WO2023189202A1 - Élément médical - Google Patents

Élément médical Download PDF

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Publication number
WO2023189202A1
WO2023189202A1 PCT/JP2023/007988 JP2023007988W WO2023189202A1 WO 2023189202 A1 WO2023189202 A1 WO 2023189202A1 JP 2023007988 W JP2023007988 W JP 2023007988W WO 2023189202 A1 WO2023189202 A1 WO 2023189202A1
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WO
WIPO (PCT)
Prior art keywords
main body
buffer
medical
medical member
section
Prior art date
Application number
PCT/JP2023/007988
Other languages
English (en)
Japanese (ja)
Inventor
直希 荒巻
美朱帆 白石
昭宏 高橋
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
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023189202A1 publication Critical patent/WO2023189202A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis

Definitions

  • the present invention relates to medical components.
  • Various methods and medical instruments are used to anastomose living organs, such as methods for suturing living organs with biodegradable sutures, and mechanical anastomosis devices that perform anastomosis using a stapler (see Patent Document 1).
  • a method using In particular, when performing anastomosis using a mechanical anastomosis device, it is possible to increase the joining force between living organs at the junction compared to methods using sutures, which reduces the risk of suture failure. becomes possible.
  • a sheet-like member such as a support structure (hereinafter referred to as a medical member) is inserted to promote healing at the anastomosis site.
  • a medical member such as a support structure
  • Such medical devices are typically relatively thin and soft.
  • the present inventors have focused on the fact that when the above-mentioned medical member is used to anastomose the gastrointestinal tract or the like, the medical member may become distorted due to external force applied thereto. If the medical member is distorted, the effect of promoting healing at the anastomosis site may be affected.
  • the present invention has been made to solve the above-mentioned problems, and it is possible to prevent twisting of the medical member due to external force applied when performing anastomosis using a sheet-like medical member at the anastomosis site.
  • the purpose is to prevent or suppress.
  • One aspect of the present invention is a medical member that includes a main body portion and a buffer portion.
  • the main body part can be placed at an anastomotic part of a biological organ, and at least a portion thereof includes a bioabsorbable material and is configured in a sheet shape.
  • the buffer section has a space inside thereof, and the space of the buffer section is configured to be surrounded by a buffer member constituting the omnidirectional buffer section in a cross section intersecting the circumferential direction of the main body.
  • one aspect of the present invention includes the above-mentioned main body, and the main body, which is provided so as to cover at least a part of the outer surface of the main body, and whose cross section intersecting the circumferential direction of the main body has a polygonal shape other than a rectangle. ing.
  • the medical member according to one aspect of the present invention it is possible to prevent or suppress twisting of the medical member due to external force being applied when anastomosis is performed using a sheet-like medical member at the anastomosis site.
  • FIG. 1 is a schematic perspective view showing a medical member according to a first embodiment.
  • 2 is a plan view showing the medical member according to FIG. 1.
  • FIG. FIG. 2 is a cross-sectional view of the medical member according to FIG. 1 taken along the axial direction, cut through the center of the main body. It is a figure which shows the through-hole of the main body part in a medical member.
  • FIG. 2 is a diagram showing a medical instrument used for anastomosis of medical members.
  • FIG. 3 is a diagram showing a state in which a medical member and a living organ are sandwiched between a first engagement instrument and a second engagement instrument.
  • FIG. 3 is a diagram illustrating how living organs are anastomosed.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to modification 1 of the first embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 , showing a medical member according to a second modification of the first embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to a third modification of the first embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to a fourth modification of the first embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to a second embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to Modification 1 of the second embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to a second modification of the second embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to a third modification of the second embodiment.
  • FIG. 4 is a sectional view corresponding to FIG. 3 and showing a medical member according to a third modification of the second embodiment.
  • FIG. 3 is a plan view corresponding to FIG. 2 and showing a medical member according to a third embodiment.
  • FIG. 3 is a plan view corresponding to FIG. 2 , showing a medical member according to Modification 1 of the third embodiment.
  • FIG. 3 is a plan view corresponding to FIG. 2 and showing a medical member according to a second modification of the third embodiment.
  • FIG. 3 is a plan view corresponding to FIG. 2 , showing a medical member according to modification 3 of the third embodiment.
  • It is a top view which shows the medical member based on 4th Embodiment, and corresponds to FIG. 25 is a side view showing the medical member according to FIG. 24.
  • FIG. It is a sectional view corresponding to FIG. 3 and showing a medical member according to a fifth embodiment.
  • FIG. 4 is a cross-sectional view corresponding to FIG. 3 and showing a modification of a medical member including a buffer section with a space.
  • X in the orthogonal coordinate system is along the axial direction or thickness direction of the main body portion 10 constituting the medical member 100, and is referred to as the axial direction X.
  • Y and Z are planes that intersect with the axial direction X, and are referred to as plane direction YZ.
  • r in the cylindrical coordinate system is a direction extending in the radial direction or radial direction from the center of the main body portion 10 etc. of the medical member 100 along the plane direction YZ, and is referred to as the radial direction r.
