Force-based heart valve sizer

• US 9,277,996 B2
• Filed: 08/27/2013
• Issued: 03/08/2016
• Est. Priority Date: 12/09/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S., Chang, Da-Yu
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US14/011,602
• Publication Number:
  US 20130345801A1
• Time in Patent Office: 924 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/066 for measuring torque
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A valve sizer for determining an appropriate replacement valve size when performing a heart valve replacement procedure is provided. In one version the valve sizer has a hollow shaft with proximal and distal ends. A movable sizing element couples to the distal end of the shaft and is radially expandable between first, contracted and second, expanded positions. An actuator assembly on a handle includes an actuator coupled to a clutch member via a ball-spring-detent clutch. A rod extends through the shaft and maintains a fixed distance between the handle and a distal hub in the sizing element. Movement of the actuator causes axial movement of the shaft, thereby causing radial expansion of sizing petals relative to the hub. The clutch slips when a predetermined reaction force from the surrounding valve annulus is met by the petals.

Claims

1. A heart valve sizer for determining an appropriate replacement prosthetic heart valve size when performing a valve replacement procedure comprising:

a proximal handle having an actuator comprising an actuator ring mounted for rotation about the handle;

a shaft extending distally from the proximal handle and having a movable member and a stationary member;

a sizing element coupled to the distal end of the shaft, the sizing element having a hub and a plurality of petals each radially movable between a first retracted position and a second expanded position, the hub being fixed to the stationary member in the shaft and the petals being connected to expand radially upon displacement of the movable member in the shaft; and

a clutch mechanism in the proximal handle connected between the actuator and the movable member in the shaft so as to transmit movement forces therebetween, the clutch mechanism including a clutch ring rotatably coupled to the actuator ring via a plurality of bearings movable with the clutch ring and biased by springs into detents in the actuator ring, wherein rotation of the actuator ring causes displacement of the movable member via the clutch ring and consequently outward radial expansion of the petals in the sizing element into contact with a surrounding heart valve annulus, wherein the clutch mechanism slips at a predetermined desired reaction force imparted by the heart valve annulus against further outward radial expansion of the petals.

2. The valve sizer of claim 1, wherein the shaft comprises a rod extending through a hollow shaft, where the rod is the stationary member fixed with respect to both the handle and the hub, and the hollow shaft is the movable member and is fixed with respect to the clutch ring, and wherein the clutch ring is connected via a screw thread to the handle so that rotation of the clutch ring causes axial movement of the clutch ring and hollow shaft relative to the handle.

3. The valve sizer of claim 1, wherein the plurality of bearings and the springs are cantilevered fingers distributed around the clutch ring and the detents are formed on an inner surface of the actuator ring.

4. The valve sizer of claim 3, wherein the plurality of bearings and the springs are held within the clutch ring and the detents are formed on an inner surface of the actuator ring.

5. The valve sizer of claim 1, wherein the plurality of petals move in a plane substantially perpendicular to a longitudinal axis defined by the shaft.

6. The valve sizer of claim 5, wherein the movable member moves axially along the shaft and contacts and pivots a lever for each of the petals, wherein pivoting of the levers causes radial expansion of the petals.

7. The valve sizer of claim 5, wherein the movable member moves axially along the shaft and connects to a camming member that directly contacts and causes radial expansion of the petals.

8. The valve sizer of claim 1, wherein the plurality of petals defines a cylindrical annulus portion and an outwardly-extending flange on a proximal end of the cylindrical annulus portion.

9. The valve sizer of claim 8, wherein the outwardly-extending flange has an axially undulating peripheral shape.

10. The valve sizer of claim 1, wherein the sizer is configured for percutaneous delivery through a catheter and the petals in their first retracted position limit the diameter of the sizing element to be small enough to enable passage through the catheter, and wherein the petals remain parallel to an axis of the hub while being displaced outward.

11. The valve sizer of claim 1, wherein the handle also includes a window at one circumferential location and the clutch ring has a number of numerical markings thereon indicating different sizes of replacement prosthetic heart valves, the numerical markings being sized and aligned to show one at a time through the window on the handle upon rotation of the clutch ring relative to the handle such that a desired valve size shows through the window when the clutch mechanism slips.

12. A surgical heart valve sizer for determining an appropriate replacement prosthetic heart valve size when performing a valve replacement procedure, the replacement prosthetic heart valves having a range of specific sizes comprising:

a proximal handle having an actuator comprising an actuator ring mounted for rotation about the handle, the handle also including a window at one circumferential location;

a shaft extending distally from the handle;

a surgical sizing element coupled to a distal end of the shaft, the sizing element having a radially variable size controlled by movement of at least a portion of the shaft; and

a clutch mechanism in the proximal handle configured to transmit rotation of the actuator ring to a clutch ring which in turn moves the portion of the shaft that controls the size of the sizing element, the clutch ring having a number of numerical markings thereon indicating different sizes of replacement prosthetic heart valves, the numerical markings being sized and aligned to show one at a time through the window on the handle upon rotation of the clutch ring relative to the handle, wherein the sizing element and clutch mechanism are coupled together such that outward radial expansion of the sizing element into contact with a surrounding heart valve annulus transmits via the shaft a reaction force back to the clutch mechanism which slips at a predetermined desired reaction force to halt further outward radial expansion of the sizing element, and wherein a desired valve size shows through the window when the clutch mechanism slips.

13. The surgical sizer of claim 12, wherein the shaft comprises a rod extending through a hollow shaft, where the rod is fixed with respect to both the handle and a central hub of the sizing element, and the hollow shaft is fixed with respect to the clutch ring, and wherein the clutch ring is connected via a screw thread to the handle so that rotation of the clutch ring causes axial movement of the clutch ring and hollow shaft relative to the handle.

14. The surgical sizer of claim 12, wherein the clutch mechanism comprises a plurality of bearings biased by springs into detents.

15. The surgical sizer of claim 14, wherein the plurality of bearings and the springs are held within the clutch ring and the detents are formed on an inner surface of the actuator ring.

16. The surgical sizer of claim 14, wherein the plurality of bearings and the springs are cantilevered fingers distributed around the clutch ring and the detents are formed on an inner surface of the actuator ring.

17. The surgical sizer of claim 12, wherein the sizing element comprises a central hub and a plurality of petals each radially movable between a first retracted position and a second expanded position.

18. The surgical sizer of claim 17, wherein the shaft has a movable member and a stationary member, and the movable member moves axially along the shaft and contacts and pivots a lever for each of the petals, wherein pivoting of the levers causes radial expansion of the petals.

19. The surgical sizer of claim 18, wherein the movable member connects to a camming member that directly contacts and causes radial expansion of the petals.

20. The surgical sizer of claim 17, wherein the plurality of petals defines a cylindrical annulus portion and an outwardly-extending flange on a proximal end of the cylindrical annulus portion.

21. The surgical sizer of claim 12, wherein the sizer is configured for percutaneous delivery through a catheter and the sizing element in a first retracted position has a diameter small enough to enable passage through the catheter.