IT201900009918A1 - WELDING OF A PLASTIC SHEET FOR MEDICAL FILTERING DEVICE - Google Patents

Description

DESCRIPTION

TITLE: WELDING OF A PLASTIC SHEET FOR MEDICAL FILTERING DEVICE

FIELD OF APPLICATION OF THE INVENTION

The present invention is part of the field of medical filtering devices for biological material, for example blood. In particular, these are filtering devices made of soft plastic material, in particular pvc, inside which the filtering material is contained.

STATE OF THE ART

Medical filtering devices for biological material, in particular for filtering blood, are known in the state of the art. Said filtering devices generally comprise a casing made of plastic material, for example soft PVC, inside which the filtering material is contained.

The filtering devices have a generally flattened shape, for example shaped in such a way as to substantially follow the shape of the filtering material and therefore in particular provide a reduced thickness with respect to the dimensions of its width and length.

The envelope is generally made by overlapping two sheets, preferably of plastic material, which are welded together along their perimeter after placing the filter material in the central area between said sheets.

The envelope has two opposing surfaces, one that we will call the inlet side at the inlet of the material to be filtered and a surface that we will call the outlet side at the outlet of the filtered material.

Therefore in the central area of the filtering device, said opposite surfaces on the outlet side and on the inlet side, are separated and spaced from the filtering material, while in the edge of the filtering device arranged along the perimeter of the filtering material and outside it, the two opposite surfaces are in contact with each other and are preferably welded together. Said external welding allows you to seal the casing of the filtering device around the filtering material. There is also an internal seal which serves to prevent the blood from flowing to the sides of the filter material by bypassing it, said internal weld being arranged along the perimeter of the filter material and inside it, i.e. said second weld made between the output side surface, the filter material and the inlet side surface.

The filtering device further includes an inlet element and an outlet element which in technical jargon are generally called inlet port and outlet port.

The blood or biological material that must be subjected to filtration treatment enters through the inlet port, while the filtered blood or biological material comes out through the outlet port.

Said ports can be of the 90 ° or in-line type, i.e. those having 90 ° have a bend or elbow that allows them to be applied in correspondence with the central area of the filtering device and therefore in correspondence with the opposite surfaces on the outlet side and inlet side of the casing. On the contrary, the in-line port is shaped to be applied at the edge of the filtering device and therefore at the weld between the two sheets.

The ports of the 90 ° type are generally welded respectively the output port to the sheet that defines the output side surface, while the input port to the sheet that defines the input side surface of the envelope.

Their application requires that a first opening of the inlet and outlet port faces the filtering material, then towards the inside of the filtering device and a second opening faces the outside of the filtering device.

A spacer element, known in technical jargon as an expander, or also a frame, is usually inserted between the sheet that defines the output side surface and the filtering material.

Said spacer element has the purpose of creating a distance between the filtering material and the internal face of the outlet side surface.

This distance is essential to facilitate the exit of biological material or blood through the exit port. In fact, without the spacer element, the internal face of the outlet side surface and therefore also the first opening of the outlet port would tend to adhere to the filter material, hindering the exit of biological material or blood.

The spacer element that will be inserted inside is for example a retina.

In particular, the assembly of the filtering device according to the prior art provides for arranging the sheet on the inlet side on which the inlet port has already been welded at 90 °, positioning the filtering material on it, arranging the spacer element above the filter material and finally position above the sheet on the exit side on which the 90 ° inlet port has already been welded.

At this point, the inlet side and outlet side sheet are welded along the perimeter of the filtering material, preferably by high frequency or radiofrequency welding. In particular, the edge of the filtering device is made by means of an external welding arranged along the perimeter of the filtering material and preferably on the outside, where the sheet on the input side and the output side are directly in contact with each other. Said external welding allows you to seal the casing of the filtering device around the filtering material. There is also an internal seal which serves to prevent the blood from flowing to the sides of the filter material by bypassing it, said internal weld being arranged along the perimeter of the filter material and inside it, i.e. said internal weld made between the sheet on the output side, the the spacer element, the filter material and the sheet on the inlet side. The known art therefore provides that said spacer element is an additional component with respect to the output side and input side sheets. Its insertion therefore involves an additional phase in the production process, having to be positioned during assembly. It also needs to be purchased, stored and managed, affecting the final costs of the filtering device.

EXPOSURE AND ADVANTAGES OF THE FOUND

The technical problem underlying the present invention is that of making available to the art a medical filtering device and relative method and apparatus for its realization, structurally and functionally conceived to overcome one or more of the limits set out above with reference to the cited known art.

In the context of the aforementioned problem, a main purpose of the invention is to develop a medical filtering device and its method and apparatus, which simplifies its implementation by reducing its production costs and facilitating the assembly of the filtering device.

A further purpose of the invention is also to make a medical filtering device and related method and apparatus available to the technique for its realization as part of a simple rational solution that optimizes the transit of biological material and its exit from the filtering device.

These and other purposes are achieved thanks to the characteristics of the invention reported in the independent claims. The dependent claims outline preferred and / or particularly advantageous aspects of the invention.

In particular, an embodiment of the present invention makes available a medical filtering device for filtering biological material, in particular blood, comprising a filtering material enclosed in a casing which comprises an inlet element to allow the entry of the biological material to be filtered. and an outlet element for allowing the biological filtered material to exit by passing through the filtering material.

