Medical Devices and Systems
A flat mesh member with through-holes and joints addresses the inefficiency in positioning sheet-like members during anastomosis, enhancing healing and anastomosis integrity by integrating with a stapler.
Patent Information
- Application Number
- JP2021159006
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-09-29
- Publication Date
- 2025-09-02
- Estimated Expiration
- 2041-09-29
AI Technical Summary
Existing methods for anastomosing biological organs, such as using a mechanical anastomosis device, often fail to efficiently position a sheet-like member at the cutting site to prevent tearing and promote healing.
A flat, mesh-like member with through-holes and separate first and second portions is used, joined by a joint, which is integrated with a stapler to facilitate precise placement and secure attachment at the anastomosis site.
The mesh member efficiently positions and secures at the cutting site, promoting healing by inducing biological reactions and maintaining the anastomosis integrity.
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Abstract
Description
[Technical Field]
[0001] The present invention relates to medical devices and systems. [Background technology]
[0002] In the medical field, surgical anastomosis of biological organs (e.g., anastomosis of the digestive tract) is known. When such a procedure is performed, it is known that the absence of delayed healing at the junction where the biological organs are joined is an important factor in determining the postoperative prognosis.
[0003] Various methods and medical instruments are used in the procedure of anastomosis of biological organs, and methods have been proposed, such as a method of suturing biological organs with biodegradable sutures and a method using a mechanical anastomosis device that performs anastomosis with a stapler. In particular, when performing anastomosis using a mechanical anastomosis device, the joining strength between biological organs at the joint can be increased compared to methods using sutures, making it possible to reduce the risk of anastomosis failure.
[0004] In procedures for anastomosing biological organs, a medical device such as a linear stapler may be used to remove a portion of cancer or other cancerous tissue. A linear stapler includes a cartridge portion that houses staples, a knife portion that can move linearly inside the cartridge, and an anvil portion that is rotatable separately from the cartridge and receives the staples discharged from the cartridge (see Patent Document 1). [Prior art documents] [Patent documents]
[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2014-094286 Summary of the Invention [Problem to be solved by the invention]
[0006] In a procedure such as the above-mentioned anastomosis, a sheet-like member may be sandwiched at the anastomosis site to prevent tearing, etc., at the anastomosis site. The present inventors have been actively studying methods for placing a sheet-like member at the cutting site when cutting a biological organ with a medical device such as the linear stapler of Patent Document 1, in order to remove the above-mentioned cancerous site before anastomosis of the biological organ.
[0007] The present invention has been made to solve the above-mentioned problems, and aims to efficiently position a flat sheet-like member at the cutting site when cutting the biological organ to be anastomosed before anastomosis. [Means for solving the problem]
[0008] One aspect of the present invention comprises a mesh member and a joint. The mesh member is placed between biological organs to be anastomosed, is flat, has a plurality of through-holes formed therein, and comprises a first portion and a second portion. The joint portion joins the biological organ and the mesh member with a joint member. The mesh member has a substantially arc-shaped portion corresponding to the anastomosis portion of the biological organ.
[0009] One aspect of the present invention is The anastomosis device comprises a mesh-like member that is placed between biological organs to be anastomosed, is flat, has a plurality of through holes formed therein, and has a first part and a second part that are constructed separately, and a joint joined to the mesh-like member, wherein the joint is configured to connect the first part and the second part in a separated state by being formed in a strip shape, and the mesh-like member has an approximately arc-shaped part that corresponds to the anastomosis part of the biological organs. [Effects of the Invention]
[0010] According to one aspect of the medical device and medical system of the present invention, when cutting a biological organ to be anastomosed before anastomosis, a flat sheet-like member can be efficiently placed at the cutting site. [Brief explanation of the drawings]
[0011] [Figure 1] 1 is a schematic view showing a stapler (medical device, linear stapler) used in a procedure using a medical instrument according to a first embodiment of the present invention. [Figure 2] 2 is a perspective view showing a first clamping section and a second clamping section of the stapler shown in FIG. 1. FIG. [Figure 3]2 is a side view showing a first clamping section and a second clamping section of the stapler shown in FIG. 1. FIG. [Figure 4] FIG. 2 is a perspective view showing a stapler (circular stapler) different from that shown in FIG. 1, which is used for anastomosis of a medical instrument. [Figure 5] 5 is a perspective view showing the tip of a first engaging device and a second engaging device of the stapler shown in FIG. 4. FIG. [Figure 6] FIG. 2 is a view showing a mesh member of the medical device according to the first embodiment. [Figure 7] 7 is a diagram showing a state in which linear members for fixing parts are arranged on a mesh member for the medical device of FIG. 6. FIG. [Figure 8] 7 is a diagram showing a state in which the dimensions of the mesh member in FIG. 6 in the planar direction are reduced. [Figure 9] FIG. 4 is an enlarged view showing through holes in the mesh member. [Figure 10] 1 is a flowchart showing an example of use (treatment method) of the medical device. [Figure 11] 1. FIG. 4 is a diagram showing how the dimensions of the medical instrument in the planar direction are reduced and the medical instrument is integrated into the stapler of FIG. [Figure 12] 2 is a diagram showing how a biological organ such as an intestinal tract is clamped by the stapler of FIG. 1 integrated with a medical instrument. FIG. [Figure 13] 1. FIG. 4 is a diagram showing a state where a living organ such as an intestinal tract is cut by the stapler of FIG. 1 and a medical instrument is placed at the cut site. [Figure 14] 1. FIG. 4 is a diagram showing a medical instrument being placed at the site cut by the stapler of FIG. 1, and one of the cut sites being excised. [Figure 15] 5 is a diagram showing how the intestinal tracts cut by the stapler in FIG. 4 are brought closer together. FIG. [Figure 16] 5 is a view showing a state in which a living organ cut by a first engaging instrument and a second engaging instrument of the stapler of FIG. 4 is brought into contact with each other via a medical instrument. FIG. [Figure 17] FIG. 5 is a diagram showing how anastomosis and punching are performed on a partially resected living organ by the stapler of FIG. 4. [Figure 18] FIG. 10 is a diagram showing a mesh member of a medical device according to a first modification of the first embodiment. [Figure 19] 19 is a diagram showing a medical device in which linear members for fixing parts are arranged on the mesh member of FIG. 18. FIG. [Figure 20] FIG. 10 is a view showing a mesh member of a medical device according to a second modification of the first embodiment. [Figure 21] 21 is a diagram showing a medical device in which a linear member of a fixing part is disposed on the mesh member of FIG. 20. FIG. [Figure 22] 21 is a diagram showing the mesh member of FIG. 20 in a state where it is spread out on a stapler. FIG. [Figure 23] FIG. 10 is a diagram showing a mesh member of a medical device according to a third modification of the first embodiment. [Figure 24] FIG. 24 is a diagram showing a medical device in which a linear member for a fixing portion is disposed on the mesh member of FIG. 23. [Figure 25] FIG. 24 is a diagram showing the mesh member of FIG. 23 in a state where it is spread out on a stapler. [Figure 26] FIG. 10 is a view showing a reinforcing portion of a mesh member of a medical device according to a fourth modification of the first embodiment. [Figure 27] FIG. 11 is a view showing a reinforcing portion of a mesh member of a medical device according to a fifth modification of the first embodiment. [Figure 28] FIG. 13 is a view showing a reinforcing portion of a mesh member of a medical device according to a sixth modification of the first embodiment. [Figure 29] FIG. 13 is a diagram showing an aspect in which the dimension in the planar direction of a mesh member according to Modification 7 of the first embodiment is reduced. [Figure 30] FIG. 13 is a diagram showing an aspect in which the dimension in the planar direction of a mesh member according to Modification 8 of the first embodiment is reduced. [Figure 31] FIG. 13 is a diagram showing an aspect in which the dimension in the planar direction of a mesh member according to a ninth modification of the first embodiment is reduced. [Figure 32] FIG. 10 is a diagram showing a connection between a mesh member of a medical instrument and the stapler of FIG. 1, as a tenth modification of the first embodiment. [Figure 33] 33 is a schematic view showing the connection between the mesh member of FIG. 32 and the stapler of FIG. 1. FIG. [Figure 34] 33 is a partially enlarged view showing the connection between the mesh member shown in FIG. 32 and the stapler shown in FIG. 1. FIG. [Figure 35] 13A to 13C are diagrams illustrating a method for expanding a mesh member according to an eleventh modification of the first embodiment from a reduced size state into a flattened shape. [Figure 36] FIG. 36 is a diagram showing a state before the mesh is deployed, in which a hollow member different from that in FIG. 35 is placed in a mesh-like member, as an eleventh modification of the first embodiment. [Figure 37] FIG. 37 is a diagram showing the mesh member shown in FIG. 36 in an expanded state. [Figure 38] 13 is a diagram showing a state in which a mesh member is integrated into the stapler of FIG. 1 by a fixing portion according to a twelfth modification of the first embodiment. FIG. [Figure 39] 39 is a diagram showing how the linear member inserted into the stapler is pushed out by moving the cutting portion of the stapler from the state shown in FIG. 38, thereby releasing the integration of the mesh member and the stapler. [Figure 40] 39 is a diagram showing how the mesh member in FIG. 38 is wound around a stapler. FIG. [Figure 41] 10A and 10B are diagrams showing how the mesh member according to the second embodiment is integrated into a stapler. [Figure 42] FIG. 10 is a diagram showing a manner in which a mesh member according to Modification 1 of the second embodiment is integrated with a stapler. [Figure 43] FIG. 10 is a diagram showing a mode in which a mesh member according to Modification 2 of the second embodiment is integrated with a stapler. [Figure 44] FIG. 10 is a diagram showing a manner in which a mesh member according to Modification 3 of the second embodiment is integrated with a stapler. [Figure 45] 45 is a diagram showing a state in which the fixing part has been removed from the mesh member from the state shown in FIG. 44. FIG. [Figure 46]FIG. 10 is a view showing a state in which the dimension of the mesh member in the planar direction is reduced by a fixing portion of a medical device according to a third embodiment. [Figure 47] 47 is a view showing a state in which the mesh member is released from the state shown in FIG. 46 by sliding the fixing part of the medical device. FIG. [Figure 48] FIG. 10 is a view showing a fixing part of a medical device according to a third embodiment. [Figure 49] 1. FIG. 10 is a diagram showing a state in which a mesh member is integrated with the stapler of FIG. 1 by a fixing portion according to a fourth embodiment. DETAILED DESCRIPTION OF THE INVENTION
[0012] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the claims and their equivalents.
[0013] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.
[0014] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not stipulate any particular order.
[0015] In the following, a coordinate system is shown in the drawings including the stapler 200. X in the Cartesian coordinate system is along the longitudinal direction of the first clamping unit 210 and the second clamping unit 220 constituting the stapler 200, and is referred to as the longitudinal direction X. Y is along the width direction of the first clamping unit 210, etc., which intersects with the longitudinal direction X, and is referred to as the width direction Y. Z is along the height direction of the second clamping unit 220, etc., and is referred to as the height direction Z.
[0016] First Embodiment Figures 1 to 3 are views showing a stapler 200 constituting a medical system 1 according to the first embodiment. Figures 4 and 5 are views explaining a stapler 300 used in a procedure using a medical instrument 100. Figures 6 and 7 are views showing the medical instrument 100, Figure 8 is a view showing the medical instrument 100 in a reduced size, and Figure 9 is an enlarged view showing a through-hole 11 of the medical instrument 100.
