WO2014076615A2

WO2014076615A2 - Device for protecting vascular catheters

Info

Publication number: WO2014076615A2
Application number: PCT/IB2013/059974
Authority: WO
Inventors: Mariano VICCHIO; Alessandra AMATO
Original assignee: Vicchio Mariano; Amato Alessandra
Priority date: 2012-11-13
Filing date: 2013-11-07
Publication date: 2014-05-22
Also published as: ITRM20120553A1; WO2014076615A3

Abstract

Device(1; 100; 110) for protecting vascular catheters(20), bearing a system with inviolable closure(14, 15) for preventing the improper use of the catheter. The inviolable closure system has weakening lines or notches(28, 28', 28") for its irreversible breakage and an access(29) for a tool or another breakage means(27). Also preferably provided is a sleeve (11) for introducing an antiseptic and a resilient hinge (8).

Description

"Device for protecting vascular catheters"

Description Field of the art

The present invention generally refers to the field of medical devices, and more particularly to a device for preventing or in any case considerably reducing the probability of infections for sick people subjected to treatments in hospitals or other places. Specifically, the invention regards a device for protecting a vascular catheter, capable of reducing the possibility of contaminations or even maintaining an aseptic environment at the ends of the catheter. More specifically, the invention regards the structure of a box for protecting a vascular catheter that reduces bacterial contaminations due to the exposure of one or more portions of the vascular catheter to the outside environment. Prior art

Vascular catheters are medical aids of widespread use in daily clinical practice. Vascular catheters are divided into two different types: central vascular catheters and peripheral vascular catheters. The central vascular catheters are characterized in that they are inserted in a large vein of the organism, said central vein (internal or external jugular, subclavian, femoral). The peripheral vascular catheters are instead inserted in a smaller vein, and are named as such since the implant site is usually in a peripheral location and in surface veins (arm or hand veins). The central vascular catheters have the advantage of introducing drugs directly into the heart or in large venous vessels, a necessary condition for the administration of drugs of complex medical management, such as inotropic drugs. In addition, they can allow the administration of hyperosmotic substances such as parenteral nutrition mixtures. The use of the central vascular catheters, although necessary, is complicated by a high rate of infections which make this medical aid type hard to manage; such infections are correlated with a high morbidity and mortality rate. A special category of central vascular catheters is represented by the dialysis catheters, whose object is to make possible the dialysis in patients lacking arteriovenous fistula. These are large-size vascular catheters, with at least two external ends, one which allows the blood to arrive at the filter for the dialysis, and another which allows the filtered blood to return to the venous circulation of the patient.