Said envelope further comprising a sheet on the output side and a sheet on the inlet side respectively defining opposite surfaces and placed respectively above and below the filtering material.

At least one of said output side sheet and / or input side sheet comprises spacer elements integrally integrated with it and able to partially distance the corresponding surface from the filtering material.

Thanks to this solution, the spacer elements are integrated into the sheet on the output side and / or the input side and this feature facilitates the assembly and construction of the filtering device.

In fact, during the assembly of said filtering device, it is not necessary to move and position an additional component in its own right as is currently the case in the known art, where the spacer elements are for example nets or spacers, which are positioned on top of the filter material and must be kept in the correct position during assembly.

All this also involves additional production costs for the management of a component other than those required for assembly.

In fact, a preferred embodiment provides that said spacer elements extend from the inner face of said surfaces in the direction of the filtering material, when the filtering device is assembled.

One embodiment provides that the input element is firmly placed on the input side sheet and the output element is firmly arranged on the output side sheet.

Furthermore, preferably said inlet element and / or outlet element are shaped at 90 °.

The term conformed at 90 ° means that they include a first opening, facing the filter material, in communication with the inside of the casing by means of a through slot on the output side surface or the input side surface; said first opening is substantially parallel to the surfaces defined by the sheet on the output side and / or the input side. Further they include a second opening facing the outside of the casing and arranged orthogonal to the first opening.

One aspect of the invention provides for optimizing the operating functionality of the filtering device.

In fact, the spacer elements can further comprise protrusions, preferably comprising a plurality of cylindrical blocks, which extend from the sheet on the inlet side and / or from the sheet on the output side, being arranged in correspondence with the resting area of the inlet and / or outlet element and facing the filter material and near the first opening.

This conformation is designed to facilitate the exit of the biological material from the outlet element as it distances its first opening from the filter material to which it would tend to adhere.

To increase the aforementioned advantage, the protrusions are arranged along the perimeter of the support area of the inlet and / or outlet element.

Therefore they detach from the filter material the entire support area of the inlet and / or outlet element.

Again to facilitate the exit of the biological material and optimize the operation of the filtering device, a feature of the invention also provides that the spacer elements comprise extensions arranged in a central area respectively of the surfaces defined by the sheet on the output side and / or the input side, said extensions being substantially straight and preferably parallel and / or orthogonal to each other.

According to an aspect of the invention, the wrapper is a film preferably of plastic material, in particular of PVC, shaped by means of at least one sheet on the input side and at least one sheet on the output side, said sheets on the output side and the input side being welded together by welding , preferably at high frequency, able to define an edge along the perimeter of the filtering material.

Preferably, the sheet on the output side and / or the input side, comprising spacer elements, is obtained by welding, preferably at high frequency, of at least one base sheet which can have a greater thickness than the base sheet from which the output side sheet is obtained and / or entrance side without spacer elements.

Preferably, said thickness must be between 0.6mm and 0.8mm, which is sufficient to make the spacer elements by welding, preferably at high frequency.

In particular, the sheet on the output side and / or the input side, from which the spacer elements extend, can be made by means of at least a first and a second base sheet superimposed and welded together by preferably high frequency or radio frequency welding where said first and second base sheet, each preferably has the same thickness as the inlet side sheet without spacer elements.

It should also be pointed out that the solution which provides for the realization of the sheet on the output side, by welding the first and second base sheets, has the advantage of simplifying the management of the components that make up the filtering device. In fact, this allows you to use the same type of sheet without the need for coding and management of new components.

At the same time it allows to have sufficient material for the realization of the spacer elements which extend from the internal surface, thanks to this excess of material.

The invention also relates to the related method for manufacturing the inlet-side sheet and / or the outlet-side sheet suitable for defining respective surfaces of a casing for a medical filtering device configured to filter biological material, in particular blood.

Said method comprises the step of carrying out on a base sheet 210a, 210b and / or 220a, 220b a welding preferably at high frequency or radiofrequency in order to realize integrated spacer elements 250 i.e. extending from said sheet 220 and / or said sheet output side 210 thus made.

In particular, the method involves:

- define, preferably by die-cutting, a first and / or a second base sheet suitable for the size of the filtering material and make the through slot at the final position of the input element or output element;

- superimposing said first and / or second base sheet on a welding counter-electrode, comprising a plurality of recesses shaped to form the spacer elements; - place the input element or the output element on said first and second overlapping base sheets and in correspondence with the slot;

- superimpose the welding electrode comprising a shaped recess designed to receive the input element or the output element;

- press the electrode and the counter electrode and perform the high frequency welding.

Thanks to this method, the processing steps for manufacturing the filtering device and its components are reduced.

In fact, the realization of the spacer elements preferably takes place simultaneously with the welding of the output or input element and substantially during the same processing phase.

A further advantage is given by the fact that the assembly step of the filtering device is also simplified by reducing the number of components to be assembled.

In fact, said method subsequently provides to position the filter material between said sheet on the output side and / or the inlet side, and perform the perimeter welding, preferably at high frequency, between the sheet on the output side and / or the inlet side to seal the envelope creating the edge. .

