METHOD AND KIT FOR MAINTAINING A STERILE ENVIRONMENT DURING CALIBRATION OF A MEDICAL DEVICE

• US 20080307854A1
• Filed: 06/18/2007
• Published: 12/18/2008
• Est. Priority Date: 06/18/2007
• Status: Active Grant

• Current Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Kraus, Robert G.
• Granted Patent: US 7,827,845 B2
• Time in Patent Office: Days
• US Class Current: 73/1.57
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01K 13/00 Thermometers specially adapted for specific purposes
• CPC Class Codes: G01L 27/002 Calibrating, i.e. establishing true relation between transducer output value and value to be measured, zeroing, linearising or span error determination

Abstract

A method for maintaining a medical device in a sterile atmosphere at a desired temperature during a calibration step is provided. The method includes packaging a medical device and temperature indicator in a sterile container such that the indicator is visible to a user. Next, heat can be applied to the container in order to stabilize the temperature of the container (as indicated by the encased temperature indicator) at room temperature. Once at room temperature, the device can be calibrated while remaining in the sterile atmosphere. A kit including such a container and a set of instructions is also provided. Like above, the container of the kit can include a sterile medical device and temperature indicator such that the device can be maintained in a sterile environment during calibration and/or zeroing. As such, the method and kit allow for increased precision and safety in performing medical procedures.

Claims

1. A method for calibrating a medical device, comprising:

packaging a temperature indicator adjacent to a medical device within a sterile container such that the temperature indicator can determine and indicate a current temperature of the medical device, the temperature indicator capable of being visualized by a user through a clear portion of the sterile container;

applying a heat to the sterile container until the temperature indicator indicates a desired temperature; and

calibrating the medical device at the desired temperature.

2. The method of claim 1, further comprising:

removing the medical device from the container; and

performing a desired procedure with the medical device.

3. The method of claim 2, wherein the medical device is a sensor.

4. The method of claim 3, wherein the sensor is selected from the group consisting of:

a temperature sensor, an oxygen sensor, and a pH sensor.

5. The method of claim 1, wherein the medical device is an implantable pressure sensor capable of measuring an intra-ventricular pressure.

6. The method of claim 5, wherein the implantable pressure sensor is calibrated at body temperature immediately before implanting the sensor in a patient'"'"'s skull.

7. The method of claim 6, wherein the temperature indicator is a microencapsulated liquid crystal temperature indicator.

8. The method of claim 7, wherein the temperature indicator can detect and indicate a temperature change of about 0.5°

C.

9. The method of claim 8, wherein the temperature indicator includes an adhesive layer capable of securing the temperature indicator at a desired position.

13. The kit of claim 11, wherein the sensor is an implantable pressure sensor.

14. The kit of claim 13, wherein the implantable pressure sensor is capable of determining an intra-ventricular pressure.

15. The kit of claim 14, wherein the temperature indicator includes microencapsulated liquid crystal technology.

16. The kit of claim 15, wherein the temperature indicator can change from a first color to a second color in response to a temperature change of about 0.5°

C.

17. The kit of claim 15, wherein the temperature indicator can change from a first color to a second color in response to a temperature change in the range of about 0.5°

C. to about 2.0°

C.

18. The kit of claim 15, wherein the temperature indicator includes an adhesive layer capable of securing the temperature indicator at a desired position adjacent the medical device.

10. A kit, comprising:

a sterile container housing a medical device and a temperature indicator, the temperature indicator being positioned relative to the medical device such that the temperature indicator is capable of indicating a present temperature of the medical device, the temperature indicator further being positioned within the sterile container such that the indicator is visible to a user through a clear portion of the sterile container; and

instructions on how to use.

11. The kit of claim 10, wherein the medical device is a sensor.

12. The kit of claim 11, wherein the sensor is selected from the group consisting of:

a pressure sensor, a temperature sensor, an oxygen sensor, and a pH sensor.