STEERABLE DELIVERY SYSTEM FOR REPLACEMENT MITRAL VALVE AND METHODS OF USE

• US 20180049873A1
• Filed: 08/17/2017
• Published: 02/22/2018
• 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
• Granted Patent: US 10,646,340 B2
• Time in Patent Office: 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 bending section comprising a plurality of rings axially connected to one another to form a lumen through the plurality of rings, each of the plurality of rings having an inner surface and comprising;

at least one generally proximally extending pivot member;

at least one generally distally facing pivot member;

wherein the at least one generally proximally extending pivot member is configured to pivotably connect to the at least one generally distally facing pivot member of an adjacent ring;

an eyelet located on the inner surface;

at least one pull wire having a distal end and a proximal end and extending through the eyelet and the lumen of the plurality of rings, wherein the distal end of the at least one pull wire is connected to a distal section of the bending section;

a chain and sprocket system comprising a chain and a sprocket, wherein an end of the chain is connected to the proximal end of the at least one pull wire, and wherein a middle portion of the chain wraps at least partially around the sprocket; and

an articulation knob connected to the sprocket for articulation of the bending section by pulling the at least one pull wire.

2. The steerable medical device component of claim 1, further comprising at least two pull wires, each of the at least two pull wires located radially opposite one another through the lumen of the plurality of rings providing for two-dimensional bending of the bending section.

3. The steerable medical device component of claim 1, further comprising at least four pull wires, each of the pull wires located approximately 90°

from an adjacent pull wire and providing for three-dimensional bending of the bending section.

4. The steerable medical device component of claim 3, further comprising a second chain and sprocket system and a second articulation knob.

5. The steerable medical device component of claim 1, wherein each of the plurality of rings comprises two generally proximal extending pivot members and two generally distally facing pivot members.

6. 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; and

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

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.

7. The steerable medical device component of claim 6, wherein the first and second elongate shafts are coaxial.

8. The steerable medical device component of claim 6, wherein the second elongate shaft comprises a pointed tip at the distal end.

9. The steerable medical device component of claim 6, wherein the bending section comprises a plurality of perforations.

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

11. A delivery system for delivering an expandable implant to a body location, comprising:

an outer sheath assembly having a proximal end and a distal end, the outer sheath assembly configured to cover a distal end of the expandable implant in a compressed position so that at least one anchor on the expandable implant extends distally;

a nose cone attached to a distal end of a nose cone shaft, the nose cone comprising a pulley;

a handle located at a proximal end of the nose cone shaft and outer sheath assembly, the handle comprising an actuator;

at least one tether having a proximal end and a distal end, the proximal end configured to be operably connected to the actuator and the distal end configured to be operably connected to an anchor of the expandable implant, wherein a portion of the at least one tether between the distal and proximal end extends through the pulley in the nose cone;

wherein tension on the at least one tether is configured to prevent the anchor from flipping proximally when the outer sheath assembly is removed; and

wherein the actuator is configured to be actuated to release the tension in the at least one tether thereby allowing the anchor to controllably flip to a proximal direction.

12. The delivery system of claim 11, wherein the tether comprises a pull wire forming a double strand, the double strand having a loose-strand end formed by two ends of the pull wire and a continuous end.

13. The delivery system of claim 12, wherein the loose-strand end is configured to be coupled to the actuator and the continuous end is configured to be coupled to the anchor of the implant.

14. The delivery system of claim 12, wherein the pull wire loops through an eyelet of the anchor at the continuous end.

15. The delivery system of claim 14, wherein the loose-strand end is configured to be released from the actuator so that one of the two ends of the pull wire can be pulled to release the anchor from the tether.

16. The delivery system of claim 11, wherein the expandable implant comprises a plurality of anchors and at least as many tethers as anchors.

17. The delivery system of claim 11, wherein the nose cone comprises an expandable nose cone.

18. The delivery system of claim 11, further comprising a self-expanding wire balloon on a guide wire.

19. A method of delivering the expandable implant into a heart using the delivery system of claim 11, the method comprising:

translating the delivery system at least partially across a fossa ovalis of the heart; and

bending the delivery system away from the fossa ovalis to use the fossa ovalis as a hinge so that delivery system distal to the fossa ovalis is directed towards the left ventricle and the delivery system proximal to the fossa ovalis is moved upwards in the right atrium.