WO2025032148A1

WO2025032148A1 - A device for providing resuscitation or suspended state in cardiac arrest

Info

Publication number: WO2025032148A1
Application number: PCT/EP2024/072382
Authority: WO
Inventors: Habib FROST
Original assignee: Neurescue Aps
Priority date: 2023-08-07
Filing date: 2024-08-07
Publication date: 2025-02-13

Abstract

Disclosed is a device for providing resuscitation or suspended state through redistribution of cardiac output in a human being, the device comprising - a elongated body extending between a proximal end and a distal end, the distal end being insertable into the mouth, pharynx, and esophagus of the patient, - wherein said distal end is configured with a diameter that is smaller than the diameter of the widest part of the elongated body, - wherein the elongated body is made from or encloses one or more high-density weighted element(s) that are movable radially relative to a line formed between a centre of the proximal end and a centre of the distal end of the elongated body, and - wherein said high-density weighted element(s) has/have a weight sufficient to be able to deflect the esophagus by applying gravitation-derived pressure against the dorsally facing surface of the esophagus when the device is introduced into the esophagus of a human subject placed on its back, and thereby provide redistribution of the cardiac output upon interaction between the esophagus and aorta.

Description

A DEVICE FOR PROVIDING RESUSCITATION OR SUSPENDED STATE IN CARDIAC ARREST

FIELD OF THE INVENTION

The invention relates to a device for providing resuscitation or suspended state in cardiac arrest, e.g., to increase return of spontaneous circulation (ROSC) or to expand the time window of intervention to enable new opportunities for diagnostics and treatments for patients in cardiac arrest.

BACKGROUND OF THE INVENTION

Cardiovascular disease contributes to 30.9% of global mortality. Currently, only 1 out of 10 survive a cardiac arrest to hospital discharge. It is responsible for higher mortality rates than any other disease in industrialized countries, and three-quarters of non-infectious mortality in developing countries. It is estimated that 7-9 million lives are lost annually due to cardiac arrest. The potential for improvement is massive.

By the early 1970s, CPR (Cardiopulmonary Resuscitation), defibrillation, and prehospital care were all in place. The introduction of automated defibrillation units (AED) expanded the possibility for prehospital treatment of cardiac arrest, and the first AED was successfully put to use by paramedics in Brighton in 1980. In spite of this, our current best practice only has the ability to achieve resuscitation, i.e., return of spontaneous circulation (ROSC), for around 25-30% of patients both in pre-hospital and in-hospital settings.

Today, large population studies show that only 20% to 30% of those suffering a cardiac arrest have a shockable rhythm as their initial rhythm. CPR and defibrillation are far from effective for everyone, even when stratifying for shockable vs non-shockable patients. Roughly stated, electricity cannot open an occluded coronary artery or increase blood supply to the brain and heart when it is insufficient to achieve resuscitation. There is rarely enough time to diagnose and treat the underlying cause of the cardiac arrest, and even defibrillation depends on optimizing hemodynamic variables beforehand. From other patient settings we know of and perform time-consuming treatments that could potentially save the patient's life but cannot currently be performed within the time constraints of a cardiac arrest.

The low proportion of shockable patients also has wide implications. We can try to defibrillate a shockable rhythm, but we have no truly effective treatments otherwise. CPR and Defibrillation have been virtually unchanged since their implementation. CPR cannot generate sufficient cerebral blood flow to preserve normal cerebral viability until cardiac function is restored. This explains why cardiac arrest has such high neurological morbidity and mortality. Therefore, we need new solutions to improve cerebral blood flow and subsequent neurological outcome from cardiac arrest, especially if we want to do more efforts than defibrillation. Even if only defibrillation is performed, new solutions to improve coronary blood flow can improve the likelihood of success from defibrillation.

As an example, coronary artery disease represents the most common cause of out-of- hospital cardiac arrest, but the treatments, e.g., percutaneous coronary intervention (PCI), cannot be performed within the time limits of current CPR, and the patient experiences insufficient blood supply to the brain and heart until the definitive treatment is performed.

Cooling (therapeutic hypothermia) has only proved useful in the patients who have already achieved a return of heartbeat, so-called ROSC (return of spontaneous circulation), and does not alter the proportion of those who achieve ROSC. Cooling slows down the cellular demands - cerebral metabolic demands lower by about 8% per degree Celsius drop in temperature - but it usually takes hours to reach the desired temperature and is therefore not an effective way to bridge the patient in cardiac arrest to definitive treatment. By then, the patient is already irreversibly neurologically damaged.

Late therapy like cardiopulmonary bypass, ECMO (extra corporeal membrane oxygenation), and/or other percutaneous cardiac support devices, no matter how good, are not effective once the ischemic capability of the heart and brain is exceeded. Nevertheless, recovery may be improved by these devices, which unfortunately cannot be initiated fast enough in cardiac arrest and cannot be delivered by laypersons, paramedics, or emergency medical technicians (EMTs), to replace the need for intermediate solutions.

Recently, the development of fluoroscopy-free balloon catheters has allowed specially trained physicians to treat select patients without the logistically demanding requirement of fluoroscopy. However, there still exist significant bottlenecks, e.g., geographically, economically, and logistically, in bringing these highly specialized physicians to cardiac arrest patients within the therapeutic time window, and only paramedics, EMTs, and/or laypersons are able to reach the far majority of these patients in due time.

A feasibility study showed that specially trained physicians delivering a femoral-artery-based at least partial obstruction within the descending aorta by inflating a balloon to a maximum possible diameter of 20 mm (in adults with a typical aorta diameter up to 30 mm) was able to facilitate resuscitation, i.e., ROSC, in 6 out of 10 subjects that were otherwise refractory to standard care (J Am Heart Assoc. 2019;8:e014394).

