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WO1998040032A1 - Systeme et procede permettant d'administrer un traitement medical sur un site de traitement - Google Patents

Systeme et procede permettant d'administrer un traitement medical sur un site de traitement Download PDF

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Publication number
WO1998040032A1
WO1998040032A1 PCT/US1998/004611 US9804611W WO9840032A1 WO 1998040032 A1 WO1998040032 A1 WO 1998040032A1 US 9804611 W US9804611 W US 9804611W WO 9840032 A1 WO9840032 A1 WO 9840032A1
Authority
WO
WIPO (PCT)
Prior art keywords
transport tube
treatment
catheter
afterloader
hub
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.)
Ceased
Application number
PCT/US1998/004611
Other languages
English (en)
Inventor
Samuel F. Liprie
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.)
Angiorad LLC
Original Assignee
Angiorad LLC
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 Angiorad LLC filed Critical Angiorad LLC
Priority to AU65470/98A priority Critical patent/AU749886B2/en
Priority to JP53968998A priority patent/JP2001514560A/ja
Priority to EP98911536A priority patent/EP1006936A1/fr
Priority to CA002283994A priority patent/CA2283994A1/fr
Publication of WO1998040032A1 publication Critical patent/WO1998040032A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61N5/1007—Arrangements or means for the introduction of sources into the body
    • 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
    • A61N2005/1008—Apparatus for temporary insertion of sources, e.g. afterloaders

