MX2011013361A - Medical device for forming liquid communication path. - Google Patents

Abstract

A medical device for forming a liquid communication path, comprising: joining members (1, 3) for forming the communication flow path between objects to be communicated with each other; and a protective cap (2) having a tubular shape with a closed end, holding a germicide-impregnated member (18) at the deepest end of the protective cap, and capable of being mounted to at least one of the joining members which are being separated from each other. The inner peripheral surface of the protective cap forms a space (19) for surrounding the tip of the joining member, and the dimensional relationship between the joining member and the protective cap is set so that the germicide-impregnated member (18) faces the tip of the joining member with a spacing between the members. A sealing member (8) is mounted to the inner peripheral surface of the opening end of the protective cap or to the outer peripheral surface of that portion of the joining member which corresponds to the opening end of the protective cap, and when the protective cap is in a mounted state, the sealing member is pressed between the outer peripheral surface of the joining member and the inner peripheral surface of the protective cap to form an airtight structure for the space. The mounting of the cap on the joining member effectively sterilizes the tip of the joining member and, in addition, avoids leakage of the germicide due to the contact of the joining member with the germicide-impregnated member.

Description

MEDICAL DEVICE TO FORM TRAJECTORY OF LIQUID COMMUNICATION Technical Field The present invention relates to a medical device for forming a communication path for liquids that forms a flow communication path between objects to be communicated by connection junction members attached to the respective objects to be communicated, for example, a device connector for connecting medical tubes. In particular, the present invention relates to a medical device for forming a liquid communication path that includes a protective cap that has a sterilization function and that can be attached to at least one of the connection members when they are separated.

Background Technique As an example of the medical device for forming a liquid communication path, a medical connector is known and used, for example, for the exchange of a dialysis solution in peritoneal dialysis. The medical connector connects a transfer tube (extension tube) of a patient to a bag containing the dialysis solution. Peritoneal dialysis (PD) is a medical treatment in which the dialysis solution is stored in the abdominal cavity of a patient through a peritoneal catheter that has been surgically implanted in the patient's abdominal cavity and impurities accumulated in the patient's body. patient are separated by filtration using the capillaries of the peritoneum. The patient goes to their daily activities with the transfer tube (your extension cord in continuous use that is connected to the peritoneal dialysis catheter outside the body.) Then the patient himself connects the dialysis solution bag to the end of the transfer tube. several times a day to exchange the dialysis solution in the abdominal cavity.

The most serious problem with peritoneal dialysis is to let the bacteria, which are present in the air or attached to the skin, inadvertently enter the abdominal cavity with the dialysis solution during the exchange of the dialysis solution several times a day. day . If the bacteria enter the abdominal cavity, they cause an inflammation of the peritoneum, and there is a danger that the patient will develop peritonitis.

Thus, in peritoneal dialysis, it is important to remove the bacterial contamination of the connector that is attached to the end of the transfer tube for connection to the dialysis solution bag. A povidone iodine solution is generally used to sterilize tools, tissues, etc. In such a case, as a general method, the povidone iodine solution is applied to the objects to be sterilized and exerts its effect. Therefore, in the case of the above medical connector, the connector attached to the end of the transfer tube is covered with a cap containing a porous material (e.g., a sponge) that is impregnated with a germicide such as povidone iodine. (which is referred to as a member impregnated in the following), and thus the end portion of the connector is sterilized (see Patent Documents 1 to 3).

A medical connector device described in Patent Document 2 will be described with reference to the cross-sectional views in Figures 13 and 14. Figure 13 (a) shows a side bag connector 110 which is a female connector provided in a dialysis solution bag. Figure 14 (b) shows a patient side connector 130 which is a male connector. Figure 13 (b) shows a lid 120 of the bag side connector. Figure 14 (a) shows a patient side connector cap 140.

The side bag connector 110 has a double wall formed in a first annular luer portion 111 and a first cylindrical front portion 112. A base portion 115 of the first annular luer portion 111 is provided with a first tube connection portion 116. The first tube connection portion 116 is connected to a tube 119 which is connected to the dialysis solution bag. A depression 117 is formed in the outer surface of the base portion 115, and a protrusion 118 is formed at the base of the first cylindrical front portion 112. The first cylindrical front portion 112 is accommodated in (i.e., attached to) the base portion 115 via the depression 117 and the protrusion 118 to be rotated independently of the first tube connection portion 116 or the first annular portion 111 of the luer. . An internal thread 113 is cut on the inner surface of the first cylindrical front portion 112. In addition, a sealing member 114 made of an elastic material is embedded in the inner surface of the first annular luer portion 111 in the vicinity of its front end.

On the other hand, the patient side connector 130 includes a cylindrical front portion 132, a second annular luer portion 131 that is positioned within the cylindrical front portion 132, and a base portion 134 provided with a second tube connection portion 135. . The second tube connection portion 135 is connected to a tube 136. The base of the cylindrical front portion 132 is attached to the base portion 134. The cylindrical front portion 132 extends beyond the front end of the second annular luer portion 131 to cover it. An external thread 133 is made on the outer surface of the cylindrical front portion 132 and is to be screinto the internal thread 113 made on the inner surface of the first cylindrical front portion 112 of the side bag connector 110. In addition, the outer surface of the second annular luer portion 131 can make fluid-tight contact with the sealing member 114 provided on the inner surface of the first annular luer portion 111 in the vicinity of its front end.

The side bag connector 110 and the patient side connector 130 are brought together, and then only the first cylindrical front portion 112 is rotated independently so that the external thread 133 is screinto the internal thread 113 without screwing the tubes 119, 136. Consequently, both connectors can be connected.

The patient side connector cap 140 includes a third internal cylinder 141, a third external cylinder 142 formed concentrically around the third internal cylinder 141 and a plug 146 accommodated at the front end of the third internal cylinder 141. An internal thread 143 is made on the inner surface of the third external cylinder 142, where the external thread 133 made on the external surface of the front indian portion 32 of the lateral connector 1 of the patient is to be scre A sealing member 145 made of an elastic material is placed on the inner edge of the front end of the third external cylinder 142, where the internal thread 143. ends. A sterilization pad 144 containing a germicide is attached to the base of the third cylinder internal 141 The plug 146 is made of a resilient material and urged toward the second annular luer portion 31 to provide fluid-tight sealing. The sterilization pad 144 serves to sterilize the cylindrical front portion 1 32 when the patient side connector 1 30 is screinto the patient side connector cap 140. The sealing member 1 45 seals the inside of the lid 1 40 of the patient side connector connected to the patient side connector 1130, and protects it from external contamination.

The side connector cap 120 of the bag includes a fourth cylindrical front portion 1 21 and a fourth base portion 1 23 of the cap. An external thread 1 22 is made in the fourth cylindrical front portion 1 21 and is to be screinto the internal thread 1 1 3 made on the inner surface of the first cylindrical front portion 1 1 2.

With the connector device that has the previous configuration, when the infusion of the dialysis solution is finished and then disconnect the patient side connector 130 and the side bag connector 1 1 0, a new patient side connector cap 140 is attached to the patient side connector 1 30 and the patient side connector 1 30 is screinto this cap 1 40 of patient side connector. Thus, the cylindrical front portion 132 of the patient side connector 1 30 is pressed against the sterilization pad 144 in the patient side connector cap 140 and the sterilization state can be maintained.

