Anastomosis Devices

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 anastomosis, and in particular to devices for performing anastomosis of two gastrointestinal sections. [Background technology]

[0002] Anastomosis, i.e. the joining of two sections of a tubular organ of the gastrointestinal tract, such as the esophagus, colon or other segments, is often associated with complications such as leakage, infection, fibrosis, etc. For example, anastomotic leakage is observed in approximately 10% of cases of low anterior resection involving anastomosis of colonic segments with a conventional circular stapler.

[0003] In terms of preventing post-anastomotic complications, 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, for example, clamping two tissue layers of the gastrointestinal tract between two members of a clamping device such as a well-known Murphy button, Boerema knot, Valtrac® or magnetic ring (see, respectively, Cossu et al., The American Surgeon (2000) (8), 759-762 and Jansen et al., Surgery, Gynecology & Obstetrics (1981) 153, 537-545).

[0004] NL 2017917 A1 discloses a method and a surgical instrument therefor, typically a surgical stapler, for performing an anastomosis of a first gastrointestinal section and a second gastrointestinal section, each of which includes a surface layer and a middle layer. The method comprises contacting the surface layers of the gastrointestinal sections and compressing the contacted sections between a first pressure zone and a second pressure zone, during which the sum of the first pressure zone and the second pressure zone increases, so that the surface layer is forced laterally and the middle layer is brought into contact.

[0005] US Patent Application No. 20110264121(A1) discloses a sleeve-type fixation method for anastomosis of circular organs. At the anastomosis, two intestines are overlapped between an inner ring and an outer ring. The width of the anastomosis is about 4-5 mm, allowing contact between the serosa of the intestines.

[0006] US Pat. No. 5,290,298 discloses a disintegrable compression device for hollow viscera anastomosis in the human body. Summary of the Invention [Problem to be solved by the invention]

[0007] Despite the positive results, compression anastomosis continues to present challenges. For this reason, the use of conventional surgical staplers is the general standard in anastomosis surgery. Conventional surgical staplers do not provide compression to the intestinal connections and preserve blood flow between the staples. Therefore, further refinements to compression anastomosis are desirable to make the procedure easier and more accessible. Improvements to compression anastomosis are also desirable from the perspective of the healing process, including reducing postoperative complications. [Means for solving the problem]

[0008] A first aspect provides a kit of parts forming a device for performing an anastomosis of a first gastrointestinal section and a second gastrointestinal section, the kit of parts comprising an inner ring defining a fecal passageway generally axially therethrough and having an outer surface facing generally opposite the passageway, and an outer ring defining a receiving volume for at least partially receiving the inner ring therein and having an inner surface facing at least partially towards the receiving volume, wherein in an assembled state in which the inner ring is at least partially disposed 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 and inner surfaces define an annular space therebetween, at least a portion of which converges in a generally axial direction. It will be understood that the annular space converging in a first axial direction is identical to the annular space diverging in a second axial direction opposite the first axial direction.

[0009] Generally, when the inner ring and the outer ring are said to be in an assembled state, it is meant that a portion of the first gastrointestinal section and a portion of the second gastrointestinal section are located between the inner ring and the outer ring, specifically in the annular space.

[0010] When the first gastrointestinal section and the second gastrointestinal section are between the inner ring and the outer ring, at least one of the inner ring and the outer ring is deformable. Thus, the shape of the annular space may be different depending on whether or not there is a gastrointestinal section between the inner ring and the outer ring.

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

[0012] The gastrointestinal tract is essentially a tubular layered structure consisting of three distinct layers of tissue: the peripheral layer, which is primarily made up of muscularis, the submucosa, which is primarily made up of collagen, and the luminal layer, which is primarily made up of mucosa.

[0013] The annular space can be positioned to accommodate a portion of both the first gastrointestinal section and the second gastrointestinal section. In particular, the annular space can be sized to accommodate the submucosa of both the first gastrointestinal section and the second gastrointestinal section.

[0014] In use, when the kit of parts is assembled by placing the inner ring at least partially within the receiving volume of the outer ring, the first gastrointestinal section and the second gastrointestinal section can be compressed between the inner and outer rings in the annular space. The inventors have found that application of sufficient pressure thins the peripheral and luminal layers, in particular shears away the peripheral and luminal layers, to the point where only the submucosal layer or substantially only the submucosal layer remains in at least a portion of the annular space.

[0015] Compression of the gastrointestinal section may be accomplished by the annular space between the inner and outer rings being insufficiently large to accommodate the entire thickness of the combined first and second gastrointestinal section in an uncompressed state, and in an assembled state, at least a portion of the annular space generally axially converges such that different amounts of compression may be applied to the first and second gastrointestinal section.

[0016] The amount of compression can increase generally axially, particularly downstream in the gastrointestinal tract. Thus, when considering the upstream direction, the amount of compression can approach or be near zero at some point. This may be true for one or both sides of the gastrointestinal section and / or one or more layers of the gastrointestinal section, such as the submucosa.

[0017] The thickness of most, or at least part, of the annular space in a radial direction perpendicular to the axial direction may be between 0.1 and 1.0 mm, in particular between 0.15 and 0.75 mm, or even between 0.3 and 0.5 mm.

