WO2008035422A1 - Joint pour outils médicaux et instrument médical - Google Patents

Joint pour outils médicaux et instrument médical Download PDF

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Publication number
WO2008035422A1
WO2008035422A1 PCT/JP2006/318750 JP2006318750W WO2008035422A1 WO 2008035422 A1 WO2008035422 A1 WO 2008035422A1 JP 2006318750 W JP2006318750 W JP 2006318750W WO 2008035422 A1 WO2008035422 A1 WO 2008035422A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
tube
medical
joint
hollow tube
Prior art date
Application number
PCT/JP2006/318750
Other languages
English (en)
Japanese (ja)
Inventor
Takatoshi Kitagawa
Yoshihiro Hatanaka
Original Assignee
Asahi Kasei Kuraray Medical Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Asahi Kasei Kuraray Medical Co., Ltd. filed Critical Asahi Kasei Kuraray Medical Co., Ltd.
Priority to PCT/JP2006/318750 priority Critical patent/WO2008035422A1/fr
Publication of WO2008035422A1 publication Critical patent/WO2008035422A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/1055—Rotating or swivel joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • the present invention relates to a medical device joint and a medical device for liquid-tightly connecting a liquid port of a medical device and a medical tube.
  • Medical devices used for extracorporeal circulation treatment of bodily fluids typified by blood and plasma, such as human kidney, hemofiltration dialyzer, blood filter, plasma component separator, plasma separator, leukocyte remover,
  • a blood component adsorber or the like has one or more liquid ports for circulating body fluids and passing water and aqueous solutions.
  • these fluid ports allow a physiological solution to flow for priming medical devices and collecting bodily fluids, circulate bodily fluids themselves, or flow dialysis fluids. Used to do.
  • Patent Document 1 discloses a joint for a blood purification apparatus for connecting a tube end to a blood side port of the blood purification apparatus.
  • the inner cylinder member is pressed against the opening cylinder part by the stopper part to make it liquid-tight, and only the outer cylinder member is rotated to form the screw shape formed on the outer peripheral wall on the inner peripheral wall of the outer cylinder part. Since the joint can be connected to the port by screwing it into the formed screw shape, the tube does not remain twisted when the joint is rotated, and the tube is not twisted.
  • Patent Document 2 it is easy to plug and unplug, when it does not come into direct contact with the liquid port during sealing and unplugging, and when the internal pressure of the container increases during sterilization or transportation. In addition, it is possible to completely prevent the internal liquid from leaking out due to a plug removal etc.
  • a device's liquid port sealing structure and a medical device having such a sealing structure are described.
  • a sealing structure for a liquid port of a medical device comprising: a cylindrical wall as a liquid port formed in the medical device; and a plug body sealed in a sealed state on the cylindrical wall.
  • the outer circumferential surface of the cylindrical wall is formed with a ridge in a direction perpendicular to the axis, and the plug body is composed of a top plate and a cylindrical body connected to the top plate, and is sealed on the back surface of the top plate.
  • a cylindrical sealing body to be inserted in a sealed state is integrally formed on the inner peripheral surface of the cylindrical wall at the time of stopping, and a receding thin portion for allowing the protrusions to easily enter the inner peripheral surface of the cylindrical body.
  • a sealing structure for a liquid port of a medical device in which a concave groove is formed in which a protruding line that has entered the thin portion enters when the plug is rotated for sealing. Yes.
  • Patent Document 1 Japanese Patent Application Laid-Open No. 2004-160214
  • Patent Document 2 Japanese Patent Laid-Open No. 2002-172161
  • Non-Patent Document 1 DRAFT INTERNATIONAL STANDARD ISO / DIS 8637 [ ⁇ 4.4.4, ⁇ 4. 4.5, ⁇ 5.5.5, ⁇ 5.5.6, page 15 ⁇ 3 Figure 3, International Organization for Standardizati on, 2002]
  • the force bra used in dialysis as described in Non-Patent Document 1 is generally made of stainless steel and is not disposable. It was. In addition, some are made of greaves, but usually they are not thrown away, but they must be washed and sterilized before being used again. In addition, these power bras have a problem in that the structure itself is complicated, and therefore it is necessary to perform a careful sterilization treatment to suppress the growth of bacteria, and the cost is inevitably high.
  • force can be used for a port including an open cylindrical portion communicating with the inside and an external cylindrical portion having a thread shape formed on the inner peripheral wall while protruding outward from the open cylindrical portion. Therefore, there is a restriction that the twist generated after being connected cannot be eliminated.
  • Patent Document 2 considers only sealing the liquid in the medical device. Therefore, the structure does not take into account the introduction or derivation of the external liquid. Further, Patent Document 2 has no description or even suggests a structure considering the introduction or derivation of an external liquid. Furthermore, the pressure applied during dialysis and filtration is of course not assumed and there is no description or suggestion.
  • the present invention can be easily attached to and detached from the liquid port of the medical device, and the tube can be freely rotated.
  • the purpose of the present invention is to provide a joint for a medical device that can be tightly connected, has a simple structure, can be used, and can be discarded. Further, the present invention provides a use that can be easily and safely connected to a medical device. The purpose is to provide an instrument.
  • the first configuration of the medical device joint according to the present invention for achieving the above object includes an open cylindrical portion communicating with the inside of the medical device, and an outer peripheral surface of the cylindrical wall of the open cylindrical portion.
  • the force bra portion is a connecting member between the medical device liquid port and the connector portion, the outer tube connectable to the medical device liquid port, the inner tube accommodated in the outer tube, A connecting plate for airtightly connecting the inner wall intermediate portion of the outer cylinder and the outer wall of the inner cylinder, and the medical instrument liquid port side inner peripheral surface of the outer cylinder has a convexity of the medical instrument liquid port; A retracted thin portion for allowing the strip to easily enter, and the outer tube to the medical device When the protrusion is inserted into the liquid port and rotated, a concave groove is formed into which the convex line of the liquid port for the medical device is inserted, and the inner tube is formed on the inner peripheral surface of the cylindrical wall of the liquid port for the medical device.