The peripheral vascular catheters instead have the advantage of a lower rate of infective disease complications, so that they are quite suitable for the frequent handling of daily treatments, even if they are not capable of allowing administrations of hypertonic substances or inotropic drugs. These small-size catheters can also be useful for drawing blood for diagnostic purposes. The international guidelines on the correct management of the central vascular catheters recommend a careful, and when possible, rare handling of the external ends of the catheters in order to reduce the bacterial contamination thereof. Hospital workers must comply with a series of regulations in the management of such medical aids, all aimed for preserving the duration of the aids and for reducing the risk of infection of the patient. Scientific studies show a close correlation between the increase of the rate of infection in patients bearing central catheters, and the increase of the number of daily administrations of drugs through the same catheters. From these considerations, there arises the need, recognized by international studies, to use the central vascular catheters only when necessary, hence for the administration of inotropic drugs or substances with high osmolarity, leaving all other uses to the peripheral catheters (common drugs and blood drawing for diagnostic use). Therefore, it would be extremely useful to provide a device which prevents the erroneous access, of hospital workers, to the central vascular catheters for functions not indicated for the use thereof, thus preventing the administration of common drugs in such catheters, or simple blood drawing, so that the use of the peripheral vascular catheter is instead provided. Indeed, in standard treatment conditions for hospitalized conditions, a peripheral vascular catheter is always present for the administration of drugs. Associated with this type of venous access, it is possible that a central vascular catheter is also present for the above-described treatment uses (dialysis, inotropic drugs). Therefore, one must absolutely prevent the hospital worker from administrating routine drugs in the central venous catheter, rendering the latter for example temporarily inaccessible by means of a suitable protection device, which preferably also maintains an aseptic environment for the portions of the catheter that are potentially more exposed/sensitive to infections. Up to now, however, devices do not exist which solve all of these problems. The administration of simple drugs in the central venous catheter can occur due to the distraction of the hospital worker or due to the easier administration in these catheters with respect to peripheral ones. In fact, the latter have reduced size, with a rigid administration line anchored to the arm or to the hand by means of a few millimeters of immobile duct. The central vascular catheters instead have one or more external ends for the infusion of the drugs with length variable from 5 to 8 centimeters, which are flexible, movable and have greater diameter. They can therefore be more easily handled for drug injection operations or for drawing blood samples. Such operation increases the risk of infection of the patient, and it should be avoided. With regard to the dialysis catheters, there are further considerations to keep in mind. The dialysis is carried out in dedicated structures, in which there are specialized personnel and facilities/aids. For the purpose of the dialysis, the paramedical personnel wash and fill the catheter with anticoagulant solutions, in order to leave the catheter for dialysis pervious for 48 hours, the time intervening until the next use of the catheter for the new dialytic treatment. During this 48 hour interval, the patient stays in in-patient departments that are different from that of dialysis. In such departments, the paramedical personnel, acting contrary to the international guidelines and medical regulations diffused by all head physicians or hospital management, often use the dialysis catheter for conventional treatments and for drawing blood. After such actions, such personnel do not wash the catheter and fill with anticoagulants, due to inexperience in such practices and due to the lack of the solutions provided only for dialysis. This causes a high rate of coagulation of the catheter. Such coagulation ensures that when the patient returns for the new dialytic treatment, which is usually once every three weeks, the catheter does not function. This requires the removal of the catheter with the implanting of a new one, with increase of costs, time of the medical personnel, and patient risks, given that the implantation of a new catheter is very invasive. As already stated above, in the international scientific studies on the causes of infection of the central vascular catheters, it is clearly reported that the percentage of infection increases with the increase of use, and thus with the increase of the administrations of drugs through the external ends of the catheters. This is based the fact that the administration of a drug requires the opening of the closure cap of the vascular catheter and the handling of the external ends. The higher the number of daily repetitions of such procedure, the greater the rate of infection of the catheter and thus of infection of the patient. The international guidelines provide that, for a correct management of the central vascular catheters, such aids are only used when strictly necessary (dialysis, inotropic or vasoactive drugs, parenteral solutions), leaving to the small peripheral vascular catheters the administration of other drugs that do not require the administration in a large-size vein. Even if the problem is quite significant in the international scientific world, up to now no medical aid has been described that is capable of protecting vascular catheters from improper use. Therefore, one object of the present invention is to provide a protection case that is not openable except by breakage of the complex closure system. This requires the actual will to access the catheter, preventing a use of the catheter caused by distraction or by the greater ease of handling with respect to a peripheral catheter. In addition, in such a manner it is prevented that, due to an erroneous choice of the operator, the operator administering the drug prefers the central catheter instead of searching for a peripheral vein, should the peripheral catheter be lacking. Finding the peripheral vein sometimes requires time and even experience, which not all paramedical operators have. Currently, a catheter protection is known from the patent application WO2011/028898. The catheter protection of said patent application WO2011/028898 is constituted by two portions, an upper and a lower portion, capable of being coupled together and creating a closed environment around the dialysis catheter. Nevertheless, such catheter protection of known type has disadvantages. A first disadvantage is given by a high risk of infection for the patient, since the described device is provided with a reversible opening and closing system for the two constituent portions. Such document does not actually describe any irreversible closure system of the box/device for protecting the ends of the catheter. In consideration of the fact that the device of WO2011/028898 has as object the protection of the vascular catheter contained therein, a reversible opening and closing system is not however able to prevent the accidental openings of the device by the patient himself or by hospital workers. Such accidental openings cause the entrance of bacteria in the device, such bacteria commonly present on the patient's skin. In addition, due to the reversible opening and closing, the paramedical personnel might attempt to restore the original closed state of the device after having improperly used the catheter, thus to try to pass the device off as one that has not yet actually been "violated". Indeed, a considerable disadvantage of the device described in WO2011/028898 is given by the fact that such device of the prior art does not protect the dialysis catheter from such coagulation risk, and does not represent a deterrent for the improper uses of the catheter. The international guidelines on the correct use of the catheters for dialysis, compiled by international experts on the matter, clearly report the fact that dialysis catheters must only be used for subjecting the patient to dialysis. Strongly prohibited, therefore, are improper uses such as the administration of drugs or taking blood samples. But considering that the catheters for dialysis represent an easy access to the venous circulation of a sick person, the paramedical personnel, acting against the international guidelines, commonly use the catheters for dialysis for common intravenous treatments or for drawing blood for diagnostic use. Such improper and frequent handling of the catheter for dialysis increases the risk of infectious diseases, but also increases the risk of coagulation of the catheter. Indeed, at the end of the dialysis, the vascular catheter is filled with anticoagulant solution, which only the structures set to conduct dialysis have. The paramedical personnel of in-patient structures, lacking such aids, after having used the catheter for dialysis for improper uses cannot carry out the washing with anticoagulants. The coagulation of the catheter obliges the substitution of the catheter in order to carry out the dialysis with increase of costs and increase of patient risk, given that the insertion of a new catheter is an invasive maneuver. A further disadvantage of the known device is given by the fact that such device described in WO2011/028898 must be associated with a bag of antiseptic liquid that is broken by means of pressure exerted on the box/device. Hence, the device contains antiseptic liquid, but it is widely reported in the medical literature that the continuous use of antiseptics selects increasingly aggressive bacteria. In addition, the presence of an antiseptic liquid inside of the device determines the necessary creation of a protection casing with watertight seal, a characteristic that increases the production costs thereof. In addition, during transportation or storage, the casing could be broken due to external forces acting on the wall of the device. It would therefore be opportune, or highly advisable, to make a device (for protecting catheters from improper use) which does not necessarily provide for the use of antiseptics in the protection device, in a manner so as to avoid, at least in a more economical achievement of the device, costly expedients (cases, gaskets, etc.) for obtaining a watertight seal - even with long duration - effective also during device transportation or storage. In general, the object of the present invention is to overcome said disadvantages by providing a protection device for a vascular catheter for dialysis and other applications, which, once closed around the connectors of the ends of the catheter, can no longer be opened, in a manner such to avoid the accidental opening of the device, by the patient as well. More specifically, object of the present invention is to provide protection device provided with a safety closure system that prevents nurse personnel from improperly using the dialysis catheters for purposes different from dialysis itself. In addition, one object is also to indicate to the responsible doctor of the hospital department, or generally to the doctor in charge of the patient's treatment, if someone has deliberately manipulated the catheter in an improper manner, by opening the safety/protection device that is the object of the present invention. A further object of the present invention is to provide a system for protecting a vascular catheter for dialysis during the hours in which the dialysis catheter is connected to the lines that transport the blood to the dialysis machine. In the scientific literature, it is widely demonstrated that the connection zone between the catheter and dialysis lines is more greatly affected by the passage of bacteria from the outside to the blood, and thus the protection of this connection zone has the object of reducing infections correlated with the use of vascular catheters. The device of the present invention, in a particular embodiment thereof, is also able to enclose this connection zone during the time of dialysis and the innovative inviolable closure system prevents any accidental opening. Description of the invention

