+

WO1997048452A1 - Catheter radioactif en rhenium - Google Patents

Catheter radioactif en rhenium Download PDF

Info

Publication number
WO1997048452A1
WO1997048452A1 PCT/IL1997/000181 IL9700181W WO9748452A1 WO 1997048452 A1 WO1997048452 A1 WO 1997048452A1 IL 9700181 W IL9700181 W IL 9700181W WO 9748452 A1 WO9748452 A1 WO 9748452A1
Authority
WO
WIPO (PCT)
Prior art keywords
rhenium
radioactive
catheter
wire
group
Prior art date
Application number
PCT/IL1997/000181
Other languages
English (en)
Inventor
Efraim Lavie
Original Assignee
The State Of Israel, Atomic Energy Commission Soreq Nuclear Research Center
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 The State Of Israel, Atomic Energy Commission Soreq Nuclear Research Center filed Critical The State Of Israel, Atomic Energy Commission Soreq Nuclear Research Center
Priority to EP97925250A priority Critical patent/EP0921843A1/fr
Publication of WO1997048452A1 publication Critical patent/WO1997048452A1/fr

Links

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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1282—Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
    • 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

Definitions

  • the present invention relates to a device for local irradiation treatment within a tubular organ.
  • the present invention relates to a local irradiation treatment within arteries for the purpose of prophylaxis of restenosis, e.g. such which may occur following balloon angioplasty.
  • balloon angioplasty a catheter equipped at its distal end with a dilatable balloon is inserted intravascularly to a site of an atherosclerotic occlusion. Inflation of the balloon presses the surrounding walls of the blood vessels while stretching them and thus widening the atherosclerotic site.
  • a treatment is usually effective in initial stretching of the walls of the blood vessel, restenosis resulting from the growth of smooth muscle cells at this site often occurs.
  • reapplying balloon angioplasty in order to widen the blood vessel is usually ineffective and surgery is then usually the only available treatment.
  • Stents have in recent years gained popularity as an angioplasty aid. Stents, which are helical devices, can be inserted at an atherosclerotic site following angioplasty, and they then form a physical barrier against restenosis. However, even the use of stents only partially inhibits restenosis and often, notwithstanding the existence of the stent, there is growth of smooth muscle cells into the lumen, which eventually blocks the blood vessel. Another method of inhibiting the occurrence of restenosis known in the art is radioactive irradiation of the atherosclerotic site.
  • U.S. Patent 5,059,166 discloses a tubular intra-arterial stent which is made of a radioactive material. The stent in addition to supporting the wall of the blood vessel, also serves to locally irradiate the tissue thus reducing the proliferative capacity of the smooth muscle cells.
  • U.S. Patent 5,199,939 discloses a device comprising a flexible carrier which can be inserted into a blood vessel, having a radioactive source located at a distal section of the carrier.
  • the radioactive source disclosed in this U.S. patent is a ⁇ emitter, Iridium 192.
  • the use of Iridium 192 in the operation or catherization theater is complicated in view of the protective equipment required for dealing with the radioactive source.
  • Iridium 192 in the operation or catherization theater is complicated in view of the protective equipment required for dealing with the radioactive source.
  • a reluctance of medical personnel to deal with ⁇ emitters are today.
  • the present invention provides, by a first of its aspects, a device for local irradiation of walls of a tubular organ, comprising a metallic O 97/48452 PCML97/00181
  • the device of the invention can be implemented for local irradiation in a variety of tubular organs. Local irradiation within a blood vessel to inhibit restenosis is a preferred, albeit not exclusive, embodiment of the invention. As will be appreciated, the device may also be adopted for local irradiation of other tubular organs.
