Magnetic stapling devices and delivery systems

Abstract

The anastomotic device includes a magnet coupled to a wire that changes shape from a straight wire to a coil when deployed in the body. The coil applies a compressive force on the tissue layer stuck between the loops of the coil. The compressive force is enhanced by the attractive force between the magnets coupled to the adjacent loops of the coil, and causes the coil to cut through the tissue layer to form an anastomosis. One end of the wire is preferably provided with a connecting member, such as a screw or a nut, for connection to the delivery device.

Description

[0001] This application is a divisional application of the invention patent application with application date of May 25, 2017, application number 201780058957.3, and invention name “Magnetic Anastomosis Device and Delivery System”.

[0002] Cross-references

[0003] This specification relies on U.S. Provisional Patent Application No. 62 / 425,951, entitled “Anastomosis Device and Delivery System,” filed on November 23, 2016, U.S. Provisional Patent Application No. 62 / 408,795, entitled “Anastomosis Device and Delivery System,” filed on October 16, 2016, and U.S. Provisional Patent Application No. 62 / 366,185, entitled “Anastomosis Device and Delivery System,” filed on July 25, 2016, all of which are incorporated herein by reference in their entirety. Technical Field

[0004] The present disclosure relates to forming anastomoses in the human body and, more particularly, to devices for use in an efficient anastomotic delivery system for placing a device at a desired location in the human body. Background Art

[0005] The number of people diagnosed with gallstones is increasing all over the world. Every year, more than one million Americans are diagnosed with gallstones, and another 200 million have already suffered from the disease. This disease can be treated by performing a cholecystectomy, which involves a surgical procedure to remove the patient's gallbladder. Usually, the process is performed with the aid of a laparoscope. About 12 million laparoscopic procedures are performed in the United States each year, with a mortality rate of 0.22% to 0.4%. Sometimes, the process can lead to morbidity, such as trocar / veress needle injury, bleeding, post-cholecystectomy syndrome, common bile duct (CBD) injury or stenosis, wound infection or abscess, intestinal obstruction, gallstone spillage, and deep vein thrombosis. By performing a cholecystogastrostomy, a cholecystoduodenostomy, or a cholecystojejunostomy (which allows gallbladder drainage and also allows the removal of gallstones), this morbidity of endoscopy can be reduced.

[0006] Pancreatic pseudocysts are serious complications of pancreatitis and cause fluid to collect around the pancreas. The fluid in the cyst is usually pancreatic juice that has leaked out of the damaged pancreatic duct. Pancreatic pseudocysts occur after acute pancreatitis or chronic pancreatitis. In some patients, pseudocysts develop soon after suffering from acute pancreatitis. Usually, patients will develop symptoms weeks or months after recovering from acute or chronic pancreatitis. Common symptoms for patients are abdominal pain, bloating, poor digestion of food, or complications related to the pseudocyst, such as infection of the pseudocyst with a pancreatic abscess, blood flow into the pseudocyst, or parts of the intestine being blocked by the pseudocyst.

[0007] Typically, this condition can be treated by laparoscopic or endoscopic anastomotic bypass, which facilitates transgastric or transduodenal endoscopic drainage of pancreatic pseudocysts greater than 6 cm in size (greater than 70% of the fluid contents adhere to the gastric or intestinal wall). There are many other benign and malignant indications, such as cancer obstruction and treatment of gastroparesis, diabetes, and obesity, in which gastro-enteric or intestinal-enteric anastomosis is desirable. Most of these anastomoses are performed surgically.

[0008] Prior art devices for forming anastomosis typically include piercing tips that are dangerous and can cause damage to adjacent organs. Surgical instruments typically use gripping mechanisms that are difficult to operate. Further, the operation of some prior art surgical instruments requires two punctures, which increases the possibility of leakage from the puncture site through the grasper. Also, some prior art devices can only be placed near the adjacent wall, and there is no pressure sufficient to cause damage and necrosis of the intermediate tissue to thereby form a sufficiently large anastomosis that will remain for a long time to provide adequate drainage. Additional interference is required to form a large opening. Although stents made of materials such as shape memory alloys (SMA) (which are inserted into the human body through an endoscope to form anastomosis and drain pancreatic pseudocysts) are known, the use of these devices requires many interventions to place and remove the stents and to solve frequent blockages caused by debris in the pancreatic fluid.

[0009] In addition, prior art magnetic anastomosis methods typically require the use of two separate mating devices that are deployed in two adjacent organs, respectively. 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 pulls the two devices together, capturing and squeezing portions of the two organ walls between the devices, ultimately causing tissue necrosis and the formation of an anastomosis. The devices typically have a deployed configuration of a single-loop polygonal shape with no out-of-plane curved portions. The devices typically include additional features that assist in forming the desired deployed shape, such as an exoskeleton and guides and opening / closing elements.

[0010] Therefore, what is needed is an efficient and small anastomotic device that can be easily delivered to the human body without the need for a gripper. There is also a need for an anastomotic device that can be deployed by a single operator using a single endoscopic process to cause a single puncture in the organ wall to deliver the entire device. It is also desirable to use a puncture mechanism that is separate from the anastomotic device and does not remain in the body with the anastomotic device to reduce the possibility of damage to internal organs. Further, there is a need for an anastomotic device that can apply a sufficiently high extrusion force on the organ wall to form an anastomosis between the organs, and still maintain a sufficiently small profile to be delivered by 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 force to correct orientation and positioning in the human body, and does not require accurate manual positioning of two separate extrusion elements. There is also a need for an anastomotic device that can connect two hollow organs without the need to allow an endoscope or laparoscope to advance into the two organs, and the device can be intervened by endoscopic or laparoscopic intervention in the first of the two organs, while the second organ is intervened by the device delivery catheter. Summary of the invention

[0011] The present specification discloses an anastomosis device, which includes a plurality of magnets connected to a wire, wherein the wire includes a shape memory alloy (SMA), wherein the wire is suitable for changing its shape into a coil when deployed in the body, wherein the coil is suitable for applying a squeezing force on a tissue layer stuck between coil loops, and wherein the plurality of magnets are suitable for providing a squeezing force to adjacent loops of the coil, thereby further causing the coil to cut through the tissue layer and form an anastomosis; wherein at least one end of the wire includes a connecting device for connecting to a delivery device.

[0012] Optionally, the wire diameter is 0.1 mm to 10 mm and the wire length is 1 cm to 250 cm.

[0013] Optionally, the connecting device is one of a nut and a screw.

[0014] Optionally, the length of the wire is 440 to 460 mm.

[0015] Optionally, the SMA wire is a Nitinol wire.

[0016] Optionally, the magnets are positioned such that a repulsive force between adjacent magnets on the same coil causes said adjacent magnets to maintain a predetermined distance between said adjacent magnets.

[0017] Optionally, the magnet is a rare earth magnet covered with at least one of gold, nickel and titanium.

[0018] Optionally, in the coiled state, the maximum cross-sectional diameter of the SMA wire ranges from 5 mm to 50 mm.

[0019] Optionally, each magnet has a maximum cross-sectional length of 0.2mm to 7mm and / or a tensile force of 0.1 lb to 4 lb.

[0020] Optionally, the compression force is 0.1 to 100 N and the associated pressure applied to the tissue layer is 0.15 psi-145 psi (0.001 to 1 MPa);

[0021] Optionally, the pulling force between any two sequentially placed magnets on the wire is about 2.318N.

[0022] Optionally, the length, inner diameter and outer diameter of each magnet are 3 mm, 0.66 mm and 3 mm respectively.

[0023] Optionally, the shape of the anastomosis formed by using the SMA wire and the magnet is determined by the shape of the coiled SMA wire.

[0024] Optionally, at least 50% of adjacent magnets on each turn of the coil are arranged with the same poles facing each other, thereby forming a repulsive force between two adjacent magnets in a single turn of the coil.

[0025] Optionally, the two adjacent magnets on a single loop of the coil are separated by a distance greater than the length of each of the two adjacent magnets.

[0026] Optionally, the two adjacent magnets on a single loop of the coil are separated by a distance that is less than the length of each of the two adjacent magnets.

[0027] The present specification also discloses a delivery device for deploying an anastomotic device at a predetermined position in the body, the anastomotic device comprising a plurality of magnets connected to a shape memory alloy (SMA) wire, which can change its shape from a non-coiled wire to a coil when deployed in the body, the delivery device comprising: a delivery catheter for pushing the device into a channel of an endoscope and pushing it out through the end of the endoscope at the said position, wherein the delivery catheter comprises a mechanism for connecting to the anastomotic device, and wherein the mechanism is suitable for opening to release the anastomotic device at the deployment position.

[0028] Optionally, the delivery device further comprises a non-cautery needle comprising a lumen for carrying the stapling device, the needle being delivered to the location via an endoscope, wherein the needle is adapted to penetrate tissue for deployment of the stapling device therein.

[0029] Optionally, the delivery device further comprises a cautery, wherein the cautery needle is adapted to be delivered to the location via a channel of the endoscope with the stapling device, and wherein the needle is adapted to penetrate tissue for accessing a lumen of such tissue and deploying the stapling device therein.

[0030] Optionally, the non-crimped filaments are substantially planar.

[0031] Optionally, the non-crimped filaments comprise waves.

[0032] The present specification also discloses a method for forming an anastomosis by using an anastomosis device, the anastomosis device comprising a plurality of magnets coupled to a shape memory alloy (SMA) wire, the wire being adapted to change shape from a non-coiled wire to a coil when deployed in a body, wherein the coil is adapted to apply a squeezing force on a tissue layer stuck between coil loops, wherein the plurality of magnets are adapted to enhance the squeezing force applied by adjacent loops of the coil, and wherein the squeezing force causes one or more coils and magnets to cut through the tissue layer, thereby forming an anastomosis, the method comprising: identifying a deployment location having adjacent walls of two organs to be anastomosed; delivering the SMA wire coupled to the magnet to the identified location; puncturing the adjacent organ wall at the deployment location and deploying the SMA wire, wherein; squeezing adjacent organ wall tissue stuck between the loops of the coiled wire, wherein body heat causes the SMA wire to curl, and wherein the squeezing force between the plurality of magnets causes the curled structure to apply greater pressure to the tissue stuck between the loops of the coiled wire; cutting the adjacent tissue stuck between the loops of the coiled wire to form an anastomosis; and removing the SMA coil after a stable anastomosis is formed.

[0033] Optionally, the magnet causing the compressive force magnet is positioned in an adjacent loop of the SMA coil.

[0034] Optionally, the compression force between the coils increases over time.

[0035] Optionally, at least two of the plurality of magnets are positioned on at least one of the coil loops, and wherein the at least two magnets are arranged with opposite poles facing each other, thereby forming an attractive force between the at least two magnets on at least one loop of the coil, and wherein the anastomosis device includes a non-ferromagnetic spacer positioned on at least one loop between the at least two magnets, thereby preventing the at least two magnets from attaching to each other.

[0036] Optionally, the non-ferromagnetic space has a length, and wherein the length is adapted to keep the attraction between the at least two magnets below a bending force of the coil, thereby not preventing the coil from changing from a pre-curling shape to a coil shape after deployment.

[0037] Optionally, the time required to form the anastomosis is from one to fourteen days.

[0038] The present specification also discloses a method for forming an anastomosis between two adjacent body tissues, comprising: positioning an anastomosis device in a body cavity near at least one of the adjacent body tissues via a catheter, wherein the anastomosis device comprises: a wire, wherein the wire has a first state and a second state, wherein in the first state, the wire has a substantially straight 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 change from the first state to the second state when exposed to a temperature greater than a critical value; and a plurality of magnets positioned on the wire, wherein each of the plurality of magnets has an inner cavity through which the wire extends, wherein in each of the first loop and the second loop, a portion of adjacent magnets of the plurality of magnets is configured not to be attached to each other, and wherein a portion of the plurality of magnets in the first loop is configured to attract a portion of the plurality of magnets in the second loop; puncturing the adjacent body tissues and positioning the anastomosis device through the hole formed by the puncture; and releasing the anastomosis device so that, when it changes from the first state to the second state, tissue between the two adjacent body tissues is stuck between the first loop and the second loop, thereby being squeezed and achieving anastomosis.

[0039] Optionally, the anastomosis device further includes a non-ferromagnetic spacer positioned between adjacent magnets in the plurality of magnets. Optionally, each of the non-ferromagnetic spacers has a length sufficient to keep the attraction between the opposite magnetic poles of the adjacent magnets below the coil bending force. Optionally, in the second state, the maximum cross-sectional diameter of the first loop and the second loop is 5mm to 50mm. Optionally, each of the plurality of magnets has a maximum cross-sectional length or diameter of 0.2mm to 7mm and a pulling force of 0.01lb to 4lb (0.04-17.8N). Optionally, in the first loop and in the second loop, at least 50% of the adjacent magnets in the plurality of magnets are arranged to face each other with the same magnetic poles, thereby forming a repulsive force between the adjacent magnets in the first loop and a repulsive force between the adjacent magnets in the second loop of the coil.

[0040] Optionally, at least one end of the wire is connected to the delivery device. Optionally, the wire includes a shape memory alloy. Optionally, the critical value is 20 degrees Celsius. Optionally, the coil has at least one loop close to the first loop and at least one loop away from the second loop. Optionally, each of the plurality of magnets is cylindrical and is a rare earth magnet covered by at least one of gold, nickel, Teflon, Parylene, copper, zinc, silicone, epoxy and titanium. Optionally, the method further includes, before releasing the anastomotic device, heating the anastomotic device by passing an electric current through the anastomotic device to facilitate the transition from the first state to the second state. Optionally, the wire diameter is 0.1mm to 10mm and the wire length is 1cm to 250cm. Optionally, the wire diameter is 0.1mm to 6mm and has a maximum strain of less than 10% in the first state, and wherein, in the second state, the maximum cross-sectional size of the first loop and the second loop is 5mm to 60mm.

[0041] Optionally, adjacent body tissues include gallbladder and duodenum, and the maximum diameter of the first loop and the second loop is less than or equal to 30mm. Optionally, adjacent body tissues include pancreatic tissue or biliary tissue and the maximum diameter of the first loop and the second loop is greater than or equal to 5mm. Optionally, the diameter of the silk thread is less than 0.5mm, and the maximum cross-sectional dimension of the first loop and the second loop is less than or equal to 15mm. Optionally, the diameter of the silk thread is 0.5mm to 1.0mm and the maximum cross-sectional dimension of the first loop and the second loop is 10mm to 25mm. Optionally, the diameter of the silk thread is greater than 1mm, and the size of the first loop and the second loop is greater than 20mm. Optionally, the first loop and the second loop have at least one of a circular shape, a polygonal shape, and a star shape with four or more points. Optionally, a part of the adjacent magnets in the multiple magnets on the same loop is configured to repel each other.

[0042] Optionally, the wire is heated by passing an electric current through it to assist in coil formation, wherein the increase in the wire temperature causes the wire to assume the coil shape due to its shape memory properties.

[0043] Optionally, the transition temperature of the filament is greater than 37° C. Optionally, at two or more points on opposite sides of at least one of the first loop and the second loop, the applied pressure is greater than or equal to 0.3 psi.

[0044] The present specification also discloses a method for forming an anastomosis between two adjacent body tissues, comprising: positioning an anastomosis device in a body cavity near at least one of the adjacent body tissues, wherein the anastomosis device comprises: a wire, wherein the wire has a first state and a second state, wherein in the first state, the wire has a substantially straight 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 20 degrees Celsius; and a plurality of magnets positioned on the wire, wherein the plurality of magnets Each having an inner cavity through which the wire extends, wherein, in each of the first and second loops, a portion of adjacent magnets of the plurality of magnets is configured not to be attached to each other, and wherein a portion of the plurality of magnets in the first loop is configured to attract a portion of the plurality of magnets in the second loop; puncturing adjacent body tissues and positioning the anastomosis device through the hole formed by the puncture; and releasing the anastomosis device so that, when it is transformed from the first state to the second state, the tissue between the two adjacent body tissues is stuck between the first loop and the second loop, thereby being squeezed with a pressure of at least 1 psi and achieving anastomosis. Optionally, the pressure is at least 100 mm Hg (1.93 psi). Optionally, the pressure is greater than 10 mm Hg (0.19 psi) but less than or equal to 7,500 mm Hg (145 psi), and includes every integer and fractional value within this range.

[0045] Optionally, at two or more points on the opposite side of at least one of the first and second loops, the pressure applied is greater than or equal to 0.3psi. Optionally, the anastomotic device further includes a non-ferromagnetic spacer positioned between adjacent magnets in the plurality of magnets. Optionally, the first and second loops have at least one of a circular shape, a polygonal shape, and a star shape with four or more points. Optionally, each of the plurality of magnets has a maximum cross-sectional length of 0.2mm to 7mm and a pulling force of 0.01lb to 4lb (0.04-17.8N). Optionally, in the first loop and in the second loop, at least 50% of the adjacent magnets in the plurality of magnets are arranged to face each other with the same magnetic poles, thereby forming a repulsive force between the adjacent magnets in the second loop and the first loop of the coil. Optionally, the coil has at least one loop close to the first loop and at least one loop away from the second loop. Optionally, the diameter of the wire is 0.1 mm to 10 mm and the length of the wire is 1 cm to 250 cm, and wherein in the second state, the maximum cross-sectional dimension of the first loop and the second loop is 5 mm to 60 mm.

[0046] The present specification also discloses a magnet assembly for a magnetic anastomosis device, the magnetic anastomosis device is used to form an anastomosis between two body walls, the magnet assembly comprising: a slender member, such as a solid wire without an inner channel or lumen, having a proximal end and a distal end and a plurality of magnetic members arranged above the slender member. The magnet assembly can be operated between a delivery (pre-deployment) configuration and a deployed configuration, the slender member extending generally straight in the delivery configuration, the slender member forming a spiral or coil shape in the deployed configuration, wherein the proximal end and the distal end of the slender member are not adjacent to each other and are separated from each other by a distance equal to or greater than the size of one of the plurality of magnetic members.

