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WO1993004735A1 - Procede et dispositif de traitement de la restenose - Google Patents

Procede et dispositif de traitement de la restenose Download PDF

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Publication number
WO1993004735A1
WO1993004735A1 PCT/US1992/007447 US9207447W WO9304735A1 WO 1993004735 A1 WO1993004735 A1 WO 1993004735A1 US 9207447 W US9207447 W US 9207447W WO 9304735 A1 WO9304735 A1 WO 9304735A1
Authority
WO
WIPO (PCT)
Prior art keywords
angioplasty
radiation
dose
administered
radioactive
Prior art date
Application number
PCT/US1992/007447
Other languages
English (en)
Inventor
Robert L. Hess
Arie Shefer
Neal L. Eigler
James S. Whiting
Original Assignee
Cedars-Sinai Medical Center
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
Priority claimed from US07/755,480 external-priority patent/US5302168A/en
Application filed by Cedars-Sinai Medical Center filed Critical Cedars-Sinai Medical Center
Publication of WO1993004735A1 publication Critical patent/WO1993004735A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22068—Centering
    • 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
    • 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
    • A61N2005/1023—Means for creating a row of seeds, e.g. spacers

Definitions

  • This invention relates generally to angioplasty and more particularly to a method and apparatus for preventing restenosis after angioplasty or other stenosis treatment.
  • ischemic heart disease 1 The most common cause of death in industrial countries is ischemic heart disease 1 which, generally speaking, is an imbalance between myocardial oxygen supply and demand. This imbalance is most often due to obstruction of large coronary arteries by sclerotic plaque and is related to either an absolute decrease in coronary blood flow or an inability to increase coronary blood flow relative to the needs of the heart. 1 Ischemic heart disease is most commonly associated with chest pain, an acute heart attack, an abnormal ventricular rhythm and sudden death. Although various medical and surgical therapies may improve the quality of lifestyle of many patients with this disease, these therapies do not favorably change the underlying cause for the coronary vessel narrowing, nor do they stop its progression.
  • catheters have been developed which may be effectively inserted into blood vessels and maneuvered through a vascular tree.
  • a balloon may be used with such catheters to expand inside the vessel and to open blockages found therein.
  • a guiding catheter is percutaneously introduced into the vascular system of a patient through an artery and advanced therein until the distal tip of the guiding catheter is appropriately positioned.
  • a dilation catheter having a balloon on the distal end thereof and a guide wire are slidably disposed and introduced through the guiding catheter.
  • the guide wire is first advanced through the distal tip of the guiding catheter until the distal end of the guide wire crosses the lesion to be dilated.
  • the dilation catheter is then advanced over the previously introduced guide wire until the dilation balloon on the distal extremity of the dilation catheter is properly positioned inside the lesion.
  • the balloon portion of the dilation catheter is then inflated to a predetermined size to radially compress the atherosclerotic plaque of the lesion against the inside of the artery wall to thereby reduce the annular stenosed area. After a period of time, the balloon is deflated so that blood flow is resumed, allowing the dilation catheter to be removed.
  • a major problem encountered in a significant number of patients treated by this procedure is the subsequent narrowing of the artery after the expansion treatment.
  • Palmaz discloses an expansible vascular graft which is expanded within a blood vessel by an angioplasty balloon to dilate and expand the lumen of the blood vessel.
  • the Palmaz method and apparatus leaves the expandable vascular graft in place to ideally prevent recurrence of stenosis in the body passageway.
  • the present invention is believed to provide a unique method and apparatus to reduce the restenosis rate of occurrence following an angioplasty or like-intended procedure.
  • PTCA percutaneous transluminal coronary angioplasty
  • a significant percentage of treated arteries experience a reoccurrence of the narrowing, also called restenosis, and a seriously reduced blood flow.
  • restenosis occurs in 30-40% of cases following successful PTCA and is most frequently observed between 3 and 6 months after the procedure.
  • Late restenosis in the months after angioplasty reduces the initial success rate of 90% to 60-70% after six months.
  • Two (2) approaches are currently employed to reduce restenosis.
  • One approach involves the use of a revascularization device, such as the laser catheter, thermal catheter or stent to debulk plaque and create a smooth lumen to minimize turbulence and platelet aggregation along the vessel wall.
  • Another approach to reduce restenosis involves infusing a drug which modulates cell growth into the target artery before, during or after the angioplasty to inhibit the proliferation of smooth muscle cells.
  • antiplatelet agents such as aspirin and dipyridamole
  • anticoagulants such as heparin
  • the present invention satisfies this need and provides related advantages as well.
  • the purpose of the invention is to provide method and apparatus to significantly reduce restenosis rates of occurrence following an angioplasty procedure.
  • method and apparatus for exposing the dilated lesion to a radiation dose that will affect smooth muscle cell growth There is provided a catheter which has at its distal end a radioactive source, the source being maneuverable to the site of a lesion which has been dilated or removed, the apparatus allowing the site to be exposed to the radiation dose that will affect smooth muscle cells such that the rapid growth of such cells can be prevented, thereby controlling restenosis.
