Technical Field of the Invention

The invention relates to a safety container for the removal of blades, needles and other disposable objects of the type used in surgery and the final recount thereof.

5 Background art

It is known that the prevention of percutaneous occupational wounds in operating theatres is currently at a non-optimal level and the problem of the prevention of percutaneous occupational wounds is still significant, especially in the step of detaching the disposable blade from the scalpel 10 handle.

In the operating theatre, two surgical instruments are almost exclusively used which can cause percutaneous wounds:

Suture needles and hypodermic needles which are defined as sharp risk instruments;

15 - Scalpels with removable disposable blade and disposable scalpels with fixed blade are defined as sharp risk instruments.

Different units of scalpel blades and suture needles are used during “standard” surgery.

In orthopaedic surgery, but especially in cardiac surgery, the number of 20 such instruments increases considerably, especially with regard to suture needles. Therefore, the problem of the prevention of percutaneous occupational injuries, or those which can occur in the exercise of the medical or nursing profession in operating theatres, is quite felt.

Two types of scalpels are used in operating theatres: those which are 25 entirely disposable (handle and blade), as the steel blade is firmly assembled to the handle which is always made of plastic material and after use are entirely disposed of; those with reusable scalpel handles which are entirely made of steel, therefore sterilizable and usable infinitely; the blade which is generally made of steel, but can also be made of other material such as carbon, is instead always disposable. In surgery in operating theatres, the following activities are carried out in chronological order:

- on a plane next to the operating bed, called the serving table, a sterile cloth is laid where the various surgical instruments necessary for the operation are placed.

- the professional nurse (called an instrumentalist) who must mount the disposable blade on the handle of the scalpel uses two methods which are by now standardized.

- to take the blade between the fingers and apply it to the handle of the scalpel;

- to grasp it with a surgical clamp and insert it on the handle of the scalpel;

- after the surgeon has used the scalpel blade, he passes it to the instrumentalist who must change the blade and mount the next one on the handle.

The systems of known type therefore leave the problem of the safe removal of disposable blades unresolved, do not include a storage and final count of needle cover, blade cover, gauze pads, hypodermic needles and syringes, trocars, cardiac catheters, drainage needles and other instruments which thereby risk being dispersed in the operating theatre and not being available for the final recount at the end of the surgery. The invention in question, on the other hand, effectively solves such problems.

It is also known that in the current surgical procedures carried out in the operating theatre a significant problem is the final control count of the devices used, such as suture needles; disposable blades for scalpels; disposable scalpels; drainage needles; as well as other disposable material such as: gauze pads; hypodermic syringes; hypodermic needles; syringe needle covers; blade covers for disposable scalpels and other. Regarding the count of both the devices and the other material present in the checklist drawn up before the surgery and updated during the same, it is known that this must be identical to the count carried out in the checklist post-surgery, to avoid the risk of retention of such objects in the surgical site with even serious criminal and civil consequences.

At present there are no satisfactory instruments available to the surgical team to solve this problem, on the contrary they are extremely lacking.

In fact, the containers currently on the market are basically “disarmers” for removing scalpel blades, absolutely inefficient for such a purpose, since they only serve to disarm the blade of the scalpel and because they also risk the percutaneous injury of the operators upon the detachment of the blade (not being provided with any protective shielding, as on the other hand the container has) and do not allow an efficient counting of the suture needles, not having any instrument for counting the gauze pads, for storing the blade covers and the needle covers, no support for positioning a possible hypodermic syringe, drainage needle, scalpels and other devices and also no container for the final disposal of scalpels, hypodermic syringes, and other possible devices.

The problems unresolved by the containers currently in use are made particularly felt by the fact that the final recount of gauzes, blade covers and needle covers and used devices has become mandatory also and above all as a result of episodes which have occurred in post-surgery such as retention of such materials in the already-closed surgical site, with criminal and civil consequences for the operating team.

Currently, to solve or at least limit such a problem, not very effective and lacking instruments are used to solve the problems described above.