Proposals that require the placement of a front or back plate on the body, e.g., to press the body, prevent or interfere with the delivery of chest compressions (particularly the relaxation phase of the compression cycle), to the detriment of the patient, even more so when delivering CPR with a mechanical chest compression system (that requires placement where such front- or backplated device(s) are proposed to be placed). Chest compression devices with a back plate are now used extensively as part of paramedic/EMT-provided CPR, who provide the majority of advanced life support care globally. The more time-consuming a proposed emergency procedure is, and the higher number of user steps, the potential benefit is adversely affected, and the error potential increases.

OBJECTS OF THE INVENTION

It is an object of embodiments of the invention to provide a device or a system that enables blood redistribution in a patient suffering from cardiac arrest, so as to render heart massage (chest compression) more effective in maintaining the vital perfusion of the brain and heart. It is furthermore an object of the embodiments of the invention to provide a device that can be operated by paramedics, EMTs and/or laypersons. It is also an object of embodiments of the invention to provide a device by which ease-of-use and built-in safety can help mitigate for potential adverse events effect of a such cardiac output redistribution and thereby enable solutions for providing resuscitation or suspended state. It is further an object to provide a device by which a patient can be treated in both the near-community, pre-hospital and in- hospital settings, in the hands of users with minimal training, to thereby allow not only in- hospital physicians but also paramedics, EMTs, and/or laypersons to carry out such procedures to achieve an expansion of the time window to reverse a cardiac arrest, or improve the likelihood of success from immediate defibrillation.

Particularly, it is an object of embodiments of the invention to enable the delivery of diagnostics and treatments that cannot currently be delivered to patients in cardiac arrest, where almost universally only defibrillation and drug administration can be achieved within the current therapeutic time window. SUMMARY OF THE INVENTION

It has been found by the present inventor that a main problem during cardiopulmonary resuscitation (CPR) of cardiac arrest patients is the fact that non-vital organs and tissues are perfused and supplied with oxygenated blood at an, under these circumstances, unnecessary high level and that this happens at the expense of in particular the brain and the heart, which in contrast to these non-vital organs and tissues are much more sensitive to the lowered perfusion. Further, it has been found that if this imbalance during CPR could be changed to favor the perfusion of the brain and the heart, then the chances of survival of these patients would be greatly enhanced. However, it is normally necessary to perform a percutaneous intervention in order to establish preferential perfusion of the brain and heart in a patient and this percutaneous intervention requires the skills of a specialist physician.

On the other hand, staff of rescue teams are normally not specialist physicians so it would be advantageous to be able to provide a device or system, which via a very simple intervention - which does not require surgical skills - can bring about the advantageous preferential perfusion of brain and heart.

The present inventor has hence realized a novel technological appliance. Unlike cooling, were the metabolism of the cells is slowed down, which cannot be initiated fast enough if the cardiac arrest has already occurred, we introduce 'suspended state', where the neurological damage process itself is put to a halt, by controlled redistribution of the cardiac output from chest compressions to the brain and heart - to create an increasing metabolic debt to the tissues that can tolerate this state, thus still keeping every single cell in the body viable.

The use of a supraceliac aortic occlusion can increase the coronary and cerebral perfusion pressure with about a 100%, thus reaching viable levels again. We observe this in the delivery of femoral-artery-based at least partial obstruction within the descending aorta, and that the remaining organs can tolerate this intervention for some time. However, invasive percutaneous aortic interventions via a blood-contacting catheter require an extensive set of clinical competencies reserved almost exclusively for specially trained physicians.

Paramedics and EMTs are taught procedures such as insertion of supraglottic airways and bag mask ventilation with relative ease and perform these procedures routinely as part of their care of emergency patients. The esophagus and larynx are situated in the neck. It requires specific intent to ensure that a given device gets positioned in or faces towards the larynx, and not the esophagus, since the larynx is positioned anterior to the esophagus, and a more difficult "U" shape needs to be achieved in order to enter the larynx. This is to say that paramedics/EMTs could place a device inside the esophagus easier than the airway procedures that paramedics/EMTs already perform routinely. The esophagus is an elastic tube located behind the trachea, runs down the neck and chest, responsible for transporting food and liquid from the mouth to the stomach. The trachea is positioned in front of the esophagus and serves as the airway for breathing.

The aortic arch is a curved part of the aorta that originates from the heart and then arches over the heart. The aorta then descends behind and crosses under the esophagus in a tall X- styled fashion. The esophagus crosses directly in front of the aorta.

The aorta is the largest artery in the body. The aortic arch supplies blood to heart, head, and arms. The aorta curves up in front of the esophagus, then descends downward behind the esophagus, and crosses under the esophagus, whereafter it branches out to supply blood to the rest of the organs and tissues throughout the body.

In the present invention the following, amongst other aspects, is uniquely utilized :

The esophagus is not located in front of the heart and the aortic arch (which supply the brain and the heart itself), then the esophagus crosses over just in front of the aorta, before the aorta supplies the remainder of the body, which is less critical in its receival of blood supply during CPR. There is a direct proximity between the elastic tubular tissue of the esophagus and the elastic tubular tissue of the aorta (as illustrated in Fig. 1).

The esophagus is typically 23 to 25 cm long in adults, with sphincters located in its proximal and distal ends, a mucosa-lined lumen and smooth muscle outer layer. The distance from the teeth to the aortic arch is typically 25 cm. The distance from the teeth to the esophageal hiatus (the entrance to the stomach) is typically 40 cm.

The muscle tonus of the esophagus is severely reduced during cardiac arrest, as verified by the high incidence of pulmonary aspiration in the peri-CPR setting. Therefore, the mechanical tissue resistance through the oesophageal wall is minimal in the cardiac arrest patient.

The esophagus can be stretched to accommodate various intended effects, and the normal unstretched esophagus diameter measures up to 30 mm, which corresponds to the normal diameter of the (abdominal) aorta at up to 30 mm.

