Apparatus and method to limit the life span of a diagnostic...

Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation

Reexamination Certificate

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Reexamination Certificate

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06270460

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to an improvement in diagnostic medical ultrasound imaging, and more specifically to an improved system, method, and ultrasound probe for limiting the usage of the ultrasound probe, after a predetermined time of usage or number of usages of the ultrasound probe.
2. Description of the Prior Art
There is growing interest in ultrasound systems for medical applications. Commonly available ultrasound systems for medical applications normally use ultrasound probes with a one-dimensional (1-D), 1.5-D, or 2-D ultrasound transducer array for obtaining images.
Major applications for imaging with diagnostic medical ultrasound frequently require the insertion of an ultrasound probe into a human body for improved imaging. Therefore, some medical ultrasound probes are designed for only one use. This is because the ultrasound probes come into contact with bodily fluids, such as blood, saliva or bile. Re-use of the ultrasound probe carries the possible risk of cross contamination between patients, i.e., HIV, various types of hepatitis, and other diseases spread by bodily fluid contact.
Because these ultrasound probes are designed for only one use, each ultrasound probe must be relatively inexpensive in manufacturing and materials cost for medical cost-effectiveness. Therefore, these ultrasound probes do not generally have the rugged construction of the more expensive re-usable ultrasound probes.
These ultrasound probes are designed to be delivered to the customer pre-sterilized and tested. Therefore, the ultrasound probe materials are chosen to be suitable for a specific form of factory sterilization. This means the materials used may not be suitable for other sterilization techniques commonly used in hospitals, such as radiation, various chemical treatments, etc. If an ultrasound probe is subjected to a sterilization technique for which it was not designed, the ultrasound probe may degrade, e.g., a leakage current fault may occur, or a breakdown may occur in one of the insulating sleeves. If such an ultrasound probe is re-used, patient safety is severely compromised. And if a fault should occur in the ultrasound probe due to improper sterilization techniques, it is not easy to verify the electrical integrity of the ultrasound probe. Because the ultrasound probe is designed for one time use only, the ultrasound probe manufacturer normally supplies no means to enable customer verification of the electrical integrity of the ultrasound probe.
Therefore, misuse of an ultrasound probe can be dangerous to patients and an ultrasound probe manufacturer is legally liable in many jurisdictions for the foreseeable, abnormally dangerous misuse of an ultrasound probe. Therefore, there is a need for an improved system, method, and ultrasound probe to limit the life span of the ultrasound probe. What is also needed is a low cost system and method for identifying an ultrasound probe, for indicating the number of times the ultrasound probe has been used, or for indicating the amount of time the ultrasound probe has been in use.
SUMMARY OF THE INVENTION
One object of the present invention is to provide a system, method, and ultrasound probe to limit the life span of the ultrasound probe.
Another object of the invention is to provide a low cost system and method for identifying an ultrasound probe, for indicating the number of times the ultrasound probe has been used, or for indicating the amount of time the ultrasound probe has been in use.
A first aspect of the invention is directed to an ultrasound probe that includes an ultrasound transducer and a circuit having a plurality of states to limit the use of the ultrasound probe.
A second aspect of the invention is directed to an ultrasound system that includes an ultrasound probe with a plurality of states, a circuit to program the states of the ultrasound probe and receive state data from the ultrasound probe and interpret the state data, and a cable to communicate state data between the ultrasound probe and the circuit.
A third aspect of the invention is directed to a method for using a limited use ultrasound probe, including the steps of determining the state of a circuit in the limited use ultrasound probe and determining if the ultrasound probe can be used.


REFERENCES:
patent: 4868476 (1989-09-01), Respaut
patent: 5487386 (1996-01-01), Wakabayashi et al.
patent: 5731716 (1998-03-01), Pascucci
patent: 5804162 (1998-09-01), Kabalnov et al.
patent: 6029083 (2000-02-01), Flower et al.

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