JP4069939B2 - Fluid port plug and medical device comprising the same - Google Patents

Description

  The present invention relates to a plug for a fluid port and a medical device including the plug.

  Containers filled with fluids such as gas, water, and aqueous solutions, such as medical devices, such as leukocyte removers, blood component adsorbents, plasma separators, and artificial kidneys, are used for circulation of body fluids and water and aqueous solutions. One or more fluid ports for liquid are provided. Each fluid port is covered with a plug for the purpose of preventing leakage of internal fluid during sterilization or transportation. The material constituting the plug body is mostly a rubber elastic body such as silicon because a soft material can be brought into close contact with the fluid port. FIG. 5 and FIG. 6 are examples thereof, and the plug is made of a soft material (see Patent Documents 1 and 2, respectively).

  However, in this case, there is a problem that the cost is increased. One method for solving this problem is to form the plug body with a relatively hard resin. FIG. 7 shows an example, and convex shapes 35a and 35b are formed on a cylindrical wall 32 as a fluid port 31 (see Patent Document 3). On the other hand, in the plug body 40 that covers the cylindrical wall 32 in a sealed state, a cylindrical sealing body is integrally formed on the back surface of the top plate 41, and the convex shapes 35a and 35b are formed on the inner peripheral surface of the cylindrical body 42. Intrusion portion 46 and concave grooves 44a and 44b into which convex shapes 35a and 35b that have entered the intrusion portion 46 when the plug body 40 is rotated for sealing can be formed. The plug body is covered with the fluid port from above, and the plug body is rotated in a state where the plug body is pressed slightly downward, thereby forming a sealed state between them. However, the sealed state is maintained as it is.

However, in this case, when the stopper is pushed and twisted at the time of plugging, the convex portion formed on the outer peripheral surface of the fluid port enters the concave portion of the intrusion portion formed on the inner peripheral surface of the stopper, and the sealed state is maintained. It is to secure. Therefore, when a large amount of plugging is performed on the production line, it is necessary to provide not only a mechanism for pushing the plug body but also a mechanism for rotating the plug body, and the cost increase in production cannot be denied. Further, the fluid port has a problem that a convex portion for entering a concave portion of an intrusion portion formed on the inner peripheral surface of the stopper must be formed.
Utility Model Registration No. 3020188 JP-A-7-275356 JP 2002-172161 A

  The present invention solves the above-described problems in the prior art, and can be made of an inexpensive and relatively hard resin, and can only be pushed in without turning the plug body when plugging and unplugging. The fluid port and stopper can be sealed, and when the internal pressure of the container rises during sterilization or transportation, the fluid port can prevent the internal liquid from leaking due to the stopper being removed. It is an object of the present invention to provide a plug body and a medical device using the same.

In order to achieve the above object, the plug according to the present invention is made of a polyolefin resin having a flexural modulus of 110 MPa or more and 1000 MPa or less, and has a head and a thickness of 0.05 mm or more and 0.1 mm or less. A cylindrical portion having three or more stages of ultra-thin fins on the outer periphery, and when inserted into the fluid port, the multi-stage ultra-thin fins are pressed against the inside of the fluid port to form a sealed state therebetween. Even if the internal pressure varies after sealing, the sealed state is maintained as it is. That is, when inserted into the fluid port, the ultrathin fin is elastically deformed along the inner periphery of the fluid port, and the fluid port is sealed using a force to return to the original shape.

  Plugging and unplugging is easy by pushing and pulling out the plug body. Hands do not come into direct contact with the fluid port when plugging and unplugging. It is possible to prevent the internal fluid from leaking out due to plug removal or the like when it is received or when the internal pressure of the container rises due to sterilization or a change in the temperature of the outside air.

In addition, the plug body can be made of a relatively hard material having a flexural modulus of 110 to 1000 MPa, so the plug body can be made of polyolefin resin, and a significant cost reduction can be expected. Possible fluid port plugs can be provided.

The plug body of the fluid port according to the present invention includes a head portion and a cylindrical portion having multi-stage ultrathin fins on the outer periphery. Since the bending elastic modulus of the plug body tends to make it difficult to obtain elastic deformation of the ultra-thin fin when it exceeds 1500 MPa, it is preferably 1500 MPa or less. More preferably, it is 110 MPa or more and 1000 MPa or less. The plug according to the present invention can be easily molded using an injection molding machine. For this purpose, preferred examples of the material include polyolefin resins. Among them, polypropylene, polyethylene and the like are preferably used because of their sealing performance, ease of molding, and low cost.