[0018] The thickness of at least a portion, or even most 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 thickness of the radial annular space is 1.0 mm or less, particularly 0.5 mm or less, the submucosal layers of the first gastrointestinal section and the second gastrointestinal section can be placed in contact with each other, which advantageously allows for a first-intentional healing between the submucosal layers. It will be understood that a portion of the annular space may have a width less than 1.0 mm, while another portion of the annular space may have a width greater than 1.0 mm, with the annular space converging from this greater 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 section, particularly the thickness of the submucosa.

[0019] Specifically, as the width of the annular space decreases to 1.0 mm or less, or 0.5 mm or less, or even 0.3 mm or less, one or both of the serosal and mucosal layers, i.e., the peripheral and luminal layers, respectively, of the gastrointestinal tract section may be peeled or flaked away from the submucosal layer as the inner ring moves into the receiving volume of the outer ring. Additionally or alternatively, the reduction in thickness of the annular space may cause one or both of the serosal and mucosal layers to be crushed or disintegrated, exposing the submucosal layer.

[0020] In the assembled state, the inner and outer rings are positioned to define an annular space therebetween, such that other portions of the annular space may be greater than 0.5 mm, or greater than 1.0 mm thick. In use, as the inner ring moves further into the outer ring, narrowing the width of the annular space, the submucosa of the first gastrointestinal section and the second gastrointestinal section are positioned in contact with each other.

[0021] It has been observed that contact between the submucosal layers of the first and second gastrointestinal sections may improve healing between the first and second gastrointestinal sections and / or improve the stability of the anastomosis of the gastrointestinal sections in a patient, as compared to, for example, contact between only the serosal layers of both gastrointestinal sections. The submucosal layer has been observed to form the backbone of the gastrointestinal section, and thus anastomoses between the submucosal layers of the gastrointestinal sections may be preferred as an alternative to or in addition to anastomoses between serosal and / or mucosal layers.

[0022] Preferably, but not necessarily, the submucosal layers also contact the outside of the outer ring, e.g., axially outside the outer ring, e.g., above or below the outer ring. Outside the outer ring can mean outside the receiving volume of the outer ring and / or outside the inner diameter of the outer ring.

[0023] It will be appreciated that when the inner and outer rings are moved into an assembled state with the gastrointestinal tract section disposed between the inner and outer rings, one or both of the inner and outer rings may be elastically and / or plastically deformed. Thus, the desired shape and size of the annular space may only be achieved, by way of example, when the gastrointestinal tract section is disposed within the annular space. Thus, it will be appreciated that when the present disclosure refers to the inner and outer rings being in an assembled state, this may mean that the gastrointestinal tract section is disposed within the annular space.

[0024] Thus, in the assembled state, the two gastrointestinal section portions are arranged within an annular space, and the thickness of at least a portion of the annular space in a radial direction perpendicular to the axial direction is 0.5 mm or less, in particular 0.3 mm or less, such that in this assembled state the submucosal layers of the gastrointestinal section portions can come into contact with each other.

[0025] As a further option applicable to any kit of parts 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, in particular 0.5 mm or less, or even 0.3 mm or less for one part of the annular space, and 1.0 mm or more, or even 0.5 mm or more for another part of the annular space. These particular thicknesses allow the gastrointestinal sections to be compressed together, allowing contact of the submucosa.

[0026] Thus, it will be appreciated that any kit of parts disclosed herein, in any combination of any inner ring and any outer ring, can be arranged such that in an assembled state where portions of the gastrointestinal tract sections are disposed in the annular space, the thickness of the annular space perpendicular to the centerline of the annular space is 1.0 mm or less, in particular 0.5 mm or less, 0.3 mm or less for some portions of the annular space, and 0.5 mm or more, or even 1.0 mm or more for other portions of the annular space, such that the submucosal layers of the gastrointestinal tract sections are in contact with each other in the assembled state.

[0027] The direction of the fecal passageway through the inner ring may be generally defined as axial, as feces normally travels through the gastrointestinal tract in a downstream direction, and the outer surface of the inner ring facing away from the fecal passageway thus faces at least partially radially, where the radial direction is defined as being perpendicular to the axial direction.

[0028] In general, the inner ring may be substantially symmetrical, particularly rotationally symmetrical, about its centerline, and the outer ring may be substantially rotationally symmetrical, particularly rotationally symmetrical, about its centerline. 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 ring, may have a generally circular or donut-like shape, or may have any other shape, such as a generally oval or elliptical shape.

[0029] At least one of the outer surface of the inner ring and the inner surface of the outer ring may be provided by a rigid material that comprises at least one of each of the inner ring and the outer ring.

[0030] Generally, the term rigidity is used to mean that, upon use of the device to perform the anastomosis, the material that the device is made of does not undergo any deformation that would affect the use of the device. Common synthetic materials are metals, composites, and thermosets.

[0031] The opposite of a rigid material is an elastic material. The term elastic material means that the material made by the device is capable of being deformed when it is subjected to a force of the magnitude normally used in the device during use to perform the anastomosis. The material thus exhibits a certain stiffness, which is expressed in N / mm, i.e. the amount of force in newtons required for a certain deformation expressed in millimeters. When the force is no longer applied to the material, it at least partially elastically deforms and returns to its original shape. Thus, in the elastically deformed state, an elastic material is capable of exerting a force in a direction opposite to the direction of 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 a non-dispersing portion adjacent to the dispersing portion, the non-dispersing portion having a substantially constant cross-sectional area in a plane perpendicular to the axial direction.

