Systems, apparatus, and methods for forming anastomoses

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

[0001] Cross - Reference to Related Applications This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 191146, filed May 20, 2021, entitled SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES (Attorney Docket No. 121326 - 11600), 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 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 June 2, 2018, U.S. Provisional Application No. 62 / 798809, filed January 30, 2019, and U.S. Provisional Application No. 62 / 809354, filed 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 forming anastomoses 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] Various methods of the present invention may include the feeding device puncturing the proximal tissue wall toward the proximal lumen to form a bowel incision. The feeding device can then be advanced through the distal tissue wall of the proximal lumen to form an exit incision. The feeding device can then be advanced through the tissue wall of the distal lumen to form an entrance incision, thereby allowing it to enter the distal lumen. The distal compression anastomosis device can then be deployed from the feeding device into the distal lumen. The feeding device can then be retracted from the distal lumen through the entrance incision and into the proximal lumen through the exit incision. While in the proximal lumen, the proximal anastomosis device can be deployed from the feeding device into the proximal lumen. The control member can then be deployed into the proximal lumen through the feeding device. The proximal compression anastomosis device can be operated using the control member, thereby pressing the proximal anastomosis device against the tissue wall of the proximal lumen at a first target site and aligning the proximal anastomosis device with the distal anastomosis device. Subsequently, tension is applied to the pivotable tension member to bring the distal anastomosis device to a second target site against the tissue wall of the distal lumen, thereby allowing the anastomosis devices to be joined together to form an anastomosis. Then, the pivotable tension member is cut and retracted into the feeding device, thereby releasing the anastomosis device. Finally, the feeding device can be retracted into the body cavity through the intestinal incision from the proximal lumen and removed from the patient.

[0010] In some embodiments, the feeding device may be a laparoscope or an endoscope.

[0011] In some embodiments, the distal compression anastomosis device may be operated using a laparoscope.

[0012] In one embodiment, the proximal anastomosis device may be deployed in front of the distal anastomosis device.

[0013] Various methods of the present invention may include a feeding device advancing into the distal lumen by puncturing the tissue wall of the distal lumen, and deploying a distal compression anastomosis device from the distal end of the feeding device. A magnetaire device may then be deployed from the feeding device, so that its distal end is connected to a distal anastomosis device in the distal lumen, and its proximal end is in the body cavity outside the distal lumen. The feeding device can then be retracted from the distal lumen into the body cavity, and then advanced into the proximal lumen by puncturing the proximal tissue wall of the proximal lumen, thereby deploying a proximal compression anastomosis device. The feeding device may then puncture the distal tissue wall of the proximal lumen, thereby forming a distal enterotomy. The proximal end of the magnetaire device can be manipulated using a laparoscope and attached to the feeding device through the distal enterotomy. Next, the feeding device is retracted, thereby bringing the distal magnetic anastomosis device closer to the proximal anastomosis device, and thereby forming an anastomosis site between the distal magnetic anastomosis device and the proximal anastomosis device.

[0014] In some embodiments, the magnetail device may include one or more sutures, a balloon control member, a deployable / retractable umbrella control member, a cap control member, and / or a basket control member.

[0015] Various embodiments of the present invention may include a device for operating the placement of a compression anastomosis device, the device including a magnetail device, a compression anastomosis device at the distal end of the magnetail, a pulley mechanism or shaft member attached to the suture, and a pulley moving member at the proximal end attached to a pulley mechanism having the ability to extend or retract the suture in order to operate the compression anastomosis device.

[0016] In some embodiments, the control member includes one or more sutures. In some embodiments, the control member may be a balloon, an expandable / contractable umbrella, a cap, and / or a basket.

[0017] In various embodiments, the present invention may include a device for manipulating sutures and / or guide members within a patient, the device including a handle, the distal end of which may be connected to a conduit including, but not limited to, an endoscope or laparoscope. The handle may have a conduit running through its center, in which case the suture or guidewire extends through the conduit from the distal end to the proximal end. The handle may be fitted with one or more suture wheels that can manipulate the tension applied to the suture. In some embodiments, the handle may be fitted with a suture cutting button that can cut the suture. The handle may be fitted with a capture / release and / or locking mechanism that can maintain the tension applied to the suture and hold the suture in place.

[0018] Some embodiments of the present invention may include a device for the placement and control of a compression anastomosis device, comprising a wand member that can be deployed from a feeding device. The distal end of the wand member may be key-shaped or hook-shaped, which can engage with the compression anastomosis device. The wand member may have a conduit extending from the distal end to the proximal end, in which case one or more sutures extend through the conduit to control the compression anastomosis device. The wand member may have one or more magnets on its front surface on the proximal side of the hook, which are arranged linearly along the proximal axis to the distal axis and can engage with the compression anastomosis device to operate the placement of the device at a target site inside the patient. The magnets may have a magnetic force less than that of the compression anastomosis device, thereby allowing disengagement from the compression anastomosis device. The wand member can be retracted into the feeding device and removed from the patient. [Brief explanation of the drawing]

