Systems, apparatus, and methods for endoscopic or laparoscopic magnetic navigation

Abstract

The present invention provides systems, devices and methods for delivering, deploying and positioning a magnetic compression device at a desired site, thereby improving the accuracy of anastomosis formation between tissues, organs and the like.

Description

Technical Field

[0004] , ,

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 177162, filed on April 20, 2021, entitled SYSTEMS, DEVICES, AND METHODS FOR ENDOSCOPE OR LAPAROSCOPIC MAGNETIC NAVIGATION (Attorney Docket No. 121326 - 11501), which is incorporated herein by reference in its entirety.

[0002] The subject matter of this patent application may be related to the subject matter of U.S. Patent Application No. 17 / 108840, filed on December 1, 2020, entitled SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES (Attorney Docket No. 121326 - 11101). U.S. Patent Application No. 17 / 108840 is a partial continuation application of International Patent Application No. PCT / US2019 / 035202, having an international filing date of June 3, 2019 (Attorney Docket No. 121326 - 11102), and thus claims its priority. International Patent Application No. PCT / US2019 / 035202 claims the benefit and priority of U.S. Provisional Application No. 62 / 679810, filed on June 2, 2018, U.S. Provisional Application No. 62 / 798809, filed on January 30, 2019, and U.S. Provisional Application No. 62 / 809354, filed on February 22, 2019. The contents of these are each incorporated herein by reference in their entirety.

[0003] Technical Field The present invention relates to a deployable magnetic compression device, and more particularly, to a system, device, and method for delivering, deploying, and positioning a magnetic compression device at a desired site, thereby improving the accuracy of anastomosis formation between tissues, organs, etc.

[0004] Background Art Bypasses in the gastrointestinal (GI), cardiovascular, or urinary tract are typically formed by perforating two tissues and connecting these holes with sutures or staples. The bypass is typically placed to allow fluids (e.g., blood, nutrients) to pass between relatively healthy parts of the system, while bypassing diseased or dysfunctional tissue. The procedure is typically invasive and exposes the patient to risks such as bleeding, infection, pain, and side effects of anesthesia. Additionally, bypasses formed with sutures or staples can lead to complications such as postoperative leakage and adhesion. Leakage can result in infection or sepsis, while adhesion can result in complications such as bowel strangulation or bowel obstruction. While conventional bypass procedures can be completed using endoscopy, laparoscopy, or robotics, connecting the perforated tissues can be time-consuming. Furthermore, such procedures require specialized skills and equipment that are not available in many surgical facilities.

[0005] Instead of sutures or staples, surgeons can use mechanical couplings or magnets to form a compression anastomosis between tissues. For example, a pair of compression couplings or magnets can be sent to the tissues to be joined. Due to the strong compression, the tissue trapped between the coupling or magnets is separated from its blood supply. Under these circumstances, the tissue becomes necrotic and degenerates, while new tissue grows around the compression point, for example, at the edges of the coupling. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0006] Nevertheless, the placement of magnets or couplings is difficult, limiting the locations where compression anastomoses can be used. In most cases, magnets or couplings must be delivered as two separate assemblies, requiring either an open surgical field or 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 relatively small structures are used, the resulting anastomose is small and suffers from short-term patency. Furthermore, the placement of magnets or couplings can be inaccurate, which may lead to anastomosis formation in undesirable or incorrect locations.

[0007] Therefore, there remains a clinical need for reliable devices and minimally invasive procedures that facilitate the formation of compression anastomoses between tissues within the human body.

[0008] overview Various embodiments of the present invention provide improved devices and techniques for minimally invasively forming anastomoses within the body. Such devices and techniques facilitate faster and less expensive treatment for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative care for diseases such as cancer.

[0009] For example, in some embodiments, the device for capturing and operating a compression anastomosis device includes a cap, which is configured to be attached to a feeding device by a pivot cap plate coupled to the distal end of the cap body. In some embodiments, the cap plate may be movable between a closed position and a fully open position. Various embodiments may include one or more capturing devices in the cap plate configured to capture a magnetic anastomosis device.

[0010] Various embodiments of the present invention may include a cap plate substantially angled with respect to the feeder. The fully open cap plate may be swung away from the angled distal end of the feeder. Some embodiments may include a capture device having a magnet. In some embodiments, the magnet may be an electromagnet that provides a constant and / or variable magnetic field strength for capturing, holding, and releasing the compression anastomosis device.

[0011] In some embodiments, the capture device may be able to grasp or hold the magnetic anastomosis device. The capture device may include one or more adhesion devices.

[0012] Various embodiments include a cap plate that can be coupled to a cap body using at least one pivoting means, in which case the pivoting means may include one or more pins and / or one or more hinges and / or one or more ball joints.

[0013] In some embodiments, the cap may include a biasing system that biases the cap plate toward the closed position. The biasing system may include one or more springs.

[0014] In some embodiments, the closed position of the cap plate may be approximately 45° or less with respect to the reference plane of the feeder. The fully open position may be 90° or more with respect to the reference plane of the feeder.

[0015] In some embodiments, the cap plate may include an extension that, when pressure is applied to the extension, moves the cap plate from a closed position to a fully open position. The cap plate may be configured to move from a closed position to a fully open position when a sufficient magnetic interaction force exists between the magnetic anastomosis device captured by the cap plate and the opposing magnetic anastomosis device.

[0016] Various embodiments may include an operating mechanism for remotely controlling the position of the cap plate relative to the cap body, in which case the operating mechanism may include a spring load mechanism that can release the cap plate from a closed position to a fully open position. Various embodiments may also include an operating mechanism for remotely controlling the position of the cap body relative to the feed device.

[0017] In some embodiments, the cap body is movable relative to the feed device. The cap body may include universal joints, hinges, and / or ball joints that are movable relative to the feed device.

[0018] In some embodiments, the cap may include at least one sensor that detects the position of the cap body and provides feedback to the user.

[0019] The cap may be formed of a substantially transparent material to allow visibility of the cap. The cap plate may have a larger diameter than the diameter of the cap body. The cap body may include one or more channels extending through the cap body.

[0020] In some embodiments, at least one channel is adapted to allow fluid and / or air to pass through the cap body, at least one passage is adapted to allow an instrument to pass through the cap body, at least one passage is adapted to allow visibility through the cap body, and / or at least one passage is adapted to deliver a suction means through the cap body.

[0021] Various embodiments include at least one capture device, which is configured to automatically release the captured magnetic anastomosis device if the captured magnetic anastomosis device is properly coupled to the opposing magnetic anastomosis device, and to hold the captured magnetic anastomosis device if the captured magnetic anastomosis device is not properly coupled to the opposing magnetic anastomosis device.

[0022] In some embodiments, the delivery device is attached to the cap. In some embodiments, the delivery device may be an endoscope, a laparoscope, or a catheter.

