WO2001008750A1 - Systeme d'introduction de catheter de brachytherapie - Google Patents

Systeme d'introduction de catheter de brachytherapie Download PDF

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Publication number
WO2001008750A1
WO2001008750A1 PCT/US2000/040378 US0040378W WO0108750A1 WO 2001008750 A1 WO2001008750 A1 WO 2001008750A1 US 0040378 W US0040378 W US 0040378W WO 0108750 A1 WO0108750 A1 WO 0108750A1
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WO
WIPO (PCT)
Prior art keywords
docking
stylet
guidewire
distal end
catheter
Prior art date
Application number
PCT/US2000/040378
Other languages
English (en)
Inventor
Brett A. Trauthen
Original Assignee
Radiance Medical 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 Radiance Medical Systems, Inc. filed Critical Radiance Medical Systems, Inc.
Priority to AU73862/00A priority Critical patent/AU7386200A/en
Publication of WO2001008750A1 publication Critical patent/WO2001008750A1/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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1007—Arrangements or means for the introduction of sources into the body

Definitions

  • This invention relates to shielded docking devices for catheters useful to deliver radiation to prevent or slow restenosis of an artery traumatized such as by percutaneous transluminal angioplasty (PTA) PTA treatment of the coronary arteries, percutaneous transluminal coronary angioplasty (PTCA), also known as balloon angioplasty, is the predominant treatment for coronary vessel stenosis.
  • PTA percutaneous transluminal angioplasty
  • PTCA percutaneous transluminal coronary angioplasty
  • PTCA percutaneous transluminal coronary angioplasty
  • the U.S. market constitutes roughly half of the total market for this procedure.
  • the increasing popularity of the PTCA procedure is attributable to its relatively high success rate, and its minimal mvasiveness compared with coronary by-pass surgery.
  • Patients treated by PTCA suffer from a high incidence of restenosis, with about 35% or more of all patients requiring repeat PTCA procedures or by-pass surgery, with attendant high cost and added patient risk.
  • Stents for example, dramatically reduce acute reclosure, and slow the clinical effects of smooth muscle cell proliferation by enlarging the minimum luminal diameter, but otherwise do nothing to slow the proliferate response to the angioplasty induced injury.
  • Restenosis is now believed to occur at least in part as a result of injury to the arterial wall during the lumen opening angioplasty procedure.
  • the injury initiates a repair response that is characterized by hyperplastic growth of the vascular smooth muscle cells in the region traumatized by the angioplasty.
  • Intimal hyperplasia or smooth muscle cell proliferation narrows the lumen that was opened by the angioplasty, regardless of the presence of a ste ⁇ t, thereby necessitating a repeat PTCA or other procedure to alleviate the restenosis.
  • IRT intravascular radiotherapy
  • the prior art contains many examples of catheter based radiation delivery systems.
  • the earliest systems disclose seed type sources inside closed end tubes.
  • An example of this type of system can be found in U.S. Patent No. 5,199,939 to Dake.
  • a delivery system is disclosed by U.S. Patent No. 5,683,345 to Waksman et al. where radioactive source seeds are hydraulically driven into a blind end catheter where they remain for the duration of the treatment, after which they are pumped back into the container.
  • Later disclosures integrated the source wire into catheters more like the type common in interventional cardiology.
  • a closed end lumen, through which is deployed a radioactive source wire is added to a conventional catheter construction.
  • radioactive source wire would be delivered through the catheter with a commercial type afterloader system produced by a manufacturer such as Nucletron, BV.
  • a commercial type afterloader system produced by a manufacturer such as Nucletron, BV.
  • the systems disclosed in the prior art are all similar in that the source resides in the center of the lumen during treatment.
  • the result of this is that the source energies must be higher in order to traverse the lumen of the blood vessel to get to the target tissue site in the vessel wall.
  • Higher energy sources can have undesirable features; first, likelihood of radiation inadvertently affecting untargeted tissue is higher; second, the higher energy sources are more hazardous to the medical staff and thus require additional shielding during storage and additional precaution during use; third, the source may or may not be exactly in the center of the lumen, so the dose calculations are subject to larger error factors. This last factor was discussed at the 1997 American Heart Association Meeting session on Radiation Therapy. In a paper discussing a seed system similar to the ones disclosed above, Tierstein reported that a 3X differential dose factor can exist between the near vessel wall and the far vessel wall in an eccentrically placed source.
  • U.S. Patent No. 5,059,166 to Fischell discloses an IRT method that relies on a radioactive stent that is permanently implanted in the blood vessel after completion of the lumen opening procedure. Close control of the radiation dose delivered to the patient by means of a permanently implanted stent is difficult to maintain because the dose is entirely determined by the activity of the stent at the particular time it is implanted. In addition, current stents are generally not removable without invasive procedures. The dose delivered to the blood vessel is also non-uniform because the tissue that is in contact with the individual strands of the stent receive a higher dosage than the tissue between the individual strands.
