Patent Description:
Thermally-controlled collars used on patients with severe trauma are known, both for immobilizing or limiting the movements of the head with respect to the spine, as well as for performing a heat treatment of the neck's circulatory system that supplies blood to the brain. An example of a thermally-controlled collar known in the state of the art is described in the international patent application <CIT> by the same Applicant.

Generally, such collars have a rigid or semi-rigid annular support body able to wrap and immobilize the patient's neck. Such collars comprise a plurality of refrigeration elements for absorbing/supplying heat from/to the patient's neck.

Known solutions provide that such refrigeration elements are integrated into the body of the collar in an irremovable manner, presenting the coldest surface in direct or indirect contact with the patient's neck so as to regulate its temperature in a controlled manner.

The refrigeration elements known in the state of the art can comprise duly cooled Peltier cells which are managed by means of a control unit. It is evident that the refrigeration elements of this type are very complex, expensive and difficult to manage.

Furthermore, the thermally-controlled collars are generally of the disposable type, because it is necessary to guarantee a high degree of sanitation before the collar is applied to the patient in order to prevent infections. Therefore, it is provided that a new collar is applied with each use, and that the one already used is disposed of without recovering any component. This entails high management costs, mainly due to the cost of the refrigeration elements.

In addition to this, it is necessary to completely change the collar also in the event of failure or malfunction of the refrigeration elements, because it is not possible to act in a targeted manner only on the broken or malfunctioning component.

Other known solutions provide that the refrigeration elements are of the type that can be "recharged" after a certain period of time, after which they have exhausted their cooling effect. The refrigeration elements are pre-emptively located and stored in a refrigeration unit that has to always be transported or positioned in proximity to the patient.

One disadvantage of these collars is that the replacement of the refrigeration elements during use is particularly complex and can be uncomfortable and painful for the patient. Furthermore, if the replacement of the refrigeration elements does not occur in the correct way and at the correct time, the temperature regulation therapy adopted to that point can be nullified. Furthermore, the replacement at cyclical time intervals requires the constant presence of a trained healthcare professional who supervises and monitors the patient and the operating status of the collar.

Another disadvantage that is encountered in known thermally controlled collars is that the body of the collar is particularly rigid because it has to integrate and/or support the refrigeration elements. This causes inconvenience in applying the collar to the patient's neck as well as a consequent difficulty in removing it.

<CIT>, <CIT>, <CIT> and <CIT> are all also considered relevant prior art.

One purpose of the invention is to improve the state of the art.

Another purpose of the invention is to provide a thermally controlled collar which has much lower production and management costs than those of the state of the art.

Another purpose of the invention is to provide a collar that allows to cool and/or heat the structure that wraps a patient's neck in an extremely rapid, uniform, targeted and controlled manner.

According to one aspect of the invention, a thermally controlled collar is provided in accordance with the characteristics of claim <NUM>.

Other characteristics and advantages of the present invention will become more apparent from the detailed description of some preferred but not exclusive embodiments of a thermally controlled collar, shown as a non-limiting example in the attached drawings wherein:.

With reference to <FIG>, a thermally controlled collar, hereafter also just collar, <NUM> intended to be worn around the neck N of a patient P, comprises a flexible body <NUM> that has, in a wrapped configuration, an overall annular shape.

The flexible body <NUM> can advantageously be of the single use type, that is, disposable, but in other embodiments it can be of the reusable type.

The collar <NUM> can advantageously be wrapped around the neck N of a person who has suffered a traumatic event, such as a road accident for example, or other clinical condition in which there is a need to regulate the cerebral temperature, but it can also be advantageously used in a sports context. For example, the collar <NUM> can be wrapped around the neck N of a pilot in motor racing or sports racing competitions, in which the person is destined to endure very high temperatures for several hours.

The collar <NUM> also comprises temperature control means <NUM> associated with an external wall <NUM> of the flexible body <NUM> in a removable manner, and a control unit <NUM> configured to manage the temperature control means <NUM>.

Here and hereafter in the description, by external wall <NUM> we meant the wall of the flexible body <NUM> opposite an internal wall <NUM> which, during use, is disposed in direct contact with the neck N of the patient P.

In other words, according to the invention the flexible body <NUM> is interposed between a heat exchange surface of the temperature control means <NUM> and the neck N of the patient P, acting, as will become clearer in the following, as an interface for the absorption/emission of heat.

The flexible body <NUM> comprises one or more bags that have a shape and size such as to wrap the structures the temperature of which is to be controlled, in this specific case the surface of the neck N.

In the example given here, the flexible body <NUM> comprises two bags, indicated with reference numbers 17a and 17b.

The bags 17a, 17b are advantageously made of biocompatible material, such as PTU ether or other similar or comparable materials.

