Digital pen to capture data in ambulatory monitored patients

• US 8,000,532 B2
• Filed: 03/05/2007
• Issued: 08/16/2011
• Est. Priority Date: 02/28/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Van Hove, Jos W., Boute, Willem
• Primary Examiner(s): MARIAM, DANIEL G
• Application Number:
  US11/681,864
• Publication Number:
  US 20080208007A1
• Time in Patent Office: 1,625 Days
• Field of Search: 382187-189, 382/305, 382/314, 382/151, 705 2- 5
• US Class Current: 382/187
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G06F 3/03545 Pens or stylus
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A medical device system and method for monitoring a patient include a monitoring device for storing data relating to the patient and a digital pen for digitizing and storing data handwritten by the patient. A control module is configured to aggregate data stored by the monitoring device and handwritten data stored by the digital pen.

Claims

1. A medical device system, comprising:

a monitoring device for storing data relating to a patient;

a digital pen for digitizing and storing data handwritten by the patient with the digital pen and having a real-time clock for logging the time and date of the data that has been digitized; and

a control module configured to aggregate data stored by the monitoring device and handwritten data stored by the digital pen, wherein the aggregation of the data stored by the monitoring device and the handwritten data stored by the digital pen includes chronologically aligning the handwritten data with the monitored device data based on the time and date stamp.

2. The medical device system of claim 1 wherein the digital pen comprises an image capture module for capturing an image of handwritten data.

3. The system of claim 2 further comprising a paper for use with the digital pen, the paper being formatted in at least one area for recognition of medical data using at least one unique identifier preprinted on the paper.

4. The system of claim 3 wherein the at least one unique identifier corresponds to a patient symptom.

5. The system of claim 3 wherein the control module being programmable and the at least one unique identifier being programmably assigned to a medical parameter.

6. The system of claim 5 wherein programmably assigning the unique identifier includes capturing handwritten data corresponding to the medical parameter.

7. The medical device system of claim 1 wherein the digital pen comprises a data conversion module for converting digitized data to a character encoded format.

8. The medical device system of claim 1 wherein the digital pen comprises a communication module configured for bidirectional communication with the control module for transferring the stored handwritten data to the control module.

9. The system of claim 8 wherein the monitoring device comprises a communications module configured for bidirectional communication with the digital pen and wherein the monitoring device being configured to store data in response to receiving a signal from the digital pen.

10. The system of claim 8 wherein the monitoring device comprises a communications module configured for bidirectional communication with the digital pen and further comprises a therapy delivery module responsive to handwritten data received from the digital pen.

11. The system of claim 1 wherein the monitoring device comprises a sensor for sensing a physiological signal and the data stored by the monitoring device includes physiological signal data.

12. The system of claim 1 wherein the monitoring device comprises a therapy delivery module and the data stored by the monitoring device includes therapy delivery data.

13. The system of claim 1 wherein the monitoring device being configured to perform device diagnostic tests and the data stored by the monitoring device includes device-related diagnostic data.

14. The system of claim 1 wherein the monitoring device being an implantable medical device.

15. The system of claim 14 further comprising an external device, the external device including an external communication module;

wherein the control module being included in the external device;

wherein the implantable medical device comprises an implantable communications module in communication with the external communication module for transmitting the stored data to the control module and the digital pen comprises a communication module in communication with the external device for transferring the stored handwritten data to the control module.

16. The system of claim 1 wherein the control module being included in the monitoring device.

17. The system of claim 1 further comprising a networked central database and wherein the control module being in communication with the networked central database and configured to transfer aggregated data to the networked central database.

18. A method for monitoring a patient, comprising:

digitizing data handwritten by the patient using a digital pen;

using a real-time clock for logging the date and time of the data that has been digitized;

storing data acquired by a monitoring device, and

aggregating the handwritten data with the stored data, wherein aggregating the handwritten data with the stored data includes chronologically aligning the handwritten data with the monitored device data based on the time and date stamp.