Magnetic compression stapling device with multi-piece internal vertebral support structure

Abstract

A magnetic compression anastomosis device includes: a first multi-piece internal vertebral support structure including a first set of magnets attached to an outwardly facing side of the first multi-piece internal vertebral support structure; and a second multi-piece internal vertebral support structure, the second multi-piece internal vertebral support structure comprising a second set of magnets attached to an outwardly facing side of the second multi-piece internal vertebral support structure, wherein the first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together in a sandwich configuration wherein an inwardly facing side of the first multi-piece internal vertebral support structure faces an inwardly facing side of the second multi-piece internal vertebral support structure, and the magnet is positioned on the outward-facing side surface of the magnetic compression anastomosis device.

Description

[0001] Cross - Reference to Related Applications

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 400,904, entitled "SUPPORT FOR MAGNETIC SEGMENTS OF A MAGNETIC ANASTOMOSIS DEVICE", filed on August 25, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0003] The present invention relates to deployable magnetic compression devices and, more particularly, to systems, devices, and methods for delivering, deploying, and positioning magnetic compression devices at a desired site to improve the accuracy of anastomosis formation between tissues, organs, etc. Background Art

[0004] Bypasses in the gastrointestinal (GI), cardiovascular, or urological systems are typically formed by cutting holes in tissue at two locations and joining the holes with sutures or staples. Bypasses are typically placed to direct fluid (e.g., blood, nutrients) between healthier parts of the system while bypassing diseased or malfunctioning tissue. This process is typically invasive and subjects the patient to risks such as bleeding, infection, pain, and adverse reactions to anesthesia. Additionally, bypasses created with sutures or staples can become complicated due to postoperative leaks and adhesions. Leaks can lead to infection or sepsis, while adhesions can result in complications such as bowel torsion and obstruction. Although traditional bypass surgeries can be done endoscopically, laparoscopically, or robotically, joining the holes cut in the tissue can be time - consuming. Moreover, such surgeries require specialized techniques and devices that are not available at many surgical facilities.

[0005] As an alternative to sutures or staples, surgeons can use mechanical couplers or magnets to create a compression anastomosis between tissues. For example, a compression coupler or a pair of magnets can be delivered to the tissues to be joined. Due to the strong compression, the tissue captured between the coupler or magnets has its blood supply cut off. Under these conditions, the tissue becomes necrotic and degenerates while new tissue grows around the compression point, e.g., at the edges of the coupler. Over time, the coupler can be removed, leaving a healed anastomosis between the tissues.

[0006] Nevertheless, the difficulty of placing the magnets or couplers limits the locations where compression anastomosis can be used. In most cases, the magnets or couplers must be delivered as two separate components, requiring an open surgical area or a bulky delivery device. For example, existing magnetic compression devices are limited to structures small enough to be deployed using a delivery catheter (e.g., an endoscopic instrument channel or a laparoscopic port). When using these smaller structures, the resulting anastomosis is smaller and suffers from short-term patency. In addition, the placement of the magnets or couplers may be imprecise, which can lead to the formation of anastomosis at an undesired or inaccurate location.

[0007] Accordingly, there remains a clinical need for reliable devices and minimally invasive procedures that facilitate the formation of compression anastomosis between human tissues. SUMMARY OF THE INVENTION

[0008] During the deployment of a self-forming magnetic array, the control of individual magnetic elements is critical. Limiting the degrees of freedom to a specific set of parameters provides durability as well as improved geometric control. When joining two separate magnets, it is also important that the geometric alignment results in a compression zone with a high enough pressure to close the fluid exchange with the tissue in the inner perimeter of the geometry generated by the self-forming array.

[0009] Embodiments of the present invention utilize independent magnets connected by a multi-piece vertebral design. Existing innovations utilize a single formed alloy piece to provide support. The present invention utilizes separate flexible segments connected to a flexing armature, a vertebral sleeve, and a "roller" or an integrated "rolling node" to limit the degrees of freedom during forming and increase durability.

[0010] During the coupling of two magnetic arrays, the ability to sense the mating array is more easily achieved using a single magnetic pole face. Embodiments of the present invention provide an internal framework that pushes the same pole faces together.

[0011] More specifically, according to one embodiment of the present invention, a magnetic compression anastomosis device includes: a first multi-piece internal vertebral support structure including a first set of magnets attached to an outward-facing side of the first multi-piece internal vertebral support structure; and a second multi-piece internal vertebral support structure including a second set of magnets attached to an outward-facing side of the second multi-piece internal vertebral support structure, wherein the first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together in a sandwich configuration, wherein an inward-facing side of the first multi-piece internal vertebral support structure faces an inward-facing side of the second multi-piece internal vertebral support structure, and the magnets are located on the outward-facing sides of the magnetic compression anastomosis device.

[0012] In various alternative embodiments, the first and second multi-piece internal vertebral support structures can be attached together, for example, by welding, bonding, swaging, or stamping. Each magnet can have a north pole and a south pole, and all north poles or all south poles can face outward such that both sides of the magnetic compression anastomosis device have magnets of all the same polarity. The magnets can be attached to the multi-piece internal vertebral support structure, for example, using adhesives, mechanical fasteners, snaps, or interlocking elements. The device can also include at least one flexible element that biases the multi-piece internal vertebral support structure toward an assembled configuration. The assembled configuration can be circular or polygonal. Each of the first and second multi-piece internal vertebral support structures can include a plurality of interconnected internal vertebral pieces having male ends opposite female ends, where the ends of opposite genders are configured to interlock and engage the pieces together. Such interconnected individual internal vertebral pieces can be connected by bolts, rivets, or fasteners. In general, the connection between the interconnected individual internal vertebral pieces is configured to allow rotation along an axis while also restricting torsional movement. The multi-piece internal vertebral support structure can be formed from a metal alloy, a polymer, and / or a composite material.

[0013] Additional embodiments can be disclosed and claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Those skilled in the art will more fully appreciate the advantages of the various embodiments of the present invention from the "DETAILED DESCRIPTION" discussed below with reference to the following immediately summarized drawings.

[0015] Figure 1 Shown is a magnet assembly delivered through an endoscopic instrument channel such that the individual magnets self-assemble into a larger magnetic structure, an octagon, in this particular case.

[0016] Figure 2A Shown is a magnet assembly that has been delivered and deployed to adjacent tissue.

[0017] Figure 2B Shown are two magnet assemblies coupled together by magnetic attraction to capture intervening tissue. In some cases, an endoscope can be used to cut through the external tissue.

[0018] Figure 3 Shown are several potential anatomical targets for anastomosis formation: arrow A is from the stomach to the small intestine, arrow B is from the small intestine to the large intestine, arrow C is from the small intestine to the small intestine, arrow D is from the large intestine to the large intestine, and arrow E is from the stomach to the large intestine.

[0019] Figure 4A Shown is one embodiment of the delivery using two endoscopes (a colonoscope and an enteroscope or gastroscope) to deliver the magnet assembly.

[0020] Figure 4BAnother embodiment is shown using two upper endoscopes that share each oral entry for delivering the magnet assembly.

[0021] Figure 5 Another embodiment of the delivery is shown using a single endoscope to sequentially deliver the magnet assembly.

[0022] Figure 6 Another example is shown using an endoscopic ultrasound-guided needle delivery to deliver one magnet assembly into lumen #1 and then deploy a second magnet assembly into lumen #2.

[0023] Figure 7 An initial anastomosis is shown being formed to serve as a conduit for deeper endoscope delivery in order to form subsequent multiple anastomoses.

[0024] Figure 8 A laparoscopic magnet device is shown being delivered into a lumen (in this example, the stomach).

[0025] Figure 9A An endoscopic ultrasound-guided needle for delivering a magnet assembly into the gallbladder is shown, and the magnet assembly is then coupled to a second magnet assembly in the stomach or duodenum as Figure 9B shown.

[0026] Figure 10 The deployment of a stent between the gallbladder and the stomach or duodenum is shown.

