Liquid Delivery Device

Abstract

To provide a fluid feeding device capable of adjusting an inflow speed of fluid into a retained luminal organ.SOLUTION: A fluid feeding device 1 which communicates luminal organs 2 and feeds body fluid from one side to the other side retained in the luminal organs 2: a cylindrical body part 10 having a body fluid inflow part on one side; a first valve part 13 provided on the other side of the body part 10 that opens and closes by elastic deformation; and a second valve part 14 that covers the first valve part 13 from outside, and opens and closes by elastic deformation. The first valve part 13 opens and causes body fluid to flow when the pressure of the body fluid on one side is a predetermined level or higher. The second valve part 14 opens when the pressure higher than the opening pressure of the first valve part 13 is received from one side, and causes the body fluid passing through the first valve part 13 to flow into the luminal organs 2.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a liquid delivery device. [Background technology]

[0002] BACKGROUND ART Conventionally, a procedure has been known in which an endoscopic ultrasound (EUS) is used transorally to examine and treat tumors in the esophagus, stomach, duodenum, large intestine, pancreas, biliary tract, gallbladder, etc., as well as surrounding lymph nodes and blood vessels.

[0003] Furthermore, Patent Document 1 discloses a stent that can prevent backflow and allow bodily fluids to flow in one direction into a hollow organ as a stent used in drainage procedures performed under an ultrasonic endoscope. The stent in Patent Document 1 has a main body that penetrates the inner wall of the hollow organ and is placed in the hollow organ, and a valve that prevents backflow of bodily fluids in the main body. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2021 / 044837 Summary of the Invention [Problem to be solved by the invention]

[0005] The stent of Patent Document 1 can prevent backflow of bodily fluids through the stent by using the valve portion, but it is difficult to adjust the inflow rate of bodily fluids into the luminal organ in which it is placed.

[0006] The present invention has been made in view of the above problems, and aims to provide a fluid delivery device that can adjust the inflow rate of bodily fluid into an indwelling hollow organ. [Means for solving the problem]

[0007] One aspect of the present invention is a fluid delivery device that connects hollow organs and allows bodily fluid to flow from one side to another side placed inside the hollow organ. The fluid delivery device includes a cylindrical main body having an inlet for bodily fluid on one side, a first valve provided on the other side of the main body and opening and closing by elastic deformation, and a second valve covering the first valve from the outside and opening and closing by elastic deformation. The first valve opens to allow the bodily fluid to flow when the pressure of the bodily fluid on one side is equal to or higher than a predetermined value. The second valve opens when it receives pressure from one side that is higher than the opening pressure of the first valve, allowing the bodily fluid that has passed through the first valve to flow into the hollow organ. [Effects of the Invention]

[0008] According to the present invention, it is possible to provide a fluid delivery device that can adjust the inflow rate of body fluid into an indwelling hollow organ. [Brief explanation of the drawings]

[0009] [Figure 1] 1A and 1B are diagrams illustrating a configuration example of a liquid delivery device according to an embodiment of the present invention. [Figure 2] FIG. 10 is a schematic diagram showing an example of an indwelling state of the liquid delivery device. [Figure 3] FIG. 10 is a view partially showing the other side of the liquid delivery device in an indwelling state. [Figure 4] FIG. 10 is a view showing the valve portion on the other side of the liquid delivery device. [Figure 5] FIG. 2 is a diagram showing a cross section of a main body of the liquid delivery device. [Figure 6] FIG. 10(a) is a schematic diagram showing another example of the indwelling state of the liquid-delivery device, and FIG. 10(b) is a diagram partially showing the other side of the liquid-delivery device in the another example of the indwelling state. DETAILED DESCRIPTION OF THE INVENTION

[0010] Hereinafter, a configuration example of a fluid-delivery device according to an embodiment of the present invention will be described with reference to the drawings. In this embodiment, as an example of a fluid-delivery device, a fluid-delivery device that returns body fluid stored in the abdominal cavity to abdominal organs will be described.

[0011] Here, the shapes, dimensions, etc. of each part in the drawings are shown schematically and do not represent the actual shapes, dimensions, etc. In the drawings, the axial direction Ax of the liquid-delivery device is indicated by an arrow as needed. Also, the direction approximately perpendicular to the axial direction Ax is defined as the radial direction. Furthermore, as needed, one side of the liquid-delivery device is indicated by the symbol B in the drawings, and the other side is indicated by the symbol F.

