ANCHORING DELIVERY SYSTEM AND METHODS

• US 20180028205A1
• Filed: 10/06/2017
• Published: 02/01/2018
• Est. Priority Date: 07/24/2015
• Status: Active Grant

• Current Assignee: Route 92 Medical, Inc.
• Original Assignee: Route 92 Medical, Inc.
• Inventors: Chou, Tony M., English, Joey, Wilson, Scott D., Valley, Kirsten, Evard, Philip
• Granted Patent: US 11,224,449 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/22049 Means for locking the guide wire in the catheter
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An anchoring delivery system for use in an intracranial artery is provided including a tethering device having an elongated tether and an anchor coupled to a distal end of the tether. The anchor is deployable from a low profile configuration to a higher profile configuration to fix the distal end of the tether at an anchoring site in an anchoring vessel. The tethering device is configured to be used with a guide-sheath having a lumen configured to receive the tether. Related devices, systems, and methods are also described.

Claims

1. An enhanced flexibility neurovascular catheter, comprising:

an elongate flexible body, having a proximal end, a distal end and a side wall defining a central lumen, a proximal zone and a distal zone separated by a transition, the distal zone having a side wall comprising;

a tubular inner liner;

a tie layer separated from the lumen by the inner liner;

a helical coil surrounding the tie layer, adjacent windings of the coil spaced progressively further apart in the distal direction; and

an outer jacket surrounding the helical coil, the outer jacket formed from a plurality of tubular segments positioned coaxially about the coil;

wherein

the distal zone increases in flexibility in the distal direction, a proximal one of the tubular segments has a durometer of at least about 60D and a distal one of the tubular segments has a durometer of no more than about 35D; and

the proximal zone comprises a tubular braid wrapped around the tubular inner liner.

2. An enhanced flexibility neurovascular catheter as in claim 1, wherein the tubular inner liner comprises polytetrafluoroethylene.

3. An enhanced flexibility neurovascular catheter as in claim 1, wherein the coil comprises a shape memory material.

4. An enhanced flexibility neurovascular catheter as in claim 3, wherein the coil comprises Nitinol.

5. An enhanced flexibility neurovascular catheter as in claim 1, wherein the outer jacket is formed from at least five discrete tubular segments.

6. An enhanced flexibility neurovascular catheter as in claim 5, wherein the difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D.

7. An enhanced flexibility neurovascular catheter as in claim 5, wherein the difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 30D.

8. A neurovascular catheter, comprising:

an elongate flexible body having a proximal end region, a distal end region, and a working lumen, the proximal end region and the distal end region separated by a transition, the distal end region having a side wall comprising;

a tubular inner liner having an outer surface coated with a compound suitable for bonding;

a first reinforcement structure that is a helical coil bonded to the coated outer surface of the tubular inner liner, wherein pitch of the helical coil increases in the distal direction; and

an outer jacket surrounding the helical coil, the outer jacket formed from a plurality of tubular segments,

wherein the distal end region increases in flexibility in the distal direction, and

wherein a first of the plurality of tubular segments has a durometer of at least about 60D and a second of the plurality of tubular segments distal to the first has a durometer of about 35D; and

a side wall of the proximal end region comprising a second reinforcement structure bonded to the coated outer surface of the tubular inner liner, wherein the second reinforcement structure is structurally different from the first reinforcement structure.

9. A neurovascular catheter as in claim 8, wherein the tubular inner liner comprises polytetrafluoroethylene.

10. A neurovascular catheter as in claim 8, wherein the helical coil comprises a shape memory material.

11. A neurovascular catheter as in claim 10, wherein the helical coil comprises Nitinol.

12. A neurovascular catheter as in claim 8, wherein the outer jacket is formed from at least five discrete tubular segments.

13. A neurovascular catheter as in claim 8, wherein the outer jacket is formed from more than five discrete tubular segments.

14. A neurovascular catheter as in claim 8, wherein a difference in durometer between a proximal one of the plurality of tubular segments and a distal one of the plurality of tubular segments is at least about 20D.

