Nerve stimulation system with programmed pulse charge attenuation

• US 8,571,666 B2
• Filed: 07/31/2006
• Issued: 10/29/2013
• Est. Priority Date: 08/02/2005
• Status: Active Grant

• Current Assignee: William F. Urmey
• Original Assignee: William F. Urmey
• Inventors: Urmey, William F.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US11/461,308
• Publication Number:
  US 20070032841A1
• Time in Patent Office: 2,647 Days
• Field of Search: 607/46, 607/47, 607/72
• US Class Current: 607/46
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A processor implemented nerve stimulation system for regional anesthesia administration varies pulse width as a programmed function of applied current or varies applied current as a function of adjusted pulse width. The system also provides a waveform of repeating cycles of different pulse width components separated within the waveform frequency and which may be simultaneously attenuated as a function of applied current within an attenuation range. Among possible functional relationships between pulse width and applied current within an attenuation range is the exponential reduction of pulse width as a function of applied current.

Claims

1. A nerve stimulation system configured to position an administration needle proximate a target nerve, the system comprising:

an operator interface including an operator input;

a pulse generator configured to generate a pulse output waveform at an output terminal, wherein the pulse output waveform comprises pulses, each pulse having a pulse charge comprising a function of a first variable parameter and a second variable parameter, the variable parameters comprising pulse current amplitude and pulse width;

a controller operatively connected to the pulse generator and to the operator interface; and

an administration needle configured for administration of an anesthetic, the administration needle operatively connected to the output terminal;

wherein the operator input is configured to input signals to the controller and incrementally reduce the value of the first variable parameter and the controller is programmed to reduce the value of the second variable parameter as a function of incrementally set values of the first variable parameter.

2. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 1, wherein the function is exponential.

3. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 2, wherein the first variable parameter comprises pulse current amplitude and the second variable parameter comprises pulse width.

4. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 1, wherein the first variable parameter comprises pulse current amplitude and the second variable parameter comprises pulse width.

5. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 4, wherein the controller maintains constant pulse width over an initial range of incrementally set pulse current amplitude values and thereafter attenuates pulse width over an attenuation range of reduced incrementally set pulse current amplitude values.

6. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 4, wherein the controller maintains constant pulse width when current amplitude values are reduced below the attenuation range.

7. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 4, wherein the pulses are configured in a pulse train having repeating cycles of three different pulse width components separated by ⅓

of the waveform frequency.

8. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 7, wherein the controller is programmed to simultaneously reduce the value of the pulse width parameter of each pulse width component as a function of an incrementally reduced value of the pulse amplitude parameter.

9. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 1, wherein the function has been empirically derived.

10. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 1, the controller being programmed with multiple modes of operation.

11. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 10, wherein the pulse generator generates a pulse output waveform comprising repeating cycles of three different pulse width components separated by ⅓

of the waveform frequency and the operator input is configured to input a signal to the controller to incrementally vary the pulse current amplitude of each of the pulse width components.

12. A method of programming the controller of a nerve stimulation system constructed in accordance with claim 1, wherein the target nerve is situate in a subject, the method comprising the steps of:

i) introducing the administration needle into the subject at a location anatomically positioned for locating the target nerve to elicit stimulation of the target nerve,

ii) incrementally advancing the administration needle toward the target nerve while incrementally reducing the pulse current amplitude,

iii) reducing the pulse width to maintain stimulation while performing step ii),

iv) observing correlated values of pulse current amplitude and pulse width for maintaining stimulation while performing steps ii) and iii), and

v) programming the controller with a transfer function of pulse current amplitude versus pulse width which correlates to the observed correlated values.

13. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 1, wherein the first variable parameter comprises pulse width and the second variable parameter comprises pulse current amplitude.

14. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 13, wherein the controller is configured to attenuate pulse current amplitude over an attenuation range of reduced incrementally set pulse width values.

15. A method of administering regional anesthesia to a subject utilizing a nerve stimulation system constructed in accordance with claim 1, the target nerve being situate in the subject, the method comprising the steps of:

a) subcutaneously penetrating the subject with the administration needle,

b) noting muscular contractions of the subject responsive to stimulation of the target nerve,

c) advancing the administration needle toward the target nerve,

d) engaging the operator input to incrementally reduce the first variable parameter and, in response the controller reducing the value of the second variable parameter to maintain muscular contractions,

e) terminating step c) and step d) when a minimum value level of the first variable parameter is reached while maintaining muscular contractions, and

f) administering an anesthetic through the administration needle.

16. A nerve stimulation system configured to position an administration needle proximate a target nerve as constructed in accordance with claim 1, wherein the target nerve is situate in a subject, the pulse generator is configured to generate a pulse output waveform at a pair of output terminals, the administration needle is operatively connected to a first of the pair of output terminals, the administration needle is configured to be introduced into the subject at a location anatomically positioned for locating the target nerve, and the system further including a return current path lead operatively connected between the subject and a second of the pair of output terminals.

17. A nerve stimulation system configured to administer regional anesthesia proximate a target nerve, the stimulation system comprising:

an operator interface;

a pulse generator configured to generate a pulse output waveform at an output terminal;

a controller operatively connected to the pulse generator and the operator interface; and

an administration needle configured to administer an anesthetic, the administration needle operatively connected to the output terminal;

wherein the pulse output waveform comprises repeating cycles of three different pulse width components of equal pulse current amplitude separated by ⅓

of the waveform frequency and the operator interface is configured to input a signal to the controller to simultaneously vary the pulse current amplitude of each pulse width component.

18. A nerve stimulation system configured to administer regional anesthesia proximate a target nerve as constructed in accordance with claim 17, wherein the three different pulse width components comprise a first width component followed by two progressively smaller width components.

19. A method of programming a controller of a nerve stimulation system having a pulse generator which generates a pulse waveform output and an operator interface, the pulse waveform comprising pulses, each pulse having a pulse current amplitude and a pulse width, the controller being operatively connected to the pulse generator and to the operator interface, the method comprising the steps of:

a) operatively connecting an administration needle to the pulse generator,

b) introducing the administration needle into a subject at a location anatomically positioned for locating a target nerve to elicit stimulation of the target nerve,

c) advancing the administration needle toward the target nerve while incrementally reducing the pulse current amplitude,

d) reducing the pulse width to maintain stimulation while performing step c),

e) observing and noting values of pulse current amplitude and pulse width necessary to maintain stimulation of the target nerve while performing steps c) and d), and

f) programming the controller with a transfer function of pulse current amplitude versus pulse width which correlates to the noted values.

20. A method of programming a controller of a nerve stimulation needle in accordance with claim 19, wherein step c) is performed by linearly advancing the administration needle.