TAVI Inflation with Auto-adjustment for Material and Processing Variation

Patent metadata

Field	Value
Publication number	US-2025213361-A1
Application number	US-202418966929-A
Country	US
Kind code	A1
Filing date	Dec 3, 2024
Priority date	Dec 28, 2023
Publication date	Jul 3, 2025
Grant date	—

Abstract

In some embodiments, a method of delivering a medical device includes providing a prosthetic heart valve including a collapsible and expandable stent having struts and a valve assembly coupled to the stent, the valve assembly having a plurality of leaflets and a cuff, providing a delivery device including a catheter extending between a proximal end and a distal end, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximal the inflatable balloon, inflating the inflatable balloon in a first stage, measuring a first pressure with the at least one sensor, and calculating a fluid resistance factor during the first stage.

First claim

1 . A method of delivering a medical device, the method comprising:
providing a prosthetic heart valve including a collapsible and expandable stent having struts and a valve assembly coupled to the stent, the valve assembly having a plurality of leaflets and a cuff; providing a delivery device including a catheter extending between a proximal end and a distal end, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximal the inflatable balloon; inflating the inflatable balloon in a first stage; measuring a first pressure with the at least one sensor; and calculating a fluid resistance factor during the first stage.

2 . The method of claim 1 , wherein inflating the inflatable balloon in a first stage comprises inflating the inflatable balloon to approximately 15% of its full volume.

3 . The method of claim 2 , wherein measuring a first pressure with the at least one sensor comprises measuring a first pressure during the first stage.

4 . The method of claim 1 , further comprising inflating the inflatable balloon in a second stage.

5 . The method of claim 4 , wherein inflating the inflatable balloon in a second stage is performed after the first stage.

6 . The method of claim 4 , wherein inflating the inflatable balloon in a second stage comprises inflating the inflatable balloon at least until the inflatable balloon is in contact with a native valve annulus.

7 . The method of claim 6 , further comprising the step of calculating a balloon pressure during the second stage using the fluid resistance factor.

8 . The method of claim 1 , wherein inflating the inflatable balloon in a first stage comprises expanding the inflatable balloon in an unconstrained state prior to implantation.

9 . The method of claim 8 , further comprising the step of re-crimping the prosthetic heart valve after the first stage.

10 . A method of delivering a medical device, the method comprising:
providing a prosthetic heart valve including a collapsible and expandable stent having struts and a valve assembly coupled to the stent, the valve assembly having a plurality of leaflets and a cuff; providing a delivery device including a catheter extending between a proximal end and a distal end, an inflatable balloon disposed at the distal end of the catheter, and at least one sensor disposed proximal the inflatable balloon; inflating the inflatable balloon in a first stage; and analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage.

11 . The method of claim 10 , wherein analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of fluid viscosity on inflation of the inflatable balloon.

12 . The method of claim 10 , wherein analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of an inflation media on inflation of the inflatable balloon.

13 . The method of claim 12 , wherein the inflation media comprises a mixture of saline and contrast solution.

14 . The method of claim 10 , wherein analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of catheter length on inflation of the inflatable balloon.

15 . The method of claim 10 , wherein analyzing an effect of a first parameter on inflation of the inflatable balloon during the first stage comprises analyzing an effect of catheter diameter on inflation of the inflatable balloon.

16 . The method of claim 10 , wherein inflating the inflatable balloon in a first stage comprises inflating the inflatable balloon to approximately 15% of its full volume.

17 . The method of claim 10 , further comprising inflating the inflatable balloon in a second stage.

18 . The method of claim 17 , wherein inflating the inflatable balloon in a second stage is performed after the first stage.

19 . The method of claim 17 , wherein inflating the inflatable balloon in a second stage comprises inflating the inflatable balloon at least until the inflatable balloon is in contact with a native valve annulus.

20 . The method of claim 10 , wherein inflating the inflatable balloon in a first stage comprises expanding the inflatable balloon in air prior to implantation.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Schulzetenberg Robert
• Ness Peter J
• Morrissey Michael Shane
• Schuman Victoria

Classifications

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2472

  Devices for testing · CPC title

• A61F2240/008

  Means for testing implantable prostheses · CPC title

• A61F2/2433 Primary

  using balloon catheter · CPC title