Pressure Profile Magnetic Compression Anastomosis Device

Abstract

A compression anastomosis device having multiple distinct pressure profile zones on the surface of the device. The anastomosis device may be composed of multiple magnetic connecting members arranged in an annular geometric shape, such as a polygon or circle. The anastomosis device may also be a continuous, non-segmented magnet or other compression anastomosis device. The compression anastomosis device is deployed within a body lumen at a target site, for example, endoscopically and / or laparoscopically. A second compression anastomosis device is placed at an adjacent target site in an adjacent lumen. The compression anastomosis devices join, for example, magnetically mate, to create an anastomosis.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 403,181, entitled "MAGNETIC ANASTOMOSIS DEVICES WITH VARYING MAGNETIC FORCE AT A DISTANCE," filed September 1, 2022, which is incorporated 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. [Background technology]

[0003] 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 result in 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 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, the magnets or couplings must be delivered as two separate assemblies, requiring either an open surgical field or a bulky delivery device. 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, placement of the magnet or coupling can be imprecise, potentially resulting in anastomosis formation in an undesirable or inaccurate location.

[0006] Tissues of different thicknesses require different pressures to puncture the tissue and / or to bring it close enough to engage the magnetic anastomosis device. Sharp pressure profiles can cause abrupt transitions between healthy and necrotic tissue, potentially resulting in poor sealing of the anastomosis.

[0007] Therefore, a clinical need remains for reliable devices and minimally invasive procedures that facilitate the formation of compression anastomoses between tissues of the human body in as few steps as possible. Summary of the Invention [Means for solving the problem]

[0008] According to one embodiment, a magnetic compression anastomosis device comprises at least one magnetic member forming an annular shape including a tissue engaging surface comprising a plurality of distinct pressure profile zones selected from the group consisting of a cutting zone, a rapid release zone, a tissue fusion zone, a relief zone, and a fixation zone.

[0009] In various alternative embodiments, the relief zone can generate a pressure of about 0 psi to about 25 psi on the body tissue, the tissue fusion zone can generate a pressure of about 25 psi to about 250 psi on the body tissue, the fast release zone can generate a pressure of about 250 psi to about 40,000 psi on the body tissue, and the cutting zone can generate a pressure of about 40,000 psi to about 75,000 psi on the body tissue. The multiple distinct pressure profile zones can include an inner cutting zone, a fast response zone adjacent to the inner cutting zone, a tissue fusion zone adjacent to the fast response zone, and a relief zone adjacent to the tissue fusion zone. The anchoring zone can include a knurled or cross-hatched geometric profile. The geometric profile of at least one of the distinct pressure profile zones can be non-uniform and non-linear. The cutting zone can include an angled cutting pressure profile. The annular shape can be polygonal or circular. The at least one magnetic member can include multiple magnetic members assembled into an annular shape or a single magnetic member forming an annular shape.

[0010] In additional embodiments, the system can include first and second magnetic compression anastomosis devices of the type described above, with the second magnetic compression anastomosis device configured to engage the first magnetic compression anastomosis device. The first and second devices can have the same pressure profile configuration or different but complementary pressure profile configurations.

[0011] Additional embodiments may be disclosed and claimed.