  • ⁇ is along the circumferential direction or angular direction of the main body 10 and the like in the plane direction YZ that intersects the axial direction X of the main body 10 and the like, and is referred to as the circumferential direction ⁇ .
  • FIG. 1 is a schematic perspective view showing a medical member 100 according to the first embodiment
  • FIG. 2 is a plan view showing the medical member 100
  • 3 is a cross-sectional view taken along the axial direction X passing through the center of the main body 10 of the medical member 100
  • FIG. 4 is a diagram showing the through hole 11 of the main body 10 of the medical member 100.
  • FIG. 5 is a diagram showing a medical instrument 200 used in a procedure using the medical member 100.
  • FIG. 6 is a diagram showing the distal end portion of the first engagement instrument 210 and the second engagement instrument 270 that constitute the medical instrument 200.
  • FIGS. 7 to 11 are diagrams illustrating a procedure for performing anastomosis of the gastrointestinal tract, using the large intestine as an example, using the medical member 100.
  • the medical member 100 can be applied to procedures for joining predetermined biological organs (for example, gastrointestinal anastomosis).
  • predetermined biological organs for example, gastrointestinal anastomosis
  • a colon anastomosis will be described as an example of a procedure using the medical member 100, but the region where the fusion promoting device according to the present invention can be used is not limited to the large intestine.
  • the medical device 200 joins one joined site (first joined site), which is a biological organ in a living tissue, and the other joined site (second joined site) opposite to the first joined site.
  • the medical instrument 200 includes a first engagement instrument 210 and a second engagement instrument 270 that are capable of sandwiching the medical member 100 through a first welded region and a second welded region.
  • Medical device 200 may be referred to as a circular stapler. The configuration of each part will be explained below.
  • the first engagement instrument 210 is placed on one side of the medical member 100 when the medical member 100 is anastomosed to a living tissue, as shown in FIG. 10 and the like.
  • the first engagement instrument 210 is configured to be able to come into contact with the first part to be joined.
  • the second engagement instrument 270 is arranged on the opposite side of the first engagement instrument 210 with respect to the medical member 100 at the time of anastomosis, and is configured to be able to come into contact with the second site to be joined. Details will be described later.
  • First engagement device 210 may be referred to as a trocar and second engagement device 270 may be referred to as an anvil. The details will be explained below.
  • the first engagement instrument 210 includes an elongated member 220, a positioning section 230, a discharge section 240, a punching section 250, and an operating section 260, as shown in FIGS. 5 and 6.
  • the elongated member 220 corresponds to the main body of the first engagement instrument 210. As shown in FIG. 6, the elongated member 220 includes a space S at its longitudinal end in which the shaft of the positioning section 230 can be moved relatively forward and backward.
  • the elongated member 220 has a hollow circular cross section that intersects with the axial direction.
  • the elongated member 220 extends linearly in the longitudinal direction and has a bent portion, but if the anastomosis function and punching function described below can be realized, the elongated member does not need to have a bent portion. Good too.
  • the positioning section 230 includes an elongated shaft. As shown in FIG. 6, the shaft of the positioning section 230 is configured to be able to move forward and backward relative to the space S at the distal end in the longitudinal direction of the elongated member 220.
  • the positioning portion 230 is configured to be insertable into a hole 30 that may be formed approximately at the center of the medical member 100 and into the inner cavity of a shaft 310 of a second engagement instrument 270, which will be described later.
  • the ejection unit 240 is configured to be able to eject a plurality of staples that join the first and second parts to be joined in a substantially annular shape.
  • the discharge portion 240 is formed in a substantially disk shape on the distal end side in the longitudinal direction of the elongated member 220.
  • the discharge portion 240 is configured by providing a plurality of staple discharge locations along the circumferential direction at the distal end of the elongated member 220.
  • the punching part 250 is arranged at the distal end of the elongated member 220 radially inward from the discharge part 240 and is configured to punch out the radially inward part of the first welded part and the second welded part. .
  • the punching section 250 is configured to include an annular blade that punches out the first welded part and the second welded part radially inward from the discharge part 240.
  • the shape of the punched portion 250 can be a perfect circle when viewed in plan from the longitudinal direction, but the shape of the punched portion 250 may be an ellipse or the like as long as it punches out a portion unnecessary for promoting healing.
  • the operating section 260 is configured to be able to operate the positioning section 230, the ejection section 240, and the punching section 250.
  • the operating section 260 includes a rotating section 261 and a handle 262, as shown in FIG.
  • the rotating part 261 is provided at the proximal end (base end side) of the elongated member 220 in the longitudinal direction.
  • the rotating portion 261 is configured to be rotatable relative to the elongated member 220 with the longitudinal direction of the proximal end of the elongated member 220 as a rotation axis.
  • the rotating part 261 rotates the first engagement instrument 210 and the second engagement instrument 270 with respect to the elongated member 220 in a state where the second engagement instrument 270 is engaged with the first engagement instrument 210.
