JP7845183B2 - Body fluid storage bag - Google Patents

Description

This invention relates to a body fluid storage bag and a body fluid collection device for storing body fluids such as ascites.

In patients with cirrhosis and cancerous peritonitis, fluid may leak from blood vessels, accumulating in the abdominal cavity as ascites. When a large amount of ascites accumulates, it can compress surrounding organs, leading to problems such as loss of appetite, decreased kidney function, and difficulty breathing. On the other hand, ascites contains plasma components that have leaked from the blood, and these plasma components also contain useful proteins such as albumin and globulin.

Therefore, in recent years, a treatment method called CART (Cell-free and Concentrated Ascites Reinfusion Therapy) has been proposed, in which ascites fluid extracted from a patient is filtered and concentrated, and the beneficial components are returned to the patient (see, for example, Patent Document 1). More specifically, in this CART method, ascites fluid extracted from the patient is collected in a storage bag, and this storage bag is connected to a CART circuit that includes a filter and a concentrator. As the ascites fluid in the storage bag passes through the filter and concentrator, bacteria and cancer cells are removed, and beneficial components such as albumin are concentrated. The ascites fluid thus processed is then returned to the patient by intravenous drip or other means.

A storage bag for storing bodily fluids such as ascites is known, as shown in Patent Document 2. The storage bag (1) disclosed in Patent Document 2 comprises a bodily fluid storage member (2), a bodily fluid outflow tube (3), and a mesh-like filter (6). This filter captures fibrin in the ascites and prevents it from flowing out.

Japanese Patent Publication No. 2019-134984 Japanese Utility Model Publication No. 02-15149

However, in the case of a fluid storage bag like the one described in Patent Document 2, there is a problem that ascites fluid tends to remain at the bottom of the bag, reducing the amount of ascites fluid that can be processed relative to the amount drained from the patient. Furthermore, there is a problem that the filter can become clogged or stick to the inner surface of the bag, reducing the effective surface area of the filter. In addition, there is a need for a fluid storage bag that is easier to use than conventional bags.

Therefore, the purpose of this disclosure is to provide a body fluid storage bag that can achieve at least one of the following: reducing the amount of body fluid remaining in the bag, ensuring stable filtering, and improving ease of use.

Furthermore, in CART, when initially collecting body cavity fluids such as ascites from the patient, a collection bag is connected to the outer end of the catheter extending from the patient's body cavity to the outside of the body via a body cavity fluid collection device consisting of a tube and a drip chamber. By positioning this collection bag vertically below the patient, gravity is used to collect the patient's body cavity fluid into the collection bag. When administering intravenous fluids to a patient, the completion time can be determined by visually observing the fluid volume in the electrolyte bag. However, when collecting body cavity fluids, the remaining amount of fluid in the body cannot be visually observed. Therefore, it is necessary to observe the drip rate of the body cavity fluid in the drip chamber to determine the completion time of collection.

However, if the patient changes position or the position of the collection bag changes during the collection of body fluid, the drip chamber may become filled with body fluid. For example, unlike known blood transfusion circuits, in body fluid collection, the collection bag is placed below the patient lying on the bed. Then, the collection bag needs to be lifted to check the volume or replace it with a new bag during the collection of body fluid. At that time, there are unique challenges in that the movement of parts of the circuit other than the drip chamber can cause the fluid level to rise and the drip chamber to become filled with body fluid, or the drip chamber may be tilted, causing air to be trapped in the lower tube and the drip chamber to become filled with body fluid. If this happens, it becomes impossible to check the drip rate of the body fluid and it becomes impossible to know when the collection is complete.

Therefore, this disclosure also aims to solve any of the above-mentioned problems specific to body fluid collection devices.

A first embodiment of the bodily fluid storage bag according to the present disclosure comprises a bag body made of a flexible sheet for storing bodily fluids inside, a suspension portion provided at one end of the bag body for suspending the bag body, a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the bodily fluid moving from the first chamber to the second chamber, and an outlet portion extending into the second chamber through which the bodily fluids inside the bag body flow out, wherein the bag body has a first inclined edge portion and a second inclined edge portion at the other end, which are inclined with respect to the vertical line that divides the bag body when it is suspended, and at least a part of the outlet portion in the second chamber extends in a direction intersecting the vertical direction.

This allows the liquid level to be raised by having the first or second inclined edge, and even if the length of the outlet is increased, the outlet is less likely to be exposed above the liquid level of the contents. Therefore, the amount of bodily fluid remaining inside the bag can be reduced, and more bodily fluid can be efficiently discharged through the outlet.

Furthermore, in the second embodiment of the bodily fluid storage bag according to the present invention, the outflow portion may be provided on the first inclined edge such that the outlet faces downward.

This allows the outflow section to be configured such that at least a portion of it extends in a direction intersecting the vertical direction when the bag body is suspended, without requiring the outflow section to have a special shape.

A third embodiment of the bodily fluid storage bag according to the present disclosure comprises a bag body made of a flexible sheet for storing bodily fluids inside, a suspension portion provided at one end of the bag body for suspending the bag body, a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the bodily fluid moving from the first chamber to the second chamber, and an outlet portion that communicates with the second chamber and through which the bodily fluid inside the bag body flows out, wherein the bag body has a first inclined edge portion and a second inclined edge portion at the other end, which are divided by a vertical line when the bag body is suspended, and the outlet portion is provided at the first inclined edge portion, and further the bag body has a third inclined edge portion that connects the first inclined edge portion and the second inclined edge portion and is inclined toward the connection point of the outlet portion.

As a result, with the bag suspended, the bodily fluids stored inside are smoothly guided to the outlet along the first or second inclined edge, and further along the third inclined edge. Therefore, the amount of bodily fluid remaining inside the bag can be reduced, and more bodily fluids can be processed.

A fourth embodiment of the bodily fluid storage bag according to the present disclosure comprises a bag body made of a flexible sheet for storing bodily fluids inside, a suspension portion provided at one end of the bag body for suspending the bag body, a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the bodily fluid moving from the first chamber to the second chamber, and an outlet portion that communicates with the second chamber and through which the bodily fluid inside the bag body flows out, wherein the bag body has a first inclined edge portion and a second inclined edge portion at the other end, which are divided by a vertical line when the bag body is suspended, and the edge portion of the filter extends in a direction inclined with respect to both the first inclined edge portion and the second inclined edge portion.

This ensures that even when the amount of bodily fluid remaining in the storage bag decreases, a large effective surface area of the filter in contact with the remaining fluid can be secured, allowing for reliable removal of foreign matter by the filter even when the remaining amount is small.

Furthermore, in the fourth embodiment of the bodily fluid storage bag according to the fifth aspect of this disclosure, the edge of the filter may extend in a direction that intersects with and is not perpendicular to the direction along the vertical direction when the bag body is suspended.

This allows for a larger length dimension to be secured for the portion located within the second chamber at the outlet.

Furthermore, in the sixth embodiment of the bodily fluid storage bag according to the present disclosure, in the fourth or fifth embodiment, further comprises an inlet that communicates with the first chamber and through an inlet into the bag body through which bodily fluid flows, the inlet and the outlet are provided on the first inclined edge, and the edge of the filter may extend from between the connection point of the inlet and the connection point of the outlet on the first inclined edge.

This aligns the direction of the inlet and outlet, resulting in a more compact design that improves storage in containers and prevents the outlet from touching the floor or other surfaces during inflow, thus preventing contamination.

