Integrated external chest compression and defibrillation devices and methods of operation

Integrated devices for performing external chest compression (ECC) and defibrillation on a person and methods using the devices. Integrated devices can include a backboard, at least one chest compression member operably coupled to the backboard, and a defibrillator module operably coupled to the backboard. The integrated devices can include physiological sensors, electrodes, wheels, controllers, human interface devices, cooling modules, ventilators, cameras, and voice output devices. Methods can include defibrillating, pacing, ventilating, cooling, and performing ECC in an integrated, coordinated, and/or synchronous manner using the full capabilities of the device. Some devices include controllers executing methods for automatically performing the coordinated activities utilizing the device capabilities.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention is related to the field of resuscitation devices.

Description of the Related Art

All over the world, people experience cardiac and respiratory events. For example, both in and out of the hospital, there is a significant incidence of cardiac and/or respiratory arrest. For these situations, a variety of therapies may be appropriate. The patient may require artificial respiration, chest compressions, defibrillation, and/or pacing.

Many patents exist discussing devices related to these events and situations. For example, a chest compression device is taught in U.S. Pat. No. 6,234,984 B1. Some of these devices even aggregate such features, such as are described in U.S. Pat. Nos. 4,349,015, and 4,424,806.

Many of the prior art devices, however, merely aggregate such features, without making them work together. Therefore there exists a need for devices that can combine, coordinate and integrate various aspects of these diagnostics and therapies to better diagnose and treat the patient. That is because many of these conditions are related, and a patient might need one of these therapies alternating with another.

SUMMARY OF THE INVENTION

The present invention overcomes these problems and limitations of the prior art. Generally, the present invention provides devices, software, and methods as described below. Some embodiments of the invention provide a single device that can monitor a patient and administer diverse therapies as they arise.

In general, the preferred device of the invention includes functionalities that may perform chest compressions automatically, as well as defibrillate, monitor, pace, and ventilate. Preferably, all of these functions are automated. For those that are not automated, preferably there are instructions issued to the user.

One benefit of the invention is that monitoring and treatment are made more comprehensive, and synergies are accomplished between the disparate monitoring and treatment modes. Moreover, the invention can permit the user to carry a single item to the rescue scene.

The present invention provides an integrated device for performing external chest compression (ECC) and defibrillation on a person. The integrated device can include a backboard, at least one chest compression member operably coupled to the backboard, and a defibrillator module operably coupled to the backboard. Some devices include at least one sensor for outputting data and sensing physiological data from the patient. The backboard can be formed of an electrically non-conductive material and can have an electrode disposed in the backboard. In some devices, the physiological data includes at least one attribute from the group consisting of pulse, heart beat, breathing, body temperature, externally applied chest pressure, and thoracic impedance. Some devices include wheels and a handle for transporting the device and/or transporting a patient on the device. A controller or processor may be coupled to the device and may be further coupled to a human interface module or I/O module. The controller can be coupled to the sensor and can execute logic to defibrillate the person responsive to sensor data indicative of cardiac arrest. In some embodiments, the controller can execute logic to pace the person responsive to sensor data indicative of bradycardia.

Some devices include a cooling module for cooling the person. The cooling module can include a cooling garment that can be placed over the person. In some devices, a controller can execute logic to initiate cooling responsive to sensor data indicative of cardiac arrest in the person.

Devices can include an electrode attached to the chest compression member of the device. Some electrodes include a releasable electrolyte that can be released upon application of pressure or an external signal. Chest compression members can include a belt and/or a vest, which can be coupled to a powered actuator for retracting the belt or vest. Some chest compression members include a rigid member pivotally coupled to the backboard. The rigid member can be coupled to a powered actuator for effecting ECC, or may be manually operable, depending on the embodiment. Some chest compression members include a pressure sensor for measuring external pressure applied to the chest. Other devices include a second defibrillation electrode, where the second defibrillation electrode can be disposed on the belt, vest, or other chest compression member. Some devices include multiple defibrillation electrodes coupled to the chest compression member. Multiple ECG electrodes may also be disposed on the belt, vest, or other chest compression member.

A voice output device may be included in some integrated devices. A camera coupled to a transmitter may be included in other devices. A ventilator for ventilating the patient can be included in still other integrated devices according to the present invention.

