WO2022065058A1 - Dispositif de recirculation de liquide - Google Patents

Dispositif de recirculation de liquide Download PDF

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Publication number
WO2022065058A1
WO2022065058A1 PCT/JP2021/033165 JP2021033165W WO2022065058A1 WO 2022065058 A1 WO2022065058 A1 WO 2022065058A1 JP 2021033165 W JP2021033165 W JP 2021033165W WO 2022065058 A1 WO2022065058 A1 WO 2022065058A1
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WIPO (PCT)
Prior art keywords
body fluid
recirculation device
fluid recirculation
valve portion
valve
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Application number
PCT/JP2021/033165
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English (en)
Japanese (ja)
Inventor
浩通 伊佐山
誠一 中谷
知明 横田
優子 宮久
Original Assignee
浩通 伊佐山
川澄化学工業株式会社
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Publication date
Application filed by 浩通 伊佐山, 川澄化学工業株式会社 filed Critical 浩通 伊佐山
Priority to JP2022551870A priority Critical patent/JPWO2022065058A1/ja
Publication of WO2022065058A1 publication Critical patent/WO2022065058A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems

Definitions

  • the present invention relates to a body fluid recirculation device.
  • peritoneovenous shunting is known as one of the treatment methods for ascites accumulated in the abdominal cavity.
  • a flow path connecting the abdominal cavity and a vein is formed by a catheter, a stent, or the like, and ascites is returned to the blood vessel by using the pressure difference between the intraperitoneal pressure and the venous pressure.
  • Patent Document 1 describes a catheter for a peritoneovenous shunt, which is implanted in the body from the right subclavian vein to the right atrium, the large vein, the right hepatic vein, penetrates the liver, and reaches the abdominal cavity. It has been disclosed. Further, Patent Document 2 is provided with a valve in which one end is arranged in the intrahepatic vein and the other end is arranged in the abdominal cavity through the liver parenchyma and is opened and closed by the pressure difference between the intraperitoneal cavity and the intrahepatic vein. Stents for peritoneovenous shunts have been disclosed.
  • the catheter for a peritoneovenous shunt as shown in Patent Document 1 is a long catheter that is indwelled over a wide range from the subclavian vein to the abdominal cavity. Therefore, the burden on the patient is large at the time of treatment.
  • the stent for peritoneovenous shunt as shown in Patent Document 2 is placed by a relatively short route from the intrahepatic vein through the hepatic parenchyma to the abdominal cavity.
  • refluxing the stored ascites into the blood vessels may cause serious complications such as heart failure and the tendency for thrombi to form.
  • the present invention has been made in view of such a problem, and a body fluid recirculation device capable of recirculating body fluid such as ascites into the body with relatively minimal invasiveness while suppressing the onset of serious complications.
  • the purpose is to provide.
  • One aspect of the present invention is a body fluid recirculation device including a cylindrical main body.
  • a first end provided on one end side in the axial direction is arranged in the abdominal cavity organ, and a second end provided on the other end side is arranged in the abdominal cavity.
  • a valve portion having an outlet for body fluid is provided at the first end portion on the downstream side in the flow direction of body fluid.
  • the body fluid recirculation device causes the body fluid in the abdominal cavity flowing from the second end to flow out from the outlet of the valve portion and recirculate into the abdominal organ.
  • a body fluid recirculation device capable of recirculating body fluid such as ascites into the body with relatively minimal invasiveness while suppressing the onset of serious complications.
  • FIG. 4 It is a figure which shows the structural example of the body fluid recirculation device of this embodiment. It is a schematic diagram which shows the use state of a body fluid recirculation device.
  • A is a diagram showing a part of the body fluid recirculation device in the indwelling state on one end side, and
  • (b) is a diagram showing a valve portion on one end side of the body fluid recirculation device.
  • A) is a view showing a body fluid recirculation device from the other end side
  • (b) is a sectional view taken along line IVb-IVb of FIG. 4 (a)
  • (c) is a sectional view taken along line IVc-IVc of FIG. 4 (a). Is.
  • FIG. 8 is a cross-sectional view taken along the line IX-IX of FIG.
  • the body fluid recirculation device according to the embodiment of the present invention will be described with reference to the drawings.
  • the shapes, dimensions, etc. of each part in the drawings are schematically shown, and do not show the actual shapes, dimensions, etc.
  • the axial Ax of the body fluid recirculation device is indicated by an arrow as needed.
  • a direction substantially orthogonal to the axial direction Ax is defined as a radial direction.
  • one end side of the body fluid recirculation device is indicated by reference numeral F and the other end side thereof is indicated by reference numeral B in the drawings.
  • FIG. 1 is a diagram showing a configuration example of the body fluid recirculation device 1.
  • FIG. 2 is a schematic view showing a usage state of the body fluid recirculation device 1.