  • a method for treatment and post-treatment of the stenosed region of an artery comprising the steps of: reducing the annular stenosed area within an artery; and applying a radioactive dose to the area of reduced stenosis.
  • a method for treatment and post-treatment of the stenosed region of an artery after reduction of said region by angioplasty or other means comprising the step of applying a radioactive dose to said reduced region of the artery.
  • apparatus for post-treatment of a stenosed region of an artery that has been reduced by angioplasty or other means comprising: radioactive dose means; and positioning means operatively connected to said dose means to position said dose means within the stenosed region of an artery that has been reduced by angioplasty or other means.
  • the present invention describes a method for preventing restenosis after any interventional procedure, including but not limited to balloon and laser angioplasty, stents and atherectomy.
  • Low dose, local irradiation is delivered to the site of intervention to prevent and/or minimize excessive cell proliferation.
  • the irradiating source may be located external to the site, or may be permanently or removably located within the subject vessel.
  • the low dose local irradiation may also be delivered alone or in combination with radiosensitizing agents that enhance the tissue reaction to radiation.
  • the irradiation may be delivered during the angioplasty session, during the same hospitalization, or at some later time.
  • a further aspect of the invention therefore involves a method for the local delivery of low dose external irradiation to a vessel wall following angioplasty.
  • an ink mark, tatoo or the like is placed on the subject's chest to indicate the place where to administer external irradiation.
  • This mark or the like is then used to position the external radiation port, which usually measures 4 square centimeters.
  • the port can be widened or narrowed using appropriate shielding, depending upon the size of the lesion, to circumscribe the area to be irradiated.
  • the marked area is then irradiated in a single dose or in a fractionated dose from an external source.
  • the irradiation can be combined with the interventional procedure in the same session, or at some later time, preferably within 72 hours after the procedure.
  • the irradiation may also be combined with radiosensitizers, such as bromodioxyuridine and the like.
  • radiosensitizers such as bromodioxyuridine and the like.
  • These agents may be administered systemically (e.g., administered by the oral, mjectable or rectal route), or locally, through a perforated balloon catheter introduced percutaneously.
  • the radiosensitizers enhance the tissue reaction to radiation, thereby reducing the radiation dose required without diminishing the radiation effect.
  • the recommended dosage range of dibromodioxyuridine is between 20-500 mg administered subcutaneously.
  • Still another aspect of the invention involves a method for the local delivery of low dose intravascular irradiation by a removable or non-removable source after an interventional procedure.
  • a radioactive iridium wire or the like is inserted directly through a catheter and positioned precisely at the target site during the procedure.
  • the target is then irradiated in a single dose.
  • the irradiation may also be combined with at least one radiosensitizer.
  • FIG. 1 is a partial cross-sectional view of an embodiment of the invention wherein said dose applying means is a radioactive element contained within a wire wound housing for radioactive containment, the housing having a window cut-out.
  • a larger wire wound sheath covers the window during insertion and removal, the sheath being withdrawn to expose the radioactive element at the lesion site.
  • FIG. 2 is a partial perspective view of an alternate embodiment having a radioactive dose means positioned upon the balloon of an expandable balloon catheter, said balloon catheter being provided with a means or perfusion to allow blood flow during the time the balloon is inflated.
  • FIG. 3 is an enlarged partial cross-sectional view of a portion of the apparatus shown in FIG. 2.
  • FIG. 4 is a partial perspective view of the apparatus shown in FIGS. 2 and 3 upon expansion of the balloon portion of the apparatus.
  • FIG. 5 is a partial perspective view of another embodiment of the invention wherein the radioactive dose means is an element that may be contained within a complementary containment means provided with a remotely actuated window.
  • FIG. 6 is a partial perspective cross-sectional view of a catheter tip containing radioactive dose means showing the remotely actuated window.
  • FIG. 7 is a partial perspective cross-sectional view of an alternate embodiment further including a stent wherein said radioactive dose means is in the form of a coating of radioactive material on the stent.
  • FIG. 8 is a partial cross-sectional view of the device shown in
  • FIG. 7 after expansion of the stent shown in FIG. 7.
  • FIG. 9 is a partial perspective view of the stent illustrated in FIGS. 7 and 8 wherein the stent is implanted within the artery.
  • FIG. 10 is a photomicrograph of a normal central ear artery from a New Zealand white rabbit following formalin fixation and hematoxylin-eosin staining.
  • FIG. 11 is a photomicrograph of a dilated central ear artery from a New Zealand white rabbit fed a cholesterol rich diet.
  • the central ear artery had been fixed in formalin and stained with hematoxylin-eosin.
  • FIG. 12 is a photomicrograph of the central ear artery from a
  • New Zealand white rabbit following balloon dilatation without irradiation The central ear artery had been fixed in formalin and stained with hematoxylin- eosin.
  • FIG. 13 is another photomicrograph of the central ear artery from a New Zealand white rabbit following balloon dilatation without irradiation.
  • the central ear artery had been fixed in formalin and stained with hematoxylin-eosin.
  • FIG. 14 is a photomicrograph of the central ear artery from a New Zealand white rabbit irradiated immediately following balloon dilatation. As above, the central ear artery had been fixed in formalin and stained with hematoxylin-eosin.
