FULLY IMPLANTABLE TRIAL NEUROSTIMULATION SYSTEM CONFIGURED FOR MINIMALLY-INTRUSIVE IMPLANT/EXPLANT

• US 20150018838A1
• Filed: 07/12/2013
• Published: 01/15/2015
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Nabutovsky, Yelena, Bornzin, Gene A., Kaiser, Melanie Goodman
• Granted Patent: US 10,610,690 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

Abstract

A fully implantable trial neurostimulation system for implant within a patient is provided that includes one or more leads equipped to deliver neurostimulation to patient tissues under the control of a trial neurostimulation control device designed as a capsule for removable implant within the patient. The control capsule is provided with minimal components to power and control the delivery of neurostimulation during a trial evaluation period and is shaped and configured to facilitate removal from the patient following completion of the trial period. In some examples, both the lead and the trial control capsule are removed from the patient following the trial period for replacement with a chronic or long-term neurostimulation system (assuming further neurostimulation is warranted.) In other examples, the lead remains within the patient and the trial control capsule is replaced with a long-term neurostimulation controller device. Various minimally-intrusive implantation procedures are also described.

Claims

1. A fully implantable neurostimulation system for implant within a patient, the system comprising:

a neurostimulation lead equipped to deliver neurostimulation to patient tissues; and

a trial neurostimulation device for removable non-chronic implant within the patient,

the trial neurostimulation device equipped to control delivery of trial neurostimulation using the lead and configured to facilitate removal from the patient following completion of a trial neurostimulation period.

2. The neurostimulation system of claim 1 wherein the neurostimulation lead is also configured for removable implant.

3. The neurostimulation system of claim 1 wherein the neurostimulation lead is detachable from the trial neurostimulation device and configured for chronic implant within the patient.

7. The neurostimulation system of claim 1 wherein the trial neurostimulation device includes a tab configured to facilitate extraction of the device from the patient.

8. The neurostimulation system of claim 1 wherein the trial neurostimulation device is a capsule having a substantially smoothed bullet shape.

9. The neurostimulation system of claim 1 wherein the trial neurostimulation device is sufficiently small to fit through a Touhy needle.

10. The neurostimulation system of claim 1 wherein the trial neurostimulation device is biologically nonhermetic.

11. The neurostimulation system of claim 1 wherein the trial neurostimulation device includes potted components in epoxy.

12. The neurostimulation system of claim 1 wherein the trial neurostimulation device includes a power source equipped for delivering power during, but not substantially beyond, the trial neurostimulation period,

13. The neurostimulation system of claim 1 wherein the trial neurostimulation device includes an antenna operative to receive wireless signals from an external system.

4. The neurostimulation system of claim I wherein the neurostimulation lead is a percutaneous lead.

5. The neurostimulation system of claim 4 wherein the percutaneous lead is a percutaneous paddle lead.

6. The neurostimulation system of claim I wherein the trial neurostimulation device is a capsule configured for subcutaneous implant.

14. A method for implanting a fully implantable neurostimulation system within a patient, the system having a neurostimulation lead equipped to deliver neurostimulation to patient tissues and a non-chronic trial neurostimulation device for removable implant within the patient during a trial neurostimulation period, the method comprising:

inserting a guidewire into tissues of the patient;

inserting an introducer sheath having a dilator;

removing the guidewire and the dilator;

inserting the neurostimulation lead and the trial neurostimulation device via the sheath; and

removing the sheath to leave the neurostimulation lead and the trial neurostimulation device within the patient,

15. The method of claim 14 wherein inserting the guidewire into subcutaneous tissues of the patient is performed using a Touhy needle and wherein the needle is removed following insertion of the guidewire.

16. The method of claim 15 wherein removing the sheath is performed by splitting the sheath.

17. The method of claim 14 further including the step of removing at least the trial neurostimulation device following the trial period.

18. The method of claim 17 further including the step of also removing the lead following the trial period.

19. The method of claim 17 further including the step of implanting a chronic neurostimulation device following the trial period,

20. A method for implanting a fully implantable neurostimulation system within a patient, the system having a neurostimulation lead equipped to deliver neurostimulation to patient tissues and a trial neurostimulation device for removable implant within the patient during a non-chronic trial neurostimulation period, the method comprising:

inserting a guidewire into tissues of the patient using a splittable needle, the needle of sufficient width to accommodate insertion of the neurostimulation lead and the trial neurostimulation device;

inserting the neurostimulation lead and the trial neurostimulation device into patient tissue via the needle; and

splitting the needle and then removing the spit needle from the patient to leave the neurostimulation lead and the trial neurostimulation device within the patient.