Apparatus and methods for delivery of intraluminal prosthesis

• US 6,344,044 B1
• Filed: 02/11/2000
• Issued: 02/05/2002
• Est. Priority Date: 02/11/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rizk, Isa, Pepa, Rogelio, Mouneimne, Karim, Fulkerson, John
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/503,618
• Time in Patent Office: 725 Days
• Field of Search: 606/108, 606/191, 606/192, 606/195, 606/198, 606/200, 128/898, 623/1.11, 623/1.12
• US Class Current: 606/108
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

An apparatus and method for intraluminal delivery and deployment of an expandable prosthesis at a site within a body canal is provided. The apparatus comprises an elongated sleeve and an outer shaft disposed within the elongated sleeve and movable relative to the sleeve. A securing member is disposed on a distal area of the outer shaft. The expandable prosthesis is housed within a distal area of the elongated sleeve, and a distal area of the prosthesis is secured to the outer shaft by the securing member. The stent is deployed by displacing the sleeve in a proximal direction relative to the outer shaft to expose the stent and by releasing the stent from the securing member. If necessary, the stent can be repositioned prior to releasing the stent from the securing member.

Claims

1. A method for deploying a prosthesis within a body canal, the method comprising:

providing an outer shaft having a distal area, the distal area having a securing member;

securing a distal area of the prosthesis onto the outer shaft with the securing member;

providing a sleeve having a distal area;

containing the prosthesis within the distal area of the sleeve and positioning the outer shaft within the sleeve;

the process further comprising the steps of;

positioning the prosthesis within the body canal at a desired location; and

deploying the prosthesis at the desired location by causing longitudinal motion between the sleeve and the outer shaft to expose the prosthesis, keeping the distal area of the prosthesis engaged with the securing member while permitting the exposed portion of the prosthesis to be free to partially expand;

wherein the step of providing a hand piece includes having a lever arm coupled to the sleeve;

actuating the lever arm to incrementally and precisely drive the sleeve in a longitudinal and proximal direction such that the sleeve moves in a proximal direction relative to the outer shaft;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

while re-positioning the prosthesis within the body canal at a desired location;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

the method likewise including the steps of;

providing an inner shaft having a distal area, the distal area having a tip;

positioning the inner shaft within the outer shaft in a slidable manner;

wherein the securing member is a fork-shaped element having at least one prong which engages with the distal area of the prosthesis;

lockingly securing the prosthesis onto the securing member by slidingly coupling the inner shaft with the outer shaft so that a distal end of the at least one prong abuts against a proximal end of the tip; and

releasing the prosthesis from the securing member by longitudinally and proximally sliding the inner shaft relative to the outer shaft so that the securing member is slidingly displaced away from the tip.

2. A method for deploying a prosthesis within a body canal, the method comprising:

providing an outer shaft having a distal area, the distal area having a securing member;

securing a distal area of the prosthesis onto the outer shaft with the securing member;

providing a sleeve having a distal area;

containing the prosthesis with the distal area of the sleeve and positioning the outer shaft within the sleeve;

the process further comprising the steps of;

positioning the prosthesis within the body canal at a desired location; and

deploying the prosthesis at the desired location by causing longitudinal motion between the sleeve and the outer shaft to expose the prosthesis, keeping the distal area of the prosthesis engaged with the securing member while permitting the exposed portion of the prosthesis to be free to partially expand;

wherein the step of providing a hand piece includes having a lever arm coupled to the sleeve;

actuating the lever arm to incrementally and precisely drive the sleeve in a longitudinal and proximal direction such that the sleeve moves in a proximal direction relative to the outer shaft;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

while re-positioning the prosthesis within the body canal at a desired location;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

the method likewise including the steps of;

providing an inner shaft having a distal area, the distal area having a tip;

positioning the inner shaft within the outer shaft in a slidable manner;

wherein the securing member is a fork-shaped element having at least one prong which engages with the distal area of the prosthesis;

lockingly securing the prosthesis onto the securing member by slidingly coupling the inner shaft with the outer shaft so that a distal end of the at least one prong abuts against a proximal end of the tip; and

releasing the prosthesis from the securing member by longitudinally and proximally sliding the inner shaft relative to the outer shaft so that the securing member is slidingly displaced away from the tip;

whereby, the process comprises the step of providing the tip with a side port for the release of a contrast medium into the body canal, whereby the contrast agent is released near the prosthesis, and whereby said tip is an atraumatic tip for reducing injury to the body canal.