The invention also relates to the sheet on the output side and / or the input side for the casing of a filtering device made according to the method described above.

Furthermore, the related apparatus for the realization of this method also falls within the scope of protection of the invention.

In particular, said apparatus for high frequency or radiofrequency welding which provides for the production of the sheet on the input side and / or the sheet on the output side, comprises:

- a high frequency generator electrically connected to an electrical circuit,

- a welding press comprising a welding counter-electrode and a welding electrode, where the welding counter-electrode, made of conductive material preferably brass, defines a support surface, comprising a plurality of recesses shaped to form the spacer elements on the sheet on the input side and / or the output side sheet, during the welding of the input element or the output element on a first and / or second base sheet.

Thanks to this solution it is possible to weld the first and / or second base sheet together to make the spacer elements.

It also allows the welding of the input or output element. In fact, the welding counter electrode preferably comprises a template preferably in insulating material, suitably shaped to position the input element or the output element by inserting it through its first opening.

In particular, for this purpose, also the welding electrode comprising a shaped recess designed to contain the portion of the input element or the output element that extends from its support area.

Said objects and advantages are all achieved by the medical filtering device and the relative method and apparatus for its realization, object of the present invention, which is characterized by the provisions of the following claims.

BRIEF DESCRIPTION OF THE FIGURES

This and other characteristics will become more evident from the following description of some embodiments illustrated, purely by way of non-limiting example in the accompanying drawing tables.

- Figure 1: shows in an axonometric view from above a filtering device with casing according to the invention,

- Figure 2: is an axonometric view from below of a filtering device with casing according to the invention,

- Figure 3: exploded view of a filtering device with casing according to the invention,

- Figure 4: top view illustrates a sheet on the output side or the input side made according to the invention,

- Figure 5: illustrates in top view a first or second base sheet for the realization of an output side or input side sheet made according to the invention,

- Figure 6: is an axonometric view from above and below an inlet and / or outlet element,

- Figure 7: shows an axonometric view from above a counter electrode according to the invention,

- Figure 8: is an axonometric view from above of an electrode according to the invention,

- Figure 9: exploded axonometric view of a welding apparatus according to the invention with first and second base sheet and with input and / or output element.

DESCRIPTION OF THE FOUND

With particular reference to Figure 1, a medical filtering device 100 is shown, for filtering biological material, in particular blood.

Said filtering device 100 comprises a filtering material 1 enclosed in a casing 2.

The envelope 2 provides an inlet element 3 to allow the entry of the biological material that must be filtered and an outlet element 4 to allow the exit of the biological material once filtered.

Filtration takes place by passing biological material or blood through the filter material 1.

Said envelope 2 further comprises an outlet side sheet 210 and an inlet side sheet 220 defining opposite surfaces 21, 22 and placed respectively above and below the filtering material 1.

An embodiment shown in figures 1 and 2 provides that the input element 3 is firmly placed on the input side sheet 220 and the output element 4 is firmly arranged on the output side sheet 210.

In particular, said inlet element 3 and / or outlet element 4 can be shaped at 90 °, i.e. they comprise a first opening 31, 41, facing the filter material 1 and therefore towards the inside of the casing 2 and a second opening 32 , 42 turned towards the outside of the casing 2 and arranged orthogonal to the first opening 31, 41.

Said inlet element 3 and / or outlet element 4, shaped at 90 °, generally comprise a resting area 33, 43 and a portion 34, 44 which extends from its resting area 33, 43.

However, it is understood that even different solutions in which, for example, only the outlet element 4 is of the 90 ° type and the inlet element 3 is of the in-line type or both are in-line, fall within the scope of protection of the invention. .

In particular, said first opening 31, 41 is in communication with the inside of the envelope 2 by means of a through slot 211, 221 made on the output side sheet 21 or the input side sheet 22.

Preferably said first opening 31, 41 is substantially parallel to the surfaces 22, 21.

A preferred form provides that the through slot 211, 221 of the output side sheet 21 or the input side sheet 22, has a size such as to substantially coincide with the external perimeter 33a, 43a of the resting area 33, 43 of the input element 3 or the input element exit 4.

The size and precision of said through slot 211, 221 is very important as will be better described below.

According to an aspect of the invention, at least one of said sheets on the inlet side 220 or the outlet side 210 comprises, preferably on an internal face 22a or 21a of the respective surfaces 21, 22, spacer elements 250 integral with it, i.e. integrated therein, suitable for spacing partially said surface 22 or 21 from the filter material 1.

Said spacer elements 250 called expander in technical jargon have the purpose of creating a distance between the filtering material 1 and the internal face 21a or 22a of the surface 21, 22.

This distance is fundamental to facilitate the exit of the biological material or blood through in particular the outlet element 4 or outlet port 4. In fact, without the spacer elements 250, above all the internal face 21a would tend to adhere to the filter material 1, hindering the exit of biological material or blood.

The presence of the spacer elements 250 is especially important between the surface 21, defined by the output side sheet 210, and the filtering material 1, but this does not mean that said spacer elements 250 may also be present on the surface 22, defined by the inlet side sheet 220 or in specific configurations, are present only on surface 22.

In the following and in the figures, we will mainly refer to spacer elements placed on the surface 21, defined by the output side sheet 210, without this being limiting for the invention.

