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WO1998034681A1 - Appareil et procede permettant une radiotherapie intravasculaire - Google Patents

Appareil et procede permettant une radiotherapie intravasculaire Download PDF

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Publication number
WO1998034681A1
WO1998034681A1 PCT/US1998/002790 US9802790W WO9834681A1 WO 1998034681 A1 WO1998034681 A1 WO 1998034681A1 US 9802790 W US9802790 W US 9802790W WO 9834681 A1 WO9834681 A1 WO 9834681A1
Authority
WO
WIPO (PCT)
Prior art keywords
wire
radioactive source
distal end
source
alloy
Prior art date
Application number
PCT/US1998/002790
Other languages
English (en)
Inventor
Anthony J. Bradshaw
Steven L. Weinberg
Albert E. Raizner
John P. Edison
Original Assignee
Guidant Corporation
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 Guidant Corporation filed Critical Guidant Corporation
Priority to AU63250/98A priority Critical patent/AU6325098A/en
Publication of WO1998034681A1 publication Critical patent/WO1998034681A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002—Intraluminal radiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N2005/1019—Sources therefor
    • A61N2005/1025—Wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007—Arrangements or means for the introduction of sources into the body

Definitions

  • the present invention relates generally to radioactive sources used for treatment
  • the invention resides in a device, apparatus, and methods for treating tissue by irradiation with a predetermined dose from a radioactive source
  • the invention are especially well suited for brachytherapy in which a malignant tumor is exposed
  • Brachytherapy a technique for radiation treatment of malignant tumors, attacks the tumor from within the body.
  • the method typically utilizes a radioactive source wire in
  • a radioisotope sealed at and substantially integral with the distal tip of a relatively thin wire or cable is delivered via a pathway formed by a catheter or through a natural cavity, duct or vessel of the body directly to the tumor site for localized irradiation.
  • the radioactive source with an activity level in a range up to
  • an afterloader which has
  • a drive system to which the proximal end of the source wire is connected.
  • the treatment is fractionated, in that repeated short intervals of
  • the afterloader may be provided with a turret for automatic delivery of the source
  • the desired treatment time in each case is programmed into the afterloader's control unit.
  • the treatment regimen may be repeated at regular intervals over a period of
  • This type of radiation therapy has the advantage of
  • This type of therapy is particularly suitable for treating inoperable malignancies located deep within the body, with consequent difficulty of access to the tumor site, so that
  • the source wire is guided along a path to the site provided by an implanted catheter.
  • catheter may be positioned in place using a previously implanted guidewire or "rail" over which
  • the source wire can be advanced and retracted along a lumen of
  • radioactive source or core such as substantially pure iridium which has
  • isotope Ir- 192 having suitable relatively high activity level (e.g., ten or more curies) for tumor treatment.
  • the radioactive source such as in or through the biliary tract or the bronchi of the lungs. Also, the radioactive source
  • a solid source wire is capable of accommodating the Ir-192 or other source
  • a solid wire can be produced by specialized techniques to have a diameter as
  • the source wire may be composed of stainless
  • source material may be installed in the wire and the entire source wire then subjected to
  • the source material alone is subjected to the neutron flux and subsequently assembled in the wire by means of shielded, remotely controlled handling and manipulating techniques.
  • Restenosis is a recurrence of the stricture or narrowing of the vascular lumen following
  • radioactive source wire and apparatus and methods of use thereof, which are equally suited
  • the source wire of the invention is
  • nitinol composed of a nickel-titanium alloy, known commercially as nitinol, which has desirable
  • Radioactive source material such as Ir-192 (iridium
  • isotope spheres
  • nitinol source wire is readily returned by the drive system of the afterloader to safe storage
  • the wire is composed of a shape memory alloy, the nickel/titanium alloy known
  • nitinol being preferred.
  • Such material possesses super-elastic properties and the capability, at proper temperature, of transforming from an unstressed austenitic state (being a straight configuration) to a stress induced martensitic state, and the capability of returning to the austenitic state when the externally induced stress is removed.
  • Nitinol has been used commercially in bendable frames for lenses (eyeglasses). It has also been used in the past for guidewires (rails) that are employed in various parts of the
