Machine for extracorporeal photopheresis of biological fluids

Abstract

A machine (1) for extracorporeal photopheresis of biological fluids comprises: - a support body (2) for receiving a circuit (C) for the extracorporeal circulation of the biological fluids, wherein the circuit (C) comprises at least one bag (S) containing biological fluids, at least one collection container (D) of biological fluids to be treated, at least one delivery conduit (E) of the biological fluids connected to at least the bag (S) and to the collection container (D); - pumping means (3) of the biological fluids through the delivery conduit (E); - irradiation means (4) by means of a UVA ray lamp of the collection container (D); and wherein the machine comprises at least one containing box (7) defining a containing space (8) for containing the collection container (D) and at least one safety chamber (18) arranged below and in communication with the containing space (8) so as to collect any possible spillage of the biological fluids from the collection container (D), wherein the safety chamber (18) has at least one bottom wall (7b) and two side walls (7a), the safety chamber (18) being sealed at the at least one bottom wall (7b) and at the two side walls (7a).

Description

TECHNICAL FIELD

[0001] The present invention relates to a machine for extracorporeal photopheresis of biological fluids, in particular blood or components thereof. BACKGROUND

[0002] Extracorporeal photopheresis (ECP) is a therapy capable of modifying the immune response of a living organism, hence it is called immunomodulatory therapy, the first phase of which comprises the separation of white blood cells from the blood by centrifugation, which in the medical field is called leukapheresis; the separation is made in order to collect a cell concentrate of lymphocytes and monocytes.

[0003] The second phase of photopheresis comprises the addition of a photosensitizing drug to the collected cells and the exposure of the whole to UVA type ultraviolet light; the photosensitizing drug used is psoralen and the currently preferred drug used is 8-methoxypsoralen (8-MOP).

[0004] At the end of the two phases described above which constitute photopheresis, the suspension of cells containing the photoactivated drug is reinfused into the patient's body, so it is clear that in this case the photopheresis is extracorporeal and autologous.

[0005] Currently, in order to promote and stimulate the mediated and tolerant immune response, the practice of extracorporeal photopheresis is used for the treatment of various important diseases in the case of cutaneous T-cell lymphoma, in the case of rejection after bone marrow transplantation, solid organ such as heart, lung, liver and kidney, and in the case of autoimmune diseases such as progressive systemic sclerosis, rheumatoid arthritis, psoriatic arthritis and systemic lupus erythematosus.

[0006] With regard to the known documents relating to photopheresis of blood and its derivatives, attention is drawn to the following documents: US 4,573,962, US 6,491,656, EP 1 576 973 and EP 1 867 355.

[0007] The teaching of US 4,573,962 relates to a device suitable for irradiating blood to photoactivate a reagent substance mixed with the blood, the device being also suitable for reinfusing the irradiated blood into the patient's body.

[0008] US 6,491,656 describes and claims a device suitable for controlling the movement of fluids during extracorporeal blood treatment. The device comprises a housing comprising a cavity, a plurality of inlets and outlets converging into the cavity, the inlets being suitable for conveying fluids inside the housing, the outlets being suitable for the treated fluids. Inside the housing there is at least one valve and one filtering element.

[0009] EP 1 576 973 relates to a device suitable for irradiating blood and, thanks to the intervention of a processor, comprises the possibility of allowing an external irradiation dose; for this device, a bag is used which is provided with a tortuous channel, the inlet tube of which is placed at the outlet portion upstream of a pump, the outlet tube of which is placed at the position where the inlet of a recirculation bag is located.

[0010] EP 1 867 355, filed by the same Applicant, describes a set of photo-separation substitution devices comprising an irradiation chamber, an accumulation container, an incubator and a plurality of conduits, wherein a container of biological fluid to be irradiated is placed in the irradiation chamber, the accumulation container is used for intermediate blood storage, the incubator is connected to the storage tank, and the plurality of conduits is used to contain and transport the biological fluid.

[0011] The device described in EP 1 867 355 further comprises: closure means operable to control the flow of biological fluid through the conduits and containers, an optical hematocrit level reader, a pressure sensor, and a fluid presence sensor adapted to detect any leakage of fluid from the containers.

[0012] These devices of known type, with particular reference to EP 1 867 355, indeed have some drawbacks.

