WO2021060361A1 - Dispositif favorisant la fusion - Google Patents

Dispositif favorisant la fusion Download PDF

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Publication number
WO2021060361A1
WO2021060361A1 PCT/JP2020/035988 JP2020035988W WO2021060361A1 WO 2021060361 A1 WO2021060361 A1 WO 2021060361A1 JP 2020035988 W JP2020035988 W JP 2020035988W WO 2021060361 A1 WO2021060361 A1 WO 2021060361A1
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WIPO (PCT)
Prior art keywords
joined
magnetic
engaging device
main body
engaging
Prior art date
Application number
PCT/JP2020/035988
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English (en)
Japanese (ja)
Inventor
直希 荒巻
美穂 甲斐
美利亜 鈴木
Original Assignee
テルモ株式会社
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
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Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2021548976A priority Critical patent/JP7498188B2/ja
Publication of WO2021060361A1 publication Critical patent/WO2021060361A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • the present invention relates to a fusion promoting device.
  • Various methods and medical instruments are used in the technique of joining living organs.
  • a method of suturing a living organ with a biodegradable suture or a mechanical anastomosis device for anastomosis with a stapler see Patent Document 1.
  • the method of using is proposed.
  • the joint 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 biological 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 fusion promoting device capable of reducing the risk of suture failure after surgery or the like.
  • the fusion promoting device joins a first joined portion in a living tissue and a second joined portion facing the first joined portion, and joins the first joined portion or the second joined portion.
  • a medical device provided with an engaging device capable of contacting with and to which a first magnetic portion containing a magnetic material can be attached
  • a biological tissue is formed.
  • the main body portion that promotes the fusion of the above and the main body portion are arranged between the first joined portion and the second joined portion, and the engaging device is placed at the first joined portion or the second joined portion.
  • a second magnetic portion that is provided at a position facing the first magnetic portion in the surface direction of the main body portion and can be brought into close contact with the first magnetic portion by the magnetic force received from the first magnetic portion. And have.
  • the risk of suture failure after surgery or the like can be reduced.
  • FIG. 3 is a perspective view showing a tip of a first engaging instrument and a second engaging instrument constituting the medical device according to FIG. 1. It is a perspective view which shows the state which the fusion promotion device is inserted through the shaft of the 2nd engaging device which constitutes a medical device. It is a side view of FIG. It is sectional drawing which shows the through hole in the fusion promotion device of FIG. It is a flowchart which shows each procedure of the treatment method using a fusion promotion device. It is a flowchart which shows the procedure of embodiment (colon anastomosis) of a treatment method.
  • FIG. 5 is a cross-sectional view showing a through hole 11 of the fusion promoting device 100.
  • 6 to 11 are views for explaining the case of performing gastrointestinal anastomosis using the large intestine as an example using the fusion promoting device 100.
  • the fusion promoting device 100 and the medical device 200 can be collectively referred to as a medical device set.
  • the fusion promoting device 100 can be applied to a procedure for joining predetermined biological organs (for example, gastrointestinal anastomosis) as shown in FIGS. 8 to 11.
  • predetermined biological organs for example, gastrointestinal anastomosis
  • FIGS. 8 to 11 As will be described later, in the description of the present specification, the large intestine anastomosis technique will be described as an example of the procedure using the fusion promoting device 100, but the site where the fusion promoting device according to the present invention can be used is not limited to the large intestine.
  • the fusion promoting device 100 is used when the first jointed portion such as the large intestine and the second joined portion are joined by the medical device 200.
  • the medical device 200 will be described.
  • the medical device 200 joins a first joined portion in a living tissue and a second joined portion facing the first joined portion.
  • the medical device 200 includes a first engaging device 210 and a second engaging device 270 capable of sandwiching the main body portion 10 through the first joined portion and the second joined portion.
  • the first engaging instrument 210 can be brought into contact with the first joined portion, and the second engaging instrument 270 is configured to be able to come into contact with the second joined portion. Details will be described later.
  • the first engaging device 210 may be referred to as a trocar and the second engaging device 270 may be referred to as an anvil.
  • the first engaging device 210 includes a long member 220, a positioning unit 230, a discharging unit 240, a punching unit 250, and an operating unit 260.
  • the long member 220 corresponds to the main body of the first engaging device 210. As shown in FIG. 2, the long member 220 includes a space S in which the shaft of the positioning portion 230 can be relatively moved back and forth at the tip in the longitudinal direction.
  • the longitudinal direction at the tip of the long member 220 is defined as the direction X.