  The size of the head diameter is arbitrary as long as it is larger than the outer diameter of the fluid port. However, in order to obtain better operability, or the hand touches the fluid port during tapping and unplugging. In order to avoid doing so as much as possible, it is more preferable that it be larger than the outer diameter of the fluid port by 10 mm or more.

    The height of the head is not particularly limited, but 5 mm or more is preferable in order to obtain better operability. In order to obtain even better operability, it is preferable that the outer peripheral surface in the height direction of the head has a plurality of small grooves. As long as the operability is not impaired, the outer peripheral surface in the height direction of the head may have a hollow portion. The outer diameter of the cylindrical portion is arbitrary on condition that it is smaller than the inner diameter of the fluid port, and the length of the cylindrical portion is also optional on the condition that multistage ultrathin fins can be provided.

The ultra-thin fin is elastically deformed along the inside of the fluid port when inserted into the fluid port, and seals the fluid port using the force to return to the original shape. It is necessary to be. Here, the thickness of the ultra-thin fin refers to the length in the central axis direction of the cylindrical portion of the plug, and the length of the ultra-thin fin refers to the circumference of the ultra-thin fin in the outer circumferential direction from the central axis of the cylindrical portion of the plug. It refers to the length from the end to the surface of the cylindrical portion. More specifically, A in FIG. 4 is the thickness of the ultrathin fin, and B is the length of the ultrathin fin. When the thickness of the ultra-thin fin exceeds 0.2 mm, elastic deformation becomes difficult, so that the sealing function is remarkably deteriorated by repeated use, and the operation becomes difficult. Moreover, since it becomes difficult to manufacture when it is less than 0.05 mm, it is not preferable. Therefore, it is preferable that it is 0.05 mm or more and 0.2 mm or less.
The outer diameter of the ultrathin fin provided in the plug according to the present invention (or the outer diameter of the cylindrical portion including the ultrathin fin portion) is appropriately set according to the inner diameter of the fluid port. From the viewpoint of operability, 1.06 times or more and 1.2 times or less the inner diameter of the fluid port is preferable. That is, it is preferable to satisfy the following formula when expressed by the formula.

d1 = a × D (1.06 ≦ a ≦ 1.2)
d1 indicates the outer diameter of the ultrathin fin, and D indicates the inner diameter of the fluid port.

  In addition, the inner diameter of the ultra-thin fin (or the outer diameter of the cylindrical portion not including the ultra-thin fin portion) is set as appropriate according to the inner diameter of the fluid port and the required sealing function, as with the outer diameter of the ultra-thin fin Is done. From the viewpoint of operability, it is preferably 0.45 times or more and 0.96 times or less of the inner diameter of the fluid port. That is, it is preferable to satisfy the following formula when expressed by the formula.

d0 = b × D (0.45 ≦ b ≦ 0.96)
d0 represents the inner diameter of the ultrathin fin, and D represents the inner diameter of the fluid port.

  When the plug body is required to have a function of sealing the fluid port for a long period of time, it is particularly preferable to select a small numerical value within the above range b in order to minimize plastic deformation and creep of the fin. preferable. In addition, a higher sealing function effect can be obtained when a short-term sealing function is required, for example, when creep characteristics in long-term storage such as temporary sealing in the production process are not a problem. Therefore, it is particularly preferable to select a large numerical value within the range of b.

  The number of ultrathin fins is preferably 5 or more in order to sufficiently obtain a desired sealing function. In addition, by setting the number of ultra-thin fins to 5 or more, the plug body itself can be stably fixed to the fluid port, and the plug body can be prevented from being unintentionally unplugged. Even if an unexpected and unexpected impact occurs on the body, the risk of looseness can be reduced.

  Furthermore, it is preferable that the cylindrical portion having multi-stage ultra-thin fins on the outer periphery is hollow inside as illustrated in FIGS. By hollowing out the inside, a force that presses the multi-stage fins against the inner periphery of the fluid port due to an increase in pressure in the fluid port acts, so that a higher sealing function effect can be obtained. Further, further cost reduction can be achieved by reducing the amount of resin used for manufacturing the plug body.

  The plug body can be inserted by simply pressing the top surface of the head of the plug body, the insertion operation is easy, and it is possible to avoid the hand or the like from coming into direct contact with the fluid port. When unplugging, the unplugging operation is completed simply by grasping the side of the head and pulling up the plug body in the axial direction of the fluid port. The operation is easy and direct contact with the fluid port can be avoided.

  If it is desired to completely avoid contact with the outer periphery of the fluid port depending on the use situation, a cover can be attached to the stopper. This can more thoroughly avoid direct contact with the fluid port. Therefore, the plug according to the present invention can be effectively used as a plug of a fluid port of a medical device that is desired to avoid contact with the outer periphery of the fluid port.

