WO2020196887A1 - 医療デバイス - Google Patents

医療デバイス Download PDF

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Publication number
WO2020196887A1
WO2020196887A1 PCT/JP2020/014298 JP2020014298W WO2020196887A1 WO 2020196887 A1 WO2020196887 A1 WO 2020196887A1 JP 2020014298 W JP2020014298 W JP 2020014298W WO 2020196887 A1 WO2020196887 A1 WO 2020196887A1
Authority
WO
WIPO (PCT)
Prior art keywords
fusion promoting
fusion
sheet
pancreatic
medical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2020/014298
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
直希 荒巻
美穂 甲斐
杏梨 藤井
研介 内富
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2021509679A priority Critical patent/JP7386232B2/ja
Priority to EP20776921.7A priority patent/EP3932439A4/en
Priority to CN202080020780.XA priority patent/CN113573747B/zh
Publication of WO2020196887A1 publication Critical patent/WO2020196887A1/ja
Priority to US17/486,110 priority patent/US20220008073A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00884—Material properties enhancing wound closure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00951—Material properties adhesive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections

Definitions

  • the present invention relates to a medical device.
  • Patent Document 1 a method of suturing a living organ with a biodegradable suture and a mechanical joining device for anastomosis with a stapler.
  • Patent Document 1 A method using (see) has been proposed.
  • the bonding force between biological organs at the joint can be increased as compared with the method using sutures, which reduces the risk of suture failure. Will be possible.
  • the degree of progression of fusion at the junction also depends on the condition of the living tissue at the junction target site (joint site) of the patient. Therefore, for example, even when a joining device as described in Patent Document 1 is used, the risk of suture failure may not be sufficiently reduced depending on the condition of the patient's living tissue.
  • an object of the present invention is to provide a medical device capable of reducing the risk of suture failure after surgery or the like.
  • the medical device includes a fusion promoting sheet provided with a fusion promoting portion for promoting fusion of living tissues, and a holding portion capable of hooking and holding the fusion promoting sheet on a biological organ to be joined.
  • the medical device it is possible to promote the fusion of the biological tissue of the biological organ by sandwiching the fusion promoting sheet between the bonded sites of the biological organ to be joined.
  • the operator can hook and hold the fusion promoting sheet on a part of the biological organ to be joined by the holding portion. Therefore, the surgeon can prevent the fusion promoting sheet from falling off from the living organ during the procedure. Therefore, the risk of suture failure of living organs can be effectively reduced.
  • FIG. 1A It is a perspective view which shows one form of the medical device of this invention. It is a figure for demonstrating the use example of the medical device of FIG. 1A. It is sectional drawing which shows the part of the cross section along the line 2A-2A of FIG. 1A enlarged. It is a perspective view which shows the modification 1 of the medical device of this invention. It is a figure for demonstrating the use example of the medical device of FIG. 3A. It is a perspective view which shows the modification 2 of the medical device of this invention. It is a figure for demonstrating the use example of the medical device of FIG. 4A. It is a figure for demonstrating the modification 3 of the medical device of this invention. It is a flowchart which shows each procedure of the treatment method using a medical device.
  • FIG. 6 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis.
  • FIG. 1A is a perspective view showing one form of the medical device 100.
  • FIG. 1B is a diagram showing a usage example of the medical device 100 of FIG. 1A, and is a front view of the cut surface B1a of the pancreatic parenchyma B1.
  • FIG. 2 is an enlarged cross-sectional view showing a part of the cross section taken along the line 2A-2A of FIG. 1A.
  • the medical device 100 hooks and holds the fusion promoting sheet 110 arranged between the biological organs to be joined and the fusion promoting sheet 110 on the biological organ (pancreatic parenchyma B1) to be joined. It has a holding portion 120 that enables it.
  • the medical device 100 can be applied to a procedure for joining predetermined biological organs (for example, gastrointestinal anastomosis).
  • predetermined biological organs for example, gastrointestinal anastomosis
  • pancreatic parenchymal-jejunal anastomosis will be described as an example of a procedure using the medical device 100.
  • the fusion promoting sheet 110 has a fusion promoting portion 110A that promotes the fusion of living tissue formed from a biodegradable sheet having a plurality of through holes 112.
