Titration for medical infusion devices and systems

Abstract

Titration schemes are carried out by medical infusion devices, such as ambulatory or implantable infusion devices. The titration schemes carried out by infusion systems and devices may take into account patient side effects in controlling the rate at which a medicament is delivered from the devices of systems.

1 . A medical infusion device, comprising:
 a reservoir for housing a liquid composition comprising a medicament;   a pump mechanism configured to drive the liquid composition from the reservoir to a patient;   input apparatus configured to receive input indicative of a patient side effect of the medicament; and   control electronics operably coupled to the pump mechanism and to the input apparatus,   wherein the control electronics are configured to:
 (a) cause the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period of time at a rate increased relative to a preceding rate if no input indicative of a patient side effect has been received during a period of time in which the pump mechanism drove the liquid composition from the reservoir to the patient at the preceding rate; and 
 (b) repeat step (a) until a maximum predetermined rate has been achieved or until input indicative of a patient side effect is received. 
   
     
     
         2 . The medical infusion device of  claim 1 , wherein, if input indicative of a patient side effect is received, the control electronics are further configured to cause the pump mechanism to drive the liquid composition from the reservoir to the patient at a rate decreased relative to a rate in a time period in which the input indicative of a patient side effect is received. 
     
     
         3 . The medical infusion device of  claim 2 , where the control electronics are further configured to:
 (c) cause the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period of time at a rate increased relative to the decreased rate but decreased relative to the rate in the time period in which input indicative of the patient side effect was received;   (d) cause the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period of time at a rate increased relative to a preceding rate, but at an increment smaller than an increment in step (b), if no input indicative of a patient side effect has been received during a period of time in which the pump mechanism drove the liquid composition from the reservoir to the patient at the preceding rate; and   (e) repeat step (d) until a maximum predetermined rate has been achieved or until input indicative of a patient side effect is received.   
     
     
         4 . The medical infusion device of  claim 2 , where the control electronics are further configured to:
 (c) cause the pump mechanism to drive the liquid composition from the reservoir to the patient at the decreased rate for a period of time longer than the predetermined period of time of the time period in which input indicative of the patient side effect was received;   (d) cause the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period, which predetermined period of time is longer than a predetermined period of time in step (b), at a rate increased relative to a preceding rate if no input indicative of a patient side effect has been received during a period of time in which the pump mechanism drove the liquid composition from the reservoir to the patient at the preceding rate; and   (e) repeat step (d) until a maximum predetermined rate has been achieved or until input indicative of a patient side effect is received.   
     
     
         5 . The medical infusion device of  claim 2 , where the control electronics are further configured to:
 (c) cause the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period of time, which predetermined period of time is longer than the predetermined period of time in the time period in which input indicative of the patient side effect was received, at a rate increased relative to the decreased rate but decreased relative to the rate in the time period in which input indicative of the patient side effect was received;   (d) cause the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period of time, which predetermined period of time is longer than a predetermined period of time in step (b), at a rate increased relative to a preceding rate, but at an increment smaller than an increment in step (b), if no input indicative of a patient side effect has been received during a period of time in which the pump mechanism drove the liquid composition from the reservoir to the patient at the preceding rate; and   (e) repeat step (d) until a maximum predetermined rate has been achieved or until input indicative of a patient side effect is received.   
     
     
         6 . The medical infusion device of  claim 1 , wherein the control electronics are further configured to cause the pump mechanism to drive the liquid composition from the reservoir to the patient at an immediately preceding rate if input indicative of a patient side effect is received in a given time period. 
     
     
         7 . The medical infusion device of  claim 1 , wherein the control electronics are further configured to cause the pump mechanism to drive the liquid composition from the reservoir to the patient at rate equivalent to a rate in two time periods prior to a rate in a time period in which input indicative of a patient side effect was received. 
     
     
         8 . The medical infusion device of  claim 1 , wherein the predetermined period of time in each iteration of step (a) is between twelve hours and one week. 
     
     
         9 . The medical infusion device of  claim 1 , wherein the predetermined period of time in each iterative step (a) is about three days. 
     
     
         10 . The medical infusion device of  claim 1 , wherein the infusion device is an ambulatory infusion device configured to transcutaneously deliver the liquid composition to the patient. 
     
