Pressure profile magnetic compression stapling device

Abstract

A compression stapling device has a plurality of different pressure profile regions on a surface of the device. The stapling device may include a plurality of magnetic connecting members arranged in an annular geometry (e.g., a polygon or a circle). The stapling device may also be a continuous, non-segmented magnet or other compression stapling device. The compression anastomosis device is deployed at a target site via, for example, an endoscope and / or laparoscope, into a human body lumen. A second compression stapling device is placed at an adjacent target site in an adjacent lumen. Compression stapling devices are joined together, and cooperate, for example magnetically, to form a stapling.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 403,181, filed on September 1, 2022, entitled “MAGNETIC ANASTOMOSIS DEVICESWITH VARYING MAGNETIC FORCE AT A DISTANCE,” 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 a desired site to improve the accuracy of anastomosis formation between tissues, organs and the like. Background Art

[0004] The bypass of gastroenterology (GI), cardiovascular or urology system is usually formed by cutting holes in the tissue at two positions and connecting the holes with sutures or nails. Usually the bypass is placed to guide liquid (e.g., blood, nutrients) between the healthier parts of the system while bypassing lesions or dysfunctional tissues. The process is usually invasive and subjects the patient to risks such as bleeding, infection, pain and adverse reactions to anesthesia. In addition, the bypass produced with sutures or nails can be complicated due to postoperative leakage and adhesion. Leakage can lead to infection or sepsis, and adhesion can lead to complications such as intestinal twisting and obstruction. Although traditional bypass surgery can be completed with endoscopes, laparoscopy or robots, it may be time-consuming to engage the holes cut into the tissue. In addition, such surgery requires specialized techniques and equipment that are unavailable at many surgical facilities.

[0005] 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 tissue to be joined. Due to the strong compression, the tissue captured between the coupling or magnets is cut off from its blood supply. Under these conditions, the tissue becomes necrotic and degenerates, while new tissue grows around the compression point, such as on the edges of the coupling. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0006] Nevertheless, the difficulty of placing magnets or couplings limits the locations where compression anastomosis can be used. In most cases, magnets or couplings must be delivered as two separate components, requiring 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 suffers from short-term patency. In addition, the placement of magnets or couplings may be imprecise, which may result in anastomosis formed in an undesirable or inaccurate location.

[0007] Tissues of varying thicknesses require varying pressures to pierce the tissue and / or bring the magnetic stapling devices close enough together to fit. Sharp pressure profiles may result in abrupt transitions between healthy tissue and necrotic tissue, which may result in a poor seal of the anastomosis.

[0008] Therefore, there remains a clinical need for reliable devices and minimally invasive procedures that facilitate the formation of compression anastomoses between human tissues with as few steps as possible. Summary of the invention

[0009] According to one embodiment, a magnetic compression anastomosis device includes at least one magnetic member, the at least one magnetic member forming an annular shape, the at least one magnetic member including a tissue engaging surface, the tissue engaging surface including a plurality of different pressure contour areas selected from the group consisting of: a cutting area, a quick release area, a tissue fusion area, a relief area, and a fixation area.

[0010] In various alternative embodiments, the relief zone is capable of generating a pressure between about 0 psi and about 25 psi on body tissue; the tissue fusion zone is capable of generating a pressure between about 25 psi and about 250 psi on body tissue; the rapid release zone is capable of generating a pressure between about 250 psi and about 40,000 psi on body tissue; and the cutting zone is capable of generating a pressure between about 40,000 psi and about 75,000 psi on body tissue. A plurality of different pressure contour zones may include an inner cutting zone; a rapid response zone adjacent to the inner cutting zone; a tissue fusion zone adjacent to the rapid response zone; and a relief zone adjacent to the tissue fusion zone. The fixing zone may include a knurled or cross-hatched geometric profile. The geometric profile of at least one of the different pressure contour zones may be non-uniform and non-linear. The cutting zone may include an angled cutting pressure profile. The annular shape may be polygonal or circular. At least one magnetic member may include a plurality of magnetic members assembled into an annular shape, or may include a single magnetic member forming an annular shape.

[0011] In other embodiments, the system may include a first magnetic compression stapling device and a second magnetic compression stapling device of the type described above, wherein the second magnetic compression stapling device is configured to engage with the first magnetic compression stapling device. The first device and the second device may have the same pressure profile configuration, or may have different but complementary pressure profile configurations.

[0012] Additional implementations may be disclosed and claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The patent or application file contains at least one drawing executed in color. Copies of the patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.

[0014] Those skilled in the art will more fully appreciate the advantages of the various embodiments of the present invention from the following “Detailed Description” discussed with reference to the accompanying drawings summarized immediately below.

[0015] 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.

[0016] Figure 2A The magnet assembly is shown having been delivered and deployed to adjacent tissue.

[0017] Figure 2B Two magnet assemblies are shown coupled together by magnetic attraction, thereby capturing intervening tissue. In some cases, an endoscope can be used to cut through circumscribed tissue.

[0018] 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.

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

[0020] Figure 4B Another embodiment is shown for delivery using two upper endoscopes that share each port for delivery of the magnet assembly.

