SHAPE IMPARTING MECHANISM INSERTION

• US 20100030112A1
• Filed: 05/04/2007
• Published: 02/04/2010
• Est. Priority Date: 05/08/2006
• Status: Active Grant

• Current Assignee: Cathrx Ltd
• Original Assignee: Cathrx Ltd
• Inventors: Partlett, Matthew, Anderson, Neil L.
• Granted Patent: US 8,977,333 B2
• Time in Patent Office: Days
• US Class Current: 600/585
• 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 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6856 with a distal loop
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: B29C 53/083 bending longitudinally, i.e. modifying the curvature of the tube axis

Abstract

A shape imparting mechanism (10) for a catheter includes an elongate element (12) dimensioned to fit within a lumen of an electrode sheath 14 of a catheter. An insertion facilitating arrangement (22) is carried at a distal end of the elongate element (12) for facilitating insertion of the distal end of the elongate element (12) into the lumen of the electrode sheath (14) of the catheter.

Claims

1. :

A shape imparting mechanism for a catheter, the shape imparting mechanism including;

an elongate element dimensioned to fit within a lumen of an electrode sheath of a catheter; and

an insertion facilitating arrangement carried at a distal end of the elongate element for facilitating insertion of the distal end of the elongate element into the lumen of the electrode sheath of the catheter.

2. :

The mechanism of claim 1 in which a tip of the elongate element is rounded to aid insertion into the lumen of the electrode sheath of the catheter.

3. :

The mechanism of claim 2 in which a distal part of the elongate element has an irregularly-shaped configuration.

4. :

The mechanism of claim 3 in which the insertion facilitating arrangement includes a sleeve axially displaceable relative to the elongate element, the sleeve being displaceable between a first, extended position in which the sleeve collapses the irregularly-shaped distal part of the elongate element into a substantially rectilinear configuration to facilitate insertion of the distal end of the elongate element into the lumen of the electrode sheath and a second, retracted position in which the distal part of the elongate element adopts the irregularly-shaped configuration.

5. :

The mechanism of claim 4 in which the elongate element includes a withdrawal inhibiting means at its distal end to inhibit withdrawal of the distal end into the sleeve.

6. :

The mechanism of claim 4 in which at least the distal part of the elongate element is of a shape memory material which allows the distal part to adopt its irregularly shaped configuration when the sleeve is in its second, retracted position.

7. :

The mechanism of claim 4 in which the elongate element has a bend-enhancing portion arranged proximally of the irregularly shaped distal part, the sleeve, at least when in its first position, exposing the bend-enhancing portion to facilitate steering of the irregularly shaped distal part of the elongate element, in use.

8. :

The mechanism of claim 2 in which the insertion facilitating arrangement comprises a kink imparted to a distal part of the elongate element, proximally of the rounded tip of the elongate element.

9. :

The mechanism of claim 8 in which the kink is arranged distally of the irregularly shaped configuration of the elongate element, the kink defining an angled distal portion which is arranged at a predetermined, acute angle relative to an axis of that part of the elongate element arranged proximally of the kink.

10. :

A catheter assembly which includes;

a handle having a proximal end and a distal end;

a shape imparting mechanism, as claimed in claim 4, extending from the distal end of the handle;

an electrode sheath carried on the distal end of the handle with the shape imparting mechanism being received within a lumen of the electrode sheath; and

a control mechanism carried on the handle for effecting control of the insertion facilitating arrangement of the shape imparting mechanism.

11. :

The assembly of claim 10 in which the control mechanism comprises a slider arrangement which is axially slidably arranged on the handle to facilitate displacement of the sleeve from its first position to its second position and vice versa.

12. :

The assembly of claim 10 in which the electrode sheath has a distal end pre-formed into a predetermined shape.

13. :

The assembly of claim 12 in which the pre-formed distal end of the electrode sheath has a shape corresponding to, and imparted by, the irregularly shaped configuration of the distal part of the elongate element.

14. :

An electrode sheath for a catheter, the electrode sheath comprising;

an elongate tubular element defining a lumen having a proximal end and a distal end; and

a distal part of the tubular element being shaped into a pre-determined configuration.

15. :

The electrode sheath of claim 14 in which the distal part of the tubular element is heat set into the predetermined configuration.

16. :

A method of fabricating an electrode sheath for a catheter, the method including;

providing an elongate tubular element having a malleable core, the core being removable;

forming a distal part of the tubular element into a predetermined, irregularly shaped configuration;

allowing the irregularly shaped distal part of the tubular element to set in that configuration; and

removing the core.

17. :

The method claim 16 which includes heat setting the tubular element, with the core therein, in heating equipment for a predetermined period of time and, thereafter, removing the core.

18. :

The method of claim 17 which includes, after heat setting the tubular element, straightening the tubular element to facilitate removal of the core and, after removal of the core, allowing the tubular element to revert to its irregularly shaped, heat set configuration.