[0033] The height of the annular space in a direction parallel to the axial direction may be between 4 and 20 mm, in particular between 4 and 6 mm, or at least more than 2 mm, or at least more than 4 mm, which may allow a sufficient portion of the first gastrointestinal section and the second gastrointestinal section to be compressed within the annular space.

[0034] Different types of connections may be used to connect the inner and outer rings. Preferably, during or after deployment, the inner and outer rings are connected to each other and to the gastrointestinal tract to prevent migration of one or both rings through the gastrointestinal tract, for example by peristalsis or passage of fecal matter through the rings.

[0035] In general, the connection between the inner ring and the outer ring may be a clamp connection, for example using an interference fit between the 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. For a clamp connection, one or both parts of the inner ring and the outer ring may be resilient.

[0036] A particular snap-fit ​​connection can be achieved when a portion of a first one of the inner and outer rings has a larger footprint than a portion of a second one of the inner and outer rings. The footprint can be envisioned in a top view perpendicular to a centerline of the inner and outer rings. When the inner ring is placed at least partially within the receiving volume of the outer ring, the larger portion of the footprint can get stuck behind the smaller portion of the footprint. A ring having an ellipsoidal inner and / or outer shape can have a larger footprint than a ring having a circular inner and / or outer shape.

[0037] A second aspect provides a method for performing an anastomosis of a first gastrointestinal section and a second gastrointestinal section, the method including the steps of placing an inner ring within the first gastrointestinal section so as to at least partially enclose the inner ring within the first gastrointestinal section, placing an outer ring within the second gastrointestinal section so as to at least partially enclose the outer ring within the second gastrointestinal section, and moving the inner ring axially into a receiving volume of the outer ring, where the inner ring is connected or becomes connected to the outer ring after the inner ring has been moved sufficiently into the receiving volume of the outer ring.

[0038] While moving the inner ring 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, and the annular space converges generally axially such that a portion of the first gastrointestinal section and a portion of the second gastrointestinal section are compressed together within the annular space.

[0039] The compressed portions of the first gastrointestinal section and a portion of the second gastrointestinal section are generally axially oriented because at least a portion of the annular space can also be generally axially oriented.

[0040] Specifically, after the inner ring moves into the receiving volume of the outer ring, a portion of the first gastrointestinal section and a portion of the second gastrointestinal section are present in said annular space, where primarily the submucosa is present, which may mean that a significant portion of the volume of the annular space filled with gastrointestinal tract is filled with submucosa, for example, more than 50%, or even more than 80%.

[0041] The peripheral and luminal layers may be more compressed than the submucosal layer, for example, due to the different material compositions of the layers: the material comprising the submucosa may have a higher stiffness to compression, and the thickness of the submucosal layer may decrease less under compression than the peripheral and luminal layers.

[0042] When the two gastrointestinal sections are compressed between the inner and outer rings, it is preferred that the submucosal layers of the two gastrointestinal sections are placed in contact with each other. Generally, contact between the submucosal layers may promote healing by primary intention. Healing by primary intention may increase the speed of the healing process and reduce the risk of leakage, infection, fibrosis, etc. Contact between the two submucosal layers may be achieved within the annular space or outside the annular space.

[0043] Additionally or alternatively, a substance such as a fluid may be forced or squeezed out of one or both of the peripheral and luminal layers, causing the thickness and / or volume of these two layers to decrease under compression. Additionally or alternatively, one or both of the peripheral and luminal layers may be peeled or flaked away from the submucosal layer, particularly as the inner ring moves into the receiving volume of the outer ring.

[0044] When the two gastrointestinal sections are compressed between the inner and outer rings, debris, bacteria, or any other material within the lumen of the gastrointestinal section can be pushed or displaced toward the centerline of the gastrointestinal section, corresponding to the passage of fecal matter through the inner ring, thus at least partially preventing debris, bacteria, or any other material from contacting the healing site where the two submucosal layers contact each other.

[0045] When the inner ring moves into the receiving volume of the outer ring, the outer ends of the first and second intestinal sections can be cut off. The cut off sections can exit the body through the anus. Cutting of the gastrointestinal sections can be performed by means of two interacting parts, the inner and outer rings. One or both of the interacting parts can have one or more sharp or serrated edges or surfaces, which can for example be pressed against the other of the interacting parts. The part of the gastrointestinal section located between the two interacting parts can thus be completely or partially cut or at least perforated.

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

[0047] Optionally, the kit of parts may include an auxiliary retaining ring that is positioned to cooperate with the anvil to cut the gastrointestinal section. In use, the auxiliary retaining ring may be positioned downstream of the outer ring at the second gastrointestinal section. The auxiliary retaining ring may include a sharp and / or serrated surface and / or edge. After the anvil passes the inner ring, the anvil may contact the sharp or serrated portion of the auxiliary retaining ring to cut the gastrointestinal section.

