WO1999029369A1

WO1999029369A1 - Adapter for medical pulse generators and electrode pads

Info

Publication number: WO1999029369A1
Application number: PCT/US1998/026193
Authority: WO
Inventors: Eleanor L. Schuler; David Dodd; Munawar M. Merza
Original assignee: Cpr Medical, Inc.
Priority date: 1997-12-09
Filing date: 1998-12-09
Publication date: 1999-06-17
Also published as: AU1813199A

Abstract

This invention is a method, and apparatus for adapting a variety of medical pulse generator (6) outputs to a variety of cardiac electrode pad (2) inputs. The adapter (10) allows the available medical pulse generator (6) to be used in conjunction with the available cardiac electrode pads.

Description

ADAPTER FOR MEDICAL PULSE GENERATORS AND ELECTRODE PADS

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing of U.S. Provisional Patent Application Serial No. 60/068,152, entitled Cardiac Electrode Pad Interlink Connector Set, filed on December 9, 1997, and the specification thereof is incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention (Technical Field):

The present invention relates to medical devices used in controlling the heart muscle of people or animals and the connection of such devices to the electrode pads which deliver electrical signals to a heart.

Background Art:

Perhaps 40% of heart attack victims are in fibrillation when a paramedic arrives. Another 40% might be in bradycardia, tachycardia or asystolic status. The other 20% might have plugged heart blood vessels, bleeding to death or other conditions that are not related to the electrical function of the heart muscle. Fibrillation is a quivering, pulsating or erratic weak contractions of the heart. Inadequate blood is being pumped and death is usually certain if nothing is done. An arrhythmia is any abnormal electrical and/or mechanical contraction of the heart. An asystole is when there is no beat at all or a "flat-line" on the monitor. Bradycardia is a slow beat, less than 60 beats per minute, and tachycardia is a fast beat, over 100 beats per minute. And, mechanical disconnection is the reading of an electrical signal in the heart but it does not "mechanically" or "physically" cause a contraction. So for heart to beat it requires electrical pulse into contractile cells that "respond" by contracting. During fibrillation less or no blood is circulating and thus all systems of the human or animal body are at risk. The longer fibrillation continues unchecked the more likely death will occur. During fibrillation the electrical system of the heart is disorganized and erratic. The normal rhythmic beat is totally lost and electrical failure begins. Shortly the inadequate circulation of blood causes organs and tissues to be oxygen-starved and cell death begins. When brain and heart muscle oxygen starvation reaches crisis points they begin to die and hence the entire body begins to die. At some point the heart fibrillations are not reversible and death of the human or animal occurs. It is important to stop fibrillation and to restart normal heart contractions to oxygenate the entire body properly. The transport of people by ambulance from where they have had a heart attack requires fast action. Survivability decreases ten percent every minute that a heart is not circulating adequate blood to itself and the critical organs of the human or animal body. If there is no blood circulation for ten minutes death almost surely results in humans or animals.

Fibrillation is currently treated by an electronic defibrillator which delivers a shock via two hand-held paddles, or electrode pads, to override an impaired human or animal heart electrical system and to provide a life sustaining heart beat. The electrode pads are applied to humans or animals on the shaved or bare skin at prescribed locations on the chest and/or the chest & back between the scapula and spinal column in various positions depending on the equipment recommendations on the proper use of that specific medical product. This process is familiar to those who view medical television shows and witness a shock so great that the entire body jumps. This shock is usually between 2000 to 5600 volts. The popular conception is that a defibrillator "puts" a heart beat into a stopped heart. This is not true! Actually a defibrillator stops the quivering heart - after which, but not always, the heart may resume a slow beat (bradycardia). Paramedics then can use medications to speed up the heart and/or administer an emergency external pacemaker, also a medical pulse generator, to keep blood circulating while transporting the victim to a hospital. Both defibriilators and external (non invasive) pacemakers require electrode pads with electrically conductive leads which plug into the pulse generators. Many different makes and models of medical pulse generators exist and they use different kinds of electrical connectors to transfer the therapeutic electrical pulse to stick-on (hands-free) or hand-held electrodes. Usually there are two electrodes but in the future up to four electrodes may be used. A difficulty arises when the medical personnel treating a patient's heart condition are not equipped with the appropriately adapted electrode pads to the defibrillator they are using. The present technology does not account for the differences between various manufacturers' models of defibrillators and the electrode pads through which the defibrillators deliver the voltage to the patient. Currently, there are about sixteen producers worldwide of cardiac emergency equipment with about five of them dominating the marketplace.