[0027] Figure 11 Another embodiment of a magnet assembly within the gallbladder is shown, which is a balloon filled with fluid, gas, or magnetic material. The balloon is tethered to the endoscope and initially delivered through an endoscopic ultrasound-guided needle.

[0028] Figure 12 An endoscopic ultrasound-guided needle for delivering a magnet assembly into the bile duct is shown.

[0029] Figure 13 A magnet assembly delivered into the bile duct through an endoscopic retrograde cholangiography technique is shown.

[0030] Figure 14 The coupling of a magnet assembly within the bile duct to a second magnet assembly deployed in the stomach (A) or duodenum (B) is shown.

[0031] Figure 15 Another embodiment of a bile duct magnetic anastomosis is shown, where an articulated magnetic bile duct stent swings back onto itself by magnetic attraction to form an anastomosis between the bile duct and the duodenum.

[0032] Figure 16Shows a magnetic stent that can be delivered into the pancreatic duct. The stent can be coupled with magnets in the stomach (A) or duodenum (B) to create a drainage anastomosis of the pancreatic duct.

[0033] Figure 17 Shows the delivery of a magnetic component into the peripancreatic collection (dashed structure) using an endoscopic ultrasound-guided needle / catheter, which is then coupled with a second magnetic component deployed in the stomach.

[0034] Figure 18 Shows different targets for anastomosis between the urinary and gastrointestinal systems: renal calyx (A), ureter (B), and bladder (C).

[0035] Figure 19 Shows magnet components in adjacent blood vessels to couple and form a vascular anastomosis.

[0036] Figure 20 Shows magnet components in different parts of the respiratory system to form an anastomosis between adjacent bronchioles.

[0037] Figure 21 Shows an external magnet component for creating a surgical stoma for fecal drainage and an internal magnet component within the gastrointestinal tract.

[0038] Figure 22 Depicts an exploded view of a multi-piece vertebra of a self-assembling magnetic compression anastomosis device according to certain embodiments.

[0039] Figure 23 Is Figure 22 An enlarged view of the various components shown, and also shows an example of a flexible element according to certain embodiments.

[0040] Figure 24 Shows an alternative example of a flexible element according to certain embodiments.

[0041] Figure 25 Shows the profiles of various geometries of magnetic segments according to certain embodiments.

[0042] Figure 26 Shows an example of a roller in the form of a torsion spring according to certain embodiments.

[0043] Figure 27 Depicts parts of two multi-piece internal vertebral support structures that can be used to form a sandwich structure according to certain embodiments.

[0044] Figure 28 Shows a left vertebral support structure that supports a first set of magnets and a right vertebral support structure that supports a second set of magnets according to certain embodiments.

[0045] Figure 29Shows a magnetic compression anastomosis device according to certain embodiments, in which left and right multi-piece internal vertebral support structures are interconnected.

[0046] It should be noted that the foregoing drawings and the elements depicted therein are not necessarily drawn to scale or any scale. Unless the context otherwise indicates, the same elements are denoted by the same numbers. The drawings are for illustrative purposes primarily and are not intended to limit the scope of the inventive subject matter described herein. Detailed Description

[0047] Exemplary embodiments provide improved devices and techniques for minimally invasive formation of anastomoses within a body such as the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatment of chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment for diseases such as cancer (e.g., gastric or colon cancer).

[0048] The system generally includes an access device configured to be disposed within a patient's hollow body and to facilitate formation of an anastomosis at a target site (desired anatomical location) within the hollow body for forming an anastomosis between a first portion of tissue of the hollow body at the target site and a second portion of tissue of an adjacent hollow body (e.g., between the gallbladder and the stomach, between the stomach and the duodenum, between the ileum and the colon, etc.). The access device is configured to provide access to the first portion of tissue of the hollow body and to further deliver and position a first implantable magnetic anastomosis device. A second implantable magnetic anastomosis device is delivered to the adjacent hollow body, for example, using the same access device or a second access device. The first implantable magnetic anastomosis device and the second implantable magnetic anastomosis device are configured to magnetically attract each other through a defined tissue region of the combined thickness of the tissue wall at the target site and to apply a compressive force over the defined region to form an anastomosis.

[0049] The systems, devices, and methods described herein include, but are not limited to, various access devices for accessing a patient's hollow body (such as the gallbladder) and fixed positioning of the access device for subsequent placement of one of a pair of magnetic anastomosis compression devices. The systems, devices, and methods described herein also include various delivery devices for delivering at least one of the pair of magnetic anastomosis compression devices to a target site, where, in some cases, a delivery device consistent with the present disclosure may assist in deploying at least one of the pair of magnetic anastomosis compression devices and subsequently fixing to the target site and / or coupling the pair of magnetic anastomosis compression devices to each other. The systems, devices, and methods described herein include various embodiments of magnetic anastomosis compression devices and various designs for generally transitioning from a compact delivery configuration to a larger deployed configuration through a self-assembly design.

[0050] More specifically, an exemplary embodiment provides a system including a delivery device for introducing and delivering a pair of magnetic components between adjacent organs via minimally invasive techniques to bridge the walls of the tissue of each organ together to form a passageway (i.e., an anastomosis) therebetween. The delivery device is particularly useful in delivering a pair of magnetic components to a target site within the gastrointestinal tract to form an anastomosis between the stomach and the gallbladder wall to provide adequate drainage from the gallbladder in the event of an obstruction (due to disease or other health-related issues).

[0051] Accordingly, exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses within the body, such as within the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatment of chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment for diseases such as cancer, such as gastric or colon cancer.

[0052] For example, in endoscopic surgery, a single endoscopic delivery of a self-assembling magnetic device can be used. Exemplary magnetic anastomosis devices can be delivered endoscopically such that individual magnet segments self-assemble into a larger magnetic structure. When used in conjunction with the techniques described herein, if the device is deployed as a complete assembly, the device allows for the delivery of a larger magnetic structure via a small delivery catheter (such as within a standard endoscope) than might otherwise be possible. The larger magnet structure in turn allows for the creation of a more robust and larger anastomosis and the achievement of greater surgical success. For example, in some cases, the resulting anastomosis can have an aspect ratio of 1:1 relative to the final size of the assembled magnetic device. However, exemplary embodiments allow for a larger aspect ratio (i.e., a larger anastomosis relative to the size of the magnetic components). In particular, prior art systems and methods that include the use of magnets to form anastomoses are typically limited based on the size of the working channel of the scope or catheter used to deliver such magnets, which in turn limits the resulting size of the anastomosis. However, the magnetic component design of the exemplary embodiments overcomes this limitation. For example, the design of the magnetic components, particularly multiple magnetic segments coupled to each other via a support, allows any number of segments to be included in a single component and thus the resulting anastomosis has a larger size relative to the size of the working channel of the scope. For example, in some embodiments, the resulting anastomosis can include an aspect ratio in the range of 2:1 to 10:1 or greater.

[0053] Magnetic anastomosis devices generally include magnetic segments that can assume a delivery configuration and a deployment configuration. The delivery configuration is generally linear such that the device can be delivered to tissue via a laparoscopic "keyhole" incision or via a natural passageway (e.g., via the esophagus) using an endoscope or similar device. Additionally, the delivery configuration is generally somewhat flexible such that the device can be guided through various curves in the body. Once the device is delivered, the device assumes a deployment configuration of a desired shape and size by automatically transitioning from the delivery configuration to the deployment configuration. The self-transition from the delivery configuration to the deployment configuration is guided by a coupling structure that moves the magnetic segments in a desired manner without intervention. Exemplary self-assembling magnetic anastomosis devices (such as self-closing, self-opening, etc.) are described in U.S. Patent No. 8,870,898, U.S. Patent No. 8,870,899, U.S. Patent No. 9,763,664, and U.S. Patent No. 10,182,821, the entire contents of each of which are incorporated herein by reference.