One method according to the present invention includes placing a person on a backboard of an integrated device, causing a chest compression member of the device to compress the person's chest against the backboard, causing the device to sense physiological signals of the person by a sensor, and causing a defibrillation module of the device to defibrillate the person depending on the sensed signals or responsive to the signals. Some methods further include listening to a voice output of the device. The signals can be sensed by bringing the sensor in contact with the person in some methods. The sensors may be brought in contact with the person by bringing the chest compression member in contact with the chest. Placing the person on the backboard can result in the person contacting a defibrillator electrode of the device.

Some methods include cooling the person using a cooling module of the device, which can include a cooling garment, or the cooling can be performed responsive to physiological signals of the person. The cooling may be performed automatically by the integrator device responsive to the physiological signals. Some methods include ventilating the person using a ventilator of the device, or the ventilating can be performed responsive to the physiological signals. In still other methods, the person is paced using a pacing module of the device, to pace the person responsive to the signals.

The present invention also includes methods that can be implemented using a controller or processor of the integrated device. The methods can be implemented using hardware, software, firmware, or other modality. The methods implemented in any of these modalities can reside in a computer-readable media.

One method that can be implemented in a controller includes receiving an input that a person has been placed on a device backboard and generating instructions to operate a chest compression member of the device to compress the person against the backboard. The method can further include receiving a physiological signal of the person and operating a defibrillation module of the device to defibrillate the person in response to the signal. The chest compression member can also be controlled in response to the signal. Some methods can generate voice outputs that can issue chest compression instructions, drug delivery instructions, manual ventilation instructions, cooling instructions, pre-cordial thump delivery instructions, and/or instructions to manually ventilate the person in synchrony with the chest compression instructions.

Some methods generate instructions to initiate defibrillation responsive to physiological signals indicative of ventricular fibrillation, ventricular tachycardia, and/or other physiological signals indicative of cardiac arrest. Methods can include generating instructions to ventilate the person in response to physiological signals indicative of lack of breathing. Some methods generate instructions to operate a pacing module responsive to physiological signals indicative of ventricular bradycardia. Instructions may also be generated to monitor thoracic impedance over time. Methods may include monitoring chest compressions and generating instructions to operate a pacing module in synchrony with the monitored chest compressions.

DETAILED DESCRIPTION

FIG. 1illustrates an integrated external chest compression (ECC) and defibrillation device30. Integrated device30includes a backboard or back frame32, chest compression members40, a ventilator42, a human interface device54, and a defibrillating and/or pacing module46.

Backboard32is shown as solid and having an upper surface34. Backboard32need not be solid. Backboard32is preferably made as lightweight as possible, allowing the integrated modules to be included without adding unneeded weight. In some embodiments, wheels36and a handle38are coupled to backboard32. This permits the device to be used as a gurney, making it easier to transport the patient.

The chest compression portion may be implemented in a number of ways, as described below. Two chest compression members40are shown, in the form of two arms. Chest compression members40are coupled to backboard32. Even though only two arms are shown, the chest compression members may be implemented as a belt, and/or as a vest, either a full or partial vest. The belt or vest is intended to generally wrap around the chest of the patient, for squeezing it, or squeezing it against backboard32. In this way, ECC or CPR can be administered to the patient. The belt or vest may incorporate other functionalities, as further described below. In addition, it may be removable and/or reusable.

Integrated device30includes a defibrillating and/or pacing module46, hereinafter referred to generally as a defibrillating module or defibrillator. Defibrillator46can be electrically coupled to a posterior electrode48embedded in backboard32. Backboard32may be formed of an electrically insulating material to electrically isolate posterior electrode48. Electrode48can be disposed to contact the patient's back, on the left side. Defibrillator46can also be coupled to a defibrillator or pacing electrode50, disposed on chest compression member40. In some embodiments, at least one defibrillator electrode is disposed on the under-side of the belt, chest compression member, or vest to contact the patient's chest near the heart.

Integrated device30further includes a ventilator or ventilating module42. Ventilator42can include ventilator tubing44. Ventilator42can also be coupled to backboard32and can be used for ventilating the patient. Ventilator42is shown schematically, as ventilators are well known to those skilled in the art.

Human interface device54can be implemented in a number of ways. Human interface device54can include an input portion56and an output portion58. Input portion56can include a keyboard and output portion58can include a visual display or computer screen and/or a voice output module for interacting with a human assistant. A battery52can be carried within backboard32for supplying power for operating human interface device54, defibrillator46, ventilator42, and chest compression members40, in the various embodiments of the invention. A controller or computer can also be included within human interface device54or elsewhere within integrated device30for integrating and coordinating the operation of external chest compression, defibrillating, pacing, and ventilating, depending on the embodiment of the invention present.