     
         11 . The medical infusion device of  claim 1 , wherein the infusion device is an ambulatory infusion device configured to deliver the liquid composition to a subcutaneous space of the patient. 
     
     
         12 . A medical infusion system comprising:
 a first device having first control electronics and having, or configured to operably couple to, (i) a first reservoir for housing a liquid composition comprising a medicament, (ii) a first pump mechanism configured to drive the liquid composition from the first reservoir to a patient, and (iii) first input apparatus configured to receive input indicative of a patient side effect of the medicament, wherein the first control electronics are operably coupled to the first pump mechanism and to the first input apparatus, and wherein the first control electronics are configured:
 (a) to cause the first pump mechanism to drive the liquid composition from the first reservoir to the patient for a predetermined period of time at a rate increased relative to a preceding rate if no input indicative of a patient side effect has been received during a period of time in which the first pump mechanism drove the liquid composition from the first reservoir to the patient at the preceding rate; and 
 (b) to repeat step (a) until a maximum predetermined rate has been achieved or until input indicative of a patient side effect is received; and 
   a second device having second control electronics and having, or configured to operably couple to, (i) a second reservoir for housing a liquid composition comprising a medicament, (ii) a second pump mechanism configured to drive the liquid composition from the second reservoir to a patient, and (iii) second input apparatus configured to receive input indicative of a patient side effect of the medicament, wherein the second control electronics are operably coupled to the second pump mechanism and to the second input apparatus, and wherein the second control electronics are configured:
 (c) to cause the second pump mechanism to drive the liquid composition from the second reservoir to the patient for a predetermined period of time at a rate increased relative to a preceding rate if no input indicative of a patient side effect has been received during a period of time in which the second pump mechanism drove the liquid composition from the second reservoir to the patient at the preceding rate; and 
 (d) to repeat step (c) until a maximum predetermined rate has been achieved or until the second control electronics determine that input indicative of a patient side effect is received, 
   wherein the first and second pump mechanisms are the same or different,   wherein the first and second reservoirs are the same or different,   wherein the first and second input apparatuses are the same or different, and   wherein the first and second devices are configured to be employed by the patient sequentially such that the second device is employed by the patient to deliver the medicament after the first device is no longer being used to deliver the medicament, and   wherein the first device is configured to transmit to the second device data regarding the last rate at which the first pump mechanism was configured to drive the liquid composition from the first reservoir to the patient, and wherein the second control electronics are configured to set the last rate of the first pump mechanism as the initial rate of the second pump mechanism in step (c).   
     
     
         13 . The medical infusion system of  claim 12 , wherein, if input indicative of a patient side effect is received, the first control electronics are further configured to cause the first pump mechanism to drive the liquid composition from the first reservoir to the patient at a rate decreased relative to a rate in a time period in which the input indicative of the patient side effect was received. 
     
     
         14 . The medical infusion system of  claim 12 , wherein, if input indicative of a patient side effect is received, the second control electronics are further configured to cause the second pump mechanism to drive the liquid composition from the second reservoir to the patient at a rate decreased relative to a rate in a time period in which the input indicative of the patient side effect was received. 
     
     
         15 . The medical infusion system of  claim 12 , wherein the first device is configured to transmit to the second device data regarding whether input indicative of a patient side effect has been received. 
     
     
         16 . The medical infusion system of  claim 15 , wherein the second control electronics are configured to cause the second pump mechanism to drive the liquid composition at the last rate of the first pump mechanism without increasing the rate in step (c) if the second device receives data from the first device indicating that the first apparatus received input indicative of a patient side effect. 
     
     
         17 . The medical infusion system of  claim 12 , wherein the first and second devices are ambulatory devices. 
     
     
         18 . A method of titrating dosage of a medicament from a medical infusion device, the medical infusion device having a reservoir for housing a liquid composition comprising a medicament and pump mechanism for driving the liquid composition from the reservoir to a patient, the method carried out by control electronics of the medical infusion device and comprising:
 (a) determining whether input indicative of a patient side effect has been received;   (b) causing the pump mechanism to drive the liquid composition from the reservoir to the patient for a predetermined period of time at a rate increased relative to a preceding rate if a determination is made that no input indicative of a patient side effect has been received during a period of time in which the pump mechanism drove the liquid composition from the reservoir to the patient at the preceding rate; and   (c) repeating steps (a) and (b) until a maximum predetermined rate has been achieved or until a determination is made that input indicative of a patient side effect has been received.   
     