A bodily fluid storage bag according to a seventh aspect of the present disclosure comprises a bag body made of a flexible sheet for storing bodily fluids inside, a suspension portion provided at one end of the bag body for suspending the bag body, a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the bodily fluid moving from the first chamber to the second chamber, and an outlet portion that communicates with the second chamber and through which the bodily fluid inside the bag body flows out, wherein the bag body has a first inclined edge portion and a second inclined edge portion at the other end, which are divided by a vertical line when the bag body is suspended, and the filter is bag-shaped and encloses the portion of the outlet portion located inside the second chamber, and is fixed to the bag body at least at the first inclined edge portion and the second inclined edge portion.

This ensures that the filter maintains a stable position within the storage bag, preventing it from sticking to the inner surface of the bag and allowing the filter to perform reliably.

The eighth embodiment of the bodily fluid storage bag according to the present disclosure comprises a bag body made of a transparent flexible sheet for storing bodily fluids inside, a suspension portion provided at one end of the bag body for suspending the bag body, a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the bodily fluid moving from the first chamber to the second chamber, and an outlet portion connected to the other end of the bag body, communicating with the second chamber, through which the bodily fluid inside the bag body flows out, wherein the main surface of the bag body is marked with a residual scale indicating the amount of bodily fluid remaining inside the bag body when the bodily fluid flows out from the outlet portion, the residual scale having a plurality of first scale lines perpendicular to the vertical direction when the bag body is suspended in a first suspension position with the outlet portion facing downwards, and a plurality of second scale lines perpendicular to the vertical direction when the bag body is suspended in a second suspension position different from the first suspension position with the outlet portion facing downwards.

For example, if the bag body is rectangular, it may be used in a manner where the suspension position differs depending on the amount of fluid remaining. For instance, if there is a large amount of fluid remaining, it may be gripped at the two corners at the top, and if the amount of fluid remaining decreases, it may be gripped at the single corner at the top. In this case, the above configuration provides scale lines corresponding to each suspension position, allowing for accurate determination of the amount of fluid remaining regardless of the suspension position, thus realizing a fluid storage bag that is easy to use in any position.

Furthermore, in the ninth embodiment of the fluid storage bag according to the present disclosure, in the eighth embodiment, the plurality of first scale lines may decrease in length from one end to the other end, and the plurality of second scale lines may increase in length from one end to the other end.

This allows the amount of bodily fluid remaining to be determined by positioning the bag in the first suspension position, using the longer first scale line at one end as a guide, when there is a large amount of bodily fluid remaining. Conversely, when the amount of bodily fluid remaining decreases, the amount of bodily fluid remaining can be determined by positioning the bag in the second suspension position, using the longer second scale line at the other end as a guide.

Furthermore, in the tenth embodiment of the present disclosure, the fluid storage bag includes, in the eighth or ninth embodiment, a plurality of first and second graduation lines, which are paired first and second graduation lines indicating the same residual amount, and the proximal ends of the paired first and second graduation lines may be connected.

This makes it easier to identify the paired first and second grid lines.

A fluid storage bag according to the eleventh aspect of the present disclosure comprises a bag body made of a transparent, flexible sheet for storing fluid inside, a suspension portion provided at one end of the bag body for suspending the bag body, a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the fluid moving from the first chamber to the second chamber, an inlet connected to the other end of the bag body and communicating with the first chamber, through which fluid flows into the bag body, and a portion connected to the other end of the bag body, The bag comprises an outlet that communicates with a second chamber and through which bodily fluids from the bag body flow out, and one main surface of the bag body is provided with a storage scale that indicates the amount of bodily fluids stored in the bag body when bodily fluids are introduced from the inlet, and an inflow direction indicator that indicates the direction in which bodily fluids flow in from the inlet, and the other main surface of the bag body is provided with a residual scale that indicates the amount of bodily fluids remaining in the bag body when bodily fluids are introduced from the outlet, and an outflow direction indicator that indicates the direction in which bodily fluids flow out from the outlet.

This makes it easy to understand the correct orientation of the bag and the reference markings to use when adding or removing bodily fluids from the bag, resulting in a user-friendly bodily fluid storage bag.

A fluid storage bag according to a twelfth aspect of the present disclosure comprises: a bag body made of a transparent, flexible sheet for storing fluid inside; a suspension portion provided at one end of the bag body for suspending the bag body; a filter that divides the inside of the bag body into a first chamber and a second chamber and removes foreign matter from the fluid moving from the first chamber to the second chamber; an inlet connected to the other end of the bag body, communicating with the first chamber, through which fluid flows into the bag body; and an outlet connected to the other end of the bag body, communicating with the second chamber, through which fluid flows out of the bag body. The main surface of the bag body is provided with color indicators that point to objects to be connected to the inlet and outlet.

This makes it easy to determine whether the tubes in the circuit should be connected to the inlet or outlet when connecting a fluid storage bag to a CART circuit.

A body fluid collection device according to a thirteenth aspect of the present disclosure is a body fluid collection device for collecting body fluid from the abdominal cavity or thoracic cavity of a patient, comprising: a collection tube whose upstream end is connected to a catheter extending from the patient; and a drip chamber having an inlet to which the downstream end of the collection tube is connected, a storage space for temporarily storing body fluid flowing in from the inlet, and an outlet for discharging the body fluid stored in the storage space, wherein the collection tube or the drip chamber is provided with an air inlet for introducing air into the storage space.

This allows the amount of fluid in the drip chamber to be reduced by introducing air into the reservoir through the air inlet, even if the volume of fluid in the drip chamber becomes large. Therefore, the fluid level in the drip chamber can be easily restored and adjusted.

Furthermore, in the thirteenth embodiment of the body cavity fluid collection device according to the present disclosure, an air introduction tube for passing air is connected to the air inlet, and the air introduction tube may be provided with an opening/closing device or a hydrophobic filter for restricting the flow of body cavity fluid.

This allows for the introduction of air into the drip chamber while preventing leakage of body fluid from the body fluid collection device.

Furthermore, in the 14th embodiment of the body fluid collection device according to the 15th aspect of this disclosure, the air introduction tube may be provided with a connector for connecting to a syringe or pump.

This allows for easy connection of a syringe or pump to the body fluid collection device, enabling the introduction of air into the drip chamber.

The fluid storage bag according to this disclosure can reduce the amount of fluid remaining in the bag, provide a stable filter function, and realize a user-friendly and useful fluid storage bag. Furthermore, the fluid collection device according to this disclosure allows for easy recovery of the fluid level in the drip chamber and easy adjustment of the fluid level, even if the drip chamber is filled with fluid and the fluid level is lost, by checking the contents of the storage bag below the patient or replacing the bag during fluid collection.

Figure 1 is a schematic diagram of a CART circuit in which the fluid storage bag according to this embodiment 1 is used. Figure 2 is a front view of the fluid storage bag. Figure 3 is a cross-sectional view taken along line III-III with body fluids stored in the body fluid storage bag shown in Figure 2. Figure 4 is an exploded perspective view of the fluid storage bag. Figures 5(a) and 5(b) are plan views showing the manufacturing process of a body fluid storage bag. Figures 6(a) and 6(b) are cross-sectional views showing the manufacturing process of a body fluid storage bag. Figure 7 is a front view from one side of a fluid storage bag, showing in detail the scale on one of its main surfaces. Figure 8 is a front view from the other side of the fluid storage bag, showing in detail the scale on the other main surface. Figure 9 is a schematic diagram of a body fluid storage bag showing the state of body fluids stored inside the bag body in the first suspension position. Figure 10 is a schematic diagram of a body fluid storage bag showing the state of body fluids stored inside the bag body in the second suspension position. Figure 11 is a schematic diagram of a CART circuit for processing body cavity fluid collected by the body cavity fluid collection device according to this second embodiment. Figure 12 is a schematic diagram illustrating the sampling process. Figure 13 is a diagram showing a body fluid collection device. Figure 14 is a cross-sectional view showing a magnified portion of the body fluid collection device shown in Figure 13. Figure 15 is a diagram showing the configuration of a body fluid collection device according to Embodiment 3.