Brief Description of the Drawings

[0023] The features and advantages of the claimed subject matter will become apparent from the following detailed description of embodiments that coincide with them, which description is discussed with reference to the accompanying drawings. [Figure 1] It is a schematic diagram of an anastomosis formation system consistent with the present disclosure. [Figure 2] It is a diagram showing some potential anatomical targets for anastomosis formation, where 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 3] It is a diagram showing an exemplary magnetic anastomosis device sent through an endoscopic instrument channel so that individual magnet segments self-assemble to form a larger magnetic structure, in this particular case an octagon. [Figure 4A] It is a diagram showing two magnetic anastomosis devices attracting each other through tissue. As shown, the devices each have eight magnetic segments, although alternative configurations are possible. When the two devices are joined, the tissue trapped between the devices will necrose, giving rise to the anastomosis to be formed. Alternatively, the tissue joined by the devices may be perforated after the devices are joined, whereby an anastomosis may be formed immediately. [Figure 4B] It is a diagram showing two magnetic anastomosis devices that are joined by magnetic attraction and capture intervening tissue. In some examples, an endoscope may be used to cut the enclosed tissue. [Figure 5A] It is a diagram showing a needle for sending a first magnetic device to a target site within a first portion of a hollow body. [Figure 5B] It is a diagram showing where a second magnetic device has been deployed within a second portion of the hollow body adjacent to the target site. [Figure 6]FIG. 6A shows the delivery of a magnet assembly into the gallbladder by an ultrasound endoscope-guided needle, which then couples with a second magnet assembly in the stomach or duodenum as shown in FIG. 6B. [Figure 7] It is a diagram showing a single guide member for deploying and operating a magnetic anastomosis device. [Figure 8A] It is a diagram showing the deployment of a self-closing magnetic anastomosis device provided with a plurality of guide members. [Figure 8B] It is a diagram showing the deployment of a self-closing magnetic anastomosis device provided with a plurality of guide members. [Figure 8C] It is a diagram showing the deployment of a self-closing magnetic anastomosis device provided with a plurality of guide members. [Figure 8D] It is a diagram showing the deployment of a self-closing magnetic anastomosis device provided with a plurality of guide members. [Figure 8E] It is a diagram showing the deployment of a self-closing magnetic anastomosis device provided with a plurality of guide members. [Figure 8F] It is a diagram showing the deployment of a self-closing magnetic anastomosis device provided with a plurality of guide members. [Figure 9] FIGS. 9, 10, 11, and 12 show various methods of accessing a target site, specifically various methods of accessing the gallbladder by ultrasound endoscope-guided procedures. FIG. 9 shows the use of monopolar energy for accessing the gallbladder by puncture. [Figure 10] It is a diagram showing the use of a fine needle aspiration (FNA) for accessing the gallbladder by puncture. [Figure 11] It is a diagram showing the use of a spiral needle for accessing the gallbladder by puncture. [Figure 12] It is a diagram showing the use of a guide wire passed through the bile duct. [Figure 13] It is a diagram showing an ultrasound endoscope-guided needle that punctures the gallbladder to access the inside of the gallbladder and then sends a magnet assembly into the gallbladder. [Figure 14]Figures 14, 15, 16, and 17 illustrate various devices for fixing access devices and / or feeding devices to a target site in the gallbladder, with Figure 14 showing a T-bar member. [Figure 15] This diagram shows a Nitinol coil (for example, a "pigtail"). [Figure 16] This is a diagram showing the balloon component of a catheter. [Figure 17] This is a diagram showing a Malecot catheter. [Figure 18A] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 18B] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 18C] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 18D] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 18E] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 18F] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 19] This is a variation of the design shown in Figures 18A to 18F, specifically, in which a single magnetic anastomosis device is delivered into the gallbladder using a balloon rather than a pair. [Figure 20] Figures 20A, 20B, and 20C illustrate a method for accessing the gallbladder via an ultrasound-guided access means using a high-temperature insertion tube that emits monopolar energy, and then delivering a magnetic anastomosis device into the gallbladder via the high-temperature tube. [Figure 21]Figures 21A, 21B, 21C, 21D, and 21E illustrate the technique of delivering a pair of magnetic anastomosis devices to access the gallbladder and form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 22] Figures 22A, 22B, and 22C illustrate a variation of the procedure and apparatus shown in Figures 21A to 21E, in which the magnetic anastomosis device is pre-loaded into the distal end of the Malecot catheter of the feeding device. As a result, when the Malecot end moves to a fixed position, the device is fed and deployed. [Figure 23] This figure shows a Malecott catheter having a distal end that expands within a fixed position on one side of the gallbladder tissue wall. [Figure 24] This figure shows a Malecott catheter with distal ends that expand within a fixed position on both sides of the gallbladder tissue wall. [Figure 25] Figures 25A, 25B, 25C, 25D, and 25E illustrate the technique of delivering a pair of magnetic anastomosis devices to access the gallbladder and form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue). [Figure 26] Figures 26A, 26B, and 26C illustrate a variation of the procedure and apparatus shown in Figures 25A to 25E, wherein the deployment sheath has a notch at its distal end, which engages with the T-bar as it advances through the intestinal incision, thereby pressing the T-bar laterally and subsequently enabling the feeding and deployment of the magnetic anastomosis device. [Figure 27] Figures 27A, 27B, and 27C illustrate another variation of the procedure and apparatus shown in Figures 25A to 25E, which, rather than having a deployment sheath for advancing the self-assembling magnetic anastomosis device as described herein, rely on depositing T-bars through an access needle, thereby configuring a group of T-bars to self-assemble to form an array and, as a distal anastomosis device, to bond with a proximal magnetic anastomosis device located on the opposite side, and then work to compress the tissue between them to form an anastomosis. [Figure 28] Figures 28A, 28B, and 28C illustrate a method of accessing the gallbladder via an ultrasound-guided access needle access means, utilizing a side-port deployment sheath for advancing and deploying a pair of magnetic anastomose devices. [Figure 29] Figures 29A, 29B, and 29C show a knotting member configured to fix an already deployed and positioned magnetic anastomosis device to the tissue at the target site, and then cut the guide member or suture to which it is attached. [Figure 30] Figures 30A, 30B, 30C, and 30D illustrate the technique for delivering a pair of magnetic anastomosis devices to access the gallbladder and form an anastomosis between gallbladder tissue and adjacent tissue. [Figure 31] Figures 31A and 31B show a set of magnetic segments that are pre-packaged with unstable polarity and include multiple guide members, tethers, or sutures that connect adjacent segments to each other to facilitate self-assembly of the magnetic segments into a polygonal unfolded shape. [Figure 32] Figures 32A and 32B illustrate a method for accessing the gallbladder via an ultrasound-guided access means using an access device having a conductor including a "high temperature" tip that emits monopolar energy, and then delivering the pre-packaged magnetic segments shown in Figures 31A and 31B into the gallbladder through a sheath. [Figure 33] Figures 33A, 33B, and 33C illustrate a method for accessing the gallbladder using an ultrasound-endoscopic guided access means, with the use of a needle to access the gallbladder, and then delivering a rolled stack of magnetic segments configured so that a distal anastomosis device connects to a proximal magnetic anastomosis device located on the opposite side, and then works to compress the tissue between them to form an anastomosis. [Figure 34] Figures 34A and 34B illustrate the technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue. [Figure 35]This figure shows a magnetic anastomosis device that includes a continuous guide member or suture, coupled to multiple magnetic segments of the device via eyelets positioned on each of the multiple magnetic segments. [Figure 36] This figure shows one embodiment of a suture cutting device in a feeding device deployment sheath or secondary device for cutting sutures coupled to a magnetic anastomosis device. [Figure 37] Figures 37A and 37B are enlarged side views showing an anvil / sharpening device and a sharp / sharpening device for cutting sutures. [Figure 38] This figure shows a snare device (secondary device) configured to be inserted over a guide member or suture coupled to a magnetic anastomosis device, and configured to cut the suture or guide member when the magnetic anastomosis device is deployed and positioned at the target site. [Figure 39A] This figure shows a snare device including a resistance heating element for cutting guide members. [Figure 39B] This figure shows a snare device including a ring member having a cutting edge for cutting a guide member. [Figure 39C] This figure shows a snare device including a ring member having a cutting edge for cutting a guide member. [Figure 39D] This figure shows a secondary device configured to cut sutures or guide members using monopolar / bipolar energy. [Figure 40] This figure shows a detachable guide member or suture. [Figure 41] Figures 41A and 41B show a removable suture assembly. [Figure 42] This is a perspective view showing another embodiment of a magnetic assembly consistent with the present disclosure. [Figure 43A] This diagram shows the distal tip of the delivery device being advanced through the tissue walls of adjacent organs at the target site, and then forming an anastomosis between them. [Figure 43B]This is a magnified view of the distal end of the feeder, showing the slots that extend through the side of the feeder's main body. [Figure 43C] This diagram shows the process of sending the first magnetic assembly into the first organ. [Figure 43D] This figure shows the first magnetic assembly being deployed into the first organ while remaining held in the feeder's slot. [Figure 43E] This figure shows the first magnetic assembly, which is fully deployed within the first organ, being pulled towards the wall of the first organ by retracting the feeder in preparation for sending and deploying the second magnetic assembly into the second organ. [Figure 43F] This figure shows the delivery of the second magnetic assembly into the second organ. [Figure 43G] This is a magnified view showing a partial cross-section of the second magnetic assembly as it progresses to the unfolded state. [Figure 43H] This figure shows the first and second magnetic assemblies coupled to each other as a result of the magnetic force attracting them between the first and second magnetic assemblies in a fully deployed state. [Figure 43I] This figure shows the distal end of a feeder, which consists of two halves and is configured to separate, allowing the feeder to be removed from the target site while a pair of magnetic assemblies remain coupled to each other and form an anastomosis at the target site. [Figure 44A] This is a cross-sectional view showing various cross-sections of the magnetic segments of a magnetic assembly within a standard scope's working channel. [Figure 44B] This is a cross-sectional view showing various cross-sections of the magnetic segments of a magnetic assembly within a standard scope's working channel. [Figure 44C] This is a cross-sectional view showing various cross-sections of the magnetic segments of a magnetic assembly within a standard scope's working channel. [Figure 44D] This is a cross-sectional view showing various cross-sections of the magnetic segments of a magnetic assembly within a standard scope's working channel. [Figure 45]This figure shows a list of some exemplary working channel sizes that are considered usable / workable for deploying a cage-equipped magnetic array to form an anastomosis. [Figure 46] This is a schematic diagram showing a laparoscopic anastomosis capture device according to one exemplary embodiment, which has the ability to capture a compression anastomosis device, orient it to a predetermined angle, and allow for easier translation within the lumen. [Figure 47] This is a schematic diagram showing a laparoscopic anastomosis capture device configured to rotate in response to pressure, according to one exemplary embodiment. [Figure 48] This is a schematic diagram showing a laparoscopic anastomosis capture device configured to rotate using guidelines, according to one exemplary embodiment. [Figure 49] This is a schematic diagram showing a laparoscopic anastomosis capture device, including a universal joint that provides additional degrees of freedom, according to one exemplary embodiment. [Figure 50] This is a schematic diagram showing a cap with one or more sensors that communicate with an electronic interface capable of providing feedback to a user, according to one exemplary embodiment. [Figure 51] This is a schematic diagram illustrating multiple states detected by a sensor system according to one exemplary embodiment. [Figure 52] This is a schematic diagram showing an alternative cap configuration according to one exemplary embodiment, in which the cap is configured to open when extended from the opening of the shaft member (for example, when a spring load is applied). [Figure 53] This is a schematic diagram illustrating a laparoscopic magnetic navigation device for controlling the movement of a magnetic device within the gastrointestinal tract or other lumen, according to several exemplary embodiments. [Figure 54A] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54B]This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54C] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54D] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54E] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54F] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54G] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54H] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54I] This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment. [Figure 54J]This figure shows an exemplary flexible, operable feeder having an angled cap for selectively feeding, capturing, and releasing a magnetic compression anastomosis device, according to one exemplary embodiment.

[0024] For a complete understanding of this disclosure, please refer to the following detailed description, including the appended claims, relating to the aforementioned drawings. While this disclosure is described in relation to exemplary embodiments, it is not intended to be limited to any particular form shown herein. It is obvious that various omissions and substitutions of equivalents are anticipated where indicated or advantageous by the circumstances.

[0025] Detailed explanation Exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses within the body, for example, in the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatment for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative care for diseases such as gastric cancer or colorectal cancer.

[0026] The system generally includes an access device placed within the patient's hollow body to form an anastomosis between a first portion and a second portion of hollow tissue at a target site, and configured to assist in forming the anastomosis at a target site (desired anatomical location) within the hollow body. The access device provides means for accessing the first and second portions of hollow tissue to form an anastomosis between the tissues at the target site, and is further configured to deliver and position first and second implantable magnetic anastomosis devices to the first and second portions of tissue or adjacent tissue. The first and second implantable magnetic anastomosis devices are configured to magnetically attract each other through a predetermined tissue region of the total thickness of the tissue wall at the target site, exerting a compressive force on the predetermined region to form the anastomosis.

[0027] The systems, apparatus, and methods described herein include, but are not limited to, various access devices for accessing a patient's hollow body, such as the gallbladder, and for positioning and then implanting one of a pair of magnetic anastomotic compression devices. The systems, apparatus, and methods described herein further include various feeding devices for advancing at least one of a pair of magnetic anastomotic compression devices to a target site, in which case, in some examples, the feeding device consistent with the disclosure may assist in deploying at least one of a pair of magnetic anastomotic compression devices, then fixing it to the target site, and / or coupling the pair of magnetic anastomotic compression devices together. The systems, apparatus, and methods described herein include various embodiments of magnetic anastomotic compression devices and various designs for transitioning from a compact feeding configuration to a larger deployment configuration, generally by a self-assembling design.

[0028] More specifically, exemplary embodiments provide a system including a delivery device for introducing and delivering a pair of magnetic assemblies between adjacent organs using minimally invasive techniques, thereby bridging the tissue walls of each organ and creating a passage (i.e., an anastomosis) between them. The delivery device is particularly useful in delivering a pair of magnetic assemblies to a target site in the gastrointestinal tract when obstruction occurs (due to disease or other health problems), thereby creating an anastomosis between the stomach wall and the gallbladder wall to facilitate proper drainage from the gallbladder.

[0029] An exemplary embodiment of the feeding device may include an anastomosis capture device having a cap for endoscopic or laparoscopic feeding devices. The cap can magnetically engage with a magnetic anastomosis device to control the magnetic anastomosis device and to couple with the other anastomosis device to form a pair for creating an anastomosis between tissues. The capture device is pivotable and rotatable relative to the endoscope to engage with, control, and release the anastomosis device.

[0030] Therefore, the exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses within the body, for example, in the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatment for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment for diseases such as cancer, including gastric cancer or colorectal cancer.

[0031] Figure 1 is a schematic diagram of an anastomosis system 10 for which improved placement of a magnetic anastomosis device at a desired site is achieved, thereby improving the accuracy of anastomosis formation between tissues within a patient 12. The system 10 generally includes an access device 14, a feed device 15,100, a magnetic anastomosis device 16,200, and an imaging modality 18.

[0032] The access device 14 may generally include, but is not limited to, an endoscope, laparoscope, catheter, trocar, or other feeding device. For most applications described herein, the access device 14 is an endoscope and includes a feeding needle configured to feed a magnetic anastomosis device 16,200. Thus, the system 10 of this disclosure relies on a single endoscope 14 to feed two magnetic devices 16,200. As described in more detail herein, the surgeon can advance the endoscope 14 into the hollow body of the patient 12 based on a visual depiction of the location of the target site provided by the imaging modality 18 and position the endoscope 14 at a desired anatomical location for forming an anastomosis. For example, the imaging modality 18 may include a display on which an image or other visual depiction of the target site is displayed to the surgeon when performing medical imaging processing, including but not limited to ultrasound (US), wavelength detection, X-ray-based imaging, illumination, computed tomography (CT), radiography and fluoroscopy, or a combination thereof. When the surgeon advances the endoscope 14 through the hollow body, they can rely on such visual representations to position the access device 14 in a portion of tissue adjacent to another portion of tissue at the target site, thereby ensuring that the magnetic device 16,200 is placed accurately.

[0033] It should be noted that the hollow bodies through which the access device 14 can pass include, but are not limited to, the stomach 40, gallbladder 42, pancreas, duodenum 41, small intestine, large intestine, intestinal tract, vascular system including veins and arteries, etc.

[0034] In some embodiments, a self-assembling magnetic device 16 is used to form a bypass within the gastrointestinal tract. Such a bypass may be used to treat cancerous obstruction, weight loss or obesity, or it may also be used to treat diabetes and metabolic diseases (i.e., metabolic surgery).

