Diaphragm pump

Abstract

A diaphragm pump for a biological process system includes a pump head including: a common inlet; a common exit; a plurality of pump chambers each including at least one pair of cooperating one-way valves, the at least one pair of one-way valves including an inlet valve and an outlet valve, where a respective inlet valve is in fluid communication with the common inlet and a respective outlet valve is in fluid communication with the common outlet, and where when the diaphragm pump is oriented for inhibiting trapped gas, the diaphragm pump is oriented for inhibiting trapped gas. The center of the outlet valve for each pump cavity can be positioned above the center of the inlet valve for the same pump cavity; and the plurality of movable diaphragms are respectively arranged in the respective pump cavities, so that the volume of the pump cavities is changed. The system further includes a pump drive configured to transfer motion to the diaphragm of the pump head as a result of said change in the volume of the pump cavity in order to complete fluid displacement from the common inlet to the common outlet of the pump head.

Description

Technical Field

[0001] The present invention relates to a diaphragm pump, a pump head for a diaphragm pump, a single-use flow path assembly for a bioprocess system, a one-way valve configured for use in a diaphragm pump, a movable diaphragm (13) configured for use in a diaphragm pump, a quick-connect fastener configured for use in a diaphragm pump, and a bioprocess system. Background Art

[0002] Fluid transfer in bioprocessing, such as that performed by instruments and systems for transferring and processing fluids in cell culture, separation, purification, filling, sampling, and analysis, requires a wide range of flow rates with precise control of volume accuracy and fluid pressure. Many applications and processing steps also require minimal fluctuations in flow and / or pressure. Positive displacement pumps typically provide a flow range required for bioprocessing, but at the expense of pressure pulsations at their output. Rotary element pumps provide generally consistent pressures, but their flow range is limited, and in the absence of multiple pump stages, it is difficult to achieve high pressures, and they may adversely affect drugs. It is known to work together to equalize multiple pumps of pressure pulses, but in order to achieve lower costs and to achieve minimized hold-up volume in the process, a single pump would be more ideal. Moreover, a single pump would be easier to control, maintain, and keep clean, especially for sanitation, sterilization, or aseptic processing. A single pump is also preferred for single-use processing equipment, in which components in fluid contact are replaced after use to eliminate the need and risk of equipment cleaning.

[0003] Diaphragm pumps have certain advantages in use in the field of bioprocessing, for example, diaphragm pumps do not impose high shear forces on the fluid being pumped, which is preferred for pumping fluids containing, for example, cells, proteins and viruses. Such pumps also have reasonable flow rates and pressure ranges. Multi-chamber diaphragm pumps have been proposed, for example as commercially available under the brand name Quattroflow TM, in which parallel chambers are driven by an inclined plate. A problem in some pumps can be air trapping.

[0004] In US20180142684, a multi-chamber diaphragm pump is described, and the problem of discharge and emission is discussed and attempted to be solved. In the device, the outlet opening of the outlet valve surrounds the inlet opening of the inlet valve, or vice versa. For example, some outlet openings are located at a high position of the chamber to support discharge, and other outlet openings are located at a low position to support discharge. However, all these outlet openings are covered by the same check valve. Thus, different outlet openings are opened and closed so that discharge and emission cannot be controlled separately. It is not guaranteed that the upper part of the valve is opened, especially at low flow rates. At low flow rates, only part of the valve will open, and if this is the lower part of the valve, air will not escape properly. Thus, a high flow rate may be required to ensure the discharge of the pump. Summary of the invention

[0005] It is an object of the present invention to provide an improved diaphragm pump.

[0006] A further object of the present invention is to provide a diaphragm pump having a reduced tendency to entrap air.

[0007] A further object of the invention is to provide a pump with low pulsation.

[0008] This is achieved by a diaphragm pump, a pump head, a single-use flow path assembly for a bioprocess system and a bioprocess system according to the independent claims.

[0009] According to one aspect of the present invention, there is provided a diaphragm pump, the diaphragm pump comprising: - A pump head comprising: Public entrance; Public exits; a plurality of pump chambers each comprising at least one pair of cooperating one-way valves, the at least one pair comprising an inlet valve and an outlet valve, wherein the respective inlet valves are in fluid communication with a common inlet and the respective outlet valves are in fluid communication with a common outlet, and wherein the center of the outlet valve for each pump chamber is positionable above the center of the inlet valve for the same pump chamber when the diaphragm pump is oriented for inhibiting trapped gas; and a movable diaphragm disposed in the pump chamber to vary the volume of the pump chamber; - A pump drive configured to transfer movement to the diaphragm of the pump head as a result of said change in volume of the pump chamber so as to accomplish the displacement of fluid from the common inlet to the common outlet of the pump head.

[0010] According to another aspect of the present invention, there is provided a pump head configured to be connected to a pump drive of a diaphragm pump, the pump head comprising: - Public entrance; - Public exits; a plurality of pump chambers each comprising at least one pair of cooperating one-way valves, the at least one pair comprising an inlet valve and an outlet valve, wherein the respective inlet valves are in fluid communication with a common inlet and the respective outlet valves are in fluid communication with a common outlet, and wherein the center of the outlet valve for each pump chamber is positionable above the center of the inlet valve for the same pump chamber when the diaphragm pump is oriented for inhibiting trapped gas; and - A movable diaphragm arranged in the pump chamber so as to vary the volume of the pump chamber.

[0011] According to another aspect of the present invention, there is provided a single-use flow path assembly for a bioprocess system, the single-use flow path assembly comprising a pump head as described above connected to the single-use flow path.

[0012] According to another aspect of the present invention, a bioprocess system is provided. The bioprocess system comprises the diaphragm pump as described above.

[0013] Hereby, a diaphragm pump is provided which has high accuracy and linearity and which can also be completely purged at low flow rates. By providing an outlet valve above the inlet valve in each pump chamber, air will not be trapped inside the pump. Hereby, sterilization is greatly improved, since all internal surfaces in the pump chamber are completely wetted, even when using low flow rates and low back pressures.

[0014] Furthermore, a diaphragm pump suitable for single-use applications is provided. Furthermore, a cost-effective and scalable diaphragm pump is achieved.

[0015] In one embodiment of the invention, the inlet valve and the outlet valve comprise flexible valve discs, each disc comprising a substantially central retaining stem for holding the valve disc in place.

[0016] In one embodiment of the invention, the pump head further comprises pivot means provided to the centre of the diaphragm engagement plate of the pump head so as to provide a pivot point to the centre of the diaphragm engagement plate. Thereby, it is ensured that the diaphragm engagement plate engaging the diaphragm of the pump head will always pivot about its centre and, thereby, the diaphragm will effectively be both pushed and retracted and, thereby, complete filling of the pump chamber can be provided even at high motor frequencies and when the fluid inlet pressure is low, for example when the fluid source is placed at a low position relative to the pump.

[0017] In one embodiment of the invention, the pump head further comprises at least one leakage collector, which is a flexible bellows surrounding the pump chamber and the diaphragm and configured to collect possible leakage from the pump chamber.

[0018] Further embodiments are described in the detailed description and in the dependent claims.

[0019] However, the present invention extends to any combination of features disclosed herein, whether or not such a combination is explicitly described or claimed herein. Moreover, where two or more features are mentioned in combination herein, it is intended that such features may be claimed separately without extending the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention can be implemented in many ways, illustrative embodiments of the invention are described below with reference to the accompanying drawings, in which: Figure 1a is a perspective view of a pump head according to one embodiment of the present invention; Figure 1b A pump head according to another embodiment of the invention has five chambers instead of three.

[0021] Figure 2 is an exploded view of a pump head according to one embodiment of the present invention; Figure 3a is an exploded view of the pump head as shown in FIG1 ; Figure 3b Showing a leakage collector according to one embodiment of the present invention; Figure 4 is an exploded view of a pump head according to another embodiment of the present invention; Figure 5a and Figure 5b are top view cross sections at different planes of a pump head according to one embodiment of the present invention.