  • the guidewire dispenses with the need to
  • the procedure for which the nitinol source wire is used may be a brachytherapy
  • the brachytherapy (oncology) afterloader is more complex because of the large number of targets (i.e., plural tumor treatment sites which may be anywhere in the body, versus
  • the coronary afterloader need not have a turret, or at most, a two-position
  • each machine may be entirely conventional.
  • afterloader equipment is adapted to advance a simulation wire (non-radioactive) through the simulation wire (non-radioactive) through the simulation wire (non-radioactive)
  • the simulation wire has an opaque
  • tip marker to facilitate the fluoroscopic observation, and the precise location of the target area
  • the treatment is performed automatically by remote operation of the afterloader which is located in a radiation-shielded room where the patient is placed for the
  • a treatment catheter is coupled to the end of the afterloader connector and
  • radioactive source on the source wire In the case of coronary radiotherapy, the source
  • a non-centered source would deliver too small a dose of radiation to one side of
  • FIG. 1 is a simplified view of a typical arrangement for implementing a
  • FIG. 2 is a fragmentary, perspective view of a catheter, guidewire, and source
  • FIG. 3 is a simplified side view of the system of FIG. 2;
  • FIG. 3 A is a sectional view through the lines A-A of FIG. 3;
  • FIG. 4 is a fragmentary sectional side view of the source wire showing an exemplary assembly of the radioactive source material and special wire material according to
  • FIG. 5 A is a plan view of a centering balloon according to the present invention.
  • FIG. 5B is a perspective view of the centering balloon of FIG. 5 A of a section taken through a plane containing the line 5-5.
  • the invention in one of its aspects is used in treatment
  • a brachytherapy system or a coronary radiotherapy system.
  • the patient 10 is moved into a radiation-shielded treatment room where the procedure will be
  • a treatment catheter 12 is implanted in the patient, and, in the coronary or cardiac
  • the entire afterloader may be completely conventional for the
  • aspects of the present invention are applicable to both types of treatment.
  • the patient 10 is placed in a supine or a prone position on a table
  • the afterloader is controlled by the attending physician, an oncologist in the case of
  • brachytherapy treatment or a cardiologist in the case of cardiac treatment, and/or by a
  • control console 22 may be in the
  • console and attendant may be located outside the shielded treatment room.
  • a fluoroscope 28 is positioned above the patient, although its use would usually be required only for the cardiac treatment.
  • a video camera and display monitor 30 are posi ⁇
  • the method used in performing brachytherapy is entirely conventional, and
  • the source wire is an assembly including an elongate wire composed of a nickel/titanium alloy commercially
  • Nitinol itself is available, for example, from Shape Memory Alloys of Sunnyvale, California. The material is described, for example, in U.S. Patent No. 4,665,906.
  • the nickel-titanium alloy which gives the wire its super-elastic properties is stored in its austenitic state, characterized
  • the nitinol in the source wire of the invention, the nitinol
  • the transition temperature which is typically 15° C ⁇ 5° C, for example, and is normally in the austenitic state except when the wire
  • the nitinol wire reassumes its straightness in the austenitic
  • the nitinol wire is heat treated while
  • nitinol can be drawn and successively redrawn to progressively smaller diameters.
  • source wire according to the invention. It was necessary to produce the wire in its final form (i.e., with predetermined dimensional characteristics including desired diameter and length) and
  • an axial hole may be formed at the distal end of the wire to house the source material
  • a second process also performed by Raychem Corporation, produced a similar form of wire but which constituted a thin-walled nitinol tube clad over a nitinol backbone wire
  • portion is selected to provide the hole of desired depth to house the source material.
  • Other dimensions of the tube/backbone wire are substantially the same as those described above for
  • a third process which was used only to produce the axial hole in the tip of a nitinol wire of the final desired diameter, involved the use of electrical discharge machining
  • FIG. 4 The nitinol elongate wire 38 with axial hole 39 in its distal tip is loaded with
  • radioactive source material such as iridium isotope Ir-192 spheres 40 of slightly smaller
  • the radioactivity level of the total source material in the wire is preferably about one to two curies for the cardiac application, and from that activity up to
  • a nitinol plug 42 of preferably rounded shape After loading the source material, a nitinol plug 42 of preferably rounded shape
