Blockage detection method and detection device

Abstract

The present invention relates to a blockage detection method and a detection device, which are used to detect the internal blockage of medical consumables. The blockage detection method includes: adjusting the internal pressure of the liquid storage component to be not less than P2, where P2 is greater than the standard air pressure value; detecting whether the liquid storage component is depressurized, and in the case of pressure relief in the liquid storage component, determining that the liquid storage cavity of the liquid storage component is normally connected; adjusting the internal pressure of the liquid storage component to be greater than the standard air pressure value and not greater than P1, where P1 is less than P2; detecting whether the liquid storage component is depressurized, and in the case of no pressure relief in the liquid storage component, determining that the valve body can normally pre-close the liquid storage component. The detection device includes a blockage detection unit for detecting the internal pressure of the liquid storage component and presenting the detection result, and a pressurizing unit capable of connecting the liquid storage component so that the isobaric cavity of the pressurizing unit is pressure-equalized and connected with the liquid storage cavity of the liquid storage component, and for adjusting the internal pressure of the liquid storage component.

Description

Technical Field

[0001] The present invention relates to the technical field of medical consumables production, and in particular to a blockage detection method and a detection device. Background Art

[0002] The most common application scenario of medical consumables is to inject fluid substances into the human body, such as medicines, physiological regulation, diagnosis and treatment, or replenishment solutions. Therefore, the internal blockage of medical consumables is the key to determining whether the medical consumables can be used normally. Only when the internal cavity is connected normally will the supply of medicines or solutions not be interrupted. In addition, maintaining the sealed isolation of the liquid storage cavity of the medical consumables from the outside of the medical consumables when not in use is also important for maintaining the cleanliness of the internal medicines or solutions.

[0003] Taking the nasal drug delivery device as an example, the nasal drug delivery device includes a nebulizer and a syringe, which are connected as a whole for use, and a valve body is provided at the liquid supply port of the syringe. The existing detection method for nasal drug delivery devices, the test results obtained cannot be used as an accurate basis for judging whether the nasal drug delivery device can be used normally. For example, when the syringe is filled with fluid, if the test result is that there is no fluid overflow from the liquid outlet of the nebulizer, the possible reasons include 1) the syringe or the nebulizer is blocked internally; 2) the pre-pressure of the valve body on the syringe is too large, and the fluid is not enough to overcome the pre-pressure of the valve body. On the contrary, if the test result is that there is fluid overflow from the liquid outlet of the nebulizer, then although it can be considered that the internal cavity of the syringe and the nebulizer is unobstructed, it cannot be ruled out that the pre-pressure of the valve body is insufficient or the valve body has no pre-pressure. Insufficient or no pre-pressure of the valve body means that the liquid storage cavity of the syringe cannot be sealed and isolated from the outside, which will cause the fluid to leak out or be contaminated.

[0004] Therefore, there is an urgent need for a detection method or device that can accurately detect the blockage of the internal cavity of medical consumables, especially nasal drug delivery devices, and the sealing of the liquid storage cavity when not in use, and it is hoped that this method or device can be used to obtain true, accurate and reliable test results. Summary of the invention

[0005] In view of this, it is necessary to provide a blockage detection method for medical consumables, especially for nasal drug delivery devices, which can be used to quickly and accurately detect the blockage of the internal cavity of the medical consumables and the sealing of the liquid storage cavity when not in use, and obtain reliable test results.

[0006] Blockage detection methods include:

[0007] A. Adjust the internal pressure of the liquid storage assembly so that it is not less than P2, and P2 is greater than the standard air pressure value;

[0008] B. Detect whether the liquid storage component is depressurized, and if the liquid storage component is depressurized, determine whether the liquid storage cavity of the liquid storage component is normally connected;

[0009] C. Adjust the internal pressure of the liquid storage assembly to be greater than the standard air pressure value and not more than P1, where P1 is less than P2;

[0010] D. Check whether the liquid storage component is depressurized. If the liquid storage component is not depressurized, determine whether the valve body can pre-close the liquid storage component normally.

[0011] First, the internal pressure of the liquid storage component is increased to at least the level of P2. P2 is the preset upper limit of the pressure that needs to be loaded into the liquid storage component when the medical consumables discharge / inject fluid into the human body. That is, if the liquid cannot be discharged when the pressure in the liquid storage component reaches P2, it indicates that the patency of the internal cavity of the medical consumables under test is insufficient and does not meet the relevant product quality requirements, and needs to be repaired or scrapped; otherwise, the sealing test of the liquid storage cavity in the non-use state is continued, that is, to examine whether there is fluid escaping from the liquid storage cavity when the internal pressure of the liquid storage component is greater than the standard air pressure value but not exceeding P1. P1 is the upper limit of the liquid storage cavity pressure corresponding to the liquid supply port of the liquid storage component for maintaining the valve body pre-closed, and is also the preset lower limit of the pressure that needs to be loaded into the liquid storage component when the medical consumables discharge / inject fluid into the human body.

[0012] Therefore, the blockage detection method and detection device provided by the present invention have at least the following beneficial effects:

[0013] The cavity blockage detection of medical consumables and the sealing detection of the liquid storage cavity when not in use are carried out successively, which can significantly shorten the detection time and simplify the pressure regulation control of the liquid storage component, so as to achieve the required internal pressure regulation target of the liquid storage component faster and more accurately; based on the test results, a true and accurate conclusion can be obtained about whether the medical consumables can be used normally, avoiding the discharge of defective products due to insufficient testing or misjudgment of test results.

[0014] This allows the required pressure regulation target inside the reservoir to be achieved more quickly and accurately.

[0015] In one embodiment, the blockage detection method further includes:

[0016] E. Closing at least part of the chamber of the liquid discharge assembly to form a closed space connected to the liquid supply port of the liquid storage assembly;

[0017] F. Adjust the internal pressure of the liquid storage assembly so that it is not less than P1;

[0018] G. Check whether the liquid storage component is depressurized. If the liquid storage component is not depressurized, determine whether the sealing cooperation between the liquid storage component and the liquid discharge component is normal.

