Method of determining size of cardiac prosthesis

• US 7,357,814 B2
• Filed: 05/18/2005
• Issued: 04/15/2008
• Est. Priority Date: 03/25/2003
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/132,059
• Publication Number:
  US 20050215100A1
• Time in Patent Office: 1,063 Days
• Field of Search: 623 211- 241, 335/11
• 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 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.

2. The method of claim 1, 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.

3. The method of claim 1, 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.

4. The method of claim 1, further comprising adjusting the cross-sectional dimension of the contact member.

5. The method of claim 4, wherein the adjusting of the cross-sectional dimension of the contact member includes one of supplying and removing fluid from within the contact member.

6. The method of claim 4, 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.

7. The method of claim 1, wherein the contact member has a curved surface that is engaged by the at least one leaflet after the contact member has been positioned to the appropriate position.

8. The method of claim 7, wherein an elongated member extends from the contact member and an aperture extends through the elongated member, the aperture terminating in an opening near the contact member, the method further comprising supplying fluid into the aperture to perform the urging.

9. The method of claim 8, wherein the contact member has a first axis that is 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.

10. The method of claim 9, the aperture terminating near a surface of the contact member that is opposite the curved surface.

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

positioning a contact member to face at least one functioning leaflet of the patient'"'"'s heart valve; and

ascertaining sizing requirements for the cardiac prosthesis based on coaptation between the at least one functioning leaflet and the contact member; and

urging the at least one functioning leaflet toward the contact member, the sizing requirements for the cardiac prosthesis being ascertained based on an amount of cooptation achieved in response to the urging.

12. The method of claim 11, wherein an elongated member extends from the contact member and an aperture extends through the elongated member, the aperture terminating in an opening near the contact member, the method further comprising supplying fluid into the aperture to perform the urging.

13. The method of claim 11, wherein the contact member has a curved surface that is configured to be engaged by the at least one functioning leaflet after the positioning of the contact member and in response to the urging.

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

positioning a contact member to face at least one functioning leaflet of the patient'"'"'s heart valve;

ascertaining sizing requirements for the cardiac prosthesis based on coaptation between the at least one functioning leaflet and the contact member;

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

implanting the cardiac prosthesis at an annulus of the patient'"'"'s heart valve such that the at least one functioning leaflet is moveable into and out of engagement relative to the buttress to provide for substantially unidirectional flow of blood through the annulus heart valve.

15. The method of claim 14, wherein the cardiac prosthesis further comprises an outer sheath of a flexible, biocompatible material covering at least the buttress.

16. A method comprising:

providing a sizing apparatus, the sizing apparatus 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;

positioning the curved surface of the contact member so as to face the at least one functioning leaflet of the heart valve;

urging the at least one functioning leaflet toward its closed position and toward the curved surface of the contact member such that engagement between the at least one functioning leaflet and the contact member can be observed; and

using the sizing apparatus to ascertain sizing requirements for a cardiac prosthesis based on observing the engagement between the at least one functioning leaflet and the contact member.

17. A method comprising:

providing a sizing apparatus, the sizing apparatus 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;

positioning the curved surface of the contact member so as to face the at least one functioning leaflet of the heart valve;

using the sizing apparatus to ascertain sizing requirements for a cardiac prosthesis based on observing engagement between the at least one functioning leaflet and the contact member;

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

implanting the cardiac prosthesis at an annulus of the patient'"'"'s heart valve such that the at least one functioning leaflet is moveable into and out of engagement relative to the buttress to provide for substantially unidirectional flow of blood through the annulus heart valve.