  • the source material may be enriched Ir-192, and in any event is
  • the wire up to the point at which the taper begins is useful to provide the column strength sufficient for drivability of the wire by the afterloader.
  • the afterloader For example, in the embodiment of FIG.
  • the distal end 45 of the wire may be tapered over the last six inches to the tip, by drawing that
  • the cable can similarly be tapered. This is accomplished by tapering every strand at the distal end,
  • the multi-strand cable form may be assembled with a small capsule containing the radioactive source material, by welding
  • Each strand may have an extremely small cross-
  • cables have been produced without taper in stainless steel, but a form used in accordance with the present invention would employ nitinol strands.
  • a treatment catheter 12 (FIGS. 1, 3) is implanted
  • the catheter is also coupled to the afterloader
  • the catheter for that application may be provided with small channels to allow sufficient blood flow (perfusion)
  • the afterloader connector 50 is also coupled to the
  • the guidewire 52 would begin uncontrollable spinning because of the eccentricity of its lumen 58 in the catheter. Orientation of the guidewire channel is also extremely important,
  • the cardiac application of the radioactive source wire is extremely size sensitive.
  • a suitable level of radioactivity for the source in the cardiac application is one
  • Radioactivity delivered to the wall surface depends on factors such as the length of source, the length of the lesion and the curie level on the day the treatment is performed, and the length of
  • the balloon is deflated to allow the heart (or the portion being treated) to
  • one side of the interior surface of the artery may be 2V ⁇ mm from the
  • the vessel wall about 1,000 rads, will result in no discernible prevention of restenosis.
  • an inflatable balloon 60 (FIG. 5 A) is provided in the catheter for centering the source tip of the source wire.
  • tissue at a given distance of the vessel wall from the source (actually, from the distal tip of the
  • the treatment catheter requires a specified activity level for the source, which drops off according to the inverse square of the distance, and an appropriate period of treatment.
  • segmentation may include, in addition to the working treatment (i.e., radiotherapy source wire) channel or lumen 54, a guidewire lumen 58, and a lumen 56 for inflating the centering balloon.
  • fluted balloons, or otherwise channeled balloons may be used, alone or together with a
  • the treatment method for a coronary artery is performed substantially
  • the method includes implanting a catheter in the patient to provide a pathway from a point external
  • a source wire including an elongate lead having a distal
  • the elongate lead is selected to be sufficiently flexible and mechanically strong to
  • the distal tip of the source wire is centered in the lumen of the coronary artery to produce substantially uniform irradiation of
  • the radioactive tissue in a circumferential region of the arterial tissue adjacent the source as the targeted tissue is irradiated for a predetermined interval of time sufficient to deliver a prescribed dose of radiation.
  • the source wire is withdrawn from the catheter immediately when the time
  • a type of centering mechanism other than a balloon may be used, although the
  • centering balloon is preferred, but should also be of a type and shape that will permit sufficient
  • a disadvantage of using a different mechanism from a balloon is that the means for
  • Balloon inflation and deflation in a catheter is in and of itself a conventional procedure with a proven record of safety.
  • the irradiation procedure is preferably performed very soon after the balloon
  • the guidewire is left in place during the period of treatment because it allows a
  • the guidewire is steered into the part of the heart being targeted, using a fluoroscope, so that it becomes the first component in and the last out.
  • the catheter is placed over the guidewire, and in available size ranges, is capable
  • the artery dictates the choice of treatment catheter as well as the radioactivity dose. If it is determined that the dose should be 1,450 rads, for example, that value is entered on the control console of the afterloader, or other factors may be entered by which a microprocessor in the
  • control console may calculate the dose according to location of the target, size of lumen, center of the lumen (distance to the interior wall surface), curie rating per day, and other known
  • a fail-safe function of the afterloader senses patient problems when the coronary radiotherapy is administered. In the event that the patient is experiencing pain or other
  • the control console of the afterloader enables programming of the desired functions. For example, a one to one and one-half minute interval may be timed
  • the afterloader retains all necessary data such as the dose delivered during