  • Rhenium 186 and Rhenium 188 are radioactive materials which are primarily a /3-emitter.
  • the advantage of a /3-emitter over a ⁇ -emitter used in prior art devices such as that of U.S. Patent 5,199,939, is, that ⁇ - radiation has a limited depth of penetration into biological tissues, in the order of millimeters.
  • Rhenium 186 or Rhenium 188 will be chosen based on the desired irradiation intensity. For example, for irradiating walls of a blood vessel in order to inhibit the occurrence of restenosis, the radiation will be in the range of 1,000-2,500 cGy. According to a preferred embodiment of the invention, the insertable member radiates at 1,400-2,000 cGy measured at a distance of 2 mm from the longitudinal axis of the device.
  • the device is inserted into a blood vessel at a site of occlusion following its widening, e.g. by balloon angioplasty, and is then maintained at that site for a time required for the surrounding tissue to absorb a quantity of irradiation sufficient to inhibit subsequent growth of smooth muscle cells at that site.
  • the device is a wire, e.g. made of nitinol (nickel-titanium alloy) having a portion at a distal end, e.g. of a length of about 2-3 cm, comprising Rhenium 186. This portion may be a Rhenium piece welded to the wire or may be a distal portion of the wire coated by Rhenium 186 or Rhenium 188.
  • the device is a wire, e.g. nitinol wire, having a distal portion carrying several short cylindrical portions made of or comprising Rhenium 186.
  • the distal portion may for example be about 2-4 cm long and carry several, e.g. 6-8 small cylindrical pieces, each one of a length of about 2-3 mm.
  • the device is a wire according to one of the above two embodiments, enclosed within a catheter, e.g. a balloon catheter, with the radioactive portions being within the distal portion of the catheter.
  • a catheter e.g. a balloon catheter
  • the radioactive portion is typically contained beneath the inflatable (balloon) portion.
  • the device is a stent, e.g. carried on a balloon catheter, having Rhenium 186 or Rhenium 188 comprising portions or being at least partially coated by Rhenium 186 or Rhenium 188.
  • the device comprises a catheter holding Rhenium 186 or Rhenium 188 at a distal portion thereof, e.g. in a capsule or an enclosure within a distal portion of the catheter.
  • the Rhenium 186 or Rhenium 188 may be in the form of powder, in the form of small spheres, rods, etc.
  • the Rhenium 186 or Rhenium 188 may also be in the form of a small particulate solids, e.g. in suspension, a solution, e.g. an aqueous solution of perrehenate (such as 186 ReO 4 " ), or may be linked to a complexing or chelating agent, etc.
  • a Rhenium 186 or Rhenium 188 comprising member is at a distal portion of a device insertable within a tubular organ, are all encompassed within the framework of the invention.
  • a method of preventing restenosis in a portion of a blood vessel comprising:
  • the present invention also provides a method of preparing such a device.
  • the method comprises:
  • steps (a) and (b) i.e. first irradiating a non-radioactive Rhenium to convert at least part of the Rhenium to Rhenium 186 and then incorporating the obtained Rhenium 186 within the device.
  • the irradiation may be carried out, for example, by using a flux of neutrons of about 10 13 to 5xl0 13 N/cm 2 /sec for 0.5-10 hrs.
  • Rhenium 186 or Rhenium 188 are advantageous in that they have a relatively short half life of 3.78 days and 17 hours respectively, and accordingly there is only a limited internal exposure to radioactive irradiation.
  • a shield constitutes an aspect of the invention.
  • the shield typically comprises a casting made of radioactive impermeable material, e.g. lead, and a receiver within the container adapted to hold said device or at least the radioactive portion thereof.
  • Fig. l(A-E) show several embodiments of devices in accordance with the invention.
  • Fig. 2 shows a longitudinal cross section through a shield in accor- dance with the invention.
  • Fig. IA shows a device in accordance with the invention comprising a wire 10 e.g. made of nitinol, having a portion 12 at a distal end thereof, comprising Rhenium 186 or Rhenium 188.
