WO1999040971A1 - Catheter d'application de rayonnement avec capacite d'irrigation de sang - Google Patents

Catheter d'application de rayonnement avec capacite d'irrigation de sang Download PDF

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Publication number
WO1999040971A1
WO1999040971A1 PCT/US1999/003327 US9903327W WO9940971A1 WO 1999040971 A1 WO1999040971 A1 WO 1999040971A1 US 9903327 W US9903327 W US 9903327W WO 9940971 A1 WO9940971 A1 WO 9940971A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
lumen
radiation source
guide wire
elongated
Prior art date
Application number
PCT/US1999/003327
Other languages
English (en)
Inventor
Christopher C. Andrews
Jeong S. Lee
Paul V. Neale
Ping Ye
Original Assignee
Advanced Cardiovascular Systems, 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 Advanced Cardiovascular Systems, Inc. filed Critical Advanced Cardiovascular Systems, Inc.
Priority to JP2000531222A priority Critical patent/JP2002502677A/ja
Priority to EP99932478A priority patent/EP1056518A1/fr
Publication of WO1999040971A1 publication Critical patent/WO1999040971A1/fr

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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
    • A61N5/1002—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
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1095—Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
    • 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

  • This invention generally relates to intravascular catheters and particularly to an intravascular catheter assembly for delivering radiation treatment to a body lumen while providing blood perfusion through the body lumen past and around the catheter.
  • PTCA percutaneous transluminal coronary angioplasty
  • a guiding catheter having a preshaped distal tip is percutaneously introduced into the cardiovascular system of a patient through the brachial or femoral artery and is advanced therein until the preshaped distal tip is disposed within the aorta adjacent to the ostium of the desired coronary artery.
  • the guiding catheter is then twisted and torqued from its proximal end to turn its distal tip so that it can be guided into the coronary ostium.
  • a guide wire and a dilatation catheter having an inflatable balloon on the distal end thereof are introduced into, and advanced through, the proximal end of the guiding catheter to the distal tip of the guiding catheter seated within the coronary ostium.
  • the distal tip of the guide wire is usually manually shaped (i.e. curved) by the physician or one of the attendants before it and the dilatation catheter are introduced into the guiding catheter.
  • the guide wire is usually first advanced out of the distal end of the guiding catheter and is maneuvered into the patient's coronary vasculature containing the stenosis to be dilated, and is then advanced beyond the stenosis.
  • the dilatation catheter is advanced over the guide wire until the dilatation balloon is positioned across the stenosis.
  • the balloon of the catheter is filled with radiopaque liquid at relatively high pressures (e.g., generally about 4-12 atmospheres) to inflate it to a predetermined size (preferably the same as the inner diameter of the artery at that particular location) in order to radially compress the atherosclerotic plaque of the stenosis against the inside of the wall of the artery, thereby increasing the diameter of the occluded artery.
  • the balloon can then be deflated so that the catheter can be removed and blood flow resumed through the dilated artery.
  • More recent devices and procedures for preventing restenosis after arterial intervention employ the use of a radiation source to reduce the proliferation of smooth muscle cells which are believed to be the primary cause of restenosis.
  • Balloon catheters have been used to deliver and maintain the radiation source in the area where arterial intervention has taken place, exposing the area to a sufficient radiation dose to inhibit cell growth.
  • Two devices and methods are described in International Publication No. WO 93/04735 (Hess) and WO 95/19807 (Weinberger).
  • Other devices and methods which utilize radiation treatment delivered by an intravascular catheter are disclosed in commonly-owned and assigned co- pending application U.S. Serial No. 08/654,698, filed May 29, 1996, entitled Radiation- Emitting Flow-Through Temporary Stent and co-pending application Serial No.
  • an intravascular catheter assembly which allows delivery of a radiation source to the area where restenosis may occur for a period of time sufficient to selectively destroy the cells and prevent development of restenosis while allowing blood to perfuse pass the occluded region during the radiation procedure.
  • Such an intravascular catheter would have to be relatively easy and inexpensive to manufacture, have an expandable region that is strong and reliable under pressure, and capable of being formed in a variety of shapes to allow flexibility in the amount and pattern of expansion and deformation of the expandable region.
  • the present invention satisfies these and other needs as will be described hereinafter.
  • the present invention is directed to an intravascular catheter with an expandable region located at the distal end of the catheter body which can hold open a body lumen for a sufficient period of time to permit delivery of a radiation source to the body lumen while permitting perfusion of blood through the vessel.