FIG. 2illustrates integrated device30having a person or patient100disposed on backboard32. Patient100has a chest102disposed under chest compression members40and a mouth104for receiving ventilator tubing44.

FIG. 3illustrates another integrated device120for integrating external chest compression and defibrillation and/or pacing. Integrated device120may be seen to include chest compression members40, human interface device54, battery52, and defibrillator module46, as previously described with respect toFIG. 1. Integrated device120includes a short backboard or back frame126. Shorter backboard126can decrease the weight and increase the portability of the integrated device.

FIG. 4illustrates an integrated device150, in which the chest compression is effected by a compressor or expandable member held in place by a belt or vest153, depending on what is provided in the particular embodiment. The chest compressor includes a mechanism for pushing downwards on the chest. In the integrated device illustrated, the compressor is implemented as a base151and a piston152. Piston152is illustrated in a first, retracted position154and a second, extended position156. Belt or vest153can be coupled to a back frame158, as previously discussed.

FIG. 5illustrates an integrated device170. The integrated device170includes a belt or vest172, having a buckle, hook and loop fastener (e.g. Velcro™) or zipper174for fastening around the chest of the patient. Belt or vest172can itself be contracted to effect chest compression. The contraction can take place in many ways. In one way, the belt or vest can be retracted into a back frame176. In another way, belt or vest172can be constricted about the patient. Belt or vest172may be seen having a first, expanded position173and a second, constricted position178. In yet another way, chest compression is effected by electrically stimulating the chest muscles.

FIG. 6illustrates still another integrated device200having a patient206disposed on a backboard210. In device200, chest compression is provided by rigid chest compression members or arms202having support prongs208that push down on the chest of patient206. Arms202can be pivotally coupled to backboard210. In the embodiment illustrated, arms202are operated by gears204that are integrated with backboard210. In some embodiments, arms202are driven by a powered chest compression actuator.

FIG. 7illustrates another integrated device220including backboard210carrying patient206, as previously described. Integrated device220includes a force multiplier224using a lever arrangement, so that a pressing member can exert a downward pressure on the patient chest. Integrated device220includes a gear box or a powered actuator230coupled through a shaft or rod228, which may be hollow in some embodiments. Shaft228can have first force transmission member236slidably received within shaft228and pivotally coupled to a second force transmission member232and a third force transmission member234. Force transmission members232and234can be further coupled to a chest compression pad235for pressing against the chest of patient206. Force multiplier device224can be held in place by a belt or vest222. In some embodiments, the lever arrangement may operate by having a rod conduct a long rotation, such as in a corkscrew arrangement.

Other embodiments of the chest compression portion include belts crossing the chest from over the shoulder down to the chest, forming an “X” across the patient's chest. This is better than the conventional way of having belts horizontally across the patient's chest, in that it permits placement of sensors such as leads in different places. Alternately, an “X”-belt configuration may be combined with the conventional configuration. In yet other embodiments, the chest compression portion includes devices performing active compression-decompression, devices that combine chest compressions with abdominal compressions, devices where the belt is operated electronically without gears, and devices that use electricity to do chest compressions by electrically inducing chest muscles to contract. Various embodiments may use combinations of these chest compression techniques.

Compressing and releasing may be performed according to any type of time profile. One such profile is seen inFIG. 19. Other profiles may be sine-wave, triangular shaped, or other shapes. In an advantageous embodiment of the invention, a sine-wave may be used with a frequency outside the ECG range. This permits analyzing the ECG while simultaneously performing chest compressions. This permits the device to detect more quickly a rhythm that requires a defibrillation shock, and to reduce the delay of its delivery from the end of the chest compressions.

Referring again toFIGS. 1, 2, and 3, the invention defibrillation-pacing portion can be either formed integrally with the backboard or is removable from it. In any event, the defibrillation-pacing portion can operate when integrally connected with the back frame or backboard.

The defibrillation-pacing portion is capable of performing defibrillation, and optionally, also pacing. Pacing may be implemented by a separate module than defibrillating, but it is highly advantageous to have the same module perform both functions. The defibrillation/pacing portion may operate as a defibrillator of any chosen automation level. That includes operation that is fully automated to fully manual, and every option in between.

Moreover, the invention may also advantageously provide devices or modules that perform monitoring, and further provide interpretation of the monitored signals. The monitoring results may advantageously be displayed on the human interface device previously described or on an I/O module as described below. In other embodiments, there is a separate monitoring module. Monitoring may be of any of the monitoring parameters or physiological attributes common on defibrillator/monitors or bedside monitors today, for example, NIBP, SpO2, CO2, 12 lead ECG, etc. The devices that perform the monitoring are preferably integrated with the back frame, and preferably are removable for servicing.