  • FIG. 15 is a photomicrograph of the central ear artery from a New Zealand white rabbit irradiated one (1) day after balloon dilatation.
  • the central ear artery had been fixed in formalin and stained with hematoxylin- eosin.
  • FIG. 16 is a photomicrograph of the central ear artery from a
  • New Zealand white rabbit irradiated two (2) days after balloon dilatation.
  • the central ear artery had been fixed in formalin and stained with hematoxylin- eosin.
  • FIGS. 17A-C show a further aspect of the invention wherein the dose applying means includes radioactive seeds encapsulated in a heat shrinkable polymer catheter tip.
  • FIG. 17A shows a catheter shaft and polymeric tubing;
  • FIG. 17B shows a plurality of radioactive seeds which are separated by meltable material; and
  • FIG. 17C shows the tubing after heat shrinking.
  • FIG. 1 illustrates the apparatus and method for preventing restenosis of an artery that has been enlarged by angioplasty or other procedure.
  • apparatus shown generally at 10 is positioned within artery segment 12 having lesion site 14 which has previously been enlarged by angioplasty or other procedure such that atherosclerotic plaque 16 has been radially compressed by expansion of the balloon portion of an angioplasty device (not shown) or removed by other means.
  • Device 10 having distal end 18 with tip 20 and wire wound housing 22 is positioned such that housing 22 is positioned within the lesion site 14.
  • Housing 22 contains radioactive dose means 30 and is provided with window cut-out 32.
  • Device 10 includes a wire wound retractable sheath 24 and catheter shaft 26 with guide wire and guide wire port 28.
  • a radioactive dose means 30 is moveable by advancing or retracting catheter shaft 26 which may be referred to as a positioning means. Sheath 24 is drawn back when the radioactive dose means is positioned directly proximate the lesion site 14 such that window cut ⁇ out 32 is opened to expose the lesion site 14, which has been previously dilated, to a radiation dose that will affect the smooth muscle cells/plaque.
  • FIG. 2 there is illustrated a device shown generally at 34 which is an alternate embodiment of the invention further including an angioplasty balloon 36 with dose means in the form of radioactive elements 38 attached thereto.
  • Device 34 includes catheter shaft 40 having perfusion capabilities provided by holes 41 positioned proximately and distally to the balloon portion.
  • FIG. 3 shows in expanded view details of balloon 36 of FIG.
  • Lumen 42 makes provision for guide wire capability and contains perfusion holes.
  • Lumen 44 is the lumen which provides the passage to inflate the balloon from the inflation port 45 shown in FIG. 2 at the proximal end of the device 34.
  • the radioactive elements 38 are not shown in FIG. 3.
  • FIG. 4 illustrates the device 34 of FIGS. 2 and 3 wherein the balloon 36 is expanded in the vicinity of the lesion site 46, and the radioactive elements 38 are forced into contact with the lesion.
  • lesion site includes those lesions which have been treated with balloon angioplasty, those lesions that have been treated by an atherectomy or laser angioplasty, those lesions that have been treated by rotational atherectomy or any other means of compressing or removing the material of the lesion which may cause trauma to the artery. It is this trauma which causes the proliferation of smooth muscle cells which method and apparatus of the subject invention is intended to inhibit.
  • radioactive dose means bombardment by particles emitted from radioactive materials including, but not limited to, materials such as Radon 222, Gold 198, Strontium 90, Radium 192, and Iodine 125. These materials may be incorporated into or delivered in a solid, liquid, or gaseous form, and the delivery of such forms is considered to be within the scope of the subject invention.
  • FIG. 5 illustrates an alternate embodiment of the subject invention in the form of apparatus shown generally at 48.
  • Sheath 50 of said device is preferably made from a helically wound wire member to provide a measure of shielding for the radioactive dose means.
  • Device 48 includes positioning means 52 which is a motion wire providing slidable motion of the radioactive dose means 54 within the sheath.
  • Radioactive dose means 54 is thus positionable proximate to the lesion site 56 of artery segment 58 and retractable within sheath 50 for insertion and removal within the artery segment 58.
  • FIG. 6 illustrates yet another embodiment of the subject invention in the form of the device shown generally at 60, similar to the device 10 shown in FIG. 1.
  • device 60 is comprised of the shaft portion 62 and contains at its distal end a canister 64 containing the radioactive dose means.
  • This canister 64 has a remotely actuated window 66 which can be actuated through port 68 to expose the radioactive dose means to the lesion 70.
  • FIGS. 7, 8, and 9 illustrate yet another embodiment of the subject invention wherein a device shown generally at 72 is an inflatable stent delivery balloon system for delivery and expansion of stent 74.
  • Stent 74 may be removable or may be a permanent implant.
  • the radioactive dose means has to be carefully chosen in terms of dose level and half-life in order to limit the total radiation dose.
  • the radioactive dose means is associated with stent 74 and may be included as a cladding, a coating, an additive within the basic stent material itself, or an attachment by other means to the stent.
  • the device 72 includes an inflatable balloon dilation catheter to position stent 74 within lesion 76.