[0012] FIG. 1 is a diagram showing an example of the configuration of the liquid-delivery device 1. FIG. 2 is a schematic diagram showing an example of the liquid-delivery device 1 in an indwelling state. FIG. 3 is a diagram partially showing the other side of the liquid-delivery device in an indwelling state. FIG. 4 is a diagram showing the valve section on the other side of the liquid-delivery device. FIG. 5 is a diagram showing a cross section (a cross section on a plane perpendicular to the axial direction) of the main body section 10 of the liquid-delivery device 1.

[0013] The fluid-delivery device 1 is a device having an overall cylindrical shape. The fluid-delivery device 1 is used to return ascites (body fluid) that has accumulated in excess in the abdominal cavity and contains useful components such as white blood cells and proteins to an abdominal organ 2 (e.g., the stomach). As shown in Figures 2 and 3, the fluid-delivery device 1 is inserted into and left in an opening 2b formed in a wall 2a of the abdominal organ 2. One side of the fluid-delivery device 1 is located upstream in the direction of body fluid flow and is disposed within the abdominal cavity 3. The other side of the fluid-delivery device 1 is located downstream in the direction of body fluid flow and is disposed within the abdominal organ 2. The abdominal cavity organs 2 include, for example, digestive organs and digestive tracts such as the stomach, duodenum, small intestine, and large intestine, but are not limited to these examples.

[0014] As shown in Fig. 1, the fluid-delivery device 1 includes a cylindrical main body 10, one side of which communicates with the other side in the axial direction Ax, a first locking portion 20, and a second locking portion 30. In the indwelling state shown in Figs. 2 and 3, the internal space of the main body 10 forms a flow path through which bodily fluid can pass from one side to the other. The dimensions of the main body 10 in the axial direction Ax and the radial direction are determined appropriately within a range in which bodily fluid stored in the abdominal cavity 3 can be guided into the abdominal organs 2 without placing more strain than necessary on the patient's body.

[0015] The main body 10 has a cylindrical skeleton 11 and a coating 12 fixed to the skeleton 11. The main body 10 also has a first valve 13 and a second valve 14 on the other side in the axial direction Ax, and is open at one end in the axial direction Ax. One side surface of the main body 10 is provided with a plurality of auxiliary inflow holes 15a penetrating the coating 12 from the inside to the outside to assist the inflow of body fluids into the main body 10. As a result, body fluids flow into the main body 10 through the openings 15 on one side and the auxiliary inflow holes 15a. Note that the auxiliary inflow holes 15a do not necessarily have to be provided in the main body 10.

[0016] The skeleton portion 11 in this embodiment is disposed on the main body portion 10 excluding the tip portion of the first valve portion 13 (flat portion 13b described later). The skeleton 11 has a so-called self-expanding configuration in which the shape of the expanded state is memorized, and is expandable and contractible from a contracted state in which it contracts radially inward to an expanded state in which it expands radially outward. Although not shown, the fluid delivery device 1 is housed in a sheath in a radially inward contracted state (not shown) and introduced into the patient's body via an ultrasound endoscope (EUS: Endoscopic Ultrasonography).

[0017] As an example, the skeleton 11 is formed by weaving wires made of metal wires into a fence shape. Examples of materials for the wires of the skeleton 11 include known metals or metal alloys, such as Ni-Ti alloys, stainless steel, and titanium alloys. The skeleton 11 may also be formed from materials other than metals (such as ceramics and resins).

[0018] Furthermore, an alloy material having X-ray contrast may be used for the wire material of the skeleton 11, or a marker piece (not shown) made of an alloy material having X-ray contrast may be attached to the wire material as appropriate. In these cases, the position of the liquid delivery device 1 can be confirmed from outside the body.

[0019] When a Ni-Ti alloy is used as the material for constructing the skeletal portion 11, the skeletal portion 11 can be made to memorize the expanded state shape by adjusting the skeletal portion 11 to its expanded state shape and then subjecting it to a predetermined heat treatment.

