DELIVERY DEVICE FOR PROSTHETIC HEART VALVE WITH CAPSULE ADJUSTMENT DEVICE

• US 20160262883A1
• Filed: 03/13/2015
• Published: 09/15/2016
• Est. Priority Date: 03/13/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Sandstrom, Jeffrey
• Granted Patent: US 10,758,349 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

Abstract

A delivery device for percutaneously delivering a stented prosthetic heart includes a sheath, a handle, and adjustment device including a fine adjustment mechanism, and an outer stability shaft. The sheath defines a lumen and is configured to compressively constrain the stented prosthetic heart valve. The handle is coupled to the proximal portion of the sheath and includes an actuator mechanism coupled to a proximal portion of the sheath that is configured to selectively move the sheath relative to the housing to release the stented prosthetic heat valve. The adjustment device is coupled to the handle and includes an adjustment lumen through which the sheath and the handle slidably extend. The outer stability shaft is coupled to the adjustment device. The fine adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft.

Claims

1. A delivery device for percutaneously delivering a stented prosthetic heart valve, the stented prosthetic heart valve being radially expandable from a radially compressed configuration to a radially expanded configuration, the delivery device comprising:

a sheath defining a lumen, wherein the sheath is configured to compressively constrain the stented prosthetic heart valve;

a handle including a housing and an actuator mechanism, wherein the actuator mechanism is coupled to a proximal portion of the sheath and is configured to selectively move the sheath relative to the housing to release the stented prosthetic heart valve;

an adjustment device coupled to the handle, wherein the adjustment device includes an adjustment lumen through which the sheath and the handle slidably extend, wherein the adjustment device includes a fine adjustment mechanism; and

an outer stability shaft coupled to the adjustment device, wherein the fine adjustment mechanism is configured to selectively move the handle and the shaft relative to the adjustment device and the outer stability shaft.

2. The delivery device of claim 1, wherein the fine adjustment mechanism includes a toothed wheel that is coupled to teeth on the handle.

3. The delivery device of claim 2, wherein the toothed wheel is oriented relative to a longitudinal axis of the adjustment device and the handle such that the toothed wheel rotates parallel to the longitudinal axis to move the handle and the shaft.

4. The delivery device of claim 2, further comprising a second toothed wheel disposed between the toothed wheel and the teeth on the handle, wherein the toothed wheel is coupled to the second toothed wheel and the second toothed wheel is coupled to the teeth on the handle.

5. The delivery device of claim 1, wherein the outer stability shaft is configured to isolate the sheath from a separate introducer valve component through which the delivery device is inserted into a patient.

6. The delivery device of claim 1, wherein the sheath comprises a distal capsule and a proximal shaft, wherein the proximal shaft is attached to an actuator mechanism of the handle, and wherein the distal capsule is configured to compressively constrain the stented prosthetic heart valve.

7. The delivery device of claim 6, wherein an outer diameter of the capsule is greater than an outer diameter of the proximal shaft, the proximal shaft being affixed to the capsule at a connection point, and further wherein in a delivery configuration, the connection point is distal of the distal end of the stability shaft by a distance in the range of 3-13 cm.

8. The delivery device of claim 6, wherein an outer diameter of the capsule is greater than an outer diameter of the proximal shaft, the capsule being affixed to the proximal shaft at a connection point, and further wherein in a deployed configuration, the connection point is distal of the distal end of the stability shaft.

9. The delivery device of claim 1, wherein the adjustment mechanism is configured to selectively move the handle and the sheath relative to the adjustment device and the outer stability shaft a distance in the range of 10-40 mm.

10. A method for restoring a defective heart valve in a patient, the method comprising the steps of:

manipulating a delivery device loaded with a radially expandable prosthetic heart valve in a radially compressed configuration, the prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath constraining the prosthetic heart valve in the radially compressed configuration, an outer stability shaft coaxially received over the delivery sheath and terminating proximal of the prosthetic heart valve with the delivery device in a delivery configuration, a handle including a housing and an actuator mechanism coupled to the delivery sheath, and an adjustment device coupled to the handle, to guide the prosthetic heart valve through the patient'"'"'s vasculature and into the defective heart valve by moving the handle, which correspondingly moves the adjustment device, delivery sheath, and stability shaft;

finely adjusting the location of the prosthetic heart valve by manipulating the fine adjustment mechanism on the adjustment device, wherein manipulating the fine adjustment mechanism causes the handle and the delivery sheath to move relative to the adjustment device and the outer stability shaft; and

withdrawing the delivery sheath from the prosthetic heart valve by actuating the actuator mechanism such that the delivery sheath slides relative to the outer stability shaft and the handle to release the prosthetic heart valve from the delivery sheath such that the prosthetic heart valve self-expands into engagement with the native heart valve.

11. The method of claim 10, wherein the step of withdrawing the delivery sheath includes the outer stability shaft isolating the delivery sheath from an introducer valve.

12. The method of claim 10, wherein the fine adjustment mechanism includes a toothed wheel that is coupled to teeth on the handle, wherein the step of finely adjusting the location of the prosthetic heart valve comprises rotating the toothed wheel to move the handle and the delivery sheath attached to the handle.

13. The method of claim 12, wherein the toothed wheel is oriented relative to the longitudinal axis of the adjustment device and the handle such that the toothed wheel rotates parallel to the longitudinal axis to move the handle and the delivery sheath.

14. The method of claim 12, further comprising a second toothed wheel disposed between the toothed wheel and the teeth on the handle, such that the step of adjusting the fine adjustment mechanism comprises rotating the toothed wheel which rotates the second toothed wheel, which moves the handle via the teeth on the handle.

15. The method of claim 10, wherein the delivery device further includes an inner shaft disposed within the delivery sheath such that the prosthetic heart valve is disposed between the inner shaft and the delivery sheath in the delivery configuration, wherein during the step of finely adjusting the location of the prosthetic heart valve the inner shaft moves with the handle and the deliver sheath relative to the adjustment device and the outer stability shaft.

16. The method of claim 15, wherein during the step of withdrawing the delivery sheath, the delivery sheath slides relative to the inner shaft.