[0047] The above and other embodiments are described in more detail with reference to the accompanying drawings and in detail as follows. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] These and other features and advantages of the present invention will be better understood with reference to the detailed description taken in conjunction with the accompanying drawings:

[0049] Figure 1 A straight shape memory alloy (SMA) wire is shown curled in a human body according to an embodiment of the present specification;

[0050] Figure 2 shows a plurality of magnets passing through a loop of SMA wire according to an embodiment of the present specification;

[0051] Figure 3A A gallbladder with gallstones is shown, which is punctured using an endoscope for placement of SMA wires to form an anastomosis according to an embodiment of the present specification;

[0052] Figure 3B The SMA coil according to the embodiment of the present specification is shown. Figure 3A The anastomosis between the gallbladder and duodenum is shown;

[0053] Figure 3C FIG. 2 shows an SMA coil penetrated by a magnet according to another embodiment of the present specification, which forms an anastomosis between the gallbladder and the duodenum;

[0054] Figure 3D According to the embodiment of this specification, Figure 3C A close up view of the SMA coil of the magnet shown;

[0055] Figure 4A shows the first stage of the anastomosis process according to an embodiment of the present specification;

[0056] Figure 4B The embodiment according to this specification is shown Figure 4A The second stage of the anastomosis process is shown;

[0057] Figure 4C The embodiment according to this specification is shown Figure 4A and 4B The third stage of the anastomosis process is shown;

[0058] Figure 4D The example according to the embodiment of this specification is shown as Figure 4A , 4B and 4C , the fourth and final stage of the anastomosis process, anastomosis formation;

[0059] Figure 5 A table showing exemplary dimensions of SMA wires for forming anastomoses according to embodiments of the present specification;

[0060] Figure 6 A square SMA coil is shown coupled with a magnet for forming an anastomosis according to an embodiment of the present specification;

[0061] Fig. 7A A hexagonal SMA coil is shown coupled with a magnet for forming an anastomosis according to an embodiment of the present specification;

[0062] Figure 7B The embodiment according to this specification is shown Fig. 7A Exemplary dimensions of the hexagonal SMA coil shown;

[0063] Figure 7C A first decagonal SMA coil is shown coupled with a magnet for forming an anastomosis according to an embodiment of the present specification;

[0064] Fig.7D A second decagonal SMA coil is shown coupled to a magnet for forming an anastomosis according to another embodiment of the present specification;

[0065] Fig. 7E shows exemplary dimensions of a decagonal SMA coil coupled with a magnet for forming a conformation according to an embodiment of the present specification;

[0066] Figure 7F A dodecagonal SMA coil is shown coupled with a magnet for forming an anastomosis according to an embodiment of the present specification;

[0067] Figure 7G shows exemplary dimensions of a hexagonal SMA coil according to an embodiment of the present specification;

[0068] Figure 7H shows exemplary dimensions of an octagonal SMA coil according to an embodiment of the present specification;

[0069] Fig.7I shows exemplary dimensions of a decagonal SMA coil according to an embodiment of the present specification;

[0070] Figure 7J shows exemplary dimensions of a dodecagonal SMA coil according to an embodiment of the present specification;

[0071] Figure 7K shows exemplary dimensions of a tetradecagonal SMA coil according to an embodiment of the present specification;

[0072] Figure 8 The process of forming anastomosis by using an SMA coil according to an embodiment of the present specification is shown;

[0073] Fig. 9A shows two organ walls squeezed between loops of an SMA coil according to an embodiment of the present specification;

[0074] Fig. 9B shows two organ walls squeezed between loops of an SMA coil, the squeezing force being enhanced by the use of magnets, according to an embodiment of the present specification;

[0075] Fig.10 shows the walls of two organs squeezed between loops of an SMA coil and a magnet according to an embodiment of the present specification;

[0076] Fig.11 A plurality of magnets are shown coupled to a loop of an SMA coil for forming an anastomosis according to an embodiment of the present specification;

[0077] Fig.12 A plurality of magnets are shown coupled to a loop of an SMA coil for forming an anastomosis according to another embodiment of the present specification;

[0078] Fig.13 shows the placement of magnets coupled to adjacent loops of SMA coils for forming a conformation according to an embodiment of the present specification;

[0079] Fig.14A An exemplary SMA wire for forming an anastomosis prior to deployment in a body is shown coupled with a magnet in accordance with an embodiment of the present specification;

[0080] Fig. 14B The embodiment of the present specification is in the middle stage of deployment. Fig.14A An exemplary SMA wire coupled to a magnet is shown;

[0081] Fig. 14C An exemplary SMA wire for forming an anastomosis after being deployed in the body according to an embodiment of the present specification is shown. Fig.14A The magnet coupling shown;

[0082] Fig.14Dshows an exemplary SMA wire for forming an anastomosis prior to deployment in a body, coupled with a magnet, according to another embodiment of the present specification;

[0083] Fig.14E The embodiment of the present specification is in the middle stage of deployment. Fig.14D An exemplary SMA wire coupled to a magnet is shown;

[0084] Fig.14F An exemplary SMA wire for forming an anastomosis after being deployed in the body according to an embodiment of the present specification is shown. Fig.14D The magnet coupling shown;

[0085] Fig.15A shows an exemplary SMA wire for forming an anastomosis prior to deployment in a body, coupled with a magnet, according to another embodiment of the present specification;

[0086] Fig. 15B The embodiment of the present specification is in the middle stage of deployment. Fig.15A An exemplary SMA wire coupled to a magnet is shown;

[0087] Fig. 15C An exemplary SMA wire for forming an anastomosis after being deployed in the body according to an embodiment of the present specification is shown. Fig.15A The magnet coupling shown;

[0088] Fig.15D shows an exemplary SMA wire for forming an anastomosis prior to deployment in a body, coupled with a magnet, according to yet another embodiment of the present specification;

[0089] Fig.15E The embodiment of the present specification is in the middle stage of deployment. Fig.15D An exemplary SMA wire coupled to a magnet is shown;

[0090] Fig.15F An exemplary SMA wire for forming an anastomosis after being deployed in the body according to an embodiment of the present specification is shown. Fig.15D The magnet coupling shown;

[0091] Figure 15G is a diagram according to an embodiment of the present specification, which shows the pressure applied to body tissue by the loops of the coil as the distance between the magnets on the coil decreases;

[0092] Fig.16A An exemplary circular SMA coil for forming anastomosis according to an embodiment of the present specification is shown;

[0093] Fig. 16BAn exemplary circular shaped SMA coil with a cutting edge for forming an anastomosis according to an embodiment of the present specification is shown;

[0094] Fig. 16C An exemplary square SMA coil for forming an anastomosis according to an embodiment of the present specification is shown;

[0095] Fig.17A An exemplary device according to an embodiment of the present specification is shown, which includes a circular magnet coupled to an SMA coil for forming an anastomosis;

[0096] Fig. 17B An exemplary apparatus according to an embodiment of the present specification is shown, comprising a circular magnet coupled to an SMA coil for forming an anastomosis, wherein at least one of the magnets comprises a cutting edge;

[0097] Fig. 17C An exemplary device according to an embodiment of the present specification is shown, comprising a square magnet coupled to an SMA coil having a serrated edge for forming an anastomosis;

[0098] Fig.17D An exemplary device according to another embodiment of the present specification is shown, which includes a square magnet coupled with an SMA coil for forming an anastomosis;

[0099] Fig.17E An exemplary apparatus according to an embodiment of the present specification is shown, comprising square magnets coupled to an SMA coil for forming an anastomosis, wherein at least one of the magnets comprises a cutting edge;

[0100] Fig.17F shows a cross-sectional view of an exemplary device according to an embodiment of the present specification, comprising a circular magnet coupled to an SMA coil for forming an anastomosis, wherein the magnet comprises a protruding edge to facilitate cutting;

[0101] Figure 17G shows a cross-sectional view of an exemplary device according to an embodiment of the present specification, comprising a square magnet coupled to an SMA coil for forming anastomosis, wherein the magnet comprises a protruding edge to facilitate cutting;

[0102] Fig.18A A first configuration of a plurality of magnets arranged around a loop of an SMA coil is shown for forming an anastomosis according to an embodiment of the present specification;

[0103] Fig.18B shows a second configuration of a plurality of magnets arranged around a loop of an SMA coil for forming an anastomosis according to another embodiment of the present specification;

[0104] Fig. 18Cshows a third configuration of a plurality of magnets arranged around a loop of an SMA coil and separated by non-ferromagnetic spacers for forming an anastomosis in accordance with an embodiment of the present specification;

[0105] Fig.18D shows a fourth configuration of a plurality of magnets arranged around a loop of an SMA coil and separated by non-ferromagnetic spacers for forming an anastomosis according to another embodiment of the present specification;

[0106] Fig.18E shows a fifth configuration of magnets surrounding a loop of an SMA coil for forming an anastomosis in accordance with an embodiment of the present specification;

[0107] Fig.18F shows a sixth configuration of magnets surrounding a loop of an SMA coil for forming an anastomosis in accordance with an embodiment of the present specification;

[0108] Fig.19A A first step of forming an anastomosis between two organs in a human body according to an embodiment of the present specification is shown;

[0109] Fig.19B A second step of forming an anastomosis between two organs in a human body according to an embodiment of the present specification is shown;

[0110] Fig.19C A third step of forming an anastomosis between two organs in a human body according to an embodiment of the present specification is shown;

[0111] Fig. 20A A non-ablative needle for delivering an SMA coil in the body is shown according to an embodiment of the present specification;

[0112] Fig. 20B The embodiment according to this specification is shown Fig. 20A The handle of the non-cautery needle shown;

[0113] Fig.21 An ablation needle device according to an embodiment of the present specification is shown for delivering an SMA coil in the body via an endoscope;

[0114] Fig. 22 An ablation needle device according to an embodiment of the present specification is shown, which is used to deliver an SMA coil into the body via an endoscope with the assistance of a guide wire;

[0115] Fig.23A A release mechanism for releasing an SMA coil from a delivery catheter according to an embodiment of the present specification is shown;

[0116] Fig. 23B According to the embodiment of this specification, Fig.23AThe SMA coil released by the delivery catheter is shown;

[0117] Fig.24A A release mechanism for releasing an SMA coil from a delivery catheter according to another embodiment of the present specification is shown;

[0118] Fig. 24B According to the embodiment of this specification, Fig.24A The SMA coil released by the delivery catheter is shown;

[0119] Fig.25 is a flow chart showing the steps of forming an anastomosis by using an anastomosis instrument according to an embodiment of the present specification;

[0120] Fig.26A shows a first view of an exemplary device for forming an anastomosis in a pre-crimping configuration according to an embodiment of the present specification;

[0121] Fig.26B Shown in the pre-curling configuration Fig.26A a second view of a device for forming an anastomosis;

[0122] Fig.26C Shown in the pre-curling configuration Fig.26A A third view of a device for forming an anastomosis;

[0123] Fig.26D Shown in a curled configuration Fig.26A A side view of a device for forming an anastomosis;

[0124] Fig.26E Shown in a curled configuration Fig.26A An axial view of a device for forming an anastomosis;

[0125] Fig.26F A first exemplary device for forming an anastomosis in a deployed conical coil configuration is shown according to one embodiment of the present specification;

[0126] Figure 26G A second exemplary device for forming an anastomosis in a deployed conical coil configuration is shown according to one embodiment of the present specification;

[0127] Fig.26H An embodiment of a device for forming an anastomosis is shown in a post-deployment coil configuration and includes a single flange attached to one end of the coil;

[0128] Fig.26I Another embodiment of a device for forming an anastomosis is shown in a post-deployment coil configuration and includes a single flange attached to one end of the coil;

[0129] Fig.26J Shows Fig.26I A side view of a device for forming an anastomosis;

[0130] Figure 26K An embodiment of a device for forming an anastomosis is shown in a post-deployment coil configuration and includes a flange attached to each end of the coil;

[0131] Figure 26L Another embodiment of a device for forming an anastomosis is shown in a post-deployment coil configuration and includes a flange attached to each end of the coil;

[0132] Figure 26M Shows Figure 26L Additional views of a device for forming an anastomosis;

[0133] Fig.26N Shows Figure 26L A side view of a device for forming an anastomosis;

[0134] Fig.26O A mold is shown for forming a Figure 26L anastomotic device with a flange;

[0135] Fig. 27 An SMA coil device for forming an anastomosis (with a delivery catheter) is shown in a pre-deployment configuration according to an embodiment of the present specification;

[0136] Fig.28 An SMA coil device for forming an anastomosis in a pre-deployment configuration according to another embodiment of the present specification (with a delivery catheter) is shown;

[0137] Fig.29A A cautery tip for deployment with an anastomotic coil device according to various embodiments of the present specification is shown;

[0138] Fig.29B An anastomotic coil device provided with a cautery head in a pre-deployment configuration according to an embodiment of the present specification is shown;

[0139] Fig. 30A A side cross-sectional view of an anastomotic coil device with a distal cautery head in a pre-deployment configuration according to an embodiment of the present specification is shown;

[0140] Fig. 30B Shows Fig. 30A an enlarged view of the portion marked 3030 in FIG.

[0141] Fig. 30C Shows Fig. 30A an enlarged view of the portion marked 3040 in FIG.

[0142] Fig.30D Shows that there is Fig. 30A Another view of the cautery head and the anastomotic coil device capable of cauterization;

[0143] Fig.30E Shows Fig. 30A An enlarged view of the coupling mechanism of the pusher catheter and the proximal stop of the anastomotic coil device is shown;

[0144] 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;

[0145] Figure 30G Shows Fig.30F A front view of the cautery head is shown;

[0146] Fig. 30H Shows Fig.30F A side cross-sectional view of the cautery tip and cautery electrode shown;

[0147] Fig. 30I Shows Fig.30F The cautery electrode shown;

[0148] Fig.31A A cross-sectional view of a three-lumen catheter for delivering an anastomotic coil device according to an embodiment of the present specification is shown;

[0149] Fig.31B A side cross-sectional view of an anastomotic coil device in a pre-deployment configuration and a guidewire enclosed in a catheter for delivering the anastomotic coil device according to an embodiment of the present specification is shown;

[0150] Fig.31C Shown along Fig.31B A cross-sectional view of the CC axis is shown;

[0151] Fig.31D Shown along Fig.31B A cross-sectional view of the BB axis is shown;

[0152] Fig.31E Shown is the Fig.31B Another view of the catheter for delivery and guidewire of the anastomotic coil device is shown;

[0153] Fig.32A A cross-sectional view of an anastomotic coil device in a pre-deployment configuration disposed in a delivery catheter according to another embodiment of the present specification is shown;

[0154] Fig.32B Shown along Fig.32A A cross-sectional view of the BB axis is shown;

[0155] Fig.32C Shown along Fig.32A A cross-sectional view of the CC axis is shown;

[0156] Fig.32D Shown along Fig.32A A cross-sectional view of the DD axis is shown;

[0157] Fig.32E Shows Fig.32A An enlarged view of the conductor head is shown;

[0158] Fig.32F Shown in a post-deployment configuration after delivery into the body Fig.32A The anastomotic coil device shown;

[0159] Figure 32G Shows Fig.32F A cross-sectional view of the anastomotic coil device is shown;

[0160] Fig.32H Shown as Fig.32B O-rings for spacers;

[0161] Fig.33A A dual-handle delivery device according to an embodiment of the present specification is shown, which is used to deliver a stapling coil device provided with a cautery head;

[0162] Fig.33B Shows Fig.33A an enlarged view of the second handle shown;

[0163] Fig.34A A cross-sectional view of a dual-handle delivery device according to an embodiment of the present specification is shown, which is used to deliver a stapling coil device provided with a cautery head;

[0164] Fig.34B Shows Fig.34A An enlarged view of the head portion is shown;

[0165] Fig.34C Shows Fig.34B a cross-sectional view of the end portion shown;

[0166] Fig.34D Shows Fig.34A An enlarged view of the guidewire portion is shown;

[0167] Fig.34E Shows Fig.34D A cross-sectional view of the guidewire portion shown;

[0168] Fig.34F Shows Fig.34A An enlarged view of the handle portion is shown;

[0169] Fig.35is a flowchart showing the steps of forming anastomosis by using magnetic compressive force between a shape memory wire and an adjacent organ or structure according to an embodiment of the present specification;

[0170] Fig.36 is a flowchart showing the steps of forming an anastomosis by using a shape memory coil having a magnet between adjacent organs according to an embodiment of the present specification; and

[0171] Fig.37 is a flowchart showing the steps of forming anastomosis by using magnetic compressive force between a shape memory wire and an adjacent organ or structure according to an embodiment of the present specification;

[0172] 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 an embodiment of the present specification;

[0173] Fig.39A An exemplary magnet of a device for forming an anastomosis according to an embodiment of the present specification is shown;

[0174] Fig.39B An exemplary magnet of a device for forming anastomosis according to another embodiment of the present specification is shown;

[0175] Fig.39C is a diagram showing the relationship between the distance between coil loops and the extrusion pressure provided by a stapling device according to an embodiment of the present specification, the stapling device having a single coil loop on each side of a stapling to be formed;

[0176] Fig.39D is a diagram showing the relationship between the distance between coil loops and the extrusion pressure provided by a stapling device according to an embodiment of the present specification, the stapling device having two coil loops on each side of a stapling to be formed;

[0177] Fig.39E is a diagram showing the relationship between the distance between coil loops and the extrusion pressure provided by a stapling device according to an embodiment of the present specification, the stapling device having three coil loops on each side of a stapling to be formed;

[0178] Fig.39F is a graph showing the relationship between the distance between coil loops and the compression pressure provided by a stapling device having a 2.0 mm diameter magnet and a varying number of coil loops on each side of a stapling to be formed according to an embodiment of the present specification;

[0179] Figure 39Gis a graph showing the relationship between the distance between coil loops and the force provided by a stapling device having a 2.0 mm diameter magnet and a varying number of coil loops on each side of a stapling to be formed according to an embodiment of the present specification;

[0180] Fig.39H is a graph showing the relationship between the distance between coil loops and the compression pressure provided by a stapling device having a 2.5 mm diameter magnet and a varying number of coil loops on each side of a stapling to be formed according to an embodiment of the present specification;

[0181] Fig.39I is a graph showing the relationship between the distance between coil loops and the force provided by a stapling device having a 2.5 mm diameter magnet and a varying number of coil loops on each side of a stapling to be formed according to an embodiment of the present specification;

[0182] Fig.39J is a graph showing the relationship between the distance between coil loops and the compression pressure provided by a stapling device having a 3.0 mm diameter magnet and a varying number of coil loops on each side of a stapling to be formed according to an embodiment of the present specification;

[0183] Figure 39K is a graph showing the relationship between the distance between coil loops and the force provided by a stapling device having a 3.0 mm diameter magnet and a varying number of coil loops on each side of a stapling to be formed according to an embodiment of the present specification;

[0184] Fig.40A An exemplary device for forming an anastomosis in a pre-crimping configuration according to an embodiment of the present specification is shown;

[0185] Fig.40B Shown in a curled configuration Fig.40A a device for forming an anastomosis;

[0186] Fig.40C Shown in a curled configuration Fig.40A Another view of a device for forming an anastomosis;

[0187] Fig.40D A delivery device according to an embodiment of the present specification is shown, which is used to deliver a desired location in the body. Fig.40A , 40B and the anastomotic device shown in 40C;

[0188] Fig.40E The embodiment according to this specification is shown Fig.40D The delivery device shown is connected to Fig.40B and40C The crimping stapling device shown;

[0189] Fig.40F The embodiment according to this specification is shown Fig.40D Another view of the delivery device shown, which is connected to Fig.40B and 40C The crimping stapling device shown;

[0190] Figure 40G The embodiment according to this specification is shown Fig.40D Another view of the delivery device shown, which is connected to Fig.40B and 40C The crimping stapling device shown; and

[0191] Figure 40H is a flow chart listing the steps involved in a method of deploying an anastomotic device using a delivery device according to one embodiment of the present specification. DETAILED DESCRIPTION

[0192] 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 through tissue layers in the human body to form an opening or anastomosis. In one embodiment, a straight piece of SMA wire or longitudinally stretched coil, or any other generally planar structure is delivered at the location where the anastomosis is required in the body. In one embodiment, the SMA wire is 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 narrow long shape at room temperature and a compressed coil shape at human body temperature, preferably ranging from 97.7 degrees Fahrenheit (F) to 99.5℉. The coil can take a compressed shape at any temperature greater than 96℉.