  • the structure is such that they can be moved relatively close to each other and separated from each other.
  • the handle 262 is configured to be graspable by the user together with the proximal end (base end side) of the elongated member 220.
  • the handle 262 is rotatably connected to the elongated member 220 by a rotating shaft 263.
  • the handle 262 When the handle 262 is gripped by the user, it rotates around the rotation axis 263 and relatively approaches the elongated member 220 . Thereby, the staple is ejected from the ejection part 240, and the annular blade of the punching part 250 can be protruded from the tip of the elongated member 220.
  • the second engagement instrument 270 is configured to be able to sandwich the medical member 100 together with the first engagement instrument 210 via the first and second regions to be joined.
  • the second engagement device 270 includes a head 280, an abutment portion 290, and a shaft 310, as shown in FIG.
  • the head 280 is disposed adjacent to the elongated member 220 of the first engagement instrument 210, particularly on the distal end side, when the first engagement instrument 210 and the second engagement instrument 270 are engaged.
  • the head 280 has a substantially disk shape as shown in FIGS. 5 and 6, and has a cross-sectional shape that is the same as or similar to the circular shape of the elongated member 220.
  • the contact portion 290 corresponds to the first engagement instrument 210 side of the head 280 and is configured to be able to come into contact with a plurality of staples discharged from the discharge portion 240.
  • the staple ejected from the ejection part 240 contacts the abutting part 290 and deforms to join the first and second parts to be joined.
  • the shaft 310 is configured to be able to be inserted through a hole 30 that may be formed approximately at the center of the medical member 100, which will be described later.
  • the shaft 310 is configured to be engageable with the shaft of the positioning section 230 of the first engagement instrument 210.
  • the shaft 310 is provided with a space for accommodating the shaft of the positioning part 230 of the first engagement device 210.
  • the shaft 310 is configured to fit with the shaft of the positioning section 230, thereby allowing the first engagement instrument 210 and the second engagement instrument 270 to be aligned.
  • the medical member 100 is disposed between living organs to be anastomoses, is configured flat, and has a plurality of through holes 11 formed therein.
  • the medical member 100 includes a main body part 10, a fixing part 20, a hole part 30, and a buffer part 40, as shown in FIG. 1 and the like.
  • the main body portion 10 is disposed between living organs to be anastomosed, and has a sheet-like configuration that can follow the movement of the living organs to be anastomosed.
  • the main body part 10 is formed into a circular shape, for example, and as shown in FIG. 4, a through hole 11 is formed to be inserted in the thickness direction (axial direction X) of the circular shape. Equipped with multiple.
  • the size of the through hole 11 of the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, and still more preferably 0.6 to 1.5 mm.
  • the main body portion 10 can be configured such that the ratio between the dimension D of the through hole 11 and the pitch P is 0.25 or more and less than 40.
  • the (true) circle described as the shape of the main body portion 10 is an example, and the shape may include polygons such as an ellipse, a quadrilateral, a star shape, etc. in addition to the above.
  • the thickness of the main body portion 10 is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.
  • the main body portion 10 can be made of a biodegradable material (bioabsorbable material). There are no particular limitations on the material of the main body 10, and examples thereof include biodegradable resin.
  • (1) selected from the group consisting of aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose.
  • Polymer (2) Examples include copolymers composed of one or more monomers constituting the above (1).
  • the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose. It is preferable that 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 is included.
  • the method for manufacturing the main body portion 10 is not particularly limited, but includes, for example, a method in which fibers made of the above-mentioned biodegradable resin are manufactured and a mesh-shaped sheet is manufactured using the fibers.
  • Methods for producing fibers made of biodegradable resin are not particularly limited, and include, for example, electrospinning (electrospinning, electrostatic spinning), melt blowing, and the like.
  • the main body part 10 may select and use only one type of the above-mentioned methods, or may select two or more types and combine them as appropriate.
  • the biodegradable sheet according to the present invention can be produced by spinning fibers made of the above-mentioned biodegradable resin according to a conventional method and knitting the obtained fibers into a mesh shape.
  • the main body part 10 induces a biological reaction by the constituent material such as biodegradable resin that constitutes the main body part 10. Through this action, the main body 10 induces the expression of biological components such as fibrin.
  • the biocomponents thus induced can penetrate through the through holes 11 of the main body 10 and accumulate, thereby promoting healing. Therefore, by arranging the main body portion 10 of the medical member 100 between the biological organs to be joined, fusion is promoted by the above-described mechanism.
  • the fixing part 20 is provided with a medical device to prevent the medical member 100 from slipping or falling off when the medical member 100 is placed between a first joint site and a second joint site using the medical instrument 200. It is provided to fix the member 100 to the shaft 310 of the second engagement device 270.
  • the fixing portion 20 is formed along the inner peripheral edge of the hollow circular shape of the main body portion 10 .
  • the fixing part 20 is configured so that the through hole 11 is not provided in the main body part 10.
  • the fixing part 20 is made of bioabsorbable thermoplastic resin such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid/glycolic acid copolymer), PDS (polydioxanone), and PCL (polycaprolactone). It is preferable that the material is made of a flexible material.