  • FIG. 8 shows the expanded balloon of the stent delivery system 78 having dilated stent 74 in close proximal contact with lesion 76.
  • FIG. 9 shows the stent 74 in place within lesion 76 with the stent deEvery system having been removed from the artery.
  • the methods of the invention include the treatment and post-treatment of an annularly stenosed region of an artery.
  • Most methods of treatment currently available cause some trauma to the artery.
  • the artery in response to this trauma proliferates the growth of smooth muscle cells in many cases, and this results in restenosis at the site of the original stenosis - usually within a six-month period.
  • the post- treatment therefore consists of exposing the treated region of the stenosis to a radiation dose which is sufficient to retard or halt the proliferation of smooth muscle cells.
  • the rabbits were also anesthetized for conditioning with ketamine 35 milligrams per kilogram and xylazine 5 milligrams per kilogram (mg/kg) by an intramuscular injection (EM).
  • EM intramuscular injection
  • the rabbits were then tattooed in the left ear for identification, and treated with 0.1 milliliter of 1% ivermectin by IM injection for the prevention and prophylaxis of parasites.
  • the animals were fasted for 12 hours prior to the procedure; however, water was not withheld.
  • Group D - Irradiation was applied three (3) days after the balloon dilatation.
  • Group E - Irradiation was applied (3) days after the balloon dilatation, but only to the right ear.
  • Group F - Irradiation was applied seven (7) days after the balloon dilatation.
  • the rabbits were placed in a restraining cage to allow placement of a butterfly needle in the marginal ear vein.
  • Anesthesia was induced with a slow intravenous (IV) solution of ketamine 10 mg/ml and xylazine 2 mg/ml to effect.
  • IV intravenous
  • the depth of anesthesia was monitored by the loss of the righting reflex and jaw tension and controlled with an intermittent IV infusion of the ketamine-xylazine solution.
  • the dorsal side of both ears was shaved and prepped with a 10% betadine solution.
  • the rabbit was placed under a 250 watt heat lamp to induce vasodilation.
  • the central artery of the ear was entered with a 22 gauge over-the-needle catheter (Angiocath, Deseret Medical, Inc., Sandy, Utah). The heat lamp was turned off immediately after achieving vascular access to avoid heat stroke.
  • An IV injection of Heparin 200 units/kg was administered, and a DGW 1.5 millimeter angioplasty balloon catheter (SciMed, Minneapolis, Minnesota) was then advanced into the artery under direct inspection.
  • the catheter was placed and inflated to 6 atmospheres of pressure for ten (10) minutes in the thirty-six (36) rabbits divided into groups A-F above.
  • Applicants had also experimented with a one (1) minute inflation time at 6 atmospheres of pressure to induce injury. However, the one (1) minute inflation time was discarded due to suboptimal injury.
  • the rabbits were euthanized with pentobarbital sodium 300 mg IV, and the ear arteries perfused with 10% buffered formalin for ten (10) minutes under a pressure of 100 millimeters Hg. A full thickness central segment of the ear, containing the central artery and vein and the surrounding tissues, was excised for histological examination.
  • the dilated segment of the rabbit central ear artery was irradiated by a beta irradiation source commonly used to treat ocular pterygium.
  • This irradiation source is a flat sealed Strontium - 90 disc, 8.5 mm in diameter, with a dose-rate of 50 Rads per second in contact mode (Amershon Corp., Arlington Heights, Illinois).
  • the disc is mounted on an applicator shaped handle with a protective plastic shield on the shaft.
  • the source was passed over the artery for 60 seconds in order to deliver a skin dose of 900 Rads of radiation.
  • Each arterial specimen was divided into four sections: two normal sections, proximal and distal to the dilated segment (a, d), and two sections within the dilated segment (b, c).
  • the sections were stained with hematoxylin-eosin for light microscopy.
  • 4-6 representative cross-sections were mounted on a slide and projected into a rear projection screen with a magnification of 150.
  • the edges of the lumen, intima and media were traced manually with an electromagnetic pointer and acquired into a personal computer for area calculation and further analysis.
  • the intima to media area ratio (EMR) measurement was used to compare treatment groups. This area ratio was used instead of absolute values in order to compensate for differences in diameter among the various specimens due either to variation in animal size or variation in vascular distention and pressure during the fixation in vivo.
  • EMR intima to media area ratio
  • This novel experimental model provides a simple, rapid and reproducible method for arterial wall injury.
  • the entire procedure is carried out in a superficial artery, the rabbit central ear artery, using a percutaneous technique.
  • the turn around time, including animal preparation and the induction of anesthesia, is approximately 45 minutes.
  • twelve rabbits can be treated in one (1) day.
  • the use of a fluoroscopic system is obviated.
  • the IMR in the normal, non-dilated, non-irradiated segments was 0.048 ⁇ 0.14 (p ⁇ 0.002) as illustrated in FIG. 10.
  • the IMR for the dilated segment was 0.14 +.0.3, which was not statistically different from the non-dilated segments.
  • FIGS. 12 and 13 there was significant intimal proliferation in all arteries dilated for a period of 10 minutes, with an IMR of 0.28 +. 0.14.