  • the long member 220 has a hollow circular cross section intersecting the direction X.
  • the long member 220 extends linearly in the longitudinal direction and has a bent portion. However, if the anastomosis function and the punching function described later can be realized, the long member does not have a bent portion. May be good.
  • the positioning unit 230 includes a long shaft. As shown in FIG. 2, the shaft of the positioning portion 230 is configured to be relatively movable back and forth from the space S at the tip of the long member 220 in the longitudinal direction.
  • the discharge unit 240 is configured to be capable of releasing a plurality of staples that join the first bonded portion and the second bonded portion.
  • the discharge portion 240 is formed in a substantially disk shape on the tip end side in the longitudinal direction of the long member 220.
  • the discharge unit 240 is configured by providing a plurality of staple discharge points along the circumferential direction ⁇ at the tip of the long member 220.
  • the plane direction intersecting the longitudinal direction at the tip of the long member 220 is defined as the direction YZ
  • the radial direction or the radial direction is defined as the radial direction r
  • the circumferential direction or the angular direction is defined as the circumferential direction ⁇ .
  • the punching portion 250 is arranged at the tip of the long member 220 inward in the radial direction r than the discharging portion 240, and is configured to punch inward in the radial direction of the first bonded portion and the second bonded portion. There is. As shown in FIG. 2, the punching portion 250 is configured to include an annular blade that punches out the first bonded portion and the second bonded portion inward in the radial direction r than the discharging portion 240.
  • the operation unit 260 is configured so that the positioning unit 230, the discharge unit 240, and the punching unit 250 can be operated.
  • the operation unit 260 includes a rotating unit 261 and a handle 262.
  • the rotating portion 261 is provided at the proximal end portion (base end side) of the long member 220 in the longitudinal direction.
  • the rotating portion 261 is configured to be rotatable with respect to the long member 220 with the longitudinal direction on the base end side of the long member 220 as the rotation axis.
  • the rotating portion 261 is rotated with respect to the long member 220 to form the first engaging tool 210 and the second engaging tool 270. Is configured so that they can be relatively close and separated.
  • the handle 262 is configured to be grippable by the user together with the base end portion (base end side) of the long member 220.
  • the handle 262 is rotatably connected to the elongated member 220 by a rotating shaft 263.
  • the handle 262 rotates around the rotating shaft 263 and comes relatively close to the elongated member 220 when gripped by the user. As a result, the staples are discharged from the discharging portion 240, and the annular blade of the punching portion 250 can be projected from the tip of the long member 220.
  • the second engaging device 270 is configured so that the main body 10 of the fusion promoting device 100 can be sandwiched between the first joined portion and the second joined portion. As shown in FIG. 3, the second engaging device 270 includes a head 280, a contact portion 290, a first magnetic portion 310, and a shaft 320.
  • the head 280 is arranged adjacent to the long member 220 of the first engaging device 210, particularly on the tip end side, when the first engaging device 210 and the second engaging device 270 are engaged with each other.
  • the head 280 is configured to have a substantially disk shape as shown in FIGS. 2 and 3, and the cross-sectional shape is configured to be the same as or similar to the circular shape of the long member 220.
  • the contact portion 290 is configured to be able to contact a plurality of staples discharged from the discharge portion 240.
  • the contact portion 290 is provided on the side of the first engaging device 210 in the axial direction of the head 280 (the plate thickness direction, see the direction X in FIG. 3).
  • the contact portion 290 is configured so as to be able to contact a plurality of staples discharged from the discharge portion 240.
  • the staples released from the discharging portion 240 are brought into contact with each other at the contacting portion 290 and deformed to join the first bonded portion and the second bonded portion.
  • the first magnetic portion 310 is configured to be attracted by a magnetic force to the second magnetic portion 20 provided in the main body portion 10 of the fusion promoting device 100. As a result, the first magnetic portion 310 and the second magnetic portion 20 are configured to be in close contact with each other.
  • the first magnetic portion 310 is configured to be attached to the head 280 and integrated with the head 280 on the side of the contact portion 290, which is the side of the first engaging device 210 in the plate thickness direction (direction X) of the head 280. are doing.
  • the first magnetic portion 310 is formed in a disk shape so that the outer diameter d1 of the first magnetic portion 310 is smaller than the inner diameter d2 of the contact portion 290.
  • the first magnetic portion 310 includes a magnetic material such as a hard magnetic material constituting a permanent magnet. The magnetic material is not particularly limited, and examples thereof include iron, cobalt, nickel, samarium, and neodymium.
  • the shaft 320 is provided to engage the first engaging device 210 and the second engaging device 270.