It has also been found that upon the removal from the scalpel, the blade tends to snap with a spring effect causing its dispersion or worse to injure the instrumentalist; to prevent such a problem, the invention provides a protected disengagement channel in which to insert the handle and remove the blade in total safety and reliability.

Object of the Invention A first object of the invention is to allow the storage and recount of a large number of disposable objects used in the operating theatre in a simple and reliable manner, minimizing the margins of counting error.

A further object is to obtain the simple and protected removal of the disposable blade from the scalpel handle, significantly reducing percutaneous occupational wounds.

In general, the present invention is intended to provide a safety container for the removal, storage and final counting of cutting edges, sharp objects and other disposable objects which allows to overcome the drawbacks of the already known solutions.

Summary of the invention

These objects have been achieved by developing a container according to at least one of the appended claims.

A first advantage is the ease of use and reliability of the final count of all the disposable objects, whether cutting edges, sharp objects or other objects which can be used in surgery.

A second advantage is that the container object of the invention shows an efficiency and an extremely improved safety with respect to the known systems and also induces a better and safer “modus operandi” of the operators, to whom it allows to find all the aforementioned instruments positioned in an extremely intuitive system.

A further advantage is that the container allows to ergonomically position the devices in use and also, not secondary, to minimize the danger of percutaneous occupational wounds from cutting edges and points.

A further advantage is that the removal manoeuvre of the disposable blade of the scalpel is much simpler and above all protected with respect to the known systems.

A further advantage is that the container is low cost.

A further advantage is that it is possible to flexibly compose the container using one or more types of alternative shelves for storing the suture needles depending on the type of surgery and the number of needles to be safely stored.

List of Drawings

These and other advantages will be better understood by anyone skilled in the art from the description below and the accompanying drawings, given as non-limiting example, in which: figure 1 shows a perspective view of a container according to the invention in a closed, non-operating configuration; figure 2 shows a perspective view of a container according to the invention in an open configuration as output from the plastic moulding step; figure 3 shows a container according to the invention in top view and in the open operating configuration; figure 4 shows a container according to the invention in perspective view and in the open operating configuration; figure 5 schematically shows the use of the container, seen in plan view, with the various types of disposable objects to be removed inserted in the respective sections; figures 6, 6a, 6b show a variant of the container in perspective view and closed configuration, in front view, and in perspective top view in the open configuration; figures 7 and 8 show the use of the container of figure 6 during and after surgery. figures 9a-9c illustrate the mechanism of the blade release system in the operating steps thereof; figure 10 shows a variant of the container in perspective view and the open configuration; figures 11 and 12 show the use of the container of figure 10 during surgery and after surgery in the recount step, figures 13, 13a, 14 show a variant of the container respectively in the open configuration, in the open configuration in top view and in the closed configuration. figure 15 shows a detail of a preferred embodiment of the container closure.

Detailed Description

With reference to the accompanying drawings, a safety container is described according to the invention for the removal, storage and final count of cutting edges, sharp objects and other disposable surgical material such as needle covers, hypodermic syringes, blade covers and gauze pads.

The container comprises a box 1 in a sterilizable material, preferably a plastic material, comprising a main compartment 2 and a lid 3 which is foldable with respect to the main compartment, for example by means of a hinged joint 32.

Advantageously, the compartment 2 can have on the support surface an adhesive layer 48, for example a double-sided adhesive tape, to allow the device to be fixed on the serving table during use.

Preferably, the container is obtained by moulding transparent or coloured plastic in a single or multiple footprint, comprising the compartment 2, the lid 3 and the joint hinge 32.

The container further comprises fixing means 4, 5 for the stable closure of the main compartment with the lid, consisting for example of a tab 4 of the lid 3 which engages with a tooth 5 of the compartment 2.

Preferably, the fixing means 4, 5 for the stable closure of the main compartment with the lid can be reopened in order to allow additional recounts after the closure of the container.

In the embodiment illustrated in figure 15, the fixing means comprise first reopenable pressure closing means 51 in order to allow additional recounts after the closure of the container, second irreversible pressure closing means 52 in order to prevent the accidental opening of the container, in which the second closing means are activatable by exerting a greater pressure with respect to the pressure necessary to activate the reversible closing means, so as to ensure that the irreversible closure occurs with a voluntary operation by the operator. By way of example, the first and second reversible and irreversible closing means comprise raised teeth 51, 52 of increasing height, capable of engaging with a corresponding slot 57 of the closing element 4.