Documents of the Prior Art Patent Documents Patent Document 1: J P S59 (1 984) -500801 A Patent Document 2: J P H8 (1996) -1 55025 A Patent Document 3: J P H8 (1 996) -21 531 1 A Description of the invention Problem to be solved by the I nvention In conventional medical practice, the sterilization of an object to be sterilized is generally carried out by bringing the object to be sterilized into direct contact with a germicide. Therefore, both structures of Patent Documents 1, 2 are designed to assure that the front end portion of the connector makes contact with the impregnated member in the cap. In these structures, the front end portion of the connector is pressed against the impregnated member so that the germicide seeps out of the impregnated member.

However, the above structures may have problems that the germicide that has leaked out of the impregnated member enters the internal flow path of the connector / conduit from the front end portion of the connector or leaks outward from the joint between the connector and the cap and may cause contamination of the surrounding area.

As a result, there is a possibility that the germicide enters the patient's body through the internal flow path of the transfer tube and has a detrimental effect on the health of the PD patient.

In the method described in Patent Document 3, the impregnated member (absorbent material 1 0) has to be pressed when the protective cap and the closure member are to be removed from the pipe. Therefore, the germicide leaks out of the impregnated member due to pressure and can leak from a joint between the protective cap and the closure member, leading to contamination of the surrounding area.

Such a problem is not limited to the connector that is connected to a peritoneal dialysis tube, but common to the connector used at a position where a liquid flow path (eg, an infusion tube) needs to be connected. More generally, the above problem is common for the medical device to form a liquid communication path that forms a flow communication path between objects to be communicated using connection members attached to the respective objects that they will communicate. More specifically, the above problem is common for The configuration includes a protective cap that has a sterilization function and can be attached to one of the connecting members in a separate condition.

Therefore, with the foregoing in mind, it is an object of the present invention to provide a medical device for forming a liquid communication path that allows the front end portion of a connecting member to be sufficiently sterilized by joining a protective cap which maintains a member impregnated with germicide at the bottom of the connecting member and which can prevent leakage of the germicide caused by contact between the front end portion of the connecting member and the germicidal impregnated member.

Means to Solve the Problem A medical device for forming a fluid communication path of the present invention includes the following: connection members that are connected to objects that are to be communicated, respectively, and form a flow communication path between the objects that they will communicate when they are together; and a protective cap having a cylindrical shape with a closed end, contains a member impregnated with germicide in a bottom and can be attached to at least one of the connection members when the connection members are separated.

To solve the above problems, in the medical device a dimensional relationship is determined between the at least one of the connecting members and the protective cap is determined so that when the protective cap is attached to the connecting member, a circumferential surface internal protection cap It forms a space that surrounds the front end portion of the connecting member and the germicidal impregnated member faces the front end portion of the connecting member with a distance therebetween. A side member is provided on an inner circumferential surface of an opening end of the protective cap or an outer circumferential surface of the connecting member at a location corresponding to the opening end of the protective cap. When the protective cap is attached to the connecting member, the sealing member is pressed between the outer circumferential surface of the connecting member and the inner circumferential surface of the protective cap, thus providing an air-tight structure of the space.

Effects of the Invention The above configuration can achieve a sufficient sterilizing effect by attaching the protective cap which keeps the member impregnated with germicide on the bottom, even if the germicide impregnated member is not in contact with the front end portion of the connecting member. . In addition, the above configuration can prevent leakage of the germicide caused by contact between the end face portion of the connecting member and the germicide impregnated member.

Brief description of the Di bu jos [FIG. 1A] Figure 1A is a perspective view showing a male connector and a protective cap in a separate state, composing a medical connector device according to Modality 1 of the present invention.

[FIG. 1B] Figure 1B is a perspective view showing the protective cap attached to the male connector in the medical connector device of Figure 1A.

[FIG. 2A] Figure 2A is a perspective view showing a female connector that makes up the medical connector device of Figure 1A.

[FIG. 2B] Figure 2B is a perspective view showing a state in which the male connector of Figure 1A and the female connector in Figure 2A are connected.

[FIG. 3A] Figure 3A is a front view of the male connector of Figure 1A.

[FIG. 3B] Figure 3B is a right side view of the male connector of Figure 3A.

[FIG. 3C] Figure 3C is a cross-sectional view of the male connector of Figure 3A.

[FIG. 4A] Figure 4A is a front view of the protective cap of Figure 1A.

[FIG. 4B] Figure 4B is a right side view of the protective cap of Figure 4A.

[FIG. 4C] Figure 4C is a cross-sectional view taken along line A-A of Figure 4A.

[FIG. 4D] Figure 4D is a cross-sectional view taken along line B-B of Figure 4B.

[FIG. 5A] Figure 5A is a cross-sectional view showing the male connector and the protective cap of Figure 1A.

[FIG. 5B] Figure 5B is a front view showing the male connector and the protective cap of Figure 1B.

[FIG. 5C] Figure 5C is a cross-sectional view showing internal structures of the male connector and the protective cap of Figure 5B.

[FIG. 6A] Figure 6A is a front view of the female connector of Figure 2A.

[FIG. 6B] Figure 6B is a left side view of the female connector of Figure 6A.

[FIG. 6C] Figure 6C is a right side view of the female connector of Figure 6A.

[FIG. 6D] Figure 6D is a cross-sectional view of the female connector of Figure 6A.

[FIG. 7A] Figure 7A is a cross-sectional view showing the male connector and the female connector that are separated.

[FIG. 7B] Figure 7B is a front view showing the male connector and the female connector that are connected.

[FIG. 7C] Figure 7C is a cross-sectional view of the male connector and the female connector in Figure 7B.

[FIG. 8] Figure 8 is a graph showing the experimental results demonstrating the effect of preventing filtration of a povidone iodine solution by the medical connector device according to Modality 1 of the present invention.

[FIG. 9A] Figure 9A is a graph showing the experimental accelerated storage results demonstrating the retention ability of the sterilization capability of the medical connector device of Modality 1.

[FIG. 9B] Figure 9B is a graph showing the experimental results of storage at room temperature demonstrating the retention ability of the sterilization capability of the medical connector device of Modality 1.

[FIG. 10A] Figure 10A is a front view showing a connector and a protective cap constituting a connector device for enteral feeding according to Modality 2 of the present invention.

[FIG. 10B] Figure 10B is a cross-sectional view showing an internal structure of the protective cap in Figure 10A.

[FIG. 10C] Figure 10C is a front view showing a state in which the protective cap is attached to the connector, where only the protective cap is illustrated in a cross-sectional view.

[FIG. 11A] Figure 11A is a perspective view showing a mixed injection orifice and a protective cap constituting a mixed injection orifice device according to Mode 3 of the present invention.

[FIG. 11 B] Figure 11 B is a cross-sectional view showing an internal structure of the protective cap of Figure 11 A. [FIG. 12] Figure 12 is a perspective view showing another aspect of the mixed injection orifice of Figure 1 1 A.

[FIG. 1 3] Fig. 1 3 is a cross-sectional view showing a configuration of a conventional medical connector device.

[FIG. 14] Fig. 14 is a cross-sectional view showing a configuration of a conventional medical connector device.

Description of the invention The medical device for forming a liquid communication path of the present invention may have the following aspects based on the above configuration.

