WO2016188425A1

WO2016188425A1 - Flow regulating device, fluid infusion apparatus, and manufacturing method therefor

Info

Publication number: WO2016188425A1
Application number: PCT/CN2016/083282
Authority: WO
Inventors: 冯勇; 薛跃强; 黄霖; 宗·科林·安东尼
Original assignee: 美敦力公司; 美敦力（上海）有限公司
Priority date: 2015-05-25
Filing date: 2016-05-25
Publication date: 2016-12-01
Also published as: CN106267458A

Abstract

A flow regulating device (1) used in a fluid infusion apparatus used for administering a medicament to a patient, the flow infusion apparatus having the flow regulating device (1) and used for administering the medicament to the patient, and a manufacturing method for the device and the apparatus. The flow regulating device (1) comprises: multiple fluid channels (11) used for delivering a fluid, an inlet pipe (12) in communication with inlets of the multiple flow channels (11), an outlet pipe (13) for outputting the fluid in the multiple fluid channels (11), and a flow selecting mechanism (14) between the inlet channel (12) and the outlet channel (13) of the multiple flow channels (11). The flow regulating device (1) comprises: multiple fluid channels (11) used for delivering a fluid, an inlet pipe (12) in communication with inlets of the multiple flow channels (11), an outlet pipe (13) for outputting the fluid in the multiple fluid channels (11), and a flow selecting mechanism (14) between the inlet channel (12) and the outlet channel (13) of the multiple flow channels (11). The flow rate selecting mechanism (14) is configured to select some of the fluid channels (11) among the multiple flow channels (11) to be in communication with the outlet pipe (13). By means of the flow rate regulating device (1), the fluid infusion apparatus, and the method therefor, selection of the flow rate of the fluid channels is allowed, thus acquiring different flow rates.

Description

Flow regulating device, fluid infusion device and manufacturing method thereof

This application claims priority to Chinese Patent Application No. 201510270538.9, entitled "Flow Regulator, Fluid Infusion Equipment and Method of Manufacturing", filed on May 25, 2015, the entire contents of which are filed on May 25, 2015. This is incorporated herein by reference.

Technical field

The present invention relates to the field of fluid delivery, and in particular to a flow regulating device for use in a fluid infusion device for administering a patient, and a fluid infusion device with the flow regulating device and their manufacture method.

Background technique

Diabetes is a metabolic disease characterized by high blood sugar. Hyperglycemia is generally caused by defects in insulin secretion or its biological effects, or a combination of both. The long-term presence of hyperglycemia in diabetic patients can cause chronic damage and dysfunction in multiple body organs (eg, eyes, kidneys, heart, blood vessels, nervous system, etc.).

The clinical diagnosis of diabetes can be divided into type 1 diabetes and type 2 diabetes. Type 1 diabetes, also known as insulin-dependent diabetes, is usually a disease inherited by a congenital family. Type 1 diabetes is an autoimmune disease in which the body's immune system attacks the beta cells that produce insulin in the body, ultimately leading to the inability to produce insulin in the body. Such patients need to be injected with exogenous insulin to control blood sugar levels in the body. Type 1 diabetes patients typically require 24-hour exposure to an electronic insulin pump, such as the Medtronic Minimed insulin pump. Type 2 diabetes, also known as non-insulin-dependent diabetes, is generally caused by adults, especially obese people, whose condition can lead to weight loss. Possible causes include: insulin resistance, which prevents the body from using insulin effectively; the reduction in insulin secretion does not meet the body's needs. Early type 2 diabetes patients can control and even cure diabetes by improving their lifestyles (eg, healthy eating, moderate exercise, safe weight loss, smoking cessation, and avoidance of secondhand smoke).

The existing insulin pumps for patients with type 2 diabetes have both electronic and mechanical insulin pumps. Both insulin pumps require both basal and pill injections. For electronic insulin pumps, the basic amount of injection is generally controlled by a stepper motor, directly Push the piston for drug delivery. For mechanical insulin pumps, the basic volume injection generally reduces the flow of liquid from the drug capsule by various means, and achieves a continuous microinfusion by limiting the flow rate. However, conventional mechanical insulin pumps usually only have a speed control of the basic amount of injection, which cannot meet the demand for insulin intake of diabetic patients at different times of the day or different daily catering structures.

Summary of the invention

In order to solve the above technical problems, the present invention provides a flow regulating device used in a fluid infusion device for administering a patient, an infusion device with the same, and a method of manufacturing the same The flow rates of a part of the plurality of fluid passages or all of the fluid passages are configured to be different from each other, and then a part of the fluid passages and outlets of the plurality of fluid passages are selected by a flow selecting mechanism disposed between the outlet and outlet ducts of the plurality of fluid passages The pipes are connected and a variety of different flow options are obtained using mechanical structures.

According to a first aspect of an embodiment of the present invention, there is provided a flow regulating device for use in a fluid infusion device for administering a patient, the device comprising: a plurality of fluid passages for delivering fluid and configuring Having a flow rate of fluid flowing through a portion of the plurality of fluid passages or all of the fluid passages different from each other; an inlet conduit communicating with an inlet of the plurality of fluid passages for conveying the fluid to the a plurality of fluid passages; an outlet conduit for outputting fluid delivered in the plurality of fluid passages; a flow selection mechanism disposed between the outlets of the plurality of fluid passages and the outlet conduit and configured to select the A portion of the plurality of fluid passages are in communication with the outlet conduit.