  • the shaft 320 is configured to extend axially from the side of the first engaging device 210 in the axial direction (direction X) of the head 280.
  • the shaft 320 has a circular cross section perpendicular to the longitudinal direction in the present embodiment.
  • the shaft 320 is provided with a space for accommodating the shaft of the positioning portion 230 of the first engaging device 210.
  • the shaft 320 is configured to fit the shaft of the positioning portion 230, which enables the alignment of the first engaging instrument 210 and the second engaging instrument 270.
  • the fusion promoting device 100 includes a main body portion 10, a second magnetic portion 20, a reinforcing portion 30, and a hole portion 40.
  • the main body portion 10 promotes fusion of the living tissue when joining the first joined portion in the living tissue and the second joining site facing the first joined site.
  • the main body 10 includes a plurality of through holes 11 formed so as to be inserted in the thickness direction (direction X) as shown in FIGS. 3 and 5.
  • the size of the through hole 11 of the main body 10 is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.
  • the main body 10 can be configured such that the ratio of the dimension D of the through hole 11 to the pitch P is 0.2 or more and less than 40.
  • the main body 10 can be made of a biodegradable material.
  • the constituent material of the main body 10 is not particularly limited, and examples thereof include biodegradable resins.
  • polystyrene resin is selected from the group consisting of (1) aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, 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 second magnetic portion 20 is brought into contact with the first bonded portion and the second bonded portion. It is provided at a position facing the first magnetic portion 310 in the surface direction (direction YZ) of the main body portion 10.
  • the second magnetic portion 20 is configured to be in close contact with the first magnetic portion 310 by the magnetic force received from the first magnetic portion 310.
  • the second magnetic portion 20 is formed in a flat substantially disk shape in the present embodiment.
  • the second magnetic portion 20 is configured to include a soft magnetic material such as iron that can be magnetized by the first magnetic portion 310 including a permanent magnet in the present embodiment.
  • the first magnetic part 310 may be made of a soft magnetic material and the second magnetic part 20 may be made of a hard magnetic material as long as the first magnetic part 310 and the second magnetic part 20 can be brought into close contact with each other.
  • both the first magnetic portion 310 and the second magnetic portion 20 may be made of a hard magnetic material such as a permanent magnet.
  • the reinforcing portion 30 is provided to prevent the fusion promoting device 100 from being damaged when the fusion promoting device 100 is placed between the first bonded portion and the second bonded portion by the medical device 200.
  • the reinforcing portion 30 is configured such that the through hole 11 like the main body portion 10 is not provided on the outer circumference of the hollow substantially circular shape.
  • the specific shape and arrangement are not limited to the above.
  • the hole 40 is configured to be insertable into the shaft 320 of the medical device 200.
  • the hole 40 has a substantially circular shape when viewed from the axial direction in the present embodiment.
  • the fusion promoting device 100 and the medical device 200 are configured so that the following relationship is established (see FIGS. 2 and 3).
  • d3 is the outer diameter of the punched portion 250 of the medical device 200
  • d4 is the outer diameter of the reinforcing portion 30 provided on the outer periphery of the main body portion 10 in the fusion promoting device 100
  • d5 is the inner diameter of the second magnetic portion 20 provided on the inner circumference of the main body portion 10
  • d6 is the outer diameter of the shaft 320 of the medical device 200. That is, the outer diameter d3 of the punched portion 250 is configured to be larger than the sum of the outer diameter d4 of the main body portion 10 and the inner diameter d5 of the main body portion 10 minus the outer diameter d6 of the shaft 320. ..
  • the manufacturing method of the main body 10 is not particularly limited.
  • fibers containing the above-mentioned biodegradable material are arranged in a circumferential shape, and similar fibers are arranged in a radial direction to form a circumferential fiber and a radial fiber.
  • a method of integrating with the fiber is conceivable.
  • the method for producing the fiber made of biodegradable resin include an electrospinning method (electrospinning method / electrostatic spinning method) and a melt blow method.
  • electrospinning method electrospinning method / electrostatic spinning method
  • melt blow method for the main body 10 only one of the above methods may be selected, or two or more thereof may be appropriately combined.
  • the main body 10 induces a biological reaction by a constituent material such as a biodegradable resin constituting the main body 10.
  • the main body 10 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 11 of the main body 10. Therefore, by arranging the main body 10 of the fusion promoting device 100 between the biological organs to be joined, the fusion is promoted by the above mechanism.
  • FIG. 8 is a schematic cross-sectional perspective view for explaining colorectal anastomosis.