(Embodiment 1)
In this first embodiment, a fluid storage bag used in a CART circuit to store ascites fluid will be described as an example. However, the fluid storage bag is not limited to one that stores ascites fluid; it may also store pleural effusion or other fluids, or it may be used in a fluid transfer set other than a CART circuit.

[CART circuit]
Figure 1 is a schematic diagram of a CART circuit using a fluid storage bag according to Embodiment 1 of the present disclosure. As shown in Figure 1, the CART circuit 100 consists of a flexible tube through which ascites fluid flows from the fluid storage bag 1 through the filter 2 and concentrate 3 to the recovery bag 4. Specifically, a line L1 for ascites fluid flows from the fluid storage bag 1, which is suspended from a hanging fitting F provided at the tip of a stand, etc., through the first pump P1 to the bottom of the filter 2. Partway along this line L1, between the fluid storage bag 1 and the first pump P1, a line extending from a bag 5 containing physiological saline solution joins it. Also partway along line L1, between the first pump P1 and the filter 2, a line extending from a pressure gauge 6 that measures the pressure of the ascites fluid flowing through line L1 joins it.

From the side of filter 2, line L2, through which ascites fluid from which foreign matter has been removed by filter 2 flows, extends to the bottom of concentrator 3 via the second pump P2. From the top of concentrator 3, line L3, through which ascites fluid concentrated by concentrator 3 flows, extends to the inlet port of recovery bag 4. Furthermore, from the outlet port of recovery bag 4, line L4 extends to circulate the concentrated ascites fluid in order to further concentrate it, and this line L4 merges with line L2 between filter 2 and the second pump P2.

Meanwhile, a line L5 extends from the top of filter 2 to appropriately discharge foreign matter removed from the ascites fluid by filter 2. Furthermore, a line L6 extends from the side of concentrator 3 to appropriately discharge water removed from the ascites fluid by concentrator 3.

In this CART circuit 100, the ascites fluid collected from the patient and stored in the fluid storage bag 1 is filtered to remove unwanted components by the filter 2 and concentrated to an appropriate concentration by the concentrate 3, becoming filtered and concentrated ascites fluid which is then collected in the recovery bag 4. The filtered and concentrated ascites fluid thus produced is returned to the patient by intravenous drip infusion.

[Body fluid storage bag]
Next, the configuration of the body fluid storage bag 1 will be described in detail. Figure 2 is a front view of the body fluid storage bag 1. Figure 3 is a cross-sectional view taken along line III-III with body fluid stored in the body fluid storage bag 1 shown in Figure 2.

In Figure 2, the orientation of the fluid storage bag 1 when suspended from the suspension fitting F is used as a reference, and the direction along the vertical is denoted as the X direction (first direction), and the direction perpendicular to it is denoted as the Y direction (second direction). As shown in the figure, the fluid storage bag 1 has a first inclined edge 24a and a second inclined edge 24b that intersect each other at the bottom in the X direction. The direction along the first inclined edge 24a is denoted as the P direction, and the direction along the second inclined edge 24b is denoted as the Q direction.

As shown in Figure 2, the bodily fluid storage bag 1 comprises a bag body 10, a first suspension part 11, a second suspension part 12, a filter 13, an inlet 14, an injection part 15, and an outlet 16. The bag body 10, as an example, has a long axis A1 and a short axis A2, forming an elongated shape in front view. More specifically, it has a rectangular shape with a pair of short side portions 21u, 21d and a pair of long side portions 22u, 22d. Of these, the short side portions 21u, 21d are aligned in the P direction, and the long side portions 22u, 22d are aligned in the Q direction. Furthermore, the X direction (first direction) in Figure 2 is a direction inclined with respect to either the extension direction of the long axis A1 or the short axis A2 of the bag body 10, and in this embodiment, it substantially coincides with the extension direction of one of the two diagonals. Such a bag body 10 is constructed by closing the edges around the entire circumference of two flexible sheets 10a and 10b made of transparent resin (see Figure 3), and has a storage space 23 of a predetermined capacity for storing bodily fluids inside.

The edge of the bag body 10 that defines the outer edge of the storage space 23 has multiple inclined edges that are inclined with respect to both the vertical direction (X direction) and the horizontal direction (Y direction). These inclined edges include a first inclined edge 24a, a second inclined edge 24b, and a third inclined edge 24c, which are inclined at different angles with respect to the horizontal when the bag body 10 is suspended as shown in Figure 2. Of these, the first inclined edge 24a is located on one side of the vertical line Lv passing through the first suspension part 11 when the bag body 10 is suspended by the first suspension part 11, while the second inclined edge 24b is located on the other side of the vertical line Lv. Furthermore, both the first inclined edge 24a and the second inclined edge 24b are inclined with respect to the vertical line Lv. Furthermore, the first inclined edge portion 24a and the second inclined edge portion 24b are such that at least a portion of the first inclined edge portion 24a is located on one side of the vertical line Lv, and at least a portion of the second inclined edge portion 24b is located on the other side of the vertical line Lv.

More specifically, the short side portion 21d on the lower X-direction of the bag body 10 is provided with a first inclined edge portion 24a extending along the P-direction. This first inclined edge portion 24a is provided with an inlet portion 14, an injection port 15, and an outlet portion 16 (details will be described later). The long side portion 22d on the lower X-direction of the bag body 10 is provided with a second inclined edge portion 24b extending along the Q-direction. Furthermore, at the corner portion C1 where the short side portion 21d and the long side portion 22d intersect, a third inclined edge portion 24c is provided, connecting the first inclined edge portion 24a and the second inclined edge portion 24b and inclining downward toward the connection point of the outlet portion 16. In this way, the first to third inclined edges 24a to 24c are provided on the lower X-direction (the other end in the first direction) of the bag body 10.

Furthermore, the upper short side portion 21u of the bag body 10 in the X direction is provided with a fourth inclined edge portion 24d extending along the P direction, and the upper long side portion 22u in the X direction is provided with a fifth inclined edge portion 24e extending along the Q direction. At the corner portion C2 where the short side portion 21u and the long side portion 22u intersect, a horizontal edge portion 24f is provided that connects the fourth inclined edge portion 24d and the fifth inclined edge portion 24e and extends approximately along the Y direction. In addition, at the corner portion C3 where the upper long side portion 22u and the lower short side portion 21d intersect, a vertical edge portion 24g is provided that connects the first inclined edge portion 24a and the fifth inclined edge portion 24e and extends approximately along the X direction. The outer edge of the storage space 23 is defined by these multiple edges 24a to 24g. Furthermore, the connection points between adjacent edges 24a to 24g have a contour shape that forms an arc outward when viewed from the storage space 23.

A first suspension portion 11 is provided at the upper end of the bag body 10 in the X direction (one end in the first direction) for suspending the bag body 10 from the suspension fitting F. This first suspension portion 11 is provided at the corner portion C2 where the upper short side portion 21u and the long side portion 22u of the bag body 10 intersect. A through hole 11a is formed in this corner portion C2, and an annular fitting such as an eyelet is attached to the through hole 11a. Another second suspension portion 12 is also provided at the other corner portion C3. This second suspension portion 12 has the same configuration as the first suspension portion 11, and a through hole 12a is provided, and an annular fitting such as an eyelet is attached to this through hole 12a. Note that the configuration of the suspension portions 11 and 12 is not limited to the above, and other configurations such as an annular locking device protruding from the bag body 10 can also be adopted.

