Connectors and devices for anastomosis

Abstract

A connector (100) for connecting two anastomotic devices, the connector having a generally hollow open structure, the connector (100) comprises a tubular portion (101) centrally located on the axis of the connector (100), a first end (102) extending axially from the tubular portion (101) in a first direction, the first end (102) comprising at least one continuous or discontinuous circumferential flange (106) and / or at least one continuous or discontinuous circumferential groove (106') extending radially outward from the first end (102), and a second end (103) extending axially from the tubular portion (101) in a second direction. The connector (100) is used to connect two devices (200) for placement on the side wall of the intestine (I). The device for anastomosis of tubular structures comprises a connector and a device for placement on the side wall of the intestine (I).

Description

Technical Field

[0001] The present invention relates to the anastomosis of biological tissues, more specifically, a connector for connecting two anastomosis devices, as well as a device for placement on the side wall or end of the intestine, and a device for the anastomosis of tubular structures.

[0002] Furthermore, the present invention relates to a method for attaching such a device to a tubular structure.

Background Art

[0003] Colorectal cancer is the third most common type of cancer in the world, with approximately 1 million new cases occurring annually. The incidence of this cancer is quite high in industrial regions around the world.

[0004] Current techniques for mechanically performing the anastomosis of hollow organs use circular mechanical staplers, which connect the tissue ends of the hollow organs cut open by metal or plastic staples. A variety of surgical staplers have been developed for surgeries on the stomach, esophagus, and intestine. When performing surgical anastomosis suturing, usually, two locations of the hollow organ are joined by a staple ring using a closed-loop stapler. End-to-end anastomosis is usually performed by an intraluminal surgical stapler that delivers a pair of staggered staple rings. During this process, a circular knife blade is used to separate the tissue held within the circular ring. The separated tissue is then removed using a stapler to form a circular opening within the lumen along the suture line.

[0005] A major challenge in the healing of anastomoses is blood circulation at the anastomosis site during the healing process. Despite significant advances in surgical techniques over the past few decades, the complication and mortality rates after gastrointestinal resection, for example due to anastomotic leakage, remain serious problems. Ischemia and inflammation, which are natural parts of the healing process, can cause leakage and secondary infection at the suture site, which can be fatal for the patient. Therefore, especially when performing anastomoses in the lower colon and rectum, it has become common practice to reduce pressure from the anastomosis site by creating a deviating stoma. By reducing pressure and stool flow from the anastomosis site during the healing process, leakage incidents can be reduced, and the fatal consequences of anastomotic dehiscence can be avoided. The inconvenience for the patient is clear, as they must require a temporary stoma for a period of approximately 3-6 months, after which they must undergo a second surgery to close the stoma. Unfortunately, in many cases, stoma closure is irreversible, forcing the patient to live with a permanent stoma, which leads to increased costs and a reduced quality of life.

[0006] Furthermore, if the surgical stapler forms a smaller, more rigid opening compared to the cross-section of the original lumen due to the staples within the hollow structure connecting the two ends, i.e., a collar that may be formed that could cause stenosis, the risk of anastomotic stricture increases.

[0007] Therefore, in the art, there has been a need to develop assemblies that overcome these shortcomings. Such assemblies are disclosed in International Publication Nos. 2007122223 and 2014031065, which disclose assemblies comprising connecting members for use in achieving anastomosis of tubular organs. This assembly comprises two rigid parts on which two elastic rings are positioned, with each rigid part and its corresponding elastic part fixing the end of the intestine, and then the rigid parts are connected to each other via connecting members. However, The use of such open-end anastomosis rings is often required for tumors that are difficult to access, but it is challenging to connect one side of the intestine to another side or open end. [Overview of the project]

[0008] Accordingly, the present invention preferably aims to mitigate, alleviate, or eliminate one or more of the drawbacks and disadvantages identified above in the art, either individually or in any combination, by providing a connector for connecting two anastomotic devices, the connector comprising: a tubular portion having a generally hollow open structure and centrally located on the axis of the connector; a first end extending axially from the tubular portion in a first direction, the first end comprising at least one continuous or discontinuous circumferential flange extending radially outward from the first end, and / or at least one continuous or discontinuous circumferential groove extending radially inward from the first end; and a second end extending axially from the tubular portion in a second direction, thereby solving at least the above-mentioned problems.

[0009] Such connectors provide versatile connectivity in difficult-to-access areas of the intestine.

[0010] The connector may consist of a single part. Preferably, the connector consists of at least two parts, or more preferably at least three parts. Connectors consisting of separate parts facilitate the formation of a gap between the flange and the tubular portion along the cross-section relative to the axial extension of the tubular portion, since the parts may be injection-molded later. After the separate parts are manufactured, the parts are assembled into a connector.

