Devices, systems and methods for accurate positioning of a prosthetic valve

• US 9,381,082 B2
• Filed: 03/28/2012
• Issued: 07/05/2016
• Est. Priority Date: 04/22/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Duhay, Francis G., Zollinger, David L.
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US13/432,901
• Publication Number:
  US 20120271411A1
• Time in Patent Office: 1,560 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/198, 606/200, 623/2.1, 623/2.11
• US Class Current: 1/1
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The invention is a system and method for accurately positioning a prosthetic valve such as a prosthetic heart valve at a desired position for deployment. The invention includes extendable positioning elements which provide tactile feedback to a user to confirm proper positioning of the catheter with respect to the native valve annulus. During delivery, the extendable positioning elements lie against the catheter, over the prosthetic valve and expandable balloon, providing a low profile for advancing the catheter to the desired treatment location via small passages such as body lumens. Prior to valve deployment, the positioning elements are extended and brought into contact with tissue of the native annulus to confirm the proper positioning of the delivery system and prosthetic valve.

Claims

1. A catheter for delivering a prosthetic valve to a position within a patient, comprising:

a catheter proximal portion ending in a catheter proximal end;

a catheter distal portion ending in a catheter distal end, the catheter distal portion having an implant holding section configured to receive a prosthetic valve thereon;

a prosthetic valve positioned at the implant holding section, the prosthetic heart valve comprising a valve portion and a support portion, wherein the support portion is configured to support the valve portion and secure the valve portion in or adjacent a native valve annulus, wherein the support portion is the only structure configured to secure the valve portion in or adjacent the native valve annulus;

a catheter length from the catheter proximal end to the catheter distal end, wherein the catheter length is sufficient to reach from a position outside of a patient'"'"'s body to a position at a native valve annulus within the patient'"'"'s body; and

at least one extendable positioner configured to be selectively and radially extended from a first position to a second position, wherein in the first position the extendable positioner is positioned generally parallel to and against the catheter distal portion with the extendable positioner extending at least partially over the implant holding section, wherein in the second position at least a portion of the extendable positioner extends radially away from the catheter distal portion, wherein in the second position a portion of the extendable positioner extends longitudinally over but radially displaced away from and outside of the valve portion and the support portion of the prosthetic heart valve;

wherein the prosthetic heart valve is configured to be radially expanded and released from the catheter, and the extendable positioner is configured so that after the prosthetic heart valve is released from the catheter and deployed in the native valve annulus, the entirety of the extendable positioner remains secured to the catheter and is configured to be withdrawn in its entirety from the body with the catheter.

2. The catheter of claim 1, wherein the extendable positioner comprises a positioner fixed end secured to the catheter distal portion and a positioner free end, wherein in the first position the positioner fixed end is secured to and adjacent the catheter distal portion while the positioner free end is radially adjacent the catheter distal portion, wherein in the second position the positioner fixed end is secured to and adjacent the catheter distal portion while the positioner free end is extended radially away from the catheter distal portion.

3. The catheter of claim 2, wherein the catheter distal portion comprises a radial center, and wherein in the first position the positioner free end is positioned radially away from the radial center by a radial distance of about 2 to 5 mm.

4. The catheter of claim 2, wherein the catheter distal portion comprises a radial center, and wherein in the second position the positioner free end is positioned radially away from the radial center by a distance of about 7 to 18 mm.

5. The catheter of claim 2, wherein in the second position the positioner free end is positioned longitudinally aligned with a middle third portion of the implant holding section.

6. The catheter of claim 5, wherein the catheter distal portion comprises a sheath positioned over the implant holding section, wherein the sheath is configured to be slidingly retracted from the implant holding section, and wherein the catheter proximal portion comprises a valve deployment control configured to selectively and slidingly retract the sheath from the implant holding section, wherein the catheter proximal portion further comprises one or more positioner controls for selectively extending and retracting the extendable positioners.

7. The catheter of claim 5, wherein the implant holding section comprises an expandable balloon configured to be expanded from a first delivery diameter to a second deployment diameter, and wherein the catheter proximal portion comprises a valve deployment control configured to control expansion of the expandable balloon from the first delivery diameter to the second deployment diameter, wherein the catheter proximal portion further comprises one or more positioner controls for selectively extending and retracting the extendable positioner.

8. A system for replacing a deficient heart valve, comprising:

a prosthetic heart valve comprising a radially expandable support stent and one or more valve leaflets, wherein the prosthetic heart valve is configured to be radially expanded from a delivery diameter to a deployed diameter; and

a catheter comprising a catheter proximal portion ending in a catheter proximal end, the catheter further comprising a catheter distal portion ending in a catheter distal end, the catheter having an overall length extending from catheter proximal end to the catheter distal end, wherein the prosthetic heart valve is positioned on the catheter distal portion, the catheter further comprising a plurality of retractable members positioned on the catheter distal portion, each retractable member comprising a member fixed end secured to the catheter distal portion at a position adjacent the prosthetic heart valve, each retractable member further comprising a retractable member free end positioned at a distance longitudinally displaced with respect to the catheter distal portion such that the retractable member extends at least partially over the prosthetic heart valve, wherein each retractable member has a first position wherein the retractable member free end is positioned radially adjacent the catheter distal portion and the retractable member is generally lengthwise and parallel to the catheter distal portion, and wherein each retractable member has a second position wherein the retractable member free end is radially displaced away from the catheter distal portion such that the retractable member is generally non-parallel with the catheter distal portion, and wherein in the second position the retractable member free end is not secured to or contacting any structure other than the retractable member itself, wherein in the second position a portion of the retractable member extends longitudinally over but radially displaced away from and outwardly of the prosthetic heart valve;

wherein the prosthetic heart valve is configured to be radially expanded and released from the catheter, and the retractable member is adapted such that after the prosthetic heart valve is released from the catheter the entirety of the retractable member including the retractable member free end and the portion which extends longitudinally over but radially displaced away from the prosthetic heart valve in the second position, remains secured to the catheter and is adapted to be withdrawn with the catheter from the body and away from the released prosthetic heart valve without disrupting the deployed prosthetic heart valve.

