Indwelling needle and medical device management system

Abstract

This invention provides an indwelling needle and medical device management system that shortens dialysis time and improves patient convenience in dialysis using a single-needle type indwelling needle. [Solution] The indwelling needle 100 has a needle portion 200 having a hollow cross-section channel (needle channel portion) and a partition plate 300 inserted into the inside of the channel (needle channel portion) of the needle portion. The needle portion has a needle body 210 provided on the front side and inserted into the blood vessel, and a needle base portion (needle bottom portion 220) provided on the rear side of the needle body 210. The partition plate is inserted in place of the puncture needle after the needle portion has been punctured into the blood vessel together with the puncture needle 900, thereby dividing the hollow cross-section channel (needle channel portion) of the needle portion into a channel for the blood withdrawal portion 250 and a channel for the blood return portion.

Description

[Technical Field]

[0001] The present invention relates primarily to an indwelling needle used when inserted into a blood vessel for the purpose of blood purification therapy (also known as "dialysis therapy" or "dialysis"), and to a medical device management system for managing such an indwelling needle. [Background technology]

[0002] A single-needle indwelling needle, used when inserted into a blood vessel for purposes such as blood purification therapy, has a double-tube structure, consisting of, for example, an outer tube that serves as a tube for drawing blood from the blood vessel to the outside of the body, and an inner tube that returns the purified blood, which has been passed through a dialysis machine (filtration device (dialyzer)) after being drawn from the body, back into the body (see, for example, Patent Documents 1 and 2).

[0003] In the technology described in Patent Document 1, the outer tube is a conduit of a hub into which an injection needle used to puncture a blood vessel is inserted for insertion of the outer tube into the blood vessel, and the inner tube is a metal tube of a biaxial flow device connected to the base of the hub. In this example, blood in the blood vessel is drawn into the conduit through the gap between the conduit and the metal tube, then passes through a branching point and is led to the dialysis machine through a tube that is a blood discharge port. The purified blood passes through a tube that is a blood return port at the base of the biaxial flow device, through the metal tube, and is returned to the blood vessel.

[0004] Patent Document 2 proposes a technology that solves the conventional problems. Specifically, by making the hollow cross-section of the inner tube semi-cylindrical, it is made easier to generate convection in the blood as it passes through the discharge tube and return tube, making it easier to distribute the pressure inside the discharge tube and return tube, and eliminating the weakness in strength due to the internal pressure of the discharge tube and return tube. Furthermore, by making the hollow cross-section of the inner tube crescent-shaped (U-shaped), a technology is proposed that makes it easier to set the cross-sectional area perpendicular to the axis of the inner tube to be equal to the cross-sectional area perpendicular to the axis of the outer tube. In this technology, the crescent-shaped (U-shaped), or concave, portion between the inner tube and the outer tube can facilitate the intake or discharge of blood, making it easier to increase the blood flow rate and reduce the burden on the patient. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Special Publication No. 60-27538 [Patent Document 2] Patent No. 6933386 [Overview of the project] [Problems that the invention aims to solve]

[0006] Incidentally, the technology described in Patent Document 2 makes it possible to increase the blood flow rate through the indwelling needle, thus shortening dialysis time. On the other hand, there has always been a demand for shorter dialysis times and improved patient convenience, so new technologies have been needed.

[0007] This invention has been made in view of the above circumstances, and aims to provide a technology that shortens dialysis time and improves patient convenience in dialysis using a single-needle type indwelling needle. [Means for solving the problem]

[0008] The present invention provides the following technology. Technology 1: An indwelling needle (100) comprising: a blood withdrawal section (250) inserted into a blood vessel to withdraw blood from the blood vessel and discharge it outside the blood vessel; and a blood return section (260) inserted into the blood vessel and integrally combined with the blood withdrawal section (250) to return the blood that has been withdrawn from the blood vessel back into the blood vessel, A needle portion (200) having a hollow channel (201) in cross-section, A partition plate (300) is inserted into the flow path (201) of the needle portion (200), It has, The needle portion (200) is A needle body (210) provided on the anterior side and inserted into the blood vessel, A needle base (needle bottom portion 220) is provided on the rear side of the needle body (210), It has, The partition plate (300) is inserted in place of the puncture needle (900) after the needle portion (200) has been punctured into a blood vessel together with the puncture needle (900), thereby dividing the hollow channel (201) of the needle portion (200) into two channels: the channel for the blood withdrawal portion (250) and the channel for the blood return portion (260). Indwelling needle (100). Technology 2: The aforementioned needle base (needle bottom portion 220) is The blood drainage opening (first opening (231)) connects the flow path of the blood drainage section (250) to the outside, The flow path of the blood return section (260) is connected to the outside by a dialysis blood return opening (232), It has, The main body portion (400) houses the needle base portion (needle bottom portion 220) of the needle portion (200), and when the partition plate (300) is inserted into the needle portion (200), the partition plate (300) is inserted before the needle portion (200), The main body (400) has a bottomed cylindrical housing (401), The housing portion (401), with the needle base (needle bottom portion 220) housed within it, has a first connecting portion (410) that communicates with the blood withdrawal opening (first opening (231), blood withdrawal side) and a second connecting portion (410) that communicates with the dialysis blood return opening (second opening (232), blood return side). The first connecting portion (410) is connected to an external first hose (911), and the second connecting portion (420) is connected to an external second hose (912). The indwelling needle (100) described in Technical 1. Technology 3: The inner diameter of the flow path exhibited by the needle body (210) of the needle portion (needle portion 200) is such that the size of the inner diameter at a certain position in the extending direction of the needle body (210) is greater than or equal to the size of the inner diameter towards the tip from that position, and at least a portion of it has an inner diameter widening section that gradually widens from the tip side (front side) to the base side (rear side). The widened inner diameter portion has a tapered shape in a region of 80% or more of the length of the needle body (210). Indwelling needle (100) according to Technical Reference 2, wherein the taper ratio of the tapered shape is 1% or more and 3% or less within the effective length of the subcutaneous insertion range in the widened inner diameter portion. technology 4 The portion of the partition plate (300) that is housed in the needle body (210) is provided at a position that, when housed in the needle body (210), becomes the largest inner diameter in the cross-section of the flow path presented by the needle body (210), as described in any one of the 1 to 3 technologies. Technique 5: The portion of the partition plate (300) that is housed in the needle body (210) is provided at a position offset from the center of the cross-section of the flow path presented by the needle body (210) when housed in the needle body (210), as described in any one of the 1 to 3 articulations for indwelling needle (100). Technology 6: The indwelling needle (100) according to Technical Reference 2, wherein the needle portion (200) and the main body portion (400) are configured to be connected and separated multiple times. Technique 7: The partition plate (300), while housed in the needle body (210), is positioned so as to be offset from the center of the flow path cross-section toward the flow path side of the blood return section (260). In the needle portion (200), the cross-sectional area of ​​the flow path of the blood withdrawal portion (250) is wider than the cross-sectional area of ​​the flow path of the blood return portion (260), as described in Technical Reference 5. Technology 8 <Slits>: The tip of the needle portion (200) has, in a state where the blood withdrawal portion (250) and the blood return portion (260) are separated by the partition plate, a blood withdrawal side slit (221) that connects the blood withdrawal portion (250) to the outside, and a blood return side slit (222) that connects the blood return portion (260) to the outside. The blood withdrawal slit (221) is positioned forward of the blood return slit (222) with respect to the extension direction of the needle portion (200). The indwelling needle (100) according to Technology 1, wherein the blood withdrawal side slit (221) and the blood return side slit (222) are provided at a position within 25 mm from the tip of the needle portion (200). Technology 9 <Size of slit>: The area of the blood withdrawal side slit (221) is not less than the cross-sectional area at the tip of the blood withdrawal side flow path, The indwelling needle (100) according to Technology 1, wherein the area of the blood return side slit (222) is not less than the cross-sectional area at the tip of the blood return side flow path. Technology 10: The main body portion (400) When any one of the puncture needle (900) and the partition plate (300) is selected and inserted into the needle portion (200), it has a fixed connection portion (430) for fixing the inserted member, When the puncture needle (900) or the partition plate (300) is fixed to the fixed connection portion (430), it has a hemostatic valve (500) for ensuring liquid tightness between the inside (accommodation portion 401) and the outside of the main body portion (400). The indwelling needle (100) according to Technology 2 or 3, wherein the hemostatic valve (500) is detachable from the main body portion (400). Technology 11: The partition plate (300) is connected to the rear of the main body portion (400) in a state where the partition plate (300) is inserted into the partition plate insert (305), and is configured to pass through the hemostatic valve (500). The tip portion of the partition plate insert (305) is configured to be inserted and stopped in a state where it passes through the hemostatic valve (500) and is exposed on the opposite side. In this state, the partition plate (300) is sent out from the opening at the tip of the partition plate insert (305) and arranged inside the flow path of the needle portion (200). The indwelling needle (100) according to Technology 10. Technology 12: The partition plate insert (305) is separable from the partition plate (300) in a state where the partition plate (300) is arranged in the needle portion (200), and is configured to be removable from the main body portion (400) after being separated from the partition plate (300). The indwelling needle (100) according to Technology 11. Technology 13: A sheath introducer (1200) is inserted into the blood vessel, It has a partition plate body (1301), and a blood withdrawal function unit (1300) attached to the sheath introducer (1200) such that the partition plate body (1301) is inserted into the interior of the sheath introducer (1200), The sheath introducer (1200) and the blood withdrawal function unit (1300) are detachable. The aforementioned sheath introducer (1200) The sheath body (1210), which is a hollow tube inserted into the blood vessel from the tip, A sheath base (1220) is provided on the rear side of the sheath body (1210) and has a first connecting channel (1270) that connects to the blood draining function section (1300), It has, The aforementioned sheath base (1220) is A blood return hose connection part (1280) to which the blood return hose (1402) connected to the dialysis machine is connected, A second connecting channel (1281) is in communication with the blood return hose connection (1280) and connects to the tube of the sheath body (1210), The partition plate insertion portion (1270) through which the partition plate body (1301) is inserted, A hemostatic valve (500) is provided on the rear side of the partition plate insertion portion, It has, The aforementioned blood draining function unit (1300) is The partition plate body (1301) and, The blood drainage base (1302) is provided at the rear end of the partition plate body (1301), It has, The base of the blood withdrawal portion (1302) is, The blood withdrawal hose connection part (1380) to which the blood withdrawal hose (1401) that leads to the dialysis machine is connected, A third connecting channel (1370) is in communication with the blood withdrawal hose connection (1380) and has an opening near the extension source of the partition plate body (1301), It has, The sheath introducer (1200) is inserted into a blood vessel with a puncture needle inserted through the partition plate insertion portion (1270) and the hemostatic valve (500), and then, after the puncture needle is removed and the partition plate body (1301) is attached in place of the puncture needle, the partition plate body (1301) is inserted through the partition plate insertion portion (1270) and the hemostatic valve (500) into the sheath body (needle body 121 An indwelling needle (1100) inserted into the tube of (0), in which state the partition plate body (1301) divides the inside of the tube into two channels, a blood withdrawal channel (1251) and a blood return channel (1261), the blood withdrawal channel (1251) is connected to the first connecting channel (1270), the first connecting channel (1270) is connected to the third connecting channel (1370), and the blood return channel (1261) is connected to the second connecting channel (1281). Technology 14: The indwelling needle (1100) according to Technical Reference 13, wherein the sheath introducer (1200) is attached to the blood withdrawal function unit (1300), and the tip of the partition plate body (1301) has a tip tube portion (1350) that protrudes by a predetermined length from the tip of the sheath body (needle body 1210) and communicates the blood withdrawal side flow path (1251) with the inside of the blood vessel. Technology 15: The tip portion (1350) has the blood withdrawal side slit (1371), The sheath body (needle body 1210), when partitioned by the partition plate body (1301) into the blood withdrawal side channel (1251) and the blood return side channel (1261), has a blood return side slit (1272) that connects the blood return side channel (1261) to the outside, The blood withdrawal slit (1371) is positioned forward of the blood return slit (1272) with respect to the extension direction of the sheath body (needle body 1210). The indwelling needle (1100) described in Technical 13. Technology 16: The sheath body (needle body 3210), when partitioned by the partition plate body (3301) into the blood withdrawal side channel (3251) and the blood return side channel (3261), has a blood withdrawal side slit (3271) that connects the blood withdrawal side channel (1251) to the outside, and a blood return side slit (3272) that connects the blood return side channel (3261) to the outside. The blood withdrawal slit (3271) is positioned forward of the blood return slit (3272) with respect to the extension direction of the sheath body (needle body 1210). The indwelling needle (3100) described in Technical 13. Technology 17: The indwelling needle (1100) described in Technical Reference 16, wherein the blood return slits (1272, 3272) are located within 20 mm from the tip of the sheath body (1210, 3210). Technology 18: The indwelling needle according to Technology 1, further comprising an IC tag (RFID 82, 83, 84, 89) provided on at least one of the needle body (200), the needle base (400), or the partition plate (300). Technology 19 technology: A reader / writer (55, 85) that reads and writes information from the IC tags (RFID 82, 83, 84, 89) attached to the indwelling needle described in Technical 18, A database (51, 52) that records information about the indwelling needle and information about the patient using the indwelling needle, Based on the information from the aforementioned IC tags (RFID 82, 83, 84, 89), there is a usage management unit (20, 30, 40) that manages the use of the aforementioned dialysis indwelling needles, Equipped with, The reed / writer is attached to the indwelling needle cleaning device (86), and the medical device management system (1) reflects the cleaning history of the indwelling needle by the cleaning device in the database. Technology 20: The medical device management system (1) described in Technical Reference 19, wherein the read / writer is attached to the cleaning device for the indwelling needle, and the cleaning history of the dialysis indwelling needle by the cleaning device is reflected in the IC tags (RFID 82, 83, 84, 89). Technology 21: The lead writer is attached to a dialysis device that performs dialysis using the indwelling needle, obtains information on the IC tag (RFID82, 83, 84, 89) when performing the dialysis, and reflects the usage history of the indwelling needle in the database. The medical device management system (1) described in Technology 19. Technology 22: When the usage history of the indwelling needle is within a range suitable for reuse set in advance, the usage management unit (20, 30, 40) permits dialysis using the indwelling needle. The medical device management system (1) described in Technology 19. Technology 23: When the usage management unit (20, 30, 40) determines from the usage history and cleaning history of the indwelling needle that it has not been cleaned since the previous use, it does not permit dialysis using the indwelling needle. The medical device management system (1) described in Technology 19. Technology 24: Based on the information of the IC tag (RFID82, 83, 84, 89), it includes a supply management unit that manages the supply of the indwelling needle. The medical device management system (1) described in Technology 19. Technology 25: The medical device management system (1) described in Technology 19 has a user management unit that manages a subscription contract regarding the patient or the medical institution used by the patient and the indwelling needle for dialysis. Technology 26 <EC Management Unit>: The user management unit (20) has a settlement processing unit. The settlement processing unit performs application processing for a new contract regarding the subscription contract, settlement processing for the subscription, settlement processing with the business operator that provides the indwelling needle for dialysis sold to the patient in the subscription contract, settlement processing with the medical institution, and settlement processing with the logistics business operator that transports the indwelling needle for dialysis. The medical device management system (1) described in Technology 25. Technology 27 <Factory Material Ordering and Production Schedule>: A medical device management system (1) as described in Technical Reference 25, having a logistics management department (40) (factory management department) that manages the manufacturing (including ordering materials) and shipment (logistics) of the indwelling needles provided to users (patients) who have entered into the subscription contract, based on the usage history and cleaning history of the indwelling needles and the contract information relating to the subscription contract managed by the user management department. Technology 28: Mechanism for supplying materials for medical devices and pharmaceuticals: The aforementioned Logistics Management Department (40) (Factory Management Department) A medical device management system (1) as described in Technology 27, which, based on the usage history and cleaning history of the indwelling needle and the contract information relating to the subscription contract managed by the user management unit, notifies the user who has a subscription contract of the date on which the indwelling needle will be provided and the logistics company (logistics business or delivery company) of the user's shipping destination, the date on which the provision will be provided, the quantity to be requested from the logistics company, and the schedule for collection and dispatch of the indwelling needle to the factory or shipping facility via a network. [Effects of the Invention]