  • the intravascular catheter in accordance with the present invention includes an elongated catheter body having proximal and distal ends, a guide wire lumen extending at least partly through the elongated catheter body and an inflatable region located near the distal end of the elongated catheter body which include communication with an inflation lumen which extends from the proximal end of the catheter body.
  • the inflation region is configured to be flexible so that it can be expanded on a curved portion of a body lumen, such as a coronary artery. It is also configured to center a radiation source wire within the body lumen, even if the inflatable region is positioned on a curved section of the body lumen.
  • the inflation region performs all of these features while -4- still allowing blood to flow past it to supply oxygenated blood to tissue downstream from the catheter when the inflated region is in its expanded position.
  • the intravascular catheter of the present invention allows for an over-the-wire delivery for the advancement thereof of the elongated catheter body to a location within a body lumen where the radiation dose is to be administered.
  • the guide wire lumen is used both for advancing the elongated catheter body to the target area and for advancing a radiation source wire to target area as well.
  • the guide wire is removed from the guide wire lumen to allow the radiation source wire to be advanced to the target area.
  • the exchange may be done by first placing a protective sheath into the guide wire lumen by utilizing a support mandrel which advances the sheath into its proper position within the guide wire lumen.
  • the support mandrel can be removed to allow the radiation source wire to be advanced from the radiation source storage facility where it could be advanced through the protective sheath to the targeted area.
  • the inflatable region can be deflated to its original unexpanded state and the catheter and radiation source wire can then be removed from the patient's vasculature.
  • the inflatable region is made from the plurality of discrete segmented balloon elements which are deposed along the distal end of the elongated catheter body.
  • Each individual balloon segment has a pair of side walls opposite each other which produced a very low profile balloon segment which has a relatively small contact region which contacts the wall of the artery upon inflation.
  • Each individual balloon segment is oriented approximately 90 degrees from each adjacent balloon segment to increase the area between the walls of the balloon segments to create an expanded passage through which blood passes through when the balloon segments are inflated.
  • the inflatable region is made from a plurality of individual nodular elements which protrude from the surface of the elongated catheter body when inflated. These nodular elements, when expanded, have sufficient contact area to maintain the catheter in the target area in the artery and also allow for the centering of the radiation source wire within the artery.
  • nodular elements Since these plurality of nodular elements are spaced apart from one another, they provide a sufficient passageway for blood to flow past each individual nodular element, even when expanded, to allow blood perfusion past the catheter during the radiation treatment.
  • These nodular elements can be made from elastic (distensible) materials which allows the catheter to maintain a extremely thin profile when the nodular elements are in their unexpanded condition but will sufficiently inflate once in their expanded position to maintain and hold the catheter in the target area. As described below, there are several ways in which to form these expandable nodular elements on the elongated catheter body to achieve a successful intravascular catheter with blood perfusion capabilities.
  • FIGURE 1 is a perspective view depicting the inflatable region of an intravascular catheter embodying features of the present invention.
  • FIG. 2 is a cross-sectional end view of the catheter of FIG. 1 depicting the inflatable region in its expanded condition within an artery.
  • FIG. 3 is a cross-sectional view of the inflatable region of the catheter of FIG. 1, in which the inflatable region is expanded within a curved section of artery, thereby centering the radiation source wire within the artery.
  • FIG. 4 is a perspective view of one embodiment of an inflatable region of an intravascular catheter embodying features of the present invention.
  • FIG. 5 is a cross-sectional view of the inflatable region of FIG. 4, in its unexpanded condition.
  • FIG. 6 is a cross-sectional view of the inflatable region of FIG. 4, in its expanded condition.
  • FIG. 7 is a cross-sectional view of the inflatable region of FIG. 4, in which the inflatable region is expanded within a curved section of artery, thereby centering the radiation source wire within the artery.
  • FIG. 7A is a cross-sectional view of the inflatable region of FIG.4, taken along lines 7 A-7 A, showing the inflatable region fully expanded within the artery, thereby centering the radiation source wire.
  • FIG. 8 is a perspective view of another embodiment of an inflatable region of an intravascular catheter embodying features of the present invention.
  • FIG. 9 is a cross-sectional view of the inflatable region of FIG. 8, in its unexpanded condition.
  • FIG. 10 is a cross-sectional view of the inflatable region of FIG. 8, in its expanded condition.
  • FIG. 11 is a cross-sectional view of the inflatable region of FIG. 8, showing the inflatable region in its expanded condition within a curve section of artery, thereby centering the radiation source wire within the artery.