[0019] The features and advantages of the claimed subject matter will become apparent from the following detailed description of embodiments corresponding thereto, which will be discussed with reference to the attached drawings. [Figure 1] This is a schematic diagram of an anastomosis formation system consistent with the present disclosure. [Figure 2] This diagram shows several potential anatomical targets for anastomosis formation, with arrow A indicating stomach to small intestine, arrow B indicating small intestine to large intestine, arrow C indicating small intestine to small intestine, arrow D indicating large intestine to large intestine, and arrow E indicating stomach to large intestine. [Figure 3] This figure shows an exemplary magnetic anastomosis device being fed through an endoscopic instrument channel so that individual magnetic segments self-assemble to form a larger magnetic structure, an octagon in this particular case. [Figure 4A] This diagram shows two magnetic anastomosis devices attracting each other through tissue. As shown in the diagram, each device has eight magnetic segments, but alternative configurations are also possible. When the two devices are joined, the tissue trapped between them will necrose, creating the anastomosis site to be formed. Alternatively, the tissue joined by the devices may be perforated after the devices are joined, thereby immediately forming the anastomosis site. [Figure 4B] This diagram shows two magnetic anastomosis devices that connect through magnetic attraction to capture intervening tissue. In some cases, an endoscope may be used to cut the surrounding tissue. [Figure 5A] This diagram shows a needle that delivers a first magnetic device to a target area within a first portion of a hollow body. [Figure 5B] Next, this figure shows the second magnetic device deployed within the second portion of the hollow body adjacent to the target site. [Figure 6A] This figure shows the delivery of a magnetic assembly into the gallbladder using an ultrasound-guided needle. [Figure 6B] This figure shows a magnet assembly that connects to a second magnet assembly in the stomach or duodenum. [Figure 7] This figure shows a single guide member for deploying and operating a magnetic anastomosis device. [Figure 8A] This diagram shows the deployment of a self-closing magnetic anastomosis device equipped with multiple guide members. [Figure 8B] This diagram shows the deployment of a self-closing magnetic anastomosis device equipped with multiple 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] Figures 9, 10, 11, and 12 are diagrams showing various methods of accessing a target site, specifically various methods of accessing the gallbladder by endoscopic ultrasound - guided procedures. Figure 9 is a diagram showing the use of monopolar energy for puncturing and accessing the gallbladder. [Figure 10] It is a diagram showing the use of a fine needle aspiration (FNA) for puncturing and accessing the gallbladder. [Figure 11] It is a diagram showing the use of a spiral needle for puncturing and accessing the gallbladder. [Figure 12] It is a diagram showing the use of a guide wire passing through the bile duct. [Figure 13] It is a diagram showing an endoscope - ultrasound - 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 are diagrams showing various devices for fixing an access device and / or a delivery device to a target site in the gallbladder. Figure 14 is a diagram showing a T - bar member. [Figure 15] It is a diagram showing a nitinol coil (e.g., "pigtail"). [Figure 16] It is a diagram showing a balloon member of a catheter. [Figure 17] It is a diagram showing a Malecot catheter. [Figure 18A] It is a diagram showing the technique of sending a pair of magnetic anastomosis devices to access the gallbladder and form an anastomosis between the gallbladder tissue and the 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 the 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 the 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 the 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 the 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 the 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 20A] This figure shows a method of accessing the gallbladder via an ultrasound-guided access means using a high-temperature insertion tube that emits monopolar energy, and then sending a magnetic anastomosis device into the gallbladder via the high-temperature tube. [Figure 20B] This figure shows a method of accessing the gallbladder via an ultrasound-guided access means using a high-temperature insertion tube that emits monopolar energy, and then sending a magnetic anastomosis device into the gallbladder via the high-temperature tube. [Figure 20C] This figure shows a method of accessing the gallbladder via an ultrasound-guided access means using a high-temperature insertion tube that emits monopolar energy, and then sending a magnetic anastomosis device into the gallbladder via the high-temperature tube. [Figure 21A] 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 21B]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 21C] 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 21D] 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 21E] 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 22A] Figures 21A to 21E show one variation of the procedure and apparatus, in which the magnetic anastomosis device is pre-loaded into the distal end of the Malecot catheter of the delivery device, and as a result, when the Malecot end moves to a fixed position, the device is delivered and deployed. [Figure 22B] Figures 21A to 21E show one variation of the procedure and apparatus, in which the magnetic anastomosis device is pre-loaded into the distal end of the Malecot catheter of the delivery device, and as a result, when the Malecot end moves to a fixed position, the device is delivered and deployed. [Figure 22C] Figures 21A to 21E show one variation of the procedure and apparatus, in which the magnetic anastomosis device is pre-loaded into the distal end of the Malecot catheter of the delivery device, and as a result, when the Malecot end moves to a fixed position, the device is delivered 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 25A] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue). [Figure 25B]This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue). [Figure 25C] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue). [Figure 25D] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue). [Figure 25E] This figure shows a technique for accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue). [Figure 26A] Figures 25A to 25E illustrate one variation of the procedure and apparatus shown, in which 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 then enabling the feeding and deployment of the magnetic anastomosis device. [Figure 26B] Figures 25A to 25E illustrate one variation of the procedure and apparatus shown, in which 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 then enabling the feeding and deployment of the magnetic anastomosis device. [Figure 26C] Figures 25A to 25E illustrate one variation of the procedure and apparatus shown, in which 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 then enabling the feeding and deployment of the magnetic anastomosis device. [Figure 27A]Figures 25A to 25E show another variation of the procedure and apparatus, and rather than having a deployment sheath for advancing the self-assembling magnetic anastomosis device as described herein, the assembly shown in Figures 27A to 27C relies on depositing T-bars through an access needle, so that a group of T-bars self-assemble to form an array and, as a distal anastomosis device, connect to a proximal magnetic anastomosis device located on the opposite side, and then work to compress the tissue between them to form an anastomosis. [Figure 27B] Figures 25A to 25E show another variation of the procedure and apparatus, and rather than having a deployment sheath for advancing the self-assembling magnetic anastomosis device as described herein, the assembly shown in Figures 27A to 27C relies on depositing T-bars through an access needle, so that a group of T-bars self-assemble to form an array and, as a distal anastomosis device, connect to a proximal magnetic anastomosis device located on the opposite side, and then work to compress the tissue between them to form an anastomosis. [Figure 27C] Figures 25A to 25E show another variation of the procedure and apparatus, and rather than having a deployment sheath for advancing the self-assembling magnetic anastomosis device as described herein, the assembly shown in Figures 27A to 27C relies on depositing T-bars through an access needle, so that a group of T-bars self-assemble to form an array and, as a distal anastomosis device, connect to a proximal magnetic anastomosis device located on the opposite side, and then work to compress the tissue between them to form an anastomosis. [Figure 28A] This figure shows 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 28B] This figure shows 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 28C] This figure shows 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 29A] This figure shows 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 29B] This figure shows 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 29C] This figure shows 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 30A] This figure shows a 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 30B] This figure shows a 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 30C] This figure shows a 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 30D] This figure shows a 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 31A] This figure shows a set of magnetic segments, pre-packaged with unstable polarity and including 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 31B] This figure shows a set of magnetic segments, pre-packaged with unstable polarity and including 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 32A] This figure shows a method for accessing the gallbladder using an access device having a conductor including a "high temperature" tip that emits monopolar energy, via an ultrasound-guided access means, and then delivering pre-packaged magnetic segments, as shown in Figures 31A and 31B, into the gallbladder through a sheath. [Figure 32B] This figure shows a method for accessing the gallbladder using an access device having a conductor including a "high temperature" tip that emits monopolar energy, via an ultrasound-guided access means, and then delivering pre-packaged magnetic segments, as shown in Figures 31A and 31B, into the gallbladder through a sheath. [Figure 33A] This figure shows a method for accessing the gallbladder using an ultrasound-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 with a proximal magnetic anastomosis device located on the opposite side, and then works to compress the tissue between them to form an anastomosis. [Figure 33B] This figure shows a method for accessing the gallbladder using an ultrasound-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 with a proximal magnetic anastomosis device located on the opposite side, and then works to compress the tissue between them to form an anastomosis. [Figure 33C] This figure shows a method for accessing the gallbladder using an ultrasound-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 with a proximal magnetic anastomosis device located on the opposite side, and then works to compress the tissue between them to form an anastomosis. [Figure 34A] This figure shows a 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 34B]This figure shows a 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 37A] This is an enlarged side view showing an anvil / sharpening device and a sharpening / sharpening device for cutting sutures. [Figure 37B] This is an enlarged side view showing an anvil / sharpening device and a sharpening / 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 41A] This figure shows a removable suture assembly. [Figure 41B] This figure shows 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 second magnetic assembly being delivered 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 multiple magnetic segments being transported through a single conduit, according to one exemplary embodiment. [Figure 47] This is a schematic diagram showing details of a separator segment according to one exemplary embodiment. [Figure 48] This is a schematic diagram illustrating how the separator segments shown in Figure 47 may be used to deploy and control the magnetic segments of two magnetic compression anastomosis devices (magnets) according to one exemplary embodiment. [Figure 49] This is a schematic diagram showing a laparoscopic handle having control means for simultaneously controlling multiple (e.g., two) independent lines. [Figure 50A] This diagram schematically illustrates one exemplary procedure using the "Shish Kebab" concept. [Figure 50B] This diagram schematically illustrates one exemplary procedure using the "Shish Kebab" concept. [Figure 50C] This diagram schematically illustrates one exemplary procedure using the "Shish Kebab" concept. [Figure 50D] This diagram schematically illustrates one exemplary procedure using the "Shish Kebab" concept. [Figure 50E] This diagram schematically illustrates one exemplary procedure using the "Shish Kebab" concept. [Figure 51A] This diagram schematically illustrates another concept using two engageable feeders (referred to herein for convenience as “magnetaire” and “capturer”) according to one exemplary embodiment. [Figure 51B]This diagram schematically illustrates another concept using two engageable feeders (referred to herein for convenience as “magnetaire” and “capturer”) according to one exemplary embodiment. [Figure 51C] This diagram schematically illustrates another concept using two engageable feeders (referred to herein for convenience as “magnetaire” and “capturer”) according to one exemplary embodiment. [Figure 51D] This diagram schematically illustrates another concept using two engageable feeders (referred to herein for convenience as “magnetaire” and “capturer”) according to one exemplary embodiment. [Figure 51E] This diagram schematically illustrates another concept using two engageable feeders (referred to herein for convenience as “magnetaire” and “capturer”) according to one exemplary embodiment. [Figure 51F] This diagram schematically illustrates another concept using two engageable feeders (referred to herein for convenience as “magnetaire” and “capturer”) according to one exemplary embodiment. [Figure 52] This diagram schematically shows the components of a disposable magnetail according to one exemplary embodiment. [Figure 53] This diagram schematically illustrates multiple magnetail configurations according to various exemplary embodiments. [Figure 54] This diagram schematically illustrates an alternative concept (referred to as a "hybrid" approach) that uses one endoscope and one laparoscope (unlike the two endoscopes) according to one exemplary embodiment. [Figure 55] This diagram schematically illustrates the concept of a surgical handle featuring a suture control button. [Figure 56] This diagram schematically illustrates a control key for operating an anastomosis device according to one embodiment. [Figure 57A] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57B]This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57C] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57D] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57E] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57F] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57G] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57H] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57I] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment. [Figure 57J] This diagram schematically illustrates a control key concept for operating two magnetic anastomosis devices within two lumens, according to one embodiment.

[0020] 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.

[0021] 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 cancer, including gastric or colorectal cancer.

[0022] 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 across a predetermined tissue region of the combined thickness of the tissue walls at the target site, exerting a compressive force on the predetermined region to form the anastomosis.