  • the treatment method is a fusion promoting device 100 provided with a sheet-shaped main body 10 that promotes fusion of biological tissues between one first bonded site and the other second bonded site to be bonded to a biological organ. Includes placement (S11).
  • the treatment method is that at least a part of the main body 10 of the fusion promoting device 100 is arranged between one first bonded site and the other second bonded site, and one first bonded site and the other It includes joining with the second jointed portion (S12).
  • 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.
  • colon anastomosis will be described as an example.
  • arranging a fusion promoting device between living organs means that the healing promoting device is in direct or indirect contact with the living organ. It can mean that it is placed.
  • the above description may mean that the fusion promoting device is arranged in a state where a spatial gap is formed between the living organ and the living organ. Further, in the above description, the fusion promoting device is arranged in both states (for example, the fusion promoting device is in contact with one biological organ and the fusion promoting device is not in contact with the other biological organ). To be done) can mean.
  • peripheral 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 biological organ to be joined is the large intestine that has been cut due to the excision of the cancer tumor.
  • the biological organs to be joined are the oral side A2 of the cut large intestine and the anal side A1 of the cut large intestine.
  • the procedure for joining the area around the mouth of the mouth side A2 of the cut large intestine (second joint site) and a part of the intestinal wall of the anal side A1 of the cut large intestine (first joint site) will be described. explain.
  • the treatment method according to the present embodiment is to dispose the fusion promoting device 100 between the mouth of the large intestine and the intestinal wall of the large intestine (S101), the mouth of the large intestine and the intestine of the large intestine. Includes making the walls relatively close (S102).
  • the treatment method is to sandwich the main body 10 of the fusion promoting device 100 between the periphery of the mouth of the large intestine and the intestinal wall of the large intestine (S103), and the fusion promoting device between the periphery of the mouth of the large intestine and the intestinal wall of the large intestine. This includes joining (S104) with the main body 10 sandwiched between 100. The details will be described below.
  • the operator inserts the second engaging instrument 270 of the medical instrument 200 into the oral side A2 of the large intestine.
  • the surgeon places the first engaging device 210 of the medical device 200 on the anal side A1 of the large intestine.
  • a through hole A11 is formed on the anal side A1 of the large intestine.
  • the timing of forming the through hole A11 is not particularly limited as long as it is before the first engaging device 210 is arranged.
  • the surgeon inserts the shaft 320 of the second engaging instrument 270 into the oral side A2 of the large intestine and sutures the shaft 320 with a drawstring in a protruding state to form the sutured portion A21.
  • the outer surface of the sewn portion A21 has a shape that partially protrudes to the convex side as the sewn portion A21 is sewn.
  • the operator places the fusion promoting device 100 between the oral side A2 of the large intestine and the anal side A1 of the large intestine (S101).
  • the operator passes the shaft 320 included in the second engaging instrument 270 through the hole 40 formed in the main body 10 as shown in FIG.
  • the main body 10 is deformed so that the inside of the main body 10 in the radial direction r is raised as shown in FIG. 9 in accordance with the shape of the sutured portion A21 formed so as to be raised in the living body.
  • the operator engages the shaft of the positioning portion 230 and the shaft 320 of the second engaging instrument 270 at a position separated from each other while maintaining the state in which the main body portion 10 is held with respect to the oral side A2 of the large intestine.
  • the rotating portion 261 is rotated so that the first engaging instrument 210 and the second engaging instrument 270 are relatively close to each other as shown in FIG.
  • the periphery of the mouth of the large intestine and the intestinal wall of the large intestine are relatively close to each other (S102).
  • the surgeon between the first engaging instrument 210 and the second engaging instrument 270, is located around the mouth of the oral side A2 of the large intestine, the main body 10 of the fusion promoting device 100, and the anal side A1 of the large intestine.
  • the periphery of the through hole A11 formed in the intestinal wall is sandwiched (S103).
  • the surgeon rotates the handle 262 of the operation unit 260 of the medical device 200 around the rotation shaft 263 to project the annular blade of the punching unit 250. Then, a part of the oral side A2 of the large intestine sandwiched between the first engaging device 210 and the second engaging device 270, the second magnetic part 20 of the main body portion 10, and a part of the anal side A1 of the large intestine. Is excised, and the periphery of the excised site is joined by staples (not shown) (S104).
  • the surgeon takes out the medical device 200 from, for example, the anal side A1 of the large intestine to the outside of the living body via the anus.
  • the region formed inward from the outer diameter d3 of the punched portion 250 of the first engaging instrument 210 is taken out of the living body together with the medical instrument 200.