[0022] Figure 6 is a side view cross section in part of a pump head according to one embodiment of the present invention showing the flow in the pump head.

[0023] Figure 7a is a side view cross section of a portion of a pump head according to one embodiment of the present invention.

[0024] Figure 7b is a side view cross section of a pump head according to one embodiment of the present invention.

[0025] Figure 8a and Figure 8b A cross-sectional view showing a pump head according to one embodiment of the present invention.

[0026] Figure 9a and Figure 9b The pump drive is shown in perspective and in cross section.

[0027] Fig.10a A graph showing outlet traffic.

[0028] Fig.10b Diagram showing pump drive compensation.

[0029] Fig.11 is a perspective view of a pump head according to one embodiment of the present invention.

[0030] Fig.12a An exemplary embodiment of an inlet valve or an outlet valve of a pump head is depicted in side view.

[0031] Figure 12b Depicted in partial cross-sectional side view Fig.12a Inlet valve or outlet valve in.

[0032] Fig.13 Depicts the pump chamber inlet valve or outlet valve area in a top view.

[0033] Fig.14 is an enlarged cross-sectional view of the sealing area of ​​an inlet channel or an outlet channel.

[0034] Fig.15 A cross-sectional view depicting an alternative exemplary embodiment of an inlet valve or an outlet valve of a pump head.

[0035] Fig.16 A further alternative exemplary embodiment of an inlet valve or an outlet valve of a pump head is depicted.

[0036] Figures 17a-17d A first exemplary embodiment of a quick-connect fastener for removably fastening a pump head to a pump driver is depicted in various views.

[0037] Figures 18a-18f A second exemplary embodiment of a quick-connect fastener for removably fastening a pump head to a pump driver is depicted in various views.

[0038] Figures 19a-19h A third exemplary embodiment of a quick-connect fastener for removably fastening a pump head to a pump driver is depicted in various views.

[0039] Figure 20a-20h A fourth exemplary embodiment of a quick-connect fastener for removably fastening a pump head to a pump driver is depicted in various views.

[0040] Figures 21a-21g A fifth exemplary embodiment of a quick-connect fastener for removably fastening a pump head to a pump driver is depicted in various views. DETAILED DESCRIPTION

[0041] The invention together with its objects and advantages may be better understood by referring to the following description taken in conjunction with the accompanying drawings.

[0042] Several different embodiments of the present invention are shown in the drawings, however, corresponding components are named and numbered identically. For example, Figure 2 , Figure 3a as well as Figure 4 Different embodiments of a pump head 1 ; 101 ; 201 according to the invention are shown, but corresponding individual parts will be given the same reference numerals and some of the details shown in other figures may be valid for more than one of the different embodiments.

[0043] Figure 2 , Figure 3a as well as Figure 4 This is an exploded view of pump head 1; 101; 201. Figure 2 and Figure 3a The pump head 1; 101 is configured to be assembled by a welding method (such as, suitably, diffusion bonding), i.e. the parts are made of a suitable plastic and they are compressed and heated to bond to each other. The diffusion bonding production method will avoid the use of screws and seals. However, another welding method may also be used, or the parts may alternatively be riveted together. Figure 4 In FIG. 2 , another embodiment of a pump head 201 is shown. The pump head is configured to be assembled by screws. However, most of the parts are the same as those of FIG. Figure 2 and Figure 3a The parts of the pump head 1; 101 shown in are the same or correspond.

[0044] Figure 1a is Figure 3a A perspective view of the assembled pump head 101 is shown in FIG. Figure 1b It is a pump head 301 having five chambers 7 instead of three. Figure 5a and Figure 5b As shown in Figure 1 and Figure 3a The top view cross section of the pump head 101 shown in FIG. 1 is shown in FIG. 1 , but the design in this view is for Figure 2 , Figure 3a as well as Figure 4 All embodiments shown in are similar. Figure 6 Yes Figure 4 201, but the design is similar to that for Figure 2 and Figure 3a The pump head shown in is also very similar. Figure 7a and Figure 7b is a side cross-section of the pump head 101', 101", the pump head 101', 101" and Figure 3a The pump head shown in is similar but has additional outer parts 161 , 161 ' for connecting the inlet and outlet. Figure 8a and Figure 8bShows detail of a pivot point which may be provided in all embodiments of the invention.

[0045] Figure 9 shows a pump drive 31 according to one embodiment of the invention. The invention will now be described with reference to all of the accompanying drawings.

[0046] The present invention relates to a diaphragm pump, which comprises a pump head 1; 101; 201 and a pump drive 31. The present invention further relates to a pump head 1; 101; 201 configured for connection to the pump drive 31 of the diaphragm pump. The pump head comprises a common inlet 3, a common outlet 5 and a plurality of pump chambers 7. Each pump chamber 7 comprises at least one pair of cooperating one-way valves, wherein the at least one pair of one-way valves comprises an inlet valve 9 and an outlet valve 11. The respective inlet valve 9 is in fluid communication with the common inlet 3, and the respective outlet valve 11 is in fluid communication with the common outlet 5. According to the present invention, when the diaphragm pump is oriented for suppressing trapped gas, the center of the outlet valve 11 for each pump chamber 7 can be positioned above the center of the inlet valve 9 for the same pump chamber 7. When the outlet valve 11 is arranged above the inlet valve 9 in each chamber 7, air will be effectively transported out of the pump head instead of being trapped. By providing one inlet valve 9 and one outlet valve 11 for each cavity and arranging them in position so that for each cavity the center of the outlet valve 11 can be located above the center of the inlet valve 9 provided for the same cavity, air can be effectively purged and the problem of trapped air can be avoided. Depending on the design and performance of the valve, the positioning of the outlet valve relative to the inlet valve in each cavity may be slightly different. The positioning does not necessarily have to be the center of the outlet valve positioned above the center of the inlet valve in all cases. Rather, the positioning will be the flow center of the outlet valve which should be positioned above the flow center of the inlet valve.

[0047] Furthermore, the pump head 1; 101; 201 comprises a movable diaphragm 13 arranged in said pump chamber 7 for causing a change in the volume of the pump chamber. Due to said change in the volume of the pump chamber 7, the drive 31 of the diaphragm pump is configured to transfer movement to the diaphragm 13 of the pump head 1; 101; 201 so as to achieve a fluid displacement from the common inlet 3 to the common outlet 5 of the pump head 1; 101; 201.

[0048] The inlet valve 9 and the outlet valve 11 may comprise flexible valve discs 9a, 11a, each disc comprising a substantially central retaining rod 9b, 11b for holding the valve discs 9a, 11a in place. The flexible valve discs 9a, 11a may have a crescent shape in cross section, or the flexible valve discs 9a, 11a may alternatively be flat. Such valves may be referred to as umbrella valves and are suitable because they are symmetrical and can be used in an optimal space-saving manner. They can also be easily optimized for different pressures and sealing requirements. Possible materials for the valve are, for example, TPE, silicon and EPDM. A duck valve is an example of another type of valve that can be used. The material of the valve and the size and design of the valve should be selected so that the opening pressure and closing pressure for the valve are as small as possible. Fig.12a An exemplary embodiment of an inlet valve 9 or outlet valve 11 is depicted in a side view. The inlet valve 9 or outlet valve 11 comprises a central retaining stem 9b, 11b, a flexible valve disc 9a, 11a, an outer sealing area 9c, 11c and a valve stem sealing area 9d, 11d. Fig.13 The pump chamber inlet or outlet valve area 90 is depicted in a top view. The pump chamber inlet or outlet valve area 90 includes a central hole 66 for holding and guiding the inlet center retaining rod 9b or the outlet center retaining rod 11b. The central hole 66 is not configured for fluid delivery. The pump chamber inlet or outlet valve area 90 further includes eight inlet channels 61a or outlet channels 61b, a valve seat 90c, and a valve sealing surface 90d. Fig.13 In the embodiment, eight inlet channels or outlet channels are used, in various exemplary embodiments, the number of channels may be higher or lower, for example, 2, 4, 5, 6, 10, 12 or 15. The inlet channels 61a or outlet channels 61b may have the same or different diameters.