  • the ten (10) minute dilatation period was used to induce injury and subsequent intimal proliferation to study the effect of localized irradiation on restenosis.
  • the IMR in these arteries was 0.61 _ 0.29, and is illustrated in FIG. 11.
  • the IMR was 0.048 ⁇ 0.3 in normal segments and 0.18 ⁇ 0.3 in the dilated segments (p ⁇ 0.1).
  • the IMR was 0.14 ⁇ 0.03 after one (1) minute of inflation and 0.28 ⁇ 0.14 after ten (10) minutes of inflation (p ⁇ 0.002).
  • the IMR in normal arteries treated with irradiation was 0.054 ⁇ 0.11, which is not statistically different from non-irradiated normal arteries.
  • IMR in dilated, irradiated arteries was not statistically different from normal, undilated non-irradiated arteries.
  • applicants discovered that the IMR in dilated, irradiated arteries was dependent upon the time interval between the arterial injury and the irradiation treatment, as illustrated in Table I below and FIGS. 14, 15 and 16.
  • Table I demonstrates that the difference between each of the irradiated groups and the non-irradiated group (IMR, 0.28 ⁇ 0.14) was statistically significant. However, of even more significance was the discovery that the optimal timing for the irradiation treatment was between one (1) and three (3) days after the balloon dilatation. Hence, these studies demonstrate the usefulness of this experimental model and the efficacy and optimal timing of local irradiation following balloon angioplasty to minimize and even prevent restenosis.
  • Example 2 The animal model, experimental design, surgical procedure, histological examination, measurements and statistical analysis are to be used as described above.
  • at least one (1) radiosensitizer can be - ministered in combination with the irradiation to reduce the administered radiation dose without diminishing the radiation effect.
  • radiosensitizing agents for application here; however, bromodioxyuridine can be administered systemically or locally in a dose ranging between 2-10 mg/kg of body weight in combination with irradiation for the prevention of restenosis after angioplasty.
  • a radiosensitizer such as bromodioxyuridine is administered, the irradiation dose may be reduced by 40-60% . This reduction in irradiation dose increases the margin of safety for this particular treatment. In particular, it maintains a constant effect on the target tissue, but spares surrounding tissue from incidental injury.
  • the dose means comprises a heat s____ ⁇ kable polymer catheter tip containing radioactive seeds/particles, as shown in FIGS. 17A-C.
  • an expanded heat shrinkable polymeric tubing 79 is attached to a catheter shaft 80.
  • a plurality of radioactive seeds 81 is located in tubing 79.
  • the number and type of radioactive seeds 81 is selected to correspond to the length of the stenosis to be irradiated and the dose desired.
  • the seeds 81 may be separated by spacers 82, and the spacers 82 may be of a meltable material such as plastic to provide encapsulation.
  • An end plug 83 which may also be meltable, may be provided.
  • the heat shrinkable polymeric tubing 79 encapsulates the seeds 81 and becomes smaller in diameter at each of the spaces 82, as shown in FIG. 17C.
  • the construction shown in FIG. 17C imparts articulation and flexibility to the catheter tip. This embodiment lends itself particularly well to remote automated assembly of the unit.

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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

On décrit un procédé et un dispositif (10) de traitement et post-traitement de la région sténosée (14) d'une artère (12) après réduction de la région par angioplastie ou à l'aide d'autres techniques, en appliquant une dose radioactive (30) à ladite région de l'artère par l'intérmediaire d'un élément de positionnement qui positionne une dose radioactive sur la région réduite. Une irradiation ionisante locale (38) à faible dose est dirigée sur le site d'une intervention intravasculaire afin d'empêcher et/ou de minimiser une prolifération excessive de cellules. La source d'irradiation peut être située à l'extérieur du site ou dans le vaisseau. L'irradiation ionisante locale, à dose faible, peut également être propagée, pendant ou après une intervention, de préférence dans les 72 heures suivant l'intervention, en une simple dose ou en une dose fractionnée, et seule ou en combinaison avec au moins un agent radio-sensibilisant.
