Anastomosis device

Abstract

A kit of parts is provided for forming a device for performing a first gastrointestinal anastomosis. The kit of parts includes an inner ring having an outer surface generally facing outwardly of the passageway, and an outer ring having an inner surface. When the inner and outer rings are in an assembled state, the inner ring is at least partially located within a receiving volume of the outer ring, at least a portion of the outer surface of the inner ring faces the inner surface of the outer ring, and the outer and inner surfaces define an annular space therebetween, at least a portion of which converges in a generally axial direction.

Description

[Technical Field]

[0001] Aspects and embodiments of the present invention relate to the field of devices for performing anastomosis, particularly for anastomosis of two gastrointestinal tract sections. [Background technology]

[0002] Anastomosis, the joining of two sections of a tubular organ in the gastrointestinal tract such as the esophagus, colon, or other parts, is often associated with complications such as leakage, infection, and fibrosis. For example, anastomotic leakage is observed in approximately 10% of cases of low anterior resection, including anastomosis of the colonic portion using conventional circular staples.

[0003] From the perspective of preventing complications after anastomosis, favorable results have been obtained by using compression anastomosis (see, for example, Kaider-Person et al., The American Journal of Surgery (2008) 195, 818-826). Conventional compression anastomosis involves clamping and fixing two tissue layers of the gastrointestinal tract between two members of a clamping device such as a known Murphy button, Boerema knot, Valtrac®, or magnetic ring (see, for example, Cossu et al., The American Surgeon (2000) (8), 759-762, and Jansen et al., Surgery, Gynecoloy & Obstetrics (1981) 153, 537-545).

[0004] Dutch Patent Application Publication No. 2017917 discloses a method for anastomosis between a first gastrointestinal tract section and a second gastrointestinal tract section, both including a surface layer and an intermediate layer, and a surgical instrument for the same purpose, typically a surgical stapler. The method includes bringing the surface layers of the gastrointestinal tract sections into contact with each other and compressing the contacted sections between a first pressurized area and a second pressurized area, during which the combined pressure of the first and second pressurized areas increases, pushing the surface layers laterally so that the intermediate layers come into contact.

[0005] U.S. Patent Application No. 20110264121(A1) discloses a sleeve-type fixation method for anastomosis of ring-shaped organs. At the anastomosis, two intestines are overlapped between an inner ring and an outer ring. The width of the anastomosis is approximately 4 to 5 millimeters, allowing contact between the serosal membranes of the intestines.

[0006] U.S. Patent No. 5,290,298 discloses a disassemblable compression device for anastomosis of hollow organs in the human body. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Despite favorable results, compression anastomosis still presents challenges. Therefore, the use of conventional surgical staples remains the common standard in anastomosis surgery. Conventional surgical staples do not compress the intestinal connection and maintain blood flow between staples. Thus, further improvements to compression anastomosis are desirable to simplify the procedure and make it more accessible. Improvements to compression anastomosis are also desirable from the perspective of the healing process, such as reducing postoperative complications. [Means for solving the problem]

[0008] The first embodiment provides a kit of components for forming a device for anastomosis of a first gastrointestinal tract section and a second gastrointestinal tract section. The component kit comprises an inner ring having an outer surface facing generally opposite to the fecal passage that passes through the inner ring generally in the axial direction, and an outer ring having an inner surface that has outer surface that has an inner surface that has an inner surface that has an outer surface that has an inner surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an inner surface that has an outer surface that has an outer surface that has an outer surface that has an outer surface that has an outer surface that

[0009] Generally, when we say that the inner and outer rings are assembled, it means that a portion of the first gastrointestinal tract section and a portion of the second gastrointestinal tract section are located between the inner and outer rings, particularly in the annular space.

[0010] When the first and second gastrointestinal tract sections are located between the inner and outer rings, at least one of the inner and outer rings is deformable. Thus, the shape of the annular space can differ depending on whether or not there are gastrointestinal tract sections between the inner and outer rings.

[0011] To be deformable, at least one of the inner ring and the outer ring may be made of a resilient, elastic material and / or a deformable material. Specifically, at least one of the outer surface of the inner ring and the inner surface of the outer ring may be deformable.

[0012] The tissues of the gastrointestinal tract are basically a tubular layered structure consisting of three different layers of tissue. The outer layer consists mainly of muscularis lamellae, the following submucosa consists mainly of collagen, and the luminal layer consists mainly of mucosa.

[0013] The annular space can be arranged to accommodate a part of both the first gastrointestinal tract cutting portion and the second gastrointestinal tract cutting portion. Specifically, the annular space can be sized to accommodate the submucosal layers of both the first gastrointestinal tract cutting portion and the second gastrointestinal tract cutting portion.

[0014] When in use, when the component kit is assembled by disposing the inner ring at least partially within the receiving volume of the outer ring, the first gastrointestinal tract cutting portion and the second gastrointestinal tract cutting portion can be compressed between the inner ring and the outer ring in the annular space. The inventors have found that when sufficient pressure is applied, the outer peripheral layer and the luminal layer become thinner, and in particular, the outer peripheral layer and the luminal layer are cut off, so that only the submucosal layer, or substantially only the submucosal layer, remains in at least a part of the annular space.

[0015] Compression of the gastrointestinal tract cutting portion can be achieved by the annular space between the inner ring and the outer ring being insufficient in size to accommodate the total thickness of the first gastrointestinal tract cutting portion and the second gastrointestinal tract cutting portion combined in an uncompressed state. In the assembled state, since at least a part of the annular space converges generally in the axial direction, different magnitudes of compression can be applied to the first gastrointestinal tract cutting portion and the second gastrointestinal tract cutting portion.

[0016] The amount of compression can be increased generally in the axial direction, particularly in the downstream direction of the gastrointestinal tract. Thus, when considered in the upstream direction, the amount of compression can reach zero or be substantially zero at a certain point. This applies to one or both of the gastrointestinal tract cutting portions and / or one or more layers of the gastrointestinal tract cutting portion such as the submucosal layer.

[0017] Most of the annular space, or at least a part of the thickness in the radial direction perpendicular to the axial direction, can be between 0.1 and 1.0 mm, particularly between 0.15 and 0.75 mm, and further between 0.3 and 0.5 mm.

