Magnetic compression anastomosis device with multiple internal vertebral support structures

Abstract

The magnetic compression anastomosis device includes a first multi-piece internal vertebral support structure including a first magnet set 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 magnet set attached to an outward-facing side of the second multi-piece internal vertebral support structure, the first and second multi-piece internal vertebral support structures attached to each other in a sandwich configuration, with the inward-facing side of the first multi-piece internal vertebral support structure facing the inward-facing side of the second multi-piece internal vertebral support structure and the magnets on the outward-facing side of the magnetic compression anastomosis device.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 400,904, filed August 25, 2022, entitled "SUPPORT FOR MAGNETIC SEGMENTS OF A MAGNETIC ANASTOMOSIS DEVICE," which is incorporated herein by reference in its entirety.

[0002] 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 desired sites to improve the accuracy of anastomosis formation between tissues, organs, or the like.

[0003] Background technology Bypasses in the gastrointestinal (GI), cardiovascular, or urinary systems are typically created by drilling holes in tissue at two locations and joining the holes with sutures or staples. The bypass is typically placed to route fluids (e.g., blood, nutrients) between healthy parts of the system while bypassing diseased or dysfunctional tissue. This procedure is typically invasive and exposes patients to risks such as bleeding, infection, pain, and adverse reactions to anesthesia. Furthermore, bypasses created with sutures or staples can be complicated by postoperative leaks and adhesions. Leaks can lead to infection or sepsis, while adhesions can lead to complications such as intestinal strictures and blockages. Traditional bypass procedures can be completed endoscopically, laparoscopically, or robotically, but joining the holes cut in the tissue can be time-consuming. Furthermore, such procedures require specialized expertise and equipment that are not available in many surgical facilities.

[0004] As an alternative to sutures or staples, surgeons can use mechanical couplings or magnets to create a compression anastomosis between tissues. For example, a compression coupling or a pair of magnets can be delivered to the tissues to be joined. Due to the strong compression, the tissue trapped between the coupling or magnets becomes disconnected from its blood supply. Under these conditions, the tissue necrotizes and degenerates, while new tissue grows around the compression point, e.g., at the edges of the coupling. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0005] Nevertheless, the difficulty of placing magnets or couplings limits the locations where compression anastomoses can be used. In most cases, magnets or couplings must be delivered as two separate assemblies, requiring either an open surgical field or bulky delivery devices. For example, existing magnetic compression devices are limited to structures small enough to be deployed with a delivery conduit, such as an endoscopic instrument channel or laparoscopic port. When these smaller structures are used, the anastomosis formed is small and suffers from short-term patency. Furthermore, magnet or coupling placement can be imprecise, potentially resulting in anastomosis formation in an undesirable or inaccurate location.

[0006] Thus, there remains a clinical need for reliable devices and minimally invasive procedures that facilitate the formation of compression anastomoses between tissues in the human body.

[0007] Summary of the Invention During deployment of a self-forming magnetic array, control of the individual magnetic pieces is important. Restricting the degrees of freedom to a specific set of parameters provides improved durability and geometric control. When connecting two separate magnets, it is also important that the geometries align to create a compression region with pressure high enough to block fluid exchange to tissues surrounding the geometry formed by the self-forming array.

[0008] One embodiment of the present invention utilizes independent magnets connected by a multi-piece vertebra design. Previous innovations utilize a single formed piece of alloy to form the support. This invention utilizes individual flexion segments that connect to the flexion armature, vertebra casing, and either "rollers" or integral "rolling nodes" to limit degrees of freedom during formation and increase durability.

[0009] During coupling of two magnetic arrays, the ability to sense the mating array is more easily achieved with a single pole face. One embodiment of the present invention provides an internal skeleton that presses the same pole faces together.

[0010] More specifically, according to one embodiment of the present invention, the 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, the first and second multi-piece internal vertebral support structures being attached to one another in a sandwich configuration, with the inward-facing side of the first multi-piece internal vertebral support structure facing the inward-facing side of the second multi-piece internal vertebral support structure and the magnets on the outward-facing side of the magnetic compression anastomosis device.

[0011] In various alternative embodiments, the first and second multi-piece internal vertebral support structures may be attached to one another by, for example, welding, adhesive bonding, swaging, or stamping. Each magnet may have a north and a south pole, with all of the north or all of the south poles facing outward so that both sides of the magnetic compression anastomosis device have magnets of the same polarity. The magnets may be attached to the multi-piece internal vertebral support structures using, for example, adhesives, mechanical fasteners, clamps, or interlocking elements. The device may further include at least one flexible element that biases the multi-piece internal vertebral support structures toward the assembled configuration. The assembled configuration may be circular or polygonal. Each of the first and second multi-piece internal vertebral support structures may include multiple interconnected internal vertebral segments having opposing male ends, with the opposing female and male ends configured to connect and join the segments to one another. Such interconnected individual internal vertebral segments may be connected by bolts, rivets, or fasteners. Generally speaking, the connections between the individual interconnected internal vertebral fragments are configured to allow rotation along the axis while also restricting torsional motion. The multi-piece internal vertebral support structure can be formed from metal alloys, polymers, and / or composite materials.

[0012] Additional embodiments may be disclosed and claimed.

