Systems and methods for facilitating patient-based adjustment of drug infusion

• US 9,649,439 B2
• Filed: 06/13/2016
• Issued: 05/16/2017
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/180,694
• Publication Number:
  US 20160303322A1
• Time in Patent Office: 337 Days
• Field of Search: None
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/20 : relating to practices or guidelines

Abstract

A drug infusion system located at least partially external to the patient having a pump and a patient programmer control configured to present to the patient a question and receive patient input information in response thereto. A patient response rule module is configured to apply a rule to the input information provided by a patient. For example, the patient response rule can be used to provide an insulin pump setting according to the patient response rule or to provide a setting, or to provide a setting that is proposed to the user. Other systems and methods are also described such as asking questions related to the adjustment of future therapy settings.

Claims

1. A method of operating a drug infusion system comprising:

establishing an external patient programmer operating communication circuitry of a communication module for providing communication within a drug infusion system containing a pump realized at least partially external to a patient and being configured to deliver drug therapy to a patient;

presenting to the patient on the external patient programmer a set of at least one question relating to the drug therapy;

receiving patient input information in the external patient programmer, said patient input information generated by the patient in response to the set of at least one question relating to the drug therapy;

establishing and operating a patient alert module containing at least one patient response rule;

applying a patient response rule to the patient input information within a processing module of a control subsystem wherein the patient input information is operated upon by a processor using an algorithm for realizing the at least one patient response rule in cooperation with the patient input information; and

,

generating, using the processor, a proposed parameter value for at least one drug infusion system protocol parameter setting as a function of the patient response rule, the protocol parameter setting stored in memory for use in determining therapy delivered by the drug infusion system.

2. The method of claim 1, wherein the set of at least one question relating to the drug therapy includes at least one question selected from the group of:

information known by the patient, and preferences of the patient.

3. The method of claim 1, wherein the therapy delivered by the drug infusion system is related to a future therapy which anticipates a future need of the patient.

4. The method of claim 1, wherein the set of at least one question presented to the patient is pre-emptive and includes asking a patient to respond to at least one anticipatory question about a future event.

5. The method of claim 1, wherein the patient response rule is operated upon in accordance with at least one selected from the group of:

an algorithm, a control law; and

, an evaluation protocol.

6. The method of claim 1, wherein the set of at least one question presented to the patient is selected from at least one of the group consisting of:

related to information about the patient'"'"'s food intake, related to information about the patient'"'"'s mood, and related to information about a future event.

7. The method of claim 1, further including:

(a) generating a proposed adjustment for the at least one drug infusion system protocol parameter setting; and

,

(b) presenting the proposed adjustment related to initiating therapy to the patient.

8. The method of claim 7, wherein the proposed adjustment for the at least one drug infusion system protocol parameter setting includes presenting a request for confirmation of the setting and operating drug infusion system according to a user input response provided to the patient programmer.

9. The method of claim 7, wherein the proposed adjustment for the at least one drug infusion system protocol parameter setting includes a threshold related to a glucose level of the patient.

10. The method of claim 1, further comprising:

(a) operating the drug infusion system to obtain sensed glucose data; and

,

(b) operating the drug infusion system according to an evaluation protocol that assesses both sensed and patient input information to adjust at least one protocol parameter setting.

11. A drug infusion system including:

(a) a pump that is realized at least partially external to the patient;

(b) an external patient programmer

(c) a patient alert module, said patient alert module configured to;

(i) present a set of at least one question to a patient relating to a drug therapy using the external patient programmer for controlling and providing communication with the pump of the drug infusion system;

(ii) receive patient input information from the patient in response to the set of at least one question provided by the external patient programmer, said patient alert module containing at least one patient response rule, the patient alert module further configured to;

(iii) apply the at least one patient response rule to the patient input information, where the patient response rule is operated upon by an algorithm to realize the patient response rule; and

(iv) generate a proposed parameter value for at least one drug infusion system protocol parameter setting from application of the patient response rule, the protocol parameter setting stored in a processor memory for use in determining therapy delivered by the drug infusion system.

12. The system of claim 11, wherein therapy delivered by the drug infusion system is related to a future therapy that anticipates a future need of the patient.

13. The system of claim 11, wherein the set of at least one question presented to a patient is pre-emptive and includes requesting a patient to respond to at least one anticipatory question about a future event.

14. The system of claim 11, wherein the patient response rule that is operated upon is selected from the group including:

an algorithm, a control law, and, an evaluation protocol.

15. The system of claim 11, wherein at least one question from the set of at least one question presented to the patient is selected from at least one of the group of:

patient food intake, patient mood, and information about a future event.

16. The system of claim 11, further comprising:

a processor memory communicatively coupled to the external patient programmer, the processor memory adapted to store protocol parameters associated with the pump of the drug infusion system related to the initiation of the therapy delivered by the drug infusion system.

17. The system of claim 11, further including a communication module having a physical communication port communicatively coupling the pump and the external patient programmer, wherein the patient alert module is configured to:

(a) present the protocol parameter setting to a user;

(b) present a request for confirmation of the protocol parameter setting; and

,

(c) communicate the protocol parameter setting to the pump via the physical communication port when a confirmation is received from the patient providing input to the patient programmer.

18. The system of claim 11, including a patient response rule module configured to generate a threshold glucose level as part of the protocol parameter setting.

19. The system of claim 11, wherein the drug infusion system is further configured to receive glucose data information and the patient alert rule module is further configured to apply the rule to the glucose data information.

20. The system of claim 19, wherein the drug infusion system is configured to receive the patient information and the glucose data information and wherein the patient response rule is configured to generate the pump protocol parameter setting value based on application of the patient response rule to both the patient input information and the glucose information, as defined by a treatment protocol.