Magnetic anastomosis device with embedded drainage mechanism

Abstract

A magnetic stapling device with an embedded drainage mechanism includes a magnet coupled to a wire that can change from a straight wire to a coil shape when placed within a body. The coils apply a compressive force to a tissue layer sandwiched between the coil loops. The compressive force is enhanced by attraction between magnets coupled to adjacent loops of the coil and causes the coil to cut the tissue layer, forming an anastomosis. One end of the wire is preferably provided with a connection member, such as a screw or a nut, for connection with a delivery device. An expandable drainage mechanism, such as a stent, is located on or around the stapling device.

Description

[0001] This application is a divisional application of an application with an application date of April 10, 2020, application number 202080042576.8, and invention name “Magnetic anastomosis device with embedded drainage mechanism”.

[0002] Cross-references

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 832,154, filed on April 10, 2019, entitled “Magnetic Anastomotic Device with Embedded Stent.”

[0004] This application is also a continuation-in-part of U.S. patent application No. 16 / 171,779, entitled “Magnetic Anastomotic Device and Delivery System,” filed on October 26, 2018, which is a continuation-in-part of U.S. patent application No. 15 / 605,286 of the same title, filed on May 25, 2017, and issued on December 18, 2018 as U.S. Patent No. 10,154,844, which in turn relies on U.S. Provisional Application No. 62 / 425,951, entitled “Magnetic Anastomotic Device and Delivery System,” filed on November 23, 2016, U.S. Provisional Application No. 62 / 408,795, entitled “Magnetic Anastomotic Device and Delivery System,” filed on October 16, 2016, and U.S. Provisional Application No. 62 / 366,185, entitled “Magnetic Anastomotic Device and Delivery System,” filed on July 25, 2016.

[0005] All of the above applications are incorporated herein by reference in their entirety. Technical Field

[0006] The present invention relates to the placement of a magnetic compression anastomosis device in the human body, and more particularly, to a magnetic compression anastomosis forming device comprising a mechanism for forming an immediate opening at a predetermined position in the body during anastomosis. Background Art

[0007] Prior art devices for forming anastomosis typically include a puncture tip that is dangerous and may cause damage to adjacent organs. These instruments typically use a grasping mechanism that may be difficult to operate. In addition, the operation of some prior art instruments requires two punctures, which may increase the chance of leakage from the puncture site through the grasping forceps. In addition, some prior art devices can only be opposed to adjacent walls without sufficient pressure to cause damage and necrosis of intervening tissues to form a sufficiently large anastomosis that remains open for a long time to provide sufficient drainage. Additional intervention is required to create a large opening. Although stents made of materials such as shape memory alloys (SMA) are known, which are inserted into the human body through an endoscope for forming anastomosis and draining pancreatic pseudocysts, the use of these devices requires multiple interventions to place and remove the stents, as well as to deal with some complications, such as infection, bleeding, displacement, and frequent blockages caused by debris in the pancreatic juice.

[0008] In addition, prior art magnetic anastomosis methods typically require the use of two separate mating devices, which are placed in two adjacent organs. The first device is delivered to the lumen of the first organ and the second device is delivered to the lumen of the second organ. The magnetic force draws the two devices closer, capturing and compressing portions of the walls of the two organs between the devices, ultimately leading to tissue necrosis and anastomosis formation. These devices typically have a single-loop polygonal deployment configuration with no out-of-plane curvature. These devices typically contain additional features to help form the desired deployment shape, such as an exoskeleton and guide and opening / closing elements.

[0009] Therefore, there is a need for a compact and efficient anastomotic device that can be easily delivered in the human body without the need for grasping forceps. There is also a need for an anastomotic device that can be placed by a single operator through a single endoscopic procedure, and the entire device is delivered through a single puncture in the organ wall through endoscopic surgery. It is best not to have a sharp puncture mechanism in a device that uses mechanical force to puncture. The puncture mechanism is preferably separated from the anastomotic device and does not remain in the body with the anastomotic device, thereby reducing the possibility of damage to the internal organs. In addition, there is a need for an anastomotic device that applies a sufficiently large compressive force on the organ wall to form an anastomosis between the organs while maintaining a small enough profile to be delivered through an endoscope or laparoscope or other minimally invasive tools. There is also a need for an anastomotic device that does not rely solely on magnetic forces for correct orientation and positioning in the human body and does not require precise manual positioning of two separate compression elements. There is also a need for an anastomotic device that can connect two hollow organs via a stent without the need to advance an endoscope or laparoscope into the two organs, and the device can be placed by endoscopically or laparoscopically accessing a first of the two organs while simultaneously accessing the second organ via a device delivery catheter. There is also a need for a compression anastomotic device that provides immediate fluid communication and drainage while minimizing anastomotic leaks. Finally, there is a need for a device that can effectively deliver and insert a drainage element, such as a stent, at a location within the human body. Summary of the invention

[0010] The present specification discloses an anastomotic device, comprising: a metal wire, wherein the metal wire has a first state and a second state, wherein in the first state, the metal wire has a substantially linear form, wherein in the second state, the metal wire forms a coil having at least a first loop and a second loop, and wherein when exposed to a temperature greater than a threshold value, the metal wire is adapted to transition from the first state to the second state, and wherein the first loop is connected to the second loop by a bridging segment, the bridging segment comprising a predetermined length of the metal wire, such that the metal wire is able to coil into the first loop in a first direction when changing from the first state to the second state , and coiled into the second ring in an opposite second direction; a plurality of magnets positioned on the first ring and the second ring, wherein each of the plurality of magnets has an inner cavity through which the metal wire extends, wherein in each of the first ring and the second ring, a portion of adjacent magnets of the plurality of magnets are configured not to be connected to each other, and wherein a portion of the plurality of magnets in the first ring is configured to attract a portion of the plurality of magnets in the second ring; and a stent positioned on the bridging segment, wherein the stent is expandable from a first contracted state to a second expanded state, wherein the stent has an inner cavity through which the bridging segment extends.

[0011] Optionally, the bridging section on which the stent is located is not coiled.

[0012] Optionally, the tip of the wire is coupled to a cautery tip made of a ceramic material for penetrating body tissue.

[0013] Optionally, in the second state, the metal wire forms a coil having at least four coil loops.

[0014] Optionally, before positioning the device in a body cavity via a catheter, the anastomotic device is packaged in a shape-setting mold, the shape-setting mold maintaining the device in the second state, wherein the wire forms a coil having a first proximal end and a second distal end, the first proximal end comprising a threaded connector for coupling to the catheter, the second distal end having the tip for piercing the adjacent body tissue, and wherein the proximal end and the distal end are bent 15° to 20° toward the center of the coil loop so that the catheter can leave the endoscopic lifter at an angle of at least 30° during positioning the device in the body cavity.

[0015] Optionally, the metal wire is transformed from the first state to the second state by exposing the metal wire to a temperature above 37 degrees Celsius.

[0016] Optionally, the anastomotic device is used to form an anastomosis between a patient's gallbladder and small intestine to treat one of diabetes, obesity and metabolic syndrome.

[0017] Optionally, the anastomotic device is used to form an anastomosis between the patient's gallbladder and small intestine to treat one of gallbladder dysmotility, gallbladder dyskinesia, biliary dyskinesia and biliary pancreatitis.

[0018] Optionally, when the wire changes from the first state to the second state, the bridge section is coiled into an "S" shape.

[0019] Optionally, an end of the first ring not connected to the bridging section turns inwardly toward the center of the first ring.

[0020] Optionally, an end of the second ring not connected to the bridging section turns inwardly toward the center of the second ring.

[0021] Optionally, the anastomosis device further comprises a non-ferromagnetic spacer located between adjacent magnets of the plurality of magnets.

[0022] Optionally, the metal wire comprises a shape memory alloy.

[0023] The present specification also discloses an anastomosis device, comprising: a metal wire including a first part, a second part and a connecting part between the first part and the second part; a first plurality of magnets coaxially positioned around the first part of the metal wire; a second plurality of magnets coaxially positioned around the second part of the metal wire; and a bracket covering the connecting part of the metal wire.

[0024] Optionally, the anastomotic device further comprises a non-ferromagnetic spacer located between adjacent magnets of the first plurality of magnets and the second plurality of magnets.

[0025] Optionally, the metal wire comprises a shape memory alloy.

[0026] Optionally, the first portion, the second portion and the connecting portion of the wire have a first state and a second state, wherein in the first state, the first portion, the second portion and the connecting portion of the wire have a substantially linear form, and wherein in the second state, the first portion and the second portion of the wire form a coiled shape, and the connecting portion of the wire forms an "S" shape, and wherein the first portion, the second portion and the connecting portion of the wire are adapted to transition from the first state to the second state when exposed to a temperature greater than a threshold value. Optionally, the first portion, the second portion and the connecting portion of the wire are transitioned from the first state to the second state by exposing the wire to a temperature greater than 37 degrees Celsius.

[0027] Optionally, the stent is expandable from a first contracted state to a second expanded state.

[0028] Optionally, the stent has an inner lumen through which the connecting member extends.

[0029] Optionally, the first plurality of magnets and the second plurality of magnets are covered with a PTFE material.

[0030] Optionally, the tip of the wire is coupled to a cautery tip made of a ceramic material for penetrating body tissue.

[0031] The present specification also discloses a delivery device for placing an anastomotic device at a predetermined position in an organ, the delivery device comprising: a handle comprising an inner shaft coaxially surrounded by an outer tube; and a main body comprising a tubular sheath coaxially positioned around the inner shaft, the inner shaft comprising a plurality of grooves for guiding the anastomotic device; wherein during placement of the anastomotic device at the predetermined position through the tubular sheath, the inner shaft rotates relative to the outer tube, and wherein during at least a portion of the placement, the grooves enable the inner shaft to rotate within the outer tube.

[0032] The specification also discloses a method for forming an anastomosis and embedding a stent between two adjacent body tissues, comprising: positioning an anastomosis device in a body cavity through a catheter, the body cavity being close to at least one of the adjacent body tissues, wherein the anastomosis device comprises: a metal wire, wherein the metal wire has a first state and a second state, wherein in the first state, the metal wire has a substantially linear form, wherein in the second state, the metal wire forms a coil having at least a first loop and a second loop, and wherein when exposed to a temperature greater than a threshold, the metal wire is adapted to transition from the first state to the second state; a plurality of magnets positioned on a first portion of the metal wire, wherein each of the plurality of magnets has an inner cavity through which the metal wire extends, wherein in each of the first loop and the second loop, adjacent ones of the plurality of magnets a portion of the magnets being configured not to be connected to each other, and wherein a portion of the plurality of magnets in the first ring being configured to attract a portion of the plurality of magnets in the second ring; and a stent positioned on the second portion of the wire, wherein the stent is expandable from a first contracted state to a second expanded state, wherein the stent has an inner cavity through which the wire extends, and wherein the second portion of the wire does not include any of the plurality of magnets; piercing the adjacent body tissues and positioning the anastomosis device through the hole created by the piercing; releasing the anastomosis device so that when it transitions from the first state to the second state, tissue between the two adjacent body tissues is clamped between the first ring and the second ring, thereby being compressed and causing anastomosis, and the stent is located between the adjacent body tissues.

[0033] Optionally, the anastomosis device further comprises a non-ferromagnetic spacer located between adjacent magnets of the plurality of magnets. Optionally, the length of each non-ferromagnetic spacer is sufficient to keep the attraction force between the opposite magnetic poles of the adjacent magnets lower than the bending force of the coil.

[0034] Optionally, when in the second state, the maximum cross-sectional diameter of the first ring and the second ring is in the range of 5 mm to 50 mm.

[0035] Optionally, each of the plurality of magnets has a maximum cross-sectional length or diameter in the range of 0.2 mm to 7 mm and a pulling force in the range of 0.01 lb to 4 lb.

[0036] Optionally, in the first ring and the second ring, at least 50% of the adjacent magnets of the plurality of magnets are arranged with the same poles facing each other, thereby generating a repulsive force between the adjacent magnets in the first ring of the coil and a repulsive force between the adjacent magnets in the second ring.

[0037] Optionally, at least one end of the wire is connected to a delivery device.

[0038] Optionally, the metal wire comprises a shape memory alloy.

[0039] Optionally, the threshold is 20 degrees Celsius.

[0040] Optionally, the coil has at least one loop close to the first loop and at least one loop far from the second loop.

[0041] Optionally, each of the plurality of magnets is cylindrical and is a rare earth magnet covered with at least one of gold, nickel, Teflon, parylene, copper, zinc, silicone, epoxy and titanium.

[0042] Optionally, the method further comprises, before releasing the stapling device, heating the stapling device by passing an electric current through the stapling device to assist the transition from the first state to the second state.

[0043] Optionally, the diameter of the metal wire is between 0.1 mm and 10 mm, and the length is between 1 cm and 250 cm.

[0044] Optionally, the wire has a diameter between 0.1 mm and 6 mm and has a maximum strain of less than 10% in the first state, and wherein the maximum cross-sectional dimensions of the first and second loops in the second state are in the range of 5 mm to 60 mm.

[0045] Optionally, the adjacent body tissues include a gallbladder and a duodenum, and a maximum diameter of the first ring and the second ring is less than or equal to 30 mm.

[0046] Optionally, the adjacent body tissue comprises pancreatic tissue, and the maximum diameter of the first ring and the second ring is greater than or equal to 5 mm.

[0047] Optionally, the adjacent body tissue includes bile duct tissue, and the maximum diameter of the first ring and the second ring is greater than or equal to 5 mm.

[0048] Optionally, the diameter of the metal wire is less than 0.5 mm, and wherein the maximum cross-sectional dimension of the first ring and the second ring is less than or equal to 15 mm.

[0049] Optionally, the diameter of the metal wire is in the range of 0.5 mm to 1.0 mm, and wherein the maximum cross-sectional dimensions of the first ring and the second ring are in the range of 10 mm to 45 mm.

[0050] Optionally, the diameter of the metal wire is greater than 1 mm, and wherein the maximum cross-sectional dimension of the first ring and the second ring is greater than 20 mm.

[0051] Optionally, the first ring and the second ring have at least one of a circle, a polygon, and a star shape having four or more points.

[0052] Optionally, a portion of said adjacent magnets of said plurality of magnets on the same ring are configured to repel each other.

[0053] Optionally, the support comprises a middle portion defined by a first radius and an end portion defined by a second radius, and wherein the second radius is greater than the first radius.

[0054] Optionally, the stent comprises a wire mesh covered by a biocompatible material.

[0055] Optionally, the stent is fixed to the wire by suturing, crimping, gluing or welding.

[0056] Optionally, the support is a cylinder defined by a length and a radius, wherein the radius is constant over a portion of the length.

[0057] Optionally, the stent is a cylinder defined by a length and a radius, wherein the radius is not constant over a portion of the length.

[0058] The foregoing and other embodiments of the present invention will be described in more depth in the figures and detailed description provided below. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] These and other features and advantages of the present invention will be better understood by reference to the detailed description when considered in conjunction with the accompanying drawings:

[0060] Figure 1 A straight shape memory alloy (SMA) wire is shown coiled in a human body according to one embodiment of the present specification;

[0061] Figure 2 shows a plurality of magnets passing through a loop of SMA wire according to one embodiment of the present specification;

[0062] Figure 3A An embodiment of the present specification is shown in which a gallbladder with gallstones is punctured using an endoscope to place an SMA wire to form an anastomosis;

[0063] Figure 3B According to one embodiment of the present specification, the SMA coil is Figure 3A The anastomosis between the gallbladder and duodenum is shown;

[0064] Figure 3C 1 shows another embodiment of the present specification, in which an SMA coil threaded with a magnet forms an anastomosis between the gallbladder and the duodenum;

[0065] Figure 3D According to one embodiment of this specification Figure 3C A close-up view of the SMA coil with a magnet is shown;

[0066] Figure 4A shows the first stage of the anastomosis process according to one embodiment of the present specification;

[0067] Figure 4B An embodiment according to the present specification is shown. Figure 4A The second stage of the anastomosis process is shown;

[0068] Figure 4C An embodiment according to the present specification is shown. Figure 4A and Figure 4B The third stage of the anastomosis process is shown;

[0069] Figure 4D An embodiment according to the present specification is shown as Figure 4A , Figure 4B and Figure 4C The fourth and final stage of the anastomosis process is shown:

[0070] Figure 5 shows a table showing exemplary dimensions of SMA wires for forming anastomoses according to an embodiment of the present specification;

[0071] Figure 6 A square SMA coil coupled with a magnet to form a fit is shown according to one embodiment of the present specification;

[0072] Fig. 7A shows a hexagonal SMA coil coupled with a magnet to form a fit according to one embodiment of the present specification;

[0073] Figure 7B An embodiment according to the present specification is shown. Fig. 7A Exemplary dimensions of a hexagonal SMA coil are shown;

[0074] Figure 7C A first decagonal SMA coil coupled with a magnet to form a fit is shown according to one embodiment of the present specification;

[0075] Fig.7D A twentieth decagonal SMA coil coupled with a magnet to form a fit is shown according to another embodiment of the present specification;

[0076] Fig. 7E shows exemplary dimensions of a decagonal SMA coil coupled with a magnet to form a fit according to one embodiment of the present specification;

[0077] Figure 7F A dodecagonal SMA coil coupled with a magnet to form a fit is shown according to one embodiment of the present specification;

[0078] Figure 7G shows exemplary dimensions of a hexagonal SMA coil according to one embodiment of the present specification;

[0079] Figure 7H shows exemplary dimensions of an octagonal SMA coil according to one embodiment of the present specification;

[0080] Fig.7I shows exemplary dimensions of a decagonal SMA coil according to one embodiment of the present specification;

[0081] Figure 7J shows exemplary dimensions of a dodecagonal SMA coil according to one embodiment of the present specification;

[0082] Figure 7K shows exemplary dimensions of a tetradecagonal SMA coil according to one embodiment of the present specification;

[0083] Figure 8 shows a process of forming anastomosis by using an SMA coil according to one embodiment of the present specification;

[0084] Fig.9A shows the walls of two organs compressed between loops of an SMA coil according to one embodiment of the present specification;

[0085] Fig. 9B shows the walls of two organs compressed between loops of an SMA coil, the compression force being enhanced by the use of magnets, according to one embodiment of the present specification;

[0086] Fig.10 shows the walls of two organs compressed between a ring of an SMA coil and a magnet according to one embodiment of the present specification;

[0087] Fig.11 shows a plurality of magnets coupled to a loop of an SMA coil to form a coincidence according to one embodiment of the present specification;

[0088] Fig.12 shows a plurality of magnets coupled to a loop of an SMA coil to form a coincidence according to another embodiment of the present specification;

[0089] Fig.13shows placement of magnets coupled to adjacent loops of an SMA coil to form a coincidence according to one embodiment of the present specification;

[0090] Fig.14A An exemplary SMA wire is shown coupled to a magnet to form an anastomosis prior to placement in the body according to one embodiment of the present specification;

[0091] Fig. 14B shows an embodiment of the present specification in the intermediate placement stage and Fig.14A An exemplary SMA wire coupled to a magnet is shown;

[0092] Fig. 14C The embodiment of the present specification shows a Fig.14A The magnets shown are coupled to form an exemplary SMA wire conformation;

[0093] Fig.14D An exemplary SMA wire coupled to a magnet to form an anastomosis prior to placement in the body according to another embodiment of the present specification is shown;

[0094] Fig.14E shows an embodiment of the present specification in the intermediate placement stage and Fig.14D An exemplary SMA wire coupled to a magnet is shown;

[0095] Fig.14F The embodiment of the present specification shows a Fig.14D The magnets shown are coupled to form an exemplary SMA wire conformation;

[0096] Fig.15A An exemplary SMA wire coupled to a magnet to form an anastomosis prior to placement in the body according to another embodiment of the present specification is shown;

[0097] Fig. 15B shows an embodiment of the present specification in the intermediate placement stage and Fig.15A An exemplary SMA wire coupled to a magnet is shown;

[0098] Fig. 15C The embodiment of the present specification shows a Fig.15A The magnets shown are coupled to form an exemplary SMA wire conformation;

[0099] Fig.15D An exemplary SMA wire coupled to a magnet to form an anastomosis prior to placement in the body according to yet another embodiment of the present specification is shown;

[0100] Fig.15Eshows an embodiment of the present specification in the intermediate placement stage and Fig.15D An exemplary SMA wire coupled to a magnet is shown;

[0101] Fig.15F The embodiment of the present specification shows a Fig.15D The magnets shown are coupled to form an exemplary SMA wire conformation;

[0102] Figure 15G is a graph showing the pressure exerted by a loop of a coil on body tissue as the distance between magnets on the coil decreases according to one embodiment of the present specification;

[0103] Fig.16A shows an exemplary circular SMA coil for forming anastomosis according to one embodiment of the present specification;

[0104] Fig. 16B An exemplary circular SMA coil having a cutting edge for forming anastomosis according to one embodiment of the present specification is shown;

[0105] Fig. 16C An exemplary square SMA coil for forming an anastomosis is shown according to one embodiment of the present specification;

[0106] Fig.17A An exemplary device according to one embodiment of the present specification is shown, the device comprising a circular magnet coupled to an SMA coil for forming an anastomosis;

[0107] Fig. 17B An exemplary apparatus according to one embodiment of the present specification is shown, the apparatus comprising circular magnets coupled to an SMA coil for forming an anastomosis, wherein at least one of the magnets comprises a cutting edge;

[0108] Fig. 17C An exemplary device according to one embodiment of the present specification is shown, the device comprising a square magnet coupled to an SMA coil having a serrated edge for forming a fit;

[0109] Fig.17D An exemplary device according to another embodiment of the present specification is shown, the device comprising a square magnet coupled to an SMA coil for forming an anastomosis;

[0110] Fig.17E An exemplary apparatus according to one embodiment of the present specification is shown, the apparatus comprising square magnets coupled to an SMA coil for forming anastomosis, wherein at least one of the magnets comprises a cutting edge;

[0111] Fig.17Fshows a cross-sectional view of an exemplary device according to one embodiment of the present specification, the device comprising a circular magnet coupled to an SMA coil for forming anastomosis, wherein the magnet comprises a convex edge to facilitate cutting;

[0112] Figure 17G shows a cross-sectional view of an exemplary device according to one embodiment of the present specification, the device comprising a square magnet coupled to an SMA coil for forming anastomosis, wherein the magnet comprises a convex edge to facilitate cutting;

[0113] Fig.18A shows a first configuration of a plurality of magnets arranged around a ring for forming a conforming SMA wire coil in accordance with one embodiment of the present specification;

[0114] Fig.18B shows a second configuration of a plurality of magnets arranged around a ring for forming a conforming SMA wire coil according to another embodiment of the present specification;

[0115] Fig.18C shows a third configuration of a plurality of magnets arranged around a ring separated by non-ferromagnetic spacers to form conforming SMA wire coils in accordance with an embodiment of the present specification;

[0116] Fig.18D shows a fourth configuration of a plurality of magnets arranged around a ring separated by non-ferromagnetic spacers to form conforming SMA wire coils according to another embodiment of the present specification;

[0117] Fig.18E shows a fifth configuration of magnets surrounding a ring for forming a conforming SMA coil in accordance with one embodiment of the present specification;

[0118] Fig.18F shows a sixth configuration of magnets surrounding a ring for forming a conforming SMA coil in accordance with one embodiment of the present specification;

[0119] Fig.19A shows a first step of forming an anastomosis between two organs in a human body according to one embodiment of the present specification;

[0120] Fig.19B shows a second step of forming an anastomosis between two organs in a human body according to one embodiment of the present specification;

[0121] Fig.19C shows a third step of forming an anastomosis between two organs in a human body according to one embodiment of the present specification;

[0122] Fig. 20AA non-ablative needle for delivering an SMA coil in vivo is shown according to one embodiment of the present specification;

[0123] Fig. 20B An embodiment according to the present specification is shown. Fig. 20A The handle of the non-cautery needle shown;

[0124] Fig.21 An ablation needle device according to one embodiment of the present specification is shown, the ablation needle device being used to deliver an SMA coil in vivo via an endoscope;

[0125] Fig. 22 An ablation needle device according to one embodiment of the present specification is shown, which is used to deliver an SMA coil in vivo via an endoscope with the help of a guide wire;

[0126] Fig.23A A mechanism for releasing an SMA coil from a delivery catheter according to one embodiment of the present specification is shown;

[0127] Fig. 23B An embodiment according to the present specification is shown. Fig.23A The delivery catheter shown releases the SMA coil;

[0128] Fig.24A A mechanism for releasing an SMA coil from a delivery catheter according to another embodiment of the present specification is shown;

[0129] Fig. 24B An embodiment according to the present specification is shown. Fig.24A The delivery catheter shown releases the SMA coil;

[0130] Fig.25 is a flow chart showing steps for forming an anastomosis by using an anastomotic device according to one embodiment of the present specification;

[0131] Fig.26A A first view of an exemplary device for forming an anastomosis in a pre-coiled configuration according to one embodiment of the present specification is shown;

[0132] Fig.26B The coiled configuration is shown Fig.26A a second view of a device for forming an anastomosis;

[0133] Fig.26C The coiled configuration is shown Fig.26A A third view of a device for forming an anastomosis;

[0134] Fig.26D shows a coiled configuration Fig.26A A side view of a device for forming an anastomosis;

[0135] Fig.26E shows a coiled configuration Fig.26A An axial view of a device for forming an anastomosis;

[0136] Fig.26F A first exemplary device for forming an anastomosis in a post-placement conical coil configuration is shown according to one embodiment of the present specification;

[0137] Figure 26G A second exemplary apparatus for forming an anastomosis in a post-placement conical coil configuration is shown in accordance with one embodiment of the present specification;

[0138] Fig.26H An embodiment of a device for forming an anastomosis in a post-placement coil configuration is shown, the device comprising a single flange attached to one end of the coil;

[0139] Fig.26I Another embodiment of a device for forming an anastomosis in a post-placement coil configuration is shown, the device comprising a single flange attached to one end of the coil;

[0140] Fig.26J Shows Fig.26I A side view of a device for forming an anastomosis;

[0141] Figure 26K An embodiment of a device for forming an anastomosis in a post-placement coil configuration is shown, the device comprising a flange attached to each end of the coil;

[0142] Figure 26L Another embodiment of a device for forming an anastomosis in a post-placement coil configuration is shown, the device comprising a flange attached to each end of the coil;

[0143] Figure 26M Shows Figure 26L Additional views of a device for forming an anastomosis;

[0144] Fig.26N Shows Figure 26L A side view of a device for forming an anastomosis;

[0145] Fig.26O Shown for manufacturing Figure 26L A mold for anastomotic device having a flange;

[0146] Fig. 27 An SMA coil device for forming an anastomosis with a delivery catheter in a pre-placement configuration according to one embodiment of the present specification is shown;

[0147] Fig.28 An SMA coil device for forming an anastomosis with a delivery catheter in a pre-placement configuration according to another embodiment of the present specification is shown;

[0148] Fig.29A shows a cautery tip for placement with an anastomotic coil device according to various embodiments of the present specification;

[0149] Fig.29B An anastomotic coil device with a cautery tip is shown in a pre-placement configuration according to one embodiment of the present specification;

[0150] Fig. 30A shows a side cross-sectional view of an anastomotic coil device having a distal cautery tip in a pre-placement configuration according to one embodiment of the present specification;

[0151] Fig. 30B Shows Fig. 30A an enlarged view of the portion marked 3030;

[0152] Fig. 30C Shows Fig. 30A an enlarged view of the portion marked 3040;

[0153] Fig.30D Shows Fig. 30A Another view of a cautery-capable anastomotic coil device having a cautery tip is shown;

[0154] Fig.30E Shows Fig. 30A An enlarged view of the proximal stop of the anastomotic coil device and the coupling mechanism of the pusher catheter is shown;

[0155] Fig.30F Shown with Fig. 30A A close up view of a cautery tip coupled to a cautery electrode of the anastomotic coil device is shown;

[0156] Figure 30G Shows Fig.30F Front view of the cautery tip shown;

[0157] Fig. 30H Shows Fig.30F A side cross-sectional view of the cautery tip and cautery electrode is shown;

[0158] Fig. 30I Shows Fig.30F The cautery electrode shown;

[0159] Fig.31A A cross-sectional view of a triple lumen catheter for delivering an anastomotic coil device according to one embodiment of the present specification is shown;

[0160] Fig.31B A side cross-sectional view showing an anastomotic coil device in a pre-placement configuration and a guidewire enclosed in a catheter for delivery of the anastomotic coil device according to one embodiment of the present specification;

[0161] Fig.31C Shown along Fig.31B A cross-sectional view of the CC axis is shown;

[0162] Fig.31D Shown along Fig.31B A cross-sectional view of the BB axis is shown;

[0163] Fig.31E Shown for conveying Fig.31B Another view of the catheter and guidewire of the anastomotic coil device is shown;

[0164] Fig.32A shows a cross-sectional view of an anastomotic coil device in a pre-placement configuration disposed in a delivery catheter according to another embodiment of the present specification;

[0165] Fig.32B Shown along Fig.32A A cross-sectional view of the BB axis is shown;

[0166] Fig.32C Shown along Fig.32A A cross-sectional view of the CC axis is shown;

[0167] Fig.32D Shown along Fig.32A A cross-sectional view of the DD axis is shown;

[0168] Fig.32E Shows Fig.32A An enlarged view of the conductor head is shown;

[0169] Fig.32F Shows Fig.32A The anastomotic coil device is shown in a post-placement configuration after delivery in vivo;

[0170] Figure 32G Shows Fig.32F A cross-sectional view of the anastomotic coil device is shown;

[0171] Fig.32H Shown as Fig.32B O-rings for the spacers shown;

[0172] Fig.33A A dual-handle delivery device for delivering an anastomotic coil device provided with a cautery tip according to one embodiment of the present specification is shown;

[0173] Fig.33B Shows Fig.33A an enlarged view of the second handle shown;

[0174] Fig.34AA cross-sectional view of a dual-handle delivery device for delivering an anastomotic coil device provided with a cautery tip according to one embodiment of the present specification is shown;

[0175] Fig.34B Shows Fig.34A An enlarged cross-sectional view of the tip portion is shown;

[0176] Fig.34C Shows Fig.34B a cross-sectional view of the tip portion shown;

[0177] Fig.34D Shows Fig.34A An enlarged cross-sectional view of a guidewire portion is shown;

[0178] Fig.34E Shows Fig.34D A cross-sectional view of the guidewire portion shown;

[0179] Fig.34F Shows Fig.34A An enlarged cross-sectional view of the handle portion is shown;

[0180] Fig.35 is a flow chart showing steps for forming an anastomosis by using a shape memory wire and magnetic compression forces between adjacent organs or structures according to one embodiment of the present specification;

[0181] Fig.36 is a flow chart showing steps for forming an anastomosis by using a shape memory coil with a magnet between adjacent organs according to one embodiment of the present specification;

[0182] Fig.37 is a flow chart showing steps for forming an anastomosis by using a shape memory wire and magnetic compression forces between adjacent organs or structures according to one embodiment of the present specification;

[0183] Fig.38 is a flow chart showing steps for forming an anastomosis by using a shape memory coil with a magnet between adjacent organs according to one embodiment of the present specification;

[0184] Fig.39A shows an exemplary magnet for use with a device for forming an anastomosis according to one embodiment of the present specification;

[0185] Fig.39B shows an exemplary magnet for use with a device for forming an anastomosis according to another embodiment of the present specification;

[0186] Fig.39Cis a graph showing the relationship between compression pressure and distance between coil loops provided by a stapling device having one coil loop on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0187] Fig.39D is a graph showing the relationship between compression pressure and the distance between coil loops provided by a stapling device having two coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0188] Fig.39E is a graph showing the relationship between compression pressure and distance between coil loops provided by a stapling device having three coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0189] Fig.39F is a graph showing the relationship between compression pressure and distance between coil loops provided by a stapling device having a magnet with a diameter of 2.0 mm and having a different number of coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0190] Figure 39G is a graph showing the relationship between force and distance between coil loops provided by a stapling device having a magnet having a diameter of 2.0 mm and having a different number of coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0191] Fig.39H is a graph showing the relationship between compression pressure and distance between coil loops provided by a stapling device having a magnet with a diameter of 2.5 mm and having a different number of coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0192] Fig.39I is a graph showing the relationship between force and distance between coil loops provided by a stapling device having a magnet with a diameter of 2.5 mm and having a different number of coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0193] Fig.39J is a graph showing the relationship between compression pressure and distance between coil loops provided by a stapling device having a magnet having a diameter of 3.0 mm and having a different number of coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0194] Figure 39Kis a graph showing the relationship between force and distance between coil loops provided by a stapling device having a magnet having a diameter of 3.0 mm and having a different number of coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification;

[0195] Fig.40A An exemplary device for forming an anastomosis in a pre-coiled configuration according to one embodiment of the present specification is shown;

[0196] Fig.40B shows a coiled configuration Fig.40A a device for forming an anastomosis;

[0197] Fig.40C shows a coiled configuration Fig.40A Another view of a device for forming an anastomosis;

[0198] Fig.40D An example of a method for converting Fig.40A , Fig.40B and Fig.40C The delivery device for delivering the anastomotic device to a predetermined position in the body;

[0199] Fig.40E A connection to an embodiment of the present specification is shown. Fig.40B and Fig.40C The coiled anastomotic device shown Fig.40D The conveying device shown;

[0200] Fig.40F A connection to an embodiment of the present specification is shown. Fig.40B and Fig.40C The coiled anastomotic device shown Fig.40D Another view of the conveying device shown;

[0201] Figure 40G A connection to an embodiment of the present specification is shown. Fig.40B and Fig.40C The coiled anastomotic device shown Fig.40D Another view of the conveying device shown;

[0202] Figure 40H is a flow chart listing the steps involved in a method of placing an anastomotic device using a delivery device according to one embodiment of the present specification.

