CATHETERS WITH ENHANCED FLEXIBILITY AND ASSOCIATED DEVICES, SYSTEMS, AND METHODS

• US 20140114287A1
• Filed: 10/22/2013
• Published: 04/24/2014
• Est. Priority Date: 10/22/2012
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Beasley, Rudy, Goshgarian, Justin, Ku, Vincent
• Granted Patent: US 9,044,575 B2
• Time in Patent Office: Days
• US Class Current: 604/525
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 : for high-frequency therapy
• CPC Class Codes: A61N 2007/0021 : Neural system treatment
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Claims

1. A neuromodulation catheter, comprising:

an elongate shaft including—

two or more first cut shapes, the first cut shapes being configured to at least partially resist deformation in response to compression on the shaft along a longitudinal axis of the shaft, tension on the shaft along the longitudinal axis, and torsion on the shaft in a first circumferential direction perpendicular to the longitudinal axis, and

two or more second cut shapes, the second cut shapes being configured to at least partially resist deformation in response to compression on the shaft along the longitudinal axis, torsion on the shaft in the first circumferential direction, and torsion on the shaft in a second circumferential direction opposite to the first circumferential direction; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft,

wherein—

the first and second cut shapes are interspersed along a helical path extending about the longitudinal axis,

the first cut shapes are less resistant to deformation in response to torsion on the shaft in the second circumferential direction than are the second cut shapes, and

the second cut shapes are less resistant to deformation in response to tension on the shaft along the longitudinal axis than are the first cut shapes.

2. The neuromodulation catheter of claim 1 wherein:

the shaft includes a hypotube having a wall thickness; and

the first and second cut shapes extend at least partially through the wall thickness of the hypotube.

3. The neuromodulation catheter of claim 1 wherein the first and second cut shapes alternate along the helical path in a pattern.

4. The neuromodulation catheter of claim 1 wherein the first and second cut shapes are portions of a continuous cut.

5. The neuromodulation catheter of claim 1 wherein:

the first cut shapes are sinusoidal and have amplitudes with a first orientation relative to the longitudinal axis; and

the second cut shapes are sinusoidal and have amplitudes with a second orientation relative to the longitudinal axis, the second orientation being different than the first orientation.

6. The neuromodulation catheter of claim 1 wherein an axial density of the first and second cut shapes along the longitudinal axis is selected to facilitate intravascular delivery of the neuromodulation element to a treatment location within or otherwise proximate to a renal artery of a human patient via a transradial approach.

7. The neuromodulation catheter of claim 1 wherein:

the helical path extends along a portion of the longitudinal axis corresponding to a segment of the shaft; and

a distance along the longitudinal axis between the neuromodulation element and the segment is selected to cause the segment to be at least proximate to a relatively sharply angled or otherwise relatively tortuous region of a transradial approach when the neuromodulation element is operably positioned at a treatment location within or otherwise proximate to a renal artery of a human patient.

8. The neuromodulation catheter of claim 7 wherein the relatively sharply angled or otherwise relatively tortuous region is within or otherwise proximate to a subclavian artery of a human patient.

9. The neuromodulation catheter of claim 1 wherein:

the shaft includes an uncut region; and

the first and second cut shapes are positioned along portions of the helical path on either side of the uncut region.

10. The neuromodulation catheter of claim 9 wherein the shaft includes a guide wire exit opening at the uncut region.

11. The neuromodulation catheter of claim 1 wherein:

the individual first cut shapes include a first peak and a second peak with a first interface therebetween;

the individual second cut shapes include a third peak and a fourth peak with a second interface therebetween; and

an angle between the first interface and the longitudinal axis is greater than an angle between the second interface and the longitudinal axis.

12. The neuromodulation catheter of claim 11 wherein the shaft includes a guide wire exit opening in place of the first peak, the second peak, the third peak, the fourth peak, or a combination thereof.

13. The neuromodulation catheter of claim 11 wherein:

the first interface is perpendicular to the longitudinal axis; and

the second interface is parallel to the longitudinal axis.

14. The neuromodulation catheter of claim 11 wherein:

the shaft includes a first segment and a second segment;

the helical path has a first portion extending around a first portion of the longitudinal axis corresponding to the first segment;

the helical path has a second portion extending around a second portion of the longitudinal axis corresponding to the second segment; and

an axial density of the first and second cut shapes is greater along the first portion of the longitudinal axis than along the second portion of the longitudinal axis.

15. The neuromodulation catheter of claim 14 wherein:

the shaft further includes a third segment between the first and second segments;

the helical path has a third portion extending around a third portion of the longitudinal axis corresponding to the third segment; and

the axial density of the first and second cut shapes increases along the third portion of the longitudinal axis from the second segment toward the first segment.

16. The neuromodulation catheter of claim 14 wherein an average length of the second interface is greater along the second portion of the longitudinal axis than along the first portion of the longitudinal axis.

17. A neuromodulation catheter, comprising:

an elongate shaft extending along a longitudinal axis, the shaft including—

two or more sinusoidal first cut shapes having amplitudes with a first orientation relative to the longitudinal axis, and

two or more sinusoidal second cut shapes having amplitudes with a second orientation relative to the longitudinal axis, the second orientation being different than the first orientation; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft,

wherein the first and second cut shapes are interspersed along a helical path extending about the longitudinal axis.

