CN116942951A - Flow limiting structure of medical device - Google Patents

Abstract

The present disclosure provides a flow restriction structure of a medical device, including a flow rate supplier, a first passage connected to the flow rate supplier, a second passage connected to the flow rate supplier, and a flow restriction valve having a first through hole and a second through hole, the flow restriction valve changing an axial direction of the first through hole and the second through hole by rotating a predetermined angle and switching between a first state and a second state, the first through hole communicating the first passage and the flow rate supplier and the second through hole not communicating with the second passage when the flow restriction valve is in the first state; when the restrictor valve is in the second state, the second through hole communicates with the second passage and the flow supplier, and the first through hole does not communicate with the first passage. The medical device can be used for fluid delivery, and when carrying out fluid delivery, the restriction structure can carry out quantitative control to fluid delivery, and in addition, the restriction structure has simple reliable safe restraint structure, can be convenient for simplify medical device in order to promote the space occupation ratio of fluid storage and reduce manufacturing cost.

Description

Flow limiting structure of medical device

Technical Field

The present disclosure relates generally to the field of medical devices, and more particularly to a flow restricting structure for a medical device.

Background

For many chronic diseases, corresponding complications are often incurred, for example, chronic diabetes may incur complications associated with blood glucose. In order to delay and reduce the rapid or persistent effects on patients caused by chronic diseases, automatic drug injection administration techniques may be employed on patients. In the existing drug delivery technology, the portable drug delivery system is widely applied, a pipeline is usually implanted under the skin, and when the abnormality of the physiological characteristics of a patient reaches the early warning, the patient can input the dosage of the injected drug through a controller and insert a drug pump filled with the drug liquid into the previously reserved pipeline for drug delivery.

In the prior art, the publication CN106267464a discloses a hydraulic transmission for a fluid infusion device, a fluid infusion device and a method of manufacturing the same, by hydraulically driving a fluid and by selecting a hydraulic flow rate for dosing a patient. Patent publication number CN107405446B discloses a medical device comprising an infusion device for administration by driving a fluid through a drive wheel, a lead screw and a plunger and engaging the drive wheel through a clutch mechanism to dispense the fluid. While both of the foregoing prior art techniques are capable of achieving dosing, the direct drive fluid infusion to the human body lacks safety constraints and does not meet the safety requirements of special situations, which may include situations where, for example, errors in control instructions result in the infusion of insulin or other medication that may affect patient health and even cause life hazards.

Patent publication CN101808681B discloses a wearable infusion device which establishes a first fluid path between the reservoir and the pump by a first controller when in a first position and a second fluid path between the pump and the outlet when in a second position, and which enables dosing while creating a safety constraint by the second controller only actuating the pump when the first controller has established the second fluid path, however, the infusion device requires simultaneous actuation of both hands to obtain a dosing fluid, which is detrimental to controlling accurate dosing, while its safety constraint is established on an additional interlocking structure, which is detrimental to downsizing the device and simplifying the structure of the device.

Disclosure of Invention

The present disclosure has been made in view of the above-mentioned conventional circumstances, and an object thereof is to provide a flow restriction structure of a medical device, which can be used for fluid delivery, and which can quantitatively control the fluid delivery when the fluid delivery is performed, and which has a simple and reliable safety constraint structure, and which can facilitate simplification of the medical device to increase the space occupation ratio of the fluid storage.

To this end, the present disclosure provides a flow restricting structure of a medical device for delivering a fluid, the flow restricting structure including a flow rate supplier receiving a predetermined volume of the fluid and supplying the predetermined volume of the fluid, a first passage connecting the flow rate supplier, a second passage connecting the flow rate supplier, and a flow restricting valve for controlling opening and closing of the first passage and the second passage, the flow restricting valve having a first through hole and a second through hole, the flow restricting valve changing a direction of the first through hole and the second through hole by rotating a predetermined angle and switching the flow restricting valve between a first state and a second state, the first through hole communicating the first passage and the flow rate supplier, and the second through hole not communicating with the second passage when the flow restricting valve is in the first state; when the restrictor valve is in the second state, the second through hole communicates with the second passage and the flow rate supplier, and the first through hole does not communicate with the first passage.

In this case, the metered fluid delivery is accomplished by the flow feeder in the flow restricting structure receiving and providing a predetermined volume of fluid (e.g. by a change in the flow feeder in the flow restricting structure), i.e. the flow restricting structure is capable of controlling the fluid delivery quantitatively; in addition, in the flow limiting structure, the first channel and the second channel are communicated with the flow supplier, and the opening and closing of the first channel and the second channel are controlled through the flow limiting valve, so that quantitative fluid delivery of the flow supplier can be controlled; in addition, the first through hole and the second through hole of the flow limiting valve are in a first state by rotating the preset angle so as to control the first channel to be communicated with the flow supplier and the second channel to be not communicated with the flow supplier, or the first through hole and the second through hole of the flow limiting valve are in a second state by rotating the preset angle so as to control the second channel to be communicated with the flow supplier and the first channel to be not communicated with the flow supplier, so that a simple and reliable safety constraint structure is formed by utilizing the flow limiting valve, the first channel and the second channel to carry out safety constraint on fluid transportation, and the additional setting of the safety constraint structure can be reduced so as to simplify the medical device to improve the space occupation ratio of fluid storage.

Additionally, in the flow restricting structure of the present disclosure, optionally, when the flow restricting valve is in the first state, the flow feeder maintains a first volume and receives the predetermined volume of fluid via the first channel; when the restrictor valve is in the second state, the flow feeder maintains a second volume and provides the predetermined volume of fluid via the second passage; the second volume is smaller than the first volume, the predetermined volume being determined by a volume difference between the first volume and the second volume. In this case, the flow rate feeder is switched between the first volume and the second volume under the safety constraint of the flow limiting valve, so that the predetermined volume of fluid can be received or provided, and meanwhile, since the second volume is smaller than the first volume, after the flow rate feeder is in the second state, the predetermined volume of fluid positioned in the flow rate feeder can be conveyed to the needle aid through the second channel in a manner of changing the volume of the flow rate feeder, so that the predetermined volume of fluid conveyed to the needle aid is not larger than the first volume, quantitative control can be performed, and the accuracy of conveying the fluid is improved.

