JP7778006B2 - Liquid Delivery Device - Google Patents

Description

The present invention relates to a liquid delivery device.

Traditionally, 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.

Patent Document 1 also discloses a stent that can be used in drainage procedures performed under an ultrasound endoscope, and that is configured to prevent backflow and allow bodily fluids to flow in one direction into a hollow organ. 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.

International Publication No. 2021/044837

However, when multiple valve sections are provided, the physical properties of the stent (e.g., flexibility) may change in the areas where the valve sections overlap.

The present invention was made in consideration of these problems, and aims to provide a liquid delivery device that can improve the functionality of the valve units while suppressing changes in the physical properties of the main body unit even when multiple valve units overlap.

One aspect of the present invention is a fluid delivery device that connects a hollow organ and allows a bodily fluid to flow from one side to another side placed within the hollow organ. The fluid delivery device includes a cylindrical main body portion having a cylindrical skeleton and a bodily fluid inlet portion formed on one side thereof, a first valve portion provided on the other side of the main body portion, and a second valve portion covering the first valve portion and the other side of the main body portion from the outside. The skeleton portion of a first region of the main body portion, where the second valve portion and the first valve portion are provided overlapping, has higher axial flexibility than the skeleton portion of a second region on one side of the first region.

The present invention provides a liquid delivery device that can improve the functionality of the valve units while suppressing changes in the physical properties of the main body unit even when multiple valve units overlap.

1A and 1B are diagrams illustrating a configuration example of a liquid delivery device according to a first embodiment. FIG. 10 is a schematic diagram showing an example of an indwelling state of the liquid delivery device. FIG. 10 is a view partially showing the other side of the liquid delivery device in an indwelling state. FIG. 10 is a view showing the valve portion on the other side of the liquid delivery device. FIG. 2A is a diagram showing a cross section of the liquid-pumping device in a first region, and FIG. 2B is a diagram showing a cross section of the liquid-pumping device in a second region. FIG. 10 is a diagram showing a liquid delivery device according to a modified example of the second embodiment; 10A is a diagram showing an example of a skeleton of a second region in the third embodiment, and FIG. 10B is a diagram showing an example of a skeleton of a first region in the third embodiment. 10A is a schematic diagram showing another example of the indwelling state of the liquid-delivery device, and FIG. 10B is a diagram partially showing the other side of the liquid-delivery device in the another example of the indwelling state.

Hereinafter, an example configuration 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.

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

(First embodiment)
Fig. 1 is a diagram showing an example of the configuration of a liquid-feeding device 1 of a first embodiment. Fig. 2 is a schematic diagram showing an example of an indwelling state of the liquid-feeding device 1. Fig. 3 is a diagram partially showing the other side of the liquid-feeding device in the indwelling state. Fig. 4 is a diagram showing a valve portion on the other side of the liquid-feeding device. Fig. 5(a) is a diagram showing a cross section (cross section on a plane perpendicular to the axial direction) of the liquid-feeding device in the first region, and Fig. 5(b) is a diagram showing a cross section of the liquid-feeding device in the second region.

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 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.

As shown in FIG. 1, the fluid delivery device 1 comprises a cylindrical main body 10, one side of which is connected to the other side in the axial direction Ax, and a first locking portion 30 and a second locking portion 40. 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 radial direction are determined appropriately within a range that allows bodily fluid stored in the abdominal cavity 3 to be guided into the abdominal organs 2 without placing undue strain on the patient's body.

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 of the main body 10 has multiple auxiliary inflow holes 15a penetrating the coating 12 from the inside to the outside to assist the inflow of bodily fluids into the main body 10. This allows bodily fluids to flow into the main body 10 through the openings 15 on one side and the auxiliary inflow holes 15a. The auxiliary inflow holes 15a do not necessarily have to be provided on the main body 10.