  • the fusion promoting portion 110A is formed in a predetermined range including the central portion C in the plane direction of the fusion promoting sheet 110.
  • the fusion promoting sheet 110 has a frame portion 110B provided on the outer side of the fusion promoting sheet 110 in the surface direction with respect to the fusion promoting portion 110A.
  • the frame portion 110B is formed in a certain range including the outer peripheral edge O of the fusion promotion sheet 110 so as to surround the periphery of the fusion promotion portion 110A.
  • the frame portion 110B is not formed with a through hole 112.
  • the through holes 112 formed in the fusion promoting portion 110A are regularly and periodically provided in the plane direction of the fusion promoting sheet 110.
  • each through hole 112 may be randomly provided at each portion in the surface direction of the fusion promoting sheet 110.
  • each through hole 112 extends substantially vertically between the front surface 113 and the back surface 114 along the thickness direction of the fusion promoting sheet 110 (vertical direction in FIG. 2).
  • each through hole 112 may be bent or curved in a zigzag shape between the front surface 113 and the back surface 114 in the cross section along the thickness direction of the fusion promoting sheet 110.
  • Each through hole 112 has a substantially circular planar shape (shape when the front surface 113 of the fusion promotion sheet 110 or the back surface 114 of the fusion promotion sheet 110 is viewed in a plan view).
  • the planar shape of each through hole 112 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.). Further, the plane shape and the cross-sectional shape may be different for each through hole 112.
  • the fusion promoting sheet 110 has a substantially circular planar shape.
  • the planar shape of the fusion promoting sheet 110 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.).
  • the thickness of the fusion promoting sheet 110 is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.
  • the fusion promoting portion 110A can be provided with such strength that the fusion promoting portion 110A is not damaged when the fusion promoting sheet 110 is handled.
  • the thickness of the fusion promoting sheet 110 is 0.3 mm or less (particularly when it is 0.2 mm or less)
  • the fusion promoting portion 110A adheres to the living tissue to which the fusion promoting sheet 110 is applied and follows the living tissue. It can be flexible enough to do so.
  • the fusion promoting portion 110A is the ratio of the hole diameter D (distance D shown in FIG. 2) of the through hole 112 to the pitch P (distance P shown in FIG. 2 and the distance between adjacent through holes 112) of the through hole 112.
  • the value is preferably 0.25 or more and less than 40.
  • the hole diameter D of the through hole 112 is equal to the diameter of the perfect circle.
  • the diameter of a perfect circle having the same area as the area of the opening of the through hole 112 (the portion of the through hole 112 facing the front surface 113 or the back surface 114) ( The equivalent circle diameter) can be the hole diameter D of the through hole 112.
  • the fusion promoting unit 110A has a plurality of through holes 112, there are a plurality of values of the hole diameter D corresponding to each through hole 112. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the hole diameter D values corresponding to the plurality of through holes 112 is used as the representative value of the hole diameter D. ..
  • the pitch P of the plurality of through holes 112 is defined by the shortest distance between the openings of the two through holes 112. However, as for the value of the pitch P, there are a plurality of values of the pitch P corresponding to the combination of the adjacent through holes 112. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the pitch P values corresponding to the combinations of the adjacent through holes 112 is used as the representative value of the pitch P. And.
  • the pitch P, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like of the through hole 112 are merely examples, and are not limited thereto.
  • the fusion promoting unit 110A can be made of a biodegradable material.
  • the constituent material of the fusion promoting unit 110A is not particularly limited, and examples thereof include biodegradable resins.
  • biodegradable resin for example, those described in Japanese Patent Publication No. 2011-528275, Japanese Patent Publication No. 2008-514719, International Publication No. 2008-1952, Japanese Patent Publication No. 2004-509205 and the like are known.
  • Biodegradable (co) polymers can be used.
  • the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose.
  • Polymer; (2) A copolymer composed of one or more monomers constituting the above (1) and the like can be mentioned.
  • the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses. It preferably contains at least one biodegradable resin selected from the group consisting of a polymer and a copolymer composed of one or more monomers constituting the polymer.
