Negative pressure anastomosis system

Abstract

A system for anastomosis of a tubular structure, the system comprising: a device configured such that, when the device is placed within the tubular structure, an anastomosis is obtained within the tubular structure and a cavity is formed between the device and the tubular structure; and a pump in fluid communication with the cavity and configured to temporarily apply negative pressure to the cavity.

Description

[Technical Field]

[0001] TECHNICAL FIELD The present disclosure relates to anastomosis of biological tissue, and more particularly to a system for anastomosis of tubular structures. [Background technology]

[0002] Colorectal cancer is the third most common type of cancer in the world, with approximately 1 million new cases occurring each year. Cancer cases are significantly more common in industrialized regions of the world.

[0003] During tumor removal from living tissue, for example, a tubular structure such as the intestine, the affected portion of the tissue is removed by cutting the tissue at an appropriate distance on each side. Depending on where and how the tumor was located, it may be necessary to reconnect the tissue. In the case of tubular structures, this process is known as anastomosis.

[0004] A major challenge in anastomotic healing is the blood circulation of the anastomosis during the healing process. Despite substantial advances in surgical techniques over the past few decades, morbidity and mortality after resection in the gastrointestinal tract, for example due to anastomotic leakage, remain a serious problem. Another problem resulting from anastomotic stapling is anastomotic stricture. The critical area for healing, i.e., the contact area between the two ends of the hollow structures being joined, must be liquid-proof, and the cross-section of the lumen should be the same size and flexibility as the original lumen.

[0005] Therefore, there is a need in the art to develop an assembly that overcomes these shortcomings. One such assembly is disclosed in International Publication No. 2007 / 122223, which discloses a device including a mating member for use in achieving an anastomosis of tubular organs. The device includes two rigid parts in which two elastic rings are disposed. Two intestinal ends are respectively secured between each rigid part and a corresponding elastic part, and the rigid parts are then interconnected by a connecting member. Another such assembly is disclosed in International Publication No. 2014 / 031065, which discloses a similar device for use in the side wall of the intestine. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2007 / 122223 [Patent Document 2] International Publication No. 2014 / 031065 Summary of the Invention [Problem to be solved by the invention]

[0007] However, it is difficult to control and monitor the healing process with such devices because they are placed in the intestine until they are naturally expelled from the body, sometimes after surgery. [Means for solving the problem]

[0008] Accordingly, the present disclosure preferably seeks to mitigate, alleviate, or eliminate, singly or in any combination, one or more of the above-identified deficiencies and drawbacks in the art. This is accomplished by a system including a pump in fluid communication with a cavity formed between an anastomosis device and a tubular structure. The system can be used to control and monitor the healing process of an anastomosis formed by the device.

[0009] According to one aspect, a system for anastomosis of a tubular structure is provided, the system including a device configured to obtain an anastomosis in the tubular structure and form a cavity between the device and the tubular structure when the device is placed within the tubular structure, and a pump in fluid communication with the cavity and configured to temporarily apply negative pressure to the cavity.

[0010] Optionally, the pump is configured to periodically apply negative pressure to the cavity. Optionally, the time period during which the pump is configured to apply negative pressure to the cavity is inversely proportional to the heart rate of the patient having the tubular structure. Optionally, the time period during which the pump is configured to apply negative pressure to the cavity is an integer multiple of the time between successive heartbeats of the patient having the tubular structure. Optionally, the magnitude of the negative pressure is less than the magnitude of the diastolic blood pressure of the patient having the tubular structure. Optionally, the pump is a vacuum pump.

[0011] Optionally, the system further includes at least one catheter in fluid communication with the cavity at a first end and in fluid communication with the pump at a second end. Optionally, during use, the second end of the at least one catheter is configured to pass through the tubular structure and exit through the rectum of a patient having the tubular structure. Optionally, the at least one catheter includes at least two catheters. Optionally, a first catheter of the at least two catheters is configured as an inlet to the cavity for contrast agent, and a second catheter of the at least two catheters is configured as an outlet from the cavity for contrast agent. Optionally, the at least two catheters include four catheters.

