Infundibular Reducer Device Delivery System and Related Methods

• US 20090192601A1
• Filed: 01/23/2009
• Published: 07/30/2009
• Est. Priority Date: 01/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Douk, Nareak, Rafiee, Nasser, House, Morgan, Bonhoeffer, Philipp
• Granted Patent: US 9,364,324 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

Described is a delivery system for minimally invasive delivery of a self-expandable stent to a body lumen, and particularly delivery of a prosthetic valve to the right ventricular outflow tract. Also described is a method of loading a stent onto such a delivery system, and a method of delivering a self-expandable stent to a desired anatomic site.

Claims

1. A delivery system for delivery of a device to a body lumen, the device comprising a proximal end and a distal end, a central lumen there through, and a plurality of attachment members located at or near the proximal end, the system comprising:

an elongated inner catheter having a proximal end and a tapered, distal end for insertion into a body lumen;

an elongated holding catheter having a proximal end, a distal end, a center lumen passing there through to slidably maintain the inner catheter and a coil on the distal end for attachment to the plurality of attachment members on the device; and

an elongated outer sheath having a proximal and a distal end and a center lumen passing there through to slidably and rotatably maintain the holding catheter, to collapse the device as the holding catheter is slid proximally there through, and to hold the device in a collapsed configuration for delivery to a body lumen.

2. The delivery system of claim 1, wherein the outer sheath further comprises a funnel removably connected to the distal end for collapsing the device as the holding catheter is slid proximally there through.

3. The delivery system of claim 1, further comprising a loading rail that comprises a substantially circular shaped flexible tube with two free ends, wherein the loading rail is attachable to the plurality of attachment members on the device and comprises a first end that is removably attachable to the coil to provide a continuous path for the attachment members of the device to be transferred from the loading rail to the coil.

4. The delivery system of claim 1, further comprising the device.

5. The delivery system of claim 1, wherein the device further comprises a replacement valve that is attached within the central lumen of the device.

6. The delivery system of claim 1, wherein the plurality of attachment members comprise loops.

7. The delivery system of claim 1, further comprising dye injection ports in the outer sheath through which dye may flow from the system to a body lumen.

8. The delivery system of claim 1, wherein the device is self-expandable.

9. The delivery system of claim 1, further comprising at least one purging vent at or near the distal end of the inner catheter through which fluid injected into the inner catheter is able to escape the system.

10. A method of loading a device onto a delivery system, the method comprising the steps of:

receiving a self-expanding device having a proximal end and a distal end, a central lumen there through, and a plurality of attachment members located at or near the proximal end;

receiving a delivery system comprising a loading rail having two free ends, an elongated inner catheter having a proximal end and a tapered distal end, an elongated holding catheter having a proximal end and a distal end comprising a coil for attachment to the device and a center lumen passing there through to slidably maintain the inner catheter and the coil, and an elongated outer sheath having a proximal and a distal end and a center lumen passing there through;

extending the inner catheter through the lumen of the holding catheter and extending both the inner catheter and holding catheter through the lumen of the outer sheath;

threading the plurality of attachment members onto the loading rail;

connecting one free end of the loading rail to the coil on the holding catheter;

advancing the plurality of attachment members along the loading rail and onto the coil, wherein the advancing procedure partially collapses the device;

removing the loading rail from the coil after all of the attachment members are transferred to the coil;

collapsing the device in the outer sheath by sliding outer sheath over the stent; and

enclosing the collapsed device by retracting the inner catheter proximally and pulling the distal tapered end into the distal end of the outer sheath.

11. The method of claim 10, wherein the plurality of attachment members comprise loops.

12. The method of claim 10, wherein the device is a prosthetic valve further comprising a replacement valve that is attached to the device within the central lumen.

13. A method of delivering a self-expandable device to a desired anatomic site, the method comprising the steps of:

receiving a delivery system comprising;

a device having a proximal end and a distal end and a central lumen there through, and a plurality of attachment members at the proximal end;

an elongated inner catheter having a proximal end and a tapered, distal end for insertion into a body lumen;

an elongated holding catheter having a proximal end and a distal end and a center lumen that slidably maintains the inner catheter passing there through, and a coil on the distal end attached to the plurality of attachment members on the device; and

an elongated outer sheath having a proximal and a distal end and a center lumen passing there through slidably and rotatably maintaining the holding catheter and inner catheter, the distal, tapered end of the inner catheter maintained in the distal end of the outer sheath, and holding and enclosing the device in a collapsed configuration for delivery to a desired anatomic site;

advancing the delivery system intraluminally toward the anatomic site;

upon reaching the anatomic site, retracting the outer sheath to allow the stent to partially expand;

rotating the holding catheter in order to release the attachment members of the device from the coil and allowing the device to expand, thereby releasing the device from the delivery system; and

removing the delivery system from the anatomic site.

14. The method of claim 13, wherein the device further comprises a replacement valve connected to the device in the central lumen of the device.

15. The method of claim 14, wherein the plurality of attachment members comprise loops.

16. The method of claim 13, wherein the delivery system further comprises dye injection ports through which dye may flow from the system to the anatomic site, and further comprising the step of delivering dye through the dye injection ports.

17. The method of claim 16, wherein the dye is delivered under visualization.

18. The method of claim 17, wherein visualization is achieved by using a procedure chosen from the group consisting of fluoroscopy, echocardiography, intravascular ultrasound, angioscopy and real-time magnetic resonance imaging.