Device and methods for self-centering a guide catheter

• US 9,889,006 B2
• Filed: 07/22/2014
• Issued: 02/13/2018
• Est. Priority Date: 07/22/2013
• Status: Active Grant

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Inventors: Sandhu, Gurpreet S., Spoon, Daniel B., Tefft, Brandon J.
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US14/906,393
• Publication Number:
  US 20160158006A1
• Time in Patent Office: 1,302 Days
• Field of Search: 604528, 606200, 623 124, 623 218
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

This document provides devices and methods for the treatment of heart conditions such as valvular stenosis. For example, this document provides devices and methods by which a guide catheter can align itself with a blood flow stream to thereby help direct a guidewire or other elongate device transmitted from the guide catheter through an orifice of a heart valve.

Claims

1. A device for centering a medical instrument in a conduit within a patient, the device comprising:

a framework comprised of a plurality of elongate metal frame members, wherein the frame members are attached to each other to define a central lumen having an open proximal end and an open distal end, wherein the distal end has a diameter that is larger than a diameter of the proximal end, and wherein the frame members are attached to each other to further define two or more side apertures that are nearer to the proximal end than to the distal end; and

a covering, wherein the covering is attached to the framework and the covering is a biocompatible membrane or film, wherein the side apertures define open fluid flow paths that are not occluded by the covering.

2. The device of claim 1, wherein the plurality of elongate metal frame members are comprised of nitinol, wherein the device is collapsible to a low-profile configuration adapted for confinement within a delivery sheath, and wherein the device can self-expand to an expanded configuration when the device is not contained within the delivery sheath.

3. The device of claim 1, wherein the frame members are attached to each other to further define four or more side apertures that are nearer to the proximal end than to the distal end.

4. The device of claim 1, wherein the side apertures are symmetrically positioned about a longitudinal axis of the device.

5. The device of claim 1, wherein the plurality of elongate metal frame members form a plurality of petals.

6. The device of claim 5, wherein adjacent petals of the plurality of petals overlap each other.

7. The device of claim 6, wherein the plurality of petals are hinged to a proximal end collar of the device.

8. The device of claim 1, wherein the framework is bell-shaped.

9. The device of claim 8, wherein the framework is shape-set into the bell-shape.

10. The device of claim 9, wherein the plurality of elongate metal frame members comprise nitinol.

11. The device of claim 10, wherein the plurality of elongate metal frame members are made from a tube of nitinol that is cut and expanded into the bell-shape.

12. The device of claim 8, wherein a diameter of the central lumen gradually decreases in a direction from the distal end to the proximal end.

13. The device of claim 1, further comprising one or more radiopaque markers.

14. The device of claim 1, wherein the framework is funnel-shaped.

15. A system for treating a human patient, the system comprising:

a self-centering device comprising;

a framework comprised of a plurality of elongate metal frame members, wherein the frame members are attached to each other to define a central lumen having an open proximal end and an open distal end, wherein the distal end has a diameter that is larger than a diameter of the proximal end, and wherein the frame members are attached to each other to further define two or more side apertures that are nearer to the proximal end than to the distal end; and

a covering, wherein the covering is attached to the framework and the covering is a biocompatible membrane or film, wherein the side apertures define open fluid flow paths that are not occluded by the covering;

a guidewire comprising an elongate metal wire; and

a guide catheter with a lumen, wherein the self-centering device and the guidewire are arranged to be contained within the lumen, wherein the self-centering device is in a low-profile configuration when the self-centering device is contained within the lumen, and wherein the self-centering device can self-expand to an expanded configuration when the self-centering device is not contained within the lumen.

16. A method for treating a human patient, the method comprising:

providing a medical device system comprising;

a self-centering device comprising;

a framework comprised of a plurality of elongate metal frame members, wherein the frame members are attached to each other to define a central lumen having an open proximal end and an open distal end, wherein the distal end has a diameter that is larger than a diameter of the proximal end, and wherein the frame members are attached to each other to further define two or more side apertures that are nearer to the proximal end than to the distal end; and

a covering, wherein the covering is attached to the framework and the covering is a biocompatible membrane or film, wherein the side apertures define open fluid flow paths that are not occluded by the covering;

a guidewire comprising an elongate metal wire; and

a guide catheter with a lumen, wherein the self-centering device and the guidewire are arranged to be contained within the lumen, wherein the self-centering device is in a low-profile configuration when the self-centering device is contained within the lumen, and wherein the self-centering device can self-expand to an expanded configuration when the self-centering device is not contained within the lumen;

inserting the guide catheter containing the self-centering device and the guidewire into the patient;

directing the guide catheter to a target site within the patient;

causing the self-centering device to emerge from a distal end of the guide catheter, wherein the self-centering device reconfigures from the low-profile configuration to the expanded configuration when the self-centering device emerges from the guide catheter; and

causing the guidewire to emerge from a distal end of the guide catheter.

17. The method of claim 16, wherein the method is used to treat a stenotic aortic valve of the patient.

18. The method of claim 16, wherein the method is used to treat perivalvular aortic or mitral valve leaks, or a vascular fistula in the patient.