[0019] With such a configuration, medical consumables can be tested more comprehensively and fully. Theoretically, when the internal pressure of the liquid storage component exceeds P2 and pressure relief occurs, the communication path between the liquid storage chamber and the external environment of the medical consumables may be in the following three situations: 1) liquid storage chamber-liquid discharge chamber-liquid outlet; 2) liquid storage chamber-liquid storage component and liquid discharge component matching part; 3) liquid storage chamber-liquid discharge chamber-liquid outlet and liquid storage chamber-liquid storage component and liquid discharge component matching part. This embodiment can screen out unqualified products corresponding to situation 1) and situation 3), ensuring that the quality and reliability of the medical consumables products that are finally offline can meet the requirements, that is, not only can the fluid be discharged normally and the liquid storage component can be sealed by the valve body through pre-closure when not in use, but also the fluid will not leak from the matching part of the liquid storage component and the liquid discharge component when in use.

[0020] In one embodiment, step E, closing at least part of the chamber of the liquid discharge assembly to form a closed space connected to the liquid supply port of the liquid storage assembly, comprises:

[0021] E1. Use a sealing unit to seal the connection of the drainage assembly so that the side of the sealing unit facing away from the drainage cavity of the drainage assembly is sealed and separated from the drainage cavity by the sealing unit.

[0022] With such a configuration, the sealing unit closes the path of liquid storage chamber-liquid discharge chamber-liquid outlet which connects the liquid storage chamber with the external environment of the medical consumables. This ensures that when the liquid storage component and the liquid discharge component do not cooperate well, the fluid can only escape from the mating part of the liquid storage component and the liquid discharge component, thereby avoiding the inability to effectively detect the poor cooperation between the liquid storage component and the liquid discharge component.

[0023] In one embodiment, step G, detecting whether the liquid storage component is depressurized, and determining whether the sealing cooperation between the liquid storage component and the liquid discharge component is normal when the liquid storage component is not depressurized, includes:

[0024] G1. Maintain the internal pressure of the liquid storage component to be no less than P1, and the maintenance time is no less than the second preset maintenance time.

[0025] With such a configuration, by examining whether the liquid storage component is depressurized within the second preset maintenance time, a more reliable test result can be obtained, so that the actual sealing performance of the medical consumables product judged to be qualified is reliable, just as the sealing performance presented in its test results.

[0026] In one embodiment, the blockage detection method further includes:

[0027] H. Connect the pressurizing unit and the liquid storage assembly so that the isobaric cavity of the pressurizing unit is in pressure-equalizing communication with the liquid storage cavity of the liquid storage assembly;

[0028] The internal pressure of the liquid storage component is adjusted, including: the pressurizing unit absorbs the fluid or changes the amount of fluid sucked into the isobaric chamber to change the pressure of the liquid storage chamber.

[0029] With such arrangement, the pressure regulation method of the liquid storage chamber is simpler and easier to implement.

[0030] In one embodiment, detecting whether the liquid storage component is depressurized includes:

[0031] When the isobaric cavity is pressure-equalized and connected to the liquid storage cavity, the pressure value of the isobaric cavity is read by a pressure reading meter;

[0032] When the reading value of the pressure reading gauge does not decrease, it is determined that the liquid storage assembly is not depressurized;

[0033] When the reading value of the pressure reading gauge decreases, it is determined that the liquid storage assembly has been depressurized.

[0034] With such an arrangement, the determination of pressure relief of the liquid storage component is simpler and more intuitive, and the basis for the determination is more reliable.

[0035] In one embodiment, the blockage detection method further includes:

[0036] H. Connect the pressurizing unit and the liquid storage assembly so that the isobaric cavity of the pressurizing unit is in pressure-equalizing communication with the liquid storage cavity of the liquid storage assembly;

[0037] Step A, adjusting the internal pressure of the liquid storage component to be not less than P2, and P2 being greater than the standard air pressure value, comprises:

[0038] A1, the pressurizing unit absorbs the fluid into the isobaric chamber until the pressure of the isobaric chamber is greater than or equal to P2;

[0039] Step C, adjusting the internal pressure of the liquid storage assembly to be greater than the standard air pressure value and not exceeding P1, wherein P1 is less than P2, comprises:

[0040] C1, the pressurizing unit stops sucking fluid into the isobaric chamber 21, and the duration of the pressurizing unit stopping sucking fluid is not less than the first preset maintenance duration;

[0041] Step D, detecting whether the liquid storage component is depressurized, and determining that the valve body can normally close the liquid storage component when the liquid storage component is not depressurized, includes:

[0042] D1. Check whether the reading value of the pressure reading gauge decreases within the first preset maintenance time;

[0043] D2. When the reading value of the pressure reading gauge does not decrease within the first preset maintenance time, it is determined that the liquid storage component is not depressurized.

[0044] With such a configuration, the internal pressure of the liquid storage component can reach a level not exceeding P1 more quickly and accurately. When it is determined that the cavities of the liquid storage component and the liquid discharge component are unobstructed, the pressurizing unit is controlled to stop sucking in the fluid, and the remaining fluid in the liquid storage component spontaneously escapes to the outside of the medical consumables under the internal and external pressure difference. At the same time, the pressure in the liquid storage component gradually decreases, and the valve body also performs deformation recovery activities synchronously. Finally, when the internal pressure of the liquid storage component is reduced to a value not exceeding P1, the valve body automatically returns to the state of re-pre-closing the liquid storage component. Thereafter, the internal pressure of the liquid storage component can be ensured to be stable, and the determination of the sealing of the liquid storage cavity in the non-use state will not be interfered with by pressure fluctuations.

[0045] The present invention also provides a detection device, which uses the above-mentioned blocking detection method to detect the blocking condition of medical consumables, and the detection device includes:

[0046] A blockage detection unit, used to detect the internal pressure of the liquid storage component and present the detection result;

[0047] The pressurizing unit can be connected to the liquid storage assembly so that the isobaric cavity of the pressurizing unit is in pressure-equalizing communication with the liquid storage cavity of the liquid storage assembly, so as to adjust the internal pressure of the liquid storage assembly.

