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WO1998046309A1 - Catheter a double ballonnets series et methode de prevention de la restenose - Google Patents

Catheter a double ballonnets series et methode de prevention de la restenose Download PDF

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Publication number
WO1998046309A1
WO1998046309A1 PCT/US1998/007078 US9807078W WO9846309A1 WO 1998046309 A1 WO1998046309 A1 WO 1998046309A1 US 9807078 W US9807078 W US 9807078W WO 9846309 A1 WO9846309 A1 WO 9846309A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
catheter
radiation
angioplasty
lumen
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/US1998/007078
Other languages
English (en)
Inventor
David W. Pipes
James J. Mazeika
Edward F. Smith, Iii
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.)
Mallinckrodt Inc
Original Assignee
Mallinckrodt 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 Inc filed Critical Mallinckrodt Inc
Publication of WO1998046309A1 publication Critical patent/WO1998046309A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1047—Balloon catheters with special features or adapted for special applications having centering means, e.g. balloons having an appropriate shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • 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
    • A61N2005/1004—Intraluminal radiation therapy having expandable radiation sources
    • 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
    • A61N2005/1021—Radioactive fluid

Definitions

  • This invention relates to a method of treating stenosis (blocked arteries) and preventing restenosis (re-blocking of the artery).
  • Percutaneous transluminal angioplasty is the general technique of dilatation of a blocked artery (both peripheral and coronary (PTCA) arteries) with mechanical means at the end of a catheter.
  • the use of a balloon catheter in PTA is well known.
  • the catheter is positioned with the balloon at the site of the blockage, typically with the assistance of a guide wire and a fluoroscope, and the balloon inflated at high pressure (e.g.: 6 to 20 atmospheres (0.6 to 2 MPa).
  • high pressure e.g.: 6 to 20 atmospheres (0.6 to 2 MPa).
  • Restenosis is believed to occur as a result of injury to the arterial wall during the PTA procedure.
  • One approach to restenosis is to repeat the PTA procedure.
  • Another approach is the use of a stent, which is a small, typically metal device that holds the artery open.
  • Stents are only partially effective in preventing restenosis.
  • An approach that appears to be quite promising is the use of radiation to prevent restenosis. In doses of 8 to 30 Gy, radiation has been shown to be relatively safe and effective in preventing restenosis. While the exact mechanism of action is not known, it is suspected that the radiation "stuns" the cells that cause restenosis, rendering them less able to re-block the artery.
  • Another approach is to position guide wire past the obstruction, slide a balloon catheter over the guide wire to the obstruction, inflate the balloon to perform the angioplasty, remove the guide wire, and replace it with a wire having a radioactive tip.
  • This approach suffers the disadvantages of difficulties centering the radiation source and problems associated with removing the guide wire, which may complicate response to a sudden collapse of the artery.
  • a technique that results in uniform irradiation is the use of a balloon catheter filled with a radioactive liquid. It is generally thought to be undesirable to use the same balloon catheter as used for the PTA procedure because that balloon has been subject to the stress of the PTA procedure and may be more likely to rupture. The consequence of a rupture would be the release of a radioactive liquid in the patient's blood stream. Thus, the approach deemed more desirable is to remove the PTA balloon catheter and to insert another balloon catheter for the radiation treatment. This, however, has the disadvantage of making the treatment time longer and involves another insertion of an object into the patient, increasing the risk of infection, etc.
  • US 5,199,939 teaches a general method of preventing restenosis by supplying a source of radiation at the end of a catheter to the affected vessel. Dake uses radioactive pellets at the end of a catheter having variable stiffness along its length.
  • US 5,195,962 (Martin; Vas-Cath Incorporated) describes a catheter with 3 non-concentric lumens, and a method of manufacturing such a catheter. The central lumen of the catheter can be used for a guide wire.
  • This reference discloses several other multi-lumen catheters.