  • This portion may be a Rhenium 186 or Rhenium 188 piece welded to said wire 10, a portion coated by Rhenium 186 or Rhenium 188, etc.
  • a specific example of portion 12 is shown in Fig. IB.
  • Portion 12 comprises a wire 10', being an extension of wire 10 (Fig. IA) and carries a plurality of short cylindrical pieces 13 made of or comprising Rhenium 186 or Rhenium 188.
  • Portion 12 may for example be about 3 cm long and the plurality of pieces 13 (seven in this specific embodiment) may be each about 2 cm long. Such an arrangement may be helpful in overcoming the problem of rigidity of one long Rhenium member.
  • these segments are not limited to cylinders but may be of any other shape, e.g. spheres.
  • the device shown in Fig. 1C comprises a wire 14, which may be similar to that of Fig. IA, having a radioactive portion 16 at its front end which is comprised of a member selected from the group consisting of
  • Rhenium 186 and Rhenium 188 Wire 14 is held within a catheter 18, having a distal portion e.g. which is inflatable (represented by dotted line).
  • the device is a stent 20 mounted on a balloon catheter
  • the stent is made primarily from nitinol but is coated with a metallic coating comprising a member selected from the group consisting of Rhenium 186 and Rhenium 188.
  • Fig. IE it shows a catheter 24 having a balloon portion 26, containing in its lumen an enclosure 28. This enclosure may hold powder of Rhenium 186 or Rhenium 188, small spheres of Rhenium
  • Rhenium 188 or a solution comprising a Rhenium 186 or Rhenium 188 compound or complex, e.g. a solution comprising 18fi ReO 4 '.
  • Figs. 1A-1E are particularly the devices of Figs. 1C and ID, are intended primarily for insertion into a blood vessel. It is however understood that the illustrated embodiments are but an example, and the invention is applicable mutatis mutandis, also to local irradiation within other tubular organs, e.g. digestion tracts, respiratory tracts, etc.
  • the device shown in Fig. IA may be inserted into an artery so that portion 12 will be placed at a previously occluded site where restenosis may be expected. It is then retained within the artery for a time sufficient to administer the required irradiation dose to the surrounding tissue.
  • a device such as that shown in Fig. IA is inserted into the site typically after but at times also before balloon angioplasty.
  • a device such as that shown in Fig. 1C
  • the fact that it is incorporated within a balloon catheter enables irradiation at the time of balloon angioplasty which saves time and procedure complexity.
  • the balloon portion of the catheter is inflated, the constricted tissue widens and at the same time, as well as after deflation of the balloon and as long as the catheter is maintained in place, radioactive portion 16 irradiates the previously occluded site.
  • Fig. ID which has the form of stent 20
  • it is typically coated with a coating comprising Rhenium 186 or Rhenium 188.
  • the coating may be applied on the entire stent or only on a portion thereof.
  • the stent may be placed at the site for a prolonged period of time but in the first few days, the required irradiation dose will be administered to the surrounding tissues to help in inhibiting restenosis. The irradiation effect will occur until a substantially complete decay of the radioactive Rhenium 186 or Rhenium 188 is obtained.
  • Fig. 2 showing a shield 30 for shielding the radioactive portion of the device.
  • the shield comprises a lead casing 32 and an internal medium 34 made from a plastic material such as PVC.
  • Medium 34 has a central longitudinal bore 36 which accommodates and holds the end of a wire 38 which contains the hot Rhenium wire portion 40.
  • the container is sealed by a lead lid 42 which defines a duct or a lumen accommodating portion of the wire.
  • Rhenium wire having 0.5 mm diameter and weighing about 120 mg was irradiated for 30 minutes at a thermal neutron flux of about 4.5X10 13 N/c ⁇ r/sec.
  • Typical gamma spectrum lines were: E ( ⁇ ) 137 KeV with a frequency of 8.65%;

