Apparatus and method for dilatation of a body lumen and delivery of a prothesis therein
First Claim
1. Apparatus for dilating a body lumen and retaining the body lumen patent, the apparatus comprising:
- a catheter having a proximal end region and a distal end region;
a balloon member disposed adjacent the distal end region for expanding an inner dimension of the body lumen, the balloon member comprising a biocompatible material;
a prosthesis at least partially disposed within the balloon member, the prosthesis having a first shape of reduced dimension and a second shape of expanded dimension; and
means for severing the balloon member from the distal end region of the catheter.
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Accused Products
Abstract
Apparatus and methods are provided for first expanding a body lumen of a body vessel or organ and then deploying a prosthesis to maintain the lumen patent. The apparatus includes a catheter having a balloon member formed of a biocompatible material, a balloon cutting element, and a thermally activated shape memory alloy prosthesis disposed within the balloon. The prosthesis is formed of nickel-titanium alloy having a reduced diameter in the martensite phase, and an expanded diameter in the austenite phase. The balloon member is inflated using a first fluid having a temperature below the martensite transition temperature to expand the body lumen and a second fluid having a temperature sufficient to cause the prosthesis to transition to the expanded diameter, trapping the material of the balloon member against the body wall. A cutting device disposed on the catheter then severs balloon member to release the prosthesis.
89 Citations
36 Claims
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1. Apparatus for dilating a body lumen and retaining the body lumen patent, the apparatus comprising:
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a catheter having a proximal end region and a distal end region; a balloon member disposed adjacent the distal end region for expanding an inner dimension of the body lumen, the balloon member comprising a biocompatible material; a prosthesis at least partially disposed within the balloon member, the prosthesis having a first shape of reduced dimension and a second shape of expanded dimension; and means for severing the balloon member from the distal end region of the catheter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. An apparatus for dilating a body lumen, the apparatus comprising;
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a catheter having a proximal end region and a distal end region; a balloon member comprising a biocompatible material disposed on the distal end region; a stent confined within the balloon member, the stent having a first shape of reduced dimension and a second shape of expanded dimension; and means for severing the balloon member from the distal end region of the catheter when the stent is in the second shape such that at least a portion of the balloon member is captured between the stent and an inner wall of the body lumen. - View Dependent Claims (13, 14, 15, 16)
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17. A method of dilating a body lumen and disposing a prosthesis within the body lumen, the method comprising steps of:
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providing an apparatus having a proximal end region and a distal end region, a balloon member formed of a biocompatible material disposed on the distal end region, a prosthesis at least partially disposed within the balloon member, the prosthesis having a first shape of reduced dimension and a second shape of expanded dimension; inserting the distal end region of the apparatus to a desired position within the body lumen; inflating the balloon member to expand the body lumen; expanding the prosthesis to the second shape within the balloon member; and severing the balloon member from the apparatus to deploy the prosthesis. - View Dependent Claims (18, 19, 20, 21)
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22. Apparatus for maintaining patency of a body vessel, which comprises:
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an elongated member defining a longitudinal axis and having proximal and distal ends, and being adapted to be positioned within a body vessel; an expandable member mounted to the elongated member and expandable to engage inner wall portions of the body vessel; and a prosthesis at least partially disposed within the expandable member, the prosthesis moveable to a deployed position to retain the expandable member against the inner wall portion of the body vessel and maintain an inner dimension of a lumen of the body vessel. - View Dependent Claims (23, 24, 25, 26, 27, 28)
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29. An apparatus for maintaining the patency of a body vessel, which comprises:
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a catheter defining a longitudinal axis and having proximal and distal end portions, and having an inflation channel associated therewith for passage of inflation media; a balloon member mounted adjacent the distal end portion of the catheter and in communication with the inflation channel, the balloon member inflatable to engage an inner wall of the body vessel; a stent disposed within the balloon member, the stent comprising a shape memory material and being capable of moving from an initial condition to an expanded condition in response to a predetermined temperature level of inflation media introduced within the balloon member, to retain the balloon member against the inner wall of the body vessel and maintain the patency of the body vessel; and a cutting member mounted with respect to the catheter and longitudinally movable to sever the balloon member from the catheter, to thereby release the balloon member and the stent within the body vessel.
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30. A method for maintaining the patency of a body organ, comprising the steps of:
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positioning an elongated member into a body passage, the elongated member including an inflatable membrane and a prosthesis at least partially disposed within the inflatable membrane; inflating the inflatable membrane to cause engagement thereof with the inner wall portion of the body organ; and expanding the prosthesis to cause engagement thereof with the inflatable membrane to maintain the inflatable membrane against the inner wall portion to thereby maintain the patency of the body organ. - View Dependent Claims (31, 32, 33, 34, 35, 36)
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Specification