  • the fixing part 20 may include a material that is not bioabsorbable. Further, the fixing part 20 may be made of a metal material other than the above. The material of the fixing part 20 may or may not have elasticity.
  • the fixing part 20 may be provided inside the main body part 10 over the entire circumference, or may be provided partially within the entire circumference. Further, although the fixing part 20 is configured to be coaxial with the inner edge, the center position may be shifted from the main body part 10 as long as it does not enter the fusion region.
  • the inner diameter of the fixing part 20 is approximately the same as or slightly larger than the outer diameter of the shaft 310 of the second engagement instrument 270 of the medical member 100.
  • the main body part 10 has a hole 30 formed in a substantially central part spaced apart from the outer peripheral edge of the main body part 10 in the radial direction r when viewed in plan from the axial direction X by the fixing part 20 .
  • the hole 30 is configured so that the shaft 310 of the medical instrument 200 can be inserted therethrough.
  • the hole 30 has a substantially circular shape when viewed from the axial direction X.
  • the specific shape of the hole is not limited to a circular shape, as long as the main body 10 can promote healing of living tissue.
  • the cross section of the hole 30 is preferably a perfect circle, but it may also have a linear, elliptical, triangular, square, concave, convex, or cross-shaped cut.
  • the buffer section 40 is configured to prevent or suppress twisting of the main body section 10 by buffering external forces that may act on the main body section 10 .
  • the buffer portion 40 is provided at the outer peripheral portion (outer edge portion) of the main body portion 10 in the radial direction r, as shown in FIG.
  • the buffer section 40 is configured to include a space section 41 that can be filled with a fluid such as gas, as shown in FIG.
  • the space portion 41 is configured to be surrounded by the buffer members 42 forming the buffer portion 40 in all directions in a cross section intersecting the circumferential direction ⁇ of the main body portion 10 .
  • one space part 41 is continuously provided in the circumferential direction ⁇ so as to surround the main body part 10, as shown in FIG.
  • the buffer section 40 can be easily molded.
  • the buffer section 40 including the space section 41 has more cushioning properties than the main body section 10 and is configured to be easily restored.
  • cushioning property means the property of absorbing a load that may act on the medical member 100
  • restoring property means that even if an external force is applied to the buffer part 40, if the external force is removed, the buffer part 40 will be able to absorb the external force. It means the property of returning or attempting to return to the shape before it was applied.
  • the thick portion of the buffer member 42 in the buffer section 40 that separates the space 41 from the outside is configured to be thicker than the thickness of the main body section 10. This makes it possible to improve the buffering function of the buffer section 40, making it difficult for the main body section 10 to deform when an external force is applied to the medical member 100, and preventing or suppressing the main body section 10 from twisting.
  • the buffer member 40 fills the space 41 with gas or the like in a sealed manner, and in this embodiment, the thick portion of the buffer member 42 that isolates the space 41 from the outside is uniform regardless of the location.
  • the cross-sectional shape of the outer wall surface and the inner wall surface along the axial direction X of the buffer member 42 that constitutes the buffer section 40 and forms the space section 41 is approximately a perfect circle, as shown in FIG. .
  • the space part 41 is configured to have more cushioning properties than the main body part 10 and be relatively harder, it will not only be less likely to deform due to external force, but also have relatively high restorability. On the other hand, if the space part 41 is configured to have more cushioning properties than the main body part 10 and to be relatively softer, it can absorb external force and easily reduce the external force applied to the main body part 10.
  • the buffer member 42 constituting the buffer part 40 is formed in an annular shape so as to be oriented around the main body part 10 at any position in the radial direction r, and in this embodiment, it is arranged on the outer peripheral part of the main body part 10. ing.
  • the buffer member 42 is configured to include an elastically deformable member, and thereby has a higher restoring force than the main body portion 10.
  • the buffer member 42 is made of bioabsorbable thermoplastic resin such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid/glycolic acid copolymer), PDS (polydioxanone), and PCL (polycaprolactone). It is preferable that the material contains a magnetic material.
  • the buffer member 42 preferably contains PLGA or PCL, especially from the viewpoint of developing restoring force. Further, in order to seal the gas filled in the space 41 by the buffer member 42, it is preferable that the buffer member 42 uses a material having lower gas permeability than the main body portion 10.
  • the buffer member 42 is configured as a separate member from the main body portion 10.
  • the buffer part may be made of the same material as the main body part 10 by rounding the outer periphery of the main body part or the like.
  • the method of joining the main body 10 and the buffer member 42 is not particularly limited, and adhesives, heat fusion, sewing with thread or the like, needle punching, etc. may be used. I can do it.
  • the method of forming the buffer section 40 is not particularly limited, but for example, several sheets may be joined together by needle punching, heat fusion, etc. to increase the thickness, and then cut into a desired shape. Then, wrap a sheet around the core metal, cover it with a shrink tube, and apply heat. Then, a method such as melting a polymer and placing it in a mold to form the buffer section 40 having the space section 41 can be adopted.
