Systems, devices and methods for creating an anastomosis

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 / 191,146 (Attorney Docket No. 121326-11600), entitled SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES, filed May 20, 2021, which is incorporated 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 Ser. No. 17 / 108840, entitled SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES, filed on December 1, 2020 (Attorney Docket No. 121326-11101), which is a continuation-in-part of, and therefore claims priority to, International Patent Application No. PCT / US2019 / 035202, having an international filing date of June 3, 2019 (Attorney Docket No. 121326-11102). This international patent application, PCT Application No. PCT / US2019 / 035202, claims the benefit of and priority to U.S. Provisional Application No. 62 / 679,810, filed June 2, 2018, U.S. Provisional Application No. 62 / 798,809, filed January 30, 2019, and U.S. Provisional Application No. 62 / 809,354, filed February 22, 2019, the contents of each of which are incorporated by reference in their entirety.

[0003] Technical Field The present invention relates to deployable magnetic compression devices, and more particularly to systems, devices and methods for delivering, deploying and positioning magnetic compression devices at a desired site to thereby improve the accuracy of anastomosis formation between tissues, organs and the like.

[0004] Background technology Bypasses in the gastrointestinal (GI), cardiovascular or urinary systems are typically created by drilling holes in two tissues and connecting the holes with sutures or staples. The bypass is typically placed to route fluids (e.g., blood, nutrients) 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 adverse reactions to anesthesia. Additionally, bypasses created with sutures or staples can cause complications due to post-operative leaks and adhesions. Leaks can result in infection or sepsis, whereas adhesions can result in complications such as intestinal strangulation and ileus. Conventional bypass procedures can be completed using endoscopes, laparoscopes or robots, but can be time-consuming to connect the holes drilled in the tissue. Additionally, such procedures require special expertise and equipment that is not available in many surgical facilities.

[0005] Instead of sutures or staples, surgeons can use mechanical couplings or magnets to create a compression anastomosis between tissues. For example, a compression coupling or magnet pair can be delivered to the tissues to be connected. Due to the strong compression, the tissue trapped between the coupling or magnets is cut off from its blood supply. Under these circumstances, the tissue necrotizes and degenerates while new tissue grows around the compression point, e.g., at the edges of the coupling. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0006] Nevertheless, the locations where compression anastomoses can be used are limited because magnet or coupling placement is difficult. In most cases, magnets or couplings must be delivered as two separate assemblies, requiring either an open surgical field or bulky delivery devices. 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 anastomoses formed are small and suffer from short-term patency. Furthermore, magnet or coupling placement can be inaccurate, which can lead to anastomoses being formed in undesirable or incorrect locations.

[0007] Thus, a clinical need remains for reliable devices and minimally invasive procedures that facilitate the creation 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 creating anastomoses in the body that facilitate faster, less expensive treatments for chronic diseases such as obesity and diabetes, and that reduce the time and pain associated with palliative treatments for diseases such as cancer.

[0009] Various methods of the present invention may include a feeding device penetrating through a proximal tissue wall into the proximal lumen to form an intestinal incision. The feeding device may then be advanced through a distal tissue wall of the proximal lumen to form an exit incision. The feeding device may then be advanced through a tissue wall of the distal lumen to form an entry incision, thereby entering the distal lumen. The distal compression anastomosis device may then be deployed from the feeding device into the distal lumen. The feeding device may then be retracted from the distal lumen through the entry incision and into the proximal lumen through the exit incision. While in the proximal lumen, the proximal anastomosis device may be deployed from the feeding device into the proximal lumen. A control member may then be deployed through the feeding device into the proximal lumen. The control member may be utilized to manipulate the proximal compression anastomosis device to press the proximal anastomosis device against the tissue wall of the proximal lumen to a first target site and align the proximal anastomosis device with the distal anastomosis device. The pivotable tensioning member can then be tensioned to bring the distal anastomosis device against the tissue wall of the distal lumen to the second target site, thereby bringing the anastomosis devices together to form an anastomosis. The pivotable tensioning member can then be cut and retracted into the delivery device, thereby releasing the anastomosis device. The delivery device can then be retracted from the proximal lumen through the enterotomy and into the body cavity and removed from the patient.

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

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

[0012] In one embodiment, the proximal anastomotic device may be deployed before the distal anastomotic device.

[0013] Various methods of the present invention may include a feeder piercing a tissue wall of the distal lumen and advancing into the distal lumen to deploy a distal compression anastomosis device from a distal end of the feeder. A magnet tail device may then be deployed from the feeder, such that a distal end of the magnet tail is connected to the distal anastomosis device in the distal lumen and a proximal end of the magnet tail is within the body cavity outside of the distal lumen. The feeder may then be retracted from the distal lumen into the body cavity and then advanced into the proximal lumen to pierce a proximal tissue wall of the proximal lumen to deploy a proximal compression anastomosis device. The feeder may then pierce a distal tissue wall of the proximal lumen, thereby forming a distal enterotomy. A proximal end of the magnet tail device may be manipulated using a laparoscope and attached to the feeder through the distal enterotomy. The delivery device is then retracted, thereby bringing the distal magnetic anastomosis device into proximity with the proximal anastomosis device, thereby allowing an anastomosis to be formed 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 an apparatus for manipulating the placement of a compression anastomosis device, the apparatus including a magnetail device, a compression anastomosis device at a distal end of the magnetail, a pulley mechanism or shaft member attached to the sutures, and a pulley movement member at a proximal end attached to the pulley mechanism that has the ability to extend or retract the sutures to manipulate the compression anastomosis device.

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

[0017] In various embodiments, the present invention may include an apparatus for manipulating a suture and / or guide member within a patient, the apparatus 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 through its center, where a suture or guide wire extends through the conduit from the distal end to the proximal end. The handle may be fitted with one or more suture wheels capable of manipulating the tension applied to the suture. In some embodiments, the handle may be fitted with a suture cut button capable of cutting the suture. The handle may be fitted with a capture / release and / or locking mechanism capable of maintaining tension applied to the suture and holding the suture in place.

[0018] Some embodiments of the invention may include a device for placement and control of a compression anastomosis device, including a wand member that can be deployed from a delivery device. The distal end of the wand member may be keyed or hooked to be able to engage the compression anastomosis device. The wand member may have a conduit extending from the distal end to the proximal end, where one or more sutures extend through the conduit to be able to control the compression anastomosis device. The wand member may have one or more magnets on its front face proximal to the hook, the magnets being linearly disposed along the proximal axis to the distal axis, and able to engage the compression anastomosis device to manipulate placement of the device at a target site within the patient. The magnets may have a magnetic force less than that of the compression anastomosis device, thereby disengaging it from the compression anastomosis device. The wand member may be retracted into the delivery device and removed from the patient. [Brief description of the drawings]