The invention also can include an input/output (I/O) or human interface module as previously described. In the embodiment ofFIG. 1, human interface device54includes a display screen and keyboard, as previously discussed, but that is not limiting. The invention can also have input devices such as keys, switches, knobs, levers, a microphone for voice recording, and preferably also voice recognition, and output devices such as one or more screens, a speaker, printer, or other output device. All of these are preferably aggregated at the I/O module, but that is not necessary for practicing the invention. They may be located elsewhere in the devices, or received remotely, for example, wirelessly, or transmitted wirelessly to a remote output device.

The invention also optionally includes a ventilation portion. A ventilation portion or ventilating module42was previously described with respect toFIG. 1. The ventilation portion may be implemented either automatically, or be intended for use by a human operator. If by a human, the device may be made giving prompts for instructing the rescuer. The prompts may be timed. The rescuer may be either performing mouth-to-mouth resuscitation or opening a bag valve mask device where the user manually squeezes the bag. If the ventilator is to be automatic, a tube can be inserted into the patient's mouth, and a pump can be used. Alternatively, a mask may be placed on the face of the patient. The oxygen can be delivered this way to the patient. Other devices, such as valves that block the airway during chest decompression, for example, the CPR-x valve, can be included in the ventilation portion of the device of the invention. To the extent it is automatic, a pump of the ventilation portion may be advantageously integrated with the back frame.

The invention preferably also includes an electrical power source for powering the various portions. The power source may be a battery, such as battery52discussed with respect toFIG. 1. The battery may be either a rechargeable battery for maximum portability, or a replaceable battery. The battery is preferably integrated with the back frame, either permanently, or in such a way that it can be removed and replaced. Some devices of the invention have the benefits of being able to share a common power source, CPU or controller, and I/O module for the interface with the rescuer.

FIGS. 8 and 9illustrate how defibrillator electrodes or other electrodes might be attached to an underside of the vest or belt of the chest compression portion of the devices ofFIG. 1, 2, or3. For example, the electrodes can be part of a belt or vest ofFIG. 4 or 5. The electrodes can also be integrated with an arm or a prong of a chest compression member, for example, prong208ofFIG. 6or chest contact pad235orFIG. 7.

FIG. 8illustrates a belt or vest having a first portion300coupled through a buckle or zipper304to a second portion302. A first electrode306may be affixed to the underside of the belt or vest and coupled to a wire or lead308. InFIG. 8, one of the electrodes is situated on the underside of the belt or vest, while the other electrode may be expected to be in the backboard. At least one wire can connect the electrode to the remainder of the defibrillation/pacing portion. This is a preferred embodiment, since it would minimize CPR artifact in the ECG signal. The electrode preferably avoids the center of the chest. That is where the buckle or zipper is shown (as wider than the open portion that supports the electrode).

FIG. 9illustrates the belt or vest ofFIG. 8, having belt or vest first portion300, buckle or zipper304, and second portion302. First electrode306and wire308are as previously described with respect toFIG. 8. InFIG. 9, a second electrode310is coupled to a second wire or lead312. In the embodiment illustrated inFIG. 9, no electrode is needed in the backboard or back frame for traditional defibrillation. At least one wire can connect each electrode to the defibrillation/pacing portion.

FIG. 10illustrates the underside of another belt or vest having a first portion320coupled through a buckle or zipper324to a second portion322. Belt or vest first portion320may be seen carrying a first electrode326and a second electrode327, coupled to wires332. Belt or vest second portion322may be seen carrying third electrode328, fourth electrode329, and fifth electrode330, all coupled to wires332. Wires332, while having similar reference numbers, are, of course, preferably electrically distinct. The ECG leads ofFIG. 10are also preferably integrated with the underside of the vest or belt of the chest compression portion of the devices ofFIG. 1, 2, or3. The ECG leads may be placed so as to not interfere with any defibrillation electrodes, for example, those ofFIGS. 8 and 9.

FIG. 11illustrates yet another belt or vest having a first portion340coupled through a buckle or zipper344to a second portion342. The underside of belt or vest first portion340may be seen carrying a first sensor346coupled to a wire or other signal transmission medium349. The underside of belt or vest second portion342may be seen carrying a second sensor347, and a third sensor348, coupled to wires349. The sensors are preferably also integrated with the underside of the vest or belt of the chest compression portion of the devices ofFIGS. 1, 2 and 3. These sensors can include pulse detection sensors, such as those made from piezoelectric materials, temperature sensors, CO2sensors, and other sensors for measuring physiological attributes or signals, well known to those skilled in the art.