[0012] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

[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] A magnet assembly is shown being delivered through an endoscopic instrument channel so that the individual magnets self-assemble into a larger magnetic structure, in this particular case an octagon. [Figure 2A] 1 shows the magnet assembly delivered and deployed into adjacent tissue. [Figure 2B] Shown are two magnet assemblies coupled together by magnetic attraction to capture intervening tissue. In some cases, an endoscope can be used to cut the circumscribed tissue. [Figure 3] Several potential anatomical targets for anastomosis creation are shown: Arrow A is from the stomach to the small intestine, arrow B is from the small intestine to the large intestine, arrow C is from the small intestine to the small intestine, arrow D is from the large intestine to the large intestine, and arrow E is from the stomach to the large intestine. [Figure 4A] 1 shows one embodiment of delivery using two endoscopes (a colonoscope and an enteroscope or gastroscope) to deliver the magnet assembly. [Figure 4B] 13 shows another embodiment of delivery using two upper endoscopes sharing a transoral portal for delivering the magnet assembly. [Figure 5] 13 illustrates another embodiment of delivery using a single endoscope to sequentially deliver the magnet assemblies. [Figure 6] 10 shows another embodiment of delivery of one magnet assembly into lumen #1 using endoscopic ultrasound guide needle delivery, followed by delivery of a second magnet assembly into lumen #2 from deployment. [Figure 7]Illustrated is the creation of a preliminary anastomosis that serves as a conduit for deeper endoscopic delivery for the creation of subsequent multiple anastomoses. [Figure 8] 1 shows laparoscopic magnetic device delivery into a lumen (in this example, the stomach). [Figure 9] FIG. 9A shows 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] 1 shows stent deployment between the gallbladder and either the stomach or duodenum. [Figure 11] 10 shows another embodiment of an intragallbladder magnet assembly that is a balloon filled with fluid, gas, or magnetic material, tethered to an endoscope and initially delivered through an ultrasound endoscopic guide needle. [Figure 12] 10 shows endoscopic ultrasound-guided needle delivery of a magnet assembly into a bile duct. [Figure 13] 1 shows magnet assembly delivery into the bile duct via an endoscopic retrograde cholangiopancreatography technique. [Figure 14] Shown is the coupling of an intrabiliary magnet assembly with a second magnet assembly deployed in either the stomach (A) or duodenum (B). [Figure 15] 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] 1 shows 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 create a draining anastomosis for the pancreatic duct. [Figure 17] Shown is a magnetic assembly delivered to the peripancreatic reservoir (dotted structure) using ultrasound endoscopic guided needle / catheter delivery coupled with a second magnetic assembly deployed within the stomach. [Figure 18] Different targets for anastomosis between the urinary and gastrointestinal systems are shown, such as the renal calyx (A), ureter (B) and bladder (C). [Figure 19] 1 shows a magnet assembly within adjacent blood vessels for joining and forming a vascular anastomosis. [Figure 20] 1 shows the magnet assembly in different parts of the respiratory system for creating anastomoses between adjacent bronchioles. [Figure 21] 1 shows an external and internal magnet assembly within the digestive tract used to create an artificial stoma for fecal evacuation. [Figure 22] 10A-10C illustrate schematic diagrams of a compression anastomosis device with various pressure profiles. [Figure 23] 1A-1D illustrate schematic cross-sections of compression anastomosis devices with various geometric profiles. [Figure 24] 10A-10C show schematic cross-sections of various geometric pressure profiles; [Figure 25] 10A-B illustrate schematic diagrams of various reciprocating pressure profiles for two compression anastomosis devices. [Figure 26] 10A-B show schematic diagrams of reciprocating pressure profiles for two compression anastomosis devices. [Figure 27] 10A-B schematically illustrate the overlapping geometry of two compression anastomosis devices across a tissue segment. [Figure 28] 1 illustrates schematically a compression anastomosis device with non-uniform / non-linear geometry. [Figure 29] 10A-10C schematically illustrate a compression anastomosis device having a knurled and cross-hatched pattern. [Figure 30] 10A-10C illustrate schematic diagrams of a compression anastomosis device with a cutting pressure profile. [Figure 31] 10A-10C show schematic views of a close-up of a mating compression anastomosis device. [Figure 32] 1A and 1B illustrate schematically a compression anastomosis device having one or more alternating pressure profile zones. [Figure 33] 1A and 1B illustrate schematically a compression anastomosis device having two or more alternating pressure profile zones. [Figure 34] 1A-1D illustrate schematic cross-sections of compression anastomosis devices with various geometric profiles. [Figure 35] 1 illustrates a schematic representation of a compression anastomosis system having an insulating jacket. DETAILED DESCRIPTION OF THE INVENTION

[0015] It should be noted that the foregoing figures and the elements depicted therein are not necessarily drawn to consistent or any scale. Similar elements are designated with similar reference 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] Various embodiments of the present invention include compression anastomosis devices with various geometric profiles across the surface of the device. The anastomosis device may be comprised of multiple magnetic connecting members arranged in an annular geometric shape, such as a polygon or circle. The anastomosis device may also be a continuous, non-segmented magnet or other compression anastomosis device. The compression anastomosis device is deployed within a body lumen at a target site, e.g., endoscopically and / or laparoscopically. A second compression anastomosis device is placed at an adjacent target site in an adjacent lumen. The compression anastomosis devices join, e.g., magnetically mate, to create the anastomosis.

