Pressure generating device and detection system including the pressure generating device

Abstract

A pressure generating device includes a tank, a deformable membrane, a driving device, and a connecting unit. The tank has a chamber and includes an opening and a connecting port, both in fluid communication with the chamber. The deformable membrane is configured to seal the opening. The driving device has a driving shaft, one end of which faces the deformable membrane. The connecting unit is configured to couple the driving shaft and the deformable membrane, causing the deformable membrane to change between a flat state and a deformed state under the drive of the driving shaft. A detection system includes the pressure generating device for quality detection of a sample to be tested.

Description

Technical Field

[0001] This invention relates to a pressure generating device, and more particularly to a pressure generating device for detecting the quality of oocytes or embryos and a detection system comprising the pressure generating device. Prior Technology

[0002] In vitro fertilization (IVF) is an option for infertile couples to achieve pregnancy. During IVF, after stimulating the mother's ovaries with follicle-stimulating hormone (FSH), several oocytes are retrieved from the ovaries and fertilized in vitro. One or more of these fertilized oocytes can then be transferred back into the mother's uterus. In some cases, the fertilized oocytes may further develop into embryos in vitro, and one or more embryos are then transferred back into the mother's uterus. To improve the live birth rate during IVF, it is necessary to select high-quality fertilized eggs or embryos for transfer back into the mother's uterus. Summary of the Invention

[0003] Therefore, one of the objectives of this invention is to provide a pressure generating device for determining the quality of oocytes or embryos and a detection system including the pressure generating device.

[0004] The pressure generating device of a first aspect of the present invention includes a tank, a deformable membrane, a driving device, and a connecting unit. The tank has a chamber and includes an opening and a connecting port, both of which are in fluid communication with the chamber. The deformable membrane is configured to seal the opening and can change shape between a flat state and a deformable state. The driving device is disposed in the tank and includes a motor body and a drive shaft. The drive shaft has a first shaft end positioned towards the deformable membrane. The drive shaft is driven by the motor body and moves between a distal position and a proximal position, where the first shaft end is away from the motor body at the distal position and close to the motor body at the proximal position. The connecting unit is configured to couple the first shaft end and the deformable membrane, so that the deformable membrane is driven by the drive shaft to change between the flat state and the deformable state. In the flat state, the first shaft end is in one of the distal position and the proximal position, and in the deformable state, the first shaft end is in the other of the distal position and the proximal position. Therefore, when the deformable membrane changes from one of the flat state and the deformable state to the other of the flat state and the deformable state, a predetermined pressure is generated through the communication port.

[0005] A second aspect of the present invention provides a detection system for detecting the quality of a sample, including an oocyte or an embryo, comprising a pressure generating device, a micropipette for aspirating the sample, and a connecting tube. The connecting tube is configured to connect the inlet of the tank to the micropipette to apply the predetermined pressure to the sample. Simple Explanation of the Diagram

[0006] Other features and effects of the present invention will be clearly presented in the embodiments with reference to the drawings, wherein: Figure 1 is a schematic diagram illustrating a first embodiment of the pressure generating device of the present invention; Figure 2 is a schematic diagram of a pressure generating device similar to Figure 1 but in a pressure increasing state; Figure 3 is a schematic diagram illustrating a second embodiment of the pressure generating device of the present invention; Figure 4 is a schematic diagram of a pressure generating device similar to Figure 3 but in a pressure increasing state; Figure 5 is a perspective view illustrating a third embodiment of the pressure generating device of the present invention; Figure 6 is an exploded perspective view illustrating some components of the pressure generating device shown in Figure 5; Figure 7 is an exploded perspective view illustrating one side shell of a tank, a deformable membrane, and a connecting unit of the pressure generating device shown in Figure 5; Figure 8 is an exploded perspective view similar to Figure 7 but in the opposite direction, illustrating the side shell, the deformable membrane, and the connecting unit of the tank. Figure 9 is an exploded perspective view illustrating a drive device of the pressure generating device shown in Figure 5, a connecting sleeve of the connecting unit, and a marking element; Figure 10 is a schematic diagram illustrating the main parts of an embodiment of the detection system of the present invention; Figure 11 is a schematic diagram illustrating an embodiment of a microscope of the detection system; Figure 12 is a diagram illustrating the testing process used in some embodiments to determine the quality of a sample to be tested; Figures 13 and 14 are microscopic images of oocytes before and after a predetermined negative pressure provided by the pressure generating device of the detection system; and Figure 15 is a diagram illustrating another test procedure used in some embodiments to determine the quality of a sample to be tested. Implementation

[0007] Before describing the invention in more detail, it should be noted that, where appropriate, the end portions of the symbols are repeated in the drawings to indicate corresponding or similar elements, which may optionally have similar features.

[0008] It should be noted that, for clarity, spatially relative terms such as “top,” “bottom,” “higher,” “lower,” “above,” “above,” “above,” “over,” “downward,” and “upward” may be used in the following disclosure, while referring to the features shown in the diagrams. These features may be oriented differently (e.g., rotated 90 degrees or otherwise) and may accordingly explain the spatially related terms used herein.