[0021] Figure 5 Another embodiment of the delivery of magnet assemblies sequentially delivered using a single endoscope is shown.

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

[0023] Figure 7 The creation of a preliminary anastomosis is shown to serve as a conduit for deeper endoscopic delivery to create subsequent multiple anastomoses.

[0024] Figure 8 The delivery of a laparoscopic magnet device into a cavity, in this example the stomach, is shown.

[0025] Fig.9A An endoscopic ultrasound guided needle is shown delivering a magnet assembly into the gallbladder which is then connected to the Fig. 9B A second magnet assembly is shown coupled in the stomach or duodenum.

[0026] Fig.10 Stent deployment between the gallbladder and the stomach or duodenum is shown.

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

[0028] Fig.12 Endoscopic ultrasound-guided needle delivery of a magnet assembly into the bile duct is shown.

[0029] Fig.13 Shown is a magnet assembly delivered into the bile duct via endoscopic retrograde cholangiography.

[0030] Fig.14 The coupling of an intra-biliary magnet assembly to a second magnet assembly deployed in the stomach (A) or duodenum (B) is shown.

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

[0032] Fig.16 A magnetic stent that can be delivered into the pancreatic duct is shown. The stent can be coupled to a magnet in the stomach (A) or duodenum (B) to create a draining anastomosis of the pancreatic duct.

[0033] Fig.17 A magnetic assembly is shown being delivered into the peri-pancreatic aggregates (dashed structure) using endoscopic ultrasound guided needle / catheter delivery which is then coupled with a second magnet assembly deployed in the stomach.

[0034] Fig.18 Different targets for anastomosis between the urinary and gastrointestinal systems are shown: renal calyces (A), ureters (B), and bladder (C).

[0035] Fig.19 An assembly of magnets in adjacent blood vessels is shown to couple and form a vascular anastomosis.

[0036] Fig. 20 The magnet assembly in different parts of the respiratory system is shown to form anastomoses between adjacent bronchioles.

[0037] Fig.21 An external magnet assembly for creating a surgical stoma for fecal drainage and an internal magnet assembly within the gastrointestinal tract are shown.

[0038] Fig. 22 A compression anastomotic device with a varying pressure profile is schematically shown.

[0039] Fig.23 A cross section of a compression anastomotic device having a varying geometric profile is schematically shown.

[0040] Fig.24 Cross-sections of various geometric pressure profiles are schematically shown.

[0041] Fig.25 Various reciprocating pressure profiles of two compression anastomotic devices are schematically shown.

[0042] Fig.26 The reciprocating geometric profiles of two compression anastomotic devices are schematically shown.

[0043] Fig. 27 The overlapping geometry of two compression stapling devices across tissue segments is schematically shown.

[0044] Fig.28 A compression anastomotic device having a non-uniform / non-linear geometry is schematically illustrated.

[0045] Fig.29 A compression stapling device having a knurled and cross-hatched pattern is schematically shown.

[0046] Fig.30 A compression stapling device with a cutting pressure profile is schematically shown.

[0047] Fig.31 A close-up view of a mating compression stapling device is schematically shown.

[0048] Fig.32 A compression anastomotic device having one or more alternating pressure profile zones is schematically illustrated.

[0049] Fig.33 A compression anastomotic device having two or more alternating pressure profile zones is schematically illustrated.

[0050] Fig.34 A cross section of a compression anastomotic device having a varying geometric profile is schematically shown.

[0051] Fig.35 A compression anastomosis system with an insulating sheath is schematically shown.

[0052] It should be noted that the aforementioned figures and the elements depicted therein are not necessarily drawn to consistent scale or any scale. Unless the context indicates otherwise, the same elements are indicated 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

[0053] Various embodiments of the present invention include compression anastomosis devices having a variable geometric profile on the surface of the device. The anastomosis device may include a plurality of magnetic connection members arranged in an annular geometry (e.g., polygonal or circular). The anastomosis device may also be a continuous, non-segmented magnet or other compression anastomosis device. The compression anastomosis device is deployed into a human body cavity at a target site via, for example, an endoscope and / or a laparoscope. A second compression anastomosis device is placed at an adjacent target site in an adjacent cavity. The compression anastomosis devices are combined together and, for example, magnetically matched to form an anastomosis.

[0054] The tissue engaging surface of the compression stapling device has a varying geometric profile on the surface of the device to allow for varying pressures to be applied to the tissue being stapled. For example, the outer diameter of the device may 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 penetrate the tissue. This allows for a more robust stapling and greater patient success.

[0055] Fig. 22 An embodiment of a variable pressure profile compression stapling device 100 is shown in FIG. One or more faces of the compression stapling device have variable geometric profiles on the surface of the device, each profile being capable of applying a different pressure on a tissue site.

[0056] like Fig.23 As shown, each compression stapling device may have a varying geometric profile on the surface of the device including one or more contoured areas. The contoured areas may include, but are not limited to, the following:

[0057] - Capable of applying a relief profile of 0 to 25 psi on a tissue site. This profile gradually increases pressure along the contour to allow for a smooth transition between healthy and necrotic tissue.

