CN219481063U - Device for forming a fluid circulation system and fluid circulation system - Google Patents

Abstract

An apparatus (3) for forming a fluid circulation system (1) comprises a supply line (4) with a first connecting element (5), a collecting vessel (8) connected to the supply line (4), a pump (11) for conveying fluid, an irradiation bag (10) connected to the collecting vessel (8) by means of a connecting line (9), and a discharge line (13) connected to the irradiation bag (10) with a second connecting element (14), wherein all components of the apparatus (3) are non-detachably connected to one another.

Description

Device for forming a fluid circulation system and fluid circulation system

Technical Field

The utility model relates to a device for forming a particularly sterile and closed fluid circulation system and to a fluid circulation system having such a device.

Background

In therapeutic apheresis (also known as blood washing or blood purification methods), the patient's blood, plasma or blood components are subjected to therapeutic treatment in the extracorporeal circulation, i.e. outside the patient's body, to remove pathogens or unwanted components such as proteins, protein-binding substances and cells. After removal of the substances or after treatment of the blood components, the treated blood, plasma or blood components are recycled. In order to form an extracorporeal circuit, different components are required, which must be manually connected to each other in situ in the treatment apparatus. If the components are improperly connected, damage and/or contamination may occur. There is a risk of: extracorporeal circulation is not performed aseptically. Non-sterile cycles cannot be used for therapeutic apheresis. If a non-sterile embodiment is not identified, this extracorporeal circulation constitutes an increased health risk. Light introduction devices are known from GB 2 439 144A and EP 3 693 036 A1.

Disclosure of Invention

The aim of the utility model is to reduce the health risks in the formation of a sterile fluid circulation system and in particular to reduce the costs in the formation of a particularly sterile and closed fluid circulation system.

According to an embodiment of the utility model, it has been realized that a fluid circulation system, in particular a sterile and closed fluid circulation system, may be formed by a device in which all components are non-detachably connected to each other. The device is embodied in one piece. The device itself is closed, sterile. The components of the device cannot be separated from each other without damage. The components of the device are sealingly connected to each other. The device itself is sterile. The device can be connected aseptically to a therapeutic instrument, in particular a apheresis-blood hose system, also called collection kit, wherein the device forms an especially additional, in particular closed, aseptic extracorporeal circulation with the therapeutic instrument. The device may be aseptically coupled to the therapeutic apparatus. The device forms part of a circulation system, wherein in particular the supply line of the device and the discharge line of the device can be coupled to the therapeutic device in such a way that a closed circulation system is produced.

Advantageously, the device is embodied with, in particular, an electronic encryption mechanism, which can be decrypted, i.e. activated, by means of a decryption mechanism. The decryption means are in particular electronic decryption means and are in particular implemented separately from the device, i.e. spatially separated. This ensures that only authorized devices can be connected to the therapeutic apparatus to form a fluid circulation system. The system as a whole is thus reliably and trouble-proof implemented.

In particular, a fluid circulation system is provided by means of the sterile connection of the device to the therapeutic apparatus, which forms a sterile closed unit and is particularly suitable for carrying out light introduction. Thus, it has been found in accordance with the present utility model that a therapeutic device, particularly a apheresis device, can be expanded by a device having a sterile closure unit. With the device according to the utility model, existing singles can be upgraded simply, cost-effectively and reliably with a sterile fluid circulation system. The device according to the utility model enables uncomplicated retrofitting of the single-sampling device and thus functional upgrades. Thus, the existing single-sampling instrument becomes an optical sampling instrument. The device may alternatively be connected to a blood collection device or a blood bag.

The device comprises a supply line by means of which fluid can be fed to the device. The supply line is embodied in particular as a hose line. The hose line is made in particular of a plastic material which is in particular biocompatible and is adapted in particular in terms of material and diameter to the hose of the apheresis blood hose system.

