Diaphragm pump

Abstract

To provide a diaphragm pump for a bioprocess system.SOLUTION: A diaphragm pump comprises a pump head 1. The pump head includes: a common inlet; a common outlet; a plurality of pump cavities each including at least one cooperating pair of one-way valves, in which the at least one pair of one-way valves include an inlet valve 9 and an outlet valve 11, the respective inlet valves are in fluid communication with the common inlet, the respective outlet valves are in fluid communication with the common outlet, and a centre of the outlet valve for each pump cavity can be positioned above a centre of the inlet valve for the same pump cavity when the diaphragm pump is oriented in an usage state to inhibit trapped gas; and a plurality of moveable diaphragms 13 respectively provided in the respective pump cavities for varying a volume of the pump cavities. The system further comprises a pump drive that is configured to transfer a motion to the diaphragms of the pump head.SELECTED DRAWING: Figure 2

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 bioprocessing system, a one-way valve configured for use in a diaphragm pump, a moveable diaphragm (13) configured for use in a diaphragm pump, a quick connect fastener configured for use in a diaphragm pump, and a bioprocessing system. [Background technology]

[0002] Bioprocessing fluid transport, for example achieved by instruments and systems for transporting and processing fluids during cell culture, separation, purification, packing, sampling and analysis, requires a wide range of flow rates along with volumetric accuracy and precise control of fluid pressure. Many applications and processing steps also require minimal fluctuations in flow rate and / or pressure. Positive displacement pumps typically achieve the flow range required for bioprocessing, but their output is accompanied by pressure pulsations. Rotary pumps typically achieve stable pressures, but their flow range is limited, and high pressures are difficult to achieve without multiple pump stages and may be detrimental to the drug substance. Multiple pumps that work together to equalize pressure pulses are known, but a single pump is desirable for low cost and minimal holdup in the process. A single pump should also be easier to manage, maintain and maintain cleanliness, especially for hygienic, aseptic or sterile processing. A single pump is also preferred for single-use processing equipment, where liquid contacting components are replaced after use, eliminating the need and risk of equipment cleaning.

[0003] Diaphragm pumps have several advantages when used in the field of biological processing, for example, they do not impose high shear forces on the pumped liquid, making them preferable for pumping liquids containing cells, proteins, viruses, etc. Such pumps also have a reasonable range of flow rates and pressures. Multiple cavity diaphragm pumps have been proposed, for example one with parallel cavities driven by a swashplate is commercially available under the brand Quattroflow™. In some pumps, one problem can be air entrapment.

[0004] In the patent application WO 2005 / 023363, a multi-cavity diaphragm pump is described, in which the problems of venting and draining are discussed and attempted to be solved. In this 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 high in the chamber to aid in venting, and others are located low to aid in draining. However, all these outlet openings are covered by one and the same check valve. Therefore, the opening and closing of the separate outlet openings for venting and draining cannot be controlled separately. It is not possible to ensure that the top of the valve is open, especially at low flow rates. At low flow rates, only a part of the valve opens, and if it is the bottom of the valve that opens, the air will not escape properly. Therefore, high flow rates may be required to ensure the pump is vented. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] US Patent Application Publication No. 2018 / 0142684 Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENT EMBODIMENT It is an object of the present invention to provide an improved diaphragm pump.

[0007] It is a further object of the present invention to provide a diaphragm pump which has a reduced tendency to trap air.

[0008] It is a further object of the present invention to provide a pump that exhibits reduced pulsation. [Means for solving the problem]

[0009] This object is achieved by a diaphragm pump, a pump head, a single-use flow path assembly for a bioprocessing system and a bioprocessing system according to the independent claims.

[0010] According to one aspect of the present invention, there is provided a diaphragm pump, comprising: A pump head, Common entrance, common exit, a plurality of pump cavities each including at least a pair of cooperating one-way valves, the at least a pair of one-way valves including an inlet valve and an outlet valve, each inlet valve in fluid communication with a common inlet and each outlet valve in fluid communication with a common outlet, a center of the outlet valve for each pump cavity positionable over a center of the inlet valve for the same pump cavity when the diaphragm pump is oriented in a use state to inhibit trapped gas; a plurality of movable diaphragms disposed in the pump cavity for varying the volume of the pump cavity; a pump head including: a pump drive configured to transmit motion to a diaphragm of the pump head to effect fluid displacement from a common inlet to a common outlet of the pump head as a result of said varying a volume of a pump cavity; A diaphragm pump is provided comprising:

[0011] According to another aspect of the present invention, there is provided a pump head adapted for use in connection with a pump drive of a diaphragm pump, comprising: A common entrance and A common exit and a plurality of pump cavities each including at least a pair of cooperating one-way valves, the at least a pair of one-way valves including an inlet valve and an outlet valve, each inlet valve in fluid communication with a common inlet and each outlet valve in fluid communication with a common outlet, a center of the outlet valve for each pump cavity positionable over a center of the inlet valve for the same pump cavity when the diaphragm pump is oriented in a use state to inhibit trapped gas; a plurality of movable diaphragms disposed in the pump cavity for varying the volume of the pump cavity; A pump head is provided comprising:

[0012] According to another aspect of the present invention, there is provided a single-use flow path assembly for a bioprocessing system, said single-use flow path assembly comprising the above-mentioned pump head coupled to a single-use flow path.

[0013] According to another aspect of the present invention, there is provided a bioprocessing system comprising the diaphragm pump described above.

[0014] This provides a diaphragm pump that is highly accurate, linear, and fully purgable even at low flow rates. By providing an outlet valve above the inlet valve of each pump cavity, air does not become trapped inside the pump. This greatly improves sanitation as all internal surfaces within the pump cavity are fully wetted even when low flow rates and back pressures are used.

[0015] Additionally, a diaphragm pump is provided that is suitable for single use applications. Additionally, a cost-effective and flexible diaphragm pump is provided.

[0016] In one embodiment of the invention, the inlet and outlet valves include flexible valve discs, each of which includes a generally central retaining stem for holding the valve disc in place.

[0017] In one embodiment of the invention, the pump head further comprises a pivoting device provided at the center of the diaphragm engagement plate of the pump head to obtain a pivot point at the center of the diaphragm engagement plate, thereby ensuring that the diaphragm engagement plate engaging the diaphragm of the pump head always pivots about its center, thereby effectively pushing and pulling the diaphragm, thereby achieving complete filling of the pump cavity even at high motor frequencies and when the fluid inlet pressure is low, e.g., when the fluid source is located low relative to the pump.

[0018] In one embodiment of the invention, the pump head may further include at least one leak collector, which is a flexible bellows surrounding the pump cavity and the diaphragm and configured to collect possible leakage from the pump cavity.

[0019] Further embodiments are set out in the detailed description and in the dependent claims.

[0020] However, the invention also applies to any combination of features disclosed herein, regardless of whether such combination is expressly described or claimed herein. Further, where two or more features are described herein in combination, such features may also be claimed separately without broadening the scope of the invention.

[0021] The invention can be implemented in numerous ways, and example embodiments thereof are described below with reference to the drawings. [Brief description of the drawings]

