Medical device delivery system

• US 20030144670A1
• Filed: 11/27/2002
• Published: 07/31/2003
• Est. Priority Date: 11/29/2001
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Pavcnik, Dusan, Case, Brian C., Flagle, Jacob A., Garrison, Mike, Dixon, Christopher G., Leonard, Ray II, Hoffa, Andrew K.
• Granted Patent: US 7,871,430 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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

A delivery system (10) for implanting a medical device (30) such as a venous valve into the vasculature of a patient. The delivery system includes a delivery catheter (11) having a device-containing portion (15) adjacent to the distal end (14) thereof, and an inner member (16) extending through the catheter and beyond the distal end thereof, to an atraumatic distal tip portion (17) forward of the catheter distal end. The inner member extends through the medical device in the device-containing region, includes a proximal portion (18) with a sufficiently large diameter to prevent longitudinal movement of the device as the catheter is retracted during deployment, and centers the device upon release from the distal catheter end during deployment. The inner member is preferably radiolucent underlying the device for contrast with radiopaque markers (43) of the device. The inner member preferably includes a flat portion (35) extending from the device-containing portion to the proximal end (22) to form a passageway or lumen (21) with the delivery catheter to transmit hydrating fluid to a device such as a valve containing lyophilized tissue requiring hydration immediately prior to patient implantation.

Claims

1. A medical device delivery system comprising:

a delivery catheter having an inner lumen extending from a proximal end to a distal end and having a device-containing region adjacent the distal end;

an inner member extendable through the delivery catheter from the proximal end to and through the device-containing region to and beyond the distal end of the delivery catheter, the inner member having a distal tip portion, a proximal portion, and an intermediate portion disposed between the distal tip portion and the proximal portion; and

wherein the proximal portion has a distal end that is sized approximating the inner lumen of the delivery catheter at least through the device-containing region and that engages a medical device when the medical device is positioned around the intermediate portion and in the device-containing region of the delivery catheter.

2. The delivery system of claim 1, wherein the intermediate portion is extendable through the device-containing region of the delivery catheter and wherein the proximal portion includes a proximal end region and an outer surface with a recessed portion communicating with the intermediate portion and extending to the proximal end region.

3. The delivery system of claim 1, wherein the intermediate portion is sized and shaped to engage the medical device when the medical device is positioned around the intermediate portion.

4. The delivery system of claim 1, wherein the inner member includes an inner lumen extending longitudinally therethrough.

5. The delivery system of claim 1, wherein the inner member includes an inner tube extending longitudinally in the proximal, intermediate, and distal tip portions.

6. The delivery system of claim 5, wherein the inner tube comprises a radiolucent material.

7. The delivery system of claim 5, wherein the inner member includes an outer tube disposed around the inner tube in the proximal portion.

8. The delivery system of claim 7, wherein the outer tube comprises a radiopaque material.

9. The delivery system of claim 7, wherein the outer tube includes a blunt distal end communicating with the intermediate portion.

10. The delivery system of claim 1, wherein the distal tip portion includes a tapered proximal end communicating with the intermediate portion.

11. The delivery system of claim 10, wherein the distal tip portion also includes a radiopaque marker.

12. The delivery system of claim 11, wherein the distal tip portion further includes an intermediate segment that is sized approximating the inner lumen of the delivery catheter about the distal end thereof.

13. The delivery system of claim 7, wherein the outer tube includes an outer surface that includes at least a recessed portion extending longitudinally therealong.

14. The delivery system of claim 13, wherein the delivery catheter includes a proximal portion having a lateral port that communicates with the recessed portion of the outer surface of the outer tube when the outer tube is positioned in the inner lumen of the delivery catheter.

15. The delivery system of claim 1, wherein the device-containing region of the delivery catheter includes a transparent material tube.

16. The delivery system of claim 1, further comprising an adapter connected to the proximal end of the delivery catheter and including a side arm communicating with a recessed portion of the inner member.

17. The delivery system of claim 1, further comprising an implantable medical device positionable around and engageable with the intermediate portion of the inner member and containable in the device-containing region of the delivery catheter, and wherein the medical device includes a lyophilized material that requires hydration prior to deployment.

25. The delivery system of claim 8, wherein the distal tip portion of the inner member includes a tapered proximal end extending to the intermediate portion.

18. A medical device delivery system comprising:

a delivery catheter having an inner lumen extending from a proximal end to a distal end and having a device-containing region adjacent the distal end;

an inner member extending through the delivery catheter from the proximal end to and through the device-containing region to and beyond the distal end of the delivery catheter, and having a distal tip portion; and

an implantable device contained in the device-containing region of the delivery catheter and around the inner member.

19. The delivery system of claim 18, wherein the inner member has an intermediate portion extending through the device-containing region and a proximal portion proximal of the intermediate portion and wherein the proximal portion includes an outer surface with a recessed portion extending from the intermediate portion to a proximal end region of the inner member adjacent to a fluid injection port of the delivery catheter, the recessed portion being in communication with the device-containing region of the delivery catheter.

20. The delivery system of claim 19, wherein the implantable device includes lyophilized material requiring hydration prior to deployment, whereby hydrating fluid is injectable into the fluid injection port and is transmitted along the recessed portion of the outer surface of the inner member within the delivery catheter to enter the device-containing region to hydrate the lyophilized material.

21. The delivery system of claim 19, wherein at least the intermediate portion of the inner member comprises a radiolucent material.

22. The delivery system of claim 18, wherein the inner member has an intermediate portion extending through the device-containing region and having a diameter less than a diameter of a proximal portion of the inner member and a diameter of the distal tip region of the inner member.

23. The delivery system of claim 22, wherein at least the intermediate portion of the inner member comprises a radiolucent material.

24. The delivery system of claim 23, wherein the implantable device includes at least one radiopaque marker that enables a clear contrast with the intermediate portion of the inner member.

26. The delivery system of claim 22, wherein the distal tip portion of the inner member includes an intermediate segment having a diameter about equal to a diameter of the inner lumen of the delivery catheter, and a tapered atraumatic distal end.

27. The delivery system of claim 22, wherein the proximal portion of the inner member adjacent to the intermediate portion and the device-containing region of the delivery catheter has a diameter approximating an inner diameter of the delivery catheter enabling the implantable device to abut the distal end of the proximal portion as the delivery catheter is being retracted during deployment of the implantable device at the deployment site, whereby no other member is needed to prevent proximal movement of the implantable device.

28. The delivery system of claim 18, wherein the inner member includes a guide wire lumen extending longitudinally therethrough, whereby enabling insertion of the delivery catheter containing the inner member over a guide wire in position in the patient.

29. The delivery system of claim 18, wherein the distal tip portion of the inner member includes a tapered distal end that is extendable beyond the distal end of the delivery catheter to engage a wall portion of the vessel spaced from the deployment site, thus tending to center the distal end of the delivery catheter within the vessel at the deployment site.

30. The delivery system of claim 29, wherein the implantable device includes at least one portion sufficiently engageable with the intermediate portion of the inner member, whereby the device tends to be initially centered within the vessel upon retraction of the distal end of the delivery catheter from therearound during deployment.