[0011] A device is also provided for placement on the side wall of the intestine or on the end of the intestine, the device comprising a first member and a second member, the first member comprising an elastic portion having a first axial end and a second axial end, and a rigid support portion disposed at the first axial end of the elastic portion, the second member comprising a first axial end and a second axial end, the first end of the second member conforming to the shape of the second axial end of the elastic portion so that the intestinal wall is uniformly distributed between the second axial end of the elastic portion and the second member, and at least one connecting member for connecting the rigid support portion and the second member, the at least one connecting member comprising a pin receiving means, the second member comprising at least one circumferential groove disposed on the inner surface of the second member located radially inward, and / or at least one groove disposed on the inner surface of the second member located radially outward, for locking interaction with at least one flange on the connector according to the present disclosure.

[0012] A device for anastomosis of tubular structures is also provided, the device comprising a connector according to the present disclosure, a device or configuration on the side wall of the intestine or on the end of the intestine as disclosed above, and at least one pin.

[0013] A device for placement on the side wall of the intestine or on the end of the intestine is also provided, the device comprising a member, the member comprising an elastic portion having a first axial end and a second axial end, and a rigid support portion disposed at the second axial end of the elastic portion, wherein the first axial end of the elastic portion conforms to the shape of the radial projection of the connector according to this disclosure so that the intestinal wall is uniformly distributed between the first axial end of the elastic portion and the radial projection of the connector, and the second end further comprises at least one connecting member, the at least one connecting member comprising a pin receiving means.

[0014] A device for anastomosis of tubular structures is also provided, comprising a connector according to the Disclosure and a device for placement on the side wall of the intestine or on the end of the intestine according to the Disclosure.

[0015] A method is also provided for attaching a device for anastomosis of tubular structures according to the present disclosure to a tubular structure having a first end and a second end to be connected, the method comprising the steps of: positioning a first device on the first end of the tubular structure, wherein the first device is a device for positioning on the side wall of the intestine or on the end of the intestine according to the present disclosure; connecting the connector according to the present disclosure to the first device; positioning a second device on the second end of the tubular structure, wherein the second device is a device according to the present disclosure; and connecting the connector to the second device. Optionally, a catheter can enter the lumen of the tubular structure through the first device.

[0016] Further objects, features, and advantages of the present invention will become apparent from the following detailed description, the accompanying drawings, and the dependent claims.

[0017] In the claims, the term “comprises / comprising” does not preclude the existence of other elements or steps. Furthermore, although individually listed, multiple means, elements, or steps of method may be performed. In addition, individual features may be included in different embodiments, but they may be combined in other ways, and inclusion in different embodiments does not mean that the combination of features is not feasible. Also, singular references do not preclude plurals. The terms “a” and “an” do not preclude plurals. Reference numerals in the claims are provided merely as illustrative examples for clarity and should not be construed as limiting the claims in any way. [Brief explanation of the drawing]

[0018] These and other aspects, features and advantages of the present invention will become apparent and clarified from the details of the following embodiments of the present invention with reference to the accompanying drawings.

[0019] [Figure 1a] Perspective view of a connector according to an embodiment of the present disclosure. [Figure 1b] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 1c] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 1d] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 2a] Perspective view of a connector according to an embodiment of the present disclosure. [Figure 2b] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 3a] Perspective view of a connector according to an embodiment of the present disclosure. [Figure 3b] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 3c] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 4] Perspective view of a connector according to an embodiment of the present disclosure. [Figure 5a] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 5b] Cross-sectional view of a connector according to an embodiment of the present disclosure. [Figure 6a] Cross-sectional view and exploded view of a device according to an embodiment of the present disclosure. [Figure 6b] Cross-sectional view of a second member of a device according to an embodiment of the present disclosure. [Figure 6c] Cross-sectional view of a connector according to an embodiment of the present disclosure, interacting in a locking manner with a second member of a device according to an embodiment of the present disclosure. [Figure 7] Cross-sectional view of a device for anastomosis according to an embodiment of the present disclosure, attached in a tubular structure. [Figure 8a] Cross-sectional view and exploded view of a device according to an embodiment of the present disclosure. [Figure 8b] Cross-sectional view and exploded view of a connector according to an embodiment of the present disclosure and a device according to an embodiment of the present disclosure. [Figure 9] This is a cross-sectional view of a device for anastomosis according to one embodiment of the present disclosure, attached by a tubular structure. [Modes for carrying out the invention]

[0020] Several embodiments of the present invention are described below with reference to the drawings, so that those skilled in the art can carry out the invention. However, the features and steps of the method included in these embodiments are not limiting to the present invention. Furthermore, the features and steps of the method can be combined in ways other than those specifically described.

[0021] Figures 1 to 5 show different embodiments of connectors for connecting two anastomosis devices.

[0022] When forming an anastomosis between two ends of a tubular structure such as the intestine, devices 200, 300 are placed on the side wall of the intestine or on the end of the intestine. The two devices 200, 300, which are placed on the side wall of the intestine or on the end of the intestine, are connected by a connector 100. The two devices used at both ends of the tubular structure to be connected may be devices 200 of the same type (see Figure 7). In such a case, the connector 100 is symmetrical or essentially symmetrical, as shown, for example, in Figures 2 and 3. The two devices used at both ends of the tubular structure to be connected may be two different devices 200, 300 (see Figure 9). In such a case, the connector 100 is asymmetrical, as shown, for example, in Figures 4 and 5.