Thanks to this solution, the spacer elements 250 are completely integrated into the sheet on the output side 210 and / or the input side 220 and this feature facilitates the assembly and construction of the filtering device 100.

In fact, during the assembly of said filtering device 100, it is not necessary to move and position an additional component in its own right as currently occurs in the known art, where the spacer elements 250 are for example nets or spacers, which are positioned on top of the material filter 1 and must be kept in the correct position.

All this also involves additional production costs for the management of a component other than those required for assembly.

A preferred embodiment of the invention instead provides that said spacer elements 250 extend directly from the inner face 22a, 21a of said surface 21, 22 respectively of the sheet on the output side 210 and / or the input side 220 in the direction of the filter material 1, when the filter device 100 is assembled.

Therefore, the spacer elements 250 are an extension of the sheet 210, 220 and therefore not separated from it.

In particular, the spacer elements 250 further comprise protrusions 252 which extend from the inlet side sheet 220 and / or from the outlet side sheet 210 and which are preferably arranged in correspondence with the resting area 33, 43 of the inlet element 3 and / or exit 4.

Said protrusions 252 are turned towards the filtering material and near the first opening 31, 41 of the inlet 3 and / or outlet 4 element.

The function of the protrusions 252 is to space the first opening 31, 41 of the inlet 3 and / or outlet 4 element from the filter material 1, in such a way as to allow the passage of blood without adhesion to the filter material 1 obstruct the passage by limiting its escape.

A possible embodiment is shown in Figure 4, and provides that said protrusions 252 comprise a plurality of blocks 252a spaced apart and preferably cylindrical or similar in shape.

Said configuration is suitable for distancing the first opening 31, 41 from the filtering material 1, allowing the biological material to flow easily between one plug 252a and the other.

Further precisely to facilitate the aforementioned purpose, a preferred embodiment provides that the protrusions 252 are arranged along the perimeter 33a, 43a of the support area 33, 43 of the input element 3 and / or output element 4.

This position allows you to be at the right distance from the first opening 31, 41 and maximize its effectiveness.

A further aspect of the invention provides said spacer elements 250 comprise extensions 251 arranged in a central area of the sheet on the output side 210 and / or the input side 220, respectively.

Said extensions 251 can be, as shown in Figures 1, 3 and 4, substantially rectilinear and preferably parallel and / or orthogonal to each other.

A preferred embodiment is shown in Figures 1, 3 and 4, and shows a central straight and oblique extension 251a with respect to the edges 23 of the filtering device and a series of straight lateral extensions 251b arranged on the two sides of the central straight and oblique extension 251a orthogonally to each other; therefore said rectilinear lateral extensions 251b are parallel to the respective two adjacent edges 23 and able to form a substantially herringbone configuration.

Said embodiment allows uniformly detaching the internal face 21a or 22a from the filtering material 1.

The open and non-closed path of the extensions 251 facilitates the passage of biological material towards the outlet element 4 or inlet 3.

However, it is understood that what has been described above has an exemplary and non-limiting value, therefore any variations on the shape of the extensions 251 are considered from now on to fall within the same protective scope defined by the appended claims. For example, a form of extensions 251 that carries for example the customer's logo could, in addition to providing the aforementioned advantages, also customize and make the filtering device recognizable, without adding components or processes for the realization of said customization.

As will be described below, in order to realize said spacer elements 250 it is necessary to describe in detail the conformation and the method of making the sheet on the input side 220 and / or the output side 210 of the envelope 2, said spacer elements 250 being an integral part of said sheets input side 220 or output side 210.

One aspect of the invention provides that the envelope 2 is made using a film preferably of plastic material, in particular of PVC.

Therefore the output side sheet 210 and an input side sheet 220 is made by means of a film preferably of plastic material, in particular of PVC, said sheet 210, 220 being preferably spread and for example of rectangular shape as shown in figure 5, or circular or square etc ... having a larger size than the filter material 1.

Preferably said inlet side sheet 220 is adapted to define the inlet side surface 22, while the output side sheet 210 is adapted to define the outlet side surface 21.

Therefore the filtering material 1 is positioned between said sheets on the output side 210 and the input side 220 which are then welded together by welding, preferably at high frequency, or radio frequency.

By welding, an edge 23 is defined along the perimeter 11 of the filter material 1.

Therefore the output side sheet 210 and the input side sheet 220, spread will have a larger size than the filtering material and such as to allow the realization of said edge 23 which guarantees the sealing of the envelope 2.

In particular, the edge 23 of the filtering device is made by means of an external weld 23a arranged along the perimeter of the filtering material and preferably on the outside, where the sheet on the input side and the output side are directly in contact with each other. Said external welding 23a allows you to seal the casing of the filtering device around the filtering material. There is also preferably an internal seal 23b which serves to prevent the blood from flowing to the sides of the filter material by bypassing it, said internal seal 23b being arranged along the perimeter of the filter material and inside it, i.e. said internal seal made between the side sheet outlet, the filter material and the sheet on the inlet side.

A preferred form provides on said sheets on the output side 210 and the input side 220 there is already present, before their welding together, respectively the output element 4 or the input element 3.

Moreover, in particular, also the spacer elements 250 are already present on the output side sheet 210 and / or on the input side sheet 220 at the time of their welding around the filter material 1.