  • FIG. 7 is a flowchart showing each procedure of a treatment method using the medical member 100.
  • the treatment method involves inserting a sheet-shaped main body 10 between a first joint site and a second joint site, to which biological organs are to be joined, to promote the fusion of living tissues.
  • the method includes arranging the medical member 100 (S11).
  • the treatment method includes disposing at least a portion of the main body 10 of the medical member 100 between one first welding site and the other second welding site. This includes joining the second part to be joined (S12).
  • the living organ to be joined by the treatment method and the part to be joined in the living organ are not particularly limited and can be arbitrarily selected.
  • a colon anastomosis will be used as an example.
  • detailed explanations of known procedure procedures and known bonding devices will be omitted as appropriate.
  • placing a medical member between living organs refers to a state in which a medical member is in direct or indirect contact with a living organ. It can mean to be placed.
  • the above description may mean that the medical member is placed with a spatial gap formed between it and the living organ.
  • the above description refers to the fact that the medical component is placed in both states (for example, the medical component is placed in contact with one biological organ and not in contact with the other biological organ). (to be done).
  • peripheral does not define a strict range (area), but a predetermined range (area) as long as the purpose of treatment (connection of biological organs) can be achieved. means.
  • FIG. 8 is a flowchart showing the procedure of an embodiment of the treatment method (colon anastomosis).
  • FIGS. 9 to 11 are diagrams for explaining colorectal anastomosis.
  • the biological organ to be joined is a large intestine that has been cut during resection of a cancerous tumor.
  • the biological organs to be joined are the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine.
  • a part of the intestinal wall on the proximal side A1 of the cut large intestine (one joined part) and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other joined part) are joined.
  • the steps are described in the steps.
  • the treatment method according to the present embodiment includes arranging the medical member 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S101); This includes bringing the anal side A2 relatively closer together (S102).
  • the treatment method includes sandwiching the main body 10 of the medical member 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S103), and inserting the medical device between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S103). This includes joining the main body part 10 of the member 100 in a sandwiched state (S104). The details will be explained below.
  • the surgeon prepares the medical instrument 200, forms a hole-like region called a port around the navel, and inflates the patient's abdomen.
  • the surgeon makes an incision (not shown) around the navel, and uses a medical device called a linear stapler to remove the affected part of the colon, such as cancer. is sutured to.
  • the large intestine is separated into an oral side A1 and an anal side A2.
  • the operator takes out the proximal side A1 of the large intestine from the body through the incision, and inserts the second engagement instrument 270 of the medical instrument 200 into the proximal side A1 of the large intestine.
  • the operator inserts the second engaging instrument 270 into the proximal side A1 of the large intestine, and performs purse string suturing with the shaft 310 protruding, thereby forming a sutured portion A11.
  • the outer surface of the sutured portion A11 has a shape that partially protrudes toward the convex side due to suturing (see FIG. 9).
  • the operator inserts the shaft 310 of the second engagement instrument 270 into the hole 30 that is approximately in the center of the main body 10.
  • the operator accommodates the living tissue on the proximal side A1 of the large intestine, on which the medical member 100 is placed, into the abdominal cavity through the incision.
  • the operator uses forceps or the like to bring the tip of the second engagement instrument 270 close to the anal side A2 of the large intestine.
  • the operator places the first engaging instrument 210 of the medical instrument 200 on the anal side A2 of the large intestine by inserting the first engaging instrument 210 from the anus.
  • the positioning portion 230 (shaft) of the first engagement device 210 penetrates the sutured portion A11 near the anal side A2 of the large intestine.
  • a through hole A21 is formed on the anal side A2 of the large intestine. Note that the timing of forming the through hole A21 is not particularly limited as long as it is before the first engagement instrument 210 is placed.
  • the operator engages the positioning part 230 and the shaft 310 of the second engagement instrument 270 at a separated position while maintaining the state in which the main body part 10 is held against the oral side A1 of the large intestine ( S101). Then, the rotating part 261 is rotated to bring the first engagement instrument 210 and the second engagement instrument 270 relatively closer to each other as shown in FIG. 12 (S102). As a result, the vicinity of the mouth of the large intestine and the intestinal wall of the large intestine become relatively close to each other.
  • the operator moves between the first engagement instrument 210 and the second engagement instrument 270 the intestinal wall on the proximal side A1 of the large intestine, the main body 10 of the medical member 100, and the intestine on the anal side A2 of the large intestine.
  • the area around the through hole A21 formed in the wall is sandwiched (S103).
  • the operator rotates the handle 262 of the operating section 260 of the medical instrument 200 around the rotation axis 263 to cause the annular blade of the punching section 250 to protrude. Then, a part of the oral side A1 of the large intestine sandwiched between the first engaging instrument 210 and the second engaging instrument 270, the radially inner side of the main body 10, and a part of the anal side A2 of the large intestine are removed. Then, the circumference of the excised region is joined in a substantially annular shape using staples (not shown) (S104).
