Magnetic compression anastomosis device with multi-piece vertebrae

Abstract

A magnetic compression anastomosis device includes a plurality of interconnected vertebrae including a first vertebra and a second vertebra, where each of the first and second vertebrae is a multi-piece vertebra including a magnet at least partially encapsulated by a vertebral skin, and where the magnet at least partially encloses the first and second vertebrae, and where the magnet at least partially encloses the first and second vertebrae. The first vertebra and the second vertebra are interconnected by a cylindrical roller and at least one flexible element, the roller and the at least one flexible element being at least partially encapsulated by the first vertebral skin and the second vertebral skin, the rollers are configured to allow the first and second vertebrae to pivot through a predetermined range of rotation in a device plane between at least a delivery configuration and an assembled configuration while constraining movement in other degrees of freedom, and the at least one flexible element biases the first and second vertebrae toward the assembled configuration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 395,570, filed on August 5, 2022, entitled SUPPORT FOR MAGNETIC SEGMENTS OF A MAGNETIC ANASTOMOSISDEVICE, the entire contents of which are 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 desired sites to improve the accuracy of anastomosis creation between tissues, organs or the like. Background Art

[0004] The bypass of gastrointestinal (GI), cardiovascular or urinary system is usually formed by cutting holes in tissue at two positions and joining holes with sutures or nails. Bypass is usually set to guide fluid (for example, blood, nutrients) between the healthier parts of the system, while bypassing the tissue of disease or dysfunction. This operation is usually invasive, and the patient is subjected to risks such as bleeding, infection, pain and adverse reactions to anesthesia. In addition, the bypass created with sutures or nails may become complicated due to postoperative leakage and adhesion. Leakage may cause infection or sepsis, and adhesion may cause complications such as intestinal strangulation and intestinal obstruction. Although traditional bypass surgery can be completed with endoscopes, laparoscopes or robots, it may be time-consuming to join the holes cut into the tissue. In addition, such an operation requires professional knowledge and a device that cannot be obtained in many surgical facilities.

[0005] As an alternative to sutures or staples, surgeons can use mechanical couplings or magnets to create compression anastomosis between tissues. For example, compression couplings or paired magnets can be delivered to tissue to be joined. Due to strong compression, the tissue bound between couplings or magnets is cut off from its blood supply. Under these conditions, tissue becomes necrotic and degenerates, and at the same time, new tissue grows around the compression point, such as growing on the edge of the coupling. Over time, the coupling can be removed, thereby leaving a healed anastomosis between tissues.

[0006] Nevertheless, the difficulty of setting up magnets or couplings limits the locations where compression anastomosis can be used. In most cases, the magnets or couplings must be delivered as two separate components, which requires an open surgical field or a bulky delivery device. For example, existing magnetic compression devices are limited to structures that are small enough to be deployed with a delivery catheter (e.g., an endoscopic instrument channel or a laparoscopic port). When these smaller structures are used, the anastomosis formed is small and has poor short-term patency. In addition, the placement of the magnets or couplings may be imprecise, which may result in the formation of an anastomosis in an undesirable or inaccurate location.

[0007] Therefore, there is still a clinical need for reliable devices and minimally invasive surgery to promote the formation of compressed anastomoses between human tissues. Summary of the invention

[0008] During deployment of a self-forming magnetic array, control of the individual magnetic pieces is critical. Constraining the degrees of freedom to a specific set of parameters provides durability as well as improved geometry control. When connecting two separate magnets, it is also important that the geometry is aligned to create a compression zone of sufficiently high pressure to cut off fluid exchange with surrounding tissue within the geometry created by the self-forming array.

[0009] Embodiments of the present invention utilize independent magnets connected by a multi-piece vertebral design. Previous innovations utilized a single formed alloy piece to create the support. The present invention utilizes separate flexible sections connected to a flexible skeleton, vertebral shells, and "rollers" or integrated "rolling nodes" to limit degrees of freedom during forming and increase durability.

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

[0011] More specifically, according to one embodiment of the present invention, a magnetic compression anastomosis device includes a plurality of interconnected vertebrae, the plurality of interconnected vertebrae including a first vertebra and a second vertebra, wherein each of the first vertebra and the second vertebra is a multi-piece vertebra including a magnet at least partially encapsulated by a vertebral skin, and wherein the first vertebra and the second vertebra are interconnected by a cylindrical roller and at least one flexible element, the roller and the at least one flexible element being at least partially encapsulated by the first vertebra skin and the second vertebra skin. The roller is configured to allow the first vertebra and the second vertebra to pivot through a predetermined rotational range in the plane of the device between at least a delivery configuration and an assembled configuration while constraining movement in other degrees of freedom, and the at least one flexible element biases the first and second vertebrae toward the assembled configuration.

[0012] In various alternative embodiments, the vertebral skin may include at least one of a metal alloy, a polymer or a composite material, such as a shape memory material. The vertebral skin may be constructed with various types of features, such as at least one tissue cutting element, at least one tissue compression element and / or a tissue fixation element. Each vertebral skin may include a male node and a female node at opposite ends of the vertebral skin, in which case the male node may be configured to fix the roller in place. The roller may be, for example, a hollow cylinder or a solid cylinder. The flexible element may include a flexible rod (e.g., including a spring mechanism such as a shape memory material) or a U-shaped frame pair operatively coupled to the roller. In some embodiments, the roller and the flexible element may be implemented using a coil spring or a torsion spring. The vertebrae may be aligned in a substantially straight structure in the transport configuration and / or may be arranged in a circular or polygonal structure in the assembly configuration. The vertebrae may include a proximal vertebra and a distal vertebra, and the proximal vertebra and the distal vertebra are magnetically coupled to each other in the assembly configuration.

[0013] According to another embodiment of the present invention, a magnetic compression anastomosis system includes a delivery device, which includes a lumen and at least one magnetic compression anastomosis device as described above, wherein the at least one magnetic compression anastomosis device is pre-set in the lumen of the delivery device in a delivery configuration.

[0014] Additional embodiments may be disclosed and claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Those skilled in the art will more fully appreciate the advantages of the various embodiments of the present invention from the following "Detailed Description," which is discussed with reference to the accompanying drawings summarized immediately below.

[0016] Figure 1 A magnet assembly is shown being delivered through an endoscope instrument channel, causing the individual magnets to self-assemble into a larger magnetic structure, in this particular case an octagon.

[0017] Figure 2A The magnet assembly is shown having been delivered and deployed to adjacent tissue.

[0018] Figure 2B Two magnet assemblies are shown coupled together by magnetic attraction, entrapping intervening tissue. In some cases, an endoscope can be used to cut through enclosed tissue.