[0054] During the deployment of a self-forming magnetic array, control of individual magnetic elements is crucial. Limiting the degrees of freedom to a specific set of parameters provides durability as well as improved geometric control. When joining two separate magnets, it is equally important that the geometric alignment produces a compression zone with a pressure high enough to cut off fluid exchange with tissue in the inner perimeter of the geometry created by the self-forming array.

[0055] In certain embodiments, as Figure 22 schematically illustrated, the magnetic compression anastomosis device 100 includes a plurality of magnetic segments 101 (three of the eight magnetic segments 101 of the embodiment are labeled, but it should be noted that the embodiment is not limited to any particular number of magnetic segments). For convenience, the magnetic segments 101 may be referred to herein as vertebrae 101, and each individual magnetic segment 101 may be referred to as a vertebra 101.

[0056] The vertebra 101 is configured to permit movement between a delivery configuration of the device 100, which typically has a substantially linear alignment for assembly within a delivery device such as a catheter, endoscope, laparoscope, trocar, needle, or other delivery device, and a fully assembled configuration of the device 100 (e.g., a circular or polygonal configuration), while restricting one or more undesired degrees of freedom of the vertebrae that could result in incomplete assembly or non-assembly of the device 100, such as twisting, over-rotation, under-rotation, and out-of-plane deflection. Thus, embodiments of the device 100 can be self-assembling devices (e.g., automatically and autonomously transitioning to a fully assembled configuration upon delivery), but embodiments can additionally or alternatively include additional elements to assist or manually place the device 100 in a fully assembled form (e.g., sutures, wires, etc.). For the purposes of this discussion, when in the fully assembled configuration, the plane of the device 100 can be considered to be the plane extending through the centers of the vertebrae. The vertebra 1010 includes a proximal vertebra and a distal vertebra that are magnetically coupled to each other in the assembled configuration to form a circular or polygonal arrangement.

[0057] As discussed in more detail below, in some embodiments, each vertebra 101 can be a multi-piece vertebra including a vertebra skin 102 that fully or partially encapsulates one or more magnets 103 and other components discussed herein. The device 100 can be configured with different magnetic polarity configurations, e.g., all vertebrae 101 having the same magnetic polarity, vertebrae 101 having alternating magnetic polarities, vertebrae 101 having alternating magnetic polarity pairs, vertebrae 101, etc. The present invention is not limited to any particular magnetic polarity configuration.

[0058] Each pair of adjacent interconnected vertebrae 101 is rotatably connected by a cylindrical roller 104. For the purposes of this discussion, the cylindrical roller is typically a hollow cylinder (e.g., tubular), but can be a solid cylinder in some embodiments. The roller 104 can be used to provide radial constraint and limit degrees of freedom, thereby strengthening the assembly from a torsional perspective. The roller 104 can be constructed of a metal alloy, polymer, and / or composite material. The roller 104 is preferably configured to permit rotation of the vertebrae 101 in the plane of the device, but otherwise limit other degrees of freedom. The roller 104 can include features such as protrusions or recesses to help secure the roller 104 between the two vertebrae 101 and / or control the amount of rotation that can occur between the two vertebrae 101, e.g., to provide radial constraint and limit degrees of freedom, thereby strengthening the assembly from a torsional perspective. The roller 104 can be constructed of any suitable material, such as a metal alloy, polymer, and / or composite material. The roller 104 can be a separate component adapted to fit between two or more magnets 103. Each magnet 103 can include a notch at each end that is adapted to mate with the roller, thereby allowing movement in one plane while restricting movement in the opposing 90-degree plane.

[0059] Each pair of adjacent interconnected vertebrae 101 generally also includes a flexible element 106 (an example of which is shown in Figure 23 ) that helps move the vertebrae 101 from the delivery configuration to the assembled configuration. For example, the flexible element 106 can operate as a spring (e.g., the flexible element can include a spring or can be formed from a shape memory material), and can be biased towards the assembled configuration such that the vertebrae 101 are biased towards the assembled configuration when in the delivery device 100. The flexible element 106 can be constructed of any suitable material, such as a metal alloy, a polymer, and / or a composite material, particularly a shape memory material. In various embodiments, the flexible segment is positioned between two vertebra skins on the outer periphery of the array. However, it should be noted that the flexible segment can also be positioned on the inner perimeter of the array. The flexible segment is used to strengthen the array and limit degrees of freedom. The flexible member can also be used to help the array deploy into the appropriate assembled geometry.

[0060] The vertebra skin 102 can be formed of a suitable material such as a metal alloy, a polymer, and / or a composite material, and specifically can be formed of or include a shape memory material. The vertebra skin 102 encapsulates the magnet 103 and helps secure the roller 104 and the flexible element 106 within the device 100, thereby forming a protective layer while also limiting degrees of freedom. The vertebra skin 102 can be secured to the magnet 103 with or without additional fasteners such as screws, pins, adhesives, interlocking elements, etc. Thus, for example, in the case where the magnet 103, the roller 104, and the flexible element 106 are positioned for assembly, the vertebra skin 102 can be mounted over the magnet 103, the roller 104, and the flexible element 106 in order to encapsulate the components. As shown, the vertebra skin 102 can incorporate male nodes 108 and female nodes 110 at opposite ends of the vertebra that are capable of interacting with corresponding gender nodes on another vertebra. The male nodes 108 of one segment engage or mate with the female nodes 110 of another segment. The combined nodes support movement in one plane while limiting other degrees of freedom. The male nodes 108 can help secure the roller 104 and / or the flexible element 106 within the device 100. The combined nodes can include stops to limit additional degrees of freedom, e.g., to prevent "backward bending" or excessive "forward bending" of the array, as shown at the viewing point 112. The stops can provide interference of the vertebrae while allowing a defined amount of rotation about the axis of interaction of the male and female nodes.

[0061] Figure 23 is Figure 22An enlarged view of the various components shown, and also showing an example of the flexible element 106, in which the flexible element 106 is in the form of a rod having a central spring section formed, for example, from a shape memory material. Without limitation, the flexible element 106 can be configured to fit within the channel 114 of the magnet 103 or be fitted in any other configuration (e.g., above or below the roller 104, which may include a flexible element support 105 on which the flexible element 106 rests to provide a fulcrum for the flexible element 106), thereby allowing the flexible element 106 to control the movement of the vertebra 101, such as biasing the vertebra 101 towards the assembled configuration. Embodiments can include one, two, or more flexible elements 106 and associated elements, such as elements 105 and 114, for example, flexible elements 106 placed on both sides of the vertebra 101. The flexible element 106 can be a single device or can include multiple components.

[0062] Figure 24 An alternative example of the flexible element 106 is shown, in which the flexible element 106 includes two U-shaped brackets oriented in opposite directions, which together with the roller 104 and the magnet 103 as shown in the viewing point 116 operate as a biasing spring in a manner similar to the flexible element 106 described and shown above Figure 23 The U-shaped brackets are placed at each end of the magnetic segment. The U-shaped brackets hold the roller 104 in place while allowing rotation in one plane but restricting out-of-plane movement. The U-shaped brackets can be made of any suitable material, such as metal alloys, polymers, and / or composite materials, and in particular can be formed from or include a shape memory material. The U-shaped brackets allow movement in the plane while restricting torsional movement and movement in a plane at 90 degrees relative. The roller and the U-shaped brackets can be directly fitted onto the magnetic segment and within the vertebral skin. For example, the U-shaped brackets can be fitted through the roller 104 and fixed by the roller 104, as shown in the viewing point 116, and extend along the length of the magnetic segment, for example, extend in the channel 114. The roller 104 can include a flexible element support to fix the U-shaped brackets in a position that allows biasing towards the assembled configuration. By interlocking the roller 104 with the magnet 103, the roller 104 and the U-shaped brackets 106 are used to provide structure and shape to the array, while also strengthening and preventing torsional movement in the array. This allows for more control over the final placement of the magnetic compression anastomosis device and prevents the formation of undesirable geometries.