[0013] Those skilled in the art will more fully appreciate the advantages of various embodiments of the present invention from the following "Description of Exemplary Embodiments," which is described with reference to the drawings summarized immediately below. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 shows a magnet assembly delivered through an endoscope instrument channel so that the individual magnets self-assemble into a larger magnetic structure, in this particular case an octagon. [Figure 2A] FIG. 10 shows the magnet assembly delivered and deployed in adjacent tissue. [Figure 2B] 10 illustrates two magnet assemblies coupled together by magnetic attraction to capture intervening tissue. In some cases, an endoscope can be used to cut the circumscribed tissue. [Figure 3] Diagram showing several potential anatomical targets for anastomosis creation. Arrow A is from stomach to small intestine, arrow B is from small intestine to large intestine, arrow C is from small intestine to small intestine, arrow D is from large intestine to large intestine, and arrow E is from stomach to large intestine. [Figure 4A] FIG. 10 illustrates one embodiment of delivery using two endoscopes (a colonoscope and an enteroscope or gastroscope) to deliver the magnet assembly. [Figure 4B] FIG. 10 illustrates another embodiment of delivery using two upper endoscopes, both sharing a transoral portal for delivering the magnet assembly. [Figure 5] 10A-10C illustrate another embodiment of delivery in which the magnet assemblies are delivered sequentially using a single endoscope. [Figure 6] FIG. 10 illustrates another embodiment of delivery using endoscopic ultrasound guide needle delivery into lumen #1 of one magnet assembly followed by deployment into lumen #2 of a second magnet assembly. [Figure 7] FIG. 10 illustrates the creation of a preliminary anastomosis to serve as a conduit for deeper endoscopic delivery to create subsequent multiple anastomoses. [Figure 8] FIG. 1 illustrates laparoscopic magnet device delivery to a lumen (in this example, the stomach). [Figure 9] FIG. 9A illustrates endoscopic ultrasound guided needle delivery of a magnet assembly into the gallbladder, which is coupled with a second magnet assembly in the stomach or duodenum as shown in FIG. 9B. [Figure 10] FIG. 10 illustrates stent deployment between the gallbladder and either the stomach or duodenum. [Figure 11] 10 illustrates another embodiment of an intragallbladder magnet assembly that is a balloon filled with fluid, gas, or magnetic material that is tethered to an endoscope and initially delivered through an endoscopic ultrasound guide needle. [Figure 12] 10A-10C illustrate ultrasound endoscopic needle guided delivery of a magnet assembly into a bile duct. [Figure 13] FIG. 1 illustrates magnet assembly delivery into the bile duct via an endoscopic retrograde cholangiopancreatography technique. [Figure 14] 1A-B show the coupling of an intrabiliary magnet assembly with a second magnet assembly deployed in either the stomach (A) or duodenum (B). [Figure 15] FIG. 10 shows another embodiment of a biliary magnetic anastomosis in which a hinged magnetic biliary stent swings back on itself by magnetic attraction to form an anastomosis between the bile duct and the duodenum. [Figure 16] 1A-1C illustrate a magnetic stent that can be delivered to the pancreatic duct. The stent can be coupled with a magnet in the stomach (A) or duodenum (B) to form a draining anastomosis for the pancreatic duct. [Figure 17] FIG. 10 shows a magnetic assembly delivered to the peripancreatic collection (dotted structure) using endoscopic ultrasound-guided needle / catheter delivery coupled with a second magnetic assembly deployed within the stomach. [Figure 18] FIG. 1 illustrates different targets for anastomosis between the urinary and gastrointestinal systems: the renal calyx (A), the ureter (B) and the bladder (C). [Figure 19] 10A-10C illustrate magnet assemblies within adjacent blood vessels for joining and forming vascular anastomoses. [Figure 20] 1A-1C illustrate magnet assemblies in different parts of the respiratory system for creating anastomoses between adjacent bronchioles. [Figure 21] FIG. 1 shows an external and internal magnet assembly within the digestive tract used to create a surgical stoma for fecal evacuation. [Figure 22] FIG. 10 is an exploded view of a multi-piece vertebra of a self-assembling magnetic compression anastomosis device, in accordance with certain embodiments. [Figure 23] 23 is an enlarged view of the various components shown in FIG. 22, including an example of a flexible element according to certain embodiments. [Figure 24]10A-10C illustrate alternative examples of flexible elements in accordance with certain embodiments. [Figure 25] 1A-1C illustrate various geometric profiles of magnetic segments according to certain embodiments. [Figure 26] 1 illustrates an example of a roller in the form of a torsion spring, according to certain embodiments. [Figure 27] 1A-1C illustrate portions of two multi-piece internal vertebral support structures that can be used to form a sandwich structure, according to certain embodiments. [Figure 28] 1A and 1B illustrate a left vertebral support structure supporting a first set of magnets and a right vertebral support structure supporting a second set of magnets, according to certain embodiments. [Figure 29] 1A-1C illustrate a magnetic compression anastomosis device having interconnected left and right multi-piece internal vertebral support structures, according to certain embodiments.

[0015] It should be noted that the foregoing figures and the elements depicted therein are not necessarily drawn to consistent or any scale. Like elements are designated by like numerals unless the context suggests otherwise. The drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein.

[0016] MODE FOR CARRYING OUT THE INVENTION Exemplary embodiments provide improved devices and techniques for minimally invasive formation of anastomoses within the body, for example, the digestive 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 of diseases such as cancer, e.g., stomach or colon cancer.

[0017] The system generally includes an access device configured to be disposed within a patient's hollow body and to assist in the formation of an anastomosis at a target site (desired anatomical location) within the hollow body, between a first portion of tissue in the hollow body at the target site and a second portion of tissue in an adjacent hollow body, such as between the gallbladder and stomach, between the stomach and duodenum, or between the ileum and colon. The access device provides access to the first portion of tissue in the hollow body and is further configured to deliver and position a first implantable magnetic anastomosis device. A second implantable magnetic anastomosis device is delivered to an adjacent hollow body, for example, using the same access device or a second access device. The first and second implantable magnetic anastomosis devices are configured to be magnetically attracted to each other through a defined tissue region of the total thickness of the tissue wall at the target site and to apply a compressive force to the defined region to form the anastomosis.

[0018] The systems, devices, and methods described herein include various access devices for accessing a patient's hollow body, such as the gallbladder, and securing the positioning of the access device for subsequent deployment of one of a pair of magnetic anastomosis compression devices. The systems, devices, and methods described herein further include various delivery devices for delivering at least one of the pair of magnetic anastomosis compression devices to a target site, and in some cases, a delivery device consistent with the present disclosure can assist in the deployment of at least one of the pair of magnetic anastomosis compression devices and their subsequent fixation at the target site and / or coupling of the pair of magnetic anastomosis compression devices to each other. The systems, devices, and methods described herein include various embodiments of the magnetic anastomosis compression device and various designs for transitioning from a compact delivery configuration to a larger deployed configuration, generally via a self-assembling design.

[0019] More specifically, exemplary embodiments provide a system including a delivery device for introducing and delivering a pair of magnetic assemblies between adjacent organs via minimally invasive techniques to bridge the tissue walls of each organ together, thereby forming a passageway (i.e., anastomosis) therebetween. The delivery device is particularly useful for delivering the pair of magnetic assemblies to a target site within the digestive tract, thereby forming an anastomosis between the walls of the stomach and gallbladder to provide adequate drainage from the gallbladder when an obstruction occurs (due to disease or other health-related problem).

[0020] Thus, the illustrative embodiments provide improved devices and techniques for minimally invasive formation of anastomoses within the body, for example, the digestive 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 of diseases such as cancer, e.g., stomach or colon cancer.

[0021] For example, in endoscopic procedures, a single endoscope can be used to deliver the self-assembling magnetic device. The exemplary magnetic anastomosis device may be delivered through the endoscope so that the individual magnet segments self-assemble into a larger magnetic structure. When used with the techniques described herein, the device, when deployed as a completed assembly, allows for the delivery of larger magnetic structures than would be possible through a small delivery conduit, such as a standard endoscope. Furthermore, larger magnetic structures allow for the formation of larger, more robust anastomoses, achieving greater surgical success. For example, in some cases, the resulting anastomosis can have a 1:1 aspect ratio relative to the final dimensions of the assembled magnetic device. However, the exemplary embodiments allow for a larger aspect ratio (i.e., a larger anastomosis formed relative to the dimensions of the magnetic assembly). Notably, prior art systems and methods involving the use of magnets to form anastomoses are generally limited based on the dimensions of the working channel of the scope or catheter used to deliver such magnets, thereby limiting the size of the resulting anastomosis. However, the magnetic assembly design of the exemplary embodiments overcomes such limitations. For example, the design of the magnetic assembly, particularly the coupling of multiple magnetic segments to one another via the support, allows any number of segments to be included in a single assembly, and therefore the resulting anastomosis has a larger size relative to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomosis can include aspect ratios ranging from 2:1 to 10:1 or greater.

[0022] Magnetic anastomosis devices generally include magnetic segments that can assume a delivery configuration and a deployed configuration. The delivery configuration is typically linear so that the device can be delivered to tissue via a laparoscopic "keyhole" incision or with an endoscope or similar device, via a natural pathway, such as the esophagus. Furthermore, the delivery configuration is typically somewhat flexible so that the device can be guided through various curvatures within the body. Once delivered, the device assumes the deployed configuration of a desired shape and size by automatically transforming from the delivery configuration to the deployed configuration. The self-transformation from the delivery configuration to the deployed configuration is guided by a linkage structure that moves the magnetic segments in the desired manner without intervention. Exemplary self-assembling magnetic anastomosis devices, such as self-closing and self-opening devices, are described in U.S. Pat. Nos. 8,870,898, 8,870,899, 9,763,664, and 10,182,821, the contents of each of which are incorporated herein by reference in their entirety.