According to an aspect of the invention, in fact the sheet on the output side 210 and / or the input side 220 are made according to a method which is able to define the spacer elements 250 on said sheets 210, 220 and to weld the input element 3 and / or outlet 4, before the final assembly of the filtering device 100.

The invention also relates to the sheet on the output side 210 and / or the input side 220 for casing 2 of a filtering device 100 comprising spacer elements 250 as described above.

For example, said output side sheet 210 and / or input side 220, comprising spacer elements 250, is made from at least one base sheet 210a, 210b and / or 220a, 220b, which can have a greater thickness than the base sheet from which it is obtained. the sheet on the output side 210 and / or the input side 220 without spacer elements 250.

Preferably, said thickness must be between 0.6mm and 0.8mm, which is sufficient to make the spacer elements 250 by welding, preferably at high frequency, as will be further described below.

In particular, the output side sheet 210 and / or input side 220, from which the spacer elements 250 extend, can be made by means of at least a first and a second base sheet 210a, 210b and / or 220a, 220b superimposed and welded together by means of preferably high frequency or radio frequency welding carried out by means of an apparatus 500 which will be better described below.

The size and shape of said first and second base sheets 210a, 210b and / or 220a, 220b is substantially the same as the resulting sheet 210 and / or input side 220.

In this case, said first and second base sheets 210a, 210b and / or 220a, 220b each preferably have the same thickness as the base sheet from which the output side sheet 210 and / or input side 220 is obtained without spacer elements 250.

Therefore said first and second base sheets 210a, 210b and / or 220a, 220b, each preferably have the same thickness as the sheet on the output side 210 and / or the input side 220 without spacer elements 250.

For example, a preferable thickness of the base sheet 210a, 210b, and / or 220a, 220b is 0.35mm ± 1mm. Therefore, by overlapping the first and second base sheets 210a, 210b and / or 220a, 220b, a thickness of 0.70mm ± 1mm is obtained.

This allows to have sufficient material for the realization of the spacer elements 250 which extend from the internal face 21a and / or 22a thanks to this excess of material.

The welding of said first and second base sheets 210a, 210b and / or 220a, 220b is carried out in such a way as to realize, at the same time, the spacer elements 250, as will be better described below.

Once said first and second base sheets 210a, 210b and / or 220a, 220b have been welded to make the spacer elements 250, the output side sheet 210 and / or input side 220 that is obtained, will preferably have a thickness lower than the sum of the thicknesses of the first and second base sheet 210a, 210b and / or 220a, 220b and substantially similar to the thickness of the sheet on the input side 220 and / or the output side 210, in which the spacer elements 250 are not made.

In particular, the spacer elements 250 will protrude from said thickness.

This does not preclude the fact that possible variants are also included in the invention which provide for the production of the sheet on the output side 210 and / or the input side 220, with relative spacer elements 250, using instead of the first and second base sheets 210a, 210b and / or 220a, 220b a only sheet of greater thickness and such as to be sufficient for the realization of said spacer elements 250.

Equally protected by the invention is also the possible use of more than two overlapping sheets in order, for example, to obtain spacer elements 250 with greater extension.

It should also be noted that the solution that provides for the realization of the sheet on the output side 210 and / or the input side 220, by welding the first and second base sheets 210a, 210b and / or 220a, 220b has the advantage of simplifying the management of the components that constitute the filtering device 100.

In fact, this allows the same type of base sheet to be used both to make the sheet on the output side 210 and / or the input side 220 with or without spacers 250.

Therefore it does not require coding and management of new components.

A preferred form provides that on said first and second base sheets 210a, 210b and / or 220a, 220b there is already present, before their welding together, the through slot 211, 221 of the output side sheet 210 or the input side sheet 220.

Said through slot 211, 221 is in correspondence with the input element 3 or output element 4 which will be welded on said first and second base sheets 210a, 210b and / or 220a, 220b.

Preferably said through slot 211, 221 has a size such as to substantially coincide with the external perimeter 33a, 43a of the support area 33, 43 of the input element 3 or output element 4.

The size and precision of said through slot 211, 221 is very important, due to the melting of material which occurs during the welding of the base sheet or sheets 210a, 210b and / or 220a, 220b.

In particular, the amount of material that melts is very critical as it could obstruct the first opening 31, 41 of the inlet 3 or outlet 4 element.

In fact, if said through slot 211, 221 were smaller, there would be an excess of molten material; conversely, if said through slot 211, 221 were larger there would be little molten material.

A further preferred form provides that on said first and second base sheets 210a, 210b and / or 220a, 220b there are also through holes which can be used to interface with any templates for positioning the base sheet 210a, 210b and / or 220a, 220b during welding.

The subject of the invention therefore also relates to the method for producing an inlet side sheet 220 and / or said outlet side sheet 210 adapted to respectively define a surface 22, 21 of a casing 2 for filtering device 100 configured to filter biological material, in particular blood. .

Said method comprises the step of carrying out on said input side sheet 220 and / or said output side sheet 210 a welding preferably at high frequency or radiofrequency to realize integrated spacer elements 250, i.e. extending from said input side sheet 220 and / or said sheet output side 210.

