Implantable anastomosis device

Abstract

Implantable anastomosis device (2) for use in a surgical connection between two hollow viscera, comprising an implantable anastomosis device configured for compression-based anastomosis on two sections of hollow viscera, the implantable anastomosis device comprising a first clamping ring (3a) and a second clamping ring (3b), the first clamping ring comprising a permanent magnet ring core (12) and the second clamping ring comprising either a second permanent magnet ring core (12b) or a ferromagnetic ring core. The anastomosis device further comprises a vibration actuator (4) and a power source (5) connected to the vibration actuator (4), the vibration actuator configured to impart vibration on at least one of the first and second clamping rings.

Description

[0001] P3033PC00

[0002] Implantable Anastomosis Device

[0003] The present invention relates to a temporarily implantable compression-based device to create connections (anastomosis) between hollow viscera, particularly in the gastrointestinal (Gl) tract (upper and low Gl tract).

[0004] In practice, Gl anastomoses are widely performed by means of mechanical staplers and manual sutures, however various mechanical and magnetic ring clamping devices are also known for compression based anastomosis. Common to the known solutions in the area of compression-based anastomotic system is the principle of inducing the formation of the anastomosis via the cycle: compression->ischemia->necrosis->remodeling.

[0005] One of the main patient-related and surgery-related risk factors of a Gl anastomosis procedure is anastomotic leakage. Among patient-related factors, the most significant ones include the presence of metabolic syndrome, a poor (catabolic) nutritional status, immunosuppression (primary or iatrogenic), a preoperative neoadjuvant treatment (radio and / or chemotherapy), and an altered basal microbiome. Some patient-related factors cannot be modified (chronic vascular troubles, pre-operative radio-chemotherapy). Other patient-related factors, particularly the metabolic profile, can be, at least partly, improved in the preoperative phase. Likewise, microbiota can be manipulated, by means of dietary or pharmacological interventions. Among surgery-related factors, the most important element that influence the process of anastomotic healing is the correct intraoperative identification of a well-perfused and oxygenated area where to cut the bowel and make the anastomosis between the remaining proximal and distal segments. During the last decade, intraoperative surgical optical technologies, including fluorescence imaging, multispectral, hyperspectral have made substantial progresses to precisely guide the surgeons and identify the optimal resection site in colorectal surgery, and an increasing body of evidence is being produced confirming the usefulness of image-guided technologies to reduce the occurrence of anastomotic leakage.

[0006] Although the surgeon has the possibility to use imaging technologies to control important risk factors for anastomotic leakage during the surgical procedure, there is still a need to further reduce post operative risks of anastomotic leakage due to non-optimal or poor healing processes.

[0007] A general object of the invention is to provide a compression-based implantable anastomosis device for a surgical connection between two hollow viscera, that simplifiesP3033PC00

[0008] surgical procedures while increasing the quality, reliability and repeatability thereof as well as increasing the strength of the anastomosis interface and reducing the risk of post operative rupture or leakage.

[0009] One of the main applications of the invention is for colorectal anastomosis. However, the invention can be applied to other portions of the Gl tract.

[0010] It is advantageous to provide an implantable anastomosis device that enables a rapid and effective healing of the resected interface tissue.

[0011] It is advantageous to provide an implantable anastomosis device that is easy to manipulate during surgery.

[0012] It is advantageous to provide an implantable anastomosis device that is compact and economical.

[0013] Objects of the invention have been achieved by providing a system according to claim 1. Dependent claims set out various advantageous features of embodiments of the invention.

[0014] Disclosed herein is an implantable anastomosis device for use in a surgical connection between two hollow viscera, comprising an implantable anastomosis device configured for compression-based anastomosis on two sections of hollow viscera, the implantable anastomosis device comprising a first clamping ring and a second clamping ring, the first clamping ring comprising a permanent magnet ring core and the second clamping ring comprising either a second permanent magnet ring core or a ferromagnetic ring core.