[0048] In one embodiment, the detection device further includes a first positioning component, and the first positioning component 30 includes:

[0049] A sealing unit, comprising a sealing mating portion adapted to the drain assembly;

[0050] The loading unit is connected to the sealing unit and can drive the sealing matching part to seal and match with the liquid discharge assembly by applying pressure to the sealing unit.

[0051] In this way, the sealing unit can close at least part of the chamber of the drainage component, thereby isolating the closed chamber of the drainage component from the external environment of the medical consumables, blocking the escape path of the fluid along the liquid storage chamber-liquid discharge chamber-liquid supply port, and thus providing confidence guarantee for accurately judging the sealing performance between the liquid storage component and the liquid discharge component.

[0052] In one embodiment, the sealing unit is provided with a clamping gap for the drainage assembly to be at least partially placed inside the sealing unit, and the periphery of the clamping gap forms a sealing fitting portion;

[0053] When the drainage component is at least partially placed inside the sealing unit and sealingly matched with the sealing matching portion, the sealing unit seals and separates the drainage cavity of the drainage component from the side of the sealing unit facing away from the clamping gap and the drainage component.

[0054] With such arrangement, the sealing fitting part can block the residual fluid in the drainage cavity from passing through and escaping, and the sealing unit clamps the drainage component so that all the drainage cavities of the drainage component are sealed and isolated by the sealing unit. During actual testing, the sealing connection between the sealing unit and the drainage component is more convenient, easy to operate and has a better sealing effect, and the position stability of the sealing fitting part after it is attached to the drainage component is stronger.

[0055] In one embodiment, the sealing unit is annular or tubular and has deformation freedom. The clamping gap is opened at the first end of the sealing unit. The loading unit is connected to the second end of the sealing unit opposite to the first end. The loading unit can apply pressure to the second end directed to the first end.

[0056] In this way, under the external force of the loading unit, the sealing unit can produce a deformation that reduces the clamping gap, thereby reducing the gap width or aperture size of its sealing matching part, so that a pressure distributed along the circumference and acting on the axis of the drainage component can be applied to the drainage component. This embodiment significantly simplifies the connection method and force action method between the loading unit and the sealing unit.

[0057] In one embodiment, the first positioning assembly further includes a stop-swelling unit adapted to the outer shape of the sealing unit, and the first end and the outer periphery of the sealing unit are in contact with the stop-swelling unit; and / or,

[0058] The first positioning assembly also includes a guide unit, which is in a tubular shape and sleeves a sealing unit and a loading unit. The sealing unit is fixedly connected to the guide unit, and the loading unit is slidably matched with the inner side wall of the guide unit.

[0059] With such a configuration, the anti-expansion unit can limit the increase in the radial and axial dimensions of the outer side of the sealing unit, forcing the sealing unit to expand and deform inward to reduce the size of the clamping gap, thereby reducing the gap width or aperture size of its sealing mating part; at the same time, the force applied to the drainage component is reasonable, and it is not easy to cause its radial cross-section to become elliptical or elongated.

[0060] In one embodiment, the pressurizing unit has an isobaric chamber, and can connect the isobaric chamber to the liquid storage chamber of the liquid storage assembly by connecting the liquid storage assembly so that the isobaric chamber is pressure-equalized and connected; the blockage detection unit includes a pressure reading meter, which is used to read the pressure of the isobaric chamber when the isobaric chamber is pressure-equalized and connected to the liquid storage chamber.

[0061] With this arrangement, it is more convenient to read the internal pressure of the liquid storage component. Setting the pressure reader in the isobaric chamber will not affect the measurement result of the internal pressure value of the liquid storage component. By directly reading the pressure value, it is possible to determine whether the internal pressure of the liquid storage component is stable or relieved. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1This is a schematic diagram of a detection device in a first state after being adapted and connected to a medical consumable according to an embodiment of the present invention;

[0063] Figure 2 This is a schematic diagram of a detection device in a second state after being adapted and connected to a medical consumable according to an embodiment of the present invention;

[0064] Figure 3 It is a schematic structural diagram of a first positioning component of a detection device according to an embodiment of the present invention.

[0065] Description of reference numerals:

[0066] 100, detection device; 11, pressure reading meter; 20, pressurizing unit; 21, isobaric chamber; 30, first positioning assembly; 31, sealing unit; 311, clamping gap; 32, loading unit; 33, guiding unit; 35, anti-expansion unit; 40, pressure relief detection unit;

[0067] 200. Medical consumables; 210. Liquid storage component; 2101. Liquid inlet; 2102. Liquid supply port; 2103. Liquid storage chamber; 220. Liquid discharge component; 2201. Liquid injection port; 2202. Liquid outlet; 2203. Liquid discharge chamber; 2204. Accommodating space; 230. Valve body. DETAILED DESCRIPTION

[0068] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0069] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "or / and" used herein includes any and all combinations of one or more related listed items.

[0070] The present invention provides a method and device 100 for detecting blockage of medical consumables 200, especially a combined injection device for injecting fluid into the human body, such as a nasal drug delivery device, which mainly detects the blockage of the internal cavity of the medical consumables 200 and the sealing performance in a non-use state. The fluid contained in the medical consumables 200 can be a medicine, a physiological regulation or replenishment solution, which is not particularly limited in the present invention; in addition, the present invention is not limited to the detection of nasal drug delivery devices.

[0071] Taking the nasal drug delivery device as an example, the nasal drug delivery device includes a liquid storage component 210, a liquid discharge component 220 and a valve body 230. The liquid storage component 210 is in the shape of a tube and is used to contain liquid medicine; the liquid discharge component 220 is in the shape of a cone, and has a receiving space 2204 for the liquid storage component 210 to extend and be placed therein, and a liquid discharge cavity 2203 connected to the receiving space 2204; the valve body 230 is movably arranged in the receiving space 2204 and has a certain elastic deformation ability.