[0022] [Figure 1a] FIG. 1 is a perspective view of a pump head according to one embodiment of the present invention. [Figure 1b] FIG. 13 is a diagram of a pump head with five cavities instead of three, according to another embodiment of the invention. [Diagram 2] FIG. 2 is an exploded view of a pump head according to one embodiment of the present invention. [Figure 3a] FIG. 2 is an exploded view of the pump head shown in FIG. 1. [Figure 3b] FIG. 2 illustrates a leak collector according to one embodiment of the present invention. [Figure 4] FIG. 13 is an exploded view of a pump head according to another embodiment of the present invention. [Figure 5a] FIG. 2 is a top cross-sectional view of a pump head in one plane according to one embodiment of the present invention. [Figure 5b] FIG. 2 is a top cross-sectional view of a pump head in another plane according to one embodiment of the present invention. [Figure 6] FIG. 2 is a side cross-sectional view of a portion of a pump head according to one embodiment of the present invention, illustrating flow within the pump head. [Figure 7a] FIG. 2 is a side cross-sectional view of a portion of a pump head according to one embodiment of the present invention. [Figure 7b] FIG. 2 is a side cross-sectional view of a pump head according to one embodiment of the present invention. [Figure 8a] FIG. 2 is a cross-sectional view of a pump head according to one embodiment of the present invention. [Figure 8b] FIG. 2 is a cross-sectional view of a pump head according to one embodiment of the present invention. [Figure 9a] FIG. [Figure 9b] FIG. [Figure 10a] FIG. [Figure 10b] FIG. 13 is a diagram of pump drive compensation. [Figure 11] FIG. 1 is a perspective view of a pump head according to one embodiment of the present invention. [Figure 12] Figure 12a shows a side view of an exemplary embodiment of an inlet or outlet valve of a pump head, and Figure 12b shows a partial cross-sectional side view of the inlet or outlet valve of Figure 12a. [Figure 13] FIG. 2 is a top view showing the inlet or outlet valve area of ​​the pump cavity. [Figure 14] FIG. 13 is an enlarged cross-sectional view of the sealing area of ​​the inlet or outlet channel. [Figure 15] 11A-11C are cross-sectional views illustrating alternative exemplary embodiments of the inlet or outlet valves of the pump head. [Figure 16] 13A-13C show further alternative exemplary embodiments of the inlet or outlet valves of the pump head. [Figure 17a] 1A-1C illustrate a first exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 17b] 1A-1C illustrate a first exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 17c] 1A-1C illustrate a first exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 17d] 1A-1C illustrate a first exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 18a] 13A-13C illustrate a second exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 18b] 13A-13C illustrate a second exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 18c] 13A-13C illustrate a second exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 18d] 13A-13C illustrate a second exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 18e] 13A-13C illustrate a second exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Fig. 18f]13A-13C illustrate a second exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19a] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19b] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19c] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19d] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19e] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19f] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19g] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 19h] 13A-13C illustrate a third exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20a] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20b] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20c] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20d] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20e] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Fig. 20f] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20g] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 20h] 13A-13C illustrate a fourth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 21a] 13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 21b] 13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 21c] 13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 21d] 13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Figure 21e] 13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Fig. 21f] 13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. [Fig. 21g]13A-13D illustrate a fifth exemplary embodiment of a quick connect fastener for releasably securing a pump head to a pump drive. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The present invention, together with its objects and advantages, may be better understood by reference to the following description taken in conjunction with the accompanying drawings, in which:

[0024] Although the drawings show several different embodiments of the invention, corresponding components are named and numbered similarly. For example, Figures 2, 3a and 4 show different embodiments of pump heads 1, 101, 201 according to the invention, although corresponding separate parts are numbered the same, and some details shown in other figures may be valid for more than one of the different embodiments.

[0025] Figures 2, 3a and 4 show exploded views of pump heads 1, 101 and 201. The pump heads 1, 101 of figures 2 and 3a are designed to be assembled by a suitable diffusion bonding or similar welding method, i.e. the parts are made of a suitable plastic and are compressed and heated to bond together. The diffusion bonding manufacturing method avoids the use of screws and sealants. However, other welding methods can be used as well, or alternatively the parts can be riveted together. In figure 4 another embodiment of the pump head 201 is shown, which is designed to be assembled by screws. However, most of the parts are the same or correspond to those of the pump heads 1, 101 shown in figures 2 and 3a.

[0026] FIG. 1a is a perspective view of the pump head 101 shown in FIG. 3a when assembled. FIG. 1b is a pump head 301 with five cavities 7 instead of three. FIGS. 5a and 5b are top cross-sectional views in different planes of the pump head 101 shown in FIG. 1 and FIG. 3a, but the design of this view is similar to all the embodiments shown in FIG. 2, FIG. 3a and FIG. 4. FIG. 6 is a side cross-sectional view of a part of the pump head 201 shown in FIG. 4, but the design of which is also very similar to the pump head shown in FIG. 2 and FIG. 3a. FIGS. 7a and 7b are side cross-sectional views of a pump head 101′, 101″ similar to that shown in FIG. 3a, but with an additional external part 161, 161′ for connecting the inlet and the outlet. FIGS. 8a and 8b show details of the pivot points that may be provided in all the embodiments of the invention.

[0027] Figure 9 shows a pump drive device 31 according to one embodiment of the present invention. The present invention will now be described with reference to all the drawings.

[0028] The present invention relates to a diaphragm pump comprising 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 use in conjunction with 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 cavities 7. Each pump cavity 7 comprises at least one cooperating pair of one-way valves, the at least one pair of one-way valves consisting of an inlet valve 9 and an outlet valve 11. Each inlet valve 9 is in fluid communication with the common inlet 3, and each outlet valve 11 is in fluid communication with the common outlet 5. In accordance with the present invention, the center of the outlet valve 11 for each pump cavity 7 can be positioned above the center of the inlet valve 9 for the same pump cavity 7 when the diaphragm pump is oriented in a use state that inhibits trapped gas. When the outlet valve 11 is located above the inlet valve 9 for each cavity 7, air will be effectively conveyed out of the pump head rather than being trapped. By providing one inlet valve 9 and one outlet valve 11 per cavity and positioning them so that the center of the outlet valve 11 for each cavity can be located above the center of the inlet valve 9 located in the same cavity, air can be effectively removed and the problem of trapped air is avoided. The positioning of the outlet valve relative to the inlet valve in each cavity can vary somewhat depending on the valve design and operation. The positioning does not necessarily have to be in all cases with the center of the outlet valve being located above the center of the inlet valve. Rather, the positioning will be with the flow center of the outlet valve being located above the flow center of the inlet valve.

[0029] The pump head 1, 101, 201 further comprises a movable diaphragm 13 provided in said pump cavity 7 for varying the volume of said pump cavity. The diaphragm pump drive 31 is configured to transmit motion to the diaphragm 13 of the pump head 1, 101, 201 for achieving a fluid displacement from the common inlet 3 to the common outlet 5 of the pump head 1, 101, 201 as a result of said varying the volume of the pump cavity 7.

[0030] The inlet valve 9 and the outlet valve 11 may include flexible valve disks 9a, 11a, each of which includes a generally central retaining stem 9b, 11b for holding the valve disk 9a, 11a in place. The flexible valve disks 9a, 11a may be crescent-shaped in cross section or alternatively flat. Such valves may be called umbrella valves and are preferred because they are symmetrical and can be used in an optimal space-saving manner. They can also be easily optimized for different pressure and sealing requirements. Possible valve materials include, for example, TPE, silicone, EPDM, etc. Duck valves are an example of another type of valve that can be used. The materials of these valves, as well as the dimensions and design of the valves, must be selected so that the opening and closing pressures of the valves are as small as possible. Figure 12a shows an exemplary embodiment of the inlet valve 9 or the outlet valve 11 in a side view. The inlet or outlet valve 9 or 11 includes a center retaining stem 9b, 11b, a flexible valve disk 9a, 11a, an outer sealing area 9c, 11c, and a valve stem sealing area 9d, 11d. FIG. 13 shows the inlet or outlet valve area 90 of the pump cavity as a top view. The inlet or outlet valve area 90 of the pump cavity includes a center hole 66 for holding and guiding the inlet center retaining stem 9b or the outlet center retaining stem 11b. The center hole 66 is not configured to pass fluid. The inlet or outlet valve area 90 of the pump cavity further includes eight inlet or outlet channels 61a, 61b, a valve seat 90c, and a valve sealing surface 90d. Although eight inlet or outlet channels are used in FIG. 13, in various exemplary embodiments, the number of channels may be more or less, for example, 2, 4, 5, 6, 10, 12, or 15. The multiple inlet channels 61a or outlet channels 61b may have the same or different diameters.

[0031] 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 valve 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 outlet channel 61b. In FIG. 14, the valve 9, 11 is in its closed position. That is, the outer sealing area 9c, 11c of the inlet valve 9 or 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.

[0032] In the closed position, a predetermined force can be applied to the central retaining stem 9b, 11b to ensure a liquid-tight closed position. In the open position of the inlet valve 9, the flexible valve disc 9a is deformed by the suction force of the diaphragm 13 and the flow of liquid from the inlet channel 61a. In the open position of the outlet valve 11, the flexible valve disc 11a is deformed by the flow of liquid from the outlet channel 61b. In the open position, the outer sealing area 9c, 11c of the inlet or outlet valve is at least partially out of contact with the valve seat 90c. In the open position, the valve stem sealing area 9d, 11d remains in contact with the valve sealing surface 90d to ensure that liquid does not pass through the central hole 66. The opening of the inlet or outlet valve 9 or 11 is performed by deforming the outer sealing area 9c, 11c such that the seal with the valve seat 90c is broken.