[0203] Fig.41 A view showing a device including a plurality of rings according to one embodiment of the present specification;

[0204] Fig.42A view showing a device including an expandable stent as a drainage mechanism according to one embodiment of the present specification;

[0205] Fig.43A An image showing a coiled device according to one embodiment of the present specification having a distal end that curves inwardly to prevent an edge or end from being too sharp;

[0206] Fig.43B A side view to scale of a coiled device with an inwardly curved distal end is shown according to one embodiment of the present specification;

[0207] Fig.43C An embodiment according to the present specification is shown. Fig.43B a rear elevational view to scale of the coiled device with the distal end of the coiled device curved inwardly;

[0208] Fig.43D An optional embodiment according to the present specification is shown. Fig.43B Coil device;

[0209] Fig.44A shows a horizontal side view of a dual coil design according to one embodiment of the present specification, wherein PTFE wire and electrical wire connect the two coils, maintaining physical and electrical connectivity;

[0210] Fig.44B shows a front view of a dual coil design according to one embodiment of the present specification, wherein PTFE wire and electrical wire connect the two coils;

[0211] Fig.44C shows a cross-sectional view of a dual coil design according to one embodiment of the present specification, wherein a PTFE wire and an electrical wire connect the two coils;

[0212] Fig.44D A close up view showing a cross section of a proximal coil of a dual coil design according to one embodiment of the present specification, wherein a PTFE wire and an electrical wire connect the two coils;

[0213] Fig.44E shows a side top view of a dual coil design according to one embodiment of the present specification, wherein PTFE wire and electrical wire connect the two coils;

[0214] Fig.44F An embodiment according to the present specification is shown. Fig.44E perspective drawing;

[0215] Fig.45 shows a scissor-cutting action of a placed coil according to one embodiment of the present specification;

[0216] Fig.46Ais an illustration of a device for forming an anastomosis according to one embodiment of the present specification, the device comprising a bridging element and rings having opposite directionality;

[0217] Fig.46B is an illustration of another device for forming an anastomosis according to another embodiment of the present specification, the device comprising another bridging element and a ring having opposite directionality;

[0218] Fig.46C An embodiment according to the present specification is shown. Fig.46B A front view of a coiled stapling device is shown, the device including a tip cover;

[0219] Fig.46D An embodiment according to the present specification is shown. Fig.46C A side view of a coiled stapling device is shown, the device including a tip cover;

[0220] Fig.46E An embodiment according to the present specification is shown. Fig.46C A perspective view of a coiled stapling device is shown, the device including a tip cover;

[0221] Fig.46F An embodiment according to the present specification is shown. Fig.46C Another perspective view of the coiled stapling device is shown, the device including a tip cover;

[0222] Figure 46G An embodiment according to the present specification is shown. Fig.46C Still another perspective view of a coiled stapling device is shown, the device including a tip cover;

[0223] Fig.47A A coiled anastomotic device according to one embodiment of the present specification is shown, comprising a bridging segment and inwardly curved proximal and distal ends;

[0224] Fig.47B Shows Fig.47A Another view of the device shown;

[0225] Fig.47C A coiled anastomotic device made of SMA wire according to one embodiment of the present specification is shown, the device comprising a bridging segment and inwardly curved proximal and distal segments;

[0226] Fig.47D An embodiment according to the present specification is shown. Fig.47A The device shown, wherein no magnets and spacers are placed around the SMA wire;

[0227] Fig.47E Shows Fig.47Da side view of the device shown;

[0228] Fig.47F Shows Fig.47D a perspective view of the device shown;

[0229] Figure 47G Shows Fig.47D Another perspective view of the device shown;

[0230] Figure 47H Shows Fig.47D yet another perspective view of the device shown;

[0231] Fig.47I An embodiment according to the present specification is shown. Fig.47A a side view of the device shown wherein the magnet is plated with a metallic material and wherein the spacer is an O-ring;

[0232] Fig.47J Shows Fig.47I Another side view of the device shown;

[0233] Figure 47K Shows Fig.47I a perspective view of the device shown;

[0234] Figure 47L Shows Fig.47I a front view of the device shown;

[0235] Figure 47M Shows Fig.47I Another perspective view of the device shown;

[0236] Figure 47N An embodiment according to the present specification is shown. Fig.47I A front view of the device shown, wherein the PTFE gasket is provided around the "S" shaped bridging element;

[0237] Fig.47O Shows Figure 47N a side view of the device shown;

[0238] Figure 47P Shows Figure 47N a perspective view of the device shown;

[0239] Figure 47Q Shows Figure 47N The cross-sectional view of the device shown depicts Figure 47N The various elements of the device shown;

[0240] Figure 47R Shows Figure 47N A close-up cross-sectional view of the SMA wire surrounded by the magnets of the device shown;

[0241] Figure 47S Shows Figure 47N Another perspective view of the device shown;

[0242] Figure 47T Another view of a coiled anastomotic device including a bridging segment according to one embodiment of the present specification is shown;

[0243] Fig.48A An anastomotic device according to one embodiment of the present specification is shown, the anastomotic device comprising a bridging segment at least partially covered by a retracted drainage element;

[0244] Fig.48B An anastomotic device according to another embodiment of the present specification is shown, the anastomotic device comprising a bridging segment at least partially covered by an expanded drainage element;

[0245] Fig.48C It shows that some embodiments according to this specification can be used with Fig.48A and Fig.48B a plurality of drainage elements used together with an anastomotic device;

[0246] Fig.49A shows a front view of an anastomotic device according to one embodiment of the present specification, the anastomotic device comprising a magnet and a wire mesh drainage element covering an "S"-shaped bridging element;

[0247] Fig.49B Shows Fig.49A A cross-sectional view of the device shown;

[0248] Fig.49C Shows Fig.49A a perspective view of the device shown;

[0249] Fig.49D Shows Fig.49A Another perspective view of the device shown;

[0250] Fig.50A A side cross-sectional view of a stapling device in a pre-placement state according to one embodiment of the present specification is shown, the stapling device comprising a magnet and a wire mesh drainage element covering a bridging element;

[0251] Fig.50B Shows Fig.50A a side view of the device shown;

[0252] Fig.50C Shows Fig.50A a front view of the device shown;

[0253] Fig.50D Shows Fig.50A a perspective view of the device shown;

[0254] Fig.50E The following figure shows the placement of an embodiment according to the present specification. FIG. 50A to FIG. 50D Devices;

[0255] Fig.50F An embodiment according to the present specification is shown. Fig.50E The device wherein the wire mesh drainage element is separate from the bridging section;

[0256] Figure 50G An embodiment according to the present specification is shown. FIG. 50A to FIG. 50D a perspective view of the device shown and a device for attaching a wire mesh drainage element to a bridging element;

[0257] Figure 50H Shows Figure 50G a side view of the device shown;

[0258] Fig.50I A front view of a stapling device according to one embodiment of the present specification in a deployed state is shown, the stapling device comprising a wire mesh drainage element covered by a membrane and covering a bridging element of a coil;

[0259] Fig.50J The state before placement according to one embodiment of the present specification is shown. Fig.50I A perspective view of an anastomotic device;

[0260] Figure 50K The anastomotic device according to one embodiment of the present specification is shown in a state before placement, the anastomotic device comprising a wire mesh drainage element disposed on a bridging element;

[0261] Figure 50L An embodiment according to the present specification is shown. Figure 50K A view of a wire mesh drainage element shown in a post-placement state extending through a predetermined segment to allow immediate drainage;

[0262] Figure 50M Shows that there is Figure 50L Another view of the device of the wire mesh drainage element shown compressing two adjacent structures and providing immediate drainage between the two adjacent structures;

[0263] Figure 50N A perspective view of an anastomotic device including a wire mesh drainage element according to some embodiments of the present specification is shown;

[0264] Fig.50O Shown is the inclusion Figure 50N A side view of an anastomotic device having a wire mesh drainage element;

[0265] Fig.51AA handle of a delivery device for delivering an anastomotic device to a predetermined position in a body according to one embodiment of the present specification is shown;

[0266] Fig.51B Another handle of the anastomotic device connected to a delivery device according to one embodiment of the present specification is shown, the delivery device being used to deliver the anastomotic device to a predetermined position in a body;

[0267] Fig.51C An anastomotic device according to some embodiments of the present specification is shown, the anastomotic device comprising a wire mesh drainage element attached to a delivery device;

[0268] Fig.52A An embodiment of the present specification is shown in which a magnetic compression device is used to treat achalasia dysfunction of the lower esophageal sphincter (LES) of a patient;

[0269] Fig.52B An enlarged lumen created by a magnetic compression device for treating achalasia in a patient is shown according to one embodiment of the present specification;

[0270] Fig.53A An embodiment according to the present specification is shown for treating gastroparesis dysfunction by forming an enlarged opening in the patient's pylorus using a magnetic compression device;

[0271] Fig.53B An enlarged opening created by a magnetic compression device for treating gastroparesis in a patient is shown according to one embodiment of the present specification;

[0272] Fig.54A Shown is a method of treating a gastrointestinal stricture of a patient's esophagus using a magnetic compression device according to one embodiment of the present specification;

[0273] Fig.54B An enlarged opening created by a magnetic compression device for treating esophageal stricture in a patient according to one embodiment of the present specification is shown;

[0274] Fig.55 is a flow chart illustrating a method of performing colorectal surgery to place a stapling device according to one embodiment of the present specification;

[0275] Fig.56 is a flow chart illustrating a method of performing a gastrojejunostomy to place an anastomotic device according to one embodiment of the present specification;

[0276] Fig.57A shows a human colon that can be resected to remove a diseased portion according to one embodiment of the present specification;

[0277] Fig.57BA human colon is shown with the diseased portion removed and the ends of the resulting colon anastomosed together;

[0278] Fig.57C A human colon is shown in accordance with an embodiment of the present specification, wherein a diseased portion is removed and the ends of the resulting colon are anastomosed together using a magnetic compression anastomosis device;

[0279] Fig.57D Different types of anastomosis using a magnetic compression anastomosis device according to an embodiment of the present specification are shown;

[0280] Fig.57E A side-to-side colon anastomosis formed using a magnetic compression anastomosis device according to an embodiment of the present specification is shown;

[0281] Fig.57F shows an anastomosis formed between a gallbladder and a duodenum using a magnetic compression anastomosis device according to an embodiment of the present specification;

[0282] Fig.58 is a flow chart showing a method for fusing two ends of a resected colon using an anastomotic device according to one embodiment of the present specification;

[0283] Fig.59 is a block diagram of a handle of an anastomotic delivery device including a control mechanism according to one embodiment of the present specification;

[0284] Fig.60 is a flow chart listing steps in a method of forming a side-to-side anastomosis using a magnetic compression stapling device according to an embodiment of the present specification;

[0285] Fig.61 is a flow chart listing steps in a method of forming a side-to-side anastomosis using a magnetic compression stapling device according to an embodiment of the present specification;

[0286] Fig.62 is a flow chart listing steps in a method of forming an anastomosis with immediate fluid patency and delayed fluid patency using a magnetic compression stapling device according to an embodiment of the present specification; and

[0287] Fig.63 is a flow chart listing steps in a method of forming an anastomosis with immediate fluid patency and delayed fluid patency using a magnetic compression stapling device according to other embodiments of the present description. DETAILED DESCRIPTION

[0288] In various embodiments, shape memory alloy (SMA) or smart alloy wire is used to form anastomosis by forming the desired shape and size of the anastomosis and cutting tissue layers in the human body to create an opening or anastomosis. In one embodiment, a straight section of SMA wire or a longitudinally stretched coil or any other substantially planar structure is delivered to the location in the body where the anastomosis is required. In one embodiment, the SMA wire is either superelastic or thermosensitive and curls into a spring-like coil in response to body heat in the body. In various embodiments, the wire has a straight or longitudinally stretched coil or elongated shape at room temperature and a compressed coil shape at human body temperature, which is preferably in the range of 97.7 degrees to 99.5 degrees Fahrenheit. The coil can be in a compressed shape at any temperature above 96 degrees Fahrenheit.

[0289] The compressed coil defines the desired shape and size of the desired anastomosis. The compressed coil generates a compressive force on the tissue sandwiched between the coil loops. The coiling action also causes the wire to cause local ischemia, pressure necrosis and cut a predetermined tissue layer, thereby forming anastomosis between two adjacent body tissues. In one embodiment, multiple magnets are provided on each concentric ring of the coiled wire. The magnets arranged on adjacent rings attract each other, thereby enhancing the cutting action of the coil. In some embodiments, the compression force is provided by the attraction between the coiled wire and the magnets. In some embodiments, the shape of the resulting anastomosis is mainly determined by the shape of the coil, rather than by the force between the magnets. In various embodiments, the number of magnets used and the length of the magnets are determined by the shape, size or time required to form the anastomosis. In various embodiments, the time required to form the anastomosis ranges from one day to fourteen days. In various embodiments, the anastomosis is formed between two sections of SMA wire, between two or more magnets, or between a section of SMA wire and one or more magnets.

[0290] In various embodiments, the anastomotic device comprises a wire on which a plurality of magnets are disposed. In various embodiments, only one anastomotic device is required to form a desired anastomosis. The device is delivered to a first lumen of a first organ by a delivery device, passes through a first wall of the first organ and through a second wall of a second organ, and then enters a second lumen of the second organ, while still at least partially maintaining a delivery configuration on the delivery device. The anastomotic device is then placed so that a distal portion of the device is disposed in the second lumen and a proximal portion is disposed in the first lumen. After placement, the device is curled into a coil shape having one or more coils so that a distal portion of the coil remains in the second lumen and a proximal portion of the coil remains in the first lumen. In other words, only a single anastomotic device as described in the embodiments of the present specification is required to form a desired anastomosis, rather than two separate mating devices as encountered in the prior art, wherein a first device is placed in a first lumen of a first organ and a second device is placed in a second lumen of a second organ.

[0291] In various embodiments, the anastomotic device of the present specification is formed into a coil shape in the deployed configuration, having at least one coil having a proximal end and a distal end, wherein the proximal end and the distal end are at different levels.

[0292] In various embodiments, the placement coil shape of the anastomotic device is formed solely by the action of the shape memory wire and / or the magnetic force of the magnetic member without using any additional guide elements, manipulators, radial members, hinges or opening members.

[0293] It should be understood that the embodiments disclosed herein have several advantages over the prior art. First, the transition of the wire in a non-placed state to a coil structure in a placed state produces an automatic compression action without the need to manually position individual magnetic elements that are not tethered together or positioned relative to each other in a fixed pre-placement or post-placement configuration. More specifically, the alignment of the magnetic elements is achieved by their fixed positions on the wire, and the natural transition of the wire from a straight, elongated member to a coil shape achieves the necessary automatic alignment of the magnetic elements and compression of the tissue. This is because the magnetic elements provided by the embodiments disclosed herein are tethered together or physically coupled so that the magnetic elements have fixed predetermined positions relative to each other in the pre-placement and post-placement configurations. Although sutures, tubes, or other components can be used to establish a fixed relationship, coupling via a wire is preferred.

[0294] Thus, the magnets in the device have a fixed relationship both before and after placement. The relative three-dimensional position of the first magnet is known and fixed relative to the three-dimensional position of the second magnet, both in the non-placed configuration (along the length of the straight wire) and the placed configuration (coil shape). This fixed relationship enables automatic alignment because the user does not need to manually place the magnets relative to each other to a specific position before placement so that they can be properly connected after placement. In other words, when the device is in the placed configuration, the first magnet in the first coil is in a predetermined fixed position relative to the second magnet in the second coil, where the coils are separated by the tissue being anastomosed. Note that the predetermined fixed position can be one of several positions, but each position is predetermined and fixed. When the same device is in the non-placed (straight wire, non-coil) configuration, the same first magnet (along the length of the wire) is in a different (but still predetermined and fixed) position relative to the second magnet (also along the length of the wire). In the placed and non-placed configurations, these two relative positions are fixed and determined, regardless of human intervention. Therefore, the first magnet and the second magnet automatically switch from the first non-placement relative fixed position to the second non-placement relative fixed position, and when the artificial placement device affects the conversion from the non-placement state to the placement state, human intervention does not affect the predetermined fixed position of the first magnet relative to the second magnet in the non-placement state and the predetermined fixed position of the first magnet relative to the second magnet in the placement state.

[0295] In contrast, the prior art teaches separate magnetic assemblies that must be manually aligned relative to each other to achieve the correct compression force (because they are not physically coupled in a fixed manner, i.e., at least one of the pre-placement or post-placement shapes or both shapes). This means that in the non-placed state, the first magnet assembly has no predetermined fixed position relative to the second magnet assembly, because it is different each time, depending on how the assembly is used. This also means that in the placed state, the first magnet has no predetermined fixed position relative to the second magnet.

[0296] Operationally, this self-aligning property improves the safety of the device. Various parts of the body are subject to tissue movement, such as peristalsis of the gastrointestinal tract, which can move or separate the two opposing magnets that compress the tissue. Because the prior art device includes two independently moving magnetic structures, they are very likely to separate and reconnect in different configurations or positions, thereby possibly forming an anastomosis in the wrong tissue, such as in the wrong part of the patient's gastrointestinal tract. In the currently disclosed embodiment, if the first magnetic element on the first coil is attached to the second magnetic element on the second coil, the two magnetic elements are subsequently separated, the separation will only be temporary, and the two magnetic elements will automatically reattach to the target tissue area without manual intervention. First, as described above, the two magnetic elements have a fixed relationship. Second, they are in a fixed position relative to the target tissue because they are inserted into place by piercing the target tissue. Therefore, if temporarily separated, the magnets will not move (because the underlying wire has pierced the target tissue), and once the interfering action subsides, they will coil back to the placement configuration. Thus, two magnetic elements on opposing coils separated by target tissue automatically reattach at least 70% of the time, and most likely at least 90%, 95%, and 99% of the time, after being temporarily separated by anatomical action.

[0297] The aforementioned coupling structure also facilitates the placement process. Instead of placing two separate components on two opposing sides of the tissue to be anastomosed, the physician only needs to place a single device that is used to initially puncture the tissue to be anastomosed and then automatically coils to provide the necessary compression force.

[0298] Second, the embodiments disclosed herein preferably use a solid metal wire, such as a Nitinol wire, to integrally couple the magnetic elements to one another. This has several advantages, including 1) being able to provide a guidewire mechanism that integrates the electrocautery puncture function into the anastomotic device itself; 2) avoiding the use of a tube or structure with any hollow lumen therethrough, which is more complicated to manufacture, more difficult to place reliably, and can also result in a device that is too thick or has a magnet that is too small in profile, thereby reducing the amount of compressive force available; and 3) allowing the physician to place the device in locations that thicker devices or catheters cannot reach, such as pseudocysts. Although a solid metal wire is a preferred embodiment, all of the presently disclosed embodiments may use a hollow tube, such as a hollow Nitinol wire, through which a guidewire may be passed to position the device.

[0299] Third, the embodiments disclosed herein teach a wire having a plurality of magnetic elements that are preferably not fixedly attached to the wire, but rather are closely positioned on the wire and separated from adjacent magnetic elements using non-ferromagnetic spacers. This has several advantages. The disclosed device is simpler to manufacture because each magnetic element does not need to be individually fixed to the wire using solder, pawls, tabs, glue, welding, or friction fit. Instead, the magnetic element can have an inner cavity alone to allow for greater tolerances and be strung on the wire through the inner cavity, and separated from adjacent magnetic elements using non-ferromagnetic spacers, avoiding any additional fixing steps to attach the magnetic element to the wire. This enables each magnetic element to have a fixed position relative to other magnetic elements on the same wire without having to attach each magnetic element to the wire. In addition, the fixed position of each magnetic element with a non-ferromagnetic spacer between them (thereby producing an alternating sequence of magnetic elements and non-ferromagnetic spacers) prevents unnecessary aggregation or movement of magnets. Although the prior art discloses the use of sheaths or protrusions on magnetic elements, such structures do not prevent the magnets from aggregating or moving out of a preferred configuration or arrangement as a whole. In fact, the magnetic elements preferably have smooth surfaces (no raised portions) to allow for more flexible alignment and avoid the need to align non-raised portions with raised portions. However, it should be understood that in a less preferred embodiment, each magnetic element can be attached to the wire and separated from adjacent magnetic elements by spaces (rather than physical non-ferromagnetic spacers made of, for example, plastic or other medically acceptable materials).

[0300] Fourth, the disclosed coil structure allows the application of multiple magnetic layers, thereby increasing the compression force on the tissue surface without increasing the complexity of the medical procedure. If the device of the prior art is used, multiple separate, physically separated magnetic components must be manually matched on both sides of the tissue surface to achieve the effect that the currently disclosed coil structure can automatically achieve: compressing the tissue with multiple magnetic layers on both sides of the tissue, these magnetic layers are automatically aligned with each other, and are in a fixed relative position in both the pre-placement and post-placement configurations. Specifically, the device and method of the present specification only require a single device and a single path to form an anastomosis. The method of the prior art requires two separate accesses to the anastomosis area. In addition, the device of the prior art requires two separate implants, so the doctor needs to enter two different paths through an endoscope or laparoscope. The two independent and different paths are not only more traumatic, but also require additional steps. The device and method of the present specification do not require the additional steps required by the prior art method. Using the device and method of the present specification, one path can complete the positioning of both sides of the anastomosis device. Therefore, the device and method of the present specification have advantages over the prior art, that is, a single implantation procedure is used and no second step is required to position both sides of the anastomosis device.

[0301] The term "and / or" means one or all of the listed elements or any combination of two or more of the listed elements.

[0302] In the description and claims of the present application, each of the words "includes," "comprising," and "having" and various forms thereof are not necessarily limited to the members of the list to which the word may be associated.

[0303] Unless otherwise specified, "a," "an," "the," "one or more," and "at least one" are used interchangeably to mean one or more.

[0304] The term "pre-placement" or "delivery" configuration refers to a configuration in which the solid metal wire upon which the magnetic element or member is placed is substantially straight or linear.

[0305] The term "placed" or "placed" configuration refers to a configuration in which the solid metal wire upon which the magnetic element or member is placed is substantially coiled or helically shaped.

[0306] The term "coil" refers to the entire magnetic stapling device and the term "ring" refers to the single complete wire loop of the "coil", with or without magnets and spacers.

[0307] For any method disclosed herein comprising discrete steps, the steps may be performed in any feasible order. Also, any combination of two or more steps may be performed simultaneously where appropriate.

[0308] In addition, in this article, the enumeration of numerical ranges by endpoints includes all integers or fractions included in the range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). Unless otherwise indicated, all numerals used in the specification and claims to represent the number of components, molecular weight, etc. should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated to the contrary, the numerical parameters set forth in the specification and claims are approximate values, which can vary according to the desired properties sought to be obtained by the present invention. At least, and without attempting to limit the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be interpreted according to the number of reported significant figures and by applying ordinary rounding techniques.

[0309] Although the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, all numerical values ​​inherently contain a range necessarily resulting from the standard deviation found in their respective testing measurements. That is, it should be understood that the dimensions provided herein are critical because they allow the device to be small enough to be delivered to the desired physical space in the body while still having sufficient compression force to form anastomosis.

[0310] This specification is directed to multiple embodiments. The following disclosure is provided to enable a person of ordinary skill in the art to practice the present invention. The language used in this specification should not be interpreted as a general negation of any one specific embodiment, nor should it be used to limit the claims beyond the meaning of the terms used therein. Without departing from the spirit and scope of the present invention, the general principles defined herein can be applied to other embodiments and applications. In addition, the terms and wordings used are for the purpose of describing exemplary embodiments and should not be considered restrictive. Therefore, the present invention will be given the widest scope, which includes many replacements, modifications and equivalents consistent with the disclosed principles and features. For the sake of clarity, details related to technical materials known in the technical field related to the present invention are not described in detail to avoid unnecessarily obscuring the present invention.

[0311] It should be noted here that any feature or component described in connection with a particular embodiment can be used and implemented with any other embodiment, unless explicitly stated otherwise.

[0312] Figure 1A straight SMA wire 102 is shown coiled in a human body according to one embodiment of the present specification. The wire 102 is made of an SMA material such as Nitinol. Shape memory alloy, which may also be referred to as SMA, smart metal, memory metal, memory alloy, muscle wire and / or smart alloy, is an alloy that "remembers" its original shape and can be restored to its pre-deformed shape by heating after deformation. Nitinol changes from martensite to austenite after heating. In one embodiment, the SMA wire 102 is made of a copper-aluminum-nickel alloy. In another embodiment, the SMA wire 102 is made of a nickel-titanium alloy. In one embodiment, the diameter of the wire 102 is in the range of 0.1 to 6 mm, has a maximum strain of less than 10% in an uncoiled position, and has a maximum cross-sectional size of from 5 mm to 60 mm in a coiled position. In one embodiment, for a strain of 5%, the diameter of the coiled wire is less than 15 mm, between 15 mm and 20 mm, and greater than 20 mm when the wire diameter is less than 0.75 mm, between 0.75 mm and 1 mm, and greater than 1 mm, respectively. In one embodiment, for a strain of 10%, the diameter of the coiled wire is 10 mm, 12.5 mm, 15 mm, 17 mm, 20 mm, 25 mm, and 45 mm when the wire diameter is 1 mm, 1.25 mm, 1.5 mm, 1.7 mm, 2 mm, and 2.5 mm, respectively. In one embodiment, for a strain of 6%, the diameter of the coiled wire is 10 mm, 12.5 mm, 15 mm, 17 mm, 20 mm, 25 mm, and 45 mm when the wire diameter is 0.6 mm, 0.75 mm, 0.9 mm, 1.02 mm, 1.2 mm, and 1.5 mm, respectively. Furthermore, in various embodiments, the wire 102 is coiled into at least two loops when delivered into the body.