3. A method for deploying a prosthesis within a body canal, the method comprising:

providing an outer shaft having a distal area, the distal area having a securing member;

securing a distal area of the prosthesis onto the outer shaft with the securing member;

providing a sleeve having a distal area;

containing the prosthesis within the distal area of the sleeve and positioning the outer shaft within the sleeve;

the process further comprising the steps of;

positioning the prosthesis within the body canal at a desired location; and

deploying the prosthesis at the desired location by causing longitudinal motion between the sleeve and the outer shaft to expose the prosthesis, keeping the distal area of the prosthesis engaged with the securing member while permitting the exposed portion of the prosthesis to be free to partially expand;

wherein the step of providing a hand piece includes having a lever arm coupled to the sleeve;

actuating the lever arm to incrementally and precisely drive the sleeve in a longitudinal and proximal direction such that the sleeve moves in a proximal direction relative to the outer shaft;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

while re-positioning the prosthesis within the body canal at a desired location;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

the method likewise including the steps of;

providing an inner shaft having a distal area, the distal area having a tip;

positioning the inner shaft within the outer shaft in a slidable manner;

wherein the securing member is a fork-shaped element having at least one prong which engages with the distal area of the prosthesis;

lockingly securing the prosthesis onto the securing member by slidingly coupling the inner shaft with the outer shaft so that a distal end of the at least one prong abuts against a proximal end of the tip; and

releasing the prosthesis from the securing member by longitudinally and proximally sliding the inner shaft relative to the outer shaft so that the securing member is slidingly displaced away from the tip;

wherein the hand piece further comprises a tube connecting the sleeve to the lever arm, so that actuating the lever drives the tube in a proximal direction and movement of the tube causes the sleeve to be driven in a proximal direction.

4. A method for deploying a prosthesis within a body canal, the method comprising:

providing an outer shaft having a distal area, the distal area having a securing member;

securing a distal area of the prosthesis onto the outer shaft with the securing member;

providing a sleeve having a distal area;

containing the prosthesis within the distal area of the sleeve and positioning the outer shaft within the sleeve;

the process further comprising the steps of;

positioning the prosthesis within the body canal at a desired location; and

deploying the prosthesis at the desired location by causing longitudinal motion between the sleeve and the outer shaft to expose the prosthesis, keeping the distal area of the prosthesis engaged with the securing member while permitting the exposed portion of the prosthesis to be free to partially expand;

wherein the step of providing a hand piece includes having a lever arm coupled to the sleeve;

actuating the lever arm to incrementally and precisely drive the sleeve in a longitudinal and proximal direction such that the sleeve moves in a proximal direction relative to the outer shaft;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

while re-positioning the prosthesis within the body canal at a desired location;

fully exposing the prosthesis while maintaining securement to the outer shaft by the securing member; and

releasing the prosthesis from the outer shaft by disengaging the securing member;

the method likewise including the steps of;

providing an inner shaft having a distal area, the distal area having a tip;

positioning the inner shaft within the outer shaft in a slidable manner;

wherein the securing member is a fork-shaped element having at least one prong which engages with the distal area of the prosthesis;

lockingly securing the prosthesis onto the securing member by slidingly coupling the inner shaft with the outer shaft so that a distal end of the at least one prong abuts against a proximal end of the tip; and

releasing the prosthesis from the securing member by longitudinally and proximally sliding the inner shaft relative to the outer shaft so that the securing member is slidingly displaced away from the tip;

biasing the tube in a distal direction with a spring, and,

additionally including the step of;

providing the hand piece with a release member to drive the outer shaft in a proximal direction relative to the inner shaft; and

actuating the release member to release the securing member from the prosthesis.