[0033] In various exemplary embodiments, the inlet valve 9 or outlet valve 11 is made of one homogenous single flexible material. In various exemplary embodiments, at least the outer sealing area 9c, 11c of the inlet valve 9 or outlet valve 11 may be made of a first material, whereas the core of the valve may be made of a second material. The first material of the outer sealing area 9c, 11c may be more flexible than the second material of the core of the valve 9, 11.

[0034] FIG. 12b shows an exemplary embodiment of an inlet or outlet valve 9, 11 in a partial cross-sectional side view with a core 9', 11' made of a first material and an outer layer 9", 11" made of a second material, which 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 seal against at least a portion of a corresponding valve seat 90c in the pump head 1, 101, 201, 301. The suitable flexibility of the second material provides both improved sealing properties and improved lifetime compared to prior art solutions.

[0035] In various exemplary embodiments, the inlet valve 9 and outlet valve 11 may also include the first soft material at valve stem sealing regions 9d, 11d configured to seal against at least a portion of a corresponding valve sealing surface 90d of 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.

[0036] In various exemplary embodiments, the soft 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 can be utilized as the layer 9", 11" having a predetermined thickness on top of the core 9', 11' having the second material. FIG. 15 shows a cross-sectional view of an inlet valve 9 or 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 can form part of the flexible disc 9a, 11a and the central retaining stem 9b, 11b. At least a portion of the central retaining stem 9b, 11b can have a frusto-conical shape. The truncated cone shape of the centering stems 9b, 11b reduces valve wear and friction as they slide within the central bore 66 of the pump cavity, thereby improving the life of the valves 9, 11.

[0037] Figure 16 shows an alternative exemplary embodiment of an inlet valve 9 or outlet valve 11 made of said first and second materials. In Figure 16, the central retaining stem 9b, 11b is made of said first material and the flexible valve disc 9a, 11a is made of said second material. In Figure 16, the core 9', 11' made of said first material is only partially covered by the outer layer 9", 11". In Figure 16, the outer sealing area 9c, 11c of the flexible valve disc 9a, 11a is made of said second material, whereas the valve stem sealing area 9d, 11d is made of said first material.

[0038] In the embodiment shown in Figure 1a and Figures 2 to 8, three pump cavities 7 are all provided in fluid communication with a common inlet 3 via respective pump cavity inlets 126. The embodiment shown in Figure 1b includes five pump cavities 7, but is otherwise similar to the other embodiments and will not be described in further detail. Each pump cavity inlet 126 includes a one-way inlet valve 9 that allows fluid flow into the pump cavity 7 but not out. Each pump cavity 7 is further in fluid communication with a common outlet 5 via a pump cavity outlet 130. Each pump cavity outlet 130 includes a one-way outlet valve 11 that allows fluid to exit the pump cavity 7 but not enter it. In another embodiment, multiple one-way inlet valves and / or multiple one-way outlet valves are provided.

[0039] Each pump cavity 7 further comprises a flexible material diaphragm 13 movable in a reciprocating motion in the direction of arrow R (illustrated in Figures 6 and 7) by actuation means 35 (one example being a wobble plate is shown in Figure 9). The actuation means may for example be by mechanical means coupled to a mechanical interface. Examples of other types of actuation means include pneumatic pressure fluctuations, hydraulic pressure fluctuations or mechanical action obtained from a motor or electric solenoid, etc.

[0040] Each pump cavity inlet 126 includes a number of inlet channels 61a arranged in this embodiment around a circle. And pump cavity outlet 130 includes a number of outlet channels 61b arranged in this embodiment around a circle. This can be seen in Figures 5a and 5b. All the multiple inlet channels 61a of each cavity 7 are 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 pressed by fluid pressure onto the inlet channels 61a to close the flow path and prevent fluid from escaping via the inlet channels 61a. The outlet valve 11 is similar in structure to the inlet valve 9, allowing fluid to leave the cavity 7 but not back in. The flexible diaphragm 13 consists in this embodiment of a disk-shaped moulding made of an elastomeric material. FIG. 6 shows one of the cavities 7 having multiple inlet channels 61a (which are central holes for holding the inlet valve retaining stem 9b, not for the passage of fluid) and multiple fluid outlet channels 61b, also with central holes for the outlet valve retaining stem 11b.

[0041] The pump head 1, 101, 201, 301 may further comprise a pivoting device 25 provided at the centre C of the diaphragm engagement plate 27 of the pump head 1, 101, 201, 301 in order to provide the diaphragm engagement plate 27 with a central pivot point around which the diaphragm engagement plate 27 can be tilted. This can be best seen in Fig. 8a and Fig. 8b. This ensures that the diaphragm engagement plate 27 engaging the diaphragm 13 of the pump head 1, 101, 201 always pivots about its centre C, thereby effectively pushing and pulling the diaphragm 13, thereby ensuring complete filling of the pump cavity 7 even at high motor frequencies and when the inlet pressure of the fluid is low, e.g. when the fluid source is located low relative to the pump. The pivoting device 25 may be, for example, a rubber element that can be pressed into the opening 26 of the diaphragm engagement plate 27. A recess 28a is provided in the diaphragm retaining plate 28, whereby said recess 28a is designed to receive a first end 25a of the pivoting device 25 protruding from the diaphragm engagement plate 27, whereby said pivoting device 25 is spaced between said diaphragm engagement plate 27 and said diaphragm retaining plate 28. Alternatives to the pivoting device 25 couple the wobble plate 35 and the diaphragm engagement plate 27, for example, by mechanical fixation, such as a clamp, by a bayonet or magnetically. Automatic features may be provided to achieve said mechanical or magnetic fixation, such as, for example, an electric or electromagnetic lock and / or the use of a reverse pump drive rotation.

[0042] The pump head 1, 101, 201 may further include a leak collector 21, 121, which is a flexible bellows surrounding the pump cavity 7 and the diaphragm 13 and configured to collect possible leaks from the pump cavity 7. The leak collector 21, 121 is shown in Fig. 3a and Fig. 3b. Although more than one leak collector may surround each pump cavity and diaphragm, for reasons of cost and simplicity, preferably one single leak collector 21, 121 is used to collect possible leaks from all pump cavities 7. The leak collector 21 may be an elastic bellows made from a highly flexible elastomer. As can be seen in Fig. 3a, the leak collector 21 may be provided between the diaphragm engagement plate 27 and the diaphragm retention plate 28 of the pump head. Such a leak collector 21 may be provided in the embodiment of the invention shown in Fig. 4 that is assembled by screws instead of diffusion bonding. The leak collector 21, 121 must seal against both the diaphragm engagement plate 27 and the diaphragm retention plate 28. A leak sensor (e.g., a conductive sensor, an optical detection total reflection prism as in a dishwasher, or a load cell) can be attached to the bottom of the leak collector 21, 121 to detect leaks. Alternatively, a change in pump flow rate at a given pump speed can be read as a failure of one pump chamber. When using the leak collector 21, 121 according to the invention, the diaphragm 13 can be fully optimized for optimal hardness to accomplish the pumping task over a large range, rather than compromising by, for example, adding a secondary layer to the diaphragm as in some prior art products to prevent leaks. The leak collector 21, 121 can also be clean and pre-sterilized, so that any process fluid collected by the leak collector 21, 121 can be collected without contamination.Furthermore, by using the leak collector 21, 121 according to the invention, no fluid is exposed outside the closed process line of the system, and therefore there is no risk of exposing the operator to harmful substances such as viruses. If any possible leak is contained within the single-use flow path (pump), no chamber decontamination is required. For example, the diaphragm retaining plate 28 can be provided with a drain passage and a sensor therein.