[0035] Figure 2 shows various gastrointestinal anastomosis targets that can be addressed by the apparatus of a particular exemplary embodiment, such targets including 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). Thus, the exemplary embodiment provides improved apparatus and techniques for minimally invasively forming anastomoses in the body, for example, within the gastrointestinal tract. Such apparatus and techniques facilitate faster and less expensive treatment for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative care for diseases such as gastric cancer or colorectal cancer.

[0036] For example, if the hollow body through which the access device 14 can pass is the patient's intestinal tract, the first portion may be the distal portion of the intestinal tract, and the second portion may be the proximal portion of the intestinal tract. The intestinal tract includes any segment of the digestive tract extending from the pyloric sphincter of the stomach to the anus. In some embodiments, the anastomosis is formed to bypass pathological, malformed, or dysfunctional tissue. In some embodiments, the anastomosis is formed to alter the “normal” digestive process in an effort to reduce or prevent other diseases such as diabetes, hypertension, autoimmune diseases, or musculoskeletal disorders. It should be noted that the system may be used to form an anastomosis (e.g., between the stomach and the gallbladder, between the duodenum and the gallbladder, from the stomach to the small intestine, from the small intestine to the large intestine, from the stomach to the large intestine, etc.) between a first portion of hollow body tissue at a target site and an adjacent second hollow body tissue.

[0037] In endoscopic procedures, a self-assembling magnetic device 16 can be advanced using a single endoscope 14. The deployment of the magnetic device 16 is schematically shown in Figure 3. As illustrated, an exemplary magnetic anastomosis device 16 is advanced through the endoscope 14, thereby causing the individual magnet segments to self-assemble and form a larger magnetic structure, an octagon in this particular case. When used with the techniques described herein, once the device is advanced as a completed assembly, the device 16 allows for the advancement of a magnetic structure larger than what would otherwise be possible, for example, within a standard endoscope, via a small advance conduit. A larger magnetic structure also allows for the formation of a larger and stronger anastomosis, achieving greater surgical success. For example, in some cases, the resulting anastomosis may have an aspect ratio of 1:1 with respect to the final dimensions of the assembled magnetic device. However, the exemplary embodiment allows for a larger aspect ratio (i.e., the formation of a larger anastomosis with respect to the dimensions of the magnetic assembly). In particular, systems and methods of the prior art that involve using magnets to form anastomoses are generally limited by the dimensions of the working channel of the scope or catheter used to deliver such magnets, which also limits the size of the resulting anastomose. However, the magnetic assembly designs of exemplary embodiments overcome such limitations. For example, the design of the magnetic assembly, in particular the coupling of multiple magnetic segments via an exoskeleton, allows any number of segments to be included in a single assembly, thereby resulting in an anastomose that is larger in size relative to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomose may have an aspect ratio in the range of 2:1 to 10:1 or greater. Such aspect ratios are described in more detail with respect to Figures 44A, 44B, 44C, and 44D.

[0038] Since the magnetic device 16 is radiopaque and echogenic, it can be positioned using fluorescence fluoroscopy, direct visualization (transillumination or tissue intrusion), and ultrasound, such as an endoscope ultrasound. The device 16 may be decorated with radiopaque paint or other markers to help identify the polarity of the device during implantation.

[0039] The magnetic anastomosis device 16 generally includes a plurality of magnetic segments 200 that can take on a feed configuration and an unfolded configuration. The feed configuration is typically linear, allowing the device to be delivered to tissue via a laparoscope's "keyhole opening" incision or via a natural pathway, such as the esophagus, using an endoscope 14 or similar device. Additionally, the feed configuration is typically somewhat flexible, allowing the device 16 to be guided through various curves in the body. Once the device 16 is delivered, it automatically converts from the feed configuration to an unfolded configuration, taking on the desired shape and size. This self-conversion from feed configuration to unfolded configuration is guided by a coupling structure 30 that moves the magnetic segments as desired without intervention. Exemplary self-assembling magnetic anastomosis devices 16, such as self-closing and self-opening types, are described in U.S. Patent No. 8,870,898, U.S. Patent No. 8,870,899, U.S. Patent No. 9,763,664 and U.S. Patent No. 1,0182,821, the contents of which are incorporated herein by reference in their entirety.

[0040] As shown in Figure 4A, magnetic anastomosis generally involves placing first and second magnetic structures 16a and 16b adjacent to first and second portions 20 and 24 of tissue 26 and 22, respectively, thereby joining the tissues 22 and 26. When the two devices 16a and 16b are brought close together, the magnetic structures 16a and 16b connect, joining the tissues 22 and 26. When the two devices 16a and 16b connect, the tissue trapped between the devices becomes necrotic, thereby forming an anastomosis. Alternatively, the tissues 22 and 26 joined by the devices 16a and 16b may be perforated after the devices are joined, thereby immediately forming an anastomosis. Over time, an anastomosis of the size and shape of the devices 16a and 16b is formed, and the devices detach from the tissues 22 and 26. In particular, the tissues 22 and 26 surrounded by the devices become necrotic and decompose, providing an opening between the tissues.

[0041] Alternatively, the joined devices 16a and 16b generate sufficient compressive force to stop blood flow to the tissues 22 and 26 trapped between the devices, so that the surgeon can form an anastomosis by making an incision in the tissues 22 and 26 surrounded by the devices, as shown in Figure 4B.

[0042] In yet another embodiment, as will be described in more detail herein and as shown in Figures 43A to 43I, the surgeon first makes an incision or punctures the tissue 22, 26, and then moves the magnetic devices 16a, 200a into the hollow body portion 20, thereby allowing the devices 16a, 200a to be positioned around the incision in the tissue 22. The surgeon then moves the devices 16b, 200b into the hollow body portion 24, thereby allowing the devices 16b, 200b to be moved around the incision in the tissue 26, and then connects the devices 16a, 200a and 16b, 200b to each other, thereby allowing the devices 16a, 16b (200a, 200b) to surround the incision. As before, once the devices 16a, 16b (200a, 200b) are connected, blood flow to the incision is immediately blocked.

[0043] While the figures and structures of this disclosure primarily relate to annular or polygonal structures, it is understood that the feeding and assembly techniques described herein can be used to form a variety of deployable magnetic structures. For example, self-assembling magnets can be reassembled into polygonal structures such as circles, ellipses, squares, hexagons, octagons, decagons, or other geometric structures forming closed rings. The device may optionally include additional handles, suture loops, jaws, and projections to achieve desired performance and to facilitate feeding (and removal). Still in another embodiment, a magnetic assembly such as the magnetic assembly 200 shown in Figure 42 may include a pair of magnetic segments 202, 204 arranged in a straight line with respect to each other (e.g., in an end-to-end configuration) and coupled to each other via a flexible exoskeleton member 206. Such embodiments will be described in more detail herein.

[0044] As described above, the self-assembling magnetic anastomosis devices 16 may be delivered to the target site via an access device 14. For example, as shown in Figure 5A, the access device 14 may include a feeder needle 28 (e.g., a puncture needle), which is used to deliver the first magnetic anastomosis device 16a into the lower small intestine (by puncture), and then the second magnetic device 16b is deployed into the upper small intestine at the location of tissue adjacent to the target site (as shown in Figure 5B). It should be noted that delivery may be guided by fluoroscopy or endoscopic ultrasound. Following self-assembly, these small intestinal magnetic devices 16a and 16b connect with each other (e.g., magnetically attract each other) over a predetermined tissue area of ​​the total thickness of the tissue wall at the target site, exerting a compressive force over the predetermined area to form an anastomosis.

[0045] Figure 6A shows an ultrasound-guided needle 14 being delivered into the gallbladder 42, where the magnetic assembly 16a then connects with a second magnetic assembly 16b in the stomach 40 or duodenum 41, as shown in Figure 6B. Thus, the procedure described may be used in conjunction with a procedure to remove or block bypassed tissue. For example, an ultrasound-guided (EUS) 14 may be used to facilitate transgastric or transduodenal access to the gallbladder 42 for the placement of a self-assembling magnetic anastomosis device 16. Once access to the gallbladder 42 is achieved, various strategies can be used to maintain an open portal between the stomach 40 and the gallbladder 42 or between the duodenum 41 and the gallbladder 42. In another embodiment, gallstones can be retrieved and fluidized using the endoscope. For example, an anastomosis can be formed between the gallbladder 42 and the stomach 40 using the method described. Once the gallbladder 42 is accessed transgastric or transduodenally, the gallstones can be removed. Furthermore, the gallbladder mucosa can be resected using any number of modalities, including but not limited to argon plasma coagulation (APC), photodynamic therapy (PDT), and sclerosing agents (e.g., ethanolamine or ethanol).

[0046] Figure 7 shows a single guide member 30 for deploying and manipulating the magnetic anastomosis device 16. For example, it is beneficial that the position of the device 16 can be manipulated once the self-assembling magnetic device 16 is delivered to the tissue. While the device 16 can be manipulated with conventional tools such as forceps, it is often easier to manipulate the position of the deployed device 16 using a guide member 30 such as a suture or wire. As shown in Figures 7 and 8A to 8F, various attachment points can be used to control the position and deployment of the self-assembling magnetic anastomosis device 16. For example, as shown in Figure 7, the guide member 30 can be attached to a single distal segment, thereby creating an attachment point that allows the single distal segment to have freedom of translational movement during self-assembly. The configuration shown in Figure 7 is also noteworthy in that it allows for a closing force to be applied to the most distal segment. That is, if one or more segments become entangled in the tissue or otherwise hinder self-assembly, the proximal tensile force from the guide member 30 can assist the device 16 in completing self-assembly. Once self-assembly is complete, the device 16 is positioned by the guide member 30 as described above, thereby enabling it to connect with another device (not shown) to form an anastomosis. Although not shown in Figure 7, it is assumed that additional structures such as a solid pusher or guide tube may be used to deploy the device 16 at the desired position.

[0047] The guide member 30 can be manufactured from a variety of materials to achieve desired mechanical properties and biocompatibility. The guide member 30 may be made of metal, such as wire, such as stainless steel wire or nickel alloy wire. The guide member may be made of natural fibers such as cotton or animal products. The guide member 30 may be made of polymers such as biodegradable polymers, such as polylactic acid (PLA), which contain repeating units of lactic acid, lactone, or glycolic acid. The guide member 30 may be made of high-tensile strength polymers such as Tyvek® (high-density polyethylene fiber) or Kevlar® (para-aramid fiber). In one embodiment, the guide member 30 is made of a biodegradable suture such as VICRYL® (polyglutinin 910) suture, available from Ethicon Corp., Somerville, NJ.

[0048] In some embodiments, the magnetic anastomosis device 16 may include a plurality of guide members 30. For example, as shown in Figures 8A, 8B, 8C, 8D, 8E, and 8F, various mounting points may be used to control the position and deployment of the self-assembling magnetic anastomosis device 16. As shown, four guide members 30(1) to 30(4) may be coupled to four separate segments of the device 16, respectively. Each guide member may include a distal end coupled to each part of the anastomosis device and a proximal end, and by manipulating the proximal end (i.e., increasing or decreasing tension), the anastomosis device 16 can be manipulated to self-assemble into a predetermined shape (i.e., a polygon) and then its position and orientation can be controlled. For example, as shown, guide member 30(1) is coupled to the most distal end segment, guide members 30(2) and 30(3) are coupled to the intermediate segment (the segment between the most distal end segment and the nearest end segment), and guide member 30(4) is coupled to the nearest end segment.

[0049] Figures 9 to 12 illustrate various methods for accessing the target site, specifically, various methods for accessing the gallbladder 42 by procedures guided by an endoscopic ultrasound 14. Figure 9 shows the use of monopolar energy in a high-temperature probe or guidewire 43 for puncture access to the gallbladder 42.