The hose line is made in particular of polyvinyl chloride (PVC). The other parts of the device are made in particular of plastic material, in particular of acrylic material, polypropylene (PP), polyamide (PA), ethylene-vinyl acetate copolymer (EVA), in particular polyethylene-vinyl acetate and/or acrylonitrile-butadiene-styrene copolymer (ABS).

In particular, all materials used for the device are plastic materials, which are in particular free of plasticizers, in particular free of phthalates, in particular free of diethylhexyl phthalate (DEHP).

The supply line has in particular an integrated filter element, in particular in the form of a gel filter.

The supply line comprises a first connecting element. The device can be connected to the therapeutic apparatus aseptically by means of the first connecting element. The first connecting element may be formed by a sterile end of the supply line, wherein the supply line may be connected to a corresponding line of the therapeutic device by welding by means of a sterile docking system, in particular a line welding device. The sterile end of the supply line is formed in such a way that the supply line is closed on the first connecting element, wherein the closure is embodied sterile on this end. Alternatively, the first connection element may be embodied as a mandrel for penetrating into a corresponding connection element of the therapeutic device. The first connection element may also be embodied as a luer lock connection.

The device has a collection container connected to the supply line. The collecting container is made of plastic material, in particular as a collecting bag. The plastic material is biocompatible. The collecting bag is made in particular of ethylene vinyl acetate copolymer (EVA), in particular of polyethylene vinyl acetate.

The collection bag has in particular a volume of 100ml to 1000 ml.

The treatment vessel is connected to the collection vessel by means of a connecting line. The treatment container is made of plastic material, in particular as a treatment bag. The processing bag is in particular made of the same plastic material from which the collecting container is made. The processing bag is capable of performing a process on a fluid. The treatment bag is embodied in particular as an irradiation bag. The irradiation bag is composed in particular of a plastic material which is transparent in the wavelength range from 100nm to 1000nm, in particular from 150nm to 900 nm. Transparent means that the material of the illumination bag has a transmittance T for light in the wavelength range of at least 30%, in particular at least 50%, in particular at least 70%, in particular at least 80%, in particular at least 90% and in particular at least 95%.

The illumination bag allows the fluid to be illuminated with light of different wavelengths. In particular, the fluid is guided in a meandering manner in the irradiation bag. In particular, the inner surface of the fluid flow channel in the illumination bag is embodied with a surface structure, in particular grooves. Thereby, micro-turbulence is created in the fluid when the bag is illuminated by the flow, thereby rotating particles in the fluid, in particular cells, in particular around the axis of the body itself. Thereby, particles in the fluid may be irradiated from different directions. In particular, it is conceivable that the particles make a complete, i.e. 360 ° rotation about their own axis. Thereby improving the irradiation result. This allows for a targeted and defined treatment of an increased amount of fluid in the treatment bag. In particular, blood with an increased hematocrit, i.e. with an increased proportion of erythrocytes in the blood volume, can advantageously be irradiated. In particular due to the increased number of erythrocytes and in particular avoiding the risk of particles in the fluid being obscured. Such an irradiation bag enables blood to be treated with different hematocrit, in particular in the range of 0% to 10% and in particular in the range of 1% to 6%. Such hematocrit is typical for pre-treated blood in which there is still a remaining portion of the red blood cells. The irradiation bag is also suitable for irradiating liquids containing impurities.

The apparatus also has a discharge line connected to the process vessel, the discharge line including a second connecting element. In particular, the outlet line has an integrated filter element in the form of a gel filter. By means of the second connecting element, the device can be connected aseptically to the corresponding element of the therapeutic apparatus and/or to the patient. The second connecting element may be implemented in correspondence with the first connecting element. The second connection element may also be embodied as a luer connection. The drain line is used to direct fluid delivered by the device back into the therapeutic device and/or back into the patient. The discharge line can be embodied like the supply line as a hose line made of plastic material.

The device according to the utility model is in particular a one-piece system which can be connected to a therapeutic apparatus by means of a first connection element and a second connection element. The risk of improper connection of the device components is precluded. There is no health risk. The device and therapeutic apparatus form a closed, sterile fluid circulation system.