Definitions

  • the present disclosure relates to remote afterloading devices used to position radioactive treatment source wires inside patients afflicted with cancer or other diseases, and more particularly to a system and method for delivering a medical treatment to a treatment site of such patients.
  • Radioactive source or sources are positioned in the area needing treatment .
  • the radioactive sources are placed permanently inside the body during surgery, or transport tubes (treatment catheters) are placed in the body which are later temporarily loaded with radioactive sources.
  • This temporary afterloading of radioactive material either involves a human handling the radioactive material and receiving radiation exposure, or a machine called a "remote afterloader" that will load and unload the radioactive material into and from the transport tubes.
  • remote afterloaders are operated by an individual from a remote location so that the individual will not receive any radiation exposure.
  • a remote afterloader generally consists of a flexible simulation drive member, a flexible drive member containing a radioactive element, controllers and drive mechanisms to operate both types of flexible members, a shielding safe for the radioactive element, an internal timer, and an exit port attached to a rotating wheel that allows multiple transport tubes (previously placed into the patient) to be attached to device at the same time .
  • the afterloader sends out the radioactive source.
  • the afterloader retracts the source into the shielding safe inside the afterloader, a wheel turns and aligns a slot containing a second transport tube to an exit port .
  • the remote afterloader then repeats its function sending and retracting the simulation member and radioactive source through this second tube. The procedure is repeated until the function is carried out through all the specified transport tubes.
  • Existing remote afterloaders use a fixed, short length radioactive source and multi-step this source many times inside each transport tube to cover the diseased area.
  • angioplasty is used to open an artery or blood vessel in the region where the stenosis or the occlusion has occurred.
  • a typical angioplasty procedure consists of making a small incision through the body and into a blood vessel and then maneuvering a guide wire through the vascular system to a point beyond the stenosis or occlusion.
  • a hollow catheter with a declarable balloon near its distal end is threaded over the guide wire and advanced to the point of stenosis or occlusion.
  • the balloon is then inflated and deflated several times to widen the constricted area, and is then withdrawn from the body.
  • the angioplasty procedure does markedly reduce the area of stenosis or occlusion, many patients exhibit a reoccurrence of the stenosis within a few months of the original procedure .
  • the Weinstein et al patent describes a method and apparatus for preventing rustiness after angioplasty.
  • a balloon catheter transported by a conventional guide wire is delivered to the location of the stenosis.
  • Particles or crystals of radioactive material are embedded or mounted on a tube provided inside the balloon catheter.
  • a retractable radiation shielding sleeve is slidable along the tube to cover the source of radioactive material.
  • the shielding sleeve Upon completion of the angioplasty, the shielding sleeve is retracted and the area of the stenosis is irradiated.
  • this apparatus does introduce radiation to the point of the stenosis, the retractable shielding surrounding the source of radioactive material makes this catheter bulky and unwieldy to use. In this regard, it is very doubtful that a catheter system this bulky would fit into the smaller branches or vessels of the heart. It is also doubtful that a catheter this bulky and stiff could be maneuvered through the tighter bends and turns in many of the vessels .
  • An additional embodiment of the Weinstein et al . patent illustrates a sent which is made of or coated with a radioactive material such as iridium 192. Since the radioactive material is provided on the outer surface of the sent, it is very difficult to precisely administer the proper dosage of radiation to prevent hyperplasia without administering a level of radiation which would actually induce hyperplasia or other deleterious effects to the blood vessel.
  • the Shefer PCT application illustrates a method and apparatus for restenosis treatment by applying a radioactive dose to the stenosed region after reduction of the region by angioplasty or other means.
  • An angioplasty balloon is expanded in the vicinity of a lesion site and radioactive elements provided on the exterior surface of the balloon are forced into contact with the region. Therefore, similar to the Weinstein et al . patent, the presence of the radioactive material on the exterior of the catheter would make it very difficult to apply the precise amount of radiation to the region of interest.
  • both the Shefer PCT application and the Weinstein patent describe balloon catheters which do not allow the blood within the vessel to flow during inflation of the balloon. Although there have been some attempts to construct a dilatation balloon allowing for some perfusion of bodily fluids during the inflation phase of the dilatation, the perfusion is greatly diminished by the overall size of the inflated balloon.
  • Dilatation balloons must be able to hold a great amount of pressure (up to 16 atmospheres) and must also be able to inflate to large overall diameters to open the stenosis areas inside the bodily conduits or narrow tortuous passageways. Both of these requirements lead to large, bulky dilatation balloons that encompass most, if not all, of the area inside the stenosed vessel leading to large blockages of bodily fluids and thus allowing for little, if any perfusion. Examples of these types of balloons are described in U.S. Patent Nos . 5,295,959, issued to Gurbel et al and 5,308,356, issued to Blackshear, Jr. et al .
  • Both of these patents describe a passive perfusion dilatation catheter having a series of non- longitudinal lobes. As particularly illustrated in the Blackshear, Jr. et al patent, virtually the entire interior of the bodily conduit is blocked when the dilatation balloon is inflated, thereby preventing the flow of bodily fluids around the treatment site. Additionally, due to the particular structure of the balloons utilized, neither the Gurbel et al . nor the Blackshear, Jr. et al . balloon can be used to precisely position the catheter within the bodily conduit at the site of treatment.
  • the present disclosure addresses the deficiencies of previous devices by treating the location of a stenosis in a blood vessel, or other hollow conduit or narrow tortuous passageway in the body by utilizing a dilatation balloon (or series of balloons) in conjunction with a stand-off balloon (or series of balloons) , both of which are attached near distal end of a catheter.
  • a radiopaque elongated, flexible guidewire is inserted into the body through a small incision and is then introduced into a blood vessel or similar conduit or passageway. Once in place, a catheter including the aforementioned dilatation balloon or balloons as well as one or more stand-off balloons would be maneuvered to the location of treatment .
  • the dilatation balloon or balloons is inflated and deflated one or more times to reduce the size of the stenosis.
  • the stand-off balloon or balloons would be inflated. Since the stand-off balloons inflate symmetrically and are long with thin widths, they serve to position the treatment lumen of the catheter inside the prior stenosised area while allowing for maximum bodily perfusion.
  • a radioactive source or sources is advanced into position through the treatment lumen of the catheter to the site of the original stenosis. With the stand-off balloon or balloons inflated, the catheter and the radioactive source or sources are correctly positioned within the bodily conduit or passageway to administer the precise dose to the original area of the stenosis. After a predetermined period of time has elapsed, the stand-off balloon or balloons are deflated and the radioactive source as well as the catheter and a guidewire are removed from the bodily conduit or passageway.
  • a normal angioplasty catheter including the catheter utilizing both dilatation as well as stand-off balloons are provided in a sterile package and is used entirely in a sterile environment to prevent contamination from being introduced into the patient's body.
  • the treatment channel or lumen of the aforementioned catheter is positioned within the catheter and contains an inner, closed channel.
  • a radioactive source or sources is maneuvered from an afterloader through this channel until it nears the closed end to deliver therapy within the patient's body.
  • the present disclosure is directed to a treatment catheter allowing a radioactive source or sources to be maneuvered from an afterloader in a non-sterile environment into a sterile environment without the occurrence of contamination.
  • a catheter employing both stand-off as well as dilatation balloons are placed into the patient ' s body, it is important that the portion of the treatment lumen from the balloon inflation channel or channels to the distal end of the catheter provided within the patient's body, must all be contained within a working sterile environment. It is noted that for purposes of explanation, the present disclosure is described with respect to a catheter employing both dilatation as well as stand-off balloons. However, as can be appreciated by practitioners in the medical art, it is not necessary to utilize this type of catheter to practice the teachings of the present disclosure.
  • a radioactive source or sources can be loaded into the opening of the transport tube.
  • One method is to physically load the source or sources by hand or by the use of forceps or other types of manipulators into the treatment channel.
  • the second method is to load the source or sources by use of the remote afterloader.
  • a specially designed hub provided on the proximal end of the transport tube must be utilized. This hub design contains a tapered or funnel opening to allow the radioactive source or sources to