[0023] During deployment of a self-forming magnetic array, control of the individual magnetic pieces is important. Restricting the degrees of freedom to a specific set of parameters provides improved durability and geometric control. When connecting two separate magnets, it is also important that the geometries align to create a compression region with pressure high enough to block fluid exchange to tissues surrounding the geometry formed by the self-forming array.

[0024] 22, the magnetic compression anastomosis device 100 includes a plurality of magnetic segments 101 (note that although three of the eight magnetic segments 101 in this embodiment are numbered, 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.

[0025] The vertebrae 101 are configured to allow movement between the delivery configuration of device 100 (which typically has vertebrae 101 substantially linearly aligned to fit within a delivery device, such as a catheter, endoscope, laparoscope, trocar, needle, or other delivery device) and the fully assembled configuration of device 100 (e.g., a circular or polygonal configuration), while limiting undesirable degrees of freedom, such as torsion, over-rotation, under-rotation, and out-of-plane deflection of one or more vertebrae, which may cause incomplete assembly or non-assembly of device 100. Thus, embodiments of device 100 may be self-assembling devices (e.g., automatically and autonomously transition to a fully assembled configuration upon delivery), although embodiments may additionally or alternatively include additional elements to assist or manually position device 100 in its fully assembled form (e.g., sutures, wires, etc.). For purposes of this description, the plane of device 100 may be considered to be a plane passing through the centers of the vertebrae when in the fully assembled configuration. The vertebrae 1010 include proximal and distal end vertebrae that are magnetically coupled to one another in an assembled configuration to form a circular or polygonal arrangement.

[0026] As described in more detail below, in certain embodiments, each vertebra 101 may be a multi-piece vertebra including a vertebral skin 102 that fully or partially encapsulates one or more magnets 103 and other components described herein. Device 100 can be configured with different magnetic polarity configurations, such as, for example, all vertebrae 101 having the same magnetic polarity, vertebrae 101 having alternating magnetic polarities, vertebrae 101 having alternating pairs of magnetic polarities, vertebrae 101, etc. The present invention is not limited to any particular magnetic polarity configuration.

[0027] Each pair of adjacent interconnected vertebrae 101 is rotatably connected by a cylindrical roller 104. For purposes of this description, the cylindrical rollers are generally hollow cylinders (e.g., tubular), but in some embodiments can be solid cylinders. The rollers 104 can be used to provide radial constraint, limit degrees of freedom, and therefore strengthen the assembly from a torsional perspective. The rollers 104 may be constructed from a metal alloy, a polymer, and / or a composite. The rollers 104 are preferably configured to allow rotation of the vertebrae 101 within the device plane but limit other degrees of freedom. The rollers 104 can include features, such as protrusions or recesses, to help secure the rollers 104 between the two vertebrae 101 and / or to control the amount of rotation that can occur between the two vertebrae 101, for example, to provide radial constraint, limit degrees of freedom, and therefore strengthen the assembly from a torsional perspective. The rollers 104 may be constructed from any suitable material, such as a metal alloy, a polymer, and / or a composite. The rollers 104 may be separate components adapted to fit between two or more magnets 103. Each magnet 103 may include a notch at each end adapted to fit a roller that allows movement in one plane while restricting movement in the opposing plane by 90 degrees.

[0028] Each pair of adjacent interconnected vertebrae 101 also typically includes a flexible element 106 (an example of which is shown in FIG. 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 may include a spring or be formed from a shape memory material) and can apply a bias toward the assembled configuration such that the vertebrae 101 are biased toward the assembled configuration upon delivery of the device 100. The flexible element 106 can be constructed of any suitable material, such as a metal alloy, polymer, and / or composite, particularly a shape memory material. In various embodiments, the flexible segment is positioned between two vertebral skins at the periphery of the array. However, it should be noted that the flexible segment may also be positioned at the inner periphery of the array. The flexible segment helps to stiffen the array and limit its degrees of freedom. The flexible member can also help the array unfold into its properly assembled geometry.

[0029] The vertebral skin 102 may be formed of a suitable material, such as a metal alloy, polymer, and / or composite, and may in particular be formed of or include a shape-memory material. The vertebral skin 102 encapsulates the magnet 103 and helps secure the rollers 104 and flexible elements 106 within the device 100, providing a protective layer while limiting degrees of freedom. The vertebral skin 102 may be secured onto the magnet 103 with or without additional fasteners, such as screws, pins, adhesives, or interlocking elements. Thus, for example, with the magnet 103, rollers 104, and flexible elements 106 positioned for assembly, the vertebral skin 102 may be placed over the magnet 103, rollers 104, and flexible elements 106 to encapsulate the components. As shown, the vertebral skin 102 may incorporate male and female nodes 108 and 110 at opposite ends of the vertebra, which may interact with opposing gender nodes on another vertebra. The male nodes 108 of one segment mate or interface with the female nodes 110 of the other segment. The incorporated nodes support movement in one plane while restricting other degrees of freedom. The male nodes 108 can help secure the rollers 104 and / or flexible elements 106 within the device 100. The incorporated nodes can include stops to restrict additional degrees of freedom, for example, to prevent "backward bending" or excessive "forward bending" of the array, as shown in FIG. 112. The stops can provide vertebral interference while allowing a predetermined amount of rotation about the axis of male and female node interaction.

[0030] FIG. 23 is an expanded view of the various components shown in FIG. 22 , also showing an example of a flexible element 106, which in this example is in the form of a bar with a central spring portion formed, for example, of a shape memory material. Without limitation, the flexible element 106 can be configured to fit within the channel 114 of the magnet 103 or any other configuration that allows the flexible element 106 to control the movement of the vertebrae 101, such as biasing the vertebrae 101 toward the assembled configuration (e.g., the flexible element 106 may include a flexible element support 105 above or below the rollers 104 on which the flexible element 106 rests to provide a fulcrum for the flexible element 106). Embodiments can include one, two, or more flexible elements 106 and associated elements, such as elements 105 and 114, e.g., flexible elements 106 positioned on either side of the vertebrae 101. The flexible element 106 may be a single device or may include multiple components.

[0031] FIG. 24 illustrates an alternative flexible element 106, which includes two opposing U-brackets that act as biasing springs in a manner similar to the flexible element 106 described above with reference to FIG. 23, along with rollers 104 and magnets 103, as shown in FIG. 116. Specifically, a U-bracket can be located at each end of the magnetic segment. The U-brackets hold the rollers 104 in place, allowing rotation in one plane but restricting out-of-plane movement. The U-brackets can be constructed from any suitable material, such as metal alloys, polymers, and / or composites, and may be formed from or include shape-memory materials, among other materials. The U-brackets allow in-plane movement while restricting torsional movement and 90-degree opposite in-plane movement. The rollers and U-brackets can fit directly into the magnetic segment or into the vertebral skin; for example, the U-brackets can fit through and be secured to the rollers 104, as shown in FIG. 116, and extend along the length of the magnetic segment, for example, into channels 114. The rollers 104 may include flexible element supports that secure the U-brackets in a position that allows for biasing into the assembled configuration. By interlocking the rollers 104 with the magnets 103, the rollers 104 and U-brackets 106 provide structure and shape to the array while also helping to reinforce and prevent torsional motion within the array. This allows for more control over the final placement of the magnetic compression anastomosis device and prevents undesirable geometries from forming.