The device is in particular a self-contained and in particular sterile kit which can be docked in a universal manner to a therapeutic device. The device can be adapted in particular universally to a therapeutic device and can be used in particular for an existing extracorporeal fluid circuit and for example for collecting body fluids, such as blood and blood components, in bags. With the device and the single-sampling apparatus according to the utility model, a fluid circulation system in the form of a single-sampling system can be formed. In particular, the apheresis system may be used as a photoperiod system for phototherapy. The device is especially manufactured as a hose system.

The device comprises a pump by means of which fluid can be transported in the device. In particular, the pump is arranged along the connecting line, i.e. in particular between the collecting vessel and the processing vessel.

According to one embodiment of the present application, a return line allows fluid processed in the processing vessel to return to the collection vessel. The fluid is recycled to the collection vessel. The collection vessel is also referred to as a recycling vessel or recycling bag. Different volumes of fluid can be provided in the processing vessel for processing.

According to one embodiment of the present application, the secondary supply line enables sterile supply of any type of liquid into the collection container. In particular, the secondary supply line has an integrated filter element with a pore size of at most 0.2 μm, in particular at most 0.1 μm and in particular at most 0.05 μm. The secondary supply line is connected in particular directly to the collecting vessel. At the end facing away from the collecting container, the secondary supply line can have a connecting element with which the secondary supply line can be connected aseptically to the source of the liquid to be supplied. A storage container, for example, of liquid, may be used as a source.

According to one embodiment of the present application, the irrigation line enables a direct, uncomplicated and reliable irrigation of the device, also known as irrigation, in particular with physiological irrigation solution. The flushing line can be connected aseptically to the source of flushing solution by means of a third connecting element, which is embodied in particular similarly to the first connecting element. In particular, a filter element, in particular a bacterial filter, is integrated in the flushing line, in particular having a pore size of up to 0.2 μm, in particular up to 0.1 μm and in particular up to 0.05 μm. The flushing line is connected to the connecting line, in particular by means of a Y-shaped connecting element.

According to one embodiment of the present application, the closing element simplifies the determination of the flushing direction in the device. In particular, the closing element is arranged upstream of the Y-shaped connecting element on the connecting line in the direction of fluid flow. The flow direction of the rinse solution is rectified with the fluid flow direction.

According to one embodiment of the present application, the control element is used for controlling and in particular for regulating the flow rate of fluid into the device, inside and/or out of the device.

According to one embodiment of the present application, means allow for backflow of the fluid from the collection container to the therapeutic device.

According to one embodiment of the present application, the sampling container enables a defined and less error prone sampling of the fluid. In particular, at least two sampling containers are provided, which are connected to the collection container. The fluid supply from the collection container into the respective sampling container can each be closed, in particular independently of one another, by means of a locking element, in particular in the form of a clamp. Separate samples of fluid may be taken before and after treatment. The sample extraction containers are in particular identically embodied and each have a volume that is smaller than the volume of the collection container. The sampling containers each have a volume, in particular of at least 5ml and in particular of at most 10ml. The sampling containers are in particular each embodied as a bag.

According to one embodiment of the present application, the device additionally reduces health risks.

According to one embodiment of the present application, the fluid circulation system is reliably implemented aseptically. The fluid circulation system with the device according to the utility model enables different applications. In particular, a single-use device is used as the therapeutic device. In particular, the fluid circulation system may be supplemented by an illumination unit for illuminating the illumination bag. Such a fluid circulation system may be used to perform optical mining.

A method for forming a closed, in particular sterile, fluid circulation system, comprising aseptically coupling the device to a therapeutic apparatus, in particular a apheresis apparatus, wherein the aseptic coupling is achieved by aseptically coupling a first connection element and a second connection element to the therapeutic apparatus and thereby forming a closed, sterile fluid circulation system, the method enabling an uncomplicated and reliable formation of the fluid circulation system.