The objects of the present invention are obtained by means of a device or box for protecting a vascular catheter having an "inviolable" closure system. Such protection device reduces the bacterial contaminations due to the exposure of one or more portions of the vascular catheter to the outside environment. By "inviolable" it is intended, in the present context, that the opening and closing process is not reversible, i.e. that the closure system of the device is irreversibly broken, or is irreversibly compromised, if the device is opened, so that it will no longer be possible to restore its initial state. The possible tampering/opening of the device must therefore be intentional and will then be evident to the eyes of any (possibly attentive) observer of such device, since at least one part of the closure system will be irreversibly compromised. The inviolable closure is capable of preventing the accidental opening (e.g. by the patient), but above all the improper use of the vascular catheters, especially those of dialysis, in order to further reduce the risk of infection, and reduce the risk of "coagulation of the catheters" themselves, where by "coagulation of the catheter" it is intended the obstruction of the lines of the catheter by coagulated blood, as a consequence of the improper removal (in blood circulation of the patient) of the anticoagulant usually previously introduced in the catheter at the end of the dialysis for protective reasons. Indeed, if the dialysis catheter is used improperly at the end of the dialysis, e.g. in another division of the hospital, for injecting a drug, the anticoagulant will enter the veins of the patient under the thrust of the injected drug, and if another anticoagulant is not substituted or added into the catheter (see above), the catheter could be obstructed, requiring the replacement thereof. The invention has as main object the protection of the catheters for dialysis (and generally of the central vascular catheters) from improper use, in order to prevent the use of the catheter when not strictly necessary for its use functions. In a particular manner, the device protects the dialysis catheters from improper use, such as the administration of drugs or drawing blood for diagnostic purposes, during the time in which catheter is not employed in the dialytic treatment cycle. In such a manner the correct administration is determined by the hospital worker of common drugs by means of the peripheral vascular catheter, with which all hospitalized patients are normally provided, or in the absence of the latter, by finding a peripheral vein and carrying out an intravenous injection in the latter.

Although the present invention mainly regards a device provided with a completely "inviolable" system, in a particular embodiment of the invention the device can be only partially "inviolable". Such case involves the protection of catheters for drug infusion from bacteria, in which the "inviolable part" of the device ensures an indissoluble anchorage of the catheter to the protection device, so that it is impossible to disconnect (if not intentionally) the catheter from the protection device, while the "violable part" has a reversible closing/opening, so as to allow the administration of drugs by opening the respective portion with reversible closure of the protection device. Once the drug is administered through the respective end of the catheter, one can completely reclose the device for protecting the catheter, reclosing the "violable part" (with reversible closure) of the device, and the latter will thus ensure the protection from bacteria due to its walls which act as a physical barrier against external contamination. Also this particular embodiment of the invention is distinguished from the embodiments of the prior art, since it has an "inviolable part" that prevents the accidental separation of the protection box of the catheter from the catheter itself, while allowing an access (by specialized hospital personnel) to the connectors of the catheters for the introduction of drugs. Such solution/embodiment of the invention, of only partially inviolable type, will not be used for dialysis, for which it is more suitable to use a completely inviolable system, in which one can also introduce antiseptics from the outside through a small opening (hole), if present, closable by a cap or by an isolating/sealing material or the like. According to the present invention, such hole reclosable by a cap or a sealant, used for the introduction of antiseptics, unlike the solution employed in the abovementioned patent application, WO2011/028898, ensures that the antiseptic is not accidentally released inside the device during transportation or the like, but rather it is injected into the protection device "in real time", immediately (or nearly immediately) after the closure of the inviolable protection device around the ends of the catheter. The invention is hence mainly characterized by an inviolable closure system acting on at least one portion of the box/device of the invention. Such closure system could for example consist, according to a particular non-limiting or non-binding variant of the invention, of harpoon-like hooks engageable with tabs/bridges, the hooks being integral with an "upper" shell/component of the protection device/box and the tabs or bridges being instead integral with a "lower" half-shell/component of the protection device/box. Evidently the terms "upper" and "lower" are relative, since they depend on the orientation of the box, and one could also speak of "first" and "second" half-shell or component of the protection device. The hooks and/or the tabs (bridges) will have weakening points (predetermined breakage points) which can only be broken intentionally, as illustrated in detail hereinbelow (see "preferred embodiments of the invention"), e.g. by means of a lever movement exerted with any one surgical instrument, such as a small forceps, klemmer or a common needle carrier. The intentional breakage of the tabs must only occur when the doctor responsible for the patient's treatment decides to open and remove the device from the catheter, for any reason, e.g. for its substitution, for an urgent operation, or (e.g. in the case of catheter for dialysis) when the patient returns to the dialysis department for a new dialytic cycle. In this case, it will be decided whether to apply on the catheter the completely inviolable variant of the device of the invention, which ensures the protection of the ends of the catheter from bacteria contaminations and improper access even during dialysis. Possibly, an antiseptic can also be introduced into the device, through the abovementioned hole, which will then be closed or sealed.

The protection device or box can be obtained in a manner such that its half-shells (upper and lower) are only connected to each other by means of the inviolable closure means. As specified above, in another variant of the invention, a part of the closure means can also be reversible/violable. In another variant of the invention, the two half-shells are also connected to each other by at least one hinge, placed on the opposite side of the device with respect to the inviolable closure means (see the following detailed description of the preferred embodiments of the invention). Preferably the hinge will have a certain resilience, or elastic memory, returning towards a condition that maintains the protection box partially open when the inviolable closure means have been tampered with (i.e. broken) or if the box is not correctly closed. This allows the responsible doctor to immediately notice the state of the protection device. In addition, if the device has been tampered with, by breaking the aforesaid tabs, and/or the harpoon-like hooks, these will project from the protection box to an extent such to make such tampering evident. Other inviolable systems can of course be conceived by the man skilled in the art for attaining the same object without departing from the protective scope of the invention.