[0017] The tissue-engaging surface of the compression anastomosis device has a varying geometric profile across the surface of the device to allow for varying pressure on the tissue of the anastomosis. For example, the outer diameter of the device can have a lower pressure profile to allow for a smooth transition between healthy and necrotic tissue, while the inner diameter has a higher pressure profile to perforate the tissue. This allows for the creation of a stronger anastomosis and greater patient success.

[0018] 22 illustrates one embodiment of a variable pressure profile compression anastomosis device 100. One or more faces of the compression anastomosis device have geometric profiles that vary across the surface of the device, with each profile capable of applying a different pressure to a tissue site.

[0019] As shown in Figure 23, each compression anastomosis device can have a varying geometric profile across the surface of the device including one or more profile zones. The profile zones can include, but are not limited to: A relief profile that allows for 0-25 psi to be applied to the tissue site. This profile gradually increases pressure along the profile, allowing for a smooth transition between healthy and necrotic tissue. A tissue fusion profile that applies 25-250 psi to the tissue site. This profile applies the necessary pressure to prevent interstitial fluid exchange across the compression anastomosis device, causing tissue necrosis and forming a collagenous seal. A fast-release profile capable of applying 250 to 40,000 psi to the tissue site. This profile applies the pressure necessary to release the anastomotic device at the boundary where the pressure is at its peak. A cutting profile capable of applying 40,000 to 75,000 psi to a tissue site. This profile applies the pressure necessary to perforate one or more tissue segments.

[0020] FIG. 24 schematically illustrates cross sections of various geometric profiles on a compression anastomosis device. Geometric profiles can include, but are not limited to, those shown in FIG. 24. The force and area of ​​the pressure profile zone determine which of four zones the geometric profile falls into. Geometric profile zones can include, but are not limited to, a relief zone (0-25 psi), a tissue fusion zone (25-250 psi), a fast release zone (250-40,000 psi), and / or a cutting zone (40,000-75,000 psi). For compression anastomosis devices, the geometric profile, along with the maximum force available within the system, determines the pressure.

[0021] Figures 25(A)-25(C) schematically illustrate various reciprocating pressure profiles for two compression anastomosis devices. As shown in Figure 25(A), one compression anastomosis device includes a geometric pressure profile that varies across the surface of the device, while the second compression anastomosis device has a reciprocating geometric profile. This allows the two anastomosis devices to mate with each other and create a compression anastomosis. The gap between the mating profiles can vary based on the geometry or mating agreement. The assembly of two mating compression anastomosis devices helps to trap tissue between their features to reduce tissue slippage. When mating two reciprocating compression anastomosis devices, the varying geometric profile across the surface of the device allows the two devices to self-position and mate, creating the anastomosis.

[0022] Figure 26 schematically illustrates the reciprocating geometric profile between two compression anastomosis devices. The two reciprocating devices mate across tissue within adjacent body lumens, overlapping their geometries to facilitate incision creation. As shown in Figure 26, the cutting profile of the left anastomosis device overlaps with the inner diameter of the right magnet, allowing an incision to be created once a specific compression distance is achieved.

[0023] Figures 27(A)-27(B) show schematic diagrams of two mating compression anastomosis devices with tissue between them. The overlapping geometry of the compression anastomosis devices causes immediate release of tissue within the inner diameter of the device, allowing immediate nutrient and fluid passage. This occurs in conjunction with the formation of a sealed anastomosis.

[0024] 28 schematically illustrates a non-limiting example of a compression anastomosis device that includes a non-uniform / non-linear pattern along the surface of the device. The non-uniform pattern can include one or more of the pressure profile zones described above. The shape and size of the non-uniform / non-linear pattern are limited by the pressure profile zones.

[0025] 29(A)-29(B) schematically illustrate non-limiting examples of compression anastomosis devices that include a knurled pattern (FIG. 29(A)) and a cross-hatched pattern (FIG. 29(B)). These patterns, and others not shown, help secure tissue and prevent slippage when the compression anastomosis device is secured at the anastomosis site.