[0015] The anastomosis device further comprises a vibration actuator and a power source connected to the vibration actuator, the vibration actuator configured to impart vibration on at least one of the first and second clamping rings.

[0016] In an advantageous embodiment, the vibration actuator is configured, for instance preprogrammed, to operate intermittently over a period of a plurality of days, said plurality of days being in a range between three and ten.

[0017] In an advantageous embodiment, the anastomosis device further comprises a drug received in a drug lodging element mounted on or forming part of at least one of the first and second clamping rings.P3033PC00

[0018] In an advantageous embodiment, the drug lodging element comprises a container section having holes through which the drug elutes out of the drug lodging cavity.

[0019] In an advantageous embodiment, the drug is provided in a gel form with a viscosity in a range 0.1 Pa / S to 70 Pa / s.

[0020] In an advantageous embodiment, the drug is selected from any one or more of Steroids, antibiotics, antiseptics, pre-pro-symbiotics formulas, vitamins, genistein, collagen, nonsteroidal anti-inflammatory drugs, anti-thrombotic agents, hemostatics.

[0021] In an advantageous embodiment, the vibration actuator is mounted on at least the first clamping ring, optionally on both the first and second clamping rings.

[0022] In an advantageous embodiment, the power source comprises a battery mounted on the first clamping ring, electrically connected to the vibration actuator and optionally on the second clamping ring if it is provided with a vibration actuator.

[0023] In an advantageous embodiment, the vibration actuator comprises a rotary micro-motor configured for generating a mechanical vibration when powered.

[0024] In a variant, the vibration actuator comprises a piezoelectric actuator.

[0025] In an advantageous embodiment, there are a plurality of vibration actuators coupled to the first clamping ring and optionally to the second clamping ring, said plurality consisting of two or more than two.

[0026] In an advantageous embodiment, the one or more vibration actuators are mounted in an actuator lodging cavity in the first clamping ring and optionally second clamping ring.

[0027] In an advantageous embodiment, each clamping ring further comprises a bio-compatible outer shell or lining made of a bio-compatible polymer.

[0028] In an advantageous embodiment, the power source includes an energy harvester, preferably an induction coil, mounted on the first clamping ring configured to receive induction energy from an external energy transmitter.P3033PC00

[0029] In an advantageous embodiment, the system further comprises an external controller with an energy transmitter configured to generate an induction field for harvesting by the power source.

[0030] In an advantageous embodiment, the anastomosis device further comprises a communication system, for instance a Bluetooth or nearfield communication system, and an external controller configured to communicate with the communication element mounted on the clamping ring.

[0031] In an advantageous embodiment, the first and / or magnetic ring cores have a fully closed annular shape or are made of two or more ring sections assembled together.

[0032] In an advantageous embodiment, at least of the first or second clamping rings comprises a ferromagnetic armature coupled to the permanent magnet ring core.

[0033] Further advantageous features of the invention will be apparent from the following detailed description of embodiments of the invention and the accompanying illustrations.

[0034] Brief description of the figures

[0035] Figure 1 schematically illustrates a procedure for colorectal-anastomosis using an implantable compression-based anastomosis device;

[0036] Figure 2a is a schematic perspective view of an implantable compression-based anastomosis device according to an embodiment of the invention;

[0037] Figure 2b is a schematic perspective view of a clamping ring of an implantable compressionbased anastomosis device according to an embodiment of the invention;

[0038] Figure 3a is a schematic perspective view of a clamping ring of an implantable compressionbased anastomosis device according to another embodiment of the invention;

[0039] Figure 3b is a schematic perspective view of a clamping ring of an implantable compressionbased anastomosis device according to another embodiment of the invention;

[0040] Figure 3c is a schematic illustration a variant of a magnetization configuration of magnetic cores of an implantable compression-based anastomosis device according to an embodiment of the invention;