With particular reference to figure 2, the main compartment comprises a first plurality of well sections 8-12 separated by respective walls 33-36 to contain a corresponding number of different disposable objects to be removed and means for releasing disposable blades from scalpels and the containment thereof in one of said separate sections.

According to a preferred embodiment of the invention, the lid 3 also comprises at least one section, preferably three sections 14-16 separated by respective walls 37-38, possibly provided with a retention bottom, for example adhesive, 17, 18 for containing and retaining needle covers, blade covers and gauze pads.

In this case, the bottom of the section will therefore be adhesive, while the bottom of a section of the compartment 2 intended for the containment of metal objects such as disposable blades and suture needles can be either magnetic or adhesive. Advantageously, the well sections of the compartment 2 are deep, for example from 3 to 5 centimetres, to limit the risk of accidental operator contact with hazardous disposable objects stored in the sections, such as used cutting edges or sharp objects. Otherwise, the sections of the lid 3, if included, can be less deep, for example 0.5 centimetres, because they are used for the storage and final recount of objects which are unable to cause percutaneous occupational wounds, such as gauze pads, needle covers and blade covers.

In an embodiment, one of the sections of the lid 3 can also be used to house an explanatory prospectus for the use of the device.

Advantageously, the main compartment comprises one or more notches 21 , 30 arranged at the respective sections 8, 12 made for example by the front wall of the compartment 2 on the side of use (fig.1 ), or of the side walls (fig.10), shaped to engage with corresponding surgical instruments for example syringes, scalpels, trocars, cardiac catheters, drainage needles and other devices and facilitate the stable support thereof during use, for example a notch 21 shaped like a semicircle for the stable support of a syringe and a second notch 30 of quadrangular shape for the stable support of a scalpel.

In the example illustrated in figures 7, 8 the shelf 14 is provided with multiple, horizontally or vertically positioned, parallelepiped-shaped retention channels 50 which can be provided in the inner walls thereof with longitudinal reliefs or hooks for an improved, stable retention of gauze pads prior to use and final storage after use. Accordingly, in order to retain the pads, such a compartment can also lack double-sided adhesive. Another variant relates to the storage of needle covers in the compartment 8, the same as the positioning of the hypodermic syringe. The blade cover of the disposable scalpel is also stored in compartment 12, the same as the positioning of the disposable scalpel. In the case of surgery in which the disposable scalpel is not use, the steel scalpel can be positioned in compartment 12, which also has an additional positioning in compartment 10 by means of the notch 22.

In order to seal the opening in the closing configuration of the container, also to avoid the loss of contents in the subsequent handling, the lid 3 can comprise tabs 6, 6’ of shape and size corresponding to said support notches 21 , 30 so as to reconstitute the continuity of the wall of the compartment 2 in the closing configuration.

Furthermore, the main compartment 2 is provided with a further notch 22 arranged at a respective section 10 for positioning the steel scalpel in use. According to an aspect of the invention, the blade release system 20 comprises a slit 27 accessible from the outside of the compartment 2 for the insertion of a disposable blade in a closed release channel consisting of a first contrast wall 23 integral with the compartment 2 and arranged at a section 10 and a second contrast wall 24 integral with an element 26, possibly movable with respect to the compartment 2 and superimposable on the first wall 23 in an operating release position. Preferably, the movable element 26 has at least the visible upper wall 56 in transparent material to allow viewing the release manoeuvre by an operator and, in the embodiment of figures 1-8, comprises an elongated body articulated at one end 25 with respect to the compartment 2 to pass from a projecting position to the operating release position superimposed on the wall 23 and the section 10 and further comprising stable fixing means 29, 40 for fixing in said operating position.

For example, the means 29, 40 can comprise a harpoon shape of the end 29 to be interlocked or coupled in a hole 40 integral with the compartment 2.