Currently medical personnel must be sure to carry the appropriate electrode pads that fit to the defibrillator or pacemaker they have to use or else they will not be able to deliver the potentially life- saving voltage to the heart. For example, an ambulance may be administering voltage to the heart of a patient and upon arrival at an emergency room find that a different type of defibrillator and electrode pads are available, or that the ambulance and emergency room must keep their respective equipment. These situations can become frantic. When this happens the patient might be disconnected from one unit and re-connected to another, a potentially life-threatening situation. The removal of one type of electrode pads to be replaced with another is very dangerous not only because of the temporary disconnection from the medical pulse generator but because the positioning of the electrode pads is critical. And, if the patient should go into fibrillation, asystole, or other aberrant beating pattern during this time, they may need to be defibrillated again, which is always a dangerous procedure for both the patient and medical personnel. Removal of the electrode pads should always be avoided.

If merely the connectors could be switched from, for example, the ambulance defibrillator to the hospital unit, then the patient would be exposed for only one to two seconds to non-therapy rather than, for example, one minute. It is known that about 200 millionths of a second might be enough time for a reentrant aberrant waveform to emerge within the myocardium if no pulsing is being performed. But in pacing, which is how most patients that were reached in time, would be arriving at the hospital, it would be expected that one or two seconds of interrupted pacing may not present much risk.

The present invention relates to the space between medical pulse generators, which provide pacing, defibrillation or counter-fibrillation, and human or animal electrode pads. By use of the present invention's adapter it is possible to attach various makes and models of electrode pads to various makes and models of electrical pulse generating equipment. The adapter is specifically designed for given types of medical pulse delivery equipment used for generating various kinds of pulses to perform cardiac resuscitation on humans or animals. Currently no such adapter is known to exist in the prior art.

SUMMARY OF THE INVENTION (DISCLOSURE OF THE INVENTION)

The present invention is an adapter for adapting a variety of medical pulse generators to a variety of cardiac electrode pads. In a first embodiment the adapter has an input which connects to the medical pulse generator and an output which connects to the cardiac electrode pads. A particular type of a medical pulse generator can be connected to a particular type of cardiac electrode pads given the type of input and output connectors of the adapter. Each input has a positive and a negative terminal and each output has a positive and a negative terminal. The input positive terminal is routed to the output positive terminal and the input negative terminal is routed to the output negative teπminal. The positive terminals do not contact the negative terminals.

Preferably, a plurality of adapters is kept as a set, wherein each adapter in the set has an input and output combination unique from all the rest.

In a second embodiment the adapter has a multitude of inputs and a multitude of outputs. Each input is specifically designed to connect to a particular type of a medical pulse generator and each output is specifically designed to connect to a particular type of cardiac electrode pads. All of the inputs and outputs have a positive and a negative terminal. Each of the positive input terminals is routed to each of the positive output terminals and each of the negative input terminals is routed to each of the negative output terminals. The positive input and output terminals do not contact the negative input and output terminals. Two common electric "Bus-Bars" can traverse the center of this embodiment and the negative plus the positive bus supplies electricity to all connectors appropriately.

The medical pulse generator output is connected to the appropriate adapter input and the cardiac electrode pads' input is connected to the appropriate adapter output to enable a connection between the generator and pads. Either the appropriate single input single output adapter is chosen for this purpose, or the appropriate adapter input and adapter output is chosen from the multiple input and output embodiment.

A primary object of the present invention is to provide an adapter to enable the connection between various makes and models of medical pulse generators and various makes and models of electrode pads.

A primary advantage of the present invention is that it saves time in treating critically ill heart patients.

Another advantage of the present invention is that it enables use of the readily available medical pulse generator with readily available electrode pads, which have already been applied to the patient.

Yet another advantage of the present invention is the ability of a medical facility to retain its own equipment when transferring a patient to another medical facility.

Other objects, advantages and novel features, and further scope of applicability of the present invention will be set forth in part in the detailed description to follow, taken in conjunction with the accompanying drawings, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated into and form a part of the specification, illustrate several embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating a preferred embodiment of the invention and are not to be construed as limiting the invention. In the drawings:

Fig. 1 is the medical pulse generator, adapter, and cardiac electrode pads;

Fig. 2 is the medical pulse generator output, adapter, and cardiac electrode pads input of fig. 1 ;

Fig. 3 shows an end view of the adapter input of fig. 1 ;

Fig. 4 shows an end view of the adapter output of fig. 1 ;

Fig. 5 is the input side of the multiple input embodiment of the adapter;

Fig. 6 is the output side of the multiple output embodiment of the adapter; and

Fig. 7 shows the input and output routing wires of figs. 5 and 6.

