Medical system for seamless therapy adjustment

Abstract

Methods and systems for seamless adjustment of treatment are disclosed. A determination is made as to whether to intervene with a patient's treatment. Implanted device memory data is acquired over a pre-specified time period. Risk status is determined from the device memory data. Another external device memory data is acquired over a pre-specified time period. A determination is made as to whether to adjust treatment of the patient in response to the risk status, the data acquired from the implanted device memory and the external device memory data.

1 . A system for determining whether to intervene with a patient's treatment, the system comprising:
 an implantable device having a memory;   an implantable sensor;   an implantable processor;   an external device;   sensing means for sensing data through the implanted sensor;   the implanted processor configured to compare the data against a threshold stored in the memory of the implanted device to determine whether the data is considered to be indicative of a heart failure (HF) worsening episode occurrence based on a result of the comparison;   storing means for storing a determined occurrence in the memory of the implanted device;   transmitting means for transmitting the occurrence to the external device;   processing means for determining a risk status from the occurrence and any other applicable data using the external device;   means for acquiring additional data, the additional data being one of weight, symptoms, and blood pressure; and   the external device configured to automatically determine whether to adjust the patient's treatment plan comprising a set of pharmaceutical physician prescriptions based on the risk status, the data acquired from the implanted device memory and the one or more other external devices   the external device further configured to signal a medication dispenser to dispense a correct medication in response to determining to adjust the patient's treatment plan.   
     
     
         2 . The system of  claim 1  wherein the additional data is acquired from the external device or one or more other external devices. 
     
     
         3 . The system of  claim 2  wherein the additional data related to the blood pressure is acquired from the implantable processor, another implantable processor associated with another implantable device, and a wireless pulmonary artery sensor. 
     
     
         4 . The system of  claim 2  wherein the additional data related to the blood pressure is acquired from the external device or one or more external devices. 
     
     
         5 . A system of  claim 1  wherein the implanted sensor is mechanically and electrically connected to the implanted device. 
     
     
         6 . A system of  claim 1  wherein the implanted sensor is not mechanically connected to the implanted device. 
     
     
         7 . A system according to  claim 1  further comprising:
 storing means for storing a treatment plan into a memory of the external device, the treatment plan comprising a first round of medication and a second round of medication. 
 
     
     
         8 . A system according to  claim 6  wherein the treatment plan comprises delivery of a prescribed medication, the prescribed medication adjusted without directly communicating with the patient's physician any time after storing the treatment plan into memory. 
     
     
         9 . A system of  claim 1 , further comprising:
 displaying means for displaying the adjusted treatment on a graphical user interface in response to determining that the patient's treatment requires adjustment.   
     
     
         10 . A system of  claim 1 , further comprising:
 means for acquiring raw impedance data after a prescribed period of time in response to adjusting the treatment of the patient; and   means for using the raw impedance data to determine whether the patient is improving in response to the treatment.   
     
     
         11 . A system of  claim 1 , further comprising:
 processing means for determining whether the raw impedance data, acquired from the implanted device memory, crosses a threshold; and   in response to determining whether the raw impedance data crosses the threshold, determining whether the raw impedance data is considered a heart failure exacerbation.   
     
     
         12 . A system of  claim 1 , wherein the raw impedance data that is a non-heart failure exacerbation does not require an intervention by the healthcare system. 
     
     
         13 . A system of  claim 12 , wherein the non-heart failure exacerbation does not cause an adjustment to treatment. 
     
     
         14 . A system of  claim 12 , wherein the non-heart failure exacerbation triggers a notification to medical personnel. 
     
     
         15 . A system of  claim 12 , wherein the non-heart failure exacerbation does not trigger an intervention. 
     
     
         16 . A system of  claim 12 , wherein the raw impedance data that is a heart failure exacerbation that requires an intervention by the healthcare system. 
     
     
         17 . A system of  claim 8 , further comprising:
 processing means for determining whether to terminate adjusted treatment in response to data monitored after treatment was adjusted.   
     
     
         18 . A system of  claim 17 , wherein termination of adjusted treatment is based upon one of patient blood pressure, and symptoms. 
     
     
         19 . A system of  claim 1 , further comprising:
 using the processor from the external device to generate a notification for delivery of a first round of medication.   
     
     
         20 . A system of  claim 1 , further comprising:
 using the processor from the external device to generate a notification for delivery of a second round of medication.   
     