[0043] In Fig. 3b, a leak collector 121 according to another embodiment of the invention is shown. Such a leak collector 121 can be used for all the different pump heads 1, 101, 201, 301 described according to the invention. In this embodiment, the leak collector 121 comprises a lower exhaust port 123, which can optionally be equipped with a sterile connector. The lower exhaust port 123 can be used to exhaust and collect valuable or dangerous process fluids in case of any fluid leak from the pump chamber into the leak collector. The leak collector 121 is cleaned and sterilized in the same way as the rest of the pump head, so that any possible fluid leaks can be collected. A second port 125 can also be provided in the leak collector 121, which can be a vent port for venting the leak collector 121. The second port can be suitably located at the top position of the leak collector 121 when the pump head is attached to the pump driver. The second port 125 can be located on an opposite side of the leak collector 121 compared to where the exhaust port 123 is located. The second port 125 can include a sterile air filter that is optionally coupled to a pre-attached sterile connector.

[0044] A pump drive 31 according to one embodiment of the invention is shown in Figures 9a and 9b. The pump drive 31 may comprise a rotating drive shaft 33 and a wobble plate 35 connected at an angle to the drive shaft 33 via a bearing 37. The wobble plate 35 is adapted to connect to the pump head 1, 101, 201 in order to transfer the motion 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 angled connection via a bearing, e.g. a roll bearing, the wobble plate 35 may perform a circumferential wobbling motion without co-rotating with the drive shaft 33. This circumferential wobbling motion is transferred to the motion of the diaphragm 13, which provides the pumping action. The angle of inclination of the wobble plate 35 relative to the drive shaft 33 may be varied, which changes the maximum and minimum flow rates of the pump. The tilt angle can also be adjusted in a dynamic manner so that the angle, and therefore the pump stroke, can be adjusted without removing or replacing parts, and even during operation of the pump within or between separate processing operations and process steps.

[0045] In some embodiments of the invention, the pump drive 31 can be configured to apply an active modulation of the pump speed with respect to the rotation of the drive shaft 33 to compensate for pump pulsation. If three pump cavities are distributed radially around the center C of the pump head 1, 101, 201, the drive shaft can be controlled to increase its speed by, for example, about 15% every 120 degrees as the drive shaft sweeps through a particular angular position of the drive shaft to compensate for the momentary drop in flow rate between two discharge operations. Figure 10a shows the flow rate as a function of the A2 angular position of the drive shaft, i.e., the uncompensated outlet flow rate (i.e., constant angular velocity A2 of the drive shaft) from a diaphragm pump with three cavities 7 and three diaphragms 13 according to the invention. In Figure 10a, the flow rates from each cavity are denoted as F1, F2, F3, respectively, and the sum of the flow rates is shown as F1+F2+F3. This flow rate can be compensated by adjusting the A2 angular velocity as a function of the A2 angular position. The velocity modulation is 1 / (F1+F2+F3) and is shown in Figure 10b, which illustrates the motor velocity modulation as a function of angular position. It may be beneficial to compensate only at low angular velocities where the effects of pulsation are greatest. In some embodiments of the invention, active modulation of the pump speed may also be done dynamically using a pressure sensor to control the average motor speed in addition to a fixed modulation. In this embodiment, a motor with position control, such as a stepper motor, may be suitably used to allow alignment of the angular position of the drive shaft relative to the pump head.

[0046] The pump head 1, 101, 201 according to the invention can suitably comprise three or five pump cavities 7 radially distributed around the center C of the pump head 1, 101, 201. This advantageously results in a sinusoidal summation in the discharge operation, which significantly reduces pulsation compared to, for example, a four-cavity design. The reduced pulsation is particularly advantageous for low flow rates and low rotational speeds. This reduced pulsation allows the pump to be used over a wide operating range. Pulsation-free operation allows better, more stable and robust process control at low flow rates. Furthermore, if the above-mentioned active modulation is used, the pulsation is further reduced.

[0047] The diaphragm engagement plate 27 of the pump head 1, 101, 201 and the wobble plate 35 of the pump drive 31 may have cooperating interlocking features 41a, 41b provided to prevent any rotation and friction between the wobble plate 35 and the diaphragm engagement plate 27. This avoids wear of the components due to friction.

[0048] For single-use pump heads, it is preferable that no extra tools are required to attach the pump head to the device. This allows for easy attachment of the pump head to the pump driver, which is particularly advantageous for single-use pump heads. The connection between the pump head and the pump driver may further include an engagement lever and / or an automated solution that may be driven by a motor, pneumatically or magnetically. A circular locking mechanism may also be provided between the pump head and the pump driver.

[0049] A safe, efficient, and user-friendly installation procedure is critical to the efficiency, quality, and robustness of bioprocessing operations, especially for single-use pump heads where frequent installation and removal of the pump head from the pump drive is required for assembly and removal of the flow paths and consumables.

[0050] The pump head installation procedure may involve positioning, aligning and / or mounting the pump head to the instrument and / or the pump drive may require controlled actions to move or rotate parts relative to one another and clamp or lock components. These actions may be accomplished manually by an operator or may be partially or fully automated. The procedure may involve multiple steps, some steps may be accomplished manually and others by automation. Manual and / or automated steps may be assisted, for example, by motors, (electro)magnets, or pneumatics. Corresponding features may also assist in detaching and removing the pump head from the drive.

[0051] In some embodiments, the steps involved in installing and / or removing the pump head may be monitored and facilitated by sensors and / or indicators that show status information to the user. For example, a sensor may detect whether the pump head is in the correct position during one or more of said steps. The sensor may also monitor and verify that the pump head is in the correct position before, during and / or after operation of the bioprocessing system. In one embodiment, a counter is provided that tracks the usage of the pump head, for example by counting the number of revolutions or pump strokes. The counter may be realized mechanically or electronically by features located on the pump head, but information may also be provided by the control system and the instrument, for example by rewriting the RFID tag of the pump head, thereby obtaining updated information about the pump head, its status, usage status and / or usage history.

[0052] In another embodiment of the invention, the pump head includes indicators that display status information of the pump, e.g., pump running status, correct operation, idle status, flow rate or pressure information, information about trapped air, etc. The information may be displayed qualitatively, e.g., by changes in color, intensity, flashing frequency of light, such as an LED or display. In another embodiment, the light intensity and / or color of illumination changes and / or the nature or frequency of illumination enhancement changes depending on the pump operation, pump or system operating parameters or other parameters.

[0053] Alternatively, the information may be displayed quantitatively, for example by displaying numerical values ​​on a display surface that displays the current flow rate or pressure in numbers. Such a display surface may be suitably located, for example, on the pump head plate facing the user. A pump head 101' with a display 102 is shown in Figure 11, in this example the display 102 is provided on a side of the pump head 101'.

[0054] In one embodiment, a display made of LCD or the like is provided. In another embodiment, an eINK (electronic ink) display is provided that allows information to be retained on the display even when the display is not powered, thereby allowing current and relevant 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. This allows single-use pump head consumables to also display current information during storage, shipping, before or after use so that the user can easily see the status of the consumable. An eINK display with color display capabilities may be provided to accommodate the aforementioned information both during and before / after processing in storage, assembly, disassembly, disposal, recycling, etc.

[0055] In one embodiment, the display and / or eINK display can show up-to-date information about the pump head, its status, pre- and post-use status and / or usage history, and installation on the equipment and system. The information display can also display graphical information such as icons, arrows, graphs, etc. The displayed information can guide the user during the installation and assembly process, and for this purpose the display can be powered by an internal battery or an energy harvesting device. The information can be wirelessly transmitted to the pump head display or other local display means, such as the status light indicators mentioned above.

[0056] In another embodiment, the pump and / or pump head supports asset performance management (APM) by transmitting and / or displaying information such as status, functionality, history, wear, service interactions, etc., to enable, for example, improved monitoring, analysis, and prediction, planning and improvement of workflow. Sensors may be provided to support a range of asset performance management.

[0057] In another embodiment of the invention, the pump head includes sensors for monitoring process fluid properties such as, for example, pressure, conductivity, pH, osmolality, viscosity, temperature, etc. The sensors can be provided upstream, downstream, or within one or more pump chambers. In one embodiment, a pressure sensor is provided in the inlet flow path of the pump head to monitor the suction head and detect, for example, proper operating conditions during use. This sensor can also be used to detect errors during setup or interruptions and blockages in the inlet flow path, such as, for example, pinching due to tubing that is too long, too small in diameter, blocked, or pinched. Sensor information can be used for installation procedures and / or installation testing of the pump and / or flow kit. The sensor can be linked to a display of the pump and / or pump head, or linked to the system and its control system. Information from the fluid sensors can also be utilized for the scope of asset performance management discussed above. In various exemplary embodiments of the invention, at least one pressure sensor can be provided in the outlet flow path of the pump head to monitor the pump pressure. The pressure sensor can also be used to detect errors during setup or interruptions and blockages in the outlet flow path, such as choking due to tubing that is too long, too small in diameter, blocked, or pinched. The sensor information can be used in the installation procedure and / or installation testing of the pump and / or flow kit. The sensor can be connected to a display of the pump and / or pump head, or 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 attached to the outlet flow path of the pump head. Pressure sensors in both the inlet and outlet flow paths of the pump head can be used to monitor the pump efficiency of the pump head.