PCT/US1992/007447 1991-09-05 1992-09-04 Procede et dispositif de traitement de la restenose WO1993004735A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US07/755,480 1991-09-05
US07/755,480 US5302168A (en) 1991-09-05 1991-09-05 Method and apparatus for restenosis treatment
US75572591A 1991-09-06 1991-09-06
US07/755,725 1991-09-06

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Cited By (64)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994026205A1 (fr) * 1993-05-06 1994-11-24 Kernforschungszentrum Karlsruhe Gmbh Implant vasculaire
WO1995019807A1 (fr) * 1994-01-21 1995-07-27 The Trustees Of Columbia University In The City Of New York Appareil et procede permettant de reduire la restenose apres une intervention arterielle
EP0668088A1 (fr) * 1994-01-24 1995-08-23 Amersham Holdings, Inc. Dispositif et procédé de fabrication d'un ensemble support de sources radioactives
WO1996010436A1 (fr) 1994-09-30 1996-04-11 Liprie Samuel F Catheter de mise en place d'un fil de radiotherapie dans le site de traitement
WO1996017654A1 (fr) * 1994-12-08 1996-06-13 Omnitron International, Inc. Radiotherapie intravasculaire utilisant une source en suspension dans un liquide
WO1996022121A1 (fr) * 1995-01-17 1996-07-25 Christoph Hehrlein Catheter a ballonnet destine a eviter des phenomenes de restenose apres angioplastie et procede de production d'un catheter de type ballonnet
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EP0770258A4 (fr) * 1994-07-12 1997-08-13 Photoelectron Corp Appareil a rayons x appliquant un flux predetermine sur une surface interne d'une cavite du corps
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US5782742A (en) * 1997-01-31 1998-07-21 Cardiovascular Dynamics, Inc. Radiation delivery balloon
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EP1149592A2 (fr) 2000-04-28 2001-10-31 MDS Nordion Inc. Dispositifs à revêtement radioactif
EP0813894B1 (fr) * 1993-07-01 2001-12-05 Schneider (Europe) GmbH Appareils médicaux pour le traitement des vaisseaux sanguins à l'aide de radiation ionisante
SG91308A1 (en) * 1998-05-04 2002-09-17 Novoste Corp Intraluminal radiation treatment system
US6458069B1 (en) 1998-02-19 2002-10-01 Endology, Inc. Multi layer radiation delivery balloon
US6480568B1 (en) 2001-06-19 2002-11-12 Photoelectron Corporation Optically driven therapeutic radiation source
US6480573B1 (en) 2001-12-04 2002-11-12 Photoelectron Corporation Therapeutic radiation source with increased cathode efficiency
US6493419B1 (en) 2001-06-19 2002-12-10 Photoelectron Corporation Optically driven therapeutic radiation source having a spiral-shaped thermionic cathode
US6491619B1 (en) 1997-01-31 2002-12-10 Endologix, Inc Radiation delivery catheters and dosimetry methods
US6721392B1 (en) 2001-12-04 2004-04-13 Carl-Zeiss-Stiftung Optically driven therapeutic radiation source including a non-planar target configuration
US6770058B1 (en) 1997-03-11 2004-08-03 Interventional Therapies, Llc Treatment catheter insert
US6920202B1 (en) 2001-12-04 2005-07-19 Carl-Zeiss-Stiftung Therapeutic radiation source with in situ radiation detecting system
US7066872B2 (en) 1994-10-27 2006-06-27 Best Vascular, Inc. Method and apparatus for treating a desired area in the vascular system of a patient
US7090635B2 (en) 1999-09-22 2006-08-15 Advanced Cardiovascular Systems, Inc. Methods and apparatuses for radiation treatment
US7163504B1 (en) 2000-02-16 2007-01-16 Advanced Cardiovascular Systems, Inc. Multi-lumen fluted balloon radiation centering catheter
US7526068B2 (en) 2001-06-19 2009-04-28 Carl Zeiss Ag X-ray source for materials analysis systems
EP1682213A4 (fr) * 2003-10-10 2009-09-02 Xoft Microtube Inc Applicateur pour un traitement de cavite par rayonnement

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US6283910B1 (en) 1993-05-04 2001-09-04 Anthony J. Bradshaw Method of treating a body vessel or duct with radiation from within the lumen
EP0724467A4 (fr) * 1993-05-04 2000-01-05 Omnitron Int Inc Sonde a source radioactive et appareil et modes de traitement associes
US5674177A (en) * 1993-05-06 1997-10-07 Kernforschungszentrum Karlsruhe Gmbh Vascular implant
WO1994026205A1 (fr) * 1993-05-06 1994-11-24 Kernforschungszentrum Karlsruhe Gmbh Implant vasculaire
EP0813894B1 (fr) * 1993-07-01 2001-12-05 Schneider (Europe) GmbH Appareils médicaux pour le traitement des vaisseaux sanguins à l'aide de radiation ionisante
US6652441B2 (en) 1994-01-21 2003-11-25 The Trustees Of Columbia University In The City Of New York Apparatus and method to treat a disease process in a luminal structure
WO1995019807A1 (fr) * 1994-01-21 1995-07-27 The Trustees Of Columbia University In The City Of New York Appareil et procede permettant de reduire la restenose apres une intervention arterielle