[0023] When an anastomosis is formed between the ends of a tubular structure, the ends are the remaining ends of the intestine from which the portion between the ends has been removed. The openings at both ends may be joined to the opening, the sides to the sides, or the sides to the opening.

[0024] Figures 1a to 1d show the connector 100 according to the present disclosure. The connector 100 has a generally hollow, open structure when positioned on the side wall of the intestine or on the end of the intestine.

[0025] The connector 100 may be made of a polymer material, more specifically a biocompatible material, and most specifically a biodegradable material.

[0026] The connector 100 may be composed of a single component.

[0027] Preferably, as shown in Figures 1c, 3c, 5b, 6a, and 6b, the connector 100 is composed of at least two parts, or more preferably at least three parts. The connector 100, composed of separate parts, facilitates the formation of the gap 112. After the separate parts are manufactured, the parts are assembled into the connector 100.

[0028] The connector has a generally hollow, open structure and includes a tubular portion 101 that is centrally located on the axis of the connector 100.

[0029] The first end 102 extends axially from the tubular portion 101 in a first direction. The first end 102 comprises at least one circumferential flange 106 extending radially outward from the first end 102. The flange 106 may be continuous or discontinuous; that is, it may be a single homogeneous flange extending radially around the tubular portion 101, or it may comprise radially arranged flange segments around the tubular portion 101. Preferably, the flange 106 is flexible, which facilitates the connection of the connector 100 to devices 200, 200', 300 for placement on the side wall of the intestine or on the end of the intestine. An enlarged view of Figure 1b shows details of a preferred modification of the flange 106, in which a space or void 112 is centrally / laterally located below the flange 106. This makes the flange 106 flexible.

[0030] A preferred embodiment of the flange 106 is shown in Figure 1c. In this embodiment, the connector 100 comprises at least two parts, a body A and a flange body B. These two parts together form the flange 106 and a space or gap 112. The space or gap 112 is located below the flange 106 in a center-lateral direction between the center 101 and the first end 102. This makes the flange 106 flexible, facilitating the connection of the connector 100 and facilitating the connection of the connector 100 to devices 200, 200', 300 for placement on the side wall of the intestine or on the end of the intestine. Furthermore, as described above, the connector 100, composed of separate parts, is easy to manufacture. After the manufacture of the separate parts, the parts are assembled into the connector 100.

[0031] The number of flanges 106 may vary from one to five. Preferably, there are three flanges 106. The flanges 106 are for engaging with grooves provided on the inside of the device for placement on the side wall of the intestine or on the end of the intestine. In this way, the connector and the device for placement on the side wall of the intestine or on the end of the intestine are engaged in a locking manner.

[0032] In place of, or in addition to, at least one circumferential flange 106, the first end 102 may have at least one circumferential groove 106' extending radially inward from the first end 102. The groove 106' may be continuous or discontinuous; that is, it may be a single homogeneous groove extending radially around the tubular portion 101, or it may comprise groove segments such as notches radially arranged around the tubular portion 101. The number of grooves 106' may vary from one to five. Preferably, there is one groove 106'. The groove 106' is for engaging with a flange provided on the inside of the device for placement on the side wall of the intestine or on the end of the intestine. In this way, the connector and the device for placement on the side wall of the intestine or on the end of the intestine are engaged in a locking manner.

[0033] For simplicity, a connector 100 having a first end 102 comprising at least one circumferential flange 106 (shown in Figure 1b) is described in detail herein. However, the described features are equally relevant to a connector having a first end 102 comprising at least one circumferential groove 106' (shown in Figure 1d).

[0034] The second end 103 extends axially from the tubular portion 101 in a second direction. The second end 103 is preferably provided with means for engaging with a second device for placement on the side wall of the intestine. These means may be flanges 106 and / or pin receiving means 109. The pin receiving means 109 may optionally be a track with an internal flange, or optionally individual holes, slots, or slits with internal flanges. In the embodiments shown in Figures 5a and 5b, the connecting member comprises pin receiving means 109. Preferably, the pin receiving means 109 has a flange at its opening.

[0035] The number of pin receiving means 109 may be varied from 18 to 30.

[0036] Preferably, there are 20 to 26 pin receiving means 109, for example, 20, 22, or 24.

[0037] The connector may have a circumferential recess 108 along its outer diameter to accommodate a seal (see Figure 2a). Thus, the first end and / or second end may have at least one circumferential recess 108 on the outer surface of the first end and / or second end for accommodating a circular sealing member (see Figure 2b).

[0038] The tubular portion 101 may be provided with at least one through-hole 104 for connection to a catheter 105. The number of through-holes and the corresponding number of catheters may vary from one to five. Preferably, there are four through-holes, each connected to one catheter. The through-holes 104 and catheters 105 may be arranged symmetrically or asymmetrically along the periphery of the tubular portion 101. The catheter 105 exits the connector through a first end 102 or a second end 103.

[0039] The catheter 105 has a length that allows it to advance through the patient's anus into the intestine, thereby allowing air or water to be pushed through the catheter to confirm the sealing pressure at the anastomosis.

