure provides the ability to force the stenotic lesion into the blood vessel wall.
  • an optical wavelength in the form of an optical fiber or a bundle of such fibers having a light diffusing element at its distal end is inserted through the working lumen and advanced there along until the light diffusing member is aligned with the distal end portion of the catheter body member on which the porous balloon is bonded.
  • a suitable source of light energy By coupling the proximal end of the optical fiber to a suitable source of light energy, it is transmitted along the fiber or fibers and, upon reaching the diffusing member, the radiation is caused to exit through the wall of the balloon and irradiate the treatment site .
  • an additional pump may be used to perfuse normal saline solution through the working lumen and out the distal end of the catheter.
  • plural optical fibers comprising a fiber-optic bundle are deployable about the outside diameter of the catheter body such that the blood-filled channel is surrounded by the light-emitting defusing elements.
  • Figure 1 is a side view, partially sectioned, of the light delivery system in accordance with one embodiment of the present invention
  • Figure 2 is a cross-sectional view taken along the lines 2-2 in Figure 1;
  • Figure 3 is a cross-sectional view taken along the line 3-3 in Figure 1;
  • Figure 4 is a view of a balloon incorporating a centering constriction
  • Figure 5 is a longitudinal sectioned view of the optical fiber used in the system of Figure 1;
  • Figure 6 illustrates schematically the manner in which the light delivery system illustrated in Figure 1 is configured when in use
  • Figure 7 depicts a view of an alternative embodiment allowing for blood perfusion during use of the light delivery system.
  • Figure 8 is a cross-section of the view taken along the line 8-8 in Figure 7.
  • a light delivery system designed to apply radiant energy to the intimal and endothelial tissue of an artery or to a light curable plastic stent in the course of balloon angioplasty procedures on a patient .
  • a light delivery system designed to apply radiant energy to the intimal and endothelial tissue of an artery or to a light curable plastic stent in the course of balloon angioplasty procedures on a patient .
  • it comprises an elongated, flexible, tubular catheter body 12 which is preferably extruded from polyethylene plastic in that polyethylene plastic exhibits low loss properties as far as its ability to transmit light energy of a predetermined wavelength therethrough.
  • the catheter body member 12 includes a plurality of lumens including a working lumen 14 and an inflation/ flushing lumen 16 and an optional perfusion lumen 17.
  • Attached to the proximal end of» the catheter body 12 is a molded plastic hub member 20 and a Y-adapter 21 defining a plurality of side entry ports 22 and 24.
  • the side entry port 22 on Y-adapter 21 is in fluid communication with the working lumen 14 of the catheter body 12.
  • the side entry port 24 on hub member 20 is in fluid communication with the inflation/flushing lumen 16.
  • a further Luer fitting 25 is provided as a way of introducing a perfusate, e.g. blood, into the perfusion lumen.
  • a perfusate e.g. blood
  • Each of the side entry ports includes a Luer fitting, allowing attachment of separate fluid sources thereto in a manner that will be further explained hereinbelow.
  • the Y-adapter 21 includes a rotatable fitting 23 cooperating with the hub 20 and a Touhy-Borst type clamp or seal 52 that cooperates with an optical fiber 28 to preclude fluid leakage.
  • the optical fiber 28 extends through the Y-adapter 21 and the hub 20 and through the working lumen 14 of the catheter body 12.
  • an inflatable expander member indicated generally by numeral 30 and comprised of an expansible balloon member 32.
  • the balloon 32 is generally cylindrical when inflated, such as is shown in Figure 1, and it tapers at opposed ends 34, 35 to a lesser diameter, approximately that of the outside diameter of the catheter body member 12 where the balloon becomes bonded to the catheter body.
  • the balloon 32 is preferably made from a biaxially oriented polyethylene plastic material and would typically be about 1.5 mils thick. Balloons fabricated from fluorinated ethylene propylene (FEP) , perfluoroalkoxy resin (PFA) , polytetrafluoroethylene (PTFE) , and ethylene- tetrafluoroethylene (ETFE) also exhibit desirable light transmissive properties in both.the U.V. and visible light range. Located somewhat centrally in the cylindrical zone of the balloon 32 is a band containing a plurality of tiny apertures or pores 36, typically in a range of from 0.1 to 250 microns in diameter. Without limitation, for a balloon having a cylindrical zone approximately 20 millimeters in length, the band occupied by the plurality of pores may be centrally located and approximately 10 millimeters long.
