CN117642126A - Mechanism for creating an intestinal incision between one or more pressing devices - Google Patents

Abstract

The present invention provides systems, devices, and methods for delivering, deploying, and positioning a magnetic expression device at a desired site to improve the accuracy of anastomosis creation between tissues, organs, and the like.

Description

Mechanism for creating an intestinal incision between one or more pressing devices

Cross Reference to Related Applications

The present application claims the benefit of U.S. provisional patent application No.63/177,192 (attorney docket No. 121326.11402) filed on day 20 at month 2021, entitled "MECHANISM TO CREATE LUMEN BETWEEN ONE OR MORE COMPRESSION DEVICES (mechanism for creating lumens between one or more press devices)" and U.S. provisional patent application No.63/257,933 (attorney docket No. 121326-11403) filed on day 20 at month 2021, entitled "MECHANISM TO CREATE LUMEN BETWEEN ONE OR MORE COMPRESSION DEVICES (mechanism for creating lumens between one or more press devices), the entire contents of both of which are incorporated herein by reference.

The subject matter of this patent application may be related to the subject matter of U.S. patent application Ser. No.17/108,840 (attorney docket No. 121326-11101), entitled "SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES (systems, devices and methods for forming anastomosis) filed on month 1 of 2020, which is part of and thus claims priority to International patent application Ser. No. PCT/US2019/035202 (attorney docket No. 121326-11102) filed on month 3 of 2019, which claims the benefit and priority of U.S. provisional application Ser. No. 62/679,810 filed on month 2 of 2018, U.S. provisional application Ser. No. 62/798,809 filed on month 1 of 2019, and U.S. provisional application Ser. No. 62/809,354 filed on month 22 of 2019, the contents of which are all incorporated herein by reference.

Technical Field

The present invention relates to deployable magnetic expression devices (deployable compression device), and more particularly, to systems, devices and methods for delivering, deploying and positioning magnetic expression devices at desired sites to improve the accuracy of anastomosis creation between tissues, organs, and the like.

Background

Bypasses to the Gastrointestinal (GI), cardiovascular or urinary systems are typically formed by cutting holes in tissue at two locations and joining the holes with sutures or staples. The bypass is typically arranged to route fluid (e.g., blood, nutrients) between healthier portions of the system while bypassing diseased or dysfunctional tissue. The procedure is often invasive and subjects the patient to risks such as bleeding, infection, pain, and adverse reactions to anesthesia. In addition, bypasses created with sutures or staples can be complicated by post-operative leakage and adhesions. Leakage can lead to infection or sepsis, while adhesions can lead to complications such as colic and obstruction. While conventional bypass surgery may be accomplished endoscopically, laparoscopically, or robotically, engaging holes cut into tissue can be time consuming. In addition, such procedures require specialized skill and equipment not available in many surgical institutions.

Instead of sutures or staples, the surgeon may use mechanical couplings or magnets to create a press fit between the tissues. For example, a press coupling or pair of magnets may be delivered to the tissue to be joined. Because of the strong compression, the tissue trapped between the coupling or magnets is severed from its blood supply. Under these conditions, the tissue becomes necrotic and degenerated, while new tissue grows around the pressing point (e.g., on the edge of the coupling). Over time, the coupling may be removed, leaving a healed anastomosis between the tissues.

However, difficulties in deploying magnets or couplings limit the locations where press anastomosis can be used. In most cases, the magnet or coupling must be delivered as two separate components, requiring an open surgical field or a bulky delivery device. For example, existing magnetic expression devices are limited to structures that are small enough to be deployed using a delivery catheter, such as an endoscopic instrument channel or laparoscopic port. When using these smaller structures, the anastomosis formed is small and suffers short term non-closure. In addition, the placement of the magnets or couplings may be inaccurate, thereby causing anastomosis at undesired or inaccurate locations.

Thus, there remains a continuing need in the clinic for reliable devices and minimally invasive procedures that facilitate the formation of a press fit between tissues in the human body.