[0313] A s and A f is the temperature at which the transformation from martensite to austenite begins and ends. When inserted into the human body and placed at the anastomosis site, the wire 102 changes shape and coils into 104 or 106 in response to the higher temperature of the human body relative to room temperature. In various embodiments, the diameter of the wire 102 is in the range of 0.1 mm to 10 mm, and the length of the wire 102 is in the range of 1 cm to 250 cm. In some embodiments, as shown in reference Fig.23A and Fig. 23B As explained, the loop 108 is provided at one or more ends of the wire for attachment to a delivery catheter. f Temperature is less than or equal to 40℃, the A of the wire sThe temperature is less than or equal to 37° C. In various embodiments, the strain on the Nitinol wire in the martensitic shape is less than or equal to 10%. In one embodiment, the coil has a circular cross-section with a radius r, wherein the circumference of the coil is 2πr and the area of ​​the coil is πr 2 , where the coil has a radius of approximately r and an area of ​​πr 2 In some embodiments, the metal wire A f The temperature (transformation temperature) is greater than or equal to 37°C, and a means for heating the wire is provided to assist in heating the wire to transform the wire from its martensitic shape to its austenitic shape. In one embodiment, the means for heating the wire includes passing an electric current through the wire. In some embodiments, the A of the wire f The temperature (transition temperature) is greater than or equal to 20°C.

[0314] Figure 2A plurality of magnets 202a, 202b, 202c, 202d, 202e, 202f are shown passing through loops 204, 206 of SMA wire according to one embodiment of the present specification. The magnets 202a, 202b, 202c, 202d, 202e, 202f pass through the loops 204 and 206 of the coil 200. In one embodiment, the coil 200 is a nitinol wire that is coiled in response to temperature changes. A repulsive force acts between adjacent magnets 202a, 202b, and 202c that are threaded on the same loop 204, thereby maintaining a predetermined distance between the magnets. Similarly, a repulsive force acts between adjacent magnets 202d, 202e, and 202f that are threaded on the same loop 206, thereby maintaining a predetermined distance between the magnets. An attractive force acts between the magnets threaded on the loop 204 and the magnets on the coil 206. Therefore, there is an attraction between magnets 202a and 202d, between magnets 202b and 202e, and between magnets 202c and 202f. The attraction between the magnets on adjacent rings generates a compressive force 207 between the rings of the coil, pulling the rings together to cut the tissue between the rings and form anastomosis. In various embodiments, the compressive force is in the range of 0.1 to 0.5N, and the associated pressure applied to the tissue layer sandwiched between the rings is in the range of 0.15psi to 145psi (0.001 to 1MPa). In one embodiment, at least two magnets are coupled to two adjacent rings of the coil 200, and the wire is coiled into at least two rings. In one embodiment, the magnet is a rare earth magnet covered with a biocompatible material, such as gold, nickel, Teflon, polyparaxylene, copper, zinc, silicone, epoxy or titanium. In one embodiment, the coil 200 includes an RFID tag 210 to help locate the coil 200 after placement and during anastomosis formation. Using an RFID scanner, the location of the coil can be identified through communication with the embedded RFID tag to determine the precise location of the coil within the patient without the need for radiation for visualization. In some embodiments, the magnet is rated N35 or higher.

[0315] In one embodiment, the Nitinol coil applies a pressure of less than or equal to 50 mmHg (0.97 psi) on the tissue, and the combined coil and magnet apply a pressure of greater than 50 mmHg (0.97 psi) on the tissue. In another embodiment, the Nitinol coil applies a pressure of less than or equal to 80 mmHg (1.57 psi) on the tissue, and the combined coil and magnet apply a pressure of greater than 80 mmHg (1.57 psi) on the tissue. In yet another embodiment, the Nitinol coil applies a pressure of less than or equal to 120 mmHg (2.32 psi) on the tissue, and the combined coil and magnet apply a pressure of greater than 120 mmHg (2.32 psi) on the tissue. In yet another embodiment, the Nitinol coil applies a pressure of less than or equal to 150 mmHg (2.90 psi) on the tissue, and the combined coil and magnet apply a pressure of greater than 150 mmHg (2.90 psi) on the tissue. In another embodiment, the nitinol coil applies a pressure less than or equal to 200 mmHg (3.86) on the tissue, and the combined coil and magnet apply a pressure greater than 200 mmHg (3.86) on the tissue. In one embodiment, the coil pressure at each coil tissue interface is sufficient to prevent more than 50% of capillary flow in the tissue. In one embodiment, the coil produces a pressure greater than or equal to 20 mmHg (0.39 psi) at more than one quarter of the coil circumference, and the pressure is relatively evenly distributed between the two semicircles of each coil loop. In one embodiment, the pressure is greater than or equal to 20 mmHg (0.39 psi) at two or more points on opposite sides of each coil loop.

[0316] In one embodiment, as described above, most of the compressive force is initially provided by the SMA coil. However, as the magnets are physically brought closer together, the magnetic compressive force exceeds the compressive force provided by the Nitinol coil and drives the anastomosis formation. In some embodiments, the anastomosis formation process is accelerated by passing an electric current through the coil to heat the coil prior to placement, thereby damaging / coagulating or ablating the intervening tissue.

[0317] Figure 3AA gallbladder 302 with cholecystitis and gallstones 304 is shown endoscopically punctured using a delivery catheter or needle to place an SMA anastomotic device to form an anastomosis according to one embodiment of the present specification. The gallbladder 302 with gallstones 304 is punctured by a delivery catheter or needle 306, which is delivered through an endoscope 308 inserted into the duodenum 310 of the patient. The catheter or needle 306 punctures the wall of the duodenum 310 and the gallbladder 302 so that the gallbladder 302 is connected to the duodenum 310 using a device of the present specification to form an anastomosis for providing drainage to the gallbladder 302 and removing the gallstones 304. In one embodiment, the endoscope 308 is an ultrasound endoscope and the puncture is performed under ultrasound imaging. In another embodiment, the endoscope 308 is a duodenoscope and the puncture is performed under fluorescent imaging.

[0318] Figure 3B According to one embodiment of the present specification, Figure 3A An SMA coil 312 is shown placed between the gallbladder 302 and the duodenum 310 to form an anastomosis. In one embodiment, the SMA coil 312 comprising a nitinol wire is delivered through an endoscope 308 through a hole punctured by a catheter or needle in the wall of the gallbladder 302. Due to exposure to body heat, the nitinol wire changes shape and coils up, holding the tissue of the gallbladder 302 wall and the duodenum 310 wall in place. Figure 3B The coil 312 shown is interposed between the loops of the coil 312, thereby forming an anastomosis between the gallbladder 302 and the duodenum 310. The coiling of the wire 312 causes a compressive force to act on the tissue sandwiched between the coils, thereby cutting the tissue to form the anastomosis. In one embodiment, a magnet can be inserted into the coil 312 to further increase the compressive force, such as Figure 2 and Figure 3C In various embodiments, the anastomosis is formed over a period of time to allow sufficient time for neovascularization of the anastomosis to occur, thereby achieving a secure and stable anastomosis without significant leakage.

[0319] Figure 3C An SMA coil 332 is shown according to another embodiment of the present specification, which is penetrated by magnets 334 to form an anastomosis between a gallbladder 322 and a duodenum 320. In one embodiment, an SMA coil 332 comprising nitinol is penetrated by magnets 334 placed in different / adjacent coil loops. The magnets 334 placed in different coil loops attract each other, thereby further increasing the compression force in the coil 332 and accelerating or improving the cutting of the gallbladder and duodenal walls to form the anastomosis. In one embodiment, one or more incisions or one or more stomas are formed in the wall of the gallbladder and / or duodenum to place the SMA coil 332 penetrated by magnets 334 for forming the anastomosis.

[0320] Figure 3D According to one embodiment of the present specification, Figure 3C 332. A close up view of an SMA coil 332 of magnets is shown. Coil 332 has magnets 334a and 334b ​​threaded in loop 336 and magnets 334c and 334d threaded in loop 338. The poles of magnets 334a and 334b ​​are arranged so that the magnets repel each other, thereby maintaining a constant predetermined distance between each other on loop 336. Similarly, the poles of magnets 334c and 334d are arranged so that the magnets repel each other, thereby maintaining a constant predetermined distance between each other on loop 338. The poles of magnets 334a and 334c are arranged so that the magnets attract each other, thereby pulling the loops 336 and 338 of coil 332 closer together and increasing the compressive force exerted by coil 332 on the tissue layers sandwiched between the loops of coil 332. Similarly, the compressive force is caused by the attractive force between magnets 334b ​​and 334d. As the magnets cut the tissue and get closer, the compressive force gradually increases, slowly accelerating the cutting action and anastomosis formation once the two walls have time to fuse together. This approach reduces the chance of leaks that can occur if the anastomosis is performed too quickly, not allowing enough time for the two adjacent walls to appose and fuse.

[0321] Figure 4A 4 shows a first stage of an anastomosis process according to one embodiment of the present specification. As shown, organ walls 402 and 404 are sandwiched between adjacent loops 407, 409 of a coil 406. In one embodiment, the coil 406 is made of an SMA material, such as Nitinol, and is delivered to the organ as a straight wire or an elongated relatively straight coil that changes shape due to exposure to body heat to form a coil of a predetermined shape and size such that the adjacent organ walls are sandwiched between the coil loops. Reference Figure 3A In one embodiment, organ wall 402 is the wall of gallbladder 302, and organ wall 404 is the adjacent wall of duodenum 410. Figure 4A , magnets 408 and 410 are coupled to loops 412 and 414 of coil 406, respectively. The poles of magnets 408 and 410 are arranged so that the magnets attract each other, thereby pulling loops 407, 412 and 409, 414 closer together and increasing the compressive force applied by coil 406 on organ walls 402 and 404. Over time, the SMA wire applies a relatively steady force, while the magnets will apply a gradually increasing compressive force that accelerates as the anastomosis is formed, thereby causing initial fusion of the walls and cutting through the walls once the two walls are fused. In some embodiments, the compression surface is provided by two opposing magnets or a wire and a magnet.

[0322] Figure 4B An embodiment according to the present specification is shown. Figure 4A The second stage of the anastomosis process is shown in FIG. Figure 4BAs shown, loops 407, 412 and 409, 414 of coil 406 are pulled closer together by magnetic force 413 drawing magnets 408, 410 together, thereby compressing organ walls 402 and 404 between loops 407 and 409, causing ischemia and subsequent neovascularization that fuses the two organ walls. Figure 4C An embodiment according to the present specification is shown. Figure 4A and Figure 4B The third stage of the anastomosis process is shown. As shown, due to the magnetic force 413 between the magnets 408 and 410, the compression force of the coil 406 is further enhanced, resulting in complete ischemia, apoptosis and ischemic necrosis of the tissue in the center of the coil, and causing the loops 407 and 409 of the coil 406 and / or the magnet 408 to cut the organ walls 402 and 404. Figure 4D An embodiment according to the present specification is shown as Figure 4A , Figure 4B and Figure 4C The fourth and final stage of the anastomosis process is shown as the formation of the anastomosis. As shown, the opening / anastomosis 415 is formed due to the coil cutting the organ wall 402, 404, and then the coil falls off and is passed naturally without the need for endoscopy. In one embodiment, the coil is designed to facilitate passage after cutting the wall in an antegrade or retrograde manner. In another embodiment, the coil is configured to remain in the anastomosis and then be removed using an endoscope.

[0323] Figure 5Table 500 is shown, which shows exemplary dimensions of anastomotic devices for forming anastomosis according to one embodiment of the present specification. Column 502 shows exemplary diameters of coils in mm, while columns 504, 506, 508, 510 and 512 show corresponding exemplary lengths of wires coiled into 1, 2, 4, 8 and 16 loops, respectively, in cm. The predetermined diameter of the anastomosis is between 0.5 cm and 5 cm, and the predetermined length of the coil wire is between 3 cm and 250 cm. The preferred diameter of the anastomosis depends on the specific organ, 1-2 cm for the gallbladder, 0.5-1 cm for the bile duct, 1-2 cm for cystic gastrectomy or cystic jejunostomy, and 2-5 cm for gastrojejunostomy of enteroenterostomy. However, these are representative numbers, and in practice, the diameter of the coil will be determined based on the diameter of the organ and the indication being treated. In various embodiments, the diameter of the coil is less than or equal to the diameter of the organ to be anastomosed. For example, in the case of bile duct anastomosis, small intestinal anastomosis, colon anastomosis, gallbladder anastomosis, pseudocyst anastomosis and vascular anastomosis, the diameter of the coil is less than or equal to 10 mm, less than or equal to 30 mm, less than or equal to 60 mm, less than or equal to 30 mm, less than or equal to 30 mm and less than or equal to 25 mm, respectively. The preferred number of loops will depend on the total magnetic force required to form the anastomosis, which in turn depends on the total thickness of the organ wall being anastomosed. In some embodiments, the SMA wire is delivered in vivo by using an endoscope, and therefore, the length of the wire needs to be less than the length of the endoscope. In one embodiment, the length of the SMA wire is less than 250 cm, or more specifically less than 75 cm. In an embodiment where the length of the SMA wire is 75 cm, the number of coil loops obtained is 8. In one embodiment, where the length of the SMA wire is 100 cm, 16 coil loops with a diameter of 2 cm or 8 coil loops with a diameter of 4 cm are obtained. In an embodiment where the length of the SMA wire is 250 cm, 16 coil loops with a diameter of 5 cm are obtained. In addition, in various embodiments, one device has two coil loops, each of which includes 8 magnets, and the other device has 8 coil loops, each of which includes 2 magnets, and each device causes the same compressive force on the tissue sandwiched between the corresponding coil loops. The required size of the anastomosis in the tissue determines the diameter of each coil loop, which in turn determines the number of magnets (and their lengths) used in conjunction with the SMA wire that causes the anastomosis. The required compressive force is a compressive pressure greater than the capillary blood flow in the tissue. In various embodiments, a predetermined minimum pressure needs to be applied by the SMA coil on the anastomosed tissue, and the pressure needs to be distributed along each coil loop. In one embodiment, the pressure is applied at least along four points on each coil loop. In other embodiments, pressure is applied at two or eight points along the circumference of each loop, depending on the size of the loop.

[0324] In various embodiments, the diameter of the SMA wire used for the anastomosis is in the range of 0.1 mm to 6 mm, and the pitch of the coil is less than 10 mm. In various embodiments, the maximum cross-sectional diameter of the SMA coil is in the range of 5 mm to 50 mm, wherein the number of loops in the coil is at least two and at most 100, and the total length of the coil wire is less than or equal to 250 cm.

[0325] The maximum strain in the wire in the straight position (martensitic shape) is less than or equal to 10%. In various embodiments, the diameter of the coil will determine the diameter of the wire. Coils with a diameter less than or equal to 15 mm are preferably made with a wire with a diameter less than or equal to 0.75 mm, coils with a diameter of 15-25 mm are preferably made with a wire with a diameter of 0.75-1.0 mm, and coils with a diameter greater than or equal to 25 mm are preferably made with a wire with a diameter greater than or equal to 1 mm. In various embodiments, the magnet and SMA wire create a pressure of at least 0.15 psi, more preferably at least 1.0 psi, and most preferably at least 2.50 psi at the coil-tissue boundary interface to cut off the blood supply in the tissue. In some embodiments, a pressure of up to 4.0 psi is applied. In various embodiments, the magnet and SMA wire create a pressure equal to or less than 145 psi at the coil-tissue boundary interface.

[0326] In various embodiments, the magnets coupled to the SMA coils are rare earth or permanent magnets, each having a maximum cross-sectional length in the range of 0.2 mm to 7 mm and a pull force in the range of 0.1 lb to 4 lb (0.04-17.8 N). In some embodiments, neodymium magnets with a maximum energy product in the range of 35 to 55 are used. In some embodiments, the magnets are coated with materials such as Teflon, parylene, silicone, epoxy, gold, titanium, nickel, or copper. The ideal operating temperature of the magnet is below 80°C, and the required material grade for the neodymium magnet is N30-N60. Ideally, neodymium magnets of N35-N110, N55, or similar rare earth magnets would be used.

[0327] In various embodiments, by using various embodiments according to this specification (such as 4A to 4D The shape of the anastomosis formed between the two organs is determined by the shape of the coiled SMA wire. For example, a square coil will form a square anastomosis. Figure 6A square SMA coil 600 is shown coupled to magnets 602 to form an anastomosis according to one embodiment of the present specification. The square Nitinol coil 600 is coupled to eight magnets 602, four of which are located on two separate rings 604 and 606. Repulsive forces act between magnets coupled to the same ring, thereby keeping the magnets separated by a predetermined distance. Attractive forces act between corresponding magnets placed on adjacent coils 604 and 606, thereby increasing the compression force of the coil 600 and pulling the coils 604 and 606 closer to each other to form a square incision in the tissue.

[0328] Fig. 7A A hexagonal SMA coil 700 is shown coupled to a magnet 702 to form an anastomosis, in accordance with one embodiment of the present specification. The hexagonally coiled SMA wire 700 coupled to the magnet 702 forms a hexagonal anastomosis between two organs by hexagonally cutting the organ wall. Figure 7B According to one embodiment of the present specification, Fig. 7A Exemplary dimensions of a hexagonal SMA coil 700 are shown. In one embodiment, the distance or spacing 704 or pitch between two loops of the coil 700 is approximately 0.4 mm, the length 706 of one side of the hexagonal loop is approximately 6 mm, and the circumference 708 of the wire forming the coil is approximately 0.4 mm. In various embodiments, the pitch of the coil after it is laid down (austenitic shape) can vary from the diameter of the SMA wire to 5 times the diameter of the wire used in the coil, and always less than the diameter of the coil.

[0329] Figure 7C A decagonal SMA coil 712 is shown coupled to a magnet 714 to form a conformation according to one embodiment of the present specification. Figure 7C , the magnet 714 is coupled to the coil 712 so that the magnet 714 is primarily located on an outer surface of the coil 712 . Fig.7D A decagonal SMA coil 722 is shown coupled to a magnet 724 to form a conformation according to another embodiment of the present specification. Fig.7D , the magnet 724 is coupled to the coil 722 so that the magnet 724 is primarily located on the inner surface of the coil 722 . Figure 7C The coil in is preferred in indications that require the automatic passage of the anastomotic device after the anastomosis is formed, while Fig.7D The coil in is preferred in indications where it is desired that the anastomotic device does not pass automatically after the anastomosis is formed.

[0330] Fig. 7EExemplary dimensions of a decagonal SMA coil 732 coupled to magnets 734 to form a fit are shown in accordance with one embodiment of the present specification. The magnets 734 are coupled to the coil 732 such that the magnets 734 are primarily located on the outer surface of the coil 732. In one embodiment, the area of ​​the coil 732 with the magnets 734 is equal to 10*a*r / 2, where a is the length of each magnet 734 and r is the radius of the circle formed by the coil 732, and the resulting fit also has the same area. In one embodiment, the circumference of the coil 732 with the magnets 734 is equal to 10*a, where a is the length of each magnet 734, and the resulting fit also has the same circumference.

[0331] Figure 7F A dodecagonal SMA coil 742 is shown, coupled to magnets 744 to form an anastomosis, according to one embodiment of the present specification. Spacers 746 are included on the coil 742 between each pair of magnets 744. In one embodiment, the spacers are included on the SMA coil to reduce the number of magnets required to obtain the desired compression force. In one embodiment, the spacers 746 are composed of a non-ferromagnetic or biocompatible material. In various embodiments, the spacers 746 include silicone or nitinol tubes or O-rings or round balls. In one embodiment, the internal angle 747 formed between adjacent magnets 744 is equal to 150°. In one embodiment, the angle 749 formed at the center of the circle formed by the coil 742 and corresponding to each magnet 744 is equal to 30°. When the coil is in its relatively straight martensitic pre-placement shape, the non-ferromagnetic spacers prevent the magnets from sticking together and prevent it from assuming a coiled austenitic post-placement shape. The size of the spacer is determined by the attractive force between the two magnets and the bending force of the nitinol coil, so that the bending force of the coil is greater than the attractive force between the ends of the magnets on the same coil, thereby allowing the coil to achieve its predetermined post-placement shape. In one embodiment, the outer diameter of the spacer ring is between 25% and 300% of the outer diameter of the magnet, and the length of the spacer ring is less than five times the length of the magnet.

[0332] Figure 7G to Figure 7K Various embodiments are shown in which the coil has a regular polygonal cross-section with equal angles and sides, where a=side length, r=inscribed circle radius (apotentiometric distance), R=circumscribed circle radius, A=area, P=perimeter, x=inner angle, y=outer angle, and n=number of sides. The side length a is described by the formula a=2r tan(π / n)=2R sin(π / n); the inscribed circle radius r is described by the formula r=(1 / 2)a cot(π / n)=R cos(π / n); the circumscribed circle radius R is described by the formula R=(1 / 2)a csc(π / n)=r sec(π / n); the area A is described by the formula A=(1 / 4)na 2 cot(π / n)=nr 2tan(π / n); the perimeter P is described by the formula P=na; the interior angle x is described by the formula x=((n-2)π / n) radians=(((n-2) / n) x 180°), and the exterior angle y is described by the formula y=(2π / n) radians=(360° / n). The shape and size of the polygon determine the shape and size of the fit. According to various embodiments of the present specification, Figure 7G A hexagonal SMA coil 752 is shown, Figure 7H An octagonal SMA coil 754 is shown, Fig.7I A decagonal SMA coil 756 is shown, Figure 7J A dodecagonal SMA coil 758 is shown, Figure 7K A tetradecagonal SMA coil 760 is shown.

[0333] Figure 8 The process of forming an anastomosis by using an SMA coil with or without a magnet is shown according to one embodiment of the present specification. As shown, a first wall 802 of a first organ and a second wall 804 of a second organ are compressed between loops of SMA wire 806 coiled in a circular shape. A circular portion 808 of tissue of the first and second organs is sandwiched between the wires 806. Due to the pressure applied by the wires 806, the blood supply 809 to the portion 808 is slowly and gradually reduced, first causing ischemia, inflammation, neovascularization and fusion of adjacent walls, followed by ischemic damage and necrosis of the tissue 808 as the pressure increases, and eventually sloughing off, leaving a circular anastomosis 810 between the first and second organ walls. In this embodiment, the slowly and gradually increasing pressure allows neovascularization to occur at the anastomotic site to ensure a healthy anastomosis.

[0334] Fig.9A The walls 902, 904 of two organs are shown compressed between loops 906, 908 of an SMA coil 900, with the compressive force provided by a combination of Nitinol wire and magnets, and the cutting surface created by the two SMA wires 906 and 908, according to one embodiment of the present specification. Fig. 9B The walls 902, 904 of two organs are shown compressed between loops of an SMA coil 900, the compression force being enhanced by the use of magnets, according to one embodiment of the present specification. Fig.9A and Fig. 9B, a wall 902 of a first organ and a wall 904 of a second organ are compressed between a first loop 906 and a second loop 908 of an SMA coil 900, which in one embodiment is a Nitinol wire coil. The pressure applied to the organ walls 902, 904 is enhanced by an attractive force 913 between magnets 910 and 912 coupled to loops 914 and 916 of the SMA coil 900, respectively. In one embodiment, a first pressure greater than 0.19 psi (10 mmHg) is applied to the tissue sandwiched between the coil loops by the combination of the coil and the magnet, and the pressure gradually increases to greater than or equal to 0.97 psi (50 mmHg), and may also increase to 145 psi (7499 mmHg), depending on the size of the magnet and the number of coils.

[0335] Fig.10 The walls 1002, 1004 of two organs are shown compressed between a loop 1006 of an SMA coil 1000 and a magnet 1008 according to one embodiment of the present specification. The wall 1002 of the first organ and the wall 1004 of the second organ are compressed between a first loop 1006 of the SMA coil 1000 and a magnet 1008 coupled to a second loop 1010 of the SMA coil. In one embodiment, the SMA coil 1000 is a Nitinol wire coil. The pressure exerted on the organ walls 1002, 1004 is enhanced by an attractive force 1013 between the magnet 1008 and another magnet 1012 coupled to another loop 1014 of the SMA coil 1000.

[0336] It is important that the magnets do not attract each other and clump together in their pre-placement shape, thereby interfering with the shape change of the SMA coil to its intended post-placement austenitic shape. Fig.11 A plurality of magnets 1104a, 1104b, 1104c, 1104d are shown coupled to a loop 1102 of an SMA coil 1100 for forming a fit in accordance with one embodiment of the present specification. The magnets 1104a-1104d are arranged around the loop 1102 of the SMA coil 1100 for forming a fit. In one embodiment, the SMA coil 1100 is made of Nitinol wire. In one embodiment, the combined length of all magnets coupled to the SMA coil is less than half the length of the SMA coil. In one embodiment, after the magnets are coupled to the coil, the magnets can slide on the coil (like beads on a necklace). In one embodiment, at least 50% of adjacent magnets on each loop of the coil (such as magnets 1104a and 1104b) are arranged with the same poles facing each other (the "S" on each magnet represents south and the "N" represents north) to create a repulsive force between two adjacent magnets in the same loop of the coil. As Fig.10 and Fig.13As shown, this configuration is ideal in situations where a fit between the nitinol wire and the magnet is desired. In various embodiments, the magnets on a single coil loop are separated by a distance less than, equal to, or greater than the length of each of two adjacent magnets.

[0337] Fig.12 A plurality of magnets 1204a, 1204b, 1204c, 1204d, 1204e, 1204f, 1204g, 1204h are shown coupled to a loop 1202 of an SMA coil 1200 for forming an anastomosis in accordance with another embodiment of the present specification. The magnets 1204a-1204h are arranged around the loop 1202 of the SMA coil 1200 for forming an anastomosis. In one embodiment, the SMA coil 1200 is made of Nitinol wire. In one embodiment, the combined length of all magnets coupled to the SMA coil is greater than or equal to 50% but less than 99% of the length of the SMA coil. In one embodiment, after the magnets 1204a-1204h are coupled to the coil loop 1202, the magnets can slide over the coil (like beads on a necklace). In one embodiment, at least 50% of adjacent magnets on each loop of the coil (such as magnets 1204a and 1204b) are arranged with the same poles facing each other ("S" on each magnet represents south and "N" represents north), thereby generating a repulsive force between two adjacent magnets in the same loop of the coil. It is important that the magnets are not clustered together so as not to significantly interfere with the function of the Nitinol Coil. It is also important that the repulsive forces between the magnets do not overwhelm the coil or significantly interfere with the function of the Nitinol Coil. In some embodiments, the axis that defines the direction of magnetic attraction between magnets on adjacent loops of the coil is perpendicular to the long axis of each magnet. In some embodiments, the axis that defines the direction of magnetic attraction between magnets on adjacent loops of the coil is perpendicular to the axis extending through the center of the coil.

[0338] Fig.13 The placement of magnets 1302, 1304, 1308, 1310 is shown coupled to adjacent loops 1306, 1312 of SMA coils for forming an anastomosis in accordance with one embodiment of the present specification. As shown, adjacent magnets 1302 and 1304 on wire loop 1306 are maintained at a distance greater than the length of each magnet. Similarly, adjacent magnets 1308 and 1310 on adjacent wire loop 1312 are maintained at a distance greater than the length of each magnet, thereby allowing magnet 1308 to slide and take up a position between magnets 1302 and 1304 such that the relative poles of magnets 1308 and 1302 are aligned. This creates pressure between the magnets on adjacent wire loops, which in turn aids in the anastomosis process, as previously described with reference to Fig.10 described.

[0339] Fig.14AAn exemplary SMA wire 1400 is shown coupled with magnets 1408, 1408a, 1408b, 1408c, 1408d to form an anastomosis prior to placement within the body in accordance with one embodiment of the present description. Fig. 14B shows an embodiment of the present specification in the intermediate placement stage and Fig.14A An exemplary SMA wire 1400 coupled to a magnet 1408 is shown. Fig. 14C The embodiment of the present invention is shown in FIG. Fig.14A The magnets 1408 are shown coupled to form an exemplary SMA wire 1400 that is fitted. Fig.14A , before placement, the SMA wire 1400 is straight and is divided into at least three sections 1402, 1404 and 1406. Sections 1402 and 1406 are coupled to a plurality of magnets 1408, 1408a, 1408b, 1408c, 1408d such that the positions of the first magnet 1408a, 1408c and the last magnet 1408b, 1408d of sections 1402 and 1404, respectively, are fixed and immovable. The remaining magnets 1408 of each section are movable / slidable in the space between the first and last magnets of each section. As shown, no magnets are provided on section 1404. Reference Fig. 14B , the SMA wire 1400 begins to coil when exposed to body heat. Fig. 14C , the SMA wire 1400 forms a tight coil that cuts through the tissue sandwiched between the coil loops, and the cutting force is further enhanced due to the attractive force between the magnets placed on the adjacent coil sections 1402 and 1406. This anastomosis mechanism is as follows Fig.9A and Fig. 9B shown.

[0340] Fig.14DAn exemplary SMA wire 1420 is shown coupled to magnets 1428, 1428a, 1428b, 1428c, 1428d to form an anastomosis before placement in the body according to another embodiment of the present specification. Before placement, the SMA wire 1420 is straight and is divided into at least three sections 1422, 1424, and 1426. Sections 1422 and 1426 are coupled to a plurality of magnets 1428, 1428a, 1428b, 1428c, 1428d such that the positions of the first magnet 1428a, 1428c and the last magnet 1428b, 1428d of sections 1422 and 1424 are fixed and immovable, respectively. The remaining magnets 1428 of each section can move / slide in the space between the first and last magnets of each section. As shown, no magnets are provided on section 1424. In addition, the first portion 1420a of the wire 1420 extending from the first end 1421 of the wire 1420 to the magnet 1428a and the second portion 1420b of the wire 1420 extending from the second end 1423 of the wire 1420 to the magnet 1428d do not contain magnets. In various embodiments, the length of the bare wire portions 1420a, 1420b is greater than or equal to half the circumference of one of the coil loops. The length of the bare wire segment in the middle of the device is also greater than or equal to Fig.14F Half the circumference of one coil loop of the depicted coil. The advantage of the bare end portion is that the SMA coil is better (more round) and more consistent (under the influence of magnetic forces) if a loop has been formed that forces the following loop to be shaped. This is a result of the inherent strain of the wire.