[0048] In an embodiment of the method, after the inner ring is moved into the receiving volume of the outer ring, the submucosal layers of the two gastrointestinal sections are placed in contact with each other, particularly around the entire circumference. Due to the shape of the annular space, the contacting portion of the submucosal layers is essentially isolated from bacteria originating from the mucosa and feces. Providing the muscular layers of the two gastrointestinal sections close to each other on the outside of the annular space may be preferable, as this may promote healing by first intention.

[0049] A third aspect provides a deployment device for deploying a device comprising an inner ring and an outer ring for performing an anastomosis between a first gastrointestinal section and a second gastrointestinal section.

[0050] It will be appreciated that the method according to the second aspect may be carried out using components of a kit of parts according to the first aspect and / or using a placement apparatus according to the third aspect, thus optional features disclosed in relation to one of the aspects may be readily applied to embodiments of the other two aspects. [Brief description of the drawings]

[0051] [Figure 1A] FIG. 2 is a top view adjacent to a perspective view of a first embodiment of a kit of parts. [Figure 1B] FIG. 1B is a cross-sectional view taken along line AA in the top view of FIG. 1A. [Diagram 2] FIG. 2 is a schematic diagram of the kit of parts of FIGS. 1A and 1B in an unassembled state. [Figure 3A]1A-1D illustrate different stages of a method for performing an anastomosis of a first gastrointestinal section and a second gastrointestinal section. [Figure 3B] 1A-1D illustrate different stages of a method for performing an anastomosis of a first gastrointestinal section and a second gastrointestinal section. [Figure 3C] 1A-1D illustrate different stages of a method for performing an anastomosis of a first gastrointestinal section and a second gastrointestinal section. [Figure 4A] FIG. 13 shows a second embodiment of a kit of parts for forming a device for performing an anastomosis. [Figure 4B] FIG. 13 shows a second embodiment of a kit of parts for forming a device for performing an anastomosis. [Figure 4C] FIG. 13 shows a second embodiment of a kit of parts for forming a device for performing an anastomosis. [Figure 5A] FIG. 1 is a perspective view of a deployment device for deploying a device for performing an anastomosis of two gastrointestinal sections. [Figure 5B] FIG. 1 is a perspective view of a deployment device for deploying a device for performing an anastomosis of two gastrointestinal sections. [Figure 6A] 1 illustrates an embodiment of a portion of a deployment device. [Figure 6B] 13A-13C show different cross sections of the deployment device. [Figure 7A] 13A-13C show different cross sections of the deployment device. [Figure 7B] 13A-13C show different cross sections of the deployment device. [Figure 7C] 13A-13C show different cross sections of the deployment device. [Figure 7D] 13A-13C show different cross sections of the deployment device. [Figure 8] FIG. 3C is a detailed view of FIG. [Figure 9] Color photographs of an experiment in which two gastrointestinal sections were compressed into the annular space between the outer and inner rings. [Figure 10] This is a monochrome version of the photograph in Figure 9. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] Figure 1A shows a top view adjacent to a perspective view in an assembled state of a first embodiment of a kit of parts forming a device for performing an anastomosis of a first gastrointestinal section to a second gastrointestinal section, and Figure 1B shows a cross-sectional view indicated at AA in the top view of Figure 1A.

[0053] The kit of parts includes an embodiment of an inner ring 100 that defines a passageway 102 for the passage of feces. The inner ring 100 includes an outer surface 101 that generally faces away from the passageway 102.

[0054] 1A and 1B further includes an outer ring 200 defining a receiving volume 202 for receiving at least a portion of the inner ring. The outer ring 200 includes an inner surface 201 that at least partially faces towards the receiving volume 202.

[0055] 1B, in the assembled state, an inner surface 201 of the outer ring 200 faces towards the inner ring 100. An outer surface 101 of the inner ring 100 faces towards the outer ring 200. In particular, the outer surface 101 at least partially faces the inner surface 201.

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

[0057] In an assembled state, 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, as shown, for example, in FIG. 1B.

[0058] 1B, the outer ring 200 may optionally include an inner flange 203 that faces toward, or even projects into, the fecal passageway 102. Specifically, the inner flange 203 may have a smaller inner diameter than one or more portions of the inner surface 201 of the outer ring 200 adjacent the inner flange 203.

[0059] The inner diameter of the inner flange 203 corresponds to the outer diameter of a portion of the outer surface 101 of the inner ring 100. Corresponding in this context may mean one of an interference fit, a light interference fit, or a loose fit between the inner flange 203 and the inner ring 100. One or both faces that contact the inner flange 203 with the adjacent portion of the inner surface 201 of the outer ring may be rounded, chamfered, or at least partially oriented obliquely relative to the radial direction.

[0060] Although the inner flange 203 is depicted in FIGS. 1A and 1B as being defined by the outer ring 200, in addition to or as an alternative to the inner flange 203, the inner ring 100 may include an outer flange.

[0061] In any embodiment of the kit of parts, when a fit, such as an interference fit, is provided between the inner ring 100 and the outer ring 200, the inner flange 203 can reduce or even prevent leakage of feces between the inner ring 100 and the outer ring 200.

[0062] 1B, and which is applicable to any embodiment of the kit of parts, is for a portion 300' of the annular space 300 to have 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 kit of parts of Figures 1A and 1B in an unassembled state. The inner ring 100 is placed in a first gastrointestinal section 301, which may be a proximal gastrointestinal section. The outer ring 200 is placed in a second gastrointestinal section 302, which may be a distal gastrointestinal section. The gastrointestinal sections may be at least partially closed, for example, using purse string sutures to partially close each gastrointestinal section.

