Limited use medical probe

• US 6,308,089 B1
• Filed: 04/14/1999
• Issued: 10/23/2001
• Est. Priority Date: 04/14/1999
• Status: Expired due to Term

• Current Assignee: Masimo Corporation
• Original Assignee: OB Scientific Incorporated
• Inventors: Larsen, Michael T., von der Ruhr, Gerhard, Bahr, Dennis E.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/291,769
• Time in Patent Office: 923 Days
• Field of Search: 600/588, 600/639, 600/325, 600/338, 600/372-377
• US Class Current: 600/338
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• 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 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 8/00 Diagnosis using ultrasonic, sonic or infrasonic waves imaging of objects using sonar G01S15/00

Abstract

A limited use medical probe is disclosed. The medical probe includes a memory storage component for maintaining a use value, representing either the number of uses and/or the duration of use of the medical probe. The medical probe is coupled to a medical monitoring device which prevents the performance of monitoring functions when the number of uses or the total duration of use reaches a predetermined threshold value, thereby preventing overuse of the probe.

Claims

1. A method for limiting the use of a medical probe to a threshold use value, the method comprising the following steps:

coupling a memory storage component to a medical probe;

coupling the medical probe to a medical monitoring device;

coupling the medical probe to a patient;

retrieving a use value associated with use of the medical probe from the memory storage component;

decrypting stored data to verify that the use value has not been corrupted or tampered with;

updating the use value of the medical probe during use; and

disabling monitoring functions when the use parameter is substantially equivalent to the threshold use value.

2. The method as defined in claim 1, wherein the decrypted stored data is a serial number identifying the fetal sensor device.

3. The method as defined in claim 1, wherein the decrypted stored data is the use value.

4. A method for limiting the use of a medical probe to a threshold use value, the method comprising the following steps:

coupling a memory storage component to a medical probe;

coupling the medical probe to a medical monitoring device;

coupling the medical probe to a patient;

monitoring a use value of the medical probe;

disabling monitoring functions when the use parameter is substantially equivalent to the threshold use value;

storing identifying information in the memory storage of the medical probe; and

encrypting the identifying information stored in the medical probe, transmitting the encrypted serial number to the monitoring device, and decrypting the serial number in the monitoring device.

5. The method as defined in claim 4, further comprising the step of displaying a message indicating that a new medical probe is required.

6. The method as defined in claim 4, further comprising the step of storing identifying information in a memory storage of the medical monitoring device.

7. The method as defined in claim 6, further comprising the steps of using the stored identifying information to verify the identity of the medical monitoring device.

8. The method as defined in claim 4, further comprising the step of storing a time and date stamp in the medical probe.

9. The method as defined in claim 4, further comprising the step of storing a time and date stamp and the identifying information in the monitoring device.

10. The method as defined in claim 4, further comprising the steps of transmitting a query signal from the monitoring device to the medical probe and waiting for an acknowledge signal from the medical probe device prior to beginning a medical monitoring process.

11. The method as defined in claim 4, wherein the threshold use value comprises a duration of use of the probe in conjunction with a medical device.

12. The method as defined in claim 4, wherein the threshold value is a count of number of uses of the probe in conjunction with a medical device.

13. The method as defined in claim 4, wherein a public key encryption system is used to encrypt and decrypt the transmitting serial number.

14. A limited use fetal sensor device comprising:

a housing;

at least one sensor device; and

a token chip card including a communications port, the token chip card storing a use value for limiting the use of the probe to a predetermined threshold value.

15. A medical monitoring system comprising:

a medical probe including at least one sensor, a memory storage component, a communications port, a sensor, and a probe connector, wherein the memory storage component includes a use value for limiting a usage of the medical probe, a serial number identifying the medical probe and at least one encryption key; and

a monitoring device including a monitor connector, a controller, a memory storage device storing a serial number identifying the monitoring device and at least one encryption key, and a communications port, wherein the monitoring device limits the usage of the medical probe to a predetermined threshold value.