  • the connector portion is a connecting member between the force bra portion and the tube end portion, and has a hollow tube having a protruding stubber on an intermediate outer side. Has a function of restricting the movement in the insertion direction when the hollow tube is inserted inside the inner tube of the force bra part and liquid-tightly joining the inner tube of the force bra part.
  • One end of the hollow tube has a structure connectable to the tube end portion, and there is a protrusion on the intermediate outer surface of the insertion portion of the force bra portion inside the inner cylinder, which is the other end of the hollow tube.
  • the projections on the outer surface of the middle have a function of rotating and joining in a liquid-tight manner when the hollow tube is inserted into the inner cylinder of the force bra portion, and the locking mechanism includes the connector It is a mechanism for preventing detachment of the part from the force bra part.
  • the second configuration of the medical device joint according to the present invention is the first configuration, wherein the projection on the intermediate outer surface of the hollow tube is a circumferential projection along the outer periphery of the hollow tube. It is characterized by being.
  • the third configuration of the medical device joint according to the present invention is characterized in that, in the first configuration, the protrusion on the intermediate outer surface of the hollow tube is a textured surface.
  • the lock mechanism is inserted into the inner tube of the force bra portion inside the hollow tube.
  • a projection provided on the outer side near the tip of the portion, the projection on the outer side near the tip is the liquid port for the medical device at the tip of the inner cylinder when the hollow tube is inserted into the inner cylinder of the force bra part. It protrudes on the side surface, and has a function of preventing the hollow tube from being detached from the inner cylinder of the turnip portion in the tube side direction.
  • the fifth configuration of the medical device joint according to the present invention is the first to third configurations V, and the lock mechanism is detached from the force bra portion and the connector portion.
  • the locking portion is a prevention member, and a screw is formed on the outer peripheral surface of the outer cylinder of the force bra portion on the tube side, and the locking portion can pass through one end of the hollow tube of the connector portion.
  • the stocker has a cap having a through-hole that cannot be inserted, and a screw that engages with a screw formed on an outer peripheral surface of the tube side of the outer cylinder of the force bra portion on a side wall inner peripheral surface of the cap.
  • a hollow tube of the connector part inserted into the inner cylinder of the force bra part is passed through the through hole of the lock part and rotated with respect to the force bra part while rotating the lock part.
  • the cap presses the stopper of the connector part.
  • a sixth configuration of the medical device joint according to the present invention is the fifth configuration, wherein a protrusion is formed on the top plate of the cap of the lock portion, and the force bra The hollow tube of the connector part inserted inside the inner cylinder of the part is passed through the through hole of the lock part.
  • the protrusion formed on the top plate of the cap presses the stagger of the connector portion.
  • the insertion portion of the hollow tube into the inner cylinder of the force bra portion there is a protrusion on the outer side near the tip of the tube, and when the hollow tube is inserted inside the inner cylinder of the force bra part, the protrusion protrudes on the side of the liquid port for medical devices at the tip of the inner cylinder, It has a function of preventing the empty tube from being detached from the inner cylinder of the turnip portion in the tube side direction.
  • an eighth configuration of the joint for a medical device according to the present invention is the above-described first to seventh configurations, in which the stopper is attached to the side of the liquid port for the medical device of the stopper. There is a circumferential projection for rotating and liquid-tightly joining the inner cylinder.
  • a gasket is fitted to the tube side of the connecting plate of the force bra portion in the first to eighth configurations. It is characterized in that a gasket base is formed.
  • a tenth configuration of the medical device joint according to the present invention is the structure of one end of the hollow tube of the connector portion connected to the tube end portion in the first to ninth configurations.
  • the medical device connected to the tube end portion by the joint for medical device includes: It is selected from human kidney, hemofiltration dialyzer, hemofilter, plasma component separator, plasma separator, ascites filter, and ascites concentrator.
  • the first configuration of the medical instrument according to the present invention is characterized in that the medical device joints of the first to eleventh configurations are configured integrally with the tube end. .
  • a portion excluding the force bra portion of the joint for a medical device having the first to eleventh configurations is integrated with the tube end portion. It is characterized by being composed.
  • the medical device joint according to the present invention it goes without saying when connecting to the medical device. Even after connection, the tube can rotate, so the tube will not twist during operation of the medical device.
  • the medical device joint according to the present invention can have two or three parts, and can be manufactured at low cost because of its simple structure. Further, by using the medical device joint according to the present invention, a medical device that can be easily and safely connected to the medical device can be produced.
  • FIG. 1 is a side view illustrating a state in which a medical device joint according to the present invention is connected to a liquid port of a medical device.
  • FIG. 2 is a side view illustrating that the medical device joint according to the present invention includes three parts, a force bra part, a connector part, and a lock part.
  • FIG. 3 is a side view illustrating that the joint force for a medical device according to another embodiment of the present invention is composed of three parts, a S force bra part, a connector part, and a lock part.
  • FIG. 4 (a) is an external side view of the joint for medical devices according to the present invention, and (b) is a cross-sectional side view taken along the line DD of (a).
  • FIG. 5 (a) is a partial cross-sectional side view for explaining a state before joining of the medical device joint and the medical device liquid port according to the present invention, and (b) is the medical device joint according to the present invention. It is a partial cross section side view explaining the state after joining with the liquid port for medical devices.
  • FIG. 6 is a cross-sectional view of the joint side force for explaining the state of joining of the medical device joint and the medical device liquid port according to the present invention.