U of the connecting members can be a male connector and a connecting portion that is connected to one of the objects to be communicated can be provided in a rear end portion of the male connector. The other connection members may be a female connector, and a portion of an ion that is connected to the other of the objects to be communicated may be provided at a rear end portion of the female connector.

The male connector may include an internal cylinder that has an internal cavity that serves as a liquid flow path and an outer cylinder that has an inner diameter larger than an outer diameter of the inner cylinder and is coaxially connected to the outer side of the cylinder. internal cylinder. A front end of the internal cylinder can be placed inside a front end of the outer cylinder. The protective cap and female connector can be attached to an exterior of the external cylinder.

It is preferable that the male connector has a shut-off valve in a portion of the front end to close an internal cavity, that the female connector includes an internal cylinder having an internal cavity that serves as a liquid flow path and a cylinder. which has an internal diameter larger than an external diameter of the internal cylinder and coaxially to an outside of the internal cylinder, so that the male connector can be inserted into the external cylinder so that the male connector and the Female connectors are connected and that when the male connector and the female connector are connected, a front end of the internal cylinder of the female connector penetrates the shut-off valve and thus opens a flow path.

In this case, it is preferable that an eyebrow be provided on an inner surface of the male connector in a location nearer to the front end of the male connector than the shut-off valve, which defines an aperture which is smaller than an external diameter. of the closing valve.

In addition, the eyebrow preferably has a rib extending to the front end of the male connector.

A position limiting portion can be provided within the protective cap and limit a position of the male connector moving towards the bottom in the protective cap to secure the space.

The limiting position portion can be formed from an annular eyebrow and a contact portion having an outer diameter more It is great that an inner diameter of the annular eyebrow may be formed on an outer surface of the front end portion of the male connector. When the male connector and the protective cap are connected, the position of the male connector moving towards the bottom in the protective cap can be limited by the contact between the annular eyebrow and the contact portion.

The male conne and the protective cap can be joined by a screw connection and the deeper position of the screw connection between the male conne and the protective cap can function as the limiting position portion and limits the position of the male conne that is moves to the bottom in the protective cap.

An internal member can be accommodated in the protective cap and allow the member impregnated with germicide to remain at the bottom of the protective cap.

The inner member may have a position limiting portion that limits a position of the male conne moving towards the bottom in the protective cap to secure the space.

The protective cap can be provided on the bottom with a small diameter portion having a smaller diameter than a aperture of the protective cap and the germicide impregnated member can be placed on the reduced diameter portion.

One of the objects to be communicated may be a hole: from a medical container to inject a nutritional supplement or the similar ones used for enteral feeding and the other may be an enteral feeding set that includes a tube to connect the medical container and a patient. In this case, a conne for enteral feeding that is provided in the hole of the medical container may constitute one of the connecting members and a conne that is provided at one end of the enteral feeding set and is to be connected to the conne for feeding enteral may constitute the other of the connecting members.

One of the connection members may be a mixed injection orifice. The mixed injection orifice may include a seat that is provided in one of the objects to be communicated, a disk valve that is supported by the seat from the bottom side and has an insertion hole in the center and a cover that has an accommodation hole for exposing an upper surface of a central portion of the valve and covering a valve hoop on the upper side. The other of the connecting members may be an insert member which can be inserted into the mixed injection port and has an internal cavity which serves as a flow path. In this case, the protective cap can be configured to join the mixed injection orifice.

Hereinafter, the medical device for forming a liquid communication path according to embodiments of the present invention will be described in detail with reference to the drawings.

(Mode 1) A medical device for forming a fluid communication path according to Modality 1 of the present invention can be applied, for example, to a medical cone device for connecting tubes in peritoneal dialysis. First, a sketch of the medical conne device of this embodiment will be described with reference to Figures 1 A to 2B. FIG. 1A is a perspective view showing a male conne 1 and a protective cap 2 in a separate state, which make up the medial conne device. Fig. 1 B is a perspective view showing a connected state of the male conne 1 and the protective cap 2 in Figure 1 A. Fig. 2A is a perspective view showing a female conne 3 which composes the medical conne device. Fig. 2B is a perspective view showing a state in which the male conne 1 in Fig. 1A and the female con- ce 3 in Fig. 2A are connected.

In this embodiment, the male conne 1 is used as a patient side conne and the female conne 3 is used as a side bag conne that is provided in a dialysis solution bag. The male conne 1, the protective cap 2 and the female conne 3 are all made of a resin.

As shown in Figure 1A, a tube 4 is attached to the rear end portion of the male conne 1. The tube 4 is connected, for example, to a peritoneal catheter that is implanted in the patient's abdominal cavity. A fastener 5 for handling the male connector 1 is provided on the front of the tube 4 and on the front end side of the fastener 5 a band is formed with the protective cap 2 and the female connector 3. The joint includes a portion 6 cylindrical and a small diameter portion 7 having a diameter slightly smaller than the cylindrical portion 6. A threaded notch 6a is formed in the outer circumferential surface of the cylindrical portion 6. There is a step at the base of the portion indian cylinder 6 due to the presence of a large diameter portion 6b. An elastic ring 8 functions as a sealing member and is placed in contact with the large diameter portion 6b.

The protective cap 2 is substantially of the shape of a cylinder with a closed end. As shown in Figure 1 B, the protective cap 2 may be attached to the exterior of the front end portion of the male connector 1. As will be described later with reference to cross-sectional views, a germicidal impregnated member that is impregnated with a germicide (e.g., a povidone iodine solution) is maintained at the bottom of the protective cap 2. A protuberance coupling (as will be described later) is formed on the inner circumferential surface of the protective cap 2. When the protective cap l is attached to the male connector 1, the coupling protrusion engages with the threaded notch 6a to secure the connection between the male connector 1 and the protective cap 2.

The female connector 3 is connected, for example, to the end of a circuit of a peritoneal dialysis system such as double bag, set Y, or APD. As shown in Fig. 2A, a tube 9 is attached to the rear end portion of the female connector 3. A fastener 10 for driving the female connector 3 is provided on the front of the tube 9 and on the front side of the connector. end of the fastener 1 0 a joint is formed with the male connector 1. The j ost is placed inside an external cylinder 1 1. A coupling boss 12 is formed on the inner circumferential surface of the outer cylinder 1 1. When the female connector 3 is connected to the male connector 1, the coupling protrusion 1 2 engages with the threaded notch 6a to secure the connection between the male connector 1 and the female connector 3. The coupling protrusion formed on the inner circumferential surface of the protective cap 2 is the same as the coupling protrusion 1 2.

The male connector 1 is inserted into the outer cylinder 1 1 and then the coupling protrusion 1 2 is screwed into the threaded groove 6a, so that the male connector 1 and the female connector 3 are connected and clamped, as shown in FIG. Figure 2B. When the male connector 1 and the female connector 3 are connected, the tubes 4, 9 communicate with each other by means of a flow path that passes through the internal cavities of the male connector 1 and the female connector 3. In the Figure 2 B, the female connector 3 is inverted from left to right with respect to Figure 2A.

This embodiment is characterized by a configuration related to the combination of the male connector 1 and the protective cap 2, as will be described later. Therefore, the structures of the male connector 1 and the protective cap 2 will be described in more detail with reference to Figures 3A to 5C. First, the structure of the protective cover 2 will be described.