[0009] According to the present invention, in dialysis using a single-needle type indwelling needle, the dialysis time can be shortened and patient convenience can be improved. [Brief explanation of the drawing]

[0010] [Figure 1] This figure illustrates an example of the use of an indwelling needle according to this embodiment. [Figure 2] This is a magnified view of the portion of the indwelling needle inserted into a blood vessel according to this embodiment. [Figure 3] This is a four-view drawing of an indwelling needle according to this embodiment. [Figure 4] This diagram shows the indwelling needle in an exploded state, with the needle portion, main body portion, partition plate, and puncture needle components being the constituent parts of this embodiment. [Figure 5] This is a cross-sectional view illustrating the internal structure of an indwelling needle according to this embodiment. [Figure 6] This is a five-view drawing of the needle portion according to this embodiment. [Figure 7] This is a five-view drawing of the main body according to this embodiment. [Figure 8] This is a four-view drawing of the partition plate according to this embodiment. [Figure 9] This is a cross-sectional view showing the internal structure of the needle section partitioned by a partition plate according to this embodiment. [Figure 10] These are four-view views of a modified partition plate according to this embodiment. [Figure 11] This is a cross-sectional view showing the internal structure of the needle portion partitioned by a modified partition plate according to this embodiment. [Figure 12] This figure illustrates various sizes (outer diameter, inner diameter, outer area, inner area) of the effective length L region of the needle body according to this embodiment. [Figure 13] This figure shows a modified example of an indwelling needle according to this embodiment. [Figure 14] This figure shows an example of the use of a modified indwelling needle according to this embodiment. [Figure 15] This is a three-view drawing of a modified puncture needle according to this embodiment. [Figure 16] This is a three-view drawing of a modified needle portion according to this embodiment. [Figure 17] This is a three-view drawing of a modified blood drainage function unit according to this embodiment. [Figure 18] This is a cross-sectional view of a modified example of this embodiment showing the connection between the needle portion and the blood-draining function portion. [Figure 19] This figure shows a modified example of an indwelling needle according to this embodiment. [Figure 20] This is a two-view drawing of the needle portion according to this embodiment. [Figure 21] This is a two-view drawing of the blood drainage function unit according to this embodiment. [Figure 22] This figure shows the cross-sectional structure and the change in inner diameter (radius) of a commonly used indwelling needle (a separate needle for blood withdrawal and blood return) according to this embodiment. [Figure 23] This figure shows the cross-sectional structure and the change in inner diameter (radius) of a commonly used indwelling needle (a separate needle for blood withdrawal and blood return) according to this embodiment. [Figure 24] This figure shows the change in the size of the flow path inside the indwelling needle according to this embodiment. [Figure 25] This figure illustrates the cause of high resistance occurring in the flow path according to this embodiment. [Figure 26] This figure illustrates the cause of high resistance occurring in the flow path according to this embodiment. [Figure 27] This figure shows variations in the shape of the slits (first slit and second slit) according to this embodiment. [Figure 28] This figure shows the first and second slits of Modification 1 according to this embodiment. [Figure 29] This figure shows the first and second slits of a modified example 2 according to this embodiment. [Figure 30] This figure illustrates the taper ratio according to this embodiment. [Figure 31] This figure illustrates the taper ratio according to this embodiment. [Figure 32] This diagram illustrates the overview of the delivery management of dialysis medical devices to dialysis patients using a medical device management system according to this embodiment. [Figure 33] This diagram illustrates the overview of the delivery management of dialysis medical devices to dialysis patients using a medical device management system according to this embodiment. [Figure 34] This is a block diagram showing the schematic configuration of a medical device management system according to this embodiment. [Figure 35] This figure shows an example of user information (patient information) recorded in the user database according to this embodiment. [Figure 36] This figure shows an example of medical device information recorded in the medical device database according to this embodiment. [Figure 37] This is a flowchart illustrating an example of the delivery process for dialysis indwelling needles according to this embodiment. [Figure 38] This flowchart shows an example of the process of reading / writing the usage history of a dialysis indwelling needle using RFID according to this embodiment. [Figure 39]This flowchart shows an example of the process of reading / writing the cleaning history of a dialysis indwelling needle using RFID according to this embodiment. [Modes for carrying out the invention]

[0011] Embodiments of the present invention will be described with reference to the drawings. The following technologies provide indwelling needles and new treatment systems using such needles, thereby improving the usage cycle of indwelling needles, reducing the amount of discarded needles, and enabling an optimized supply system and treatment system for indwelling needles. Furthermore, the technology provides a single-needle type indwelling needle that is effective in shunt vessels. Focusing on patients who use indwelling needles inserted into the arteries and veins of the arm, patients undergoing blood purification therapy (dialysis) in Japan receive treatment every other day. Each procedure involves two needles being used to puncture two locations in the arm. Six punctures are performed in the arm over a week, and the same puncture sites are used again a week later. This means that patients undergo four punctures in the same area of ​​their arm per month, damaging the skin and blood vessels of their arm, making it difficult for them to heal from the punctures. Patients who require blood purification therapy must undergo procedures such as artificial blood vessel insertion or buttonhole insertion to recover from the tears in the skin and blood vessels of their arm, and continue with the treatment. Herein lies a need for technology to improve the indwelling needle usage cycle to prevent tears in the skin and blood vessels of the arm. Furthermore, as many as 30 indwelling needles are discarded per month by a single patient. This means that 360 indwelling needles are used and discarded per year, 1800 per five years, and 3600 per ten years by a single patient. There is a need for technology to improve the disposal cycle of indwelling needles consumed and discarded by a single patient. In addition, medical institutions need technology to manage the procurement and disposal cycle of indwelling needles. The following proposes technologies to solve these problems.

[0012] Conventionally, single-needle type indwelling needles have been known that form two channels with a single outer tube. For example, two channels are formed: a donut-shaped channel with a small inner tube inserted into a large outer tube, and a circular channel with a small inner tube. With such indwelling needles, inserting the small inner tube into the large outer tube prevents the pressure within the channels from being reduced, causing blood turbulence and making it difficult to achieve the desired blood flow rate. Furthermore, the outer diameter of the outer tube becomes large, making hemostasis difficult, which has made them impractical for use in the field.

[0013] The inventors of the present invention proposed a cost-conscious indwelling needle by applying the technology of Patent No. 6933386 (hereinafter referred to as Technology 1), which forms two flow paths using a sheath introducer consisting of an outer cylinder and an inner cylinder. In the present invention, instead of the inner cylinder of Technology 1, an indwelling needle is proposed in which the inside of the outer cylinder is divided into two by inserting a plate-shaped partition plate through the outer cylinder, thereby forming two flow paths. For example, by installing a partition plate in the inner diameter cross-sectional area of ​​a 16G indwelling needle, it is possible to substantially form two indwelling needles with a cross-sectional area equivalent to 18G. Furthermore, for example, in the case of a 15G indwelling needle, one indwelling needle with performance equivalent to two 17G indwelling needles is constructed, and hemodialysis can be performed by puncturing the shunt with this single indwelling needle.

[0014] This section briefly explains the differences between the dialysis method proposed in this embodiment and the generally practiced dialysis method. In current general hemodialysis, a shunt is used, which involves suturing a vein to an artery to connect them and directly drain arterial blood into the vein. In this method, dialysis is performed by inserting an indwelling needle using two locations: a high shunt blood pressure (40-100 mmHg) at the shunt site closer to the artery, and a low shunt blood pressure (10-40 mmHg) at the shunt site closer to the vein. The indwelling needle in this embodiment achieves blood withdrawal and return using the same shunt blood pressure by puncturing only one location at the shunt site.

[0015] Below, we will first describe the indwelling needle 100 with reference to Figures 1 to 31. Next, we will describe the management technology (medical device management system 1) for the indwelling needle 100 with reference to Figures 32 to 39.

[0016] <Indwelling needle> Figure 1 illustrates an example of the use of the indwelling needle 100 in this embodiment. Figure 2 is a magnified view of the needle portion 200. Figure 2(a) is a magnified view of the portion inserted into the blood vessel in Figure 1(d), and Figure 2(b) is a cross-sectional view of the needle portion 200. Figure 3 is a four-view drawing of the indwelling needle 100, where Figure 3(a) is a side view, Figure 3(b) is a top view, Figure 3(c) is a front view, and Figure 3(d) is a rear view. Figure 4 is a diagram showing the components of the indwelling needle 100, including the needle portion 200, the main body portion 400, the partition plate 300, and the puncture needle 900, in an exploded view. Figure 5 is a cross-sectional view (Y1-Y1 cross-sectional view in Figure 3) illustrating the internal structure of the indwelling needle 100. Figure 6 is a five-view drawing of the needle portion 200, where Figure 6(a) is a side view, Figure 6(b) is a top view, Figure 6(c) is a front view, Figure 6(d) is a rear view, and Figure 6(e) is a cross-sectional view. Figure 7 is a five-view drawing of the main body 400, where Figure 7(a) is a side view, Figure 7(b) is a top view, Figure 7(c) is a front view, Figure 7(d) is a rear view, and Figure 7(e) is a cross-sectional view (X2-X2 cross-sectional view of Figure 7(a)). Figure 8 shows four views of the partition plate 300, where Figure 8(a) is a side view, Figure 8(b) is a top view, Figure 8(c) is a front view, and Figure 8(d) is a rear view. Figure 9 is a cross-sectional view showing the internal structure of the needle section 200 partitioned by the partition plate 300, and is the X1-X1 cross-sectional view in Figure 3. Figure 9(a) shows the state with the partition plate 300 removed, and Figure 9(b) shows the state with the partition plate 300 installed. Figure 10 is a four-view drawing of a modified partition plate 300, where Figure 10(a) is a side view, Figure 10(b) is a top view, Figure 10(c) is a front view, and Figure 10(d) is a rear view. Figure 11 is a cross-sectional view showing the internal structure of the needle section 200 partitioned by the modified partition plate 300, and corresponds to Figure 9. Figure 11(a) shows the state with the partition plate 300 removed, and Figure 11(b) shows the state with the partition plate 300 installed. In this embodiment, the side of the indwelling needle 100 that is punctured into the blood vessel is described as the anterior side (or anterior direction), and the opposite side is described as the posterior side (or posterior direction), with arrows in Figure 5 indicating the anterior and posterior directions. Also, when the indwelling needle 100 is punctured into the blood vessel, the blood withdrawal section 250 is on the anterior side and the blood return section 260 is on the posterior side.

[0017] <Overview and usage examples of indwelling needles> The structure and usage examples of the indwelling needle 100 will be explained using Figures 1 and 2. As shown in Figure 1(a), a needle body unit in which the needle part 200 and the main body part 400 are integrated, and a puncture needle 900 are prepared.

[0018] Next, as shown in Figure 1(b), the puncture needle 900 is inserted from the rear side (right side in the illustration) of the needle body unit, and the tip of the puncture needle body 901 is extended a predetermined length beyond the tip of the needle body 210 to puncture the blood vessel.

[0019] Next, as shown in Figure 1(c), the puncture needle 900 is removed from the needle body unit (needle part 200 and body part 400), and the partition plate 300 attached to the cartridge 305 is inserted in place of the puncture needle 900 from the rear side (right side in the illustration) of the body part 400. After fixing the partition plate 300 in place, the cartridge 305 is removed. As a result, the internal flow path of the needle body unit 101 is divided into a blood withdrawal section 250 and a blood return section 260 by the partition plate 300.

[0020] Subsequently, as shown in Figures 1(d) and 2(a), the needle body unit (more specifically, the main body 400) is connected to the dialyzer and dialysis is performed. As shown in Figure 2(a), blood is drawn in from the first slit 221 (blood withdrawal side slit) to the blood withdrawal section 250, and the blood dialyzed by the dialyzer is returned to the blood vessels through the blood return section 260 and then through the second slit 222 (blood return side slit). The details are explained below.

[0021] <Structure of an indwelling needle> The indwelling needle 100 comprises a needle portion 200, a partition plate 300, a main body portion 400, and a puncture needle 900. The partition plate 300 and the puncture needle 900 are used selectively.

[0022] The needle portion 200 and the main body portion 400 are configured to be separable, and the needle portion 200 and the main body portion 400 are connected to assemble the needle body unit 101. With the needle portion 200 and the main body portion 400 assembled, that is, the puncture needle 900 or partition plate 300 is inserted through the fixed connection portion 430 on the rear side of the main body portion 400 and housed inside the needle body unit 101.

[0023] When the partition plate 300 is inserted into the needle body unit 101, the needle flow path section 201 (blood withdrawal section 250, blood return section 260) located inside the needle section 200 in the needle body unit 101 is connected to the first connecting section 410 and the second connecting section 420 of the main body section 400. The first connecting section 410 and the second connecting section 420 of the main body section 400 are connected to the dialysis machine via a predetermined hose (or tube), as will be described later.

[0024] Furthermore, since the needle section 200 and the main body section 400 are separable, they can be properly cleaned internally. That is, the needle section 200 and the partition plate 300 can be cleaned separately using a designated cleaning device. Also, the needle section 200 and the main body section 400 may be disposed of and the other reused. When reconnecting them after cleaning, the same needle section 200 and main body section 400 as before separation may be reconnected, or different needle sections 200 and main body sections 400 may be connected. The number of times the needle section 200 and main body section 400 can be reused can be managed, for example, by an IC tag as described later. The following explanation will focus primarily on the configuration when the partition plate 300 is inserted.

[0025] <Needle part> The needle portion 200 has a needle body 210 provided on the front side and a needle base portion 220 provided on the rear side. In this embodiment, the needle body 210 and the needle base portion 220 are integrally formed, but the needle body 210 and the needle base portion 220 may be formed as separate parts and connected, for example, by screw fitting. Alternatively, the needle body 210 and the needle base portion 220 may be manufactured as an integrally molded structure using a 3D printer or the like. This makes it possible to design flow paths that were previously difficult, especially smooth flow path designs without steps or other uneven surfaces.

[0026] The material for the needle portion 200 is not particularly limited, but for example, at least one resin selected from the group consisting of polyethylene, polypropylene, polyolefins such as ethylene-vinyl acetate copolymer, polyolefin elastomers, polyvinyl chloride, polyester, polyester elastomers, polyether nylon, polyamide, polyamide elastomers, polyurethane, polyurethane elastomers, polystyrene, polyacetal, polycarbonate, methacrylic resins such as polymethyl methacrylate, polyvinyl alcohol, polysulfone, polyimide, polyetherimide, polyethersulfone, polyetheretherketone, polybutadiene, fluororesins such as ethylene-tetrafluoroethylene, and silicone resins can be used. If multiple resins are used, two or more may be used in the form of a mixture.