[0040] The connector 100 according to this disclosure may be used to connect two identical devices 200 (shown in Figure 7) or to connect two different devices 200, 300 (shown in Figure 9).

[0041] In one embodiment shown in Figure 3a, the second end 103 is provided with a circumferential flange 107 extending radially outward from the second end 103. Preferably, the flange 107 is flexible, which facilitates the connection of the connector 100 to devices 200, 300 for placement on the side wall of the intestine or on the end of the intestine. A preferred modification of the flange 107 has the same or similar shape as the modification of the flange 106 shown in the enlarged views of Figures 1b and 1c, with a space or void 112 located centrally / laterally below the flange. This makes the flange flexible. The number of flanges 107 may vary from one to five. Preferably, there are three flanges 107. The flanges 107 are for engaging with grooves provided on the inside of the devices for placement on the side wall of the intestine or on the end of the intestine. In this way, the connector and the devices for placement on the side wall of the intestine or on the end of the intestine engage in a locking manner. Such connectors are preferably used when the anastomosis is located in the small or large intestine. The second end 103 may further comprise a second circumferential recess 108 along its outer diameter for accommodating a second seal. In place of, or in addition to, at least one circumferential flange 107, the second end 103 may comprise at least one circumferential groove 107' (not shown) extending radially inward from the second end 103. The number of grooves 107' may vary from one to five. Preferably, one groove 107' is present. The groove 107' is for engaging with a flange provided on the inside of the device for placement on the side wall of the intestine or on the end of the intestine. In this way, the connector and the device for placement on the side wall of the intestine or on the end of the intestine engage in a locking manner.

[0042] For simplicity, a connector 100 having a second end 103 comprising at least one circumferential flange 107 (shown in Figure 1b) is described in detail herein. However, the described features are equally relevant to a connector having a second end 103 comprising at least one circumferential groove 107'. Figure 3b shows a connector according to one embodiment of the present disclosure. In this embodiment, the space or gap 112 is centrally / laterally located below the flanges 106, 107.

[0043] Figure 3c shows a connector according to one embodiment of the present disclosure. In this embodiment, the connector 100 comprises three components: a body A and two flange bodies B and B'. As described above, the connector 100, composed of separate components, is easy to manufacture. After the separate components are manufactured, they are assembled into the connector 100.

[0044] The connector 100 shown in Figures 3a-3c may be used to connect two identical devices 200 (see Figure 7).

[0045] The disclosure also relates to a device 200 for placement on the side wall of the intestine or on the end of the intestine. One such device 200 is shown in Figure 6a. The device 200 comprises a first member 210 and a second member 220. The first member 210 comprises an elastic portion 211 having a first axial end and a second axial end, and a rigid support portion 212 positioned at the first axial end of the elastic portion 211. The second member 220 has a first axial end and a second axial end, and the first end of the second member 220 conforms to the shape of the second axial end of the elastic portion 211 so that the intestinal wall is uniformly distributed between the second axial end of the elastic portion 211 and the second member 220. The device 200 further comprises at least one connecting member for connecting the rigid support portion 212 and the second member 220 to each other, the at least one connecting member comprising a pin receiving means 209. The pin receiving means 209 may optionally have an internal flange and may be a track or individual holes, slots or slits. The second member 220 includes at least one circumferential groove 240 located on the surface of the second member 220, which is radially inward, for locking interaction with at least one flange 106 on the connector 100 as described above. In one embodiment, the second member 220 includes two circumferential grooves 240. In place of, or in addition to, at least one circumferential groove 240, the second member 220' includes at least one circumferential flange 240' (shown in Figure 6b) located on the surface of the second member 220', which is radially inward, for locking interaction with at least one groove 106' (shown in Figure 6c) on the connector 100 as described above.

[0046] For simplicity, a device 200 comprising a second member 220 having a circumferential groove 240 is described in detail herein. However, the described features are equally relevant to a device 200 comprising a second member 220' having a circumferential flange 240' (shown in Figure 6b) that interacts with a connector 100 having at least one circumferential groove 106' (shown in Figure 1d).

[0047] Device 200 may be connected to the same device 200 or another type of device 300 (described below) via the connector 100 provided herein.

[0048] As shown in Figure 6a, the device 200 for placement on the side wall of the intestine or on the end of the intestine comprises a first member 210 and a second member 220. When placed on the side wall of the intestine or on the end of the intestine, both the first member 210 and the second member 220 are generally hollow and open structures.

[0049] The first member 210 includes an elastic portion 211 and a rigid support portion 212, as shown in Figure 6a.

[0050] The elastic portion 211 is substantially circularly symmetrical and annular, configured as a compact body or tube, and can be filled with air, gas, or fluid, and is made from, for example, an elastic polymer material with a Shore rating of 40-70. The elastic portion 211 may also be an elastic ring of a suitable polymer or rubber material, such as an elastomer. The elastic portion 211 may be biocompatible and / or biodegradable. The elastic portion 211 may have an annular cross-section. The elastic portion 211 has a first axial end and a second axial end. The cross-section of the elastic portion 211 is shown as substantially circular. However, other shapes such as rectangles, triangles, hexagons, and octagons are also possible.