The features integrated with the belt or vest are preferably arranged so that they do not interfere with each other. The electrode may be fully integrated, or detachable for servicing. Alternately and equivalently, some electrodes, ECG leads, or sensors may be hosted in the backboard.

FIGS. 12 and 13illustrate how defibrillator electrodes, ECG leads, or sensors may be integrated with an underside of the vest, belt, or other chest compression members, for example those inFIG. 1, 2 or 3.

FIG. 12illustrates a belt or vest350carrying an electrode, lead, or sensor352. Electrode, lead, or sensor352can be coupled to a wire356and biased downward from the belt or vest with a spring354, so as to be pressed against the chest of the patient. For use with a pulse sensor, some quieting time for the spring is preferably allowed, so as to not provide interference with the signal.

FIG. 13illustrates a belt or vest360carrying an electrode, lead, or sensor362on the underside of the vest or belt. A gel or electrolyte364may be seen on the underside of the electrode, lead, or sensor362. For implementing an electrode, a gel may be administered, or an electrolyte may be diffused. The gel or electrolyte may be provided in a capsule that bursts at an appropriate time to release it. The time may be prior to defibrillation electrotherapy. Bursting may be caused by the mere pressure against the chest, or by an appropriate electrical signal. One advantage that can be provided by some embodiments is that there is no need to disrobe the patient—the fluid may seep through the clothes to establish electrical conduction.

FIG. 14illustrates some other optional features of the invention. Integrated device30, patient100, and backboard32are shown, as previously described. A camera382may be seen disposed on a post secured to backboard32. Camera382can be coupled to a communication module380that can act as a transmitter or transceiver. Communication module380can communicate with a remote assistance center396coupled through a network394and a remote antenna392. A data/voice/video communications link390is shown as existing between communication module380and remote assistance center antenna392. Communication link390can be bi-directional in some embodiments. In a preferred embodiment, communications module380includes the functionality of a portable telephone, and network394is a network that can support voice and/or data communications. Camera382is preferably a digital camera, and may be either a video camera or a still camera. The camera may be advantageously attached to a post in the backboard. This permits recording of the scene and the patient. The recording may be used for record keeping, event analysis, and other purposes. Alternately, the recording may be used for live transmission to the remote assistance center396, where more trained medical personnel can in turn provide feedback.

The user of the invention can establish communication link390with remote assistance center396. Then the information can be transmitted and can include images, if a camera is provided. The patient's vital signs, encoded by the invention for communication, along with the rescuer's comments, observations, and even questions may be also transmitted to the remote assistance center.

In some embodiments, the invention is operable from remote assistance center396. An operator at the remove assistance center can transmit a command code through communication link392integrated device30, and integrated device30operated accordingly. Such operation may actually include defibrillation.

Moreover, the monitored data, included also recorded data such as events, wave forms, physiological signals or attributes, and data indicative of the device operation itself, may be also transmitted to a system for collecting or storing patient information, and to a computer-aided dispatch system for assistance. Furthermore, it may also be sent to a billing system for determining patient billing.

FIGS. 15 and 16illustrate additional optional cooling figures of the invention. Cooling can be provided for performing IMHT (Induction of Mild Hypo Thermia), which may slow down adverse effects of the events being experienced by the patient.

Integrated device30and patient100are as previously described.FIG. 15illustrates generally a cooling module aspect of the present invention. In the example illustrated, the cooling module includes a liquid gas storage container or tank402coupled to a valve404coupled in turn to a tube406coupled to a cooling garment408. Liquid gas storage container402can be included within the cooling module and is preferably carried under the backboard. This is most advantageous in the event the backboard is implemented with wheels.

The liquid in container402can be one that preferably turns into gas upon being released into the atmosphere. A cooling garment, similar to cooling garment408, can be provided for each part of the body that is of interest to cool. The cooling garment can be shaped to be suitable for placing over the bodily part that is to be cooled. Cooling garment408illustrated inFIG. 15is designed for placement on the patient's head. Cooling may also be accomplished by evaporative cooling, for example, using a suitable fluid delivery system and an absorber for alcohol, such as cotton.