In some embodiments, the plurality of fluid channels can be disposed on a single layer of chip. The chip may be made of a material such as glass, resin or other polymer material, and the shape of the chip may be various, for example, rectangular, square, circular, or the like. Moreover, the fluid passages on the chip can be made by cutting (for example, laser cutting, etc.) or etching, for example, an open channel cut into a groove shape. Of course, the fluid channel can also be a closed channel embedded in the chip. The width or depth of the fluid passage may range from 5 μm to 100 μm. The plurality of fluid channels can be arranged on the chip in various different ways. For example, the plurality of channels can be arranged in a parallel linear manner on the chip, and the plurality of channels can also be arranged on the chip in a curved or coiled manner to the center of the chip. The center of the circle is arranged in a concentric disc, and is arranged radially in the radial direction with the center of the chip as a center, and may also be radially arranged at a point other than the center of the chip. According to the arrangement of the fluid channel on the chip, The inlet and outlet positions of the plurality of fluid passages, the length of the passage, and the like are set accordingly.

In some embodiments, the flow selecting mechanism can include: a passage communication member on the single layer chip and above an outlet of the plurality of fluid passages, having an outlet capable of respectively separating the plurality of fluid passages a plurality of selection passages in communication with the outlet duct; a passage switch member engaged with the passage communication member and configured to selectively open or close the selection passage.

In some embodiments, the plurality of selection channels may be a plurality of through holes disposed on the channel communication member, for example, the number of through holes may be equal to the number of selected channels.

In some embodiments, the channel switch component may include: a sealing film overlying a plurality of through holes of the channel communication member; a plurality of selection buttons corresponding to the plurality of through holes and located in the seal Above the film, each of the plurality of selection buttons has a protrusion that matches a through hole in the channel communication member, and the protrusion is configured to be engageable with the through hole to close and communicate with the through hole A fluid passage corresponding to the hole is in communication with the outlet conduit or can be released or disengaged from the through hole to open communication between the fluid passage corresponding to the through hole and the outlet conduit.

In some embodiments, the channel switch member may include: a sealing film overlying the through hole of the channel communication member; a selection slider located above the sealing film and having a communication member with the channel a through-hole matching protrusion, wherein the selection slider is configured to be pressed against the sealing film to enable the protrusion to engage with the through hole to close a fluid passage corresponding to the through hole The communication of the outlet duct may be released or detached from the through hole to open communication of the fluid passage corresponding to the through hole with the outlet duct.

In some embodiments, the number of protrusions of the selection slider may be less than the number of fluid channels.

In some embodiments, the plurality of fluid channels can be configured such that the outlet is on a circumference of a circular surface of the single layer chip.

In some embodiments, the flow selecting mechanism may include: a selection disc covering the plurality of fluid passages on the single layer chip, having a circular shape with respective circumferences on one surface of the circular selection disc a plurality of through holes communicating with the outlets of the plurality of fluid passages, a sealing film covering the selection plate, a selection knob located above the sealing film, having a circular shape corresponding to the selection plate, a protrusion matching the through hole on a circumference of the circular selection knob, the outlet duct penetrating through the sealing film through the selection knob and in fluid communication with a through hole of the selection disc, wherein the selection knob Arranged to be rotatable to press the protrusion and the sealing film together into the pass The aperture is in fluid communication with the outlet conduit to close an outlet of the fluid passage corresponding to the through bore, wherein the number of the projections is less than the number of the flow passages.

In some embodiments, the selection knob can have a recess that receives the sealing film, the selection disk, and the chip.

In some embodiments, the plurality of fluid channels can be disposed on a multi-layer chip, for example, a fluid channel can be disposed on a layer of chips, and the fluid channels can be disposed on the chip in a variety of different manners.

In some embodiments, the multilayer chips can be laminated together and each layer of the chip is covered with a separator.

In some embodiments, the inlet conduit can extend through the multilayer chip and the diaphragm at one end of the stacked multilayer chip to communicate with an inlet of the plurality of fluid channels.

In some embodiments, the flow selecting mechanism may include: a hollow piercing member having a base end communicating with the outlet duct, an opening having a side wall at the front end; a selection slider, and the a base end of the hollow piercing member fixed to be slidable to selectively pierce a front end of the hollow piercing member for a septum on the multilayer chip to cause the opening to intersect the plurality of fluid passages A fluid passage is connected.

In some embodiments, the hollow piercing member can be formed integrally with the outlet conduit, for example, a hollow piercing member having an opening on a side wall of the front end can function as both an outlet conduit and a flow selection mechanism. portion.

In some embodiments, the opposite side of the chip on which the fluid passage is disposed may have a tapered bore that delivers fluid to the plurality of fluid passages in a state of passing through the flexible ball in the tapered bore .

In some embodiments, the flow of fluid in the plurality of fluid passages can be determined by one or more of a length, a cross-sectional shape, or a cross-sectional area of the fluid passage.

In some embodiments, the plurality of fluid channels can be formed on the chip by cutting or etching.

In some embodiments, the fluid can include insulin.

According to a second aspect of an embodiment of the present invention, there is provided a fluid infusion device for administering a patient with a flow regulating device, the device comprising: a housing (eg, the housing can be adapted to be worn The patient's skin is convenient for the patient to use, or can be worn on a belt, in a pocket, etc.); a reservoir, located in the housing for storing the infused fluid; a delivery assembly located in the housing And in fluid communication with the reservoir for transporting fluid in the reservoir to an injection assembly; an injection assembly located within the housing and in communication with the delivery assembly for outputting the delivery assembly Fluid is in fluid communication with the patient via an injection needle extending from the housing; wherein the delivery assembly includes the flow regulating device described above, the inlet conduit of the flow regulating device is in communication with the reservoir The outlet conduit is in communication with the injection assembly.

According to a third aspect of an embodiment of the present invention, there is provided a method for manufacturing a flow regulating device for use in a fluid infusion device for administering a patient, the method comprising: providing a fluid for delivery a plurality of fluid passages, wherein the plurality of fluid passages are configured to cause flow of fluid flowing through a portion of the plurality of fluid passages or all of the fluid passages to be different from one another; providing for transporting the fluid to the An inlet conduit for a plurality of fluid passages, wherein the inlet conduit is in communication with an inlet of the plurality of fluid passages; providing an outlet conduit for outputting fluid delivered in the plurality of fluid passages; A flow selection mechanism is disposed between the outlet of the fluid passage and the outlet conduit, wherein the flow selection mechanism is configured to select a portion of the plurality of fluid passages to communicate with the outlet conduit.