[0019] Features and advantages of the claimed subject matter will become apparent from the following detailed description of the corresponding embodiments, which description should be discussed with reference to the accompanying drawings. [Figure 1] 1 is a schematic diagram of an anastomosis formation system consistent with the present disclosure. [Diagram 2] FIG. 1 shows several potential anatomical targets for anastomosis creation; arrow A, stomach to small intestine; arrow B, small intestine to large intestine; arrow C, small intestine to small intestine; arrow D, large intestine to large intestine; and arrow E, stomach to large intestine. [Diagram 3] FIG. 1 illustrates an exemplary magnetic anastomosis device being fed through an endoscopic instrument channel such that the individual magnet segments self-assemble to form a larger magnetic structure, in this particular case an octagon. [Figure 4A] FIG. 1 shows two magnetic anastomosis devices attracting each other through tissue. As shown, the devices each have eight magnetic segments, although alternative configurations are possible. When the two devices are joined, the tissue trapped between the devices will necrotize, causing the anastomosis to form. Alternatively, the tissue joined by the devices can be perforated after the devices are joined, thereby immediately forming the anastomosis. [Figure 4B] 1 illustrates two magnetic anastomosis devices that join together by magnetic attraction and capture intervening tissue, In some instances, an endoscope may be used to cut the surrounded tissue. [Figure 5A] FIG. 13 shows a needle delivering a first magnetic device to a target site within a first portion of a hollow body. [Figure 5B] A second magnetic device is then deployed within a second portion of the hollow body adjacent the target site. [Figure 6A] FIG. 13 illustrates delivery of a magnet assembly into the gallbladder by an ultrasound endoscopically guided needle. [Figure 6B] FIG. 13 shows a magnet assembly mating with a second magnet assembly in the stomach or duodenum. [Figure 7] FIG. 13 illustrates a single guide member for deploying and manipulating the magnetic anastomosis device. [Figure 8A] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8B] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8C] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8D] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8E] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8F] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 9] Figures 9, 10, 11 and 12 show various methods of accessing a target site, specifically, various methods of accessing the gallbladder using an ultrasound endoscopic guided procedure, with Figure 9 showing the use of monopolar energy to puncture and access the gallbladder. [Figure 10] FIG. 1 illustrates the use of a fine needle aspiration (FNA) to puncture and access the gallbladder. [Figure 11] FIG. 1 illustrates the use of a spiral needle to puncture and access the gallbladder. [Figure 12] FIG. 1 illustrates the use of a guidewire through the bile duct. [Figure 13] FIG. 13 illustrates an ultrasound endoscopically guided needle that punctures the gallbladder to access the interior of the gallbladder and then delivers a magnet assembly into the gallbladder. [Figure 14] 14, 15, 16 and 17 show various devices for securing the access device and / or delivery device to a target site in the gallbladder, with FIG. 14 showing a T-bar member. [Figure 15] FIG. 1 illustrates a Nitinol coil (eg, a "pigtail"). [Figure 16] FIG. 2 shows a balloon member of a catheter. [Figure 17] FIG. 1 shows a Malecot catheter. [Figure 18A] 1A-1D illustrate 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 18B]1A-1D illustrate 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] 1A-1D illustrate 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] 1A-1D illustrate 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] 1A-1D illustrate 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] 1A-1D illustrate 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] FIG. 18B illustrates a variation of the design of FIGS. 18A-18F, specifically utilizing a balloon to deliver a single magnetic anastomosis device into the gallbladder rather than delivering pairs. [Figure 20A] FIG. 13 illustrates a method of accessing the gallbladder through ultrasound endoscopic guided access using a high temperature insertion tube emitting monopolar energy, and then delivering a magnetic anastomosis device into the gallbladder through the high temperature tube. [Figure 20B] FIG. 13 illustrates a method of accessing the gallbladder through ultrasound endoscopic guided access using a high temperature insertion tube emitting monopolar energy, and then delivering a magnetic anastomosis device into the gallbladder through the high temperature tube. [Figure 20C] FIG. 13 illustrates a method of accessing the gallbladder through ultrasound endoscopic guided access using a high temperature insertion tube emitting monopolar energy, and then delivering a magnetic anastomosis device into the gallbladder through the high temperature tube. [Figure 21A] 1A-1C illustrate 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 21B]1A-1C illustrate 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 21C] 1A-1C illustrate 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 21D] 1A-1C illustrate 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 21E] 1A-1C illustrate 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 22A] FIG. 21A-21E show a variation of the procedure and device shown in FIG. 21A-21E, in which the magnetic anastomosis device is preloaded into the distal end of the Malecot catheter of the delivery device, so that the device is delivered and deployed when the Malecot end is transitioned to a fixed position. [Figure 22B] FIG. 21A-21E show a variation of the procedure and device shown in FIG. 21A-21E, in which the magnetic anastomosis device is preloaded into the distal end of the Malecot catheter of the delivery device, so that the device is delivered and deployed when the Malecot end is transitioned to a fixed position. [Figure 22C] FIG. 21A-21E show a variation of the procedure and device shown in FIG. 21A-21E, in which the magnetic anastomosis device is preloaded into the distal end of the Malecot catheter of the delivery device, so that the device is delivered and deployed when the Malecot end is transitioned to a fixed position. [Figure 23] FIG. 13 shows a Malecot catheter with its distal end expanding into a fixed position on one side of the gallbladder tissue wall. [Figure 24] FIG. 13 shows a Malecot catheter with its distal end expanding into fixed positions on either side of the gallbladder tissue wall. [Figure 25A] FIG. 1 illustrates 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., gastric or duodenal tissue). [Figure 25B]FIG. 1 illustrates 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., gastric or duodenal tissue). [Figure 25C] FIG. 1 illustrates 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., gastric or duodenal tissue). [Figure 25D] FIG. 1 illustrates 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., gastric or duodenal tissue). [Figure 25E] FIG. 1 illustrates 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., gastric or duodenal tissue). [Figure 26A] FIG. 25A-25E depict a variation of the procedure and devices shown in FIG. 25A-25E, in which the deployment sheath has a notch at its distal end that is configured to engage the T-bar as it advances through the intestinal incision, thereby pushing the T-bar laterally and then allowing delivery and deployment of the magnetic anastomosis device. [Figure 26B] FIG. 25A-25E depict a variation of the procedure and devices shown in FIG. 25A-25E, in which the deployment sheath has a notch at its distal end that is configured to engage the T-bar as it advances through the intestinal incision, thereby pushing the T-bar laterally and then allowing delivery and deployment of the magnetic anastomosis device. [Figure 26C] FIG. 25A-25E depict a variation of the procedure and devices shown in FIG. 25A-25E, in which the deployment sheath has a notch at its distal end that is configured to engage the T-bar as it advances through the intestinal incision, thereby pushing the T-bar laterally and then allowing delivery and deployment of the magnetic anastomosis device. [Figure 27A]FIG. 27A-27C illustrate another variation of the procedure and device shown in FIGS. 25A-25E. Rather than having a deployment sheath for delivering a self-assembling magnetic anastomosis device as previously described in this specification, the assembly shown in FIGS. 27A-27C relies on depositing T-bars through an access needle, whereby a group of T-bars are configured to self-assemble into an array and act as a distal anastomosis device to correspond and bind to a proximal magnetic anastomosis device located on the opposite side, and then compress the tissue therebetween to form an anastomosis. [Figure 27B] FIG. 27A-27C illustrate another variation of the procedure and device shown in FIGS. 25A-25E. Rather than having a deployment sheath for delivering a self-assembling magnetic anastomosis device as previously described in this specification, the assembly shown in FIGS. 27A-27C relies on depositing T-bars through an access needle, whereby a group of T-bars are configured to self-assemble into an array and act as a distal anastomosis device to correspond and bind to a proximal magnetic anastomosis device located on the opposite side, and then compress the tissue therebetween to form an anastomosis. [Figure 27C] FIG. 27A-27C illustrate another variation of the procedure and device shown in FIGS. 25A-25E. Rather than having a deployment sheath for delivering a self-assembling magnetic anastomosis device as previously described in this specification, the assembly shown in FIGS. 27A-27C relies on depositing T-bars through an access needle, whereby a group of T-bars are configured to self-assemble into an array and act as a distal anastomosis device to correspond and bind to a proximal magnetic anastomosis device located on the opposite side, and then compress the tissue therebetween to form an anastomosis. [Figure 28A] 13A-13C illustrate a method of accessing the gallbladder via an ultrasound endoscopically guided needle access means utilizing a side port deployment sheath for delivering and deploying a pair of magnetic anastomosis devices. [Figure 28B] 13A-13C illustrate a method of accessing the gallbladder via an ultrasound endoscopically guided needle access means utilizing a side port deployment sheath for delivering and deploying a pair of magnetic anastomosis devices. [Figure 28C] 13A-13C illustrate a method of accessing the gallbladder via an ultrasound endoscopically guided needle access means utilizing a side port deployment sheath for delivering and deploying a pair of magnetic anastomosis devices. [Figure 29A] 13A-13C show knotting members configured to anchor an already deployed and positioned magnetic anastomosis device to tissue at a target site and then sever guide members or sutures coupled thereto. [Figure 29B] 13A-13C show knotting members configured to anchor an already deployed and positioned magnetic anastomosis device to tissue at a target site and then sever guide members or sutures coupled thereto. [Figure 29C] 13A-13C show knotting members configured to anchor an already deployed and positioned magnetic anastomosis device to tissue at a target site and then sever guide members or sutures coupled thereto. [Figure 30A] 1A-1D illustrate 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] 1A-1D illustrate 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] 1A-1D illustrate 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] 1A-1D illustrate 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] FIG. 13 shows a set of magnetic segments prepackaged with unstable polarity and including multiple guide members, tethers or sutures that connect adjacent segments together and assist in self-assembly of the magnetic segments into a polygonal unfolded shape. [Figure 31B] FIG. 13 shows a set of magnetic segments prepackaged with unstable polarity and including multiple guide members, tethers or sutures that connect adjacent segments together and assist in self-assembly of the magnetic segments into a polygonal unfolded shape. [Figure 32A] FIG. 31C illustrates a method of accessing the gallbladder through ultrasound endoscopic guided access utilizing an access device having a conductor with a "hot" tip that emits monopolar energy, and then delivering the prepackaged magnetic segments shown in FIGS. 31A and 31B through a sheath into the gallbladder. [Figure 32B] FIG. 31C illustrates a method of accessing the gallbladder through ultrasound endoscopic guided access utilizing an access device having a conductor with a "hot" tip that emits monopolar energy, and then delivering the prepackaged magnetic segments shown in FIGS. 31A and 31B through a sheath into the gallbladder. [Figure 33A] 1 illustrates a method of accessing the gallbladder by ultrasound endoscopic guided access utilizing a needle to access the gallbladder, and then delivering a wound stack of magnetic segments configured such that a distal anastomosis device acts to correspond and couple with a contralaterally positioned proximal magnetic anastomosis device and then compress the tissue therebetween to form an anastomosis. [Figure 33B] 1 illustrates a method of accessing the gallbladder by ultrasound endoscopic guided access utilizing a needle to access the gallbladder, and then delivering a wound stack of magnetic segments configured such that a distal anastomosis device acts to correspond and couple with a contralaterally positioned proximal magnetic anastomosis device and then compress the tissue therebetween to form an anastomosis. [Figure 33C] 1 illustrates a method of accessing the gallbladder by ultrasound endoscopic guided access utilizing a needle to access the gallbladder, and then delivering a wound stack of magnetic segments configured such that a distal anastomosis device acts to correspond and couple with a contralaterally positioned proximal magnetic anastomosis device and then compress the tissue therebetween to form an anastomosis. [Figure 34A] 1A-1D illustrate 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]1A-1D illustrate 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. [Diagram 35] FIG. 1 illustrates a magnetic anastomosis device that includes a continuous guide member or suture coupled to multiple magnetic segments of the device via eyelets disposed on each of the multiple magnetic segments. [Diagram 36] 13A-13C show one embodiment of a suture cutting device in a deployment sheath of a delivery device or a secondary device for cutting sutures coupled to a magnetic anastomosis device. [Figure 37A] FIG. 13 is an enlarged side view showing an anvil / sharpen device and a sharp / sharpen device for severing sutures. [Figure 37B] FIG. 13 is an enlarged side view showing an anvil / sharpen device and a sharp / sharpen device for severing sutures. [Figure 38] FIG. 13 shows a snare device (secondary device) configured to be inserted over a guide member or suture coupled to the magnetic anastomosis device and configured to sever the suture or guide member once the magnetic anastomosis device is deployed and positioned at a target site. [Figure 39A] FIG. 1 shows a snare device including a resistive heating element for severing a guide element. [Figure 39B] FIG. 13 shows a snare device including a ring member having a cutting blade for severing a guide member. [Figure 39C] FIG. 13 shows a snare device including a ring member having a cutting blade for severing a guide member. [Figure 39D] 13A-13C show secondary devices configured to effect severing of sutures or guide members using monopolar / bipolar energy. [Diagram 40] FIG. 13 illustrates a separate guide member or suture. [Figure 41A] FIG. 1 illustrates a removable suture assembly. [Figure 41B] FIG. 1 illustrates a removable suture assembly. [Diagram 42]FIG. 13 is a perspective view of another embodiment of a magnetic assembly consistent with the present disclosure. [Figure 43A] 13A-13D illustrate advancing the distal tip of a delivery device through the tissue walls of each of the adjacent organs at the target site and then forming an anastomosis therebetween. [Figure 43B] FIG. 13 is an enlarged view of the distal end of the feeder, showing a slot extending generally through the side of the body of the feeder. [Figure 43C] FIG. 13 illustrates sending a first magnetic assembly into a first organ. [Fig. 43D] FIG. 13 shows the first magnetic assembly being deployed within the first organ while remaining retained within the slot of the delivery device. [Figure 43E] FIG. 13 illustrates the first magnetic assembly, fully deployed within the first organ, being pulled toward the wall of the first organ by retracting the delivery device in preparation for delivering and deploying the second magnetic assembly within the second organ. [Figure 43F] FIG. 13 illustrates sending a second magnetic assembly into a second organ. [Figure 43G] FIG. 13 is an enlarged view, partially in section, of the second magnetic assembly proceeding to a deployed state. [Fig. 43H] FIG. 2 illustrates a first and second magnetic assembly coupled to one another as a result of attractive magnetic forces between the first and second magnetic assemblies in a fully deployed state. [Figure 43I] FIG. 13 illustrates a distal end of a delivery device that is configured in two halves that can be separated to allow the delivery device to be removed from the target site while the pair of magnetic assemblies remain coupled to each other to form an anastomosis at the target site. [Figure 44A] 1A-1C are cross-sectional views showing various cross sections of magnet segments of a magnetic assembly within the working channel of a standard scope. [Figure 44B] 1A-1C are cross-sectional views showing various cross sections of magnet segments of a magnetic assembly within the working channel of a standard scope. [Figure 44C]1A-1C are cross-sectional views showing various cross sections of magnet segments of a magnetic assembly within the working channel of a standard scope. [Fig.44D] 1A-1C are cross-sectional views showing various cross sections of magnet segments of a magnetic assembly within the working channel of a standard scope. [Diagram 45] FIG. 13 shows a list of some exemplary working channel sizes that may be used / feasible for deploying a caged magnetic array to form an anastomosis. [Figure 46] FIG. 2 is a schematic diagram illustrating multiple magnetic segments routed through a single conduit according to an exemplary embodiment. [Figure 47] FIG. 2 is a schematic diagram showing details of a separator segment according to an exemplary embodiment. [Figure 48] FIG. 48 is a schematic diagram illustrating how the separator segment shown in FIG. 47 can be used to deploy and control the magnetic segments of two magnetic compression anastomosis devices (magnets) according to one exemplary embodiment. [Figure 49] FIG. 1 is a schematic diagram showing a laparoscopic handle having a control means for simultaneously controlling multiple (eg, two) independent lines. [Figure 50A] FIG. 1 shows a schematic diagram of one exemplary procedure using the "shish kebab" concept. [Figure 50B] FIG. 1 shows a schematic diagram of one exemplary procedure using the "shish kebab" concept. [Figure 50C] FIG. 1 shows a schematic diagram of one exemplary procedure using the "shish kebab" concept. [Figure 50D] FIG. 1 shows a schematic diagram of one exemplary procedure using the "shish kebab" concept. [Figure 50E] FIG. 1 shows a schematic diagram of one exemplary procedure using the "shish kebab" concept. [Figure 51A] FIG. 13 is a schematic diagram illustrating another concept using two engageable feeders (for convenience referred to herein as a "magnetail" and a "capture device") according to one exemplary embodiment. [Figure 51B]FIG. 13 is a schematic diagram illustrating another concept using two engageable feeders (for convenience referred to herein as a "magnetail" and a "capture device") according to one exemplary embodiment. [Figure 51C] FIG. 13 is a schematic diagram illustrating another concept using two engageable feeders (for convenience referred to herein as a "magnetail" and a "capture device") according to one exemplary embodiment. [Fig. 51D] FIG. 13 is a schematic diagram illustrating another concept using two engageable feeders (for convenience referred to herein as a "magnetail" and a "capture device") according to one exemplary embodiment. [Figure 51E] FIG. 13 is a schematic diagram illustrating another concept using two engageable feeders (for convenience referred to herein as a "magnetail" and a "capture device") according to one exemplary embodiment. [Fig. 51F] FIG. 13 is a schematic diagram illustrating another concept using two engageable feeders (for convenience referred to herein as a "magnetail" and a "capture device") according to one exemplary embodiment. [Figure 52] FIG. 2 illustrates a schematic diagram of components of a disposable magnetail according to one exemplary embodiment. [Diagram 53] 1A-1C are schematic diagrams illustrating multiple magnetail configurations, according to various exemplary embodiments. [Figure 54] FIG. 13 is a schematic diagram illustrating another concept of using one endoscope and one laparoscope (as opposed to two endoscopes) (called a "hybrid" approach), according to one exemplary embodiment. [Figure 55] FIG. 13 is a schematic diagram illustrating a surgical handle concept featuring a suture control button. [Figure 56] FIG. 13A is a schematic diagram illustrating a control key concept for operating the anastomosis device, according to one embodiment. [Figure 57A] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Figure 57B]FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Figure 57C] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Fig. 57D] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Figure 57E] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Fig. 57F] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Fig. 57G] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Fig. 57H] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Fig. 57I] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment. [Fig. 57J] FIG. 13 is a schematic diagram illustrating a control key concept for operating two magnetic anastomosis devices in two lumens, according to one embodiment.