  • the method for producing the fusion promoting unit 110A is not particularly limited, and examples thereof include a method for producing a fiber made of the above-mentioned biodegradable resin and producing a mesh-shaped sheet using the fiber.
  • the method for producing the fiber made of a biodegradable resin is not particularly limited, and examples thereof include an electrospinning method (electrospinning method / electrostatic spinning method) and a melt blow method.
  • electrospinning method electrospinning method / electrostatic spinning method
  • melt blow method melt blow method.
  • the fibers made of the above-mentioned biodegradable resin are spun according to a conventional method, and the obtained fibers are knitted into a mesh shape to obtain the biodegradable property according to the present invention. Sheets may be manufactured.
  • the fusion promoting unit 110A induces a biological reaction by a constituent material such as a biodegradable resin constituting the fusion promoting unit 110A.
  • the fusion promoting unit 110A induces the expression of biological components such as fibrin by this action.
  • the biological components induced in this way can promote fusion by accumulating so as to penetrate through the through hole 112 of the fusion promoting portion 110A. Therefore, by arranging the fusion promoting portion 110A between the biological organs to be joined, the fusion is promoted by the above mechanism.
  • the material of the fusion promoting unit 110A does not have to be biodegradable as long as it can promote the fusion of biological organs. Further, the fusion promoting unit 110A may not have the through hole 112 formed regardless of the material, as long as it can promote the fusion of living organs.
  • the frame portion 110B is formed on the fusion promoting sheet 110 so as to surround the fusion promoting portion 110A.
  • the frame portion 110B is preferably formed to have a higher rigidity than the fusion promoting portion 110A so that the frame portion 110B is not easily deformed when an external force is applied.
  • the frame portion 110B can be made of, for example, a biodegradable sheet in which a hole such as a through hole 112 is not formed, a resin sheet having a higher rigidity than the fusion promoting portion 110A, or a non-woven fabric.
  • the fusion promoting sheet 110 may be provided with the frame portion 110B by not forming the through hole 112 in a certain region including the outer peripheral edge O of the biodegradable sheet which is a constituent material of the fusion promoting portion 110A. Further, after forming a through hole 112 in a certain region including the outer peripheral edge O of the biodegradable sheet which is a constituent material of the fusion promoting portion 110A, only the region is compressed or heated in the thickness direction to penetrate. By crushing the holes 112, a portion in which the constituent materials of the biodegradable sheet are densely assembled may be formed, and the portion may be used as the frame portion 110B.
  • the frame portion 110B may be provided with an inhibitory portion that suppresses adhesion with a biological organ at least in a part thereof.
  • the material constituting the suppressing portion is not particularly limited as long as it can suppress adhesion with a living organ, but for example, a non-woven fabric can be used.
  • the suppressing portion can be made of a biodegradable material, similarly to the fusion promoting portion 110A.
  • the fusion promotion sheet 110 may be composed of the fusion promotion unit 110A as a whole. That is, the fusion promotion sheet 110 may not be provided with the frame portion 110B.
  • a holding portion 120 is arranged on the frame portion 110B of the fusion promoting sheet 110.
  • the holding portion 120 has one end portion 121a, the other end portion 121b, and an intermediate portion 122 extending between the one end portion 121a and the other end portion 121b.
  • the holding portion 120 has a substantially C-shaped planar shape.
  • the holding portion 120 is arranged only in a part along the circumferential direction of the fusion promoting sheet 110.
  • the holding portion 120 is integrally attached to the fusion promoting sheet 110.
  • the holding portion 120 can be arranged and fixed, for example, inside the front surface 113, the back surface 114, or the fusion promotion sheet 110 of the fusion promotion sheet 110. Fixing can be configured, for example, by integrally molding the holding portion 120 at the time of molding the adhesive or the fusion promoting sheet 110.
  • the holding portion 120 can be configured to hold the fusion promoting sheet 110 against the pancreatic parenchyma B1 by elastic force.
  • the material constituting the holding portion 120 is not particularly limited, but may be composed of, for example, a superelastic alloy such as an alloy of titanium and nickel. However, other metal materials or resin materials that can impart elastic force may be used.
  • the holding portion 120 may be configured to be separable from, for example, the fusion promoting sheet 110.