  • FIG. 3A is a diagram showing a part of the body fluid recirculation device 1 in the indwelling state on one end side
  • FIG. 3B is a diagram showing a valve portion on one end side of the body fluid recirculation device 1.
  • 4 (a) is a view showing the body fluid recirculation device 1 from the other end side
  • FIG. 4 (b) is a sectional view taken along the line IVb-IVb of FIG. 4 (a)
  • FIG. 4 (c) is a cross-sectional view of FIG. 4 (a).
  • the body fluid recirculation device 1 is a device having a tubular shape as a whole.
  • the body fluid recirculation device 1 is used to recirculate ascites (body fluid), which is excessively stored in the abdominal cavity and contains useful components such as leukocytes and proteins, to the abdominal cavity organ 2 (for example, stomach).
  • body fluid body fluid
  • the abdominal cavity organ 2 for example, stomach
  • the body fluid recirculation device 1 is inserted and placed in the opening 2b formed in the wall 2a of the abdominal organ 2.
  • One end side of the body fluid recirculation device 1 is a downstream side in the flow direction of the body fluid, and is disposed in the abdominal organ 2.
  • the other end side of the body fluid recirculation device 1 is an upstream side in the flow direction of the body fluid, and is disposed in the abdominal cavity 3.
  • the abdominal organ 2 include, but are not limited to, digestive organs such as the stomach, duodenum, small intestine, and large intestine, and the digestive tract.
  • the body fluid recirculation device 1 has a cylindrical main body portion 10 in which one end side and the other end side in the axial direction communicate with each other, and a first locking portion 20 and a second locking portion 20 as an example of a positioning portion.
  • a unit 30 is provided.
  • the internal space of the main body 10 forms a flow path through which the body fluid can pass from the other end side to the one end side.
  • the axial Ax and radial dimensions of the main body 10 are appropriately set as long as the body fluid stored in the abdominal cavity 3 can be guided into the abdominal organ 2 without applying an excessive load to the patient's body. Can be adjusted.
  • the main body portion 10 has a tubular skeleton portion 11 and a coating portion 12 fixed to the skeleton portion 11. Further, the main body portion 10 has a valve portion 13 at the first end portion 10a on one end side in the axial direction Ax, and an inflow assisting portion 14 at the second end portion 10b on the other end side in the axial direction Ax.
  • the skeleton portion 11 is arranged on the main body portion 10 except for the flat region on the distal end side of the valve portion 13.
  • the skeleton portion 11 has a so-called self-expanding structure in which the shape of the expanded state is stored, and can be expanded or contracted from a contracted state contracted inward in the radial direction to an expanded state expanded outward in the radial direction.
  • the body fluid recirculation device 1 is housed in a sheath in a state of being contracted inward in the radial direction (not shown), and is introduced into the patient's body via an ultrasonic endoscope (EUS: Endoscopic Ultrasonography).
  • EUS Endoscopic Ultrasonography
  • the skeleton portion 11 is formed by weaving a wire rod made of a metal wire into a fence shape.
  • the material of the wire rod of the frame portion 11 include known metals or metal alloys typified by Ni—Ti alloy, stainless steel, titanium alloy and the like.
  • the skeleton portion 11 may be made of a material other than metal (for example, ceramic or resin).
  • an alloy material having X-ray contrast property may be used for the wire rod of the skeleton portion 11, or a marker piece (not shown) formed of the alloy material having X-ray contrast medium may be appropriately attached to the wire rod. .. In these cases, the position of the body fluid recirculation device 1 can be confirmed from outside the body.
  • the shape of the expanded state is stored in the skeleton portion 11 by subjecting the skeleton portion 11 to the shape of the expanded state and then performing a predetermined heat treatment. Can be done.
  • the configuration of the skeleton portion 11 is not limited to the above.
  • the metal wire may be knitted in a grid pattern or a spiral shape by another knitting method to form the skeleton portion 11.
  • the thin-walled cylindrical body made of the above-mentioned various metals may be laser-cut to form a skeleton portion 11 such as a pattern in which fine metal wires are spirally wound while being folded back in a zigzag pattern.
  • the coating film portion 12 is a tubular flexible film body forming the above-mentioned flow path, and is attached to the skeleton portion 11 so as to close the gap portion of the skeleton portion 11.
  • the coating portion 12 is attached to the outer peripheral side of the skeleton portion 11.
  • the method of fixing the coating portion 12 to the skeleton portion 11 may be, for example, any of forming a coating by dipping, sewing with a thread, adhesion, welding, sticking with a tape or the like.
  • the coating portion 12 is made of a material having acid resistance and biocompatibility because it is used in an environment in which the abdominal cavity organ 2 is exposed to the digestive juice (for example, gastric juice) of the abdominal cavity organ.
