Methods and Systems for Predicting Patient Responsiveness to Subcutaneous Neuromodulation Therapy as a Treatment for Hypertension

• US 20160256115A1
• Filed: 02/29/2016
• Published: 09/08/2016
• Est. Priority Date: 03/02/2015
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Peterson, David K. L.
• Granted Patent: US 10,820,864 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

An exemplary method includes determining a variability of a plurality of measurements of a cardiovascular parameter of a patient suffering from hypertension, the plurality of measurements recorded one at a time over a predetermined time period. The method further includes comparing the determined variability with a predetermined reference value. If the comparing indicates that the determined variability is less than the predetermined reference value, the method includes designating the patient to be within a first class of patients representative of patients that are likely to be responsive to subcutaneous neuromodulation therapy as a treatment for hypertension. If the comparing indicates that the determined variability is greater than the predetermined reference value, the method includes designating the patient to be within a second class of patients representative of patients that are likely to be unresponsive to subcutaneous neuromodulation therapy as a treatment for hypertension. Corresponding systems and methods are also described.

Claims

1. A method comprising:

determining, by a therapy response prediction system, a variability of a plurality of measurements of a cardiovascular parameter of a patient suffering from hypertension, the plurality of measurements recorded one at a time over a predetermined time period;

comparing, by the therapy response prediction system, the determined variability with a predetermined reference value;

designating, by the therapy response prediction system if the comparing indicates that the determined variability is less than the predetermined reference value, the patient to be within a first class of patients, the first class of patients representative of patients that are likely to be responsive to subcutaneous neuromodulation therapy as a treatment for hypertension; and

designating, by the therapy response prediction system if the comparing indicates that the determined variability is greater than the predetermined reference value, the patient to be within a second class of patients, the second class of patients representative of patients that are likely to be unresponsive to subcutaneous neuromodulation therapy as a treatment for hypertension.

2. The method of claim 1, wherein the predetermined time period corresponds to waking hours of the patient during a single day.

3. The method of claim 2, wherein at least some of the plurality of measurements are recorded at scheduled times occurring at least twice per hour during the waking hours of the patient.

4. The method of claim 1, wherein the predetermined time period includes twenty-four consecutive hours.

5. The method of claim 4, wherein:

at least some of the plurality of measurements are recorded at scheduled times occurring at least twice per hour during waking hours of the patient within the twenty-four consecutive hours; and

at least some of the plurality of measurements are recorded at scheduled times occurring at least once per hour during sleeping hours of the patient within the twenty-four consecutive hours.

6. The method of claim 1, wherein the cardiovascular parameter of the patient is at least one of a systolic blood pressure and a diastolic blood pressure of the patient.

7. The method of claim 1, wherein:

the variability of the plurality of measurements is a standard deviation of the plurality of measurements of the cardiovascular parameter of the patient; and

the predetermined reference value represents a reference standard deviation.

8. The method of claim 1, wherein:

the variability of the plurality of measurements is an index of variability value calculated by dividing a standard deviation of the plurality of measurements of the cardiovascular parameter of the patient by a square root of an average cardiovascular parameter of the patient, the average cardiovascular parameter of the patient generated by averaging, over the predetermined time period, the plurality of measurements of the cardiovascular parameter of the patient; and

the predetermined reference value represents a reference index of variability calculated by dividing a reference standard deviation by a square root of a group-averaged cardiovascular parameter, the group-averaged cardiovascular parameter generated by averaging a plurality of average cardiovascular parameters of members of a group including a plurality of other patients suffering from hypertension.

9. The method of claim 1, wherein the determining of the variability of the plurality of measurements of the cardiovascular parameter of the patient includes receiving a value representative of the variability from a measuring device separate from the therapy response prediction system, wherein the measuring device is configured to record the plurality of measurements of the cardiovascular parameter of the patient and calculate the value of the variability.

10. The method of claim 1, wherein the determining of the variability of the plurality of measurements of the cardiovascular parameter of the patient includes:

receiving, from a measuring device separate from the therapy response prediction system and configured to record the plurality of measurements, data representative of the plurality of measurements; and

using the data representative of the plurality of measurements to calculate a value representative of the variability.

11. The method of claim 1, wherein the determining of the variability of the plurality of measurements of the cardiovascular parameter of the patient includes normalizing a value representative of the variability to account for a bias of a measuring device separate from the therapy response prediction system and used to record the plurality of measurements of the cardiovascular parameter of the patient.

