Chordae tendineae management devices for use with a valve prosthesis delivery system and methods of use thereof

• US 10,493,248 B2
• Filed: 11/09/2016
• Issued: 12/03/2019
• Est. Priority Date: 11/09/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Devereux, Paul, Frisby, Paraic, White, Frank, Kitt, Tomas, Anderson, Marc, Carroll, Grainne, McGuinness, Ciaran, Jones, Tim
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/346,971
• Publication Number:
  US 20180126127A1
• Time in Patent Office: 1,119 Days
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Claims

1. A method of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae, the method comprising the steps of:

positioning a chordae management catheter within a ventricle of the heart, the chordae management catheter having a displacement balloon at a distal end thereof, wherein the displacement balloon is an annular component defining a central lumen therethrough;

inflating the displacement balloon within the ventricle to push chordae tendineae radially outward;

introducing a valve delivery system into the ventricle of the heart via a ventricular wall of the heart, the valve delivery system having the valve prosthesis at a distal portion thereof, wherein the valve prosthesis is in a delivery configuration;

advancing the valve delivery system through the central lumen of the inflated displacement balloon towards the annulus of the native valve of the heart; and

deploying the valve prosthesis into apposition with the annulus of the native valve.

2. The method of claim 1, wherein the step of positioning a chordae management catheter within the ventricle of the heart includes introducing the chordae management catheter into the apex of the heart.

3. The method of claim 1, wherein the step of positioning a chordae management catheter within the ventricle of the heart includes advancing the chordae management catheter through the aorta and into the left ventricle.

4. The method of claim 1, wherein the step of positioning a chordae management catheter within the ventricle of the heart includes advancing the chordae management catheter transseptally into the left atrium and into the left ventricle.

5. The method of claim 1, wherein the displacement balloon has a cylindrical or spherical inflated profile.

6. The method of claim 1, wherein a coating is applied to an inner sidewall of the displacement balloon such that the inner sidewall is stronger than an outer sidewall of the displacement balloon.

7. The method of claim 1, wherein the displacement balloon includes a first inflation lumen and a second inflation lumen and the step of inflating the displacement balloon includes delivery of a saline solution through the first inflation lumen and delivery of a contrast solution through the second inflation lumen.

8. The method of claim 7, wherein the second inflation lumen includes a pattern including three circumferentially spaced apart markers.

9. The method of claim 1, further comprising the steps of:

deflating the displacement balloon and at least partially removing the chordae management catheter prior to the step of deploying the valve prosthesis.

10. A method of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae, the method comprising the steps of:

positioning a chordae management catheter within a ventricle of the heart, the chordae management catheter having a displacement balloon at a distal end thereof, wherein the displacement balloon is an annular component defining a central lumen therethrough;

inflating the displacement balloon within the ventricle to push chordae tendineae radially outward;

positioning a second chordae management catheter within the ventricle of the heart, the chordae management catheter having a second displacement balloon at a distal end thereof, wherein the second displacement balloon is an annular component defining a second central lumen therethrough;

inflating the second displacement balloon within the ventricle to push chordae tendineae radially outward;

introducing a valve delivery system into the ventricle of the heart via a ventricular wall of the heart, the valve delivery system having the valve prosthesis at a distal portion thereof, wherein the valve prosthesis is in a delivery configuration;

advancing the valve delivery system through the central lumen of the inflated displacement balloon towards the annulus of the native valve of the heart, wherein the step of advancing the valve delivery system includes advancing the valve delivery system through the central lumen of the inflated displacement balloon as well as through the second central lumen of the inflated second displacement balloon; and

deploying the valve prosthesis into apposition with the annulus of the native valve.

11. The method of claim 10, wherein the step of positioning a chordae management catheter within the ventricle of the heart includes advancing the chordae management catheter through the aorta and into the left ventricle and the step of positioning a second chordae management catheter within the left ventricle of the heart includes advancing the chordae management catheter through the aorta and into the left ventricle.

12. The method of claim 10, wherein the step of positioning a chordae management catheter within the ventricle of the heart includes advancing the chordae management catheter through the aorta and into the left ventricle.

13. The method of claim 12, wherein the step of positioning a second chordae management catheter within the ventricle of the heart includes advancing the second chordae management catheter through the aorta and into the left ventricle.

14. The method of claim 10, wherein the displacement balloon has a donut-shaped configuration.

15. The method of claim 14, wherein the second displacement balloon has a donut-shaped configuration.

16. The method of claim 10, further comprising the steps of:

deflating the displacement balloon and at least partially removing the chordae management catheter prior to the step of deploying the valve prosthesis.

17. The method of claim 16, further comprising the steps of:

deflating the second displacement balloon and at least partially removing the chordae management catheter prior to the step of deploying the valve prosthesis.

18. The method of claim 10, wherein the step of positioning a second chordae management catheter within the ventricle of the heart includes positioning the second chordae management catheter such that the displacement balloon and the second displacement balloon are longitudinally and circumferentially aligned.

19. The method of claim 10, wherein the step of introducing a valve delivery system into the ventricle of the heart via a ventricular wall of the heart includes introducing the valve delivery system into the apex of the heart.