[0018] The thickness of at least a portion, or most of the portion, of the annular space in the radial direction perpendicular to the axial direction may be 1.0 mm or less, 0.5 mm or less, or even 0.3 mm or less. When the radial thickness of the annular space is 1.0 mm or less, and especially 0.5 mm or less, the submucosa of the first and second gastrointestinal tract resections can be positioned in contact with each other. As a result, it is possible to favorably promote primary-intentional healing between the submucosa layers. Part of the annular space may have a width less than 1.0 mm, while other parts of the annular space may have a width greater than 1.0 mm, and it will be understood that the annular space converges from this larger width to a width less than 1.0 mm. The desired thickness of the annular space in the radial direction usually depends on the wall thickness of the gastrointestinal tract resection, especially the thickness of the submucosa.

[0019] Specifically, as the width of the annular space decreases to 1.0 mm or less, 0.5 mm or less, or even 0.3 mm or less, one or both of the serosa and mucosa layers at the gastrointestinal tract resection site—that is, the outer layer and the luminal layer, respectively—may detach or peel off from the submucosa as the inner ring moves into the receiving volume of the outer ring. Additionally or alternatively, the reduction in the thickness of the annular space may cause one or both of the serosa and mucosa layers to be crushed or decomposed, exposing the submucosa.

[0020] In its assembled state, the inner and outer rings are positioned to define an annular space between them, so that other parts of the annular space may have a thickness of more than 0.5 mm or more than 1.0 mm. During use, as the inner ring moves further into the outer ring and the width of the annular space narrows, the submucosal layers of the first and second gastrointestinal tract sections come into contact with each other.

[0021] It has been observed that contact between the submucosa of the first and second gastrointestinal resection sites improves healing between the first and second gastrointestinal resection sites and / or may improve the stability of the anastomosis of the patient's gastrointestinal resection compared to, for example, a state where only the serosal layers of both gastrointestinal resection sites are in contact. The submucosa has been observed to form the trunk of the gastrointestinal resection site, and therefore anastomosis between the submucosa of the gastrointestinal resection sites may be preferable as an alternative to or addition to anastomosis between serosal layers and / or between mucosal layers.

[0022] While not strictly necessary, it is preferable that the submucosa layers also come into contact with each other outside the outer ring, for example, axially outside the outer ring, or above or below the outer ring. Outside the outer ring may mean outside the receiving volume of the outer ring and / or outside the inner diameter of the outer ring.

[0023] It will be understood that when the inner and outer rings are moved to an assembled state in which the gastrointestinal tract section is positioned between the inner and outer rings, one or both of the inner and outer rings may be deformed elastically and / or plastically. Therefore, the desired shape and dimensions of the annular space may only be achieved, exemplarily, when the gastrointestinal tract section is positioned within the annular space. Thus, it will be understood that when the inner and outer rings are said to be in an assembled state in this disclosure, this may mean that the gastrointestinal tract section is positioned within the annular space.

[0024] Therefore, in the assembled state, the two gastrointestinal tract sections are positioned within an annular space, and the thickness of at least a portion of the annular space in the radial direction perpendicular to the axial direction is 0.5 mm or less, particularly 0.3 mm or less, and in this assembled state, the submucosal layers of the gastrointestinal tract sections can come into contact with each other.

[0025] As a further option applicable to any component kit disclosed herein, in the assembled state, the thickness of the annular space perpendicular to the centerline of the annular space may be 1.0 mm or less, particularly 0.5 mm or less, or even 0.3 mm or less for a portion of the annular space, and 1.0 mm or more, or even 0.5 mm or more for another portion of the annular space. These specific thicknesses compress the gastrointestinal tract sections together, allowing contact between the submucosa.

[0026] Thus, any part kit disclosed herein, in any combination of any inner ring and any outer ring, can be positioned in an assembled state with the portion of the gastrointestinal tract resection placed in the annular space such that the thickness of the annular space perpendicular to the centerline of the annular space is 1.0 mm or less, particularly 0.5 mm or less, 0.3 mm or less for some part of the annular space, and 0.5 mm or more, or even 1.0 mm or more, for other parts of the annular space, thereby allowing the submucosal layers of the gastrointestinal tract resection to be in contact with each other in the assembled state.

[0027] The direction of the fecal passage through the inner ring can generally be defined as axial, and feces typically move downstream through the gastrointestinal tract. The outer surface of the inner ring facing the opposite side of the fecal passage is thus at least partially oriented radially, where the radial direction is defined as being perpendicular to the axial direction.

[0028] Generally, the inner ring may be approximately symmetric, especially rotationally symmetric, with respect to its centerline, and the outer ring may be approximately rotationally symmetric, especially rotationally symmetric, with respect to its centerline. When in use, in the assembled state, the centerlines of the inner and outer rings may be aligned, or at least approximately aligned. The rings, such as the inner and / or outer rings, may have a generally circular or donut-shaped form, or may have any other arbitrary shape, such as generally oval or elliptical.

[0029] The outer surface of the inner ring and at least one of the inner surfaces of the outer ring can be provided by a rigid material composed of at least one of the inner ring and at least one of the outer ring.

[0030] Generally, the term "rigidity" is used to mean that, when an anastomosis device is in use, the materials composed of that device do not undergo any deformation that would affect the device's operation. Common synthetic materials include metals, composite materials, and thermosetting resins.

[0031] The opposite of a rigid material is an elastic material. The term elastic material means that, when an anastomosis device is used, the material composed of that device can deform when a force of the magnitude typically used with that device is applied. The material thus exhibits a certain stiffness, which is expressed in N / mm, i.e., the magnitude of the force in Newtons required for a particular deformation, expressed in millimeters. When the force is removed from the material, the material elastically deforms, at least partially, and returns to its original shape. Thus, in an elastically deformed state, an elastic material can exert force in the opposite direction to the applied force.

[0032] Optionally, the annular space between the outer surface of the inner ring and the inner surface of the outer ring may include, adjacent to the dispersed portion, a non-dispersive portion having a substantially constant cross-sectional area in a plane perpendicular to the axial direction.

[0033] The height of the annular space in the direction parallel to the axial direction may be between 4 and 20 mm, particularly between 4 and 6 mm, or at least greater than 2 mm, or at least greater than 4 mm. This height may allow sufficient portions of the first and second gastrointestinal tract sections to be compressed within the annular space.

