Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
1999-08-20
2001-02-06
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
Reexamination Certificate
active
06183421
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a connector set that joins a gas column catheter to a pressure transducer airway in a manner that injects air into the catheter's bladder. The connectors ensure that the catheter is operable for no more than a single use.
2. Description of the Prior Art
Air column catheters have certain attributes that make them especially useful in measuring pressure in the body including natural body passageways such as the urethra or esophagus. These catheters may have a single bladder or a plurality of bladders, each of which is in communication with a dedicated pressure transducer. The bladder of an air column catheter can function for extended periods. It is therefore possible to use a gas column pressure-monitoring catheter in more than one patient. Reuse is not advisable, however, since a bladder will eventually fail and may do so in a manner that affects the accuracy of the pressure reading and the proper treatment of the patient. Consequently, there is a need to limit the use of an air-based catheter to a single patient.
There is little incentive to reuse most air column catheters that measure pressure in the body. Either the risk of infection is too great to justify reuse or the catheter has structural elements that make cleaning and resterilization quite difficult. Concern for infection is much less in the case of catheters introduced through natural body orifices such as the esophagus or the urethra. There is an economic incentive to reuse the catheter even though the manufacturer specifies that it is designed for single use. Reuse can lead to an uncontrolled situation where there is no awareness of the number of times the catheter has been reused. At some point, the bladder will leak and the catheter will no longer function properly. Since the leak may be small, it may not be obvious that the catheter is incapable of correctly reading pressure. If the observed pressure is incorrect, the patient may be mistreated based on invalid pressure values. The risk of bladder failure is proportional to the number of bladders on the catheter. For example, a urethra catheter may have two bladders on a measuring catheter and one on a separate reference catheter. A esophageal catheter may have four to six bladders.
U.S. Pat. No. 5,573,007 (Bobo) describes a connector and transducer housing that, when coupled, automatically injects air into a bladder of an air column catheter so as to make it operative.
SUMMARY OF THE INVENTION
The primary object of the connector system described in the present invention is to limit the use of a catheter to a single patient and thereby insure that the data obtained is accurate and valid for proper management of the patient. The invention is applicable to a system wherein the connection of the catheter to a transducer housing automatically injects air into the bladder of the pressure measuring system.
A related object of the present invention is to disable the mechanism used to inject air into the bladder at the same time as injecting air into the bladder for a single use, thereby preventing reuse.
In brief, the present invention describes a connector set that joins the lumen of an air column catheter to a transducer housing. When first joined, the connector set automatically injects into the bladder an amount of air required for proper function of the bladder. At the same time, the connector set disables the mechanism used to inject air into the bladder and thereby limits the catheter to single patient use. The catheter connector provides an air vent to the ambient environment. The vent is closed by a pierceable seal. The transducer housing connector contains a piercing element that penetrates the vent seal when the connectors are mated. Though pierced, the vent seal retains its ability to prevent loss of air through the vent for the expected operating life of the catheter. Once the catheters are separated, the seal is irreparably breached. Should a second use be attempted, the breached seal allows gas that would otherwise be injected into the bladder to escape to the atmosphere. The bladder at this point can no longer be charged with gas and is unable to retain air pressure. The catheter cannot therefore be used a second time to couple pressure in the environment to a pressure transducer.
The advantage of the present invention is that the pressure monitoring system is limited to a single use on one patient and not able to be reused on other patients, thereby eliminating the risk of endangering the health of patients by failure and false readings common to such devices when they arc used repeatedly.
REFERENCES:
patent: 5573007 (1996-11-01), Bobo
patent: 5951497 (1999-09-01), Wallace et al.
patent: 6024704 (2000-02-01), Meador et al.
Hindenburg Max
Szmal Brian
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