A filter 13 is provided in the storage space 23 of the bag body 10. The filter 13 divides the storage space 23 into a first chamber 23a and a second chamber 23b (see also Figure 3), and captures and removes predetermined foreign matter (such as aggregates contained in ascites) contained in the body fluid as the stored body fluid moves from the first chamber 23a to the second chamber 23b. The filter 13 is generally trapezoidal in shape when viewed from the front.

More specifically, the filter 13 consists of a mesh-like flexible sheet and has a first side 30a and a second side 30b corresponding to the two legs of a trapezoid, and a third side 30c and a fourth side 30d corresponding to the top and bottom. Of these, the first side 30a follows the first inclined edge 24a, and the second side 30b follows the second inclined edge 24b. The third side 30c follows the third inclined edge 24c and connects the proximal ends of the first side 30a and the second side 30b. The fourth side 30d connects the distal ends of the first side 30a and the second side 30b.

This filter 13 is in the shape of a bag with sides 30a to 30d, which are closed all around. That is, the filter 13 is made of a flexible sheet of a predetermined shape that is folded in half to form the trapezoidal shape described above, with the fold forming the fourth side 30d, the first side 30a fixed to the first inclined edge 24a of the bag body 10, the second side 30b fixed to the second inclined edge 24b, and the third side 30c fixed to the third inclined edge 24c. As a result, the filter 13, which is positioned to be sandwiched inside the bag body 10, has one main surface 13a and the other main surface 13b (see Figure 3) that are not fixed to the bag body 10. In this way, the filter 13, which is shaped like a bag, has at least its first side 30a and second side 30b fixed to the bag body 10, so that the position of the filter 13 can be stably maintained and the main surfaces 13a and 13b of the filter 13 do not stick to the bag body 10. Furthermore, the inner region of the filter 13 surrounded by the first to fourth sides 30a to 30d forms the second chamber 23b of the bag body 10, and the outer region of the filter 13 in the storage space 23 of the bag body 10 forms the first chamber 23a.

As shown in Figure 2, an inlet 14, an injection 15, and an outlet 16 are attached to the first inclined edge 24a in this order. The inlet 14 is a tubular resin member with openings at both ends, and the outer opening forms an inlet 14a. This inlet 14 is provided so as to extend both inside and outside the bag body 10, and connects the first chamber 23a of the bag body 10 with the outside of the bag body 10. Therefore, bodily fluids flow into the first chamber 23a of the bag body 10 through the inlet 14a of the inlet 14. The injection 15 is also a tubular resin member with openings at both ends, and the outer opening forms an injection port 15a. The injection 15 is provided so as to extend both inside and outside the bag body 10 and is located near the inlet 14, and connects the first chamber 23a of the bag body 10 with the outside of the bag body 10. Therefore, drugs and other substances are injected into the first chamber 23a of the bag body 10 through the injection port 15a of the injection unit 15.

The outflow section 16 is a tubular resin member with openings at both ends, the outer opening forming an outlet 16a. This outflow section 16 is provided so as to extend both inside and outside the bag body 10, connecting the second chamber 23b of the bag body 10 with the outside of the bag body 10. Furthermore, the portion of the outflow section 16 located inside the bag body 10 (the portion located inside the second chamber 23b) is enclosed by a filter 13. Therefore, bodily fluids in the second chamber 23b of the bag body 10 are discharged to the outside through the outlet 16a of the outflow section 16. In addition, the outflow section 16 is fixed to the short side portion 21d of the bag body 10, and its end extends along the long side portion 22d of the bag body 10. This allows the length of the outflow section 16 to be increased. The discharged bodily fluids then flow through the CART circuit via line L1, as explained with reference to Figure 1.

The inlet 14, injection 15, and outlet 16 described above are provided so as to intersect (more specifically, perpendicular to) the first inclined edge 24a, and in this embodiment, they are all provided so as to be parallel to the Q direction. Therefore, the openings of the inlet 14, injection 15, and outlet 16 (openings located on the outside of the bag body 10) are directed approximately downward.

Furthermore, while the inlet section 14 and injection section 15 are relatively short, the outlet section 16 is longer than them, having a length of approximately one-third of the longitudinal dimension of the bag body 10. In addition, holes 16b are provided around the periphery of the outlet section 16, which communicate with the passage inside the outlet section 16. Multiple holes 16b are provided at intervals from the other end of the outlet section 16 to the vicinity of the point where the outlet section 16 is fixed to the first inclined edge 24a.

As described above, the mounting position of the outflow section 16 is the first inclined edge 24a. More specifically, the outflow section 16 is mounted on the first inclined edge 24a near the connection point with the third inclined edge 24c. The separation distance D (separation distance along the P direction) between the outflow section 16 and the third inclined edge 24c decreases as it approaches the first inclined edge 24a along the longitudinal direction of the outflow section 16. Thus, the third inclined edge 24c is inclined toward the connection point of the outflow section 16 with respect to the first inclined edge 24a, and the connection point between the first inclined edge 24a and the third inclined edge 24c is the lowest point in the vertical direction of the storage space 23 when the body fluid storage bag 1 is suspended. Furthermore, of the multiple holes 16b in the outflow section 16, the one closest to the connection point to the first inclined edge 24a in the outflow section 16 (hole 16c) is formed to open toward the third inclined edge 24c, as shown in Figure 2.

Furthermore, the filter 13 enclosing the outlet section 16 has an edge corresponding to its fourth side 30d that extends from a predetermined position in the longitudinal direction of the first inclined edge 24a to a predetermined position in the longitudinal direction of the second inclined edge 24b. That is, one end 31 in the longitudinal direction of the fourth side 30d is fixed in the first inclined edge 24a at a position between the inlet section 14 and the outlet section 16, more specifically, between the injection section 15 and the outlet section 16, and at a position close to the injection section 15. The other end 32 in the longitudinal direction of the fourth side 30d is fixed in the second inclined edge 24b at a position closer to the fourth inclined edge 24d than to the first inclined edge 24a. This fourth side 30d extends diagonally upward from one end 31 to the other end 32 in a direction that is inclined with respect to both the first inclined edge 24a and the second inclined edge 24b.

As shown in Figure 2, the bodily fluid storage bag 1 is suspended in a position where both its long axis A1 and short axis A2 are inclined with respect to the X direction (vertical direction). The lower part has a first inclined edge 24a and a second inclined edge 24b, with an outflow section 16 provided on the first inclined edge 24a. Therefore, when processing the bodily fluid in the bodily fluid storage bag 1 with the CART circuit 100, the amount of residual fluid in the bag 1 can be reduced. Furthermore, since the third inclined edge 24c is formed to inclin toward the outflow section 16, the amount of residual bodily fluid can be reduced even further. Moreover, since the hole 16c closest to the first inclined edge 24a in the outflow section 16 opens toward the third inclined edge 24c, the amount of residual bodily fluid can be reduced even more.

Furthermore, the fourth side 30d of the filter 13 is inclined with respect to both the first inclined edge 24a and the second inclined edge 24b. This ensures that even when the amount of bodily fluid remaining in the bodily fluid storage bag 1 decreases, a large effective area of the filter 13 in contact with the remaining bodily fluid can be secured. Therefore, even when the amount of bodily fluid remaining is small, the filter 13 can reliably remove foreign matter. In addition, at least the first side 30a of the filter 13 is fixed to the first inclined edge 24a, and the second side 30b is fixed to the second inclined edge 24b. Therefore, the position of the filter 13 within the bodily fluid storage bag 1 can be stably maintained.