Preferably the protection box is made of plastic material. Preferably it is obtained (together with the possible hinge that connects the half-shells) by injection molding of plastic material. Preferably the half-shells are symmetric (identical size). Any number of holes for introducing the antiseptic can be provided, equal to one or even greater than one, on the same side or even on different sides of the device. Preferably the device has the shape of a parallelepiped with two half-shells (upper and lower) substantially mirroring each other. Of course, the protection box constituting the protection device for catheters according to the present invention will also have (as in the abovementioned document WO2011/028898) a number of holes "corresponding" to the number of ends of the catheter that one intends to protect. The adjective "corresponding" can for example indicate a number of holes equal to 2N or N, N being the number of ends of the catheter. For example, in the case of a catheter for dialysis, having two ends (N = 2), respectively corresponding to the afferent and to the deferent lines, the device of the invention can have 4 holes or 2 holes, depending on whether the device is used only during dialysis or only between the two dialysis cycles. This is fully described in the abovementioned document as well. Preferably, especially if the device has parallelepiped form, a pair of these holes (for the passage of the two ends of the dialysis catheter) will be provided on one side of the device, while the other pair of holes (for the lines directed towards the dialyzer) will be provided on the opposite side of the parallelepiped. This in order to prevent useless bending of the lines/ducts in which the blood passes. Moreover, especially if the half-shells of the device are not symmetric, said passage holes or the lines or ducts (small flexible tubes), including those for the passage of the ends of the catheter, could be entirely made in a half-shell (in the larger half-shell), in the form of through holes, and in this case the ends of the catheter and the dialysis lines will have to be separately "inserted" in the respective holes. Nevertheless, preferably, each passage hole will be obtained in part in one half-shell and in part in the other half-shell, in the form of semicircular notches obtained on the edge of the half-shells in coinciding positions, in order to complete themselves, forming a circular hole when the device is closed. This solution, already per se known, allows setting the respective end of the catheter in a circular notch of a first half-shell and locking it inside the protection device (by means of the opposite notch) when the other half-shell is closed on top of the first half-shell. This system is extremely practical and quick, since it will suffice to set the ends of the catheter, or those of the dialysis lines or the like in the respective semi-circular notches of the "lower" half-shell, and then close the "upper" half-shell in a snap-like manner on the "lower" half-shell in order to suitably protect from contamination that part of the catheter and/or of the "external" lines that are at risk of contamination (lines towards the dialyzer or other).

Hence, preferably, the inviolable closure system will also be a quick closure system. A particular implementation of a quick closure system is that already described above, in which the harpoon-like hooks are inserted in bridge-like tabs, and once snap-inserted it is impossible to extract them again from the interspace formed by the bridge, except by breaking the latter. This "inviolable" system is not the only one possible. Any other irreversible system can be employed according to the present invention. In addition, as already stated, it is preferable that the inviolable closure system be obtained in a manner such that a tampering thereof can be immediately recognized, in order to be able to take the necessary counter-measures. In particular, said tabs, after having been broken, inevitably project from the body of the box and are easily recognizable. Moreover, preferably, if a connection hinge is used between the half-shells, such hinge will have a certain elastic memory that ensures that the protection box will tend to assume (when the hooks are not inserted in the tabs) an easily-recognizable semi-open position.

Nevertheless, the present invention generally regards the protection devices (for catheters) provided with inviolable closure system, and is not limited to the inviolable quick closure systems and/or to systems which make a probable improper use of the protection box immediately recognizable for any observer.

One particular embodiment of the invention provides for pyramid structures (adapters) for adapting the device of the invention to the variable diameters of the infusion lines or of the catheter itself. This means that by means of the cutting of a portion of the adapter, one can provide a hole of desired diameter, corresponding with that of the available line or duct. This will be better clarified, making reference also to the enclosed drawings, in the detailed description of the preferred embodiments of the invention.

Preferably, the adapter will be composed of two mirrored "semi-pyramids", which complete each other when the box is closed, each semi-pyramid being integral with the edge of a half- shell.

Preferably, the device of the present invention is transparent. This in order to be able to monitor the possible leakage of blood from the connectors of the ends of the catheter.

Preferably the protection device is of inexpensive type, and thus it does not have watertight sealing gaskets in the passage holes of the ends of the catheter and generally passage holes of the ducts, and/or it lacks gaskets along the edges of the half-shells. Nevertheless, the present invention also comprises the case in which the device also comprises watertight sealing means (gaskets, etc.) on the holes and/or along the edges of the half-shells.

The preceding explanations generally illustrate the present inventive concept and several specific concrete embodiments thereof. Nevertheless, the following detailed description of several preferred embodiments serves to further clarify the technical progress obtained with the present invention, and the important practical consequences thereof, both for doctors and hospital patients, with regard to safety. In addition, the following detailed description of several preferred embodiments of the invention, without wishing to limit the protective scope of the invention in any manner, will serve to assist an average man skilled in the art to reproduce the present invention, if he so desires. Together with the preceding discussion, the present inventive concept will therefore be comprehensible.

Of course, the man skilled in the art can easily modify parts of the device, easily attaining equivalent solutions which do not lies outside the present inventive concept. In particular, the present invention is not limited to specific materials and/or to particular device manufacturing processes.