The bags 17a, 17b can have the shape of a band. Each bag 17a, 17b can, for example, have, as standard sizes, a height equal to approximately the axial extension of the neck N of the patient P and a length equal to approximately half the circumference of the neck N of the patient P.

Each bag 17a, 17b can be selectively filled with a conductive liquid L. The temperature of the liquid L is regulated by conduction by means of the temperature control means <NUM>.

Each bag 17a, 17b is provided with a duct <NUM> and a valve <NUM> through which each bag 17a, 17b can be filled with the desired quantity of liquid L. Specifically, an aperture (not shown) is made on each bag 17a, 17b, which is suitable to receive one end of the duct <NUM>. Preferably, the connection between the duct <NUM> and the aperture produces a sealed coupling, and it can comprise a threaded mechanical connection, or a pressure connection. Depending on the volume of liquid introduced into the bags 17a, 17b, their stiffness is determined, which can be chosen as a function of the specific condition of the patient P or the type of therapy to be performed. For example, the collar <NUM> can be initially applied to the neck N of the patient P with the bags 17a, 17b empty, and they can be filled immediately afterward in the desired manner.

The valve <NUM> can be of the one-way, or non-return, or two-way type, so as to allow to empty the bags 17a, 17b before eliminating them at the end of the treatment.

The bags 17a, 17b can have section widenings, or convex zones <NUM>, which, during use, are disposed in correspondence with the blood vessels to be reached in such a way as to increase the contact surface with the neck N and improve the heat exchange efficiency of the collar <NUM>. During use, two of such convex zones <NUM> are disposed in the lateral-frontal position of the neck N, while the other two are disposed in the lateral-posterior position.

As can be seen in <FIG>, each bag 17a, 17b comprises two convex zones <NUM>, disposed at opposite ends of the bag, separated by a central portion <NUM>. The height of the convex zones <NUM> is greater than the height of the central zone <NUM>.

The duct <NUM> enters the respective bag 17a, 17b in correspondence with one of the two convex zones <NUM>.

The bags 17a, 17b can be provided with internal welds or channels which have the purpose of directing the liquid L from and toward the convex zones <NUM> as a result of the heat exchange with the neck N.

The shape of the bags 17a, 17b is such as to minimize the pressure on the neck, so as not to compress the underlying blood vessels in a clinically significant manner. If this compression were to occur, it could potentially cause serious harm to the patient, with the risk of nullifying the therapeutic benefits obtained with the temperature management.

The flexible body <NUM> is provided on the external wall <NUM> with quick coupling means <NUM> on which a support structure <NUM> for the temporary support of the temperature control means <NUM> couples in a removable manner.

In particular, the bags 17a, 17b are provided, on their respective external wall <NUM>, with buttons 22a and slots 22b on which the support structure <NUM> is coupled. In this specific case, the slots 22b are made in a single body with the bags 17a, 17b, but they could be produced in many different ways.

The support structure <NUM> can comprise a strap <NUM> which wraps the bags 17a, 17b externally, connecting them to each other.

The strap <NUM> is attached to the bags 17a, 17b in a removable manner, by means of the buttons 22a and the slots 22b inside which it is made to pass. After the collar <NUM> has been used, the strap <NUM> can be released and removed so that it can be reused, or it can be of the disposable type, like the flexible body <NUM>, and eliminated together with it once the collar <NUM> is no longer used.

The strap <NUM> is made of a flexible but non-extensible material, such as PVC for example, or other similar or comparable materials.

Along its development, the strap <NUM> is provided with closure devices <NUM> and with possible adjustment devices <NUM> for adjusting the size of the collar <NUM>, which is determined directly on the neck N of the patient P.

In a closed configuration of the collar <NUM>, the closure devices <NUM> can be positioned at the front while the adjustment devices <NUM> can be placed at the rear.

In the example described here, the closure devices <NUM> are configured as a tear strip, preferably elastic, while the adjustment devices <NUM> are configured as an elastic band or ring.

The temperature control means <NUM> can comprise at least two temperature control units 13a, 13b, hereafter also refrigeration and/or heating units, each of which consists of the combination of a thermoelectric module, in this specific case a Peltier cell <NUM>, and an exchanger module, in this specific case a liquid exchanger <NUM>, functional to keep the Peltier cell <NUM> efficient.

As is known, the Peltier cell <NUM> has two heat exchange surfaces 28a, 28b (<FIG>), namely a first surface 28a, which during use faces the underlying bag 17a, 17b, and a second surface 28b, opposite and parallel to the first surface 28a, which is in direct or indirect contact with the liquid exchanger <NUM>. By suitably managing the current that passes through the Peltier cell <NUM>, it is possible to control the temperatures of the first and second surfaces 28a, 28b.

Preferably, the first surface 28a which comes into contact with the bag 17a, 17b has a conductivity of at least <NUM> W/m K, while the other surfaces have a conductivity of about <NUM> W/m K.

