Translation catheters, systems, and methods of use thereof

• US 10,682,232 B2
• Filed: 07/06/2017
• Issued: 06/16/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Goodwin, Jonathan, Sutherland, Michael, House, Morgan, Morrill, Richard, Guimond, Matt, Lee, Christopher, Cutuli, Kate, Douk, Nareak
• Primary Examiner(s): Matthews, Christine H
• Application Number:
  US15/642,963
• Publication Number:
  US 20180125659A1
• Time in Patent Office: 1,076 Days
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

The present teachings generally relate to translation catheter systems and method of using thereof in treating defective mitral valves. Specifically, a translation catheter system includes a catheter configured to move substantially laterally along the mitral annulus and the lateral movement of the catheter is substantially continuous and substantially adjustable. Accordingly, a method of using such a translation catheter includes advancing a first wire across the mitral annulus at a first treatment location, delivering a catheter at or near the first treatment location, moving the catheter substantially laterally to a second treatment location, and advancing a second wire across the mitral annulus, where the distance between the first and second treatment locations is substantially adjustable and optionally visualized.

Claims

1. A catheter system comprising:

a first wire configured to be positioned at a first location;

a translatable catheter configured to be positioned at a second location and be movable between a first position at which the translatable catheter is at or proximate the first location and a second position at which the translatable catheter is at the second location; and

a translation element configured to move the translatable catheter from the first position to the second position in a substantially linear fashion, while the first wire is maintained at the first location,

wherein;

the translation element comprises a tether that is coupled at one end to the first wire and passes through the translatable catheter and is accessible to a user to permit manipulation of the tether to cause the translatable catheter to move between the first and second positions, and

the translatable catheter has a preformed curved portion proximate a distal end thereof, and a second tether is attached to the preformed curved portion and is manipulable to cause actuation of the preformed curved portion resulting in the preformed curved portion assuming a preformed curved shape.

2. The catheter system of claim 1, wherein the first wire is disposed within an other catheter that is separate from the translatable catheter, wherein both the first wire and the translatable catheter are slidingly contained within lumens formed in a delivery sheath.

3. The catheter system of claim 2, wherein the translation element operably connects the other catheter and the translatable catheter and permits the translatable catheter to move away from the other catheter from the first position to the second position.

4. The catheter system of claim 2, wherein the one end of the tether is a free end that wraps around the other catheter.

5. The catheter system of claim 2, wherein the one end of the tether is a fixed end that is connected with the other catheter.

6. The catheter system of claim 5, wherein the tether further comprises a free end and the free end extends into a lumen of the translatable catheter and is accessible by the user.

7. The catheter system of claim 6, wherein the translatable catheter includes a side opening formed therealong, the free end of the tether passing through the side opening into the lumen of the translatable catheter.

8. The catheter system of claim 6, wherein the translatable catheter includes a side opening formed therealong and spaced from the distal end of the translatable catheter, wherein the distal end is an open distal end, the free end of the tether passing through the open distal end of the translatable catheter and along the lumen thereof before exiting through the side opening and being routed longitudinally along an outer surface of the translatable catheter.

9. The catheter system of claim 2, wherein the preformed curved portion is formed of a memory material such that the preformed curved portion is elastically recoverable to assume the preformed curved shape.

10. The catheter system of claim 1, further comprising a tracking element that is configured to track over and move longitudinally along the first wire, the translation element being coupled to the tracking element.

11. The catheter system of claim 1, wherein a distance between the first location and the second location is adjustable.

12. A catheter system comprising:

a first catheter configured to be positioned at a first treatment location;

a second catheter configured to be positioned at a second treatment location;

a sheath that has a first lumen in which the first catheter is disposed and a second lumen in which the second catheter is disposed; and

a translation mechanism operably connecting the first and second catheters, the translation mechanism being configured and actuatable to allow the second catheter to move laterally away from the first catheter for a prescribed distance so as to space the second catheter from the first catheter and position the second catheter at the second treatment location,

wherein;

the sheath is formed such that a distal end portion thereof includes a side slot that extends longitudinally and defines an entrance into the second lumen and allows the second catheter, upon actuation of the translation mechanism, to pass therethrough and extend radially outward from the distal end portion and be positioned at the second treatment location,

the sheath further includes first and second steering wire lumens that receive first and second steering wires, respectively, each of the first and second steering wires including a longitudinal wire with a wire coil being wrapped around the longitudinal wire, and

distal ends of the longitudinal wire and the wire coil of each of the first and second steering wires are attached to one another and are attached to a distal end of the sheath.

