Source: http://www.freepatentsonline.com/y2009/0143758.html
Timestamp: 2020-02-20 01:20:09
Document Index: 177197632

Matched Legal Cases: ['art 20', 'art 19', 'art 19', 'art 19', 'art 19', 'art 19', 'art 19']

Communicating Member, Medical Container Using the Same, and Infusion Preparation Tool Set - JMS Co., Ltd.
Communicating Member, Medical Container Using the Same, and Infusion Preparation Tool Set
United States Patent Application 20090143758
A communicating member for a medical container contains a plate member 4 having a first opening 5 and a second opening 6, a first connection port 15 including the first opening 5, a plug 9 that obturates the first opening 5 and a first approximately cylindrical member 19 that is in communication with the first opening 5, a second connection port 16 including the second opening 6 and a barrier member 13 that obturates the second opening 6, and a continuous wall 17 disposed on the plate member 4 on the first approximately cylindrical member 19 side and disposed upright on the plate member 4 such that the continuous wall 17 encloses the first opening 5 and the second opening 6 when the plate member is viewed from above; and the first approximately cylindrical member 19 is provided with a first communication part 20 that has an opening on the second opening 6 side.
Okiyama, Tadashi (Hiroshima, JP)
12/225833
JMS Co., Ltd. (Hiroshima-shi, JP)
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20080051696 Artificial kidney dialysis system February, 2008 Curtin et al.
1. A communicating member for a medical container, the communicating member being able to bring into communication the inside and outside of a main container unit composed of a flexible sheet while being fixed to the main container unit, wherein the communicating member comprises a plate member having a first opening and a second opening, a first connection port including the first opening, a plug that obturates the first opening, and a first approximately cylindrical member that is in communication with the first opening, a second connection port including the second opening and a barrier member that obturates the second opening, and a continuous wall disposed on the plate member on the first approximately cylindrical member side and disposed upright on the plate member such that the continuous wall encloses the first opening and the second opening when the plate member is viewed from above, and the first approximately cylindrical member is provided with a first communicating portion that has an opening on the second opening side.
2. The communicating member according to claim 1, wherein the first connecting port further is provided with a first pedestal that is disposed upright on the plate member so as to be in communication with the first opening, and the plug obturates the first opening by being disposed in a tip portion of the first pedestal.
3. The communicating member according to claim 1, wherein the second connection port further is provided with a second pedestal that is disposed upright on the plate member so as to be in communication with the second opening, and the barrier member obturates the second opening by being disposed in a tip portion of the second pedestal.
4. The communicating member according to claim 1, wherein the first communicating portion is disposed at least in a base portion of the first approximately cylindrical member.
12. The communicating member according to claim 1, wherein a covering member that supports the barrier member further is provided, and the periphery of the surface of the barrier member is covered with the covering member.
13. The communicating member according to claim 1, wherein the second connection port further includes a second approximately cylindrical member disposed upright on the plate member so as to be in communication with the second opening.
15. A medical container comprising: a main container unit composed of a flexible sheet, and the communicating member according to claim 1 that is fixed to the main container unit and is able to bring the inside and outside of the main container unit into communication.
16. An infusion preparation tool set comprising the medical container according to claim 15 and a fluid-sending route that is connectable with the second connection port of the communicating member, wherein the fluid-sending route comprises: a fluid-sending tube, a connecting means that is disposed at one end of the fluid-sending tube, that allows a communicating path that brings the inside of the main container unit of the medical container and the fluid-sending tube into communication to be formed therein, and that can maintain a state of the communicating path being formed, and a needle disposed in the other end of the fluid-sending tube.
17. The infusion preparation tool set according to claim 16, wherein the barrier member of the communicating member is a disc-like valve having a slit, and a tip portion of the connecting means can be inserted into the slit of the barrier member, and the base portion of the connecting means includes a conduit portion that is connected to the fluid-sending tube.
The present invention relates to a communicating member that constitutes a medical container that can store fluid such as medicinal fluid, high-calorie infusion fluid or the like, a medical container using this communicating member, and an infusion preparation tool set containing the medical container and a fluid-sending route connected to the medical container.