Unlike many patients who may sit upright or slightly upright, a cardiac arrest patient is placed in the supine (flat position), or near-supine position, as a strict requirement to perform CPR. The supine position allows for the opportunity to use gravitational force as a powerful ally in the non-permanent augmentation of anatomical features in achieving an emergency medical redistribution of blood supply. Patients who are in cardiac arrest, a highly time-critical medical emergency, do not present with a neurologically functioning gag reflex. This can be utilized to immediately perform non- invasive procedures, e.g., by paramedics/EMTs, without limited time and resources taken away to firstly perform sedation or anesthesia, and also allows laypersons to immediately perform such non-invasive procedures, since they cannot administer sedation/anesthesia.

Abovementioned aspects are utilized by the present inventor as part of novel devices for treatment, e.g., to increase immediate resuscitation, alternatively to 'bridge' cardiac arrest patients to definitive treatments, alternatively used as part of 'bridge to bridge' therapies to other bridge therapies such as ECMO, and subsequently definitive treatment. These devices are aimed to be operatable by the providers who deliver the first-response emergency care for patients in cardiac arrest, and not only operatable by specialist physicians.

To enable safe redistribution of emergency blood supply, for non-medical practitioners or semi-skilled practitioners, the present invention hence provides in a first aspect a device for for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient, the device comprising a manually controllable redistribution component in the form of an elongated body attachable to the patient and being configured to interact with the patient to provide redistribution of the cardiac output to increase supply to the brain and heart.

The elongated body extends between a proximal end and a distal end. The distal end is insertable into the mouth, pharynx, and esophagus of the patient, and said distal end is configured with a diameter which is smaller than the widest part of the elongated body. The elongated body is made of one or more high-density weighted element(s) that are movable radially to a line formed between a centre of the proximal end and a centre of the distal end of the elongated body.

The high-density weighted element(s) are configured to exercise a weight onto the aorta, which bends the aorta at one or more contact points to at least partially collapse its lumen as a response to the weight bearing, said at least partial lumen collapse redistributing flow to increase supply to the brain and heart for the patient.

To provide the combination between a large weight, a small volume, and biocompatibility, the high-density weighted element(s) optionally comprise, or allows the insertion of, at least partially one or more of the following : Tungsten, platinum, gold, silver, rhenium, iridium, osmium, palladium, bismuth, steel, cobalt, gadolinium, tantalum, niobium, molybdenum, hafnium, zirconium, neodymium, chromium, nitinol, iron or steel. The high-density weighted element(s) may be configured to be insertable into the esophagus with a diameter up to 45 mm.

The distal end may be configured as a tip with an atraumatic shape, including e.g., an oliveshaped tip, a coude tip, a spherical tip, an ellipsoid tip, a conical tip, or variations thereof that closely approximate these shapes. The tip material may be comprised of a low-durometer polyurethane that is soft and flexible, or another appropriate material that is soft, pliable, and appropriate for tissue contact, e.g., 70 Shore A polyurethane.

The device comprises high-density weighted element(s) that are movable radially to a line formed between the centre of the proximal end and distant end of the elongated body (hereafter referred to as "the line") configured to accommodate the passage from the teeth and into the esophagus, which is not a straight line. In one embodiment of the invention said radial movement is achieved by configuring the device with mechanical properties wherein at least one or more parts of the device is not rigid. This may be achieved with e.g., links between the high-density elements, such as seen between individual parts in jewelry bracelets and/or with e.g., placing the element(s) in a chain, so as to facilitate movement in relation to each other, .e.g., with a carabiner hook built into or attached to each element. In another embodiment the weighted (s) occupy the inner volume of a flexible tube, each end of the tube comprising or is attached to the distal and proximal end of the device, which allows the weighted element(s) to move radially in a line formed between the centre of the proximal end and the centre of the distal end of the device. In another embodiment one or more weighted element(s) are placed onto e.g., a guidewire or tube that is non-rigid. This allows for the weighted element(s) to move radially in relation to the line. In one embodiment a tubular structure surrounds the high-density weighted element(s) with an elasticity configured for the element(s) to gravitationally move relative to the position of the remainder of the device, while still permitting the weighted element(s) to be inserted and pulled out together with the encompassing structure of the tubular structure. This tubular structure may be comprised of silicone, polyurethane, latex, or another elastic material.

In one embodiment the device comprises high-density weighted element(s) that are at least partially configured with a density that is higher than at least partially the remainder of the device, said remainder of the device may e.g., be comprised of a coating onto the device, be comprised of e.g. a tubing, wire, or another member, on the surface of or inside the device, be comprised of the attachment mechanism and/or distal end, including e.g., a tip.

The device may be configured so that at least part of the device is configured with a shape that stabilizes and eliminates the potential for rotation of the device within the mouth, pharynx and/or esophagus, e.g., with a shape that is wider than it is deep, so that e.g., conforms to the shape of the mouth and/or pharynx during and/or after insertion. The proximal end of the device (which is closer to or positioned inside and/or through the mouth) may comprise a shape that is wider than it is deep, e.g., 3-5 cm in width and e.g., 1 cm in depth, which is a shape for which it is difficult to accomplish a rotation inside the mouth, as compared to a totally cylindrical shape of the proximal end of the device with e.g., a 2-3 cm diameter. This is due to the shape matching the overall typical shape of the oral cavity.

The device may be configured with a securement mechanism to prevent displacement of the device through the mouth of the patient, said securement mechanism optionally comprising of or is attachable to at least one or more of the following : a handle, a stop block, a bite block, a string, a guidewire, a tubing, a catheter, an adhesive, a mask, a mouthpiece, a strap, a harness, an airway device, including supraglottic airway devices, an endotracheal tube, the patient's skin, teeth, tongue, bed, gurney and/or stretcher.

