Limited use medical probe

• US 7,048,687 B1
• Filed: 02/06/2003
• Issued: 05/23/2006
• Est. Priority Date: 04/14/1999
• Status: Expired due to Fees

• Current Assignee: Masimo Corporation
• Original Assignee: OB Scientific Incorporated
• Inventors: Larsen, Michael T., Bahr, Dennis E., Reuss, James L., von der Ruhr, Gerhard
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/361,167
• Time in Patent Office: 1,202 Days
• Field of Search: 600/300, 600/325, 600/338, 600/588, 600/639, 600372-377, 705/2, 705/29
• 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 method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

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

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory;

(g) retrieving and storing the identifying data about the medical probe from the probe memory, and storing the data in a memory component of the medical device;

(h) storing a time and date stamp of the use of the medical probe memory in a memory component of the medical device;

(i) comparing the identifying data about the medical probe, read from the probe memory, with the identifying data and time and date stamp of the use(s) corresponding to a previously coupled medical probe(s) as stored in the medical device memory; and

including determining whether an interrupted usage of the medical probe has resumed, or a new usage of the medical probe has begun.

2. The method as defined in claim 1, wherein Step (e), the security function includes a physical security method, or an algorithmic security method, or both.

3. The method as defined in claim 2, wherein the physical security method includes a portion of the probe memory that is a write-once memory device.

4. The method as defined in claim 2, wherein the algorithmic security function 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

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;

or in both.

5. The method as defined in claim 4, wherein the data encoding system incorporates symmetrical encryption or wherein the data encoding system incorporates asymmetrical encryption.

6. The method as defined in claim 5, wherein the data encoding system incorporates public key encryption.

7. The method as defined in claim 1, wherein the probe memory contains the set of usage criteria.

8. The method as defined in claim 1, further comprising the step of retrieving the set of usage criteria from the probe memory.

9. The method as defined in claim 1, wherein the Step (f) set of usage criteria includes one or more of the following:

a) a duration of use of the medical probe in conjunction with the medical device or other medical devices;

or

b) a count of the number of uses of the medical probe in conjunction with the medical devices or with the other medical devices;

or

c) an elapsed time since manufacture or reprocessing of the medical probe.

10. The method as defined in claim 1, wherein Step (f), the expiration response includes one or more of the following steps:

a) displaying a message indicating that a new medical probe is required;

or

b) modifying the medical probe to disable a therapeutic function(s) and/or a monitoring function(s) of the medical probe after the present use;

or

c) immediately disabling the therapeutic and/or monitoring function(s) of the medical device related to the medical probe.

11. The method as defined in claim 10, wherein Step 47b, further comprises the step of causing a fuse or fusible link in the circuitry of the medical probe to open, thereby disabling the therapeutic and/or monitoring function(s) of the medical probe.

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

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

14. A method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

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

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory;

(g) storing a time and date stamp of the use of the medical probe memory in the probe memory, and storing identifying data about the medical device in the probe memory; and

(h) comparing the stored medical device identifying data, read from the memory component of the medical device, to identifying data and time and date stamp of use(s) corresponding to previously coupled medical device(s) as read from the probe memory; and

including determining whether an interrupted usage of the medical probe with the medical device has been resumed, or a new usage of the medical probe has begun.

15. A method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

(e) using a security function to verify that the contents of the probe memory have not been corrupted or tampered with; and

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory;

(v) (performing an auto identification function, including comparing the medical probe type, the medical device, a patient, and a mode of operation of the medical device to verify that the mode of operation of the medical device is permitted when applying the medical probe to the patient.

16. A method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

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

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory; and

(g) storing a functional test sequence in the probe memory;

storing a set of function test results in the probe memory;

activating the medical probe to perform the functional test sequence and gathering results of the functional test sequence;

comparing results of the functional test sequence with the stored set of function test results and reporting the results of the functional test sequence.

17. A method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

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

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory; and

(g) storing identifying information and demographic information about the patient coupled to the medical probe in the probe memory.

18. A method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

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

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory; and

(g) storing a set of therapeutic and monitoring results associated with the patient in the probe memory.

19. A method for limiting the use of a medical probe according to a set of usage criteria using a security function, the method comprising the following steps:

(a) coupling a probe memory to a medical probe, the probe memory having an identifying data about the medical probe, therein;

(b) coupling the medical probe to a medical device;

(c) coupling the medical probe to a patient;

(d) retrieving a set of use values associated with use of the medical probe from the probe memory;

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

(f) applying a set of usage criteria periodically during use of the medical probe, comprising repetition of the following steps;

(i) updating the set of use values of the medical probe during use and creating an updated set of use values;

(ii) testing the updated set of use values against the set of usage criteria related to the medical probe;

(iii) performing an expiration response when one or a combination of the usage criteria are violated;

(iv) storing the updated set of use values on a periodic basis in the probe memory; and

(g) transmitting a query signal from the medical device to the medical probe and waiting for an acknowledge signal from the medical probe device prior to beginning the therapeutic or monitoring function of the medical probe.