  • This non-uniform dose distribution may be especially disadvantageous if the stent incorporates a low penetration source such as a beta emitter.
  • U.S. Patent No. 5,302,168 to Hess teaches the use of a radioactive source contained in a flexible carrier with remotely manipulated windows.
  • H. B ttcher, et al. of the Johann Wolfgang Goerthe University Medical Center, Frankfurt, Germany report in November 1992 of having treated human superficial femoral arteries with a similar endoluminal radiation source.
  • These radioactive wire type methods generally require use of a relatively high activity source to deliver an effective dose. Accordingly, measures must be taken to ensure that the source is maintained reasonably near the center of the lumen to prevent localized overexposure of tissue to the radiation source.
  • Use of these higher activity sources also dictates use of expensive shielding and other equipment for safe handling of the source.
  • a brachytherapy catheter docking device which allows a brachytherapy catheter to be rapidly coupled to the proximal end of a guidewire and/or guiding catheter, and advanced into the patient while remaining shielded to minimize exposure of clinical personnel to the radiation source.
  • the docking system for facilitating entry of a radiation delivery catheter into a patient.
  • the docking system comprises a housing, having a proximal end, a distal end, and a lumen extending therethrough.
  • a radiation delivery catheter is moveably positioned within the housing, the catheter having a guidewire lumen.
  • a docking stylet is moveably positioned with the guidewire lumen.
  • the housing comprises a material which blocks radiation.
  • the docking stylet comprises a proximal end and a distal end, with a docking structure on the distal end.
  • the docking structure comprises an axiall ⁇ extending tubular structure for coupling with the proximal end of a guidewire in position within the patient.
  • the docking stylet is dimensioned to removably reside within the guidewire lumen of the radiation delivery catheter, and to couple with the procedure guidewire in position within the patient.
  • the diameter of the docking stylet is generally within the range of from about 0.008" to about 0.020".
  • the axial length of the docking stylet is preferably longer than the axial length of the guidewire lumen, such as on the order of from about 20 cm to about 50 cm for a rapid exchange PTCA catheter, and from about 120 cm to about 160 cm for an over the wire PTCA catheter.
  • a rapid docking radiation delivery catheter comprising an elongate flexible tubular body, having a proximal end and a distal end.
  • a radiation source is carried by the tubular body, near the distal end thereof.
  • the radiation source may be carried on the balloon, or in the catheter shaft.
  • the source may comprise any of a variety of substrates for containing an isotope, such as seeds, pellets, wires, tubular elements, implantable radioactive stents and flexible balloon layers or walls.
  • a guidewire lumen extends through at least a distal portion of the tubular body, and a docking stylet is positioned within at least a portion of the guidewire lumen.
  • the docking stylet comprises a distal surface structure for engaging a complementary surface structure on the proximal end of a guidewire.
  • the docking stylet has an axial length within the range of from about 20 cm to about 50 cm, and a diameter within the range of from about .008" to about .020".
  • the method comprises the steps of providing a radiation delivery catheter having a guidewire lumen, a radioactive source near a distal end thereof, a radiation shield axially moveably positioned on the catheter and surrounding the radiation source, and a docking stylet in the guidewire lumen.
  • a distal end of the docking stylet is coupled to a proximal end of the guidewire, and the radiation source is distally advanced over the docking stylet and onto the guidewire.
  • the method may further comprise the step of advancing the docking stylet axially within the guidewire lumen prior to the coupling step.
  • the coupling step comprises bringing a coupling surface structure on the distal end of the stylet into engagement with a complementary surface structure on the proximal end of the guidewire
  • the coupling surface structure on the distal end of the stylet comprises a tubular extension
  • the bringing into engagement step comprises advancing the proximal end of the guidewire into the tubular extension
  • FIG. 1 is an exploded perspective view of a docking device including a balloon catheter with a docking stylet in accordance with the present invention.
  • Figure 2 is an elevational cross section through the docking device of Figure 1.
  • Figure 3 is a side elevational, perspective view of a distal end of a docking stylet extending from a docking device, and a proximal end of a procedure guidewire having complementary surface profiles.
  • Figure 4 is a side elevational cross section of the docking stylet in accordance with the present invention.
  • the docking device 10 comprises a housing 12, having a proximal end 14 and a distal end 16.
  • a lumen 18 extends therethrough, between a proximal access port 20 and a distal exit port 22.
  • the housing 12 may be made out of any of a variety of materials which are capable of blocking radiation from a source placed within the lumen 18.
  • the brachytherapy docking device 10 is intended for use with a brachytherapy catheter having a beta radiation source thereon.
  • the housing 12 preferably comprises a material which, taking into account the activity of the source and the lateral path length through the housing from the source to the outside of the housing, is sufficient to attenuate the radiation so that it substantially or completely blocks radiation from the source.