In the example described here, there are two refrigeration and/or heating units 13a, 13b, each of which can reach, independently of each other, a temperature comprised in a range between about <NUM> and about <NUM>.

The presence of two refrigeration and/or heating units 13a, 13b combined with the flexible body <NUM> filled with the liquid L makes the heat exchange very effective and reduces the complexity and cost of manufacturing the collar <NUM> compared to those of the state of the art.

The refrigeration and/or heating unit 13a, 13b is preferably positioned along the strap <NUM> so as to be disposed on the respective bag 17a, 17b in correspondence with the central portion <NUM>. In this way, during use, the refrigeration and/or heating units 13a, 13b are disposed in a lateral position on the neck N of the patient P, where the curvature of the latter is less pronounced, thus being able to guarantee a more extensive contact and therefore a more effective regulation of the heat, while reducing the pressure on the neck. A pressure higher than 20cmH<NUM>O on the neck, in fact, can be an obstacle to the venous return of blood from the brain, causing potentially even very severe damage to the patient.

The refrigeration and/or heating unit 13a, 13b comprises a shell <NUM> which contains the Peltier cell <NUM> and the liquid exchanger <NUM>.

The shell <NUM>, which can for example be made in two parts, is provided with releasable coupling means <NUM> for the temporary connection with the strap <NUM> or directly with the bags 17a, 17b.

The releasable coupling means <NUM> can, by way of example, comprise at least one through element <NUM>, preferably two, as in the example described in <FIG>.

Alternatively, the releasable coupling means <NUM> can comprise magnetic or ferromagnetic elements able to couple to corresponding ferromagnetic or magnetic elements.

By way of example, the magnetic elements can be configured as magnets. In one embodiment, three magnetic elements can be provided applied directly on each of the bags 17a, 17b, each of them cooperating with a respective magnetic element disposed in a correlated position on each refrigeration and/or heating unit. The distribution of the magnetic elements is uniform, so as to guarantee a firm connection between the bag 17a, 17b and the corresponding refrigeration and/or heating unit 13a, 13b.

Other types of releasable coupling means <NUM> can comprise coupling means of the mechanical type, for example sliding, interlocking, or pressure coupling means.

The refrigeration and/or heating unit 13a, 13b is provided with temperature detection sensors <NUM>, of which at least one, preferably at least two, is disposed on the first surface 28a which, during use, comes into contact with the bag, and at least one on the liquid exchanger <NUM>, in order to monitor the efficiency of the heat removal.

The detection sensors <NUM> are operatively connected to the control unit <NUM>, which can manage the refrigeration and/or heating units 13a, 13b both on the basis of the user's indications and also on the basis of the signals received from the detection sensors <NUM>. The control unit <NUM> allows to manage both the desired temperature value for each refrigeration and/or heating unit 13a, 13b, and also the temperature variation ramp.

The control unit <NUM> comprises pumping and dissipation means <NUM> configured to make a heat exchange liquid circulate inside the liquid exchangers <NUM> of the refrigeration and/or heating units 13a, 13b, advantageously managing them in an independent manner.

The control unit <NUM> is configured to dissipate at least 400W of heat.

The control unit <NUM> also comprises storage means <NUM> where all the operating data of the collar <NUM> and the alarms that have arisen are recorded, and where standardized programs for managing specific traumas or pathologies can be preloaded.

The control unit <NUM> can be powered both with an electric network and also, alternatively, with batteries so that it can also function during transport, making the collar <NUM> functional for any application whatsoever.

As stated, each refrigeration and/or heating unit 13a, 13b can be managed individually by the control unit <NUM> and receive a dedicated flow of heat exchange liquid by means of a three-lumen tube <NUM> specifically designed to minimize the loss of efficiency.

In practice it has been verified that the invention achieves the intended purposes.

The invention as conceived is susceptible to modifications and variants, all of which are within the scope of the inventive concept.

Furthermore, all the details can be replaced with other technically equivalent elements.

Claim 1:
Thermally controlled collar (<NUM>) designed to surround the neck (N) of a user (P) and comprising a flexible body (<NUM>), of the disposable or reusable type, configured to be filled with a thermally conductive liquid (L), which in a wrapped configuration has an annular shape and contacts said neck (N), said collar is characterized in that it comprises temperature control means (<NUM>) for controlling the temperature of said liquid (L), of the reusable type, associated with an external wall (<NUM>) of said flexible body (<NUM>) in a removable manner so that the flexible body (<NUM>) is interposed between a heat exchange surface of the temperature control means (<NUM>) and the neck (N) of the user (P) and said temperature control means (<NUM>) are connected to a control unit (<NUM>) configured to control the thermoregulation of said liquid (L), and in that it comprises a duct (<NUM>) and a valve (<NUM>) through which a desired quantity of liquid (L) can be inserted into said flexible body (<NUM>) in order to adjust its stiffness.