JP5860299B2 - Blood purifier plug - Google Patents

Description

  The present invention relates to a blood purifier plug attached to a tubular connection port that forms a fluid inlet / outlet of a blood purifier.

  As medical devices through which liquids such as blood body fluids are circulated, blood purifiers such as hemodialyzers, leukocyte removers, blood component adsorbers, and plasma separators are known. These include one or more connection ports (also referred to as “liquid ports”) for circulation of body fluids or the like on the outer surface of a container in which a separating agent is accommodated.

  For example, in a hemodialyzer (also referred to as “artificial dialyzer”), a cylindrical container is filled with a plurality of hollow fiber membrane bundles, and the hollow fiber membrane outer peripheral surface and the cylindrical container inner periphery are formed at both ends of the cylindrical container. By adhering the surface to each other with a potting agent, the blood-side flow passage formed inside each hollow fiber membrane, and each adjacent hollow between the outer peripheral surface of the hollow fiber membrane and the inner surface of the cylindrical container A dialysate side channel formed between the thread membranes. Headers provided with blood side ports (connection ports) for circulating blood are attached to both ends of the blood side flow path. On the other hand, a dialysate side port (connection port) is usually provided in the cylindrical container at both ends of the dialysate side channel. In use, one of the blood-side ports is a blood inlet and the other is a blood outlet, and one of the dialysate ports is a dialysate inlet and the other is a dialysate outlet. The shape of each port is standardized, the blood side port has an internal thread type port shape, and the dialysis side port has a concavo-convex shape to which the dialysis coupler is easily attached and detached (see, for example, Non-Patent Document 1).

JP-A-8-280795 JP-A-6-54908

JIS-T-3250: 2005 (hemodialyzer, hemodialysis filter, blood filter and blood concentrator)

  Originally, in hemodialyzers, it is better to seal both the blood side port and the dialysis side port with stoppers for the purpose of preventing leakage of internal liquid and contact with the outside during sterilization, transportation or before and after use. . In particular, the blood-side port is highly required to prevent invasion of bacteria and foreign matters, and it is necessary to seal with a sealing plug in the production process. However, the dialysis side port may need to be opened in the production process.

  For example, in Patent Document 1, a hemodialyzer is placed in an aluminum laminate bag using a gas-permeable silicon stopper, and at the same time an oxygen scavenger is adsorbed to adsorb oxygen in the bag to make the bag an inert gas atmosphere. Is described. With this method, it takes about 21 days for the oxygen concentration to reach the target low concentration. Considering production, the intermediate product inventory becomes enormous, and there are significant disadvantages in terms of management and storage costs. In hemodialyzers currently on the market, there is a situation in which all or a part of the four ports are used with stoppers (open stoppers) that cannot be sealed because deoxidation is performed in a short time.

  In addition, ethylene oxide gas sterilization in the sterilization treatment of medical devices is a method of sterilization with the port of the medical device opened in order to express the sterilization effect by spreading ethylene oxide gas to every corner of the medical device, There are cases in which the port is opened in the open state due to factors such as the port open state processing to cope with the pressure change due to high-pressure steam sterilization, and other factors such as spark destruction due to rapid charging during electron beam sterilization.

  On the other hand, for example, in the above hemodialyzer, after removing from the aluminum laminate bag, the priming operation of the hemodialyzer (operation of washing by passing the hemodialyzer connected to the blood circuit with physiological saline) is performed. is necessary. During the priming operation, it is necessary to seal the dialysis side port in order to prevent liquid leakage from the dialysis side port. Therefore, the plug in the open state needs to be replaced with a hermetic plug, and in the state without the plug, the work of attaching the hermetic plug is necessary.

  As in the example of the hemodialyzer described above, in the blood purifier, it may be necessary to open or close the fluid inlet / outlet formed by the connection port depending on the processing. Therefore, an object of the present invention is to provide a blood purifier plug that can open and close the fluid inlet / outlet of the blood purifier with a simple operation.