[0032] As shown in FIG. 25, various profiles of different shapes of magnetic arrays are possible in the vertebrae 101 of the present invention. For example, the vertebral skin 102 can include smooth and / or patterned features and can be configured with different outer shapes to achieve different anastomosis goals. For example, geometric shape (a) has a concave surface, geometric shape (b) has a convex surface with a notch, geometric shape (c) has pointed lateral protrusions that can aid in cutting tissue, and geometric shape (d) has a flat surface that can compress and necrotize larger areas of tissue. The vertebrae 101 can include other features, such as various types of protrusions or recesses, to help secure the device 100 to tissue. All vertebrae can use the same geometric shape, or different vertebrae can use different geometric shapes.

[0033] It should be noted that while the above-described embodiment has the flexible element 106 encapsulated beneath the vertebral skin, alternative embodiments may position the flexible element 106 outside the vertebral skin.

[0034] It should be noted that while two exemplary 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 coil spring. In some embodiments, a spring (e.g., a coil spring or a torsion spring) may function as both a roller and a flexible element, as shown, for example, schematically in FIG. 26 .

[0035] It should be noted that in certain embodiments, device 100 may be provided within a delivery device, such as a catheter, endoscope, laparoscope, trocar, needle, or other delivery device, and thus a delivery device in combination with device 100 may be considered an embodiment of the present invention.

[0036] Embodiments may also include methods of manufacturing device 100 by providing various components (e.g., magnets, rollers, flexible elements, and vertebral skin), placing the rollers and flexible elements between two magnets, securing them as needed (e.g., securing the flexible elements within the magnet channels), placing the vertebral skin over the magnets, rollers, and flexible elements, etc.

[0037] It should be noted that the kit may include magnets, rollers, flexible elements, and different types of vertebral skin having different configurations that can be used for different types of anastomosis procedures, such that different devices 100 can be prepared depending, for example, on 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.

[0038] Certain alternative embodiments utilize an internal vertebral support structure, such that each magnetic segment is essentially formed as a sandwich structure with two outer magnets separated and supported by an internal vertebra. The internal vertebra can be formed in one, two, or more pieces. The vertebrae can be interconnected to form a self-assembling magnetic compression anastomosis device, and elements of the type described above with reference to Figures 22-26 can be used to limit undesirable degrees of freedom.

[0039] FIG. 27 illustrates portions of two multi-piece internal vertebral support structures that can be used to form a sandwich structure, according to certain embodiments. As shown in FIG. 28, the left vertebral support structure shown in FIG. 27 can support a first set of magnets, and the right vertebral support structure shown in FIG. 27 can support a second set of magnets. Importantly, each of the vertebrae shown in FIG. 28 can support magnets with the same outward-facing polarity, so that when two sets of vertebrae are interconnected to form a magnetic compression anastomosis device with internal supports, as shown in FIG. 29, both sides of the resulting magnetic compression anastomosis device can have the same magnetic polarity. In the example shown in FIGS. 28-29, the segments of the magnetic compression anastomosis device have north poles on both sides (referred to herein as NN segments). Similar magnetic compression anastomosis devices can be formed with segments with south poles on both sides (referred to herein as SS segments). Notably, having a first magnetic compression anastomosis device with all outward-facing north poles and a second magnetic compression anastomosis device with all outward-facing south poles can facilitate mating of the first and second magnetic compression anastomosis devices, since the devices can be mated on both sides and can attract each other from greater distances. Of course, the segments can be configured with other polarities, such as north on the left side and south on the right side (referred to herein as north-south segments) or south on the left side and north on the right side (referred to herein as south-north segments). Also, 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 the magnetic compression anastomosis device can have different types of segments, such as alternating NN and SS segments, or other segment arrangements.

[0040] The magnets can be secured 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 for biasing the device toward the assembled configuration, for example, one or more flexible elements coupled between two internal vertebral support structures.

[0041] Furthermore, during mating of two magnetic arrays, the ability to sense the mating arrays is more easily achieved with a single pole face. Various embodiments of the present invention utilize internal supports to press identical pole faces together. The magnetic arrays may be mechanically held to the internal skeleton or may be glued. Individual internal skeletons may be joined by various methods, including, but not limited to, welding, gluing, swaging, and / or stamping. The individual and / or linked portions of the internal skeleton provide an internal frame that resists the stress of the magnetic segments pressing against the pole faces. Aligning the magnetic poles of the magnetic segments to have a full north face and a full south face on the array provides many advantages, such as allowing for a greater sensing distance for opposing pole magnetic arrays and many possible orientations of the arrays during mating.

[0042] The individual internal vertebral fragments can be fabricated from, for example, metal alloys, polymers, and / or composite materials. As shown in Figures 27-29, the internal vertebral fragments generally have a shape similar to, but different from, the shape of the magnetic segments. The individual internal vertebral fragments can have male ends opposite female ends, and the opposing male and female ends can be joined to connect the fragments together. The individual internal vertebral fragments can also be connected to each other by bolts, rivets, and / or other fasteners. The connection points between the internal vertebral fragments allow rotation along the axis while also restricting torsional movement. This allows the internal vertebral fragments, when coupled to the magnetic segments, to move in a plane and transform from a delivery configuration to a deployed configuration.

[0043] The internal vertebral fragments may be mechanically held or glued onto the magnetic array. Individual internal vertebrae can be joined by a number of methods, including, but not limited to, welding, bonding, swaging, and / or stamping. As shown in Figure 7, the magnetic segments are attached to the internal vertebral fragments with their magnetic poles facing each other on the inside, allowing the full magnetic pole to face outward. The mating arrays have the same orientation, presenting a full north pole on the outside and a full south pole on the inside. By presenting a full magnetic pole on the outside, the array has a greater sensing distance, and the rotational direction of the array does not need to be specific. An internal skeleton can be used alone or in combination with an external vertebral support to add structure and support while allowing movement in selected degrees of freedom.

[0044] After the magnetic arrays are mated, the internal skeleton is mated inside the mating system. As shown in Figure 28, the total magnetic poles of the arrays are opposed, such as two full normals and two full sources, inside the anastomosis system. These opposing poles are mated using the medial vertebrae. This results in two north poles on the outside and two south poles on the inside of the anastomosis system. Arrays may also be configured with two south poles on the outside and two north poles on the inside of the anastomosis system. Utilizing total magnetic poles increases the sensing distance between the arrays, and when two separate magnets are connected, their geometries align, creating a compression region with pressure high enough to block fluid exchange to the tissue around the geometry created by the self-forming array. This results in a more robust and secure anastomosis with a higher success rate.

[0045] It should be noted that self-assembling magnetic anastomosis addresses some of the historical shortcomings of traditional anastomosis, such as enabling minimally invasive, surgical-quality anastomoses using devices that reproducibly reassemble in vivo into larger magnetic structures of a predetermined shape. The constraints imposed by the described embodiments are designed to allow the devices to consistently self-assemble into the correct shape upon deployment, which significantly reduces the risk of surgical complications due to deformed devices or premature detachment, and also reduces the risks associated with surgical access and ensures that the anastomosis is formed with the correct geometric attributes. Overall, this ensures the patency of the anastomosis.