In addition, in the flow limiting structure according to the present disclosure, the flow limiting valve may include a cylindrical main body portion and a first connector provided to the main body portion, the first connector being connected to a first driver, and the flow limiting valve may be driven by the first driver to rotate around an axis of the main body portion by the predetermined angle. In this case, the flow limiting valve having the cylindrical main body portion can be easily controlled to rotate; the first driver connected with the first connector of the flow limiting valve drives the flow limiting valve to rotate around the axis of the main body part by a preset angle, and the flow limiting valve can be driven to switch between a first state and a second state, so that the flow limiting valve can be matched with the first channel and the second channel to form a safety constraint structure to carry out safety constraint on fluid transportation, and the safety of fluid transportation is improved.

In addition, in the current limiting structure according to the present disclosure, optionally, the first driver is one of a shape memory alloy, a piezoelectric motor, and a servo motor, and the first connector is one of a torsion spring and a gear. Under the condition, the first driver is the shape memory alloy, so that the reciprocating and accurate stable power source can be conveniently obtained by utilizing the conductive heating shape memory alloy, the convenience of the rotating flow-limiting valve is improved, the first driver is the piezoelectric motor, the rotating precision of the flow-limiting valve can be conveniently improved by utilizing the nanoscale control precision of the piezoelectric motor, and the stability and precision of the rotating flow-limiting valve can be conveniently improved by utilizing the stable moment and high-precision performance of the servo motor; in addition, the first connector is one of a torsion spring and a gear, and can facilitate the transmission of the first driver and the flow limiting valve.

In addition, in the flow restricting structure according to the present disclosure, the first through hole and the second through hole may be formed on a side surface of the main body portion, respectively. In this case, it can be facilitated that the restrictor valve opens the first passage and closes the second passage by rotation or translation or the like, or closes the first passage and opens the second passage, whereby a safety constraint can be formed.

In addition, in the flow limiting structure according to the present disclosure, optionally, the axis of the first through hole is a first axis, the axis of the second through hole is a second axis, and the directions of the first axis and the second axis are different. In this case, it can be facilitated that the flow limiting valve opens the first passage and closes the second passage by rotating, or closes the first passage and opens the second passage, thereby making it possible to form a safety constraint and reducing the situation that the control is inaccurate due to the excessively long fluid path when controlling the opening and closing of the first passage and the second passage in other ways than rotation.

In addition, in the flow limiting structure according to the present disclosure, optionally, a housing accommodating the main body part is further included, the housing includes a sealing material body that encapsulates the main body part and has a sealing effect, and the sealing material body forms a flow channel of the fluid with the first channel and the second channel. In this case, the flow limiting valve structural support can be provided by the housing, and the leakage of the fluid when the flow limiting valve controls the opening and closing of the first channel or the second channel can be reduced by the sealing material, so that the quantitative conveying is inaccurate.

In addition, in the flow restricting structure according to the present disclosure, optionally, the flow rate feeder includes a flow rate feeder body, which is open at one side and sealed by the piston, a piston, and a second connector, and the other side of the flow rate feeder communicates with the second passage. In this case, the flow feeder is capable of changing volume under the action of the piston, thereby being capable of receiving a predetermined volume of fluid or providing a predetermined volume of fluid.

In addition, in the flow restricting structure related to the present disclosure, optionally, the piston is connected with a second driver through the second connector, and the second driver drives the piston to move to switch the volume of the flow rate feeder between the first volume and the second volume. In this case, the volume of the flow rate supplier is switched between the first volume and the second volume by the driving of the second driver, and the flow rate supplier can be made to determine the predetermined volume of the fluid by the difference between the first volume and the second volume, whereby the quantitative control can be performed.

In addition, in the current limiting structure according to the present disclosure, optionally, the second driver is one of a shape memory alloy, a piezoelectric motor, and a servo motor, and the second connector is one of a torsion spring and a gear. In this case, the second driver is a shape memory alloy, which can facilitate the achievement of a reciprocating and accurate stable power source by using the conductive heating shape memory alloy, and the second driver is a piezoelectric motor, which can facilitate the achievement of a predetermined volume of fluid by using the nanoscale control accuracy of the piezoelectric motor, and the second driver is a servo motor, which can facilitate the achievement of a predetermined volume of fluid by using the stable moment and high accuracy performance of the servo motor; in addition, the second connector is one of a torsion spring and a gear, so that the second driver and the flow feeder can be conveniently driven.

According to the present disclosure, a flow restriction structure of a medical device can be provided, the medical device can be used for fluid transport, and when fluid transport is performed, the flow restriction structure can quantitatively control fluid transport.

Drawings

Fig. 1 is a schematic view showing an application scenario of a medical device to which examples of the present disclosure relate.

Fig. 2 is a schematic diagram showing the overall structure of the medical device according to the example of fig. 1 of the present disclosure.

Fig. 3 is a schematic diagram illustrating a connection relationship among a user, a reservoir, and a flow restricting structure according to an example of the present disclosure.

Fig. 4A is a schematic diagram illustrating fluid delivery when a flow restricting structure according to an example of the present disclosure is in a first state.

Fig. 4B is a schematic diagram illustrating fluid delivery when the flow restricting structure according to examples of the present disclosure is in a second state.

Fig. 5 is a schematic diagram showing a structure of a flow limiting valve according to an example of the present disclosure.

Fig. 6 is a schematic structural view showing a main body portion of the flow limiting valve according to the example of the present disclosure.