[0009] It should be noted that the drawings are for illustrative purposes only and are not drawn to scale, and do not represent the actual dimensions or actual relative dimensions of the components of the device or system of the present invention.

[0010] Figures 1 and 2 respectively illustrate the pressure generating device 1 according to a first embodiment of the present invention. The pressure generating device 1 is used to generate pressure on a sample (S) to be tested via a micropipette 3 (see Figures 13 and 14). The sample (S) to be tested can be an oocyte (e.g., a fertilized or unfertilized mammalian oocyte) or an embryo (e.g., a mammalian embryo). Based on the aspiration depth (D) of the sample (S) to be tested (see Figure 14) and other factors (e.g., morphology observed using a microscope 5 shown in Figure 11), the quality of the sample (S) to be tested can be determined.

[0011] The pressure generating device 1 includes a tank 10, a deformable membrane 20, a driving device 30, and a connecting unit 40.

[0012] The tank 10 has a chamber 100 and includes an opening 101 and a connecting port 102, both of which are in fluid communication with the chamber 100. The deformable membrane 20 is configured to seal the opening 101 and can change shape between a flat state and a deformable state. The drive device 30 can be disposed in the tank 10 by any possible component and includes a motor body 31 and a drive shaft 32. The drive shaft 32 has a first shaft end 321 positioned toward the deformable membrane 20. The drive shaft 32 is driven by the motor body 31 and moves between a distal position and a proximal position, where the first shaft end 321 is away from the motor body 31 and where the first shaft end 321 is close to the motor body 31. The connecting unit 40 is configured to couple the first shaft end 321 and the deformable membrane 20, so that the deformable membrane 20 is driven by the drive shaft 32 to change between a flat state and a deformable state. In the flat state, the first shaft end 321 is in one of the distal position and the proximal position; in the deformable state, the first shaft end 321 is in the other of the distal position and the proximal position. Thus, when the deformable membrane 20 changes from one of the flat state and the deformable state to the other of the flat state and the deformable state, a predetermined pressure is generated through the communication port 102.

[0013] In the first embodiment, in the flat state shown in FIG1, the first shaft end 321 is located at the proximal position; in the deformed state shown in FIG2, the first shaft end 321 is located at the distal position. Accordingly, when the deformable membrane 20 changes from one of the flat state and the deformed state to the other of the flat state and the deformed state, a predetermined pressure is generated through the communication port 102.

[0014] In the first embodiment, in response to the movement of the drive shaft 32 from the proximal position (see FIG. 1) to the distal position (see FIG. 2), the deformable membrane 20 is deformed inward by the force exerted by the connecting unit 40, causing the deformable membrane 20 to change from the flat state to the deformed state. As the deformable membrane 20 deforms, the chamber 100 changes to a pressure-increasing state. In this state, if the deformable membrane 20 returns from the deformed state to the flat state, the predetermined pressure can be generated from the communication port 102.

[0015] In some embodiments, the tank 10 may be made of metal, alloy, plastic, other suitable airtight rigid material or a combination thereof. In some embodiments, the deformable membrane 20 may be made of silicone resin, polymer, fabric, any suitable airtight flexible material or a combination thereof.

[0016] Figures 3 and 4 illustrate a second embodiment of the pressure generating device 1 of the present invention. This second embodiment is similar to the first embodiment, except that in the second embodiment, the deformable membrane 20 deforms outwards in its deformed state. Specifically, in the second embodiment, the connecting unit 40 is fixed to the deformable membrane 20. When the drive shaft 32 is in the remote position, the deformable membrane 20 can remain in the flat state. In response to the drive shaft 32 moving from the distal position (see Figure 3) to the proximal position (see Figure 4), the deformable membrane 20 is pulled outwards by the connecting unit 40, causing the deformable membrane 20 to change from the flat state to the deformed state. As the deformable membrane 20 deforms, the chamber 100 changes to a depressurized state, thus generating the predetermined pressure from the communication port 102.

[0017] Figures 5 to 9 illustrate a third embodiment of the pressure generating device 1 of the present invention. This third embodiment is similar to the first and second embodiments, except that in the third embodiment, the tank 10, the deformable membrane 20, the driving device 30, and the connecting unit 40 are further shown in implementation details.

[0018] Referring to Figures 5 and 6, the tank 10 includes a main shell 11 and a side shell 12. The main shell 11 has the chamber 100 and includes the opening 101 and the communication port 102. The side shell 12 is detachably disposed on the main shell 11, allowing the deformable membrane 20 to be fixed between the main shell 11 and the side shell 12 to seal the opening 101.

[0019] In some embodiments, the main housing 11 extends along a longitudinal axis L and terminates at a closed end 111 and a connecting end 112 forming the opening 101. In some embodiments, the main housing 11 forms two connecting ports 102.

[0020] Referring to Figures 7 and 8, in some embodiments, the side shell 12 includes a side shell body 121 and a flange body 125. The side shell body 121 has a distal end 122 and a proximal end 123 opposite to the distal end 122, forming a channel 124 extending from the distal end 122 to the proximal end 123. The flange body 125 extends radially outward from the proximal end 123 of the side shell body 121 and is detachably disposed on the main shell 11. In some embodiments, the deformable membrane 20 is maintained in a flat state by a holding force provided between the main shell 11 and the side shell 12.