  The plug for blood purifier of the present invention is a plug for blood purifier attached to a tubular connection port that forms a fluid inlet / outlet of the blood purifier, and has an opening for inserting the connection port at the lower end. A cylindrical portion that fits outside, a lid portion provided in the vicinity of the opening at the upper end of the cylindrical portion, and a connecting portion that is formed thinner than the cylindrical portion and the lid portion and connects the cylindrical portion and the lid portion; The cylinder part, the lid part, and the connection part are integrally formed, and the lid part is spaced from the connection port to open the entrance and exit, and is fitted inside the connection port to provide the entrance and exit. Between the closed position and the closed position, it is possible to move in the vertical direction with respect to the cylindrical portion while deforming the connecting portion.

  Further, when the lid part moves relative to the cylinder part, the connection part may be bent at one end that is a connection part with the cylinder part and at the other end that is a connection part with the lid part.

  In this case, the connecting portion has a thin portion formed between one end and the other end, and when the lid portion moves relative to the cylindrical portion, the connecting portion is further bent at the thin portion. Also good.

  Further, when the lid portion is in the open position, the connecting portion between the connecting portion and the lid portion is above the connecting portion between the connecting portion and the tube portion, and when the lid portion is in the closed position, the connecting portion and the lid portion are connected. The connecting portion with the portion may be located below the connecting portion between the connecting portion and the tubular portion.

  Further, when the lid portion is in the open position, the connecting portion may have a curved shape that swells toward the tube portion when viewed in a cross section including the tube axis of the tube portion.

  The connecting portion may include a plurality of thin plate portions having a predetermined width in the circumferential direction of the cylindrical portion and spaced from each other in the circumferential direction.

  Further, when the lid portion is in the open position, the top plate portion of the lid portion may be located above the opening at the upper end of the cylindrical portion.

  Further, when the lid part moves relative to the cylinder part, the connection part may be rotated by 60 ° or more around the connection part between the connection part and the cylinder part as seen in a cross section including the cylinder axis of the cylinder part. Good.

  ADVANTAGE OF THE INVENTION According to this invention, the stopper for blood purifiers which can open and close the entrance and exit of the fluid of a blood purifier by simple operation can be provided.

It is sectional drawing which shows the artificial dialyzer to which the plug for blood purifiers of this invention is applied. It is a perspective view which shows 1st Embodiment of the stopper for blood purifiers of this invention. It is the perspective view which looked at the stopper of FIG. 1 from the downward direction. It is a top view of the stopper of FIG. It is sectional drawing which shows the open state of the plug body of FIG. It is sectional drawing which shows the closed state of the plug body of FIG. It is sectional drawing which expands and shows the thin-plate part vicinity of FIG. (A)-(c) is sectional drawing which shows the deformation | transformation order of the thin-plate part of FIG. It is sectional drawing which shows 2nd Embodiment of the stopper for blood purifiers of this invention. It is sectional drawing which expands and shows the thin-plate part vicinity of the stopper of FIG.

  Hereinafter, embodiments of a plug for a blood purifier according to the present invention will be described in detail with reference to the drawings. First, an artificial dialyzer 51 will be described with reference to FIG. 1 as an example of a blood purifier using the blood purifier plug of the present invention.

As shown in FIG. 1, the artificial dialyzer 51 includes a substantially cylindrical tubular container 53 and a bundle (hollow membrane bundle) 55 of hollow fiber membranes 54 loaded along the longitudinal direction of the tubular container 53. And a potting resin portion 57 that surrounds both ends of the hollow fiber membrane bundle 55 inside both ends of the cylindrical container 53.
Both ends of the hollow fiber membrane bundle 55 are embedded and fixed in the potting resin portion 57.

  The artificial dialyzer 51 includes two blood ports 61 and 61 that form a blood inlet / outlet. The blood introduced from one blood port 61 passes through the lumen of the hollow fiber membrane 54 and is discharged from the other blood port 61. At this time, unnecessary substances in the blood pass through the hollow fiber membrane 54 and move to the dialysis side channel 59 between the hollow fiber membrane 54 and the cylindrical container 53.