[0341] Fig.14E shows an embodiment of the present specification in the intermediate placement stage and Fig.14D An exemplary SMA wire 1420 coupled to a magnet 1428 is shown. Fig.14F The embodiment of the present specification shows a Fig.14D The magnets 1428 are shown coupled to form an exemplary SMA wire 1420. Fig.14E , the SMA wire 1420 begins to coil when exposed to body heat. Fig.14F , the SMA wire 1420 forms a tight coil that cuts through the tissue sandwiched between the coil loops, and the cutting force is further enhanced due to the attractive force between the magnets placed on the adjacent loop portions 1422 and 1426. This anastomosis mechanism is as follows Fig.9A and Fig. 9B shown.

[0342] Fig.15AAn exemplary SMA wire 1500 is shown coupled with magnets 1502, 1502a, 1502b to form an anastomosis prior to placement within the body in accordance with another embodiment of the present description. Fig. 15B shows an embodiment of the present specification in the intermediate placement stage and Fig.15A An exemplary SMA wire 1500 coupled to magnets 1502, 1502a, 1502b is shown. Fig. 15C The embodiment of the present invention is shown in FIG. Fig.15A The magnets 1502 are shown coupled to form an exemplary SMA wire 1500 that is fitted. Fig.15A , before placement, the SMA wire 1500 is straight and coupled to the plurality of magnets 1502, 1502a, 1502b such that the positions of the first magnet 1502a and the last magnet 1502b in the series of magnets 1502 are fixed and immovable. The remaining magnets 1502 are movable / slidable in the space between the first and last magnets 1502a, 1502b. Fig. 15B , the SMA wire 1500 begins to coil when exposed to body heat. Fig. 15C , the SMA wire 1500 forms a tight coil that cuts through the tissue sandwiched between the coil loops, and the cutting force is further enhanced due to the attractive force between the magnets 1502 placed on adjacent loops of the coil 1500. Fig.10 In some embodiments, the two cutting surfaces can be provided by two magnets, as shown in FIG17. In some embodiments, the movement of the magnets 1502a and 1502b can be limited by stops at the ends, thereby preventing the end magnets from sliding off the SMA coil.

[0343] Fig.15DAn exemplary SMA wire 1520 is shown coupled to magnets 1522, 1522a, 1522b to form an anastomosis prior to placement in the body according to yet another embodiment of the present specification. Prior to placement, the SMA wire 1520 is straight and coupled to a plurality of magnets 1522, 1522a, 1522b such that the positions of the first magnet 1522a and the last magnet 1522b in the series of magnets 1502 are fixed and immovable. The remaining magnets 1522 can move / slide in the space between the first and last magnets 1522a, 1522b. The first portion 1520a of the wire 1520 extending from the first end 1521 of the wire 1520 to the magnet 1522a and the second portion 1520b of the wire 1520 extending from the second end 1523 of the wire 1520 to the magnet 1522d do not contain magnets. In various embodiments, the length of the bare wire portions 1520a, 1520b is greater than or equal to half the circumference of one of the coil loops. The length of the bare wire segment in the middle of the device is also greater than or equal to Fig.15F Half the circumference of one of the coil loops of the depicted coil. The advantage of the bare end portion is that the SMA coil is better (more round) and more consistent (under the influence of magnetic forces) if a loop has been formed which forces the following loop to be shaped. This is a result of the inherent strain of the wire.

[0344] Fig.15E shows an embodiment of the present specification in the intermediate placement stage and Fig.15D An exemplary SMA wire 1520 coupled to magnets 1522, 1522a, 1522b is shown. Fig.15F The embodiment of the present invention is shown in FIG. Fig.15D The magnets 1522 are shown coupled to form an exemplary SMA wire 1520 that is fitted. Fig.15E , the SMA wire 1520 begins to coil when exposed to body heat. Fig.15F , the SMA wire 1520 forms a tight coil that cuts through the tissue sandwiched between the coil loops, and the cutting force is further enhanced due to the attractive force between the magnets 1522 placed on adjacent loops of the coil 1502. Fig.9A and Fig. 9B In some embodiments, the two cutting surfaces can be provided by two magnets, such as Fig.17A In some embodiments, the movement of magnets 1522a and 1522b is limited by end stops, thereby preventing the end magnets from sliding off the SMA coil.

[0345] Figure 15Gis a graph showing the pressure 1511 exerted by the loop of the coil on body tissue as the distance 1517 between the magnets on the coil decreases according to one embodiment of the present specification. The first curve 1510 represents the pressure exerted by the coil having N52 neodymium magnets. The second curve 1512 represents the pressure exerted by the coil having N40 neodymium magnets. The pressure 1511 exerted by the coil loop represented by the two curves 1510, 1512 increases as the distance 1517 between the magnets decreases, particularly at distances less than 2 mm. At distances greater than or equal to 5 mm, the anastomotic device causes blockage of capillary blood flow without blocking arterial or venous blood flow, causes low-grade inflammation and fibrosis, and causes fusion between the walls of two adjacent organs. Once the distance 1517 becomes 1 mm or less, the pressure applied by the curves 1510, 1512 is greater than the arterial occlusion pressure 1513 and the venous occlusion pressure 1515, as depicted by points 1510a and 1512a on the curves 1510 and 1512, respectively. Thus, once the distance 1517 is 1 mm or less, the pressure 1511 applied by the loops of the coils is large enough to cause occlusion of all blood vessels in the body tissue sandwiched between the loops, thereby causing ischemic damage, tissue necrosis, and resulting in the formation of an anastomosis whose size approaches that of the nitinol loop. The slow increase in pressure on the tissue allows for new blood vessel formation, fusion of adjacent tissue walls, and the formation of a healthy anastomosis without the anastomotic leaks common in surgical anastomosis.

[0346] Fig.16A An exemplary circular SMA coil 1602 for forming an anastomosis is shown in accordance with one embodiment of the present specification. The coil 1602 includes a plurality of circular loops 1604. Fig. 16B An exemplary circular SMA coil 1606 is shown with a cutting edge 1610 for forming a stapling, according to one embodiment of the present specification. The coil 1606 includes a plurality of circular rings 1608. One of the rings 1608 is provided with a pointed / sharp cutting edge 1610 for cutting tissue compressed between the coil rings. Fig. 16C An exemplary square SMA coil 1612 for forming an anastomosis is shown in accordance with one embodiment of the present specification. The coil 1612 includes a plurality of square rings 1614. The sharp edges of the square rings provide a cutting surface.

[0347] Fig.17A An exemplary device 1700 is shown that includes circular magnets 1702 coupled to SMA coils for forming anastomoses, in accordance with one embodiment of the present specification. Each circular magnet 1702 is coupled to a coil ring 1704 for forming anastomoses when placed in vivo. Fig. 17BAn exemplary device 1705 according to one embodiment of the present specification is shown, which includes circular magnets 1706 coupled to SMA coils for anastomosis, wherein at least one magnet includes a cutting edge 1710. As shown, each circular magnet 1706 is coupled to a coil loop 1708 for forming anastomosis when placed in the body. At least one of the magnets 1706 is provided with a pointed / sharp protrusion 1710, which is designed to interlock with the other magnets / coil loops and enhance the cutting of tissue compressed between the coil loop and the magnet.

[0348] Fig. 17C An exemplary device 1711 according to one embodiment of the present specification is shown, which includes a square magnet 1712 coupled to an SMA coil with a serrated edge for forming a fit. The square magnet 1712 is arranged around a coil ring 1714 with a serrated edge to prevent the magnet 1712 from rotating. In one embodiment, as Fig. 17C As shown, the magnets 1712 are arranged so that the edges 1716 of the magnets slide over each other as the SMA wire changes shape and coils and is further enhanced by the attractive force between the magnetic surfaces, thereby generating a cutting action / force.

[0349] Fig.17D An exemplary device 1721 is shown, according to one embodiment of the present specification, comprising square magnets 1718 coupled to SMA coils for forming anastomoses. Each square magnet 1718 is coupled to a coil ring 1720 for forming anastomoses when placed in vivo. Fig.17E An exemplary device 1725 according to one embodiment of the present specification is shown, which includes square magnets 1722 coupled to an SMA coil for forming an anastomosis, wherein at least one magnet includes a cutting edge 1726. As shown, each square magnet 1722 is coupled to a coil loop 1724 for forming an anastomosis when placed in the body. At least one of the magnets 1722 is provided with a pointed / sharp protrusion 1726, which is designed to interlock with the other magnets / coil loops and enhance the cutting of tissue compressed between the coil loop and the magnet.

[0350] Fig.17F A cross-sectional view of an exemplary device 1729 according to one embodiment of the present specification is shown, the device comprising circular magnets 1728 coupled to SMA coils for forming anastomosis, wherein the magnets 1728 include convex edges 1732. Each circular magnet 1728 is coupled to a coil ring 1730 for forming anastomosis when placed in the body. The magnets 1728 are provided with convex edges 1732, which are designed to interlock with other magnets / coil rings and enhance the cutting of tissue compressed between the coil ring and the magnet. Figure 17GA cross-sectional view of an exemplary device 1735 is shown, according to one embodiment of the present specification, comprising square magnets 1734 coupled to SMA coils for forming anastomoses, wherein the magnets include convex edges 1738. Each square magnet 1734 is coupled to a coil loop 1736 for forming anastomoses when placed in vivo. Magnets 1734 are provided with convex edges 1738 designed to interlock with other magnets / coil loops and enhance cutting of tissue compressed between the coil loop and the magnet.

[0351] Fig.18A and Fig.18B A plurality of magnets 1802, 1803 are shown arranged around a ring 1804 of SMA coils 1800, 1801 for forming a mating connection in accordance with an embodiment of the present specification. The magnets 1802, 1803 are arranged equidistantly around the ring 1804 of the SMA wire coil so that the relative poles of adjacent magnets are facing each other, thereby generating a repulsive force that holds the magnets 1802, 1803 fixed in a predetermined position on the ring 1804. Therefore, the magnets 1802, 1803 do not gather together on the ring 1804. In one embodiment, as shown in FIG. Fig.18A As shown, the magnet 1802 is provided with a ring 1806, and the ring 1804 passes through the ring for coupling the magnet 1802 with the ring 1804. In another embodiment, as shown in FIG. Fig.18B As shown, magnet 1802 is coupled to ring 1804, wherein magnet 1803 comprises a hollow conduit (not shown) through which ring 1804 passes. In other embodiments, the magnet is coupled to the ring in any suitable manner, wherein the magnet can slide freely along the ring.

[0352] Fig.18C and Fig.18D 1 shows a plurality of magnets 1810, 1807 arranged around a ring 1812 of conforming SMA coils 1811, 1813 separated by non-ferromagnetic spacers 1814, in accordance with one embodiment of the present specification. Fig.18CAs shown, the ring 1808 of magnet 1810 passes through SMA coil ring 1812. Magnet 1810 is arranged so that the relative poles of adjacent magnets are opposite, thereby generating an attractive force. As shown, a spacer 1814 made of non-ferromagnetic material is placed between magnets 1810 to keep magnet 1810 fixed in a predetermined position on ring 1812, thereby ensuring that magnet 1810 does not gather together on ring 1812 and interfere with the shape change from martensite shape to austenite shape. In various embodiments, spacer 1814 includes silicone, Teflon, PTFE or nitinol tube, O-ring or ball. In another embodiment, spacer 1814 only includes air, wherein each spacer 1814 is produced by gluing or fixing each magnet 1810, 1807 to coil 1811, 1813, so that each magnet 1810, 1807 is positioned at a predetermined distance from the next or previous magnet. In some embodiments, the predetermined distance between adjacent magnets on the same loop of the coil is in the range of 1 / 128 inch to 1 inch. In other embodiments, the predetermined distance between adjacent magnets on the same loop of the coil is in the range of 0.1 mm to 1 cm. In some embodiments, the minimum predetermined distance is defined as the distance between adjacent magnets on the same loop of the coil being sufficient to ensure that the magnets do not physically interfere with the formation of the coil loop to any significant extent. In some embodiments, the minimum predetermined distance is defined as the distance between adjacent magnets on the same loop of the coil being sufficient to ensure that the magnets do not physically contact each other before the coil loop is fully formed. In some embodiments, the maximum predetermined distance between adjacent magnets on the same loop of the coil is no more than 10 times the length of the magnet. In another embodiment, the maximum predetermined distance between adjacent magnets on the same loop of the coil is less than 50% of the circumference of the coil. Reference Fig.18D , the magnet 1807 of the coil 1813 comprises a hollow conduit through which the coil ring 1812 passes. As shown, a spacer 1814 made of a non-ferromagnetic material is placed between the magnets 1807 to ensure that the magnets 1807 do not gather together on the ring 1812.

[0353] Fig.18EAn arrangement of magnets 1820, 1820a, 1820b around a ring 1824 of an SMA coil 1821 for forming an anastomosis is shown according to one embodiment of the present specification. Magnet 1820 is arranged around the ring 1824 of the SMA coil 1821 by an annulus 1822. Magnets 1826 of adjacent rings 1828 are positioned near and between the poles of magnets 1820a and 1820b of the ring 1824 by magnetic attraction. Magnet 1826 acts as a locking magnet, thereby locking each of magnets 1820a and 1820b in a corresponding fixed position on the coil ring 1824 forming a lasso. This forms a fixed ring that can be used to draw the walls of adjacent organs closer during placement. The locking mechanism also prevents the ring from accidentally slipping out of the organ during placement.

[0354] Fig.18F Another arrangement of magnets 1830, 1830a, 1830b around a ring 1834 of an SMA coil 1835 for forming an anastomosis according to one embodiment of the present specification is shown. Magnets 1830 are arranged around the ring 1834 of the SMA coil 1835. Magnets 1836 of adjacent rings 1838 are positioned near and between the poles of magnets 1830a and 1830b of the ring 1834 by magnetic attraction. Magnets 1836 serve as locking magnets, thereby locking each of magnets 1830a and 1830b in a corresponding fixed position on the coil ring 1834. This forms a fixed ring that can be used to pull the walls of adjacent organs closer during placement. As described above, the locking mechanism also prevents the ring from accidentally slipping out of the organ during placement. As shown, spacers 1840 made of non-ferromagnetic material are also placed between magnets 1830, thereby ensuring that magnets 1830 do not gather together on the ring 1834. In various embodiments, the spacer 1840 comprises silicone, Teflon, PTFE, or Nitinol tubing.

[0355] Fig.19A , Fig.19B and Fig.19C The steps of forming an anastomosis between two organs in a human body are shown according to one embodiment of the present specification. In order to form an anastomosis between a pancreatic pseudocyst 1902 and a stomach 1901 wall, first, the stomach or duodenal wall adjacent to the pseudocyst wall is identified by endoscope 1906. Using endoscope 1906, a hollow needle or catheter 1910 having a lumen for carrying an SMA wire 1912 is delivered to the identified location, where the SMA wire can be coupled to a magnet 1914. The needle or catheter 1910 is used to pierce the organ wall and deliver the SMA wire 1912 therein. During placement, the SMA wire 1912 passes through the lumen of the needle or catheter 1910 until approximately 1 / 2 of the wire is placed in the pseudocyst 1902 along with the magnet 1914. As shown in FIG. Fig.18E and Fig.18FAs described in , adjacent loops of wire in a pseudocyst can be attracted together, and the loop can be used to pull the pseudocyst wall near the stomach wall. Then, the needle or catheter 1910 is retracted into the stomach 1901 together with the endoscope 1906, and the remaining 1 / 2 of the wire 1912 and the magnet 1914 are placed so that a portion of the wire is left in the pseudocyst and the stomach, respectively. When exposed to body heat, the straight SMA wire 1912 is coiled up and the adjacent organs (pseudocyst 1902 and stomach 1901) are compressed together, and the loop of the coil 1912 slowly cuts the walls of the adjacent organs to form anastomosis as described above. The compression force can be provided by the coil alone or in combination with the magnet. Once the coil 1912 completely cuts the two walls forming a stable anastomosis 1920, the coil 1912 falls off naturally and passes through the body naturally, or can be retrieved using an endoscope or any other minimally invasive technique.

[0356] Fig. 20A A non-ablative needle 2002 for delivering an SMA coil 2006 in vivo is shown according to one embodiment of the present specification. The non-ablative hollow needle 2002 includes a lumen 2004 in which an SMA stapling coil 2006 is placed for endoscopic placement into the human body. Fig. 20B Shows Fig. 20A The handle of the non-ablative needle is shown. The tip portion 2020 engages the endoscope. Knob 2021 controls the length of the catheter that can be moved in and out of the endoscope tip. Knob 2022 controls the length of the needle that can be withdrawn from the catheter shaft at the needle tip. Port 24 allows cold saline to be pushed into the needle lumen to help keep the coil in its martensitic shape and also accommodates a pusher catheter to push the coil out of the needle.

[0357] Fig.21A cautery needle device 2100 for delivering an SMA coil 2104 in vivo through an endoscope is shown according to one embodiment of the present specification. The cautery needle device 2100 includes a port 2108, a body 2110, a handle 2106, a distal tip 2112, a needle 2102, and an electrosurgical attachment 2107, and is used to deliver an SMA stapling coil 2104 into a human body through an endoscope. The body 2110 of the needle device 2100 is inserted into a human body through an instrument channel of an endoscope so that the distal tip 2112 extends from the distal end of the endoscope. The needle 2102 extends from the distal tip 2112 of the device 2100 through the operating handle 2106 for piercing a predetermined organ wall. The needle device 2100 includes a port 2108 for injecting cold saline into the needle lumen to help keep the coil in a martensitic shape and introduce a push catheter. The SMA coil 2104 is delivered through the puncture site by a pusher catheter inserted into the port 2108, and the coil 2104 is pushed out of the tip 2112 of the needle device 2100 and into the punctured organ wall. Optionally, in one embodiment, the device 2100 includes a balloon 2103 located at its distal tip 2112 for positioning the tip 2112 so that the two lumens are close to each other and assist in the placement of the coil 2104. A marker or stop mechanism is built into the pusher tube for evaluating the number of coils pushed out of the catheter.

[0358] Fig. 22A cautery needle device 2200 according to one embodiment of the present specification is shown, which is used to deliver an SMA coil 2204 in vivo via an endoscope with the help of a guide wire 2206. A cautery needle device 2200 includes a handle 2208, a body 2212, a first port 2210 for cold saline infusion, a second port 2214 for guide wire passage, a distal tip 2221, a needle 2202, and an electrosurgical attachment 2207, which is used to deliver an SMA stapling coil 2204 into the human body via an endoscope with the help of a guide wire 2206. The body 2212 of the needle device 2200 is inserted into the human body via the channel of the endoscope so that the distal tip 2221 extends from the distal end of the endoscope. The needle 2202 extends from the distal tip 2221 by operating the handle 2208 to pierce the target tissue. Electrocautery is used to assist puncture. The guide wire 2206 is inserted into the body 2212 of the needle device 2200 through the second port 2214 and extends from the distal tip 2221 into the punctured organ for maintaining position / pathway to guide the catheter tip 2221 and the SMA coil 2204 to be placed in a predetermined position. The SMA coil 2204 is delivered to the lumen pierced by the needle 2202 by a push catheter, which is introduced via the first port 2210 and pushes a portion of the coil 2204 from the distal tip 2221 into the lumen of the second organ. The tip 2221 is retracted into the lumen of the first organ and the remaining coil is placed. The coil then changes shape and fixes the two walls of the two organs together, fuses the two walls, and then cuts a predetermined shape and size of the anastomosis.

[0359] Fig.23A A mechanism for releasing an SMA coil 2304 from a delivery catheter 2300 is shown according to one embodiment of the present specification. A coil coupling member 2302 at the end of the SMA coil 2304 to be placed is attached to a delivery coupling member 2306 on a pusher element 2308 to move the coil 2304 in and out of a delivery catheter sheath 2310. In some embodiments, the coil coupling member 2302 includes a coil loop and the delivery coupling member 2306 includes a delivery loop. In various embodiments, one or both of the coil coupling member 2302 and the delivery coupling member 2306 can be configured between a first open configuration and a second closed configuration. A handle 2312 is provided for pushing in or out the pusher element 2308. Fig. 23B An embodiment according to the present specification is shown. Fig.23A The delivery catheter 2300 is shown releasing the SMA coil 2304. The handle 2312 is pushed forward while holding the sheath 2310. As shown, when the coil 2304 is pushed out of the catheter sheath 2310, the delivery coupling member 2306 on the advancement element 2308 or the coil 2304 or both open, causing the coil 2304 to be disengaged from the advancement element 2308 and the catheter 2300.

[0360] Fig.24A A mechanism for releasing an SMA coil 2404 from a delivery catheter 2400 is shown according to another embodiment of the present specification. A coil coupling member 2402 at the end of the SMA coil 2404 to be placed is attached to a delivery coupling member 2406 on a propulsion element 2408 to move the coil 2404 into and out of a delivery catheter sheath 2410. In some embodiments, the coil coupling member 2402 includes a coil loop and the delivery coupling member 2406 includes a delivery articulated grasper. In various embodiments, one or both of the coil coupling member 2402 and the delivery coupling member 2406 can be configured between a first open configuration and a second closed configuration. A handle 2412 is provided for pushing in or out the propulsion element 2408. Fig. 24B An embodiment according to the present specification is shown. Fig.24A The delivery catheter 2400 is shown releasing the SMA coil 2404. The handle 2412 is pushed forward while holding the sheath 2410. As shown, when the coil 2404 is pushed out of the catheter sheath 2410, the delivery coupling member 2406 on the pusher element 2408 opens, allowing the coil 2404 to be disengaged from the pusher element 2408 and the catheter 2400. In one embodiment, the pusher element 2408 includes a marking to alert the user when a portion (less than the entire length) of the coil 2404 has been released from the catheter 2410. In another embodiment, the pusher element 2408 includes a stop mechanism to prevent the user from inadvertently placing the entire length of the coil 2404 from the catheter 2410 at any time.

[0361] Fig.2525 is a flow chart showing steps for forming an anastomosis using an anastomosis device according to one embodiment of the present specification. In step 2502, to form an anastomosis between a first organ and a second organ, first, adjacent walls of the two organs are identified through an endoscope. Next, in step 2504, an SMA wire that can be coupled to a magnet is delivered to the identified location. In one embodiment, an SMA coil is delivered through a hollow needle or catheter using an endoscope, the hollow needle or catheter having an inner lumen for carrying the SMA wire, and the SMA wire can be coupled to the magnet. In step 2506, the identified organ wall is pierced, and a portion of the SMA wire is placed in the inner lumen of the first organ, while the remaining coil is placed in the inner lumen of the second organ. In step 2508, when exposed to body heat, the relatively straight SMA wire coils into its predetermined austenitic shape and compresses the adjacent organs together. In step 2510, the loops of the coil and / or magnets (if included) together slowly cut the walls of two adjacent organs to form an anastomosis over a period of time, with the compressive force being enhanced by the attractive force between the magnets located on adjacent loops of the SMA coil. As the loops of the coil and / or magnets cut the walls of the two organs, the attractive force increases over time, thereby bringing the magnets closer to each other. In step 2512, once the coil has completely cut the two organ walls to form a stable anastomosis, the coil naturally falls off and passes through the body naturally, or can be retrieved using an endoscope or any other minimally invasive technique. In some embodiments, the coil is specially shaped to facilitate its passage in a specific direction.

[0362] Fig.26A , Fig.26B and Fig.26C A first view, a second view, and a third view of an exemplary device 2600 for forming an anastomosis in a relatively straight pre-coiled configuration according to an embodiment of the present specification are shown, respectively. The device includes a shape memory alloy (SMA) wire 2602 having a plurality of magnets 2604 and spacers 2606 coaxially positioned around the wire 2602. In one embodiment, the wire 2602 is composed of Nitinol. In one embodiment, the spacers 2606 are composed of a non-ferromagnetic material. In various embodiments, the spacers 2606 include silicone, Teflon, PTFE, or Nitinol tubes or O-rings or round balls. In various embodiments, each magnet 2604 is separated from an adjacent magnet 2604 by a set of spacers 2606. In one embodiment, each set of spacers 2606 includes three spacers 2606. FIG. 26A to FIG. 26C Device 2600 is depicted in a pre-coiled or pre-placement configuration. Device 2600 has a curved shape when not constrained by a delivery catheter and at room temperature. When constrained in a delivery catheter, device 2600 is nearly straight (e.g., Fig.15A 1500 in FIG. 1 ).

[0363] Fig.26D and Fig.26E The coiled configuration is shown Fig.26A 2600 for forming anastomosis. After placement, when exposed to body temperature, the SMA wire coils to move the device 2600 from FIG. 26A to FIG. 26C The bending configuration shown moves to Fig.26D and Fig.26E The coiled configuration shown. Spacers 2606 ensure that magnets 2604 do not bunch together on device 2600. Fig.26D , the magnetic attraction between the magnets 2604 on adjacent rings 2607a, 2607b, 2607c of the winding device, for example, the magnetic attraction between the magnets 2604a, 2604b, 2604c on adjacent rings 2607a, 2607b, 2607c, is used to pull the rings 2607a, 2607b, 2607c closer to tighten the coil.

[0364] Fig.26F A first exemplary device 2610 for forming an anastomosis is shown in a post-placement conical coil configuration according to one embodiment of the present specification. The device 2610 is configured to pass through tissue in only one direction after the anastomosis is formed. The device 2610 includes a single shape memory wire that, once placed, assumes the shape of a coil 2613. The device 2610 includes a loop 2618 at a first end 2611 of the coil 2613, the loop 2618 having a larger diameter than a loop 2619 at an opposite second end 2612 of the coil 2613. The diameter of the cutting loops 2618, 2619 of the coil 2613 determines the diameter of the anastomosis. Therefore, the resulting anastomosis will also have a conical or funnel shape, with a larger opening at a first end associated with the first end 2611 of the coil 2613 and a smaller opening at a second end associated with the second end 2612 of the coil 2613. Once the anastomosis is formed, the device 2610 will only be able to pass through the anastomosis in the direction indicated by arrow 2614 because the first end 2611 is too large to pass through the anastomotic opening formed by the ring 2619 and the device end 2612.

[0365] Figure 26GA second exemplary device 2620 for forming anastomosis is shown in a post-placement conical coil configuration according to one embodiment of the present specification. The device 2620 is configured to pass through tissue in only one direction after the anastomosis is formed. The device 2620 includes a plurality of magnets 2625 separated by a plurality of spacers 2626 positioned on a shape memory wire. The device 2620 includes a ring 2628 at a first end 2621 of the device 2620, the ring 2628 having a larger diameter than a ring 2629 at an opposite second end 2622 of the device 2620. The diameter of the cutting rings 2628, 2629 of the device 2620 determines the diameter of the anastomosis. Thus, the resulting anastomosis will also have a conical or funnel shape, with a larger opening at a first end associated with the first end 2621 of the device 2620 and a smaller opening at a second end associated with the second end 2622 of the device 2620. Once the anastomosis is formed, the device 2620 will only be able to pass through the anastomosis in the direction indicated by arrow 2624 because the first end 2621 is too large to pass through the anastomotic opening formed by the ring 2629 and the device end 2622.

[0366] Fig.26H An embodiment of a device 2630 for forming an anastomosis is shown in a post-placement coil configuration, the device comprising a single flange 2637 attached to one end 2631 of a coil 2633. The device 2630 comprises a coil 2633 having a first end 2631 and an opposing second end 2632, and comprising a plurality of magnets 2635 separated by a plurality of spacers 2636 positioned on a shape memory wire. In one embodiment, the diameter of the first end 2631 of the coil 2633 is equal to the diameter of the second end 2632 of the coil 2633. The device 2630 also comprises an extension or flange 2637 having a first end 2638 and a second end 2639. In one embodiment, the flange 2637 is tapered. The second end 2639 of the flange 2637 is attached to the first end 2631 of the coil 2633. The diameter of the first end 2638 of the flange 2637 is larger than the diameter of the second end 2639 of the flange 2637, and larger than the diameters of the two ends 2631, 2632 of the coil 2633. Once the anastomosis is formed, the device 2630 will only pass in the direction indicated by the arrow 2634 (the direction including the end of the flange) because the relatively large diameter of the first end 2638 of the flange 2637 will prevent the flange 2637 from passing through the anastomosis formed by the relatively small diameter of the coil 2633.

[0367] Fig.26I and Fig.26JAn end view and a side view of another embodiment of a device 2640 for forming an anastomosis are shown in a coil configuration after placement, respectively, the device including a single flange 2647 attached to one end 2641 of a coil 2643. The device 2640 includes a coil 2643 having a first end 2641 and an opposing second end 2642, and including a plurality of magnets 2645 separated by a plurality of spacers 2646 positioned on a shape memory wire. In one embodiment, the diameter of the first end 2641 of the coil 2643 is equal to the diameter of the second end 2642 of the coil 2643. The device 2640 also includes a star-shaped or flower-shaped extension or flange 2647 attached to the first end 2641 of the coil 2643. In one embodiment, the flange 2647 includes a cautery piercing member 2649 configured to receive an electrical current to generate heat and pierce tissue to deliver the device 2640. The cautery piercing member 2649 is attached to one end of the flange 2647 by a threaded connection. The opposite end of the flange 2647 includes another threaded connection for attaching the flange 2647 to the coil 2643. The flange 2647 includes a plurality of angled protrusions 2648 extending outward from the center of the device 2640, with the diameter defined by the outer edges of the protrusions 2648 being larger than the diameter of the two ends 2641, 2642 of the coil 2643. Once the anastomosis is formed, the device 2640 will only pass in the direction indicated by the arrow 2644 (including the end direction of the flange) because the relatively large diameter defined by the outer edges of the protrusions 2648 of the flange 2647 will prevent the flange 2647 from passing through the anastomosis formed by the relatively small diameter of the coil 2643.

