Implantable pulse generator for providing functional and/or therapeutic stimulation of muscles and /or nerves and/or central nervous system tissue

• US 20050277999A1
• Filed: 06/10/2005
• Published: 12/15/2005
• Est. Priority Date: 06/10/2004
• Status: Active Grant

• Current Assignee: Medtronic Urinary Solutions, Inc. (Medtronic Plc)
• Original Assignee: NDI Medical, LLC
• Inventors: Strother, Robert B., Mrva, Joseph J., Thrope, Geoffrey B.
• Granted Patent: US 7,239,918 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/904 Telephone telemetry

Abstract

Improved assemblies, systems, and methods provide an implantable pulse generator for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The implantable pulse generator is sized and configured to be implanted subcutaneous a tissue region. The implantable pulse generator includes an electrically conductive case of a laser welded titanium material. Control circuitry is located within the case, the control circuitry including a rechargeable power source, a receive coil for receiving an RF magnetic field to recharge the power source, and a microcontroller for control of the implantable pulse generator. Improved assemblies, systems, and methods also provide a stimulation system for prosthetic or therapeutic stimulation of muscles, nerves, or central nervous system tissue, or any combination. The stimulation system provides at least one electrically conductive surface, a lead connected to the electrically conductive surface, and an implantable pulse generator electrically connected to the lead.

Claims

1. A neuromuscular stimulation system comprising:

at least one electrically conductive surface sized and configured for implantation in a targeted neural or muscular tissue region,

a lead electrically coupled to the electrically conductive surface, the lead sized and configured to be positioned subcutaneous a tissue surface,

an implantable pulse generator sized and configured to be positioned subcutaneous to a tissue surface remote from at least one electrically conductive surface, the implantable pulse generator comprising wireless telemetry circuitry, the wireless telemetry circuitry being functional within arms reach of the patient, and being adapted for programming and interrogation of the implantable pulse generator.

2. A system according to claim 1

Wherein the MES processor includes an antenna coupled to the implantable pulse generator for transmission and reception of wireless telemetry signals.

3. A system according to claim 2 further including:

a clinician programmer adapted to download program stimulus parameters and stimulus sequence parameters into the implantable pulse generator, and to upload operational data from the implantable pulse generator, the clinician programmer acting as the master and utilizing wireless telemetry to communicate with the implantable pulse generator.

4. A system of claim 3

wherein the clinician programmer employs the conduit connection employed by hand-held or web-based devices.

5. A system according to claim 1

wherein the MES processor includes a lead connection header coupled to the MES processor for electrically coupling the lead to the MES processor, the lead connection header enabling reliable replacement of the MES processor.

6. A system according to claim 1

wherein the implantable pulse generator is powered by a rechargeable battery source.

7. A system according to claim 1

wherein the implantable pulse generator includes a case having a size as small as between about 5 mm and about 10 mm thick, between about 45 mm and about 60 mm wide, and between about 45 mm and about 60 mm long.

8. A system according to claim 1

wherein the implantable pulse generator is sized and configured for implanting in subcutaneous tissue at an implant depth of between about 0.5 cm and about 1.5 cm.

9. A system according to claim 1

wherein the implantable pulse generator includes at least one power management operating mode.

10. A system according to claim 1

wherein the implantable pulse generator includes at least three power management operating modes including an active mode, an idle mode, and a dormant mode.

11. A system according to claim 1

wherein the implantable pulse generator outputs a a pulse having a biphasic waveform, the biphasic waveform including a net DC current of less than about 10 μ

A, an interphase delay, an amplitude of up to about 15 mA, and a pulse duration up to about 500 μ

sec.

12. A system according to claim 1

wherein the implantable pulse generator provides stimulus pulses for the treatment of urinary incontinence, or fecal incontinence, or micturition/retention, or defecation/constipation, or restoration of sexual function, or pelvic floor muscle activity, or pelvic pain, or deep brain stimulation in the treatment of (i) Parkinson'"'"'s disease;

(ii) multiple sclerosis;

(iii) essential tremor;

(iv) depression;

(v) eating disorders;

(vi) epilepsy;

(vii) minimally conscious state, or pain management by interfering with or blocking pain signals from reaching the brain in the treatment of (i) peripheral neuropathy;

(ii) cancer, or obstructive sleep apnea.

13. A method of using the system defined in claim 1.