  • FEP fluorinated ethylene propylene
  • PFA perfluoroalkoxy resin
  • PTFE polytetrafluoroethylene
  • ETFE ethylene-
  • a compliant elastomeric band 37 Surrounding the expander member 30 and overlaying the porous band is a compliant elastomeric band 37 whose unstretched diameter is only slightly greater than the diameter of the tubular inner member 12.
  • the elastic band 27 also includes a plurality of apertures that are laterally offset relative to the pores 36 formed through the wall 32 of the expander member 30.
  • the perforated elastic band cooperates with the expander member during deflation thereof following initial inflation as a "check valve" to prevent infiltration of blood clouded saline into the interior of the expander member.
  • apertures illustrated in the band 37 and in the underlying expander member 30 are illustrated as oval shaped or round, they may also comprise fine slits that will distend and open when pressurized to allow perfusion of saline therethrough, but which tend to reclose upon evacuation of the expander member.
  • openings as at 38 and 40 which lead to the inflation/flushing lumen 16 in the catheter body .
  • the anchoring structure may comprise a generally rectangular tab 44 of a thin flexible plastic sheet material having its opposed ends 46- 48 (Fig. 1) bonded to the inside surface of the balloon member 32. Formed centrally in the tab 44 is a circular aperture 50 through which the distal end portion of the tubular catheter body 12 may pass.
  • the tab 44 provides the requisite support for maintaining the catheter body 12 symmetrically suspended within the confines of the expansible balloon members when inflated.
  • FIG. 4 An alternative centering approach is illustrated in Figure 4.
  • an insert in the mold employed imparts a constriction, preferably spiral in shape, to create a central spiraled neck or waist 51 in the balloon 32 for receiving the body member 12 therethrough and thereby centering same along the longitudinal axis of the body member 12 in a way somewhat similar to the technique disclosed in the Verin European Application 0,688,580 Al .
  • the radiant energy transmissive fiber may include a core member 54 ( Figure 5) comprising an outer stainless steel jacket 56 formed from a thin-wall hyperdermic needle stock and extending through the lumen thereof is a quartz fiber 58 which is surrounded by a polyimide jacket 60.
  • the distal end of the quartz fiber 58 is polished flat and held against its flat face, by means of shrink tubing 64, is a light diffuser 66 which, in the preferred embodiment, comprises a short length of Teflon ® rod, which acts upon the light emanating from the distal end 62 of the light fiber to uniformly diffuse the light. In that considerable scattering of the light takes place without using the Teflon rod, it is not essential that the assembly 28 include such rod.
  • a radiopaque marker comprising a tungsten plug 68 is also secured in place by the Teflon shrink tubing 64 so that the end of the light guide may be viewed fluoroscopically.
  • the light delivery catheter of Figure 1 In performing the angioplasty treatment, the light delivery catheter of Figure 1, absent the light guide 28, is fed over a guide wire by inserting the proximal end of the guide wire into the distal end of the working lumen 14 of the light delivery catheter. The light delivery catheter is advanced over the guide wire until the distal end portion occupied by the expander member 30 is located adjacent the site of the stenotic lesion to be treated during the angioplasty procedure.
  • a roller pump 70 may be turned on to deliver a normal saline solution from a supply bag 72 to the inlet port 22 on the hub 20 leading to the working lumen 14 of the catheter body member.
  • Saline is preferably delivered at a rate of about 2 milliters per minute which is an amount sufficient to insure that blood or other light absorbing substances will not flow back into the distal end of the working lumen of the catheter in a retrograde direction.
  • normal saline from a supply bag 76 flows through the inlet port 24 and the inflation/flushing lumen 16 in the catheter body 12 to inflate the expander member 30 to a desired predetermined pressure which may be indicated by a suitable gauge, as at 77.
  • a suitable gauge as at 77.
  • the normal saline can exude out through the tiny pores 36 formed in the wall of the balloon 32 and the band 37 to maintain a clear light transmission path essentially free of even trace amounts of blood in the zone between the exterior surface of balloon 32 and the surface of the blood vessel which it abuts.