[0368] Figure 26KAn embodiment of a device 2650 for forming an anastomosis in a coil configuration after placement is shown, the device including flanges 2657, 2667 attached to each end of a coil 2653. The device 2650 includes a coil 2653 having a first end 2651 and an opposing second end 2652, and includes a plurality of magnets 2655 separated by a plurality of spacers 2656 positioned on a shape memory wire. In one embodiment, the diameter of the first end 2651 of the coil 2653 is equal to the diameter of the second end 2652 of the coil 2653. The device 2650 also includes a first extension or flange 2657 and a second extension or flange 2667, which have a first end 2661, 2671 and a second end 2662, 2672, respectively. In one embodiment, each flange 2657, 2667 is tapered. The second end 2662 of the first flange 2657 is attached to the first end 2651 of the coil 2653, and the second end 2672 of the second flange 2667 is attached to the second end 2652 of the coil. The first end 2661, 2671 of each flange 2657, 2667 has a respective diameter that is greater than the diameter of each second end 2662, 2672 of the flanges 2657, 2667, and greater than the diameter of both ends 2651, 2652 of the coil 2653. Once the anastomosis is formed, the device 2650 will be fixed within the anastomosis and cannot pass because the relatively large diameter of the first ends 2661, 2671 of the flanges 2657, 2667 will prevent the device 2650 from passing through the anastomosis formed by the relatively small diameter of the coil 2653 in either direction. In this configuration, the diameter of the coil 2653 is smaller than the flanges 2657, 2667 at both ends, and after the anastomosis is formed, the coil 2653 will not spontaneously pass through the anastomosis because the flanges 2657, 2667 will get stuck.

[0369] Figure 26L , Figure 26M and Fig.26NAn end view and a side view of another embodiment of a device 2680 for forming an anastomosis in a coil configuration after placement are shown, the device including flanges 2687, 2697 attached to each end of a coil 2683. The device 2680 includes a coil 2683 having a first end 2681 and an opposing second end 2682, and including a plurality of magnets 2685 separated by a plurality of spacers 2686 positioned on a shape memory wire. In one embodiment, the diameter of the first end 2681 of the coil 2683 is equal to the diameter of the second end 2682 of the coil 2683. The device 2680 also includes a first star-shaped or flower-shaped extension or flange 2687 attached to the first end 2681 of the coil 2683, and a second star-shaped or flower-shaped extension or flange 2697 attached to the second end 2682 of the coil 2683. In one embodiment, one or each flange 2687, 2697 includes a cautery piercing member 2689 configured to receive an electrical current to generate heat and pierce tissue to deliver the device 2680. The cautery piercing member 2689 is attached to the end of one or each flange 2687, 2697 by a threaded connection. The opposite end of each flange 2687, 2697 includes another threaded connection for attaching the flange 2687, 2697 to the coil 2683. The flanges 2687, 2697 each include a plurality of angled protrusions 2688, 2698 extending outwardly from the center of the device 2680 such that the diameter defined by the outer edges of the protrusions 2688, 2698 is greater than the diameter of the two ends 2681, 2682 of the coil 2683. Once the anastomosis is formed, the device 2680 will be fixed within the anastomosis and cannot pass because the relatively large diameter defined by the protrusions 2688, 2698 of the flanges 2687, 2697 will prevent the device 2680 from passing in either direction through the anastomosis formed by the relatively small diameter of the coil 2683. After the anastomosis is formed, the coil 2680 will not pass spontaneously.

[0370] Fig.26O shows the method for manufacturing a Figure 26L The mold 2690 of the stapling device 2680 with a flange. The mold 2690 includes a first plurality of pins 2691 and a second plurality of pins 2692 extending vertically from a base 2693 of the mold 2690. The first plurality of pins 2691 are located at a first distance 2695 from a center 2694 of the mold 2693, and the second plurality of pins 2692 are located at a second distance 2696 from the center 2694 of the mold 2693, wherein the second distance 2696 is greater than the first distance 2695. Also refer to FIG. 26L to FIG. 26O, the diameter defined by the first plurality of pins 2691 corresponds to the diameter of the coil 2683, and the diameter defined by the second plurality of pins 2692 corresponds to the diameter defined by the outer edges of the protrusions 2688, 2698 of the flanges 2687, 2697. The coil 2683 of the anastomotic device 2680 is wound around the first plurality of pins 2691 so that the coil 2683 has a coil shape. Each flange 2687, 2697 is wound around a first pin 2691f of the first plurality of pins 2691, then around an adjacent first pin 2692f of the second plurality of pins 2692, then around an adjacent second pin 2691s of the first plurality of pins 2691, then around an adjacent second pin 2692s of the second plurality of pins 2692, and so on, forming a star-shaped or flower-shaped flange in a clockwise direction (or, in another embodiment, in a counterclockwise direction).

[0371] Fig. 27 An SMA coil device 2702 for forming an anastomosis with a delivery catheter 2706 is shown in a pre-placement configuration according to one embodiment of the present specification. A cautery ring 2704 formed at the distal end of the SMA coil 2702 device is used to pierce the target tissue and cauterize the tissue when forming the anastomotic opening. The pusher delivery catheter 2706 pushes the coil 2702 out of the distal end of the catheter 2706. The SMA coil device 2702 includes a magnet 2710 that enables the coil to change shape and secure the two walls of the two organs together. The SMA coil device 2702 is attached to a ring / articulated grasper 2712 on the pusher element 2714 of the delivery catheter 2706 to move the coil device 2702 in and out of the delivery catheter sheath 2716. A handle 2718 is provided for pushing in or pushing out the pusher element 2714. In one embodiment, an electrosurgical unit connector 2720 provides electrical contact with the electrosurgical generator for the pusher element 2714 and the SMA coil device 2702.

[0372] Fig.28An SMA coil device 2800 for forming anastomosis with a delivery catheter 2820 in a pre-placement configuration according to another embodiment of the present specification is shown. The SMA coil device 2800 includes a cautery ring 2804 formed at the distal end of an SMA wire 2802 and a plurality of magnets 2806 and a spacer 2808 coaxially positioned around the SMA wire 2802. The cautery ring 2804 is used to pierce the target tissue and cauterize the tissue when forming the anastomotic opening. In one embodiment, the SMA wire 2802 is composed of nitinol. In one embodiment, the spacer 2808 is composed of a non-ferromagnetic material. In various embodiments, the spacer 2808 includes a silicone or nitinol tube or an O-ring or a round ball. The ring 2810 at the proximal end of the SMA wire 2802 is attached to a ring / articulated grasper 2812 on a pusher element 2814 to move the SMA wire 2802 into and out of the delivery catheter sheath 2816 of the delivery catheter 2820. In one embodiment, the SMA wire 2802 includes an insulating covering 2803. In various embodiments, the insulating covering 2803 is composed of silicone or Teflon. When the cautery ring 2804 is heated via an electric current delivered to the SMA wire 2802 through the pusher element 2814 and the ring / articulated grasper 2812, the insulating covering 2803 prevents the body of the SMA wire from transferring heat to the magnet 2806 and the spacer 2808. The SMA wire 2802 and the delivery catheter sheath 2816 are disposed within an outer catheter 2818 at the distal end of the delivery catheter 2820.

[0373] Fig.29A A cautery tip 2902 is shown for placement with an anastomosis coil device according to various embodiments of the present specification. The cautery tip 2902 is configured to receive thermal energy from an electric current source. When the cautery tip heats up, it is advanced into body tissue. The thermal energy passes through the target tissue, creating an opening for forming an anastomosis, while cauterizing and preventing blood loss from the tissue surrounding the newly formed opening. Fig.29BAn anastomotic coil device 2900 is shown according to one embodiment of the present specification, which is provided with a cautery tip 2902 in a pre-placement configuration. The anastomotic coil device 2904 is removably connected to a pusher 2907 including a cautery wire 2906 by a threaded connector 2908 at the proximal end of the anastomotic coil device 2904, thereby creating an electrical connection between the pusher 2907 with the cautery wire 2906 and the anastomotic coil device 2904. The anastomotic coil device 2900 includes an inner SMA wire 2904 having a plurality of magnets 2910 and a spacer 2912 coaxially positioned therearound. In one embodiment, the SMA wire 2904 is composed of nitinol. The SMA wire 2904 extends distally through the lumen 2903 of the cautery tip 2902. A metal cylinder 2916 is located at the distal end of the lumen 2903 of the cautery tip 2902. The SMA wire 2904 further extends distally through the lumen 2905 of the metal cylinder 2916. A rivet 2914 connects the metal cylinder 2916 to the SMA wire 2904 at the distal end of the cautery tip 2902. An additional wire 2918 is connected to the rivet 2914 and, in various embodiments, extends along the outer surface of the cautery tip 2902. Electric current is provided through the cautery wire 2906 and through the threaded connector 2908, along the SMA wire 2904, to the metal cylinder 2916 and the wire 2918. The electric current generates thermal energy in the metal cylinder 2916 and the wire 2918, which is transferred to the cautery tip 2902, which, in various embodiments, is composed of ceramic or PEEK. The thermal energy heats the cautery tip 2902, which is used to puncture and cauterize tissue to create an opening for anastomosis formation. After the anastomotic coil device 2900 is placed, the pusher 2907 with the cautery wire 2906 is disconnected from the SMA wire 2904 .

[0374] Fig. 30AA side cross-sectional view of an anastomotic coil device 3000 according to one embodiment of the present specification is shown, the anastomotic coil device having a distal cauterization tip 3002 in a pre-placement configuration. In one embodiment, the cauterization tip 3002 includes a ceramic "hot head" coupled to a cauterization electrode 3004. The ceramic hot head design enables the catheter to pierce the organ wall. In one embodiment, the length of the ceramic head 3002 and the cauterization electrode 3004 is approximately 7.4 mm. A stainless steel support wire 3008 and a clamping tube 3010 couple the cauterization tip 3002 to a nitinol wire 3012. A plurality of magnets 3014 and spacers 3016 are coaxially positioned around the nitinol wire 3012. In one embodiment, the nitinol wire 3012 is encapsulated in an insulating PTFE, Teflon or silicone sleeve 3018. The stainless steel wire 3008 couples the nitinol wire 3012 to the cauterization tip 3002, and the proximal stopper 3022 attached to the proximal end of the nitinol wire 3012 is detachably coupled to the steel pusher catheter 3020. Electric current passes from the pusher catheter 3020 through the nitinol wire 3012 and the stainless steel wire 3008, into the cauterization tip 3002 and the electrode 3004, heating the cauterization tip 3002 to electrocauterize and puncture the target tissue.

[0375] Fig. 30B Shows Fig. 30A 3030. In one embodiment, the diameters of the nitinol wire 3012 and each magnet 3014 are approximately 0.5 mm and 2.5 mm, respectively, and the length and diameter of the proximal stop 3022 are approximately 4 mm and 1.5 mm, respectively. Fig. 30C Shows Fig. 30A Magnified view of the portion marked 3040 in FIG. 1. In one embodiment, each magnet 3014 is approximately 2.5 mm in length.

[0376] Fig.30D Shows that there is Fig. 30A Another view of a cautery-capable stapling coil device showing a cautery tip. The cautery tip 3002 is coupled to a nitinol wire (not visible) covered with a magnet 3014 and a spacer 3016 via a support wire 3008. Fig.30E Shows Fig. 30A An enlarged view of the coupling of the proximal stop 3022 of the anastomotic coil device and the pusher catheter 3020 is shown. The proximal stop 3022 is removably coupled to the steel pusher catheter 3020, which allows current to pass through the Nitinol wire all the way to the cautery tip.

[0377] Fig.30F Shown with Fig. 30A A close up view of the cautery tip 3002 coupled to the cautery electrode 3004 of the anastomotic coil device is shown. Figure 30G Shows Fig.30FA front view of a cautery tip 3002 is shown. As shown, the cautery tip 3002 has a substantially circular cross-section with a circular opening 3006 in the center for receiving the cautery electrode 3004. Fig. 30H Shows Fig.30F A side cross-sectional view of the cautery tip 3002 and the cautery electrode 3004 is shown in FIG. Fig. 30I Shows Fig.30F The cautery electrode 3004 is shown. As shown, the electrode 3004 is substantially cylindrical and is mounted in a circular opening 3006 at the distal end of the cautery tip 3002. In one embodiment, a support wire 3008 forms a loop at the distal end of the cautery tip 3002 and helps to secure the electrode 3004 in place and facilitates electrocautery puncture of an organ. Current flows through the wire 3008 to heat the electrode 3004. The heat energy is transferred to the cautery tip 3002, which then punctures and cauterizes the target tissue to create an opening for forming an anastomosis.

[0378] Fig.31A A three-lumen catheter for delivering an anastomotic coil device according to one embodiment of the present specification is shown: the first lumen 3101 is used to carry the anastomotic coil device, the second lumen 3103 is used to carry a guide wire, and the third lumen 3105 is used to optionally carry a cautery wire for puncturing an organ. Fig.31B A side cross-sectional view of a stapling coil device 3100 and a guide wire 3110 encapsulated in a catheter 3108 for delivering the stapling coil device 3100 in a pre-placement configuration according to an embodiment of the present specification is shown. As shown, a plurality of magnets 3102 and spacers 3104 are coaxially positioned around an SMA wire 3106. In one embodiment, the wire 3106 is comprised of nitinol. In one embodiment, the spacer 3104 is comprised of a non-ferromagnetic material. In various embodiments, the spacer 3104 comprises a silicone or nitinol tube or an O-ring or a round ball. A stop mechanism 3118 is coupled to both ends of the wire 3106. In an embodiment, after the magnets 3102 and the spacer 3104 are assembled along the wire 3106, the stop mechanisms 3118 are riveted or crimped to both ends of the wire 3106. In one embodiment, the length of each stop mechanism 3118 is 1 mm. Similar to Fig.31A In the depicted triple lumen catheter, the catheter 3108 delivers the anastomotic coil device 3100 through the first lumen of the catheter 3108, and the guide wire 3110 for guiding the placement of the anastomotic coil device 3100 at a predetermined position in the body is located in the second lumen of the catheter 3108. The anastomotic coil device 3100 is pushed out of the catheter 3108 by the pusher tube 3114. The cautery wire (not shown) can optionally be passed through the third lumen or keyhole ( Fig.31A The inner cavity 3105 in the anastomosis coil device 3100 is used to heat the distal end of the anastomosis coil device 3100 to facilitate puncture and cauterization of the target tissue. Fig.31C Shown along Fig.31B 31. As shown in the figure, the first lumen 3101 for the anastomotic coil device, the second lumen 3103 for the guide wire, and the third lumen or keyhole 3105 for the cautery wire all have circular cross-sections. In one embodiment, the diameter of the third lumen or keyhole 3105 is about 0.60 mm, the diameter of the second lumen 3103 is about 0.60 mm, and the diameter of the first lumen 3101 is about 2.2 mm. Fig.31D Shown along Fig.31B A cross-sectional view of the BB axis is shown. In one embodiment, the diameter of the pusher tube 3114 is approximately 2 mm and the diameter of the catheter 3108 is approximately 3.5 mm. Fig.31E The catheter 3108 and Fig.31B Another view of a guidewire for delivering an anastomotic coil device. As shown, the catheter 3108 partially encapsulates a guidewire 3110 and a connector 3116 for connecting to a monopolar endoscopic cable, which is disposed in a third lumen or keyhole ( Fig.31C In one embodiment, the guide wire 3110 has a diameter of about 0.5 mm and the connector 3116 has a diameter of about 0.5 mm.

[0379] Fig.32A A cross-sectional view of an anastomotic coil device 3200 in a pre-placement configuration disposed in a delivery catheter 3208 according to another embodiment of the present specification is shown. As shown, the anastomotic coil device 3200 includes a plurality of magnets 3202 and a spacer 3204 coaxially positioned around an SMA wire 3206. In one embodiment, the wire 3206 is composed of nitinol. In one embodiment, the spacer 3204 is composed of a non-ferromagnetic material. In various embodiments, the spacer 3204 includes a silicone or nitinol tube or an O-ring or a round ball. The catheter 3208, which is made of PEEK or Teflon in some embodiments, encapsulates the anastomotic coil device 3200 and is coupled to a conductor head 3210 at the distal end, which, in some embodiments, is made of ceramic or PEEK for puncturing an organ by electrocautery. As shown, at the proximal end, the anastomotic coil device 3200 is coupled to a pusher tube 3212. Stop mechanisms 3216 are applied to both ends of the wire 3206 to prevent the magnet 3202 and the spacer 3204 from sliding off the wire 3206. In an embodiment, the stop mechanisms 3216 are crimped or riveted to both ends of the wire 3206 after the magnet 3202 and the spacer 3204 are assembled along the stent. The riveted or crimped stop mechanisms 3216 at the proximal end are detachably coupled to the pusher tube 3212, allowing the stapling coil device 3200 to be released from the catheter 3208. In an embodiment, the length of each stop mechanism 3216 is 1.5 mm. Fig.32B Shown along Fig.32A 32. As shown in the figure, the outer catheter 3208 and the conductor head 3210 have a circular cross-section and a diameter of approximately 3.3 mm and 2.2 mm, respectively. In addition, the wire 3214 runs through the length of the catheter 3208 and is located near the conductor head 3210. The current supplied to the wire 3214 is converted into heat energy in the conductor head 3210, which helps the conductor head 3210 to electrocauterize and puncture the target tissue to form anastomosis. Fig.32C Shown along Fig.32A 32. The cross-sectional view of the CC axis is shown. As shown, the wire 3206 and each magnet 3202 have a circular cross-section. In one embodiment, the diameter of each magnet 3202 is 2 mm, and the diameter of the first lumen 3201 containing the stapling coil device is 2.2 mm. The wire 3214 is depicted as extending through the second lumen 3203 in the wall of the catheter 3208. Fig.32D Shown along Fig.32A DD axis cross-sectional view shown. As shown, in one embodiment, the pusher tube 3212 has a circular diameter of approximately 1.9 mm and is disposed within the first lumen 3201. Additionally, in one embodiment, the guide wire 3214 has a circular cross-section and a diameter of approximately 0.25 mm and is disposed within the second lumen 3203, which in one embodiment has a diameter of 0.30 mm.

[0380] Fig.32E Shows Fig.32A An enlarged view of the conductor head 3210 is shown. Fig.32E As shown, the outer conduit 3208 partially encloses the wire 3214 and the conductor head 3210. In one embodiment, the wire 3214 is welded to the conductor head 3210. In one embodiment, the conductor head has a cylindrical portion 3220 with a flange 3222, which is about 2.5 mm long and protrudes around the circular portion as shown. In one embodiment, the inner diameter and outer diameter of the conductor head 3210 are approximately 2.2 mm and 2.4 mm, respectively. Fig.32F Shows Fig.32A The anastomotic coil device 3200 is shown in a post-placement configuration after delivery in vivo. As shown, after delivery, the wire 3206 is coiled, trapping body tissue within the wire turns and magnets 3202 to form an anastomosis. Figure 32G Shows Fig.32F A cross-sectional view of anastomotic coil device 3200 is shown. In one embodiment, the diameter of wire 3206 is 0.4 mm. In the post-placement configuration of device 3200, magnets 3202 are shown aligned along similar planes. Fig.32H shows that it is used as Fig.32BThe o-ring of the spacer 3204 is shown. In one embodiment, the outer diameter of the o-ring is about 2.2 mm and the diameter of the inner circular opening 3209 is about 0.6 mm.

[0381] Fig.33A A dual handle delivery device 3300 is shown for delivering a stapling coil device 3308 having a cauterizing tip 3318, according to one embodiment of the present specification. As shown, the dual handle delivery device 3300 includes a first handle 3302 coupled to an outer catheter 3306. The device 3300 also includes a second handle 3310 coupled to an inner catheter 3312. The second handle 3310 includes an electrosurgical unit connector 3316 in electrical communication with the inner catheter 3312 for delivering current to the cauterizing tip 3318 of the stapling coil device 3308. The stapling coil device 3308 having the cauterizing tip 3318 is located within the inner catheter 3312. The first handle 3302 and the second handle 3310 are manipulated relative to each other to place the stapling coil device 3308. Fig.33B Shows Fig.33A An enlarged view of the second handle 3310 and electrosurgical connector 3316 is shown.

[0382] Fig.34A A cross-sectional view of a dual-handle delivery device 3400 is shown for delivering an anastomotic coil device having a cauterizing tip 3402 according to one embodiment of the present specification. The anastomotic coil device including the cauterizing tip portion 3402 is delivered through the distal end of the delivery device 3400, which also includes a handle portion 3406 at the proximal end for pushing the anastomotic coil device out of the distal end of the delivery device 3400. Fig.34B Shows Fig.34A An enlarged cross-sectional view of the tip portion 3402 is shown. The tip portion 3402 includes a ceramic head 3408 that encapsulates a cauterization electrode 3410. A guide wire 3412 passes through the proximal end of the ceramic head 3408 until it extends from the distal end of the ceramic head 3408 adjacent to the cauterization electrode 3410. In one embodiment, the guide wire 3412 has a diameter of approximately 0.025 inches. The ceramic head 3408 partially covers a guide wire support 3414 that is encapsulated within an inner tube 3416 made of a PEEK material. In one embodiment, the guide wire support 3414 has a diameter of approximately 0.89 mm. In one embodiment, the guide wire 3412 is coupled to the ceramic head 3408 by a UV glue. In one embodiment, the inner tube 3416 is coupled to the guide wire support 3414 by using a UV glue. Fig.34C Shows Fig.34B A cross-sectional view of the tip portion 3402 is shown. As shown, the ceramic head 3408, the guide wire 3412, the guide wire support 3414 and the inner tube 3416 have circular cross-sections.

[0383] In one embodiment, the cautery tip 3402 is a monopolar cautery tip to facilitate puncturing an organ such as the intestinal wall. In one embodiment, a catheter carrying an anastomotic coil device is placed in the intestinal tract of a patient using therapeutic endoscopic ultrasound (EUS). Under ultrasound guidance, the cautery tip is used for transmural puncture through the stomach wall into the adjacent small intestine or gallbladder cavity. In another embodiment, a small enterotomy is made near the mesenteric edge of the patient's jejunal loop, and a catheter carrying an anastomotic coil device is passed through the intestinal lumen into the lumen of the adjacent jejunal loop or stomach.

[0384] Fig.34D Shows Fig.34A An enlarged cross-sectional view of the guidewire portion 3404 is shown. Fig.34E Shows Fig.34D A cross-sectional view of the guidewire portion 3404 is shown. Fig.34D and Fig.34E The guide wire support 3414 is encapsulated in the inner tube 3416, and the inner tube is surrounded by a double-lumen tube 3418 made of PEEK material. The guide wire 3412 passes through one lumen of the double-lumen tube 3418, and the guide wire support 3414 passes through the other lumen of the double-lumen tube 3418. Fig.34E The double lumen tube 3418 is partially enclosed by an outer tube 3420, which in one embodiment is made of a braided mesh material.

[0385] Fig.34F Shows Fig.34A FIG. 34 is an enlarged cross-sectional view of the handle portion 3406 shown in FIG. The handle portion 3406 includes a conductive plug / pin 3422 and a transparent knob tail 3424. The conductive plug / pin 3422 is electrically connected to the guide wire 3412 for providing electrical contact to the guide wire 3412. Fig.34B Electrode 3410 delivers current.

[0386] Fig.3535 is a flowchart showing steps for forming anastomosis by using magnetic compression force between a shape memory wire and adjacent organs or structures according to one embodiment of the present specification. In step 3502, to form anastomosis between a first organ and a second organ, first, an endoscope is placed into the lumen of the first organ. In step 3504, an adjacent second organ is identified using endoscopy, fluoroscopy, or ultrasound imaging techniques. In 3506, the walls of the first and second organs are pierced by using a catheter passing through or beside the endoscope to reach the lumen of the second organ. In step 3508, a portion of the shape memory wire including a magnet is placed in the lumen of the second organ, and the wire is transformed from a straight shape to a coiled shape. In step 3510, the catheter is pulled back into the lumen of the first organ, the remaining portion of the shape memory wire including a magnet is placed in the lumen of the first organ, and the wire is transformed from a straight shape to a coiled shape. In step 3512, the adjacent walls of the first and second organs are compressed due to the compression force generated by the coil, and the compression force increases over time to cause a compression anastomosis.

[0387] Fig.36 3602, to form an anastomosis between a first organ and a second organ, first, an endoscope is placed in the lumen of the first organ to inflate the lumen with a gas or fluid and allow the gas or fluid to flow into the lumen of the adjacent second organ. In step 3604, the adjacent second organ is identified using endoscopic or ultrasound imaging techniques, wherein the gas or fluid facilitates identification. In 3606, the walls of the first and second organs are pierced by using a catheter passing through or beside the endoscope to reach the lumen of the second organ. In step 3608, a portion of a shape memory wire including a magnet is placed in the lumen of the second organ, and the wire is transformed from a straight shape to a coiled shape. In step 3610, the catheter is pulled back into the lumen of the first organ, the remaining portion of the shape memory wire including a magnet is placed in the lumen of the first organ, and the wire is transformed from a straight shape to a coiled shape. At step 3612, adjacent walls of the first and second organs are compressed due to the compressive force generated by the coils, which increases over time to induce a compressed anastomosis.

[0388] Fig.373702 is a flowchart showing steps for forming anastomosis by using magnetic compression force between a shape memory wire and adjacent organs or structures according to one embodiment of the present specification. In step 3702, in order to form anastomosis between a first organ and a second organ, first, an endoscope is placed into the lumen of the first organ. In step 3704, an adjacent second organ is identified using endoscopic examination or ultrasound imaging technology. In 3706, the walls of the first and second organs are pierced by using a catheter passing through or beside the endoscope to reach the lumen of the second organ. In step 3708, a portion of the shape memory wire including a magnet is placed in the lumen of the second organ, and the wire is transformed from a straight shape to a coiled shape. In step 3710, the catheter is pulled back into the lumen of the first organ, the remaining portion of the shape memory wire including a magnet is placed in the lumen of the first organ, and the wire is transformed from a straight shape to a coiled shape. In step 3712, the adjacent walls of the first and second organs are compressed due to the compression force generated by the coil, and the compression force increases over time to cause a compression anastomosis. In step 3714, once the anastomosis is formed, the shape memory coil falls off naturally and is naturally excreted from the body.

[0389] Fig.38 3802 is a flowchart showing the steps of forming an anastomosis by using a shape memory coil with a magnet between adjacent organs according to an embodiment of the present specification. In step 3802, to form an anastomosis between a first organ and a second organ, first, an endoscope is placed in the lumen of the first organ to inflate the lumen with a gas or a fluid and allow the gas or fluid to flow into the lumen of the adjacent second organ. In step 3804, the adjacent second organ is identified using endoscopic examination or ultrasound imaging technology, wherein the gas or fluid helps to identify. In 3806, the walls of the first and second organs are pierced by using a catheter passing through or beside the endoscope to reach the lumen of the second organ. In step 3808, a portion of the shape memory wire including the magnet is placed in the lumen of the second organ, and the wire is transformed from a straight shape to a coiled shape. In step 3810, the catheter is pulled back into the lumen of the first organ, the remaining portion of the shape memory wire including the magnet is placed in the lumen of the first organ, and the wire is transformed from a straight shape to a coiled shape. At step 3812, the adjacent walls of the first and second organs are compressed due to the compression force generated by the coil, which increases over time to cause a compressed anastomosis. At step 3814, once the anastomosis is formed, the shape memory coil remains in the anastomosis until it is removed from the body through an endoscope.

[0390] Fig.39AAn exemplary magnet 3902 for use with a device for forming anastomosis according to one embodiment of the present specification is shown. As shown, the force 3904 generated by the magnet 3902 and measured between the two cylindrical outer surfaces 3902a, 3902b of the magnet 3902 is approximately 1.185 N. In various embodiments, the length, inner diameter, and outer diameter of the magnet 3902 are 2.5 mm, 1.0 mm, and 2.5 mm, respectively. Fig.39B An exemplary magnet 3906 for use with a device for forming an anastomosis according to another embodiment of the present specification is shown. As shown, the force 3908 generated by the magnet 3906 and measured between the two cylindrical outer surfaces 3906a, 3906b of the magnet 3906 is approximately 2.318N. In various embodiments, the length, inner diameter, and outer diameter of the magnet 3906 are 3mm, 0.66mm, and 3mm, respectively. The force ratio between the cylindrical surfaces 3906a, 3906b of the magnet 3906 is Fig.39A The force between the cylindrical surfaces 3902a, 3902b of magnet 3902 is approximately 191% greater.

[0391] As described above, the coil structure of the anastomotic device of the present specification allows the application of multiple magnetic layers (or coil rings), thereby increasing the compressive force on the tissue surface without increasing the complexity of the medical procedure. The magnetic anastomotic device is easily separated due to the gastrointestinal force. The possibility of separation defined by the distance between the coils of the coiled device depends on the size of the magnet, the number of coils or rings in the device, and the radius of the coil. Since the embodiment of the anastomotic device of the present specification includes multiple coil rings on both sides of the formed anastomosis, the possibility of coil ring separation is less than that of a single ring, a separate and physically separated device of the prior art. In addition, since the embodiment of the present specification includes a single integrated device, if the first magnetic element on the first coil ring is attached to the second magnetic element on the second coil ring, the two magnetic elements are separated, the separation will only be temporary, and the two magnetic elements will automatically reattach to the target tissue area without manual intervention. In other words, the magnetic coil rings cannot move away from each other because they are attached to a single device and they will eventually reconnect due to magnetic force.