18. The neuromodulation catheter of claim 17 wherein the orientation of the first cut shapes is perpendicular to the orientation of the second cut shapes.

19. A neuromodulation catheter, comprising:

an elongate shaft including two or more cut shapes configured to at least partially resist deformation in response to compression on the shaft along a longitudinal axis of the shaft, tension on the shaft along the longitudinal axis, torsion on the shaft in a first circumferential direction perpendicular to the longitudinal axis, and torsion on the shaft in a second circumferential direction opposite to the first circumferential direction, the cut shapes being distributed along a helical path extending about the longitudinal axis; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft.

20. The neuromodulation catheter of claim 19 wherein the shaft includes tabs adjacent to the cut shapes, the individual tabs including a flared portion and a restricted portion.

21. The neuromodulation catheter of claim 20 wherein:

the flared portion includes a rounded head; and

the restricted portion includes a rounded neck.

22. The neuromodulation catheter of claim 20 wherein:

the flared portion comprises a wedge-shaped head; and

the restricted portion comprises a rounded neck,

and wherein the individual tabs and corresponding cut shapes comprise interlocking, wedge-shaped components.

23. A neuromodulation catheter, comprising:

an elongate shaft including two or more sinusoidal cut shapes; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft,

wherein—

the cut shapes are distributed along a helical path extending around a longitudinal axis of the shaft; and

the cut shapes have an orientation that is perpendicular to the helical path.

24. The neuromodulation catheter of claim 23 wherein:

the individual cut shapes include a first peak and a second peak with an interface therebetween; and

the interface is perpendicular to the helical path.

25. A neuromodulation catheter, comprising:

an elongate shaft including—

a first helically wound elongate member having a series of first windings with a first average helix angle, the first windings at least partially forming a first tubular structure; and

a second helically wound elongate member having a series of second windings with a second average helix angle, the second windings at least partially forming a second tubular structure; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft,

wherein—

the first tubular structure is disposed within the second tubular structure,

the first and second tubular structures are concentric, and

the first average helix angle is different than the second average helix angle by an angle within a range from about 10 degrees to about 140 degrees.

26. The neuromodulation catheter of claim 25 wherein a difference between the first and second average helix angles changes at least once along a length of the shaft.

27. The neuromodulation catheter of claim 25 wherein a difference between the first and second average helix angles decreases distally along the length of the shaft.

28. The neuromodulation catheter of claim 25 wherein the shaft includes a biocompatible jacket at least partially encasing the first and second tubular structures.

29. The neuromodulation catheter of claim 25 wherein:

the first tubular structure includes a transition region; and

the first windings on either side of the transition region having different average helix angles.

30. The neuromodulation catheter of claim 25 wherein:

the second tubular structure includes a transition region; and

the second windings on either side of the transition region have different average helix angles.

31. The neuromodulation catheter of claim 25 wherein at least one of the first and second helically wound elongate members is multifilar.

32. The neuromodulation catheter of claim 25 wherein the first and second helically wound elongate members are multifilar.

33. The neuromodulation catheter of claim 25 wherein an axial density of the first windings, the second windings, or both along a longitudinal axis of the shaft is selected to facilitate intravascular delivery of the neuromodulation element to a treatment location within or otherwise proximate to a renal artery of a human patient via a transradial approach.

34. The neuromodulation catheter of claim 25 wherein:

the first and second tubular structures extend along a portion of a longitudinal axis of the shaft, the portion of the longitudinal axis corresponding to a segment of the shaft; and

a distance along the longitudinal axis between the neuromodulation element and the segment is selected to cause the segment to be at least proximate to a relatively sharply angled or otherwise relatively tortuous region of a transradial approach when the neuromodulation element is operably positioned at a treatment location within or otherwise proximate to a renal artery of a human patient.

35. The neuromodulation catheter of claim 34 wherein the relatively sharply angled or otherwise relatively tortuous region is within or otherwise proximate to a subclavian artery.

36. A neuromodulation catheter, comprising:

an elongate shaft including—

a first segment made at least partially of a first shape-memory alloy having a first shape-memory transformation temperature range, and

a second segment made at least partially of a second shape-memory alloy having a second shape-memory transformation temperature range lower than the first shape-memory transformation temperature range, the second segment being proximal to the first segment along a longitudinal axis of the shaft; and

a neuromodulation element operably connected to the shaft via a distal end portion of the shaft.

37. The neuromodulation catheter of claim 36 wherein:

the elongate shaft includes a third segment made at least partially of a third shape-memory alloy, the third segment being between the first and second segments along the longitudinal axis;

the first, second, and third shape-memory alloys are the same; and

a shape-memory transformation temperature range of the third shape-memory alloy gradually increases along the third segment from the second segment toward the first segment.

38. The neuromodulation catheter of claim 37 wherein the first, second, and third shape-memory alloys are nitinol.

39. The neuromodulation catheter of claim 38 wherein:

the first shape-memory transformation temperature range includes an Af temperature greater than body temperature; and

the second shape-memory transformation temperature range includes an Af temperature less than body temperature.