Introducer for self-expandable medical device

• US 20070016281A1
• Filed: 07/11/2006
• Published: 01/18/2007
• Est. Priority Date: 07/13/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry
• Granted Patent: US 8,118,852 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

An introducer apparatus for deploying a self-expandable medical device, such as a stent, to a target area of a body vessel of a patient comprises a shaft having a proximal end and a distal end, and a distal end portion disposed at the shaft distal end. The distal end portion comprises an introducer body and at least one deployment member. The introducer body is sized and shaped relative to the self-expandable medical device such that the medical device is receivable on a surface of the introducer body when the medical device is in a compressed condition. The deployment member is configured and arranged relative to the introducer body for selectively restraining the self-expandable medical device in the compressed condition on the introducer apparatus surface.

Claims

1. An introducer apparatus for deploying a self-expandable medical device, comprising:

a shaft having a proximal end and a distal end; and

a distal end portion disposed at said shaft distal end, said distal end portion comprising an introducer body and at least one deployment member, said introducer body sized and shaped relative to a size and shape of said self-expandable medical device such that said medical device is receivable on a surface of said introducer body when said medical device is in a compressed condition, said at least one deployment member configured and arranged relative to said introducer body for selectively restraining said self-expandable medical device in said compressed condition on said surface.

2. The introducer apparatus of claim 1, wherein said introducer body comprises a plurality of spaced support rings joined by at least one elongated strut.

3. The introducer apparatus of claim 2, wherein said support rings comprise alternating lobe portions and depressed portions.

4. The introducer apparatus of claim 3, wherein each said support ring is rotationally oriented in an offset manner relative to an adjacent support ring, and said struts join said support rings by attachment to respective depressed portions of said rings.

5. The introducer apparatus of claim 2, wherein said introducer body and said at least one deployment member are engaged such that said introducer body, deployment member and compressed medical device comprise a generally smooth longitudinal profile.

6. The introducer apparatus of claim 2, wherein said at least one deployment member comprises a plurality of deployment members, each of said deployment members being longitudinally disposed substantially intermediate said introducer body and said compressed medical device.

7. The introducer apparatus of claim 1, wherein said introducer body comprises a generally cylindrical body member, said generally cylindrical body member having one or more projections radially extending therefrom, said projections configured for receiving said at least one deployment member for effecting said restraint of said medical device.

8. The introducer apparatus of claim 7, wherein said projections comprise respective tab members extending in a radially outward direction from said generally cylindrical body member, at least some of said tab members including an aperture for receiving said at least one deployment member.

9. The introducer apparatus of claim 7, wherein said projections comprise respective tab members extending in a radially inward direction from said generally cylindrical body member, at least some of said tab members including an aperture for receiving said at least one deployment member.

10. The introducer apparatus of claim 1, comprising a control mechanism for selectively retracting said at least one deployment member relative to said introducer body to cause expansion of said medical device.

11. The introducer apparatus of claim 10, further comprising a control wire disposed between said control mechanism and said one or more deployment members.

12. The introducer apparatus of claim 2, wherein said support rings are joined by at least two struts, said introducer apparatus further comprising a distal tip member, said distal tip member configured for fixedly receiving a distal end of said struts.

13. The introducer apparatus of claim 12, wherein said distal tip portion comprises at least two deployment members, and wherein said distal tip member is configured for releasably receiving a distal end of said deployment members.

14. A method for deploying a self-expandable medical device in a target area of a body vessel of a patient, comprising:

providing an introducer apparatus for insertion into said body vessel, said introducer apparatus comprising a shaft and a distal end portion disposed at a distal end of said shaft, said distal end portion comprising an introducer body and at least one deployment member removably engageable with said introducer body, said introducer body sized and shaped relative to a size and shape of said self-expandable medical device such that said medical device is receivable on a surface of said introducer body when said medical device is in a compressed condition, said at least one deployment member configured and arranged for selectively restraining said compressed self-expandable medical device during engagement with said introducer body;

loading said self-expandable medical device in a compressed condition onto said surface of said introducer body such that said medical device is restrained in said compressed condition by said at least one deployment member;

inserting said distal end portion of said introducer apparatus having said medical device loaded thereon into said vessel, and directing said introducer apparatus through said vessel such that said distal end portion is positioned at said target area;

withdrawing said at least one deployment member such that said medical device is released from said compressed condition and self-expands to an expanded condition at said target area; and

withdrawing said introducer apparatus from said vessel.

15. The method of claim 14, further comprising:

inserting a wire guide into said vessel target area;

inserting said distal end portion of said introducer apparatus to said target area over said wire guide.

16. The method of claim 15, wherein said introducer apparatus further comprises a control mechanism, and wherein said control mechanism is operable for controlling said withdrawal of said at least one deployment member.

17. The method of claim 15, wherein said at least one deployment member is withdrawn in a proximal direction.

18. The method of claim 15, wherein said medical device is loaded onto an outer surface of said introducer body.

19. The method of claim 15, wherein said introducer body comprises a plurality of spaced support rings, said spaced support rings being joined by at least one elongated strut.

20. The method of claim 19, wherein said support rings are joined by at least two struts, said introducer apparatus further comprising a distal tip member configured for fixedly receiving a distal end of said struts, said distal tip member further comprising at least one channel for removably receiving a distal end of said at least one deployment member.