Landscapes

  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Optics & Photonics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Radiology & Medical Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

L'invention concerne un dispositif et un procédé pour l'irradiation locale des parois d'un organe tubulaire comprenant un instrument métallique radioactif doté d'un élément choisi dans le groupe du rhénium 186 et du rhénium 188, insérable dans ledit organe tubulaire.
PCT/IL1997/000181 1996-06-17 1997-06-09 Catheter radioactif en rhenium WO1997048452A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP97925250A EP0921843A1 (fr) 1996-06-17 1997-06-09 Catheter radioactif en rhenium

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL11866996A IL118669A (en) 1996-06-17 1996-06-17 Radioactive catheter
IL118669 1996-06-17

Publications (1)

Publication Number Publication Date
WO1997048452A1 true WO1997048452A1 (fr) 1997-12-24

Family

ID=11068978

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL1997/000181 WO1997048452A1 (fr) 1996-06-17 1997-06-09 Catheter radioactif en rhenium

Country Status (4)

Country Link
EP (1) EP0921843A1 (fr)
CA (1) CA2258631A1 (fr)
IL (1) IL118669A (fr)
WO (1) WO1997048452A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19758234A1 (de) * 1997-12-30 1999-07-08 Puthawala Anwer Radioaktiver Katheter
EP0963182A1 (fr) * 1996-09-26 1999-12-15 The Trustees Of Columbia University In The City Of New York Procede pour traiter un processus pathologique dans une structure luminale
EP1048325A2 (fr) 1999-04-30 2000-11-02 Mallinckrodt Inc. Dispositif d'admission pour la manipulation de liquide radioactif
WO2000032273A3 (fr) * 1998-12-01 2000-11-16 Electroformed Stents Inc Extenseurs radioactifs a dilatation uniforme
EP0857470B1 (fr) * 1997-01-09 2006-07-19 Sorin Biomedica Cardio S.R.L. Procédé de production d'un stent pour angioplastie

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5059166A (en) * 1989-12-11 1991-10-22 Medical Innovative Technologies R & D Limited Partnership Intra-arterial stent with the capability to inhibit intimal hyperplasia
US5199939A (en) * 1990-02-23 1993-04-06 Dake Michael D Radioactive catheter
WO1994023789A1 (fr) * 1993-04-13 1994-10-27 Mallinckrodt Medical, Inc. Dispositif pour introduire une source radioactive dans le corps
US5452720A (en) * 1990-09-05 1995-09-26 Photoelectron Corporation Method for treating brain tumors
WO1995033512A1 (fr) * 1994-06-08 1995-12-14 Liprie Samuel F Fil metallique source flexible pour le traitement par rayonnements
WO1996002059A1 (fr) * 1994-07-12 1996-01-25 Photoelectron Corporation Appareil a rayons x appliquant un flux predetermine sur une surface interne d'une cavite du corps
WO1996010436A1 (fr) * 1994-09-30 1996-04-11 Liprie Samuel F Catheter de mise en place d'un fil de radiotherapie dans le site de traitement
US5605671A (en) * 1992-10-05 1997-02-25 The Regents Of The University Of Michigan Radiolabeled neutrophil activating peptides for imaging

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5059166A (en) * 1989-12-11 1991-10-22 Medical Innovative Technologies R & D Limited Partnership Intra-arterial stent with the capability to inhibit intimal hyperplasia
US5199939A (en) * 1990-02-23 1993-04-06 Dake Michael D Radioactive catheter
US5199939B1 (en) * 1990-02-23 1998-08-18 Michael D Dake Radioactive catheter
US5452720A (en) * 1990-09-05 1995-09-26 Photoelectron Corporation Method for treating brain tumors
US5605671A (en) * 1992-10-05 1997-02-25 The Regents Of The University Of Michigan Radiolabeled neutrophil activating peptides for imaging
WO1994023789A1 (fr) * 1993-04-13 1994-10-27 Mallinckrodt Medical, Inc. Dispositif pour introduire une source radioactive dans le corps
WO1995033512A1 (fr) * 1994-06-08 1995-12-14 Liprie Samuel F Fil metallique source flexible pour le traitement par rayonnements
WO1996002059A1 (fr) * 1994-07-12 1996-01-25 Photoelectron Corporation Appareil a rayons x appliquant un flux predetermine sur une surface interne d'une cavite du corps
WO1996010436A1 (fr) * 1994-09-30 1996-04-11 Liprie Samuel F Catheter de mise en place d'un fil de radiotherapie dans le site de traitement