Disclosure of Invention

Various embodiments of the present invention provide improved devices and techniques for minimally invasive anastomosis formation in vivo. Such devices and techniques facilitate faster and cheaper treatment of chronic diseases such as obesity and diabetes. This technique also reduces the time and pain associated with palliative treatment for diseases such as cancer.

For example, in some embodiments, an apparatus for deploying a compression anastomosis device includes a delivery device and a control member, one or more compression anastomosis devices can be deployed from the delivery device, and the control member can be deployed from a distal end of the delivery device. The control member may be manipulable such that it is aligned with one or more press anastomosis devices within the deployment channel of the delivery device.

In various other embodiments, the control member may be expandable such that it may be expanded to a diameter greater than the deployment channel diameter of the delivery device in order to expand the created intestinal incision (enteromy). The control member may also be collapsible such that it may be collapsed to a diameter less than or equal to the diameter of the deployment channel for removal from the patient.

In some embodiments, the control member may be basket, balloon cuff (balloon cuff), and/or wire jaw shaped.

In some embodiments, a control member may be deployed between the distal lumen and the proximal lumen to capture the formed intestinal incision. A control member may also be deployed into the distal side of the distal anastomosis device so as to act as a stop control device.

In various embodiments, the piercing device can be deployable from a delivery device and can pierce, dissect, and/or dilate tissue to create a deployment channel between two lumens. In some embodiments, the piercing device may be a hot needle, a hot tip that emits monopolar energy, a coring needle, and/or a spiral (corkscrew).

Various embodiments may include a method for positioning a press-fit device, the method comprising deploying a first press-fit device from a distal end of a delivery device into a proximal lumen. The first press anastomosis device can then be positioned against the tissue wall, and the tissue can be pierced to create an intestinal incision into the distal lumen. The control member may then be deployed into the intestinal incision, and the intestinal incision is then expanded. The control member may then be engaged with the second stapling device, and the control member may be rotationally and/or laterally maneuvered relative to the distal stapling device to align the two stapling devices. The anastomosis device can then be brought together to capture the intestinal incision. In some embodiments, the control member may then be retracted to a diameter less than or equal to the delivery device diameter and retracted into the delivery device for removal from the patient.

In various embodiments, a control member may be deployed between the anastomosis devices to capture an intestinal incision.

In other embodiments, an apparatus for deploying a compression anastomosis device includes a delivery device having the ability to cut, dissect, and/or dilate tissue to create an intestinal incision between adjacent lumens. The control member may be deployed into the intestinal incision from the distal end of the delivery device to capture the intestinal incision. The control member may also be expanded to a diameter greater than the diameter of the intestinal incision in order to dilate the intestinal incision. The control member may also be rotationally and/or laterally steerable to engage a distally deployed anastomosis device and align and mate the distal anastomosis device with a proximal anastomosis device. The control member may then be retracted to a diameter less than or equal to the diameter of the delivery device and retracted into the delivery device.

In some embodiments, a control member may be deployed to the distal side of the distal anastomosis device to act as a stop.

In various embodiments, the control member may be basket, balloon sheath, and/or wire-controlled jaw shaped.

Drawings

Features and advantages of the claimed subject matter will become apparent from the following detailed description of embodiments thereof, which proceeds with reference to the accompanying drawings.

Fig. 1 is a schematic view of an anastomosis formation system according to the present disclosure.

Fig. 2 shows several potential anatomical targets for anastomosis formation, where arrow a is stomach to small intestine, arrow B is small intestine to large intestine, arrow C is small intestine to small intestine, arrow D is large intestine to large intestine, and arrow E is stomach to large intestine.

Fig. 3 illustrates an exemplary magnetic anastomosis device delivered through an endoscopic instrument channel such that individual magnet portions self-assemble into a larger magnetic structure (in this particular case, into an octagon).