[0020] The structure of the skeleton 11 is not limited to the above. For example, the skeleton 11 may be formed by weaving metal wires in a lattice or spiral pattern using another weaving method. Alternatively, a thin-walled cylinder made of any of the above metals may be laser-cut to form the skeleton 11 in a pattern in which thin metal wires are wound spirally while being folded back in a zigzag pattern.

[0021] The coating portion 12 is a cylindrical flexible membrane that forms the above-mentioned flow path, and is attached to the skeleton portion 11 so as to close gaps in the skeleton portion 11. In this embodiment, as shown in Fig. 5, the coating portion 12 is attached to the outer periphery of the skeleton portion 11. The coating portion 12 may be fixed to the skeleton portion 11 by any method, such as forming a coating by dipping, sewing with thread, bonding, welding, or adhering with tape.

[0022] The coating 12 is formed of an acid-resistant and biocompatible material because it is used in an environment where it is exposed to the digestive fluids (e.g., gastric juice) of the abdominal organs 2. Examples of materials for the coating 12 include fluororesins such as PTFE (polytetrafluoroethylene) and polyethylene resins such as ultra-high molecular weight polyethylene. Ultra-high molecular weight polyethylene is polyethylene with a molecular weight of 1 to 7 million. In addition, when the pH value is high depending on the type or state of the abdominal organ 2 to be placed, or when the placement period is relatively short, the coating portion 12 does not necessarily need to be acid-resistant.

[0023] In the fluid delivery device 1, the main body 10 is continuously covered with the membrane of the coating part 12. As a result, the flow path is integrally formed with the acid-resistant and biocompatible membrane at the part that faces the opening 2b in the wall 2a of the abdominal organ 2 when placed and passes through the wall 2a of the abdominal organ 2 (for example, the area between the first engaging part 20 and the second engaging part 30), and at the part disposed inside the abdominal organ 2 on the downstream side thereof (the area from the first engaging part 20 to the first valve part 13).

[0024] The coating portion 12 may have different physical properties for each part of the fluid-delivery device 1. For example, an acid-resistant membrane may be provided at the part passing through the wall 2a of the abdominal organ 2 and at a part downstream of the part (the part disposed within the abdominal organ 2), and an acid-resistant membrane may be provided at other parts.

[0025] Both the first valve portion 13 and the second valve portion 14 are check valves, and function to allow bodily fluids to flow from one side to the other and to prevent backflow of bodily fluids from the other side.

[0026] The first valve portion 13 is provided on the other side of the main body portion 10 and is formed in a tapered shape such that the cross-sectional area of ​​the flow path on one side is smaller than the cross-sectional area of ​​the flow path on the other side. The first valve portion 13 has, from one side to the other, a tapered portion 13a and an elastically deformable flat portion 13b. An outlet port 13c is formed on the other side of the flat portion 13b.

[0027] The tapered portion 13a is formed in a shape in which the dimension in a first direction D1 perpendicular to the axial direction Ax is substantially constant and the dimension in a second direction D2 substantially perpendicular to the axial direction Ax and the first direction D1 becomes narrower from one side to the other. In other words, in the tapered portion 13a, the flow path cross-sectional area gradually decreases from one side to the other. The first direction D1 and the second direction D2 are shown in FIG. 4.

[0028] Furthermore, a pair of extensions 11a, 11a extending toward the outlet 13c are arranged in the tapered portion 13a of the first valve portion 13. The pair of extensions 11a, 11a are made of part of the metal wires that make up the skeleton portion 11 and are arranged to face each other across the tube axis of the main body portion 10, with the height of the two ridges that face each other in the radial direction of the main body portion 10 being higher than the height of the other ridges.

[0029] The flat portion 13b is an openable / closable portion formed in a flat shape in which the dimensions in the first direction D1 and the second direction D2 are maintained along the axial direction Ax and the membrane body is substantially tightly attached in the second direction D2. An outlet 13c is formed on the other side of the flat portion 13b to allow body fluid to flow into the abdominal organ 2. The dimension of the flat portion 13b in the first direction D1 may vary, for example, along the axial direction Ax.

[0030] When the internal pressure of the bodily fluid on one side of the first valve part 13 is less than a predetermined value, the flat part 13b extends linearly in the first direction D1 and the membrane body adheres tightly to the flat part 13b in the second direction D2. As a result, when the internal pressure of the bodily fluid on one side of the first valve part 13 is less than a predetermined value, the flat part 13b keeps the outlet 13c closed, making it difficult for the bodily fluid to flow.