[0392] The following is an example of the effect of magnet size, number of coil loops, and coil radius on the distance between coil loops of the magnetic stapling device placed in the present specification and the resulting possibility of stapling separation (separation of two adjacent tissues). In operation, the device having a plurality of magnets fixed in relationship is positioned near a tissue wall through an endoscope; the tissue wall is pierced with the device, and a first group of the plurality of magnets passes through the wall, while a second group of the plurality of magnets does not pass through the tissue wall, thereby leaving a portion of the plurality of magnets on one side of the tissue wall and a portion of the plurality of magnets on the other side of the tissue wall; after the first group of the plurality of magnets forms at least one coil and the second group of the plurality of magnets forms at least one second coil (occurs automatically without further manual intervention), a period of time is required. When forming the coils, the first group and the second group of the plurality of magnets (each magnet having a diameter in the range of 1 mm to 4 mm, preferably 2 mm to 3 mm) attract each other and automatically move toward each other, thereby compressing a tissue wall of approximately 10 mm to 15 mm thick to 2 mm to 8 mm thick depending on the type of target tissue.

[0393] In the following examples, magnets with a maximum diameter of 3 mm are used to accommodate endoscopic delivery. In other embodiments, the anastomotic devices of the present specification have a maximum diameter of 7 mm. In some embodiments, the magnets are N52 magnets, and each magnet has a surface magnetic field in the range of 10,000 to 20,000 Gauss, preferably 14800 Gauss. In addition, several assumptions are made about the magnetic device, the human anatomy, and the forces generated by the device and the anatomy:

[0394] Assume that the standard cumulative thickness of the two walls to be anastomosed is 8-10 mm.

[0395] The ideal magnetic force for anastomosis formation is 0.1-0.3N, and the ideal pressure for anastomosis formation is 14.5-58psi (0.1-0.4MPa), but the pressure applied by the disclosed device ranges from 1-145psi (0.007-1MPa).

[0396] The average cumulative stress in the human stomach during the 30 minutes before gastric emptying is 160,000 ± 70,000 dynes / cm 2 (0.016±0.007MPa) and feeding 520,000±270,000dynes / cm 2 (0.052±0.027MPa).

[0397] The small intestine is capable of generating pressures greater than 1.93 psi (100 mmHg; 0.013 MPa).

[0398] The average thickness of normal stomach wall is 5.1±1.1mm, and the maximum thickness is 7mm.

[0399] The average thickness of normal small intestine wall is as follows:

[0400] o Duodenum: 1.53±0.58mm

[0401] o Jejunum: 1.50±0.55mm

[0402] o Ileum: 1.61±0.47mm

[0403] The average thickness of normal gallbladder wall is 2.6±1.6mm, and the maximum thickness is 4mm.

[0404] The average thickness of gallstones is 0.4±1.4 mm.

[0405] The average thickness of gallbladder sludge was 0.5±1.4 mm.

[0406] The average wall thickness of the gallbladder in acute cholecystitis is 3.1±1.6 mm.

[0407] The average thickness of the common bile duct wall was 0.8±0.4mm.

[0408] Examples 1: Device with one coil loop on each side of the anastomosis

[0409] Fig.39C is a graph showing the relationship between compression pressure and the distance between coil loops provided by a stapling device having a single coil loop on each side of an anastomosis to be formed, according to one embodiment of the present specification. In other words, Fig.39C Each device in comprises a total of one pair of coil loops, i.e., a single coil loop is included on each side of the anastomosis to be formed. Curves 3910, 3911, and 3912 show the relationship between pressure and distance between coil loops for devices having 1 pair of coil loops, an internal coil radius of 10 mm, and a magnet width or diameter of 2.0 mm, 2.5 mm, and 3.0 mm, respectively. It is assumed that normal peristalsis of the gastrointestinal tract is capable of generating a maximum gastric pressure 3913 of approximately 7.25 psi (0.05 MPa) and a maximum small intestinal pressure 3914 of approximately 1.88 psi (0.013 MPa). As Fig.39C As shown, the pressure (P) generated by the anastomotic device increases as the distance (d) between the coil loops decreases. In addition, the pressure generated increases as the width of the magnet increases. For example, curve 3912 shows a pressure of approximately 7.25 psi (0.05 MPa) at a distance of approximately 0.36 cm for a device including a magnet with a width of 3.0 mm, while curve 3910 shows a pressure of approximately 3.63 psi (0.025 MPa) at the same distance for a device including a magnet with a width of 2.0 mm.

[0410] To form a gastric anastomosis, a device comprising magnets with a diameter of 2 mm or 3 mm needs to achieve a distance of no more than 2 mm to 4 mm between the rings (between the magnets), respectively, so that gastric pressure cannot separate the rings. To form a smaller intestinal anastomosis, a device comprising magnets with a diameter of 2 mm or 3 mm needs to achieve a distance of no more than 6 mm to 8 mm between the rings (between the magnets), respectively, so that small intestinal pressure cannot separate the rings. It is assumed that the cumulative thickness of the organ wall is greater than 10 mm.

[0411] As the distance between the coil loops increases, the pressure generated by the device decreases and the risk of anastomotic separation increases. Fig.39C The distance at which the gastric anastomosis formed by the device shown in FIG. 39 is at risk of separation. When each curve 3910, 3911, 3912 is below the assumed maximum gastric pressure 3913, each gastric anastomosis is at risk of separation. That is, under the influence of gastric pressure, the gastric anastomosis formed by the device shown in FIG. Fig.39C Each gastric anastomosis formed by the device shown is at risk of separation within a distance of at least 0.36 cm to 1 cm. Box 3916 depicts Fig.39C The distance at which the small intestinal anastomosis formed by the device shown has a risk of separation. When each curve 3910, 3911, 3912 is below the assumed maximum small intestinal pressure 3914, each small intestinal anastomosis has a risk of separation. That is, under the influence of the small intestinal pressure, Fig.39C Each small intestinal anastomosis formed by the device shown is at risk of separation within a distance range of at least 0.8 cm to 1 cm. Therefore, assuming that the magnet diameter is 3.0 mm and the spacing is less than 3.6 mm, gastric peristalsis is insufficient to separate and / or move the magnet. Assuming that the magnet diameter is 3.0 mm and the spacing is less than 8 mm, small intestinal peristalsis is insufficient to separate and / or move the magnet. As previously described, the single device structure of the anastomotic device of the present specification allows them to automatically reconnect in the correct orientation when separation occurs. Because the devices of the prior art require two separate devices to form the anastomosis, these devices are at risk of spontaneous separation at the distances represented by boxes 3915 and 3916, and will not reconnect, thereby causing displacement.

[0412] Examples 2: Device with two coil loops on each side of the anastomosis

[0413] Fig.39D is a graph showing the relationship between compression pressure and the distance between coil loops provided by an anastomotic device having two coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification. In other words, Fig.39DEach device represented in comprises a total of two pairs of coil loops, each pair of coil loops comprising a single coil loop on each side of the anastomosis to be formed, for a total of 4 coil loops. Curves 3920, 3921 and 3922 show the relationship between pressure and distance between coil loops for devices having 2 pairs of coil loops, an internal coil radius of 10 mm and a magnet width or diameter of 2.0 mm, 2.5 mm and 3.0 mm, respectively. It is assumed that normal peristalsis of the gastrointestinal tract is capable of producing a maximum gastric pressure 3923 of approximately 7.25 psi (0.05 MPa) and a maximum small intestinal pressure 3924 of approximately 1.88 psi (0.013 MPa). As Fig.39D As shown, the pressure (P) generated by the anastomotic device increases as the distance (d) between the coil rings decreases. In addition, the pressure generated increases as the width of the magnet increases. For example, curve 3922 shows a pressure of about 7.25psi (0.05MPa) at a distance of about 0.55cm for a device including a magnet with a width of 3.0mm, while curve 3920 shows a pressure of about 3.63psi (0.025MPa) at the same distance for a device including a magnet with a width of 2.0mm. In order to form a gastric anastomosis, a device including a 2mm to 3mm magnet will need to reach a distance of no more than 3.5mm to 6mm between the rings (between the magnets) so that the gastric pressure cannot separate the rings. In order to form a small intestinal anastomosis, a device including a 2.5mm to 3mm magnet cannot be separated by the small intestinal pressure, while a device including a 2mm magnet will need to reach a distance of no more than 8mm between the rings (between the magnets) so that the small intestinal pressure cannot separate the rings. Assume that the cumulative thickness of the organ wall is greater than 10mm.

[0414] As the distance between the coil loops increases, the pressure generated by the device decreases and the risk of anastomotic separation increases. Fig.39C The distance at which the gastric anastomosis formed by the device shown in FIG. 39 is at risk of separation. When each curve 3920, 3921, 3922 is below the assumed maximum gastric pressure 3923, each gastric anastomosis is at risk of separation. That is, under the influence of gastric pressure, the distance at which the gastric anastomosis formed by the device shown in FIG. 39 is at risk of separation. Fig.39D Each gastric anastomosis formed by the device shown is at risk of separation within a distance of at least 0.54 cm to 1 cm. Box 3926 depicts Fig.39DThe distance at which the small intestinal anastomosis formed by the devices shown is at risk of separation. Curves 3921 and 3922 represent devices with magnets having diameters of 2.5 mm and 3 mm, respectively, which do not extend below the assumed maximum small intestinal pressure 3924, and therefore, these devices will not experience separation. When curve 3920 is below the assumed maximum small intestinal pressure 3914, the small intestinal anastomosis formed by the device with a magnet having a diameter of 2.0 mm is at risk of separation. That is, under the influence of small intestinal pressure, the small intestinal anastomosis formed by the device with a magnet having a diameter of 2.0 mm is at risk of separation at a distance of 0.8 cm to 1 cm. Therefore, assuming that the magnet diameter is 3.0 mm and the spacing is less than 5.4 mm, gastric peristalsis is insufficient to separate and / or move the magnet. Assuming that the magnet diameter is 3.0 mm, the normal amount of small intestinal peristalsis is insufficient to separate and / or move the magnet. Therefore, for Fig.39D For all devices shown, increasing the number of coil pairs from 1 to 2 reduces the risk of separation of the anastomosis at greater distances. As previously described, the single device structure of the anastomosis devices of the present specification allows them to automatically reconnect in the correct orientation when separation occurs. Because the devices of the prior art require two separate devices to form an anastomosis, these devices are at risk of spontaneous separation at the distances represented by boxes 3925 and 3926 and will not reconnect, resulting in displacement.

[0415] Example 3: Device with three coil loops on each side of the anastomosis

[0416] Fig.39E is a graph showing the relationship between compression pressure and the distance between coil loops provided by an anastomotic device having three coil loops on each side of an anastomosis to be formed according to one embodiment of the present specification. In other words, Fig.39E Each device represented in comprises a total of three pairs of coil loops, each pair of coil loops comprising a single coil loop on each side of the anastomosis to be formed, for a total of 6 coil loops. Curves 3930, 3931 and 3932 show the relationship between pressure and distance between coil loops for devices having 3 pairs of coil loops, an internal coil radius of 10 mm, and a magnet width or diameter of 2.0 mm, 2.5 mm and 3.0 mm, respectively. It is assumed that normal peristalsis of the gastrointestinal tract is capable of producing a maximum gastric pressure 3933 of approximately 7.25 psi (0.05 MPa) and a maximum small intestinal pressure 3934 of approximately 1.88 psi (0.013 MPa). As Fig.39EAs shown, the pressure (P) generated by the anastomotic device increases as the distance (d) between the coil rings decreases. In addition, the pressure generated increases as the width of the magnet increases. For example, curve 3932 shows a pressure of about 7.25psi (0.05MPa) at a distance of about 0.65cm for a device including a magnet of 3.0mm in width, while curve 3930 shows a pressure of about 3.63psi (0.025MPa) at the same distance for a device including a magnet of 2.0mm in width. In order to form a gastric anastomosis, a device including a 2mm to 3mm magnet will need to reach a distance of no more than 4mm to 7mm between the rings (between the magnets) so that the gastric pressure cannot separate the rings. Additional forces from the coil and self-alignment features can further prevent the coil from separating. Fig.39E All devices represented in, including magnets of 2.0 mm, 2.5 mm, and 3 mm diameter, cannot be divided by small intestinal pressure. It is assumed that the cumulative thickness of the organ wall is greater than 10 mm.

[0417] As the distance between the coil loops increases, the pressure generated by the device decreases and the risk of anastomotic separation increases. Fig.39E The distance at which the gastric anastomosis formed by the device shown in FIG. 39 is at risk of separation. When each curve 3930, 3931, 3932 is below the assumed maximum gastric pressure 3933, each gastric anastomosis is at risk of separation. That is, under the influence of gastric pressure, the distance at which the gastric anastomosis formed by the device shown in FIG. 39 is at risk of separation. Fig.39E Each gastric anastomosis formed by the devices shown is at risk of separation over a distance of at least 0.65 cm to 1 cm. No device is at risk of separation due to small intestinal pressure. Therefore, assuming a magnet diameter of 3.0 mm and a spacing of less than 6.5 mm, gastric motility is insufficient to separate and / or move the magnet. Assuming a magnet diameter of 3.0 mm, normal small intestinal motility is insufficient to separate and / or move the magnet. Therefore, for Fig.39E For all devices shown, increasing the number of coil pairs from 1 to 3 reduces the risk of separation of the anastomosis at greater distances. As previously described, the single device structure of the anastomotic devices of the present specification allows them to automatically reconnect in the correct orientation when separation occurs. Because the devices of the prior art require two separate devices to form an anastomosis, these devices are at risk of spontaneous separation at the distance represented by box 3935 and will not reconnect, thereby causing displacement.

[0418] Example 4: Device with 2.0 mm diameter magnet and different number of coil loops on each side of the anastomosis

[0419] Fig.39F and Figure 39GGraphs showing the relationship between the compression pressure and the distance between the coil loops and the relationship between the force and the distance between the coil loops provided by an anastomotic device having a magnet with a diameter of 2.0 mm and having a different number of coil loops on each side of the anastomosis to be formed, respectively, according to an embodiment of the present specification. Fig.39F and Figure 39G As shown, both pressure (P) and force (F) increase as the distance (d) between the coil loops decreases. Curves 3940 and 3950 represent a device with a magnet of 2.0 in width or diameter, an internal coil radius of 10 mm, and a pair of coil loops (1 coil on each side of the anastomosis to be formed). Curves 3941 and 3951 represent a device with a magnet of 2.0 in width or diameter, an internal coil radius of 10 mm, and two pairs of coil loops (2 coils on each side of the anastomosis to be formed). Curves 3942 and 3952 represent a device with a magnet of 2.0 in width or diameter, an internal coil radius of 10 mm, and three pairs of coil loops (3 coils on each side of the anastomosis to be formed). Curves 3943 and 3953 represent a device with a magnet of 2.0 in width or diameter, an internal coil radius of 10 mm, and four pairs of coil loops (4 coils on each side of the anastomosis to be formed). Increasing the number of coil loop pairs increases the pressure and force generated by the device at the same distance. For example, a device with four coil loop pairs represented by curves 3943, 3953 produces a pressure of about 11.6 psi (0.08 MPa) and a force of about 16 N at a distance of about 0.6 cm between the coil loops, while a device with only one coil loop pair represented by curves 3940, 3950 produces a pressure of about 2.9 psi (0.02 MPa) and a force of about 4 N at the same distance. Fig.39F , once by Fig.39F The pressures generated by the devices shown fall below an assumed maximum gastric pressure 3944, and spontaneous separation of gastric anastomoses formed by all of these devices can occur within the range of 0.8 to 1.0 cm distance between the coil loops, as depicted by box 3946. Only the devices with 1 pair of coil loops are susceptible to small bowel anastomotic separation, as depicted by curve 3940, falling below an assumed maximum small bowel pressure 3945. Therefore, assuming that the 4 pair coil device contains magnets with a diameter of 2.0 mm and are spaced less than 8 mm apart, gastric peristalsis is insufficient to separate and / or move the magnets. Assuming that the 4 pair coil device contains magnets with a diameter of 2.0 mm, the amount of normal small bowel peristalsis is insufficient to separate and / or move the magnets.

[0420] Example 5: Device with 2.5 mm diameter magnet and different number of coil loops on each side of the anastomosis

[0421] Fig.39H and Fig.39IGraphs showing the relationship between the compression pressure and the distance between the coil loops and the relationship between the force and the distance between the coil loops provided by an anastomotic device having a magnet with a diameter of 2.5 mm and having a different number of coil loops on each side of the anastomosis to be formed, respectively, according to an embodiment of the present specification. Fig.39H and Fig.39I As shown, both pressure (P) and force (F) increase as the distance (d) between the coil loops decreases. Curves 3960 and 3970 represent a device with a magnet of 2.5 in width or diameter, an internal coil radius of 10 mm, and a pair of coil loops (1 coil on each side of the anastomosis to be formed). Curves 3961 and 3971 represent a device with a magnet of 2.5 in width or diameter, an internal coil radius of 10 mm, and two pairs of coil loops (2 coils on each side of the anastomosis to be formed). Curves 3962 and 3972 represent a device with a magnet of 2.5 in width or diameter, an internal coil radius of 10 mm, and three pairs of coil loops (3 coils on each side of the anastomosis to be formed). Curves 3963 and 3973 represent a device with a magnet of 2.5 in width or diameter, an internal coil radius of 10 mm, and four pairs of coil loops (4 coils on each side of the anastomosis to be formed). Increasing the number of coil loop pairs increases the pressure and force generated by the device at the same distance. For example, a device with four coil loop pairs represented by curves 3963, 3973 generates a pressure of about 11.6 psi (0.08 MPa) and a force of about 16 N at a distance of about 0.6 cm between the coil loops, while a device with only one coil loop pair represented by curves 3960, 3970 generates a pressure of about 2.9 psi (0.02 MPa) and a force of about 4 N at the same distance. Fig.39H , once by Fig.39H The pressures generated by the devices shown fall below an assumed maximum gastric pressure 3964, and spontaneous separation of gastric anastomoses formed by all of these devices may occur within the range of 0.8 to 1.0 cm distance between the coil loops, as depicted by box 3966. Only the devices with 1 pair of coil loops are susceptible to small bowel anastomotic separation, as depicted by curve 3960, falling below an assumed maximum small bowel pressure 3965. Therefore, assuming that the 4 pair coil device contains magnets with a diameter of 2.5 mm and are spaced less than 8 mm apart, gastric peristalsis is insufficient to separate and / or move the magnets. Assuming that the 4 pair coil device contains magnets with a diameter of 2.5 mm, the amount of normal small bowel peristalsis is insufficient to separate and / or move the magnets.

[0422] Example 6: Device with 3.0 mm diameter magnet and different number of coil loops on each side of the anastomosis

[0423] Figure 39K and Fig.39JGraphs showing the relationship between the compression pressure and the distance between the coil loops and the relationship between the force and the distance between the coil loops provided by an anastomotic device having a magnet with a diameter of 3.0 mm and having a different number of coil loops on each side of the anastomosis to be formed, respectively, according to an embodiment of the present specification. Figure 39K and Fig.39J As shown, both pressure (P) and force (F) increase as the distance (d) between the coil loops decreases. Curves 3980 and 3990 represent a device with a magnet of 3.0 in width or diameter, an internal coil radius of 10 mm, and a pair of coil loops (1 coil on each side of the anastomosis to be formed). Curves 3981 and 3991 represent a device with a magnet of 3.0 in width or diameter, an internal coil radius of 10 mm, and two pairs of coil loops (2 coils on each side of the anastomosis to be formed). Curves 3982 and 3992 represent a device with a magnet of 3.0 in width or diameter, an internal coil radius of 10 mm, and three pairs of coil loops (3 coils on each side of the anastomosis to be formed). Curves 3983 and 3993 represent a device with a magnet of 3.0 in width or diameter, an internal coil radius of 10 mm, and four pairs of coil loops (4 coils on each side of the anastomosis to be formed). Increasing the number of coil loop pairs increases the pressure and force generated by the device at the same distance. For example, a device with four coil loop pairs represented by curves 3983, 3993 produces a pressure of about 11.6 psi (0.08 MPa) and a force of about 16 N at a distance of about 0.6 cm between the coil loops, while a device with only one coil loop pair represented by curves 3980, 3990 produces a pressure of about 2.9 psi (0.02 MPa) and a force of about 4 N at the same distance. Figure 39K , once by Figure 39K The pressures produced by the devices shown fall below the assumed maximum gastric pressure 3984, and spontaneous separation of gastric anastomoses formed by all of these devices can occur within the range of 0.84 to 1.0 cm distance between the coil loops, as depicted in box 3986. Since no curves are below the assumed maximum small bowel pressure 3985, no device is susceptible to small bowel anastomosis separation. Therefore, assuming that the 4-pair coil device contains magnets with a diameter of 3.0 mm and are spaced less than 8.4 mm apart, gastric peristalsis is insufficient to separate and / or move the magnets. Assuming that the 4-pair coil device contains magnets with a diameter of 3.0 mm, the amount of normal small bowel peristalsis is insufficient to separate and / or move the magnets.

[0424] Fig.40AAn exemplary device 4000 for forming anastomosis in a pre-coil configuration according to one embodiment of the present specification is shown. Device 4000 includes a shape memory alloy (SMA) wire 4002, and a plurality of magnets 4004 and spacers 4006 are alternately and coaxially positioned around the wire 4002. In one embodiment, the wire 4002 is composed of nitinol. In one embodiment, the spacer 4006 is composed of a non-ferromagnetic material. In various embodiments, the spacer 4006 includes a silicone or nitinol tube or an O-ring or a round ball. In one embodiment, as shown in the figure, the length of the device 4000 for forming anastomosis in the pre-coil configuration is in the range of 440 to 460 mm. In one embodiment, the proximal end 4000p of the device 4000 includes a device connector 4008 for attaching the device 4000 for forming anastomosis to a delivery device. In one embodiment, the device connector 4001 is a threaded nut, and the device 4000 is connected to the delivery device by a threaded mechanism.

[0425] Fig.40B and Fig.40C shows a coiled configuration Fig.40A Device 4000 for forming anastomosis. Fig.40A , Fig.40B and Fig.40C After placement, and when exposed to body temperature, the SMA wire 4002 coils to move the device 4000 from Fig.40A The uncoiled configuration shown moves to Fig.40B and Fig.40C The coiled configuration shown. The spacer 4006 ensures that the magnets 4004 do not gather together on the device 4000. In one embodiment, the device 4000 is provided with a connector 4008 at the proximal end of the wire 4002 for connection to a delivery device. In one embodiment, the length of the anastomotic device 4000 in the coiled state is in the range of about 22 to 23 mm.

[0426] Fig.40D An example of a method for converting Fig.40A , Fig.40B and Fig.40CThe delivery device 4010 for delivering the anastomotic device 4000 to a predetermined location in the body is shown. The delivery device 4010 includes a handle 4016 including a first proximal portion 4017 having a port 4012 and a second distal portion 4019; a body 4014 including an outer tubular sheath 4013 coaxially positioned around an inner shaft 4015; and a distal tip 4018, and is used to deliver the SMA anastomotic coil 4000 into the human body through an endoscope (not shown). The first proximal portion 4017 of the handle 4016 is movable relative to the second distal portion 4019, which moves the inner shaft 4015 into and out of the outer tubular sheath 4015 at the distal end of the delivery device body 4014. During delivery, a warm liquid can be introduced through the port 4012, and when contacting the shape memory alloy of the anastomotic device 4000, the liquid helps to change the anastomotic device 4000 from its linear pre-deployment configuration to its coiled post-deployment configuration. Fig.40E , Fig.40F and Figure 40G A connection to an embodiment of the present specification is shown. Fig.40B and Fig.40C The coiled anastomotic device 4000 shown Fig.40D The delivery device 4010 shown. In some embodiments, the distal tip 4018 of the inner shaft 4015 is provided with a delivery connector 4020 for connecting to the anastomotic device 4000 via the device connector 4008. In one embodiment, the delivery connector 4020 comprises a spiral mandrel, the device connector 4008 comprises a threaded nut, and the delivery connector 4020 and the device connector 4008 together comprise a spiral mechanism for connecting the delivery device 4010 to the device 4000 for forming an anastomosis. In one embodiment, before placement, the anastomotic device 4000 is as follows Fig.40A The depicted linear configuration is positioned within an outer tubular sheath 4013 of a delivery device body 4014, which helps to constrain the anastomotic device 4000 and prevent it from coiling prior to delivery to a predetermined location within a patient's body. The body 4014 is in the shape of a long tube and is inserted into the body through a channel of an endoscope so that a distal tip 4018 (in a non-coiled shape) connected to the anastomotic device 4000 protrudes from the distal end of the endoscope. Fig.40D , Fig.40E , Fig.40F and Figure 40G Once the delivery device 4010 is positioned at a predetermined location within the human body, the handle 4016 is actuated to extrude the anastomotic device 4000 from the outer sheath 4013 and to disengage the delivery connector 4020 from the device connector 4008, thereby placing the anastomotic device 4000 in a coiled configuration.

[0427] Figure 40H4021, an endoscope is inserted into a patient's body so that the distal end of the endoscope is located near a predetermined anastomosis formation position. In step 4022, an anastomosis device having a device connector at its proximal end is connected to a delivery device through a delivery connector located at the distal end of the delivery device in a linear pre-placement configuration and is retracted into a tubular sheath of the delivery device using a delivery device handle. In step 4023, the distal end of the delivery device with the anastomosis device attached is inserted into an instrument channel of the endoscope. Then, in step 4024, a user manipulates the handle of the delivery device to advance the delivery device beyond the distal end of the endoscope and extend the anastomosis device out of the tubular sheath to position the anastomosis device near a predetermined anastomosis formation position. Optionally, in step 4025, the user injects a warm liquid through a port on the delivery device handle, or provides an electric current to the device to heat the device, thereby helping the anastomosis device to transform from a linear pre-placement configuration to a coiled post-placement configuration. At step 4026, the user actuates the handle to disengage the delivery connector from the device connector, thereby allowing the anastomotic device to be separated from the delivery device, coiled into its post-deployment configuration, and form the anastomosis. At step 4027, the delivery device and endoscope are removed from the patient.

[0428] refer to Fig.41 In another embodiment, according to one embodiment of the present specification, the SMA wire 4100 is coupled to magnets 4108, 4108a, 4108b, 4108c, 4108d before being placed in the body to form an anastomosis. Prior to placement, the SMA wire 4100 is relatively straight and is divided into at least three sections 4102, 4104, and 4106. Sections 4102 and 4106 are coupled to a plurality of magnets 4108, 4108a, 4108b, 4108c, 4108d such that the positions of the first magnet 4108a, 4108c and the last magnet 4108b, 4108d of sections 4102 and 4104, respectively, are fixed and immovable. In one embodiment, elements 4108a, 4108b, 4108c, and 4108d are non-magnetic fixed elements. The remaining magnets 4108 of each section may be fixed or may move / slide within the space between the first and last magnets of each section. As shown, no magnets are provided on section 4104. A plurality of washers or rings or other space occupying elements 4152 made of a biocompatible material such as PTFE are provided on section 4104, wherein the rings 4152 include a lumen through which the central wire 4190 passes. In another embodiment, section 4104 may have magnets, as provided in sections 4102 and 4106, and the rings 4152 may be placed between the magnets.

[0429] refer to Fig.42In another embodiment, according to an embodiment of the present specification, the SMA wire 4200 is coupled to magnets 4208, 4208a, 4208b, 4208c, 4208d before being placed in the body to form an anastomosis. Prior to placement, the SMA wire 4200 is relatively straight and is divided into at least three sections 4202, 4204, and 4206. Sections 4202 and 4206 are coupled to a plurality of magnets 4208, 4208a, 4208b, 4208c, 4208d such that the positions of the first magnet 4208a, 4208c and the last magnet 4208b, 4208d of sections 4202 and 4204 are fixed and immovable, respectively. The remaining magnets 4208 of each section may be fixed or may move / slide within the space between the first and last magnets of each section. As shown, there are no magnets on section 4204. A mechanism 4253 is provided on part 4204 to provide immediate drainage between the two sections to be anastomosed. In one embodiment, the mechanism 4253 is a stent, which includes a wire mesh and a biocompatible material film covering the wire mesh. The mechanism or stent 4253 is compressible and expandable, wherein, when expanded, the stent 4253 is a cylinder having a length and a constant radius on a portion of the length. Optionally, the stent 4253 can be formed into a barbell-like shape, including a central cylindrical portion having a first radius and an end cylindrical portion having a second radius, wherein the second radius is greater than the first radius. Optionally, the stent 4253 is a cylinder having a length and a non-constant radius on the length. In each embodiment, the stent 4253 is located on a central wire 4290 passing through the length of the stent 4253, fixed to the central wire 4290 or one or more magnets by sutures 4254, and expanded from a compressed state before placement to an expanded state after placement. In other embodiments, other fixing mechanisms known in the art, such as crimping, gluing, or welding, are used to fix the mechanism 4253 to the center wire 4290.

[0430] Fig.43AAn image of a coiled device 4300 is shown having a distal end (ceramic tip) 4302 that is bent inward to prevent an edge or end from being too sharp, in accordance with one embodiment of the present specification. The proximal end (screw end) (not shown) may also be bent inward. In some embodiments, the end is bent inward 0 to 180 degrees relative to the circle defined by the coil of the device, forming a non-damaging u-shape. This prevents the end from protruding tangentially relative to the circle of the coil loop, eliminating rough or sharp edges. In some cases, the distal end 4302 may point in a direction away from the coil of the device 4300, which is undesirable because the sharp edges formed may accidentally damage tissue. Therefore, the distal end 4302 may also bend inward. Referring to the figure, a first arrow 4304 indicates the direction in which the distal end would extend without the inward bend. A second arrow 4303 indicates the position of the inward bend of the distal end. A third arrow 4306 pointing substantially horizontally indicates a new orientation of the distal end 4302, which in some embodiments is approximately 0-180 degrees inward relative to the coil shape, more preferably 15-20 degrees, to eliminate potential hazards caused by sharp ends. In some embodiments, electropolishing is used during the manufacture of the coil 4300 to reduce sharp edges produced by laser cutting. In addition, both the coil 4300 and the magnet have smooth / rounded edges. Sharp edges are avoided and / or eliminated by design. In an embodiment, the maximum magnet volume is accommodated within the available space in the delivery device. Pressure is generated by the strength of the magnet, which can cause tissue necrosis, leading to dehiscence. Sharp edges are also undesirable because they may force the anastomosis to accelerate relative to the "natural" pressure. An ideal anastomosis is formed between day 1 and week 2. In some embodiments, a bevel is added to produce a smaller, rounder edge. In some embodiments, polishing is used to eliminate rough or sharp edges.

