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WO2011138130A1 - Cathéter de positionnement pour irradiation intravasculaire de vaisseaux coronariens et périphériques avec des rayons radioactifs - Google Patents

Cathéter de positionnement pour irradiation intravasculaire de vaisseaux coronariens et périphériques avec des rayons radioactifs Download PDF

Info

Publication number
WO2011138130A1
WO2011138130A1 PCT/EP2011/055653 EP2011055653W WO2011138130A1 WO 2011138130 A1 WO2011138130 A1 WO 2011138130A1 EP 2011055653 W EP2011055653 W EP 2011055653W WO 2011138130 A1 WO2011138130 A1 WO 2011138130A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
positioning catheter
positioning
distal portion
application
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/EP2011/055653
Other languages
German (de)
English (en)
Inventor
Tuomo Nikula
Oliver Buck
Thomas Buchner
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.)
ITM Isotope Technologies Munich SE
Original Assignee
ITM Isotopen Technologien Muenchen AG
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 ITM Isotopen Technologien Muenchen AG filed Critical ITM Isotopen Technologien Muenchen AG
Publication of WO2011138130A1 publication Critical patent/WO2011138130A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61N2005/1003—Intraluminal radiation therapy having means for centering a radioactive source within the lumen, e.g. balloons

Definitions

  • the present invention relates to an apparatus for use in the intravascular irradiation of coronary and peripheral vessels, and more particularly to a radioactive radiator positioning catheter and a corresponding delivery system.
  • the object of the present invention is to provide a medical device with which the disadvantages of the prior art in the application of radioactive substances in blood vessels by means of catheters, and in particular a necrosis or irreparable damage to the vessel wall by a too high radiation dose reduced or avoided can be.
  • the object is achieved by a positioning catheter having the features of claim 1 and a corresponding application system having the features of claim 12.
  • the positioning catheter according to the invention serves to introduce and position an application catheter for a radioactive substance in a blood vessel of a patient.
  • the positioning catheter according to the invention comprises a distal portion which is adapted to receive a distal end of the application catheter.
  • the positioning catheter ter and in particular the distal portion thereof are constructed so that a distance between the inserted into the positioning catheter application catheter and the inner wall of the vessel is maintained.
  • the distance to the vessel inner wall is determined by the design and dimensions of the positioning catheter and can be determined in the design of the positioning catheter as a function of the radiation intensity of the radiation source.
  • the distal section of the positioning catheter is set up such that when the application catheter is inserted, blood flow between the distal section of the positioning catheter and the inner wall of the vessel is permitted.
  • an oxygen deficiency of tissue and an associated infarct pain can be avoided. It is thereby possible to carry out radioactive irradiation of tissue without regard to time constraints due to the risk of oxygen deficiency with the medically optimal duration.
  • the distal section of the positioning catheter comprises a plurality of spacers.
  • the spacers may be formed by filaments extending in a longitudinal direction of the positioning catheter disposed about the longitudinal axis of the distal portion of the positioning catheter.
  • the filaments form a crown of the positioning catheter.
  • a space is formed by the filaments between them, which space comprises the longitudinal axis of the distal section of the positioning catheter and is adapted to receive the application catheter.
  • the filament comprises a flat in a plane shaped wire or consists of such.
  • the filament according to another embodiment may also comprise or consist of a wire extending in two orthogonal directions.
  • the wire may, according to a In the case of the second embodiment, they have a periodically repeating structure. This structure may have, for example, meandering, wave-shaped, in particular sine-wave-shaped, triangular, sawtooth-shaped, rectangular-shaped sections or combinations thereof.
  • the height of the filament which is also determinative of the distance between the application catheter or radiation source inserted into the distal portion of the positioning catheter, can be 10 ⁇ m, 100 ⁇ m, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm or a value above or below it.
  • the filaments each extend radially to the longitudinal or longitudinal axis of the distal portion of the positioning catheter.
  • the cross section of the distal portion of the positioning catheter may be star-shaped.
  • the distal section comprises 2, 4 or 6 pairs of diametrically extending filaments.