  • the second magnetic portion 20 located inward in the radial direction r than the punched portion 250 is removed without remaining in the body.
  • a joining technique for example, gastrointestinal anastomosis
  • a simple method of sandwiching the sheet-shaped main body portion 10 between the first joined portion and the second joined portion is performed by a simple method of sandwiching the sheet-shaped main body portion 10 between the first joined portion and the second joined portion. It is possible to reduce the risk of subsequent suture failure.
  • the fusion promoting device 100 is used when joining the first joined portion and the second joined portion by the medical device 200.
  • the medical device 200 is a magnetic material capable of joining a first bonded portion and a second bonded portion facing the first bonded portion and contacting the first bonded portion or the second bonded portion.
  • a second engaging device 270 to which the first magnetic portion 310 including the above can be attached is provided.
  • the fusion promoting device 100 has a main body portion 10 and a second magnetic portion 20. The main body 10 promotes the fusion of living tissues when the first jointed portion and the second joined portion are joined by the medical device 200.
  • the main body portion 10 is arranged between the first bonded portion and the second bonded portion, and the second engaging instrument 270 is in contact with the first bonded portion or the second bonded portion. It is provided at a position facing the first magnetic portion 310 in the surface direction of the main body portion 10 when the main body portion 10 is formed.
  • the second magnetic portion 20 is configured to be in close contact with the first magnetic portion 310 by the magnetic force received from the first magnetic portion 310.
  • the main body of the fusion promotion device is usually soft and easily twisted or misaligned.
  • the main body of the fusion promoting device tends to have a weak force to adhere to living tissues such as the intestinal tract, and is likely to fall off.
  • by providing the fusion promoting device 100 with a second magnetic portion 20 that can be brought into close contact with the first magnetic portion 310 of the medical device 200 it is possible to prevent or suppress misalignment with the medical device 200 that may cause dropping or the like. Can be done.
  • the risk of suture failure after surgery or the like can be reduced.
  • the medical device 200 includes a first engaging device 210 and a second engaging device 270 capable of sandwiching the main body portion 10 via the first joined portion and the second joined portion.
  • the second engaging instrument 270 includes a plate-shaped head 280, and the first magnetic portion 310 is attached to the head 280 so as to be integrated.
  • the first engaging device 210 includes a discharging portion 240 and a punching portion 250.
  • the discharge portion 240 is formed in a disk shape, and is configured to be capable of releasing a plurality of staples that join the first bonded portion and the second bonded portion.
  • the punching portion 250 is configured to punch in the radial direction of the first bonded portion and the second bonded portion and to be arranged inward in the radial direction r than the discharging portion 240.
  • the second engaging device 270 is provided on the side of the first engaging device 210 in the axial direction of the head 280, and includes a contact portion 290 capable of contacting a plurality of staples discharged from the discharging portion 240.
  • the first magnetic portion 310 is provided on the side of the abutting portion 290 in the axial direction of the second engaging device 270, and is configured such that the outer diameter d1 is smaller than the inner diameter d2 of the abutting portion 290.
  • the contact portion 290 has the same diameter as the discharge portion 240 and is close to the diameter of the punched portion 250. Therefore, by configuring as described above, even if there is a radial r gap between the hole 40 of the fusion promoting device 100 and the shaft 320 of the second engaging device 270, the second engaging device 270 It is possible to prevent the fusion promoting device 100 from being displaced with respect to the above.
  • the outer diameter of the second magnetic portion 20 is smaller than the outer diameter d1 of the first magnetic portion 310, the risk of the second magnetic portion 20 being displaced outward from the punched portion 250 is reduced.
  • the second magnetic portion 20 can be removed from the body by the punching portion 250.
  • the first engaging device 210 includes a punched portion 250 formed in an annular shape by punching the inner side of the first joined portion and the second joined portion in the radial direction r.
  • the second engaging device 270 includes a long shaft 320 provided on one side of the head 280 in the axial direction and having a circular cross section.
  • the main body 10 includes a hole 40 through which the shaft 320 can be inserted.
  • the outer diameter d3 of the punched portion 250 is configured to be larger than the sum of the outer diameter d4 of the main body portion 10 and the inner diameter d5 of the main body portion 10 minus the outer diameter d6 of the shaft 320.
  • the second engagement device 100 is second.
  • the magnetic portion 20 can be punched out and removed from the living tissue.
  • At least one of the first magnetic part 310 and the second magnetic part 20 is configured to contain a hard magnetic material. As a result, even if the other is not a hard magnetic material, the two can be attracted to each other and brought into close contact with each other so that they can be aligned with each other.