  • FIG. 7 (a) to (c) are a top view, a side view and a bottom view of the force bra part, and (d) is a cross-sectional side view taken along the line BB of (a).
  • FIG. 8 (a) to (c) are a top view, a side view and a bottom view of the connector part, and (d) is a cross-sectional side view taken along the line CC of (b).
  • FIG. 9 (a) to (c) are a top view, a side view, and a bottom view of another embodiment of the connector portion, and (d) is a cross-sectional side view taken along the line FF of (b).
  • FIG. 10 (a) to (c) are a top view, a side view, and a bottom view of the lock part, and (d) is a cross-sectional side view taken along line AA of (a).
  • FIG. 6 is a side view illustrating a connection state between a medical device joint and a medical device having a structure of a medical tube end connected to the medical device joint of IS 0594-1 and a liquid port of the medical device.
  • FIG. 12 (a) to (c) are a top view, a side view, and a bottom view of a connector portion in which the hollow tube end structure on the medical tube connection side is IS0594-2.
  • (D) is a view of (a).
  • FIG. 13 (a) to (c) are a top view, a side view and a bottom view of the connector part of another embodiment in which the hollow tube end structure on the medical tube connection side is IS0594-2, (d) It is a GG line section side view of (a).
  • FIG. 14 (a) is a partial cross-sectional side view illustrating a state before joining of a medical device joint and a medical device liquid port where the hollow tube end structure on the medical tube connecting side of the connector is IS0594-2
  • FIG. 4B is a partial cross-sectional side view for explaining a state after joining a medical device joint and a medical device liquid port in which the hollow tube end structure on the medical tube connecting side of the connector portion is IS05 942 is there.
  • FIG. 15 is a side view illustrating that the joint force S for the medical device according to another aspect of the present invention is composed of two parts, a S force bra part and a connector part.
  • FIG. 16 is a side view for explaining that the medical device joint according to still another aspect of the present invention is composed of two parts, a force bra part and a connector part.
  • the medical device joint and the medical device tube are in a posture in which the medical device is positioned with the medical device liquid port facing up. Is the vertical direction when connected.
  • the “tube side” of the force bra part, connector part, or lock part of the joint for medical equipment means that the tube is connected when the joint is connected to the liquid port of the medical equipment and the tube of the medical equipment.
  • the “liquid port side” refers to a portion closer to the liquid port. Therefore, in the present invention, “upper” means “tube side” and “lower” means “liquid port side”.
  • the medical device 10 to which the present invention is applied is a medical device 10 used for extracorporeal circulation treatment of a bodily fluid represented by blood or plasma.
  • a medical device 10 used for extracorporeal circulation treatment of a bodily fluid represented by blood or plasma.
  • an artificial kidney blood Examples thereof include a filtration dialyzer, a hemofilter, a plasma component separator, a plasma separator, an ascites filter, and an ascites concentrator.
  • Such a medical device 10 can be used for medical purposes by the medical device joint 60 according to the present invention. Connected to tube end 14.
  • a medical device fluid port performs extracorporeal circulation treatment of a body fluid
  • a physiological solution is flowed to collect the body fluid
  • a body fluid itself is circulated, or a dialysis fluid is flowed.
  • the fluid port for medical devices is accompanied by the inflow and outflow of fluid such as body fluid, and the connector connecting the medical device liquid port and the medical tube has high pressure-tightness. Therefore, the medical device joint 60 according to the present invention is preferably used.
  • a medical device 10 is, for example, an artificial kidney in which a hollow fiber or the like is accommodated, and an inflow port 11 and an outflow port 12 for blood or the like in the axial direction (longitudinal direction) of the medical device 10
  • An inflow port 21 and an outflow port 22 for other fluids such as dialysate are provided on the peripheral surface in the vicinity of both ends of the cylinder.
  • a conventionally known cap 13 is detachably attached to the inflow port 11 and the outflow port 12, and the inflow port 21 and the outflow port 22 that are liquid ports for medical devices are connected to the medical device joint 60 according to the present invention. Is crowned in close contact.
  • the inflow port 21 and the outflow port 22 are configured in the same shape, and the same medical device joint 60 to be covered therewith is used. Therefore, in the following description, an example in which the medical device joint 60 is crowned on the inflow port 21 will be described as an example of the medical device liquid port.
  • the medical device joint 60 is composed of three parts: a force plastic part 30, a connector part 40, and a lock part 50 constituting a lock mechanism. Assemble as shown. For example, first, the hollow tube small diameter portion 43 of the connector portion 40 is inserted into the inner cylinder 33 of the force bra portion 30, and the lock portion is inserted into the through hole 54 of the lock portion 50 through the hollow tube large diameter portion 41 of the connector portion 40. Just screw in 50.
  • the material for the force plastic part olefin-based materials, polyethylene, polypropylene, etc. are preferred.
  • the lock part 50 constituting the lock mechanism is a detachment prevention member for the force bra part 30 and the connector part 40, and the lock mechanism is a detachment prevention mechanism for the connector part 40 from the force bra part 30.
  • the protrusion provided on the intermediate outer surface of the hollow tube small-diameter portion 43 serving as the insertion portion on the side is basically a conical shape, and has a shape whose width decreases in the height direction. To tell. If the height of the protrusion is too high, the adhesion cannot be maintained and leakage occurs. If the height is too low, the degree of adhesion increases, the resistance increases, and the connector can rotate freely. It becomes impossible to do it. Therefore, the height of the protrusion is 1 ⁇ m or more and 100 ⁇ m or less, preferably 10 ⁇ m or more and 50 m or less.
  • the contact area between the protrusions and the force bra part is advantageously small as the connector part is rotated. Further, in order to increase the degree of adhesion, it is advantageous to arrange the front surface without any gap. The following explains the existence of protrusions that exert an effect of balancing the conflicting performance.
