Delivery system for percutaneous placement of a medical device and method of use thereof

• US 8,814,847 B2
• Filed: 07/13/2007
• Issued: 08/26/2014
• Est. Priority Date: 07/13/2007
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Hoffman, Grant T., Bailey, F. Kristen
• Primary Examiner(s): Vu, Quynh-Nhu H
• Assistant Examiner(s): WILSON, LARRY ROSS
• Application Number:
  US11/827,848
• Publication Number:
  US 20090018529A1
• Time in Patent Office: 2,601 Days
• Field of Search: 606/108, 606/109, 606/194, 623/1.11, 623/1.12, 604/264, 604/272, 604/523, 604/533
• US Class Current: 604/523
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

A delivery system for implanting a medical device into the body of a patient or subject and a method of use thereof. The delivery system includes a delivery catheter having a catheter lumen and an inner member extending therethrough. The inner member includes a distal tip portion, a proximal portion, and an intermediate portion, the intermediate portion being disposed adjacent to the distal end of the delivery catheter. A first sealing member, positioned near a distal end of the proximal portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. A second sealing member, positioned near a proximal end of the distal tip portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. The intermediate portion extends between the first seal and the second seal. In one embodiment, a medical device and a hydrating fluid are present in a device-containing region between the intermediate portion and the delivery catheter.

Claims

1. A delivery system comprising:

a delivery catheter having an catheter lumen extending from a proximal end of the delivery catheter to a distal end of the delivery catheter;

an inner member extending through the catheter lumen, the inner member comprising a distal tip portion, a proximal portion, an intermediate portion and an inner lumen extending longitudinally therethrough from a proximal end of the inner member to a distal end of the inner member, wherein the intermediate portion is disposed adjacent to the distal end of the delivery catheter;

a first sealing member positioned between the inner member and the delivery catheter, wherein the first sealing member forms a fluid seal between the inner member and an inside surface of the delivery catheter;

a second sealing member positioned distally from the first sealing member between the inner member and the delivery catheter, wherein the second sealing member forms a fluid seal between the inner member and an inside surface of the delivery catheter;

wherein the intermediate portion is at least that portion extending between the first sealing member and the second sealing member;

a device-containing region between the intermediate portion and the delivery catheter, wherein the device-containing region is defined by the first sealing member and the second sealing member

a delivery lumen extending longitudinally through the inner member from near a proximal end of the inner member and being in fluid communication with the device-containing region;

a side port in the delivery catheter providing fluid communication between the device-containing region and an outside of the delivery catheter when the side port is positioned proximally of the second sealing member and distally of the first sealing member; and

wherein the delivery catheter is movable relative to the inner member to position the side port distally of the second sealing member thereby the side port does not provide fluid communication between the device-containing region and the outside of the delivery catheter, the device-containing region thereby being entirely sealed from the outside of the delivery catheter.

2. The delivery system of claim 1, wherein the intermediate portion is sized and shaped to engage a medical device between the inner member and the delivery catheter.

3. The delivery system of claim 2, wherein the implantable medical device is an expandable medical device requiring or benefiting from maintenance of hydration of at least part of the implantable medical device.

4. The delivery system of claim 1, further comprising an implantable medical device positioned within the device-containing region.

5. The delivery system of claim 1, further comprising a hydrating fluid contained within the device-containing region.

6. The delivery system of claim 1, wherein at least one of the first sealing member and the second sealing member is a ring seal.

7. The delivery system of claim 6, wherein at least one of the first sealing member and the second sealing member is an O ring seal.

8. The delivery system of claim 1, wherein the inner member comprises a radiolucent material.

9. The delivery system of claim 1, wherein the delivery catheter comprises a radiopaque material.

10. A kit comprising the delivery system of the claim 1, further comprising an implantable medical device positioned in the device-containing region of the delivery system and a hydration fluid contained in the device-containing region and in contact with at least a portion of the medical device.

11. The kit of claim 10, wherein the first sealing member and the second sealing member attach to the inner member.

12. The delivery system of claim 1, where the fluid seal formed by the first sealing member and by the second sealing member is sufficient to maintain a hydrating environment within the device-containing region.

13. The delivery system of claim 1, wherein the first sealing member and the second sealing member attach to the inner member.

14. A delivery system comprising:

a delivery catheter having a catheter lumen extending from a proximal end of the delivery catheter to a distal end of the delivery catheter;

an inner member extending through the catheter lumen, the inner member comprising a distal tip portion, a proximal portion, an intermediate portion and a delivery lumen extending longitudinally therethrough from near a proximal end of the inner member to a device-containing region positioned between the intermediate portion and the delivery catheter, wherein the intermediate portion is disposed adjacent to the distal end of the delivery catheter;

a first sealing member positioned between the inner member and the delivery catheter, wherein the first sealing member forms a fluid seal between the inner member and an inside surface of the delivery catheter;

a second sealing member positioned distally from the first sealing member between the inner member and the delivery catheter, wherein the second sealing member forms a fluid seal between the inner member and an inside surface of the delivery catheter, wherein the intermediate portion is that portion extending between the first seal and the second seal;

a lateral port in fluid communication with a proximal end of the delivery lumen;

a side port in the delivery catheter providing fluid communication between the device-containing region and an outside of the delivery catheter when the side port is positioned proximally of the second sealing member and distally of the first sealing member;

a hydrating fluid contained within the device-containing region;

an implantable medical device positioned within the device-containing region, wherein at least a portion of the implantable medical device contacts the hydrating fluid; and

wherein the delivery catheter is movable relative to the inner member to position the side port distally of the second sealing member thereby the side port does not provide fluid communication between the device-containing region and the outside of the delivery catheter, the device-containing region thereby being entirely sealed from the outside of the delivery catheter.

15. The delivery system of claim 14, wherein the first sealing member and the second sealing member attach to the inner member.