[0012] Optionally, the system further includes a pressure sensor configured to measure pressure within the cavity. Optionally, the pressure sensor is integrated with the pump. Optionally, the system further includes an absorbent element disposed between the pump and the cavity.

[0013] Optionally, the tubular structure includes a first portion and a second portion, and the device is configured such that when the device is placed within the tubular structure, an anastomosis is obtained at a contact area between the first portion of the tubular structure and the second portion of the tubular structure, and a cavity is formed between the device, the first portion of the tubular structure, and the second portion of the tubular structure.

[0014] Optionally, the device includes a first member and a second member having a generally hollow, open structure such that, when the device is placed within the tubular structure, an anastomosis is achieved at the contact area between the first member and the second member and a cavity is formed between the first member and the second member and the tubular structure. Optionally, the first member and / or the second member are provided with at least one hole arranged to allow fluid communication between the pump and the cavity. Optionally, the first member and the second member each include a rigid member and an elastic member arranged such that the contact area is between the elastic members and a cavity is formed between the rigid member and the tubular structure. Optionally, the elastic member is ring-shaped. Optionally, the elastic member is made of a polymeric material such as an elastomer. Optionally, the elastic member is made of a biocompatible and / or biodegradable material. Optionally, each elastic member and the corresponding rigid member form a continuous contact line that induces necrosis within the tubular structure during use. Optionally, the rigid components are configured to connect to one another such that a distance is formed between the resilient components.

[0015] According to another aspect, a method for anastomosis of a tubular structure is provided, the method including the steps of positioning a device within the tubular structure such that an anastomosis is achieved within the tubular structure and a cavity is formed between the device and the tubular structure, and temporarily applying negative pressure to the cavity using a pump in fluid communication with the cavity.

[0016] Optionally, the method includes periodically applying negative pressure to the cavity. Optionally, a period of time during which the pump is configured to apply negative pressure to the cavity is inversely proportional to a heart rate of the patient having the tubular structure. Optionally, a period of time during which the pump is configured to apply negative pressure to the cavity is an integer multiple of the time between successive heartbeats of the patient having the tubular structure. Optionally, the method includes applying negative pressure at a level lower than a level of diastolic blood pressure of the patient having the tubular structure. Optionally, the pump is a vacuum pump.

[0017] Optionally, the method further includes positioning at least one catheter between the pump and the cavity such that a first end of the catheter is in fluid communication with the cavity and a second end of the catheter is in fluid communication with the pump. Optionally, the method includes positioning the at least one catheter such that a second end of the at least one catheter passes through the tubular structure and exits through a rectum of a patient having the tubular structure. Optionally, the at least one catheter includes at least two catheters. Optionally, the method includes supplying contrast agent to the cavity with a first catheter of the at least two catheters and removing the contrast agent from the cavity with a second catheter of the at least two catheters. Optionally, the at least two catheters include four catheters.

[0018] Optionally, the method further comprises measuring the pressure in the cavity. Optionally, the method further comprises measuring the pressure in the cavity using a pressure sensor integrated with the pump. Optionally, the method further comprises disposing an absorbent element between the pump and the cavity.

[0019] Further objects, features, and advantages of the present disclosure will emerge from the following detailed description, from the accompanying drawings, and from the dependent claims.

[0020] Exemplary embodiments of the present disclosure will now be described with reference to the drawings. [Brief explanation of the drawings]

[0021] [Figure 1] 1 is a schematic diagram of a system for anastomosis of biological tissue, according to one embodiment. [Figure 2a] FIG. 1 is a perspective exploded view of an anastomosis device according to one embodiment. [Figure 2b] 2b is a perspective view of a member of the anastomosis device of FIG. 2a according to one embodiment. [Figure 3a] 1 is a cross-sectional view of an anastomosis device positioned within a tubular structure. [Figure 3b]FIG. 3b is an enlarged view of the cross section of FIG. 3a. [Figure 4] FIG. 10 is a diagram of exemplary measurements from pressure sensors in the system. DETAILED DESCRIPTION OF THE INVENTION

[0022] Like reference numbers refer to like parts throughout the description and drawings.