[0023] 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, positioning and securing an access device, 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 delivering 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 this disclosure may assist in deploying at least one of a pair of magnetic anastomotic compression devices, then securing 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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 will be 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 and position the endoscope 14 at a desired anatomical location for forming an anastomosis. For example, the imaging modality 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. The surgeon can then rely on such visual representations when advancing the endoscope through the hollow body, thereby positioning the access device 14 in a portion of the tissue adjacent to another portion of the tissue at the target site, thereby ensuring that the magnetic device 16,200 is placed accurately.

[0028] It should be noted that the hollow bodies through which the access device 14 can pass include, but are not limited to, the stomach, gallbladder, pancreas, duodenum, small intestine, large intestine, intestinal tract, vascular system including veins and arteries, etc.

[0029] In some embodiments, a self-assembling magnetic device 16 is used to form a bypass within the gastrointestinal tract. Such bypasses may be used to treat cancerous obstruction, weight loss or obesity, or also to treat diabetes and metabolic diseases (i.e., metabolic surgery). Figure 2 shows various gastrointestinal anastomosis targets that can be addressed by the device 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 embodiments provide improved devices and techniques for minimally invasively forming anastomoses in the body, for example, within 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, such as gastric cancer or colorectal cancer.

[0030] For example, if the hollow body through which the access device 14 can pass is the intestinal tract of patient 12, 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 diseases. 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.

[0031] In endoscopic procedures, a self-assembling magnetic device can be advanced using a single endoscope 14. The deployment of the magnetic device 16 is schematically shown in Figure 3. As illustrated, the exemplary magnetic anastomosis device 16 is advanced through the endoscope 14, thereby allowing 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 more robust 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.

[0032] Since the magnetic device is radiopaque and echogenic, it can be positioned using fluorescence fluoroscopy, direct visualization (transillumination or tissue intrusion), and ultrasound, such as an endoscopic ultrasound. The device 16 may be decorated with radiopaque paint or other markers to help identify the polarity of the device during implantation.

[0033] The magnetic anastomosis device 16 generally includes multiple magnetic segments 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 to be guided through various curves in the body. Once delivered, the device automatically converts from the feed configuration to an unfolded configuration to take on the desired shape and size. The self-conversion from feed configuration to unfolded configuration is guided by coupling structures that allow the magnetic segments to move as desired without intervention. Exemplary self-assembling magnetic anastomosis devices 16, such as self-closing and self-opening types, are described in U.S. Patents 8,870,898, 8,870,899, 9,763,664 and 1,0182,821, the contents of which are incorporated herein by reference in their entirety.

[0034] 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 22 and 26, 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 to join the tissues 22 and 26. Over time, an anastomosis portion of the size and shape of the devices 16a and 16b is formed, and the devices detach from the tissue. In particular, the tissues 22 and 26 surrounded by the devices become necrotic and decompose, providing an opening between the tissues.

[0035] Alternatively, the joined devices 16a and 16b generate sufficient compressive force to stop blood flow to the tissues 22 and 26 trapped between them, so that the surgeon can form an anastomosis by creating an incision in the tissues 22 and 26 surrounded by the devices, as shown in Figure 4B.

[0036] 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.

[0037] 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 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. Such embodiments will be described in more detail herein.

[0038] As described above, the self-assembling magnetic anastomosis devices 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.

[0039] Figure 6A shows an ultrasound-guided needle being delivered into the gallbladder 302, where the magnetic assembly then connects with a second magnetic assembly in the stomach 300 or duodenum 301, 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 needle (EUS) can be used to facilitate transgastric or transduodenal access to the gallbladder 302 for placement of a self-assembling magnetic anastomosis device 16. Once access to the gallbladder 302 is achieved, various strategies can be used to maintain an open portal between the stomach 300 and the gallbladder 302 or between the duodenum 301 and the gallbladder 302. In another embodiment, gallstones can be retrieved and fluidized using the endoscope. For example, an anastomosis can be formed between the gallbladder 302 and the stomach using the method described. Once the gallbladder 302 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).

[0040] 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.

[0041] 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 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 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.

[0042] 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 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.

[0043] Figures 9 to 12 illustrate various methods for accessing the target site, specifically, various methods for accessing the gallbladder 302 by endoscopic ultrasound-guided procedures. Figure 9 shows the use of monopolar energy for puncture access to the gallbladder 302. An endoscopic ultrasound scope (EUS scope) 303 accesses the stomach 300 / duodenum 301. A high-temperature probe or guidewire 304 utilizing monopolar or bipolar energy punctures the tissue of the stomach 300 / duodenum 301 and gallbladder 302 to advance the anastomosis device 16.

[0044] Figure 10 shows the use of a fine-needle aspiration (FNA) to puncture and access the gallbladder 302. The FNA accesses the stomach 300 / duodenum 301, and a hypotube equipped with a cutting edge 305 punctures the tissue of the stomach 300 / duodenum 301 and the gallbladder 302, thereby advancing the anastomosis device 16.

[0045] Figure 11 shows the use of a spiral needle 306 to puncture and access the gallbladder 302. The EUS scope 303 accesses the stomach 300 / duodenum 301. The spiral needle 306 punctures the tissue of the stomach 300 / duodenum 301 and the tissue of the gallbladder 302, thereby advancing the anastomosis device 16.

[0046] Figure 12 shows the use of a guidewire 308 passing through the bile duct 307. The guidewire 308 accesses the stomach 300 / duodenum 301. The guidewire 308 punctures the tissue of the stomach 300 / duodenum 301 toward the bile duct 307 in order to advance the anastomosis device 16 into the gallbladder 302.

[0047] Figure 13 shows an ultrasound-guided needle 303 that punctures the gallbladder 302 to access its interior, and then delivers the magnet assembly 16 into the gallbladder 302.

[0048] Figures 14, 15, 16, and 17 show various devices for fixing the access device and / or feeding device 14 to the target site in the gallbladder 302.

[0049] Figure 14 shows the T-bar member 310 anchored to the feeder by a tether 311, which acts as a fixing device for aligning tissues 22 and 26.

[0050] Figure 15 shows a nitinol coil 312 (e.g., a "pigtail") that acts as a fixation device to join the tissues 22 and 26 together.

[0051] Figure 16 shows the balloon member 313 of the catheter, which acts as a fixation device to join the tissues 22 and 26 together.

[0052] Figure 17 shows the Malecot catheter 314, which acts as a fixation device for joining tissues 22 and 26.

[0053] Figures 18A to 18F illustrate a method of accessing the gallbladder 302 via an ultrasound-guided access means 303 and using an access device that emits monopolar energy, fixing a delivery device 15 using a balloon catheter 313, and then advancing a pair of magnetic anastomosis devices 16a, 16b within the balloon 313 while fixing the balloon 313 within a jejunal incision formed between the tissue of the gallbladder 302 and adjacent tissue (i.e., the tissue of the stomach 300 or duodenum 301), thereby deploying the devices 16a, 16b on both sides of each tissue (i.e., the first device 16a in the gallbladder 302 and the second device 16b in the stomach 300 or duodenum 301) to form an anastomosis between them.

[0054] Figure 18A shows an EUS scope 303 that accesses the stomach 300 / duodenum 301 and a monopolar energy tip 304 that punctures the tissue 26 of the stomach 300 / duodenum 301 toward the tissue 22 of the gallbladder 302 in order to deliver an anastomotic device into the tissue 22 of the gallbladder 302.

[0055] Figure 18B shows a cross-section of the feeding device 15. The monopolar energy tip 304 punctures the tissue 26 of the stomach 300 / duodenum 301 toward the tissue 22 of the gallbladder 302. The device 15 is positioned within the intestinal incision between the tissues. Within the feeding device 15, the magnetic anastomoses 16a,16b are folded within the balloon catheter 313 in the sheath 315 within the feeding device 15. The conductor 316 is later used to remove the sheath 315 and stabilize the balloon catheter 313 in place.

[0056] Figure 18C shows the sheath 315 being removed from the balloon catheter 313 in order to position and inflate the catheter 313 within the intestinal incision.

[0057] Figure 18D shows the sheath 315 completely removed and the balloon catheter 313 being inflated by the inflation line 317. The anastomotic devices 16a and 16b, which were compressed once, expand within the lumen.

[0058] Figure 18E shows a cross-section of a fully inflated balloon catheter 313. The “donut”-shaped balloon has a narrow bore or internal channel 318 to allow fluid or other material to flow through the anastomosis.