[0034] Different types of connections may be used to connect the inner and outer rings. It is preferable to connect the inner and outer rings to each other and to the gastrointestinal tract during or after placement to prevent one or both rings from moving through the gastrointestinal tract, for example, due to peristalsis or the passage of fecal matter through the ring.

[0035] In general, the connection between the inner and outer rings may be a clamp connection using interference fitting between the two rings, a snap-fit ​​connection such as a cantilever snap-fit ​​consisting of one or more interlocking parts, a friction connection, any other connection, or any combination thereof. With respect to clamp connections, one or both of the inner and outer rings may be elastic.

[0036] Certain snap-fit ​​connections are feasible when a portion of the first inner and outer rings has a larger footprint than a portion of the second inner and outer rings. The footprint can be envisioned in a top view perpendicular to the centerlines of the inner and outer rings. When the inner ring is at least partially positioned within the receiving volume of the outer ring, the larger portion of the footprint can catch behind the smaller portion of the footprint. Rings with an ellipsoidal inner and / or outer shape can have a larger footprint than rings with a circular inner and / or outer shape.

[0037] A second aspect provides a method for anastomosis between a first gastrointestinal tract section and a second gastrointestinal tract section. This method includes the steps of: positioning an inner ring within the first gastrointestinal tract section to at least partially enclose the inner ring within the first gastrointestinal tract section; positioning an outer ring within the second gastrointestinal tract section to at least partially enclose the outer ring within the second gastrointestinal tract section; and moving the inner ring axially into the receiving volume of the outer ring. After the inner ring has moved sufficiently into the receiving volume of the outer ring, the inner ring is connected to or becomes connected to the outer ring.

[0038] As the inner ring is moved axially into the receiving volume of the outer ring, an annular space is formed between the outer surface of the inner ring and the inner surface of the outer ring. This annular space converges roughly axially, causing a portion of the first gastrointestinal tract section and a portion of the second gastrointestinal tract section to be compressed together within the annular space.

[0039] The compressed portions of the first and second gastrointestinal tract sections are oriented approximately axially. This is because at least a portion of the annular space can also be oriented approximately axially.

[0040] Specifically, after the inner ring moves into the receiving volume of the outer ring, a portion of the first gastrointestinal tract section and a portion of the second gastrointestinal tract section, mainly consisting of the submucosa, are present within the annular space. "Mainly present" means that a significant portion of the volume of the annular space filled with gastrointestinal tract, for example more than 50%, or even more than 80%, is filled with the submucosa.

[0041] The outer layer and luminal layer may be more compressible than the submucosa due to differences in material composition, for example. The material that makes up the submucosa has higher rigidity against compression, and the thickness of the submucosa may decrease less under compression than that of the outer layer and luminal layer.

[0042] When the two gastrointestinal tract sections are compressed between the inner and outer rings, it is preferable that the submucosa of the two gastrointestinal tract sections come into contact with each other. In general, contact between the submucosa can promote primary-intentional healing. Primary-intentional healing can improve the speed of the healing process and reduce the risk of leakage, infection, fibrosis, etc. Contact between the two submucosa can be achieved within or outside the annular space.

[0043] Alternatively, a fluid or other substance may be pushed or squeezed out of one or both of the outer and luminal layers, reducing the thickness and / or volume of these two layers under compression. Alternatively, one or both of the outer and luminal layers may detach or peel off from the submucosa, particularly when the inner ring moves into the receiving volume of the outer ring.

[0044] When the two gastrointestinal tract sections are compressed between the inner and outer rings, any debris, bacteria, or other material within the lumen of the gastrointestinal tract sections can be pushed out or moved in the direction of the centerline of the gastrointestinal tract sections, corresponding to the fecal passage through the inner ring. In this way, it is possible to prevent, at least partially, the debris, bacteria, or other material from coming into contact with the healing site where the two submucosal layers are in contact with each other.

[0045] As the inner ring moves into the receiving volume of the outer ring, the outer ends of the first and second intestinal resections may be severed. The severed portions can be expelled from the body through the anus. Severing of the gastrointestinal resection can be performed using two interacting portions of the inner and outer rings. One or both of the interacting portions may have one or more sharp or serrated ends or surfaces and be pressed against, for example, the other interacting portion. The portion of the gastrointestinal resection located between the two interacting portions may thus be completely or partially severed, or at least perforated.

[0046] In embodiments of this method, an anvil with a cutting edge can also be used to cut the gastrointestinal tract section. The anvil is a separate element from the inner ring and the outer ring. When in use, the anvil can be positioned inside the inner ring. When the inner ring with the anvil is positioned inside the first gastrointestinal tract section, the anvil can be used to pull the inner ring into the receiving volume of the outer ring. If the inner ring does not move any further into the receiving volume of the outer ring, the anvil can be detached from the inner ring and pulled through the ring, thereby cutting the portions of the first and second gastrointestinal tract sections that surround the inner and outer rings, respectively.

[0047] Optionally, the parts kit may include an auxiliary retaining ring, which is positioned to cooperate with the anvil in cutting the gastrointestinal tract section. When in use, the auxiliary retaining ring can be positioned downstream of the outer ring in the second gastrointestinal tract section. The auxiliary retaining ring may have a sharp and / or serrated surface and / or ends. After the anvil has passed the inner ring, the anvil can come into contact with the sharp or serrated portion of the auxiliary retaining ring to cut the gastrointestinal tract section.

[0048] In this embodiment of the method, after the inner ring moves into the receiving volume of the outer ring, the submucosa of the two gastrointestinal tract sections is positioned in contact with each other, particularly around the entire circumference. Due to the shape of the annular space, the contact portion of the submucosa is essentially separable from bacteria originating from the mucosa and feces. Providing the muscular layers of the two gastrointestinal tract sections close to the outside of the annular space may be preferable, as this may thereby promote healing by primary intent.

[0049] A third aspect provides a placement device for arranging a device comprising an inner ring and an outer ring for anastomosis of a first gastrointestinal tract section and a second gastrointestinal tract section.