  • the material of the coating portion 12 include a fluororesin such as PTFE (polytetrafluoroethylene) and a polyethylene resin such as ultra-high molecular weight polyethylene.
  • Ultra high molecular weight polyethylene is polyethylene having a molecular weight of 1 to 7 million.
  • the valve portion 13 on one end side to the second end portion 10b on the other end side are continuously covered with the membrane body of the coating portion 12.
  • a portion facing the opening 2b of the wall 2a of the abdominal organ 2 and passing through the wall 2a of the abdominal organ 2 for example, a region between the first locking portion 20 and the second locking portion 30
  • the site (the region from the first locking portion 20 to the valve portion 13) disposed in the abdominal cavity organ 2 on the downstream side thereof is a membrane body having acid resistance and biocompatibility, and the flow path is integrally formed. Will be done.
  • the membrane body disposed in the portion passing through the wall 2a of the abdominal organ 2 and the portion disposed in the abdominal organ 2 on the downstream side thereof has acid resistance, and other than these.
  • the physical properties of the film body disposed in the above may be different for each part of the film body, such as not having acid resistance.
  • the valve portion 13 is a check valve for preventing backflow of body fluid from one end side. Further, the valve portion 13 is formed by covering a pair of extending portions 11a and 11a extending toward the outlet 13c with a film body of the coating portion 12.
  • the pair of extending portions 11a, 11a are composed of a part of the metal strands constituting the skeleton portion 11, are arranged so as to face each other with the tube axis of the main body portion 10 interposed therebetween, and face each other in the radial direction of the main body portion 10.
  • the height of one mountain is higher than the height of the other.
  • the valve portion 13 is formed in a tapered shape in which the flow path cross-sectional area on one end side is smaller than the flow path cross-sectional area on the other end side as a whole.
  • the valve portion 13 has a tapered portion 13a and a flat portion 13b from the other end side toward one end side.
  • the dimension of the first direction D1 orthogonal to the axial direction Ax is substantially constant, and the dimension of the second direction D2 substantially orthogonal to the axial direction Ax and the first direction D1 is from the other end side to one end side. It is formed in a shape that narrows as it goes toward it. That is, in the tapered portion 13a, the cross-sectional area of the flow path gradually decreases from the other end side to the one end side.
  • the first direction D1 and the second direction D2 are shown in FIG. 3 (b).
  • the flat portion 13b is formed in a flat shape in which the dimensions of the first direction D1 and the second direction D2 are held along the axial direction Ax, and the film body is substantially in close contact with the second direction D2. Further, on one end side of the flat portion 13b, an outlet 13c is formed to allow body fluid to flow out into the abdominal organ 2.
  • the flat portion 13b When the body fluid does not flow in the body fluid recirculation device 1, the flat portion 13b extends linearly in the first direction D1 and the membrane body adheres in the second direction D2 to maintain the outlet 13c in a closed state. Will be done.
  • the flat portion 13b when the body fluid is flowing in the body fluid recirculation device 1, the flat portion 13b is expanded by the internal pressure of the body fluid, the membrane body is separated in the second direction D2, and the outlet 13c is opened.
  • the valve portion 13 allows the discharge of the body fluid from the outlet 13c into the abdominal organ 2, while suppressing the backflow of the body fluid containing the digestive fluid from the abdominal organ 2 to the body fluid recirculation device 1. ..
  • the outlet 13c opens in an elliptical shape or a rectangular shape, for example, when the body fluid is discharged, but the opening shape of the outlet 13c is not particularly limited as long as the body fluid can pass therethrough.
  • the inflow assisting portion 14 has a structure that allows the inflow of body fluid from the side surface of the main body portion 10, and has a function of assisting the inflow of body fluid into the main body portion 10.
  • the inflow assisting portion 14 is provided with a large number of through holes 14a that penetrate the coating portion 12 in and out.
  • the through hole 14a of the inflow assisting portion 14 is formed in a size that allows a component of body fluid (for example, protein or the like) to pass through. Specifications such as the size and shape of the through hole 14a can be changed as appropriate, and detailed description thereof will be omitted here.
  • the opening portion 15 of the second end portion 10b of the main body portion 10 may be covered with the coating portion 12 to form a through hole 14a in the covered portion.
  • the body fluid recirculation device 1 when the pressure in the abdominal organ 2 is smaller than the internal pressure of the abdominal cavity 3 inflated by the body fluid, the body fluid flows into the main body 10 from the opening 15 of the second end 10b of the main body 10. The body fluid also flows into the main body 10 through the through hole 14a of the inflow assisting portion 14. This makes it possible to efficiently guide the body fluid of the abdominal cavity 3 into the abdominal organ 2 via the body fluid recirculation device 1.
