Adapter for connection to pulse generator
Embodiments of the present invention generally pertain to devices and methods for use in conjunction with implanting a baroreflex therapy system which includes an implantable pulse generator and associated circuitry contained within a hermetically sealed housing, an elongate flexible electrical lead connectable to the housing, and a monopolar electrode structure coupled with the electrical lead. More specifically, the devices and methods of the present invention allow for a mapping procedure to be conducted as part of the implant procedure prior to fully implanting the baroreflex therapy system.
1. A method of implanting a baroreflex activation system within a patient, the baroreflex activation system including a control system contained within an implantable housing, an electrical lead, and a monopolar electrode coupled to the electrical lead, the method comprising:
creating an incision in a patient;
coupling the electrical lead to a header of the implantable housing;
inserting a temporary reference element subcutaneously into the patient;
coupling an adapter between the temporary reference element and the implantable housing;
performing a mapping procedure to determine a suitable implant location for the electrode proximate a blood vessel, the mapping procedure conducted between the monopolar electrode and the temporary reference element;
securing the monopolar electrode at the suitable implant location;
removing the adapter from the implantable housing; and
implanting the electrical lead and the implantable housing into the patient.
2. The method of claim 1 , further comprising causing the control system to deliver a baroreflex therapy via the monopolar electrode to a baroreceptor within a wall of the blood vessel.
3. The method of claim 2 , wherein the baroreflex therapy is configured to treat a physiological condition selected from the group consisting of: hypertension, heart failure, cardiovascular disorders, renal disorders, nervous system disorders and low blood pressure.
4. The method of claim 1 , wherein the blood vessel is selected from the group consisting of: a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, and a brachiocephalic artery.
5. The method of claim 1 , wherein the monopolar electrode comprises a cathode, and wherein the temporary reference element comprises an anode.
6. The method of claim 1 , further comprising securing the electrode at the suitable implant location such that the monopolar electrode is in contact with at least a portion of the blood vessel.
7. The method of claim 1 , further comprising securing the electrode at the suitable implant location such that the monopolar electrode is in the extravascular space proximate a blood vessel.
8. The method of claim 1 , wherein the mapping procedure is performed while the housing is not implanted in the patient.
9. The method of claim 1 , wherein the mapping procedure includes delivering a stimulation signal from the control system via the monopolar electrode and detecting the stimulation signal via the temporary reference element.
10. A method, comprising:
providing a baroreflex activation system, the system including a control system contained within an implantable housing, an electrical lead, and a monopolar electrode coupled to the electrical lead;
providing an implant kit, including:
a reference element, configured to be temporarily inserted subcutaneously in a patient; and
an implant adapter, including a first end configured to couple with the implantable housing and a second end configured to couple with the reference element, wherein the first end and second end are conductively coupled; and
providing instructions, comprising:
creating an incision in a patient;
coupling the electrical lead to a header of the implantable housing;
inserting the reference element subcutaneously into the patient;
coupling an adapter between the reference element and the implantable housing;
performing a mapping procedure to determine a suitable implant location for the electrode proximate a blood vessel, the mapping procedure conducted between the monopolar electrode and the reference element;
securing the monopolar electrode at a selected implant location;
removing the adapter from the implantable housing; and
implanting the electrical lead and the implantable housing into the patient.
11. The method of claim 10 , wherein the instructions further comprise securing the monopolar electrode at the suitable implant location such that the monopolar electrode is in contact with at least a portion of the blood vessel.
12. The method of claim 10 , wherein the blood vessel is selected from the group consisting of: a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, and a brachiocephalic artery.
13. The method of claim 10 , wherein the monopolar electrode comprises a cathode, and wherein the reference element comprises an anode.
14. The method of claim 10 , wherein the reference element comprises a needle.
15. The method of claim 10 , wherein the second end of the adapter comprises the reference element.
16. The method of claim 10 , wherein the instructions further comprise performing the mapping procedure while the housing is not implanted in the patient.
17. The method of claim 10 , wherein the instructions for performing the mapping procedure further comprise delivering a stimulation signal from the control system via the monopolar electrode and detecting the stimulation signal via the reference element.