EP0998230A1 - Faisceau de fibres optiques pour dispositif laser - Google Patents

Faisceau de fibres optiques pour dispositif laser

Info

Publication number
EP0998230A1
EP0998230A1 EP98934647A EP98934647A EP0998230A1 EP 0998230 A1 EP0998230 A1 EP 0998230A1 EP 98934647 A EP98934647 A EP 98934647A EP 98934647 A EP98934647 A EP 98934647A EP 0998230 A1 EP0998230 A1 EP 0998230A1
Authority
EP
European Patent Office
Prior art keywords
laser
optical
optic bundle
laser energy
fibers
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Withdrawn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
EP98934647A
Other languages
German (de)
English (en)
Inventor
Thomas J. Pacala
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.)
United States Surgical Corp
Original Assignee
United States Surgical 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 United States Surgical Corp filed Critical United States Surgical Corp
Publication of EP0998230A1 publication Critical patent/EP0998230A1/fr
Withdrawn legal-status Critical Current

Links

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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/02—Positioning or observing the workpiece, e.g. with respect to the point of impact; Aligning, aiming or focusing the laser beam
    • B23K26/06—Shaping the laser beam, e.g. by masks or multi-focusing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A61B2017/22074—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
    • A61B2017/22075—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel with motorized advancing or retracting means
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00392—Transmyocardial revascularisation
    • 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
    • A61B2018/2205—Characteristics of fibres
    • A61B2018/2211—Plurality of fibres

