Treatment catheter member with encircling function

• US 10,470,884 B2
• Filed: 03/02/2017
• Issued: 11/12/2019
• Est. Priority Date: 03/06/2012
• Status: Active Grant

• Current Assignee: HighLife SAS
• Original Assignee: HighLife SAS
• Inventors: Bortlein, Georg, Nasr, Malek
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/448,020
• Publication Number:
  US 20170172554A1
• Time in Patent Office: 985 Days
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00845 of moving parts with respect to each other
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A catheter member for interacting with a circumferential tissue structure includes: an elongate primary catheter having at least one inner lumen and extending along a longitudinal axis; first and second elongate secondary catheters, each having an inner lumen, and each positionable in an inner lumen of the primary catheter to be moveable relatively thereto and exposable therefrom; and a first flexing mechanism to provide a distal end portion of the first and/or second secondary catheter with a tendency to assume a first secondary bent shape. The distal end portion of the first and/or second secondary catheters is provided so as to be able to be flexed by the first flexing mechanism to form an arm portion substantially transverse to the direction of the longitudinal axis of the primary catheter so as to assume the first secondary bent shape when exposed from a distal end portion of the primary catheter.

Claims

1. A catheter member for interacting with a circumferential tissue structure comprising:

an elongate primary catheter which has at least one inner lumen and which extends along a longitudinal axis and has a distal end portion and a proximal end portion,

first and second elongate secondary catheters each extending along a longitudinal axis, each comprising a distal end portion and a proximal end portion and an inner lumen, and each comprising a secondary alignment portion, which is located between the distal and proximal end portions and adjacent to the distal end portion, and each positionable in an inner lumen of the primary catheter to be moveable relatively thereto and exposable therefrom,

a first flexing mechanism to provide the distal end portion of the first and/or second secondary catheter with a tendency to assume a first secondary bent shape, and

a second flexing mechanism to provide the secondary alignment portion of the first and/or second secondary catheter with a tendency to assume a second secondary bent shape,

wherein

the distal end portion of at least one of the first and second secondary catheters is configured to be able to be flexed by the first flexing mechanism to form an arm portion substantially transverse to the direction of the longitudinal axis of the primary catheter so as to assume the first secondary bent shape, when being exposed from the distal end portion of the primary catheter,

the secondary alignment portion of at least one of the first and second secondary catheters is configured to be able to be flexed by the second flexing mechanism to assume the second secondary bent shape having a predetermined curvature, optionally with a radius of substantially 30 to 70 mm and optionally describing an angle of 90°

to 270°

,

the arm portions of the first and second secondary catheters, respectively, extend in different directions to each other when the secondary alignment portions of the first and second secondary catheters assume the second secondary bent shape in parallel to each other,

the primary catheter is provided with a radial opening having a distance to the distal end portion and the proximal end portion thereof, and

the catheter member further comprises a catching device configured to be at least partially sheathed in the inner lumen of the primary catheter member to be moveable thereto and to be at least partially exposable from the primary catheter via the opening.

2. The catheter member according to claim 1, further comprising first and/or second elongate tertiary catheters to be guided by the first and/or second secondary catheters, respectively, each extending along a longitudinal axis and each comprising a distal end portion and a proximal end portion and each to be moveable relatively to the first and/or second secondary catheters, respectively, and exposable from the distal end portions thereof.

3. The catheter member according to claim 2, wherein the first and/or second tertiary catheters each has a first and/or a second tertiary alignment portion between the respective distal and proximal end portions thereof, each with a shape-memory structure providing the first and/or the second tertiary alignment portions with a tendency to assume a first and/or a second tertiary bent shape, respectively, corresponding to the first and/or to the second secondary bent shape, respectively.

4. The catheter member according to claim 3, wherein the shape-memory structure of the distal end portions of the first and the second tertiary catheters is such that, when, the first and/or the second tertiary alignment portion of the first and the second tertiary catheters are located so as to mate with the distal end portions and/or the secondary alignment portions of the first and second secondary catheter, assuming their respective first and/or second bent shape, respectively, the distal end portions of the first and the second tertiary catheters are provided with a tendency to assume bow shapes extending oppositely towards each other so as to form a loop-shape.

5. The catheter member according to claim 4, wherein, when the first and second distal end portions of the first and second tertiary catheter are exposed from the distal end portion of the first and second secondary catheters, the distal end portions of the first and second tertiary catheters each substantially extend in a substantially same plane that is transverse to the longitudinal axis of the primary catheter.

6. The catheter member according to claim 3, wherein, when the first and/or the second tertiary alignment portion of the first and the second tertiary catheters are located so as to mate with the distal end portions and/or the secondary alignment portions of the first and second secondary catheter, assuming their respective first and/or second bent shape, respectively, the distal end portions of the first and the second tertiary catheters are fully operatively exposed from the distal end portions of the first and second secondary catheters.

7. The catheter member according to claim 3, wherein the shape-memory structure is provided by material elasticity.

8. The catheter member according to claim 2, wherein the distal end portions of the first and the second tertiary catheters comprise a shape-memory structure providing them with a tendency to assume a respective bow shape when being exposed from the distal end portion of the first and second secondary catheters, respectively.

9. The catheter member according to claim 2, wherein

the first and second tertiary catheters each comprises an inner lumen,

a wire having a free distal end is provided in the inner lumen of the first tertiary catheter and a catching wire optionally with a catching component on a distal end thereof is provided in the inner lumen of the second tertiary catheter, and

both the wire and the catching wire are provided to be movable relative to their respective tertiary catheter and exposable from and retractable into a distal end portion thereof, so that the free distal end of the wire can be caught with the catching component so as to form a loop.