  • the holding portion 120 is attached from the outer surface side of the fusion promoting sheet 110 in a state where the fusion promoting sheet 110 is arranged so as to cover a part of the pancreatic parenchyma B1, thereby promoting the fusion by the holding portion 120.
  • the sheet 110 can be held against the pancreatic parenchyma B1.
  • the shape and size of the holding portion 120, the position to be attached to the fusion promoting sheet 110, and the like are not particularly limited.
  • the medical device 100 has a traction portion 140 that enables a traction operation of the fusion promoting sheet 110 toward a side facing the position where the holding portion 120 is arranged.
  • the "side facing the position where the holding portion 120 is arranged" is a position facing the fusion promoting sheet 110 with the central portion C in between.
  • the traction portion 140 can be composed of a string-shaped member or a band-shaped member connected to the fusion promoting sheet 110.
  • the band-shaped member has a certain width, and examples thereof include a member having a long side and a short side formed in a cross-sectional shape.
  • a string-shaped member having a predetermined length is connected to the frame portion 110B.
  • FIG. 1A shows a form in which a part of the traction portion 140 is arranged close to the holding portion 120, the specific arrangement form of the traction portion 140 is not particularly limited.
  • the traction portion 140 is a thermoplastic elastomer such as vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), or nylon. , PET or other thermoplastic resin, or rubber, silicone elastomer, fiber material, SUS wire, copper wire, titanium wire, nitinol wire or other metal. Further, the traction portion 140 can be made of, for example, the same material as the fusion promoting portion 110A. By using the same material as the fusion promoting unit 110A, it becomes possible to manufacture at the same manufacturing site as the fusion promoting unit 110A, so that the manufacturing operation becomes easy.
  • the installation of the towing unit 140 may be omitted. Further, the position where the traction portion 140 is arranged on the fusion promotion sheet 110 is not particularly limited. Further, the length, cross-sectional shape, thickness, number of installations, and the like of the tow portion 140 are not particularly limited.
  • FIG. 1B shows a front view (front view seen from the cut surface B1a side of the pancreatic parenchyma B1) when the fusion promoting sheet 110 is hooked and held by the holding portion 120 on the pancreatic parenchyma B1.
  • the operator can, for example, arrange the holding portion 120 so as to hook it on the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal portion of the pancreatic parenchyma B1 in the circumferential direction).
  • the fusion promoting portion 110A can be held against the pancreatic parenchyma B1 while preventing wrinkles and the like from occurring on the fusion promoting sheet 110.
  • the holding portion 120 is made of a material capable of imparting elastic force
  • the fusion promoting sheet 110 is more reliably prevented from falling off. It becomes possible to do.
  • the operator can stretch the fusion promoting sheet 110 by pulling the traction portion 140 on the anterior wall B1d (the ventral portion of the pancreatic parenchyma B1 in the circumferential direction) side of the pancreatic parenchyma B1. This makes it possible to prevent wrinkles from occurring on the fusion promoting sheet 110.
  • the operator can traction the traction portion 140 with respect to the fusion promoting sheet 110 even when the operator releases the fingers from the traction portion 140. It becomes possible to maintain the state in which.
  • the medical device 100 holds the fusion promoting sheet 110 provided with the fusion promoting unit 110A for promoting the fusion of biological tissues by hooking the fusion promoting sheet 110 on the biological organ to be joined. It has a holding portion 120 that enables it.
  • the fusion of the biological tissues of the biological organs can be promoted by sandwiching the fusion promoting sheet 110 between the bonded sites of the biological organs to be joined. ..
  • the operator can hook and hold the fusion promoting sheet 110 on a part of the biological organ (for example, pancreatic parenchyma B1) to be joined by the holding portion 120. Therefore, the surgeon can prevent the union promotion sheet 110 from falling off from the living organ during the procedure. Therefore, the risk of suture failure of living organs can be effectively reduced.
  • the holding portion 120 is configured to be able to hold the fusion promoting sheet 110 with respect to a living organ by elastic force. Therefore, the operator can more reliably hold the fusion promoting sheet 110 to the living organ by the elastic force of the holding portion 120.