According to a fourth aspect of an embodiment of the present invention, there is provided a method for manufacturing a fluid infusion device for administering a patient with a flow regulating device, the method comprising: providing a housing for providing a reservoir for storing infused fluid, wherein the reservoir is located within the housing; providing an infusion set for delivery of fluid in the reservoir to an injection assembly, wherein the delivery assembly is located Inside the housing and in fluid communication with the reservoir; providing an injection assembly for fluidly outputting the delivery assembly to the patient via an injection needle extending from the housing, wherein An injection assembly is located within the housing; wherein the delivery assembly includes the flow conditioning device described above, an inlet conduit of the flow regulating device is in communication with the reservoir, and the outlet conduit is in communication with the injection assembly.

The above apparatus, apparatus and method provided by the embodiments of the present invention, by configuring the flow rates of the fluids in some or all of the plurality of fluid passages to be different from each other and selecting a part of the fluid passages to communicate with the outlet ducts by using the flow rate selecting mechanism, A variety of different flow options are available.

DRAWINGS

1 is a conceptual diagram of a flow regulating device according to an embodiment of the present invention;

2 is a schematic structural view of a flow rate adjusting device according to a first embodiment of the present invention;

Figure 3 is an exploded view of the flow regulating device shown in Figure 2;

4 is a schematic view of a fluid passage in accordance with an embodiment of the present invention;

5a to 5c are schematic views showing the sliding of a selection slider according to an embodiment of the present invention;

Figure 6a is a schematic structural view of a flow regulating device according to a second embodiment of the present invention;

Figure 6b is a cross-sectional view of the flow regulating device used in the fluid infusion device for administering a patient shown in Figure 6a along the A-A' diameter direction;

Figure 7 is an exploded view of the flow regulating device used in the fluid infusion device for administering a patient shown in Figure 6a;

Figure 8 is a schematic view showing the arrangement of a fluid passage according to a second embodiment of the present invention;

Figure 9a is a schematic structural view of a selection disc according to a second embodiment of the present invention;

Figure 9b is a cross-sectional view of the selection disk shown in Figure 9a along the diameter of B-B';

Figure 10 is a bottom plan view of a selection knob in accordance with a second embodiment of the present invention;

11 is a schematic structural view of a flow regulating device used in a fluid infusion device for administering a patient according to a third embodiment of the present invention;

Figure 12 is an exploded view of the flow regulating device used in the fluid infusion device for administering a patient shown in Figure 11;

Figure 13 is a cross-sectional view of the flow regulating device used in the fluid infusion device for administering a patient shown in Figure 11;

Figure 14 is a schematic view showing the arrangement of a fluid passage according to an embodiment of the present invention;

Figure 15 is a schematic view showing the arrangement of a fluid passage according to an embodiment of the present invention;

16 is a schematic illustration of a fluid infusion device for administering a patient with a flow regulating device in accordance with an embodiment of the present invention;

17 is a schematic illustration of a method for making a flow regulating device for use in a fluid infusion device for administering a patient, in accordance with an embodiment of the present invention;

18 is a schematic illustration of a method for making an infusion device for administering a patient with a flow regulating device, in accordance with an embodiment of the present invention.

detailed description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be further described in detail with reference to the accompanying drawings. It should be noted that the present invention is not limited to the components shown in the drawings. Various combinations of various embodiments of the invention may be made without departing from the spirit of the invention.

Referring to Figure 1, Figure 1 is a conceptual schematic diagram of a flow regulating device for use in a fluid infusion device for administering a patient in accordance with an embodiment of the present invention. The flow regulating device 1 may include a plurality of fluid passages 11, an inlet duct 12 (e.g., a hollow piercing member, etc.) in communication with the inlets of the plurality of fluid passages, and an outlet duct 13 that outputs fluid in the plurality of fluid passages. (for example, a hollow piercing member or the like) and a flow rate selecting mechanism 14 disposed between the outlet and outlet ducts 13 of the plurality of fluid passages 11. Wherein, the fluid may include a fluid medium such as insulin, an analgesic, the flow rate is the amount of fluid flowing through the cross section of the fluid passage per unit time, and the amount of fluid may be calculated in volume. In the case where the infusion fluid is insulin, the unit of flow rate can be unit/hour, wherein the conversion ratio of the unit/ml in the unit/hour is 100:1, that is, 1 ml is 100. Units. The plurality of fluid conduits 11 receive fluid delivered by the inlet conduit 12 at the inlet and fluid circulates in each fluid passage and are configured to cause flow rates of a portion of the fluid passages or all of the fluid passages of the plurality of fluid passages to differ from one another. For example, a plurality of (eg, greater than or equal to 2) fluid passages may be configured to have different flow rates, or a portion of the plurality of fluid passages (eg, 2, 3, 4 or more of them) Multiple) configurations are different from each other. A flow selection mechanism 14 is disposed between the outlet and outlet conduits 13 of the plurality of fluid passages 11, the inlet of which is in fluid communication with the outlet of the plurality of fluid passages 11, the outlet being in fluid communication with the outlet conduit 13, and configured to select a plurality of fluid passages A portion of the fluid passages (eg, one, two, three, or more fluid passages having different flow rates) are in fluid communication with the outlet conduit to achieve a variety of different flow options.