[0013] In particular, these devices are not able to protect the components of the relative device in the event of breakage of the container of biological fluid, with consequent spillage of the fluid itself, causing contamination of the electrical and electronic components.

[0014] Another drawback of these devices of known type is that it is difficult to easily detect any breakage of the container of biological fluid. SUMMARY

[0015] The main object of the present application is to design a machine for extracorporeal photo-separation substitution of biological fluids which allows to protect the components of the machine in the event of breakage of the container of biological fluid to be treated, thus avoiding contamination of the components.

[0016] Within this object, an object of the present application is to effectively and promptly detect any spillage of biological fluid from the relative container.

[0017] Another object of the present application is to design a machine for extracorporeal photo-separation substitution of biological fluids which allows to overcome the above-mentioned drawbacks of the prior art in a simple, reasonable, easy, effective use and low cost solution.

[0018] The above objects are achieved by a machine for extracorporeal photo-separation substitution of biological fluids according to claim 1. BRIEF DESCRIPTION OF DRAWINGS

[0019] Further features and advantages of the present application will become more apparent from the description of a preferred, but not exclusive, embodiment of a machine for extracorporeal photopheresis of biological fluids, illustrated by way of an indicative, but non-limiting example in the annexed tables of drawings, in which:

[0020] Figure 1 is an axonometric view of the machine according to the present application, in which the containment box is in the operating position;

[0021] Figure 2 is Figure 1 is an axonometric view of the machine in which the containment box is in the insertion / removal position;

[0022] Figure 3 is Figure 1 is an axonometric view of the machine in which the containment box is in the additional insertion / removal position;

[0023] Figure 4 is Figure 3 is an axonometric view of the machine in which the containment box is open;

[0024] Figure 5 is Figure 1 is a rear view of the machine;

[0025] Figure 6 is Figure 1 is a front view of the containment box of the machine; and

[0026] Figure 7 is Figure 1 is an exploded axonometric view of the irradiation device of the machine. DETAILED DESCRIPTION

[0027] With particular reference to these drawings, reference number 1 indicates in general a machine for extracorporeal photopheresis of biological fluids.

[0028] The biological fluid to be treated is generally a cell concentrate of lymphocytes and mononuclear cells to which a photosensitive drug is added.

[0029] The machine 1 comprises a carrier body 2 for receiving a circuit C for the extracorporeal circulation of a biological fluid, in which said circuit C comprises at least one bag S containing the biological fluid, at least one collection container D of the biological fluid to be treated, and at least one delivery conduit E of the biological fluid connected to the bag S and to the collection container D.

[0030] The carrier body 2 then supports a pumping device 3, for example of the peristaltic pump type, of the biological fluid flowing through the delivery conduit E and supports an irradiation device 4 by means of a UVA ray lamp of the collection container D in order to activate the aforesaid photosensitive drug.

[0031] Preferably, the irradiation device 4 is of the LED type, which has greater wavelength stability of the UVA rays compared to neon or fluorescent lamps, and enables the emitted associated light beam to be distributed accurately and concentrated.

[0032] Conveniently, the machine 1 also comprises a hematocrit reader 5, a closure device 6 of the delivery catheter E and / or of a portion thereof, which can be operated manually and / or automatically to allow / prevent the passage of operating fluid therethrough, and pressure detection means 16 adapted to detect the presence of overpressure along the circuit C.

[0033] According to the present application, the machine 1 comprises at least one containment box 7, which defines a containment space 8 for containing the collection container D, and at least one safety chamber 18, which is arranged below and in communication with the containment space 8, so as to collect any possible spillage of biological fluid from the collection container D.

[0034] More specifically, the containment box 7 defines a resting plane of the collection container D, which is inclined with respect to the horizontal plane and is preferably arranged vertically, whereby the safety chamber 18 is arranged at a lower level than the containment space 8.

[0035] The containment box 7 defines one or more lateral walls 7a and at least one bottom wall 7b, the lateral walls 7a and the bottom wall 7b delimiting the safety chamber 18. Preferably, on the other hand, the safety chamber 18 is in communication with the containment space 8.

[0036] More in detail, the lateral walls 7a and the bottom wall 7b hermetically seal the safety chamber 18.

[0037] Conveniently, the safety chamber 18 has a volume greater than or equal to that of the collection container D, so as to be able to contain all the processed biological fluid in the event of rupture of the collection container itself.