  The artificial dialyzer 51 includes two tubular dialysis ports (connection ports) 63 and 63 for communicating the dialysis side channel 59 to the outside of the cylindrical container 53. In the dialysis side channel 59, a dialysis solution for transporting the unnecessary matter out of the cylindrical container 53 flows. The dialysis ports 63 and 63 form dialysis fluid inlets and outlets 63a and 63a. The dialysis ports 63 and 63 function as connection ports to which the dialysis fluid tube is connected. The dialysis ports 63 and 63 have a substantially cylindrical shape with an outer diameter of about 14.85 mm, and protrude in the radial direction from the outer surface of the cylindrical container 53.

  The blood purifier plugs 1, 201 according to the embodiment of the present invention are used by being mounted on the dialysis port 63 of the artificial dialyzer 51, for example.

(First embodiment)
The blood purifier plug 1 according to the first embodiment of the present invention will be described below with reference to FIGS. In the following description, words including the concepts of “upper” and “lower” (for example, “upper end”, “lower end”, etc.) are used based on the top and bottom of the plug 1 in the state shown in FIGS. Shall.

  As will be described in detail later, the blood purifier plug body 1 can be in two states such as an “open state” in which the inlet / outlet 63a is opened and a “closed state” in which the inlet / outlet 63a is closed while being attached to the dialysis port 63. it can. 2 to 5 show the plug 1 in an open state, and FIG. 6 shows the plug 1 in a closed state. 5 to 8 are all cross-sectional views including a cross section including a cylinder axis A (described later) of the cylindrical portion 3.

  First, the configuration of the plug 1 in an open state will be described with reference to FIGS. As shown in the figure, the plug 1 includes a cylindrical portion 3 surrounding the entire dialysis port 63, a lid portion 5 provided in a hollow portion of the cylindrical portion 3 in the vicinity of the opening 3a at the upper end of the cylindrical portion 3, and a cylindrical portion. 3, and a connecting portion 7 that connects the inner wall surface 3 and the lid portion 5. The plug 1 is attached to the dialysis port 63 so that the cylinder axis A of the cylindrical portion 3 coincides with the cylinder axis of the dialysis port 63 and the dialysis port 63 is inserted from the opening 3 b at the lower end of the cylindrical portion 3. The plug 1 is made of resin, and the cylindrical portion 3, the lid portion 5, and the connecting portion 7 are integrally formed.

  The cylindrical portion 3 has a shape that fits into the outer surface 63 s of the dialysis port 63. The entire plug body 1 is fixed to the dialysis port 63 by fitting the cylindrical portion 3 into the outer surface 63 s (FIG. 5) of the dialysis port 63. A rib 3 h (FIG. 3) is formed on the inner wall surface of the cylindrical portion 3 to form a gap with the dialysis port 63. The rib 3h has a ridge protruding inward from the inner wall surface, and the rib 3h functions as a spacer, so that a slight gap is formed between the inner wall surface of the cylindrical portion 3 and the outer surface 63s of the dialysis port 63. It is formed. Further, a stopper portion 3 j that abuts on a step portion at the tip of the dialysis port 63 is formed on the inner wall surface of the cylindrical portion 3. The stopper 1 is positioned with respect to the dialysis port 63 by the stepped portion at the tip of the dialysis port 63 abutting against the stopper portion 3j. A knurling is formed on the outer wall surface of the cylindrical portion 3.

  The lid portion 5 is concentric with the cylindrical portion 3 in plan view, and is spaced from the inner wall surface of the cylindrical portion 3 and is located in the hollow portion of the cylindrical portion 3. The top plate portion 5 a that is the upper surface of the lid portion 5 is located slightly lower than the opening 3 a that is the upper end of the cylindrical portion 3. The lower portion of the lid portion 5 has a shape that fits into the inner side surface 63t of the dialysis port 63. Although the details will be described later, the lid 5 has a function of fitting into the inner side surface 63t of the dialysis port 63 and closing the entrance / exit 63a in the closed state (see FIG. 6).

  As shown in FIG. 4, the connecting portion 7 is composed of a plurality of (six in the illustrated example) thin plate portions 9. The thin plate portion 9 has a predetermined width in the circumferential direction of the cylindrical portion 3 and is arranged at equal intervals in the circumferential direction, and bridges between the cylindrical portion 3 and the lid portion 5. That is, one end of the thin plate portion 9 is connected to the lid portion 5, and the other end of the thin plate portion 9 is connected to the inner wall surface of the cylindrical portion 3. Since the thin plate portion 9 is formed thinner than the cylindrical portion 3 and the lid portion 5, the connecting portion 7 is easily deformed by an external force as compared with the cylindrical portion 3 and the lid portion 5.