Fig. 7 is a schematic diagram illustrating the connection of a restrictor valve according to an example of the present disclosure to a first connector for actuation.

Fig. 8 is a schematic diagram showing a structure of a flow rate feeder according to an example of the present disclosure.

Fig. 9A is a schematic diagram illustrating driving of a flow rate feeder connected to a second connector when a flow restricting structure according to an example of the present disclosure is in a first state.

Fig. 9B is a schematic diagram illustrating driving of the flow feeder connected to the second connector when the flow restricting structure according to the example of the present disclosure is in the second state.

Reference numerals illustrate:

1 … … medical device, 2 … … patient, 10 … … housing, 11 … … reservoir, 12 … … flow restricting structure, 13 … … driver, 14 … … controller, 15 … … power source, 16 … … needle assist device, 17 … … filter, 131 … … first driver, 132 … … second driver,

121 … … restrictor valve, 122 … … first passageway, 123 … … flow feeder, 124 … … second passageway, 1211 … … body, 1212 … … first connector, 1213 … … first through hole, 1214 … … second through hole, 1215 … … sealing material body, 1231 … … flow feeder body, 1232 … … piston, 1233 … … second connector, 1234 … … limit projection.

Detailed Description

The following description of the technical solutions in the embodiments of the present disclosure will be made clearly and completely with reference to the accompanying drawings in the embodiments of the present disclosure, and it is apparent that the described embodiments are only some embodiments of the present disclosure, not all embodiments. All other embodiments, which are filled by those of ordinary skill in the art without undue burden based on the embodiments in this disclosure, are within the scope of the present disclosure.

It should be noted that the terms "first," "second," "third," and "fourth," etc. in the description and claims of the present disclosure and in the above figures are used for distinguishing between different objects and not for describing a particular sequential order. Furthermore, the terms "comprise" and "have," as well as any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, system, article, or apparatus that comprises a list of steps or elements is not limited to only those listed or inherent to such process, method, article, or apparatus but may optionally include other steps or elements not listed. In the following description, the same members are denoted by the same reference numerals, and overlapping description thereof is omitted. In addition, the drawings are schematic, and the ratio of the sizes of the components to each other, the shapes of the components, and the like may be different from actual ones.

Fig. 1 is a schematic view showing an application scenario of a medical device 1 according to an example of the present disclosure. Fig. 2 is a schematic diagram showing the overall structure of the medical device 1 according to the example of fig. 1 of the present disclosure. Fig. 3 is a schematic diagram illustrating a connection relationship among a user, a reservoir 11, and a flow restricting structure 12 according to an example of the present disclosure. Wherein the arrows in fig. 3 illustrate the flow direction of the fluid between the reservoir 11, the first channel 122, the flow feeder 123, the second channel 124 and the patient 2, the dashed line section illustrates the control relationship of the restriction valve 121 with the first channel 122, the second channel 124, and the dashed line box illustrates the structural composition of the restriction structure 12.

The present disclosure relates to a flow restricting structure 12 for a medical device 1. As shown in fig. 1, in the present disclosure, a medical device 1 may be used for delivering a fluid, in particular, into a patient 2. The term "user", "patient 2", or "patient" and the like are not intended to be limiting, and the meaning of the foregoing terms may sometimes be equivalent. Likewise, "fluid delivery," "infusion," "injection fluid," and the like are not intended to be limiting, and are to be interpreted in the same or similar sense, unless specifically limited. The medical device 1 may be an external non-application type device, for example, an insulin pump applied to the surface of the human body as shown in fig. 1, which infuses insulin into the human body through an injection needle tube, or a non-application type device may be a suspended insulin pump, or the like. In other examples, the medical device 1 may be configured as a subcutaneous or intracorporal device, and the housing may be formed into a specific shape using a biocompatible material, such as an implantable analgesic pump, a hepatic vascular fully implantable drug pump, or the like, for devices that are adapted to different body parts.

As shown in fig. 2, in some examples, the medical device 1 may include a housing 10, a reservoir 11, a flow restricting structure 12, a driver 13, a controller 14, and a power source 15, among others.

In some examples, the housing 10 may house internal components such as the reservoir 11, the flow restricting structure 12, and the driver 13 and may be used to protect these internal components.

In some examples, the reservoir 11 may be used to store a fluid. In some examples, the flow restricting structure 12 may include a flow restricting valve 121, a first passage 122, a second passage 124, a flow feeder 123, etc., and the flow restricting structure 12 may be used to restrict flow and create a safety restriction when fluid is delivered (see in particular the description of the flow restricting structure 12 later).

In some examples, driver 13 may include a first driver 131 and a second driver 132 (described later), and driver 13 may be used to drive current limiting structure 12.

In some examples, the controller 14 may issue control instructions to control the driver 13 based on the control signals.

In some examples, as shown in fig. 3, in the medical device 1 to which the present disclosure relates, the first channel 122 may be in communication with the reservoir 11, and the flow feeder 123 may be configured to receive fluid from the reservoir 11 and provide the fluid via the first channel 122.

In some examples, the power supply 15 may be used to power the driver 13. Specifically, the driver 13 may control the state of the restriction valve 121 and may control the volume change of the flow supplier 123, the second channel 124 may communicate with the flow supplier 123 and receive fluid from the flow supplier 123 and be percutaneously inserted into the body, and the restriction valve 121 may be driven by the driver 13 to control the opening and closing of the first channel 122 and the opening and closing of the second channel 124.

Referring to fig. 2, in some examples, the medical device 1 may further comprise a needle aid 16 and a filter 17. The needle aid 16 may be used to insert an extension of the second channel 124 subcutaneously to facilitate infusion of fluid into the body through the second channel 124. The filter 17 may be disposed between the reservoir 11 and the first channel 122 to filter the fluid to reduce the possible blockage (e.g. insulin or other drugs) caused by crystallization of the fluid, so that the fluid can smoothly flow into the flow supplier 123, and the accuracy of fluid infusion into the human body is improved.