[0193] The compression coil defines the desired shape and size of the desired anastomosis. The compression coil generates a compressive force on the tissue stuck between the coil loops. The coil winding action also causes the wire to form local ischemia, compressive necrosis, and cut through the desired tissue layer, forming anastomosis between two adjacent body tissues. In one embodiment, a plurality of magnets are arranged on each concentric ring of the wound wire. The magnets arranged on the adjacent rings attract each other, thereby enhancing the cutting action of the coil. In some embodiments, the compressive force is provided by the combination of the wound wire and the attraction between the magnets. In some embodiments, the shape of the anastomosis finally formed is mainly determined by the coil shape rather than by the force between the magnets. In various embodiments, the number of magnets used and the magnet length are determined by the shape, size or the time required to form anastomosis. In various embodiments, the time range required to form anastomosis is one day to fourteen days. In various embodiments, anastomosis is formed between two sections of SMA wire, between two or more magnets, or between an SMA wire segment and one or more magnets.

[0194] In various embodiments, the anastomotic device includes a wire having a plurality of magnets disposed on the wire. 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 using a delivery device, passing through a first wall of the first organ and through a second wall of a second organ, and entering a second lumen of the second organ, all while remaining at least partially as a delivery configuration on the delivery device. The anastomotic device is subsequently deployed so that a distal portion is disposed in the second lumen and a proximal portion of the device is disposed in the first lumen. Once deployed, 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 described in some embodiments of the specification is required to form a desired anastomosis, rather than requiring two separate mating devices as in the prior art, wherein a first device is deployed in a first lumen of a first organ and a second device is deployed in a second lumen of a second organ.

[0195] In various embodiments, the anastomotic device of the present disclosure is formed into a coil shape in a deployed configuration, having at least one coil with a proximal end and a distal end, wherein the proximal end and the distal end are at different levels.

[0196] In various embodiments, the deployed coil shape of the anastomotic device is formed solely by the action of the shape memory wire and / or magnetic force of the magnetic member without using any additional guiding elements, manipulators, radial members, hinges, or opening members.

[0197] It should be understood that the embodiments disclosed herein have some advantages over the prior art. First, the wire in the non-deployed state is transformed into a coil structure, and in the deployed state, an automatic extrusion action is achieved without the need for manual positioning of separate magnetic elements (which are not bolted to each other or positioned relative to each other in a fixed pre-deployment or post-deployment structure). More specifically, the alignment of the magnetic elements is achieved by their fixed position on the wire, and this natural transformation of the wire from a straight slender member to a coil shape can achieve the necessary automatic alignment of the magnetic elements and tissue extrusion. The reason why this can be achieved is that the embodiments disclosed herein provide magnetic elements that are bolted or physically connected to each other so that the magnetic elements have fixed predetermined positions relative to each other in pre-deployment and post-deployment structures. The connection is preferably achieved by wire, but sutures, tubes or other components can also be used to form a fixed relationship.

[0198] Therefore, the magnets used in the device have a fixed relationship with each other before and after deployment. The relative three-dimensional position of the first magnet is known and fixed relative to the three-dimensional position of the second magnet in an undeployed configuration (along the length of the straight wire) and a deployed configuration (coil shape). This fixed relationship realizes automatic alignment because the user does not need to manually place the magnets relative to each other to a specific position before deployment so that they are correctly connected in a deployed configuration. In other words, when the device is in a deployed configuration, the first magnet in the first coil is in a predetermined fixed position relative to the second magnet in the second coil, wherein the coil is separated by the tissue undergoing anastomosis. It should be noted that the predetermined fixed position can be one of several, but each position is predetermined and fixed. When the same device is in an undeployed (straight wire, non-coil) configuration, the same first magnet (now 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). These two relative positions are fixed and defined in the deployed and undeployed configurations, regardless of human intervention. Therefore, the first magnet and the second magnet automatically change from the first undeployed relatively fixed position to the second undeployed relatively fixed position, and at the same time, human deployment of the device will affect the transition from the undeployed state to the deployed state. Human intervention does not affect the predetermined fixed position of the first magnet relative to the second magnet in the undeployed state, and the predetermined fixed position of the first magnet relative to the second magnet in the deployed state.

[0199] In contrast, the prior art teaches separate magnetic assemblies (because they are not physically connected to each other in a fixed configuration in at least one or both of the pre-deployed or post-deployed shapes) that must be manually aligned relative to each other in order to achieve the correct compression force. This means that there is no predetermined fixed position of the first magnet assembly relative to the second magnet assembly in the undeployed state, because the position is different each time and depends on how the assembly is used. This also means that there is no predetermined fixed position of the first magnet relative to the second magnet in the deployed state.

[0200] Operationally, this self-aligning feature improves the safety of the device. Parts of the body experience tissue movement, such as peristalsis in the gastrointestinal (GI) tract, which will drive away or separate the two relative magnets that squeeze the tissue. Because the devices of the prior art include two independently moving magnetic structures, they always have a high risk of detaching and reattaching in different configurations or positions, thereby forming anastomoses in the wrong tissue, such as the wrong part of the patient's GI 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 detached, then the detachment will only be temporary and the two magnetic elements will automatically reattach on the target tissue area without human intervention. First, the two magnetic elements are in a fixed relationship, as described above. Second, they are in a fixed position relative to the target tissue because they have been inserted in place by passing through the target tissue. Thus, if they are temporarily separated, the magnets will not be able to travel (because the lower layer of silk has passed through the target tissue), and once the destructive movement is alleviated, they will curl back to their deployed structure. As a result, two magnetic elements on opposing coils that were separated by target tissue automatically reattach to each other after being temporarily separated by movement of the anatomy (at least 70% of the time, most likely at least 90%, 95%, and 99% of the time).

[0201] The coupling structure also allows for an easier deployment process. Rather than having to deploy two separate components on opposite sides of the tissue undergoing anastomosis, the physician deploys a single device that is used to achieve initial penetration of the tissue undergoing anastomosis and then automatically crimps, providing the necessary compressive force.

[0202] Second, the embodiments disclosed herein preferably use a solid 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 guide wire mechanism that incorporates the electrocautery puncture function into the anastomotic device itself; 2) avoiding the use of a tube, or a structure having any hollow lumen therein, which is complex to manufacture, difficult to deploy reliably, and results in the device being either too thick or having a magnet profile that is too small, thereby reducing the amount of available squeezing force; and 3) allowing the physician to place the device in locations that more acetic devices or catheters cannot reach, such as for pseudocysts. Although a solid wire is a preferred embodiment, all of the presently disclosed embodiments can be used with a hollow tube, such as a hollow nitinol wire, through which a guide wire can be passed and used to position the device.

[0203] Second, the embodiments disclosed herein propose a wire with multiple magnetic elements, which are preferably not firmly attached to the wire, but are tightly positioned above 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 fixed to the wire separately using flux, clamping parts, tabs, glue, welding, or friction assembly. On the contrary, the magnetic elements can be manufactured with inner cavities respectively, allowing larger tolerances, bundled on the wire via their inner cavities, and separated from adjacent magnetic elements using non-ferromagnetic spacers, avoiding any additional fixing steps for attaching the magnetic elements to the wire. This allows each magnetic element to have a fixed position relative to other magnetic elements on the same wire, without actually attaching each magnetic element to the wire. Furthermore, the fixing of the magnetic element with non-ferromagnetic spacers between each magnetic element (thereby forming an alternating sequence of magnetic elements and non-ferromagnetic spacers) prevents the undesirable aggregation or migration of magnets. Although the prior art discloses the use of jackets or protrusions from magnetic elements, such structures do not prevent the problem of magnetic aggregation or common migration outside of the preferred configuration or alignment. In fact, it is preferred for the magnetic elements to have smooth surfaces (no raised portions) to allow for greater alignment flexibility and without having to align non-raised portions with raised portions. However, it should be understood that in less preferred embodiments, each magnetic element can be attached to the wire and separated from adjacent magnetic elements by a spacer (not a solid non-ferromagnetic spacer made of, for example, plastic or other medically acceptable material).

[0204] Fourth, the disclosed coil structure allows for the application of multiple magnetic layers, thereby increasing the compressive force on the tissue surface without increasing the complexity of the medical procedure. If the prior art device is used, multiple individual and physically separate magnetic components on both sides of the tissue surface must be manually matched 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, and the multiple magnetic layers are automatically aligned with each other and are in fixed relative positions in the pre-deployment configuration and the post-deployment configuration.

[0205] The term "and / or" means one or all of the listed elements or any two or more of the listed elements.

[0206] In the description and claims of this application, the words "include," "comprises," and "have," each and various forms thereof, are not intended to limit the components to the list associated with the word.

[0207] Unless otherwise specified, "a," "an," "the," "one or more," and "at least one" are used interchangeably and mean one or more than one.

[0208] The term "pre-deployment" or "delivery" configuration refers to a configuration in which the solid wire upon which the magnetic element or member is placed is substantially straight or rectilinear.

[0209] The term "post-deployment" or "deployed" configuration refers to a configuration in which the solid wire upon which the magnetic element or member is placed is substantially coiled or assumes a helical shape.

[0210] For any method disclosed herein comprising discrete steps, these steps may be performed in any practicable order, and any combination of two or more steps may be performed simultaneously where appropriate.

[0211] As described herein, the numerical range defined by the endpoints includes all integers or fractional values ​​that fall within the range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). Unless otherwise stated, all numerical values ​​used in this specification and claims to represent components, molecular weights, etc. should be understood to be modified by the term "about" in all cases. Thus, unless otherwise described to the contrary, the numerical parameters described in this specification and claims are approximate values, which can be changed according to the desired performance to be achieved by the present invention. At least, and not to limit the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be understood in view of the number of important data described and by rounding.

[0212] Although the numerical ranges and parameters describing the broad scope of the invention are approximate, the numerical values ​​described in the specific examples should be understood as precisely as possible. However, all numerical values ​​are inherently contained within the ranges formed by the standard deviation in their corresponding test measurements. In other words, it should be understood that the dimensions provided herein are of critical importance because they allow the device to be small enough to be delivered into the required physical space in the body while still having sufficient compressive force to form anastomosis.

[0213] This specification relates to multiple embodiments. The following content is provided to enable those skilled in the art to implement the present invention. The language used in this specification should not be understood as a general negation of any specific embodiment or to limit the claims beyond the terms used herein. The general principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of the present invention. In addition, the terms and wording used are for the purpose of describing exemplary embodiments and should not be considered restrictive. Thus, the present invention should be consistent with the widest range of many replacement examples, modifications, and equivalent examples consistent with the principles and features. For the purpose of clarity, the details of the technical materials known in the technical field related to the present invention do not need to be described in detail so as not to unnecessarily affect the present invention.

[0214] It should be noted that any feature or component described in connection with a specific embodiment may be used and implemented by any other embodiment, unless explicitly described otherwise.

[0215] Figure 1 A straight SMA wire 102 is shown curled in a human body according to an embodiment of the present specification. The wire 102 is made of an SMA material such as Nitinol. A shape memory alloy (which is also alternatively 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 return to its pre-deformed shape when heated after being deformed. NiTi alloy changes from martensite to austenite when heated. 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 wire 102 has a diameter ranging from 0.1 to 6 mm, has a maximum strain of less than 10% in an uncurled position, and has a maximum cross-sectional dimension ranging from 5 mm to 60 mm in a curled position. In one embodiment, for a strain of 5%, and for a wire diameter of less than 0.75mm, 0.75mm to 1mm, and greater than 1mm, the diameter of the coiled wire is less than 15mm, 15mm to 20mm, and greater than 20mm, respectively. In one embodiment, for a strain of 10%, and for a wire diameter of 1mm, 1.25mm, 1.5mm, 1.7mm, 2mm, and 2.5mm, the diameter of the coiled wire is 10mm, 12.5mm, 15mm, 17mm, 20mm, and 25mm, respectively. In one embodiment, for a strain of 6%, and for a wire diameter of 0.6mm, 0.75mm, 0.9mm, 1.02mm, 1.2mm, and 1.5mm, the diameter of the coiled wire is 10mm, 12.5mm, 15mm, 17mm, 20mm, and 25mm, respectively. Further, in various embodiments, the wire 102 is coiled at least twice when delivered to the body.

[0216] A s and A f The temperature at which the transformation from martensite to austenite begins and ends. When inserted into the human body and placed in the anastomotic position, the wire 102 changes shape and curls (as shown by 104 or 106) in response to the higher human body temperature relative to room temperature. In various embodiments, the diameter of the wire 102 ranges from 0.1 mm to 10 mm and the length of the wire 102 ranges from 1 cm to 250 cm. In some embodiments, the loop 108 is provided at one or more ends of the wire for contact with the reference Fig.23A and B as described in the delivery catheter. In various embodiments, the wire A f The temperature is less than or equal to 40°C, and the A sThe temperature is less than or equal to 37° C. In various embodiments, the strain on the Nitinol wire in its 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 ​​approximately πr 2 In some embodiments, the A of the silk thread f The temperature (transformation temperature) is greater than or equal to 37°C, and a mechanism 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 mechanism 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.

[0217] Figure 2A plurality of magnets 202a, 202b, 202c, 202d, 202e, 202f are shown through loops 204, 206 of SMA wire according to an embodiment of the present specification. The loops 204 and 206 of the coil 200 thread through the magnets 202a, 202b, 202c, 202d, 202e, 202f. In one embodiment, the coil 200 is a nitinol wire that curls in response to temperature changes. There is a repulsive force between adjacent magnets 202a, 202b, and 202c threaded on the same loop 204, thereby maintaining a desired distance between the magnets. Similarly, there is a repulsive force between adjacent magnets 202d, 202e, and 202f threaded on the same loop 206, thereby maintaining a desired distance between these magnets. There is an attractive force between the magnets threaded on the loop 204 and the magnets on the coil 206. Thus, there is attraction between magnets 202a and 202d, between magnets 202b and 202e, and between magnets 202c and 202f. The attraction between the magnets on adjacent loops forms a squeeze force 207 between the loops of the coil, pulling the loops together to excise tissue between the loops and allowing the formation of anastomosis. In various embodiments, the squeeze force ranges from 0.1 to 0.5N, and the range of the associated pressure applied to the tissue layer stuck between the loops is 0.15psi-145psi (0.001 and 1MPa). In one embodiment, at least two magnets are connected to two adjacent loops of the coil 200 and the wire is curled into at least two loops. In one embodiment, the magnet is a rare earth magnet covered by a biocompatible material (e.g., gold, nickel, Teflon, Parylene, copper, zinc, silicone, epoxy, or titanium. In one embodiment, the coil 200 includes an RFID tag 210 to assist in positioning the coil 200 after deployment and during anastomosis formation. Using an RFID scanner, the position of the coil can be identified by communicating with the embedded RFID tag to determine the precise location of the coil in the patient's body without the need for radiation for visualization. In some embodiments, the magnet is rated N35 or greater.

[0218] In one embodiment, the Nitinol coil applies an amount of pressure on the tissue that is less than or equal to 50 mmHg (0.97 psi), and the magnet applies an amount of pressure on the tissue that is greater than 50 mmHg (0.97 psi). In another embodiment, the Nitinol coil applies an amount of pressure on the tissue that is less than or equal to 80 mmHg (1.57 psi), and the magnet applies an amount of pressure on the tissue that is greater than 80 mmHg (1.57 psi). In yet another embodiment, the Nitinol coil applies an amount of pressure on the tissue that is less than or equal to 120 mmHg (2.32 psi), and the magnet applies an amount of pressure on the tissue that is greater than 120 mmHg (2.32 psi). In yet another embodiment, the Nitinol coil applies an amount of pressure on the tissue that is less than or equal to 150 mmHg (2.90 psi), and the magnet applies an amount of pressure on the tissue that is greater than 150 mmHg (2.90 psi). In another embodiment, the nitinol coil applies an amount of pressure less than or equal to 200 mmHg (3.86) on the tissue, and the magnet applies an amount of pressure greater than 200 mmHg (3.86) on the tissue. In one embodiment, the coil pressure at each coil-tissue interface is sufficient to block capillary flow in the tissue by more than 50%. In one embodiment, the coil forms greater than or equal to 20 mmHg (0.39 psi) over more than one quarter of the coil circumference, and the pressure is relatively evenly distributed in both semicircles of each coil loop. In one embodiment, the pressure is greater than or equal to 20 mm Hg (0.39 psi) at two or more points on opposite sides of each coil loop.

[0219] In one of the embodiments, 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 promotes anastomosis formation. In some embodiments, the anastomosis formation process is accelerated by heating the coil by passing an electric current through the coil prior to deployment, thereby damaging / coagulating or ablating the intervening tissue.