Fig. 4A depicts two magnetic anastomosis devices attached to each other by tissue. As shown, these devices each include eight magnetic portions, however alternative configurations are possible.

Fig. 4B shows two magnetic anastomosis devices coupled together by magnetic attraction to capture intervening tissue.

Fig. 5A shows a needle delivering a first magnetic device into a first portion of a hollow body at a target site.

Fig. 5B illustrates the subsequent deployment of a second magnetic device into a second portion of the hollow body adjacent the target site.

Fig. 6A shows an endoscopic ultrasound guided needle delivering a magnet assembly into the gallbladder, which is then coupled with a second magnet assembly in the stomach or duodenum, as shown in fig. 6B.

Fig. 7 illustrates a single guide element for deploying and manipulating a magnetic anastomosis device.

Fig. 8A, 8B, 8C, 8D, 8E, and 8F each depict deployment of a self-closing magnetic anastomosis device utilizing a plurality of guide elements.

Fig. 9, 10, 11 and 12 illustrate various methods of accessing a target site (specifically, accessing the gallbladder) specifically via an endoscopic ultrasound guided procedure.

Fig. 9 illustrates the use of monopolar energy to pierce and access the gallbladder.

Fig. 10 illustrates the use of a thin aspiration needle (FNA) to pierce and access the gallbladder.

Fig. 11 illustrates the use of a helical needle to pierce and access the gallbladder.

Fig. 12 illustrates the use of a guidewire through the bile duct and into the gallbladder.

Fig. 13 shows an endoscopic ultrasound guided needle penetrating the gallbladder to access the interior of the gallbladder, followed by delivery of the magnet assembly thereto.

Fig. 14, 15, 16 and 17 illustrate various devices for anchoring an access device and/or a delivery device to a target site at the gallbladder. Fig. 14 illustrates a T-bar member. Fig. 15 illustrates a nitinol coil (e.g., "pig tail"). Fig. 16 illustrates a balloon member of a catheter. Fig. 17 illustrates a malecot catheter (malecot).

Fig. 18A, 18B, 18C, 18D, 18E and 18F 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.

Fig. 19 illustrates a variation of the design of fig. 18A-18F, particularly with a balloon to deliver a single magnetic anastomosis device into the gall bladder, rather than a pair.

Fig. 20A, 20B and 20C illustrate a method of ultrasonically guiding into and utilizing a thermal insertion tube emitting monopolar energy to access the gallbladder via an endoscope, followed by delivering a magnetic anastomosis device into the gallbladder via the thermal insertion tube.

Fig. 21A, 21B, 21C, 21D and 21E illustrate a technique of accessing the gallbladder and delivering a pair of magnetic anastomosis devices to form an anastomosis between the gallbladder tissue and adjacent tissue (i.e., stomach or duodenal tissue).

Fig. 22A, 22B and 22C illustrate variations of the procedure and device illustrated in fig. 21A-21E, wherein a magnetic anastomosis device is preloaded into the distal end of the marlecite catheter of the delivery device, resulting in delivery and deployment of the device after the marlecite end transitions to the anchoring position.

Fig. 23 illustrates a marzicot catheter with its distal end expanded to an anchoring position on one side of the gallbladder tissue wall.

Fig. 24 illustrates a marzicot catheter with its distal end expanded to an anchoring position on both sides of the gallbladder tissue wall.

Fig. 25A, 25B, 25C, 25D and 25E 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 (i.e., stomach or duodenal tissue).

Fig. 26A, 26B, 26C illustrate a variation of the procedure and device illustrated in fig. 25A-25E, wherein the deployment sheath includes a notch (notch) on its distal end configured to engage the T-bar after advancement through the intestinal incision, thereby pushing the T-bar to a side that allows for subsequent delivery and deployment of the magnetic anastomosis device.