     
         21 . A system of  claim 15 , further comprising:
 using the processor from the external device to monitor one of the implanted device memory data and the external device data after delivery of one of a first or a second round of medication.   
     
     
         22 . A system of  claim 1 , further comprising:
 using the processor from the external device to generate a notification to one of medical personnel and a patient for a blood sample to be acquired and tested.   
     
     
         23 . A system according to  claim 1  further comprising:
 using the processor from the external device to adjust therapy in response determining weight loss. 
 
     
     
         24 . A system according to  claim 1  further comprising:
 using the processor from the external device to adjust therapy in response determining blood pressure and a symptom. 
 
     
     
         25 . A system according to  claim 1  wherein the adjusted therapy involves cessation of one or more medications. 
     
     
         26 . A system according to  claim 23  wherein the adjusted therapy involves one or more medications being increased in dosage. 
     
     
         27 . A system according to  claim 1  wherein one or more baseline medications are examined. 
     
     
         28 . A system according to  claim 1  further comprising:
 using the processor from the external device to determine whether one of a set criteria has been met; and 
 using the processor from the external device to trigger review of one or more baseline medications in response to determining whether one of a set criteria has been met. 
 
     
     
         29 . A system according to  claim 26  wherein the one of the set criteria comprises:
 (a) average pre-specified time period impedance is less a threshold; 
 (b) two or more medication interventions occurred within a pre-specified amount of time; and 
 (c) two or more medication interventions were administered to the patient. 
 
     
     
         30 . A system according to  claim 27  wherein the threshold for the average pre-specified time period impedance is less than or about less than 66 Ohms. 
     
     
         31 . A system according to  claim 27  wherein the pre-specified time period is about three months. 
     
     
         32 . A system according to  claim 7  wherein the treatment plan comprises medication as a transient increase in diuretic or vasodilator. 
     
     
         33 . A method for determining whether to intervene with a patient's treatment, the method comprising:
 (a) sensing data through an implanted sensor;   (b) using an implanted processor to measure the data against a threshold stored in a memory of an implanted device to determine whether the data is considered to be indicative of a heart failure (HF) worsening episode occurrence;   (c) storing the occurrence in the memory of an implanted device;   (d) transmitting the occurrence to an external device;   (e) determining risk status from the occurrence and any other applicable data using the external device;   (f) acquiring additional data, the additional data being related to one of weight, symptoms, and blood pressure; and   (g) using the external device to determine whether to adjust the patient's treatment plan comprising a set of pharmaceutical physician prescriptions in response to the risk status, the data acquired from the implanted device memory and the one or more other external devices, the external device configured to signal a user device as to adjustment of a patient's treatment plan.   
     
     
         34 . The method of  claim 33  wherein the additional data is acquired from one or more other external devices. 
     
     
         35 . The method of  claim 34  wherein the additional data related to the blood pressure is acquired from the implantable processor or another implantable processor associated with another implantable device. 
     
     
         36 . The method of  claim 1  wherein the indication of the HF worsening episode occurrence is based on a result of measuring the sensed data against the threshold. 
     
     
         37 . A method of  claim 33  wherein the implanted sensor is mechanically and electrically connected to the implanted device. 
     
     
         38 . A method of  claim 33  wherein the implanted sensor is not mechanically connected to the implanted device. 
     
     
         39 . A method according to  claim 33  further comprising:
 storing a treatment plan into a memory of the external device, the treatment plan comprising a first round of medication and a second round of medication. 
 
     
     
         40 . A method according to  claim 39  wherein the treatment plan comprises delivery of a prescribed medication, the prescribed medication adjusted without directly communicating with the patient's physician any time after storing the treatment plan into memory. 
     
     
         41 . A method of  claim 33 , further comprising:
 displaying the adjusted treatment on a graphical user interface in response to determining that the patient's treatment requires adjustment.   
     
     
         42 . A method of  claim 33 , further comprising:
 acquiring raw impedance data after a prescribed period of time in response to adjusting the treatment of the patient; and   using the raw impedance data to determine whether the patient is improving in response to the treatment.   
     
     
         43 . A method of  claim 33 , further comprising:
 determining whether the raw impedance data, acquired from the implanted device memory, crosses a threshold; and   in response to determining whether the raw impedance data crosses the threshold, determining whether the raw impedance data is considered a heart failure exacerbation.   
     
