Limited use medical probe

• US 20060161054A1
• Filed: 03/02/2006
• Published: 07/20/2006
• Est. Priority Date: 04/14/1999
• Status: Abandoned Application

• Current Assignee: Masimo Corporation
• Original Assignee: Masimo Corporation
• Inventors: Bahr, Dennis E., Larsen, Michael T., Reuss, James L., von der Ruhr, Gerhard
• Application Number:
  US11/366,617
• Publication Number:
  US 20060161054A1
• Time in Patent Office: Days
• US Class Current: 600/300
• 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, including a memory for maintaining a use value. The medical probe is coupled to a medical device that inhibits its function when the use value reaches a predetermined threshold value, preventing improper use of the probe. The probe memory may also store identification, usage, and clinical data. A probe auto-identification function, a probe re-identification function and a probe functional test sequence are disclosed for the medical probe. After use, a reprocessing step may reset the probe memory, permitting further probe use.

Claims

1. A medical probe for use with a medical device, the medical probe comprising:

a sensor or an effector;

a probe communications port for communicating and transferring data between the medical probe and the medical device;

a probe memory having data stored therein for facilitating a security function and one or more other functions, including a probe auto-identification function, a probe re-identification function, or a probe functional test sequence, when the medical probe is used in conjunction with the medical device; and

wherein the probe memory further includes a reuse authorization function for reprocessing the medical probe.

2. The medical probe as defined in claim 1, wherein the probe re-identification function utilizes an identifying data about the medical probe, and a time and date stamp of a last use of the medical probe, a current date and time, and both an identifying data and a time and date stamp of use corresponding to the previously used medical probe stored in the medical device.

3. The medical probe as defined in claim 1, wherein the probe memory includes a set of probe identifying data and the medical device includes a probe auto-identification function utilizing the probe identifying data.

4. The medical probe as defined in claim 1, wherein the probe functional test sequence of the medical device activates the medical probe to verify functionality of the sensor or the effector of the medical probe.

5. The medical probe as defined in claim 1, wherein the security function is in the medical probe or in the medical device or in both.

6. The medical probe as defined in claim 1, wherein the security function includes a physical security method, or an algorithmic security method, or both.

7. The medical probe as defined in claim 6, wherein the physical security method includes a portion of the probe memory having a write-once memory.

8. The medical probe as defined in claim 6, wherein the algorithmic security method includes a data encoding system with encryption in the medical device for encrypting data before it is stored in the probe memory and for decrypting data read from the probe memory in the medical device;

or wherein the algorithmic security method includes a data encoding system with encryption in the medical probe for encrypting data from the medical device in the probe memory when it is stored therein, and for decrypting data stored in the probe memory when it is read by the medical device.

9. The medical probe as defined in claim 8, wherein the data encoding system incorporates symmetrical encryption or wherein the data encoding system incorporates asymmetrical encryption.

10. The medical probe as defined in claim 8, wherein the data encoding system incorporates public key encryption.

11. The medical probe as defined in claim 1, wherein the medical probe is a pulse oximetry sensor.

12. The medical probe as defined in claim 1, wherein the medical probe is a fetal sensor probe.

13. The medical probe as defined in claim 12, wherein the fetal sensor probe is a limited use fetal sensor probe including a housing and at least one sensor device and wherein the probe memory includes the probe communications port, the probe memory storing a set of use values for limiting use of the probe according to a set of usage criteria.

14. The medical probe as defined in claim 13, wherein the sensor device is a pulse oximetry sensor used for measuring oxygen saturation in fetal tissue.

15. The medical probe as defined in claim 13, wherein the probe memory comprises an add-only memory device.

16. A medical reprocessing system comprising:

a medical reprocessor; and

a medical probe having a sensor or an effector, a probe communications port and a probe memory having a security function and a reuse authorization function for reprocessing the medical probe.

17. The medical reprocessing system as defined in claim 16, wherein the medical reprocessor includes a controller, a medical processor memory, a reprocessor communications port, a functional tester and an external connection configured to communicate with the medical probe and to receive from the medical probe a set of use values for determining whether the medical probe should be disabled or reprocessed for re-use using the reuse authorization function.

18. A method for reprocessing a medical probe in a medical reprocessing system having a medical reprocessor, the medical probe having a probe memory with a reuse authorization function therein for reprocessing the medical probe, the method comprising the steps of:

(a) coupling the medical probe to the medical reprocessor in the medical reprocessing system;

(b) using the reuse authorization function for seeking authorization to reprocess the medical probe; and

(c) disabling the medical probe, if the reuse authorization fails;

or clearing the probe memory and storing new contents therein to permit further use of the medical probe, if the reuse authorization is successful.

19. The method for reprocessing a medical probe as defined in claim 18, wherein the medical reprocessing system includes an external connection, the method including the step of remotely performing Steps (b) through (c) via the external connection.

20. The method for reprocessing the medical probe in the medical processing system as defined in claim 18, wherein the medical reprocessor includes a controller, a medical processor memory, a reprocessor communications port, and a function tester;

and wherein the medical probe includes a sensor or an effector and a probe communications port, and wherein the probe memory includes a security function and the reuse authorization function therein, the method further comprising the steps of;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory through the reprocessor communications port in communications with the probe communications port after Step (a);

(e) using the security function for decrypting data stored in the probe memory to verify that a contents of the probe memory have not been corrupted or tampered with;

(f) using the controller to perform a set of function tests on the medical probe using the function tester;

and wherein Step (c) further includes disabling the medical probe, if any of the function tests fail;

or wherein Step (c) further includes clearing the probe memory and storing new contents therein to permit further use of the medical probe if the function tests and the reuse authorization are successful.