WO2021081858A1 - Temperature compensation flow-limiting device and elastomeric infusion system - Google Patents

Temperature compensation flow-limiting device and elastomeric infusion system Download PDF

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Publication number
WO2021081858A1
WO2021081858A1 PCT/CN2019/114543 CN2019114543W WO2021081858A1 WO 2021081858 A1 WO2021081858 A1 WO 2021081858A1 CN 2019114543 W CN2019114543 W CN 2019114543W WO 2021081858 A1 WO2021081858 A1 WO 2021081858A1
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temperature
inner layer
limiting device
layer
outer layer
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PCT/CN2019/114543
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French (fr)
Chinese (zh)
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丁原杰
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丁原杰
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps

Definitions

  • This application is related to an elastic infusion system, in particular to a temperature compensation current limiting device and an elastic infusion system.
  • the factors that cause the changes in the pressure and flow rate of the liquid medicine are still affected by the change in the temperature of the liquid medicine.
  • the environmental temperature of the infusion system at home is generally between 5 and 40 °C, because the temperature rises will produce Thermal expansion effect, the diameter of the infusion tube and the capillary element will increase, and the viscosity of the liquid medicine will decrease.
  • the combination of the two factors will increase the flow rate and flow rate of the liquid medicine in the infusion tube and the capillary element.
  • the temperature decreases the opposite trend is observed. Obviously It is impossible to overcome the influence of changes in flow rate caused by temperature changes.
  • the main purpose of this application is to provide a temperature-compensated flow limiting device and an elastic infusion system, which can improve the flow rate instability caused by temperature changes, and provide patients with a consistent and stable flow rate curve to ensure the use of safety.
  • the present application provides a temperature-compensated current-limiting device connected to an infusion tube of an elastic infusion system.
  • the temperature-compensated current-limiting device includes at least one inner layer and at least one coating on the outer side of the inner layer.
  • An outer layer, the thermal expansion coefficient of the inner layer is greater than the thermal expansion coefficient of the outer layer, when the temperature of the fluid in the infusion tube rises, the inner layer can expand and be restricted by the outer layer to reduce the inner diameter, and when the temperature drops, the inner The layer can shrink and be limited by the outer layer to enlarge the inner diameter.
  • the inner layer has a tubular shape, and a tubular inner cavity serving as an infusion channel is provided in the inner layer.
  • the inner diameter of the lumen of C o, the outer diameter of the inner layer is d o, when the outer layer, inner layer and the inner cavity of cross section other than a circular shape, the inner layer
  • the system has the circular diameter calculated by the guidance of the equal cross-sectional area as C o and d o , which can be called the equivalent diameter.
  • the inner cavity of the inner layer is eccentric.
  • C o d o and the ratio k is larger than 0.
  • k is greater than 0 and less than 0.24.
  • a pressure regulator is also included to adjust the fluid flow state output by the bladder dispenser.
  • Figure 1 is a schematic diagram of a known elastic infusion system.
  • Fig. 2 is a three-dimensional schematic diagram of the temperature compensation current limiting device of the present application.
  • FIG. 3 is a schematic diagram of the alignment and misalignment of the two ends of the inner layer and the outer layer in the temperature compensation current limiting device of the present application.
  • 4a to 4c are schematic diagrams of different cross-sections of the temperature-compensated current-limiting device of the present application.
  • Fig. 5 is a schematic diagram of adding additional layers to the inner and outer layers of the temperature-compensated current-limiting device of the present application.
  • Fig. 6 is a graph of the stability coefficient S-factor curve of a complex example of the simulated temperature compensation current limiting device adopting a single-layer structure.
  • Fig. 7 is a graph of the stability coefficient S-factor curve of a complex example of the simulated temperature compensation current limiting device adopting a double-layer structure.
  • Fig. 8 is a comparison diagram of the stability coefficient S-factor curve of the single-layer structure and the double-layer structure of the simulated temperature compensation current limiting device and the fluid viscosity ( ⁇ ) under various temperature gaps ( ⁇ T).
  • Fig. 9 is a graph of the thermal expansion coefficient of the outer layer versus the thermal expansion coefficient of the inner layer in the temperature-compensated current limiting device of the present application.
  • Fig. 10 is a graph of the thermal expansion coefficient of the outer layer versus the outer diameter of the inner layer in the temperature-compensated current limiting device of the present application.
  • Figure 11 is a graph of the thermal expansion coefficient of the outer layer versus the ratio of the inner and outer diameters of the inner layer in the temperature-compensated current limiting device of the present application.
  • FIG. 12 is a schematic diagram of the alignment and misalignment of the two ends of the inner layer and the outer layer in another temperature-compensated current limiting device of the present application.
  • Fig. 13 is a curve diagram of the flow rate versus temperature of the temperature compensation flow limiting device and the infusion system of the present application.
  • Fig. 14 is a graph of the stability coefficient of the temperature-compensated current limiting device and the infusion system versus temperature in this application.
  • the temperature compensation current limiting device 10 of a preferred embodiment of the present application is set in an elastic infusion system.
  • the elastic infusion system includes a housing and an infusion tube connected to the housing One end of the tube is capable of outputting liquid medicine.
  • a support member is arranged in the housing, and a capsule-shaped dispenser is made of elastic material. It is expandable and contractible and is arranged on the outside of the support member and is located in the housing for injection of liquid medicine. It can produce elastic contraction pressure to output the liquid medicine from the infusion tube.
  • a pressure regulator is used to adjust the fluid flow state of the bladder dispenser to obtain a stable and accurate liquid medicine flow rate (with or without it).
  • the temperature compensation The flow limiting device 10 is connected to the infusion tube; the aforementioned housings, infusion tubes, support members, and bladder-shaped distributors are all the same as the components of known infusion sets, and the housing, infusion tube, and support members will not be repeated here.
  • the temperature-compensated current limiting device 10 includes an inner layer 12 and an outer layer 14.
  • the two ends of the inner layer 12 can be aligned with the two ends of the outer layer 14, or the inner
  • the two ends of the layer 12 can also protrude from the two ends of the outer layer 14.
  • the inner layer 12 and the outer layer 14 are firmly bonded and are made by co-extrusion or injection molding to prevent separation during use.
  • the coefficient of thermal expansion (CTE) of the inner layer 12 is greater than that of the outer layer 14.
  • the inner layer 12 can expand but is restricted by the outer layer 14 to reduce the inner diameter.
  • the flow rate of the fluid transmitted through the inner layer 12 is stabilized. To be precise, when the temperature rises, the viscosity will decrease and cause the flow rate to increase, but the inner layer 12 will shrink and cause the flow rate to decrease.
  • the outer layer 14 of the temperature-compensated current limiting device 10 of the present application covers and encloses the inner layer 12, which is not limited to any shape, and the inner cavity of the inner layer 12 is not limited to any cross-sectional shape and number, or even eccentricity; of different cross-sectional shape, number, position of the inner lumen 12 of the eccentric, C o can be considered like a circular cross-sectional area of the lumen diameter.
  • C o can be considered like a circular cross-sectional area of the lumen diameter.
  • d o the like may be considered The diameter of the circular outer layer 14 of the cross-sectional area. At this time, the circular diameter calculated through the guidance of the equal cross-sectional area can be called the effective diameter.
  • the temperature compensation current limiting device 10 is not limited to a tubular structure with at least two layers, and can also be a flat structure with at least two layers. Its manufacturing method can not only be used for extrusion, injection, grouting and sealing, etc., but also by micro-electromechanical (The layered trench structure is fabricated by methods such as mems), lithography, chemical etching, and vapor deposition (deposition), as shown in FIG. 4c.
  • the temperature-compensated current limiting device 10 is not limited to a two-layer structure composed of an inner layer 12 and an outer layer 14. As shown in FIG. 5, the inner layer 12 and the outer layer 14 may be additionally provided. Several additional layers 121, 122, 141 are used to produce additional medical functions, such as low-protein absorbent materials, additional layers to prevent reaction with drugs or other uses, and each additional layer does not affect the inner layer 12 and the outer layer 14 Performance.
  • the inner layer 12 and the outer layer 14 can be composed of different or the same compound, polymer, ceramic, glass, metal and other materials.
  • the inner layer 12 and the outer layer 14 are made of different materials, for example, when When the inner layer 12 and the outer layer 14 are made of different materials, the inner layer 12 can be one of flexible plastics such as PVC or thermoplastic polyurethane (TPU), and the outer layer 14 can be ABS, transparent ABS (MABS) or reinforced polyurethane elastomer (Reinforced urethane elastomer) and other flexible plastics, and the coefficient of thermal expansion (CTE) of the inner layer 12 is 130-200ppm/°C, and the coefficient of thermal expansion (CTE) of the outer layer 14 is lower than 110ppm/°C, as shown in Table 1. Show.
  • the same material with different formula, molecular weight and/or filler content can be used, which can be PVC, thermoplastic polyurethane (TPU), thermoplastic polyamide (Thermoplastic polyamide), and thermoplastic polyamide.
  • TPU thermoplastic polyurethane
  • Thermoplastic polyamide thermoplastic polyamide
  • thermoplastic polyamide thermoplastic polyamide
  • thermoplastic polyamide thermoplastic polyamide
  • One of flexible plastics such as polyester (Thermoplastic polyester) or polyolefin polymer (Polyolefin polymer), as shown in Table 2.
  • the outer layer 14 is also added with a negative thermal expansion (NTE) material or/and a low coefficient of thermal expansion (CTE) material, which can be polymer, ceramic, glass, or alloy, etc.
  • NTE negative thermal expansion
  • CTE low coefficient of thermal expansion
  • the negative thermal expansion (NTE) material can be ⁇ -Lixia Stone ( ⁇ -eucryptite) zirconium tungstate (ZrW2O8), cadmium cyanide (Cd(CN)2 ⁇ xCCl4), Mn3Ga0.7Ge0.3N0.88C0.12, LaFe10.5Co1.0Si1.5, MnCo0.98Cr0.02Ge, 0.4PbTiO3-0.6BiFeO3, strontium copper iron oxide (SrCu3Fe4O12), bismuth lanthanum nickel oxide (Bi0.95La0.05NiO3), iron-based superconductor (Sm2.75C60), calcium ruthenium manganese oxide (Ca2Ru0.9Mn0.1
  • the low coefficient of thermal expansion (CTE) material can be silicon lithium aluminum glass (SiO2-Al2O3-Li2O), silicon lithium magnesium glass (SiO2-Al2O3-MgO), silicon lithium zinc glass (SiO2-Al2O3-ZnO), mullite ( 3Al2O3 ⁇ 2SiO2), silicon nitride (Si3N4), silicon, boron carbide (B4C), titanium diboride (TiB2) or calcium zirconium phosphorus oxide (Ca0.5Zr2P3O12), as shown in Table 4.