[0019] Figure 3 Several potential anatomical targets for anastomosis formation are shown: arrow A is stomach to small intestine, arrow B is small intestine to large intestine, arrow C is small intestine to small intestine, arrow D is large intestine to large intestine, and arrow E is stomach to large intestine.

[0020] Figure 4AOne embodiment of delivery of the magnet assembly is shown using two endoscopes (a colonoscope and an enteroscope or gastroscope).

[0021] Figure 4B Another embodiment is shown for delivery using two upper endoscopes that share a transoral access port for delivery of the magnet assembly.

[0022] Figure 5 Another embodiment of the delivery of magnet assemblies sequentially using a single endoscope is shown.

[0023] Figure 6 Another embodiment of delivery is shown using an endoscopic ultrasound guided needle to deliver one magnet assembly into cavity #1 and then deploy a second magnet assembly into cavity #2.

[0024] Figure 7 The creation of a preliminary anastomosis is shown, which serves as a conduit for deeper endoscopic delivery to create subsequent multiple anastomoses.

[0025] Figure 8 Laparoscopic magnet device delivery into a lumen, in this example the stomach, is shown.

[0026] Fig.9A The endoscopic ultrasound-guided needle delivers the magnet assembly into the gallbladder and then Fig. 9B The magnet assembly is shown coupled to a second magnet assembly in the stomach or duodenum.

[0027] Fig.10 Deployment of a stent between the gallbladder and the stomach or duodenum is shown.

[0028] Fig.11 Another embodiment of an intra-gallbladder magnet assembly is shown, which is a balloon filled with fluid, gas, or magnetic material. The balloon is tethered to an endoscope and initially delivered through an endoscopic ultrasound-guided needle.

[0029] Fig.12 Endoscopic ultrasound-guided needle delivery of a magnet assembly into the bile duct is shown.

[0030] Fig.13 Delivery of a magnet assembly into the bile duct via endoscopic retrograde cholangiopancreatography is shown.

[0031] Fig.14 The coupling of the intra-biliary magnet assembly to a second magnet assembly deployed in the stomach A or the duodenum B is shown.

[0032] Fig.15Another embodiment of a bile duct magnetic anastomosis is shown, in which a linked magnetic bile duct stent is swung back onto itself by magnetic attraction to form an anastomosis between the bile duct and the duodenum.

[0033] Fig.16 A magnetic stent that can be delivered into the pancreatic duct is shown. The stent can be coupled with magnets in the stomach A or duodenum B to create a draining anastomosis for the pancreatic duct.

[0034] Fig.17 A magnetic assembly is shown being delivered via an endoscopic ultrasound-guided needle / tube into the fluid collection surrounding the pancreas (dashed structure) and then connected to a second magnet assembly deployed in the stomach.

[0035] Fig.18 Different targets of anastomosis between the urinary and gastrointestinal systems are shown: renal calyces A, ureters B, and bladder C.

[0036] Fig.19 An assembly of magnets in adjacent blood vessels is shown to couple and create a vascular anastomosis.

[0037] Fig. 20 The magnet assembly in different parts of the respiratory system is shown to create an anastomosis between adjacent bronchioles.

[0038] Fig.21 Shown are an external magnet assembly and an internal magnet assembly within the gastrointestinal tract to create a surgical stoma for fecal drainage.

[0039] Fig. 22 An exploded view of a multi-piece vertebra depicting a self-assembling magnetic compression stapling device in accordance with certain embodiments.

[0040] Fig.23 yes Fig. 22 0014] The EMBODIMENT 1 is an enlarged view of the various components shown in , and also shows examples of flexible elements according to certain embodiments.

[0041] Fig.24 Alternative examples of flexible elements according to certain embodiments are shown.

[0042] Fig.25 Outlines of various geometries of magnetic segments according to certain embodiments are shown.

[0043] Fig.26 An example of a roller in the form of a torsion spring is shown in accordance with certain embodiments.

[0044] It should be noted that the aforementioned figures and the elements depicted therein are not necessarily drawn to consistent scale or any ratio. Unless the context otherwise requires, the same elements are represented by the same numbers. The drawings are primarily for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. DETAILED DESCRIPTION

[0045] Exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses in the body, such as the gastrointestinal tract. Such devices and techniques facilitate faster and cheaper 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, such as gastric or colon cancer.

[0046] The system generally includes an access device, which is configured to be disposed in a patient's hollow body and facilitate the formation of an anastomosis at a target site (desired anatomical location) in the hollow body, for forming an anastomosis between a first tissue portion of the hollow body at the target site and a second tissue portion 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 tissue portion of the hollow body and further deliver and position a first implantable magnetic anastomosis device. For example, the second implantable magnetic anastomosis device is delivered to an adjacent hollow body using the same access device or the second access device. The first implantable magnetic anastomosis device and the second implantable magnetic anastomosis device are configured to be magnetically attracted to each other through a defined tissue area having a combined thickness of the tissue wall at the target site, and to apply a compressive force on the defined area to form the anastomosis.

[0047] The systems, devices, and methods described herein include, but are not limited to, various access devices for accessing a patient's hollow body (e.g., a gallbladder) and fixing the positioning of an access device for subsequent placement of one of the magnetic stapling compression device pairs. The systems, devices, and methods described herein further include various delivery devices for delivering at least one of the magnetic stapling compression device pairs to a target site, wherein, in some instances, a delivery device consistent with the present disclosure can assist in the deployment of at least one of the pair of magnetic stapling compression devices and subsequently fixate to the target site and / or couple the magnetic stapling compression device pairs to each other. The systems, devices, and methods described herein include various embodiments of magnetic stapling compression devices and various designs for transitioning from a compact delivery configuration to a larger deployment configuration, typically through a self-assembly design.

[0048] 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 a minimally invasive technique to bridge the tissue walls of each organ together to form a passage (i.e., anastomosis) therebetween. The delivery device is particularly suitable for delivering the pair of magnetic components to a target site within the gastrointestinal tract to form an anastomosis between the stomach wall and the gallbladder wall to provide adequate drainage from the gallbladder when obstruction occurs (due to disease or other health-related issues).

[0049] Thus, exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses in the body, such as the gastrointestinal tract. Such devices and techniques facilitate faster and cheaper 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, such as gastric or colon cancer.