FIG. 16illustrates a section of cooling garment408. Garment408has an inner shell409for contacting patient100. Garment408also has an outer garment or shell411that defines an inner space405between outer shell411and inner shell409. Spacers may be used to maintain inner space405in an open configuration. Alternately, small tubes may be used. Garment408can receive liquid gas from storage container402via tube406in communication with inner space405. The cooling gas or liquid can also be received into the series of small tubes, previously described. The gas can then be released into the atmosphere from various places in the garment. As it is being released, the gas can expand, cool, and thus draw heat away from the patient. Sensors, for example for temperature, may also be included.

Referring again toFIG. 15, the gas can be directed from storage container402to liquid controller or valve404, and from there to garment408via tube406. Liquid controller404can in turn be controlled by an IMHT controller, for controlling the rate of cooling of the patient. The expanded cooled gas may be mixed with air to control the final cooling gas/air temperature. The IMHT controller may be implemented in combination with the liquid controller, and optionally further communicates with the processor or controller of the device of the invention.

The present invention may be implemented by one or more devices that include logic circuitry. The device performs functions and/or methods as are described in this document. The logic circuitry may include a processor that may be programmable for a general purpose, or dedicated, such as microcontroller, a microprocessor, a Digital Signal Processor (DSP), etc. For example, the device may be a digital computer like device, such as a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer. Alternately, the device may be implemented as an Application Specific Integrated Circuit (ASIC), etc. These features can be integrated with the invention, or coupled with it.

Moreover, the invention additionally provides methods, which are described below. The methods and algorithms presented herein are not necessarily inherently associated with any particular computer or other apparatus. Rather, various general-purpose machines may be used with programs in accordance with the teachings herein, or it may prove more convenient to construct more specialized apparatus to perform the required method steps. The required structure for a variety of these machines will become apparent from this description.

In all cases there should be borne in mind the distinction between the method of the invention itself and the method of operating a computing machine. The present invention relates both to methods in general, and also to steps for operating a computer and for processing electrical or other physical signals to generate other desired physical signals.

The invention additionally provides programs, and methods of operation of the programs. A program is generally defined as a group of steps leading to a desired result, due to their nature and their sequence. A program made according to an embodiment of the invention is most advantageously implemented as a program for a computing machine, such as a general-purpose computer, a special purpose computer, a microprocessor, etc.

The invention also provides storage media that, individually or in combination with others, have stored thereon instructions of a program made according to the invention. A storage medium according to the invention is a computer-readable medium, such as a memory, and is read by the computing machine mentioned above.

The steps or instructions of a program made according to an embodiment of the invention requires physical manipulations of physical quantities. Usually, though not necessarily, these quantities may be transferred, combined, compared, and otherwise manipulated or processed according to the instructions, and they may also be stored in a computer-readable medium. These quantities include, for example electrical, magnetic, and electromagnetic signals, and also states of matter that can be queried by such signals. It is convenient at times, principally for reasons of common usage, to refer to these quantities as bits, data bits, samples, values, symbols, characters, images, terms, numbers, or the like. It should be borne in mind, however, that all of these and similar terms are associated with the appropriate physical quantities, and that these terms are merely convenient labels applied to these physical quantities, individually or in groups.

FIG. 17illustrates a general computer, processor, or controller440having a data storage device or computer readable medium446interfaced with computer440to transfer data via link448, or the data may define a program. Computer440ofFIG. 17may be implemented by a CPU, and preferably interfaces with the IO module or human interface device previously described. Computer or controller440includes a memory442containing executable logic or program444.

This detailed description portion is presented largely in terms of flowcharts, display images, algorithms, and symbolic representations of operations of data bits within at least one computer readable medium, such as a memory. An economy is achieved in the present document in that a single set of flowcharts is used to describe both methods of the invention, and programs according to the invention. Indeed, such descriptions and representations are the type of convenient labels used by those skilled in programming and/or the data processing arts to effectively convey the substance of their work to others skilled in the art. A person skilled in the art of programming may use these descriptions to readily generate specific instructions for implementing a program according to the present invention.

Often, for the sake of convenience only, it is preferred to implement and describe a program as various interconnected distinct software modules or features, individually and collectively also known as software and softwares. This is not necessary, however, and there may be cases where modules are equivalently aggregated into a single program with unclear boundaries. In any event, the software modules or features of the present invention may be implemented by themselves, or in combination with others. Even though it is said that the program may be stored in a computer-readable medium, it should be clear to a person skilled in the art that it need not be a single memory, or even a single machine. Various portions, modules or features of it may reside in separate memories, or even separate machines. The separate machines may be connected directly, or through a network, such as a local access network (LAN), or a global network, such as the Internet.