Further, in the present disclosure, the fluid is not particularly limited, and may be, for example, a drug solution infused by the medical device 1 according to the present disclosure, and in some examples, such a drug solution may be dopamine, dobutamine, epinephrine, norepinephrine bitartrate, sodium nitroprusside, shitannate, propofol, insulin, glucagon-like peptide-1, or the like. In addition, the medical device 1 according to the present disclosure may also be used for periodic, continuous and accurate administration of drugs to the patient 2 in connection with the actual situation of any disease.

In addition, in any embodiment of the present disclosure, "receiving a predetermined volume of fluid" may refer to receiving, accepting, obtaining, or acquiring a predetermined volume of fluid, in a manner that may include, but is not limited to, inflow, squeeze-in, inhalation, or pumping, etc.; "providing a predetermined volume of fluid" may refer to providing or evacuating a predetermined volume of fluid from the flow feeder 123, and may include, but is not limited to, flowing out, squeezing, sucking out, pumping out, or the like.

Fig. 4A is a schematic diagram illustrating fluid delivery with the flow restricting structure 12 according to examples of the present disclosure in a first state. Fig. 4B is a schematic diagram illustrating fluid delivery when the flow restricting structure 12 in accordance with examples of the present disclosure is in a second state.

As described above, the flow restricting structure 12 according to the present disclosure may include the flow rate supplier 123, the first passage 122, the second passage 124, and the flow restricting valve 121. In some examples, the flow feeder 123 may receive a predetermined volume of fluid and provide a predetermined volume of fluid. In some examples, the first channel 122 may be connected to a flow feeder 123. In some examples, the second channel 124 may be connected with the flow feeder 123. In some examples, the restrictor valve 121 may be used to control the opening and closing of the first and second channels 122, 124. In this case, a predetermined volume of fluid is received and provided by the flow feeder 123 in the flow restricting structure 12, a quantitative fluid delivery can be accomplished, i.e. the flow restricting structure 12 can quantitatively control the fluid delivery; in addition, in the flow restriction structure 12, the flow restriction valve 121 controls the opening and closing of the first passage 122 and the second passage 124, so that a safety restriction is formed to enhance the safety of fluid delivery when the fluid is quantitatively delivered in cooperation with the flow rate supplier 123.

As shown in fig. 4A and 4B, in some examples, the restrictor valve 121 may have a first state and a second state.

In some examples, the restrictor valve 121 may be switched between the first state and the second state by rotating a predetermined angle. Specifically, the flow limiting valve 121 may have a first through hole 1213 and a second through hole 1214, and the flow limiting valve 121 may change the direction of the axis of the first through hole 1213 and the direction of the axis of the second through hole 1214 by rotating a predetermined angle, and may switch the flow limiting valve 121 between a first state and a second state, for example, the flow limiting valve 121 may rotate a first predetermined angle to the first state and a second predetermined angle to the second state, the first predetermined angle and the second predetermined angle may be two predetermined angles having equal and opposite magnitudes, and the first predetermined angle and the second predetermined angle may also be two predetermined angles having the same direction and having magnitudes set according to the size and driving manner of the flow limiting valve 121. That is, in some examples, the predetermined angle may be understood as being set according to the size and driving manner of the restriction valve 121.

In some examples, the predetermined angle by which the restrictor valve 121 rotates may refer to an angle that is required to rotate when the first passage 122 is opened and the second passage 124 is closed, or when the first passage 122 is closed and the second passage 124 is opened.

In other examples, restrictor valve 121 may also have multiple states. For example, the restrictor valve 121 may have a third state and the restrictor valve 121 may be in the third state upon occurrence of a safety event, such as a condition in which the fluid received or provided by the flow feeder 123 does not meet a predetermined volume or in which the flow feeder 123 is unable to receive or provide a predetermined volume of fluid, neither the first channel 122 nor the second channel 124 is in communication with the flow feeder 123 when the restrictor valve 121 is in the third state, in which case the volume of fluid that can reduce an infusion error upon occurrence of a safety event results in an inaccurate or life threatening condition for the patient 2. In some examples, the plurality of states of the restrictor valve 121 may be formulated as desired, and may include a first state, a second state, a third state, a fourth state, or more.

Fig. 5 is a schematic diagram showing the structure of the restrictor valve 121 according to the example of the present disclosure. Fig. 6 is a schematic diagram showing the structure of the main body 1211 of the restrictor valve 121 according to the example of the present disclosure. It should be noted that the connection of the restrictor valve 121 to the first and second channels 122, 124 is also illustrated in fig. 5.

As shown in fig. 5, in the present disclosure, the restrictor valve 121 may include a body portion 1211 and a first connector 1212. In some examples, the body portion 1211 may connect the first channel 122 and the second channel 124, and may control opening and closing of the first channel 122 and the second channel 124.

As shown in fig. 7, in some examples, the body portion 1211 may be cylindrical. In this case, the main body 1211 has a cylindrical flow restrictor 121, which can be controlled to rotate. In some examples, the restrictor valve 121 may have a first through hole 1213 and a second through hole 1214, and in particular, the first through hole 1213 and the second through hole 1214 may be provided to the body portion 1211. In this case, it can be convenient to communicate the flow supplier 123 in cooperation with the first passage 122 or the second passage 124 to form a safety restraint structure, improving the safety of fluid transportation.