Figure 3A is a front view of the male connector 1 of Figure 1 A. Figure 3B is a right side view of the male connector 1 of Figure 3A. Figure 3C is a cross-sectional view of the male connector 1 of Figure 3A. As shown in Figure 3C, the male connector 1 is divided into the indian cylindrical portion 6, an internal member 1 3 placed in the internal cavity of the cylindrical portion 6 and the fastener 5 attached to the rear portion of the portion. cylindrical 6. The rear end portion of the inner member 1 3 extends into the fastener 5 and forms a connecting pipe portion 1 3a, to which the pipe 4 is connected. In addition, the internal cavity of the inner member 1 3 forms a flow path 1 3b.

A closure valve 14 (eg, a rubber septum with a slit) is provided in the end front portion of the internal cavity of the cylindrical portion 6 to close the internal cavity. An eyebrow 15 is provided on the inner circumferential surface of the end face portion of the cylindrical portion 6 and defines an aperture that is smaller than the outer diameter of the closure valve 14. Accordingly, the shut-off valve 14 is maintained between the front end of the inner member 1 3 and the eyebrow 1 5. The eyebrow 1 5 has a rib 1 5a extending to the front end of the male connector 1.

The shut-off valve 14 has the function of hermetically sealing the flow path in the internal cavity of the inner member 1 3 when the male connector 1 is not connected to the female connector 3. Therefore, the shut-off valve 14 can prevent bacteria enter the flow path from the outside of the male connector 1. In addition, the shut-off valve 14 can also prevent leakage of liquid from inside the flexible tube 4. Thus, the shut-off valve 14 is effective to ensure the tightness of the flow path in the internal cavity of the inner member 13, but not essential. The other methods can be used to ensure airtightness.

Due to the eyebrow 15 provided on the inner circumferential surface of the cylindrical portion 6, the shut-off valve 14 can be easily maintained in the flow path and it is also not likely to be touched with a finger from the front side of the male connector 1. Since the rib 15a is formed in the eyebrow 15, these effects can be further increased.

Figure 4A is a front view of the protective cap 2. Figure 46 is a right side view of the protective cap 2 of Figure 4A. Figure 4C is a cross-sectional view taken along line A-A of Figure 4A. Figure 4D is a cross-sectional view taken along line 6-B of Figure 4B.

As shown in Figures 4C and 4D, the protective cap 2 includes an outer cylinder 16 that is substantially in the shape of a cylinder with a closed end and an internal member 17 that is accommodated in the outer cylinder 16. A portion is provided 16a of reduced diameter having a diameter smaller than the opening in the bottom of the protective cap 2 and the member 18 impregnated with germicide is placed in the portion 16a of reduced diameter. An inner end portion 17a of the inner member 17 restricts the member 1 8 impregnated with germicide so that it is maintained at the bottom of the protective cap 2. Since the protective cap 2 includes the portion 1 6a of reduced diameter into which the member 1 8 impregnated with germicide is inserted, the member 1 8 impregnated with germicide can easily be maintained in the protective cap 2. Furthermore, the member 1 8 impregnated with germicide is not likely to make contact with the front end portion of the male connector 1.

The inner member 1 7 has a coupling protrusion 1 7b formed on the inner circumferential surface of the end portion near the opening. The coupling protrusion 1 7b is screwed into the threaded groove 6a provided in the inner circumferential surface of the male connector 1, so that the male connector 1 and the protective cap 2 are connected. This screw connection structure limits the deepest position of the connection between the male connector 1 and the protective cap 2. Therefore, when the male connector 1 and the protective cap 2 are to be connected, the connection structure of The screw functions as a position limiting element which limits the position of the male connector 1 moving towards the bottom in the protective cover 2.

The inner member 1 7 has an annular eyebrow 1 7c formed on the inner circumferential surface of the middle portion. The annular eyebrow 1 7c functions as a limitation element as described above. The male connector 1 is provided with a contact portion 6b having an outer diameter larger than the inner diameter of the annular eyebrow 1 7c on the outer surface of the front end portion. Therefore, when the protective cap 2 is attached to the male connector 1, the mobile position of the male connector 1 is limited by the contact between the annular eye 17c and the contact portion 6b.

The member 18 impregnated with germicide can be made of a porous or fibrous material such as a sponge. The member 1 8 impregnated with germicide can be impregnated with any germicide different from the povidone iodine solution. However, the povidone iodine solution is preferred in view of the effect on the human body.

Then, a state and an action will be described when the protective cap is attached to the male connector 1, with reference to Figures 5A to 5C. Fig. 5A is a cross-sectional view showing the male connector 1 and the protective cap 2 that are separated, as shown in Fig. 1 A. Fig. 5B is a front view showing the male connector 1 and the protective cap 2 that are connected, as shown in Figure 1 B. Fig. 5C is a cross-sectional view showing the male connector 1 and the protective cap 2 in Fig. 5B.

The protective cap 2 is attached to the male connector 1 to protect the end of the protector when the male connector 1 is not connected to the female connector 3. For the attachment of the protective cap 2 to the male connector 1, as shown in Figure 5A, the front end of the male connector 1 is placed opposite the opening of the protective cap 2 and then the male connector 1 is pushed and twisted in the cap protective 2. Accordingly, the protective cap 2 is attached and fixed to the end front portion of the male connector 1 via the coupling between the coupling protrusion 1 7b formed on the inner circumferential surface of the protective cap 2 and the threaded groove 6a provided on the inner circumferential surface of the male connector 1.

In this case, as described above, the annular eyebrow 1 7c formed on the inner circumferential surface of the inner member 1 7 of the protective cap 2 functions as the position limiting element, as well as the structure that limits the deepest position of the screw connection between the male connector 1 and the protective cap 2 functions as the position limiting element. Therefore, a space 1 9 is formed between the circumference of the front end portion of the male connector 1 and the inner surface of the protective cap 2 (see Figure 5C). This space 1 9 ensures that the member 1 8 impregnated with germicide in the protective cap 2 that faces the front end of the male connector 1 without any contact between them and remains a distance away from the male connector 1.

In addition, the elastic ring 8 is pressed between the outer circumferential surface of the male connector 1 and the inner circumferential surface of the protective cap 2, thus maintaining the tightness of the space 1 9. Thus, the iodine sublimates from the impregnated member 1 8 with germicide which is impregnated with the povidone iodine solution and enters the space 1 9 so that the sterilizing action can be exerted sufficiently on the end face portion of the male connector 1 which is sealed in the space 1 9. In the example above, the elastic ring 8 can be accommodated in the protective cap 2 to seal the space 1 9. That is, the elastic ring 8 can have any configuration as long as it is pressed against both the male connector 1 and the protective cap 2 when the protective cap 2 is attached to the male connector 1.

In the case of the connector for a peritoneal dialysis tube it is desirable that the elastic ring 8 be accommodated on the outside of the connector on the patient's side. Although the protective cap and connector provided in the bag of the dialysis solution are designed for single use, the patient-side connector is exchanged every half year. Therefore, the cost of the elastic ring 8 can be reduced. This does not apply to a tube used for other purposes.

As described above, even if the member 1 8 impregnated with germicide is not in direct contact with the front end of the male connector 1, if not spaced a distance from the front end of the male connector 1, a sufficient sterilizing effect can be obtained. This was confirmed by the experimental results described below.

