STEERING AN IMPLANTABLE MEDICAL LEAD VIA A ROTATIONAL COUPLING TO A STYLET

• US 20120035616A1
• Filed: 04/27/2010
• Published: 02/09/2012
• Est. Priority Date: 04/30/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Olsen, James M., Stone, Richard T., Cai, Chad Q., Abraham, Timothy R., Klardie, Michael R., Boudhus, Spencer M., Conway, Mark J.
• Granted Patent: US 10,035,014 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0488 Details about the lead
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 2001/058 Fixing tools
• CPC Class Codes: A61N 2001/0582 Suture sleeves
• CPC Class Codes: Y10T 29/49016 Antenna or wave energy "plumbing" making
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/4921 with bonding
• CPC Class Codes: Y10T 29/49227 Insulator making
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An implantable medical lead has a torsional stiffness and is rotationally coupled to a stylet. Applying rotation directly to the lead in turn causes rotation of the stylet. Where the stylet has a bent tip for purposes of steering the lead, the rotation applied to the lead rotates the bent tip so that the lead can be steered by rotating the lead rather than rotating a hub of the stylet. The rotational coupling may be achieved through one or more features provided for the lead and/or the stylet, such as a feature within a lumen of the lead that mates to a feature along the stylet or a feature of the stylet hub that engages the proximal end of the lead. The torsional stiffness of the lead may be provided by adding a feature within the lead body, such as a braided metal wire or an overlapping foil.

Claims

1. A method of guiding an implantable medical lead, comprising:

providing the implantable medical lead with a torsional stiffness over a length of the implantable medical lead, the torsional stiffness being sufficient to impart rotation over the length when rotation is applied at a point along the length that includes the torsional stiffness; and

upon insertion of a stylet with a distal guide bend into a lumen of the implantable medical lead, providing a rotational coupling of the stylet to the implantable medical lead such that imparting rotation to the implantable medical lead at the point along the length imparts rotation to the stylet to direct the distal guide bend.

2. The method of claim 1, wherein providing the rotational coupling comprises providing a coupling feature within the lumen of the implantable lead, providing a coupling feature on the stylet, and mating the coupling feature within the lumen to the coupling feature on the stylet.

3. The method of claim 2, wherein the coupling feature within the lumen comprises at least one of a hexagonal passage, a star passage, and a square passage.

4. The method of claim 2, wherein the coupling feature on the stylet comprises at least one of a hexagonal shaft, a star shaped shaft, and a square shaped shaft.

5. The method of claim 1, wherein providing the rotational coupling comprises providing a coupling between a proximal end of the implantable medical lead and a hub of the stylet.

6. The method of claim 5, wherein the coupling between the proximal end of the implantable medical lead and the hub comprises at least one of a tapered frictional fit, a threaded fit, and a splined fit.

7. The method of claim 1, wherein providing the implantable medical lead with a torsional stiffness over a length of the implantable medical lead comprises including a metal shield within a jacket of the implantable medical lead.

8. The method of claim 7, wherein the metal shield comprises a metal wire braid.

9. An implantable medical lead kit, comprising:

an implantable medical lead with a torsional stiffness over a length of the implantable medical lead, the torsional stiffness being sufficient to impart rotation over the length when rotation is applied at any point along the length that includes the torsional stiffness; and

a stylet within a lumen of the implantable medical lead, the stylet having a distal guide bend and the stylet being rotationally coupled to the implantable medical lead when present within the lumen such that imparting rotation to the implantable medical lead at one or more points along the length imparts rotation to the stylet to direct the distal guide bend.

10. The implantable medical lead kit of claim 9, wherein the implantable medical lead comprises a coupling feature within the lumen, wherein the stylet comprises a coupling feature, and wherein the coupling feature of the implantable medical lead is mated to the coupling feature on the stylet.

11. The implantable medical lead kit of claim 10, wherein the coupling feature within the lumen comprises at least one of a hexagonal passage, a star passage, and a square passage.

12. The implantable medical lead kit of claim 10, wherein the coupling feature on the stylet comprises at least one of a hexagonal shaft, a star shaped shaft, and a square shaped shaft.

13. The implantable medical lead kit of claim 9, wherein a proximal end of the implantable medical lead is rotationally coupled to a hub of the stylet.

14. The implantable medical lead kit of claim 13, wherein the coupling between the proximal end of the implantable medical lead and the hub comprises at least one of a tapered frictional fit, a threaded fit, and a splined fit.

15. The implantable medical lead kit of claim 9, wherein the implantable medical lead comprises a metal shield within a jacket of the implantable medical lead that provides the torsional stiffness over the length of the implantable medical lead.

16. The implantable medical lead kit of claim 15, wherein the metal shield comprises a metal wire braid.

17. A method of guiding an implantable medical lead, comprising:

inserting a stylet with a distal guide bend into a lumen of the implantable medical lead to rotationally couple the stylet to the implantable medical lead such that imparting rotation to the implantable medical lead at one or more points along the length imparts rotation to the stylet; and

directing the implantable medical lead in a desired direction by imparting rotation to the implantable lead to cause rotation of the stylet to a desired rotational position, wherein the distal guide bend urges the implantable medical lead in the desired direction; and

applying insertion force to the implantable medical lead.

18. The method of claim 17, wherein the implantable medical lead comprises a shield that creates a torsional stiffness over a length of the implantable medical lead, the torsional stiffness being sufficient to impart rotation over the length when rotation is applied at a point along the length that includes the torsional stiffness.

19. The method of claim 17, wherein the implantable medical lead rotationally couples to the stylet by mating a coupling feature of the implantable medical lead to a coupling feature of the stylet.

20. The method of claim 17, wherein the implantable medical lead rotationally couples to the stylet by rotationally coupling a hub of the stylet to a proximal end of the implantable medical lead.