[0017] FIG. 10 shows a flowchart of a treatment method using the medical device 100, and FIGS. 11 to 17 are diagrams illustrating anastomosis of the digestive tract, taking the large intestine as an example, using the medical device 100 that constitutes the medical system 1.
[0018] The medical system 1, which will be generally described with reference to FIG. 11, includes a medical instrument 100 and a stapler 200 that is used together with the medical instrument 100 during anastomosis.
[0019] 11 to 17, the medical device 100 can be applied to a procedure for joining predetermined biological organs together (for example, anastomosis of the digestive tract). As will be described later, in this specification, colon anastomosis will be described as an example of a procedure using the medical device 100, but the site where the healing promoting device according to the present invention can be used is not limited to the large intestine.
[0020] The medical system 1 is used to separate the large intestine or the like and join a first portion to be joined and a second portion to be joined of the large intestine or the like using staplers 200 and 300 shown in Figures 1, 4, etc. In explaining the medical system 1, the staplers 200 and 300 will be explained.
[0021] <Stapler 200> Stapler 200 is used to cut a portion of a living organ such as the large intestine to remove a cancer or other lesion, and then automatically suture the cut surface. As shown in FIGS. 1 to 3, stapler 200 includes first clamping unit 210, second clamping unit 220, and operating unit 230. Stapler 200 may also be called a linear stapler. The configuration of each unit will be described below.
[0022] First clamping unit 210 and second clamping unit 220 each include a linear member and are configured to be rotatable around one end or the vicinity of the end of the linear member as a rotation axis Pa (see FIG. 3). This allows the biological organ to be clamped by first clamping unit 210 and second clamping unit 220.
[0023] The first clamping unit 210 is configured to include a cartridge that discharges staples (corresponding to joining members). A plurality of staple discharge holes 211 are provided on the side of the first clamping unit 210 that clamps the living organ, facing the second clamping unit 220 (see FIG. 2).
[0024] As shown in Fig. 2, a cutting unit 212 for cutting a biological organ is provided near the approximate center of the first clamping unit 210 in the width direction Y. The cutting unit 212 includes a sharp knife or cutter that is movable in the longitudinal direction X. For convenience, Fig. 2 shows a groove through which the cutter or the like can travel.
[0025] The second clamping unit 220 includes an anvil or the like that receives the staples discharged from the first clamping unit 210. This allows the staples discharged from the first clamping unit 210 to be folded back, and the periphery of the cut site of the living organ to be sutured so that one side of the cut site and the other side are held together without separation.
[0026] The operating unit 230 is configured to be grippable by the user's fingers, etc. The operating unit 230 includes a main body that comes into contact with the user's palm, etc., and a trigger that comes into contact with the fingers and is rotatably fixed to the main body, etc. When the user grips the operating unit 230 and operates the trigger, etc., the first clamping unit 210 and the second clamping unit 220 can clamp the biological organ, the cutting unit 212 provided in the first clamping unit 210 can cut the biological organ, and the staples can be released from the release holes 211 in the first clamping unit 210. The released staples automatically join the biological organ.
[0027] <Stapler 300> The stapler 300 automatically joins one portion to be joined (first portion to be joined), which is a biological organ in biological tissue, to another portion to be joined (second portion to be joined) facing the first portion to be joined. As shown in FIG. 4 and other figures, the stapler 300 includes a first engaging instrument 310 and a second engaging instrument 370 that can clamp the medical instrument 100 via the first portion to be joined and the second portion to be joined. The stapler 300 may be called a circular stapler. The configuration of each part will be described below.
[0028] As shown in Figures 4, 5, etc., the first engagement device 310 is placed on one side of the medical device 100 when anastomosing the medical device 100 to biological tissue.
[0029] The second engaging instrument 370 is placed on the opposite side of the medical instrument 100 from the first engaging instrument 310 during anastomosis. The first engaging instrument 310 may be called a trocar, and the second engaging instrument 370 may be called an anvil. These will be described in detail below.
[0030] <First engagement device> As shown in FIGS. 4 and 5, the first engagement device 310 includes an elongated member 320, a positioning portion 330, a release portion 340, a punching portion 350, and an operating portion 360.
[0031] The elongated member 320 corresponds to the main body of the first engaging device 310. As shown in Fig. 5, the elongated member 320 has a space S at its longitudinal tip that allows the shaft of the positioning unit 330 to move back and forth relatively. In this specification, the direction that extends linearly at the tip of the elongated member 320 is defined as the longitudinal direction. The cross section of the elongated member 320 that intersects with the longitudinal direction of the stapler 300 is configured to be hollow and circular.
[0032] In this embodiment, the elongated member 320 extends linearly in the longitudinal direction and has bent portions, but the elongated member does not need to have bent portions as long as it can achieve the anastomosis function and punching function described below.
[0033] The positioning part 330 includes a long shaft. As shown in Fig. 5, the shaft of the positioning part 330 is configured to be movable relatively forward and backward from the space S at the tip in the longitudinal direction of the elongated member 320. The positioning part 330 is configured to be insertable into a hole (see hatching in Fig. 26) that may be formed in the approximate center of the medical device 100 and into the inner cavity of a shaft 410 of a second engaging device 370, which will be described later.
[0034] The release portion 340 is configured to be able to release, in a substantially annular shape, a plurality of staples that anastomose the first and second joint portions. The release portion 340 is formed in a substantially disk shape on the distal end side in the longitudinal direction of the elongated member 320. The release portion 340 is configured by providing a plurality of staple release points along the circumferential direction at the distal end of the elongated member 320.
[0035] Punching portion 350 is disposed radially inward of release portion 340 at the tip of elongated member 320, and is configured to punch radially inward of the biological organ to be anastomosed. As shown in Fig. 5, punching portion 350 is configured to have an annular blade that punches the biological organ radially inward of release portion 340. The shape of punching portion 350 can be configured to be a perfect circle when viewed in a plan view from the longitudinal direction, but the shape of punching portion 350 may be other than a perfect circle, such as an ellipse, as long as it can punch out portions unnecessary for promoting healing.
[0036] The operating unit 360 is configured to be able to operate the positioning unit 330, the discharging unit 340, and the punching unit 350. The operating unit 360 includes a rotating unit 361 and a handle 362, as shown in FIG.
[0037] The rotating part 361 is provided at the base end (base end side) in the longitudinal direction of the elongated member 320. The rotating part 361 is configured to be rotatable relative to the elongated member 320, with the longitudinal direction at the base end side of the elongated member 320 serving as a rotation axis. The rotating part 361 is configured to be able to move the first engaging device 310 and the second engaging device 370 relatively closer to or farther away from each other by rotating relative to the elongated member 320 when the second engaging device 370 is engaged with the first engaging device 310.
[0038] The handle 362 is configured to be grippable by the user together with the base end (base end side) of the elongated member 320. The handle 362 is rotatably connected to the elongated member 320 by a rotation shaft 363. When gripped by the user, the handle 362 rotates around the rotation shaft 363 and moves relatively close to the elongated member 320. This allows staples to be released from the release portion 340 and the annular blade of the punching portion 350 to protrude from the tip of the elongated member 320.
[0039] <Second engagement device> The second engaging instrument 370 is configured to be able to clamp the medical instrument 100 together with the first engaging instrument 310 via the biological organ to be anastomosed. The second engaging instrument 370 includes a head, an abutting portion 380, and a shaft 410, as shown in FIG.
[0040] The head is disposed adjacent to the elongated member 320 of the first engaging device 310, particularly the distal end side thereof, when the first engaging device 310 and the second engaging device 370 are engaged with each other. In this embodiment, the head is configured in a substantially circular plate shape as shown in Figures 4 and 5, and its cross-sectional shape is configured to be the same as or similar to the circular shape of the elongated member 320.
[0041] The abutting portion 380 is provided on the opposite side of the head and is configured to be able to abut against the plurality of staples discharged from the discharge portion 340. The abutting portion 380 is provided on the side of the first engaging device 310 in the longitudinal direction (plate thickness direction) of the head. The abutting portion 380 is configured to be able to abut against the plurality of staples discharged from the discharge portion 340. The staples discharged from the discharge portion 340 abut against the abutting portion 380 and are deformed to anastomose one biological organ and the other biological organ.
[0042] The shaft 410 is configured so as to be able to be inserted through approximately the center of the medical device 100 (see hatching in FIG. 26). The cross section of the shaft 410 intersecting the longitudinal direction is configured to be hollow and circular.
[0043] The shaft 410 has a space for accommodating the shaft of the positioning portion 330 of the first engagement device 310. The shaft 410 is configured to fit with the shaft of the positioning portion 330, which allows the first engagement device 310 and the second engagement device 370 to be aligned.
[0044] <Medical Devices 100> The medical device 100 is placed between biological organs to be anastomosed, and is flat with a plurality of through-holes 11. The medical device 100 includes a mesh member 10, a joint portion 20, and a fixing portion 30, as shown in Figures 6, 7, 9, etc.
[0045] <Mesh-like material> The mesh member 10 is placed between biological organs to be anastomosed, and is applied to the anastomotic site of the biological organs to promote healing of the biological tissues. The mesh member 10 is configured in the shape of a flat sheet, as shown in Fig. 6 etc.
[0046] As shown in Fig. 6, the mesh member 10 has first portions 12, 13 and second portions 14, 15. The first portions 12, 13 and the second portions 14, 15 will be described later. The mesh member 10 has a plurality of through holes 11 formed so as to penetrate in the thickness direction, as shown in Fig. 9. The size of the through holes 11 in the mesh member 10 is, for example, preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, and even more preferably 0.6 to 1.5 mm. The mesh member 10 can be configured so that the ratio of the dimension D of the through holes 11 to the pitch P is 0.25 or more and less than 40.
[0047] The thickness of the mesh member 10 (dimension T shown in FIG. 9) is not particularly limited, but is preferably 0.05 to 0.3 mm, and more preferably 0.1 to 0.2 mm.
[0048] The mesh member 10 can be made of a biodegradable material. There are no particular limitations on the material that can be used to make the mesh member 10, and examples of the material include biodegradable resins.
[0049] Specifically, examples include (1) polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of one or more monomers constituting the above (1).
[0050] That is, it is preferable that the biodegradable sheet contains at least one biodegradable resin selected from the group consisting of polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose, as well as copolymers composed of one or more monomers that constitute the above polymers.
[0051] As shown in FIG. 6, the mesh member 10 includes first portions 12 and 13 and second portions 14 and 15.
[0052] In this embodiment, the first portions 12, 13 and the second portions 14, 15 are each configured to have a substantially semicircular shape. The first portions 12, 13 and the second portions 14, 15 are configured as portions that protrude (are not clamped) from the first clamping portion 210 or the second clamping portion 220 when integrated with the stapler 200. The first portion 12 and the second portion 14 cover one cut portion of the intestinal tract, etc. (the anal side A2 in the method described below) when the living organ is cut by the stapler 200. The first portion 13 and the second portion 15 cover the other cut portion of the intestinal tract (the oral side A1) when the living organ is cut by the stapler 200.