[0058] In one embodiment, the pump head and / or pump drive are provided with tagging means for information storage, which can be arranged for component identification or for reading out specific component details, such as, for example, manufacturing or sterilization dates, calibration data, QC information, etc. The information is stored by RFID tags, bar codes, two-dimensional bar codes, etc., and corresponding readers for reading out the information can be provided in the pump drive or in the equipment and system. Portable readers can also be used to read out the information before, during and after using the pump components with the system. Said information about the components can be used for batch documentation and for controlling (electronic) workflow instructions throughout the process, including installation, removal and disposal of the pump head. When applied to reusable pump heads, cleaning, service and / or storage information can be (re)written and updated on the identifier or associated separate tag, display or memory components. In one embodiment of the invention, the information is stored in the eINK display in a numeric or bar code tag format.

[0059] In another embodiment of the invention, the pump head is made of a transparent or opaque material that allows visual inspection of the inside of the pump chamber. Suitable materials may be, for example, acrylic, polycarbonate, COC (cyclic olefin, e.g. TOPAS). Visual inspection allows the user to visually confirm or get feedback on the movement of the pump diaphragm, the operation of the check valve, the presence, movement or displacement of liquid and / or air, and / or the speed of the pump operation itself. 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 illumination changes and / or the characteristics or frequency of the illumination enhancement changes depending on the pump operation, the pump or system operating parameters, or other parameters. In one embodiment, the light enhancement intensity in the pump chamber changes with the position of the diaphragm throughout the pump stroke due to light paths that are blocked when the diaphragm is in a particular position, such as the ejection position.

[0060] Polymers such as polypropylene, polyethylene, PEEK, Topas, etc. may be used for the rigid pump head housing components. The diaphragm 13 and / or one-way valves can be made of elastomers, typically thermoplastic elastomers (TPEs), such as Santoprene, Mediprene, etc. Elastomeric parts can be selected for optimal performance with / after sterilization and gamma irradiation, respectively.

[0061] In another embodiment of the invention, the motion of the wobble plate 35 can be translated into axial movement of one individual axial piston for each diaphragm. Driving each diaphragm axially can result in improved performance and extended diaphragm life compared to angular engagement using the diaphragm engagement plate 27.

[0062] In some embodiments of the invention, the pump head 1, 101, 201 is a single-use pump head and the pump drive 31 is reusable. The pump head can be suitably pre-sterilized, for example by gamma irradiation. The pump head can be equipped with a sterile connector. The pump drive can also be connected to a single-use flow path forming a single-use flow path assembly according to the invention. Single-use components, also called disposable, are suitable for many bioprocessing systems, since in many systems there is a requirement for aseptic or sterile conditions. The advantage of using single-use technology (SUT) fluid handling equipment is mainly that cross-contamination between manufacturing batches and campaigns is reduced or completely eliminated when the SUT equipment is used for only a single formulation. The SUT equipment is discarded after use, which can be after one run, batch, or a campaign including multiple runs and batches. When providing a pre-sterilized or bioburden-controlled SUT equipment, initial cleaning and disinfection (for example by contacting the flow path with sodium hydroxide solution) or sterilization can be avoided. Even cleaning after use can be omitted when the SUT is used for only one run or batch. These features make SUT equipment more efficient, safer and more convenient.

[0063] The pump head 1, 101, 201 can be a closed compartment without seals, manufactured from several plastic layers connected by a welding method, for example diffusion bonding. Such a manufacturing method allows to obtain a pump head 1, 101, 201 that can handle pressures up to at least 20 bar. This eliminates the need to provide the pump head with a backing plate. Furthermore, the diffusion bonding manufacturing method avoids the use of screws and seals. The pump body can be manufactured as one piece by forming it layer by layer, for example by so-called 3D printing or additive manufacturing. Thus, a plastic structure can be produced, or alternatively a metallized formation can be produced and post-processed to produce a connected metallic pump body.

[0064] According to the present invention, there is further provided a single-use flow path assembly for a bioprocessing system, such as a separation system, a purification system, a chromatography system, a filtration system, a bioreactor, or a module of a personalized medicine system. The single-use flow path assembly comprises the above-mentioned pump head 1, 101, 201 connected to a single-use flow path. The single-use flow path assembly can be pre-sterilized.

[0065] Also provided by the present invention is a bioprocessing system, such as a separation system, purification system, chromatography system, bioreactor, or module of a personalized medicine system, comprising the diaphragm pump described above.

[0066] In some embodiments of the invention, the inlets and outlets can also be connected via an external part 161, 161' and a separate channel 162, 162'. This can be seen in Figures 7a and 7b. The external part 161, 161' includes a pressure regulator 163, which is only visible in Figure 7b. In Figure 7b, the pressure regulator 163 is shown in the form of a membrane. Multiple membranes can also be provided to prevent liquid from accumulating inside the external part 161'. This external part 161, 161' and separate channels 162, 162' allow for a pump that can be set to a specific pressure that can be delivered as the maximum of the pump. If a higher pressure is provided, liquid will circulate in the pump instead of being pushed forward. In various exemplary embodiments of the invention, the inlet and / or outlet of the diaphragm pump can be a sterile fluid connection. A sterile fluid connection can be advantageous in bioprocessing systems where a pump is not pre-integrated into the bioprocessing fluid path upstream and / or downstream of the diaphragm pump.

[0067] A method of integrity testing using air can also be provided by the present invention. The pump according to the present invention has improved performance and capability in terms of check valve tightness when pumping air. The pump not only allows robust self-priming at large suction heads, but also allows reliable and accurate pumping and compression of air. Thus, the inventors propose a new method of using the pump in single-use applications where testing of flow paths and components without introducing liquids would be desirable. Prior art systems rely on utilizing liquids to perform performance and installation verification tests.

[0068] 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, which method relies on pumping air and compressing said air downstream of the pump. In one embodiment of the method for pumping and compressing air, a pressure decay method is applied, where in a first step, air is compressed using a pump until a certain pressure is reached for a closed fluid path downstream of the pump, and in a second step, the pressure loss over time is monitored using a pressure sensor arranged in the pressurized fluid path. As a result, the tightness of the fluid path can be quantified, which can be compared, for example, with predefined acceptance criteria. In another embodiment, a constant flow rate pressure method is applied, where a target air pressure or pressure is maintained within an error range by pumping air incrementally or continuously using a pump, and a leakage quantification of the fluid path is derived by evaluating the pump speed or number of pump strokes required to maintain said pressure. Again, the determined pumping behavior can be compared with predefined acceptance criteria. In one embodiment, information obtained from the air pumping and compression is used to qualify, verify or calibrate pumps or components of a flow path assembly. In another embodiment, the air pumping and compression is used to determine and / or verify the correct geometry of flow path components, such as the correct flow path size and length, or the correct operation of flow path or system components, such as valves, sensors and pumps.

[0069] As discussed above, the pump head is assembled by diffusion bonding in some embodiments of the present invention. This allows elastomeric functional components such as the inlet valve 9 and outlet valve 11, and the diaphragm 13 to be integrated into the adhesive design, thereby avoiding some seals that are required in other manufacturing methods. This is advantageous because it results in a closed design that requires less material, and also results in a device that is more airtight, more pressure resistant, and easier to clean compared to devices assembled in other ways. The elastomeric components must be selected so that they are not destroyed or altered by the heat applied in the adhesive process. In various exemplary embodiments of the present invention, the diaphragm 13 may include an elastomeric layer and a reinforcing layer. The reinforcing layer may be embedded in the elastomeric layer. In various exemplary embodiments of the present invention, the diaphragm 13 includes a layer structure of at least one elastomeric layer and at least one reinforcing layer. In various exemplary embodiments, the reinforcing layer may be a web structure made of a fabric or elastomeric material that has a lower elasticity compared to the elastomeric layer. In a layered construction of the diaphragm, said reinforcing layer may be provided on the side opposite the liquid or biological material contacting surface, i.e. on the non-liquid or non-biological material contacting surface of the pump head.