[0064] 3A, 3B, and 3C illustrate different stages of a method for performing an anastomosis of a first gastrointestinal section 301 and a second gastrointestinal section 302. As shown generally in FIGS. 3A, 3B, and 3C, the gastrointestinal section generally includes a peripheral layer 311 of muscularis, a luminal layer 313 of mucosa, and a submucosal layer 312 between the peripheral layer 311 and the luminal layer 313.

[0065] In a first step of the method shown in Figure 3A, an embodiment of the inner ring 100 is placed within a first gastrointestinal section 301 and an embodiment of the outer ring 200 is placed within a second gastrointestinal section 302. The gastrointestinal sections at least partially surround the inner and outer rings, respectively, as seen in Figure 2. Thus, for example, when the inner ring 100 is moved axially, the first gastrointestinal section 301 also moves axially with the inner ring. The inner and outer rings can be configured to slide or telescope one into the other.

[0066] 3B and 3C, in a second step of the method, the inner ring 100 is moved axially 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. A portion of the first gastrointestinal section 301 and a portion of the second gastrointestinal section 302 are pressed into the annular space 300. This annular space 300 can thus have a radial thickness that is smaller than the thickness of the two gastrointestinal sections.

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

[0068] Portions of gastrointestinal cutting portion 301' and gastrointestinal cutting portion 302' can be cut off by an engagement between inner flange 203 of outer ring 200 and inner ring 100, or by a separate cutting portion formed by one or both of the inner and outer rings.

[0069] 3C, for example, due to a particular radial thickness of the annular space 300, the submucosal layer 312 resides primarily within the annular space 300. In the annular space 300, the peripheral layer 311 and / or the luminal layer 313 may be more compressed than the submucosal layer 312.

[0070] Due to the divergent, tapered, and / or funnel-like shape of the annular space, different amounts of compression can usually be achieved in different portions of the GI tract. For example, at or near the widest portion of the annular space, the GI tract is little or not compressed at all, while the narrower portions of the annular space experience increased compression. At or near portions of the annular space where the GI tract is little or not compressed, uncompressed submucosa can be in close proximity. Moving further into the narrower portion of the annular space, the two submucosa layers can be progressively compressed.

[0071] 4A, 4B and 4C show a second embodiment of a kit of parts for forming a device for performing an anastomosis, respectively in a top view, a perspective view and a cross-sectional view along the plane AA of FIG. 3A.

[0072] The second embodiment of the kit of parts comprises an inner ring 100 and an outer ring 200 , the inner ring 100 defining a fecal passageway 102 and the outer ring defining a receiving volume 202 for receiving at least a portion of the outer ring 200 .

[0073] The kit of parts in Figures 4A, 4B and 4C is shown in an assembled state. Thus, an 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 centerline 105, specifically in the downstream axial direction. In other words, the annular space 300 diverges in the axial upstream direction.

[0074] As a particular option, for example as shown in Fig. 4C, the outer ring includes an inwardly facing shoulder 204 as an example of an inner flange. The inner ring 100 includes an outwardly facing shoulder 104. In the assembled state, the inwardly facing shoulder 204 is specifically oriented at an angle to the centerline 105, for example disposed to abut the outwardly facing shoulder 104 in a plane that is generally perpendicular to the centerline 105, i.e. radially thereto.

[0075] As a further option, as shown, for example, in Figure 4C, the inward shoulder 204 of the outer ring 200 may be provided with one or more serrations 206 projecting from a surface 208 of the inward shoulder 204 that faces at least partially axially, i.e., parallel to the centerline 105. The serrations 206 may cut or at least pierce the gastrointestinal section.

[0076] 5A and 5B are two perspective views of a deployment device for deploying the device to perform an anastomosis of two gastrointestinal sections.

[0077] The deployment device 400 includes a housing 402, which may be flexible in the sense that a surgeon can at least partially manipulate the shape of the housing 402. For example, the housing 402 may be made up of multiple hinged or rotatably connected sections that can hinge or rotate relative to one another.

[0078] The deployment device 400 comprises, at the distal end 401 of the housing 402, a translatable element 404 adapted to be connected to an inner ring of the anastomosis device, the translatable element being arranged to translate on a translation axis 406. At its distal end, the translatable element 404 may be provided with a connecting element 414 for connecting to the inner ring. The connecting element 414 may be a thickened element with respect to the translatable element 404, i.e. 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 deployment device 400 includes an actuator 408 adapted to rotate about a rotation axis 410. The rotation axis is disposed obliquely relative to the translation axis 406. In particular, the rotation axis can be disposed 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 further comprises a coupling device adapted to convert a rotation of the actuator into a translation of the translatable element 404, for example using a rack and pinion mechanism, a threaded spindle, a cycloidal gearing, or any other threaded mechanism, for connecting the actuator 410 to the translatable element 404. The coupling device may be disposed within the housing 402 or covered by the housing, and is therefore not visible in Figures 5A, 5B. An actuator should be understood as a component that is arranged to receive a force and / or torque input, for example from a surgeon. An actuator may also be referred to as an actuatable element.