  • US 5,207,648 (Gross; The Kendall Company) describes a catheter with 3 concentric lumens.
  • US 5,226,889 discloses a catheter having 2 balloons where the distal balloon is used to open an artery and the second, of larger diameter, is used to implant a stent.
  • US 5,314,409 (Sarosiek; UVA Patents Foundation) teaches an esophageal perfusion catheter having two balloons and multiple lumens. Some of the lumens communicate with ports between the balloons.
  • US 5,342,306 (Michael) is representative of several disclosures that show two balloons used to isolate a treatment area in an artery so that liquid can be introduced into the space between the balloons without being washed away by blood flow.
  • WO 96/17654 (Thornton; Omnitron International) teaches the use of a balloon catheter filled with a radioactive liquid.
  • Thornton uses multiple concentric balloons to guard against leakage, etc.
  • Thornton uses a main balloon and two additional balloons on either side of the main balloon to block the flow in the artery in case of rupture of the main balloon, thus preventing flow of radioactive liquid throughout the patient's body.
  • the invention comprises an angioplasty catheter having two balloons spaced longitudinally apart (double serial balloon catheter).
  • the catheter is intended to allow both angioplasty and radiation treatment to be conducted with the single insertion of a single catheter.
  • the invention also comprises a method of sequentially performing coronary angioplasty and radiation of the angioplasty site with the single insertion of a double serial balloon catheter.
  • the apparatus and method allow for the quick and convenient angioplasty and radiation treatment of stenosed arteries without the drawbacks associated with the insertion and withdrawal two separate catheters.
  • FIG. 1 is a perspective view of a catheter according to the invention.
  • Fig. 2 is a cross section of a catheter according to the invention.
  • Fig. 3 is a cross section of an alternative embodiment of the catheter of the invention.
  • Fig. 4 is a cross section of yet another alternative embodiment of the catheter of the invention.
  • the invention involves the use of a catheter having two longitudinally spaced balloons to open and radioactively treat an artery.
  • FIG. 1 A catheter, according to the invention is shown in Fig. 1.
  • Catheter 10 has a main shaft 12, a proximal end 14, and a distal end 16.
  • main shaft 12 has an optional central lumen 20 intended to receive a guide wire.
  • Central lumen 20 may run the entire length of catheter 10 (shown in
  • Main shaft 12 may extend only from the distal end to a portion somewhat midway along main shaft 12 (so-called monorail configuration).
  • Main shaft 12 also has an angioplasty lumen 22 and a radiation lumen 24.
  • Fig. 3 shows a cross-section of an alternative construction of the catheter shaft in which main shaft 312 is made from 3 concentric tubes 321, 323, and 325, thus defining central lumen 320, angioplasty lumen 322, and radiation lumen 324.
  • main shaft 312 is made from 3 concentric tubes 321, 323, and 325, thus defining central lumen 320, angioplasty lumen 322, and radiation lumen 324.
  • the function assigned to the three lumens may be changed so that, for instance, the central lumen may function as the radiation lumen.
  • Fig. 4 shows a cross-section of an alternative construction of the catheter shaft in which main shaft 412 is made from 3 attached tubes 421, 423, and 425, thus defining guide wire lumen 420, angioplasty lumen 422, and radiation lumen 424.
  • main shaft 12 has at its distal end angioplasty balloon 32 and radiation balloon 34, and at its proximal end, connector block 46.
  • Angioplasty balloon 32 and radiation balloon 34 are spaced apart longitudinally along main shaft 12, with angioplasty balloon 32 more distal than radiation balloon 34.
  • radiation balloon 34 could be more distal than angioplasty balloon 32, this would mean that radiation balloon 34 would have to pass through the stenosed area before it had been opened by angioplasty balloon 32, risking damage to radiation balloon 34 that could result in a leak or radioactive material into the bloodstream of the patient.
  • angioplasty balloon 32 be more distal than radiation balloon 34.
  • Connector block 46 has a wire port 40 which connects to central lumen 20 and is adapted to allow a guide wire to pass through catheter 10.
  • Connector block 46 also has an angioplasty port 42 and a radiation port 44.
  • Angioplasty lumen 22 fluidly connects angioplasty port 42 to angioplasty balloon 32.
  • radiation lumen 24 fluidly connects radiation port 44 to radiation balloon 34.