  • the housing 12 may be machined or injection molded from any of a variety of radiation blocking materials such as acrylic, polycarbonate, or PVC.
  • the housing 12 can have any of a variety of dimensions, depending upon the brachytherapy catheter and source activity.
  • the brachytherapy docking device 10 is intended for use with an inflatable balloon having a radioactive beta source thereon, similar to that disclosed in United States Patent No. 5,782,742 to Crocker et al., the disclosure of which is incorporated in its entirety herein by reference.
  • One embodiment of the balloon has an inflated diameter of about 3 mm, and the axial length of the source on the balloon is about 2 cm.
  • the housing 12 has an axial length of about 2-5", depending on the length of the source, a minimum transverse cross- section through the source carrying portion of the housing of about 1cm, and the central lumen 18 is coaxially positioned within the housing 12.
  • the cross-sectional configuration of at least a portion of the housing may be a polygon such as a pentagon or a hexagon. However, any of a variety of other cross-sectional configurations can be utilized as will be apparent to those of skill in the art in view of the disclosure herein.
  • the docking device 10 and associated stylet 40 can be used to facilitate loading of any of a variety of radioactive devices onto guidewires or into introducer sheaths or other body access structures in addition to the balloon source described above.
  • a stent deployment catheter such as a balloon catheter having a radioactive stent thereon can be readily loaded onto the proximal end of the guidewire using the devices and methods described herein.
  • guidewire placed radioactive wires or seed train catheters may also be introduced using the present invention to reduce potential radiation exposure of the clinical personnel.
  • the housing 12 is preferably provided with one or more docking guides for engaging the proximal end of the guide catheter to permit rapid advancement of the source into the guide catheter.
  • the docking guide on the housing 12 may comprise any of a variety of structures for engaging the proximal end of the guiding catheter.
  • the guide will preferably have a surface configuration which is complementary to a surface configuration on the guiding catheter.
  • one or more projections on the housing 12 may be provided for extending into the proximal opening of the guiding catheter.
  • Guiding pins may be provided on one of the housing 12 or guiding catheter, for engaging one or more corresponding recesses on the other of the housing 12 or guiding catheter.
  • a guide tube 24 extends distally from the housing 12.
  • Guide tube 24 has a central lumen 25 which aligns with lumen 18, to provide a continuous access pathway through the docking device 10.
  • Guide tube 24 preferably comprises a material capable of blocking or substantially reducing radiation from the beta source.
  • the guide tube 24 comprises a PVC extrusion, having an inside diameter of from about 2 to about 2.5 mm and an outside diameter of about 3.0 mm, and extends for a distance of about 1.25" (approximately 3 cm) beyond the distal end of the housing 12.
  • the proximal end 27 of guide tube 24 may be attached to the distal end 16 of the housing 12, or the guide tube 24 may extend proximally throughout the entire length or substantially the entire length of the housing 12, depending upon desired performance and manufacturing issues.
  • the guide tube 24 has a length of about 4", and extends throughout substantially the entire length of the housing 12 which has a length of about 2.5".
  • the distal portion of guide tube 24 extends distally beyond the distal end 16 of housing 12 by at least about 0.5 cm and, in the illustrated embodiment, by about 1.25" (approximately 3 cm). This enables the guide tube 24 to be inserted within the proximal end of a guiding catheter (not illustrated) which has been previously positioned within the patient as discussed in greater detail below.
  • the proximal access port 20 is provided with a connector 26 such as a standard luer connector.
  • a standard male lure 28 is adapted for engagement with the luer connector 26, to couple a standard Touhey Borst fitting 30 thereon, as is understood in the art.
  • the distal end 16 of the housing 12 in Figure 1 is provided with a releasable connector such as thread 30, for engaging with a complementary thread 32 on distal cap 34.
  • Cap 34 includes a cavity or blind lumen 36 for receiving the distal extension of the guide tube 24.
  • Cap 34 preferably comprises a radiation blocking material similar to or the same as that utilized to construct the housing 12.
  • the cap 34 has an axial length of about 2", and an outside diameter which tapers distally from a proximal diameter of about 1cm to a distal diameter of about .25cm.
  • the proximal end of cap 34 is provided with a male thread 32, for engaging a female thread on the distal end 16 of the housing 12.
  • Blind lumen 36 has an inside diameter of about 4mm.
  • the docking device 10 is further provided with a docking stylet 40, having a proximal end 42, a distal end 44, and an elongate flexible body 46.
  • the docking stylet 40 is preferably preloaded within the guidewire lumen of the radiation delivery catheter at the point of manufacture, with the distal end 44 positioned within or extending distally beyond the distal tip of the radiation delivery catheter.
  • the cap 34 can be removed and the docking stylet distally advanced to a position such that the radiation source remains positioned within the housing 12 or guide tube 24 and the distal end 44 of the docking stylet 40 is exposed beyond the distal exit port 22 to enable coupling to a guidewire as will be discussed.