Furthermore, when bodily fluids are stored in the bag body 10 of this bodily fluid storage bag 1, it enters the state shown in Figure 3. That is, the storage space 23 of the bag body 10 expands with the bodily fluids, separating the inner surface of the bag body 10 from the outer surface of the filter 13, preventing them from sticking together. This allows the filter 13 to secure a wide flow range (filter area) for bodily fluids from the first chamber 23a to the second chamber 23b. In addition, the filter 13 expands and contracts as bodily fluids flow into and out of the bag body 10, and a load is placed on the fourth side 30d of the filter 13 at that time. However, since the fourth side 30d is constructed with a folded edge, it has high strength and stable resistance to the load.

The configuration of the bodily fluid storage bag 1 described above is merely a preferred example, and the bodily fluid storage bag 1 according to this disclosure is not limited to such a configuration. For example, the overall shape of the bag body 10 does not have to be rectangular; as long as it has a first inclined edge 24a and a second inclined edge 24b at the bottom when suspended, the top may have a polygonal or arc-shaped contour. The first inclined edge 24a and the second inclined edge 24b are not limited to linear inclinations but may also be curved inclinations. Furthermore, although the bodily fluid storage bag 1 according to this disclosure is rectangular and therefore the first inclined edge 24a and the second inclined edge 24b at the bottom are inclined at different angles relative to the horizontal when suspended, this is not the only possible configuration. For example, the bag body 10 may be square in shape, with the first inclined edge 24a and the second inclined edge 24b inclined at the same angle.

Furthermore, the material and shape of the inlet 14, injection 15, and outlet 16 are not limited to those described above. For example, they may be made of metal instead of resin, and the length, shape, and arrangement of the holes 16b and 16c are not limited to those described above. The outlet 16 extends in a straight line, but it may have a special shape, such as being partially curved. Also, the order of the inlet 14 and injection 15 may be reversed, and in some cases, for example, the inlet 14 and injection 15 may be provided on the fourth inclined edge 24d or the fifth inclined edge 24e. Moreover, the injection 15 is not mandatory.

Furthermore, the configuration of the filter 13 is not limited to those described above. For example, the fourth side 30d may extend from the first inclined edge 24a to the fourth inclined edge 24d. Moreover, the third inclined edge 24c is not essential, and the first inclined edge 24a and the second inclined edge 24b may intersect directly.

[Manufacturing method for body fluid storage bags]
Next, the manufacturing method of the body fluid storage bag 1 described above will be explained. Figure 4 is an exploded perspective view of the body fluid storage bag 1. Figures 5(a) and 5(b) are plan views showing the manufacturing process of the body fluid storage bag. Figures 6(a) and 6(b) are cross-sectional views showing the manufacturing process of the body fluid storage bag.

As shown in Figure 4, the bag body 10 has two rectangular flexible sheets 10a and 10b made of transparent resin, a filter 13 which is a mesh-like flexible sheet that is folded in half to form a trapezoid shape, and an inlet 14, an injection 15, and an outlet 16 made of tubular members. The body fluid storage bag 1 is then constructed by unitizing these components according to the following first to third steps.

First, in the first step, as shown in Figures 5(A) and 6(A), a folded filter 13 is placed between two flexible sheets 10a and 10b. At this time, the two flexible sheets 10a and 10b are positioned so that their long sides and short sides coincide. The filter 13 is positioned so that its first side 30a follows the short sides 21d of the flexible sheets 10a and 10b, and its second side 30b follows the long sides 22d of the flexible sheets 10a and 10b. In order to stably maintain its shape, the folded filter 13 placed between the flexible sheets 10a and 10b may have parts of one or more of its sides (first side 30a, second side 30b, and third side 30c) pre-bonded (for example, welded).

In the second step, as shown in Figures 5(B) and 6(B), the periphery of the flexible sheets 10a and 10b is heat-welded to integrate the flexible sheets 10a and 10b with the filter 13. Specifically, the long sides 22d, short sides 21u, and long side 22u of the flexible sheets 10a and 10b are welded along their respective total lengths, forming linear welding lines 43 in the welded portions. Furthermore, the remaining short side 21d is welded in all but the first portion 41 where the inlet 14 and injection 15 are located, and the second portion 42 where the outlet 16 is located. As a result, the first side 30a of the filter 13 is bonded to the first inclined edge 24a, the second side 30b is bonded to the second inclined edge 24b, and the third side 30c is bonded to the third inclined edge 24c.

Here, in the periphery of the flexible sheets 10a and 10b, the welded portion on the long side 22u has one weld line 43 (single layer), while the other welded portions have two weld lines 43 (double layer). This ensures a large storage space 23 while increasing the adhesive strength of the flexible sheets 10a and 10b. The first side 30a of the filter 13 is located between the two weld lines 43 on the short side 21d, and is therefore fixed by the inner weld line 43. Similarly, the second side 30b and the third side 30c of the filter 13 are each located between the two weld lines 43 and are fixed by the inner weld line 43.

Furthermore, through holes 11a in corner portion C2 and 12a in corner portion C3 are formed between the two welding lines 43. These through holes 11a and 12a for forming the suspension portion may be formed in a step other than this second step. For example, the through holes 11a and 12a may be formed in advance in the flexible sheets 10a and 10b used in the first step, or they may be formed after the next third step is completed.

In the third step, as shown in Figures 5(C) and 6(C), the inlet 14 and injection 15 are placed in the first portion 41 where the flexible sheets 10a and 10b were not welded in the second step, and the outlet 16 is placed in the second portion 42. Then, the first portion 41 and the second portion 42 are heat-welded in this state. Here, the inlet 14 and injection 15 are placed with a gap between them. That is, in the flexible sheets 10a and 10b, the inlet 14 and injection 15 are positioned so that the portion between them has a sufficient contact area with each other, thereby ensuring the welding strength of the flexible sheets 10a and 10b in that portion.

The bodily fluid storage bag 1 according to this embodiment can be manufactured by the procedure described above. This allows for the easy manufacture of a bodily fluid storage bag 1 that has a large effective area for the filter 13 and a small amount of residual bodily fluid.

[Measurements attached to the fluid collection bag]
Incidentally, the main surface of the bodily fluid storage bag 1 according to this embodiment is marked with a scale (storage scale) for measuring the amount of fluid stored when bodily fluid is added from the inlet 14, and a scale (residual scale) for measuring the amount of fluid remaining when bodily fluid is released from the outlet 16.

Figure 7 shows the storage scale 50 attached to one main surface 10A (the outer surface of the flexible sheet 10a) of the bag body 10, and Figure 8 shows the residual scale 60 attached to the other main surface 10B (the outer surface of the flexible sheet 10b) of the bag body 10. The bag body 10 is transparent. Therefore, in Figure 7, the residual scale 60, which is on the back side and visible through the transparent material, is shown in white, and similarly in Figure 8, the storage scale 50, which is on the back side and visible through the transparent material, is shown in white.

The storage scale 50 will now be described. As shown in Figure 7, the storage scale 50 has a scale line 51 and numerical values 52. The scale line 51 is a line segment that extends horizontally when the body fluid storage bag 1 is in the position with the short side 21d, where the inlet 14 is provided, facing upwards (hereinafter referred to as the "collection position"). This scale line 51 has a long, thick line 51a and a short, thin line 51b, and these thick lines 51a and thin lines 51b are arranged alternately in the vertical direction. The numerical values 52 of the storage scale 50 are displayed near the side of the thick line 51a, and in this embodiment, the numerical values increase from bottom to top in increments of 500 mL.

Furthermore, the main surface 10A, which has a storage scale 50, is equipped with an inflow direction indicator (color indicator) 53 that points to the object to be connected to the inflow section 14. This inflow direction indicator 53 is positioned near the inflow section 14 on the bag body 10, and in this embodiment, it is an arrow shape pointing from the inflow section 14 towards the inside of the bag body 10. This inflow direction indicator 53 is colored with a predetermined color, and in this embodiment, it is colored red as an example. In addition, a tape 54 colored with the same color (red) as the inflow direction indicator 53 is attached to the inflow section 14.