Therefore, in the medical connector device of this embodiment, the front end portion of the male connector 1 can easily be maintained in the sterilized state by the connection of the protective cap 2 to the end front portion of the male connector 1 . further, in this embodiment, since there is a distance between the member 1 8 impregnated with germicide and the front end of the male connector 1, it is possible to avoid filtering the germicide due to the pressure applied to the member 18 impregnated with germicide. This can avoid the problems of the germicide that has leaked out of the germicide-impregnated member 18 between the internal flow path of the connector / conduit from the front end portion of the connector, or leaks out from the joint between the connector and the lid and may cause contamination of the surrounding area.

Next, a structure and an action of the female connector 3 will be described with reference to Figures 6A to 7C. Figure 6A is a front view of the female connector 3 of Figure 2A. Figure 6B is a left side view of the female connector 3 of Figure 6A. Figure 6C is a right side view of the female connector 3 of Figure 6A. Figure 6D is a cross-sectional view of the female connector 3 of Figure 6A.

The female connector 3 includes an inner cylinder 20 having an internal cavity that serves as a liquid flow path and the outer cylinder 11 having an internal diameter larger than the outer diameter of the inner cylinder 20 and is coaxially attached to the outside of the inner cylinder 20. The fastener 10 is provided at the rear end portion of the outer cylinder 11 and attached to the middle portion of the inner cylinder 20. The front end of the outer cylinder 11 is open and an internal member 21 is accommodated in the outer cylinder 11. The coupling boss 12 is formed on the inner circumferential surface of the inner member 21. The inner cylinder 20 has an end front portion 20a of the inner Cylinder extending inside the outer cylinder 11 to the opening and a connecting portion 20b of tube that extends to the rear of the external cylinder 1 1 and is placed inside the fastener 1 0 In turn, a state and an action will be described when the male connector 1 and the female connector 3 are connected, with reference to Figures 7A to 7C. Fig. 7A is a cross-sectional view showing the male connector 1 and the female connector 3 which are separated. Fig. 7B is a front view showing the male connector 1 and the female connector 3 that are connected. Figure 7C is a cross-sectional view showing the male connector 1 and the female connector 3 of Figure 7B.

For the connection between the male connector 1 and the female connector 3, as shown in Figure 7A, the front end of the male connector 1 is positioned opposite the front opening of the female connector 3 and then the male connector 1 is pushed and it is rotated in the female connector 3. Consequently, the female connector 3 is joined and fixed to the end front portion of the male connector 1 via the coupling between the coupling protrusion 1 2 formed on the inner circumferential surface of the female connector 3 and the threaded notch 6a provided on the outer circumferential surface of the male connector 1.

In this case, as the male connector 1 advances towards the female connector 3, the slit of the closing valve 14 provided in the end front portion of the male connector 1 is forced open by the end portion 20a of the inner cylinder end , so that the front end portion 20a of the inner cylinder penetrates the slit and reaches the inside of the male connector 1, resulting in the opening of a flow path.

The male connector 1 can have other shapes for joining the protective cap 2 or the connection with the female connector 3. For example, the male connector can include an internal cylinder and an external cylinder. The internal cylinder has an internal cavity that serves as a path for fluid flow. The external cylinder has a larger internal diameter than the external diameter of the internal cylinder and is coaxially connected to the outside of the internal cylinder. The front end of the inner cylinder is located inside the front end of the outer cylinder. The protective cap and the female connector are attached to the outside of the external cylinder. This configuration can protect the internal cylinder through which the fluid flows, even if the front end portion of the male connector is accidentally touched. Since the bacteria present in the outer cylinder can be annihilated by covering the outer cylinder with the protective cap as described above, the bacteria will not enter the flow path.

Next, the results of the experiments that were conducted to confirm the effect obtained by the attachment of the protective cap 2 to the male connector 1 in the medical connector device of this embodiment will be described. The experiments showed that a sufficient sterilizing effect was obtained, since the enclosed space 9 formed between the circumference of the front end portion of the male connector 1 and the inner surface of the protective cap 2 and was used to maintain the condition wherein the member 1 8 impregnated with germicide faces the front end of the male connector 1 with a distance between them. In addition, the experiments also showed that it was possible to avoid germicidal leakage caused by contact between the germicide-impregnated member 18 and the front end of the male connector 1 and so on to avoid the problem of the germicide entering the internal path of the germicide. Conector / conduit flow from the front end portion of the connector.

[Experiment 1: Verification of Sterilizing Capacity] A check was made to ensure that the effect of killing bacteria present on the front end portion of the male connector 1 was obtained by the povidone iodine solution facing the front end of the male connector 1 without any contact between them.

The experimental method is as follows. First, they used five species of bacteria from Staphylococcus au reus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans as bacterial species of evaluation. The Staphylococcus species were dissolved in a physiological saline solution containing 0.01% Tween 80 (polyoxyethylene sorbitan monooleate). Each of the other bacterial species was dissolved in a physiological saline solution.

Then, 20 μl of a bacterial suspension of 103 CFU was pipetted onto the front end portion of the male connector 1 and the protective cap 2 was attached to the end front portion of the male coil 1. Subsequently, the male connector 1 connected to the protective cap 2 was allowed to stand at a body temperature of 30 to 35 ° C or a low temperature of 1 0 ° C for 3 hours. Then, the protective cap 2 was removed and the male connector 1 was placed in a 10 ml rinsing solution (Fluid D-ST, produced by bioMerieux) and stirred for 30 seconds. Afterwards, the solution was filtered through a filter? 0.45 pm. After repeating this three times, the filter was placed on a SCD agar medium to grow cells at 30-35 ° C and the viable cell count was determined.

In Example 1, based on this embodiment, the member 1 8 impregnated with germicide in the protective cap 2 was impregnated with a 1% povidone iodine solution. In Comparative Example 1, the member 1 8 impregnated with germicide in the protective cap 2 was impregnated with a physiological saline solution in place of the povidone iodine solution.

The results of the experiment will be described with reference to Table 1. In Comparative Example 1, the number of pipetted cells remained unchanged under both temperature conditions. In Example 1, all bacterial species were killed under both temperature conditions. Therefore, the results confirmed that the bacteria present in the front end portion of the male connector 1 were annihilated even if the povidone iodine solution was not in contact with the end face portion of the male connector 1.

[Table 1 ] Species Viable cell count (CFU) bacterial Temperature conditions Low conditions evaluated body (30-35 ° C) temperature (10 ° C) Example 1 Example Example 1 Example Comparative 1 Comparative 1 Staphylococcus 0 2.7 x 103 0 2.5 x 103 aureus Staphylococcus 0 1.1 x 103 0 3.1 x 103 epidermidis Escherichia coli 0 4.2 x 103 0 3.3 x 103 Pseudomonas 0 1.5x 103 0 2.2 x103 aeruginosa Candida 0 5.1 x 103 0 5.3 x 103 albicans Number of pipetted cells [Experiment 2: Mixing test of povidone iodine solution] After removal of the protective cap 2, a liquid was supplied to the connector conduit to verify whether the povidone iodine solution contained in the germicide-impregnated member 18 in the protective cap 2 was mixed with the delivery liquid.

The experimental method is as follows. In Example 2, the protective cap 2 was attached to the end front portion of the male connector 1 and then allowed to stand for 4 hours. Then, the protective cap 2 was removed and the female connector 3 was connected to the male connector 1. Subsequently, 20 ml_ of ultra-pure water was delivered to the tube. This ultra-pure water was analyzed to quantify the effective iodine by redox titration using a 0.02 N sodium thiosulfate solution as a titrant. In Comparative Example 2, the same test was performed on conventional connectors (the front end of each of the conventional connectors was in contact with the povidone iodine solution).