[0058] - Capable of applying a tissue fusion profile of 25 to 250 psi on the tissue site. This profile applies the required pressure to prevent interstitial fluid exchange over the compressed anastomotic device and cause tissue necrosis and formation of a collagen seal.

[0059] - A quick release profile capable of applying 250 to 40,000 psi on the tissue site. This profile applies the required pressure to release the anastomotic device at the borderline where the pressure is at its peak.

[0060] - Capable of applying a 40,000 to 75,000 psi cutting profile on a tissue site. This profile applies the required pressure to perforate one or more tissue segments.

[0061] Fig.24 Schematically illustrates a cross section of a compression anastomosis device with varying geometric profiles. The geometric profiles may include but are not limited to Fig.24 The force and area of ​​the pressure profile zone determine which of the four zones the geometric profile falls under. The geometric profile zones may include, but are not limited to, a relief zone (0-25 psi), a tissue fusion zone (25-250 psi), a rapid release zone (250-40,000 psi), and / or a cutting zone (40,000-75,000 psi). For a compression anastomosis device, the maximum available force in the system combined with the geometric profile determines the pressure.

[0062] Fig.25 (A) to Fig.25 (C) schematically shows various reciprocating pressure profiles in two compression anastomotic devices. Fig.25 As shown in (A), one compression stapling device includes a changing geometric pressure profile across the device surface, and the second compression stapling device has a reciprocating geometric profile. This allows the two stapling devices to mate with each other and form a compression stapling. The gap between the mating profiles can vary based on the geometry or mating intent. The components of the two mating compression stapling devices help capture the tissue between its features to reduce the slippage of the tissue. When mating two reciprocating compression stapling devices, the changing geometric profile across the device surface allows the two devices to self-position and mate, thereby producing an anastomosis.

[0063] Fig.26 The schematic diagram shows the reciprocating geometric profile between two compression anastomotic devices. The two reciprocating devices cooperate across the tissues in adjacent human cavities, overlapping their geometric shapes to facilitate the creation of an incision. Fig.26 As shown, the cutting profile of the left stapling device overlaps the inner diameter of the right magnet, allowing the incision to be created once a certain compression distance is reached.

[0064] Fig. 27 (A) to Fig. 27(B) schematically shows two mating compression anastomosis devices with tissue between the devices. The overlapping geometry of the compression anastomosis devices allows tissue to be released immediately within the inner diameter of the device, allowing immediate nutrition and fluid passage. This is combined with the formation of a sealed anastomosis to complete.

[0065] Fig.28 A non-limiting example of a compression stapling device comprising a non-uniform / non-linear pattern along the face of the device is schematically shown. The non-uniform pattern may contain one or more of the above-mentioned pressure contour areas. The shape and size of the non-uniform / non-linear pattern are defined by the pressure contour areas.

[0066] Fig.29 (A) to Fig.29 (B) schematically shows a knurled pattern ( Fig.29 (A)) and cross-hatching pattern ( Fig.29 These patterns and other patterns not shown help to secure tissue and prevent slippage when the compression stapling device is secured to the anastomotic site.

[0067] Fig.30 (A) to Fig.30 (B) schematically shows a compression stapling device including an angled cutting pressure profile on the face of the device. When two compression stapling devices are mated ( Fig.30 (A)), the cutting contours overlap ( Fig.30 (B) ), resulting in tissue shearing and detachment, allowing immediate nutrient and fluid passage through the anastomosis.

[0068] Fig.31 A close-up view of a mating compression stapling device is schematically shown. The device has a reciprocating geometry, allowing the angled cutting pressure profiles to interlock. Design features include, but are not limited to, tapered cutting profiles that allow the devices to overlap. The geometry of the overlapping compression stapling device allows shearing of tissue and immediate nutrient and fluid passage through the resulting anastomosis.

[0069] Fig.32 A compression anastomotic device comprising one or more alternating pressure contour zones is schematically illustrated. Fig.33 A compression stapling device including two or more pressure contour zones having a geometric shape is shown. These configurations allow the compression stapling device to provide one or more functions, such as but not limited to relief, tissue fusion, rapid release and / or cutting. This may include but is not limited to the contour zones shown.

[0070] Fig.34A cross section of a compression stapling device including a cutting profile, tissue fusion and a quick release profile is schematically shown. The cutting pressure profile is gradually smoothed into a tissue fusion and / or quick release profile. This allows the compression stapling device to pierce the tissue segment, driving the compression stapling device closer to each other to produce anastomosis.

[0071] Fig.35 (A) to Fig.35 (C) schematically shows a compression stapling device including an insulating sheath that allows energy to be applied to the device. The insulating sheath is placed within the compression stapling device. After the device is engaged across the tissue ( Fig.35 (A)), the energy applicator can be used to create a central incision ( Fig.35 (B) and Fig.35 (C)). Compression of the anastomotic device holds the tissue in place so that the device does not shift when cautery is applied. Utilizing an energy applicator to create a central incision allows for immediate nutrient and fluid passage through the anastomosis.

