Devices and methods for manipulating a catheter shaft

• US 8,414,604 B2
• Filed: 10/13/2009
• Issued: 04/09/2013
• Est. Priority Date: 10/13/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Doud, Darren, Huljev, Tomislav, McNall, Ralph, Fell, Brandon, Gupta, Priyanshu, Olivera, Ryan, Pham, Thomas C.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Papeika, Rachel S
• Application Number:
  US12/578,204
• Publication Number:
  US 20100130996A1
• Time in Patent Office: 1,274 Days
• Field of Search: 606/159, 606205-209, 606/167, 606/170, 606/174, 606/180, 606/144, 606/148, 606/151, 600/585, 600/139, 600141-142, 600/146, 600170-173, 600106-107, 604523-525, 604/528, 604/532, 604/95.04, 604/95.05, 604158-172, 604/170.03
• US Class Current: 606/159
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00389 Button or wheel for performing multiple functions, e.g. rotation of shaft and end effector
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/320791 with cutter extending outside the cutting window
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014

Abstract

A catheter for performing a procedure at a treatment site in the lumen of a blood vessel. The catheter includes an elongate tubular shaft having a proximal bend, a distal bend and a hinge element. A distal portion of the shaft includes a window extending through the sidewall of the shaft between the hinge element and the distal end of the elongate tubular shaft. A working element is disposed within the lumen of the elongate tubular shaft and is configured for performing the procedure through the window at the treatment site. The bends and hinge element are configured to urge the window against a wall of the vessel at the treatment site.

Claims

1. A catheter for performing a procedure at a treatment site in the lumen of a blood vessel, the blood vessel having a diameter D at the treatment site, the catheter comprising:

an elongate tubular shaft having distal and proximal ends and a sidewall defining a lumen, the elongate tubular shaft having a proximal bend, a distal bend and a hinge element, the proximal bend defining a first undeflected angle prior to insertion of the elongate tubular shaft into the lumen of the blood vessel and a first deflected angle greater than the first undeflected angle when the elongate tubular shaft is contained within the lumen of the blood vessel, the distal bend defining a second undeflected angle greater than the first undeflected angle prior to insertion of the elongate tubular shaft into the lumen of the blood vessel and a second deflected angle greater than the second undeflected angle when the elongate tubular shaft is contained within the lumen of the blood vessel, the hinge element being spaced proximally of the distal end of the elongate tubular shaft and distally of the distal bend, the distal bend being positioned between the proximal bend and the hinge element, a distal portion of the elongate tubular shaft extending between the hinge element and the distal end of the elongate tubular shaft and a mid portion of the elongate tubular shaft extending between the hinge element and the proximal bend, the distal portion including a window extending through the sidewall between the hinge element and the distal end of the elongate tubular shaft; and

a working element disposed within the lumen of the elongate tubular shaft, the working element configured for performing the procedure through the window at the treatment site, the first and second undeflected angles being selected to form a maximum excursion of the elongate tubular shaft between the proximal bend and the hinge element greater than diameter D such that the window is urged against a wall of the vessel at the treatment site.

2. The catheter of claim 1 wherein the proximal and distal bends are configured to lie within a first plane and the hinge element is configured to permit bending of the distal portion with respect to the mid portion only in the first plane.

3. The catheter of claim 1 wherein the first and second undeflected angles are selected to urge the window against the wall of the vessel at a force in the range of 0.05 to 0.5 pounds.

4. The catheter of claim 1 wherein the first undeflected angle is in the range of 90°

to 150° and

the second undeflected angle is in the range of 100°

to 180°

.

5. The catheter of claim 1 wherein a length from the proximal bend to the distal bend is greater that a length from the distal bend to the hinged element.

6. The catheter of claim 1 wherein a length between the proximal and distal bends is in the range of 0.5 to 2.0 inches.

7. The catheter of claim 1 wherein a length between the distal bend and the hinge element is in the range of 0.375 to 0.625 inches.

8. The catheter of claim 1 wherein the maximum excursion is in the range of 3 to 40 mm.

9. The catheter of claim 1 further comprising a shaft manipulation member having a body defining a lumen sized to accept the elongate tubular shaft, the manipulation member further having opposed shaft engaging elements within the body which are moveable between a locked position in which the shaft engaging elements engage the elongate tubular shaft to lock the body on the elongate tubular shaft and an unlocked position in which the body is free to rotate and axially translate over the elongate tubular shaft.