Examples of medical containers include a medical container for storing a medicinal fluid for an intravenous drip, a medical container for storing a nutritional supplement (also called “high-calorie infusion fluid”) supplied to the central vein, a medical container for storing nutrients that are supplied to the digestive tract through a catheter inserted via a nostril (also called “enteral nutrition”), etc. Such medical containers are composed of a main container unit made of a flexible sheet and are provided with connection ports such as a fluid discharge port, a mixed injection port and the like that are fixed to the main container unit. The fluid discharge port is provided to discharge the medicinal fluid or the like present in the main container unit out of the main container unit, and the mixed injection port is provided to add a minor component such as insulin or the like to the infusion fluid or the like present in the main container unit (for example, see Patent Documents 1 and 2).
However, the pipes that constitute the aforementioned connection ports have the shape of a long and narrow cylinder as described above. Therefore, once air bubbles enter the space inside the connection ports, it is not easy to remove the air bubbles from the space. Moreover, if air bubbles enter the space inside the mixed injection port, the air bubbles may function as a bung and the small amount of medicinal fluid concomitantly introduced through the mixed injection port cannot be diffused. Such a problem is not limited only to a medical container that stores high-calorie infusion fluid, but it is common among medical containers that use long and narrow tubes that are for use as part of connection ports.
It is a feature of the communicating member of the present invention that the communicating member is for use with a medical container and can bring the inside and outside of a main container unit into communication while being fixed to the main container unit composed of a flexible sheet; and the communicating member includes a plate member that has a first opening and a second opening, a first connection port including the first opening, a plug that obturates the first opening, a first approximately cylindrical member that is in communication with the first opening, a second connection port including the second opening and a barrier member that obturates the second opening, and a continuous wall that is disposed on the plate member on the first approximately cylindrical member side and disposed upright on the plate member as if enclosing the first opening and the second opening when the plate member is viewed from above; and the first approximately cylindrical member is provided with a first communication portion that has an opening on the second opening side.
FIG. 1 is a perspective view of an example of the communicating member of the present invention.
It is preferable that in the communicating member of the present invention the first connection port is provided with a first pedestal that is disposed upright on the plate member so as to be in communication with the first opening. In this case, the plug is disposed in the tip portion of the first pedestal and obturates the first pedestal. In this configuration also, although indirectly, the first opening is obturated by the plug. The first pedestal is, for example, tubular or annular.
In Embodiment 1, an example of the communicating member of the present invention and an example of a medical container in which the communicating member is used are described.
As shown in FIG. 2, a plate member 4 that constitutes the communicating member 1 includes a first opening 5 and a second opening 6. A first pedestal 7 and a second pedestal 8 are disposed generally perpendicularly on the plate member 4. The first pedestal 7 is in communication with the first opening 5, and the second pedestal 8 is in communication with the second opening 6. A plug 9 that obturates the opening on the tip side of the first pedestal 7 is provided in the tip portion of the first pedestal 7. The tip portion 7a of the first pedestal 7 is press-fit in an annular depressed portion 9a of the plug 9. Moreover, an annular engagement portion 10 is disposed upright on the plate member 4 such that the annular engagement portion 10 encloses the first pedestal 7, and the annular engagement portion 10 is provided with a hook 10a at its tip. This hook 10a and a hook 11a of a cap 11 into which the plug 9 is inserted are in engagement with each other, and thereby the plug 9 is sandwiched between the first pedestal 7 and the cap 11. The cap 11 covers only the edge of the surface 9b of the plug 9 (the surface opposite the surface facing the inner space of the first pedestal 7). Therefore, a metal needle or a synthetic resin needle (hereinafter referred to also as an “introducer needle”) or the like that has a sharp tip can be inserted into the central part of the plug 9.
On the side opposite the first pedestal 7 side of the plate member 4, a first approximately cylindrical member 19 that is in communication with the first pedestal 7 and the first opening 5 are disposed generally perpendicularly on the plate member 4. As shown in FIG. 1, a part 19a of the peripheral surface of the first approximately cylindrical member 19 shares substantially the same plane as a part of the outer surface of a continuous wall 17. The approximately cylindrical member 19 has sufficient length so that the sheet 2 that constitutes the main container unit 3 (see FIG. 8) does not get broken by a metal needle or an introducer needle that penetrates the plug 9 when the metallic needle or the like is inserted into the plug 9.