[0072] It should be noted that self-assembling magnetic anastomosis addresses several historical shortcomings of conventional anastomosis, such as allowing surgical quality anastomosis to be performed in a minimally invasive manner using a device that reproducibly reassembles into a predetermined shape in vivo. The constraints imposed by the described embodiments are designed to allow the device to consistently self-assemble into the correct shape when deployed, which greatly reduces the risk of surgical complications due to deforming the wrong device or premature disengagement, and also reduces the risks associated with surgical access and ensures that the anastomosis is formed with the correct geometric properties. Overall, this ensures the patency of the anastomosis.

[0073] Thus, as described herein, embodiments include a flexible linear magnetic device comprising linked magnetic multipole segments that self-assemble when extruded from the end of a deployment channel or cavity to form a rigid multipole polygonal ring magnet (PRM; generally a "magnetic device"). The self-assembly is guided by the construction of magnets, rollers, flexure elements, and vertebral skins that 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 intensifying attractive magnetic interaction that produces coupling between the magnetic devices. In some examples, the complementary devices must be pre-aligned, however, in other examples, the devices self-align by undergoing 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.

[0074] 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 the anastomosis to be formed without further intervention. When the paired devices are left alone, the compressive force against 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 a formed anastomosis. This cascade begins when the devices approach a "capture range," whereby their mutual attraction is sufficient to align the devices, capture intervening tissue, and resist the natural flexibility of the tissue and tissue movement under normal physiological function.

[0075] 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., as defined by the desired anastomosis size and instrument channel), the thickness of the target tissue, and the inner diameter of the guide channel and the minimum radius of curvature through which the guide channel can bend and the magnet must pass. Once the design specifications are selected, the corresponding magnetic device design can be determined, such as the polygon side count and length, and the maximum lateral dimensions of the flexible linear magnetic structure to be deployed by the delivery instrument.

[0076] The device 100 is usually deployed in Figure 1 . When used with the techniques described herein, if the device is deployed as a complete assembly, the device allows a larger magnetic structure to be delivered via a small delivery catheter (such as in a standard endoscope) than would otherwise be possible. The larger magnet structure in turn allows for a stronger, larger anastomosis and greater surgical success. Because magnetic devices are typically radiopaque and echogenic, the device can typically be positioned using fluoroscopy, direct visualization (transillumination or tissue indentation), and ultrasound (e.g., endoscopic ultrasound). The device can also be decorated with radiopaque paint or other markings to help identify the polarity of the device during placement. In some embodiments, the device can be positioned using a sensor (e.g., using a reed switch or a Hall effect sensor) that is located near the delivery lumen and is capable of sensing the position of the mating device.

[0077] Usually, if Figure 2A As shown, a magnetic anastomosis procedure involves placing a first magnetic structure and a second magnetic structure adjacent to target tissue, thereby bringing the tissue together. The magnetic devices are typically deployed so that the opposing 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 deployed 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 defined 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 annular 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 circular, elliptical, square, hexagonal, octagonal, decagonal or other geometric structures that produce closed loops. As needed, the device can additionally include a handle, a suture loop, a barb and a projection to achieve the desired performance and make delivery (and removal) easier.

[0078] As described with respect to the accompanying drawings, the self-assembling magnetic anastomosis device can be placed with a variety of techniques (such as endoscopy, laparoscopy) or with a catheter (e.g., without direct visualization, fluorescence, etc.). Regardless of the method of device delivery, it is important to note that after confirming that the magnet is connected, the operation for producing 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 a natural opening between the tissues. The fused magnet can be allowed to be naturally discharged, or the magnet can be retrieved in a subsequent surgical operation. Alternatively, if an immediate bypass is required, the tissue surrounded by the magnet can be cut or perforated. Perforation can be achieved by various techniques, such as cauterization, microsurgery, or balloon expansion of the tissue after the needle and guide wire enter.

[0079] In some embodiments, the self-assembled magnetic device is used to form a bypass in the gastrointestinal tract. Such a bypass can be used to treat cancerous obstructions, weight loss or bariatrics, or even to treat diabetes and metabolic diseases (i.e., metabolic surgery). Such a bypass can be created by endoscopy, laparoscopy, or a combination of the two. Figure 3 A variety of gastrointestinal anastomotic targets that can be addressed with the device of the present invention are shown: stomach-small intestine (A), stomach-large intestine (E), small intestine-small intestine (C), small intestine-large intestine (B), and large intestine-large intestine (D). In an endoscopic procedure, two simultaneous endoscopes can be used to deliver the self-assembling magnetic device, for example, an upper endoscope or enteroscope in the upper small intestine, and a colonoscope in the lower small intestine, such as Figure 4A Alternatively, Figure 4B As shown, the device can be placed 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 a first deployment position and a second deployment position. For example, in Figure 4A In this study, a single per-mouth endoscope can deliver and deploy a self-assembling magnet in the small intestine, withdraw it, and then deploy a second complementary magnet in the stomach. Again, fluoroscopy can be used to confirm magnet coupling. Figure 5Removal of a single endoscope after placement of two magnetic devices is shown.

[0080] Various techniques can be used to detect the first deployed magnetic device to assist in the placement of the second mating structure. Once the first device is deployed at the desired anastomotic location, 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 anastomosis formation. Ideally, the devices can be roughly located within a few centimeters of each other (for example, using ultrasound), at which point 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 an endoscope in an adjacent lumen produces a displacement seen by another endoscope in an adjacent lumen. The displacement identifies the potential intersection of the anastomotic location. For example, a magnetic deployment tool (described below) will be deflected by the presence of a deployment device on the other side of the tissue wall.

