IP Library Granted Patent US 10,820,864
Granted Patent B2
US 10,820,864 · App. 15/057,106 · Granted Nov 3, 2020

Methods and systems for predicting patient responsiveness to subcutaneous neuromodulation therapy as a treatment for hypertension

Inventor: David K. L. Peterson (Valencia, CA)
Assignee: Valencia Technologies Corporation
A61B5/7275A61B5/021A61B5/7246A61N1/0504A61N1/36117G16H20/40G16H50/30G16H20/10
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Quick Facts
Patent No.
US 10,820,864
App. No.
15/057,106
Granted
Nov 3, 2020
Kind
B2
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 (75)

1. A method comprising:

receiving, by a processor that is included within a therapy response prediction system and that is configured to execute instructions stored in a memory of the therapy response prediction system, a first plurality of blood pressure measurements recorded over a predetermined time period by a first automatic blood pressure monitor from a first patient suffering from hypertension and a second plurality of blood pressure measurements recorded over the predetermined time period by a second automatic blood pressure monitor from a second patient suffering from hypertension;

calculating, by the processor, a first blood pressure variability value representative of a variability of the first plurality of blood pressure measurements and a second blood pressure variability value representative of a variability of the second plurality of blood pressure measurements;

normalizing, by the processor, the first and second blood pressure variability values to account for different biases of the first and second automatic blood pressure monitors with respect to one another;

generating, by the processor, a predetermined reference value that is a group-averaged blood pressure variability parameter generated by averaging a plurality of blood pressure variability values that includes the first and second normalized blood pressure variability values;

comparing, by the processor, each of the first and second normalized blood pressure variability values with the predetermined reference value;

designating, by the processor in response to the comparing indicating that the first normalized blood pressure variability value is less than the predetermined reference value, the first 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;

designating, by the processor in response to the comparing indicating that the second normalized blood pressure variability value is greater than the predetermined reference value, the second 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;

providing, by the processor in response to the first patient being designated to be within the first class of patients, neuromodulation therapy to treat the hypertension of the first patient by automatically enabling a disabled subcutaneous neuromodulation therapy device implanted within the first patient; and

avoiding providing, by the processor in response to the second patient being designated to be within the second class of patients, the neuromodulation therapy to treat the hypertension of the second patient by abstaining from automatically enabling a disabled subcutaneous neuromodulation therapy device implanted within the second patient.

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 first plurality of blood pressure 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 first plurality of blood pressure 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 first plurality of blood pressure 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 particular type of blood pressure measurements that the first and second automatic blood pressure monitors are configured to perform includes at least one of a systolic blood pressure and a diastolic blood pressure of the patient.

7. The method of claim 1 , wherein:

the first blood pressure variability value is a standard deviation of the first plurality of blood pressure measurements of the patient; and

the predetermined reference value represents a reference standard deviation.

8. The method of claim 1 , wherein:

the first blood pressure variability value of blood pressure measurements is an index of variability value calculated by dividing a standard deviation of the first plurality of blood pressure measurements of the first patient by a square root of an average blood pressure of the first patient, the average blood pressure of the first patient generated by averaging, over the predetermined time period, the first plurality of blood pressure measurements of the first 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 blood pressure of a group including the first and second patients.

9. The method of claim 1 , wherein:

the first automatic blood pressure monitor is separate from the therapy response prediction system;

the first automatic blood pressure monitor is configured to record the first plurality of blood pressure measurements of the first patient and calculate the first blood pressure variability value; and

the determining of the first blood pressure variability value includes receiving the first blood pressure variability value from the first automatic blood pressure monitor.

10. The method of claim 1 , wherein:

the first automatic blood pressure monitor is separate from the therapy response prediction system; and

the determining of the first blood pressure variability value includes

receiving, from the first automatic blood pressure monitor, data representative of the first plurality of blood pressure measurements, and

using the data representative of the first plurality of blood pressure measurements to calculate the first blood pressure variability value.

11. The method of claim 1 , wherein:

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

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

12. The method of claim 1 , further comprising:

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

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

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

14. A method comprising:

receiving, by a processor that is included within a therapy response prediction system and that is configured to execute instructions stored in a memory of the therapy response prediction system, a first plurality of blood pressure measurements recorded over a predetermined time period by a first automatic blood pressure monitor from a first patient suffering from hypertension and a second plurality of blood pressure measurements recorded over the predetermined time period by a second automatic blood pressure monitor from a second patient suffering from hypertension;

calculating, by the processor, a first index of variability of a first plurality of blood pressure measurements and a second index of variability of the second plurality of blood pressure measurements, the first index of variability calculated by dividing a standard deviation of the first plurality of blood pressure measurements of the first patient by a square root of an average blood pressure parameter of the first patient generated by averaging, over the waking hours during the single day, the first plurality of blood pressure measurements of the first patient;