[0063] Various profiles of the various geometries of the magnetic array are possible for the vertebra 101 of the present invention, as Figure 25As shown. For example, the vertebral skin 102 may include smooth and / or patterned features and may be configured to have different external geometries to achieve different anastomosis objectives. For example, geometry (a) has concave sides, geometry (b) has notched convex sides, geometry (c) has pointed lateral protrusions that may assist in cutting tissue, and geometry (d) has flat sides that may compress and necrose a larger area of tissue. The vertebra 101 may include other features, such as various types of protrusions or depressions, for example to assist in fixing the device 100 to tissue. All vertebrae may use the same geometry, or different vertebrae may use different geometries.

[0064] It should be noted that although in the above embodiment the flexible element 106 is encapsulated under the vertebral skin, alternative embodiments may place the flexible element 106 on the outer side of the vertebral skin.

[0065] It should be noted that although two example flexible elements 106 are shown and described herein, the present invention is not limited to these or any particular flexible element. For example, the flexible element may include a helical spring. In some embodiments, a spring (e.g., a helical spring or a torsion spring) may act as both a roller and a flexible element, for example, as Figure 26 schematically depicted.

[0066] It should be noted that in certain embodiments, the device 100 may be disposed within a delivery device such as a catheter, an endoscope, a laparoscope, a trocar, a needle, or other delivery device, and thus the delivery device combined with the device 100 may be considered an embodiment of the present invention.

[0067] Embodiments may also include a method of manufacturing the device 100, such as by providing various components (e.g., magnets, rollers, flexible elements, and vertebral skin), positioning the roller and the flexible element between two magnets and fixing them as needed (e.g., fixing the flexible element within the magnet channels), and placing the vertebral skin over the magnets, rollers, and flexible elements.

[0068] It should be noted that a kit may be provided with magnets, rollers, flexible elements, and different types of vertebral skin having different configurations that may be used for different types of anastomosis procedures, such that different devices 100 may be prepared, for example, according to the amount and type of pressure required for a particular procedure, the location of the procedure, and the size of the anastomosis to be formed.

[0069] Certain alternative embodiments utilize an internal vertebral support structure such that each magnetic segment is substantially formed as a sandwich structure having two external magnets separated and supported by an internal vertebra. The internal vertebra may be formed of one, two, or more pieces. The vertebrae may be interconnected to form a self-assembling magnetic compression anastomosis device and may employ the above reference Figures 22 to 26Elements of said type to limit unwanted degrees of freedom.

[0070] Figure 27 Depicts portions of two multi-piece internal vertebral support structures that can be used to form a sandwich structure according to certain embodiments. As Figure 28 shown, Figure 27 the left vertebral support structure shown can support a first set of magnets, and Figure 27 the right vertebral support structure shown can support a second set of magnets. Importantly, Figure 28 each vertebra shown can support magnets having the same polarity facing outward such that when the two sets of vertebrae are interconnected to form a magnetic compression anastomosis device with an internal support member, as Figure 29 shown, both sides of the resulting magnetic compression anastomosis device can have the same magnetic polarity. In the Figures 28 to 29 example shown, the segments of the magnetic compression anastomosis device have a north polarity on both sides (referred to herein as the north-north segment). Similar magnetic compression anastomosis devices can be formed to have a south segment on both sides (referred to herein as the south-south segment). Among other things, a first magnetic compression anastomosis device with magnets having all north polarity facing outward and a second magnetic compression anastomosis device with magnets having all south polarity facing outward can facilitate the mating of the first and second magnetic compression anastomosis devices because the devices can mate on either side and the devices can attract each other from a greater distance. Of course, the segments can be configured with other polarities, for example, north on the left and south on the right (referred to herein as the north-south segment) or south on the left and north on the right (referred to herein as the south-north segment). Additionally, the magnetic compression anastomosis device can have all the same type of segments (e.g., all north-north segments, all south-south segments, all north-south segments, all south-north segments, etc.), or alternatively, the magnetic compression anastomosis device can have different types of segments, such as alternating north-north segments and south-south segments or other segment arrangements.

[0071] The magnets can be fixed to the vertebrae using, for example, adhesives, mechanical fasteners, clamps, interlocking elements, etc. The magnetic compression anastomosis device can include one or more flexible elements to bias the device toward an assembled configuration, for example, one or more flexible elements coupled between the two internal vertebral support structures.

[0072] In addition, during the coupling of two magnetic arrays, the ability to sense a mating array is more easily achieved using a single magnetic pole face. In various embodiments of the present invention, an internal support is used to press the same pole faces together. The magnetic arrays can be mechanically held to the internal backbone or adhered. The individual internal backbones can be connected by various methods, including but not limited to welding, bonding, swaging, and / or stamping. The individual and / or connected portions of the internal backbone provide an internal framework that resists the stress of the magnetic segments as they are pressed towards their pole faces. Aligning the magnetic poles of the magnetic segments to have all-north and all-south surfaces on the array provides many benefits, such as a greater sensing distance for a relatively-polar magnetic array and allowing many possible orientations of the array during coupling.

[0073] Each internal vertebrae piece can be made of, for example, metal alloy, polymer, and / or composite material. As Figures 27 to 29 shown, the internal vertebrae pieces generally have a similar shape to the magnetic segments, but can be shaped differently from the magnetic segments. Each internal vertebrae piece can have a male end opposite a female end, where the ends of opposite genders are capable of interlocking and connecting the pieces together. Each internal vertebrae piece can also be connected to each other by bolts, rivets, and / or other fasteners, etc. The connection points between the internal vertebrae pieces allow rotation along the axis while also restricting torsional movement. This allows the internal vertebrae pieces to move in a plane and transition from a delivery configuration to a deployed configuration when incorporated into the magnetic segments.

[0074] The internal vertebrae pieces can be mechanically held on the magnetic array or can be adhered. A single internal vertebra can be connected in a variety of ways, such as but not limited to welding, bonding, swaging, and / or stamping. As Figure 7 shown, the magnetic segments are attached to the internal vertebrae pieces, where the magnetic poles face each other on the inside, thus allowing the all-magnetic north pole to face the outside. The mating array has the same orientation, presenting an all-north pole on the outside and an all-south pole on the inside. By presenting an all-magnetic pole on the outside, the array will have a greater sensing distance, and the rotational orientation of the array will not need to be specific. The internal backbone can be used alone or in combination with an external vertebra support to add structure and support while allowing movement with selected degrees of freedom.

[0075] After the magnetic arrays are mated, the internal backbone engages inside the coupling system. As Figure 28As shown, the full magnetic poles of the arrays are opposite, such as two full north and two full south on the inner side of the anastomosis system. These opposite poles use internal vertebrae to mate. This results in two north poles on the outer side and two south poles on the inner side of the anastomosis system. The arrays can also be configured to have two south poles on the outer side of the anastomosis system and two north poles on the inner side. By utilizing full magnetic poles, the sensing distance between the arrays is greater, and when two separate magnets are connected, the geometries are aligned to create a compression zone with a pressure high enough to cut off the fluid exchange with the tissue in the inner perimeter of the geometry created by the self-forming arrays. This results in a more robust and safer anastomosis with a higher success rate.

[0076] It should be noted that self-assembling magnetic anastomosis addresses several historical drawbacks of traditional anastomosis, such as allowing for minimally invasive surgical-quality anastomosis using devices that can reproducibly reassemble into a predetermined shape in vivo with larger magnet structures. The constraints imposed by the described embodiments are designed to allow the devices to consistently self-assemble into the correct shape upon deployment, which greatly reduces the risk of surgical complications due to deformed or prematurely detached devices and also reduces the risks associated with surgical access and ensures that the anastomosis is formed with the correct geometric properties. Overall, this ensures the patency of the anastomosis.