[0072] The liquid storage component 210 extends from one end of the base of the liquid discharge component 220 and is sealed with the inner wall surface used to enclose the accommodating space 2204. The matching parts of the two are as shown in FIG. Figure 1 to Figure 2 The liquid storage component 210 is provided with a liquid storage cavity 2103 which runs through both ends thereof and is used to contain medicine. The liquid storage cavity 2103 forms a liquid inlet 2101 at one end of the liquid storage component 210 away from the liquid discharge component 220, and forms a liquid supply port 2102 at one end of the liquid storage component 210 extending into the accommodating space 2204. The valve body 230 is arranged opposite to the liquid supply port 2102.

[0073] The inner diameter of the accommodating space 2204 is larger than the inner diameter of the drainage cavity 2203, so a step surface is provided inside the drainage component 220, and the opening of the drainage cavity 2203 formed on the step surface is the injection port 2201, and the opening of the drainage cavity 2203 formed on the other end of the drainage component 220 relatively far from its base is the liquid outlet 2202, from which the medicine is discharged from the nasal drug delivery device, and a pressure relief detection unit 40 is provided outside the liquid outlet 2202 for sensing whether there is fluid flowing out of the liquid outlet 2202, so that it can detect whether the liquid storage component 210 is depressurized. In the non-use state, that is, the pressure in the liquid storage cavity 2103 is the same as or close to the standard atmospheric pressure, the valve body 230 generates pre-pressure on one end of the liquid storage component 210 forming the liquid supply port 2102, so the valve body 230 pre-closes the liquid storage cavity 2103. If the existence of the valve body 230 is not considered, the liquid storage chamber 2103, the accommodating space 2204 and the liquid discharge chamber 2203 are connected.

[0074] As mentioned above, the valve body 230 has elastic deformation capability, and when the pressure of the liquid storage chamber 2103 increases, the valve body 230 undergoes compressive elastic deformation under the action of pressure. The pressure of the liquid storage chamber 2103 is continuously increased until the valve body 230 is compressed to a size capable of opening the liquid supply port 2102, at which time the nasal drug delivery device is switched to the use state, and the liquid storage chamber 2103 and the accommodating space 2204 are connected, and in this embodiment, due to the specific structural design of the valve body 230 (the structural design of the valve body 230 is not related to the technical problem of the present invention, so the specific structure of the valve body 230 is not described in detail here), the accommodating space 2204 and the liquid discharge chamber 2203 are always connected, so after switching to the use state, the liquid storage chamber 2103, the accommodating space 2204 and the liquid discharge chamber 2203 are all connected.

[0075] The following introduces the specific steps of the blockage detection method, which includes:

[0076] S10, adjusting the internal pressure of the liquid storage assembly 210 to be not less than P2, and P2 is greater than the standard air pressure value;

[0077] S20, detecting whether the liquid storage component 210 is depressurized, and in the case that the liquid storage component 210 is depressurized, determining that the liquid storage chamber 2103 of the liquid storage component 210 is normally connected;

[0078] S30, adjusting the internal pressure of the liquid storage assembly 210 to be greater than the standard air pressure value and not exceeding P1, wherein P1 is less than P2;

[0079] S40, detecting whether the liquid storage component 210 is depressurized, and if the liquid storage component 210 is not depressurized, determining that the valve body 230 can pre-close the liquid storage component 210 normally;

[0080] S50, closing at least part of the chamber of the liquid discharge assembly 220 to form a closed space connected to the liquid supply port 2102 of the liquid storage assembly 210;

[0081] S60, adjusting the internal pressure of the liquid storage assembly 210 to be no less than P1;

[0082] S70, detecting whether the liquid storage assembly 210 is depressurized. When the liquid storage assembly 210 is not depressurized, determining whether the sealing cooperation between the liquid storage assembly 210 and the liquid discharge assembly 220 is normal.

[0083] Here, P2>P1 is greater than the standard air pressure value, wherein P2 is a preset upper pressure limit value, which is the maximum pressure that can be allowed inside the liquid storage component 210 when the liquid is discharged from the liquid discharge component 220, that is, if the pressure in the liquid storage cavity 2103 reaches P2 and liquid is still unable to be supplied to the liquid discharge cavity 2203, then the internal cavity of the nasal drug delivery device is determined to be blocked, and such a nasal drug delivery device cannot be used normally; P1 is a preset critical pressure value, if the internal pressure of the liquid storage component 210 reaches P1 and the liquid storage component 210 does not release pressure, then it can be confirmed with certainty that the valve body 230 can normally apply pre-pressure to the liquid supply port 2102, thereby normally pre-closing the liquid storage cavity 2103 when not in use; and when the internal pressure of the liquid storage component 210 is greater than P1, it is acceptable for the liquid storage component 210 to release pressure.

[0084] After executing step S10, if it is detected that the liquid storage component 210 has not released pressure, then it can be determined that the patency of the internal cavity of the nasal drug delivery device is insufficient. It may be that a blockage occurs inside the liquid storage component 210 or inside the discharge component 220. The cause of the blockage may be that the adhesive accidentally flows into the accommodating space 2204 or the discharge cavity 2203 when the liquid storage component 210 and the discharge component 220 are bonded and cured at the previous workstation, thereby blocking the injection port 2201 or the discharge cavity 2203.

[0085] It should be noted that if the pressure relief of the liquid storage component 210 is detected after executing step S10, it can only be determined that the liquid storage chamber 2103 is normally connected, and it cannot be inferred that the liquid discharge chamber 2203 is normally connected. This is because the fluid in the liquid storage chamber 2103 and the accommodating space 2204 may not escape from the liquid discharge chamber 2203, but from the matching part of the liquid storage component 210 and the liquid discharge component 220. Therefore, for the latter possible situation, it is necessary to execute steps S50, S60 and S70 to confirm it.