  As shown in FIG. 5, the lid 5 is located away from the dialysis port 63 when the plug 1 is in an open state. Therefore, the dialysis side flow path 59 (see FIG. 1) of the artificial dialyzer 51 communicates with the outside through the above-mentioned gap formed by the rib 3h and the gap between the thin plate portions 9 through the inlet / outlet 63a.

  Next, the transition from the open state to the closed state of the plug 1 will be described with reference to FIGS.

  As described above, the thin plate portion 9 is relatively easily deformed. Therefore, in the plug 1 in the open state shown in FIG. 5, for example, when the lid portion 5 is pressed downward with a certain amount of force, the thin plate portion 9 is bent and deformed, and the lid portion 5 is deformed with respect to the cylindrical portion 3. Translate downwards. And as shown in FIG. 6, it will be in the closed state in which the cover part 5 is located below. In this closed state, the lower portion of the lid 5 is fitted into the inner side surface 63t of the dialysis port 63, whereby the entrance / exit 63a is closed. Hereinafter, the position of the lid 5 in the opened state may be referred to as “open position P1”, and the position of the lid 5 in the closed state may be referred to as “closed position P2”. It is also possible to translate the lid 5 from the closed position P2 to the open position P1 by pulling the lid 5 upward with a certain amount of force.

  Here, as shown in FIG. 7, if the connecting portion between the thin plate portion 9 and the lid portion 5 is a lid portion connecting portion 9a, and the connecting portion between the thin plate portion 9 and the cylindrical portion 3 is a cylindrical portion connecting portion 9b, it is opened. In the transition from the state to the closed state, the thin plate portion 9 is bent at at least two locations of the lid portion connecting portion 9a and the cylindrical portion connecting portion 9b. As shown in FIG. 5, when the lid portion 5 is in the open position P1, the lid portion connecting portion 9a is located above the cylindrical portion connecting portion 9b, and as shown in FIG. 6, the lid portion 5 is in the closed position. When moved to P2, the lid connecting portion 9a moves to a position below the cylindrical portion connecting portion 9b. Further, the thin plate portion 9 rotates downward by 60 ° or more around the cylindrical portion connecting portion 9b in the cross section including the cylinder axis A (the cross sections of FIGS. 5 and 6). That is, as shown in FIG. 8C, the angle α formed by the thin plate portion 9 (two-dot chain line) in the open state and the thin plate portion 9 (solid line) in the closed state is 60 ° or more.

  In order to further facilitate the transition from the open state to the closed state as described above, a constricted portion (thin portion) 9c that is thinner than the surroundings is provided at a substantially central position of the thin plate portion 9 as shown in FIG. Is formed. In the transition from the open state to the closed state, the thin plate portion 9 is further bent temporarily at the constricted portion 9c.

  Based on the configuration of the connecting portion 7 and the thin plate portion 9 as described above, the manner of deformation of the thin plate portion 9 when shifting from the open state to the closed state is as shown in FIG. When a downward external force is applied to the lid 5 such as when the user presses the top plate 5a of the lid 5 with a finger from the opened state of FIG. 8A, the lid is shown in FIG. 8B. The connecting portion 9a and the constricted portion 9c are bent first. Thereafter, when the external force further acts, as shown in FIG. 8C, the cylindrical portion connecting portion 9b bends downward and stabilizes in that state. At this time, the lower portion of the lid 5 is fitted into the inner side surface 63t of the dialysis port 63 (see FIG. 6).

  In order to smoothly deform the thin plate portion 9 in the order as described above, the plate thicknesses of the lid connecting portion 9a, the cylindrical portion connecting portion 9b, and the constricted portion 9c may be appropriately designed. Moreover, in order to enable the deformation of the thin plate portion 9 as described above, a resin that is easily deformable to some extent may be employed as the material of the plug body 1. Examples of such a resin include polyethylene, polypropylene, and ABS resin. Moreover, in order to be able to push down the cover part 5 easily with a finger | toe, without using an instrument, the diameter of the opening 3a of the cylindrical part 3 is 8-30 mm, and the diameter of the top-plate part 5a is 7-29 mm. It is preferable.