Figure 8 shows the results of the experiment. As can be seen from Figure 8, although the amount of effective iodine in the impregnated member was larger in Example 2 than in Comparative Examples 2A to 2D, the mixing of the povidone iodine solution in the delivery liquid was not it was detected in Example 2.

Therefore, the results confirmed that it was possible to avoid filtration of the povidone iodine solution in the member 1 8 impregnated with germicide containing the member 18 impregnated with germicide so that it was not in contact with the connector.

[Experiment 3: Verification of retention ability of sterilization capacity] The storage period in which the bacteria present in the front end portion of the male connector 1 can be annihilated was confirmed. The experimental method is as follows. The protective cap 2 was attached to the male connector 1. The male connector 1 connected to the protective cap 2 was wound in an aluminum material for packaging and then subjected to accelerated storage at 40 ° C and a relative humidity (RH) of 75%. Subsequently, the changes over time of the amounts of moisture and effective iodine in the povidone iodine solution with which they are important factors for the sterilization capacity were evaluated. The amount of moisture was calculated by measuring a difference between the weight before storage and the weight after storage.

In determining the amount of effective iodine, the protective cap 2 was immersed in 99.5% ethanol overnight. Then, the protective cap 2 was rinsed with ethanol perfectly so that povidone iodine was extracted. Subsequently, the effective iodine was quantitated by redox titration using a 0.01 M sodium thiosulfate solution as the titrant. In this case, a calibration curve of the povidone iodine solution was prepared for each test and the effective amount of iodine from a sample was calculated from the calibration curve. At the same time of the accelerated storage, the storage at room temperature was also examined. Thus, the relationship between accelerated storage and storage at ambient temperature was confirmed based on data on the amount of moisture and the amount of effective iodine.

In addition, a sterilization capacity test was conducted in the same manner as Experiment 1 and a retention period of the sterilization capacity was studied. In the sterilization capacity test, the temperature was established in the range of 30 to 35 ° C and a bacterial species, that is, Staphylococcus epidermidis was used as evaluated bacterial species. In Comparative Example 3, the impregnated member in the protective cap 2 was impregnated with a physiological saline solution in place of the povidone iodine solution.

Figure 9A shows the results of the experiment in the accelerated storage. Figure 9B shows the results of the experiment in storage at room temperature. By comparing the amounts of moisture and effective iodine during the accelerated storage period with those during the storage period at room temperature, storage at room temperature for 12 M (months) corresponds to accelerated storage for 6 W (weeks) and Storage at room temperature for 24 M corresponds to accelerated storage for 1 2 W. Therefore, the results confirmed that the accelerated storage period corresponds to approximately 8 times the storage period at room temperature.

Table 2 shows the results of the sterilization capacity test. According to the results, viable cells were found in 18 W of accelerated storage. Therefore, in Example 3, sufficient sterilization capacity up to 1.5 W of accelerated storage was retained.

[Table 2] Period of viable cell count (CFU) storage Example 3 Comparative Example 3 9 0 6.3 x 103 12 0 2.3 x 103 15 0 3.2 x 103 18 4.4 x 103 4.0 x 103 21 2.8 x 103 6.8 x 103 24 1.1 x 103 4.7 x 103 27 oo 2.7 x 103 * Number of pipetted cells: 1 03 C FU The above results confirmed that since accelerated storage for 1 5 W was comparable to storage at room temperature for approximately two and a half years, the sterilization capacity was retained for approximately two and a half years.

[Experiment 4: Verification of the relationship between concentration of germicide in enclosed space and non-contact sterilization capacity] The experiments were conducted to study a change in sterilization capacity without contact with the concentration of a germicide in an enclosed space. (1) Step 1 First, the next experiment was conducted as Step 1. The germicide was a povidone iodine solution (Example 4). The bacterial species evaluated were 1 03 CFU of Staphylococcus epidermidis. A physiological saline solution was used for comparison with the bacterial species evaluated (Comparative Example 4).

Sponges were impregnated with 1 0 μ ?, 50 μ? , 1 50 μ? and 300 μ? of the povidone iodine solution, respectively. Each of the sponges impregnated with the povidone iodine solution was attached to a plunger pack of a 5 ml syringe and the plunger was adjusted so that the space was 630 ml. 20 μ? of a bacterial suspension of 103 CFU (diluted with a physiological saline solution containing Tween 80 0.01%) on the portion on the opposite side of the sponge (ie, the tapered end of the syringe) and then the syringe was closed. The syringe was allowed to stand at room temperature and the viable cell count was determined after 1 hour. Table 3 shows the results of the experiment.

[Table 3] Amount of Sample Solution Viable cell count (CFU) povidone iodine (μ?) No. Example 4 Comparative Example 4 1 0.6 x 102 1.9 x 103 10 2 1.4 x 102 2.6 x 103 3 3.7 x 102 2.6 x 103 Average 1.9x 102 2.4 x 103 1 0 1.4 x 103 50 2 0 1.4 X 103 3 0 1.8 x103 Average 0 1.5? 103 1 0 2.4 x 103 150 2 0 1.7 x 103 3 0 2.1 X 103 Average 0 2.1 x103 1 0 1.3? 103 300 2 0 1.3 x 103 3 0 1.6 x 103 Average 0 1.4 x 103 Number of pipetted cells: 103 CFU Based on the results of the experiment, the proportion of povidone iodine solution required to kill bacteria for the volume of enclosed space was calculated. When the enclosed space was 630 mm3 at least 50 μ? of the 1% povidone iodine solution was sufficient to kill 1 03 CFU of Staphylococcus epidermidis. (2) Step 2 Then, the following experiment was conducted as Step 2. Sponges were impregnated with 10 μ? , 50μ? , 1 50μ? and 300 μ? of the povidone iodine solution, respectively. Each one of the sponges impregnated with the povidone iodine solution was attached to a plunger pack of a 5 ml syringe and the plunger was adjusted so that the space had an evaluation volume.

In this case, the evaluation volume was set at 630 mm3, 378 mm3, 1 89 mm3 and 1 26 mm3. 20 μ? of a bacterial suspension of 1 03 CFU (diluted with a physiological saline solution containing 0.01% Tween 80) on the opposite side of the sponge (ie, the tapered end of the syringe). The syringe was allowed to stand at room temperature. Then, the count of viable cells was determined at each time of evaluation to study the time to complete the sterilization. Table 4 shows the results of the experiment. In this case, the evaluation time was set at 0.5 hr and 1 hr.

[Table 4] Amount of Sample Time to complete sterilization (hr) solution of No. 0.5 1.0 povidone iodine Viable cell count Viable cell count (CFU) (CFU) Example Example Example Example Comparative Comparative 1 0 1.9 x 103 0 1.3 x 103 10 μ? / 126 mm3 2 26 1.8 x103 0 1.5 x 103 3 322 1.5 x 103 0 1.1 x 103 Average 116 1.7 x 103 0 1.3 x 103 1 42 1.6 x 103 0 1.2 x103 15 μ? / 189 mm3 2 2 2.1 x 103 0 1.0 x 103 3 0 2.0 x 103 0 1.0 x 103 Average 147 1.9 x 103 0 1.1 x 103 1 18 1.9 x 103 0 1.3 x 103 30 μ? / 378 mm3 2 2 2.0 x 103 0 1.2 x103 3 0 2.1 x 103 0 1.4 x 103 Average 6.7 2.0 x10a 0 1.3 x103 1 0 2.2x103 0 1.3 x103 50 μ? / 630 mm3 2 0 1.8 x 103 0 1.4 x 103 3 0 1.6 x 103 0 1.3 X 103 Average 0 1.9 x103 0 1.3 x 103 The above results confirmed that 103 CFU of Staphylococcus epidermidis were killed if the proportion of povidone iodine solution at 10% for the volume of the space was at least 8%.