The securement mechanism may be comprised of one or more of the following : A handle that can be held by the operator, a stop block that is volumetrically too large to enter the mouth of the patient, a bite block that can be anchored to or between the teeth of the patient, a string that can be attached to another device or object, e.g., be tied around an airway device already placed through the mouth of the patient, or to be placed through the mouth of the patient, securement onto over a guidewire that has already been placed inside the patient and/or is due to be positioned into the patient, the proximal end may be comprised of a tubing or catheter that itself can be attached to another device or object. The securement mechanism may be attached to a mask, e.g., a bag mask ventilation mask. The mechanism may be attached to a mouthpiece, e.g., used to protect the teeth of the patient. The mechanism may be attached to airway devices used as part of the medical emergency and/or onto the surface on which the patient is placed, e.g., a bed, gurney and/or stretcher.

The attachment within the securement mechanism between all aforementioned surfaces, objects and/or devices may be accomplished with a lock, fixture, fastener, glue, adhesive, zipper, magnet and/or other connection forms apparent to those skilled in the art.

This securement mechanism may in one embodiment be accomplished with e.g., a rigid polypropylene (or another polymer) plate in the shape of flat circle with a diameter of 6 cm and a thickness of 1 mm, which prevents the securement mechanism from entering the mouth of the patient.

In another embodiment the high-density weighted element(s) can be positioned inside or onto a stem such that the elongated body comprises the stem and the high-density weighted elements carried by the stem. The high-density element(s) may be positioned inside e.g., an outer tube which then constitutes the stem. In that embodiment, the high-density weighted elements will be placed together with the tube in the esophagus. This tube may be comprised of a polymer, including an elastic polymer. The element(s) may also have e.g., a hole in the middle, which can be used to place the element(s) over e.g., a tube or wire. Thus, the tube or wire can comprise the elongated body of the device. In another embodiment the member over or inside which the high-density weighted element(s) have been placed together comprise the elongated body of the device. In another embodiment the remaining surface of the elongated body and/or the space between the stem of the device and the weighted element(s) are filled out with or coated with another material, e.g., to achieve increased biocompatibility or lubriciousness. Such a coating may be e.g., a parylene coating for increased biocompatibility, or a coating for lowering friction such as e.g., polyurethane, polyacrylic acid, polyvinylpyrolidone, polyethylene oxide and/or polysaccharide materials.

In an embodiment the high-density weighted element(s) are configured with a shape to optimize the contact pressure between the weighted element(s) and downwards facing tissue(s) (the direction of gravity being downwards), e.g., a triangular profile or pyramidal frustum while ensuring there is a protrusion, as compared to the rest of the element, which is downwards facing towards the aorta and away from the sternum, which directs the force of the weight towards the aorta onto a smaller or narrower surface area, or another optimized shape to optimize the contact pressure between the element(s) and the downwards facing tissue(s) as will become apparent to those skilled in the art from this description. Said shape may additionally be configured to aid in preventing rotation of the member circumferentially.

In one embodiment the high-density weighted element(s) are configured with an at least partially rounded or atraumatic shape, coating or covering in the surface facing towards the esophagus when inserted into or positioned against the esophagus in the caudal direction of the esophagus and/or configured with an at least partially rounded or atraumatic shape, coating or covering in the surface facing towards the esophagus when removed from or positioned against the esophagus in the cranial direction of the esophagus. Such overall shapes are non-linear and rounded, e.g., such shapes can e.g., be segments of and/or entire spheres or ellipsoids.

In another embodiment said high-density weighted element(s) are configured with an at least partially rounded or atraumatic shape and/or coating and/or covering in the surface facing towards the esophagus when inserted into or positioned against the esophagus in the caudal direction of the esophagus and/or configured with an at least partially rounded or atraumatic shape and/or coating and/or covering in the surface facing towards the esophagus when removed from or positioned against the esophagus in the cranial direction of the esophagus. The device may additionally be configured with flexibility and/or damping means, which can be achieved by configured the device to at least partially comprise of a compressible material such as e.g., a foam or rubber, e.g., a polyurethane.

In a related embodiment the high-density weighted element(s) are configured with a surface and/or material and/or shape to facilitate CPR being performed concurrently with the device's placement inside the esophagus while minimizing tissue injury from the cyclical loading and unloading from the external force of chest compressions being performed at a frequency of e.g., 100-120 per minute. This can be achieved by e.g., configuring the device with materials with high fatigue strength and fatigue resistance, such as e.g., certain alloys (such as nitinol), or composite materials; by configuring the device with smooth transitions avoiding sharp notches/corners and/or avoiding changes in geometry that can create edges, onto which the cyclic loading and unloading from the chest compressions could injure tissue(s), e.g., tear or cut tissue(s); by configuring the device with a smooth and/or low-friction surface material and/or coating, such as e.g., polytetrafluoroethylene; by configuring the device with rounded edges in areas of high stress concentration; by configuring the device with flexibility and/or damping means to absorb and dissipate energy from cyclic loads, which can be achieved by configured the device to at least partially comprise of a compressible material such as e.g., a foam or rubber, e.g., a polyurethane; by configuring the device with optimized geometry configured to minimize stress concentrations. In one preferred embodiment the upper surface (facing towards the sternum) has a wide, rounded surface without any sharp angles, protrusions or transitions, whereas the lower surface (facing towards the aorta) has a narrower surface/narrower rounded protrusion, such that the energy from the CPR is dissipated across a large surface area on the upwards surface, whereas the gravitational force from the weight of the device itself and additionally, at least partially, including the force exerted from the chest compressions, is spread across a large, at least partially rounded surface area upwards, whereas the force facing downwards is concentrated onto a smaller surface point, area and/or ridge, from which a higher pressure is exerted towards the downwards facing tissue(s), .e.g. in the shape of a rounded triangular prism, alternatively a (rounded) triangular profile or pyramidal frustum. Said shape(s) may additionally be configured to aid in preventing rotation of the member circumferentially.