[0431] Fig.43B A scaled side view of a coiled device 4310 with an inwardly curved distal end is shown, in accordance with one embodiment of the present description. Fig.43C The distal end of the inwardly curved Fig.43B Scaled rear view of the coiled device 4310. In an embodiment, the total length of the coiled device 4310 is less than 650 mm, and the diameter of the cylinder formed by the coiled device 4310 is up to 50 mm.

[0432] Fig.43DA coil device 4320 is shown in accordance with an alternative embodiment of the present specification. Coil device 4320 includes eight coil loops (four on each side of the anastomosis) formed during the placement process. Coil device 4320 is similar to the coil device described in the previous embodiment, but includes a relatively smaller magnet than the magnet in the coil device of the previous embodiment. In one embodiment, the magnet of coil device 4320 has a diameter of 2.5 mm. In an embodiment, the distal 1 cm of the coil of coil device 4320 is scored around the inner circumference of the coil to improve the bend on the EUS puller. Alternatively, in some embodiments, a 1 cm spring tip coil is welded to the distal portion of the coil. In an embodiment, the end of the coil is bent inward 15-20 degrees during shape setting to avoid sharp edges or pre-set bends to assist puncture.

[0433] In one embodiment, a 30 degree bend is created at the ceramic tip, including 10 degrees to the EUS lifter and 20 degrees to the bend. In an embodiment, the outer diameter of the magnet of the various coil devices ranges from 2 mm to 5 mm, and the volume is 2 mm 3 Up to 400mm 3 In an embodiment, the coil length determines the size of the anastomosis. In one example, a coil with a diameter of 2 cm produces a hole of approximately 2 cm diameter for the anastomosis. In an alternative embodiment, less than eight coil loops are configured.

[0434] Fig.44A , Fig.44B , Fig.44C , Fig.44D , Fig.44E and Fig.44F A double coil device 4400 with a PTFE wire having an optional wire 4406 that mechanically and / or electrically connects the two coils 4402 and 4404 according to one embodiment of the present specification is shown. In an embodiment, the wire 4406 provides electrical contact with a cautery tip 4403 at the distal end of the device 4400, which heats up when an electric current is delivered to provide thermal energy to pierce body tissue. The wire 4406 is also used to mechanically connect the two coils 4402, 4404 of the device 4400. In an embodiment, the coil 4402 includes a distal coil support ring. The figure shows two coil loops of the coil 4402. Similarly, the coil 4404 includes a proximal coil support ring. The figure shows two coil loops of the coil 4404. Fig.44A shows a horizontal side view of the coil arrangement 4400, Fig.44B A front view of the coil assembly 4400 is shown, with the distal coil 4402 facing forward and the proximal coil 4404 facing backward. Fig.44C shows a cross-sectional view of a coil arrangement 4400, Fig.44D A close up view of a cross section of the proximal coil 4406 is shown, Fig.44EA vertical side view of coil arrangement 4400 is shown, Fig.44F Shows Fig.44E 4404. An embodiment of the coil device 4400 includes a wire 4406 connecting the distal coil 4402 and the proximal coil 4404, which is configured to introduce a puncture point in the middle of the coil loops of the two coils 4402 and 4404. In some embodiments, the wire 4406 is a spring wire. Therefore, the wire 4406 eliminates the possibility of leakage at the puncture site.

[0435] In one embodiment of the present embodiment, two coil segments 4402 and 4404 are configured with magnets 4408 having opposite directivities, one of the two coils having a clockwise direction and the other having a counterclockwise direction. The opposite directions of the two coils can ensure that the proximal coil 4404 is correctly placed during placement without being limited by the torque that increases due to the distal coil 4402 being fixed in the distal organ and not being able to rotate freely. In addition, the opposite directivities of the coil segments offset the strain in the opposite coil segments, thereby minimizing the strain transmitted to the catheter in its pre-placement position, causing the delivery catheter containing the coil to twist. In an alternative embodiment, this can be achieved by a flexible connection to the delivery catheter that allows the coil to rotate freely during placement, thereby releasing any torsion in the coil and allowing the coil to be placed correctly. In another embodiment, the reverse rotation of the proximal half of the coil relative to the direction of the torque generated during placement allows the torsional energy to be released by the internal propeller of the handle of the delivery device. In another embodiment, loosening the release mechanism when the coil is placed can release the torque in the coil. In this embodiment, the pitch direction of the screw makes it possible to loosen the coil from the screw to relieve the torque.

[0436] Fig.45 A scissor-like cutting action of a coil device 4500 placed according to one embodiment of the present specification is shown. After the coil device 4500 including the distal coil segment 4504 and the proximal coil segment 4502 is placed, a scissor-like compression and cutting action is performed when at least two attractive forces F1 4506 and F2 4508 are applied between the magnets of the coils 4502 and 4504. Forces 4506 and 4508 are attractive forces at different points of the circumference of the loops of the coil segments 4502 and 4504 adjacent to each other. Force 4506 is greater than force 4508. In some embodiments, adjacent loops of the two coils 4502 and 4504 have different circumferences. In an embodiment, the different circumferences are achieved by changing the thickness of the magnet in one loop of the proximal coil 4504 compared to another adjacent coil from the distal coil 4502.

[0437] Fig.46Ais an illustration of a device for forming an anastomosis according to one embodiment of the present specification, the device including a bridging element. Device 4600 includes two loops 4602, 4604 of SMA wire, with a bridging segment 4606 connecting the two loops. In various embodiments, the loops 4602 and 4604 are coiled in opposite directions to reduce the torque experienced by the SMA wire when the straight wire changes shape to form the loops 4602, 4604 after placement. The reduction in torque causes the SMA wire to coil in a desired manner, as explained with reference to the embodiments of the anastomotic device described above. In an embodiment, the overlap between the ends of the two loop segments 4602, 4604 ranges from 5% to 100% of the circumference of the loop. In one embodiment, as Fig.46A As shown, the overlap between the ends of the two ring segments 4602, 4604 is 25 mm. In various embodiments, the bridge element 4606 is made of the same SMA material as the rings 4602, 4604. In one embodiment, the bridge element 4606 is made of a material different from the SMA material of the rings 4602, 4604.

[0438] Fig.46B is an illustration of another device for forming an anastomosis including a bridging element according to another embodiment of the present specification. The anastomotic device 4610 includes two loops 4612, 4614 of SMA wire having an "S" shaped bridging section 4616 connecting the two loops. In various embodiments, the loops 4612 and 4614 are coiled in opposite directions to reduce the torque on the SMA wire when the straight wire changes shape to form the loops 4612, 4614 after placement. Fig.46A Compared to the straight bridge segment 4606 shown, the bridge segment 4616 of the device 4600 is formed into a curved shape. The curved shape allows the SMA wire to be easily coiled in a desired manner when placed. In an embodiment, the overlap between the ends of the two ring segments 4612, 4614 ranges from 5% to 100% of the circumference of the ring. In one embodiment, as shown in FIG. Fig.46B As shown, the overlap between the ends of the two ring segments 4612, 4614 is 25 mm. In various embodiments, the bridge element 4616 is made of the same SMA material as the rings 4612, 4614. In one embodiment, the bridge element 4616 is made of a material different from the SMA material of the rings 4612, 4614.

[0439] Fig.46C , Fig.46D , Fig.46E , Fig.46F and Figure 46G An embodiment according to the present specification is shown. Fig.46BDifferent views of a coiled stapling device with a tip cover are shown. The stapling device 4620 includes two loops of SMA wire, a first loop 4622 and a second loop 4624, with an "S" shaped bridge segment 4626 connecting the two loops. In various embodiments, the first loop 4622 and the second loop 4624 are coiled in opposite directions to reduce the torque on the SMA wire / coil when the straight wire is coiled after placement. In addition, the opposite directions of the two coils cancel out the torsional potential energy in the coil in a straight position. The distal end of the first loop 4622 is bent inward to prevent sharp edges or ends and is covered with a ceramic tip 4628. The proximal end of the second loop 4624 is also bent inward and terminates in a screw 4630 for connection to a bolt on a delivery device during / after placement. In some embodiments, the ends are bent inward by 10 to 90 degrees. In some embodiments, the distal tip can be bent up to 180°, creating an atraumatic U-shaped curve at the tip. In some cases, the ends of the first and second loops may point away from the coil of the device 4620, which is undesirable because sharp edges may be created that could accidentally damage tissue. Therefore, the ends are bent inward. Fig.46C , arrows 4632, 4634 indicate the direction of the inward bend of the ends of the first ring 4622 and the second ring 4624, respectively, to eliminate potential mechanical damage caused by the sharp ends. In one embodiment, a plurality of rings made of a biocompatible material such as PTFE can be placed on the bridge segment 4626, wherein the rings include an inner cavity through which the bridge segment passes. In another embodiment, a plurality of magnets can be placed on the bridge segment 4626. In yet another embodiment, the bridge segment 4626 can have magnets and a PTFE film can be placed on the magnets. In another embodiment, a thin plastic, polymer or PTFE film can be placed on the entire device, from the distal ceramic tip to the proximal screw connection. In an embodiment, a thin plastic layer of a biocompatible material (such as PTFE) is placed at 0%-100% of the device. In an embodiment, the layer is located on certain components of the device, such as magnets or spacers. In various embodiments, the diameter of each curve of the bridge segment is between 25% and 75% of the diameter of the coil ring.

[0440] FIG. 47A to FIG. 47MDifferent views of a coiled compression / anastomotic device including a bridging segment according to one embodiment of the present specification are shown. The device 4700 includes a first set of loops 4702 and a second set of loops 4704 of SMA wire, wherein the first set of loops and the second set of loops are connected to a bridging segment 4706. In various embodiments, the first set of loops 4702 and the second set of loops 4704 are coiled in opposite directions to reduce the torque to which the SMA wire is subjected when the wire changes shape to form a plurality of loops 4702, 4704 after placement. The reduction in torque causes the SMA wire to coil in a desired manner, as explained with reference to the above-described embodiments of the anastomotic device. In addition, the bridging segment balances the torque in the two separate segments of the loop in a straight position, reducing the deformation of the flexible catheter in the segment in which the device is stored before placement. The bridging segment 4706 is formed into an "S"-shaped curve as shown in the figure, and is connected to the ends of the first and second loops by a short PTFE tube in one embodiment. In another embodiment, a thin plastic, polymer or PTFE film can be placed over the entire device, from the distal ceramic tip to the proximal screw connection. In various embodiments, the diameter of each curve of the bridge segment is between 25% and 75% of the diameter of the coil loop.The curved shape enables the SMA wire to be easily coiled in a desired manner when placed.

[0441] The device 4700 includes Fig.47C A shape memory alloy (SMA) wire 4701, a plurality of magnets 4708 and a spacer 4710 are shown alternately and coaxially positioned around the wire 4701. In one embodiment, the wire 4701 is composed of Nitinol. In one embodiment, the spacer 4710 is composed of a non-ferromagnetic material. In various embodiments, the spacer 4710 comprises a silicone or Nitinol tube or an O-ring or a round ball.

[0442] refer to FIG. 47A to FIG. 47MAfter placement, and when exposed to body temperature, the SMA wire 4701 is coiled to form a plurality of loops that can be divided into a first group of loops 4702 and a second group of loops 4704 connected by a bridging element 4706, wherein the first group of loops 4702 and the second group of loops 4704 are coiled in opposite directions. The spacer 4710 ensures that the magnets 4708 do not gather together on the device 4700 when in a straight pre-placement shape. The distal ends of the first group of loops 4702 are bent inward to prevent sharp edges or ends and are covered with a ceramic tip 4712, and the proximal end is connected to the first end of the "S" shaped bridge segment 4706. The proximal end of the second group of loops 4704 is also bent inward and terminated with a screw 4714 for connection with the inner member of the delivery catheter, and the distal end of the second group of loops 4704 is connected to the second end of the "S" shaped bridge segment 4706. In some embodiments, the ends are bent inward by 10 to 90 degrees. In one embodiment, the distal end is bent 180° to form a non-damaging U-shaped curve. In some cases, the ends of the first and second loops may point away from the coil of the device 4700, which is undesirable because sharp edges may accidentally damage tissue. Therefore, the ends are bent inward to prevent damage to tissue during and after placement. The bend in the ends also creates a rounded elbow 4716 in the coil 4701 (e.g., Fig.47A ), which prevents the tips of the first set of loops 4702 and the second set of loops 4704 that are not connected to the bridging element 4706 from scratching or catching tissue when the SMA wire is coiled and looped in the lumen of an organ after placement.

[0443] FIG. 47D to FIG. 47H Shows FIG. 47A to FIG. 47C The device is shown without magnets and spacers placed around the SMA wire. FIG. 47I to FIG. 47M Shows FIG. 47A to FIG. 47C Various views of device 4700 are shown in which magnet 4708 is plated with a corrosion resistant material, such as gold or titanium, or coated with plastic or PTFE, and in which spacer 4710 is an O-ring made of PTFE or another biocompatible, non-ferromagnetic material. Figures 47N to 47S Shows FIG. 47A to FIG. 47C In the device shown, PTFE washers 4730 are disposed around the "S" shaped bridging element 4706. The PTFE washers have a diameter similar to that of the magnets and act as fillers to prevent the flexible catheter containing the device from collapsing in the S segment portion, thereby accidentally jamming the device and interfering with its placement. In one embodiment, the bridging element 4706 passes through approximately 20 to 25 PTFE washers 4730. In one embodiment, the diameter of the SMA wire 4701 passing through the magnet 4708 is approximately 0.75 mm, while the diameter of the magnet 4708 is approximately 2.9 mm, as shown in FIG. Figure 47R shown. Figure 47Q They are shown respectively Figure 47NDifferent parts of the anastomotic device are shown. In various embodiments, a nitinol tube having a central lumen to accommodate a guide wire can be used instead of a solid nitinol wire.

[0444] Figure 47T Another view of a coiled stapling device including a bridging segment is shown according to one embodiment of the present specification. The device 4780 includes a first set of loops 4782 of SMA wire forming a proximal coil and a second set of loops 4784 of SMA wire forming a distal coil, wherein the first and second sets of loops are connected to a bridging segment or connecting member 4786. A plurality of magnets 4788 and spacers 4790 are alternately and coaxially positioned around the SMA wire. In one embodiment, the bridging segment 4786 is an "S" shaped connecting member that can include a drainage structure configured to provide an immediate connection between two cavities connected by the anastomosis. Figure 47T The connecting member 4786 shown does not include a drainage structure of an "S" shaped connector. In various embodiments, the connecting member 4786 is used to provide a connection between the proximal coil and the distal coil. In addition, the "S" shaped connecting member 4786 provides a pulling force that pulls the two coil loops of the device 4780 together to help pull the two body tissues to be anastomosed with an inner cavity together. When the two device loops are farthest apart, the pulling force of the S curve is the largest. As the loops are pulled together, the pulling force of the S curve decreases, and the attraction of the magnet works to complete the anastomosis. In an embodiment, the length of the connecting member 4786 is greater than the diameter of the SMA coils forming the loops 4782 and 4784, but is less than or equal to the circumference of the coils, so that the coils 4782 and 4784 can be gathered together and the magnets 4788 can be aligned. The "S" shape of the connecting member 4786 enables the perforation produced by the tip 4792 of the SMA coil to be located within the periphery of the two coils 4782 and 4784.

[0445] Fig.48A and Fig.48B An anastomotic device according to one embodiment of the present specification is shown, the anastomotic device including a bridging section on which a drainage mechanism is disposed. The device 4800 is a coil and includes a first set of loops 4802 and a second set of loops 4804 of SMA wire, wherein the first set of loops and the second set of loops are connected to an "S"-shaped bridging section 4806. In various embodiments, the first set of loops 4802 and the second set of loops 4804 are coiled in opposite directions to reduce the torque on the SMA wire during placement. In an embodiment, as Fig.48A , Fig.48BAs shown, an expandable wire mesh drainage mechanism 4808 having a biocompatible material covering the wire mesh is positioned around the bridge segment 4806. In some embodiments, the expandable wire mesh drainage mechanism 4808 is a stent. The wire mesh drainage mechanism 4808 is compressible and expandable, wherein, when expanded, the wire mesh drainage mechanism is a cylinder having a length and a constant radius over the length and containing a lumen therethrough, such as Fig.48A shown. Fig.48A The wire mesh drainage mechanism in is depicted in a compressed pre-placement configuration. Optionally, the wire mesh drainage mechanism 4808 can be formed into a barbell-like shape, including a central cylindrical portion having a first radius and an end cylindrical portion having a second radius, wherein the second radius is greater than the first radius, and an inner cavity passing therethrough, such as Fig.48B As shown. Optionally, the wire mesh drainage mechanism 4808 is a cylinder having a length and a non-constant radius over the length. In each embodiment, the wire mesh drainage mechanism 4808 is positioned on and fixed to the bridge segment 4806 so that the bridge segment 4806 extends through the lumen of the wire mesh drainage mechanism 4808 and expands from a compressed state before placement to an expanded state after placement. Fig.48A , Fig.48B The use of the wire mesh drainage mechanism 4808 shown eliminates the need for a PTFE tube to cover the bridging element 4806.

[0446] The bridging segments extending across the stent lumen are preferably independent and separate from the expandable outer shell defining the expandable wire mesh drainage mechanism or the stent exterior. Figure 50G As shown, an expandable shell defining a cylinder through which fluid can be drained can be tethered to the proximal or distal end of the bridging segment. However, the wire mesh defining the expandable shell is not bonded or interwoven with the bridging segment itself. By not making the bridging segment part of the wire mesh or stent shell, unnecessary interference with the expansion and contraction of the wire mesh or stent can be avoided while still ensuring that the wire mesh drainage mechanism or stent remains in place to promote drainage.

[0447] Fig.48C It shows that some embodiments of the present invention can be used for Fig.48A and Fig.48BThe invention provides a plurality of expandable wire mesh drainage mechanisms for anastomotic devices. The wire mesh drainage mechanism 4820 is a metal stent with opposite lumens, which has a cylindrical portion 4822 defined by flanges 4824, 4826. The inner diameter of the wire mesh drainage mechanism 4820 ranges from 10 mm to 25 mm, and the length of the cylinder 4822 between the flanges 4824, 4826 is approximately 5-15 mm. The wire mesh drainage mechanism 4830 is a metal stent with opposite lumens, which has a cylindrical portion 4832 with an inner diameter ranging from 8 mm to 26 mm and flanges 4834, 4836. The length of the cylinder 4832 between the flanges 4834, 4836 is approximately 5-15 mm. The wire mesh drainage mechanisms 4840, 4850 and 4860 are double-flange metal stents, each including a cylindrical portion having a first diameter, which is defined by a flange having a diameter greater than the first diameter. The diameter of the cylindrical portion 4842 of the bracket 4840 ranges from 10 mm to 26 mm, and the length between the flanges 4844, 4846 ranges from 10 mm to 30 mm. The diameter of the cylindrical portion 4852 of the wire mesh drainage mechanism 4850 ranges from 8 mm to 25 mm, and the length between the flanges 4854, 4856 is approximately 30 mm. The diameter of the cylindrical portion 4862 of the wire mesh drainage mechanism 4860 is approximately 14 mm, and the length between the flanges 4864, 4866 ranges from 10 mm to 30 mm.

[0448] FIG. 49A to FIG. 49DDifferent views of an anastomotic device according to one embodiment of the present specification are shown, the anastomotic device including a wire mesh drainage mechanism located above an "S" shaped bridging element. The device 4900 includes a first set of loops 4902 and a second set of loops 4904 of an SMA wire 4901, wherein the first set of loops and the second set of loops are connected to an "S" shaped bridging segment 4906. In various embodiments, the first set of loops 4902 and the second set of loops 4904 are coiled in opposite directions to reduce the torque borne by the SMA wire 4901 when the wire changes shape to form multiple loops after placement. A plurality of magnets 4908 and spacers 4910 are alternately and coaxially positioned around the wire 4901. In one embodiment, the SMA wire 4901 is composed of Nitinol. In one embodiment, the spacer 4910 is composed of a non-ferromagnetic material. In various embodiments, the spacer 4910 comprises a silicone, PTFE or Nitinol tube or an O-ring or a round ball. The distal end of the first ring 4902 is bent inward to prevent sharp edges or ends and is covered with a ceramic tip 4912. The ceramic tip can accommodate a cautery wire used for electrocautery to pierce the organ wall. The proximal end of the second ring 4904 is also bent inward and terminates in a screw 4914 for connection to a delivery device during / after placement. A drainage mechanism such as a stent 4916 made of a wire mesh and a biocompatible material covering the wire mesh is placed around the bridging segment 4906. The stent 4916 is compressible and expandable, positioned and fixed on the bridging element 4806. The stent 4916 expands from a compressed state before placement to an expanded state after placement.

[0449] FIG. 50A to FIG. 50D Different views of an anastomotic device in a pre-placement state according to one embodiment of the present specification are shown, the anastomotic device including a wire mesh drainage mechanism positioned on a bridging element. The device 5000 includes an SMA wire 5001 having a plurality of magnets 5004 and spacers 5006 positioned alternately and coaxially around the wire 5001. A first portion 5008 of the wire 5001 is coupled to a second portion 5010 of the wire 5001 by a bridging segment 5012, which is at least partially covered by the wire mesh drainage mechanism 5014, as shown. The distal tip of the portion 5010 is covered by an optional ceramic tip 5016. The proximal tip of the portion 5008 terminates in an optional screw 5018. In one embodiment, the overall length of the device 5000 is approximately 283 mm, ranging between 172 mm and 382 mm; the length of the bridging section 5012 is approximately 44 mm, ranging between 31.3 mm and 127.3 mm; and the length of the stent 5014 is approximately 15 mm, ranging between 10 mm and 25 mm.

[0450] Fig.50E The following figure shows the placement of an embodiment according to the present specification. FIG. 50A to FIG. 50DAfter placement, when exposed to body temperature, the SMA wire 5001 coils to form a plurality of loops, wherein the first portion 5008 forms a first set of loops 5009 and the second portion 5010 forms a second set of loops 5011. The bridge section 5012 is curled into an "S" shape, and the wire mesh drainage mechanism 5014 is located around it. Fig.50F An embodiment according to the present specification is shown. Fig.50E A device in which no wire mesh drainage mechanism is positioned on the bridging segment and placed in a predetermined position.

[0451] Figure 50G and Figure 50H An embodiment according to the present specification is shown. FIG. 50A to FIG. 50D The device shown and the method for attaching the wire mesh drainage mechanism to the bridging segment. In one embodiment, a flexible attachment such as a suture 5013 is used to secure the wire mesh drainage mechanism 5014 to the bridging segment 5012 by using a press 5017. In an embodiment, the press is composed of a metal material. In various embodiments, the wire mesh drainage mechanism 5014 is attached to the bridging segment 5012 in a manner that allows the wire mesh drainage mechanism 5014 to expand and move laterally while still being fixed in a predetermined position on the bridging segment 5012. In one embodiment, the compressed length of the wire mesh drainage mechanism 5014 is less than πr, where r is the radius of the coil 5001. In one embodiment, the expanded diameter of the wire mesh drainage mechanism 5014 is between 3 mm and 30 mm.

[0452] Fig.50I A view of an anastomotic device in a post-placement state according to one embodiment of the present specification is shown, the anastomotic device including a wire mesh drainage mechanism positioned on a bridging element. After placement, when exposed to body temperature, an anastomotic device 5080 including an SMA wire having a plurality of magnets 5086 and spacers 5088 positioned alternately and coaxially around the SMA wire is coiled to form a plurality of loops, wherein a first portion of the coil forms a first set of loops 5082 and a second portion of the coil forms a second set of loops 5084. A bridging segment 5090 connecting the first and second sets of loops is curled into an "S" shape. As shown, a wire mesh drainage mechanism 5092 is located above the connecting member 5090. The wire mesh drainage mechanism 5092 leaves a hole with a diameter of at least 3 mm in the wall of the patient's organ. The hole allows fluid to flow through the organ wall, thereby reducing pressure accumulation in the organ for a limited time until the anastomotic device forms a larger permanent anastomosis, and then the entire device is passed through the organ, such as the colon.

[0453] In one embodiment, an anastomotic device 5080 having a wire mesh drainage mechanism 5092 is placed in the transected colon, wherein a purse-string suturing technique using sutures or staples is used to close the ostium of the transected colon (at Fig.55), a wire mesh drainage mechanism 5092 extends between the colon proximal to the transected portion and the colon distal to the transected portion, allowing instant fluid connection and drainage from the colon proximal to the transected portion to the colon distal to the transected portion.

[0454] Fig.50J The configuration before placement according to one embodiment of the present specification is shown. Fig.50I 5080 includes an SMA wire having a plurality of magnets 5086 and spacers 5088 positioned alternately and coaxially around the wire. A first portion 5082 of the wire is coupled to a second portion 5084 of the wire by a bridging segment 5090, which is at least partially covered by a wire mesh drainage mechanism 5092, such as Fig.50I , Fig.50J For illustration purposes, Fig.50J In the embodiment, the first and second parts 5082, 5084 of the metal wire are connected from Fig.50I The coiled state after placement shown in is straightened. The wire mesh drainage mechanism 5092 is made of a wire mesh and a biocompatible material covering the wire mesh. The wire mesh drainage mechanism 5092 is compressible and expandable and is positioned and fixed to the bridging element 5090 using sutures 5094. The wire mesh drainage mechanism 5092 expands from a compressed state before placement to an expanded state after placement. In one embodiment, the device 5080 is covered with a material such as, but not limited to, PTFE to make it easier to insert into the patient's body without hooking the tissue (at the edge). In one embodiment, in order to be easily inserted into the patient's body, only the magnet is round or covered with a material such as, but not limited to, PTFE, fluorinated ethylene propylene (FEP) or perfluoroalkoxy (PFA). Materials that can be shrink-wrapped at temperatures below 80°C, more preferably below 60°C, can be used to cover the magnet.

[0455] Figure 50K Shows FIG. 50A to FIG. 50DThe anastomotic device including a wire mesh drainage mechanism 5014 disposed on a bridging element 5012 in a pre-placement state is shown. The wire mesh drainage mechanism 5014 is shown in an expanded state and is shaped like a barbell, comprising a central cylindrical portion having a first radius, a first end cylindrical portion 5015a and a second end cylindrical portion 5015b, wherein the first end cylindrical portion 5015a and the second end cylindrical portion 5015b have a second radius, wherein the second radius is greater than the first radius. The device 5000 is placed in the lumen of an organ, close to and surrounding a puncture in the wall of two adjacent organs, the puncture being created by a delivery catheter. When the device 5000 is loaded into the catheter for delivery, the wire mesh drainage mechanism is compressed. After the device is placed, the wire mesh drainage mechanism 5014 blocks the puncture in the organ wall and provides fluid communication between the lumens of the two adjacent organs. After placement, the first portion 5008 and the first end cylindrical portion 5015a of the device 5000 remain on one side of the puncture in the organ wall, while the second portion 5010 and the second end cylindrical portion 5015b are placed on the other side of the puncture in the organ wall, with two loops of the coil surrounding each puncture in the organ wall. Figure 50L and Figure 50M Shows the status after placement Figure 50K Device. The plastic sheet 5020 including the opening 5022 represents the adjacent organ wall with the puncture hole passing therethrough. As shown, the wire mesh drainage mechanism 5012 is positioned in the opening 5022 so that the first part 5008 and the first end cylindrical part 5015a remain on the left side of the opening 5022, while the second part 5010, the second end cylindrical part 5015b and the majority of the bridging section 5012 pass through and are placed on the right side of the opening 5022 in the plastic sheet 5020, thereby positioning the wire mesh drainage mechanism in the opening 5022, while providing fluid communication from the right side to the left side by the wire mesh drainage mechanism. The magnets 5004 on the first and second parts 5008, 5010 attract each other, thereby keeping the device 5000 in place. The spacer 5006 ensures that the magnets 5004 will not gather together on the device 5000, particularly in the device's front straight configuration.

[0456] Figure 50N and Fig.50O A perspective view and a side view of an anastomotic device 5091 including a wire mesh drainage element 5099 according to some embodiments of the present specification are shown. According to one embodiment of the present specification, the anastomotic device 5091 is similar to Figure 47TThe device shown in FIG. 5091 includes a first group of loops 5093 of SMA wire forming a distal coil and a second group of loops 5095 of SMA wire forming a proximal coil, wherein the first and second groups of loops are connected by a bridging segment or connecting member 5087. A plurality of magnets 5097 and spacers 5098 are alternately and coaxially positioned around the SMA wire. In one embodiment, the bridging segment 5087 is an "S" shaped connecting member covered by a wire mesh drainage element 5099, which is configured to provide an instant connection between two cavities engaged in the anastomosis. In various embodiments, the connecting member 5087 is used to provide an electrical connection and a mechanical connection between the proximal coil and the distal coil. The electrical connection provides an electric current to the cautery tip 5096 to pierce the body tissue. In addition, the "S" shaped connecting member 5087 provides a pulling force that pulls the two loops of the device 5091 together to help pull the two body tissues to be anastomosed with lumens together. When the two device rings are farthest apart, the tension of the S curve is greatest. As the rings are pulled together, the tension of the S curve decreases, and the attraction of the magnets takes effect, completing the anastomosis. In an embodiment, the length of the connecting member 5087 is greater than the diameter of the SMA coils forming the rings 5093, 5095, but less than the circumference of the coils, so that the coils 5093, 5095 can be brought together and the magnets 5097 can be aligned. The "S" shape of the connecting member 5087 enables the perforation created by the tip 5096 of the SMA coil to be located within the periphery of the two coils 5093, 5095. In an embodiment, the proximal end of the device 5091 includes a screw tip 5089 for connection to a delivery device.