10. The catheter of claim 9 wherein the shaft engaging elements are biased in the unlocked position.

11. The catheter of claim 1 wherein the working element is an atherectomy cutting device.

12. A catheter for performing a procedure at a treatment site in the lumen of a blood vessel comprising:

an elongate tubular shaft having distal and proximal ends and a sidewall defining a lumen, the elongate tubular shaft having a curved distal portion with a continuously decreasing radius of curvature, the continuously decreasing radius of curvature being oriented in a first plane from a proximal end of the distal portion to the distal end of the elongate tubular shaft, the distal portion including a hinge element spaced proximally of the distal end of the elongate tubular shaft, the hinge element dividing the distal portion into a distal segment between the hinge element and the distal end of the elongate tubular shaft and a proximal segment between the hinge element and the proximal end of the distal portion, the hinge element being configured to permit the distal segment to bend with respect to the proximal segment only in the first plane, the distal segment including a window extending through the sidewall between the hinge element and the distal end of the elongate tubular shaft; and

a working element disposed within the lumen of the elongate tubular shaft, the working element configured for performing the procedure through the window at the treatment site, the continuously decreasing radius of curvature being selected to urge the window against a wall of the vessel at the treatment site during use.

13. The catheter of claim 12 wherein the curved distal portion forms a continuous curve in the range of 90°

to 720°

.

14. The catheter of claim 12 wherein a maximum curve diameter of the curved distal portion is in the range of 3 mm to 50 mm.

15. The catheter of claim 12 further comprising a shaft manipulation member having a body defining a lumen sized to accept the elongate tubular shaft, the shaft manipulation member further having opposed shaft engaging elements moveable between a locked position in which the shaft engaging elements engage the elongate tubular shaft to lock the body on the elongate tubular shaft and an unlocked position in which the body is free to rotate and axially translate over the elongate tubular shaft.

16. The catheter of claim 15 wherein the shaft engaging elements are biased in the unlocked position.

17. The catheter of claim 12 wherein the working element is an atherectomy cutting device.

18. A method of performing a procedure at a treatment site in the lumen of a blood vessel comprising:

providing an elongate tubular shaft having distal and proximal ends and a sidewall defining a lumen, the elongate tubular shaft having a curved distal portion with a continuously decreasing radius of curvature, the continuously decreasing radius of curvature being oriented in a first direction from a proximal end of the distal portion to the distal end of the elongate tubular shaft, the distal portion including a hinge element spaced proximally of the distal end of the elongate tubular shaft, the hinge element dividing the distal portion into a distal segment between the hinge element and the distal end of the elongate tubular shaft and a proximal segment between the hinge element and the proximal end of the distal portion, the hinge element being configured to permit the distal segment to bend with respect to the proximal segment only in the first direction and a second direction opposite the first direction, the distal segment including a window extending through the sidewall between the hinge element and the distal end of the elongate tubular shaft;

advancing the elongate tubular shaft through the lumen of the vessel to the treatment site;

orienting the elongate tubular shaft in a position where the continuously decreasing radius of curvature of the curved distal portion causes the distal segment to bend with respect to the proximal segment at the hinge element in the second direction to urge the window against a wall of the vessel in a desired location at the treatment site; and

performing a procedure through the window at the treatment site with a working element disposed within the lumen of the elongate tubular shaft while the window is urged against the wall of the vessel.

19. The method of claim 18 wherein the curved distal portion forms a continuous curve in the range of about 90°

to 720°

.

20. The method of claim 18 wherein a maximum curve diameter of the curved distal portion is in the range of about 3 mm to 50 mm.

21. A catheter for accessing a site on the wall of a blood vessel comprising:

an elongate tubular shaft having distal and proximal ends and a sidewall defining a lumen, the elongate tubular shaft having a first bend, a second bend spaced a predetermined distance distally of the first bend and a window extending through the sidewall, the window being positioned distally of the second bend and proximally of the distal end of the elongate tubular member, the first bend defining a first preformed angle, the second bend defining a second preformed angle greater than the first preformed angle, the shaft being sized such that during use in the blood vessel the first bend is deflected to define a first deflected angle greater than the first preformed angle and the second bend is deflected to define a second deflected angle greater than the second preformed angle, the first and second preformed angles and the predetermined distance being selected to urge the window against the site on the wall of the blood vessel during use.

