Catheter atherotome
First Claim
1. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
- (a) an elongate tubular outer sheath having respective proximal and distal ends;
(b) an elongate inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath;
(c) a plurality of elongate blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member;
(d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said blades into a radially outwardly bowed arcuate configuration; and
(e) at least some of said blades defining respective sharp edges, at least a portion of each said sharp edge extending alongside said inner member and facing generally more toward said proximal ends than toward said distal ends of said outer sheath and said inner member, the ones of said blades arranged over approximately one-half the circumference of said outer sheath and inner member including said sharp edges while the remainder of said blades are free from said sharp edges.
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Accused Products
Abstract
A catheter atherotome and method for its use for performing partial atherectomy in an artery and thereby enlarging the lumen effectively available for blood flow through the artery. Several blades are mounted at a distal end of a catheter, in a helical basket configuration and spaced angularly apart from one another about the associated ends of two concentric sheaths in such a way that longitudinal and rotary relative movement of the sheaths selectively bows the blades arcuately outwardly into a cutting position or draws the blades flat into alignment with the sheaths. The blades have sharpened cutting edges extending helically and directed toward the catheter'"'"'s proximal end when the blades are bowed. Partial removal of an atheroma is effected by manually pulling the basket knife past an atheroma with the basket blades in their outwardly bowed cutting positions, with the speed, force, and amount of expansion of the blades determined by the operator. Removal of cut-away pieces of atherosclerotic plaque material is accomplished either by pull-back of a balloon embolectomy catheter or by use of a latex membrane enshrouding the spiral wire blades to trap the shavings within the membrane.
277 Citations
42 Claims
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1. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said blades into a radially outwardly bowed arcuate configuration; and (e) at least some of said blades defining respective sharp edges, at least a portion of each said sharp edge extending alongside said inner member and facing generally more toward said proximal ends than toward said distal ends of said outer sheath and said inner member, the ones of said blades arranged over approximately one-half the circumference of said outer sheath and inner member including said sharp edges while the remainder of said blades are free from said sharp edges.
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2. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said blades into a radially outwardly bowed arcuate configuration; and (e) at least some of said blades defining respective knife-like sharpened edges, at least a portion of each said knife-like sharpened edge extending alongside said inner member and being oriented more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said blades are in said outwardly bowed arcuate configuration, so as to engage plaque associated with an inner wall of an artery cuttingly as said catheter atherotome is moved within said artery in a proximal direction, without engaging said interior wall of said artery cuttingly as said catheter atherotome is moved within said artery in a distal direction, each of said blades defining a knife-like sharpened edge including a middle portion defining said knife-like sharpened edge and a pair of intermediate portions adjacent said middle portion, said intermediate portions being sufficiently more flexible than said middle portion that said middle portion substantially retains its original shape during flexing of said blades into said radially outwardly bowed arcuate configuration. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate inner member disposed within said outer sheath, said inner member having respective proximal and distal ends and defining a central longitudinal axis and said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said blades into a radially outwardly bowed arcuate configuration; (e) at least some of said blades defining respective sharp edges, at least a portion of each said sharp edge extending alongside said inner member and facing generally more toward said proximal ends than toward said distal ends of said outer sheath and said inner member; (f) means for preventing at least one of said ends of each of said blades from rotating with respect to said outer sheath and said inner member about an axis extending generally parallel with said central longitudinal axis, while permitting a terminal portion of each of said blades to rotate about an axis extending substantially perpendicular to said central longitudinal axis, between a position in which said terminal portion extends generally parallel with said longitudinal axis and a position in which said terminal portion extends away from said longitudinal axis at an acute angle and said middle portion of said blade is displaced radially away from said longitudinal axis; (g) fin means included in at least one of said terminal portions of each of said blades, for defining a bore, each said bore defining an axis of rotation of a respective one of said terminal portions relative to a respective one of said inner member and said outer sheath to which said respective one of said terminal portions is attached; and (h) mounting means for attachment of said blades to said inner member and said outer sheath, said mounting means defining radial slot means for cooperating with said fin means of each of said blades, so as substantially to prevent said terminal portions of each of said blades from rotating about an axis parallel with said central longitudinal axis of said inner member. - View Dependent Claims (14)
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15. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate flexible tubular outer sheath having respective proximal and distal ends; (b) an elongate flexible tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate knife blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) at least some of said knife blades defining respective knife-like sharp edges, at least a portion of each said knife-like sharp edge extending alongside said inner member and facing more toward said proximal ends than toward said distal ends of said outer sheath and said inner member, said knife blades defining a diameter of said catheter atherotome and each knife blade having a pitch with respect to said inner member; (e) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said knife blades into a radially outwardly bowed arcuate configuration of increased diameter; and (f) means for rotating said inner member with respect to said outer sheath so as to control the pitch of said knife blades.