[0086] The purpose of setting step S50 is: before testing the air tightness of the matching part of the liquid storage component 210 and the liquid discharge component 220, first close the flow path of the fluid escaping from the internal chamber of the liquid discharge component 220 to the outside of the liquid discharge component 220, and the closed position can be the inner wall surface of the liquid discharge cavity 2203, or the end surface of the liquid discharge component 220 used to form the liquid outlet 2202, or the outer end surface of the liquid discharge component 220. Therefore, after closing, the closed space connected with the liquid storage cavity 2103 / liquid supply port 2102 can be either the accommodating space 2204+part of the liquid discharge cavity 2203, or the accommodating space 2204+all of the liquid discharge cavity 2203. Next, step S60 is executed. If it is detected that the liquid storage component 210 has released pressure, it can be concluded with certainty that the sealing cooperation between the liquid storage component 210 and the liquid discharge component 220 is poor, because at this time, the flow path allowing the gas in the liquid storage chamber 2103 to escape can only be the cooperation part between the liquid storage component 210 and the liquid discharge component 220.

[0087] Specifically, step S50 includes:

[0088] S51, using the sealing unit 31 to seal the drain assembly 220, so that the side of the sealing unit 31 facing away from the drain cavity 2203 of the drain assembly 220 is sealed and separated from the drain cavity 2203 by the sealing unit 31;

[0089] Step S60 includes:

[0090] S61, adjusting the internal pressure of the liquid storage assembly 210 to be not less than P3, wherein P3 is greater than P2;

[0091] As mentioned above, P2 is a preset theoretical upper limit of pressure. For different nasal drug delivery devices, the internal pressure of the liquid storage component 210 required when the valve body 230 opens the liquid supply port 2102 is not the same, which is mainly affected by factors such as the size or material type of the valve body 230. Regardless of the form of medical consumables 200, if it is to meet the qualified requirements, especially the patency requirements, the liquid storage chamber 2103 must be able to release pressure when the internal pressure of the liquid storage component 210 reaches P2. In order to ensure that various forms of medical consumables 200 are correctly and rigorously tested, and to prevent some medical consumables 200 that were originally designed to require a large external force to release pressure but have a gap between the liquid storage component 210 and the liquid discharge component 220 from being misjudged as qualified products with good airtightness, the internal pressure adjustment target of the liquid storage component 210 is increased to P3 for step S60. In other words, there is a possibility that when executing step S60, although the internal pressure of the liquid storage component 210 is greater than P1, it is not enough to overcome the pre-pressure of the valve body 230 on the liquid supply port 2102, and is not enough to cause the liquid storage chamber 2103 to release pressure. At this time, if the medical consumables 200 in which the liquid storage component 210 has not released pressure is judged to have good sealing, it is possible that products with poor sealing will be missed from inspection and offline.

[0092] As a preferred implementation, step S30 and step S40 are performed after step S10 and step S20 are performed; and before step S10 is performed, the blockage detection method further includes:

[0093] S01, connecting the pressurizing unit 20 and the liquid storage assembly 210, so that the isobaric chamber 21 of the pressurizing unit 20 and the liquid storage chamber 2103 of the liquid storage assembly 210 are in pressure-equalizing communication;

[0094] After the pressurizing unit 20 and the liquid storage component 210 are connected, the two form a sealed fit, so that the isobaric chamber 21 is connected to the liquid storage chamber 2103. If the pressure of the isobaric chamber 21 changes, the liquid storage chamber 2103 will change accordingly until the pressures of the two reach the same level. Therefore, it can be considered that the isobaric chamber 21 and the liquid storage chamber 2103 can share an equal pressure value, and the isobaric chamber 21 is subjected to pressure detection, and the detection result can replace the pressure value of the liquid storage chamber 2103.

[0095] The adjustment of the internal pressure of the liquid storage assembly 210 involved in the aforementioned steps S10, S30 and S60 is achieved by the following means:

[0096] The pressurizing unit 20 inhales fluid or changes the amount of fluid inhaled into its isobaric chamber 21 to change the pressure of the liquid storage chamber 2103. Preferably, the pressurizing unit 20 changes the pressure of the isobaric chamber 21 and the liquid storage chamber 2103 by inhaling gas or changing the amount of gas inhaled into the isobaric chamber 21.

[0097] The internal pressure of the liquid storage assembly 210 involved in the aforementioned steps S20, S40, and S70 is detected by the following means:

[0098] When the isobaric chamber 21 and the liquid storage chamber 2103 are kept in pressure-equalizing communication, that is, the pressurizing unit 20 and the liquid storage assembly 210 are kept in sealed connection, the pressure value of the isobaric chamber 21 is read by the pressure reading meter 11;

[0099] When the reading value of the pressure reading gauge 11 does not decrease, it is determined that the liquid storage assembly 210 is not depressurized;

[0100] When the reading value of the pressure reading gauge 11 decreases, it is determined that the liquid storage assembly 210 is depressurized.

[0101] The liquid storage component 210 itself has a precise structure and a small size. It is extremely difficult and costly to directly measure the pressure of its liquid storage chamber 2103, whether selecting a test reading device or setting the test reading device in the liquid storage chamber 2103. However, because the isobaric chamber 21 and the liquid storage chamber 2103 can be connected at equal pressure, the pressure of the liquid storage chamber 2103 can be indirectly obtained by directly measuring the pressure of the isobaric chamber 21, and the selection and arrangement of the pressure reading meter 11 are easier.

[0102] Based on the above, step S10 includes:

[0103] S11, the pressurizing unit 20 absorbs the fluid into the isobaric chamber 21 until the pressure of the isobaric chamber 21 is greater than or equal to P2;

[0104] Step S20 includes:

[0105] S21, checking whether the reading value of the pressure reading gauge 11 decreases;

[0106] S22, when the reading value of the pressure reading meter 11 decreases, it is determined that the liquid storage chamber 2103 of the liquid storage assembly 210 is normally connected; otherwise, it is determined that the liquid storage chamber 2103 of the liquid storage assembly 210 is not patency-adequate;

[0107] Step S30 includes:

[0108] S31, the pressurizing unit 20 stops sucking the fluid into the isobaric chamber 21, and the duration of the pressurizing unit 20 stopping sucking the fluid is not less than the first preset maintenance duration;

[0109] Step S40 includes:

[0110] S41, examining whether the reading value of the pressure reading meter 11 decreases within the first preset maintenance time;

[0111] S42, when the reading value of the pressure reading meter 11 does not decrease within the first preset maintenance time, it is determined that the liquid storage component 210 can pre-close the liquid storage component 210 normally; otherwise, it is determined that the liquid storage component 210 cannot pre-close the liquid storage chamber 2103;

