WO2011027282A1 - Dispositif de distribution de lumière à fibres optiques pourvu d'une fibre plastique dans sa partie distale - Google Patents

Dispositif de distribution de lumière à fibres optiques pourvu d'une fibre plastique dans sa partie distale Download PDF

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Publication number
WO2011027282A1
WO2011027282A1 PCT/IB2010/053880 IB2010053880W WO2011027282A1 WO 2011027282 A1 WO2011027282 A1 WO 2011027282A1 IB 2010053880 W IB2010053880 W IB 2010053880W WO 2011027282 A1 WO2011027282 A1 WO 2011027282A1
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WIPO (PCT)
Prior art keywords
fibre
distal part
plastic
fiber
light
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Ceased
Application number
PCT/IB2010/053880
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English (en)
Inventor
Roland Bays
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.)
Medlight SA
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Medlight SA
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Filing date
Publication date
Application filed by Medlight SA filed Critical Medlight SA
Publication of WO2011027282A1 publication Critical patent/WO2011027282A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • G02B6/0001—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems
    • G02B6/0005—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems the light guides being of the fibre type
    • G02B6/0008—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings specially adapted for lighting devices or systems the light guides being of the fibre type the light being emitted at the end of the fibre
    • 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
    • A61N5/0601—Apparatus for use inside the body
    • 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
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent
    • 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
    • G02B6/241—Light guide terminations
    • 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
    • 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
    • A61B2018/2222—Fibre material or composition
    • 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
    • A61B2018/2255—Optical elements at the distal end of probe tips
    • A61B2018/2261—Optical elements at the distal end of probe tips with scattering, diffusion or dispersion of light

