Sizing apparatus for cardiac prostheses and method of using same

• US 20040193259A1
• Filed: 03/25/2003
• Published: 09/30/2004
• Est. Priority Date: 03/25/2003
• Status: Abandoned Application

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Application Number:
  US10/396,656
• Publication Number:
  US 20040193259A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A sizing apparatus and a method for ascertaining a size for a cardiac prosthesis are disclosed. Specifically, the sizing is implemented by positioning a contact member at a patient'"'"'s heart valve for engagement by one or more viable leaflets of the patient'"'"'s valve. The size is determined based on the engagement between the contact member and the leaflet (or leaflets) of the patient'"'"'s valve.

Claims

1. A sizing apparatus for a prosthetic device, comprising:

a contact member having a curved surface that is configured to be engaged by at least one functioning leaflet of a heart valve within a patient when the contact member is positioned at the heart valve; and

an elongated member extending from the contact member and terminating in a proximal end.

2. The sizing apparatus of claim 1, further comprising an aperture extending through the elongated member from the proximal end and terminating in an opening end near the contact member to facilitate flow of fluid therethrough.

3. The sizing apparatus of claim 2, the aperture terminating near a surface of the contact member opposite the curved surface.

4. The sizing apparatus of claim 2, further comprising a fluid source operative to supply fluid into the aperture.

5. The sizing apparatus of claim 4, the fluid source further comprising a syringe for providing fluid into the aperture.

6. The sizing apparatus of claim 4, further comprising a conduit interface that extends from the proximal end of the elongated member and terminates in a proximal end portion thereof, the proximal end portion of the conduit interface being adapted to connect to the fluid source.

7. The sizing apparatus of claim 6, the conduit interface further comprising a flexible material.

8. The sizing apparatus of claim 1, the contact member having a first axis substantially parallel with the elongated member and a second axis substantially perpendicular with the elongated member, the contact member being curved along at least one of the first and second axes.

9. The sizing apparatus of claim 1, the contact member being dimensioned and configured to approximate a radially inner surface of at least one leaflet at closure.

10. The sizing apparatus of claim 1, the contact member being configured to provide a cross-sectional dimension that is variable between a reduced cross-sectional dimension to facilitate positioning thereof at the heart valve and an expanded cross-sectional dimension to facilitate determining the size of a desired cardiac prosthesis based on engagement between the contact member and the at least one leaflet.

11. The sizing apparatus of claim 10, the contact member further comprising a fluid impermeable outer membrane having an inner chamber, the outer membrane defining the cross-sectional dimension of the contact member based on an amount of fluid within the inner chamber.

12. The sizing apparatus of claim 10, further comprising a control member operative to adjust the cross-sectional dimension of the contact member to a desired size.

13. The sizing apparatus of claim 10, further comprising a retaining mechanism operative to adjust the cross-sectional dimension of the contact member to a desired size, the contact member being self-expanding from the reduced cross-sectional dimension to the expanded cross-sectional dimension.

14. The sizing apparatus of claim 13, the retaining mechanism further comprising at least one elongated elements having distal ends connected to lateral edges of the contact member and proximal ends that extend from the contact member, the cross-sectional dimension of the contact member, varying as a function of the length of at least one of the connecting elements between the proximal end of the elongated member and the respective lateral edge of the contact member to which the at least one connecting element is connected.

15. The sizing apparatus of claim 10, the contact member comprising a material having shape memory properties so that the contact member is self-expanding from the reduced cross-sectional dimension to the expanded cross-sectional dimension.

16. An apparatus for determining an appropriate size for a prosthetic device, comprising:

means for contacting at least one leaflet of a patient'"'"'s heart valve, such that the amount of coaptation between the at least one leaflet and the means for contacting is indicative of sizing requirements for a cardiac prosthesis; and

means to facilitate positioning the means for contacting to an appropriate position relative to the at least one leaflet of the patient'"'"'s heart valve, the means for positioning extending from the means for contacting.

17. An apparatus as set forth in claim 16, including means for urging the at least one viable leaflet toward the means for contacting.

18. A sizing apparatus for a prosthetic device, comprising:

a contact member having a curved surface that is configured to be engaged by at least one functioning leaflet of a heart valve within a patient when the contact member is positioned at the heart valve;

an elongated member extending from the contact member and terminating in a proximal end; and

an aperture extending through the elongated member from the proximal end and terminating in an opening end proximal the contact member to facilitate flow of fluid therethrough.

19. A method to facilitate selecting a cardiac prosthesis for implantation at a patient'"'"'s heart valve, the method comprising:

positioning a contact member to an appropriate position relative to at least one leaflet of the patient'"'"'s heart valve;

urging the at least one leaflet of a patient'"'"'s heart valve toward the contact member, the contact member having a known cross-sectional dimension; and

determining sizing requirements for the cardiac prosthesis based on coaptation between the at least one leaflet and the contact member.

20. The method of claim 19, further comprising:

selecting a cardiac prosthesis based on the determined sizing requirements, the cardiac prosthesis comprising a generally arcuate base and a buttress extending from the base; and

implanting the cardiac prosthesis at the patient'"'"'s heart valve such that the at least one leaflet is moveable relative to the buttress to provide substantially unidirectional flow of blood through the heart valve.

21. The method of claim 19, wherein the contact member is a first contact member and the method further includes positioning a second contact member having a different cross-sectional dimension than that of the first contact member in place of the first contact member.

22. The method of claim 19, further comprising adjusting the cross-sectional dimension of the contact member.

23. The method of claim 22, wherein the adjusting of the cross-sectional dimension of the contact member includes one of supplying and removing fluid from within the contact member.

24. The method of claim 22, wherein the contact member is self-expanding from a reduced cross-sectional dimension to an expanded cross-sectional dimension, and the adjusting of the cross-sectional dimension of the contact member includes adjusting a length of at least one retaining mechanism that is operatively connected to the contact member.