[0112] Step S50 includes:

[0113] S51, using the sealing unit 31 to seal the drain assembly 220, so that the side of the sealing unit 31 facing away from the drain cavity 2203 of the drain assembly 220 is sealed and separated from the drain cavity 2203 by the sealing unit 31;

[0114] Step S60 includes:

[0115] S61, adjusting the internal pressure of the liquid storage assembly 210 to be not less than P3, wherein P3 is greater than P2;

[0116] Step S70 includes:

[0117] S71, examining whether the reading value of the pressure reading meter 11 decreases within the second preset maintenance time;

[0118] S72. When the internal pressure of the liquid storage component 210 does not decrease within the second preset maintenance time, it is determined that the sealing cooperation between the liquid storage component 210 and the liquid discharge component 220 is normal; otherwise, it is determined that the sealing cooperation between the liquid storage component 210 and the liquid discharge component 220 is poor.

[0119] It should be emphasized that after executing step S10, since the pressure of the liquid storage chamber 2103 is higher than the standard air pressure value before exceeding P2, that is, the liquid storage chamber 2103 is already in a high-pressure environment before its pressure exceeds P2, and the pressure at each position in the liquid storage chamber 2103 is basically equal. Therefore, once the pressure of the liquid storage chamber 2103 is released, the fluid storage volume in the liquid storage chamber 2103 is reduced, and under the action of fluid fluidity and fluid pressure potential energy, the pressure difference at each position in the liquid storage chamber 2103 will be eliminated at a very fast rate. In other words, the fluid in the local high-pressure area / area relatively far from the liquid supply port 2102 in the liquid storage chamber 2103 will quickly flow to the area where the fluid escapes / area relatively close to the liquid supply port 2102, until the valve body 230 closes the liquid supply port 2102, and finally the liquid storage chamber 2103 will be switched back to a state of equal pressure everywhere in a very short time.

[0120] Therefore, after executing step S31, if the valve body 230 of the medical consumable 200 being tested can indeed meet the requirements of the pre-closing function, then its valve body 230 will reclose the liquid supply port 2102 in a very short time, which means that the pressure of the liquid storage chamber 2103 will be restored to a stable state at a very fast rate, and the pressure difference at each position in the liquid storage chamber 2103 will be eliminated in a very short time to achieve a state of equal pressure everywhere. Therefore, in the first preset maintenance time immediately following, the reading value of the pressure reading meter 11 will hardly change, but stabilize at a level greater than the standard atmospheric pressure value. This is consistent with the situation where the reading value of the pressure reading meter 11 does not decrease within the first preset maintenance time.

[0121] In this embodiment, the first preset holding time is 10 to 20 seconds, and the second preset holding time is 5 to 10 seconds.

[0122] The following describes a detection device 100, which can detect medical consumables 200 using the above blockage detection method, and includes a blockage detection unit and a pressurizing unit 20; the blockage detection unit is used to detect the internal pressure of the liquid storage component 210 and immediately present the detection result, and the pressurizing unit 20 can be sealed and connected with the liquid storage component 210 in advance before the formal detection operation, so that the isobaric chamber 21 of the pressurizing unit 20 and the liquid storage chamber 2103 of the liquid storage component 210 are connected at equal pressure, and then the pressurizing unit 20 changes the pressure in the isobaric chamber 21 by switching the operating state, thereby adjusting the pressure of the liquid storage chamber 2103. In this embodiment, the blockage detection unit includes a pressure reading meter 11 at least partially disposed in the isobaric chamber 21, and once the pressurizing unit 20 and the liquid storage component 210 are sealed, the pressure reading meter 11 can read and present the pressure value of the isobaric chamber 21.

[0123] Furthermore, the detection device 100 also includes a first positioning component 30, and the purpose of the first positioning component 30 is to assist in the execution of step S50, that is, before executing steps S60 and S70, at least part of the chamber of the drainage component 220 is closed first to form a closed space connected to the liquid supply port 2102 of the liquid storage component 210, and this closed space is airtightly separated from the external environment of the medical consumables 200.

[0124] See also Figure 3 The first positioning assembly 30 includes a sealing unit 31, a loading unit 32, an anti-swelling unit 35 and a guide unit 33. The sealing unit 31 is annular or tubular and has elastic deformation capability. The first end of the sealing unit 31 forms a clamping gap 311 by opening a sink, a cavity or a blind hole. The opening edge of the sink, the cavity or the blind hole forms a sealing fitting portion. The shape of the sealing fitting portion is adapted to the outer wall of the drainage assembly 220. The clamping gap 311 allows one end of the drainage assembly 220 formed with the liquid outlet 2202 to extend into the sealing unit 31, so that at least part of the structure of the drainage assembly 220 is accommodated in the sealing unit 31, and the sealing unit 31 thus surrounds and fits the outer wall of the drainage assembly 220.

[0125] The loading unit 32 is arranged outside the second end of the sealing unit 31, and the second end of the sealing unit 31 is arranged opposite to the first end thereof. The loading unit 32 can exert pressure directed to the first end of the sealing unit 31 on the second end to force the sealing unit 31 to undergo elastic deformation. As the pressure exerted by the loading unit 32 on the second end gradually increases, the inner diameter of the clamping gap 311 gradually decreases, and the sealing fitting part and the outer wall of the drainage component 220 gradually come into close contact to form a sealing fit. Finally, all the drainage cavities 2203 of the drainage component 220 are closed by the sealing unit 31, and the side of the sealing unit 31 facing away from the clamping gap 311 and the drainage component 220, that is, the axial direction of the sealing unit 31 and the outer side of the second end are sealed and separated from the drainage cavity 2203. If the loading unit 32 cancels the pressure on the second end, the opening of the clamping gap 311 will gradually increase until the sealing fit between the sealing unit 31 and the drainage component 220 is canceled.

