Patent ID: 12195721

DETAILED DESCRIPTION OF THE DRAWINGS

With reference to the figures mentioned, a device for producing globules of adipose tissue is denoted in its entirety by reference number1.

The adipose tissue used in most applications is human adipose tissue.

The device1comprises a service unit2and a single-use kit3which may be housed in the service unit2.

The single-use kit3comprises a working chamber4, a circuit5for introducing a tissue sample to be treated into the working chamber4, a circuit6for drawing the globules of adipose tissue produced from the working chamber4, a circuit7for introducing a solution for washing the tissue sample into the working chamber4, and a size-reducing circuit8which connects an exit route4aof the working chamber4to an entry route4bof the working chamber4.

The kit3also comprises a circuit12for discharging the scraps of the treated sample. The kit3finally comprises a bypass circuit9for bypassing the size-reducing circuit8. The working chamber4is formed by a flexible bag10.

In particular the bag10is constituted by two suitably shaped sheets peripherally welded together.

Between the welded edges of the two sheets, one end of connection fittings11a,11b,11c,11d,11e,11f,11gis arranged to connect the working chamber4to the various circuits of the kit3.

The fitting11a, comprising in particular a tube having a single entry and double exit, connects the exit route4aof the working chamber4to the drawing circuit6and size-reducing circuit8.

The fitting11b, comprising in particular a smaller lumen-shaped tube with a single entry and single exit, connects the entry route4bof the working chamber4to the size-reducing circuit8.

The fitting11bextends substantially inside the working chamber4along a direction which intersects the prolongation4einside the working chamber4of an entry route4eof the adipose tissue sample to be treated.

The fitting11c, comprising in particular a tube having a single entry and single exit, connects the entry route4cof the working chamber4to the bypass circuit9.

The fitting11d, comprising in particular a tube with a single entry and single exit, connects the exit route4dof the working chamber4to the discharge circuit12.

The fitting11e, comprising in particular a tube with a single entry and double exit, connects the entry route4eof the working chamber4to the circuit5for introducing the adipose tissue sample to be treated.

The fitting11f, comprising in particular a tube having a single entry and single exit, connects the entry route4fof the working chamber4to the circuit7for introducing a solution for washing.

Eventually the fitting11g, comprising in particular a tube having a single entry and single exit, connects the entry route4gof the working chamber4to an auxiliary circuit13.

The bag10can be made of PVC for medical applications and have a certain capacity, for example 200 ml.

The size-reducing circuit8comprises a flexible tube14,15and a mechanical size-reducing unit16.

The flexible tube14,15comprises a first tube section14that connects the exit route4aof the working chamber4to the entry route of the size-reducing unit16and a second, lower, lumen-shaped tube section15which connects the exit route of the size-reducing unit16to the entry route4bof the working chamber4.

The mechanical size-reducing unit16, which does not require electricity for its operation, comprises a series of for example three spiral blades17,18,19with a decreasing pitch and arranged in cascade fashion to the spiral blades17,18,19, a series for example of two filters20,21with slots crossed at right angles.

In particular the mechanical size-reducing unit16comprises a shell22,23with an axial extension, preferably cylindrical and formed by two halves sealedly connected, which encloses the spiral blades17,18,19and the filters20,21.

The shell22,23has at each of its bases a lumen-shaped connection fitting24,25different between them at a respective section of lumen-shaped tube14,15different between them.

The spiral blades17,18,19and filters20,21are stacked coaxially inside the shell22,23.

Suitable spacers27,28are also provided in the shell22,23and are equipped with through openings adapted to mutually separate the spiral blades17,18,19and a spacer29equipped with through openings adapted to separate the last spiral blade19from the filters20,21.

A further spacer26equipped with through openings separates the first spiral blade17from the base adjacent to the shell22,23.

By way of example, the three spiral blades have a pitch of respectively 2 mm, 1.5 mm, 1 mm, while the filters20,21with slots have a smaller width than the pitch of the last spiral blade29, for example a width equal to 0.8 mm.

The size-reducing circuit8also comprises a clamping element30, for example a tube-restricting clamp acting on the second section of tube15.

The bypass circuit9also comprises a flexible tube31equipped with a clamping element32, for example a tube-restricting clamp.

The flexible tube31connects the size-reducing circuit8upstream of the size-reducing unit16through a three-way fitting33.

The circuit5for introducing the sample to be treated may comprise a flexible tube (not shown) connected to the fitting11eand equipped with a closure cap (not shown) and a clamping element (not shown), for example a tube-restricting clamp.

