STYLET FOR GUIDING LEADS OF IMPLANTABLE ELECTRIC STIMULATION SYSTEMS AND METHODS OF MAKING AND USING

• US 20100042109A1
• Filed: 08/04/2009
• Published: 02/18/2010
• Est. Priority Date: 08/12/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Granted Patent: US 8,469,971 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A lead assembly includes a lead and a stylet. The lead has a distal end, a proximal end, and an outer lead covering. The lead includes a plurality of electrodes disposed at the distal end, a plurality of terminals disposed at the proximal end, and at least one lumen defined in the lead that extends from the distal end to the proximal end. The lead also includes a plurality of conductive wires electrically coupling the plurality of electrodes to the plurality of terminals. The stylet is configured and arranged for inserting into one of the at least one lumens of the lead. The stylet includes an elongated body and a protective feature that is coupled to the elongated body. The protective feature is configured and arranged for absorbing or redirecting an amount of force applied to the stylet above a threshold amount of force.

Claims

1. A lead assembly comprising:

a lead with a distal end, a proximal end, and an outer lead covering, the lead comprising

a plurality of electrodes disposed at the distal end,

a plurality of terminals disposed at the proximal end,

at least one lumen defined in the lead, the at least one lumen extending from the distal end to the proximal end, and

a plurality of conductive wires electrically coupling the plurality of electrodes to the plurality of terminals; and

a stylet configured and arranged for insertion into a one of the at least one lumens of the lead, the stylet comprising

an elongated body with a distal portion and a proximal portion, and

a protective feature coupled to the elongated body, the protective feature configured and arranged for absorbing or redirecting an amount of force applied to the stylet above a threshold amount of force.

2. The lead assembly of claim 1, wherein the threshold amount of force is no greater than a minimum amount of force needed for the distal portion of the elongated body of the stylet to damage or penetrate the outer lead covering of the lead.

3. The lead assembly of claim 1, wherein the protective feature comprises at least one loop disposed in the proximal portion of the elongated body of the stylet.

4. The lead assembly of claim 3, wherein the at least one loop is configured and arranged for absorbing or redirecting an amount of force applied to the stylet above the threshold amount of force when the stylet is inserted into the at least one lumen by expanding the at least one loop so that the diameter of the at least one loop expands.

5. The lead assembly of claim 1, wherein the protective feature comprises at least one kinked section disposed in the proximal portion of the elongated body of the stylet.

6. The lead assembly of claim 5, wherein the at least one kinked section is configured and arranged for absorbing or redirecting an amount of force applied to the stylet above the threshold amount of force when the stylet is inserted into the at least one lumen by flexing.

7. The lead assembly of claim 1, wherein the protective feature comprises at least one reduced-diameter section disposed in the proximal portion of the elongated body of the stylet.

8. The lead assembly of claim 7, wherein the at least one reduced-diameter section is configured and arranged for absorbing or redirecting an amount of force applied to the stylet above the threshold amount of force when the stylet is inserted into the at least one lumen by buckling.

9. An electrical stimulating system comprising:

the lead assembly of claim 1;

a control module configured and arranged to electrically couple to the first proximal end and the at least one second proximal end, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector configured and arranged to receive the lead, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the lead or the lead extension, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the lead or the lead extension.

10. A stylet comprising

an elongated body with a distal portion, a proximal portion, and a proximal tip;

and

a cap having a proximal end and a distal end, the cap comprising

an inner housing defining a central lumen, the central lumen configured and arranged to receive the proximal portion of the elongated body, the inner housing comprising an interference flange and at least one clamping member, the at least one clamping member configured and arranged for providing resistive force against the elongated body,

an outer housing comprising an outer flange configured and arranged to press against at least one of the clamping members, and

a compressed spring positioned between the interference flange and the outer flange, an initial compression value of the compressed spring at least partially determining the amount of force with which the outer flange presses against at least one of the clamping members.

11. The stylet of claim 10, further including a port defined in the proximal end of the outer housing, the port configured and arranged to receive the proximal tip of the elongated member.

12. The stylet of claim 10, further including an extension tube disposed in the proximal end of the outer housing, the extension tube configured and arranged to receive the proximal tip of the elongated body.

13. The stylet of claim 10, wherein the proximal tip of the elongated body is curled.

14. The stylet of claim 10, wherein the proximal portion of the elongated body comprises at least one section with a non-circular cross-sectional shape.

15. A lead assembly comprising

a lead with a distal end and a proximal end, the lead comprising

a plurality of electrodes disposed at the distal end,

a plurality of terminals disposed at the proximal end,

at least one lumen defined in the lead, the at least one lumen extending from the distal end to the proximal end, and

a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals;

and

the stylet of claim 10.

16. An electrical stimulating system comprising:

a lead with a distal end and a proximal end, the lead comprising

a plurality of electrodes disposed at the distal end,

a plurality of terminals disposed at the proximal end,

at least one lumen defined in the lead, the at least one lumen extending from the distal end to the proximal end, and

a plurality of conductive wires electrically coupling the plurality of electrodes electrically to the plurality of terminals;

the stylet of claim 10;

a control module configured and arranged to electrically couple to the first proximal end and the at least one second proximal end, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector configured and arranged to receive the lead, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the lead or the lead extension, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the lead or the lead extension;

17. A method for stimulating patient tissue, the method comprising:

disposing a distal portion of a stylet into one or more lumens defined in a lead;

inserting the lead and stylet into a patient, the lead comprising a plurality of electrodes disposed on a distal end electrically coupled to a plurality of terminals disposed on a proximal end by a plurality of conductive wires electrically coupling at least one terminal to at least one electrode;

guiding the lead and stylet to a desired location in the patient using a cap disposed on a proximal portion of the stylet, the stylet comprising a protective feature to absorb or redirect an amount of force applied to the cap above a preselected force threshold while guiding the lead and stylet;

removing the stylet from the lead;

disposing the proximal end of the lead into a connector, the connector defining a port for receiving the proximal end of the lead, the port comprising a plurality of connective contacts that electrically couple to at least one of the plurality of terminals, the connector electrically coupled to a control module;

providing electrical signals from the control module to electrically stimulate patient tissue using at least one of the electrodes on the lead.

18. The method of claim 17, wherein guiding the lead and stylet to the desired location in the patient using the cap comprises the protective feature being disposed on the elongated body.

19. The method of claim 17, wherein guiding the lead and stylet to a desired location in the patient using the cap comprises the protective feature being disposed on the cap.

20. The method of claim 17, wherein guiding the lead and stylet to a desired location using the cap comprises receiving a tactile signal from the protective feature when the amount of force applied to the cap exceeds a threshold amount of force.