  • the operator takes the medical instrument 200 out of the living body, for example, from the anal side A2 of the large intestine through the anus.
  • a region configured inward of the outer diameter d of the punched portion 250 of the first engagement instrument 210 is taken out of the living body together with the medical instrument 200.
  • the portion of the medical member 100 located inward in the radial direction r from the punched portion 250 is removed without remaining inside the body. Note that when the main body part 10 and the fixing part 20 are not made of bioabsorbable material, the main body part 10 and the fixing part 20 are removed from the above-mentioned port.
  • the through-hole 11 is formed in a portion located outward in the radial direction r from the punched portion 250 of the main body 10.
  • the fusion of biological organs to be joined can be promoted through the main body portion 10.
  • a joining procedure for example, gastrointestinal anastomosis
  • a simple method of sandwiching the sheet-like main body 10 between the first joining site and the second joining site It is possible to reduce the risk of subsequent suturing failure, etc.
  • the medical member 100 includes the main body portion 10 and the buffer portion 40.
  • the main body part 10 can be placed at an anastomotic part of a living organ, at least a part of which contains a bioabsorbable material, and is formed into a sheet shape.
  • the buffer section 40 is configured to have a space section 41 therein.
  • the main body part 10 is relatively thin and includes a soft material, there is a risk that the main body part 10 may twist when inserted into the above-mentioned incision or when the main body part 10 is pulled. In that case, there is a possibility that the effect of fusion by the main body part during anastomosis of biological organs may be affected.
  • the medical member 100 according to the present embodiment is provided with the buffer portion 40 as described above, it is possible to prevent or suppress external force from acting on the main body 10 and prevent the main body 10 from twisting. can be prevented or suppressed from occurring.
  • the space 41 of the buffer section 40 is configured to be surrounded by the buffer members 42 forming the buffer section 40 in all directions in a cross section intersecting the circumferential direction ⁇ of the main body section 10.
  • the buffer section 40 is configured to seal the space 41 with gas. With this configuration, even if an external force acts on the main body 10 and causes the main body 10 to deform, the main body 10 can more easily be restored to its original shape due to the restoring force of the buffer section 40. The occurrence of twisting can be further prevented or suppressed.
  • the buffer section 40 has a higher restoring force than the main body section 10.
  • the main body part 10 is provided with a plurality of through holes 11, and when applied to an anastomotic part of a living organ, biological components of the living organ pass through the through holes 11 of the main part 10 and accumulate. Promote healing. With this configuration, joining of the anastomosis can be promoted.
  • the buffer section 40 is configured to be arranged on the outer periphery of the main body section 10. With this configuration, it is possible to buffer the external force that may act on the main body part 10 from approximately the outside to the inside in the radial direction r, and prevent or suppress the occurrence of twisting that may occur in the main body part 10.
  • the main body 10 is configured to include a hole 30 through which the shaft 310 of the second engagement instrument 270 of the medical device 200 can be inserted in the axial direction X of the main body 10.
  • the medical member 100 including the main body portion 10 can be quickly inserted into the shaft 310 of the second engagement instrument 270 to perform an anastomosis operation of living organs.
  • Modifications 1 to 4 of the first embodiment 12 to 15 are cross-sectional views along the axial direction X of medical members 100a, 100b, 100c, and 100d according to Modifications 1 to 4 of the first embodiment.
  • the buffer member 42 constituting the buffer section 40 of the medical member 100 has a perfect circular cross-sectional shape.
  • the specific shape of the buffer section 40 is not limited to a perfect circle as long as it can buffer external forces that may act on the main body section 10 from any direction.
  • the buffer member 42a of the buffer part 40a that forms the space 41a in the medical component 100a has an elliptical outer wall surface and an inner wall surface in a cross section along the axial direction X, as shown in FIG. (Modification 1).
  • the buffer member 42b of the buffer part 40b forming the space 41b in the medical component 100b has an outer wall surface and an inner wall surface in a polygonal shape such as a quadrangular or triangular shape in a cross section along the axial direction X. It may be formed so that (Modification 2). With this configuration, the main body portion 10 can be stably arranged at the joined portion, and misalignment of the main body portion 10 can be prevented or suppressed.
  • the buffer section 40c in the medical member 100c may be arranged such that two or more annular structural members are stacked and arranged in the axial direction X, like the buffer members 42c and 43c shown in FIGS. 14 and 15.
  • a buffer member 42c including a space 41c and a buffer member 43c including a space 44c, which constitute the buffer 40c, can be arranged to sandwich the main body 10, as shown in FIG.
  • two or more annular buffer members so as to overlap each other in the axial direction be able to.
  • a buffer member 42d forming a buffer portion 40d of the medical member 100d and a buffer member 43d forming a space 44d are attached to one side of the main body 10 in the axial direction X. They may be placed side by side. With this configuration, it is also possible to prevent or suppress the occurrence of twisting in the main body portion 10.
  • the cross-sectional shape of the buffer member constituting the buffer portion is not limited to those shown in FIGS. 12 to 15, etc., and may be star-shaped, uneven, etc. in addition to the above.