[0049] The outer sealing area 9c, 11c of the inlet valve 9 or outlet valve 11 is configured to seal against the valve seat 90c. The valve stem sealing area 9d, 11d is configured to seal against the valve sealing surface 90d. In the closed valve position, the outer sealing area 9c, 11c of the inlet or outlet valve is in contact with the valve seat 90c. In the closed valve position, the valve stem sealing area 9d, 11d is in contact with the valve sealing surface 90d. Fig.14 is an enlarged cross-sectional view of a sealing area of ​​one of the inlet channel 61a or the outlet channel 61b. Fig.14 , the valves 9, 11 are in their closed positions, i.e., the outer sealing area 9c, 11c of the inlet valve 9 or the outlet valve 11 is in contact with the valve seat 90c, and the valve stem sealing area 9d, 11d is in contact with the valve sealing surface 90d.

[0050] In the closed valve position, a predetermined force can be applied to the central retaining rod 9b, 11b in order to ensure a liquid-tight closed position. In the open valve position for the inlet valve 9, the flexible valve disc 9a is deformed by the suction force from the diaphragm 13 and the liquid flow from the inlet channel 61a. In the open valve position for the outlet valve 11, the flexible valve disc 11a is deformed by the liquid flow from the outlet channel 61b. In the open valve position, the outer sealing area 9c, 11c of the inlet valve or outlet valve is at least partially not in contact with the valve seat 90c. In the open valve position, the valve stem sealing area 9d, 11d is still in contact with the valve sealing surface 90d in order to ensure that liquid does not pass through the central hole 66. The opening of the inlet valve 9 or the outlet valve 11 is performed by deforming the outer sealing area 9c, 11c so that the seal with the valve seat 90c is broken.

[0051] In various exemplary embodiments, the inlet valve 9 or outlet valve 11 is made of a homogeneous single flexible material. In various exemplary embodiments, at least the outer sealing area 9c, 11c of the inlet valve 9 or outlet valve 11 is made of a first material, while the core of the valve may be made of a second material. The first material in the outer sealing area 9c, 11c may be more flexible than the second material in the core of the valve 9, 11.

[0052] Figure 12b An exemplary embodiment of an inlet valve 9 or an outlet valve 11 is depicted in a partial cross-sectional side view, the inlet valve 9 or the outlet valve 11 having a core 9', 11' made of a first material and an outer layer 9", 11". made of a second material. The second material is more flexible / softer than the first material. The outer layer 9", 11" comprises the outer sealing area 9c, 11c of the flexible valve disc 9a, 11a, which is configured to at least partially seal against a corresponding valve seat 90c in the pump head 1; 101; 201; 301. Compared to the solutions of the prior art, the suitable flexibility of the second material will provide both improved sealing properties and improved lifespan.

[0053] In various exemplary embodiments, the inlet valve 9 and the outlet valve 11 may further include the first softer material in valve stem sealing areas 9d, 11d configured to seal against at least part of a corresponding valve sealing surface 90d in the pump head 1; 101; 201; 301. In various exemplary embodiments, the valve sealing surface 90d and / or the valve seat 90c may also be made of the second material.

[0054] In various exemplary embodiments, the softer material in the outer sealing area 9c, 11c of the flexible valve disc 9a, 11a and / or the valve stem sealing area 9d, 11d of the valve 9, 11 may be applied as the layer 9", 11" having a predetermined thickness to the core 9', 11' having the second material. Fig.15 A cross-sectional view of an inlet valve 9 or an outlet valve 11 is depicted, the inlet valve 9 or the outlet valve 11 having the core 9', 11' made of the first material and the outer layer 9", 11" made of the second material. The core may form a flexible disk 9a, 11a and part of the center retaining rod 9b, 11b. At least a portion of the center retaining rod 9b, 11b may have a truncated conical shape. The truncated conical shape of the center retaining rod 9b, 11b may improve the life of the valve 9, 11 because it reduces wear and friction on the center retaining rod 9b, 11b when it is sliding in the center hole 66 of the pump chamber.

[0055] Fig.16 An alternative exemplary embodiment of an inlet valve 9 or an outlet valve 11 made of the first and second materials is depicted. Fig.16 In the embodiment, the central holding rod 9b, 11b is made of the first material, and the flexible valve disc 9a, 11a is made of the second material. Fig.16 In the embodiment, the core 9', 11' made of the first material is only partially covered by the outer layer 9", 11". Fig.16 In the embodiment, the outer sealing areas 9c, 11c of the flexible valve discs 9a, 11a are made of the second material, and the valve stem sealing areas 9d, 11d are made of the first material.

[0056] In such Figure 1a and Figure 2 In the embodiment shown in FIG. 8 , all three pump chambers 7 are arranged to be in fluid communication with the common inlet 3 via respective pump chamber inlets 126. Figure 1b The embodiment shown in the embodiment includes five pump chambers 7, but in other cases, it is similar to other embodiments and will not be described in more detail. Each pump chamber inlet 126 includes a one-way inlet valve 9, which allows fluid to flow into the pump chamber 7, but not to flow out of the pump chamber 7. Each pump chamber 7 is further fluidly connected to the common outlet 5 via a pump chamber outlet 130. Each pump chamber outlet 130 includes a one-way outlet valve 11, which allows fluid to come out of the pump chamber 7, but not into the pump chamber 7. In another embodiment, multiple one-way inlet valves and / or multiple one-way outlet valves are provided.

[0057] Each pump chamber 7 further comprises a flexible material diaphragm 13 which can be moved in the direction of arrow R (in FIG. 9 ) by a drive means 35 (shown as an example of a wobble plate). Figure 6 7 ) moves in a reciprocating motion. The drive device may be, for example, a mechanical device connected to a mechanical interface. Examples of other types of drive devices include pneumatic pressure fluctuations, hydraulic pressure fluctuations, or mechanical movement from a motor or electric solenoid, etc.

[0058] In this embodiment, each pump chamber inlet 126 includes a plurality of inlet passages 61a arranged around a circle. Also, in this embodiment, the pump chamber outlet 130 includes a plurality of outlet passages 61b arranged around a circle. This can be Figure 5a and Figure 5b . The plurality of inlet channels 61a for each of the cavities 7 are all closed by a corresponding one-way inlet valve 9, in this case in the form of a simple elastomeric cup which flexes to allow fluid to enter the cavity 7 but is pushed onto the inlet channel 61a by fluid pressure to close the inlet channel 61a to prevent fluid from escaping via the inlet channel 61a. The outlet valve 11 is similar in structure to the inlet valve 9 and allows fluid to exit rather than return to the cavity 7. In this embodiment, the flexible diaphragm 13 comprises a disc-shaped moulding formed of an elastomeric material. Figure 6 One of the chambers 7 is shown having a plurality of inlet channels 61a (a central hole for holding the inlet valve retaining stem 9b and not used for fluid transport) and a plurality of fluid outlet channels 61b having a central hole for the outlet valve retaining stem 11b.

[0059] The pump head 1; 101; 201, 301 may further comprise a pivot device 25, which is arranged to the center C of the diaphragm engaging plate 27 of the pump head 1; 101; 201; 301 so as to provide a central pivot point to the diaphragm engaging plate 27, about which the diaphragm engaging plate 27 can be tilted. This can be Figure 8a and Figure 8b201 will always pivot about its centre C and, thereby, the diaphragm 13 will effectively be both pushed and retracted and, thereby, complete filling of the pump chamber 7 can be provided even at high motor frequencies and when the fluid inlet pressure is low, for example when the fluid source is placed at a low position relative to the pump. The pivoting means 25 can, for example, be a rubber element that can be squeezed into the opening 26 in the diaphragm engaging plate 27. A recess 28a is provided in the diaphragm retaining plate 28, whereby the recess 28a receives a first end 25a of the pivoting means 25 that protrudes outwardly from the diaphragm engaging plate 27, whereby the pivoting means 25 is designed so as to provide a distance between the diaphragm engaging plate 27 and the diaphragm retaining plate 28. An alternative to the pivoting device 25 is to connect the wobble plate 25 and the diaphragm engagement plate 27, for example, by mechanical fixing (such as clamping), by bayonet or by magnetic force. Automated features may be provided to accomplish the mechanical or magnetic fixing, such as motorized locking or electromagnetic locking and / or utilizing reverse pump drive rotation.