[0220] Figure 3AAccording to an embodiment of the present specification, a gallbladder 302 with cholecystitis is shown, and by puncturing a gallstone 304 using a delivery catheter or needle, an endoscope is used to place an SMA anastomotic device to form an anastomosis. The gallbladder 302 with gallstones 304 is punctured by a delivery catheter or needle 306, which is inserted into the duodenum 310 of the patient through an endoscope 308. Using the device of the present specification, the catheter or needle 306 punctures the wall of the duodenum 310 and the gallbladder 302 so as to connect the gallbladder 302 to the duodenum 310 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 visualization. In another embodiment, the endoscope 308 is a duodenoscope and the puncture is performed by fluorescence visualization.

[0221] Figure 3B An SMA coil 312 is shown, which is deployed and in accordance with an embodiment of the present specification. Figure 3A An anastomosis is shown between the gallbladder 302 and the duodenum 310. An SMA coil 312 (which in one embodiment comprises a nitinol wire) is delivered through a hole punctured in the wall of the gallbladder 302 via an endoscope 308 through a catheter or needle. In response to exposure to body heat, the nitinol wire changes shape and curls, as shown in FIG. Figure 3B The coil 312 shown holds tissue of the gallbladder 302 wall and the duodenum 310 wall between the turns, thereby forming an anastomosis between the gallbladder 302 and the duodenum 310. The curling of the wire 312 causes a compressive force to act on the tissue caught between the coils, thereby cutting through the tissue to form the anastomosis. In one embodiment, a magnet may 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 within a time period that allows for angiogenesis of the anastomosis, resulting in a strong and stable anastomosis without significant leakage.

[0222] Figure 3C An SMA coil 332 is shown in accordance with another embodiment of the present specification, strung with a magnet 334 to form an anastomosis between a gallbladder 322 and a duodenum 320. The SMA coil 332 (which in one embodiment comprises Nitinol) is strung with magnets 334 placed in different / adjacent coil loops. The magnets 334 placed in different coil loops attract each other, thereby further increasing the compressive force in the coil 332 and accelerating or improving the resection of the gallbladder and duodenal wall to form the anastomotic opening. Figure 3D is a close-up view of an SMA coil 332 according to an embodiment of the present specification, the SMA coil and Figure 3CThe coil 332 is strung together with the magnets 334a and 334b ​​in the loop 336 and the magnets 334c and 334d in the loop 338. The magnetic poles of the magnets 334a and 334b ​​are arranged so that the magnets repel each other, thereby maintaining a constant predetermined distance between each other on the loop 336. Similarly, the magnetic poles of the magnets 334c and 334d are arranged so that the magnets repel each other, thereby maintaining a constant predetermined distance between each other on the loop 338. The magnetic poles of the magnets 334a and 334c are arranged so that the magnets attract each other, thereby pulling the loops 336 and 338 of the coil 332 closer to each other and increasing the squeezing force applied by the coil 332 on the tissue layer stuck between the loops of the coil 332. Similarly, the squeezing force is caused by the attraction between the magnets 334b ​​and 334d. As the magnets cut through the tissue and come into close proximity, the compressive force increases gradually over time, slowly accelerating the cutting action and forming the anastomosis once the two walls have had time to fuse together. This approach reduces the risk of leakage in situations where the anastomosis is performed too quickly to allow the two adjacent walls enough time to fuse together.

[0223] Figure 4A 4 shows a first stage of the anastomosis process according to an embodiment of the present specification. As shown, organ walls 402 and 404 are captured between adjacent loops 407, 409 of coil 406. In one embodiment, 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 predetermined shape and size so that adjacent organ walls are captured 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 toward each other and increasing the squeezing force applied by coil 406 on organ walls 402 and 404. While the magnets apply the gradually increasing squeezing force (which accelerates when the anastomosis is formed), the SMA wire applies a relatively stable force over time, thereby achieving initial fusion of the walls and cutting through the walls once the two walls have fused. In some embodiments, the squeezing surface is provided by two opposing magnets or a wire and a magnet.

[0224] Figure 4B The embodiment according to this 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 drawn together by magnetic force 413 that draws magnets 408, 410 together, thereby squeezing organ walls 402 and 404 between loops 407 and 409, causing ischemia followed by angiogenesis that allows fusion of the two organ walls. Figure 4C The embodiment according to this specification is shown Figure 4A and 4B The third stage of the anastomosis process is shown. As shown, the squeezing force of the coil 406, which is further enhanced by the magnetic force 413 between the magnets 408, 410, causes complete ischemia, apoptosis and ischemic necrosis of the tissue stuck in the center of the coil, and causes the loops 407, 409 of the coil 406 and / or the magnet 408 to cut through the organ walls 402, 404. Figure 4D The example according to the embodiment of this specification is shown as Figure 4A , 4B 4C shows the formation of the anastomosis in the fourth and final stage of the anastomosis process. As shown, the opening / anastomosis 415 is formed due to the organ wall 402, 404 being cut by the coil, which then falls off and passes through naturally without the need for endoscopic inspection. In one embodiment, the coil is designed to facilitate passing after cutting through the wall in the antegrade direction or retrograde direction. In another embodiment, the coil is configured to hold the anastomosis for subsequent removal using an endoscope.

[0225] Figure 5Table 500 is shown according to the embodiment of the present specification, showing the exemplary size of the anastomotic device for forming anastomosis. Column 502 shows the exemplary diameter (mm) of the coil, and columns 504, 506, 508, 510 and 512 respectively show the corresponding exemplary length (cm) of the silk thread that can be curled into 1, 2, 4, 8 and 16 loops. The expected diameter of the anastomosis portion is 0.5cm to 5cm and the expected length of the coil silk thread is 3cm to 250cm. The preferred diameter of the anastomosis portion depends on the specific organ, and is 1-2cm for the gallbladder, 0.5-1cm for the bile duct, 1-2cm for cystic gastrectomy or cystic jejunostomy drainage, and 2-5cm for the gastrojejunostomy of intestinal-intestinal anastomosis. However, these are representative numbers, and in practice, the diameter of the coil is determined based on the diameter of the organ and the indication to be 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 biliary 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 depends on the total magnetic force required to form the anastomosis, which in turn depends on the total thickness of the organ wall to be anastomosed. In some embodiments, the SMA wire is delivered to the body by using an endoscope, so the length of the wire required is 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 each with a diameter of 2 cm or 8 coil loops each with a diameter of 4 cm are obtained. In an embodiment where the length of the SMA wire is 250 cm, 16 coil loops each having a diameter of 5 cm are obtained. Further, in various embodiments, a device having two coil loops (each including 8 magnets) and another device having 8 coil loops (each including 2 magnets) each cause the same extrusion force on the tissue stuck between the corresponding coil loops. The size of the anastomosis required in the tissue determines the diameter of each coil loop, which in turn determines the number of magnets (and their length) used in association with the SMA wire that causes the anastomosis. The required extrusion force is an extrusion 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 completely along each coil loop. In one embodiment, the pressure is applied at least along four points on each coil loop. In other embodiments, depending on the size of the loop, the pressure is applied at two or eight points along the circumference of each loop.

[0226] In various embodiments, the diameter of the SMA wire used for the anastomosis ranges from 0.1 mm to 6 mm, and the coil pitch is less than 10 mm. In various embodiments, the maximum cross-sectional diameter of the SMA coil ranges from 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.

[0227] The maximum strain of 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, and the wire with a diameter less than or equal to 0.75mm is preferably formed into a coil with a diameter less than or equal to 15mm, and the wire with a diameter of 0.75-1.0mm is preferably formed into a coil with a diameter of 15-25mm, and the wire with a diameter greater than or equal to 1mm is preferably formed into a coil with a diameter greater than or equal to 25mm. In various embodiments, at the coil-tissue boundary interface, the magnet and SMA wire cause a pressure of at least 0.15psi, more preferably at least 1.0psi, and most preferably at least 2.50psi, to cut off the blood supply in the tissue. In certain embodiments, a pressure of up to 4.0psi is applied. In various embodiments, at the coil-tissue boundary interface, the magnet and SMA wire make the pressure equal to or less than 145psi.

[0228] In various embodiments, the magnets coupled to the SMA coils are rare earth magnets or permanent magnets, each having a maximum cross-sectional length of 0.2 mm to 7 mm and a pulling force of 0.1 lb to 4 lb (0.04-17.8 N). In some embodiments, neodymium magnets having a maximum energy product 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 less than 80°C and the desired material grade for the neodymium magnet is N30-N60. Ideally, N35-N110, N55 neodymium magnets or comparable rare earth magnets are used.

[0229] In various embodiments, the shape of the anastomosis (e.g., Figures 4A-4D The shape of the SMA wire (as shown) is determined by the shape of the coiled SMA wire. For example, a square coil forms a square anastomosis. Figure 6A square SMA coil 600 is shown coupled to magnets 602 for forming an anastomosis in accordance with an embodiment of the present specification. The square Nitinol coil 600 is coupled to eight magnets 602, four on each of two separate loops 604 and 606. There is a repulsive force between magnets coupled to the same loop, thereby keeping the magnets separated by a predetermined distance. There is an attractive force between corresponding magnets placed on adjacent loops 604 and 606, thereby increasing the squeezing force of the coil 600 and pulling the loops 604 and 606 closer to each other for forming a square incision in the tissue.

[0230] Fig. 7A A hexagonal SMA coil 700 is shown coupled to a magnet 702 for forming an anastomosis in accordance with an embodiment of the present specification. The hexagonal coiled SMA wire 700 coupled to the magnet 702 forms a hexagonal anastomosis between two organs by cutting through the organ walls in a hexagonal shape. Figure 7B The embodiment according to this specification is shown 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 about 0.4 mm, the length 706 of one side of the hexagonal loop is about 6 mm, and the circumference 708 of the wire forming the coil is about 0.4 mm. The pitch of the coil in the deployed (austenitic) state of various embodiments can vary from the diameter of the SMA wire to 5 times the diameter of the wire used in the coil and is always less than the diameter of the coil.

[0231] Figure 7C A decagonal SMA coil 712 is shown coupled to a magnet 714 for forming an anastomosis according to an embodiment of the present specification. Figure 7C , the magnet 714 is coupled to the coil 712 such that the magnet 714 is primarily positioned on an outer surface of the coil 712 . Fig.7D 7 shows a decagonal SMA coil 722 coupled to a magnet 724 for forming an anastomosis according to another embodiment of the present specification. Fig.7D , the magnet 724 is coupled to the coil 722 such that the magnet 724 is primarily positioned on an inner surface of the coil 722 . Figure 7C The coil in is preferred in indications where it is desired that the anastomotic device pass spontaneously after the anastomosis is formed, while Fig.7D The coil is preferred in indications where it is desired that the anastomotic device does not pass spontaneously after the anastomosis is formed.

[0232] Fig. 7EExemplary dimensions of a decagonal SMA coil 732 coupled with magnets 734 for forming a stapling are shown in accordance with an embodiment of the present specification. The magnets 734 are coupled to the coil 732 such that the magnets 734 are primarily positioned on the outer surface of the coil 732. In one embodiment, the area of ​​the coil 732 with the magnets 734 (which will produce a stapling with the same area) 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. In one embodiment, the circumference of the coil 732 with the magnets 734 (which will produce a stapling with the same circumference) is equal to 10×a, where a is the length of each magnet 734.

[0233] Figure 7F A dodecagonal SMA coil 742 is shown coupled to a magnet 744 for forming an anastomosis according to an embodiment of the present specification. A spacer 746 is included on the coil 742 between each pair of magnets 744. In one embodiment, a spacer is included on the SMA coil to reduce the number of magnets required to obtain the desired extrusion force. In one embodiment, the spacer 746 comprises a non-ferromagnetic material or a biocompatible material. In various embodiments, the spacer 746 comprises a silicone or nitinol tube or an O-ring or a round ball. In one embodiment, the internal angle 747 formed between adjacent magnets 744 is equal to 150°. In one embodiment, an angle 749 formed at the center of a circle formed by the coil 742 and corresponding to each magnet 744 is equal to 30°. The non-ferromagnetic spacer prevents the magnets from sticking together when the coil is in its relatively straight martensitic pre-deployment shape and prevents it from assuming its curled austenitic post-deployment 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, allowing the coil to achieve its predetermined post-deployment shape. In one embodiment, the outer diameter of the spacer ring is 25% to 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.

[0234] Figure 7G-7K Various embodiments are shown in which the coil has a regular polygonal cross-section that is both equiangular and equilateral, where a=side length, r=inscribed circle radius (distance between apices), R=circumscribed circle radius, A=area, P=perimeter, x=inner angle, y=outer angle, and n=number of sides. The side length is represented by the formula a=2r tan(π / n)=2R sin(π / n); the inscribed circle radius r is represented by the formula r=(1 / 2)a cot(π / n)=R cos(π / n); the circumscribed circle radius R is represented by the formula R=(1 / 2)a csc(π / n)=r sec(π / n); the area A is represented by the formula A=(1 / 4)na 2 cot(π / n)=nr 2tan(π / n); the perimeter P is represented by the formula P=na; the interior angle x is represented by the formula x=((n-2)π / n)radians=(((n-2) / n)×180°) degrees, and the exterior angle y is represented by the formula y=(2π / n)radians=(360° / n) degrees. The shape and size of the polygon determine the shape and size of the anastomosis. 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, and Figure 7K A tetradecagonal SMA coil 760 is shown.

[0235] Figure 8 The process of forming an anastomosis by using an SMA coil with or without a magnet according to an embodiment of the present specification is shown. As shown, a first wall 802 of a first organ and a second wall 804 of a second organ are squeezed between loops of an SMA wire 806 that is curled into a circle. A circular portion 808 of tissue of both the first and second organs is trapped between the wires 806. Due to the pressure applied by the wires 806, the blood supply 809 to this portion 808 is slowly and gradually reduced, first causing ischemia, inflammation, angiogenesis and fusion of adjacent walls, and then the pressure increases ischemic damage and necrosis of the tissue 808, which eventually falls off, leaving a circular anastomosis 810 between the first and second organ walls. In this embodiment, the slow and gradual increase in pressure allows the angiogenesis process to occur at the anastomotic site to ensure a healthy anastomosis.

[0236] Fig. 9A The walls 902, 904 of two organs are shown squeezed between loops 906, 908 of an SMA coil 900, with the squeezing force provided by a combination of Nitinol wire and magnets, and the cutting surface formed by the two SMA wires 906 and 908, in accordance with an embodiment of the present specification. Fig. 9B The walls 902, 904 of two organs are shown being squeezed between the loops of an SMA coil 900, the squeezing force being enhanced by the use of magnets, according to an embodiment of the present specification. Fig. 9A and 9B, the wall 902 of the first organ and the wall 904 of the second organ are squeezed between the first loop 906 and the second loop 908 of the SMA coil 900, which in one embodiment is a nitinol coil. The pressure applied to the organ walls 902, 904 is enhanced by the attractive force 913 between the magnets 910 and 912 respectively coupled to the loops 914 and 916 of the SMA coil 900. In one embodiment, a first pressure greater than 0.19 psi (10 mmHg) is applied to the tissue trapped between the coil loops by the combination of the coil and the magnet, and the pressure is gradually increased to a pressure greater than or equal to 0.97 psi (50 mmHg), and can be further increased to a pressure of 145 psi (7499 mmHg), depending on the size of the magnet and the number of coils.

[0237] Fig.10 The walls 1002, 1004 of two organs are shown squeezed between a loop 1006 of an SMA coil 1000 and a magnet 1008 in accordance with an embodiment of the present specification. The wall 1002 of the first organ and the wall 1004 of the second organ are squeezed 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 an embodiment, the SMA coil 1000 is a Nitinol coil. The pressure exerted on the organ walls 1002, 1004 is enhanced by an attractive force 1013 between another magnet 1012 coupled to another loop 1014 of the SMA coil 1000 and the magnet 1008.

[0238] Importantly, the magnets do not interfere with the SMA coil shape change to the intended post-deployment austenitic shape by attracting and clumping together in the pre-deployment 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 an anastomosis in accordance with an embodiment of the present specification. The magnets 1104a-1104d are arranged around the loop 1102 of the SMA coil 1100 for forming an anastomosis. 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, the magnets are coupled to the coil in a manner such that the magnets are slidable on the coil (like beads on a string). In one embodiment, at least 50% of the adjacent magnets (e.g., magnets 1104a and 1104b) on each loop of the coil are arranged with the same poles facing each other (e.g., 'S' for south and 'N' for north on each magnet), creating a repulsive force between two adjacent magnets in the same loop of the coil. It is necessary to form a gap between the Nitinol wire and the magnet. Fig.10 and 13This configuration is desirable for use in the illustrated fit.In various embodiments, the magnets on a single loop of the coil are separated by a distance that is less than, equal to, or greater than the length of each of two adjacent magnets.

[0239] 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, the magnets 1204a-1204h are coupled to the coil loop 1202 in a manner such that the magnets can slide over the coil (like beads on a string). In one embodiment, at least 50% of the adjacent magnets (e.g., magnets 1204a and 1204b) on each loop of the coil are arranged with the same poles facing each other (e.g., 'S' represents south and 'N' represents north on each magnet), thereby forming 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 that they significantly interfere with the function of the Nitinol coil. It is also important that the repulsive forces between the magnets do not overwhelm and significantly interfere with the function of the Nitinol coil. In some embodiments, the axis defining 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 defining the direction of magnetic attraction between magnets on adjacent loops of the coil extends through the center of the coil.

[0240] Fig.13 The placement of magnets 1302, 1304, 1308, 1310 coupled to adjacent loops 1306, 1312 of SMA coils for forming a mating pattern is shown in accordance with an embodiment of the present specification. As shown, adjacent magnets 1302 and 1304 on coil 1306 are held a distance apart that is greater than the length of each magnet. Similarly, adjacent magnets 1308 and 1310 on adjacent coil 1312 are held a distance apart that is 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 opposite poles of magnets 1308 and 1302 are aligned. This creates pressure between the magnets on the adjacent wire loops, which in turn aids in the previously described method of positioning the magnets 1308 and 1310 against each other. Fig.10 The anastomosis process described.

[0241] Fig.14AAn exemplary SMA wire 1400 for forming an anastomosis is shown coupled with magnets 1408, 1408a, 1408b, 1408c, 1408d prior to deployment in the body in accordance with an embodiment of the present specification. Fig. 14B The embodiment of the present specification is in the middle stage of deployment. Fig.14A An exemplary SMA wire 1400 coupled to a magnet 1408 is shown. Fig. 14C An exemplary SMA wire 1400 for forming an anastomosis after deployment in the body according to an embodiment of the present specification is shown. Fig.14A The magnet 1408 shown is coupled. Fig.14A , before deployment, the SMA wire 1400 is straight and is divided into at least three sections 1402, 1404 and 1406. Sections 1402 and 1406 are coupled with 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 magnet and the last magnet of each section. As shown, no magnets are provided on section 1404. See FIG. Fig. 14B , the SMA wire 1400 curls when exposed to body heat. Fig. 14C , the SMA wire 1400 forms a tight coil that cuts through the tissue caught between the coil loops, and the cutting force is further enhanced due to the attraction between the magnets placed on the adjacent loop portions 1402 and 1406. This anastomosis mechanism is as follows Fig. 9A and 9B shown.