[0038] Preferably, the machine 1 comprises detection means 12 for detecting the presence of biological fluid inside the safety chamber 18.

[0039] In a preferred embodiment, the detection means 12 comprise at least one sensor of the optical type. In other words, the detection means 12 comprise an emitter of a light beam and a receiver of said light beam (not visible in detail in the figures), which is then varied in the event of interception of any droplet of biological fluid leaking from the collection container D.

[0040] Conveniently, the machine 1 is provided with an electronic control unit, not shown in detail in the drawings, operatively connected to the detection device 12, in particular to the relative receiver. When the receiver receives a luminous signal different from the standard signal, the electronic control unit is programmed to emit an alarm signal of the acoustic and / or visual type and to prevent the operation thereof, for example by intervening on the pumping device 3 and / or on the closure device 6.

[0041] More specifically, the detection device 12 is arranged outside the safety chamber 18 so that the relative light beam can intercept the bottom wall 7b. In the embodiment shown in the drawings, the light beam emitter 12 is located below the bottom wall 7b. In turn, at least one portion of the bottom wall 7b is made of a material transparent to light, in particular the portion intercepted by the light emitted by the emitter 12.

[0042] Advantageously, the containment box 7 comprises a delivery device 13 of the biological fluid which delivers the biological fluid to a collection seat 15 of the biological fluid accessible to the detection device 12.

[0043] More specifically, the collection seat 15 is arranged inside the safety chamber 18 and the detection device 12 is arranged so that the relative light beam can pass through the collection seat itself.

[0044] More in detail, the delivery device 13 comprises at least one pair of inclined walls 14 placed inside the safety chamber 18 and converging towards the collection seat 15 of the biological fluid.

[0045] In the embodiment shown in the drawings, the delivery device 13 is arranged in the position where the bottom wall 7b is located and, in particular, the pair of inclined walls 14 defines at least one stretch of the bottom wall 7b.

[0046] The collection seat 15 defines a recess with respect to the inclined walls 14 and is delimited by two containment walls 15a which, in turn, are inclined with respect to the inclined walls 14. In the preferred embodiment shown in the drawings, the delivery device 13 comprises two collection seats 15 arranged side by side in the point where the converging area of the inclined walls 14 which define the bottom wall 7b is located. The emitter 12 is therefore associated with the carrier body 2 so as to be arranged, in use, below the collection seat 15 during the operation of the machine 1.

[0047] Advantageously, the containment box 7 is associated in a movable manner with the carrier body 2 between at least one operating position, in which the containment box 7 is arranged in the position where the irradiation device 4 is located, and at least one insertion / removal position, in which the containment box 7 is moved away from the irradiation device 4 with respect to the operating position to allow the insertion / removal of the collection container D.

[0048] In the preferred embodiment illustrated in the attached drawings, the containment space 8 is open both on the sides and on top, so as to allow the ventilation and cooling of the biological fluid contained in the collection container D during the irradiation phase thereof.

[0049] In the preferred embodiment illustrated in the attached drawings, the containment box 7 has a substantially box-like configuration and has two containment walls 7c, which are arranged facing the collection container D and are arranged on two sides of the collection container D opposite each other.

[0050] The containment walls 7c are arranged facing the irradiation device 4 in use and are made of transparent material.

[0051] A relative opening is defined between the containment walls 7c, at the position of the containment space 8, while the side walls 7a and the bottom wall 7b are placed at the position of the safety chamber 18. However, different embodiments of the containment box 7 providing a different configuration, while maintaining the same functionality, cannot be ruled out.

[0052] Advantageously, the containment box 7 is contained inside the carrier 2 in the operating position and is arranged at least partially outside the carrier in the insertion / removal position.

[0053] More specifically, the carrier 2 comprises a housing seat 9 of the housing of the containment box 7, which is arranged inside the housing seat 9 in the operating position and is at least partially outside the housing seat itself in the insertion / removal position.

[0054] Conveniently, the irradiation device 4 is arranged at the position where the housing seat 9 is located, so as to intercept the collection container D passing through the containment walls 7c when the containment box 7 is in the operating position.

[0055] The above-mentioned detection device 12 is arranged below the collection seat 15 when the containment box 7 is in the operating position.

[0056] Preferably, the containment box 7 comprises at least one openable portion 10 to allow access to the containment space 8. The openable portion 10 is movable between an open configuration, in which it allows the placement / removal of the collection container D in / from the space 8, and a closed configuration, in which the space 8 is not accessible from the outside.