Fig. 27A, 27B and 27C illustrate another variation of the procedure and device illustrated in fig. 25A-25E, wherein the assembly of fig. 27A-27C relies on placement of the T-bars by accessing the needle rather than including a deployment sheath for delivering a self-assembled magnetic anastomosis device as previously described herein, such that a set of T-bars are configured to self-assemble into an array and serve as a distal anastomosis device to correspondingly mate with a proximal magnetic anastomosis device on the other side to subsequently squeeze tissue therebetween to form an anastomosis.

Fig. 28A, 28B and 28C illustrate a method of accessing a gallbladder via endoscopic ultrasound-guided access needle access using a side port deployment sheath for delivering and deploying a pair of magnetic anastomosis devices.

29A, 29B and 29C illustrate a knotting element configured to secure a magnetic anastomosis device, which has been deployed and positioned, to a target site tissue and subsequently cut a guide element or suture coupled thereto.

Fig. 30A, 30B, 30C and 30D 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.

Fig. 31A and 31B illustrate a collection of magnetic portions pre-packaged with unstable polarity, including a plurality of guide elements, tethers, or sutures that interconnect adjacent portions to facilitate self-assembly of the magnetic portions into a polygonal deployment shape.

Fig. 32A and 32B illustrate a method of ultrasonically guiding, via an endoscope, into and accessing the gallbladder with an access device having a conductor with a "hot" tip that emits monopolar energy, followed by delivering the pre-packaged magnetic portion of fig. 31A and 31B through a sheath into the gallbladder.

33A, 33B and 33C illustrate a method of ultrasonically guiding through an endoscope into and utilizing a needle into a gallbladder to access the gallbladder and then delivering a coiled stack of magnetic portions configured to act as a distal anastomosis device to correspondingly mate with a proximal magnetic anastomosis device disposed on the other side to subsequently squeeze tissue therebetween to form an anastomosis.

Fig. 34A and 34B 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 (i.e., stomach or duodenum tissue).

Fig. 35 illustrates a magnetic anastomosis device including a continuous guide element or suture coupled to a plurality of magnetic portions of the device through eyelets provided on each of the plurality of magnetic portions of the device.

FIG. 36 illustrates one embodiment of a suture cutting arrangement within a deployment sheath or auxiliary device of a delivery device for cutting a suture coupled to a magnetic anastomosis device.

Fig. 37A and 37B are enlarged side views illustrating an anvil/tip (37A) arrangement and a tip/tip (37B) arrangement for cutting a suture.

Fig. 38 illustrates a loop breaker device (auxiliary device) configured to be inserted over a guide element or suture coupled with a magnetic anastomosis device and configured to cut the guide element or suture once it has been deployed and positioned at a target site.

Fig. 39A illustrates a loop breaker device including a resistive heating element for cutting a guide element.

Fig. 39B and 39C illustrate a loop breaker device including a loop member having a cutting edge for cutting a guide element.

Fig. 39D illustrates an auxiliary device configured to provide suture or guide element cutting with monopolar/bipolar energy.

Fig. 40 illustrates the guide element or suture separated.

Fig. 41A and 41B illustrate a removable suture assembly.

FIG. 42 illustrates a perspective view of another embodiment of a magnetic assembly according to the present disclosure.

Fig. 43A illustrates advancement of the distal tip of the delivery device through the respective tissue walls of adjacent organs at the target site to subsequently form an anastomosis therebetween.

Fig. 43B is an enlarged view of the distal end of the delivery device, illustrating the slot extending completely through one side of the delivery device body.

Fig. 43C illustrates delivery of the first magnetic assembly into the first organ.

Fig. 43D illustrates deployment of the first magnetic assembly into the first organ while remaining within the slot of the delivery device.

Fig. 43E illustrates the first magnetic assembly fully deployed within the first organ and the delivery device pulled back thereby pulling the first magnetic assembly against the wall of the first organ in preparation for delivery and deployment of the second magnetic assembly in the second organ.

Fig. 43F illustrates delivery of the second magnetic assembly into the second organ.

FIG. 43G is an enlarged view in partial cross-section of the second magnetic assembly advanced to a deployed state.