It will be appreciated that some of these methods may include software steps which may be performed by different modules of an overall parts of a software architecture. For example, data forwarding in a router may be performed in a data plane, which consults a local routing table. Collection of performance data may also be performed in a data plane. The performance data may be processed in a control plane, which accordingly may update the local routing table, in addition to neighboring ones. A person skilled in the art will discern which step is best performed in which plane.

In the present case, methods of the invention are implemented by machine operations. In other words, embodiments of programs of the invention are made such that they perform methods of the invention that are described in this document. These may be optionally performed in conjunction with one or more human operators performing some, but not all of them. As per the above, the users need not be collocated with each other, but each only with a machine that houses a portion of the program. Alternately, some of these machines may operate automatically, without users and/or independently from each other.

Methods of the invention are now described.

Referring now toFIG. 18, a flowchart2000is used to illustrate a method according to an embodiment of the invention. The method of flowchart2000may also be practiced by the devices of the invention described in this document. Above and beyond the method described herein, the responder (who is also a user) may be instructed on how to apply a device, and or interactively give feedback, and/or to perform steps of the method, etc.

According to a box2010, signals are received about the patient, and optionally are also monitored. Optionally, they are also recorded, displayed, transmitted, etc.

The signals are received from the patient (such as ECG), from special sensors (such as oximetry, impedance, force, pulse detection sensors, etc.). Signals may also be received from other components or devices (size of belt or vest around patient's chest, GPS signals, control signals from a device of a responder attending to the patient, etc.). Signals may further be received from the responder interactively, e.g. by asking questions and receiving answers.

The signals are then analyzed and treated as inputs, as is also shown in the rest of flowchart2000. Analysis may be implemented also by taking advantage of the combined functionalities and features. For example, knowledge of the time profile of the chest compression is used to remove the chest compression artifact from the ECG.

The process of box2010preferably takes place continuously, even if execution moves also to other boxes of flowchart2000. Monitoring is for the conditions that are applicable for the below, including, for example, for the effectiveness of chest compressions. There can be different stages of monitoring, such as main monitoring, at exact box2010, and secondary monitoring concurrent with other stages, e.g. at the same time as any one of boxes2030,2040,2080below.

In addition, monitoring may be also for detecting Acute Myocardial Infarction (AMI), via the ECG or other monitoring parameters, and indicating this to the caregiver. If AMI is detected, then monitoring may also be for cardiac arrest (which commonly occurs following an AMI).

In addition to monitoring, preferably there is also recording. The accumulated record may include records of events, data monitored, and functionalities of the invention that are operating, and time profiles of their operation.

A number of decision trees may then be implemented, in determining what action to take next. The best embodiments known to the inventors are described, but that is only by way of example, and not of limitation. Further, the flowchart may be integrated with other steps, such as administering medications (e.g. cardiac drugs), etc. But simplistically, the ECG input is analyzed for a shockable rhythm, and then either defibrillation takes place, or pulse or other signs of circulation are checked, following the same protocol as today's AEDs. Further, a user would be prompted to start the CHEST COMPRESSION PORTION device and ventilations if there was no pulse (or no signs of circulation). A more rigorous way is described below.

According to a next box2020, it is determined whether Ventricular Fibrillation (VF) of the patient's heart is occurring. If so, then according to a next box2030, the patient is defibrillated. This is accomplished by administering electrotherapy, such as a defibrillation shock. If a child (“pediatric”) patient is sensed, then the defibrillation energy level may be adapted automatically (e.g. be set to 50 J). Such sensing may be from responder inputs, the belt or vest size when tightened around the patient, etc.

In some embodiments of the invention, at box2030, instead of delivering a defibrillation shock, the CPR portion is used to deliver a precordial thump to deliver the patient. In particular, when the device detects a shockable rhythm, rather than delivering an electrical defibrillation pulse, the device first deliver a precordial thump to the patient, via the chest compression device, to attempt defibrillation. This is a great advantage of the invention, in that it can revert from one form of therapy to another.

In yet other embodiments, based on the patient's downtime (which could be entered into the device by the caregiver), or by analysis of parameter that indicates probability of shock success (such as ECG), it may first be decided whether to deliver electrotherapy, or to first perform CPR, and/or to first deliver medications prior to defibrillating. That action could either be started automatically by the system, or could be started with manual action from the user.

Execution may then return to box2010, where inputs are received and analyzed. In a preferred optional embodiment, however, according to a next box2040, Cardiopulmonary Resuscitation (CPR) is either performed automatically, or instructed for the responder to perform, after defibrillating. Instruction may be by voice commands, and/or may include sounds for the responder to synchronize their action. In addition, depending on the monitored inputs, the repetition rate of the CPR is adjusted. Further, if CPR is performed automatically, the force and its time profile are also adjusted. Execution returns to box2010.