[0020] For a complete understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in conjunction with the above-mentioned drawings. Although the present disclosure has been described in connection with exemplary embodiments, it is not intended that the disclosure be limited to the specific forms set forth herein. It is self-evident that various omissions and equivalent substitutions are anticipated where suggested or expedient by the circumstances.

[0021] Detailed Description Exemplary embodiments provide improved devices and techniques for minimally invasively creating anastomoses within the body, for example, the gastrointestinal tract. Such devices and techniques facilitate faster, less expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, such as gastric or colon cancer.

[0022] The system generally includes an access device configured to be disposed within a hollow body of a patient to assist in forming an anastomosis at a target site (desired anatomical location) within the hollow body for forming an anastomosis between a first portion of tissue of the hollow body and a second portion of tissue of the hollow body at a target site. The access device provides access to the first and second portions of tissue of the hollow body and is further configured to deliver and position first and second implantable magnetic anastomosis devices relative to the first and second portions of tissue or adjacent tissue to form an anastomosis between the tissues at the target site. The first and second implantable magnetic anastomosis devices are configured to magnetically attract each other through a predetermined tissue region of the combined thickness of the tissue walls at the target site and exert a compressive force on the predetermined region to form the anastomosis.

[0023] The systems, devices, and methods described herein include, but are not limited to, various access devices for accessing a hollow body of a patient, such as the gallbladder, fixing the access device in place, and then deploying one of a pair of magnetic anastomosis compression devices. The systems, devices, and methods described herein further include various delivery devices for delivering at least one of the pair of magnetic anastomosis compression devices to a target site, where in some examples, a delivery device consistent with the present disclosure may assist in deploying at least one of the pair of magnetic anastomosis compression devices and then fixing it to the target site and / or coupling the pair of magnetic anastomosis compression devices to one another. The systems, devices, and methods described herein include various embodiments of the magnetic anastomosis compression devices and various designs for transitioning from a compact delivery configuration to a larger deployed configuration, generally by a self-assembly design.

[0024] More specifically, the exemplary embodiments provide a system that includes a delivery device for introducing and delivering a pair of magnetic assemblies between adjacent organs via minimally invasive techniques to bridge the tissue walls of each organ, thereby forming a passageway (i.e., anastomosis) therebetween. The delivery device is particularly useful in delivering the pair of magnetic assemblies to a target site in the gastrointestinal tract when an obstruction occurs (due to disease or other health problem), thereby forming an anastomosis between the stomach wall and the gallbladder wall to provide proper drainage of the gallbladder.

[0025] Thus, the illustrative embodiments provide improved devices and techniques for minimally invasively creating anastomoses within the body, for example, the gastrointestinal tract. Such devices and techniques facilitate faster, less expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, such as gastric or colon cancer.

[0026] 1 is a schematic diagram of an anastomosis formation system 10 for providing improved placement of a magnetic anastomosis device at a desired site, thereby increasing the accuracy of anastomosis formation between tissues within a patient 12. The system 10 generally includes an access device 14, a delivery device 15,100, a magnetic anastomosis device 16,200, and an imaging modality 18.

[0027] The access device 14 may generally include a scope, including but not limited to an endoscope, laparoscope, catheter, trocar, or other delivery device. For most applications described herein, the access device 14 is an endoscope and includes a delivery needle configured to deliver the magnetic anastomosis device 16,200. Thus, the system 10 of the present disclosure relies on a single endoscope 14 to deliver the two magnetic devices 16,200. As described in more detail herein, the surgeon can advance the endoscope 14 within the hollow body of the patient 12 based on a visual representation of the location of the target site provided by the imaging modality, and position the endoscope 14 at the desired anatomical location for forming the anastomosis. For example, the imaging modality may include a display on which an image or other visual representation showing the target site is displayed to the surgeon when performing medical imaging procedures, including but not limited to ultrasound (US), wavelength detection, x-ray based imaging, illumination, computed tomography (CT), radiography, and fluoroscopy, or combinations thereof. The surgeon can then rely on such visual depiction as he advances the endoscope through the hollow body to position the access device 14 in a portion of tissue adjacent to another portion of tissue at the target site, thereby ensuring that placement of the magnetic device 16,200 is accurate.

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

[0029] In some embodiments, the self-assembling magnetic device 16 is used to create a bypass in the gastrointestinal tract. Such a bypass may be used to treat cancerous blockages, weight loss or obesity, or may also be used to treat diabetes and metabolic diseases (i.e., metabolic surgery). FIG. 2 illustrates various gastrointestinal anastomosis targets that may be addressed by certain exemplary embodiment devices, 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 creating anastomoses within the body, for example, the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, such as gastric or colon cancer.

[0030] For example, if the hollow body through which the access device 14 may pass is the intestine of the patient 12, the first portion may be a distal portion of the intestine and the second portion may be a proximal portion of the intestine. The intestine 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 diseased, 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 is noted that the system may be used to form an anastomosis between a first portion of a hollow body tissue at a target site and an adjacent second hollow body tissue (e.g., a portal between the stomach and gallbladder, between the duodenum and gallbladder, stomach to small intestine, small intestine to large intestine, stomach to large intestine, etc.).

[0031] In an endoscopic procedure, a single endoscope 14 may be used to deliver the self-assembling magnetic device. The deployment of the magnetic device 16 is shown diagrammatically in FIG. 3. As shown, an exemplary magnetic anastomosis device 16 is delivered through the endoscope 14, which causes the individual magnet segments to self-assemble and form a larger magnetic structure, in this particular case an octagon. When used with the techniques described herein, when the device is deployed as a completed assembly, the device 16 allows for delivery of larger magnetic structures through smaller delivery conduits than would otherwise be possible, for example, within a standard endoscope. Larger magnetic structures also allow for the formation of larger and more robust anastomoses, achieving greater surgical success. For example, in some cases, the resulting anastomoses may have a 1:1 aspect ratio relative 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 relative to the dimensions of the magnetic assembly). In particular, prior art systems and methods involving the use of magnets to form an anastomosis are generally limited based on 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. However, the magnetic assembly design of the exemplary embodiments overcomes such limitations. For example, the design of the magnetic assembly, and in particular the coupling of multiple magnetic segments together via an exoskeleton, allows for any number of segments to be included in a single assembly, resulting in a resulting anastomosis that is larger in size relative to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomosis may have an aspect ratio ranging from 2:1 to 10:1 or more. Such aspect ratios are described in more detail with respect to Figures 44A, 44B, 44C, and 44D.

[0032] Because the magnetic devices are radiopaque and echogenic, the device may be positioned using fluoroscopy, direct visualization (transillumination or tissue impaction), and ultrasound, e.g., endoscopic ultrasound. Device 16 may be decorated with radiopaque paint or other markers to aid in identifying the polarity of the device during placement.

[0033] The magnetic anastomosis device 16 generally includes a plurality of magnetic segments that can assume a delivery configuration and a deployed configuration. The delivery configuration is typically linear, allowing the device to be delivered to tissue through a laparoscopic "keyhole opening" incision or through a natural pathway, such as the esophagus, using an endoscope 14 or similar device. Additionally, the delivery configuration is typically somewhat flexible, allowing the device to be guided through various curvatures within the body. Once the device is delivered, it will automatically transform from the delivery configuration to the deployed configuration, thereby assuming the deployed configuration of the desired shape and size. The self-transformation from the delivery configuration to the deployed configuration is guided by a coupling structure that moves the magnetic segments as desired without intervention. Exemplary self-assembling, self-closing, self-opening, etc. magnetic anastomosis devices 16 are described in U.S. Pat. Nos. 8,870,898, 8,870,899, 9,763,664, and 10,182,821, the contents of each of which are incorporated herein by reference in their entirety.

