Apparatus for baroreceptor stimulation therapy

• US 10,029,091 B2
• Filed: 02/20/2015
• Issued: 07/24/2018
• Est. Priority Date: 02/20/2014
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mokelke, Eric A., Arcot-Krishnamurthy, Shantha, Soltis, Brian, Hamann, Jason J.
• Primary Examiner(s): Hulbert, Amanda
• Application Number:
  US14/627,380
• Publication Number:
  US 20150231391A1
• Time in Patent Office: 1,250 Days
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

A medical apparatus comprising an implantable lead and a stylet configured for stimulation of a target region of a patient'"'"'s nervous system is described. The lead includes a generally tubular lead body, a conductor, and an electrode assembly. The generally tubular lead body has a stylet lumen and a conductor lumen extending through the proximal and distal ends of the lead body. The conductor is enclosed within the conductor lumen. The electrode assembly extends from the distal end of the lead body. The electrode assembly includes a flexible polymeric carrier and an electrode on the carrier and electrically coupled to the conductor. The stylet is sized and shaped to be receivable within the stylet lumen and configured to stiffen and support the lead body. The distal portion of the stylet includes a bend having a predetermined angle of incidence relative to the proximal portion of the stylet.

Claims

1. A medical apparatus, comprising:

an implantable lead for stimulation of a target region of a patient'"'"'s nervous system, the lead comprising;

a generally tubular lead body having a proximal end, an opposite distal end, a stylet lumen and a conductor lumen, the stylet and conductor lumens extending through the proximal and distal ends of the tubular lead body;

a conductor enclosed within the conductor lumen;

an electrode assembly extending from the distal end of the lead body, the electrode assembly including a flexible polymeric carrier, and an electrode on the carrier and electrically coupled to the conductor; and

a stylet sized and shaped to be receivable within the stylet lumen and configured to stiffen and support the lead body, wherein the stylet includes a proximal portion and a distal portion, wherein a temporary anchoring element is coupled to a distal end of the distal portion of the stylet, wherein the temporary anchoring element is configured to extend from, and retract into, the distal end of the stylet.

2. The medical apparatus of claim 1, wherein the lead body includes a first tubular member and a second tubular member secured to the first tubular member, the stylet lumen extending through the first tubular member, wherein the first tubular member is separable from the second tubular member.

3. The medical apparatus of claim 1, wherein the lead body further comprises a separable interface between the first tubular member and the second tubular member, wherein the stylet is detachable from the lead body at the separable interface by removing the first tubular member along the separable interface.

4. The medical apparatus of claim 1, wherein the temporary anchoring element comprises a barb configured to pierce patient tissue in order to engage with the patient tissue.

5. The medical apparatus of claim 4, wherein the barb comprises a tip portion configured to engage with the patient tissue.

6. The medical apparatus of claim 4, wherein the temporary anchoring element comprises a fixation helix with a sharp tip portion that is configured to be extendable from and retractable with respect to the distal end of the stylet when the stylet is rotated relative to the lead body.

7. The medical apparatus of claim 1, wherein the conductor lumen and the stylet lumen are situated in a side-by-side arrangement.

8. The medical apparatus of claim 1, further comprising a second conductor enclosed within a second conductor lumen.

9. The medical apparatus of claim 8, further comprising a second electrode electrically coupled to the second conductor.

10. The medical apparatus of claim 9, wherein the lead body includes a first tubular member, the stylet lumen extending through the first tubular member, wherein the first tubular member has a circular opening at a distal end of the first tubular member and wherein the stylet is configured to extend past and retract into the first tubular member through the circular opening.

11. The medical apparatus of claim 1, wherein the carrier is composed of a silicone-based material.

12. A method of implanting an implantable lead for stimulation of the baroreceptors located within a carotid sinus of a patient, the method comprising:

advancing a stylet into a stylet lumen of a lead body of the implantable lead, the lead body comprising the stylet lumen and a conductor lumen, wherein a conductor is enclosed within the conductor lumen, and wherein the stylet is sized and shaped to be receivable within the stylet lumen, wherein the stylet is configured to stiffen and support the lead body and includes a proximal portion and a distal portion, wherein a temporary anchoring element is coupled to a distal end of the distal portion, and wherein the temporary anchoring element is configured to extend from, and retract into, the distal end of the stylet; and

positioning an electrode of the implantable lead proximate to a target physiological region of a patient by using the stylet to stiffen and support the lead body, wherein the electrode is electrically coupled to the conductor at a distal end of the conductor.

13. The method of claim 12, further comprising rotating the stylet to expose the temporary anchoring element.

14. The method of claim 13, further comprising engaging the temporary anchoring element with patient tissue.

15. The method of claim 14, further comprising:

securing the electrode to the patient; and

removing the stylet from the medical apparatus upon securing the electrode to the patient.

16. The method of claim 15, wherein removing the stylet from the medical apparatus comprises removing a first tubular member defining the stylet lumen from the medical apparatus, wherein the stylet remains enclosed within the first tubular member while removing the first tubular member.