TW201440824A - Pressure detector, blood circuit and blood purification apparatus with pressure detector - Google Patents

Pressure detector, blood circuit and blood purification apparatus with pressure detector Download PDF

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Publication number
TW201440824A
TW201440824A TW103104665A TW103104665A TW201440824A TW 201440824 A TW201440824 A TW 201440824A TW 103104665 A TW103104665 A TW 103104665A TW 103104665 A TW103104665 A TW 103104665A TW 201440824 A TW201440824 A TW 201440824A
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Taiwan
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liquid
blood
pressure
chamber
extracorporeal
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TW103104665A
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Chinese (zh)
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Shinya Takeuchi
Hiroshi Matsumoto
Mikiko Ikeda
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Toray Industries
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Publication of TW201440824A publication Critical patent/TW201440824A/en

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01LMEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L19/00Details of, or accessories for, apparatus for measuring steady or quasi-steady pressure of a fluent medium insofar as such details or accessories are not special to particular types of pressure gauges
    • G01L19/0007Fluidic connecting means
    • G01L19/0023Fluidic connecting means for flowthrough systems having a flexible pressure transmitting element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3639Blood pressure control, pressure transducers specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3639Blood pressure control, pressure transducers specially adapted therefor
    • A61M1/3641Pressure isolators

Abstract

The purpose of the present invention is to provide: a pressure-sensing element with a novel structure, said pressure-sensing element measuring the pressure inside an extracorporeal circulation circuit without coming into contact with blood or air, wherein coagulation of blood is better suppressed by minimizing the retention of blood as a result of improving the flow of blood inside the pressure-sensing element; and a blood circuit and a blood purification apparatus provided with the pressure-sensing element. The present invention provides a pressure-sensing element for an extracorporeal circulation circuit for measuring pressure inside an extracorporeal circulation circuit that performs extracorporeal treatment of blood, and is provided with: a chamber member provided with a fluid chamber that has a deforming surface deformed by the pressure inside the extracorporeal circulation circuit, a fluid inlet, and a fluid outlet, and that allows the blood to flow in and out; a fluid inlet joint for linking the fluid inlet to the extracorporeal circulation circuit; and a fluid outlet joint for linking the fluid outlet to the extracorporeal circulation circuit. Flow passages inside the fluid inlet joint and the fluid outlet joint widen in a cone shape toward the fluid chamber.

Description

壓力檢出體及具備此壓力檢出體的血液回路及血液淨化裝置 Pressure detecting body and blood circuit and blood purifying device having the same

本發明係關於壓力檢出體及具備此壓力檢出體的血液回路及血液淨化裝置。 The present invention relates to a pressure detecting body and a blood circuit and a blood purifying device including the pressure detecting body.

所謂體外循環療法,係指藉由從患者體內取出血液,使用血液淨化裝置進行血液的體外處理,再將經處理後的血液輸回體內來進行血液淨化的治療法。在該體外循環療法中,必須正確掌握體外循環中的血液壓力。因此,在體外循環回路內配置有測量壓力的壓力檢出體。以配置在體外循環回路內的壓力檢出體而言,一般係使用以下2個例子(專利文獻1及2)。 The extracorporeal circulation therapy refers to a treatment method in which blood is taken out from a patient, blood is externally treated using a blood purification device, and the treated blood is returned to the body to perform blood purification. In this extracorporeal circulation therapy, blood pressure in the extracorporeal circulation must be properly grasped. Therefore, a pressure detecting body that measures pressure is disposed in the extracorporeal circuit. In the case of the pressure detecting body disposed in the extracorporeal circuit, the following two examples are generally used (Patent Documents 1 and 2).

在專利文獻1中揭示了一種壓力測量裝置,其具有為了使血液不會接觸空氣,而利用屬於可撓性薄板的膜片(diaphragm)(會因應體液循環回路內的壓力而變形的膜)使內部分隔為血液室和空氣室的盒體(壓力檢出體)。在該盒體內,膜片的至少一部分會因充滿於血液室內之血液的壓力而變形,故可透過測量該膜片的變形量來測量體外循環回路內的壓力。 Patent Document 1 discloses a pressure measuring device having a diaphragm which is a flexible thin plate (a film which is deformed in response to pressure in a body fluid circulation circuit) so that blood does not come into contact with air. A box (pressure detector) that is internally divided into a blood chamber and an air chamber. In the case, at least a part of the diaphragm is deformed by the pressure of the blood filled in the blood chamber, so that the pressure in the extracorporeal circuit can be measured by measuring the amount of deformation of the diaphragm.

專利文獻2中揭示了一種壓力感測器,其係著 眼於血液會隨著滯留而凝固,而將屬於用以使液體導入盒體(壓力檢出體)之流路的液體流出口及液體流入口設計成液體流出口配置在距離液體流入口1/2周以上未達1周的位置的方式。該壓力感測器中,藉著將液體流出口配置在距離液體流入口1/2周以上未達1周的位置,使導入盒體內的液體沿著液體室的側面內周流入,透過形成與液體室呈同心圓狀的液流來產生循環,以解除因流路的突然擴大而導致滯留,並抑制血液的凝固。 Patent Document 2 discloses a pressure sensor which is attached The blood is solidified with the retention, and the liquid outflow port and the liquid inflow port which are the flow paths for introducing the liquid into the cartridge (pressure detecting body) are designed such that the liquid outflow port is disposed at a distance from the liquid inflow port. The method of not being able to reach the position of 1 week or more for 2 weeks or more. In the pressure sensor, by arranging the liquid outflow port at a position that is less than one week from the liquid inlet port, the liquid introduced into the casing flows in along the inner circumference of the side surface of the liquid chamber, and is formed and transmitted. The liquid chamber has a concentric flow of the liquid to generate a circulation to relieve the retention due to the sudden expansion of the flow path and to inhibit the coagulation of the blood.

[先前技術文獻] [Previous Technical Literature] [專利文獻] [Patent Literature]

[專利文獻1]日本特開平09-024026號公報 [Patent Document 1] Japanese Laid-Open Patent Publication No. 09-024026

[專利文獻2]日本特開2007-282996號公報 [Patent Document 2] Japanese Patent Laid-Open Publication No. 2007-282996

然而,專利文獻1所述的壓力檢出體中,在血液進入壓力檢出體內時,入口處會因流路突然擴大,而在血液室入口附近產生滯留。因此,血流產生瘀滯,血液會在一定的位置滯留,而容易發生血液凝固的問題。再者,專利文獻2的壓力感測器中,會因循環血液的黏度或處理流量而無法產生預先設想的血液循環,而有血液因滯留容易產生血液凝固的問題。 However, in the pressure detecting body described in Patent Document 1, when the blood enters the pressure detecting body, the inlet portion suddenly expands due to the flow path, and the inlet portion is caused to stay in the vicinity of the blood chamber inlet. Therefore, blood flow is stagnant, blood is retained at a certain position, and blood coagulation is prone to occur. Further, in the pressure sensor of Patent Document 2, it is impossible to generate a blood circulation which is assumed in advance due to the viscosity of the circulating blood or the treatment flow rate, and there is a problem that blood is likely to be coagulated due to retention of blood.

因此,本發明之目的在提供一種新穎構造的壓力檢出體,其係在測量體外循環回路內的壓力而血液不會和空氣接觸的壓力檢出體中,可藉由改善壓力檢出 體內部的血流以抑制血液滯留,更進而抑制血液凝固。 Accordingly, it is an object of the present invention to provide a pressure detecting body of a novel configuration which is capable of detecting pressure by detecting pressure in an extracorporeal circuit and in a pressure detecting body in which blood does not come into contact with air. The blood flow inside the body inhibits blood retention and further inhibits blood coagulation.

本案發明人等,經一再專心銳意的研究,成功的發現使血流較習知的壓力檢出體更進一步改善,更能抑制血液凝固的壓力檢出體構造,而完成了本案發明。亦即,本發明提供了以下(1)至(5)的壓力檢出體、(7)的血液回路及(8)的血液淨化裝置。 The inventors of the present invention, after repeated and intensive research, succeeded in discovering that the blood flow is further improved than the conventional pressure detecting body, and the pressure detecting body structure for blood coagulation is more suppressed, and the invention of the present invention is completed. That is, the present invention provides the pressure detecting body of the following (1) to (5), the blood circuit of (7), and the blood purification device of (8).