[0050] In endoscopic surgery, for example, a single endoscope can be used to deliver a self-assembling magnetic device. An exemplary magnetic anastomosis device can be delivered through an endoscope so that each magnet segment self-assembles into a larger magnetic structure. When used with the technology described herein, if the device is deployed as a complete assembly, the device allows the delivery of a magnetic structure larger than that which may be delivered via a small delivery catheter (such as in a standard endoscope). The larger magnet structure in turn allows the creation of a stronger larger anastomosis and achieves 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 a larger aspect ratio (i.e., a larger anastomosis is formed relative to the size of the magnetic assembly). In particular, prior art systems and methods including the use of magnets to create anastomosis are generally limited based on the size of the working channel of the mirror or catheter used to deliver such a magnet, which in turn limits the final size of the anastomosis. However, the magnetic assembly design of the exemplary embodiment overcomes such limitations. For example, the design of the magnetic assembly, particularly the coupling of multiple magnetic segments to each other via supports, allows any number of segments to be included in a single assembly, and thus the resulting anastomosis to have larger dimensions relative to the dimensions of the working channel of the endoscope. For example, in some embodiments, the resulting anastomosis can include an aspect ratio in the range of 2:1 to 10:1 or more.

[0051] Magnetic stapling devices generally include magnetic segments that can obtain a delivery configuration and a deployment configuration. The delivery configuration is generally linear, so that the device can be delivered to the tissue via a laparoscopic "keyhole" incision, or delivered via a natural path (e.g., via the esophagus) by an endoscope or similar device. In addition, the delivery structure is generally slightly flexible, so that the device can be guided through various curves in the body. Once the device is delivered, the device will automatically obtain a deployment configuration of the desired shape and size by automatically converting from the delivery configuration to the deployment configuration. The self-conversion from the delivery configuration to the deployment configuration is guided by a coupling structure that enables the magnetic segment to move in a desired manner without intervention. Exemplary self-assembling magnetic stapling 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, and the contents of each of these patents are incorporated herein by reference in their entirety.

[0052] During deployment of a self-forming magnetic array, control of the individual magnetic pieces is critical. Constraining the degrees of freedom to a specific set of parameters provides durability as well as improved geometry control. When connecting two separate magnets, it is also important that the geometry is aligned to create a compression zone of sufficiently high pressure to cut off fluid exchange with surrounding tissue within the geometry created by the self-forming array.

[0053] In such Fig. 22 In certain embodiments schematically depicted in , the magnetic compression anastomosis device 100 includes a plurality of magnetic segments 101 (three magnetic segments 101 of the eight magnetic segments 101 of this embodiment are labeled, but it should be noted that the embodiments are 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.

[0054] The vertebrae 101 are configured to allow movement between a delivery configuration of the device 100 (which is typically a substantially straight alignment of the vertebrae 101 to fit 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 limiting undesirable degrees of freedom, such as torsion, over-rotation, under-rotation, and out-of-plane deflection of one or more vertebrae, which may result in incomplete or non-assembly of the device 100. Thus, embodiments of the device 100 may be self-assembling devices (e.g., automatically and autonomously transforming to a fully assembled configuration upon delivery), although embodiments may additionally or alternatively include additional elements to assist or manually place the device 100 into a fully assembled form (e.g., sutures, threads, etc.). For purposes of this discussion, the plane of the device 100 may be considered to be a plane passing through the center of the vertebrae when in the fully assembled configuration. Vertebrae 1010 include proximal and distal vertebrae that are magnetically coupled to one another in an assembled configuration to form a circular or polygonal arrangement.

[0055] As discussed in more detail below, in certain embodiments, each vertebra 101 can be a multi-piece vertebra including a vertebral 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, for example, all vertebrae 101 having the same magnetic polarity, vertebrae 101 having alternating magnetic polarity, vertebrae 101 having alternating magnetic polarity pairs, vertebrae 101, etc. The present invention is not limited to any particular magnetic polarity configuration.

[0056] Each pair of adjacent interconnected vertebrae 101 is rotatably connected by a cylindrical roller 104. For the purpose of this discussion, the cylindrical roller is generally a hollow cylinder (e.g., tubular), although it can be a solid cylinder in some embodiments. The roller 104 can be used to provide radial constraints and limit the degree of freedom, thereby strengthening the assembly from the perspective of torsion. The roller 104 can be composed of a metal alloy, a polymer and / or a composite material. The roller 104 is preferably configured to allow the vertebrae 101 to rotate in the plane of the device, but to limit other degrees of freedom in other ways. The roller 104 may include features such as protrusions or grooves to help fix the roller 104 between the two vertebrae 101 and / or control the amount of rotation that may occur between the two vertebrae 101, for example, to provide radial constraints and limit the degree of freedom, thereby strengthening the assembly from the perspective of torsion. The roller 104 can be composed of any suitable material, such as a metal alloy, a polymer and / or a composite material. The roller 104 can be a separate component suitable for fitting between two or more magnets 103. Each magnet 103 may include a notch at each end adapted to engage a roller, thereby allowing movement in one plane while restricting movement in a 90 degree opposing plane.

[0057] Each pair of adjacent interconnected vertebrae 101 also typically includes a flexible element 106 (an example of which is shown in FIG. Fig.23 ), which helps move the vertebra 101 from the delivery configuration to the assembly 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 apply a bias toward the assembly configuration so that the vertebra 101 is biased toward the assembly configuration when the delivery device 100 is in place. The flexible element 106 can be made 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 the skins of two vertebrae on the outer periphery of the array. However, it should be noted that the flexible segment can also be positioned on the inner periphery 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 assist in the deployment of the array into an appropriate assembly geometry.

[0058] The vertebral skin 102 can be formed of suitable materials such as metal alloys, polymers and / or composite materials, and in particular can be formed of or include shape memory materials. The vertebral skin 102 encapsulates the magnet 103 and helps to fix the roller 104 and the flexible element 106 in the device 100, forming a protective layer while also limiting the degree of freedom. The vertebral skin 102 can be fixed to the magnet 103, with or without additional fasteners such as screws, pins, adhesives, interlocking elements, etc. Therefore, for example, by positioning the magnet 103, roller 104 and flexible element 106 for assembly, the vertebral skin 102 can be installed on the magnet 103, roller 104 and flexible element 106 to encapsulate these components. As shown, the vertebral skin 102 can be combined with male nodes 108 and female nodes 110 that can interact with the opposite sex nodes on another vertebra at the opposite ends of the vertebra. The male node 108 of one section is engaged or connected with the female node 110 of another section. The incorporated nodes support movement in one plane while limiting other degrees of freedom. The male node 108 can help secure the rollers 104 and / or the flexible element 106 within the device 100. The incorporated nodes can include stops to limit additional degrees of freedom, for example, to prevent "bending back" or excessive "bending forward" of the array, as shown in Figure 112. The stops can provide interference of the vertebrae while allowing a specified amount of rotation about the axis of interaction of the male and female nodes.