[0053] The first portions 12, 13 and the second portions 14, 15 can be integrated with the stapler 200 until the living organ is severed. As an example, the first portions 12, 13 can be integrated with the stapler 200 on the side of the first clamping portion 210 of the stapler 200. The second portions 14, 15 can be integrated with the stapler 200 on the side of the second clamping portion 220 of the stapler 200.
[0054] The first portions 12, 13 and the second portions 14, 15 are configured to have a substantially arc-shaped portion on the outer periphery as shown in Fig. 6. This allows the substantially arc-shaped portion to be applied to the cut portion of the biological organ when the mesh member 10 having the first portions 12, 13 and the second portions 14, 15 is cut with the stapler 200.
[0055] The mesh member 10 is configured to have reinforcing portions 16, 17 in the first portions 12, 13 and the second portions 14, 15. The reinforcing portions 16, 17 reinforce the expansion of the mesh member 10 in the planar direction from a state in which the dimensions of the mesh member 10 in the planar direction are reduced.
[0056] The mesh member 10 is required to have at least a ring-shaped portion that can come into contact with the cut site of the living organ, but the provision of reinforcing portions 16 and 17 makes it easier to unfold the mesh member 10 and maintain it in a state free from twisting and overlapping. The reinforcing portions 16 and 17 will be described in detail later.
[0057] It is also preferable to provide a peripheral reinforcing portion around the periphery of the mesh member 10 to facilitate deployment of the mesh member 10 and to facilitate maintaining the deployed state. The peripheral reinforcing portion is preferably made of a bioabsorbable material such as a thermoplastic resin, such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic-glycolic acid copolymer), PDS (polydioxanone), or PCL (polycaprolactone). The peripheral reinforcing portion may or may not be provided around the entire periphery of the mesh member 10.
[0058] <Joint part> Joint portion 20 is provided on mesh member 10 and serves as a portion that joins first portion 12 and second portion 14 together by staples of stapler 200, and also joins first portion 13 and second portion 15 together. To explain the joining of first portion 12 and second portion 14, mesh member 10 is bent so that first portion 12 and second portion 14 in FIG. 6 overlap while being sandwiched between stapler 200. At this time, joint portion 20 located on the left side of first portion 12 and joint portion 20 located on the left side of second portion 14 are joined together by a joining member (staple), thereby joining first portion 12 and second portion 14 together. The same applies to first portion 13 and second portion 15. Furthermore, the joining members (staples) that penetrate the joining portions 20 of the mesh member 10 also penetrate the cut site near the anastomosis site of the biological organ, joining the area near the anastomosis site of the biological organ to the mesh member 10, thereby fixing the mesh member 10 to the cut site of the biological organ. As shown in Figure 6, the joining portions 20 are provided between the first portion 12 and the second portion 14 and between the first portion 13 and the second portion 15, and are clamped by the first clamping portion 210 and the second clamping portion 220. The joining portions 20 can be formed into a rectangle, for example, but are not limited to this, and may also be formed into a circle, a triangle, or a star shape.
[0059] The joint portion 20 joins the first portions 12, 13 and the second portions 14, 15 when staples are released and driven from a first clamping portion 210 of the stapler 200. The joint portion 20 is clamped by the stapler 200 when the medical device 100 is integrated with the stapler 200, while the first portions 12, 13 and the second portions 14, 15 are not clamped. The mesh member 10 is formed so that the orientation of the joint portion 20 after cutting the biological organ is different between the first portions 12, 13 and the second portions 14, 15.
[0060] The joints 20 can be provided at two locations in the first portions 12, 13 as intersections between a thick arc shape and a band shape, as shown in FIG. 6 , so as to contact the resection site of the biological organ. Similar to the first portions 12, 13, the joints 20 can also be provided at two locations in the second portions 14, 15 as intersections between a thick arc shape and a band shape. The joints 20 between the first portions 12, 13 can be connected, and the connecting portion between the joints 20 is referred to as a reinforcing portion 16 in this specification. In addition to the connecting portion between the joints 20 between the first portions 12, 13, a reinforcing portion can be provided at a portion radially inward from the inner side ch of the thick arc shape of the first portions 12, 13, and this portion is referred to as a reinforcing portion 17 in this specification. The reinforcing portions 16, 17 described above can also be provided in the second portions 14, 15 in a similar manner. 6, the first portions 12, 13 and the second portions 14, 15 may be connected by a joint 20. In order to enhance the reinforcing effect of the portion joined by the stapler 200, the joint 20 is preferably formed in a band shape pr outward from the arc shapes of the first portions 12, 13 and the second portions 14, 15 as a portion where the mesh member 10 exerts a healing effect, as shown in FIG. 6. The material and structure of the joint 20 may be the same as those of the mesh member 10, or the joint 20 may be made of a material and structure suitable for joining that are different from those of the mesh member 10, and the joint 20 may be a member separate from the mesh member 10.
[0061] <Fixed part> The fixing unit 30 fixes the mesh member 10 in a state in which the dimensions in the planar direction of the mesh member 10 are reduced. The mesh member 10 is inserted into the body (intraperitoneal cavity) in a state in which the dimensions are reduced by the fixing unit 30, and is configured so that it can be temporarily integrated with the stapler 200. In this embodiment, the fixing unit 30 includes a long linear member that restricts the shape of at least a part of the mesh member 10 so that the dimensions of the mesh member 10 are reduced, as shown in FIG.
[0062] In this embodiment, as shown in Figures 7 and 8, the linear member associated with the fixing unit 30 is inserted through a portion of the mesh member 10 and is arranged so as to pass around the outer periphery of the first clamping unit 210 or the second clamping unit 220 through which the cutting unit 212 passes, with the mesh member 10 folded in a zigzag pattern. By arranging the linear member associated with the fixing unit 30 in this manner, the mesh member 10 is maintained in a reduced size. The linear member associated with the fixing unit 30 is arranged in the first clamping unit 210 with the first portions 12 and 13 reduced in size, and is arranged in the second clamping unit 220 with the second portions 14 and 15 reduced in size.
[0063] The linear members of the fixing unit 30 are configured to be cuttable by the cutting unit 212 of the stapler 200. This allows the mesh member 10 of the medical device 100 to be integrated with the stapler 200 until the biological organ is cut. On the other hand, when the biological organ is cut, the linear members of the fixing unit 30 are cut by the cutting unit 212, allowing the mesh member 10 to be expanded from the state in which its dimensions have been reduced by the fixing unit 30 into a flat shape. In this specification, the term "flat shape" includes not only the case in which the mesh member 10 is transformed from its reduced dimensional state into a completely flat shape, but also the case in which the mesh member 10 is transformed from its reduced dimensional state into a shape that approaches a flat shape, although it does not completely flatten.
[0064] The linear member of the fixing part 30 is preferably a bioabsorbable thread or ribbon-like member. Since the linear member of the fixing part 30 can remain in the living body, it is more preferable that it is a thin thread. When the linear member of the fixing part 30 is retrieved with forceps or the like, the material may be a non-bioabsorbable material. It is preferable that the linear member of the fixing part 30 is provided at one or more locations for the first clamping part 210 and the second clamping part 220.
[0065] The method for producing the mesh member 10 is not particularly limited, and examples thereof include a method of producing fibers made of the above-mentioned biodegradable resin and using the fibers to produce a mesh-shaped sheet. The method for producing fibers made of a biodegradable resin is not particularly limited, and examples thereof include electrospinning (electrospinning / electrostatic spinning) and melt-blowing. The mesh member 10 may be produced by selecting only one of the above methods, or by selecting and combining two or more of them as appropriate. Further examples of the method for producing the mesh member 10 include a method for producing a biodegradable sheet according to the present invention by spinning fibers made of the above-mentioned biodegradable resin in accordance with a conventional method and knitting the obtained fibers into a mesh, a method for producing the biodegradable sheet by compressing the fibers, and a method for producing the biodegradable sheet by intertwining the fibers without weaving them.
[0066] The mesh member 10 induces a biological reaction due to the constituent materials, such as biodegradable resin, that compose the mesh member 10. Through this action, the mesh member 10 induces the expression of biological components, such as fibrin. The biological components induced in this manner can promote healing by penetrating and accumulating through the through-holes 11 of the mesh member 10. Therefore, by placing the mesh member 10 of the medical device 100 between the biological organs to be joined, healing is promoted by the above-mentioned mechanism. It is preferable that the mesh member 10 including the joint 20 has the above-mentioned healing-promoting effect.
[0067] <Treatment method> Next, a treatment method using the medical device 100 will be described.
[0068] 10, the mesh member 10 is inserted into the abdominal cavity together with the stapler 200 while its dimensions are reduced (S101). The biological organ to be anastomosed is cut, and the cut portion is sandwiched between the first portions 12, 13 and the second portions 14, 15 of the mesh member 10 and sutured (S102). The medical device 100 is placed between one of the sites to be joined and the other of the sites to be anastomosed, and the two are brought relatively close together (S103). The mesh member 10 of the medical device 100 is sandwiched between one of the sites to be joined and the other of the sites to be joined (S104). With the mesh member 10 sandwiched between the one of the sites to be joined and the other of the sites to be joined, the two are anastomosed (S105).
[0069] The biological organs to be joined and the sites of the biological organs to be joined by the above-described treatment method are not particularly limited and can be selected arbitrarily. However, the following description will be given using colorectal anastomosis as an example. Furthermore, detailed descriptions of known procedures and known joining devices for each procedure described below will be omitted as appropriate.
[0070] Hereinafter, in the description of this specification, "placing a mesh-like member between biological organs (hereinafter referred to as the above description)" may mean that the mesh-like member is placed in direct or indirect contact with the biological organs.
[0071] The above description may also mean that the mesh member is placed with a spatial gap formed between it and a biological organ, or that the mesh member is placed in both of these states (for example, the mesh member is placed in contact with one biological organ and not in contact with the other biological organ).
[0072] Furthermore, in the description of this specification, the term "periphery" does not specify a strict range (area), but rather means a predetermined range (area) as long as the purpose of the treatment (joining of biological organs) can be achieved.
[0073] Furthermore, the order of the procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. Furthermore, in the explanation of this specification, "relatively approaching" means both bringing two or more objects closer to each other and bringing only one object closer to the other.
[0074] In the treatment method according to this embodiment, the biological organ to be joined is the large intestine that has been cut following the resection of a cancer tumor. Specifically, the biological organ to be joined is the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. The following describes the procedure for joining the area around the mouth of the oral side A1 of the cut large intestine (one of the areas to be joined) and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other area to be joined).
[0075] First, the surgeon creates a hole-like area called a port around the navel and inflates the patient's abdomen.
[0076] Next, as shown in Figure 11 etc., the surgeon deforms the mesh member 10 by folding it in a zigzag pattern to reduce its size, and then performs operations such as tying it with the linear members of the fixing part 30 to integrate the mesh member 10 and the first clamping part 210 while maintaining the reduced size. The surgeon also integrates the mesh member 10 with the second clamping part 220 of the stapler 200 using the linear members of the fixing part 30. Note that the medical device 100 can be sold in a state where it is integrated with the stapler 200, in which case the above-mentioned operation by the surgeon can be omitted.