[0021] In some embodiments, the tank 10 further includes two connecting rods 142. Each connecting rod 142 has one end that inserts into a corresponding communication port 102. In this way, the tank 10 can form fluid communication with a connecting pipe 4 (see Figures 1 to 4, Figure 10) via one of the connecting rods 142. Each connecting rod 142 has a valve (not shown) disposed thereon, which can be switched between a first state and a second state. In the first state, one of the connecting rods 142 is in an open state, allowing the chamber 100 to be in fluid communication with the connecting pipe 4; in the second state, one of the connecting rods 142 is in a closed state, blocking the communication between the chamber 100 and the connecting pipe 4.

[0022] In some embodiments, a plurality of fasteners 126 are configured to pass through the flange body 125 and the deformable membrane 20 and extend into the connection end 112 of the main housing 11 to secure the side housing 12 to the main housing 11.

[0023] As shown in Figures 5 and 9, the drive device 30 is disposed in the tank 10. In some embodiments, the motor body 31 is immovably disposed in the side shell 12; the drive shaft 32 extends along a central axis (A) passing through the motor body 31 and is driven by the motor body 31 to move closer to or further away from the deformable membrane 20 along the central axis (A), causing the deformable membrane 20 to switch between the flat state and the deformable state. In some embodiments, the central axis (A) is aligned with the longitudinal axis (L). In some embodiments, the drive device 30 is a linear motor, and the drive shaft 32 does not rotate about the central axis (A) when driven to move along it. In some other embodiments, the drive device 30 is a stepper motor, and the drive shaft 32 rotates about the central axis (A) when driven to move along it.

[0024] Referring to Figure 9, in some embodiments, the motor body 31 has an interior 311, an exterior 312, and a flange portion 313. The interior 311 is received in the channel 124 of the side housing body 121. The exterior 312 extends from the interior 311 in a direction away from the main housing 11 and is disposed outside the side housing body 121. The flange portion 313 protrudes radially from the exterior 312 and is detachably secured to the distal end 122 of the side housing body 121 by fasteners 314.

[0025] In some embodiments, the drive shaft 32 also has a second shaft end 322 on the shaft (A) opposite to the first shaft end 321. The first shaft end 321 and the second shaft end 322 are located on opposite sides of the motor body 31.

[0026] Referring to Figures 7 and 8, in some embodiments, the connecting unit 40 includes a connecting sleeve 41, a bearing sleeve 42, and a bearing cover 43.

[0027] The connecting sleeve 41 is coupled to the first shaft end 321 of the drive shaft 32, allowing the connecting sleeve 41 to move along the axis A with the drive shaft 32. The connecting sleeve 41 has a first sleeve portion 411, a second sleeve portion 412, and a shoulder surface 413. The second sleeve portion 412 has an outer diameter larger than that of the first sleeve portion 411. The shoulder surface 413 is located between the first sleeve portion 411 and the second sleeve portion 412. In some embodiments, as shown in FIG9, the connecting sleeve 41 forms a through hole 414, and the first shaft end 321 is non-rotatably fixed to the through hole 414 by a fastener 415.

[0028] The bearing sleeve 42 is fitted onto the second sleeve portion 412 in a perfectly sized manner, allowing the bearing sleeve 42 to move along the shaft (A) with the connecting sleeve 41 and be positioned between the connecting sleeve 41 and the bearing cover 43. The bearing sleeve 42 has a first sleeve end 421 and a second sleeve end 422 opposite to the first sleeve end 421. In some embodiments, a plurality of bearing balls 423 are formed in the second sleeve end 422 and spaced apart from each other at a certain angle around the shaft (A).

[0029] The bearing cap 43 has a connecting portion 431 and a mounting portion 432. The connecting portion 431 forms a groove 4311 configured to engage with the second sleeve edge 422, allowing the bearing cap 43 to move along the shaft (A) with the bearing sleeve 42. The mounting portion 432 is opposite to the connecting portion 431 on the shaft (A) and is fixed to a first surface 201 of the deformable membrane 20 to transmit the applied force from the drive shaft 32 to the deformable membrane 20.

[0030] In some embodiments, the deformable membrane 20 forms a perforation 200, and the connecting unit 40 further includes a fastener 44. The fastener 44 has an enlarged head 441 and a fastening rod 442. The enlarged head 441 is disposed on a second surface 202 of the deformable membrane 20 opposite to the first surface 201. The fastening rod 442 passes through the enlarged head 441 through the perforation 200 of the deformable membrane 20 and terminates at a rod end 443. The rod end 443 is fitted into a hole 433 formed in the mounting portion 432 of the bearing cap 43, thereby fixing the deformable membrane 20 to the bearing cap 43 by means of the fastener 44.

[0031] In some embodiments, the connecting unit 40 further includes a first washer 45 and a second washer 46. The first washer 45 is disposed between the mounting portion 432 and the first surface 201 of the deformable membrane 20. The second washer 46 is disposed between the enlarged head 441 and the second surface 202 of the deformable membrane 20. In some embodiments, to enhance the torque transmitted from the drive shaft 32 to the deformable membrane 20, the first washer 45 and the second washer 46 are made of a deformable material. Examples of such deformable materials may be similar to the material forming the deformable membrane 20; implementation details are omitted for brevity.