     
         19 . The method of  claim 18 , further comprising causing the pump mechanism to drive the liquid composition from the reservoir to the patient at a rate decreased relative to a current rate if input indicative of a patient side effect has been determined to have been received in a current time period. 
     
     
         20 . A medical infusion device configured to carry out the method of  claim 18 . 
     
     
         21 . A non-transitory computer-readable medium that, when implemented by a medical infusion device, causes the infusion device to carry out the method of  claim 18 . 
     
     
         22 . A method of titrating dosage of a medicament from a medical infusion system sequentially employing first and second devices to deliver the medicament to a patient such that the second device replaces the first device to deliver the medicament to the patient after the first device is no longer employed to deliver the medicament, the method comprising:
 (1) employing control electronics of the first device to:
 (a) determine whether input indicative of a patient side effect has been received; 
 (b) cause a liquid composition comprising the medicament to be delivered to a patient for a predetermined period of time at a rate increased relative to a preceding rate if a determination is made that no input indicative of a patient side effect has been received during a period of time in the liquid composition was driven at the preceding rate; and 
 (c) repeat steps (a) and (b) until a maximum predetermined rate has been achieved or until the determination is made that input indicative of a patient side effect has been received or until the first device is replaced by the second device; and 
   (2) replacing the first device with the second device, transmitting data to the second device regarding the last rate at which the first device caused the liquid composition to be delivered to the patient, and transmitting data to the second device regarding whether input indicative of a patient side effect has been received; and   (3) employing control electronics of the second device to:
 (d) cause the liquid composition comprising the medicament to be delivered to the patient at the last rate at which the first device caused the liquid composition to be delivered to the patient if the transmitted data indicates that the maximum predetermined rate has been achieved or that input indicative of a patient side effect has been received; or 
 (e) if the transmitted data indicates that the maximum predetermined rate has not been achieved and that no input indicative of a patient side effect has been received,
 (i) cause the liquid composition comprising the medicament to be delivered to the patient for a predetermined period of time at the last rate at which the first device caused the liquid composition to be delivered to the patient or a rate increased relative to the last rate at which the first device caused the liquid composition to be delivered to the patient; 
 (ii) determine whether input indicative of a patient side effect has been received; 
 (iii) cause the liquid composition comprising the medicament to be delivered to the patient for a predetermined period of time at a rate increased relative to a preceding rate if a determination is made that no input indicative of a patient side effect has been received during a period of time in the liquid composition was driven at the preceding rate; and 
 
 (a) (iv) repeat steps (ii) and (iii) until a maximum predetermined rate has been achieved or until the determination is made that input indicative of a patient side effect has been received. 
   
     
     
         23 . A method for titrating dosage of a medicament from a medical system employing first and second infusion devices to deliver the medicament to a patient, wherein the system optionally comprises an auxiliary device in communication with the first and second infusion devices, the method carried out by (i) the first and second infusion devices or (ii) the first and second infusion devices and the auxiliary device and comprising:
 (a) infusing a liquid composition comprising a medicament from a first infusion device to a patient;   (b) infusing a liquid composition comprising the medicament from a second infusion device to the patient;   (c) determining the combined rate of infusion from the first device and the second device;   (d) determining whether a maximum combined rate has been achieved;   (e) determining whether input indicative of a patient side effect has been received;   (f) infusing the liquid composition from the first and second devices for a predetermined period of time at a predetermined combined rate increased relative to a preceding rate if a determination is made that no input indicative of a patient side effect has been received during a period of time in which the pump mechanism drove the liquid composition from the reservoir to the patient at the preceding rate and if the maximum combined rate has not been achieved; and   (g) repeating steps (d) through (f) until a maximum predetermined rate has been achieved or until a determination is made that input indicative of a patient side effect has been received.   
     
     
         24 . The method of  claim 23 , further comprising:
 (h) increasing the rate of infusion from the second device and decreasing the rate of infusion from the first device to maintain a combined infusion rate;   (i) determining whether the first infusion device is infusing the liquid composition at a rate below a predetermined threshold;   (j) repeating steps (h) and (i) until the first infusion device is infusing the liquid composition below the threshold; and   (k) removing the first infusion device from the patient if the first device is infusing the liquid composition below the threshold.