LUMINAL ORGAN SIZING DEVICES AND METHODS

• US 20160256076A1
• Filed: 05/17/2016
• Published: 09/08/2016
• Est. Priority Date: 02/21/2003
• Status: Abandoned Application

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Application Number:
  US15/156,364
• Publication Number:
  US 20160256076A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• 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 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6869 Heart
• 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

Luminal organ sizing devices and methods. In at least one embodiment of a method of the present disclosure, the method comprises the steps of introducing at least part of a first device into a luminal organ at an aperture or opening of the luminal organ, the first device having a balloon positioned thereon; inflating the balloon at the aperture or opening of the luminal organ until a point of apposition is achieved; and obtaining a first aperture or opening measurement based upon the point of apposition.

Claims

1. A method, comprising the steps of:

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

inflating the balloon at the aperture or opening of the luminal organ until a point of apposition is achieved; and

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

2. 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.

3. 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 aperture or opening measurement is performed by obtaining a size measurement within the balloon using the electrode.

4. The method of claim 1, wherein conductance data is obtained at various stages of balloon inflation during the inflating step.

5. The method of claim 1, further comprising the step of:

operating an ablation contact positioned upon or within a surface of the balloon while the balloon is in contact with the luminal organ to ablate the luminal organ.

6. The method of claim 5, wherein the luminal organ comprises a renal artery, and wherein the method is performed to treat hypertension.

7. The method of claim 4, further comprising the step of:

determining various size measurements of the balloon corresponding to the conductance data obtained at the various stages of balloon inflation.

8. The method of claim 7, further comprising the step of:

determining compliance of the luminal organ at the opening or aperture based upon the various size measurements.

9. The method of claim 8, wherein the opening or aperture is a septum of a heart, and wherein the determining step is performed to determine compliance of the septum of the heart.

10. The method of claim 9, further comprising the step of:

treating an intraseptal ventricular defect based upon the determined compliance of the luminal organ.

11. A method, comprising the steps of:

introducing at least part of a first device into a luminal organ so that a balloon of the first device is positioned at an aperture or opening of the luminal organ;

inflating the balloon at the aperture or opening and obtaining conductance data within the balloon at various stages of balloon inflation using a detector positioned within the balloon;

determining various size measurements of the balloon corresponding to the conductance data obtained at the various stages of balloon inflation; and

determining compliance of the luminal organ at the aperture or opening based upon the various size measurements.

12. The method of claim 11, wherein the step of inflating is performed to inflate the balloon so that the balloon contacts the luminal organ at the aperture or opening and to obtain conductance data at various stages of balloon prior to the balloon contacting the luminal organ at the aperture or opening and after the balloon contacts the luminal organ at the aperture or opening.

13. The method of claim 12, wherein compliance of the luminal organ is determined as being rigid or relatively rigid based upon at least some of the various size measurements corresponding to conductance data obtained after the balloon contacts the luminal organ at the aperture or opening being consistent with one another.

14. The method of claim 12, wherein compliance of the luminal organ is determined as being compliant or relatively compliant based upon an increase in the various size measurements corresponding to conductance data obtained after the balloon contacts the luminal organ at the aperture or opening being consistent with one another.

15. The method of claim 12, wherein compliance of the luminal organ is determined as being rigid or relatively right based upon a lack of change in the various size measurements corresponding to conductance data obtained after the balloon contacts the luminal organ at the aperture or opening.

16. The method of claim 11, further comprising the step of:

operating an ablation contact positioned upon or within a surface of the balloon while the balloon is in contact with the luminal organ to ablate the luminal organ.

17. The method of claim 16, wherein the luminal organ comprises a renal artery, and wherein the method is performed to treat hypertension.

18. A method, comprising the steps of:

introducing at least part of a first device into a luminal organ so that a balloon of the first device is positioned at an aperture or opening of the luminal organ;

first inflating the balloon at the aperture or opening and obtaining first conductance data within the balloon at various stages of balloon inflation until the balloon contacts the luminal organ at the aperture or opening;

second inflating the balloon at the aperture or opening and obtaining second conductance data within the balloon at various stages of balloon inflation after the balloon contacts the luminal organ at the aperture or opening;

determining various size measurements of the balloon corresponding to the second conductance data; and

determining compliance of the luminal organ at the aperture or opening based upon the various size measurements.

19. The method of claim 18, wherein compliance of the luminal organ is determined as being compliant or relatively compliant based upon an increase in the various size measurements corresponding to the second conductance data.

20. The method of claim 18, wherein compliance of the luminal organ is determined as being rigid or relatively right based upon a lack of change in the various size measurements corresponding to the second conductance data.