CH713342A2 - Automated diagnostic and therapeutic device for cardio-metabolic resuscitation, controlled by external defibrillator. - Google Patents

Abstract

The device according to the invention provides to an automated external defibrillator (AED) the ability to perform transcutaneous injections, facilitated by the iontophoresis and / or sonophoresis technologies of resuscitation drugs (eg: adrenaline), depending vital data collected on the patient by sensors integrated into the device. The device uses patches driven by the defibrillator. Thanks to this, early drug administration is possible before the arrival of specialized relief. Its use does not require skills other than training already provided to the general public (eg first aid).

Description

Description

OBJECT AND / OR TECHNICAL FIELD [0001] The invention relates to the field of health, more specifically emergency medicine since it is a device for the resuscitation of patients in vital distress.

Description of the invention

STATE OF THE ART [0002] Cardiac arrest is a common occurrence in the world, with in particular tens of thousands of patients affected each year in North America and Europe.

Survival after cardiac arrest is dependent on etiology, at best 10% in case of asystole (stopping the electrical activity of the heart) against 20% in case of ventricular fibrillation (anarchic electrical activity of the heart).

[0004] Currently, the recommendations advocate during a cardiac arrest (see Fig. 1): - to call for help from a specialized team - to perform an external cardiac massage, - to set up on the thorax of the victim the patches / electrodes of the automatic defibrillator and turn on the latter.

From this moment, the automated defibrillator will analyze the underlying heart rhythm. In case of ventricular fibrillation, and only in this case, the defibrillator will deliver a series of electric shocks to restore an orderly cardiac activity.

Disadvantage [0006] In case of asystole, or other serious cardiac arrhythmia (except ventricular fibrillation), no additional therapy is delivered until specialized help arrives, proceed to the establishment of a venous access (or other possible access) allowing the injection of adrenaline or other recommended medication (see Fig. 1). Three complementary concepts are to be distinguished: 1. Except for ventricular fibrillation, the diagnosis and treatment of which can be performed by the automatic defibrillator, the diagnosis of other cardiac disorders and the therapeutic decisions are the responsibility of the physician only, and based on the the patient's clinical condition and cardiac rhythm analysis. 2. The drug injection (s) are prescribed by the physician but can also be performed by trained paramedics. 3. the practice of basic emergency procedures (external cardiac massage ...) which can only be performed by any witness trained in these actions.

Thus, many minutes may pass before the first dose of adrenaline circulates in the victim's blood system. Recent studies have shown that when adrenaline is injected before the tenth minute, the neurological sequelae of cardiac arrest are significantly less than after the 10th minute. [1-2]

TECHNICAL PROBLEM [0008] The object of the present invention is to develop an apparatus which, in an automated manner, can make the diagnosis (s) and the administration of ad hoc drugs in case of malaise or cardiac arrest according to a new algorithm presented in fig. 2.

[0009] For twenty years, there exist devices for accelerating and forcing the transcutaneous passage of drugs. Among them, iontophoresis (electrically powered patch that forces the transcutaneous passage between the anode and the cathode: see Fig. 3a), and sonophoresis (ultrasonic device that increases the permeability of the skin to certain substances: see Fig. 3b) have been described but little used including in the field of resuscitation.

Solution [0010] The features described in claim 1 solve this problem. This is a device called "LifePatch", which provides classical DAE with the ability to perform transcutaneous injections (facilitated by iontophoresis and / or sonophoresis technologies) of resuscitation drugs, based on vital data collected from the patient by sensors integrated into the device.

Advantages [0011] The expected benefit of this device is to reduce the time before the adrenaline administration, even before the arrival of specialized assistance. It is then expected a possible improvement of the state of these patients in terms of recovery of cardiac activity, survival and reduction of neurological sequelae.

Another advantage is that vis-à-vis the potential user public automated defibrillators, the establishment of patches / electrodes on the chest of the patient remains the same. Thus, no additional training will be necessary for the public already trained in handling conventional automated defibrillators.

In addition, this device can be extended to other circumstances of discomfort requiring injection of other active substances: for example glucose in case of hypoglycemia measured by the transcutaneous device.

Enumeration of Figures / Drawings [0012]

Fig. 1: Algorithm in simplified view of the management of cardiac arrest.

Fig. 2: Algorithm that we propose for the management of resuscitation of cardiac arrest with Life-

Patch.

Fig. 3a: Schematic principle of lontophoresis Fig. 3b: Schematic Principle of Sonophoresis.

Fig. 4: Lifepatch: patches sternal (right) and apical (left) on their cutaneous and external faces.