[0077] Next, the surgeon forms an incision (not shown) around the navel and inserts the stapler 200, with the first clamping portion 210 and the second clamping portion 220 closed, into the abdominal cavity (S101). By this operation, the medical instrument 100 integrated with the stapler 200 is also inserted into the abdominal cavity. Next, the surgeon opens the first clamping portion 210 and the second clamping portion 220, and clamps the intestinal tract (the portion to be cut) with the first clamping portion 210 and the second clamping portion 220. By this operation, at least a portion of the mesh member 10 is clamped by the first clamping portion 210 and the second clamping portion 220. Next, the surgeon operates the operating unit 230 to close the first clamping unit 210 and the second clamping unit 220, thereby releasing the staple from the release hole 211 toward the second clamping unit 220 and suturing the area around the intended cutting site, while moving the cutting unit 212 to cut off the target intestinal tract, etc.
[0078] The linear members of the fixing portions 30 are cut by cutting with the cutting portion 212 of the stapler 200, and the mesh member 10 is no longer integrated with the stapler 200. As a result, the mesh member 10 other than the joint portions 20 is deformed from its small size and unfolded into an arc shape. The mesh member 10 is clamped together with the intended cut portion by the stapler 200, and the first portion 12 and the second portion 14 are sutured (joined) together with the vicinity of the cut portion by discharging staples from the stapler 200, and the first portion 13 and the second portion 15 are also sutured (joined) together with the vicinity of the cut portion (S102). The joint portions 20 are clamped by the first clamping portion 210 and the second clamping portion 220, and are formed to stand up relative to the mesh member 10 other than the joint portions 20. The first portion 12 and the second portion 14 constituting the mesh member 10 are integrated together by the joint portions 20 being joined by the stapler 200, and are formed into a substantially circular shape. The same applies to the first part 13 and the second part 15. In this description, the first part 12 and the second part 14 are arranged so as to cover the incision site on the anal side A2, and the first part 13 and the second part 15 are arranged so as to cover the incision site on the oral side A1 (see FIG. 14). At this point, the surgeon removes the stapler 200, which is no longer integrated with the mesh member 10, from the body.
[0079] Next, the surgeon removes one of the cut sites where the mesh member 10 was placed. Colon anastomosis is performed when there is a site to be excised, such as a cancerous site, and in this explanation, it is assumed that a portion of the cut site pt1 on the oral side A1 is removed (see Figure 14). At this time, the first portion 13 and the second portion 15 of the mesh member 10 placed in the cut site on the oral side A1 are removed, while the first portion 12 and the second portion 14 placed in the anal side A2 are left in the living organ.
[0080] Next, the surgeon removes the affected area on the oral side A1 from the body and inserts the second engagement tool 370 of the stapler 300 into the oral side A1 of the large intestine. The surgeon inserts the head of the second engagement tool 370 into the oral side A1 of the large intestine and performs a purse-string suture with the shaft 410 protruding, forming the sutured portion A11. The outer surface of the sutured portion A11 may have a shape that partially protrudes to the convex side as a result of the suturing.
[0081] Next, the surgeon places the living tissue on the oral side A1 of the large intestine into which the second engaging tool 370 has been inserted into the body through the incision.
[0082] Next, the surgeon places the first engaging instrument 310 of the stapler 300 on the anal side A2 of the large intestine. As the first engaging instrument 310 is placed (inserted) on the anal side A2 of the large intestine, a through-hole A21 is formed on the anal side A2 of the large intestine and between the first portion 12 and the second portion 14 of the mesh member 10. The timing of forming the through-hole A21 is not particularly limited as long as it is formed after the first engaging instrument 310 is placed.
[0083] Next, while maintaining the mesh member 10 held against the mouth side A1 of the large intestine, the surgeon engages the shaft of the positioning unit 330 with the shaft 410 of the second engaging instrument 370 in a spaced-apart position. Then, the rotating unit 361 is rotated to bring the first engaging instrument 310 and the second engaging instrument 370 relatively closer to each other, as shown in Figures 15 and 16. This brings the area around the mouth of the large intestine and the wall of the large intestine relatively closer to each other (S103).
[0084] Next, the surgeon clamps the area around the mouth of the oral side A1 of the large intestine, the mesh member 10 of the medical device 100, and the area around the through-hole A21 formed in the intestinal wall on the anal side A2 of the large intestine between the first engaging device 310 and the second engaging device 370 (S104).
[0085] The surgeon rotates the handle 362 of the operating unit 360 of the stapler 300 around the rotation axis 363 to project the annular blade of the punching unit 350. Then, a part of the oral side A1 of the large intestine, which is sandwiched between the first engaging instrument 310 and the second engaging instrument 370, the radially inner side of the mesh member 10, and a part of the anal side A2 of the large intestine are excised, and the periphery of the excised area is joined in a substantially annular shape with staples (not shown) (S105).
[0086] Next, as shown in Fig. 17, the surgeon removes the stapler 300 from the anal side A2 of the large intestine, for example, via the anus, to the outside of the living body. At this time, the region of the first engaging instrument 310 that is located inward of the outer diameter d of the punching portion 350 is removed together with the stapler 300 to the outside of the living body. As a result, the portion of the medical instrument 100 that is located radially inward of the punching portion 350 is removed without remaining in the living body. As a result, the mesh member 10 is formed from a substantially circular shape into an annular shape.
[0087] By sandwiching and placing the mesh member 10 of the medical device 100 between the biological organs to be joined, the through-holes A21 of the mesh member 10 can promote the healing of the biological organs to be joined.
[0088] According to this treatment method, the risk of suture failure after an anastomosis procedure (e.g., anastomosis of the digestive tract) can be reduced by the simple method of sandwiching a sheet-like mesh member 10 between the first and second joining areas.
[0089] As described above, the medical device 100 according to this embodiment comprises a mesh member 10 and a joint 20. The mesh member 10 is placed between biological organs to be anastomosed, is flat, has a plurality of through-holes 11 formed therein, and comprises first portions 12, 13 and second portions 14, 15. The joint 20 joins the biological organ and the mesh member 10 with staples. The mesh member 10 has a substantially arc-shaped portion that corresponds to the anastomosis site of the biological organ. The medical device 100 can also constitute a medical system 1 together with a stapler 200 that forms a cut site in the biological organ and sutures the cut site.
[0090] With this configuration, the first parts 12, 13 and the second parts 14, 15 other than the joint 20 can be applied so as to fit the cut site of the biological organ cut by the stapler 200. Therefore, when cutting the biological organ to be anastomosed before anastomosis, the sheet-like mesh member 10 can be efficiently positioned at the cut site.
[0091] The medical device 100 also includes a fixing portion 30 that fixes the mesh member 10 in a reduced dimension in the planar direction. The insertion path for inserting the stapler 200 and the medical device 100 is relatively narrow. Therefore, by reducing the dimension of the sheet-like mesh member 10 with the fixing portion 30, it becomes easier to insert the stapler 200 integrated with the medical device 100 into the abdominal cavity than when the medical device 100 is inserted together with the stapler 200 while kept spread out.
[0092] Furthermore, the mesh member 10 can be inserted into the body in a state where its dimensions have been reduced by the fixing part 30, and can be temporarily integrated with the stapler 200 that forms a cut site in the biological organ and sutures the cut site. This allows the medical device 100 to be positioned near the cut site when the biological organ is cut by the cutting part 212 of the stapler 200, and allows the mesh member 10 to be efficiently positioned at the cut site when the cut site is formed in the biological organ.
[0093] Furthermore, the mesh member 10 can be applied to an anastomotic site of a living organ to promote healing of the anastomotic site, thereby promoting healing of a site where a cancer or other lesion has been removed.
[0094] Furthermore, mesh member 10 includes reinforcing portions 16 and 17 that reinforce the expansion of mesh member 10 in the planar direction from a state in which the size in the planar direction has been reduced. This makes it easier to expand mesh member 10 from a reduced size state into a flat shape, and mesh member 10 can be placed in the area where healing is desired with minimal twisting or overlapping, thereby effectively promoting healing.
[0095] Furthermore, the fixing portion 30 is configured to include a long linear member that restricts the shape of at least a portion of the mesh member 10 so as to reduce the dimension in the planar direction of the mesh member 10. This makes it easier to reduce the dimension of the mesh member 10 so that it can be easily inserted into the abdominal cavity.
[0096] Furthermore, the linear members of the fixing portion 30 are cuttable, and the mesh member 10 is configured to be expandable from a reduced size by cutting the linear members. Therefore, the mesh member 10 can be formed into a shape that is easy to apply to the cut area by the relatively simple operation of cutting the linear members of the fixing portion 30. Furthermore, because the linear members are cuttable, the mesh member 10 can be expanded from a reduced size, and twisting of the mesh member 10 can be prevented or suppressed.
[0097] (Modification 1 of the first embodiment) Fig. 18 is a diagram showing a mesh member 10a of a medical device 100a according to a first modification of the first embodiment, and Fig. 19 is a diagram showing a state in which linear members according to the fixing portion 30 are arranged on the mesh member 10a according to Fig. 18. In the first embodiment, it has been described that the mesh member 10 is configured to connect first circular portions 12 and 13 and second circular portions 14 and 15.
[0098] However, the specific aspects of the first and second parts are not limited to those of the first embodiment, as long as the mesh member 10 can be applied to the cutting area by the cutting operation using the stapler 200. In addition to the above, for example, the mesh member 10a may be configured such that the substantially circular first parts 12 and 13 and the substantially circular second parts 14 and 15 are not connected to each other, as shown in Figure 18.
[0099] Other configurations of the medical device 100a, the staplers 200, 300, and the treatment method using the medical device 100a are the same as those in the first embodiment. For example, the mesh member 10a can also be provided with reinforcing portions 16, 17, as in the first embodiment. Therefore, detailed description of the common configurations will be omitted.
[0100] (Modification 2 of the first embodiment) Fig. 20 is a diagram showing a mesh member 10b constituting a medical device 100b according to Modification 2 of the first embodiment, Fig. 21 is a diagram showing a state in which linear members relating to fixing portions 30b are arranged on the mesh member 10b, and Fig. 22 is a diagram showing a state in which the mesh member 10b is spread out on a stapler 200.
[0101] In the first embodiment, the first portions 12, 13 and the second portions 14, 15 of the mesh member 10 are arranged at both ends of the stapler 200 in the width direction Y, but the mesh member can also be configured as follows: In this modified example, the staplers 200, 300 are the same as those in the first embodiment, so their description will be omitted.
[0102] As shown in Fig. 21 etc., the medical device 100b includes a mesh member 10b, a joint 20b, and a fixing portion 30b. As shown in Fig. 20, the mesh member 10b has a first portion 12 and a second portion 14 in the shape before being cut by the stapler 200. In this modification, the mesh member 10b is configured so that the first portion 12 and the second portion 14 are connected by the joint 20b.
[0103] That is, in this modified example, mesh member 10b is configured to be connected by joining portions 20b before joining by staples of stapler 200. In this modified example, mesh member 10b is arranged only on one side in the width direction Y of stapler 200, i.e., only on one side such as the anus side A2 described in the first embodiment, as shown in Fig. 22. Also in this modified example, reinforcing portions 16, 17 can be provided on mesh member 10b.