     
         44 . A method of  claim 42 , wherein the raw impedance data that is a non-heart failure exacerbation does not require an intervention by a healthcare system. 
     
     
         45 . A method of  claim 42 , wherein the non-heart failure exacerbation does not cause an adjustment to treatment. 
     
     
         46 . A method of  claim 45 , wherein the non-heart failure exacerbation triggers a notification to medical personnel. 
     
     
         47 . A method of  claim 45 , wherein the non-heart failure exacerbation does not trigger an intervention. 
     
     
         48 . A method of  claim 45 , wherein the raw impedance data that is a heart failure exacerbation that requires an intervention by a healthcare system. 
     
     
         49 . A method of  claim 39 , further comprising:
 determining whether to terminate adjusted treatment in response to data monitored after treatment was adjusted.   
     
     
         50 . A method of  claim 49 , wherein termination of adjusted treatment is based upon one of patient blood pressure, and symptoms. 
     
     
         51 . A method of  claim 33 , further comprising:
 generating a notification for delivery of a first round of medication.   
     
     
         52 . A method of  claim 33 , further comprising:
 generating a notification for delivery of a second round of medication.   
     
     
         53 . A method of  claim 49 , further comprising:
 monitoring one of the implanted device memory data and the external device data after delivery of one of a first or a second round of medication.   
     
     
         54 . A method of  claim 33 , further comprising:
 generating a notification to one of medical personnel and a patient for a blood sample to be acquired and tested.   
     
     
         55 . A method according to  claim 33  further comprising:
 adjusting therapy in response determining weight loss. 
 
     
     
         56 . A method according to  claim 33  further comprising:
 adjusting therapy in response determining blood pressure and a symptom. 
 
     
     
         57 . A method according to  claim 33  wherein the adjusted therapy involves cessation of one or more medications. 
     
     
         58 . A method according to  claim 55  wherein the adjusted therapy involves one or more medications being increased in dosage. 
     
     
         59 . A method according to  claim 33  wherein one or more baseline medications are examined. 
     
     
         60 . A method according to  claim 33  further comprising:
 determining whether one of a set criteria has been met; and 
 triggering review of one or more baseline medications in response to determining whether one of a set criteria has been met. 
 
     
     
         61 . A method according to  claim 58  wherein the one of the set criteria comprises:
 (a) average pre-specified time period impedance is less a threshold; 
 (b) two or more medication interventions occurred within a pre-specified amount of time; and 
 (c) two or more medication interventions were administered to the patient. 
 
     
     
         62 . A method according to  claim 59  wherein the threshold for the average pre-specified time period impedance is less than or about less than 66 Ohms. 
     
     
         63 . A method according to  claim 59  wherein the pre-specified time period is about three months. 
     
     
         64 . A method according to  claim 34  wherein the treatment plan comprises medication as a transient increase in diuretic or vasodilator. 
     
     
         65 . A method for determining whether to intervene with a patient's treatment, the method comprising:
 (a) sensing data through an implanted sensor;   (b) using an implanted processor to measure the data against a threshold stored in a memory of an implanted device to determine whether the data is considered to indicative of an HF episode occurrence;   (c) storing the occurrence in the memory of an implanted device;   (d) transmitting the occurrence to an external device;   (e) determining risk status from the occurrence and any other applicable data using the external device;   (f) acquiring additional data from one or more other external devices, the additional data being related to one of weight, symptoms, and blood pressure; and   (g) using the external device to determine whether to adjust treatment of the patient in response to the risk status;   (h) storing a treatment plan into a memory of the one or more external devices, the treatment plan comprising a first round of medication and a second round of medication, the treatment plan comprises a prescribed medication, the prescribed medication adjusted without being required to directly communicating with the patient's physician any time after storing the treatment plan,   the one or more external devices configured to signal a patient's user device indicating a change in the patient's treatment plan.   
     
     
         66 . A system for determining whether to intervene with a patient's treatment, the system comprising:
 an implantable device having a memory;   an implantable sensor;   an implantable processor;   an external device;   sensing means for sensing data through the implanted sensor;   
       the implanted processor configured to compare the data against a threshold stored in the memory of the implanted device to determine whether the data is considered to be indicative of a heart failure (HF) worsening episode occurrence based on a result of the comparison;
 storing means for storing a determined occurrence in the memory of the implanted device; 
 transmitting means for transmitting the occurrence to the external device; 
 processing means for determining a risk status from the occurrence and any other applicable data using the external device; 
 means for acquiring additional data, the additional data being one of weight, symptoms, and blood pressure; 
 the external device configured to determine whether to adjust the patient's treatment based on the risk status, the data acquired from the implanted device memory and the one or more other external devices; and 
 a treatment plan stored into a memory of the one or more external devices or memory associated with the external device, the treatment plan comprising a first round of medication and a second round of medication, the treatment plan comprises a prescribed medication, the prescribed medication adjusted without being required to directly communicate with the patient's physician any time after storing the treatment plan into memory. 
 