Next, the residual scale 60 will be described. As shown in Figure 8, the residual scale 60 has scale lines 61 and numerical values 64. The scale line 61 has a first scale line 62, which is a horizontally extending line segment when the body fluid storage bag 1 is in a position with the short side 21d on which the outflow section 16 is provided facing downwards (hereinafter referred to as the "discharge position"), and a second scale line 63 that is inclined with respect to the first scale line 62.

To explain in more detail, this bodily fluid storage bag 1 is intended to be used in two different suspension positions, a first suspension position and a second suspension position, where the outflow section 16 is facing downwards during discharge. The first suspension position is, for example, the position when the short side 21u is held horizontally by grasping the corner portions C2 and C4 at both ends with the left and right hands (see Figure 9). The second suspension position is the position when the suspension portion 11 of the corner portion C2 is suspended by a hook F or the like (see Figure 10). The first scale line 62 is provided to measure the residual amount in the first suspension position, and the second scale line 63 is provided to measure the residual amount in the second suspension position.

Therefore, multiple first scale lines 62 are provided as line segments perpendicular to the vertical direction when the bag body 10 is suspended in the first suspension position (in other words, horizontal line segments in the first suspension position). Similarly, multiple second scale lines 63 are provided as line segments perpendicular to the vertical direction when the bag body 10 is suspended in the second suspension position (in other words, horizontal line segments in the second suspension position). In this embodiment, these first scale lines 62 and second scale lines 63 form pairs that indicate the same residual amount, and the proximal ends of the paired first scale lines 62 and second scale lines 63 are connected to each other. Consequently, the paired first scale lines 62 and second scale lines 63 have a shape in which the line segment is bent midway, and multiple such pairs are arranged in the vertical direction.

Furthermore, the length LE1 of the first scale line 62 decreases as you move from one end (short side 21u) to the other end (short side 21d). Conversely, the length LE2 of the second scale line 63 increases as you move from one end to the other. The scale line 61 has a long, thick line 61a and a short, thin line 61b, and these thick and thin lines 61a and 61b are arranged alternately in the vertical direction. The numerical value 64 of the residual scale 60 is displayed near the side of the second scale line 63 that constitutes the thick line 61a, and in this embodiment, the numerical value increases from bottom to top every 500 mL.

Furthermore, the main surface 10B, which has a residual scale 60, is equipped with an outflow direction indicator (color indicator) 65 that points to an object to be connected to the outflow section 16. This outflow direction indicator 65 is positioned near the outflow section 16 on the bag body 10, and in this embodiment, it is an arrow shape pointing from the inside of the bag body 10 through the outflow section 16 to the outside. This outflow direction indicator 65 is colored with a predetermined color (different from the inflow direction indicator 53), and in this embodiment, it is colored blue as an example. In addition, a tape 66 colored with the same color (blue) as the outflow direction indicator 65 is attached to the outflow section 16.

Furthermore, a horizontally elongated rectangular frame 67 is marked on the upper part of the main surface 10B where the residual scale 60 is located in the discharge position (Figures 9 and 10). This frame 67 indicates the position where a sticker for writing the name of the patient from whom the body fluid was collected will be affixed to the body fluid collection bag 1.

When using such a body fluid storage bag 1 connected to a CART circuit, it is supported in the first suspension position as shown in Figure 9 when the residual amount is relatively large, and in the second suspension position as shown in Figure 10 when the residual amount decreases. Furthermore, since the body fluid storage bag 1 has a first scale line 62 and a second scale line 63 corresponding to either position, the residual amount of body fluid can be accurately grasped regardless of the position in which it is used, making it easy to use.

Furthermore, the first scale line 62 corresponding to the first suspension position is longer at the top, and the second scale line 63 corresponding to the second suspension position is longer at the bottom. Therefore, when the residual amount is large, supporting it in the first suspension position makes it easier to compare the first scale line 62 with the fluid level S1 of the body fluid (Figure 9), and when the residual amount is small, supporting it in the second suspension position makes it easier to compare the second scale line 63 with the fluid level S2 of the body fluid (Figure 10), enabling a more accurate determination of the residual amount.

Furthermore, the fluid storage bag 1 has a storage scale 50, an inflow direction indicator 53, and a tape 54 that are linked to each other by either their display surface or color, and the residual scale 60, an outflow direction indicator 65, and a tape 66 are also linked to each other by either their display surface or color. Therefore, when using the fluid storage bag 1 (when collecting fluids and when draining fluids), it is easy to distinguish and understand the top and bottom orientation of the fluid storage bag 1 and the target tube to be connected.

The above-described configuration is merely an example, and any configuration can be modified as appropriate within the scope of the present invention. For example, the first scale line 62 and the second scale line 63 may be reversed from the arrangement shown in the figure, or they may be separated and not connected to each other. The inflow direction indicator 53 and the outflow direction indicator 65 are not limited to arrow shapes, but may also be represented by triangular shapes or characters. The tapes 54 and 66 attached to the inflow section 14 and the outflow section 16 may be replaced with other colored parts, or the inflow section 14 and the outflow section 16 may be directly colored without any attachments. Furthermore, in the residual scale 60, the lengths LE1 and LE2 of the first scale line 62 and the second scale line 63 may be kept constant.

(Embodiment 2)
First, as an example of a body cavity fluid processing circuit for processing body cavity fluid collected using the body cavity fluid collection device according to the present invention, a CART circuit will be described.

[CART circuit]
Figure 11 is a schematic diagram of a CART circuit for processing ascites, which is body fluid collected by a body fluid collection device according to Embodiment 2 of the present disclosure. As shown in Figure 11, the CART circuit 1010 consists of a flexible tube through which ascites flows from the body fluid storage bag 1001 through the filter 1002 and the concentrator 1003 to the recovery bag 1004. Specifically, a line L1 for ascites extends from the body fluid storage bag 1001, which is suspended from a hanging fitting F provided at the tip of a stand, etc., through the first pump P1 to the bottom of the filter 1002. Partway along this line L1, between the body fluid storage bag 1001 and the first pump P1, a line extending from a bag 1005 containing physiological saline joins it. Furthermore, partway along line L1, between the first pump P1 and the filter 1002, a line extending from a pressure gauge 1006, which measures the pressure of the ascites fluid flowing through line L1, joins the line.

From the side of the filter 1002, line L2, through which ascites fluid from which foreign matter has been removed by the filter 1002 flows, extends to the bottom of the concentrator 1003 via the second pump P2. From the top of the concentrator 1003, line L3, through which ascites fluid that has been dewatered and concentrated by the concentrator 1003 flows, extends to the inlet port of the recovery bag 1004. Furthermore, from the outlet port of the recovery bag 1004, line L4 extends to circulate the concentrated ascites fluid in order to further concentrate it, and this line L4 merges with line L2 between the filter 1002 and the second pump P2.

Meanwhile, a line L5 extends from the top of the filter 1002 to appropriately discharge foreign matter removed from the ascites fluid by the filter 1002. Furthermore, a line L6 extends from the side of the concentrator 1003 to appropriately discharge water removed from the ascites fluid by the concentrator 1003.

In this CART circuit 1010, the ascites fluid collected from the patient and stored in the body fluid storage bag 1001 is filtered to remove unwanted components by the filter 1002 and concentrated to an appropriate concentration by the concentrate 1003, becoming filtered and concentrated ascites fluid which is then collected in the recovery bag 1004. The filtered and concentrated ascites fluid thus produced is then returned to the patient by intravenous drip infusion.