In one embodiment the device is configured with a retrieval mechanism in case of accidental -or alternatively intentional - detachment of at least part of the device into the esophagus and/or stomach, e.g. comprising of a hook, hole, magnetic connection or other means for (re)connecting to the device after said detachment, e.g. the device comprises a hole enabling for the device to be retrieved via the use of an endoscope which attaches itself to the device and by withdrawal of the endoscope, the device is withdrawn out of the body as well.

In another embodiment at least part of the device may be configured with a shape to facilitate that at least part(s) of the device, or the device as a whole, can be expelled from the body through the natural digestive process, and/or emesis: This may .e.g., be achieved by having the device consist of very rounded ellipsoid(s) .

Said high-density weighted element(s) can be configured in such a way that the shape(s) and weight(s) exercise a gravitational force onto the aorta that fulfils universal threshold values not directly connected to individual variations between each patient, e.g., 5N-10N. In one embodiment said high-density weighted element(s) are comprised of tungsten in a sufficient volume (either as individual smaller pieces placed adjacently or as one large object), or another weighted high-density material of sufficient volume, e.g., a cylinder with a diameter of 3.0 cm, and a length of 5.0 cm, thus achieving a volume of 35,3 cm³. With the density of pure tungsten at 19,3 g/cm³, this achieves a weight of the weighted tungsten element at 681,3 g, equivalent to a force of 6,68 N.

The edge of the cylinder can be configured to exercise a contact force along an edge, e.g., via a protrusion that is 40 mm long and 2 mm wide (a surface area of 0.8 cm²). The weight onto the contact surface would thus exercise a pressure of 626 mmHg. This pressure far exceeds, more than lOx, the aortic pressure during CPR at typically only 50 mmHg.

In one embodiment, the high-density weighted element(s) optionally at least partially comprise, or allows the insertion of, one or more of the following : Tungsten, platinum, gold, silver, rhenium, iridium, osmium, palladium, bismuth, steel, cobalt, gadolinium, samarium, tantalum, niobium, molybdenum, hafnium, zirconium, neodymium, chromium, nitinol, iron, steel, mercury. In one embodiment, a liquid, powder, pellets and/or a putty may be inserted into the device after it has been inserted, hence here the device is configured to 'allow the insertion of' high-density weighted element(s), if not already present in the device prior to patient use.

The esophagus has a sphincter in each end. In one embodiment of the invention, the distal end of the device is configured with an at least partially rounded or atraumatic shape, coating or covering in the surface facing towards the esophagus when inserted into or positioned against the esophagus in the caudal direction of the esophagus and/or configured with an at least partially rounded or atraumatic shape, coating or covering in the surface facing towards the esophagus when removed from or positioned against the esophagus in the cranial direction of the esophagus. The configuration in this embodiment thus aids in the protection of the esophageal tissue in an atraumatic fashion.

In one embodiment, the proximal end and/or the distal end and/or the elongated body of the device is at least partially comprised of or enclosed by one or more polymer(s), optionally including e.g., one or more of the following : Silicone, polyurethane, polyvinylchloride, rubber, polyethersulfone, polytetrafluoroethylene, nylon, polyethylene, polyetherimide, polycarbonate, polysulfone, polyetheretherketone, polypropylene, acrylonitrile butadiene styrene and/or styrene ethylene butylene styrene. In this embodiment, the device configured with one or more polymer(s) gives the device properties which the material(s) of the high- density weighted element(s) cannot, e.g., lower the friction of the surface of the device and/or increase the lubricity of the device and/or decrease the hardness of the surface, and/or increase the elasticity of the device and/or increase the biocompatibility of the device.

In one embodiment the device at least part of the shape of the device is configured to follow a pre-formed curve or bend. This is a configuration which accommodates the anatomy of the passage from the teeth into the esophagus, which has the approximation in its shape of a quarter of a circle.

The term "redistribution" is in the present context intended to mean an intervention (preferably mechanical) that ensures that the cardiac output is preferentially directed to the brain and the heart in order to supply these two organs with sufficient perfusion of (oxygenated) blood at the expense of perfusion of other organs that are not highly supply sensitive over a limited time span.

The term "suspended state" is meant to denote a state in a cardiac arrest patient or other patient who is undergoing or to undergo treatment, where neurological damage processes are put to a halt by controlled redistribution.

The term "atraumatic" is meant to denote a shape or form that is configured to be non- injurious when touching a tissue surface. It is most commonly achieved in the state of the art with an at least partially rounded shape, e.g., a sphere or ellipsoid, however, even if a shape approximates an at least rounded shape by way of one or more polygon types, to achieve an approximation to an at least rounded shape, this shall be considered as an at least rounded shape, and such variations are incorporated in the definition of an "at least partially rounded shape" in the present application. The term "to bridge" is in the present context intended to mean an allowance to expand the time window of intervention for the patient to allow time for diagnostics and treatments and/or as an allowance to transport the patient from one physical location to another and/or an allowance to transfer the patient between the care of different professional groups of people.

The term "attachable" is in the present context intended to mean a tissue-device connection that allows for an interface of one the following : Outside a patient, onto a patient, through a body opening, puncture, surgical site and/or an interface that is implanted in the patient.

The elongated body can interact with the patient to provide a predetermined redistribution of the cardiac output in a predictable fashion based on predetermined characteristics of the device, which can provide a well-known and expected result.

If the high-density element(s) are volumetrically small, e.g., the size of powder, pellets, or granules, it is understood that the overall volume(s) that these high-density weighted element(s) occupy, either partially or totally, is to also be understand as the 'high-density weighted element' as variations of all the described possible embodiments where 'high- density weighted element' is described herein.