In some examples, the first through hole 1213 may be formed at a side surface of the main body portion 1211. In some examples, the second through hole 1214 may also be formed at a side of the body portion 1211. In some examples, the first through hole 1213 and the second through hole 1214 may not communicate with each other. In this case, it can be convenient for the restrictor valve 121 to open the first passage 122 and close the second passage 124 by rotation or translation or the like, or to close the first passage 122 and open the second passage 124, whereby a safety constraint can be formed. For example, when the first through hole 1213 and the second through hole 1214 are spatially non-communicating with each other and the axes are orthogonal to each other (i.e., different surfaces), the flow limiting valve 121 may be rotated to control the opening and closing of the first passage 122 and the second passage 124 (i.e., whether to communicate with the flow rate supplier 123). For example, when the spaces of the first through hole 1213 and the second through hole 1214 are not communicated with each other and the axes are parallel to each other, the flow limiting valve 121 may be translated to control the opening and closing of the first channel 122 and the second channel 124.

In some examples, the predetermined angle by which the restrictor valve 121 rotates may refer to an angle formed by rotating the axis of the first through hole 1213 and the axis of the second through hole 1214, and rotating the angle can cause the first channel 122 to open and the second channel 124 to close, or cause the first channel 122 to close and the second channel 124 to open. The predetermined angle may not be limited, for example, may be any angle greater than 15 degrees and less than 180 degrees, according to the process and actual operation needs, but in the present disclosure, preferably, the predetermined angle may be 45 degrees, 90 degrees, or 135 degrees.

In some examples, the rotation of the restrictor valve 121 may be unidirectional or may be reciprocally rotated. Preferably, embodiments of the present disclosure employ a reciprocating rotation.

In the present disclosure, in order to save space and reduce the case where the excessive length of the fluid path when controlling the opening and closing of the first and second passages 122 and 124 in other ways than rotation causes inaccurate control, it is preferable to control the opening and closing of the first and second passages 122 and 124 by rotating the flow limiting valve 121. That is, the axis of the first through hole 1213 may be defined as a first axis, the axis of the second through hole 1214 may be defined as a second axis, and the directions of the first axis and the second axis may be different. In this case, it can be facilitated that the flow limiting valve 121 rotationally opens the first passage 122 and closes the second passage 124, or closes the first passage 122 and opens the second passage 124, whereby a safety constraint can be formed and a situation in which the fluid path is excessively long when the opening and closing of the first passage 122 and the second passage 124 are controlled in other ways than rotation, resulting in inaccurate control, can be reduced.

It should be noted that "the fluid path is too long when the first channel 122 and the second channel 124 are opened or closed" may be understood as the path length of the fluid in the cut-off region when the first channel 122 and the second channel 124 are opened or closed, and generally, the longer the path of the fluid in the cut-off region, the more complex the calculation of the volume of the fluid in the cut-off region is, which is disadvantageous for precise control and improvement of the tightness, for example, reference may be made to the distinction between the spool valve and the rotary valve in industrial production.

Specifically, referring to fig. 4A, when the restrictor valve 121 is in the first state, the first through hole 1213 communicates with the first passage 122 and the flow supplier 123, and the second through hole 1214 does not communicate with the second passage 124; referring to fig. 4A, when the restriction valve 121 is in the second state, the second through hole 1214 communicates with the second passage 124 and the flow rate supplier 123, and the first through hole 1213 does not communicate with the first passage 122. In this case, by rotating the first through hole 1213 and the second through hole 1214 of the restriction valve 121 by a predetermined angle to be in the first state, or by rotating the first through hole 1213 and the second through hole 1214 of the restriction valve 121 by a predetermined angle to be in the second state, to control whether the first passage 122 and the second passage 124 communicate with the flow supplier 123, that is, by forming a simple and reliable safety restriction structure for fluid delivery using the restriction valve 121, the first passage 122 and the second passage 124, additional safety restriction structures can be reduced, whereby simplification of the medical device 1 to increase the space occupation of fluid storage can be facilitated. In some examples, the space occupation of the fluid storage may be increased by simplifying the medical device 1, thereby enabling a reduction in the manufacturing costs of the medical device 1.

In some examples, the predetermined volume of fluid may also be referred to as a unit, base, or digital amount of fluid, and the predetermined volume of fluid may be determined by varying the first volume or the second volume of the flow feeder 123 according to different fluid types and therapeutic effects, e.g., a specific therapeutic effect may be achieved according to the needs of a diabetic patient, and the amount of insulin per time a predetermined volume may be set to 0.1mg (or ml), 0.5mg (or ml), 1mg (or ml), etc.

In some examples, the body portion 1211 may be formed of a plurality of cylinders in a cylindrical shape, for example, may be formed by coaxially combining a plurality of cylinders, and the diameters of the two cylinders are different. In this case, it can be convenient to provide corresponding members or through holes on a particular right circular cylinder, for example, first through holes 1213 and second through holes 1214 may be provided on a larger diameter cylinder, and connecting members or driving members may be provided on a smaller diameter cylinder.

Fig. 7 is a schematic diagram showing the connection of the restrictor valve 121 according to the example of the present disclosure with the first connector 1212 for driving. It should be noted that the connection of the restrictor valve 121 to the first and second channels 122, 124 is also illustrated in fig. 7.

As described above, in some examples, the restrictor valve 121 may include a first connector 1212. As shown in fig. 7, in some examples, the first connector 1212 may be provided on the main body portion 1211. Specifically, the first connector 1212 may be disposed on a smaller diameter cylinder of the main body 1211. In some examples, the first connector 1212 may be connected with the first driver 131 of the medical device 1, and the restrictor valve 121 is driven by the first driver 131 to rotate a predetermined angle around the axis of the main body 1211. In this case, the first driver 131 connected to the first connector 1212 of the restrictor valve 121 drives the restrictor valve 121 to rotate around the axis of the main body 1211 by a predetermined angle, so that the restrictor valve 121 can be driven to switch between the first state and the second state, and thus the restrictor valve 121 can be used to form a safety restriction structure in cooperation with the first channel 122 and the second channel 124 to safely restrict fluid transportation, so as to improve the safety of fluid transportation.

