WO1994023789A1 - Dispositif pour introduire une source radioactive dans le corps - Google Patents

Dispositif pour introduire une source radioactive dans le corps Download PDF

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Publication number
WO1994023789A1
WO1994023789A1 PCT/US1994/004213 US9404213W WO9423789A1 WO 1994023789 A1 WO1994023789 A1 WO 1994023789A1 US 9404213 W US9404213 W US 9404213W WO 9423789 A1 WO9423789 A1 WO 9423789A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
iridium
flexible cable
reservoir
radioactive source
Prior art date
Application number
PCT/US1994/004213
Other languages
English (en)
Inventor
Wim Borneman
Original Assignee
Mallinckrodt Medical, Inc.
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 Mallinckrodt Medical, Inc. filed Critical Mallinckrodt Medical, Inc.
Priority to AU67062/94A priority Critical patent/AU6706294A/en
Priority to EP94914813A priority patent/EP0695204A4/fr
Priority to JP6523503A priority patent/JPH08509143A/ja
Publication of WO1994023789A1 publication Critical patent/WO1994023789A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002Intraluminal radiation therapy
    • GPHYSICS
    • G21NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21GCONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
    • G21G4/00Radioactive sources
    • G21G4/04Radioactive sources other than neutron sources
    • G21G4/06Radioactive sources other than neutron sources characterised by constructional features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/10X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N2005/1019Sources therefor
    • A61N2005/1025Wires