Fig. 43H illustrates the first and second magnetic assemblies in a fully deployed state and coupled to each other due to magnetic attraction therebetween.

Fig. 43I illustrates a distal end of a delivery device constructed of two halves and configured to be split to allow the delivery device to be removed from a target site while the pair of magnetic assemblies remain coupled to each other to form an anastomosis at the target site.

44A, 44B, 44C and 44D are cross-sectional views of various contours of the magnet portion of the magnet assembly within the working channel of a standard mirror.

FIG. 45 provides a list of some exemplary working channel dimensions that are considered to be usable/feasible for deploying a magnetic array with a cage to produce anastomosis.

Fig. 46 is a schematic diagram illustrating two exemplary cutting mechanisms, specifically a mechanical cutting mechanism and an electronic cutting mechanism (e.g., tissue inactivation (deseeding) using RF or electrode/heat between one or more inactivation (deseeding) devices).

FIG. 47 is a schematic diagram illustrating a coring needle (core) device, according to an example embodiment.

Fig. 48 is a schematic diagram illustrating a thermal needle device according to an example embodiment.

Fig. 49 and 50 illustrate various exemplary embodiments of mechanisms/tools for creating an intestinal incision between press anastomosis devices.

Fig. 51 illustrates three expandable/contractible configurations for providing stop (backstop) control and manipulation of an anastomosis device, according to various exemplary embodiments.

Fig. 52 illustrates three expandable/contractible configurations providing affirmative control and manipulation of an anastomosis device, in accordance with various exemplary embodiments.

Fig. 53 illustrates two tip configurations in accordance with various exemplary embodiments.

Fig. 54A shows the device extended into the distal lumen and the distal magnet (a) deployed when the proximal magnet is deployed into the proximal lumen. Deploying a jaw control mechanism (B). The distal magnet is manipulated (C) by a jaw (jaw) as a support.

Fig. 54B shows a side view of the device extended into the distal lumen and deploying the distal magnet when the proximal magnet is deployed into the proximal lumen. A wire controlled jaw control member is deployed. The distal magnet is manipulated by a wire aperture jaw control member that acts as a support.

Fig. 55A shows a single magnet being deployed, a wire-controlled jaw control member being deployed, and a single magnet being manipulated with the jaws acting as a support.

Fig. 55B shows a side view of a single magnet being deployed, a wire controlled jaw control member being deployed, and a single magnet being maneuvered with the wire controlled jaw control member acting as a support.

Fig. 56A shows the device extended into the distal lumen and the distal magnet deployed when the proximal magnet is deployed into the proximal lumen. The basket control member extends and expands up to the diameter of the magnet. The distal magnet is manipulated by a basket control member that acts as a support.

Fig. 56B shows a side view of the device extending into the distal lumen and deploying the distal magnet when the proximal magnet is deployed into the proximal lumen. The basket control member extends and expands up to the diameter of the magnet. The distal magnet is manipulated by a basket control member that acts as a support.

Fig. 57A shows a single magnet being deployed, a basket control member being deployed (the basket control member expands up to the magnet diameter), and a single magnet being maneuvered with the basket control member acting as a support.

Fig. 57B shows a side view of a single magnet being deployed, a basket control member being deployed (the basket control member expanding up to the magnet diameter), and a single magnet being maneuvered with the basket control member acting as a support.

Fig. 58 shows a side view of the proximal magnet deployed into the proximal lumen, the catheter pushed out releasing the balloon control member and distal magnet into the distal lumen. The balloon is then inflated in the distal lumen and the catheter is pulled until the distal magnet is maneuvered by the balloon control member and the distal magnet is attached to the proximal magnet.

For a thorough understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in conjunction with the above-described drawings. Although the present disclosure has been described in connection with the exemplary embodiments, it is not intended to be limited to the specific form set forth herein. It is to be understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient.