  • -7- FIG. 11 A is a cross-sectional view of the inflatable region of FIG. 11, taken along lines 11 A-l 1 A, showing the inflatable region as it is expanded within a curved section of artery, thereby centering the radiation source wire within the artery.
  • the present invention provides an intravascular catheter for delivery and maintaining a low dose radiation source to a patient's body lumen, such as a coronary artery or other vessel, for an extended period of time.
  • the catheter permits perfusion of blood during the radiation therapy and will center the radiation source so that equal amounts of radiation will be applied to the artery. While the invention is described in detail as applied to the coronary arteries, those skilled in the art will appreciate that it can also be used in other body lumens as well, such as peripheral arteries and veins. Where different embodiments have like elements, like reference numbers have been used.
  • FIGS. 1-3 illustrate an intravascular catheter assembly 10 embodying features of the present invention.
  • Catheter assembly 10 generally includes an elongated catheter body 11 with an inflatable region 12 on the distal portion thereof and an adapter 13 on a proximal end thereof.
  • An inner tubular member 14 extends coaxially with an outer tubular member 15 and defines an annular inflation lumen 16 which extends from the proximal end of the elongated catheter body 11 to the inflatable region 12 and connects in fluid communication the interior of the inflatable region 12 with a source of inflation fluid at the proximal end of the catheter assembly 10.
  • the distal end of the inner and outer tubular members 14 and 15 are joined together by suitable means such as adhesive or heat bonding to seal the inflation lumen 16.
  • the elongated catheter body 11 includes a guide wire lumen 17 positioned in the distal portion of the elongated catheter body which extends from the proximal to distal end of the elongated catheter body 11.
  • a guide wire (not shown) would be slidably disposed within the guide wire lumen 17 to facilitate the advancement and replacement of the catheter 10 within the artery 18.
  • the inflatable region 12 is made up of a plurality of discrete balloon elements 19 which are attached to the elongated catheter body 11 -8- and are in fluid communication with the inflation lumen 16 in order to inflate and deflate the balloon elements simultaneously.
  • FIG. 2 shows a cross-sectional view of the discrete balloon elements 19 in an inflated condition positioned within the artery 18.
  • each balloon element contacts the wall 20 of the artery only along a contact surface 21 of the balloon element.
  • a passageway 22 is created between the wall of the artery and the side walls 23 and 24 of each balloon element to create a fluid conduit which allows blood to flow past each balloon element upon inflation.
  • the radiation source wire 25 which is advanced within the guide wire lumen 17 remains centered within the artery 18.
  • each individual discrete balloon element 19 is oriented approximately 90 degrees from each adjacent inflation element to provide a sufficient passageway 22 which allows blood perfusion during the radiation treatment. It should be appreciated that each balloon element 19 can be oriented from each other at different angulations to perform substantially the same function of creating a sufficient flow passage to permit blood perfusion during the radiation treatment. In the embodiment shown in FIG. 1 , five individual balloon elements are shown; however, it should be appreciated that more or less balloon elements could be utilized in accordance with the present invention. Additionally, while each individual balloon element is shown directly contacting one another, it is also possible to place segments of non-inflatable segments between each balloon element to achieve a similar passageway for blood perfusion past the inflatable region 12.
  • Each balloon element 19 has a low profile configuration to form a sufficiently large passageway to allow blood to perfuse when the balloon elements are in the expanded condition.
  • the side walls 23 and 24 of each balloon segment are shaped in substantially square configurations to achieve proper centering of the radiation source wire within the artery. It should be appreciated that the side walls 23 and 24 can also be configured in other shapes, for example rectangularly, to provide proper centering of the radiation source wire within the artery.
  • the low profile of each balloon element creates -9- a contact surface 21 which is sufficiently large to make contact with the wall of the artery upon expansion to center and maintain the catheter within the artery, but is still small enough to create a sufficiently large passageway for blood perfusion.
  • the length and width of these contact surfaces may be varied as well.
  • the profile i.e., the distance between the two side walls
  • the profile should be sufficiently large enough to support and maintain the catheter within the artery upon expansion, but small enough to create a sufficient passage for blood flow. Since each individual balloon element is staggered 90 degrees from each other, a sufficiently large passageway should be formed.
  • the guide wire (not shown) can be removed from the guide wire lumen 17 and a radiation source wire 25 can be inserted into the guide wire lumen
  • the radiation source wire 25 is hollow at its distal end and contains a radiation dose in the form of a radiation source 26, such as pellets, radiation gas, or radioactive liquid or paste.