Brief description of the drawings

The drawings show:

FIGURE 1 : a protection device for a vascular catheter with two ends, according to a first embodiment of the present invention, in perspective view and in acute-angle open condition; FIGURE 2: the protection device for a vascular catheter, according to figure 1, but in closed condition;

FIGURE 3: the cross section of the device of figure 1 (in 180° completely open position) executed in a manner so as to illustrate the elements of the inviolable closure system according to one possible embodiment of such system;

FIGURE 4: a section analogous to figure 3, but with the device of the invention in closed condition (as in figure 2);

FIGURE 5: a perspective view of a central catheter for dialysis, having two ends, usable in combination with a protection device according to the invention like that illustrated in the preceding figures;

FIGURE 6: the voluntary, careful action exerted by an opening instrument/tool, on the inviolable closure, in order to open the protection device according to the first embodiment of the invention (like that shown in figures 1 to 4); FIGURE 7: a view analogous to that of figure 1 of a device according to the first embodiment of the invention, but after the irreversible breakage of the inviolable closure system (projecting tongues);

FIGURE 8: the central catheter of figure 5 with the ends positioned inside the device of the invention;

FIGURE 9: a variant of the first embodiment of the invention, in which two further holes for the lines (small flexible tubes or ducts) are also provided, directed towards dialysis equipment (dialyzer);

FIGURE 10: a variant for the inviolable closure, in the protection device of the first embodiment, in which instead of tear-off tabs, the coupling teeth are weakened;

FIGURE 11 : a connector according to the present invention, for variable diameters of the ends of the catheter and of the dialysis lines or drug infusion lines in the case of infusion catheters;

FIGURE 12: a protection device for vascular catheters, according to a second embodiment of the invention, of modular type and with inviolable closure of the third type (one observes the absence of the hinge on the rear side);

FIGURE 13: the device of figure 12 with the two half-portions closed in an inviolable manner;

FIGURE 14: the device of figures 12 and 13 completely closed in an irreversible manner, in which the opening method is underlined;

FIGURE 15: the device of the present invention, in a third possible embodiment thereof with "mixed closure", having a first portion with inviolable closure (shown closed in figure 15) and a second portion with reversible closure (as in the state of the art, shown open in figure 15);

FIGURE 16: shows the third embodiment of the invention, with ends of an infusion catheter inserted in the inviolable part (closed in the figure), while the normal/reversible closure part is in open condition; FIGURE 17: shows the third embodiment of the invention in closed condition (but without the catheter, only for simplifying the drawing).

Detailed description of several preferred embodiments of the invention

The figures show only several possible non-limiting and non-binding embodiments of the invention. The box can have one or more inlet and outlet holes, one or two internal dividers, and a variable number of small external bars for the passage of "laces" for fastening the box/device to the patient. The method of figure 6 is typical for the 3 system models with inviolable closure.

The various figures which show the different embodiments of the invention will now be discussed in succession and in more detail.

The device of the invention 1, or simply the "box" 1, is formed for example by two half- shells , 1" substantially symmetric with regard to their external base form. The two half- shells Γ, 1", essentially rectangular in this embodiment, have an internal space that receives the ends of the catheter and they can have a divider septum 2 for "separating" the two ends of the catheter (see also Fig. 8). Small arch-like bars, 3, integral with the upper half-shell 1 ', serve to fasten the device 1 to the body of the patient by means of suitable means, such as tape, laces or the like. In this embodiment, there are two pairs of semi-circular holes 4 on a first wall 5 while on a second wall 6 such semi-circular holes are absent. When the wall 5 is "complete", i.e. in closed condition of the device 1 (see Fig. 2), also the semi-circular holes 4 complete each other, forming actual circular holes 7 on the wall 5, each adapted to receive the respective end of the catheter (see also Fig. 8 and Fig. 16, even if figure 16 regards another embodiment). The means described up to now are per se already known. The two half-shells can be made of plastic molding material.

In the lateral side of the box 1, indicated in Fig. 1 with the reference number 9, where the half-holes 4 are not present, there is a hinge 8 that connects together the half-shells , 1", respectively upper and lower. The hinge 8 preferably forms a single molding piece with the plastic material of the half-shells, connecting them. According to one particular characteristic of the present invention, said hinge 8 has an elastic memory which tends to open the box 1 towards an opening angle of 45°, for example (as in figure 1), when said box 1 is open, i.e. when the inviolable closure means (which will be described below) do not lock the box 1 in closed condition (as in figure 2).

Unlike the abovementioned prior art, a second lateral side, indicated with the reference number 10 (and opposite the first lateral side 9), for example comprises a sleeve 11 for introducing an antiseptic. In this manner, the antiseptic can be introduced - after the closure of the ends of the catheter in the box 1 - in a quantity desired and metered by the operator. The latter also has the power to introduce or not introduce the antiseptic, at his discretion. Since the antiseptic is introduced in "real time", i.e. it is absent in the box 1 before the use of the same, it is not absolutely necessary to provide for particular gaskets which prevent the outflow thereof during the storage or transport of the box 1. It will for example be sufficient to provide for a perimeter sealing tooth 12 on the lower edge of the upper shell 1 ', inserted, with shells closed, in the perimeter sealing groove 13 (see Fig. 3) provided on the upper edge of the lower shell 1".

According to the present invention, the second lateral side 10 has inviolable closure means (in this specific non-binding embodiment) constituted by tear-off tongues (or bridges) 14 and by coupling teeth (or harpoon-like hooks) 15. The function of such inviolable closure means is clearly illustrated in the figures and specifically in figure 3, the coupling tooth 15 being inserted in the slot 16 created by the tear-off tongue/tab with bridge form 14. The slot 16 has an initially rounded form (see Fig. 3) in order to facilitate the introduction of the tooth 15 in the slot 16, and then it is narrowed. The elasticity of the plastic material allows the deformation of the slot, i.e. of the tab, after which the harpoon-like hook 15 remains locked in an irreversible manner on the lower side of the respective tear-off tongue with bridge form 14, as clearly shown in figure 2.