[0032] Referring to Figures 1, 2, 5 to 9, in some embodiments, the deformable membrane 20 is deformed inward in this deformed state. In other words, in response to the drive shaft 32 moving from the proximal position to the distal position, the bearing cap 43 is moved toward the chamber 100 and pressed against the deformable membrane 20 by the first shaft end 321 through the connecting sleeve 41 and the bearing sleeve 42, thereby forcing the deformable membrane 20 to deform into this deformed state against the holding force from the main housing 11 and the side housing 12. In response to the drive shaft 32 moving from the distal position (see Figure 2) to the proximal position (see Figure 1), the bearing cap 43 is driven to move away from the chamber 100, causing the deformable membrane 20 to return to the flat state by the holding force, thereby generating the predetermined pressure (e.g., predetermined negative pressure) in the communication port 102 (or one of the communication ports 102 shown in Figure 6).

[0033] Referring to Figures 3 through 9, in some other embodiments, the deformable membrane 20 deforms outward in this deformed state. In this case, the drive device 30 is a linear motor, and the connecting sleeve 41, the bearing sleeve 42, and the bearing cover 43 are fixed together. In some embodiments, each pair of adjacent members of the connecting sleeve 41, the bearing sleeve 42, and the bearing cover 43 is dimensionally fitted together. In some other embodiments, an adhesive agent is applied between each pair of adjacent members of the connecting sleeve 41, the bearing sleeve 42, and the bearing cover 43. Specifically, in response to the drive shaft 32 moving from the distal position (see FIG. 3) to the proximal position (see FIG. 4), the deformable membrane 20 is pulled by the connecting unit 40 to resist the holding force between the main housing 11 and the side housing 12 and deform outward to the deformed state, causing the communication port 102 or one of the communication ports 102 shown in FIG. 6 to generate the predetermined pressure (e.g., predetermined negative pressure). In response to the drive shaft 32 moving from the proximal position to the distal position, the connecting unit 40 moves toward the chamber 100, causing the deformable membrane 20 to return to the flat state by the holding force.

[0034] In some embodiments, the deformable membrane 20 has a Shore hardness between 0 and 0. A) Hardness ranges up to 100 Shore hardness, for example, 0 Shore hardness to 10 Shore hardness, 5 Shore hardness to 15 Shore hardness, 10 Shore hardness to 20 Shore hardness, 15 Shore hardness to 25 Shore hardness, 20 Shore hardness to 30 Shore hardness, 25 Shore hardness to 35 Shore hardness, 30 Shore hardness to 40 Shore hardness, 35 Shore hardness to 45 Shore hardness, 40 Shore hardness to 50 Shore hardness, 45 Shore hardness to 55 Shore hardness, 50 Shore hardness to 60 Shore hardness, 55 Shore hardness to 65 Shore hardness, 60 Shore hardness to 70 Shore hardness, 65 Shore hardness to 75 Shore hardness, 70 Shore hardness to 80 Shore hardness, 75 Shore hardness to 85 Shore hardness, 80 Shore hardness to 90 Shore hardness, 85 Shore hardness to 95 Shore hardness, or 90 Shore hardness to 100 Shore hardness. The drive unit 30 is configured to provide a thrust ranging from 100 grams (g) to 1000 grams, for example, 100 grams to 200 grams, 150 grams to 250 grams, 200 grams to 300 grams, 250 grams to 350 grams, 300 grams to 400 grams, 350 grams to 450 grams, 400 grams to 500 grams, 450 grams to 550 grams, 500 grams to 600 grams, 550 grams to 650 grams, 600 grams to 700 grams, 650 grams to 750 grams, 700 grams to 800 grams, 750 grams to 850 grams, 800 grams to 900 grams, 850 grams to 950 grams, or 900 grams to 1000 grams. The stroke range of the drive device 30 is between 3 mm and 50 mm, for example, 3 mm to 15 mm, 9 mm to 21 mm, 15 mm to 27 mm, 21 mm to 33 mm, 27 mm to 39 mm, 33 mm to 45 mm, or 39 mm to 50 mm.

[0035] The stroke and thrust configuration of the drive device 30 depend on the required degree of deformation and hardness of the deformable membrane 20, respectively. When the required stroke of the drive device 30 is relatively long and the hardness of the deformable membrane is relatively low, the operation of the drive device 30 will be relatively easy (i.e., the required thrust of the drive device 30 will be relatively small). When the hardness of the deformable membrane 20 increases, if the required stroke of the drive device 30 does not decrease, the required thrust of the drive device 30 will increase.

[0036] In some embodiments, the volume of the main housing 11 ranges from 1 cubic centimeter (cm³) to 50 cubic centimeters, for example, 1 cubic centimeter to 10 cubic centimeters, 5 cubic centimeters to 15 cubic centimeters, 10 cubic centimeters to 20 cubic centimeters, 15 cubic centimeters to 25 cubic centimeters, 20 cubic centimeters to 30 cubic centimeters, 25 cubic centimeters to 35 cubic centimeters, 30 cubic centimeters to 40 cubic centimeters, 35 cubic centimeters to 45 cubic centimeters, or 40 cubic centimeters to 50 cubic centimeters.