US6217503B1 (en) 1994-01-21 2001-04-17 The Trustees Of Columbia University In The City Of New York Apparatus and method to treat a disease process in a luminal structure
US6045495A (en) * 1994-01-21 2000-04-04 The Trustees Fo Columbia University In The City Of New York Apparatus and method to treat a disease process in a luminal structure
EP0668088A1 (fr) * 1994-01-24 1995-08-23 Amersham Holdings, Inc. Dispositif et procédé de fabrication d'un ensemble support de sources radioactives
US5840064A (en) * 1994-03-31 1998-11-24 United States Surgical Corporation Method and apparatus for treating stenosis or other constriction in a bodily conduit
US5556389A (en) * 1994-03-31 1996-09-17 Liprie; Samuel F. Method and apparatus for treating stenosis or other constriction in a bodily conduit
US6505392B1 (en) 1994-06-08 2003-01-14 Interventional Therapies Llc Process for manufacturing a radioactive source wire for irradiating diseased tissue
US5857956A (en) * 1994-06-08 1999-01-12 United States Surgical Corporation Flexible source wire for localized internal irradiation of tissue
US6876712B1 (en) 1994-06-08 2005-04-05 Interventional Therapies, L.L.C. Flexible source wire for localized internal irradiation of tissue
EP0770258A4 (fr) * 1994-07-12 1997-08-13 Photoelectron Corp Appareil a rayons x appliquant un flux predetermine sur une surface interne d'une cavite du corps
WO1996010436A1 (fr) 1994-09-30 1996-04-11 Liprie Samuel F Catheter de mise en place d'un fil de radiotherapie dans le site de traitement
US7066872B2 (en) 1994-10-27 2006-06-27 Best Vascular, Inc. Method and apparatus for treating a desired area in the vascular system of a patient
US7160238B1 (en) 1994-10-27 2007-01-09 Best Vascular, Inc. Method and apparatus for treating a desired area in the vascular system of a patient
WO1996017654A1 (fr) * 1994-12-08 1996-06-13 Omnitron International, Inc. Radiotherapie intravasculaire utilisant une source en suspension dans un liquide
US5616114A (en) * 1994-12-08 1997-04-01 Neocardia, Llc. Intravascular radiotherapy employing a liquid-suspended source
WO1996022121A1 (fr) * 1995-01-17 1996-07-25 Christoph Hehrlein Catheter a ballonnet destine a eviter des phenomenes de restenose apres angioplastie et procede de production d'un catheter de type ballonnet
US5605530A (en) * 1995-03-23 1997-02-25 Fischell; Robert E. System for safe implantation of radioisotope stents
US5728042A (en) * 1995-06-22 1998-03-17 Schneider (Europe) A.G. Medical appliance for ionizing radiation treatment having radiopaque markers
US5833593A (en) * 1995-11-09 1998-11-10 United States Surgical Corporation Flexible source wire for localized internal irradiation of tissue
US6442822B1 (en) * 1995-11-09 2002-09-03 Interventional Therapies, Llc Flexible source wire for localized internal irradiation of tissue
US5951458A (en) * 1996-02-29 1999-09-14 Scimed Life Systems, Inc. Local application of oxidizing agents to prevent restenosis
US5855546A (en) * 1996-02-29 1999-01-05 Sci-Med Life Systems Perfusion balloon and radioactive wire delivery system
US5916143A (en) * 1996-04-30 1999-06-29 Apple; Marc G. Brachytherapy catheter system
WO1997040889A1 (fr) * 1996-04-30 1997-11-06 Apple Marc G Systeme de catheter a ballonnet contenant un fluide radioactif
US5871436A (en) * 1996-07-19 1999-02-16 Advanced Cardiovascular Systems, Inc. Radiation therapy method and device
US5910101A (en) * 1996-08-29 1999-06-08 Advanced Cardiovascular Systems, Inc. Device for loading and centering a vascular radiation therapy source
US5782740A (en) * 1996-08-29 1998-07-21 Advanced Cardiovascular Systems, Inc. Radiation dose delivery catheter with reinforcing mandrel
US6234952B1 (en) 1996-09-13 2001-05-22 Interventional Therapies Llc Dilatation/centering catheter used for the treatment of stenosis or other construction in a bodily passageway and method thereof
US5947924A (en) * 1996-09-13 1999-09-07 Angiorad, L.L.C. Dilatation/centering catheter used for the treatment of stenosis or other constriction in a bodily passageway and method thereof
EP0829271A2 (fr) 1996-09-13 1998-03-18 Angiorad L.L.C. Cathéter pour dilater et centrer
US6306073B1 (en) 1996-09-26 2001-10-23 The Trustees Of Columbia University In The City Of New York Apparatus and method for treating a disease process in a luminal structure with a radionuclide and chelating agent
US6117064A (en) * 1997-01-06 2000-09-12 Apple; Marc G. Catheter system
US5910102A (en) * 1997-01-10 1999-06-08 Scimed Life Systems, Inc. Conversion of beta radiation to gamma radiation for intravascular radiation therapy
US5873811A (en) * 1997-01-10 1999-02-23 Sci-Med Life Systems Composition containing a radioactive component for treatment of vessel wall
EP0853957A3 (fr) * 1997-01-21 1998-11-25 Robert E. Fischell Cathéter ayant une source radioactive déployable
US6176821B1 (en) 1997-01-31 2001-01-23 Radiance Medical Systems, Inc. Radiation delivery balloon catheter