  • the distal portion of the positioning catheter may also have a three-dimensionally shaped tubular structure, or may be constructed of a plurality of elements formed by portions of a tubular structure or cylinder, such as partially cylindrical members or filaments.
  • the blood flow between the inner wall of the vessel and the distal end of an application catheter inserted in the positioning catheter or an introduced radiation source is preferably allowed.
  • a distance between the vessel wall and a radiation source or an application catheter introduced into the positioning catheter can likewise be maintained.
  • the distal portion of the positioning catheter or filaments in particular the wire of the filaments, may be made of metal, a metal alloy such as a shape memory alloy such as Nitinol, or also of plastic.
  • Shape memory alloys have two crystal structures, between which a change in shape can occur due to temperature change. The shape memory alloys can remember two forms - one at high and one at low temperature. In order for the material to resume its defined shape on cooling, it can be trained by thermo-mechanical treatment cycles.
  • the distal portion of the positioning catheter comprises a compressed shape in which its radial diameter is reduced and an expanded shape in which its radial diameter is increased. In particular, this is made possible by the structure and the construction of the distal section of the positioning catheter or the filaments used therefor.
  • the structure of the distal. Portion of the positioning catheter is preferably constructed so that it folds up and unfolds.
  • the unfolding of the distal portion of the positioning catheter may be accomplished or assisted by a shape transformation of a shape memory alloy from which the distal portion of the positioning catheter is made or the filaments forming the distal portion are made.
  • the distal section can be prepared, for example, by thermo-mechanical treatment cycles so that it expands after being heated in the body above a critical temperature to a predetermined size or a pre-encoded diameter.
  • the distal sections of positioning catheters can thus be adapted and preset to different vessel diameters.
  • the positioning catheter comprises a sheath catheter in which the positioning catheter is arranged and into which the distal portion of the positioning catheter can be withdrawn.
  • the distal section is brought into the compressed form.
  • the distal portion of the positioning catheter may be advanced out of the positioning catheter, with the distal portion merging into the expanded shape.
  • the transition to the expanded shape may be accomplished by the shaping or material of the distal portion or, as described above, by the shape transformation property of a shape memory alloy used in the distal portion.
  • the sheath catheter is preferably in the form of a flexible tube or tube and may be made of the same material as the positioning catheter.
  • an application system with the features of claim 12 is further provided.
  • the application system comprises the positioning catheter according to the invention, an application catheter which can be inserted into the positioning catheter, and a sheath catheter in which the positioning catheter can be displaceably arranged.
  • the application system makes it possible to use a radioactive radiation source for the intravascular irradiation of vessels, whereby an increased distance between the radiation source and the vessel inner wall that is inserted into the positioning catheter is achieved so that damage due to excessive radiation density can be avoided.
  • the application catheter is a balloon catheter.
  • the distal portion of the positioning catheter or filaments may be made of metal, a metal alloy such as a shape memory alloy such as nitinol or plastic.
  • radioactive substances such as Re may be used.
  • FIG. 1 shows an exemplary embodiment of a positioning catheter with a
  • Fig. 2a, b show cross sections of the positioning catheter with four or eight filaments.
  • the positioning catheter 1 comprises at the proximal end an adapter 3 to which a flexible tube is connected in the distal direction.
  • the distal portion 5 of the positioning catheter 1 is formed by a crown comprising a plurality of filaments 7 extending in the longitudinal direction of the distal portion 5.
  • the filaments 7 form between them a space which comprises the longitudinal axis of the distal section 5 of the positioning catheter 1.
  • a distal portion of an application catheter 1 1 is added.
  • the distal portion of the delivery catheter 11 is formed by a balloon 13 which can be expanded with a liquid or gas.
  • the liquid or the gas may contain a radioactive substance for radiation treatment of a vessel such as Re 188 .
  • the filaments 7 are connected to each other.
  • the distal section 5 of the positioning catheter 1 according to the cross-sectional drawing shown in Fig. 2a comprises four filaments 7 and according to the cross section shown in Fig. 2b eight filaments 7, which are in pairs diametrically to the longitudinal axis of the distal portion 5 of the positioning catheter first extend.
