Force-based heart valve sizer

• US 9,345,574 B2
• Filed: 12/06/2012
• Issued: 05/24/2016
• Est. Priority Date: 12/09/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/707,395
• Publication Number:
  US 20130150954A1
• Time in Patent Office: 1,265 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 2090/068 with a bubble level
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• 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
• CPC Class Codes: A61F 2250/0073 Force-limiting means

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 method of sizing a patient'"'"'s cardiac valve annulus, comprising:

providing a valve sizer having a shaft with a proximal end and a distal end and an expandable sizing element coupled to the distal end of the shaft, the sizing element being radially expandable between a first retracted position and a second expanded position, the valve sizer further having an actuator assembly comprising an actuator that moves relative to a handle, a clutch ring mounted at the proximal end of the shaft and coupled for rotation to the actuator via a clutch mechanism, and a stationary rod extending through at least a portion of the shaft, wherein the shaft is connected to the clutch ring so that movement of the actuator transmits through the clutch mechanism to the clutch ring and shaft and causes axial movement of the shaft, wherein the axial movement of the shaft causes radial expansion of the sizing element, wherein the actuator comprises an actuator ring and the sizing element includes a central hub, where the stationary rod is fixed with respect to both the handle and the central hub, and wherein the clutch ring is connected via a screw thread to the handle so that rotation of the clutch ring causes axial movement thereof and of the shaft;

inserting the valve sizer in the first retracted position into the patient so that the sizing element is positioned within the valve annulus; and

rotating the handle until the clutch mechanism of the actuator assembly begins to slip indicating that the sizer has applied a desired outward force to the annulus.

2. The method of claim 1, wherein the clutch mechanism comprises a plurality of bearings biased by springs into detents.

3. The method of claim 2, 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.

4. The method of claim 1, wherein the sizing element includes a plurality of sizing petals radially expandable between the first and second positions.

5. The method of claim 4, wherein the plurality of sizing petals move in a plane substantially perpendicular to a longitudinal axis defined by the shaft.

6. The method of claim 4, wherein the shaft moves axially and contacts and pivots a lever for each of the petals, wherein pivoting of the levers causes radial expansion of the petals.

7. The method of claim 4, wherein the shaft moves axially and connects to a camming member that directly contacts and causes radial expansion of the petals.

8. The method of claim 4, 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 method of claim 8, wherein the outwardly-extending flange has an axially undulating peripheral shape.

10. A method of sizing a patient'"'"'s anatomical orifice, comprising:

providing a valve sizer having;

a proximal handle having an actuator;

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 movement from the actuator to the portion of the shaft that controls the size of the sizing element, wherein the sizing element and clutch mechanism are coupled together such that outward radial expansion of the sizing element into contact with a surrounding orifice transmits via the shaft a reaction force back to the clutch mechanism which slips at a predetermined reaction force corresponding to a desired outward force applied by the sizing element to the orifice and halts further outward radial expansion of the sizing element, wherein the shaft comprises a rod extending through a hollow shaft and the actuator comprises an actuator ring, where the rod is fixed with respect to both the handle and a central hub of the sizing element, and wherein rotation of the actuator ring causes axial movement thereof and of the hollow shaft until the clutch mechanism slips;

inserting the valve sizer into the patient so that the sizing element is positioned within the orifice; and

manipulating the actuator until the clutch mechanism begins to slip indicating that the sizer has engaged the orifice to a predetermined level.

11. The method of claim 10, wherein the orifice is a cardiac valve annulus, and the proximal handle includes a plurality of orifice sizes indicators and a display that stops on one of the indicated sizes when the clutch slips.

12. The method of claim 10, wherein the clutch mechanism further comprises a clutch ring mounted at the proximal end of the shaft and coupled for rotation to the actuator ring via a clutch mechanism and a plurality of bearings and springs held within the clutch ring, the plurality of bearings being biased by the springs into detents formed on an inner surface of the actuator ring.

13. The method of claim 10, wherein the sizing element is radially expandable between a retracted first position and an expanded second position, and wherein the sizing element includes a plurality of sizing petals radially expandable between the first and second positions.

14. A method of sizing a patient'"'"'s anatomical orifice, comprising:

providing a valve sizer having;

a proximal handle having an actuator;

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;

a clutch mechanism in the proximal handle configured to transmit movement from the actuator to the portion of the shaft that controls the size of the sizing element, wherein the sizing element and clutch mechanism are coupled together such that outward radial expansion of the sizing element into contact with a surrounding orifice transmits via the shaft a reaction force back to the clutch mechanism which slips at a predetermined reaction force; and

a sensor which senses a reaction force on the sizing element caused by outward radial expansion of the sizing element into contact with a surrounding orifice, wherein the shaft comprises a rod extending through a hollow shaft, the rod being fixed with respect to both the handle and a central hub of the sizing element, wherein axial movement of the hollow shaft with respect to the rod expands the sizing element, and wherein manipulation of the actuator causes axial movement of the hollow shaft and the sensor is a linear force sensor coupled to measure tension or compression in either the rod or the hollow shaft;

inserting the valve sizer into the patient so that the sizing element is positioned within the orifice; and

manipulating the actuator to expand the sizing element until the sensor senses a desired reaction force less than the predetermined reaction force and halting expansion of the sizing element when the desired reaction force is sensed.

15. The method of claim 14, wherein the orifice is a cardiac valve annulus, and the proximal handle includes a plurality of orifice sizes indicators and a display that stops on one of the indicated sizes when the desired reaction force is sensed.

16. The method of claim 14, wherein the actuator comprises an actuator ring, the valve sizer further having a clutch ring mounted at the proximal end of the shaft and coupled for rotation to the actuator via the clutch mechanism, and wherein the clutch mechanism comprises a plurality of bearings biased by springs into detents, and 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.

17. The method of claim 14, 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, and wherein the method includes passing the sizing element and shaft through a catheter.