[0059] Figure 18F shows the balloon catheter 313 fully deployed after being inflated by the inflation line 317. Once the balloon 313 is fully inflated, the monopolar energy tip 304 is removed, leaving the catheter 313 and the anastomosis devices 16a and 16b.

[0060] Figure 19 shows one modification of the design shown in Figures 18A to 18F, specifically, using balloon 313 to deliver a single magnetic anastomosis device 16 into the gallbladder 302 rather than a pair.

[0061] Figures 20A to 20C illustrate a method of accessing the gallbladder 302 via an ultrasound-guided access means 303 using a high-temperature insertion tube 304 that emits monopolar energy, and then sending a magnetic anastomosis device 16 into the gallbladder 302 via the high-temperature tube 304. As shown in Figure 20B, the user only needs to activate the monopolar energy to advance the insertion tube 304 into the gallbladder 302.

[0062] Figure 20A shows an EUS scope 303 that accesses the stomach 300 / duodenum 301 and utilizes a high-temperature insertion tube 304 to access the gallbladder 302 in order to deliver an anastomotic device 16 into the gallbladder 302.

[0063] Figure 20B shows the operation of the monopolar energy tip 319, which advances the insertion tube 304 to access the gallbladder 302.

[0064] Figure 20C shows the distal tip of the feeding device 15 that deploys the magnetic anastomosis device 16a.

[0065] Figures 21A to 21E show a method of accessing the gallbladder 302 via an ultrasound-guided access means 303 and using an access device 14 having a conductor 316 including a "high-temperature" tip 304 that emits monopolar energy, fixing the delivery device using a Malecot catheter 314, and then using the Malecot catheter 314 as a conduit for delivering the magnetic anastomosis device 16a into the gallbladder 302 through the Malecot catheter 314, while fixing the Malecot catheter 314 within the intestinal incision formed between the gallbladder tissue 22 and adjacent tissue 26 (i.e., stomach or duodenal tissue).

[0066] Figure 21A shows an EUS scope 303 that accesses the stomach 300 / duodenum 301 and uses a high-temperature insertion tube 304 to access the gallbladder 302, thereby delivering an anastomosis device 16a into the gallbladder 302.

[0067] Figure 21B shows how to access the gallbladder 302 via an EUS-guided access means 303 and using an access device 14 having a conductor 316 including a “high-temperature” tip 304 that emits monopolar energy, and how to fix the delivery device 15 using a Malecot catheter 314, and then use the Malecot catheter 314 as a conduit to deliver the magnetic anastomosis device 16a into the gallbladder 302 through the Malecot catheter 314, while fixing the Malecot catheter 314 within the intestinal incision formed between the gallbladder tissue 22 and adjacent tissue 26 (i.e., the tissue of the stomach 300 or duodenum 301). The user pulls back the access device 14 to open the magnets 16a,16b (Figure 21C) and advances the tip 304 (Figure 21D).

[0068] Figure 21E shows that the magnetic anastomosis device 16 can be deployed through the end of the access device 14 or through the window of the catheter 314. In some embodiments, the window of the catheter 314 may be radiopaque to maintain a suitable orientation.

[0069] Figures 22A to 22C show one variation of the procedure and apparatus shown in Figures 21A to 21E, in which the magnetic anastomosis device 16a is pre-loaded into the distal end of the Malecot catheter 314 of the feeding device 15, so that when the end of the Malecot 314 moves to a fixed position, the device 16a is fed and deployed.

[0070] Figure 22A shows a magnetic anastomosis device 16a that is pre-loaded inside the distal end of the Malecot catheter 314 of the delivery device 15, along with a suture 320 that fixes the magnet 16a inside the delivery device 15.

[0071] Figure 22B shows how the user pulls back the suture 320 when the end of the Malecot 314 moves to a fixed position, resulting in the feeding and deployment of the device 16a.

[0072] Figure 22C shows a method of cutting the suture 320 within the window of the Malecot catheter 314 by pressing the feeding device 15 forward.

[0073] Figure 23 shows a Malecot catheter 314 having a distal end that expands within a fixed position on one side of the gallbladder tissue wall 22.

[0074] Figure 24 shows a Malecot catheter 314 having distal ends that expand into fixed positions on both sides of the gallbladder tissue wall 22. In any example, a temporary Malecot 314 can be placed inside the gallbladder 302 to form a temporary conduit, which allows for immediate drainage and also enables ventilation of the gallbladder 302. Note that any embodiment providing means of access from the gastrointestinal tract to the gallbladder 302 (e.g., Malecot 314, high-temperature tube 305, Nitinol coil 312, balloon 313), 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 from any material in the gallbladder 302 can be drained (either by itself or when aspiration is applied). The channel may also be used to push fluid into the gallbladder 302 before it is emptied from the gallbladder (potentially performing multiple filling / emptying cycles), thereby "cleansing" the gallbladder 302 if it has excess fluid and contents (i.e., bile or other contents) inside.

[0075] Figures 25A to 25E show a method of accessing the gallbladder 302 via an ultrasound-guided access needle access means 303, fixing the feeding device 15 using the T-bar 310 assembly and stabilizer member 321, and then feeding the magnetic anastomosis device 16 into the gallbladder 302 via the deploying sheath 315 through the stabilizer member 321, while fixing the T-bar 310 within the intestinal incision formed between the gallbladder tissue 22 and adjacent tissue 26 (i.e., the tissue of the stomach 300 or duodenum 301).

[0076] As shown in Figure 25A, the T-bar 310 is anchored to the gallbladder wall 22. Then, as shown in Figure 25B, the stabilizer member 321 is advanced to the wall of the duodenum 301 or stomach 300 for traction. Then, as shown in Figure 25C, the deployment sheath 315 is advanced into the gallbladder 302, where the magnetic anastomosis device 16a can be advanced.

[0077] Figure 25C shows a stabilizer member 321. The stabilizer member 321 is advanced toward the wall of the duodenum 301 or stomach 300 for traction. Then, as shown in Figure 25D, the deployment sheath 315 is advanced into the gallbladder 302, where the magnetic anastomosis device 16a may be deployed. In some embodiments, the system can be rotated to assist in the deployment of the magnetic anastomosis devices 16a, 16b.

[0078] Figure 25E shows a fully formed magnetic anastomosis device 16a surrounding the T-bar 310. In some embodiments, the T-bar 310 may be metallic and be attracted to and adhere to the magnet 16a.

[0079] Figures 26A to 26C show one variation of the procedure and apparatus shown in Figures 25A to 25E, in which the deployment sheath 315 has a notch 322 at its distal end, the notch 322 engaging with the T-bar 310 as it advances through the intestinal incision, thereby pressing the T-bar 310 laterally and then enabling the feeding and deployment of the magnetic anastomosis device 16.

[0080] Figure 26A shows that the deployment sheath 315 has a notch 322 at its distal end, which is configured to engage with the T-bar 310 as it advances through the intestinal incision.

[0081] Figure 26B shows a notch 322 in the deployment sheath 315 that presses the T-bar 310 laterally, thereby enabling the subsequent feeding and deployment of the magnetic anastomosis device 16.

[0082] Figure 26C shows the magnetic anastomosis device 16 deployed with the T-bar 310 pressed laterally.

[0083] 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 310 through an access needle 309, rather than having a deployment sheath 315 for advancing the self-assembling magnetic anastomosis device 16 as described herein. The T-bars 310 are configured to self-assemble to form an array and, as a distal anastomosis device 16a, connect to a proximal magnetic anastomosis device 16b located on the opposite side, and then work to compress the tissues 22,26 between them to form an anastomosis.

[0084] Figure 27A shows the assembly of the T-bar 310 being fed through the access needle 309. In some embodiments, the T-bar 310 is magnetic. By retracting the feeder 14, the user can deploy the T-bar 310 into the lumen. The T-bar 310 is secured in place by the suture 320.

[0085] Figure 27B shows the magnetic array of the fully deployed T-bar 310. In this embodiment, the T-bar 310 is magnetic and can be attracted to the proximal anastomosis device 16b. By pulling the suture 320, the user can move the array of T-bar 310 toward the proximal anastomosis device 16b, thereby forming an anastomosis there.

[0086] Figure 27C shows an array of T-bars 310 and sutures 320 linearly loaded within an access needle 309. Linear loading of the T-bars 310 enables minimally invasive formation of the anastomosis. Because the magnetic assemblies 310,16b are linearly loaded and then self-assemble, the resulting aspect ratio of the anastomosis may be greater than 1:1. This is because the magnetic assemblies 310,16b assemble to a size larger than the diameter of the access needle 309. This allows for the formation of a larger anastomosis while still maintaining a minimally invasive procedure.