Not only the features presented in the above-described embodiments but also those presented in the following embodiments of the device according to the utility model are each suitable for improving the subject matter according to the utility model, either alone or in combination with each other. The respective feature combinations do not constitute a limitation on the development of the subject matter of the utility model but are basically only exemplary features.

Drawings

Other features, advantages and details of the utility model will be apparent from the following description of embodiments thereof, which is to be read in connection with the accompanying drawings. Showing:

fig. 1 shows a schematic view of a fluid circulation system with a therapeutic apparatus and a device according to the utility model.

Detailed Description

The fluid circulation system, indicated as a whole with 1 in fig. 1, comprises a therapeutic apparatus 2, which according to the shown embodiment is implemented as a apheresis apparatus. The fluid circulation system 1 further comprises means 3 connected to the therapeutic apparatus 2, as schematically indicated in fig. 1 by a dashed box.

The device 3 comprises a supply line 4 embodied as a plastic hose, which is reliably and aseptically connected to a corresponding connection element, not shown, of the therapeutic apparatus 2 by means of a first connection element 5 embodied as a piercing mandrel according to the embodiment shown. A first filter element 6 in the form of a gel filter is arranged on the supply line 4. The first filter element 6 is optional, i.e. may be omitted.

Along the supply line 4 a first control element 7 is arranged. According to the embodiment shown, the first control element 7 is embodied as a variably adjustable clamp. The internal cross section of the supply line 4 and thus the throughflow rate of the fluid through the supply line 4 can be variably adjusted by means of the first control element.

The supply line 4 is connected to a collection container 8. The collection container 8 is embodied as a plastic bag. The collection container 8 is also called a collection bag.

The collecting bag 8 is connected to a treatment vessel 10 by means of a connecting line 9. Along the connecting line 9 a fluid pump 11 is arranged for conveying fluid in the fluid circulation system 1, in particular in the device 3. The connecting line 9 is made of plastic material as a hose line.

The treatment vessel 10 is embodied as a plastic bag. According to the exemplary embodiment shown, the treatment vessel 10 is embodied such that the fluid guided therein, in particular in a meandering manner, can be irradiated with light in the wavelength range from UV light to IR light by means of an irradiation unit, not shown. For this purpose, the treatment vessel 10 is composed of a material that is transparent in the wavelength range. The process vessel 10 is also referred to as an illumination bag.

The illumination bag 10 is connected to the collection bag 8 by a return line 12. According to the embodiment shown, the supply line 4 opens into the return line 12. However, it is also conceivable for the supply line 4 and the return line 12 to be each led separately into the collection bag 8. In particular, the supply line 4 and/or the return line 12 are arranged in the upper region of the collecting bag 8, so that the fluid automatically reaches downwards in the collecting bag 8 due to gravity and can be discharged via the connecting line 9 connected to the lower region of the collecting bag 8.

Also in the lower region of the collecting bag 8, a discharge line 13 is connected to the collecting bag 8. The discharge line 13 is connected to the irradiation bag 10 via the collecting bag 8 and the return line 12. The discharge line 13 has a second connection element 14, which according to the embodiment shown is embodied as a luer connection. By means of the second connecting element 14, the device 3 can be reliably and aseptically connected to a corresponding luer connection of the therapeutic device 2. Alternatively, the second connecting element 14 may also be connected directly to the patient via a cannula.

Along the outlet line 13, a second control element 15 is provided, which is in particular identical to the first control element 7.

Along the outlet line 13, a second filter element 16 is arranged in particular integrally. According to the embodiment shown, the second filter element 16 is implemented as a gel filter.

Along the outlet line 13, a fourth control element 32 is provided, which is in particular embodied identically to the first control element 7. The fourth control element 32 is arranged in particular in the fluid flow direction 31 between the second filter element 16 and the second connecting element 14. The fourth control element 32 is embodied in particular as a variably adjustable clamp. The fourth control element 32 is used to control the return flow, in particular the volumetric flow of fluid, from the device 3 to the therapeutic apparatus 2 and/or directly to the patient due to gravity. The fourth control element 32 can also be embodied as a pump, in particular as a regulated pump.