[0026] Figures 30(A)-30(B) show schematic diagrams of a compression anastomosis device with angled cutting pressure profiles on the face of the device. When two compression anastomosis devices are mated (Figure 30(A)), the cutting profiles overlap (Figure 30(B)), shearing the tissue apart and allowing immediate passage of nutrients and fluids through the anastomosis.

[0027] Figure 31 shows a schematic of a close-up view of a mating compression anastomosis device. The device has a reciprocating geometry, allowing for an angled cutting pressure profile to interlock. Design features include, but are not limited to, a tapered cutting profile that allows for overlapping of the device. The overlapping geometry of the compression anastomosis device allows for shearing of tissue and immediate passage of nutrients and fluids through the created anastomosis.

[0028] Figure 32 schematically illustrates a compression anastomosis device with one or more alternating pressure profile zones. Figure 33 illustrates a compression anastomosis device with two or more pressure profile zones with a single geometric shape. These configurations allow the compression anastomosis device to provide one or more functions, such as, but not limited to, relief, tissue fusion, fast release, and / or cutting. This can include, but is not limited to, the profile zones shown.

[0029] 34 schematically illustrates a cross section of a compression anastomosis device including a cutting profile, tissue fusion, and fast release profile. The cutting pressure profile gradually smooths into the tissue fusion and / or fast release profile, allowing the compression anastomosis device to puncture tissue segments and bring them closer together to form an anastomosis.

[0030] Figures 35(A)-35(C) schematically illustrate a compression anastomosis device with an insulating jacket that allows energy to be applied to the device. The insulating jacket is placed inside the compression anastomosis device. After the device is engaged across the tissue (Figure 35(A)), an energy applicator can be used to create a central incision (Figures 35(B) and 35(C)). The compression anastomosis device holds the tissue in place to prevent movement of the device when cauterization is applied. Utilizing an energy applicator to create the central incision allows for the immediate passage of nutrients and fluids through the anastomosis.

[0031] 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 device 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.

[0032] Thus, as described herein, embodiments include flexible linear magnetic devices comprising linked magnetic multipole segments that self-assemble to form a rigid multipole polygonal ring magnet (PRM, generally referred to as a "magnetic device") when extruded from the end of a deployment channel or lumen. Self-assembly is guided by a configuration of magnets, rollers, flex elements, and vertebral skin 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 coupling between the magnetic devices. In some instances, complementary devices must be pre-aligned, while in other instances, as discussed in detail below, the devices self-align by undergoing rapid in-plane rotation relative to each other. As discussed in detail below, systems including magnetic devices can include endoscopes with sensors that enable the endoscope to sense the position of a mating magnetic device or another endoscope deploying a mating device.

[0033] When deployed in adjacent tissues, such as adjacent organs or different regions of the same organ, the coupled magnetic devices create a compression ring that can be surgically opened or an anastomosis can be formed without further intervention. If the pair of devices is 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 fuse 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.

[0034] 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.

[0035] The deployment of device 100 is shown schematically in Figure 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 within a standard endoscope, when 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 devices 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.

[0036] As shown in FIG. 2A, a magnetic anastomosis procedure generally involves placing first and second magnetic structures adjacent to target tissues, thus bringing the tissues together. The magnetic devices are typically deployed so that opposing poles of the magnets attract and join the tissues. Both devices may be deployed within the body, or one may be deployed within 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 device necroses and decomposes, providing an opening between the tissues. While the illustrations 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 make delivery (and removal) easier.

[0037] As described with respect to the figures, the self-assembling magnetic anastomosis device can be deployed using several techniques, such as endoscopy, laparoscopy, or catheterization (e.g., rather than direct visualization, fluoroscopy, etc.). 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.

[0038] In some embodiments, self-assembling magnetic devices are used to create a bypass in the digestive tract. Such bypasses can be used for cancerous blockages, weight loss or obesity treatment, or even diabetes and metabolic disease treatment (i.e., metabolically improving 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, 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, devices can be deployed using two simultaneous upper endoscopes (e.g., one present in the stomach and the second present in the small intestine). In other embodiments, 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.

[0039] 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 and provide the necessary compressive force to facilitate the formation of the anastomosis. Ideally, the devices can be positioned (e.g., using ultrasound) approximately within a few centimeters of each other, 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 anastomosis positioning. For example, a magnetic deployment tool (described below) is deflected by the presence of a device deployed on the opposite side of the tissue wall.