[0031] On the other hand, when the internal pressure of the body fluid flowing into first valve portion 13 from one side reaches a predetermined level or higher, flat portion 13b is pushed open by the internal pressure of the body fluid and moves away in second direction D2. As a result, when the internal pressure of the body fluid on one side of first valve portion 13 reaches a predetermined level or higher, flat portion 13b opens outlet 13c, allowing the body fluid to flow to the other side.

[0032] As described above, the first valve section 13 allows the body fluid to be discharged from the outflow port 13c into the abdominal organ 2 when the outflow port 13c is open, while it prevents the body fluid including digestive fluid from flowing back from the abdominal organ 2 through the outflow port 13c into the fluid delivery device 1 when the outflow port 13c is closed. Note that the outflow port 13c opens into, for example, an elliptical or rectangular shape when discharging the body fluid, but the opening shape of the outflow port 13c is not particularly limited as long as it is a shape that allows the body fluid to pass through.

[0033] The first valve portion 13 is formed of a biocompatible and elastically deformable thin film material. Examples of materials for the first valve portion 13 include silicone resin, fluororesin such as PTFE, and polyethylene resin such as ultra-high molecular weight polyethylene. Note that, because the second valve portion 14 prevents the first valve portion 13 from coming into direct contact with digestive fluids, the first valve portion 13 can be made of a material with physical properties suitable for a check valve, such as silicone resin, regardless of acid resistance.

[0034] When the first valve portion 13 is made of silicone resin, the first valve portion 13 can be formed on the other side of the main body portion 10 by dipping. The first valve portion 13 may also be formed integrally with the main body portion 10 by the membrane of the coating portion 12.

[0035] The second valve portion 14 is attached to the outside of the first valve portion 13 and covers the first valve portion 13 from the outside. The outer second valve portion 14 is exposed to the digestive fluid of the abdominal organs 2, but the inner first valve portion 13 does not come into direct contact with the digestive fluid of the abdominal organs 2. Therefore, the second valve portion 14 can prevent the first valve portion 13 from being deteriorated by the acidic digestive fluid, making it easier to maintain the backflow prevention function of the first valve portion 13 for a long period of time.

[0036] The second valve portion 14 is integrated by covering and fixing a thin film tubular body with a valve formed on the other side to the other side of the main body portion 10 having the first valve portion 13. One end portion 14d of the second valve portion 14 is fixed liquid-tight to the outer periphery of the main body portion 10 by, for example, welding or adhesive. This prevents digestive fluid from the abdominal organs 2 from seeping in between the second valve portion 14 and the main body portion 10.

[0037] Similar to the first valve section 13, the second valve section 14 is formed in a tapered shape such that the cross-sectional area of ​​the flow path on one side is smaller than the cross-sectional area of ​​the flow path on the other side. The second valve section 14 has, from one side to the other, a tapered section 14a and an elastically deformable flat section 14b. An outlet 14c is formed on the other side of the flat section 14b. The basic configurations and operations of the tapered section 14a, flat section 14b, and outlet 14c are the same as those of the first valve section 13.

[0038] The second valve portion 14 is formed of a biocompatible and elastically deformable thin film material. Examples of materials for the second valve portion 14 include silicone resin, fluororesin such as PTFE, and polyethylene resin such as ultra-high molecular weight polyethylene. The second valve portion 14 may be formed of the same material as the first valve portion 13, or may be formed of a different material. Furthermore, when the second valve portion 14 is formed of a fluororesin or polyethylene resin that has higher acid resistance than silicone resin, the acid resistance of the second valve portion 14 exposed to digestive fluids of the abdominal organs 2 can be improved.

[0039] Here, the second valve part 14 opens when it receives a pressure from one side that is higher than the opening pressure of the first valve part 13, and allows the body fluid that has passed through the first valve part 13 to flow into the abdominal organ 2. In this way, the second valve part 14 has the function of regulating the inflow rate of the body fluid into the abdominal organ 2.

[0040] The body fluid that has passed through the first valve portion 13 flows into a reservoir portion 16 formed between the second valve portion 14 and the first valve portion 13. When the internal pressure of the reservoir portion 16 becomes higher than the opening pressure of the second valve portion 14, the second valve portion 14 opens, and the body fluid in the reservoir portion 16 flows into the abdominal organs 2.