[0023] FIG. 1 schematically illustrates a system 100 for anastomosis of biological tissue, particularly tubular structures. The system 100 includes an anastomosis device 102 and a pump 104. During use, the device 102 is placed within a tubular structure 106, such as an intestine. As discussed below, once the device 102 is placed within the tubular structure 106, a cavity is formed between the device 102 and the tubular structure 106. The pump 104 is in fluid communication with the cavity, for example, via one or more catheters 108. The pump 104 is configured to apply negative pressure to the cavity. In some embodiments, an absorbent element 110 is disposed between the pump 104 and the device 102 or the cavity. While the system 100 may typically be used for anastomosis of the intestine, it should be understood that the system may also be implemented within other tubular structures of the body for anastomosis of those structures.

[0024] To further explain the operation of system 100, an example of device 102 will be described in more detail. Device 102 may be an anastomosis device such as those disclosed in WO2007122223 and / or WO2014 / 031065, although it is contemplated that any anastomosis device configured to obtain an anastomosis in a tubular structure and in which a cavity is formed between the device and the tubular structure when the device is placed within the tubular structure may be used.

[0025] An exploded view of an exemplary device 102 is shown in FIG. 2a. The device 102 includes a first member 202a and a second member 202b that are connectable to each other. The first member 202a may include a first rigid component 204a and a first resilient component 206a. The second member 202b may include a second rigid component 204b and a second resilient component 206b. The first member 202a and the second member 202b, specifically the rigid components 204a, 204b and the resilient components 206a, 206b, may have a generally hollow, open structure.

[0026] The rigid elements 204a, 204b are ring-shaped with sides or recesses adapted to receive corresponding resilient elements 206a, 206b. The recesses have a shape that at least partially complements the shape of the resilient elements 206a, 206b. The rigid elements 204a, 204b may be formed of a polymeric material, more particularly a biocompatible material, most particularly a biodegradable material, that is sufficiently rigid to stabilize the resilient elements 206a, 206b.

[0027] The elastic elements 206a, 206b are also ring-shaped. They may be fabricated as small bodies or tubes filled with air, gas, or fluid. They may be fabricated from a polymeric or rubber material, such as an elastomer, with a hardness of, for example, 40 to 70 Shore. In some embodiments, the elastic elements 206a, 206b are fabricated from a biocompatible and / or biodegradable material. The elastic elements 206a, 206b may be only partially elastic. The elasticity is used to compress the tubular structure 106 with a certain force between the elastic element 206a and the rigid element 204a, and between the elastic element 206b and the rigid element 204b, respectively, as described below. Other means for performing the same function are also contemplated. As shown in Figures 3a-3b, the elastic elements 206a, 206b have a circular cross section, but may be any other shape, such as oval or elliptical, or partially rectangular, triangular, hexagonal, octagonal, etc., and may be segmented.

[0028] To form the first and second members 202a and 202b, the resilient elements 206a and 206b are positioned within the recesses of the rigid elements 204a and 204b, respectively. The resilient elements 206a and 206b therefore have inner diameters smaller than the smallest outer diameters of the rigid elements 204a and 204b. The resilient elements 206a and 206b may be attached to the rigid elements 204a and 204b by adhesive, overmolding, or co-molding. As shown in FIGS. 3a and 3b, the hollow open structures of the first and second members 202a and 202b have circular cross-sections, but they may be any other shape, such as elliptical or oval, or partially rectangular, triangular, hexagonal, octagonal, or segmented.