[0027] As shown in Figures 5 and 6, the needle body 210 and the needle base 220 are both hollow inside, and these hollow structures connect to form the needle flow path 201. In other words, the needle flow path 201 integrally includes the body-side flow path 219 of the needle body 210 and the needle base-side flow path 229 of the needle base 220.

[0028] As will be described later, the needle base portion 220 is provided with a channel housing portion 270 that divides the rear region of the needle base side channel 229 into left and right (first needle base side channel 229a, second needle base side channel 229b). A partition plate 300 (more specifically, a base portion 302) is inserted and positioned within this channel housing portion 270. When the partition plate 300 is inserted into the needle channel portion 201 of the needle portion 200, the partition plate 300 divides the needle channel portion 201, which has a hollow cross-section, into a blood withdrawal portion 250 and a blood return portion 260.

[0029] <Needle body> The needle body 210 is a tubular portion that is inserted into the blood vessel after puncturing it, and its tip is open. The outer diameter of the needle body 210 is such that the outer diameter at a certain point in the extension direction of the needle body 210 is greater than or equal to the outer diameter towards the tip from that point. In other words, the outer diameter of the needle body 210 is tapered without any steps. However, there may be some parts that are formed straight. The same applies to the inner diameter of the needle body 210; from the viewpoint of maintaining a constant wall thickness, the inner diameter and outer diameter exhibit similar shape changes (changes in diameter). The inner diameter and outer diameter do not necessarily have to exhibit the same shape changes.

[0030] The needle body 210 can be described as the portion with the so-called effective length L (also called the "effective length of subcutaneous insertion range"; see Figure 2(a)). For convenience, the effective length L region of the needle body 210 is understood as the portion inserted into the skin (subepidermal) (the region with subcutaneous insertion length Y), and further, the region inserted into the blood vessel (the region with vascular insertion length X).

[0031] The length of the needle body 210 (i.e., the effective length L) is, for example, 30 mm to 90 mm. The lower limit of the effective length L is preferably 35 mm or more, more preferably 40 mm or more. The upper limit of the effective length L is preferably 85 mm or less, more preferably 80 mm or less.

[0032] The subcutaneous insertion length Y and vascular insertion length X ranges vary in actual procedures, but the effective length L of the needle body 210 can be used as a general guideline, for example, as follows: (A) When the effective length L = 50 mm Subcutaneous insertion length Y: 15-45mm Vascular insertion length X: 5-35mm (B) When the effective length L = 60 mm Subcutaneous insertion length Y: 25~50mm Vascular insertion length X: 15-40 mm (C) When the effective length L = 70 mm Subcutaneous insertion length Y: 30-60mm Vascular insertion length X: 20-50 mm The subcutaneous insertion length Y and vascular insertion length X mentioned above will be discussed in detail later, but they are particularly considered when a tapered shape is adopted for the needle body 210.

[0033] The needle body 210 has two slits (first slit 221, second slit 222) near its tip. The outer diameter of the tip (front side) beyond the two slits is tapered, decreasing in diameter towards the front. The tip of the needle body 210 is not limited to a tapered shape; it may have a constant diameter (outer diameter and / or inner diameter) similar to the rear side.

[0034] The inner diameter of the needle body 210 is set to be slightly larger than the outer diameter of the puncture needle body 901 of the puncture needle 900. As a result, when the puncture needle 900 is inserted into the indwelling needle 100, the puncture needle body 901 passes smoothly through the needle body 210, and its tip protrudes from the needle body 210. The structure allows the tip of the puncture needle 900 to be fixed at a position where it protrudes a predetermined length (for example, a few millimeters) from the tip of the needle body 210. In addition, since the inner diameter of the needle body 210 and the outer diameter of the puncture needle body 901 are approximately the same, the intrusion of blood into the gap between the needle body 210 and the puncture needle body 901 is minimized.

[0035] Figure 12 illustrates various sizes (outer diameter, inner diameter, outer area, inner area) of the effective length L region of the needle body 210. In this embodiment, the needle body 210 (effective length L region) has an outer diameter of, for example, 12G to 18G (2,700mm to 1,250mm), preferably 13G to 17G, and more preferably 14G to 16G. The wall thickness of the needle body 210, obtained by subtracting the inner diameter from the outer diameter, is approximately 0.2mm in the case of 16G. If the lower limit of the outer diameter falls below the above range, the inner diameter also becomes narrower, making it difficult to achieve the desired blood flow rate. If the upper limit of the outer diameter exceeds the above range, damage to blood vessels, etc., during puncture becomes greater. In other words, the settings are determined by considering the balance between the desired blood flow rate and damage to blood vessels, etc. Therefore, in order to minimize damage to blood vessels, etc., and to achieve the desired blood flow rate, it is preferable to realize a needle body 210 with a wall thickness of 0.15mm, which is thinner than 0.2mm.

[0036] The longer the portion of the needle body 210 inserted into the blood vessel, the more stable the needle becomes within the vessel. However, considering the resistance to blood flow and the impact on the blood vessel when blood flow is increased, a shorter needle is preferable. The indwelling needle 100 of this embodiment is a so-called single-needle type, and a structure that can increase the flow rate can be realized. Currently, the length of the needle body 210 used in general treatment is 35 to 40 mm. However, with the structure of this embodiment (such as the tapered shape and slit design described later), a balance can be struck between stability during vascular insertion, increased flow rate, and suppression of the impact on the blood vessel by making the needle body 210 30 to 90 mm long. Furthermore, from the perspective of realizing such a needle body 210, by appropriately adjusting the material composition of the needle portion 200 described above, a structure can be realized that is somewhat rigid and flexible, maintains a stable posture, and ensures a sufficient flow rate at the above length.

[0037] <Cross-sectional shape of the needle channel section> Figure 9 shows the X1-X1 cross-section of Figure 3(a). This cross-section represents the cross-sectional shape of the effective length L (see Figure 2) of the needle body 210, and shows the region behind the first slit 221 and the second slit 222.

[0038] As shown in the figure, the cross-section of the needle body 210 is annular (or cylindrical), and its outer and inner shapes are formed to be perfect circles. The cross-sectional shape of the needle channel section 201 may be a perfect circle or a deformed circle.

[0039] A guide portion 211 is provided on the wall surface of the needle flow path 201. The guide portion 211 is a groove formed to extend in the front-rear direction. When inserting the partition plate 300 into the needle body 210, the widthwise end face of the partition plate body 301 is fitted into the groove of the guide portion 211.

[0040] When the partition plate body 301 is inserted into the needle channel section 201, the partition plate body 301 divides the circular cross-section needle channel section 201 into two regions, namely the blood withdrawal section 250 and the blood return section 260. In this embodiment, the partition plate body 301 is positioned to divide the needle channel section 201 in two (i.e., zero offset), and the cross-sectional shapes of the blood withdrawal section 250 and the blood return section 260 are semicircles of the same size. For example, if the indwelling needle 100 is an indwelling needle equivalent to a 16G needle, it is possible to achieve a blood flow rate equivalent to that of two indwelling needles with channels equivalent to 18G needles.

[0041] Furthermore, it is not necessary to provide a guide portion 211 in the needle channel section 201. In that case, the width of the partition plate body 301 of the partition plate 300 will match the inner diameter of the needle channel section 201. Alternatively, the cross-sectional shape of the needle channel section 201 may be made non-circular, and the shape and dimensions of the partition plate body 301 may be adjusted accordingly to ensure that the partition plate body 301 can be correctly inserted into the desired position.

[0042] <Example of a partition plate being offset in position> Referring to Figures 10 and 11, a configuration in which the insertion position of the partition plate 300 is offset from the center C will be described. In this configuration, the position of the partition plate body 301 of the partition plate 300 is offset, and accordingly, the position of the guide portion 211 formed in the needle flow path portion 201 of the needle body 210 is also offset from the center C.

[0043] This configuration allows the cross-sectional areas (i.e., flow path areas) of the blood withdrawal section 250 and the blood return section 260 to be different when the partition plate body 301 is inserted into the needle body 210. In the illustrated example, as can be seen from Figure 11(b), the position of the partition plate body 301 is shifted towards the blood return section 260, so the cross-sectional area of ​​the blood withdrawal section 250 is larger than the cross-sectional area of ​​the blood return section 260. This offset causes the blood flow rate in the blood withdrawal side flow path (blood withdrawal section 250) to be greater than the blood flow rate in the blood return side flow path (blood return section 260) at the same flow velocity, thereby achieving the effect of physically increasing the amount of blood withdrawn.

[0044] One of the inventors of this invention, based on his many years of experience as a physician engaged in dialysis treatment, found that in order to obtain the desired blood flow rate and velocity, it is particularly desirable for blood to flow smoothly in the blood withdrawal section 250. That is, the end of the blood return section 260 is inside a blood vessel, and the inside of the blood vessel has a sufficiently larger cross-sectional area and a larger blood flow rate compared to the needle body 210. Therefore, it is thought that the blood flow resistance in the blood return section 260 is smaller compared to the blood withdrawal section 250. In addition, the blood withdrawal section 250 has a small surface area relative to the blood vessel, and it is necessary to apply negative pressure to guide the blood into the dialysis machine.

[0045] Therefore, as shown in Figure 11(b), by introducing an offset, the cross-sectional area of ​​the blood withdrawal section 250 becomes larger than the cross-sectional area of ​​the blood return section 260, and even with a needle body 210 of the same diameter, the blood flow rate can be increased at the same flow rate. As a result, the dialysis time (blood withdrawal time) can be shortened.

[0046] Furthermore, it is desirable that the cross-sectional area of ​​the blood withdrawal section 250 be approximately 10-20% larger than the cross-sectional area of ​​the blood return section 260. By setting the values ​​within this range, it is possible to increase the blood flow rate without increasing the negative pressure of the dialyzer.

[0047] <First slit, second slit> The first slit 221 is formed in the wall surface of the area that will become the blood withdrawal section 250, with communication between the inside and outside. The second slit 222 is formed in the wall surface of the area that will become the blood return section 260, with communication between the inside and outside. In the present invention, if the indwelling needle 100 is equivalent to a 16G indwelling needle, the insertion of the partition plate body 301 results in a configuration where two indwelling needles equivalent to 18G are formed on the blood withdrawal side and the blood return side. It is difficult to obtain the desired blood flow rate with these 18G equivalent indwelling needles. Therefore, the first slit 221 is installed so that the desired blood flow rate can be obtained by adjusting the pressure, flow velocity, and turbulence of the blood flow rate on the blood withdrawal side. In addition, there is a risk of reperfusion when blood is withdrawn from the needle body 210 and the purified blood is returned. Therefore, the second slit 222, which allows adjustment of pressure, flow velocity, and turbulence, is installed to prevent the occurrence of reperfusion.

[0048] In conventional technology, a through-hole (opening) was provided near the needle tip, corresponding to the first slit 221 and the second slit 222, so as to face each other on the circumferential surface at the same position from the tip. This through-hole was also intended to prevent adhesion (tight contact) with the inner wall of the blood vessel. The first slit 221 and the second slit 222 of this embodiment differ from conventional technology in that they have blood withdrawal and blood return as their primary functions. Furthermore, in conventional technology, since separate needles are generally used for blood withdrawal and blood return, the idea of ​​having one slit function as a blood return slit and the other as a blood withdrawal slit was not conceived, and because thinner needles than those of this embodiment are used, it was not practical to realize the functions of blood withdrawal and blood return with such a through-hole (making the hole larger would significantly reduce its strength).

[0049] The shapes of the first slit 221 and the second slit 222 can be, for example, a perfect circle, an ellipse, an oblong, a rounded rectangle, or an oval (egg-shaped or teardrop-shaped). An ellipse can be formed with the major axis being the extension direction of the needle body 210. In the case of a perfect circle, the diameter can be, for example, 0.5 mm. In the case of an ellipse, the extension direction can be the major axis, with the major axis being 1.0 mm and the minor axis being 0.5 mm. Furthermore, the sizes of the first slit 221 and the second slit 222 are appropriately set according to the thickness of the needle body 210. That is, the sizes of the first slit 221 and the second slit 222 can be made larger when the needle body 210 is thick, and smaller when the needle body 210 is thin.

[0050] The first slit 221 and the second slit 222 are formed with an offset in the front-to-back direction. In this embodiment, the first slit 221 is located further forward than the second slit 222. This offset effectively prevents reperfusion, where blood released into the blood vessel from the purified return channel is drawn back in from the tip of the blood withdrawal side.

[0051] As shown in Figure 2(b), when the difference between the leading edge position P1 of the first slit 221 and the leading edge position P2 of the second slit 222 is defined as offset P0, the offset P0 can be set to, for example, 1 mm to 10 mm, preferably 1.5 mm to 7.5 mm, and more preferably 2 mm to 5 mm, depending on the effective length L. The lower limit is set to prevent recirculation, which would cause the returned blood to be withdrawn. This prevents recirculation, which would cause the returned blood to be withdrawn. The inventors of this application have found, through simulations, that by setting the lower limit of the offset (P0) to the above value, the returned blood can be prevented from being immediately taken into the needle body 210. The upper limit of the offset is set considering the insertion length into the blood vessel. Furthermore, as mentioned above, by making the length of the needle body 210 40 mm or more, the first slit 221 and the second slit 222 can be made longer, thereby increasing the area for taking in blood. In addition, the restriction on offset P0 can be greatly relaxed. That is, the offset P0 can be made larger.

[0052] Here, blood is drawn in (towards the dialysis machine) from the blood withdrawal side blood flow channel (i.e., the blood withdrawal section 250) by negative pressure, and blood is also drawn in by negative pressure from the slit (first slit 221) located towards the needle tip of the blood withdrawal side blood flow channel (i.e., the blood withdrawal section 250) and sent to the dialysis machine. The blood is purified by the dialysis machine and returned to the blood vessel through the blood return side blood flow channel (blood return section 260) and the second slit 222. To explain in more detail, if the indwelling needle 100 of the present invention is placed in a shunt vein connected to the brachial artery of the human body, and assuming that the venous blood pressure in the shunt is 10-60 mmHg and the pressure (positive pressure) in the blood return flow channel is 80 mmHg, then blood will flow from the high pressure (80 mmHg) near the second slit 222 toward the blood vessel with lower blood pressure (60 mmHg).

[0053] Thus, the presence of the first slit 221 and the second slit 222 increases the flow rate of blood withdrawal and blood return. Furthermore, the offset of the first slit 221 and the second slit 222 in the anterior-posterior direction prevents the returned blood from being immediately drawn into the needle body 210. In other words, the positions of the two slits (first slit 221 and second slit 222) are offset in the anterior-posterior direction to prevent the purified blood from being drawn again by negative pressure from the blood withdrawal side blood flow path (blood withdrawal section 250).