[0051] The elastic portion 211 may be elastic only partially. The elasticity is used to compress a tubular structure, such as the intestine I, with a predetermined force between the elastic portion 211 and the rigid support portion 212. Other means that perform a similar function may also be used.

[0052] The elastic portion 211 may be attached to the rigid support portion 212 by adhesive bonding, or by over-moulding or co-moulding.

[0053] The rigid support portion 212 may be made of a polymer material, more specifically a biocompatible material, and most specifically a biodegradable material, that is rigid enough to stabilize the elastic portion 211. The rigid support portion 212 is positioned at the first axial end of the elastic portion 211. The rigid support portion 212 is also annular, with one side adapted to receive the elastic portion 211. This side of the rigid support portion 212 may then have an elastic portion sheet 213. The elastic portion sheet 213 may be concave to receive the convex axial end of the elastic portion 211. Thus, the outer surface of the rigid portion 212 is provided with a recess intended to receive the elastic portion 211. The recess has a shape that is at least partially complementary to the shape of the elastic portion 211. Thus, the recess may be rectangular, triangular, hexagonal, octagonal, etc.

[0054] The second member 220 is provided with means for engaging with the connector 100 according to this disclosure. These means may be circumferential grooves 240 and / or pin receiving means 209 (see Figure 6a).

[0055] Two devices 200 are connected to each other for placement on the side wall of the intestine or on the end of the intestine to form an anastomosis. The two devices 200, 200' may be connected by a connector 100 according to this disclosure (see Figure 7). Thus, the second member 220 is provided with connecting means for connection to the connector 100. The connecting means may be at least one circumferential groove 240 located on the surface of the second member 220, which is radially inward. The grooves 240 of the two devices 200, 200' interact with the circumferential flange 106 of the connector 100 in a locking manner. Alternatively or additionally, the connecting member is a pin 230 for interacting in a locking manner with a pin receiving means 109 on the connector 100. The pin 230 is preferably made of a biocompatible metallic material, but a rigid polymer is also conceivable.

[0056] In another embodiment of the connector 100 shown in Figure 4, the second end 103 of the connector 100 includes a radial projection 110 adapted to contact the intestinal wall, as shown in Figure 9. The connector 100 shown in Figure 4 may be used to connect two different devices 200, 300 (see Figure 9).

[0057] Preferably, the flange 106 is a flexible flange.

[0058] More preferably, the flange 106 is a flexible flange as shown in the enlarged view of Figure 1c, i.e., the connector 100 comprises at least two parts, a body A and a flange body B. The two parts together form the flange 106 and a space or gap 112. The space or gap 112 is located below the flange 106, in a center-lateral direction between the center 101 and the first end 102. As described above, the connector 100, composed of separate parts, is easy to manufacture. After the separate parts are manufactured, the parts are assembled into the connector 100.

[0059] The radial projection 110 may be an integral part of the second end 103 of the connector 100 (as shown in Figure 5a). Alternatively, the radial projection 110 may be a separate part attached to the second end 103 of the connector 100 (as shown in Figure 5b).

[0060] In a particular embodiment, the connector comprises three separate parts: a body A, a flange body B shown in an enlarged view in Figure 1c, and a separate part attached to the second end 103 of the connector 100 (shown in Figure 5b).

[0061] The radial projection 110 of the connector 100 is annular, and one side thereof is adapted to receive the elastic portion 311 of the device 300, as disclosed in detail below. This side of the radial projection 110 of the connector 100 may then have an elastic portion sheet 113. The elastic portion sheet 113 may be concave to receive the convex axial end of the elastic portion 311 of the device 300. Thus, the outer surface of the radial projection 110 of the connector 100 has a recess intended to receive the elastic portion 311 of the device 300. The recess has a shape that is at least partially complementary to the shape of the elastic portion 311 of the device 300. Thus, the recess may be rectangular, triangular, hexagonal, octagonal, and the like.

[0062] The connector 100 may further include a partially closed membrane 111 at a second end. This membrane provides stability when the device is positioned on the side wall of the intestine or on the end of the intestine.

[0063] Preferably, the second end 103 comprises at least one connecting member, preferably at least one connecting member comprising a pin receiving means 109. The pin receiving means 109 may optionally be a track with an internal flange, or optionally individual holes, slots, or slits with internal flanges. In the embodiments shown in Figures 5a and 5b, the connecting member comprises the pin receiving means 109. Preferably, the pin receiving means 109 comprises a flange at its opening.

[0064] The number of pin receiving means 109 may be varied from 18 to 30.

[0065] Preferably, there are between 20 and 26 pin receiving means 109, for example, 20, 22, or 24.

[0066] The connector 100 shown in Figures 4 and 5 may be used to connect two different devices 200 and 300 (see Figure 9).