[0046] Thus, as described herein, embodiments include flexible linear magnetic devices that include linked multi-pole segments that self-assemble to form a rigid multi-pole polygonal ring magnet (PRM; generally, a "magnetic device") when extruded from the end of a deployment channel or lumen. 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 speaking, the physical and magnetic structure of the deployed magnetic device is such that when two magnetic devices approach each other, there is a rapidly strengthening attractive magnetic interaction that creates a bond between the magnetic devices. In some instances, complementary devices must be pre-aligned, while in other instances, the devices self-align by undergoing a rapid in-plane rotation relative to each other, as described in more detail below. As described in more detail below, systems including the magnetic device can include an endoscope with a sensor that enables the endoscope to sense the position of a mating magnetic device or another endoscope deploying a mating device.

[0047] When placed in adjacent tissue, such as adjacent organs or different regions of the same organ, the coupled magnetic devices form a compression ring that can be surgically opened or an anastomosis can be formed without further intervention. If the paired devices are left alone, the compression force on the tissue collapses the vasculature and forces fluid into the tissue, further reducing the distance between the devices and increasing the magnetic attraction. Over time, the coupled devices eventually fully couple and fall off, leaving behind a formed anastomosis. This cascade begins when the devices approach within a "field of view," whereby their mutual attraction is sufficient to align the devices, capture the intervening tissue, and resist the tissue's natural flexibility and movement under normal physiological function.

[0048] Overall, the device design specifications 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 instrument passageway), the thickness of the target tissue, and the inner diameter of the guide channel and the minimum radius of curvature around which the guide channel can be bent and through which the magnet must pass. Once the design specifications are selected, the corresponding magnetic device design, e.g., the side count and length of the polygon and the maximum lateral dimension of the flexible linear magnetic structure deployed via the delivery instrument, can be determined.

[0049] Deployment of device 100 is shown schematically in FIG. 1. When used with the techniques described herein, the device allows for the delivery of larger magnetic structures than would be possible through a small delivery conduit, such as a standard endoscope, when the device is deployed as a completed assembly. Furthermore, larger magnetic structures allow for the formation of larger, more robust anastomoses, achieving greater surgical success. Because magnetic devices are generally radiopaque and echogenic, the device can generally be positioned using fluoroscopy, direct visualization (transillumination or tissue indentation), and ultrasound, e.g., an ultrasound endoscope. The device can also be decorated with radiopaque paint or other markers to aid in identifying the polarity of the device during placement. In some embodiments, the device can be positioned using a sensor placed adjacent to the delivery lumen that can sense the position of the mating device, e.g., using a reed switch or Hall-effect sensor.

[0050] Generally, as shown in FIG. 2A, a magnetic anastomosis procedure involves placing first and second magnetic structures adjacent to target tissues, thus bringing the tissues together. The magnetic devices are typically deployed so that the opposing poles of the magnets attract the tissues together. Both devices may be deployed inside the body, or one may be deployed inside the body and the other outside. Once the magnets are deployed, the tissue surrounded by the magnetic structures can be cut and immediately anastomosed, as shown in FIG. 2B. In other embodiments, the tissue surrounded by the devices necroses and decomposes, providing an opening between the tissues. While the figures and structures in this disclosure primarily relate to circular or polygonal structures, it should be understood that a variety of deployable magnetic structures can be fabricated using the delivery and assembly techniques described herein. For example, self-assembling magnets can reassemble into polygonal structures, such as circles, ellipses, squares, hexagons, octagons, decagons, or other geometric structures that form closed loops. The device may further include handles, suture loops, barbs, and protrusions as needed to achieve desired performance and to facilitate easier delivery (and removal).

[0051] As described with respect to the figures, the self-assembling magnetic anastomosis device can be deployed using several techniques (e.g., without direct visualization, fluoroscopy, etc.), such as endoscopy, laparoscopy, or catheterization. Regardless of the method of device delivery, it is important to note that the procedure for creating the anastomosis can be completed without perforating the tissue after confirmation of magnetic coupling. As previously mentioned, the compression anastomosis process can proceed over the following several days, resulting in the natural formation of an opening between the tissues. The fused magnets can be allowed to release naturally, or the magnets can be retrieved in a follow-up surgical procedure. Alternatively, if immediate bypass is required, the tissue surrounded by the magnets can be cut or perforated. Perforation can be achieved with various techniques, such as tissue cauterization after needle and guidewire access, microscalpel, or balloon dilation.

[0052] In some embodiments, self-assembling magnetic devices are used to create bypasses in the gastrointestinal tract. Such bypasses can be used for cancerous blockages, weight loss or obesity treatment, or even diabetes and metabolic diseases (i.e., metabolic surgery). Such bypasses can be created endoscopically, laparoscopically, or a combination of both. Figure 3 illustrates various gastrointestinal anastomosis targets that can be addressed with the devices of the present invention: stomach to small intestine (A), stomach to large intestine (E), small intestine to small intestine (C), small intestine to large intestine (B), and large intestine to large intestine (D). In endoscopic procedures, as shown in Figure 4A, the self-assembling magnetic devices can be delivered using two simultaneous endoscopes, such as an upper endoscope or enteroscope present in the upper small intestine and a colonoscope present in the lower small intestine. Alternatively, as shown in Figure 4B, the devices can be deployed using two simultaneous upper endoscopes (e.g., one present in the stomach and one present in the small intestine). In other embodiments, the self-assembling magnets can be delivered sequentially through the same endoscope moved between a first and a second deployment position. For example, in Figure 4A, a single transoral endoscope can deliver, deploy, and retrieve one self-assembling magnet in the small intestine, then deploy a second mutual magnet in the stomach. Again, magnetic coupling could be confirmed using fluoroscopy. Figure 5 shows removal of the single endoscope after deployment of the two magnetic devices.

[0053] Various techniques can be used to detect the first deployed magnetic device and 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 must find each other's magnetic fields so that they can mate to provide the necessary compressive force to facilitate the formation of the anastomosis. Ideally, the devices can be positioned approximately within a few centimeters of each other (e.g., using ultrasound), at which point the magnets should self-capture and self-align. If this is not possible, other techniques, such as one of the following techniques, can be used. The first positioning technique involves a direct contact method using two endoscopes. Here, displacement of one endoscope within an adjacent lumen results in displacement as seen by another endoscope within the adjacent lumen. The displacement identifies a potential intersection point for the anastomosis location. For example, a magnetic deployment tool (described below) is deflected by the presence of a deployed device on the opposite side of the tissue wall.

[0054] A second location technique involves transillumination, whereby high-intensity light from one endoscope is directed toward the lumen wall of the proposed anastomosis site. Using this technique, another endoscope in an adjacent lumen looks for light that diffuses through the lumen wall and projects onto the wall of the adjacent lumen. This light represents the potential crossing anastomosis point. A cap or lens can also be placed over the light-emitting endoscope to further highlight and identify the proposed intersection point. Similar techniques can use radio or ultrasound transducers and receivers to couple the endoscope tip. In some embodiments, the system can include an endoscope with a sensor and a magnetic anastomosis device for deployment using the endoscope.

[0055] A third positioning technique involves magnetic sensing to determine the proximity of deployed ring magnets in adjacent lumens. By maximizing the sensed magnetic field, the minimum distance between adjacent channels can be determined. The magnetic sensor is carried on a probe inserted into the working channel of the endoscope and can utilize common magnetic sensing technologies such as Hall-effect sensors or reed switches.