US6491619B1 (en) 1997-01-31 2002-12-10 Endologix, Inc Radiation delivery catheters and dosimetry methods
US5782742A (en) * 1997-01-31 1998-07-21 Cardiovascular Dynamics, Inc. Radiation delivery balloon
US6699170B1 (en) 1997-01-31 2004-03-02 Endologix, Inc. Radiation delivery balloon catheter
US5865720A (en) * 1997-03-06 1999-02-02 Scimed Life Systems, Inc. Expandable and retrievable radiation delivery system
WO1998039052A1 (fr) * 1997-03-06 1998-09-11 Scimed Life Systems, Inc. Systeme de ballonnet de perfusion et d'apport de fils radioactifs
US6770058B1 (en) 1997-03-11 2004-08-03 Interventional Therapies, Llc Treatment catheter insert
WO1998041298A1 (fr) 1997-03-19 1998-09-24 Lesley Kay Halverson Jeu
EP0865803A3 (fr) * 1997-03-21 1999-04-14 Schneider (Usa) Inc. Dispositif médical auto-expansible
US5993374A (en) * 1997-06-17 1999-11-30 Radiance Medical Systems, Inc. Microcapsules for site-specific delivery
US6273850B1 (en) 1997-10-29 2001-08-14 Medtronic Ave, Inc. Device for positioning a radiation source at a stenosis treatment site
US5851171A (en) * 1997-11-04 1998-12-22 Advanced Cardiovascular Systems, Inc. Catheter assembly for centering a radiation source within a body lumen
US6048299A (en) * 1997-11-07 2000-04-11 Radiance Medical Systems, Inc. Radiation delivery catheter
US6162165A (en) * 1997-12-05 2000-12-19 Cook Incorporated Medical radiation treatment device
US6149574A (en) * 1997-12-19 2000-11-21 Radiance Medical Systems, Inc. Dual catheter radiation delivery system
US6103295A (en) * 1997-12-22 2000-08-15 Mds Nordion Inc. Method of affixing radioisotopes onto the surface of a device
US6676988B2 (en) 1997-12-22 2004-01-13 Mds (Canada) Inc. Radioactively coated devices
US6159140A (en) * 1998-02-17 2000-12-12 Advanced Cardiovascular Systems Radiation shielded catheter for delivering a radioactive source and method of use
WO1999040971A1 (fr) 1998-02-17 1999-08-19 Advanced Cardiovascular Systems, Inc. Catheter d'application de rayonnement avec capacite d'irrigation de sang
US6159139A (en) * 1998-02-17 2000-12-12 Advanced Cardiovascular Systems Inc. Radiation delivery catheter with a spring wire centering mechanism
US6458069B1 (en) 1998-02-19 2002-10-01 Endology, Inc. Multi layer radiation delivery balloon
US6685618B2 (en) 1998-02-19 2004-02-03 Endologix, Inc. Method for delivering radiation to an intraluminal site in the body
US6287249B1 (en) 1998-02-19 2001-09-11 Radiance Medical Systems, Inc. Thin film radiation source
WO1999056828A1 (fr) * 1998-04-30 1999-11-11 Christoph Hehrlein Catheter ou tuteur vasculaire avec sensibilisateur aux rayonnements, et son procede de production
SG91308A1 (en) * 1998-05-04 2002-09-17 Novoste Corp Intraluminal radiation treatment system
US6074339A (en) * 1998-05-07 2000-06-13 Medtronic Ave, Inc. Expandable braid device and method for radiation treatment
EP0997163A1 (fr) 1998-10-30 2000-05-03 Acrostak Co Méthode de production d'un corps bobiné destiné à l'irradiation radioactive
US6415009B1 (en) 1998-10-30 2002-07-02 Acrostak Co. Method for producing a coiled body for irradiating radioactive radiation
WO2000074778A1 (fr) 1999-06-04 2000-12-14 Interventional Therapies, L.L.C. Systeme et procede pour administrer un traitement medical sur un site de traitement
US7090635B2 (en) 1999-09-22 2006-08-15 Advanced Cardiovascular Systems, Inc. Methods and apparatuses for radiation treatment
US7163504B1 (en) 2000-02-16 2007-01-16 Advanced Cardiovascular Systems, Inc. Multi-lumen fluted balloon radiation centering catheter
EP1149592A2 (fr) 2000-04-28 2001-10-31 MDS Nordion Inc. Dispositifs à revêtement radioactif
EP1733745A2 (fr) 2000-04-28 2006-12-20 MDS (Canada) Inc. Dispositifs à revêtement radioactif
US6480568B1 (en) 2001-06-19 2002-11-12 Photoelectron Corporation Optically driven therapeutic radiation source
US6493419B1 (en) 2001-06-19 2002-12-10 Photoelectron Corporation Optically driven therapeutic radiation source having a spiral-shaped thermionic cathode
US7526068B2 (en) 2001-06-19 2009-04-28 Carl Zeiss Ag X-ray source for materials analysis systems
USRE41741E1 (en) 2001-06-19 2010-09-21 Carl Zeiss Ag Optically driven therapeutic radiation source having a spiral shaped thermionic cathode
US6920202B1 (en) 2001-12-04 2005-07-19 Carl-Zeiss-Stiftung Therapeutic radiation source with in situ radiation detecting system
US6721392B1 (en) 2001-12-04 2004-04-13 Carl-Zeiss-Stiftung Optically driven therapeutic radiation source including a non-planar target configuration
US6480573B1 (en) 2001-12-04 2002-11-12 Photoelectron Corporation Therapeutic radiation source with increased cathode efficiency
EP1682213A4 (fr) * 2003-10-10 2009-09-02 Xoft Microtube Inc Applicateur pour un traitement de cavite par rayonnement

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