The weight of the high-density weighted element(s), e.g., each separately or in total, aids in the correct insertion and positioning of the device into the esophagus of a patient placed in a supine or near-supine position, since the gravitational force brings the device closer to the esophagus and steers it away from entering the larynx

The device may be used in e.g., the following protocol, which specifies:

1) Initiate and continue either manual or automatic chest compressions. 2) Attempt defibrillation of the patient. 3) Cardiac arrest is either non-shockable or does achieve ROSC as a response to the defibrillation attempts. Decision to use the device of the invention. 4) Insertion of the device. 5) Attempt to defibrillate the patient again with the improved hemodynamics after device insertion. 6) If unsuccessful, administration of a vasopressor, e.g., vasopressin. This is a clinical decision based on the presumed underlying cause of the cardiac arrest, e.g., anaphylaxis. Repeat administration periodically. Alternatively, administration of a vasodilator, e.g., sodium nitroprusside. This is a clinical decision based on the presumed underlying cause of the cardiac arrest, e.g., refractory coronary artery disease. Potential periodic repetition of either drug type. 7) Cardiac arrest won't revert => Decision to put the patient in 'suspended state'. 8) Potential application of a 20-60-degree head-up tilt.

9) Potential application of intravascular cold saline solution and/or surface cooling pads on body and/or hypothermic total liquid ventilation and/or administration of muscle relaxant. 10) Potential administration of a vasodilator, e.g., sodium nitroprusside, to improve suspended state microcirculation. Potential periodic repetition of vasodilator administration. 11) Transport to Hospital. 12) Initiate in-hospital cardiopulmonary bypass, ECMO or deliver e.g., PCI treatment directly. 13) Potential plasmapheresis or dialysis. 14) Achieve return of patient heartbeat with other means possible. 15) Continuation of cooling for additional time after return of heartbeat. 16) Prognosticate the patient after at least 24-72 hours of sustained therapy. 17) Continuous monitoring of treatment.

They device may at least partially be comprised of non-rigid materials, which facilitate that the device can stretch and deform during insertion into and/or through the mouth, pharynx and/or the esophagus, and at least partially can regain at least part its original shape thereafter. This allows the high-density weighted elements to temporarily displace and distance themselves further from each other, as in the fashion of e.g. solid beads on an elastic bracelet, during the insertion and regain their proximity to each other after the insertion has been completed. This may also help facilitate re-positioning of the device after some time has passed, or in the event there is clinical suspicion that the position is not optimal and can then be optimized. The non-rigid materials could be chosen from e.g., a wide number of biocompatible polymeric plastic materials.

In one embodiment the high-density weighted elements are mechanically interlinked. Such interlinking can be configured so that an opening in one weighted element fits a part of another weighted element, or vice versa, or variations thereof with other mechanisms for mechanically linking physical objects.

This device is useful not only in patients that have suffered a cardiac arrest but also in patients where the supply of oxygenated blood to the brain and heart is inadequate for other reasons. An example is a patient having a severe asthma attack - wherein oxygenation is significantly impaired, but typically does not cease completely - the device of the invention could provide for prioritized distribution of the reduced amount of oxygen, which is available while the patient's respiratory system is compromised during the asthma attack.

METHODS

The presently described device is useful in methods for providing resuscitation or suspended state in a human cardiac arrest patient, said method comprising subjecting the patient to heart massage (chest compressions which may be accomplished manually or by use of a mechanical chest compression device), while at the same time ensuring redistribution of the cardiac output to preferentially supply blood to the brain and the heart. In other patients, where the heart action is not compromised, but where the heart and/or brain receives insufficient amounts of oxygenated blood such as in patients suffering from critical bleeding or severe asthma attacks, the chest compressions are dispensed with, and it is only necessary to ensure proper redistribution of the blood flow.

In a method for resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient, a patient is subjected to external chest compression while at the same time inserting a device (such as a device of the present invention) into the esophagus, said device exercising a weight onto the aorta, which bends the aorta at one or more contact points to at least partially collapse its lumen as a response to the weight, said at least partial lumen collapse redistributing flow to increase supply to the brain and heart for the patient, wherein the redistribution facilitates ROSC, and/or acts as a bridge to at least one or more of the following : ECMO, ECLS and/or cardiopulmonary bypass; therapeutic hypothermia; angioplasty, including PCI and angiography; dialysis; administration of drugs such as vasopressors, thrombolytic drugs such as fibrinolytics, fluids, bicarbonate, antidotes, and antiarrhythmic drugs; the use of ultrasound, X-ray, CT, or MR; intubation; mechanical ventilation; ventricular assist devices; heart transplantation, CABG surgery, valve surgery; blood transfusion; placement of external or internal pacemaker or ICD; catheter ablation; thromboendarterectomy; defibrillation; transportation. In other words, the method may bridge the patient to and thereby enable and/or be combined with and enable novel bridge therapeutic processes.

In one embodiment a method is provided for stopping or reducing bleeding from tissue(s) or organ(s) caudal to the aortic level of the redistribution, hereunder during e.g., surgery or other situations where bleeding occur from said tissue(s) or organ(s), the method comprising inserting a device (such as a device of the present invention) into the esophagus, said device exercising a weight onto the aorta, which bends the aorta at one or more contact points to at least partially collapse its lumen as a response to the weight, said at least partial lumen collapse redistributing flow to increase supply to the brain and heart for the patient.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In the following, embodiments of the invention will be described in further details with reference to the drawing in which:

Fig. 1 illustrates the anatomic relationship between the esophagus, aorta, and trachea.

Fig. 2 illustrates a device according to the invention positioned in the esophagus. Fig. 3 illustrates a device according to the invention.

Further scope of applicability of the present invention will become apparent from the following detailed description and specific examples. However, it should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration only, since various changes and modifications within the scope of the invention will become apparent to those skilled in the art from this detailed description.