[0087] Figures 28A to 28C show how to access the gallbladder 302 via an ultrasound-guided access needle access means 303 using a side port deployment sheath 315 to advance and deploy a pair of magnetic anastomosis devices 16a and 16b.

[0088] Figure 28A shows how to access the gallbladder 302 to deploy the distal magnetic anastomosis device 16a. The feeding device 15 accesses the stomach 300 / duodenum 301 and punctures the gastric tissue wall 26 toward the gallbladder 302. This feeding device 15 has a side port 322 for deploying the proximal magnetic anastomosis device 16b.

[0089] Figure 28B shows a rotating ring 323 with a metal insert 324, consistent with several embodiments of the present invention. The rotating ring 323 can rotate about the shaft of the feeder 15. When the magnetic devices 16a, 16b are deployed from the side port 322 of the feeder 15, the metal insert 324 provided in the rotating ring 323 captures the magnetic devices 16a, 16b and guides the magnets 16a, 16b out of the feeder 15 around the shaft of the feeder 15, thereby assisting the self-assembly of the magnetic anastomose devices 16a, 16b. In some embodiments, the rotating ring 323 may rotate freely or rotate when the magnets 16 are pushed out of the feeder 15. In some embodiments, the rotating ring 323 may be actively rotated to pull the magnetic devices 16 out of the feeder 15.

[0090] Figure 28C is an enlarged view of the rotating ring 323 mounted on the shaft of the feeder 15. In some embodiments, the rotating ring 323 may be made of metal.

[0091] Figures 29A to 29C show a knotting member 325 configured to fix the already deployed and positioned magnetic anastomosis devices 16a and 16b to the target tissue 22 and 26, and then cut the guide member or suture 320 to which they are connected. As shown in Figure 29A, the knotting member 325 is placed over the guide member 320 and advanced within the working channel of the scope 14. The guide member 320 is positioned in the stomach 300 through the patient 12 and connected to the gallbladder 302 and the pre-positioned anastomosis devices 16a and 16b within the stomach 300.

[0092] As shown in Figure 29B, the knotting member 325 moves toward the magnetic anastomosis devices 16a and 16b. In this case, the knotting member 325 generally consists of an outer tube member 326 and an inner rod member 327. When it reaches the devices 16a and 16b, the inner rod member 327 is pressed toward the distal end of the outer tube member 326, thereby fixing a portion of the guide member 320 between the outer tube member 326 and the inner rod member 327. Furthermore, the guide member 320 can be cut during this process.

[0093] Figure 29C shows the magnetic anastomosis devices 16a and 16b fully advanced, which fix the guide member 320 and further show the knotting member 325 that cuts the guide member 320.

[0094] Figures 30A to 30D show a method for accessing the gallbladder 302 by an ultrasound-guided access needle access means 303 and advancing a magnetic coil 328 or ring, which is configured to transition substantially linear to substantially annular when advanced into the gallbladder 302, 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 tissues 22,26 between them to form an anastomosis.

[0095] Figure 30A shows a feeding device 15 that accesses the stomach 10 and deploys a magnetic coil 328 or ring, which acts as a distal anastomosis device, through the stomach tissue wall 26 into the gallbladder 302.

[0096] Figure 30B shows enlarged views of the magnetic coil 328 or ring in annular and linear positions. The magnetic device 328 is loaded into the feeder 15 in the linear position. Once deployed, the magnetic device 328 self-assembles into a coil or ring shape, thereby functioning as a distal magnetic anastomosis device. In some embodiments, the coil 328 is a laser-cut hypotube that allows the magnetic device 328 to bend.

[0097] Figure 30C shows a hypotube magnetic device 328 deployed into the distal lumen 329 by a nitinol wire or pigtail wire 312. The nitinol wire 312 penetrates the tissue wall 26 of the stomach and punctures toward the gallbladder 302, thereby advancing the distal anastomosis device, in this embodiment, the magnetic hypotube 328.

[0098] Figure 30D shows the proximal magnet 16b coupled to the magnetic hypotube 328. Once unfolded, the hypotube 328 self-assembles into a ring. Based on the corresponding polarities of the proximal magnet 16b and the distal magnet 328, the magnets 16b and 328 bond together, compressing the tissues 22 and 26 between them, thereby forming an anastomosis.

[0099] Figures 31A and 31B show a pair of magnetic segments 202,204, pre-packaged with unstable polarity and including multiple guide members 30, tethers, or sutures 320 that connect adjacent segments to each other to facilitate self-assembly of the magnetic segments into a polygonal unfolded shape.

[0100] Figure 31A shows a pair of magnetic segments 202,204, pre-packaged with unstable polarity and including multiple guide members 30, tethers, or sutures 320 that connect adjacent segments 202,204 to each other to facilitate self-assembly of the magnetic segments 202,204 into a polygonal unfolded shape.

[0101] Figure 31B shows the self-assembled magnetic anastomosis device 16. When unfolded from the feeding device 15, the magnetic anastomosis device 16 self-assembles into a polygon. The magnetic segments 202 and 204 are supported by the guide member 30 in their unfolded polygonal shape.

[0102] Figures 32A and 32B illustrate a method of accessing the gallbladder 302 by an ultrasound-guided access means 303 using an access device 15 having a conductor including a "high temperature" tip 304 that emits monopolar energy, and then sending the pre-packaged magnetic segments 202 and 204 shown in Figures 31A and 31B into the gallbladder 302 via a sheath 315.

[0103] Figure 32A shows the EUS scope 303 being guided into the stomach 300. The scope 303 deploys a "high-temperature" tip 304 that uses monopolar energy to penetrate the tissue 26 of the stomach 300 and puncture the gallbladder 302 via the sheath 315.

[0104] Figure 32B shows an enlarged view of the deployment mechanism of the "high-temperature" tip 304. The "high-temperature" tip 304 uses monopolar energy to puncture the stomach tissue 26 toward the gallbladder 302. The sheath 315 is loaded with a distal magnet 16a, a spacer 331, and a proximal magnet 16b. When the user pulls back the feeding device 15, the distal magnet 16a is deployed and self-assembles within the distal lumen 329.

[0105] Figures 33A to 33C illustrate how the gallbladder 302 is accessed by an ultrasound-guided access means 303 using a needle 309 to access the gallbladder 302, and then a rolled stack of magnetic segments 328 is advanced, configured so that the distal anastomosis device connects with the proximal magnetic anastomosis device 16b located on the opposite side, and then works to compress the tissue between them to form an anastomosis. As shown in Figure 33A, the nitinol coil 312 is advanced into the gallbladder 302. The magnetic segments 328 are then advanced around the expanded nitinol coil 312, as shown in Figure 33B. When the suture 320 is pulled, the magnetic segments 328 fold together (based on magnetic attraction), as shown in Figure 33C, and when the nitinol coil is removed, a rolled stack of magnets is formed.

[0106] Figures 34A to 34B show a method of accessing the gallbladder 302 by an ultrasound-endoscopic-guided access means 303 using a needle 309 for accessing the gallbladder 302, and then delivering a magnetic fluid 332 or a suspension of magnetic particles 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.

[0107] Figure 34A shows an EUS scope 303 accessing the stomach 300. A puncturing access needle 309 punctures the stomach tissue 26 toward the gallbladder 302, delivering magnetic fluid or magnetic particles 332 into the gallbladder 302.

[0108] Figure 34B shows that when the magnetic particle 332 approaches the proximal magnet 16b, it is attracted to the proximal magnet 16b, compressing the tissues 22 and 26 between them and forming an anastomosis.

[0109] Figure 35 shows a magnetic anastomosis device 16 that includes a continuous guide member 30 or suture 320 coupled to the multiple magnetic segments 202,204 of the device via eyelets 333 located on each of the multiple magnetic segments 202,204. The magnets 16 have eyelets 333 on their inner surfaces to prevent the suture 320 from becoming trapped or pinched between the magnets 16. The suture 320 extends through the eyelets 333 and has multiple legs 334(1)-(3) that can be pulled individually or simultaneously by the user to operate the magnets 16. To remove the suture 320, legs 334(1) and 334(3) may be pulled individually.