(1)一種體外循環回路用壓力檢出體,係為用以測量執行血液體外處理的體外循環回路內壓力的壓力檢出體,具備:室構件,具有會因上述體外循環回路內的壓力而變形的變形面、以及液體流入口及液體流出口,且具備供上述血液流入及排出的液體室;液體流入口接頭,用以藉管子使上述液體流入口與上述體外循環回路連通;以及液體流出口接頭,用以藉管子使上述液體流出口與上述體外循環回路連通,而上述液體流入口接頭及上述液體流出口接頭內部的流路係朝上述液體室的方向擴開成錐台狀。 (1) A pressure detecting body for an extracorporeal circulation circuit, which is a pressure detecting body for measuring a pressure in an extracorporeal circuit that performs extracorporeal treatment of blood, comprising: a chamber member having a pressure due to the pressure in the extracorporeal circuit a deformed deformed surface, a liquid inflow port and a liquid outflow port, and a liquid chamber for inflow and discharge of the blood; a liquid inflow port joint for communicating the liquid inflow port with the extracorporeal circuit by a tube; and a liquid flow The outlet joint is configured to connect the liquid outflow port to the extracorporeal circulation circuit by a tube, and the liquid flow inlet joint and the flow path inside the liquid outflow joint are expanded into a truncated cone shape in a direction of the liquid chamber.

(2)如上述(1)所述的體外循環回路用壓力檢出體,其中,上述液體室為圓柱形,上述液體流入口及上述液體流出口係配置在上述液體室的圓柱側面。 (2) The pressure detecting body for an extracorporeal circulation circuit according to the above aspect, wherein the liquid chamber has a cylindrical shape, and the liquid inflow port and the liquid outflow port are disposed on a cylindrical side surface of the liquid chamber.

(3)如上述(2)所述的體外循環回路用壓力檢出體,其中,上述液體流入口圓周方向的口徑係為上述液體室之圓周長的13.9%以上50%以下。 (3) The pressure detecting body for an extracorporeal circulation circuit according to the above aspect, wherein the diameter of the liquid inflow port in the circumferential direction is 13.9% or more and 50% or less of the circumferential length of the liquid chamber.

(4)如上述(1)至(3)中任一項所述的體外循環回路用壓力檢出體,其中,上述液體流入口及上述液體流出口 係夾介著上述液體室相對向配置。 The pressure detecting body for an extracorporeal circulation circuit according to any one of the above aspects, wherein the liquid inflow port and the liquid outflow port The clips are disposed opposite each other through the liquid chamber.

(5)如上述(1)至(4)中任一項所述的體外循環回路用壓力檢出體,其中,上述液體流入口接頭及上述液體流出口接頭的形狀係為錐台狀,且以前述錐台狀的較大底面與上述液體室連結。 The pressure detecting body for an extracorporeal circulation circuit according to any one of the above aspects, wherein the liquid inflow port joint and the liquid outflow port joint have a truncated cone shape, and The larger bottom surface of the truncated cone shape is coupled to the liquid chamber.

(6)如上述(1)至(5)中任一項所述的體外循環回路用壓力檢出體,其中,上述液體流入口接頭及上述流出口接頭的內部流路係為同一形狀。 The pressure detecting body for extracorporeal circulation circuits according to any one of the above aspects, wherein the liquid flow inlet joint and the inner flow path of the outlet joint have the same shape.

(7)一種血液回路,係具備:如上述(1)至(6)中任一項所述的體外循環回路用壓力檢出體;及體外循環回路。 (7) A blood circuit comprising: the pressure detecting body for an extracorporeal circulation circuit according to any one of the above (1) to (6); and an extracorporeal circulation circuit.

(8)一種血液淨化裝置,係具備如上述(7)所述的血液回路。 (8) A blood purification device comprising the blood circuit according to (7) above.

若依本發明的壓力檢出體,由於透過使從體外循環回路流入用以構成室構件的液體室的血液流經朝向液體室方向擴開成錐台狀的液體流入口接頭,因此可使血液流速均勻,不論血液黏度或處理流量如何,均可抑制血液滯留,結果,可以抑制血液的凝固。 According to the pressure detecting body of the present invention, the blood flow rate can be made by allowing the blood flowing from the extracorporeal circulation circuit to flow into the liquid chamber constituting the chamber member to flow through the liquid inlet port joint which is expanded into a truncated cone shape toward the liquid chamber. Uniformity, regardless of blood viscosity or treatment flow rate, can inhibit blood retention, and as a result, blood coagulation can be suppressed.

1‧‧‧壓力檢出體 1‧‧‧Pressure detection body

2‧‧‧體外循環回路 2‧‧‧Extracorporeal circulation circuit

3‧‧‧液體流入口 3‧‧‧Liquid flow inlet

4‧‧‧液體流出口 4‧‧‧Liquid outlet

5‧‧‧液體室 5‧‧‧Liquid room

6‧‧‧壓力測量裝置 6‧‧‧ Pressure measuring device

7‧‧‧空氣室 7‧‧ Air Room

8‧‧‧變形面 8‧‧‧ deformed surface

9‧‧‧室構件 9‧‧‧ room components

10‧‧‧液體流入口接頭 10‧‧‧Liquid flow inlet fittings

11‧‧‧液體流出口接頭 11‧‧‧Liquid outlet connector

12‧‧‧液體室內側隅部 12‧‧‧Liquid indoor side crotch

13‧‧‧液體室內側隅部 13‧‧‧Liquid indoor side crotch

14‧‧‧液體室內側隅部 14‧‧‧Liquid indoor side crotch

15‧‧‧血液回路 15‧‧‧ Blood circuit

16‧‧‧滴室 16‧‧‧Drip room

17‧‧‧基板 17‧‧‧Substrate

18‧‧‧血液淨化裝置 18‧‧‧ Blood purification device

19‧‧‧操作面板 19‧‧‧Operator panel

20‧‧‧單元組件座 20‧‧‧Unit kit

21‧‧‧血液泵 21‧‧‧ blood pump

22‧‧‧藥液架 22‧‧‧drug rack

23‧‧‧血液淨化用單元組件 23‧‧‧cell components for blood purification

24‧‧‧液體流入口圓周方向的口徑 24‧‧‧Caliber in the circumferential direction of the liquid inlet

圖1為從側面顯示本發明壓力檢出體實施樣態的示意圖。 BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic view showing the state of the pressure detecting body of the present invention from the side.

圖2為從上面顯示本發明壓力檢出體實施樣態的示意圖。 Fig. 2 is a schematic view showing the state of the pressure detecting body of the present invention from the above.

圖3為顯示本發明壓力檢出體的另一實施樣態的示意圖。 Fig. 3 is a schematic view showing another embodiment of the pressure detecting body of the present invention.

圖4為顯示具有本發明壓力檢出體的血液回路實施樣態的示意圖。 Fig. 4 is a schematic view showing a blood circuit embodiment of the pressure detecting body of the present invention.

圖5為顯示具有本發明壓力檢出體的血液淨化裝置實施樣態的示意圖。 Fig. 5 is a schematic view showing an embodiment of a blood purification apparatus having the pressure detecting body of the present invention.

圖6為從上面顯示用於實施例1的本發明壓力檢出體的構成要素的示意圖。 Fig. 6 is a schematic view showing the constituent elements of the pressure detecting body of the present invention used in the first embodiment from the above.

圖7為對用於實施例1的本發明壓力檢出體顯示(a)流通墨汁前、(b)流通墨汁後的各種流動狀態的圖示。 Fig. 7 is a view showing various flow states after (b) ink flow and (b) ink flow after the pressure detecting body of the present invention used in the first embodiment.

圖8為從上面顯示用於比較例1的習知壓力檢出體的構成要素的示意圖。 Fig. 8 is a schematic view showing the constituent elements of the conventional pressure detecting body used in Comparative Example 1 from the above.