[0104] The mesh member 10b can be integrated with the stapler 200 in a zigzag or other folded state, as in the first embodiment. When the mesh member 10b is cut by the cutting section 212, it can be expanded from its reduced size and deformed so that the first portion 12 and the second portion 14 face in different directions (see FIG. 22).
[0105] The fixing portion 30b is configured to integrate the first portion 12 and the second portion 14 connected by the joint portion 20b with the first clamping portion 210 or the second clamping portion 220 of the stapler 200 in a folded state.
[0106] In a treatment method using the medical instrument 100b of this modification, the mesh member 10b is arranged on one side of the stapler 200 in the width direction Y (see FIG. 22 ) and is integrated with the stapler 200. When the stapler 200 cuts the mesh member 10b, the linear members of the fixing portion 30b are cut, and the first portion 12 and the second portion 14 are deployed in different directions. As a result, the mesh member 10b is applied so as to cover the cut area on the anal side A2 of the intestinal tract. The mesh member 10b is not arranged on the oral side A1 of the intestinal tract. Since the rest of the method is the same as in the first embodiment, a description thereof will be omitted. When the reduced-sized mesh member 10b integrated with the stapler 200 is inserted into the body and deployed, the linear members associated with the fixing portion 30b may be removed with forceps or the like, as necessary.
[0107] As described above, in this modified example, the mesh member 10b of the medical device 100b is disposed on only one side of the stapler 200 in the width direction Y. Even in this case, if the mesh member 10b and the stapler 200 are integrated so that the mesh member 10b is disposed on the side of the cutting area opposite the area to be excised, the mesh member 10b can be efficiently disposed at the cutting area after cutting by the stapler 200.
[0108] (Modification 3 of the first embodiment) Fig. 23 is a diagram showing mesh member 10c constituting medical device 100c, Fig. 24 is a diagram showing a state in which linear members relating to fixing portion 30c are arranged on mesh member 10c, and Fig. 25 is a diagram showing a state in which mesh member 10c is spread out on stapler 200. In the first embodiment, mesh member 10 is constituted by connecting substantially circular first portions 12, 13 and circular second portions 14, 15, but mesh member 10c can also be constituted as follows. Note that staplers 200, 300 are the same as those in the first embodiment, and therefore description thereof will be omitted.
[0109] 24, the medical device 100c includes a mesh member 10c, a joint 20, and a fixing portion 30c. The mesh member 10c includes a first portion 12 and a second portion 14. In Modification 2, when joint 20b is used as the reference, the first portion 12 is positioned opposite joint 20b with respect to the second portion 14.
[0110] 23 and 24, mesh member 10c is arranged so that first portion 12 and second portion 14 are aligned in the extending direction of joint 20. In this modification, mesh member 10c can also be provided with reinforcing portions 16 and 17, as in the first embodiment.
[0111] The joint portion 20 is configured to connect the first portion 12 and the second portion 14 by being formed in a strip shape.
[0112] The fixing portion 30c includes a linear member as in the first embodiment, and as an example, is wound around and integrated with the outer periphery in the width direction Y of the first clamping portion 210 of the stapler 200 with the dimension of the first portion 12 in the planar direction reduced. The fixing portion 30c is configured to be wound around and integrated with the outer periphery in the width direction Y of the second clamping portion 220 of the stapler 200 with the dimension of the second portion 14 in the planar direction reduced.
[0113] In a treatment method using a medical instrument 100c according to this modification, the first portion 12 and the second portion 14 are arranged to protrude from only one side of the stapler 200 in the width direction Y, as in modification 2, and are integrated with the stapler 200 (see FIG. 25). When a portion of a biological organ is cut and sutured with the stapler 200, the first portion 12 and the second portion 14 are joined by the joining portion 20 to form a substantially circular shape and sutured to the biological organ, and the first portion 12 and the second portion 14 are applied so as to cover the cut site. In this modification, as in modification 2, a mesh member 10c is not placed at the cut site on the mouth side A1. As the rest is the same as in the first embodiment, a description thereof will be omitted.
[0114] As described above, in this modified example, the first portion 12 and the second portion 14 are arranged side by side along the joint portion 20. Even when the mesh member 10c is arranged on only one side of the cutting site in this manner, as in modified example 2, by arranging the mesh member 10c on the cutting site opposite the side to be excised, the mesh member 10c can be efficiently arranged on the cutting site after cutting with the stapler 200.
[0115] (Fourth modification of the first embodiment) FIG. 26 shows a modified example of a reinforcing portion in either the first or second portion of mesh member 10d constituting the medical device (although first portion 12 is shown as an example in the drawing, the same applies to other portions). In the first embodiment, the two intersections of the wide arc-shaped and band-shaped portions in first portions 12 and 13 are referred to as joints 20, and the connecting portion between joints 20 is referred to as reinforcing portion 16. However, reinforcing portion 16d may have a notch Nd at the connecting portion between joints 20, taking into consideration that it will be inserted through shaft 410 of second engaging device 370 of stapler 300 (see hatched portion in FIG. 26). Note that the specifications of reinforcing portion 16d can be similarly provided not only in first portions 12 and 13 but also in second portions 14 and 15. The configuration of the mesh member 10d other than the reinforcing portion 16d, the joining portion 20, the fixing portion 30, and the treatment method using the staplers 200, 300 and medical instruments are the same as those in the first embodiment, so a description of the common configuration will be omitted.
[0116] (Fifth Modification of the First Embodiment) FIG. 27 shows a modified example of the reinforcement portion of the mesh member 10e constituting the medical device. In the first embodiment, the two intersections of the thick arc-shaped and band-shaped portions in the first portions 12 and 13 are referred to as joints 20, the connecting portions between the joints 20 are referred to as reinforcement portions 16, and the portion radially inward from the inner side ch of the thick arc-shaped portions of the first portions 12 and 13 is referred to as reinforcement portion 17. However, in this modified example, the reinforcement portion may be configured as a cutout portion Ne without a portion corresponding to reinforcement portion 16, as shown in FIG. 27 . Note that the configuration of the mesh member 10e other than the reinforcement portion, the joints 20, the fixing portion 30, the staplers 200 and 300, and the treatment method using the medical device are the same as those in the first embodiment. Therefore, a description of the common configuration will be omitted.
[0117] (Modification 6 of the first embodiment) 28 is a diagram showing a modified example of a reinforcing portion of a mesh member 10f constituting a medical device. In the fourth modified example of the first embodiment, the two intersections of the thick circumferential shape and the band shape of the first portions 12, 13 are referred to as joints 20, and it has been explained that a notch Nd through which the shaft 410 can be inserted is provided in the reinforcing portion 16d, which is the connecting portion between the joints 20. Also, in the first embodiment, it has been explained that the portion radially inward from the inner side ch of the thick arc shape of the first portions 12, 13 is referred to as the reinforcing portion 17.
[0118] In this modified example, the reinforcing portion may be configured as a notch portion Nf, as shown in Fig. 28, by providing the reinforcing portion 16d shown in Fig. 26, instead of providing a portion corresponding to the reinforcing portion 17 of the first embodiment. Note that the configuration of the mesh member 10f other than the reinforcing portion, the joining portion 20, the fixing portion 30, and the treatment method using the staplers 200, 300 and medical instruments are the same as those in the first embodiment. Therefore, a description of the common configuration will be omitted.
[0119] (Modifications 7, 8, and 9 of the first embodiment) 29, 30, and 31 are diagrams showing ways in which the dimensions of the mesh member 10 in the planar direction are reduced when the mesh member 10 is integrated with the stapler 200. In the first embodiment, it has been described that the dimensions in the planar direction are reduced by deforming the sheet-like mesh member 10 so as to fold it in a zigzag pattern in the width direction Y of the stapler 200, but the specific way in which the dimensions of the mesh member are reduced is not limited to a zigzag pattern as long as the shape of the mesh member can be made smaller than a completely flat shape when the stapler 200 is inserted into the abdominal cavity.
[0120] In addition to the above, as shown in Figure 29 showing variant example 7, the mesh member 10 may be configured to be wrapped around the outer periphery of the stapler 200 when the first clamping portion 210 or the second clamping portion 220 of the stapler 200 is viewed from the longitudinal direction X.
[0121] Furthermore, as shown in Figure 30 showing variant example 8, the mesh member 10 may be wound so as to form a spiral on the side of the first clamping section 210 or the second clamping section 220 on which the mesh member 10 is arranged in the height direction Z.
[0122] Furthermore, as shown in Figure 31 for variant example 9, in contrast to variant example 8, the mesh member 10 may be wound so that a spiral is formed in the direction opposite to the first clamping section 210 or the second clamping section 220 in which the mesh member 10 is arranged in the height direction Z.
[0123] The treatment methods using the medical instruments according to variants 7, 8, and 9 have in common the fact that the linear member of the fixing portion 30 is wound around the first clamping portion 210 or the second clamping portion 220 so as to pass through the plane between the first clamping portion 210 and the second clamping portion 220 when viewed from the longitudinal direction X.
[0124] As a result, when the cutting portion 212 of the stapler 200 cuts the living organ, the linear members of the fixing portion 30 can be cut, and the mesh member 10 can be deformed so as to expand into a flattened shape from any of the shapes shown in Figures 29, 30, and 31. Since the rest is the same as in the first embodiment, a description thereof will be omitted.
[0125] (Modification 10 of the first embodiment) 32 to 34 are diagrams illustrating the integration of mesh member 10 according to modified example 10 of the first embodiment with stapler 200. In the first embodiment, by winding the linear member associated with fixing portion 30 around first clamping portion 210 or second clamping portion 220, mesh member 10 is integrated with stapler 200 with its dimensions reduced in the planar direction.
[0126] In addition to this, the mesh member 10 and the stapler 200 may be integrated together by providing a removable adhesive s at the contact portion between the first clamping portion 210 and the second clamping portion 220 and the mesh member 10, as shown in Fig. 32. The adhesive strength of such adhesive s can be adjusted to such an extent that the mesh member 10 is peeled off from the stapler 200 when the stapler 200 is removed from the intestinal tract after the living organ is cut by the cutting portion 212 of the stapler 200.
[0127] In addition to the adhesive s, a slit t may be provided at the contact portion between the mesh member 10 and the stapler 200 to fix the mesh member 10 to the stapler 200 and to serve as a starting point for detaching the mesh member 10 from the stapler 200 by a certain operation (see Figure 34). The slit t can be fixed to the stapler 200 with an adhesive, tape, or the like. The material of the slit t may be a bioabsorbable material or a non-bioabsorbable material.
[0128] The slit t is set to have a strength weaker than the fixing force between the mesh member 10 and the intestinal tract, and can be formed by a slit, a dotted line, or a weak material as shown in FIG. 34 . The slit t can be set so that when the cutting portion 212 of the stapler 200 cuts the living organ and the stapler 200 is removed from the intestinal tract, the slit t is cut and the fixing portion 30 and the mesh member 10 are separated. The slit t may be provided over the entire surface of the stapler 200, such as at the end portion in the longitudinal direction X, or may be provided only in a portion thereof. The slit t is provided at the end and base of the overlapping portion of the first clamping portion 210 and the second clamping portion 220 of the stapler 200, at the portion of the mesh member 10 punched by the punching portion 350, and on the side surface of the stapler 200. The adhesive s can be provided at the portion of the mesh member 10 punched by the punching portion 350 and on the side surface of the stapler 200. The adhesive s can also be applied near the center of the semicircular portions of the first portions 12 and 13 and the second portions 14 and 15 of the mesh member 10.
