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WO1988007841A1 - Procede et appareil permettant l'angiochirurgie au laser - Google Patents

Procede et appareil permettant l'angiochirurgie au laser Download PDF

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Publication number
WO1988007841A1
WO1988007841A1 PCT/US1988/001210 US8801210W WO8807841A1 WO 1988007841 A1 WO1988007841 A1 WO 1988007841A1 US 8801210 W US8801210 W US 8801210W WO 8807841 A1 WO8807841 A1 WO 8807841A1
Authority
WO
WIPO (PCT)
Prior art keywords
thrombus
plaque
laser
catheter
gelatinized
Prior art date
Application number
PCT/US1988/001210
Other languages
English (en)
Inventor
Xiu-Bing Wei
Xuan-Yuan Wang
Sow-Hsin Chen
Original Assignee
Massachusetts Institute Of Technology
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 Massachusetts Institute Of Technology filed Critical Massachusetts Institute Of Technology
Publication of WO1988007841A1 publication Critical patent/WO1988007841A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/24—Coupling light guides
    • G02B6/42—Coupling light guides with opto-electronic elements
    • G02B6/4296—Coupling light guides with opto-electronic elements coupling with sources of high radiant energy, e.g. high power lasers, high temperature light sources
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22085—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance light-absorbing

Definitions

  • Abela et al. (G. Abela, D. Cohen, R.L. Feldman, S. Norman, R.C. Conti, C.J. Pping, "Use of Laser Radiation to Recanalize Stenosed Arteries in Living Rabbits", Clin. Res. 31:2, Abstract 458A, 1983) reported perforation in three of eight rabbit arteries treated with argon or Nd:YAG laser radiation and Sanborn et al. (T.A. Sanborn, D.P. Faxon, C.C. Haudenshchild, S.B. Gottsman, T. ' J. Ryan, "Angiographic and Histopathologic Consequences of in Vivo Laser Radiation of Atherosclerotic Lesions", Am. Heart Assoc. 56th Scientific Sessions, Abstract 577, 1983) experienced perforation in three of twelve rabbit iliac arteries treated with the argon laser.
  • Gessman et al. found an absence of filterable debris after laser treatment of a single cadaver coronary artery.
  • Case et al. R.B. Case, D.S.J. Choy, E.M. Dwyer, P.J. Silvernail, "Absence of Distal Embolization During In Vivo Laser Recanalization", Lasers Surg. Med.
  • HPD hematoporphyrin and its derivatives
  • plaque destruction following HPD photoactivation may be limited to the cellular fibrous capsule that commonly surrounds an acellular lipid-rich material within a fibrous plaque,-the latter being the most common lesion associated with clinical events >.
  • a method and apparatus is described for the liquification of plaque and/or thrombus in the blood carrying body vessels of humans and/or animals.
  • the thrombus is located by well known means, such as, X-ray or magnetic resonance imaging.
  • a light absorbing, or photosensitizing dye, such as HPD, is injected into arteries containing the thrombus/plaque.
  • a catheter is provided having optical fiber(s) contained therein with the fiber(s) coupled at the proximal end to a source of relatively low power pulsed (repetition rate 5 KHz) laser energy having a wavelength centered at secondary or tertiary absorption peak of both the plaque/thrombus and the photosensitizer.
  • the tertiary peak occurs at about 578 nanometers.
  • the catheter is inserted into the vessel until the distal end(s) of the fiber(s) are closely adjacent to the cite of the thrombus/plaque.
  • the thrombus is irradiated with the laser energy of
  • the thrombus gels in about 1 to 2 minutes with observable small bubbles appearing in the clot.
  • a thrombolytic enzyme such as, urokinase, or equivalent, is infused into the vessel to dissolve the gelatinized thrombus and the liquified material is removed by suction.
  • HPD treated plaque is dissolved by irradiating it with laser energy from a catheter while simultaneously flowing a non-toxic detergent at the plaque.
  • the wavelength of the laser energy may be at 510 nm or 578 nm, but preferably, both wavelengths are used concurrently to achieve rapid dissolution of the plaque at low power levels.
  • the average power level of the laser radiation applied to the plaque using both 510 nm and 578 nm, simultaneously, is 1.5 w.
  • the power density is about 2 to 10
  • the radiation is applied for a duration of about 1 to 5 minutes, depending upon the size of the plaque. At these power levels, very little thermal heating of the plaque or surrounding tissue occurs, thereby minimizing the danger of perforation of vessels.
  • the tissue temperature is preferably not elevated more than 1 or 2°C and should not be allowed to rise more than 7°C.
  • a solution of a non-ionic detergent such as, Triton X-100 of 2% concentration is injected, or circulated,, through the catheter into the artery or vessel to the site of the plaque.
