Patient interactive neurostimulation system and method

• US 6,308,102 B1
• Filed: 09/29/1999
• Issued: 10/23/2001
• Est. Priority Date: 09/29/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Stimsoft, Inc.
• Inventors: Sieracki, Jeffrey Mark, North, Richard Boydston, Fowler, Kim Randal
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/408,129
• Time in Patent Office: 755 Days
• Field of Search: 607/43, 607/46, 607/48, 607/55, 607/56, 607/57, 607/58, 607/59, 607/63, 607/64, 607/117, 607/118, 607/137
• US Class Current: 607/59
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

The present invention is a fully automated computer controlled system for adjustment of neurostimulation implants used in pain therapy and in treating neurological dysfunction which includes a patient interactive computer, and a universal transmitter interface integrally embedded in the patient interactive computer, or built into the antenna which is capable of stimulating any type of implanted neurostimulation devices by imitating any of the proprietary programming codes. The patient interacts with the system through the patient interactive computer (containing a unique software) which provides for consistency check of the data entered by the patient, deleting the entered data if the consistency check was not satisfactory, and requesting the patient to re-enter the data.

Claims

1. In a patient interactive neurostimulation system, including processing means accepting the patient entered data and patient interactive means for direct interaction between the patient and said processing means, said patient interactive means being used for patient data entry, wherein an improvement comprises:

means for presetting consistency boundaries for data entered by the patient into said processing means by means of said patient interactive means,

checking means for verifying whether said entered data falls within said consistency boundaries, and

means for repeating said data entry by said patient when said entered data fails to fall within said consistency boundaries.

2. The patient interactive neurostimulation system of claim 1, wherein said patient interactive means include a display means, the patient'"'"'s body being displayed on said display means, and wherein said improvement further comprises:

means for sequentially entering previous and successive measures of the identical nature with reference to outline of the patient'"'"'s body displayed on said display means of said patient interactive means, regions of the patient body corresponding to said previous measures being displayed simultaneously with the regions of the patient'"'"'s body corresponding to said successive measures.

3. The patient interactive neurostimulation system of claim 2, wherein said measures of identical nature include either one of pain severity and stimulation level.

4. The patient interactive neurostimulation system of claim 1, further comprising:

a plurality of neurological stimulator devices adapted to be implanted in the body of a patient, said neurological stimulator devices being adapted for receiving a specific one of a plurality of predetermined programming codes and responding thereto to provide electrical stimulation to nervous tissue according to said specific one predetermined programming code;

a patient interactive computer having a display means and adapted to request the patient to perform a specified action; and

indication means operated by the patient and adapted to generate indicia on said display means of said patient-interactive computer in response to said action of the patient, said patient-interactive computer requesting said action by displaying a request for said action on said display means of said patient-interactive computer;

wherein said improvement further comprises;

a transmitter interface unit including controlling means for imitating either of said plurality of said predetermined programming codes, and driving said transmitter interface unit to transmit said specific one predetermined code towards said neurological stimulator device.

5. The patient interactive neurostimulation system of claim 4, wherein said transmitter interface unit is integrally embedded within said patient-interactive computer.

6. The patient-interactive neurostimulation system of claim 4, wherein each of said neurological stimulation devices includes at least a pair of electrodes and an RF (radio frequency) receiver;

an antenna being secured to the body of the patient;

said antenna being operatively coupled to said neurological stimulation devices, and

wherein said transmitter interface unit is integrally embedded within said antenna.

7. The patient-interactive neurostimulation system of claim 4, wherein said improvement further comprises defining means within said patient-interactive computer for defining which one of said plurality of said specific predetermined programming codes has to be generated within said transmitter interface unit;

said transmitter interface unit further including;

a control interface unit communicating with said patient-interactive computer through a communication channel to transmit data defined by said defining means;

a data memory unit adapted to store a plurality of parameters for said plurality of said specific predetermined programming codes, said data memory unit interfacing with said control interface unit and exchanging data therewith;

a direct digital synthesizer interfacing with said control interface unit and receiving data therefrom;

a programmable clock unit interfacing with said control interface unit and receiving data therefrom, said programmable clock unit clocking said direct digital synthesizer;

a programmable gain/amplitude control unit interfacing with said control interface unit and receiving data therefrom, said programmable gain/amplitude control unit feeding data to said direct digital synthesizer; and

a radio frequency amplifier coupled to an output of said direct digital synthesizer and amplifying an output signal received therefrom, said amplified output signal being transmitted to said neurological stimulation devices.