[0060] The pump head 1; 101; 201 may further include a leakage collector 21; 121, which is a flexible bellows surrounding the pump chamber 7 and the diaphragm 13 and configured to collect possible leakage from the pump chamber 7. Figure 3a and Figure 3b 121 is shown in FIG. Two or more leakage collectors may surround individual pump chambers and diaphragms, however, for reasons of cost and simplicity, preferably a single leakage collector 21; 121 is used to collect possible leakage from all pump chambers 7. The leakage collector 21 may be an elastic bellows which may be made of a highly flexible elastomer. As may be seen in FIG. Figure 3a As seen in FIG. 1 , the leakage collector 21 may be provided between the diaphragm engaging plate 27 and the diaphragm retaining plate 28 of the pump head. Figure 4In the embodiment of the invention shown in , a leakage collector 21 may also be provided which is assembled by screws rather than diffusion bonding. The leakage collector 21; 121 should be sealed against both the diaphragm engaging plate 27 and the diaphragm retaining plate 28. A leakage sensor (for example, a conductivity sensor or a total reflection prism for optical detection such as in a dishwasher or a dynamometer) may be applied to the lower end of the leakage collector 21; 121 to detect leakage. Alternatively, a change in pump flow at a given pump speed may be interpreted as a failure of one pump chamber. When using the leakage collector 21; 121 according to the present invention, the diaphragm 13 may be fully optimized to achieve optimal hardness to accomplish pumping tasks over a wide range, rather than compromising, for example, by adding an auxiliary layer to the diaphragm for leakage protection as in some prior art products. Leakage collector The collector 21; 121 may also be clean and pre-sterilized, so any process fluid collected by the leak collector 21; 121 may be recovered without contamination. Furthermore, by using the leak collector 21; 121 according to the present invention, no fluid is exposed outside the closed process line of the system, so there is no risk of exposure to harmful substances such as viruses for the operator. When a possible leak is contained within the single-use flow path (pump), decontamination of the room is not required. The discharge path may be provided, for example, in the diaphragm retaining plate 28, and a sensor may be provided there.

[0061] exist Figure 3b , a leakage collector 121 according to another embodiment of the present invention is shown. Such a leakage collector 121 can be used in all different pump heads 1; 101; 201; 301 as described according to the present invention. In this embodiment, the leakage collector 121 includes a bottom discharge port 123, which can optionally be provided with a sterilization connector. In the event of fluid leakage from the pump chamber into the leakage collector, the bottom discharge port 123 can be used to discharge and recover valuable or alternatively dangerous process fluid. The leakage collector 121 is cleaned and sterilized in the same way as the rest of the pump head, and, thereby, any possible fluid leakage can be recovered. A second port 125 can also be provided to the leakage collector 121, which second port 125 can be a discharge port to allow the leakage collector 121 to be discharged. When the pump head is assembled to the pump drive, the second port can be appropriately positioned at the top position of the leakage collector 121. The second port 125 may be located on an opposite side of the leakage collector 121 compared to where the exhaust port 123 is located. The second port 125 may be provided with a sterile air filter that may be connected to a pre-fitted sterile connector.

[0062] exist Figure 9a and Figure 9b2 shows a pump drive 31 according to one embodiment of the invention. The pump drive 31 may include a rotating drive shaft 33 and a wobble plate 35, which is connected obliquely to the drive shaft 33 via a bearing 37. The wobble plate 35 is configured for connection to the pump head 1; 101; 201 so as to transfer movement from the rotating drive shaft 33 to the diaphragm 13. As a result of the rotation of the drive shaft 33 about its longitudinal axis and due to the oblique connection via a bearing (e.g., a roller bearing), the wobble plate 35 is enabled to perform a circumferential rocking motion without rotating with the drive shaft 33. This circumferential rocking motion is converted into a movement of the diaphragm 13 and thereby a pumping action. The inclination of the wobble plate 35 relative to the drive shaft 33 can be varied, which will vary the maximum pump flow rate and the minimum pump flow rate of the pump. The tilt angle can also be adjusted in a dynamic manner, so that the angle and thus the pump stroke can be adjusted during operation of the pump without removing or replacing parts and even within or between different processing operations and process steps.

[0063] In some embodiments of the invention, the pump drive 31 may be configured to apply active modulation of the pump speed to the rotation of the drive shaft 33 in order to compensate for pump pulsations. If three pump chambers are provided distributed radially around the center C of the pump head 1; 101; 201, the drive shaft may be controlled to increase the speed of the drive shaft by, for example, approximately 15% for every 120 degrees to compensate for a temporary drop in flow rate between two discharge events as the drive shaft is sweeping through certain angular positions of the drive shaft. Fig.10a The flow rate as a function of the angular position A2 for the drive shaft is shown, i.e. the uncompensated outlet flow rate from a diaphragm pump according to the invention (i.e. for a constant angular velocity A2 of the drive shaft), which comprises three chambers 7 and three diaphragms 13. The flow rate from each of the chambers is denoted F1, F2 and F3 respectively, and the sum of the flows is given in Fig.10a The flow rate can be compensated by adjusting the angular velocity of A2 as a function of the angular position of A2. The velocity modulation is 1 / (F1+F2+F3), which is Fig.10b Displayed in. Fig.10b is a graph showing the modulation of the motor speed as a function of angular position. Compensation may be beneficial only at low angular velocities where the pulsation will have the greatest effect. In some embodiments of the invention, active modulation of the pump speed may also be provided dynamically using a pressure sensor and the average motor speed is controlled in addition to a fixed modulation. A motor with position control, such as a stepper motor, may be suitably used for this embodiment so that the angular position of the drive shaft relative to the pump head can be recorded.

[0064] The pump head 1; 101; 201 according to the invention may suitably comprise three or five pump chambers 7 radially distributed around the centre C of the pump head 1; 101; 201. Thereby, due to the advantageous addition of a sinusoidal curve in the discharge action, the pulsation is significantly reduced compared to, for example, a four-chamber design. The low pulsation is particularly advantageous for low flow rates and low rpm. This low pulsation allows the pump to be used in a wide operating range. Pulsation-free operation allows for better, more stable and robust process control at low flow rates. If active modulation as described above is also used, the pulsation is further reduced.

[0065] The diaphragm engaging plate 27 of the pump head 1; 101; 201 and the wobble plate 35 of the pump drive 31 may include cooperating connection features 41a, 41b, which are provided to avoid any rotation and friction between the wobble plate 35 and the diaphragm engaging plate 27. Thereby, wear of components due to friction may be avoided.

[0066] For a single-use pump head, the assembly of the pump head to the instrument should preferably not require the use of any additional tools. Thus, a simple assembly of the pump head to the pump driver is provided, which is particularly advantageous for a single-use pump head. The connection between the pump head and the pump driver may additionally include an engagement lever and / or an automated solution that may be driven by a motor, pneumatic device or magnetic device. A circular locking mechanism may also be provided between the pump head and the pump driver.

[0067] Especially for single-use pump heads where frequent attachment and detachment of the pump head relative to the pump drive is required to assemble and remove flow paths and consumables, a safe, efficient and user-friendly assembly procedure is critical to the efficiency, quality and robustness of bioprocessing operations.

[0068] The assembly procedure for the pump head may involve positioning, alignment and / or attachment of the pump head to the instrument, and / or the pump drive may involve controlled actions for movement or rotation of parts relative to each other, clamping or locking of components. These actions may be performed manually by an operator, or these actions may be partially or completely automated. The procedure may involve multiple steps, some of which may be performed manually, and other steps may be performed by automation. For example, manual steps and / or automated steps may be assisted by motors, (electro) magnets or pneumatic devices. Corresponding features may also assist in dismantling and removing the pump head from the drive.