[0067] Accordingly, the present disclosure also relates to a device 300 for placement on the side wall of the intestine or on the end of the intestine I (see Figures 8a, 8b and 9). The device 300 comprises a member 310, which comprises an elastic portion 311 having a first axial end and a second axial end, and a rigid support portion 312 positioned at the second axial end of the elastic portion 311. The first axial end of the elastic portion 311 conforms to the shape of the radial projection 110 of the asymmetric connector 100 according to the present disclosure so that the intestinal wall I is uniformly distributed between the first axial end of the elastic portion 311 and the radial projection 110 of the connector 100. The elastic portion 311 is substantially circularly symmetric annular, configured as a compact body or tube, and is fillable with air, gas or fluid, and is made from, for example, an elastic polymer material with a Shore of 40 to 70. The elastic portion 311 may be an elastic ring of a suitable polymer or rubber material, such as an elastomer. The elastic portion 311 may be biocompatible and / or biodegradable. The elastic portion 311 may have an annular cross-section. The elastic portion 311 has a first axial end and a second axial end. The cross-section of the elastic portion 311 is shown as substantially circular. However, other shapes such as rectangular, triangular, hexagonal, and octagonal are also possible.

[0068] The elastic portion 311 may be elastic only partially. The elasticity is used to compress a tubular structure, such as the intestinal tract I, between the elastic portion 311 and the radial projection 110 of the connector 100 with a predetermined force. Other means that perform a similar function may also be used.

[0069] The second end further comprises at least one connecting member, the at least one connecting member comprising a pin receiving means 309. The pin receiving means 309 may optionally be a track having an internal flange, or may optionally be individual holes, slots or slits having an internal flange.

[0070] The pin receiving means 109 of the connector 100 is for engaging with a pin 330 located on or positioned in a device 300 ( schematically shown in Figure 8b) for placement on the side wall of the intestine or on the end of the intestine. In this way, the connector 100 and the device 300 for placement on the side wall of the intestine or on the end of the intestine are engaged in a locking manner. Such a connector 100 is preferably used when the anastomosis is located near or inside the rectum. The pin receiving means 109 of the connector 100 may optionally be in the form of a track with an internal flange, or optionally individual holes, slots, or slits with internal flanges. The pin 330 located in the device 300 for placement on the side wall of the intestine or on the end of the intestine may be inserted into the hole or slit 109. The pins 330 on the device 300 for placement on the side wall of the intestine may be barbed, and the holes or slits 109 on the second end 103 of the connector 100 may have flanges at their openings to connect the device 300 to the connector 100 at an appropriate distance from each other. The pins 230 are preferably made of a biocompatible metal material, but hard polymers are also conceivable.

[0071] In other words, as shown in Figure 9, the connector 100 may have an integrated portion corresponding to a second member 220 of the device 200 for placement on the side wall of the intestine I or on the end of the intestine I. The second end 103 extends axially in a second direction from the tubular portion 101 of the device. In the particular embodiments shown in Figures 4 and 5, the radial projection 110 corresponds to the second member 220 of the device 200 and is adapted to contact the intestinal wall as described above.

[0072] This disclosure also relates to a device for anastomosis of tubular structures comprising the symmetric connector 100, device 200, and at least one pin 230. Preferably, the device for anastomosis of tubular structures further comprises a second device 200.

[0073] This disclosure also relates to a device for anastomosis of tubular structures comprising the asymmetric connector 100, device 200, and at least one pin 230. Preferably, the device for anastomosis of tubular structures further comprises a second device 300.

[0074] The disclosure also relates to a method for attaching a device comprising a symmetric or essentially symmetric connector 100 and two devices 200, 200' to a tubular structure having a first end and a second end to be connected, such as an intestine I. The method includes the steps of: positioning the first device 200 at the first end of the tubular structure I; connecting the connector 100 and the first device 200; positioning the second device 200' at the second end of the tubular structure I; and connecting the connector 100 and the second device 200' (as shown in Figure 7).

[0075] The disclosure also relates to a method for attaching a device comprising an asymmetric connector 100 and two different devices 200, 300 to a tubular structure having a first end and a second end to be connected, for example, an intestine I. The method includes the steps of: positioning the first device 200 at the first end of the tubular structure I; connecting the asymmetric connector 100 and the first device 200; positioning the second device 300 at the second end of the tubular structure I; and connecting the connector 100 and the second device 300 (as shown in Figure 9).

[0076] In both methods, the catheter can enter the lumen of the tubular structure via the second device 200, 300.

[0077] In both methods, the pressure is preferably distributed essentially uniformly on the walls of the tubular structure between the elastic portion 211 and the second member 220, and / or between the elastic portion 311 and the radial projection 110 of the connector 100.

[0078] During the resection of a tumor from the intestine, the affected portion of the intestine is resected by cutting the intestine at an appropriate distance on each side of the intestine. Depending on the location and condition of the tumor, it may be necessary to connect one side of the free end of the intestine to the other side of the free end of the intestine, or to connect one side of one free end to the other free end. The connectors and devices for anastomosis of tubular structures according to the present disclosure enable the formation of such connections via one side of free ends, or connections between two free ends.