[0034] As shown in FIG. 4A, the magnetic anastomosis procedure generally involves placing first and second magnetic structures 16a, 16b adjacent first and second portions 20, 24 of tissues 22, 26, respectively, thereby bringing the tissues 22, 26 together. When the two devices 16a, 16b are brought into proximity, the magnetic structures 16a, 16b combine to bring the tissues 22, 26 together. Over time, an anastomosis of the size and shape of the devices 16a, 16b will form and the devices will fall off the tissues. In particular, the tissues 22, 26 surrounded by the devices will be necrotized and decomposed, providing an opening between the tissues.

[0035] Alternatively, the coupled devices 16a and 16b create sufficient compressive force to stop blood flow in the tissue 22, 26 trapped between the devices, allowing the surgeon to create an anastomosis by making an incision in the tissue 22, 26 surrounded by the devices, as shown in FIG. 4B.

[0036] In yet another embodiment, as described in more detail herein and shown in Figures 43A-43I, the surgeon can first incise or puncture the tissue 22, 26 and then feed the magnetic device 16a, 200a into the hollow body portion 20, thereby placing the device 16a, 200a around the incision in the tissue 22. The surgeon can then place the device 16b, 200b in the hollow body portion 24, thereby placing the device 16b, 200b around the incision in the tissue 26, and then couple the devices 16a, 200a and 16b, 200b together, thereby surrounding the incision. As before, once the devices 16a, 16b (200a, 200b) are coupled together, blood flow to the incision is immediately blocked.

[0037] While the figures and structures of this disclosure relate primarily 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, the self-assembling magnets can reassemble into polygonal structures, such as circles, ellipses, squares, hexagons, octagons, decagons, or other geometric structures that form closed loops. The device may additionally include handles, suture loops, barbs, and prongs as needed to achieve desired performance and make feeding (and removal) easier. In yet another embodiment, a magnetic assembly, such as the magnetic assembly 200 shown in FIG. 42, may include a pair of magnetic segments generally aligned with one another (e.g., aligned in an end-to-end fashion) and coupled to one another via a flexible exoskeleton member. Such embodiments are described in more detail herein.

[0038] As described above, the self-assembling magnetic anastomosis devices may be delivered to a target site via an access device 14. For example, as shown in FIG. 5A, the access device 14 may include a delivery needle 28 (e.g., a puncture needle) that is used to deliver (by puncture) a first magnetic anastomosis device 16a into the lower small intestine, and then a second magnetic device 16b is deployed into the upper small intestine at a tissue location adjacent to the target site (shown in FIG. 5B). Note that delivery may be guided by fluoroscopy or endoscopic ultrasound. Following self-assembly, the small intestine magnetic devices 16a, 16b bind to each other (e.g., magnetically attract each other) through a predetermined tissue region of the total thickness of the tissue wall at the target site, exerting a compressive force in the predetermined region to form an anastomosis.

[0039] FIG. 6A shows an endoscopic ultrasound guided needle delivering a magnet assembly into the gallbladder 302, which then couples with a second magnet assembly in the stomach 300 or duodenum 301 as shown in FIG. 6B. Thus, the described procedures may be used in conjunction with procedures to remove or block bypassed tissue. For example, an endoscopic ultrasound (EUS) may be used to facilitate transgastric or transduodenal access guided into the gallbladder 302 for placement of a self-assembling magnetic anastomosis device 16. Once access to the gallbladder 302 is achieved, various strategies may 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 may be retrieved and fluids drained by endoscope. For example, an anastomosis may be formed between the gallbladder 302 and the stomach using the described methods. Once the gallbladder 302 is accessed in a transgastric or transduodenal manner, gallstones may be removed. Additionally, 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] FIG. 7 illustrates a single guide member 30 for deploying and manipulating the magnetic anastomosis device 16. For example, once the self-assembling magnetic device 16 has been delivered to tissue, it is beneficial to be able to manipulate the position of the device 16. 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 with a guide member 30 such as a suture or wire. As shown in FIG. 7 and FIGS. 8A-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 FIG. 7, the guide member 30 can be coupled to a single distal segment, which results in an attachment point that provides freedom of translational movement during self-assembly. The configuration shown in FIG. 7 is also notable in that it allows for a closure force to be applied to the most distal segment. That is, if one or more segments become entangled in tissue or are otherwise prevented from self-assembly, a proximal pulling force from the guide member 30 can assist the device 16 to complete self-assembly. Once self-assembly is complete, device 16 can be positioned by guide member 30 as described above so that it can be coupled with another device (not shown) to form an anastomosis. Although not shown in Figure 7, it is contemplated that additional structures, such as a solid pusher or guide tube, may be used to deploy device 16 at the desired location.

[0041] The guide member 30 may be fabricated from a variety of materials to achieve the desired mechanical properties and biocompatibility. The guide member 30 may be constructed from metals, such as wires, such as stainless steel wires or nickel alloy wires. The guide member may be constructed from natural fibers, such as cotton or animal products. The guide member may be constructed from polymers, such as biodegradable polymers, such as polymers that include repeating units of lactic acid, lactone, or glycolic acid, such as polylactic acid (PLA). The guide member may be constructed from high tensile strength polymers, such as Tyvek™ (high density polyethylene fiber) or Kevlar™ (para-aramid fiber). In one embodiment, the guide member 30 is constructed from a biodegradable suture, such as VICRYL™ (polyglactin 910) suture available from Ethicon Corp., Somerville, NJ.

[0042] In some embodiments, the magnetic anastomosis device 16 may include multiple guide members 30. Various attachment points may be used to control the position and deployment of the self-assembling magnetic anastomosis device 16, as shown, for example, in Figures 8A, 8B, 8C, 8D, 8E, and 8F. As shown, four guide members 30(1)-30(4) may be coupled to four separate segments of the device 16. Each guide member may include a distal end coupled to a respective portion of the anastomosis device and a proximal end, such that manipulation of the proximal end (i.e., increasing or decreasing tension) may manipulate the position and orientation of the anastomosis device after it self-assembles into a predetermined shape (i.e., a polygon). 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 segments (segments between the most distal end segment and the most proximal end segment), and guide member 30(4) is coupled to the most proximal end segment.

[0043] 9-12 illustrate various methods of accessing a target site, specifically, accessing the gallbladder 302 by an ultrasound-guided procedure. FIG. 9 illustrates the use of monopolar energy to puncture and access the gallbladder 302. An endoscopic ultrasound scope (EUS scope) 303 accesses the stomach 300 / duodenum 301. A hot probe or guidewire 304 utilizing monopolar or bipolar energy punctures the tissue of the stomach 300 / duodenum 301 and gallbladder 302 for delivery of the anastomosis device 16.

[0044] 10 illustrates the use of a fine needle (FNA) to puncture and access the gallbladder 302. The FNA accesses the stomach 300 / duodenum 301 and a hypotube with a cutting blade 305 punctures the tissue of the stomach 300 / duodenum 301 and the gallbladder 302, thereby delivering the anastomosis device 16.

[0045] 11 illustrates the use of a spiral needle 306 to puncture and access the gallbladder 302. An 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 delivering the anastomosis device 16.

[0046] 12 illustrates 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 for delivery of the anastomosis device 16 into the gallbladder 302.

[0047] FIG. 13 shows an ultrasound endoscopically guided needle 303 puncturing the gallbladder 302 to access the interior of the gallbladder 302 and then delivering the magnet assembly 16 into the gallbladder 302.

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

[0049] FIG. 14 shows a T-bar member 310 tethered to the delivery device by a tether 311 which acts as a fixation device to hold the tissues 22, 26 together.

[0050] FIG. 15 shows a nitinol coil 312 (eg, a “pigtail”) that acts as a fixation device to hold the tissues 22, 26 together.

[0051] FIG. 16 shows a balloon member 313 of the catheter that acts as a fixation device to hold the tissues 22, 26 together.

[0052] FIG. 17 shows a Malecot catheter 314 that acts as a fixation device to hold the tissues 22, 26 together.

[0053] 18A-18F show a method of accessing the gallbladder 302 via an ultrasound endoscopically guided access means 303 and utilizing an access device emitting monopolar energy, anchoring a delivery device 15 using a balloon catheter 313, and then delivering a pair of magnetic anastomosis devices 16a, 16b within the balloon 313 while anchoring the balloon 313 within an intestinal incision made between tissue of the gallbladder 302 and an adjacent tissue (i.e., tissue of the stomach 300 or duodenum 301), thereby deploying devices 16a, 16b on either side of each tissue (i.e., a first device 16a within the gallbladder 302 and a second device 16b within the stomach 300 or duodenum 301) to form an anastomosis therebetween.

[0054] FIG. 18A shows an EUS scope 303 accessing the stomach 300 / duodenum 301 and a monopolar energy tip 304 piercing the tissue 26 of the stomach 300 / duodenum 301 towards the tissue 22 of the gallbladder 302 to deliver an anastomosis device into the tissue 22 of the gallbladder 302.

[0055] 18B shows a cutaway view of the delivery device 15. The monopolar energy tip 304 pierces the stomach 300 / duodenum 301 tissue 26 towards the gallbladder 302 tissue 22. The device 15 is positioned in the intestinal incision between the tissues. Within the delivery device 15, the magnetic anastomosis devices 16a, 16b are folded within a balloon catheter 313 within a sheath 315 within the delivery device 15. The conductor 316 is utilized to later remove the sheath 315 and stabilize the balloon catheter 313 in place.

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

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

[0058] 18E shows a cross section of a fully inflated balloon catheter 313. The "donut" shaped balloon has a narrow lumen or inner channel 318 to allow fluid or other materials to flow through the anastomosis.

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

[0060] FIG. 19 illustrates one variation of the design shown in FIGS. 18A-18F, specifically utilizing a balloon 313 to deliver a single magnetic anastomosis device 16 into the gallbladder 302 rather than delivering a pair.

[0061] 20A-20C show a method of using a high temperature insertion tube 304 emitting monopolar energy to access the gallbladder 302 with an ultrasound endoscopic guided access means 303 and then delivering a magnetic anastomosis device 16 into the gallbladder 302 via the high temperature tube 304. As shown in FIG 20B, the user only needs to activate the monopolar energy to advance the insertion tube 304 into the gallbladder 302.

[0062] FIG. 20A shows an EUS scope 303 utilizing a high temperature insertion tube 304 to access the stomach 300 / duodenum 301 and to access the gallbladder 302 for delivery of an anastomosis device 16 into the gallbladder 302.

[0063] FIG. 20B illustrates the operation of the monopolar energy tip 319 advancing the insertion tube 304 to access the gallbladder 302.

