Implantable medical device assembly

• US 6,984,242 B2
• Filed: 12/20/2002
• Issued: 01/10/2006
• Est. Priority Date: 12/20/2002
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Campbell, Carey V., Wiley, William H.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Sweet, Thomas
• Application Number:
  US10/325,200
• Publication Number:
  US 20040122503A1
• Time in Patent Office: 1,117 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

The present invention is directed to implantable medical device assemblies. The assemblies are primarily used to introduce and deposit implantable medical devices in the vasculatures of implant recipients. The principle implantable medical device used in the assembly is an expandable element in the form of an endovascular device. The expandable element is maintained in a compacted configuration during introduction of the device into the vasculature with a confinement means. The expandable element is released from the confinement means at an implantation site with a control line. The control line has high tensile strength, high modulus, structural rigidity, and low compressibility. These features of the control line provide a practitioner with tactile feedback of the release of the expandable element from the confinement means. The tactile feedback is present during the entire deployment of the expandable element. The tactile feedback enables the practitioner to better track and control deployment of the expandable element at an implantation site.

Claims

1. An implantable medical device assembly comprising:

an expandable endovascular device;

confinement means containing said expandable endovascular device in a compacted configuration;

at least one control line comprising a monofilamentous non-fluoropolymer core and an expanded polytetrafluoroethylene cover surrounding the core, wherein the control line is removably attached to the confinement means by stitching; and

wherein the stitched control line has a stiffness sufficient to require essentially every stitch in the confinement means to be removed one stitch at a time;

whereby the stitched control line provides tactile feedback to a practitioner as essentially every stitch is removed from said confinement means, and wherein the tactile feedback is in the form of oscillating pulling forces that vary in magnitude as substantially every stitch is removed from the confinement means.

2. The implantable medical device assembly of claim 1 wherein said control line has a ratio of ultimate tensile strength divided by slip knot pull through force of greater than about 4.

3. The implantable medical device assembly of claim 1 wherein said control line has a ratio of ultimate tensile strength divided by slip knot pull through force of greater than about 5.

4. The implantable medical device assembly of claim 1 wherein said control line has a ratio of ultimate tensile strength divided by slip knot pull through force of greater than about 6.

5. The implantable medical device assembly of claim 1 wherein the endovascular device is a stent.

6. The implantable medical device assembly of claim 5 wherein the stent has a permanent covering placed on at least a portion of the stent.

7. The implantable medical device assembly of claim 1 wherein the endovascular device is a stent-graft.

8. The implantable medical device assembly of claim 1 wherein the endovascular device is an intra-cardiac device.

9. The implantable medical device assembly of claim 1 wherein the control line has a tensile strength of at least 14 pounds force.

10. The implantable medical device assembly of claim 1 wherein the core comprises an aramid polymer.

11. The implantable medical device assembly of claim 1 wherein the core comprises a liquid crystal polymer.

12. The implantable medical device assembly of claim 1 wherein the core comprises polyethyleneterephthalate.

13. The implantable medical device assembly of claim 1 wherein the core comprises polyamid.