[Body cavity fluid collection device]
Next, a body fluid collection device for collecting body fluid from a patient to be processed by the CART circuit 1010 as described above will be explained. Figure 12 is a schematic diagram showing the collection process. As shown in Figure 12, the body fluid collection device 1030 has a collection tube 1031, a drip chamber 1032, an air introduction tube 1033, and a delivery tube 1034. This body fluid collection device 1030 is interposed between the patient 1020 and the storage bag 1001, and guides the body fluid from the patient's abdominal or thoracic cavity to the storage bag 1001.

More specifically, one end 1021a of the catheter 1021 is placed in the patient's abdominal or thoracic cavity. The other end 1021b of the catheter 1021 is connected to the upstream end 1031a of the collection tube 1031 via a connector 1040. The downstream end 1031b of the collection tube 1031 is connected to a drip chamber 1032, and the upstream end 1034a of the delivery tube 1034 is also connected to the drip chamber 1032. Furthermore, the downstream end 1034b of the delivery tube 1034 is connected to the inlet tube 1012 of the storage bag 1001 via a connector 1041. As a result, the patient's body fluid is guided to the storage bag 1001 through the catheter 1021 and the body fluid collection device 1030. Note that the catheter 1021 may be a resin needle or a metal needle.

The storage bag 1001 comprises a transparent and flexible bag body 1011, and an inlet pipe 1012, an injection pipe 1013, and an outlet pipe 1014 that connect the inside and outside of the bag body 1011. The inlet pipe 1012 is a port that guides body fluid into the bag body 1011 when body fluid is collected, the injection pipe 1013 is a port for injecting a drug solution into the body fluid collected in the bag body 1011, and the outlet pipe 1014 is a port that drains body fluid from the bag body 1011 during CART processing. Typically, the body fluid storage bag 1 according to Embodiment 1 can be used as such a storage bag 1001.

Next, the body fluid collection device 1030 will be described in more detail. Figure 13 is a diagram showing the body fluid collection device 1030, and Figure 14 is an enlarged cross-sectional view showing a part of the body fluid collection device 1030 in Figure 13. As shown in Figure 13, the collection tube 1031 is a long tubular shape and is made of a transparent and flexible synthetic resin. A connector 1040 is attached to the upstream end 1031a of the collection tube 1031, making it connectable to the end 1021b of the catheter 1021. A roller clamp 1042 is attached to the middle of the collection tube 1031 as a flow rate regulator for the body fluid. Note that other clamps besides the roller clamp 1042 may be attached as flow rate regulators.

The drip chamber 1032 is generally cylindrical in shape and includes a cylindrical body 1050, an upstream cap 1051 that closes one end of the cylindrical body 1050, and a downstream cap 1052 that closes the other end of the cylindrical body 1050. Of these, the cylindrical body 1050 is made of a relatively hard, transparent synthetic resin and is constructed in a cylindrical shape.

As shown in Figure 14, the upstream cap 1051 is generally cylindrical, and a first connection part 1060 and a second connection part 1061 are provided at one end in the axial direction (the upstream side in the direction of body fluid collection). The collection tube 1031 is connected to the first connection part 1060. For this purpose, the first connection part 1060 is cylindrical in shape with an inner diameter approximately the same as the outer diameter of the collection tube 1031. The opening of the first connection part 1060 forms an inlet 1062 to which the downstream end 1031b of the collection tube 1031 is connected. The opening end of the inlet 1062 on the cylindrical body 1050 side forms an opening surface 1062a that is inclined with respect to the axial direction of the inlet 1062.

The air introduction tube 1033 is connected to the second connection part 1061. For this purpose, the second connection part 1061 is cylindrical in shape, having an inner diameter approximately the same as the outer diameter of the air introduction tube 1033. The opening of the second connection part 1061 forms an air inlet 1063 to which the downstream end 1033b of the air introduction tube 1033 is connected. The opening end of the air inlet 1063 on the cylindrical body 1050 side forms an opening surface 1063a that is approximately perpendicular to the axial direction of the air inlet 1063.

The other end of the upstream cap 1051 in the axial direction forms an external fitting portion 1065 that fits onto one end of the cylindrical body 1050. That is, the internal diameter of the external fitting portion 1065 is approximately the same as the external diameter of one end of the cylindrical body 1050, and the two are connected by fitting onto one end of the cylindrical body 1050.

The downstream cap 1052, which closes the other end of the cylindrical body 1050, has a weight-like cylindrical shape, with the diameter of the other end being smaller than the diameter of the one end. The one end of the downstream cap 1052 forms an outer fitting portion 1066 that fits onto the other end of the cylindrical body 1050. In other words, the inner diameter of the outer fitting portion 1066 is approximately the same as the outer diameter of the other end of the cylindrical body 1050, and the two are connected by fitting onto the other end of the cylindrical body 1050.

A third connecting portion 1067 is provided at the other end of the downstream cap 1052. The discharge tube 1034 is connected to this third connecting portion 1067. For this purpose, the third connecting portion 1067 is cylindrical in shape, having an inner diameter approximately the same as the outer diameter of the discharge tube 1034. The opening of the third connecting portion 1067 forms an outlet 1068 to which the upstream end 1034a of the discharge tube 1034 is connected. In the downstream cap 1052, the portion between the outer fitting portion 1066 at one end and the third connecting portion 1067 at the other end forms a reduced diameter portion 1069 in which both the outer and inner diameters are gradually reduced. Furthermore, when the upstream cap 1051 is fitted to one end of the cylindrical body 1050 and the downstream cap 1052 is fitted to the other end as described above, the internal space forms a storage space 1050a in the drip chamber 1032 where body fluid is temporarily stored.

On the other hand, the air introduction tube 1033, whose downstream end 1033b is connected to the second connection part 1061 of the upstream cap 1051, is a long tubular shape and is made of a transparent and flexible synthetic resin. A connector 1043 is provided at the upstream end 1033a of this air introduction tube 1033, and it can be connected to an air syringe or air pump via the connector 1043. In addition, a tube clamp 1044, which is an opening and closing device, is attached to the middle of the air introduction tube 1033 as an air flow rate adjustment device. Note that other clamps besides the tube clamp 1044 may also be attached as a flow rate adjustment device.

[How to use body cavity fluid sampling device]
The method of using the body fluid collection device described above will now be explained. First, the delivery tube 1034 of the body fluid collection device 1030 is connected to the inlet tube 1012 of the empty storage bag 1001 via the connector 1041. Next, with the roller clamp 1042 and tube clamp 1044 closed, the collection tube 1031 of the body fluid collection device 1030 is connected to the end 1021b of the catheter 1021 extending from the patient's abdominal or thoracic cavity via the connector 1040. Then, the body fluid collection device 1030 and storage bag 1001 are placed vertically below the patient. In this state, the collection of body fluid is started by adjusting the opening of the collection tube 1031 by operating the roller of the roller clamp 1042.

During the collection of body fluid, the collection pace and the timing of completion of the collection process are determined based on the body fluid dripping into the storage space 1050a of the drip chamber 1032 via the collection tube 1031. However, during the collection of body fluid, the storage space 1050a of the drip chamber 1032 may become filled with body fluid if the patient changes position or if the body fluid collection device 1030 or the storage bag 1 shifts position. In such cases, it becomes difficult to determine the collection pace and the timing of completion.

Therefore, in the body fluid collection device 1030 according to this embodiment, if the storage space 1050a is filled with body fluid, the tube clamp 1044 is opened and air is introduced into the drip chamber 1032 via the air introduction tube 1033. Air can be introduced, for example, by a syringe or air pump connected to the upstream end 1033a of the air introduction tube 1033. By introducing an appropriate amount of air into the drip chamber 1032 in this way, the liquid level of body fluid in the storage space 1050a can be lowered, and the dripping status of body fluid from the collection tube 1031 can be visually confirmed again. As a result, the collection pace and completion timing can be grasped.