  • the holding portion 120 is integrally attached to the fusion promoting sheet 110. Therefore, it is possible to prevent the holding portion 120 from being separated from the fusion promoting sheet 110, and it is possible to maintain the state in which the fusion promoting sheet 110 is held with respect to the living organ more stably.
  • the holding portion 120 is arranged only in a part along the circumferential direction of the fusion promoting sheet 110. Therefore, by arranging the holding portion 120 so as to be hooked on a part of the outer peripheral surface of the biological organ (for example, a part of the posterior wall B1c of the pancreatic parenchyma B1), wrinkles or the like may occur on the fusion promoting sheet 110. While preventing it, the fusion promoting unit 110A can be appropriately arranged in the living organ.
  • the medical device 100 has a traction unit 140 that enables a traction operation of the fusion promotion sheet 110 toward the side facing the position where the holding unit 120 is arranged. Therefore, the operator can more reliably prevent wrinkles from being generated on the fusion promoting sheet 110 by pulling the traction portion 140.
  • the traction portion 140 can be composed of a string-shaped member or a band-shaped member connected to the fusion promoting sheet 110.
  • the operator can prevent the fusion promoting sheet 110 from being wrinkled by pulling the traction portion 140 by grasping it with fingers or the like.
  • the frame portion 110B can prevent the frame portion 110B from adhering to a biological organ other than the biological organ to be joined by the suppressing portion that suppresses the adhesion to the biological organ.
  • FIG. 3A is a perspective view of the medical device 200 according to the modified example 1
  • FIG. 3B is a diagram for explaining a usage example of the medical device 200 according to the modified example 1.
  • the holding portion 220 does not have to be composed of, for example, one continuous member.
  • the holding portion 220 is divided into three parts 221 in the arrangement direction of the holding portion 220 (circumferential direction of the fusion promoting sheet 110). It is composed of 222 and 223.
  • the holding portion 220 according to the first modification exhibits a function of holding the fusion promoting sheet 110 against the living organ, similarly to the holding portion 120 according to the above-described embodiment.
  • the holding portion 220 is composed of a plurality of divided pieces, the number of divided pieces, the length, shape, material, etc. of each divided piece are not particularly limited.
  • FIG. 4A is a perspective view of the medical device 300 according to the modified example 2
  • FIG. 4B is a diagram for explaining a usage example of the medical device 300 according to the modified example 2.
  • the traction unit 340 may be composed of, for example, a part of the fusion promotion sheet 110.
  • the traction portion 340 is formed by a convex portion on which a part of the fusion promoting sheet 110 protrudes. As shown in FIG. 4B, when the fusion promoting sheet 110 is held against the pancreatic parenchyma B1, the traction portion 340 is lifted to the side facing the side where the holding portion 120 is provided (upper side in the drawing) to promote fusion. It is possible to prevent the sheet 110 from being wrinkled.
  • the specific shape, size, number, etc. of the towed portion 340 are not particularly limited.
  • FIG. 5 is a diagram for explaining a usage example of the medical device according to the modified example 3.
  • the shape of the holding portion 420 is different from that of the holding portion 120 of the above-described embodiment.
  • the holding portion 420 is arranged so as to come into contact with the pancreatic parenchyma B1 (indirect contact with the fusion promoting sheet 110 sandwiched between them) when hooked on the pancreatic parenchyma B1. It has one site 422a and a plurality of second sites 422b arranged with a gap between the pancreatic parenchyma B1.
  • the first portion 422a and the second portion 422b are alternately arranged in the circumferential direction of the fusion promoting sheet 110.
  • the holding portion 420 can have a smaller area in contact with the pancreatic parenchyma B1 as compared with the holding portion 120 formed in the C shape (see FIG. 1B) described above. Therefore, it is possible to reduce the burden on the patient while holding the fusion promoting sheet 110 on the pancreatic parenchyma B1 by the holding portion 420.
  • FIG. 6 is a flowchart showing each procedure of the treatment method using the medical device.
  • the treatment method includes preparing a medical device including a fusion promoting sheet provided with a holding portion (S11), arranging the fusion promoting sheet on one of the joined sites (S12), and hooking the holding portion on the joined site. (S13), fixing the fusion promoting sheet to one of the joined sites (S14), and placing at least a part of the fusion promoting sheet between one joined site and the other joined site. Includes joining (S15) between the joined portion of the above and the other joined portion.