[First Embodiment]

2 is a schematic structural view of a flow regulating device used in a fluid infusion device for administering a patient according to a first embodiment of the present invention; and FIG. 3 is a view for administering a patient to the patient shown in FIG. An exploded view of the flow regulating device used in the fluid infusion device. The flow regulating device 100 may include a fluid passage 101, an inlet duct 102, an outlet duct 103, a passage communication member 104, a sealing film 105, and a selection button 106. Wherein, the plurality of fluid passages 101 are arranged in a parallel manner on the rectangular single-layer chip 107, having a groove-like structure embedded in the chip, and the upper cover is covered with the cover plate 108 to close the fluid passage 101 to the outside. For example, the chip 107 can be made of such high score as glass, resin or other. The material is made of a material such as a sub-material, and the fluid channel 201 can be formed on the chip 107 by cutting (for example, laser cutting) or etching. The plurality of fluid passages 101 may be arranged on the chip 107 in addition to the above-described parallel form, and may also be arranged in the form of a crucible. Embodiments of the invention do not define the arrangement of a plurality of fluid passages on a chip. The flow of fluid in each fluid passage 101 can be determined by one, two, or three of the length, cross-sectional area, or cross-sectional shape of the fluid passage. The inlet conduit 102 can be in fluid communication with a common inlet of the plurality of fluid passages 101 on the chip 107 through a through opening 1081 in the cover plate 108 at the inlet end of the fluid passage.

The passage communication member 104 is supported on the chip 107 and above the outlet of the fluid passage 101, for example, can be mounted on the cover plate 108 covering the fluid passage 101, and the cover 108 has a position and size with each outlet of the fluid passage 101. The matching through hole 1082, the passage communication member 104 communicates with the fluid passage 101 via the through hole 1082. The passage communication member 104 has a plurality of through holes 1041 that respectively communicate the outlet of the fluid passage 101 with the outlet duct 103, for example, the number of the through holes 1041 is equal to the number of the fluid passages 101. The through hole 1041 may select a cylindrical through hole having an equal diameter of the upper surface and the lower surface, and may also select a through hole having a bowl-shaped recess on the side contacting the sealing film 105. The shape is designed to be selected when the selection button closes the through hole. Further strengthen the sealing performance. The passage communication member 104 may further be provided with a recess 1042 communicating with the plurality of through holes 1041, and the outlet duct 103 may be inserted into the recess 1042 through the flexible block 109 (for example, a silica gel block) to be in fluid communication with the through hole 1041 on the passage communication member 104. .

The sealing film 105 (for example, a silicone film) covers the through hole 1041 of the passage communication member 104, and the closed seal can be enhanced when the selection button 106 closes the through hole 1041 of the passage communication member 104. A plurality of selection buttons 106 are disposed above the sealing film 105 and correspond to the number and position of the through holes 1041 of the channel communication member 104. Each of the plurality of selection buttons 106 may have a protrusion 1061 (eg, a bump) that matches the through hole 1041 of the channel communication member 104, for example, matching in size or shape. For example, the user and/or the patient may press a selection button 106 to press the convex portion 1031 of the button together with the sealing film 105 into the through hole 1041 of the channel communication member 104 corresponding to the convex portion, thereby closing the corresponding hole 1041. The fluid passage 101 is in fluid communication with the outlet conduit 103. For example, the user may also lift one of the plurality of selection buttons 106 to release the convex portion 1061 of the button from the corresponding through hole 1041 of the convex portion or to disengage the convex portion 1061 from the corresponding through hole 1041 of the convex portion. Thereby, the fluid passage 101 corresponding to the through hole 1041 is electrically connected to the outlet duct 103. In other words, use By selecting different press buttons, the user can obtain a variety of different flows, and the flow selection operation is simple and fast, and is convenient for the user to use in various scenes (for example, outdoor sports scenes, etc.).

In a case where the flow rate of the closed fluid passage is X and the total flow of the plurality of fluid passages on the chip is Y, the corresponding hole of the fluid passage on the passage communicating member is closed by pressing a button corresponding to the fluid passage on the selection button, The flow (YX) can be obtained at the outlet pipe. Since the flow rates of the plurality of fluid passages on the chip are different from each other, that is, the value of X is variable, different ones can be obtained by selecting different buttons (corresponding to closing different fluid passages) at the selection button. flow. In the case where a fluid passage is opened in communication with the outlet conduit by a selection button, the available flow rate is the flow rate of the open fluid passage.

For the case where the flow rates of a part of the fluid passages of the plurality of fluid passages are different from each other, and the flow rate of the remaining fluid passages is the same, the number of the through holes on the passage communicating member may be the same as the number of the partial fluid passages whose flow rates are different from each other, and the corresponding selection button may be The channels that are selected to be closed or open are those that have different flow rates from each other.

[Modification of First Embodiment]

In addition to selecting a sealing film to cooperate with a plurality of selection buttons to realize the switching of the through holes on the channel communication member, it is also possible to adopt a sealing film and a selection slider. For the embodiment of the sealing film and the selection slider, the sealing film covers the through hole of the passage communicating member, and the selection slider is located above the sealing film, has a convex portion matching the through hole on the passage communicating member, and can be configured The pressure is slid on the sealing film to press the convex portion and the sealing film together into the through hole on the passage communicating member, thereby closing the fluid passage of the corresponding fluid passage and the outlet duct, and may also be configured to guide the convex portion from the passage The through hole in the communicating member is released such that the corresponding fluid passage of the through hole communicates with the outlet duct.

The selection slider can have one or more protrusions (for example, bumps) on the surface of the contact sealing film, and the slider can be selected by the user and/or the patient by sliding the slider or the sliding rod, thereby making the slider The convex portion is pressed into the different through holes together with the sealing film, selectively closing the fluid passage of the corresponding fluid passage of the different through holes and the outlet pipe, or releasing or removing the convex portion from the through hole to open the corresponding corresponding to the through hole The fluid passage is in communication with the outlet conduit.