[0077] Thus, as described herein, embodiments include flexible linear magnetic devices that include linked magnetic multipole segments that self-assemble upon extrusion from the end of a deployment channel or lumen to form a rigid multipole polygonal ring magnet (PRM; generally referred to as the "magnetic device"). The self-assembly is guided by the configuration of magnets, rollers, flexible elements, vertebral skin, and a multi-piece internal vertebral support structure that can return to a predetermined shape. Generally, the physical and magnetic structure of the deployed magnetic device is such that when two magnet devices are brought close to each other, there is a rapidly strengthening attractive magnetic interaction that creates a coupling between the magnetic devices. In some examples, the complementary devices must be pre-aligned, however, in other examples, the devices self-align by undergoing a rapid in-plane rotation relative to each other, as discussed in detail below. As described in detail below, a system that includes the magnetic device can include an endoscope with a sensor that allows the endoscope to sense the position of a mating magnetic device or another endoscope that will deploy a mating device.

[0078] When deployed in adjacent tissues (e.g., adjacent organs or different regions of the same organ), the coupled magnetic devices create a compression ring that can be surgically opened or allow an anastomosis to form without further intervention. When the paired devices are left alone, the compressive force against the tissue collapses the vasculature and extrudes the fluid in the tissue, thereby further reducing the distance between the devices and increasing the magnetic attraction. Over time, the coupled devices eventually fully couple and detach, leaving behind a formed anastomosis. This cascade begins when the devices approach the "capture range," whereby their mutual attraction is sufficient to align the devices, capture the intervening tissue, and resist the natural flexibility of the tissue and tissue movement under normal physiological function.

[0079] Generally, the design specifications of the devices depend on the patient and the intended anastomosis. Design specifications can include: the required capture range, the desired effective inner and outer diameters of the deployed polygonal ring (e.g., as defined by the desired anastomosis size and the instrument channel), the thickness of the target tissue, and the inner diameter of the guide channel and the minimum radius of curvature through which the guide channel can bend and the magnet must pass. Once the design specifications are selected, the corresponding magnetic device design can be determined, such as the polygonal side count and length, and the maximum lateral dimension of the flexible linear magnetic structure that will be deployed via the delivery instrument.

[0080] The deployment of device 100 is generally shown in Figure 1 When used in conjunction with the techniques described herein, if the device is deployed as a complete assembly, the device allows for the delivery of a larger magnetic structure via a small delivery catheter (such as in a standard endoscope) than might otherwise be possible. The larger magnet structure in turn allows for the creation of a stronger and larger anastomosis and the achievement of greater surgical success. Because the magnetic devices are generally radiopaque and echogenic, the devices can typically be located using fluoroscopy, direct visualization (transmitted illumination or tissue indentation), and ultrasound (e.g., endoscopic ultrasound). The devices can also be decorated with radiopaque paint or other markers to assist in identifying the polarity of the device during placement. In some embodiments, the device can be located by using sensors (e.g., using reed switches or Hall effect sensors) located near the delivery lumen and capable of sensing the position of the mating device.

[0081] Generally, as Figure 2A shown, magnetic anastomosis surgery involves placing a first magnetic structure and a second magnetic structure adjacent to the target tissue such that the tissue is brought together. The magnetic devices are typically deployed such that the opposite magnetic poles of the magnets will attract and bring the tissue together. Both devices can be deployed inside the body, or one can be deployed inside the body while the other is deployed outside the body. Once the magnets have been deployed, the tissue defined by the magnetic structures can be cut to provide an immediate anastomosis, as Figure 2BAs shown. In other embodiments, the tissue defined by the device will be allowed to necrose and degrade, thereby providing an opening between the tissues. Although the drawings and structures of the present disclosure mainly relate to annular or polygonal structures, it should be understood that the delivery and construction techniques described herein can be used to fabricate various deployable magnetic structures. For example, self-assembling magnets can be reassembled into polygonal structures, such as circular, oval, square, hexagonal, octagonal, decagonal, or other geometric structures that produce a closed loop. As needed, the device can additionally include a handle, suture loop, barbs, and protrusions to achieve the desired performance and make delivery (and removal) easier.

[0082] As described with respect to the drawings, the self-assembling magnetic anastomosis device can be placed using a variety of techniques, such as endoscopy, laparoscopy, or catheter (e.g., without direct visualization, fluoroscopy, etc.). Regardless of the method of device delivery, it is important to note that after confirming magnet coupling, the procedure for creating the anastomosis can be terminated without perforating the tissue. As previously mentioned, the compressive anastomosis process can be allowed to proceed over the following days, resulting in the natural formation of an opening between the tissues. The fused magnets can be allowed to naturally expel, or the magnets can be retrieved during a subsequent surgical procedure. Alternatively, if immediate bypass is needed, the tissue defined by the magnets can be cut or perforated. The perforation can be achieved by various techniques, such as cauterization, micro-knife, or balloon dilation of the tissue after the entry of a needle and guide wire.

[0083] In some embodiments, the self-assembling magnetic device is used to create a bypass in the gastrointestinal tract. Such a bypass can be used to treat cancerous obstructions, weight loss, or Barrico, or even to treat diabetes and metabolic diseases (i.e., metabolic surgery). This bypass can be created by endoscopy, laparoscopy, or a combination of both. Figure 3 Illustrated are various gastrointestinal anastomosis targets that can be addressed using the device of the present invention: stomach-small intestine (A), stomach-large intestine (E), small intestine-small intestine (C), small intestine-large intestine (B), and large intestine-large intestine (D). During an endoscopic procedure, two simultaneous endoscopes can be used to deliver the self-assembling magnetic device, e.g., an upper endoscope or enteroscope located in the upper small intestine, and a colonoscope located in the lower small intestine, as Figure 4A shown. Alternatively, as Figure 4B shown, two simultaneous upper endoscopes (e.g., one located in the stomach and a second located in the small intestine) can be used to place the device. In other embodiments, the self-assembling magnets can be sequentially delivered through the same endoscope that has been moved between a first deployment location and a second deployment location. For example, in Figure 4A , a single per-oral endoscope can deliver and deploy one self-assembling magnet in the small intestine, withdraw, and then deploy a second complementary magnet in the stomach. Similarly, fluoroscopy can be used to confirm magnet coupling. Figure 5Shows the removal of a single endoscope after placement of two magnetic devices.

[0084] Various techniques can be used to detect the first deployed magnetic device to assist in the placement of the second mating structure. Once the first device is deployed at the desired anastomosis location, the two deployed magnetic devices need to find each other's magnetic fields so that they can mate and provide the compressive force required to facilitate anastomosis formation. Ideally, the devices can be located within a few centimeters of each other (e.g., using ultrasound), at which point the magnets should self-capture and self-align. In cases where this is not possible, other techniques can be used, such as one of the following. The first positioning technique involves a direct contact method using two endoscopes. Here, displacement of one endoscope within an adjacent lumen creates a displacement seen by the other endoscope within the adjacent lumen. This displacement identifies potential intersection points of the anastomosis location. For example, a magnetic deployment tool (described below) will be deflected by the presence of a deployment device on the other side of the tissue wall.

[0085] The second positioning technique involves transmission illumination, whereby high-intensity light from one endoscope is directed at the wall of the lumen at the proposed anastomosis site. Using this technique, the other endoscope within the adjacent lumen looks for the light, which diffuses through the lumen wall and projects onto the wall of the adjacent lumen. This light indicates a potential intersection anastomosis point. A cap or lens can also be placed on the illuminating endoscope to further enhance and precisely locate the proposed intersection point. Similar techniques can use radio waves or ultrasonic transducers and receivers in conjunction with the endoscope tip. In some embodiments, the system can include an endoscope with sensors and a magnetic anastomosis device for deployment using the endoscope.

[0086] The third positioning technique involves magnetic sensing techniques to determine the proximity of the deployed toroidal magnets within adjacent lumens. By maximizing the sensed magnetic field, the minimum distance between adjacent channels can be identified. The magnetic sensor can be carried on a probe inserted along the working channel of the endoscope and utilize common magnetic sensing techniques such as Hall effect sensors or reed switches.