  • the living organ to be joined by the treatment method and the joining site in the living organ are not particularly limited and can be arbitrarily selected.
  • pancreatic parenchymal-jejunal anastomosis will be described as an example.
  • the above-mentioned treatment method may be applied to colon anastomosis or gastric tube anastomosis.
  • any of the above-mentioned medical devices can be selected.
  • a usage example of a specific medical device will be described as a typical example that can be suitably used for each procedure.
  • detailed description of known procedure procedures, known medical devices, medical instruments, etc. will be omitted as appropriate.
  • arranging the fusion promoting sheet between the living organs means that the fusion promoting sheet is arranged in a state of being in direct or indirect contact with the living organ, and the living organ
  • the fusion-promoting sheet is placed with a spatial gap formed between the two, or the fusion-promoting sheet is placed in both states (for example, the fusion-promoting sheet comes into contact with one of the biological organs).
  • the fusion promoting sheet is placed in contact with the other living organ).
  • the term "periphery” does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (bonding between biological organs) can be achieved. Means.
  • the order of the procedure procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved.
  • FIG. 7 is a flowchart showing the procedure of the embodiment of the treatment method (pancreatic parenchymal-jejunal anastomosis), and FIGS. 8 to 15 are diagrams used for explaining the pancreatic parenchymal-jejunal anastomosis.
  • the biological organs to be joined are the pancreatic parenchyma B1 after pancreaticoduodenectomy and the jejunum B2.
  • a procedure for joining the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 (one joined site) and an arbitrary site of the intestinal wall of the jejunum B2 (the other joined site) will be described. Further, in the present embodiment, an example of using the medical device 100 shown in FIG. 1A will be described.
  • the treatment method according to the present embodiment is to prepare a medical device 100 including a fusion promoting sheet 110 provided with a holding portion 120 (S101), and to cut the fusion promoting sheet 110 into the pancreatic parenchyma B1.
  • a medical device 100 including a fusion promoting sheet 110 provided with a holding portion 120 (S101), and to cut the fusion promoting sheet 110 into the pancreatic parenchyma B1.
  • the promotion sheet 110 is sandwiched (S105), the fusion promotion sheet 110 is sandwiched between the pancreatic parenchyma B1 and the jejunum B2 (S106), and the fusion promotion sheet 110 is placed between the pancreatic parenchyma B1 and the jejunum B2. To do (S107).
  • FIG. 13 a plurality of needles at both ends 920a to 920e, which will be described later, are omitted.
  • the operator makes the back surface 114 (or surface 113) of the fusion promoting sheet 110 face the cut surface B1a of the pancreatic parenchyma B1.
  • the operator arranges the holding portion 120 so as to be on the outer side of the cut surface B1a in the surface direction.
  • the operator arranges the holding portion 120 so as to be hooked on the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal portion in the circumferential direction of the pancreatic parenchyma B1), thereby causing the fusion promoting sheet 110 with respect to the pancreatic parenchyma B1.
  • the fusion promotion portion 110A can be brought into close contact with the cut surface B1a of the pancreatic parenchyma B1 while preventing wrinkles from occurring on the fusion promotion sheet 110 (see FIG. 1B).
  • the operator When arranging the fusion promotion sheet 110 on the cut surface B1a of the pancreatic parenchyma B1, the operator can adopt the following work procedure. First, the operator forms a hole 130 in the fusion promoting sheet 110 by pressing the end 911 (or end 912) of the pancreatic duct tube 910 against the fusion promoting sheet 110. In addition, the operator performed the pancreatic duct tube so that the end 911 of the pancreatic duct tube 910 passes through the inside of the jejunum B2 through the through hole B2a of the planned anastomosis site of the jejunum B2 and exits from the through hole B2b of the jejunum B2 to the outside of the jejunum B2. 910 is inserted into jejunum B2.
  • the operator temporarily inserts the end portion 912 of the pancreatic duct tube 910 into the pancreatic duct B1b of the pancreatic parenchyma B1 while the pancreatic duct tube 910 inserts the hole 130 of the fusion promoting sheet 110 and holds the fusion promoting sheet 110. To do.