  • the axial length of docking stylet 40 may extend anywhere within the range from about 10 cm to longer than the radiation delivery catheter (e.g. 120 cm or longer).
  • the axial length of the docking stylet 40 should be sufficient to extend from the distal end of the catheter proximally beyond the proximal opening of the guidewire lumen.
  • a docking stylet 40 on the order of from about 120 to about 160 cm may be desirable in an over the wire embodiment, and a docking stylet 40 having a length on the order from about 20 cm to about 50 cm may be used in a rapid exchange embodiment of the radiation delivery catheter, where the proximal guidewire access port is positioned within about 20 cm from the distal end of the radiation delivery catheter.
  • the distal end 44 of the docking stylet 40 will be able to be advanced sufficiently beyond the source to enable convenient coupling to the guidewire.
  • the flexible body 46 may comprise any of a variety of structures which are well known in the guidewire art.
  • hypodermic needle tubing, single filament solid core wire, spring coil or polymeric extrusion may all be provided with docking structures in accordance with the present invention
  • the diameter of the docking stylet 40 is selected to cooperate with a guidewire to which the docking stylet is to be coupled
  • the docking stylet will generally have a diameter within the range of from about 0.008" to about 0.020", depending upon the intended procedure.
  • the docking stylet 40 will generally have a diameter within the range of from about 0.009" to about 0.014".
  • Docking stylet 40 in accordance with the present invention can be provided in an array of sizes, to cooperate with the standard guidewires available on the market.
  • the docking stylet 40 should be sufficiently close in diameter to the corresponding guidewire to enable a smooth sliding transition between the docking stylet and the guidewire, to enable the radiation delivery catheter to be smoothly advanced across the transition and into the patient.
  • the distal end 44 of the docking stylet 40 is provided with a coupling surface structure which permits coupling to the proximal end of the procedure guidewire which has either been left in place within the patient such as from the preceding angioplasty, or which has been positioned within the patient solely for the purpose of introducing the radiation delivery catheter.
  • the proximal end 48 of a standard guidewire 50 is provided with a coupling structure 52 to accommodate the coupling of a second guidewire to enable exchange of over the wire type catheters.
  • the coupling structure 52 comprises a proximal end of the guidewire 50 having one or more slight bends to provide a friction fit within the tubular docking guide 58 on the distal end of the stylet 40 as discussed below.
  • the male-female relationship of the coupling structures can be reversed, such that the coupling structure 52 comprises an axially extending recess.
  • the distal end 44 of the docking stylet 40 is provided with a complementary distally extending extension.
  • the extension is adapted to fit coaxially within the recess on the proximal end 48 of the guidewire 50.
  • the extension or interior wall of the corresponding recess may be provided with any of a variety of sur ace structures to enhance friction or otherwise improve retention between the two components.
  • any of a wide variety of complementary surface structures can be provided on the distal end 44 of the stylet 40, to enable coupling with the proximal end of the procedure guidewire. Examples specific docking configurations are illustrated, for example, in U.S.
  • Patent No. 5,546,958 to Thorud et al. U.S. Patent No. 5,605,163 to Hani; and U.S. Patent No. 5,792,075 to Schwager, the disclosures of which are incorporated in their entireties herein by reference.
  • the docking stylet 40 comprises an elongate body having a diameter within the range of from about 0.010 inches to about 0.020 inches or other diameter depending upon the dimensions of the procedure catheter with which it is to be used.
  • the body has a length generally within the range of from about 20cm to about 50cm.
  • the distal end 44 of the stylet 40 is provided with a docking guide 58 which in the illustrated embodiment is in the form of a tube.
  • the docking guide has a proximal end 60, a distal end 62, and a central lumen 64 extending therebetween.
  • the proximal end is connected to the body such as by soldering, welding, crimping, adhesives or the like, in the illustrated embodiment, the distal end of the body is provided with a tapered tip to fit within the proximal end 60 of the tube 58.
  • the taper reduces the OD of the body to about 0.008 inches or less to facilitate a secure attachment to the tube 58.
  • the central lumen 64 is thus available to receive the proximal end of a guidewire from the interventional procedure.
  • the illustrated tube 58 has a length in the range of from about 2 to about 8cm, and in many embodiments within the range of from about 3 to about 5cm.
  • the tube 58 will generally have an inside diameter within the range of from about 0.005 inches to about 0.014 inches, and an outside diameter within the range of from about 0.010 inches to about 0.020 inches.
  • Other dimensions can also be used, depending upon the dimensions of the other devices in conjunction with which the stylet is to be used.
  • the distal end 62 of the tube can be modified to enhance rapid placement of the proximal end of the guidewire therein.
  • One modification is to cut the distal end of the tube 58 at an angle to provide an enlarged, elliptical access opening.
  • the distal end 62 of the tube 58 can be provided with a radially outwardly extending flare in the distal direction to provide a funnel shape for easier docking Distal opening inside diameters on the order of from about 120% to about 500% or greater than the ID of the tube 58 may be desirable