[0087] Using transmission illumination and magnetic sensing, additional accessories can also assist in delivering the magnetic devices to the precise anastomosis site. A radially expanding ring structure can be deployed with an endoscope or laparoscope that can press-fit and seat itself on the outer diameter of the endoscope. The outer diameter of the expansion element is sized to allow the deployed device to seat itself on the expansion element (also likely a press-fit). With the expansion element and the magnetic device radially positioned around the endoscope axis, the endoscope can be guided to the ideal anastomosis position by direct contact, transmission illumination, or magnetic sensing, and then release the mating magnet device when the anastomosis site is identified.

[0088] In other embodiments, ultrasound guidance (e.g., endoscopic ultrasound) can be used to deliver the self-assembling magnet device. For example, using an echoendoscope in the stomach, suitable small intestine targets can be identified. As Figure 6 shown, a delivery needle 600 (e.g., an aspiration needle) or catheter can be used to access the small intestine target and deliver the self-assembling magnet into the small intestine lumen. Delivery can be guided by fluoroscopy or endoscopic ultrasound. After self-assembly, these small intestine magnets will couple with a second set of magnets deployed in the stomach. The two devices can be delivered with the same needle or different needles. The first device can also be delivered endoscopically and the second device delivered with a needle, and vice versa.

[0089] In Figure 7 another embodiment shown, a first anastomosis formed during an initial surgery can be used to provide a pathway for forming a second anastomosis. This process can theoretically be repeated multiple times to create additional anastomoses. For example, a gastrojejunostomy (stomach to mid-small intestine) can be used as a conduit for creating a second, more distal gastrojejunostomy. Eventually, in this particular case, the stomach will have several bypasses to the small intestine. Additionally, in some cases, more anastomoses can be added to "titrate" to a specific clinical effect (e.g., lower glycated hemoglobin in type 2 diabetes). In alternative embodiments, anastomoses can be placed to provide access for different types of surgeries (e.g., tumor removal).

[0090] In another embodiment of delivery, the self-assembling magnet can be delivered through a surgical incision into the target organs (e.g., the stomach and small intestine) using laparoscopy and allowed to couple to create an anastomosis, as Figure 8 shown. Again, the procedure can utilize fluoroscopy or ultrasound for guidance, and the procedure can be a pure laparoscopic procedure, or a combination of endoscopic and / or laparoscopic and / or needle procedures.

[0091] Gastrointestinal anastomoses can be used to address a variety of conditions. Anastomoses between the proximal and distal intestine or a series of anastomoses can be used to treat obesity and metabolic conditions such as type II diabetes and dyslipidemia. The procedure can also be used to induce weight loss and improve the metabolic profile, such as the lipid profile. The intestine includes any segment of the digestive tract extending from the pyloric sphincter of the stomach to the anus. In some embodiments, anastomoses are formed to bypass diseased, malformed, or dysfunctional tissue. In some embodiments, anastomoses are formed to alter the "normal" digestive process in an effort to reduce or prevent other diseases such as diabetes, hypertension, autoimmune, or musculoskeletal diseases.

[0092] Using self-assembling magnetic devices as discussed herein, side-to-side anastomoses can be created that do not require resection of intervening tissue, as is common in prior art bariatric surgery. That is, using the devices of the present invention (or other devices for creating anastomoses), alternative paths can be created that are partial bypasses of fluids (e.g., gastric juices) and nutrients (e.g., food), while maintaining at least a portion of the old path. This design allows adjustment of the ratio of "normal" to "modified" digestion based on the goals of the procedure. In other words, using the described process, a physician can select the ratio of food / fluid diverted along the new (partial) bypass to that diverted along the old path. In most cases, the portion diverted along the bypass branch will drive the patient towards the desired clinical endpoints (e.g., weight loss, improvement in glycosylated hemoglobin, improvement in lipid profile, etc.). For example, the mechanism for achieving the endpoint may involve early delivery of macronutrients to the ileum, stimulation of L cells, and increased GLP-1 production. The mechanism may also involve a loss of efficiency in nutrient absorption (especially glucose), thereby reducing blood glucose levels. However, at the same time, the portion diverted along the old path prevents known metabolic complications that may be associated with bariatric surgery, such as weight regain, dumping syndrome, electrolyte derangements, malnutrition, etc.

[0093] To achieve the desired bypass ratio (e.g., redirecting food and secretions to flow along the new path, say 70% or 80% or 90% or 100% of the time), the size, location, and possibly the number of anastomoses will be important. For example, for a gastrojejunal anastomosis, it may be crucial to place the anastomosis in a dependent manner to take advantage of gravity. Also, instead of a circular anastomosis, a long oval anastomosis may be better formed to maximize the anastomosis size. Alternatively, multiple gastrojejunal anastomoses can be used to titrate to a specific clinical endpoint (e.g., glycosylated hemoglobin in type II diabetes). Most of the procedures described herein can be used to place one or more anastomoses as needed to achieve the desired clinical endpoint. For example, Figure 4A and Figure 4B the two endoscopic procedures shown can be used to create a partial bypass of a portion of the intestine. Based on the desired ratio of bypassed to non-bypassed nutrients, Figure 4A and Figure 4B the anastomoses shown in can be made larger, e.g., with an opening diameter greater than 1 cm, or several smaller anastomoses can be placed to achieve the desired ratio.

[0094] The process is also adjustable. For example, a first anastomosis can be formed, and then based on clinical tests performed after the surgery, one or more anastomoses can be added to improve the results of the clinical tests. Based on subsequent clinical results, another anastomosis may be required. Alternatively, the state can be partially reversed by closing one or more anastomoses. Since the tissues that have been partially bypassed are not removed, they can return to near-normal function as a greater amount of nutrients, etc. pass through. The anastomoses can be closed with clamps, sutures, staples, etc. In other embodiments, plugs can be placed in one or more anastomoses to limit the rate of nutrients passing through the "normal" pathway. Additionally, an anastomosis can be closed at one location in the intestine and then a new anastomosis can be placed at a different location. Thus, it is possible to substantially and tunably create a partial bypass or a series of partial bypasses between parts of the intestine to achieve a clinical endpoint, e.g., as Figure 3 described.

[0095] The described surgery can also be used in combination with surgeries to remove or block the bypassed tissue, which is common in bariatric surgery. For example, a gastrojejunostomy can be coupled with a pyloric plug (gastric obstruction) or another closure of the pylorus (e.g., suture closure) to divert food completely downward to the new bypass. Such surgeries can be used, for example, to bypass diseased tissue, such as due to cancer.

[0096] In another class of surgeries, endoscopic ultrasound (EUS) can be used to facilitate a guided transgastric or transconversion into the gallbladder for placement of a self-assembling magnetic anastomosis device. Once access to the gallbladder is obtained, various strategies can be employed to maintain patient access between the stomach and the gallbladder or between the duodenum and the gallbladder. In another embodiment, gallstones can be retrieved endoscopically and fluid can be drained. For example, using the described method, an anastomosis can be formed between the gallbladder and the stomach. Once access to the gallbladder is achieved via a transgastric or transductive approach, the gallstones can be removed. Additionally, any number of modalities can be used to ablate the gallbladder mucosa, including but not limited to argon plasma coagulation (APC), photodynamic therapy (PDT), sclerosing agents (e.g., ethanolamine or ethanol).

[0097] One strategy for forming the access is to deploy self-assembling magnets into the gallbladder and also into the stomach or duodenum via an endoscopic needle under ultrasound guidance. These magnets will mate and form a compression anastomosis or fistula. A second strategy for forming the access is to deploy self-assembling magnets via an endoscopic needle 600, as Figure 9A and Figure 9BAs shown. Although the coupled magnetic components are shown as octagons, the closed frame can take the shape of any polygonal structure, such as square, circle, triangle, hexagon, heptagon, pentagon, decagon, dodecagon, etc. One such device would be deployed into the gallbladder and the mating device would be deployed into the stomach or duodenum. In the same manner as discussed above with respect to gastrointestinal deployment, the tissue bounded by the two magnetic devices can be cut with cautery, a microscalpel, a needle knife, or other deployable cutting mechanism. In another embodiment, the coupled tissue can be necrotized and anastomosed.