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0963182A1 (fr) * 1996-09-26 1999-12-15 The Trustees Of Columbia University In The City Of New York Procede pour traiter un processus pathologique dans une structure luminale
EP0963182A4 (fr) * 1996-09-26 2000-10-18 Univ Columbia Procede pour traiter un processus pathologique dans une structure luminale
US6306073B1 (en) 1996-09-26 2001-10-23 The Trustees Of Columbia University In The City Of New York Apparatus and method for treating a disease process in a luminal structure with a radionuclide and chelating agent
EP0857470B1 (fr) * 1997-01-09 2006-07-19 Sorin Biomedica Cardio S.R.L. Procédé de production d'un stent pour angioplastie
DE19758234A1 (de) * 1997-12-30 1999-07-08 Puthawala Anwer Radioaktiver Katheter
DE19758234C2 (de) * 1997-12-30 2003-04-17 Anwer Puthawala Verwendung eines radioakten Katheters
WO2000032273A3 (fr) * 1998-12-01 2000-11-16 Electroformed Stents Inc Extenseurs radioactifs a dilatation uniforme
EP1048325A2 (fr) 1999-04-30 2000-11-02 Mallinckrodt Inc. Dispositif d'admission pour la manipulation de liquide radioactif

Also Published As

Publication number Publication date
IL118669A (en) 2000-02-17
CA2258631A1 (fr) 1997-12-24
IL118669A0 (en) 1996-10-16
EP0921843A1 (fr) 1999-06-16

Similar Documents

Publication Publication Date Title
US5924973A (en) Method of treating a disease process in a luminal structure
US5840008A (en) Radiation emitting sleeve catheter and methods
KR100228188B1 (ko) 방사성 스텐트 및 그의 제조방법
US6547816B1 (en) Formable integral source material for medical devices
JPH11505435A (ja) 血管形成術を施した後の血管の再狭窄を阻止するためのバルーンカテーテルおよびこのバルーンカテーテルを造るための方法
CA2323440A1 (fr) Composition pouvant etre radioactivee convenant pour la fabrication de dispositifs medicaux implantables
EP2070493A1 (fr) Stent creux pouvant transporter une source ultra-miniaturisée de particules radioactives
US20060178736A1 (en) Stent for neutron capture therapy and method of manufacture therefor
JPS62501565A (ja) Ｘ線放射性間質插入物
WO1999001179A1 (fr) Source de rayonnement comprenant un fil d'apport
JP2002522184A (ja) 放射線治療の装置および方法
CA2385369C (fr) Source de rayonnement sous forme de cable pour radiotherapie endovasculaire
EP1284684A2 (fr) Composition pouvant etre radioactivee convenant pour la fabrication de dispositifs medicaux implantables
WO2005023367A2 (fr) Source de curietherapie a debit de dose eleve emettant des rayons x et des rayons gamma
US6400796B1 (en) X-ray emitting sources and uses thereof
EP0921843A1 (fr) Catheter radioactif en rhenium
Weinberger Intracoronary radiation using radioisotope solution-filled balloons
WO1999022812A1 (fr) Source de rayonnement solide a generation in situ a base de tungstene188/rhenium188 et son utilisation
CA2372786C (fr) Materiau source integral faconnable pour dispositifs medicaux et industriels
US6500108B1 (en) Radiation delivery system and method
Joh et al. Measurement of radiation absorbed dose in endovascular Ho-166 brachytherapy using a balloon angio-catheter
Dale et al. Applications of thermal neutron generators driven with a repetitively pulsed electron linac
WO2000059550A2 (fr) Indium 114m utilise comme source de curietherapie, et compositions et procedes correspondants
福田篤志 et al. Exposure doses of interventional cardiologist during intracoronary radiotherapy with phosphorus-32
Regar et al. Vascular Brachytherapy

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): CA US

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FI FR GB GR IE IT LU MC NL PT SE

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
121 Ep: the epo has been informed by wipo that ep was designated in this application
ENP Entry into the national phase

Ref document number: 2258631

Country of ref document: CA

Ref country code: CA

Ref document number: 2258631

Kind code of ref document: A

Format of ref document f/p: F

WWE Wipo information: entry into national phase

Ref document number: 1997925250

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1997925250

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1997925250

Country of ref document: EP

点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载