8. The patient-interactive neurostimulation system of claim 4, further including screen graphics displayed on said display means and a screen worded message to the patient corresponding to said screen graphics displayed substantially simultaneously with said screen graphics on said display means of said patient-interactive computer, said screen worded message describing to the patient an action expected from the same to operate said indication means.

9. The patient-interactive neurostimulation system of claim 8, wherein said screen graphics includes images of a human'"'"'s body, and wherein said screen worded message requests the patient to outline, by means of said indication means, an area of the pain being experienced to be aligned with respective areas of said images of the human'"'"'s body.

10. The patient-interactive neurostimulation system of claim 9, wherein said screen worded message further includes a request to the patient to outline, by means of said indication means, a topography of paresthesias in response to the electrical stimulation by said specific predetermined programming code transmitted by said transmitter interface unit towards said neurological stimulator devices.

11. The patient interactive neurostimulation system of claim 10, wherein the area of the pain has pixels, and wherein said improvement further comprises means for comparing pixel by pixel the area of the pain being experienced to the topography of paresthesias.

12. The patient-interactive neurostimulation system of claim 10, wherein said screen graphics further includes a rating bar, and wherein said screen worded message further includes a request to the patient to indicate on said rating bar, by means of said indication means, a degree of overlap of said area of the pain and said topography of paresthesias.

13. The patient-interactive neurostimulation system of claim 8, wherein said screen graphics includes a stimulation amplitude adjustment screen for threshold determination, said stimulation amplitude adjustment screen including an amplitude adjustment bar, and said screen worded message requesting the patient to increase the amplitude by sliding said indication means along said amplitude adjustment bar, until the patient starts to feel the stimulation sensation.

14. The patient-interactive neurostimulation system of claim 13, wherein said threshold includes either of bilateral threshold, “

discomfort”

threshold, perceptual threshold, preferred level of pain relief threshold, area of interest threshold, and motor threshold.

15. The patient-interactive neurostimulation system of claim 4, wherein said patient interactive computer includes a pen-top computer.

16. The patient-interactive neurological system of claim 4, wherein said indication means includes stylus.

17. The patient-interactive neurostimulation system of claim 4, further including a physician'"'"'s computer telemetrically communicating with said patient-interactive computer, a plurality of optimization protocols being stored in said physician'"'"'s computer, each of said optimization protocols for defining a predetermined optimization session.

18. The patient-interactive neurostimulation system of claim 17, wherein data corresponding to responses entered by the patient into said patient-interactive computer are archived in said physician'"'"'s computer.

19. The patient-interactive neurostimulation system of claim 4, further including printing means in communication with said patient interactive computer.

20. The patient-interactive neurostimulation system of claim 4, further including means for providing communication with a remote computer server.

21. The patient-interactive neurostimulation system of claim 4, wherein responses of the patient are entered into said patient-interactive computer, further including optimization means for processing data corresponding to said responses entered by the patient into said patient-interactive computer, and generating a report containing data corresponding to the optimal combination of stimulation settings for the best pain relief.

22. The patient interactive neurostimulation system of claim 1, wherein said improvement further comprises:

adaptive means for studying consistency behavior of the patient and avoiding verification of the consistency boundaries if the patient'"'"'s behavior is consistent with reasonable expectations.

23. In a method of controlling neurostimulation in a neurological stimulation system including a patient interactive computer having a display means, and a stylus operated by the patient and adapted to enter data by generating indicia on said display means of said patient-interactive computer in response to messages displayed on said display means, wherein an improvement comprises the steps of:

pre-setting consistency boundaries for data entered by the patient,

verifying whether the data entered fall within said consistency boundaries, and

deleting said data and repeating said data entry by said patient when said entered data does not fall within said consistency boundaries.

24. The method of claim 23, wherein said improvement further comprises the steps of:

studying the consistency behavior of the patient, and

avoiding the verification of the consistency boundaries if the patient'"'"'s behavior is consistent with reasonable expectations.

25. The method of claim 23, further comprising the steps of:

(a) providing in said neurological stimulation system a plurality of neurological stimulator devices implanted in the body of a patient, said neurological stimulator devices being responsive to a specific predetermined one of a plurality of programming codes, and providing electrical stimulation to nervous tissue in response to said specific predetermined programming code; and

(b) memory means for storing a plurality of optimization protocols, each said optimization protocol corresponding to a predetermined stimulus setting;

said improvement further comprising the steps of;

providing a transmitter interface unit, said transmitter interface unit being adapted to imitate any of said plurality of programming codes; and

imitating a desired one of said plurality of programming codes.