  • Figures 4 (a) and 4 (b) show the appearance and structure of the medical device joint 60 after assembly.
  • the hollow tube is formed on the intermediate outer surface of the small-diameter portion 43 of the hollow tube serving as the insertion portion inside the inner tube 33 of the cover portion 30 of the connector portion 40 formed of a hollow tube.
  • the circumferential protrusion 43a means one that protrudes in a circular shape along the outer peripheral surface of the small-diameter portion 43 of the hollow tube.
  • the number of the circumferential protrusions 43a may be any number as long as it is one or more, but is preferably one, and more preferably two.
  • the circumferential protrusions 43a may not be independent of each other. For example, if the ridges of the circumferential protrusions 43a overlap, the vertices exist independently!
  • the circumferential projection 43a can be in uniform contact with the inner circumferential surface 33b of the inner cylinder 33, as shown in FIG. It may be a circular protrusion 43a having a sharp point. However, if the area where the circumferential protrusion 43a is in contact with the inner peripheral surface 33b of the inner cylinder 33 is too large, it is not preferable because the frictional resistance is increased and the rotational performance is lowered.
  • a hollow tube small-diameter portion 43 that serves as an insertion portion of the force plastic portion 30 of the connector portion 100 formed of a hollow tube into the inner cylinder 33.
  • the outer surfaces 43c and 43d are Each has a rough and dense texture surface, and when inserted into the inner cylinder 33 of the force plastic portion 30, it is joined to the inner peripheral surface 33b of the inner cylinder 33 in a freely rotatable and liquid-tight manner. ing.
  • the protrusions on the intermediate outer surfaces 43c and 43d of the hollow tube small diameter portion 43 of the connector portion 100 to be a hollow tube are formed with a textured surface.
  • wrinkle is a technique for making fine irregularities and is a term generally used in injection molding.
  • the advantage of using a textured surface is that it is relatively easy to achieve both liquid-tightness and rotation without increasing the accuracy of the parts. For example, when using parts that do not have a textured surface, high parts accuracy is required to improve liquid tightness. Finding close contact so that no gap is created increases the frictional resistance and makes rotation difficult. If the accuracy is such that a gap is created, rotation is easy, but liquid tightness cannot be maintained, and liquid leakage occurs.
  • the grain is sprayed with sand of uniform size on the surface of the molding die (sand blasting), or! Is made by applying electrical discharge machining to create fine irregularities on the surface of the molding die with fine scratches.
  • the machining conditions for electrical discharge machining are set based on the state of embossing by sandblasting. Shibo does not have a unified standard such as an industrial standard, and each manufacturer has its own standard, and the standard is determined based on the surface condition of the sample.
  • Factors that control the roughness and depth of the textured surface are the amount of sand to be blown and the pressure at the time of blowing in sandblasting, and the distance from the surface of the discharge electrode to the mold, The moving speed, voltage, and current of the discharge electrode along the surface.
  • the embossing is controlled by the depth of the groove, in other words, by the convex height of the surface of the molded product.
  • Sand used for sandblasting is an abrasive specified by JIS R6001 abrasive particle size.
  • the grain size and depth of the JIS standard have a correlation, and the grain size of the abrasive is determined by determining the groove depth.
  • abrasive grain size # 46 is used for 7 to 10 microns
  • abrasive grain size 14 for 50 microns.
  • the rough and dense states appearing on the surface correlate with the size of the abrasive grains, with shallow grooves having surface dense wrinkles and deep grooves having surface rough wrinkles.
  • the height of the fine protrusions on the surface of the molded product thus formed is 10 microns to 50 microns. About Ron.
  • the height of the convex part of the rough textured surface is 20 to 50 microns, preferably 20 microns and 30 microns.
  • the height of the convex portion of the dense embossed surface is 10 to 30 microns, preferably 10 to 20 microns.
  • the arrangement order of the rough texture surface and the dense texture surface is not particularly limited, but it is more preferable that the stopper 42 side is rough and the end portion side is dense. Further, the ratio of the rough texture surface and the dense texture surface to the outer surfaces 43c, 43d of the hollow tube small diameter portion 43 is not particularly limited. Non-textured surfaces may also be included. Preferably, the proportion of the rough textured surface in the outer surfaces 43c and 43d of the hollow tube small diameter portion 43 is 50%, and the ratio of the dense textured surface is 50%.
  • the dense embossed surface is a force that contributes to improving the liquid tightness between the hollow tube of the connector part 100 and the inner tube 33 of the force plastic part 30.
  • the rotation of the bra part 30 with the inner cylinder 33 works obstructively.
  • the rough textured surface reduces the force-liquid tightness that contributes to improving the pivotability of the hollow tube of the connector portion 100 and the inner tube 33 of the force bra portion 30. Therefore, it is only necessary to select the optimal ratio according to the purpose by changing the ratio of both.
  • circumferential protrusion 43b on the outer side of the inner tube 33 of the inner portion of the inner tube 33 of the force bra portion 30 of the hollow tube small diameter portion 43 to be a hollow tube. Is inserted into the inner tube 33 of the force bra portion 30, the circumferential projection 43 b protrudes on the side of the medical device liquid port at the tip of the inner tube 33 of the force bra portion 30, and the hollow tube The hollow tube small-diameter portion 43 is prevented from detaching from the inner tube 33 of the turnbuckle portion 30 in the tube side direction.
  • a hollow projection 43b provided on the outer side near the front end of the insertion portion to the inside of the inner tube 33 of the force bra portion 30 of the hollow tube small-diameter portion 43 serving as a hollow tube is connected to the force bra portion 30 of the connector portion 40. It is configured as a lock mechanism as a mechanism for preventing detachment from the body.