Definitions

  • the invention relates to a device for introducing a source of radioactive radiation into the body for therapeutic application, and to a capsule for said device.
  • Such a device is known from United States Patent Specification 3,750,653.
  • This Patent Specification discloses a thin-walled, narrow tube which is closed at its front end and which can be introduced into the human body. The rear end portion stays outside the body, so that after positioning the tube, a source of radioactive material can be introduced into the tube.
  • This known device shows many disadvantages, such as discomfort in use, inaccurate positioning of the source, impossibility of deep penetration into the body, and the use of plastic source-covering material unfit for accommodating a radioactive source.
  • U.S. Patent 4,861,520 overcomes several of the above problems noted above, and provides a device for introducing a source of radioactive radiation into the body for therapeutic application which satisfies the following conditions: (i) it is possible to position the source of radiation accurately with respect to the tumour to be treated; (ii) the source of radiation is safely enclosed in a metal capsule which is resistant to the radioactive radiation; and (iii) the device is generally applicable, i.e. is also usable in the radiotherapeutic treatment of those tumours which are difficult of access, in particular lung tumours and tumours in those internal organs which are accessible for catheterization through the bloodstream or percutaneously.
  • the device described in U.S. Patent 4,861,520 comprises a flexible cable which can be introduced into the body through a catheter and which at its front end is coaxially provided with a capsule, sealingly accommodating iridium-192 in such a quantity that its activity capacity is sufficient for therapeutic application.
  • the capsule comprises a thin- walled tubular reservoir, one end being sealingly connected to the flexible cable and a second end being closed and having a round-off external shape.
  • the cable must be flexible so as to be able to follow the track of the catheter.
  • a solid end portion on which information regarding the nature of the radiation source may be provided, if so desired.
  • Cable and capsule coaxially connected thereto are proportioned so that they can be manoeuvred to the desired position through a catheter already provided in the body. This is of great importance because almost any place in the body is accessible for a catheter, such as body cavities, and other places in the body.
  • the flexibility of the cable enables the radiation source to reach places in the body which are difficult to access, in particular the deeper-situated parts of the respiratory system, as well as other internal organs, for example, liver and kidneys, which can be reached by means of a catheter either through the bloodstream or percutaneously.
  • the length of the capsule connected axially to the cable is of essential importance, because the capsule must be manufactured of metal and is therefore rigid.
  • Still a disadvantage of the known devices is that a number of procedures has to be performed with the "hot" capsule, i.e. the capsule already containing the radioactive source.
  • the handling of dangerous radioactive material during such procedures may promote a less stringent accuracy in quality control and the admittance of higher tolerances, resulting in products with a suboptimal quality.
  • Examples of such procedures are the radioactivity measuring of the individual pellets or bar of radioactive material, the packing thereof into the capsule, the sealing of the ampoule, e.g. by welding, to accommodate the radioactive material therein, and the usual testing of the "hot" capsule, e.g. by proving the gastightness thereof.
  • a therapeutic device for introducing a source of radioactive radiation into a body comprising: a flexible cable which can be introduced into the body through a catheter; and a capsule for sealingly containing a radioactive source, said capsule comprising a thin-walled tubular reservoir coaxially connected to the flexible cable; which device is characterized according to the present invention in that the capsule is manufactured of titanium.
  • a titanium capsule can be used without any objection as a cover for the inactive material, allowing said inactive material within the capsule to be converted into the desired radioactive material by irradiation with thermal neutrons in a reactor. Therefore, the titanium capsule can be filled with the inactive material, then sealingly closed and subjected to the procedures as indicated above, e.g. a gastightness test. Thereupon the capsule is irradiated to convert its inactive contents into the radioactive material, in this manner constituting the desired source of radioactive radiation. Connection of the irradiated capsule to the flexible cable produces the final device, having the intended radioactivity (radiation activity).
  • a capsule made of titanium lends itself excellently to a rigid and reliable connection to the flexible cable, preferably by using a technique of welding.
  • the reservoir of the capsule preferably has an open end, which is sealingly connected to the flexible cable, and a closed end with a rounded-off external shape.
  • the bottom of the capsule can be reduced to a thickness of only
  • such a capsule is provided with a plug, hermetically sealing the open end of the capsule and connectable to the flexible cable, preferably by welding as indicated above.
  • Said plug has a reduced central portion, extending into the open end of the reservoir and sealing same. It has been found, that this central portion can be reduced to a length of only 0.1 mm to still be able to perform its sealing function.
  • the flexible cable is manufactured of a mechanically strong but flexible material, preferably of stainless steel.
  • the cable is preferably composed of a bundle of twisted steel strands.
  • the outside diameter of the reservoir and the diameter of the flexible cable are approximately 1.1 mm at most. Such a device can easily be introduced into the body through a catheter with an internal diameter of 1.3 mm.
  • the wall thickness of the tubular reservoir taken into account, such a reservoir has an inside diameter of approx. 0.7 mm.
  • the length of the capsule reservoir should be optimized, keeping in mind that the shorter the rigid capsule the better the manoeuvrability of the device in the body of the patient.