In the case where the projections are released from the through holes to open the communication, the selectable flow rate is the sum of the flow rates of the channels corresponding to the one or more through holes that are open. For the case where the convex portion is pressed into the through hole to close the communication, When the number of bumps on the slider is selected to be one, the available flow rate is selected as the sum of the flow rates of the plurality of fluid passages on the chip minus the flow rate of the one fluid passage selected to be closed. When the number of bumps on the selection slider is 2, the available flow rate is selected as the sum of the flow rates of the plurality of fluid channels on the chip minus the flow rate of the 2 fluid channels selected to be closed. When the slider of the slider is selected to be other quantities, and so on. Preferably, the number of protrusions on the selection slider is less than the number of fluid passages, for example, one less. In other embodiments, the number of protrusions on the selection slider is two less than the number of fluid passages, or three, and the like.

4 is a schematic illustration of a fluid passage in accordance with an embodiment of the present invention. 5a to 5c are schematic views of sliding of a selection slider according to an embodiment of the present invention. As shown in Fig. 4, taking the delivery of insulin as an example, the flow rates of the fluid flowing through the three

fluid passages

401, 402, and 403 are 40 units/day, 20 units/day, and 20 units/day, respectively. As shown in FIG. 5a to FIG. 5c, the sliders of the selection slider are two, one less than the number of fluid passages, and the selection slider is in the state shown in FIG. 5a, and the selection slider closes the

channels

401 and 402. The through hole on the passage communicating member, the passage 403 is in communication with the outlet duct, and the available flow rate is 20 units/day; the selection slider slides down in the direction shown in the figure to the state shown in Fig. 5b, and the selection slider is closed.

Channels

402 and 403 correspond to the through holes in the passage communication member, the passage 401 is in communication with the outlet duct, and the available flow rate is 40 units/day; the selection slider slides down in the direction shown in the figure to the state shown in Fig. 5c. The selection slider closes the through hole on the passage communicating member corresponding to the passage 403, and the

passages

401 and 402 communicate with the outlet duct, and the available flow rate is (40 + 20) units/day.

[Second Embodiment]

In the embodiment shown in Figures 2 and 3, the chip has a rectangular surface, a plurality of fluid channels are arranged linearly in parallel on the rectangular surface of the chip, and the chip can also have various shapes of surfaces (for example, circular, etc. And the fluid passages can also take a wide variety of arrangements (eg, hovering, radial radiating arrangements, etc.).

Figure 6a is a schematic view showing the structure of a flow regulating device used in a fluid infusion device for administering a patient according to a second embodiment of the present invention; and Figure 6b is a view for administering a patient as shown in Figure 6a. A cross-sectional view of the flow regulating device used in the fluid infusion device along the A-A' diameter direction; FIG. 7 is the flow regulating device used in the fluid infusion device for administering the patient shown in FIG. 6a. 8 is a schematic view showing the arrangement of a fluid passage according to a second embodiment of the present invention; Figure 9a is a schematic structural view of a selection disk according to a second embodiment of the present invention; Figure 9b is a cross-sectional view of the selection disk shown in Figure 9a along the diameter direction of B-B'; Figure 10 is a selection according to the second embodiment of the present invention The bottom view of the knob.

As shown in FIGS. 6-10, the flow regulating device 200 can include a fluid passage 201, an inlet conduit 202, an outlet conduit 203, a selection tray 204, a sealing membrane 205, and a selection knob 206. Figure 8 shows the arrangement of the fluid channels, the plurality of fluid channels 201 being concentrically arranged on the chip 207 having a circular surface with the center of the circular surface, the common inlet of the plurality of fluid channels 201 being arranged on the circular surface The center of the circle, the four outlets are respectively arranged on the circumference, spaced 90 degrees apart from each other. The flow of fluid within the passage can be defined based on the length of the fluid passage coil or the cross-sectional area of the passage. The fluid passages may be arranged on the chip in a manner other than that shown in FIG. 8, and other arrangements may be employed. For example, the common inlet of the fluid passages may be disposed at a position offset from the center of the circular surface, and the outlets are disposed on the circumference. The fluid passages are arranged in a curved shape along this position (for example, as shown in Fig. 14), or the fluid passages are arranged radially in the radial direction of the respective outlets (e.g., as shown in Fig. 15).

The opposite side of the chip 207 on which the fluid channel 201 is disposed (below the chip 207 as viewed in the direction shown in Figure 6b) may be provided with a tapered aperture 2071 through which the inlet conduit 202 (e.g., a hollow piercing member) may pass A ball 208 (e.g., a silicone ball) is captured in the tapered bore 2071 and inserted into the common inlet of the fluid passage 201 to deliver fluid to the plurality of fluid passages 201. The sealing property can be enhanced by the bonding of the flexible ball 208 and the tapered hole 2071.

The selection tray 204 has a circular shape corresponding to the circular chip 207, covering a plurality of fluid passages 201 of the circular chip 207. The circumference of the circular surface of the selection disk 204 has a plurality of through holes 2041 communicating with the outlets of the respective fluid passages 201 provided on the circumference of the circular chip 207. As shown in FIGS. 9a and 9b, the through hole 2041 may be a through hole having a bowl-shaped recess on the upper surface. In other embodiments, the through hole may be a cylindrical through hole having an equal diameter of the upper surface and the lower surface.

The selection disk 204 is covered with a sealing film 205 above which is a selection knob 206. The selection knob 206 has a circular surface corresponding to the selection disk 204 having a projection 2061 that matches the through hole 2041 of the selection disk 204 on the circumference, for example, position and size designed to block FIGS. 9a and 9b The bumps of the through holes are shown. The center of the circular surface of the selection knob 206 also has a through hole 2062 that allows the outlet conduit 203 (eg, a hollow piercing member) to enter and exit. The outlet conduit 203 can pass through the through hole 2062, through the sealing film 205, and on the selection tray 204. Through hole 2041 fluid connection through. For example, the outlet duct 203 can be inserted into the recess 2042 at the center of the selection disc 204 and in communication with each of the through holes 2041 on the circumference (for example, can be communicated by a groove or a pipe or the like), thereby making the outlet duct 203 and the selection tray 204 corresponds to the fluid passage of the through hole 2041.