[0057] More specifically, the openable portion 10 is movable between the open configuration and the closed configuration when the containment box 7 is in the insertion / removal position.

[0058] In the embodiment illustrated in the attached drawings, the openable portion 10 is defined at the position of the containment walls 7c.

[0059] Suitably, a plurality of retaining elements 11, also known as pins, are arranged inside the containment box 7 for interacting with the collection container D to limit the position of the containment box 7 inside the containment space 8.

[0060] The containing box 7 is associated with the carrier 2 at least in a sliding manner between an operating position and a home position, in which the containing box 7 is at least partially arranged outside the housing seat 9 and substantially aligned with the position occupied by the containing box itself in the operating position.

[0061] In a particular embodiment, the home position can correspond to an insertion / removal position.

[0062] In the preferred embodiment illustrated in the attached figures, the containing box 7 is moved in rotation in association with the carrier 2 between the home position and the insertion / removal position.

[0063] More specifically, in this embodiment, the carrier 2 has two slots (not visible in detail in the figures) elongated in shape and opposite each other, in which the relative pivot 20 associated with the containing box 7 is engaged. The pivot 20, sliding along the relative slot, thus allows the containing box 7 to move from the operating position to the home position and vice versa, while the pivot 20, due to the effect of the rotation around the relative axis X, allows the containing box 7 to move from the home position to the insertion / removal position and vice versa.

[0064] Advantageously, the resting plane defined by the containing box 7, and in particular by the containing space 8, is arranged substantially vertically in the operating position.

[0065] In the embodiment illustrated in the attached figures, the resting plane defined by the containing box 7 is then arranged substantially horizontally in the insertion / removal position.

[0066] The operation of the present application is as follows.

[0067] After the circuit C has been prepared and assembled and the bag S containing the biological fluid has been prepared, the collection container D is inserted into the containing box 7.

[0068] This operation is performed by moving the containing box 7 from the operating position in which it is initially found to the insertion / removal position.

[0069] In particular, the containing box 7 is made to slide with respect to the carrier 2 so as to bring the containing box 7 from the operating position to the home position, after which the containing box 7 is made to rotate around the axis X defined by the pivot 20 so as to bring the containing box 7 to the insertion / removal position.

[0070] After having reached the insertion / removal position, the openable portion 10 is moved from the closed configuration to the open configuration, thus making the containing space 8 accessible.

[0071] In this way, the collection container D can be inserted into the containing space 8 and blocked by the retaining element 11.

[0072] Next, the openable portion 10 is returned to the closed position and the containing box 7 is returned to the operating position.

[0073] At this point, the photopheresis treatment can be started, so by acting on the pumping means 3 and on the closing means 6, the biological fluid is made to flow through the circuit C and, therefore, also through the inside of the collection container D.

[0074] During the operation, the collection container D is irradiated by the irradiation means 4 in order to activate the photosensitive drug contained in the biological fluid.

[0075] After the treatment of the biological fluid, it is reintroduced into the patient.

[0076] During the treatment, if the collection container D is broken, the overflowing biological fluid falls towards the inclined wall 14 which conveys it to the collection seat 15, where it is identified by the detection means 12.

[0077] In this case, as a result of the signal received by the detection means 12, the electronic control unit sends an alarm signal and interrupts the operation of the machine.

[0078] The biological fluid that can flow from the collection container D is then collected in the safety chamber 18, which is sealed by the lateral wall 7a and by the bottom wall 7b, preventing the biological fluid from overflowing outside.

[0079] In practice it has been determined that the described invention achieves the intended purposes and, in particular, it has been emphasized that the photopheresis machine to which the present invention relates, thanks to the presence of the containment box for defining the relative containment space and of the safety chamber placed under the containment space itself, allows to protect the operator and the various components of the machine from the contamination by the biological fluid that can be infected in the event of leakage of the biological fluid from the relative collection container.

[0080] In particular, the safety chamber makes it possible to seal the biological fluid that accidentally or defectively flows from the relative collection container. At the same time, the detection means make it possible to quickly detect the leakage of the biological fluid and interrupt the operation of the machine.

[0081] Moreover, the possibility of moving the containment box between the operating position and the insertion / removal position allows, on the one hand, to facilitate the introduction of the collection container into the containment box and, on the other hand, to keep the collection container in the vertical position during irradiation, thus optimizing the irradiation process.