[0059] Fig.23 yes Fig. 22 1 and also shows an example of a flexible element 106 in which the flexible element 106 is in the form of a rod having a central spring portion (e.g., formed of a shape memory material). Without limitation, the flexible element 106 may be configured to fit within the channel 114 of the magnet 103 or 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 toward an assembled configuration. Embodiments may include one, two, or more flexible elements 106 and associated elements, such as elements 105 and 114, such as flexible elements 106 disposed on both sides of the vertebra 101. The flexible element 106 may be a unitary device or may include multiple components.

[0060] Fig.24 An alternative example of the flexible element 106 is shown, in which the flexible element 106 includes two oppositely oriented U-shaped frames, as shown in Figure 116, and the U-shaped frames are connected with the rollers 104 and the magnets 103 in a manner similar to that described above with reference to Fig.23The flexible element 106 shown and described operates as a bias spring. Specifically, a U-shaped frame can be set at each end of the magnetic segment. The U-shaped frame holds the roller 104 in place while allowing rotation in one plane but limiting out-of-plane movement. The U-shaped frame can be made of any suitable material, such as a metal alloy, a polymer and / or a composite material, and can be formed of or include a shape memory material in particular. The U-shaped frame allows movement in a plane while limiting torsional movement and movement in 90-degree relative planes. The roller and the U-shaped frame can be directly assembled on the magnetic segment, and within the vertebral skin, for example, the U-shaped frame can be assembled through the roller 104 and fixed by the roller 104, as shown in Figure 116, and extends along the length of the magnetic segment, such as in the channel 114. The roller 104 can include a flexible element support to fix the U-shaped frame in a position that allows biasing toward the assembly configuration. By interlocking the rollers 104 with the magnets 103, the rollers 104 and U-shaped frame 106 serve to provide structure and shape to the array while also reinforcing and preventing torsional motion in the array. This allows for more control over the final placement of the magnetic compression stapling device and prevents the formation of undesirable geometries.

[0061] Various geometries of various profiles of magnetic arrays are possible for the vertebrae 101 of the present invention, such as Fig.25 As shown. For example, the vertebral skin 102 can include smooth and / or patterned features and can be configured with different external geometries to achieve different anastomotic goals. For example, geometry (a) has concave sides, geometry (b) has convex sides with notches, geometry (c) has sharp side protrusions that can help cut tissue, and geometry (d) has flat sides that can compress and cause necrosis of a larger area of ​​tissue. The vertebra 101 can include other features, such as various types of protrusions or depressions, for example, to help secure the device 100 to the tissue. All vertebrae can use the same geometry, or different vertebrae can use different geometries.

[0062] It should be noted that while in the above described embodiment the flexible element 106 is encapsulated beneath the vertebral skin, alternative embodiments may place the flexible element 106 on the outside of the vertebral skin.

[0063] It should be noted that although two exemplary flexible elements 106 are shown and described herein, the present invention is not limited to these or any particular flexible elements. 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 be used as both a roller and a flexible element, e.g., Fig.26 Schematically depicted in .

[0064] It should be noted that in certain embodiments, device 100 can be disposed within a delivery device such as a catheter, endoscope, laparoscope, trocar, needle, or other delivery device, and thus the delivery device combined with device 100 can be considered an embodiment of the present invention.

[0065] Embodiments may also include methods of manufacturing the device 100, such as by providing various components (e.g., magnets, rollers, a flexible element, and vertebral skin), positioning the roller and the flexible element between two magnets and securing them as desired (e.g., securing the flexible element within a magnet channel), and placing the vertebral skin on the magnets, rollers, and the flexible element.

[0066] It should be noted that the kit can be provided with magnets, rollers, flexible elements and different types of vertebral skins having different configurations that can be used for different types of anastomotic procedures, such that different devices 100 can be prepared, for example, depending on the amount and type of pressure required for the particular procedure, the location of the procedure and the size of the anastomosis to be formed.

[0067] It should be noted that self-assembling magnetic anastomosis addresses several historical shortcomings of traditional anastomosis, such as being able to achieve surgical quality anastomoses in a minimally invasive manner while using a device with a large magnetic structure that can be repeatedly assembled into a predetermined shape in vivo. The constraints imposed by the described embodiments are intended to allow the device to consistently self-assemble into the correct shape after deployment, thereby greatly reducing the risk of surgical complications due to deformation or premature dislodgement of the device, while also reducing risks associated with surgical access, ensuring that the anastomosis forms an anastomosis with the correct geometric features. Overall, this ensures the patency of the anastomosis.

[0068] Thus, as described herein, embodiments include a flexible linear magnetic device comprising linked magnetic multipolar segments that self-assemble to form a rigid multipolar polygonal ring magnet (PRM; generally a "magnetic device") when extruded from the end of a deployment channel or lumen. The self-assembly is guided by the construction of magnets, rollers, flexible elements, and vertebral skin, which are capable of returning to a predetermined shape. In general, the physical and magnetic structure of the deployed magnetic device is such that when two magnetic devices are brought into proximity with each other, there is a rapidly increasing attractive magnetic interaction that creates a connection between the magnetic devices. In some cases, pre-alignment of the complementary devices is required, however, in other cases, the devices self-align by undergoing rapid in-plane rotations relative to each other, as discussed in detail below. As described in detail below, a system including a magnetic device can include an endoscope having a sensor that allows the endoscope to sense the position of a mating magnetic device or another endoscope that will deploy a mating device.

[0069] 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 be formed without further intervention. When the paired devices are set individually, the compressive force on the tissue collapses the vasculature and squeezes out the fluid in 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 the formed anastomosis. This cascade begins when the devices approach a "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 the movement of the tissue under normal physiological function.

[0070] In general, the design specifications of the device depend on the patient and the intended anastomosis. The design specifications can include: the desired capture range, the desired effective inner and outer diameters of the deployed polygonal ring (e.g., defined by the desired anastomotic size and instrument channel), the thickness of the target tissue, and the inner diameter and minimum radius of curvature of the guide channel, to 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 can be determined, such as the number and length of polygon sides, and the maximum lateral dimensions of the flexible linear magnetic structure to be deployed by the delivery device.

[0071] The deployment of the device 100 is generally Figure 1 . When used with the techniques described herein, if the device is deployed as a complete assembly, the device allows for the delivery of larger magnetic structures than those that could be delivered via a small delivery catheter (such as in a standard endoscope). Larger magnet structures, in turn, allow for the creation of stronger, larger anastomoses and greater surgical success. Because magnetic devices are typically radiopaque and echogenic, fluoroscopy, direct visualization (transmitted illumination or tissue indentation), and ultrasound (e.g., endoscopic ultrasound) can typically be used to locate the device. The device can also be decorated with radiopaque paint or other markers to help identify the polarity of the device during setup. In some embodiments, the device can be positioned using a sensor located near the delivery lumen and capable of sensing the position of the mating device, such as a reed switch or a Hall effect sensor.