[0050] Figure 10 shows the use of a fine-needle aspiration (FNA) 28 to puncture and access the gallbladder 42.

[0051] Figure 11 shows the use of a spiral needle 44 to puncture and access the gallbladder 42.

[0052] Figure 12 shows the use of a guidewire 46 to puncture through the bile duct 45 toward the gallbladder 42.

[0053] Figure 13 shows a needle 28 guided by an ultrasound endoscope 14, which punctures the gallbladder 42 to access the inside of the gallbladder 42 and then delivers a magnet assembly 16 into the gallbladder 42.

[0054] Figures 14, 16, and 17 show various devices for securing access and / or delivery devices to a target site in the gallbladder 42. Figure 14 shows a T-bar member 47 connected to a tether 48. Figure 15 shows a Nitinol coil (e.g., a "pigtail") 49. Figure 16 shows a balloon member 50 of the catheter. Figure 17 shows a Malecot catheter 51.

[0055] Figures 18A to 18F illustrate a method of accessing the gallbladder via an ultrasound-guided access means 14 and using an access device 43 that emits monopolar energy, fixing a delivery device using a balloon catheter 50, and then advancing a pair of magnetic anastomose devices 16a, 16b from the delivery device sheath 52 within the balloon 50, while fixing the balloon 50 within a jejunal incision formed between the tissue of the gallbladder 42 and adjacent tissue (i.e., the tissue of the stomach 40 or duodenum 41), thereby deploying the devices 16a, 16b on both sides of each tissue 22, 26 (i.e., the first device in the gallbladder and the second device in the stomach or duodenum) to form an anastomosis between them. The magnetic assemblies 16a, 16b are housed within the balloon 50 inside the delivery device sheath 52. As shown in Figure 18C, when the conductor 53 is advanced by pulling back the sheath 52, the balloon 50 and magnetic assembly 16a are deployed into the gallbladder 42. The expansion line 54 inflates the balloon 50 so that the magnetic devices 16a and 16b can self-assemble. The balloon 50 has an internal channel 55 as shown in the cross-sectional view in Figure 18E. The monopolar energy tip 43 is then removed from the formed intestinal incision as shown in Figure 18F.

[0056] Figure 19 shows one modification of the design shown in Figures 18A to 18F, specifically, using a balloon 50 to deliver a single magnetic anastomosis device 16a into the gallbladder 42 rather than a pair.

[0057] Figures 20A to 20C show a method of accessing the gallbladder 42 via an ultrasound-guided access means 14 using a high-temperature insertion tube 43 that emits monopolar energy, and then delivering a magnetic anastomosis device 16 into the gallbladder 42 via the high-temperature tube 43. The EUS scope 14 is advanced through the stomach 40. The monopolar energy tip or the high-temperature insertion tube 43, using a monopolar ring 56 provided at the end of the tube 43, punctures the stomach and gallbladder tissues 26,22 toward the gallbladder 42, and then deploys the magnetic anastomosis device 16 into the gallbladder 42 (Figure 20C).

[0058] As shown in Figure 20B, in order to advance the insertion tube 43 into the gallbladder 42, the user only needs to activate the monopolar energy.

[0059] Figures 21A to 21E show how to access the gallbladder 42 via an access means guided by an ultrasound endoscope 14 and using an access device having a conductor including a "high-temperature" tip 43 that emits monopolar energy, and how to fix the delivery device using a Malecot catheter 51, and then fix the Malecot catheter 51 in a jejunal incision formed between the gallbladder tissue 26 and adjacent tissue 22 (i.e., stomach or duodenal tissue), while using a magnetic anastomosis device 16 via a push rod 57 to deliver the Malecot catheter 51 into the gallbladder 42. The "high-temperature" tip 43 punctures the stomach and gallbladder tissues 22,26 to advance the delivery device 14 into the gallbladder 42. The conductor 53 advances the high-temperature tip 43 into the gallbladder 42, while the push rod 57 advances the magnetic array 16. As shown in Figure 21C, the Malecot catheter 51 fixes the device in the gallbladder 42. To deploy the magnetic array into the proximal lumen of the stomach 40, the surgeon simply needs to withdraw the push rod 57. The high-temperature tip is then advanced into the gallbladder 42 (Figure 21D). Figure 21E shows the magnetic assembly 16 deployed through a slot in the Malecot catheter 51 as shown in the upper figure, or the magnetic assembly 16 deployed through an end 59 as shown in the lower figure. The push rod 57 is advanced to deploy the magnets 16. In some embodiments, the window of the Malecot catheter 51 may have a radiopaque marker 58 to maintain the orientation of the window properly.

[0060] Figures 22A to 22C illustrate a variation of the procedure and apparatus shown in Figures 21A to 21E, in which the magnetic anastomosis device 16 is pre-loaded into the distal end of the Malecot catheter 51 of the feeding device 14, so that when the Malecot end 59 moves to a fixed position, the device 16 is fed and deployed. A suture 60 may be used to guide the magnetic anastomosis device 16 from the Malecot catheter body 51 into the distal lumen 97. The magnet 16 is directed by being pushed out from the distal end of the Malecot catheter 51 and pulling back the suture 60. By pushing the Malecot catheter 51 forward, the catheter window 61 cuts the suture 60 and releases the magnetic assembly 16.

[0061] Figure 23 shows a Malecot catheter 51 having a distal end that expands into a fixed position on one side of the tissue wall 26 of the gallbladder 42. Figure 24 shows a Malecot catheter 51 having distal ends that expand into fixed positions on both sides of the tissue wall 26 of the gallbladder. In either example, a temporary Malecot can be placed inside the gallbladder 42 to form a temporary conduit, thereby enabling immediate drainage and also allowing ventilation of the gallbladder. Note that any embodiment providing means of access from the gastrointestinal tract to the gallbladder (Marecot, high-temperature tube, Nitinol coil, balloon, etc.), specifically any device that forms a channel through which the magnetic anastomosis device 16 passes, can function as a drainage channel. More specifically, after the access channel is formed and before the delivery of the magnetic anastomosis device 16 begins, any fluid or material in the gallbladder can be drained (either by itself or when aspiration is applied). The channels can also be used to push fluid into the gallbladder before it is emptied (potentially performing multiple filling / emptying cycles), which can "cleanse" the gallbladder if it has excess fluid and contents (i.e., bile or other contents) inside.

[0062] Figures 25A to 25E illustrate how to access the gallbladder 42 via an ultrasound-guided access needle (22 or 25 gauge for easy access), fix the feeding device using a T-bar assembly 47 and a stabilizer member 62, and then feed the magnetic anastomosis device 16 into the gallbladder 42 via a deployment sheath 52 through the stabilizer member 62, while fixing the T-bar 47 within the enterotomy formed between the gallbladder tissue 26 and adjacent tissue 22 (i.e., stomach or duodenal tissue). As shown in Figure 25A, the T-bar 47 is anchored to the wall of the gallbladder 42 by a tether 48. Then, as shown in Figure 25B, the stabilizer member 62 is advanced to the wall of the duodenum 41 or stomach 40 for traction. Then, as shown in Figure 25C, the deployment sheath 52 is advanced into the gallbladder 42, where the magnetic anastomosis device 16 can be fed. Figure 25D shows a T-bar 47 that secures the feeding device 14 within the wall of the gallbladder 42 by retracting the tether 48. The surgeon advances the deployment sheath 52 and deploys the magnetic device 16a within the gallbladder 42. In some embodiments, the feeding device 14 may rotate to assist in aligning the magnetic device 16 within the gallbladder 42. Figure 25E shows a fully formed magnetic device 16 surrounding or encircling the T-bar 47. In some embodiments, the T-bar 47 may be magnetic to engage with the anastomosis device 16.

[0063] Figures 26A to 26C show one variation of the procedure and apparatus shown in Figures 25A to 25E, in which the deployment sheath 52 has a notch 63 at its distal end, the notch 63 is configured to engage with the T-bar 47 as it advances through the intestinal incision, thereby pressing the T-bar 47 laterally and then enabling the feeding and deployment of the magnetic anastomosis device 16.

[0064] Figures 27A to 27C show another variation of the procedure and apparatus shown in Figures 25A to 25E, in which case the assembly shown in Figures 27A to 27C relies on depositing T-bars 47 through an access needle 28, rather than having a deployment sheath for advancing the self-assembling magnetic anastomosis device 16 as described herein. This arrangement causes a group of T-bars 47 to self-assemble to form an array and, as a distal anastomosis device, to connect with a proximal magnetic anastomosis device 16b located on the opposite side, and then work to compress the tissue between them to form an anastomosis. Each T-bar 47 is magnetic and is anchored to the advancing device by a suture 60. Figure 27C shows a plurality of magnetic T-bars 47 stored linearly within the access needle 28 for deployment into the lumen and anchored to the advancing device 14 by a suture 60.

[0065] Figures 28A to 28C illustrate how to access the gallbladder 42 via an ultrasound-guided access needle access means 14 using a side port deployment sheath 63 for advancing and deploying a pair of magnetic anastomosis devices 16.

[0066] Figure 28A shows an EUS scope 14 accessing the stomach 40 and puncturing the stomach tissue toward the gallbladder 42. By advancing the deployment sheath 52 into the gallbladder 42, the distal magnet 16b is deployed into the gallbladder 42. The surgeon withdraws the feeder 14, thereby bringing the side port 63 in the feeder completely into the stomach 40. The second anastomosis device 16b is then deployed from the side port 106 in the sheath 52.

[0067] Figure 28B shows one embodiment of the device, which is provided with a metal ring 64 that guides the magnet 16 on the outside and around the feeder 14. The magnet 16 is deployed from a side port 63 of the sheath 52. The magnet 16 is captured by a metal insert 65 of the rotating ring 64. To assist in the deployment and assembly of the magnet 16, the ring 64 rotates around the feeder 14. In some embodiments, the ring 64 may rotate freely or rotate when the magnet 16 is pushed out. In some embodiments, the ring 64 may be actively rotated to pull out the magnet 16.

[0068] Figure 28C shows an enlarged view of the metal ring 64. The metal ring 64 completely encloses the sheath 52 of the feeder 14 and guides the magnet 16 around the feeder 14 to assist in deployment and assembly.

[0069] Figures 29A to 29C show a knotting member 66 configured to fix the already deployed and positioned magnetic anastomosis device 16 to the tissue at the target site, and then cut the guide member or suture 60 to which it is attached. As shown in Figure 29A, the knotting member 66 is advanced within the working channel of the scope 14, placed over the guide member or suture 60. The knotting member 66 is advanced by the scope 14 through the stomach 40, thereby cutting the suture 60 of the anastomosis device 16 that has been pre-positioned inside the stomach 40 and gallbladder 42.

[0070] As shown in Figure 29B, the knotting member 66 moves toward the magnetic anastomosis device 16, in which case the knotting member 66 generally consists of an outer tube member 67 and an inner rod member 68, so that when it reaches the device, the inner rod member 68 is pressed toward the distal end of the outer tube member 67, thereby fixing a part of the guide member 60 between the outer tube member 67 and the inner rod member 68, and further allowing the guide member 60 to be cut in this process.

[0071] Figure 29C shows an inner rod member 68 tightened against the outer tube member 67 of the knot member 66 to cut the suture or guide member 60 from the magnetic anastomosis device 16.

[0072] Figures 30A to 30D show a method for accessing the gallbladder 42 by an ultrasound-guided access needle access means 14 and advancing a magnetic coil 69 or ring, which is configured to transition substantially linear to substantially annular when advanced into the gallbladder 42, and the distal anastomosis device is configured to connect with a proximal magnetic anastomosis device 16b located on the opposite side, and then work to compress the tissue between them to form an anastomosis.