Fig. 1. The esophagus 3 is an elastic tube located behind the trachea 4, responsible for transporting food and liquid from the mouth to the stomach. The trachea serves as the airway for breathing.

The aortic arch 1 is a curved part of the aorta 2 that originates from the heart. The aorta 2 then descends behind and crosses under the esophagus 3 in a tall X-styled fashion. The esophagus crosses over just in front of the aorta. There is a direct proximity between the elastic tubular tissue of the esophagus 3 and the elastic tubular tissue of the aorta 2.

Fig. 2. Illustrates a device 5 according to the invention positioned inside the esophagus 3. The device exercises a weight onto the aorta 2, via the esophagus, which collapses its lumen as a response to the weight bearing, said lumen collapse redistributes blood flow to above the device (blood flow to the brain and heart which is supplied by the aortic arch) and precludes it from passing down below the device (into the lower body).

Fig. 3. Illustrates a device according to the invention. An attachment mechanism is positioned by the dashed line 6 topmost in the figure. This attachment mechanism is built into the proximal end of the device. There is an interspaced segment 7 between the proximal end and a conical segment 8, which has a narrower diameter than the widest part of the device, prior to reaching the first high-density weighted element 9. This element is comprised of pure tungsten and is shaped as an ellipsoid, enclosed by an elastic polymer tube extending along the entire length of the device. In between the first weighted element 9 and the second weighted element 10 are found repeating segments 11 with a lower diameter than the diameter of the tungsten ellipsoids. The repeating segments 11 are comprised of foam and surrounded by the elastic tube extending along the entire length of the device.

The distalmost weighted element 12 is attached to a conical member 13 at the distal end of the device. This distal end 13 is additionally comprised of an atraumatic tip 14 (in the shape of a superegg). Both the conical shaped member 13 and the tip are made of polyurethane. The total length of the device (incl. the attachment mechanism) is 50 cm. It is configured to be passable along the entire esophagus (the distance from the teeth to the esophageal hiatus (the entrance to the stomach) is typically 40 cm). The high-density weighted elements are placed along the 25 to 50 cm mark of the device (since the distance from the teeth to the aortic arch is typically 25 cm).

Expectedly, the device may include variation(s) of the above configurations.

EXAMPLE 1

Operation of a device of the invention

A state-of-the-art tissue-equivalent aortic model (NTM00V02, United Biologies) was used as part of the test. A force meter was used to determine the force required to collapse the aortic lumen from outside of the aorta from the anterior position (from the relative position of the esophagus), and the recorded value was 5N, equivalent to a weight of 0.5 kg. A flexible latex tube with a diameter of 20 mm and a wall thickness of 0.5 mm was used to encapsulate two high-density tungsten cylinders (99.95% tungsten), each measuring 32 mm x 32 mm and weighing 488 grams. The tubing narrowed proximal and distal to the cylinders, which thereby created atraumatic cone shapes in between each cylinder and in each end of the tube as compared to the edges of the cylinders. Furthermore, the tubing facilitated the positioning of the tungsten cylinders onto a contact surface on the anterior wall of the aorta, which bent the aortic wall and collapsed its lumen as a response to the weight bearing.

NUMBERED ITEMS

The invention relates to the following consecutively numbered items:

El. A device for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient, the device comprising an elongated body attachable to the patient and being configured to interact with the patient to provide redistribution of the cardiac output to increase supply to the brain and heart,

- the elongated body extending between a proximal end and a distal end, the distal end being insertable into the mouth, pharynx, and esophagus of the patient, wherein said distal end is configured with a diameter which is narrower than the widest part of the elongated body

- one or more high-density weighted element(s) that are movable radially to a line formed between a centre of the proximal end and a centre of the distal end of the elongated body,

- said high-density weighted element(s) are configured to exercise a weight onto the aorta, which bends the aorta at one or more contact points to at least partially collapse its lumen as a response to the weight bearing, said at least partial lumen collapse redistributing flow to increase supply to the brain and heart for the patient, wherein said high-density weighted element(s) optionally comprise, or allows the insertion of, at least partially one or more of the following : Tungsten, platinum, gold, silver, rhenium, iridium, osmium, palladium, bismuth, steel, cobalt, gadolinium, tantalum, niobium, molybdenum, hafnium, zirconium, neodymium, chromium, nitinol, iron or steel.

E2. The device according to item El, where at least a part of the device's surface is configured to accommodate to external pressure exerted on the outer surface of the device, thus configured to reduce the risk of damage onto tissue.

E3. The device according to any of the preceding items, further comprising an internal lumen configured for the passage of fluids and/or drugs into and out of the esophagus.

E4. The device according to any of the preceding items, wherein the high-density weighted element(s) are of different sizes configured to facilitate a stepwise increased stretching of the esophagus in an incremental fashion.

E5. The device according to any of the preceding items, further comprising an opening configured for insertion with or over a stylet or guidewire, to position the device at least partially inside the esophagus, thus aiding with the insertion/passage into the esophagus, as compared to direct device insertion.

E6. The device according to any of the preceding items, further comprising a lighter-weighted guide structure that has been inserted at least partially into the esophagus first, whereafter the heavier device is passaged at least partially into the esophagus, thus aiding with the insertion/passage into the esophagus, as compared to direct device insertion.

E7. The device according to any of the preceding items, wherein said high-density weighted element(s) are configured to be insertable into the esophagus with a maximum diameter such as 44, 43, 42, 41, 40, 39, 38, 37, 36, 35, 34, 33, 32, 31, 30, 29, 28, 27, 26, 25, 24, 23, 22, 21 and 20 mm.