The flexible tube of the circuit5for introducing the sample to be treated is connectable to a container of the sample to be treated, for example a syringe.

The drawing circuit6comprises a flexible tube36connected to the fitting11aand equipped with a closure cap37and a connecting element38, for example a T-shaped manifold.

The flexible tube of the drawing circuit6is connectable via the connecting element38to a container of globules of adipose tissue, for example a syringe39.

The circuit7for introducing a solution for washing comprises a flexible tube34connected to the fitting11fand equipped with a closure cap35and a clamping element (not shown), for example a tube-restricting clamp.

The flexible tube34of the circuit7for introducing the solution for washing1sconnectable to a container of washing solution (not shown).

The washing solution is for example a saline solution.

The circuit12for discharging the washing solution also comprises a flexible tube (not shown) connected to the fitting11dand equipped with a closure cap (not shown) and a clamping element (not shown), for example a tube-restricting clamp.

The flexible tube of the discharging circuit12is connectable to a container of the scrap product, for example a bag.

Advantageously the service unit2has an electronic controller (not shown) and means for the forced circulation of the tissue sample through the size-reducing circuit8.

The forced circulation means comprise a primary peristaltic pump40coupled to the flexible tube14,15, particularly to an arcuate portion of the first section of tube14.

The service unit2also comprises an auxiliary peristaltic pump41coupled to the flexible tube34of the circuit7for introducing the solution for washing, particularly to an arcuate portion of the flexible tube34.

The primary peristaltic pump40and the secondary peristaltic pump41are connected to the electronic controller.

The service unit2further comprises a user interface42which is also connected to the electronic controller.

The interface42comprises at least one selector of the time and speed of activation of said forced circulation means.

More precisely, a selector of the time and speed of activation of the primary peristaltic pump40is envisaged, and a selector of the time and speed of activation of the secondary peristaltic pump41is envisaged.

The interface42is a graphic type, preferably a touch screen display.

Specifically, the touch screen display has ten buttons, with two buttons43aacting as a selector of the time of activation of the primary peristaltic pump40, two buttons43bacting as a selector for the speed of activation of the primary peristaltic pump40, a button43cacting as a start and stop of the trituration/washing functions, two buttons44aacting as a selector of the time of activation of the secondary peristaltic pump41, two buttons44bacting as a selector of speed of activation of the secondary peristaltic pump41, a button44cacting as a start and stop of the loading of fresh washing solution into the working chamber4.

The graphic interface42is completed by a timer45for the display of the time remaining to complete the trituration or washing.

To provide visual feedback of the operation in progress, the background of a button changes color when the same is activated.

The service unit2comprises a plate-like weight-bearing frame having a flat horizontal rest wall46and a flat, slightly inclined vertical wall47provided with a support48a,48bfor positioning the working chamber4, a support49for positioning the drawing circuit6on one side of the working chamber4, a support50for positioning the size-reducing circuit8on the opposite side of the working chamber4, a support51for positioning the interface42above the working chamber4, and supports52,53for positioning the primary peristaltic pump40and the auxiliary peristaltic pump41at the opposite sides of the interface42.

At the rear, the flat rest wall46has a ballast (not shown) in order to increase the stability of the system.

The support48a,48bis formed for example by a bottom bracket48areleasably housing the lower portion of the flexible bag10and an upper gripper48bthat releasably clamps the upper portion of the flexible bag10.

The support49is formed for example by a housing which can hold and release the syringe39and the support50is formed for example by a housing which can hold and release the shell22,23of the size-reducing unit16.

The supports51,52,53are instead simply fastening housings, for example by means of screws or bolts, for the peristaltic pumps40,41and the interface42.

The service unit2also comprises an electric power supply (not shown) required to supply electric energy to the active components, in particular a low voltage, direct current power supply, for example a power supply of at least 50 W, 24V.

A typical working session with the device1is composed of the following four stages: preparation of the kit3, loading the kit3, treating the sample, and extraction of the reduced sample.

The single-use kit3is supplied in sterile packaging which should be opened under a laminar flow hood in order to minimize the risk of contamination, in particular, of the internal part of the circuit. For the preparation of the kit3, it is therefore necessary to prepare all the material necessary for loading the kit in the hood as well as its hermetic closure, i.e. the container of washing solution, the syringe with the sample to be treated, the drawing syringe or batch of syringes39, and the scrap product container.