[0050] It will be understood that the method according to the second embodiment can be implemented by using the components of the parts kit according to the first embodiment and / or by using the placement device according to the third embodiment. Thus, any optional features disclosed in connection with one embodiment can be readily applied to embodiments of the other two embodiments. [Brief explanation of the drawing]

[0051] [Figure 1A] This is a top view adjacent to the perspective view of the first embodiment of the parts kit. [Figure 1B] This is a cross-sectional view shown by AA in the top view of Figure 1A. [Figure 2] Figures 1A and 1B are schematic diagrams of the unassembled parts kit. [Figure 3A]This diagram shows different steps in the method for anastomosis between the first and second gastrointestinal tract sections. [Figure 3B] This diagram shows different steps in the method for anastomosis between the first and second gastrointestinal tract sections. [Figure 3C] This diagram shows different steps in the method for anastomosis between the first and second gastrointestinal tract sections. [Figure 4A] This figure shows a second embodiment of a parts kit for forming an anastomosis device. [Figure 4B] This figure shows a second embodiment of a parts kit for forming an anastomosis device. [Figure 4C] This figure shows a second embodiment of a parts kit for forming an anastomosis device. [Figure 5A] This is a perspective view of a setup device for arranging equipment to perform anastomosis of two gastrointestinal tract sections. [Figure 5B] This is a perspective view of a setup device for arranging equipment to perform anastomosis of two gastrointestinal tract sections. [Figure 6A] This figure shows one embodiment of the placement device. [Figure 6B] This figure shows different cross-sections of the placement device. [Figure 7A] This figure shows different cross-sections of the placement device. [Figure 7B] This figure shows different cross-sections of the placement device. [Figure 7C] This figure shows different cross-sections of the placement device. [Figure 7D] This figure shows different cross-sections of the placement device. [Figure 8] This is a detailed view of Figure 3C. [Figure 9] This is a color photograph of an experiment in which two gastrointestinal tract sections were compressed and inserted into the annular space between the outer and inner rings. [Figure 10] This is a monochrome version of the photograph in Figure 9. [Modes for carrying out the invention]

[0052] Figure 1A shows a top view adjacent to a perspective view of the assembled state of a component kit for forming a device that anastomoses a first gastrointestinal tract section and a second gastrointestinal tract section. Figure 1B is a cross-sectional view shown as AA in the top view of Figure 1A.

[0053] The parts kit includes an embodiment of an inner ring 100 that defines a passage 102 through which feces pass. The inner ring 100 generally includes an outer surface 101 facing away from the passage 102.

[0054] The embodiment of the component kit shown in Figures 1A and 1B further includes an outer ring 200 that defines a receiving volume 202 that receives at least a portion of the inner ring. The outer ring 200 includes an inner surface 201 that at least partially faces the direction of the receiving volume 202.

[0055] For example, as shown in Figure 1B, in the assembled state, the inner surface 201 of the outer ring 200 faces the direction of the inner ring 100. The outer surface 101 of the inner ring 100 faces the direction of the outer ring 200. Specifically, the outer surface 101 faces the inner surface 201 at least partially.

[0056] The outer ring 200 and the inner ring 100 are optionally arranged coaxially with respect to the center line 105 and substantially rotationally symmetrical with respect to the center line 105. In Figures 1A and 1B, the axial direction can be defined as parallel to the center line 105.

[0057] In the assembled state, as shown in Figure 1B, for example, an annular space 300 is formed between the outer ring 200 and the inner ring 100, specifically between the outer surface 101 and the inner surface 201.

[0058] As shown in Figure 1B, the outer ring 200 may optionally include an inner flange 203 that is oriented toward the passage 102 for feces, or in some cases protrudes into the passage. Specifically, the inner flange 203 may have an inner diameter smaller than one or more portions of the inner surface 201 of the outer ring 200 adjacent to the inner flange 203.

[0059] The inner diameter of the inner flange 203 corresponds to a portion of the outer diameter of the outer surface 101 of the inner ring 100. Correspondence here can mean one of the following: a rubbing fit, a light rubbing fit, or a loose fit between the inner flange 203 and the inner ring 100. One or both of the surfaces of the inner flange 203 that contact adjacent portions of the inner surface 201 of the outer ring can be rounded, chamfered, or at least partially oriented obliquely to the radial direction.

[0060] In Figures 1A and 1B, the inner flange 203 is depicted as being composed of the outer ring 200, but the inner ring 100 may have an outer flange in addition to or as an alternative to the inner flange 203.

[0061] When interfering fitting or other types of fitting occur between the inner ring 100 and the outer ring 200, in any embodiment of the parts kit, the inner flange 203 makes it possible to reduce and even prevent leakage of feces between the inner ring 100 and the outer ring 200.

[0062] As shown in Figure 1B, and as an option applicable to any embodiment of the component kit, a portion 300' of the annular space 300 has a substantially constant cross-section. The radial thickness of this portion 300' may correspond to the thickness of two compressed submucosal layers.

[0063] Figure 2 is a schematic diagram of the unassembled parts kit shown in Figures 1A and 1B. The inner ring 100 is positioned within a first gastrointestinal resection 301, which may be a proximal gastrointestinal resection. The outer ring 200 is positioned within a second gastrointestinal resection 302, which may be a distal gastrointestinal resection. The gastrointestinal resections can be partially closed, for example, using a purse-string suture, to partially close each gastrointestinal resection.

[0064] Figures 3A, 3B, and 3C illustrate different stages of the method for anastomosing the first gastrointestinal tract section 301 and the second gastrointestinal tract section 302. As schematically shown in Figures 3A, 3B, and 3C, the gastrointestinal tract section generally includes an outer layer 311 made of muscular layer, a luminal layer 313 made of mucosa, and a submucosal layer 312 between the outer layer 311 and the luminal layer 313.

[0065] In the first step of the method shown in Figure 3A, an embodiment of the inner ring 100 is positioned within the first gastrointestinal tract section 301, and an embodiment of the outer ring 200 is positioned within the second gastrointestinal tract section 302. As can be seen from Figure 2, the gastrointestinal tract section surrounds the inner ring and the outer ring, at least partially, respectively. Therefore, for example, when the inner ring 100 is moved axially, the first gastrointestinal tract section 301 also moves axially with the inner ring. The inner ring and the outer ring can be configured such that one slides or fits into the other.