  • pancreatic duct tube 910 for example, a known resin tube having a bump (convex portion) formed at the end portion 912 to prevent removal can be used.
  • the pancreatic duct tube 910 temporarily inserted into the pancreatic duct B1b suppresses the leakage of body fluid such as pancreatic juice from the pancreatic duct B1b during the procedure. According to such a procedure, the operator can arrange the fusion promoting sheet 110 and temporarily insert the pancreatic duct tube 910 at the same time.
  • the operator may use a device other than the pancreatic duct tube 910 when forming the hole 130 for inserting the pancreatic duct tube 910.
  • the hole 130 through which the pancreatic duct tube 910 is inserted may be formed in the fusion promoting sheet 110 in advance in a state before use.
  • the operator may temporarily insert the pancreatic duct tube 910 into the pancreatic duct B1b after arranging the fusion promoting sheet 110 on the cut surface B1a of the pancreatic parenchyma B1.
  • the operator fixes the fusion promoting sheet 110 to the pancreatic parenchyma B1 with a fixing member.
  • a procedure for fixing the fusion promoting sheet 110 to the pancreatic parenchyma B1 by using a plurality of both end needles 920a to 920e with sutures as fixing members will be described.
  • known needles having a bioabsorbable absorbent thread (suture) and a biocompatible needle portion attached to both ends of the absorbent thread can be used.
  • the needles 930 and 940a to 940e at both ends which will be described later, are also configured to include an absorbent thread and a needle portion.
  • the operator holds the fusion promoting sheet 110 against the pancreatic parenchyma B1 and holds the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal portion of the pancreatic parenchyma B1 in the circumferential direction) and Both ends needles 920a are moved from the portion of the fusion promoting sheet 110 arranged on the posterior wall B1c toward the anterior wall B1d of the pancreatic parenchyma B1 and the portion of the fusion promoting sheet 110 arranged on the anterior wall B1d.
  • the operator moves both ends of the needle 920a so as to insert the jejunal serosal muscular layer at the planned anastomosis site of the jejunum B2 (around the through hole B2a).
  • the operator repeats such an operation, and as shown in FIG. 10, a plurality of both ends needles 920a to 920e on the jejunal serosal muscular layer of the fusion promoting sheet 110, the pancreatic parenchyma B1, and the jejunum B2, and a plurality of both ends needles 920a to The 920e is inserted.
  • the operator can fix the fusion promoting sheet 110 to the pancreatic parenchyma B1 by using a plurality of both end needles 920a to 920e that suture the pancreatic parenchyma B1 and the jejunum B2.
  • the surgeon may interrupt the holding by the holding portion 120 and the traction operation by the traction portion 140.
  • the holding portion 120 and the traction portion 140 may be appropriately separated from the fusion promoting sheet 110 by cutting off a part of the fusion promoting sheet 110.
  • the operator performs holding by the holding portion 120 and traction by the traction portion 140 until the fusion promoting sheet 110 is fixed to the cut surface B1a of the pancreatic parenchyma B1, so that the fusion promoting sheet 110 cuts the pancreatic parenchyma B1. It is possible to prevent the surface B1a from being displaced and wrinkles from being generated on the fusion promoting sheet 110.
  • the number of both-end needles to be inserted into the serosal muscular layer of the jejunum parenchyma B1 and jejunum B2 and the position to insert the both-end needles are not particularly limited. Further, the operator may fix the fusion promoting sheet 110 to the pancreatic parenchyma B1 by using biodegradable staples or the like as a fixing member instead of the plurality of needles 920a to 920e at both ends.
  • the operator passes the needles 930 at both ends from the lumen side of the pancreatic duct B1b toward the anterior wall B1d side of the cut surface B1a of the pancreatic parenchyma B1.
  • the needles 930 at both ends are held by a gripping instrument such as tweezers (not shown) so as not to interfere with the procedure in a state where the jejunum B2 is not inserted.
  • the operator moves one end of the needles 940a at both ends from the lumen side of the pancreatic duct B1b toward the cut surface B1a of the pancreatic parenchyma B1.