[0056] With magnetic sensing through illumination, additional accessories can also assist in delivering the magnetic device to the precise anastomosis site. A radially expanding ring structure can be deployed with an endoscope or laparoscope that can be press-fit and seated onto the outer diameter of the scope. The outer diameter of the expander element is sized to allow the deployed device to seat onto the expander element (again, likely a press fit). With the expander element and magnetic device radially seated around the endoscope shaft, the endoscope can be directed to the ideal anastomosis location by direct contact, illumination penetration, or magnetic sensing, followed by release of the mating magnetic device when the anastomosis site is identified.

[0057] In other embodiments, the self-assembling magnet devices can be delivered using ultrasound guidance, such as endoscopic ultrasound. For example, an intragastric echoendoscope can be used to identify a suitable small intestinal target. As shown in FIG. 6, a delivery needle 600 (e.g., an aspiration needle) or catheter can be used to access the small intestinal target and deliver the self-assembling magnets into the small intestinal lumen. Delivery can be guided by fluoroscopy or endoscopic ultrasound. Following self-assembly, these small intestinal magnets are combined with a second magnet set deployed within the stomach. The two devices can be delivered using the same needle or different needles. It is also possible to deliver the first device with an endoscope and the second device with a needle, or vice versa.

[0058] In another embodiment, shown in Figure 7, the first anastomosis created in the initial procedure can be used to provide access for the creation of a second anastomosis. This process could, in theory, be repeated multiple times to create additional anastomoses. For example, a gastrojejunostomy (stomach-to-mid-small intestine) could serve as a conduit for creating a second, more distal gastrojejunostomy. Ultimately, in this particular scenario, the stomach has several bypasses to the small intestine. Furthermore, in some cases, more anastomoses can be added for specific clinical effects (e.g., hypoglycosylated hemoglobin in type 2 diabetes), a "titration" approach. In an alternative embodiment, anastomoses may be placed to provide access for different types of surgery, such as tumor removal.

[0059] In another embodiment of delivery, self-assembling magnets can be delivered laparoscopically through a surgical incision into the target organ (e.g., the stomach and small intestine) and joined to form an anastomosis, as shown in Figure 8. Again, this procedure can be performed using fluoroscopy or ultrasound, and the procedure can be purely laparoscopic, or a combination of endoscopic and / or laparoscopic and / or needle procedures.

[0060] Gastrointestinal anastomoses can be used to address several conditions. An anastomosis or series of anastomoses between the proximal and distal intestines can be used to treat metabolic conditions such as obesity and type II diabetes and dyslipidemia. This procedure can also be used to induce weight loss and improve metabolic profiles, such as lipid profiles. The intestine includes any segment of the digestive tract extending from the pyloric sphincter of the stomach to the anus. In some embodiments, an anastomosis is created to bypass diseased, malformed, or dysfunctional tissue. In some embodiments, an anastomosis is created to alter the "normal" digestive process to reduce or prevent other diseases, such as diabetes, hypertension, autoimmune, or musculoskeletal disorders.

[0061] Using the self-assembling magnetic devices discussed herein, it is possible to create a side-to-side anastomosis that does not require removal of intermediate tissue, as is common in state-of-the-art bariatric procedures. That is, the devices of the present invention (or other means for creating an anastomosis) can be used to create an alternative pathway that partially bypasses fluids (e.g., gastric juices) and nutrients (e.g., food) while maintaining at least a portion of the old pathway. This design allows the ratio of "normal" to "modified" digestion to be adjusted based on the goals of the procedure. In other words, using the described procedure, the physician can select the ratio of food / fluid flowing through the new (partial) bypass to the old pathway. In most cases, the fraction shunted to the bypass limb will move the patient toward the desired clinical endpoint (e.g., weight loss, improved glycosylated hemoglobin, improved lipid profile, etc.). The mechanism by which this endpoint is achieved may involve, for example, early macronutrient delivery to the ileum accompanied by stimulation of L cells and increased GLP-1 production. This mechanism also involves a loss of efficiency in nutrient absorption, particularly of glucose, thereby reducing blood glucose levels. At the same time, however, the fraction diverging from the old pathway protects against known metabolic complications that may be associated with bariatric surgery, such as excessive weight loss, malabsorptive diarrhea, electrolyte disturbances, and malnutrition.

[0062] The size, location, and possibly number of anastomoses are important to achieve the desired bypass ratio (e.g., redirecting food and secretions through a new route, e.g., 70%, 80%, 90%, or 100% of the time). For example, in the case of gastrojejunostomies, it may be important to place the anastomoses subtly to take advantage of the effects of gravity. Also, instead of circular anastomoses, it may be better to create long, oval anastomoses to maximize anastomosis size. Alternatively, multiple gastrojejunostomies may 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 perform one or more anastomoses as needed to achieve the desired clinical endpoint. For example, the two endoscopic procedures shown in Figures 4A and 4B 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, the anastomoses shown in Figures 4A and 4B can be made larger, e.g., with an opening diameter of more than 1 cm, or several smaller anastomoses can be placed to achieve the desired ratio.

[0063] The procedure is also adjustable. For example, a first anastomosis can be created, and then, based on post-procedure clinical testing, one or more anastomoses can be added to improve clinical trial results. Based on subsequent clinical results, it may be necessary to add additional anastomoses. Alternatively, the condition can be partially reversed by closing one or more anastomoses. Because the partially bypassed tissue was not removed, the passage of larger amounts of nutrients and the like can return the patient to near-normal function. Anastomoses can be closed with clips, sutures, staples, and the like. In other embodiments, plugs can be placed in one or more anastomoses to limit the rate at which nutrients cross the "normal" pathway. Furthermore, it is possible to close an anastomosis at one location in the intestine and then place a new anastomosis at a different location. Thus, for example, as illustrated in Figure 3, it is possible to create a partial bypass or a series of partial bypasses between segments of the intestine globally and adjustably to achieve a clinical endpoint.

[0064] The described procedure can also be used in conjunction with procedures to remove or block bypassed tissue, as is common in bariatric procedures. For example, a gastrojejunostomy can be coupled with a pyloric plug (gastric closure) or another closure of the pylorus (e.g., suture closure) to completely shunt food into the new bypass. Such procedures can be used, for example, to bypass tissue affected by cancer.

[0065] In another category of procedures, endoscopic ultrasound (EUS) can be used to facilitate guided transgastric or transduodenal access to the gallbladder for placement of a self-assembling magnetic anastomosis device. Once gallbladder access is obtained, various strategies can be employed to maintain a patent portal vein between the stomach and gallbladder or between the duodenum and gallbladder. In another embodiment, gallstones can be endoscopically retrieved and fluids drained. For example, an anastomosis can be created between the gallbladder and stomach using the described methods. Once the gallbladder is accessed transgastric or transduodenal, gallstones can be removed. Additionally, the gallbladder mucosa can be resected using any number of modalities, including, but not limited to, argon plasma coagulation (APC), photodynamic therapy (PDT), and sclerosing agents (e.g., ethanolamine or ethanol).