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16. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate flexible tubular outer sheath having respective proximal and distal ends; (b) an elongate flexible tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate knife blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) at least some of said knife blades defining respective knife-like sharp edges, at least a portion of each said knife-like sharp edge extending alongside said inner member and facing more toward said proximal ends than toward said distal ends of said outer sheath and said inner member, said knife blades defining a diameter of said catheter atherotome and each knife blade having a pitch with respect to said inner member; (e) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said knife blades into a radially outwardly bowed arcuate configuration of increased diameter; and (f) means for controlling said pitch and said diameter while using said catheter atherotome.
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17. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said blades into a radially outwardly bowed arcuate configuration; and (e) at least some of said blades defining respective sharp edges, at least a portion of each said sharp edge extending alongside said inner member and being oriented more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said blades are in said outwardly bowed arcuate configuration, so as to engage plaque associated with an inner wall of an artery cuttingly as said catheter atherotome is moved within said artery in a proximal direction, without engaging said interior wall of said artery cuttingly as said catheter atherotome is moved within said artery in a distal direction and at least one of said sharp edges having respective opposite first and second ends, said first and second ends thereof being angularly separated from each other by a controllably variable angle about said inner member when said blades are in said outwardly bowed arcuate configuration.
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18. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said blades into a radially outwardly bowed arcuate configuration; and (e) at least some of said blades defining respective sharp edges, at least a portion of each said sharp edge extending alongside said inner member and being oriented more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said blades are in said outwardly bowed arcuate configuration, so as to engage plaque associated with an inner wall of an artery cuttingly as said catheter atherotome is moved within said artery in a proximal direction, without engaging said interior wall of said artery cuttingly as said catheter atherotome is moved within said artery in a distal direction and some of said blades being free from sharp edges and being located opposite said blades defining sharp edges, so as to contact an interior surface of an artery and distend said artery when said blades are in said radially outwardly bowed arcuate configuration.
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19. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate knife blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said knife blades into a radially outwardly bowed arcuate configuration defining a cutting diameter; and (e) said knife blades having sharpened front edges and blunt back margins, each of said knife blades including a middle portion, defining said sharpened front edge, and a pair of opposite intermediate portions, said intermediate portions being sufficiently more flexible than said middle portion that said middle portion substantially retains its original shape as said knife blade flexes into said outwardly bowed configuration and said sharpened front edges overlapping one another about said outer sheath and being oriented more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said knife blades are at any of a plurality of predetermined cutting diameters, providing complete circumferential coverage of said artery so as to cut through a stenotic lesion as said catheter atherotome is moved in the proximal direction in said artery. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27)
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28. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate knife blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said knife blades into a radially outwardly bowed arcuate configuration defining a cutting diameter; and (e) said knife blades having sharpened front edges and blunt back margins, and having respective opposite first and second ends, said first and second ends thereof being angularly separated from each other by a controllably variable angle about said inner member when said knife blades are in said outwardly bowed arcuate configuration and said sharpened front edges overlapping one another about said outer sheath and being oriented more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said knife blades are at any of a plurality of predetermined cutting diameters, providing complete circumferential coverage of said artery so as to cut through a stenotic lesion as said catheter atherotome is moved in the proximal direction in said artery.
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29. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate knife blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said knife blades into a radially outwardly bowed arcuate configuration defining a cutting diameter; and (e) said knife blades having sharpened front edges and blunt back margins, said means for moving said inner member including means for rotating said inner member with respect to said outer sheath, so as to alter the inclination of said sharpened front edges with respect to said outer sheath and thus with respect to a stenotic lesion to be cut by said catheter atherotome and said sharpened front edges overlapping one another about said outer sheath and being oriented more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said knife blades are at any of a plurality of predetermined cutting diameters, providing complete circumferential coverage of said artery so as to cut through a stenotic lesion as said catheter atherotome is moved in the proximal direction in said artery.
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30. A catheter atherotome for use in surgical removal of plaque from the interior wall of an artery, comprising:
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(a) an elongate tubular outer sheath having respective proximal and distal ends; (b) an elongate tubular inner member disposed within said outer sheath and having respective proximal and distal ends, said distal end of said inner member extending beyond said distal end of said outer sheath; (c) a plurality of elongate knife blades each having a proximal end interconnected with said outer sheath and a distal end interconnected with said inner member; (d) means for moving said inner member with respect to said outer sheath so as to retract said distal end of said inner member toward said distal end of said outer sheath and flex said knife blades into a radially outwardly bowed arcuate configuration; and (e) at least some of said knife blades defining respective knife-like sharpened edges, at least a portion of each said knife-like sharpened edge extending alongside said inner member and facing generally more toward said proximal ends than toward said distal ends of said outer sheath and said inner member when said knife blades are in said outwardly bowed arcuate configuration, some of said knife blades being free from sharpened edges and being located opposite respective ones of said knife blades defining knife-like sharpened edges, so as to contact an interior surface of an artery and support said knife-like sharpened edges with respect to said interior surface of said artery when said knife blades are in said radially outwardly bowed arcuate configuration. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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Specification