  • the roller pump 70 continues to inject saline through the working lumen 14 of the light delivery catheter to prevent back flow of blood into the distal end of the catheter, the distal end portion of the optical fiber, including the diffuser 66, is moved reciprocally back and forth within the confines of the working lumen to provide a uniform exposure of the arterial tissue to the light transmitted from a laser source 78 through the quartz fiber 58 and the diffuser 66.
  • distal end portion of the catheter body 12 as well as the balloon are fabricated from a low-loss plastic material, e.g., polyethylene, FEP, PFA, PTFE or ETFE, and because the zone occupied by the expander member 30 has been flushed clear of all blood traces, efficient delivery of light energy to the tissue to be treated is achieved.
  • a low-loss plastic material e.g., polyethylene, FEP, PFA, PTFE or ETFE
  • the reciprocal movement of the distal end of the optical fiber is achieved by clamping the hub 20 in a clamping fixture 80 affixed to a stationary base 82 and by clamping the optical fiber 28 in a slide member 84 which is movable along the stationary base 82 as indicated by the double-headed arrow.
  • the slide member 84 comprises a traveling nut that is threaded onto a precision lead screw 86 which is adapted to be rotationally driven by a DC stepper motor 88.
  • a system controller module 90 includes a microprocessor (not shown) that is programmed to precisely control the rotation of the lead screw and, therefore, the displacement of the diffuser member 66 along the distal end portion of the working lumen of the light delivery catheter body 12.
  • system controller 90 may also be programmed to control the on/off state and the energy delivered by the laser 78 as well as the running of the roller pump 70 and positive displacement pump 74 for precisely controlling the amount of flushing liquid delivered through the working lumen 14 and the inflation/flushing lumen 16 of the catheter.
  • the expander member When it is necessary to reposition the light delivery catheter assembly within a blood vessel, the expander member must first be deflated. To prevent influx of blood- clouded saline into the interior of the expander member, the elastic band contracts with the deflation to effectively seal the pores 36 formed through the wall 32 of the expander member. In the event it becomes necessary to maintain the expander member 30 inflated for prolonged intervals in providing the desired tissue exposure, it may be necessary to permit blood to be perfused distal of the treatment site. In this event, the patient's own blood can be pumped via port 25 and the lumen 17 out the distal end of the catheter 12.
  • FIG. 7 and the cross-sectional view of Figure 8 illustrate an alternative embodiment of the invention where provision is made to avoid creating a shadow on the tissue wall to be treated when blood is being perfused through the perfusion lumen 17 of the catheter body member 12.
  • a fiber-optic bundle 28a is made to traverse the working lumen 14 from its proximal end to an exit port 92 formed through the wall of the tubular member 12 at a location immediately distal of where the proximal end of the expander member 32 is bonded to the O.D. of the tubular member 12.
  • the fiber-optic bundle 28a has its individual optical fibers 28b, 28c and 28d routed over the exterior surface of the tubular member 12 and the distal ends thereof are affixed to a slide ring 94 loosely surrounding the tubular member 12. In attaching the distal ends of the individual optical fibers 28b, 28c and 28d to the ring 94, the light-emitting surfaces thereof are appropriately directed to transmit light in the radial direction.
  • the stepper motor can be controlled so as to pull the proximal end of the fiber- optic cable in the proximal direction and thereby cause a corresponding translation of the ring 94 and the light- emitting distal ends of the individual fibers 28a - 28c across the length dimension of the expander member and thereby illuminate the wall surfaces of the vessel being treated in accordance with a time/intensity profile programmed into the system controller 90.
  • the patient's blood collected prior to the procedure, can be perfused through the perfusion lumen 17 of the tubular member 12 and out the distal end thereof to provide a blood supply to tissue located distally of the treatment site. Because the individual optical fibers 28b - 28d effectively surround the perfusion lumen, no shadow thereof will be cast on the tissue to be treated.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

