Percutaneous tibial nerve stimulator

• US 8,660,646 B2
• Filed: 06/15/2012
• Issued: 02/25/2014
• Est. Priority Date: 06/16/2011
• Status: Active Grant

• Current Assignee: Advanced Uro-Solutions, LLC (Medtronic Plc)
• Original Assignee: Advanced Uro-Solutions, LLC (Medtronic Plc)
• Inventors: Laing, Brent, Green, John David
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/523,965
• Publication Number:
  US 20120323294A1
• Time in Patent Office: 620 Days
• Field of Search: 607 39- 41
• US Class Current: 607/39
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G06Q 20/22 Payment schemes or models
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Abstract

A tibial nerve stimulation device including a percutaneous electrode for inserting adjacent a stimulation site of a patient and a neurostimulator unit attachable to a transcutaneous electrode configured to be applied to skin adjacent the stimulation site. The neurostimulator unit includes a pulse generator electrically coupled to the percutaneous needle electrode and transcutaneous electrode and a microcontroller in communication with the pulse generator for monitoring a number of available treatment credits and activating the pulse generator, each available treatment credit corresponding to a treatment session and the pulse generator operable to be activated for performing the treatment session when the number of available treatment credits is at least one. A computer system is operable to communicate with the microcontroller of the neurostimulator unit for receiving a treatment credit request and transmitting the number of treatment credits purchased to the microcontroller of the neurostimulator unit.

Claims

1. A method for providing a reusable nerve stimulation system to treat incontinence, the method comprising:

providing a computer system having a customer interface;

providing a neurostimulator unit including;

a pulse generator for electrically coupling to a transcutaneous electrode configured to be applied to skin adjacent a stimulation site of a patient and a percutaneous electrode having a leading end for inserting adjacent the stimulation site of a patient, and

a microcontroller in communication with the pulse generator for monitoring a number of available treatment credits to the neurostimulator unit and for activating the pulse generator during a treatment session when the number of available treatment credits is at least one;

receiving at the computer system a treatment credit request transmitted through the customer interface, each treatment credit request having purchase information including a number of treatment credits purchased, each treatment credit purchased corresponding to an available treatment credit;

transmitting the number of treatment credits purchased to the microcontroller of the neurostimulator unit; and

adjusting the number of treatment credits available to the neurostimulator unit based on the number of treatment credits purchased transmitted to the microcontroller of the neurostimulator unit.

2. The method of claim 1 further comprising:

determining whether the number of available treatment credits is at least one; and

activating the pulse generator based on a treatment session request when it is determined that the number of available treatment credits is at least one.

3. The method of claim 1 further comprising:

transmitting usage information from the microcontroller to the computer system, the usage information including a number of treatment sessions performed;

monitoring the usage information of the neurostimulator unit through the computer system; and

providing the usage information to a customer through a customer interface of the computer system.

4. The method of claim 1 further comprising:

providing each treatment credit purchased with a unique serial number;

monitoring usage information of each treatment credit purchased at the neurostimulator unit;

transmitting the usage information from the neurostimulator unit to the computer system for each treatment credit purchased based on the unique serial number.

5. The method of claim 1 wherein the pulse generator is dimensioned and configured to be removeably attached to the transcutaneous electrode.

6. The method of claim 1 wherein the computer system transmits the number of treatment credits purchased to the microcontroller wirelessly through one of radio frequency, Bluetooth, infrared, and a wireless internet connection.

7. The method of claim 1 wherein the computer system transmits the number of treatment credits purchased to the microcontroller through a universal serial bus connection.

8. A method for providing a reusable nerve stimulation system to treat incontinence, the method comprising:

providing at least one neurostimulator unit to a customer, each neurostimulator unit including;

a pulse generator for electrically coupling to a transcutaneous electrode configured to be applied to skin adjacent a stimulation site of a patient and a percutaneous needle electrode having a removable leading end for inserting adjacent the stimulation site of the patient, and

a microcontroller in communication with the pulse generator for monitoring a number of available treatment credits to the neurostimulator unit;

linking each of the neurostimulator units to a customer account, the customer able to access the customer account through a customer interface of a computer system;

receiving at the computer system a treatment credit request from the customer transmitted through the customer interface, the treatment credit request having purchase information including a number of treatment credits purchased to be stored in the customer account;

connecting at least one of the neurostimulator units to the computer system;

transmitting at least one of the treatment credits purchased from the customer account to the microcontroller of the connected neurostimulator unit;

adjusting the number of available treatment credits to the neurostimulator unit and the number of treatment credits purchased stored in the customer account based on the number of treatment credits purchased transmitted to the microcontroller; and

activating the pulse generator upon request by the customer to generate current pulses that pass between the transcutaneous electrode and the percutaneous electrode for providing stimulation to the stimulation site during one or more treatment sessions, the pulse generator able to be activated only when the number of available treatment credits to the neurostimulator unit is at least one.

9. The method of claim 8 further comprising:

transmitting usage information from the microcontroller to the computer system, the usage information including a number of treatment sessions performed;

monitoring the usage information of the neurostimulator unit through the computer system; and

providing the usage information to the customer through the customer interface of the computer system.

10. The method of claim 8 further comprising attaching the pulse generator to the transcutaneous electrode prior to activating the pulse generator.

11. The method of claim 10 further comprising providing a handheld unit for wirelessly communicating the activation request to the neurostimulator unit.

12. The method of claim 8 wherein the connecting of the neurostimulator unit and computer system and the transmitting of the treatment credits purchased from the customer account to the microcontroller of the connected neurostimulator unit is performed wirelessly.

13. The method of claim 8 further comprising inserting the leading end of the percutaneous needle electrode adjacent the stimulation site of the patient, the stimulation site being adjacent a tibial nerve.