Definitions

  • the present disclosure relates to a laser fiber optic bundle for ablating body matter.
  • the laser fiber optic bundle is particularly suited for performing transmyocardial revascularization (T R) .
  • TMR transmyocardial revascularization
  • a CO2 laser was used to produce holes in the heart wall by transmitting laser energy from the laser to the heart wall.
  • Typical CO2 lasers used for transmyocardial revascularization (TMR) are externally located and have an articulated support arm for aiming and directing laser energy through a series of mirrors that reflect the energy onto the heart wall.
  • TMR transmyocardial revascularization
  • the entrance wound in the heart can be closed by relatively brief external pressure while the endocardial and myocardial layers remain open to permit blood flow from the ventricle to the heart muscle.
  • the intravascular method involves the direction of laser energy from inside the heart to form a bore in the heart wall while the other method involves introduction of the lasing apparatus through a relatively small incision in the patient's chest to access the outer wall of the heart.
  • the optical fiber conveying the laser energy and the laser generating source are typically manually advanced and controlled, respectively, to form a bore.
  • This manual advancement and control presents problems in that depth and rate of penetration are difficult to accurately reproduce for the multiple bores at the different areas of the heart which are necessary in myocardial revascularization procedures. For example, if the advancement rate of the laser is too slow and/or the laser generating source is left on for a long period of time, tissue damage from thermal and acoustic shock can result . As illustrated in the cross-sectional view of FIG.
  • a prior art fiber optic bundle designated generally at 100, includes a plurality of tightly packed fibers 112 enclosed in casing 110.
  • the individual fibers 112 in the laser fiber bundle 100 include an active area having a core 118 and an inactive area which includes the cladding 120 surrounding the core 118.
  • the cladding 120 is approximately 5 to 10% of the diameter of the core 118.
  • approximately 80% of the surface area of the fiber bundle is "active" during firing of the laser.
  • a 100 micron fiber can create a 300 micron hole.
  • the 300 micron hole created by the 100 micron fiber relates to a "zone of damage".
  • the fibers 112 are tightly packed, such as described above where 80% of the surface area is fibers and 20% is dead space, the laser light exiting the individual fibers 112 overlaps and increases the amount of the laser energy to which the tissue is exposed.
  • the fiber bundle 100 can be damaged and the fibers or tips need to be replaced.
  • a laser fiber optic bundle which includes a plurality of optical fibers each having an optical core.
  • the optical cores are separated from adjacent optical cores in a manner to reduce overlapping of the laser light being transmitted by the individual fibers.
  • the spaced apart configuration of the optic cores also lessens the likelihood that the tips of the fibers will be damaged.
  • the optical cores are separated by fillers, which can include various grades of powdered glass.
  • the optical cores are separated by hardened glue, which can include various types of epoxies.
  • the laser fiber optic bundle is suited for ablating tissue, particularly, heart tissue during a TMR procedure or plaque during laser angioplasty .
  • FIG. 1 is a cross-sectional view of a prior art laser fiber optic bundle
  • FIG. 2 is a cross-sectional view of a first embodiment of a laser fiber optic bundle in accordance with the present disclosure
  • FIG. 3 is a cross-sectional view of a second embodiment of a laser fiber optic bundle
  • FIG. 4 is a perspective view of a laser ablation device in association with the laser fiber optic bundle of FIG. 2;
  • FIG. 4A is a perspective view of a control module of the laser ablation device of FIG. 4;
  • FIG. 5 is a side view of the hand piece having a laser fiber optic bundle spaced from epicardium;
  • FIG. 6 is a side view showing piercing of the epicardium
  • FIG. 7 is a side view showing the laser fiber optic bundle being advanced through the myocardium and endocardium;
  • FIG. 8 is a side view showing withdrawal of the laser fiber optic bundle from the heart tissue to reveal the channel created therein.
  • FIG. 2 illustrates a first embodiment of a laser fiber designated generally at 200 having a laser fiber optic bundle 210.
  • the optic bundle 210 includes a plurality of laser fibers 212.
  • Each laser fiber 212 includes an optical core 216 surrounded by coating material 214.
  • Coating material 214 is preferably a glue, such as epoxy, but can also be any material suitable for encasing the optical cores.
  • the fiber bundle of Fig. 2 can be termed "loosely filled", since the optical cores 216 of laser 200 are spaced from each other due to the presence of coating material 214.
  • the optic bundle 210 is coated with an outside layer/sheath 218 which is preferably plastic. The result of using such a loosely packed laser fiber is more efficient use of energy and less collateral damage from over application of energy to the target material, such as tissue.
  • the diameter of each optical fiber 216 is approximately 100 to about 150 ⁇ m (core plus cladding typically 5-10% of core diameter, not shown) and the thickness of coating 214 is approximately 5-20 ⁇ m.
  • the diameter of fiber unit 212 is approximately 110- 170 ⁇ m.
  • the diameter of the optic bundle 210 typically contains from about 4 to about 100 fiber units 212. Therefore, the diameter of the optic bundle 210 is approximately 400 to about 20,000 ⁇ m.
  • optical core 216 is about 140 ⁇ m
  • coating 214 is about 30 ⁇ m
  • bundle 210 has 50 fiber units 212 and a diameter of 1400 ⁇ m.
  • a preferred ratio of active to non- active area, in cross section is from about 1:1 (50%) to about 1:4 (20%) and a preferred predetermined distance between adjacent optical core is about 50 to about 100 ⁇ m.
  • the method of manufacturing laser fiber 200 generally entails fabricating individual fibers from highly purified glass silica or plastic, as is known in the art.
  • Fibers 216 are then dipped or sprayed with coating material 214. A plurality of the individual coated fibers are encased within outside layer 218 to form optic bundle 210. The distal end of optic bundle 210 is then sliced to provide a flush cross-sectional distal end.