  • the temperature-compensated current limiting device 10 Since the inner layer 12 and the outer layer 14 use the same material, although the temperature-compensated current limiting device 10 has a two-layer structure from the viewpoint of thermal expansion, it is composed of a continuous matrix of the same material (main phase, low/negative) Coefficient of Thermal Expansion (CTE) material is the secondary phase), the interface between the two layers disappears and will not form an interface, like composite materials, low/negative coefficient of thermal expansion (CTE) materials are not limited to particles, whiskers, fibers, microspheres, In the form of flakes or rings.
  • CTE Coefficient of Thermal Expansion
  • the temperature compensation current limiting device 10 can be considered as a micro-scale transmission system, in which the pressure drop ⁇ P may affect the flow rate Q, which can be obtained from the Hagen-Poiseuille equation:
  • ⁇ P is the pressure gap between the proximal end and the distal end, and is considered constant by using a pressure regulator.
  • ⁇ is the viscosity of the fluid
  • Q is the volume flow rate of the fluid
  • R is the radius of the catheter.
  • ⁇ P is a constant.
  • the pressure regulator is the bladder distributor 5. Therefore, Q is determined by R, L, and ⁇ , which are all functions of temperature.
  • Formula (2) can be changed to:
  • Q(T) is inversely proportional to the viscosity ⁇ (T) and directly proportional to the third power of the length. If the temperature range is limited to 5 to 45°C, the maximum temperature difference ⁇ T is 40°C, and the thermal expansion coefficient of most capillary tubes is between 30 to 150ppm/°C. Multiply by ⁇ T and 40°C, the radius (length dimension) varies by 10-3.
  • the liquid medicine is mainly water, and its viscosity is 1cp at 20°C, and when the temperature becomes 5°C and 45°C, its viscosity is close to 1.52cp and 0.59cp, respectively. Observing the change between the radius and the viscosity at a temperature of 5°C to 45°C, it is obvious that the viscosity is the main factor that causes the flow rate change.
  • the thermal expansion coefficient of the outer layer 14 is E and the thickness is T
  • the thermal expansion coefficient of the inner layer 12 is e
  • the thickness is t
  • the diameter is d
  • the inner diameter is C.
  • the length of the temperature compensation current limiting device 10 is L and the outer diameter is C.
  • the diameter is D.
  • the length of the capillary L(T) is determined by the following formula:
  • the ratio of Q(T)/Q o can be used as a stability factor:
  • the viscosity of the water can be calculated as a function of temperature. Water follows the following relationship, and the temperature range is 5°C to 45°C.
  • the low coefficient of thermal expansion (CTE) layer (outer layer 14) is harder than the high coefficient of thermal expansion (CTE) layer (inner layer 12).
  • the thermal expansion behavior is a composite result determined by the coefficient of thermal expansion (CTE) of the two layers, and the flow rate of the capillary can be maintained from the influence of the environmental temperature change by manipulating E and e. Since E and e vary linearly with temperature and assuming that the value of e is much greater than the value of E, that is, e>E, the following model can be proposed:
  • D (T) is the temperature T is the diameter
  • D o is the diameter of the outer layer 14 at the initial temperature
  • E is the coefficient of thermal expansion of the outer layer 14
  • ⁇ T is the temperature difference between T and T O. Since the interfacial adhesion between the inner layer 12 and the outer layer 14 must be strong enough to prevent separation during storage and use of the product, it can be logically assumed that the outer layer 14 is harder and its thermal expansion is not affected by the inner layer.
  • the length of the capillary L(T) at temperature T is determined by the layer of higher stiffness.
  • the volume of the inner layer 12 ie layer d
  • the volume of the inner layer 12 is a function of temperature, which can be calculated by the following formula:
  • V d (T) V d o ⁇ (1+e ⁇ T) 3 (15)
  • V d (T)/V d o is taken (equal to the ratio of A d (T) ⁇ L(T)/A o ⁇ L o ), where V d o , Vd(T), A o and Ad( T) is the volume and cross-sectional area of the capillary d layer at T o and T. Therefore, the following formula can be obtained:
  • the coefficient of thermal expansion (CTE) of the outer layer 14 is smaller than the coefficient of thermal expansion (CTE) of the inner layer 12, that is, E ⁇ e, the volume flow deviation caused by the decrease in viscosity should pass through
  • the core diameter decreases as the temperature rises to compensate, and vice versa.
  • the following uses the stability coefficient S to evaluate that the temperature compensation current limiting device 10 (capillary tube) adopts a single-layer structure or a double-layer structure, and the effect of stabilizing the flow rate at different temperatures is better:
  • the simulation data shown in Table 6 can be generated.
  • the temperature compensation current limiting device 10 adopts a double-layer structure with a higher stability coefficient S than a single-layer structure. Close to 1.
  • the stability coefficient S is in the range of ⁇ 10% (within the temperature range of 5°C to 40°C). If Ex. 1 is compared with Ex. 2 to 12, it is obvious that the double-layered capillary tube shows a significant improvement in flow volume stability at various temperatures.
  • a double-layer core-shell structure with a soft inner layer 12 (higher coefficient of thermal expansion (CTE)) and a rigid outer layer 14 (lower coefficient of thermal expansion (CTE)) can be used in elastic infusion better flow generated in the system volume stability, as long as the presence of a suitable combination between E, e, C o, the parameter d o and ⁇ P.
  • the double-layer structure of the capillary shows a highly stable flow rate, and when the temperature changes from the initial state, the stability factor S can self-adjust.
  • the fluid viscosity ( ⁇ ) and S parameters of the single-layer structure and the double-layer structure are used to compare materials with positive thermal expansion coefficients under various temperature gaps ( ⁇ T).
  • ⁇ T temperature gaps
  • the S of the single-layer structure capillary has a linear relationship with the liquid viscosity ⁇ .
  • the double-layer structure capillary can make the stability coefficient S independent of the viscosity regardless of whether the temperature rises or falls.
  • the factor S of the double-layer structure capillary tube shows good self-alignment behavior under different ⁇ T, and it is always maintained in the safety zone of 0.9 to 1.1.
  • One of the reasons for this phenomenon is that the temperature increases The expansion of the raised soft inner layer 12 is limited by the rigid outer layer 14.
  • the expansion of the inner layer moves toward the inner cavity and reduces the diameter of the inner cavity, that is, C(T) becomes smaller than C o , as the temperature increases, when the viscosity ⁇ decreases, the flow rate increases by the diameter of the inner cavity
  • C(T) expands compensation the stability of volume flow can be realized.
  • the opposite process may occur, and the outer shrinkage of the inner layer can compensate for the higher viscosity and increase the diameter of the inner cavity.
  • the diameter of the inner cavity is mainly affected by the ambient temperature, following the heat/expansion rule and cold/shrinking positive thermal expansion coefficient material. In this case, the deviation of the flow rate is linearly proportional to ⁇ T, as shown in Figure 6, and it can easily exceed the safe range.
  • the above simulation results can prove that in order to produce a high degree of negative thermal expansion effect on the size of the capillary cavity, it can be realized by the characteristics of the material itself.
  • CTE coefficient of thermal expansion
  • the application achieves these effects through structural design.
  • the double-layer structure capillary composed of a soft inner layer and a rigid outer layer in this application can use the outer layer to constrain the thermal expansion of the inner layer to produce a highly negative thermal expansion effect on the size of the capillary cavity. , In turn, can resist the influence of temperature on fluid viscosity, which is a suitable application to solve the known problem of capillary flow stability.
  • the outer layer can be of any configuration, thickness or flex modulus, as long as the inner layer can be constrained and limited to obtain the aforementioned effects, it meets the requirements of the present application.
  • the coefficient of thermal expansion (CTE) of the soft inner layer and the coefficient of thermal expansion (CTE) of the rigid outer layer should follow the standards defined by the product requirements, for example, the flow rate stability coefficient S is in the following range: 1.1> S>0.9, or any variation range required by its application conditions, such as 1.05>S>0.95, or 1.15>S>0.85, the flow rate stability coefficient S is defined as formula (19).
  • the temperature compensation current limiting device can be designed as follows:
  • the Hagen-Poiseuille equation (ie formula 2) can be used to estimate the required lumen C o (the inner diameter of the inner layer 12).
  • the coefficient of thermal expansion (CTE) value of the inner layer and the outer diameter d o will determine the allowable thermal expansion coefficient of the outer layer material according to formulas (17) and (19) (CTE) range, so that the flow rate stability can be maintained within the required product requirements range (for example, 0.9 ⁇ S ⁇ 1.1), and then the outer layer material is formulated according to the determined outer layer material to allow the coefficient of thermal expansion (CTE) range, as shown in the figure 9 and Figure 10, the two curves in the figure respectively represent the difference between the maximum coefficient of thermal expansion (CTE-max) and the minimum coefficient of thermal expansion (CTE-min) inside and outside.
  • CTE coefficient of thermal expansion
  • the coefficient of thermal expansion shown by the CTE of outer layer on the ordinate is only for example. The actual situation is not limited to the example shown in the figure.
  • the Q of the capsule dispenser is 1ml/hr
  • the effective inner radius of the inner layer is calculated to be 0.072mm
  • the fluid viscosity ⁇ (20°C) 1cp
  • the coefficient of thermal expansion (CTE) of the inner layer is 150ppm/°C.
  • Figure 11 shows an example of the curve of the coefficient of thermal expansion (CTE) of the outer layer versus K (the ratio of the inner diameter to the outer diameter of the inner layer).
  • the ratio (k) of the inner cavity diameter to the outer diameter of the inner layer is greater than 0 and less than 0.3, and the preferable range of k value is It is greater than 0 and less than 0.24.
  • the inner layer 12 and the outer layer 14 of the temperature-compensated current limiting device 10 can be made by co-extrusion or injection molding as described above, and can also be potted with a rigid outer layer material (such as cement) using potting technology.
  • a rigid outer layer material such as cement
  • the temperature compensation current limiting device 20 can align the two ends of the inner and outer layers 22 and 24, or make the two ends of the inner layer 22 protrude from the outer layer 24 Two ends. If the temperature compensation flow limiting device 20 shown in FIG.
  • the flow rate of the flow device 30 changes its behavior as the temperature changes.
  • the outer layer 24 of the temperature compensation current limiting device 20 selects cement with a coefficient of thermal expansion (CTE) of about 85 ppm/° C. as the potting material, which covers about 50% of the total length of the inner layer 22.
  • the stability coefficient curve of the temperature compensation current limiting device 20 shown in Fig. 12 shows good compatibility with the curve predicted by the mathematical model, similar to the aforementioned Ex.12 and Ex.21, its stability coefficient S is within the safe range of 25°C to 43°C, which can fully prove that the flow rate of the elastic infusion system can be stabilized and minimized by using a temperature-compensated flow limiting device with a double-layer core-shell structure with a rigid outer layer Temperature/viscosity effect.