Definitions

  • the present invention relates to apparatuses for transmitting and diffusing light for delivery to a target site to be illuminated, heated, irradiated, or treated by exposure to light.
  • the present invention relates to the delivery of light to a body lumen or body cavity for photodynamic therapy of atherosclerosis, 10 malignant or benign tumor tissue, cancerous cells and other medical treatments.
  • Photodynamic Therapy is a known method of treating target regions or 5 sites, such as tumors, atheromatous plaques and other tissues, in humans by administering a photosensitizing substance to a patient and allowing it to concentrate preferentially in the target sites. It has been found that certain abnormal growths, such as certain cancerous tissue and atheromatous plaque, have an affinity for these photosensitizing agents.
  • Photosensitizing agents are 0 compounds that, when exposed to light, or light of a particular wavelength or wavelengths, create 0 2 radicals which react with the target cells. Examples of such agents include texaphyrins, hematoporphyrin, chlorins, and purpurins.
  • an appropriate photosensitizing agent is used to create the 0 2 radicals which kill the target cells.
  • an appropriate photosensitizing agent is activated to destroy the plaque by lysis (breaking up) of such plaque.
  • Mechanisms other than lysis, e.g. cell apoptosis, may also be involved.
  • 0 Photoactivation of the photosensitizer is achieved by locally delivering light to the target region, preferably in a manner which achieves an optimum "dose" and emission configuration which is consistent with the volume and geometry of the target tissue. This may be accomplished through the use of light delivery systems which utilize optical fibers.
  • an optical fiber may be equipped with an apparatus at its tip which disperses light propagating along the fiber in a uniform cylindrical pattern with respect to the central axis of the optical fiber. Uniformity is usually desired to ensure delivering a known and optimum dose.
  • a number of diffuser tip designs have been developed to produce a controlled and generally uniform profile of illumination.
  • One approach ('radial coupling') which is illustrated in Fig.
  • a distal segment of the waveguide typically an optical fiber. Such modifications include etching the fiber cladding or creating fiber gratings within the fiber core.
  • Another approach ('frontal coupling') which is illustrated in Fig. 1 b, involves launching light from the distal end of a waveguide into a diffuser tip containing scattering medium, wherein the light is launched in a primarily axial direction and is distributed radially outward by the optical scattering medium. Both approaches can be based either on glass optical fiber or plastic optical fiber. When a high flexibility of the catheter is necessary, the first approach, the 'radial coupling', using the plastic optical fiber, is an appropriated practical option.
  • plastic makes possible etching the fiber cladding or other material modifications inducing change of the transmission of the fiber at the diffusing tip, without risk of fragility of the modified part.
  • plastic optical fiber shows much better flexibility property than glass fiber.
  • the product a cylindrical light diffuser, model RD, is used for standard PDT treatment protocol of the cholangiocarcinoma where a high bending of the catheter is required at the entrance of the biliary duct (see Fig. 2) and also all along the hepatic ducts in order to guide the diffusing tip in the specific intrahepatic branches to be treated.
  • the other cylindrical light diffuser presently on the market are based on glass optical fiber and 'frontal coupling' approach. There are stiff and show high probability of breakage especially at the interface between the glass optical fiber and the diffusing scattering tip as it is shown by Todd H. Baron in Editorial of Clinical Gastroenterology and Hepatology, 2008, 6, 266-267. Such a breakage occurs during the introduction of the catheter in the patient and can induce, during the treatment, a serious change of the light intensity and distribution along the diffusing tip. Such a breakage and change are usually not detectable by simple visual inspection by the physician during or after the treatment. Consequently their medical outcomes are difficult to avoid. Moreover, because of their stiffness, treatment is generally limited to the main hepatic ducts since the fiber does not bend around corners to reach intrahepatic branches.
  • Plastic fibers may therefore appear to be the best candidates. Unfortunately they show a high variation in light transmission property, this parameter is a function of the wavelength (see Fig. 3). For light delivery between 630 nm and 710 nm, corresponding to the excitation wavelengths of PDT photosensitizing agents presently commercialized, the transmission is acceptable (typ. > 70%) for appropriated catheter length (2-3 meters long). However, for new photosensitizing agents, with the excitation wavelengths between 710 and 800 nm, the design based on the plastic optical fiber does not appear applicable, the transmission of the plastic fiber being too low at these wavelengths.
  • cylindrical light diffuser with an acceptable light transmission property (typ. > 70%) at all of the wavelengths of interest and which can be used in organs where high bending capability is required during the positioning of the diffuser tip and this without risk of breakage.
  • the present invention aims, in particular, to alleviate the aforementioned problems.
  • a medical cylindrical light delivery device for the irradiation of biological tissues within the context of photodynamic treatment, this device comprising a proximal part made of a glass fiber and a distal part made of a plastic fiber, said distal part comprising a diffusing tip which is adapted to provide a radial emission of the light and both fibers being connected by frontal coupling.
  • FIG. 1a illustrates the radial coupling approach as known from the prior art.
  • FIG. 1 b illustrates the frontal coupling approach as known from the prior art.
  • FIG. 2 is a radioscopic view of a biliary duct showing a cylindrical light diffuser according to the prior art.
  • the angle ⁇ is perennial to 50 degrees.
  • FIG. 3 shows the transmission of a plastic optical fiber according to the prior art as a function of the wavelength for different fiber lengths.
  • FIG.4 illustrates a light delivery device according to the present invention.
  • List of numerical reference used in the figures :
  • Waveguide optical fiber
  • the present invention combines the 2 design approaches, radial and frontal coupling, and the 2 optical fiber technologies, glass and plastic fiber.
  • the first part of the device is based on a glass optical fiber, with its good transmission properties but low flexibility. It transmits the light from the light source to the proximity of the treatment site.
  • the light is launched in a plastic optical fiber section whose the extremity, the diffusing tip, is modified, including etching the fiber cladding or creating fiber gratings within the fiber core, in order to obtain controlled radial emission along the diffusing tip.
  • the length of the plastic fiber section, corresponding to the high flexible part of the device is selected as short as possible (typ.
  • the cylindrical light diffuser shows suitable flexibility property where is required and the interface between the glass and the plastic fiber is never submitted to mechanical strain.
  • the length of the flexible section can be optimized as a function of the application (treatment site geometry and protocol).
  • the length of the proximal part of the device according to the invention is comprised between 25 cm and 4 meters.
  • the length of the distal part of the device according to the invention is comprised between 2 cm and 2 meters.
  • the length of the distal part is preferably comprised between 25 cm and 50 cm.
  • the length ratio between said proximal part and said distal part is comprised between 0.125 and 200.
  • Example of design Cylindrical light diffuser for illumination of the hepatic ducts.
  • the extremity of a standard gastroscope is positioned at the entrance of the biliary duct (see Fig. 2).
  • a standard ERCP catheter catheter of opacification
  • the cylindrical light diffuser is positioned in the ERCP catheter with the diffusing tip in front of the lesion to be treated.
  • the illumination is performed through the wall of the ERCP catheter.
  • a 25-50 cm length for the flexible section based on plastic fiber is suitable.
  • the transmission of the device is higher than 70% for the wavelength range of interest in PDT, 630-800 nm, and the flexible part is long enough to cover all of the section of the ERCP catheter where stiffness and fragility are critical (from the entrance of the biliary duct).
  • the interface between the glass and plastic optical fiber is, all over the treatment, protected in the working channel of the scope, with low bending risk.
  • the length of the flexible part based on plastic fiber could be longer or shorter. In some applications, it could be as short as the diffusing tip.