[0041] Figure 4a is a schematic perspective view of an implantable compression-based anastomosis device according to yet another embodiment of the invention including a drug elution system;

[0042] Figure 4b is a cross-sectional view of the embodiment of figure 4a;

[0043] Figure 5a is a schematic perspective view of a clamping ring of an implantable compression-P3033PC00

[0044] based anastomosis device according to yet another embodiment of the invention including a drug elution system;

[0045] Figures 5b and 5c are exploded views of the clamping ring of figure 5a;

[0046] Figure 6a is a schematic exploded perspective view of an implantable compression-based anastomosis device according to yet another embodiment of the invention including a drug elution system;

[0047] Figure 6b is a partial cut-away view of figure 6a;

[0048] Figures 7a to 7c are schematic perspective views of an implantable compression-based anastomosis device according to yet another embodiment of the invention including a drug elution system, figure 7a showing an exploded view, figure 7b showing rings of the anastomosis device in an uncoupled state and figure 7c showing the anastomosis rings in a coupled position;

[0049] Figure 8 is a schematic perspective view of a patient with a gastrointestinal anastomosis system including an externally mounted controller, according to an embodiment of the invention.

[0050] Referring to the figures, a gastrointestinal anastomosis system 1 according to embodiments of this invention comprises an implantable compression-based anastomosis device 2. The implantable compression-based anastomosis device 2 according to embodiments of the invention comprises clamping rings 3 including first and second clamping rings 3a, 3b, one or a plurality of vibration actuators 4 mounted on at least one clamping ring, optionally on both clamping rings, and a power source 5 connected to the one or plurality of vibration actuators 4. In certain embodiments, the anastomosis device 2 may further comprise a drug lodging element 7 and a drug 8 held in or on the drug lodging element 7. According to certain embodiments, the gastrointestinal anastomosis system 1 may further comprise a communication system including a first communication element mounted on at least one of the clamping rings and connected to the one or plurality of vibration actuators and the power source.

[0051] The power source 5, in embodiments, comprises a battery mounted on the clamping ring on which the one or plurality of vibration actuators is mounted and is electrically connected to the vibration actuators to supply power thereto for actuating the vibration of the vibration actuator.

[0052] In an alternative embodiment, as illustrated in figure 8, the power source 5 may instead comprise an energy harvester, for instance an induction coil (not shown) and a capacitor or a rechargeable battery for storing energy harvested by the induction coil. An externalP3033PC00

[0053] controller 9 with an induction system 11, for instance carried by a patient 100 against the skin of the patient, may be provided to generate induction fields for harvesting by the induction element on the clamping ring. The energy harvester in the form of an induction coil on the clamping ring could have a coil diameter substantially within the diameter of the annular clamping ring and be mounted against one side of the clamping ring or within a circular groove that runs within the clamping ring or on a separate element, for instance an annular plastic housing that is fixed to the clamping ring or integrally formed with a protective shell of the clamping ring.

[0054] In embodiments where the power source comprises a battery, the battery could be mounted directly on one of the clamping rings on an axial side surface thereof or within a groove or lodging cavity formed in the clamping ring, or in a plastic housing coupled to the clamping ring or integrally formed with a protective shell of the clamping ring.

[0055] An electronic chip or other electronic circuit for controlling the vibration actuators may further be provided either as part of the vibration actuators or connected to the power supply and to the vibration actuators forming a separate component that may be mounted or overmolded in a plastic housing that is coupled to the clamping ring on which the vibration actuator is mounted.

[0056] The clamping rings 3 comprise a first clamping ring 3a and a second clamping ring 3b configured to clamp together by a magnetic force, with a portion of resected tissue 104 clamped therebetween, as illustrated in figure 1.

[0057] At least one of the clamping rings comprises a permanent magnet core 12, the other clamping ring comprising preferably a magnetic core, the two magnetic clamping rings being configured to be oriented such that they attract each other to clamp the resected tissue therebetween.

