Adjustable stiffness catheter

Patent metadata

Field	Value
Publication number	US-2016136393-A1
Application number	US-201514828965-A
Country	US
Kind code	A1
Filing date	Aug 18, 2015
Priority date	Feb 19, 2013
Publication date	May 19, 2016
Grant date	—

Abstract

The present invention relates to a catheter that has adjustable stiffness that enables a user to select the stiffness of at least one region of the catheter during insertion and navigation through a body lumen. A preferred embodiment of the invention works in combination with a guidewire to enable placement of the catheter at a position within the vascular system, for example, to enable treatment of a variety of medical conditions. The catheter can include segments that undergo relative movement in response to actuation by the user to adjust the flexibility of the at least one region, preferably located at or near the distal end of the catheter.

First claim

1 . An adjustable catheter comprising:
an inner tube having a first plurality of spaced regions having a first stiffness separated by a first plurality of spaced segments having a greater stiffness than the plurality of spaced regions; an outer tube extending around the inner tube such that the outer tube and the inner tube undergo relative longitudinal translation, the outer tube having a second plurality of spaced regions having a second stiffness separated by a second plurality of spaced segments having a greater stiffness than the second plurality of spaced regions; and an actuator configured to provide relative longitudinal motion of the inner tube and the outer tube.

2 . The catheter of claim 1 , wherein the first plurality of spaced segments comprise tubular elements.

3 . The catheter of claim 1 , further comprising a third tube positioned between the inner tube and the outer tube.

4 . The catheter of claim 3 , wherein the third tube comprises a flexible region having alternating segments of higher and lower stiffness.

5 . The catheter of claim 1 , further comprising a handle mounted at a proximal end of the catheter, the handle including a portion of the actuator and a directional control element that moves the catheter tip.

6 . The catheter of claim 5 , wherein the handle comprises at least one fluid supply port and a directional control wire.

7 . The catheter of claim 5 , wherein the handle comprises two fluid supply ports.

8 . The catheter of claim 1 , wherein the actuator comprises a cam and cam follower operably attached to one of the inner layer and outer layer.

9 . The catheter of claim 1 , further comprising at least one lumen extending through the catheter.

10 . The catheter of claim 9 , further comprising a fluid source coupled to the lumen for delivering a fluid though the lumen.

11 . The catheter of claim 1 , further comprising a guidewire positioned within a lumen within the inner tube.

12 . The catheter of claim 1 , wherein the first plurality of spaced regions and second plurality of spaced regions each comprise polymeric materials.

13 . The catheter of claim 1 , further comprising a lubricious coating disposed on the surface of at least one of the inner tube and the outer tube.

14 . The catheter of claim 13 , comprising a lubricious coating disposed on an outer surface of the inner tube.

15 . The catheter of claim 13 , comprising a lubricious coating disposed on an outer surface of the inner tube and a lubricious coating disposed on an outer surface of the outer tube.

16 . The catheter of claim 13 , wherein the coating comprises polytetrafluoroethylene.

17 . The catheter of claim 13 , wherein the coating comprises a hydrophilic polymer.

18 . The catheter of claim 1 , wherein the first plurality of spaced regions are disposed at a distal end of the catheter such that the distal end has a minimum radius of curvature in a range of 2-6 mm, or preferably 3-5 mm.

19 . The catheter of claim 1 , wherein the second plurality of spaced regions are disposed at a distal end of the catheter.

20 . The catheter of claim 1 , further comprising at least one radiopaque marker.

21 . The catheter of claim 1 , wherein the actuator is operably coupled to the inner tube to move the inner tube longitudinally within the outer tube.

22 . The catheter of claim 1 , further comprising a treatment device for delivery to a treatment site.

23 . The catheter of claim 1 , further comprising a medicament delivery channel.

24 . A method for guiding a catheter to a treatment site within a body comprising:
inserting a catheter into a body lumen, the catheter having a flexible distal region including a plurality of movable segments; actuating relative movement between the plurality of movable segments to alter a stiffness of the flexible distal region; and advancing the catheter within the body lumen.

25 . The method of claim 24 , wherein the actuating step comprises sliding at least one layer within the catheter to alter the stiffness.

26 . The method of claim 24 , further comprising advancing a guidewire through a central lumen of the catheter to select a lumen branch to advance the catheter to a treatment site.

27 . The method of claim 24 , wherein the actuating step comprises actuating relative movement of a first layer and a second layer, the first layer comprising alternating first regions of differing stiffnesses, and the second layer comprising alternating second regions of the differing stiffnesses.

28 . The method of claim 24 , further comprising delivering a fluid to a site within the body.

29 . The method of claim 24 , further comprising delivering a treatment device to a treatment device.

30 . The method of claim 29 , wherein the step of delivering a treatment device comprises inserting at least one of a coil, a snare, a balloon, or a stent to a treatment site.

31 . The method of claim 24 , further comprising grasping a handle to move the catheter, the handle including an actuator to adjust a flexibility of the catheter.

32 . The method of claim 24 , further comprising percutaneously introducing the catheter into a body lumen wherein the catheter comprises:
an inner tube having a first plurality of spaced regions having a first stiffness separated by a first plurality of spaced segments having a greater stiffness than the plurality of spaced regions; and an outer tube extending around the inner tube such that the outer tube and the inner tube undergo relative longitudinal translation, the outer tube having a second plurality of spaced regions having a second stiffness separated by a second plurality of spaced segments having a greater stiffness than the second plurality of spaced regions.

33 . The method of claim 24 , wherein the first plurality of spaced segments comprise tubular elements.

34 . The method of claim 24 , further comprising positioning a third tube between the inner tube and the outer tube.

35 . The method of claim 24 , wherein the third tube comprises a flexible region having alternating segments of higher and lower stiffness.

36 . The method of claim 24 , further comprising inserting a fluid with the handle that comprises at least one fluid supply port.

37 . A method of manufacturing a catheter, comprising,
forming an inner tube having a first plurality of spaced regions having a first stiffness separated by a first plurality of spaced segments having a greater stiffness than the plurality of spaced regions; and forming an outer tube extending around the inner tube such that the outer tube and the inner tube undergo relative longitudinal translation, the outer tube having a second plurality of spaced regions having a second stiffness separated by a second plurality of spaced segments having a greater stiffness than the second plurality of spaced regions.

38 . The method of claim 37 , wherein the first plurality of spaced segments comprise tubular elements.

39 . The method of claim 37 , wherein the first plurality of spaced regions and second plurality of spaced regions each comprise polymeric materials.

40 . The method of claim 37

Assignees

• Beth Israel Hospital
• Beth Israel Deacones Medical Ct Inc

Inventors

• Tsai Leo Lee
• Chen Yuyin
• Ramanan Vyas

Classifications

• A61B1/005 Primary

  Flexible endoscopes · CPC title

• A61M25/0054

  with regions for increasing flexibility · CPC title

• A61M2025/0004

  having two or more concentrically arranged tubes for forming a concentric catheter system · CPC title

• A61M25/0108

  using radio-opaque or ultrasound markers · CPC title

• A61M25/09

  Guide wires · CPC title