  • the present application provides a temperature-compensated flow limiting device and an elastic infusion system, which can improve the flow rate instability caused by temperature changes, and provide patients with a consistent and stable flow rate curve to ensure the safety of use.
  • the subject of this application can be manufactured and used in industry, and has industrial applicability.

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Abstract

Disclosed is a temperature compensation flow-limiting device (10) and an elastomeric infusion system. The temperature compensation flow-limiting device (10) is arranged in an infusion tube (2) of the elastomeric infusion system for overcoming instability in the flow rate of a fluid in the infusion tube (2) due to temperature change and maintaining a stable fluid flow rate, and includes an inner layer (12) and an outer layer (14), wherein the inner layer (12) has a coefficient of thermal expansion (CTE) greater than that of the outer layer (14), such that when the temperature of the fluid in the infusion tube (2) rises, the inner layer (12) expands and the inner diameter (Co) decreases due to the limiting of the outer layer (14), and when the temperature drops, the inner layer (12) can contract and the inner diameter (Co) increases due to the limiting of the outer layer (14).

Description

温度补偿限流装置与弹性输液***Temperature compensation current limiting device and elastic infusion system 技术领域Technical field
本申请与弹性输液***有关，特别是指一种温度补偿限流装置与弹性输液***。This application is related to an elastic infusion system, in particular to a temperature compensation current limiting device and an elastic infusion system.
背景技术Background technique
如今，已知的弹性输液***(EIS)(或称弹性输液泵***elastomeric infusion pump system、输液器)可施以压力输出药液，供在家的病患自行注射之用，其不需电力、费用不高、可处置与便携性均佳，使用上甚为方便，不过，弹性输液***须可靠且准确地运作，始可确保病患舒适和安全性。如图一的EIS***示意图所示，已知的弹性输液***的构成大体上包含一外壳1，便于病患舒适地贴身配戴，一输液管2，连接于外壳1一端，一支撑件3，设于外壳内，一囊状分配器4(bladder-type dispenser)，可膨胀、收缩地设于支撑件3而位于外壳1内，该囊状输液器4可为软囊或硬囊，可以由橡胶材料制成，亦可以加装弹簧或使用气压方式提供将药液输出的压力，并通过输液管2将药液输出，输液管2上并加装有一管状的毛细管元件5(或限流器、流量调节器)，多以玻璃或塑料等材质构成，一压力调节器6(或称流量限速器，pressure regulator)，设于输液管2以调节囊状分配器4输出的流体流动状态，获得稳定与准确的药液流速，相关专利如美国No.7892213B2、No.7341572、No.6619308、No.6273117、No.4769008、No.4904239、No.4318400等专利及No.20110106048A1、No.20110098673 A1等公开案所示”。Nowadays, the known elastic infusion system (EIS) (or elastic infusion pump system, infusion set) can apply pressure to output the liquid medicine for self-injection by patients at home without electricity or expense. It is not high, disposable and portable, and it is very convenient to use. However, the flexible infusion system must operate reliably and accurately to ensure patient comfort and safety. As shown in the schematic diagram of the EIS system in Figure 1, the known elastic infusion system generally includes a housing 1, which is convenient for the patient to wear next to the body comfortably, an infusion tube 2, connected to one end of the housing 1, and a support 3, Set in the housing, a bladder-type dispenser 4 (bladder-type dispenser) is swellable and contractible on the support 3 and located in the housing 1. The bladder-type infusion set 4 can be a soft or hard bladder. Made of rubber material, it can also be equipped with a spring or use air pressure to provide pressure to output the liquid medicine, and the liquid medicine is output through the infusion tube 2. A tubular capillary element 5 (or flow restrictor) is added to the infusion tube 2 , Flow regulator), mostly made of glass or plastic and other materials, a pressure regulator 6 (or pressure regulator) is set in the infusion tube 2 to adjust the fluid flow state of the bladder distributor 4, To obtain stable and accurate liquid flow rate, related patents such as US No. 7892213B2, No. 7341572, No. 6619308, No. 6273117, No. 4769008, No. 4904239, No. 4318400 and other patents and No. 20110106048A1, No. 20110098673 As shown in A1 and other public cases".
理想的弹性输液***的药液输出流速应维持一致性和准确性，输注过度或不足均不佳(目前对于弹性输液***的输注变化，在规定流量的±10％的范围是可接受的)，不过，当囊状分配器接近排空状态时，压力与流速会急剧地下降，使药液的流量不稳定，如图1所示，欲克服压力的变化，已知的方式加装一压力调节器，借以调节囊状分配器输出的流体流动状态，获得稳定与准确的药液流速。The output flow rate of the ideal elastic infusion system should maintain consistency and accuracy, and the infusion of over or under is not good (currently for the infusion of the elastic infusion system, the range of ±10% of the specified flow is acceptable ), but when the bladder dispenser is close to the empty state, the pressure and flow rate will drop sharply, making the flow of the liquid medicine unstable. As shown in Figure 1, to overcome the pressure change, a known method is installed. The pressure regulator adjusts the fluid flow state output by the capsule dispenser to obtain a stable and accurate flow rate of the liquid medicine.
其次，经分析，造成药液压力与流速的变化的因素，尚有药液温度变化造成的影响，输液***在家中的环境温度变化一般在5到40℃之间，由于温度升高时会产生热膨胀效应，输液管与毛细管元件的直径将增加，药液的粘度则会降低，两种因素的组合会增加输液管与毛细管元件中药液的流速、流量，温度降低时则呈相反趋势，显然无法克服温度改变造成流速变化的影响，而美国的No.7892213B2、No.4904239专利、No.20110106048A1、US20110098673 A1公开案将毛细管元件固定于病患的皮肤，利用病患的体热维持药液相对恒定的温度，而此乃以使用方式降低环境温度改变造成药液粘度变化的影响，申请人认为欲从根本解决此等问题，应改变毛细管元件的设计。Secondly, after analysis, the factors that cause the changes in the pressure and flow rate of the liquid medicine are still affected by the change in the temperature of the liquid medicine. The environmental temperature of the infusion system at home is generally between 5 and 40 ℃, because the temperature rises will produce Thermal expansion effect, the diameter of the infusion tube and the capillary element will increase, and the viscosity of the liquid medicine will decrease. The combination of the two factors will increase the flow rate and flow rate of the liquid medicine in the infusion tube and the capillary element. When the temperature decreases, the opposite trend is observed. Obviously It is impossible to overcome the influence of changes in flow rate caused by temperature changes. However, the US Patent Nos. 7892213B2, No. 4904239, No. 20110106048A1, and US20110098673 A1 publications fix the capillary element on the patient’s skin, and use the patient’s body heat to maintain the liquid relative to the patient’s skin. A constant temperature is used to reduce the influence of changes in the viscosity of the chemical liquid caused by changes in environmental temperature. The applicant believes that to fundamentally solve these problems, the design of the capillary element should be changed.
发明内容Summary of the invention
本申请的主要目的即在提供一种温度补偿限流装置与弹性输液***，其可改善由于温度变化引起 的流动速率不稳定性，并为病患提供一致和稳定的流速曲线，以保障使用的安全性。The main purpose of this application is to provide a temperature-compensated flow limiting device and an elastic infusion system, which can improve the flow rate instability caused by temperature changes, and provide patients with a consistent and stable flow rate curve to ensure the use of safety.
为达成前述的目的，本申请提供一种温度补偿限流装置，连接于一弹性输液***的一输液管，该温度补偿限流装置包含有至少一个内层与包覆于内层的外侧的至少一个外层，该内层的热膨胀系数大于外层的热膨胀系数，当该输液管内流体的温度上升时，该内层能够膨胀并受外层的限制而缩小内径，而当温度下降时，该内层能够收缩并受外层的限制而放大内径。In order to achieve the foregoing objective, the present application provides a temperature-compensated current-limiting device connected to an infusion tube of an elastic infusion system. The temperature-compensated current-limiting device includes at least one inner layer and at least one coating on the outer side of the inner layer. An outer layer, the thermal expansion coefficient of the inner layer is greater than the thermal expansion coefficient of the outer layer, when the temperature of the fluid in the infusion tube rises, the inner layer can expand and be restricted by the outer layer to reduce the inner diameter, and when the temperature drops, the inner The layer can shrink and be limited by the outer layer to enlarge the inner diameter.
可选地，该内层呈管状，其内设有作为输液通道的管状内腔。Optionally, the inner layer has a tubular shape, and a tubular inner cavity serving as an infusion channel is provided in the inner layer.
可选地，该内层的内腔直径为C o、该内层的外径为d o，当该外层、内层与内腔之横断面为圆形之外的形状时，该内层系具有以等截面积所导引计算出来的圆形直径作为C o与d o，可称之为等效直径。 Alternatively, the inner diameter of the lumen of C o, the outer diameter of the inner layer is d o, when the outer layer, inner layer and the inner cavity of cross section other than a circular shape, the inner layer The system has the circular diameter calculated by the guidance of the equal cross-sectional area as C o and d o , which can be called the equivalent diameter.
可选地，该内层的内腔为偏心。Optionally, the inner cavity of the inner layer is eccentric.
可选地，C o与d o的比值k大于0。 Alternatively, C o d o and the ratio k is larger than 0.
可选地，k小于0.3。Optionally, k is less than 0.3.
可选地，k大于0而小于0.24。Optionally, k is greater than 0 and less than 0.24.
可选地，该内层的内侧与外层的外侧还分别增设若干个附加层。Optionally, several additional layers are added to the inner side of the inner layer and the outer side of the outer layer, respectively.
本申请还提供一种弹性输液***，其包含有：一外壳；一输液管，连接于该外壳一端；一支撑件，设于该外壳内并对应输液管；一囊状分配器，能够膨胀、收缩地设于该支撑件的外侧而位于外壳内，能够产生弹性收缩的压力将药液自该输液管输出；一温度补偿限流装置，连接于该输液管，该温度补偿限流装置包含至少一个内层与包覆于内层外侧的至少一个外层，该内层的热膨胀系数大于外层的热膨胀系数，当该输液管内流体的温度上升时，该内层能够膨胀并受外层的限制而缩小内径。The present application also provides an elastic infusion system, which includes: a housing; an infusion tube connected to one end of the housing; a support member arranged in the housing and corresponding to the infusion tube; and a bladder-shaped dispenser capable of expanding, Shrinkingly arranged on the outside of the supporting member and located in the housing, the pressure capable of generating elastic contraction to output the medical solution from the infusion tube; a temperature compensation flow limiting device connected to the infusion tube, the temperature compensation flow limiting device includes at least An inner layer and at least one outer layer covering the outside of the inner layer. The coefficient of thermal expansion of the inner layer is greater than that of the outer layer. When the temperature of the fluid in the infusion tube rises, the inner layer can expand and is limited by the outer layer And shrink the inner diameter.