Ce système (10) de projection d'un faisceau lumineux, qui sert à irradier les tissus vasculaires, comprend un cathéter à ballonnet (12) pourvu d'un passage de travail (14) destiné à recevoir une fibre optique (28) et d'un passage de gonflage/rinçage (16) destiné à recevoir un liquide au niveau d'une extrémité proximale et débouchant dans un espace délimité à l'intérieur du ballonnet (32) fixé à l'extrémité distale du cathéter. Le ballonnet (32) comporte dans sa paroi un alignement de trous ou de pores (36), à travers lesquels peut s'écouler la solution saline, lorsque le ballonnet est gonflé, de sorte que le sang ou toute autre substance absorbante qui pourrait gêner une bonne transmission de l'énergie rayonnante est évacué par rinçage de la zone de traitement.
EP97913880A 1997-10-27 1997-10-27 Systeme de projection d'un faisceau lumineux avec fonction de rin age du sang Withdrawn EP1024757A4 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1997/019667 WO1999021494A1 (fr) 1996-08-26 1997-10-27 Systeme de projection d'un faisceau lumineux avec fonction de rinçage du sang

Publications (2)

Publication Number Publication Date
EP1024757A1 true EP1024757A1 (fr) 2000-08-09
EP1024757A4 EP1024757A4 (fr) 2001-08-29

Family

ID=22261967

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97913880A Withdrawn EP1024757A4 (fr) 1997-10-27 1997-10-27 Systeme de projection d'un faisceau lumineux avec fonction de rin age du sang

Country Status (4)

Country Link
EP (1) EP1024757A4 (fr)
JP (1) JP2001520910A (fr)
AU (1) AU736989B2 (fr)
CA (1) CA2307654A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10898330B2 (en) 2017-03-28 2021-01-26 Edwards Lifesciences Corporation Positioning, deploying, and retrieving implantable devices

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9694121B2 (en) 1999-08-09 2017-07-04 Cardiokinetix, Inc. Systems and methods for improving cardiac function
US10307147B2 (en) 1999-08-09 2019-06-04 Edwards Lifesciences Corporation System for improving cardiac function by sealing a partitioning membrane within a ventricle
US8388672B2 (en) 1999-08-09 2013-03-05 Cardiokinetix, Inc. System for improving cardiac function by sealing a partitioning membrane within a ventricle
US8246671B2 (en) 1999-08-09 2012-08-21 Cardiokinetix, Inc. Retrievable cardiac devices
US8529430B2 (en) 2002-08-01 2013-09-10 Cardiokinetix, Inc. Therapeutic methods and devices following myocardial infarction
US9332993B2 (en) 2004-08-05 2016-05-10 Cardiokinetix, Inc. Devices and methods for delivering an endocardial device
US9078660B2 (en) 2000-08-09 2015-07-14 Cardiokinetix, Inc. Devices and methods for delivering an endocardial device
US20060030881A1 (en) * 2004-08-05 2006-02-09 Cardiokinetix, Inc. Ventricular partitioning device
US10064696B2 (en) 2000-08-09 2018-09-04 Edwards Lifesciences Corporation Devices and methods for delivering an endocardial device
US9332992B2 (en) 2004-08-05 2016-05-10 Cardiokinetix, Inc. Method for making a laminar ventricular partitioning device
JP5875986B2 (ja) 2009-10-26 2016-03-02 カーディオキネティックス・インコーポレイテッドＣａｒｄｉｏｋｉｎｅｔｉｘ， Ｉｎｃ． 心室容積縮小
CN106852115A (zh) 2014-09-28 2017-06-13 卡迪欧凯尼迪克斯公司 用于治疗心功能不全的装置

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4799479A (en) * 1984-10-24 1989-01-24 The Beth Israel Hospital Association Method and apparatus for angioplasty
EP0311458A2 (fr) * 1987-10-08 1989-04-12 The Beth Israel Hospital Association Cathéter à laser muni d'un ballon
US5514707A (en) * 1992-12-24 1996-05-07 Yale University Inhibition of smooth muscle cell proliferation by 8-methoxypsoralen photoactivated by visible light

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5342298A (en) * 1992-07-31 1994-08-30 Advanced Cardiovascular Systems, Inc. Automated fluid pressure control system
US5417653A (en) * 1993-01-21 1995-05-23 Sahota; Harvinder Method for minimizing restenosis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4799479A (en) * 1984-10-24 1989-01-24 The Beth Israel Hospital Association Method and apparatus for angioplasty
EP0311458A2 (fr) * 1987-10-08 1989-04-12 The Beth Israel Hospital Association Cathéter à laser muni d'un ballon
US5514707A (en) * 1992-12-24 1996-05-07 Yale University Inhibition of smooth muscle cell proliferation by 8-methoxypsoralen photoactivated by visible light

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9921494A1 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10898330B2 (en) 2017-03-28 2021-01-26 Edwards Lifesciences Corporation Positioning, deploying, and retrieving implantable devices

Also Published As

Publication number Publication date
JP2001520910A (ja) 2001-11-06
AU5095898A (en) 1999-05-17
EP1024757A4 (fr) 2001-08-29
CA2307654A1 (fr) 1999-05-06
AU736989B2 (en) 2001-08-09

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