PRESCRIPTION PAD FOR TREATMENT OF INFLAMMATORY DISORDERS

• US 20110054569A1
• Filed: 09/01/2010
• Published: 03/03/2011
• Est. Priority Date: 09/01/2009
• Status: Abandoned Application

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: ZITNIK, Ralph J., Faltys, Michael A.
• Application Number:
  US12/874,171
• Publication Number:
  US 20110054569A1
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Described herein are devices, including interface modules or prescription pads, and systems including these devices and methods of using them, for treating inflammation or inflammatory disorders, and particularly for interfacing with a user desiring to prescribe treatment of an inflammatory disorder using an implanted stimulator.

Claims

1. An interface module for translating a prescribed treatment dosage for a patient into neurostimulation parameters tailored to the patient for treatment of inflammation using an implanted neurostimulator to modulate the inflammatory reflex without substantially affecting the cardiac system, the interface module comprising:

an input configured to receive or modify a dosage input comprising a prescribed treatment dosage for the patient;

a converter configured to convert the dosage input into patient treatment regime parameters comprising a current or voltage intensity, a pulse width, a stimulation frequency, an on-time, and an off-time; and

an output configured to transmit the treatment regime parameters for receipt by an implanted neurostimulator.

2. The interface module of claim 1, wherein the patient treatment regime includes stimulation temporal characteristics configured to minimize the effects of the stimulation on the patient'"'"'s cardiac system.

3. The interface module of claim 1, wherein the interface module is a prescription pad.

4. The interface module of claim 1, wherein the converter comprises a processor configured to receive the dosage input and to execute conversion logic to determine the patient treatment regime parameters.

5. The interface module of claim 1, wherein the converter is configured to receive feedback information from the patient and to apply the feedback information to determine the patient treatment regime parameters.

6. The interface module of claim 1, wherein the input comprises a touch screen, a keypad, or a tracking device.

7. The interface module of claim 1, wherein the input is further configured to receive patient information selected from the group consisting of:

age;

weight;

height;

implant identification number;

parameters of relevant clinical disease activity including signs and symptoms;

clinical assessment indicators of disease remission or flare;

clinical laboratory values signifying disease remission or flare;

surrogate biomarkers from blood, biopsy or other tissue sources;

derived indices of systemic inflammation; and

heart rate variability.

8. The interface module of claim 1, wherein the converter is configured to set safety limits for the treatment regime parameters specific to the patient, further wherein the treatment regime parameters are constrained to be within the safety limits.

9. The interface module of claim 1, wherein the treatment regime parameters specified by the converter comprise daily or weekly treatment times.

10. The interface module of claim 1, where the treatment regime parameters are configured to indicate that the parameters vary over the course of days, weeks, or months, increasing or decreasing stimulation level.

11. An interface module for translating a prescribed treatment dosage for a patient into neurostimulation parameters tailored to the patient for treatment of inflammation using an implanted neurostimulator to modulate the inflammatory reflex, the interface module comprising:

an input configured to receive or modify a dosage input comprising a prescribed treatment dosage for the patient, further configured to receive patient-specific data input;

a converter configured to convert the dosage input and patient-specific data input into patient-specific patient treatment regime parameters comprising a current or voltage intensity, a pulse width, a stimulation frequency, an on-time, and an off-time; and

an output configured to transmit the treatment regime parameters for receipt by an implanted neurostimulator.

12. A system for controlling the administration of electrical stimulation to treat inflammation from an implanted stimulator, the system comprising:

an electrical prescription pad, the prescription pad comprising

an input configured to receive or modify a prescribed treatment dosage;

a converter configured to convert the dosage input into treatment regime parameters comprising a current or voltage intensity, a pulse width, a stimulation frequency, an on-time, and an off-time; and

an external controller configured to receive a treatment regime from the electrical prescription pad and to control an implanted controller.

13. The system of claim 12, further comprising a charger configured to charge a battery in the implanted stimulator.

14. The system of claim 12, wherein the prescription pad further comprises an output configured to transmit the treatment regime to the external controller.

15. The system of claim 12, wherein the dosage input comprises a touch screen, a keypad, or a tracking device.

16. The system of claim 12, wherein the prescription-pad is configured to receive patient information selected from the group consisting of:

age, weight, height, implant identification number.

17. The system of claim 12, wherein the converter is further configured to receive patient feedback information.

18. The system of claim 12, wherein the converter is configured to receive objective patient feedback information from external tests or implanted sensors and recorders.

19. The system of claim 12, wherein the converter is configured to set safety limits for the treatment regime parameters specific to a patient, further wherein the treatment regime parameters are constrained to be within the safety limits.

20. The system of claim 12, wherein the treatment regime parameters specified by the converter comprise daily treatment times.

21. The system of claim 12, wherein the prescription pad is further configured to indicate battery charging requirements for the implant.

22. A method of prescribing the treatment of inflammation in a patient by stimulation of the inflammatory reflex from an implanted stimulator, the method comprising:

entering a patient'"'"'s identity into the electronic prescription pad;

entering a patient'"'"'s treatment prescription into an electronic prescription pad;

converting the treatment prescription into a specific treatment regime for that patient, wherein the specific treatment regime comprises a current or voltage intensity, a pulse width, a stimulation frequency, an on-time, and an off-time; and

transmitting the specific treatment regime to a controller configured to control operation of an electrical stimulator implanted in the patient.

23. The method of claim 22, further comprising entering feedback information from the patient into the prescription pad, wherein the feedback information is used to convert the treatment prescription into the specific treatment regime.

24. The method of claim 23, wherein the feedback comprises patient reported feedback, biomarker feedback, electrical nerve activity feedback.

25. The method of claim 23, wherein the feedback consists of at least lone of:

evoked compound action potentials;

diagnostic imaging techniques;

ECG;

EMG;

EEG;

PET scan data; and

fMRI data.

26. The method of claim 22, further comprising presenting a proposed treatment regime, allowing a user to modify the proposed treatment regime, and using the proposed treatment regime to determine the specific treatment regime.

27. The method of claim 22, wherein the step of entering the patient'"'"'s treatment regime comprises entering a dosage pattern with a specific energy in microcolumbs per minute on repeated schedule.

28. The method of claim 22, wherein the step of entering the patient'"'"'s identity comprises determining an identification number identifying the implanted stimulator that is correlated with patient identity.

29. The method of claim 22, further comprising entering the patient'"'"'s diagnosis or medical history into the electronic prescription pad.