  • the capsule may comprise a plurality of iridium-192 pellets as the radioactive source but, in order to minimize the length of the reservoir, preferably comprises a single bar of this radioactive material.
  • a radioactive source with an activity of 11.2 Curie can be obtained, using a capsule with a reservoir internally dimensioned 0.7 x 3.8 mm, or if desired, of 13.6 Curie, using a capsule with a reservoir internally dimensioned 0.7 x 4.5 mm.
  • the invention also relates to a capsule for a device as defined hereinbefore, said capsule being adapted for sealingly containing a radioactive source, and which capsule is manufactured from titanium.
  • the radioactive source to be accommodated in said capsule comprises preferably iridium-192, in the form of a plurality of pellets or as a single bar,
  • said capsule comprises a plurality of iridium pellets, pressed iridium powder or a single bar of iridium, from which the radioactive source (iridium-192) is formed by irradiation.
  • the irradiation of the inactive material viz. iridium-191 does not influence the titanium wall of the capsule so that the proper functioning of the ready device is not disturbed.
  • said inactive material is enriched iridium-191 in order to be able to minimize the internal volume of the capsule reservoir.
  • Figure 1 is a longitudinal sectional view of a preferred embodiment of a device according to the invention, prior to connection of the capsule to the cable,
  • Figure 2 shows on an exaggerated scale a part of the device shown in Figure 1, viz. the part encircled at A
  • Figure 3 shows a longitudinal sectional view of a further preferred embodiment of a device according to the invention, now in a ready-for-use condition.
  • the device for introducing a source of radioactive radiation into the body for therapeutic application is formed and dimensioned as the device shown in the above- mentioned WO 92/00776.
  • the device comprises a flexible cable 10, having at its rear end a solid portion 11, and a separate capsule 12, that can be connected to the front end of the cable by welding.
  • the flexible cable is twisted from a large number of strands of stainless steel.
  • the cable has a diameter of approx. 1.1 mm.
  • a single bar 14 of inactive iridium is enclosed in the capsule 12.
  • the capsule consists of a thin-walled tubular reservoir of titanium having an externally rounded-off distal portion 15 which is present at the front end.
  • the open proximal end of the reservoir is sealed by means of a plug, equally made of titanium.
  • the plug includes a first portion 16 having a reduced diameter extending within the tubular reservoir, which keeps the inactive material enclosed within the reservoir and tightly fits within the wall 17 of the reservoir.
  • a second portion 18 of the plug is formed integrally with first portion 16 and bears with its outer edge or flange on the rear edge of the wall 17 of the reservoir.
  • the flange and the wall of the reservoir are circumferentially welded together by a weld 19, for example by electron beam welding, laser welding or orbital welding, so that a reliable and hermetic seal of the reservoir is obtained.
  • the capsule containing the iridium is irradiated by thermal neutrons in a reactor, resulting in the capsule enclosing the radioactive source of iridium-192. Then the plug of the capsule is connected to the flexible cable by welding it at the prepared forward end 13 of the cable, also, for example, by laser welding, electron beam welding or orbital welding.
  • a tubular reservoir having an external length of approx. 5.0 mm, measured from the front end of distal portion 15 to the rear edge of the flange of the second portion 18 of the plug, i.e. to the end of the prepared end of the cable, and having an outside diameter of approx. 1.1 mm, is optimum, because such dimensions provide sufficient space for a quantity of radioactive material, in particular a single bar of iridium-192, with a radioactivity capacity of 11.2 Curie.
  • the internal dimensions of the capsule reservoir are then 0.7 x 3.8 mm.
  • radioactivity capacity of even 13.6 Curie can be realized.
  • Such quantities of radioactivity are extremely suitable for the radiation treatment of tumours of internal organs, for example, lung tumours.
  • the radioactivity capacities obtained by irradiation of inactive iridium enclosed within the titanium capsule viz. the above 11.2 and 13.6 Curie respectively, are the same as can be realized by irradiating uncovered iridium.
  • the wall 17 of the reservoir includes a plurality of notches 20, which appear as inwardly projecting bulges.
  • the notches 20 act to keep the iridium bar properly positioned within the reservoir, and help to avoid the risk of the iridium bar dropping out of the reservoir.
  • FIG. 3 shows another preferred embodiment of the present invention, after the irradiated capsule has been connected to the flexible cable.
  • a capsule 110 manufactured of titanium, originally including a bar of iridium, and having an open end 112 and a closed end
  • the capsule 110 includes a reservoir, now containing a single bar 130 of iridium-192, which acts as a radiation source.
  • the open end 112 of capsule 110 is hermetically sealed by means of a plug 140, equally made of titanium, which includes an elongated portion 142, for insertion into the open end 112 of capsule 110.
  • the plug 140 further includes an extended portion 144, connected to the main body of the plug through an indented break point 146.
  • the elongated portion 142 of plug 140 may be on approx. 0.1 mm in length, and still provide adequate sealing of the capsule 110.
  • the extended portion 144 of plug 140 may be used as a grip portion during pull testing in order to assure the strength and reliability of weld 120. Following a successful pull test, the extended portion 144 may be broken off from the main body of plug 140 at break point 146.
  • the device according to this embodiment is constructed in such a manner that the length of the rigid portion may be from 0.5 to 1 mm greater than the length needed to accommodate the bar 130 of iridium-192. In particular, the rigid portion of the device according to this embodiment is approx. 4.5 mm in length. If an iridium- 192 source, obtained by irradiating enriched iridium-191, is utilized, the length of the rigid portion of the device may be reduced even further.