[0079] When connecting the side of the free end of intestine I, the open end is first closed by suturing. Next, intestine I is incised at the appropriate position. Then, the first member 210 of the device 200 for placement on the side wall of intestine I is inserted through the incision and positioned in the lumen of intestine I, so that its second axial end contacts the inner wall of intestine I, and the first member 210 is further positioned around the incision formed while incising the wall of the tubular structure I. After positioning the first member 210 inside intestine I, the size of the incision can be reduced by suturing to facilitate the positioning of the first member 210 around the incision. Alternatively, when connecting the open end of intestine I, the first member 210 of the device 200 for placement on the side wall of intestine I is inserted into the open intestine, so that its second axial end contacts the inner wall of intestine I. Then, the size of the open end can be reduced by suturing to facilitate the positioning of the first member 210.

[0080] After the first member 210 is positioned within the lumen of the intestine I, the second member 220 is positioned outside the intestine I accordingly. The second member 220 has a first axial end and a second axial end. The first end of the second member 220 conforms to the shape of the second axial end of the elastic portion 211 so that the wall of the intestine I may be uniformly distributed between the second axial end of the elastic portion 211 and the second member 220. A connecting member 230 is provided to connect the first member 210 to the second member 220. Preferably, the connecting member is a pin 230, which is inserted into a hole 209, track, slit or slot located in the rigid support 212. Thus, the second member 220 can be connected to the first member 210 by inserting the pin 230 into a hole 209, track, slot or slot located in the rigid support 212. The pin 230 may have a barb, and the holes 209, tracks, slots, or slits on the rigid support portion 212 on the first member 210 may have flanges at their openings to connect the first member 210 to the second member 220 at an appropriate distance from each other, at which point the intestine I is compressed between the elastic portion 211 of the first member 210 and the second member 220.

[0081] The second member 220 is preferably made from a polymer material, more specifically from a biocompatible material, and most specifically from a biodegradable material. The pin 230 is preferably made from a biocompatible metal material, but a hard polymer is also conceivable. The portion of the second member 220 that interacts with the intestine has a concave intestine / elastic sheet 213 at its first axial end, intended to face the intestine I and the first member 210, so that the circular elastic portion 211 that forms contact with the intestine I is placed on the second member 220 in a simple manner (see Figure 7).

[0082] As the first member 210 and the second member 220 are brought close together, the pins 230 penetrate the wall of the intestine I around the incision, and then they enter holes 209, tracks, slots, or slits on the rigid support portion 212 of the first member 210. Then, if present, the barbs and flanges interact to connect the first member 210 to the second member 220. In this way, the first member 210 and the second member 220 are connected to each other radially inward of the elastic portion 211, and the intestinal wall I is compressed with uniform pressure between the elastic portion 211 of the first member 210 and the concave intestine / elastic portion sheet 213.

[0083] Subsequently, the excess intestinal tissue around the incision within the edges of the first member 210 and the second member 220 may be excised along the inner edges of the first member 210 and the second member 220.

[0084] The connector 100 is attached to a device 200 for placement on the side wall of the intestine I or on the end of the intestine I. A second member 220 of the device 200 has at least one circumferential groove 240 which interacts in a locking manner with the flange 106 of the first end 102 of the connector 100.

[0085] When a symmetrical or essentially symmetrical connector is used, a second device 200' for placement on the side wall of the intestine or on the end of the intestine is placed on the second end of the intestine I as described above. The second device 200' is then attached to the second end 103 of the connector 100, thereby connecting both ends of the intestine. In this embodiment, the second end 103 of the connector 100 comprises at least one flange 107, which locks into at least one groove 240 located inside the second member 220 of the second device 200' (see Figure 7).

[0086] When an asymmetrical connector 100 is used, a second device 300 for placement on the side wall of the intestine or on the end of the intestine is placed on the second end of the intestine. The second end of the intestine is closed by suturing, and the second device 300 is introduced into the lumen of the intestine I by insertion through the anus. Alternatively, the second device 300 is introduced into the lumen of the intestine I, and then the second end of the intestine is closed. Before attaching the connector 100 to the device 300, the intestinal wall is positioned to cover the second device 300. Thus, after the second device 300 is placed in the lumen of the intestine I, the connector 100 is positioned outside the intestine I accordingly, so that the radial projection 110 of the connector 100 fits with the elastic portion 311 of the member 310 of the device 300. The intestinal wall is located between the radial projection 110 of the connector 100 and the elastic portion 311 of the member 310 of the device 300. The intestinal wall is distributed essentially uniformly between the elastic portion 311 and the radial projection 110 of the connector 100. The portion of the radial projection 110 of the connector 100 facing the intestinal wall, i.e., the portion of the connector 100 that interacts with the intestine, has a concave intestine / elastic portion sheet 113, intended to face the intestine I and the first member 310, thereby allowing the circular portion of the elastic portion 311 that forms the intestine in contact with them to rest on the connector 100 in a simple manner. A connecting member is provided to connect member 310 to connector 100. Preferably, the connecting member is a pin 330. When the device 300 and connector 100 are brought close together, the pins 330 penetrate the intestinal wall and then enter holes 109, tracks, slits, or slots on the connector 100. Therefore, the connector 100 can be connected to member 310 by inserting the pin 330 into a hole 309, track, slot or slit located in the rigid support 312, and then into a hole 109, track, slot or slit in the connector 100. Then, if present, the barb and flange (similar to those described above) interact to connect member 310 to connector 100. In this way, member 310 and connector 100 are connected to each other radially inward of the elastic portion 311, and the intestinal wall is compressed with uniform pressure between the elastic portion 311 of member 310 and the concave intestinal / elastic portion sheet 113 of the radial projection 110 of connector 100.Subsequently, excess intestinal tissue around the incision within the edges of member 310 and connector 100 may be excised along the inner edges of member 310 and connector 100.

