Patient specific data driven safety interlocks for medical devices

• US 9,345,889 B2
• Filed: 07/25/2014
• Issued: 05/24/2016
• Est. Priority Date: 07/25/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hess, Michael F.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/341,227
• Publication Number:
  US 20160023001A1
• Time in Patent Office: 669 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

A medical device is provided that includes an input/output, at least one sensor, a memory, a controller and at least one delivery member. The input/output is configured to provide a communication path to and from the medical device. The at least one sensor is used to monitor at least one patient function. The memory is used to store patient specific data from the at least one sensor and operating parameters of the medical device. The controller is used to control operations of the medical device. The controller is in communication with the at least one sensor, the memory and the input/output. The controller is configured to deny device operational change requests received via the input/output based at least in part on the patient specific data sensed by the at least one sensor. The at least one delivery member is under the control of the controller and is configured to provide a therapeutic function of the medical device.

Claims

1. A method of generating patient specific interlocks for a medical device, the method comprising:

sensing at least one patient function of a patient with a medical device;

collecting sensed patient function data from the sensing of the at least one patient function;

analyzing the collected patient function data; and

based at least in part on the analyzed collected patient function data, generating at least one patient specific interlock that denies specific operational change requests to the medical device.

2. The method of claim 1 further comprising:

dynamically changing the at least one patient specific interlock based on then current patient function data.

3. The method of claim 1, wherein generating the at least one patient specific interlock further comprises:

using externally provided patient specific data along with the analyzed collected patient function data.

4. The method of claim 1, wherein generating the at least one patient specific interlock, further comprises:

setting prohibited operating parameter requests for the medical device.

5. The method of claim 4, wherein the prohibited operating parameter requests further comprise at least one of prohibiting specific pacing rate requests, pacing mode requests, threshold test requests, rates of response requests, tracking modes requests, permanent output setting requests that lose capture, output to super-threshold value requests, requests that effect the longevity of the medical device and symptomatic tracking requests.

6. The method of claim 1, wherein measuring the at least one patient function of the patient with a medical device further comprises:

measuring electrical activity of the patient'"'"'s heart.

7. The method of claim 1, wherein the at least one patient specific interlock that denies specific operational change requests is created to be unique to at least one of who is requesting the operational change of the medical device and the location of the medical device when the request is received.

8. The method of claim 1 wherein analyzing data from the collected patient function data further comprises at least one of determining if the patient function data indicates a ventricular pacing percent that is above a select percentage, determining if the patient function data indicates an atrial pacing percent that is above a select percentage, determining if the patient function data indicates that the patient is in atrial fibrillation and determining if the patient function data indicates the patient is showing signs of heart failure.

9. A method of operating a medical device, the method comprising:

measuring at least one patient function with the medical device;

when a request is received at an input to the medical device to change at least one operating parameter of a medical device, applying at least one patient specific interlock that is based at least in part on the at least one measured patient function to determine if the requested change to the at least one operating parameter of the medical device should be permitted; and

denying the input request to change the at least one operating parameter of the medical device when it is determined that the at least one patient specific interlock does not allow the requested change.

10. The method of claim 9, further comprising:

generating the at least one patient specific interlock with patient specific data from the measured at least one patient function.

11. The method of claim 10, further comprising:

generating at least some of the patient specific data from externally provided patient information; and

using the external patient information at least in part to generate the patient specific interlock.

12. The method of claim 9, further comprising:

dynamically changing the at least one patient specific interlock based on then current measured at least one patient function.

13. The method of claim 9, further comprising:

analyzing patient specific data from the measured at least one patient function; and

setting allowable parameters of the medical device based at least in part on the analyzed patient specific data.

14. The method of claim 9, wherein the at least one patient specific interlock prohibits at least one of specific pacing rate requests, pacing mode requests, threshold test requests, rates of response requests, tracking mode requests, permanent output setting requests that lose capture, output to super-threshold value requests, requests that effect the longevity of the medical device and symptomatic tracking requests.

15. A medical device comprising:

an input/output configured to provide a communication path to and from the medical device;

at least one sensor to monitor at least one patient function;

a memory to store patient specific data from the at least one sensor and operating parameters of the medical device;

a controller to control operations of the medical device, the controller in communication with the at least one sensor, the memory and the input/output, the controller configured to deny device operational change requests received via the input/output based at least in part on the patient specific data sensed by the at least one sensor; and

at least one delivery member under the control of the controller configured to provide a therapeutic function of the medical device.

16. The medical device of claim 15, wherein the controller is further configured to create at least one patient specific interlock based at least in part on the patient specific data sensed by the at least one sensor, the at least one specific interlock used by the controller to deny the specific operational change requests.

17. The medical device of claim 16, wherein the controller is still further configured to create the at least one patient specific interlock based at least in part from external patient specific data received through the input/output.

18. The medical device of claim 15, wherein the controller is further configured to dynamically change the at least one patient specific interlock based on then current patient specific data.

19. The medical device of claim 15, wherein the medical device is a cardiac device and the at least one sensor is at least one electrode configured to measure cardiac electrical activity of a patient'"'"'s heart.

20. The medical device of claim 19, wherein the device operational change requests the controller is configured to deny include at least one of specific pacing rate requests, pacing mode requests, threshold test requests, rates of response requests, tracking mode requests, permanent output setting requests that lose capture, output to super-threshold value requests, requests that effect the longevity of the medical device and symptomatic tracking requests.