Balloon sizing of valve annulus for percutaneous valves

• US 8,406,867 B2
• Filed: 02/16/2010
• Issued: 03/26/2013
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: DTherapeutics LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/706,677
• Publication Number:
  US 20100168836A1
• Time in Patent Office: 1,134 Days
• Field of Search: 600/547, 600/481, 600/454, 600/505, 600/506, 600/526, 600/587, 600/486, 600/561, 600/485, 600/462, 600/466, 600/494, 600/301, 606/41, 606/192, 606/194, 606/198, 424/439, 623/1.11, 623/1.15, 623/23.7, 604/27
• US Class Current: 600/547
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

Balloon sizing of valve annulus for percutaneous valves. In at least one embodiment of a device to size a valve annulus of the present disclosure, the device comprises an elongated body extending from a proximal end to a distal end and having a lumen therethrough, a balloon positioned along the elongated body at or near the distal end, a detector and a pressure transducer positioned along the elongated body within the balloon, and a suction/infusion port defined within the elongated body within the balloon.

Claims

1. A method to size a valve annulus, the method comprising the steps of:

introducing at least part of a sizing device into a luminal organ at a valve annulus, the sizing device having a detector and a pressure transducer within a balloon positioned thereon;

inflating the balloon until a threshold pressure is detected by the pressure transducer within the balloon;

obtaining a first valve annulus measurement using the detector; and

withdrawing the sizing device from the luminal organ.

2. The method of claim 1, further comprising the steps of

positioning a stent valve upon the balloon;

reintroducing at least part of the sizing device into the luminal organ at the valve annulus; and

reinflating the balloon to the first valve atmulus measurement to place the stent valve within the valve annulus.

3. The method of claim 2, further comprising the step of:

rewithdrawing the sizing device from the luminal organ.

4. The method of claim 1, wherein the sizing device further comprises a catheter having a lumen therethrough and defining a suction/infusion port within the catheter within the balloon.

5. The method of claim 4, wherein the step of inflating the balloon comprises introducing a fluid into the lumen of the catheter, through the suction/infusion port, and into the balloon.

6. The method of claim 5, wherein the step of withdrawing the sizing device comprises removing fluid from the balloon, through the suction/infusion port, and into the lumen of the catheter, to deflate the balloon.

7. The method of claim 1, wherein the detector comprises two detection electrodes positioned in between two excitation electrodes, the excitation electrodes capable of producing an electric field to facilitate a conductance measurement of a fluid within the balloon.

8. The method of claim 7, wherein the step obtaining a first valve annulus measurement comprises obtaining a balloon cross sectional area using the detector.

9. The method of claim 1, wherein the step of obtaining a first valve annulus measurement comprises measuring a balloon cross-sectional area using the detector when the threshold pressure is present within the balloon.

10. The method of claim 9, wherein the balloon cross-sectional area is determined from a conductance measurement of a fluid present within the balloon obtained by the detector, a known conductivity of the fluid, and a known distance between two detection electrodes of the detector.

11. The method of claim 1, wherein the step of inflating the balloon comprises injecting a solution having a known conductivity into the balloon.

12. The method of claim 11, wherein the step of obtaining a first valve annulus measurement comprises measuring a cross-sectional area based in part of the conductivity of the fluid and a conductance value obtained using the detector.

13. A method to size a valve annulus, comprising the steps of:

introducing at least part of a sizing device into a luminal organ at a valve annulus, the sizing device having a detector within a balloon positioned thereon;

inflating the balloon within the valve annulus until a point of apposition is achieved; and

obtaining a first valve annulus measurement using the detector while the balloon is inflated to the point of apposition.

14. The method of claim 13, wherein the step of introducing at least part of the sizing device comprises introducing at least part of the sizing device so that the balloon is positioned at a valve flap of the valve annulus.

15. The method of claim 13, wherein the detector comprises two detection electrodes positioned in between two excitation electrodes, the excitation electrodes capable of producing an electric field to facilitate a conductance measurement of a fluid within the balloon.

16. The method of claim 13, wherein the step of obtaining a first valve annulus measurement comprises obtaining a balloon cross-sectional area measurement using the detector while a fluid having a known conductivity is present within the balloon.

17. The method of claim 13, further comprising the steps of:

withdrawing the sizing device from the luminal organ;

positioning a stent valve upon the balloon;

reintroducing at least part of the sizing device into the luminal organ at the valve annulus; and

reinflating the balloon to the point of apposition to place the stent valve within the valve annulus.

18. A method to size a valve annulus, comprising the steps of:

introducing at least part of a sizing device into a luminal organ at a valve annulus, the sizing device having a detector within a balloon positioned thereon;

inflating the balloon within the valve annulus until a threshold pressure is detected; and

obtaining a first valve annulus measurement using the detector while the balloon is inflated to the threshold pressure.

19. The method of claim 18, wherein the step of introducing at least part of the sizing device comprises introducing at least part of the sizing device so that the balloon is positioned at a valve flap of the valve annulus.

20. The method of claim 18, wherein the step of introducing at least part of the sizing device comprises introducing at least part of the sizing device having the balloon coupled thereto proximal to the detector but not coupled thereto distal to the detector.

21. The method of claim 18, wherein the step of introducing at least part of the sizing device comprises introducing at least part of the sizing device having the balloon coupled thereto proximal to the detector and coupled thereto distal to the detector.

22. The method of claim 18, wherein the step of obtaining a first valve annulus measurement comprises obtaining a balloon cross-sectional area measurement using the detector while a fluid having a known conductivity is present within the balloon.

23. The method of claim 18, further comprising the steps of:

withdrawing the sizing device from the luminal organ;

positioning a stent valve upon the balloon;

reintroducing at least part of the sizing device into the luminal organ at the valve annulus; and

reinflating the balloon to the first valve annulus measurement to place the stent valve within the valve annulus.