[0029] To assemble the device 102, the rigid components 204a, 204b of the first and second members 202a, 202b are configured to connect to one another such that a distance is formed between their respective resilient components 206a, 206b. The device 102 may additionally include a connecting member 208 for coupling the first member 202a to the second member 202b. In one embodiment, the connecting member 208 is integral with the first rigid component 204a, although it should be understood that the connecting member 208 could be integral with the second rigid component 204b or could be a separate element. The first and second members 202a, 202b may be connectable to one another as male-female components using the connecting member 208.

[0030] FIG. 2b illustrates the first member 202a provided with four catheters 108. The catheters 108 may be attached to respective holes in the first rigid part 204a. As described in connection with FIGS. 3a-3b, the holes may allow the catheters 108 to be in fluid communication with the cavity formed between the device 102 and the tubular structure 106. Although four catheters 108 are shown in FIG. 2b, any suitable number of catheters 108 may be implemented. In some embodiments, a single catheter 108 may be used. In other implementations, multiple catheters 108 may be used, such as two, four, or any other suitable number. When multiple catheters 108 are implemented, the holes may be symmetrically disposed around the annular wall of the first rigid part 204a.

[0031] The device can be positioned to connect the two free ends of the tubular structure 106 or can be positioned on the sidewall of the tubular structure 106. When connecting the free ends of the tubular structure 106, the first member 202a is positioned within the lumen of the tubular structure 106 so that it is in contact with the inner wall of the tubular structure 106 and is positioned around the incision made during the incision in the wall of the tubular structure 106. After placing the first member 202a within the tubular structure 106, the intestinal end is secured between each rigid member 204a and the corresponding elastic member 206a. After placing the first member 202a within the lumen of the tubular structure 106, the second member 202b is correspondingly positioned at the other free end of the tubular structure 106. The first member 202a and the second member 202b can then be connected, for example, using a connecting member 208. For example, the first member 202a and the second member 202b may be snap-fit ​​together to cooperate.

[0032] 3a shows a cross-sectional view of a device 102 disposed within a tubular structure 106. The tubular structure 106 has a first end 302 and a second end 304 that are fused together. In the illustrated example, the device 102 has a first rigid part 204a provided with several catheters 108. A first elastic part 206a is disposed inside the tubular structure 106 at the first end 302, and the edge of the first end 302 is folded over the first elastic part 206a. The first rigid part 204a is inserted into the tubular structure 106 from the first end 302, expanding the first elastic part 206a so that it is surrounded or wrapped on three sides by the tubular structure 106 until it snaps around the circumference of the first rigid part 204a. The first elastic element 206a is then locked to the first rigid element 204a within the recess of the first rigid element 204a. Thus, a single layer of the tubular structure 106 is crushed between the first rigid element 204a and the first elastic element 206a. The described operations are repeated to position the second element 202b within the second end 304 of the tubular structure 106. Thus, the first and second ends 302, 304 of the tubular structure 106 are secured within the first and second elements 202a, 202b, respectively, of the device 102. The final operation to install the device 102 is to connect the first and second elements 202a, 202b using the connecting element 208, which can be performed by a simple pressing action by the operator's hand.

[0033] Figure 3b shows an enlarged view of cross section A of Figure 3a. The enlarged view shows the compression of tubular structure 106 between rigid components 204a, 204b and resilient components 206a, 206b. The tip of first end 302 is folded and positioned between first rigid component 204a and first resilient component 206a to form a first lip or contact surface 306 that is essentially circular. Similarly, second end 304 forms a second lip or contact surface 308. Essentially uniform and equal pressure is exerted on contact surfaces 306, 308 around the entire circumference.

[0034] When the device 102 is placed within the tubular structure 106, a contact area 310 is created between the contact surfaces 306, 308. The contact area is formed between the first member 202a and the second member 202b, specifically between the elastic elements 206a, 206b. At the contact area 310, an anastomosis is obtained; that is, at the contact area 310, tissue regeneration occurs, resulting in the fusion of the two ends 302, 304 of the tubular structure 106.