  • the radiation source wire 25 may have a radioactive source coated on its distal end. This radiation source wire 25 provides the proper doses of radiation to the areas of the artery
  • the guide wire can be removed from the guide wire lumen 17 to allow the protective sheath 27 to be loaded into the guide wire lumen utilizing a support mandrel (not shown).
  • a support mandrel (not shown).
  • the support mandrel can be removed from the proximal end of the catheter assembly.
  • the radiation source wire 25 can then be advanced through the protective sheath 27 by the afterloader to the target area where the radiation therapy is to be provided.
  • reference herein to the "target area” means that part of the body lumen that has received a PTCA, atherectomy, or similar procedure to reduce or remove a stenosis, which is subject to the development of restenosis caused, in part, by intimal hyperplasia or the proliferation of smooth muscle cells.
  • the inflatable region 12 can be deflated, allowing the entire catheter assembly and radiation source wire 25 to be removed from the body lumen.
  • the proximal end of the protective sheath 27 can be connected to an afterloader where the radiation source wire may be stored during the initial set up procedure when the catheter assembly is positioned in the target area. Thereafter, the radiation source wire can be advanced from the afterloader through the protective sheath to the target area, preventing or reducing possible exposure of the radiation source to personnel performing the radiation procedure.
  • the intravascular catheter utilizes an inflatable region 12 which is made up of a plurality of nodular elements 28, which when expanded, extend outwardly from the surface of the catheter body 11 to contact the wall 20 of the artery 18 during the radiation procedure.
  • nodular elements 28 are shown as they contact the wall 20 of the artery upon inflation. Since the nodular elements are spread apart from one another and have a minimum contact area with the wall of the artery, passageway 22 is created to allow blood flow past the nodular elements when they are expanded.
  • These individual nodular elements 28 provide an inflatable region 12 which maintains the catheter in the target area and centers the guide wire lumen 17, which in turn allows the radiation source wire 25 to be centered within the artery during radiation treatment.
  • the elongated catheter body 11 includes a pair of inflation lumens 29 and 30 to inflate rows 31 and 32 of nodular elements 28, which are formed opposite to each other on the elongated catheter body 11.
  • Each inflation lumen 29 and 30 has a plurality of openings 33 which extend through the outer surface 34 of the catheter body into the respective inflation lumens.
  • a thin layer of elastic material 35 is disposed over the outer surface 34 of the elongated catheter body 11 to -11- "encapsulate" the distal end of the catheter.
  • An outer sleeve 36 made from an in elastic material is placed over the thin layer of elastic material 35 at the distal end.
  • This outer sleeve 36 has a plurality of openings 37 cut therein which are placed over the openings 33 formed on the elongated catheter body 11.
  • the fluid causes the thin layer of elastic material 35 to expanded through the openings 37 in the outer sleeve 36, forming the individual nodular elements 28.
  • the size of each nodular elements increases accordingly until the nodular elements contact the wall of the artery to maintain and center the catheter in place.
  • the inflation fluid is purged from the inflation lumens, causing the thin layer of elastic material 35 to revert back to its initial unexpanded shape as shown in FIG. 5.
  • an intravascular catheter utilizing an inflation region 12 would be positioned into the target area of the artery 18 by sliding the catheter assembly over a guide wire which is already positioned in the target area.
  • the inflation region 12 can then be inflated to cause the nodular elements to extend outward from the surface of the elongated catheter body to contact and press against the wall of the artery.
  • the guide wire can then be removed from the guide wire lumen 14 to allow the protective sheath 25 to be loaded into the guide wire lumen utilizing a support mandrel. Once the protective sheath 27 is in place, the support mandrel can be removed to allow the radiation source wire 25 to be advanced to the targeted area within the artery.
  • the nodular elements can be deflated accordingly and the catheter, radiation source wire and protective sheath can then be removed from the patient's vasculature.
  • the catheter in another embodiment of the present invention, as shown in FIGS. 8-11 A, the catheter includes an inflatable region 12 made from a plurality of nodular elements 38 which extend from the outer surface 39 of the elongated catheter body 11.
  • these nodular elements 38 are designed to be inflated within the target area of the artery to maintain the catheter in place and to center the radiation source wire during the procedure.
  • each nodular element 38 is individually formed in an outer tubular member 40 which -12- comprises part of the elongated catheter body 11.
  • An inner tubular member 41 which extends the length of the catheter assembly includes a guide wire lumen 17 formed therein.
  • the inflation lumen 16 is formed in the space between the outer tubular member 40 and inner tubular member 41.