[0066] One strategy for creating a portal vein is to deploy self-assembling magnets into the gallbladder and the stomach or duodenum through an endoscopic needle under ultrasound guidance. These magnets then interlock, forming a compression anastomosis or fistula. A second strategy for creating a portal is to deploy self-assembling magnets through an endoscopic needle 600, as shown in Figures 9A and 9B. While the combined magnetic assembly is shown as an octagon, the closed frame can take any polygonal shape, such as a square, circle, triangle, hexagon, heptagon, nonagon, decagon, or dodecagon. One such device is deployed in the gallbladder, and the mating device is deployed in the stomach or duodenum. In the same manner as described above for gastrointestinal deployment, the tissue surrounded by the two magnetic devices can be cut with a cautery, microscalpel, needle knife, or other deployable cutting mechanism. In another embodiment, the connected tissue can be necrotized to form an anastomosis.

[0067] However, the device need not be limited to forming holes. Other structures can be coupled to one or more mating magnetic devices to create additional functions. For example, as shown in Figure 10, a stent can be deployed between tissues such as the gallbladder and stomach. Alternatively, the gallbladder magnet can be coupled to a balloon-based device filled with air, fluid, magnetic particles, or magnetic particles. When inflated, the balloon acts as an anchor within the bile duct after placement. The balloon can also have an annular configuration for immediate access after coupling with a second magnet. See, for example, Figure 11. Regardless of the embodiment, however, it is important to include the original access route within the range of the coupled magnet, i.e., not leave a path for bile leakage. Otherwise, the opening could allow bile leakage, which could result in peritonitis.

[0068] Another medical application of self-assembling magnets is direct bile duct access. Currently, endoscopic retrograde cholangiopancreatography (ERCP) is performed to achieve decompression for malignant bile duct strictures. The bile duct is accessed endoscopically through the papilla in a retrograde manner, and a stent is deployed across the stricture over a guidewire. These stents often require subsequent procedures for exchange, removal, or placement of additional overlapping stents. When using ERCP procedures, the need for exchange and irrigation is necessary to combat the high rate of bile duct infection (i.e., cholangitis). Due to the high morbidity, ERCP is typically limited to patients with no other options for addressing pancreatic disease.

[0069] However, using the devices of the present invention, it is possible to easily create an anastomosis between the bile duct (preferably the main bile duct) and either the duodenum or stomach (choledocho-gastric anastomosis and choledocho-duodenal anastomosis, respectively). This anastomosis is permanent and, if located away from diseased tissue, typically 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-assembling magnetic device is pushed through a needle or catheter and then unfolds in the correct configuration. Fluoroscopy or ultrasound can then be used to confirm that the device has self-assembled and is in the correct position. In some embodiments, the magnetic device may be tethered to the delivery needle or catheter by a detachable wire or suture to allow mechanical retraction until optimal positioning is confirmed.

[0070] In one embodiment, the magnetic device can be delivered endoscopically to the bile duct through the duodenal wall, as shown in Figure 12. In another embodiment, as shown in Figure 13, the bile duct magnet can be delivered in a conventional retrograde manner through the ampulla into the bile duct. One advantage of retrograde delivery is that it avoids needle puncture across a tissue plane, as is the case with the deployment method shown in Figure 12. However, regardless of the method of delivering the bile duct magnet, a second magnetic device is required in either 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 location of the initial bile duct magnet. In an ultrasound-endoscopic needle delivery scenario, the second magnetic device can be connected to the bile duct magnet via the detachable wire described above and then pushed through the same delivery needle / catheter. Alternatively, the second device can be pre-attached to the exterior of the endoscope and slid into position for attachment after bile duct magnet deployment. While the latter procedure may be more applicable with forward-looking echoendoscopes, it can be used with endoscopes in general.

[0071] In another embodiment, the bile duct magnet is a balloon-based device filled with air, fluid, magnetic particles, or magnetic particles, similar to that described above for the gallbladder procedure. When inflated, the balloon acts as an anchor within the bile duct after placement. In one embodiment, the balloon can have an annular configuration for ready access after coupling with a second magnet. Furthermore, similar to the gallbladder procedure described above, the bile duct magnetic device can be used with a stent form factor. In one embodiment, the stent has an internal bile duct magnet and a hinged external magnet. The stent can be inserted retrogradely into the bile duct through the ampulla. The hinged external magnet can then be swung around and coupled to the internal bile duct magnet to form a fistula between the bile duct and the duodenum, as shown in Figure 15.

[0072] The magnetic device of the present invention can also be used to treat pancreatic diseases. For example, the pancreatic duct requires decompression in certain disease states, such as chronic pancreatitis. Currently, extensive pancreatic duct decompression requires surgery (e.g., the Peustow procedure, in which the pancreas is filled along the axis of the duct and connected to a loop of small intestine to improve pancreatic drainage). As an alternative to the Peustow procedure, extensive pancreatic duct decompression can be achieved by using a magnetic pancreatic catheter to create a large magnetic compression anastomosis between the pancreatic duct and either the stomach or duodenum, as shown in Figure 16. The catheter can be magnetic along its entire length or only at specific intervals. The catheter can be in the form of a stent or straw. The pancreatic duct can be accessed using conventional ERCP (retrograde cannulation through the ampulla) or by direct needle access using endoscopic ultrasound (EUS). The magnetic pancreatic catheter can be delivered into the pancreatic duct and coupled to a second magnetic device in either the stomach or duodenum. As in the biliary duct scenario described above, the magnetic pancreatic catheter can be hinged to the second magnetic device.

[0073] As shown in Figure 17, self-assembling magnetic devices can also be used to access and drain fluid collections located adjacent to the gastrointestinal tract. For example, after a bout of pancreatitis, a pancreatic fluid collection may form that requires drainage. Drainage can be achieved using surgery or a percutaneous catheter, but endoscopic drainage has proven more clinically and cost-effective, but can be complicated by bleeding, perforation, and / or inadequate drainage. As an alternative to surgical drainage, the magnetic devices of the present invention can be delivered into the collection through a needle or sharp catheter under endoscopic ultrasound (EUS) guidance, as shown in Figure 17. After assembly, a first magnetic device is coupled to a second magnetic device placed in the gastrointestinal lumen (e.g., stomach). To speed removal after drainage, the first magnet may be tethered by a connecting wire, as previously described. As previously described, intervening tissue can be severed using electrocautery or dilation followed by needle and wire access. Additional devices, such as a magnetic coupling clamp, can be used to control blood flow, allowing for "bloodless" endoscopy to enter the collection.

[0074] Self-assembling magnets can also be used in urological applications, such as forming a bypass to treat an obstructed urogenital tract, as shown in FIG. 18. For example, magnetic anastomoses can be created between the renal calyx and the intestine (A), between the ureter and the intestine (B), or between the bladder and the intestine (C). The self-assembling magnetic devices of the present invention can be delivered into the urinary tract using an endoscope, laparoscope, or needle, as described above. As previously described, the reciprocating magnetic device can be delivered into the gastrointestinal tract using an endoscope, laparoscope, or needle. In other embodiments, the devices can be used in reproductive procedures, such as bypassing a portion of an obstructed fallopian tube or bypassing a vasectomy.

[0075] In yet another application, the self-assembling magnetic device can be used to create vascular anastomoses or treat cardiac conditions. For example, as shown in FIG. 19, a magnetic anastomotic bond can be formed between adjacent blood vessels using the magnetic device. In one embodiment, the self-assembling device can be delivered with a vascular delivery device, such as a catheter. Additionally, as described above with respect to gallbladder and pancreatic applications, shunts can be placed to bypass weak or blocked portions of the vasculature.