Fig. 5: View of the LifePatch in place on a patient's chest, and connected to the external automated defibrillator. Legend for FIG. 5 [0013] 1. Transcutaneous Injection Module Data Integration and Control Module 2. Self-Adhesive Coating to Ensure Proper Patency on the Patient's Skin 3. Electrical Conduction Zone for Delivery external electrical shocks and external pacing 4. Module for capturing and collecting patient data: cardiac electrical activity and circulatory activity of the patient 5. Transcutaneous injection module of adrenaline with anode and cathode 6. Transcutaneous injection module amiodarone with anode and cathode 7. Communication connectivity between the integration and control module and the capture and data collection module 8. Communication connections between the transcutaneous injection modules and the integration and control module 9 Connectors for communication between the sternal patch and the automated defibrillator 10. Transcutaneous Magnesium Injection Module sium with anode and cathode 11. Transcutaneous injection module of another drug with anode and cathode 12. Connectors for communication between the apical patch and the automated defibrillator Embodiment of the invention [0014] FIG. 5 shows the device (LifePatch) in place, glued to the chest of a subject, and connected to an external automatic defibrillator (AED). The LifePatch consists of 2 patches whose structure is detailed in fig. 4.

These 2 patches are connected either via a housing to a conventional DAE device, or in the future, directly to a DAE of a next generation.

FIG. 4 shows the 2 LifePatch patches including a sternal patch (right) and an apical (left). Each of these patches is composed of a cutaneous surface (intended to be glued on the thorax of the subject) and an outer face.

The cutaneous surface contains: - a peripheral portion coated with glue to adhere firmly to the skin - a conductive area coated with a conductive gel, allowing the delivery of electric shock defibrillation and pacing - the face dermal transcutaneous drug injection modules (ionto / sono or ionto-sonophoresis) - the modules for capturing and collecting patient data: circulatory activity ... The external surface contains: - the data integration module and the control of transcutaneous injection modules - the different connections between transcutaneous injection modules, integration and control module

Example of LifePatch Operation: [0018] A patient presents discomfort in a public place, and loses consciousness. A witness then makes a call for help, puts the LifePatch patches on the patient's chest, in the same way that he would have placed those of a conventional AED,

Claims (8)

while continuing appropriate and recommended cardiopulmonary resuscitation (CPR) maneuvers. The device will then collect the patient's data: heart rate, circulatory activity, which he will analyze according to his algorithm. The analysis will reveal, for example, a circulatory arrest by asystole. The control module will then order the LifePatch transcutaneous injection module to perform an adrenaline injection, while ordering the witness to continue the CPR maneuvers (these voice commands already exist for current AEDs). This injection, which is more precocious than when the medical services arrived on the spot, will save precious minutes, thus conditioning the neurological prognosis of the patient. References [0019] [1] Rapid epinephrine administration improves early outcomes in out-of-hospital cardiac arrest. C. Koscika, A. Pi-nawinb, H. McGovemb, D. Aliene, D. E. Mediad, T. Fergusond, W. Hopkinse, K.N. Sawyera, J. Bouraf, R. Swora. Resuscitation 84 (2013) 915-920. [2] Association Between Timing of Epinephrine and Intact Neurology Survival Following Out-of-Hospital Cardiac Arrest in Japan: A Population-based Prospective Observational Study. S. Nakahara, J. Tornio, M. Nishida, N. Morimura, M. Ichikawa, T. Sakamoto. Emergency Medicine Academy 2012; 19: 782-792. claims 1. Automated resuscitation module: Iontophoresis / sonophoresis patches controlled by an automated defibrillator. These are skin patches intended to replace the patches / electrodes of the current automated defibrillators, and to perform also according to automated analysis algorithms of transcutaneous injections of resuscitation drugs. 2. LifePatch is composed of 4 parts: - A first part realizing the classic interface by patches between the defibrillator and the thorax of the patient in order to deliver the electric shock (s) if the analysis of the rhythm reveals a ventricular fibrillation. - A second part containing information collection modules: detection of cardiac electrical activity and circulatory activity (= this combination of the two techniques is a novelty because other defibrillators only analyze cardiac electrical activity) - A third composed part of the software module (contained in the hardware of the automated defibrillator) of analysis of the patient data and the therapeutic decision algorithm. The fourth part is composed of the accelerated transcutaneous administration module of the various drugs by iontophoresis, or sonophoresis or a combination of ionto-sonophoresis. 3. Drugs concerned by transcutaneous injections: adrenaline, amiodarone, glucose, isoprenaline, beta-blo-quant, magnesium, other cardiotropic medications, other emergency medications ... 4. LifePatch use situations: resuscitation of circulatory distress and / or vital distress requiring the injection of emergency medication (eg anaphylactic shock, cardiac arrest, symptomatic rhythm disorder ...). 5. The software automated decision algorithm allows the automated decision of administration or not (electrical shock (s) in case of ventricular fibrillation, external pacing in case of symptomatic bradycardia, drug (s) if necessary ...) depending on the patient's heart rate and circulatory activity. The software component is able to discriminate between "injectable and non-injectable" electrocardiographic rhythms in order to make a therapeutic decision. 6. Using the information collected by the circulatory activity analyzer to assess the effectiveness of external cardiac massage. 7. The device is made compatible with most existing automated defibrillators with in particular a software component for communication with the internal defibrillator software. The patches (Lifepatch) will be connected to the conventional automatic defibrillator via an adapter box, but can integrate directly with defibrillators of a future generation. 8. Recording of data: rhythms, pulse, shocks delivered, dose, schedules and intervals of medications injected, supported and possibility of remote transmission. 9. Additional sensors to acquire circulatory information of the patient: pulse, colorimetric plethysmography (possibly: approximate dosage of glucose).