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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)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

L'invention se rapporte à un dispositif pour introduire une source de rayonnement radioactif (14) dans le corps. Ce dispositif comprend un câble flexible (10) pouvant être introduit dans le corps, ainsi qu'une capsule de titane (12) servant à renfermer hermétiquement une source radioactive (14), cette capsule (12) présentant un réservoir tubulaire à paroi mince, raccordé coaxialement au câble (10).
PCT/US1994/004213 1993-04-13 1994-04-12 Dispositif pour introduire une source radioactive dans le corps WO1994023789A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU67062/94A AU6706294A (en) 1993-04-13 1994-04-12 Radioactive source introduction device
EP94914813A EP0695204A4 (fr) 1993-04-13 1994-04-12 Dispositif pour introduire une source radioactive dans le corps
JP6523503A JPH08509143A (ja) 1993-04-13 1994-04-12 放射能源導入装置

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP93201059.8 1993-04-13
EP93201059 1993-04-13

Publications (1)

Publication Number Publication Date
WO1994023789A1 true WO1994023789A1 (fr) 1994-10-27

Family

ID=8213757

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/004213 WO1994023789A1 (fr) 1993-04-13 1994-04-12 Dispositif pour introduire une source radioactive dans le corps

Country Status (6)

Country Link
EP (1) EP0695204A4 (fr)
JP (1) JPH08509143A (fr)
AU (1) AU6706294A (fr)
CA (1) CA2160460A1 (fr)
HU (1) HUT72942A (fr)
WO (1) WO1994023789A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997048452A1 (fr) * 1996-06-17 1997-12-24 The State Of Israel, Atomic Energy Commission Soreq Nuclear Research Center Catheter radioactif en rhenium
NL1003528C2 (nl) * 1996-07-05 1998-01-07 Optische Ind Oede Oude Delftoe Samenstel van een capsule voor brachytherapie en een leidraad.
US5782742A (en) * 1997-01-31 1998-07-21 Cardiovascular Dynamics, Inc. Radiation delivery balloon
US6048299A (en) * 1997-11-07 2000-04-11 Radiance Medical Systems, Inc. Radiation delivery catheter
US6149574A (en) * 1997-12-19 2000-11-21 Radiance Medical Systems, Inc. Dual catheter radiation delivery system
US6287249B1 (en) 1998-02-19 2001-09-11 Radiance Medical Systems, Inc. Thin film radiation source
US6458069B1 (en) 1998-02-19 2002-10-01 Endology, Inc. Multi layer radiation delivery balloon
US6491619B1 (en) 1997-01-31 2002-12-10 Endologix, Inc Radiation delivery catheters and dosimetry methods
US6505392B1 (en) * 1994-06-08 2003-01-14 Interventional Therapies Llc Process for manufacturing a radioactive source wire for irradiating diseased tissue
NL1032714C2 (nl) * 2006-10-20 2008-04-22 Isodose Control Intellectual P Transportkabel en broncapsule met veilige verbindingsconstructie voor het inwendig bestralen van patienten.

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4819618A (en) * 1986-08-18 1989-04-11 Liprie Sam F Iridium/platinum implant, method of encapsulation, and method of implantation
US4861520A (en) * 1988-10-28 1989-08-29 Eric van't Hooft Capsule for radioactive source
US4891165A (en) * 1988-07-28 1990-01-02 Best Industries, Inc. Device and method for encapsulating radioactive materials
WO1992000776A1 (fr) * 1990-07-13 1992-01-23 Mallinckrodt Medical, Inc. Dispositif d'introduction d'une source radioactive dans le corps
US5084002A (en) * 1988-08-04 1992-01-28 Omnitron International, Inc. Ultra-thin high dose iridium source for remote afterloader