[0110] Figure 36 shows one embodiment of a suture cutting device in the deployment sheath 315 of the feed device 15 or a secondary device for cutting sutures 320 coupled to magnetic anastomosis devices 16a, 16b. The user pushes / pulls the feed device 15 to expose the anvil 335 and sharp cutting edge 336 for cutting the sutures 320. When tension is applied to the sutures 320 and the sutures 320 are pulled past the anvil 335 and sharp cutting edge 336, the sutures 320 are cut. In another embodiment, the user may twist the feed device 15, thereby exposing the sharp cutting edge for cutting the sutures 320.

[0111] Figures 37A and 37B are enlarged side views showing the anvil 335 / sharp 336 device and the sharp 336 / sharp 336 device for cutting sutures 320.

[0112] Figure 37A shows a deployable sheath 315 that utilizes a push / pull guillotine method to combine the anvil 335 / sharp 336 system to cut the suture 320. By pressing the deployable sheath 315, the blade is exposed, and tension is introduced into the suture 320 by pulling it. The tensioned suture 320 is then pulled past the sharp blade 336 and cut.

[0113] Figure 37B shows the Sharp 336 / Sharp 336 system, in which the blade is exposed by pressing the deployment sheath 315, and tension is introduced by pulling the suture 320. The tensioned suture 320 is then pulled past the sharp blade 336 and cut.

[0114] Figure 38 shows a snare device 337 (secondary device) configured to be inserted over a guide member 30 or suture 320 coupled to magnetic anastomosis devices 16a, 16b, and configured to cut the suture 320 or guide member 30 once the suture 320 or guide member 30 has been unfolded and positioned at the target site.

[0115] Figure 39A shows a snare device including a resistance heating member for cutting the guide member. The snare device 337 is guided through a support tube of the access device 14. Once the snare device 337 is placed over the suture 320 and positioned in place, the snare device 337 is pulled back to apply energy, which cuts the suture 320. The applied energy may be a low voltage from a battery or generator.

[0116] Figures 39B and 39C show a snare device including a ring member having a cutting edge for cutting the guide member 30.

[0117] Figure 39B shows a snare device 337 positioned outside the scope 14, but which may be incorporated into the scope cap, within a snare sleeve 338 advanced into the stomach 300. By withdrawing the scope 14, the user can advance the snare device 337 over the suture 320 attached to the magnet 16 deployed by the deployment means 315, and cut the suture 320.

[0118] Figure 39C shows a cross-sectional view of a snare device 337, which includes a ring member 339 having a cutting edge for cutting the suture thread 320. By pulling back the snare sleeve 338, the ring 339 with the cutting edge cuts the suture thread 320.

[0119] Figure 39D shows a secondary device configured to use monopolar / bipolar energy to cause cutting of the suture 320 or guide member 30. The monopolar tip 304 is advanced toward the tissue 26 and cuts the suture 320 attached to the deployed magnetic anastomosis device 16.

[0120] Figure 40 shows a detachable guide member 30 or suture 320. In one exemplary embodiment, the suture has a diameter-reduced or weakened region 340. By pulling back the suture 320, the suture 320 separates from the deployed anastomosis device 16.

[0121] Figures 41A and 41B show a removable suture assembly. Inside the sheath 315 are interlocking overmolded drivers 341 attached to the suture 320. The drivers 341 may be arranged alternately to fit inside the sheath 315 as shown in Figure 41A, or they may be located within individual lumens. By removing the sheath 315, the overmolded drivers 341 are no longer interlocked and are separated as shown in Figure 41B.

[0122] 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.

[0123] 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.

[0124] 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, within 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 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 between adjacent organs using minimally invasive technique, bridging the tissue walls of each organ and thereby forming a passage (i.e., an anastomosis) between them. The delivery device 100 is particularly useful in delivering a pair of magnetic assemblies to a target site within 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.

[0125] 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, 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.

[0126] 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.

[0127] During the procedure, a surgeon or other skilled medical professional can advance a scope (e.g., an endoscope) into the patient's hollow body and position the scope 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 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 and the wall of the common bile duct) in any of the manner described herein. When the distal end 104, including the slot 106, is advanced into the first organ (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 through the slot. For example, Figure 43C shows the first magnetic assembly 200a being fed into the common bile duct. As shown in the figure, the retaining member 108 includes a connecting member 110 at its distal end, and the connecting member 110 is configured to be removably coupled to the corresponding connecting member of the central portion 208 of the exoskeleton 206 (indicated by the mounting point arrow). As the retaining member 108 is advanced and expanded toward the distal end 104 of the feeder 100, the first magnetic assembly transitions to an unfolded state, as shown in Figure 43D, by passing through the slot 106 from the working channel of the feeder 100. As shown in the figure, 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 feeder 100, while the central portion 208 of the exoskeleton 206 remains within the slot 106. In other words, the slot 106 extends as a whole through the body 102 of the feeder 100 from one side to the other. Therefore, when in the deployed state, the first magnetic assembly 200a is positioned within the first organ while remaining held within the slot 106 of the feeder 100.

[0128] 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. The surgeon can then feed and deploy the second magnetic assembly 200b into the second organ (i.e., the duodenum). Figure 43E shows the first magnetic assembly 200a fully deployed within the first organ, and retracting the feeder 100 draws the first magnetic assembly 200a towards the wall of the common bile duct in preparation for the feeding and deployment of the second magnetic assembly 200b into the duodenum.

[0129] 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.

[0130] 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, forcibly separating the two halves of the distal end 104, 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. The pair of magnetic assemblies 200a, 200b compress the walls of each organ between them, then form an anastomosis between the organs (i.e., the anastomosis between the duodenum and the common bile duct).

[0131] 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.

[0132] For example, the design of magnetic assemblies, particularly the coupling of multiple magnetic segments via an exoskeleton, allows for any number of segments to be included in a single assembly, resulting in the resulting anastomosis having a larger size relative to the dimensions of the scope's working channel. For example, in some embodiments, the resulting anastomosis may have an aspect ratio in the range of 2:1 to 10:1 or greater.

[0133] 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.

[0134] 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.

[0135] 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 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 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.

[0136] Another concept (called the "shish kebab" concept) allows multiple magnetic segments to be delivered through a single conduit that effectively punctures the target tissue and delivers the segments.

[0137] Figure 46 is a schematic diagram showing a plurality of magnetic segments 16a, 16b being transported through a single conduit according to one exemplary embodiment. This example shows two magnetic segments 16a and 16b being transported through a single conduit 14, such as a laparoscope or other transport device having an elongated body and a lumen extending through the body and being shaped and / or sized to receive and pass a plurality of magnetic segments. Generally, each of these magnetic segments 16a, 16b, upon transport, forms a magnetic compression anastomosis device 16 (sometimes simply referred to herein as a “magnet”) by self-assembly or other mechanisms described herein. Generally, different magnetic segments (e.g., magnetic compression anastomosis devices) are transported to different lumens, for example, to capture two separate lumens for anastomosis, as further described below, although technically, different magnetic segments may be transported to the same lumens. In some exemplary embodiments, the magnetic segments are separated by one or more separator segments 331, which may be magnetic or non-magnetic, for example, to facilitate the delivery of magnetic segment 16b while retaining magnetic segment 16a in the conduit for later delivery. While the “shish kebab” concept has been described here in the context of esophagojejunal anastomosis, it should be noted that this concept is not limited to any particular procedure or number of magnetic segments delivered. Therefore, for example, this concept could be used to deliver two, three, or more magnetic segments.

[0138] Figure 47 is a schematic diagram showing details of a separator segment 331 according to one exemplary embodiment. In particular, the separator segment 331 includes iron connectors 343 at each end to maintain the alignment of the magnetic compression anastomosis device segments 16a, 16b (magnets), a key or locking mechanism 342 to ensure control and recapture, and a centering mechanism for centering the suture 320 or wire line to maintain the centering of the magnet 16. The key or locking mechanism is shown in detail in Figure 56. When the magnet is deployed from the feeder, the key or locking mechanism is extended through the distal end of the feeder. The suture attached to the magnet is centered by the centering mechanism and controlled by the surgical handle shown in Figure 49. After the magnet has been deployed and self-assembled, the key is made capable of magnetically coupling to the magnet based on the iron connector. The connector engages with the magnet, allowing the key to manipulate the magnet to properly position it at the target site, as shown in Figures 57A–57J. When the distal and proximal magnets are paired, the magnetic force of the key is weaker than the attractive force between the magnets, allowing the key to be removed. The key is then retracted into the feeding device and removed from the patient.