[0041] The body fluid in storage portion 16 not only presses second valve portion 14 from the inside, but also presses tapered portion 13a and flat portion 13b of first valve portion 13 from the outside. When the internal pressure of storage portion 16 increases while first valve portion 13 is open, a force in the closing direction acts on first valve portion 13 due to the external pressure of the body fluid in storage portion 16 and the restoring force of first valve portion 13. As a result, when the internal pressure of storage portion 16 increases, the opening amount of first valve portion 13 becomes smaller, and the amount of body fluid passing through first valve portion 13 becomes smaller compared to when the internal pressure of storage portion 16 is low.

[0042] On the other hand, when the opening amount of the first valve portion 13 is reduced and the internal pressure of the reservoir portion 16 becomes equal to or greater than the opening pressure of the second valve portion 14, the second valve portion 14 opens. Then, the body fluid in the reservoir portion 16 passes through the second valve portion 14 and flows into the abdominal organs 2, reducing the internal pressure of the reservoir portion 16 and reducing the closing force acting from the outside on the first valve portion 13. This increases the opening amount of the first valve portion 13, and the amount of body fluid passing through the first valve portion 13 increases again. As described above, the fluid-delivery device 1 can adjust the inflow rate of the body fluid into the abdominal organ 2 by using the first valve portion 13 and the second valve portion 14 which have different opening pressures.

[0043] Furthermore, in order to make the opening pressure of the second valve section 14 higher than the opening pressure of the first valve section 13, the second valve section 14 has at least one of the following first to fourth configurations compared to the first valve section 13. Note that, as long as the opening pressure of the second valve section 14 is higher than the opening pressure of the first valve section 13, the second valve section 14 may have any one of the first to fourth configurations, or any combination of two or more of the first to fourth configurations.

[0044] In the first configuration, the film thickness of the second valve portion 14 is thicker than the film thickness of the first valve portion 13. When the film thickness of the valve portion is thicker, the membrane of the valve portion is less likely to bend than when the film thickness is thinner. Therefore, when the film thickness of the valve portion is thicker, the valve portion is more difficult to open, and a greater force is required to open the valve portion.

[0045] In a second configuration, the axial length L2 of the flat portion 14b of the second valve portion 14 is longer than the axial length L1 of the flat portion 13b of the first valve portion 13. When the axial length of the opening / closing portion of the valve portion is longer, the area of ​​the opening / closing portion becomes larger than when the axial length of the opening / closing portion is shorter, and the force acting on the opening / closing portion to open the valve portion is dispersed. Therefore, when the axial length of the opening / closing portion of the valve portion is longer, the valve portion becomes more difficult to open, and a greater force is required to open the valve portion.

[0046] In a third configuration, the opening area of ​​the second valve portion 14 is larger than the opening area of ​​the first valve portion 13. The opening area of ​​the outlet of the valve portion is proportional to the width of the outlet (length in direction D1). Therefore, the width W2 of the outlet 14c of the second valve portion 14 is larger than the width W1 of the outlet 13c of the first valve portion 13. When the opening area of ​​the valve portion is larger, the area of ​​the opening / closing portion becomes larger than when the opening area of ​​the valve portion is small, and the force acting on the opening / closing portion to open the valve portion is dispersed. Therefore, when the opening area of ​​the valve portion is larger, the valve portion becomes more difficult to open, and a greater force is required to open the valve portion.

[0047] As a fourth configuration, the second valve portion 14 is formed from a material that is less susceptible to elastic deformation than the first valve portion 13. As an example, if the material of the first valve portion 13 is silicone resin, a material with a higher Young's modulus than silicone resin, such as PE or PTFE, is used as the material of the second valve portion 14. If the valve portion becomes less susceptible to elastic deformation, it becomes more difficult to open the valve portion, and a greater force is required to open the valve portion.

[0048] The first locking portion 20 is provided in an annular shape on the outer periphery of the main body portion 10, and is arranged axially spaced apart from the first valve portion 13 on one side. The first locking portion 20 is arranged inside the abdominal organ 2 when placed, and when an external force acts on the fluid-delivery device 1 to displace it to one side, the first locking portion 20 catches on the inner surface of the wall 2a of the abdominal organ 2, thereby preventing the fluid-delivery device 1 from slipping out of the abdominal organ 2 and preventing it from escaping into the abdominal cavity 3.