[0081] The transmission can be, for example, a coupling including one or more gears, racks, or any other rotational transmission elements. The transmission can be used to convert the rotational speed of the actuator to a lower speed of the translatable element, thereby reducing the torque required to rotate the actuator. For example, the transmission can have a gear ratio of 32:1 or more, 16:1 or more, or even 2:1 or more.

[0082] Optionally, the deployment device 400 further comprises a handle 412, which can be positioned opposite the actuator 408. As such, the rotation axis 410 can extend through a portion of the handle 412. The handle 412 is connected to the housing at the proximal end 403 of the housing.

[0083] At least a portion of the handle 412 may be in the shape of at least a portion of an ellipsoid, particularly a triaxial ellipsoid, and particularly half or more of an ellipsoid, such that the handle 412 can be conveniently held by hands of different sizes.

[0084] When the device is in use, the deployment device 400 can have its distal end 401 inserted into a patient, for example via the patient's anus. When in use, the proximal end 403 of the deployment device 400 can be located outside the patient's body, for example allowing actuator 408 to be actuated by a surgeon.

[0085] Figure 6A illustrates in perspective view one embodiment of an end effector 416 of a deployment device, such as the deployment device shown in Figure 5 A. The end effector 416 includes a connecting element 414 for connecting to the translatable element 404 and the inner ring.

[0086] Figure 6B illustrates, in cross-section, a schematic of the end effector 416 of Figure 6A with the inner ring 100 connected to the connecting element 414 and the outer ring 200 connected to the end effector body 418. As can be seen in Figure 6B, the inner ring 100 can be moved towards and into the outer ring 200 by moving the translatable element 404 and, with it, the connecting element 414.

[0087] The deployment device optionally includes a cutting ring 420, which may include a sharp cutting edge or serrated end, as shown in FIG. 6A, for example. The serrations on the serrated end allow the gastrointestinal portion to be severed. The outer ring 200 may be secured to the cutting ring 420, which in turn may be secured to the end effector 416 of the deployment device.

[0088] 7A-7D show a schematic diagram in four steps of how to position the inner ring 100 and the outer ring 200 to perform the anastomosis. For clarity, the gastrointestinal tract is not shown.

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

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

[0091] 7C shows a third step in which the translatable element 404 is further pulled down. As a particular option, the connecting element 414 to which the inner ring 100 is connected comprises a flexible crown 422. In the first and second steps, the flexible crown 422 allows the inner ring 100 to be pulled down into the outer ring 200. The amount of 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 inwards, thereby sliding through the inner ring 100.

[0092] Flexible crown 422 may be comprised of multiple hinged fingers, for example as shown in Figures 7A-7D, or may generally be comprised of any resilient or flexible material that allows deformation of flexible crown 422. Deformation may be elastic and / or plastic. For example, one or more fingers may break to allow passage of connecting element 414 through inner ring 100.

[0093] 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 to sever a portion of the gastrointestinal section. The connecting element 414 can thus act as a cutting anvil.

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

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

[0096] 8 and other figures, and which is readily applicable to any of the embodiments of the inner ring 100 disclosed herein, the inner ring 100 may have an outwardly protruding shoulder 180. A portion of the outer surface 101 of the inner ring 100 is configured with the shoulder 180, which, in use, may contact the luminal layer 383 of the first gastrointestinal section 301. In general, any shoulder disclosed herein may alternatively be referred to as a flange or radial extension.

[0097] 8, the shoulder 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 180 may extend radially further. For example, the outwardly projecting shoulder 180 of the inner ring 100 can extend beyond the inner surface of the outer ring 200. (See FIG. 1B.) In other examples, the outwardly projecting shoulder 180 of the inner ring 100 can extend 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 certain dimensions of the inner ring 100 and the outer ring 200 may be beneficial to the healing process between the gastrointestinal sections and / or the stability of the inner and outer rings within the gastrointestinal tract and / or the strength of the anastomosis. In particular, the dimensions of the inner ring 100 and the outer ring 200 are preferably selected to allow contact between the submucosa 312 of the gastrointestinal section and the submucosa 382 during use. The contact surface area between the submucosa 312 and the submucosa 382 can be created or increased by several dimensions of the inner and outer rings.

[0099] Preferably, the width W of the portion of the annular space 300 min The minimum thickness, also called the thickness of the conductor, is 0.5 mm or less, particularly 0.3 mm or less. This minimum thickness is H p It is preferable that the height H p The height H may be between 1.0 and 5.0 mm, and in particular between 1.0 and 2.0 mm. p Throughout, the width of the annular space 300 may be substantially constant. A further portion of the annular space may be narrowed by, for example, the inner flange 203 of the outer ring 200, to a width W min There may be a width smaller than 1.0 to 5.0 mm. p However, it was observed that the gastrointestinal tract section prevented sliding out of the annular space between the inner and outer rings.

[0100] In the example of Figure 8, the width W min is achieved over the axially parallel portion of the annular space 300, where width W min It will also be appreciated that embodiments of the inner and outer rings are contemplated in which the portion of the annular space 300 in which the minimum width or thickness W is realized is oriented obliquely relative to the axial direction. min may be considered to be in a direction perpendicular to the inner surface of the inner ring, perpendicular to the inner surface of the outer ring, or perpendicular to both if the outer and inner surfaces are oriented parallel.