  • these nodular balloon elements 38 are arranged in rows 42 and 43 along the outer tubular member 40.
  • FIG. 9 shows the nodular elements 38 as they would remain in the unexpanded position on the catheter.
  • the material making up each nodular element is folded along the outer surface 39 of the outer tubular member 40. In this manner, the overall catheter profile is reduced to allow the catheter to more easily navigate within the vasculature of the patient.
  • inflation within the inflation lumen 16 causes the nodular elements 38 to extend outwardly to form the expanded shape depicted in FIG. 8.
  • the nodular balloon elements 38 are designed to extend outwardly to contact a portion of the wall 20 of the artery 18 to maintain the catheter in place and to center the guide wire lumen allowing the radiation source wire 25 to be centered within the artery during the procedure.
  • the particular structure and use of the nodular elements 38 also creates a passageway 22 between the catheter and wall of the artery to permit blood flow during the radiation treatment.
  • the catheter can remain in the patient's vasculature for an extended period without the fear of possible tissue damage due to a lack of oxygenated blood to the tissue distal to the catheter.
  • FIGS. 4 and 6 show a particular arrangement of the nodular balloon elements in a pair of rows which are disposed approximately 180 degrees from each other on the elongated balloon catheter, it is possible to stagger the spacing and orientation of the individual nodular balloon elements along the elongated catheter body to create an inflation region which is capable of centering the radiation source wire and will provide an adequate passageway for blood to flow.
  • These nodular elements need not be arranged in just two rows, but rather can be arranged in more rows if desired.
  • the nodular balloon elements need not be arranged in rows at all, but rather, can be strategically placed around the elongated catheter body as needed provided that the arrangement of nodular balloon elements cooperate to center the radiation source wire and -13- create a sufficiently large passageway for blood perfusion.
  • the particular size and shape of the nodular balloon elements can be varied to take on different shapes and sizes without departing from the spirit and scope of the present invention. In such a case, the shape and size of the nodular balloon element in the embodiment shown in FIG. 4 can be easily varied by changing the shape and/or size of the openings 37 which extend in the outer sleeve 36 of the catheter.
  • each nodular balloon element formed on the inflatable region of FIG. 8 could likewise be modified to different sizes and shapes to embody the features of the present invention.
  • the dimensions of the catheter assembly of the present invention are essentially the same dimensions of catheters used in angioplasty procedures.
  • the overall length of the catheter may be about 100 to 175 cm, and preferably about 135 cm when a Seldinger approach through the femoral artery is employed.
  • the diameter of the catheter body may range from about .030 to 0.100 inch.
  • the inflatable region in its unexpanded condition has approximately the same diameter as the catheter body, but may be expanded to a maximum diameter of about one to about 5 mm for coronary arteries and substantially larger (e.g., 10 mm) for peripheral arteries.
  • the diameter of the guide wire lumen should be sufficiently larger than the diameter of the guide wire and through the guide wire to allow the catheter to be easily advanced and removed from the guide wire. Additionally, the diameter of the guide wire should be sufficiently larger than the diameter of the radiation source wire and protective sleeve to allow these two devices to be easily advanced and removed from within the guide wire lumen.
  • the inflatable region In use, the inflatable region is held in its expanded condition for a time sufficient to allow the radiation dosage to effect those cells which would otherwise cause restenosis to develop. Preferably, a sufficient dose of radiation can be delivered from about one minute to about sixty minutes to prevent development of restenosis.
  • the inflatable region presses against, or at least comes in close proximity to, the walls of the artery and in doing so centers the radiation source wire within the artery. Centering of this radiation source wire is important so that all portions of the artery receive as close to uniform and equal amounts of radiation as possible. Also, centering helps prevent radiation burns or hot spots from developing on portions of the target area.
  • catheter assemblies of the invention as described herein are generally employed after an atherectomy, percutaneous transluminal coronary angioplasty procedure, or before or after stent implantation to allow the radiation dose to be administered to an area where restenosis might otherwise develop within a coronary artery. It should be recognized by those skilled in the art that the catheter of the present invention can be used within a patient's vasculature system after vascular procedures other than a PTCA, stent implantation or atherectomy have been performed.
  • the catheter assembly of the present invention may be formed from conventional materials of construction which are described in detail in prior art patents referenced herein.
  • the materials forming the catheter body and protective sheath can be made out of relatively inelastic materials, such as polyethylene, polyvinyl chloride, polyesters and composite materials.