The skeleton portion 11 is disposed on the main body portion 10 except for the tip portion (flat portion 13b described later) of the first valve portion 13 .
The skeleton 11 has a self-expanding structure that memorizes the shape of the expanded state, 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).

Examples of materials for the skeleton 11 include known metals or metal alloys such as Ni-Ti alloys, stainless steel, titanium alloys, etc. The skeleton 11 may also be made of materials other than metals (for example, ceramics, resins, etc.).
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 the expanded state shape and then subjecting it to a predetermined heat treatment.

Furthermore, the wire of the skeleton 11 may be made of an alloy material that is radiopaque, or a marker piece (not shown) made of an alloy material that is radiopaque may be attached to the wire as appropriate. In these cases, the position of the fluid delivery device 1 can be confirmed from outside the body.

The skeleton 11 also has a first region 21 and a second region 22 that differ in flexibility in the axial direction Ax. The first region 21 is a region located on the other side of the main body 10. As will be described later, the first region 21 corresponds to a portion of the main body 10 where the second valve unit 14 and the first valve unit 13 are provided overlapping each other. The second region 22 is a region located on one side of the main body 10 relative to the second region.
Hereinafter, the skeleton of the first region 21 will also be referred to as skeleton 11a, and the skeleton of the second region 22 will also be referred to as skeleton 11b. When matters common to the skeletons 11a and 11b are described, they will be collectively referred to as skeleton 11.

The skeletal portion 11 has a lattice-like mesh structure formed by weaving metal wires into a fence-like pattern. As shown in Figures 1 and 3, the skeletal portion 11a of the first region 21 has a structure in which the axial spacing of the mesh is smaller than that of the skeletal portion 11b of the second region 22.

In skeletal portion 11a, where the mesh spacing is small in the axial direction, there are more nodes where the wires hook together in the axial direction, and the dimensions of the straight portions of the wires are shorter, compared to skeletal portion 11b, where the mesh spacing is large in the axial direction. In other words, in skeletal portion 11a, the wires that make up the mesh are less linear than in skeletal portion 11b, and there are more nodes that allow bending in the axial direction. As a result, skeletal portion 11a in the first region 21 has greater axial flexibility than skeletal portion 11b in the second region 22, and is more likely to bend in the axial direction than skeletal portion 11b.

The wire diameters of the wires in skeletal portions 11a and 11b may be the same or different. Furthermore, if the wire diameter of the wires in skeletal portion 11a is smaller than the wire diameter of the wires in skeletal portion 11b, the rigidity of skeletal portion 11a in the first region 21 will be reduced, and the axial flexibility of skeletal portion 11a can be increased.

The axial spacing and wire diameter of the mesh in the skeletal portion 11a are determined based on the physical property values of the first region 21 and the second region 22 when the two valve portions (first valve portion 13 and second valve portion 14) described below are overlapped. Specifically, the axial spacing and wire diameter of the mesh in the skeletal portion 11a are determined so as to minimize the difference in physical property values between the first region 21 and the second region 22 that occurs when the valve portions overlap (the difficulty of bending the main body portion 10 due to the overlapping of the valve portions).

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 block any gaps in the skeleton portion 11. In this embodiment, as shown in Figures 5(a) and (b), the coating portion 12 is attached to the outer periphery of the skeleton portion 11. The coating portion 12 can be fixed to the skeleton portion 11 by, for example, forming a coating by dipping, sewing with thread, adhesive bonding, welding, or adhering with tape, etc.

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 condition 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.

In the fluid delivery device 1, the main body 10 is continuously covered by the membrane of the coating 12. As a result, the flow path is integrally formed from the acid-resistant and biocompatible membrane at the portion 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 region between the first engaging portion 30 and the second engaging portion 40), and at the portion downstream thereof that is disposed within the abdominal organ 2 (the region from the first engaging portion 30 to the first valve portion 13).

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

The first valve section 13 and the second valve section 14 are both check valves that allow bodily fluids to flow from one side to the other and prevent backflow of bodily fluids from the other side.