  The fluid port to which the plug of the present invention is applied includes a leukocyte remover, a blood component adsorbent, a plasma separator, an artificial kidney, an artificial liver, an artificial lung, a plasma separator, an ultrafilter, a water purifier and the like. Means the entrance / exit part, and the inside of the device having such a fluid port contains water such as distilled water for injection, ion exchange water, ultrafiltration water, physiological saline, buffer solution, infusion, dialysate, etc. The fluid exemplified in the aqueous solution is filled. Among these, artificial kidneys, artificial livers, artificial lungs and the like are sterilized, and sterilization methods such as high-pressure steam sterilization, heat sterilization, radiation sterilization, and electron beam sterilization are used. All of these involve heating, and the internal pressure in the medical device rises due to the expansion of the content liquid, so high pressure-tightness is required. Therefore, the plug according to the present invention is particularly used as a plug for a fluid port of a medical device. Can be used effectively.

  Moreover, the plug body of the fluid port in the present invention can be suitably used for, for example, a fluid port of ISO8637: 2004 (E) and EN1283: 1996 standards. Therefore, it is most preferable to provide the fluid port plug of the present invention for an artificial kidney having a fluid port of this standard in a medical device.

  Hereinafter, preferred embodiments of a plug for a fluid port according to the present invention will be described with reference to the drawings, but the plug of the present invention is not limited thereto.

  FIG. 1 is an enlarged view showing a plug body and a fluid port, and shows a state before the plug body is inserted. FIG. 2a is a side view of the state before the plugging of FIG. FIG. 2b shows a partially cross-sectional view after the stoppering.

  A plug 1 of a fluid port shown in FIG. 1 is a plug having a head 2 and a cylindrical portion 3 having a diameter smaller than that of the head, and this cylindrical portion is concentric with the cylindrical portion along its outer periphery. The multi-stage ultra-thin fins 4 are provided, and a hollow portion 5 is provided inside the cylindrical portion.

  FIG. 2a is a cross-sectional view of the plug body before the fluid port is inserted. When the plug is inserted into the fluid port 6 from this state, the ultra-thin fins provided in the plug as shown in FIG. 2b are elastically deformed along the inner periphery of the fluid port. Since the ultra-thin fin is pressed against the inner periphery of the fluid port by the force to return to the original shape, the sealing of the fluid port is completed. FIG. 2c is an enlarged view of the ultrathin fin after deformation.

  When it is desired to completely avoid contact with the outer periphery of the fluid port when plugging and unplugging the plug of the present invention, a cover 7 can be attached to the plug as shown in FIG. As a result, it is possible to completely avoid contact of a human hand or the like with the fluid port.

Examples 1-4 and Comparative Examples 1-3
With the shape and dimensions of the plug and fluid port shown in FIG. 4, using polyethylene (PE) or polypropylene (PP, Comparative Example 1 ) with flexural modulus of 110, 165, 195, 660, 1200, 1300 MPa, respectively, A plug body having seven steps of fins with a thickness of 0.1 mm on the outer periphery of the cylindrical portion was prepared. After plugging into a fluid port of a PP hollow fiber membrane module type artificial kidney, the internal pressure of the artificial kidney was increased, and the plug body was removed. Operability at the time of plugging, plugging and unplugging (Examples 1-4, Comparative Examples 1-2 ).

  In the evaluation of plug removal (deplugging), the required sealing function varies depending on the production process, sterilization method, etc., but it is sufficient if the sealing is maintained for the internal pressure increase value of about 0.1 MPa. is there.

Further, a plug body having seven stages of fins having a thickness of 0.2 mm on the outer periphery of the cylindrical portion using polypropylene having a bending elastic modulus of 1000 MPa with the shape and dimensions of the plug body and the fluid port shown in FIG. 4 and Table 1 was prepared. The same confirmation as above was performed ( Comparative Example 3 ).

  Repeated operability at the time of plugging and unplugging is ◎ (very good with no hindrance to plugging and unplugging work), ○ (generally good without any major problems), △ (depending on the worker) The evaluation was made in four stages, i.e., it feels difficult to perform plugging and unplugging, and x (working efficiency is very difficult because of the difficulty of plugging and unplugging). The results are shown in Table 1.

  As is apparent from the test results in Table 1, a plug body having a bending elastic modulus of 110, 165, 195, 660 MPa and a fin thickness of 0.1 mm can be sufficiently sealed and removed. There was no stopper and the operability was safe without any major problems.