  • Catheter 10 and its parts may be constructed of conventional materials by conventional processes well known to those skilled in the art, including by the use of the materials and processes described in the patents listed above, the disclosures of which are hereby incorporated by reference.
  • the method of the invention begins with the insertion of the above- described catheter 12 into a stenosed (blocked) artery of a mammalian patient, preferably a human patient.
  • Catheter 12 is preferably (but optionally) advanced over a previously positioned guide wire (not illustrated) which passes through central lumen 20 and out through wire port 40.
  • catheter 10 is advanced to the point that angioplasty balloon 32 is centered in the stenosed area of the artery, fluid pressure is applied through angioplasty port 42, through angioplasty lumen 22, to inflate angioplasty balloon 32.
  • the inflation procedure is conventional and the fluid pressure may be provided, for instance, by depressing the plunger of a syringe filled with a liquid such as saline or an X-ray contrast agent.
  • a liquid such as saline or an X-ray contrast agent.
  • an X-ray contrast agent to provide the fluid pressure is preferred because its use, in connection with a fluoroscope, will aid in determining whether the stenosis has been fully dilated.
  • angioplasty balloon 32 is deflated by withdrawing the fluid through angioplasty lumen 22 and angioplasty port 42.
  • Catheter 10 is then advanced through the artery until radiation balloon 34 is at the site of the corrected stenosis.
  • radiation balloon 34 is in place, it is inflated with a radioactive fluid through radiation port 44 and radiation lumen 24.
  • a radioactive fluid typically 0.6 to 2 MPa
  • the radiation portion of the procedure requires only enough pressure to fully inflate radiation balloon (typically 0.1 to 0.4 MPa).
  • the fluid pressure may be provided, for example, by depressing a syringe.
  • the radioactive fluid is preferably a liquid (e.g., a solution) that emits primarily medium to high strength beta radiation (e.g., 0.6 to 2.3 MeV (6.4 x 10 12 to 24.4 x 10 12 J), such as a solution containing Sm-153, Re-186, P-32, Re-188, or Y-90.
  • medium to high strength beta radiation e.g., 0.6 to 2.3 MeV (6.4 x 10 12 to 24.4 x 10 12 J)
  • a solution containing Sm-153, Re-186, P-32, Re-188, or Y-90 a solution containing Sm-153, Re-186, P-32, Re-188, or Y-90.
  • therapeutic dose of radiation is meant sufficient radiation to reduce the incidence or severity of restenosis, but not so much as to cause substantial necrosis of the artery or surrounding organs.
  • radioactive fluid that is sufficiently radioactive that a therapeutic dose can be delivered in a relatively short period of time, for instance, less than 3 minutes.
  • radiation balloon 34 can be inflated with a radioactive fluid for several minutes, deflated for a time to allow blood flow to resume, and thereafter reinflated to complete the dose. For very weak radioactive fluids this cycle may have to be repeated several times.
  • a bypass lumen (not illustrated) that will allow blood to flow from one side of an inflated balloon to the other through catheter 12. The use of bypass lumens is well known in the art.
  • EXAMPLE 1 (Hypothetical Example) A catheter generally resembling a Mallinckrodt® Vantage® peripheral dilation catheter is prepared; the notable difference being that the specially- prepared catheter has, in addition to the guide wire lumen and single balloon and its associated lumen, an additional balloon and associated lumen. An incision is prepared in the femoral artery of a human patient and with the assistance of a fluoroscope, a guide wire is positioned past a stenosed site in the femoral artery.
  • the specially-prepared catheter is fed onto the guide wire and advanced into the femoral artery of the patient.
  • the catheter is advanced further until the most distal balloon is at the site of the stenosis.
  • Diluted Hexabrix® X-ray contrast media (from Mallinckrodt Medical, Inc.) is forced out of the inflator syringe by hand to inflate the balloon to 1.5 MPa, opening the artery.
  • the balloon is then deflated to allow the catheter to be repositioned.
  • the catheter is then advanced further until the second balloon is at the site of the former stenosis.
  • the second balloon having a volume of 0.25 ml, remains inflated and in position for 5 minutes, delivering a dose of 15 Gy (at 0.5 mm depth) to the artery.
  • the second balloon is deflated by withdrawing the plunger of the syringe.
  • the catheter is then withdrawn from the patient, followed by withdraw of the guide wire.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