[0242] Fig.14DAn exemplary SMA wire 1420 for forming anastomosis is shown before being deployed in the body according to another embodiment of the present specification, which is coupled with magnets 1428, 1428a, 1428b, 1428c, 1428d. Before deployment, the SMA wire 1420 is straight and is divided into at least three parts 1422, 1424 and 1426. Parts 1422 and 1426 are coupled with a plurality of magnets 1428, 1428a, 1428b, 1428c, 1428d so that the positions of the first magnets 1428a, 1428c and the last magnets 1428b, 1428d of parts 1422 and 1424 are fixed and immovable, respectively. The remaining magnets 1428 of each part are movable / slidable in the space between the first magnet and the last magnet of each part. As shown, no magnets are provided on part 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 include magnets. In various embodiments, the length of the exposed wire portions 1420a, 1420b is greater than or equal to half the circumference of one of the coil loops. The length of the exposed segment in the middle of the device is also greater than or equal to Fig.14F Half the circumference of one of the loops of the coil shown. The advantage of the exposed portion at the end is that the SMA coil is better (more round) and more consistent (under the influence of the magnetic force) if the loop has already been formed (it forces the loop to be shaped afterwards). This is a result of the inherent strain in the wire.

[0243] Fig.14E The embodiment of the present specification is in the middle stage of deployment. Fig.14D An exemplary SMA wire 1420 coupled to a magnet 1428 is shown. Fig.14F An exemplary SMA wire 1420 for forming an anastomosis after deployment in the body according to an embodiment of the present specification is shown. Fig.14D The magnet 1428 shown is coupled. Fig.14E , the SMA wire 1420 begins to curl when exposed to body heat. Fig.14F , the SMA wire 1420 forms a tight coil that cuts through the tissue caught between the coil loops, and the cutting force is further enhanced due to the attraction between the magnets placed on the adjacent loop portions 1422 and 1426. This anastomosis mechanism is as follows Fig. 9A and 9B shown.

[0244] Fig.15AAn exemplary SMA wire 1500 for forming an anastomosis is shown coupled with magnets 1502, 1502a, 1502b prior to deployment in the body in accordance with another embodiment of the present description. Fig. 15B The embodiment of the present specification is in the middle stage of deployment. Fig.15A An exemplary SMA wire 1500 coupled to magnets 1502, 1502a, 1502b is shown. Fig. 15C An exemplary SMA wire 1500 for forming an anastomosis after deployment in the body according to an embodiment of the present specification is shown. Fig.15A The magnets 1502 shown are coupled. Fig.15A , before deployment, 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 magnet 1502a and the last magnet 1502b. See Fig. 15B , the SMA wire 1500 curls when exposed to body heat. Fig. 15C , the SMA wire 1500 forms a tight coil that cuts through the tissue caught 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 Fig.17A The two magnets shown provide two cutting surfaces.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 coils.

[0245] Fig.15DAn exemplary SMA wire 1520 for forming anastomosis before being deployed in the body according to yet another embodiment of the present specification is shown, which is coupled to magnets 1522, 1522a, 1522b. Before deployment, the SMA wire 1520 is straight and coupled to a plurality of magnets 1522, 1522a, 1522b so 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 are movable / slidable in the space between the first magnet 1522a and the last magnet 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 include magnets. In various embodiments, the length of the exposed wire portions 1520a, 1520b is greater than or equal to half the circumference of one of the coil loops. The length of the exposed segment in the middle of the device is also greater than or equal to Fig.15F Half the circumference of one of the loops of the coil shown. The advantage of the exposed portion at the end is that the SMA coil is better (more round) and more consistent (under the influence of the magnetic force) if the loop has already been formed (it forces the loop to be shaped afterwards). This is a result of the inherent strain in the wire.

[0246] Fig.15E The embodiment of the present specification is in the middle stage of deployment. Fig.15D An exemplary SMA wire 1520 coupled to magnets 1522, 1522a, 1522b is shown. Fig.15F An exemplary SMA wire 1520 for forming an anastomosis after deployment in the body according to an embodiment of the present specification is shown. Fig.15D The magnet 1522 shown is coupled. Fig.15E , the SMA wire 1520 curls when exposed to body heat. Fig.15F The SMA wire 1520 forms a tight coil that cuts through the tissue caught between the coil loops, and the cutting force is further enhanced due to the attraction between the magnets 1522 placed on the adjacent loops of the coil 1502. Fig. 9A and 9B In some embodiments, the Fig.17A The two magnets shown provide two cutting surfaces.In some embodiments, the movement of magnets 1522a and 1522b is limited by stops at the ends, thereby preventing the end magnets from sliding off the SMA coils.

[0247] Figure 15G1 is a diagram according to an embodiment of the present specification, which shows the pressure 1511 applied to body tissue by the loop of the coil as the distance 1517 between the magnets on the coil decreases. The first curve 1510 represents the pressure applied by the coil with N52 neodymium magnets. The second curve 1512 represents the pressure applied by the coil with N40 neodymium magnets. The pressure 1511 applied by the loop of the coil represented by the two curves 1510, 1512 increases as the distance 1517 between the magnets decreases, especially at a distance of less than 2mm. At a distance greater than or equal to 5mm, the anastomotic device causes capillary blood flow obstruction without blocking arterial or venous blood flow, causing low levels of inflammation and fibrosis and causing fusion between two adjacent organ walls. Once the distance 1517 becomes 1mm or less, the pressure applied by the two curves 1510, 1512 is greater than the arterial occlusion pressure 1515, as shown 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 coil is great enough to cause occlusion of all blood vessels in the body tissue caught between the loops, thereby causing ischemic damage to the tissue, necrosis, and resulting in the formation of an anastomosis whose dimensions are approximately the dimensions of the nitinol loops. This slow increase in pressure on the tissue allows for angiogenesis, fusion of adjacent tissue walls, and the formation of a healthy anastomosis without the anastomotic leak rates common with surgical anastomoses.

[0248] Fig.16A An exemplary circular SMA coil 1602 for forming an anastomosis is shown in accordance with an embodiment of the present specification. Coil 1602 includes a plurality of circular loops 1604. Fig. 16B An exemplary circular SMA coil 1606 with a cutting edge 1610 is shown for forming an anastomosis in accordance with an embodiment of the present specification. Coil 1606 includes a plurality of circular loops 1608. One of the loops 1608 is provided with a pointed / sharp cutting edge 1610 for cutting through tissue squeezed between the loops of the coil. Fig. 16C An exemplary square SMA coil 1612 for forming a fit is shown in accordance with an embodiment of the present specification. Coil 1612 includes a plurality of square loops 1614. The sharp edges of the square loops are provided for cutting a surface.

[0249] Fig.17A An exemplary device 1700 is shown that includes circular magnets 1702 coupled to SMA coils for forming anastomoses, in accordance with an embodiment of the present specification. Circular magnets 1702 are each coupled to a coil loop 1704 for forming anastomoses when deployed in the body. Fig. 17BAn exemplary device 1705 according to an embodiment of the present specification is shown, which includes circular magnets 1706 coupled to an SMA coil for anastomosis, wherein at least one magnet includes a cutting edge 1710. As shown, each of the circular magnets 1706 is coupled to a coil loop 1708 for forming anastomosis when deployed in the body. At least one of the magnets 1706 is provided with a pointed / sharp protrusion 1710 designed to interlock with the other magnets / coil loops and enhance cutting of tissue squeezed between the coil loops and the magnets.

[0250] Fig. 17C An exemplary device 1711 according to an embodiment of the present specification is shown, which includes a square magnet 1712 coupled to an SMA coil with a serrated edge for forming an anastomosis. The square magnet 1712 is arranged around a coil loop 1714 with a serrated edge to prevent rotational movement of the magnet 1712. In one embodiment, the magnet 1712 is as shown in FIG. Fig. 17C The arrangement shown in , causes the edges 1716 of the magnets to slide over each other as the SMA wire changes shape and curls, further enhanced by the attractive force between the magnetic surfaces, thereby creating a cutting action / force.

[0251] Fig.17D An exemplary device 1721 is shown that includes square magnets 1718 coupled to SMA coils for forming anastomoses, in accordance with an embodiment of the present specification. The square magnets 1718 are each coupled to a coil loop 1720 for forming anastomoses when deployed in the body. Fig.17E An exemplary device 1725 according to an 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 of the square magnets 1722 is coupled to a coil loop 1724 for forming an anastomosis when deployed in the body. At least one of the magnets 1722 is provided with a pointed / sharp protrusion 1726 designed to interlock with the other magnets / coil loops and enhance cutting of tissue squeezed between the coil loops and the magnets.

[0252] Fig.17F A cross-sectional view of an exemplary device 1729 according to an embodiment of the present specification is shown, which includes a circular magnet 1728 coupled to an SMA coil for forming an anastomosis, wherein the magnet 1728 includes a protruding edge 1732. The circular magnets 1728 are each coupled to a coil loop 1730 for forming an anastomosis when deployed in the body. The magnet 1728 is provided with a protruding edge 1732, which is designed to interlock with other magnets / coil loops and enhance the cutting of tissue squeezed between the coil loop and the magnet. Figure 17GA cross-sectional view of an exemplary device 1735 according to an embodiment of the present specification is shown, which includes a square magnet 1734 coupled to an SMA coil for forming an anastomosis, wherein the magnet includes a protruding edge 1738. Each of the square magnets 1734 is coupled to a coil loop 1736 for forming an anastomosis when deployed in the body. The magnets 1734 are provided with a protruding edge 1738, which is designed to interlock with other magnets / coil loops and enhance the cutting of tissue squeezed between the coil loop and the magnet.

[0253] Fig.18A and 18B A plurality of magnets 1802, 1803 are shown arranged around a loop 1804 of SMA wire 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 loop 1804 of the SMA wire coil in such a manner that the opposing poles of adjacent magnets face each other, thereby forming a repulsive force that holds the magnets 1802, 1803 fixed in a desired position on the loop 1804. Thus, the magnets 1802, 1803 are not clustered together on the loop 1804. In one embodiment, as shown in FIG. Fig.18A As shown, magnet 1802 is provided with a ring 1806 through which loop 1804 passes, for coupling magnet 1802 with loop 1804. In another embodiment, as shown in FIG. Fig.18B As shown, magnet 1802 is coupled to loop 1804, wherein magnet 1803 includes a hollow tube (not shown) for passing loop 1804. In other embodiments, the magnet is coupled to the loop in any suitable manner, wherein the magnet can slide freely along the loop.

[0254] Fig. 18C and 18D A plurality of magnets 1810, 1807 are shown arranged around a loop 1812 of SMA wire coils 1811, 1813 and separated by non-ferromagnetic spacers 1814 for forming an anastomosis in accordance with an embodiment of the present specification. Fig. 18CAs shown, the SMA coil loop 1812 passes through the ring 1808 of the magnet 1810. The magnets 1810 are arranged so that the opposite poles of the adjacent magnets face each other, thereby forming an attractive force. A spacer 1814 made of a non-ferromagnetic material is placed between the magnets 1810, as shown, which keeps the magnets 1810 fixed in the desired position on the loop 1812, thereby ensuring that the magnets 1810 will not gather together on the loop 1812 and will not interfere with the shape change from the martensite shape to the austenite shape. In various embodiments, 1814 includes silicone, Teflon, PTFE, or Nitinol tubes, O-rings or balls. In another embodiment, the spacer 1814 only includes air, wherein each spacer 1814 is formed by gluing or fixing each magnet 1810, 1807 to the 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 1 / 128 inch to 1 inch. In other embodiments, the predetermined distance between adjacent magnets on the same loop of the coil is 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, which is sufficient to ensure that the magnets do not 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, which is sufficient to ensure that the magnets do not physically contact each other until 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 greater 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 < 50% of the circumference of the coil. See. Fig.18D , the magnet 1807 of the coil 1813 includes a hollow tube through which the coil loop 1812 passes. Spacers 1814 made of non-ferromagnetic material are placed between the magnets 1807, as shown, thereby ensuring that the magnets 1807 do not gather together on the loop 1812.

[0255] Fig.18EAn arrangement of magnets 1820, 1820a, 1820b around a loop 1824 of an SMA coil 1821 is shown for forming anastomosis according to an embodiment of the present specification. Magnet 1820 is arranged by a ring 1822 around a loop 1824 of an SMA coil 1821. Magnet 1826 adjacent to loop 1828 is positioned near and between the poles of magnets 1820a and 1820b of loop 1824 by magnetic attraction. Magnet 1826 serves as a locking magnet, thereby locking each magnet 1820a and 1820b in their respective fixed positions on the coil loop 1824 forming a kind of lasso. This forms a fixed loop that can be used to draw the wall of an adjacent organ closer during deployment. The locking mechanism also prevents the loop from accidentally slipping off the organ during deployment.

[0256] Fig.18F Another arrangement of magnets 1830, 1830a, 1830 around a loop 1834 of an SMA coil 1835 is shown for forming an anastomosis according to an embodiment of the present specification. Magnet 1830 is arranged around the loop 1834 of an SMA coil 1835. Magnet 1836 adjacent to loop 1838 is positioned near and between the poles of magnets 1830a and 1830b of loop 1834 by magnetic attraction. Magnet 1836 acts as a locking magnet, thereby locking each magnet 1830a and 1830b in their respective fixed positions on the coil loop 1834. This forms a fixed loop that can be used to draw the walls of adjacent organs closer during deployment. The locking mechanism also prevents the loop from accidentally slipping off the organ during deployment, as described above. A spacer 1840 made of a non-ferromagnetic material is also placed between the magnets 1830, as shown, thereby ensuring that the magnets 1830 do not bunch together on the ring 1834. The spacer 1840 includes silicone, Teflon, PTFE or Nitinol tubes.

[0257] Fig.19A , 19B 19C show steps for forming an anastomosis between two organs in a human body according to an 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 near the pseudocyst wall is identified by endoscope 1906. Using endoscope 1906, a hollow needle or catheter 1910 having an inner lumen for carrying an SMA thread 1912 (which can be coupled to a magnet 1914) is delivered to the identified location. Needle or catheter 1910 is used to penetrate the organ wall and deliver SMA thread 1912 therein. During deployment, SMA thread 1912 passes through the inner lumen of needle or catheter 1910 until about 1 / 2 of the thread is deployed in pseudocyst 1902 along with magnet 1914. Adjacent loops of the thread in the pseudocyst can be attracted together, as in Fig.18E and 18F, and the loop can be used to pull the pseudocyst wall toward the stomach wall. The needle or catheter 1910 is then withdrawn into the stomach 1901 with the endoscope 1906, and the remaining 1 / 2 silk thread 1912 and magnet 1914 are deployed so that a portion of the silk thread is stored in each of the pseudocyst and the stomach. When exposed to body heat, the straight SMA silk thread 1912 curls and squeezes the adjacent organs (pseudocyst 1902 and stomach 1901) together, and the loop of the coil 1912 slowly cuts through the wall of the adjacent organs to form anastomosis, as described above. The squeezing force can be provided only by the coil or in association with the magnet. Once the coil 1912 has completely cut through the two walls to form a stable anastomosis 1920, the coil 1912 falls off spontaneously and naturally passes through the body, or it can be removed using an endoscope or any other minimally invasive technique.

[0258] Fig. 20A A non-ablative needle 2002 is shown for delivering an SMA coil 2006 in the body, in accordance with an embodiment of the present specification. The non-ablative hollow needle 2002 includes a lumen 2004 in which an SMA stapling coil 2006 is disposed for endoscopic deployment into the body. Fig. 20B Shows Fig. 20A The handle of the non-ablative needle is shown. The end portion 2020 engages the endoscope. The handle 2021 controls the length of the catheter that can be moved in and out of the endoscope. The handle 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 lumen of the needle to help keep the coil in the martensitic shape, and also accommodates a pusher catheter to push the coil out of the needle.

[0259] Fig.21A cautery needle device 2100 is shown according to an embodiment of the present specification, which is used to deliver an SMA coil 2104 in a body via an endoscope. The cautery needle device 2100 includes a port 2108, a body 2110, a handle 2106, a distal end 2112, a needle 2102, and an electrosurgical attachment 2107, and is used to deliver an SMA stapling coil 2104 into a human body via an endoscope. The body 2110 of the needle device 2100 is inserted into a human body via an instrument channel of an endoscope so that the distal end 2112 extends beyond the distal end of the endoscope. The needle 2102 extends from the distal end 2112 of the device 2100 via the operation of the handle 2106 for puncturing a desired 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 pusher catheter. The SMA coil 2104 is delivered through the puncture site by a pusher catheter which is inserted into the port 2108 and pushes the coil 2104 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 at its distal tip 2112 for positioning the tip 2112, bringing the two lumens closer together and aiding in the deployment of the coil 2104. The pusher tube has a marker or stop mechanism built into it for assessing the amount of coil that has been pushed out of the catheter.

[0260] Fig. 22A cautery needle device 2200 according to an embodiment of the present specification is shown, which is used to deliver an SMA coil 2204 into the body via an endoscope with the assistance of a guide wire 2206. The cautery needle device 2200 includes a handle 2208, a body 2212, a first port 2210 for cold saline injection, a second port 2214 for passing a guide wire, a distal end 2221, a needle 2202, and an electrosurgical attachment 2207, and is used to deliver an SMA stapling coil 2204 into the human body via an endoscope with the assistance 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 end 2221 extends beyond the distal end of the endoscope. The needle 2202 extends from the distal end 2221 via the operation of the handle 2208 to puncture the target tissue. Electrocautery is used to assist in such puncture. The guide wire 2206 is inserted into the body 2212 of the needle device 2200 via the second port 2214 and extends from the distal end 2221 to the punctured organ for maintaining position / intervention, for guiding the placement of the catheter end 2221 and the SMA coil 2204 at the desired position. The SMA coil 2204 is delivered to the lumen punctured by the needle 2202 by a pusher catheter, which is introduced via the first port 2210 and pushes a portion of the coil 2204 out of the distal end 2221 and into the lumen of the second organ. The end 2221 is withdrawn into the lumen of the first organ and the remaining coil is deployed. The coil then changes shape and fixes the two walls of the two organs together, allowing the two walls to fuse, and then cuts out an anastomosis with a predetermined shape and size.