The position of the convex portion 25 of the selection knob 206 corresponds to the position of the through hole 2041 on the selection disk 204 on the circumference and is sized to block the through hole 2041. The selection knob 206 is configured to be rotatable to drive the convex portion 2061 thereon to move circumferentially, and the one or more through holes 22 that are pressed into the selection disk 204 together with the sealing film 205 by the curvature selection convex portion 2061 rotated along the circumference. Thereby, the fluid communication of the outlet of the corresponding fluid passage of the through hole 2041 is closed. The number of the convex portions 2061 on the selection knob 206 (for example, the number of convex portions shown in FIG. 9 is 3) may be less than the number of fluid passages (for example, the number of fluid passages shown in FIG. 8 is 4). . In such a case, the flow rate corresponding to the fluid passage that the flow is connected to is obtained at the outlet pipe. By rotating the selection knob by a different arc, the corresponding through hole can be selected for the fluid channel that is intended to be closed, thereby achieving different flow options.

In the flow rate adjusting device 200 shown in FIG. 6b, the selection knob 206 has a recess 2063 capable of housing the sealing film 205, the selection disk 204, and the chip 207. The bottom surface of the recess 2063 is a circular surface corresponding to the size of the selection disk 204 and the chip 207, and a convex portion 2061 is provided on the circumference of the circular surface. The recess design of the selector knob 206 reduces the overall size of the flow regulating device, making the entire device more compact and also miniaturizing the device. However, in other embodiments, the selection knob can be designed to have no recess for receiving the sealing film, the selection disc or the chip, but a knob having a cylindrical shape directly mounted on the sealing film.

[Third embodiment]

As previously mentioned, the plurality of fluid channels can be disposed on a single layer of chip or on a multi-layer stacked chip. For example, a plurality of fluid channels may be respectively disposed on the multi-layer chip, and one fluid channel may be disposed on one chip, and the fluid channel on each chip may be one or two of a channel length, a cross-sectional area or a cross-sectional shape. Or three settings. Further, the fluid passage may be a groove formed by cutting or etching on the chip, or may be in the form of a pipe embedded in the chip. For channels in the form of grooves, the multilayer chips can be laminated together and each chip overlies a membrane (eg, a silicone membrane, etc.) to block fluid flow out of the channels. The inlet conduit may extend through the multilayer chip and the separator on the chip at one end of the stacked multilayer chip (for example, the end corresponding to the inlet conduit), thereby The inlets of the respective fluid passages are in communication.

Figure 11 is a schematic view showing the structure of a flow regulating device used in a fluid infusion device for administering a patient according to a third embodiment of the present invention; and Figure 12 is a view for administering the patient in Figure 11 An exploded view of the flow regulating device used in the fluid infusion device; FIG. 13 is a cross-sectional view of the flow regulating device used in the fluid infusion device for administering a patient shown in FIG. The flow regulating device 300 shown in Figure 11 can include a plurality of fluid passages 301 (illustrated as three), an inlet conduit 302 (e.g., a hollow piercing member), an outlet conduit 303, and a selection slider 304. Three fluid flows 301 are respectively disposed on the 3-layer chip 305, and the 3 layers of chips can form a chipset. The fluid channel 301 is a channel in the form of a groove on the chip 305. The chip 305 is also covered with a diaphragm 306. For example, it may be a silicone film or the like, and the fluid in the fluid channel 301 is blocked from flowing out through the chip 305. The inlet conduit 302 can extend fluid through the layers of the chip 305 and the membrane 306 thereon at the inlet end of the fluid channel 301 to deliver fluid to the fluid channel. For example, holes may be provided on the diaphragm 306 at positions corresponding to the inlets of the fluid passages 301 that are slightly larger than the inlet apertures of the fluid passages 301 through which fluid can flow freely into the fluid passages of the various layers. The uppermost diaphragm 306 of the chipset can also cover the cover plate 307. The cover plate 307 has a through hole 3071 on the outlet side of the fluid passage 301 of the chip set, and the outlet passage 303 can be inserted into the chip via the through hole 3071 on the cover plate 307. The groups are thus in fluid communication with the various fluid passages of the chip set.

The side wall of the front end of the outlet duct 303 (eg, a hollow piercing member) may have an opening, the selection slider 304 may be fixed to the base end of the outlet duct 303, and may be configured to be slidable to select the front end of the outlet duct 303 The membrane 306 on the multilayer chip is pierced such that the opening at the front end of the outlet conduit 303 communicates with one of the plurality of fluid passages. Due to the different flow rates of the fluid passages of the respective layers, the slide selection slider 304 controls the outlet duct 303 to pierce the stacked chip sets, so that the opening of the front end communicates with the fluid passages on one chip in the chip set, thereby obtaining the chip of the layer. The flow rate corresponding to the fluid channel. For example, in the embodiment shown in Figure 13, the outlet conduit 303 is inserted into the uppermost fluid channel of the chipset, and the flow rate corresponding to the fluid channel of the uppermost chip is obtained.

In the above embodiment, the selection slider is configured to cooperate with the outlet duct to achieve flow selection. In other embodiments, flow selection may also be achieved by selecting a slider and a separate hollow piercing member, in such an embodiment, the outlet conduit may not be designed in the form of a hollow piercing member. The base end of the hollow piercing member (eg, a hollow needle) can communicate with the outlet duct, the side wall of the front end The design has an opening. The front end of the hollow piercing member can be selectively pierced through the diaphragm of the multilayer chip on the outlet side of the fluid passage by sliding the selection slider fixed to the base end of the hollow piercing member, thereby opening the opening and the multilayer on the front end side wall The outlet of the fluid passage of one chip in the chip communicates to obtain a flow corresponding to the fluid passage.