  • the individual filaments 7 extend in a plane and have a periodic waveform.
  • the distal portion of the positioning catheter 1 and the filaments 7 are formed so that without a force on the filaments 7 between them a space is formed in which the distal end of an application catheter 11, such as the balloon 13 of an application catheter can be accommodated. This condition is shown in FIG.
  • a distance to an inner vessel wall (not shown) of a patient, which corresponds to the radial extent and the height of the filaments 7, is created between the distal end of the application catheter 11 introduced in the positioning catheter.
  • the blood can circulate between the vessel wall and the distal end of the application catheter 11, so that oxygen undersupply of tissue parts during a treatment can be avoided.
  • the positioning catheter 1 is arranged in a sheath catheter 15, which also has the form of a flexible tube or shaft.
  • a Y-adapter 17 is arranged at the proximal end of the tunneled catheter 15.
  • the proximal end of the positioning catheter 1 protrudes from the proximal end of the tunneled catheter 15.
  • the distal portion thereof can be retracted into the sheath catheter 15 so that the distal portion of the positioning catheter 1 is completely contained therein.
  • the sheath catheter 15 can also be pushed over the positioning catheter 1 to completely accommodate its distal portion in the sheath catheter 15.
  • the filaments 7 are compressed and folded together when the positioning catheter 1 is pulled into the tunneled catheter 15 so that overall the radial diameter of the distal section of the positioning catheter 1 on the inner diameter of the tunneled catheter 15 is reduced.
  • the structure of the distal portion of the positioning catheter 1 is formed so that the radial diameter of the distal portion of the positioning catheter 1 automatically expands upon being pushed out of the sheath catheter 15.
  • the automatic expansion is achieved by the shape conversion property of the shape memory alloy used for the distal portion.
  • Form conversion to the previously precoded extended position is achieved by the body temperature and body fluids surrounding the distal portion of the positioning catheter, particularly the blood that reaches the distal portion of the positioning catheter 1 after insertion into the body or blood vessels of a patient over that for shape transformation to warm the critical temperature.
  • the space created between the filaments is sufficient to receive the balloon 13 of the delivery catheter 11, which is filled for treatment with a radioactive substance.
  • the balloon 13 of the application catheter 11 is radially expanded until it comes into contact with the filaments 7.
  • the filaments 7 can also be pressed further outwards, so that the diameter of the distal section 5 is increased.
  • the balloon catheter By extending radially to the longitudinal axis of the distal portion of the positioning catheter 1 filaments 7, a distance between the application catheter 11 and its balloon 13 and the vessel inner wall is maintained.
  • the balloon catheter is centered by the filaments 7 in the vessel, so that all tissue parts surrounding the positioning catheter 1 have the same distance to the application catheter 11 and are subjected to the same radioactive radiation density.
  • the positioning catheter 1 arranged in the tunneled catheter 15 is brought via a guide wire to the vessel site to be treated, and then the sheath catheter 15 is withdrawn so that the distal section 5 of the positioning catheter 1 unfolds. Subsequently, the application catheter 11 is inserted into the positioning catheter 1 until its balloon 13 is arranged in the distal section 5 of the positioning catheter 1. Then, a liquid provided with a radioactive substance is introduced into the Ap ⁇ carriesskatheter 11 pumped so that it expands. The application catheter 1 1 remains inflated until the end of the treatment and is subsequently drained and removed from the positioning catheter 1.
  • the distal portion formed distal portion of the positioning catheter 1 can be provided.
  • the filaments 7 may be formed from the tubular material of the positioning catheter 1 at the distal portion thereof or may also be attached to the distal end of the positioning catheter 1.
  • spacers or filaments arranged annularly around the longitudinal direction of the distal section of the positioning catheter instead of filaments extending in the longitudinal direction of the positioning catheter, wherein the annular spacers or filaments are connected to one another by transversely extending spacers or filaments.
  • the distal portion could also be formed by a lattice or net shaped structure of spacers or filaments surrounding the longitudinal axis of the distal portion of the positioning catheter 1, the lattice or mesh having a regular, rectangular, square, diamond or polyhedral pattern.
  • the struts of the grid or net structure may be formed by spacers or filaments as described above.