  • the various components may be joined by suitable adhesives such as the acrylonitrile based adhesive sold as Loctite 405 or by other known methods. Heat shrinking or heat bonding may also be employed when appropriate.
  • the present invention can be made with a material to form the segmented balloon elements or nodular balloon elements that is elastic (distensible) since compression of plaque for this particular application is not required.
  • An elastic material such as latex would be suitable for use.
  • the radiation source wire can be made from materials such as stainless steel, titanium, nickel titanium (NiTi) and platinum nickel alloys, or any NiTi alloys, or any polymers and composites. Variations can be made in the composition of the materials to vary properties.
  • the catheter assembly will allow delivery of radiation into the body lumen, such as a coronary artery, and is configured to provide the dosage over longer periods of time if necessary, due to the catheter's ability to allow blood to perfuse past the inflatable region during treatment.
  • the radiation delivered to a coronary artery should be in the range from about
  • the radiation dose can be delivered in less than thirty seconds, however, it is preferable that a longer time frame be used so that a more controlled, accurate dose can be administered in the target area.
  • the preferred radiation sources include iridium 192 as a gamma emitter, and phosphorus 32 as a beta -15- emitter. Further, it is contemplated that the radiation sources may provide beta particles or gamma rays to affect the target cells. However, alpha emitting radiation sources also can be used even though such radiation does not travel very far in human tissue. The use of beta and gamma emitting radiation sources is well known for treating and killing cancerous cells.

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Abstract

La présente invention concerne un cathéter d'application de rayonnement présentant une capacité d'irrigation de sang convenant au maintient de la perméabilité d'un vaisseau pendant un temps suffisamment long pour éviter l'application d'une source de rayonnement sur le vaisseau en question. Ce cathéter utilise une partie gonflable qui maintient et centre le cathéter dans le vaisseau, tout en permettant au sang de s'écouler normalement. La partie gonflable peut être composée d'éléments distincts de ballon segmenté, orientés de manière à créer un passage pour l'écoulement du sang lorsque les éléments du ballon sont gonflés. Par ailleurs, La partie gonflable peut être composée d'une pluralité d'éléments de ballon nodulaires se dilatant depuis le corps du cathéter allongé pour toucher la paroi du vaisseau, et permettre ainsi au sang de s'écouler à travers la partie gonflable pendant la radiothérapie.
PCT/US1999/003327 1998-02-17 1999-02-17 Catheter d'application de rayonnement avec capacite d'irrigation de sang WO1999040971A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2000531222A JP2002502677A (ja) 1998-02-17 1999-02-17 血液灌流能力を有する放射線供給カテーテル
EP99932478A EP1056518A1 (fr) 1998-02-17 1999-02-17 Catheter d'application de rayonnement avec capacite d'irrigation de sang

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US2432798A 1998-02-17 1998-02-17
US09/024,327 1998-02-17

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WO2002026323A1 (fr) * 2000-09-28 2002-04-04 Branch Metro Limited Catheter de centrage endoluminal
US6368266B1 (en) 1999-11-12 2002-04-09 Vascular Architects, Inc. Medical irradiation assembly and method
WO2004021892A1 (fr) * 2002-09-03 2004-03-18 Universite De Neuchatel Dispositif destine a stabiliser et/ou a positionner un instrument medical dans une cavite corporelle
WO2021202062A3 (fr) * 2020-04-03 2021-11-11 Covidien Lp Cathéter à ballonnet
WO2023125905A1 (fr) * 2021-12-31 2023-07-06 先健科技(深圳)有限公司 Endoprothèse pour radiothérapie
US12011184B2 (en) 2020-02-10 2024-06-18 Elixir Medical Corporation Methods and apparatus for plaque disruption

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WO2002026323A1 (fr) * 2000-09-28 2002-04-04 Branch Metro Limited Catheter de centrage endoluminal
WO2004021892A1 (fr) * 2002-09-03 2004-03-18 Universite De Neuchatel Dispositif destine a stabiliser et/ou a positionner un instrument medical dans une cavite corporelle
US12011184B2 (en) 2020-02-10 2024-06-18 Elixir Medical Corporation Methods and apparatus for plaque disruption
WO2021202062A3 (fr) * 2020-04-03 2021-11-11 Covidien Lp Cathéter à ballonnet
US11850385B2 (en) 2020-04-03 2023-12-26 Covidien Lp Balloon catheter
WO2023125905A1 (fr) * 2021-12-31 2023-07-06 先健科技(深圳)有限公司 Endoprothèse pour radiothérapie

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