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 flow path cross-sectional area on one side is smaller than the flow path cross-sectional area 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. In addition, an outlet port 13c is formed on the other side of the flat portion 13b.

The tapered portion 13a is formed so that its dimension in a first direction D1, which is perpendicular to the axial direction Ax, is approximately constant, and its dimension in a second direction D2, which is approximately perpendicular to the axial direction Ax and the first direction D1, narrows 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 second direction D2 are shown in Figure 4.

In addition, a pair of extensions 11c, 11c extending toward the outlet 13c are arranged on the tapered portion 13a of the first valve portion 13. The pair of extensions 11c, 11c are made of part of the metal wires that make up the skeleton portion 11a and are arranged facing 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.

Flat portion 13b is a flattened opening/closing portion whose dimensions in the first direction D1 and second direction D2 are maintained along the axial direction Ax, and whose membrane body is substantially in close contact in the second direction D2. An outlet 13c is formed on the other side of flat portion 13b to allow body fluids to flow into abdominal organs 2. The dimension of flat portion 13b in the first direction D1 may vary, for example, along the axial direction Ax.

When the internal pressure of the bodily fluid on one side of the first valve portion 13 is below a predetermined level, the flat portion 13b extends linearly in the first direction D1 and the membrane is tightly attached in the second direction D2. As a result, when the internal pressure of the bodily fluid on one side of the first valve portion 13 is below a predetermined level, the flat portion 13b maintains the outflow port 13c in a closed state, making it difficult for the bodily fluid to flow.

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

As described above, the first valve section 13 allows bodily fluids to be discharged from the outlet 13c into the abdominal organ 2 when the outlet 13c is open, while preventing bodily fluids, including digestive fluids, from flowing back from the abdominal organ 2 to the fluid delivery device 1 through the outlet 13c when the outlet 13c is closed. Note that the outlet 13c opens, for example, in an oval or rectangular shape when discharging bodily fluids, but the opening shape of the outlet 13c is not particularly limited as long as it allows bodily fluids to pass through.

The first valve portion 13 is formed from a biocompatible, 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 from a material with physical properties suitable for a backflow prevention valve, such as silicone resin, regardless of acid resistance.

When the first valve portion 13 is formed from silicone resin, it 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.

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 prevents 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.

The second valve portion 14 is integrated by placing and fixing a thin-film cylindrical body with a valve formed on the other side over 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 fluids from the abdominal organs 2 from seeping in between the second valve portion 14 and the main body portion 10.

The second valve portion 14 also covers the first region 21, in which the skeletal portion 11a, which has high axial flexibility, is disposed. In the first region 21, the second valve portion 14 covers the first valve portion 13 and the main body portion 10, but the axial spacing and wire diameter of the mesh of the skeletal portion 11a are specified to minimize the difference in physical properties (such as flexibility) between the first region 21 and the second region 22. This reduces changes in physical properties in the first region 21 of the main body portion 10 compared to the second region 22. For example, even if the valve portions overlap in the first region 21 of the main body portion 10, the difference in physical properties between the first region 21 and the second region 22 is adjusted to be small, so that axial force is less likely to increase locally compared to the second region 22.

Like the first valve section 13, the second valve section 14 is formed in a tapered shape with the flow path cross-sectional area on one side being smaller than the flow path cross-sectional area 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 structure and operation of the tapered section 14a, flat section 14b, and outlet 14c are the same as those of the first valve section 13.

The second valve portion 14 is formed from 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 from the same material as the first valve portion 13, or from a different material. Furthermore, if the second valve portion 14 is formed from fluororesin or polyethylene resin, which have higher acid resistance than silicone resin, the acid resistance of the second valve portion 14, which is exposed to the digestive fluids of the abdominal organs 2, can be improved.