Said welding is preferably carried out on a base sheet 210a, 210b and / or 220a, 220b having a thickness, for example, of between 0.6mm and 0.8mm, sufficient to make the spacer elements 250.

Said welding will be set in such a way as to obtain, at the end of the processing, a sheet on the input side 220 and / or the output side 210 having a thickness substantially equal to the thickness of the sheet on the input side 220 and / or the output side 210 on which the spacer elements are not made. 250.

The spacer elements 250 will protrude from said thickness.

In particular, a preferred embodiment of the method provides for:

- define, preferably by punching, the first and / or second base sheet 210a, 210b or 220a, 220b of suitable size for the size of the filtering material and make the through slot 211, 221 in correspondence with the final position that the input element 3 or output element 4;

- superimposing said first and / or second base sheet 210a, 210b or 220a, 220b on a welding counter-electrode 50, comprising a plurality of recesses 51 shaped to form the spacer elements 250;

- position the input element 3 or the output element 4 on said first and / or second base sheet 210a, 210b or 220a, 220b overlapping and in correspondence with the slot 211, 221;

- superimpose the welding electrode 60 comprising a shaped groove 61 suitable for receiving the input element 3 or the output element 4 and in particular able to contain the portion 34, 44 of the input element 3 or the element outlet 4 which extends from its resting area 33, 43; - press the electrode 60 and the counter electrode 50 and perform the high frequency welding.

The various specific phases relating to high frequency or radio frequency welding are not reported in the description of the method as they are known to a person skilled in the art, such as the cooling and opening phases of the electrode / counter electrode or the power supply and activation phases or weld insulation.

Therefore, the realization of the spacer elements 250 preferably takes place simultaneously with the welding of the output element 4 or the input element 3. In particular this is important for the realization of the protrusions 252 placed in correspondence with the resting area 33, 43 of the input element 3 output element 4.

In fact, one could think of welding by making in a first phase only the spacer elements 250 and in a second phase the output element 4 or inlet 3 thus carrying out two welds. However, with the second welding, it would not be possible to create the protrusions 252 and in particular the blocks 252a below the resting area 33, 43.

Therefore, the invention, in addition to carrying out two processes in a single phase, allows the creation of the protrusions 252 and in particular the fundamental dowels 252a by modeling a high frequency or radiofrequency welding on three dimensions.

Said method can further provide for positioning the input element 3 or the output element 4 on said first and / or second base sheet 210a, 210b or 220a, 220b by using a template 52 mechanically associated with the welding counter electrode 50 and suitably shaped to receive the first opening 31, 41 of the inlet element 3 or the outlet element 4.

The invention also relates to the sheet on the output side 210 and / or the input side 220 for casing 2 of a filtering device 100 made according to the method described above.

After the production of said sheets on the output side 210 and / or the input side 220 with integrated spacer elements 250 and with the input element 3 or the output element 4 welded, the assembly of the various components is continued for the realization of the filter device 100.

In particular, the filtering material is arranged between said sheet on the output side 210 and / or the input side 220 and first the internal 23b and then the external perimeter welding 23a which creates the edge 23 is carried out in rapid succession.

It should be noted that not necessarily both the output side sheets 210 and / or the input side 220 are made using the method described above, but generally a preferred embodiment provides that the output side sheet 210 is made according to the method according to the invention and therefore includes the elements integrated 250 spacers.

The input side sheet 220, which does not always require spacer elements 250, can instead be made using a single base sheet to which the input element 3 is welded.

Therefore the filtering device 100 thus made will have the spacer elements 250 only on the internal face 21a of the surface 21 defined by the output side sheet 210, while the internal face 22a of the surface 22 defined by the input side sheet 220 will be smooth, i.e. without spacer elements.

The invention also relates to the apparatus 500 for high frequency or radiofrequency welding which provides for the production of the output side sheet 210 and / or the input side sheet 220 adapted to respectively define the surface 21, 22 of the casing 2, in particular by welding a first and / or a second base sheet 210a, 210b and / or 220a, 220b.

According to the known art, high frequency or radio frequency welding equipment works by means of high frequency current, for example in the order of 27-40 MegaHertz.

According to the known art, said apparatuses 500 include:

- a high frequency generator electrically connected to an electrical circuit,

- a welding press comprising a welding counter electrode 50 and a welding electrode 60.

Following the simultaneous action of the pressure exerted by the welding press and the molecular agitation induced, on the material to be welded, by the high frequency current, the temperature rises which causes the melting of said material to be welded and the consequent welding.

The electrode 60 is also called the active electrode as it transmits the current to the counter electrode 50, which is instead called passive, as it is configured to receive the current that comes from the electrode 60.

Said apparatus 500 preferably comprises a welding counter-electrode 50, made of conductive material preferably brass, which defines a supporting surface 55, comprising a plurality of recesses 51 shaped to form the spacer elements 250 on the base sheet 210a, 210b, or 220a, 220b for the realization of the input side sheet 220 and / or the output side sheet 210, preferably during the welding of the input element 3 or the output element 4 on the base sheets 210a, 210b, or 220a, 220b.

Thanks to this conformation, the welding counter-electrode 50 not only allows to weld the input element 3 or the output element 4, but also allows the spacer elements 250 to be produced at the same time, which preferably takes place by welding the base sheets 210a, 210b, or 220a , 220b between them.

