VALVE APERTURE SIZING DEVICES AND METHODS

• US 20130317392A1
• Filed: 03/26/2013
• Published: 11/28/2013
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: DTherapeutics LLC
• Inventors: Kassab, Ghassan S.
• Granted Patent: US 9,339,230 B2
• Time in Patent Office: Days
• US Class Current: 600/587
• 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

Valve aperture sizing devices and methods. In an exemplary method to size a valve aperture, the method comprises introducing at least part of a first device into a luminal organ at a valve aperture, the first device having a balloon positioned thereon, inflating the balloon within the valve aperture until a point of apposition is achieved, and obtaining a first valve aperture measurement based upon the point of apposition.

Claims

1. A method to size a valve aperture, comprising:

introducing at least part of a first device into a luminal organ at a valve aperture, the first device having a balloon positioned thereon;

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

obtaining a first valve aperture measurement based upon the point of apposition.

2. The method of claim 1, further comprising:

selecting a stent valve based upon the first valve aperture measurement.

3. The method of claim 2, further comprising:

positioning the stent valve upon the balloon;

re-introducing the at least part of the first device into the luminal organ; and

re-inflating the balloon to place the stent valve within the luminal organ.

4. The method of claim 3, wherein the step of re-introducing is performed to re-introduce the at least part of the first device into the luminal organ at or near the valve aperture, and wherein the step of re-inflating is performed to place the stent valve within the luminal organ at or near the valve aperture.

5. The method of claim 3, further comprising:

positioning the stent valve around at least part of a second device;

introducing the at least part of the second device into the luminal organ; and

positioning the stent valve within the luminal organ using the second device.

6. The method of claim 1, wherein the first device is configured as a catheter having a lumen therethrough and defining a suction/infusion port so that the lumen is in communication with the balloon, and wherein the step of inflating is performed by introducing a fluid through the lumen, through the suction/infusion port, and into the balloon.

7. The method of claim 1, wherein the first device further comprises at least one electrode positioned within the balloon, and wherein the step of obtaining the first valve aperture measurement is performed by obtaining a size measurement within the balloon using the electrode.

8. The method of claim 1, further comprising:

introducing a second device into the luminal organ, the second device selected from a plurality of devices based upon the first valve aperture measurement.

9. A method to size a valve aperture, comprising:

introducing at least part of a first device into a luminal organ at a valve aperture, the first device having a balloon positioned thereon;

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

obtaining a first valve aperture measurement based upon the threshold pressure.

10. The method of claim 9, further comprising:

selecting a stent valve based upon the first valve aperture measurement.

11. The method of claim 10, further comprising:

positioning the stent valve upon the balloon;

re-introducing the at least part of the first device into the luminal organ; and

re-inflating the balloon to place the stent valve within the luminal organ.

12. The method of claim 11, wherein the step of re-introducing is performed to re-introduce the at least part of the first device into the luminal organ at or near the valve aperture, and wherein the step of re-inflating is performed to place the stent valve within the luminal organ at or near the valve aperture.

13. The method of claim 10, further comprising:

positioning the stent valve around at least part of a second device;

introducing the at least part of the second device into the luminal organ; and

positioning the stent valve within the luminal organ using the second device.

14. The method of claim 9, wherein the first device further comprises a pressure transducer, and wherein the step of inflating is performed until the threshold pressure is detected by the pressure transducer.

15. The method of claim 9, wherein the first device is configured as a catheter having a lumen therethrough and defining a suction/infusion port so that the lumen is in communication with the balloon, and wherein the step of inflating is performed by introducing a fluid through the lumen, through the suction/infusion port, and into the balloon.

16. The method of claim 9, wherein the first device further comprises at least one electrode positioned within the balloon, and wherein the step of obtaining the first valve aperture measurement is performed by obtaining a size measurement within the balloon using the electrode.

17. The method of claim 9, further comprising:

introducing a second device into the luminal organ, the second device selected from a plurality of devices based upon the first valve aperture measurement.

18. A method to size a valve aperture, comprising:

introducing at least part of a first device into a luminal organ of a patient at a valve aperture, the first device having a balloon positioned thereon and an electrode positioned within the balloon;

inflating the balloon within the valve aperture until one or both of a threshold pressure and/or a point of apposition is detected; and

obtaining a first valve aperture measurement using the electrode based upon the one or both of the threshold pressure and/or the point of apposition.

19. The method of claim 18, further comprising:

selecting a stent valve based upon the first valve aperture measurement; and

positioning the stent valve within the luminal organ using the first device or a second device.

20. The method of claim 18, further comprising:

deflating the balloon;

removing the at least part of the first device from the luminal organ; and

performing a diagnostic or therapeutic procedure on the patient based upon the first valve aperture measurement.