[0126] The reason why the pressure applied by the loading unit 32 to the second end can reduce the opening of the clamping gap 311 is that the anti-expansion unit 35 is conformally adapted to at least part of the outer surface shape of the sealing unit 31. In this embodiment, the anti-expansion unit 35 is sleeved on the first end of the sealing unit 31, including a bottom shell and an embracing portion protruding from one end of the bottom shell and extending axially along the bottom shell. The bottom shell is provided with a through hole so that when the sealing unit 31 is adapted and connected thereto, the clamping gap 311 corresponds coaxially to the through hole. After the sealing unit 31 is conformally adapted to the anti-expansion unit 35, the first end fits against the bottom wall of the bottom shell, and the outer peripheral wall fits against the inner wall of the embracing portion. Therefore, the anti-expansion unit 35 can limit the elastic deformation freedom of the sealing unit 31 to radially expand the outer peripheral wall size and expand the axial size. When the loading unit 32 applies pressure to the second end, the radial outward expansion and deformation of the outer wall of the sealing unit 31 toward the outside of the first end are restricted, forcing the inner wall of the clamping gap 311 to expand toward its axis, thereby reducing the inner diameter of the clamping gap 311 and the size of the sealing fitting portion.

[0127] The guide unit 33 is in the shape of a straight tube, and the loading unit 32 includes a push rod and a force-applying part connected to the end of the push rod. The force-applying part is slidably matched with the inner peripheral wall of the guide unit 33. At the same time, the guide unit 33, the sealing unit 31 and the anti-swelling unit 35 are all coaxially arranged. The force-applying direction of the loading unit 32, that is, the direction in which the force-applying part slides inside the guide unit 33, is consistent with the axial direction of the drainage component 220 / sealing unit 31 / anti-swelling unit 35. The setting of the guide unit 33 enables the loading unit 32 to uniformly apply pressure to the second end of the sealing unit 31, ensuring that the pressure on the surface of the second end is basically equal, which is conducive to the uniform inward contraction of the clamping gap 311, and drives the sealing matching part and the drainage component 220 to form a sealing match with uniform pressure along the circumferential direction, so as to improve the reliability of the sealing connection between the two.

[0128] Preferably, in this embodiment, the guide unit 33 is sleeved on a portion of the outer peripheral wall of the sealing unit 31 , and the guide unit 33 and the anti-swelling unit 35 are fixedly connected as a whole.

[0129] It should be noted that the above embodiment of the first positioning component 30 is only a preferred scheme. In other embodiments, the part where the sealing unit 31 and the drainage component 220 form a sealing fit is not necessarily on the outer peripheral wall of the drainage component 220. For example, the sealing unit 31 can extend into the drainage cavity 2203 and seal with the inner wall surface of the drainage cavity 2203. After the sealing fit, the drainage cavity 2203 part of the sealing unit 31 on the side facing away from the liquid outlet 2202 of the drainage component 220 forms a closed space and is airtightly separated from the external environment of the drainage component 220; in addition, in other embodiments, the loading unit 32 does not necessarily apply axial pressure to the second end of the sealing unit 31, but can also apply radial pressure to the outer peripheral wall of the sealing unit 31, and the pressure direction is consistent with the contraction direction of the sealing fit; the anti-swelling unit 35 and the guide unit 33 can also be adaptively changed or cancelled according to the structure of the sealing unit 31 and the loading unit 32 and the force application method of the loading unit 32.

[0130] In one embodiment, the detection device 100 further includes a leak detection unit, which is used to sense the fluid discharged through the matching portion of the liquid discharge component 220 and the liquid storage component 210. Optionally, there are multiple leak detection units, and the multiple leak detection units are arranged along the opening edge of the accommodating space 2204 of the liquid discharge component 220; or, the leak detection unit extends along the opening edge of the accommodating space 2204.

[0131] With such an arrangement, the detection result of the leak detection unit can be used as a basis for judging whether the liquid discharge component 220 and the liquid storage component 210 are well sealed and matched, with higher certainty, and avoids the situation where the fluid is only partially discharged from the opening of the accommodating space 2204 without being detected by the leak detection unit due to too few leak detection units or unreasonable arrangement.

[0132] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0133] Those skilled in the art should recognize that the above embodiments are only used to illustrate the present invention, and are not intended to limit the present invention. As long as they are within the spirit of the present invention, appropriate changes and modifications to the above embodiments are within the scope of protection claimed by the present invention.

Claims

1. A blockage detection method for detecting blockage inside a medical consumable (200), the medical consumable comprising a liquid storage component (210) having a liquid storage cavity (2103), a liquid discharge component (220) having a accommodating space (2204) and a liquid discharge cavity (2203) that are connected, and a valve body (230) disposed in the accommodating space (2204) and having elastic deformation capability, the liquid storage component (210) extending into the accommodating space (2204) and sealingly cooperating with an inner wall of the accommodating space (2204), and the liquid storage cavity (2103) forming a liquid supply port (2102) disposed opposite to the valve body (230) at one end of the liquid storage component (210) extending into the accommodating space (2204); It is characterized in that The blocking detection method comprises: A. adjusting the internal pressure of the liquid storage component (210) to not less than P2, where P2 is greater than the standard air pressure value, and P2 is the maximum pressure allowed inside the liquid storage component (210) when the liquid is discharged from the liquid discharge component (220); B. Detecting whether the liquid storage component (210) is depressurized, and in the case where the liquid storage component (210) is depressurized, determining whether the liquid storage chamber (2103) of the liquid storage component (210) is normally connected; C. Adjusting the internal pressure of the liquid storage component (210) to a value greater than the standard air pressure value and not exceeding P1, wherein P1 is less than P2, and P1 is a preset critical pressure value. P1 is both the upper limit of the pressure of the liquid storage chamber (2103) when the valve body (230) pre-closes the liquid supply port (2102), and the lower limit of the internal pressure of the liquid storage component (210) when the medical consumable discharges liquid. When the internal pressure of the liquid storage component (210) reaches P1 and the liquid storage component (210) does not release pressure, the valve body (230) pre-closes the liquid storage chamber (2103) normally. When the internal pressure of the liquid storage component (210) is greater than P1, pressure release of the liquid storage component (210) is acceptable. D. Detecting whether the liquid storage component (210) is depressurized, and in the case that the liquid storage component (210) is not depressurized, determining that the valve body (230) is capable of pre-closing the liquid storage component (210) normally.

