Medical treatment using patient states, patient alerts, and hierarchical algorithms

• US 20080288023A1
• Filed: 08/30/2006
• Published: 11/20/2008
• Est. Priority Date: 08/31/2005
• Status: Abandoned Application

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Application Number:
  US11/309,605
• Publication Number:
  US 20080288023A1
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Systems and methods are described for adjusting the operation of implantable stimulation devices used to provide medical treatment. Several hierarchical algorithms are described which operate according to conditional strategies. In one such strategy semi-automatic therapy adjustment occurs by automatically issuing patient alert messages when selected operations are to occur, and using a patient'"'"'s response to the alert message in order to adjust therapy, as long as this is provided within a selected time limit. Another strategy only implements complex operations when these are indicated by prior operations. The invention serves to reduce the risk of adaptation by the patient and the provision of therapy operations that are either not desired or warranted, in order to decrease the depletion of battery power and/or drug reserves and increase patient benefit. Methods are also described for resolving data conflicts which may occur when adaptively delivery therapy.

Claims

1. A method for treating a human patient with an implantable device, the method comprising the steps of:

operating using a primary treatment protocol;

when an operating condition is satisfied, providing a notice to a user;

waiting a selected duration for a response from the user; and

,

subsequently operating using a secondary treatment protocol depending on the response from the user.

2. The method for treating a human patient with an implantable device of claim 1, wherein the method further includes the steps of replacing the primary treatment protocol with the secondary treatment protocol to redefine the primary treatment protocol, and continuing to operate using the redefined primary treatment protocol.

3. The method for treating a human patient with an implantable device of claim 1, wherein the user is at least one of:

the human patient;

a caregiver for the human patient; and

a physician.

4. The method for treating a human patient with an implantable device of claim 1, wherein the response from the user is implemented according to patient response rules, and said response is at least one of the following:

an “

accept”

response;

a “

reject”

response;

a “

no response”

response;

a “

delay”

request;

a “

reminder”

request;

a “

more info”

request; and

a request to choose at least one from a plurality of proposed operations.

5. The method for treating a human patient with an implantable device of claim 1, wherein the device operates as a part of a system having at least one external component.

6. The method for treating a human patient with an implantable device of claim 1, wherein the primary treatment protocol and the secondary treatment protocol are stimulation protocols.

7. The method for treating a human patient with an implantable device of claim 6, wherein the secondary treatment protocol has a parameter that is different from a corresponding parameter of the main treatment protocol.

8. The method for treating a human patient with an implantable device of claim 7, wherein the parameter differs by a clinically relevant value.

9. The method for treating a human patient with an implantable device of claim 7, wherein the parameter differs by at least 30%.

10. The method for treating a human patient with an implantable device of claim 1, wherein the primary treatment protocol and the secondary treatment protocol include at least one of:

sensing protocols;

evaluation protocols; and

detection protocols.

11. The method for treating a human patient with an implantable device of claim 10, wherein the secondary treatment protocol has a parameter that is different from a corresponding parameter of the primary treatment protocol.

12. The method for treating a human patient with an implantable device of claim 11, wherein the parameter differs by a clinically significant value.

13. The method for treating a human patient with an implantable device of claim 11, wherein the parameter differs by at least 30%.

14. The method for treating a human patient with an implantable device of claim 1, wherein the operating condition comprises at least one of:

a time of day;

an elapsed time;

a detected event;

a detected medical event;

an alert event;

a selected measurement from a sensor;

a patient state value;

a measured patient state; and

a predicted patient state.

15. The method for treating a human patient with an implantable device of claim 1, wherein the step of providing notice comprises providing a sensory alert to the patient using the implantable device;

and wherein the sensory alert is at least one of;

a sensory alert that uses a particular color;

a sensory alert that uses a particular pattern;

a sensory alert that varies over time in a defined manner if the patient does not make a response; and

a sensory alert which is specific to a particular operation.

16. The method for treating a human patient with an implantable device of claim 1, wherein the step of providing notice comprises providing an alert signal to the patient comprising at least one of the following:

a sensory alert;

a visual alert;

a sonic alert;

a vibrotactile alert; and

a text message.

17. The method for treating a human patient with an implantable device of claim 1, wherein the step of providing notice comprises providing an alert signal according to at least one patient alert rule.

18. The method for treating a human patient with an implantable device of claim 1, wherein the response from the user is used to adjust the secondary treatment protocol according to at least one patient response rule.

19. The method for treating a human patient with an implantable device of claim 1, wherein the step of providing notice comprises providing an alert signal to at least one of the following:

the implantable device; and

a programmer in communication with the implantable device.

20. The method for treating a human patient with an implantable device of claim 1, wherein the step of awaiting a response comprises continuing to operate according to at least one patient alert rule.

21. The method for treating a human patient with an implantable device of claim 1, wherein the step of awaiting a response comprises continuing to operate using the primary treatment protocol for a period of time or until the response is received.

22. The method for treating a human patient with an implantable device of claim 1, wherein the step of operating using the secondary treatment protocol is performed according to at least one of the following patient response rules:

operating using the secondary treatment protocol if the response is received from the user;

operating using the secondary treatment protocol if no response is received from the user; and

, operating using the secondary treatment protocol if no response is received from the user within a selected time.

23. The method for treating a human patient with an implantable device of claim 1, further comprising the step of selecting the second treatment protocol based on the response received from the user, prior to the step of operating using the second treatment protocol.

24. A system for semi-automatically treating a disorder in a human patient, the system comprising:

an implantable device configured to provide treatment according to a treatment protocol and to provide stimulation treatment to the patient through at least one stimulation conduit;

a patient notification module, having at least one alert event in a defined set of alert events, wherein the patient notification module is configured to provide notice to a user of the system when an alert event is detected and to obtain a user response from the user within a specified time period; and

,

a control module configured to cause a treatment adjustment based upon the user response.

25. The system of claim 24, wherein the patient notification unit is at least one of:

a module of the implantable device; and

a module of a programmer in communication with the implantable device.

26. The system of claim 24, wherein the control module is at least one of:

a part of the implantable device; and

a part of a programmer in communication with the implantable device.

27. A system for semi-automatically determining a patient state of a human patient, the system comprising:

a processor implementing a control program configured to identify an occurrence of an event for which patient alerting should occur;

wherein the control program is further configured to control a patient alert module to automatically provide an alert signal for the event; and

wherein the control program is further configured to determine a patient state based upon a user response to the alert signal.

28. The system of claim 27 wherein the step of determining a patient state occurs according to at least one alert response rule, wherein the alert response rule provides for at least one of the following:

an adjustment of a patient state value;

a choice between at least two patient state values;

an acceptance of a patient state value; and

a rejection of a patient state value.