  • body fluid is supplied from the through hole 14a of the inflow assisting portion 14 to the main body portion 10. Can be inflowed. This makes it possible to reduce the possibility that the flow of body fluid into the abdominal organ 2 by the body fluid recirculation device 1 is obstructed even during treatment.
  • the first locking portion 20 is provided in an annular shape on the outer periphery of the main body portion 10, and is arranged on the other end side of the valve portion 13 with an axial interval. Further, the first locking portion 20 has a skeleton portion 21, and has a shape in which the metal skeleton expands to the outer peripheral side and protrudes from one end side toward the other end side.
  • the skeleton portion 21 may be formed separately from the skeleton portion 11 of the main body portion 10, and may be attached to the main body portion 10 by sewing, caulking, or the like. Further, the skeleton portion 21 may be integrally formed of, for example, the same wire rod as the skeleton portion 11 of the main body portion 10.
  • the first locking portion 20 is arranged inside the abdominal organ 2 at the time of indwelling, and is caught on the inner surface of the wall 2a of the abdominal organ 2 when an external force that displaces the body fluid recirculation device 1 toward the other end is applied. It has a function of preventing the body fluid recirculation device 1 from coming off the abdominal organ 2 and suppressing the deviation to the abdominal cavity 3.
  • the second locking portion 30 is provided in an annular shape on the outer periphery of the main body portion 10, and is arranged on the other end side from the first locking portion 20 with an axial interval. ..
  • the distance between the first locking portion 20 and the second locking portion 30 is appropriately set so that the wall 2a of the abdominal organ 2 can be inserted between the first locking portion 20 and the second locking portion 30.
  • the second locking portion 30 has a skeleton portion 31 and a cover 32 that covers the entire skeleton portion 31.
  • the skeleton portion 31 is made of a flange-shaped metal skeleton in which wire rods folded back so as to be convex on the outer peripheral side are arranged in an annular shape in the circumferential direction of the main body portion 10.
  • the skeleton portion 31 has a shape that rises toward the outer peripheral side from both sides of one end side and the other end side toward the center in the axial direction in the axial direction Ax.
  • the skeleton portion 31 is formed separately from the skeleton portion 11 of the main body portion 10, for example, and is attached to the main body portion 10 by sewing, caulking, or the like, similarly to the skeleton portion 21 of the first locking portion 20. You may. Further, the skeleton portion 31 may be integrally formed of, for example, the same wire rod as the skeleton portion 11 of the main body portion 10.
  • the cover 32 of the second locking portion 30 is made of a thin film material that has biocompatibility and is elastically deformable following the deformation of the skeleton portion 31.
  • Examples of the material of the cover 32 include silicon, and a sheet-like material may be used, or the cover 32 may be formed by dipping or the like.
  • the cover 32 does not need to be provided so as to cover the entire skeleton portion 31, and may be configured to cover only the portion of the skeleton portion 31 on the stomach wall side (the side in contact with the stomach wall).
  • the cover 32 is attached to the metal skeleton of the skeleton portion 31 so as to close the gap portion of the skeleton portion 31.
  • the cover 32 has a function of suppressing the invasion (ingulose) of the cell tissue into the inside of the skeletal portion 31 in order to facilitate the removal of the body fluid recirculation device 1 after the treatment.
  • the method of fixing the cover 32 to the skeleton portion 31 may be, for example, sewing, adhesion, welding or the like.
  • the second locking portion 30 (particularly, the skeleton portion 31) is arranged outside the abdominal organ 2 at the time of indwelling, and sandwiches the wall 2a of the abdominal organ 2 together with the first locking portion 20 (skeleton portion 21) to recirculate the body fluid. It has a function of suppressing the positional deviation (migration) of the axial Ax of 1. Further, the second locking portion 30 (particularly, the skeleton portion 31) is caught on the outer surface of the wall 2a of the abdominal organ 2 when an external force that displaces the body fluid recirculation device 1 toward one end is applied to the body fluid recirculation. It also has the function of suppressing the deviation of the device 1 into the abdominal organ 2.
  • the radial dimension of the second locking portion 30 may be the same as or different from the radial dimension of the first locking portion 20.
  • the radial dimension of the second locking portion 30 is larger than the radial dimension of the first locking portion 20. Is also preferable.
  • the procedure for indwelling the body fluid recirculation device 1 in the abdominal organ 2 will be described.
  • the procedure for indwelling the body fluid recirculation device 1 is performed endoscopically, for example, but is an example and is not limited to this.
  • an opening 2b is formed in the wall 2a of the abdominal organ 2 by incision or puncture using an ultrasonic endoscope.
  • the size of the opening 2b of the abdominal organ 2 is appropriately set according to the size of the main body 10 of the body fluid recirculation device 1.
