Delivery device and methods of use for transapical delivery of replacement mitral valve

• US 10,575,951 B2
• Filed: 08/19/2016
• Issued: 03/03/2020
• Est. Priority Date: 08/26/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Johnson, Garrett Dallas, Landon, David Robert, Lam, Lindsay, Rabito, Glen T., Cooper, Alexander H.
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US15/242,297
• Publication Number:
  US 20170056169A1
• Time in Patent Office: 1,292 Days
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics

Abstract

Devices, systems and methods are described for implantation of a prosthesis within a lumen or body cavity and delivery systems for delivering the prosthesis to a location for implantation. A delivery system can include a tether connected to a single directional handle knob for release of the prosthesis within the lumen or body cavity and retraction of the tether towards the handle.

Claims

1. A delivery system for controlled deployment of a collapsible implant, the delivery system comprising:

a handle at a proximal end of the delivery system, the handle comprising a tether control knob configured to control movement of a tether extending distally away from the handle; and

an outer hollow member operably connected to the handle configured to at least partially restrain the implant in a collapsible configuration, wherein the tether extends through the outer hollow member to engage the implant when the implant is positioned within the outer hollow member, the outer hollow member being moveable relative to the implant to expose the implant at a body location while the tether keeps the implant radially restrained;

an inner shaft extending through the outer hollow member;

a tether retention member located on the inner shaft proximal to where the tether engages the implant, the tether retention member configured to hold a free end of the tether;

a locking shaft slidable over the inner shaft and the tether retention member;

a block located within the handle and proximal of the tether control knob, the block attached to a proximal end of the locking shaft;

wherein rotation of the tether control knob in a single direction initially unspools the tether for allowing radial expansion of the implant;

wherein after the radial expansion of the implant, further rotation of the tether control knob in the single direction translates a screw in the handle proximally to translate the block and the locking shaft proximally away from the tether retention member to release the free end of the tether; and

wherein after the release of the free end of the tether, further rotation of the tether control knob in the single direction retracts the tether proximally through the outer hollow member toward the handle and respools the tether.

2. The delivery system of claim 1, wherein the tether is configured to unspool and spool in a cavity within the tether control knob.

3. The delivery system of claim 1, further comprising a replacement valve located within a distal portion of the outer hollow member, wherein the tether wraps around the replacement valve to prevent expansion of the replacement valve.

4. The delivery system of claim 1, wherein the tether retention member comprises a c-lock, the c-lock having a longitudinal slot covered by the locking shaft, the slot retaining the free end of the tether.

5. The delivery system of claim 4, further comprising a centering ring on the locking shaft to center the locking shaft within the outer hollow member, the centering ring comprising at least one aperture through which the tether passes.

6. The delivery system of claim 1, wherein the handle comprises an auditory or visual indicator to provide a user a signal indicating a position of the tether.

7. A delivery system for controlled deployment of a collapsible replacement heart valve, the delivery system comprising:

a handle comprising an outer housing and a generally tubular shaped sleigh located at least partially within the outer housing and received within a proximal end of the outer housing, the sleigh having a hollow interior;

a first elongate shaft operably connected to the housing and configured to cover at least a proximal end of the collapsible replacement heart valve;

a second elongate shaft located within the first elongate shaft and operably connected to the hollow interior of the sleigh at a proximal end of the second elongate shaft;

a third elongate shaft located within the second elongate shaft and operably connected to the hollow interior of the sleigh at a proximal end of the third elongate shaft;

a fourth elongate shaft located within the third elongate shaft and having a nose cone on a distal end thereof, the nose cone configured to radially restrain a distal end of the collapsible replacement heart valve, the fourth elongate shaft is operably connected to the hollow interior of the sleigh at a proximal end of the fourth elongate shaft; and

a single flush port exposed outside of the handle, wherein the single flush port is fluidly connected to the first elongate shaft, the second elongate shaft, and the third elongate shaft;

wherein the sleigh is configured to translate relative to the housing from a distal to a proximal position, wherein translation of the sleigh from the distal to the proximal position translates the second, third, and fourth elongate shafts proximally in one motion so that the second, third, and fourth elongate shafts remain in the same position relative to one another in the distal and proximal position during the in one motion translation of the sleigh from the distal to the proximal position; and

wherein the handle comprises a sleigh lock configured to prevent motion of the sleigh upon activation of the lock.

8. The delivery system of claim 7, further comprising a first shaft knob configured to translate the first elongate shaft distally and proximally, a second shaft knob configured to translate the second elongate shaft distally and proximally, and a fourth shaft knob configured to translate the fourth shaft distally and proximally, wherein each of the shaft knobs can move their respective shafts independent of one another.

9. The delivery system of claim 7, wherein the sleigh extends proximally from the handle in the proximal position.

10. A delivery system for controlled deployment of a collapsible replacement heart valve, the delivery system comprising:

a handle comprising an outer housing and a generally tubular shaped sleigh located at least partially within the outer housing and received within a proximal end of the outer housing, the sleigh having a hollow interior;

a first elongate shaft operably connected to the housing and configured to cover at least a proximal end of the collapsible replacement heart valve;

a first shaft knob configured to translate the first elongate shaft distally and proximally;

a second elongate shaft located within the first elongate shaft and operably connected to the hollow interior of the sleigh at a proximal end of the second elongate shaft;

a second shaft knob configured to translate the second elongate shaft distally and proximally;

a third elongate shaft located within the second elongate shaft and operably connected to the hollow interior of the sleigh at a proximal end of the third elongate shaft;

a fourth elongate shaft located within the third elongate shaft and having a nose cone on a distal end thereof, the nose cone configured to radially restrain a distal end of the collapsible replacement heart valve, the fourth elongate shaft is operably connected to the hollow interior of the sleigh at a proximal end of the fourth elongate shaft;

a fourth shaft knob configured to translate the fourth shaft distally and proximally, wherein each of the first shaft knob, the second shaft knob, and the fourth shaft knob are configured to move their respective shafts independent of one another; and

a single flush port exposed outside of the handle, wherein the single flush port is fluidly connected to the first elongate shaft, the second elongate shaft, and the third elongate shaft;

wherein the sleigh is configured to translate relative to the housing from a distal to a proximal position, wherein translation of the sleigh from the distal to the proximal position translates the second, third, and fourth elongate shafts proximally in one motion so that the second, third, and fourth elongate shafts remain in the same position relative to one another in the distal and proximal position during the in one motion translation of the sleigh from the distal to the proximal position.

11. The delivery system of claim 10, wherein the handle comprises a sleigh lock configured to prevent motion of the sleigh upon activation of the lock.

12. The delivery system of claim 10, wherein the sleigh extends proximally from the handle in the proximal position.