[0054] <Another example of an indwelling needle> Next, we will describe another example (modified version) of the indwelling needle with reference to Figures 13 to 21. (Variation 1 of the needle part) Figures 13-18 show a modified example of the indwelling needle 1100. Figure 13 shows the indwelling needle 1100. Figure 13(a) is a side view of the needle portion 1200 with the puncture needle 1900 inserted. Figure 13(b) is a side view of the needle portion 1200 (sheath introducer (hereinafter also simply referred to as "sheath")) with the partition plate body 1301 (blood withdrawal function portion 1300) inserted. Figure 13(c) is a front view of the needle portion 1200 with the blood withdrawal function portion 1300 (partition plate body 1301) inserted. Figure 14 shows an example of the use of the indwelling needle 1100 (the procedure for inserting the puncture needle body 1901 and the partition plate body 1301 (blood drainage function part 1300)). Figure 15 shows three views of the puncture needle 1900, with Figure 15(a) being a side view, Figure 15(b) being a front view, and Figure 15(c) being a rear view. Figure 16 is a three-view drawing of the needle portion 1200, with Figure 16(a) being a side view, Figure 16(b) being a front view, Figure 16(c) being a rear view, Figure 16(d) being a cross-sectional view of Figure 16(a) from X8 to X8, and Figure 16(e) being a cross-sectional view of Figure 16(a) from X9 to X9. Figure 17 is a three-view drawing of the blood drainage unit 1300, with Figure 17(a) being a side view, Figure 17(b) being a front view, and Figure 17(c) being a rear view. Figure 18 is a cross-sectional view showing the connection between the needle portion 1200 and the blood-withdrawing function portion 1300. Figure 18(a) is a cross-sectional view along the extension direction, Figure 18(b) is a cross-sectional view perpendicular to the extension direction (X10-X10 cross-sectional view), and Figure 18(c) is an X11-X11 cross-sectional view.

[0055] The blood withdrawal function unit 1300 has a plate-shaped partition plate body 1301, a tip cylindrical member with a semicircular cross-section, which is a tip cylindrical portion 1350, provided at its tip, and a distribution unit (distribution unit blood withdrawal portion 1370, blood withdrawal unit connecting portion 1380) provided on the rear side of the partition plate body 1301. The distribution unit blood withdrawal portion 1370 constitutes a part of the flow path of the blood withdrawal unit and is fitted into a hose 1401 that extends to the dialysis machine via the flow path 1281. The blood withdrawal unit connecting portion 1380 is fitted into a hose 1402 that extends to the dialysis machine via the flow path 1381.

[0056] The partition plate body 1301 is inserted into the needle body 1210 and divides the flow path into a blood withdrawal section 1251 (blood withdrawal side flow path) and a blood return section 1261 (blood return side flow path). The tip tube portion 1350 protrudes from the tip of the needle body 210, and at this time, the tip tube portion 1350 is connected to the blood withdrawal section 1251. As a result, the opening of the blood withdrawal section 1251 is located towards the tip, and the opening of the blood return section 1261 is located towards the front. In other words, this configuration realizes the functions of the first slit 221 and the second slit 222 described above. The shape is intended to prevent reperfusion.

[0057] <Slit> The tip cylindrical portion 1350 of the partition plate body 1301 is provided with a first slit 1371 (blood withdrawal side slit) and a second slit 1272 (blood return side slit), which have the same function and structure as the first slit 221 and second slit 222 described above. Specifically, the first slit 1371, with a similar function to the first slit 221 described above, can reduce the pressure in the blood withdrawal side flow path (blood withdrawal section 1250) and increase the amount of blood flowing in from within the blood vessel. In addition, the second slit 1356 of the needle body 1210, with a similar function to the second slit 222 described above, can reduce the pressure of blood outflow (discharge) in the blood return side flow path (blood return section 260) and increase the blood flow rate discharged into the blood vessel.

[0058] Figures 19-21 show a modified example 2 of the indwelling needle 3100. The characteristic of the indwelling needle 3100 is that, as shown in Figures 13-18, it is a configuration in which the tip tube portion 1350 has been omitted from the configuration of the indwelling needle 1100 described above. The following will explain the differences. Figure 19 shows the indwelling needle 3100. Figure 19(a) is a side view of the needle portion 3200 with the partition plate body 3301 (blood withdrawal function portion 3300) inserted. Figure 19(b) is a front view of the needle portion 3200 with the partition plate body 3301 (blood withdrawal function portion 3300) inserted. Figure 20 is a two-view drawing of the needle section 3200, with Figure 20(a) being a side view and Figure 20(b) being a front view. Figure 21 is a two-view drawing of the blood drainage unit 1300, with Figure 21(a) being a side view and Figure 21(b) being a front view.

[0059] In the indwelling needle 3100, the needle body 3210 (sheath body) is divided into a blood withdrawal channel 3251 and a blood return channel 3261 by a partition plate body 3301, and has a blood withdrawal side slit 3271 that connects the blood withdrawal section 1251 to the outside, and a blood return side slit 3272 that connects the blood return channel 3261 to the outside. When the partition plate body 3301 is inserted into the needle body 3210 (sheath body), the tip of the partition plate body 3301 protrudes slightly. The needle body 3210 may have a tapered tip.

[0060] By inserting the needle body 3201 (sheath body) into the shunt, the direction of blood flow is from the tip of the indwelling needle 3100 toward the rear of the needle. The blood returned to the blood vessel from the tip of the blood return channel 3261 is slowly released from the tip of the blood return channel 3261 due to the difference between the blood pressure in the shunt and the pressure in the blood return channel 3261. When blood is released from the tip of the blood return channel 3261, the returned blood, which was released in the direction of blood flow in the shunt, changes direction and begins to flow toward the direction of blood flow in the shunt. If the tip of the blood withdrawal channel 3251 and the tip of the blood return channel 3261 are at the same location (same length from the rear), there is a risk that some of the purified blood released from the blood return channel 3261 may flow in from the tip of the blood withdrawal channel 3251. By having the tip 3301a of the partition plate body 3301 protrude from the tip of the needle body 3201 (sheath body), it functions as a "barrier wall" to prevent blood returned from the blood return channel 3261 from flowing into the blood withdrawal channel 3251 from the tip of the blood withdrawal channel. Furthermore, the tip 3301a of the partition plate body 3301 has a rounded shape to prevent laceration of the shunt, and the effective protruding length (protrusion size) is in the range of 3 mm to 30 mm.

[0061] The blood withdrawal slit 3271 is positioned forward of the blood return slit 3272, relative to the extension direction of the needle body 1210. This prevents reperfusion, increases the amount of blood flowing in from the blood vessel, and increases the blood flow rate discharged into the blood vessel.

[0062] The blood withdrawal channel 3251 (blood withdrawal section) of the needle body 3210 is connected to the blood withdrawal section 3370 of the distribution section of the partition plate body 3301 (blood withdrawal function section 3300) and engages with the hose 1401. On the other hand, the blood return channel 3261 (blood return section) of the needle body 3210 is connected to the blood return section 3280 of the distribution section and engages with the hose 1402 extending from the dialysis machine.

[0063] <Structure that suppresses pressure loss> Referring to Figures 22 to 26, a technique for suppressing pressure loss in the flow path of the needle body 210 and facilitating blood flow will be explained.

[0064] Figures 22 and 23 show the cross-sectional structure (Figures 22(a) and 23(a)) and the progression of the inner diameter (radius) (Figures 22(b) and 23(b)) of a commonly used indwelling needle (a needle with separate functions for blood withdrawal and blood return), respectively. In this configuration, parts 1 through 7 are assembled coaxially.

[0065] Irregularities in the flow path can obstruct blood flow. If the irregularities are large, blood will not flow smoothly, making it difficult to increase the blood flow rate during dialysis.

[0066] Figures 25 and 26 illustrate the causes of significant resistance within a flow path. When the inner diameter of a flow path narrows abruptly (especially in shapes that create steps), the fluid (i.e., blood) collides with the stepped portion. At this time, the kinetic energy of the fluid flow has nowhere to go and is thought to be converted into pressure energy. Also, when the inner diameter increases abruptly, a pressure drop occurs. Pressure fluctuations are transmitted instantaneously upstream and downstream of the fluid in the flow path. This speed is called the "pressure propagation velocity," and it is known that pressure fluctuations propagate at an extremely high speed of 1425 m / s for water at 10°C. When the fluid is water, such pressure fluctuations are called "water hammer." In this embodiment, the fluid is blood, and it is called "blood hammer." When blood hammer occurs, the turbulence of the blood intensifies, making it difficult for the blood to flow.

[0067] Therefore, as shown in Figure 24, the flow path (blood withdrawal section 250, blood return section 260) of the needle body 210 is designed so that there are no irregularities in the cross-sectional area from the tip side to the rear side. In particular, parts that expand or contract significantly are avoided. To achieve this, the flow path (inner diameter) of the needle body 210 is tapered, which suppresses the generation of turbulence and blood hammer, prevents blood flow loss, and realizes smooth blood flow, making it possible to achieve a sufficiently satisfactory blood flow rate (flow velocity) even with a single-needle type indwelling needle 100.

[0068] As described above, in the case of the 16G size, the indwelling needle 100 of the present invention has a form in which two indwelling needles equivalent to 18G are formed on the blood withdrawal side and the blood return side by inserting the partition plate body 301. The size and shape of the opening (slit) of currently used off-the-shelf indwelling needles is a perfect circle with a diameter of 0.5 mm. This is equivalent to about 1 / 3 of the outer diameter of 1.6 mm. Since the opening (slit) is horizontal to the flow of blood, it is thought that the blood flowing into the indwelling needle from the opening (slit) generates blood turbulence and blood collision, making it impossible to ensure a sufficient blood flow rate. By adopting a slit shape that suppresses the generation of blood turbulence and blood collision from the opening (slit), it is expected that a sufficient blood flow rate will be ensured.

[0069] The first slit 221 formed on the wall is horizontal to the blood flow, and the flow rate of blood flowing in through the first slit 221 differs depending on its shape and size. The blood flowing in through the first slit 221 is in a turbulent state. Collisions occur between the blood flowing in from the opening at the tip of the needle and the blood flowing in from the first slit 221. Also, as blood in the blood vessel passes through the first slit 221, the blood collides with the needle barrel surface around the outer diameter of the slit, and the magnitude of these collisions differs depending on the shape of the first slit 221. As a result, the amount of blood flowing into the first slit 221 differs depending on the shape. For example, between a perfectly round circle and a rounded rectangle with the same width and height, the rounded rectangle will allow more blood to flow into the needle.

[0070] Therefore, it is important to adjust the overall performance of the needle by balancing the shape and size of the first slit 221 with the blood flow rate flowing in from the first slit 221, blood collision, and blood turbulence from the first slit 221.

[0071] <Variations of the slit> Figure 27 shows variations in the shapes of the first slit 221 and the second slit 222. Figure 28 shows the first slit 221 and the second slit 222 of Modification 1. Figure 29 shows the first slit 221 and the second slit 222 of Modification 2.

[0072] In Figure 27(a), the shape of the first slit 221 is approximately rectangular (rounded quadrilateral), and the line segments corresponding to the shorter sides (front and rear of the opening) are curved (circular arcs) that are slightly convex outwards. This shape allows for a simple and wide opening area, and because the front and rear of the opening are curved, smooth blood withdrawal is possible. For example, in the case of a 16G with an effective length of 50 mm, the opening sizes when the slit shape is approximately rectangular (rounded quadrilateral) are, for example, 0.5 mm × 0.5 mm, 0.5 mm × 0.7 mm, 0.5 mm × 1 mm, 0.7 mm × 0.7 mm, and 0.7 mm × 1 mm.

[0073] In Figures 27(b) and 27(c), the shape of the first slit 221 is oval (teardrop-shaped) and oval (egg-shaped). The front side is roughly triangular (tapering shape), and the rear side is roughly semicircular (circular arc or elliptical arc). By using such a shape, the opening area can be reduced and the strength increased compared to a rectangle (including a square), and a balance can be struck between the flow rate and strength of blood withdrawal (or blood return in the case of the second slit 222) and blood turbulence. In Figure 27(d), the shape of the first slit 221 is circular. In this example, the strength can be increased.

[0074] <Installation locations of the first and second slits (slit installation area)> The first slit 221 and the second slit 222 are positioned offset anteriorly and posteriorly relative to the extending direction of the needle body 210. This is to prevent (or minimize) the inflow of purified blood flowing out from the second slit 222 through the first slit 221. For example, in the case of a 16G indwelling needle with an effective length of 50mm, the upper limit for the placement of the first slit 221 and the second slit 222 within the blood vessel is approximately 10mm from the needle tip (1 / 5 of the effective length). The placement range for the first slit 221 and the second slit 222 should be within 5mm.

[0075] <Slit dimensions (vertical and horizontal)> The slit sizes for each shape in Figures 27, 28, and 29 will be explained using the inner diameter size of a 16G needle as an example. The lateral width of the slit is capped at 1 mm, which is 2 / 3 of the needle's outer diameter of 1.6 mm. The vertical width of the slit varies depending on the effective length of the needle and the length it is inserted into the blood vessel and left in place. However, when the effective length of the needle is 50 mm due to the placement of the first slit 221 and the second slit 222, the two slits are placed within a 5 mm range, so the vertical width of the slit is capped at 2.5 mm.

[0076] <Method for preventing recirculation using slits> Let's explain the second slit 222 in the blood return channel. If the second slit 222 is not present in the blood return channel, the purified blood is released into the blood vessel from the tip of the blood return channel due to the pressure (positive pressure) in the blood return channel. The amount of blood released depends on the value of the pressure (positive pressure) in the blood return channel and the blood pressure of the human veins. If the difference between the blood pressure in the blood vessel and the pressure (positive pressure) in the blood return channel is large, the pressure of the purified blood released into the blood vessel from the tip of the blood return channel is high, so it is released forcefully and the blood flow rate is also high. If the pressure (positive pressure) at the tip of the blood return channel is high, the blood flow velocity is high, and purified blood is forcefully discharged from the tip, while purified blood flows in from the tip of the blood withdrawal channel. This is called reperfusion. In other words, the amount of purified blood that flows back in on the withdrawal side increases, which is a problem in dialysis procedures that perform blood purification. Therefore, it is necessary to discharge the purified blood discharged from the tip of the blood return channel by suppressing the discharge pressure, discharge blood flow velocity, and discharge blood flow rate. To this end, a second slit 222 is installed behind the tip, and the purified blood discharged from the second slit 222 is discharged into the blood vessel at a low blood flow velocity due to the high discharge pressure. The purified blood that does not discharge from the second slit 222 and flows toward the tip of the blood return channel has a low pressure at the tip of the blood return channel, and the discharge pressure of the purified blood discharged from the tip is also reduced, thus reducing the blood flow rate. Thus, reperfusion can be suppressed.

[0077] <Effect of the second slit 222> In the second slit 222, purified blood flowing through the blood return channel is released from the second slit 222 at a discharge pressure higher than the positive pressure and a low blood flow velocity, causing the blood to move into and be released into blood vessels with a blood pressure lower than the positive pressure. The blood flow rate released from the second slit 222 depends on the shape and area of ​​the second slit 222.

[0078] <Method for preventing recirculation using slits / Area × Pressure> Furthermore, another method to prevent the purified blood discharged from the tip of the blood return channel from being reperfused will be described. By increasing the shape and area of ​​the second slit 222, the discharge pressure of the discharged blood can be reduced, thereby increasing or decreasing the blood flow rate of the purified blood discharged from the tip.

