Cardiac implant delivery system

• US 10,426,616 B2
• Filed: 11/17/2016
• Issued: 10/01/2019
• Est. Priority Date: 11/17/2016
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Prabhu, Santosh V.
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US15/354,644
• Publication Number:
  US 20180133007A1
• Time in Patent Office: 1,048 Days
• CPC Class Codes: A61B 2090/066 for measuring torque
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• 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 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

The present disclosure relates to delivery systems for delivering and deploying interventional devices to a targeted area within a body, such as delivering a replacement heart valve to a targeted heart valve. A delivery device includes a steerable catheter and a replacement valve delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter. The steerable catheter includes one or more control wires running from a distal end of the catheter to a handle at the proximal end of the catheter. Each control wire is coupled to a control of the handle such that manipulation of the control provides deflection and control of the steerable catheter.

Claims

1. A delivery system configured for delivering an interventional device to a targeted treatment area within a body, the delivery system comprising:

a steerable catheter having a proximal end and a distal end; and

an interventional device delivery system positioned within the steerable catheter and configured to be translatable within the steerable catheter so as to selectively deploy the interventional device beyond the distal end of the steerable catheter, the interventional device delivery system comprising;

a shaft; and

a sheath operatively coupled to the shaft, the sheath having a first portion, a second portion, and a space defined by the first portion and the second portion, the first portion of the sheath enclosing a first portion of the interventional device, the second portion of the sheath enclosing a second portion of the interventional device, and the first and second portions of the sheath being selectively moveable relative to one another and relative to the interventional device so as to;

selectively deploy the first portion of the interventional device from the sheath while maintaining the second portion of the interventional device within the sheath, or

alternatively, selectively deploy the second portion of the interventional device from the sheath while maintaining the first portion of the interventional device within the sheath, and

once one portion of the interventional device is deployed and positioned at the targeted treatment area, move the other portion of the sheath to selectively deploy the other portion of the interventional device,

wherein a portion of the sheath is translatable upon subjection to a hydraulic force, from a fluid ejected into the space enclosing the interventional device prior to the sheath separating to deploy the interventional device, to deploy one of the first portion or the second portion of the interventional device.

2. The delivery system of claim 1, wherein at least a portion of the steerable catheter includes a notch, and wherein at least a portion of the interventional device delivery system includes a corresponding extension lodging within the notch to lock rotation of the interventional device delivery system with respect to the steerable catheter.

3. The delivery system of claim 1, wherein the interventional device delivery system includes a distal tip enclosing a distal section of a replacement heart valve, as the interventional device, and includes a proximal sheath enclosing a proximal section of the replacement heart valve, the distal tip being distally translatable relative to the replacement heart valve, and the proximal sheath being proximally translatable relative to the replacement heart valve.

4. The delivery system of claim 3, wherein the distal tip is distally translatable upon subjection to a distally oriented hydraulic force to deploy the distal section of the replacement heart valve, and wherein the proximal sheath is proximally translatable to deploy the proximal section of the replacement heart valve.

5. The delivery system of claim 1, wherein the sheath defines an inter-luminal space through which at least a portion of the shaft extends, and wherein the shaft includes a plurality of fluid ports enabling the passage of fluid into the inter-luminal space so as to cause at least a portion of the sheath to translate proximally relative to the interventional device to deploy the interventional device.

6. The delivery system of claim 5, wherein the sheath includes a proximal wall that defines the proximal extent of the inter-luminal space, the proximal wall enabling the sheath to be translated proximally as a result of a hydraulic force imparted by the fluid.

7. The delivery system of claim 1, wherein the interventional device delivery system includes a tether detachably coupled to the interventional device, the tether and the interventional device forming a magnetic coupling upon passage of electric current through the tether, the tether being selectively decoupled from the replacement heart valve upon cessation of the electric current.

8. The delivery system of claim 1, wherein the interventional device delivery system includes a tether detachably coupled to the interventional device, the tether including a meltable portion and a heat-transmitting portion such that the transmission of heat through the heat-transmitting portion causes sufficient melting of the meltable portion to decouple the tether from the interventional device.