[0064] FIG. 20C shows the distal tip of the delivery device 15 deploying the magnetic anastomosis device 16a.

[0065] 21A-21E show a method of accessing the gallbladder 302 via an ultrasound endoscopically guided access means 303 and utilizing an access device 14 having a conductor 316 including a "hot" tip 304 emitting monopolar energy, securing the delivery device using a Malecot catheter 314, and then securing the Malecot catheter 314 within an enterotomy made between the gallbladder tissue 22 and adjacent tissue 26 (i.e., stomach or duodenal tissue) while utilizing the Malecot catheter 314 as a conduit for delivering the magnetic anastomosis device 16a through the Malecot catheter 314 into the gallbladder 302.

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

[0067] 21B illustrates a method of accessing the gallbladder 302 via an EUS-guided access means 303 and utilizing an access device 14 having a conductor 316 including a "hot" tip 304 emitting monopolar energy, anchoring the delivery device 15 using a Malecot catheter 314, and then anchoring the Malecot catheter 314 within an enterotomy made between the gallbladder tissue 22 and adjacent tissue 26 (i.e., tissue of the stomach 300 or duodenum 301) while utilizing the Malecot catheter 314 as a conduit for delivering the magnetic anastomosis device 16a through the Malecot catheter 314 into the gallbladder 302. The user pulls back the access device 14 to open the magnets 16a, 16b (FIG. 21C) and advances the tip 304 (FIG. 21D).

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

[0069] Figures 22A-22C show one variation of the procedure and device shown in Figures 21A-21E in which the magnetic anastomosis device 16a is preloaded into the distal end of the malecot catheter 314 of the delivery device 15 so that the device 16a is delivered and deployed when the end of the malecot 314 is transitioned to a fixed position.

[0070] FIG. 22A shows a magnetic anastomosis device 16 a preloaded within the distal end of the Malecot catheter 314 of the delivery device 15 with sutures 320 securing the magnet 16 a within the delivery device 15 .

[0071] FIG. 22B illustrates how the user pulls back on the suture 320 as the end of the malecot 314 transitions to a fixed position, resulting in delivery and deployment of the device 16a.

[0072] FIG. 22C shows how the delivery device 15 is pushed forward, severing the suture 320 within the fenestrations of the Malecot catheter 314.

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

[0074] 24 shows a malecot catheter 314 with its distal end extending into a fixed position on either side of the gallbladder tissue wall 22. In either instance, a temporary malecot 314 can be placed inside the gallbladder 302 to form a temporary conduit, allowing drainage to occur immediately and also allowing venting of the gallbladder 302. It should be noted that any of the embodiments (malecot 314, high temperature tube 305, nitinol coil 312, balloon 313, etc.) that provide access from the gastrointestinal tract into the gallbladder 302 can act as a drainage channel, specifically any device that forms a channel through which the magnetic anastomosis device 16 passes. More specifically, any material fluid within the gallbladder 302 can be drained (by itself or when suction is applied) after the access channel is formed and before delivery of the magnetic anastomosis device 16 begins. The channels may also be used to push fluid into the gallbladder 302 prior to draining the gallbladder (potentially through multiple fill / drain cycles), thereby allowing the gallbladder 302 to be "cleansed" if it has too much fluid and contents (i.e., bile or other contents) inside.

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

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

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

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

[0079] 26A-26C show a variation of the procedure and device shown in FIGS. 25A-25E where the deployment sheath 315 has a notch 322 at its distal end that is configured to engage the T-bar 310 as it advances through the intestinal incision, thereby pushing the T-bar 310 laterally and then allowing delivery and deployment of the magnetic anastomosis device 16.

[0080] FIG. 26A shows that the deployment sheath 315 has a notch 322 at its distal end that is configured to engage the T-bar 310 as it is advanced through the enterotomy.

[0081] FIG. 26B shows a notch 322 in the deployment sheath 315 that biases the T-bar 310 laterally, thereby allowing for subsequent delivery and deployment of the magnetic anastomosis device 16.

[0082] FIG. 26C shows the magnetic anastomosis device 16 deployed with the T-bars 310 pressed to the side.

[0083] 27A-27C show another variation of the procedure and device shown in FIGS. 25A-25E, in which rather than having a deployment sheath 315 for delivering a self-assembling magnetic anastomosis device 16 as previously described herein, the assembly shown in FIGS. 27A-27C relies on depositing T-bars 310 through an access needle 309, whereby a group of T-bars 310 self-assemble into an array and are configured as a distal anastomosis device 16a to couple with a corresponding contralaterally disposed proximal magnetic anastomosis device 16b, which then acts to compress the tissues 22, 26 therebetween to form an anastomosis.

[0084] 27A shows the assembly of a T-bar 310 being fed through an access needle 309. In some embodiments, the T-bar 310 is magnetic. By pulling back on the feeding device 14, the user can deploy the T-bar 310 into the lumen. The T-bar 310 is secured in place by sutures 320.

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

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

[0087] 28A-28C illustrate a method of accessing the gallbladder 302 via an ultrasound-guided access needle access means 303 utilizing a side port deployment sheath 315 for delivering and deploying a pair of magnetic anastomosis devices 16a, 16b.

[0088] 28A shows a method of accessing the gallbladder 302 for deployment of the distal magnetic anastomosis device 16a. The delivery device 15 accesses the stomach 300 / duodenum 301 and punctures the stomach tissue wall 26 towards the gallbladder 302. The delivery device 15 has a side port 322 for deployment of the proximal magnetic anastomosis device 16b.

[0089] FIG. 28B shows a rotating ring 323 with a metal insert 324, consistent with some embodiments of the present invention. The rotating ring 323 can rotate around 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 on the rotating ring 323 captures the magnetic devices 16a, 16b and guides the magnets 16a, 16b out of the feeder 15 and around the shaft of the feeder 15, thereby assisting in the self-assembly of the magnetic anastomosis devices 16a, 16b. The rotating ring 323 in some embodiments can be free to rotate or can rotate when the magnets 16 are pushed out of the feeder 15. In some embodiments, the rotating ring 323 can be actively rotated to withdraw the magnetic devices 16 from the feeder 15.

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

[0091] 29A-29C show knotting member 325 configured to secure already deployed and positioned magnetic anastomosis devices 16a, 16b to tissue 22, 26 at the target site and then sever guide members or sutures 320 coupled thereto. As shown in FIG. 29A, knotting member 325 is advanced over guide member 320 within the working channel of scope 14. Guide member 320 is positioned through patient 12 into stomach 300 and connected to gallbladder 302 and anastomosis devices 16a, 16b previously positioned within stomach 300.

[0092] As shown in FIG. 29B, the knotting member 325 advances towards the magnetic anastomosis device 16a, 16b, where the knotting member 325 generally comprises an outer tubular member 326 and an inner rod member 327, such that upon reaching the device 16a, 16b, the inner rod member 327 is pushed towards the distal end of the outer tubular member 326, thereby securing a portion of the guide member 320 between the outer tubular member 326 and the inner rod member 327, and further cutting the guide member 320 in the process.

[0093] FIG. 29C shows knotting member 325 advanced fully into magnetic anastomosis devices 16a, 16b, thereby anchoring guide member 320 and further severing guide member 320. FIG.

[0094] 30A-30D illustrate a method of accessing the gallbladder 302 with an ultrasound endoscopically guided access needle access means 303 and delivering a magnetic coil 328 or ring configured to transition from a substantially linear to a substantially circular shape when delivered into the gallbladder 302, and configured such that the distal anastomosis device corresponds and couples with an opposingly disposed proximal magnetic anastomosis device 16b and then acts to compress the tissue 22, 26 therebetween to form an anastomosis.

[0095] FIG. 30A shows a delivery device 15 accessing the stomach 10 and deploying a magnetic coil 328 or ring through the stomach tissue wall 26 into the gallbladder 302 to act as a distal anastomosis device.

[0096] 30B shows a close-up view of the magnetic coil 328 or ring in annular and straight positions. The magnetic device 328 is loaded into the delivery device 15 in a straight position. Once deployed, the magnetic device 328 self-assembles into a coil or ring shape, thereby acting as a distal magnetic anastomosis device. In some embodiments, the coil 328 is a laser cut hypotube that allows the magnetic device 328 to flex.

[0097] 30C shows a hypotube magnetic device 328 deployed within the distal lumen 329 by a nitinol wire or pigtail wire 312. The nitinol wire 312 pierces through the stomach tissue wall 26 toward the gallbladder 302, thereby delivering the distal anastomosis device, in this embodiment a magnetic hypotube 328.

[0098] Figure 30D shows the proximal magnet 16b coupled to a magnetic hypotube 328. Once deployed, 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, 328 combine to compress the tissue 22, 26 therebetween, thereby forming an anastomosis.

[0099] 31A and 31B show a set 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 one another and assist in self-assembly of the magnetic segments into a polygonal, unfolded shape.

[0100] FIG. 31A shows a set of magnetic segments 202, 204 prepackaged with unstable polarity and including multiple guide members 30, tethers or sutures 320 that connect adjacent segments 202, 204 to each other and assist in self-assembly of the magnetic segments 202, 204 into a polygonal expanded shape.

[0101] 31B shows the self-assembled magnetic anastomosis device 16. When deployed from the delivery device 15, the magnetic anastomosis device 16 self-assembles into a polygonal shape. The magnetic segments 202, 204 are supported in the polygonal deployed shape by the guide members 30.

[0102] 32A and 32B show a method of accessing the gallbladder 302 with an ultrasound endoscopically guided access means 303 using an access device 15 having a conductor including a "hot" tip 304 that emits monopolar energy, and then delivering the pre-packaged magnetic segments 202, 204 shown in FIGS. 31A-31B into the gallbladder 302 through a sheath 315.

[0103] 32A shows an EUS scope 303 being guided into the stomach 300. The scope 303 deploys a "hot" tip 304 that utilizes monopolar energy to penetrate the tissue 26 of the stomach 300 and puncture through a sheath 315 towards the gallbladder 302.

[0104] 32B shows a close-up of the deployment mechanism of the "hot" tip 304. The "hot" tip 304 utilizes monopolar energy to puncture the stomach tissue 26 towards the gallbladder 302. The distal magnet 16a, spacer 331 and proximal magnet 16b are loaded into the sheath 315. The user pulls back on the delivery device 15, causing the distal magnet 16a to deploy and self-assemble within the distal lumen 329.

[0105] 33A-33C illustrate a method of accessing the gallbladder 302 with an ultrasound-guided access means 303 utilizing a needle 309 to access the gallbladder 302, and then delivering a wound stack of magnetic segments 328 configured such that the distal anastomosis device corresponds to and engages with the contralaterally disposed proximal magnetic anastomosis device 16b, and then acts to compress the tissue therebetween to form an anastomosis. As shown in FIG. 33A, a 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 FIG. 33B. Pulling the suture 320 causes the magnetic segments 328 to fold on top of each other (based on magnetic attraction) as shown in FIG. 33C, and the wound stack of magnets is formed upon removal of the nitinol coil.

