Valvulotome with a cutting edge
First Claim
1. A valvulotome device for removing valve leaflets of a body vessel comprising a catheter having a proximal end and a distal tip, the catheter including an inner tubular member extending axially from the distal tip, the catheter being disposed around a longitudinal axis,a tubular member having a first portion including two valvulotome cutting arms joined together at a common proximal end and a second portion coaxially disposed about the inner tubular member,the valvulotome cutting arms being moveable from a radially compact delivery configuration to a radially expanded configuration, the valvulotome cutting arms being positioned between the proximal end and the distal tip of the catheter in both the radially compact delivery configuration and the radially expanded configuration;
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Accused Products
Abstract
Valvulotome devices comprising a cutting edge are provided. Some valvulotome devices incisably engage a venous valve leaflet within a body vessel while at least a portion of the cutting edge is oriented substantially parallel to the longitudinal axis of the valvulotome device. Valvulotome devices are preferably configured to slidably engage a venous valve leaflet upon translation of the valvulotome device along the longitudinal axis of a body vessel. A valvulotome device can further comprise one or more valvulotome arms of variable lengths and dimensions. In some embodiments, the valvulotome device can be self expanding. Embodiments of the invention also provide delivery systems comprising a valvulotome device. The present invention also provides for methods of using a valvulotome device. Kits comprising a valvulotome device are also provided.
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Citations
21 Claims
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1. A valvulotome device for removing valve leaflets of a body vessel comprising a catheter having a proximal end and a distal tip, the catheter including an inner tubular member extending axially from the distal tip, the catheter being disposed around a longitudinal axis,
a tubular member having a first portion including two valvulotome cutting arms joined together at a common proximal end and a second portion coaxially disposed about the inner tubular member, the valvulotome cutting arms being moveable from a radially compact delivery configuration to a radially expanded configuration, the valvulotome cutting arms being positioned between the proximal end and the distal tip of the catheter in both the radially compact delivery configuration and the radially expanded configuration; - and
the valvulotome cutting arms each having a notch facing toward the longitudinal axis and including a cutting edge at least partially enclosed within the notch, the valvulotome cutting arms including a first notch on a first arm oriented in a first direction and a second notch on a second arm oriented in a second direction oppositely disposed from the first direction. - View Dependent Claims (2, 3, 4, 5)
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6. A self-centering valvulotome device for removing valve leaflets of a body vessel, comprising a plurality of arms radially arranged around a catheter having a longitudinal axis extending between a proximal end and a distal tip;
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the catheter including an inner tubular member extending axially from the distal tip; the plurality arms being movable from a radially compact delivery configuration and a radially expanded configuration, the arms being positioned between the proximal end and the distal tip of the catheter, the plurality of arms having a body with a U-shaped cross-section extending between a proximal end and a distal end, the body having a curved side facing radially outward to contact the wall of the body vessel and an interior sized to fit around the inner tubular member; the plurality of arms including at least two cutting arms each having a notch including a cutting edge at least partially enclosed within the notch; and the plurality of arms including at least one arm without a cutting edge. - View Dependent Claims (7, 8)
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9. A valvulotome device for removing valve leaflets of a body vessel, comprising a catheter having a proximal end and a distal tip, the catheter including an inner tubular member defining a guide wire conduit and extending axially from the distal tip and an outer sheath coaxially disposed radially outward from the inner tubular member such that an annular space is defined therebetween, where the outer sheath has a delivery position and a deployment position, the catheter being disposed around a longitudinal axis,
a plurality of arms radially arrayed in a symmetric fashion around the inner tubular member between the proximal end and the distal tip, the plurality of arms including at least one cutting arm having a notch with a cutting edge, and at least one centering arm without a cutting edge, the plurality of arms being radially self-expandable from a radially compact delivery configuration to a radially expanded configuration, wherein the plurality of arms are retained in the radially compact delivery configuration within the annular space when the outer sheath is in the delivery position, and the valvulotome arms are radially expanded to the radially expanded configuration when the outer sheath is in the deployment position, and wherein the cutting edge of the notch has a substantial portion facing away from an adjacent wall of said body vessel wall toward the longitudinal axis.
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11. A method of disabling a venous valve within a vein comprising the steps of:
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providing a valvulotome device, the valvulotome device comprising a catheter disposed about a longitudinal axis having a proximal end and a distal tip, the catheter including an inner tubular member extending axially from the distal tip and an outer sheath coaxially disposed radially outward from the inner tubular member such that an annular space is defined therebetween, the outer sheath having a delivery position and a deployment position, and a plurality of arms arrayed around the inner tubular member, the plurality of arms including at least two cutting arms each having a notch including a cutting edge, the plurality of arms being moveable from a radially compact delivery configuration to a radially expanded configuration, where in the radially compact delivery configuration the plurality of arms are retained within the annular space when the outer sheath is in the delivery position, and the plurality of arms are radially expanded to the radially expanded configuration when the outer sheath is in the deployment position; inserting the valvulotome device, with the outer sheath in the delivery position, into said vein; advancing the valvulotome device to a point of treatment within said vein; retracting the outer sheath from the delivery position to the deployment position to radially expand the arms from the radially compact delivery configuration to the radially expanded configuration; and translating the valvulotome device longitudinally within the vein to slidably engage a venous valve leaflet within the notch of at least one of the two cutting arms.
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12. A valvulotome device for removing valve leaflets from within a body vessel, comprising:
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a catheter disposed around a longitudinal axis having a proximal end and a distal tip, the catheter including an inner tubular member extending axially from the distal tip, and a plurality of arms arrayed in a radially symmetric fashion around the inner tubular member between the proximal end and the distal tip, the plurality of arms including at least two cutting arms, each cutting arm having a distal portion with a notch disposed therein facing toward the longitudinal axis, wherein the notch includes a cutting edge having a substantial portion facing toward the longitudinal axis and away from an adjacent body vessel wall. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A valvulotome device for removing valve leaflets of a body vessel, comprising:
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a catheter disposed about a longitudinal axis having a proximal end and a distal tip, the catheter including an inner tubular member defining a guide wire conduit and extending axially from the distal tip and an outer sheath coaxially disposed radially outward from the inner tubular member such that an annular space is defined therebetween; two cutting arms joined together at a common proximal end contacted with the inner tubular member, each cutting arm distally extending radially outward from the inner tubular member between said common proximal end and the distal tip, each cutting arm being positionable within the annular space, each cutting arm further comprising a body with a curved side, where the curved side is oriented to face radially outward to contact a wall of said body vessel, each cutting arm having a distal portion with a notch disposed therein facing opposite the curved side of the body toward the longitudinal axis, wherein the notch comprises a notch perimeter including a cutting edge and a leaflet engaging probe member disposed across the notch from the cutting edge to enclose the cutting edge such that said body vessel wall is protected from contact with the cutting edge; and two centering valvulotome arms without a cutting edge joined together at a common proximal end contacted with the inner tubular member, each centering arm distally extending radially outward from the inner tubular member between said common proximal end and the distal tip. - View Dependent Claims (19, 20, 21)
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Specification