VALVE DELIVERY DEVICE WITH A PIEZOCHROMATIC FEEDBACK INDICATOR AND METHODS OF USE

• US 20170165063A1
• Filed: 10/26/2016
• Published: 06/15/2017
• Est. Priority Date: 12/09/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Griffin, Patrick, Anderson, Marc, Hopkins, Caroline
• Granted Patent: US 10,357,362 B2
• Time in Patent Office: Days
• 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 2210/00 Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2250/009 for single use, e.g. having means for preventing re-use
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

Heart valve delivery systems and methods for providing a clinician with feedback during a stented prosthetic heart valve delivery procedure. Feedback is provided using piezochromatic indicators incorporated into elements of the delivery device, such as the handle assembly, shaft assembly and capsule to indicate when detrimental forces, or forces nearing those that are detrimental, are being applied to the delivery device during the prosthetic heart valve loading, delivery or deployment procedure. Other embodiments incorporate a feedback indicator to indicate that a delivery device has previously been used and is not in a new condition.

Claims

1. A delivery device for implanting a stented prosthetic heart valve, the delivery device comprising:

an inner shaft assembly configured for temporary connection with the stented prosthetic heart valve in a loaded state;

a delivery sheath assembly having an outer sheath that is co-axially received over the inner shaft assembly and including a capsule configured to contain the stented prosthetic heart valve in the loaded state;

a handle assembly interconnected to the delivery sheath assembly; and

a piezochromatic feedback indicator incorporated into the delivery device.

2. The delivery device of claim 1, wherein the handle assembly includes an actuation mechanism for controlling movement of the capsule.

3. The delivery device of claim 2, wherein at least part of a force provided by the actuation mechanism is translated to the piezochromatic feedback indicator.

4. The delivery device of claim 1, wherein the feedback indicator is positioned in the handle assembly;

wherein the feedback indicator visually indicates a level of force exerted on a drive screw element of the handle assembly.

5. The delivery device of claim 1, wherein the feedback indicator is positioned on the outer sheath and visually indicates a level of strain from stretching of the outer sheath.

6. The delivery device of claim 1, wherein the feedback indicator is incorporated into the capsule and visually indicates pressure that the prosthetic heart valve is placing on the capsule.

7. The delivery device of claim 1, wherein the piezochromatic feedback indicator includes revisable piezochromatic pigments in that the piezochromatic pigments will change color upon the application of pressure and return to the pigment'"'"'s original color when the pressure is relieved.

8. The delivery device of claim 1, wherein the piezochromatic feedback indicator includes irreversible piezochromatic pigments;

in that the irreversible piezochromatic pigments will change color upon the application of pressure and will not return to the pigment'"'"'s original color when the pressure is relieved.

9. The delivery device of claim 8, wherein the piezochromatic feedback indicator is arranged and configured to indicate whether the delivery device has been used.

10. The delivery device of claim 1, further comprising a plurality of piezochromatic feedback indicators;

wherein the plurality of feedback indicators are separate and distinct components of the delivery device.

11. The delivery device of claim 1, further comprising a plurality of piezochromatic feedback indicators;

wherein the plurality of piezochromatic feedback indicators includes at least two of;

a first feedback indicator including a reversible piezochromatic pigment, a second feedback indicator including a memory piezochromatic pigment and a third feedback indicator including an irreversible piezochromatic pigment.

12. The delivery device of claim 1, wherein the piezochromatic feedback indicator is dispersed within one of a first material of the handle;

a second material of the outer sheath and a third material of the capsule.

13. A delivery device for implanting a stented prosthetic heart valve, the delivery device comprising:

an inner shaft assembly configured for temporary connection with the stented prosthetic heart valve in a loaded state;

a delivery sheath assembly configured to contain the stented prosthetic heart valve in the loaded state;

a handle assembly interconnected to the delivery sheath assembly, the handle including an actuation mechanism for controlling movement of the outer sheath assembly; and

a piezochromatic feedback indicator proximate the actuating mechanism;

wherein at least part of a force provided by the actuation mechanism is translated to the piezochromatic feedback indicator.

14. A method of visually indicating a level of force being applied to a transcatheter valve delivery device, the method including the step of:

providing a transcatheter valve delivery device including a feedback indicator including piezochromatic pigments;

wherein the feedback indicator is arranged and configured to change colors when the piezochromatic pigments are subjected to a predetermined level of force; and

visually monitoring the feedback indicator for a change in color.

15. The method of claim 14, wherein the delivery device includes:

an inner shaft assembly configured for temporary connection with the stented prosthetic heart valve in a loaded state;

a delivery sheath assembly having an outer sheath that is co-axially received over the inner shaft assembly and including a capsule configured to contain the stented prosthetic heart valve in the loaded state; and

a handle assembly.

16. The method of claim 15, wherein the feedback indicator is positioned in the handle assembly.

17. The method of claim 15, wherein the feedback indicator is positioned in the outer shaft.

18. The method of claim 15, wherein the feedback indicator is incorporated into the capsule.

19. The method of claim 18, further comprising the step of providing a prosthetic heart valve;

wherein the step of visually monitoring the feedback indicator is conducted while loading the prosthetic heart valve within the capsule.

20. The method of claim 19, wherein the feedback indicator is positioned at a distal end of the capsule.