可选地，还包含有一压力调节器，以调节囊状分配器输出的流体流动状态。Optionally, a pressure regulator is also included to adjust the fluid flow state output by the bladder dispenser.
附图说明Description of the drawings
图1为一已知的弹性输液***的构成示意图。Figure 1 is a schematic diagram of a known elastic infusion system.
图2为本申请温度补偿限流装置的立体示意图。Fig. 2 is a three-dimensional schematic diagram of the temperature compensation current limiting device of the present application.
图3为本申请温度补偿限流装置中内层、外层的二端对齐与不对齐的示意图。FIG. 3 is a schematic diagram of the alignment and misalignment of the two ends of the inner layer and the outer layer in the temperature compensation current limiting device of the present application.
图4a至图4c为本申请温度补偿限流装置的不同断面示意图。4a to 4c are schematic diagrams of different cross-sections of the temperature-compensated current-limiting device of the present application.
图5为本申请温度补偿限流装置中内层、外层增设附加层的示意图。Fig. 5 is a schematic diagram of adding additional layers to the inner and outer layers of the temperature-compensated current-limiting device of the present application.
图6为模拟温度补偿限流装置采用单层结构的复数例子的稳定系数S因子曲线图。Fig. 6 is a graph of the stability coefficient S-factor curve of a complex example of the simulated temperature compensation current limiting device adopting a single-layer structure.
图7为模拟温度补偿限流装置采用双层结构的复数例子的稳定系数S因子曲线图。Fig. 7 is a graph of the stability coefficient S-factor curve of a complex example of the simulated temperature compensation current limiting device adopting a double-layer structure.
图8为模拟温度补偿限流装置采用单层结构与双层结构与流体粘度(μ)在各种温度间隙(ΔT)下的稳定系数S因子曲线比较图。Fig. 8 is a comparison diagram of the stability coefficient S-factor curve of the single-layer structure and the double-layer structure of the simulated temperature compensation current limiting device and the fluid viscosity (μ) under various temperature gaps (ΔT).
图9为本申请温度补偿限流装置中外层的热膨胀系数对内层的热膨胀系数的曲线图。Fig. 9 is a graph of the thermal expansion coefficient of the outer layer versus the thermal expansion coefficient of the inner layer in the temperature-compensated current limiting device of the present application.
图10为本申请温度补偿限流装置中外层的热膨胀系数对内层的外径的曲线图。Fig. 10 is a graph of the thermal expansion coefficient of the outer layer versus the outer diameter of the inner layer in the temperature-compensated current limiting device of the present application.
图11为本申请温度补偿限流装置中外层的热膨胀系数对内层的内、外径比的曲线图。Figure 11 is a graph of the thermal expansion coefficient of the outer layer versus the ratio of the inner and outer diameters of the inner layer in the temperature-compensated current limiting device of the present application.
图12为本申请另一温度补偿限流装置中内层、外层的二端对齐与不对齐的示意图。FIG. 12 is a schematic diagram of the alignment and misalignment of the two ends of the inner layer and the outer layer in another temperature-compensated current limiting device of the present application.
图13为本申请温度补偿限流装置与输液***的流速对温度的曲线图。Fig. 13 is a curve diagram of the flow rate versus temperature of the temperature compensation flow limiting device and the infusion system of the present application.
图14为本申请温度补偿限流装置与输液***的稳定系数对温度的曲线图。Fig. 14 is a graph of the stability coefficient of the temperature-compensated current limiting device and the infusion system versus temperature in this application.
具体实施方式Detailed ways
下面结合附图和具体实施例对本申请作进一步说明，以使本领域的技术人员可以更好的理解本申请并能予以实施，但所举实施例不作为对本申请的限定。The application will be further described below in conjunction with the drawings and specific embodiments, so that those skilled in the art can better understand and implement the application, but the examples cited are not intended to limit the application.
首先，请参阅图2与图3所示，本申请一较佳实施例的温度补偿限流装置10，设置于一弹性输液***，该弹性输液***包含有一外壳，一输液管，连接于该外壳的一端，可供输出药液，一支撑件，设于该外壳内，一囊状分配器，弹性材质构成，可膨胀、收缩地设于该支撑件外侧而位于外壳内，供注入药液，可产生弹性收缩的压力将药液自该输液管输出，一压力调节器，以调节囊状分配器输出的流体流动状态，获得稳定与准确的药液流速(有无均可)，该温度补偿限流装置10连接于输液管；前述各该外壳、输液管、支撑件与囊状分配器概与已知的输液器的组成元件相同，此处不予赘述各该外壳、输液管、支撑件与囊状分配器的详细构造与作动方式，该温度补偿限流装置10包含一内层12与一外层14，该内层12的二端可对齐外层14的二端，或者该内层12的二端亦可突出外层14的二端，该内层12、外层14之间牢固地粘合，通过共挤出管或注塑成型的方式制作，以防止在使用过程中分离，且该内层12的热膨胀系数(CTE)大于外层14。First, referring to Figures 2 and 3, the temperature compensation current limiting device 10 of a preferred embodiment of the present application is set in an elastic infusion system. The elastic infusion system includes a housing and an infusion tube connected to the housing One end of the tube is capable of outputting liquid medicine. A support member is arranged in the housing, and a capsule-shaped dispenser is made of elastic material. It is expandable and contractible and is arranged on the outside of the support member and is located in the housing for injection of liquid medicine. It can produce elastic contraction pressure to output the liquid medicine from the infusion tube. A pressure regulator is used to adjust the fluid flow state of the bladder dispenser to obtain a stable and accurate liquid medicine flow rate (with or without it). The temperature compensation The flow limiting device 10 is connected to the infusion tube; the aforementioned housings, infusion tubes, support members, and bladder-shaped distributors are all the same as the components of known infusion sets, and the housing, infusion tube, and support members will not be repeated here. In accordance with the detailed structure and operation of the capsule dispenser, the temperature-compensated current limiting device 10 includes an inner layer 12 and an outer layer 14. The two ends of the inner layer 12 can be aligned with the two ends of the outer layer 14, or the inner The two ends of the layer 12 can also protrude from the two ends of the outer layer 14. The inner layer 12 and the outer layer 14 are firmly bonded and are made by co-extrusion or injection molding to prevent separation during use. Moreover, the coefficient of thermal expansion (CTE) of the inner layer 12 is greater than that of the outer layer 14.
借此，当该输液管内流体的温度上升时，该内层12可膨胀但受到外层14的限制而缩小内径，借由该内层12直径的变化和流体粘度的变化之间的折衷，可稳定通过该内层12传输的流体流速。准确地说，当温度升高时，粘度会降低并引起流速的增加，但该内层12会收缩并导致流速下降，这两个过程将相互补偿并导致稳定的流量，反之亦然。Thereby, when the temperature of the fluid in the infusion tube rises, the inner layer 12 can expand but is restricted by the outer layer 14 to reduce the inner diameter. By the trade-off between the change in the diameter of the inner layer 12 and the change in fluid viscosity, The flow rate of the fluid transmitted through the inner layer 12 is stabilized. To be precise, when the temperature rises, the viscosity will decrease and cause the flow rate to increase, but the inner layer 12 will shrink and cause the flow rate to decrease. These two processes will compensate each other and lead to a stable flow rate, and vice versa.
其次，本申请该温度补偿限流装置10的外层14是包覆、封闭内层12，不限任何形状，该内层12的内腔亦不限任何断面形状与数量，甚或偏心；对于各种不同断面形状、数量、偏心位置的内层12的内腔，C o可视为等截面积的圆形内腔直径，同理，对于各种形状的外层14，d o可视为等截面积的圆形外层14的直径，此时，这种经由等截面积所导引计算出来的圆形直径，我们可以将其称之为等效内径(effective diameter)。对于各种不同断面形状、内腔数量、偏心位置的内外层结构，当此结构符合前述外刚内软的叙述时，均符合本申请所称的温度补偿限流装置。如图4a至图4c举例所示，其中图4a同心圆通道结构、偏心圆通道结构、接触外层孔型通道；图4b:多通道结构、多边形通道结构、接触外层角形通道；图4c:非圆形内层结构、方形内层沟槽通道、平层型沟槽结构。图中d o代表 该内层12的外径，C o为该内层12的内腔直径，亦即输送液体通道的直径。 Secondly, the outer layer 14 of the temperature-compensated current limiting device 10 of the present application covers and encloses the inner layer 12, which is not limited to any shape, and the inner cavity of the inner layer 12 is not limited to any cross-sectional shape and number, or even eccentricity; of different cross-sectional shape, number, position of the inner lumen 12 of the eccentric, C o can be considered like a circular cross-sectional area of the lumen diameter. Similarly, for the outer layer 14 of various shapes, d o the like may be considered The diameter of the circular outer layer 14 of the cross-sectional area. At this time, the circular diameter calculated through the guidance of the equal cross-sectional area can be called the effective diameter. For various inner and outer layer structures with different cross-sectional shapes, number of cavities, and eccentric positions, when this structure conforms to the foregoing description of outer rigid and inner soft, they all conform to the temperature compensation current limiting device referred to in this application. As shown in Figure 4a to Figure 4c for example, Figure 4a concentric circular channel structure, eccentric circular channel structure, contact outer hole-shaped channel; Figure 4b: multi-channel structure, polygonal channel structure, contact outer angular channel; Figure 4c: Non-circular inner layer structure, square inner layer groove channel, flat layer groove structure. In the figure, d o represents the outer diameter of the inner layer 12, and C o is the inner cavity diameter of the inner layer 12, that is, the diameter of the liquid conveying channel.
此外，该温度补偿限流装置10并不限于至少二层的管式构造，亦可以至少二层的扁平构造，其制造方式不仅可以挤出、射出、灌浆密封等传统工艺，亦可以微机电(mems)、光刻(lithography)、化学蚀刻(etching)、气相沈积(deposition)等方式制层状沟槽式结构，如图4c所示。In addition, the temperature compensation current limiting device 10 is not limited to a tubular structure with at least two layers, and can also be a flat structure with at least two layers. Its manufacturing method can not only be used for extrusion, injection, grouting and sealing, etc., but also by micro-electromechanical ( The layered trench structure is fabricated by methods such as mems), lithography, chemical etching, and vapor deposition (deposition), as shown in FIG. 4c.