Landscapes

  • 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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter de positionnement pour l'introduction et le positionnement d'un cathéter d'application dans un vaisseau d'un patient, le cathéter de positionnement comportant une section distale qui sert au logement d'une extrémité distale du cathéter d'application et qui comporte une structure qui produit une distance entre le cathéter d'application introduit dans le cathéter de positionnement et la paroi interne du vaisseau.
PCT/EP2011/055653 2010-05-05 2011-04-12 Cathéter de positionnement pour irradiation intravasculaire de vaisseaux coronariens et périphériques avec des rayons radioactifs Ceased WO2011138130A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102010019422.0 2010-05-05
DE201010019422 DE102010019422B4 (de) 2010-05-05 2010-05-05 Positionierungskatheter zur intravasalen Bestrahlung koronarer und peripherer Gefäße mit radioaktiven Strahlen

Publications (1)

Publication Number Publication Date
WO2011138130A1 true WO2011138130A1 (fr) 2011-11-10

Family

ID=44469369

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2011/055653 Ceased WO2011138130A1 (fr) 2010-05-05 2011-04-12 Cathéter de positionnement pour irradiation intravasculaire de vaisseaux coronariens et périphériques avec des rayons radioactifs

Country Status (2)

Country Link
DE (1) DE102010019422B4 (fr)
WO (1) WO2011138130A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL2009699C2 (en) * 2012-10-25 2014-04-29 Nucletron Operations Bv A modular applicator for brachytherapy.

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0813894A2 (fr) * 1993-07-01 1997-12-29 Schneider (Europe) Ag Appareils médicaux pour le traitement des vaisseaux sanguins à l'aide de radiation ionisante
US5851171A (en) * 1997-11-04 1998-12-22 Advanced Cardiovascular Systems, Inc. Catheter assembly for centering a radiation source within a body lumen
US5891091A (en) * 1993-07-15 1999-04-06 Teirstein; Paul S. Irradiation catheter and method of use
US6059812A (en) * 1997-03-21 2000-05-09 Schneider (Usa) Inc. Self-expanding medical device for centering radioactive treatment sources in body vessels
US6159139A (en) * 1998-02-17 2000-12-12 Advanced Cardiovascular Systems Inc. Radiation delivery catheter with a spring wire centering mechanism
US6213976B1 (en) * 1999-07-22 2001-04-10 Advanced Research And Technology Institute, Inc. Brachytherapy guide catheter
US20020165520A1 (en) * 2001-05-07 2002-11-07 Forman Michael R. Combination ionizing radiation and radiosensitizer delivery devices and methods for inhibiting hyperplasia
US20030078539A1 (en) * 2000-12-27 2003-04-24 Peterson Eric D. Perfusion catheter and membrane
US20030153845A1 (en) * 2002-02-11 2003-08-14 Jeremy Emken Centering brachytherapy catheter
US6607476B1 (en) * 1998-10-01 2003-08-19 University Of Iowa Research Foundation Brachytherapy positioning system

Family Cites Families (2)

* 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
US7662082B2 (en) * 2004-11-05 2010-02-16 Theragenics Corporation Expandable brachytherapy device

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0813894A2 (fr) * 1993-07-01 1997-12-29 Schneider (Europe) Ag Appareils médicaux pour le traitement des vaisseaux sanguins à l'aide de radiation ionisante
US5891091A (en) * 1993-07-15 1999-04-06 Teirstein; Paul S. Irradiation catheter and method of use
US6059812A (en) * 1997-03-21 2000-05-09 Schneider (Usa) Inc. Self-expanding medical device for centering radioactive treatment sources in body vessels
US5851171A (en) * 1997-11-04 1998-12-22 Advanced Cardiovascular Systems, Inc. Catheter assembly for centering a radiation source within a body lumen
US6159139A (en) * 1998-02-17 2000-12-12 Advanced Cardiovascular Systems Inc. Radiation delivery catheter with a spring wire centering mechanism
US6607476B1 (en) * 1998-10-01 2003-08-19 University Of Iowa Research Foundation Brachytherapy positioning system
US6213976B1 (en) * 1999-07-22 2001-04-10 Advanced Research And Technology Institute, Inc. Brachytherapy guide catheter
US20030078539A1 (en) * 2000-12-27 2003-04-24 Peterson Eric D. Perfusion catheter and membrane
US20020165520A1 (en) * 2001-05-07 2002-11-07 Forman Michael R. Combination ionizing radiation and radiosensitizer delivery devices and methods for inhibiting hyperplasia
US20030153845A1 (en) * 2002-02-11 2003-08-14 Jeremy Emken Centering brachytherapy catheter

Also Published As

Publication number Publication date
DE102010019422A1 (de) 2011-11-10
DE102010019422B4 (de) 2013-05-16

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