  • the configurations of the medical members 100a, 100b, 100c, and 100d other than the buffer portions 40a, 40b, 40c, and 40d according to Modifications 1 to 4 and how to use the medical members 100a, 100b, 100c, and 100d are as follows. This is the same as in the first embodiment. Furthermore, in the subsequent embodiments and modifications, the configuration of medical members other than the buffer portion and the method of using the medical members are basically the same as in the first embodiment. Therefore, explanations common to the first embodiment will be omitted.
  • FIG. 16 is a cross-sectional view of the medical member 100e according to the second embodiment along the axial direction X passing through the approximate center of the main body 10.
  • FIG. In the first embodiment it has been described that the thickness of the buffer portion 40 is uniform regardless of the location. However, if it is possible to buffer external forces that may act on the main body 10 from at least a specific direction, the thickness of the buffer member 42e that constitutes the buffer portion 40e of the medical component 100e will not be uniform, but will be different regardless of the location. A space portion 41e may be provided.
  • the buffer portion 40e has a substantially perfect circular cross-sectional external shape as shown in FIG.
  • the thickness of the buffer member 42e constituting the buffer portion 40e is configured to vary depending on the position in the radial direction r.
  • the buffer portion 40e can be configured such that the inner wall thickness in the radial direction r of the main body portion 10 is thicker than the outer wall thickness. With this configuration, it is also possible to prevent or suppress the occurrence of twisting of the main body portion 10.
  • the thickness of the buffer portion 40e adjacent to the main body portion 10 is configured to be relatively large, it can be expected that external forces that may act on the main body portion 10 can be further buffered.
  • Modifications 1 to 3 of the second embodiment 17 to 19 are cross-sectional views taken along the axial direction be.
  • the thickness of the buffer member 42e constituting the buffer section 40e is not uniform depending on the region, and that the external shape of the cross section of the buffer section 40e along the axial direction X is approximately a perfect circle.
  • the specific shape of the buffer portion is not limited to a perfect circle as long as it can buffer external forces that may act on the main body portion 10 from any direction.
  • the outer wall surface and inner wall surface of the buffer member 42f forming the space 41f in the buffer section 40f of the medical member 100f with uneven wall thickness may have an elliptical cross-sectional shape as shown in FIG. Good (Modification 1).
  • the cross-sectional shape of the outer wall surface and inner wall surface of the buffer member 42g forming the space 41g in the buffer section 40g of the medical member 100g with uneven wall thickness is configured to be a polygon such as a triangle as shown in FIG. (Modification 2).
  • the cross-sectional shape of the buffer portion 40h of the medical member 100h is approximately circular as shown in FIG.
  • Buffer members 43h provided in the same manner as the space portion 41h may be arranged in the axial direction X.
  • FIG. 20 is a plan view showing a medical member 100k according to the third embodiment.
  • the buffer section 40 is provided on the outer periphery of the main body section 10, and the buffer section 40 is provided with a hollow space 41 continuously in a circular shape so as to surround the outer periphery of the main body section 10.
  • the number of spaces constituting the internal space of the buffer is not limited to the case where one continuous space is provided as in the first embodiment.
  • the buffer section 40k of the medical component 100k is arranged on the outer periphery of the main body 10, and has a plurality of spaces 41k, 44k, 45k, and 46k constituting the internal space in the circumferential direction ⁇ so as to divide the outer periphery of the main body 10.
  • a buffer member 42k may be provided intermittently (see FIG. 20).
  • the buffer part 40k includes one row of buffer members 42k each having four internal spaces arranged in the radial direction r, such as space parts 41k, 44k, 45k, and 46k. As shown in 20, they are arranged symmetrically when viewed from above.
  • Modifications 1 to 3 of the third embodiment 21 to 23 are plan views showing medical members 100m, 100n, and 100p according to modifications 1 to 3 of the third embodiment.
  • the spaces 41k, 44k, 45k, and 46k are provided symmetrically as the internal spaces constituting the buffer section 40k of the medical member 100k.
  • the space portion corresponding to the internal space of the buffer portion does not need to be arranged symmetrically as long as external forces that may act on the main body portion 10 from any direction can be buffered.
  • the spaces 41m, 44m, and 45m of the buffer member 42m constituting the buffer portion 40m included in the medical member 100m may be arranged asymmetrically when viewed from above.
  • the space portions 41m, 44m, and 45m of the buffer member 42m constituting the buffer portion 40m may be arranged at equal angular intervals in the circumferential direction ⁇ (Modification 1).
  • the buffer section 40k is arranged on the outer periphery of the main body section 10.
  • the buffer member 42n that constitutes the buffer section 40n of the medical component 100n can be used inside the main body 10 as shown in FIG. It may be arranged at the periphery (approximately the center) or the like (Modification 2).
  • the buffer portion 40n may be arranged adjacent to the fixed portion 20 in the axial direction X.
  • the spaces 41n and 44n are arranged approximately symmetrically in this modification, but if the external force that can act on the main body 10 can be buffered, the specific shape of the space and the The arrangement is not limited to that shown in FIG. 22.