  • the operator inserts the other end of the needles 940a at both ends into the through hole B2a of the jejunum B2, and the needles 940a at both ends toward the outside of the jejunum B2 from the inside of the jejunum B2. Move the other end.
  • FIG. 10 and 12 the operator moves one end of the needles 940a at both ends from the lumen side of the pancreatic duct B1b toward the cut surface B1a of the pancreatic parenchyma B1.
  • FIG. 12 is a cross-sectional view schematically showing a part of the pancreatic parenchyma B1 and the jejunum B2 before being anastomosed.
  • the operator brings the posterior wall B1c of the pancreatic parenchyma B1 and the pancreatic duct B1b into close contact with the planned anastomosis site of the jejunum B2. Then, of the plurality of needles 940a to 940e at both ends, the needles 940c to 940e at both ends that insert the dorsal side (rear wall B1c side) of the pancreatic duct B1b in the circumferential direction are ligated.
  • the operator reinserts the end 912 of the pancreatic duct tube 910 into the pancreatic duct B1b, as shown in FIG.
  • the operator inserts the needle portion 931 extending from the inside of the pancreatic duct B1b in the needles 930 at both ends into the through hole B2b formed in the jejunum B2, and moves the needle portion 931 from the inside of the jejunum B2 toward the outside of the jejunum B2.
  • the operator ligates the needles 930, 940a, and 940b at both ends (not shown).
  • the number of both-end needles to be inserted into the pancreatic duct B1b and the jejunum B2 and the position to insert the both-end needles are not particularly limited.
  • the operator ligates the needles 920a to 920e at both ends while pressing the jejunum B2 against the pancreatic parenchyma B1 with the operator's finger.
  • the pancreatic parenchyma B1 and the jejunum B2 are sutured with the fusion promoting sheet 110 sandwiched between them.
  • the jejunum B2 is deformed by the tension generated at the time of suturing so as to enclose the cut surface B1a of the pancreatic parenchyma B1 and the fusion promoting portion 110A of the fusion promoting sheet 110.
  • the operator places the fusion promoting sheet 110 in a state where the fusion promoting portion 110A of the fusion promoting sheet 110 is sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2.
  • the fusion promoting portion 110A of the fusion promoting sheet 110 is placed between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 while being in contact with the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. This promotes the fusion of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2.
  • the treatment method according to the present embodiment is applied to the procedure for joining the pancreatic parenchyma B1 and the jejunum B2. Further, in the above treatment method, the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 and the intestinal wall (jejunal serosal muscular layer) of the jejunum B2 are joined. According to this treatment method, the biological tissue of the pancreatic parenchyma B1 and the living body of the intestinal wall of the jejunum B2 are formed by the fusion promoting portion 110A of the fusion promoting sheet 110 sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. Tissue fusion can be promoted and the risk of suture failure after pancreatic parenchymal-jejunostomy can be reduced.
  • the holding portion 120 by holding the fusion promoting sheet 110 against the pancreatic parenchyma B1 by the holding portion 120, it is possible to prevent the fusion promoting sheet 110 from being displaced or dropped from the pancreatic parenchyma B1 during the procedure. Further, by pulling the traction portion 140 to apply a traction force to the fusion promoting sheet 110, it is possible to hold the fusion promoting sheet 110 against the pancreatic parenchyma B1 while preventing wrinkles from occurring on the fusion promoting sheet 110. It will be possible.

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PCT/JP2020/014298 2019-03-28 2020-03-27 医療デバイス Ceased WO2020196887A1 (ja)

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JP2021509679A JP7386232B2 (ja) 2019-03-28 2020-03-27 医療デバイス
EP20776921.7A EP3932439A4 (en) 2019-03-28 2020-03-27 Medical device
CN202080020780.XA CN113573747B (zh) 2019-03-28 2020-03-27 医疗器具
US17/486,110 US20220008073A1 (en) 2019-03-28 2021-09-27 Medical device

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EP3932439A4 (en) 2022-04-27
JP7386232B2 (ja) 2023-11-24
CN113573747A (zh) 2021-10-29
EP3932439A1 (en) 2022-01-05
CN113573747B (zh) 2023-02-24
JPWO2020196887A1 (https=) 2020-10-01

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