(Modality 2) A medical device can be applied to form a liquid communication path according to Modality 2 of the present invention, for example, to a connector device used for enteral feeding. A configuration of the connector device for enteral feeding of this modality will be described with reference to Figs. 1 0A to 1 0B.

In enteral feeding liquid materials are administered such as a nutritional supplement, a fluid food and a medication through a tube that extends from the nasal cavity to the stomach or the duodenum of a patient. For the administration of the nutritional supplement or the like, first, the nutritional supplement, or the like, is injected into the medical container. Next, a connector attached to an end of an injection channel assembly that includes a tube is connected to an orifice (liquid supply portion) of the medical container. In addition, the medical container is suspended by means of a hanger with the hole to which the injection channel assembly is connected downwards. Although the medical container is hanging from the hanger, a connector attached to the other end of the injection channel assembly is connected to a connector provided at the end of the patient's tube and the liquid material such as the nutritional supplement in the container is administered to the patient. doctor.

Fig. 1 0A shows a hole 23 of a medical container 22 to which an injection channel assembly is connected. The orifice 23 includes a tubular portion 24 having a liquid feeding vessel through which the liquid material flows and a connector 25 for enteral feeding at the end of the tubular portion 24. connector 25 is connected to a connector (not shown) provided at one end of the injection channel assembly by a luer connection system. The connector 25 and the connector provided at one end of the injection channel assembly constitute the medical device for forming a liquid communication path of this mode.

This enteral feeding connector device further includes a protective cap 26. When the medical container 22 is not in use, the protective cap 26 is attached to the connector 25. Figure 10B shows the internal structure of the protective cap 26. The lid 26 has a cylindrical shape with a closed end. A member 27 impregnated with germicide is maintained at the bottom of the protective cap 26. A sealing member 28 is provided on the inner circumferential surface of the open end of the protective cap 26.

As shown in Figure 2, when the protective cap 26 is attached to the connector 25 a space is formed around the front end of the connector 25 and the germicide-impregnated member 27 faces the front end of the connector 25 with a distance between them. . Further, when the protective cap 26 is attached to the connector 25 the sealing member 28 is pressed between the outer circumferential surface of the connector 25 and the inner circumferential surface of the protective cap 26 thus providing an air-tight structure of the space 29.

As described above, in the enteral feeding container device of this embodiment, the end front portion of the connector 25 can easily be maintained in the sterilized state by attaching the protective cap 26 to the connector 25. Furthermore, since there is space 29 between the member 27 impregnated with germicide and the front end of the connector 25, it is possible to avoid filtering the germicide due to the pressure applied to the member 27 impregnated with germicide. This can avoid the problems that the germicide that has leaked out of the germicide-impregnated member 27 enters the internal flow path of the orifice 23 from the front end portion of the connector 25 or leaks to the exterior and may cause contamination of the area surrounding.

In the above configuration, the protective cap 26 is attached to the connector 25 for enteral feeding provided in the orifice 23 of the medical container 22. However, the same effects can also be obtained by attaching the protective cap to the connector provided at the end. of the patient's tube.

(Modality 3) A medical device can be applied to form a liquid communication path according to Modality 3 of the present invention, for example, to a medical device of mixed injection orifice. A configuration of the mixed injection orifice device of this embodiment will be described with reference to Figures 1 1 A to 1 1 B.

When a drug solution or the like is administered to a patient, a medical mixed injection orifice is used, for example, to inject a drug solution which is different from the main drug solution into the feeding channel to deliver the solution of drug or to sample the liquid flowing through the feeding channel. Therefore, the mixed injection orifice allows an insertion member having no sharp tip to be inserted into an insertion hole formed in a valve so that the above operations can be performed.

A mixed injection orifice 30 shown in Figure 1 1 A is connected to the middle part of a tube 31, which is one of the objects to be communicated. The objects to be communicated are not limited to a bo and can be in any other way. The tube 31 is provided with a seat 32 and a cover 33 is attached to the seat 32. A valve 34 of d iscus having an insertion hole in the center is held by the seat 32 and the cover 33. The seat 32 the valve 34 is supported and the cover 33 is in contact with the valve 34. Thus, the valve 34 is sandwiched between the seat 32 and the cover 33. The cover 33 has an anchor hole in the middle to expose the upper surface of the valve. the central portion of the valve 34. The seat 32 has a hole from side to side leading to the internal cavity of the tube 31.

When an insertion member (not shown), such as a luer, at the end of a syringe is inserted through the valve 34 of the mixed injection orifice 30, the internal cavity of the insertion member communicates with the internal cavity. of the tube 31. Thus, the liquid can be injected and / or sampled. When the luer is removed from the valve 34, the valve 34 closes due to its elasticity. In other words, the medical device for forming a liquid communication path of this embodiment includes the mixed injection orifice device comprised of the mixed injection port 30 and the insert member.

The mixed injection orifice device further includes a protective cap 35. When the mixed injection orifice 30 is not used, the protective cap 35 is attached to the mixed injection orifice 30.

Figure 1 1 B shows the internal structure of the protective cap 35. The protective cap 35 has a cylindrical shape with a closed end. A member 36 impregnated with germicide is maintained at the bottom of the protective cap 35. A sealing member 37 is provided on the inner circumferential surface of the open end of the protective cap 35.

When the protective cap 35 is joined to the mixed injection orifice 30, a space is formed around the upper end of the mixed injection orifice 30 and the germicide-impregnated member 36 faces the upper end of the mixed injection orifice 30 with a distance between them. Further, when the protective cap 35 is attached to the mixed injection orifice 30, the sealing member 37 is pressed between the outer circumferential surface of the mixed injection port 30 and the internal circumscribing surface of the protective cap 35, thus providing a air-tight structure of space.

As described above, the mixed injection orifice device of this embodiment, the upper end portion of the mixed injection orifice 30 can easily be maintained in the sterilization state by attaching the protective cap 35 to the mixed injection orifice 30. In addition, since there is a space between the member 36 impregnated with germicide and the upper end of the mixed injection orifice 30, it is possible to prevent germicidal filtration due to the pressure applied to the member 36 impregnated with germicide. This can avoid the problems that the germicide that has leaked out of the germicide-impregnated member 36 into the internal flow path of the tube 31 from the end front portion of the mixed injection orifice 30, or leaks out and may cause contamination of the surrounding area.

Figure 12 is a perspective view showing another aspect of the mixed injection orifice device of this embodiment. The same components as those of the mixed injection orifice device of Figure 11A are indicated by the same reference numerals and the explanation will not be repeated. In this aspect, the mixed injection orifice 30 is attached to one end of the tube 31. Even with this aspect, the same effects can also be obtained using the same protective cap as described above.