As shown in FIG. 2, a barrier member 13 that obturates the opening located on the tip side of the second pedestal 8 is disposed in the tip portion of the second pedestal 8. The shape or other features of the barrier member 13 are not particularly limited. It is preferable that, for example, the barrier member 13 is a disc-like valve that has a linear slit 13a formed in the center. The end face 8a at the tip of the second pedestal 8 is in contact with the periphery of the back surface of the barrier member 13 (the surface facing the inner space of the second pedestal 8) and supports the barrier member 13. A latching projected portion 8b is provided on the peripheral surface of the second pedestal 8. The latching projected portion 8b is engaged with a latching depressed portion 14a provided on the covering member 14 that supports the barrier member 13, and thereby, the covering member 14 is held on to the second pedestal 8. The covering member 14 covers only the edge of the surface 13b of the barrier member 13 (surface opposite the surface facing the inner space of the second pedestal 8). Therefore, for example, the tip part (male luer) of a needle-less syringe 24 can be inserted into the slit of the barrier member 13, and a small amount of medical fluid such as insulin can be injected for mixing, as shown in FIG. 9.
As shown in FIG. 3, if the first approximately cylindrical member 19 is sectioned into a part 19b that is relatively closer to the second opening and a part 19c that is relatively farther, the position where the first communicating portion 20 (see FIG. 1) is provided is not limited in as long as the first communicating portion 20 has an opening in the part 19b that is relatively closer to the second opening 6 (see FIG. 2). It is, however, preferable that, the first communicating portion 20 is provided in a position where the first communicating portion 20 is not blocked by the sheet 2 that constitutes the main container unit 3 of the medical container 100 when the medical container 100 is vibrated or when the medical container 100 is overturned to remove air bubbles entered into the inner space of the first connection port 15. Specifically, it is preferable that an opening is formed in a position within the part 19b that is closer to the second opening on the peripheral surface of the first approximately cylindrical members 19 but not in the part 19a that is on the same plane as the continuous wall 17. In particular, as shown in FIG. 5, it is preferable that, when the communicating member 1 is viewed from above so that the inner space of the first approximately cylindrical member 19 can be seen, the first communicating portion 20 is formed such that the first communicating portion 20 overlaps a part of the line connecting the center of the plug 9 and the center of the barrier member 13. In this case particularly, it is easy to remove air bubbles from the inside of the first connection port 15 and it is unlikely that the sheet that constitutes the main container unit gets broken by a metal needle, plastic needle or the like that has a sharp tip.
Embodiment 2 is an example of an infusion preparation tool set that includes the medical container described in Embodiment 1 and a fluid-sending route that is to be connected to the medical container.
In the fluid-sending route 21, the fluid-sending tube 26 branches off in the middle section and is composed of flexible tubes 26a and a branch connection tube 26b that unites the flexible tubes 26a. Needles 41 (for example, synthetic resin needles or metal needles) that are inserted into the mouth of vials or the like and enable the inside of the vials and the fluid-sending tube 26 to be in communication are disposed at one end of the fluid-sending tube 26. A lock connector 23 is disposed at the other end of the fluid-sending tube 26. The flexible tubes 26a are furnished with clamps 27 that can open or block the passage in the flexible tubes 26a.
Next, the lock connector 23 shall be described in detail with reference to FIG. 11 to FIG. 14.
The lock connector 23 has a conduit portion 30 in the center as shown in the side view presented in FIG. 11. Although only the base portion 30a of the conduit portion 30 is shown in FIG. 11, the conduit portion 30 includes a tip portion 30b as can be understood from the cross-sectional view of FIG. 12. To the base portion 30a is connected the fluid-sending tube 26 (see FIG. 8). The tip portion 30b penetrates the barrier member 13 of the second connection port 16 of the medical container 100 and reaches the inner space of the second connection port 16.
An approximately cylindrical hood 32 is disposed such that the tip portion 30b of the conduit portion 30 is enclosed as shown in FIG. 11 and FIG. 12. The hood 32 on the base side is joined with the axial middle section of the conduit portion 30. The joined portion 33 of the hood 32 and the conduit portion 30 are shown in another side view presented in FIG. 13 or a front view presented in FIG. 14. The hood 32 has a notch 32a on its cylindrical continuous wall as shown in FIG. 13. FIG. 12 shows a cross section taken along the line C-C given in FIG. 13.
In addition to the hood 32, supports 34a, 34b, 35a and 35b are joined with the middle section of the conduit portion 30 and each of these supports extends in the direction perpendicular to the axis of the conduit portion 30 as shown in FIG. 12 and FIG. 14. For viewability, hatching is given to the supports 34a, 34b, 35a and 35b in FIG. 14. In FIG. 11 and FIG. 12, the reference numeral 36 refers to a locking lever. A pair of locking levers 36 are disposed on the lateral part of the conduit portion 30, and each locking lever extends in the axial direction of the conduit portion 30. The middle section of the locking levers 36 is joined with the tip of the supports 34a, 34b, 35a and 35b, thereby being positioned at specific locations relative to the conduit portion 30. The supports 34a and 34b as a pair support one locking lever 36, and the supports 35a and 35b as a pair support the other locking lever 36. Therefore, in a practical sense, a pair of supports are provided per locking lever 36.