[0040] A second positioning technique involves transillumination, whereby high-intensity light from one endoscope is directed at 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 align the endoscope tip. In some embodiments, the system includes an endoscope with a sensor and a magnetic anastomosis device for deployment using the endoscope.

[0041] 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.

[0042] With transillumination and magnetic sensing, 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 seated onto the outer diameter of the scope. The outer diameter of this expander element is sized to allow the deployed device to seat onto the expander element (again, likely a press fit). With this expander element and magnetic device radially seated around the endoscope shaft, the endoscope can be directed to the ideal anastomosis location by direct contact, transillumination, or magnetic sensing, and then the mating magnetic device is released when the anastomosis site is identified.

[0043] In other embodiments, the self-assembling magnet device can be delivered using ultrasound guidance, such as endoscopic ultrasound. For example, an intragastric echo endoscope 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 magnet into the small intestinal lumen. Note that delivery can be guided by fluoroscopy or endoscopic ultrasound. Following self-assembly, these small intestinal magnets combine with 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 with an endoscope and the second device with a needle, or vice versa.

[0044] In another embodiment, shown in FIG. 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 to "titrate" for specific clinical effects (e.g., hypoglycosylated hemoglobin in type 2 diabetes). In alternative embodiments, anastomoses may be placed to provide access for different types of surgery, such as tumor removal.

[0045] In another embodiment of delivery, self-assembling magnets may be delivered laparoscopically through a surgical incision to a target organ (e.g., the stomach and small intestine) and coupled to create an anastomosis, as shown in Figure 8. Again, this procedure can be fluoroscopically or ultrasound guided, and the procedure can be purely laparoscopic, or a combination of endoscopic and / or laparoscopic and / or needle procedures.

[0046] 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 obesity and metabolic conditions such as type 2 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.

[0047] Using the self-assembling magnetic device 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 device 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 "corrected" digestion to be adjusted based on the goals of the treatment. In other words, using the described treatment, the physician can select the ratio of food / fluid flowing through the new (partial) bypass to the old pathway. In most cases, the fraction flowing through the bypass limb will direct the patient toward the desired clinical endpoint (e.g., weight loss, improved glycosylated hemoglobin, improved lipid profile, etc.). The mechanism by which the 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 fragments flowing through the old pathway protect against known metabolic complications that can be associated with bariatric surgery, such as excessive weight loss, malabsorptive diarrhea, electrolyte disturbances, and malnutrition.

[0048] The size, location, and possibly number of anastomoses are important to achieve the desired bypass ratio (e.g., rerouting food and secretions to a new pathway, 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 specific clinical endpoints (e.g., glycosylated hemoglobin in type 2 diabetes). Most of the procedures described herein can be used to place one or more anastomoses as needed to achieve the desired clinical endpoint. For example, 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 greater than 1 cm, or several smaller anastomoses may be placed to achieve the desired ratio.

[0049] Treatments can also be adjusted. For example, a first anastomosis can be created, and then, based on post-procedure clinical trials, one or more anastomoses can be added to improve clinical trial results. Based on subsequent clinical results, additional anastomoses may be required. 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 of nutrients crossing 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 globally and adjustably create a partial bypass or a series of partial bypasses between segments of the intestine to achieve a clinical endpoint.

[0050] The described procedures can also be used in conjunction with procedures to remove or block bypassed tissue, as is common in the treatment of obesity. For example, a gastrojejunostomy can be combined with a pyloric plug (gastric obstruction) or another closure of the pylorus (e.g., suture closure) to allow food to flow completely through the new bypass. Such procedures can be used, for example, to bypass tissue affected by cancer.

[0051] 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 retrieved and fluids drained endoscopically. 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 ablated using any number of therapies, including, but not limited to, argon plasma coagulation (APC), photodynamic therapy (PDT), and sclerosing agents (e.g., ethanolamine or ethanol).

[0052] 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 vein 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, non-angular, 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 cautery, a microscalpel, a needle knife, or other deployable cutting mechanism. In another embodiment, the combined tissue can be necrosed, forming an anastomosis.

[0053] 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 deployment. The balloon can also have an annular configuration for ready 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.

[0054] 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.

[0055] 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.