[0457] Fig.51A A method for using an anastomotic device (such as Fig.47A The device 5100 is a device shown in the figure, which is connected to a push catheter for delivering the anastomotic device to a predetermined position in the body. The delivery device 5100 includes a catheter 5116, which includes an outer catheter portion 5117 attached to a proximal handle 5119 having a port 5112. The device also includes an inner push catheter 5113, which includes a first portion 5113a, a second portion 5113b and a stop mechanism 5115, which is connected to a distal handle 5118. The delivery device is used to deliver an SMA anastomotic device such as a laparotomy by any means (including but not limited to endoscopy, laparoscopy and laparotomy). Fig.50D The device 5000 is delivered into the human body. Through the distal handle 5118, the inner push catheter 5113 can be coaxially moved in the outer catheter part 5117.

[0458] The tip of the catheter is used to pierce the wall of the adjacent organ, and the tip of the catheter is placed in the first lumen of the first organ. The first part 5113a of the internal advancement catheter 5113 is pushed to place the first section of the coil and a portion of the S-shaped connector into the first lumen. The stop mechanism 5115 marks the end of the first step of placement and prevents the user from placing too many devices. Various imaging techniques can be used to verify the location and extent of placement. After accurate placement and sufficient placement are verified, the catheter is withdrawn and the catheter tip is positioned in the second lumen of the second organ, while the placement portion of the catheter is still in the first lumen. The second part 5113b of the internal advancement catheter 5113 is pushed after being disengaged from the stop mechanism 5115, and the remaining part of the anastomotic device is placed in the second lumen. Then, the anastomotic device is disengaged from the internal advancement catheter 5113, and the entire catheter is removed. In some embodiments, the second part 5113b of the internal advancement catheter 5113 can be telescoped in the first part 5113a to shorten the length of the advancement catheter 5113. In another embodiment, the internal push catheter 5113 includes three different sections separated by two separate stop mechanisms. In this embodiment, the three sections control the placement of the distal coil loop, the "S" shaped connecting section, and the proximal coil loop of the anastomotic device, respectively. The three sections can be telescopic to reduce the length of the push catheter. During delivery, a warm liquid can be introduced through the port 5112, and when it contacts the shape memory alloy of the anastomotic device, the liquid helps to change the anastomotic device from its linear pre-placement configuration to its coiled post-placement configuration. In one embodiment, as Fig.51B As shown, the proximal portion of the proximal handle 5116 includes an inner shaft 5155, which is coaxially surrounded by an outer shaft / barrel 5120. In one embodiment, the inner shaft 5155 includes grooves / pitch on the surface for controlling the movement of the inner shaft 5155 within the outer shaft / barrel 5120 of the proximal handle 5116. The inner shaft 5155 is configured to be pushed into the outer sheath / barrel 5120 and rotated relative thereto to place the anastomotic device, so that the inner shaft 5155 moves within the barrel 5120 until only the pitch 5123 is visible outside the barrel, at which time the inner shaft 5155 is rotated (loosened) in a counterclockwise direction to disengage the anastomotic device from the delivery device. Fig.51A and Fig.51B In the illustrated embodiment, the pitch 5124 disposed on the outer shaft 5120 engages with the pitch 5122 disposed on the inner shaft 5155, and the pitch 5122 disposed on the inner shaft 5155 relieves any tension on the stapling device held within the delivery device 5100. In one embodiment, optional pitches 5126, 5123 are disposed at the distal handle 5118 of the delivery device body 5114 and the proximal end of the inner shaft 5155, respectively, for disengaging the delivery device from the stapling device. Fig.51BIn an embodiment, the length of the groove 5121 is equal to the length of the distal coil loop segment and the "S" shaped connector of the anastomotic device, the length of the follow-up pitch groove 5129 is equal to the length of the proximal coil loop segment of the anastomotic device, and the rotational motion helps to release the torque of the proximal coil loop segment after placement. In an embodiment, the groove segment 5123 corresponds to the threaded connection that disconnects the anastomotic device from the delivery device.

[0459] Fig.51C An anastomotic device 5170 is shown comprising a wire mesh drainage element 5171 attached to a delivery device 5175 in accordance with some embodiments of the present specification. The anastomotic device 5170 is shown in a post-deployment configuration at the distal end of the delivery device 5175, about to be detached from the delivery device 5175.

[0460] In various embodiments, the stapling device or magnetic compression device of the present specification can be used to treat various sphincter dysfunctions by partial myotomy. Fig.52A and Fig.52B An anastomotic device for treating achalasia dysfunction in a patient's lower esophageal sphincter (LES) according to one embodiment of the present specification is shown. Achalasia is a medical condition in which the muscles in the lower esophagus fail to relax, preventing food from entering the stomach. Fig.52A As shown, a magnetic compression device 5200 including a first coil loop 5202 and a second coil loop 5204 is inserted through an endoscope into a patient diagnosed with achalasia. The second coil loop 5204 is placed at the distal end of the LES 5208, while the first coil 5202 is placed at the proximal end of the LES 5208. The coils 5202, 5204 apply pressure to the LES 5208, causing a portion of the sphincter to be compressed and removed, thereby creating a compression myotomy or opening 5209 in the LES 5208 to allow food to more easily pass from the esophagus 5210 into the stomach 5206, as shown in FIG. Fig.52B Device 5200 falls away and can be removed or passed naturally.

[0461] Fig.53A and Fig.53B A magnetic compression device for treating gastroparesis dysfunction by performing a myotomy in a patient's pyloric sphincter is shown according to one embodiment of the present specification. The pyloric sphincter acts as a valve that controls the flow of partially digested food from the patient's stomach to the small intestine. Fig.53A , Fig.53B As shown, a magnetic compression device 5300 including a first coil loop 5302 and a second coil loop 5304 is inserted through an endoscope into the pyloric sphincter 5308 of a patient diagnosed with gastroparesis due to the pyloric sphincter 5308 not being able to fully open. The second coil loop 5304 is placed at the distal end of the pyloric sphincter 5308 so that the second coil loop 5304 is located in the duodenum 5306, as shown in FIG. Fig.53A As shown, the first coil 5302 is placed at the proximal end of the pyloric sphincter 5308, so that the first coil ring 5302 is located in the stomach. Coils 5302, 5304 apply pressure to the pyloric sphincter 5308, causing a portion of the sphincter 5308 to be compressed and removed, thereby producing Fig.53B A myotomy port or opening 5309 is shown to allow contents to flow from the stomach 5307 to the duodenum 5306. The device 5300 is dislodged and can be removed endoscopically or naturally.

[0462] Fig.54A and Fig.54B A magnetic compression device for treating gastrointestinal strictures in the esophagus of a patient according to one embodiment of the present specification is shown. Gastrointestinal strictures in the esophagus may be formed due to narrowing of the esophageal passage, restricting the passage of food from the esophagus to the patient's stomach. Fig.54A , Fig.54B As shown, a magnetic compression device 5400 including a first coil loop 5402 and a second coil loop 5404 is inserted through an endoscope into an esophagus 5410 of a patient diagnosed with esophageal stenosis 5408. A portion 5412 of the esophagus 5410 near the stenosis 5408 is dilated. Fig.54A As shown, a first coil ring 5402 is placed near the stricture 5408, while a second coil ring 5404 is placed away from the stricture 5408. Coils 5402, 5404 apply pressure to the stricture 5408, resulting in circumferential compression and excision of a portion of the stricture 5408, creating an opening 5409 and eliminating the stricture 5408, thereby allowing the contents to pass normally through the esophagus 5410, and after a period of time, the expanded portion 5412 of the esophagus can be disintegrated. The device 5400 falls off and can be removed or passed naturally.

[0463] In various embodiments, the present specification provides a novel, flexible catheter-based magnetic compression anastomosis device and delivery system that can safely form gastrojejunal and jejunojejunal anastomosis. The anastomosis device can be used to perform surgeries such as, but not limited to, end-to-end colon anastomosis, as well as perform cholecystojejunostomy and cyst-gastrectomy for pseudocyst drainage. The device provides potential advantages over traditional anastomosis techniques by reducing or eliminating the risk of anastomotic leaks.

[0464] Fig.55is a flow chart illustrating a method for performing colorectal surgery to place an anastomotic device according to one embodiment of the present specification. In step 5502, the patient's peritoneal inflection point is located and a point approximately 15 cm above the inflection point is marked on the patient's colon. In step 5504, the patient's colon is transected at the marked point. In step 5506, the distal end of the transected colon is partially closed using sutures or staples. In one embodiment, a purse-string suture technique using a V-lock suture is used to close the stoma of the transected colon. In step 5508, the proximal portion of the colon is clamped to allow for insufflation. The resection of the colon creates a proximal colon segment that is not fluidly connected to the distal colon segment. In step 5510, an endoscope is inserted into the patient's distal colon segment through the anus. In step 5512, an anastomotic delivery device carrying a magnetic anastomotic device is inserted along or through the endoscope into the patient's distal colon segment. In an embodiment, the delivery device is such as Fig.51A As shown. At step 5514, the delivery device is inserted into the proximal colon segment by withdrawing the distal colon segment near the staple line / purse string of the suture. At step 5516, air is injected into the proximal colon segment through the delivery device to insufflate / dilate the proximal colon segment. In another embodiment, the air is injected through a laparoscopic needle. At step 5518, the first coil of the anastomotic device is freely and unobstructedly placed in the dilated proximal colon lumen. In an embodiment, care is taken to avoid having the coil tip "stuck" on the colon wall. At step 5520, the delivery device is pulled back until the "S" shaped segment of the anastomotic device connecting the first coil loop to the second coil loop is at least partially visible outside the proximal colon segment. In one embodiment, the delivery device is pulled back until 3 / 4 of the "S" shaped coil segment can be seen in the distal colon lumen. At step 5522, the second coil of the anastomotic device is placed at the distal end of the colon. At step 5524, the delivery device is separated from the anastomotic device and the delivery device is pulled out of the patient's body together with the endoscope. It should be noted during the placement process that all or part of the suture / staple line is retained within the coil loop, so that all or part of the suture / staple line is removed by the magnetic compression stapling device to leave minimal foreign matter in or around the anastomosis.

[0465] Fig.565604, an enterotomy is performed at a distance greater than about 10 cm from the target placement location, the enterotomy comprising surgically opening the patient's small intestine. In one embodiment, the enterotomy is performed by using a cautery device and a cautery delivery system. In another embodiment, the enterotomy is performed by using a surgical tool. In an embodiment, the enterotomy is performed halfway between the mesenteric side and the anti-mesenteric side of the patient's colon. In step 5606, an endoscope is inserted into the patient's stomach through the patient's mouth. In an embodiment, the operator is provided with a tool for performing fluoroscopy in order to obtain a view of the patient's internal organs. At step 5608, air is brought into the patient's stomach through the endoscope to distend the stomach, thereby creating an air-filled volume to allow the coil to be placed freely without getting stuck in the stomach wall. In an embodiment, air may be introduced into the patient's distended stomach by other means, such as, but not limited to, an NG (nasogastric) tube or a laparoscopic needle. At step 5610, a catheter coupled to a magnetic compression stapling device is inserted through an enterotomy and exits through the anti-mesenteric side of the patient's jejunum. At step 5612, a catheter coupled to an anastomotic delivery device carrying the stapling device is inserted into the patient's stomach through an opening formed by the cauterizing tip of the stapling device or by another surgical tool. In an embodiment, a delivery device such as Fig.51A At step 5614, the tip of the delivery device is confirmed to be within the patient's stomach by using an endoscopic view.

[0466] At step 5616, the first coil loop of the anastomotic device is freely and unobstructedly placed in the dilated stomach. In embodiments, care is taken to avoid the coil tip from "getting stuck" on the stomach wall. At step 5618, the delivery device is pulled back until the "S" shaped segment of the anastomotic device connecting the first coil loop and the second coil loop is at least partially visible outside the stomach. In one embodiment, the delivery device is pulled back until 1 / 4 to 3 / 4 of the S-shaped coil segment can be seen. At step 5620, the patient's small intestine is pulled up over the delivery device near the patient's stomach so that the opening in the jejunum is aligned with the opening in the stomach wall so that the catheter tip and the proximal end of the second coil loop are positioned in the patient's small intestine. In embodiments, the technician needs to keep the delivery system stable / stationary while the operating surgeon uses grasping forceps to "pull" the small intestine on the delivery system to the stomach. At step 5622, the second coil loop of the anastomotic device is placed in the patient's small intestine. In embodiments, care is taken not to twist the small intestine when placing the coil. At step 5624, the delivery catheter is removed from the anastomotic device, the delivery device is pulled out of the patient's body, and the endoscope is removed from the patient's stomach. At step 5626, the first opening created by the enterotomy in the jejunum is closed with sutures or staples.

[0467] Fig.57A A human colon according to an embodiment of the present specification is shown, which can be resected to remove the diseased portion. Colon 5700 includes ascending colon 5702, transverse colon 5704, descending colon 5706, and sigmoid colon 5708 terminating in rectum 5710. Appendix 5712 is located at the proximal end of ascending colon 5702. Various tumors such as polyps 5714 or cancerous tumors 5716 may require resection of a portion of colon 5700 to remove the diseased portion. Once the diseased portion is resected, the two ends of the resected colon need to be fused together. In an embodiment, the anastomotic device of the present specification can be used to fuse the two ends of the colon resected at, for example, cutting lines 5718 and 5720, as shown, while maintaining the central flow path between the proximal and distal ends of the colon until the anastomosis is completed. Fig.57B A human colon 5720 is shown with a diseased portion 5722 removed and the resulting ends 5724, 5726 of the colon anastomosed together. The two ends 5724, 5726 fuse over a period of time to form an anastomosis 5728.

[0468] One known method of fusing the two ends of a resected colon involves suturing the two ends together. TM Powered staplers are widely used to sew the open ends of the resected colon together.

[0469] A known method of fusing the two ends of a resected colon also includes the use of an anastomotic device comprising a plunger end and a receiver end for fusing the two cut ends of the colon. The method comprises suturing the first and second ends of the resected colon and inserting a plunger-like device (through a hole formed in the patient's organ) into the first end of the purse-string suture using a handle with a control mechanism. Next, the purse-string is tightened around the plunger device. Then, a device similar to a plunger receiver is passed through the second end of the purse-string suture of the colon and attached to the plunger device protruding from the first end of the resected colon. The control mechanism on the handle is turned to snap the plunger end into the receiver until the top of the plunger is pressed against the receiver, causing the two ends to be pulled together and fused together. After a period of time, an anastomosis is formed between the first and second fused ends of the colon, allowing fluid to pass through. However, in this method, it is impossible for liquid to flow through the colon before the anastomosis is completed.

[0470] Therefore, the known methods of fusing the two ends of the resected colon do not first fuse the two ends of the colon and then achieve anastomosis. First cutting the anastomosis and then fusing the ends of the colon may cause massive bleeding and leakage in the colon. In addition, the known methods do not provide a mechanism by which the anastomotic device can be delivered to the patient's colon via the gastrointestinal tract without the need to form additional holes in the patient's organ wall. The circular stapler can be delivered to the patient's rectum, sigmoid colon, and descending colon through the gastrointestinal tract via the anus, but cannot be delivered to the colon through the gastrointestinal tract unless additional holes are provided for the transverse colon and ascending colon. In addition, the known methods of fusing the two ends of the resected colon do not provide a continuous fluid path through the ends of the colon throughout the fusion and anastomosis process.

[0471] In an embodiment, the present specification provides an anastomotic device, a delivery handle, and a method for fusing the two ends of a resected colon, such that the device is delivered to the resected ends of the colon via the patient's gastrointestinal tract without having to make additional cuts in the patient's organs. The method of the present specification allows fluid to pass through the ends of the colon throughout the fusion and anastomosis process while minimizing bleeding and leakage.

[0472] Fig.57C A human colon 5730 is shown in accordance with an embodiment of the present specification, wherein a diseased portion 5732 is removed and the resulting ends 5734, 5736 of the colon are anastomosed together using a magnetic compression stapling device 5735. The stapling device 5735 falls off and can be removed to pass naturally, leaving an intact anastomosis 5738. When the anastomosis is formed, the drainage mechanism 5737 of the stapling device 5735 provides immediate fluid opening from one end 5734 of the resected colon to the other end 5736 of the resected colon. In some embodiments, the anastomosis 5738 is fully formed and the stapling device 5735 falls off approximately 6-8 days after implantation.

[0473] Fig.57D Different types of anastomosis using a magnetic compression stapling device 5745 according to an embodiment of the present specification are shown. In various embodiments, an end-to-end colon anastomosis 5741, a side-to-side colon anastomosis 5743, and a side-to-end colon anastomosis 5747 can be formed.

[0474] Fig.57E A side-to-side colon anastomosis created using a magnetic compression stapling device in accordance with an embodiment of the present specification is shown. The stapling device 5755 is depicted as being placed 5751 and then implanted 5759 into the colon wall 5753 to create a side-to-side colon anastomosis between two segments of the colon 5750. In an embodiment, the stapling device 5755 includes a drainage mechanism 5756, such as a stent, to allow immediate fluid flow between adjacent lumens of the two segments of the colon while the anastomosis is being formed.

[0475] Fig.57F An anastomosis is shown created between a gallbladder 5760 and a duodenum 5762 using a magnetic compression anastomosis device 5765 in accordance with an embodiment of the present specification. The anastomosis device 5765 is depicted as being placed 5761 and then implanted 5769 into the duodenal wall 5767 to create an anastomosis between the gallbladder 5760 and the duodenum 5762. In an embodiment, the anastomosis device 5765 includes a drainage mechanism 5766, such as a stent, to allow immediate fluid flow between the adjacent lumens of the gallbladder 5760 and the duodenum 5762 while the anastomosis is formed.

[0476] Fig.5858 is a flow chart showing a method of fusing both ends of a resected colon according to one embodiment of the present specification. In step 5802, a diseased portion of a patient's colon is resected. In step 5804, the ends of the proximal colon segment and the distal colon segment are sutured using a purse-string suture technique, or the proximal colon segment and the distal colon segment are sutured together using a stapler. In step 5806, the proximal and distal purse-string suture / staple ends of the colon are pulled closer. In step 5808, a magnetic compression anastomosis device coupled to a delivery catheter of a delivery device is delivered through an enterotomy in the colon and positioned at one of the proximal and distal purse-string suture ends of the colon. In one embodiment, a catheter or endoscope is used to guide the delivery device through the patient's distal colon, rather than using an enterotomy to enter. In an embodiment, the anastomosis device includes at least a first coil loop and a second coil loop, the first coil loop and the second coil loop being made of SMA wire and threaded with a magnet and a spacer, and a drainage mechanism is located around or near an "S"-shaped connector connecting the first and second coil loops, as described in various embodiments / figures of the present specification. At step 5810, one end of a first coil loop of the anastomotic device is passed through the first lumen, through the first purse-string suture end of the colon. At step 5812, the end of the first coil loop of the anastomotic device extends from the first purse-string suture end to penetrate near the second purse-string suture end of the colon and extends into the second lumen. In the second lumen, the device is released from the delivery catheter, causing the first loop to coil within the second lumen of the colon. At step 5814, the anastomotic device is released from the delivery device, causing the second coil to curl within the first lumen, and the drainage mechanism extends between the first and second lumens of the colon. At step 5816, the first and second coils attract each other, generate pressure on the colon tissue, and fuse the tissue around the circumference of the coil to form an anastomosis. At step 5818, while the anastomosis is being performed, the drainage mechanism of the anastomotic device at least partially maintains a fluid path for flow between the first and second lumens of the colon and the proximal and distal ends. The drainage mechanism creates an initial or first opening that allows fluid flow and has a first diameter and a first surface area. Next, in step 5820, after a predetermined period of time, a compression anastomosis is formed between the two segments of the colon, and the anastomotic device is naturally discharged from the colon. After the anastomosis is formed, a second opening is formed in the colon, wherein the second opening has a second diameter and a second surface area; and wherein the first diameter and / or the first surface area is 5% to 95% of the second diameter and / or the second surface area. In one embodiment of the present specification, once the anastomotic device is released by the delivery device, the drainage mechanism is automatically placed, connecting the proximal and distal segments of the resected colon. In another embodiment, after the anastomotic device comprising an SMA wire and a magnet is placed at a predetermined position in the colon, the physician manually implants a separate drainage mechanism between the proximal and distal segments of the resected colon. The separate drainage mechanism can be a stent or a plastic catheter and is ideally placed through the tissue surrounded by the nitinol coil.

[0477] In one embodiment, the delivery device for delivering the anastomotic device comprises a handle, and the handle is provided with a control mechanism for guiding a user to correctly position the stent of the anastomotic device at a predetermined position in the patient's body. Fig.48A and Fig.48B , comprising a first and second set of loops of SMA wire, wherein the first and second set of loops are connected to an "S" shaped bridging segment, and wherein a stent made of a wire mesh and a biocompatible material covering the wire mesh material is placed around the bridging segment. In various embodiments, the handle control mechanism provides feedback to the user / physician that the first set of loops of the anastomotic device has been placed, then the first half of the stent / "S" shaped bridging segment has been placed, then the second half of the stent / "S" shaped bridging segment has been placed, and finally the second set of loops of the anastomotic device has been placed.

[0478] Fig.59 5900 is a block diagram of a handle of an anastomotic delivery device including a control mechanism according to one embodiment of the present specification. In one embodiment, the handle 5900 is coupled to an endoscope and a display device for inserting the anastomotic device into a predetermined position in the patient's body. The handle 5900 includes a shaft 5902 and a catheter lock 5904, which, when the catheter lock is opened, allows the shaft 5902 to move, resulting in the insertion of a catheter carrying the anastomotic device into the patient's organ. Once the catheter enters the predetermined tissue area, the catheter lock 5902 is locked to prevent the catheter from being pushed inside ( Fig.51A 5113) from the outer shaft / barrel of the coaxial catheter ( Fig.51A 5120) is accidentally pushed out. The handle also includes a stent placement hub 5906 coupled to the stent lock, and when the stent lock is opened, the stent placement hub 5906 is capable of moving the shaft 5902 upward to a first pre-marked position 5908 on the handle to place the first flange of the stent covering the connecting member of the anastomotic device. In an embodiment, the stent placement hub 5906 and the catheter lock 5902 are separate components. In other embodiments, the stent placement hub 5906 and the catheter lock are the same structure. Therefore, the stent placement hub 5906 aligned with the first pre-marked position 5908 provides feedback to the user that the first half of the stent / "S" shaped bridge segment has been placed. The catheter lock 5904 can be opened again, and the shaft 5902 can be adjusted to ensure that the second set of rings or distal rings are placed at a predetermined position within the organ. In order to place the second flange of the stent covering the connecting member of the anastomotic device, the stent placement hub 5906 is unlocked and the shaft 5902 is moved upward to the second pre-marked position 5910 on the handle. The stent placement hub 5904 aligned with the second pre-marked location 5910 provides feedback to the user that the second half of the stent / "S" shaped bridge segment has been placed.

[0479] Fig.60is a flow chart listing the steps in a method for producing a side-to-side anastomosis using a magnetic compression anastomosis device according to an embodiment of the present specification. In step 6002, a first intestinal cavity is entered endoscopically or surgically. In step 6004, a delivery catheter connected to the anastomosis device enters the first lumen and enters the second lumen through the intestinal wall. In step 6006, the distal ring of the first coil loop is placed in the second lumen and the catheter is withdrawn into the first lumen. In step 6008, the proximal ring of the second coil loop is placed in the first lumen, and an S-shaped connector with a drainage mechanism located thereon is placed, passing through the intestinal wall so that the first lumen is in fluid communication with the second lumen. In step 6010, the catheter is removed from the patient's body. In step 6012, the compression anastomosis is formed within 2-20 days, and the magnetic anastomosis device passes naturally.

[0480] Fig.61 is a flow chart listing the steps in a method of producing a side-to-side anastomosis using a magnetic compression stapling device according to an embodiment of the present specification. In step 6102, the diseased segment of intestine is resected and the ends of the resected intestine are closed using sutures or staples. In step 6104, a first lumen within a first segment of the remaining intestine is accessed endoscopically or surgically. In step 62, a delivery catheter with an anastomotic device attached thereto enters the first lumen and enters a second lumen within a second segment of the remaining intestine through the intestinal wall near the suture or staple line, the second segment being separate and distinct from the first segment of the remaining intestine, near its suture or staple line. In step 6108, a distal ring of a first coil loop is placed in the second lumen and the catheter is withdrawn into the first lumen. In step 6110, a proximal ring of the coil is placed in the first lumen and an S-shaped connector with a drainage mechanism located thereon is placed, through the intestinal wall, so that the first lumen is in fluid communication with the second lumen. In step 6112, the catheter is withdrawn from the patient. At step 6114, a compression anastomosis is formed within 2-20 days and the magnetic anastomotic device passes naturally.

[0481] Fig.62is a flow chart listing the steps in a method for producing an anastomosis with immediate fluid patency and delayed fluid patency using a magnetic compression anastomosis device according to an embodiment of the present specification. In step 6202, a magnetic anastomosis device with a drainage mechanism is placed on the walls of two adjacent organs, with the distal loop of the coil of the device in a first lumen of the first organ and the proximal loop in a second lumen of the second organ. In step 6404, an S-shaped connector connecting the two coil loops and containing an inflatable drainage mechanism located thereon is passed from the first lumen to the second lumen. In step 6206, the inflatable drainage mechanism is inflated to produce a first fluid connection between the first lumen and the second lumen, wherein the first fluid connection has a first diameter D1. In step 6208, a compression anastomosis is formed, and the magnetic anastomosis device is naturally passed to produce a second fluid connection between the first lumen and the second lumen, wherein the second fluid connection has a second diameter D2, and wherein D2 is at least 5% larger than D1.

[0482] Fig.63 is a flowchart listing the steps in a method for producing an anastomosis with immediate fluid patency and delayed fluid patency using a magnetic compression anastomosis device according to other embodiments of the present specification. In step 6302, a magnetic anastomosis device with a drainage mechanism is placed on the walls of two adjacent organs, with the distal loop of the coil of the device in the first lumen of the first organ and the proximal loop in the second lumen of the second organ. In step 6304, an S-shaped connector connecting the two coil loops and containing an inflatable drainage mechanism located thereon is passed from the first lumen to the second lumen. In step 6306, the inflatable drainage mechanism is inflated to produce a first fluid connection between the first lumen and the second lumen, wherein the first fluid connection has a first cross-sectional area A1. In step 6308, a compression anastomosis is formed, and the magnetic anastomosis device is naturally passed to produce a second fluid connection between the first lumen and the second lumen, wherein the second fluid connection has a second cross-sectional area A2, and wherein A2 is at least 5% larger than A1.

[0483] The above examples are merely illustrations of many applications of the system of the present specification. Although only a few embodiments of the present invention are described herein, it should be understood that the present invention may be implemented in many other specific forms without departing from the spirit or scope of the present invention. Therefore, the present examples and embodiments are considered to be illustrative rather than restrictive, and the present invention may be modified within the scope of the appended claims.

Claims

1. An anastomotic device, comprising: a wire, wherein the wire has a first state and a second state, wherein in the first state the wire has a substantially linear form, wherein in the second state the wire forms a coil having at least a first loop and a second loop, and wherein the wire is adapted to transition from the first state to the second state when exposed to a temperature greater than a threshold value, and wherein the first loop is connected to the second loop by a bridging segment, the bridging segment comprising a predetermined length of the wire such that the wire is capable of coiling in a first direction into the first loop and in an opposite second direction into the second loop when changing from the first state to the second state; a plurality of magnets positioned on the first ring and the second ring, wherein each of the plurality of magnets has an inner cavity through which the wire extends, wherein in each of the first ring and the second ring, a portion of adjacent magnets of the plurality of magnets are configured not to be connected to each other, and wherein a portion of the plurality of magnets in the first ring is configured to attract a portion of the plurality of magnets in the second ring.

2. The anastomotic device according to claim 1 further includes a stent positioned on the bridging segment, wherein the stent is capable of expanding from a first contracted state to a second expanded state, wherein the stent has an inner cavity through which the bridging segment extends.

3. The anastomotic device according to claim 2, wherein the bridge section on which the stent is located is not coiled.

4. The anastomotic device according to claim 1, wherein the tip of the metal wire is coupled to a cautery tip made of a ceramic material for piercing body tissue.

5. The anastomotic device according to claim 1, wherein in the second state, the metal wire forms a coil having at least four coil loops.

6. The anastomotic device according to claim 1, wherein before positioning the anastomotic device in a body cavity through a catheter, the anastomotic device is packaged in a shape-setting mold, the shape-setting mold maintaining the wire in the second state, wherein the wire forms a coil having a first proximal end and a second distal end, the first proximal end comprising a threaded connector for coupling to the catheter, the second distal end having a tip for piercing adjacent body tissue, and wherein the first proximal end and the second distal end are bent 15° to 20° toward the center of the coil ring of the coil so that the catheter can leave the endoscopic lifter at an angle of at least 30° during positioning the anastomotic device in the body cavity.

7. The anastomotic device of claim 1, wherein the metal wire is transformed from the first state to the second state by exposing the metal wire to a temperature above 37 degrees Celsius.

8. The anastomotic device according to claim 1, wherein the anastomotic device is used to form an anastomosis between a gallbladder and a small intestine of a patient to treat one of diabetes, obesity and metabolic syndrome.

9. The anastomotic device according to claim 1, wherein the anastomotic device is used to form an anastomosis between a patient's gallbladder and small intestine to treat one of gallbladder motility abnormalities, gallbladder dyskinesia, biliary dyskinesia, and biliary pancreatitis.

10. The anastomotic device according to claim 1, wherein when the metal wire changes from the first state to the second state, the bridging segment is coiled into an "S" shape.

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