Catheter-Based Heart Valve Therapy System with Sizing Balloon

• US 20110208293A1
• Filed: 02/23/2010
• Published: 08/25/2011
• Est. Priority Date: 02/23/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tabor, Charles
• Application Number:
  US12/710,852
• Publication Number:
  US 20110208293A1
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61B 5/02156 Calibration means
• CPC Class Codes: A61B 5/023 the pressure transducers comprising a liquid column
• 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
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A catheter-based heart valve therapy system, includes a stented heart valve prosthesis including a stent frame having a valvular contact region that is configured to make contact with a heart valve and nearby anatomy of a patient. A sizing balloon includes a first region having a shape in an inflated state that matches a shape of the valvular contact region of the stent frame in an expanded state. At least one catheter-based delivery system is configured to deliver the sizing balloon to the heart valve of the patient for a size determination, and deliver the prosthesis to the heart valve for implantation.

Claims

1. A catheter-based heart valve therapy system, comprising:

a stented heart valve prosthesis including a stent frame having a valvular contact region that is configured to make contact with a heart valve and nearby anatomy of a patient;

a sizing balloon including a first region having a shape in an inflated state that matches a shape of the valvular contact region of the stent frame in an expanded state; and

at least one catheter-based delivery system configured to deliver the sizing balloon to the heart valve of the patient for a size determination, and deliver the prosthesis to the heart valve for implantation.

2. The heart valve therapy system of claim 1, wherein the sizing balloon is a prosthesis-specific sizing balloon that corresponds to a prosthesis type and a prosthesis size of the stented heart valve prosthesis.

3. The heart valve therapy system of claim 1, wherein the valvular contact region of the prosthesis and the first region of the sizing balloon each have a shape that is tapered such that a diameter of these regions increases going from a proximal end of these regions to a distal end of these regions.

4. The heart valve therapy system of claim 3, wherein the distal end of the prosthesis corresponds to an inflow end of the prosthesis.

5. The heart valve therapy system of claim 1, wherein the valvular contact region of the prosthesis and the first region of the sizing balloon each have a shape that includes a first portion with a first substantially constant diameter and a second portion with a second substantially constant diameter, wherein the first and second diameters are different.

6. The heart valve therapy system of claim 5, wherein the valvular contact region of the prosthesis and the first region of the sizing balloon each have a shape that further includes a tapered portion with a varying diameter that connects the first portion and the second portion.

7. The heart valve therapy system of claim 5, wherein the second portion corresponds to distal ends of the prosthesis and balloon, and wherein the second substantially constant diameter is larger than the first substantially constant diameter.

8. The heart valve therapy system of claim 1, wherein the sizing balloon is configured to generate a radial force on the heart valve that is substantially similar to an amount of radial force that is generated by the prosthesis.

9. The heart valve therapy system of claim 1, wherein the sizing balloon has a compliance that is substantially similar to a compliance of the stent frame.

10. The heart valve therapy system of claim 1, wherein the sizing balloon includes a visually detectable marker that is configured to facilitate accurate placement of the balloon within the heart valve.

11. The heart valve therapy system of claim 10, wherein the visually detectable marker is configured to be aligned with an annulus of the heart valve.

12. A method of performing a therapeutic procedure on a heart valve, comprising:

providing a plurality of differently-sized stented heart valve prostheses, each of the prostheses including a stent frame with a valvular contact region that is configured to make contact with a heart valve and nearby anatomy of a patient, the valvular contact regions of the plurality of prostheses having a common shape in an expanded state;

inflating a first sizing balloon within the heart valve of the patient to determine a size of the heart valve, wherein the inflating of the first sizing balloon causes a first portion of the first sizing balloon to assume a shape that matches the common shape;

selecting one of the stented heart valve prostheses based on the determined size of the heart valve;

delivering the selected stented heart valve prosthesis to the heart valve via a catheter-based delivery system; and

deploying the selected stented heart valve prosthesis from the delivery system at the heart valve.

13. The method of claim 12, and further comprising:

determining an initial estimate of the size of the heart valve using an imaging technique; and

selecting the first sizing balloon from a plurality of differently-sized sizing balloons based on the initial estimate.

14. The method of claim 12, wherein the size of the heart valve is determined based on imaging the inflating of the first sizing balloon.

15. The method of claim 14, wherein the size of the heart valve is determined based additionally on intraballoon pressure information.

16. The method of claim 12, and further comprising:

performing a balloon aortic valvuloplasty (BAV) procedure with the first sizing balloon prior to determining the size of the heart valve.

17. The method of claim 16, and further comprising:

applying a high radial force to the heart valve with the first sizing balloon during the BAV procedure; and

reducing the radial force to the heart valve to determine the size of the heart valve.

18. The method of claim 16, wherein the first sizing balloon comprises a balloon-in-balloon system including an inner balloon and an outer balloon having different radial forces.

19. The method of claim 12, wherein the first sizing balloon is a prosthesis-specific sizing balloon that corresponds to a particular prosthesis type and a particular prosthesis size.

20. A catheter-based heart valve therapy system, comprising:

a plurality of differently-sized stented heart valve prostheses, each of the prostheses including a stent frame with a valvular contact region that is configured to make contact with a heart valve and nearby anatomy of a patient, the valvular contact regions of the plurality of prostheses having a common shape in an expanded state;

a prosthesis-specific sizing balloon that corresponds to a prosthesis type of the plurality of prostheses and corresponds to a prosthesis size of a first subset of the plurality of prostheses, wherein the sizing balloon includes a first region having a shape in an inflated state that is the same as the common shape; and

at least one catheter-based delivery system configured to deliver the sizing balloon to the heart valve of the patient for a size determination, and deliver one of the prostheses from the first subset to the heart valve for implantation.

21. The heart valve therapy system of claim 20, wherein the common shape has a varying diameter.