[0049] The first engaging portion 20 has a skeleton portion 21, and the metal skeleton expands and protrudes outward from the other side toward the one side. The skeleton portion 21 is formed, for example, as a separate body from the skeleton portion 11 of the main body portion 10, and is attached to the main body portion 10 by sewing, crimping, or the like. In addition, a thin film cover 22 is attached to the skeleton portion 21 so as to close gaps in the skeleton portion 21.

[0050] The second locking portion 30 is provided in a ring shape on the outer periphery of the main body portion 10, similar to the first locking portion 20, and is arranged on one side of the first locking portion 20 at an interval in the axial direction. The interval between the first locking portion 20 and the second locking portion 30 is dimensioned so that the wall 2a of the abdominal organ 2 can fit between the first locking portion 20 and the second locking portion 30.

[0051] The second locking part 30 is disposed outside the abdominal organ 2 when indwelling, and functions to sandwich the wall 2a of the abdominal organ 2 together with the first locking part 20 to suppress displacement (migration) in the axial direction Ax of the fluid-delivery device 1. In addition, the second locking part 30 also functions to suppress deviation of the fluid-delivery device 1 into the abdominal organ 2 by getting caught on the outer surface of the wall 2a of the abdominal organ 2 when an external force acts on the fluid-delivery device 1 to displace it to the other side.

[0052] The second locking part 30 has a skeleton part 31 and a thin film cover 32 that closes gaps in the skeleton part 31. Similar to the first locking part 20, the second locking part 30 has a shape in which the metal skeleton expands and protrudes outwards from the other side to one side. The shapes of the frameworks 21 and 31 of the first and second locking portions 20 and 30 and the presence or absence of the covers 22 and 32 can be changed as appropriate.

[0053] Next, a description will be given of a procedure for placing the fluid-delivery device 1 in the abdominal organ 2. The procedure for placing the fluid-delivery device 1 is performed, for example, via an endoscope, but this is just one example and is not limiting. First, in order to insert the fluid-delivery device 1, an opening 2b is formed in the wall 2a of the abdominal organ 2 by incision, puncture, or the like using, for example, an ultrasonic endoscope. The size of the opening 2b in the abdominal organ 2 is adjusted appropriately depending on the dimensions of the main body 10 of the fluid-delivery device 1.

[0054] Then, a catheter (not shown) containing the fluid-delivery device 1 contracted radially inward and housed in a cylindrical sheath is inserted into the opening 2b. Thereafter, the sheath of the catheter is moved so as to be pulled out, with the wall 2a of the abdominal organ 2 positioned between the first locking portion 20 and the second locking portion 30 of the fluid-delivery device 1 in the axial direction Ax. This causes the fluid-delivery device 1 to be released from the sheath. At this time, the other side of the fluid-delivery device 1 is disposed in the abdominal organ 2, and one side of the fluid-delivery device 1 is disposed in the abdominal cavity 3.

[0055] The fluid-delivery device 1 self-expands radially outward when released from the sheath. As a result, the expanded main body 10 presses open the opening 2b of the abdominal organ 2 and comes into close contact with the wall 2a, thereby closing the gap between the abdominal organ 2 and the fluid-delivery device 1. Alternatively, an expansion catheter (not shown), which is different from the placement catheter, may be inserted inside the fluid-delivery device 1, and the fluid-delivery device 1 may be expanded radially outward by the expansion of the expansion catheter.

[0056] Furthermore, the first locking portion 20 of the fluid-delivery device 1 expands so as to be wider in the radial direction than the opening inside the abdominal organ 2, and the second locking portion 30 expands so as to be wider in the radial direction than the opening outside the abdominal organ 2. As a result, the wall 2a of the abdominal organ 2 is sandwiched from the inside and outside between the first locking portion 20 and the second locking portion 30. Therefore, even if an external force due to, for example, peristalsis of the abdominal organ 2 or a change in posture such as the patient turning over acts on the fluid-delivery device 1, the fluid-delivery device 1 is unlikely to shift in position in the axial direction Ax relative to the abdominal organ 2.

