STABILITY DEVICE FOR USE WITH PERCUTANEOUS DELIVERY SYSTEMS

• US 20120209375A1
• Filed: 02/09/2012
• Published: 08/16/2012
• Est. Priority Date: 02/11/2011
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Madrid, Gilbert, Sok, Sam, Le, Thanh Huy, Winston, Matthew T., Tran, Tri D., Le, Kim
• Application Number:
  US13/370,215
• Publication Number:
  US 20120209375A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Claims

1. A delivery system for stabilizing a catheter shaft near a treatment location within a patient'"'"'s body, the system comprising:

a catheter shaft having a distal end portion, the distal end portion having increased stiffness relative to rest of the catheter shaft; and

at least one pull wire extending from the distal end portion of the catheter shaft to a proximal portion, the pull wire being configured to cause the distal end portion to flex to wedge the distal end portion of the catheter shaft within the aortic arch.

2. The delivery system of claim 1, wherein the pull wire is configured to flex the distal end portion so that a first portion of the distal end portion contacts the inner wall of the aortic arch and a second portion of the distal end portion contacts the outer wall of the aortic arch.

3. The delivery system of claim 1, wherein the distal end portion comprises a plurality of locking sections, the locking sections being moveable between an unlocked state in which the locking sections are moveable relative to one another and a locked state in which the locking sections are fixed relative to one another, the locked state being achieved by pulling on the pull wire.

4. The delivery system of claim 3, wherein the locking sections comprise interlocking tubes that have respective chamfered proximal portions that are sized to be received into a distal opening of an adjacent interlocking tube.

5. The delivery system of claim 1, wherein the distal end portion having increased stiffness relative to rest of the catheter shaft comprises a slotted tube embedded in the catheter shaft.

6. The delivery system of claim 1, wherein the distal end portion having increased stiffness relative to rest of the catheter shaft comprises a coiled member embedded in the catheter shaft.

7. The delivery system of claim 1, wherein the catheter shaft is a balloon catheter.

8. The delivery system of claim 1, wherein the distal end portion of the catheter shaft comprise at least a first articulating area and a second articulating area so that when a force is applied to the at least one pull wire, the first articulating portion bends toward an outer wall of the aortic arch and the second articulating portion to bends toward an inner wall of the aortic arch to wedge the catheter shaft within the aortic arch.

9. The delivery system of claim 1, further comprising:

an expansion device configured to extend from the distal end portion of the catheter shaft to expand a prosthetic device, the expansion device comprising an inner expandable member and a plurality of outer expandable members,

wherein the plurality of outer expandable members at least partially surround the inner expandable member and when the expandable member is in the expanded configuration, gaps between adjacent outer expandable members provide perfusion passageways across the expansion device.

11. The delivery system of claim 8, wherein the one or more stability members comprises a plurality of wires.

12. The delivery system of claim 8, wherein the one or more stability members comprise a generally flat strip.

10. A delivery system for stabilizing a catheter shaft near a treatment location within a patient'"'"'s body, the system comprising:

a catheter shaft having one or more lumens that extend along the length the catheter shaft, the one or more lumens;

one or more stability members sized to be received within respective ones of the one or more lumens of the catheter shaft to increase the stiffness of the catheter shaft at a distal end portion of the catheter shaft; and

at least one pull wire extending from the distal end portion of the catheter shaft to a proximal portion, the pull wire being configured to cause the distal end portion to flex to wedge the catheter shaft within the aortic arch.

13. A method of stabilizing a catheter shaft near a treatment location within a patient'"'"'s body, the method comprising:

delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, the distal end portion having increased stiffness relative to rest of the elongate shaft; and

pulling at least one pull wire that extends from the distal end portion of the elongate shaft to a proximal portion to flex the distal end portion so that a first portion of the catheter shaft contacts the inner wall of the aortic arch and a second portion of the catheter shaft contacts the outer wall of the aortic arch to wedge the catheter shaft within the aortic arch.

14. The method of claim 13, wherein the distal end portion comprises a plurality of locking sections and the act of pulling on the at least one pull wire causes the locking sections to transition from an unlocked state in which the locking sections are moveable relative to one another and a locked state in which the locking sections are fixed relative to one another.

15. The method of claim 14, wherein the locking sections comprise interlocking tubes that have respective chamfered proximal portions that are sized to be received into a distal opening of an adjacent interlocking tube.

16. The method of claim 13, wherein the distal end portion of the catheter shaft comprises at least a first articulating area and a second articulating area, the first articulating area being proximal to the second articulating area, and pulling the at least one pull wire causes the first articulating portion to bend toward an outer wall of the aortic arch and the second articulating portion to bend toward an inner wall of the aortic arch, the opposing bending directions of the first and second articulating portions causing a first proximal portion of the catheter shaft to contact the inner wall of the aortic arch and a second distal portion of the catheter shaft to contact the outer wall of the aortic arch to wedge the catheter shaft within the aortic arch.

17. The method of claim 13, wherein the distal end portion of the catheter shaft has at least a first bend area and a second bend area that allow for a higher amount of bending than at other areas of the catheter shaft, the first and second bend areas being spaced apart from one another, wherein pulling the at least one pull wire causes the elongate shaft to bend at the first and second bend points to cause the elongate shaft to wedge within the aortic arch,

18. The method of any of claim 13, further comprising:

expanding an expansion device that extends from the distal end portion of the catheter shaft, the expansion device comprising a balloon member for expanding a prosthetic device or performing a valvuloplasty procedure,

wherein the expansion device comprises an inner expandable member and a plurality of outer expandable members, and the plurality of outer expandable members at least partially surround the inner expandable member and the expanding of the expansion device provides gaps between adjacent outer expandable members to provide perfusion passageways across the expansion device.

19. A method of stabilizing a catheter shaft near a treatment location within a patient'"'"'s body, the method comprising:

delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, the catheter shaft having at least one lumen extending from the distal end portion to a portion of the catheter shaft external to the patient'"'"'s body;

inserting at least one stability member through the at least one lumen to cause the distal end portion of the catheter shaft to stiffen and move into contact with a portion of an outer wall of the aortic arch to stabilize the catheter shaft within the aortic arch.

20. The method of claim 19, wherein the at least one lumen includes a plurality of lumens and the at least one stability member includes a plurality of stability members, and the plurality of stability members are inserted into respective ones of the plurality of lumens.

21. The method of claim 19, further comprising:

expanding an expansion device that extends from the distal end portion of the catheter shaft, the expansion device comprising a balloon member for expanding a prosthetic device or performing a valvuloplasty procedure,

wherein the expansion device comprises an inner expandable member and a plurality of outer expandable members, and the plurality of outer expandable members at least partially surround the inner expandable member and the expanding of the expansion device provides gaps between adjacent outer expandable members to provide perfusion passageways across the expansion device.