Industrial Applicability In the medial device for forming a fluid communication path of the present invention, the end face portion of the connecting member can be sufficiently sterilized by attaching the protective cap that holds the germicide impregnated member to the bottom of the connecting member.

In addition, it is possible to prevent germicidal leakage caused by contact between the end face portion of the connecting member and the germicide impregnated member. Thus, the present invention is useful for a connector device or the like to connect flow paths that are used, for example, in dialysis or peritoneal transfusion.

Description of Reference Numbers 1 Male connector 2, 26, 35 Protective cover 3 Female connector 4, 9, 31 Tube 5, 10 Bra 6 Cylindrical portion 6a Threaded notch 6b Contact portion 7 Front portion of small diameter 8 Elastic ring 11, 16 External cylinder 12, 17b Coupling boss 13, 17, 21 Inner member 13th Portion of connection tube 13b Flow path 14 Shut-off valve 15 Eyebrow 15th Rib 16a Reduced diameter portion a Internal end portion c Annular eyebrow , 27, 36 M member impregnated with germicide , 29 Space Internal cylinder a Front end portion of external cylinder b Portion of pipe connection Internal member Medical container Orifice Tubular portion Connector for enteral feeding, 37 Sealing member Mixed injection hole Seat Cover Valve

Claims (14)

1. A medical device for forming a liquid communication path, comprising: connection members that are attached to objects to be communicated, respectively, and form a communication flow path between the objects to be communicated when they are joined; and a protective cap having a cylindrical shape with a closed end, keeps a member impregnated with germicide in a bottom and can be attached to at least one of the connecting members when the connecting members are separated, wherein a dimensional relationship is determined between the at least one of the connecting members and the protective cap so that when the protective cap is attached to the connecting member, an inner circumferential surface of the protective cap forms a space surrounding a front end portion of the connecting member and the germicidal impregnated member faces the end face portion of the connecting member with a distance between them, and wherein a sealing member is provided on an inner circumferential surface of an opening end of the protective cap or on an outer circumferential surface of the connecting member in a location corresponding to the opening end of the protective cap and when the protective cap is attached to the connecting member, the sealing member is pressed between the outer circumferential surface of the connecting member and the inner circumferential surface of the protective cap, thus providing a structure of the air-tight space.

2. The medical device for forming a fluid communication path according to claim 1, wherein one of the connecting members is a male connector and a portion of a connection is provided which is connected to one of the objects to be communicated. in an end rear portion of the male connector, and the other of the connecting members is a female connector and a connecting portion is provided which is connected to the other of the objects to be communicated at a rear end portion of the female connector.

3. The medical device for forming a liquid communication path according to claim 2, wherein the male connector comprises an internal cylinder having an internal cavity that serves as a liquid flow path and an external cylinder having a diameter internal more gland than an outer diameter of the inner cylinder and is coaxially even outside the internal cylinder, a front end of the inner cylinder is located in an interior of a front end of the external cylinder, and the protective cap and the female connector are attached to an exterior of the external cylinder.

4. The medical device for forming a liquid communication path according to claim 2, wherein the male connector has a shut-off valve on an end front portion for closing an internal cavity, The female connector comprises an internal cylinder having an internal cavity that serves as a liquid flow path and an outer cylinder having an inner diameter larger than an outer diameter of the inner cylinder and is coaxially connected to the outside of the external cylinder. , so that the male connector can be inserted into the external cylinder so that the male connector and the female connector are connected, and When the male connector and the female connector are connected, a front end of the internal cylinder of the female connector penetrates the shut-off valve and thus opens a flow path.

5. The medical device for forming a liquid communication path according to claim 4, is provided with an eyebrow on an inner surface of the male connector in a location nearer to the front end of the male connector than the closing valve, defining an opening that is smaller than an outer diameter of the shut-off valve.

6. The medical device for forming a fluid communication path according to claim 5, wherein the eyebrow has a rib extending to the front end of the male connector.

7. The medical device for forming a liquid communication path according to any of claims 2 to 6, wherein a position limiting portion is provided within the protective cap and limits a position of the male connector moving towards the bottom in the protective cap to secure the space.

8. The medical device for forming a fluid communication path according to claim 7, wherein the position limiting portion is formed by an annular eyebrow and a contact portion having an outer diameter larger than an internal diameter. of the annular eyebrow is formed on an outer surface of the end face portion of the male connector, and wherein the male connector and the protective cap are connected, the position of the male connector moving to the bottom in the protective cap is limited by the contact between the annular eyebrow and the contact portion.

9. The medical device for forming a liquid communication path according to claim 7, wherein the male connector and the protective cap are connected by a screw connection, and

A deeper position of the screw connection between the male connector and the protective cap functions as the position limiting portion and limits the position of the male connector moving towards the bottom in the protective cap.

The medical device for forming a liquid communication path according to claim 2, wherein an inner member fits into the protective cap and allows the germicidal impregnated member to remain at the bottom of the cap. protective eleven . The medical device for forming a liquid communication path according to claim 10, wherein the internal member has a position limiting portion that limits a position of the male connector moving towards the bottom in the protective cap for Secure the space.

12. The medical device for forming a liquid communication path according to claim 2, wherein the protective cap is provided at the bottom with a small diameter portion having a smaller diameter than a cap opening. protective and the member impregnated with germicide is placed in the reduced diameter portion.

The medical device for forming a liquid communication path according to claim 1, wherein one of the objects to be communicated is an orifice of a medical container for injecting a nutritional supplement or the like used for enteral feeding and the other is a set for enteral feeding that includes a tube to connect the medial container and a patient, a connector for enteral feeding that is provided in the hole of the medical container constitutes one of the connecting members, and a connector that is provided at one end of the enteral feeding assembly and is to be connected to the enteral feeding connector constitutes the other of the connecting members.

14. The medical device for forming a liquid communication path according to claim 1, wherein one of the connecting members is a mixed injection orifice, the mixed injection orifice includes a seat that is provided in one of the objects a to be communicated, a disc valve that is supported by the seat from a lower side and has an insertion hole in the center and a cover having an adjustment hole to expose an upper surface of a central portion of the valve and covers a valve rim from an upper side, the other of the connecting members is an insert member that can be inserted into the mixed injection port and has an internal cavity that serves as a liquid flow path, and the protective cap is configured to be attached to the orifice of the fluid. mixed injection. SUMMARY A medical device for forming a liquid communication path includes connection members 1, 3 forming a flow communication path between objects to be communicated when they are joined and a protective cap 2 having a cylindrical shape with a closed end holding a member 18 impregnated with germicide in the bottom and can be attached to at least one of the connecting members when they are separated. A dimensional relationship is determined between the at least one of the connecting members and the protective cap such that the inner circumferential surface of the protective cap forms a space 19 surrounding the end face portion of the connecting member and the impregnated member. with germicide faces the front end portion of the connecting member with a distance between them. A sealing member 8 is provided on the inner circumferential surface of an opening end of the protective cap or on the outer circumferential surface of the connecting member in a location corresponding to the opening end of the protective cap. When the protective cap is attached to the connecting member, the sealing member is pressed between the outer circumferential surface of the connecting member and the inner circumferential surface of the protective cap, thus providing a structure of the air-tight space. The end face portion of the connecting member can be effectively sterilized by attaching the protective cap to the connecting member. In addition, it is possible to prevent germicidal leakage caused by contact between the contact member and the germicidal impregnated member.