Once the material for performing the loading of the kit is prepared in the hood, proceed as follows.

Close the tube of the discharge circuit12with the clamp, remove the cap from the tube of the discharge circuit12and connect the tube of the discharge circuit12to the scrap product collection container with its clamp closed.

Close the tube of the washing circuit7with the clamp, remove the cap from the tube of the washing circuit7and connect the container with the washing solution.

At this point open the washing circuit7and let a quantity flow into the bag, for example approximately equal to that of the tissue that will be treated.

Close the container of the washing solution.

Close the tube of the circuit5for introducing the sample with the clamp.

Open the cap of the circuit5for introducing the sample, connect the latter to the syringe containing the sample to be treated, and inject the latter into the flexible bag10.

Close the tube of the circuit5for introducing the sample with the clamp, disconnect the loading syringe, close the cap of the tube of the circuit5for introducing the sample and open the clamp.

At the end of the indicated operations the kit is sealed, thus it can be removed from the hood and housed in the service unit2.

Depending on need, the service unit2can also be kept under the hood, in this case the kit3is housed therein and should be moved into the area envisaged for its use.

In the case of direct use in the operating theatre, all the steps which are envisaged under a laminar flow hood must be carried out in the sterile area of the operating room.

For the correct operation of the system, in particular for that concerning the separation of the lipid and aqueous phases, the service unit2and the kit3housed therein must be used in a vertical position.

Once the service unit is connected to its own power supply, the treatment of the tissue sample can proceed according to two modes: trituration/washing or washing only.

A third feature of the device makes it possible to load fresh washing solution into the bag10for further treatment sessions.

The two modes of trituration/washing are activated with the same button after selecting circuit8or9by means of the selective opening of the clamp30or clamp32.

In trituration mode, wherein the clamp30is open on the size-reducing circuit8downstream of the size-reducing unit16and the clamp32on the bypass circuit9is closed, the sample is forced to pass into the size-reducing unit16together with the saline solution.

The sample undergoes a subsequent fragmentation in the size-reducing unit16thanks to the work of the spiral blades and/or slotted filters present therein.

The difference in the diameters of the entry and exit routes of the size-reducing unit16entails a difference in the flow across the same, and a consequent difference in the speed of the fluid exiting the flexible bag10and that entering. The difference in speed produces a continuous remixing between the aqueous and lipid phases, which is indispensable for the homogeneity and purity of the final product. At the end of the treatment, the lipid phase will form a suspension over the aqueous phase which can be eliminated by making it flow into the suitable bag for collecting scrap products, after the opening of the respective clamp. The treatment can be repeated, at the discretion of the operator.

For the washing mode, it is necessary to close the clamp30downstream of the size-reducing unit16and open the other clamp32. In this case the sample and saline solution are simply recirculated; the adipose tissue is not reduced m size but only washed externally. Also in this case the cycle can be repeated.

For each mode, the speed of the primary peristaltic pump40and the duration of the treatment must be set, after which pressing the start button43cinitiates the selected procedure automatically until after the set time has elapsed.

The loading of substances into the working chamber4can be carried out in two different ways. In the standard way, a defined amount of saline solution is introduced into the working chamber4before starting the trituration/washing or only washing procedure. The standard way is that used in the preliminary phase of the kit's preparation. The washing solution will only be eliminated at the end of the treatment. The second way instead envisages the continuous introduction of saline solution, regulated by the auxiliary peristaltic pump41, during the washing/trituration or washing procedure. Since the volume of the kit3is limited, it will be necessary to keep the clamp on the scrap collection bag open so as to collect the saline solution introduced.

At the end of the treatment the lipid phase spontaneously collects by floating up to the top of the bag10and is ready to be retrieved and used. The aqueous phase thereunder can be made to flow into the scrap bag or kept in order to facilitate the subsequent operation for extracting the sample reduced in size.

The extraction takes place by means of the syringe39or a batch of syringes39.

It is sufficient to draw the desired amount of globules of adipose tissue with the syringe39, remove the syringe39and use the extracted product according to need.

In the case where a batch of syringes39is used, it is necessary to close the connector of each of them with their cap as soon as they are separated from the kit3.

The device for producing globules of adipose tissue as conceived herein is susceptible to many modifications and variations, all falling within the scope of the inventive concept; furthermore, all the details are replaceable by technically equivalent elements.

In practice the materials used, as well as the dimensions, can be any according to the needs and the state of the art.