[0057] In this manner, the fluid-delivery device 1 can be placed inside the patient's body with one side disposed in the abdominal cavity 3 and the other side disposed in the abdominal organ 2 . When the pressure inside the abdominal organs 2 becomes lower than the internal pressure of the abdominal cavity 3 expanded with body fluid, the body fluid flows into the main body 10 through the opening 15 on one side of the main body 10 and the inflow auxiliary hole 15a. The body fluid that flows into the main body 10 passes through the first valve 13 and the second valve 14 in that order and is discharged into the abdominal organs 2. Note that the first valve 13 and the second valve 14 are check valves, and therefore the backflow of body fluids, including digestive juices, into the abdominal cavity 3 is prevented.

[0058] The effects of the liquid delivery device 1 of this embodiment will be described below. The fluid delivery device 1 communicates with abdominal organs 2 (hollow organs) and allows bodily fluids to flow from one side to the other side that is placed inside the abdominal organ 2. The fluid delivery device 1 comprises a cylindrical main body 10 having an opening 15 and an inflow auxiliary hole 15a (inflow portion for bodily fluids) on one side, a first valve 13 that is provided on the other side of the main body 10 and opens and closes by elastic deformation, and a second valve 14 that covers the first valve 13 from the outside and opens and closes by elastic deformation. The fluid-delivery device 1 causes the body fluids stored in the abdominal cavity 3 to flow out into the abdominal organs 2, and the body fluids in the abdominal cavity 3 are returned after being absorbed into the body by the digestive action of the abdominal organs 2. Therefore, the fluid-delivery device 1 can significantly reduce the risk of developing serious complications such as heart failure and blood clot formation compared to when the body fluids in the abdominal cavity 3 are returned directly to the blood vessels. Furthermore, the body fluid flowing through the fluid-delivery device 1 passes through the first valve section 13 and the second valve section 14 in this order. The first valve section 13 opens to allow the body fluid to flow when the pressure of the body fluid on one side is equal to or greater than a predetermined value. The second valve section 14 opens when pressure higher than the opening pressure of the first valve section 13 is received from one side, allowing the body fluid that has passed through the first valve section 13 to flow into the abdominal organ 2. Because the second valve section 14 is harder to open than the first valve section 13, when body fluid accumulates in the second valve section 14, the first valve section 13 is pressed from the outside. This reduces the opening of the first valve section 13, reducing the amount of body fluid passing through the first valve section 13, and adjusting the inflow rate of the body fluid into the abdominal organ 2. Therefore, the fluid-delivery device 1 can prevent the body fluid from the abdominal cavity 3 from excessively flowing into the abdominal organ 2.

[0059] Furthermore, by making the film thickness of the second valve portion 14 thicker than that of the first valve portion 13, the valve portion becomes harder to open, and the opening pressure of the second valve portion 14 can be made higher than the opening pressure of the first valve portion 13. Furthermore, by making the axial length of the flat portion 14b (opening / closing portion) of the second valve portion 14 longer than the axial length of the flat portion 13b of the first valve portion 13, the valve portion becomes less likely to open, and the opening pressure of the second valve portion 14 can be made higher than the opening pressure of the first valve portion 13. Furthermore, by making the opening area of ​​the second valve portion 14 larger than the opening area of ​​the first valve portion 13, the valve portion becomes less likely to open, and the opening pressure of the second valve portion 14 can be made higher than the opening pressure of the first valve portion 13. Furthermore, by forming the second valve portion 14 from a material that is less prone to elastic deformation than the first valve portion 13, the valve portion becomes less likely to open, and the opening pressure of the second valve portion 14 can be made higher than the opening pressure of the first valve portion 13.

[0060] The present invention is not limited to the above-described embodiment, and various improvements and design changes may be made without departing from the spirit of the present invention.

[0061] In the above embodiment, the fluid-delivery device 1 is described, which returns body fluid accumulated in the abdominal cavity to abdominal organs. However, the use of the fluid-delivery device 1 of the present invention is not limited to the above. For example, the fluid-delivery device 1 may be placed so as to connect two hollow organs, and may flow body fluid from a first hollow organ on one side to a second hollow organ on the other side.

[0062] Fig. 6(a) is a schematic diagram showing another example of the indwelling state of the fluid-delivery device 1, and Fig. 6(b) is a diagram partially showing the other side of the fluid-delivery device 1 in the other example of the indwelling state. Fig. 6 shows an example of the fluid-delivery device 1 applied to gallbladder drainage surgery.