[0101] The axial height of the outer ring 200 contributing to the annular space 300 is H o When in an assembled condition, a portion of the inner ring 100, such as, but not limited to, the outwardly projecting shoulder 180, extends axially beyond the outer ring 200 and is denoted as H o +H s Preferably, the inner ring 100 further defines an annular space 300 having a total height of H o is between 2.0 and 6.0 mm, particularly between 2.0 and 3.0 mm, and the height H s is between 1.5 and 2.5 mm, especially between 1.75 and 2.25 mm.

[0102] The annular space 300, which generally converges in an axial direction, particularly in a downward direction, has a thickness T c The combined wall thickness of the two gastrointestinal sections, referred to as T, gradually decreases as the tubing sections are compressed within the annular space 300 as the inner ring moves into the outer ring. c is the sum of the wall thicknesses t of the two gastrointestinal sections in the uncompressed state, minus the minimum width W min , or below where the gastrointestinal section is severed (see, for example, sections 301' and 302' in FIG. 3C). The total wall thickness of the gastrointestinal section in the uncompressed state is generally T max It is called T max is approximately equal to twice t. It will be appreciated that the wall thickness of the gastrointestinal tract, shown as thickness t in FIG. 8, may vary from person to person.

[0103] For example, the wall thickness of the gastrointestinal tract is typically about 2.25 mm, i.e., 2.0-2.5 mm, for an adult colon. Depending on a person's age and physical condition, the wall thickness of the gastrointestinal tract may be 1.5-3.0 mm. However, it will be appreciated that pathology and / or certain treatments, such as radiation therapy, may cause the wall thickness of the gastrointestinal tract to exceed 3.0 mm. Thus, the kit of parts may have a thickness T perpendicular to the centerline of the annular space depending on the wall thickness of the gastrointestinal section to be anastomotic. aIt may be formed using inner and outer rings of particular size to define an annular space having a diameter of 1.5 mm or less, 1.0 mm or less, 0.5 mm or less, and particularly between 1.5 mm and 0.05 mm.

[0104] A person skilled in the art will understand that a gastrointestinal section may generally have projections and / or segments that fold over themselves. Thus, the wall thicknesses defined herein may apply to a gastrointestinal section that is stretched, for example, by an inner or outer ring inserted into the gastrointestinal section. Typically, the outer diameter of the outer ring may range from 20 mm to 40 mm, in particular from 25 mm to 35 mm.

[0105] It will be appreciated that aspects and embodiments of the present disclosure may be used to anastomose any type of gastrointestinal section, including, but not limited to, the esophagus, intestine, small intestine, large intestine, and any other gastrointestinal section.

[0106] T max and W min It has been observed that there is an optimal or at least favorable spot or range, also called the sweet spot or sweet range, between the W and the W. In this spot or range, it has been found that healing by primary intention occurs between the submucosa of the gastrointestinal tract section. min <T c <T max an optimal or at least advantageous thickness T perpendicular to at least one gastrointestinal section, c is between 0.2 mm and 3.5 mm. It is therefore preferred that at least a portion of the annular space is dimensioned such that, in an assembled state with the two gastrointestinal tract sections disposed in the annular space, the gastrointestinal tract sections are compressed to a thickness between 0.2 mm and 3.5 mm, in particular between 0.5 mm and 2.5 mm.

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

[0108] A centerline can be defined for any annular space of any kit of parts including inner and outer rings disclosed herein. For example, in Figures 1B, 4C, and 10, the centerline is shown by dashed line c. From any point on the 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 defines the thickness T of the annular space 300. a It is called the thickness T a Examples of the thickness T are shown in Figs. 1B, 4C, 9 and 10. When two gastrointestinal sections are placed in the annular space and assembled with an inner ring and an outer ring, the thickness T a is the thickness T c , i.e., corresponds to the combined thickness of the compressed gastrointestinal sections.

[0109] In use, the contact area A between the two gastrointestinal sections will generally follow this centerline when the two gastrointestinal sections are within the annular space 300, especially if the gastrointestinal sections are of similar stiffness. In practical examples, the deviation between the contact area A and the centerline in at least a portion of the annular space 300 between the two gastrointestinal sections may be, for example, ±10%, or ±20% or more.

[0110] In any embodiment of the kit of parts 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 centerline c is a may range between 0.0 mm and 10.0 mm, or between 0.0 mm and 5.0 mm. a -defined perpendicular to the centerline c -at least a portion of the centerline c.

[0111] In an assembled state in which the gastrointestinal section is in the annular space, when at least one of the outer ring and the inner ring is deformed, the shape of the center line c and the thickness T at different positions along the center line c are a It will be appreciated that may be affected by the presence of a gastrointestinal tract cut within the annular space.

[0112] 8, a portion of the second gastrointestinal section 302 is bent radially inward and protrudes into the annular space. The portion of the second gastrointestinal section 302 within the annular space can be considered to be inverted relative to the remainder of the second gastrointestinal section 302. Specifically, the portion of the second gastrointestinal section 302 is bent onto the outer ring 200, onto a curved upper portion 280 of the outer ring 200. The curvature of this upper portion 280 can be designed to achieve a desired shape of the converging portion of the annular space 300.

