Radioactive catheter
First Claim
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1. A device suitable for endoluminal radiation treatment of a portion of a coronary artery in humans, the device comprising:
- (a) an elongated, flexible carrier having a proximal section and a distal section; and
(b) radioactive means positioned in a radioactive segment of the distal section of the carrier, the radioactive means providing radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive portion,wherein the carrier is sized and has sufficient stiffness and flexibility to navigate a human coronary artery so that the radioactive segment can be placed in a selected portion of a human coronary artery, the radioactive means when so placed providing sufficient radiation in less than 30 minutes to prevent restenosis in the selected portion after angioplasty.
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Abstract
A method for preventing restenosis after angioplasty comprises internally radiating the treated portion of the lumen to prevent restenosis of the enlarged lumen portion. A device useful for radiating the treated portion comprises an elongated flexible catheter with radioactive means located in a distal section of the carrier. Stiffening elements are located along the length of the catheter to enable the catheter to be pushed through the tortuous segments of coronary or peripheral vasculature without crimping.
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Citations
41 Claims
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1. A device suitable for endoluminal radiation treatment of a portion of a coronary artery in humans, the device comprising:
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(a) an elongated, flexible carrier having a proximal section and a distal section; and (b) radioactive means positioned in a radioactive segment of the distal section of the carrier, the radioactive means providing radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive portion, wherein the carrier is sized and has sufficient stiffness and flexibility to navigate a human coronary artery so that the radioactive segment can be placed in a selected portion of a human coronary artery, the radioactive means when so placed providing sufficient radiation in less than 30 minutes to prevent restenosis in the selected portion after angioplasty. - View Dependent Claims (2, 3, 4, 6, 8, 40, 41)
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5. The device suitable for treatment of a portion of a lumen in mammals, the device comprising:
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(a) an elongated, flexible carrier having a proximal section, an intermediate section, and a distal section; and (b) at least three separate stiffening elements immovably located along the length of the carrier so that the proximal section of the carrier is the stiffest section of the carrier and the distal section of the carrier is the most flexible section of the carrier so that the intermediate section of the carrier has a stiffness intermediate the stiffness of the proximal section and the stiffness of the distal section, so that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the carrier; and (c) radioactive means positioned in a radioactive segment of the distal section of the carrier, the radioactive means providing radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive segment, wherein the carrier is sized and has sufficient stiffness and flexibility to navigate a human coronary artery so that the radioactive portion can be placed in a selected portion of a human coronary artery, the radioactive means when so placed providing sufficient radiation in less than 30 minutes to prevent restenosis in the selected portion after angioplasty. - View Dependent Claims (7, 9, 10)
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11. A device suitable for endoluminal radiation treatment of a portion of lumen in a mammal, the device comprising:
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(a) a hollow, elongated flexible tube having an axial passage, the tube having a proximal section, a distal section, and an intermediate section between the proximal and distal sections, the distal section including a distal end, the tube having a substantially constant outer diameter, a substantially constant inner diameter, and being composed of a material whose composition does not vary along the length of the carrier; (b) radioactive means positioned in a radioactive segment of the distal section of the tube proximate to the distal end, the radioactive means providing sufficient radiation, in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive segment, that when the radioactive portion is placed in the portion of the lumen for an exposure time less than 30 minutes, restenosis in the portion of the lumen is prevents; and (c) at least three separate stiffening elements immovably and serially located within the tube and extending longitudinally along the axial passage of the tube for differentially stiffening the proximal, intermediate, and distal sections of the tube, the stiffening elements being selected so that the proximal section of the tube is the stiffest section of the tube, the distal section of the tube is the most flexible section of the tube, and the intermediate section of the tube has a stiffness intermediate the stiffness of the proximal section and the stiffness of the distal section so that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the tube. - View Dependent Claims (12, 13, 14, 15, 16, 18, 19, 22, 23)
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17. A device for endoluminal radiation treatment of a portion of a lumen in human beings, the device comprising:
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(a) a hollow elongated flexible tube of outer diameter of less than about 1 mm, the tube having a proximal section, a distal section and an intermediate section between the proximal and distal sections, the distal section including a distal end; (b) a plurality of radioactive beads positioned in a radioactive segment within the distal section of the tube proximate to the distal end of the tube, the radioactive beads providing sufficient radiation in an amount from 0.01 to 100,000 millicuries per centimeter length of the radioactive segment, that when the radioactive segment is placed in a selected portion of a human lumen for less than 30 minutes, restenosis in the selected portion of lumen is prevented; (c) at least three separate stiffening elements immovably and serially located within the tube and extending longitudinally along the axial passage of the tube for differentially stiffening sections of the tube, the stiffening elements comprising a proximal stiffening element in a proximal section of the tube, a distal stiffening element in a distal section of the tube, and an intermediate stiffening element in an intermediate section of the tube between the distal and proximal sections, wherein the proximal stiffening element is the stiffest stiffening element, the distal stiffening element is the least stiff stiffening element, and the intermediate stiffening element has a stiffness intermediate the stiffness of the proximal and distal stiffening elements; (d) means for maintaining radioactive beads spaced apart from each other so that the radioactive segment of the tube is flexible; and wherein the distal stiffening element is sufficiently flexible and the beads are sufficiently spaced apart from each other that the distal section can be advanced in transluminal movement to navigate tortuous turns in the lumen by pushing on the proximal section without crimping the tube and that the radioactive segment of the tube can navigate tortuous turns in the lumen. - View Dependent Claims (20, 21)
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24. A method for preventing stenosis of a selected portion of a lumen in a mammal comprising the steps of:
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(a) introducing a flexible, elongated carrier having a radioactive segment carrying radioactive elements into the lumen so that the radioactive elements are in the selected section of the lumen; (b) irradiating the selected section of lumen with the radioactive elements for no more than about 45 minutes, the amount of radiation delivered to the selected section of lumen being at least about 25 rads per cm length of the selected section of the lumen; and (c) withdrawing the carrier. - View Dependent Claims (25, 26, 27, 28)
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29. A method for enlarging the luminal cross-section of a selected portion of a mammalian lumen and preventing stenosis of the enlarged portion, the method comprising the steps of:
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(a) enlarging the selected portion of the lumen with an endoluminal treatment apparatus having an outer diameter sufficiently small that the apparatus fits in the lumen; (b) inserting a device having a radioactive segment comprising radioactive means into the enlarged portion of the lumen so that the radioactive means is proximate to the enlarged portion of the lumen; (c) leaving the device in the lumen with the radioactive means proximate to the enlarged portion of the lumen for internally radiating the enlarged portion of the lumen with sufficient radioactivity in an amount from about 25 to about 2500 rads per centimeter length of the radioactive segment to prevent stenosis of the enlarged lumen portion; and (d) thereafter withdrawing the device from the lumen. - View Dependent Claims (30, 32, 33, 34, 35, 36, 37, 38, 39)
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31. The method of claim 31 wherein the lumen comprises a section of the vasculature of a human.
Specification