Two, in particular identically embodied sampling containers 17 are connected to the collection bag 8 via sampling lines 18. The sampling line 18 is embodied as a hose line made of plastic material. The sampling containers 17 are each embodied as a plastic bag having a volume of at least 5ml and at most 10ml. Along the sampling lines 18 branching off to the respective sampling vessel 17, locking elements 19 in the form of clamps are arranged in each case in order to lock or release the fluid flow from the collection vessel 8 into the respective sampling vessel 17.

The device 3 also has a flushing line 20, which is embodied as a hose line made of plastic material. The flushing line 20 is connected to the connecting line 9 by means of a Y-shaped connecting element 21. The flushing line 20 is used to flush the device 3 with a flushing solution. For this purpose, the flushing line 20 is connected to a flushing solution source 23 by means of a third connecting element 22. The source 23 of flushing solution is in particular a storage vessel in which the flushing solution is stored. The third connecting element 22 is embodied in particular in the form of a pierceable mandrel which is directly inserted into the irrigation solution source 23. By means of the connecting element, the flushing line 20 is connected aseptically to a flushing solution source 23.

Along the flushing line 20 a third filter element 24 in the form of a bacterial filter is arranged. The third filter element 24 is in particular a sterile filter. In particular, the bacterial filter is implemented integrated in the flushing line 20. Along the flushing line 20, a third control element 25 is arranged, which is embodied in particular identically to the first control element 7 and/or the second control element 15. The third control element 25 is arranged in particular on the flushing line 20 between the third filter element 24 and the Y-connection element 21.

A closing element 26 in the form of a clamp is arranged on the connecting line 9, and further a closing element 26 for closing off this connecting line 9 is arranged along the connecting line 9. The closing element 26 is arranged upstream of the Y-connection element 21 in the connection line 9 with respect to the fluid flow direction 31.

A secondary supply line 27 is connected to the collection bag 8, which secondary supply line is connected aseptically to a liquid source 29 by means of a fourth connecting element 28. Along the secondary supply line 27, a fourth filter element 30 is arranged, which is embodied in a particularly integrated manner. The fourth filter element 30 is embodied in particular as a sterile filter.

In particular, all lines of the device 3, in particular the supply line 4, the connection line 9, the return line 12, the discharge line 13, the sampling line 18, the flushing line 20 and/or the secondary supply line 27 are each embodied as a hose line made of plastic material. The plastic materials used are in particular biocompatible.

In particular, the containers used in the device 3, in particular the collection container 8, the irradiation bag 10 and/or the sampling container 17, are embodied as plastic bags.

In the device 3, all the components are fixedly and non-detachably connected to each other. Unintentional release of the components of the device 3 is precluded. The device 3 itself is implemented aseptically. The device 3 is sealed and can be connected aseptically to the external parts 2, 23, 29 by means of the connecting elements 5, 14, 22 and 28.

In particular, the first control element 7, the second control element 15, the third control element 25 and the closing element 26 are embodied as pure locking elements and are embodied in particular in the same way as the locking element 19. The locking elements 7, 15, 19, 25 and 26 are embodied in particular as locking clamps.

The function of the fluid circulation system 1 is explained in more detail below.

The patient's blood is provided by the therapeutic device 2 for treatment in the apparatus 3. Blood is supplied from the therapeutic device 2 via the supply line 4 to the collection bag 8. Blood passes from the collection bag 8 via the connecting line 9 into the irradiation bag 10.

The irradiation bag 10 is irradiated with light for example, to treat blood. The treated blood is returned from the irradiation bag 10 via the return line 12 into the collection bag 8 and, if necessary, is circulated for further treatment via the connection line 9 into the irradiation bag 10. The transport of blood within the device 3 is performed by means of a fluid pump 11.