[0072] Usually, if Figure 2A As shown, magnetic anastomosis procedures involve placing a first magnetic structure and a second magnetic structure near target tissue to bring the tissue together. The magnetic devices are typically deployed so that the opposite poles of the magnets will attract the tissue and bring the tissue together. Both devices can be deployed inside the body, or one can be deployed inside the body and the other outside the body. Once the magnets have been deployed, the tissue surrounded by the magnetic structures can be cut to provide an immediate anastomosis, such as Figure 2BAs shown. In other embodiments, the tissue surrounded by the device will be allowed to necrotize and degrade, thereby providing an opening between the tissues. Although the drawings and structures of the present disclosure are mainly related to circular or polygonal structures, it should be understood that the delivery and construction techniques described herein can be used to manufacture various deployable magnetic structures. For example, the self-assembled magnets can be reassembled into polygonal structures, such as circles, ellipses, squares, hexagons, octagons, decagons, or other geometric structures that produce closed loops. As needed, the device may additionally include handles, suture loops, barbs, and protrusions to achieve the desired performance and make delivery (and removal) easier.

[0073] As described with respect to the accompanying drawings, the self-assembling magnetic anastomosis device can be set up with 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 that the magnet is connected, the process for forming the anastomosis can be terminated without perforating the tissue. As previously described, the compression anastomosis process can be allowed to proceed in the following days, resulting in the natural formation of an opening between the tissues. The fused magnets can be allowed to be discharged naturally, or the magnets can be retrieved in subsequent surgical operations. Alternatively, if an immediate bypass is required, the tissue surrounded by the magnet can be cut or perforated. Perforation can be completed with a variety of techniques, such as cauterization, microscalpels, or balloon dilatation of the tissue after the needle and guide wire enter.

[0074] 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 obesity, or even to treat diabetes and metabolic diseases (i.e., metabolic surgery). Such a bypass can be created endoscopically, laparoscopically, or a combination of both. Figure 3 Various gastrointestinal anastomotic targets that can be addressed with the device of the present invention are illustrated; 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 an endoscopic procedure, two simultaneous endoscopes (e.g., an upper endoscope or enteroscope residing in the upper small intestine, and a colonoscope residing in the lower small intestine) can be used to deliver a self-assembling magnetic device, such as Figure 4A Alternatively, Figure 4B As shown, the device can be deployed using two simultaneous upper endoscopes (e.g., one in the stomach and the second in the small intestine). In other embodiments, the self-assembling magnets can be delivered sequentially through the same endoscope that has been moved between the first deployment position and the second deployment position. For example, in Figure 4A In this study, a single transoral endoscope can deliver and deploy a self-assembling magnet in the small intestine, withdraw, and then deploy a second reciprocal magnet in the stomach. Again, fluoroscopy can be used to confirm magnet coupling. Figure 5Removal of a single endoscope after setting up the two magnetic devices is illustrated.

[0075] Various techniques can be used to detect the first deployed magnetic device to assist in the setting of the second matching structure. Once the first device is deployed at the desired anastomotic position, the two deployed magnetic devices need to find each other's magnetic fields so that they can cooperate and provide the compression force required to promote the formation of the anastomotic portion. Ideally, the devices can be roughly positioned within a few centimeters of each other (for example, using ultrasound), at which time the magnets should be self-captured and self-aligned. In the event that 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, the displacement of the endoscope in the adjacent lumen produces a displacement seen by another endoscope in the adjacent lumen. The displacement identifies the potential intersection of the anastomotic position. For example, a magnetic deployment tool (described below) will be deflected due to the presence of the deployed device on the other side of the tissue wall.

[0076] A second positioning technique involves transillumination, whereby high-intensity light from one endoscope is directed to the lumen wall at the proposed anastomotic 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. The light indicates a potential intersection anastomosis point. A cover or lens may also be placed on the lighted endoscope to further enhance and precisely locate the proposed intersection. Similar techniques may use radio waves or ultrasonic transducers and receivers to juxtapose the endoscope tip. In some embodiments, the system may include an endoscope with a sensor and a magnetic anastomosis device for deployment using an endoscope.

[0077] The third positioning technique involves magnetic sensing technology 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 identified. The magnetic sensor can be carried on a probe inserted down the working channel of the endoscope and utilizes common magnetic sensing technology such as Hall effect sensors or reed switches.

[0078] Additional accessories can also help deliver the magnetic device to the precise anastomotic site using transmitted illumination and magnetic sensing. A radially expanding annular structure can be deployed with an endoscope or laparoscope that can be press-fit and position itself on the outer diameter of the scope. The outer diameter of the expansion element is sized to allow the deployed device to position itself on the expansion element (again, a press fit is possible). Using this expansion element and magnetic device radially arranged around the axis of the endoscope, the endoscope can be guided to the desired anastomotic location by direct contact, transmitted illumination, or magnetic sensing, and then the mating magnetic device is released when the anastomotic site is identified.

[0079] 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, a suitable small intestine target can be identified. Figure 6 As 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-assembled magnets into the small intestine lumen. Delivery can be guided by fluoroscopy or endoscopic ultrasound. After self-assembly, these small intestine magnets will be connected to a second set of magnets deployed in the stomach. The two devices can be delivered with the same needle or different needles. It is also possible to deliver the first device endoscopically and the second device with a needle, or vice versa.

[0080] In another embodiment, Figure 7 As illustrated, the first anastomosis formed in the initial surgery can be used to provide access for forming a second anastomosis. This process can theoretically be repeated multiple times to create additional anastomoses. For example, a gastrojejunal anastomosis (stomach to mid-small intestine) can be used as a conduit for forming a second, more distal gastrojejunal anastomosis. Ultimately, in this particular case, the stomach will have multiple bypasses to the small intestine. Additionally, in some cases, more anastomoses can be added to "titrate" a specific clinical effect (e.g., reducing glycosylated hemoglobin in patients with type 2 diabetes). In alternative embodiments, anastomoses can be provided to provide access to different types of surgeries (e.g., tumor removal).

[0081] In another embodiment of delivery, the self-assembling magnets can be delivered laparoscopically through a surgical incision into a target organ (e.g., stomach and small intestine) and allowed to connect to form an anastomosis, such as Figure 8 Likewise, the procedure can be guided with fluoroscopy or ultrasound, and the procedure can be purely laparoscopic, or a combination of endoscopy and / or laparoscopy and / or needle examination.