[0066] In the second step of the method shown in Figures 3B and 3C, the inner ring 100 moves axially to enter at least partially into the receiving volume 202 of the outer ring 200. During this movement, an annular space 300 is formed between the outer surface 101 and the inner surface 201 of the inner ring 100. Parts of the first gastrointestinal tract section 301 and part of the second gastrointestinal tract section 302 are press-fitted into the annular space 300. This annular space 300 can therefore have a radial thickness smaller than the thickness of the two gastrointestinal tract sections.

[0067] Figure 3C shows the third step of the method, in which a portion of the first gastrointestinal tract section and a portion of the second gastrointestinal tract section are compressed together in an annular space. Furthermore, another portion 301' of the first gastrointestinal tract section and another portion 302' of the second gastrointestinal tract section are cut off, for example, while the inner ring 100 moves into the outer ring 200. The cut-off portions of the first gastrointestinal tract section 301' and the second gastrointestinal tract section 302' may be surrounded by the inner ring 100 and the outer ring 200, respectively, before the inner ring 100 moves axially and enters the receiving volume 202 of the outer ring 200.

[0068] Parts of the gastrointestinal tract section 301' and gastrointestinal tract section 302' can be cut off by fitting between the inner flange 203 of the outer ring 200 and the inner ring 100, or by another cutting section formed by one or both of the inner and outer rings.

[0069] As schematically shown in Figure 3C, the submucosal layer 312 is primarily located within the annular space 300, for example, due to a specific radial thickness of the annular space 300. Within the annular space 300, the outer layer 311 and / or luminal layer 313 may be even more compressed than the submucosal layer 312.

[0070] Because the annular space has a divergent, tapered, and / or funnel-shaped form, different degrees of compression can usually be achieved in different parts of the gastrointestinal tract. For example, in or near the widest part of the annular space, the gastrointestinal tract may be compressed little or not at all, while compression increases in the narrower parts of the annular space. In or near the part of the annular space where the gastrointestinal tract is compressed little or not at all, it is possible for uncompressed submucosa to be in close proximity. Further along the narrower part of the annular space, it is possible to gradually compress two submucosa layers.

[0071] Figures 4A, 4B, and 4C show a second embodiment of a component kit for forming an anastomosis device, representing a top view, a perspective view, and a cross-sectional view along plane AA of Figure 3A, respectively.

[0072] A second embodiment of the parts kit consists of an inner ring 100 and an outer ring 200, the inner ring 100 defining a fecal passage 102 and the outer ring defining a receiving volume 202 that receives at least a portion of the outer ring 200.

[0073] The component kits in Figures 4A, 4B, and 4C are shown in their assembled state. Thus, the annular space 300 is defined between the outer surface 101 of the inner ring 100 and the inner surface 201 of the outer ring 200. A portion of the annular space 300 converges in a generally axial direction parallel to the center line 105, particularly in the downstream axial direction. In other words, the annular space 300 diverges in the upstream direction of the axis.

[0074] As a specific option, for example as shown in Figure 4C, the outer ring includes an inward-facing shoulder 204 as an example of an inner flange. The inner ring 100 includes an outward-facing shoulder 104. In the assembled state, the inward-facing shoulder 204 is oriented at a certain angle with respect to the centerline 105, for example, on a plane substantially perpendicular to the centerline 105, i.e., radially, so as to abut the outward-facing shoulder 104.

[0075] As a further option, for example as shown in Figure 4C, the inward-facing shoulder portion 204 of the outer ring 200 is provided with one or more sawtooth teeth 206 protruding from the surface 208 of the inward-facing shoulder portion 204, and this surface 208 faces at least partially axially, i.e., parallel to the centerline 105. These sawtooth teeth 206 can cut or at least perforate the gastrointestinal tract section.

[0076] Figures 5A and 5B are two perspective views of a placement device for arranging equipment to perform anastomosis of two gastrointestinal tract sections.

[0077] The placement device 400 includes a housing 402, which may be flexible in the sense that the shape of the housing 402 can be manipulated by the surgeon at least partially. For example, the housing 402 consists of a plurality of parts that are hinged or rotatably connected, and the plurality of parts can hinge or rotate relative to each other.

[0078] The placement device 400 includes a translatable element 404 at the distal end 401 of the housing 402, which is connected to the inner ring of the anastomosis device, and this translatable element is positioned to translate along a translation axis 406. A connecting element 414 for connecting to the inner ring may be provided at the distal end of the translatable element 404. The connecting element 414 may be thicker than the translatable element 404; that is, the connecting element 414 may have a larger outer diameter than the translatable element 404.

[0079] At the proximal end 403 of the housing, the placement device 400 includes an actuator 408 that rotates around a rotation axis 410. This rotation axis is positioned obliquely to the translation axis 406. Specifically, the rotation axis can be positioned perpendicular to the translation axis 406. For example, if a portion of the housing 402 is flexible, the translation axis 406 and the rotation axis 410 do not necessarily intersect.

[0080] The arrangement device further includes a coupling device that, for example, uses a rack and pinion mechanism, a threaded spindle, a cycloidal drive, or any other threaded mechanism to connect the actuator 410 to the translatable element 404, thereby converting the rotation of the actuator into translation of the translatable element. The coupling device may be located within or covered by the housing 402 and is therefore not visible in Figures 5A and 5B. The actuator should be understood as a component arranged to receive force and / or torque input, for example, from a surgeon. The actuator may also be referred to as the actuated element.

[0081] The transmission device can consist of, for example, a coupling device including one or more gears, racks, or other arbitrary rotational transmission elements. The transmission device can be used to convert the rotational speed of the actuator to a lower speed of the translational element. As a result, it is possible to reduce the torque required to rotate the actuator. For example, the transmission device may have a gear ratio of 32:1 or greater, 16:1 or greater, or 2:1 or greater.

[0082] Optionally, the placement device 400 may further include a handle 412, which can be positioned opposite the actuator 408. Thus, the rotating shaft 410 can extend through a portion of the handle 412. The handle 412 is connected to the housing at its proximal end 403.

[0083] At least a portion of the handle 412 is shaped like an ellipsoid, particularly a triaxial ellipsoid, and may be more than half of the ellipsoid. In this way, the handle 412 can be conveniently held regardless of hand size.

[0084] When the device is in use, the distal end 401 of the placement device 400 can be inserted into the patient, for example, through the patient's anus. When in use, the proximal end 403 of the placement device 400 can be placed outside the patient's body so that, for example, the actuator 408 can be operated by a surgeon.