此外，该温度补偿限流装置10并不限于由一内层12与一外层14所构成的双层结构，如图5所示，亦可该内层12的内侧与外层14的外侧增设若干附加层121、122、141，用以产生额外的医疗功能，例如低蛋白质吸收材料、防止与药物反应或其他用途的附加层，而各该附加层不会影响该内层12与外层14的性能。In addition, the temperature-compensated current limiting device 10 is not limited to a two-layer structure composed of an inner layer 12 and an outer layer 14. As shown in FIG. 5, the inner layer 12 and the outer layer 14 may be additionally provided. Several additional layers 121, 122, 141 are used to produce additional medical functions, such as low-protein absorbent materials, additional layers to prevent reaction with drugs or other uses, and each additional layer does not affect the inner layer 12 and the outer layer 14 Performance.
再者，该内层12、外层14可使用不同或相同的化合物、聚合物、陶瓷、玻璃、金属等材料的一构成，当该内层12、外层14使用不同材料时，例如，当该内层12、外层14使用不同材料时，该内层12可为PVC或热塑性聚氨酯(TPU)等柔性塑料之一，该外层14可为ABS、透明ABS(MABS)或增强聚氨酯弹性体(Reinforced urethane elastomer)等柔性塑料之一，且该内层12的热膨胀系数(CTE)是130-200ppm/℃，该外层14的热膨胀系数(CTE)是低于110ppm/℃，如表一所示。Furthermore, the inner layer 12 and the outer layer 14 can be composed of different or the same compound, polymer, ceramic, glass, metal and other materials. When the inner layer 12 and the outer layer 14 are made of different materials, for example, when When the inner layer 12 and the outer layer 14 are made of different materials, the inner layer 12 can be one of flexible plastics such as PVC or thermoplastic polyurethane (TPU), and the outer layer 14 can be ABS, transparent ABS (MABS) or reinforced polyurethane elastomer (Reinforced urethane elastomer) and other flexible plastics, and the coefficient of thermal expansion (CTE) of the inner layer 12 is 130-200ppm/℃, and the coefficient of thermal expansion (CTE) of the outer layer 14 is lower than 110ppm/℃, as shown in Table 1. Show.
表一：Table I:
Figure PCTCN2019114543-appb-000001
Figure PCTCN2019114543-appb-000001
Figure PCTCN2019114543-appb-000002
Figure PCTCN2019114543-appb-000002
而当该内层12、外层14使用相同材料时，可使用具有不同配方、分子量及/或填料含量的相同材料，可为PVC、热塑性聚氨酯(TPU)、热塑性聚酰胺(Thermoplastic polyamide)、热塑性聚酯(Thermoplastic polyester)或聚烯烃聚合物(Polyolefin polymer)等柔性塑料之一，如表二所示。When the inner layer 12 and the outer layer 14 use the same material, the same material with different formula, molecular weight and/or filler content can be used, which can be PVC, thermoplastic polyurethane (TPU), thermoplastic polyamide (Thermoplastic polyamide), and thermoplastic polyamide. One of flexible plastics such as polyester (Thermoplastic polyester) or polyolefin polymer (Polyolefin polymer), as shown in Table 2.
表二：Table II:
Figure PCTCN2019114543-appb-000003
Figure PCTCN2019114543-appb-000003
并使该外层14还添加有负热膨胀(NTE)材料或/及低热膨胀系数(CTE)材料，可为聚合物、陶瓷、玻璃或合金等，负热膨胀(NTE)材可为β-锂霞石(β-eucryptite)钨酸锆(ZrW2O8)、氰化镉(Cd(CN)2·xCCl4)、Mn3Ga0.7Ge0.3N0.88C0.12、LaFe10.5Co1.0Si1.5、MnCo0.98Cr0.02Ge、0.4PbTiO3-0.6BiFeO3、锶铜铁氧化物(SrCu3Fe4O12)、铋镧镍氧化物(Bi0.95La0.05NiO3)、铁基超导体(Sm2.75C60)、钙钌锰氧化物(Ca2Ru0.9Mn0.1O4)或AgI材料之一，如表三所示。And the outer layer 14 is also added with a negative thermal expansion (NTE) material or/and a low coefficient of thermal expansion (CTE) material, which can be polymer, ceramic, glass, or alloy, etc., and the negative thermal expansion (NTE) material can be β-Lixia Stone (β-eucryptite) zirconium tungstate (ZrW2O8), cadmium cyanide (Cd(CN)2·xCCl4), Mn3Ga0.7Ge0.3N0.88C0.12, LaFe10.5Co1.0Si1.5, MnCo0.98Cr0.02Ge, 0.4PbTiO3-0.6BiFeO3, strontium copper iron oxide (SrCu3Fe4O12), bismuth lanthanum nickel oxide (Bi0.95La0.05NiO3), iron-based superconductor (Sm2.75C60), calcium ruthenium manganese oxide (Ca2Ru0.9Mn0.1O4) or One of the AgI materials, as shown in Table 3.
表三：Table Three:
Figure PCTCN2019114543-appb-000004
Figure PCTCN2019114543-appb-000004
而低热膨胀系数(CTE)材料可为硅锂铝玻璃(SiO2-Al2O3-Li2O)、硅锂镁玻璃(SiO2-Al2O3-MgO)、硅锂锌玻璃(SiO2-Al2O3-ZnO)、莫莱石(3Al2O3·2SiO2)、氮化硅(Si3N4)、硅、碳化硼(B4C)、二硼化钛(TiB2)或钙锆磷氧化物(Ca0.5Zr2P3O12)之一，如表四所示。The low coefficient of thermal expansion (CTE) material can be silicon lithium aluminum glass (SiO2-Al2O3-Li2O), silicon lithium magnesium glass (SiO2-Al2O3-MgO), silicon lithium zinc glass (SiO2-Al2O3-ZnO), mullite ( 3Al2O3·2SiO2), silicon nitride (Si3N4), silicon, boron carbide (B4C), titanium diboride (TiB2) or calcium zirconium phosphorus oxide (Ca0.5Zr2P3O12), as shown in Table 4.
表四：Table Four:
Figure PCTCN2019114543-appb-000005
Figure PCTCN2019114543-appb-000005
由于该内层12、外层14使用相同的材料，虽然从热膨胀的观点来看，该温度补偿限流装置10双层结构，然而，其由相同材料的连续基质组成(主要相，低/负热膨胀系数(CTE)材料是次要相)，两层之间的界面消失、不会形成界面，如同复合材料，低/负热膨胀系数(CTE)材料不限于颗粒、晶须、纤维、微球、薄片或环等形式。Since the inner layer 12 and the outer layer 14 use the same material, although the temperature-compensated current limiting device 10 has a two-layer structure from the viewpoint of thermal expansion, it is composed of a continuous matrix of the same material (main phase, low/negative) Coefficient of Thermal Expansion (CTE) material is the secondary phase), the interface between the two layers disappears and will not form an interface, like composite materials, low/negative coefficient of thermal expansion (CTE) materials are not limited to particles, whiskers, fibers, microspheres, In the form of flakes or rings.
以下，兹说明本申请该温度补偿限流装置10的构成理论基础：Hereinafter, the theoretical basis of the composition of the temperature compensation current limiting device 10 of the present application will be explained:
该温度补偿限流装置10可被认为是微尺度传输***，其中压力下降ΔP可能影响流量Q，由哈根-卜瓦醉(Hagen-Poiseuille)方程式可得：The temperature compensation current limiting device 10 can be considered as a micro-scale transmission system, in which the pressure drop ΔP may affect the flow rate Q, which can be obtained from the Hagen-Poiseuille equation:
Figure PCTCN2019114543-appb-000006
Figure PCTCN2019114543-appb-000006
并可以重新排列为：And can be rearranged as:
Figure PCTCN2019114543-appb-000007
Figure PCTCN2019114543-appb-000007
其中，ΔP是近端和远端之间的压力间隙，且通过使用压力调节器被认为是常数。μ是流体的粘度，Q是流体的体积流速，R是导管的半径。ΔP是常数，此处压力调节器即囊状分配器5，因此，Q由R、L和μ确定、都是温度的函数。公式(2)又可改为：Among them, ΔP is the pressure gap between the proximal end and the distal end, and is considered constant by using a pressure regulator. μ is the viscosity of the fluid, Q is the volume flow rate of the fluid, and R is the radius of the catheter. ΔP is a constant. Here, the pressure regulator is the bladder distributor 5. Therefore, Q is determined by R, L, and μ, which are all functions of temperature. Formula (2) can be changed to:
Figure PCTCN2019114543-appb-000008
Figure PCTCN2019114543-appb-000008
通过简单的尺寸分析，Q(T)与粘度μ(T)成反比、与长度三次方成正比。若温度范围限制在5至45℃之间，则最大温差ΔT为40℃，多数毛细管的热膨胀系数在30至150ppm/℃之间，乘以ΔT、40℃，半径(长度尺寸)的变化范围为10-3。药液主要是水，其粘度在20℃时为1cp，当温度变为5℃和45℃时，其粘度分别接近1.52cp和0.59cp。观察在5℃到45℃的温度下半径和粘度之 间的变化，很明显粘度是导致流速变化的主要因素。Through a simple dimensional analysis, Q(T) is inversely proportional to the viscosity μ(T) and directly proportional to the third power of the length. If the temperature range is limited to 5 to 45°C, the maximum temperature difference ΔT is 40°C, and the thermal expansion coefficient of most capillary tubes is between 30 to 150ppm/°C. Multiply by ΔT and 40°C, the radius (length dimension) varies by 10-3. The liquid medicine is mainly water, and its viscosity is 1cp at 20°C, and when the temperature becomes 5°C and 45°C, its viscosity is close to 1.52cp and 0.59cp, respectively. Observing the change between the radius and the viscosity at a temperature of 5°C to 45°C, it is obvious that the viscosity is the main factor that causes the flow rate change.
假设该外层14的热膨胀系数为E、厚度为T，该内层12的热膨胀系数为e、厚度为t、直径为d、内径为C，该温度补偿限流装置10的长度为L、外径为D，当E等于e时，该温度补偿限流装置10变成单层结构，D＝d且E＝e，根据热膨胀的定义，以下等式始终有效：Assuming that the thermal expansion coefficient of the outer layer 14 is E and the thickness is T, the thermal expansion coefficient of the inner layer 12 is e, the thickness is t, the diameter is d, and the inner diameter is C. The length of the temperature compensation current limiting device 10 is L and the outer diameter is C. The diameter is D. When E is equal to e, the temperature compensation current limiting device 10 becomes a single-layer structure, D=d and E=e. According to the definition of thermal expansion, the following equation is always valid:
d(T)＝d o·(1+eΔT)       (4) d(T)=d o ·(1+eΔT) (4)
在温度T下，毛细管L(T)的长度由下式确定：At temperature T, the length of the capillary L(T) is determined by the following formula:
L(T)＝L o·(1+eΔT)       (5) L(T)=L o ·(1+eΔT) (5)
C(T)可自公式(6)获得：C(T) can be obtained from formula (6):
C(T)＝c o[1+e(ΔT)]        (6) C(T)=c o [1+e(ΔT)] (6)
回想公式(2)Recall formula (2)
Figure PCTCN2019114543-appb-000009
Figure PCTCN2019114543-appb-000009
当温度远离其初始状态时，新的体积流速转换为公式(7)，因为流量Q是温度的函数：When the temperature is far from its initial state, the new volumetric flow rate is converted to formula (7), because the flow rate Q is a function of temperature:
Figure PCTCN2019114543-appb-000010
Figure PCTCN2019114543-appb-000010
其中R＝0.5C，在此ΔP被视为常数。Where R=0.5C, where ΔP is regarded as a constant.