[0056] As shown in Figure 12, in one embodiment, the magnetic device can be delivered endoscopically to the bile duct through the duodenal wall. In another embodiment, as shown in Figure 13, the bile duct magnet can be delivered traditionally retrogradely through the ampulla into the bile duct. One advantage of retrograde delivery is that it avoids needle puncture across tissue planes, as is the case with the deployment method shown in Figure 12. However, regardless of the method of bile duct magnet delivery, a second magnetic device is required in either the gastric (A) or duodenal (B) lumen, as shown in Figure 14. This decision typically depends on the patient's anatomy (e.g., the size of the duodenal lumen) and the initial bile duct magnet location. 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 a forward-looking echoendoscope, it can generally be used with an endoscope.

[0057] In another embodiment, the bile duct magnet is a balloon-based device filled with air, fluid, magnetic particles, or magnetic particles, similar to those described above for the gallbladder procedure. When inflated, the balloon acts as an anchor within the bile duct after deployment. 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 with the internal bile duct magnet to form a fistula between the bile duct and the duodenum, as shown in Figure 15.

[0058] 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 cut 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 bile duct scenario described above, the magnetic pancreatic catheter can be hinged to the second magnetic device.

[0059] 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. While drainage can be achieved using surgery or a percutaneous catheter, 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 device of the present invention can be delivered to the collection through a needle or sharp catheter under endoscopic ultrasound (EUS) guidance, as shown in Figure 17. After assembly, the first magnetic device is coupled to a second magnetic device placed within 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.

[0060] As shown in FIG. 18, self-assembling magnets can also be used in urological applications, such as forming a bypass to treat a blocked urogenital tract. 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, mutual magnetic devices 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 a blocked fallopian tube or bypassing a vasectomy.

[0061] 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 coupling 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.

[0062] Self-assembling magnets can also be used in pulmonary applications, such as creating a bypass in the airway to treat chronic obstructive pulmonary disease (COPD). For example, a magnetic anastomosis can be created by deploying a self-assembling magnetic device to adjacent bronchioles, as shown in Figure 20. Creating a pulmonary "bypass" could reduce the airway resistance that characterizes respiratory diseases such as COPD.

[0063] Self-assembling magnetic devices can also be used to create surgical stomas, for example, for diversion of 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.

[0064] 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 present disclosure are directed 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 within the inventive scope of the present disclosure, if such features, systems, articles, materials, kits and / or methods are not mutually inconsistent.

[0065] 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.

[0066] 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.

[0067] The indefinite articles "a" and "an," as used in this specification and claims, unless expressly indicated otherwise, should be understood to mean "at least one."

[0068] 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, refer to B only (optionally including elements other than A); in yet another embodiment, refer to both A and B (optionally including other elements); and so on.

[0069] 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 indicated to 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 of," "only one of," "exactly one of," or "consisting essentially of," 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.

[0070] 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.

[0071] As used in this 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.

[0072] Without limitation, potentially claimed subject matter (prefaced with the letter "P" to avoid confusion with the actual claims presented below) includes:

[0073] P1. An apparatus for creating a compression anastomosis, the apparatus comprising: a compression anastomosis device having an annular shape; and an upper surface parallel to a diameter of the compression anastomosis device, the upper surface comprising one or more geometric profiles.

[0074] P2. The apparatus of any prior art innovation, further comprising: a second compression anastomosis device having an annular shape; and a second upper surface parallel to a diameter of the second compression anastomosis device, wherein the second upper surface comprises one or more geometric profiles, and wherein the one or more geometric profiles of the second upper surface complement the one or more geometric profiles of the first upper surface.

[0075] P3. The device of any prior art innovation, wherein the geometric profile is a relief profile capable of generating 0-25 psi on body tissue.

[0076] P4. The device of any prior art innovation, wherein the geometric profile is a tissue fusion profile capable of generating 25-250 psi on body tissue.

[0077] P5. The device of any prior art innovation, wherein the geometric profile is a fast release profile capable of generating 250 to 40,000 psi on body tissue.

[0078] P6. The apparatus of any prior art innovation, wherein the geometric profile is a cutting profile capable of generating 40,000 to 75,000 psi on body tissue.

[0079] P7. The apparatus of any prior art innovation, further comprising a plurality of connecting members arranged in an annular configuration, the plurality of connecting members comprising one or more geometric profiles.