  • the buffer section 40k has been described as having one row (one circumference) of the buffer members 42k arranged in the radial direction r.
  • the buffer members 42p and 43p may be arranged in multiple rows (multiple circumferences) such as two rows in the radial direction r as shown in FIG. 23 (Modification 3). ).
  • the buffer portion 40p has annular buffer members 42p and 43p arranged adjacent to each other in the radial direction r.
  • the buffer member 42p has spaces 41p, 44p, 45p, and 46p arranged at equal angular intervals in the circumferential direction ⁇ .
  • the buffer member 43p has space portions 47p, 48p, 49p, and 51p arranged at equal angular intervals in the circumferential direction ⁇ .
  • the spaces 41p, 44p, 45p, and 46p and the spaces 47p, 48p, 49p, and 51p can be arranged so as to shift their positions in the circumferential direction ⁇ .
  • the strength of the buffer portion 40p can be improved and the effect of preventing the main body portion 10 from twisting can be improved.
  • FIG. 24 is a plan view showing a medical member 100r according to the fourth embodiment
  • FIG. 25 is a side view showing the medical member 100r of FIG. 24.
  • the third embodiment it has been explained that a plurality of spaces are provided in one annular external shape constituting the buffer section.
  • the external shape of the buffer portion is not limited to the above as long as it can buffer external forces that may act on the main body portion 10 from any direction.
  • the buffer section 40r of the medical member 100r includes a plurality of substantially spherical buffer members 42r having a space 41r, which are arranged in a row in the circumferential direction ⁇ and connected like beads, as shown in FIGS. 24 and 25. You may.
  • the method of connecting the buffer members 42r constituting the buffer section 40r is not particularly limited, and they may be connected using a member such as a thread or string, or may be joined using an adhesive or the like.
  • the thickness of the buffer member 42r may be configured to be uniform regardless of the location as in the first embodiment, or may be configured to vary depending on the location as in the second embodiment.
  • FIG. 26 is a cross-sectional view of the buffer section 40s of the medical member 100s according to the fifth embodiment, taken along the axial direction X through approximately the center of the main body section 10.
  • the buffer section 40 includes the space section 41 so as to buffer the external force acting on the main body section 10 .
  • the buffer part 40 does not necessarily have an internal space, and as shown in FIG. .), which is solid, has more cushioning properties than the main body part 10, and may include a buffer member 42s such as an elastic member with high resilience. With this configuration, it is also possible to prevent or suppress the occurrence of twisting in the main body portion 10.
  • the installation area with one side of the anastomosis site can be made relatively large.
  • the stability of medical components can be improved.
  • FIG. 27 is a cross-sectional view of a medical member 100t including a buffer section 40t having a space section 41t according to a modified example, taken along the axial direction X through the center of the main body section 10.
  • the embodiments have been described in which the number of spaces constituting the buffer section is relatively small, such as one to four.
  • the buffer section 40t will randomly and innumerably create micro-shaped spaces 41t that are extremely small compared to the external shape of the buffer section, as shown in FIG. It may be configured to include a provided buffer member 42t.
  • the specific number of the spaces 41t is not particularly limited as long as they are isolated from the outside, and the spaces may or may not be connected to each other internally.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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

Lors de la réalisation d'une anastomose à l'aide d'un élément médical en forme de feuille pour un site d'anastomose, l'application d'une force externe peut entraîner une déviation de l'élément médical. La présente invention empêche ou supprime une telle déviation. Un élément médical (100) comprend : une partie corps principale (10) en forme de feuille pouvant être placée au niveau d'un site d'anastomose d'un organe biologique, au moins une partie de la partie corps principale (10) comprenant un matériau bioabsorbable ; et une partie tampon (40) avec un espace (41) disposé à l'intérieur de celle-ci. L'espace (41) est entouré par un élément tampon (42) constituant la partie tampon (40) dans toutes les directions sur la section transversale croisant la partie corps principale (10) dans la direction périphérique.
PCT/JP2023/007988 2022-03-31 2023-03-03 Élément médical WO2023189202A1 (fr)

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JP2022-059101 2022-03-31
JP2022059101 2022-03-31

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006255411A (ja) * 2005-03-15 2006-09-28 Tyco Healthcare Group Lp 吻合複合材ガスケット
JP2008516669A (ja) * 2004-10-15 2008-05-22 タイコ ヘルスケア グループ エルピー 吻合のためのシール要素
WO2020067372A1 (fr) * 2018-09-27 2020-04-02 テルモ株式会社 Dispositif favorisant l'adhérence

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008516669A (ja) * 2004-10-15 2008-05-22 タイコ ヘルスケア グループ エルピー 吻合のためのシール要素
JP2006255411A (ja) * 2005-03-15 2006-09-28 Tyco Healthcare Group Lp 吻合複合材ガスケット
WO2020067372A1 (fr) * 2018-09-27 2020-04-02 テルモ株式会社 Dispositif favorisant l'adhérence

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