According to important alternate embodiments of the invention, boxes2030and2040take place together. In other words, defibrillation takes place while CPR is being performed automatically.

Referring briefly toFIG. 19, a time profile of the chest compressions is shown. More particularly, the changing circumference of the patient chest is plotted, as squeezed and released. In addition, the main level of the patient impedance is plotted in dashed lines, following in pattern the time profile of the chest circumference. (Other impedance variations may be superimposed on the main level of impedance). The profile of chest squeezing may be known directly, or indirectly from a monitored parameter such as the main level of impedance.

Advantageously, defibrillation (the large lightning bolts inFIG. 19) may take place any time in the CPR cycle. The exact timing is chosen in synchronization to pursue various optimizations. For example, if it is desired to exploit the smallest possible impedance, defibrillation happens according to bolt (A). On the other hand, if it is desired to exploit the moment that the heart is filled with the most blood (and thus draw the most current through the heart), then defibrillation happens according to bolt (B).

CPR may continue after defibrillation, or even be halted after it. An advantage of the invention is that the waiting time from CPR to defibrillation is minimized. Pacing takes place as described later in this document.

Returning toFIG. 18, if, at box2020it is determined that the patient is not undergoing VF, then according to an optional next box2050, it is inquired whether a pulse is detected. If not, then according to an optional next box2060, it is inquired whether the condition of Ventricular Tachycardia (VT) is detected. If so, then execution reverts to box2030, and the patient is defibrillated. But if no VT is detected at box2060, then execution reverts to box2040for performing CPR.

If a pulse is detected at box2050, then, according to an optional next box2070, it is inquired whether respiration is detected. If so, then execution returns to box2010. Respiration may be detected automatically by respiration sensors, such as a CO2 (carbon dioxide) sensor, chest movement sensor, or an impedance sensor.

If at box2070there is no respiration detected, then according to an optional next box2080, ventilation is performed automatically by a ventilator, or rescue breathing is instructed for the responder to perform. Execution returns to box2010.

Since box2010is preferably executed continuously, the method also includes discontinuing one type of therapy, and optionally also starting another consistently with the above. Also, if one of the signs changes, execution may return to box2010and start over. For example, pulse may be lost while ventilating. Or the onset of respiration may detected, in which case other activities (such as ventilation) stop.

Referring now to optional box2090, optional pacing according to the invention is also described. In the embodiment ofFIG. 18, the condition for enabling pacing is examined in two circumstances, namely in transitioning from box2050to2070, and also in transitioning from box2060to2040.

Referring now toFIG. 20, box2090is described in more detail. In both cases, it is inquired whether severe bradycardia is detected. In addition, if no pulse has been detected, it is inquired whether ventricular asystole has been detected. If not, then execution continues as before (from box2050to2070, and from box2060to2040). If yes, then according to a box2095, pacing is performed.

Returning toFIG. 19, pacing (shown as a small lightning bolt) may also be coordinated with the administration of CPR. Pacing is preferably synchronized with the compression cycle. There is some evidence that chest compressions may cause a QRS complex (ventricular depolarization), if the heart is able to support it. Accordingly, pacing during the compression cycle provides the additional impetus to the ventricles. Also, pacing should be avoided a few 100 msec after a QRS complex, during the ventricular vulnerability period.

At any one time during the method ofFIG. 18, inputs are received (for monitoring) from the available sensors, and from the user through the I/O module. Outputs are communicated to the user through the I/O module.

Referring now toFIG. 21, a sample screen snapshot is shown. The screen is advantageously used for communicating to the user the monitored data (such as vital signs), outputs, comments, actions, etc. In the example ofFIG. 21, there is a count down for imminent defibrillation (at the 3 sec point).

A person skilled in the art will be able to practice the present invention in view of the description present in this document, which is to be taken as a whole. Numerous details have been set forth in order to provide a more thorough understanding of the invention. In other instances, well-known features have not been described in detail in order not to obscure unnecessarily the invention.

While the invention has been disclosed in its preferred form, the specific embodiments as disclosed and illustrated herein are not to be considered in a limiting sense. Indeed, it should be readily apparent to those skilled in the art in view of the present description that the invention may be modified in numerous ways. The inventors regard the subject matter of the invention to include all combinations and subcombinations of the various elements, features, functions and/or properties disclosed herein.