Above the tooth there is a horizontal bar, whose object is to prevent the possibility of carrying out, from above, the opening of the tear-off tongue. Such movement would allow pulling the tooth upward, releasing it from the tear-off tongue without causing the breakage of the latter.

In the prior art, the closure of the box for protecting the catheter is reversible and thus does not constitute any deterrent for an improper use thereof. The prior art does not address the problem of preventing improper uses of a central vascular catheter, but rather only that of protecting the end of the catheter from risk of contamination in the most suitable manner when the device is not manipulated. This assumes that the paramedical personnel closely follow the relevant international regulations, but of course this does not correspond to the actual situation. The present invention intends to remedy this present situation.

Figure 5 shows an embodiment of a catheter usable in combination with the protection device 1 of the invention. The central vascular catheter 20 used, e.g. for dialysis, comprises an extracorporeal portion 17, a connector 18 (situated at the end and which is fixed to the skin), and an intravascular portion 19. The extracorporeal ends 21, 2Γ of the catheter 20 respectively regard the afferent and deferent lines communicating with the respective holes (not shown in the drawing of fig. 5) made on the stem 22 of the catheter 20. The stem 22 of the intravascular portion 19 is inserted in the patient's veins, while the connector 18 is fixed to the skin of the patient by means of the lateral tabs or projections 23. The ends 21 of the catheter bear respective removable caps 24, as well as clips 25 for temporarily isolating the external part of the ends 21, 21 ' from the internal part of the ends 21 of the catheter 20, thus blocking a reflux of the body fluid.

Figure 8 clearly shows how the ends 21, 2Γ of the catheter 20 (one notes that the clips 25 are not shown here) are set on the semi-circular holes 4 of the lower shell 1". The obtainment of the half-holes 4 rather than through holes (on the wall of a single half-shell) is obviously preferable, even if the invention does not exclude the use of through holes. In order to isolate the ends 21, 21 ' of the catheter 20 from the external environment, the box 1 of the invention is closed in an inviolable manner (as comparison, see figure 2 in combination with figure 16, even though the latter corresponds with another embodiment of the invention that is still to be described). Figures 1 to 8 illustrate the first embodiment of the invention and its use with the vascular catheter for dialysis 20 shown in Fig. 5. Of course, the same invention can be obtained for central vascular catheters for drug infusion (usually smaller and with a variable number of infusion lines based on the various manufacturers and on the medical needs). Specifically, Fig. 6 shows the opening of the box 1. This occurs by inserting the tip 26 of the tool 27 in a lateral space 29 of said slot 16 which remains free even when the coupling tooth 15 is inserted in the same slot 16. A weakening line 28 (Fig. 6) is provided on the tear-off tab 14, and by making the tool 27 complete a centrifugal movement (like a lever), upward or downward as shown, the tab 14 with bridge form is sheared/torn along said weakening line 28, so that the box for protecting 1 the vascular catheter 20 can be opened (see figure 7). From figure 7, it is inferred that:

the tabs 14 were clearly "violated" and it is no longer possible to restore the initial state of the device; the tabs 14 visibly project from the second lateral side 10, so that a doctor can easily observe them;

- in addition, as a second characteristic, autonomous or possibly combinable with the preceding point, the elastic memory of said hinge 8 makes the box 1 of the invention assume a position with acute angle (e.g. of about 45°); also for this reason, a doctor can easily observe that the box 1 of the invention has been intentionally opened in a reversible manner.

Figure 7 does not show, for the sake of simplicity, the ends of the catheter.

The device 1 of figures 1 to 8 is used, of course in closed condition, for protecting the ends 21, 21 ' inside the box 1 when the catheter 20 is not used (e.g. between two dialysis cycles). Nevertheless, in the variant of the first embodiment (shown in figure 9), other semi-circular holes 4 are provided for the external outflow lines 30, 30 (e.g. directed towards the dialyzer), on the rear wall 6 opposite the front wall 5. In this case, the lines 30 are connected to the (i.e. they communicate with the) deferent and afferent lines of the catheter (the caps 24 of figure 5 have been removed). According to this variant, the box 1 protects from contaminations during dialysis. At the end of its use, the device 1 is opened and is no longer used. It is therefore a disposable device.

Figure 10 shows a variant in which the teeth 15 have a weakening notch 28'. Otherwise, the inviolable closure system is identical to that illustrated above.

Figure 11 shows (in section) a reducer fitting 31 having pyramid-like conical shape with various sectors; it can be cut/sheared at the points indicated with 3 la, 3 lb and 3 lc in order to adapt the diameter of the holes (or half-holes 4) present on the box 1 to the diameter of the lines 30 or of the ends 21, 2Γ of the catheter 20. The reducer fitting 31 is of course integral with the box 1 and it can also be formed (of course) by two mirrored halves which complete each other (the case of the semi-circular notches 4) or by a single piece (if the holes 4 are through holes and do not form semi-circular notches).

Figure 12 illustrates a box 100 according to the invention, of modular type, whose components l 'a, l 'b (upper shell) and l"a, l"b (lower shell) are initially completely separated from each other. The components are connected to each other in an irreversible or reversible manner by means of the connection means 32 shown in figures 12 and 13 which can be inviolable, i.e. irreversible, or have reversible opening and closing. In addition, it is noted that in figures 12 and 13, which show this second embodiment of the invention, hinges 8 are not provided between the half-shells. Indeed, both on the first lateral side 9 and on the second lateral side 10, only the inviolable closure means are provided, which in this case are slightly different from those described above. They have a central weakening 28" on the tear-off tab 14 and a tooth 15 with a central space 29' for the introduction of the tip 26 of tool 27 (figure 14).