[0139] Figure 48 is a schematic diagram showing how the separator segment shown in Figure 47 may be used to deploy and control the magnetic segments of two magnetic compression anastomosis devices (magnets) according to one exemplary embodiment. Here, separate suture / control lines A and B extend from the device handle through the centering mechanism of the separator segment to the two magnets. When the two magnets are deployed, the separate suture / control lines control the magnets via a surgical handle device as shown in Figure 49, attracting and bringing the magnets close together to magnetically couple them, which can then be used to capture two luminal tissues, for example, for anastomosis. Iron or magnetic members in the separator segment engage with the magnets and, additionally, control and position the magnetic device.

[0140] Figure 49 is a schematic diagram showing a laparoscopic handle having control means for simultaneously controlling multiple (e.g., two) independent lines. In this exemplary embodiment, the handle is attached to a laparoscope, but in other embodiments, the handle may be attached to an endoscope or other similar device. The exemplary embodiment provides the ability to independently pull and / or press each line, thereby achieving and maintaining the capture of a “cut” (hole) under laparoscopy. The handle may include a button for cutting the line and a button for capturing the line to maintain tension on the line, as shown in Figure 55.

[0141] Next, with reference to Figures 50A to 50E, an exemplary procedure using the “shish kebab” concept will be described. In Figure 50A, the shaft member, via a puncturing or cutting member, penetrates the target tissue from the patient’s body cavity towards the proximal lumen, forming a bowel incision. The shaft then proceeds through the tissue wall opposite the proximal lumen, as shown in Figure 50A, to form an exit incision, and then through the tissue wall of the distal lumen to form an entrance incision. The shaft member includes two linear self-forming compression members. In Figure 50B, a surgical handle device is used to advance the first self-forming compression member into the distal lumen. The first self-forming compression member is deployed and controlled by the handle device, as well as a pivotable tension member such as a suture and / or guidewire. The tension control member is attached to the compression anastomosis device and extends from the distal end through the shaft of the feeding device to the surgical handle at the proximal end. The tension control member is operated by the surgical handle device at the proximal end of the feeding device. In Figure 50C, the shaft member is pulled back into the proximal lumen through the inlet and outlet incisions, while the first self-forming compression magnet remains in the distal lumen. In Figure 50D, a surgical handle device is used to deliver the second self-forming compression member into the proximal lumen. The second self-forming compression member is deployed and controlled by the surgical handle device and basket control member at the distal end of the shaft. The basket engages with the proximal magnet, thereby aligning the proximal magnet with the distal magnet and bringing it to the target site in the tissue wall. Figure 50E schematically shows a surgical handle device prepared to connect the two deployed self-forming members by, for example, manipulating a tether or tension device between the two self-forming compression members to pull them closer to each other until the two self-forming compression members automatically and magnetically connect, thereby forming an anastomosis. Next, the tension control member is cut, releasing the anastomosis device that is to remain inside the patient, while the tension control member is retracted into the feeding device and removed from the patient. The exit and inlet incisions remain open, allowing fluid and other materials to pass through the resulting anastomosis.Next, the feeding device is retracted through the initial incision and then removed from the patient. The initial incision can be closed using sutures or the like.

[0142] The proximal anastomosis device may be deployed before the distal anastomosis device. Initially in the proximal lumen, the proximal anastomosis device can be deployed before the feeding device leaves the proximal lumen and enters the distal lumen. Once the proximal anastomosis device is deployed, the feeding device is advanced into the distal lumen, where the distal anastomosis device is deployed.

[0143] The following is an example of a “shish kebab” concept related to the implementation of a duodenal / ileal junction, according to one exemplary embodiment. First, the surgeon locates the region of the ileum to which the junction to the duodenum is desired, breaks the iliac crest down to the duodenal region within the foregut, and enters the ileum with the escorting device, for example using monopolar energy to cauterize the ileal tissue wall (e.g., Figure 50A). While inside the ileum, the surgeon selects the exit point of the ileum on the opposite ileal wall and punctures the ileal tissue wall, for example using monopolar energy to cauterize the ileal tissue wall (e.g., Figure 50A). Next, the surgeon selects a region to enter the duodenum and enters the duodenum by puncturing the duodenal tissue wall (e.g., Figure 50A). Once inside the duodenum, the surgeon deploys the first magnetic segment (e.g., Figure 50B). Next, the surgeon withdraws the feeding device into the ileum (e.g., Figure 50C), raises the ileum toward the duodenum, and deploys the second magnetic segment within the ileum (e.g., Figure 50D). Once both magnetic segments are deployed, the surgeon can position the two magnetic segments by pulling them together, for example, using one or more tethers (e.g., Figure 50E), or by aligning or self-aligning the two magnetic segments in another way to magnetically couple them, thereby capturing the two incisions. The feeding device can then be removed through the original incision in the ileum.

[0144] Accordingly, some exemplary embodiments include the ability to recapture a compression anastomosis device during deployment, including the ability to capture multiple orifices in the digestive system and / or control a self-assembling compression anastomosis device during laparoscopic or endoscopic delivery and deployment. A key or locking mechanism may be included to provide the ability to deploy or retract the magnetic segment at any time. The key or locking mechanism is fitted into the linear compression anastomosis device before self-assembly.

[0145] Additionally, in some exemplary embodiments, the surgical handle device may be delivered through a single conduit along with a plurality of self-forming compression members, the conduit effectively puncturing target tissue to deliver the self-forming compression members. The surgical handle device may have various members forming a control system connected to the self-forming compression members for deploying, controlling, and releasing the self-forming compression members. The surgical handle device may include an actuated tension member, thereby enabling continuous contact between two or more self-forming compression members. The surgical handle device can create alignment between two or more self-forming compression members.

[0146] Next, with reference to Figures 51A to 51F, another concept using two engageable feeders is described. In this exemplary embodiment, the feeder is a laparoscope. Figure 51A schematically shows a magnetare device with multiple magnetic compression anastomosis segments loaded into the distal lumen before the compression anastomosis device is deployed into the lumen. The feeder punctures from the body cavity toward the distal lumen by a puncturing member and / or cutting member at the distal end of the feeder and advances into the distal lumen. Figure 51B schematically shows the distal magnetare device and magnetic segments after the compression anastomosis device has been deployed and controlled in the distal lumen. The distal magnetic anastomosis device is deployed into the distal lumen by the magnetare device through the distal end of the feeder. By withdrawing the feeder, the magnetic anastomosis device is deployed into the distal lumen, while the magnetare remains located in the body cavity, although attached to the distal magnetic anastomosis device, as shown in Figure 51B. Figure 51C schematically shows a feeding device loaded into and deployed in the proximal lumen, the feeding device in this example including a capture mechanism for capturing a magnetic compression anastomosis device that has not yet been deployed. The distal end of the feeding device, removed from the distal lumen, punctures the proximal tissue wall of the proximal lumen and advances into the proximal lumen, where it deploys the capture mechanism. In some exemplary embodiments, this capture mechanism is designed to self-deploy (e.g., by applying a spring load) when extended beyond the distal opening of the feeding device and includes one or more magnets for capturing the compression anastomosis device, although other types of capture mechanisms (e.g., a mechanism for grasping and releasing the anastomosis device) may be used. Figure 51D schematically shows a magnetic compression anastomosis device deployed and captured by the capture mechanism of the feeding device in the proximal lumen. In this example, the magnetic compression anastomosis device may be deployed through a channel extending through the capture mechanism. As shown in Figure 51D, the proximal end of the magnetare device in the body cavity is operated using a second laparoscopic device. The distal end of the feeding device punctures the distal tissue wall of the proximal lumen, thereby forming a bowel incision. The magnetaire device is then manipulated by a second laparoscopy device into the bowel incision formed in the proximal lumen, where it engages with a capture device in the proximal lumen. Figure 51E schematically shows the magnetaire device captured by concentrically positioned capture devices.In other words, in this case, the magnetaire device is retracted into the feeding device, thereby bringing the two compression anastomosis devices together substantially concentrically. Figure 51F schematically shows the magnetaire device at least partially retracted into the feeding device, so that the two compression anastomosis devices are in close contact and magnetically coupled to each other, thereby capturing and compressing, for example, the walls of the distal lumen and the proximal lumen for anastomosis. Note that in some exemplary embodiments, the magnetaire device may be fed using a capture device and then recaptured by a capture device.