     
     
         67 . A system of  claim 66 , wherein an automatic drug dispenser in configured to automatically deliver a proper dosage for a set of prescribed medications, 
     
     
         68 . A system of  claim 67 , wherein the automatic drug dispenser withholds a previous dosage once the processor means determines another dosage is required. 
     
     
         69 . A system of  claim 67  wherein the automatic drug dispenser is configured to provide a set of containers, each container is configured to store a unique dosage of medication from another container of the set of containers. 
     
     
         70 . A system for determining whether to intervene with a patient's treatment, the system comprising:
 an implantable device having a memory;   an implantable sensor;   an implantable processor;   an external device;   sensing means for sensing data through the implanted sensor;   
       the implanted processor configured to compare the data against a threshold(s) stored in the memory of the implanted device to determine whether the data is considered to be indicative of a heart failure (HF) worsening episode occurrence based on a result of the comparison;
 storing means for storing a determined occurrence in the memory of the implanted device; 
 transmitting means for transmitting the occurrence to the external device; 
 processing means for determining a risk status from the occurrence and any other applicable data using the external device; 
 means for acquiring additional data, the additional data being one of weight, symptoms, and blood pressure; 
 the external device configured to determine whether to adjust the patient's treatment based on a prediction that worsening HF is occurring, the data acquired from the implanted device memory, the external device or the one or more other external devices; and 
 a treatment plan stored into a memory of the one or more external devices or memory associated with the external device, the treatment plan comprising a first round of medication and a second round of medication, the treatment plan adjusted without being required to directly communicate with the patient's physician any time after storing the treatment plan into memory. 
 
     
     
         71 . A system for determining whether to intervene with a patient's treatment, the system comprising:
 an implantable device having a memory;   an implantable sensor;   an implantable processor;   an external device;   sensing means for sensing data through the implanted sensor;   
       the implanted processor configured to compare the data against a threshold(s) stored in the memory of the implanted device to determine whether the data is considered to be indicative of a heart failure (HF) worsening episode occurrence based on a result of the comparison;
 storing means for storing a determined occurrence in the memory of the implanted device; 
 transmitting means for transmitting the occurrence to the external device; 
 processing means for predicting increased bodily fluid from the occurrence and any other applicable data using the external device; 
 means for acquiring additional data, the additional data being one of weight, symptoms, and blood pressure; 
 the external device configured to determine whether to adjust the patient's treatment based on the prediction of increased fluid, the data acquired from the implanted device memory, the external device or the one or more other external devices; and 
 a treatment plan stored into a memory of the one or more external devices or memory associated with the external device, the treatment plan comprising a first round of medication and a second round of medication, the treatment plan adjusted without being required to directly communicate with the patient's physician any time after storing the treatment plan into memory. 
 
     
     
         72 . A system for determining whether to intervene with a patient's treatment, the system comprising:
 an implantable device having a memory;   an implantable sensor;   an implantable processor;   an external device;   sensing means for sensing data through the implanted sensor;   
       the implanted processor configured to compare the data against a threshold(s) stored in the memory of the implanted device to determine whether the data is considered to be indicative of a heart failure (HF) worsening episode occurrence based on a result of the comparison;
 storing means for storing a determined occurrence in the memory of the implanted device; 
 transmitting means for transmitting the occurrence to the external device; 
 processing means for predicting worsening HF from the occurrence and any other applicable data using the external device; 
 means for acquiring additional data, the additional data being one of weight, symptoms, and blood pressure; 
 the external device configured to determine whether to adjust the patient's treatment based on the prediction of worsening HF, the data acquired from the implanted device memory, the external device or the one or more other external devices; and 
 a treatment plan stored into a memory of the one or more external devices or memory associated with the external device, the treatment plan comprising a first round of medication and a second round of medication, the treatment plan adjusted without being required to directly communicate with the patient's physician any time after storing the treatment plan into memory.