[0081] A second localization technique involves transillumination, whereby high intensity light from one endoscope is directed toward 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. This light indicates a potential intersection anastomosis point. A cap 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 pair with the end of the endoscope. In some embodiments, the system may include an endoscope with a sensor and a magnetic anastomosis device for deployment using the endoscope.

[0082] The third positioning technique involves magnetic sensing technology to determine the proximity of deployed ring magnets in adjacent cavities. By maximizing the sensed magnetic field, the minimum distance between adjacent channels can be identified. The magnetic sensor can be carried on a probe inserted along the working channel of the endoscope and utilizes common magnetic sensing technology such as Hall effect sensors or reed switches.

[0083] Additional accessories may also aid in delivering the magnetic device to the precise anastomotic site using transillumination and magnetic sensing. A radially expandable ring structure may be deployed with an endoscope or laparoscope that may be press fit and seat itself on the outer diameter of the endoscope. The outer diameter of the expansion element is sized to allow the deployed device to seat itself on the expansion element (again, a press fit may be possible). With the expansion element and magnetic device radially positioned about the endoscope axis, the endoscope may be guided to the desired anastomotic location by direct contact, transillumination, or magnetic sensing, and then release the mating magnetic device when the anastomotic site is identified.

[0084] 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 approach the small intestinal target and deliver the self-assembled magnet into the small intestinal lumen. Delivery can be guided by fluoroscopy or endoscopic ultrasound. After self-assembly, these small intestinal 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 with an endoscope and the second device with a needle, or vice versa.

[0085] exist Figure 7 In another embodiment shown, a first anastomosis formed in an 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 gastrojejunostomy (stomach to mid-small intestine) can be used as a conduit for creating a second, more distal gastrojejunostomy. Ultimately, in this particular case, the stomach will have several bypasses to the small intestine. Additionally, in some cases, more anastomoses can be added to "titrate" for a specific clinical effect (e.g., lower glycosylated hemoglobin in type 2 diabetes). In alternative embodiments, anastomoses can be placed to provide access for different types of surgeries (e.g., tumor removal).

[0086] 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 create an anastomosis, such as Figure 8 Likewise, the procedure may be directed to fluoroscopy or ultrasound, and the procedure may be purely laparoscopic, or a combination of endoscopic and / or laparoscopic and / or needle surgery.

[0087] Gastrointestinal anastomosis can be used to address a variety of 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 surgery 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 formed to bypass pathological, poorly formed or dysfunctional tissue. In some embodiments, 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.

[0088] Using a self-assembling magnetic device as discussed herein, a side-to-side anastomosis that does not require the exclusion of intermediate tissue, as is common in prior art obesity surgery, can be produced. That is, using the device of the present invention (or other devices for producing anastomosis), an alternative path as a partial bypass of liquids (e.g., gastric juice) and nutrients (e.g., food) can be produced while maintaining at least a portion of the old path. The design allows the ratio of "normal" to "modified" digestion to be adjusted based on the goals of the surgery. In other words, using the described process, the doctor can choose the ratio of food / liquid shunted along the new (partial) bypass to the food / liquid shunted along the old path. In most cases, the portion shunted along the bypass branch will drive the patient toward the desired clinical endpoint (e.g., weight loss, improvement of glycosylated hemoglobin, improvement of lipid profile, etc.). The mechanism for achieving these endpoints can involve early delivery of large amounts of nutrients to the ileum, stimulating L cells, and, for example, increasing the production of GLP-1. The mechanism can also involve the loss of efficiency of nutrient absorption (especially glucose), thereby reducing blood sugar levels. At the same time, however, the portion of diversion along the old pathway prevents known metabolic complications that may be associated with bariatric surgery, such as excess weight loss, adverse diarrhea, electrolyte dieback, malnutrition, and the like.

[0089] To achieve a desired bypass ratio (e.g., redirecting food and secretions to flow along a new path, say 70% or 80% or 90% or 100% of the time), the size, location, and possibly number of anastomoses will be important. For example, for a gastrojejunal anastomosis, it may be critical to place the anastomosis in a gravity-dependent manner to take advantage of gravity. Also, instead of a circular anastomosis, a long, oval anastomosis may be better formed to maximize anastomosis size. 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 place one or more anastomoses as needed to achieve the desired clinical endpoint. For example, Figure 4A and Figure 4B The two endoscopic procedures shown can be used to create a partial bypass of a portion of the intestine. Based on the desired ratio of bypassed nutrients to 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 placed to achieve the desired ratio.

[0090] 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 yet another anastomosis. Alternatively, the state may be partially reversed by closing one or more anastomoses. Because the partially bypassed tissues are not removed, they can return to almost normal function, pass a greater amount of nutrients, etc. 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 passing through the "normal" pathway. 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, it is possible to generally and tunably create a partial bypass or a series of partial bypasses between portions of the intestine to achieve a clinical endpoint, such as, for example, Figure 3 Described in .