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  • 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)
  • Radiation-Therapy Devices (AREA)

Abstract

On utilise un fil métallique (38) source doté d'une source (40) radioactive au niveau de sa pointe (45) distale, pour traiter un vaisseau sanguin dans le corps d'un patient par radiation in vivo localisée et empêcher la sténose du vaisseau sanguin, y compris la resténose consécutive à une angioplastie coronaire transluminale percutanée. On fait progresser ledit fil (38) source vers la zone cible le long du système vasculaire du corps du patient et ce, à partir d'un point extérieur au corps. Le fil métallique (38) est, de préférence, un filament solide dont l'épaisseur est sensiblement uniforme sur toute sa longueur. Il est réalisé dans un alliage nickel-titane (nitinol) très élastique. Dans un autre mode de réalisation, le fil métallique (38) peut être un câble composé de multiples brins en alliage, l'épaisseur de chaque brin étant sensiblement uniforme sur toute sa longueur. L'alliage présente les caractéristiques souhaitées de super élasticité qui lui permettent de passer à un état martensitique provoqué par la tension, et de sortir de cet état, au fur et à mesure qu'on le fait progresser dans les lumières tortueuses dans le but de l'introduire dans les artères coronaires.
PCT/US1998/002790 1997-02-07 1998-02-09 Appareil et procede permettant une radiotherapie intravasculaire WO1998034681A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU63250/98A AU6325098A (en) 1997-02-07 1998-02-09 Apparatus and method for intravascular radiotherapy

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US79777197A 1997-02-07 1997-02-07
US08/797,771 1997-02-07

Publications (1)

Publication Number Publication Date
WO1998034681A1 true WO1998034681A1 (fr) 1998-08-13

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PCT/US1998/002790 WO1998034681A1 (fr) 1997-02-07 1998-02-09 Appareil et procede permettant une radiotherapie intravasculaire

Country Status (2)

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AU (1) AU6325098A (fr)
WO (1) WO1998034681A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10002057A1 (de) * 2000-01-18 2001-08-09 Stoll Hans Peter Brachytherapie-Kathetersystem

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4861520A (en) * 1988-10-28 1989-08-29 Eric van't Hooft Capsule for radioactive source
US5084002A (en) * 1988-08-04 1992-01-28 Omnitron International, Inc. Ultra-thin high dose iridium source for remote afterloader
US5111829A (en) * 1989-06-28 1992-05-12 Boston Scientific Corporation Steerable highly elongated guidewire
US5282781A (en) * 1990-10-25 1994-02-01 Omnitron International Inc. Source wire for localized radiation treatment of tumors
US5540659A (en) * 1993-07-15 1996-07-30 Teirstein; Paul S. Irradiation catheter and method of use

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5084002A (en) * 1988-08-04 1992-01-28 Omnitron International, Inc. Ultra-thin high dose iridium source for remote afterloader
US4861520A (en) * 1988-10-28 1989-08-29 Eric van't Hooft Capsule for radioactive source
US5111829A (en) * 1989-06-28 1992-05-12 Boston Scientific Corporation Steerable highly elongated guidewire
US5282781A (en) * 1990-10-25 1994-02-01 Omnitron International Inc. Source wire for localized radiation treatment of tumors
US5540659A (en) * 1993-07-15 1996-07-30 Teirstein; Paul S. Irradiation catheter and method of use

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10002057A1 (de) * 2000-01-18 2001-08-09 Stoll Hans Peter Brachytherapie-Kathetersystem

Also Published As

Publication number Publication date
AU6325098A (en) 1998-08-26

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