[0085] Figure 6A is a perspective view showing one embodiment of an end effector 416 of a placement device, such as the one shown in Figure 5A. The end effector 416 comprises a translationable element 404 and a connecting element 414 for connecting to an inner ring.

[0086] Figure 6B schematically shows a cross-sectional view of the end effector 416 of Figure 6A, in which the inner ring 100 is connected to the connecting element 414 and the outer ring 200 is connected to the end effector body 418. As can be seen from Figure 6B, by moving the translationable element 404 and the connecting element 414 together with it, the inner ring 100 can move toward and into the outer ring 200.

[0087] The placement device optionally includes a cutting ring 420, which may have a sharp cutting edge or a serrated end, for example, as shown in Figure 6A. The serrated end allows for the cutting of the gastrointestinal portion. The outer ring 200 can be fixed to the cutting ring 420 and thus fixed to the end effector 416 of the placement device.

[0088] Figures 7A to 7D schematically illustrate the arrangement of the inner ring 100 and outer ring 200 for anastomosis in four steps. The gastrointestinal tract is not shown in the figures for clarity.

[0089] In the first step shown in Figure 7A, the inner ring 100 is partially positioned within the outer ring 200 and in contact with the cutting ring 420. In the second step, the translationable element 404 is further pulled down to the state shown in Figure 7B. As can be seen in Figure 7B, the cutting ring 420 has finished moving relative to the end effector body 418 which has an optional receiving volume 422 that allows the movement of the cutting ring 420. Prior to the first step, for example as shown in Figure 3A, the inner ring is positioned within the first gastrointestinal tract section and the outer ring is positioned within the second gastrointestinal tract section.

[0090] In the state shown in Figure 7B, the annular space between the outer surface of the inner ring and the inner surface of the outer ring is completely formed.

[0091] Figure 7C shows a third step in which the translationable element 404 is further pulled down. As a specific option, the connecting element 414 to which the inner ring 100 is connected is equipped with a flexible crown 422. In the first and second steps, the flexible crown 422 allows the inner ring 100 to be pulled into the outer ring 200. The magnitude of the force required to pull down the inner ring 100 increases as the inner ring 100 is pulled into the outer ring 200, causing the flexible crown 422 to bend inward, thereby sliding through the inner ring 100.

[0092] The flexible crown 422 may consist of a plurality of hinge fingers, for example, as shown in Figures 7A to 7D, or it may be made of any elastic or flexible material that generally allows deformation of the flexible crown 422. The deformation may be elastic deformation and / or plastic deformation. For example, one or more fingers may break to allow the connecting element 414 to penetrate the inner ring 100.

[0093] Between the states shown in Figures 7B and 7C, as the inner ring connecting element 414 passes through the inner ring 100, the cutting edge 424 of the connecting element 414 interacts with the cutting ring 420, cutting a portion of the gastrointestinal tract. The connecting element 414 can thus act as a cutting anvil.

[0094] Figure 7D shows the fourth step, after the end effector 416 has been withdrawn from the inner and outer rings. This allows the end effector 416 to be removed from the patient's body, leaving the inner and outer rings inside the body with the two gastrointestinal tract sections compressed between them.

[0095] Figure 8 is a detailed diagram of the third step of the method, in which a portion of the first gastrointestinal tract section 301 and a portion of the second gastrointestinal tract section 302 are compressed together in the annular space 300 between the inner ring 100 and the outer ring 200. Figure 8 is a partial detail view of Figure 3C.

[0096] As shown in Figure 8 and other figures, and as an option readily applicable to any embodiment of the inner ring 100 disclosed herein, the inner ring 100 may have an outwardly projecting shoulder 180. A portion of the outer surface 101 of the inner ring 100 is formed by the shoulder 180, and this portion is capable of contacting the luminal layer 383 of the first gastrointestinal tract section 301 during use. Generally, any shoulder disclosed herein may be alternatively referred to as a flange or radial extension.

[0097] In the example shown in Figure 8, the shoulder portion 180 does not extend radially beyond the inner diameter of the outer ring 200, but in other examples of the inner ring 100, the shoulder portion 180 may extend further radially. For example, the shoulder portion 180 projecting outward from the inner ring 100 can project beyond the inner surface of the outer ring 200 (see Figure 1B). In other examples, the shoulder portion 180 projecting outward from the inner ring 100 may project beyond at least a portion of the outer surface of the outer ring 200, or even beyond the outer diameter of the outer ring 200.

[0098] The inventors have found that specific dimensions of the inner ring 100 and the outer ring 200 can be beneficial for the healing process between the gastrointestinal tract cut portions, and / or the stability of the inner and outer rings in the gastrointestinal tract, and / or the strength of the anastomosis. Specifically, the dimensions of the inner ring 100 and the outer ring 200 are preferably selected such that the submucosa 312 and the submucosa 382 of the gastrointestinal tract cut portions can come into contact during use. The contact surface area between the submucosa 312 and the submucosa 382 can be formed or enlarged by some dimensions of the inner and outer rings.

[0099] Preferably, the width W

[0101] , min , min , min , min , , p , , p , p , p ,

[0100] , , also called the minimum thickness, is 0.5 mm or less, particularly 0.3 mm or less. This minimum thickness is preferably achieved over a specific height represented by H in FIG. 8. This height H p is preferably between 1.0 and 5.0 mm, particularly between 1.0 and 2.0 mm. Over the height H p the width of the annular space 300 can be substantially constant. In a further portion of the annular space, for example, by the inner flange 203 of the outer ring 200, a width smaller than the width W p may exist. It has been observed that a height H between 1.0 and 5.0 mm min prevents the gastrointestinal tract cut portion from slipping out of the annular space between the inner and outer rings. p prevents the gastrointestinal tract cut portion from slipping out of the annular space between the inner and outer rings.