[0091] The described surgery can also be used in conjunction with surgery to remove or block the bypassed tissue, as is common with obesity surgery. For example, a gastrojejunostomy can be coupled with a pyloric plug (gastric obstruction) or another closure of the pylorus (e.g., a sutured closure) to shunt food completely downward to the new bypass. Such surgery can be used, for example, to bypass tissue that is diseased, for example, due to cancer.

[0092] In another type of surgery, endoscopic ultrasound (EUS) can be used to facilitate guided transgastric or transduction access to the gallbladder to place a self-assembling magnetic anastomotic device. Once gallbladder access is obtained, various strategies can be used to maintain patient access between the stomach and gallbladder or the duodenum and gallbladder. In another embodiment, gallstones can be retrieved and fluid drained through an endoscope. For example, using the method, an anastomosis can be formed between the gallbladder and the stomach. Once the gallbladder is accessed transgastricly or transduced, the gallstones can be removed. In addition, the gallbladder mucosa can be ablated using any number of modalities, including but not limited to argon plasma coagulation (APC), photodynamic therapy (PDT), sclerosants (e.g., ethanolamine or ethanol).

[0093] One strategy for creating a portal is to deploy self-assembling magnets via an endoscopic needle under ultrasound guidance into the gallbladder and also into the stomach or duodenum. These magnets will mate and form a compression anastomosis or fistula. A second strategy for creating a portal 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 necrotized and anastomosed.

[0094] 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 functionality. For example, a stent can be deployed between tissues such as the gallbladder and the stomach, such as Fig.10 Alternatively, the gallbladder magnet can be coupled to a balloon-based device filled with air, liquid, magnetic members or magnetic particles. When inflated, the balloon will serve as an anchor in the bile duct after placement. The balloon can also have a ring-shaped configuration to allow 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 range of the coupling magnets, i.e., not leaving the path for bile to escape. Otherwise, the opening will allow bile leakage that may lead to peritonitis.

[0095] Another medical application of self-assembled magnets is direct bile duct access. Currently, in order to achieve decompression of malignant bile duct strictures, endoscopic retrograde cholangiography (ERCP) is performed. The bile duct is accessed endoscopically through the papilla in a retrograde manner, and the stent is deployed across the stricture over a guidewire. These stents often require subsequent surgery to replace, remove, or place additional overlapping stents. When using the ERCP procedure, replacement and cleaning are required to offset the high infection rate of the bile duct tree (i.e., cholangitis). Due to the high morbidity, ERCP is usually limited to patients who have no other options for solving pancreatic disease.

[0096] However, using the device of the present invention, anastomosis can be easily formed between the bile duct (preferably, the main bile duct) and the duodenum or stomach (choledo-gastric and choledo-duodenal anastomosis, respectively). The anastomosis is permanent and, if positioned separately from the diseased tissue, generally no intervention is required. In one embodiment, the biliary magnetic device is delivered directly into the bile duct under endoscopic ultrasound guidance. As described below, the self-assembled magnetic device is extruded through a needle or catheter, whereupon it is deployed in the correct configuration. Using fluoroscopy or ultrasound, it can then be confirmed that the device has self-assembled and is in the correct position. In some embodiments, the magnetic device can be tethered to the delivery needle or catheter by a detachable wire or suture to achieve mechanical retraction until optimal positioning is confirmed.

[0097] In one embodiment, the magnetic device can be delivered endoscopically through the duodenal wall to the bile duct, such as 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 needle sticks across tissue planes, such as Fig.12 However, regardless of the method used to deliver the biliary magnet, a second magnetic device is required in the gastric (A) or duodenal (B) lumen, such as Fig.14 As shown. Typically, this decision depends on the patient's anatomy (e.g., the size of the duodenal lumen) and the location of the initial biliary magnet. In the case of endoscopic ultrasound needle-based delivery, the second magnetic device can be connected to the biliary magnet via the aforementioned detachable wire and thus extruded through the same delivery needle / catheter. Alternatively, the second device can be pre-attached to the outside of the endoscope and slid into position for connection after the biliary magnet is deployed. The latter procedure may be more suitable for forward-looking echoendoscopes, but can generally be used with endoscopes.

[0098] In another embodiment, the biliary magnet is a balloon-based device filled with air, liquid, magnetic blocks, or magnetic particles, similar to that previously described for gallbladder surgery. When inflated, the balloon will serve as an anchor in the bile duct after placement. In one embodiment, the balloon may have a ring-shaped configuration to allow for immediate access after coupling with a second magnet. Additionally, similar to the gallbladder surgery described above, the biliary magnetic device can be used with a stent form factor. In one embodiment, a stent has an internal biliary magnet and an articulated external magnet. The stent can be inserted into the bile duct through the ampulla in a retrograde manner. The articulated external magnet can then swing around and couple with the internal biliary magnet to form a fistula between the bile duct and the duodenum, as described above. Fig.15 shown.