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Radiation-Therapy Devices (AREA)
  • Laser Surgery Devices (AREA)

Abstract

L'invention concerne un dispositif cylindrique, à usage médical, de distribution de lumière destiné à irradier des tissus biologiques dans le contexte d'un traitement photodynamique, ce dispositif comprenant une partie proximale constituée d'une fibre de verre (10) et une partie distale constituée d'une fibre plastique (12), la partie distale comprenant un embout de diffusion (13), qui est adapté pour générer une émission radiale de lumière, et à la fois des fibres raccordées par accouplement frontal (11).
PCT/IB2010/053880 2009-09-04 2010-08-30 Dispositif de distribution de lumière à fibres optiques pourvu d'une fibre plastique dans sa partie distale Ceased WO2011027282A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IB2009053876 2009-09-04
IBPCT/IB2009/053876 2009-09-04

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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015142623A1 (fr) * 2014-03-18 2015-09-24 Boston Scientific Scimed, Inc. Fils-guides de détection de pression
US9429713B2 (en) 2014-04-17 2016-08-30 Boston Scientific Scimed, Inc. Self-cleaning optical connector
US9775523B2 (en) 2013-10-14 2017-10-03 Boston Scientific Scimed, Inc. Pressure sensing guidewire and methods for calculating fractional flow reserve
US9782129B2 (en) 2014-08-01 2017-10-10 Boston Scientific Scimed, Inc. Pressure sensing guidewires
US9795307B2 (en) 2014-12-05 2017-10-24 Boston Scientific Scimed, Inc. Pressure sensing guidewires
US10028666B2 (en) 2013-03-15 2018-07-24 Boston Scientific Scimed, Inc. Pressure sensing guidewire
US10278594B2 (en) 2014-06-04 2019-05-07 Boston Scientific Scimed, Inc. Pressure sensing guidewire systems with reduced pressure offsets
US10499820B2 (en) 2013-05-22 2019-12-10 Boston Scientific Scimed, Inc. Pressure sensing guidewire systems including an optical connector cable
US10582860B2 (en) 2012-08-27 2020-03-10 Boston Scientific Scimed, Inc. Pressure-sensing medical devices and medical device systems
US10702162B2 (en) 2010-11-09 2020-07-07 Opsens Inc. Guidewire with internal pressure sensor
US10835182B2 (en) 2013-08-14 2020-11-17 Boston Scientific Scimed, Inc. Medical device systems including an optical fiber with a tapered core
US11058307B2 (en) 2016-02-23 2021-07-13 Boston Scientific Scimed, Inc. Pressure sensing guidewire systems including an optical connector cable
US11076765B2 (en) 2013-07-26 2021-08-03 Boston Scientific Scimed, Inc. FFR sensor head design that minimizes stress induced pressure offsets
US11311196B2 (en) 2018-02-23 2022-04-26 Boston Scientific Scimed, Inc. Methods for assessing a vessel with sequential physiological measurements
US11559213B2 (en) 2018-04-06 2023-01-24 Boston Scientific Scimed, Inc. Medical device with pressure sensor
US11564581B2 (en) 2017-08-03 2023-01-31 Boston Scientific Scimed, Inc. Methods for assessing fractional flow reserve
US11666232B2 (en) 2018-04-18 2023-06-06 Boston Scientific Scimed, Inc. Methods for assessing a vessel with sequential physiological measurements
US11850073B2 (en) 2018-03-23 2023-12-26 Boston Scientific Scimed, Inc. Medical device with pressure sensor
US12087000B2 (en) 2021-03-05 2024-09-10 Boston Scientific Scimed, Inc. Systems and methods for vascular image co-registration

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WO1993018715A1 (fr) * 1992-03-20 1993-09-30 The General Hospital Corporation Source lumineuse laser
EP0935485A1 (fr) 1997-09-04 1999-08-18 Medlight S.A. Dispositif diffuseur de lumiere pour le traitement photodynamique d'organes
WO2007127894A2 (fr) * 2006-04-28 2007-11-08 Ondine International Ltd. dispositifs et procédés d'administration de photodésinfection
EP1949877A1 (fr) * 2007-01-23 2008-07-30 Alcon, Inc. Sonde à illuminateur robuste thermiquement
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Publication number Priority date Publication date Assignee Title
WO1993018715A1 (fr) * 1992-03-20 1993-09-30 The General Hospital Corporation Source lumineuse laser
EP0935485A1 (fr) 1997-09-04 1999-08-18 Medlight S.A. Dispositif diffuseur de lumiere pour le traitement photodynamique d'organes
EP0935485B1 (fr) * 1997-09-04 2005-08-17 Medlight S.A. Dispositif diffuseur de lumiere pour le traitement photodynamique d'organes
WO2007127894A2 (fr) * 2006-04-28 2007-11-08 Ondine International Ltd. dispositifs et procédés d'administration de photodésinfection
EP1949877A1 (fr) * 2007-01-23 2008-07-30 Alcon, Inc. Sonde à illuminateur robuste thermiquement
US20080269845A1 (en) * 2007-04-27 2008-10-30 Ondine International, Ltd. Waveguide connection device

