Droop tester apparatus and method

• US 9,180,009 B2
• Filed: 05/25/2012
• Issued: 11/10/2015
• Est. Priority Date: 05/25/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Majkrzak, Carolyn, Lee, Roger, Garde, Kshitija, Richardson, Eric, Wong, Benjamin
• Primary Examiner(s): Vaughn, Jr., William C
• Assistant Examiner(s): Uhl, Lindsay
• Application Number:
  US13/480,743
• Publication Number:
  US 20120300063A1
• Time in Patent Office: 1,264 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2002/7635 for measuring force, pressure or mechanical tension
• CPC Class Codes: G01B 11/02 for measuring length, width or thickness G01B11/08 takes precedence
• CPC Class Codes: G01B 11/028 by measuring lateral position of a boundary of the object G01B11/022, G01B11/024, G01B11/04 take precedence
• CPC Class Codes: G01B 11/2433 for measuring outlines by shadow casting
• CPC Class Codes: G01L 1/24 by measuring variations of optical properties of material when it is stressed, e.g. by photoelastic stress analysis using infrared, visible light, ultraviolet
• CPC Class Codes: H04N 7/18 Closed-circuit television [CCTV] systems, i.e. systems in which the video signal is not broadcast

Abstract

The invention relates to a system for testing heart valve leaflets. The system includes a leaflet support assembly with a support post for receiving and supporting a leaflet to be tested, the post being disposed in a target region of the support assembly. The system also has a transmitter assembly that includes a light source and is configured and arranged to direct light from the light source onto the target region. The system further includes a receiver assembly that has an image sensor configured and arranged to sense an image of the target region and generate image information indicative of the sensed image, such as leaflet droop.

Claims

1. A system for testing heart valve leaflets, each leaflet defining opposing tab ends, the system comprising:

a leaflet support assembly including a support post for receiving and supporting a leaflet to be tested, the post being disposed in a target region of the support assembly, wherein the support assembly further includes a base configured for placement on a flat surface, and a wall projecting from a floor of the base, and further wherein the post projects from the wall at a location spaced from the floor to define a vertical spacing between the post and the floor sufficient to permit a leaflet to be tested to freely hang from the post;

a transmitter assembly including a light source, wherein the transmitter assembly is configured and arranged to direct light from the light source onto the target region; and

a receiver assembly including a first image sensor configured and arranged to sense an image of the target region and generate image information indicative of the sensed image;

wherein the image information is indicative of leaflet droop.

2. The system of claim 1, wherein the support post is arranged to support a leaflet to be tested in a manner permitting the corresponding opposing tab ends to freely hang downwardly relative to the post due to gravity.

3. The system of claim 1, wherein the support assembly further includes a distance indicator located along the wall within the target region and immediately below the post.

4. The system of claim 1, wherein the transmitter assembly further includes a lens arrangement configured to direct light from the sensor onto the target region as a collimated beam of light.

5. The system of claim 1 wherein the light source includes a high-intensity GaN green LED.

6. The system of claim 1, wherein the transmitter assembly is arranged to direct light at a first side of the target region, and the first image sensor is arranged to sense an image of the target region relative to a second side of the target region opposite the first side.

7. The system of claim 1, wherein the first image sensor is configured to sense a shadow image of the target region.

8. The system of claim 1, wherein the first image sensor is a high-speed linear CCD.

9. The system of claim 1, wherein the receiver assembly further includes a second image sensor configured and arranged to sense an image of the target region and generate output information differing from the image information generated by the first image sensor.

10. The system of claim 9, wherein the second image sensor is a CMOS image sensor.

11. The system of claim 1, further comprising:

a controller electronically coupled to the first image sensor and programmed to determine a parameter relating to leaflet droop based upon the image information.

12. The system of claim 11, wherein the first image sensor is configured to generate the image information as being indicative of a shadow image of a leaflet disposed on the post in the target region, and further wherein the controller is programmed to determine a distance between opposing tab ends of the corresponding leaflet based upon the shadow image information.

13. The system of claim 12, wherein the controller is programmed to perform digital edge detection on the shadow image information.

14. The system of claim 1, further comprising:

a template defining a recess configured to generally arrange a leaflet to be tested about a center point;

wherein the template is configured to be coupled to the support assembly immediately adjacent the post.

15. A method of testing a leaflet for use with an implantable heart valve, the leaflet defining opposing tab ends, the method comprising:

loading the leaflet onto a support post of a leaflet support assembly and centering the leaflet over the post, including the leaflet being centrally supported by the post and the opposing tab ends freely hanging downwardly from the post due to gravity;

directing light onto the loaded leaflet;

collecting an image of the illuminated, loaded leaflet; and

determining a parameter related to leaflet droop based upon the collected image.

16. The method of claim 15, wherein the collected image is a shadow image.

17. The method of claim 16, wherein the step of determining a parameter includes determining a distance between opposing tab ends in the shadow image.