In some examples, the first driver 131 of the medical device 1 may be a shape memory alloy. In this case, the shape memory alloy of the first driver 131 can facilitate the convenience in using the conductive heating shape memory alloy to obtain a reciprocating and accurate stable power source to raise the rotary restrictor valve 121.

In some examples, the first driver 131 of the medical device 1 may be a piezoelectric motor. In this case, the first driver 131 can facilitate the improvement of the accuracy of the rotation of the flow restriction valve 121 with the control accuracy of the piezoelectric motor on the nano scale for the piezoelectric motor.

In some examples, the first driver 131 of the medical device 1 may be in a servo motor. In this case, the first driver 131 is a servo motor capable of facilitating stable torque and high precision performance of the servo motor to improve stability and precision of rotation of the flow restriction valve 121.

In some examples, the first connector 1212 may be one of a torsion spring, a gear. In this case, the first connector 1212 is one of a torsion spring and a gear that can facilitate transmission of the first driver 131 with the restrictor valve 121.

It should be noted that, in other examples, the first driver 131 and the first connector 1212 may not be limited to the foregoing embodiments, for example, the first driver 131 may be other more precise power devices or structures, such as a micro stepping motor, etc.

In some examples, the flow restricting structure 12 may also include a housing that houses the body portion 1211. In this case, the restrictor valve 121 structural support can be provided by the housing.

In some examples, the housing may include a sealing material body 1215, and the sealing material body 1215 may encase the body portion 1211 and have a sealing effect. The sealing material body 1215 may also form a channel with the first and second channels 122, 124 for fluid flow. In this case, the leakage of the fluid when the flow limiting valve 121 controls the opening and closing of the first passage 122 or the second passage 124 can be reduced by the sealing material body 1215, resulting in inaccurate metering. In some examples, the materials of the sealing material 1215, the first channel 122, and the second channel 124 may be optionally the same material, such as silicone, or may be formed of different materials according to different designs, such as a biocompatible material, such as polypropylene, silicone, polyurethane, acrylic derivatives, polyhydroxy acids, etc., for the portion of the second channel 124 that is implanted in the patient.

Fig. 8 is a schematic diagram showing the structure of the flow rate supplier 123 according to the example of the present disclosure.

As described above, the flow restricting structure 12 may include a flow feeder 123. As shown in fig. 8, in some examples, the flow feeder 123 may be a container that communicates with the first channel 122 and the second channel 124, and the volume of the flow feeder 123 may vary. Specifically, referring to fig. 4A, when the restrictor valve 121 is in the first state, the flow feeder 123 may hold the first volume and receive a predetermined volume of fluid via the first channel 122; referring to fig. 4B, when the restrictor valve 121 is in the second state, the flow supplier 123 may maintain the second volume and provide a predetermined volume of fluid via the second channel 124. In this case, the fluid of a predetermined volume can be received or supplied by switching between the first volume and the second volume through the flow supplier 123 under the safety constraint of the flow limiting valve 121, thereby enabling quantitative control and improving the accuracy of fluid delivery.

In some examples, the second volume may be smaller than the first volume, the predetermined volume being determined by a volume difference between the first volume and the second volume, e.g., the predetermined volume may be a volume difference between the first volume and the second volume.

Specifically, referring to fig. 8, the flow feeder 123 may include a flow feeder body 1231, a piston 1232, and a second connector 1233.

In some examples, one side of the flow feeder body 1231 may be open and may be sealed by a piston 1232, and the other side of the flow feeder body 1231 may be in communication with the second passage 124. Specifically, one side of the flow feeder body 1231 may be connected with the piston 1232, while the remaining side may be in communication with either the first passage 122 or the second passage 124, the second passage 124 being disposed on the opposite side of the piston 1232 in order to facilitate the discharge of the fluid of the flow feeder body 1231. In this case, the flow supplier 123 can change its volume by the piston 1232, thereby being able to receive a predetermined volume of fluid or provide a predetermined volume of fluid.

In some examples, the flow feeder body 1231 creates a negative pressure and may draw in fluid through the first passage 122 during the switching to the first volume by the piston 1232, the flow feeder body 1231 creates a positive pressure and may expel fluid through the second passage 124 during the switching to the second volume by the piston 1232, and the volume of the fluid, i.e., the predetermined volume, is determined by controlling the volume difference between the first volume and the second volume.

Fig. 9A is a schematic diagram showing driving of the flow rate supplier 123 connected to the second connector 1233 when the flow restricting structure 12 according to the example of the present disclosure is in the first state. Fig. 9B is a schematic diagram showing that the flow rate supplier 123 is connected to the second connector 1233 to be driven when the flow restricting structure 12 according to the example of the present disclosure is in the second state.

As described above, the medical device 1 may include the second driver 132. As shown in fig. 9A and 9B, in some examples, the piston 1232 may be connected with the second driver 132 of the medical device 1 through a second connector 1233, and the second driver 132 drives the piston 1232 to move. Specifically, the second driver 132 may drive the piston 1232 to move to switch the volume of the flow feeder 123 between the first volume and the second volume, e.g., the flow feeder 123 remains in the first volume when the piston 1232 moves in the Z1 direction, and the flow feeder 123 switches from the first volume to the second volume when the piston 1232 moves in the Z2 direction. In this case, the volume of the flow rate supplier 123 is switched between the first volume and the second volume by the driving of the second driver 132, and the flow rate supplier 123 can be made to determine a predetermined volume of fluid by the difference between the first volume and the second volume, whereby quantitative control can be performed.

In some examples, the second driver 132 may be a shape memory alloy. In this case, the second driver 132 is a shape memory alloy capable of facilitating the convenience in controlling the flow rate supplier 123 by using a power source that heats the shape memory alloy with conduction to obtain reciprocation and precision stabilization.