圖9為對用於比較例1的習知壓力檢出體顯示(a)流通墨汁前、(b)流通墨汁後的各種流動狀態確認結果的圖示。 Fig. 9 is a view showing the results of confirmation of various flow states after (b) before the ink is circulated and (b) after the ink is circulated, for the conventional pressure detecting body used in Comparative Example 1.

圖10為從上面顯示用於比較例2的壓力檢出體構成要素的示意圖。 Fig. 10 is a schematic view showing the components of the pressure detecting body used in Comparative Example 2 from the above.

[實施發明之形態] [Formation of the Invention]

本發明的體外循環回路用壓力檢出體,係為以測量執行血液體外處理的體外循環回路內的壓力為目的的壓力檢出體,其特徵在具備:室構件,具有因上述體外循環回路內的壓力而變形的變形面、以及液體流入口及液體流出口,且具備供上述血液流入及排出的液體室;液體流入口接頭,用以藉管子使上述液體流入口與 上述體外循環回路連通;以及液體流出口接頭,用以藉管子使上述液體流出口與上述體外循環回路連通,而上述液體流入口接頭及上述液體流出口接頭內部的流路係朝向上述液體室方向擴開成錐台狀。 The pressure detecting body for the extracorporeal circulation circuit of the present invention is a pressure detecting body for measuring the pressure in the extracorporeal circuit that performs the extracorporeal treatment of blood, and is characterized in that it has a chamber member and is provided in the extracorporeal circuit. a pressure-deformed deformed surface, and a liquid inflow port and a liquid outflow port, and a liquid chamber for inflow and discharge of the blood; a liquid inflow port joint for allowing the liquid inflow port to be The extracorporeal circulation circuit is connected; and the liquid outflow port is configured to communicate the liquid outflow port with the extracorporeal circuit by a tube, and the liquid inflow port and the flow path inside the liquid outflow port are oriented toward the liquid chamber Expanded into a truncated cone shape.

所謂「體外循環回路」係為供從人體抽出的血液流通的管狀流路。「變形面」係形成為會因體外循環回路內壓力而使其至少一部分變形,且為構成室構件之一部分的面。「液體流入口」係為用以供血液流入室構件內之液體室的入口,「液體流出口」係為用以供血液從室構件內之液體室排出為目的的出口。「液體流入口接頭」係為使體外循環回路與液體流入口連通的流路,「液體流出口接頭」係為使體外循環回路與液體流出口連通的流路。 The "extracorporeal circulation circuit" is a tubular flow path through which blood drawn from a human body flows. The "deformed surface" is formed into a surface that is at least partially deformed by the pressure in the extracorporeal circuit and is a part of the chamber member. The "liquid inlet" is an inlet for supplying blood into the liquid chamber in the chamber member, and the "liquid outlet" is an outlet for discharging blood from the liquid chamber in the chamber member. The "liquid inflow port joint" is a flow path that allows the extracorporeal circuit to communicate with the liquid inflow port, and the "liquid outflow port" is a channel that allows the extracorporeal circuit to communicate with the liquid outflow port.

以下,參照圖式說明上述體外循環回路用壓力檢出體的較佳實施形態。圖1及2係為顯示上述體外循環回路用壓力檢出體之實施形態的示意圖。 Hereinafter, a preferred embodiment of the pressure detecting body for the extracorporeal circulation circuit will be described with reference to the drawings. 1 and 2 are schematic views showing an embodiment of the pressure detecting body for the extracorporeal circulation circuit.

在圖1及2中,壓力檢出體1具備室構件9,其具有:連接到體外循環回路2,具有會因體外循環回路內之壓力而變形的變形面8、以及液體流入口3及液體流出口4,供血液流入及排出的液體室5;以及鄰接於液體室5,且配置成夾介上述變形面8的空氣室7。空氣室7係與壓力測量裝置6連接。而且,具備:室構件9;用以使液體流入口3與體外循環回路2連通的液體流入口接頭10;及用以使液體流出口4和體外循環回路2連通的液體流出口接頭11。在此,在液體室5的流路與液體流入口接頭10 的流路相連接的面上,係將液體室圓周方向的液體流入口口徑設為液體流入口圓周方向的口徑24。再者,為了抑制流動於壓力檢出體1內的液體滯留在液體室5,液體流入口接頭10及液體流出口接頭11的形狀較佳為可順利連接液體流入口3及液體流出口4與液體室5的形狀。具體的形狀雖然可按照液體流速或黏度而適當設計,但較佳為使液體流入口接頭10及液體流出口接頭11內部的流路構成為朝向液體室5側方向擴開成錐台狀。 In Figs. 1 and 2, the pressure detecting body 1 is provided with a chamber member 9 having a connection to the extracorporeal circuit 2, a deformed surface 8 which is deformed by the pressure in the extracorporeal circuit, and a liquid inflow port 3 and a liquid. The outflow port 4, the liquid chamber 5 for supplying and discharging blood, and the air chamber 7 adjacent to the liquid chamber 5 and disposed to sandwich the deformed surface 8. The air chamber 7 is connected to the pressure measuring device 6. Further, a chamber member 9 is provided; a liquid inflow port 10 for communicating the liquid inflow port 3 with the extracorporeal circuit 2; and a liquid outflow port 11 for communicating the liquid outflow port 4 with the extracorporeal circuit 2. Here, the flow path and liquid inflow port joint 10 in the liquid chamber 5 The surface on which the flow paths are connected is such that the diameter of the liquid inflow in the circumferential direction of the liquid chamber is the diameter 24 in the circumferential direction of the liquid inflow port. Further, in order to suppress the liquid flowing in the pressure detecting body 1 from remaining in the liquid chamber 5, the shape of the liquid inflow port joint 10 and the liquid outflow port joint 11 is preferably such that the liquid inflow port 3 and the liquid outflow port 4 can be smoothly connected. The shape of the liquid chamber 5. Although the specific shape can be appropriately designed according to the liquid flow rate or viscosity, it is preferable that the flow path inside the liquid inflow port joint 10 and the liquid outflow port joint 11 is configured to expand in a frustum shape toward the liquid chamber 5 side.

測量壓力的手段係為以夾介液體室5和空氣室7的方式配置的變形面8,其會因在液體室5流動的血液壓力而變形,藉由以間接方式檢測其變形量而測得體外循環回路2內的壓力。具體而言,形成為變形面8與壓力測量裝置6之間的氣密式空間的空氣室7中,隨著變形面8的變形,會在空氣室7內產生壓力變化,透過使用壓力測量裝置6測量該壓力變化,而間接地測得體外循環回路2內的壓力。 The means for measuring the pressure is a deformed surface 8 which is disposed so as to sandwich the liquid chamber 5 and the air chamber 7, which is deformed by the blood pressure flowing in the liquid chamber 5, and is measured by indirectly detecting the amount of deformation thereof. The pressure inside the extracorporeal circuit 2. Specifically, in the air chamber 7 formed as a hermetic space between the deformed surface 8 and the pressure measuring device 6, a pressure change occurs in the air chamber 7 as the deformed surface 8 is deformed, and a pressure measuring device is used. 6 The pressure change is measured, and the pressure in the extracorporeal circuit 2 is measured indirectly.

作為壓力測量方法,如圖3所示,也可以使用透過以負載感測器或變形計等直接測量變形面8的變形量,而測得體外循環回路2內之壓力的方法。壓力測量方法並無特別限定,只要能正確測量體外循環回路內的壓力就沒有問題。 As a pressure measuring method, as shown in FIG. 3, a method of measuring the pressure in the extracorporeal circuit 2 by directly measuring the amount of deformation of the deformed surface 8 by a load sensor or a strain gauge or the like may be used. The pressure measuring method is not particularly limited as long as the pressure in the extracorporeal circuit can be accurately measured.