[0037] In some embodiments, the pressure generating device 1 further includes a light sensor 80, which is immobile relative to the tank 10 but can detect the displacement of the drive shaft 32. In some embodiments, a circuit board 81 is disposed on the side shell body 121, and the light sensor 80 is disposed on the circuit board 81 and electrically connected to the circuit on the circuit board 81.

[0038] Referring to Figures 5 to 9, in some embodiments, the pressure generating device 1 further includes a flag piece 90. The flag piece 90 is disposed at the second shaft end 322 of the drive shaft 32, allowing the flag piece 90 to move with the drive shaft 32. It has multiple detectable positions that can be detected by the photosensor 80 for determining the displacement of the drive shaft 32. In some embodiments, the flag piece 90 is fixed to the second shaft end 322 by a fastener 91.

[0039] Figure 10 shows the main components of a detection system 2 for detecting the quality of a sample (S, see Figures 13 and 14) according to this embodiment. The detection system 2 includes a pressure generating device 1 (one connecting rod 142 is in the open state and the other connecting rod 142 is in the closed state), a micropipette 3 for aspirating the sample (S) (see Figures 13 and 14), and a connecting tube 4 connecting one of the ports 102 of the tank 10 and the micropipette 3 (via the connecting rod 142) to apply a predetermined pressure (e.g., a predetermined negative pressure) generated by the pressure generating device 1 to the sample (S). In some embodiments, the detection system 2 may include the pressure generating device 1 (with both connecting rods 142 in the open state), two micropipettes 3 (only one is shown in Figures 13 and 14), and two connecting tubes 4 (only one is shown in Figure 10). Thus, the predetermined pressure generated by the pressure generating device 1 can be applied to two test samples (S) (only one is shown) via the connecting rods 142. In the following description, the communication port 102, the connecting rods 142, the micropipettes 3, and the connecting tubes 4 will all be described in singular form.

[0040] In some embodiments, the inner diameter of the micropipette 3 ranges from about 10 micrometers to 100 micrometers (e.g., about 40 micrometers to 70 micrometers).

[0041] In some embodiments, the pressure generating device 1 generates a pressure of about 0.5 psi to about -0.5 psi at a suction port 301 of the micropipette 3. For example, the pressure generated at the suction port 301 of the micropipette 3 can vary from about -0.03 psi to about -0.5 psi, from about 0.03 psi to about -0.5 psi, from about 0.03 psi to about 0.5 psi, or from about -0.03 psi to about 0.5 psi.

[0042] Referring to Figures 10, 11, 13, and 14, in some embodiments, the detection system 2 further includes a microscope 5 and an injection holder 18. The microscope 5 is used to monitor the sample (S) to be tested and the aspiration port 301 of the micropipette 3. Specifically, the sample (S) to be tested is placed on a culture dish 501 of the microscope 5, and the injection holder 18 is connected between the connecting tube 4 and the micropipette 3. During operation, the aspiration port 301 of the micropipette 3 is fixed by the injection holder 18 and placed on the culture dish 501 of the microscope 5 to facilitate the retention and / or aspiration of the sample (S) to be tested on the culture dish 501 by the aspiration port 301 of the micropipette 3.

[0043] In some embodiments, the connecting tube 4 includes a first tube section 401 connected to the communication port 102 of the tank 10, and a second tube section 402 connected to the micropipette 3 via the injection holder 18. The first tube section 401 and the second tube section 402 are connected by a regulating valve 15 to regulate the pressure generated at the suction port 301 of the micropipette 3. In some embodiments, the regulating valve 15 is a solenoid valve.

[0044] In some embodiments, the detection system 2 further includes a branch pipe 403 connected to the first pipe segment 401, the branch pipe 403 having an exhaust port 17 located on the opposite side of the first pipe segment 401. Furthermore, an exhaust valve 16 is connected to the branch pipe 403, the branch pipe 403 controlling the fluid communication between the chamber 100 and the exhaust port 17. Specifically, when the exhaust valve 16 is open, the exhaust port 17 is in fluid communication with the chamber 100; when the exhaust valve 16 is fully closed, the exhaust port 17 is not in fluid communication with the chamber 100. Therefore, when the exhaust valve 16 is open, the pressure inside the chamber 100 is allowed to return to atmospheric pressure. In some embodiments, the exhaust valve 16 is a solenoid valve.

[0045] Figure 12 shows a diagram illustrating a test procedure for determining the quality of the sample (S) according to some embodiments. The test procedure presented in Figure 12 will be explained with reference to Figures 10, 13, and 14. In the test procedure shown in Figure 12, the regulating valve 15 is continuously open.

