Actively controllable stent, stent graft, heart valve and method of controlling same

• US 9,913,716 B2
• Filed: 01/24/2017
• Issued: 03/13/2018
• Est. Priority Date: 10/21/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Cartledge, Richard, Smith, Kevin W., Bales, Jr., Thomas O., Mendez, Max Pierre, Kline, Korey, Palmer, Matthew A., Kirk, Michael Walter, Rivera, Carlos, Deville, Derek Dee
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/414,239
• Publication Number:
  US 20170128198A1
• Time in Patent Office: 413 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• 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
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/006 : modular

Abstract

A delivery apparatus can include a handle portion and at least one rotatable drive shaft. The handle portion can have an actuation mechanism with a motor. The rotatable drive shaft can have a proximal end portion and a distal end portion. The proximal end portion of the rotatable drive shaft can be coupled to the motor, and the distal end portion of the rotatable drive shaft can be configured to be releasably coupled to a prosthetic heart valve. The actuation mechanism can be configured to control and monitor expansion of the prosthetic heart valve and to control and monitor torque of the motor.

Claims

1. A delivery apparatus, comprising:

a handle portion having an actuation mechanism, wherein the actuation mechanism includes a motor; and

at least one rotatable drive shaft having a proximal end portion and a distal end portion, wherein the proximal end portion is coupled to the motor, and the distal end portion is configured to be releasably coupled to a prosthetic heart valve,

wherein the actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve and to control and monitor torque of the motor.

2. The delivery apparatus of claim 1, wherein the actuation mechanism further comprises a torque limiting member configured to limit an electrical current of the motor.

3. The delivery apparatus of claim 1, wherein the actuation mechanism further comprises a clutch mechanism configured to limit the torque transmitted to the drive shaft from the motor.

4. The delivery apparatus of claim 1, wherein the actuation mechanism further comprises a gear assembly coupled to the motor and the drive shaft and configured to transfer rotational movement of the motor to the drive shaft.

5. The delivery apparatus of claim 4, wherein the at least one drive shaft is a plurality of drive shafts, the motor includes an output shaft having a first gear, and the gear assembly includes a second gear, a connecting shaft, a third gear, and a plurality of fourth gears, and wherein the first gear is coupled to the second gear, the second gear is coupled to a first end of the connecting shaft, the third gear is coupled to a second end of the connecting shaft, the third gears are coupled to the fourth gears, and the fourth gears are coupled to respective ones of the drive shafts.

6. The delivery apparatus of claim 5, wherein the actuation mechanism further comprises a clutch mechanism disposed between the first gear and the second gear, the clutch mechanism configured to limit the torque transmitted to the drive shafts from the motor.

7. The delivery apparatus of claim 1, wherein the handle portion further comprises a user interface with a display configured to display a diameter of the prosthetic heart valve.

8. The delivery apparatus of claim 7, wherein the display is further configured to display a comparison of the diameter of the prosthetic heart valve to a diameter of a patient'"'"'s native anatomy.

9. The delivery apparatus of claim 1, wherein the handle portion further comprises a user interface with a display configured to display when the prosthetic heart valve contacts a patient'"'"'s native anatomy.

10. The delivery apparatus of claim 1, wherein the handle portion further comprises a user interface with a display configured to display the magnitude of force imparted on the prosthetic heart valve by a patient'"'"'s native anatomy.

11. The delivery apparatus of claim 1, wherein the actuation mechanism is programmed to expand the prosthetic heart valve to a plurality of predetermined diameters upon actuating the actuation mechanism.

12. The delivery apparatus of claim 1, wherein one actuation of the actuation mechanism causes the prosthetic heart valve to expand to a first predetermined diameter that is at least 75% of a fully expanded diameter of the prosthetic heart valve, and another actuation of the actuation mechanism cause the prosthetic heart valve to expand from the first predetermined diameter to a second predetermined diameter that is 1 mm larger than the first predetermined diameter.

13. A delivery assembly, comprising:

a prosthetic heart valve having stent and a plurality of adjustable elements configured to radially expand and contract the stent; and

a delivery apparatus having a handle portion, first drive shaft, and a plurality of second drive shafts, wherein the handle portion has an actuation mechanism with a motor, the first drive shaft is coupled to the motor such that rotation of the motor causes rotation of the first drive shaft, first end portions of the second drive shafts are coupled to the first drive shaft such that rotation of the first shaft causes rotation of the second drive shafts, and second end portions of the second drive shafts are coupled to the adjustable elements of the prosthetic heart valve such that rotation of the second drive shafts causes movement of the adjustable elements to effect radial expansion or contraction of the prosthetic heart valve.

14. A delivery assembly, comprising:

a prosthetic heart valve having stent and a plurality of adjustable elements configured to radially expand and contract the stent; and

a delivery apparatus having a handle portion, first drive shaft, and a plurality of second drive shafts, wherein the handle portion has an actuation mechanism with a motor, the first drive shaft is coupled to the motor such that rotation of the motor causes rotation of the first drive shaft, first end portions of the second drive shafts are coupled to the first drive shaft such that rotation of the first shaft causes rotation of the second drive shafts, and second end portions of the second drive shafts are coupled to the adjustable elements of the prosthetic heart valve such that rotation of the second drive shafts causes movement of the adjustable elements to effect radial expansion or contraction of the prosthetic heart valve,

wherein actuating the actuation mechanism expands and contracts the prosthetic heart valve, and wherein the actuation mechanism is configured to control and monitor expansion of the prosthetic heart valve and to control and monitor torque applied to the prosthetic heart valve by the motor.

15. The delivery assembly of claim 14, wherein the handle portion further comprises at least one sensor and a user interface with a force feedback indicator, the at least one sensor configured to measure a force imparted on the prosthetic heart valve by a patient'"'"'s native anatomy, and the force feedback indicator configured to display the force measured by the at least one sensor.

16. The delivery assembly of claim 15, wherein the at least one sensor is configured to measure the force by measuring resistance to the motor, and the force feedback indicator is configured to display a graphical change of the resistance to the motor.

17. The delivery assembly of claim 14, wherein the handle portion further comprises a torque meter configured to measure the torque of the motor, and the user interface is configured to display the torque measured by the torque meter.

18. The delivery assembly of claim 14, wherein the actuation mechanism comprises a mechanical slip clutch.

19. The delivery assembly of claim 14, wherein the handle portion further comprises a user interface configured to display a real-time diameter of the prosthetic heart valve.

20. The delivery assembly of claim 14, wherein the actuation mechanism further comprises a torque limiting member configured to limit the torque of the motor.

21. The delivery assembly of claim 14, wherein the actuation mechanism is configured such that actuating the actuation mechanism causes the prosthetic heart valve to expand to a predetermined diameter.

22. The delivery assembly of claim 14, wherein the stent comprises a plurality of lumens having internal threads formed therein, and wherein the adjustable elements comprise a plurality of drive screws having external threads formed thereon and configured to threadably engage the internal threads of the lumens.

23. The delivery assembly of claim 22, wherein the lumens are defined in struts of the stent.

24. The delivery assembly of claim 22, wherein the stent is at least partially self-expanding.