13. The catheter system of claim 12, further comprising a control handle that is coupled to the sheath, and wherein, for each of the first and second steering wires, a proximal end of the wire coil is fixed to the control handle and a proximal end of the longitudinal wire is configured to be retracted inside a helix defined by the wire coil.

14. The catheter system of claim 12, wherein the translation mechanism comprises a pusher assembly which travels longitudinally and causes the second catheter to pass through the side slot and extend radially outward from the distal end portion and be positioned at the second treatment location.

15. A catheter system comprising:

a first catheter configured to be positioned at a first treatment location;

a second catheter configured to be positioned at a second treatment location;

a sheath that has a first lumen in which the first catheter is disposed and a second lumen in which the second catheter is disposed; and

a translation mechanism operably connecting the first and second catheters, the translation mechanism being configured and actuatable to allow the second catheter to move laterally away from the first catheter for a prescribed distance so as to space the second catheter from the first catheter and position the second catheter at the second treatment location,

wherein;

the sheath is formed such that a distal end portion thereof includes a side slot that extends longitudinally and defines an entrance into the second lumen and allows the second catheter, upon actuation of the translation mechanism, to pass therethrough and extend radially outward from the distal end portion and be positioned at the second treatment location, and

the translation mechanism comprises a pusher assembly which travels longitudinally and causes the second catheter to pass through the side slot and extend radially outward from the distal end portion and be positioned at the second treatment location.

16. The catheter system of claim 15, wherein the sheath further includes first and second steering wire lumens that receive first and second steering wires, respectively, each of the first and second steering wires including a longitudinal wire with a wire coil being wrapped around the longitudinal wire, wherein distal ends of the longitudinal wire and the wire coil of each of the first and second steering wires are attached to one another and are attached to a distal end of the sheath.

17. The catheter system of claim 16, further comprising a control handle that is coupled to the sheath, and wherein, for each of the first and second steering wires, a proximal end of the wire coil is fixed to the control handle and a proximal end of the longitudinal wire is configured to be retracted inside a helix defined by the wire coil.

18. A catheter system comprising:

a delivery sheath;

a first wire configured to be positioned at a first location;

a translatable catheter configured to be positioned at a second location and be movable between a first position at which the translatable catheter is at or proximate the first location and a second position at which the translatable catheter is at the second location;

an other catheter that is separate from the translatable catheter, the first wire being disposed within the other catheter; and

a translation element configured to move the translatable catheter from the first position to the second position in a substantially linear fashion, while the first wire is maintained at the first location, the translation element comprising a tether having;

a fixed end that is connected with a catheter selected from the group consisting of the translatable catheter and the other catheter, and

a free end that extends into a lumen of the translatable catheter and is accessible by a user,

wherein both the first wire and the translatable catheter are slidingly contained within lumens formed in the delivery sheath.

19. The catheter system of claim 18, wherein the translation element operably connects the other catheter and the translatable catheter and permits the translatable catheter to move away from the other catheter from the first position to the second position.

20. The catheter system of claim 18, wherein the translatable catheter includes a side opening formed therealong, the free end of the tether passing through the side opening into the lumen of the translatable catheter.

21. The catheter system of claim 18, wherein the translatable catheter includes a side opening formed therealong and spaced from an open distal end of the translatable catheter, the free end of the tether passing through the open distal end of the translatable catheter and along the lumen thereof before exiting through the side opening and being routed longitudinally along an outer surface of the translatable catheter.

22. The catheter system of claim 18, wherein the translatable catheter has a preformed curved portion proximate a distal end thereof, the preformed curved portion being formed of a memory material such that the curved portion is elastically recoverable to assume a preformed curved shape.

23. The catheter system of claim 18, wherein the translatable catheter has a preformed curved portion proximate a distal end thereof, and a second tether is attached to the preformed curved portion and is manipulable to cause actuation of the preformed curved portion resulting in the preformed curved portion assuming a preformed curved shape.

24. The catheter system of claim 18, wherein a distal end of the translatable catheter is attached to a distal end of the other catheter and the translatable catheter has a plurality of side openings formed along a length thereof which permit the translatable catheter to bend, wherein a second wire passes through one of the side openings to the second location.

25. The catheter system of claim 18, further comprising a tracking element that is configured to track over and move longitudinally along the first wire, the translation element being coupled to the tracking element.

26. The catheter system of claim 18, wherein a distance between the first location and the second location is adjustable.

27. The catheter system of claim 18, wherein the selected catheter is the other catheter, and the fixed end of the tether is connected to the other catheter.