  • Triton X-100 is a non-toxic detergent, which serves to dissolve the fat particles in the clot.
  • the injection of suitable non-toxic detergent helps to dissolve protein and lipid aggregates in the clot during the irradiation.
  • the solution of 2% detergent in water may be cooled or kept at ambient to assist in maintaining body tissue around the site of the plaque at a relatively low temperature during irradiation; thus, further minimizing the potential for thermal damage or injury to healthy tissue.
  • Fig. 1 is a block diagram of the optics system of the invention.
  • Fig. 2 is a cross-sectional schematic view of various catheter embodiments useful for the process of the invention.
  • Fig. 3 is a plot of theoretical photoreaction yield ( X ) versus depth of penetration "d" in mm for different wavelengths.
  • Fig. 4 is a plot of absorption versus wavelength for human blood.
  • Fig. 5 is a plot of absorption versus wavelength for HPD in saline.
  • Fig. 6 is a plot of absorption versus wavelength for an experimental thrombus column.
  • the thrombi was subjected to a controlled thermal injury using laser irradiation from a 578 nm line of copper vapor laser source.
  • the radius of the direct beam measured at the surface of the thrombus was 1.55 mm.
  • the power distribution across the beam follows that of a normal Gaussian curve.
  • a power level of 1 W was used to determine the duration (in seconds) required to completely penetrate the thrombus.
  • the power output from the laser source was monitored by an external power meter.
  • the apparatus of the invention comprises a laser source coupled to a suitable catheter and an attenuator, each of which is described below in connection with Figs. 1 and 2.
  • Fiber 14 is mounted on supports 16 and 18.
  • the laser beam 17 is focused onto the end surface of an optical fiber 14 by a lens 15.
  • the laser light is almost a parallel beam, therefore, covering of any fraction of the laser beam does not displace the focal point at the end of the optical fiber. Consequently, the output light at the output end of the optical fiber just changes linearly with the area of the aperture.
  • Table 2 reproduces data concerning the output intensity of 578 nm line as a function of the aperture of the iris.
  • An optical fiber catheter 22 is used to transport the laser light from fiber 14 to a thrombus (not shown) in a blood vessel.
  • Catheter 22 serves as a chemical transporter for the enzyme solution, which is injected through the catheter into the vessel.
  • the catheter also transports the unwanted products of the liqui-fied thrombus from the vessel, which is sucked out by a suction tube coupled to the catheter.
  • the simplest catheter may consist of an outer sheath 34 within which is disposed one single optical fiber 30 of 0.6 mm and one suction tube 32 of 0.4 mm, which also functions as an injection tube (See Fig. 2a) . In order to increase the speed of suction, one would like to use a considerably larger diameter suction tube (1 mm diameter) . Figs.
  • a two-stage coupling is used to couple the laser energy to a single fiber 14 and then to a fiber bundle within catheter 22.
  • the second coupling 20 connects the single fiber 14 with the adjacent fiber bundle in catheter 22.
  • the advantage of this construction is that the divergent light from the first fiber 14 falls gently on the second fiber bundle, rather than focusing on a point. This avoids burning of the surface of the second fiber bundle.
  • Blood withdrawn from normal human volunteers was immediately placed into a glass tube and allowed to mix with thrombin (15 NIH units/ml of blood) and with HPD (0.008 cc HPD/cc blood). Then, the blood was injected into vessel-like experimental tubes and refrigerated overnight for 15 to 20 hours. Forty samples of thrombi were measured, each with lengths varying from 10 mm to 30 mm.
  • a sequence of irradiation for t- seconds, followed by enzyme circulation for t_ seconds, and a subsequent suction for t_ seconds, is recommended.
  • the catheter should be moved further into the vessel and the same steps repeated, until the blood vessel is completely recanalized.
  • Typical time periods for t , t_ and t_ are 3 seconds, 30 seconds, and 2 seconds, at a power density of about 1 Joule per mm 2, repeated after removal of about 5 mm length of thrombus.
  • Table 3 shows the data at the condition of 1 mm spacing between the thermocouple tip and the surface of the thrombus and 4 mm distance between the optical fiber tip and the surface of the thrombus.
  • the temperature resolution is O.l.C.
  • a thermocouple with a 0.5 mm diameter tip was used to measure the temperature within the thrombus.
  • the thrombus With an argon laser, the thrombus is readily vaporized using 5 W of output power at 488 nm. Most of the energy, in this instance, is required to produce vaporization, and as a result, it raises the local temperature of the thrombus to above 100 ⁇ C.