[0147] Figure 52 schematically shows the components of a disposable Magnetaire device according to one exemplary embodiment. In particular, this Magnetaire device includes (a) a magnetic compression anastomosis device, (b) one or more sutures, (c) one or more control members supporting the sutures, (d) a shaft member (which may be flexible or rigid), (e) a pulley mechanism member which is part of a suture control mechanism, and (f) a rotatable radial pulley moving member which can be used to extend or retract the suture and thus the magnetic compression anastomosis device.

[0148] Figure 53 schematically shows several magnetail configurations according to various exemplary embodiments. In particular, a magnetail may include (a) one or more sutures, (b) a balloon, (c) a deployable / retractable umbrella, (d) a cap, and / or (e) a basket for use in deploying and controlling a magnetic compression anastomosis device.

[0149] Therefore, some exemplary embodiments include a disposable magnetail assembly within a channel of a magnetic compression system device that includes a capture mechanism that is selectively operable in the axial and / or radial directions. Such a disposable magnetail typically allows for the control, deployment, and release of the magnetic compression anastomosis device, as well as the separation of the anastomosis device, while simultaneously maintaining the connection through the use of a single conduit. The disposable magnetail may be flexible to allow for easier handling. The magnetail may be configured to support various embodiments such as sutures, balloons, baskets, umbrellas, and / or caps, thereby providing a mechanical force to compress the tissue in addition to the magnetic energy resulting from the interaction between the two magnetic compression anastomosis devices. The magnetail may be fed by the capture mechanism, may be separable from the capture mechanism, and may be recaptureable by the capture mechanism.

[0150] Figure 54 schematically illustrates another concept (called a “hybrid” approach) that uses one endoscope and one laparoscope (unlike the two endoscopes). In this example, a first magnetic compression anastomosis in the distal lumen is captured by a magnetic capture device controlled via an endoscope in the proximal lumen. The first magnetic compression anastomosis device is brought into proximity to a second magnetic compression anastomosis device in the proximal lumen via a magnetic capture device using a laparoscope in the distal lumen for guidance and optionally for mechanical manipulation of the first magnetic compression anastomosis device. The first magnetic compression anastomosis device may be delivered via the endoscope or via another mechanism, for example, directly into the distal lumen.

[0151] Figure 55 schematically illustrates suture control handles for feeding devices such as endoscopes or laparoscopes according to various exemplary embodiments, the suture control handles being designed for one-handed suture operation. In particular, the suture control handle includes one or more suture wheels that enable the operation (e.g., tightening and / or loosening) of one or more sutures passing through the feeding device, one or more suture cutting buttons that control one or more suture cutting tools for cutting the sutures, and a capture / release and / or locking mechanism that can hold the sutures in place and maintain the tension applied to the sutures. In some embodiments, each suture is attached to a separate magnet, and each suture wheel operates on a separate magnet.

[0152] Figure 56 schematically shows an operating tool or “wand” that may be used to operate an anastomosis magnet (e.g., a magnetic compression anastomosis device) as described herein, in various exemplary embodiments. In particular, this operating tool includes a key for controlling the anastomosis magnet during feeding. The operating tool also includes a number of control magnets (two in this example, but alternative embodiments may include other numbers of control magnets) which can facilitate the capture, centering, and operation of the anastomosis magnet. The operating tool also includes a centering hole through which one or more centering sutures can be connected to the anastomosis magnet before feeding, thereby assisting in the centering and capture of the anastomosis magnet. The centering sutures may be connected to a suture control handle of the type described above with reference to Figure 55, which can be operated by using a suture wheel that “winds” the anastomosis magnet toward the operating tool until it is captured by the control magnets, and then a suture cutting button that cuts the centering sutures. The wand manipulating tool is extended from the feeder after the magnetic anastomosis device is deployed. The wand can be manipulated within the patient's body cavity and, using the iron component or magnet provided on the wand, engage with either the proximal or distal magnetic anastomosis device, bringing it closer to the other magnetic anastomosis device. The wand also has a key-shaped or hook-shaped distal end for manipulating the magnet during deployment. The centering suture can be operated by a suture control handle that "winds in" the distal anastomosis device, thereby bringing the distal anastomosis device into contact with the proximal anastomosis device. Once the magnets are paired, the wand can be removed based on the fact that the magnetic attraction of the wand is less than that of the anastomosis device. The wand is then retracted into the feeder and removed from the patient.

[0153] Next, with reference to Figures 57A to 57J, illustrative use of such operating tools will be described. Figure 57A is a photograph showing the distal end of the feeding device inserted into the first lumen. Figure 57B is a photograph showing the partial deployment of the first anastomosis magnet into the first lumen. Figure 57C is a photograph showing the first anastomosis device fully deployed into the first lumen. Figure 57D is a photograph showing the distal end of the feeding device inserted into the second lumen. The suture connects the first anastomosis device, which is connected to the feeding device, to the suture control handle. Figure 57E is a photograph showing the partial deployment of the second anastomosis magnet into the second lumen. Figure 57F is a photograph showing the second anastomosis device fully deployed into the second lumen. Figure 57G is a photograph showing the remote control of the second anastomosis magnet using a manipulating tool (for example, in this example, the second anastomosis device is moved relative to its position in Figure 57F by magnetic attraction between the second anastomosis device and the manipulating tool). The suture connects the first and second anastomosis devices to the feeding device and ultimately to the suture control handle. Figure 57H is a photograph showing the capture of the second anastomosis device by the manipulating tool from outside the second lumen, i.e., the second anastomosis device being captured through the wall of the second lumen and operable from outside the second lumen. The manipulating tool engages with the second anastomosis device via a magnet provided on the manipulating tool. Figure 57I is a photograph showing the operation of bringing the second anastomosis device closer to the first anastomosis device using the manipulating tool. Figure 57J is a photograph showing the connection of the first and second anastomosis devices using a manipulating tool that guides the connection. Although not shown in the diagram, the operating tool is disengaged from the magnetic anastomosis device based on the fact that the attractive force of the magnet or iron component on the operating tool is less than the attractive force between the magnetic anastomosis devices. The operating tool is then retracted into the feeding device and removed from the patient.

[0154] 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.

[0155] Equal parts 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.

[0156] 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.

[0157] 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:

[0158] P1. Capture and control of multiple orifices within the digestive system in laparoscopic feeding and compression anastomosis devices.

[0159] P2. Ability to recapture compression anastomosis devices during laparoscopic or endoscopic delivery and deployment.

[0160] P3. Key capability to ensure control during deployment of a self-assembling compression anastomosis device. Ability to incorporate into the implantation design in a linear position to allow the device to be deployed or retracted at any time. The illustrated design is an example of a “key” concept fitted into a linear compression anastomosis device before self-assembly.

[0161] P4. Multiple magnetic compression anastomosis devices delivered through a single conduit.

[0162] P5. Ability to grasp the incision site of the intestine.

[0163] P6. The ability to provide magnetic force in addition to magnetic energy.

[0164] P7. A surgical handle device equipped with multiple self-forming compression members, delivered via a single conduit that effectively punctures target tissue and delivers the self-forming compression members.

[0165] P8. The surgical handle device may have various components that form a control system connected to the self-forming compression member for deploying, controlling, and releasing the self-forming compression member.

[0166] P9. The surgical handle device may include an operable tension member, which allows for continuous contact between two or more self-forming compression members.

[0167] P10. A surgical handle device that causes alignment between two or more self-forming compression members.

Claims

1. A system for delivering a compression anastomosis device, the system is The feeding device includes a distal compression anastomosis device and a proximal compression anastomosis device separated by separator segments within a single conduit of the feeding device, The system further includes a pivotable tension member coupled to the distal compression anastomosis device, which passes through a centering mechanism for a separator segment within the single conduit.

2. The system according to claim 1, wherein the feeding device is a laparoscope.

3. The system according to claim 1, wherein the pivotable tension member includes a suture.

4. The system according to claim 1, wherein the separator segment is magnetic.

5. The system according to claim 1, wherein the separator segment is configured to maintain alignment between the distal compression anastomosis device and the proximal compression anastomosis device within the conduit of the feeding device.

6. The system according to claim 1, wherein the feeding device includes a control device for controlling the tension applied to the pivotable tension member.

7. The system according to claim 6, wherein the control device is a wheel.

8. The system according to claim 1, wherein the feeding device is an endoscope.

9. The system according to claim 1, wherein the pivotable tension member includes a wire.

10. The system according to claim 1, wherein the separator segment is nonmagnetic.

11. The system according to claim 1, wherein the separator segment includes a key or locking mechanism configured to control and / or recapture at least one of the compression anastomosis devices during or after feeding.

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