Detailed Description

The exemplary embodiments provide improved devices and techniques for minimally invasive anastomosis formation in vivo (e.g., within the gastrointestinal tract). Such devices and techniques facilitate faster and cheaper treatment of chronic diseases such as obesity and diabetes. This technique also reduces the time and pain associated with palliative treatment for diseases such as cancer (such as gastric or colon cancer).

The illustrative embodiments significantly improve deployment of the press stapling device by deploying a control member to engage the poles of the distal stapling device, the orienting device, and bringing a pair of stapling devices together.

In an exemplary embodiment, the deployment device deploys the anastomosis device into the proximal lumen and then pierces the adjacent wall to the lumen into the distal lumen. The deployment device then deploys the distal anastomosis device into the distal lumen. The control member is deployed into the space between the lumens and has been in a contracted position in the deployment device, expanding to a size larger than the aperture between the lumens, thereby expanding the intestinal incision. The control member is then engaged with the distal anastomosis device, orienting the polarity to complement that of the proximal anastomosis device, and applying a force to bring the devices together. The control member is then contracted to its original size and removed from the lumen into the deployment device.

The system generally includes an access device configured to be disposed within a hollow body of a patient and to facilitate forming an anastomosis at a target site (desired anatomical location) within the hollow body to form an anastomosis between a first portion of tissue of the hollow body and a second portion of tissue of the hollow body at the target site. The access device is configured to provide access to the first and second portions of tissue of the hollow body and also to deliver and position the 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 implantable magnetic anastomosis device and the second implantable magnetic anastomosis device are configured to magnetically attract each other through a defined tissue region of a combined thickness of the tissue wall at the target site and to exert a compressive force on the defined region to form an anastomosis.

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 a gallbladder, and control members for ensuring that the access devices are positioned for subsequent deployment of one of a pair of magnetic anastomosis expression devices. The systems, devices, and methods described herein also include various delivery devices for delivering at least one of a pair of magnetic anastomosis expression devices to a target site, wherein in some instances, delivery devices according to the present disclosure may facilitate deployment and subsequent fixation to the target site and/or interconnection of the pair of magnetic anastomosis expression devices. The systems, devices, and methods described herein include various embodiments of control members for ensuring deployment of a magnetic anastomosis press device, as well as various designs for transitioning from a compact delivery configuration to a larger deployment configuration, typically by self-assembly design.

More specifically, exemplary embodiments provide a system including a delivery device for introducing and delivering a pair of magnetic assemblies between adjacent organs via minimally invasive techniques to bridge tissue walls of each organ together, thereby forming a passageway (i.e., anastomosis) therebetween. The delivery device is particularly useful for delivering the pair of magnet assemblies to a target site within the gastrointestinal tract, thereby forming an anastomosis between the stomach wall and the gallbladder wall to provide adequate drainage from the gallbladder in the event of an occlusion (due to disease or other health-related problems). The system further includes a control member for aligning and pairing the collection of press fit devices at a desired target site.

Thus, the exemplary embodiments provide improved devices and techniques for minimally invasive anastomosis formation in vivo (e.g., within the gastrointestinal tract). Such devices and techniques facilitate faster and cheaper treatment of chronic diseases such as obesity and diabetes. This technique also reduces the time and pain associated with palliative treatment for diseases such as gastric or colon cancer.

Fig. 1 is a schematic view of an anastomosis formation system 10 for providing improved deployment of magnetic anastomosis devices 16, 200 at a desired site to enhance the accuracy of creating an anastomosis 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 apparatus 18.

The access device 14 may generally comprise a speculum 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, including 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 both magnetic devices 16, 200. As will be described in greater detail herein, a surgeon may advance endoscope 14 within the hollow body of patient 12 and position endoscope 14 at a desired anatomical location for forming an anastomosis based on the visual depiction of the target site location provided by the imaging device. For example, the imaging device may include a display, wherein an image or other visual depiction illustrating 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 a combination thereof. Then, as the endoscope is advanced through the hollow body, the surgeon may rely on such visual depictions to position the access device 14 at a portion of tissue at the target site that is adjacent to other portions of tissue, thereby ensuring that the deployment of the magnetic devices 16, 200 is accurate.