  • a second embodiment of a laser fiber designated generally at 300 having a laser fiber optic bundle 310.
  • optic bundle 310 includes a plurality of spaced laser fibers 312.
  • Each laser fiber includes an optical core 314.
  • the optical cores 31 are separated by a filler 318 which can include various types of glue, such as epoxy, and/or glass filler.
  • the diameter of each optical core 314 is approximately 100 to about 160 ⁇ m.
  • the optic bundle 310 can also include an outside layer 318, preferably a plastic sheath.
  • Laser fiber 300 can be manufactured by suspending fibers 312 in a desired spaced apart configuration and then by introducing a liquified epoxy and/or glass filler between the fibers. The epoxy and/or glass filler is left to solidify or otherwise take a set. Heat and/or pressure can be used to facilitate this process.
  • the optic bundle can then be coated with plastic layer 318.
  • the distal end of optic bundle 310 can then sliced to provide a flush cross- sectional distal end.
  • the individual optical cores are separated from adjacent optical cores in order to reduce the amount of overlapping energy transmitted through each optical core.
  • the zone of damage which is evident by the use of prior art lasers can be eliminated or substantially decreased.
  • the fibers in both embodiments are arranged in a manner such that approximately 40% of the surface area of the distal end of the laser is active during transmission of laser energy.
  • FIGS. 4 and 4A illustrate a laser ablation device shown generally at 10 in association with the laser fiber optic bundle of FIG. 2.
  • Device 10 preferably includes handle portion 12, an optical fiber advancing mechanism 14, a laser generator 16, a foot operated actuator 18, and a control module 20.
  • Control module 20 is shown with a receptacle 19 adapted to engage a terminal of a programmable computer to interface control module 20 with the computer.
  • a toggle switch 24 may be provided on the control module 20 to switch from an operation mode to a test mode.
  • An external selector 26 is provided so that the operator can select the desired maximum extension of the distal end of the optical fiber 200 from the handpiece 12.
  • the optical fiber advancing mechanism 12 is the type capable of precisely transmitting longitudinal motion to the optical fiber bundle 210.
  • the controlled longitudinal motion can be provided by one or more motors and preferably by one or more stepper motors.
  • the laser generator 16 may be either a continuous wave laser or a pulsed, high energy laser, such as, for example, an excimer, CO2 , Yag, or an alexandrite laser.
  • FIGS. 5-8 a method for producing a TMR channel utilizing the laser ablation device 10 in conjunction with the laser fiber optic bundle 210 is illustrated.
  • handpiece 12 is brought in proximity to the epicardium 52 of a heart patient.
  • the tip of optic fiber 200 protrudes slightly from optional locator ring 28 by distance D j _, where D-j_ is measured from the distal surface 200a of fiber 200 to the front surface 30 of locator ring 28.
  • Alternatively surface 200a can be flush with front surface
  • the fiber tip surface 200a is disposed substantially adjacent epicardium 52. If initially protruding a distance Dj_, the fiber tip initially advances through at least a portion of the epicardium 52 and myocardium 50 with less laser energy being applied to tissue as compared to the laser energy applied further into the heart. This is due to the "tented" tissue initially moving towards the handpiece upon commencement of laser firing.
  • This less ablated tissue, 54 will substantially return to its natural position following channel formation and act as a cap to reduce bleeding from the channel.
  • the TMR channel is formed by transmitting laser energy from the tip of fiber 200 to ablate heart tissue while correspondingly advancing optical fiber 200.
  • the fiber tip is advanced through the myocardium 50 and endocardium 56 until it reaches its maximum extended position corresponding to the distance D2 between fiber tip surface 200a and the surface 30 of locator ring 28.
  • fiber 200 is preferably advanced at a rate that is coordinated with the power level and the frequency of pulsing of the laser generator.
  • optical fiber 200 can be advanced at a rate of between about 0.125mm/sec (0.005 in/sec) to about 12.7mm/sec (0.5 in/sec) with a laser power level of about 10 mJ/mm 2 to about 60 mJ/mm 2 and a pulsing frequency of about 5 Hz to about 400 Hz.
  • the optical fiber 200 is advanced at a rate of about 0.75mm/sec to about 2.
  • the rate of advancement of the optical fiber 200 is no greater than the rate of ablation of tissue in order to minimize mechanical tearing by the fiber 200.
  • the advancing mechanism can be set to advance the fiber 200 at a rate greater than the ablation rate.
  • a xenon chloride excimer laser operating at a power level of about 35mJ/mm 2 can ablate about 30-35 microns of animal heart tissue per pulse.
  • the epicardium/myocardial tissue 54 that was pushed aside with less ablation during penetration of fiber 200 returns to its original location coinciding with channel 60 upon the fiber's withdrawal.
  • This tissue 54 forms a flap that acts as the cap for the channel 60 to reduce bleeding from the channel 60 at the epicardium 52.
  • the interface 62 between the flap of tissue 54 and the adjacent tissue is generally an annular ring less than 360_ in extent.
  • the flap 54 can consist of both epicardial and myocardial tissue, but could alternatively be just epicardial tissue.
  • fiber 200 can be moved to another location on the epicardium 52 to begin forming another channel, without the necessity of applying extended pressure to the portion of the epicardium coinciding with just-formed channel 60.
  • the overall procedure wherein dozens of channels 60 are typically formed can thus be performed much faster as compared to other methods .
  • alternate devices can be used to actuate the laser advancing device and the laser energy source, such as a trigger mechanism associated with the handle portion.
  • the laser fiber optic bundle 210 and fiber advancing mechanism 14 can also be used to perform other medical procedures, besides TMR, such as laser angioplasty and laser keratotomy. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended thereto.