DESCRIPTION OF THE PREFERRED EMBODIMENTS (BEST MODES FOR CARRYING OUT THE INVENTION)

Fig. 1 shows medical pulse generator 6, adapter 10, cardiac electrode pads input 4, and cardiac electrode pads 2 and 2'. In this embodiment adapter positive input terminal 16 can be connected to generator positive output terminal 28, and adapter negative input terminal 22 can be connected to generator negative output terminal 32 concurrently. Cardiac electrode pads positive input terminal 26 can be connected to adapter positive output terminal 12 and cardiac electrode pads negative input terminal 30 can be connected to adapter negative output terminal 18 concurrently.

Fig. 2 again shows medical pulse generator positive output terminal 28, generator negative output terminal 32, adapter 10, and cardiac electrode pads input 4. Positive routing wire 14 ensures connection between adapter positive input terminal 16 and adapter positive output terminal 12. Negative routing wire 20 ensures connection between adapter negative input terminal 22 and adapter negative output terminal 18. Adapter 10 is configured so that these routing wires do not make contact with each other and that the positive and negative terminals of both the input and output also do not contact each other and no shorting occurs.

Fig. 3 shows an end view of one embodiment of adapter 10 of fig. 1. In this embodiment input connector 34 forms the casing for adapter positive input terminal 16 and adapter negative input terminal 22. This particular connector fits a particular type of medical pulse generator output. This is just one embodiment for connector 34. Many alternative embodiments for connector 34 are possible.

Fig. 4 shows the opposite end view of Fig. 3. This figure shows output connector 24 encasing adapter positive output terminal 12 and adapter negative output terminal 18. This particular connector fits a particular type of cardiac electrode pads. This is just one embodiment for connector 24. Many alternative embodiments for connector 24 are possible.

Preferably many different adapters with different input and output combinations are kept together as a set to enable a variety of selection and quick access to the user for whatever medical pulse generator and electrode pads are available at a given time. Also, preferably the input and output ends of the various embodiments of adapters are labeled for quick recognition by the user and quick connection between the available medical pulse generator and cardiac electrode pads. Figs. 5 and 6 show the multiple input and output embodiment 100 of the adapter. Fig. 5 shows adapter inputs 102 and fig. 6 shows adapter outputs 104. Each of these inputs connects to a particular type of medical pulse generator and each of these outputs connects to a particular type of cardiac electrode pads. Each input and output has a positive and negative terminal just as described above in the single input single output embodiment. Preferably each input and output are labeled for quick recognition by the user and quick connection between the available medical pulse generator and cardiac electrode pads.

Figs. 5 and 6 show just one embodiment. Any number of inputs and any number of outputs can be placed on this adapter in a variety of configurations. The type of connectors used for these inputs and outputs can also vary as discussed above. For example, Fig. 5 shows male connectors and Fig. 6 shows female connectors; however, any one of a number of types of connectors can be used as inputs and outputs. Furthermore, adapter inputs 102 are shown as male connectors and are extendable by approximately six inches via a cord or other connection, see Fig. 7, from adapter 100 to plug into the medical pulse generator. This too is but one way of enabling the connection to the generator, many alternative connections are possible.

Fig. 7 again shows the multiple input and output embodiment 100 of the adapter. Positive input interconnect wire 106 connects all of the positive terminals of adapter outputs 104 while positive routing wires 110, 110', 110", etc. ensure connection between the positive terminals of adapter outputs 104 and the positive terminals of adapter inputs 102. Negative interconnect wire 108 connects all of the negative terminals of adapter inputs 102 while negative routing wires 112, 112', 112", etc. ensure connection between the negative terminals of adapter inputs 102 and the negative terminals of adapter outputs 104. Adapter 100 is configured so that no positive terminal, interconnect wire, or routing wire contacts any negative terminal, interconnect wire, or routing wire and no shorting occurs. While alternative embodiments of the interconnect and routing wires is possible, the design allows the user to choose any input and any output necessary to fit the medical pulse generator and cardiac electrode pads available. It is even possible to connect one medical pulse generator to more than one set of cardiac electrode pads if this were desirable and feasible given the generator output.