[0073] Figure 30A shows an EUS scope entering the stomach 40. The access needle 28 punctures the tissue of the stomach 40 and gallbladder 42, thereby deploying a metal coil 69 into the gallbladder 42. The metal coil 69 is linearly stored in a feeder 14 as shown in Figure 30B, and when deployed, forms a substantially annular shape. In some embodiments, the metal coil 69 is manufactured from a laser-cut hypotube to allow the metal coil 69 to be bent.

[0074] Figure 30C shows the hypotube 69 as it is deployed from the feeding device 14 into the gallbladder 42, advancing along the nitinol coil 49. As the metal hypotube 69 is advanced along the nitinol coil 49, as it is deployed, the metal hypotube 69 changes its shape from substantially linear when it exits the storage area to substantially annular.

[0075] Figure 30D shows a proximal magnet 16b that engages with a metal hypotube 69, thereby compressing the tissue between them to form an anastomosis.

[0076] Figures 31A and 31B show a set of magnetic segments 202, including a plurality of guide members 30, tethers 48, or sutures 60, which are pre-packaged with unstable polarity and connect adjacent segments 202 to each other to facilitate self-assembly of the magnetic segments into a polygonal unfolded shape. The magnetic segments 202 are pre-packaged with unstable polarity, so that they self-assemble to form the desired shape when unfolded. End-to-end tethers 48 assist the magnetic segments 202 in snapping motion to form the desired shape.

[0077] Figures 32A and 32B illustrate a method of accessing the gallbladder 42 by an ultrasound-guided access means 14 using an access device having a conductor including a "high temperature" tip 43 that emits monopolar energy, and then delivering the pre-packaged magnetic segment 202 shown in Figures 31A to 31B into the gallbladder 42 via a sheath 52.

[0078] Figure 32A shows the EUS scope 14 accessing the stomach 40. A “high-temperature” tip 43 that emits monopolar energy is used to puncture the tissue of the stomach 40 and gallbladder 42 and access the gallbladder 42. Once the gallbladder 42 is accessed, the magnetic assembly 16 is deployed, as shown in Figure 32B.

[0079] Figure 32B shows the deployment of the magnetic anastomosis device 16a into the gallbladder 42. The "high-temperature" tip 43 punctures the tissue of the stomach 40 and gallbladder 42, thereby providing access to the gallbladder 42. A sheath 52, containing the distal magnetic assembly 16a, spacer 70, and proximal magnetic assembly 16b in a linear arrangement, is advanced into the gallbladder 42. By withdrawing the sheath 52, the distal magnetic assembly 16a is deployed into the gallbladder 42, where it self-assembles to form a polygon, an octagon in this figure.

[0080] Figures 33A to 33C show a method for accessing the gallbladder 42 by an ultrasound-guided access means 14 using a needle 28 to access the gallbladder 42, and then feeding a rolled stack of magnetic segments 202 configured such that a distal anastomosis device 16a connects with a proximal magnetic anastomosis device 16b located on the opposite side, and then works to compress the tissue between them to form an anastomosis.

[0081] As shown in Figure 33A, the Nitinol coil 49 is advanced into the gallbladder 42 via the access needle 28 in the EUS scope 14. The magnetic segment 202 is then advanced around the expanded Nitinol coil 49, which is held in place by the suture 60 as shown in Figure 33B. When the suture 60 is pulled, the magnetic segment 202 folds over (based on magnetic attraction) as shown in Figure 33C, and when the Nitinol coil 49 is removed, a wound stack of magnets 16 is formed.

[0082] Figures 34A to 34B show a method of accessing the gallbladder 42 by an ultrasound-guided access means 14 using a needle 28 to access the gallbladder 42, and then delivering into the gallbladder 42 a suspension of magnetic fluid or magnetic particles 71 configured to act as a distal anastomosis device, coupled to a proximal magnetic anastomosis device 16b located on the opposite side, and then working to compress the tissues 22,26 between them to form an anastomosis.

[0083] Figure 34A shows an EUS scope 14 accessing the stomach 40. An access needle 28 punctures the tissue of the stomach 40 and gallbladder 42, thereby accessing the gallbladder 42. The access needle 28 then deploys magnetic fluid or magnetic particles 71 into the gallbladder 42.

[0084] Figure 34B shows magnetic particles 71 attracted to the deployed proximal magnetic anastomosis device 16b. The magnetic particles 71 form a polygonal annular shape that matches the shape of the proximal anastomosis device 16b, thereby compressing the tissues 26,22 between the devices to form the anastomosis site.

[0085] Figure 35 shows a magnetic anastomosis device 16 that includes a continuous guide member or suture 60 coupled to the multiple magnetic segments 202 of the device via eyelets 72 positioned on each of the multiple magnetic segments 202. The eyelets 72 are positioned inside the magnets 16 to prevent the suture 60 from becoming trapped or pinched between the magnets 16. The continuous suture 60 extends through the eyelets 72 to guide and position the magnets 16 to form the anastomosis. The legs 73a, 73b, and 73c of the suture may be pulled individually or simultaneously to manipulate the magnets 16. To remove the suture 60, the legs 73a or 73c may be pulled individually.

[0086] Figure 36 shows one embodiment of a suture cutting device in the deployment sheath 52 of a feed device or a secondary device for cutting a suture 60 coupled to a magnetic anastomosis device. A push / pull guillotine utilizing an anvil / sharp or sharp / sharp configuration is used to cut the suture 60. By pushing and pulling the cutting device, the blade is exposed. By pressing / pulling the cutting device, tension is also introduced into the suture. The tensioned suture is pulled past the sharp cutting edge of the cutting device and cut, and then removed from the cutting device. In some embodiments, the cutting device may be twisted to expose the blade that cuts the suture.

[0087] Figures 37A and 37B are enlarged side views showing an anvil / sharpening device and a sharp / sharpening device for cutting sutures. Figure 38 shows a snare device (secondary device) configured to be inserted over a guide member or suture coupled to a magnetic anastomosis device, and configured to cut the suture or guide member when the magnetic anastomosis device is deployed and positioned at the target site.

[0088] Figure 37A shows the Sharp 74 / Anvil 75 cutting device. The tensioned suture 60 is brought over the exposed sharp blade 74 and cut by pushing and pulling the cutting device.

[0089] Figure 37B shows a sharp / sharp cutting device. By pushing and pulling the cutting device, two sharp blades 74 are exposed to cut the tensioned suture 60.

[0090] Figure 38 shows a snare device 76 for cutting the suture 60. The snare device 76 enters the stomach 40 via an endoscope or similar feeding device 14. After the magnet 16 is positioned in the desired location to form the anastomosis, the snare device 76 is placed over the suture 60 and advanced through the working channel of the scope 14. The snare device 76 cuts the suture 60 and removes the suture 60 from the deployed magnetic anastomosis device 16.

[0091] Figure 39A shows a snare device 76 including a resistance heating member 77 for cutting the guide member 60. The snare member 76 has a support tube 78 that guides the snare device 76 to the position where the suture 60 is to be cut. The resistance heating member 77 can be powered by a low voltage from a battery or generator. By pulling the snare device 76, the resistance heating member 77 applies energy to the suture 60 to cut it, releasing the suture 60 from the magnetic anastomosis device and then removing it.

[0092] Figure 39B shows an enlarged view of the snare device 76. The snare device 76 may be located outside the scope 14 or may be incorporated into the cap of the scope 14. The snare device 76 is housed within the snare sleeve 79. A deployment means or feed needle 28 deploys the magnet 16 into the stomach 40. The snare device 76 is advanced within the snare sleeve 79 as shown in Figure 39C.

[0093] Figure 39C shows a snare device 76 including a ring member 80 having a cutting edge for cutting the guide member 60. The snare device 76 captures the suture 60 within the loop. By pulling back the snare sleeve 79, the ring member 80 cuts the suture 60, detaching the suture 60 from the magnet 16 and then removing it.

[0094] Figure 39D shows a secondary device configured to use monopolar / bipolar energy to cut the suture 60 or guide member 30. Once the magnet 16 is positioned in place on the tissue 22,26, the monopolar / bipolar "high-temperature" tip 43 is used to cut the suture 60. The monopolar or bipolar tip 43 is activated when the feeder 14 is retracted.

[0095] Figure 40 shows a detachable guide member or suture 60. The suture 60 has a diameter-reduced or weakened portion 81. When the suture 60 is pulled back, the suture 60 is separated at the weakened portion 81 and removed from the magnetic assembly 16, and then the suture 60 is removed.

[0096] Figures 41A and 41B show an assembly of a removable suture 60. Within the sheath 52 of the feeder 14, the sutures, including the overmolded drivers 82, are stored in an alternating arrangement as shown in Figure 41A. In some embodiments, multiple sutures 60, each including an overmolded driver 82, may be stored in separate lumens. The overmolded drivers 82 are stored in a constrained position within the sheath 52. When unfolded by removing the sheath 52, the overmolded drivers are no longer constrained and are separated from each other, as shown in Figure 41B. Once the overmolded drivers 82 are separated, the suture 60 can be removed from the patient.

[0097] Therefore, the exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses within the body, for example, in the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatment for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative care for diseases such as cancer, including gastric or colorectal cancer. More specifically, the exemplary embodiments provide various systems, devices and methods for feeding, deploying, and positioning a magnetic compression device at a desired site, thereby improving the accuracy of anastomosis formation between tissues, organs, etc.

[0098] Figure 42 shows a perspective view of another embodiment of the magnetic assembly 200 consistent with the present disclosure. The magnetic assembly 200 generally includes a pair of magnetic segments 202, 204 arranged in a straight line with respect to each other (for example, in an end-to-end configuration) and coupled to each other via a flexible exoskeleton member 206. The segments 202, 204 are separated by a central portion 208 of the exoskeleton 206. The central portion 208 may include a connecting member for receiving a corresponding connecting member of a retaining device that assists in feeding the magnetic assembly 200, as will be described in more detail herein. The exoskeleton may be made from an elastic material that retains its shape after deformation, such as a polymer or a metallic alloy. In some embodiments, the metallic alloy will include nickel, such as nitinol. Exemplary embodiments of the exoskeleton are described in U.S. Patent No. 8,870,898, U.S. Patent No. 8,870,899, and U.S. Patent No. 9,763,664, the contents of which are incorporated herein by reference in their entirety.

[0099] The magnetic assembly 200 is configured to be delivered and deployed to a target site via a delivery device 100. As described above, the exemplary embodiment provides an improved device and technique for minimally invasively forming anastomoses in the body, for example, in the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatment for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment for diseases such as cancer, such as gastric cancer or colorectal cancer. More specifically, the exemplary embodiment provides a system including a delivery device 100 for introducing and delivering a pair of magnetic assemblies 16a, 16b between adjacent organs using minimally invasive technique, bridging the walls of the tissues 22, 26 of each organ, thereby forming a passage (i.e., an anastomosis) between them. The delivery device 100 is particularly useful in delivering a pair of magnetic assemblies 16 to a target site in the gastrointestinal tract when an obstruction occurs (due to disease or other health problems), thereby forming an anastomosis between the stomach wall and the gallbladder wall, resulting in proper drainage from the gallbladder.

[0100] Figures 43A to 43I illustrate the various steps involved in deploying a pair of magnetic assemblies 200a, 200b to a target site and subsequently forming an anastomosis. In the embodiments described herein, the system generally includes a single scope, such as an endoscope 14, laparoscope, catheter, trocar, or other access device, through which a feeding device is advanced to a target site to feed and position the pair of magnetic assemblies 200a, 200b, and subsequently form an anastomosis at the target site. In particular, the feeding device 100 includes an elongated hollow body 102, such as a catheter, shaped and / or sized to fit within the scope. The feeding device includes a working channel into which the pair of magnetic assemblies 200a, 200b are loaded. The feeding device further includes a distal end 104 configured to puncture or otherwise penetrate tissue.