[0069] In certain embodiments, the steps involved in the assembly and / or removal of the pump head can be monitored and promoted by sensors and / or indicators that display status information to the user. For example, the sensor can detect whether the pump head is in the correct position during one or several periods in the step. The sensor can also monitor and confirm that the pump head is in the correct position before, during and / or after the operation of the bioprocessing system. In one embodiment, a counter is provided so as to track the use of the pump head, for example, by counting the number of revolutions or the number of pump strokes. The counter can be provided mechanically or electronically by a feature positioned in the pump head or positioned at the pump head, but information can also be provided by a control system and an instrument, so that, for example, an RFID tag at the pump head can be rewritten, thus providing the latest information about the pump head, the state of the pump head, the use and / or the use history of the pump head.

[0070] In another embodiment of the invention, the pump head is provided with an indicator that displays status information for the pump (e.g., indicating the pump running status, correct operation, idle state, flow rate or pressure information, information about air entrapment, etc.). The information can be displayed qualitatively, for example, by changing the color, intensity or flashing frequency of a light (e.g., an LED or display). In another embodiment, the light intensity and / or color of the lightning changes, and / or the characteristics or frequency of the lightning enhancement changes, depending on the pump operation, operating parameters or other parameters of the pump or system.

[0071] Alternatively, the information may be quantitatively displayed by displaying digital characters on a display surface which digitally displays, for example, the current flow rate or pressure. Such a display surface may, for example, be suitably positioned on a pump head plate facing the user. The pump head 101 ' comprising the display 102 is located on Fig.11 However, in this example, the display 102 is provided on a side surface of the pump head 101 '.

[0072] In one embodiment, a display made of an LCD or the like is provided. In another embodiment, an eINK (electronic ink) display is provided, which allows information to be retained on the display even when there is no power supplied to the display, thereby allowing current information and related information about the pump and / or pump head to be displayed when the unit is not in use, not assembled or not connected to a power source. Thus, single-use pump head consumables can also display the latest information during storage, transportation, before use or after use, so that the user can easily identify the status of the consumables. An eINK display with color display capability can be provided to supply the previously mentioned information both during processing and during pre-processing and post-processing, such as, in storage, assembly, removal, disposal, recycling, etc.

[0073] In one embodiment, the display and or eINK display can display up-to-date information about the pump head, the status, use and / or use history of the pump head before and after use and installation with the instrument and system. The information display can also display graphical information such as icons, arrows, graphics, etc. The displayed information can guide the user during the installation process and assembly process, for which purpose the display can be driven by an internal battery or by an energy harvesting device. The information can be transmitted wirelessly to the pump head display or other local indicator means, for example, the previously mentioned status light indicator.

[0074] In another embodiment, the pump and / or pump head supports asset performance management (APM) by communicating and / or displaying information about status, function, history, wear and tear, service interactions, etc., to allow, for example, improved monitoring, analysis, and predictive, planning, and improved workflows. Sensors may be provided to support a range of asset performance management.

[0075] In another embodiment of the present invention, the pump head is provided with a sensor for monitoring the properties of the process fluid (such as pressure, conductivity, pH, osmotic pressure concentration, viscosity, temperature, etc.). The sensor may be located upstream, downstream or in one or more pump chambers. In one embodiment, a pressure sensor is located in the inlet flow path of the pump head to monitor the suction head, for example to detect the proper operating conditions during use. The sensor can also be used to detect errors in the setting of the inlet flow path or interruptions and obstructions of the inlet flow path, such as throttling of a pipe that is too long, too small in diameter, blocked or squeezed. The sensor information can be used in the installation program and / or installation test for the pump and / or flow kit. The sensor can be connected to a display at the pump and / or pump head, or can be connected to the system and its control system. The information from the fluid sensor can also be used in the previously mentioned scope of asset performance management. In various exemplary embodiments of the present invention, at least one pressure sensor can be located in the outlet flow path of the pump head to monitor the pump pressure. The pressure sensor can also be used to detect errors in the setting of the outlet flow path or interruptions and obstructions of the outlet flow path, such as, for example, throttling by a pipe that is too long, too small in diameter, blocked or squeezed. The sensor information can be used in an installation program and / or installation test for a pump and / or flow kit. The sensor can be connected to a display at the pump and / or pump head, or can be connected to the system and its control system. In various exemplary embodiments, at least one pressure sensor is provided in the inlet flow path, and at least one pressure sensor is applied in the outlet flow path of the pump head. Having pressure sensors at both the inlet path and the outlet path of the pump head can be used to monitor the pump efficiency of the pump head.

[0076] In one embodiment, the pump head and / or pump driver are provided with a marking device for information storage, which can be deployed to identify components or read specific component details, such as, for example, production or sterilization date, calibration data, QC information, etc. Information can be stored by RFID tags, bar codes, 2D bar codes, etc., and the corresponding reader for reading information can be located at the pump driver or instrument and system. Portable readers can also be used to read information before, during, and after the pump component is used with the system. The information about the component can be used for batch record documents and for controlling (electronic) workflow instructions during processing (including the installation, removal, and disposal of the pump head). When applied to a reusable pump head, cleaning, service, and / or storage information can be (re) written and updated on an identifier or an associated separate label, display, or memory component. In one embodiment of the present invention, information is stored on an eINK display in a digital or barcode label format.

[0077] In another embodiment of the present invention, the pump head is made of a transparent or opaque material that allows visual inspection of the interior of the pump chamber. Suitable materials may be, for example, acrylic, polycarbonate or COC (cyclic olefins, such as TOPAS). Visual inspection allows the user to visually inspect the movement of the pump diaphragm, the action of the check valve, the presence, movement or displacement of liquid and / or air, and / or the speed of the pump action itself or obtain feedback about it. In one embodiment, the pump chamber is illuminated by a light source to increase visibility. In another embodiment, the light intensity and / or color of the lightning changes, and / or the characteristics or frequency of the lightning enhancement changes, depending on the pump operation, operating parameters, or other parameters of the pump or system. In one embodiment, when the diaphragm is in a certain position (such as, the discharge position), the intensity of the light enhancement in the pump chamber changes throughout the pump stroke as the diaphragm position changes due to the obstruction of the light path.

[0078] Polymers such as polypropylene, polyethylene, peek, Topas, etc. can be used for the rigid pump head housing member. The diaphragm 13 and / or the one-way valve can be made of an elastomer, typically a thermoplastic elastomer (TPE) such as Santoprene, Mediprene. The elastomer part can be selected so that the best performance is achieved with / after sterilization and gamma irradiation, respectively.

[0079] In another embodiment of the present invention, the wobble plate 35 action can be translated into axial movement of an individual axial piston for each diaphragm. Axial actuation of each diaphragm can result in improved performance and extended diaphragm life compared to the angled engagement in the case of the diaphragm engagement plate 27.

[0080] In some embodiments of the present invention, the pump head 1; 101; 201 is a single-use pump head, and the pump drive 31 is reusable. The pump head may be suitably pre-sterilized, for example by gamma irradiation. The pump head may be provided with a sterile connector. The pump drive may also be connected to a single-use flow path providing a single-use flow path assembly according to the present invention. Single-use (also referred to as disposable) components are suitable in many bioprocessing systems due to the requirements for sterilization or aseptic conditions in many systems. The advantage of using a single-use technology (SUT) fluid handling device is mainly that when the SUT device is used only for a single drug product, cross-contamination between production batches and activities is reduced or completely eliminated. The SUT device is disposed of after use (which may be after a single run, batch, or an activity including multiple runs and batches). When a pre-sterilized or bioburden-controlled SUT device is provided, initial cleaning and sterilization (e.g., by contacting the flow path with a sodium hydroxide solution) or sterilization can be avoided. When the SUT is used only for a single run or batch, even post-use cleaning can be omitted. In the presence of these features, the SUT device provides improved efficiency, safety, and convenience.