After the treatment of the blood has been completed, the blood flows back from the collection bag 8 to the therapeutic device 2 via the outlet line 13. For this purpose, the controller 15 may be turned on. As long as blood does not flow back into the therapeutic apparatus 2, the discharge line 13 is closed off by means of the second control element 15.

In normal operation of the device 3, i.e. during the flow of blood through the device 3, in particular through the connecting line 9, the closure element 26 is opened, i.e. blood is allowed to flow through the connecting line 9.

When the device 3 is flushed, the closing element 26 is closed. For this purpose, the connection line 9 is supplied with a flushing solution from a flushing solution source 23 via a flushing line 20. The flushing solution can flow through all the components of the device 3.

The sampling vessels 17, which are implemented independently of one another, enable sampling, in particular before and after processing.

Liquid may be supplied to the collection vessel 8 from a liquid source 29 via a secondary supply line. In particular, the liquid is a photo-actuator, such as psoralen, verteporfin, vitamin B12, which adheres to the DNA of the collected blood cells. Additionally or alternatively, it is a liquid, such as an amino acid and/or an enzyme, which upon incubation with blood cells produces a natural light actuator, which is correspondingly attached to the DNA of the collected blood cells.

The method for forming the fluid circulation system with the device 3 and the meter 2 will be explained in more detail below.

First, the apparatus 3 is provided. The device 3 is a sterile system. The device 3 itself is not a circulatory system and is implemented as "open" in this regard. Open means that the device 3 has a supply line 4 and a discharge line 13. Since these lines 4, 14 can be coupled to the apheresis machine 2 via the connecting elements 5, 14 arranged thereon, respectively, a closed circulation system can be formed. The formation of a closed, sterile circulatory system is uncomplicated and can be independent of the respective therapeutic device. The device 3 ensures uncomplicated, reliable and flexible possibilities for creating a sterile fluid circulation. Furthermore, a single sampling apparatus 2 is provided. The self-closing and sterile device 3 is connected to the apheresis machine 2 in a sterile manner by means of the connecting elements 5, 14. The connecting elements 5, 14 are embodied aseptically. The risk of contamination of the coupling locations of the connecting elements 5, 14 to the monopulse meter 2 is precluded. Ensuring that the fluid circulation system itself is closed and sterile in itself.

Claims (10)

1. An apparatus for forming a fluid circulation system, the apparatus (3) comprising

A supply line (4) with a first connecting element (5),

a collection container (8) connected to the supply line (4),

a pump (11) for delivering said fluid,

an irradiation bag (10) connected to the collection container (8) by means of a connecting line (9), a discharge line (13) connected to the irradiation bag (10) having a second connecting element (14), wherein all components of the device (3) are non-detachably connected to one another.

2. The device according to claim 1, characterized in that the irradiation bag (10) is connected to the collecting container (8) by means of a return line (12).

3. Device according to claim 1, characterized in that a secondary supply line (27) is connected to the collecting container (8) via a fourth filter element (30).

4. Device according to claim 1, characterized in that there is a flushing line (20) connected to the connection line (9), which flushing line has a third connection element (22) which is connected to the flushing line (20) by means of a third filter element (24).

5. Device according to claim 1, characterized in that a closing element (26) for locking the connecting line (9) is arranged along the connecting line (9).

6. Device according to claim 4, characterized in that control elements (7, 15, 25, 42) for controlling the throughflow rate of the fluid are arranged on the supply line (4), on the discharge line (13) and/or on the flushing line (20), respectively.

7. The device according to claim 1, characterized in that the discharge line (13) is connected directly to the collecting container (8), in particular by means of a gel filter (16).

8. Device according to claim 1, characterized in that at least two sampling containers (17) are connected to the collection container (8).

9. The device according to claim 1, characterized in that the device (3) is closed aseptically.

10. A fluid circulation system comprising:

a therapeutic apparatus (2); and

the device (3) according to claim 1, being aseptically connected to the therapeutic apparatus.