[0058] In a variant, the second clamping ring may be made of a ferromagnetic material that is attracted by the magnetic force of the permanent magnet ring.

[0059] In a first variant, the magnetic rings may have a continuous integral closed annular shape or may be made of more than one ring segment, for instance two-half segments that form together an annular ring for instance as schematically illustrated in figure 3c. In an embodiment, the two half segments of the magnetic rings have alternate polarity N-S and S-N to create a couple in a forced configuration, for instance as schematically illustrated inP3033PC00

[0060] figure 3c

[0061] In an embodiment, the vibration actuator 4 comprises a micro-motor, for instance a rotary motor having a rotor with an ex-centred centre of gravity that vibrates when the rotor is powered and rotates within the stator. Such vibrating micro-motors are per se well-known in various industries and need not be further described herein.

[0062] In an embodiment, there may be a single micro-motor, however in a preferred embodiment there are two or at least two micro-motors coupled to one of the clamping rings, or optionally to both of the clamping rings. The micro-motor may be mounted in a manner that it projects from a side surface of the clamping ring (e.g. as illustrated in figure 2a), or the magnetic ring core may be provided with a recess within which part or all of the micro-motor is lodged (e.g. as illustrated in figure 2b). Other coupling arrangements of the micro-motor to the magnetic core may be provided, it being understood that the key function of the vibration actuator is to couple to the ring and cause the clamping ring to vibrate.

[0063] In other embodiments, for instance as illustrated in figures 3a or 3b, the vibration actuator 4 may comprise a piezoelectric element coupled to the clamping element, the piezoelectric actuator configured to impart vibration on the clamping ring. Here also only one of the clamping rings may be provided with a piezoelectric vibration actuator or optionally both of the clamping rings may be provided with a piezoelectric vibration actuator.

[0064] The piezoelectric element may be mounted in an actuator lodging cavity within the clamping ring or on an outer surface of the clamping ring.

[0065] As mentioned, at least one of the clamping rings, preferably both of the clamping rings each comprise a magnetic ring core 12 surrounded by a bio-compatible outer shell 6 or lining preferably made of a bio-compatible polymer that may be overmolded or assembled around the magnetic ring core 12.

[0066] In a variant, the communication element may include a Bluetooth or nearfield or other per se known form of short distance communication element for coupling to an external compatible communication system of an external controller 9 that may be used to monitor the vibration actuator and to adjust programming of the vibration actuator and / or to control the drug administration.

[0067] The implantable anastomosis device may further comprise sensors, for instance a drugP3033PC00

[0068] concentration sensor connected to the power source and communication element.

[0069] The communication system may also be configured to receive tuning parameters from an external controller in order to adjust the frequency and / or amplitude of vibration of the vibration actuators.

[0070] The power system and vibration actuators are configured in a preferred embodiment for intermittent operation which may be pre-programmed in the micro-motor or electronic system connected to micro-motor and power source, for instance to vibrate at defined intervals for a predefined vibration time, the power source being dimensioned to supply power for the duration of the anastomosis procedure which may be in a range of five to ten days.

[0071] An example of operating parameters of the vibration actuators would be a duration of vibration in a range of 1 to 30 minutes followed by a pause in a range 10 to 90 minutes for the duration of the anastomotic healing process until the anastomosis device 2 is evacuated and flushed out of the patient’s colon. An example of vibration could be for a duration of ten to sixty minutes at a frequency between five and thirty hertz for instance between 10 and 20 hertz over a duration of the anastomosis which may typically be expected to be in a range of three to fifteen days, typically between four and ten days.

[0072] In an embodiment, the anastomosis device 2 comprises a drug 8, for instance in the form of or contained in a gel received within a drug lodging element 7 that may for instance be in the form of a groove 7a or a tubular portion 7b having holes 7c, orifices or a porous structure that allows the drug to transit from the drug lodging cavity to the surrounding tissue.

