Transcatheter prosthetic heart valve delivery device with partial deployment and release features and methods

• US 8,926,692 B2
• Filed: 04/09/2010
• Issued: 01/06/2015
• Est. Priority Date: 04/09/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Dwork, Joshua
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US12/757,088
• Publication Number:
  US 20110251675A1
• Time in Patent Office: 1,733 Days
• Field of Search: 606/108, 606/191, 606/194, 606/198, 606/200, 623/1.11, 623/2.1, 623/2.11, 623/2.12
• US Class Current: 623/2.11
• 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: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A delivery device for percutaneously deploying a stented prosthetic heart valve, including a delivery sheath, an inner shaft, and a spindle. The inner shaft is slidably disposed within a lumen of the delivery sheath. The spindle is attached to the shaft and includes a hub defining at least one longitudinal slot sized to slidably receive a post of the stented valve. An outer surface of the hub forms a curved proximal segment. The device provides a loaded state in which the delivery sheath retains the stented valve over the inner shaft and coupled to the spindle via the slot. In a deployed state, the distal end of the delivery sheath is withdrawn from the prosthesis to permit the stented valve to release from the slot, sliding along the curved outer surface of the hub.

Claims

1. A delivery device for percutaneously deploying a stented prosthetic heart valve including a stent frame to which a valve structure is attached, the device comprising:

a delivery sheath assembly terminating at a distal end and defining a lumen;

an inner shaft slidably disposed within the lumen; and

a spindle attached to the shaft, the spindle including;

a tubular base,

a hub projecting radially outwardly relative to the base, wherein;

the hub defines at least one longitudinal slot sized to slidably receive a corresponding post of a prosthetic heart valve stent frame, wherein the at least one longitudinal slot is defined by opposing side walls and a floor, and further wherein the tubular base includes a ring immediately proximal the hub, the ring having a surface aligned with the floor,

an outer surface of the hub forms a proximal segment and a distal segment, the proximal segment being curved in extension toward the distal segment and defining a ramp-like face immediately adjacent the base, the distal segment defining a distal face, wherein the at least one longitudinal slot is open at the proximal and distal faces;

wherein the device is configured to provide a loaded state in which the delivery sheath assembly retains a stented prosthetic heart valve over the inner shaft and coupled to the spindle via the at least one slot, and a deployment state in which the distal end of the delivery sheath assembly is withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to release from the at least one longitudinal slot.

2. The delivery device of claim 1, wherein the at least one longitudinal slot includes a plurality of circumferentially spaced longitudinal slots formed in the hub.

3. The delivery device of claim 2, wherein the plurality of longitudinal slots are equidistantly spaced from one another about a circumference of the hub.

4. The delivery device of claim 1, wherein the spindle further includes a flange projecting radially outwardly relative to the base and proximally spaced from the hub by the ring.

5. The delivery device of claim 4, wherein an outer diameter of the flange approximates a maximum outer diameter of the hub.

6. The delivery device of claim 1, wherein the outer surface defines a convex curve in longitudinal extension along the proximal segment.

7. The delivery device of claim 1, wherein the outer surface, as collectively defined by the proximal and distal segments, approximates a semi-circle in longitudinal extension.

8. The delivery device of claim 1, further comprising:

a release sheath assembly disposed between the delivery sheath assembly and the spindle in the loaded state, the release sheath assembly including a release sheath slidably received over at least the proximal segment of the hub in the loaded state.

9. The delivery device of claim 8, wherein the release sheath assembly is configured to proximally retract the release sheath relative to the hub with proximal retraction of the delivery sheath distal end from the release sheath.

10. The delivery device of claim 8, wherein the release sheath forms at least one longitudinal notch extending from a distal end of the release sheath, and further wherein upon final assembly in the loaded state, the at least one notch is longitudinally aligned with the at least one slot.

11. The delivery device of claim 10, wherein the at least one longitudinal slot includes a plurality of circumferentially spaced longitudinal slots, and the at least one notch includes a plurality of circumferentially spaced notches, and further wherein each of the slots is longitudinally aligned with a respective one of the notches.

12. The delivery device of claim 11, wherein the spindle further forms a circumferential trough between the hub and a flange formed proximal the hub, and further wherein the release sheath includes a plurality of fingers spaced from one another by the plurality of notches, and further wherein the loaded state includes the fingers extending across the circumferential trough.