Embodiments of the present invention also provide a fluid infusion device for administering a patient with a flow regulating device, the fluid infusion device can include a housing, for example, the housing can be adapted to be worn on a patient's skin so that Portable for use by a patient, or worn on a belt, in a pocket, etc.; a reservoir located within the housing and for storing infused fluid; a delivery assembly located within the housing and in fluid communication with the reservoir, A delivery assembly for delivering fluid in the reservoir to the injection assembly; an injection assembly located within the housing and in fluid communication with the delivery assembly for fluidly communicating fluid output by the delivery assembly to the patient via an injection needle extending from the housing . Wherein, the infusion set can include a flow regulating device having the various embodiments described above, wherein the inlet conduit of the flow regulating device can be in communication with the reservoir and the outlet conduit is in fluid communication with the injection assembly. 16 is a schematic illustration of a fluid infusion device for administering a patient with a flow regulating device in accordance with an embodiment of the present invention. The fluid infusion device 400 can include a housing 401, a select button 402 extending from an opening of the housing 401 (eg, can be a select button 106 in the flow regulating device 100). The housing 401 can accommodate the accumulator, the delivery assembly, the injection assembly, and the like. The surface of the housing 401 can have a transparent window 403, which can allow the user to view the storage condition of the fluid in the reservoir through the housing 401. The user knows in time the delivery status of the fluid in the reservoir; the delivery assembly can include a component for the base volume injection and an assembly for the pill dose injection, and accordingly, an injection button 404 that controls the pill injection can be placed in the housing 401 and A reset button 405; the injection assembly can include an injection needle that can be in fluid communication with the patient, the injection needle being controllable by an injection needle firing button 406 disposed in the housing 401. Additionally, the housing 401 can also be provided with an activation pin 407 for controlling activation of the fluid infusion device 400. The fluid infusion device provided by the embodiment of the invention has a flow selection function, and can select different flow rates quickly and conveniently by mechanical means such as selecting a button, selecting a slider or selecting a knob. In the case where the infusion fluid is insulin, it is convenient for the user and/or the patient to quickly select the insulin infusion flow according to different time periods of the day or different daily dining structures. Moreover, the above-described flow infusion device of the present invention can perform a plurality of flow rate selections only by a mechanical mechanism, and can significantly reduce the manufacturing cost of the infusion device as compared with an electronic infusion device requiring electric drive.

Embodiments of the present invention also provide a fluid for use in the manufacture of a medicament for administration to a patient A method of injecting a flow regulating device used in a device. 17 is a schematic diagram of a method for manufacturing a flow regulating device for use in a fluid infusion device for administering a patient, the method may include a step S101 of providing a fluid for delivery in accordance with an embodiment of the present invention. a plurality of fluid passages, wherein the fluid passages are configurable to cause flow rates of fluid flowing through a portion of the fluid passages or all of the fluid passages to be different from each other; and step S102, providing fluid for delivering the fluid to the plurality of fluid passages An inlet duct, wherein the inlet duct is in communication with an inlet of the plurality of fluid passages; and in step S103, an outlet duct for outputting fluid delivered in the plurality of fluid passages is provided; and in step S104, at the outlet and outlet ducts of the plurality of fluid passages A flow selection mechanism is provided therebetween, wherein the flow selection mechanism is configured to select a portion of the plurality of fluid passages to communicate with the outlet conduit.

Embodiments of the present invention also provide a method for manufacturing a fluid infusion device with a flow regulating device for administering a patient. 18 is a schematic diagram of a method for manufacturing a fluid infusion device for administering a patient with a flow regulating device according to an embodiment of the present invention. The method may include: step S201, providing a housing, step S202 Providing a reservoir for storing the infused fluid, wherein the reservoir is located within the housing; and in step S203, providing an infusion set for delivering fluid in the reservoir to the injection assembly, wherein the delivery assembly is located Inside the housing and in fluid communication with the reservoir; and in step S204, an injection assembly is provided for fluidly outputting the delivery assembly to the patient via an injection needle extending from the housing, wherein the injection assembly is located within the housing. Wherein the delivery assembly can include the flow regulating device of various embodiments described above, wherein the inlet conduit of the flow regulating device is in communication with the reservoir and the outlet conduit is in fluid communication with the injection assembly.

It should be noted that, although the various aspects of the above-described devices, devices, methods, and the like are described in a particular order and specific structural arrangement, this is for the purpose of illustration only and is not limiting of the invention, the claimed subject matter It is limited to the order and structural arrangement described. It will be appreciated by those skilled in the art that various modifications can be made in the invention and equivalents can be made without departing from the spirit of the invention. Therefore, the claimed subject matter is not limited to the specific embodiments disclosed above, and may include all technical solutions falling within the scope of the claims and equivalent technical solutions. Furthermore, in the claims, all terms are to be understood in the broadest

Claims

A flow regulating device for use in a fluid infusion device for administering a patient, comprising:

a plurality of fluid passages for conveying fluid, and configured to cause flow rates of fluid flowing through a portion of the plurality of fluid passages or all of the fluid passages to be different from each other;

An inlet conduit in communication with an inlet of the plurality of fluid passages for delivering fluid to the plurality of fluid passages;

An outlet conduit for outputting fluid delivered in the plurality of fluid passages;

A flow selection mechanism disposed between the outlet of the plurality of fluid passages and the outlet conduit and configured to select a portion of the plurality of fluid passages to communicate with the outlet conduit.
The device of claim 1 wherein said plurality of fluid channels are disposed on a single layer of chip.
The apparatus of claim 2 wherein said flow selection mechanism comprises:

a channel communication member on the single layer chip and above the outlet of the plurality of fluid channels, having a plurality of selection channels capable of respectively connecting the outlets of the plurality of fluid channels to the outlet conduit;