  • the circular protrusion 43b may have any shape as long as it can prevent the hollow tube small-diameter portion 43 serving as a hollow tube from being separated from the inner tube 33 of the turnbuckle portion 30, but is preferably as described above.
  • This is a circumferential protrusion 43b similar to the circumferential protrusion 43a that protrudes in a circular shape along the outer peripheral surface of the hollow tube small-diameter portion 43.
  • the circumferential protrusion 43b may be omitted.
  • the connector part 40 is composed of independent parts, and this part rotates to connect the medical instrument tube! Even if the tube is restored, the twisting is eliminated by the restoring force of the tube. .
  • the hollow tube large-diameter portion 41 which is one end portion of the connector portion 40 having a hollow tube force, has a structure that can be connected to the medical tube end portion.
  • the connector portion 40 which is a connecting member between the force bra portion 30 and the medical tube end portion 14, has a stopper 42 that protrudes outside the outer peripheral intermediate portion of the hollow tube.
  • the stopper 42 restricts movement in the insertion direction when the connector portion 40 made of a hollow tube is inserted into the inner tube 33 of the force bra portion 30 and is joined to the inner tube 33 of the force bra portion 30 in a liquid-tight manner. It has a function.
  • the degree of joining of the small-diameter side surface 42a of the stopper 42 and the tube side end surface 33c of the inner cylinder 33 of the force plastic portion 30 is important for the liquid tightness between the connector portion 40 and the force plastic portion 30.
  • the small diameter side surface 42a of the stopper 42 and the tube side end surface 33c of the inner cylinder 33 of the force plastic portion 30 are brought into contact with each other, and the large diameter side surface 42b of the stagger 42 is pressed by the lock portion 50 to make it liquid-tight. I can do it.
  • a gasket may be fitted into a gasket base 36 provided on the tube side of the connecting plate 1 of the force bra portion 30 shown in FIG.
  • a circumferential shape (not shown) for joining the stopper 42 to the inner tube 33 of the force bra portion 30 in a rotatable and liquid-tight manner on the side surface 42a of the small-diameter portion serving as the side surface of the liquid port for the medical device of the stopper 42. Protrusions can also be provided.
  • the gasket is a disk-shaped seal, and the material is polytetrafluoroethylene (PTFE) or fluorine-based soot typified by tetrafluoroethylene 'perfluoroalkyl butyl ether copolymer (PFA).
  • PTFE polytetrafluoroethylene
  • PFA fluorine-based soot typified by tetrafluoroethylene 'perfluoroalkyl butyl ether copolymer
  • a material having slidability such as fat or silicone resin is used. As described above, it is possible to keep liquid-tight without using a gasket.
  • the bottom surface of the gasket pedestal 36 of the force plastic part 30 is pulled up to the same height as the tube side end face 33c of the inner cylinder 33 to make it the same plane, and the contact area with the small diameter side surface 42a of the stopper 42 of the connector part 40 Is maximized.
  • the material of the stopper 42 and the tube side end surface 33c of the inner cylinder 33 is important.
  • the stopper 42 must be made of a hard material.
  • the outer peripheral surface of the large-diameter portion 41 of the hollow tube or Acrylonitrile-butadiene-styrene (ABS) resin, hard polyvinyl chloride (hard PVC), which is preferred to be a relatively hard material that can be dissolved in a solvent. ), Polycarbonate resin, etc. are preferred.
  • the material of the tube side end surface 33c of the inner cylinder 33 is preferably a relatively soft material, for example, an olefin-based material, polyethylene, polypropylene or the like.
  • the large-diameter side surface 42b is pressed by the lock portion 50, and the tube side end surface 33c of the inner cylinder 33 and the small-diameter side surface 42a are brought into close contact with each other.
  • the stopper 42 is soft, it is distorted by the pressing force of the lock portion 50, and the degree of adhesion between the tube side end surface 33c of the inner cylinder 33 and the small diameter side surface 42a of the stopper 42 decreases.
  • the stopper 42 is hard, so that a pressing force can be uniformly applied to the entire circumferential surface.
  • the tube side end surface 33c of the inner cylinder 33 uses a soft material to disperse the pressing force. Thereby, the liquid tightness between the small diameter side surface 42a of the stopper 42 of the connector portion 40 and the tube side end surface 33c of the inner cylinder 33 of the force plastic portion 30 may be increased.
  • the small diameter side surface 42a of the stopper 42 is in close contact with the tube side end surface 33c of the inner cylinder 33, if the pivotability of the connector portion 40 is significantly reduced, it is not shown on the small diameter side surface 42a of the stopper 42. Circumferential protrusions may be provided to reduce the contact area and improve the turning performance.
  • the lock part 50 is a member for preventing the detachment between the force plastic part 30 and the connector part 40.
  • the hollow tube large-diameter portion 41 serving as one end of the hollow tube of the connector portion 40 can pass through, but the stopper 42 also has a cap force having a through hole 54 that cannot pass through.
  • a screw 53 is formed on the inner peripheral surface of the side wall of the cap. The screw 53 is screwed to the screw 31 formed on the outer peripheral surface of the outer cylinder 35 of the force plastic portion 30.
  • a protrusion 52 is formed on the inner side of the top plate of the lock portion 50 having a cap force, and the hollow tube of the connector portion 40 inserted into the inner cylinder 33 of the force plastic portion 30 is connected to the through hole of the lock portion 50.
  • the screw 53 formed on the inner peripheral surface of the lock portion 50 and the screw 31 formed on the outer peripheral surface of the outer cylinder 35 of the force plastic portion 30 are screwed together. It is formed like this! It can be right-handed or left-handed!