  • a catheter (not shown) in which the body fluid recirculation device 1 contracted inward in the radial direction is housed in a tubular sheath is inserted through the above opening. Then, with the wall 2a of the abdominal organ 2 located between the first locking portion 20 and the second locking portion 30 of the body fluid recirculation device 1 in the axial direction Ax, the catheter is moved so as to pull out the sheath. Then, the body fluid recirculation device 1 is released from the sheath. At this time, the first end portion 10a of the body fluid recirculation device 1 is disposed in the abdominal cavity organ 2, and the second end portion 10b of the body fluid recirculation device 1 is disposed in the abdominal cavity 3.
  • the body fluid recirculation device 1 self-expands radially outward by being released from the sheath.
  • the expanded main body 10 is brought into close contact with the wall 2a so as to expand the opening 2b of the abdominal organ 2, and the gap between the abdominal organ 2 and the body fluid recirculation device 1 is closed.
  • An expansion catheter (not shown) different from the indwelling catheter may be inserted inside the body fluid recirculation device 1 and the body fluid recirculation device 1 may be expanded radially outward by the expansion of the expansion catheter.
  • the first locking portion 20 of the body fluid recirculation device 1 expands inside the abdominal organ 2 so as to expand radially from the opening, and the second locking portion 30 expands radially outside the abdominal organ 2 from the opening. Expand to expand to.
  • the wall 2a of the abdominal organ 2 is sandwiched between the first locking portion 20 and the second locking portion 30 from inside and outside. Therefore, for example, even if an external force due to a change in posture such as peristalsis of the abdominal organ 2 or turning over of the patient acts on the body fluid recirculation device 1, the body fluid recirculation device 1 is less likely to be displaced in the axial direction Ax with respect to the abdominal organ 2.
  • the first locking portion 20 is caught on the inner surface of the wall 2a of the abdominal organ 2 and is displaced (arrow A; FIG. 3A). It becomes a resistance to the force of (see), and the body fluid recirculation device 1 is prevented from coming off with respect to the other end side. As a result, the deviation of the body fluid recirculation device 1 to the abdominal cavity 3 is suppressed by the first locking portion 20.
  • the second locking portion 30 is caught on the outer surface of the wall 2a of the abdominal organ 2 and is displaced (arrow B; see FIG. 3A). ), And the body fluid recirculation device 1 is prevented from coming off with respect to one end side. As a result, the second locking portion 30 suppresses the deviation of the body fluid recirculation device 1 into the abdominal organ 2.
  • the body fluid recirculation device 1 can be placed in the patient's body with the first end portion 10a disposed in the abdominal cavity organ 2 and the second end portion 10b disposed in the abdominal cavity 3.
  • the body fluid flows into the main body 10 from the opening 15 of the second end 10b of the main body 10 and the inflow assisting portion 14.
  • the body fluid that has flowed into the main body 10 flows toward one end of the main body 10 and is discharged into the abdominal organ 2 from the outlet 13c of the valve portion 13. Since the valve portion 13 is a backflow prevention valve, the backflow of body fluid containing digestive juice from the abdominal organ 2 to the abdominal cavity 3 is suppressed.
  • the effect of the body fluid recirculation device 1 of the present embodiment will be described.
  • the first end 10a provided on one end side in the axial direction Ax is arranged in the abdominal cavity organ 2, and the second end provided on the other end side.
  • the portion 10b is disposed in the abdominal cavity 3.
  • the first end portion 10a is provided with a valve portion 13 having a body fluid outlet 13c on the downstream side in the body fluid flow direction.
  • the body fluid recirculation device 1 causes the body fluid in the abdominal cavity 3 flowing from the second end portion 10b to flow out from the outlet 13c of the valve portion 13 and recirculate into the abdominal organ 2.
  • the body fluid recirculation device 1 causes the body fluid stored in the abdominal cavity 3 to flow out into the abdominal organ 2, the body fluid in the abdominal cavity 3 is recirculated through the process of being absorbed into the body by the digestive action of the abdominal organ 2. .. Therefore, according to the body fluid recirculation device 1, the risk of developing serious complications such as heart failure and thrombus formation can be significantly suppressed as compared with the case where the body fluid of the abdominal cavity 3 is directly recirculated into the blood vessel. Moreover, since the body fluid of the abdominal cavity 3 does not directly return to the blood vessel, treatment using the body fluid return device 1 can be expected even for a case unsuitable for the conventional peritoneovenous shunt operation, for example.
  • the body fluid recirculation device 1 directly connects the abdominal cavity 3 and the abdominal organ 2, the axial length of the device is shorter than that of the conventional peritoneal venous shunt operation, which is a burden on the patient's body during the operation and after the indwelling. Will also decrease. Therefore, according to the body fluid recirculation device 1, the body fluid of the abdominal cavity 3 can be recirculated more appropriately into the body with less invasiveness as compared with the conventional case.