[0106] 34A-34B show a method of accessing the gallbladder 302 by an ultrasound endoscopic guided access means 303 utilizing a needle 309 to access the gallbladder 302, and then delivering into the gallbladder 302 a magnetic fluid 332 or suspension of magnetic particles configured as a distal anastomosis device to correspond and couple to a proximal magnetic anastomosis device 16b disposed on the opposite side, and then act to compress the tissues 22, 26 therebetween to form an anastomosis.

[0107] 34A shows an EUS scope 303 accessing the stomach 300. An access needle 309 with puncture capability punctures the stomach tissue 26 towards the gallbladder 302 and delivers magnetic fluid or magnetic particles 332 into the gallbladder 302.

[0108] FIG. 34B shows that upon approaching the proximal magnet 16b, the magnetic particles 332 are attracted to the proximal magnet 16b, compressing the tissues 22, 26 therebetween to form an anastomosis.

[0109] FIG. 35 illustrates a magnetic anastomosis device 16 including a continuous guide member 30 or suture 320 coupled to a plurality of magnetic segments 202, 204 of the device via eyelets 333 disposed on each of the plurality of magnetic segments 202, 204. The magnets 16 have eyelets 333 on an inner circumferential surface to prevent the suture 320 from becoming trapped or pinched between the magnets 16. The suture 320 extends through the eyelets 333 and has a plurality of legs 334(1)-(3) that can be pulled individually or simultaneously by a user to manipulate the magnets 16. To remove the suture 320, legs 334(1) and 334(3) may be pulled individually.

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

[0111] 37A and 37B are enlarged side views showing the anvil 335 / sharps 336 and sharps 336 / sharps 336 devices for severing the suture 320. FIG.

[0112] 37A shows a deployment sheath 315 that utilizes a push / pull guillotine method of mating anvil 335 / sharp 336 systems to sever suture 320. Pressing on the deployment sheath 315 exposes the blades, and pulling on the suture 320 introduces tension into the suture 320. The tensioned suture 320 is then pulled past the sharp cutting edge 336 and severed.

[0113] 37B shows a sharp 336 / sharp 336 system where the blade is exposed by pressing on the deployment sheath 315 and tension is introduced by pulling on the suture 320. The tensioned suture 320 is then pulled past the sharp cutting edge 336 and severed.

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

[0115] 39A shows a snare device that includes a resistive heating element for severing the guide member. The snare device 337 is guided through the support tube of the access device 14. Once the snare device 337 is in place over the suture 320, the snare device 337 is pulled back and energy is applied, thereby severing the suture 320. The applied energy may be low voltage from a battery or generator.

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

[0117] 39B shows a snare device 337 positioned outside of the scope 14, but which may be incorporated into the scope cap, within a snare sleeve 338 advanced into the stomach 300. By pulling back on 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] 39C shows a cross-sectional view of a snare device 337 including a ring member 339 having a cutting edge for severing the suture 320. By pulling back on the snare sleeve 338, the ring 339 with the cutting edge severs the suture 320.

[0119] 39D illustrates a secondary device configured to use monopolar / bipolar energy to effect severing of the suture 320 or guide member 30. The monopolar tip 304 is advanced towards the tissue 26 to sever the suture 320 attached to the deployed magnetic anastomosis device 16.

[0120] 40 illustrates a detachable guide member 30 or suture 320. In one exemplary embodiment, the suture has a reduced diameter or weakened region 340. Pulling back on the suture 320 will cause the suture 320 to detach from the deployed anastomosis device 16.

[0121] Figures 41A and 41B show a removable suture assembly. Within the sheath 315 are constraining overmolded drivers 341 attached to the sutures 320. The drivers 341 may be staggered to fit within the sheath 315 as shown in Figure 41A or may be in individual lumens. By removing the sheath 315, the overmolded drivers 341 are no longer constrained and are pulled apart as shown in Figure 41B.

[0122] Thus, the exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomoses within the body, for example, the gastrointestinal tract. Such devices and techniques facilitate faster, less expensive treatments for chronic diseases, such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases, such as cancer, such as gastric or colon cancer. More specifically, the exemplary embodiments provide various 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.

[0123] FIG. 42 shows a perspective view of another embodiment of a magnetic assembly 200 consistent with the present disclosure. The magnetic assembly 200 includes a pair of magnetic segments 202, 204 generally aligned with one another (e.g., aligned in an end-to-end fashion) and coupled to one another via a flexible exoskeleton member 206. The segments 202, 204 are spaced apart 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 placement device that aids in delivery of the magnetic assembly 200, as described in more detail herein. The exoskeleton may be fabricated from a resilient material that retains its shape after deformation, such as a polymer or a metal alloy. In some embodiments, the metal alloy will include nickel, such as Nitinol. Exemplary exoskeleton embodiments are described in U.S. Pat. Nos. 8,870,898, 8,870,899, and 9,763,664, the contents of each of which are incorporated herein by reference in their entirety.

[0124] The magnetic assembly 200 is configured to be delivered and deployed at a target site via the delivery device 100. As discussed above, the exemplary embodiments provide improved devices and techniques for minimally invasively forming an anastomosis within the body, for example, in the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, such as gastric or colon cancer. More specifically, the exemplary embodiments provide a system including the delivery device 100 for minimally invasively introducing and delivering a pair of magnetic assemblies between adjacent organs to bridge the tissue walls of the organs, thereby forming a passageway (i.e., anastomosis) therebetween. The delivery device 100 is particularly useful in delivering the pair of magnetic assemblies to a target site in the gastrointestinal tract when an obstruction occurs (due to disease or other health problem), thereby forming an anastomosis between the stomach wall and the gallbladder wall to provide for proper drainage of the gallbladder.

[0125] 43A-I illustrate various steps in deploying the pair of magnetic assemblies 200a, 200b at a target site and then 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 delivery device is advanced to the target site for delivering and positioning the pair of magnetic assemblies 200a, 200b, and then forming an anastomosis at the target site. In particular, the delivery device 100 includes an elongated hollow body 102, such as a catheter, shaped and / or sized to fit within the scope. The delivery device includes a working channel within which the pair of magnetic assemblies 200a, 200b are loaded. The delivery device further includes a distal end 104 configured to pierce or otherwise penetrate tissue.

[0126] For example, FIG. 43A illustrates advancing the distal tip of the feeder 100 through the tissue walls of each of the adjacent organs at the target site and then forming an anastomosis therebetween. For example, the distal end 104 may have a sharp tip for piercing the tissue and / or may utilize energy (i.e., a hot tip) to penetrate through the tissue. The body 102 of the feeder 100 further includes a slot or opening 106 adjacent the distal end 104 as shown in FIG. 43B. As shown, the slot extends generally through the side of the body 102 of the feeder 100. The slot 106 is shaped and / or dimensioned to receive the magnetic assemblies 200a, 200b therethrough such that the magnetic assemblies 200a, 200b pass through the working channel and exit the feeder 100 via the slot 106. The delivery device 100 further includes a retention member 108, generally in the form of a wire or the like, that is releasably coupled to one or both of the magnetic assemblies 200a, 200b and that provides a means for deploying the magnetic assemblies 200a, 200b from the distal end of the delivery device 100 through the slot 106.

[0127] During a procedure, a surgeon or other skilled medical professional may advance a scope (e.g., endoscope) into the hollow body of a patient and position the scope at a desired anatomical location to create an anastomosis based on any visual depiction of the location of the target site provided by an imaging modality providing 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 may advance the distal tip 104 of the delivery device 100 through 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 manner as described hereinabove. Upon advancing the distal end 104 including the slot 106 into the first organ (i.e., the common bile duct), the surgeon may utilize the retention member 108 to manually deliver and deploy the first magnetic assembly 200a through the slot into the first organ. For example, FIG. 43C illustrates delivery of the first magnetic assembly 200a into the common bile duct. As shown, the retention member 108 includes a connecting member 110 at a distal end of the retention member 108, which is configured to be removably coupled to a corresponding connecting member of the central portion 208 of the exoskeleton 206 (indicated by the attachment point arrows). Advancement and expansion of the retention member 108 toward the distal end 104 of the feeding device 100 causes the first magnetic assembly to move from the working channel of the feeding device 100 through the slot 106 to a deployed state, as shown in FIG. 43D. As shown, deployment of the first magnetic assembly 200a results in the pair of magnetic segments 202, 204 exiting the slot 106 on opposite sides of the body 102 of the feeding device 100, while the central portion 208 of the exoskeleton 206 remains within the slot 106. In other words, the slot 106 extends generally through the body 102 of the feeding device 100 from one side to the other. Thus, when in the deployed state, the first magnetic assembly 200a remains retained within the slot 106 of the delivery device 100 while being positioned within the first organ.

[0128] At this point, the surgeon need only retract the feeder 100 until the first magnetic assembly 200a engages the tissue of the first organ and the majority of the slot 106 is positioned within the second organ. The surgeon can then deliver and deploy the second magnetic assembly 200b into the second organ (i.e., the duodenum). Figure 43E shows that the first magnetic assembly 200a is fully deployed within the first organ, and retracting the feeder 100 draws the first magnetic assembly 200a against the wall of the common bile duct in preparation for delivery and deployment of the second magnetic assembly 200b into the duodenum.

[0129] The second magnetic assembly 200b deploys in a similar manner to the first magnetic assembly 200a, i.e., the magnetic segments 202, 204 of the second magnetic assembly 200b also exit the slot 106 on opposite sides of the body 102 of the delivery device 100, while the central portion 208 of the exoskeleton 206 remains retained within the slot 106. FIG. 43F illustrates delivery of the second magnetic assembly 200b into the duodenum. FIG. 43G illustrates a close-up view, partially in cross section, of the second magnetic assembly 200b moving toward a deployed state. As shown, the second magnetic assembly 200b is advanced through the working channel toward the slot 106, so that the assembly 200b is configured to engage the ramp 112 of the retention member, which assists in guiding at least one of the segments of the assembly 200b into position, as shown. FIG. 43H illustrates the first magnetic assembly 200a and the second magnetic assembly 200b in a fully deployed 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 couple with each other.

[0130] As shown in FIG. 43I, the distal end 104 of the delivery device 100 is composed of two halves that form a relatively uniform tip shape when in a default state. However, the distal end includes a deformable material (i.e., a shape memory material) that causes the two halves to separate when sufficient force is applied. In this manner, once both the first and second magnetic assemblies 200a, 200b have been delivered and are effectively coupled to each other (but still held within the slot 106), the surgeon need only pull back on the delivery device 100, which then brings the magnetic assemblies 200a, 200b into contact with the distal end 104, forcing the two halves of the distal end 104 to separate, allowing the distal end of the delivery device 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 and then form an anastomosis between the organs (i.e., an anastomosis between the duodenum and the common bile duct).

