Venturi ECG electrode system

Abstract

The present invention provides for an ECG electrode system that includes the use of electrodes adapted to attach to the body via suction. The invention includes a lightweight and compact air pump in combination with air connection hoses, a lightweight air distribution unit, associated electrode tubes, and respective electrodes adapted to be positioned by the Venturi principle, and corresponding electrical leads and recorders / monitors. The electrode leads can each be positioned within respective air connections hoses, e.g., in a manner that is concentric or coaxial with the axis of the connection hoses, in order to both protect the leads themselves and facilitate their positioning.

Description

CROSS REFERENCE TO RELATED APPLICATION [0001] This application is a continuation of prior application Ser. No. 10 / 124,616, filed on Apr. 16, 2002, the entire disclosure of which is incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention generally relates to physiological monitoring electrode systems, also known as electrocardiographs, and to components, including electrodes, for use in such systems. BACKGROUND OF THE INVENTION [0003] Considerable progress has been made in understanding how electrical signals are generated and used within the body. This progress has led to the ability to monitor various medical conditions by means of transferring electrical energy from the body of a patient. This transfer of electrical energy can be accomplished with electrode systems, which use electrodes to contact the skin of the patient and then transfer the electrical energy from the patient to a recording / monitoring device. [0004] Examples of electrode systems inclu...

AI Technical Summary

Benefits of technology

[0023] In a particularly preferred embodiment, the electrode leads are each positioned within respective air connections hoses, e.g., in a manner that is concentric or coaxial with the axis of the connection hoses, in order to both protect the leads themselves and facilitate their positioning.

[0040] For use in such an embodiment, the system of this invention can include, for instance, a suitable vest for use as a secondary electrode stabilization component. Such a vest can be prepared using any suitable material in order to permit it to be both lightweight and comfortable, e.g., a mesh type material having over 90%, or even over 95% open space. One of the major benefits of a system of this type is the reduction of preparation time spent on the patient. Preparation time can be reduced from 10 to 15 minutes for adhesive-based disposable electrodes, only a few seconds for the Venturi based system. Also, as a patient sweats during a typical stress test, disposable adhesive based electrodes have been known to fall off and fail (due to sweat accumulation under the electrode). This problem is alleviated, if not avoided entirely, using the present system, because as skin surface moisture increases, electrical resistance decreases dramatically, and conductivity improves. Additionally, the Venturi based electrodes are non-disposable, which not only helps keep the environment cleaner but also delivers an improved cost-benefit ratio, which can contribute to lower overall healthcare costs. By comparison, adhesive-based disposable electrodes can cost anywhere from $1.25 to $3.50 (a stress test requires a minimum of 10 electrodes) depending on the volume of total tests performed the medical practitioner.

Problems solved by technology

While these adhesive ECG electrode systems can be useful in performing ECG monitoring, there are significant problems associated with them.

First, such a system can result in considerable discomfort for the patient.

This process not only takes time, which adds to the expense of the overall procedure, but is also uncomfortable for the patient and increases the chance of injury and infection.

Further, there are considerable costs associated with the use of these disposable electrodes, including the cost of the electrodes themselves, plus delivery costs, storage costs, and disposal costs.

Second, most adhesive ECG system electrodes are manufactured to be disposable, having some or most of their component parts in plastic form in order to permit the electrodes to be discarded after use, thereby resulting in additional waste and burden on the environment.

Another drawback associated with conventional adhesive ECG systems is the loss of adhesiveness when the electrode is removed from the skin.

Yet another drawback is the risk that the patient might be allergic to the adhesive itself.

Finally, there is the time consuming process of cleaning the adhesive off of the patient's skin after the ECG process is completed.

Although quite simple in operation, such electrodes suffered from the inconsistent vacuum produced.

However, ECG electrode system must typically use low-suction vacuum pumps or reaction pumps, and thereby avoid the use of large suction, which could produce a high risk of a hematoma, leading to a variety of related problems.

The use of low suction, however, increases the chance that electrodes will fall off in the course of use.

This meant the ECG system operator would have to spend valuable time re-adhering the electrodes and this extra time produces extra labor costs.

However, such systems increased the risk that the vacuum might become too strong and thus increase the risk of hematomas.

Another disadvantage of the pump-based ECG systems, as described above, are the difficulties relating to the removal and re-adherence of the electrodes.

A further disadvantage, of both ECG pump systems described above, is that the air flowing towards the pump can carry contamination into the pump system, such as sweat, hair, and electrode paste.

Although filters can be used, the risk of contamination of the system and infection of the patient is not entirely avoided.

Further, the contamination of the pump system requires the system to be cleaned frequently and makes the cleanup of the system extremely difficult.

The problems surrounding the cleanup of the system are also compounded by associated labor costs.

The above-described ECG electrode systems also tend to have drawbacks associated with their design.

Because of their suction pump construction, the US Food and Drug Administration restricts the use of such systems in the United States due to the high possibility of cross-contamination.

These systems are also limited due to their bulkiness.

The fact that the systems must house pumps to generate the suction causes them to be quite heavy.

Further, the acquisition modules or distribution boxes which route the signals to the recorders / monitors can be large and heavy due to the electronics on board which digitize the signals coming form the patient before being routed to the ECG recorder.

This bulkiness causes the systems to be heavy and immobile and therefore reserved for use in one location.

These lead wires are expensive and reputed to break quite often due to their thin design and repeated movement throughout an ECG procedure.

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