12. The method of claim 1, wherein:

the designating of the patient to be within the first class of patients includes assigning, within a storage facility of the therapy response prediction system, the patient a first binary value representative of a determination by the therapy response prediction system that the patient is likely to be responsive to the subcutaneous neuromodulation therapy as a treatment for hypertension; and

the designating of the patient to be within the second class of patients includes assigning, within the storage facility of the therapy response prediction system, the patient a second binary value different than the first binary value and representative of a determination by the therapy response prediction system that the patient is likely to be unresponsive to the subcutaneous neuromodulation therapy as a treatment for hypertension.

13. The method of claim 1, further comprising:

providing, by the therapy response prediction system for use by a user of the therapy response prediction system, a graphical user interface presented on a display screen associated with the therapy response prediction system;

presenting, by the therapy response prediction system within the graphical user interface if the patient is designated to be within the first class of patients, an indication that the patient is likely to be responsive to the subcutaneous neuromodulation therapy as a treatment for hypertension; and

presenting, by the therapy response prediction system within the graphical user interface if the patient is designated to be within the second class of patients, an indication that the patient is likely to be unresponsive to the subcutaneous neuromodulation therapy as a treatment for hypertension.

14. The method of claim 1, further comprising:

automatically enabling, by the therapy response prediction system if the patient is designated to be within the first class of patients, a disabled subcutaneous neuromodulation therapy device implanted within the patient as treatment for the hypertension of the patient; and

avoiding enabling, by the therapy response prediction system if the patient is designated to be within the second class of patients, the disabled subcutaneous neuromodulation therapy device implanted within the patient as treatment for the hypertension of the patient.

15. The method of claim 1, embodied as computer-executable instructions on at least one non-transitory computer-readable medium.

16. A method comprising:

determining, by a therapy response prediction system, an index of variability of a plurality of blood pressure measurements of a patient suffering from hypertension, the plurality of blood pressure measurements recorded one at a time during waking hours of the patient during a single day, and the index of variability calculated by dividing a standard deviation of the plurality of blood pressure measurements of the patient by a square root of an average blood pressure parameter of the patient generated by averaging, over the waking hours during the single day, the plurality of blood pressure measurements of the patient;

comparing, by the therapy response prediction system, the determined index of variability with a predetermined reference index of variability calculated by dividing a reference standard deviation by a square root of a group-averaged blood pressure parameter, the group-averaged blood pressure parameter generated by averaging a plurality of average blood pressure parameters of members of a group including a plurality of other patients suffering from hypertension;

designating, by the therapy response prediction system if the comparing indicates that the determined index of variability is less than the predetermined reference index of variability, the patient to be within a first class of patients, the first class of patients composed of patients that are likely to be responsive to subcutaneous neuromodulation therapy as a treatment for hypertension; and

designating, by the therapy response prediction system if the comparing indicates that the determined index of variability is greater than the predetermined reference index of variability, the patient to be within a second class of patients, the second class of patients composed of patients that are likely to be unresponsive to subcutaneous neuromodulation therapy as a treatment for hypertension.

17. The method of claim 16, embodied as computer-executable instructions on at least one non-transitory computer-readable medium.

18. A system comprising:

at least one physical computing device that;

determines a variability of a plurality of measurements of a cardiovascular parameter of a patient suffering from hypertension, the plurality of measurements recorded one at a time over a predetermined time period;

compares the determined variability with a predetermined reference value;

designates, if the comparison indicates that the determined variability is less than the predetermined reference value, the patient to be within a first class of patients, the first class of patients representative of patients that are likely to be responsive to subcutaneous neuromodulation therapy as a treatment for hypertension; and

designates, if the comparison indicates that the determined variability is greater than the predetermined reference value, the patient to be within a second class of patients, the second class of patients representative of patients that are likely to be unresponsive to subcutaneous neuromodulation therapy as a treatment for hypertension.

19. The system of claim 18, wherein:

the variability of the plurality of measurements is a standard deviation of the plurality of measurements of the cardiovascular parameter of the patient; and

the predetermined reference value represents a reference standard deviation.

20. The system of claim 18, wherein:

the variability of the plurality of measurements is an index of variability value calculated by dividing a standard deviation of the plurality of measurements of the cardiovascular parameter of the patient by a square root of an average cardiovascular parameter of the patient, the average cardiovascular parameter of the patient generated by averaging, over the predetermined time period, the plurality of measurements of the cardiovascular parameter of the patient; and

the predetermined reference value represents a reference index of variability calculated by dividing a reference standard deviation by a square root of a group-averaged cardiovascular parameter, the group-averaged cardiovascular parameter generated by averaging a plurality of average cardiovascular parameters of members of a group including a plurality of other patients suffering from hypertension.