Steerable delivery system for replacement mitral valve

• US 10,646,340 B2
• Filed: 08/17/2017
• Issued: 05/12/2020
• Est. Priority Date: 08/19/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Manash, Boaz, Cohen, Oren, Nir, Noam, Tamir, Ilan, Atias, Eitan, Witzman, Ofir, Ruchelsman, Michal Aliza
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US15/680,030
• Publication Number:
  US 20180049873A1
• Time in Patent Office: 999 Days
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00323 Cables or rods
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 : Guide wires

Abstract

Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Claims

1. A steerable medical device component, comprising:

a first elongate shaft having a proximal end and a distal end, the first elongate shaft comprising a bending section at the distal end;

a second elongate shaft having a proximal end and a distal end slideable over the first elongate shaft;

a nose cone coupled to the distal end of the first elongate shaft;

one or more pull wires connecting a proximal end of the nose cone and the distal end of the second elongate shaft; and

a replacement heart valve releasably attached to the steerable medical device component;

wherein when the second elongate shaft is translated proximally, the one or more pull wires pulls the nose cone causing the bending section to bend; and

wherein when the second elongate shaft is pushed distally to at least partially overlap with the bending section of the first elongate shaft, the bending section is configured to resist bending.

2. The steerable medical device component of claim 1, wherein the first and second elongate shafts are coaxial.

3. The steerable medical device component of claim 1, wherein the second elongate shaft comprises a pointed tip at the distal end.

4. The steerable medical device component of claim 1, wherein the bending section comprises a plurality of perforations.

5. The steerable medical device component of claim 4, wherein the perforations are diamond-shaped perforations.

6. The steerable medical device component of claim 1, wherein the bending section comprises a cut-out slot.

7. The steerable medical device component of claim 1, wherein the one or more pull wires comprise a plurality of pull wires.

8. The steerable medical device component of claim 7, wherein the first elongate shaft is configured to be bent in at least two planes.

9. The steerable medical device component of claim 1, further comprising a mid shaft having a distal end with an expanded diameter configured to at least partially cover the replacement heart valve.

10. The steerable medical device component of claim 9, further comprising an outer sheath configured translate proximally and distally over the second elongate shaft, and at least partially cover the replacement heart valve.

11. The steerable medical device component of claim 1, wherein the first elongate shaft comprises a metal hypotube.

12. The steerable medical device component of claim 1, wherein the first elongate shaft is encapsulated with a layer of PTFE.

13. The steerable medical device component of claim 1, wherein the second elongate shaft is a metal tube.

14. The steerable medical device component of claim 1, wherein the second elongate shaft is encapsulated with a layer of PTFE.

15. The steerable medical device component of claim 1, wherein the nose cone has a larger diameter than the first elongate shaft and the second elongate shaft.

16. The steerable medical device component of claim 1, wherein the one or more pull wires comprise one or more sutures.

17. The steerable medical device component of claim 1, wherein the replacement heart valve comprises a replacement mitral heart valve.

18. A steerable medical device component for implantation of a replacement heart valve, the steerable medical device component comprising:

a first elongate shaft having a proximal end and a distal end, the first elongate shaft comprising a bending section at the distal end, the bending section having a plurality of diamond-shaped perforations;

a second elongate shaft having a proximal end and a distal end slideable over the first elongate shaft;

a nose cone coupled to the distal end of the first elongate shaft, the nose cone having a diameter greater than a diameter of the first elongate shaft and the second elongate shaft; and

a plurality of pull sutures connecting a proximal end of the nose cone and the distal end of the second elongate shaft, the plurality of pull sutures being separate from and connected to the nose cone and the second elongate shaft;

wherein when the second elongate shaft is translated proximally, the plurality of pull sutures pulls the nose cone causing the bending section to bend.

19. A steerable medical device component for implantation of a replacement heart valve, the steerable medical device component comprising:

a first elongate shaft having a proximal end and a distal end, the first elongate shaft comprising a bending section at the distal end, the bending section having a plurality of perforations;

a second elongate shaft having a proximal end and a distal end slideable over the first elongate shaft;

an outer sheath slidably disposed over the first elongate shaft and the second elongate shaft;

a mid shaft having a distal end with an expanded diameter;

a nose cone coupled to the distal end of the first elongate shaft, the nose cone having a diameter greater than a diameter of the first elongate shaft and the second elongate shaft;

at least one pull suture connecting a proximal end of the nose cone and the distal end of the second elongate shaft, the at least one pull suture being separate from and connected to the nose cone and the second elongate shaft;

wherein when the second elongate shaft is translated proximally, the at least one pull suture pulls the nose cone causing the bending section to bend;

wherein proximal translation of the outer sheath is configured to release a distal end of a replacement heart valve; and

wherein proximal translation of the mid shaft is configured to release a proximal end of the replacement heart valve.