Basket-shaped catheter with improved distal hub

• US 9,974,460 B2
• Filed: 05/06/2016
• Issued: 05/22/2018
• Est. Priority Date: 05/06/2016
• Status: Active Grant

• Current Assignee: Biosense Webster Israel Ltd. (Johnson & Johnson)
• Original Assignee: Biosense Webster Israel Ltd. (Johnson & Johnson)
• Inventors: Wu, Steven, Min, Sungwoo, Aujla, Vishav, Merchant, Neil, Basu, Shubhayu, Williams, Stuart, Hoitink, Ryan
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US15/148,154
• Publication Number:
  US 20170319140A1
• Time in Patent Office: 746 Days
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/187 Strain relief means
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: Y10T 29/49222 forming array of contacts or terminals

Abstract

This disclosure is directed to a catheter having a basket-shaped electrode assembly with a high electrode density. The basket-shaped electrode assembly may have a plurality of spines, such as up to twelve, each with a plurality of electrodes, such as up to sixteen. The distal ends of the plurality of spines are joined at a distal hub, all of which are fashioned from a single piece of superelastic material.

Claims

1. A catheter comprising:

an elongated catheter body extending along a longitudinal axis, the elongated catheter body having a proximal end and a distal end;

a flexible wire assembly positioned at the distal end of the elongated catheter body formed from a single piece of shape memory material, the flexible wire assembly having a plurality of flexible wires, each flexible wire having a proximal end and a distal end, the flexible wire assembly further having a distal hub extending from the distal ends of at least a portion of the plurality of flexible wires, the distal hub configured to be generally parallel to the longitudinal axis of the elongated catheter body when the catheter is in a first operational state and generally perpendicular to the longitudinal axis of the elongated catheter body when the catheter is in a second operational state;

a plurality of spines formed from the plurality of flexible wires; and

a plurality of electrodes and cabling attached to each spine, the plurality of electrodes and cabling having a corresponding plurality of wires coiled on a core and covered by a sheath such that each electrode is attached through the sheath to one of the plurality of wires, such that spines bow radially outwardly in the second operational state and are arranged generally along the longitudinal axis of the catheter body in the first operational state.

2. The catheter of claim 1, wherein the distal hub further comprises a stress-relieving edge.

3. The catheter of claim 2, wherein at least a portion of the shape memory material of the stress-relieving edge comprises a first thickness at a distal end and tapering to a second thickness at the distal end of the flexible wire.

4. The catheter of claim 2, wherein the stress-relieving edge further includes a radius of curvature, the radius of curvature directed toward an inner diameter of the distal hub.

5. The catheter of claim 1, wherein each of the plurality of flexible wires further comprises a bridge portion, the bridge portion connecting the distal end of the flexible wires to the distal hub.

6. The catheter of claim 1, wherein the distal ends of two adjacent flexible wires form a bridge portion, the bridge portion connecting the flexible wires to the distal hub.

7. The catheter of claim 6, wherein the bridge portion comprises a sinusoid shape.

8. The catheter of claim 6, wherein the bridge portion comprises a linear shape.

9. The catheter of claim 1, wherein the distal hub comprises a waveform, the wave form further comprising a plurality of U-shaped indentations, wherein each U-shaped indentation is placed between adjacent flexible wires.

10. The catheter of claim 9, wherein the U-shaped indentations define a gap, the gap having a first distance when in a delivery configuration and a second distance when in a deployed configuration.

11. The catheter of claim 1, wherein the distal hub comprises a waveform, the wave form further comprising a plurality of sinusoidal-shaped indentations, wherein each sinusoidal-shaped indentation is placed between adjacent flexible wires.

12. The catheter of claim 11, wherein the sinusoidal-shaped indentations define a gap, the gap having a first distance when in a delivery configuration and a second distance when in a deployed configuration.

13. The catheter of claim 1, wherein the distal hub comprises a continuous ribbon shaped waveform, the wave form further comprising a plurality of distal indentations, wherein each distal indentation is placed between adjacent flexible wires and extends distally from the distal ends of the flexible wires.

14. The catheter of claim 13, wherein the distal hub has a plurality of distal indentations that are distally oriented and a plurality of proximal indentations that are proximally oriented, wherein the distal indentations and proximal indentations alternate and are evenly spaced around a circumference of the distal hub.

15. The catheter of claim 1, wherein the distal hub has a first stress relieving edge and a second stress relieving edge, wherein the first stress relieving edge has a waveform shape on a distal end of the distal hub, and the second stress relieving edge has an arched shape on a proximal edge of the distal hub, the distal hub further comprising at least two distal projections, wherein the distal projections are evenly distributed around a circumference of the distal hub.

16. A catheter comprising:

an elongated catheter body extending along a longitudinal axis, the elongated catheter body having a proximal end and a distal end;

a flexible wire assembly positioned at the distal end of the elongated catheter body formed from a single piece of shape memory material, the flexible wire assembly having a plurality of flexible wires, each flexible wire having a proximal end and a distal end, the flexible wire assembly further having a distal hub extending from the distal ends of at least a portion of the plurality of flexible wires, the distal hub configured to be generally parallel to the longitudinal axis of the elongated catheter body when the catheter is in a first operational state and generally perpendicular to the longitudinal axis of the elongated catheter body when the catheter is in a second operational state, wherein the distal hub further comprises a stress-relieving edge and wherein the stress relieving edge has a first diameter in the first operational state and a second diameter in the second operational state, the first diameter being greater than the second diameter;

a plurality of spines formed from the plurality of flexible wires; and

a plurality of electrodes and cabling attached to each spine, the plurality of electrodes and cabling having a corresponding plurality of wires coiled on a core and covered by a sheath such that each electrode is attached through the sheath to one of the plurality of wires, such that spines bow radially outwardly in the second operational state and are arranged generally along the longitudinal axis of the catheter body in the first operational state.