在圖2中,雖然液體室5係呈圓柱形狀,但液體室5的形狀並不受限定,例如也可以是六角柱液體室之類的多角柱形狀。再者,和變形面8平行的液體室5的任意剖面形狀與變形面8,即使為不同的形狀、大小,也不 會有特別的問題。然而,為了更不會產生血液滯留,並形成順暢的血流,較佳為液體室5形成圓柱形的同時,變形面8形成為具有與液體室5相同圓半徑的圓形膜。 In FIG. 2, although the liquid chamber 5 has a cylindrical shape, the shape of the liquid chamber 5 is not limited, and may be, for example, a polygonal column shape such as a hexagonal column liquid chamber. Further, the arbitrary cross-sectional shape of the liquid chamber 5 parallel to the deformed surface 8 and the deformed surface 8 are not different in shape and size. There will be special problems. However, in order to prevent blood from escaping and to form a smooth blood flow, it is preferable that the liquid chamber 5 is formed into a cylindrical shape while the deformed surface 8 is formed as a circular film having the same circular radius as that of the liquid chamber 5.

再者,在圖1中,液體室5的側面雖然從橫剖面來看係呈直線狀,但以任意角度傾斜都不會有問題。 Further, in Fig. 1, the side surface of the liquid chamber 5 is linear in cross section, but there is no problem in tilting at an arbitrary angle.

再者,如圖1所示,雖然屬於液體室5的內側隅部的液體室內側隅部12、13、14係為直角,但是隅部也可具有圓弧。為了形成更流暢的液流,液體室5的內側隅部較佳為具有某種程度的圓形。 Further, as shown in Fig. 1, although the liquid chamber side dams 12, 13, and 14 belonging to the inner crotch portion of the liquid chamber 5 are at right angles, the crotch portion may have an arc. In order to form a smoother flow, the inner crotch portion of the liquid chamber 5 preferably has a certain degree of circular shape.

而且,在圖1中,雖然變形面8的形狀係呈平板形的膜,但即使從橫剖面看來呈波浪形等也不會有問題。再者,變形面8並不一定要以整個面變形,變形面8變形部分的面積或形狀只要能正確測量壓力,何種比例的面積或形狀皆可,不特別限定。 Further, in Fig. 1, although the shape of the deformed surface 8 is a flat plate-shaped film, there is no problem even if it is wavy or the like from the cross section. Further, the deformed surface 8 does not have to be deformed by the entire surface, and the area or shape of the deformed portion of the deformed surface 8 is not particularly limited as long as the pressure can be accurately measured.

再者,在圖2中,雖然朝向液體流入口3及液體流出口4呈錐台狀的液體流入口接頭10及液體流出口接頭11的流路係對變形面8成平行流入,但也可對變形面8形成角度。然而,為了形成更流暢的血流,呈錐台狀的液體流入口接頭10及液體流出口接頭11較佳為配置成使血液對變形面8以0至30度的角度範圍流入室構件9,更佳為在0至15度範圍,最佳為以平行流入的方式配置。 In addition, in FIG. 2, the flow path of the liquid inflow port joint 10 and the liquid outflow port joint 11 which are tapered toward the liquid inflow port 3 and the liquid outflow port 4 flow in parallel to the deformed surface 8, but it is also possible. An angle is formed on the deformed surface 8. However, in order to form a smoother blood flow, the fritted liquid inflow port joint 10 and the liquid outflow port joint 11 are preferably arranged such that blood flows into the chamber member 9 at an angular range of 0 to 30 degrees with respect to the deformed surface 8. More preferably in the range of 0 to 15 degrees, it is preferably configured in a parallel inflow manner.

如圖1所示,雖液體流入口3及液體流出口4係相對於液體室5側面的高度方向設置在中間位置,但也可使液體流入口的位置相對於側面的高度方向偏離中間位置。再者,也可以使液體流入口3及液體流出口4的位 置相對於液體室5側面的高度方向在液體室5側面上自同一軸上偏離。然而,為了形成更流暢的液流,液體流入口3及液體流出口4相對於液體室5側面的高度方向以位在中間位置為佳,再者,相對於液體室5的高度方向,液體流入口3及液體流出口4的位置較佳為在液體室5側面上位於同一軸上。 As shown in Fig. 1, although the liquid inflow port 3 and the liquid outflow port 4 are provided at an intermediate position with respect to the height direction of the side surface of the liquid chamber 5, the position of the liquid inflow port may be shifted from the intermediate position with respect to the height direction of the side surface. Furthermore, the positions of the liquid inflow port 3 and the liquid outflow port 4 can also be made. The height direction with respect to the side surface of the liquid chamber 5 is deviated from the same axis on the side of the liquid chamber 5. However, in order to form a smoother liquid flow, it is preferable that the liquid inflow port 3 and the liquid outflow port 4 are positioned at an intermediate position with respect to the height direction of the side surface of the liquid chamber 5, and further, the liquid flow with respect to the height direction of the liquid chamber 5 The positions of the inlet 3 and the liquid outflow port 4 are preferably located on the same axis on the side of the liquid chamber 5.

如圖2所示,用以藉管子使液體流入口3和體外循環回路2連通的液體流入口接頭10,其內部的流路係朝向液體室5方向擴開成錐台狀。如此,液體流入口接頭10與液體室5連接的部分,亦即,液體流入口3的圓周方向口徑24較佳為大於體外循環回路2。再者,呈錐台狀的液體流入口接頭10的任意剖面,為了形成與體外循環回路2等效的流動阻力,最佳為符合下式1的關係。 As shown in Fig. 2, the liquid inflow port joint 10 for communicating the liquid inflow port 3 and the extracorporeal circulation circuit 2 by means of a tube has its inner flow path expanded into a truncated cone shape toward the liquid chamber 5. Thus, the portion of the liquid inflow port 10 that is connected to the liquid chamber 5, that is, the circumferential direction 24 of the liquid inflow port 3 is preferably larger than the extracorporeal circuit 2. Further, in any cross section of the liquid flow inlet joint 10 having a truncated cone shape, in order to form a flow resistance equivalent to that of the extracorporeal circulation circuit 2, it is preferable to conform to the relationship of the following formula 1.

De=4Af/Wp‧‧‧(式1) De=4Af/Wp‧‧‧(Form 1)

此處,De表示體外循環回路內徑,Af表示液體流入口接頭任意位置的剖面積,Wp表示液體流入口接頭任意位置的剖面周長。 Here, De represents the inner diameter of the extracorporeal circuit, Af represents the cross-sectional area of the liquid flow inlet joint at any position, and Wp represents the cross-sectional circumference of the liquid flow inlet joint at any position.

雖液體流入口3係藉液體流入口接頭10與液體室5的連接面所構成,但該連接面,亦即液體流入口3的圓周方向口徑24,只要符合式1的關係即可。然而,為了在液體室5內形成更均勻順暢的液流,液體流入口3圓周方向的口徑24較佳為液體室5圓周長的13.9%以上。另一方面,液體流入口3的圓周方向口徑24相對於液體室5圓周長為50%以上時,流體流入口接頭10即不能成為錐台狀。亦即,液體流入口3的圓周方向口徑24最佳為液體 室5圓周長的13.9%以上50%以下的範圍內。 Although the liquid inflow port 3 is constituted by the connection surface of the liquid inflow port joint 10 and the liquid chamber 5, the connection surface, that is, the circumferential direction diameter 24 of the liquid inflow port 3 may be in accordance with the relationship of Formula 1. However, in order to form a more uniform and smooth flow in the liquid chamber 5, the diameter 24 of the liquid inlet 3 in the circumferential direction is preferably 13.9% or more of the circumference of the liquid chamber 5. On the other hand, when the circumferential direction diameter 24 of the liquid inflow port 3 is 50% or more with respect to the circumference of the liquid chamber 5, the fluid inflow port joint 10 cannot be in a truncated cone shape. That is, the circumferential direction diameter 24 of the liquid inflow port 3 is preferably a liquid The circumference of the chamber 5 is in the range of 13.9% or more and 50% or less.

如圖2所示,雖然液體流入口3與液體流出口4係夾介著室構件9設置在相對位置,但也可以從相對位置錯開。然而,為了形成更流暢的液流,仍以相對位置最佳。此處所指的相對位置,係以液體室5的中心為軸處於對稱關係的情形。 As shown in Fig. 2, although the liquid inflow port 3 and the liquid outflow port 4 are disposed at a relative position with respect to the chamber member 9, they may be shifted from the relative position. However, in order to create a smoother flow, the relative position is still optimal. The relative position referred to here is a case where the center of the liquid chamber 5 is in a symmetrical relationship.