A channel switch component engages the channel communication component and is configured to selectively open or close the selection channel.
The apparatus according to claim 3, wherein said plurality of selection passages are a plurality of through holes disposed on said passage communication member.
The apparatus of claim 4 wherein said channel switch component comprises:

a sealing film covering a plurality of through holes of the passage communicating member;

a plurality of selection buttons corresponding to the plurality of through holes and located above the sealing film, each of the plurality of selection buttons having a protrusion matching a through hole on the channel communication member, and configured Engaging with the through hole to close a fluid passage corresponding to the through hole and the outlet pipe The communication may be released from the through hole to open communication between the fluid passage corresponding to the through hole and the outlet pipe.
The apparatus of claim 4 wherein said channel switch component comprises:

a sealing film covering the through hole of the passage communicating member;

Selecting a slider over the sealing film having a protrusion that mates with a through hole in the passage communication member, wherein the selection slider is configured to press against the sealing film to cause the protrusion The portion can be engaged with the through hole to close the communication of the fluid passage corresponding to the through hole with the outlet pipe or can be released from the through hole to open the fluid passage corresponding to the through hole and the outlet pipe Connectivity.
The apparatus of claim 6 wherein the number of projections of said selection slider is less than the number of said fluid passages.
The device of claim 2, the plurality of fluid channels configured to exit on a circumference of a circular surface of the single layer chip.
The apparatus of claim 8 wherein said flow selection mechanism comprises:

Selecting a disk covering the plurality of fluid passages on the single-layer chip, having a circular shape, having a plurality of passages respectively communicating with outlets of the plurality of fluid passages on a circumference of one surface of the circular selection disk hole,

a sealing film covering the selection tray,

a selection knob located above the sealing film, having a circular shape corresponding to the selection disk, having a protrusion on a circumference of the circular selection knob that matches a through hole in the selection disk, the outlet pipe Passing through the sealing membrane through the selection knob and in fluid communication with the through hole of the selection disc,

Wherein the selection knob is configured to be rotatable to press the protrusion and the sealing film together into the through hole to close fluid communication with the through hole and the outlet pipe, The number of protrusions is less than the number of fluid channels.
The device according to claim 9, wherein said selection knob has a housing The sealing film, the selection disk, and the recess of the chip.
The device of claim 1 wherein said plurality of fluid passages are respectively disposed on a multilayer chip.
The device according to claim 11, wherein said multilayer chips are laminated together and each layer of the chip is covered with a separator.
The device of claim 12 wherein said inlet conduit extends through said multilayer chip and said diaphragm at one end of said stacked multilayer chip to communicate with an inlet of said plurality of fluid passages.
The apparatus of claim 13 wherein said flow selection mechanism comprises:

a hollow piercing member, the base end of the hollow piercing member is in communication with the outlet duct, and the side wall of the front end has an opening;

Selecting a slider fixed to a base end of the hollow piercing member, configured to be slidable such that a front end of the hollow piercing member selectively pierces a septum on the multilayer chip to cause the opening One of the plurality of fluid passages is in communication.
The device of claim 14 wherein said hollow piercing member is formed integrally with said outlet conduit.
The apparatus according to any one of claims 8 to 10, wherein the opposite side of the chip on which the fluid passage is disposed has a tapered hole, the inlet duct being stuck in the taper through the flexible ball The state of the orifice delivers fluid to the plurality of fluid passages.
Apparatus according to any one of claims 1 to 15 wherein the flow of fluid in said plurality of fluid passages is determined by one or more of a length, a cross-sectional shape or a cross-sectional area of the fluid passage .
The apparatus according to any one of claims 2 to 15, wherein the plurality of fluid passages are formed on the chip by cutting or etching.
Apparatus according to any one of claims 1 to 15 wherein the fluid comprises insulin.
A fluid infusion device for administering a patient with a flow regulating device, comprising:

case;

a reservoir located in the housing for storing the infused fluid;

a delivery assembly located within the housing and in fluid communication with the reservoir for delivering fluid in the reservoir to an injection assembly;

An injection assembly, located within the housing and in communication with the delivery assembly, for fluidly communicating fluid output by the delivery assembly with the patient via an injection needle extending from the housing;

Wherein the delivery assembly comprises the flow regulating device of any one of claims 1 to 19, the inlet conduit of the flow regulating device is in communication with the reservoir, and the outlet conduit is in communication with the injection assembly.
A method for manufacturing a flow regulating device for use in a fluid infusion device for administering a patient, comprising:

Providing a plurality of fluid passages for conveying a fluid, wherein the plurality of fluid passages are configured to cause flows of fluid flowing through a portion of the plurality of fluid passages or all of the fluid passages to be different from each other;

Providing an inlet conduit for delivering fluid to the plurality of fluid passages, wherein the inlet conduit is in communication with an inlet of the plurality of fluid passages;

Providing an outlet conduit for outputting fluid delivered in the plurality of fluid passages;

A flow selection mechanism is disposed between the outlet of the plurality of fluid passages and the outlet conduit, wherein the flow selection mechanism is configured to select a portion of the plurality of fluid passages to communicate with the outlet conduit.
A method for manufacturing a fluid infusion device for administering a patient with a flow regulating device, comprising:

Providing a housing,

Providing a reservoir for storing an infused fluid, wherein the reservoir is located within the housing;

Providing an infusion set for delivery of fluid in the reservoir to an injection assembly, wherein the delivery assembly is located within the housing and in fluid communication with the reservoir;

Providing an injection assembly for fluidly outputting the delivery assembly to the patient via an injection needle extending from the housing, wherein the injection assembly is located within the housing;

Wherein the delivery assembly comprises the flow regulating device of any one of claims 1 to 19, the inlet conduit of the flow regulating device is in communication with the reservoir, and the outlet conduit is in communication with the injection assembly.