Method and apparatus for treating a desired area in the vascular system of a patient
First Claim
1. An apparatus for treating a selected area of the vascular system of a patient comprising:
- at least one elongated flexible tube including a proximal end and a distal end for positioning at the selected area of the vascular system and defining first, second, third, and fourth lumens, said first, second, and third lumens extending in generally parallel relationship between said proximal and distal ends of said tube, said second and third lumens being in fluid-tight communication at said distal end of said tube, said fourth lumen being open at said distal end of said tube for receiving a guidewire, and a flexible balloon membrane carried at said distal end of said tube, said balloon membrane being in fluid communication with said first lumen for inflation when pressurized fluid is introduced through said first lumen.
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Accused Products
Abstract
Apparatus and method are described for delivery of a treating element, such as a radiation source, through a catheter to a desired site in the vascular system of a patient, such as a coronary artery, for inhibiting the formation of scar tissue such as may occur in restenosis following balloon angioplasty. The apparatus includes an elongated flexible catheter tube having proximal and distal end portions, with a lumen extending therebetween, and a diameter sufficiently small for insertion in to a patient'"'"'s vascular system. One or more treating elements, such as a capsule or pellet containing radioactive material, is positionable within the lumen and movable between the proximal and distal end portions under the force of liquid flowing through the lumen. A method for using such apparatus, including a method for using such apparatus simultaneously with a balloon angioplasty procedure, is disclosed.
213 Citations
27 Claims
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1. An apparatus for treating a selected area of the vascular system of a patient comprising:
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at least one elongated flexible tube including a proximal end and a distal end for positioning at the selected area of the vascular system and defining first, second, third, and fourth lumens, said first, second, and third lumens extending in generally parallel relationship between said proximal and distal ends of said tube, said second and third lumens being in fluid-tight communication at said distal end of said tube, said fourth lumen being open at said distal end of said tube for receiving a guidewire, and a flexible balloon membrane carried at said distal end of said tube, said balloon membrane being in fluid communication with said first lumen for inflation when pressurized fluid is introduced through said first lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for treating a selected area of a coronary artery in a human patient that is to be subjected to an opening procedure, said method comprising:
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a) providing at least one elongated tube having a proximal end and a distal end and defining first, second, third, and fourth lumens, said first, second, and third lumens extending between said proximal and distal ends of said tube, said second and third lumens being in fluid-tight communication at said distal end of said tube, said fourth lumen being open at said distal end of said tube for receiving a guidewire, and a flexible balloon membrane carried at said distal end of said tube, said balloon membrane being in fluid communication with said first lumen for inflation when pressurized fluid is introduced through said first lumen, b) providing at least one treating element slidably receivable in said second lumen and movable from said proximal end of said tube to said distal end when fluid is directed through said second lumen and movable from said distal end of said tube to said proximal end when fluid is directed into said third lumen, c) advancing said distal end of said fourth lumen through the vascular system of the patient to the selected area by advancing said fourth lumen over a guidewire that extends to the selected area, d) inflating said balloon by directing fluid into said first lumen, e) advancing said treating element to the selected area through said second lumen by directing a fluid through said second and third lumens in a forward direction, and f) allowing said treating element to remain in the selected area for a therapeutically effective amount of time. - View Dependent Claims (9, 10, 11)
a) retrieving said treating element from the selected area and returning it to said proximal end of said tube by directing fluid flow through said third and second lumens in a reverse direction, and b) withdrawing said tube from the artery of the patient.
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10. The method of claim 8 further comprising providing said at least one elongated tube wherein said tube comprises four conjoined coaxial tubes each having a proximal and a distal end, with the spaces between said coaxial tubes defining said first, second, and third lumens, and the coaxial tube that is innermost having a lumen comprising said fourth lumen.
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11. The method of claim 8 further comprising:
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a) providing a second tube having a proximal end and a distal end substantially coextensive with said at least one tube, wherein said at least one tube defines said first lumen and further defines a fifth lumen sized to receive said second tube, and said second tube defines said second, third, and fourth lumens, b) advancing said second tube to the selected area within said fifth lumen of at least one tube after said balloon has been inflated.
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12. An apparatus for treating a selected area of the vascular system of a patient comprising:
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an elongated tube having a proximal end portion, a distal end portion opposite said proximal end portion and first and second lumens extending therebetween;
a flexible balloon membrane carried at said distal end portion of said elongated tube, said balloon membrane being in communication with said first lumen for inflation when pressurized fluid is introduced through said first lumen; and
a radioactive treating element carried within said second lumen and moveable between said proximal and distal end portions by means of pressurized fluid introduced through said second lumen.