In some examples, the second driver 132 of the medical device 1 may be a piezoelectric motor. In this case, the second driver 132 can facilitate the accuracy of obtaining a predetermined volume of fluid by the flow supplier 123 with the control accuracy of the piezoelectric motor on the nanometer scale.

In some examples, the second driver 132 of the medical device 1 may be a servo motor. In this case, the second driver 132 can facilitate the stabilization moment and high precision performance of the servo motor to improve the stability and precision of the fluid of the predetermined volume obtained by the flow supplier 123 for the servo motor.

In some examples, the second connector 1233 of the medical device 1 may be one of a torsion spring, a gear. In this case, the second connector 1233 is one of a torsion spring and a gear, which can facilitate the transmission of the second driver 132 and the flow rate supplier 123.

It should be noted that, in other examples, the second driver 132 and the second connector 1233 may not be limited to the foregoing embodiments, for example, the second driver 132 may be other more precise power devices or structures, such as a micro stepping motor, etc.

In some examples, the second driver 132 and the first driver 131 may be simultaneously controlled, that is, when the first driver 131 controls the flow limiting valve 121 to open and close the first passage 122 or open and close the second passage 124, the second driver 132 simultaneously controls the volume change of the flow supplier 123 to switch the volume of the flow supplier 123 between the first volume and the second volume. In this case, the simultaneous control can reduce the time for fluid infusion into the body and reduce the number of time-series inputs of control instructions, whereby the control program of the control chip can be simplified, and thus the treatment of the patient can be speeded up.

In some examples, the second driver 132 and the first driver 131 may be time-lapse control, that is, when the first driver 131 controls the flow restriction valve 121 to open and close the first passage 122 or open and close the second passage 124, the second driver 132 controls the volume change of the flow rate supplier 123 to switch the volume of the flow rate supplier 123 between the first volume and the second volume following the control of the flow restriction valve 121 by the first driver 131. In this case, the delay control can improve the accuracy of control, and reduce the occurrence of errors in control timing, resulting in poor therapeutic effect.

In some examples, to ensure accuracy of the volume change of the flow feeder 123, a plurality of limit protrusions 1234 may also be provided in the flow feeder body 1231. In this case, when the piston 1232 reciprocates in the flow rate supplier 123 to change the volume of the flow rate supplier 123, the limiting projection 1234 can limit the piston 1232, improving the accuracy of the volume change of the flow rate supplier 123. In other examples, the limit projection 1234 may not be provided, i.e., the limit projection 1234 is not necessary, and the flow feeder 123 may limit the volume change by the inner wall and the piston 1232, e.g., the flow feeder body 1231 may have a first volume zero by abutting the piston 1232 at the inner wall communicating the first passage 122 and the second passage 124, and thereafter a second volume may be formed by changing the position of the piston 1232.

In other examples, the flow feeder body 1231 may also be a collapsible container formed of an elastomeric material that can be stretched to a predetermined degree and negative pressure when fluid fill is desired and retracted to allow fluid to be expelled when fluid removal is desired. In this case, the setting of the piston 1232 and the second connector 1233 can be reduced.

As described above, the flow restricting structure 12 may include a first passage 122 and a second passage 124. Referring to fig. 5, in some examples, the first and second passages 122, 124 may form a fluid flow channel with the sealing material body 1215, and the first and second passages 122, 124 may also communicate with the flow feeder 123 and be opened or closed under the control of the restrictor valve 121. In this case, the opening and closing of the first and second passages 122 and 124 can be controlled by the restriction valve 121 to control the fluid flowing in the chamber to enter or exit the flow rate supplier 123, whereby the effect of safely transporting the fluid can be achieved.

In some examples, the diameters of the first and second channels 122, 124 may be the same, e.g., the diameters of the first and second channels 122, 124 may each be 0.7mm or less (also commonly referred to as micro-or capillary diameters). In this case, the same pressure drop can be maintained when delivering the fluid by the first and second passages 122, 124 having the same diameter of 0.7mm or less, so that the delivery process is stable and accurate. In other examples, the diameters of the first and second channels 122, 124 may be different, for example, because the second channel 124 is partially required to enter the subcutaneous tissue of the human body, and thus may be slightly smaller than the tube diameter of the first channel 122, for example, the second channel 124 may be less than 0.5mm in diameter to facilitate fluid delivery.

In some examples, the materials of the first channel 122 and the second channel 124 may alternatively be the same material, for example, a hard metal (such as copper tube) or a non-gold material (such as plastic tube), which is not easily broken to make the fluid flow therein more stable, or a soft non-gold material (such as silica gel), which is easily bent to facilitate the arrangement of other components in the medical device 1.

In some examples, the materials of the first channel 122 and the second channel 124 may alternatively be configured with different materials according to different designs, for example, the portion of the second channel 124 implanted in the patient may be made of a material with better biocompatibility, such as polypropylene, silicone, polyurethane, acrylic derivatives, polyhydroxy acids, etc., while the first channel 122 may not be made of a material with better biocompatibility because it is mounted inside the medical device 1 and not in contact with the human body.

As described above, in some examples, the medical device 1 to which the present disclosure relates may include a reservoir 11 for containing or storing a fluid. Referring to fig. 2 or 3 previously described, in some examples, the first channel 122 may be in communication with the reservoir 11, and the flow supply 123 may be configured to receive fluid from the reservoir 11 and provide the fluid via the first channel 122. Specifically, the reservoir 11 may store a large amount of fluid for delivery, and the flow supplier 123 may obtain a predetermined volume of fluid from the reservoir 11 through the first passage 122 when switching different volumes, thereby achieving quantitative fluid acquisition.

In some examples, the second channel 124 may be in communication with the flow provider 123 and receive fluid from the flow provider 123 and percutaneously access the body. Specifically, after the flow rate supplier 123 switches a different volume and obtains a predetermined volume of fluid from the reservoir 11 through the first passage 122, the flow rate supplier 123 switches again to discharge and deliver the obtained predetermined volume of fluid to the human body via the second passage 124.