normalizing, by the processor, the first and second indices of variability to account for different biases of the first and second automatic blood pressure monitors with respect to one another;

generating, by the processor, a predetermined reference index of variability that is 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 the first and second patients;

comparing, by the processor, each of the first and second normalized indices of variability with the predetermined reference index of variability;

designating, by the processor in response to the comparing indicating that the first normalized index of variability is less than the predetermined reference index of variability, the first 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;

designating, by the processor in response to the comparing indicating that the second normalized index of variability is greater than the predetermined reference index of variability, the second 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;

providing, by the processor in response to the first patient being designated to be within the first class of patients, neuromodulation therapy to treat the hypertension of the first patient by automatically enabling a disabled subcutaneous neuromodulation therapy device implanted within the first patient; and

avoiding providing, by the processor in response to the second patient being designated to be within the second class of patients, the neuromodulation therapy to treat the hypertension of the second patient by abstaining from automatically enabling a disabled subcutaneous neuromodulation therapy device implanted within the second patient.

15. The method of claim 14 , embodied as computer-executable instructions on at least one non-transitory computer-readable medium.

16. A system comprising:

a processor; and

a memory communicatively coupled with the processor and storing instructions that, when executed by the processor, direct the processor to:

receive a first plurality of blood pressure measurements recorded over a predetermined time period by a first automatic blood pressure monitor from a first patient suffering from hypertension and a second plurality of blood pressure measurements recorded over the predetermined time period by a second automatic blood pressure monitor from a second patient suffering from hypertension;

calculate a first blood pressure variability value representative of a variability of the first plurality of blood pressure measurements and a second blood pressure variability value representative of a variability of the second plurality of blood pressure measurements;

normalize the first and second blood pressure variability values to account for different biases of the first and second automatic blood pressure monitors with respect to one another;

compare each of the first and second normalized blood pressure variability values with the predetermined reference value;

designate, in response to the comparison indicating that the first normalized blood pressure variability value is less than the predetermined reference value, the first 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;

designate, in response to the comparison indicating that the second normalized blood pressure variability value is greater than the predetermined reference value, the second 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;

provide, in response to the first patient being designated to be within the first class of patients, neuromodulation therapy to treat the hypertension of the first patient by automatically enabling a disabled subcutaneous neuromodulation therapy device implanted within the first patient; and

avoid providing, in response to the second patient being designated to be within the second class of patients, the neuromodulation therapy to treat the hypertension of the second patient by abstaining from automatically enabling a disabled subcutaneous neuromodulation therapy device implanted within the second patient.

17. The system of claim 16 , wherein:

the first blood pressure variability value is a standard deviation of the first plurality of blood pressure measurements of the patient; and

the predetermined reference value represents a reference standard deviation.

18. The system of claim 16 , wherein:

the first blood pressure variability value is an index of variability value calculated by dividing a standard deviation of the first plurality of blood pressure measurements of the first patient by a square root of an average blood pressure of the first patient, the average blood pressure of the first patient generated by averaging, over the predetermined time period, the first plurality of blood pressure measurements of the first 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 blood pressure of a group including the first and second patients.

19. The system of claim 16 , wherein:

the predetermined time period corresponds to waking hours of the patient during a single day; and

at least some of the first plurality of blood pressure measurements are recorded at scheduled times occurring at least twice per hour during the waking hours of the patient.

20. The system of claim 16 , wherein:

the first automatic blood pressure monitor is separate from the system;

the first automatic blood pressure monitor is configured to record the first plurality of blood pressure measurements of the first patient and calculate the first blood pressure variability value; and

the determining of the first blood pressure variability value includes receiving the first blood pressure variability value from the first automatic blood pressure monitor.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded May 6, 2026
From: MEDTRONIC, INC.
To: VALENCIA BIOSCIENCE, INC.
Reel/Frame 075721/0223 →
SECURITY INTEREST Recorded Oct 27, 2023
From: VALENCIA BIOSCIENCE, INC.
To: MEDTRONIC, INC.
Reel/Frame 065382/0738 →
SECURITY INTEREST Recorded Aug 4, 2021
From: VALENCIA BIOSCIENCE, INC.
To: MEDTRONIC, INC.
Reel/Frame 057088/0352 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 3, 2020
From: VALENCIA TECHNOLOGIES CORPORATION
To: VALENCIA BIOSCIENCE, INC.
Reel/Frame 053684/0656 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 29, 2016
From: PETERSON, DAVID K. L.
To: VALENCIA TECHNOLOGIES CORPORATION
Reel/Frame 037856/0298 →
Continuity (2)
Provisional Application 62127068 · Mar 2, 2015
Related Publication 20160256115A1 · Sep 8, 2016
Cited By (1)
US 12,290,345