[0081] The pump head 1; 101; 201 may be a closed compartment without seals, which has been produced from a number of plastic layers that have been connected by a welding method, such as, for example, diffusion bonding. Such a production method may provide a pump head 1; 101; 201 that can handle pressures up to at least 20 bar. Thereby, there is no need to provide the pump head with a gasket. Furthermore, the diffusion bonding production method will avoid the use of screws and seals. The pump body may be manufactured as a single piece by means of layer-by-layer formations, such as, for example, so-called 3D printing or additive manufacturing. Thus, a plastic structure may be made, or a metallized formation may be made and post-processed to make a reinforced metal pump body.

[0082] According to the present invention, furthermore, a single-use flow path assembly for a bioprocess system (such as, for example, a separation system, a purification system, a chromatography system, a filtration system, a bioreactor or a module in a personalized medical system) is provided. The single-use flow path assembly comprises a pump head 1; 101; 201 as described above connected to a single-use flow path. The single-use flow path assembly may be pre-sterilized.

[0083] According to the present invention, there is also provided a bioprocess system comprising a diaphragm pump as described above, such as, for example, a separation system, a purification system, a chromatography system, a bioreactor or a module in a personalized medical system.

[0084] In some embodiments of the invention, the inlet and outlet may be connected via an outer portion 161; 161' and a separate channel 162; 162'. Figure 7a and Figure 7bThe outer portion 161; 161' includes only Figure 7b The pressure regulating valve 163 is seen in FIG. Figure 7b In the figure, a pressure regulating valve 163 in the form of a membrane is shown. More than one membrane may also be provided to avoid liquid to remain inside the outer part 161 '. The outer part 161; 161 ' and the separate channels 162; 162' enable a pump that can be set to a specific pressure that it can give as its maximum value. If a higher pressure is provided, the liquid will circulate inside the pump instead of being pushed forward. In various exemplary embodiments of the present invention, the inlet and / or outlet of the diaphragm pump may be a sterile fluid connection. The sterile fluid connection may be advantageous in a bioprocess system in which the pump is not preassembled into a bioprocess fluid path upstream and / or downstream of the diaphragm pump.

[0085] A method for integrity testing using air may also be provided by the present invention. The pump according to the present invention has improved performance and capability with respect to check valve tightness when pumping air. The pump not only allows robust self-priming at large suction heads, but the pump also allows reliable and accurate pumping and compression of air. We therefore propose a new method of using the pump in single-use applications where flow path and component testing without the introduction of liquids should be preferred. Prior art systems rely on the application of liquids for conducting performance tests and installation verification tests.

[0086] A method for testing and verifying the integrity of a diaphragm pump according to the invention and / or a flow path assembly including a diaphragm pump according to the invention is proposed, the method relying on pumping air and compressing the air downstream of the pump. In one embodiment of the method for pumping air and compressing air, a pressure decay method is applied, wherein a pump is used to compress air against a closed fluid path downstream of the pump until a certain pressure is reached in a first step, and wherein the pressure loss over time is monitored in a second step using a pressure sensor positioned in the pressurized fluid path. As a result, for example, the air tightness of the fluid path can be quantified, and the result can be compared with a predefined acceptance standard. In another embodiment, a constant flow pressure method is applied, wherein a pump is used to maintain a target air pressure or a pressure within an error band by pumping air in an incremental or continuous manner, and wherein the pump speed or number of pump strokes required to maintain the pressure is evaluated to derive a leakage quantification for the fluid path. Furthermore, the determined pumping action can be compared with a predefined acceptance standard. In one embodiment, the information obtained from the air pumping and compression is used to identify, verify or calibrate a pump or component of a flow path assembly. In another embodiment, the air pumping and compression is used to determine and / or verify the correct configuration of flow path components, such as correct flow path size and length or correct operation of flow path or system components (e.g., valves, sensors, and pumps).

[0087] As discussed above, in some embodiments of the present invention, the pump head is assembled by diffusion bonding. Thus, some elastomeric functional components (such as, inlet valve 9 and outlet valve 11 and diaphragm 13) are integrated into the combined design, and some seals that are necessary for other production methods can be avoided. This is suitable, because a closed design with very little material is realized, and such a device is realized, that is, the device has improved tightness, pressure resistance and is easier to clean than the device assembled by other methods. Elastomer components need to be selected so that they will not be destroyed or decayed due to the heat provided during the bonding process. In various exemplary embodiments of the present invention, the diaphragm 13 may include an elastomer layer and a reinforcing layer. The reinforcing layer may be embedded in the elastomer layer. In various exemplary embodiments of the present invention, the diaphragm 13 includes a layered structure, at least one elastomer layer and at least one reinforcing layer. In various exemplary embodiments, the reinforcing layer may be a mesh structure made of fabric or elastomeric material, thereby having less elasticity than the elastomer layer. In the layered structure of the diaphragm, the reinforcing layer may be provided on the opposite side to the liquid or biomaterial contacting surface, ie attached to the non-liquid or non-biomaterial contacting surface of the pump head.

[0088] Figures 17a-17dA first exemplary embodiment of a quick-connect fastener for removably fastening the pump head 1 to the pump driver 31 is depicted in various views. Figures 17a-17d In the figure, only the top portion 31' of the pump driver 31 is shown. The top portion 31' includes a first support structure 170 and a second support structure 171 that are spaced apart from each other and configured to receive the pump head 1. The first support structure 170 and the second support structure 171 are configured to restrict lateral movement of the pump head along at least one lateral direction. The second support structure 171 includes a resilient member 175 that can be operated between a locked position in which the pump head 1 is locked to the pump driver 31 and an unlocked position in which the pump head 1 can be released and removed from the pump driver 31. Fig.17a , the pump head 1 is attached and locked to the pump drive 31. The pump head 1 may include a locking device in the form of at least one recess 180, 182, which is configured to receive a corresponding locking device in the form of a protrusion 174', 173 respectively provided in the support structure 170, 171. The first recess 182 and the second recess 180 in the pump head 1 may be fixed. The first protrusion 173 provided in the first element 170 may also be fixed. The second protrusion 174' is provided in the resilient member 175. The resilient member includes a guide element 174 configured to move in an opening 176 in the second element 171. A flange 172 provided on the top portion of the resilient member 175 can be used to operate the resilient member in an open position. At least one spring 190 will force the resilient member 175 to be located in a closed position. A first stop flange 177 provided at a first end of the guide element 174 can be used to restrict the movement of the resilient member 175 in the closed position when the pump head 1 is not arranged in the pump drive 31. The first stop flange 177 is configured to move in a recess 178 of the second element 171. The recess is larger than the opening 176, and the first stop flange 177 is larger than the opening 176. A second stop flange 179 provided at a second end of the guide element 174 can be used to restrict the movement of the resilient member 175 in the open position. The second stop flange 179 contacts the second element 171 in the fully open position, and the second stop flange 179 can contact the pump head 1 in the fully closed position. The first stop flange 177 can be removable from the guide element 174. The stop flange 177 can be attached to the guide element using at least one screw 177'.

[0089] Fig.17b A cross-sectional perspective view depicting the pump head 1 locked in the pump drive 31 . Fig.17cDepicts a cross-sectional perspective view of the pump head 1 released from the pump drive 31. Fig.17c , the first protrusion 173 and the second protrusion 174' are released from the corresponding first recess 182 and the second recess 180. At least one spring 190 may be provided between the second elements 171 and assist the resilient member 175. The at least one spring may be laterally fixed to the resilient member 175 by means of a spring protrusion 194 and laterally fixed to the second element by a spring recess 192. The spring recess 192 is configured to receive the spring and the spring protrusion 194.