[0063] As shown in FIG. 6 , the fluid-delivery device 1 is placed so that the gallbladder 4 on one side communicates with the duodenum 5 on the other side, and bile stored in the gallbladder 4 flows into the duodenum 5. The main body 10 of the fluid-delivery device 1 communicates with the wall 4a of the gallbladder 4 and the wall 5a of the duodenum 5. One side of the main body 10, which has the opening 15 and the auxiliary inflow hole 15a, and the second engaging part 30 are disposed in the gallbladder 4. The first valve part 13, the second valve part 14, and the first engaging part 20 are disposed in the duodenum 5. The fluid-delivery device 1 is placed with the wall 4a of the gallbladder 4 and the wall 5a of the duodenum 5 sandwiched between the first engaging part 20 and the second engaging part 30. 6 allows bile from the gallbladder 4 to flow directly into the duodenum 5, and prevents backflow of bodily fluids from the duodenum 5 into the gallbladder 4. Furthermore, the fluid-delivery device 1 in FIG. 6 also allows the first valve unit 13 and the second valve unit 14 to adjust the rate at which bile flows into the duodenum 5.

[0064] In addition, in the above embodiment, the coating portion 12 is exemplified as being attached to the outer periphery of the skeletal portion 11, but this is just one example and is not limited to this; for example, the coating portion 12 may be attached to the inner periphery of the skeletal portion 11. Furthermore, the main body 10 of the above embodiment may further include a check valve (not shown) on one side in addition to the first valve unit 13 and the second valve unit 14.

[0065] Furthermore, the embodiments disclosed herein should be considered to be illustrative and not restrictive in all respects. The scope of the present invention is defined by the claims, not by the above description, and is intended to include all modifications within the meaning and scope of the claims. [Explanation of symbols]

[0066] 1...fluid delivery device, 2...abdominal organ, 2a...wall, 2b...opening, 3...abdominal cavity, 4...gallbladder, 4a...wall, 5...duodenum, 5a...wall, 10...main body, 11...skeletal part, 11a...extension part, 12...coating part, 13...first valve part, 13a...tapered part, 13b...flat part, 13c...outlet, 14...second valve part, 14a...tapered part, 14b...flat part, 14c...outlet, 14d...end, 15...opening (inlet part), 15a...inlet auxiliary hole (inlet part), 16...storage part, 20...first locking part, 21...skeletal part, 22...cover, 30...second locking part, 31...skeletal part, 32...cover

Claims

1. A fluid delivery device that connects hollow organs and allows bodily fluid to flow from one side to another side that is placed in the hollow organ, a cylindrical main body having an inlet for the bodily fluid on one side; a first valve portion provided on the other side of the main body portion and adapted to open and close by elastic deformation; a second valve portion that covers the first valve portion from the outside and opens and closes by elastic deformation, the first valve portion opens to allow the body fluid to flow when the pressure of the body fluid on one side is equal to or greater than a predetermined value; The second valve portion opens when it receives a pressure higher than the opening pressure of the first valve portion from one side, and allows the body fluid that has passed through the first valve portion to flow into the hollow organ. Fluid delivery device.

2. the first valve portion and the second valve portion are formed of a membrane; The film thickness of the second valve portion is thicker than the film thickness of the first valve portion. The liquid delivery device according to claim 1 .

3. The axial length of the opening / closing portion of the second valve portion is longer than the axial length of the opening / closing portion of the first valve portion. The liquid delivery device according to claim 1 .

4. The opening area of ​​the second valve portion is larger than the opening area of ​​the first valve portion. The liquid delivery device according to claim 1 .

5. The second valve portion is formed of a material that is less susceptible to elastic deformation than the first valve portion. The liquid delivery device according to claim 1 .

6. One side is placed in the abdominal cavity, and the other side is placed in the abdominal organs. The fluid delivery device according to claim 1 , wherein the fluid delivery device is configured to return body fluid in the abdominal cavity to the abdominal organs.

7. 6. The fluid delivery device according to claim 1, which is placed to connect two hollow organs and allows the body fluid to flow from a first hollow organ on one side to a second hollow organ on the other side.

Images