Methods and Devices for Cardiac Valve Repair or Replacement

• US 20110270276A1
• Filed: 04/30/2010
• Published: 11/03/2011
• Est. Priority Date: 04/30/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul T., Quill, Jason
• Granted Patent: US 8,974,475 B2
• Time in Patent Office: Days
• US Class Current: 606/143
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A delivery system for percutaneously guiding a repair or replacement device into a desired position relative to a valve within a patient. The delivery system includes a longitudinal support tube having a distal end, a deformable centering loop extending from the distal end of the support tube, at least one stop positioned on the centering loop and spaced from the distal end of the support tube, at least one clip delivery system slideably attached to the centering loop, and a sheath that is longitudinally slideable relative to the support tube, the centering loop, and the at least one clip delivery tube.

Claims

1. A delivery system for percutaneously delivering and attaching at least one clip and attached suture in a desired position within a patient, the delivery system comprising:

a longitudinal support tube having a distal end;

a deformable centering loop extending from the distal end of the support tube;

at least one stop positioned on the centering loop and spaced from the distal end of the support tube;

at least one clip delivery system slideably attached to the centering loop; and

a sheath that is longitudinally slideable relative to the support tube, the centering loop, and the at least one clip delivery tube.

2. The delivery system of claim 1, wherein the centering loop comprises a shape memory material.

3. The delivery system of claim 1, wherein each clip delivery system comprises a clip delivery tube comprising a distal end and a linking member attached to the clip delivery tube adjacent to its distal end, wherein the linking member is slideable along the centering loop.

4. The delivery system of claim 3, wherein each linking member is slideable along the centering loop from the distal end of the support tube to one of the stops.

5. The delivery system of claim 1, wherein each clip delivery system comprises a clip delivery tube having a central opening.

6. The delivery system of claim 5, in combination with at least one clip and a suture extending from the clip, wherein each clip and suture is positionable within the central opening of the clip delivery tube.

7. The delivery system of claim 6, wherein at least one of the clips comprises a shape memory material.

8. The delivery system of claim 6, wherein at least one of the clips comprises a coiled shape.

9. The delivery system of claim 6, wherein at least one of the clips comprises a tissue-piercing distal end.

10. The delivery system of claim 6, further comprising a clip pusher slideably positioned within the central opening of the clip delivery tube.

11. The delivery system of claim 10, further comprising a shoulder portion located between each clip and suture, wherein the shoulder portion is engageable with a distal end of the clip pusher.

12. The delivery system of claim 11, wherein the shoulder portion comprises a crimp sleeve.

13. A method for percutaneously guiding a repair or replacement device into a desired position relative to tissue that is adjacent to a valve within a patient, the method comprising the steps of:

providing a loaded delivery system comprising;

a longitudinal support tube having a distal end;

a deformable centering loop in a compressed condition and extending from the distal end of the support tube;

at least one stop positioned on the centering loop and spaced from the distal end of the support tube;

at least one clip delivery system slideably attached to the centering loop;

a sheath enclosing the support tube, the centering loop, and the at least one clip delivery system; and

a clip positioned within each of the clip delivery systems;

percutaneously delivering the distal end of the delivery system to a desired position relative to a valve in a patient;

retracting the sheath in a proximal direction to expose the centering loop and allow it to expand outwardly relative to a distal end of the sheath;

deploying each of the clips into the tissue of the patient, wherein a suture is attached to each of the clips;

removing the centering loop, the clip delivery system, and the sheath from the patient;

guiding a repair or replacement device along the sutures into a desired location within the patient.

14. The method of claim 13, further comprising the step of removing the clips and sutures from the patient after guiding the repair or replacement device into its desired location.

15. The method of claim 13, further comprising the step of inserting a guide wire into the patient prior to the step of percutaneously delivering the delivery system.

16. The method of claim 13, wherein the centering loop comprises a shape memory material.

17. The method of claim 13, wherein the step of deploying each of the clips comprises forcing each of the clips from a distal end of its respective clip delivery system and into the tissue of the patient.

18. The method of claim 17, wherein each clip delivery system comprises:

a clip delivery tube having a central opening, and

a clip pusher positioned within the central opening of the clip delivery tube;

and wherein the step of deploying the clips further comprises sliding the clip pusher in a distal direction.

19. The method of claim 13, wherein at least one of the clips comprises a shape memory material.

20. The method of claim 13, wherein each clip delivery system comprises clip delivery tube comprising a distal end and a linking member attached to the clip delivery tube adjacent to its distal end, wherein the linking member is slideable along the centering loop.