[0090] Figures 18a-18f A second exemplary embodiment of a quick-connect fastener for removably fastening the pump head 1 to the pump driver 31 is depicted in various views. In this embodiment, the pump head 1 will be fixed in a supporting structure in the form of a frame 200 arranged on the top portion 31' of the pump driver 31. A resilient member 280 is attached to the frame 200. The resilient member 280 has a stop member 204 on its top portion. The stop member 204 is configured to move laterally from the center of the frame in an outward direction when the rotating cam member 202 is in the open position. The rotating cam member 202 is shown in Figure 18 as being rotatable between the open position and the locked position. In the open position, there is no contact between the rotating cam member 202 and the stop member 204, and the flat surface portion 208 of the rotating cam member 202 faces the rear end 240 of the stop member 204. In the locked position, there is contact between the rotating cam member 202 and the stop member 204, with the cam portion 206 facing toward the rear end 240 of the stop member 204. In the locked position, the cam portion 206 of the rotating cam member 202 prevents the stop member 204 from moving away from the pump head, i.e., the downwardly facing inclined surface 224 of the stop member 204 is attached to the corresponding upwardly facing inclined surface 210 of the pump head 1. Figures 18a-18fIn the embodiment of the present invention, the upward-facing skewed surface 210 of the pump head 1 is provided as a recessed portion on the perimeter of the top surface of the pump head. In various exemplary embodiments, the entire perimeter of the top surface may be skewed. When the rotating cam member 202 is in its open position, the skewed surface is used to easily remove the pump head 1 from the pump driver 37. Similarly, in order to easily assemble the pump head 1 to the pump driver 37, the skewed perimeter of the bottom surface 220 of the pump head 1 is configured to slide against the upward-facing skewed surface 222 of the stop member 204. The pump head 1 can be connected to the pump driver 37 and disconnected from the pump head 1 from the pump driver 37 only when the locking member is in its open position, thereby allowing the stop member 204 to move outwardly from its position via the resilient member 280. The rotating cam member 202 may have a handle 270 for manually rotating the rotating cam member 202 between the locked position and the open position. The rotating cam member 202 may have a rotating shaft 272 configured to be rotatably movable in a corresponding well provided in the frame 200. In various exemplary embodiments, the movement of the rotating cam member 202 may be accomplished by means of at least one electric motor. In various exemplary embodiments, the stop member may be locked and unlocked by a device other than the depicted rotating cam member 202, and the stop member may be a sliding bar that is arranged to contact the rear end 240 of the stop member 204 in the locked position and to be removed away from the rear end 240 in the open position. The locking device includes the rotating cam member 202, the stop member 204, and an upwardly facing skewed surface 210.

[0091] Figures 19a-19h A third exemplary embodiment of a quick-connect fastener for removably fastening the pump head 1 to the pump driver 31 is depicted in various views. Similar to the embodiment in Figure 18, the top portion 31' of the pump driver 31 includes a support structure in the form of a frame 300 configured to receive the pump head 1. The rotatable ring 302 is configured to lock and unlock the pump head 1 relative to the pump driver 31. The rotatable ring 302 has a first inner segment 320a, 320b, 320c, 320d with a first inner diameter and a second inner segment 360a, 360b, 360c, 360d with a second inner diameter. The first inner diameter is smaller than the second inner diameter. The second inner segments 360a, 360b, 360c, 360d may be evenly distributed around the ring 300. Fig.19a , Fig.19c , Fig.19e as well as Figure 19gIn the embodiment of the present invention, the second inner sections 360a, 360b, 360c, 360d are aligned with corresponding recesses 340a, 340b, 340c, 340d in the corners of the frame 300, thereby allowing the pump head 1 to be attached to the pump driver 31. The rotation of the ring 302 from the open position to the locked position will move the first inner sections 320a, 320b, 320c, 320d with a smaller inner diameter to slide into corresponding locking recesses 310a, 310b, 310c, 310d provided in the corners of the pump head 1. The rotation of the ring 302 can be performed manually by applying a tangential force relative to the ring on the handle 304. In various alternative embodiments, the rotation of the ring 302 can be performed by at least one electric motor. The locking means comprises the first inner sections 320a, 320b, 320c, 320d and the locking recesses 310a, 310b, 310c, 310d.

[0092] Figure 20a-20h A fourth exemplary embodiment of a quick-connect fastener for removably fastening the pump head 1 to the pump driver 31 is depicted in various views. The top portion 31' of the pump driver 31 includes a first support structure 400 and a second support structure 400' that are laterally spaced apart and configured to receive the pump head 1. The first element 400 and the second element 400' are configured to restrict movement of the pump head 1 in a first opposite direction. The top portion 31' further includes a third support structure 402 and a fourth support structure 402' that are laterally spaced apart and configured to receive the pump head 1. The third support structure 402 and the fourth support structure 402' are configured to restrict movement of the pump head 1 in a second opposite direction, which is perpendicular to the first direction. At least one of the first support structure 400 and the second support structure 400' includes at least one vertical recess 404a, 404b, 404c configured to receive a corresponding vertical protrusion 500a, 500b, 500c arranged on the pump head 1. In Fig.20c, the pump head 1 is attached to the pump driver 31, but is in an unlocked position. In the unlocked position, the front surface 510 of the pump head 1 may contact the third support structure 402. By sliding the pump head 1 toward the fourth support structure 402', the pump head will be in a locked position. In the locked position, the rear end 530 of the pump head 1 may contact the fourth support structure 402'. When the rear end 530 of the pump head 1 contacts the fourth support structure, the at least one recessed portion 404a, 404b, 404c in the first support structure 400 and the second support structure 400' is not aligned with the protrusions 500a, 500b, 500c on the pump head 1, respectively, making it impossible to remove the pump head 1 from the pump driver 31. Removing the pump head 1 from the pump driver 31 is performed by sliding the pump head 1 toward the third support structure 402, so that the front surface 510 of the pump head 1 contacts the third support structure 402. When the front surface 510 of the pump head 1 contacts the third support structure 402, the protrusions 500a, 500b, 500c are aligned with the corresponding recesses 404a, 404b, 404c in the first support structure 400 and the corresponding recesses 404a', 404b', 404c' in the second support structure 400'. The first sliding recess 406 in the first support structure 400 is configured to receive the protrusions 500a, 500b, 500c and allow the pump head 1 to move back and forth from the third support structure and the fourth support structure 402'. Similarly, the second sliding recess 406' in the second support structure 400' is configured to receive the protrusions 500a', 500b', 500c' (not shown) and allow the pump head 1 to move back and forth from the third support structure 402 and the fourth support structure 402'. The locking means includes the protrusions 500a, 500b, 500c, 500a', 500b', 500c', the recesses 404, 40b, 404c, 404a', 404b', 404c' and the sliding recesses 406, 406'.

[0093] Figures 21a-21g A fifth exemplary embodiment of a quick-connect fastener for removably fastening the pump head 1 to the pump driver 31 is depicted in various views. Similar to the second embodiment as depicted in FIG. 18 , the pump head 1 is to be fixed in a support structure in the form of a frame 600 arranged on the top portion 31 ′ of the pump driver 31 .

[0094] The resilient member 280 is attached to the frame 620. The resilient member 280 has a stop member 204 on its top portion. The stop member 204 is configured to move laterally from the center of the frame 620 in an outward direction when the depressible member 600 is in the open position. The depressible member 600 is shown in Figure 21 as being depressible between the open position and the locked position. In the open position, when the depressible member is depressed, there is no contact between the depressible member 600 and the stop member 204. In the open position, the blocking surface 240 is laterally spaced from the corresponding blocking surface 290 of the stop member 204. In the locked position, there is contact between the blocking surface 240 of the depressible member 600 and the blocking surface 290 of the stop member 204. In the locked position, the pump head 1 is prevented from moving away from the pump drive 31 , ie the downwardly facing inclined surface 224 of the stop member 204 is attached to a corresponding upwardly facing inclined surface 210 of the pump head 1 .