为了观察由于温度变化引起的体积流速的偏差，Q(T)/Q o的比率可作为稳定因子： In order to observe the deviation of the volume flow rate due to temperature changes, the ratio of Q(T)/Q o can be used as a stability factor:
Figure PCTCN2019114543-appb-000011
Figure PCTCN2019114543-appb-000011
若药液的含量主要是水，可以水的粘度作为温度的函数来计算。水遵循下述关系，温度范围为5℃至45℃。If the content of the liquid medicine is mainly water, the viscosity of the water can be calculated as a function of temperature. Water follows the following relationship, and the temperature range is 5°C to 45°C.
μ(T)＝1.022·μ o·e -0.024·ΔT          (9) μ(T)=1.022·μ o ·e -0.024·ΔT (9)
结合公式(8)和(9)，稳定系数S可重新定义如下：Combining formulas (8) and (9), the stability coefficient S can be redefined as follows:
Figure PCTCN2019114543-appb-000012
Figure PCTCN2019114543-appb-000012
公式(10)可简化为公式(11):Formula (10) can be simplified to formula (11):
Figure PCTCN2019114543-appb-000013
Figure PCTCN2019114543-appb-000013
当Q(T)等于Qo(即S＝1)时，成为稳定体积流量毛细管的理想条件。当Q(T)和Q o之间发生偏差时，若Q(T)/Q o的比值在±10％(即1.1≥S≥0.9)内，则输液***是可接受的。 When Q(T) is equal to Qo (ie S=1), it becomes an ideal condition for a stable volume flow capillary. When there is a deviation between Q(T) and Q o , if the ratio of Q(T)/Q o is within ±10% (ie 1.1≥S≥0.9), the infusion system is acceptable.
而当该温度补偿限流装置10如前述的双层结构毛细管时，低热膨胀系数(CTE)层(外层14)比高热膨胀系数(CTE)层(内层12)更硬。此时，热膨胀行为是由两层的热膨胀系数(CTE)确定的复合结果，可通过操纵E和e来保持毛细管的流速免受环境温度变化的影响。由于E和e随温度线性变化而且假设e的值远大于E的值，即e>E，可提出如下模型：When the temperature-compensated current limiting device 10 is the double-layer structure capillary tube described above, the low coefficient of thermal expansion (CTE) layer (outer layer 14) is harder than the high coefficient of thermal expansion (CTE) layer (inner layer 12). At this time, the thermal expansion behavior is a composite result determined by the coefficient of thermal expansion (CTE) of the two layers, and the flow rate of the capillary can be maintained from the influence of the environmental temperature change by manipulating E and e. Since E and e vary linearly with temperature and assuming that the value of e is much greater than the value of E, that is, e>E, the following model can be proposed:
D(T)＝D o·(1+EΔT)        (12) D(T)=D o ·(1+EΔT) (12)
其中，D(T)是温度为T时外层14的直径，D o是初始温度下的直径，E是该外层14的热膨胀系数，ΔT是T o和T的温差。由于该内层12、外层14之间的界面粘合必须足够强，才不会在产品储存和使用时分离，可符合逻辑地假设i该外层14更加地坚硬，其热膨胀不受该内层12的影响；(ii)该内层12的体积膨胀遵循外层14的约束，意味着，D(T)和L(T)将影响d(T)的值，d(T)跟随D层的线性膨胀；(iii)由于该内层12和外层14间的强粘附力，L(T)由D层确定。因而可创建以下关系： Wherein, D (T) is the temperature T is the diameter, D o is the diameter of the outer layer 14 at the initial temperature, E is the coefficient of thermal expansion of the outer layer 14, ΔT is the temperature difference between T and T O. Since the interfacial adhesion between the inner layer 12 and the outer layer 14 must be strong enough to prevent separation during storage and use of the product, it can be logically assumed that the outer layer 14 is harder and its thermal expansion is not affected by the inner layer. The influence of layer 12; (ii) The volume expansion of the inner layer 12 follows the constraints of the outer layer 14, which means that D(T) and L(T) will affect the value of d(T), and d(T) follows the D layer (Iii) Due to the strong adhesion between the inner layer 12 and the outer layer 14, L(T) is determined by the D layer. Therefore, the following relationships can be created:
d(T)＝d o[1+E(ΔT)]          (13) d(T)=d o [1+E(ΔT)] (13)
L(T)＝L o[1+E(ΔT)]           (14) L(T)=L o [1+E(ΔT)] (14)
因此，在温度T下毛细管L(T)的长度由较高刚度的层确定。当温度变化时，该内层12的体积(即d层)是温度的函数，可通过以下公式计算：Therefore, the length of the capillary L(T) at temperature T is determined by the layer of higher stiffness. When the temperature changes, the volume of the inner layer 12 (ie layer d) is a function of temperature, which can be calculated by the following formula:
V d(T)＝V d o·(1+eΔT) 3        (15) V d (T)=V d o ·(1+eΔT) 3 (15)
若取V d(T)/V d o的比率(等于A d(T)·L(T)/A o·L o的比率)，其中V d o、Vd(T)、A o和Ad(T)是T o和T处毛细管d层的体积和横截面积。因此，可得到以下公式： If the ratio of V d (T)/V d o is taken (equal to the ratio of A d (T)·L(T)/A o ·L o ), where V d o , Vd(T), A o and Ad( T) is the volume and cross-sectional area of the capillary d layer at T o and T. Therefore, the following formula can be obtained:
Figure PCTCN2019114543-appb-000014
Figure PCTCN2019114543-appb-000014
结合公式(13)、(14)and(16)，C(T)可以公式(17)求解：Combining formulas (13), (14) and (16), C(T) can be solved by formula (17):
Figure PCTCN2019114543-appb-000015
Figure PCTCN2019114543-appb-000015
回想公式(7):Recall formula (7):
Figure PCTCN2019114543-appb-000016
Figure PCTCN2019114543-appb-000016
以公式(17)取代公式(6)的C(T)，毛细管的稳定系数S可以公式(18)获得:Substituting formula (17) for C(T) in formula (6), the capillary stability coefficient S can be obtained by formula (18):
Figure PCTCN2019114543-appb-000017
Figure PCTCN2019114543-appb-000017
将公式(9)代入公式(18)，毛细管的稳定系数S可改写为公式(19):Substituting formula (9) into formula (18), the capillary stability coefficient S can be rewritten as formula (19):
Figure PCTCN2019114543-appb-000018
Figure PCTCN2019114543-appb-000018
对于该温度补偿限流装置10而言，若该外层14的热膨胀系数(CTE)小于内层12的热膨胀系数(CTE)，即E<e，则由于粘度降低引起的体积流量偏差应通过随温度升高而减小的芯径来补偿，反之亦然。For the temperature-compensated current limiting device 10, if the coefficient of thermal expansion (CTE) of the outer layer 14 is smaller than the coefficient of thermal expansion (CTE) of the inner layer 12, that is, E<e, the volume flow deviation caused by the decrease in viscosity should pass through The core diameter decreases as the temperature rises to compensate, and vice versa.
以下使用稳定系数S来评估该温度补偿限流装置10(毛细管)采用单层结构或双层结构，在不同温度下稳定流量的效果更好：The following uses the stability coefficient S to evaluate that the temperature compensation current limiting device 10 (capillary tube) adopts a single-layer structure or a double-layer structure, and the effect of stabilizing the flow rate at different temperatures is better:
首先，根据公式(11)，所有正热膨胀系数(PTE)的材料都表现得像如表五中Ex1的曲线。理论上，如果毛细管的热膨胀系数足够大，即可稳定流速，使得毛细管的体积变化能够补偿在各种温度变化下由粘度引起的流量变化。表五中可获得在S因子曲线0.9-1.1范围内的良好配合。EX 6和Ex7显示，当负热膨胀系数接近-7000ppm/℃和-8000ppm/℃之间范围时，流速看起来非常稳定，而在此范围的上、下，S因子曲线很快偏离安全区。First, according to formula (11), all materials with a positive thermal expansion coefficient (PTE) behave like the Ex1 curve in Table 5. In theory, if the thermal expansion coefficient of the capillary is large enough, the flow rate can be stabilized, so that the volume change of the capillary can compensate for the flow change caused by the viscosity under various temperature changes. In Table 5, a good fit within the range of 0.9-1.1 of the S-factor curve can be obtained. EX 6 and Ex7 show that when the negative thermal expansion coefficient is close to the range between -7000ppm/℃ and -8000ppm/℃, the flow rate looks very stable, and at the upper and lower parts of this range, the S-factor curve quickly deviates from the safe zone.
表五(稳定系数S，由公式(11)计算得出)：Table 5 (stability coefficient S, calculated by formula (11)):
Figure PCTCN2019114543-appb-000019
Figure PCTCN2019114543-appb-000019
表五(续)：Table 5 (continued):
Figure PCTCN2019114543-appb-000020
Figure PCTCN2019114543-appb-000020
再将表五中Ex1-10的S因子曲线画为图6。由图6可知，只要热膨胀系数(CTE)足够大，S-因子在0.9-1.1范围内的收敛就可以实现。不过，目前没有办法找到7000-8000ppm/℃的负热膨胀系数(CTE)材料，也就是说，在弹性输液***中使用单层结构的温度补偿限流装置来解决流量-体积的稳定性问题是非常困难的。Then draw the S-factor curve of Ex1-10 in Table 5 as Figure 6. It can be seen from Figure 6 that as long as the coefficient of thermal expansion (CTE) is large enough, the convergence of the S-factor in the range of 0.9-1.1 can be achieved. However, there is currently no way to find a material with a negative coefficient of thermal expansion (CTE) of 7000-8000ppm/℃. That is to say, it is very important to use a single-layer structure temperature compensation current limiting device in an elastic infusion system to solve the problem of flow-volume stability. difficult.