[0035] Pressure from the corresponding elastic components 206a, 206b forms a point of necrosis 312 (shown only on the second end 304) at the point where the tubular structure 106 is pressed against the rigid components 204a, 204b. Blood flow or circulation at the ends 302, 304 of the tubular structure 106 is blocked (restricted) and ceases until the point of necrosis 312 is reached. The point of necrosis 312 extends around the ends 302, 304 of the tubular structure 106 such that it can also be considered a line of necrosis 312. Once the two ends of the tubular structure 106 are fused, i.e., healed, the tissue separates at the line of necrosis 312, and the device 102 is automatically released from the tubular structure 106. The device 102 can then leave the tubular structure 106, for example, to follow the flow of feces through the intestines. This may occur at different times for different patients, but typically will occur between one and three weeks post-operatively, for example, about days 10 to 12. In some cases, device 102 may leave tubular structure 106 through the stoma opening.

[0036] The first member 202a and the second member 202b are specifically dimensioned so that when the members 202a, 202b are interlocked without the two ends 302, 304 of the tubular structure 106 being disposed therebetween, a gap exists between the first resilient elements 206a, 206b. As shown in FIG. 3b, when the device 102 is disposed within the tubular structure 106, the ends 302, 304 of the tubular structure expand to form a closed cavity 314 defined by the compressed tubular structure 106 and the device 102. Specifically, the cavity is formed between the rigid elements 204a, 204b of the first member 202a and the second member 202b and the two ends 302, 304 of the tubular structure 106.

[0037] A first end of the catheter 108 is disposed within a bore in the rigid component 204a. The first end of the catheter 108 opens into the cavity 314 and is therefore in fluid communication with the cavity 314. The catheter 108 extends from the device 102 through and out of the tubular structure 106, for example, through the rectum. The second end of the catheter 108 can thus be placed in fluid communication with a device outside the body, such as a pump 104, syringe, or other device used to manage or control the healing of the ends 302, 304 of the tubular structure 106. Additionally, various fluids can be supplied to the cavity 314 in continuous or intermittent flow. As described below, the fluid could be a growth stimulant or a contrast agent.

[0038] Thus, the pump 104 may be placed in fluid communication with the cavity 314 by the catheter 108. The pressure within the cavity 314 has an equilibrium value, i.e., the undisturbed pressure within the cavity 314. This may be atmospheric pressure. The pump 104 may be used to apply a negative pressure to the cavity 314, for example, by drawing fluid from the cavity 314. The pump 104 may be a suction pump or a vacuum pump. The negative pressure applied by the pump 104 is measured against the equilibrium value. The pump 104 may be configured to temporarily apply a negative pressure to the cavity 314. Thus, the pressure within the cavity 314 may be reduced by the pump 104 to a predetermined level, at which point the pump 104 is stopped (or a valve is closed) and the pressure within the cavity 314 is restored to its equilibrium value. Thus, the pressure within the cavity 314 decreases and then increases. This aids the healing process in the contact area 310, as healing is stimulated by tissue mobility due to pressure changes. Because negative pressure is applied for only short periods of time, it also ensures a regular supply of blood to the healing area of ​​the tubular structure 106.

[0039] The pump 104 may be configured to periodically apply negative pressure to the cavity 314. Thus, the pressure within the cavity 314 periodically decreases and increases, thereby further stimulating tissue mobility. The time period may be set based on the heart rate of the patient having the tubular structure 106. Specifically, as the patient's heart rate increases, the time period for which negative pressure is applied may decrease. That is, the time period is inversely proportional to the heart rate. In some embodiments, the time period is an integer multiple of the time between successive heartbeats of the patient. In some embodiments, the pump 104 may be configured to repeatedly apply negative pressure to the cavity 314 at non-regular intervals, e.g., irregularly.