[0129] Other configurations of the mesh member 10, the joining portion 20, the fixing portion 30 and the stapler 200 other than the adhesive s and the slit t in this modified example, and the stapler 300 are the same as those in the first embodiment. Also, the treatment method involves using the adhesive s to integrate the mesh member 10 with the stapler 200, and detaching the mesh member 10 from the stapler 200 along the slit t after cutting the living organ with the stapler 200, and therefore will not be described here.
[0130] (Modification 11 of the first embodiment) 35, 36, and 37 are diagrams illustrating an eleventh modification of the first embodiment. In the first embodiment, it was explained that the mesh member 10 is unfolded from a state in which its dimension in the planar direction is reduced by cutting the linear members associated with the fixing portions 30, but the manner in which the mesh member is unfolded from a state in which its dimension in the planar direction is reduced can be configured as follows. Note that Figs. 35 to 37 show either the first portions 12, 13 or the second portions 14, 15 of the mesh member 10k.
[0131] In this modified example, in addition to the mesh member 10k, the joints 20, and the fixing portions 30, there are also provided swelling portions 40 and threads 50. Although the mesh member 10k does not have the reinforcing portions 16, 17, the configurations of the joints 20, the fixing portions 30, and the staplers 200, 300 other than the mesh member 10k, the swelling portions 40, and the threads 50 are the same as those in the first embodiment, and therefore description thereof will be omitted.
[0132] As shown in Fig. 35, the swelling portion 40 is configured so that a tube member is provided on the outer periphery of the mesh member 10k. The tube member of the swelling portion 40 is configured so as to have an injection port (not shown) through which a fluid can be injected. One tube member of the swelling portion 40 is provided on the outer periphery of each of the first portions 12, 13 and the second portions 14, 15. A thread 50 is used to sew the tube member of the swelling portion 40 to the mesh member 10k and connect it thereto, and then to tie it to the mesh member 10k to secure it in place.
[0133] The fluid filling the internal space of the tubular member of the swelling portion 40 can be a liquid such as water or saline, or a gas. The material of the tubular member of the swelling portion 40 is preferably a flexible, inelastic material so that it can maintain its folded state before expansion. The tubular member of the swelling portion 40 can be fastened to the mesh member 10k with thread or a strip-like member, or can be integrated with the mesh member 10k using a removable adhesive. The material integrating the tubular member of the swelling portion 40 with the mesh member 10k is preferably, but not necessarily, a bioabsorbable material. In addition, while the tubular member of the swelling portion 40 is shown in FIG. 35 as being provided around the entire outer periphery of the first portions 12, 13, and the second portions 14, 15, this is not limiting and the tubular member may be partially disposed around the first portions 12, 13, and the second portions 14, 15.
[0134] <Treatment method> The treatment method using the medical instrument of this modified example is the same as that of the first embodiment, up to cutting and joining of the biological organ with the stapler 200, removing the stapler 200 from the abdominal cavity, and removing the cancerous part, etc., and therefore will not be described here.
[0135] After removing one of the cut sites, the surgeon injects fluid through the injection port of the tubular member of the ampulla 40 to expand the tubular member of the ampulla 40 before the staples are released by the release unit 340 of the stapler 300. The expansion of the mesh member 10k is promoted by the expansion of the tubular member of the ampulla 40 with the linear members of the fixing unit 30 cut, allowing the mesh member 10k to be placed in a more appropriate state at the site to be healed. After the expansion of the tubular member of the ampulla 40 is complete, the surgeon removes the instrument used to expand the tubular member of the ampulla 40 from the abdominal cavity. The subsequent operations are the same as those in the first embodiment, and therefore will not be described further.
[0136] It has been explained above that an internal space for accommodating a fluid is provided in the tube member of the swelling portion 40, and filling the internal space with a fluid causes the tube member of the swelling portion 40 to expand, thereby facilitating the deployment of the mesh member 10k. However, the promotion of the deployment of the mesh member 10k is not limited to this. In addition to the above, the tube member may be substituted by placing a swellable gel or beads in a permeable membrane tube, and the tube member may be expanded by contacting it with water, physiological saline, or water present in a living organ, thereby facilitating the deployment of the mesh member 10k.
[0137] The tube member may also be configured to memorize the shape in which mesh member 10k is deployed and restore the memorized shape when triggered by heat, etc. The tube member may also include an elastic member, the elasticity of which is suppressed until the linear member associated with fixing portion 30 is cut, and the tube member of expanding portion 40 may promote the mesh member 10k to deploy when the elastic force is restored by cutting the linear member.
[0138] Furthermore, the arrangement of the tubular member of the swelling portion 40m is not limited to the outer periphery of the mesh member 10k. As shown in FIGS. 36 and 37, the expansion of the mesh member 10k may be promoted with the tubular member of the swelling portion 40m arranged on the inner periphery of the mesh member 10k. In FIG. 36, the mesh member 10k extends approximately in the depth direction of the page. By expanding the swelling portion 40, the mesh member 10k deforms to conform roughly to the page, as shown in FIG. 37. In this case, the tubular material and the mesh member 10k can be integrated with each other using adhesive or by tying them to the mesh member 10k with thread, strips, or the like. Such materials may be made of either bioabsorbable or non-bioabsorbable materials.
[0139] (Modification 12 of the first embodiment) Fig. 38 is a diagram showing a state in which mesh member 10p is integrated with stapler 200p, Fig. 39 is a diagram showing a state in which mesh member 10p is unfolded from the integrated state, and Fig. 40 is a diagram showing how mesh member 10p is wound around stapler 200p when integrating mesh member 10p with stapler 200p.
[0140] In the first embodiment, it was explained that the mesh member 10 is integrated with the stapler 200 by wrapping the linear member of the fixing portion 30 around each of the first clamping portion 210 and the second clamping portion 220 of the stapler 200 and the mesh member 10, but the mesh member 10 can be integrated with and released from the first clamping portion 210 that houses the cutter as follows.
[0141] In this modified example, the mesh member 10p constituting the medical device 100p differs only in the way the mesh member 10p is wrapped around the first clamping portion 210p and the way the linear member of the fixing portion 30p is inserted through the mesh member 10p. The rest of the medical device is the same as that of the first embodiment. Furthermore, the second clamping portion 220, operating portion 230, and stapler 300 of the stapler 200p are the same as those of the first embodiment, and therefore their description will be omitted. Thus, in this modified example, the first clamping portion 210 and the second clamping portion 220 have different fixing portion configurations. For ease of explanation, the first clamping portion 210p and the second clamping portion 220 are shown upside down in FIGS. 38 to 40 compared to the other drawings.
[0142] The first clamping unit 210p of the stapler 200p includes a discharge hole 211 for discharging staples, a cutting unit 212p for cutting a living organ as shown in FIG. 38, and a groove 213p. As in the first embodiment, the discharge hole 211 is configured to be able to discharge staples toward the second clamping unit 220. The cutting unit 212p is disposed near the groove 213p and is configured to be able to move along the groove 213p. A mesh member 10p integrated with the first clamping unit 210p can be disposed so as to be wound around the groove 213p (see FIGS. 38 and 40). The mesh member 10p is held integrally with the first clamping unit 210 by having a fixing portion 30p pierce one portion of the mesh member 10p that overlaps the first clamping unit 210 when its dimension in the planar direction is reduced. As shown in FIG. 38, the linear member of the fixing portion 30p is disposed in the groove 213p so as to be positioned, for example, a predetermined distance inside the groove 213p at an end portion near the movement start position of the cutting portion 212p. From a position a predetermined distance from the end of the groove 213p to an end portion near the movement end position of the cutting portion 212p, the linear member of the fixing portion 30p leaves the inside of the groove 213p and is disposed outside the first clamping portion 210p so as to be along the groove 213p of the first clamping portion 210p. Furthermore, the linear member of the fixing portion 30p is inserted so as to be unwound (pushed out) from the mesh member 10 as the cutting portion 212p moves in the longitudinal direction X. One end portion of the linear member of the fixing portion 30p is fixed to the cutting portion 212p so as to be interlocked with the movement of the cutting portion 212p. The linear member of the fixing portion 30p is preferably formed with a thick, flat end on the side opposite the direction of travel of the cutting portion 212p to make it easier to push with the cutting portion 212p. The linear member of the fixing portion 30p is preferably made of a hard, non-absorbent material such as resin or metal, but an absorbent material may also be used. In addition, in the second clamping portion 220, the mesh member 10 is configured to be integrated with the second clamping portion 220 by the linear member of the fixing portion 30, as in the first embodiment (see FIG. 11).
[0143] <Treatment method> Next, a treatment method according to this modification will be described. The formation of a port in the patient is the same as in the first embodiment. Next, the surgeon reduces the dimensions of the mesh member 10 and integrates the mesh member 10 with the stapler 200p using the fixing portions 30, 30p. The integration of the second clamping portion 220 and the mesh member 10 in the stapler 200p is the same as in the first embodiment.
[0144] Regarding the integration of the first clamping portion 210p and the mesh member 10, as described above, a linear member is attached to the cutting portion 212p and inserted into the mesh member 10 so that the thread-like member associated with the fixing portion 30p is pushed out of the mesh member 10 as the cutting portion 212p moves.
[0145] The next steps, which include forming an incision, inserting the stapler 200 into the body, and clamping the cut area with the stapler 200, are the same as in the first embodiment. Next, the surgeon operates the operating unit 230 to release staples from the first clamping unit 210p and cut the cut area with the cutting unit 212p. At this time, a cut area is formed at the cut area by the cutting unit 212p, and the periphery of the cut area is sutured with the staples. Furthermore, as the cutting unit 212p moves, the linear members that had been integrating the mesh member 10p with the first clamping unit 210p are pushed out from the first clamping unit 210p, thereby releasing the integration of the mesh member 10p with the first clamping unit 210p, and the mesh member 10p deforms (expands) from its small size to a flat shape (see FIG. 39). The mesh member 10p is formed into a substantially circular shape by the joining unit 20. The thread-like member associated with the fixing portion 30p may be removed from the first clamping portion 210 using a tool such as forceps, if necessary.
[0146] The process of releasing the integration of the second clamping portion 220 and the mesh member 10p is the same as in the first embodiment. As a result, the mesh member 10p is separated from the stapler 200, and the mesh member 10 in which the first portions 12, 13 and the second portions 14, 15 are integrated by the joints 20 is positioned on the mouth side A1 and the anus side A2, which are the ends of the cutting area. The subsequent operations are the same as in the first embodiment, so a description thereof will be omitted.
[0147] As described above, in this modified example, the mesh member 10p is integrated with the first clamping portion 210p of the stapler 200p by inserting a linear member through the mesh member 10p arranged around the first clamping portion 210p. The linear member that integrates the first clamping portion 210p and the mesh member 10p is pushed out from the first clamping portion 210p as the cutting portion 212p moves, and the mesh member 10p unfolds from its small size. With this configuration, the integration of the mesh member 10p and the first clamping portion 210p can be released by the normal operation of forming a cut portion with the cutting portion 212p of the stapler 200p.