[0070] 17a-d show in various views a first exemplary embodiment of a quick connect fastener for releasably securing the pump head 1 to the pump drive 31. In Figs. 17a-d only an upper portion 31' of the pump drive 31 is shown. The upper portion 31' comprises a first support structure 170 and a second support structure 171 spaced apart from each other and configured to receive the pump head 1. The first and second support structures 170, 171 are configured to limit lateral movement of the pump head in at least one lateral direction. The second support structure 171 comprises a resilient member 175 movable between a locked position, in which the pump head 1 is locked to the pump drive 31, and an unlocked position, in which the pump head 1 is releasable and removable from the pump drive 31. In Fig. 17a the pump head 1 is attached and locked to the pump drive 31. The pump head 1 may comprise at least one locking means in the form of a recess 180, 182 arranged to receive a corresponding locking means in the form of a protrusion 174', 173 arranged on the support structures 170, 171, respectively. The first recess 182 and the second recess 180 of the pump head 1 may be fixed. The first protrusion 173 arranged on the first element 170 may also be fixed. The second protrusion 174' is arranged in the elastic member 175. The elastic member comprises a guide element 174 arranged to move in an opening 176 of the second element 171. A flange 172 arranged on the top of the elastic member 175 may be used to manipulate the elastic member in an open position. At least one spring 190 biases the elastic member 175 in a closed position. A first stop flange 177 at a first end of the guide element 174 can be used to limit the movement of the elastic member 175 in the closed position when no pump head 1 is arranged on the pump drive 31. The first stop flange 177 is arranged to move in a recess 178 in the second element 171, which recess is larger than the opening 176 and the first stop flange 177 is larger than the opening 176.A second stop flange 179 on a second end of the guide element 174 can be used to limit the movement of the elastic member 175 in the open position. The second stop flange 179 can contact 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 by at least one screw 177'.

[0071] Fig. 17b shows a perspective cross-sectional view of the pump head 1 locked to the pump drive 31. Fig. 17c shows a perspective cross-sectional view of the pump head 1 released from the pump drive 31. In Fig. 17c, the first protrusion 173 and the second protrusion 174' are released from the corresponding first recess 182 and second recess 180. At least one spring 190 may be provided between the second element 171 and the auxiliary elastic member 175. The at least one spring may be laterally fixed on the elastic member 175 by a spring protrusion 194 and laterally fixed on the second element by a spring recess 192. The spring recess 192 is configured to receive the spring and the spring protrusion 194.

[0072] 18a-18f show in various views a second exemplary embodiment of a quick connect fastener for releasably securing the pump head 1 to the pump drive 31. In this embodiment, the pump head 1 is secured to a support structure in the form of a frame 200 located on the upper part 31' of the pump drive 31. A resilient member 280 is attached to the frame 200. The resilient member 280 has a stop member 204 at its upper end portion. The stop member 204 is configured to move laterally outwardly from the center of the frame when the rotating cam member 202 is in the open position. The rotating cam member 202 is shown in FIG. 18 as being rotatable between an open position and a locked position. In the open position, the rotating cam member 202 and the stop member 204 are not in contact and a flat surface portion 208 of the rotating cam member 202 faces towards a rear end 240 of the stop member 204. In the locked position, the rotating cam member 202 and the stop member 204 are in contact and the cam portion 206 faces towards 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. That is, the downwardly inclined surface 224 of the stop member 204 is attached to a corresponding upwardly inclined surface 210 of the pump head 1. In Figs. 18a-18f, the upwardly inclined surface 210 of the pump head 1 is provided as a recess on the periphery of the top surface of the pump head. In various exemplary embodiments, the entire periphery of the top surface may be inclined. This inclined surface is used to facilitate removal of the pump head 1 from the pump driver 31 when the rotating cam member 202 is in the open position. Similarly, to facilitate assembly of the pump head 1 into the pump drive 31, a sloped periphery of the bottom surface 220 of the pump head 1 is configured to slide against the upwardly sloping surface 222 of the stop member 204. The pump head 1 can be coupled to and decoupled from the pump drive 31 only when the locking member is in its open position and the stop member 204 can be moved from its position by the elastic member 280.The rotating cam member 202 may have a handle 270 for manually rotating the rotating cam member 202 between the locked and open positions. The rotating cam member 202 may have a rotating shaft 272 configured to rotate in a corresponding well in the frame 200. In various exemplary embodiments, the movement of the rotating cam member 202 may be accomplished by at least one electric motor. In various exemplary embodiments, the stop member may be locked and unlocked by other means than the illustrated rotating cam member 202, which may be a sliding bar that is disposed in contact with the rear end 240 of the stop member 204 in the locked position and removed from the rear end 240 in the open position. The locking means includes the rotating cam member 202, the stop member 204, and the upwardly inclined surface 210.

[0073] 19a-19h show in various views a third exemplary embodiment of a quick connect fastener for releasably fixing the pump head 1 to the pump drive 31. Similar to the embodiment of FIG. 18, the upper part 31' of the pump drive 31 comprises a support structure in the form of a frame 300 configured to receive the pump head 1. A rotatable ring 302 is configured to lock and unlock the pump head 1 to the pump drive 31. The rotatable ring 302 has a first inner portion 320a, 320b, 320c, 320d having a first inner diameter and a second inner portion 360a, 360b, 360c, 360d having a second inner diameter. The first inner diameter is smaller than the second inner diameter. The second inner portions 360a, 360b, 360c, 360d may be evenly distributed around the ring 302. In Figures 19a, 19c, 19e and 19g, the second inner parts 360a, 360b, 360c, 360d are aligned with corresponding recesses 340a, 340b, 340c, 340d in the corners of the frame 300 so that the pump head 1 can be attached to the pump driver 31. When the ring 302 is rotated from the open position to the locked position, the first inner parts 320a, 320b, 320c, 320d with smaller inner diameters move to slide into corresponding locking recesses 310a, 310b, 310c, 310d in the corners of the pump head 1. The ring 302 can be rotated manually by applying a tangential force to the ring on the handle 304. In various alternative embodiments, the ring 302 can be rotated by at least one electric motor. The locking means comprises said first inner portions 320a, 320b, 320c, 320d and said locking recesses 310a, 310b, 310c, 310d.

[0074] 20a-20h show in various views a fourth exemplary embodiment of a quick connect fastener for releasably securing the pump head 1 to the pump drive 31. The upper portion 31' of the pump drive 31 comprises a first support structure 400 and a second support structure 400' arranged in a laterally spaced relationship and configured to receive the pump head 1. The first and second elements 400' are configured to restrict the pump head 1 from moving in a first opposing direction. The upper portion 31' further comprises a third support structure 402 and a fourth support structure 402' arranged in a laterally spaced relationship and configured to receive the pump head 1. The third and fourth support structures 402 and 402' are configured to restrict the pump head 1 from moving in a second opposing direction, the second direction being perpendicular to the first direction. At least one of the first support structure 400 and the second support structure 400' comprises at least one vertical recess 404a, 404b, 404c configured to receive a corresponding vertical protrusion 500a, 500b, 500c located on the pump head 1. In FIG. 20c, the pump head 1 is attached to the pump driver 31 but in an unlocked position. In the unlocked position, a front end 510 of the pump head 1 may contact the third support structure 402. By sliding the pump head 1 towards the fourth support structure 402', the pump head is in a locked position. In the locked position, a 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 is in contact with the fourth support structure, at least one recess 404a, 404b, 404c of each of 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, making it impossible to remove the pump head 1 from the pump drive device 31.The pump head 1 is removed from the pump drive 31 by sliding the pump head 1 towards 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 of the first support structure 400. The first sliding recesses 406 of the first support structure 400 are configured to receive the protrusions 500a, 500b, 500c and to 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' of the second support structure 400' is configured to receive the protrusions 500a', 500b', 500c' (not shown) and to allow the pump head 1 to move back and forth from the third support structure 402 and the fourth support structure 402'. Locking means include the protrusions 500a, 500b, 500c, 500a', 500b', 500c', the recesses 404, 404b, 404c, 404a', 404b', 404c' and the sliding recesses 406, 406'.