[0082] Gastrointestinal anastomosis can be used to address many conditions. An anastomosis or a series of anastomoses between the proximal intestine and the distal intestine can be used to treat obesity and metabolic conditions, such as type II diabetes and dyslipidemia. The method can also be used to induce weight loss and improve metabolic profiles, such as lipid profiles. The intestine includes any section of the digestive tract extending from the pyloric sphincter of the stomach to the anus. In some embodiments, an anastomosis is formed to bypass diseased, deformed, or dysfunctional tissue. In some embodiments, an anastomosis is formed to alter the "normal" digestive process in an effort to reduce or prevent other diseases, such as diabetes, hypertension, autoimmune or musculoskeletal diseases.

[0083] Using a self-assembling magnetic device as discussed herein, a side-to-side anastomosis can be created without the need to exclude intermediate tissue as is common in modern obesity surgery. That is, using the device of the present invention (or other devices for forming anastomosis), an alternative path can be created, which is a partial bypass for fluids (e.g., gastric juice) and nutrients (e.g., food) while maintaining at least a portion of the old path. This design allows the ratio of "normal" digestion to "modified" digestion to be adjusted based on the goals of the operation. In other words, using the described process, the doctor can choose the ratio of food / fluid shunted along the new (partial) bypass to food / fluid shunted along the old path. In most cases, the portion shunted to the bypass branch will drive the patient to the desired clinical endpoint (e.g., weight loss, improved glycated hemoglobin, improved lipid profile, etc.). The mechanism for achieving the endpoint may involve early delivery of a large amount of nutrients to the ileum, such as stimulating L cells and increasing GLP-1 production. The mechanism may also involve the loss of nutrient (especially glucose) absorption efficiency, thereby reducing blood sugar levels. However, at the same time, the portion shunted along the old pathway protects against known metabolic complications that may be associated with bariatric surgery, such as excessive weight loss, malabsorptive diarrhea, electrolyte disturbances, malnutrition, etc.

[0084] In order to achieve a desired bypass ratio (e.g., rerouting food and secretions to flow down a new path, e.g., 70% or 80% or 90% or 100% of the time), the size, location, and possibly number of anastomoses will be important. For example, with a gastrojejunal anastomosis, it may be critical to set the anastomosis in a gravity-dependent manner to take advantage of the effects of gravity. Also, instead of a circular anastomosis, it may be desirable to form a long, oval anastomosis to maximize the size of the anastomosis. Alternatively, multiple gastrojejunal anastomoses may be used to titrate to a certain clinical endpoint (e.g., glycosylated hemoglobin in type II diabetes). Most of the procedures described herein can be used to set one or more anastomoses as needed to achieve the desired clinical endpoint. For example, Figure 4A and Figure 4B The two endoscopic procedures shown in can be used to create a partial bypass of a portion of the intestine. Based on the desired ratio of bypassed and non-bypassed nutrients, Figure 4A and Figure 4B The anastomosis shown in can be made larger, for example, with an opening diameter greater than 1 cm, or several smaller anastomoses can be provided to achieve the desired ratio.

[0085] The process is also adjustable. For example, a first anastomosis may be formed, and then based on clinical testing performed after the procedure, one or more anastomoses may be added to improve the results of the clinical testing. Based on later clinical results, it may be necessary to add another anastomosis. Alternatively, the condition may be partially reversed by closing one or more anastomoses. Because the partially bypassed tissues are not removed, they can return to near normal function as greater amounts of nutrients, etc., pass through. The anastomoses may be closed with clips, sutures, staples, etc. In other embodiments, a plug may be placed in one or more anastomoses to limit the rate of nutrients that pass through the "normal" path. In addition, an anastomosis may be closed at one location in the intestine and then a new anastomosis may be placed at a different location. Thus, a partial bypass or a series of partial bypasses may be created generally and adjustably between portions of the intestine to achieve a clinical endpoint, such as, for example, Figure 3 Described in .

[0086] The described process can also be used in conjunction with a procedure to remove or block the bypassed tissue, as is common in bariatric procedures. For example, a gastrojejunostomy can be coupled with a pyloric plug (gastric obstruction) or another closure of the pylorus (e.g., suture closure) to completely shunt food to the new bypass. Such procedures can be used, for example, to bypass tissue that is diseased, such as due to cancer.

[0087] In another type of process, endoscopic ultrasound (EUS) can be used to facilitate guidance into the gallbladder through the stomach or through the duodenum to set up a self-assembled magnetic anastomosis device. Once the gallbladder access is obtained, various strategies can be used to maintain an open entrance between the stomach and gallbladder or the duodenum and gallbladder. In another embodiment, the gallstones can be removed and the fluid discharged through the endoscope. For example, using the described method, an anastomosis can be created between the gallbladder and the stomach. Once the gallbladder is accessed through the stomach or through the duodenum, the gallstones can be removed. In addition, any number of methods can be used to ablate the gallbladder mucosa, including but not limited to argon plasma coagulation (APC), photodynamic therapy (PDT), sclerosants (e.g., ethanolamine or ethanol).

[0088] One strategy for creating 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 creating access is to deploy self-assembling magnets via an endoscopic needle 600, such as Fig.9A and Fig. 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 will be deployed into the gallbladder, and the mating device will be deployed into the stomach or duodenum. In the same manner as discussed above with respect to gastrointestinal deployment, the tissue surrounded 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 left to necrotize and form an anastomosis.

[0089] However, the device need not be limited to forming holes. Other structures can be coupled to one or more cooperating magnetic devices to create additional functionality. For example, a stent can be deployed between tissues, such as between a gallbladder and a stomach, such as Fig.10 Alternatively, the gallbladder magnet can be coupled to a balloon-based device filled with air, fluid, magnetic flakes, or magnetic particles. When inflated, the balloon will act as an anchor in the bile duct after deployment. The balloon can also have a circular configuration to allow for immediate access after coupling with a second magnet. See, e.g. Fig.11 However, regardless of the implementation, it is critical that the original entry path is contained within the confines of the coupling magnet, i.e., leaving no path for bile to escape. Otherwise, the opening will allow bile to leak, which may lead to peritonitis.

[0090] Another medical application of self-assembled magnets is direct bile duct access. At present, in order to achieve decompression of malignant bile duct strictures, endoscopic retrograde cholangiopancreatography (ERCP) is performed. The bile duct is entered endoscopically through the papilla in a retrograde manner, and a stent is deployed across the stricture on a guidewire. These stents often require subsequent procedures for exchanging, removing or setting additional overlapping stents. When using ERCP surgery, it is necessary to replace and clean to offset the high infection rate (i.e., cholangitis) of the biliary system. Due to the high morbidity, ERCP is usually limited to patients who have no other options to solve pancreatic diseases.