It should be noted that the hollow body through which the access device 14 may pass includes, but is not limited to, the stomach, gall bladder, pancreas, duodenum, small intestine, large intestine, intestines, vasculature (including veins and arteries), and the like.

In some embodiments, the self-assembled magnetic device is used to form a shunt in the gastrointestinal tract. Such bypasses may be used to treat cancerous obstruction, weight loss, or obesity, or even to treat diabetes and metabolic diseases (i.e., metabolic surgery). Fig. 2 illustrates various gastrointestinal anastomosis targets that may be addressed with the devices of certain example embodiments, such targets including stomach-to-small intestine (a), stomach-to-large intestine (E), small intestine-to-small intestine (C), small intestine-to-large intestine (B), and large intestine-to-large intestine (D). Accordingly, the exemplary embodiments provide improved devices and techniques for minimally invasively forming anastomosis in vivo (e.g., within the gastrointestinal tract). Such devices and techniques facilitate faster and cheaper treatment of chronic diseases such as obesity and diabetes. This technique also reduces the time and pain associated with palliative treatment for diseases such as gastric or colon cancer.

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

During an endoscopic procedure, a single endoscope 14 may be used to deliver the self-assembled magnetic device. The deployment of the magnetic device 16 is generally illustrated in fig. 3. As shown, an exemplary magnetic anastomosis device 16 may be delivered through endoscope 14 such that individual magnet portions self-assemble into a larger magnetic structure, in this particular case, into an octagon. When used with the techniques described herein, if the device is deployed as a complete assembly, the device 16 allows for the delivery of larger magnetic structures via a small delivery catheter (such as in a standard endoscope) than would otherwise be deliverable. Further, the larger magnet structure allows for the creation of a stronger, larger anastomosis and greater surgical success. For example, in some cases, the resulting anastomosis may have an aspect ratio of 1:1 relative to the final dimensions of the assembled magnetic device. However, the exemplary embodiments allow for a greater aspect ratio (i.e., a greater anastomosis with respect to the size of the magnetic assembly). In particular, prior art systems and methods involving the use of magnets to create anastomosis are generally limited based on the size of the working channel of the endoscope or catheter used to deliver such magnets, which in turn limits the resulting size of the anastomosis. However, the magnetic assembly design of the exemplary embodiments overcomes such limitations. For example, the design of the magnetic assembly, particularly the interconnection of the magnetic portions via the exoskeleton, allows for any number of portions to be included in a single assembly, and thus the resulting anastomosis has a larger size relative to the size of the working channel of the speculum. For example, in some embodiments, the resulting anastomosis may include an aspect ratio in the range of 2:1 to 10:1 or greater. Such aspect ratios are described in more detail with respect to fig. 44A, 44B, 44C, and 44D.

Because the magnetic device is radiopaque and echogenic, fluoroscopy, direct visualization (transmission illumination or tissue stamping), and ultrasound (e.g., endoscopic ultrasound) can be used to position the device 16. The device 16 may also be decorated with radio-opaque paint or other indicia to help identify the polarity of the device during deployment.

Magnetic anastomosis device 16 generally includes a magnetic portion that can assume a delivery configuration and a deployment configuration. The delivery configuration is generally linear so that the device can be delivered to tissue via a laparoscopic "keyhole" incision, or via a natural path (e.g., via the esophagus) with endoscope 14 or similar device. In addition, the delivery configuration is typically somewhat flexible so that the device can be guided through various curves in the body. Once the device is delivered, the device will assume the desired shape and size of the deployed configuration by automatically transitioning from the delivery configuration to the deployed configuration. The rotation from the delivery configuration to the deployment configuration is guided by a coupling structure that moves the magnetic parts in a desired manner without intervention. Exemplary self-assembling magnetic anastomosis devices 16, such as self-closing, self-opening, and the like, are described in U.S. patent No.8,870,898, U.S. patent No.8,870,899, U.S. patent No.9,763,664, and U.S. patent No.10,182,821, the contents of each of which are incorporated herein by reference in their entirety.