2. The blockage detection method according to claim 1, characterized in that: The blocking detection method further comprises: E. Closing at least part of the chamber of the liquid discharge assembly (220) to form a closed space connected to the liquid supply port (2102) of the liquid storage assembly (210); F. adjusting the internal pressure of the liquid storage assembly (210) to be no less than P1; G. Detect whether the liquid storage component (210) is depressurized. If the liquid storage component (210) is not depressurized, determine whether the sealing cooperation between the liquid storage component (210) and the liquid discharge component (220) is normal.

3. The blockage detection method according to claim 2, characterized in that: Step E, closing at least part of the chamber of the liquid discharge assembly (220) to form a closed space connected to the liquid supply port (2102) of the liquid storage assembly (210), comprising: E1. Use the sealing unit (31) to seal the drain assembly (220), so that the side of the sealing unit (31) facing away from the drain cavity (2203) of the drain assembly (220) is sealed and separated from the drain cavity (2203) by the sealing unit (31).

4. The blockage detection method according to claim 1 or 2, characterized in that: The blocking detection method further comprises: H. connecting the pressurizing unit (20) and the liquid storage assembly (210) so that the isobaric chamber (21) of the pressurizing unit (20) and the liquid storage chamber (2103) of the liquid storage assembly (210) are in pressure-equalizing communication; The internal pressure of the liquid storage component (210) is adjusted, including: the pressurizing unit (20) absorbs the fluid or changes the amount of fluid sucked into the isobaric chamber (21) to change the pressure of the liquid storage chamber (2103).

5. The blockage detection method according to claim 4, characterized in that: Detecting whether the liquid storage component (210) is depressurized includes: When the isobaric chamber (21) is pressure-equalized and connected to the liquid storage chamber (2103), a pressure reading meter is used to read the pressure value of the isobaric chamber (21); When the reading value of the pressure reading gauge (11) does not decrease, it is determined that the liquid storage component (210) is not depressurized; When the reading value of the pressure reading gauge (11) decreases, it is determined that the liquid storage assembly (210) is depressurized.

6. The blockage detection method according to claim 1 or 5, characterized in that: The blocking detection method further comprises: H. connecting the pressurizing unit (20) and the liquid storage assembly (210) so that the isobaric chamber (21) of the pressurizing unit (20) and the liquid storage chamber (2103) of the liquid storage assembly (210) are in pressure-equalizing communication; Step A, adjusting the internal pressure of the liquid storage component (210) to be not less than P2, and P2 being greater than the standard air pressure value, comprises: A1, the pressurizing unit (20) absorbs the fluid into the isobaric chamber (21) until the pressure of the isobaric chamber (21) is greater than or equal to P2; Step C, adjusting the internal pressure of the liquid storage component (210) to be greater than the standard air pressure value and not exceeding P1, wherein P1 is less than P2, comprises: C1. The pressurizing unit (20) stops sucking fluid into the isobaric chamber (21), and the duration of the pressurizing unit (20) stopping sucking fluid is not less than a first preset maintenance duration.

7. A detection device, characterized in that: The detection device detects the blockage condition of the medical consumable (200) using the blockage detection method according to any one of claims 1 to 6, and the detection device comprises: A blockage detection unit, used to detect the internal pressure of the liquid storage component (210) and present the detection result; The pressurizing unit (20) can be connected to the liquid storage component (210) so that the isobaric chamber (21) of the pressurizing unit (20) and the liquid storage chamber (2103) of the liquid storage component (210) are in pressure-equalizing communication, and is used to adjust the internal pressure of the liquid storage component (210).

8. The detection device according to claim 7, characterized in that: The detection device further comprises a first positioning component (30), wherein the first positioning component (30) comprises: A sealing unit (31), comprising a sealing matching portion adapted to match the liquid discharge assembly (220); The loading unit (32) is connected to the sealing unit (31) and can drive the sealing fitting portion to seal and fit with the liquid discharge assembly (220) by applying pressure to the sealing unit (31).

9. The detection device according to claim 8, characterized in that: The sealing unit (31) is provided with a clamping gap (311) for the drainage assembly (220) to be at least partially placed inside the sealing unit (31), and the periphery of the clamping gap (311) forms the sealing matching portion; When the drainage component (220) is at least partially placed inside the sealing unit (31) and is sealed with the sealing mating portion, the sealing unit (31) hermetically separates the side of the sealing unit (31) facing away from the clamping gap (311) and the drainage component (220) from the drainage cavity (2203) of the drainage component (220).

10. The detection device according to claim 9, characterized in that: The sealing unit (31) is annular or tubular and has a degree of freedom of deformation. The clamping gap (311) is opened at a first end of the sealing unit (31). The loading unit (32) is connected to a second end of the sealing unit (31) arranged opposite to the first end. The loading unit (32) can apply pressure directed toward the first end to the second end.

11. The detection device according to claim 10, characterized in that: The first positioning assembly (30) further comprises an anti-swelling unit (35) adapted to the external shape of the sealing unit (31), and the first end and the outer periphery of the sealing unit (31) are in contact with the anti-swelling unit (35); and / or, The first positioning assembly (30) further comprises a guide unit (33), the guide unit (33) being in the shape of a tube and sleeved with the sealing unit (31) and the loading unit (32), the sealing unit (31) being fixedly connected to the guide unit (33), and the loading unit (32) being slidably matched with the inner side wall of the guide unit (33).

12. The detection device according to claim 7, characterized in that: The pressurizing unit (20) has an isobaric chamber (21), and can be connected to a liquid storage component (210) so that the isobaric chamber (21) is connected to a liquid storage chamber (2103) of the liquid storage component (210) at an equalized pressure; the blockage detection unit comprises a pressure reading meter (11), and the pressure reading meter (11) is used to read the pressure of the isobaric chamber (21) when the isobaric chamber (21) is connected to the liquid storage chamber (2103) at an equalized pressure.

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