[0079] In the case of the 16G indwelling needle mentioned above, the concept is that two indwelling needles with a cross-sectional area equivalent to 18G are formed. The cross-sectional area (tip) of this 18G is 0.52 mm². 2Therefore, by making the area of ​​the second slit 222 an opening of the same size, the pressure (positive pressure) is divided in two.

[0080] For example, if the blood pressure in the shunt vein is 10-60 mmHg and the positive pressure (pressure for blood return) is 100 mmHg, the pressure is divided in half by the second slit 222, resulting in 50 mmHg. At the tip of the blood return side, there is a blood pressure of 10-60 mmHg, and with the divided pressure of 50 mmHg, the discharge pressure and discharge blood flow velocity will be low as the blood is released from the tip.

[0081] Furthermore, by making the area of ​​the second slit 222 larger than the cross-sectional area of ​​the tip, the pressure (positive pressure) is further divided. Therefore, the tip cross-sectional area equivalent to 18G is 0.52 mm². 2 Therefore, if the area of ​​the second slit 222 used on the blood return side is greater than or equal to the cross-sectional area of ​​18G, the flow velocity and flow rate of blood discharged from the second slit 222 will be greater than the blood discharged from the tip, thus preventing re-perfusion.

[0082] The area of ​​the first and second slits is 0.2 mm². 2 ~1.5mm 2 This is the range within which the strength is effective. The area corresponds to the size of a 0.5 mm perfect circle to the size of a 1 x 1.5 mm rounded rectangle.

[0083] <Method 2 for preventing reperfusion using a slit / Slit on the blood withdrawal side> This section describes the first slit 221 in the blood withdrawal channel. By creating two channels with a partition plate, a 16G equivalent indwelling needle becomes thinner, equivalent to an 18G needle. This leads to a problem where the blood flow rate drawn from the blood vessel decreases. To draw in more blood from the blood vessel (blood withdrawal), it is necessary to lower the pressure in the blood withdrawal channel and increase the flow velocity. This can be achieved by installing the first slit 221 in the blood withdrawal channel. The pressure (negative pressure) required to draw blood from the blood vessel into the dialysis machine can be lowered by opening the first slit 221, thereby increasing the flow velocity of the blood flowing in from the blood vessel. As a result, the pressure can be lowered due to the pressure difference between the blood pressure and the negative pressure in the blood vessel, thus increasing the blood flow rate of the incoming blood. By using a first slit 221 with a larger cross-sectional area than that of an 18G equivalent needle and increasing the blood flow velocity, it is expected that the blood flow rate can be increased to that of a 17G or 16G equivalent needle.

[0084] <Slit area range> The opening area in conventional off-the-shelf products is, for example, 0.19 mm². 2 Two perfect circles (with an outer diameter of 0.5 mm) are provided, and the total area is 0.38 mm². 2 This is the result. In conventional off-the-shelf products, the focus is not on controlling pressure, flow velocity, and collisions, but rather on avoiding contact between the needle and the blood vessel wall. In this invention, the slit for increasing blood flow velocity and blood flow rate is 0.52 mm. 2 The above slit area shape is the lower limit, and the upper limit varies depending on the needle size, but using a 16G needle as an example, the slit area is 1.4 mm². 2 (0.7mm x 2mm) is the upper limit due to the needle's strength.

[0085] <Expected flow rate through the slit on the blood withdrawal side> For example, assuming that the blood pressure of the shunt vein when the indwelling needle 100 of the present invention is indwelling in a vein is 20 to 100 mmHg and the negative pressure is 200 mmHg, the pressure is halved by the first slit 221 to a negative pressure of 100 mmHg, and the flow rate is estimated to increase due to the lower pressure. Blood moves (flows in) from the blood vessel with high pressure to the blood extraction side flow path (blood extraction part 250) with low pressure via the first slit 221. At the opening at the tip on the blood extraction side smaller than the opening area of the first slit 221, the pressure divided by the negative pressure of 80 mmHg or more and the blood pressure of 100 mmHg in the shunt blood vessel results in an inflow pressure of 20 mmHg, so the blood flow rate increases at the tip and blood flows in. Therefore, the tip cross-sectional area of an 18G needle is 0.52 mm 2 From this, if the area of the first slit 221 used on the blood return side is greater than or equal to the cross-sectional area of an 18G size needle, the flow rate of the blood flowing in from the first slit 221 is increased compared to the blood flowing in from the tip, and the flow rate can be increased, approaching the blood extraction blood flow rate of 17G size or 16G size.

[0086] <Number of slits installed> Figures 28 and 29 show examples in which a plurality (here, two) of the first slit 221 and the second slit 222 are provided respectively. Figures 28(a) and 29(a) show the first slit 221 (the slit on the blood extraction side), and Figures 28(b) and 29(b) show the second slit 222 (the slit on the blood return side).

[0087] The difference between Figures 28 and 29 lies in the slit shape, and the shape of Figure 29 is longer in the front-back direction. This shape is generally called an oval shape, similar to the shape of an egg or a drop, and the inflow efficiency due to liquid collision and turbulence when blood flowing parallel to the slit surface flows in is higher than that of a perfectly circular slit.

[0088] The first slit 221 has a first slit (A) 221a and a first slit (B) 221b. The first slit (A) 221a and the first slit (B) 221b are symmetrical in the front-to-back direction, and the first slit (A) 221a is positioned slightly towards the front (towards the tip).

[0089] The second slit 222 has a second slit (A) 222a and a second slit (B) 222b. The second slit (A) 222a and the second slit (B) 222b are symmetrical in the front-to-back direction, and the second slit (A) 222a is positioned slightly towards the front.

[0090] By configuring the first slit 221 and the second slit 222 in this way, it is possible to increase the blood flow rate during blood withdrawal and return while maintaining the strength of the needle portion 200 (needle body 210).

[0091] <Thickness of the needle body (body-side flow path)> The diameter of the needle body 210 can be, for example, 14G (outer diameter 2.1 mm) to 16G (outer diameter 1.6 mm). A thinner needle is preferable from the viewpoint of reducing pain during puncture, while a thicker needle is preferable from the viewpoint of increasing the flow rate. In this embodiment, the indwelling needle 100 is a single-needle type, and since blood withdrawal and return are performed with a single needle portion 200 (needle body 210), it tends to be thicker. However, by applying new technologies to the slit and internal flow path, the increase in the diameter of the needle body 210 can be suppressed.

[0092] The inner diameter of the body-side flow path 219 (the portion with an effective length L) exhibited by the needle body 210 of the needle portion 200 may, for example, be a straight, constant diameter, or it may gradually widen in a tapered manner from the tip side (left side in the figure) to the base side (needle bottom 220 side, right side in the figure). When the inner diameter is gradually widened, the flow rate of the needle portion 200 can be increased compared to a configuration in which the inner diameter of the flow path extends in a straight line.

[0093] <Tapered shape of the needle channel section (needle body)> The tapered shape of the needle body 210 will be described with reference to Figures 30 and 31. The inner diameter of the flow path exhibited by the needle body 210 of the needle portion 200 is such that the size of the inner diameter at a certain position in the extension direction of the needle body 210 is greater than or equal to the size of the inner diameter further towards the tip, and at least a portion of it gradually widens from the tip side (front side) to the base side (rear side). Because it widens gradually, sudden pressure fluctuations do not occur.

[0094] In such a structure, the cross-sectional shape (i.e., inner diameter) of the flow path is tapered. The entire structure may be tapered, or a straight shape may be provided in part. The tapered shape is provided in a region of 80% or more of the length of the needle body 210 (more specifically, the effective length of the subcutaneous insertion range).

[0095] Furthermore, the taper ratio of the tapered shape is 1% to 3%, preferably 1.2% to 2.8%, and more preferably 1.5% to 2.5%. The taper ratio is calculated using the following formula (1), as shown in Figure 30, where d is the diameter of the smaller side, D is the diameter of the larger side, and L is the distance between them. Taper ratio (%) = (Dd) × 100 / L ... (1)

[0096] Here, a taper ratio of 1% means that when the needle is inserted 5mm into the skin, its diameter increases by 0.05mm. This is a needle with a taper ratio of 1% (indwelling needle 100). A larger taper ratio increases the flow rate, but conversely, it increases the burden on the skin (wound, pain) and makes hemostasis after needle removal more difficult. Therefore, it is desirable to adopt a taper ratio within the above range to balance the burden on the skin with the increase in flow rate. Accordingly, as shown in Figure 31, the above taper ratio can be used in the area of ​​the effective subcutaneous insertion length L, and a larger taper ratio (for example, 5% or more) can be used above the subcutaneous area (the area that does not penetrate the skin).

[0097] Regarding the tapering shape of the flow path, the above description assumes a structure in which the entire flow path is tapered. However, this is not limited to this; the cross-sectional area at a certain point in the flow direction of the blood withdrawal flow path may be greater than or equal to the cross-sectional area further towards the tip. Similarly, the cross-sectional area at a certain point in the flow direction of the blood return flow path may be greater than or equal to the cross-sectional area further towards the tip. In this case, the cross-sectional area of ​​one of the flow paths may be kept constant.

[0098] <Needle bottom> The needle base portion 220 is the part located on the rear side (right side in the illustration) of the needle body 210 and is connected to the main body portion 400. Here, it is fitted through the mounting opening 405 provided in the main body portion 400 and housed in the housing portion 401.

[0099] The needle base portion 220 is integrally constructed from a rear cylindrical portion 220a and a front reduced-diameter portion 220b. The needle base side channel 229 formed inside the needle base portion 220 has a first needle base side channel 229a, a second needle base side channel 229b, and a third needle base side channel 229c. The third needle base side channel 229c is the portion where the first needle base side channel 229a and the second needle base side channel 229b merge in the reduced-diameter portion 220b. In other words, the third needle base side channel 229c branches into the first needle base side channel 229a and the second needle base side channel 229b.

[0100] The cylindrical portion 220a has a circular outer shape. The cylindrical portion 220a is provided with a first needle bottom side channel 229a and a second needle bottom side channel 229b.

[0101] <In-flow channel housing section 270> As shown in Figures 5 and 6(a), a flow channel housing section 270 is provided inside the cylindrical section 220a. The flow channel housing section 270 holds the puncture needle 900 and partition plate 300 in the state of use when they are inserted.

[0102] The internal channel housing section 270 is a wall surface that divides the internal channel of the cylindrical section 220a (needle-bottom side channel 229) into left and right regions (first opening 231 side and second opening 232 side). In other words, the internal channel housing section 270 divides the internal channel of the cylindrical section 220a into a first needle-bottom side channel 229a and a second needle-bottom side channel 229b. To put it another way, the side surface of the internal channel housing section 270 is configured as part of the channel wall surface of the first needle-bottom side channel 229a and the second needle-bottom side channel 229b.

[0103] For example, the first needle bottom side channel 229a is connected to the first connecting portion 410 of the main body 400 via the first opening 231. The second needle bottom side channel 229b is connected to the second connecting portion 420 of the main body 400 via the second opening 232. Furthermore, the first needle bottom side channel 229a and the second needle bottom side channel 229b merge into the third needle bottom side channel 229c on the front side, i.e., inside the reduced diameter section 220b. The third needle bottom side channel 229c further connects to the main body side channel 219 on the front side.

[0104] For example, as shown in Figure 6(e), the channel housing portion 270 has a through hole 271 that extends from the back surface 225 to the front tip portion 273 and connects to the third needle base side channel 229c. The through hole 271 is located in the center of the circular shape formed by the back surface 225 when the needle base portion 220 is viewed from the rear, as shown in Figure 5(d). The puncture needle 900 and the partition plate 300 are inserted into the through hole 271.

[0105] When the puncture needle 900 is inserted into the through hole 271 and is in use, that is, when the tip of the puncture needle body 901 protrudes from the tip of the needle body 210, the base 902 is fixed in a predetermined position in the through hole 271.

[0106] When the partition plate 300 is inserted into the through hole 271 and the device is in use, that is, when the partition plate body 301 is inserted into the needle body 210 and is in its foremost position, the base portion 302 completely fills the through hole 271, and the tip portion of the base portion 302 (the portion connecting to the partition plate body 301) protrudes from the tip portion 273.

[0107] The needle base 220 is configured to gradually widen at the boundary with the needle body 210. In other words, the internal flow path of the needle base 220 is configured to gradually widen in cross-sectional area from the needle flow path portion 201 of the needle body 210.

[0108] The needle base 220 has a first opening 231 on its side facing each other, which connects a flow path (in this case, a blood withdrawal section 250) to the first connecting section 410 of the main body 400, and a second opening 232 which connects a flow path (in this case, a blood return section 260) to the second connecting section 420.

[0109] At the center of the bottom of the needle base 220, a partition wall containing a passage 270 is provided, which extends forward. The passage accommodating section 270 is formed as a hollow tube, and the puncture needle 900 and partition plate 300 are inserted through and housed in it from the rear side, with the puncture needle 900 and the partition plate body 301 of the partition plate 300 protruding from its tip opening. The outer wall surface of the passage accommodating section 270 forms part of the passages of the blood withdrawal section 250 and the blood return section 260.

[0110] <Guide section inside the needle body> The needle body 210 of the needle section 200 has a needle flow path section 201 with a groove-shaped guide section 211 formed on its inner wall surface, extending in the direction of the flow path (left-right direction in the illustration).

[0111] The two grooves constituting the guide section 211 are arranged to face each other, and the side end faces of the partition plate body 301 of the partition plate 300 are fitted into them. When the partition plate body 301 is fitted into the guide section 211, the needle flow path section 201 is divided into the blood withdrawal section 250 and the blood return section 260, and liquid-tightness is reliably ensured without the partition plate body 301 wobbling. In this embodiment, a pair of guide sections 211 are provided, but multiple pairs may be provided to make the cross-sectional areas of the blood withdrawal section 250 and the blood return section 260 different.

[0112] <Main body> The main body 400 is connected to the needle 200. Specifically, the main body 400 has a housing space (housing section 401) that accommodates the needle base 220. The housing section 401 has an attachment opening 405 on the front side (left side in Figure 7(a)) for inserting the needle base 220 of the needle 200, and a fixing connection section 430 on the rear side (right side in Figure 7(a)) for inserting and fixing the puncture needle 900 and partition plate 300. In addition, a hemostatic valve 500 is positioned at the bottom surface of the housing section 401 where it connects to the fixing connection section 430, ensuring liquid tightness when the puncture needle 900 and partition plate 300 are inserted.

[0113] The main body 400 further includes a first connecting portion 410 and a second connecting portion 420. Specifically, the first connecting portion 410 and the second connecting portion 420 are openings provided opposite each other on the side surfaces of the main body 400, and they connect the housing portion 401 to the outside.

[0114] With the needle base 220 housed in the housing 401, the first connecting portion 410 is connected to the first opening 231 (blood withdrawal opening) of the needle base 220. Similarly, the second connecting portion 420 is the second opening 232 (return opening) of the needle base 220.

[0115] The shape of the connection portion between the first connecting portion 410 and the first opening 231 is identical, resulting in a seamless connection. Similarly, the shape of the connection portion between the second connecting portion 420 and the second opening 232 is identical, resulting in a seamless connection.

[0116] For example, the resin exemplified as the material for the needle portion 200 can be used as the material for the main body portion 400, as long as it is a material that does not cause blood clots during use.