[0040] The level of negative pressure applied by the pump 104 may depend on the patient's blood pressure, specifically the diastolic pressure within the tubular structure 106. If the level of negative pressure applied by the pump 104 is higher than the diastolic pressure within the tubular structure 106, only the structure of the walls of the tubular structure 106 will keep it open. If the tubular structure 106 collapses, blood flow to the healing area will be reduced, leading to a failure of the healing process. To avoid this situation, the level of negative pressure applied by the pump 104 must be lower than the level of diastolic pressure within the tubular structure 106. A typical level of negative pressure applied by the pump 104 may be between -40 mbar and -80 mbar, but may vary from patient to patient.

[0041] The pumping regime described above can be applied for a time sufficient to successfully initiate the healing process. For example, the pumping regime can be applied for up to 48 hours post-operatively, which corresponds to the critical healing period for such surgery. In some embodiments, the pumping regime can be applied for more or less than 48 hours.

[0042] The pumping regime may be controlled externally, for example, by varying the time duration or level of negative pressure applied by pump 104. In some embodiments, the pumping regime may be controlled by a computer or mobile application, as described below.

[0043] Only a single catheter 108 is required for the pump 104 to apply negative pressure to the cavity 314. The single catheter 108 provides fluid communication between the pump 104 and the cavity 314 so that the pump 104 can control the pressure within the cavity 314. In some embodiments, multiple catheters 108 are implemented between the pump 104 and the cavity 314. In one embodiment, four catheters 108 are implemented between the pump 104 and the cavity 314, such as that shown in FIG. 2b.

[0044] In some embodiments, the absorbent element 110 is disposed between the pump 104 and the cavity 314, for example, at a point along the length of the catheter 108. This ensures that any liquid or contaminants, such as blood or pus, that are extracted from the cavity 314 during operation of the pump 104 do not enter the pump 104 and contaminate or interfere with the operation of the pump.

[0045] To monitor the healing process, a pressure sensor can be implemented to measure the pressure within the cavity. The pressure sensor may be integrated with the pump 104 or, in some embodiments, may be incorporated into the device 102. FIG. 4 shows an example measurement 400 from a pressure sensor. The measurement 400 shows the pressure relative to an equilibrium pressure value within the cavity 314 over time. The equilibrium pressure value within the cavity 314 is therefore shown as a zero value. In this configuration, the pump 104 enforces a pressure of −50 mbar within the cavity once every 20 seconds. After the pressure is reduced by the pump 104 in a first phase 402, there is a recovery phase 404 in which the pressure returns to its equilibrium value. As described above, this process is repeated periodically.

[0046] The pressure sensors provide real-time feedback regarding the healing of the anastomosis. In this manner, it is possible to continuously monitor the healing process of the two ends 302, 304 of the tubular structure 106. For example, if the pressure reaches an equilibrium level as expected during the recovery phase 404, it can be assumed that the healing process is progressing as planned. However, any variation from the expected measurement may indicate a problem with the healing process. For example, if the pressure does not decrease to the expected level or takes longer than expected to achieve that level, this may indicate a hole in the tubular structure 106 adjacent to the healing area. FIG. 4 also shows a measurement 406 in which a temporary hole is formed in the tubular structure 106 but closes the next time negative pressure is applied by the pump 104.

[0047] The measurements 400 may be provided on a display, such as a display on the pump 104 or a separate display, such as a computer display, for review by an operator, such as a doctor or nurse. In some embodiments, the measurements 400 or related data may be transmitted to a remote location for review by the operator. It is also contemplated that the measurements 400 information may be transmitted to a computer or mobile application for review by the operator. The application may also be used to control the pumping regime, for example, by modifying the time period or level at which negative pressure is applied by the pump 104. Such modifications may be based on the patient's baseline condition, such as their age and stability, and monitored values ​​provided by a pressure sensor, to ensure that the optimal time period and / or pressure level is applied to that particular patient.

[0048] In some implementations, the system 100 may also be used to visualize the anastomosis during surgery and / or healing. To accomplish this, contrast media may be delivered through the catheter 108 to perform radiological control of the anastomosis, for example, with respect to access or contrary leakage, which is of particular importance immediately after attachment of the device 102 to the tubular structure 106.