9. The system of claim 8, wherein the radially expandable support stent of the prosthetic heart valve is a self-expanding structure comprising a memory material, wherein the radially expandable support stent is configured to be biased to expand from an unexpanded delivery diameter to an expanded deployed diameter, wherein the catheter further comprises a sheath over at least part of the catheter distal portion, wherein the prosthetic heart valve is positioned on the catheter distal portion at a position at least partially underneath the sheath, and the retractable member in the first position extends at least partially over the sheath.

10. The system of claim 8, wherein the radially expandable support stent of the prosthetic heart valve comprises a generally rigid structure, wherein the radially expandable support stent is configured to be plastically and radially expanded from an unexpanded delivery diameter to an expanded deployed diameter via application of a radial expansion force, wherein the catheter further comprises an expandable balloon positioned on the catheter distal portion, wherein the prosthetic heart valve is positioned on the catheter distal portion at a position at least partially over the expandable balloon, and the retractable member in the first position extends at least partially over the expandable balloon.

11. The system of claim 8, wherein the retractable member fixed end is secured to the catheter at a position proximal of the prosthetic heart valve.

12. The system of claim 8, wherein the retractable member fixed end is secured to the catheter at a position distal of the prosthetic heart valve.

13. The system of claim 8, wherein the retractable member is biased toward the second position.

14. The system of claim 8, wherein the retractable member free end comprises a radiopaque marker having a radiopaque density greater than an average radiopaque density of the rest of the retractable member.

15. A device for delivering a prosthetic valve to a position within a patient, comprising:

a device proximal portion ending in a device proximal end, the device proximal portion comprising a device handle;

a device distal portion ending in a device distal end, the device distal portion having an implant holding section configured to receive a medical implant thereon;

a prosthetic valve releasably positioned on the implant holding section, the prosthetic valve comprising a valve portion and a support portion;

a device usable length from a distal end of the device handle to the device distal end, wherein the device usable length is sufficient to reach from a position outside of a patient'"'"'s body to a position within a native valve annulus within the patient'"'"'s body; and

at least one extendable positioner configured to be selectively and radially extended from a first position to a second position, wherein in the first position the extendable positioner is positioned generally parallel to and against the device distal portion and longitudinally over at least a portion of the prosthetic valve and implant holding section, wherein in the second position at least a portion of the extendable positioner extends radially away from the device distal portion and radially away from and outside of the prosthetic valve and outside of all other structures at or secured to the distal portion of the device while extending longitudinally over at least a portion of the prosthetic valve, wherein the entirety of the retractable member is configured to remain secured to the device distal portion and to be withdrawn from the body and away from the prosthetic heart valve with the device distal portion after release and deployment of the prosthetic valve within the native valve annulus within the patient'"'"'s body.

16. The device of claim 15, wherein the extendable positioner extends at least partially over the implant holding section.

17. The device of claim 16, wherein the extendable positioner comprises a positioner fixed end secured to the device distal portion, and a positioner free end configured to be selectively and radially extended away from the device distal portion.

18. The device of claim 17, wherein the positioner free end is positioned along the length of the device at a position distal of the positioner fixed end with respect to the length of the device.

19. The device of claim 17, wherein the positioner free end is positioned along the length of the device at a position proximal of the positioner fixed end with respect to the length of the device.

20. The device of claim 15, wherein at least one extendable positioner is configured to be selectively and longitudinally displaced from a targeting position adjacent the implant holding section to a deployment position longitudinally removed from the implant holding section.

21. The device of claim 15, wherein the extendable positioner comprises a positioner fixed end secured to the device distal portion and a positioner free end, wherein in the first position the positioner fixed end is secured to and adjacent the device distal portion while the positioner free end is radially adjacent the device distal portion, wherein in the second position the positioner fixed end is secured to and adjacent the device distal portion while the positioner free end is extended radially away from the device distal portion.

22. The device of claim 21, wherein in the second position the positioner free end is positioned longitudinally aligned with a middle third portion of the implant holding section.

23. The device of claim 22, wherein the device distal portion comprises a sheath positioned over the implant holding section, wherein the sheath is configured to be slidingly retracted from the implant holding section, and wherein the device proximal portion comprises a valve deployment control configured to selectively and slidingly retract the sheath from the implant holding section, wherein the device proximal portion further comprises one or more positioner controls for selectively extending and retracting the extendable positioner.

24. The device of claim 22, wherein the implant holding section comprises an expandable balloon configured to be expanded from a first delivery diameter to a second deployment diameter, and wherein the device proximal portion comprises a valve deployment control configured to control expansion of the expandable balloon from the first delivery diameter to the second deployment diameter, wherein the device proximal portion further comprises one or more positioner controls for selectively extending and retracting the extendable positioner.

25. The device of claim 15, wherein the device distal portion comprises a radial center, and wherein in the first position the positioner free end is positioned radially away from the radial center by a radial distance of about 2 to 5 mm.

26. The device of claim 15, wherein the device distal portion comprises a radial center, and wherein in the second position the positioner free end is positioned radially away from the radial center by a distance of about 7 to 18 mm.