[0101] For example, Figure 43A shows the distal tip of the feeder 100 advancing through the tissue walls of adjacent organs at the target site, and then forming an anastomosis between them. For example, the distal end 104 may have a sharp tip for puncturing tissue and / or may utilize the energy (i.e., a high-temperature tip) entering through the tissue. The body 102 of the feeder 100 further includes a slot or opening 106 adjacent to the distal end 104, as shown in Figure 43B. As shown, the slot extends overall through the side of the body 102 of the feeder 100. The slot 106 is shaped and / or dimensioned to receive magnetic assemblies 200a, 200b through the slot 106, so that the magnetic assemblies 200a, 200b pass through the working channel and exit the feeder 100 through the slot 106. The feeder 100 further includes a retaining member 108 which is generally in the form of a wire or the like, and is detachably coupled to one or both of the magnetic assemblies 200a, 200b, and provides a means for deploying the magnetic assemblies 200a, 200b from the distal end of the feeder 100 via a slot 106.

[0102] During the procedure, a surgeon or other skilled medical professional can advance the scope 14 (e.g., endoscope) into the patient's hollow body and position the scope 14 at a desired anatomical location, thereby forming an anastomosis based on a visual depiction of the location of the target site provided by an imaging modality 18 that provides medical imaging (e.g., ultrasound (US), wavelength detection, X-ray-based imaging, illumination, computed tomography (CT), radiography and fluoroscopy, or a combination thereof). The surgeon can advance the distal tip 104 of the feeding device 100 through the adjacent walls of a pair of organs (i.e., through the wall of the duodenum 41 and the wall of the common bile duct 45) in any of the manner described herein. When advancing the distal end 104 including the slot 106 into the first organ 45 (i.e., the common bile duct), the surgeon can use the placement member 108 to manually feed and deploy the first magnetic assembly 200a into the first organ 45 through the slot. For example, Figure 43C shows the first magnetic assembly 200a being fed into the common bile duct 45. As shown, the implantation member 108 includes a connecting member 110 at the attachment point 113 at the distal end of the implantation member 108, and the connecting member 110 is configured to be removably coupled to a corresponding connecting member of the central portion 208 of the exoskeleton 206 (indicated by the arrow at the attachment point). As the implantation member 108 is advanced and expanded toward the distal end 104 of the feeding device 100, the first magnetic assembly transitions to an unfolded state by passing through the slot 106 from the working channel of the feeding device 100, as shown in Figure 43D. As shown, as a result of the unfolding of the first magnetic assembly 200a, a pair of magnetic segments 202, 204 exit the slot 106 on opposite sides of the body 102 of the feeding device 100, while the central portion 208 of the exoskeleton 206 remains in the slot 106. In other words, the slot 106 extends through the body 102 of the feeder 100 from one side to the other. Therefore, when deployed, the first magnetic assembly 200a is positioned within the first organ while remaining held within the slot 106 of the feeder 100.

[0103] At this point, the surgeon only needs to retract the feeder 100 until the first magnetic assembly 200a engages with the tissue of the first organ and most of the slot 106 is positioned within the second organ 41. The surgeon can then feed and deploy the second magnetic assembly 200b into the second organ (i.e., the duodenum 41). Figure 43E shows the first magnetic assembly 200a fully deployed within the first organ and the first magnetic assembly 200a being drawn to the wall of the common bile duct by retracting the feeder 100 in preparation for the feeding and deployment of the second magnetic assembly 200b into the duodenum.

[0104] The second magnetic assembly 200b unfolds in the same manner as the first magnetic assembly 200a; that is, the magnetic segments 202 and 204 of the second magnetic assembly 200b also exit the slot 106 on opposite sides of the main body 102 of the feeder 100, while the central portion 208 of the exoskeleton 206 remains held within the slot 106. Figure 43F shows the second magnetic assembly 200b being fed into the duodenum. Figure 43G is a magnified view showing a partial cross-section of the second magnetic assembly 200b as it moves into the unfolded state. As shown, the second magnetic assembly 200b is advanced through the work channel toward the slot 106, so the assembly 200b is configured to engage with the inclined portion 112 of the implantation member, as shown, which helps guide at least one of the segments of the assembly 200b into place. Figure 43H shows the first magnetic assembly 200a and the second magnetic assembly 200b in their fully unfolded state. The first magnetic assembly 200a and the second magnetic assembly 200b are substantially aligned with each other, and based on magnetic attraction, the first magnetic assembly 200a and the second magnetic assembly 200b will be coupled to each other.

[0105] As shown in Figure 43I, the distal end 104 of the feeder 100 consists of two halves that form a relatively uniform tip shape when in the default state. However, the distal end contains a deformable material (i.e., shape memory material), so that when sufficient force is applied, the two halves will separate. Thus, once both the first and second magnetic assemblies 200a, 200b are fed and effectively coupled to each other (but still held within the slot 106), the surgeon only needs to pull back the feeder 100, which then brings the magnetic assemblies 200a, 200b into contact with the distal end 104, forcing the two halves of the distal end 104 to separate, allowing the distal end of the feeder to be withdrawn from the target site while the pair of magnetic assemblies 200a, 200b remain in place. A pair of magnetic assemblies 200a, 200b compress the walls 22, 26 of each organ between them, and then form an anastomosis between the organs (i.e., the anastomosis between the duodenum and the common bile duct).

[0106] When deployed, each magnetic assembly has a width and length roughly corresponding to the width of each segment and approximately twice the length of each segment. As a result, when a pair of magnetic assemblies are joined together, they generally form a substantially linear package, and the shape of the resulting anastomosis may generally be rectangular, but may of course be circular or elliptical. The resulting anastomosis may have an aspect ratio of 1:1 with respect to the dimensions of the magnetic assembly. However, exemplary embodiments allow for a larger aspect ratio (i.e., the formation of a larger anastomosis with respect to the dimensions of the magnetic assembly). In particular, systems and methods of the prior art that involve using magnets to form anastomosis are generally limited by the dimensions of the working channel of the scope or catheter used to deliver such magnets, which also limits the size of the resulting anastomosis. The design of magnetic assemblies overcomes such limitations.

[0107] For example, the design of the magnetic assembly, particularly the coupling of multiple magnetic segments 202 via an exoskeleton 206, allows for any number of segments 202 to be included in a single assembly 16, thereby resulting in the resulting anastomosis having a larger size relative to the dimensions of the working channel of the scope 14. For example, in some embodiments, the resulting anastomosis may have an aspect ratio in the range of 2:1 to 10:1 or greater.

[0108] Figures 44A–44D are cross-sectional views showing various cross-sections of magnet segments in a magnetic assembly within a standard scope's working channel. The illustrated magnet cross-sections show that polygonal, elliptical, and circular shapes occupy 10–95 percent of the annular space of the working channel. With guidelines provided for the magnetic cross-sections, the following constraints on the device are that the axial ratio is between 50:1 and a minimum of 6:1. When assembled in the body, these segmented lengths can have either a regular or irregular shape.

[0109] Figure 45 provides a list of several exemplary working channel sizes that are considered usable / workable for deploying a caged magnetic array to form an anastomosis. Scope channel sizes will increase or decrease with market and instrument changes, so these sizes do not limit future possibilities. The sizing overview can be summarized as 1.0 mm to 6.0 mm (including bleedscopes called “thrombusters”), using one specific size instrument designed to approximately 3.7 mm.

[0110] Therefore, the delivery device of this disclosure forms an inconspicuous linear anastomosis that enables the reduction of certain complications, particularly those involving obstruction of the common bile duct. In particular, patients suffering from obstruction of the common bile duct often undergo some procedure to remove the obstruction or to enable drainage that results in the reduction of jaundice / infection and hilar complications. Common procedures are sphincterotomy or the placement of some drainage stent. There are procedures that provide decompression of the bile duct in the conventional way, but this is not possible in a minimally non-invasive manner. Such procedures include, for example, sphincterotomy, but sphincterotomy is not possible on the basis that a cannula cannot be inserted into the common bile duct, and that anatomical changes cannot be taken into account, especially in the midst of a severe illness. The use of a cross section with magnetic closure force as described herein will enable minimal bleeding and will form a semi-permanent slit cross section. This slit cross section will help resist "sump syndrome" and will help form a drainage point that will effectively remain infection-free.

[0111] Some exemplary embodiments include a capture device (hereinafter referred to as "cap") for the distal end of an endoscope or other feeding device 14 (e.g., laparoscope, catheter, etc.), which is configured to magnetically manipulate a specific type of target device within the patient's hollow body (lumen). While exemplary cap embodiments are described herein for use with the compression anastomosis devices of the types described herein (e.g., self-assembling magnetic compression anastomosis devices 16), it should be noted that caps may additionally or alternatively be configured or used to capture other types of devices, such as, but not limited to, annular devices, disc-shaped or spherical devices, linear or curved devices, solid devices, hollow devices, signaling devices, multiple devices, etc. Therefore, references to caps for use with compression anastomosis devices should be understood to include caps for use with any of the aforementioned target devices.

[0112] Generally, the target device is magnetic (and may also be simply referred to herein as “magnet”), in which case the cap may include a magnetic or magnetizable (e.g., metallic or electromagnetic) member 85 that is attached to or integrally formed with the cap and capable of magnetically capturing the target device. Alternatively, the target device may be nonmagnetic but capable of being captured by a magnet, in which case the cap may include a magnetic or electromagnetic member 85 that is capable of magnetically capturing the target device.

[0113] In some exemplary embodiments, the cap includes a pivot / foldable capture member, which allows the cap and any device to be captured, to be oriented at a predetermined angle, to be more easily inserted and / or translated, for example, through a lumen or body cavity, and allows the user to operate the compression anastomosis device 16 to align and change the angle orientation for transluminal connection. However, it should be noted that many of the capture and release modes described herein may be used with a non-pivot cap. The cap may contain a substantially transparent material to allow transparency of the cap. The cap may be configured to utilize magnetic field detection to capture, control, connect, and release the compression anastomosis device 16. In preferred embodiments, the detection and holding forces of the device are optimized to release the compression anastomosis device 16 only when properly connected, and to allow improperly connected devices to be separated, realigned, and properly connected.

[0114] Figure 46 is a schematic diagram showing an exemplary cap according to one exemplary embodiment, which has the ability to capture a compression anastomosis device and orient it to a predetermined angle, allowing for easier translation within the lumen. Here, the cap is shown as a separate component that can be attached to the distal end of an endoscope or other feeding device 14 (e.g., engaging with a shaft or tubular member such as an endoscope, and preferably including an outer skirt having a surrounding elastic material or other mounting mechanism for improving clamping to the feeding device), however, the cap may optionally be integral with the distal end of the endoscope or other feeding device.

[0115] In this exemplary embodiment, the cap comprises a cap body 83 having an angled distal end and a pivot cap member 84 (referred to herein as “plate”), the pivot cap member 84 being coupled to the distal end of the cap body 83 and being movable at least between a first position or closed position where the cap plate 84 is substantially angled with respect to the distal end geometry (as shown, for example, in Figure 46) and a second position or open position where the cap plate 84 is pivoted away from the cap body 83 (as shown, for example, in Figures 47 and 48). The cap plate 84 may be coupled to the cap body 83 using a suitable pivot mechanism 86 (e.g., one or more pins 87 highlighted in Figure 47, or a hinge, ball joint, etc.). The device may include a biasing mechanism 90 (e.g., one or more springs 90 as shown in Figure 47) that biases the cap plate toward the closed position. In the examples shown in Figures 46 to 48, the cap plate 84 is configured to move between a closed position of approximately 45 degrees and an open position of approximately 90 degrees relative to the reference plane of the endoscope or other feeding device 14; however, alternative embodiments may be configured with other geometric shapes (e.g., closed to less than 45 degrees and / or open to more than 90 degrees).