[0131] When deployed, each magnetic assembly has a width and length that generally correspond to approximately twice the width and length of each segment. As a result, when coupled together, a pair of magnetic assemblies form a generally substantially linear package, and the shape of the resulting anastomosis may be generally rectangular, but may also be circular or elliptical. The resulting anastomosis may have a 1:1 aspect ratio relative to the dimensions of the magnetic assembly. However, the exemplary embodiment allows for a larger aspect ratio (i.e., the formation of a larger anastomosis relative to the dimensions of the magnetic assembly). In particular, prior art systems and methods involving the use of magnets to form anastomoses are generally limited based on 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 the magnetic assembly overcomes such limitations.

[0132] For example, the design of the magnetic assembly, 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 a resulting anastomosis that is larger in size relative to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomosis may have an aspect ratio ranging from 2:1 to 10:1 or more.

[0133] 44A-44D are cross-sectional views showing various cross sections of the magnet segments of a magnetic assembly within the working channel of a standard scope. The magnet cross sections shown show polygonal as well as elliptical and circular shapes occupying 10-95 percent of the annular space of the working channel. With the guidelines on the magnetic cross sections in place, the next constraint on the device is an axial ratio of 6:1 minimum and 50:1 maximum. The segmented lengths can have either regular or irregular shapes when assembled in the body.

[0134] Figure 45 provides a list of some exemplary working channel sizes that may be used / viable for deploying a magnetic array with a cage to create an anastomosis. Scope channel sizes will increase and decrease as the market and devices change, so these sizes do not limit future possibilities. The sizing summary can be summarized as 1.0mm-6.0mm (including a bleed scope called a "thrombus buster") with one particular size device designed for approximately 3.7mm.

[0135] Thus, the delivery device of the present disclosure creates a low-profile linear anastomosis that allows for the mitigation of certain complications, particularly those involving common bile duct obstruction. In particular, patients suffering from common bile duct obstruction often undergo some procedure to remove the obstruction or allow for drainage resulting in the mitigation of jaundice / infection and porta hepatica complications. A common procedure is sphincterotomy or some kind of drainage stent placement procedure. There are procedures that provide decompression of the bile duct in a conventional manner, but are not possible in a minimally invasive manner. Such procedures include, for example, sphincterotomy, but sphincterotomy is not possible based on the inability to cannulate the common bile duct, and the inability to take into account anatomical changes, especially during severe disease conditions. The utilization of a cross section with a magnetic closing force as described herein allows for minimal bleeding and creates a semi-permanent slit cross section. This slit cross section will help resist "sump syndrome" and create a drainage point that will remain effectively infection-free.

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

[0137] FIG. 46 is a schematic diagram showing multiple magnetic segments 16a, 16b being fed through a single conduit according to one exemplary embodiment. This example shows two magnetic segments 16a and 16b being fed through a single conduit 14, such as a laparoscope or other feeder having an elongated body and a lumen extending therethrough and shaped and / or sized to receive and pass multiple magnetic segments. Generally, each of these magnetic segments 16a, 16b, when fed, forms a magnetic compression anastomosis device 16 (sometimes referred to herein simply as a "magnet") by self-assembly or other mechanisms described herein. Generally, different magnetic segments (e.g., magnetic compression anastomosis device) are fed into different body cavities, for example to capture two separate lumens for anastomosis, as described further below, although technically different magnetic segments may be fed into the same body cavity. 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 delivery of magnetic segment 16b while retaining magnetic segment 16a within the conduit for later delivery. It should be noted that while the "shish kebab" concept has been described herein in the context of esophagojejunostomy, the concept is not limited to any particular procedure or number of magnetic segments delivered. Thus, for example, the concept may be used to deliver two, three, or more magnetic segments.

[0138] FIG. 47 is a schematic diagram showing details of the separator segment 331 according to one exemplary embodiment. Among other things, the separator segment 331 includes ferrous connectors 343 at each end that maintain 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 centering of the magnet 16. The key or locking mechanism is shown in more detail in FIG. 56. When the magnet is deployed from the delivery device, the key or locking mechanism is extended through the distal end of the delivery device. The suture attached to the magnet is centered by the centering mechanism and controlled by the surgical handle shown in FIG. 49. After the magnet is deployed and self-assembled, the key is adapted to magnetically couple to the magnet based on the ferrous connector. The connector engages the magnet and allows the key to manipulate the magnet for proper placement at the target site, as shown in FIGS. 57A-57J. Once the distal and proximal magnets are paired, the key can be removed since the magnetic force of the key is less than the attractive force between the magnets. The key is then retracted into the delivery device and removed from the patient.

[0139] FIG. 48 is a schematic diagram showing how the separator segment shown in FIG. 47 can 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 run from the device handle through the centering mechanism of the separator segment to the two magnets. Once the two magnets are deployed, the separate suture / control lines can be used to control the magnets via a surgical handle device as shown in FIG. 49 to draw the magnets into close proximity and magnetically couple them together, thereby capturing tissue in two lumens, e.g., for anastomosis. Ferrous or magnetic members in the separator segments can engage the magnets and additionally control and deploy the magnetic device.

[0140] FIG. 49 is a schematic diagram showing a laparoscopic handle having controls 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 pull and / or push each line independently, thereby achieving and maintaining laparoscopic "cut" (hole) capture. The handle may include a button to cut the lines and a button to capture the lines to maintain tension on the lines, as shown in FIG.

[0141] 50A-50E, one exemplary procedure using the "shish-kebab" concept is described. In FIG. 50A, a shaft member pierces the target tissue from the patient's body cavity toward the proximal lumen with a piercing or cutting member to create an intestinal incision. The shaft then advances through the tissue wall on the opposite side of the proximal lumen to create an exit incision as shown in FIG. 50A, and advances through the tissue wall of the distal lumen to create an entry incision. The shaft member includes two linear self-forming compression members. In FIG. 50B, a surgical handle device is used to deliver a first self-forming compression member into the distal lumen. The first self-forming compression member is deployed and controlled by the handle device and 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 delivery device to a surgical handle at the proximal end. The tension control member is manipulated by the surgical handle device at the proximal end of the delivery device. In FIG. 50C, the shaft member is retracted back into the proximal lumen through the entry and exit incisions while the first self-forming compression magnet remains in the distal lumen. In FIG. 50D, the 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 the proximal magnet, thereby aligning it with the distal magnet and bringing it to the target site in the tissue wall. FIG. 50E illustrates diagrammatically the surgical handle device prepared to couple the two deployed self-forming compression members, for example, by manipulating a tether or tensioning device between the two self-forming compression members to draw them into proximity with each other until they automatically and magnetically couple, thereby forming an anastomosis. The tension control members are then cut, releasing the anastomosis device to be left inside the patient, while the tension control members are retracted into the delivery device and removed from the patient, leaving the exit and entrance incisions open to allow the passage of fluids and other materials through the resulting anastomosis.The delivery device is then withdrawn through the initial enterotomy and then removed from the patient. The initial enterotomy may be closed using sutures or the like.

[0142] The proximal anastomotic device may be deployed before the distal anastomotic device. In the proximal lumen first, the delivery device can deploy the proximal anastomotic device before exiting the proximal lumen and entering the distal lumen. Once the proximal anastomotic device is deployed, the delivery device is advanced into the distal lumen where the distal anastomotic device is deployed.

[0143] The following is an example of a "shish kebab" concept associated with performing a duodenal / ileal attachment, according to one exemplary embodiment. First, the surgeon locates an area of ​​the ileum where attachment to the duodenum is desired, crushes the ilium in the foregut to the area of ​​the duodenum, punctures the ileal tissue wall with the feeder, and enters the ileum with the feeder, e.g., using monopolar energy to burn through the ileal tissue wall (e.g., FIG. 50A). While inside the ileum, the surgeon selects an ileal exit point at the opposite ileal wall, and punctures the ileal tissue wall, e.g., using monopolar energy to burn through the ileal tissue wall (e.g., FIG. 50A). Next, the surgeon selects an area for entry into the duodenum, punctures the duodenal tissue wall, and enters the duodenum (e.g., FIG. 50A). Once inside the duodenum, the surgeon deploys the first magnetic segment (e.g., FIG. 50B). The surgeon then pulls the feeder back into the ileum (e.g., FIG. 50C), raises the ileum towards the duodenum, and deploys a second magnetic segment within the ileum (e.g., FIG. 50D). Once both magnetic segments are deployed, the surgeon can position the two magnetic segments, for example, by pulling the two magnetic segments together using one or more tethers (e.g., FIG. 50E), or can otherwise align or self-align the two magnetic segments and magnetically couple, thereby capturing the two enterotomy segments. The feeder can then be removed through the original ileal enterotomy.

[0144] Thus, some exemplary embodiments include the ability to recapture the compression anastomosis device during deployment, including laparoscopic delivery and control of capture of multiple holes in the digestive system for the compression anastomosis device and / or control of the 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 segments at any time. The key or locking mechanism is fitted to the linear compression anastomosis device prior to self-assembly.

[0145] Additionally, in some exemplary embodiments, a surgical handle apparatus may be delivered with multiple self-forming compression members through a single conduit that effectively pierces the target tissue to deliver the self-forming compression members. The surgical handle apparatus may have various members forming a control system connected to the self-forming compression members to deploy, control, and release the self-forming compression members. The surgical handle apparatus may include an actuatable tension member, which allows for continuous contact between two or more self-forming compression members. The surgical handle apparatus may create alignment between two or more self-forming compression members.

[0146] 51A-51F, another concept using two engageable feeders is described. In this exemplary embodiment, the feeder is a laparoscope. FIG. 51A shows a schematic of a magnetail device with multiple magnetic compression anastomosis device segments loaded into the distal lumen prior to deploying the compression anastomosis device into the lumen. The feeder advances into the distal lumen by piercing the body cavity toward the distal lumen with a piercing member and / or cutting member at the distal end of the feeder. FIG. 51B shows a schematic of the distal magnetail device and magnetic segments after the compression anastomosis device has been deployed and controlled into the distal lumen. The distal magnetic anastomosis device is deployed into the distal lumen by the magnetail device through the distal end of the feeder. By pulling back the feeder, the magnetic anastomosis device is deployed into the distal lumen while the magnetail is attached to the distal magnetic anastomosis device but is still located within the body lumen as shown in FIG. 51B. FIG. 51C shows a schematic of a feeding device loaded and deployed within the proximal lumen, where the feeding device in this example includes 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, the capture mechanism is self-deploying (e.g., spring-loaded) 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., mechanisms for gripping and releasing anastomosis devices) may be used. FIG. 51D shows a schematic of a magnetic compression anastomosis device deployed and captured by the capture mechanism of the feeding device within the proximal lumen. In this example, the magnetic compression anastomosis device may be deployed through a channel extending through the capture device. As shown in FIG. 51D, the proximal end of the magnetail device within the body cavity is manipulated using a second laparoscopic device. The distal end of the delivery device punctures the distal tissue wall of the proximal lumen, thereby creating an intestinal incision. The magnetail device is manipulated by a second laparoscopic device into the intestinal incision created in the proximal lumen where it engages with a capture device within the proximal lumen. Figure 51E shows a schematic of the magnetail device captured by a concentrically positioned capture device.That is, in this case, the magnetail device can be retracted into the delivery device, thereby drawing the two compression anastomosis devices into close proximity substantially concentrically. Figure 51F shows a schematic of the magnetail device at least partially retracted into the delivery device, such that the two compression anastomosis devices are in close proximity and magnetically coupled to one another, thereby capturing and compressing the walls of the distal and proximal lumens, for example, for anastomosis. Note that in some exemplary embodiments, the magnetail device can be delivered using a capture device and then recaptured by the capture device.