  • HPD has been reported by a number of investigators to be preferentially retained in tumors and atherosclerotic plaque (Radi Macruz, Ma'rcio P. Riberio, Jose'Mauro G. Brum, Carlos Augusto Pasqualucci, Jaime Mnitentag, Dimitrios G. Bozinis, Euclydes Marques, Adib Domingos Jatene, Luiz V. De'court, Egas Armelin, "Laser Surgery in Enclosed Spaces: A Review", Lasers in Surgery and Medicine, 5.199-218, 1985; T.J.
  • HPD exhibits the characteristic aetio-absorption of porphyrins with a major absorption band near 400 nm and four minor bands of decreasing magnitude at 507 nm, 540 nm, 573 nm, and 624 nm (Daniel R. Doiron, Lars. O. Svaasand, and A. Edward Profio, "Light Dosimetry in Tissue: Application to the Photoradiation Therapy", Advances in Experimental Medicine and Biology, 160:63-76, 1983, Plenum Press).
  • the greatest tissue penetration and least absorption by HPD occur at 624 nm, and the least tissue penetration and highest HPD absorption occurs at 402 nm.
  • a laser line at 578 nm was chosen, because compared to that at 488 nm, it has a suitable rate of penetration and absorption in thrombus.
  • the cytocidal mechanism of HPD is believed to be due to a photodyna ic reaction involving oxidation of tissue via porphyrin-catalized production of singlet oxygen (H. Kato, C. Konaka, J. Ono, Y. Matsushima, K. Nishimiya, J. Lay, H. Sawa, H. Shinohara, T. Saito, K. Kinoshita, T. Tomono, M. Aida and Y. Hayata, "Effectiveness of HPD . and Radiation Therapy in Lung Cancer", Advances in Experimental Medicine and Biology, 160:23-40, 1983, Plenum Press, New York) . This phenomena was also observed in our experiments.
  • the energy density of the CVL 578 nm line required for the liquifaction of a 10 mm long thrombus was 1 +- 0.2 J/mm2; and for 12 mm clots, it was 2 - 0.3 J/mm 2 and for 15-30 mm clots, 6 - 0.4 J/mm 2 .
  • the radiation dose of CVL at 578 nm for liquification is much smaller than required for an argon laser at 488 nm and 514 nm lines.
  • the 488 nm line is so heavily attenuated by the blood, that its effectiveness is only superficial. At depths greater than 7 mm, the 578 mm light yield is much greater (See Fig. 3) .
  • the combined action of HDP, the copper vapor laser at 578 nm and the urokinase infusion is shown to be effective in the treatment of occluded vessels/arteries with thrombus.
  • Complete patency in 10 mm to 20 mm thrombus occurred after 3 seconds of laser irradia- tion at power density of 6 Joule/mm , followed by a 5 second urokinase (10,000 U/cc) infusion and suction.
  • the temperature increase inside the vessels, 2 seconds after 1 W irradiation, is between l ⁇ C and 2°C. There is no apparent change of the vessel wall from irradiation.
  • the temperature increase inside the vessels is 50 times less than all the other reports.
  • the major effect of the CVL irradiation is the liquifaction/geletanization of the thrombus. Since plaque is formed of material similar to thrombus, the data supplied herein, with respect to thrombus and the method and apparatus herein, is intended to apply equally to either thrombus or plaque. More recently, we have found that the combination of irradiation at a wavelength of 510 nanometers and 578 nanometers in the presence of a non-toxic ionic detergent solution is useful for dissolving HPD treated plaque at low power levels.
  • Circulating the detergent past or around the plaque site aids in maintaining the surrounding tissue at ambient temperature and helps to dissolve the plaque. While irradiation at 510 nm or 578 nm is useful, we have found, experimentally, that use of the laser, described above at page 11, which emits both 578 nm and 510 nm radiation, simultaneously, when combined with a circulating detergent, gives superior results. Such results include dissolving of plaque at low power levels in short time periods without damage to tissue.
  • a suitable detergent to aid in dissolving the HPD treated, irradiated plaque is a polyethoxy-type non-ionic detergent, such as TRITON X-100 surfactant.
  • TRITON is a trademark for surfactants based on alkyl-aryl polyether alcohols, sulfanates and sulfates
  • the equipment and process is the same as that above-described for thrombus removal, except that an anzyme inj ' ection is not required.
  • the enzyme injection means may therefore be used to inject and circulate the detergent solut. .n at the same time the copper vapor laser 10 produces energy at both 510 nm and 578 nm. This energy is coupled to the plaque through catheter 14/22.
  • Photo-sensitizer means 40 and suction means 44 are shown in Fig. 1 as also preferably coupled through the single catheter 14/22 through passages provided as in Fig. 2. Separate catheters for each treatment may be supplied in the alternate. Equivalents