  • the body fluid recirculation device 1 further includes a positioning unit (for example, a first locking portion 20 and a second locking portion 30) for positioning the outlet 13c so as to be arranged in the abdominal organ 2.
  • the outlet 13c of the body fluid recirculation device 1 is positioned in the abdominal cavity organ 2 by the positioning portion, so that the axial position shift of the body fluid recirculation device 1 and the deviation of the body fluid recirculation device 1 into the abdominal cavity 3 and the abdominal organ 2 Can be suppressed.
  • a membrane body having resistance to digestive juice in the abdominal organ 2 (for example, the coating portion 12). Is formed into a tubular shape. As a result, it is possible to suppress an event in which the main body 10 is damaged by the digestive juice of the abdominal cavity organ 2 and the body fluid containing the digestive juice leaks to the abdominal cavity 3 side.
  • the second end portion 10b of the main body portion 10 has an inflow assisting portion 14 that assists the inflow of body fluid into the main body portion 10.
  • the body fluid flows into the main body portion 10 even through the inflow assisting portion 14, so that the body fluid of the abdominal cavity 3 is efficiently passed through the body fluid recirculation device 1. It becomes possible to guide it into the organ 2.
  • the shape of the second locking portion 30 exemplified in the above embodiment is an example and is not limited to this, and can be arbitrarily changed as appropriate.
  • the metal skeleton of the second locking portion 30A becomes outer peripheral as the second locking portion 30A moves from the other end side to the one end side, similarly to the first locking portion 20. It has a shape that spreads to the side and protrudes.
  • the axial length of the main body portion 10 can be arbitrarily changed, for example, depending on the placement site.
  • the axial length of the main body portion 10 is shorter than that of the body fluid recirculation device 1 of the embodiment.
  • the configuration in which the skeleton portion 21 of the first locking portion 20 is not covered with the cover is exemplified, but the configuration is merely an example and the present invention is not limited to this. That is, as shown in FIG. 6, in the body fluid recirculation device 1B of the second modification, the skeleton portion 21 of the first locking portion 20 is covered with the cover 22 as in the second locking portions 30, 30A and 30B. ing. As a result, the tip of the skeleton portion 21 of the first locking portion 20 is less likely to bite into the wall 2a of the abdominal organ 2, and the body fluid recirculation device 1B indwelled in the abdominal organ 2 is more easily removed.
  • the second locking portion 30B has a shape in which the metal skeleton expands and protrudes toward the outer peripheral side from one end side toward the other end side, similarly to the first locking portion 20. Is doing. In the case of such a shape, when the body fluid recirculation device 1B indwelled in the abdominal organ 2 is pulled from the abdominal organ 2 side and removed, the second locking portion is compared with the second locking portion 30A of the modified example 1. 30B is less likely to become a resistance, and removal becomes easier.
  • the inflow assisting portion 14 in the body fluid recirculation device 1 by providing a plurality of through holes 14a in the coating portion 12 has been described, but the configuration of the inflow assisting portion 14 is not limited to the above. do not have.
  • the body fluid recirculation device 1C of the modified example 3 has an inflow assisting portion by covering the periphery of the skeleton portion 11 with a mesh-like porous membrane 16 on the second end portion 10b side of the main body portion 10. 14 may be configured.
  • the same effect as that of the above embodiment can be obtained by the body fluid recirculation device 1C of the modified example 3.
  • both the first locking portion 20 and the second locking portions 30, 30A and 30B were provided as the positioning portions, but the body fluid recirculation devices 1, 1A, 1B and 1C fell into the abdominal cavity 3. At least the first locking portion 20 may be provided in order to suppress the above. Similarly, in order to prevent the body fluid recirculation devices 1, 1A, 1B, and 1C from falling into the abdominal organ 2, at least the second locking portions 30, 30A, and 30B may be provided.
  • FIG. 8 is a partial perspective view showing one end side of the body fluid recirculation device 1D of the modified example 4.
  • FIG. 9 is a cross-sectional view taken along the line IX-IX of FIG.
  • the body fluid recirculation device 1D shown in FIGS. 8 and 9 includes a first valve portion 17 and a second valve portion 18 on one end side disposed in the abdominal organ 2.
  • the configuration of the body fluid recirculation device 1D other than the first valve portion 17 and the second valve portion 18 is the same as that of the body fluid recirculation device 1B shown in FIG. It is possible to change.
  • the first valve portion 17 is a check valve connected to one end side of the main body portion 10 and has a function of preventing backflow of body fluid from one end side to the other end side.
  • the first valve portion 17 is integrally formed with the main body portion 10, and is formed in a tapered shape in which the flow path cross-sectional area on one end side is smaller than the flow path cross-sectional area on the other end side as a whole.
  • the first valve portion 17 has a tapered portion 17a and a flat portion 17b from the other end side toward one end side. Further, an outlet 17c is formed on one end side of the flat portion 17b. Since the configuration and operation of the first valve portion 17 are the same as those of the valve portion 13, duplicate description will be omitted.