[0261] Fig.23A A release mechanism for releasing the SMA coil 2304 from the delivery catheter 2300 is shown according to an embodiment of the present specification. The coil coupling member 2302 at the end of the SMA coil 2304 to be deployed is attached to the delivery coupling member 2306 on the pusher element 2308 to allow the coil 2304 to move in and out of the 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 change the configuration between a first open configuration and a second closed configuration. The handle 2312 is configured to push the pusher element 2308 in and out. Fig. 23B According to the embodiment of this specification, Fig.23A The delivery catheter 2300 is shown with the SMA coil 2304 released. The handle 2312 is pushed forward while holding the sheath 2310. As shown, as the coil 2304 is pushed out of the catheter sheath 2310, the delivery coupling member 2306 on the pusher 2308 or the coil 2304 or both opens, allowing the coil 2304 to be disengaged from the pusher 2308 and the catheter 2300.

[0262] Fig.24A A release mechanism for releasing an SMA coil 2404 from a delivery catheter 2400 is shown according to another embodiment of the present specification. The coil coupling member 2402 at the end of the SMA coil 2404 to be deployed is attached to the delivery coupling member 2406 on the pusher element 2408 to allow the coil 2404 to move in and out of the 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 change the structure between a first open structure and a second closed structure. The handle 2412 is configured to push the pusher element 2408 in and out. Fig. 24B According to the embodiment of this specification, Fig.24A The delivery catheter 2400 is shown with the SMA coil 2404 released. The handle 2412 is pushed forward while the sheath 2410 is held. As shown, as the coil 2404 is pushed out of the catheter sheath 2410, the delivery coupling member 2406 on the pusher 2408 opens, allowing the coil 2404 to be disengaged from the pusher 2408 and the catheter 2400. In one embodiment, the pusher 2408 includes a stop mechanism to inform the user when a portion (less than the full length) of the coil 2404 has been released from the catheter 2410. In another embodiment, the pusher 2408 includes a stop mechanism to prevent the user from accidentally deploying the full length of the coil 2404 from the catheter 2410 at any time.

[0263] Fig.252502, in order to form an anastomosis between a first organ and a second organ, first, adjacent walls of the two organs are identified by endoscopy. 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 via a hollow needle or catheter having an inner cavity for carrying the SMA wire and using an endoscope, and the SMA wire can be coupled to a magnet. In step 2506, the identified organ wall is punctured, and a portion of the SMA wire is deployed in the inner cavity of the first organ, and the remaining coils are deployed in the inner cavity of the second organ. In step 2508, when exposed to body heat, the relatively straight SMA wire curls to its predetermined austenitic shape and squeezes adjacent organs together. At step 2510, the loops of the coil and / or magnets (if included) slowly cut through the walls of the two adjacent organs over time, forming an anastomosis together, and the compressive force is increased due to the attractive force between the magnets positioned on the adjacent loops of the SMA coil. As the loops of the coil and / or magnets cut through the walls of the two organs, the attractive force increases over time, thereby bringing the magnets closer to each other. At step 2512, once the coil has completely cut through the walls of the two organs, forming a stable anastomosis, the coil falls off spontaneously and passes through the body naturally, or it can be removed using an endoscope or any other minimally invasive technique. In some embodiments, the coil is specifically shaped to facilitate its passage in a specific direction.

[0264] Fig.26A , 26B 26C show first, second and third views of an exemplary device 2600 for forming anastomosis in a relatively straight pre-curled configuration, respectively. The device includes a shape memory alloy (SMA) wire 2602 having a plurality of magnets 2604 and a spacer 2606 coaxially positioned around the wire 2602. In one embodiment, the wire 2602 includes nitinol. In one embodiment, the spacer 2606 includes a non-ferromagnetic material. In various embodiments, the spacer 2606 includes silicone, Teflon, PTFE, or a nitinol tube or an O-ring or a sphere. 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. Figures 26A-26C Device 2600 is shown in a pre-crimped or pre-deployed configuration. Device 2600 has a curved shape when at room temperature and not constrained by a delivery catheter. Device 2600 has a curved shape when constrained by a delivery catheter (e.g., see Fig.15A The device 1500) has an almost straight shape.

[0265] Fig.26D and 26EA side view and an axial view are shown, respectively, of the device 2600 for forming a Fig.26A After deployment, and when exposed to body temperature, the SMA wire coil allows the device 2600 to Figures 26A-26C The curved structure shown moves to Fig.26D and 26E The curled configuration shown. Spacers 2606 ensure that magnets 2604 do not bunch together on device 2600. See Fig.26D , the magnetic attraction between the magnets 2604 on adjacent loops 2607a, 2607b, 2607c of the curled device (e.g., magnets 2604a, 2604b, 2604c on adjacent loops 2607a, 2607b, 2607c) is used to pull the loops 2607a, 2607b, 2607c together and tighten the coil.

[0266] Fig.26F A first exemplary device 2610 is shown for forming an anastomosis in a conical coil configuration after deployment according to one embodiment of the present specification. The device 2610 is configured to pass through the tissue in only one direction after the anastomosis is formed. The device 2610 includes a single shape memory wire that takes the shape of a coil 2613 once deployed. The device 2610 includes a loop 2618 having a larger diameter at a first end 2611 of the coil 2613 than a loop 2619 at a second opposite end 2612 of the coil 2613. The diameter of the cut loops 2618, 2619 of the coil 2613 determines the diameter of the anastomosis. Therefore, the anastomosis finally formed 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 has been 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 loop 2619 and the device end 2612.

[0267] Figure 26GA second exemplary device 2620 is shown for forming anastomosis in a conical coil configuration after deployment according to one embodiment of the present specification. The device 2620 is configured to pass through the 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 loop 2628 at a first end 2621 of the device 2620 and having a larger diameter than the loop 2629 at the second opposite end 2622 of the device 2620. The diameter of the cutting loops 2628, 2629 of the device 2620 determines the diameter of the anastomosis. Therefore, the anastomosis finally formed will also have a conical or funnel shape, with a larger opening at the first end associated with the first end 2621 of the device 2620, and a smaller opening at the second end associated with the second end 2622 of the device 2620. Once the anastomosis has been 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 loop 2629 and the device end 2622.

[0268] Fig.26H An embodiment of a device 2630 for forming an anastomosis is shown in a post-deployment coil configuration and includes a single flange 2637 attached to one end 2631 of the coil 2633. The device 2630 includes a coil 2633 having a first end 2631 and a second opposite end 2632 and includes 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 further includes an extension or flange 2637 having a first end 2638 and a second end 2639. In one embodiment, the flange 2637 is conical in shape. The second end 2639 of the flange 2637 is attached to the flange 2637 of the first end 2631 of the coil 2633. The first end 2638 of the flange 2637 has a diameter that is greater than the diameter of the second end 2639 of the flange 2637 and greater than the diameters of the two ends 2631, 2632 of the coil 2633. Once the anastomosis has been formed, the device will only pass in the direction indicated by the arrow 2634 (the direction including the ends 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.

[0269] Fig.26I and 26JAn end view and a side view of another embodiment of a device 2640 for forming an anastomosis in a deployed coil configuration are shown, 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 a second opposite end 2642 and includes 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 further 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 the end of the flange 2647 via 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 angular protrusions 2648 extending outwardly from the center of the device 2640 such that the diameter defined by the outer edges of the protrusions 2648 is larger than the diameter of the two ends 2641, 2642 of the coil 2643. Once the anastomosis has been formed, the device will only pass in the direction indicated by arrow 2644 (a direction that includes the ends of the flange) because the relatively larger diameter of the protrusions 2648 of the flange 2647 will prevent the flange 2647 from passing through the anastomosis formed by the relatively smaller diameter of the coil 2643.

[0270] Figure 26KAn embodiment of a device 2650 for forming an anastomosis is shown in a post-deployment coil configuration and includes a flange 2657, 2667 attached to each end of a coil 2653. The device 2650 includes a coil 2653 having a first end 2651 and a second opposite end 2652 and includes a plurality of magnets 2655 separated by a plurality of spacers 2656 positioned on a shape memory wire. In an 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 further includes a first extension of the flange 2667 or a flange 2657 and a second extension, each of which has a first end 2661, 2671 and a second end 2662, 2672. In an embodiment, each flange 2657, 2667 is conical in shape. 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 each has a diameter that is larger than the diameter of each second end 2662, 2672 of the flanges 2657, 2667 and larger than the diameter of both ends 2651, 2652 of the coil 2653. Once the anastomosis has been formed, the device 2650 will become fixed in the anastomosis and cannot pass through it 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 on both ends, and after the anastomosis is formed, the coil 2653 will not spontaneously pass through the anastomosis because the flanges 2657, 2667 will be stuck.

[0271] Figure 26L , 26M26N show end and side views of another embodiment of a device 2680 for forming an anastomosis in a deployed coil configuration, 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 a second opposite end 2682 and includes 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 further 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 via 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 angular 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 has been formed, the device 2680 will become fixed in the anastomosis and cannot pass through it because the relatively large diameter of the protrusions 2688, 2698 of the flanges 2687, 2697 will prevent the device 2680 from passing through the anastomosis formed by the relatively small diameter of the coil 2683 in either direction. The coil 2680 will not pass through spontaneously after the anastomosis is formed.

[0272] Fig.26O A mold 2690 is shown for forming a Figure 26L The anastomosis device 2680 of the flange of the mold 2690. The mold 2690 includes a first plurality of pins 2691 and a second plurality of pins 2692 extending vertically from the base 2693 of the mold 2690. The first plurality of pins 2691 are positioned at a first distance 2695 from the center 2694 of the mold 2693 and the second plurality of pins 2692 are positioned 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. See also Figures 26L to 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 to give the coil 2683 its coil shape. Each flange 2687, 2697 is wound in a clockwise direction (or in a counterclockwise direction in another embodiment) 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 to form a star-shaped or flower-shaped flange.

[0273] Fig. 27 An SMA coil device 2702 (with a delivery catheter 2706) for forming an anastomosis is shown in a pre-deployment configuration according to an embodiment of the present specification. A cautery loop 2704 formed at the distal end of the SMA coil 2702 device is used to puncture the target tissue and cauterize the tissue when forming an opening for the anastomosis. 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, which causes the coil to change shape and fix the two walls of the two organs together. The SMA coil device 2702 is attached to a loop / joint gripper 2712 on the pusher element 2714 of the delivery catheter 2706 to allow the coil device 2702 to move in and out of the delivery catheter sheath 2716. A handle 2718 is provided for pushing the pusher element 2714 in and out. In one embodiment, the electrosurgical unit connector 2720 provides electrical contact between the pusher element 2714 and the SMA coil assembly 2702 and an electrosurgical generator.

[0274] Fig.28An SMA coil device 2800 (having a delivery catheter 2820) for forming anastomosis in a pre-deployment configuration according to another embodiment of the present specification is shown. The SMA coil device 2800 includes a cautery loop 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 loop 2804 is used to puncture the target tissue and cauterize the tissue when the opening is formed for forming anastomosis. In one embodiment, the SMA wire 2802 includes Nitinol. In one embodiment, the spacer 2808 includes 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 loop 2810 at the proximal end of the SMA wire 2802 is attached to a loop / joint gripper 2812 on a pusher element 2814 to allow the SMA wire 2802 to move in and out of a delivery catheter sheath 2816 of a delivery catheter 2820. In one embodiment, the SMA wire 2802 includes an insulating cover 2803. In various embodiments, the insulating cover 2803 includes silicone or Teflon. When the cautery loop 2804 is heated by the current conducted to the SMA wire 2802 through the pusher element 2814 and the loop / joint gripper 2812, the insulating cover 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 in an outer catheter 2818 at the distal end of the delivery catheter 2820.

[0275] Fig.29A A cautery tip 2902 is shown for deployment with an anastomosis coil device in accordance with various embodiments of the present specification. The cautery tip 2902 is configured to receive thermal energy from an electric current source. As the cautery tip heats, it advances forward into body tissue. The thermal energy cuts through the target tissue, forming an opening for forming an anastomosis while cauterizing and stopping blood loss from tissue surrounding the newly formed opening. Fig.29BAn anastomotic coil device 2900 provided with a cautery head 2902 in a pre-deployment configuration according to an embodiment of the present specification is shown. The anastomotic coil device 2904 is detachably connected to a pusher 2907, which includes a cautery wire 2906, by a threaded connector 2908 at the proximal end of the anastomotic coil device 2904, the threaded connector forming 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 thereabout. In an embodiment, the SMA wire 2904 includes Nitinol. The SMA wire 2904 extends distally through the lumen 2903 of the cautery head 2902. A metal cylinder 2916 is positioned in the distal end of the lumen 2903 of the cautery head 2902. The SMA wire 2904 further extends through the lumen 2905 of the metal cylinder 2916 at the distal end. The rivet 2914 connects the metal cylinder 2916 to the SMA wire 2904 at the distal end of the cautery head 2902. An additional wire 2918 is connected to the rivet 2914 and, in various embodiments, extends along the outer surface of the cautery head 2902. Electric current is provided via the cautery wire 2906 and passes through the threaded connector 2908, flows along the SMA wire 2904, and reaches the metal cylinder 2916 and the wire 2918. The current forms thermal energy in the metal cylinder 2916 and the wire 2918, which is transmitted to the cautery head 2902, which includes ceramic or PEEK in various embodiments. The thermal energy heats the cautery head 2902, which is used to puncture and cauterize tissue to form an opening for anastomosis formation. After deployment of the anastomotic coil device 2900 , the pusher 2907 with the cautery wire 2906 is detached from the SMA wire 2904 .

[0276] Fig. 30AA side cross-sectional view of an anastomotic coil device 3000 with a distal cautery tip 3002 in a pre-deployment configuration according to an embodiment of the present specification is shown. In one embodiment, the cautery tip 3002 comprises a ceramic 'hot tip' coupled to a cautery electrode 3004. The ceramic hot tip design allows the catheter to penetrate into the wall of an organ. In one embodiment, the length of the ceramic tip 3002 and the cautery electrode 3004 is approximately 7.4 mm. A stainless steel support wire 3008 and a clamping tube 3010 couple the cautery 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 cautery tip 3002 and a proximal stop 3022, which is attached to the proximal end of the nitinol wire 3012 and is detachably coupled to the steel pusher catheter 3020. Current flows from the pusher catheter 3020 through the nitinol wire 3012 and the stainless steel wire 3008 and into the cautery tip 3002 and the electrode 3004, heating the cautery tip 3002 to achieve electro-cautery puncture of the target tissue.

[0277] Fig. 30B Shows Fig. 30A 3030 in the enlarged view of the portion marked. In one embodiment, the diameter of the nitinol wire 3012 and each magnet 3014 is 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 3040 in the enlarged view of the portion marked. In one embodiment, the length of each magnet 3014 is about 2.5 mm.

[0278] Fig.30D Shows that there is Fig. 30A Another view of a stapling coil device that enables cautery is shown with a cautery tip. The cautery tip 3002 is coupled to a nitinol wire (not visible in the figure) covered by 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 pusher catheter 3020 and the proximal stop 3022 of the anastomotic coil device is shown. The proximal stop is removably coupled to the steel pusher catheter 3020 which allows current to flow through the nitinol wire to the cautery tip.

[0279] Fig.30F Shown with Fig. 30A A close up view of a cautery head 3002 coupled to a cautery electrode 3004 of an 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 generally circular cross-section with a circular opening 3006 in the center for receiving a cautery electrode 3004. Fig. 30H Shows Fig.30F A side cross-sectional view of the cautery tip 3002 and cautery electrode 3004 is shown. Fig. 30I Shows Fig.30F The cautery electrode 3004 is shown. As shown, the electrode 3004 is generally cylindrical and fits into a circular opening 3006 provided at the distal end of the cautery head 3002. In one embodiment, a support wire 3008 forms a loop at the distal end of the cautery head 3002 and assists in securing the electrode 3004 in place and electrocautery puncture of an organ. Current travels along the wire 3008 to heat the electrode 3004. The heat energy is transmitted to the cautery head 3002, which is then used to puncture and cauterize the target tissue to form an opening for forming an anastomosis.

[0280] Fig.31A A three-lumen catheter for delivering an anastomotic coil device according to an 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 configured 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 guidewire 3110 encapsulated in a catheter 3108 for delivering the stapling coil device 3100 in a pre-deployment configuration according to an embodiment of the present specification is shown. A plurality of magnets 3102 and spacers 3104 are coaxially positioned around an SMA wire 3106, as shown. In one embodiment, the wire 3106 comprises nitinol. In one embodiment, the spacer 3104 comprises 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 some embodiments, 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. The catheter 3108 (similar to Fig.31A The anastomotic coil device 3100 is delivered through a first lumen in a catheter 3108 (shown in the figure), while a guide wire 3110 for guiding the anastomotic coil device 3100 to be placed at a desired location in the body is positioned in a second lumen of the catheter 3108. The anastomotic coil device 3100 is pushed out of the catheter 3108 by a pusher tube 3114. A cautery wire (not shown) may optionally be passed through a 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 puncturing and cauterizing the target tissue. Fig.31C Shown along Fig.31B As shown, the first lumen 3101 for the stapling coil device, the second lumen 3103 for the guide wire, and the third lumen or keyhole 3105 for the cautery wire each have a circular cross-section. 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 about 2 mm and the diameter of the catheter 3108 is about 3.5 mm. Fig.31E Shown is the Fig.31B Another view of the catheter 3108 for delivery of the anastomotic coil device and the guidewire. As shown, the catheter 3108 partially encloses the guidewire 3110 and a connector 3116 for connecting to a monopolar endoscope cable, which is disposed in a third lumen or keyhole ( Fig.31C In one embodiment, the diameter of the guide wire 3110 is about 0.5 mm and the diameter of the connector 3116 is about 0.5 mm.