[0049] To enable this, the first catheter 108 may be configured as an inlet for the contrast agent, and the second catheter 108 may be configured as an outlet for the contrast agent. As the contrast agent is delivered to and from the cavity 314, a scan may be taken to visualize the presence of the contrast agent within the cavity 314. For example, an X-ray scan may be taken to show the contrast agent relative to the tubular structure 106. This may indicate whether a leak is present at the anastomosis. In another implementation, a constant pressure of contrast agent may be applied to one catheter 108, while the other catheter 108 is kept closed. This allows for measurement of the pressure within the cavity 314 to detect any leaks. The absorbent element 110 may again be used to prevent any contrast agent from entering the pump 104 and contaminating it or interfering with its operation.

[0050] The system 100 disclosed above can be used to control and monitor the healing process of an anastomosis formed in a tubular structure by an anastomosis device. The pump 104 can periodically apply negative pressure to the cavity 314, which aids in the healing process. The negative pressure can be set to an appropriate value to prevent collapse of the tubular structure 106 during healing. This pumping regime can be applied for up to 48 hours postoperatively, which corresponds to the critical healing period. The pumping regime can be controlled externally, for example, by a computer or mobile application. An absorbent element can be implemented between the pump 104 and the cavity 314 to prevent any liquid or contaminants extracted from the cavity 314 from entering the pump 104 and contaminating it or interfering with its operation. A pressure sensor can be used to provide real-time feedback on the healing of the anastomosis. The system 100 may also be used to visualize the anastomosis during surgery and / or healing, for example, using contrast agents, to detect any leakage from the anastomosis.

[0051] In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements, or method steps may be performed. Furthermore, although individual features may be included in various embodiments, these may be combined in other ways, and the inclusion in various embodiments does not imply that a combination of features is not feasible. Furthermore, singular reference does not exclude a plurality. The terms "a" and "an" do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way. [Explanation of symbols]

[0052] 100 Anastomosis Systems 102 Anastomosis Device 104 Pump 106 Tubular structure 108 catheter, first catheter, second catheter 110 Absorption Factor 202a first member (of an anastomosis device) 202b second member (of anastomosis device) 204a (of the first member) first rigid part 204b (of the second member) second rigid part 206a (of the first member) first elastic part 206b (of the second member) second elastic part 208 (anastomosis device) connecting member 302 (of the tubular structure) first end 304 (of the tubular structure) second end 306 First lip portion, contact surface 308 Second lip, contact surface 310 Contact area 312 Necrosis 314 Cavity 400, 406 measurements 402 First Stage 404 Recovery Phase Section A

Claims

1. 1. A system for anastomosis of tubular structures, comprising: a device (102) comprising a first member (202a) and a second member (202b) connectable to each other, the first member (202a) comprising a first rigid member (204a) and a first elastic member (206a), and the second member (202b) comprising a second rigid member (204b) and a second elastic member (206b), the device (102) being configured such that, when the device (102) is placed within the tubular structure, an anastomosis is obtained within the tubular structure and a cavity is formed between the device (102), the first portion of the tubular structure, and the second portion of the tubular structure; a pump (104) in fluid communication with the cavity and configured to periodically and temporarily apply negative pressure to the cavity; Including, the system.

2. 10. The system of claim 1, further comprising at least one catheter in fluid communication at a first end with the cavity, such that when the device is positioned within the tubular structure, an anastomosis is achieved within the tubular structure and a cavity is formed between the device and the tubular structure, and in fluid communication with the pump at a second end.

3. The system of claim 2 , wherein the at least one catheter comprises at least two catheters.

4. The system of claim 1 , further comprising a pressure sensor configured to measure a pressure within the cavity.

5. the tubular structure includes a first portion and a second portion, and the device, when positioned within the tubular structure, the anastomosis is obtained at a contact area between the first portion of the tubular structure and the second portion of the tubular structure; The cavity is formed between the device, the first portion of the tubular structure, and the second portion of the tubular structure.

5. The system according to claim 1, wherein the system is configured to:

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