[0080] P8. The apparatus of any prior art innovation, further comprising a second plurality of connecting members arranged in an annular configuration, the second plurality of connecting members comprising one or more geometric profiles, the one or more geometric profiles of the second plurality of connecting members complementing the one or more geometric profiles of the first plurality of connecting members.

[0081] P9. The apparatus of any prior art innovation, wherein the geometric profile is non-uniform and non-linear.

[0082] P10. The device according to any prior art innovation, wherein the geometric profile is knurled and / or cross-hatched.

[0083] P11. The apparatus of any prior invention, wherein the geometric profile is an angled cutting pressure profile.

[0084] P12. The apparatus of any prior art innovation, wherein the geometric profiles of the first plurality of connecting members and the second plurality of connecting members overlap.

[0085] P13. The apparatus of any prior art innovation, wherein the plurality of connecting members comprises one or more alternating profile zones.

[0086] P14. The apparatus of any prior art innovation, wherein the plurality of connecting members comprises two or more profile zones having one geometric shape.

[0087] P15. The device of any prior invention, further comprising an insulating jacket that can allow energy to be applied to the device.

[0088] 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: at least one magnetic member forming an annular shape including a tissue engaging surface with a plurality of distinct pressure profile zones selected from the group consisting of a cutting zone, a rapid release zone, a tissue fusion zone, a relief zone, and a fixation zone; Magnetic compression anastomosis device.

2. the relief zone is capable of generating a pressure on body tissue of from about 0 psi to about 25 psi; the tissue fusion zone is capable of generating about 25 psi to about 250 psi on the body tissue; the fast release zone is capable of generating from about 250 psi to about 40,000 psi on the body tissue; the cutting zone is capable of generating from about 40,000 psi to about 75,000 psi on body tissue; The device of claim 1 .

3. The plurality of distinct pressure profile zones include: an inner cutting zone; a fast response zone adjacent the inner cutting zone; a tissue fusion zone adjacent to the fast response zone; a relief zone adjacent to the tissue fusion zone; Equipped with The device of claim 1 .

4. the fixation zone has a knurled or cross-hatched geometric profile; The device of claim 1 .

5. the geometric profile of at least one of the distinct pressure profile zones is non-uniform and non-linear; The device of claim 1 .

6. the cutting zone comprises an angled cutting pressure profile; The device of claim 1 .

7. The annular shape is a polygon. The device of claim 1 .

8. The annular shape is circular. The device of claim 1 .

9. the at least one magnetic member comprises a plurality of magnetic members assembled into the annular shape; The device of claim 1 .

10. the at least one magnetic member is a single magnetic member forming the annular shape; The device of claim 1 .

11. A first magnetic compression anastomosis device according to claim 1; a second magnetic compression anastomosis device according to claim 1 configured to engage with the first magnetic compression anastomosis device; A system comprising:

12. the relief zone is capable of generating a pressure on body tissue of from about 0 psi to about 25 psi; the tissue fusion zone is capable of generating about 25 psi to about 250 psi on the body tissue; the fast release zone is capable of generating from about 250 psi to about 40,000 psi on the body tissue; the cutting zone is capable of generating from about 40,000 psi to about 75,000 psi on body tissue; The system of claim 11.

13. The plurality of distinct pressure profile zones of at least one of the first or second devices may comprise: an inner cutting zone; a fast response zone adjacent the inner cutting zone; a tissue fusion zone adjacent to the fast response zone; a relief zone adjacent to the tissue fusion zone; Equipped with The system of claim 11.

14. the fixation zone has a knurled or cross-hatched geometric profile; The system of claim 11.

15. the geometric profile of at least one of the distinct pressure profile zones is non-uniform and non-linear; The system of claim 11.

16. the cutting zone comprises an angled cutting pressure profile; The system of claim 11.

17. The annular shape is a polygon. The system of claim 11.

18. The annular shape is circular. The system of claim 11.

19. the at least one magnetic member comprises a plurality of magnetic members assembled into the annular shape; The system of claim 11.

20. the at least one magnetic member is a single magnetic member forming the annular shape; The system of claim 11.

21. the first and second devices have the same pressure profile configuration; The system of claim 11.

22. the first and second devices have different but complementary pressure profile configurations; The system of claim 11.

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