Deployable and retrievable shape memory stent/tube and method

• US 5,800,516 A
• Filed: 08/08/1996
• Issued: 09/01/1998
• Est. Priority Date: 08/08/1996
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Solovay, Kenneth S., Fine, Michael J.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): NGUYEN, TRAM A
• Application Number:
  US08/693,708
• Time in Patent Office: 754 Days
• Field of Search: 623/1, 623/11, 623/12, 606/78, 606/191, 606/192, 606/194, 606/195, 606/198
• US Class Current: 128/898
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply

Abstract

A method for the deployment and retrieval of a tubular member. The method is achieved by first introducing a tubular member having a first diameter to a preselected treatment site, wherein said tubular member exhibits shape memory characteristics. The tubular member is then expanded to a second diameter at the treatment site and deployed at the treatment site. After a predetermined time, the tubular member is retrieved from the treatment site by causing the tubular member to return to its first diameter and withdrawing the tubular member from the treatment site. A tubular member with shape memory characteristics for use in accordance with the method is also provided.

Claims

1. A method for the deployment and retrieval of a shape memory plastic tubular member at a preselected treatment site within a patient, comprising the following steps:

introducing a shape memory plastic tubular member, having a first diameter, to a preselected treatment site with a dilatation balloon catheter;

heating the shape memory plastic tubular member with the dilatation balloon catheter to a temperature where the shape memory plastic tubular member is malleable and expanding the dilatation balloon catheter until the share memory plastic tubular member reaches a desired second diameter at the treatment site;

deploying the shape memory plastic tubular member at the treatment site;

retrieving the shape memory plastic tubular member from the treatment site by heating the tubular member to, or above, a transition temperature of the shape memory plastic tubular member to cause the shape memory plastic tubular member to begin to return to its first diameter, continuously heating the shape memory plastic tubular member at, or above, the transition temperature until the shape memory plastic tubular member returns to its first diameter, and withdrawing the shape memory plastic tubular member from the treatment site.

2. The method according to claim 1, wherein the step of introducing includes positioning the shape memory plastic tubular member about the dilatation balloon catheter and inserting the dilatation balloon catheter to the treatment site.

3. The method according to claim 2, wherein the dilatation balloon catheter is a thermodynamic dilatation balloon catheter.

4. The method according to claim 2, wherein the shape memory plastic tubular member is a stent.

5. The method according to claim 4, wherein the dilatation balloon catheter is a thermodynamic dilatation balloon catheter.

6. The method according to claim 2, wherein the step of retrieving includes positioning the dilatation balloon catheter at the treatment site, expanding the dilatation balloon catheter, heating the dilatation balloon catheter to heat the shape memory plastic tubular member to, or above, the transition temperature of the shape memory plastic tubular member, deflating the balloon dilatation catheter while the dilatation balloon catheter continuously applies heat to maintain the shape memory tubular member at, or above, its transition temperature and the shape memory plastic tubular member returns to its first diameter, and withdrawing the dilatation balloon catheter and the shape memory plastic tubular member.

7. The method according to claim 1, wherein the step of retrieving includes positioning the dilatation balloon catheter at the treatment site, expanding the dilatation balloon catheter, heating the dilatation balloon catheter to heat the shape memory plastic tubular member to, or above, the transition temperature of the shape memory plastic tubular member, deflating the balloon dilatation catheter while the dilatation balloon catheter continuously applies heat to maintain the shape memory tubular member at, or above, its transition temperature and the shape memory plastic tubular member returns to its first diameter, and withdrawing the dilatation balloon catheter and the shape memory plastic tubular member.

8. The method according to claim 7, wherein the dilatation balloon catheter is a thermodynamic dilatation balloon catheter.

9. The method according to claim 1, wherein the tubular member is a stent.

10. A method for the deployment and retrieval of a shape memory plastic stent, comprising the following steps:

positioning a shape memory plastic stent having a first diameter on a dilatation balloon catheter, wherein the dilatation balloon catheter is capable of applying heat to the stent;

introducing the dilatation balloon catheter and the stent to a predetermined treatment site;

heating the dilatation balloon catheter to heat the shape memory plastic stent to a temperature where the shape memory plastic stent becomes malleable;

expanding the shape memory plastic stent to a second diameter at the treatment site;

deflating and withdrawing the dilatation balloon catheter to thereby deploy the shape memory plastic stent at the treatment site;

positioning the dilatation balloon catheter at the treatment site;

expanding the dilatation balloon catheter;

heating the dilatation balloon catheter to heat the shape memory plastic stent until the shape memory plastic stent reaches its transition temperature at which the shape memory plastic stent will begin to return to its first diameter;

continuously heating the shape memory plastic stent to, or above, its transition temperature while deflating the balloon dilatation catheter until the shape memory plastic stent returns to its first diameter; and

withdrawing the dilatation balloon catheter and the shape memory plastic stent.

11. The method according to claim 10, wherein the dilatation balloon catheter is a thermodynamic dilatation balloon catheter.