13. A system for repairing a defective heart valve of a patient, the system comprising:

a prosthetic heart valve having a stent frame and a valve structure attached to the stent frame, the stent frame defining a distal region and a proximal region, the proximal region forming at least one post; and

a delivery device comprising;

a delivery sheath assembly terminating at a distal end and defining a lumen,

an inner shaft slidably disposed within the lumen,

a spindle attached to the inner shaft, the spindle including;

a tubular base,

a hub projecting radially outwardly relative to the base and defining at least one longitudinal slot sized to slidably receive the at least one post, wherein the outer surface of the hub forms a proximal segment and a distal segment, the proximal segment being curvilinear to define a convex curve in extension toward the distal segment and a ramp-like proximal face in extension toward the base, the distal segment defining a distal face, wherein the at least one longitudinal slot is open at the proximal and distal faces;

wherein the system is configured to provide a loaded condition in which the prosthetic heart valve is retained between the delivery sheath assembly and the inner shaft, including the at least one post slidably captured within the at least one longitudinal slot.

14. The system of claim 13, wherein the at least one longitudinal slot includes a plurality of circumferentially spaced longitudinal slots, and further wherein the at least one post includes a plurality of posts corresponding with the plurality of longitudinal slots.

15. The system of claim 13, wherein the spindle further includes a flange projecting radially outwardly relative to the base and proximally spaced from the hub to define a circumferential trough.

16. The system of claim 15, wherein the at least one post includes a distal shoulder and a proximal head, the shoulder sized to slidably nest within the longitudinal slot and the head sized to slidably nest within the trough.

17. The system of claim 16, wherein a circumferential width of the head is larger than a circumferential width of the shoulder.

18. The system of claim 17, wherein the shoulder and the head collectively define a T-like shape.

19. The system of claim 13, wherein the system is further configured to provide a deployment condition in which the distal end of the delivery sheath assembly is proximal the hub to permit the at least one post to release from the at least one slot, including a head of the at least one post sliding along the curved proximal segment of the hub outer surface.

20. The system of claim 19, wherein the stent frame is configured to radially self-expand from a compressed arrangement to a normal arrangement, and further wherein the loaded condition includes the delivery sheath assembly compressively retaining the prosthetic heart valve in the compressed arrangement.

21. The system of claim 20, wherein the deployment condition includes the stent frame self-expanding to the normal arrangement.

22. The system of claim 13, wherein the delivery device further includes:

a release sheath assembly disposed between the delivery sheath assembly and the spindle in the loaded state, the release sheath assembly including a release sheath slidably received over at least the proximal segment of the hub in the loaded state.

23. The system of claim 22, wherein the release sheath forms at least one longitudinal notch extending from a distal end of the release sheath, and further wherein upon final assembly in the loaded condition, the at least one notch is longitudinally aligned with the at least one slot.

24. The system of claim 23, wherein the system is further configured to provide a deployment condition, including the release sheath proximally retracted from the hub and the at least one post self-pivoting through the at least one slot and the at least one notch.

25. The system of claim 24, wherein the at least one post includes a distal shoulder and a proximal head, and further wherein the spindle forms a circumferential trough proximal the hub such that the loaded condition includes the shoulder disposed within the at least one slot and the head disposed within the trough, the head being releasably captured within the trough by the release sheath.

26. A method of percutaneously deploying a stented prosthetic heart valve to an implantation site of a patient, the method comprising:

receiving a delivery device loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath assembly containing the prosthetic heart valve in a compressed arrangement over an inner shaft in a loaded state of the device, and a spindle attached to the shaft, the spindle including;

a tubular base,

a hub projecting radially outwardly relative to the base and defining at least one longitudinal slot and an outer surface forming a proximal segment and a distal segment, the proximal segment being curved in extension toward the distal segment and defining a ramp-like proximal face immediately adjacent the base, the distal segment defining a distal face, wherein the at least one longitudinal slot is open at the proximal and distal faces,

wherein a post of the stent frame is slidably captured within the at least one longitudinal slot in the loaded state;

delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient and to the implantation site via the delivery device in the loaded state;

proximally retracting the delivery sheath assembly from the prosthetic heart valve; and

permitting the post to release from the at least one longitudinal slot, including a surface of the post sliding along the curved proximal segment of the hub outer surface such that the prosthetic heart valve deploys from the delivery device.

27. The method of claim 26, wherein the at least one longitudinal slot includes a plurality of circumferentially spaced longitudinal slots, and further wherein the post includes a plurality of posts corresponding with the plurality of longitudinal slots.

28. The method of claim 26, wherein the stent frame is configured to radially self-expand from a compressed arrangement to a normal arrangement, and further wherein the loaded state includes the delivery sheath assembly compressively retaining the prosthetic heart valve in the compressed arrangement.

29. The method of claim 26, wherein the delivery device further includes:

a release sheath assembly disposed between the delivery sheath assembly and the spindle in the loaded state, the release sheath assembly including a release sheath slidably received over at least the proximal segment of the hub.

30. The method of claim 29, wherein the release sheath forms at least one longitudinal notch extending from a distal end of the release sheath, and further wherein permitting the post to release from the at least one longitudinal slot includes the post pivoting relative to the spindle such that a portion of the post moves through the at least one longitudinal slot and a corresponding one of the at least one notch.