再者,如圖2所示,雖然液體流入口3及液體流出口4係形成同一形狀,但即使液體流出口4與液體室5的設置面積比液體流入口3小,也不會使上述發明的功效降低。然而,在壓力檢出體1的成形性、防止體外循環回路2的安裝錯誤方面,且為了形成更流暢、均勻的液流,流體流入口3及液體流出口4最佳為同一形狀。 Further, as shown in FIG. 2, although the liquid inflow port 3 and the liquid outflow port 4 are formed in the same shape, even if the installation area of the liquid outflow port 4 and the liquid chamber 5 is smaller than the liquid inflow port 3, the above invention is not caused. The efficacy is reduced. However, the fluid inflow port 3 and the liquid outflow port 4 preferably have the same shape in terms of moldability of the pressure detecting body 1 and prevention of mounting error of the extracorporeal circuit 2, and in order to form a smoother and more uniform liquid flow.

液體室5以及空氣室7的材質,雖然並不特別講究其為硬質或軟質,但若因液溫或氣溫會使液體室5或空氣室7變形的外力等環境因素,而使液體室5及空氣室7的形狀產生變化時,要正確測量體外循環回路2內的壓力會變得困難。因此,液體室5及空氣室7的材質以硬質為佳,並且由於會直接或間接的接觸患者的血液,故以具有生體適應性的材質為佳。可列舉有例如氯乙烯、聚碳酸酯、聚丙烯、聚乙烯、聚氨酯等,其中任一種皆適於使用。再者,雖然其製造方法並不特別限定,但可使用例如射出成形、吹氣成形、切削加工成形等。 Although the material of the liquid chamber 5 and the air chamber 7 is not particularly hard or soft, the liquid chamber 5 and the liquid chamber 5 may be caused by environmental factors such as an external force that deforms the liquid chamber 5 or the air chamber 7 due to liquid temperature or temperature. When the shape of the air chamber 7 changes, it becomes difficult to accurately measure the pressure in the extracorporeal circuit 2. Therefore, the material of the liquid chamber 5 and the air chamber 7 is preferably hard, and since it directly or indirectly contacts the blood of the patient, it is preferable to use a material having biocompatibility. For example, vinyl chloride, polycarbonate, polypropylene, polyethylene, polyurethane, etc. may be mentioned, and any of them are suitable for use. In addition, although the manufacturing method is not particularly limited, for example, injection molding, air blowing molding, cutting processing, or the like can be used.

變形面8的材質若為硬質,藉壓力所產生的變形量會變小,要正確測量體外循環回路2內的壓力變得困難,故以能對壓力產生柔軟變形的軟性材質為佳。而且 ,由於會直接或間接的接觸患者的血液,故以具有生體適應性的材質為佳。例如,雖可使用聚氯乙烯、矽氧基樹脂、苯乙烯基熱可塑性橡膠、苯乙烯基熱可塑性橡膠化合物等,但並不僅限於此,只要是具有生體適應性的素材,任何材質皆可適用。 If the material of the deformed surface 8 is hard, the amount of deformation by the pressure becomes small, and it is difficult to accurately measure the pressure in the extracorporeal circuit 2, so that a soft material which can softly deform the pressure is preferable. and Since the blood of the patient is directly or indirectly contacted, it is preferable to use a material having biocompatibility. For example, although polyvinyl chloride, a decyloxy resin, a styrene-based thermoplastic rubber, a styrene-based thermoplastic rubber compound, or the like can be used, it is not limited thereto, and any material can be used as long as it is biocompatible. Be applicable.

體外循環回路2的材質雖可使用合成樹脂、金屬及玻璃等之任一種材質,但從製造成本、加工性及操作性的觀點來看,以使用合成樹脂,特別是熱可塑性樹脂為佳。以熱可塑性樹脂而言,可以使用例如聚烯烴系樹脂、聚醯胺系樹脂、聚酯系樹脂、聚氨酯系樹脂、氟系樹脂、矽氧系樹脂等,還可使用ABS樹脂、聚氯乙烯、聚碳酸酯、聚苯乙烯、聚丙烯酸、聚縮醛等。其中,軟質材因為耐彎曲性或耐斷裂性等很強,操作時的柔軟性優異,故較佳,而若從組裝性的觀點來看,軟質氯乙烯特佳。 The material of the extracorporeal circuit 2 can be any material such as synthetic resin, metal, or glass. However, from the viewpoints of production cost, workability, and workability, it is preferred to use a synthetic resin, particularly a thermoplastic resin. For the thermoplastic resin, for example, a polyolefin resin, a polyamide resin, a polyester resin, a urethane resin, a fluorine resin, a fluorene resin, or the like can be used, and an ABS resin or a polyvinyl chloride resin can also be used. Polycarbonate, polystyrene, polyacrylic acid, polyacetal, and the like. Among them, the soft material is excellent in bending resistance, fracture resistance, and the like, and is excellent in flexibility at the time of handling, and is preferably excellent in soft vinyl chloride from the viewpoint of assemblability.

液體流入口接頭10及液體流出口接頭11的材質並不講究其為硬質或軟質,雖可使用合成樹脂、金屬及玻璃等之任一種,但由於會直接或間接的接觸患者的血液,故以具有生體適應性的材質為佳。再者,從製造成本、加工性、組裝性的觀點來看,以使用與液體室5及空氣室7相同的材質為佳。可使用例如氯乙烯、聚碳酸酯、聚丙烯、聚乙烯、聚氨酯等。再者,雖然其製造方法並不特別限定,但具體而言可使用射出成形、吹塑(blow)成形、切削加工等。此外,體外循環回路2與液體流入口接頭10及液體流出口接頭11也可用一體成型。 The material of the liquid inflow port joint 10 and the liquid outflow port joint 11 is not hard or soft. Although any of synthetic resin, metal, glass, and the like can be used, since the patient's blood is directly or indirectly contacted, A material with biocompatibility is preferred. Further, from the viewpoints of production cost, workability, and assembly property, it is preferable to use the same material as the liquid chamber 5 and the air chamber 7. For example, vinyl chloride, polycarbonate, polypropylene, polyethylene, polyurethane, or the like can be used. Further, although the production method thereof is not particularly limited, specifically, injection molding, blow molding, cutting processing, or the like can be used. Further, the extracorporeal circuit 2 and the liquid inflow port 10 and the liquid outflow port 11 may be integrally formed.

液體室5、空氣室7、變形面8、液體流入口接頭10、液體流出口接頭11及體外循環回路2各自的接合方法,雖然並無特別限定,但一般而言,合成樹脂的接合可舉出熱熔接或黏接等方法。例如,在熱熔接中,可以舉出高周波熔接、感應加熱熔接、超音波熔接、摩擦熔接、旋摩熔接、熱板熔接、熱線熔接等方法。在黏接方面,可舉出有使用氰丙烯酸酯系、環氧系、聚氨酯系、合成橡膠系、紫外線硬化型、變性丙烯醯系樹脂、熱熔型等的黏接方式。 The bonding method of each of the liquid chamber 5, the air chamber 7, the deformed surface 8, the liquid inflow port joint 10, the liquid outflow port joint 11, and the extracorporeal circulation circuit 2 is not particularly limited, but in general, the joining of the synthetic resin is exemplified. Heat fusion or bonding. For example, in the thermal fusion bonding, methods such as high-frequency welding, induction heating welding, ultrasonic welding, friction welding, friction welding, hot plate welding, and hot wire welding can be cited. Examples of the bonding method include a bonding method using a cyanoacrylate type, an epoxy type, a polyurethane type, a synthetic rubber type, an ultraviolet curing type, a denatured acryl resin, and a hot melt type.

再者,一般在硬質材質與軟性材質的接合上,可舉出有藉由使硬質材質壓入而將軟性材質封合(seal)的機械式封合,或如上述所揭示的熱熔接合或黏接等。 In addition, generally, in the joining of a hard material and a soft material, a mechanical seal which seals a soft material by pressing a hard material, or a heat fusion joint as disclosed above or Bonding, etc.