  Then, the effect by the said plug body 1 is demonstrated.

  Generally, in the artificial dialyzer 51, when sterilization treatment with gamma rays is performed in a state where oxygen is present around the hollow fiber membrane 4, the hollow fiber membrane 4 may be deteriorated. Therefore, the artificial dialyzer 51 is enclosed in a packaging container together with an oxygen scavenger so as to remove oxygen in the dialysis side channel 59. In the packaging container, the entrance / exit 63a needs to be opened so that oxygen in the dialysis side channel 59 moves to the oxygen scavenger. When the artificial dialyzer 51 is used, a washing operation (priming operation) for washing the lumen of the hollow fiber membrane 4 with physiological saline is performed after the packaging container is opened. In the priming operation, the entrance / exit 63a needs to be closed so that the physiological saline that has permeated through the hollow fiber membrane 4 does not leak from the entrance / exit 63a. That is, in the operation of the artificial dialyzer 51, after opening the packaging container, it is necessary to close the opened entrance 63a.

  According to the plug 1, when the artificial dialyzer 51 is packaged, the open plug 1 may be attached to the dialysis ports 63 and 63, respectively, and sealed together with the oxygen scavenger in the packaging container. As a result, the entrance / exit 63a is kept open during storage, transportation, sterilization, etc. of the artificial dialyzer 51, and the dialysis side passage 59 is deoxygenated. And after opening a packaging container, the entrance-and-exit 63a can be closed by simple operation of pushing down the cover part 5 of the stopper 1 with a finger | toe. That is, before or during use of the artificial dialyzer 51, the inlet / outlet 63 can be closed by one operation to maintain the airtightness of the dialysis side channel 59.

  Here, as a plug for a conventional medical device, “a plug with only an airtight function”, “a plug with only a function to open”, “a balloon plug inflated by internal pressure”, “a plug using a gas permeable material”, “two types” There is an operation-type stopper assembled with the above-described components (see Patent Document 2, etc.). It is also conceivable to apply such a plug to a plug mounted on the dialysis port 63.

  However, with the “stopper only for airtight function”, it is not possible to deoxidize the container before the artificial dialyzer 51 is sterilized or supply EOG gas. In addition, it is not possible to avoid the destruction of the container due to a change in the internal / external pressure of the artificial dialyzer 51 during steam sterilization. With the “plug having only a function to be opened”, it is possible to prevent finger contact with the dialysis port 63, but it is not possible to prevent liquid leakage from the dialysis port 63 during the priming operation. “Balloon plugs that swell under internal pressure” are stoppers used for high-pressure steam sterilization, but they are expensive due to the high cost of raw materials that are flexible and heat resistant. When “a plug using a gas permeable material” is applied, it takes time to bring the dialysis side channel 59 to the target oxygen concentration. “Operation-type stoppers assembled with two or more types of component parts” are not designed to be sealed by medical personnel with one operation by hand, and there are three or more plug component materials, resulting in high costs. It is.

  On the other hand, according to the plug 1 described above, the above-described problems such as manufacturing and sterilization can be solved, and the manufacturing cost can be reduced.

(Second Embodiment)
Next, a blood purifier plug 201 according to a second embodiment of the present invention will be described with reference to FIGS. 9 and 10. In the plug body 201 of the present embodiment, the same or equivalent components as those of the plug body 1 described above are denoted by the same reference numerals in the drawings, and redundant description is omitted.

  As shown in FIG. 9, in the plug body 201 in the open state, the top plate portion 205 a of the lid portion 205 at the open position P <b> 1 is positioned slightly above the position of the opening 3 a of the cylindrical portion 3. Thus, since the upper end of the cover part 205 protrudes slightly from the opening 3a of the upper end of the cylindrical part 3, the operation | movement which pushes down the cover part 205 with a finger | toe becomes easy.