[0075] 21a-21g show in various views a fifth exemplary embodiment of a quick connect fastener for releasably securing the pump head 1 to the pump drive 31. Similar to the second embodiment shown in FIG. 18, the pump head 1 is to be secured to a support structure in the form of a frame 620 located on the upper part 31′ of the pump drive 31.

[0076] A resilient member 280 is attached to the frame 620. The resilient member 280 has a stop member 204 at its upper end portion. The stop member 204 is configured to move laterally outward from the center of the frame 620 when the depressible member 600 is in the open position. In FIG. 21 the depressible member 600 is shown as being depressible between an open position and a locked position. In the open position, there is no contact between the depressible member 600 and the stop member 204 when the depressible member is depressed. In the open position, a blocking surface 240 is laterally spaced from a corresponding blocking surface 290 of the stop member 204. In the locked position, the blocking surface 240 of the depressible member 600 and the blocking surface 290 of the stop member 204 are in contact. In the locked position, the pump head 1 is prevented from moving away from the pump driver 31. That is, the downwardly inclined surface 224 of the stop member 204 is attached to a corresponding upwardly inclined surface 210 of the pump head 1 .

[0077] In Fig. 21d-g, the upwardly inclined surface 210 of the pump head 1 is provided as a recess in the periphery of the top surface of the pump head. In various exemplary embodiments, the entire periphery of the top surface may be inclined. This inclined surface is used to facilitate removal of the pump head 1 from the pump drive 31 when the depressible member 600 is in the open position. Similarly, the inclined periphery of the bottom surface (not shown) of the pump head 1 is configured to slide against the upwardly inclined surface 222 of the stop member 204 to facilitate assembly of the pump head 1 into the pump drive 31. The pump head 1 can be connected to and disconnected from the pump drive 31 only when the depressible member 600 is in its open position and the stop member 204 can be moved from its position by the elastic member 280. The depressible member 600 may have an axis 604 configured to be movable in a corresponding well 606 in the frame 620. A spring 602 is disposed between a frame 620 and the depressible member 600. In various exemplary embodiments, the movement of the depressible member 600 may be accomplished by at least one electric motor. A locking means includes the depressible member 600, the stop member 204, and the upwardly inclined surface 210.

[0078] The improved arrangement shown in the figures addresses various problems associated with the prior art, in particular, the improved arrangement is more compact and less likely to trap air, thereby improving cleanliness, and provides less pulsating flow over a relatively wide range of flow rates and pressures.

[0079] It will be apparent to those skilled in the art that additions, omissions and modifications to the above-described embodiments are possible without departing from the scope of the invention as claimed. [Explanation of symbols]

[0080] 1 Pump Head 3 Common Entrance 5 common exit 7 Pump Cavity 9 Inlet valve 9' Core 9” outer layer 9a Flexible valve disc 9b Centering stem 9c Outer sealing area 9d Valve stem sealing area 11 Outlet valve 11' Core 11” outer layer 11a Flexible valve disc 11b Centering stem 11c Outer sealing area 11d Valve stem sealing area 13 Movable diaphragm 21 Leak Collector 25 Rotating Device 25a First end 26 Opening 27 Diaphragm Engagement Plate 28 Diaphragm Retaining Plate 28a Recess 31 Pump drive unit 31' upper part 33 Rotating drive shaft, drive shaft 35 Wobble Plate 37 Bearings 41a Collaborative Linkage Functions 41b Collaborative linking functions 61a Entrance Channel 61b Exit Channel 66 Center hole 90 Inlet valve area or outlet valve area 90c valve seat 90d Valve sealing surface 101 Pump Head 101' Pump Head 101” pump head 102 Display 121 Leak Collector 123 Lower exhaust port 125 Secondary Port 126 Pump cavity inlet 130 Pump cavity outlet 161 External Parts 161' External Parts 162 separate channels 162' Separate Channels 163 Pressure Regulating Valve 170 First support structure, first element 171 Second Support Structure, Second Element 172 Flange 173 First protrusion 174 Guidance elements 174' Second prong 175 Auxiliary elastic member 176 Opening 177 First retaining flange 177' Screw 178 Recess 179 Second stop flange 180 Second recess 182 First recess 190 Spring 192 Spring recess 194 Spring protrusion 200 frames 201 Pump Head 202 Rotating cam member 204 Retaining member 206 Cam part 208 Flat Surface Area 210 Upward Slope 220 Bottom of pump head 222 Upward Slope 224 Downward Slope 240 Rear end 270 Handle 272 Rotational Axis 280 Elastic Members 290 Blocking surface 300 Support Structure 301 Pump Head 302 Rotatable Ring 304 Handle 310a Lock recess 310b Lock recess 310c Lock recess 310d Lock recess 320a first inner portion 320b first inner portion 320c first inner portion 320d First inner part 340a Recess 340b Recess 340c recess 340d recess 360a second inner portion 360b second inner portion 360c second inner part 360d Second inner part 400 First support structure, first element 400' second support structure, second element 402 Third Support Structure 402' Fourth Support Structure 404 Recess 404a Vertical recess, recess 404a' recess 404b Vertical recess, recess 404b' Recess 404c Vertical recess, recess 404c' Recess 406 Sliding recess 406' Sliding recess 500a vertical protrusion, protrusion 500b vertical protrusion, protrusion 500c vertical protrusion, protrusion 500a' vertical protrusion, protrusion 500b' vertical protrusion, protrusion 500c' vertical protrusion, protrusion 510 Front 530 Rear end 600 Depressible member 602 Spring 604 Axis 606 well 620 Frame C center

Claims

1. 1. A diaphragm pump for a bioprocessing system, comprising: A pump head (1, 101, 201, 301), Common entrance (3), common exit (5), a plurality of pump cavities (7) each including at least a pair of cooperating one-way valves, the at least a pair of one-way valves including an inlet valve (9) and an outlet valve (11), each of the inlet valves (9) in fluid communication with the common inlet (3) and each of the outlet valves (11) in fluid communication with the common outlet (5), the center of the outlet valve (11) for each pump cavity being positionable over the center of the inlet valve (9) for the same pump cavity when the diaphragm pump is oriented in a use state to inhibit trapped gas; a plurality of movable diaphragms (13) respectively provided in each of said pump cavities (7) for varying the volume of said pump cavities; A pump head (1, 101, 201, 301) including a pump drive (31) configured to transmit motion to a diaphragm (13) of said pump head (1, 101, 201) to achieve a fluid displacement from the common inlet (3) to the common outlet (5) of said pump head (1, 101, 201, 301) as a result of changing the volume of said pump cavity (7); A diaphragm pump comprising:

2. 2. The diaphragm pump of claim 1, wherein the inlet and outlet valves (9, 11) include flexible valve discs (9a, 11a), each disc including a generally central retaining stem (9b, 11b) for holding the valve disc in place.

3. 3. The diaphragm pump of claim 2, wherein the inlet and outlet valves (9, 11) comprise outer sealing areas (9c, 11c) of the flexible valve disc (9a, 11a) configured to seal against at least a portion of a corresponding valve seat (90c) in the pump head (1, 101, 201, 301), the outer sealing areas (9c, 11c) being made of a first material that is softer than a second material of the remaining parts of the inlet and outlet valves (9, 11).

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

5. 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 in the valve stem sealing area (9d, 11d) of the flexible valve disc (9a, 11a) is used as a layer (9", 11") having a predetermined thickness on at least a part of the core (9', 11') comprising the second material.

6. 6. A 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. 7. The diaphragm pump according to claim 1, wherein the movable diaphragm (13) comprises a reinforcing layer and an elastomer layer.

8. The diaphragm pump of claim 7 , wherein the reinforcing layer is embedded in the elastomeric layer.

9. 9. The diaphragm pump of claim 7 or 8, wherein the reinforcing layer comprises a web structure made of a fabric or elastomeric material having a low elasticity compared to the elastomeric layer.

10. 10. The diaphragm pump of claim 8 or 9, wherein the elastomeric layer is oriented to contact a liquid-containing portion of the diaphragm pump.

