HINGED TRANSCATHETER PROSTHETIC HEART VALVE DELIVERY SYSTEM

• US 20150297346A1
• Filed: 04/08/2015
• Published: 10/22/2015
• Est. Priority Date: 04/17/2014
• Status: Active Grant

• Current Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Original Assignee: Medtronic Vascular Galway Limited (Medtronic Plc)
• Inventors: Duffy, Niall, Creaven, Marian
• Granted Patent: US 10,368,989 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A machined or molded hinge design, for use with a delivery device, which allows for controlled deflection of a large diameter catheter. With embodiments in which the delivery device is employed to implant a prosthetic heart valve, deflection of the catheter allows for central alignment of the delivery system in the native annulus during deployment of the bioprosthesis.

Claims

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

an outer sheath;

an inner shaft disposed within the outer sheath;

a deflection assembly attached to the inner shaft and including;

a plurality of stacked hinge segments, including a proximal-most hinge segment and a distal-most hinge segment, wherein each of the hinge segments are discretely formed as a solid body, and have complimentary engagement features by which immediately adjacent ones of the hinge segments interface with, and can articulate relative to, one another,

a joiner hub connected to the inner shaft and interfacing with the proximal-most hinge segment,

a leading hub interfacing with the distal-most hinge segment; and

a support shaft attached to and extending distally from the leading hub;

wherein the delivery device is configured to provide a loaded state in which a stented prosthetic heart valve is compressed over the support shaft and retained within a capsule of the outer sheath;

and further wherein a hinge region of the deflection assembly is configured to be deflected by a user to change a spatial orientation of the support shaft relative to the inner shaft while the delivery device is in the loaded state.

2. The delivery device of claim 1, wherein the complimentary engagement features include a first tab and a first groove.

3. The delivery device of claim 2, wherein each of the hinge segments defines opposing, first and second major surfaces, and further wherein the first tab is formed as a projection along the first major surface and the first groove is formed as a recess in the second major surface.

4. The delivery device of claim 2, wherein the plurality of stacked hinge segments further includes first and second intermediate hinge segments, and further wherein the first tab of the first intermediate hinge segment is nested within the first groove of the second intermediate hinge segment.

5. The delivery device of claim 2, wherein the first groove is open to a side of the corresponding hinge segment.

6. The delivery device of claim 2, wherein the complimentary engagement features further include a second tab and a second groove.

7. The delivery device of claim 6, wherein each of the hinge segments defines opposing, first and second major surfaces, and further wherein the first and second tabs are formed as projections along the first major surface, and the first and second grooves are formed as recesses in the second major surface.

8. The delivery device of claim 7, wherein the plurality of stacked hinge segments further includes first and second intermediate hinge segments, and further wherein the first and second tabs of the first intermediate hinge segment are nested within the first and second grooves, respectively of the second intermediate hinge segment.

9. The delivery device of claim 1, wherein each of the stacked hinge segments, the joiner hub and the leading hub define a central bore for slidably receiving a guide wire.

10. The delivery device of claim 9, further comprising a pull wire attached to the leading hub and extending through each of the hinge segments and the joiner hub apart from the corresponding central bore.

11. The delivery device of claim 1, wherein the proximal-most hinge segment is pivotably attached to the joiner hub by at least a first pin.

12. The delivery device of claim 1, further comprising a first wire having opposing, first and second ends, wherein the wire extends through each of the hinge segments, and further wherein the first end is attached to the leading hub and the second end is attached to the joiner hub.

13. The delivery device of claim 1, wherein the deflection assembly is configured to be repeatedly translated between a linear arrangement and a deflected arrangement, and further wherein the linear arrangement includes a clearance gap being defined between immediately adjacent ones of the hinge segments at one side thereof.

14. The delivery device of claim 1, wherein the leading hub includes a valve retainer.

15. The delivery device of claim 14, wherein the valve retainer includes a first slot configured to receive a portion of a stent of a prosthetic heart valve.

16. A system for treating a defective heart valve, the system comprising:

a delivery device comprising;

an outer sheath,

an inner shaft disposed within the outer sheath,

a deflection assembly attached to the inner shaft and including;

a plurality of stacked hinge segments, including a proximal-most hinge segment and a distal-most hinge segment, wherein each of the hinge segments are discretely formed as a solid body, and have complimentary engagement features by which immediately adjacent ones of the hinge segments interface with, and can articulate relative to, one another,

a joiner hub connected to the inner shaft and interfacing with the proximal-most hinge segment,

a leading hub interfacing with the distal-most hinge segment, and

a support shaft attached to and extending distally from the leading hub,

wherein a hinge region of the deflection assembly is configured to be deflected by a user to change a spatial orientation of the support shaft relative to the inner shaft while the delivery device is in a loaded state; and

a prosthetic heart valve compressed over the support shaft and retained within a capsule of the outer sheath in the loaded state.

17. The system of claim 16, further comprising:

a guide wire slidably received within a central bore of each of the hinge segments, the joiner hub and the leading hub.

18. The system of claim 16, wherein the prosthetic heart valve is selectively secured to a valve retainer of the leading hub in the loaded state.

19. The system of claim 18, wherein the prosthetic heart valve includes a stent frame, and further wherein the valve retainer includes a slot sized to selectively receive a portion of the stent frame.

20. The system of claim 16, wherein the complimentary engagement features include a first tab and a first groove.