Apparatus and methods for dilating vessels and hollow-body organs
First Claim
1. Apparatus for dilating a vessel or organ comprising:
- a catheter shaft having proximal and distal ends;
a balloon disposed on the distal end of the catheter shaft;
a sheath disposed surrounding the catheter shaft, the sheath having proximal and distal ends; and
a mesh portion attached to the distal end of the sheath and disposed surrounding the balloon for sliding movement relative thereto, the mesh portion comprising a non-compliant material having a first state wherein the mesh portion has a first length and an insertion diameter and a second state wherein the mesh portion has second length, shorter than the first length, and a selected predetermined expanded diameter; and
a retractor element disposed on the proximal end of the sheath for retracting the mesh portion to the first state,wherein, when the balloon is fully inflated, the mesh portion is in the second state and attains the selected predetermined expanded diameter, the mesh portion constraining the balloon from further expansion.
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Accused Products
Abstract
Apparatus and methods for dilating a vessel or organ, especially a larger diameter vessel or organ, are provided using a catheter having a balloon element is disposed within a sheath having an expandable but non-compliant mesh region covering the balloon element. The sheath is selected from among a plurality of sheaths each having a mesh member that is expandable to a different predetermined expanded diameter, the mesh region preventing the balloon member from developing bulges during inflation and constraining the edges of the balloon from perforating the vessel in the event of perforation. The sheath, which extends to a proximal end of the catheter, is also employed to reduce the diameter of the balloon member following the dilatation procedure, thereby preventing the balloon from bunching up in the vessel or organ.
235 Citations
20 Claims
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1. Apparatus for dilating a vessel or organ comprising:
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a catheter shaft having proximal and distal ends; a balloon disposed on the distal end of the catheter shaft; a sheath disposed surrounding the catheter shaft, the sheath having proximal and distal ends; and a mesh portion attached to the distal end of the sheath and disposed surrounding the balloon for sliding movement relative thereto, the mesh portion comprising a non-compliant material having a first state wherein the mesh portion has a first length and an insertion diameter and a second state wherein the mesh portion has second length, shorter than the first length, and a selected predetermined expanded diameter; and a retractor element disposed on the proximal end of the sheath for retracting the mesh portion to the first state, wherein, when the balloon is fully inflated, the mesh portion is in the second state and attains the selected predetermined expanded diameter, the mesh portion constraining the balloon from further expansion. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A kit for dilating a vessel or organ comprising:
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a catheter comprising a shaft having proximal and distal ends and a balloon disposed on the distal end of the shaft; and a sheath selected from among a plurality of sheaths, each one of the plurality of sheaths including a mesh portion having a predetermined expanded diameter, each one of the sheaths comprising; a tubular member having proximal and distal ends, the tubular member disposed surrounding the shaft; a mesh portion attached to the distal end of the tubular member and disposed surrounding the balloon for sliding movement relative thereto, the mesh portion comprising a non-compliant material having a first state wherein the mesh portion has a first length and an insertion diameter and a second state wherein the mesh portion has second length, shorter than the first length, and a predetermined expanded diameter; and a retractor element disposed on the proximal end of the tubular member for retracting the mesh portion to the first state, wherein, when the balloon is fully inflated, the mesh portion of the selected one of the plurality of sheaths is in the second state and attains the predetermined expanded diameter, the mesh portion constraining the balloon from further expansion. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method of dilating a constriction in a vessel or organ, the method comprising steps of:
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providing apparatus comprising a catheter a distal end and a balloon disposed on the distal end and a sheath disposed on the catheter, the sheath including a mesh portion aligned with and surrounding the balloon, the mesh portion arranged for sliding movement relative to the balloon, the mesh portion comprising a non-compliant material having a first state wherein the mesh portion has a first length and an insertion diameter and a second state wherein the mesh portion has second length, shorter than the first length, and a selected predetermined expanded diameter; pulling the sheath in a proximal direction so that the mesh portion assumes the first state; inserting a guidewire into the vessel or organ; advancing the apparatus along the guidewire to position the mesh portion and balloon within the constriction; and inflating the balloon so that the mesh portion expands to the second state and attains the selected predetermined diameter to disrupt the constriction, the mesh portion constraining the balloon from further expansion. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification