Liquid Delivery Device
The fluid delivery device addresses misalignment and invasiveness issues by using a deformable locking mechanism to secure within the hollow organ, ensuring easy placement and removal.
Patent Information
- Application Number
- JP2022022845
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-02-17
- Publication Date
- 2025-08-08
- Estimated Expiration
- 2042-02-17
AI Technical Summary
Existing stents used for drainage procedures in hollow organs face issues with misalignment during placement and invasiveness during removal, causing stress and prolonging surgery.
A fluid delivery device with a tubular main body, a valve, and locking parts that deform to secure within the hollow organ, allowing fluid flow while minimizing displacement and invasiveness during removal.
The device prevents misalignment and reduces invasiveness during removal by securing within the hollow organ, facilitating easier placement and extraction.
Smart Images

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Abstract
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 applicable to drainage procedures performed under an ultrasound endoscope, which is configured to prevent backflow and allow bodily fluids to flow in one direction into a hollow organ. The stent in Patent Document 1 includes a main body portion that penetrates the inner wall of the hollow organ and is placed in the hollow organ, and a valve portion that prevents backflow of bodily fluids in the main body portion. The stent in Patent Document 1 also has a flange-shaped anchor formed of a skeleton on the outer periphery of the main body portion to anchor the main body portion to the wall of the hollow organ. [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] This type of stent is prevented from shifting from the luminal organ during placement by the anchor in the main body. However, when the stent is removed from the luminal organ, the anchor catches on the wall of the luminal organ, which can put stress on the luminal organ and prolong the removal surgery, raising concerns that this could be highly invasive to the patient.
[0006] Therefore, the present invention has been made in consideration of such problems, and aims to provide a fluid delivery device that can prevent misalignment with a luminal organ when indwelled and reduce invasiveness when removed. [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 the other side of the hollow organ while being placed inside the hollow organ. The fluid delivery device includes a tubular main body having an inlet for bodily fluid on one side, a valve provided on the other side of the main body, and a locking part that protrudes radially from a base end attached to the outer periphery of the main body and that locks onto the wall of the hollow organ through which the main body passes. The locking part deforms from a first shape in which the tip side faces the wall of the hollow organ relative to the base end to a second shape in which the tip side faces the wall of the hollow organ and the axially opposite side of the main body when removed. [Effects of the Invention]
[0008] According to the present invention, it is possible to provide a fluid delivery device that can suppress displacement of the device from a hollow organ when it is placed in place and can reduce invasiveness when it is removed. [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 showing the valve portion on the other side of the liquid delivery device. [Figure 4] FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. [Figure 5] 10A and 10B are diagrams illustrating the deformation of the second locking portion from the first shape to the second shape. [Figure 6] FIG. 1(a) is a diagram partially showing the liquid-delivery device in an indwelling state, and FIG. 1(b) is a diagram partially showing the liquid-delivery device in a removed state. [Figure 7]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 a liquid-delivery device 1 of this embodiment. Fig. 2 is a schematic diagram showing an example of an indwelling state of the liquid-delivery device 1. Fig. 3 is a diagram showing the valve portion on the other side of the liquid-delivery device. Fig. 4 is a cross-sectional view taken along line IV-IV in Fig. 1. Fig. 5 is a view showing the deformation of the second locking part 30 from the first shape to the second shape. Fig. 6(a) is a view partially showing the liquid-delivery device in an indwelling state. Fig. 6(b) is a view partially showing the liquid-delivery device in a removed state.
[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 6(a), 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 engaging portion 20, and a second engaging portion 30. In the indwelling state shown in Figs. 2 and 6(a), 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 has a valve 13 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. 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 except for the tip portion of the 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 shape by adjusting the skeletal portion 11 to its expanded 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 the gaps in the skeleton portion 11. In this embodiment, as shown in Fig. 4, 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 downstream thereof (the area from the first engaging part 20 to the 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] The valve portion 13 is a check valve, which allows bodily fluids to flow from one side to the other side and prevents backflow of bodily fluids from the other side. The 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 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.
[0026] 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. 3.
[0027] Furthermore, a pair of extensions 11a, 11a extending toward the outlet 13c are arranged in the tapered portion 13a of the 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.
[0028] The flat portion 13b is formed in a flat shape such that the dimensions in the first direction D1 and the second direction D2 are maintained along the axial direction Ax, and the membrane body is in close contact with the flat portion 13b 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 organs 2. The dimension of the flat portion 13b in the first direction D1 may vary, for example, along the axial direction Ax.
[0029] When the internal pressure of the bodily fluid on one side of the valve portion 13 is below a predetermined level, the flat portion 13b extends linearly in the first direction D1 and the membrane body adheres tightly to the flat portion 13b in the second direction D2. As a result, when the internal pressure of the bodily fluid on one side of the valve portion 13 is below a predetermined level, the flat portion 13b keeps the outlet 13c closed, making it difficult for the bodily fluid to flow.
[0030] On the other hand, when the internal pressure of the body fluid flowing into 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 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.
[0031] As described above, when the outlet 13c is open, the valve unit 13 allows the body fluid to be discharged from the outlet 13c into the abdominal organ 2, while when the outlet 13c is closed, the valve unit 13 prevents the body fluid, including digestive fluid, from flowing back from the abdominal organ 2 to the fluid-delivery device 1 through the outlet 13c. Note that when discharging the body fluid, the outlet 13c opens into, for example, an elliptical or rectangular shape, but the opening shape of the outlet 13c is not particularly limited as long as it is a shape that allows the body fluid to pass through.
[0032] The valve portion 13 is made of a biocompatible and elastically deformable thin film material, such as silicone resin, fluororesin such as PTFE, or polyethylene resin such as ultra-high molecular weight polyethylene. When the valve portion 13 is made of silicone resin, the valve portion 13 can be formed by dipping on the other side of the main body portion 10. The valve portion 13 may also be formed integrally with the main body portion 10 by the membrane of the coating portion 12.
[0033] The first and second locking parts 20 and 30 are both provided in an annular shape on the outer periphery of the main body part 10, and have a shape in which the tip side protrudes radially from the base end side attached to the outer periphery of the main body part 10. When placed, the first locking part 20 is disposed inside the abdominal organ 2, and is locked from the inside to the wall 2a of the abdominal organ 2 through which the main body part 10 has penetrated. When placed, the second locking part 30 is disposed inside the abdominal cavity 3, and is locked from the outside to the wall 2a of the abdominal organ 2 through which the main body part 10 has penetrated.
[0034] The first locking portion 20 is an example of a positioning portion, and is arranged between the valve portion 13 on the other side and the second locking portion 30 on one side in the axial direction of the main body portion 10. The first locking portion 20 is provided on the main body portion 10 with a distance from the second locking portion 30 on one side that is large enough to allow the wall 2a of the abdominal organ 2 to fit in.
[0035] 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 suppressing deviation into the abdominal cavity 3. The first locking portion 20 and the second locking portion 30 also sandwich the wall 2a of the abdominal organ 2 to position the main body portion 10 in the axial direction.
[0036] The first fastening part 20 has a skeleton 21. The skeleton 21 has a shape in which the metal skeleton widens and protrudes outward from the base end toward the tip end, tapering in diameter toward the wall 2a of the abdominal organ 2 located on one side. The skeleton 21 is formed into a ring shape on the outer periphery of the main body 10 by, for example, hook-braiding metal wires. The skeleton 21 is formed separately from the skeleton 11 of the main body 10, and is attached to the main body 10 by sewing, crimping, or the like.
[0037] As shown in FIGS. 4 and 5, the second locking portion 30 has a skeleton portion 31 and a cover 32 attached to the skeleton portion 31. The skeleton 31 has a metal skeleton formed from elastically deformable wire. The metal skeleton of the skeleton 31 has a shape that widens and protrudes outward from the base end toward the tip end, and is formed into a ring shape on the outer periphery of the main body 10 by, for example, hook-weaving metal wires. The skeleton 31 is formed, for example, separately from the skeleton 11 of the main body 10 and is attached to the main body 10 by sewing, crimping, or the like. Note that forming the skeleton 31 by hook-weaving metal wires makes it easier to maintain the shape of the skeleton in both the first shape and the second shape described below.
[0038] The skeleton 31 of the second engaging part 30 is elastically deformable from a first shape during placement to a second shape during removal, as shown by the solid line in Fig. 5 (left side of Fig. 5). In the first shape, the tip side of the skeleton 31 faces the other side relative to the base end side, and has a shape that tapers in diameter toward the wall 2a of the abdominal organ 2 located on the other side.
[0039] On the other hand, in the second shape, the skeletal portion 31 is deformed so that the tip side rotates to one side from the position of the first shape around the base end side, as shown by the dotted line in Figure 5 (right side of Figure 5), and the tip side faces one side relative to the base end side. As a result, the skeletal part 31 in the second shape is inverted from the first shape and assumes a shape that tapers toward the wall 2a of the abdominal organ 2 located on the other side. When the skeletal part 31 in the second shape receives a force from the other side, the tip side approaches the main body part 10, and the entire second engaging part 30 is deformed so as to narrow further inward.
[0040] 4, the cover 32 of the second locking portion 30 is formed in an annular shape at a radially outer portion of the second locking portion 30, and is attached to the skeleton portion 31 so as to close a gap portion on the tip side of the skeleton portion 31. Therefore, on the base end side of the second locking portion 30, the skeleton portion 31 is not covered by the cover 32 and is exposed.
[0041] The cover 32 is formed of a thin film material that is biocompatible and elastically deformable in response to deformation of the skeleton 31. Examples of materials for the cover 32 include silicone resin. The cover 32 may be formed using a sheet-like material or by dipping or the like. When a sheet-like material is used, the cover 32 may be fixed to the skeleton 31 by any method, such as sewing, bonding, or welding.
[0042] The cover 32 functions to suppress the in-growth of cell tissue into the inside of the skeleton 31 and facilitate the removal of the fluid delivery device 1 after treatment. In addition, the cover 32 does not cover the base end side that bends from the other side to one side when transforming from the first shape to the second shape, and therefore does not hinder the transformation of the second engaging part 30.
[0043] In addition, the cover 32 is attached to the other surface of the skeleton 31. When the cover 32 is attached to the other surface of the skeleton 31, the cover 32 is located closer to the abdominal organ 2 than the skeleton 31 in the first shape, making it less likely that the skeleton 31 will dig into the abdominal organ 2 when the device is indwelled. In addition, in the second shape, the skeleton 31 is inverted so that the cover 32 is located outside the skeleton 31, reducing contact between the opening 2b of the abdominal organ 2 and the skeleton 31 when the fluid-delivery device 1 is removed, making it less likely that the abdominal organ 2 will be damaged. The cover 32 may be attached to one surface of the skeleton 31. When the cover 32 is attached to one surface of the skeleton 31, the cover 32 is positioned outside the skeleton 31 when loading into and releasing from the sheath, which has the advantage of reducing resistance when loading into and releasing from the sheath and enabling smooth placement of the liquid-delivery device 1.
[0044] Next, a procedure for placing the fluid-delivery device 1 in the abdominal organ 2 and a procedure for removing the fluid-delivery device 1 from the abdominal organ 2 will be described. 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.
[0045] 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.
[0046] 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.
[0047] Furthermore, the first engaging part 20 of the fluid-delivery device 1 expands radially beyond the opening 2b inside the abdominal organ 2, and the second engaging part 30 expands radially beyond the opening 2b outside the abdominal organ 2. As a result, the wall 2a of the abdominal organ 2 is sandwiched between the first engaging part 20 and the second engaging part 30 from the inside and outside.
[0048] Here, the second locking part 30 is in the first shape when indwelled. When an external force acts on the fluid-delivery device 1 to displace it to the other side, the second locking part 30 maintains the first shape with the tip side, which extends more radially outward than the opening 2b of the abdominal organ 2, hooked on the outer surface of the wall 2a of the abdominal organ 2, as long as the external force is equal to or less than a predetermined value. In the first shape, the second locking part 30 prevents the fluid-delivery device 1 from escaping into the abdominal organ 2. Therefore, even if an external force acts on the fluid-delivery device 1 due to peristalsis of the abdominal organs 2 or a change in posture such as the patient turning over, the fluid-delivery device 1 is unlikely to shift in position in the axial direction Ax relative to the abdominal organs 2.
[0049] In this way, 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, as shown in FIG. 6(a). When the pressure inside the abdominal organs 2 becomes lower than the internal pressure of the abdominal cavity 3 expanded with body fluid, 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 valve 13 and is discharged into the abdominal organs 2. Note that the valve 13 is a check valve, and therefore body fluid including digestive juices is prevented from flowing back into the abdominal cavity 3.
[0050] When removing the fluid-delivery device 1 from the abdominal organ 2, the fluid-delivery device 1 is grasped inside the abdominal organ 2 using a snare or forceps provided on the ultrasonic endoscope, and the fluid-delivery device 1 is pulled out toward the inside of the abdominal organ 2. Then, an external force exceeding a predetermined value acts on the second engaging part 30 toward the other side, and the second engaging part 30 is deformed from the first shape to the second shape as shown in Fig. 6(b).
[0051] The second engaging portion 30 in the second shape tapers in diameter toward the wall 2a of the abdominal organ 2, so that when an external force acts on the fluid-delivery device 1 to displace it to the other side, the inclined portion of the skeletal portion 31 easily fits into the opening 2b of the abdominal organ 2. Furthermore, when the inclined portion of the skeletal portion 31 in the second shape fits into the opening 2b of the abdominal organ 2, the second engaging portion 30 is pushed from the outside by the wall 2a of the abdominal organ 2 and deforms so as to become even narrower. As a result, the tip side of the second engaging portion 30 in the second shape is less likely to get caught on the wall 2a of the abdominal organ 2, and the fluid-delivery device 1 can be easily removed without imposing a large burden on the patient.
[0052] 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 where it is placed inside the abdominal organ 2. The fluid delivery device 1 includes a cylindrical main body 10 having an opening 15 and an auxiliary inflow hole 15a (inflow portion for bodily fluids) on one side, a valve portion 13 provided on the other side of the main body 10, and a second engaging portion 30 (engaging portion) whose tip side protrudes radially from the base end side attached to the outer periphery of the main body 10 and which engages with the wall 2a of the abdominal organ 2 through which the main body 10 passes. 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 second locking portion 30 deforms from a first shape in which the tip side faces the wall 2a of the abdominal organ 2 relative to the base end to a second shape in which the tip side faces one side (the axially opposite side of the wall 2a of the abdominal organ 2 and the main body portion 10) relative to the base end when removed. As a result, the tip side of the second locking portion 30 in the first shape catches on the wall 2a of the abdominal organ 2, preventing deviation of the fluid delivery device 1 when indwelling. On the other hand, the tip side of the second locking portion 30 in the second shape, facing the opposite side due to deformation, is less likely to catch on the wall 2a of the abdominal organ 2, thereby reducing invasiveness when removed.
[0053] In addition, in the first shape, the second engaging part 30 has a tapered diameter increasing toward the wall 2a of the abdominal organ 2, and in the second shape, the second engaging part 30 has a tapered diameter decreasing toward the wall 2a of the abdominal organ 2. Therefore, in the second shape, which is inverted from the first shape, the second engaging part 30 can easily enter the opening 2b of the abdominal organ 2, making it easier to remove the fluid delivery device 1.
[0054] The second locking part 30 has a skeleton 31 formed of an elastically deformable wire material, so that the elastic deformation of the skeleton 31 makes it possible to easily deform from the first shape to the second shape when the device is removed.
[0055] The second locking portion 30 also has a cover 32 that covers the gaps in the skeleton 31. Therefore, the cover 32 prevents cell tissue from entering the inside of the skeleton 31, making it easy to remove the fluid delivery device 1 after treatment. The cover 32 is formed in a ring shape at a radially outer portion of the second locking portion 30, and the skeleton 31 is exposed on the base end side of the second locking portion 30. Therefore, the cover 32 does not cover the base end side that bends when the second locking portion 30 is transformed from the first shape to the second shape, and therefore does not hinder the transformation of the second locking portion 30.