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  • Health & Medical Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

Procédé et appareil permettant de traiter les artères bouchées par des caillots sanguins ou plaques, par application d'énergie afin de sensibiliser les occlusions, jusqu'à ce que l'occlusion soit gélatinée et jusqu'à élimination de l'occlusion gélatinée par aspiration.
PCT/US1988/001210 1987-04-13 1988-04-12 Procede et appareil permettant l'angiochirurgie au laser WO1988007841A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US3755287A 1987-04-13 1987-04-13
US037,552 1987-04-13
US11000087A 1987-10-19 1987-10-19
US110,000 1987-10-19

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WO1988007841A1 true WO1988007841A1 (fr) 1988-10-20

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990002537A1 (fr) * 1988-09-13 1990-03-22 Carl-Zeiss-Stiftung Handelnd Als Carl Zeiss Dispositif pour pratiquer de la chirurgie au laser sur des tissus biologiques
EP0528869A4 (fr) * 1990-05-17 1994-03-24 Univ Wayne State Procede de traitement d'une paroi arterielle lesee lors d'une angioplastie.
WO1995028135A1 (fr) * 1994-04-14 1995-10-26 Laser Biotech, Inc. Appareil de traitement du collagene
US5505726A (en) * 1994-03-21 1996-04-09 Dusa Pharmaceuticals, Inc. Article of manufacture for the photodynamic therapy of dermal lesion
US5709676A (en) * 1990-02-14 1998-01-20 Alt; Eckhard Synergistic treatment of stenosed blood vessels using shock waves and dissolving medication
WO1998008123A1 (fr) * 1996-08-19 1998-02-26 Cogent Light Technologies, Inc. Dispositif et procede servant a coupler de la lumiere a intensite elevee vers l'interieur d'une fibre optique a basse temperature

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0189329A2 (fr) * 1985-01-25 1986-07-30 Robert E. Fischell Système de cathéter à perforation pour angioplastie artérielle transvasculaire
EP0217165A1 (fr) * 1985-09-05 1987-04-08 Pillco Limited Partnership Appareil pour le traitement au laser de lumens des vaisseaux du corps

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0189329A2 (fr) * 1985-01-25 1986-07-30 Robert E. Fischell Système de cathéter à perforation pour angioplastie artérielle transvasculaire
EP0217165A1 (fr) * 1985-09-05 1987-04-08 Pillco Limited Partnership Appareil pour le traitement au laser de lumens des vaisseaux du corps

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1990002537A1 (fr) * 1988-09-13 1990-03-22 Carl-Zeiss-Stiftung Handelnd Als Carl Zeiss Dispositif pour pratiquer de la chirurgie au laser sur des tissus biologiques
US5123902A (en) * 1988-09-13 1992-06-23 Carl-Zeiss-Stiftung Method and apparatus for performing surgery on tissue wherein a laser beam is applied to the tissue
US5709676A (en) * 1990-02-14 1998-01-20 Alt; Eckhard Synergistic treatment of stenosed blood vessels using shock waves and dissolving medication
EP0528869A4 (fr) * 1990-05-17 1994-03-24 Univ Wayne State Procede de traitement d'une paroi arterielle lesee lors d'une angioplastie.
US5505726A (en) * 1994-03-21 1996-04-09 Dusa Pharmaceuticals, Inc. Article of manufacture for the photodynamic therapy of dermal lesion
WO1995028135A1 (fr) * 1994-04-14 1995-10-26 Laser Biotech, Inc. Appareil de traitement du collagene
WO1998008123A1 (fr) * 1996-08-19 1998-02-26 Cogent Light Technologies, Inc. Dispositif et procede servant a coupler de la lumiere a intensite elevee vers l'interieur d'une fibre optique a basse temperature

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