The embodiment of modular type shown in figures 12, 13 and 14 is useful since the portions or components l 'b and l"b can be selected as desired, i.e. with or without holes 7 or the semi-circular holes 4 for the insertion of the external outflow lines 30. This ensures a greater flexibility in the production and composition of the box 100 of this second embodiment of the invention. In addition, such solution is justified for economical reasons, since passing from the step of protecting the catheter as such to the step of protecting during dialysis could be achieved by only changing a portion of the protection box, with savings of plastic material and thus of cost.

Figures 15, 16 and 17 shows a third embodiment of the invention, with mixed closure. It is noted that here too, according to the present general inventive concept, at least one inviolable portion is provided.

Specifically, the box 110 for protecting vascular catheters 20 according to the third embodiment of the present invention once again comprises a lower half-shell 1" and an upper half-shell , the lower half-shell comprising two portions/components l"c and l"d, and the upper half-shell comprising two portions/components l 'c and I 'd, in which the portion l"c is connected to the portion l 'c by a hinge 8 (not visible in fig. 16) and the portion l"d is also connected to the portion I 'd by a hinge 8 (visible in fig. 16). The part comprising the portions l"c and 1 'c is associated with an inviolable closure system (14 - IS IS") of the type already described above, while the part comprising the portions l"d and I 'd is associated with a reversible closing and opening system according to the prior art, constituting a flexible tab 33 only connected on one side thereof to the portion 1 'd but free to bend on the free end thereof and to be reversibly engaged and disengaged with the two projections 34 by means of its openings 35.

In a variant of this third embodiment of the invention, the base (lower half-shell) of the box 110, constituted by the components l"c and l"d, could also form a single piece.

The use of this third embodiment of the invention is the following. The vascular catheter 20 in this case preferably constitutes a drug infusion catheter, i.e. not a catheter for dialysis. It is inserted with its ends 21, 21 ' (in the already described manner) inside the protection box 110 and then the inviolable part l 'c , l"c of the device is closed. The part with reversible closing/opening, comprising the components l"d and I 'd, can be opened and closed several times by the paramedical personnel in order to perform drug infusions. Between one infusion and the next, the "small cover" 1 'd is always closed and thus ensures a physical protection against possible contamination. In this case, it is preferable to carry out only a few infusion operations, since each one of these involves a certain risk of infection for the patient. In any case, even if in this third embodiment of the invention antiseptics are not used (one notes the absence in figure 16 of the sleeve 11 for introducing the antiseptic), this third embodiment still ensures a certain protection from contaminations and above all ensures that it is impossible for anyone (even for the patient), due to the inviolable part, to accidentally separate, or easily and/or distractedly separate, the protection box 110 from the catheter 20. The described devices, preferably those completely inviolable, can be made of transparent material for monitoring possible losses of blood or other body liquid from the ends of the catheter. The inviolable closure systems described above are of course only exemplifying. In addition, the sleeves 11 for introducing the antiseptic could also be provided in a number greater than one and be distributed at various points of the box 1, for obvious reasons. The device 1 (100 or 110) could comprise gaskets made of soft/elastic material around the holes 4 (or 7) and/or around the perimeter thereof (along the edges of the half-shells). The various characteristics of the described embodiments can be freely combined together by the man skilled in the art, always remaining within the scope of the same inventive concept. The man skilled in the art can use the normal processes for producing such devices and use the materials currently on the market, so that the present invention should not be considered limited with regard to the materials employed and with regard to the relative manufacturing processes.

In summary, the present invention allows preventing the non-necessary uses of the central vascular catheter, caused by routine work or by the distraction of medical personnel. In addition, due to the greater ease of use of the central vascular catheters (without the protection box) with respect to the peripheral vascular catheters of smaller size that are more difficult to handle, it is possible that the nurse personnel will violate the guidelines regarding the suitable use of the vascular catheters, employing the latter for every type of intravenous administration. The inviolable protection box according to the present invention can thus be an optimal aid in the hands of the doctor for preventing a misuse of the vascular catheters by the paramedical personnel. In addition, the device of the present invention can be absolutely recommended in immunocompromised patients (such as those suffering from medullary aplasia) where due to the absence of immune defenses, one must ensure that absolute caution is employed in the management of the central vascular catheters.

The device of the invention can be adapted to central catheters provided with a single extracorporeal end 21 (in this case, there will be only one hole 7 or only one semi-circular hole 4 on the front wall 5 of the box 1), or provide for three or more holes 7 or three or more semi-circular holes 4 for three or more extracorporeal ends 21, 21 ', 21", etc.

Also the holes 7 or the semi-circular outlet holes 4, possibly obtained on the rear wall 6 (and lateral wall) of the device, and which correspond with the dialysis lines and the drug infusion lines, can be provided in a variable number in accordance with the different needs.

The pyramid structure 31 shown in figure 11 is adapted, as described, to the variable diameters of the infusion lines, and thus allows further increasing the flexibility and ease of use of the device of the present invention.

It may occur that the operator, during the introduction of the ends 21, 21 ' or outflow lines 30 on the semi-circular holes 4 distractedly abuts such ends 21, 21 ' or outflow lines 30 against the edge of the lower half-shell 1" in a position close to the half-holes 4 or only partially in the half-hole 4. Then, by closing the device 1 ; 100; 110, the ends 21 , 21 ' or the outflow lines 30 would remain partly or entirely "crushed" between the half-shells 1, 1".