  • FIG. 12 is a side view showing a second engaging device 270a of the medical device according to the modified example of the first embodiment.
  • the first magnetic portion 310 is provided on the side of the contact portion 290 in the head 280, but it can also be configured as follows.
  • the fusion promoting device and the first engaging device of the medical device are the same as those in the first embodiment, and thus the description thereof will be omitted.
  • the medical device including the second engaging device 270a and the fusion promoting device 100 can be combined to form a medical device set.
  • the first magnetic portion 310a is provided on the side opposite to the contact portion 290 in the plate thickness direction of the head 280 (see direction X in FIG. 12) as shown in FIG. 12 in this modified example. ..
  • the outer diameter d7 of the first magnetic portion 310a is configured to be larger than the outer diameter d3 (see FIG. 2) of the punching portion 250. Since other configurations and treatment methods in the second engaging device 270a are the same as those in the first embodiment, the description thereof will be omitted.
  • the first engaging device 210 includes a discharging portion 240 and a punching portion 250 as in the first embodiment.
  • the discharge unit 240 is arranged in a disk shape, and is configured to be capable of releasing a plurality of staples that join the first bonded portion and the second bonded portion.
  • the punching portion 250 punches inward in the radial direction of the first bonded portion and the second bonded portion, and is arranged inward in the radial direction r than the discharging portion 240.
  • the second engaging device 270a is provided on the side of the first engaging device 210 in the axial direction of the head 280 as in the first embodiment, and is in contact with a plurality of staples discharged from the discharge unit 240.
  • a unit 290 is provided.
  • the first magnetic portion 310a is provided on the side opposite to the contact portion 290 in the axial direction of the second engaging tool 270a, and is configured such that the outer diameter d7 is larger than the outer diameter d3 of the punching portion 250. Even with this configuration, the first magnetic portion 310a and the second magnetic portion 20 can prevent or suppress the misalignment between the fusion promoting device 100 and the medical device 200 so as not to cause the above-mentioned dropout or the like. ..
  • FIG. 13 and 14 are perspective views showing a fusion promoting device 100 and a second engaging device 270b of a medical device according to a second embodiment of the present invention.
  • the medical device set can be configured by combining the fusion promoting device 100 and the medical device including the second engaging device 270b.
  • the first magnetic portion 310 is attached to the head 280 of the second engaging device 270 and is integrated, but it can also be configured as follows. Since the first engaging device and the fusion promoting device 100 of the medical device are the same as those of the first embodiment, the description thereof will be omitted. Further, since the second engaging instrument 270b is the same as the second engaging instrument 270 of the first embodiment except that it does not include the first magnetic portion, the description thereof will be omitted.
  • the reinforcing member 400 is used for positioning the medical device and the fusion promoting device.
  • the reinforcing member 400 is configured as a separate component from the first engaging device 210 and the second engaging device 270b.
  • the reinforcing member 400 includes a reinforcing portion 410, a mounting portion 420, a first magnetic portion 430, and a hole portion 440.
  • the reinforcing portion 410 provides a through hole 11 of a fusion promoting device 100 through which a body fluid such as blood flowing through the lumen of a living tissue passes through a staple or the like at a first jointed portion and a second bonded portion joined by a medical device. It is provided to prevent it from leaking to the outside.
  • the reinforcing portion 410 is provided between the mounting portion 420 and the first magnetic portion 430 in the radial direction r.
  • the reinforcing portion 410 can be configured in the same manner as the portion provided with the through hole 11 of the fusion promoting device 100.
  • the reinforcing portion 410 reinforces the resistance to leakage of body fluid or the like from the main body portion 10 by providing a portion similar to the portion of the through hole 11 of the main body portion 10 as described above.
  • the mounting portion 420 is configured so that the reinforcing member 400 can be mounted on the second engaging device 270b on the outer side in the radial direction r. As shown in FIG. 13, the mounting portion 420 is partially provided on the outer periphery of the reinforcing portion 410 in the present embodiment. In the present embodiment, the mounting portion 420 has a plurality of substantially triangular shapes having vertices facing outward in the radial direction r arranged on the outer periphery of the reinforcing portion 410.
  • the medical device 200 is rotated in the circumferential direction ⁇ with respect to the reinforcing member 400 in a state where the reinforcing member 400 is attached to the second engaging device 270b, the reinforcing portion 410, the first magnetic portion 430, and the mounting portion 420 are formed. And separate.