[0087] After both ends of the intestine have healed, the device is removed from the body.

Claims

1. A connector (100) for connecting two anastomosis devices, Having a generally hollow, open structure, the connector (100) has a tubular portion (101) that is centrally located on its axis, A first end (102) extending axially in a first direction from the tubular portion (101), wherein the first end (102) comprises at least one continuous or discontinuous circumferential flange (106) extending radially outward from the first end (102), and / or at least one continuous or discontinuous circumferential groove (106') extending radially inward from the first end (102), A second end (103) extending axially in a second direction from the tubular portion (101) and A connector (100) is provided.

2. The connector according to claim 1, wherein the first end and / or second end is provided with at least one circumferential recess (108) on the outer surface of the first end and / or second end for accommodating a circular sealing member.

3. The connector according to claim 1 or 2, wherein the tubular portion (101) comprises at least one through-hole (104) for connecting to a catheter (105).

4. The connector according to claim 3, wherein the catheter exits the connector through the first end or the second end.

5. The connector according to any one of claims 1 to 4, wherein the second end comprises a circumferential flange (107) extending radially outward from the second end (103), and / or at least one circumferential groove extending radially inward from the second end (103).

6. The connector according to any one of claims 1 to 4, wherein the second end comprises a radial projection (110) adapted to contact the intestinal wall.

7. The connector according to claim 6, wherein the second end further comprises at least one connecting member, preferably the at least one connecting member comprising a pin receiving means (109).

8. The connector according to claim 7, wherein the pin receiving means (109) is provided with a flange at its opening.

9. The connector according to any one of claims 6 to 8, further comprising a partially closed membrane (111) at the second end.

10. A device (200) for placement on the lateral wall of the intestine or on the end of the intestine, A first member (210) comprising an elastic portion (211) having a first axial end and a second axial end, and a rigid support portion (212) disposed at the first axial end of the elastic portion (211), The elastic portion (211) has a first axial end and a second axial end, and between the second axial end of the elastic portion (211) and the second member (220, 220'), the first end of the second member (220, 220') is shaped to conform to the shape of the second axial end of the elastic portion (211), so that the intestinal wall can be uniformly distributed. At least one connecting member for connecting the rigid support portion (212) and the second members (220, 220') to each other, wherein the at least one connecting member comprises a pin receiving means (209), Equipped with, Device (200) wherein the second member (220, 220') comprises at least one continuous or discontinuous circumferential groove (240) located on the inner surface of the radially inward-facing second member (220), and / or at least one groove (240') located on the inner surface of the radially outward-facing second member (220'), for locking interaction with at least one flange on a connector according to any one of claims 1 to 9.

11. A device for anastomosis of tubular structures, comprising a connector according to any one of claims 1 to 5, a device according to claim 10, and at least one pin (230).

12. A device (300) for placement on the lateral wall of the intestine or on the end of the intestine, The member (310) is provided, The member (310) comprises an elastic portion (311) having a first axial end and a second axial end, and a rigid support portion (312) disposed at the second axial end of the elastic portion (311), The first axial end of the elastic portion (311) conforms to the shape of the radial projection of the connector according to any one of claims 6 to 9, so that the intestinal wall is uniformly distributed between the first axial end of the elastic portion (311) and the radial projection of the connector. The device (300) further comprises at least one connecting member at the second end, the at least one connecting member comprising a pin receiving means (309).

13. A device for anastomosis of tubular structures, comprising a connector according to any one of claims 6 to 9, a device according to claim 10, and at least one pin (230).

14. A method for attaching the device according to claim 11 or 13 to a tubular structure having a first end and a second end to be connected, - A step of placing a first device (200) at the first end of the tubular structure, wherein the first device (200) is the device (200) described in claim 10, - A step of connecting the connector (100) and the first device (200) according to any one of claims 1 to 9, - A step of arranging a second device (200, 300) at the second end of the tubular structure, wherein the second device (200) is the device described in claim 10 or claim 12, - The steps of connecting the connector (100) and the second devices (200, 300) and Methods that include...

15. The method according to claim 14, wherein the catheter enters the lumen of the tubular structure via the second device (200, 300).

16. The method according to claim 15, wherein the pressure is distributed essentially uniformly on the wall of the tubular structure between the elastic portion (211) and the second member (220) and / or between the elastic portion (311) and the radial projection (110) of the connector (100).

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