The first locking portion 30 is provided in an annular shape on the outer periphery of the main body portion 10, and is spaced apart in the axial direction from the first valve portion 13 on one side. When placed in place, the first locking portion 30 is positioned inside the abdominal organ 2, and when an external force acts on the fluid delivery device 1 to displace it to one side, it 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.

The first engagement part 30 has a skeleton part 31, and the metal skeleton expands and protrudes outward from one side to the other. The skeleton part 31 is formed, for example, separately from the skeleton part 11 of the main body part 10, and is attached to the main body part 10 by sewing, crimping, or the like. In addition, a thin film cover 32 is attached to the skeleton part 31 so as to close any gaps in the skeleton part 31.

The second locking portion 40, like the first locking portion 30, is provided in an annular shape on the outer periphery of the main body portion 10 and is spaced apart in the axial direction from the first locking portion 30 on one side. The distance between the first locking portion 30 and the second locking portion 40 is such that the wall 2a of the abdominal organ 2 can fit between the first locking portion 30 and the second locking portion 40.

The second locking portion 40 is positioned outside the abdominal organ 2 when indwelling, and together with the first locking portion 30, it clamps the wall 2a of the abdominal organ 2 to prevent displacement (migration) of the fluid delivery device 1 in the axial direction Ax. Furthermore, when an external force acts on the fluid delivery device 1 to displace it to the other side, the second locking portion 40 catches on the outer surface of the wall 2a of the abdominal organ 2, thereby preventing the fluid delivery device 1 from escaping into the abdominal organ 2.

The second locking portion 40 has a skeleton portion 41 and a thin film cover 42 that closes gaps in the skeleton portion 41. Similar to the first locking portion 30, the second locking portion 40 has a shape in which the metal skeleton expands and protrudes outward from the other side toward one side.
The shapes of the frameworks 31, 41 of the first and second locking portions 30, 40 and the presence or absence of the covers 32, 42 can be changed as appropriate.

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 merely an 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.

A catheter (not shown) containing the fluid delivery device 1, contracted radially inward, in a cylindrical sheath is then inserted into the opening 2b. Thereafter, with the wall 2a of the abdominal organ 2 positioned between the first locking portion 30 and the second locking portion 40 of the fluid delivery device 1 in the axial direction Ax, the catheter sheath is moved so as to be withdrawn. This releases the fluid delivery device 1 from the sheath. At this time, the other side of the fluid delivery device 1 is disposed within the abdominal organ 2, and one side of the fluid delivery device 1 is disposed within the abdominal cavity 3.

When released from the sheath, the fluid delivery device 1 self-expands radially outward. As a result, the expanded main body 10 presses open the opening 2b of the abdominal organ 2 and adheres closely to the wall 2a, sealing 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 inflation of the expansion catheter.

Furthermore, the first locking portion 30 of the fluid delivery device 1 expands radially beyond the opening inside the abdominal organ 2, and the second locking portion 40 expands radially beyond 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 30 and the second locking portion 40. 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.

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 has flowed into the main body 10 passes through the first valve 13 and the second valve 14 in this 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.

The effects of the liquid delivery device 1 of the first embodiment will be described below.
The fluid delivery device 1 communicates with abdominal organs 2 (hollow organs) and allows bodily fluid to flow from one side to the other side placed inside the abdominal organ 2. The fluid delivery device 1 includes a cylindrical main body 10 having an opening 15 (inlet) on one side, a first valve 13 provided on the other side of the main body 10, and a second valve 14 covering the first valve 13 and the other side of the main body 10 from the outside.
The fluid-delivery device 1 causes the body fluid stored in the abdominal cavity 3 to flow out into the abdominal organs 2, and the body fluid in the abdominal cavity 3 is 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 thrombus formation compared to when the body fluid in the abdominal cavity 3 is returned directly to the blood vessels.
In addition, by providing a second valve section 14 in the liquid delivery device 1 that covers the first valve section 13 from the outside, deterioration of the first valve section 13 is suppressed and backflow of body fluids can be more reliably prevented, improving the functionality of the valve section of the liquid delivery device 1.
On the other hand, the first region 21 in the main body 10, where the second valve unit 14 and the first valve unit 13 overlap, has higher axial flexibility than the second region 22 on one side of the first region 21. Therefore, changes in the physical properties of the main body 10 are suppressed in the first region 21 where the second valve unit 14 and the first valve unit 13 overlap, making it easier to maintain uniform physical properties such as flexibility throughout the liquid delivery device 1.