其次，基于公式(17)和(19)的计算，可产生表六所示的模拟数据，其中，该温度补偿限流装置10采用双层结构的稳定系数S比单层结构的稳定系数S更接近1。在Ex.12和Ex.21中，稳定系数S在±10％范围内(5℃至40℃的温度范围内)。如果将Ex.1与Ex.2至12进行比较，显然双层结构的毛细管在各种温度下显示出流动体积稳定性的显着改善。因此，可证明：只要有适当的组合，具有柔软内层12(较高热膨胀系数(CTE))和刚性外层14(较低热膨胀系数(CTE))的双层核-壳结构可以在弹性输液***中产生更好的流动体积稳定性，只要E、e、C o、d o与ΔP的参数之间存在适当的组合。 Secondly, based on the calculation of formulas (17) and (19), the simulation data shown in Table 6 can be generated. Among them, the temperature compensation current limiting device 10 adopts a double-layer structure with a higher stability coefficient S than a single-layer structure. Close to 1. In Ex.12 and Ex.21, the stability coefficient S is in the range of ±10% (within the temperature range of 5°C to 40°C). If Ex. 1 is compared with Ex. 2 to 12, it is obvious that the double-layered capillary tube shows a significant improvement in flow volume stability at various temperatures. Therefore, it can be proved that as long as there is an appropriate combination, a double-layer core-shell structure with a soft inner layer 12 (higher coefficient of thermal expansion (CTE)) and a rigid outer layer 14 (lower coefficient of thermal expansion (CTE)) can be used in elastic infusion better flow generated in the system volume stability, as long as the presence of a suitable combination between E, e, C o, the parameter d o and ΔP.
表六：Table 6:
Figure PCTCN2019114543-appb-000021
Figure PCTCN2019114543-appb-000021
表六(续)：Table 6 (continued):
Figure PCTCN2019114543-appb-000022
Figure PCTCN2019114543-appb-000022
再将表六中的数据绘制为图7，图中显示了在各种温度间隙下参数E、e、C o、d o与ΔP的各种组合的稳定性因子。虚线标记区域中的稳定性因子S表示毛细管的流量稳定，没有输注不足和过度输注 问题。若参照Ex1中的数据(单层毛细管)，其S大部分位于安全区之外，表现出非常差的流量稳定性。Ex.12和Ex.21的S因子都在虚线标记区域内，显然是该温度补偿限流装置10采用双层结构的良好实施例。 Sixth data table then plotted as in FIG. 7, there is shown a stability factor at the various combinations of the parameters E, e, C o, d o with a gap ΔP in various temperatures. The stability factor S in the dotted area indicates that the flow rate of the capillary is stable, and there is no problem of insufficient and over-infusion. If referring to the data in Ex1 (single-layer capillary), most of its S is outside the safe zone, showing very poor flow stability. The S factors of Ex.12 and Ex.21 are both in the area marked by the dotted line, which is obviously a good embodiment of the temperature-compensated current limiting device 10 adopting a double-layer structure.
由上可知，双层结构的毛细管显示出高度稳定的流速，且当温度从初始状态变化时，稳定性因子S能够自我调整。事实证明，如表7和图8所示，将单层结构和双层结构的流体粘度(μ)，S的参数用于使用正热膨胀系数材料在各种温度间隙(ΔT)下进行比较，当温度变化时，单层结构毛细管的S与液体粘度μ呈线性关系，相反地，双层结构的毛细管，无论温度是上升还是下降，均可以使稳定系数S与粘度无关。双层结构毛细管(Ex.12)的因子S在不同的ΔT下显示出良好的自对齐行为，并始终保持在0.9至1.1的安全区内，此等现象的原因之一，是随着温度的升高软质内层12的膨胀受到刚性外层14的限制。It can be seen from the above that the double-layer structure of the capillary shows a highly stable flow rate, and when the temperature changes from the initial state, the stability factor S can self-adjust. Facts have proved that, as shown in Table 7 and Figure 8, the fluid viscosity (μ) and S parameters of the single-layer structure and the double-layer structure are used to compare materials with positive thermal expansion coefficients under various temperature gaps (ΔT). When the temperature changes, the S of the single-layer structure capillary has a linear relationship with the liquid viscosity μ. On the contrary, the double-layer structure capillary can make the stability coefficient S independent of the viscosity regardless of whether the temperature rises or falls. The factor S of the double-layer structure capillary tube (Ex.12) shows good self-alignment behavior under different ΔT, and it is always maintained in the safety zone of 0.9 to 1.1. One of the reasons for this phenomenon is that the temperature increases The expansion of the raised soft inner layer 12 is limited by the rigid outer layer 14.
表七：Table 7:
Figure PCTCN2019114543-appb-000023
Figure PCTCN2019114543-appb-000023
因此，内层的膨胀向内腔移动并减小内腔的直径，即，C(T)变得小于C o，随着温度的升高，当粘度μ降低引起的流量增加由内腔的直径C(T)的膨胀补偿时，可实现体积流量的稳定性。随着温度降低，可能发生相反的过程，可通过该内层向外的收缩来补偿更高的粘度，并增加内腔的直径。对于图8(实施例1)中所示的常规单层毛细管，内腔的直径主要受环境温度的影响，遵循热/膨胀规则和冷/收缩正热膨胀系数材料。在这种情况下，流速的偏差与ΔT成线性比例，如图6所示，并且它很容易超出安全范围。 Therefore, the expansion of the inner layer moves toward the inner cavity and reduces the diameter of the inner cavity, that is, C(T) becomes smaller than C o , as the temperature increases, when the viscosity μ decreases, the flow rate increases by the diameter of the inner cavity When C(T) expands compensation, the stability of volume flow can be realized. As the temperature decreases, the opposite process may occur, and the outer shrinkage of the inner layer can compensate for the higher viscosity and increase the diameter of the inner cavity. For the conventional single-layer capillary shown in Fig. 8 (Example 1), the diameter of the inner cavity is mainly affected by the ambient temperature, following the heat/expansion rule and cold/shrinking positive thermal expansion coefficient material. In this case, the deviation of the flow rate is linearly proportional to ΔT, as shown in Figure 6, and it can easily exceed the safe range.
上述模拟结果可证明，为了产生在毛细管内腔尺寸上的高度负热膨胀效应，除了可以通过材料本身的特性来实现，例如采用高度负热膨胀系数(CTE)材料作为单层的毛细管，更可如本申请通过结构设计的方式达到此等效果，本申请由柔软内层和刚性外层组成的双层结构毛细管，可利用该外层约束内层的热膨胀，来产生毛细管内腔尺寸的高度负热膨胀效应，进而可抵抗温度对流体粘度的影响，是解决已知的毛细管流动稳定性问题的合适申请。而该外层可以是任何构型、厚度或弯曲模量(flex  modulus)，只要能够约束、限定该内层以获得前述效果，即符合本申请的所需。The above simulation results can prove that in order to produce a high degree of negative thermal expansion effect on the size of the capillary cavity, it can be realized by the characteristics of the material itself. For example, the use of a high degree of negative coefficient of thermal expansion (CTE) material as a single-layer capillary can be more effective. The application achieves these effects through structural design. The double-layer structure capillary composed of a soft inner layer and a rigid outer layer in this application can use the outer layer to constrain the thermal expansion of the inner layer to produce a highly negative thermal expansion effect on the size of the capillary cavity. , In turn, can resist the influence of temperature on fluid viscosity, which is a suitable application to solve the known problem of capillary flow stability. The outer layer can be of any configuration, thickness or flex modulus, as long as the inner layer can be constrained and limited to obtain the aforementioned effects, it meets the requirements of the present application.
再者，本申请该双层结构的温度补偿限流装置10前述材料的选择规则如下：Furthermore, the selection rules of the aforementioned materials for the temperature-compensated current limiting device 10 of the two-layer structure of the present application are as follows:
为了在双层毛细管中获得稳定的流速，软内层的热膨胀系数(CTE)和刚性外层的热膨胀系数(CTE)应遵循产品要求所定义的标准，例如流速稳定系数S在以下范围：1.1>S>0.9，或依其应用条件所需任何的变化范围，例如1.05>S>0.95,or 1.15>S>0.85，流速稳定系数S的定义如公式(19)。例如，如果弹性输液***需要8毫升/小时的流速，使用囊状分配器和压力调节器产生约5磅/平方英寸的恒定压力，使用长度约8公分的塑料温度补偿限流装置输送粘度接近0.9％盐溶液的药液，该温度补偿限流装置可以设计如下：In order to obtain a stable flow rate in the double-layer capillary, the coefficient of thermal expansion (CTE) of the soft inner layer and the coefficient of thermal expansion (CTE) of the rigid outer layer should follow the standards defined by the product requirements, for example, the flow rate stability coefficient S is in the following range: 1.1> S>0.9, or any variation range required by its application conditions, such as 1.05>S>0.95, or 1.15>S>0.85, the flow rate stability coefficient S is defined as formula (19). For example, if an elastic infusion system requires a flow rate of 8 ml/hour, use a bladder dispenser and pressure regulator to generate a constant pressure of about 5 psi, and use a plastic temperature compensation flow restriction device with a length of about 8 cm to deliver a viscosity close to 0.9 % Salt solution, the temperature compensation current limiting device can be designed as follows:
可先利用哈根-卜瓦醉(Hagen-Poiseuille)方程式(即公式2)预估所需的内腔C o(内层12内径)。 The Hagen-Poiseuille equation (ie formula 2) can be used to estimate the required lumen C o (the inner diameter of the inner layer 12).