The locking levers 36 are provided with locking pieces 36a on the tip side thereof when viewed from the joined portions formed with the supports 34a, 34b, 35a and 35b and are provided with operation pieces 36b on the base side thereof. Each locking piece 36a has at its tip a locking claw 37 that projects inward. Each locking piece 36a is placed within the notch 32a of the hood 32, and as shown in FIG. 13 and FIG. 14, the outer surface of the locking levers is arranged to be substantially on the same plane as the outer surface of the hood 32. Since the notch 32a is closed on the tip side, the tip of the locking pieces 6a of the locking levers 6 is enclosed by the hood 32 when viewed from above, thereby reducing the possibility of coming into contact with other objects when used.
By applying a pressure in the direction of the conduit portion 30 to the operation pieces 36b of the locking levers 36, i.e., by applying a force as if pinching the operation pieces 36b of the pair of locking levers 36 shown in FIG. 11 or FIG. 12, the supports 34a, 34b, 35a and 35b are deformed resiliently. Thereby, the locking levers 36 are moved around near the joined portions formed with the supports 34a, 34b, 35a and 35b, and the space between the pair of locking claws 37 becomes larger.
Moreover, grippers 32b that are formed by partially flattening the cylindrical surface are provided on the base side of the hood 32 as shown in FIG. 11 and FIG. 13. These grippers 32b are provided for enhancing the ease of operation such that when the connector is connected, these grippers are held.
As described in Embodiment 1, the tip portion 30b of the conduit portion 30 of the lock connector 23 can be inserted into the inner space of the second pedestal 8. The covering member 14 is provided at the tip of the second pedestal 8 with the barrier member 13 being interposed. The barrier member 13 obturates the tip portion of the second pedestal 8, and is held by the tip of the second pedestal 8 and the inner surface of the distal projected portion 14b of the covering member 14. In order to ensure that the barrier member 13 is held securely, a projection 8b is formed at the tip of the second pedestal 8, a projection 14c is also formed on the inner surface of the distal projected portion 14b of the covering member 14, and the barrier member 13 is sandwiched by the projection 8b and the projection 14c.
As shown in FIG. 3, two annular projected portions are disposed on the peripheral surface of the covering member 14, and thereby, the second connection port has the first protrusion 14d and the second protrusion 14e. The locking claws 37 formed on the locking pieces 36a of the lock connector 23 can be engaged with the first and second protrusions 14d and 14e (see FIG. 12 and other drawings). When the locking claws 37 are in the state of engagement with the first protrusion 14d, the lock connector 23 and the second connection port 16 are connected shallowly, and the state in which the tip portion 30b of the conduit portion 30 of the lock connector 23 does not penetrate the barrier member 13 is maintained. When the locking claws 37 are in the state of engagement with the second protrusion 14e, the lock connector 23 and the second connection port 16 are connected deeply, and the state in which the tip portion 30b of the conduit portion 30 of the lock connector 23 penetrates the barrier member 13 is maintained.
Next, a connection operation for the second connection port 16 and the lock connector 23 shall be described. When the lock connector 23 and the second connection port 16 are connected, the tip of each component is faced with each other, and the covering member 14 of the second connection port 16 is inserted into the hood 32 of the lock connector 23. Thereby, the tip portion 30b of the conduit portion 30 of the lock connector 23 contacts the barrier member 13. As shown in FIG. 15A and FIG. 15B, the locking claws 37 of the lock connector 23 then are engaged with the first protrusion 14d of the covering member 14. In this first connected state, the connection of the lock connector 23 and the second connection port 16 is maintained while the tip portion 30b of the conduit portion 30 of the lock connector 23 do not penetrate the barrier member 13 of the second connection port 16. Therefore, the passage of the lock connector 23 and the passage of the second connection port 16 are not in communication.
From this state, the connection of the lock connector 23 and the second connection port 16 is deepened as shown in FIG. 16A and FIG. 16B, and thus it is possible to engage the locking claws 37 of the locking levers 36 and the second protrusion 14e. In this second connected state, the connection of the lock connector 23 and the second connection port 16 is maintained while the tip portion 30b of the conduit portion 30 of the lock connector 23 penetrates the barrier member 13 of the second connection port 16. Therefore, the state in which the passage of the lock connector 23 and the passage of the second connection port 16 are in communication can be obtained.