  Further, when viewed in a cross section including the cylinder axis A (the cross sections in FIGS. 9 and 10), the thin plate portion 209 of the plug 201 has a curved shape that swells toward the cylindrical portion 3. According to this shape, when the user pushes down the lid portion 205 with a finger, a force for bending the constricted portion 9c and the lid portion connecting portion 9a is likely to act, and the constricted portion 9c and the lid portion connecting portion 9a are smoother. Bend. Therefore, when the user presses down the cover 205 with a finger, the smooth transition from the open state to the closed state occurs.

  As mentioned above, although embodiment of this invention was described, this invention is not restricted to the said embodiment, You may change in the range which does not change the summary described in each claim. For example, the present invention is not limited to a stopper for a hemodialyzer, but can also be applied to a stopper for other blood purifiers such as a leukocyte remover, a blood component adsorber, and a plasma separator. Further, the present invention can be suitably applied particularly to a plug of a dry type blood purifier.

  In the first and second embodiments, the constricted portion 9c is provided near the center of the thin plate portions 9 and 209 when viewed in a cross section including the cylinder axis A, but the constricted portion 9c may be omitted. . That is, in the plug of the present invention, a thin plate portion (connection portion) having a uniform thickness as viewed in a cross section including the cylinder axis A may be employed. Moreover, it is also possible to employ | adopt combining suitably each component of the plug body demonstrated above.

  DESCRIPTION OF SYMBOLS 1 ... Blood purifier stopper, 3 ... Cylindrical part (cylinder part), 3a ... Upper end opening, 3b ... Lower end opening, 5 ... Lid part, 5a ... Top plate part, 7 ... Connection part, 9 ... Thin plate part, 9a ... Lid connecting part (one end), 9b ... Cylindrical part connecting part (the other end), 9c ... Constriction part (thin part), 51 ... Artificial dialyzer (blood purifier), 63 ... Dialysis port (connection port), 63a ... entrance / exit, A ... cylinder axis, P1 ... open position, P2 ... closed position.

Claims (7)

A plug for a blood purifier attached to a tubular connection port that forms a fluid inlet / outlet of the blood purifier,
A cylindrical portion that has an opening for inserting the connection port at the lower end and fits outside the connection port;
A lid provided in the vicinity of the opening at the upper end of the cylindrical portion;
A connecting portion that is formed thinner than the cylindrical portion and the lid portion and connects the cylindrical portion and the lid portion;
The tube portion, the lid portion, and the connection portion are integrally formed,
The lid is
Between the open position that opens the doorway apart from the connection port and the closed position that fits inside the connection port and closes the doorway, while deforming the connection portion, movable der in the up-and-down direction Te is,
The connecting portion is
A plug for a blood purifier having a plurality of thin plate portions having a predetermined width in the circumferential direction of the cylindrical portion and spaced apart from each other in the circumferential direction . When the lid part moves relative to the cylinder part,
The connecting portion is
The plug for a blood purifier according to claim 1, wherein the plug is bent at one end that is a connecting portion with the cylinder portion and at the other end that is a connecting portion with the lid portion. The connecting portion has a thin portion formed between the one end and the other end,
When the lid part moves relative to the cylinder part,
The connecting portion is
The blood purifier plug according to claim 2, further bent at the thin portion. When the lid is in the open position,
The connecting portion between the connecting portion and the lid portion is above the connecting portion between the connecting portion and the cylindrical portion,
When the lid is in the closed position,
The connection part of the said connection part and the said cover part exists in the downward direction rather than the connection part of the said connection part and the said cylinder part, The blood purifier for any one of Claims 1-3 characterized by the above-mentioned. Plug body. When the lid is in the open position,
The connecting portion is
The plug for blood purifier according to any one of claims 1 to 4, wherein the plug for blood purifier according to any one of claims 1 to 4, which has a curved shape that swells toward the cylinder part when viewed in a cross section including the cylinder axis of the cylinder part. When the lid is in the open position,
The plug for a blood purifier according to any one of claims 1 to 5 , wherein the top plate portion of the lid portion is positioned above the opening at the upper end of the cylindrical portion. When the lid part moves relative to the cylinder part,
The connecting portion is
Viewed in cross section including the cylinder axis of the cylindrical portion, according to any one of claim 1 to 6, wherein the rotating least 60 ° around the connection portion between the cylindrical portion and the connecting portion Blood purifier plug.

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