[0098] However, the device need not be limited to forming holes. Other structures can be coupled to one or more mating magnet devices to create additional functionality. For example, the stent can be deployed between tissues such as the gallbladder and the stomach, such as Figure 10 Alternatively, the gallbladder magnet can be coupled to a balloon-based device filled with air, fluid, magnetic members, or magnetic particles. When inflated, the balloon will serve as an anchor in the bile duct after placement. The balloon can also have a ring-shaped configuration to allow for immediate access after coupling with a second magnet. See, e.g. Figure 11 However, regardless of the implementation, it is critical that the original entry path is contained within the range of the coupling magnets, i.e., not leaving the path for bile to escape. Otherwise, the opening will allow bile leakage that may lead to peritonitis.

[0099] Another medical application of self-assembled magnets is direct bile duct access. Currently, in order to achieve decompression of malignant bile duct strictures, endoscopic retrograde cholangiography (ERCP) is performed. The bile duct is accessed endoscopically through the papilla in a retrograde manner, and stents are deployed across the stricture over a guidewire. These stents often require subsequent procedures to replace, remove, or place additional overlapping stents. When using the ERCP procedure, replacement and cleaning are required to offset the high infection rate of the bile duct tree (i.e., cholangitis). Due to the high morbidity, ERCP is usually limited to patients who have no other options for addressing pancreatic disease.

[0100] However, using the device of the present invention, anastomosis can be easily formed between the bile duct (preferably, the main bile duct) and the duodenum or stomach (choledo-gastric and choledo-duodenal anastomosis, respectively). This anastomosis is permanent and, if positioned away from the diseased tissue, generally does not require intervention. In one embodiment, the biliary magnetic device is delivered directly into the bile duct under endoscopic ultrasound guidance. As described below, the self-assembled magnetic device is extruded through a needle or catheter, whereupon it is deployed in the correct configuration. Using fluoroscopy or ultrasound, it can then be confirmed that the device has self-assembled and is in the correct position. In some embodiments, the magnetic device can be tethered to the delivery needle or catheter by a detachable wire or suture to achieve mechanical retraction until optimal positioning is confirmed.

[0101] In one embodiment, the magnetic device can be delivered to the bile duct via the duodenal wall through an endoscope, as Figure 12 shown. In another embodiment, the biliary magnet can be delivered to the bile duct in a conventional retrograde manner through the ampulla, as Figure 13 shown. One benefit of retrograde delivery is that it avoids needle punctures across tissue planes, as in the case of the deployment method shown in Figure 12 However, regardless of the method used to deliver the biliary magnet, a second magnetic device is required in the gastric (A) or duodenal (B) lumen, as shown in Figure 14 Typically, this decision depends on the patient's anatomy (e.g., the size of the duodenal lumen) and the position of the initial biliary magnet. In the case of endoscopic ultrasound needle delivery, the second magnetic device can be connected to the biliary magnet via the aforementioned detachable wire and thus extruded through the same delivery needle / catheter. Alternatively, the second device can be pre-attached to the outside of the endoscope and slid into position for coupling after the biliary magnet is deployed. The latter procedure may be more suitable for forward-view echo endoscopes but can generally be used with endoscopes.

[0102] In another embodiment, the biliary magnet is a balloon-based device filled with air, fluid, magnetic blocks, or magnetic particles, similar to that previously described for gallbladder surgery. When inflated, the balloon will serve as an anchor in the bile duct after placement. In one embodiment, the balloon can have an annular configuration to allow immediate access after coupling with the second magnet. Additionally, similar to the gallbladder surgery described above, the biliary magnetic device can be used with a stent form factor. In one embodiment, the stent has an internal biliary magnet and a hinged external magnet. The stent can be inserted into the bile duct in a retrograde manner through the ampulla. Then, the hinged external magnet can swing around the internal biliary magnet and couple with the internal biliary magnet to form a fistula between the bile duct and the duodenum, as shown in Figure 15 shown.

[0103] The magnetic device of the present invention can also be used to treat pancreatic diseases. For example, the pancreatic duct needs to be decompressed in certain disease states, such as chronic pancreatitis. Currently, extensive pancreatic duct decompression requires surgery (e.g., longitudinal pancreaticojejunostomy, where the pancreas is filtered along the axis of the pancreatic duct and connected to a loop of the small intestine for improved pancreatic drainage). As an alternative to longitudinal pancreaticojejunostomy, extensive pancreatic duct decompression can be achieved by creating a large magnetic compression anastomosis between the pancreatic duct and the stomach or duodenum using a magnetic pancreatic duct, as shown in Figure 16As shown. The catheter can be magnetic along its entire length or only at certain intervals. The catheter can be in the form of a stent or a cannula. The pancreatic duct can be accessed using conventional ERCP methods (retrograde intubation through the ampulla) or by direct needle entry using endoscopic ultrasound (EUS). The magnetic pancreatic catheter can be delivered into the pancreatic duct and coupled to a second magnetic device in the stomach or duodenum. As in the biliary scenario described above, the magnetic pancreatic catheter can be hinged to the second magnetic device.

[0104] Self-assembling magnetic devices can also be used to access and drain fluid collections located near the gastrointestinal tract, such as Figure 17 shown. For example, after pancreatitis, a collection of pancreatic fluid may form that requires drainage. While surgical or percutaneous catheters can be used to achieve drainage, endoscopic drainage has been found to be more cost-effective clinically but can be complicated due to bleeding, perforation, and / or inadequate drainage. As an alternative to surgical drainage, the magnetic devices of the present invention can be delivered into the fluid collection under endoscopic ultrasound (EUS) guidance through a needle or sharp catheter, as Figure 17 shown. After assembly, the first magnetic device is coupled to a second magnetic device that has been placed in the gastrointestinal lumen (e.g., the stomach). To accelerate removal after drainage, as previously described, the first magnet can be tethered by a connecting wire. As previously described, intervening tissue can be cut using electrocautery or dilation, followed by entry of the needle and wire. Additional devices such as magnetic coupling clamps can be used to control blood flow to allow "bloodless" endoscopic access to the fluid collection.

[0105] Self-assembling magnets can also be used in urological applications, such as forming a bypass to treat an obstructed urogenital tract, as Figure 18 shown. For example, a magnetic anastomosis can be formed between the renal calyx and the intestine (A), between the ureter and the intestine (B), or between the bladder and the intestine (C). As described above, the self-assembling magnetic devices of the present invention can be delivered into the urinary tract using an endoscope, laparoscope, or needle. The reciprocating magnetic device can be delivered into the gastrointestinal tract using an endoscope, laparoscope, or needle as previously described. In other embodiments, these devices can be used in reproductive surgery, such as bypassing a partially obstructed fallopian tube or bypassing a vasectomy.

[0106] In yet another application, self-assembling magnetic devices can be used to create a vascular anastomosis or treat heart disease. For example, a magnetic anastomotic coupling can be formed between adjacent blood vessels using a magnetic device, as Figure 19 shown. In one embodiment, the self-assembling device can be delivered using a vascular delivery device such as a catheter. Additionally, as described above for gallbladder and pancreatic applications, a shunt can be installed to bypass a portion of a weak or obstructed vasculature.

[0107] Self-assembling magnets can also be used in pulmonary applications, such as forming a bypass in the airway to treat chronic obstructive pulmonary disease (COPD). For example, a magnetic anastomosis can be created by deploying self-assembling magnetic devices into adjacent bronchioles, as Figure 20 shown. The creation of a lung "bypass" can reduce the airway resistance characteristic of respiratory diseases such as COPD.

[0108] Self-assembling magnetic devices can also be used to create a surgical stoma to divert fecal flow into, for example, a colostomy bag. For example, a magnetic anastomosis can be created by deploying self-assembling magnets into the gastrointestinal tract (e.g., the large intestine), as Figure 21 shown, and then coupling an internal magnet to an external magnet that is worn and secured at the skin level. The external magnet device can be coupled to a third magnet device that is coupled to a collection device. Such a system allows for easy removal of the collection device for cleaning, etc.