[0148] (Second embodiment) 41 is a diagram showing the time when the dimension in the planar direction of the medical device 100q according to the second embodiment is reduced and integrated with the stapler 200. In the first embodiment, it has been described that the fixing unit 30 reduces the dimension in the planar direction of the mesh member 10 by winding a linear member such as a thread around the mesh member 10 and either the first clamping unit 210 or the second clamping unit 220, and that the mesh member 10, whose dimension has been reduced by cutting the linear member, is expanded into a flat shape, but the configuration of the fixing unit is not limited to the above.
[0149] The fixing portion can be configured as follows: In this embodiment, the mesh member 10, the joint portion 20, and the staplers 200 and 300 that constitute the medical device 100q are configured in the same manner as in the first embodiment, and therefore a description of the common configuration will be omitted.
[0150] In this embodiment, the fixing portion 30q constituting the medical device 100q is configured to be attachable to and detachable from the stapler 200 as shown in Fig. 41. The fixing portion 30q is configured to be attached to the first clamping portion 210 or the second clamping portion 220 of the stapler 200 together with the mesh member 10, thereby reducing the dimension of the mesh member 10 in the planar direction. In this embodiment, the fixing portion 30q comprises a tubular attachment member that has a bottom surface on one side and an open side, like a cap shown in Fig. 41. By removing the fixing portion 30q from the stapler 200, the mesh member 10 can be expanded into a flat shape.
[0151] The fixing portion 30q can attach a mesh member 10 with a reduced surface dimension and either the first clamping portion 210 or the second clamping portion 220 to the opening. The area of the bottom surface of the fixing portion 30q, as viewed in the longitudinal direction X, is slightly larger than that of the first clamping portion 210, etc., so that the mesh member 10 does not unfold when either the first clamping portion 210 or the second clamping portion 220 and the mesh member 10 are inserted into the fixing portion 30q. The fixing portion 30q can be made of an elastic material, which may or may not be bioabsorbable. The attachment member for the fixing portion 30q is formed as a bottomed recess as described above, and the elasticity of the member secures the mesh member 10 in a reduced-size state when attached. The attachment member for the fixing portion 30q can be installed at the end of the mesh member 10.
[0152] <Treatment method> Next, a treatment method according to this embodiment will be described. The formation of a port in the patient's abdomen is the same as in the first embodiment. Next, the surgeon integrates the mesh member 10 and the first clamping portion 210 of the stapler 200 using the attachment member of the fixing portion 30q while reducing the dimension of the mesh member 10 in the planar direction. The surgeon performs a similar operation on the second clamping portion 220.
[0153] The subsequent steps of forming an incision in the abdomen and inserting the stapler 200 integrated with the mesh member 10 into the abdominal cavity are the same as those in the first embodiment. Next, the surgeon uses an instrument such as forceps to remove the attachment member of the fixing portion 30q from the stapler 200. This releases the mesh member 10 from its small size and its integration with the first clamping portion 210 or the second clamping portion 220, and the mesh member 10 deforms so as to unfold in the planar direction. The attachment member of the fixing portion 30q can be removed from the mesh member 10 using the forceps after the stapler 200 is inserted into the abdominal cavity and before punching by the punching portion 350. The subsequent procedures are the same as those in the first embodiment, so a description thereof will be omitted.
[0154] As described above, fixing portion 30q is attachable to and detachable from stapler 200, and includes an attachment member that restricts the shape of at least a portion of mesh member 10 so as to reduce the dimensions of mesh member 10. Mesh member 10 is configured to reduce in size when attached to stapler 200 by the attachment member of fixing portion 30q, and can be expanded from the reduced size state to a flat shape by removing mesh member 10 from stapler 200.
[0155] In this way, the dimensions of the mesh member 10 can be reduced or expanded by the relatively simple operation of attaching and detaching the fixing portion 30q to the first clamping portion 210 or the second clamping portion 220.
[0156] (Modification 1 of the second embodiment) 42 is a diagram showing the fixing portion 30r of the medical device 100r according to Modification 1 of the second embodiment. In the second embodiment, the fixing portion 30r is described as having a cap-like attachment member with a bottom surface on one side and an open surface on the other, but the fixing portion 30r may also be configured as follows. Note that in this modification, the mesh member 10, joint portion 20, and staplers 200 and 300 that make up the medical device 100r are the same as those in the first embodiment, and therefore description thereof will be omitted.
[0157] In this modified example, the fixing portion 30r has a shape in which a portion of an annular member such as a ring is cut out in the circumferential direction as an attachment member, as shown in Fig. 42. In other words, the fixing portion 30r is configured to have a shape resembling the letter C. The fixing portion 30r maintains the reduced size of the mesh member 10 by arranging either the first clamping portion 210 or the second clamping portion 220 and the mesh member 10 inside the shape in which a portion of the annular member is cut out as described above.
[0158] The attachment member of the fixing portion 30r can be removed from either the first clamping portion 210 or the second clamping portion 220 and the mesh member 10 to expand the mesh member 10 from its reduced size to a flat shape. The attachment member of the fixing portion 30r can be configured to include an elastic material, which may or may not be a bioabsorbable material. The attachment member of the fixing portion 30r maintains the reduced size of the mesh member 10 due to its elasticity when attached to the mesh member 10. The attachment member of the fixing portion 30r can be installed in one or more locations on the mesh member 10, as in the second embodiment, as long as the mesh member 10 can be positioned inside the C-shape.
[0159] The treatment method using the stapler 200 differs from the second embodiment in that the attachment member for the fixed portion 30r is used instead of the attachment member for the fixed portion 30q, and therefore the description thereof will be omitted.
[0160] As described above, in this modified example, the attachment member associated with the fixing portion 30r has a shape in which a portion of the annular member is missing in the circumferential direction. The attachment member associated with the fixing portion 30r clamps the mesh member 10 with either the first clamping portion 210 or the second clamping portion 220 inside the annular member, thereby reducing the size of the mesh member 10. In addition, the mesh member 10 can be expanded from its reduced size into a flattened shape by removing the stapler 200 and the mesh member 10 from the annular member of the fixing portion 30r.
[0161] In this way, by the relatively simple operation of attaching and detaching the annular member of the fixing portion 30r to the stapler 200 and the mesh member 10, the dimensions of the mesh member 10 can be reduced or expanded into a flat shape, as in the second embodiment.
[0162] (Modification 2 of the second embodiment) FIG. 43 is a diagram showing a state in which the size of the mesh member 10 in the planar direction is reduced by the fixing portion 30s of the medical device 100s according to Modification 2 of the second embodiment. In Modification 1 of the second embodiment, the mesh member 10 is integrated with the stapler 200 and its size is reduced by using an annular member with a portion of its circumferential shape cut out. However, the fixing portion 30s may also be configured as follows. In this modification, the fixing portion 30s may be configured to include a clip-like member having a starting point P1 and a pair of arms 31s that open and close from P1, as shown in FIG. 43 . The attachment member of the fixing portion 30s can clamp or release the mesh member 10 with either the first clamping portion 210 or the second clamping portion 220 by widening or narrowing the gap between the pair of arms 31s. The clip-like member of the fixing portion 30s is configured to include a relatively hard material. This hard material may or may not be bioabsorbable. The attachment member for the fixing portion 30s can be installed at one or more locations on the mesh member 10.
[0163] The configuration of the medical device 100s according to this modification is the same as that of the first embodiment except for the fixing portion 30s, and the treatment method using the medical device 100s differs from that according to the second embodiment in that the fixing member for the fixing portion 30s is used instead of the fixing member for the fixing portion 30q. Therefore, a description thereof will be omitted.
[0164] As described above, in this modified example, the attachment member for the fixing portion 30s has a starting point P1 and is configured to have a pair of arms 31s that can be opened and closed from the starting point P1. This allows the pair of arms 31s to clamp the mesh member 10 with either the first clamping portion 210 or the second clamping portion 220, thereby reducing the dimension of the mesh member 10 in the planar direction, and releasing the clamping allows the mesh member 10 to be unfolded into a flat shape.
[0165] (Modification 3 of the second embodiment) Figure 44 is a diagram showing a state in which the dimensions of the mesh member 10 are reduced by the fixing portion 30t of the medical device 100t relating to variant example 3 of the second embodiment, and Figure 45 is a diagram showing a state in which the fixing portion 30t shown in Figure 44 has been removed from the mesh member 10.
[0166] In the second embodiment and variants 1 and 2 of the second embodiment, it has been explained that the mounting members of the fixed portions 30q, 30r, and 30s are attached to either the first clamping portion 210 or the second clamping portion 220 together with the mesh member 10 to reduce the dimensions of the mesh member 10, but the mounting members of the fixed portions can also be configured as follows.
[0167] In this embodiment, the mesh member 10, the joint portion 20, and the staplers 200 and 300 that constitute the medical device 100t are configured in the same manner as in the first embodiment, and therefore a description of the common configuration will be omitted.
[0168] The fixing portion 30t constituting the medical device 100t includes a hook member formed in a substantially U-shape, a substantially C-shape, or a recessed portion as shown in Fig. 44. In this modification, the hook member of the fixing portion 30t is folded while the mesh member 10 is placed on the clamping surface of the first clamping portion 210 or the second clamping portion 220, thereby reducing the dimension in the planar direction. The hook member of the fixing portion 30t can be positioned so as to clamp the end of the bent arc portion of the mesh member 10 without coming into contact with the first clamping portion 210 or the second clamping portion 220.
[0169] This allows the mesh member 10 to be maintained in a reduced size state for a certain period of time, such as when the stapler 200 is inserted into the body from outside.
[0170] <Treatment method> Next, a treatment method using the medical device 100t according to this modification will be described. The formation of a port in the patient's abdomen is the same as in the first embodiment. Next, the surgeon folds the mesh member 10 from the state in which it is placed on the clamping surface of the stapler 200, and clamps the folded end with the hook members associated with the fixing portion 30t to maintain the reduced size of the mesh member 10. The surgeon performs this operation on both the first clamping portion 210 and the second clamping portion 220.
[0171] The subsequent steps of forming an incision in the abdomen and inserting the stapler 200 into the abdominal cavity are the same as in the first embodiment. Next, the surgeon uses an instrument such as forceps to remove the hook members associated with the fixing portions 30t from the mesh member 10 (see FIG. 45). This causes the mesh member 10 to unfold from its small size and transform into a flattened shape. The subsequent procedures are the same as in the first embodiment, so a description thereof will be omitted.
[0172] As described above, fixing portion 30t is not attached to stapler 200, but is configured to clamp the end portion of mesh member 10 that has been folded from a state in which it is placed on the clamping surface. As a result, by clamping mesh member 10 with the hook members of fixing portion 30t, the dimensions of mesh member 10 can be reduced, and by detaching the hook members from mesh member 10, mesh member 10 can be deformed (expanded) from a state in which the dimensions are reduced to a flat shape.
[0173] (Third embodiment) Figure 46 is a diagram showing the state in which the mesh member 10 is surrounded by the fixing portion 30v of the medical device 100v relating to the third embodiment, Figure 47 is a diagram showing the state in which the mesh member 10 is released from the surrounding by the fixing portion 30v, and Figure 48 is a diagram showing the fixing portion 30v.