[0095] exist Figures 21d-21g In the embodiment of the present invention, the upward-facing skewed surface 210 of the pump head 1 is provided as a recessed portion on the perimeter of the top surface of the pump head. In various exemplary embodiments, the entire perimeter of the top surface may be skewed. When the depressible component 600 is in its open position, the skewed surface is used to easily remove the pump head 1 from the pump driver 31. Similarly, in order to easily assemble the pump head 1 to the pump driver 31, the skewed perimeter of the bottom surface (not shown) of the pump head 1 is configured to slide against the upward-facing skewed surface 222 of the stop member 204. Only when the depressible component 600 is in its open position, thereby allowing the stop member 204 to move outward from its position via the resilient component 280, can the pump head 1 be connected to the pump driver 31 and the pump head 1 be disconnected from the pump driver 31. The depressible member 202 may have a shaft 604 configured to move in a corresponding well 606 provided in the frame 620. A spring 602 is disposed between the frame 620 and the depressible member 600. In various exemplary embodiments, the movement of the depressible member 600 may be accomplished by means of at least one electric motor. The locking device includes the depressible member 600, the stop member 204, and the upwardly facing inclined surface 210.

[0096] The improved arrangement shown in the accompanying drawings solves various problems associated with the prior art and, in particular, the improved arrangement is more compact, has less potential for entrapped air, which improves cleanability, and provides flow with low pulsation across a relatively wide range of flows and pressures.

[0097] It will be apparent to the skilled person that additions, omissions and modifications to the embodiments described above are possible without departing from the scope of the claimed invention.

Claims

1. A diaphragm pump for a bioprocess system, comprising: Pump head (1; 101； 201； 301), which includes: Public entrance (3); Public exits (5); a plurality of pump chambers (7), each comprising at least one pair of cooperating one-way valves, the at least one pair of one-way valves comprising an inlet valve (9) and an outlet valve (11), wherein the respective inlet valves (9) are in fluid communication with the common inlet (3), and the respective outlet valves (11) are in fluid communication with the common outlet (5), and wherein: when the diaphragm pump is oriented for inhibiting trapped gas, for the same pump chamber (7): a) the center of the outlet valve (11) for each pump chamber is positionable above the center of the inlet valve (9); or b) the center of flow of the respective outlet valve (11) is positioned above the respective center of flow of the inlet valve (9); a plurality of movable diaphragms (13), each of which is respectively provided in a corresponding pump chamber (7) so as to change the volume of the pump chamber (7); at least one leakage collector (21, 121); and A pump drive (31) is configured to transfer movement to the diaphragm (13) of the pump head (1; 101; 201) as a result of the change in the volume of the pump chamber (7) so as to achieve fluid displacement from the common inlet (3) to the common outlet (5) of the pump head (1; 101; 201; 301).

2. The diaphragm pump according to claim 1, wherein The inlet valve (9) and the outlet valve (11) comprise flexible valve discs (9a, 11a), each disc comprising a substantially central retaining rod (9b, 11b) for holding the valve disc in place.

3. The diaphragm pump according to claim 2, wherein: The inlet valve (9) and the outlet valve (11) comprise outer sealing areas (9c, 11c) of the flexible valve discs (9a, 11a), the outer sealing areas (9c, 11c) being configured to seal at least partially against corresponding valve seats (90c) in the pump head (1; 101; 201; 301), and wherein the outer sealing areas (9c, 11c) are made of a first material that is softer than a second material in the remainder of the inlet valve (9) and the outlet valve (11).

4. The diaphragm pump according to claim 3, wherein: The inlet valve (9) and outlet valve (11) further comprise the first softer material in the valve stem sealing area (9d, 11d), the first softer material being configured to at least partially seal against a corresponding valve sealing surface (90d) in the pump head (1; 101; 201; 301).

5. The diaphragm pump according to claim 3 or 4, wherein: The softer material in the outer sealing area (9c, 11c) of the flexible valve disc (9a, 11a) and / or the valve stem sealing area (9d, 11d) of the flexible valve disc (9a, 11a) is applied as a layer (9", 11") of a predetermined thickness to at least a portion of the core (9', 11') comprising the second material.

6. The diaphragm pump according to any one of claims 2 to 5, wherein: At least a portion of the valve stem (9b, 11b) has a frustoconical shape.

7. The diaphragm pump according to any one of claims 1 to 6, wherein: The movable diaphragm (13) comprises a reinforcement layer and an elastomer layer.

8. The diaphragm pump according to claim 7, wherein The reinforcement layer is embedded in the elastomer layer.

9. The diaphragm pump according to claim 7 or 8, wherein: The reinforcement layer comprises a mesh structure made of textile or elastomeric material, thereby having less elasticity than the elastomeric layer.

10. The diaphragm pump according to claim 8 or 9, wherein: The elastomeric layer is oriented to contact a portion of the diaphragm pump that contains a liquid.

11. The diaphragm pump according to any one of claims 1 to 10, wherein: i) the pump head (1; 101; 201) further comprises a pivoting device (25), the pivoting device (25) being provided at a center (C) of a diaphragm engaging plate (27) of the pump head so as to provide a pivot point at the center (C) of the diaphragm engaging plate (27); ii) the at least one leakage collector (21; 121) comprises a flexible bellows surrounding the pump chamber (7) and the diaphragm (13) and configured to collect possible leakage from the pump chamber (7); iii) the pump drive (31) comprising a rotating drive shaft (33) and a wobble plate (35) connected to the drive shaft (33) via a bearing (37) at an inclined angle, wherein the wobble plate (35) is configured for connection to the pump head (1; 101; 201; 301) so as to transfer movement from the rotating drive shaft (33) to the diaphragm (13), optionally wherein the pump drive (31) is configured to apply active modulation of the pump speed to the rotation of the drive shaft (33) so as to compensate for pulsations of the pump; iv) the pump head (1; 101; 201) comprises three or five pump chambers (7) radially distributed around the center (C) of the pump head (1; 101; 201; 301); v) the diaphragm engagement plate (27) of the pump head (1; 101; 201; 301) and the wobble plate (35) of the pump drive (31) include cooperative connection features (41a, 41b) provided to avoid rotational friction between the diaphragm engagement plate and the wobble plate; vi) the pump head (1; 101; 201) is a single-use pump head, and the pump driver (31) is reusable; vii) the pump head (1; 101; 301) provides a closed compartment without seals and is produced from a plurality of plastic layers connected by diffusion bonding, the closed compartment comprising at least the inlet valve (9) and outlet valve (11) and the diaphragm (13) as an integrated elastomeric functional component; viii) providing a quick-connect fastener for removably fastening the pump head (1; 101; 301) to the pump driver (31), optionally wherein the quick-connect fastener is operable between a locked position in which the pump head (1; 101; 301) is locked to the pump driver (31) and an unlocked position in which the pump head (1; 101; 301) can be released from the pump driver (31) and removed; ix) the pump drive (1; 101; 301) comprises at least one support structure (170, 171, 200, 300, 400, 400', 402, 402', 620) for constraining movement of the pump head (1) in at least one direction when attached to the pump drive (31); and / or x) At least one locking means is movably attached to the pump drive (31).

12. A diaphragm pump according to any one of the preceding claims, wherein: i) at least one of the plurality of movable membranes (13) is manufactured with an auxiliary layer; ii) at least one of the plurality of movable diaphragms (13) and / or the one-way valves (9, 11) is made of an elastomer; iii) at least one of the plurality of movable diaphragms (13) and / or the one-way valves (9, 11) is made of thermoplastic elastomer (TPE), Santoprene and / or Mediprene; and / or iv) The at least one leakage collector (21, 121) comprises a leakage sensor applied to its lower end, the leakage sensor optionally comprising a conductivity sensor, a total reflection prism for optical detection or a force gauge.

13. A diaphragm pump according to any one of the preceding claims, wherein The leakage collector (21) is arranged between the diaphragm engaging plate (27) and the diaphragm retaining plate (28) of the pump head (1; 101; 201; 301).

14. A diaphragm pump according to any one of the preceding claims, wherein The leakage collector (21) comprises a bottom discharge port (123) which is optionally provided with a sterile connector.

15. The diaphragm pump according to claim 14, further comprising a second port (125) which optionally allows draining of the leakage collector (121).

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