  • the second engaging instrument 270b and the fusion promoting device 100 are aligned at the time of joining the first joined portion and the second joined portion, and the reinforcement is prevented from leaking from the needle hole after joining.
  • the portion 410 can be placed at the joint site together with the fusion promoting device 100.
  • the first magnetic part 430 is configured in a ring shape like the first magnetic part 310 in the first embodiment, and the first magnetic part 430 corresponds to the ring part. Therefore, detailed description will be omitted.
  • the hole 440 is provided to attach the reinforcing member 400 to the medical device 200b.
  • the hole 440 is configured to be inserted into the shaft 320 of the second engaging device 270b in the present embodiment.
  • the hole 440 is configured to have a diameter similar to the outer diameter of the shaft 320 in the present embodiment, but the specific dimensional relationship is not limited to the above as long as the reinforcing member 400 can be attached to the medical device 200b.
  • the treatment method according to the present embodiment will be described.
  • the operator inserts the hole 440 of the reinforcing member 400 into the shaft 320 of the second engaging instrument 270b.
  • the mounting portion 420 of the reinforcing member 400 is attached to the head 280 of the second engaging device 270b to integrate the reinforcing member 400 with the second engaging device 270b.
  • the fusion promoting device 100 is arranged between the oral side A2 of the large intestine and the anal side A1 of the large intestine (S101).
  • the operator passes the shaft 320 included in the second engaging instrument 270b through the hole 40 formed in the main body 10.
  • the operator engages the shaft of the positioning portion 230 and the shaft 320 of the second engaging instrument 270b at a position separated from each other while maintaining the state in which the main body portion 10 is held with respect to the oral side A2 of the large intestine.
  • the rotating portion 261 is rotated so that the first engaging instrument 210 and the second engaging instrument 270 are relatively close to each other as shown in FIG.
  • the periphery of the mouth of the large intestine and the intestinal wall of the large intestine are relatively close to each other (S102).
  • the operator rotates the handle 262 of the operation portion 260 of the first engaging tool 210 around the rotation shaft 263 to project the annular blade of the punching portion 250. Then, a part of the oral side A2 of the large intestine sandwiched between the first engaging device 210 and the second engaging device 270b, the first magnetic portion 430 of the reinforcing member 400, and the second magnetic portion 20 of the main body portion 10. , And a part of the anal side A1 of the large intestine is excised. Then, the periphery of the excised portion is joined by staples (not shown) (S104).
  • the surgeon takes out the medical device including the first engaging device 210 and the second engaging device 270b from, for example, the anal side A1 of the large intestine to the outside of the living body via the anus.
  • the region formed inward from the outer diameter d3 of the punched portion 250 of the first engaging device 210 of the medical device is taken out of the living body together with the medical device.
  • the portion of the reinforcing portion 410 of the reinforcing member 400 outside the outer diameter d3 of the punched portion 250 and the portion of the through hole 11 of the main body portion 10 of the fusion promoting device 100 are between the first bonded portion and the second bonded portion. It is detained while being sandwiched between them.
  • the first engaging instrument 210 is formed in an annular shape by punching the inner side of the first joined portion and the second joined portion in the radial direction r as in the first embodiment.
  • a punching portion 250 is provided.
  • the second engaging device 270b includes a long shaft 320 provided on the side of the first engaging device 210 in the axial direction of the head 280.
  • the main body 10 includes a hole 40 that can be inserted into the shaft 320.
  • the first magnetic portion 430 is provided on the reinforcing member 400, which is a separate component from the first engaging device 210 and the second engaging device 270b.
  • the reinforcing member 400 provided with the first magnetic portion 430 is attached to the second engaging device 270b.
  • the reinforcing member 400 provided with the first magnetic portion 430 is configured to have a ring shape facing the second magnetic portion 20 of the main body portion 10 when the hole portion 440 is inserted through the shaft 320.
  • the reinforcing member 400 is provided between the mounting portion 420 that can be attached to the second engaging device 270b in the radial direction r and the ring shape of the first magnetic portion 430 and the mounting portion 420 in the radial direction r.
  • a reinforcing portion 410 is provided to reinforce the main body portion 10.
  • the mounting portion 420 is configured to be partially provided on the outer periphery of the reinforcing portion 410.
  • the reinforcing member 400 can be fixed to the second engaging device 270b until the first joined portion and the second joined portion are joined. Then, by separating the reinforcing portion 410 from the mounting portion 420 after joining, the reinforcing portion 410 that prevents leakage from the staple portion at the joining portion can be placed in the living body.
  • the present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims.