[0046] Referring to Figures 10 and 12, initially, the exhaust valve 16 is completely closed, the pressure within the chamber 100 is adjusted and maintained at the initial pressure (e.g., slightly positive or negative), and the position of the drive shaft 32 is also moved to allow the deformable membrane 20 to remain in its initial state. For example, when the deformable membrane 20 deforms inward (as shown in the embodiments of Figures 1 and 2), the initial state of the deformable membrane 20 is the deformed state (see Figure 2); while when the deformable membrane 20 deforms outward (e.g., as shown in the embodiments of Figures 3 and 4), the initial state of the deformable membrane 20 is the flat state (see Figure 3). As shown in Figure 12, based on the initial pressure of the chamber 100, a small positive pressure (P h) (e.g., about 0.01 ± 10% psi) is generated at the suction port 301 of the micropipette 3 and maintained for a period of time (th), thus maintaining the sample (S) being drawn into the suction port 301 of the micropipette 3, but preventing it from being drawn into the micropipette 3 (see Figure 13). Then, by activating the drive device 30, the deformable membrane 20 is deformed, causing the pressure at the communication port 102 to decrease continuously for a period of time (tg) (e.g., 2 ± 10% sec) to reach the predetermined pressure (e.g., a predetermined negative pressure). Simultaneously, the suction pressure generated at the suction port 301 of the micropipette 3 is gradually reduced to a stress pressure (Ps) (e.g., -0.1 ± 10% psi). This stress pressure (Ps) is maintained for a period of time (ts) (e.g., 1 ± 10% sec), and during this stage, as shown in the microscope image in FIG14, a computer program (not shown) is used to determine a suction depth (D) of the sample (S) to be tested. Finally, the drive device 30 is further activated to continuously increase the pressure within the chamber 100 for a period of time (tr), causing the deformable membrane 20 to return to its initial state. Afterwards, the exhaust valve 16 is opened, allowing the pressure within the chamber 100 to return to atmospheric pressure through the exhaust port 17. Please note that the pressure within the chamber 100 is gradually increased to prevent the sample (S) from being blown away from the micropipette 3. In some other embodiments, the pressure (Ph) generated at the aspiration port 301 of the micropipette 3 may be maintained at a slightly negative pressure (e.g., -0.01 ± 10% psi) for a period of time (e.g., 2 ± 10% seconds) before being reduced to the stress pressure (Ps) and adsorbing the sample (S).

[0047] During the test shown in Figure 12, the drive shaft 32 can be driven to move between the proximal position and the distal position.

[0048] In some embodiments where the deformable membrane 20 deforms inward in the deformed state (e.g., the embodiments shown in FIG1 and FIG2), (i) during time (th), the drive shaft 32 is at the distal position and the deformable membrane 20 is in the deformed state (see FIG2); (ii) during time (ts), the drive shaft 32 is at the proximal position and the deformable membrane 20 is in the flat state (see FIG1).

[0049] In some other embodiments where the deformable membrane 20 deforms outward in a deformed state (e.g., the embodiments shown in Figures 3 and 4), (i) during time (th), the drive shaft 32 is in the distal position and the deformable membrane 20 is in the flat state (see Figure 3); (ii) during time (ts), the drive shaft 32 is in the proximal position and the deformable membrane 20 is in the deformed state (see Figure 4).

[0050] Figure 15 is a diagram of another test procedure for determining the quality of the sample (S) according to some embodiments. The test procedure shown in Figure 15 will be described with reference to Figures 10, 13 and 14. In the test procedure shown in Figure 15, the regulating valve 15 is switched to regulate the pressure generated at the suction port 301 of the micropipette 3.

[0051] Referring to Figures 10 and 15, at the start of the test, the exhaust valve 16 and the regulating valve 15 are fully closed, and the pressure inside the chamber 100 is regulated and maintained at the initial pressure (e.g., a low positive pressure). At this time, the position of the drive shaft 32 is also moved to keep the deformable membrane 20 in its initial state. For example, when the deformable membrane 20 deforms inward (as shown in the embodiments of Figures 1 and 2), the initial state of the deformable membrane 20 is the deformed state (see Figure 2); while when the deformable membrane 20 deforms outward (e.g., as shown in the embodiments of Figures 3 and 4), the initial state of the deformable membrane 20 is the flat state (see Figure 3). Based on the initial pressure of the chamber 100, by opening the regulating valve 15, a slight positive pressure (P h) (e.g., about 0.01 ± 10% psi) is generated at the suction port 301 of the micropipette 3 and maintained for a period of time (th) (see Figure 15). Thus, the sample (S) to be tested remains at the suction port 301 of the micropipette 3 but is not drawn into the micropipette 3 (see Figure 13). Then, the regulating valve 15 is closed, and the deformable membrane 20 is deformed by activating the drive device 30, causing the pressure inside the chamber 100 to continuously decrease for a period of time (tg) (e.g., 3 ± 10% sec) to reach the preset suction pressure (P n) (e.g., -0.13 ± 10% psi). This suction pressure (P n) is maintained for a period of time (ta) (e.g., 2 ± 10% sec). Then, over a period of time (ts) (e.g., 4 ± 10% psi), the pressure within the chamber 100 is slightly increased and maintained at the stress pressure (Ps) (e.g., -0.1 ± 10% psi) by slightly or fully opening the regulating valve 15, while the suction pressure generated by the suction port 301 of the micropipette 3 is substantially equal to the stress pressure (Ps). During this stage (i.e., the sample (S) under stress pressure (Ps)), as shown in the microscope image in Figure 14, the suction depth (D) of the sample (S) is determined using a computer program (not shown). Finally, the drive device 30 is further driven to continuously increase the pressure within the chamber 100 for a period of time (tr), allowing the deformable membrane 20 to return to its initial state. Afterward, the exhaust valve 16 is opened, allowing the pressure within the chamber 100 to return to atmospheric pressure through the exhaust port 17. It should be noted that the pressure within the chamber 100 is increased gradually to avoid blowing the sample (S) away from the micropipette 3. In some other embodiments, the pressure (P h) generated at the suction port 301 of the micropipette 3 can be maintained at a slightly negative pressure (e.g., -0.01 ± 10% psi) for a period of time (e.g., 2 ± 10% seconds) before being reduced to a preset suction pressure (P n) and adsorbing the sample to be tested (S).