[0056] The fluid-delivery device 1 further includes a first locking part 20 (positioning part) that is provided on the outer periphery of the main body part 10 at an axial distance from the second locking part 30 and that positions the main body part 10 in the axial direction by sandwiching the wall 2a of the abdominal organ 2 between the first locking part 20 and the second locking part 30. By sandwiching the wall 2a of the abdominal organ 2 between the first locking part 20 and the second locking part 30, axial positional deviation or deviation of the fluid-delivery device 1 during placement becomes less likely to occur.
[0057] 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.
[0058] 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.
[0059] Fig. 7(a) is a schematic diagram showing another example of the indwelling state of the fluid-delivery device 1, and Fig. 7(b) is a diagram partially showing the other side of the fluid-delivery device 1 in the other example of the indwelling state. Fig. 7 shows an example of the fluid-delivery device 1 applied to gallbladder drainage surgery.
[0060] As shown in FIG. 7 , 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 valve part 13 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. According to the fluid delivery device 1 of FIG. 7, bile from the gallbladder 4 can be directly delivered to the duodenum 5, and backflow of bodily fluids from the duodenum 5 to the gallbladder 4 can be prevented.
[0061] Furthermore, in the above embodiment, an example of the configuration of the fluid delivery device 1 has been described in which the second locking part 30, which is deformable from the first shape to the second shape, is arranged on the abdominal cavity 3 side. However, when the fluid delivery device 1 is pulled out toward the abdominal cavity 3 during removal, the second locking part 30 may be arranged on the other side (inside the abdominal organs 2) and the first locking part 20 may be arranged on one side (the abdominal cavity 3 side).
[0062] Furthermore, the configuration of the skeleton 31 of the second engaging part 30 is not limited to the example of the above embodiment in which metal wires are hook-woven to form a tapered shape. For example, the skeleton 31 of the second engaging part 30 may be formed of a rod-shaped member whose tip extends toward the wall 2a of the abdominal organ 2 when indwelling and whose tip rotates in the opposite axial direction when removed.
[0063] 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 have multiple valve units. For example, the valve unit 13 may be doubled by covering it with a thin-film cylindrical valve unit from the outside, or a check valve (not shown) may be provided inside the main body 10 on one side of the valve unit 13. In the above embodiment, a cover for covering the gap of the skeleton 21 may also be attached to the first engagement part 20 arranged inside the abdominal organ 2.
[0064] 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]
[0065] 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 portion, 11...skeleton portion, 11a...extension portion, 12...coating portion, 13...valve portion, 13a...tapered portion, 13b...flat portion, 13c...outlet, 15...opening (inlet portion), 15a...inlet auxiliary hole (inlet portion), 20...first locking portion (positioning portion), 21...skeleton portion, 30...second locking portion (locking portion), 31...skeleton portion, 32...cover
Claims
1. A fluid delivery device that connects hollow organs and allows bodily fluid to flow from one side to another side located within the hollow organ, a cylindrical main body having an inlet for the bodily fluid on one side; a valve portion provided on the other side of the main body portion; a locking portion having a distal end side that protrudes radially from a proximal end side that is attached to the outer periphery of the main body portion and that is locked to the wall of the tubular organ through which the main body portion penetrates, The engaging portion is deformed from a first shape in which the distal end side faces the wall of the hollow organ relative to the base end side to a second shape in which the distal end side faces the wall of the hollow organ and the axial opposite side of the main body portion relative to the base end side when removed. Fluid delivery device.
2. the first shape is a shape in which the engaging portion tapers toward the wall of the hollow organ, The second shape is a shape in which the engaging portion tapers toward the wall of the hollow organ. The liquid delivery device according to claim 1 .
3. The locking portion has a skeleton formed of an elastically deformable wire material. The liquid delivery device according to claim 2 .
4. The engaging portion has a cover that covers the gap in the framework. The liquid delivery device according to claim 3 .
5. The cover is formed in an annular shape at a radially outer portion of the locking portion, The skeleton is exposed on the base end side of the locking portion. The liquid delivery device according to claim 4 .
6. a positioning portion that is provided on the outer periphery of the main body portion at an axial distance from the locking portion and that positions the main body portion in the axial direction by sandwiching the wall between the locking portion and the positioning portion; The liquid delivery device according to claim 1 .
7. 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.
8. 7. 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.
Citation Information
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