US 11,911,177 B2
Determining an efficacy of a treatment program
Ekaterina M. Ippolito, Shoreview, MN (US); Shantanu Sarkar, Roseville, MN (US); Eduardo N. Warman, Maple Grove, MN (US); and Joel R. Lauer, Clearwater, MN (US)
Assigned to Medtronic, Inc., Minneapolis, MN (US)
Filed by Medtronic, Inc., Minneapolis, MN (US)
Filed on Jul. 1, 2020, as Appl. No. 16/918,555.
Prior Publication US 2022/0000421 A1, Jan. 6, 2022
Int. Cl. A61B 5/00 (2006.01); G16H 40/60 (2018.01); A61B 5/0205 (2006.01); A61B 5/361 (2021.01); A61B 5/024 (2006.01); A61B 5/053 (2021.01); A61B 5/08 (2006.01)
CPC A61B 5/4848 (2013.01) [A61B 5/0205 (2013.01); A61B 5/4842 (2013.01); A61B 5/686 (2013.01); A61B 5/7275 (2013.01); G16H 40/60 (2018.01); A61B 5/024 (2013.01); A61B 5/053 (2013.01); A61B 5/0816 (2013.01); A61B 5/361 (2021.01)] 19 Claims
OG exemplary drawing
 
1. A medical device system comprising:
an implantable medical device comprising one or more sensors, wherein the implantable medical device is configured to be implanted underneath a skin of a patient so that the implantable medical device and the one or more sensors occupy a desired orientation over a period of time greater than seven days, wherein a length of the implantable medical device is greater than a depth of the implantable medical device and a width of the implantable medical device is greater than the depth of the implantable medical device so that the implantable medical device and the one or more sensors are configured to remain in the desired orientation following implantation throughout the period of time greater than seven days,
wherein the one or more sensors comprise:
sensing circuitry; and
a set of electrodes located on a first major surface of the implantable medical device opposite a second major surface of the implantable medical device, wherein the first major surface faces target tissue of the patient when the implantable medical device occupies the desired orientation over the period of time greater than seven days, and
wherein the sensing circuitry is configured to continuously generate, based on a physiological signal sensed from the target tissue via the set of electrodes, an electrical signal that indicates a parameter of the patient over the period of time greater than seven days; and
processing circuitry configured to:
receive data indicative of a user selection of a reference time indicating a start of a treatment;
determine a plurality of parameter values of the parameter based on a portion of the electrical signal corresponding to a time window including the reference time, wherein each parameter value of the plurality of parameter values represents a measurement of the parameter for a respective time interval during the time window;
identify, based on a first set of parameter values of the plurality of parameter values occurring before the reference time, a reference parameter value;
identify a set of difference values, wherein each difference value of the set of difference values represents a difference between the respective parameter value of a second set of parameter values and the reference parameter value, wherein the second set of parameter values occur after the reference time;
determine a sum of the set of difference values;
determine a delta value which represents a difference between the reference parameter value and a target parameter value;
calculate a parameter change value by determining a ratio of the sum of the set of difference values to the delta value;
determine, based on the parameter change value, whether an improvement or a worsening of the patient has occurred responsive to the treatment; and
generate information indicating whether an improvement or a worsening of the patient has occurred responsive to the treatment.
 
13. A method for controlling operation of a medical device system comprising:
generating, continuously by sensing circuitry of one or more sensors of an implantable medical device based on a physiological signal sensed from target tissue of a patient via a set of electrodes of the one or more sensors, an electrical signal that indicates a parameter of the patient over a period of time greater than seven days, wherein the implantable medical device is configured to be implanted underneath a skin of the patient so that the implantable medical device and the one or more sensors occupy a desired orientation over the period of time greater than seven days, wherein a length of the implantable medical device is greater than a depth of the implantable medical device and a width of the implantable medical device is greater than the depth of the implantable medical device so that the implantable medical device and the one or more sensors are configured to remain in the desired orientation following implantation throughout the period of time greater than seven days, wherein the set of electrodes are located on a first major surface of the implantable medical device opposite a second major surface of the implantable medical device, wherein the first major surface faces the target tissue of the patient when the implantable medical device occupies the desired orientation over the period of time greater than seven days;
receiving, by processing circuitry of the medical device system, data indicative of a user selection of a reference time indicating a start of a treatment;
determining, by the processing circuitry, a plurality of parameter values of the parameter based on a portion of the electrical signal corresponding to a time window including the reference time, wherein each parameter value of the plurality of parameter values represents a measurement of the parameter for a respective time interval during the time window;
identifying, by the processing circuitry based on a first set of parameter values of the plurality of parameter values occurring before the reference time, a reference parameter value;
identifying, by the processing circuitry, a set of difference values, wherein each difference value of the set of difference values represents a difference between the respective parameter value of a second set of parameter values and the reference parameter value, wherein the second set of parameter values occur after the reference time;
determining, by the processing circuitry, a sum of the set of difference values;
determining, by the processing circuitry, a delta value which represents a difference between the reference parameter value and a target parameter value;
calculating, by the processing circuitry, a parameter change value by determining a ratio of the sum of the set of difference values to the delta value;
determining, by the processing circuitry based on the parameter change value, whether an improvement or a worsening of the patient has occurred responsive to the treatment; and
generating, by the processing circuitry, information indicating whether an improvement or a worsening of the patient has occurred responsive to the treatment.
 
16. A non-transitory computer-readable medium comprising instructions for causing one or more processors to:
control sensing circuitry of one or more sensors of an implantable medical device to generate, based on a physiological signal sensed from target tissue of a patient via a set of electrodes of the one or more sensors, an electrical signal that indicates a parameter of the patient over a period of time greater than seven days, wherein the implantable medical device is configured to be implanted underneath a skin of the patient so that the implantable medical device and the one or more sensors occupy a desired orientation over the period of time greater than seven days, wherein a length of the implantable medical device is greater than a depth of the implantable medical device and a width of the implantable medical device is greater than the depth of the implantable medical device so that the implantable medical device and the one or more sensors are configured to remain in the desired orientation following implantation throughout the period of time greater than seven days, wherein the set of electrodes are located on a first major surface of the implantable medical device opposite a second major surface of the implantable medical device, wherein the first major surface faces the target tissue of the patient when the implantable medical device occupies the desired orientation over the period of time greater than seven days;
receive data indicative of a user selection of a reference time;
determine a plurality of parameter values of the parameter based on a portion of the electrical signal corresponding to a time window including the reference time, wherein each parameter value of the plurality of parameter values represents a measurement of the parameter for a respective time interval during the time window;
identify, based on a first set of parameter values of the plurality of parameter values occurring before the reference time, a reference parameter value;
identify a set of difference values, wherein each difference value of the set of difference values represents a difference between the respective parameter value of a second set of parameter values and the reference parameter value, wherein the second set of parameter values occur after the reference time;
determine a sum of the set of difference values;
determine a delta value which represents a difference between the reference parameter value and a target parameter value;
calculate a parameter change value by determining a ratio of the sum of the set of difference values to the delta value;
determine, based on the parameter change value, whether an improvement or a worsening of the patient has occurred responsive to a treatment administered beginning at the reference time; and
generate information indicating whether an improvement or a worsening of the patient has occurred responsive to the treatment.