[0052] During the test shown in Figure 15, the drive shaft 32 can be driven to move between the proximal position and the distal position.

[0053] In some embodiments where the deformable membrane 20 is deformed inward in a deformed state (e.g., the embodiments shown in FIG1 and FIG2), (i) during time (th), the drive shaft 32 is in the distal position and the deformable membrane 20 is in a deformed state (see FIG2); (ii) during time (ta, ts), the drive shaft 32 is in the proximal position and the deformable membrane 20 is in the flat state.

[0054] In some other embodiments where the deformable membrane 20 deforms outward in the deformed state (e.g., the embodiments shown in FIG3 and FIG4), (i) during time (th), the drive shaft 32 is in the distal position and the deformable membrane 20 is in the flat state (see FIG3); (ii) during time (ta, ts), the drive shaft 32 is in the proximal position and the deformable membrane 20 is in the deformed state (see FIG4).

[0055] By incorporating the detection system 2, which includes the pressure generating device 1, suction pressure can be generated at the suction port 301 of the micropipette 3 to draw up the sample (S) to be tested. Based on the suction depth (D) of the sample (S), the quality of the sample (S) can be determined. For example, a sample (S) with a relatively small suction depth (D) may have better quality. Furthermore, because the suction pressure generated by the pressure generating device 1 is relatively small, the sample (S) is less likely to be damaged during the test, and a qualified sample (S) can be returned to the mother to achieve a successful pregnancy.

[0056] In the foregoing description, numerous specific details have been set forth for illustrative purposes to provide a thorough understanding of the embodiments. However, it will be apparent to those skilled in the art that one or more other embodiments may be practiced without some of these specific details. It should also be understood that references throughout this specification to "an embodiment," "an embodiment," embodiments indicated by markings, etc., imply that specific features, structures, or characteristics may be included in practice. It should also be understood that in the foregoing description, for the purpose of simplifying disclosure and aiding understanding of various aspects of the invention, various features are sometimes combined in a single embodiment, drawing, or description thereof. This does not imply that each of these functions needs to be implemented in the presence of all other functions. In other words, in any disclosed embodiment, when the implementation of one or more features or specific details does not affect the implementation of another one or more features or specific details, said one or more features or specific details may be isolated and implemented independently without said other one or more features or specific details. It should also be noted that in carrying out the invention, where appropriate, one or more features or specific details from one embodiment may be implemented together with one or more features or specific details from another embodiment.

[0057] While the invention has been described in conjunction with what are considered exemplary embodiments, it should be understood that the invention is not limited to the disclosed embodiments, but is intended to cover the spirit and scope of the most broad interpretation of the various configurations included therein, in order to cover all such modifications and equivalent arrangements.

[0058] 1: Pressure generating device 10: Tank 11: Main shell 111: Closed end 112: Connection end 12: Side shell 121: Side shell body 122: Remote 123: Proximal end 124: Channel 125: Flange body 126: Fasteners 142: Connecting rod 100: Chamber 101: Opening 102: Connecting Port 20: Deformable membrane 200: Perforation 201: First Surface 30: Drive unit 31: Motor body 311: Internal 312: External 313: Flange section 314: Fasteners 32: Drive shaft 321: First shaft end 322: Second shaft end 40: Connection Unit 41: Connecting sleeve 411: First sleeve section 412: Second sleeve section 413: Shoulder 414: Through hole 415: Fasteners 42: Bearing sleeve 421: The First Set of Edges 422: Second set of edges 423: Bearing Balls 43: Bearing cover 431: Joint 4311: Groove 432: Installation Department 433: Hole 44: Fasteners 441: Enlarged head 442: Fastening rod 443: End of rod 45: First washer 46: Second washer 80: Light sensor 81: Circuit Board 90: Markings 91: Fasteners 2: Detection System 3: Micropipettes 301: Suction Port 4: Connecting pipe 401: First Pipe Section 402: Second Pipe Section 403: Branch pipe 5: Microscope 501: Petri dish 15: Control valve 16: Exhaust valve 17: Exhaust port 18: Injection stand L: Vertical axis A: Axle S: Sample to be tested Ph: Pressure Ps: Stress pressure Pn: Inhalation pressure th, tg, ta, ts, tr: time D: Suction depth