In order to avoid this, the invention provides for a positioning means (not shown in the drawings) for the ends 21, 21 ' and for the outflow lines 30, constituted by a vertical rod integral on the lower part with the internal base of the lower half-shell 1" and bearing, on the upper part, an elastic fork of the same material as the vertical rod and as the box 1 ; 100; 110. The elastic fork is positioned a few millimeters away from the respective semi-circular hole 4. The drawback mentioned above is overcome, since the operator is obliged to insert the small tube 21, 21 ' or 30 first in the elastic positioning fork, which obliges such small tube (ends 21, 21 ' or 30) to be abutted against the half- hole 4. List of reference numbers

1 protection device (first embodiment)

100 protection device (second embodiment)

110 protection device (third embodiment) , 1" upper, lower half-shell

1 'a, 1 'b components of 1 ' (second embodiment)

I 'c, 1 'd components of 1 ' (third embodiment) l"a, l"b components of 1" (second embodiment) l"c, l"d components of 1" (third embodiment) 2 divider septum

3 small bar for lace fastening

4 (semi-circular) half- hole

5 front wall

6 rear wall

7 circular hole

8 hinge

9 first lateral side

10 second lateral side

I I sleeve

12 perimeter tooth

13 perimeter groove

14 tear-off tab (bridge)

15 coupling tooth (harpoon- like hook)

16 slot

17 extracorporeal portion

18 connector (for fixing to the skin)

19 intravascular portion

20 central vascular catheter 21, 21 ' ends

22 stem

23 tabs of 18

24 removable caps

25 clip

26 tool tip

27 tool (or forceps, common needle carrier or klemmer)

28, 28', 28" weakenings

29, 29' insertion space of 26

30 external outflow lines (for infusion or dialysis)

31 reducer fitting

32 means for the inviolable or reversible connection (modular box)

33 reversible tab closure system

34 reversible tooth closure system

35 reversible window closure system

Claims

1. A protection device (1 ; 100; 1 10) for a vascular catheter (20), constituted by two half- shells (1 ', 1") which can be joined to each other, bearing lockable closure means for maintaining the two half-shells ( , 1") in closed condition in which the ends (21, 21 ') of the catheter (20) and possible external lines (30) for dialysis or infusion of drugs are protected from the external environment, wherein said half-shells ( , 1") have one or more passage holes (7) of said ends (21, 21 ') and of the external lines (30) from the exterior towards the interior of the protection device (1; 100; 110), characterized in that said lockable closure means are at least partly of the inviolable closure type (14, 15), i.e. such to make the opening thereof impossible unless by breaking them.

2. A protection device (1 ; 100; 110) according to claim 1, characterized in that said inviolable closure means (14, 15) have an access port (29; 29') for the insertion of a tip (26) of a means or a tool (27) which causes the irreversible breakage thereof.

3. A protection device (1 ; 100; 110) according to claim 1 or 2, characterized in that it comprises at least one closable means (11), for the introduction of an antiseptic, constituted by an opening or sleeve (11) on at least one of the walls of the device.

4. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that it has at least one connection hinge (8) between the half-shells (1 \ 1").

5. A protection device (1; 100; 110) according to claim 4, characterized in that said connection hinge (8) has an elastic memory so that when the protection device (1; 100; 110) is open, the two half-shells ( , 1") tend to form a specific angle between them, e.g. comprised between about 30° and 50°.

6. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that said inviolable closure means (14, 15) have weakening notches (28') or weakening lines (28, 28") for allowing the breakage of the closure system and thus the opening of the device.

7. A protection device (1; 100; 110) according to any one of the preceding claims, and in particular according to claim 6, characterized in that said inviolable closure means (14, 15) form harpoon- like hooks (15) insertable in slots (16) of elastically deformable tabs (14), said notches (28') being provided on the tabs (14) and/or on the hooks (15).

8. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that it is formed by molding polymeric, preferably transparent material, in particular polypropylene, polyurethane or silicone material, even soft.

9. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that said passage holes (7) are formed by semi-circular holes (4, 4) obtained on the edges of the half-shells in coinciding positions and which complete each other, forming a circular-shaped passage hole (7) when the protection device (1; 100; 110) is closed.

10. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that said lockable closure means are all of the inviolable closure type (14, 15), i.e. such to make the opening thereof impossible unless by breaking them.

11. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that it is modular, i.e. it comprises a first part (l 'a, l"a) bearing at least one passage hole (7), or at least one semi-circular hole (4), which can be irreversibly or reversibly joined (32) with a second part (1 'b, l"b).

12. A protection device (1 ; 100; 110) according to claim 11, characterized in that said second part (l 'b, l"b) has at least one passage hole (7) or at least one semi-circular hole (4) for dialysis o drug infusion lines (30).

13. A protection device (1 ; 100; 110) according to claim 11, characterized in that said second part (l 'b, l"b) has neither passage holes (7) nor semi-circular holes (4) for dialysis or drug infusion lines (30).

14. A protection device (1; 100; 110) according to any one of claims 1-10, characterized in that it has a first part (l 'c, l"c) with inviolable closure (14, 15) and a second part

(I 'd, l"d) with reversible closure (33, 34, 35), wherein on the first part (l 'c, l"c) there is at least one passage hole (7) or at least one semi-circular hole (4) of the ends of the catheter (20), and wherein an element (I 'd) of said second part, constituting a portion of one of the half- shells ( ), forms a reversible opening and closing door, also possibly having at least one through passage hole (7) or at least one hole constituted by semi-circular holes (4) which complete each other, for external infusion or dialysis lines (30).

15. A protection device (1 ; 100; 110) according to any one of the preceding claims, characterized in that a reducer fitting (31) is provided at the semi-circular holes (4) for adapting to the variable diameters of the ends (21, 21 ') of the vascular catheter (20) or outflow lines (30) for the infusion of drugs or lines directed to the dialysis machine, the reducer fitting (31) having a conical-pyramid structure, with different predetermined breakage points (31a, 31b, 31c).

16. A protection device (1; 100; 110) according to claims 9-15, characterized in that a system for the precise positioning of the external lines (30) and the ends (21, 21 ') of the catheter (20) is provided in the respective semi-circular holes (4), formed by a vertical rod and an elastically expandable fork which are positioned inside the device (1; 100; 110) and are integral with the internal base of the device itself, the fork being arranged a few millimeters away from the respective semi-circular hole (4).