  • the first valve portion 17 is made of a thin film material that is biocompatible and elastically deformable.
  • the material of the first valve portion 17 include silicon, a fluororesin such as PTFE, and a polyethylene resin such as ultra-high molecular weight polyethylene. Since the first valve portion 17 does not come into direct contact with the digestive juice due to the second valve portion 18, the first valve portion 17 has physical characteristics suitable for a check valve such as silicon regardless of acid resistance. Materials can be used.
  • the first valve portion 17 When the first valve portion 17 is formed of silicon, the first valve portion 17 can be formed on one end side of the main body portion 10 by dipping. Further, when the first valve portion 17 is formed of a fluororesin or a polyethylene resin, the first valve portion 17 can be formed by the same method as the above-mentioned valve portion 13.
  • the second valve portion 18 is a check valve attached to the main body portion 10 on one end side of the main body portion 10.
  • the second valve portion 18 is attached to the outside of the first valve portion 17 and covers the first valve portion 17 from the outside.
  • the second valve portion 18 has a function of preventing backflow of body fluid from one end side to the other end side and suppressing deterioration of the first valve portion 17 by being exposed to digestive juice in the abdominal organ 2. Carry.
  • the second valve portion 18 is formed in a tapered shape in which the flow path cross-sectional area on one end side is smaller than the flow path cross-sectional area on the other end side as a whole.
  • the second valve portion 18 has a tapered portion 18a and a flat portion 18b from the other end side toward one end side. Further, an outlet 18c is formed on one end side of the flat portion 18b. Since the configuration and operation of the second valve portion 18 are the same as those of the above-mentioned valve portion 13, duplicate description will be omitted.
  • the second valve portion 18 is integrated by covering and fixing a thin-film tubular body having a valve formed on one end side on one end side of the main body portion 10 having the first valve portion 17.
  • the other end 18d of the second valve portion 18 is liquid-tightly fixed to the outer periphery of the main body portion 10 by, for example, welding, adhesion, or the like. As a result, the infiltration of the digestive juice of the abdominal organ 2 from between the other end portion 18d and the main body portion 10 is suppressed.
  • the second valve portion 18 does not have to have a skeleton, and may have a skeleton.
  • the second valve portion 18 is made of a thin film material that is biocompatible and elastically deformable.
  • the material of the second valve portion 18 include silicon, a fluororesin such as PTFE, and a polyethylene resin such as ultra-high molecular weight polyethylene.
  • the second valve portion 18 may be made of the same material as the first valve portion 17, or may be made of a different material. Further, when the second valve portion 18 is formed of a fluororesin or polyethylene resin having a higher acid resistance than silicon, the acid resistance of the second valve portion 18 exposed to the digestive juice of the abdominal organ 2 can be improved. .. Further, both the first valve portion 17 and the second valve portion 18 may be formed of silicon.
  • the main body 10 of the body fluid recirculation device 1D may further include a check valve (not shown) on the other end side in addition to the first valve portion 17 and the second valve portion 18.
  • the first valve portion 17 and the second valve portion 18 do not have to be arranged so as to partially overlap each other in the axial direction, and the first valve portion 17 and the second valve portion 18 are separated in the axial direction. May be arranged.
  • both of the two valve portions do not have to be arranged on one end side of the main body portion 10, one valve portion is arranged in the abdominal organ, and the other valve portion is inside the main body portion and is axially oriented. It may be arranged so as to be located outside the abdominal organ (not shown).
  • one of the valves arranged in the abdominal organ is preferably formed of a material having high acid resistance.
  • the body fluid recirculation device 1D has a first valve portion 17 connected to the main body portion 10 and a second valve portion 18 covering the first valve portion 17 from the outside as a valve portion on one end side. .. According to the body fluid recirculation device 1D, even if one of the first valve portion 17 and the second valve portion 18 is damaged due to tearing or the like, the other of the first valve portion 17 and the second valve portion 18 is prevented from flowing back. It functions as a valve and suppresses the backflow of the digestive juice of the abdominal organ 2 to the other end side of the body fluid recirculation device 1D.
  • the event that the body fluid containing the digestive fluid leaks to the abdominal cavity 3 side can be more reliably suppressed as compared with the configuration having no plurality of valve portions.
  • the second valve portion 18 covers the first valve portion 17 from the outside. Therefore, the outer second valve portion 18 is exposed to the digestive juice of the abdominal organ 2, but the inner first valve portion 17 does not come into direct contact with the digestive juice of the abdominal organ 2. Therefore, deterioration of the first valve portion 17 due to the acidic digestive juice can be suppressed, and it becomes easy to maintain the backflow prevention function of the first valve portion 17 for a long period of time.