[0117] <Hemostatic valve> The hemostatic valve 500 is formed in a cylindrical shape from an elastic material such as isoprene rubber or silicone rubber, or an elastomer. The shape of the hemostatic valve 500 is not particularly limited; for example, it may be conical. The hemostatic valve 500 has a slit that penetrates through the center in the front-to-back direction, and is opened only when the partition plate 300 or the puncture needle 900 is inserted.

[0118] <Partition plate> Figure 8 shows a four-view drawing of the partition plate 300. The partition plate 300 is inserted through the needle portion 200 and divides the needle flow path portion 201 into a blood withdrawal portion 250 and a blood return portion 260. More specifically, the partition plate 300 has a partition plate body 301 fixed to the needle body 210 and a base portion 302 that is housed and fixed inside the needle base portion 220 (more specifically, the flow path housing portion 270).

[0119] The partition plate body 301 is formed in a plate shape, and its thickness can be, for example, about 0.1 to 0.6 mm. The width of the partition plate body 301 is set appropriately depending on the cross-sectional area of ​​the needle body 210, the position when inserting the needle body 210, the presence or absence of a guide, etc. The length of the partition plate body 301 is also set appropriately considering the length of the needle body 210, etc.

[0120] The base portion 302 is approximately cylindrical in shape, with a tapered diameter at the tip, and is smoothly connected to the partition plate body 301. The diameter of the base portion 302 can be, for example, 1 to 6 mm. The shape of the base portion 302 is not limited to a cylindrical shape; it may also be a rectangular parallelepiped or a polygonal prism such as a triangular prism.

[0121] As the material for the partition plate 300, for example, the resin exemplified as the material for the needle portion 200 can be used, or metals such as stainless steel, or composite materials of resin and metal can be used. Furthermore, different parts of the partition plate 300, for example, the partition plate body 301 and the base portion 302, may be formed from different materials.

[0122] <Partition plate inserter> The device further includes a partition plate insertion device (cartridge 305) connected to the rear of the main body 400, which feeds (inserts) the partition plate 300 into the needle portion 200 of the retaining needle 100.

[0123] The partition plate inserter and the partition plate 300 are configured as a cartridge in which the partition plate is housed in the partition plate inserter. Through a predetermined operation, the partition plate 300 protrudes from an opening provided at the tip of the cartridge 305, and the partition plate 300 is inserted into the interior of the retaining needle 100.

[0124] Specifically, the cartridge 305 has an insertion portion 306 provided at the tip of the cartridge body. The tip of the insertion portion 306 is sloped (in this case, a mountain-shaped protrusion) to facilitate passage through the hemostatic valve 500. In addition, the base of the insertion portion 306 is a widened stepped portion 307, and when the partition plate 300 is inserted into the needle portion 200, the stepped portion 307 abuts against the fixed connection portion 430 to position it (i.e., position the tip side in the insertion direction). An operating opening (not shown) is formed on the side or bottom surface of the partition plate 300. The partition plate 300 is operated through the operating opening, and the partition plate body 301 is fed out from the tip.

[0125] The insertion of the partition plate 300 into the needle portion 200 will be briefly explained. This operation takes place after the needle portion 200 has been punctured into a blood vessel in the patient's arm by the puncture needle 900. Prepare the cartridge 305 so that the partition plate 300 is fully housed inside it. Next, the insertion portion 306 of the cartridge 305 is inserted into the needle portion 200 from the fixed connection portion 430. When the cartridge 305 is pushed in, the insertion portion 306 passes through the hemostatic valve 500 and enters the needle flow path portion 201. The cartridge 305 is pushed in until the stepped portion 307 contacts the fixed connection portion 430. After the stepped portion 307 contacts the fixed connection portion 430, the partition plate 300 is operated and moved forward. This causes the partition plate body 301 to fit into the guide portion 211 of the needle body 210, and the needle flow path portion 201 is divided into the blood withdrawal portion 250 and the blood return portion 260. After that, the cartridge 305 is separated from the partition plate 300. At this time, the base 302 of the partition plate 300 is held by the hemostatic valve 500 and the fixed connection part 430.

[0126] Furthermore, methods such as an electric motor type, wire type, screw gear type, ball screw type, spring type, or push-in type can be applied to insert (feed out / move) the partition plate body 301 located inside the partition plate cartridge 305 into the interior of the retaining needle 100 (needle flow path section 201).

[0127] <Arm support> It is equipped with an arm restraint that attaches to the main body and is also worn on the patient's arm. The arm fixation part includes a fixing belt and a base that maintains the indwelling needle 100 at a predetermined angle relative to the arm. The predetermined angle is the angle at which the indwelling needle 100 is inserted into the patient's blood vessel during dialysis. The predetermined angle may be configured to be adjustable. This can suppress movement of the indwelling needle 100 that occurs in the punctured arm.

[0128] In summary, the effects of the indwelling needle 100 of this embodiment are as follows: Traditionally, patients undergoing blood purification therapy used the same puncture site every week, for example. However, this embodiment allows for a change to a cycle where the same puncture site is used every two weeks. In other words, it allows for a cycle of two weeks, which is sufficient for natural recovery from skin and blood vessel lacerations. Furthermore, it becomes possible to significantly reduce the number of puncture sites from the conventional six on the arm to three.

[0129] <Medical Device Management System> <Overview of Medical Device Management Systems> Next, the management technology for the indwelling needle 100 described above will be explained with reference to Figures 32 to 39. The management of the indwelling needle 100 is carried out by the following medical device management system 1. Here, the management technology for a dialysis medical device 80 comprising a dialysis indwelling needle set 80x and a peripheral device, a dialyzer 80d, as the indwelling needle 100 will be explained. The management technology described here is an example of applying the technology of Japanese Patent No. 6709479 disclosed by the applicant of this application. The indwelling needle 100 described above will be used as an example of the dialysis indwelling needle set 80x.

[0130] Figures 32 and 33 show an overview of the delivery management of dialysis medical devices 80 to dialysis patients 99 by the medical device management system 1 according to this embodiment. The medical device management system 1 introduces the concept of IoT (Internet of Things) into the delivery management of medical devices 80 and manages medical devices 80 all over the world.

[0131] Specifically, dialysis patients 99 (including patients undergoing peritoneal dialysis at home) enter into a subscription agreement for medical devices 80. When concluding a subscription agreement, dialysis patients 99 or medical institutions access a designated website, as described later, and specify (or, with the advice of the medical institution) the desired medical device 80 (hereinafter referred to as a dialysis indwelling needle set 80x or dialyzer 80d) from the desired manufacturer. The medical devices 80 are equipped with traceable RFID 81, and by monitoring the usage status of the medical devices 80 by dialysis patients 99, the number of remaining dialysis sessions and medication administrations can be calculated. This optimizes product inventory, user inventory, and logistics for medical devices 80 and pharmaceuticals, eliminating waste and realizing a new type of subscription system that delivers only what is needed, when it is needed. Furthermore, by understanding the usage status and contract details of the medical devices 80 by dialysis patients 99, the system can systematically determine the quantity and timing of use (i.e., shipping timing, etc.) of medical devices 80 and pharmaceuticals needed for all dialysis patients 99 using the system, enabling automatic ordering to manufacturers and support for planning manufacturing and shipping schedules. This will reduce the medical expenses of dialysis patients 99, as well as the procurement costs of medical devices 80 at medical institutions and the manufacturing costs of manufacturers of medical devices 80. In this embodiment, among the medical devices used in hemodialysis, disposable medical devices will be described as "medical devices," and the medical devices of the apparatus will be described as "medical devices."

[0132] Let me briefly explain the frequency of dialysis. Overseas (outside of Japan), it is known that dialysis performed at home can be done daily at a time of the patient's choosing. In Japan, dialysis performed at a medical facility is typically done three times a week (every other day), but patients undergoing hemodialysis at home can choose to have dialysis three to seven times a week, depending on their convenience. Therefore, when patients undergoing hemodialysis at home enter into a subscription contract, they can choose how many times they will have dialysis per week, from three to seven times.

[0133] Dialysis patients 99 undergo dialysis (maintenance hemodialysis) at home or at a dialysis facility (hospital) at a rate of three times a week or daily. A dialysis machine 86a is installed at the place where dialysis is performed (i.e., home or dialysis facility) as a medical device 86 for artificial dialysis. Dialysis patients 99 have a subscription contract to purchase medical devices 80 used for dialysis, including a dialysis indwelling needle set 80x, a dialyzer 80d, dialysis water, a dialysis line, medications, tape, and protective equipment. These are delivered directly to the patient's home or medical institution from the respective manufacturers' factories 90 (or warehouses 91) on a regular basis. The dialysis indwelling needle set 80x is intended to be reused multiple times (e.g., 5 times) after cleaning. The dialyzer 80d is discarded after each use. Dialysis patients can choose the medical devices (dialysis indwelling needle set 80x and dialyzer 80d) that are best suited to them, as well as the medications used during dialysis. For example, they can customize the dialyzer 80d by specifying whether it is a natural membrane type or a synthetic membrane type (and further, whether it is made of polysulfone or polymethyl methacrylate), specifying the manufacturer, or specifying the needle gauge for the dialysis indwelling needle set 80x. Stockpiling dialysis water and storing it at home requires a room or warehouse, but regular deliveries save space. It is also possible to purchase or subscribe to a reverse osmosis water production system (reverse osmosis system) for producing dialysis water. In recent years, development of miniaturized dialysis machines 86a has progressed, and portable, compact dialysis machines have also been proposed. Such compact dialysis machines are suitable as home dialysis machines, and for dialysis patients 99 who previously found it difficult to adopt such systems due to installation space and equipment costs, it becomes more accessible to install a dialysis machine 86a at home and perform dialysis without going to a dialysis facility. The dialysis machine 86a can be purchased, but it can also be used on a subscription basis for a fixed monthly fee.And in such a situation, through a subscription contract, by regularly delivering dialysis indwelling needle sets 80x, dialyzers 80d, drugs, etc. to under dialysis patients 99 or under medical institutions and dialysis facilities, the burden on dialysis patients 99 and dialysis facilities (i.e., medical staff) to arrange them can be significantly reduced. For dialysis patients 99 and medical facilities in private practice, the burden of purchasing expensive dialysis devices 86a, reverse osmosis water purification devices (reverse osmosis devices), etc. is eliminated.

[0134] Here, regarding the subscription contract using the medical device management system 1, the cost merit of price reduction for patients who perform hemodialysis at home will be explained.

[0135] The dialysis indwelling needle set 80x can be used multiple times by cleaning it with a dedicated cleaner as described above. For example, assuming that the dialysis indwelling needle set 80x can be used up to 5 times by cleaning, in the case of conventional indwelling needles, since 2 indwelling needles are used for one dialysis, 2 × 5 = 10 indwelling needles are required, while only 1 set of the dialysis indwelling needle set 80x is sufficient, resulting in a difference in terms of cost and storage space. Also, for medicinal materials, the drugs to be used for the number of dialysis sessions during the subscription contract period will be purchased regularly in volume conversion, and there will also be a difference in terms of cost and storage space compared to purchasing drugs each time. The medical device management system 1 is a system that provides cost benefits to users.

[0136] In medical institutions and medical facilities, medical instruments such as indwelling needles are discarded after one use without being reused among patients to prevent infectious diseases in patients. This leads to high costs prioritizing infectious diseases. The medical device management system 1 is a system suitable for patients who perform dialysis at home. By monitoring and ensuring disinfection cleaning through cleaning and allowing the same patient to reuse in a state where the risk of generating infectious diseases among patients is eliminated, a medical device management system 1 that can reduce the overall cost for patients regarding the purchase of medical instruments can be realized.

[0137] <Management Using RFID> Here, the medical device management system 1 manages contracts with dialysis patients 99, manages the manufacturing and delivery of medical devices 80, and manages the use of medical devices 80 by dialysis patients 99. Specifically, RFID 81 is attached to the medical devices 80 (dialysis indwelling needle sets 80x and dialyzers 80d), and the management server 10 reads and writes the RFID 81 to manage supply (manufacturing, inventory, shipping) and use. There are various types of RFID 81, such as rewritable and read-only types, and processing is performed according to the type. For example, if the RFID 81 is rewritable, various information can be recorded on the RFID 81 not only in the distribution process after shipment and after delivery to the user, but also on the management server 10 and the user-side reader / writer 85. For example, if the RFID 81 is read-only, information is not updated on the RFID 81 itself after shipment, but the information is added and updated on the management server 10 and the user-side reader / writer 85.

[0138] At the manufacturing plant for dialysis indwelling needle sets 80x and dialyzers 80d, the medical device management system 1 links the ID information of each RFID 81 attached to the dialysis indwelling needle set 80x and dialyzer 80d during manufacturing with the ID information (contract information) of dialysis patients 99. This allows, for example, the owner to be identified simply by reading the ID on the needle part of the dialysis indwelling needle set 80x.

[0139] More specifically, the dialysis indwelling needle set 80x shows an example using the indwelling needle 100 as described above. The indwelling needle 100 has a needle portion 200, a main body portion 400, a partition plate 300, and a puncture needle 900. RFIDs 82, 84, 83, and 89 are attached to the needle portion 200, the main body portion 400, the partition plate 300, and the puncture needle 900, respectively. RFID 81d is attached to the dialyzer 80d. Note that if RFIDs 82, 84, 83, 89, and 81d are not distinguished, they will simply be described as RFID 81.

[0140] The management server 10 calculates a delivery schedule based on the contract details (orders) with dialysis patients 99, the progress of use by dialysis patients 99 and medical facilities, the number of new contracts, and the number of days for delivery to patients' homes and medical facilities, and instructs the factory 90 to manufacture and ship the medical devices 80. When the factory 90 manufactures and ships the medical devices 80 with RFID 81 attached, it reports this to the management server 10. During manufacturing and shipping, product information, manufacturing information, and the intended user (dialysis patient 99) are written to the RFID 81. Once delivery to dialysis patients 99 is complete, the information is reflected in the management server 10 based on notifications from the delivery company and the receiving dialysis patients 99.

[0141] When a dialysis patient 99 undergoes dialysis, a user-side reader / writer 85 connected to the medical device 86 reads the information written on the RFID tags 81 (82, 84, 83, 89, 81d) of the medical device 80 (in this case, the dialysis indwelling needle set 80x and the dialyzer 80d). The system checks whether the dialysis patient 99 has a contract for these devices and whether they are in a usable condition (within the reuse limit for the dialysis indwelling needle set 80x, or new for the dialyzer 80d). The dialysis indwelling needle set 80x (needle unit 200, main unit 400, partition plate 300, and puncture needle 900) may be managed as a whole under a single expiration date, or the needle unit 200, main unit 400, partition plate 300, and puncture needle 900 may each be managed separately under different expiration dates. In this case, certain components, such as the puncture needle 900, may be discarded after each use, similar to the dialyzer 80d.

[0142] The check results (i.e., usage data) are notified to the management server 10 from the user terminal 70 to which the medical device 86 (user-side reader / writer 85) is connected. If available, artificial dialysis is performed by the dialysis machine 86a. At this time, the usage history is written to the management server 10 via the RFID 81 (if it is a rewritable type) and the user-side reader / writer 85. The read / write control function using the RFID 81 may be installed in the medical device 80 (dialysis machine 86a or cleaning device 86b) or in the user terminal 70.