22. The catheter of claim 21 wherein the elongate tubular shaft further includes a hinge element spaced proximally of the window and distally of the second bend.

23. The catheter of claim 22 wherein the elongate tubular shaft includes a distal portion between the hinge element and the distal end of the elongate tubular shaft and wherein the hinge element is configured as a pivot point about which the distal portion bends.

24. The catheter of claim 23 wherein the distal portion has a longitudinal axis and wherein the hinge element is configured such that when the window is urged against the site on the wall of the blood vessel during use the distal portion is positioned such that the longitudinal axis of the distal portion is substantially parallel to a longitudinal axis of the blood vessel.

25. The catheter of claim 22 wherein the first and second bends are configured to lie within a first plane and the hinge element is configured to permit bending of the elongate tubular member distal of the hinge element only in the first plane.

26. The catheter of claim 22 wherein a length from the first bend to the second bend is greater that a length from the second bend to the hinged element.

27. The catheter of claim 22 wherein a length between the second bend and the hinge element is in the range of 0.375 to 0.625 inches.

28. The catheter of claim 21 further comprising a working element disposed within the lumen of the elongate tubular shaft, the working element configured for performing a procedure through the window at the site on the wall of the blood vessel.

29. The catheter of claim 28 wherein the working element is an atherectomy cutting device.

30. The catheter of claim 21 wherein the first and second preformed angles are selected to urge the window against the wall of the vessel at a force in the range of 0.05 to 0.5 pounds.

31. The catheter of claim 21 wherein the first angle is in the range of 90°

to 150° and

the second angle is in the range of 100°

to 180°

.

32. The catheter of claim 21 wherein a length between the first and second bends is in the range of 0.5 to 2.0 inches.

33. A catheter for performing a procedure at a treatment site in the lumen of a blood vessel comprising:

an elongate tubular shaft having distal and proximal ends and a sidewall defining a lumen, the elongate tubular shaft having a proximal bend, a distal bend and a hinge element, the elongate tubular shaft being configured such that when unconstrained the proximal bend defines a first angle and the distal bend defines a second angle greater than the first angle, the elongate tubular shaft being further configured such that when constrained within the lumen of the blood vessel the proximal bend is deflected to define a first deflected angle greater than the first angle and the distal bend is deflected to define a second deflected angle greater than the second angle, the hinge element being spaced proximally of the distal end of the elongate tubular shaft and distally of the distal bend, the distal bend being positioned between the proximal bend and the hinge element, a distal portion of the elongate tubular shaft extending between the hinge element and the distal end of the elongate tubular shaft and a mid portion of the elongate tubular shaft extending between the hinge element and the proximal bend, the distal portion including a window extending through the sidewall between the hinge element and the distal end of the elongate tubular shaft, the proximal bend, distal bend and hinge element being configured to urge the window against a wall of the vessel at the treatment site.

34. The catheter of claim 33 further comprising a working element disposed within the lumen of the elongate tubular shaft, the working element configured for performing the procedure through the window at the treatment site when the window is urged against the wall of the blood vessel during use.

35. The catheter of claim 34 wherein the working element is an atherectomy cutting device.

36. The catheter of claim 33 wherein the proximal and distal bends are configured to lie within a first plane and the hinge element is configured to permit bending of the distal portion with respect to the mid portion only in the first plane.

37. The catheter of claim 33 wherein the first and second angles are selected to urge the window against the wall of the vessel at a force in the range of 0.05 to 0.5 pounds.

38. The catheter of claim 33 wherein the first angle is in the range of 90°

to 150° and

the second angle is in the range of 100°

to 180°

.

39. The catheter of claim 33 wherein a length from the proximal bend to the distal bend is greater that a length from the distal bend to the hinged element.

40. The catheter of claim 33 wherein a length between the proximal and distal bends is in the range of 0.5 to 2.0 inches.

41. The catheter of claim 33 wherein a length between the distal bend and the hinge element is in the range of 0.375 to 0.625 inches.