16. The medical monitoring system as defined in claim 15, wherein the medical probe is a fetal sensor.

17. The medical monitoring system as defined in claim 15 further comprising a display coupled to the monitoring device.

18. The medical monitoring system as defined in claim 17, wherein the display provides alphanumeric messages relating to the use value or the use threshold.

19. A method for verifying the identity of components of a medical monitoring system to prevent tampering with stored data:

storing a serial number, an encryption key, and at least one medical monitoring parameter in a memory storage component of a medical probe;

storing a serial number and an encryption key in a memory storage component of a medical monitoring device;

coupling the medical probe to the medical monitoring device,

encrypting the serial number stored in the medical probe, transmitting the encrypted serial number to the medical monitoring device, and decrypting the serial number in the medical monitoring device;

verifying the identity of the medical monitoring device through the decrypted data;

allowing the medical monitoring device to access the medical monitoring parameter if the identity of the medical monitoring device is verified; and

preventing the medical monitoring device from accessing the medical monitoring parameter if the identity of the monitoring device is not verified.

20. The method as defined in claim 19, wherein the medical monitoring parameter is a use value.

21. The method as defined in claim 19, further comprising the step of storing the medical monitoring parameter in a non-erasable memory component to prevent erasure.

22. The method as defined in claim 21, wherein the memory component is an EPROM.

23. The method as defined in claim 19, wherein the medical monitoring parameters include a use value and a threshold value.

24. A method for maintaining a history of the use of a medical probe, the method comprising the following steps:

storing a serial number identifying the medical probe in a memory component of the medical probe;

storing a date and time stamp in the memory component of the medical probe;

storing the identity of a medical worker associated with a procedure and storing the identity of the medical worker in the memory component of the medical probe;

storing patient data in the medical probe; and

retrieving the stored information to provide a history of a medical procedure.

25. The method as defined in claim 24, further comprising the steps of coupling the medical probe to a medical monitoring device, storing the serial number of the medical monitoring device in a memory component of the medical probe, and storing a serial number identifying the medical probe in the medical monitoring device.

26. The method as defined in claim 25, further comprising the step of storing the date and time stamp in the medical probe.

27. The method as defined in claim 25, further comprising the step of storing the identity of the medical worker in the medical probe.

28. The method as defined in claim 25, further comprising the step of storing the patient data in the medical probe.

29. The method as defined in claim 25, further comprising the steps of coupling a medical probe to the medical monitoring device, transmitting a serial number identifying the medical probe to the medical monitoring device, storing the serial number identifying the medical monitoring device in the medical probe, storing the patient data, medical worker identity, and patient data in the medical probe as a cross check of the data in the medical monitoring device.

30. The method as defined in claim 25, further comprising the step of encrypting at least one of the serial number of the medical monitoring device and the serial number of the medical probe to prevent tampering.

31. A limited use fetal sensor device comprising:

a housing;

at least one sensor device; and

a memory storage component storing a protected use value for limiting the use of the probe to a predetermined threshold value, wherein the memory storage component further includes a medical history of the use of the fetal sensor device.

32. The fetal sensor device as defined in claim 31, wherein the memory storage component includes an encrypted serial number identifying the fetal sensor device.

33. The fetal sensor device as defined in claim 31, wherein the memory storage component further includes an encrypted serial number of each of a plurality of medical devices to which the fetal sensor device has been connected.

34. A medical monitoring system comprising:

a medical probe including at least one sensor, a token card chip, a communications port, a sensor, and a probe connector, wherein the token card chip includes a use value for limiting a usage of the medical probe and a serial number identifying the medical probe; and

a monitoring device including a monitor connector, a controller, a memory storage device storing a serial number identifying the monitoring device, and a communications port, wherein the monitoring device limits the usage of the medical probe to a predetermined threshold value.