[0143] Furthermore, the medical device 86 and user terminal 70 display the check results and notify the dialysis patient 99 whether the use is appropriate or not. If the use is inappropriate, a warning is issued, the patient is instructed to stop using the appropriate medical device 80, and is encouraged to use the appropriate medical device 80. If the user terminal 70 is a smartphone or tablet, an application to manage the operation, usage history, and cleaning history of the medical device 86 may be installed, and a user-side reader / writer 85 may be connected to read and write RFID 81. In this case, location information obtained using the GPS function, IP address (network address), MAC address, etc. attached to the personal terminal such as a smartphone or tablet is associated with the usage history, etc., and notified to the management server 10. If the use is outside of the registered location (location information), the management server 10 can determine that there is a possibility of misuse and can process a request for confirmation from the dialysis patient 99, etc. Furthermore, the GPS function, IP address (network address), and MAC address can be used to aggregate usage and consumption figures for all users in each area, such as by city, prefecture, region, country, or continent, i.e., the minimum daily production quantity, as well as monthly required quantity aggregations, i.e., production quantity, shipment quantity, number of packaging units, package weight, shipping fee aggregation, and arrangement of shipping procedures.

[0144] After hemodialysis is completed, the reusable dialysis indwelling needle set 80x is cleaned by the cleaning device 86b. The cleaning device 86b is also equipped with a user-side reader / writer 85, and the cleaning history is written to the RFID 81 (RFID 82, 84, 83, 89) of the dialysis indwelling needle set 80x, and this information is notified to the management server 10 from the user terminal 70.

[0145] The management server 10 tracks the user inventory of dialysis patients 99 based on the usage and cleaning history of the medical devices 80 remaining at the patients' homes (or dialysis facilities). When the user inventory falls to a predetermined level, the server issues a manufacturing and shipping instruction to the factory 90.

[0146] <Configuration of Medical Device Management System> Figure 34 is a block diagram showing the schematic configuration of the medical device management system 1. The medical device management system 1 comprises a management server 10, user terminals 70, and medical devices 86, all connected on a network 2.

[0147] <Medical device 86> As described above, the medical device 86 includes a dialysis machine 86a and a cleaning machine 86b used for hemodialysis of dialysis patients 99. The medical device 86 is connected to a user-side reader / writer 85 for reading / writing RFID 81 attached to medical instruments 80. The medical device 86 is connected to the management server 10 via the network 2, either directly or via a user terminal 70.

[0148] The cleaning device 86b, for example, cleans the indwelling needle by setting a solution cartridge. Specifically, the cleaning device 86b has a cleaning chamber and a solution supply unit. The cleaning chamber houses and cleans the indwelling needle in its disassembled components. The solution cartridge contains solutions of different types to be used for cleaning. The solution supply unit supplies the solution from the solution cartridge to the cleaning chamber.

[0149] As for cleaning methods, for example, cleaning methods using running water and ultrasonic waves can be used. The solution cartridge contains a cleaning solution (type, concentration, volume) suitable for the cleaning method, and the solution cartridge to be used is selected depending on how many times the indwelling needle to be cleaned has been cleaned. The type of cleaning solution contained in the solution cartridge may be recorded on the RFID tag 81, and the cleaning device 86b reads the RFID tag 81 to determine if the appropriate solution cartridge has been set, and the history of the solution cartridges used may also be managed.

[0150] <User terminal> User terminals 70 include, for example, the personal terminal 71 of a dialysis patient 99 or the medical institution terminal 72 of a dialysis facility. If the dialysis patient 99 lives overseas and the medical device 86 is exported from Japan, a designated agent (representative) may be involved, in which case the user terminal 70 includes the agent terminal 75 used by the agent. The dialysis patient 99 and the medical institution can use their respective user terminals 70 to enter into contracts online and to check and change the contract details. They can also check the delivery status of the medical device 80.

[0151] <Management Server> The management server 10 comprises a central control unit 11, a user management unit 20, a medical device management unit 30, a logistics management unit 40, a user database 51, a medical device database 52, and a server-side reader / writer 55.

[0152] <Controller> The central control unit 11 manages the management server 10 and controls communication with external devices (in this case, user terminals 70 and medical devices 80) via the network 2.

[0153] <User Management Device> The user management device 20 functions as a payment processing unit (EC management unit). Specifically, the user management device 20 acquires and updates the contents of subscription contracts and manages users to whom medical devices 80 are delivered, such as dialysis patients 99, dialysis facilities, and agents. In other words, the user management device 20 manages contracts for dialysis patients 99, manages and updates patient information (also called user information or user data), and manages and updates user inventory and usage history of medical devices 80 for each dialysis patient 99. The user management device 20 provides a website for concluding, updating, and confirming contracts with medical institutions and dialysis patients 99. Dialysis patients 99 and others access this website to register contract terms (specifications of subscription-covered dialysis indwelling needle sets 80x and dialyzers 80d, delivery cycle, payment terms, etc.) and patient information. Patient information and contract terms are recorded and updated in the user DB 51. Specific examples of patient information will be described later in Figure 35. Furthermore, the user management device 20, as part of its payment processing unit (EC management unit) functions, handles payment processing with businesses that provide dialysis indwelling needles sold to patients under subscription contracts, payment processing with medical institutions, and payment processing with logistics companies that transport dialysis indwelling needles.

[0154] <Medical device management system> The medical device management device 30 manages the manufacturing of medical devices 80 and their use by dialysis patients 99. Information about medical devices 80 (also called medical device information or medical device data) is recorded and updated in the medical device DB 52. It also registers and manages the medical devices 86 (e.g., dialysis machine 86a, cleaning device 86b) used by dialysis patients 99 when they use medical devices 80. Specific examples of medical device data will be described later in Figure 36.

[0155] <Logistics management equipment> The logistics management device 40 manages the manufacturers and supply chain (manufacturing, shipping, and distribution) of medical devices 80. The logistics management device 40 has the functions of both a factory management department and a supply chain management department.

[0156] The Factory Management Department functions as a factory management department that manages the manufacturing (including ordering materials) and shipment (logistics) of indwelling needles provided to users (patients) who have entered into subscription agreements, based on the usage history and cleaning history of indwelling needles and contract information related to subscription agreements managed by the User Management Department. The logistics management device 40 has the function of automatically ordering the amount of materials to be used in the manufacture of the total number of indwelling needles to be provided to all users in the next supply, and providing a schedule for procurement, manufacturing, and shipping to the factory. The function of the supply chain management department is to provide users with subscription contracts with information on the date of provision of indwelling needles to the users under a subscription contract, the delivery destination and provision date of the user, the volume of goods to be requested from the logistics company (logistics business or delivery company), and the collection and dispatch schedule of the indwelling needles to the factory or shipping facility, based on the usage history and cleaning history of the indwelling needles and the contract information related to the subscription contract managed by the user management device 20.

[0157] Furthermore, the logistics management device 40 has a function to perform customs clearance processing over the network when exporting medical devices 80 overseas. That is, for the delivery of medical devices 80 to dialysis patients 99 overseas, customs clearance processing is completed over the network at the stage of shipment from the factory 90 (or warehouse 91). To this end, by introducing and digitizing a business system on the management server 10 that has an API for linking with NACCS (Nippon Automated Cargo and Port Consolidated System), a system for processing procedures with customs and other related administrative agencies and related private businesses online for ships and aircraft entering and leaving ports in Japan and for cargo being exported and imported, not only export procedures but also customs clearance procedures at the destination are simplified. In addition, by attaching the information written to the RFID 81 to the customs clearance documents, even if physical verification work is required due to random inspections, the cargo can be read and verified with a designated reader, suppressing unnecessary work and enabling smooth customs clearance processing.

[0158] <Server-side reader / writer> The server-side reader / writer 55 is installed in the factory 90 (warehouse 91), etc., and writes predetermined medical device information and patient information to the RFID 81 of the medical devices 80 to be shipped, and records this information in the user DB 51 and medical device DB 52.

[0159] <Patient information database in the user database> Figure 35 shows an example of patient information D10 recorded in user DB51. User information D10 includes basic user information D11, contract information D12, and history information D13.

[0160] User basic information D11 records ID, name, authentication method, address, phone number, email address, payment method, and shipping address. Here, the ID is "01234abc", the name of dialysis patient 99 is "xxxxxx", the authentication method is the password "XXXXXXXX", the address is "Naha City, Okinawa Prefecture, Japan xxx...", the phone number is "098-866-xxxx", the email address is "abcd1234xxx@xxx.xx.jp", the shipping address is "Naha City, Okinawa Prefecture (home)", and the payment method is bank transfer "xxx Bank account number xxx-yyy...", "credit card number", "QR code or other code", or "payment method linked to facial recognition".

[0161] Contract information D12 records which medical devices 80 are to be purchased on a regular basis. Here, the "Reuse Type A, Dialysis 3 Times a Week" type is selected as the dialysis set. This Reuse Type A includes a single indwelling needle set (TYPE: A123, Manufacturer: Company A) and a dialyzer (TYPE: D001, Manufacturer: Company D). The single indwelling needle set of Reuse Type A corresponds to the dialysis indwelling needle set 80x shown in Figure 1, etc., which has an RFID 81 attached to the indwelling needle 100 (needle part 200, main body part 400, partition plate 300, puncture needle 900). Contract information D12 may also include other information such as the timing of delivery (delivery day) and the number of items in the user's inventory. Medical devices 86, such as hemodialysis machines, peritoneal dialysis machines, and reverse osmosis purified water production equipment (reverse osmosis equipment), are delivered at the start of the contract and can be used at a fixed price until the end of the contract period.

[0162] In the history information D13, for each medical device 80 shipped to dialysis patients 99, the status at the factory 90 (warehouse 91), the logistics status, and the user status after delivery to the user, the dialysis patient 99, are recorded. Here, for example, the components of the reused dialysis indwelling needle set 80x, namely the needle part 200 with management number "A12345-01-1", the main body part 400 with management number "A12345-02-1", the partition plate 300 with management number "A12345-03-1", and the puncture needle 900 with management number "A12345-04-1", have the following statuses: factory status "Shipped 3 / 30", logistics status "Delivered 4 / 2", user status usage dates and times "5 / 1 18:30-22:30, 5 / 3 18:45-22:45, 5 / 5 20:00-24:00" and cleaning dates and times "5 / 1 22:45-, 5 / 3 23:00-, 5 / 6 00:15-". Additionally, the expiration date (year, month, and day) is recorded below the management number, and the device is managed to prevent use beyond this date. For the puncture needle 80a with management number "A12345-01-1", the expiration date is "2019 / 06 / 30", and the medical device 86 controls the dialysis indwelling needle set 80x so that it cannot be used after "2019 / 07 / 01" based on RFID sensing 81.

[0163] <Medical device information from the medical device database> Figure 36 shows an example of medical device information recorded in the medical device database 52. The medical device database 52 records the management number, expiration date, factory status, logistics status, contracted patient's user ID, and user status for each product type. Here, a dialysis indwelling needle set 80x is shown, and for example, medical device 80 (needle part 200) with management No. A12346-01-1 has a factory status of "4 / 1 shipped", a logistics status of "4 / 3 delivered", and a user ID of "9321uvw". Furthermore, the user status shows usage dates and times as "4 / 15 13:30-17:30, 4 / 17 14:45-18:45, 4 / 19 14:00-18:00, 4 / 22 14:15-18:15, 4 / 24 14:00-18:00" and cleaning dates and times as "4 / 15, 4 / 17, 4 / 19, 4 / 22". In this case, the usage status is recorded for 5 days. If the usage limit for this dialysis indwelling needle set 80x is 5 times, then from this record, it can be seen that medical device 80 (needle part 200) with management No. A12346-01-1 was discarded because it exceeded its usage limit.

[0164] <Example of delivery process for dialysis indwelling needle sets> Figure 37 is a flowchart of an example of the delivery process for a dialysis indwelling needle set 80x. The user management device 20 checks the usage status of the medical device 80 by the user, a dialysis patient 99, once a day by referring to the user DB 51 (S11). Based on the usage status, the user management device 20 determines whether it is time to manufacture the medical device 80 (S12), and if it is time to manufacture (Yes in S12), it performs the manufacturing process for the medical device 80 corresponding to the manufacturing time (S13).

[0165] If the manufacturing process is complete (S13) or it is not the manufacturing timing (No. in S12), the user management device 20 determines whether it is the delivery timing (S14). If it is the delivery timing (Yes in S14), it processes the delivery of the relevant medical device 80 to the contracted dialysis patient 99 (S15). After delivery, the logistics status is checked, and upon receiving notification that the device has been delivered to the dialysis patient 99, the delivery completion process is performed and the status changes to delivered (S16).

[0166] Figure 38 is a flowchart illustrating an example of the process of reading / writing the usage history of a dialysis indwelling needle set 80x using RFID 81. When a dialysis patient 99 uses the dialysis indwelling needle set 80, the dialysis machine 86a reads the RFID 81 of the dialysis indwelling needle set 80x with the connected user-side reader / writer 85 (S21) and checks the number of uses and the expiration date (S22). At this time, user verification may be performed to determine whether the use is by the correct user.

[0167] If the usage period is within the limit and the number of uses is within the specified limit (Yes in S23), the dialysis machine 86a writes the usage history to the RFID 81 using the user-side reader / writer 85 (S24) and notifies the management server 10 via network 2 (S25). The management server 10 then reflects the usage history in the user DB 51.

[0168] If the expiration date or number of uses has been exceeded (No. in S23), the dialysis machine 86a will warn the user of this fact and instruct them to use a different dialysis indwelling needle set 80x (S26). In principle, the dialysis indwelling needle set 80x that has been warned about cannot be used. Furthermore, if it can be determined from the usage history and cleaning history that the cleaning device 86b has not been used since the last use, the machine may also warn the user to use a different dialysis indwelling needle set 80x.

[0169] Figure 39 is a flowchart showing an example of the process of reading / writing the cleaning history of a dialysis indwelling needle set 80x using RFID 81.

[0170] After completing hemodialysis, the dialysis indwelling needle set 80x used by the dialysis patient 99 is cleaned in the cleaning device 86b. When the dialysis indwelling needle set 80x is placed in the cleaning device 86b, the cleaning device 86b reads the RFID 81 of the dialysis indwelling needle set 80x (S31) and checks the number of uses (S32). If it is within the usage limit (No in S33), the cleaning device 86b performs the cleaning process (S34), writes the cleaning history to the RFID 81 if it is rewritable (S35), and notifies the management server 10 (S36). If the usage limit has been exceeded (Yes in S33), a warning lamp or display indicates that the dialysis indwelling needle set 80x should be discarded (S37). In addition, if multiple dialysis indwelling needle sets 80x are being cleaned simultaneously in the same cleaning device 86b at a dialysis facility, the device may also notify which dialysis indwelling needle set 80x is to be discarded.

[0171] The Supply Chain Management Department has a system that, based on the usage and cleaning history of the indwelling needles and the contract information related to the subscription contract managed by the User Management Department, provides the user with the date on which the indwelling needles will be provided, the delivery address of the user, the date on which the indwelling needles will be provided, the quantity to be requested from the logistics company, and the schedule for collection and dispatch of the indwelling needles to the factory or shipping facility.