15. A neurovascular catheter as in claim 8, wherein a difference in durometer between a proximal one of the plurality of tubular segments and a distal one of the plurality of tubular segments is at least about 30D.

16. A neurovascular catheter extension segment, comprising:

an elongate flexible control wire, having a proximal end and a distal end;

a tubular extension segment having a side wall defining a central lumen carried by the distal end of the control wire;

the side wall comprising;

a tubular inner liner;

a tie layer separated from the lumen by the inner liner;

a helical coil surrounding the tie layer; and

an outer jacket surrounding the helical coil.

17. A neurovascular catheter extension segment as in claim 16, wherein the outer jacket is formed from a plurality of tubular segments positioned coaxially about the coil.

18. A neurovascular catheter extension segment as in claim 17, wherein a proximal one of the tubular segments has a durometer of at least about 60D and a distal one of the tubular segments has a durometer of no more than about 35D.

19. A neurovascular catheter extension segment as in claim 16, wherein the tubular liner comprises polytetrafluoroethylene.

20. A neurovascular catheter extension segment as in claim 16, wherein the coil comprises a shape memory material.

21. A neurovascular catheter extension segment as in claim 20, wherein the coil comprises Nitinol.

22. A neurovascular catheter extension segment as in claim 17, wherein the outer jacket is formed from at least five discrete tubular segments.

23. A neurovascular catheter extension segment as in claim 22, wherein the difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D.

24. A neurovascular catheter extension segment as in claim 23, wherein the difference is at least about 30D.

25. A neurovascular catheter extension segment as in claim 16, wherein the control wire comprises a central lumen.

26. A neurovascular catheter extension segment as in claim 25, wherein the inside diameter of the neurovascular catheter extension segment is at least 2×

the inside diameter of the control wire central lumen.

27. A neurovascular catheter extension segment as in claim 26, wherein the inside diameter of the neurovascular catheter extension segment is at least 3×

the inside diameter of the control wire central lumen.

28. A neurovascular catheter extension segment, comprising:

a proximal, elongate control element having a proximal end region and a distal end region;

a distal luminal portion coupled to the distal end region of the control element, the distal luminal portion having a side wall defining an inner lumen;

the side wall comprising;

a tubular inner liner having an outer surface coated with a compound suitable for bonding;

a reinforcement structure that is a helical coil bonded to the coated outer surface of the tubular inner liner; and

an outer jacket surrounding the helical coil.

29. A neurovascular catheter extension segment as in claim 28, wherein the outer jacket is formed from a plurality of tubular segments positioned coaxially about the helical coil.

30. A neurovascular catheter extension segment as in claim 29, wherein a proximal one of the plurality of tubular segments has a durometer of at least about 60D and a distal one of the plurality of tubular segments has a durometer of no more than about 35D.

31. A neurovascular catheter extension segment as in claim 28, wherein the tubular liner comprises polytetrafluoroethylene.

32. A neurovascular catheter extension segment as in claim 28, wherein the helical coil comprises a shape memory material.

33. A neurovascular catheter extension segment as in claim 32, wherein the helical coil comprises Nitinol.

34. A neurovascular catheter extension segment as in claim 29, wherein the outer jacket is formed from at least five discrete tubular segments.

35. A neurovascular catheter extension segment as in claim 29, wherein the outer jacket is formed from more than five discrete tubular segments.

36. A neurovascular catheter extension segment as in claim 35, wherein a difference in durometer between a proximal one of the tubular segments and a distal one of the tubular segments is at least about 20D.

37. A neurovascular catheter extension segment as in claim 36, wherein the difference is at least about 30D.

38. A neurovascular catheter extension segment as in claim 28, wherein the control element comprises a hypotube having a central lumen.

39. A neurovascular catheter extension segment as in claim 38, wherein the distal luminal portion has an outer diameter that is between 0.040″

and 0.100″ and

wherein the control element has an outer diameter that is between 0.014″ and

0.026″

.