[0073] In the embodiment of figure 4, a drug lodging cavity 15 is formed within a tubular portion 13 of the housing 6, allowing for the alignment of the pair of clamping rings 3a, 3b. The drug release is induced by means of a preloaded spring 17, calibrated in function of the viscosity of the drug, that pushes on a sealed annular plunger 19. The drug is released at the anastomotic site via calibrated holes within the shell that houses the magnets.

[0074] In the embodiment of figure 5, each magnet presents a segmented groove forming a drug lodging cavity 15. This segmented groove houses segmented prefilled pockets of drug 8 in a hydrogel / aerogel form. Holes 21 in the magnets allow the content to be delivered into the anastomotic space by slow-release dissolution and / or by means of vibration.P3033PC00

[0075] Figure 6 are schematic views of an implantable compression-based anastomosis device according to yet another embodiment of the invention including a drug elution system. In this embodiment, a drug reservoir having annular shape and made of spongious material (aerogel / hydrogel) is positioned between the magnetic rings. Magnetic rings have a preferred rounded concave profile / shape to better accommodate the spongious ring. Alternatively, one of the rings has a concave profile, to accommodate the spongious material and the other shows a convex profile / shape to increase the attraction force and facilitate alignment. In this alternative configuration, only one drug delivery system is used. Drug delivery is induced by slow dissolution with or without the help of vibrations.

[0076] FIGURE 7 are schematic views of an implantable compression-based anastomosis device according to yet another embodiment of the invention including a drug elution system. A biocompatible outer shell 6 may be made of a cellulose aerogel, having a variable density for instant in the range of 0.1 mg / cm3 to 1 g / cm3. The magnet ring 12 may be lodged in the outer shell 6. The outer shell may for instance be manufactured by additive methods, for instance 3D printing. The aerogel structure can be 3D printed in a customized manner in order to form hollow bigger central chambers or cavities and multiple connected and fillable channels. The cavities and channels can be filled with drugs and modulated vibrations act as the delivery mechanism. The vibrating elements (motors) can be positioned either in the magnetic rings and or in the shell. The positioning of the motors and the vibration parameters also help in modulating the rate and the amount of the drug delivery.

[0077] Figure 8 are schematic views of an external controller of a gastrointestinal anastomosis system according to an embodiment of the invention. An external energy source 11, comprising one or more induction coils, for instance two on opposite sides of the patient 100, are positioned on the patient’s body to induce the implanted compression-based anastomosis device (not seen here) to vibrate. The induction coil is connected to electronics and a power source. The controller can be programmed to deliver specific vibration parameters.

[0078] The drug migration may be enhanced by the vibration caused by actuation of the vibration actuators 4.

[0079] The drugs 8 improve the healing process and may include 1) Antibiotics; 2) Steroids; 3) Antiseptics; 4) Prebiotics; 5) Probiotics; 6) Symbiotics; 7) Genistein; 8) Non-steroidal Anti-Inflammatory Drugs; 9) Haemostatics; 10) Collagen.P3033PC00

[0080] The arrangement of holes 21 will typically be between 4 and 8 in number and have a variable Length to Diameter ratio (L / D), depending on the viscosity of the fluid, for instance a typical length may be between be 3 and 6 mm and diameter between 0.2 and 2 mm.

[0081] In a preferred embodiment, each clamping ring comprises a magnetic ring core 12 comprised of a permanent magnet material, for instance of Neodymium. Typical dimensions of each permanent magnet ring core may be in the range of axial thickness between 3 and 10 mm and diameter of different sized adapted for a range of patients’ morphologies, for instance rings with an outer diameter of 20mm, 25mm, 30 mm. 35mm, 40 mm. The surgeon would select the clamping ring of a specified diameter adapted for the patient to be treated. The radial thickness of the magnetic core is preferably in a range of 3 to 10 mm.