Advantageously, the mobility of the element 26 allows to produce the container by moulding in a single footprint with the element 26 projecting from the compartment 2 and then fold it into an operating position to create the closed release channel, whose upper wall (in the use position) acts as a barrier if during the detachment of the blade from the scalpel it can disperse outside the box or, even worse, injure the healthcare operator.

The contrast walls of the release means can be shaped in various manners with reference to figure 9a, preferably the slit 27 is provided with means for disengaging the blade comprising a first contact surface 24 placed on the movable part 26 and a second contact surface 23 placed on the container. When the scalpel blade, including the handle, is inserted into the slit 27, as shown in figure 9b, the inclination of the handle causes the reliefs 23 to flex the rear part of the blade, which during the extraction of the handle from the slit 27 goes in contrast in the wall 24a, disengages from the handle and falls into the section 10, as shown in figure 9c.

With reference to figure 5, disposable devices are shown which can be safely removed (cutting edges and sharp objects), as well as other objects (needle cover, blade cover, gauze pads) and effectively prepared for the final recount, by virtue of the invention.

The needle covers of hypodermic syringes and the blade covers of disposable scalpels are stored in section 14 with possible adhesive.

The used gauze pads are stored in section 16 with possible adhesive. The package leaflet with instructions for use is inserted, for example, in section 15, for example glued.

The ready-to-use or reusable syringe is positioned in section 8; similarly, the ready-to-use scalpels (both disposable and with interchangeable blade) are positioned in section 12.

Used suture needles are stored in spaces 9 and 11 ; it should be noted that there are two spaces as such risk instruments are by far the most used in the operating theatre, so much so that in cardiac surgery tens and sometimes more than a hundred are used.

For the latter extreme cases, additional shelves 43 have been designed to be stacked in spaces 9 and 11.

Preferably, the shelves 43 have raised edges 45 and a relief 46 placed in the centre of the shelf to facilitate gripping, which must be carried out with surgical clamps.

The disposable blades of the scalpels are detached and any individual hypodermic needles are stored in section 10. Advantageously, as shown for example in figure 6, to facilitate the storage of the blades falling from the slit 27, it is included that the bottom 41 of the portion of the section 10 below the release system means is inclined to facilitate the sliding of the blades in the section itself, making it more visible in the final recount. Disposable scalpels, used disposable syringes including the needle, any trocars and other devices, such as cardiac catheters, are positioned for the recount in compartment 13, separated from the remaining sections by a wall 39.

With reference to figures 6-8, a second embodiment of the invention is illustrated.

In this example, where parts having the same technical function were assigned the same numerical references already adopted, some modifications were made. In particular:

- the tab 4 has been extended throughout the width of the compartment 2 in order to increase the support surface in an open configuration and to cover the notches 21 , 30 without the need to include the tabs 6, 6’;

- the sections 9, 11 for the disposal of suture needles were merged into a single section.

With reference to figures 10-12, a further preferred variant of the container is described. Also in this example, parts having the same technical function were assigned the same numerical references as previously adopted.

In this preferred embodiment of the invention, the lid 3 comprises only the section 15 with the instructions for use and must not contain any objects. In this case, the bottom of the section will therefore not be adhesive or magnetic.

The main compartment comprises one or more notches 21 , 30 arranged at the opposite sides of an elongated section 130 arranged along the joint 32 and in which the disposable scalpels and disposable syringes are positioned during work (fig.11 )

The section 130 is advantageously provided with a raised abutment 131 extended for a part of the width of the section 130 with a “V” support for supporting the needle of a syringe in use, and a possible further abutment 132 for approaching the tip of a scalpel in use, which prevents the deterioration of the blade thereof.

Preferably, in use both the scalpel and the syringe are positioned on the same side to avoid problems of use by the operator.

At the end of the surgery (fig.12), the disposable scalpels, used disposable syringes including needles, any trocars and other devices, for example cardiac catheters, are positioned in the section 130 for the recount.