[0147] 52 illustrates generally the components of a disposable magnetail device according to one exemplary embodiment, including, among other things, (a) a magnetic compression anastomosis device, (b) one or more sutures, (c) one or more control members that support the sutures, (d) a shaft member (which may be flexible or rigid), (e) a pulley mechanism member that is part of the suture control mechanism, and (f) a rotatable radial pulley movement member that can be used to extend or retract the sutures and, therefore, the magnetic compression anastomosis device.

[0148] 53 illustrates a schematic of multiple magnetail configurations, according to various exemplary embodiments. Among other things, the 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 the magnetic compression anastomosis device.

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

[0150] FIG. 54 shows a schematic of another concept (called a "hybrid" approach) that uses one endoscope and one laparoscope (as opposed to two endoscopes). In this example, a first magnetic compression anastomosis in the distal lumen is captured by a magnetic capture device controlled via the endoscope in the proximal lumen. The first magnetic compression anastomosis device is brought into proximity with a second magnetic compression anastomosis device in the proximal lumen via a magnetic capture device using the laparoscope in the distal lumen for guidance and optionally 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] 55 illustrates a schematic of a suture control handle for a feeding device, such as an endoscope or laparoscope, according to various exemplary embodiments, designed for single-handed manipulation of a suture. Among other things, the suture control handle includes one or more suture wheels that allow manipulation (e.g., tightening and / or loosening) of one or more sutures passing through the feeding device, one or more suture cut buttons that control one or more suture cut tools to cut the sutures, and a capture / release and / or locking mechanism that can hold the sutures in place and maintain tension applied to the sutures. In some embodiments, each suture is attached to a separate magnet, and each suture wheel operates its own individual magnet.

[0152] FIG. 56 illustrates diagrammatically a manipulation tool or "wand" that may be used to manipulate an anastomosis magnet (e.g., a magnetic compression anastomosis device) as described herein, according to various exemplary embodiments. Among other things, the manipulation tool includes a key for controlling the anastomosis magnet during delivery. The manipulation tool also includes a number of control magnets (two control magnets in this example, although alternative embodiments may include other numbers of control magnets) that may facilitate capture, centering, and manipulation of the anastomosis magnet. The manipulation tool also includes centering holes through which one or more centering sutures may be connected to the anastomosis magnet prior to delivery, thereby assisting in centering and capture of the anastomosis magnet. The centering sutures may be connected to and manipulated by a suture control handle of the type described above with reference to FIG. 55, for example, using a suture wheel that "wraps" the anastomosis magnet toward the manipulation tool until it is captured by the control magnet, and then using a suture cut button that cuts the centering sutures. The wand manipulation tool is extended from the delivery device after deployment of the magnetic anastomosis device. The wand can be manipulated within the patient's body cavity to engage the proximal or distal magnetic anastomosis device and bring it into proximity with the other magnetic anastomosis device using a ferrous member or magnet on the wand. The wand also has a keyed or hooked distal end for manipulating the magnet during deployment. The centering suture can be manipulated with a suture control handle that "wraps" the distal anastomosis device, thereby bringing it into contact with the proximal anastomosis device. Once the magnets are paired, the wand can be removed based on the magnetic attraction of the wand being less than that of the anastomosis device. The wand is then retracted into the delivery device and removed from the patient.

[0153] An exemplary use of such a manipulation tool will now be described with reference to Figures 57A-57J. Figure 57A is a photograph showing the distal end of a feeder inserted into a first lumen. Figure 57B is a photograph showing partial deployment of a first anastomosis magnet into the first lumen. Figure 57C is a photograph showing a first anastomosis device fully deployed into the first lumen. Figure 57D is a photograph showing the distal end of a feeder inserted into a second lumen. A suture connects the first anastomosis device connected to the feeder and ultimately to the suture control handle. Figure 57E is a photograph showing partial deployment of a second anastomosis magnet into the second lumen. Figure 57F is a photograph showing a second anastomosis device fully deployed into the second lumen. FIG. 57G is a photograph showing remote manipulation of the second anastomosis magnet using a manipulation tool (e.g., in this example, the second anastomosis device has been moved relative to the position of the second anastomosis device in FIG. 57F due to magnetic attraction between the second anastomosis device and the manipulation tool). Sutures connect the first and second anastomosis devices to a delivery device and ultimately to a suture control handle. FIG. 57H is a photograph showing capture of the second anastomosis device by the manipulation tool from outside the second lumen, i.e., the second anastomosis device is captured through the wall of the second lumen and can be manipulated from outside the second lumen. The manipulation tool engages the second anastomosis device via a magnet provided on the manipulation tool. FIG. 57I is a photograph showing the action of approximating the second anastomosis device to the first anastomosis device using the manipulation tool. FIG. 57J is a photograph showing coupling of the first and second anastomosis devices using the manipulation tool to guide the coupling. Although not shown, the manipulation tool is disengaged from the magnetic anastomosis devices based on the fact that the attractive force of the magnets or ferrous members on the manipulation tool is less than the attractive force between the magnetic anastomosis devices, and the manipulation tool is then retracted into the delivery device and removed from the patient.

[0154] Incorporation by Reference Throughout this disclosure, references and citations are made to other documents, such as patents, patent applications, patent publications, journals, books, articles, web content, etc. All such documents are hereby incorporated by reference in their entirety for all purposes.

[0155] Equivalent The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The above-described embodiments are therefore to be considered in all respects as illustrative rather than limiting the invention described herein. The scope of the present invention is thus indicated by the appended claims rather than the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

[0156] Potential claims Various embodiments of the present invention may be characterized by the potential claims recited in the paragraph following this paragraph (and preceding the actual claims provided at the end of this application). These potential claims form part of the written description of this application. Accordingly, the subject matter of the following potential claims may be presented as actual claims in a later proceeding, including this application or any application claiming priority based on this application. The inclusion of such potential claims should not be construed to mean that the actual claims do not cover the subject matter of the potential claims. Thus, a decision not to present these potential claims in a later proceeding should not be construed as a donation of that subject matter to the public. Nor are these potential claims intended to limit the various claims that may be pursued.

[0157] Potential subject matter that may be claimed without limitation (prefaced with the letter "P" to avoid confusion with the actual claims set forth below) includes:

[0158] P1. Controlled capture of multiple holes within the digestive system for laparoscopic delivery and compression anastomosis devices.

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

[0160] P3. Key capability to ensure control during deployment of the self-assembling compression anastomosis device. Ability to incorporate into the implant design in a linear position to allow the ability to deploy or retract the device at any time. The design shown is an example of a "key" concept that is fitted into the linear compression anastomosis device prior to self-assembly.

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

[0162] P5. Ability to capture enterotomy.

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

[0164] P7. A surgical handle apparatus having multiple self-forming compression members delivered through a single conduit that effectively pierces the target tissue to deliver the self-forming compression members.

[0165] P8. The surgical handle apparatus 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.

[0166] P9. The surgical handle apparatus may include an actuatable tension member, thereby allowing continuous contact between two or more self-forming compression members.

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

Claims

1. A system for delivering a compression anastomosis device, the system comprising: a delivery system including a distal compression anastomosis device and a proximal compression anastomosis device separated by a separator segment within a single conduit of the delivery system; The system further includes a pivotable tension member coupled to the distal compression anastomosis device and passing through a centering mechanism of separator segments within the single conduit.

2. The system of claim 1, wherein the delivery device is a laparoscope or an endoscope.

3. The system of claim 1, wherein the pivotable tension member comprises a suture or a wire.

4. The system of claim 1, wherein the separator segments are magnetic or non-magnetic.

5. A separator segment configured to maintain alignment between a distal compression anastomosis device and a proximal compression anastomosis device within a conduit of the delivery device; a separator segment including a key or locking mechanism configured to control and / or recapture at least one of said compressed anastomosis devices during or after delivery; The system of claim 1 , comprising at least one of:

6. The system described in claim 1, wherein the feed device includes a control device that controls the tension applied to the pivotable tension member, and in particular the control device is a wheel.

7. 1. A method for delivering a compression anastomosis device, the method comprising: providing a feeder including a distal compression anastomosis device and a proximal compression anastomosis device separated by a separator segment within a single conduit of the feeder, the feeder further including a pivotable tension member coupled to the distal compression anastomosis device and passing through a centering mechanism of the separator segment within the single conduit; penetrating the delivery device through the proximal tissue wall into the proximal lumen to create an enterotomy; penetrating the delivery device through a distal tissue wall of the proximal lumen into a body cavity to create an exit incision; the delivery device piercing a tissue wall of a distal lumen to create an entry incision, thereby entering the distal lumen; deploying the distal compression anastomosis device into the distal lumen via the delivery device; retracting the delivery device from the distal lumen through the entrance incision and into the proximal lumen through the exit incision; deploying the proximal compression anastomosis device into the proximal lumen via the delivery device; applying tension to the pivotable tension member passing through a centering feature of the separator segment to bring the distal compression anastomosis device to a target site against a tissue wall of a distal lumen for coupling with the proximal compression anastomosis device to form an anastomosis; cutting the pivotable tension member and retracting the pivotable tension member into the delivery device, thereby releasing the distal compression anastomosis device; retracting the delivery device from the proximal lumen, through the enterotomy, and into the body cavity for removal from the patient; A method comprising:

8. The method of claim 7 , wherein the delivery device is a laparoscope or an endoscope.

9. The method of claim 7, wherein the pivotable tension member comprises a suture or a wire.

10. The method of claim 7, wherein the separator segments are magnetic or non-magnetic.

11. A separator segment configured to maintain alignment between a distal compression anastomosis device and a proximal compression anastomosis device within a conduit of the delivery device; or a separator segment including a key or locking mechanism configured to control and / or recapture at least one of said compressed anastomosis devices during or after delivery; The method of claim 7, comprising at least one of:

12. The method of claim 7, wherein the feed device includes a control device that controls the tension applied to the pivotable tension member, and in particular the control device is a wheel.

13. The method of claim 7, further comprising removing the separator segment from the patient.

14. The method of claim 1, further comprising: deploying a control member into a proximal lumen via the delivery device; manipulating the proximal compression anastomosis device with the control member to press the proximal compression anastomosis device against a tissue wall of the proximal lumen to a target site for alignment of the proximal compression anastomosis device with the distal compression anastomosis device; The method of claim 7, further comprising:

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