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  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Electromagnetism (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Plasma & Fusion (AREA)
  • Mechanical Engineering (AREA)
  • Laser Surgery Devices (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

Cette invention se rapporte à un faisceau de fibres optiques (210)(310) pour dispositif laser, constitué d'une pluralité de fibres optiques (212)(312) comportant chacune une âme optique (216)(314). Ces âmes optiques(216)(314) sont espacées les unes des autres de façon à réduire le chevauchement des rayons laser émis par les fibres individuelles (216)(312). Cet espacement des âmes optiques (216)(314) peut également réduire les dégâts susceptibles d'être occasionnés aux pointes des fibres (212)(312) en raison de l'intensité de l'énergie laser émise. Dans une première réalisation, les âmes optiques (216) sont enduites d'une colle (214) pouvant être choisie parmi diverses résines époxy. Dans une seconde réalisation, les âmes optiques (314) sont enrobées par une charge (318) qui peut être composée de verre en poudre de diverses qualité et/ou d'une matière collante. Ledit faisceau de fibres (210)(310) pour dispositif laser est particulièrement adapté aux applications d'ablation de tissus, notamment de tissu cardiaque, et peut donc être mis en oeuvre au cours de procédures de revascularisation transmyocardique.
EP98934647A 1997-07-22 1998-07-20 Faisceau de fibres optiques pour dispositif laser Withdrawn EP0998230A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US5336397P 1997-07-22 1997-07-22
US53363P 1997-07-22
PCT/US1998/014928 WO1999004707A1 (fr) 1997-07-22 1998-07-20 Faisceau de fibres optiques pour dispositif laser

Publications (1)

Publication Number Publication Date
EP0998230A1 true EP0998230A1 (fr) 2000-05-10

Family

ID=21983707

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98934647A Withdrawn EP0998230A1 (fr) 1997-07-22 1998-07-20 Faisceau de fibres optiques pour dispositif laser

Country Status (4)

Country Link
EP (1) EP0998230A1 (fr)
AU (1) AU8412998A (fr)
CA (1) CA2298007A1 (fr)
WO (1) WO1999004707A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2001250334A1 (en) * 2000-02-23 2001-09-03 Carl Zeiss Meditec Ag Handpiece for radiating light onto a skin surface during a medical or cosmetic skin treatment
US6464693B1 (en) 2000-03-06 2002-10-15 Plc Medical Systems, Inc. Myocardial revascularization
US20110297735A1 (en) * 2010-06-02 2011-12-08 Medinol, Ltd. Method and apparatus for stent manufacturing assembly

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK138437B (da) * 1976-11-09 1978-09-04 Nordiske Kabel Traad Lysledende element til brug ved indbygning i optiske transmissionsorganer.
JPH04126125A (ja) * 1990-09-18 1992-04-27 Toshiba Corp 内視鏡
US5148509A (en) * 1991-03-25 1992-09-15 Corning Incorporated Composite buffer optical fiber cables
US5703985A (en) * 1996-04-29 1997-12-30 Eclipse Surgical Technologies, Inc. Optical fiber device and method for laser surgery procedures

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9904707A1 *

Also Published As

Publication number Publication date
WO1999004707A1 (fr) 1999-02-04
CA2298007A1 (fr) 1999-02-04
AU8412998A (en) 1999-02-16

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