[0172] <Summary of Medical Device Management System 1> In this embodiment, the medical device management system 1 introduces the concept of IoT (Internet of Things) to the delivery management of medical devices 80. A traceable RFID 81 is attached to the medical devices 80, and the system predicts and optimizes product inventory, user inventory, and logistics of medical devices 80 according to the usage status of medical devices 80 by dialysis patients 99, thereby eliminating waste and delivering only what is needed, in the necessary quantities, and at the necessary time. This significantly reduces the amount of medical devices 80 that are discarded. Furthermore, the procurement of medical devices 80 can also be automated by the system. More specifically, the following benefits can be gained for dialysis patients, healthcare facilities, and medical device manufacturers.

[0173] (1) 99 benefits for dialysis patients By managing their own reusable dialysis indwelling needle sets 80x, dialysis patients 99 can ensure safety even with reusable needles through the medical device management system 1. Specifically, because the usage history and cleaning history can be properly tracked with RFID 81-equipped medical devices 80, even medical devices 80 that were previously intended for disposability can be reused. In particular, while conventional reuse raised concerns about infection due to the reuse of medical devices 80 used by others, such concerns are eliminated because dialysis patients 99 reuse their own medical devices 80 and do not use medical devices 80 used by others. Furthermore, contracts can be concluded to ensure reliable delivery, and counterfeit needles cannot be used. In addition, by using the optimal dialysis indwelling needle set 80x, the deterioration of the dialysis patient's shunt can be suppressed, reducing the number of vascular repairs required. This significantly reduces the physical burden on the dialysis patient 99 and avoids the incurrence of health insurance costs due to repairs.

[0174] (2) Advantages for medical device manufacturers Traditionally, medical device manufacturers, in principle, have no further involvement once they have delivered the product until the next order is placed. In reality, medical institutions do not always use medical devices with expiration dates within that timeframe. In some cases, they are discarded after expiring. The system will allow medical device manufacturers to manage the process all the way to the point where the devices are discarded without being used. Specifically, (a) the system will be able to identify items approaching their expiration date and prompt medical institutions to take appropriate action, thereby reducing waste. It will become easier to control the number of items delivered and the usage status of customers to avoid discarding them, thereby allowing manufacturers to control production volume. As a result, raw material procurement costs and factory operating costs can be reduced. (b) Subscription contracts with patients and medical institutions will enable planned production at the factory. In the medical industry, due to its characteristics (i.e., from the perspective of patient needs, orders and inventory at medical institutions, and orders and production at the manufacturer's side), it has been thought that subscription contracts for medical devices are not suitable, except for commoditized items such as contact lenses and supplements. In particular, a subscription contract in which patients (in this case, dialysis patients 99) contract for medical devices 80 used in medical procedures (medical processes) had not been anticipated. However, by managing three points in the medical device management system 1—the usage status (including the number of times) of the medical devices 80 subject to the subscription contract (for example, the dialysis indwelling needle set 80x mentioned above), the condition management of the medical devices 80 based on usage and cleaning status (the condition of the needle tip of the dialysis indwelling needle set 80x with RFID 81), and the contract status—production and post-shipment management can be grasped from the contract details. As a result, the factory 90 can achieve significant efficiency improvements and cost reductions across the entire range of production, from production volume adjustment and planning to raw material procurement costs and planning, inventory management, and personnel costs in production. In addition, a detailed annual production schedule can be planned, leading to stable factory operation. Furthermore, as the number of contract holders increases, the number of shipments increases quantitatively, resulting in a significant improvement in profits through factory operation planning. In other words, by using a subscription contract for medical devices 80, the accuracy of planned quantitative production is increased, and by using the management server 10 to count the number of times each dialysis patient uses the devices 99, final production and inventory adjustments can be made more precise.

[0175] (3) Benefits for medical institutions Subscription contracts and reuse can lower procurement costs. When the medical fee system under public health insurance applies, there are restrictions on the conditions for medical fee claims, which can limit the amount that can be claimed, leading to increased costs and sometimes preventing the achievement of appropriate profits. However, by controlling procurement volume and simplifying procurement methods, it is possible to reduce not only the cost of the product itself but also the labor costs for managing it. In addition, it is possible to reduce waste that would otherwise be caused by excess inventory or discarding expired items.

[0176] The present invention has been described above based on embodiments. These embodiments are illustrative, and it will be understood by those skilled in the art that various modifications are possible in the combination of these components, and that such modifications also fall within the scope of the present invention. [Explanation of symbols]

[0177] 100, 1100, 3100 Indwelling needles 200 Needle section (Sheath introducer) 201, Needle channel section 210 Needle Body 211 Guide Section 219 Main body side flow path 220 Needle bottom 221 First Slit 222 Second Slit 229 Needle bottom side channel 250 Blood withdrawal section 260 Blood return department 270 In-flow channel housing 300 Partition plate (partition component) 301, 1301, 3301 Partition Plate Body 302 Base 305 cartridge 400 Main body 401 Accommodation Unit 410 1st connection part 420 2nd connection part 450 Mounting opening 500 and 550 Hemostatic valves 900 Puncture needle 901 Puncture needle body 911 First hose 912 Second hose 1200 Sheath introducer 1210 and 3210 Sheath body (needle body) 1220 Sheath base 1251 and 3251 Blood drainage part (blood drainage side flow path) 1261 and 3261 Blood return part (blood return side flow path) 1270 Partition plate insertion part (first connection flow path) 1272 and 3272 Blood return side slit 1280 Blood return hose connection part 1281 Second connection flow path 1300 Blood drainage functional part 1302 Blood drainage part base 1370 Third connection flow path 1350 Tip cylinder part 1371 and 3271 Blood drainage side slit

Claims

1. An indwelling needle comprising: a blood withdrawal section inserted into a blood vessel to withdraw blood from the blood vessel and discharge it outside the blood vessel; and a blood return section inserted into the blood vessel and integrally combined with the blood withdrawal section to return the blood that has been withdrawn from the blood vessel back into the blood vessel, A needle portion having a hollow cross-section channel, A partition plate inserted into the flow path of the needle portion, It has, The aforementioned needle portion is A needle body provided on the anterior side and inserted into the blood vessel, A needle base provided on the rear side of the needle body, It has, The partition plate is inserted in place of the puncture needle after the needle portion has been inserted into the blood vessel together with the puncture needle and left in place, thereby dividing the hollow channel in the cross-section of the needle portion into two channels: the channel for blood withdrawal and the channel for blood return. Indwelling needle.

2. The needle base portion is A blood drainage opening that connects the flow path of the blood drainage section to the outside, The aforementioned blood return section has an opening for returning dialysis blood to the outside, It has, The main body portion houses the needle base portion of the needle portion, and when the partition plate is inserted through the needle portion, the partition plate is inserted before the needle portion. The main body has a housing section formed in the shape of a bottomed cylinder, The housing portion, with the needle base housed within it, has a first connecting portion that communicates with the blood withdrawal opening and a second connecting portion that communicates with the dialysis blood return opening. The first connecting portion connects to an external first hose, and the second connecting portion connects to an external second hose. The indwelling needle according to claim 1.

3. The inner diameter of the needle body at a certain position in the extending direction is greater than or equal to the inner diameter at the tip side of that position, and at least a portion of it has an inner diameter widening section that gradually widens from the tip side to the base side. The widened inner diameter portion has a tapered shape in a region of 80% or more of the length of the needle body. The indwelling needle according to claim 2, wherein the taper ratio of the tapered shape is 1% or more and 3% or less within the effective length of the subcutaneous insertion range in the widened inner diameter portion.

4. The portion of the partition plate that is housed in the needle body is provided at a position that, when housed in the needle body, becomes the maximum inner diameter in the cross-section of the flow path presented by the needle body, according to any one of claims 1 to 3.

5. The portion of the partition plate that is housed in the needle body is provided at a position offset from the center of the cross-section of the flow path presented by the needle body, according to any one of claims 1 to 3.

6. The indwelling needle according to claim 2, wherein the needle portion and the main body portion are configured to be connected and separated multiple times.

7. The partition plate, while housed in the needle body, is positioned so as to be offset from the center of the flow path cross-section toward the flow path side of the blood return section. The indwelling needle according to claim 5, wherein in the needle portion, the cross-sectional area of ​​the flow path of the blood withdrawal portion is wider than the cross-sectional area of ​​the flow path of the blood return portion.

8. The tip of the needle portion has a blood-withdrawal side slit that connects the blood-withdrawal section's flow path to the outside, and a blood-return side slit that connects the blood-return section's flow path to the outside, in a state where the blood-withdrawal section's flow path and the blood-return section's flow path are separated by the partition plate. The blood withdrawal slit is positioned forward of the blood return slit, with reference to the extension direction of the needle portion. The indwelling needle according to claim 1, wherein the blood withdrawal slit and the blood return slit are provided within 25 mm from the tip of the needle portion.

9. The area of ​​the blood withdrawal side slit is greater than or equal to the cross-sectional area of ​​the tip of the blood withdrawal side channel. The indwelling needle according to claim 8, wherein the area of ​​the blood return side slit is greater than or equal to the cross-sectional area of ​​the tip of the blood return side flow path.

10. The main body is, When either the puncture needle or the partition plate is selected and inserted into the needle portion, a fixing connection portion is provided to fix the inserted member, The main body has a hemostatic valve that ensures a liquid-tight seal between the inside and outside of the main body when the puncture needle or the partition plate is fixed to the fixed connection portion. The indwelling needle according to claim 2 or 3, wherein the hemostatic valve is detachable from the main body.

11. The partition plate is connected to the rear of the main body when the partition plate is inserted into the partition plate insert, and is configured to allow the hemostatic valve to be inserted through it. The indwelling needle according to claim 10, wherein the tip of the partition plate inserter is configured to be inserted through the hemostatic valve and stopped when exposed on the opposite side, and in that state the partition plate is fed out from the opening of the tip of the partition plate inserter and positioned inside the flow path of the needle portion.

12. The indwelling needle according to claim 11, wherein the partition plate insert is configured to be separable from the partition plate when the partition plate is positioned on the needle portion, and to be removable from the main body portion after being separated from the partition plate.

13. A sheath introducer is inserted into the blood vessel, It has a blood withdrawal function unit having a partition plate body, which is attached to the sheath introducer so as to insert the partition plate into the inside of the sheath introducer, The sheath introducer and the blood withdrawal function unit are detachable. The aforementioned sheath introducer is The sheath body is a hollow tube that is inserted into the blood vessel from the tip, A sheath base provided on the rear side of the sheath body and having a first connecting channel connected to the blood drainage function section, It has, The aforementioned sheath base is, The blood return hose connection part to which the blood return hose connected to the dialysis machine is connected, A second connecting channel is provided, which is in communication with the blood return hose connection and connects to the tube of the sheath body, The partition plate insertion section through which the partition plate body is inserted, A hemostatic valve provided on the rear side of the partition plate insertion portion, Having The aforementioned blood drainage function unit is The partition plate body and, The blood drainage section base is provided at the rear end of the partition plate body, It has, The base of the blood withdrawal portion is, The blood withdrawal hose connection part to which the blood withdrawal hose leading to the dialysis machine is connected, A third connecting channel is provided, which is in communication with the blood withdrawal hose connection and has an opening near the extension source of the partition plate body, It has, The sheath introducer is inserted into a blood vessel and left in place after the puncture needle has been inserted into it through the partition plate insertion portion and the hemostatic valve. After the puncture needle is removed and the partition plate body is attached in place of the puncture needle, the partition plate body is inserted into the tube of the sheath body through the partition plate insertion portion and the hemostatic valve, and in this state, the partition plate body divides the inside of the tube into two channels, a blood withdrawal channel and a blood return channel, the blood withdrawal channel is connected to the first connecting channel, the first connecting channel is connected to the third connecting channel, and the blood return channel is connected to the second connecting channel, in this indwelling needle.

14. The indwelling needle according to claim 13, wherein, with the sheath introducer attached to the blood withdrawal function unit, the tip of the partition plate body has a tip tube portion that protrudes by a predetermined length from the tip of the sheath body and communicates the blood withdrawal side flow path with the inside of the blood vessel.

15. The aforementioned tip section has a blood withdrawal slit, The sheath body, in a state where it is divided into the blood withdrawal side channel and the blood return side channel by the partition plate body, has a blood return side slit that connects the blood return side channel to the outside, The blood withdrawal slit is positioned forward of the blood return slit, with reference to the extension direction of the sheath body. The indwelling needle according to claim 14.

16. The sheath body, when partitioned by the partition plate body into the blood withdrawal side channel and the blood return side channel, has a blood withdrawal side slit that connects the blood withdrawal side channel to the outside, and a blood return side slit that connects the blood return side channel to the outside, The blood withdrawal slit is positioned forward of the blood return slit, with reference to the extension direction of the sheath body. The indwelling needle according to claim 13.

17. The indwelling needle according to claim 16, wherein the blood return slit is provided within 20 mm from the tip of the sheath body.

18. The indwelling needle according to claim 1 or 2, further comprising an IC tag provided on at least one of the needle body, the needle base, or the partition plate.

19. A read / writer for reading and writing information from the IC tag attached to the indwelling needle described in claim 18, A database for recording information about the indwelling needle and information about the patient using the indwelling needle, Based on the information from the IC tag, a usage management unit manages the use of the indwelling needle, Equipped with, The reed writer is attached to the indwelling needle cleaning device, and the medical device management system reflects the cleaning history of the indwelling needle by the cleaning device in the database.

20. The medical device management system according to claim 19, wherein the reed / writer is attached to the indwelling needle cleaning device, and the cleaning history of the indwelling needle by the cleaning device is reflected in the IC tag.

21. The medical device management system according to claim 20, wherein the read / writer is attached to a dialysis machine that performs dialysis using the indwelling needle, and acquires information from the IC tag when performing dialysis and reflects the usage history of the indwelling needle in the database.

22. The medical device management system according to claim 20, wherein the usage management unit permits dialysis using the indwelling needle when the usage history of the indwelling needle is within a preset range suitable for reuse.

23. The medical device management system according to claim 20, wherein the usage management unit determines from the usage history and cleaning history of the indwelling needle that it has not been cleaned since the last use, and if it determines that the indwelling needle has not been cleaned, it does not permit dialysis using the indwelling needle.

24. The medical device management system according to claim 20, further comprising a supply management unit that manages the supply of the indwelling needle based on the information of the IC tag.

25. The medical device management system according to claim 20, further comprising a user management unit that manages a subscription contract relating to the indwelling needle with the patient or a medical institution used by the patient.

26. The aforementioned user management unit has a payment processing unit, The medical device management system according to claim 25, wherein the settlement processing unit performs the following: processing of applications for new contracts relating to the subscription contract; settlement processing for the subscription contract; settlement processing with a business operator that provides dialysis indwelling needles to be sold to the patient in the subscription contract; settlement processing with the medical institution; and settlement processing with a logistics operator that transports the dialysis indwelling needles.

27. The medical device management system according to claim 25, further comprising a logistics management unit that manages the manufacturing and shipment of the indwelling needles provided to users who have entered into the subscription agreement, based on the usage history and cleaning history of the indwelling needles and the contract information relating to the subscription agreement managed by the user management unit.

28. The aforementioned Logistics Management Department A medical device management system according to claim 27, which, based on the usage history and cleaning history of the indwelling needle and the contract information relating to the subscription contract managed by the user management unit, notifies the user of the date on which the indwelling needle will be provided to the user under the subscription contract, the delivery address of the user, the date on which the indwelling needle will be provided, the quantity of goods to be requested from the logistics company, and the schedule for collection and delivery of the indwelling needle to the factory or shipping facility via a network.

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