According to one aspect of the invention, the welding counter electrode 50 comprises a template 52 preferably made of insulating material, suitably shaped to position the input element 3 or the output element 4 by inserting it through its first opening 31, 41.

In particular, the template 52 is configured to withstand temperatures in a range between 80/100 degrees and is preferably made of Teflon.

The apparatus 500 further comprises a welding electrode 60 comprising a shaped groove 61 adapted to contain the portion 34, 44 of the input element 3 or of the output element 4 which extends from its support area 33, 43.

A preferred embodiment provides that the recesses 51 of the welding counter electrode 50 comprise rectilinear slots 51a preferably blind and preferably parallel and / or orthogonal to each other and centrally arranged in correspondence with the central area of the sheet on the input side 220 and / or the output side 210, i.e. of the first and / or second sheet 210a, 210b and / or 220a, 220b when positioned for welding.

A preferred embodiment is shown in Figure 7 and shows the straight slots 51a arranged in such a way as to obtain an output side sheet 210 or input side sheet 220 shaped in such a way as to carry a central extension 251a rectilinear and oblique with respect to the edges 23 of the filtering device and a series of rectilinear lateral extensions 251b arranged on the two sides of the central rectilinear and oblique extension 251a in an orthogonal manner to each other; therefore rectilinear lateral extensions 251b are obtained which are parallel to the respective two adjacent edges 23 and capable of substantially forming a herringbone configuration.

The advantages of said embodiment have already been described previously.

However, it should be pointed out that what has been described above has an exemplary and non-limiting value, therefore any variations on the shape of the recesses 51 are considered from now on to fall within the same protective scope defined by the claims reported below. For example, a form of recesses 51 with a conformation such as to define extensions 251 bearing, for example, the customer's logo could, in addition to providing the aforementioned advantages, also customize and make the filtering device recognizable, without adding components or processes for the realization of said personalization since it would be carried out with the desired conformation, during the welding described above in the method.

A further embodiment provides that the recesses 51 of the welding counter electrode 50 comprise holes 51b, preferably blind arranged, in correspondence with the resting area 43, 33, preferably of the perimeter 33a, 43a, of the outlet element 4 and / or input 3 when positioned on the input side sheet 220 and / or the output side sheet 210 i.e. on the first and / or second base sheet 210a, 210b or 220a, 220b for welding.

However, it is understood that what has been described above has an exemplary and non-limiting value, therefore any detailed variations that may be necessary for technical and / or functional reasons, are considered from now on to fall within the same protective scope defined by the claims reported below.

Claims (22)