  • the shaft 320 of the second engaging device 270 of the medical device 200 is inserted into the suture portion A21 and inserted into the hole 40 of the fusion promoting device 100, the inside of the main body portion 10 in the radial direction r.
  • the sewn portion A21 is deformed so as to be raised according to the shape of the sewn portion A21.
  • the shape of the main body 10 in the radial direction r is not limited to this, and the shape of the product itself is similar to the shape of the stitched portion A21 in the radial direction r even if it is not adjacent to the stitched portion A21.
  • a shape that rises in the longitudinal direction (direction X) may be provided.
  • the alignment with the sutured portion A21 becomes easy, and the fusion promoting device 100 can be prevented from falling off when the first bonded portion and the second bonded portion are joined by that amount.
  • the present invention is not limited to the above, and a convex portion may be added to the disk shape of the first magnetic portion, and a concave portion corresponding to the convex portion of the first magnetic portion may be provided in the second magnetic portion.
  • the first engaging device or the second engaging device constituting the medical device can be easily aligned with the fusion promoting device, and the fusion promoting device can be prevented from falling off at the time of joining.
  • the present invention is not limited to this.
  • the case where the reinforcing member is attached to the first engaging device and integrated is also included in one embodiment of the present invention. Even in such a case, the mounting portion is separated from the reinforcing portion by integrating the reinforcing member with the first engaging device and rotating the medical device in the circumferential direction ⁇ with the reinforcing member arranged at the joint portion in the same manner as described above. To do. As a result, a reinforcing portion that prevents leakage from the staple portion can be placed at the joint portion.
  • 100 fusion promotion device 10 Main body, 20 Second magnetic part, 40 holes, 200 medical devices, 210 First Engagement Device, 240 discharge part, 250 punching part, 270, 270a, 270b second engaging device, 280 heads, 310, 310a, 430 1st magnetic part, d1, d7 outer diameter (outer diameter of the first magnetic part), d2 inner diameter (inner diameter of contact part), d3 outer diameter (outer diameter of punched part) d4 outer diameter (outer diameter of the main body), d5 inner diameter (inner diameter of the main body), d6 outer diameter (shaft outer diameter), r radial direction (radiation direction), ⁇ Circumferential direction (angle direction).

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Afin de fournir un dispositif favorisant la fusion grâce auquel le risque d'insuffisance suturale après une opération chirurgicale ou similaire peut être réduit, la présente invention est configurée de façon à avoir : une partie de corps (10) pour favoriser la fusion d'un tissu biologique lorsqu'une première partie à joindre dans le tissu biologique et une seconde partie à joindre, qui fait face à la première partie à joindre, sont reliées par un instrument médical (200) comprenant un instrument de couplage (210, 270) qui relie la première partie à joindre et la seconde partie à joindre et auquel peut être fixée une première partie magnétique (310) qui comprend un matériau magnétique et qui peut entrer en contact avec la première partie à joindre ou la seconde partie à joindre ; et une seconde partie magnétique (20) qui est disposée dans une position faisant face à la première partie magnétique dans la direction de surface de la partie de corps lorsque la partie de corps est disposée entre la première partie à joindre et la seconde partie à joindre, et l'instrument de couplage est placé en contact avec la première partie à joindre ou la seconde partie à joindre, et qui est capable d'adhérer à la première partie magnétique par une force magnétique reçue en provenance de la première partie magnétique.
PCT/JP2020/035988 2019-09-25 2020-09-24 Dispositif favorisant la fusion WO2021060361A1 (fr)

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JP2019-174342 2019-09-25

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007505708A (ja) * 2003-09-17 2007-03-15 ゴア エンタープライズ ホールディングス，インコーポレイティド 円形ステープラーのバットレス
JP2014208260A (ja) * 2008-08-05 2014-11-06 コヴィディエン リミテッドパートナーシップ 磁気圧縮吻合デバイス
WO2019156230A1 (fr) * 2018-02-08 2019-08-15 テルモ株式会社 Appareil médical et dispositif favorisant l'adhérence l'utilisant

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007505708A (ja) * 2003-09-17 2007-03-15 ゴア エンタープライズ ホールディングス，インコーポレイティド 円形ステープラーのバットレス
JP2014208260A (ja) * 2008-08-05 2014-11-06 コヴィディエン リミテッドパートナーシップ 磁気圧縮吻合デバイス
WO2019156230A1 (fr) * 2018-02-08 2019-08-15 テルモ株式会社 Appareil médical et dispositif favorisant l'adhérence l'utilisant

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JP7498188B2 (ja) 2024-06-11

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