此種壓力檢出體1雖然可在成型、接合後直接以該狀態使用,特別是在體外循環療法的醫療用途中,經殺菌後就加以利用。殺菌方法可準用通常醫療用具的殺菌方法,以藥液、瓦斯、放射線、高壓蒸氣、加熱等進行殺菌即可。 Such a pressure detecting body 1 can be directly used in this state after molding and joining, and is particularly used in medical use of extracorporeal circulation therapy after sterilization. The sterilization method can be sterilized by a sterilization method of a general medical device, and can be sterilized by a chemical liquid, gas, radiation, high-pressure steam, heating, or the like.

壓力檢出體1的液體室5、空氣室7、變形面8的大小,若太大,則容積會增大,結果,會產生吸量(priming volume)增大的問題;相反的,若太小,則由於體外循環回路內的壓力變成負壓,使變形面8凸向液體室側,導致變形面8塞住液體流入口3或液體流出口4,而產生血液不流通的問題。因此,液體室5的大小,容積以1至10cm3左右為佳,更佳為1至5cm3左右,最佳為1至3cm3左右。空氣室7的大小若太大,負壓時由於變形面8會往 液體室側大幅變形,使變形面8塞住液體流入口3或液體流出口4,產生血液不流通的問題。再者,相反的,若太小,則在正壓時,變形面8會變得容易接觸空氣室內壁面,使壓力測量精確度降低。因此,空氣室7的大小,以容積而言,以0.2至1.0cm3為佳,更佳為0.3至0.8cm3If the size of the liquid chamber 5, the air chamber 7, and the deformed surface 8 of the pressure detecting body 1 is too large, the volume will increase, and as a result, a problem of an increase in the priming volume will occur; Small, since the pressure in the extracorporeal circuit becomes a negative pressure, the deformed surface 8 is convex toward the liquid chamber side, causing the deformed surface 8 to block the liquid inflow port 3 or the liquid outflow port 4, thereby causing a problem that blood does not flow. Therefore, the size of the liquid chamber 5 is preferably about 1 to 10 cm 3 , more preferably about 1 to 5 cm 3 , and most preferably about 1 to 3 cm 3 . If the size of the air chamber 7 is too large, the deformed surface 8 will be largely deformed toward the liquid chamber side during the negative pressure, and the deformed surface 8 will block the liquid inflow port 3 or the liquid outflow port 4, causing a problem that blood does not flow. Furthermore, conversely, if it is too small, the deformed surface 8 will easily come into contact with the inner wall surface of the air during positive pressure, so that the accuracy of pressure measurement is lowered. Thus, the size of the air chamber 7, in terms of volume, preferably 0.2 to 1.0cm 3, more preferably from 0.3 to 0.8cm 3.

再者,本發明血液回路的特徵為具備:上述體外循環回路用壓力檢出體、及上述體外循環回路。 Furthermore, the blood circuit of the present invention is characterized by comprising: the pressure detecting body for the extracorporeal circulation circuit; and the extracorporeal circulation circuit.

作為上述血液回路的實施形態,圖4顯示了具有壓力檢出體1及體外循環回路2的血液回路15。血液回路15係為藉體外循環回路2將壓力檢出體1或滴室(dripping room)16等連接的構成。在此,所謂連接,可以是單純各自相連,也可以是壓力檢出體1、滴室16、體外循環回路2等在預定位置安裝於由硬質或軟質素材製成的基板17的構成。在使用基板17的情況中,從安裝到血液淨化裝置或由此拆卸,或壓力檢出體1或體外循環回路2等的安裝拆卸的觀點來看,以使用硬質素材為佳。具體而言,可以使用ABS樹脂、聚丙烯、尼龍、聚氯乙烯、聚碳酸酯、聚醚碸、乙烯對苯二甲酸酯。 As an embodiment of the blood circuit described above, FIG. 4 shows a blood circuit 15 having a pressure detecting body 1 and an extracorporeal circuit 2. The blood circuit 15 is configured to connect the pressure detecting body 1 or the dripping chamber 16 or the like by the extracorporeal circulation circuit 2. Here, the connection may be simply connected to each other, or the pressure detecting body 1, the dropping chamber 16, and the extracorporeal circulation circuit 2 may be attached to the substrate 17 made of hard or soft material at a predetermined position. In the case of using the substrate 17, it is preferable to use a hard material from the viewpoint of attachment to the blood purification device or the detachment thereof, or the attachment and detachment of the pressure detecting body 1 or the extracorporeal circulation circuit 2 or the like. Specifically, ABS resin, polypropylene, nylon, polyvinyl chloride, polycarbonate, polyether oxime, and ethylene terephthalate can be used.

再者,本發明的血液淨化裝置係以具備上述血液回路為其特徵。 Furthermore, the blood purification device of the present invention is characterized by having the blood circuit described above.

作為上述血液回路的實施形態,圖5顯示了具有血液回路15的血液淨化裝置18。血液淨化裝置18係形成為在預定位置配置有操作板19、單元組件座(module holder)20、血液泵21、藥液架22等的構成,並往該處設置血液回路15與血液淨化用單元組件23等,且使各單元 相連接。血液淨化裝置18係在配合所使用的血液淨化用單元組件23進行設定後,使用於血液淨化療法。 As an embodiment of the blood circuit described above, FIG. 5 shows a blood purification device 18 having a blood circuit 15. The blood purification device 18 is configured such that an operation panel 19, a module holder 20, a blood pump 21, a drug solution rack 22, and the like are disposed at predetermined positions, and a blood circuit 15 and a blood purification unit are provided there. Component 23, etc., and each unit Connected. The blood purification device 18 is used for blood purification therapy after being set by the blood purification unit unit 23 used in combination.

[實施例] [Examples]

由於已藉實施例確認了上述壓力檢出體的效果,故將其具體說明於下。 Since the effect of the above-described pressure detecting body has been confirmed by the embodiment, it will be specifically described below.

(實施例1) (Example 1)

使用如圖6所示構成的壓力檢出體,以下述1)至5)的方法進行液體流動狀況的確認。 The liquid flow condition was confirmed by the following methods 1) to 5) using the pressure detecting body configured as shown in Fig. 6 .

1)作為模擬血液流通於體外循環回路及壓力檢出體的第一液體係採用三仙膠(xthane gum)水溶液(濃度750mg/L),使用送液泵以30ml/分鐘的流量進行送液,對體外循環回路及壓力檢出體進行充填。 1) As the first liquid system in which the simulated blood flows through the extracorporeal circulation circuit and the pressure detecting body, an aqueous solution of xthane gum (concentration: 750 mg/L) was used, and the liquid was supplied at a flow rate of 30 ml/min using a liquid feeding pump. The extracorporeal circuit and the pressure detector are filled.

2)三仙膠水溶液的充分充填狀態經確認後,在送液泵保持運轉(30ml/分鐘)的狀態下,從壓力檢出體的液體流入口側的體外循環回路流入適量墨汁。 2) After the liquid-filled pump is kept in operation (30 ml/min), an appropriate amount of ink flows from the extracorporeal circulation circuit on the liquid inlet side of the pressure detecting body.

3)經實施上述1)及2)後,以目視確認在壓力檢出體的液體室內的墨汁流動狀態。 3) After carrying out the above 1) and 2), the ink flow state in the liquid chamber of the pressure detecting body was visually confirmed.

4)在液體流入口及液體流出口連接內徑3.0mm左右的軟質氯乙烯管作為體外循環回路,送液泵則設置在液體流入口側的體外循環回路上。 4) A soft vinyl chloride tube having an inner diameter of about 3.0 mm is connected to the liquid inflow port and the liquid outflow port as an extracorporeal circulation circuit, and the liquid supply pump is disposed on the extracorporeal circuit on the liquid inflow side.

5)壓力檢出體的血液室容積設為大約2.3cm3,連通體外循環回路與液體室的流路設為錐台狀,相對於液體室的圓周,液體流入口的圓周方向口徑A係設為33.3%。液體流入口與液體流出口則夾介著室構件配置在相對位置,而作為壓力檢出體。另外,本實施例的壓力檢出體 係以確認液體室的流動狀態為目的,由於不進行壓力測量,故僅以聚碳酸酯製作液體室。 5) The volume of the blood chamber of the pressure detecting body is set to be about 2.3 cm 3 , and the flow path connecting the extracorporeal circuit and the liquid chamber is in the shape of a truncated cone, and the circumferential direction of the liquid inflow port A is set with respect to the circumference of the liquid chamber. It is 33.3%. The liquid inflow port and the liquid outflow port are disposed at opposite positions with respect to the chamber member as a pressure detecting body. Further, in the pressure detecting system of the present embodiment, for the purpose of confirming the flow state of the liquid chamber, since the pressure measurement is not performed, the liquid chamber is made only of polycarbonate.