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Title
HUDSON E J ET AL: "The development of radio-opaque, isotropic, fibre-optic probes for light dosimetry studies in photodynamic therapy", PHYSICS IN MEDICINE AND BIOLOGY, TAYLOR AND FRANCIS LTD. LONDON, GB, vol. 38, no. 10, 1 October 1993 (1993-10-01), pages 1529 - 1536, XP002285621, ISSN: 0031-9155, DOI: DOI:10.1088/0031-9155/38/10/013 *
TODD H. BARON ET AL: "Photodynamic Therapy: Standard of Care for Palliation of Cholangiocarcinoma?", CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, AMERICAN GASTROENTEROLOGICAL ASSOCIATION, US, vol. 6, no. 3, 5 March 2008 (2008-03-05), pages 266 - 267, XP022549201, ISSN: 1542-3565 *
TODD H. BARON, EDITORIAL OF CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, vol. 6, 2008, pages 266 - 267

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11786130B2 (en) 2010-11-09 2023-10-17 Opsens Inc. Guidewire with internal pressure sensor
US10750949B2 (en) 2010-11-09 2020-08-25 Opsens Inc. Guidewire with internal pressure sensor
US10702162B2 (en) 2010-11-09 2020-07-07 Opsens Inc. Guidewire with internal pressure sensor
US10582860B2 (en) 2012-08-27 2020-03-10 Boston Scientific Scimed, Inc. Pressure-sensing medical devices and medical device systems
US10028666B2 (en) 2013-03-15 2018-07-24 Boston Scientific Scimed, Inc. Pressure sensing guidewire
US10499820B2 (en) 2013-05-22 2019-12-10 Boston Scientific Scimed, Inc. Pressure sensing guidewire systems including an optical connector cable
US11076765B2 (en) 2013-07-26 2021-08-03 Boston Scientific Scimed, Inc. FFR sensor head design that minimizes stress induced pressure offsets
US10835182B2 (en) 2013-08-14 2020-11-17 Boston Scientific Scimed, Inc. Medical device systems including an optical fiber with a tapered core
US10499817B2 (en) 2013-10-14 2019-12-10 Boston Scientific Scimed, Inc. Pressure sensing guidewire and methods for calculating fractional flow reserve
US9775523B2 (en) 2013-10-14 2017-10-03 Boston Scientific Scimed, Inc. Pressure sensing guidewire and methods for calculating fractional flow reserve
WO2015142623A1 (fr) * 2014-03-18 2015-09-24 Boston Scientific Scimed, Inc. Fils-guides de détection de pression
US10932679B2 (en) 2014-03-18 2021-03-02 Boston Scientific Scimed, Inc. Pressure sensing guidewires and methods of use
US9429713B2 (en) 2014-04-17 2016-08-30 Boston Scientific Scimed, Inc. Self-cleaning optical connector
US9563023B2 (en) 2014-04-17 2017-02-07 Boston Scientific Scimed, Inc. Self-cleaning optical connector
US10278594B2 (en) 2014-06-04 2019-05-07 Boston Scientific Scimed, Inc. Pressure sensing guidewire systems with reduced pressure offsets
US9782129B2 (en) 2014-08-01 2017-10-10 Boston Scientific Scimed, Inc. Pressure sensing guidewires
US9795307B2 (en) 2014-12-05 2017-10-24 Boston Scientific Scimed, Inc. Pressure sensing guidewires
US11058307B2 (en) 2016-02-23 2021-07-13 Boston Scientific Scimed, Inc. Pressure sensing guidewire systems including an optical connector cable
US11564581B2 (en) 2017-08-03 2023-01-31 Boston Scientific Scimed, Inc. Methods for assessing fractional flow reserve
US11311196B2 (en) 2018-02-23 2022-04-26 Boston Scientific Scimed, Inc. Methods for assessing a vessel with sequential physiological measurements
US12369800B2 (en) 2018-02-23 2025-07-29 Boston Scientific Scimed, Inc. Methods for assessing a vessel with sequential physiological measurements
US11850073B2 (en) 2018-03-23 2023-12-26 Boston Scientific Scimed, Inc. Medical device with pressure sensor
US11559213B2 (en) 2018-04-06 2023-01-24 Boston Scientific Scimed, Inc. Medical device with pressure sensor
US11666232B2 (en) 2018-04-18 2023-06-06 Boston Scientific Scimed, Inc. Methods for assessing a vessel with sequential physiological measurements
US12268482B2 (en) 2018-04-18 2025-04-08 Boston Scientific Scimed, Inc. Methods for assessing a vessel with sequential physiological measurements
US12087000B2 (en) 2021-03-05 2024-09-10 Boston Scientific Scimed, Inc. Systems and methods for vascular image co-registration

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