[0109] While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily conceive of various other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of these variations and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend upon one or more specific applications of the teachings of this invention. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Accordingly, it is to be understood that the foregoing embodiments are presented by way of example only, and that the inventive embodiments may be practiced otherwise than as specifically described and claimed within the scope of the appended claims and their equivalents. The inventive embodiments of this disclosure relate to each and every separate feature, system, article, material, kit, and / or method described herein. Additionally, any combination of two or more such features, systems, articles, materials, kits, and / or methods which do not mutually contradict each other is included within the inventive scope of this disclosure.

[0110] Various inventive concepts may be embodied as one or more methods, examples of which have been provided. The acts performed as part of a method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than shown, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0111] All definitions, as defined and used herein, should be understood to take precedence over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0112] Unless clearly indicated to the contrary, the indefinite article "a" as used in this specification and the claims shall be understood to mean "at least one".

[0113] The phrase "and / or" as used in this specification and the claims shall be understood to mean "either or both" of the elements so combined, i.e., elements that are present together in some cases and separate in other cases. Multiple elements listed with "and / or" shall be construed in the same manner, i.e., "one or more" of the elements so combined. Other elements may optionally be present, whether related or unrelated to those specifically identified, in addition to the elements specifically identified by the "and / or" clause. Thus, as a non-limiting example, when used in conjunction with open-ended language such as "comprising", a reference to "A and / or B" may in one embodiment refer only to A (optionally including elements other than B); in another embodiment only to B (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); and so on.

[0114] As used in this specification and the claims, "or" shall be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be interpreted inclusively, i.e., including one or more of the elements or items in the list, but also including more than one, and optionally, additional unlisted items. Only terms that clearly indicate the contrary, such as "only one" or "exactly one", or "consisting of" as used in the claims, refer to exactly one element among several elements or a series of elements. Generally, when preceded by an exclusive term such as "any", "a", "only one", or "exactly one", the term "or" as used herein will be interpreted only as indicating an exclusive alternative (i.e., "one or the other but not both"). When used in the claims, "consisting essentially of" shall have its ordinary meaning as used in the field of patent law.

[0115] As used herein in the specification and claims, the phrase "at least one" when referring to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one or each element specifically listed within the list of elements, and not excluding any combinations of elements in the list of elements. This definition also allows that an element may optionally be present rather than an element specifically identified within the list of elements referred to by the phrase "at least one", whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") can in one embodiment mean at least one, optionally including more than one A, where no B is present (and optionally including elements other than B); in another embodiment, it can mean at least one, optionally including more than one B, where no A is present (and optionally including elements other than A); in yet another embodiment, it can mean at least one, optionally including more than one A, and at least one, optionally including more than one B (and optionally including other elements); and so on.

[0116] As used herein in the specification and claims, all transitional phrases such as "comprising", "including", "carrying", "having", "containing", "involving", "holding", "consisting of", etc. shall be understood to be open-ended, i.e., meaning including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" will be closed or semi-closed transitional phrases, as set forth in section 2111.03 of the United States Patent and Trademark Office's Manual of Patent Examining Procedure.

[0117] The features of various embodiments of the present invention may lie in the potential claims listed in the paragraphs following this paragraph (and before the actual claims provided at the end of this application). These potential claims form part of the written description of this application. Thus, the subject matter of the following potential claims may be presented as actual claims in a subsequent process of this application or any application claiming priority based on this application. The inclusion of such potential claims should not be construed to mean that the actual claims do not cover the subject matter of the potential claims. Thus, the decision not to present these potential claims in a subsequent process should not be construed as donating the subject matter to the public. These potential claims are also not intended to limit the various claims sought to be protected.

[0118] Without limitation, potential subject matter that may be claimed (starting with the letter "P" to avoid confusion with the actual claims presented below) includes:

[0119] P1. Each magnetic vertebral segment for a magnetic compression anastomosis device, comprising: a vertebral skin, said vertebral skin comprising a metal alloy, a polymer, and / or a composite material; a flexible segment, said flexible segment being configured as a tensile member; a spring flexible member, said spring flexible member being configured to contribute to forming an array; a roller, said roller being configured to provide radial constraint and limit degrees of freedom to strengthen said array from a torsional angle.

[0120] P2. The vertebra according to claim P1, further comprising: a roller or a node, said roller or node being configured to produce rotation in a plane while limiting the torsional degree of freedom relative to 90 degrees; and a stopper, said stopper being configured to limit one or more degrees of freedom.

[0121] P3. The vertebra according to claim P1, further comprising: a male node of a first vertebra, said male node being configured to interlock with a female node of a second vertebra, wherein said vertebra is shaped to provide interference, thereby allowing a prescribed amount of rotation about the axes of said male node and female node.

[0122] Although the above discussion discloses various exemplary embodiments of the present invention, it should be apparent that those skilled in the art can make various modifications that will achieve some advantages of the present invention without departing from the true scope of the present invention. Any reference to "the present invention" is intended to refer to the exemplary embodiments of the present invention and should not be construed as referring to all embodiments of the present invention unless the context otherwise requires. The described embodiments are considered illustrative rather than restrictive in all respects.

Claims

1. A magnetic compression anastomosis device, the magnetic compression anastomosis device comprises: A first multi-piece internal vertebral support structure, the first multi-piece internal vertebral support structure including a first set of magnets attached to the outward-facing side of the first multi-piece internal vertebral support structure; and A second multi-piece internal vertebral support structure, the second multi-piece internal vertebral support structure including a second set of magnets attached to the outward-facing side of the second multi-piece internal vertebral support structure, wherein the first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together in a sandwich configuration, wherein the inward-facing side of the first multi-piece internal vertebral support structure faces the inward-facing side of the second multi-piece internal vertebral support structure, and the magnets are located on the outward-facing sides of the magnetic compression anastomosis device.

2. The device according to claim 1, wherein, The first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together by welding.

3. The device according to claim 1, wherein, The first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together by bonding.

4. The device according to claim 1, wherein, The first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together by die forging.

5. The device according to claim 1, wherein, The first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure are attached together by stamping.

6. The device according to claim 1, wherein, Each magnet has a north pole and a south pole, and wherein all north poles face outward, such that both sides of the magnetic compression anastomosis device have all north pole magnets.

7. The device according to claim 1, wherein, Each magnet has a north pole and a south pole, and wherein all south poles face outward, such that both sides of the magnetic compression anastomosis device have all south pole magnets.

8. The device according to claim 1, wherein, The magnets are attached to the multi-piece internal vertebral support structure using an adhesive.

9. The device according to claim 1, wherein, The magnets are attached to the multi-piece internal vertebral support structure using mechanical fasteners.

10. The device according to claim 1, wherein, The magnets are attached to the multi-piece internal vertebral support structure using clamps.

11. The device according to claim 1, wherein, The magnets are attached to the multi-piece internal vertebral support structure using interlocking elements.

12. The device according to claim 1, the device further comprises: At least one flexible element that biases the multi-piece internal vertebral support structure towards an assembled configuration.

13. The device according to claim 12, wherein, The assembled configuration is circular.

14. The device according to claim 13, wherein, The assembled configuration is polygonal.

15. The device according to claim 1, wherein, Each of the first multi-piece internal vertebral support structure and the second multi-piece internal vertebral support structure includes a plurality of interconnected internal vertebral elements having male ends opposite female ends, wherein the ends of opposite genders are configured to interlock and engage the elements together.

16. The apparatus according to claim 15, wherein, the respective interconnected internal vertebral elements are connected by bolts.

17. The apparatus according to claim 15, wherein, the respective interconnected internal vertebral elements are connected by rivets.

18. The apparatus according to claim 15, wherein, the respective interconnected internal vertebral elements are connected by fasteners.

19. The apparatus according to claim 15, wherein, the connection between the respective interconnected internal vertebral elements is configured to allow rotation along an axis while also restricting torsional movement.

20. The apparatus according to claim 1, wherein, the multi-piece internal vertebral support structure is formed of a metal alloy, a polymer, and / or a composite material.

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