測試結果,將墨汁流入到圖7(a)所示的以三仙膠水溶液充填的液體室時,如圖7(b)所示,可以確認到:從液體流入口至液體流出口,墨汁可均勻充填、循環於其間。 As a result of the test, when the ink flows into the liquid chamber filled with the aqueous solution of the Sanxian gum shown in Fig. 7(a), as shown in Fig. 7(b), it can be confirmed that the ink can be supplied from the liquid inflow port to the liquid outflow port. Evenly fill and circulate between them.

(比較例1) (Comparative Example 1)

另一方面,作為比較例1,係使用其構成如圖8所示的壓力檢出體,並以下述方法進行流動狀態的確認。液體室與實施例1為相同尺寸,液體流入口與液體流出口採用內徑3.0mm左右的體外循環回路直接連接(於液體室)的結構,而且,如圖8所示,設成液體流入口及液體流出口彼此配置在附近的構成。另外,本比較例的壓力檢出體係以確認液體室的流動狀態為目的,由於不進行壓力測量,故僅以聚碳酸酯製作液體室。 On the other hand, as Comparative Example 1, a pressure detecting body as shown in Fig. 8 was used, and the flow state was confirmed by the following method. The liquid chamber has the same size as that of the first embodiment, and the liquid inflow port and the liquid outflow port are directly connected (in the liquid chamber) by an extracorporeal circulation circuit having an inner diameter of about 3.0 mm, and, as shown in FIG. 8, a liquid inflow port is provided. And the liquid flow outlets are arranged in the vicinity of each other. Further, in the pressure detecting system of the comparative example, for the purpose of confirming the flow state of the liquid chamber, since the pressure measurement was not performed, the liquid chamber was made only of polycarbonate.

測試結果,將墨汁流入到圖9(a)所示的以三仙膠水溶液充填的液體室時,如圖9(b)所示,墨汁不會形成靠液體室側面內周的液流,而是產生從液體流入口直接流向液體流出口的液流(短路徑)。亦即,在液體室中,墨汁不會流到偏離液體流入口及液體流出口的地點。 As a result of the test, when the ink flows into the liquid chamber filled with the aqueous solution of Sanxian gum as shown in FIG. 9(a), as shown in FIG. 9(b), the ink does not form a liquid flow by the inner circumference of the side surface of the liquid chamber, and It is a flow (short path) that produces a direct flow from the liquid inlet to the liquid outlet. That is, in the liquid chamber, the ink does not flow to a position deviating from the liquid inflow port and the liquid outflow port.

從以上結果可知,藉由將連通血液循環回路與液體室的液體流入口接頭及液體流出口接頭以錐台狀設置到液體室,不會產生短路徑,得以改善血液在液體室內的滯留,結果,可以獲致血液的凝固抑制。 From the above results, it is understood that the liquid inflow port and the liquid outflow port connecting the blood circulation circuit and the liquid chamber are arranged in a frustum shape to the liquid chamber, and a short path is not generated, thereby improving the retention of blood in the liquid chamber. , can achieve blood coagulation inhibition.

(實施例2) (Example 2)

接著,就圖6所示的液體流入口的液體室圓周方向的口徑A改變時的功效進行確認。 Next, the effect at the time of changing the diameter A in the circumferential direction of the liquid chamber of the liquid inlet shown in FIG. 6 was confirmed.

1)關於本實施例,係使用藉由電腦模擬所得的結果,就液體室流速分布進行比較。另外,每個實施例的液體室內流速分布的標準偏差係揭示於表1。 1) With respect to the present embodiment, the liquid chamber flow velocity distribution was compared using the results obtained by computer simulation. In addition, the standard deviation of the flow velocity distribution in the liquid chamber of each of the examples is disclosed in Table 1.

電腦模擬係使用IDAJ股份有限公司的流體解析軟體「STAR-CD」來進行。另外,關於本模擬模型,因為不進行壓力評估,故只將液體室模型化,並將液體流入口的液體室圓周方向口徑A設定為液體室圓周長的8.3%,且在此基礎上,採用的模型流量設為30ml/分鐘,從液體流入口流入液體室,並從液體流出口排出。 The computer simulation was performed using the fluid analysis software "STAR-CD" of IDAJ Co., Ltd. In addition, with this simulation model, since the pressure evaluation is not performed, only the liquid chamber is modeled, and the liquid chamber circumferential direction diameter A of the liquid inflow port is set to 8.3% of the liquid chamber circumference length, and on this basis, The flow rate of the model was set to 30 ml/min, which flowed into the liquid chamber from the liquid inflow port and was discharged from the liquid outflow port.

模擬結果,如表1所示,液體室內流速分布的標準偏差為0.004903(m/秒)。 As a result of the simulation, as shown in Table 1, the standard deviation of the flow velocity distribution in the liquid chamber was 0.004903 (m/sec).

(實施例3) (Example 3)

接著,就將液體流入口的液體室圓周方向口徑A設為液體室圓周長的16.7%的功效加以確認。模擬結果如表1所示,液體室的流速分布的標準偏差為0.003468(m/秒)。 Next, the effect of the liquid chamber circumferential direction diameter A of the liquid inflow port being 16.7% of the liquid chamber circumference length was confirmed. The simulation results are shown in Table 1. The standard deviation of the flow velocity distribution of the liquid chamber was 0.003468 (m/sec).

(實施例4) (Example 4)

接著,就將液體流入口的液體室圓周方向口徑A設為 液體室圓周長的25%的功效加以確認。模擬結果如表1所示,液體室流速分布中的標準偏差為0.002608(m/秒)。 Next, the liquid chamber circumferential direction diameter A of the liquid inflow port is set to The effect of 25% of the circumference of the liquid chamber was confirmed. The simulation results are shown in Table 1. The standard deviation in the liquid chamber flow velocity distribution was 0.002608 (m/sec).

(比較例2) (Comparative Example 2)

另一方面,使用圖10所示結構的壓力檢出體作為比較例2,並以下述方法進行流動狀態的確認。液體室係與實施例1相同尺寸,且採用不透過錐台狀的液體流入口接頭及液體流出口接頭,而使用內徑3.0mm左右的體外循環回路直接連接在液體流入口及液體流出口的構成,而且,設成液體流入口及液體流出口夾介著液體室相對配置的結構。將該設計作成模型,使用與實施例2至4同樣的方法,從液體流入口流入液體室,並從液體流出口排出,以確認液體室的流速分布。 On the other hand, a pressure-detecting body having the structure shown in Fig. 10 was used as Comparative Example 2, and the flow state was confirmed by the following method. The liquid chamber is the same size as in the first embodiment, and the liquid inflow port joint and the liquid outflow port joint which do not transmit through the truncated cone shape are used, and the extracorporeal circulation circuit having an inner diameter of about 3.0 mm is directly connected to the liquid inflow port and the liquid outflow port. In addition, the liquid inflow port and the liquid outflow port are arranged so that the liquid chambers are arranged to face each other. This design was modeled and flowed into the liquid chamber from the liquid inflow port by the same method as in Examples 2 to 4, and discharged from the liquid outflow port to confirm the flow velocity distribution of the liquid chamber.

模擬結果如表1所示,比較例2的液體室流速分布的標準偏差為0.007163(m/秒)。從以上可知,透過將液體流入口接頭及液體流出口接頭設為錐台狀,液體室流速分布(速度不均程度)可以縮小。 The simulation results are shown in Table 1. The standard deviation of the liquid chamber flow velocity distribution of Comparative Example 2 was 0.007163 (m/sec). As described above, by setting the liquid inflow port joint and the liquid outflow port joint to a truncated cone shape, the liquid chamber flow velocity distribution (degree of speed unevenness) can be reduced.