On décrit un cathéter pour angioplastie qui comprend deux ballonnets disposés longitudinalement à distance l'un de l'autre (cathéter à double ballonnets séries). Ce cathéter est conçu pour être utilisé dans un traitement angioplastique ou une radiothérapie devant s'effectuer avec une seule insertion d'un seul cathéter. On décrit également une méthode qui permet de réaliser séquentiellement une angioplastie coronaire et une radiation du site angioplastique en procédant à une seule insertion d'un cathéter à double ballonnets séries. L'appareil et la méthode fournissent un moyen rapide et pratique d'effectuer un traitement angioplastique ou une radiothérapie d'artères sténosées, sans les inconvénients liés à l'insertion et au retrait de deux cathéters séparés.
PCT/US1998/007078 1997-04-17 1998-04-10 Catheter a double ballonnets series et methode de prevention de la restenose Ceased WO1998046309A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US4392697P 1997-04-17 1997-04-17
US60/043,926 1997-04-17

Publications (1)

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WO1998046309A1 true WO1998046309A1 (fr) 1998-10-22

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1048325A2 (fr) 1999-04-30 2000-11-02 Mallinckrodt Inc. Dispositif d'admission pour la manipulation de liquide radioactif
US8603064B2 (en) 2008-09-22 2013-12-10 Covidien Lp Double balloon catheter and methods for homogeneous drug delivery using the same
WO2017004019A1 (fr) * 2015-06-30 2017-01-05 Cosette, Lee & Harrison, LLC Cathéter endovasculaire avec capacités multiples

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5195962A (en) 1987-12-22 1993-03-23 Vas-Cath Incorporated Triple lumen catheter
US5199939A (en) 1990-02-23 1993-04-06 Dake Michael D Radioactive catheter
US5207648A (en) 1990-12-14 1993-05-04 The Kendall Company Multilumen catheter
US5226889A (en) 1990-07-30 1993-07-13 Imad Sheiban Double balloon catheter for stent implantation
US5314409A (en) 1993-03-11 1994-05-24 Uva Patents Foundation Catheter for esophageal perfusion
US5342306A (en) 1993-05-26 1994-08-30 Don Michael T Anthony Adjustable catheter device
EP0688580A1 (fr) * 1994-06-24 1995-12-27 Schneider (Europe) Ag Appareil médical pour le traitement d'une portion de vaisseau corporel par radiation ionisante
WO1996017654A1 (fr) 1994-12-08 1996-06-13 Omnitron International, Inc. Radiotherapie intravasculaire utilisant une source en suspension dans un liquide
US5556389A (en) * 1994-03-31 1996-09-17 Liprie; Samuel F. Method and apparatus for treating stenosis or other constriction in a bodily conduit
WO1997018012A1 (fr) * 1995-11-13 1997-05-22 Localmed, Inc. Dispositifs et procedes permettant d'irradier et de traiter un organe corporel interne

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5195962A (en) 1987-12-22 1993-03-23 Vas-Cath Incorporated Triple lumen catheter
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
US5226889A (en) 1990-07-30 1993-07-13 Imad Sheiban Double balloon catheter for stent implantation
US5207648A (en) 1990-12-14 1993-05-04 The Kendall Company Multilumen catheter
US5314409A (en) 1993-03-11 1994-05-24 Uva Patents Foundation Catheter for esophageal perfusion
US5342306A (en) 1993-05-26 1994-08-30 Don Michael T Anthony Adjustable catheter device
US5556389A (en) * 1994-03-31 1996-09-17 Liprie; Samuel F. Method and apparatus for treating stenosis or other constriction in a bodily conduit
EP0688580A1 (fr) * 1994-06-24 1995-12-27 Schneider (Europe) Ag Appareil médical pour le traitement d'une portion de vaisseau corporel par radiation ionisante
WO1996017654A1 (fr) 1994-12-08 1996-06-13 Omnitron International, Inc. Radiotherapie intravasculaire utilisant une source en suspension dans un liquide
WO1997018012A1 (fr) * 1995-11-13 1997-05-22 Localmed, Inc. Dispositifs et procedes permettant d'irradier et de traiter un organe corporel interne

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1048325A2 (fr) 1999-04-30 2000-11-02 Mallinckrodt Inc. Dispositif d'admission pour la manipulation de liquide radioactif
US8603064B2 (en) 2008-09-22 2013-12-10 Covidien Lp Double balloon catheter and methods for homogeneous drug delivery using the same
WO2017004019A1 (fr) * 2015-06-30 2017-01-05 Cosette, Lee & Harrison, LLC Cathéter endovasculaire avec capacités multiples
US10517603B2 (en) 2015-06-30 2019-12-31 Cosette, Lee & Harrison, LLC Endovascular catheter with multiple capabilities

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