[0082] In an alternative embodiment, the vibration actuator may be positioned at a distance from the clamping rings, for instance provided in a belt carried by the patient positioned overhead the placement of the anastomosis ring and applying power remotely for instance in the form of an inductive external stimulator configured to produce a varying magnetic field that is configured to cause vibration of the magnetic clamping rings by the coupling of the varying external magnetic field to the permanent magnet ring cores of the clamping rings.

[0083] The intermittent vibration for a certain duration during the anastomosis period that may last a few days, improves vascularization and in embodiments where an eluting drug is provided the progressive controlled release of the drug in the surrounding tissue, to speed up the healing process and improve the healing and joining together of the resected tissues.

[0084] Advantageously local application of vibrations on the intestinal wall structure and microenvironment improves vascularization, immune response, mucosal barrier, and stress response. Various degrees of vibration amplitudes and frequencies positively affect the anastomotic healing. Local vibrations induce increased blood flow dynamics at both macro and microcirculatory level. Improved microcirculation stimulates / facilitates the healing process via an improved migration of inflammatory and immune cells and enhanced clearing of proinflammatory stimuli, balancing and controlling profibrotic signals and promote angiogenesis. Collectively, those changes lead to improved primary healing and remodelling and ultimately to a mechanically stronger and healthier anastomosis.

[0085] In studies on cutaneous wound healing [1], reported effective vibration parameters of frequency and amplitude on microcirculation suggest safe ranges of 5-30 Hz and 2.5-4.5P3033PC00

[0086] mm amplitude. More recently, a fundamental research work has reported that the application of 7.8 Hz electromagnetic waves (Schuman Resonance vibration) may contribute to the recovery of skin barrier function by upregulating the expression of several genes involved in skin homeostasis [2],

[0087] Beside the effects on microvascularisation, vibration may advantageously also induce a shift of the local bacteria environment making it more favorable to promote gastrointestinal anastomotic healing. An altered microbiome has been very recently identified as a risk factor for Gl anastomotic complications [3],

[0088] The implantable anastomosis device according to the inventions stimulates an earlier healing and formation of the anastomosis.

[0089] In summary, the benefits of localized vibration at the anastomotic site using a compressionbased anastomotic system that may typically stay in place for 5 to 10 days, according to embodiments of the invention, compared to conventional solutions, are:

[0090] Stronger and less inflammatory anastomosis,

[0091] Earlier anastomosis creation when compared to conventional inactive compressionbased anastomotic systems,

[0092] Improved vascularization with an upregulation of angiogenetic factors,

[0093] Enhanced remodelling with a downregulation of proinflammatory factors and positive balance in the collagen formation,

[0094] Positive shift in microbiome composition.P3033PC00

[0095] Bibliography

[0096] 1. Ennis WJ, Lee C, Gellada K, Corbiere TF, Koh TJ (2016) Advanced Technologies to Improve Wound Healing: Electrical Stimulation, Vibration Therapy, and Ultrasound-What Is the Evidence? Plast Reconstr Surg 138:94S-104S

[0097] 2. Sugiwaki H, Kotani M, Fujita A, Moriwaki S (2024) Effects of Schumann resonance on the proliferation and migration of normal human epidermal keratinocytes and the expression of DEFB1 and SIRT1. J Cosmet Dermatol 23:676-680

[0098] 3. Lehr K, Lange UG, Hipler NM, Vilchez-Vargas R, Hoffmeister A, Feisthammel J, Buchloh D, Schanze D, Zenker M, Gockel I, Link A, Jansen-Winkeln B (2024) Prediction of anastomotic insufficiency based on the mucosal microbiome prior to colorectal surgery: a proof-of-principle study. Sci Rep 14:15335P3033PC00