[0281] Fig.32A A cross-sectional view of an anastomotic coil device 3200 in a pre-deployment configuration disposed in a delivery catheter 3208 according to another embodiment of the present specification is shown. The anastomotic coil device 3200 includes a plurality of magnets 3202 and a spacer 3204 coaxially positioned around an SMA wire 3206 as shown. In one embodiment, the wire 3206 includes Nitinol. In one embodiment, the spacer 3204 includes 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 (made of PEEK or Teflon in some embodiments) encloses the anastomotic coil device 3200 and is coupled to a conductor head 3210 (made of ceramic or PEEK in some embodiments) at a distal end for puncturing an organ by using an electro-cautery action. At the proximal end, the anastomotic coil device 3200 is coupled to a pusher tube 3212 as shown. 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 some embodiments, 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 ends are detachably coupled to the pusher tube 3212, allowing the stapling coil device 3200 to be released from the catheter 3208. In one embodiment, the length of each stop mechanism 3216 is 1.5 mm. Fig.32B Shown along Fig.32ABB axis as shown. As shown, the outer catheter 3208 and the conductor head 3210 have circular cross-sections and diameters of approximately 3.3 mm and 2.2 mm, respectively. Further, the conductor wire 3214 passes along the length of the catheter 3208 and is positioned proximal to the conductor head 3210. The current supplied to the conductor wire 3214 is converted into heat energy in the conductor head 3210, which facilitates electrocautery through the conductor head 3210 and punctures the target tissue for anastomosis formation. Fig.32C Shown along Fig.32A 32. 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 conductor wire 3214 is shown as extending through the second lumen 3203 in the wall of the catheter 3208. Fig.32D Shown along Fig.32A As shown, in one embodiment, the pusher tube 3212 has a circular diameter of about 1.9 mm and is disposed in the first lumen 3201. Also, in one embodiment, the conductor wire 3214 has a circular cross-section and a diameter of about 0.25 mm and is disposed in the second lumen 3203, which in one embodiment has a diameter of 0.30 mm.

[0282] Fig.32E Shows Fig.32A An enlarged view of the conductor head 3210 is shown. The outer conduit 3208 partially encapsulates the conductor wire 3214 and the conductor head 3210, as shown in FIG. Fig.32E In one embodiment, the conductor wire 3214 is welded to the conductor head 3210. In one embodiment, the conductor head has a cylindrical portion 3220 with a flange 3222 about 2.5 mm long protruding around the circular portion, as shown. In one embodiment, the inner and outer diameters of the conductor head 3210 are about 2.2 mm and 2.4 mm, respectively. Fig.32F Shown in a post-deployment configuration after delivery into the body Fig.32A The anastomotic coil device 3200 is shown. As shown, after delivery, the wire 3206 is coiled, trapping body tissue in the coils of wire and magnets 3202 for creating 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. Magnets 3202 are shown aligned along the same plane in the post-deployment configuration of device 3200. Fig.32H Shown as Fig.32BThe O-ring of the spacer 3204 is provided. 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.

[0283] Fig.33A A dual handle delivery device 3300 is shown for delivering an anastomotic coil device 3308 provided with a cautery head 3318, in accordance with an 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 an electrical current to the cautery head 3318 of the anastomotic coil device 3308. The anastomotic coil device 3308 having the cautery head 3318 is positioned in the inner catheter 3312. The first handle 3302 and the second handle 3310 operate relative to each other to deploy the anastomotic coil device 3308. Fig.33B Shows Fig.33A An enlarged view of the electrosurgical connection 3316 and the second handle 3310 is shown.

[0284] Fig.34A A cross-sectional view of a dual-handle delivery device 3400 according to an embodiment of the present specification is shown, which is used to deliver an anastomotic coil device provided with a cautery head 3402. The anastomotic coil device including the cautery head portion 3402 is delivered via 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 view of the head portion 3402 is shown. The head portion 3402 includes a ceramic head 3408 that encloses a cauterization electrode 3410. A guide wire 3412 passes through the ceramic head 3408 from its proximal end and extends from the distal end of the ceramic head 3408 near 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, which is enclosed in an inner tube 3416 made of 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 connected to the ceramic head 3408 by using ultraviolet glue. In one embodiment, the inner tube 3416 is connected to the guide wire support 3414 using ultraviolet glue. Fig.34C Shows Fig.34B A cross-sectional view of the distal 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.

[0285] Fig.34D Shows Fig.34A An enlarged 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 34E , the guide wire support 3414 is enclosed in the inner tube 3416, which is in turn 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, while the guide wire support 3414 passes through the other lumen of the double lumen tube 3418, such as 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.

[0286] Fig.34F Shows Fig.34A FIG. 34 is an enlarged view of the handle portion 3406 shown. The handle portion 3406 includes a conductive plug / pin 3422 and a transparent knob tail 3424. The conductive plug / pin 3422 is in electrical communication with the guide wire 3412 for providing electrical contact to the guide wire 3412. Fig.34B Electrode 3410 delivers current.

[0287] Fig.35 35 is a flowchart showing the steps of forming anastomosis by using a magnetic extrusion force between a shape memory wire and an adjacent organ or structure according to an embodiment of the present specification. In step 3502, in order to form anastomosis between a first organ and a second organ, first, an endoscope is placed in the lumen of the first organ. In step 3504, an adjacent second organ is identified using endoscopy, fluoroscopy or ultrasound imaging technology. In 3506, the walls of the first and second organs are punctured by using a catheter passing through the endoscope or beside the endoscope to reach the lumen of the second organ. In step 3508, the portion of the shape memory wire including the magnet is deployed in the lumen of the second organ and the wire is transformed from a straight shape to a curled shape. In step 3510, the catheter is pulled back into the lumen of the first organ, and the rest of the shape memory wire including the magnet is deployed in the lumen of the first organ and the wire is transformed from a straight shape to a curled shape. In step 3512, the adjacent walls of the first and second organs are squeezed due to the squeezing force formed by the coil, and the squeezing force increases over time to cause a squeezed anastomosis.

[0288] Fig.3636 is a flowchart showing the steps of forming anastomosis by using a shape memory coil with a magnet between adjacent organs according to an embodiment of the present specification. In step 3602, in order to form anastomosis between a first organ and a second organ, first, an endoscope is placed in the lumen of the first organ to expand the lumen by a gas or a fluid and allow the gas or fluid to flow into the lumen of the adjacent second organ. In step 3604, an adjacent second organ is identified using endoscopic or ultrasound imaging techniques, wherein the gas or fluid assists the identification. In 3606, the walls of the first and second organs are punctured by using a catheter passing through or beside the endoscope to reach the lumen of the second organ. In step 3608, the portion of the shape memory wire including the magnet is deployed in the lumen of the second organ and the wire is transformed from a straight shape to a curled shape. In step 3610, the catheter is pulled back into the lumen of the first organ, and the remaining portion of the shape memory wire including the magnet is deployed in the lumen of the first organ and the wire is transformed from a straight shape to a curled shape. At step 3612, adjacent walls of the first and second organs are compressed due to the compression force formed by the coil, and the compression force increases over time to create a compression anastomosis.

[0289] Fig.37 3702, in order to form an anastomosis between a first organ and a second organ, first, an endoscope is placed in 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 punctured by using a catheter passing through the endoscope or beside the endoscope to reach the lumen of the second organ. In step 3708, the portion of the shape memory wire including the magnet is deployed in the lumen of the second organ and the wire is transformed from a straight shape to a curled shape. In step 3710, the catheter is pulled back into the lumen of the first organ, and the rest of the shape memory wire including the magnet is deployed in the lumen of the first organ and the wire is transformed from a straight shape to a curled shape. In step 3712, the adjacent walls of the first and second organs are squeezed due to the squeezing force formed by the coil, and the squeezing force increases over time to cause a squeezed anastomosis. At step 3714, once the anastomosis is formed, the shape memory coil spontaneously falls off and is naturally cleared from the body.

[0290] Fig.3838 is a flowchart showing the steps of forming anastomosis by using a shape memory coil with a magnet between adjacent organs according to an embodiment of the present specification. In step 3802, in order to form anastomosis between a first organ and a second organ, first, an endoscope is placed in the lumen of the first organ to expand the lumen by gas or fluid and allow the gas or fluid to flow into the lumen of the adjacent second organ. In step 3804, an adjacent second organ is identified using endoscopic or ultrasound imaging techniques, wherein the gas or fluid assists in the identification. In 3806, the walls of the first and second organs are punctured by using a catheter passing through or beside the endoscope to reach the lumen of the second organ. In step 3808, the portion of the shape memory wire including the magnet is deployed in the lumen of the second organ and the wire is transformed from a straight shape to a curled shape. In step 3810, the catheter is pulled back into the lumen of the first organ, and the remaining portion of the shape memory wire including the magnet is deployed in the lumen of the first organ and the wire is transformed from a straight shape to a curled shape. At step 3812, the adjacent walls of the first and second organs are compressed due to the compression force formed by the coil, and the compression force increases over time to create a compressed anastomosis. At step 3814, once the anastomosis is formed, the shape memory coil is retained in the anastomosis until it is removed from the body by using an endoscope.

[0291] Fig.39A An exemplary magnet 3902 of a device for forming anastomosis according to an 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 about 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 of 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 about 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 about 2.318N. Fig.39A The force between the cylindrical surfaces 3902a, 3902b of magnet 3902 is approximately 191%.

[0292] As mentioned above, the coil structure of the anastomotic device of the present specification allows the application of multiple magnetic layers (or coil loops), thereby increasing the squeezing force on the tissue surface without increasing the complexity of the medical process. The magnetic anastomotic device undergoes separation due to the force of the gastrointestinal tract. The separation possibility limited by the distance between the loops of the curling device depends on the size of the magnet in the device, the number of coils or loops, and the radius of the coil. Because the embodiment of the anastomotic device of the present specification includes multiple coil loops on both sides of the anastomotic portion being formed, these coil loops are less likely to separate than the single loop, separate and physically separated device of the prior art. In addition, because the embodiment of the present specification includes a single integrated device, if the first magnetic element on the first coil loop is attached to the second magnetic element on the second coil loop, the two magnetic elements are subsequently separated, then the separation will only be temporary and the two magnetic elements will automatically reattach on the target tissue area without human intervention. In other words, the magnetic coil loops cannot be separated far from each other because they are attached to a single device, and they will finally reattach due to magnetic force.

[0293] The following shows the effects of magnet size, number of coil loops, and coil radius on the deployed magnetic stapling device of the present specification and the ultimate possibility of stapling separation (separation of two adjacent tissues). In operation, the device having a plurality of magnets in fixed relationship to each other is positioned endoscopically near a tissue wall; the tissue wall is punctured by 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 some of the plurality of magnets on one side of the tissue wall and some of the plurality of magnets on the other side of the tissue wall; after the first group of the plurality of magnets is formed into at least one coil and the second group of the plurality of magnets is formed into at least one second coil (which will occur automatically without further human intervention), a waiting period of time is performed. While forming the coils, the first group and the second group of the plurality of magnets (each of which has a diameter ranging from 1 mm to 4 mm, preferably 2 mm to 3 mm) attract each other and move toward each other automatically, thereby squeezing a tissue wall of about 10 to 15 mm thick to a size of 2 mm to 8 mm thick, depending on the type of tissue being targeted.

[0294] In the case of the following examples, magnets with a maximum diameter of up to 3 mm are used to accommodate endoscopic delivery. In other embodiments, the anastomotic devices of the present specification have a maximum diameter of up to 7 mm. In some embodiments, the magnets are N52 magnets and each has a surface magnetic field of 10,000 to 20,000 Gauss, preferably 14,800 Gauss. In addition, several assumptions are made about the magnetic device, the human anatomy, and the forces formed by the device and the anatomy:

[0295] The standard cumulative thickness of the two walls to be anastomosed is assumed to be 8-10 mm.

[0296] • The ideal magnetic force for anastomosis formation is 0.1-0.3 N and the ideal pressure for anastomosis formation is 14.5-58 psi (0.1-0.4 MPa), but the disclosed range for pressure applied by the device is 1-145 psi (0.007-1 MPa).

[0297] The average cumulative stress in the human stomach during the first 30 minutes of gastric emptying is 160,000 ± 70,000 dynes / cm 2 (0.016±0.007MPa)(fasting) and 520000±270000 dyne / cm 2 (0.052±0.027MPa)(eating).

[0298] The small intestine can generate pressures greater than 1.93 psi (100 mmHg; 0.013 MPa).

[0299] The average normal stomach wall thickness is 5.1±1.1mm, and the maximum thickness is 7mm.

[0300] The average normal small intestinal wall thickness is as follows:

[0301] ○Duodenum: 1.53±0.58mm.

[0302] ○Jejunum: 1.50±0.55mm.

[0303] ○Ileum: 1.61±0.47mm.

[0304] The average normal gallbladder wall thickness is 2.6±1.6mm, and the maximum thickness is 4mm.

[0305] The average gallstone thickness was 0.4±1.4 mm.

[0306] The average gallbladder sludge thickness was 0.5±1.4 mm.

[0307] The mean wall thickness of the gallbladder in patients with acute cholecystitis was 3.1 ± 1.6 mm.

[0308] The average common bile duct wall thickness was 0.8±0.4mm.

[0309] Case 1: Device with one coil loop on each side of the anastomosis

[0310] Fig.39C is a graph showing the relationship between the distance between coil loops and the compression pressure provided by a stapling device according to an embodiment of the present specification, the stapling device having a single coil loop on each side of the stapling to be formed. In other words, Fig.39CEach device shown includes a total of one pair of coil loops, which include a single coil loop on each side of the anastomosis to be formed. Curves 3910, 3911 and 3912 show the relationship between the distance between the coil loops and the pressure for a device having 1 pair of coil loops, an inner 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 peristaltic properties of the gastrointestinal tract will produce a maximum stomach pressure 3913 of about 7.25 psi (0.05 MPa) and a maximum small intestinal pressure 3914 of about 1.88 psi (0.013 MPa). As shown in FIG. Fig.39C As shown, the pressure (P) formed by the anastomotic device increases as the distance (d) between the coil loops decreases. In addition, the pressure formed increases as the width of the magnet increases. For example, curve 3912 shows that a device including a magnet with a width of 3.0 mm has a pressure of about 7.25 psi (0.05 MPa) at a distance of about 0.36 cm, and in comparison, curve 3910 shows that a device including a magnet with a width of 2.0 mm has a pressure of about 3.63 psi (0.025 MPa) at the same distance.

[0311] To form a gastric anastomosis, a device comprising 2 mm or 3 mm diameter magnets, respectively, needs to reach a distance of no more than 2 mm to 4 mm between the loops and therefore between the magnets, so that the gastric pressure cannot separate the loops. To form a small intestinal anastomosis, a device comprising 2 mm or 3 mm magnets, respectively, needs to reach a distance of no more than 6 mm to 8 mm between the loops and therefore between the magnets, so that the small intestinal pressure cannot separate the loops. The cumulative thickness of the organ wall is assumed to be greater than 10 mm.

[0312] As the distance between the coil loops increases, the pressure developed 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 is at risk of separation. Once each curve 3910, 3911, 3912 is below the assumed maximum gastric pressure 3913, each gastric anastomosis is at risk of separation. That is, due to gastric pressure, the gastric anastomosis is at risk of separation. Fig.39C Each gastric anastomosis formed by the device shown has a risk of separation at a distance ranging from at least 0.36 cm to 1 cm. Box 3916 shows the risk of separation at a distance ranging from at least 0.36 cm to 1 cm. Fig.39C The distance at which the small intestinal anastomosis formed by the device shown is at risk of separation. Once each curve 3910, 3911, 3912 is below the assumed maximum small intestinal pressure 3914, each small intestinal anastomosis is at risk of separation. Fig.39CEach small intestinal anastomosis formed by the device shown is at risk of separation at a distance ranging from at least 0.8cm to 1cm. Therefore, assuming that the magnet diameter is 3.0mm and the interval is less than 3.6mm, gastric peristalsis will not be enough to separate the magnet and / or expel it. Assuming that the magnet diameter is 3.0mm and the interval is less than 8mm, small intestinal peristalsis will not be enough to separate the magnet and / or expel it. As previously mentioned, the single device structure of the anastomotic device of the present specification allows them to automatically reattach in the event of separation and correct orientation. Because the prior art devices require two separate devices to be anastomosed, these devices are at risk of spontaneous separation at the distance shown in frames 3915 and 3916, and ultimately cause removal without reattachment.

[0313] Case 2: Device with two coil loops on each side of the anastomosis

[0314] Fig.39D is a diagram showing the relationship between the distance between coil loops and the extrusion pressure provided by a stapling device according to an embodiment of the present specification, the stapling device having two coil loops on each side of the stapling to be formed. In other words, Fig.39D Each device shown includes a total of two pairs of coil loops, each pair of loops including a single coil on each side of the anastomosis to be formed, for a total of 4 loops. Curves 3920, 3921 and 3922 show the relationship between the distance between the coil loops and the pressure for a device having 2 pairs of coil loops, an inner 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 peristaltic properties of the gastrointestinal tract produce a maximum stomach pressure 3923 of about 7.25 psi (0.05 MPa) and a maximum small intestinal pressure 3924 of about 1.88 psi (0.013 MPa). As shown in FIG. Fig.39D As shown, the pressure (P) formed by the anastomotic device increases as the distance (d) between the coil loops decreases. In addition, the pressure formed increases as the magnet width increases. For example, curve 3922 shows that the device including a 3.0mm magnet of width has a pressure of about 7.25psi (0.05MPa) at a distance of about 0.55cm, and in comparison, curve 3920 shows that the device including a 2.0mm magnet of width has a pressure of about 3.63psi (0.025MPa) at the same distance. In order to form a gastric anastomosis, the device including a 2mm to 3mm magnet needs to reach a distance of no more than 3.5mm to 6mm between the loops and therefore between the magnets, so that the gastric pressure cannot separate the loops. In order to form a small intestinal anastomosis, the device including a 2.5mm to 3mm magnet cannot be separated by the small intestinal pressure, and the device including a 2mm magnet needs to reach a distance of no more than 8mm between the loops and therefore between the magnets, so that the small intestinal pressure cannot separate the loops. The cumulative thickness of the organ wall is assumed to be greater than 10mm.