[0076] Self-assembling magnets can also be used in pulmonary applications, such as creating a bypass in the airways to treat chronic obstructive pulmonary disease (COPD). For example, a magnetic anastomosis can be formed by deploying a self-assembling magnetic device to adjacent bronchioles, as shown in Figure 20. Creating a pulmonary "bypass" could potentially reduce the airway resistance that characterizes respiratory diseases such as COPD.

[0077] Self-assembling magnetic devices can also be used to form surgical stomas, for example, for redirecting fecal flow into a colostomy bag. For example, a magnetic anastomosis can be created by deploying self-assembling magnets within the digestive tract (e.g., the large intestine) and then coupling the internal magnet to an external magnet worn and secured at skin level, as shown in Figure 21. The external magnetic device may be coupled to a third magnetic device coupled to a collection device. Such a system allows for easy removal of the collection device for cleaning, etc.

[0078] While various embodiments of the present invention have been described and illustrated herein, those skilled in the art will readily envision numerous other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each such variation and / or modification is deemed to be within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the particular application or applications for which the teachings of the present invention are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Accordingly, the foregoing embodiments are presented by way of example only, and it should be understood that, within the scope of the appended claims and their equivalents, embodiments of the invention may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the inventive scope of the present disclosure, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0079] Various inventive concepts may be embodied as one or more methods, examples of which are provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, while shown as sequential actions in the exemplary embodiments, embodiments can be constructed in which actions are performed in a different order than illustrated, which may include performing some actions simultaneously.

[0080] All definitions defined and used herein should be understood to control for dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms. The indefinite articles "a" and "an," as used in the specification and claims, unless expressly indicated otherwise, should be understood to mean "at least one."

[0081] The term "and / or," as used in the specification and claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are present conjunctively in some cases and disjunctively in other cases. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the "and / or" clause, whether related or not to the elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with open-ended language such as "comprising," can, in one embodiment, refer to A only (optionally including elements other than B); in another embodiment, it can refer to B only (optionally including elements other than A); in yet another embodiment, it can refer to both A and B (optionally including other elements); and so on.

[0082] As used in this specification and the claims, "or" should 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" should be interpreted as inclusive, i.e., including at least one of a number or list of elements, but also including two or more, and optionally including additional unlisted items. Only terms clearly indicating the contrary, such as "only one of" or "exactly one of," or, when used in the claims, "consisting of," refer to the inclusion of exactly one element of several elements or a list of elements. In general, the term "or" as used herein, when used in the claims, when preceded by terms of exclusivity, such as "either," "one," "only one," or "exactly one of," "consisting essentially of," etc., shall be interpreted only as indicating exclusive alternatives (i.e., "one or the other, but not both") and shall have its ordinary meaning as used in the field of patent law.

[0083] As used in this specification and claims, the phrase "at least one" in reference 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 does not necessarily include at least one of each and every element specifically listed in the list of elements, nor does it exclude any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related to the specifically identified elements or not. 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 refer in one embodiment to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment to 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 forth.

[0084] As used in the specification and claims, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, shall be understood to be open-ended, i.e., to mean including, but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of," respectively, shall be closed or semi-closed transitional phrases as set forth in the United States Patent Office Manual of Patent Examining Procedures Section 2111.03.

[0085] Various embodiments of the present invention can be characterized by 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 specification of this application. Accordingly, the subject matter of the following potential claims may be presented as actual claims in a later proceeding, including this application or any application claiming priority from 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. Accordingly, a decision not to present these potential claims in a later proceeding should not be construed as a public offering of that subject matter. Additionally, these potential claims are not intended to limit the various claims that may be pursued.

[0086] Without limitation, potentially claimed subject matter (prefaced with the letter "P" to avoid confusion with the actual claims presented below) includes:

[0087] P1. An individual magnetic vertebral portion for a magnetic compression anastomosis device, the magnetic vertebral portion comprising: a vertebral skin comprising a metal alloy, a polymer, and / or a composite material; a flexible segment configured as a tension member; a spring-loaded flexible member configured to assist in the formation of an array; and a roller configured to provide radial constraint and limit degrees of freedom to stiffen the array from a torsional perspective.

[0088] P2. The vertebra of claim P1, further comprising rollers or nodes configured to generate rotation in one plane while restricting the opposite torsional degree of freedom by 90 degrees, and stops configured to restrict one or more degrees of freedom.

[0089] P3. The vertebra of claim P1, further comprising a male node of a first vertebra configured to couple with a female node of a second vertebra, said vertebrae shaped to provide an interference that allows a predetermined amount of rotation about an axis of said male node and said female node.

[0090] While the foregoing discussion discloses various exemplary embodiments of the present invention, it will be apparent to those skilled in the art that various modifications may be made which will achieve some of the advantages of the present invention without departing from the true scope of the invention. Any reference to the "invention" is intended to refer to exemplary embodiments of the invention and should not be construed as referring to all embodiments of the invention unless the context otherwise requires. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

Claims

1. 1. A magnetic compression anastomosis device comprising: a first multi-piece internal vertebral support structure including a first set of magnets attached to an exterior-facing side of the first multi-piece internal vertebral support structure; 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, the first and second multi-piece internal vertebral support structures being attached to one another in a sandwich configuration with the inward-facing side of the first multi-piece internal vertebral support structure facing the inward-facing side of the second multi-piece internal vertebral support structure and the magnets on the outward-facing side of the magnetic compression anastomosis device; 1. A magnetic compression anastomosis device comprising:

2. The device of claim 1 , wherein the first and second multi-piece internal vertebral support structures are attached to one another by welding.

3. The device of claim 1 , wherein the first and second multi-piece internal vertebral support structures are attached to one another by bonding.

4. The device of claim 1 , wherein the first and second multi-piece internal vertebral support structures are attached to one another by swaging.

5. The device of claim 1 , wherein the first and second multi-piece internal vertebral support structures are attached to one another by stamping.

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

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

8. The device of claim 1 , wherein the magnet is attached to the multi-piece internal vertebral support structure using an adhesive.

9. The device of claim 1 , wherein the magnet is attached to the multi-piece internal vertebral support structure using mechanical fasteners.

10. The device of claim 1 , wherein the magnet is attached to the multi-piece internal vertebral support structure using a clamp.

11. The device of claim 1 , wherein the magnet is attached to the multi-piece internal vertebral support structure using interlocking elements.

12. at least one flexible element that biases the multi-piece internal vertebral support structure toward an assembled configuration; The apparatus of claim 1 further comprising:

13. The device of claim 12 , wherein the assembled configuration is a circle.

14. The device of claim 13 , wherein the assembled configuration is a polygon.

15. 2. The device of claim 1, wherein each of the first and second multi-piece internal vertebral support structures includes a plurality of interconnected internal vertebral pieces having a male end opposite a female end, the opposing male and female ends configured to couple and join the pieces together.

16. 16. The device of claim 15, wherein the individual interconnected internal vertebral fragments are connected by bolts.

17. 16. The device of claim 15, wherein the individual interconnected internal vertebral pieces are connected by rivets.

18. 16. The device of claim 15, wherein the individual interconnected internal vertebral fragments are connected by fasteners.

19. 16. The device of claim 15, wherein the connections between the individual interconnected internal vertebral fragments are configured to allow axial rotation while also restricting torsional motion.

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

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