[0116] The cap plate 84 includes a mechanism for capturing the magnetic anastomosis device 16. In this example, the cap plate 84 includes one or more magnets 85 for capturing the magnetic anastomosis device 16, however, in various alternative embodiments, other mechanisms (e.g., mechanical or electromechanical devices capable of gripping or holding the anastomosis device 16, adhesive components capable of fixing the anastomosis device, etc.) may be used. Note that the magnets 85 may include electromagnets, which enable the provision of a constant or variable magnetic field strength, thereby generating a range of magnetic field strengths for capturing, holding, and releasing the compression anastomosis device over a given range of conditions (e.g., various device sizes, various device magnetic configurations, various tissue types / thicknesses, etc.).

[0117] In some embodiments, the cap body 83 may have channels 99 for allowing fluid and / or air to pass through the cap body 83. This may be done to maintain visibility through the cap body and / or to maintain suction of the endoscope 14.

[0118] In the example shown in Figure 47, pressure applied to the extension at the bottom of the cap plate 84 causes the cap plate 84 to move from a closed position to an open position relative to the cap body 83. This pressure can be generated, for example, by pressing the device against tissue or the other magnetic anastomosis device 16.

[0119] Additionally or alternatively, a force generated by interaction with an opposing magnetic anastomosis device 16 may move the cap plate 84 from a closed position to an open position relative to the cap body 83, for example, when the first magnetic anastomosis device being delivered interacts with the previously delivered magnetic anastomosis device as the distance between the two magnetic anastomosis devices decreases.

[0120] Additionally or alternatively, the cap may include an actuation mechanism for controlling the position of the cap plate 84 relative to the cap body 83. Figure 48 shows one form of actuation mechanism including a control guide 88 that can be actuated to control the position of the cap plate 84, but other mechanisms may be used in various alternative embodiments (e.g., mechanical, electromechanical, etc.).

[0121] In some exemplary embodiments, the cap may be configured to allow for a greater degree of motion, either additionally or alternatively. Figure 49 shows a universal joint 91 including a pivot hinge that provides three degrees of freedom, but other mechanisms may be used in various alternative embodiments (e.g., hinges, ball joints, etc.). Note that any actuation mechanism included generally allows for control of the position and movement of the cap over any desired range of motion.

[0122] For example, as shown in Figure 46, the cap 83 and plate 84 may provide an opening 92 to allow material or fluid to pass through the cap and to prevent visual or material obstruction when joining the anastomosis device 16 or otherwise forming an anastomosis.

[0123] As described above, in preferred embodiments, the detection and holding forces of the devices are optimized so that the compression anastomosis device is released or can be released only when properly coupled, and so that improperly coupled devices can be separated, realigned, and properly coupled. Thus, the cap is generally configured to have a predetermined holding force for a particular compression anastomosis device 16, and this predetermined holding force may be configured or otherwise selected so that the compression anastomosis device 16 can be released only when the coupling force with the other compression anastomosis device 16 is greater than the holding force. When the coupling force is greater than the holding force, the compression anastomosis device 16 can be released from the cap automatically or when the feed device 100 is retracted. The holding force can be controlled in any variety of ways, for example, but not limited to, the number of magnets or metal members 85 in the cap, the size of the magnets or metal members 85 in the cap, the strength of the magnets 85 in the cap, the material of the cap / plate 84, and the method of fixing one or more magnets or metal members 85 to the cap / plate (e.g., attaching them to the cap, embedding them in the cap, etc.). The bonding force can also be influenced by many factors, including but not limited to the configuration of the compression anastomosis device 16, the type / thickness of the tissue, and blood flow or perfusion. Exemplary embodiments may include various caps having various configurations and sizes (e.g., outer diameter) for use with various target devices, tissue types / thicknesses, etc. In these exemplary embodiments, magnetic detection may be considered passive, as it is based on the configuration and interaction of the cap and the compression anastomosis device 16.

[0124] Additionally or alternatively, the retaining force can be achieved using mechanical or electromechanical components (e.g., gripping members), adhesives, or other components that hold the compression anastomosis device 16, unless the bonding force becomes greater than a predetermined level that overcomes the retaining force or otherwise releases the retaining mechanism. For example, the bonding force can be actively detected (e.g., using magnetic sensors, force sensors, etc.) and used to release the compression anastomosis device 16 (e.g., by mechanically or electromechanically opening the gripping members or physically separating the compression anastomosis device 16 from the cap). Thus, for example, if a magnetic field greater than X Gauss is detected, the compression anastomosis device 16 can be released. In some exemplary embodiments, the cap may additionally or alternatively include one or more sensors (e.g., thin-film sensors) that measure and detect various parameters such as force, pressure, and / or magnetic induction, as these relate to the bonding between the compression anastomosis devices. This may be used to provide real-time feedback to the user. The feedback may include light, sound, a screen, and / or other indicators.

[0125] Figure 50 is a schematic diagram showing a cap with one or more sensors communicating with an electronic interface 93 that can provide feedback to the user, according to one exemplary embodiment. Note that a similar mechanism can also be used in conjunction with an electronic actuator in the cap to electronically control, for example, the position and movement of the cap and / or the amount of trapping force (for example, to trap and release a magnetic anastomosis device). Therefore, for example, some embodiments may include one or more electronic sensors and / or one or more electronic actuators. Note that such sensors and / or actuators may be used in addition to, or in place of, an angled cap and / or a movable cap in some exemplary embodiments. In one embodiment, the cap may have a thin-film sensor in the cap plate 84 that measures and / or detects one or more parameters such as force, pressure and / or magnetic induction. This may be used to provide real-time feedback to the user. For example, a thin-film strain gauge 94 may transmit data on one or more parameters to the electronic interface 93 as feedback to the user. The feedback may include light, sound, a screen and / or other indicators.

[0126] Without limitation, the sensor system of the above type may be used to monitor the position of the captured anastomosis device relative to the corresponding anastomosis device, thereby notifying the user if the anastomosis device 16b is not properly positioned to engage with the corresponding anastomosis device 16a and / or preventing the release of the captured anastomosis device 16b. For example, in some exemplary embodiments, the sensor system may be configured to detect conditions in the form shown in Figure 51, for example, (A) in which the magnets 16a, 16b are arranged in a "Venn diagram", (B) in which the magnets 16a, 16b are arranged in a "figure eight", or (C) in which the magnets 16a, 16b are separated by a distance greater than a predetermined distance (e.g., greater than about 4 mm) due to, for example, tissue thickness or occlusion. Detection may be achieved, for example, by force, pressure and / or magnetic induction measurement.

[0127] Figure 52 shows an alternative cap configuration in which the cap is configured to open when extended from the opening of the shaft member 89 (e.g., by applying a spring load 90). Note that while this exemplary embodiment includes two opening members or spring members 90, the alternative embodiment may include more than two (e.g., three, four, etc.) opening members. The exemplary cap in Figure 52 includes one or more arms 300 for capturing one anastomosis device (two arms are shown, but one or more arms are possible). The cap has a working channel 92 along its entire length, which allows the magnetic device 16 and other materials to flow through the cap. In one embodiment, the cap is retracted at a 180-degree angle to the scope 14. When exiting the shaft member 83, the cap opens perpendicular to the scope 14 to capture the anastomosis device 16. The arms may be opened by a spring load member 90 or other actuation member that allows the cap to open at a 90-degree angle. The cap shown in Figure 52 may include any of the above-described components, such as a magnet 85 or other mechanism for capturing, selectively detecting, and releasing the anastomosis device based on the coupling force; a pivot mechanism that allows the captured anastomosis device to be oriented to a predetermined angle after capture; a universal joint or other mechanism that provides additional degrees of freedom; an actuator for controlling the position and movement of the cap; and / or an electronic sensor and / or electronic actuator.

[0128] Figures 54A to 54J show one exemplary flexible, operable feeding device, according to one exemplary embodiment, having an angled cap at its distal end for selectively feeding, capturing, and releasing a magnetic compression anastomosis device.

[0129] Figure 54A shows the compression anastomosis device before deployment. In this example, the cap plate 84 includes two magnets 85 for capturing the deployed compression anastomosis device or other devices. In this example, the cap plate 84 is stored at a 45-degree angle to the feeding device, such as the endoscope 14.

[0130] Figure 54B shows the compression anastomosis device 16 after deployment and self-assembly. The magnetic anastomosis device 16 is deployed from the feeder 14 through the hole in the cap plate 84. The magnets self-assemble to form a polygon, an octagon in this example, and are attached to the scope by the suture 60 or another control wire. At this point, the magnets 16 are not yet aligned or engaged with the cap plate 84.

[0131] Figure 54C shows a compression anastomosis device 16 captured by a magnet on an angled cap. The magnetic anastomosis device 16 is attracted to the cap plate 84 by magnetic attraction from a magnetic device 85 on the cap plate 84. The magnet 85 on the cap plate 84 attracts the magnetic anastomosis device 16 and connects the magnetic anastomosis device 16 to the cap plate 84 for manipulation and placement. The anastomosis device 16 may also be brought to the cap plate 84 by pulling back the suture 60 that attaches the magnetic device 16 to the scope 14.

[0132] Figures 54D to 54H show the sequence of operations of the flexible feeder guided by the operator at the proximal end of the feeder, and represent the vertical, horizontal, and rotational displacements of the distal end with the captured compression anastomosis device.

[0133] Figure 54D shows a magnetic anastomosis device 16 coupled to a cap plate 84 that is in a stowed position at a 45-degree angle to the endoscope 14.

[0134] Figure 54E shows a side view of the magnetic anastomosis device 16 coupled to a cap plate 84 in a stowed position at a 45-degree angle to the endoscope 14. In some embodiments, the cap plate 84 may be stowed at an angle other than 45 degrees, for example, at an angle perpendicular to the endoscope 14, or at an angle less than 45 degrees.

[0135] Figure 54F shows another side view of the magnetic anastomosis device 16 coupled to the cap plate 84, which is in a stowed position at a 45-degree angle to the end of the endoscope 14.

[0136] Figure 54G shows a flexible scope 14, such as an endoscope, which is used to operate the cap 83 attached to the anastomosis device 16. By bending the scope 14, the anastomosis device 16 can be manipulated to be positioned and aligned at the target anastomosis site.

[0137] Figure 54H shows a side view of a flexible scope 14 equipped with a capture device 83 including a cap plate 84 coupled to a magnetic anastomosis device 16. The cap plate 84 is in a retracted position at a 45-degree angle to the endoscope 14.

[0138] Figure 54I shows a simulation of the connection between the captured compression anastomosis device 16b and the corresponding compression anastomosis device 16a.

[0139] Figure 54J shows a simulation of the captured compression anastomosis device 16 being released from the feeder 14 based on the proper alignment of the two compression anastomoses, which generates a binding force that overcomes the retaining force generated by the cap 83 in the captured compression anastomosis device 16. The surgeon can pull back the feeder 14 to separate the cap plate 84 from the captured anastomosis device 16, thereby allowing the feeder 14 and cap 83 to be removed from the patient, leaving the compression anastomosis device behind.

[0140] Figure 53 shows a laparoscopic magnetic navigation device 95 for controlling the movement of a magnetic device 16 within the gastrointestinal tract or other lumen, according to several exemplary embodiments. The following are some exemplary configurations for such a laparoscopic magnetic navigation device.

[0141] (a) Iron laparoscopic tools - Tools equipped with balanced ferromagnetic masses are used to allow the magnet to be moved through the gastrointestinal tract starting from the stomach and pulled through the intestinal tract without causing damage. This is achieved by using a gap-controlling tip at the end of the laparoscopic wand. Maintaining the gap makes it possible to generate a sufficiently large force to displace the magnet in order to pull and manipulate through anatomical tortuosity without allowing the magnet and tool to "tighten" the tissue.