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13. An apparatus for treating a selected area of the vascular system of a patient comprising:
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an elongated flexible tube including a proximal end and a distal end for positioning at the selected area of the vascular system and defining first, second and third lumens, said first, second and third lumens extending in generally parallel relationship between said proximal and distal ends of said tube, said first lumen being open at said distal end of said tube for receiving a guidewire, said second and third lumens being in fluid-tight communication at said distal end of said tube, and a flexible balloon membrane carried at said distal end of said tube, said balloon membrane being in fluid communication with one of said second and third lumens for inflation when pressurized fluid is introduced through said second and third lumens;
said second lumen having a diameter sufficiently large between said proximal and distal ends of said tube to permit slidable passage of at least one treating element between said proximal and distal ends, whereby said at least one treating element may be moved between said proximal and distal ends of said tube through said second lumen under the force of pressurized fluid flowing through said second and third lumens. - View Dependent Claims (14, 15, 16, 17, 18)
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19. A method for treating a selected area of a coronary artery in a human patient that is to be subjected to an opening procedure, said method comprising:
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a) providing an elongated flexible tube having a proximal end and a distal end and defining first, second and third lumens, said first, second and third lumens extending between said proximal and distal ends of said tube, said first lumen being open at said distal end of said tube for receiving a guidewire, said second and third lumens being in fluid-tight communication at said distal end of said tube, and a flexible balloon membrane carried at said distal end of said tube, said balloon membrane being in fluid communication with one of said second and third lumens for inflation when pressurized fluid is introduced through said second and third lumens, b) providing at least one treating element slidably receivable in said second lumen and movable from said proximal end of said tube to said distal end of said tube when pressurized fluid is directed through said second lumen and movable from said distal end of said tube to said proximal end of said tube when pressurized fluid is directed into said third lumen, c) advancing said distal end of said tube through the vascular system of the patient to the selected area by advancing said first lumen over a guidewire that extends to the selected area, d) inflating said balloon by directing pressurized fluid into said second and third lumens, e) advancing said treating element to the selected area through said second lumen by directing pressurized fluid through said second and third lumens in a forward direction, and f) allowing said treating element to remain in the selected area for a therapeutically effective amount of time. - View Dependent Claims (20, 21, 22)
a) retrieving said treating element from the selected area and returning it to said proximal end of said tube by directing pressurized fluid flow through said third and second lumens in a reverse direction, and b) withdrawing said tube from the artery of the patient.
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21. The method of claim 19 further comprising providing said elongated tube wherein said tube comprises three conjoined coaxial tubes each having a proximal and a distal end, with the spaces between said coaxial tubes defining said second and third lumens, and the innermost coaxial tube having a lumen comprising said first lumen.
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22. The method of claim 19 further comprising providing said elongated tube wherein said tube comprises two adjacent inner tubes contained within an outer tube, said inner tubes defining said first and second lumens and said outer tube defining said third lumen.
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23. An apparatus for treating a selected area of the vascular system of a patient by means of at least one treating element transported to the selected area by pressurized fluid, the apparatus comprising:
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inner, outer, and intermediate spaced-apart, elongated, flexible coaxial tubes, each tube having a proximal end and a distal end for positioning at the selected area of the vascular system;
the coaxial tubes defining a first lumen interior of the inner tube, a second lumen interior of the intermediate tube and exterior of the inner tube, and a third lumen interior of the outer tube and exterior of the intermediate tube;
the first lumen being open at its distal end for receiving a guidewire and one of said second and third lumens being adapted to transport a treating element between the proximal and distal ends of the tube by pressurized fluid; and
a flexible balloon membrane carried at the distal ends of the coaxial tubes, the balloon membrane being in fluid communication with the third lumen for inflation by the pressurized fluid used for transporting the treating element. - View Dependent Claims (24, 25, 26)
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27. An apparatus for treating a selected area of the vascular system of a patient by means of at least one treating element transported to the selected area by pressurized fluid, the apparatus comprising:
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a first elongated flexible tube having a proximal end and a distal end and defining a first lumen, the distal end of the first lumen being open for receiving a guidewire;
a second elongated flexible tube having a proximal end and a distal end and defining a second lumen, the second tube being in parallel relationship with the first tube and adapted to transport a treating element between the proximal end and distal end by pressurized fluid;
a third, outer elongated, flexible tube having a proximal end and a distal end and containing the first and second tubes, a third lumen being defined interior of the outer tube and exterior of the first and second tubes, the second lumen and the third lumen being in fluid communication to permit transport of the treating element between the proximal and distal ends of the second tube; and
a flexible balloon membrane carried at the distal ends of the tubes, the balloon membrane being in fluid communication with the third lumen for inflation by the pressurized fluid used for transporting the treating element.
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Specification