11. 11. The diaphragm pump according to any one of claims 1 to 10, wherein the pump head (1, 101, 201) further comprises a pivoting device (25) provided at the center (C) of the diaphragm engagement plate (27) of the pump head to obtain a pivot point at the center (C) of the diaphragm engagement plate (27).

12. 12. The diaphragm pump according to claim 1, wherein the pump head (1, 101, 201) further comprises at least one leak collector (21, 121), the at least one leak collector (21, 121) comprising a flexible bellows surrounding the pump cavity (7) and the diaphragm (13) and configured to collect possible leakage from the pump cavity (7).

13. 13. The diaphragm pump of claim 1, wherein the pump drive (31) comprises a rotating drive shaft (33) and a wobble plate (35) connected to the rotating drive shaft (33) at an inclined angle via a bearing (37), the wobble plate (35) configured to couple with the pump head (1, 101, 201, 301) to transmit motion from the rotating drive shaft (33) to the diaphragm (13).

14. 14. The diaphragm pump of claim 13, wherein the pump drive (31) is configured to apply active modulation of pump speed relative to the rotation of the rotating drive shaft (33) to compensate for pump pulsation.

15. 15. The diaphragm pump according to any one of claims 1 to 14, wherein the pump head (1, 101, 201) comprises three or five pump cavities (7) radially distributed around a center (C) of the pump head (1, 101, 201, 301).

16. 16. The diaphragm pump of claim 1, wherein the diaphragm engagement plate (27) of the pump head (1, 101, 201, 301) and the wobble plate (35) of the pump drive (31) have cooperating coupling features (41a, 41b) provided to avoid rotational friction forces between the diaphragm engagement plate and the wobble plate.

17. 17. The diaphragm pump according to any one of the preceding claims, wherein the pump head (1, 101, 201) is a single-use pump head and the pump drive (31) is reusable.

18. 18. The diaphragm pump according to claim 1, wherein the pump head (1, 101, 301) is manufactured from a number of plastic layers connected by diffusion bonding, forming a closed compartment free of seals, the closed compartment comprising at least the inlet and outlet valves (9, 11) and the diaphragm (13) as integral elastomeric functional components.

19. 19. The diaphragm pump of any one of claims 1 to 18, further comprising a quick connect fastener for releasably securing the pump head (1, 101, 301) to the pump drive (31).

20. 20. The diaphragm pump of claim 19, wherein the quick connect fastener is operable between a locked position in which the pump head (1, 101, 301) is locked to the pump drive (31) and an unlocked position in which the pump head (1, 101, 301) is releasable and removable from the pump drive (31).

21. 21. The diaphragm pump of claim 1, wherein the pump drive (1, 101, 301) comprises at least one support structure (170, 171, 200, 300, 400, 400', 402, 402', 620) for limiting movement of the pump head (1) in at least one direction when attached to the pump drive (31).

22. 22. Diaphragm pump according to any one of claims 19 to 21, wherein at least one locking means is movably attached to the pump drive (31).

23. A pump head (1, 101, 201, 301) configured for use in connection with a pump drive (31) of a diaphragm pump for a bioprocessing system, comprising: A common entrance (3); A common exit (5); a plurality of pump cavities (7) each including at least a pair of cooperating one-way valves, said at least a pair of one-way valves including an inlet valve (9) and an outlet valve (11), each said inlet valve (9) in fluid communication with said common inlet (3) and each said outlet valve (11) in fluid communication with said common outlet (5), a center of the outlet valve (11) for each pump cavity being positionable over a center of the inlet valve (9) for the same pump cavity when said diaphragm pump is oriented in a use state to inhibit trapped gas; a respective movable diaphragm (13) in said pump cavity (7) for varying the volume of said pump cavity; A pump head (1, 101, 201, 301) comprising:

24. 24. The pump head (1, 101, 201, 301) of claim 23, wherein the inlet and outlet valves (7, 9) include flexible valve discs, each disc including a generally central retaining stem for holding the valve disc in place.

25. 25. The pump head (1, 101, 201, 301) of claim 23 or 24, further comprising a pivoting device (25) provided at the center (C) of the diaphragm engagement plate (27) of the pump head to obtain a pivot point at the center (C) of the diaphragm engagement plate (27).

26. The pump head (1, 101, 201, 301) according to any one of claims 23 to 25, further comprising at least one leak collector (21, 121), the at least one leak collector (21, 121) including a flexible bellows surrounding the pump cavity (7) and the movable diaphragm (13) and configured to collect possible leakage from the pump cavity (7).

27. 27. The pump head (1, 101, 201, 301) according to any one of claims 23 to 26, wherein the pump head (1, 101, 201) comprises three or five pump cavities (7) radially distributed around a centre (C) of the pump head (1, 101, 201).

28. 28. The pump head (1, 101, 201, 301) according to any one of claims 23 to 27, wherein the pump head (1, 101, 201) is a single-use pump head.

29. 29. A pump head (1, 101, 201, 301) according to any one of claims 23 to 28, wherein the pump head (1, 101, 201) is manufactured from a plurality of plastic layers connected by diffusion bonding, forming a closed compartment free of seals, the closed compartment including at least the inlet and outlet valves (9, 11) and the movable diaphragm (13) as its integral elastomeric functional components.

30. 30. The pump head (1, 101, 201, 301) of any one of claims 23 to 29, further comprising a quick connect fastener for releasably securing the pump head to the pump drive.

31. The pump head (1, 101, 201, 301) of claim 30, wherein the quick connect fastener is operable between a locked position in which the pump head is locked to the pump drive (31) and an unlocked position in which the pump head is releasable and removable from the pump drive (31).

32. A single-use flow path assembly for a bioprocessing system comprising a pump head (1, 101, 201, 301) according to any one of claims 29 to 38 connected to a single-use flow path.

33. 33. The single use flow path assembly of claim 32, wherein the flow path assembly is pre-sterilized.

34. 23. A bioprocessing system comprising a diaphragm pump according to any one of claims 1 to 22.

35. 23. A one-way valve configured for use in a diaphragm pump according to any one of claims 1 to 22, comprising an outer sealing area (9c, 11c) of a flexible valve disc (9a, 11a) configured to seal against at least a portion of a corresponding valve seat (90c) in a pump head (1, 101, 201, 301) of the diaphragm pump, said outer sealing area (9c, 11c) being made of a first material which is softer than a second material of the remainder of the one-way valve.

36. 36. The one-way valve of claim 35, wherein the one-way valve also includes a first, softer material in a valve stem sealing region (9d, 11d) configured to seal against at least a portion of a corresponding valve sealing surface (90d) of the pump head (1, 101, 201, 301).

37. 37. A one-way valve according to claim 35 or 36, wherein the softer material in the outer sealing area (9c, 11c) of the flexible valve disc (9a, 11a) and / or in the valve stem sealing area (9d, 11d) of the flexible valve disc (9a, 11a) is provided as a layer (9", 11") having a predetermined thickness on at least a portion of the core (9', 11') comprising the second material.

38. 38. A one-way valve according to any one of claims 35 to 37, wherein at least a portion of the valve stem (9b, 11b) of the one-way valve has a frusto-conical shape.

39. A movable diaphragm (13) configured for use in a diaphragm pump according to any one of claims 1 to 22, the movable diaphragm (13) comprising a reinforcing layer and an elastomer layer.

40. 40. The movable diaphragm (13) of claim 39, wherein the reinforcing layer is embedded in the elastomeric layer.

41. 41. The movable diaphragm (13) of claim 39 or 40, wherein the reinforcing layer comprises a web structure made of a fabric or elastomeric material having a low elasticity compared to the elastomeric layer.

42. 42. The movable diaphragm (13) according to any one of claims 39 to 41, wherein the elastomeric layer is configured to be in contact with a liquid in the diaphragm pump.

43. 23. A quick connect fastener configured for use with a diaphragm pump as claimed in any one of claims 1 to 22 for releasably securing the pump head (1, 101, 201, 301) to the pump drive (31), wherein at least one locking means arranged on the pump drive is movable relative to the pump drive for locking the pump head to the pump drive.

44. 44. The quick connect fastener of claim 43, wherein at least one locking means is rotatable.

45. 45. A quick connect fastener according to claim 43 or 44, wherein at least one locking means is resilient.

46. 46. ​​The quick connect fastener of claim 45, further comprising at least one means for limiting movement of said resilient locking means.

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