CLAIMS 1. Medical filtering device (100) for filtering biological material in particular blood, comprising a filtering material (1) enclosed in a casing (2) which comprises an inlet element (3) to allow the entry of the biological material to be filtered and an outlet element (4) to allow the biological material filtered to exit by passing through the filter material (1), said casing (2) further comprising an outlet side sheet (210) and an inlet side sheet (220) respectively defining surfaces (21, 22) opposite each other and placed respectively above and below the filter material (1), characterized in that said output side sheet (210) and / or input side sheet (220) comprises spacer elements ( 250) integrally integrated with it and able to partially distance the corresponding surface (22, 21) from the filtering material (1). Filter device (100) according to claim 1, wherein said spacer elements (250) extend from the inner face (22a, 21a) of said surface (22, 21) in the direction of the filter material (1), when the device filter (100) is assembled. Filter device (100) according to any one of the preceding claims, wherein the input element (3) is firmly arranged on the inlet side sheet (220) and the output element (4) is firmly disposed on the output side sheet (210) and in which preferably said inlet element (3) and / or outlet element (4) are shaped at 90 °, i.e. they comprise a first opening (31, 41), facing the filter material (1), in communication with the inside of the envelope (2) by means of a through slot (211, 221) of the output side sheet (210) or input side sheet (220), said first opening (31, 41) being substantially parallel to the surfaces (22 , 21) and a second opening (32, 42) facing outwards of the casing (2) and arranged orthogonal to the first opening (31, 41). 4. Filtering device (100) according to any one of the preceding claims, in which the through slot (211, 221) of the output side sheet (210) or input side sheet (220), has a size such as to substantially coincide with an external perimeter (33a, 43a) of a resting area (33, 43) of the inlet element (3) or outlet element (4). Filter device (100) according to any one of the preceding claims, wherein the spacer elements (250) further comprise protrusions (252), preferably comprising a plurality of cylindrical blocks (252a), which extend from the inlet side sheet (220) and / or from the output side sheet (210) being arranged in correspondence with the resting area (33, 43) of the inlet (3) and / or outlet (4) element and facing the filter material and near the first opening (31, 41). Filtering device (100) according to any one of the preceding claims, in which the protrusions (252) are arranged along the perimeter (33a, 43a) of the resting area (33, 43) of the inlet element (3) and / or exit (4). Filtering device (100) according to any one of the preceding claims, wherein said spacer elements (250) comprise extensions (251) arranged in a central area respectively of the surface (21, 22), said extensions (251) being substantially rectilinear and preferably parallel and / or orthogonal to each other. Filter device (100) according to any one of the preceding claims, in which the inlet side sheet (220) and the outlet side sheet (210) is a film preferably of plastic material, in particular of PVC, said output side sheets (210 ) and inlet side (220) being welded together by welding, preferably at high frequency, able to define an edge (23) along the perimeter (11) of the filter material (1). Filter device (100) according to any one of the preceding claims, wherein the sheet on the output side (210) and / or the input side (220), from which the spacer elements (250) extend, is made from a base sheet ( 210a, 210b and / or 220a, 220b) having a thickness greater than the base sheet (210a, 210b and / or 220a, 220b), the output side (210) and / or the input side (220) without spacer elements (250), preferably said thickness being comprised between 0,6mm and 0,8mm, and sufficient to realize the spacer elements (250) by welding, preferably at high frequency. Filter device (100) according to any one of the preceding claims, wherein the sheet on the output side (210) and / or the input side (220) from which the spacer elements (250) extend, is made by means of at least a first and a second base sheet (210a, 210b and / or 220a, 220b), superimposed and welded together by preferably high frequency welding, suitable for making the spacer elements (250), where said first and second base sheets (210a, 210b and / or 220a, 220b), preferably each have the same thickness of the sheet on the output side (210) and / or the input side (220) without spacer elements (250). 11. Method for making an inlet side sheet (220) and / or said outlet side sheet (210) adapted to respectively define a surface (22, 21) of an enclosure (2) for filtering device (100) configured to filter biological material in particular blood, characterized in that it comprises the step of carrying out a welding preferably at high frequency or radiofrequency on a base sheet (210a, 210b and / or 220a, 220b) to realize integrated spacer elements (250), i.e. they extend from said input side sheet (220) and / or said output side sheet (210) thus made. 12. Method according to claim 11 which provides for: -defining, preferably by punching, a first and / or a second base sheet (210a, 210b and / or 220a, 220b) of a size suitable for the size of the filtering material and making the through slot (211, 221) in correspondence with the position end of the input element (3) or output element (4); - superimposing said first and / or second base sheet (210a, 210b and / or 220a, 220b) on a welding counter electrode (50), comprising a plurality of recesses (51) shaped to form the spacer elements (250); - positioning the input element (3) or the output element (4) on said first and / or a second base sheet (210a, 210b and / or 220a, 220b) superimposed and in correspondence with the slot (211, 221); - superimpose the welding electrode (60) comprising a shaped groove (61) designed to receive the input element (3) or the output element (4); - press the electrode (60) and the counter electrode (50) and perform the high frequency welding. Method according to any one of claims 11 to 12, which provides for positioning the input element (3) or the output element (4) on said first and / or second base sheet (210a, 210b and / or 220a, 220b) by means of a template (52) mechanically associated with the welding counter electrode (50) and suitably shaped to receive the first opening (31, 41) of the input element (3) or the output element ( 4). Method according to any one of claims 11 to 13, which provides for positioning the filtering material between said sheet on the output side (210) and / or the input side (220), and performing the perimeter welding, preferably at high frequency, between the output side (210) and / or input side (220) sheet to seal the envelope (2) creating the edge (23). 15. Apparatus (500) for high frequency or radiofrequency welding which provides for the production of the sheet on the input side (220) and / or the sheet on the output side (210), adapted to respectively define a surface (22, 21) of an enclosure (2), for filtering device (100), said apparatus (500) comprising: - a high frequency generator electrically connected to an electrical circuit, - a welding press comprising a welding counter electrode (50) and a welding electrode (60), where the welding counter electrode (50), made of conductive material preferably brass, is characterized in that it defines a supporting surface (55) , comprising a plurality of recesses (51) shaped to form the spacer elements (250) on the input side sheet (220) and / or the output side sheet (210), during the welding of the input element (3) or the output element (4) on a first and / or second base sheet (210a, 210b and / or 220a, 220b). Apparatus (500) according to claim 15, wherein the welding counter electrode (50) comprises a template (52) preferably made of insulating material, suitably shaped to position the input element (3) or the output element (4) inserting it through its first opening (31, 41). Apparatus (500) according to claim 16, wherein the template (52) is configured to withstand temperatures of 80/100 degrees and is preferably made of Teflon. Apparatus (500) according to claim 15, wherein the welding electrode (60) comprising a shaped recess (61) adapted to contain the portion (34, 44) of the input element (3) or of the element outlet (4) which extends from its support area (33, 43). 19. Apparatus (500) according to any one of claims 15 to 18, wherein the recesses (51) of the welding counter electrode (50) comprise straight slots (51a) preferably blind and preferably parallel and / or orthogonal to each other and centrally arranged in correspondence with the central area of the first and / or second base sheet (210a, 210b and / or 220a, 220b) when positioned for welding. 20. Apparatus (500) according to any one of claims 15 to 19, wherein the recesses (51) of the welding counter electrode (50) comprise holes (51b) preferably blind arranged in correspondence with the resting area (43, 33), preferably of the perimeter (33a, 43a), of the outlet (4) and / or inlet (3) element when positioned for welding. 21. Output side (210) and / or input side (220) sheet for casing (2) of a filtering device (100) made according to any one of claims 1 to 13. 22. Output side (210) and / or input side (220) sheet for casing (2) of a filtering device (100) made according to the method of any one of claims 11 to 14.