[0091] However, using the device of the present invention, an anastomosis (common bile duct-gastric anastomosis and common bile duct-duodenal anastomosis, respectively) can be easily formed between the bile duct (preferably the main bile duct) and the duodenum or stomach. 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 means of a detachable wire or suture to enable mechanical retraction until optimal positioning is confirmed.

[0092] In one embodiment, the magnetic device can be delivered endoscopically through the duodenal wall to the bile duct, e.g. Fig.12 In another embodiment, the biliary magnet can be delivered into the bile duct via the ampulla in a conventional retrograde manner, such as Fig.13 One benefit of retrograde delivery is that it avoids Fig.12 However, regardless of the method used to deliver the bile magnet, a second magnetic device is required in the gastric cavity A or the duodenal cavity B, such as Fig.14 as shown. Typically, this decision depends on the patient's anatomy (e.g., size of the duodenal lumen) and the location of the initial biliary magnet. In an endoscopic ultrasound needle delivery-based scenario, 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 connection after the biliary magnet is deployed. The latter process may be more applicable to forward-looking ultrasound endoscopes, but can be used with endoscopes in general.

[0093] In another embodiment, the biliary magnet is a balloon based device that is filled with air, fluid, magnetic members or magnetic particles, similar to what was previously described for gallbladder surgery. When inflated, the balloon will serve as an anchor in the bile duct after deployment. In one embodiment, the balloon can have a circular configuration to allow for immediate entry after coupling with a second magnet. Additionally, as with the gallbladder surgery described above, the biliary magnetic device can be used with a stent form factor. In one embodiment, a stent has an internal bile magnet and an attached external magnet. The stent can be inserted into the bile duct through the ampulla in a retrograde manner. The attached external magnet can then swing around the internal bile duct magnet and couple with the internal bile duct magnet to form a fistula between the bile duct and the duodenum, as described above. Fig.15 shown.

[0094] 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 sliced ​​along the axis of the pancreatic 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 the stomach or duodenum, such as Fig.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 straw. The pancreatic duct can be accessed using conventional ERCP methods (retrograde cannulation through the ampulla) or by direct needle entry using endoscopic ultrasound (EUS). The magnetic pancreatic catheter can be delivered into the pancreatic duct and connected to a second magnetic device in the stomach or duodenum. As in the biliary case described above, the magnetic pancreatic catheter can be linked to a second magnetic device.

[0095] Self-assembled magnetic devices can also be used to access and drain fluid collections located near the gastrointestinal tract, such as Fig.17 For example, following pancreatitis, a pancreatic effusion may develop that requires drainage. While drainage can be accomplished using surgery or a percutaneous catheter, endoscopic drainage has been found to be more clinically cost-effective, but may be complicated by bleeding, perforation, and / or inadequate drainage. As an alternative to surgical drainage, the magnetic device of the present invention may be delivered to the collection through a needle or sharp catheter under endoscopic ultrasound (EUS) guidance, such as Fig.17 As shown. After assembly, the first magnetic device is coupled to a second magnetic device that has been placed in the gastrointestinal cavity (e.g., the stomach). To accelerate removal after expulsion, the first magnet can be tethered by a connecting wire as previously described. As previously described, electrocautery or dilation can be used, followed by needle and wire access to cut the intervening tissue. Additional devices, such as magnetic coupling clips, can be used to control blood flow, thereby achieving "bloodless" endoscopic access to the accumulation area.

[0096] Self-assembled magnets can also be used in urological applications, such as forming bypasses to treat obstructed urogenital tracts, e.g. Fig.18 As shown. For example, a magnetic anastomosis can be created between a renal calyx and a bowel A, between a ureter and a bowel B, or between a bladder and a bowel C. As described above, the self-assembling magnetic device of the present invention can be delivered into the urinary tract using an endoscope, a laparoscope, or a needle. As previously described, the reciprocating magnetic device can be delivered into the gastrointestinal tract using an endoscope, a laparoscope, or a needle. In other embodiments, the device can be used in reproductive surgery, such as bypassing a portion of a blocked fallopian tube or bypassing a vasectomy.

[0097] In yet another application, self-assembled magnetic devices can be used to create vascular anastomoses or treat heart disease. Fig.19 As shown, a magnetic anastomosis connection can be formed between adjacent blood vessels with a magnetic device. In one embodiment, the self-assembled device can be delivered with a vascular delivery device (e.g., a catheter). In addition, as described above for gallbladder and pancreatic applications, a shunt can be installed to bypass a portion of a weak or blocked vasculature.

[0098] Self-assembled magnets can also be used for pulmonary applications, such as creating bypasses in airways to treat chronic obstructive pulmonary disease (COPD). For example, magnetic anastomosis can be created by deploying self-assembled magnetic devices into adjacent bronchioles, such as Fig. 20 The creation of a lung "bypass" can reduce the airway resistance that characterizes respiratory diseases such as COPD.

[0099] The self-assembling magnetic device can also be used to create a surgical stoma for diverting stool flow into, for example, a colostomy bag. For example, a magnetic anastomosis can be created by deploying the self-assembling magnets into the gastrointestinal tract (e.g., the large intestine), such as Fig.21 As shown, the internal magnet is then coupled to an external magnet that is worn and fixed at skin level. The external magnetic device can be coupled to yet a third magnetic device, which is coupled to the collection device. Such a system allows the collection device to be easily removed for cleaning, etc.

[0100] Although various inventive embodiments have been described and illustrated herein, it will be readily apparent to those of ordinary skill in the art that various other devices and / or structures for performing functions and / or obtaining results and / or one or more advantages described herein will be contemplated, and each of these changes and / or modifications is considered to be within the scope of the inventive embodiments described herein. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications using the teachings of the present invention. Those skilled in the art will recognize or be able to determine many equivalents of the specific inventive embodiments described herein using no more than routine experiments. Therefore, it should be understood that the foregoing embodiments are presented only as examples, and within the scope of the appended claims and their equivalents, inventive embodiments may be implemented in a manner different from that specifically described and claimed. Inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, if such features, systems, articles, materials, kits, and / or methods are not mutually contradictory, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention disclosed herein.

[0101] Various inventive concepts may be embodied as one or more methods, examples of which have been provided. The actions performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in an order different from that shown, which may include performing some actions simultaneously, even though shown as sequential actions in illustrative embodiments.