In the above explanation, an example was described in which a clamp such as a tube clamp 1044 is provided in the middle of the air introduction tube 1033. However, instead of a clamp, a known hydrophobic filter may be provided at the upstream end 1033a of the air introduction tube 1033. Alternatively, the clamp and hydrophobic filter may be installed together with the air introduction tube 1033. By doing so, even if the clamp is forgotten to be closed (or not unintentionally closed completely), leakage of body cavity fluid through the air introduction tube 1033 can be prevented.

(Embodiment 3)
Figure 15 is a diagram showing other components of the body fluid collection device. This body fluid collection device 1030A differs from the body fluid collection device 1030 of Embodiment 2 in that the air introduction tube 1033 is connected to the middle of the collection tube 1031, rather than to the drip chamber 1032. On the other hand, the other components are substantially the same. Therefore, the differences will be explained in detail below, and components common to both embodiments will be denoted by the same reference numerals, and detailed explanations thereof will be omitted.

As shown in Figure 15, the drip chamber 1032A of this body fluid collection device 1030A has an upstream cap 1051A that only has a first connection part 1060 and does not have a second connection part 1061 as in Embodiment 2. Therefore, only the collection tube 1031A is connected to the upstream cap 1051A. Of course, there is no restriction on using an upstream cap 1051 with the second connection part 1061 closed in place of the upstream cap 1051A in the drip chamber 1032A.

On the other hand, the sampling tube 1031A has an upstream tube 1311 and a downstream tube 1312, and the two tubes 1311 and 1312 are connected by a three-way branch joint 1313. That is, for example, of the three joint sections 1313a to 1313c of the T-shaped three-way branch joint 1313, the downstream end of the upstream tube 1311 and the upstream end of the downstream tube 1312 are connected to the two linearly aligned joint sections 1313a and 1313b, respectively. The roller clamp 1042 is provided in the middle of the upstream tube 1311.

The downstream end 1033b of the air introduction tube 1033 is connected to the remaining joint portion 1313c of the three-way branch joint 1313. A tube clamp 1044 is provided in the middle of this air introduction tube 1033, similar to Embodiment 2. In other words, in the body fluid collection device 1030A according to this embodiment, the air introduced from the air introduction tube 1033 is sent to the storage space 1050a of the drip chamber 1032A through the collection tube 1031A (downstream tube 1312). Therefore, an air inlet is provided in the middle of the collection tube 1031A. Note that the tube clamp 1044 may be replaced with another clamp, and a hydrophobic filter may be provided instead of the clamp, or together with the clamp, as in Embodiment 2.

The method of use for the body fluid collection device 1030A according to this third embodiment is the same as that described for the second embodiment. Therefore, if the patient changes position or the body fluid collection device 1030 or the storage bag 1001 shifts position and the storage space 1050a becomes filled with body fluid, the fluid level of the body fluid in the storage space 1050a can be lowered by introducing air into the drip chamber 1032A via the air introduction tube 1033, and the dripping status of the body fluid from the collection tube 1031A can be visually confirmed again. As a result, the collection pace and completion timing can be grasped.

The present invention can be suitably applied to fluid storage bags for storing ascites in CART circuits and other bodily fluids. Furthermore, the present invention can be suitably applied to fluid collection devices used to collect fluid from the abdominal or pleural cavity of a patient.

1 Body fluid storage bag 10 Bag body 11 Hanging part 13 Filter 14 Inlet 16 Outlet 23 Storage space 23a First chamber 23b Second chamber 24a First inclined edge 24b Second inclined edge 24c Third inclined edge 100 CART circuit A1 Long axis A2 Short axis 1030, 1030A Body fluid collection device 1031, 1031A Collection tube 1032, 1032A Drip chamber 1033 Air introduction tube 1034 Delivery tube 1043 Connector 1044 Tube clamp (opening/closing device)
1062 Inlet 1063 Air inlet 1068 Outlet

Claims (11)

The bag body is made of a flexible sheet and stores bodily fluids inside,
A suspension part is provided at one end of the bag body in order to suspend the bag body,
The bag body is divided into a first chamber and a second chamber, and a filter is provided to remove foreign matter from bodily fluids moving from the first chamber to the second chamber.
An outlet extending into the interior of the second chamber, through which bodily fluids from the bag body flow out,
Equipped with,
The bag body has a first inclined edge and a second inclined edge at the other end, which are inclined with respect to the vertical line that divides the bag body when it is suspended, and at least a portion of the outflow section in the second chamber extends in a direction intersecting the direction along the vertical direction when the bag body is suspended.
Furthermore, the outflow section is provided on the first inclined edge, and the bag body further has a third inclined edge that intersects with the vertical line, connects the first inclined edge and the second inclined edge, and inclined toward the connection point of the outflow section.
Body fluid collection bag. The outflow section is provided on the first inclined edge such that the outlet faces downward.
The fluid storage bag according to claim 1. The edge of the filter extends in a direction that is inclined with respect to both the first inclined edge and the second inclined edge.
The fluid storage bag according to claim 1 . The edges of the filter extend in a direction that intersects with and is not perpendicular to the direction along the vertical direction when the bag body is suspended.
The fluid storage bag according to claim 3 . The bag further comprises an inlet that communicates with the first chamber and through which bodily fluids flow into the bag body,
The inlet and outlet portions are provided on the first inclined edge, and the edge of the filter extends from between the connection point of the inlet portion and the connection point of the outlet portion on the first inclined edge.
The fluid storage bag according to claim 3 or 4 . The filter is in the shape of a bag that encloses the portion of the outflow section located in the second chamber, and is fixed to the bag body at least at the first inclined edge and the second inclined edge.
The fluid storage bag according to claim 1 . The aforementioned flexible sheet is transparent ,
The main surface of the bag body is marked with a residual scale that indicates the amount of bodily fluid remaining in the bag body when the bodily fluid is discharged from the outlet.
The residual scale has a plurality of first scale lines perpendicular to the vertical direction when the bag body is suspended in a first suspension position with the outflow section facing downwards, and a plurality of second scale lines perpendicular to the vertical direction when the bag body is suspended in a second suspension position different from the first suspension position with the outflow section facing downwards.
The fluid storage bag according to claim 1 . The multiple first scale lines have a length that decreases from one end to the other, and the multiple second scale lines have a length that increases from one end to the other.
The fluid storage bag according to claim 7 . The plurality of first and second grid lines include a pair of first and second grid lines that indicate the same residual amount to each other, and the proximal ends of the pair of first and second grid lines are connected to each other.
The fluid storage bag according to claim 7 or 8 . The aforementioned flexible sheet is transparent ,
The bag body is further provided with an inlet connected to the other end, communicating with the first chamber, through which bodily fluids flow into the bag body,
One main surface of the bag body is provided with a storage scale indicating the amount of bodily fluid stored in the bag body when bodily fluid is introduced from the inlet, and an inflow direction indicator indicating the direction of bodily fluid inflow from the inlet.
The other main surface of the bag body is provided with a residual scale indicating the amount of bodily fluid remaining in the bag body when bodily fluid is discharged from the discharge opening, and a discharge direction indicator indicating the direction of discharge of bodily fluid from the discharge opening.
The fluid storage bag according to claim 1 . The aforementioned flexible sheet is transparent ,
The bag body is further provided with an inlet connected to the other end, communicating with the first chamber, through which bodily fluids flow into the bag body,
The main surface of the bag body is provided with color indicators that point to the objects to be connected to the inlet and outlet.
The fluid storage bag according to claim 1 .