  • the force bra portion 30 When connecting the fluid port of the medical device 10 and the force bra portion 30, the force bra portion 30 is rotated in the right-handed screw direction, so it is more preferable that the lock portion 50 and the force bra portion 30 are also right-handed. Further, the shape of the present embodiment is not limited as long as the anti-slip 51 is provided around the mouth portion 50 as long as it functions as a non-slip.
  • FIGS. 5 and 6 show the joined state of the medical device joint 60 and the inflow port 21 according to the present invention.
  • the inflow port 21 serving as the liquid port for the medical device has an open cylindrical portion communicating with the inside of the medical device 10, and a protrusion 26 a is formed on the outer peripheral surface of the cylindrical wall 23 of the open cylindrical portion.
  • the medical device joint 60 is used to connect the medical tube end 14 to the inflow port 21 serving as a medical device liquid port.
  • the inflow port 21 has a cylindrical wall 23, a small-diameter portion 24 at the tip, and an annular recess 25 on the base side. This annular depression 25 is used to stabilize the connection by allowing a part of the device to enter when connecting to other devices.
  • a predetermined number of ridges 26a are formed in a body at a position slightly closer to the medical device 10 than the annular depression 25 on the outer peripheral surface of the cylindrical wall 23. In the present embodiment, two ridges 26a are formed.
  • ridge 26a is visible in front, but another ridge 26a is formed on the opposite side (back side) with the cylinder in between (Fig. 6). reference).
  • the ridge 26a is disposed in the same plane perpendicular to the axis of the inflow port 21 and has a rib shape extending in a direction perpendicular to the axis.
  • the annular depression 25 is not essential.
  • the structure of the cylindrical wall 23 formed as a medical device liquid port on the medical device 10 side is arbitrary, and the medical device joint 60 can be crowned and its outer periphery.
  • the ridges 26a are formed on a part of the surface.
  • the ridge 26a may be a cylindrical protrusion, but considering the strength, A rib shape in a direction perpendicular to the axis as shown is preferable.
  • the force bra portion 30 is a connecting member between the medical device liquid port and the connector portion 40, and includes an outer cylinder 32 connectable to the medical device liquid port, and an inner cylinder 33 accommodated in the outer cylinder 32.
  • the intermediate portion of the inner wall of the outer cylinder 32 and the outer wall of the inner cylinder 33 are hermetically coupled by the connecting plate 1.
  • the medical device liquid port side inner peripheral surface 32a of the outer cylinder 32 is an expanded and retracted thin portion 38 for allowing the protrusion 26a of the inflow port 21 to be a medical device liquid port to easily enter 38. Then, when the outer cylinder 32 is fitted into the inflow port 21 serving as a medical device liquid port and rotated, a concave groove 38a into which the ridge 26a of the inflow port 21 enters is formed. A screw 31 is formed on the outer peripheral surface of the outer cylinder 32 on the tube side.
  • the inner cylinder 33 of the force bra part 30 is inserted into the inflow port 21 and the tip of the inner cylinder 33 is inserted.
  • the sealing portion 33a and the inner peripheral surface 27 of the cylindrical wall 23 of the inflow port 21 are in close contact with each other and inserted in a liquid-tight manner.
  • the guide 35a functions to hold the inflow port 21 in place and keep it from moving.
  • a thin portion 38 is formed on the opening side of the inner peripheral surface 32a of the outer cylinder 32 of the force plastic portion 30, and a number corresponding to the ridge 26a of the inflow port 21 with an equal interval therebetween. Only (two in the present embodiment) is formed with ridges 39a.
  • a concave groove 38a is formed between the convex line 39a and the step-shaped guide part 39. The concave groove 38a is formed in a direction perpendicular to the axis of the inflow port 21 and in the same plane perpendicular to the axis.
  • the length of the ridge 39a or the groove 38a is equal to or slightly longer than the length of the ridge 26a of the force bra part 30, and the width of the groove 38a in the axial direction (D-D direction in Fig. 4 (a)) is It is formed to be equal to or slightly wider than the width of the ridge 26a of the force plastic portion 30.
  • the thin portion 38 is an intrusion portion of the ridge 26a of the inflow port 21, and reaches the open end 34 over at least the length of the ridge 26a.
  • the diameter of the imaginary circle connecting the inner peripheral surface of the thin portion 38 is set to be approximately equal to the diameter of the imaginary circle connecting the tip surface of the ridge 26a.
  • the guide portion 39 of the thin portion 38 serves as a guide surface for guiding the ridge 26a to the concave groove 38a.
  • the ridge 26a that has entered the groove 38a cannot be moved in the axial direction by being sandwiched between the ridge 39a of the force bra portion 30 and the guide portion 39.
  • the guide portion 39 extends a predetermined distance in a direction perpendicular to the axis of the inflow port 21, that is, in the horizontal direction, and may be configured to end as a vertical wall in the axial direction.
  • the force bra 30 is covered with the upward force of the inflow port 21 and pressed to the medical device 10 with some force.
  • the inner cylinder 33 of the force bra part 30 is inserted into the inflow port 21, and the tip sealing part 33a of the inner cylinder 33 and the inner peripheral surface 27 of the inflow port 21 are brought into close contact with each other.
  • the open end portion 34 of the force bra portion 30 reaches the position of the ridge 26a of the inflow port 21.
  • the medical device joint 60 is rotated so that the ridge 26a and the thin portion 38 of the force bra portion 30 are opposed to each other.
  • the protrusion 26a of the inflow port 21 enters the thin portion 38.
  • the ridge 26a is slid into the concave groove 38a while being guided by the guide portion 39 of the thin portion 38. Since the concave groove 38a has a closed end portion 37, the rotation stops when one end of the ridge 26a contacts the end portion 37, and the connection between the medical device joint 60 and the inflow port 21 is completed.