The main body 10 has a skeletal portion 11 with a lattice-like mesh structure, and the mesh of the skeletal portion 11a in the first region 21 has smaller axial spacing than the mesh of the skeletal portion 11b in the second region 22. The wires constituting the mesh in the skeletal portion 11a have lower linearity, and the number of nodes that allow bending in the axial direction is also increased. Therefore, the skeletal portion 11a in the first region 21 has higher axial flexibility than the skeletal portion 11b in the second region 22.

Second Embodiment
6 is a diagram showing a liquid delivery device 1a according to the second embodiment. In the following description of each embodiment, the same components as those of the liquid delivery device 1 according to the first embodiment are denoted by the same reference numerals, and redundant description will be omitted.

In the liquid delivery device 1a shown in Figure 6, the skeleton 11a' of the first region 21 has a structure in which thin metal wires are spirally wound while being folded back in a zigzag pattern. Meanwhile, the skeleton 11b of the second region 22 has a lattice-like mesh structure. The above-mentioned skeletons 11a' and 11b may be formed by weaving wire material made of metal wires, or by laser cutting a thin-walled metal cylinder.

In the liquid delivery device 1a, the skeletal portion 11b of the second region 22 has a lattice-like mesh structure, and the wire in the second region 22 is axially connected at multiple circumferential locations. In contrast, the wire in the skeletal portion 11a' of the first region 21 is spirally wound, so the wire in the first region 21 is axially connected at only one circumferential location. Therefore, the skeletal portion 11a' in the first region 21 has fewer axially connected locations than the skeletal portion 11b of the second region 22, making it more axially flexible than the skeletal portion 11b and more easily bends in the axial direction than the skeletal portion 11b. Therefore, as with the first embodiment, the configuration of the second embodiment can also suppress changes in the physical properties of the main body portion 10 in the first region 21 where the valve portion overlaps.

Furthermore, in the second embodiment, the skeletal portion 11a' of the first region 21 may have a structure in which multiple ring-shaped skeletal pieces are arranged at intervals in the axial direction (not shown). The skeletal pieces have, for example, a shape in which thin metal wires folded back in a zigzag pattern are connected in a ring shape. Even when the ring-shaped skeletal pieces are used as the skeletal portion 11a' in the first region 21, there are fewer axially connected portions than in the skeletal portion 11b of the second region 22, and the axial flexibility can be increased compared to the skeletal portion 11b.

(Third embodiment)
The third embodiment is a configuration example in which the pattern of weaving the wire rods is changed between the first region 21 and the second region 22. Fig. 7(a) shows an example of the skeletal portion 11b of the second region 22 in the third embodiment, and Fig. 7(b) shows an example of the skeletal portion 11a of the first region 21 in the third embodiment.

In the skeleton 11b of the second region 22 shown in Figure 7(a), two wires 51, 52 are woven into a fence-like structure to form a lattice-like mesh structure. In contrast, in the skeleton 11a of the first region 21 shown in Figure 7(b), a single wire 51 is woven into a fence-like structure to form a lattice-like mesh structure.