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4323055A (en) * 1980-04-08 1982-04-06 Minnesota Mining And Manufacturing Company Radioactive iodine seed
US4702228A (en) * 1985-01-24 1987-10-27 Theragenics Corporation X-ray-emitting interstitial implants
US4827493A (en) * 1987-10-05 1989-05-02 Amersham Corporation Radiographic source

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4819618A (en) * 1986-08-18 1989-04-11 Liprie Sam F Iridium/platinum implant, method of encapsulation, and method of implantation
US4891165A (en) * 1988-07-28 1990-01-02 Best Industries, Inc. Device and method for encapsulating radioactive materials
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
WO1992000776A1 (fr) * 1990-07-13 1992-01-23 Mallinckrodt Medical, Inc. Dispositif d'introduction d'une source radioactive dans le corps

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0695204A4 *

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6876712B1 (en) 1994-06-08 2005-04-05 Interventional Therapies, L.L.C. Flexible source wire for localized internal irradiation of tissue
US6505392B1 (en) * 1994-06-08 2003-01-14 Interventional Therapies Llc Process for manufacturing a radioactive source wire for irradiating diseased tissue
WO1997048452A1 (fr) * 1996-06-17 1997-12-24 The State Of Israel, Atomic Energy Commission Soreq Nuclear Research Center Catheter radioactif en rhenium
NL1003528C2 (nl) * 1996-07-05 1998-01-07 Optische Ind Oede Oude Delftoe Samenstel van een capsule voor brachytherapie en een leidraad.
WO1998001184A1 (fr) * 1996-07-05 1998-01-15 Delft Instruments Intellectual Property B.V. Combinaison d'une capsule de curietherapie et d'un fil de guidage
US6196964B1 (en) 1996-07-05 2001-03-06 Delft Instruments Intellectual Property B.V. Combination of a capsule for brachytherapy and a guidewire
US6699170B1 (en) 1997-01-31 2004-03-02 Endologix, Inc. Radiation delivery balloon catheter
US5782742A (en) * 1997-01-31 1998-07-21 Cardiovascular Dynamics, Inc. Radiation delivery balloon
US6176821B1 (en) 1997-01-31 2001-01-23 Radiance Medical Systems, Inc. Radiation delivery balloon catheter
US6491619B1 (en) 1997-01-31 2002-12-10 Endologix, Inc Radiation delivery catheters and dosimetry methods
US6048299A (en) * 1997-11-07 2000-04-11 Radiance Medical Systems, Inc. Radiation delivery catheter
US6149574A (en) * 1997-12-19 2000-11-21 Radiance Medical Systems, Inc. Dual catheter radiation delivery system
US6287249B1 (en) 1998-02-19 2001-09-11 Radiance Medical Systems, Inc. Thin film radiation source
US6685618B2 (en) 1998-02-19 2004-02-03 Endologix, Inc. Method for delivering radiation to an intraluminal site in the body
US6458069B1 (en) 1998-02-19 2002-10-01 Endology, Inc. Multi layer radiation delivery balloon
NL1032714C2 (nl) * 2006-10-20 2008-04-22 Isodose Control Intellectual P Transportkabel en broncapsule met veilige verbindingsconstructie voor het inwendig bestralen van patienten.
EP1913973A1 (fr) * 2006-10-20 2008-04-23 Isodose Control Intellectual Property B.V. Câble de transport et capsule de source avec construction de connexion sécurisée pour patients à rayonnement interne
US10933255B2 (en) 2006-10-20 2021-03-02 Nucletron Operations B.V. Transport cable and source capsule with safe connecting construction for internally irradiating patients

Also Published As

Publication number Publication date
EP0695204A4 (fr) 1996-08-28
CA2160460A1 (fr) 1994-10-27
AU6706294A (en) 1994-11-08
EP0695204A1 (fr) 1996-02-07
HUT72942A (en) 1996-06-28
HU9502963D0 (en) 1995-12-28
JPH08509143A (ja) 1996-10-01

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