[0315] As the distance between the coil loops increases, the pressure developed by the device decreases and the risk of anastomotic separation increases. Fig.39D The distance at which the gastric anastomosis formed by the device shown is at risk of separation. Once each curve 3920, 3921, 3922 is below the assumed maximum gastric pressure 3923, each gastric anastomosis is at risk of separation. That is, due to gastric pressure, the gastric anastomosis is at risk of separation. Fig.39D Each gastric anastomosis formed by the device shown has a risk of separation at a distance ranging from at least 0.54 cm to 1 cm. Box 3926 shows the risk of separation at a distance ranging from at least 0.54 cm to 1 cm. Fig.39D The distance at which a small intestinal anastomosis formed by the device shown is at risk of separation. Curves 3921 and 3922 (representing devices having diameters of 2.5 mm and 3 mm, respectively) do not enter below the assumed maximum small intestinal pressure 3924, and as such, these devices do not experience separation. Once curve 3920 is below the assumed maximum small intestinal pressure 3914, a small intestinal anastomosis formed by a device having a magnet having a diameter of 2.0 mm is at risk of separation. That is, due to small intestinal pressure, a small intestinal anastomosis formed by a device having a magnet having a diameter of 2.0 mm is at risk of separation at distances ranging from 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 will not be sufficient to separate and / or expel the magnet. Assuming that the magnet diameter is 3.0 mm and the normal amount of small intestinal peristalsis is insufficient to separate and / or expel 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 anastomotic devices of the present specification allows them to automatically reattach and correct orientation in the event of separation. Because prior art devices require two separate devices to form anastomosis, these devices are at risk of spontaneous separation at the distances shown in boxes 3925 and 3926, and ultimately removal without reattachment.

[0316] Case 3: Device with three coil loops on each side of the anastomosis

[0317] Fig.39E is a diagram showing the relationship between the distance between coil loops and the extrusion pressure provided by a stapling device according to an embodiment of the present specification, the stapling device having three coil loops on each side of the stapling to be formed. In other words, Fig.39EEach device shown includes a total of three pairs of coil loops, each pair of loops including a single coil on each side of the anastomosis to be formed, for a total of 6 loops. Curves 3930, 3931 and 3932 show the relationship between the distance between the coil loops and the pressure for a device having 3 pairs of coil loops, an inner 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 peristaltic properties of the gastrointestinal tract produce a maximum stomach pressure 3933 of about 7.25 psi (0.05 MPa) and a maximum small intestinal pressure 3934 of about 1.88 psi (0.013 MPa). As shown in FIG. Fig.39E As shown, the pressure (P) formed by the anastomotic device increases as the distance (d) between the coil loops decreases. In addition, the pressure formed increases as the magnet width increases. For example, curve 3932 shows that the device including the 3.0mm magnet of width has about 7.25psi (0.05MPa) pressure at about 0.65cm distance, and by comparison, curve 3930 shows that the device including the 2.0mm magnet of width has about 3.63psi (0.025MPa) pressure at the same distance. In order to form gastric anastomosis, the device including the 2mm to 3mm magnet needs to reach a distance of not more than 4mm to 7mm between the loops and therefore between the magnets, so that the gastric pressure can not separate the loops. The coil separation can be further prevented from the coil and the self-alignment feature. Fig.39E All devices shown include 2.0 mm, 2.5 mm and 3 mm diameter magnets that cannot be separated by small bowel pressure. The cumulative thickness of the organ wall is assumed to be greater than 10 mm.

[0318] As the distance between the coil loops increases, the pressure developed 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 is at risk of separation. Once each curve 3930, 3931, 3932 is below the assumed maximum gastric pressure 3933, each gastric anastomosis is at risk of separation. That is, due to gastric pressure, the gastric anastomosis is at risk of separation. Fig.39E Each gastric anastomosis formed by the device shown is at risk of separation at a distance ranging from at least 0.65 cm to 1 cm. The device does not experience separation risk due to small intestinal pressure. Therefore, assuming a magnet diameter of 3.0 mm and a spacing of less than 6.5 mm, gastric peristalsis will not be sufficient to separate the magnet and / or expel it. Assuming a magnet diameter of 3.0 mm and a normal amount of small intestinal peristalsis is insufficient to separate the magnet and / or expel it. Therefore, for Fig.39EFor all devices shown, increasing the number of coil pairs from 1 to 3 further reduces the risk of anastomosis separation at greater distances. As previously described, the single device structure of the anastomotic devices of the present specification allows them to automatically reattach and correct orientation in the event of separation. Because prior art devices require two separate devices to form anastomosis, these devices are at risk of spontaneous separation at the distance shown in box 3935, and ultimately removal without reattachment.

[0319] Case 4: Magnet with 2.0 mm diameter and device with varying number of coil loops on each side of the anastomosis Place

[0320] Fig.39F and 39G are graphs showing the relationship between compression pressure and coil inter-loop distance and the relationship between force and coil inter-loop distance, respectively, provided by a stapling device having a 2.0 mm diameter magnet and a varying number of coil loops on each side of the stapling to be formed, according to an embodiment of the present specification. Fig.39F and 39G As shown, pressure (P) and force (F) increase as the distance (d) between coil loops decreases. Curves 3940 and 3950 represent a device having a width or diameter of 2.0, an inner 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 having a width or diameter of 2.0, an inner 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 having a width or diameter of 2.0, an inner 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 having a width or diameter of 2.0, an inner 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 can increase the pressure and force generated by the device at the same distance. For example, the device with four coil loop pairs shown in curves 3943, 3953 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 the device with only one pair of coil loops shown in curves 3940, 3950 generates a pressure of about 2.9 psi (0.02 MPa) and a force of about 4 N at the same distance. See Fig.39F Once the pressure generated by the device drops below the assumed maximum gastric pressure 3944, a passage occurs when there is a distance of 0.8 to 1.0 cm between the coil loops (as shown in box 3946). Fig.39FSpontaneous separation of gastric anastomoses formed by all devices shown. Devices with only 1 pair of coil loops are susceptible to small bowel anastomotic separation, as shown by curve 3940 dropping below the assumed maximum small bowel pressure 3945. Therefore, assuming a 4 pair coil device includes magnets with a diameter of 2.0 mm and less than 8 mm apart, gastric peristalsis will not be sufficient to separate and / or expel the magnets. Assuming a 4 pair coil device includes magnets with a diameter of 2.0 mm, the amount of normal small bowel peristalsis will not be sufficient to separate and / or expel the magnets.

[0321] Case 5: Magnet with 2.5 mm diameter and device with varying number of coil loops on each side of the anastomosis Place

[0322] Fig.39H and 39I are graphs showing the relationship between compression pressure and coil inter-loop distance and between force and coil inter-loop distance, respectively, provided by a stapling device having a 2.5 mm diameter magnet and a varying number of coil loops on each side of the stapling to be formed, according to an embodiment of the present specification. Fig.39H and 39I As shown, pressure (P) and force (F) increase as the distance (d) between coil loops decreases. Curves 3960 and 3970 represent a device having a width or diameter of 2.5, an inner 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 having a width or diameter of 2.5, an inner 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 having a width or diameter of 2.5, an inner 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 having a width or diameter of 2.5, an inner 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 can increase the pressure and force generated by the device at the same distance. For example, the device with four coil loop pairs shown in 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 the device with only one pair of coil loops shown in 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. See Fig.39H Once the pressure generated by the device drops below the assumed maximum gastric pressure 3964, a passage occurs when there is a distance of 0.8 to 1.0 cm between the coil loops (as shown in box 3966). Fig.39HSpontaneous separation of gastric anastomoses formed by all devices shown. Devices with only 1 pair of coil loops are susceptible to small bowel anastomotic separation, as shown by curve 3960 dropping below the assumed maximum small bowel pressure 3965. Therefore, assuming a 4 pair coil device includes magnets with a diameter of 2.5 mm and less than 8 mm apart, gastric peristalsis will not be sufficient to allow the magnets to separate and / or expel them. Assuming a 4 pair coil device includes magnets with a diameter of 2.5 mm, the normal amount of small bowel peristalsis is insufficient to allow the magnets to separate and / or expel them.

[0323] Case 6: Magnet with 3.0 mm diameter and device with varying number of coil loops on each side of the anastomosis Place

[0324] Figure 39K and 39J are graphs showing the relationship between compression pressure and coil inter-loop distance and between force and coil inter-loop distance, respectively, provided by a stapling device having a 3.0 mm diameter magnet and a varying number of coil loops on each side of the stapling to be formed, according to an embodiment of the present specification. Figure 39K and 39J As shown, pressure (P) and force (F) increase as the distance (d) between coil loops decreases. Curves 3980 and 3990 represent a device having a width or diameter of 3.0, an inner 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 having a width or diameter of 3.0, an inner 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 having a width or diameter of 3.0, an inner 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 having a width or diameter of 3.0, an inner 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 can increase the pressure and force generated by the device at the same distance. For example, the device with four coil loop pairs shown in curves 3983, 3993 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 the device with only one pair of coil loops shown in curves 3980, 3990 generates a pressure of about 2.9 psi (0.02 MPa) and a force of about 4 N at the same distance. See Figure 39K Once the pressure generated by the device drops below the assumed maximum gastric pressure 3984, a passage occurs when there is a distance of 0.84 to 1.0 cm between the coil loops (as shown in box 3986). Figure 39KSpontaneous separation of gastric anastomosis formed by all devices shown. None of the devices suffered small bowel anastomosis separation as none of the curves dropped below the assumed maximum small bowel pressure of 3985. Therefore, assuming that the 4-pair coil device includes magnets with a diameter of 3.0 mm and are spaced less than 8.4 mm apart, gastric peristalsis will not be sufficient to separate and / or expel the magnets. Assuming that the 4-pair coil device includes magnets with a diameter of 3.0 mm, the amount of normal small bowel peristalsis will not be sufficient to separate and / or expel the magnets.

[0325] Fig.40A An exemplary device 4000 for forming anastomosis in a pre-crimping configuration according to an embodiment of the present specification is shown. The device 4000 includes a shape memory alloy (SMA) wire 4002 having a plurality of magnets 4004 and spacers 4006 coaxially and alternately positioned around the wire 4002. In one embodiment, the wire 4002 includes nitinol. In one embodiment, the spacer 4006 includes 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, the length of the device 4000 for forming anastomosis is 440 to 460 mm in the pre-crimping configuration. 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 nut and the device 4000 is connected to the delivery device via a threaded mechanism.

[0326] Fig.40B and 40C Shown in a curled configuration Fig.40A Device 4000 for forming anastomosis. Fig.40A , 40B and 40C. After deployment, and when exposed to body temperature, the SMA wire 4002 curls to allow the device 4000 to Fig.40A The uncurled structure shown moves to Fig.40B and 40C The curled 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 connecting to a delivery device. In one embodiment, the length of the anastomotic device 4000 in the curled state is 22 to 23 mm.

[0327] Fig.40D A delivery device 4010 is shown according to an embodiment of the present specification, which is used to deliver a desired location in the body. Fig.40A , 40B40C and 40C. The delivery device 4010 includes: a handle 4016 including a first proximal portion 4017 and a second distal portion 4019 having a port 4012; a body 4014 including an outer sheath 4013 coaxially positioned around an inner shaft 4015; and a distal tip 4018; the delivery device is used to deliver the SMA anastomotic coil 4000 to a 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 allows the inner shaft 4015 to move in and out of the outer sheath 4015 at the distal end of the delivery device body 4014. During delivery, a warm liquid can be introduced through the port 4012, which warm liquid helps to transform the anastomotic device 4000 from its straight pre-deployment configuration to its curled post-deployment configuration when contacting the shape memory alloy of the anastomotic device 4000. Fig.40E , 40F and 40G show the embodiment according to this specification Fig.40D The delivery device 4010 is shown connected to Fig.40B and 40C In some embodiments, the distal end 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 threaded spindle, the device connector 4008 comprises a nut, and the delivery connector 4020 and the device connector 4008 together comprise a threaded mechanism. The delivery device 4010 is connected to the device 4000 for forming an anastomosis. In one embodiment, before deployment, the delivery device 4010 is in a state of being in a state of being connected to the anastomotic device 4000. Fig.40A The anastomotic device 4000 shown in a straight configuration is positioned within an outer sheath 4013 of a delivery device body 4014, which helps constrain the anastomotic device 4000 and prevent it from curling prior to delivery to a desired location in the patient's body. The body 4014 is long and tubular and is inserted into the body through a channel of an endoscope so that the distal tip 4018 connected to the anastomotic device 4000 (in a non-curled shape) protrudes beyond the distal end of the endoscope. See Fig.40D , 40E , 40F and 40G, once the delivery device 4010 is positioned at the desired location in the human body, the handle 4016 is actuated to extrude the anastomotic device 4000 out of the outer sheath 4013 and disengage the delivery connector 4020 from the device connector 4008, allowing the anastomotic device 4000 to be deployed and changed to its curled structure.

[0328] Figure 40H4 is a flowchart that lists the steps involved in a method for deploying an anastomotic device using a delivery device according to an embodiment of the present specification. In step 4021, an endoscope is inserted into the patient's body, and the distal end of the endoscope is positioned near the desired anastomotic location. In step 4022, an anastomotic device having a device connector at its proximal end and in a straight pre-deployment configuration is connected to the delivery device via a delivery connector at the distal end of the delivery device, and is retracted into the tubular sheath of the delivery device using a delivery device handle. In step 4023, the distal end of the delivery device with the anastomotic device attached is inserted into the instrument channel of the endoscope. Subsequently, in step 4024, the user manipulates the handle of the delivery device to advance the delivery device beyond the distal end of the endoscope and extend the anastomotic device beyond the tubular sheath to position the anastomotic device near the desired anastomotic location. Optionally, in step 4025, the user injects a warm fluid through a port on the delivery device handle or provides an electric current to the device to heat the device, assisting the anastomotic device in transforming from a straight pre-deployment configuration to a curled post-deployment configuration. At step 4026, the user actuates the handle to disengage the delivery connector from the device connector, allowing the anastomotic device to separate from the delivery device, curl into its post-deployment configuration, and form the anastomosis. At step 4027, the delivery device and endoscope are removed from the patient's body.

[0329] The above examples are merely illustrative examples of many applications of the present specification system. Although only a few embodiments of the present invention are described herein, it should be understood that the present invention can be implemented in many other specific forms without departing from the spirit or scope of the present invention. Therefore, the examples and embodiments of the present invention are considered to be exemplary rather than restrictive, and the present invention can be changed within the scope of the appended claims.

Claims

1. A catheter for delivering a device for performing anastomosis on body tissue, the catheter include: elongated inner cavity; anastomotic device adapted to be positioned in the elongated lumen, wherein the anastomotic device comprises: a wire, wherein the wire is in a generally straight form when within the elongated lumen, wherein the wire forms a coil when outside the elongated lumen, the coil having at least a first loop and a second loop, and wherein the wire is adapted to transform from the generally straight form into the coil when exposed to a temperature greater than a threshold value; and a plurality of magnets positioned on the wire, wherein each of the plurality of magnets has an inner cavity through which the wire extends, wherein, in each of the first loop and the second loop, a portion of adjacent ones of the plurality of magnets are configured not to be attached to each other, wherein a portion of the plurality of magnets in the first loop is configured to attract a portion of the plurality of magnets in the second loop, and wherein, when the wire is converted into a coil, each of the plurality of magnets is aligned along a same plane; The catheter is adapted to be positioned in a body cavity near the body tissue, and the anastomosis device is adapted to be released from the catheter so that when it is transformed from a substantially straight form to a coil, the body tissue is caught between the first loop and the second loop, thereby being squeezed and achieving anastomosis.

2. The catheter of claim 1, wherein the anastomotic device further comprises a non-ferromagnetic spacer positioned between adjacent magnets of the plurality of magnets.

3. A catheter as described in claim 2, wherein the non-ferromagnetic spacers each have a length sufficient to keep the attractive force between opposite poles of adjacent magnets below the coil bending force.

4. The catheter according to claim 1, in, In the second state, the maximum cross-sectional diameter of the first ring and the second ring is 5 mm to 50 mm.

5. The catheter of claim 1, wherein the plurality of magnets each have a maximum cross-sectional length or diameter of 0.2 mm to 7 mm and a tensile force of 0.01 lb to 4 lb.

6. The catheter according to claim 1, in, In the first loop and in the second loop, at least 50% of adjacent magnets of the plurality of magnets are arranged with the same poles facing each other, thereby forming a repulsive force between the adjacent magnets in the first loop and a repulsive force between the adjacent magnets in the second loop of the coil. The catheter of claim 1 , wherein at least one end of a wire is connected to the catheter.

8. The catheter of claim 1, wherein the wire comprises a shape memory alloy.

9. The catheter of claim 1, wherein the threshold value is 20 degrees Celsius.

10. The catheter of claim 1, wherein the coil has at least one loop proximal to a first loop and at least one loop distal to a second loop.

11. The catheter of claim 1, wherein 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, or titanium.

12. The catheter of claim 1, wherein at least one end of the wire is in electrical communication with a current source, and in, The current source is configured to deliver an amount of current sufficient to heat the stapling device by passing current through the stapling device, thereby facilitating the transition from the first state to the second state.

13. The catheter of claim 1, wherein the wire diameter is 0.1 mm to 10 mm and the wire length is 1 cm to 250 cm.

14. The catheter of claim 1, wherein the wire diameter is 0.1 mm to 6 mm and has a maximum strain of less than 10% in the first state, and in, In the second state, the maximum cross-sectional dimensions of the first ring and the second ring are 5 mm to 60 mm.

15. The catheter of claim 1, wherein the adjacent body tissue includes a gallbladder and a duodenum, and wherein a maximum diameter of the first loop and the second loop is less than or equal to 30 mm.

16. The catheter of claim 1, wherein the adjacent body tissue includes pancreatic tissue and the maximum diameter of the first loop and the second loop is greater than or equal to 5 mm.

17. The catheter of claim 1, wherein the adjacent body tissue includes biliary tissue and the maximum diameter of the first loop and the second loop is greater than or equal to 5 mm.

18. The catheter of claim 1, wherein the diameter of the wire is less than 0.5 mm, and wherein the maximum cross-sectional dimension of the first loop and the second loop is less than or equal to 15 mm.

19. The catheter of claim 1, wherein the diameter of the wire is 0.5 mm to 1.0 mm, and wherein the maximum cross-sectional dimension of the first loop and the second loop is 10 mm to 25 mm.

20. The catheter of claim 1, wherein the diameter of the wire is greater than 1 mm, and wherein the largest cross-sectional dimension of the first loop and the second loop is greater than 20 mm.

21. The catheter of claim 1, wherein the first loop and the second loop have at least one of a circular shape and a polygonal shape.

22. The catheter of claim 1, wherein a portion of adjacent magnets of the plurality of magnets on a same loop are configured to repel each other.

23. The catheter of claim 1, wherein a squeezing force generated by the body tissue being caught between the first loop and the second loop and thereby squeezed is greater than or equal to 0.3 psi at two or more points on opposite sides of at least one of the first loop and the second loop.

24. The catheter of claim 1, wherein the first loop and the second loop have a star shape with four or more points.

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