[0099] The magnetic device of the present invention may also be used to treat pancreatic disease. For example, the pancreatic duct requires decompression in certain disease states, such as chronic pancreatitis. Currently, extensive pancreatic duct decompression requires surgery (e.g., in which the pancreas is filtered along the axis of the pancreatic duct and connected to a loop of the small intestine for improved pancreatic drainage). As an alternative to breast reduction surgery, extensive pancreatic duct decompression may be achieved by using a magnetic pancreatic duct 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 coupled to a second magnetic device in the stomach or duodenum. As in the biliary scenario described above, the magnetic pancreatic catheter can be hinged to the second magnetic device.

[0100] Self-assembled magnetic devices can also be used to access and drain fluid collections located adjacent to the gastrointestinal tract, e.g. Fig.17 For example, following pancreatitis, a collection of pancreatic fluid may form that requires drainage. While drainage can be achieved using surgery or a percutaneous catheter, endoscopic drainage has been found to be more cost-effective clinically, 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 speed removal after drainage, the first magnet can be tethered by a connecting wire as previously described. As previously described, the intervening tissue can be cut using electrocautery or dilation, followed by needle and wire entry. Additional devices such as magnetically coupled clamps can be used to control blood flow to allow "bloodless" endoscopic access to the aggregate.

[0101] 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 formed between the renal calyx and the intestine (A), between the ureter and the intestine (B), or between the bladder and the intestine (C). As described above, the self-assembled magnetic device of the present invention can be delivered to the urinary tract using an endoscope, laparoscope, or needle. The reciprocating magnetic device can be delivered to the gastrointestinal tract using an endoscope, laparoscope, or needle as described above. In other embodiments, the device can be used in reproductive surgery, such as bypassing a portion of an obstructed fallopian tube or bypassing a vaginectomy.

[0102] In another application, the self-assembled magnetic device can be used to create vascular anastomoses or treat heart disease. For example, the magnetic device can be used to form a magnetic anastomosis connection between adjacent blood vessels, such as Fig.19 In one embodiment, the self-assembled device can be delivered with a vascular delivery device such as a catheter. In addition, as described above with respect to gallbladder and pancreatic applications, a shunt can be installed to bypass a portion of a weak or blocked vasculature.

[0103] 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, a magnetic anastomosis can be created by deploying the self-assembled magnetic device 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.

[0104] The self-assembling magnetic device can also be used to create a surgical procedure to divert 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 secured at skin level. The external magnetic device can be coupled to a third magnetic device that is coupled to the collection device. Such a system allows the collection device to be easily removed for cleaning, etc.

[0105] 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 means 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 for which the present invention is taught. 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 by way of example, and within the scope of the appended claims and their equivalents, embodiments of the present invention may be practiced in a manner different from that specifically described and claimed. The inventive embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, if two or more such features, systems, articles, materials, kits, and / or methods are not inconsistent with each other, any combination of these features, systems, articles, materials, kits, and / or methods is included within the scope of the invention disclosed herein.

[0106] 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.

[0107] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0108] Unless clearly indicated to the contrary, the indefinite articles "a" and "an" as used herein in the specification and claims should be understood to mean "at least one".

[0109] 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.

[0110] 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 multiple elements or lists, but also including more than one, and optionally, additional unlisted items. Only terms that clearly indicate the opposite, such as "only one" or "exactly one", or when used in the claims, "consisting of..." will refer to including exactly one element in multiple elements or lists of elements. Usually, the term "or" as used herein will only be interpreted as indicating exclusive alternatives (that is, "one or the other but not two"), when preceded by exclusive terms, such as "either", "one", "only one" or "exactly one". When used in the claims, "consisting essentially of..." should have its ordinary meaning used in the field of patent law.

[0111] 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 not necessarily including at least one of each element specifically listed within the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows that elements may optionally be present other than those specifically identified within the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or equivalently, "at least one of A or B", or equivalently, "at least one of A and / or B") may refer to at least one, optionally including more than one A, wherein B is absent (and optionally including elements other than B); in another embodiment, may refer to at least one, optionally including more than one B, wherein A is absent (and optionally including elements other than A); in yet another embodiment, may refer 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.

[0112] As used herein in the specification and claims, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "maintaining," "consisting of," and the like shall be construed as open ended, i.e., meaning including, but not limited to, including. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as described in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.

[0113] Without limitation, potential subject matter that may be claimed (prefaced with the letter "P" to avoid confusion with the actual claims presented below) includes:

[0114] P1. An apparatus for producing a compression anastomosis, wherein the apparatus comprises a compression anastomosis device having an annular shape and a top surface parallel to a diameter of the compression anastomosis device, and wherein the top surface comprises one or more geometric contours.

[0115] P2. An apparatus according to any previous innovation, wherein the apparatus further comprises: a second compression anastomosis device, wherein the second compression anastomosis device has an annular shape and a second top surface parallel to a diameter of the second compression anastomosis device, the second top surface comprising one or more geometric contours, wherein the one or more geometric contours of the second top surface are complementary to the one or more geometric contours of the first top surface.

[0116] P3. A device according to any previous innovation, wherein the geometric profile is capable of producing a relief profile of 0-25 psi on body tissue.

[0117] P4. An apparatus according to any previous innovation, wherein the geometric profile is a tissue fusion profile capable of producing 25-250psi on body tissue.

[0118] P5. An apparatus as described in any previous innovation, wherein the geometric profile is a quick release profile capable of producing 250-40,000 psi on body tissue.