(比較例3) (Comparative Example 3)

接著,製作具有圖8所示結構的模型,利用與實施例2至4同樣的方法,確認了液體室的流速分布。模擬結果如表1所示,液體室流速分布的標準偏差為0.003967(m/秒)。 Next, a mold having the structure shown in Fig. 8 was produced, and the flow velocity distribution of the liquid chamber was confirmed by the same method as in Examples 2 to 4. The simulation results are shown in Table 1. The standard deviation of the liquid chamber flow velocity distribution was 0.003967 (m/sec).

從實施例2至4獲得的結果所導出的液體室流速分布的標準偏差與液體流入口的液體室圓周方向口徑與液體室圓周長比例的關係,如將液體室流速分布的標準偏差設為Y,液體流入口的液體室圓周方向口徑與液體 室圓周長的比例設為X時,則XY的關係可用下式2來表示。 The standard deviation of the liquid chamber flow velocity distribution derived from the results obtained in Examples 2 to 4 is related to the ratio of the circumferential direction of the liquid chamber in the liquid flow inlet to the circumferential length of the liquid chamber, such as setting the standard deviation of the liquid chamber flow velocity distribution to Y. , liquid chamber inlet liquid chamber circumferential direction caliber and liquid When the ratio of the circumference of the chamber is set to X, the relationship of XY can be expressed by the following formula 2.

Y=0.0311X2-0.0243X+0.0067‧‧‧(式2) Y=0.0311X 2 -0.0243X+0.0067‧‧‧(Form 2)

從式2可知,若將液體流入口的液體室圓周方向口徑A設為液體室圓周長的13.9%,則液體室流速分布的標準偏差會小於比較例2,所以透過將液體流入口的液體室圓周方向的口徑A設為液體室圓周長的13.9%以上,可獲得更佳的功效。 It can be seen from Equation 2 that if the liquid chamber circumferential direction diameter A of the liquid inflow port is set to 13.9% of the liquid chamber circumference length, the standard deviation of the liquid chamber flow velocity distribution is smaller than that of Comparative Example 2, so that the liquid chamber that passes the liquid inflow port is passed. The diameter A in the circumferential direction is set to be 13.9% or more of the circumference of the liquid chamber, and a better effect can be obtained.

依此方式,藉由將液體流入口的液體室圓周方向的口徑A設為液體室圓周長的13.9%以上50%以下,不僅可改善血液滯留而不會發生短路徑,也可以抑制流速分布的標準偏差而減少血流的紊亂,進而可抑制血液的凝固。 In this manner, by setting the diameter A in the circumferential direction of the liquid chamber of the liquid inflow port to be 13.9% or more and 50% or less of the circumference of the liquid chamber, not only the blood retention can be improved, but also the short path can be prevented, and the flow velocity distribution can be suppressed. The standard deviation reduces the disorder of blood flow, which in turn inhibits blood coagulation.

[產業上之可利用性] [Industrial availability]

本發明的壓力檢出體及具備此壓力檢出體的血液回路及血液淨化裝置,相較於習知的壓力檢出體,更能抑制血液凝固。因此,可安全的測量體外循環回路內的壓力,可使用在體外循環治療,甚為實用。 The pressure detecting body of the present invention and the blood circuit and blood purification device including the pressure detecting body can suppress blood coagulation more than the conventional pressure detecting body. Therefore, it is safe to measure the pressure in the extracorporeal circuit and can be used in extracorporeal circulation therapy.

1‧‧‧壓力檢出體 1‧‧‧Pressure detection body

5‧‧‧液體室 5‧‧‧Liquid room

6‧‧‧壓力測量裝置 6‧‧‧ Pressure measuring device

7‧‧‧空氣室 7‧‧ Air Room

8‧‧‧變形面 8‧‧‧ deformed surface

9‧‧‧室構件 9‧‧‧ room components

10‧‧‧液體流入口接頭 10‧‧‧Liquid flow inlet fittings

11‧‧‧液體流出口接頭 11‧‧‧Liquid outlet connector

12‧‧‧液體室內側隅部 12‧‧‧Liquid indoor side crotch

13‧‧‧液體室內側隅部 13‧‧‧Liquid indoor side crotch

14‧‧‧液體室內側隅部 14‧‧‧Liquid indoor side crotch

Claims (8)

一種體外循環回路用壓力檢出體,係用以測量執行血液體外處理的體外循環回路內之壓力,具備:室構件,具有會因前述體外循環回路內的壓力而變形的變形面、以及液體流入口及液體流出口,且具備供前述血液流入及排出的液體室;液體流入口接頭,用以藉管子使前述液體流入口與前述體外循環回路連通;液體流出口接頭,用以藉管子使前述液體流出口與前述體外循環回路連通;而前述液體流入口接頭及前述液體流出口接頭內部的流路係朝向前述液體室方向擴開成錐台狀。 A pressure detecting body for an extracorporeal circulation circuit for measuring a pressure in an extracorporeal circuit for performing extracorporeal treatment of blood, comprising: a chamber member having a deformed surface deformed by pressure in the extracorporeal circuit, and a liquid flow An inlet and a liquid outlet, and a liquid chamber for inflow and discharge of the blood; a liquid inflow joint for communicating the liquid inlet with the extracorporeal circuit by means of a tube; and a liquid outflow joint for using the tube The liquid outflow port is in communication with the extracorporeal circulation circuit; and the liquid inflow port joint and the flow path inside the liquid outflow port joint are expanded into a truncated cone shape toward the liquid chamber. 如請求項1之體外循環回路用壓力檢出體,其中,前述液體室係為圓柱形,前述液體流入口及前述液體流出口係配置在前述液體室的圓柱側面。 The pressure detecting body for an extracorporeal circuit according to claim 1, wherein the liquid chamber has a cylindrical shape, and the liquid inflow port and the liquid outflow port are disposed on a cylindrical side surface of the liquid chamber. 如請求項2之體外循環回路用壓力檢出體,其中,前述液體流入口的圓周方向口徑係為前述液體室圓周長的13.9%以上50%以下。 The pressure detecting body for an extracorporeal circuit according to claim 2, wherein the circumferential direction of the liquid inflow port is 13.9% or more and 50% or less of the circumferential length of the liquid chamber. 如請求項1至3中任一項之體外循環回路用壓力檢出體,其中,前述液體流入口及前述液體流出口係夾介著前述液體室相對向配置。 The pressure detecting body for an extracorporeal circulation circuit according to any one of claims 1 to 3, wherein the liquid inflow port and the liquid outflow port are disposed to face each other with respect to the liquid chamber. 如請求項1至4中任一項之體外循環回路用壓力檢出體,其中,前述液體流入口接頭及前述液體流出口接頭的形狀係為錐台狀,且以前述錐台狀的較大底面來和 前述液體室連結。 The pressure detecting body for an extracorporeal circuit according to any one of claims 1 to 4, wherein the liquid inflow port joint and the liquid outflow port joint have a truncated cone shape and are larger in the shape of the truncated cone. Bottom surface and The liquid chamber is connected. 如請求項1至5中任一項之體外循環回路用壓力檢出體,其中,前述液體流入口接頭及前述流出口接頭的內部流路係為同一形狀。 The pressure detecting body for an extracorporeal circuit according to any one of claims 1 to 5, wherein the liquid flow inlet joint and the inner flow path of the outlet joint have the same shape. 一種血液回路,係具備:如請求項1至6中任一項之體外循環回路用壓力檢出體;及體外循環回路。 A blood circuit comprising: a pressure detecting body for an extracorporeal circulation circuit according to any one of claims 1 to 6; and an extracorporeal circulation circuit. 一種血液淨化裝置,係具備如請求項7之血液回路。 A blood purification device comprising the blood circuit of claim 7.
TW103104665A 2013-02-15 2014-02-13 Pressure detector, blood circuit and blood purification apparatus with pressure detector TW201440824A (en)

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JP6550714B2 (en) * 2014-10-14 2019-07-31 ニプロ株式会社 Blood circuit with pressure measuring part
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JP2008051663A (en) * 2006-08-24 2008-03-06 Asahi Kasei Kuraray Medical Co Ltd Pressure sensor
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