To disconnect the lock connector 23 and the second connection port 16, a pressure in the direction of the conduit portion 30 is applied to the operation pieces 36b of the lock connector 23. Thereby, supports 34a, 34b, 35a and 35b (see FIG. 14) are deformed resiliently, and the distance between the pair of locking claws 37 is widened. As a result, the locking claws 37 and the first protrusion 14d or the second protrusion 14e are disengaged.
According to the above-described configuration and operation, the lock connector 23 is connected to the second connection port 16 in the first connected state shown in FIG. 15A and FIG. 15B, but the barrier member 13 of the second connection port 16 is not penetrated by the tip portion 30b of the conduit portion 30 of the lock connector 23, and therefore the generation of permanent deformation of the barrier member is avoided even when the infusion preparation tool set is stored for a long period of time.
The infusion preparation tool set may be configured such that the tip portion 30b of the conduit portion 30 of the lock connector 23 contacts the barrier member 13 of the second connection port 16 in the first connected state, and the pressure created thereby partially opens the slit 13a. Thus, it is possible to introduce sterilizing gas in the first connected state.
A position regulating configuration is shown in FIG. 17A and FIG. 17B. This configuration is to prevent the engagement of the locking claws 37 of the lock connector 23 and the first protrusion 14d of the second connection port 16 from being deepened in order to maintain the first connected state shown in FIG. 15A and FIG. 15B securely. The second connection port 16 includes a reduced diameter portion 7b on the side closer to the base than the second protrusion and on the first pedestal side of the plate member 4. When the locking claws 37 of the locking levers 36 and the first protrusion 14d are in engagement, a c-shaped stopper 28 is installed on the reduced diameter portion 7b as a position regulator that prevents the second connected state. The c-shaped stopper 28 installed between the tip of the hood and the plate member 4 has a shape as shown in, for example, FIG. 18. The c-shaped stopper 28 has a shape of a ring with a gap 28b and is installed on the second connection port 16 through the gap 28b. A ring pull 29 is attached to the c-shaped stopper 28 for the ease of handling. The lock connector 23 is position-regulated with the c-shaped stopper 28, and thereby the connection of the second connection port 16 and the lock connector 23 is secured firmly while the barrier member 13 of the second connection port 16 is not penetrated by the tip portion 30b of the conduit portion 30 of the lock connector 23. Moreover, in this state, both the passage of the lock connector 23 and the passage of the second connection port 16 are positioned for communication as shown in FIG. 15A and FIG. 15B, and thus the operation of bringing these passages into communication is very easy.
As described above, it is possible to supply the infusion preparation tool set while the lock connector 23 and the second connection port 16 in the first connected state, and thus it is possible to eliminate the operation of connecting these components when used, and it is possible to prevent the contamination of the inside of the connector that may be caused by the outside contact with the connection parts. Furthermore, when the infusion preparation tool set is used, the lock connector 23 merely is pressed against the second connection port 16, and thus the operation is very simple. To disconnect, the operation pieces 36b merely are held with the fingers. In addition, the locking levers 36 are independent of the hood 32 and supported by the conduit portion 30 via the supports 34a, 34b, 35a and 35b (see FIG. 14). Therefore, a wide margin can be easily provided to resiliently change the position of the locking claws 37 that are provided at the tip of the locking pieces 36a. As a result, a sufficient margin can be secured for the engagement with the first and second protrusion 14d and 14e, and thus a secure engagement can be obtained.
Moreover, since the locking pieces 36a are enclosed completely by the hood 32 and since the outer surface thereof is substantially on the same plane as the outer surface of the hood 32, there is little possibility of the tip of the locking pieces 36a being deformed by an accidental contact with other object, thereby reducing the chances of accidental disengagement. Furthermore, due to the configuration that the tip portion 30b of the conduit portion 30 is housed in the hood 32, the tip portion 30b can be protected from contamination caused by a contact with other object, and thus it is possible to keep the portion that comes into contact with infusion fluid clean.
The communicating member of the present invention can prevent a damage to the main container unit caused by an injection needle or the like inserted into the main container unit through the first connection port and can prevent the retention of air bubbles entered into the inside space of the first connection port, and therefore the communicating member is for use as a component that has a function as a connection port that constitutes a medical container. With a medical container or an infusion preparation tool set in which the communicating member of the present invention is used, it is easy to perform gas-liquid separation in the medical container.
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