Multiprogrammable tissue stimulator and method

• US 20030195591A1
• Filed: 05/23/2003
• Published: 10/16/2003
• Est. Priority Date: 06/07/1996
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Erickson, John, Campen, George Van, Ehren, Lance, Law, Jay
• Granted Patent: US 7,127,297 B2
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

An electronic stimulation system is used to control pain over multiple regions of a patient'"'"'s body. The system has one or more percutaneous leads, each having multiple electrodes, implanted within the patient'"'"'s epidural space parallel to the axis of the spinal cord. The leads are connected to either a totally implanted system or a radio frequency system. The system is able to treat pain over different regions of a patient'"'"'s body by “simultaneously” stimulating the patient with at least three different stimulation settings. “Simultaneous” stimulation involves sequentially stimulating the patient with the multiple stimulation settings such that the patient receives the cumulative effect of each stimulation setting, while not perceiving the transition from one stimulation setting to another.

Claims

1. An improved electric tissue stimulation system having a transmitting means, receiving means and at least one electrically coupled multi-electrode means, the transmitting means transmitting stimulation data to the surgically implanted receiving means for delivery of an electrical pulse through the at least one multi-electrode means implanted at selected tissue site(s), the system comprising:

a) control means;

b) means for storing at least three stimulation settings, connected to and programmable by the control means, to store at least three electrode stimulation settings;

c) means for selecting each of the at least three stimulation settings, programmable by the control means, to select at least one stimulation setting form the means for storing at least three stimulation settings, the receiving means generating an electrical pulse in accordance with that selected stimulation setting.

2. The improved system of claim 1, wherein control means selects more than one stimulation setting, a series of substantially sequential stimulation pulses are delivered, each stimulation pulse corresponding to a selected stimulation setting, wherein a patient receives cumulative stimulation in all bodily regions addressed by the selected stimulation setting.

3. The improved system of claim 1, wherein such system possesses at least two multi-electrode means, and each stimulation setting may define an electrical pulse which emanates from a single multi-electrode means or utilizes at least two multi-electrode means.

4. The improved system of claim 1 further comprising manual input means allowing a user to input and modify any stimulation setting.

5. The improved system of claim 1 further comprising a connection means and a general purpose computer, wherein the connection means permits the coupling of the transmitting means to the general purpose computer to allow a user to input and modify any stimulation setting.

6. The improved system of claim 5, wherein the connection means is a serial port utilizing a standard RS232 connection.

7. The improved system of claim 1, wherein the transmitting means is an RF modulator, the RF modulator impressing stimulation data onto a radio frequency carrier signal to form a stimulation signal, the stimulation signal being broadcast to the implanted receiving means.

8. The improved system of claim 1, wherein the transmitting means is an external telemetry programming source and said receiving means is a totally implanted, internally-powered pulse generator.

9. An improved electric tissue stimulator system having a transmitting means to transmit stimulation data to a receiving means, surgically implanted within a patient, which receives the stimulation data and emanates electrical pulses to be delivered via at least one electrically coupled multi-electrode means implanted at a selected tissue site(s), the system comprising:

a) a control means;

b) means for storing at least three stimulation settings, connected to and programmable by control means, to store at least three electrode stimulation settings'"'"'

c) means for selecting each of the at least three stimulation settings, connected to and programmable by control means to select at least one stimulation setting from the means for storing at least three stimulation settings, receiving means emanating a stimulation pulse in accordance with that selected stimulation setting,

wherein control means selects more than one stimulation setting, the receiving means generates a series of substantially sequential stimulation pulses, each stimulation pulse corresponding to that selected stimulation setting, such that the patient perceives cumulative stimulation to all bodily regions addressed by the selected stimulation settings.

10. The improved system of claim 9, wherein such system possesses at least two multi-electrode means, each stimulation setting defining a generated pulse which may be delivered via a single multi-electrode means or at least two multi-electrode means.

11. The improved system of claim 9 further comprising manual input means allowing a user to input and modify stimulation settings.

12. The improved system of claim 9 further comprising a connection means for connecting the transmitting means to a general purpose computer to allow a user to input and modify stimulation settings.

13. The improved system of claim 12, wherein the connection means is a serial port utilizing a standard RS232 connection.

14. The improved system of claim 9, wherein the transmitting means is an RF modulator, the RF modulator impressing stimulation data onto a radio frequency carrier signal to form a stimulation signal, the stimulation signal being broadcast to the implanted receiving means.

15. The improved system of claim 9, wherein the transmitting means is an external telemetry programming source and said receiving means is a totally implanted, internally-powered pulse generator.

16. The improved system of claim 9, wherein control means is a microcomputer.

17. An improved electric tissue stimulator system having a transmitting means to transmit stimulation data to a receiving means, surgically implanted within a patient, which receives the stimulation data and generates stimulation pulses to be delivered via at least one coupled, multi-electrode means, the system comprising:

a) at least three setting data registers to store at least three stimulation settings;

b) at least three variable parameter registers to store at least three variable parameters, each variable parameter register corresponding to a stored stimulation setting;

c) a controller, coupled to the setting data registers and the variable parameter registers, to select a stimulation setting and a corresponding variable parameter to generate a stimulation pulse; and

d) pulse generation circuitry, connected to the at least three setting data registers, the at least three variable parameter registers and the controller, to generate a stimulation pulse which is characteristic of the selected stimulation setting and corresponding variable parameter, each stimulation pulse being delivered via the at least one multi-electrode means.

18. The improved system of claim 17 further comprising a time internal generator, programmable by and coupled to the controller, wherein the time interval generator switches between each of the stimulation settings and corresponding variable parameters at a programmable interval, such that patent perceives simultaneous stimulation at each site addressed by each selected stimulation setting.

19. The improved system of claim 17 further comprising a computer interface and a general purpose computer, allowing the transmitter means to be connected to the general purpose computer to retrieve patient information and stimulation settings as well as permit a user to add and reprogram stimulation settings.

20. The improved system of claim 17 further comprising a display and a keypad, the display and the keypad allowing a user to display and modify the stimulation settings.

21. The improved system of claim 17, wherein the system possesses at least two multi-electrode means, each stimulation setting may define a unilateral stimulation pulse or a bilateral stimulation pulse.

22. A method of electrically stimulating tissue through at least a partially implanted system which includes a programming means, a receiving means, and at least one multi-electrode means, comprising the steps of:

a) surgically implanting the receiving means and the at least one multi-electrode means within a patient, the multi-electrode means being placed at or about tissue intended to be stimulated;

b) electing one or more programmed stimulation settings, each stimulation setting corresponding to a differing region of pain and being stored within the programming means and;

c) transmitting at least three differing stimulation settings between the programming means and the receiving means;

d) emanating a stimulation pulse, of a defined duration, for each elected stimulation setting through and by at least one multi-electrode means.

23. The method of claim 22 further including the step of automatically delivering each stimulation pulse in a substantially sequential manner.

24. The method of claim 23 wherein each delivered stimulation pulse slightly overlaps a preceding stimulation pulse.

25. The method of claim 23 wherein an imperceivable time delay separate each stimulation pulse.

26. The method of claim 23 wherein each stimulation pulse is delivered by at least two multi-electrode means, the stimulation settings may define a unilateral stimulation pulse or a bilateral stimulation pulse.