The main compartment 2 further comprises a succession of spaces 80, 9, 100, 110 separated by respective walls 81 , 91,101 , 111 , of which: the needle covers of the hypodermic syringes and the blade covers of the disposable scalpels are stored in section 100 with possible adhesive; the large gauze pads G are possibly placed in individual seats 54 and stored once used during the surgery (G1) in section 80; the small gauze pads G2 are possibly placed in individual seats 84 and stored once used during the surgery (G3) in section 80A

Advantageously, the pads G and G2 are in a predetermined number, for example five and multiples thereof, and are always returned to the trays 80 and 80A to facilitate the recount. used suture needles are stored in section 9, possibly with additional stackable shelves 43 of the type already described and can comprise at least one numerable magnetic base, for example with 10 places for needles, also applicable possibly to one or more of said additional shelves for the stable retention of needles and metal objects and/or a pad or sponge 55 numbered, for example with 20 places, in perforable material for the stable retention of needles and perforating metal objects. Figure 13 schematically illustrates a magnetic bottom 60’ with a central cut 61 which allows the insertion of the relief 46 of the shelves 43; the disposable blades of the scalpels are detached in section 110 with the mechanism described in figure 9 and any individual hypodermic needles are stored. As in the case of figure 6, to facilitate the storage of the blades falling from the slit 27 it is included that the bottom 112 of the portion of the section 110 below the release system means is inclined and provided with reliefs, preferably in the form of a semicircle to facilitate the sliding of the blades in the section itself, making it more visible in the final recount.

In the example of fig.10, in order to seal the opening in the closing configuration of the container, also to avoid the loss of contents in the subsequent handling, the compartment 2 can include a peripheral abutment 113 on which the edge 114 of the lid 3 superimposes in the closing configuration with a depth equal to or greater than the support notches 21 , 30 so as to reconstitute the continuity of the wall of the compartment 2 in the closing configuration.

Referring to figures 13-15, a further preferred embodiment of the container of the invention is illustrated, in which parts having the same technical function have been assigned the same numerical references already adopted.

In this embodiment, the main compartment 2 comprises: a section 9 provided with means for the storage and stable retention of suture needles, preferably provided with additional stackable shelves 43 and at least one magnetic bottom possibly applicable to one or more of said additional shelves for the stable retention of needles and metal objects and/or a pad 55 made of perforable material for the stable retention of needles and perforating metal objects 59; release means 20 for removing scalpel blades and storing them in a section 110, preferably comprising an element 26 with at least the visible upper wall 56 in transparent material to allow the view of the release manoeuvre by an operator; a section 100 for the storage of needle covers of hypodermic syringes and blade covers of disposable scalpels, and small gauze pads G2 positioned in individual seats 84; a section 80 divided into a plurality of seats 54, for example five, for the separate storage of individual gauze pads,

Furthermore, in this embodiment, the fixing means 4, 5 for the stable closure of the main compartment with the lid are preferably of the type comprising both first reopenable pressure closing means 51 and second irreversible pressure closing means 52, for example a pair of teeth 51 , 52 which engage under pressure with a slot 57 of the closing hook 4 and are operable in succession by applying increasing pressure by the operator. Advantageously, in this embodiment it is possible to flexibly compose the same container by combining the section 9 for storing the suture needles with one or more types of lids (magnetic 43 and/or pad 55) depending on the type of surgery and the number of needles to be safely stored. By way of example, it will be possible to include at least three different configurations: first configuration, adapted to fewer needles with a magnetic bottom 60 of the section 9; a second configuration adapted to an intermediate number of needles which includes the section 9 with a foam bottom 55, preferably numbered for the storage and final count of the suture needles; third configuration, adapted to a greater number of needles which includes the insertion into the section 9 of several additional stackable shelves 43.

Furthermore, preferably, as shown in figure 13, the inner face 15 of the lid 3 has visual instructions for carrying out the operation of releasing the blades.

Advantageously, in order to ensure the positioning of the lid 3 for correct vision by the operator, the hinge 32 allows the lid to be opened overturned and held in place, for example by virtue of the plasticity of the hinge itself. The present invention has been described according to preferred embodiments, but equivalent variants can be conceived without departing from the scope of protection granted.