[0100] In the example of FIG. 8, the width W min is achieved over a portion parallel to the axial direction of the annular space 300. However, it will also be understood that embodiments of the inner and outer rings are envisioned where the portion of the annular space 300 where the width W min is achieved is oriented obliquely with respect to the axial direction. In such a case, the minimum width or minimum thickness W min can be considered to be in a direction perpendicular to both when perpendicular to the inner surface of the inner ring, perpendicular to the inner surface of the outer ring, or when its outer surface and its inner surface are oriented parallel. <000039The axial height of the outer ring 200 contributing to the annular space 300 is H in Figures 4C and 8. o It is written as follows. When assembled, a part of the inner ring 100, such as a shoulder portion 180 that protrudes outward, extends axially beyond the outer ring 200, H o +H s An annular space 300 having a total height H can be further defined by the inner ring 100. Preferably, in any combination thereof, the height H o The height is between 2.0 and 6.0 mm, especially between 2.0 and 3.0 mm. s The range is between 1.5 and 2.5 mm, particularly between 1.75 and 2.25 mm.

[0102] The annular space 300, which generally converges in the axial direction, particularly downward, is assumed to have a thickness T in the normal, i.e., vertical direction, to at least one gastrointestinal tract section. c The wall thickness of the combination of the two gastrointestinal tract sections, called the tectonic ring, gradually decreases as the tubular portion is compressed within the annular space 300 as the inner ring moves into the outer ring. In particular, thickness T c However, the minimum width W is calculated from the sum of the wall thicknesses t of the two gastrointestinal tract sections in their most uncompressed state. min or reduced to, for example, the section of the gastrointestinal tract that is cut—see, for example, sections 301' and 302' in Figure 3C. The total wall thickness of the gastrointestinal tract section in an uncompressed state is generally T max It is called T max It is roughly equal to twice t. It should be understood that the wall thickness of the gastrointestinal tract—shown as thickness t in Figure 8—can vary from person to person.

[0103] For example, the wall thickness of the gastrointestinal tract is usually about 2.25 mm, or 2.0-2.5 mm, in the adult colon. Depending on a person's age and physical condition, the wall thickness of the gastrointestinal tract can range from 1.5 to 3.0 mm. However, it should be understood that the wall thickness of the gastrointestinal tract may exceed 3.0 mm depending on the medical condition and / or certain treatments such as radiation therapy. Therefore, the component kit will have a thickness T perpendicular to the centerline of the annular space, depending on the wall thickness of the gastrointestinal tract section to be anastomosed. aIt is possible to form an annular space with dimensions of 1.5 mm or less, 1.0 mm or less, 0.5 mm or less, and especially between 1.5 mm and 0.05 mm, using inner and outer rings of specific sizes.

[0104] Those skilled in the art will understand that the gastrointestinal tract section may generally have overlapping projections and / or fragments. Therefore, the wall thickness as defined herein can be applied, for example, to a gastrointestinal tract section stretched by an inner or outer ring inserted into the section. Typically, the outer diameter of the outer ring may be in the range of 20 mm to 40 mm, particularly 25 mm to 35 mm.

[0105] The aspects and embodiments of this disclosure, without limitation, will be understood to be applicable to the anastomosis of any type of gastrointestinal tract section, such as the esophagus, intestine, small intestine, large intestine, and any other gastrointestinal tract section.

[0106] T max and W min It has been observed that there is an optimal or at least advantageous spot or range—also known as the sweet spot or sweet range—between these points. Within this spot or range, primary-intentional healing is known to occur between the submucosal layers of the gastrointestinal tract resection site. Specifically, W min <T c <T max The optimal or at least favorable thickness T is perpendicular to at least one gastrointestinal tract section. c The thickness is between 0.2 mm and 3.5 mm. Therefore, it is preferable that at least a portion of the annular space is such that, in the assembled state in which the two gastrointestinal tract sections are arranged in the annular space, the gastrointestinal tract sections are compressed to a thickness of 0.2 mm to 3.5 mm, particularly between 0.5 mm and 2.5 mm.

[0107] As shown in Figure 8, at least a portion of the contact area between the submucosa 312 and the submucosa 382 may be located outside the annular space 300. Additionally or alternatively, at least a portion of the contact area between the submucosa 312 and the submucosa 382 may be located above the outer ring when considered in the axial direction. This contact area is generally indicated by arrow A in Figure 8.

[0108] A centerline can be defined for any annular space in any part kit comprising an inner and outer ring as disclosed herein. For example, in Figures 1B, 4C, and 10, the centerline is shown by the dashed line c. From any point on this centerline, the distance perpendicular to the centerline toward the inner surface of the outer ring is equal to the distance toward the outer surface of the inner ring. The sum of these two distances is the thickness T of the annular space 300. a It is called [this]. Thickness T a Examples are shown in Figures 1B, 4C, 9, and 10. The thickness T is when the two gastrointestinal tract sections are placed in an annular space and assembled with the inner ring and the outer ring. a is, thickness T c This corresponds to the combined thickness of the compressed gastrointestinal tract sections.

[0109] When the two gastrointestinal tract sections are within the annular space 300 during use, the contact area A between the two gastrointestinal tract sections is approximately aligned with the center line, especially if the rigidity of the gastrointestinal tract sections is equivalent. In actual examples, the deviation between the contact area A and the center line in at least a portion of the annular space 300 between the two gastrointestinal tract sections may be, for example, ±10% or ±20% or more.

[0110] In any embodiment of a parts kit including any combination of any inner ring and any outer ring disclosed herein, the thickness T of at least a portion of the annular space 300 perpendicular to the center line c a The thickness T may be in the range of 0.0 mm to 10.0 mm, or 0.0 mm to 5.0 mm. Preferably, a - Defined perpendicular to the center line c - At least a portion of the center line c.

[0111] In an assembled state where the gastrointestinal tract section is in an annular space, if at least one of the outer ring and the inner ring deforms, the shape of the center line c and the thickness T at different positions along the center line c are affected. a It will be understood that this can be affected by the presence of a section of the gastrointestinal tract within the annular space.

[0112] For example, as can be seen in Figure 8, a portion of the second gastrointestinal tract section 302 is bent radially inward and protrudes into the annular space. The portion of the second gastrointestinal tract section 302 within the annular space can be considered inverted relative to the rest of the second gastrointestinal tract section 302. Specifically, a portion of the second gastrointestinal tract section 302 is bent on the outer ring 200, and on the curved upper portion 280 of the outer ring 200. The curvature of this upper portion 280 can be designed to achieve a desired shape for the converging portion of the annular space 300.