Claims

1. A machine (1) for extracorporeal photopheresis of biological fluids, comprising: - a support body (2) for receiving a circuit (C) for the extracorporeal circulation of a biological fluid, wherein said circuit (C) comprises at least one bag (S) containing said biological fluid, at least one collection container (D) of biological fluid to be treated, at least one transfer conduit (E) of said biological fluid connected to said bag (S) and to said collection container (D); - pumping means (3) of said biological fluid through said transfer conduit (E); - irradiation means (4) by means of a UVA ray lamp of said collection container (D); said machine (1) comprising at least one containing box (7) defining a containing space (8) for containing said collection container (D) and at least one safety chamber (18) arranged below and in communication with said containing space (8) so as to collect any possible spillage of said biological fluid from said collection container (D), wherein said safety chamber (18) has at least one bottom wall (7b) and two side walls (7a), said safety chamber (18) being sealed at said at least one bottom wall (7b) and at said two side walls (7a), wherein said containing space (8) is open both laterally and on top, thus allowing the ventilation and cooling of said collection container (D) during the irradiation phase of the biological liquid contained therein, characterized in that the volume of said safety chamber (18) is greater than or equal to the volume of said collection container (D), further characterized in that said containing box (7) is movably associated with said support body (2) between at least one operating position, in which said containing box (7) is arranged in a position in which said irradiation means (4) are located, and at least one insertion / removal position, in which said containing box (7) is distanced from said irradiation means (4) with respect to said operating position so as to allow the insertion / removal of said collection container (D); wherein said containing space (8) is in communication with the outside at least laterally and on top, wherein said support body (2) comprises a housing seat (9) for the housing of said containing box (7), said containing box (7) being arranged inside said housing seat (9) in said operating position and being at least partially outside said housing seat (9) itself in said insertion / removal position, and said irradiation means (4) being arranged in a position in which said housing seat (9) is located; further characterized in that said containing box (7) is slidably associated with said support body (2) between said operating position and an original position, in which said containing box (7) is at least partially arranged outside said housing seat (9) and is substantially aligned with the position occupied by said containing box (7) itself in said operating position, wherein said containing box (7) is rotatably movable in association with said support body (2) between said original position and said insertion / removal position, wherein said containing box (7) defines a resting plane of said collection container (D), said resting plane being arranged substantially vertically in said operating position; wherein said resting plane is arranged substantially horizontally in said insertion / removal position.

2. The machine (1) according to claim 1, characterized in that, comprising detection means (12) which detect the presence of biological fluid inside said safety chamber (18).

3. The machine (1) according to claim 2, characterized in that, said detection means (12) comprise at least one sensor of the optical type.

4. The machine (1) according to claim 2 or 3, characterized in that, said detection means (12) are arranged outside said safety chamber (18), below said bottom wall (7b).

5. Machine (1) according to claim 4, characterized in that, at least one portion of said bottom wall (7b) is made of a material transparent to light.

6. The machine (1) according to any one of claims 2 to 3, 5, characterized in that, said containing box (7) comprises conveying means (13) of said biological fluid, said conveying means (13) conveying said biological fluid to a collection seat (15) of said biological fluid accessible to said detection means (12).

7. The machine (1) according to claim 6, characterized in that, said conveying means (13) comprise at least one pair of inclined walls (14) resting inside said safety chamber (18) and converging towards said collection seat (15). 8) The machine (1) according to claim 7, characterized in that, said collection seat (15) defines a recess with respect to said inclined walls (14). 9) The machine (1) according to claim 7 or 8, characterized in that, said inclined walls (14) define said bottom wall (7b).

10. The machine (1) according to any of the preceding claims 1-3, 5, 7, 8, characterized in that, said containing box (7) is contained inside said carrier body (2) in said operating position and is arranged at least partially outside said carrier body (2) in said insertion / removal position.

11. The machine (1) according to any of the preceding claims 1-3, 5, 7, 8, characterized in that, said containing box (7) comprises at least one openable portion (10) to allow access to said containing space (8), said openable portion (10) being movable between an open configuration and a closed configuration with said containing box (7) in said insertion / removal position.

12. The machine (1) according to any of the preceding claims 1-3, 5, 7, 8, characterized in that, said irradiation means (4) are of the LED type.

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