Many wiring configurations are possible for both the single input single output embodiment of adapter 10 and the multiple input and output embodiment 100. Furthermore, if additional electronics are desired to, for example increase or decrease signal strength, they can be placed within the adapter. Or, a switching mechanism can be employed in the multiple input and output embodiment. Many variations of these adapters and internal configurations of these adapters are possible to accommodate the adaptation necessary between medical devices.

By using either the appropriate single input single output embodiment of adapter 10 or the appropriate input and output from the multiple input and output embodiment 100, the user can readily connect the output of the available medical pulse generator to the input of the adapter and the output of the adapter to the input of the available cardiac electrode pads. For example, a Medtronics defibrillator could be connected to ZOLL brand electrode pads. This adaptability greatly enhances the flexibility and prompt treatment of critically ill patients.

The adapters can be manufactured by many standard methods including by molding two longitudinal half-shells that feature a wire routing channel from one end of the connector. Other methods of manufacture could be casting the electrical wires in place in a totally encased one step process or a continuous injection molding and wire insertion process can be used. Regardless of the manufacturing process there is no electrical connection between positive and negative poles of the connector due to the wiring and terminal encasement, which keep the two poles or buses separate to prevent any short- circuit. The connection to the pulse generator and electrode pads is easily accomplished because the shapes of the adapter terminals only fit the electrode pads connectors and pulse generators in one way. The user can not make the connection if, for example, she tries to input the connector upside down. The adapter can be installed or removed in a matter of seconds and makes no permanent alteration to the equipment. If the electrode pads that were specifically manufactured to accompany the medical pulse generator being used are available then the adapter can be removed. However, if only certain electrode pads are available to the medical personnel then the adapter is used for rapid installation and rapid treatment of an emergency patient.

These adapters connect to different types of medical electrical pulse generating equipment which has been designed to perform defibrillation, non-invasive pacing or other electrical treatment or monitoring of the human or animal heart. The adapter can be used in hospital emergency rooms, ambulances or anywhere electrical cardiac treatment equipment exists. It can be carried in cardiac care ambulances or made available in emergency rooms where they can be utilized in situations where the necessary pads are out of supply. Then the medical personnel can use available electrode pads most promptly and thus impose the best medical treatment given the critical nature of heart attack treatment.

Although the invention has been described in detail with particular reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents.

Claims

CLAIMSWhat is claimed is:

1. A device for adapting a medical pulse generator to cardiac electrode pads, said device comprising: a device input for connection to an output of the medical pulse generator; and a device output for connection to an input of the cardiac electrode pads; and optionally wherein said device input comprises a connector capable of connecting to one of a plurality of medical pulse generators; and optionally wherein said device output comprises a connector capable of connecting to one of a plurality of cardiac electrode pads.

2. The device of claim 1 wherein said device input and said device output comprises: a positive input terminal; a negative input terminal; a positive output terminal; and a negative output terminal.

3. The device of claim 2 wherein said positive input terminal is routed to said positive output terminal and said negative input terminal is routed to said negative output terminal.

4. The device of claim 2 wherein said positive input and output terminals do not contact said negative input and output terminals.

5. A set of devices for adapting medical pulse generators to cardiac electrode pads, said set comprising a plurality of adapters wherein each of said adapters comprises:

an input for connection to an output of the medical pulse generator; an output for connection to an input of the cardiac electrode pads; and wherein each of said adapters' input and output combination is uniquely configured from all other said adapters.

6. A device for adapting medical pulse generators to cardiac electrode pads, said device comprising: a plurality of inputs for connection to outputs of medical pulse generators; and a plurality of outputs for connection to inputs of cardiac electrode pads; and optionally wherein said inputs comprise a plurality of different connectors each capable of connecting to one of a plurality of different medical pulse generators; and optionally wherein said outputs comprise a plurality of different connectors each capable of connecting to one of a plurality of different cardiac electrode pads.

7. The device of claim 6 wherein each of said inputs and said outputs comprise: a positive input terminal; a negative input terminal; a positive output terminal; and a negative output terminal.

8. The device of claim 7 wherein each of said positive input terminals is routed to each of said positive output terminals and each of said negative input terminals is routed to each of said negative output terminals.

9. The device of claim 7 wherein said positive input and output terminals do not contact said negative input and output terminals.

10. A method of connecting a medical pulse generator to one or more of a plurality of cardiac electrode pads comprising the steps of: connecting an output of the medical pulse generator to an input of an adapter; and connecting an output of the adapter to an input of the cardiac electrode pads.