[0113] Figure 9 shows a photograph of an experiment in which two gastrointestinal sections 301, 302 were compressed into an annular space 300 formed by moving an inner ring 100 into an 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 made up by the gastrointestinal sections 301, 302 - namely, peripheral layer 311, 381, submucosal layer 312, 382 and luminal mucosal layer 313, 383.

[0114] In Figure 9, the shape of the inner and outer rings can be identified by the shape of the deformed gastrointestinal sections 301, 302. To further clarify the shape of the inner ring 100 and the outer ring 200, the ring outlines are shown in dashed lines in Figure 10. The inner and outer rings shown assembled in Figures 9 and 10 form an annular space having a thickness T perpendicular to a centerline c that is less than 1.0 mm in some parts of the annular space and greater than 1.0 mm in other parts of the annular space. a has.

[0115] As shown in Figure 9, at a particular point c' on the centerline c of the annular space 300, the submucosal layers 312, 382 come into contact due to the compression of the peripheral layers 311, 381, exposing the submucosal layers. a ' and may range between 0.5 mm and 3.5 mm, in particular between 1.0 mm and 2.5 mm.

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

[0117] It will be understood that in the above description, an element is connected to another element, either that the element is directly connected to the other element or that intervening elements may also be present. It will also be understood that the values ​​given in the above description are given as examples, and that other values ​​may be possible and / or aimed for.

[0118] It should be noted that the figures are merely schematic representations of embodiments given as non-limiting examples. Although features are described herein as part of the same or separate embodiments for clarity and conciseness of description, it will be understood that the scope of the disclosure may include embodiments having all or some combination of the described features.

[0119] The term "comprising" does not exclude the presence of other features or steps. Moreover, "a" or "an" should not be considered as being limited to "only one" but is used to mean "at least one" and does not exclude a plurality.

Claims

1. 1. A kit of parts for forming a device for performing an anastomosis between a first gastrointestinal section and a second gastrointestinal section, said kit of parts comprising: an inner ring defining a fecal passageway generally axially therethrough and having an outer surface facing generally opposite the passageway; an outer ring defining a receiving volume for at least partially receiving the inner ring therein and having an inner surface at least partially facing toward the receiving volume; Equipped with the inner ring and the outer ring, in an assembled state in which the inner ring is at least partially positioned within the receiving volume of the outer ring, have at least a portion of the outer surface of the inner ring facing the inner surface of the outer ring, and the outer surface and the inner surface define an annular space therebetween; At least a portion of the annular space generally converges in an axial direction.

2. In the assembled state, the thickness (W) of at least a portion of the annular space in a radial direction perpendicular to the axial direction ｍｉｎ 2. The kit of parts according to claim 1, wherein the thickness of the first and second electrodes is 1.0 mm or less, in particular 0.5 mm or less, or even 0.3 mm or less.

3. In the assembled state in which portions of the two gastrointestinal tract sections are disposed in the annular space, the thickness (W) of at least a portion of the annular space in a radial direction perpendicular to the axial direction is ｍｉｎ 2. The kit of parts according to claim 1, wherein the thickness of the first and second sections of the gastrointestinal tract is 1 mm or less, in particular 0.5 mm or less, and more particularly 0.3 mm or less, so that the submucosal layers of the gastrointestinal tract sections are in contact with each other in the assembled state.

4. In the assembled state, the thickness (T) of the annular space perpendicular to the center line (c) of the annular space ａ 2. The kit of parts of claim 1, wherein the distance between the annular space and the outer surface of the annular space is 0.5 mm or less, or 0.3 mm or less for one portion of the annular space, and 1.0 mm or more for another portion of the annular space.

5. In the assembled state in which the two gastrointestinal section portions are placed in the annular space, the thickness (T ａ 2. The kit of parts of claim 1, wherein the gap between the annular space and the submucosa of the gastrointestinal section is 1.0 mm or less, or even 0.5 mm or less, or 0.3 mm or less for one portion of the annular space, and 1.0 mm or more for another portion of the annular space, such that the submucosa of the gastrointestinal section is in contact with each other in the assembled state.

6. The kit of parts of claim 1 , wherein at least one of the outer surface and the inner surface is provided by a rigid material comprising at least one of the inner ring and the outer ring, respectively.

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

8. 2. Kit of parts according to claim 1, wherein the height of the annular space in a direction parallel to the axial direction is between 2 and 20 mm, in particular between 4 and 6 mm.

9. 10. The kit of parts of claim 1, wherein the outer ring comprises an inner flange that projects toward the fecal passage.

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

11. 2. The kit of parts of claim 1, wherein the outer ring includes an inwardly facing shoulder and the inner ring includes an outwardly facing shoulder, the inwardly facing shoulder being positioned to abut the outwardly facing shoulder in the assembled state.

12. 12. The kit of parts according to claim 11, wherein the inwardly facing shoulder of the outer ring is provided with one or more serrations projecting from a surface of the inwardly facing shoulder, the surface facing at least partially in the axial direction.

13. The kit of parts of claim 1 , wherein the inner ring includes an outwardly projecting shoulder.

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

15. 2. The kit of parts of claim 1, wherein the outer ring has a height that is less than the inner ring when the inner ring is aligned with an end of the outer ring.

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