  • the body fluid recirculation device 1D uses, for example, a material having physical characteristics suitable for a check valve regardless of acid resistance for the inner first valve portion 17, and the first valve portion 18 on the outer side.
  • a material having a higher acid resistance than that of the valve portion 17 can be used. As a result, it is possible to secure acid resistance and improve the backflow prevention function of the body fluid recirculation device 1D as a whole.
  • the coating portion 12 is formed of a material having acid resistance, but the coating portion 12 is merely an example and is not limited to this.
  • the capsule portion 12 does not necessarily have to have acid resistance.
  • the film portion 12 attached to the outer peripheral side of the skeleton portion 11 is exemplified, but the present invention is not limited to this, and is not limited to this, for example, the skeleton. It may be attached to the inner peripheral side of the portion 11.
  • the body fluid recirculation devices 1, 1A, 1B, 1C, and 1D those provided with the inflow assisting unit 14 are exemplified, but the present invention is not limited to this.
  • the body fluid when the body fluid is placed in the abdominal cavity 3 where a relatively large amount of body fluid is placed, the body fluid can sufficiently flow into the main body portion 10 from the second end portion 10b, so that it is not always necessary to provide the inflow assisting portion 14. do not have.
  • Body fluid recirculation device 2 ... Abdominal organ, 2a ... Wall, 2b ... Opening, 3 ... Skeleton, 10 ... Main body, 10a ... First end, 10b ... Second end, 11 ... Skeleton part, 11a ... Extension part, 12 ... Coating part, 13 ... Valve part, 13a ... Tapered part, 13b ... Flat part, 13c ... Outlet, 14 ... Inflow assisting part, 14a ... Through hole, 15 ... Opening Part, 16 ... Porous film, 17 ... First valve part, 18 ... Second valve part, 20 ... First locking part (positioning part), 21 ... Skeleton part, 22 ... Cover, 30, 30A, 30B ... second locking part (positioning part), 31 ... skeleton part, 32 ... cover

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Une partie corps principal tubulaire (10) d'un dispositif de recirculation de liquide (1) a une première partie d'extrémité (10a) qui est disposée à l'intérieur d'un organe de cavité abdominale (2) et une seconde partie d'extrémité (10b) qui est disposée à l'intérieur de la cavité abdominale (3). La première partie d'extrémité est pourvue d'une valve (13) ayant une sortie de liquide (13c) du côté aval dans le sens d'écoulement d'un liquide. Le dispositif de recirculation de liquide (1) distribue un liquide, qui se trouve à l'intérieur de la cavité abdominale (3) et qui s'écoule dans la seconde partie d'extrémité, à partir de la sortie (13c) de la valve, de manière à faire recirculer le liquide dans l'organe de cavité abdominale (2).
PCT/JP2021/033165 2020-09-23 2021-09-09 Dispositif de recirculation de liquide WO2022065058A1 (fr)

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JP2020-158497 2020-09-23
JP2020158497 2020-09-23

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024048540A1 (fr) * 2022-08-31 2024-03-07 日本ゼオン株式会社 Dispositif de reflux de fluide corporel

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003190274A (ja) * 2001-12-28 2003-07-08 Nippon Zeon Co Ltd 医療用チューブの製造方法
JP2006507018A (ja) * 2002-02-25 2006-03-02 ダニエル アール. バーネット, 過剰流体の排液のための小嚢シャント
US20140012180A1 (en) * 2012-05-01 2014-01-09 Nidus Medical, Llc Peritoneal drain and infusion
US9656049B1 (en) * 2012-09-06 2017-05-23 Mubashir H. Khan Subcutaneous fluid pump
WO2018071373A1 (fr) * 2016-10-10 2018-04-19 Kassab Ghassan S Dispositifs et procédés pour traiter une insuffisance cardiaque congestive, une ascite, et d'autres troubles liés à un excès de fluide corporel

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003190274A (ja) * 2001-12-28 2003-07-08 Nippon Zeon Co Ltd 医療用チューブの製造方法
JP2006507018A (ja) * 2002-02-25 2006-03-02 ダニエル アール. バーネット, 過剰流体の排液のための小嚢シャント
US20140012180A1 (en) * 2012-05-01 2014-01-09 Nidus Medical, Llc Peritoneal drain and infusion
US9656049B1 (en) * 2012-09-06 2017-05-23 Mubashir H. Khan Subcutaneous fluid pump
WO2018071373A1 (fr) * 2016-10-10 2018-04-19 Kassab Ghassan S Dispositifs et procédés pour traiter une insuffisance cardiaque congestive, une ascite, et d'autres troubles liés à un excès de fluide corporel

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024048540A1 (fr) * 2022-08-31 2024-03-07 日本ゼオン株式会社 Dispositif de reflux de fluide corporel

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