E8. The device according to any of the preceding items, wherein the high-density weighted element(s) are configured with a minimum weight of 1000, 900, 800, 750, 700, 650, 600, 550, 500, 450, 400, 350, 300, 250, 200, 150, 100 g. E9. The device according to any of the preceding items, wherein the diameter of the device increases gradually and/or stepwise across the elongated body of the device configured to facilitate a gradual and/or stepwise increased stretching of the esophagus in an incremental fashion. E10. The device according to any of the preceding items, wherein the diameter of the device both increases and decreases gradually and/or stepwise across the elongated body of the device configured to facilitate momentary higher and lower stretch(es) of the esophagus as the device passes through narrower parts of the esophagus.

Ell. The device according to any of the preceding items, wherein said high-density weighted element(s) are comprised of least one or more of the following: a powder, pellets, granules, ellipsoids, spheres, cuboids, pyramids, cones, frustum, cylinders and/or malleable putty.

E12. A method for stopping or reducing bleeding from tissue(s) or organ(s), hereunder during e.g., surgery or other situations where bleeding occur of said tissue(s) or organ(s), the method comprising inserting a device according to any of the preceding items into a patient.

Claims

1. A device for providing resuscitation or suspended state through redistribution of cardiac output in a human being, the device comprising

- a elongated body extending between a proximal end and a distal end, the distal end being insertable into the mouth, pharynx, and esophagus of the patient,

- wherein said distal end is configured with a diameter that is smaller than the diameter of the widest part of the elongated body,

- wherein the elongated body is made from or encloses one or more high-density weighted element(s) that are movable radially relative to a line formed between a centre of the proximal end and a centre of the distal end of the elongated body, and

- wherein said high-density weighted element(s) has/have a weight sufficient to be able to deflect the esophagus by applying gravitation-derived pressure against the dorsally facing surface of the esophagus when the device is introduced into the esophagus of a human subject placed on its back, and thereby provide redistribution of the cardiac output upon interaction between the esophagus and aorta.

2. The device according to claim 1, wherein said high-density weighted element(s) comprise at least partially one or more metals and/or alloys selected from the group consisting of: Tungsten, platinum, gold, silver, rhenium, iridium, osmium, palladium, bismuth, steel, cobalt, gadolinium, tantalum, niobium, molybdenum, hafnium, zirconium, neodymium, chromium, nitinol, iron and/or steel.

3. The device according to claim 1 or 2, wherein said high-density weighted element(s) are configured to be insertable into the esophagus with a diameter up to 45 mm.

4. The device according to any of the preceding claims, wherein the high-density weighted element(s) are at least partially configured with a density that is higher than at least partially the remainder of the device.

5. The device according to any of the preceding claims, wherein the proximal end is configured with a securement mechanism to prevent displacement of the proximal end through the mouth of the patient, said securement mechanism optionally comprising of or is attachable to at least one or more of the following : a handle, a stop block, a bite block, a string, a guidewire, a tubing, a catheter, an adhesive, a mask, a mouthpiece, a strap, a harness, an airway device, including supraglottic airway devices, an endotracheal tube, the patient's skin, teeth, tongue, bed, gurney and/or stretcher.

6. The device according to any of the preceding claims, wherein said high-density weighted element(s) are positioned inside or onto the elongated body of the device or comprises the elongated body and/or the proximal end and/or distal end of the device.

7. The device according to any of the preceding claims, wherein said high-density weighted elements are configured with an at least partially rounded or atraumatic or shape, coating or covering in the surface facing towards the esophagus when inserted into or positioned against the esophagus in the caudal direction of the esophagus and/or configured with an at least partially rounded or atraumatic shape, coating or covering in the surface facing towards the esophagus when removed from or positioned against the esophagus in the cranial direction of the esophagus.

8. The device according to any of the preceding claims, wherein at least two or more of the high-density weighted elements are positioned around, adjacent to or enclosed by interspaced member(s).

9. The device according to claim 8, wherein said interspaced member(s) are at least partially comprised of at least one material of lesser density and/or higher mechanical flexibility and/or material flexibility and/or higher elasticity than said high-density weighted elements.

10. The device according to any of the preceding claims, wherein the proximal end is configured with a smaller diameter and/or circumference than the high-density weighted element(s) to facilitate the delivery of concurrent airway devices through at least one or more of the following : The mouth, nasal cavity, nasopharynx, oropharynx, and/or hypopharynx.

11. The device according to any of the preceding claims, wherein the distal end is configured with an at least partially rounded or atraumatic or flexible shape, coating or covering in the surface facing towards the esophagus when inserted into or positioned against the esophagus in the caudal direction of the esophagus and/or configured with an at least partially rounded or atraumatic shape or flexible shape, coating or covering in the surface facing towards the esophagus when removed from or positioned against the esophagus in the cranial direction of the esophagus.

12. The device according to any of the preceding claims, wherein at least part of the shape of the device is configured to follow a pre-formed curve and/or bend, and/or wherein at least part of the device is configured with a mechanical flexibility to conform to the shape of the patient's mouth, pharynx and/or esophagus.

13. The device according to any of the preceding claims, wherein the distal end of the device is comprised of the most distal part of the most distal high-density weighted element and/or the proximal end of the is comprised of the most proximal part of the most proximal high- density weighted element.

14. The device according to any of the preceding claims, which comprises at least two of said high-density weighted elements, which are positioned consecutively and engaging one and one in at least one joint.

15. The device according to any of the preceding claims, wherein the elongated body is flexible so as to allow the one or more weighted elements to descent under the influence of gravitational force when placing the elongated body along a horizontal axis.

16. The device according to any one of the preceding claims wherein the one or more weighted elements are arranged in the elongate body over at least a length of 10 cm.

17. A method for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient, the method comprising : -providing an elongated body extending between a proximal end and a distal end

- inserting at least the distal end into esophagus of the patient via the mouth of the patent,

- arranging the patient in a position such that the weight of the elongated body bends the esophagus to an extend where the esophagus presses against the aorta and at least partially collapses the lumen of the aorta to at least partially redistribute flow and increase supply to the brain and heart for the patient.