[0102] All terms defined and used herein should be understood to control over dictionary definitions, definitions in reference documents, and / or ordinary meanings of the defined terms.

[0103] As used herein in the specification and claims, the indefinite articles "a" and "an" should be understood to mean "at least one" unless explicitly indicated to the contrary.

[0104] The phrase "and / or" as used herein in the specification and claims should be understood to mean "either or both" of the elements so combined, i.e., elements that are present in combination in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified. Thus, as a non-limiting example, when used in conjunction with open language such as "comprising", a reference to "A and / or B" may refer to only A (optionally including elements other than B) in one embodiment; to only B (optionally including elements other than A) in another embodiment; to both A and B (optionally including other elements) in yet another embodiment; and so on.

[0105] As used herein in the specification and 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, that is, including at least one of a plurality of elements or a list of elements, but also including more than one, and optionally, additional unlisted items. Only when the opposite terms are clearly indicated, such as "only one" or "just one", or when used in the claims, "consisting of..." will refer to including exactly one element in a plurality of elements or a list of elements. Usually, when there is an exclusive term (such as "any", "one of them", "only one of them" or "just one of them") in front, the term "or" used herein should only be interpreted as indicating an exclusive alternative (that is, "one or the other but not both"). When used in the claims, "consisting essentially of..." should have its ordinary meaning used in the field of patent law.

[0106] As used herein in the specification and claims, the phrase "at least one" with respect to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the list of elements, but does not necessarily include at least one of each element specifically listed in the list of elements, and does not exclude any combination of elements in the list of elements. This definition also allows that elements other than the elements specifically identified in the list of elements referred to by the phrase "at least one" may optionally be present, whether related or unrelated to those elements specifically identified. 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") may refer to at least one (optionally including more than one) A, without B (and optionally including elements other than B) in one embodiment; in another embodiment, to at least one B, optionally including more than one B, without A (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 on.

[0107] As used herein in the specification and claims, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "having," "consisting of," and the like shall be construed as open ended, i.e., meaning including, but not limited to, "consisting of." Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in Section 2111.03 of the U.S. Patent Office Manual of Patent Examining Procedures.

[0108] The various embodiments of the present invention may 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 written description of this application. Therefore, the subject matter of the following potential claims may be presented as actual claims in subsequent proceedings involving this application or any application claiming priority based on this application. The inclusion of such potential claims should not be interpreted as meaning that the actual claims do not cover the subject matter of the potential claims. Therefore, the decision not to present these potential claims in subsequent proceedings should not be interpreted as donating the subject matter to the public. These potential claims are also not intended to limit the various pursued claims.

[0109] Without limitation, potential subject matter that may be claimed (prefixed with the letter "P" to avoid confusion with the actual claims set forth below) includes:

[0110] P1. A separate magnetic vertebral segment for a magnetic compression anastomosis device, comprising: a vertebral skin comprising a metal alloy, a polymer and / or a composite material; a flexible segment constructed as a tensile member; a spring-flexible member constructed to assist in forming an array; and a roller constructed to provide radial constraints and limit degrees of freedom to strengthen the array from a torsional perspective.

[0111] P2. The vertebrae of claim PI, further comprising: rollers or nodes configured to produce rotation in one plane while limiting opposite 90 degrees of torsional freedom; and stops configured to limit one or more degrees of freedom.

[0112] P3. The vertebrae of claim PI further comprising: a male node of a first vertebra configured to interlock with a female node of a second vertebra, wherein the vertebrae are shaped to provide interference to allow a specified amount of rotation about the axis of the male node and the female node.

[0113] Although the above discussion discloses various exemplary embodiments of the present invention, it should be apparent that those skilled in the art may make various modifications that will achieve some of the advantages of the present invention without departing from the true scope of the present invention. Any reference to the "invention" is intended to refer to 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 should be considered in all respects to be illustrative only and not restrictive.

Claims

1. A magnetic compression anastomosis device, comprising: A plurality of connected vertebrae, the plurality of connected vertebrae comprising a first vertebra and a second vertebra, wherein each of the first vertebra and the second vertebra is a multi-piece vertebra, the multi-piece vertebra comprising a magnet at least partially encapsulated by vertebral skin, and wherein the first vertebra and the second vertebra are interconnected by cylindrical rollers and at least one flexible element, the rollers and the at least one flexible element being at least partially encapsulated by the first vertebra skin and the second vertebra skin, the rollers being configured to allow the first vertebra and the second vertebra to pivot through a predetermined rotational range in a plane of the device between at least a delivery configuration and an assembly configuration while constraining movement in other degrees of freedom, the at least one flexible element biasing the first vertebra and the second vertebra toward the assembly configuration.

2. The device according to claim 1, wherein: The vertebral skin includes at least one of a metal alloy, a polymer, or a composite material.

3. The device according to claim 1, wherein: The vertebral skin includes a shape memory material.

4. The device according to claim 1, wherein: The vertebral skin is configured with at least one tissue cutting element.

5. The device according to claim 1, wherein: The vertebral skin is configured with at least one tissue compression element.

6. The device according to claim 1, wherein: The vertebral skin is configured with at least one tissue fixation element.

7. The device according to claim 1, wherein: Each vertebral skin includes a male node and a female node located at opposite ends of the vertebral skin.

8. The device according to claim 7, wherein: The male node is configured to secure the roller in place.

9. The device according to claim 1, wherein: The roller is a hollow cylinder.

10. The device according to claim 1, wherein: The roller is a solid cylinder.

11. The device according to claim 1, wherein: The flexible element includes a flexible rod.

12. The device according to claim 11, wherein The flexible rod includes a spring mechanism.

13. The device according to claim 12, wherein: The spring mechanism includes a shape memory material.

14. The device according to claim 1, wherein: The flexible element includes a pair of U-shaped frames operatively coupled to the rollers.

15. The device according to claim 1, wherein: The roller and the flexible element are implemented using a helical spring or a torsion spring.

16. The device according to claim 1, wherein The vertebrae are aligned in a substantially straight configuration in the delivery configuration.

17. The device according to claim 1, wherein: The vertebrae are arranged in a circular configuration in the assembled configuration.

18. The device according to claim 1, wherein: The vertebrae are arranged in a polygonal structure in the assembled configuration.

19. The device according to claim 1, wherein: The vertebrae include a proximal vertebra and a distal vertebra that are magnetically coupled to one another in the assembled configuration.

20. A magnetic compression anastomosis system, comprising: a delivery device comprising a lumen; and At least one magnetic compression anastomotic device according to claim 1, which is pre-positioned within the lumen of the delivery device in the delivery configuration.

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