  • the tube 58 can extend for the entire length of the stylet, such as by constructing the entire stylet from a length of hypotube or from a tubular polymeric extrusion having lengths and diameters as discussed above
  • the tube can have a constant diameter throughout, or can be provided with a flared, stepped, or otherwise enlarged distal end for reasons discussed above
  • the brachytherapy docking device 10 in accordance with the present invention will be described below in connection with a percutaneous transluminal coronary angioplasty (PTCA) procedure.
  • the docking device 10 may be utilized in connection with radiation delivery following any of a variety of other procedures which injure the vessel wall or otherwise increase the risk of smooth muscle cell proliferation or intimal hyperplasia thereby potentially benefiting from a localized dose of radiation.
  • the docking device 10 of the present invention can be readily modified by those of skill in the art in view of the disclosure herein for use with radiation delivery devices adapted for delivery to locations within the body other than the vascular system.
  • soft tissue access devices such as pins or wires for carrying a radioactive source into target sites such as the breast, prostate gland, brain, and other locations in the body may be readily used.
  • docking stylet of the present invention is not limited to the context of radiation delivery catheters.
  • standard balloon angioplasty catheters, imaging catheters, drug delivery catheters, infusion catheters, stent delivery catheters, stent sizing catheters and the like may be provided with a docking stylet prepositioned in the guidewire lumen
  • the distal end of the docking stylet may be initially positioned within the guidewire lumen, or may extend distally beyond the end of the guidewire lumen.
  • the docking stylet is advanced sufficiently beyond the distal end of the catheter to enable the clinician to couple the docking stylet to the proximal end of a guidewire in position within the patient.
  • the catheter may thereafter be advanced over the stylet, across the junction between the stylet and the guidewire, and over the guidewire into the patient
  • a guiding catheter having a pre-bent distal tip is percutaneously introduced at a remote location such as the femoral artery, using a conventional Seldmger technique
  • the guide catheter is advanced retrograde until it reaches the ascending aorta, with the distal tip seated in the ostium of a desired coronary artery. Steering is accomplished during transluminal advancement by torqumg the proximal end of the guide catheter as needed until the distal tip is positioned in the ostium.
  • An elongate flexible guidewire is then advanced through and out the distal end of the guide catheter, and negotiated through the tortuous vasculature of the coronary arteries until it crosses a lesion to be dilated.
  • a dilatation catheter is thereafter advanced along the guidewire, until the dilatation balloon is positioned within the lesion.
  • the balloon is inflated one or more times to an inflation pressure on the order of 6 to 12 atmospheres or higher to dilate the lesion.
  • Balloon catheters sized for the coronary arteries may inflate to a diameter in the range of from about 2 to about 4 mm. Following dilatation, the balloon is deflated and the catheter is proximally withdrawn from the patient, leaving the guiding catheter and the guidewire in place.
  • the docking stylet 40 is preferably loaded within the delivery catheter and in turn within the brachytherapy docking device 10 of the present invention at the point of manufacture, and shipped as a unit to the clinical site.
  • the assembly is removed from its packaging at the clinical site, and the distal cap 34 is removed.
  • the docking stylet is advanced distally so that it is accessible beyond the distal exit port 22 of the guide tube 24.
  • the docking stylet is then docked to the proximal end of the procedure guidewire in place within the patient.
  • the housing 12 may then be advanced distally, with the radiation delivery source positioned therein, until the distal end of guide tube 24 is positioned within the proximal end of the guiding catheter.
  • the clinician then advances the radiation delivery catheter distally, causing the radiation source to pass axially through the housing 12, through the guide tube 24 and out of the distal exit port 22.
  • the catheter is further advanced distally along docking stylet, onto and along the guidewire until the radiation delivery source is positioned within the treatment site.
  • the radiation delivery source is thereafter left at the treatment site for a sufficient radiation delivery period of time, taking into account the structure of the catheter and activity of the source, to effect delivery of a therapeutic dose of radiation.
  • the balloon may be inflated and deflated two or more times to permit intermittent perfusion.
  • the radiation delivery catheter may be provided with a perfusion conduit through the balioon to enable inflation of the radiation delivery balloon throughout the radiation delivery period.
  • the radiation delivery source is proximally withdrawn from the patient until it is positioned within the docking device 10.
  • the Touhey-Borst valve may thereafter be tightened against the catheter shaft, as is understood in the art, to lock the radiation source within the docking device 10, and the assembly of the radiation source and the docking device 10 may thereafter be disposed of in accordance with radiation disposal procedures in place at the clinical site.
  • the guidewire and guiding catheter may thereafter be removed from the patient, or left in place for subsequent diagnostic or therapeutic intervention.