In the skeleton portion 11b of FIG. 7(a), two wire rods 51, 52 are used, resulting in two wire rod intersections 53 in the circumferential direction (left-right direction in the figure). At the wire rod intersection 53, the dimension of the straight portion of the wire rod is longer, resulting in higher linearity of the skeleton. On the other hand, in the skeleton portion 11a of FIG. 7(b), a single wire rod 51 is used, resulting in only one wire rod intersection 53 in the circumferential direction (left-right direction in the figure). Therefore, the skeleton portion 11a of FIG. 7(b) has fewer wire rod intersections 53 than the skeleton portion 11b, resulting in higher axial flexibility. Therefore, in the configuration of the third embodiment, as in the first embodiment, changes in the physical properties of the main body portion 10 can be suppressed in the first region 21 where the valve portions overlap.

(Fourth embodiment)
In the fourth embodiment, for example, the patterns of the skeletal portions of the first region 21 and the second region 22 may be the same shape, and the wire diameter of the skeletal portion 11a of the first region 21 may be made thinner than the skeletal portion 11b of the second region 22. In this case, too, the rigidity of the skeletal portion 11a in the first region 21 is relatively low, and the axial flexibility of the skeletal portion 11a can be increased. Therefore, in the configuration of the fourth embodiment, as in the first embodiment, changes in the physical properties of the main body portion 10 can be suppressed in the first region 21 where the valve portion overlaps.
The skeletons 11 a and 11 b in the fourth embodiment may have any pattern, and may be formed, for example, using wire rods with different wire diameters, or by laser cutting a thin-walled metal cylinder.

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

In the above embodiment, a fluid delivery device 1 was described that 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 to connect two hollow organs and flow body fluid from a first hollow organ on one side to a second hollow organ on the other side.

Figure 8(a) is a schematic diagram showing another example of the fluid delivery device 1 in an indwelling state, and Figure 8(b) is a diagram partially showing the other side of the fluid delivery device 1 in an indwelling state. Figure 8 shows an example of the fluid delivery device 1 used in gallbladder drainage surgery.

As shown in Figure 8, 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 40 are disposed in the gallbladder 4. The first valve part 13, the second valve part 14, and the first engaging part 30 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 30 and the second engaging part 40.
8 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. 8 also allows the first valve unit 13 and the second valve unit 14 to adjust the inflow rate of bile into the duodenum 5.

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 .

In addition, the embodiments disclosed herein should be considered in all respects to be illustrative and not restrictive. The scope of the present invention is indicated by the claims, not the above description, and is intended to include all modifications within the meaning and scope of the claims.

1, 1a...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, 11a, 11a', 11b...skeleton, 11c...extension, 12...coating, 13...first valve, 13a...tapered portion, 13b...flat portion, 13c...outlet, 14...second valve, 14a...tapered portion, 14b...flat portion, 14c...outlet, 14d...end, 15...opening (inlet), 15a...inlet auxiliary hole, 21...first region, 22...second region, 30...first locking portion, 31...skeleton, 32...cover, 40...second locking portion, 41...skeleton, 42...cover

Claims (6)

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 portion having a cylindrical skeleton portion and an inlet portion for the bodily fluid formed on one side thereof;
a first valve portion provided on the other side of the main body portion;
a second valve portion that covers the first valve portion and the other side of the main body portion from the outside,
A liquid delivery device in which the skeletal portion in a first region in the main body portion where the second valve portion and the first valve portion are overlapped has higher axial flexibility than the skeletal portion in a second region on one side of the first region. the main body portion has the skeleton portion having a lattice-like mesh structure,
The liquid delivery device according to claim 1 , wherein the mesh of the skeletal portion in the first region has a smaller axial spacing than the mesh of the skeletal portion in the second region. the main body portion has the skeleton portion made of a wire material,
The liquid delivery device according to claim 1 , wherein the wire diameter of the skeletal portion in the first region is smaller than the wire diameter of the skeletal portion in the second region. the main body portion has the skeleton portion made of a wire material,
The liquid delivery device according to claim 1 , wherein the skeletal portion in the first region has fewer axially connected portions than the skeletal portion in the second region. The fluid delivery device according to claim 1 , wherein one side is placed in the abdominal cavity and the other side is placed in an abdominal organ. 5. 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.