In some examples, the first channel 122 and the second channel 124 may be disposed in parallel. In this case, it is possible to facilitate the flow limiting valve 121 to open the first passage 122 and close the second passage 124 by rotating, or to close the first passage 122 and open the second passage 124, thereby making it possible to form a safety constraint and reducing the situation that the control is inaccurate due to the excessively long fluid path when controlling the opening and closing of the first and second passages in other ways than rotating, and in addition, the first and second passages 122 and 124 are arranged in parallel, and it is also possible to facilitate the reduction of the space occupation when the first and second passages 122 and 124 are arranged in the medical device 1.

In some examples, the first and second channels 122, 124 may also be disposed non-parallel in some examples, e.g., the first and second channels 122, 124 may be disposed off-plane (i.e., spatially orthogonal).

As described above, referring to fig. 2 previously described, in some examples, the medical device 1 to which the present disclosure relates may include a filter 17 disposed between the reservoir 11 and the first channel 122, and the first channel 122 may extract filtered fluid from the reservoir 11 under the influence of the filter 17. In this case, it is possible to reduce the occurrence of clogging (e.g., medicines such as insulin) when the fluid may crystallize, thereby enabling smooth flow of the fluid into the flow rate supplier 123 and improving the accuracy of fluid infusion into the patient. In other examples, the medical device 1 may not be provided with the filter 17, for example, the filter 17 may not be provided when the fluid is a liquid medicine that is not easily crystallized.

As described above, referring to fig. 2 previously described, in some examples, the medical device 1 to which the present disclosure relates may include a needle aid 16, and the second channel 124 may be subcutaneously inserted with the aid of the needle aid 16. In this case, the medical device 1 is able to infuse fluid into the body through the second channel 124. In some examples, the inserted subcutaneous portion of the needle assist 16 may be a needle or trocar and the needle assist 16 may deliver the second channel 124 subcutaneously in a single pass and withdraw the needle or trocar leaving the second channel 124 partially subcutaneously. In this case, the medical device 1 can infuse fluid into the body through the second channel 124 and can reduce pain of multiple needle sticks for the patient.

According to the present disclosure, a flow restriction structure 12 of a medical device 1 can be provided, the medical device 1 can be used for fluid delivery, the flow restriction structure 12 can quantitatively control the fluid delivery when the fluid delivery is performed, in addition, the flow restriction structure 12 has a simple and reliable safety constraint structure, and can facilitate simplification of the medical device 1 to promote the space occupation ratio of the fluid storage and reduce the manufacturing cost.

While the disclosure has been described in detail in connection with the drawings and examples, it is to be understood that the foregoing description is not intended to limit the disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as required without departing from the true spirit and scope of the disclosure, and such modifications and variations are within the scope of the disclosure.

Claims (10)

1. A flow restricting structure of a medical device for delivering a fluid, characterized by comprising a flow rate supplier for receiving a predetermined volume of the fluid and supplying the predetermined volume of the fluid, a first passage connected to the flow rate supplier, a second passage connected to the flow rate supplier, and a flow restricting valve for controlling opening and closing of the first passage and the second passage,

The flow limiting valve has a first through hole and a second through hole, changes the direction of the axis of the first through hole and the direction of the axis of the second through hole by rotating a predetermined angle and switches the flow limiting valve between a first state and a second state,

when the restrictor valve is in the first state, the first through-hole communicates with the first passage and the flow-rate supplier, and the second through-hole does not communicate with the second passage;

when the restrictor valve is in the second state, the second through hole communicates with the second passage and the flow rate supplier, and the first through hole does not communicate with the first passage.

2. The flow restricting structure of claim 1, wherein,

when the restrictor valve is in the first state, the flow feeder maintains a first volume and receives the predetermined volume of fluid via the first channel;

when the restrictor valve is in the second state, the flow feeder maintains a second volume and provides the predetermined volume of fluid via the second passage;

the second volume is smaller than the first volume, the predetermined volume being determined by a volume difference between the first volume and the second volume.

3. The flow restricting structure of claim 1, wherein,

the flow limiting valve comprises a cylindrical main body part and a first connector arranged on the main body part, wherein the first connector is connected with a first driver, and the flow limiting valve is driven by the first driver to rotate around the axis of the main body part by the preset angle.

4. A flow restricting structure as defined in claim 3, wherein,

the first driver is one of a shape memory alloy, a piezoelectric motor and a servo motor, and the first connector is one of a torsion spring and a gear.

5. A flow restricting structure as defined in claim 3, wherein,

the first through holes and the second through holes are not communicated with each other, and the first through holes and the second through holes are respectively formed on the side face of the main body part.

6. The flow restricting structure of claim 1, wherein,

the axis of the first through hole is a first axis, the axis of the second through hole is a second axis, and the directions of the first axis and the second axis are different.

7. A flow restricting structure as defined in claim 3, wherein,

the sealing device comprises a main body part, and is characterized by further comprising a shell for accommodating the main body part, wherein the shell comprises a sealing material body which covers the main body part and has a sealing effect, and the sealing material body, the first channel and the second channel form a flow channel of the fluid.

8. The flow restricting structure of claim 1, wherein,

the flow feeder includes a flow feeder body, which is open at one side and sealed by a piston, and a second connector, the other side of which communicates with the second passage.

9. The flow restricting structure of claim 8, wherein,

the piston is connected to a second driver through the second connector and the second driver drives the piston to move to switch the volume of the flow feeder between the first volume and the second volume.

10. The flow restricting structure of claim 9, wherein,

the second driver is one of a shape memory alloy, a piezoelectric motor and a servo motor, and the second connector is one of a torsion spring and a gear.