[0142] (b) Static magnetic field laparoscopic tools – Similar to iron tools, these must also be balanced mass approaches with sufficient attractive force to allow manipulation without constricting the tissue. The advantage of using a different magnet is the reduction in footprint and the mass of the laparoscopic wand.

[0143] (c) Electromagnetic Field Laparoscopy Tools - The use of variable magnetic field laparoscopy tools offers significant advantages. It has been proven difficult to navigate through challenging anatomical features such as the pylorus or any other narrow / sphincteric areas within the gastrointestinal tract. When the magnet approaches these anatomical structures, it can vibrate and push its way through, allowing for much better manipulation of the magnet without the concern of constricting tissue, while also providing an extremely powerful magnetic field. By pulse-driving the electromagnetic wand with different waveforms and patterns, the user can hold the magnet at a distance from the tip and levitate it through anatomical structures.

[0144] The distal end of the laparoscopic navigation device 95 may contain a magnet or ferromagnetic metal, so that when it captures the magnetic anastomosis device 16b, the attractive force between the two anastomosis devices 16a and 16b becomes stronger than the magnetic attractive force between the laparoscopic navigation device 95 and the captured magnet 16b. Therefore, since the attractive force between the laparoscopic device 95 and the captured magnet 16b is smaller than the attractive force between the pair of magnets 16a and 16b, the laparoscopic device can be easily removed from the patient without interfering with the placement of the pair of magnetic anastomosis devices 16a and 16b.

[0145] It should be noted that the magnetic navigation device of the form shown in Figure 53 substantially has a single point of contact or interaction focus with the cap of the compression anastomosis device 16 or other target device, and may include any of the above-mentioned components, such as a magnet or other mechanism for capturing, selectively detecting and releasing the anastomosis device based on coupling force, a swivel mechanism that allows the captured anastomosis device to be oriented to a predetermined angle after capture, a universal joint or other mechanism that provides additional degrees of freedom, an actuator for controlling the position and movement of the device, and / or an electronic sensor and / or electronic actuator.

[0146] Embedding by reference This disclosure includes references and citations to other documents, such as patents, patent applications, patent publications, journals, books, articles, and web content. Thus, all such documents are incorporated herein by reference in their entirety for any purpose.

[0147] Equal portions The present invention may be implemented in other specific forms without departing from its spirit or essential features. Therefore, the embodiments described above should be considered illustrative in all respects rather than limiting the invention described herein. Thus, the scope of the invention is indicated by the appended claims rather than by the above description, and all modifications that fall within the meaning and scope of equivalence of the claims are intended to be encompassed within the claims.

[0148] Potential Claims Various embodiments of the present invention may be characterized by potential claims enumerated in the paragraph following this paragraph (and before the actual claims provided at the end of this application). These potential claims form part of the description of the present application. The subject matter of the following potential claims may be presented as actual claims in subsequent proceedings, including this application or any application claiming priority thereunder. Such inclusion of potential claims should not be interpreted as meaning that the actual claims do not cover the subject matter of the potential claims. Thus, a decision not to present these potential claims in subsequent proceedings should not be interpreted as a donation of subject matter to the public. Nor are these potential claims intended to limit the various claims being claimed.

[0149] The potential subject matter that may be claimed without limitation (marked with the letter "P" to avoid confusion with the actual claims shown below) includes:

[0150] P1. A cap having an outer skirt for engaging with a shaft or tube member such as an endoscope, and having a surrounding elastic material for improving the clamp.

[0151] P2. A cap having a substantially transparent material in order to allow visibility of the cap.

[0152] P3. A device having the ability to capture and control a compression anastomosis device in the proximal lumen, allowing orientation at various angles relative to the feeding device, thereby enabling minimally invasive intraluminal translation and / or improvement of the connection position.

[0153] P4. A device having a detection force optimized to automatically release, separate, realign, and maintain sufficient retention force for improperly coupled devices that should be properly coupled.

[0154] P5. A cap capable of providing real-time feedback to the user.

[0155] P6. A cap having the ability to discern the type and / or thickness and / or blood flow or perfusion of tissue.

[0156] P7. A device, apparatus, and method for controlling and manipulating a magnet, using magnetic field detection to give the user confidence that the magnet has been deployed in such a way that a proper anastomosis is formed.

[0157] P8. Laparoscopic magnetic navigation system.

[0158] P9. The apparatus according to claim P8, wherein the apparatus is an iron laparoscope.

[0159] P10. The apparatus according to claim P8, wherein the apparatus is a static magnetic field laparoscope.

[0160] P11. The apparatus according to claim P8, wherein the apparatus is an electromagnetic field laparoscope capable of electromagnetically changing the magnetic field.

[0161] P12. Caps for feeding devices such as endoscopes, laparoscopes, and catheters, including any of the described features or combinations of features.

[0162] P13. A feeding device for endoscopes, laparoscopes, catheters, etc., having a cap that includes any of the described features or combinations of features.

[0163] P14. Devices such as endoscopes, laparoscopes, and catheters having a distal end containing a pivot member for selectively capturing, manipulating, and releasing a target device, based on any of the described features or combinations of features.

[0164] P15. An endoscope, laparoscope, catheter, or other device having a distal end containing a member for selectively capturing, manipulating, and releasing a target device, wherein the member is configured to release the target device only when the separating force on the target device is greater than the holding force of the member.

[0165] P16. An endoscope, laparoscope, catheter, or other device having a distal end containing a member for selectively capturing, manipulating, and releasing a target device, wherein the member is configured to release the target device only when the separation force on the target device is greater than a predetermined holding force.

[0166] P17. An endoscope, laparoscope, catheter, or other device having a distal end containing a member for selectively capturing, manipulating, and releasing a target device, wherein the member is configured to release the target device only when the magnetic field interaction with the target device is greater than a predetermined level.

[0167] P18. A device configured to capture and control a rigid magnet, thereby advancing the magnet to a position for anastomosis.

[0168] P19. A medical device having a distal end, said medical device is A cap, which includes a magnetizable portion, is configured to be attached to the distal end of the medical device. A first magnet for attachment to the magnetizable portion of the cap, The first force generated between the cap and the first magnet, A second magnet for attachment to the first magnet, wherein the second magnet has a second force between it and the first magnet. Includes, The second force is greater than the first force in order to separate the first magnet from the cap. Medical device.

[0169] P20. The apparatus according to claim P19, further comprising the ability to detect a magnetic force that captures and / or releases a magnetic anastomosis device.

[0170] P21. The apparatus according to claim P19, further comprising a cap made of a substantially transparent material so that the cap can be seen through.

[0171] P22. The apparatus according to claim P19, further comprising an internal working channel along the entire length of the cap so that a material can pass through the cap.

[0172] P23. The apparatus according to claim P19, further comprising a detection force optimized to automatically release a properly coupled compression anastomosis device and to maintain sufficient retention force for improperly connected devices that are to be separated, realigned, and properly coupled.

[0173] P24. The apparatus according to claim P19, further comprising the ability to provide real-time feedback to the user.

[0174] P25. The apparatus according to claim P19, further comprising the ability to determine the type and / or thickness and / or blood flow or perfusion of tissue.

[0175] P26. The apparatus according to claim P19, further comprising a control guide attached to the cap plate, which allows the cap plate to pivot relative to the cap body.

[0176] P27. The apparatus according to claim P19, further comprising a shaft member to which a spring load is applied in the cap body, which can release the cap plate from a stored position to an deployed position.

[0177] P28. The apparatus according to claim P19, further comprising one or more channels within the cap body having the ability to pass fluid and / or air through the cap body.

[0178] P29. The apparatus according to claim P19, further comprising one or more arms capable of capturing and operating a magnetic device.

Claims

1. A device for capturing and operating a magnetic compression anastomosis device, the device is The cap includes a cap for a feeder used to feed the magnetic compression anastomosis device, and the cap is, A cap body having a distal end and a proximal end, The cap body includes a pivot cap member coupled to the distal end, which is movable at least between a closed position and a fully open position and is configured to capture the magnetic compression anastomosis device, The device wherein the pivot cap member protrudes outward from the cap body.

2. The apparatus according to claim 1, wherein the proximal end of the cap is configured to be attached to the feeding device.

3. In the closed position, the pivot cap member is angled substantially by an angled distal end geometry, and In the fully open position, the pivot cap member is rotated away from the angled distal end geometry. The apparatus according to claim 1.

4. The apparatus according to claim 1, wherein the pivot cap member includes one or more magnets.

5. The apparatus according to claim 1, wherein the pivoting cap member includes at least one electromagnet configured to provide a constant or variable magnetic field strength.

6. The apparatus according to claim 1, wherein the pivot cap member includes at least one device capable of gripping or holding the magnetic compression anastomosis device.

7. The apparatus according to claim 1, wherein the pivot cap member includes at least one bonding device.

8. The apparatus according to claim 1, wherein the pivot cap member is coupled to the cap body using at least one pivoting means.

9. The apparatus according to claim 8, wherein the at least one pivoting means includes one or more pins.

10. The apparatus according to claim 8, wherein the at least one pivoting means includes at least one hinge.

11. The apparatus according to claim 8, wherein the at least one pivoting means includes at least one ball joint.

12. The apparatus according to claim 1, further comprising a biasing device configured to bias the pivot cap member toward the closed position.

13. The apparatus according to claim 12, wherein the biasing device includes one or more springs.

14. The apparatus according to claim 1, wherein the closed position is at an angle of approximately 45 degrees or less with respect to the reference plane of the feeding device.

15. The apparatus according to claim 1, wherein the fully open position is at an angle of approximately 90 degrees or more with respect to the reference plane of the feeding device.

16. The apparatus according to claim 1, wherein the pivot cap member includes an extension, and when pressure is applied to the extension, the extension moves the pivot cap member from the closed position toward the fully open position.

17. The apparatus according to claim 1, wherein the cap further includes an operating mechanism for remotely controlling the position of the pivot cap member relative to the cap body.

18. The apparatus according to claim 17, wherein the operating mechanism includes a spring load mechanism that can release the pivot cap member from the closed position to the fully open position.

19. The apparatus according to claim 1, wherein the cap body is movable relative to an adjacent cap body.

20. The apparatus according to claim 19, wherein the cap body includes a universal joint, hinge, or ball joint between adjacent cap bodies.

21. The cap body is movable relative to the feed device, and the cap body includes a universal joint, hinge, or ball-and-socket joint that is movable relative to the feed device. The apparatus according to claim 1, wherein the cap further includes an operating mechanism configured to remotely control the position of the distal end relative to the proximal end.

22. The apparatus according to claim 21, wherein the cap further includes at least one sensor that detects the position of the cap body and provides positional feedback to the user.

23. The apparatus according to claim 1, wherein the cap body is formed of a substantially transparent material in order to allow the cap to be seen through.

24. The apparatus according to claim 21, wherein the cap further includes an operating mechanism configured to remotely control the position of the distal end relative to the proximal end.

25. The apparatus according to claim 1, wherein the cap body includes at least one channel extending through the cap body.

26. The at least one channel is adapted to allow fluid and / or air to pass through the cap body. The at least one channel is fitted to allow the instrument to pass through the cap body, or The at least one channel is adapted to deliver the suction means through the cap body. The apparatus according to claim 25, comprising at least one of the following.

27. Furthermore, the apparatus according to claim 2, further comprising the feeding device, wherein the proximal end of the cap is attached to the feeding device.

28. Furthermore, the apparatus according to claim 1, further comprising the feeding device, wherein the cap is integrally formed on the feeding device.

29. The aforementioned feeding device is Endoscope, Laparoscopy, or catheter The apparatus according to claim 1, which is one of the following.

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