Abstract

L'invention concerne un système (10) d'introduction de brachythérapie qui protège le personnel soignant du rayonnement provenant d'un dispositif d'administration de rayonnement. Dans une forme de réalisation, le système d'introduction (10) comporte un cathéter d'administration de rayonnement qui présente une lumière de fil de guidage, et est placé à l'intérieur d'un logement (12) tubulaire de manière à entourer la source d'administration de rayonnement. Un stylet (40) d'introduction est placé à l'intérieur d'au moins une partie de la lumière de fil de guidage. Le stylet d'introduction peut être couplé à l'extrémité proximale d'un fil de guidage, en vue d'une introduction rapide de la source de rayonnement, placée sur le fil de guidage, dans le patient. Des procédés d'utilisation du système d'introduction sont également inclus.
PCT/US2000/040378 1999-08-02 2000-07-13 Systeme d'introduction de catheter de brachytherapie WO2001008750A1 (fr)

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AU73862/00A AU7386200A (en) 1999-08-02 2000-07-13 Brachytherapy catheter docking system

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US36606699A 1999-08-02 1999-08-02
US09/366,066 1999-08-02

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2010336486B2 (en) * 2009-12-23 2015-12-17 Medi-Physics, Inc. Braced brachytherapy needle

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4827941A (en) * 1987-12-23 1989-05-09 Advanced Cardiovascular Systems, Inc. Extendable guidewire for cardiovascular procedures
US5605530A (en) * 1995-03-23 1997-02-25 Fischell; Robert E. System for safe implantation of radioisotope stents
US5683345A (en) * 1994-10-27 1997-11-04 Novoste Corporation Method and apparatus for treating a desired area in the vascular system of a patient
US5863284A (en) * 1995-11-13 1999-01-26 Localmed, Inc. Devices and methods for radiation treatment of an internal body organ

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4827941A (en) * 1987-12-23 1989-05-09 Advanced Cardiovascular Systems, Inc. Extendable guidewire for cardiovascular procedures
US5683345A (en) * 1994-10-27 1997-11-04 Novoste Corporation Method and apparatus for treating a desired area in the vascular system of a patient
US5605530A (en) * 1995-03-23 1997-02-25 Fischell; Robert E. System for safe implantation of radioisotope stents
US5863284A (en) * 1995-11-13 1999-01-26 Localmed, Inc. Devices and methods for radiation treatment of an internal body organ

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2010336486B2 (en) * 2009-12-23 2015-12-17 Medi-Physics, Inc. Braced brachytherapy needle

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