9. The delivery system of claim 1, wherein the steerable catheter includes one or more control wires, each control wire coupled to a control of the handle and to the distal end of the steerable catheter such that tensioning of the control wire causes corresponding deflection of the steerable catheter, wherein the one or more control wires are formed from a titanium or titanium alloy material and have an ultimate tensile strength within a range of 700 to 1500 MPa.

10. The delivery system of claim 1 further comprising a handle coupled to the proximal end of the steerable catheter, the handle having one or more controls and one or more corresponding steering mechanisms enabling steering of the steerable catheter.

11. The delivery system of claim 10, wherein the handle includes a rotatable control operatively coupled to a control wire tensioning wheel through a gear assembly, the gear assembly being arranged so that rotation of the wire tensioning wheel relative to rotation of the rotatable control is reduced by a factor greater than 8.

12. The delivery system of claim 10, wherein the handle includes a motor configured to provide motor-assisted tensioning of one or more control wires.

13. The delivery system of claim 1, wherein the steerable catheter includes a plurality of cuts arranged to enable one or more of preferential bending or increased flexibility of the steerable catheter.

14. A delivery system configured for delivering a replacement heart valve to a targeted heart valve within a body, the delivery system comprising:

a catheter configured to house a deployable replacement valve, the catheter having a proximal end and a distal end;

a distal tip enclosing a distal section of the replacement valve, the distal tip being distally translatable relative to the replacement valve; and

a sheath enclosing a proximal section of the replacement valve, the sheath being proximally translatable relative to the replacement valve, the distal tip and the sheath forming a space for the replacement heart valve,

wherein the distal tip is distally translatable upon subjection to a distally oriented hydraulic force, from a fluid ejected into and filling the space of the sheath in a closed state in which the sheath is enclosing the replacement valve, to deploy the distal section of the replacement valve, and

wherein the sheath is proximally translatable to deploy the proximal section of the replacement valve.

15. The delivery system of claim 14, wherein the interventional device delivery system includes a tether detachably coupled to the replacement heart valve, the tether and the replacement heart valve forming a magnetic coupling upon passage of electric current through the tether, the tether being selectively decoupled from the replacement heart valve upon turning off the electric current.

16. The delivery system of claim 14, wherein the interventional device delivery system includes a tether detachably coupled to the replacement heart valve, the tether including a meltable portion and a heat-transmitting portion such that the transmission of heat through the heat-transmitting portion causes sufficient melting of the meltable portion to decouple the tether from the replacement heart valve.

17. A delivery system configured for delivering a replacement heart valve to a targeted heart valve within a body, the delivery system comprising:

a catheter configured to house a deployable replacement valve, the catheter having a proximal end and a distal end; and

a sheath enclosing the replacement heart valve, the sheath also defining an inter-luminal space through which at least a portion of a shaft extends, the shaft including a plurality of fluid ports enabling the passage of fluid into the inter-luminal space so as to cause the sheath to translate proximally relative to the replacement heart valve to deploy the replacement heart valve, the inter-luminal space receiving the fluid from the plurality of fluid ports also includes the replacement heart valve, the fluid being present within the inter-luminal space prior to the sheath translating proximally relative to the replacement heart valve to deploy the replacement heart valve.

18. The delivery system of claim 17, wherein the sheath includes a proximal wall that defines the proximal extent of the inter-luminal space, the proximal wall enabling the sheath to be translated proximally as a result of a hydraulic force imparted by the fluid.

19. The delivery system of claim 17, wherein the interventional device delivery system includes a tether detachably coupled to the replacement heart valve, the tether and the replacement heart valve forming a magnetic coupling upon passage of electric current through the tether, the tether being selectively decoupled from the replacement heart valve upon turning off the electric current.

20. The delivery system of claim 17, wherein the interventional device delivery system includes a tether detachably coupled to the replacement heart valve, the tether including a meltable portion and a heat-transmitting portion such that the transmission of heat through the heat-transmitting portion causes sufficient melting of the meltable portion to decouple the tether from the replacement heart valve.