26. The method of claim 25, further comprising the steps of:

(a) setting one of said plurality of optimization protocols and transmitting data corresponding to said selected optimization protocol to said patientinteractive computer, thereby setting the same to said predetermined stimulus setting;

(b) displaying on said display means of said patient-interactive computer simultaneously a screen graphics and a screen worded message, both corresponding to said selected optimization protocol, said screen worded message describing to the patient an action expected from the same to operate said stylus, thereby entering into said patient-interactive computer requested data for further processing; and

(c) processing said data for optimization of the stimulus setting for the most effective pain relief.

27. The method of claim 26, wherein said improvement further comprises multi-level body-region entry, comprising the steps of:

sequentially entering previous and successive measures of the identical nature with reference to the screen graphics, including the patient'"'"'s body displayed on said display means of said patient interactive computer, the regions of the patient'"'"'s body corresponding to said previous measures being displayed simultaneously with the regions of the patient'"'"'s body corresponding to said successive measures.

28. The method of claim 27, wherein said measures of identical nature include either of pain severity and stimulation level.

29. The method of claim 26, further including the steps of:

confirmation of said requested data entered into said patient-interactive computer by the patient; and

re-entering said requested data into said patient-interactive computer, if needed.

30. The method of claim 26, wherein said optimization protocols include either of the following steps in a predetermined combination thereof:

adjusting stimulation level by a patient controlled amplitude adjustment procedure to meet amplitude thresholds;

entering an area of the pain experienced overlapped with an image of a human'"'"'s body displayed on said display means of said patient-interactive computer;

entering a topography of paresthesias in response to the electrical stimulation overlapped with an image of the human'"'"'s body displayed on said display means of said patient-interactive computer;

entering data corresponding to a degree of overlapping of said area of the pain experienced and said topography of paresthesias;

establishing a pause between switching from one protocol to another; and

determining multiple thresholds.

31. The method of claim 30, further comprising the steps of:

in said step of the patient controlled amplitude adjustment, displaying on said display means of said patient interactive computer a bar outline having an indicia thereon indicating a current amplitude level, and

adjusting the amplitude in either of the following fashions;

(a) placing said stylus in close juxtaposition with said indicia on said bar outline, and moving said stylus in one of two opposite directions along said bar outline, thereby moving said indicia and thereby increasing or decreasing the amplitude, said stylus moving with a rate slower than a predetermined maximum rate of amplitude adjustment;

(b) placing said stylus within said bar outline at a distance from said indicia, thereby causing said indicia to move towards said stylus at a predetermined safe rate of amplitude adjustment, a rate of increasing the amplitude being slower than a rate of decreasing the same; and

(c) providing on said display means of said patient-interactive computer, external control means for changing the position of said indicia on said bar outline, said external control means being displayed adjacent to said bar outline, and operating said external control means by means of said stylus.

32. The method of claim 30, further comprising the steps of:

in said step of the patient controlled amplitude adjustment, varying the amplitude above and below an estimated threshold; and

displaying on said display means of said patient-interactive computer the screen worded message requesting the patient to verify the presence or absence of stimulation sensation.

33. The method of claim 30, wherein in the step of establishing the pause between said optimization protocols, the patient determines the pause time allowing stimulation sensations established during one of said optimization protocols fading before switching to another of said optimization protocols.

34. The method of claim 30, further comprising the steps of:

testing different thresholds at identical settings in increasing order starting with the lowest possible threshold.

35. The method of claim 30, further comprising the steps of:

in said step of determination of multiple thresholds, determining “

discomfort”

amplitude threshold, and decreasing the amplitude of stimulation by the patient below said “

discomfort”

amplitude threshold once the same has been met.

36. The method of claim 30, wherein said improvement further includes the steps of:

displaying on said display means of said patient interactive computer a request for the patient to redo said step of determination of said multiple thresholds once a respective one of said multiple thresholds fails to be consistent with an expected threshold.

37. The method of claim 30, wherein said improvement further includes the step of:

displaying on said display means of said patient interactive computer a request for the patient to re-entry the topography of paresthesias when said entry of the same fails to comply with expected reasonable data.