DEVICE, SYSTEM AND METHOD FOR SIZING OF TISSUE OPENINGS

• US 20110245859A1
• Filed: 12/02/2009
• Published: 10/06/2011
• Est. Priority Date: 12/15/2008
• Status: Active Grant

• Current Assignee: Assist Medical LLC
• Original Assignee: Assist Medical LLC
• Inventors: Klaiman, Moshe, Carmeli, Ran, Yonat, Itai, Teichman, Eyal
• Granted Patent: US 9,005,139 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A device for determining a physical parameter of a tissue opening is provided. The device includes an expandable member which is designed for positioning within a tissue opening such as a valve annulus. The expandable member is capable of expanding while applying an inward radial force indicative of a diameter thereof. When the expandable member is positioned within the tissue opening and expanded, an increase in the inward radial force induced by contact between the expandable member and tissue surrounding the opening can be utilized to derive information relating to the physical parameter of the tissue opening.

Claims

1. A device for determining a physical parameter of a tissue opening comprising an expandable member designed for positioning within the tissue opening, said expandable member being capable of expanding while applying an inward radial force indicative of a diameter thereof, such that when said expandable member is positioned within the tissue opening and expanded, an increase in said inward radial force can be indicative of contact between said expandable member and tissue surrounding the tissue opening.

2. The device of claim 1, wherein said increase in said inward radial force can be utilized to derive information relating to the physical parameter of the tissue opening.

3. The device of claim 1, wherein said expandable member includes an inflatable balloon at least partially covered by a structure.

4. The device of claim 3, wherein said structure is a wire mesh, a wire spiral or wire struts.

5. The device of claim 2, wherein said structure is a tube.

6. The device of claim 3, wherein said inflatable balloon is a non-compliant balloon.

7. The device of claim 1, wherein the tissue opening is a valve annulus.

8. The device of claim 7, wherein said expandable member is designed for positioning within said valve annulus.

9. The device of claim 1, wherein said expandable member has an elastic diameter range of 4-35 mm.

10. The device of claim 1, wherein said physical parameter is a diameter of the tissue opening.

11. The device of claim 1, further comprising a plurality of imaging markers attached to said expandable member.

12. The device of claim 11, wherein said plurality of imaging markers are arranged in a pattern selected for indicating a cross sectional shape of said expandable member when in an expanded state.

13. The device of claim 1, wherein said expandable member is capable of elastic expansion without substantial structural deformation when expanded beyond a tissue contact diameter within the tissue opening.

14-24. -24. (canceled)

25. A system for determining a physical and/or functional parameter of a tissue opening comprising:

(a) a device including a semi-compliant balloon; and

(b) a controller for introducing fluid into said semi-compliant balloon and for measuring a volume and/or pressure of said fluid introduced into said semi-compliant balloon.

26. The system of claim 25, wherein said semi-compliant balloon is constructed from a non-compliant balloon at least partially covered by a compliant cage structure or from a balloon having a compliant mid section flanked by non-compliant end portions.

27. The system of claim 25, further comprising a user interface for providing a user with pressure and volume of said semi-compliant balloon and optionally dP/dV data.

28. A method of sizing a tissue opening comprising

(a) inflating a semi-compliant inflatable structure within said tissue opening;

(b) measuring volume and pressure of said inflatable structure during said inflation; and

(c) utilizing said volume and pressure measurements to determine a point of contact between said inflatable structure and tissue of the tissue opening to thereby size the tissue opening.

29. The method of claim 28, wherein the tissue opening is a valve annulus.

30. The method of claim 28, wherein said semi-compliant inflatable structure is a non-compliant balloon at least partially covered by a compliant cage structure

31. The method of claim 28, wherein said semi-compliant inflatable structure is a balloon having a compliant mid section flanked by non-compliant end portions.