  • the entire circumference knurled 32b of the outer cylinder 32 of the force bra portion 30 is picked and rotated clockwise by a predetermined angle so that the ridge 26a becomes a groove 38a.
  • the separation operation is completed simply by pulling up the medical device joint 60 in the axial direction of the inflow port 21.
  • the entire circumferential knurl 32b means that the entire circumferential surface has a jagged shape and is mainly attached as a non-slip to the outer periphery of the round object, but if it has a non-slip function, it is limited to the shape of this embodiment. It's not something.
  • the operation for joining and separating the joint 60 for a medical device can be performed in a state where the outer cylinder 32 of the force bra portion 30 is picked, and there is no possibility of touching the inflow port 21 at all.
  • the medical device joint 60 is made of a relatively hard material, it is easy to connect the medical device joint 60 without causing deformation.
  • the medical device joint 60 does not move freely in the axial direction of the inflow port 21. Absent. Therefore, the internal pressure in the medical device 10 is increased. Even if the temperature rises or the pressure is reduced, the medical device fitting 60 is not inadvertently disconnected or the liquid-tight state is not destroyed.
  • two or more forces that are formed on the outer peripheral surface of the cylindrical wall 23 forming the inflow port 21 may be formed.
  • the load generated between the inflow port 21 and the medical device joint 60 generated at the time of joining can be evenly distributed to more places, and the internal pressure increases greatly as well as at the time of ordinary close joining. In this case, a stable connection state can be maintained even when the pressure is reduced or the liquid-tight state can be more effectively prevented.
  • the structure of one end portion of the hollow tube of the connector portion 40 connectable to the medical tube end portion 14 is IS059 4 —
  • a configuration having a structure based on two standards may be used. That is, as shown in FIG. 12, the end structure of the large-diameter portion 41 of the hollow tube of the connector portion 40 can be based on the IS0594-2 standard. In such a structure, the end of the hollow tube There are protrusions 92, and the inner wall surface of the hollow tube is a tapered surface 91.
  • the structure of the medical tube end portion 14 coupled to the hollow tube of the connector portion 40 having a structure in which one end portion has a structure based on the IS0594-2 standard is IS0594 1
  • the structure is based on a standard, and such a structure is configured with a lock ring 81 and a hollow tube 82, and a screw 81a into which a projection 92 at the end of the hollow tube is screwed inside the lock ring 81. Is formed.
  • the medical device joint 60 may be used as a joint for connecting a medical device and the medical device 10 by sterilizing and wrapping the joint alone, or for a medical device.
  • the joint 60 may be sterilized and packaged integrally with the medical device with the joint 60 connected to the medical device. That is, the medical instrument joint 60 can be a medical instrument configured integrally with the medical tube end 14.
  • a medical instrument in which a portion excluding the force bra portion 30 of the medical device joint 70 is configured integrally with the medical tube end portion 14 may be used.
  • the connector part 40 and the lock part 50 which are a part of the medical device joint 60, may be used by being sterilized and packaged integrally with the medical device in a state where the medical device is connected.
  • the medical device in which the connector portion 40 and the lock portion 50 provided on the medical device joint 60 are integrally formed with the medical tube end portion 14 can be obtained.
  • the medical device refers to an artificial kidney, a blood filtration dialyzer, a blood filter, a plasma component separator, plasma, which are medical devices used for extracorporeal circulation treatment of body fluids typified by blood and plasma. It refers to the blood circuit required when using a separator or the like.
  • the blood circuit includes an arterial line, a venous line, a filtration line, a dialysate line, a replacement fluid line, and the like.
  • the blood circuit is mainly used together with the medical device joint according to the present invention. Dialysate line and replacement fluid line.
  • the filtration line is a tube for draining excess water and components in body fluids from the fluid port of medical devices
  • the dialysate line is for injecting dialysate from a container containing dialysate into the fluid port.
  • the replacement fluid line is a tube for injecting a replacement fluid containing necessary components and water.
  • a medical device which is composed of a force bra portion 30 and connector portions 40 and 100 and does not have the lock portion 50 described above.
  • the force bra part 30 is connected to the lock part 50. It is not necessary to have a function, so the screw 31 on the outer periphery of the force plastic part 30 as shown in Fig. 2 may or may not be present.
  • the joints 60 and 200 for the medical device having the lock part 50 a force that has a good force even if the circumferential protrusions 43b of the connector part 40 and 100 are not present.
  • the protrusion 43b is essential.
  • the structures of the connector portions 40 and 100 of the medical device joints 60 and 200 and the medical device joints 70 and 210 and the force plastic portion 30 may be the same.
  • the feature of medical device fittings 70 and 210 is that the number of parts is only 2 V, which is simpler in structure and more suitable for disposal than medical device fittings 60 and 200.
  • each manufacturer has its own standard for grain, and the standard is determined based on the surface condition of the sample.
  • the rough textured surface (outer surface 43c in Fig. 9) entrusted to Fujita Metal Industry Co., Ltd. is shown in the standard of Fujita Metal Industry Co., Ltd. and is equivalent to RM34.
  • (Outer surface 43d in Fig. 9) corresponds to the sample RM36 shown in the above standard.
  • the molding die was subjected to sanding by the sand blast method.
  • the outer surface 43d which is a dense textured surface of RM36, uses an abrasive with a grain size of # 46 so that the depth is 10 microns
  • the outer surface 43c which is a rough textured surface of RM34, has a depth of 30
  • An abrasive with an abrasive grain size of # 20 was used to achieve a micron.
  • the abrasive was sprayed using a blasting machine (blast cabinet B-3T suction type) manufactured by Atsuji Steel Co., Ltd., with a compressed air pressure of 392.4 kPa and an injection angle of 90 degrees.