Claims

1. A pressure generating device, comprising: a tank having a chamber and including an opening and a connecting port, both the opening and the connecting port being in fluid communication with the chamber; a deformable membrane configured to seal the opening and capable of changing shape between a flat state and a deformable state; a driving device disposed in the tank and including a motor body and a drive shaft, the drive shaft having a first shaft end configured to face the deformable membrane, the drive shaft being driven by the motor body to move between a distal position and a proximal position, wherein at the distal position the first shaft end is away from the motor body, and at the proximal position the first shaft end is close to the motor body; A connecting unit is configured to couple the first shaft end and the deformable membrane, such that the deformable membrane is driven by the drive shaft to change between a flat state and a deformable state. In the flat state, the first shaft end is in one of a distal position and a proximal position, and in the deformable state, the first shaft end is in the other of a distal position and a proximal position. Therefore, when the deformable membrane changes from one of the flat state and the deformable state to the other of the flat state and the deformable state, a predetermined pressure is generated through the communication port; and a photosensor that cannot move relative to the groove but can detect the displacement of the drive shaft.

2. The pressure generating device as described in claim 1, wherein, In this deformable state, the deformable membrane deforms inward.

3. The pressure generating device as described in claim 1, wherein, In this deformable state, the deformable membrane deforms outward.

4. The pressure generating device as described in claim 1, wherein, The tank includes: a main shell having the chamber and including the opening and the communication port; and a side shell detachably disposed on the main shell, allowing the deformable membrane to be fixed between the main shell and the side shell to seal the opening; a motor body immovably disposed on the side shell; and a drive shaft extending along a central axis and driven by the motor body to move closer to or further away from the deformable membrane, causing the deformable membrane to switch between a flat state and a deformed state.

5. The pressure generating device as described in claim 4, wherein, The main housing extends along a longitudinal axis and terminates at a closed end and a connecting end forming the opening.

6. The pressure generating device as described in claim 4 or 5, wherein, The side housing includes: a side housing body having a distal end and a proximal end opposite to the distal end, and forming a channel extending from the distal end to the proximal end; and a flange body extending radially outward from the proximal end of the side housing body and detachably disposed in the main housing; the motor body includes: an interior received in the channel of the side housing body; an exterior extending from the interior in a direction away from the main housing and disposed outside the side housing body; and a flange portion protruding radially from the exterior and detachably fixed to the distal end of the side housing body.

7. The pressure generating device as described in claim 1 or 4, wherein, The connecting unit includes: a connecting sleeve coupled to the first shaft end of the drive shaft, allowing the connecting sleeve to move with the drive shaft; the connecting sleeve having a first sleeve portion, a second sleeve portion, and a shoulder surface; the second sleeve portion having an outer diameter larger than that of the first sleeve portion; and the shoulder surface located between the first sleeve portion and the second sleeve portion; a bearing sleeve fitted onto the second sleeve portion in a dimensional fit, allowing the bearing sleeve to move with the connecting sleeve and positioned between the connecting sleeve and the deformable membrane; the bearing sleeve having a first sleeve edge end adjacent to the shoulder surface and a second sleeve edge end opposite to the first sleeve edge end; and a bearing cover having: a mating portion forming a groove configured to engage with the second sleeve edge end, allowing the bearing cover to move with the bearing sleeve; and a mounting portion opposite to the mating portion and fixed to a first surface of the deformable membrane to transmit the applied force from the drive shaft to the deformable membrane.

8. The pressure generating device as described in claim 7, wherein, The deformable membrane forms a perforation, and the connecting unit further includes a fastener having: an enlarged head disposed on a second surface of the deformable membrane opposite to the first surface; and a fastening rod passing through the perforation of the deformable membrane from the enlarged head and terminating at a rod end, the rod end being fitted in a hole formed in the mounting portion of the bearing cap, so that the deformable membrane is fixed to the bearing cap by the fastener.

9. The pressure generating device as described in claim 8, wherein, The connecting unit further includes: a first washer disposed between the mounting portion and the first surface of the deformable membrane; and a second washer disposed between the enlarged head and the second surface of the deformable membrane.

10. The pressure generating device as claimed in claim 1 or 4 further includes a marker disposed at a second shaft end opposite to the first shaft end of the drive shaft so as to move with the drive shaft, and the marker having a plurality of detectable positions detectable by the photosensitive sensor for determining the displacement of the drive shaft.

11. The pressure generating device as described in claim 1 or 4, wherein, The deformable membrane has a hardness range between 0 Shore hardness and 100 Shore hardness; the thrust range of the drive device is between 100 grams and 1000 grams; and the stroke range of the drive device is between 3 millimeters and 50 millimeters.

12. A detection system for detecting the quality of a sample to be tested, comprising: a pressure generating device as described in claim 1; a micropipette for aspirating the sample to be tested; and a connecting tube configured to connect the communication port of the tank to the micropipette to apply the predetermined pressure to the sample to be tested.

13. The detection system as described in claim 12, wherein, The inner diameter of this micropipette ranges from 10 micrometers to 100 micrometers.

14. The detection system as described in claim 12 or 13, wherein, The pressure range of one suction port of this micropipette is 0.5 psi to -0.5 psi.

15. The detection system as described in claim 14, wherein, The connecting tube includes a first section that connects to the communication port of the tank and a second section that connects to the micro-pipette. The first section and the second section are connected by a regulating valve to regulate the pressure generated at the suction port of the micro-pipette.

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