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Radiation-Therapy Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Electrotherapy Devices (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un système permettant d'administrer un traitement médical sur un site de traitement dans un vaisseau ou un autre conduit situé dans un corps de mammifère, lequel système comprend: un dispositif de chargement différé (28) composé d'un boîtier, d'un organe d'entraînement, d'un conduit (56) possédant une première extrémité fonctionnellement associée à une partie de sortie de l'organe d'entraînement, et d'un connecteur (44) placé à une seconde extrémité, ledit connecteur définissant une première surface de jointement; un tube de transport allongé (24) possédant une extrémité proximale définissant une deuxième surface de jointement, la première et la deuxième surface de jointement étant configurées de manière complémentaire et calibrées de manière qu'un passage continu est formé entre le conduit et le tube de transport allongé; et un élément de verrouillage (58) de position à l'intérieur d'un canal formé adjacent à la première ou à la seconde surface de jointement, lequel élément de verrouillage (58) est configuré et calibré de manière qu'en insérant l'élément de verrouillage dans le canal, on accouple solidement la première et la deuxième surface de jointement.
PCT/US1998/004611 1997-03-11 1998-03-10 Systeme et procede permettant d'administrer un traitement medical sur un site de traitement Ceased WO1998040032A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU65470/98A AU749886B2 (en) 1997-03-11 1998-03-10 System and method for delivering a medical treatment to a treatment site
JP53968998A JP2001514560A (ja) 1997-03-11 1998-03-10 医療治療を患部に施すためのシステム及び方法
EP98911536A EP1006936A1 (fr) 1997-03-11 1998-03-10 Systeme et procede permettant d'administrer un traitement medical sur un site de traitement
CA002283994A CA2283994A1 (fr) 1997-03-11 1998-03-10 Systeme et procede permettant d'administrer un traitement medical sur un site de traitement

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US81421397A 1997-03-11 1997-03-11
US08/814,213 1997-03-11

Publications (1)

Publication Number Publication Date
WO1998040032A1 true WO1998040032A1 (fr) 1998-09-17

Family

ID=25214447

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/004611 Ceased WO1998040032A1 (fr) 1997-03-11 1998-03-10 Systeme et procede permettant d'administrer un traitement medical sur un site de traitement

Country Status (5)

Country Link
EP (1) EP1006936A1 (fr)
JP (1) JP2001514560A (fr)
AU (1) AU749886B2 (fr)
CA (1) CA2283994A1 (fr)
WO (1) WO1998040032A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL1020740C2 (nl) * 2002-06-03 2003-12-08 Nucletron Bv Werkwijze en inrichting voor het tijdelijk inbrengen en plaatsen van tenminste een energie uitstralende bron in een dierlijk lichaam.

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4851694A (en) * 1987-01-28 1989-07-25 Campaignie ORIS Industrie Device for driving and positioning a source holder in an applicator used in radiotherapy
US5213561A (en) * 1990-09-06 1993-05-25 Weinstein Joseph S Method and devices for preventing restenosis after angioplasty
US5605530A (en) * 1995-03-23 1997-02-25 Fischell; Robert E. System for safe implantation of radioisotope stents

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4851694A (en) * 1987-01-28 1989-07-25 Campaignie ORIS Industrie Device for driving and positioning a source holder in an applicator used in radiotherapy
US5213561A (en) * 1990-09-06 1993-05-25 Weinstein Joseph S Method and devices for preventing restenosis after angioplasty
US5605530A (en) * 1995-03-23 1997-02-25 Fischell; Robert E. System for safe implantation of radioisotope stents

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL1020740C2 (nl) * 2002-06-03 2003-12-08 Nucletron Bv Werkwijze en inrichting voor het tijdelijk inbrengen en plaatsen van tenminste een energie uitstralende bron in een dierlijk lichaam.
EP1369143A1 (fr) * 2002-06-03 2003-12-10 Nucletron B.V. Procédé et appareil pour l'insertion et le positionnement temporaire d'au moins une source d'irradiation dans le corps humain ou animal
US7267643B2 (en) 2002-06-03 2007-09-11 Nucletron B.V. Method and apparatus for temporarily inserting and positioning at least one energy emitting source in an animal body

Also Published As

Publication number Publication date
EP1006936A1 (fr) 2000-06-14
AU6547098A (en) 1998-09-29
AU749886B2 (en) 2002-07-04
JP2001514560A (ja) 2001-09-11
CA2283994A1 (fr) 1998-09-17

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