  • Medical device 10 generally used for treatment of extracorporeal circulation of body fluids, for example, artificial kidney, blood filtration dialyzer, blood filter, plasma component separator, plasma separator, leukocyte remover, blood component adsorber
  • the equivalent pressure is 400mmHg ⁇ 500mmHg (about 53.3kPa ⁇ 66.7kPa). Therefore, from the above test results, the medical device joints 60 and 200 according to the present invention or the medical device joints 60 and 200 (equivalent to the medical device joints 70 and 210) with the lock 50 removed are used as medical devices. It was shown that it has sufficient pressure resistance.
  • a dial for artificial dialysis APS (manufactured by Asahi Kasei Medical Co., Ltd.) is connected to the joints 70 and 210 for medical devices according to the present invention, and 70 and 210 for medical devices. 50 mm inner diameter 3.4 mm X outer diameter 5. A 1 mm vinyl chloride tube was bonded with an adhesive.
  • the liquid port of the medical device 10 and the medical tube end 14 can be connected in a liquid-tight manner. At this time, or after the connection, the medical tube is not twisted. Also, it does not easily come off the medical device 10. Further, the medical device joints 60 and 200 or the medical device joints 70 and 210 of the present invention can be easily connected to or disconnected from the liquid port by rotating with the force bra 30 so that the liquid port is touched. There is no need, so it is safe.
  • the medical device joints 60 and 200 according to the present invention, and the medical device joints 70 and 210 have a simple structure, so that they can be made into inexpensive disposable products. There is no need for disinfection and it is hygienic and safe.
  • the present invention can be applied to a medical device joint and a medical device for liquid-tightly connecting a liquid port of a medical device and a medical tube.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un joint pour outils médicaux. Ledit joint peut être fixé facilement à un port liquide d'un outil médical et détaché dudit outil, permet le raccordement amovible et hermétique d'un tube destiné à un usage médical, présente une structure simple, et peut être jeté. La présente invention concerne également un instrument médical jetable permettant un raccordement pratique et sûr à un outil médical. En particulier, l'invention concerne un joint (60, 70) pour un outil médical comprenant un coupleur (30), un connecteur (40) et un mécanisme de verrouillage. Ledit coupleur (30) présente un tube externe (32) qui peut être raccordé à un port liquide d'un outil médical, un tube interne (33) qui peut être emballé dans le tube externe (32), et une carte de connexion (1) qui relie hermétiquement la partie intermédiaire de la paroi interne du tube externe (32) à la paroi externe du tube interne (33). Le connecteur (40) comprend un tube creux présentant un butoir en saillie (42) situé dans la partie intermédiaire extérieure, et se raccorde de manière amovible et hermétique lorsqu'il est inséré dans le tube interne (33) du coupleur (30). Le mécanisme de verrouillage est caractérisé en ce qu'il s'agit d'un mécanisme destiné à empêcher le connecteur (40) de se détacher du coupleur (30). La constitution de l'instrument médical est caractérisée en ce que le joint pour les outils médicaux tel que décrit ci-dessus, ou les parties du joint pour outils médicaux excluant le coupleur, sont intégrés à l'extrémité du tube.
PCT/JP2006/318750 2006-09-21 2006-09-21 Joint pour outils médicaux et instrument médical WO2008035422A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2006/318750 WO2008035422A1 (fr) 2006-09-21 2006-09-21 Joint pour outils médicaux et instrument médical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2006/318750 WO2008035422A1 (fr) 2006-09-21 2006-09-21 Joint pour outils médicaux et instrument médical

Publications (1)

Publication Number Publication Date
WO2008035422A1 true WO2008035422A1 (fr) 2008-03-27

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PCT/JP2006/318750 WO2008035422A1 (fr) 2006-09-21 2006-09-21 Joint pour outils médicaux et instrument médical

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WO (1) WO2008035422A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016007890A1 (fr) * 2014-07-10 2016-01-14 Abbvie Inc. Systèmes et procédés pour pose de tube

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0531180A (ja) * 1991-07-26 1993-02-09 Nissho Corp 医療用接続器具
JPH08500983A (ja) * 1992-06-04 1996-02-06 ヴァーネイ ラボラトリーズ インク 医療用カップリング器具
JP2002172161A (ja) * 2000-12-08 2002-06-18 Asahi Medical Co Ltd 医療用具用液体ポートの封止構造及び該封止構造を持つ医療用具
JP2006102255A (ja) * 2004-10-06 2006-04-20 Nippon Sherwood Medical Industries Ltd 輸液ラインの接続構造及びその接続構造を備えたコネクター

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0531180A (ja) * 1991-07-26 1993-02-09 Nissho Corp 医療用接続器具
JPH08500983A (ja) * 1992-06-04 1996-02-06 ヴァーネイ ラボラトリーズ インク 医療用カップリング器具
JP2002172161A (ja) * 2000-12-08 2002-06-18 Asahi Medical Co Ltd 医療用具用液体ポートの封止構造及び該封止構造を持つ医療用具
JP2006102255A (ja) * 2004-10-06 2006-04-20 Nippon Sherwood Medical Industries Ltd 輸液ラインの接続構造及びその接続構造を備えたコネクター

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016007890A1 (fr) * 2014-07-10 2016-01-14 Abbvie Inc. Systèmes et procédés pour pose de tube
AU2015287641B2 (en) * 2014-07-10 2020-03-19 Abbvie Inc. Systems and methods for tubing delivery
US10744069B2 (en) 2014-07-10 2020-08-18 Abbvie Inc. Systems and methods for tubing delivery
US10806679B2 (en) 2014-07-10 2020-10-20 Abbvie Inc. Systems and methods for tubing delivery
EP3912615A1 (fr) * 2014-07-10 2021-11-24 AbbVie Inc. Systèmes et procédés de livraison de tubulures

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