[0174] In the second embodiment, it has been explained that the surgeon uses forceps or the like to remove the attachment members of the fixing portions 30q, 30r, 30s, and 30t from the mesh member 10 after the attachment members have been attached to the mesh member 10, but fixing portion 30v can also be configured as follows: Note that the staplers 200, 300, mesh member 10, and joining portion 20 are the same as those in the first embodiment, and therefore their description will be omitted.
[0175] In this embodiment, the fixed portion 30v includes a ring-shaped member, which includes ring portions 31v and 32v and a connecting portion 33v, as shown in FIG.
[0176] The ring portions 31v, 32v surround at least a portion of the mesh member 10 so as to reduce the dimensions of the mesh member 10. The ring portions 31v, 32v have an annular shape and are configured so as not to surround the mesh member 10 in an unfolded state (flattened shape), but to surround at least a portion of the mesh member 10 whose dimensions have been reduced by folding or the like. The ring portions 31v and 32v can surround each of the first portions 12, 13 integrated with the first clamping portion 210 and the second portions 14, 15 integrated with the second clamping portion 220 in their reduced dimensions. In Figure 46, for convenience of illustration, the ring-shaped member of the fixing portion 30v is inserted only into the first clamping portion 210, but the fixing portion 30v can be inserted into the second clamping portion 220 and the mesh member 10 while the dimensions of the mesh member 10 are reduced, thereby surrounding the reduced dimensions of the mesh member 10.
[0177] The ring portions 31v, 32v are configured so that the mesh member 10 can be released from its encirclement by inserting the ring portions 31v, 32v into the mesh member 10 whose dimensions have been reduced, and then sliding the fixing portion 30v in the longitudinal direction X as shown in Figure 47.
[0178] The connecting portion 33v connects the ring portion 31v and the ring portion 32v so that the distance between the ring portion 31v and the ring portion 32v does not exceed a certain value. The ring-shaped member of the fixing portion 30v can be formed in a shape such as a thread or ribbon, and can include a flexible absorbent or non-absorbent material. The ring member of the fixing portion 30v can be disposed near the end of the mesh member 10.
[0179] <Treatment method> Next, a treatment method using the medical instrument 100v according to this embodiment will be described. The formation of the ports is the same as in the first embodiment. Next, the surgeon maintains the reduced size of the mesh member 10 in the planar direction by inserting the ring portions 31v, 32v into either the first clamping portion 210 or the second clamping portion 220 and either the first portion 12, 13 and the second portion 14, 15 in a reduced size state of the mesh member 10. As a result, the mesh member 10 is integrated with the stapler 200 in a reduced size state as shown in FIG. 46.
[0180] Next, the surgeon forms an incision and inserts the stapler 200, with the first clamping portion 210 and the second clamping portion 220 closed, into the abdominal cavity. Next, the surgeon opens the first clamping portion 210 and the second clamping portion 220, and clamps the area to be cut with the first clamping portion 210 and the second clamping portion 220.
[0181] When the region to be cut is clamped by the first clamping unit 210 and the second clamping unit 220, the position of the ring-shaped member associated with the fixing unit 30v relative to the mesh member 10 can be slid and moved by pushing a biological organ such as the intestinal tract between the first clamping unit 210 and the second clamping unit 220. As a result, as shown in Figures 46 and 47, the ring portions 31v and 32v of the ring-shaped member associated with the fixing unit 30v can transition from a state in which they surround the mesh member 10 integrated with the first clamping unit 210 and the mesh member 10 integrated with the second clamping unit 220, respectively, to a state in which they do not surround them.
[0182] This releases the ring portions 31v and 32v from surrounding the mesh member 10, allowing the mesh member 10 to expand from its small size into a flat shape. Next, the surgeon operates the first clamping unit 210 to cut the large intestine with the cutting unit 212 and suture the periphery of the cut site with staples. As a result, the first portion 13 and the second portion 15 are integrated with the periphery of the cut site by the joint portion 20 to cover the cut site on the oral side A1, and the first portion 12 and the second portion 14 are integrated with the periphery of the cut site by the joint portion 20 to cover the cut site on the anal side A2. The rest of the process is the same as in the first embodiment, so a description thereof will be omitted.
[0183] As described above, in this embodiment, the fixing portion 30v includes a ring-shaped member. The ring-shaped member of the fixing portion 30v surrounds a portion of the mesh member 10 so as to reduce the dimensions of the mesh member 10, and the ring-shaped member of the fixing portion 30v slides from the portion where it surrounds at least a portion of the mesh member 10, thereby releasing the surrounding of the mesh member 10.
[0184] In this way, by linking the unfolding of the mesh member 10 to the normal operation of the stapler 200, such as clamping a biological organ with the first clamping portion 210 and the second clamping portion 220, the mesh member 10 can be unfolded from its reduced size without any special operation.
[0185] (Fourth embodiment) 49 is a diagram showing a medical instrument 100w according to a fourth embodiment. In the first embodiment, it has been described that the medical instrument 100 is integrated with the stapler 200 in a state in which the dimension in the planar direction is reduced by the fixing portion 30. However, the medical instrument 100w may not include the fixing portion 30, and the mesh member 10 may be clamped by the first clamping portion 210 and the second clamping portion 220, thereby maintaining the mesh member 10 in a reduced dimension in the planar direction.
[0186] That is, in the medical device 100w according to this embodiment, the mesh member 10 is clamped by the first clamping portion 210 and the second clamping portion 220 of the stapler 200 in a state in which it is folded in a zigzag pattern as shown in Fig. 42. The medical device 100w includes a mesh member 10 and a joint portion 20 (see Fig. 6). The mesh member 10 is configured so that, from a state in which it is clamped by the first clamping portion 210 and the second clamping portion 220, the mesh member 10 is shaped by twisting it by approximately 90 degrees around the portion clamped by the first clamping portion 210 and the second clamping portion 220.
[0187] This allows the mesh member 10 to change the unfolding direction by twisting it, making it easier for the unfolded mesh member 10 to fit along the end face of the cut portion after cutting.
[0188] <Treatment method> In the treatment method using the medical instrument 100w according to this embodiment, the formation of the port is the same as in Embodiment 1. Next, the surgeon twists the mesh member 10 as described above to reduce the dimension of the mesh member 10 in the planar direction, and then clamps the mesh member 10 between the first clamping portion 210 and the second clamping portion 220 to integrate it with the stapler 200.
[0189] Next, the surgeon makes an incision near the patient's navel and inserts the stapler 200, which holds the mesh member 10, into the abdominal cavity. Next, the surgeon opens the first clamping portion 210 and the second clamping portion 220. At this time, the mesh member 10 unfolds, and the twisting causes the mesh member 10 to deform so that it can easily fit along the end surface of the cut portion of the living organ after cutting. In this state, the surgeon operates the stapler 200 to release the staples and move the cutting portion 212 to form the cut portion, and then sutures the periphery of the cut portion together with the mesh member 10. The subsequent operations are the same as in the first embodiment, so a description thereof will be omitted.
[0190] As described above, in this embodiment, the medical device 100w is not provided with a fixing portion, and is shaped so that the mesh member 10 is twisted when clamped between the first clamping portion 210 and the second clamping portion 220 of the stapler 200. By configuring the medical device 100w in this manner, it is possible to simplify the configuration of the medical device 100w, and to make it easier to align the unfolded mesh member 10 along the end face of the cut site when the first clamping portion 210 and the second clamping portion 220 are opened from a reduced-sized state.
[0191] The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. The first to fourth embodiments and the modifications of each embodiment described above also include appropriate substitutions and combinations of each embodiment or modification. For example, in modification 12 of the first embodiment, the linear member of the fixing portion 30 according to the first embodiment is used in the configuration for reducing the dimensions of the mesh member 10 in the second clamping portion 220.
[0192] However, in addition to the above, in variant 12 of the first embodiment, any of the configurations of fixing portions 30q, 30r, 30s of the second embodiment or variants 1, 2, 3 of the second embodiment, etc. may be used as a configuration for reducing the dimensions of the mesh member 10 in the second clamping portion 220. [Explanation of symbols]
[0193] 1 health system, 10, 10a, 10b, 10c, 10d, 10e, 10f, 10p mesh-like members, 11 through holes, 12, 13 Part 1, 14, 15 second part, 16, 16d reinforcement part, 20 joints, 30 fixed part (linear member), 30b, 30c, 30p, 30t fixed part, 30q, 30r, 30s fixing part (mounting part), 30v fixed part (ring-shaped part), 100, 100a, 100b, 100c, 100p, 100q, 100s, 100t, 100v, 100w medical equipment, 200 stapler (medical device, linear stapler), 300 stapler (circular stapler).
Claims
1. a mesh-like member that is disposed between biological organs to be anastomosed, that is flat and has a plurality of through holes formed therein, and that includes a first portion and a second portion that are configured separately; a joining portion joined to the mesh member, The joint portion is configured to be formed in a strip shape to connect the first portion and the second portion in a separated state, The mesh member is a medical device having a substantially arc-shaped portion corresponding to an anastomosis portion of the living organ.
2. A medical device as described in claim 1, which can be used in conjunction with a medical device that is inserted into the body to form a cut site in the biological organ and suture the cut site, wherein only the joint is clamped by the medical device, and the first part and the second part are configured to cover the cut site.
3. The medical device according to claim 2 , further comprising a fixing portion for fixing the mesh member in a state in which the size in the planar direction of the mesh member is reduced.
4. The medical instrument according to claim 3 , wherein the mesh member can be temporarily integrated into the medical device in a state in which the dimensions are reduced by the fixing portion.
5. The medical device according to claim 1 , wherein the mesh-like member is applied to the anastomosis of the living organ to promote healing of the anastomosis.
6. The medical device according to claim 3 , wherein the mesh member includes a reinforcing portion that reinforces expansion of the mesh member in the planar direction from a state in which the size of the mesh member in the planar direction is reduced.
7. The medical device according to claim 3 , wherein the fixing portion comprises a long linear member that restricts the shape of at least a portion of the mesh member so that the dimension of the mesh member is reduced.
8. the linear member is cuttable, The medical device according to claim 7, wherein the mesh member can be expanded from the small size state by cutting the linear member.
9. the mesh member is sutured to the medical device by the linear member; The medical device according to claim 7, wherein the mesh member expands from the small size state by pushing out the linear members by the medical device.
10. the fixing portion includes an attachment member that is attachable to and detachable from the medical device and that restricts the shape of at least a portion of the mesh member so that the dimension of the mesh member is reduced; The medical device according to claim 3, wherein the mesh member has a reduced size when attached to the medical device by the attachment member, and can be expanded from the reduced size state by removing the attachment member from the medical device.
11. The medical device according to claim 3, wherein the fixing portion comprises a ring-shaped member that surrounds at least a portion of the mesh member so that the dimensions of the mesh member are reduced, and that slides from the point where it surrounds at least a portion of the mesh member to release the encirclement of the mesh member.
12. The medical device according to any one of claims 1 to 11; a medical device that is inserted into the body to form a cut site in the biological organ and suture the cut site.
Citation Information
Patent Citations
Apparatus for attaching supports to tissue staplers
JP1999508791A
annular adhesive structure
JP2008516678A
Surgical stapling apparatus including buttress attachment
JP2014094286A
Surgical Apparatus Including Surgical Buttress
US20120145767A1
Adjunct materials and methods of using same in surgical methods for tissue sealing
US20210177418A1