Further, the plugs of Comparative Examples 1 and 2 having a flexural modulus of 1200, 1300 MPa and a fin thickness of 0.1 mm, and the plug of Comparative Example 3 having a flexural modulus of 1000 MPa and a fin thickness of 0.2 mm are slightly different. Although it showed difficulty in operability, it was confirmed that it had no sealing and had a sufficient sealing function.

The plugs of the fluid ports in Examples 1 to 4 and Comparative Examples 1 and 2 are made of a polyolefin resin having a bending elastic modulus of 100 to 1500 MPa. This expresses elastic deformation of the ultra-thin fin provided in the cylindrical portion of the plug. That is, when viewed as a whole, there is no problem if the ultrathin fin is within a bending elastic modulus of 100 to 1500 MPa that can be deformed along the inner periphery of the fluid port.
Examples 5 and 6
The same evaluation as in Example 2 was performed except that the number of ultrathin fins included in the plug body was 5 and 3, respectively. The results are shown in Table 2.

  As can be seen from the test results in Table 2, the plug body with three stages of ultra-thin fins had good operability when plugging and unplugging, but the fixing state of the plug body was unstable and the fins were unstable. The sealing function was slightly inferior. The sealing function of the plug body of five or more stages was good, and the operability and the fixed state of the plug body were stable. From this, it was confirmed that the ultra-thin fins are particularly preferably five or more stages.

  According to the present invention, the plugging and unplugging is easy only by pushing in and pulling out the plug body, there is no direct contact with the fluid port at the time of plugging and unplugging, and vibration during transportation It is possible to prevent internal fluid from leaking out due to plug removal, etc. when subjected to impacts due to or when the internal pressure of the container rises during sterilization or due to temperature changes of the outside air, etc. Can be made of a relatively hard material having a bending elastic modulus of 100 to 1500 MPa, so that the plug body can be made of a polyolefin resin, and a drastic cost reduction can be expected. Is obtained.

The perspective view which shows one Embodiment of the plug of the fluid port by this invention. It is the figure which looked at the state before the stoppering of FIG. 1 from the side. The state after the plugging of FIG. 1 is partially shown in cross section. It is an enlarged view of the ultra-thin fin after a deformation | transformation. The figure which shows an example in the case of attaching a cover to a stopper with a partial cross section figure. The figure which shows the dimension of the plug used for Examples 1-6 and Comparative Examples 1 and 2. FIG. The figure explaining an example of the plug of the conventional fluid port.

(Quoted from Utility Model Registration No. 3020188)
The figure explaining an example of the plug of the conventional fluid port.

(Quoted from JP 7-275356 A)
The figure explaining an example of the plug of the conventional fluid port.

          (Quoted from JP 2002-172161 A)

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Plug body 2 Head part 3 Cylindrical part 4 Ultra-thin fin 5 Cavity part 6 Fluid port 7 Cover 10 Plug body 11 by conventional rubber elastic body Flat head part 12 Cylindrical part 13 Tip part 14 Convex rib 20 Conventional rubber elasticity Plug body 21 holding part (corresponds to the head)
22 Mounting part (corresponds to cylindrical part)
23 Rib 30 Medical device 31 Fluid port 32 Cylindrical wall 33 Small diameter portion 34 Annular depression 35a Convex portion 35b Convex portion 36 Inner peripheral surface 40 of cylindrical wall Plug body 41 Top plate 42 Cylindrical body 43 Bottom edge 44a of plug body Concave groove 44b Concave groove 45 End part 46 of concave groove Thin part (intrusion part)
47 Upper wall of thin part

Claims (4)

A plug body provided in a fluid port, the plug body is made of a polyolefin resin having a flexural modulus of 110 MPa or more and 1000 MPa or less, and includes a head portion and a cylindrical portion. The part has three or more ultra-thin fins on the outer periphery, and the thickness of the ultra-thin fins is 0.05 mm or more and 0.1 mm or less. The plug of the fluid port for an artificial kidney according to claim 1, wherein the relationship between the inner diameter of the ultrathin fin, the outer diameter of the ultrathin fin, and the fluid port inner diameter is expressed by the following equation.
d0: inner diameter of the ultrathin fin d1: outer diameter of the ultrathin fin D: inner diameter of the fluid port d1 = a × D (1.06 ≦ a ≦ 1.2)
d0 = b × D (0.45 ≦ b ≦ 0.96) 3. The plug member for an artificial kidney of a fluid port according to claim 1, wherein the number of stages of the ultra-thin fins is 5 or more. An artificial kidney comprising the plug of the fluid port of the artificial kidney according to any one of claims 1 to 3.

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