c o＝f(Q,ΔP,L,μ)～0.072mm c o ＝f(Q,ΔP,L,μ)～0.072mm
接着选择该内层的材质与内层的外径d o，该内层的热膨胀系数(CTE)值及其外径d o将根据公式(17)、(19)确定外层材料允许的热膨胀系数(CTE)范围，使流速稳定性可保持在所需的产品要求范围内(例如0.9<S<1.1)，再根据确定的外层材料允许热膨胀系数(CTE)范围配制该外层材料，如图9与图10所示，图中的两个曲线分别表示内、外的最大热膨胀系数(CTE-max)与最小热膨胀系数(CTE-min)的差异值曲线，图9假设参数：ΔP＝5psi，L＝8cm，d o＝1mm，囊状分配器的Q为1ml/hr，该内层的有效半径计算为0.072mm，流体粘度μ(20℃)＝1cp，图9所示的数学模拟曲线中，纵座标的外层膨胀系数(CTE of outer layer)所展现的热膨胀系数数值仅为举例用途，实际情况不受限于图中所示之例，图10假设参数：ΔP＝5psi，L＝8cm，囊状分配器的Q为1ml/hr，该内层的有效内半径计算为0.072mm，流体粘度μ(20℃)＝1cp，内层的热膨胀系数(CTE)为150ppm/℃。图11则显示外层热膨胀系数(CTE)对K(内层的内径与外径之比)曲线的实例，当该内层的热膨胀系数(CTE)为(a)200ppm/℃，(b)175ppm/℃，(c)150ppm/℃和(d)125ppm/℃时，显示具有良好流速稳定性的参数。 Then select the material of the inner layer and the outer diameter d o of the inner layer, the coefficient of thermal expansion (CTE) value of the inner layer and the outer diameter d o will determine the allowable thermal expansion coefficient of the outer layer material according to formulas (17) and (19) (CTE) range, so that the flow rate stability can be maintained within the required product requirements range (for example, 0.9<S<1.1), and then the outer layer material is formulated according to the determined outer layer material to allow the coefficient of thermal expansion (CTE) range, as shown in the figure 9 and Figure 10, the two curves in the figure respectively represent the difference between the maximum coefficient of thermal expansion (CTE-max) and the minimum coefficient of thermal expansion (CTE-min) inside and outside. Figure 9 assumes the parameter: ΔP=5psi, L = 8cm, d o = 1mm , Q is a capsule dispenser 1ml / hr, the effective radius of the inner layer is calculated to be 0.072mm, fluid viscosity μ (20 ℃) = mathematical simulation curve shown 1cp, FIG. 9 , The coefficient of thermal expansion shown by the CTE of outer layer on the ordinate is only for example. The actual situation is not limited to the example shown in the figure. Figure 10 assumes the parameters: ΔP=5psi, L=8cm , The Q of the capsule dispenser is 1ml/hr, the effective inner radius of the inner layer is calculated to be 0.072mm, the fluid viscosity μ(20°C) = 1cp, and the coefficient of thermal expansion (CTE) of the inner layer is 150ppm/°C. Figure 11 shows an example of the curve of the coefficient of thermal expansion (CTE) of the outer layer versus K (the ratio of the inner diameter to the outer diameter of the inner layer). When the coefficient of thermal expansion (CTE) of the inner layer is (a) 200ppm/℃, (b) 175ppm /°C, (c) 150ppm/°C and (d) 125ppm/°C, showing good flow rate stability parameters.
且，由图11可知，当该内、外层的热膨胀系数差异够大时，该内层的内腔直径与内层外径的比值(k)大于0、小于0.3，较佳的k值范围是大于0而小于0.24。Moreover, it can be seen from Figure 11 that when the thermal expansion coefficient difference between the inner and outer layers is large enough, the ratio (k) of the inner cavity diameter to the outer diameter of the inner layer is greater than 0 and less than 0.3, and the preferable range of k value is It is greater than 0 and less than 0.24.
此外，该温度补偿限流装置10的内层12、外层14除了前述可通过共挤出管或注塑成型的方式制作，亦可利用灌封技术，将刚性外层材料(如水泥)灌封、包覆于内层外侧，如图12所示的温度补偿限流装置20，可使其内、外层22、24的二端对齐，或使该内层22的二端突出外层24的二端。若利用图12所示的温度补偿限流装置20进行弹性输液***的测试，该内管22的长度设为18cm、直 径设为0.2mm、外径设为2.5mm，囊状分配器的压力为4psi，体积流速为4毫升/小时，所得的流速曲线如图13所示，图中的虚线曲线遵循输液***的流速与温度间的线性关系，实线曲线则显示图12所示的温度补偿限流装置30的流速随温度变化而改变其行为。该温度补偿限流装置20的外层24选择热膨胀系数(CTE)约85ppm/℃水泥作为灌封材料，其约包覆该内层22的总长度50％。如图14所示，图12所示的温度补偿限流装置20的稳定系数曲线显示出与数学模型预测的曲线有良好的相容性，类似前述的Ex.12和Ex.21，其稳定系数S均在25℃至43℃的安全范围内，由此可充分证明通过使用具有刚性外层的双层核-壳结构的温度补偿限流装置，可以使弹性输液***的流速稳定并可最小化温度/粘度效应。In addition, the inner layer 12 and the outer layer 14 of the temperature-compensated current limiting device 10 can be made by co-extrusion or injection molding as described above, and can also be potted with a rigid outer layer material (such as cement) using potting technology. , Coated on the outside of the inner layer, as shown in FIG. 12, the temperature compensation current limiting device 20 can align the two ends of the inner and outer layers 22 and 24, or make the two ends of the inner layer 22 protrude from the outer layer 24 Two ends. If the temperature compensation flow limiting device 20 shown in FIG. 12 is used to test the elastic infusion system, the length of the inner tube 22 is set to 18 cm, the diameter is set to 0.2 mm, the outer diameter is set to 2.5 mm, and the pressure of the bladder distributor is 4psi, the volumetric flow rate is 4ml/hour, the resulting flow rate curve is shown in Figure 13. The dotted curve in the figure follows the linear relationship between the flow rate and temperature of the infusion system, and the solid curve shows the temperature compensation limit shown in Figure 12. The flow rate of the flow device 30 changes its behavior as the temperature changes. The outer layer 24 of the temperature compensation current limiting device 20 selects cement with a coefficient of thermal expansion (CTE) of about 85 ppm/° C. as the potting material, which covers about 50% of the total length of the inner layer 22. As shown in Fig. 14, the stability coefficient curve of the temperature compensation current limiting device 20 shown in Fig. 12 shows good compatibility with the curve predicted by the mathematical model, similar to the aforementioned Ex.12 and Ex.21, its stability coefficient S is within the safe range of 25°C to 43°C, which can fully prove that the flow rate of the elastic infusion system can be stabilized and minimized by using a temperature-compensated flow limiting device with a double-layer core-shell structure with a rigid outer layer Temperature/viscosity effect.
以上所述实施例仅是为充分说明本申请而所举的较佳的实施例，本申请的保护范围不限于此。本技术领域的技术人员在本申请基础上所作的等同替代或变换，均在本申请的保护范围之内。本申请的保护范围以权利要求书为准。The above-mentioned embodiments are only preferred embodiments for fully explaining the present application, and the protection scope of the present application is not limited thereto. The equivalent substitutions or transformations made by those skilled in the art on the basis of this application are all within the protection scope of this application. The scope of protection of this application is subject to the claims.
工业实用性Industrial applicability
本申请提供一种温度补偿限流装置与弹性输液***，其可改善由于温度变化引起的流动速率不稳定性，并为病患提供一致和稳定的流速曲线，以保障使用的安全性。且本申请的主题可以在工业中制造和使用，具备工业实用性。The present application provides a temperature-compensated flow limiting device and an elastic infusion system, which can improve the flow rate instability caused by temperature changes, and provide patients with a consistent and stable flow rate curve to ensure the safety of use. And the subject of this application can be manufactured and used in industry, and has industrial applicability.

Claims (10)

  1. 一种温度补偿限流装置，连接于一弹性输液***的一输液管，其特征在于，该温度补偿限流装置包含有至少一个内层与包覆于内层的外侧的至少一个外层，该内层的热膨胀系数大于外层的热膨胀系数，当该输液管内流体的温度上升时，该内层能够膨胀并受外层的限制而缩小内径，而当温度下降时，该内层能够收缩并受外层的限制而放大内径。A temperature-compensated current-limiting device connected to an infusion tube of an elastic infusion system, characterized in that the temperature-compensated current-limiting device includes at least one inner layer and at least one outer layer covering the outer side of the inner layer, the The thermal expansion coefficient of the inner layer is greater than the thermal expansion coefficient of the outer layer. When the temperature of the fluid in the infusion tube rises, the inner layer can expand and be restricted by the outer layer to reduce the inner diameter. When the temperature drops, the inner layer can shrink and be affected. The limit of the outer layer enlarges the inner diameter.
  2. 如权利要求1所述的温度补偿限流装置，其特征在于，该内层呈管状，其内设有作为输液通道的管状内腔。The temperature compensation flow limiting device according to claim 1, wherein the inner layer has a tubular shape, and a tubular inner cavity serving as an infusion channel is provided in the inner layer.
  3. 如权利要求2所述的温度补偿限流装置，其特征在于，该内层的内腔直径或等效直径为C o、该内层的外径或等效外径为d o。 2, temperature compensation of the current limiting device as claimed in claim, characterized in that the inner diameter of the lumen or equivalent diameter of C o, equivalent to the outer diameter of the inner layer or an outer diameter of d o.
  4. 如权利要求3所述的温度补偿限流装置，其特征在于，该内层的内腔为偏心。3. The temperature-compensated current limiting device of claim 3, wherein the inner cavity of the inner layer is eccentric.
  5. 如权利要求3所述的温度补偿限流装置，其特征在于，C o与d o的比值k大于0。 Temperature compensation of the current limiting device as claimed in claim 3, wherein, C o d o and the ratio k is larger than 0.
  6. 如权利要求5所述的温度补偿限流装置，其特征在于，k小于0.3。The temperature compensation current limiting device according to claim 5, wherein k is less than 0.3.
  7. 如权利要求6所述的温度补偿限流装置，其特征在于，k大于0而小于0.24。7. The temperature-compensated current limiting device of claim 6, wherein k is greater than 0 and less than 0.24.
  8. 如权利要求1所述的温度补偿限流装置，其特征在于，该内层的内侧与外层的外侧还分别增设若干个附加层。The temperature compensation current limiting device of claim 1, wherein a plurality of additional layers are added to the inner side of the inner layer and the outer side of the outer layer, respectively.
  9. 一种弹性输液***，其特征在于，包含有：An elastic infusion system, characterized in that it contains:
    一外壳；A shell
    一输液管，连接于该外壳一端；An infusion tube connected to one end of the shell;
    一支撑件，设于该外壳内并对应输液管；A supporting member, arranged in the housing and corresponding to the infusion tube;
    一囊状分配器，能够膨胀、收缩地设于该支撑件的外侧而位于外壳内，能够产生弹性收缩的压力将药液自该输液管输出；A bladder-shaped dispenser, which can be expanded and contracted on the outside of the support and located in the housing, and can generate elastic contraction pressure to output the liquid medicine from the infusion tube;
    一温度补偿限流装置，连接于该输液管，该温度补偿限流装置包含至少一个内层与包覆于内层外侧的至少一个外层，该内层的热膨胀系数大于外层的热膨胀系数，当该输液管内流体的温度上升时，该内层能够膨胀并受外层的限制而缩小内径。A temperature-compensated current-limiting device connected to the infusion tube, the temperature-compensated current-limiting device comprising at least one inner layer and at least one outer layer covering the outer side of the inner layer, the inner layer having a thermal expansion coefficient greater than that of the outer layer, When the temperature of the fluid in the infusion tube rises, the inner layer can expand and be restricted by the outer layer to reduce the inner diameter.
  10. 如权利要求9所述的弹性输液***，其特征在于，还包含有一压力调节器，以调节囊状分配器输出的流体流动状态。9. The elastic infusion system of claim 9, further comprising a pressure regulator to adjust the fluid flow state of the bladder dispenser.
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