10. The catheter member according to claim 9, wherein the catching component is a catching basket and/or a lasso and/or a snare.

11. The catheter member according to claim 9, wherein

the wire and/or the catching wire has a shape memory structure giving it a tendency to assume a bow shape,

a strength of the shape memory structure of the wire and/or the catching wire is higher than a strength of a shape memory structure of the distal end portion of the first and/or second tertiary catheter so that the wire and/or catching wire unwinds a coil shape of the distal end portion of the first and/or second tertiary catheter when forwarded through the first and/or second tertiary catheter so that the distal end portion of the first and/or second tertiary catheter assumes the bow-shape of the wire and/or catching wire, and

optionally the catching wire does not comprise a catching component.

12. The catheter member according to claim 9, wherein the catching device is configured to catch a respective free distal end of the wire and/or the catching wire and/or to catch the loop, optionally when the first and/or second secondary catheter has assumed the second secondary bent shape, and to move said caught distal end or distal ends or loop with respect to the primary catheter.

13. The catheter member according to claim 12, wherein

the catching device is connected to a distal longitudinal end of a control wire, and a control catheter having an inner lumen that is provided in the primary catheter to be moveable relatively thereto and to be exposable via the opening,

the control wire and the catching device are configured to be at least partially sheathed in the inner lumen of control catheter to be relatively moveable thereto, and

the catching device is forwardable from and retractable into the inner lumen of the control catheter to be exposed or sheathed, respectively.

14. The catheter member according to claim 13, wherein the catching device comprises a catching basket, a magnetic component, a hook, a snare and/or a lasso.

15. The catheter member according to claim 2, wherein one or both of the first and second tertiary catheters are received in the inner lumen of the first and second secondary catheter, respectively, so as to be guided by them.

16. The catheter member according to claim 2, wherein

the first and/or second tertiary catheter comprises an inner lumen, and

one or both of the first and second secondary catheter, respectively, are received in the inner lumen of the first and/or second tertiary catheter, respectively, so that the first and/or second tertiary catheter are guided by the first and/or second secondary catheter, respectively.

17. The catheter member according to claim 2, wherein

the distal end portion of the first and/or second tertiary catheter has a shape memory structure giving it a tendency to assume a coil shape having a plurality of windings, at least when the distal end portion of the first and/or second tertiary catheter is exposed from the distal end portion of the first and/or second secondary catheter, respectively, and

optionally the coil shape of the distal end portion of the first and/or second tertiary catheter is diametrically compressed when sheathed in the inner lumen of the first and/or second secondary catheter.

18. The catheter member according to claim 17, wherein

a wire having a free distal end is provided in the inner lumen of the first tertiary catheter and/or a catching wire optionally with a catching component on a distal end thereof is provided in the inner lumen of the second tertiary catheter,

the wire and/or the catching wire has a shape memory structure giving it a tendency to assume a bow shape, and

a strength of the shape memory structure of the wire and/or the catching wire is higher than a strength of the shape memory structure of the distal end portion of the first and/or second tertiary catheter so that the wire and/or catching wire unwinds the coil shape of the distal end portion of the first and/or second tertiary catheter when forwarded through the first and/or second tertiary catheter so that the distal end portion of the first and/or second tertiary catheter assumes the bow-shape of the wire and/or catching wire.

19. The catheter member according to claim 1, wherein the curvature of the second secondary bent shape is configured to mate the curvature of an aortic arch of a mammal heart and the circumferential tissue structure is part or all of the mitral valve apparatus.

20. The catheter member according to claim 1, wherein the curvature of the second secondary bent shape is configured to mate the curvature of a connection channel from the superior vena cava to the pulmonary artery of a mammal heart and the circumferential tissue structure is part or all of the tricuspid valve apparatus.

21. The catheter member according to claim 1, wherein

the primary catheter further comprises a front body tube moveably disposed in its inner lumen, and

the front body tube comprises a blunt front body on its distal end portion that is configured to selectively open and close the distal, end portion of the primary catheter by movement of the front body tube in a distal or proximal direction, respectively, of the primary catheter.

22. The catheter member according to claim 1, wherein

the first flexing mechanism and/or the second flexing mechanism comprise a shape-memory structure, a flexing structure having an atraumatic nose cone and/or threads attached to the distal end portion of the first and/or second secondary catheter and/or a hinge member rotatably connecting first and second secondary catheters and an inflatable member that is provided between the first and second secondary catheters, and/or at least one link member and at least two joint members interconnecting first and second secondary catheters, and/or at least two link members and at least three joint members and a longitudinal operation member that is movable in a longitudinal direction of primary catheter,

the first secondary catheter is connected to a first link member via a first joint member, the second secondary catheter is connected to a second link member via a second joint member and the first and second link members are connected via a third joint member, and

the third joint member or the first link member or the second link member is connected to the operation member to be movable in the longitudinal direction of primary catheter.

23. The catheter member according to claim 1, wherein the respective arm portion extends at least 5 mm or at least 8 mm or at least 10 mm or at least 12 mm in a direction radial to the longitudinal axis of primary catheter with a free end of the respective arm portion facing away from the longitudinal axis so that the respective arm forms a blunt end face extending transversely to the longitudinal axis of the primary catheter and allowing to frontally contact the tissue structure with the catheter member in a non-penetrating manner.

24. The catheter member according to claim 1 in combination with an implant, wherein one or both of the first and second tertiary catheters is/are configured so as to deliver the implant to the circumferential tissue structure.