[0113] Figure 9 shows a photograph of an experiment in which two gastrointestinal tract sections 301 and 302 are compressed within an annular space 300 formed by moving the inner ring 100 into the outer ring 200. Figure 10 shows the same photograph, but in black and white, whereas Figure 9 is a color photograph. Figures 9 and 10 clearly show the different layers composed of the gastrointestinal tract sections 301 and 302—namely, the outer layers 311 and 381, the submucosal layers 312 and 382, ​​and the luminal mucosal layers 313 and 383.

[0114] In Figure 9, the shapes of the inner and outer rings can be identified using the shapes of the deformed gastrointestinal tract sections 301 and 302. To further clarify the shapes of the inner ring 100 and the outer ring 200, the ring outlines are schematically shown by dashed lines in Figure 10. The inner and outer rings shown in the assembled state in Figures 9 and 10 form an annular space, which has a thickness T perpendicular to the center line c, with a thickness of 1.0 mm or less in one part of the annular space and 1.0 mm or more in another part of the annular space. a It holds.

[0115] As shown in Figure 9, at a specific point c' on the centerline c of the annular space 300, the outer layers 311 and 381 are compressed and disappear, exposing the submucosa, and thus the submucosa layers 312 and 382 come into contact. This specific point c' on the centerline is related to the thickness T a It has a diameter of ' and may be in the range of 0.5 mm to 3.5 mm, particularly between 1.0 mm and 2.5 mm.

[0116] Figures 9 and 10 also show that, due to the size and shape of the annular space, the luminal layers 313 and 383 are peeled away from or torn from the submucosa, or at least crushed or compressed. Thus, in at least a portion of the annular space, particularly in at least a portion of the convergence of the annular space, essentially only the submucosa is present, or at least the majority of that portion of the annular space is occupied by the submucosa.

[0117] In the above explanation, it will be understood that when an element is connected to another element, it means that the element is either directly connected to the other element, or that there may also be an intervening element. Furthermore, it will be understood that the values ​​given in the above explanation are merely examples, and other values ​​may be possible and / or may be the target values.

[0118] Please note that the figures are merely schematic representations of embodiments given as non-limiting examples. For the sake of clarity and brevity, features have been described herein as part of the same or separate embodiments, but it will be understood that the scope of this disclosure may include embodiments having all or some combinations of the described features.

[0119] The term "prepare" does not preclude the existence of other features or steps. Furthermore, "one" should not be considered limited to "just one," but rather used to mean "at least one," and does not exclude multiple.

Claims

1. A component kit comprising a device for anastomosis of a first gastrointestinal tract section and a second gastrointestinal tract section, wherein the component kit comprises: An inner ring having an outer surface facing approximately opposite the passage, which defines a fecal passage that penetrates the inner ring generally in the axial direction, An outer ring comprising an outer ring having defined receiving volume for at least partially receiving the inner ring inside, and an inner surface that at least partially faces the direction of the receiving volume, Equipped with, In an assembled state in which the inner ring and the outer ring are positioned at least partially within the receiving volume of the outer ring, at least a portion of the outer surface of the inner ring faces the inner surface of the outer ring, and the outer surface and the inner surface define an annular space between them. A parts kit in which at least a portion of the aforementioned annular space converges generally in the axial direction.

2. In the assembled state, the thickness (W) of at least a portion of the annular space in the radial direction perpendicular to the axial direction. ｍｉｎ The component kit according to claim 1, wherein the diameter is 1.0 mm or less, particularly 0.5 mm or less, and moreover 0.3 mm or less.

3. In the assembled state in which a portion of the two gastrointestinal tract sections is positioned within the annular space, the thickness (W) of at least a portion of the annular space in the radial direction perpendicular to the axial direction ｍｉｎ The component kit according to claim 1, wherein the diameter is 1 mm or less, particularly 0.5 mm or less, and even more precisely 0.3 mm or less, and in the assembled state, the submucosal layers of the gastrointestinal tract section can come into contact with each other.

4. In the assembled state, the thickness of the annular space (T) perpendicular to the center line (c) of the annular space. ａ The component kit according to claim 1, wherein the length of the component is 0.5 mm or less or 0.3 mm or less with respect to a part of the annular space, and 1.0 mm or more with respect to another part of the annular space.

5. In the assembled state in which the two gastrointestinal tract sections are arranged within the annular space, the thickness of the annular space (T) is perpendicular to the center line (c) of the annular space. ａ The component kit according to claim 1, wherein the diameter of the component is 1.0 mm or less with respect to a part of the annular space, more specifically 0.5 mm or less or 0.3 mm or less, and is 1.0 mm or more with respect to another part of the annular space, so that the submucosal layers of the gastrointestinal tract section can come into contact with each other in the assembled state.

6. The component kit according to claim 1, wherein at least one of the outer surface and the inner surface is provided by a rigid material composed of at least one of the inner ring and the outer ring.

7. The component kit according to claim 1, wherein the annular space between the outer surface of the inner ring and the inner surface of the outer ring consists of a non-dispersive portion having a substantially constant cross-sectional area in a plane perpendicular to the axial direction.

8. The component kit according to claim 1, wherein the height of the annular space in the direction parallel to the axial direction is between 2 and 20 mm, particularly between 4 and 6 mm.

9. The component kit according to claim 1, wherein the outer ring is provided with an inner flange that protrudes toward the fecal passage.

10. The component kit according to claim 9, wherein the inner diameter of the inner flange corresponds to the outer diameter of the outer surface portion of the inner ring.

11. The parts kit according to claim 1, wherein the outer ring has an inward-facing shoulder portion, the inner ring has an outward-facing shoulder portion, and in the assembled state, the inward-facing shoulder portion is arranged to abut against the outward-facing shoulder portion.

12. The component kit according to claim 11, wherein the inward-facing shoulder portion of the outer ring is provided with one or more sawtooths protruding from the surface of the inward-facing shoulder portion, and the surface is at least partially oriented in the axial direction.

13. The component kit according to claim 1, wherein the inner ring has shoulders that protrude outward.

14. The parts kit according to claim 13, wherein in the assembled state, at least a portion of the outwardly protruding shoulder portion extends axially beyond the inner ring.

15. The component kit according to claim 1, wherein the outer ring has a lower height than the inner ring when the inner ring is aligned with the end of the outer ring.

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