[0099] List of references

[0100] Medical anastomosis system

[0101] In particular

[0102] -^Gastrointestinal anastomosis system

[0103] Implantable compression-based anastomosis device 2

[0104] Clamping rings 3, 3a, 3b

[0105] Magnetic ring cores 12

[0106] Biocompatible outer shell I lining 6

[0107] Tubular portion 13

[0108] Actuator lodging cavity

[0109] Vibration actuator 4

[0110] Micromotor

[0111] Piezoelectric element

[0112] Power source 5

[0113] Battery

[0114] Energy harvester

[0115] Communication system

[0116] Drug lodging element 7

[0117] Groove 7a

[0118] Tubular portion 13

[0119] Cavity 15

[0120] Holes 21

[0121] Spring 17

[0122] Plunger 19

[0123] Drug 8

[0124] External controllers

[0125] External energy source (induction system) 11 Patient 100

[0126] Gastrointestinal tract 102

[0127] resected tissue 104

Claims

P3033PC00Claims1. Implantable anastomosis device (2) for use in a surgical connection between two hollow viscera, comprising an implantable anastomosis device configured for compressionbased anastomosis on two sections of hollow viscera, the implantable anastomosis device comprising a first clamping ring (3a) and a second clamping ring (3b), the first clamping ring comprising a permanent magnet ring core (12) and the second clamping ring comprising either a second permanent magnet ring core (12b) or a ferromagnetic ring core, characterized in that the anastomosis device further comprises a vibration actuator (4) and a power source (5) connected to the vibration actuator (4), the vibration actuator configured to impart vibration on at least one of the first and second clamping rings.

2. The anastomosis system of claim 1 wherein the vibration actuator is configured, for instance pre-programmed, to operate intermittently over a period of a plurality of days, said plurality of days being in a range between three and ten.

3. The anastomosis system of any preceding claim further comprising a drug (8) received in a drug lodging element (7) mounted on or forming part of at least one of the first and second clamping rings.

4. The anastomosis system of the preceding claim wherein the drug lodging element (7) comprises a container section having holes through which the drug elutes out of the drug lodging cavity.

5. The anastomosis system of any of the two directly preceding claims wherein the drug is selected from any one or more of Steroids, antibiotics, antiseptics, pre-pro-symbiotics formulas, vitamins, genistein, collagen, non-steroidal anti-inflammatory drugs, anti-thrombotic agents, hemostatics.

6. The implantable anastomosis system of any preceding claim wherein the vibration actuator is mounted on at least the first clamping ring, optionally on both the first and second clamping rings.

7. The anastomosis system of the preceding claim wherein the power source (5) comprises a battery mounted on the first clamping ring, electrically connected to the vibration actuator and optionally on the second clamping ring if it is provided with a vibration actuator.P3033PC008. The anastomosis system of any preceding claim wherein the vibration actuator comprises a rotary micro-motor configured for generating a mechanical vibration when powered.

9. The anastomosis system of any preceding claim 1-7 wherein the vibration actuator comprises a piezoelectric actuator.

10. The anastomosis system of any preceding claim wherein there are a plurality of vibration actuators coupled to the first clamping ring and optionally to the second clamping ring, said plurality consisting of two or more than two.

11. The anastomosis system of any preceding claim wherein the one or more vibration actuators are mounted in an actuator lodging cavity in the first clamping ring and optionally second clamping ring.

12. The anastomosis device of any preceding claim wherein each clamping ring further comprises a bio-compatible outer shell or lining made of a bio-compatible polymer.

13. The anastomosis system of any preceding claim wherein the power source includes an energy harvester, preferably an induction coil, mounted on the first clamping ring configured to receive induction energy from an external energy transmitter.

14. The anastomosis system of any preceding claim wherein the anastomosis device further comprises a communication system (6), for instance a Bluetooth or nearfield communication system, and an external controller configured to communicate with the communication element mounted on the clamping ring.

15. The anastomosis system of any preceding claim wherein the first and / or magnetic ring cores have a fully closed annular shape or are made of two or more ring sections assembled together.

Images