[0119] P6. An apparatus according to any previous innovation, wherein the geometric profile is a cutting profile capable of producing 40,000-75,000 psi on body tissue.

[0120] P7. The apparatus of any previous innovation, further comprising: a plurality of connecting members arranged in an annular configuration, the plurality of connecting members comprising one or more geometric profiles.

[0121] P8. An apparatus according to any previous innovation, wherein the apparatus further comprises: a second plurality of connecting members arranged in a ring configuration, wherein the second plurality of connecting members comprises one or more geometric profiles, wherein the one or more geometric profiles of the second plurality of connecting members are complementary to the one or more geometric profiles of the first plurality of connecting members.

[0122] P9. An apparatus according to any previous innovation, wherein the geometric profile is non-uniform and non-linear.

[0123] P10. An apparatus according to any previous innovation, wherein the geometric profile is knurled and / or cross-hatched.

[0124] P11. An apparatus according to any previous innovation, wherein the geometric profile is an angled cutting pressure profile.

[0125] P12. An apparatus according to any previous innovation, wherein the geometric profiles of the first plurality of connecting members and the second plurality of connecting members overlap.

[0126] P13. The apparatus of any preceding innovation, wherein the plurality of connecting members comprises one or more alternating contour regions.

[0127] P14. The apparatus of any previous innovation, wherein the plurality of connection members comprises two or more contoured regions having a geometric shape.

[0128] P15. A device according to any previous innovation, further comprising: an insulating sheath capable of allowing energy to be applied to the device.

[0129] 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 "present 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 are to be considered in all respects merely illustrative and not restrictive.

Claims

1. A magnetic compression anastomosis device, comprising: At least one magnetic member is formed into an annular shape, and the at least one magnetic member includes a tissue engaging surface, and the tissue engaging surface includes a plurality of different pressure contour areas selected from the group consisting of: a cutting area, a quick release area, a tissue fusion area, a relief area, and a fixation area.

2. The device according to claim 1, wherein: The relief zone is capable of generating a pressure between about 0 psi and about 25 psi on body tissue; The tissue fusion zone is capable of generating between about 25 psi and about 250 psi on the body tissue; The rapid release zone is capable of producing between about 250 psi and about 40,000 psi on body tissue; and The cutting zone is capable of producing between about 40,000 psi and about 75,000 psi on body tissue.

3. The device according to claim 1, wherein: The plurality of different pressure profile areas include: Inner cutting area; a fast response zone, the fast response zone being adjacent to the inner cutting zone; a tissue fusion zone, the tissue fusion zone being adjacent to the rapid response zone; and A relief zone is adjacent to the tissue fusion zone.

4. The device according to claim 1, wherein: The securing area has a knurled or cross-hatched geometric profile.

5. The device according to claim 1, wherein: The geometric profile of at least one of the different pressure profile regions is non-uniform and non-linear.

6. The device according to claim 1, wherein: The cutting zone includes an angled cutting pressure profile.

7. The device according to claim 1, wherein: The annular shape is a polygon.

8. The device according to claim 1, wherein: The annular shape is a circle.

9. The device according to claim 1, wherein: The at least one magnetic member includes a plurality of magnetic members assembled in a ring shape.

10. The device according to claim 1, wherein: The at least one magnetic member is a single magnetic member forming the annular shape.

11. A system, comprising: a first magnetic compression anastomosis device, wherein the first magnetic compression anastomosis device is the magnetic compression anastomosis device according to claim 1; as well as A second magnetic compression anastomosis device, wherein the second magnetic compression anastomosis device is the magnetic compression anastomosis device according to claim 1, and the second magnetic compression anastomosis device is configured to be engaged with the first magnetic compression anastomosis device.

12. The system of claim 11, wherein: The relief zone is capable of generating a pressure between about 0 psi and about 25 psi on body tissue; The tissue fusion zone is capable of generating between about 25 psi and about 250 psi on the body tissue; The rapid release zone is capable of producing between about 250 psi and about 40,000 psi on body tissue; and The cutting zone is capable of producing between about 40,000 psi and about 75,000 psi on body tissue.

13. The system according to claim 11, wherein: The plurality of different pressure profile areas of at least one of the first device or the second device comprises: Inner cutting area; a fast response zone, the fast response zone being adjacent to the inner cutting zone; a tissue fusion zone, the tissue fusion zone being adjacent to the rapid response zone; and A relief zone is adjacent to the tissue fusion zone.

14. The system according to claim 11, wherein: The securing area has a knurled or cross-hatched geometric profile.

15. The system according to claim 11, wherein: The geometric profile of at least one of the different pressure profile regions is non-uniform and non-linear.

16. The system according to claim 11, wherein: The cutting zone includes an angled cutting pressure profile.

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

18. The system of claim 11, wherein: The annular shape is a circle.

19. The system of claim 11, wherein: The at least one magnetic member includes a plurality of magnetic members assembled into the annular shape.

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

21. The system of claim 11, wherein: The first device and the second device have the same pressure profile configuration.

22. The system of claim 11, wherein: The first device and the second device have different but complementary pressure profile configurations.

Images