Generally, as shown in fig. 4A, the magnetic anastomosis procedure involves disposing first and second magnetic structures 16a and 16b adjacent first and second portions 20 and 24, respectively, of tissue 26, thereby bringing tissue 22 and 26 together. Once the two devices 16a, 16b are brought together, the magnetic structures 16a, 16b mate and bring the tissues 22, 26 together. Once the two devices 16a, 16b are mated, the tissue trapped between the devices will necrose, thereby causing anastomosis to form. Alternatively, the tissue 22, 26 joined by the devices 16a, 16b may be perforated after the devices are mated to form a direct anastomosis. Over time, an anastomosis of the size and shape of the devices 16a, 16b will be formed, and the devices will fall out of the tissues 22, 26.

Alternatively, because the mated devices 16a, 16B create sufficient compressive force to prevent blood from flowing to the tissue 22, 26 captured between the devices, the surgeon may form an anastomosis by making an incision in the tissue 22, 26 enclosed by the devices, as shown in fig. 4B. In some cases, an endoscope may be used to cut through the enclosed tissue.

In another embodiment, as will be described in greater detail herein and shown in fig. 43A-43I, a surgeon may first cut or pierce tissue 22, 26 and then deliver magnetic device 16a, 200a into portion 20 of the hollow body to deploy device 16a, 200a around an incision in tissue 22. The surgeon may then deploy the devices 16b, 200b in the portion 24 of the hollow body to deliver the devices 16b, 200b around the incision in the tissue 26, and then allow the devices 16a, 200a and 16b, 200b to be coupled to one another such that the devices 16a, 16b (200 a, 200 b) surround the incision. As before, once the devices 16a, 16b (200 a, 200 b) are mated, blood flow to the incision is rapidly shut off.

While the drawings and structures of the present disclosure relate primarily to annular or polygonal structures, it is to be understood that the delivery and construction techniques described herein may be used to fabricate a variety of deployable magnetic structures. For example, the self-assembled magnets may be reassembled into polygonal structures such as circles, ovals, squares, hexagons, octagons, decagons, or other geometric structures that form a closed loop. The device may also include handles, suture loops, barbs, and protrusions as needed to achieve the desired properties and to facilitate delivery (and removal). However, in other embodiments, a magnetic assembly, such as magnetic assembly 200 of fig. 42, may include a pair of magnetic portions arranged in generally linear alignment with each other (e.g., aligned in an end-to-end fashion) and coupled together via a flexible exoskeleton element. Such embodiments will be described in more detail herein.

As previously described, the self-assembled magnetic anastomosis device may be delivered to the target site via the access device 14. For example, as shown in fig. 5A, the access device 14 may include a delivery needle 28 (e.g., an aspiration needle) for delivering the first magnetic anastomosis device 16a into the lower small intestine (by piercing), followed by deployment of the second magnetic device 16B into the upper small intestine at a location on tissue adjacent to the target site (shown in fig. 5B). It should be noted that delivery may be guided using fluoroscopy or endoscopic ultrasound. After self-assembly, these small intestine magnetic devices 16a, 16b are coupled to each other (e.g., magnetically attracted to each other) through a defined tissue region of combined thickness of the tissue wall at the target site, and a pressing force is applied over the defined region to form an anastomosis.

Fig. 6A shows an endoscopic ultrasound guided needle delivering a magnet assembly into the gallbladder, which is then coupled with a second magnet assembly in the stomach or duodenum, as shown in fig. 6B. Accordingly, the described procedure may also be used with procedures that remove or block bypassed tissue. For example, endoscopic Ultrasound (EUS) may be used to facilitate guided transgastric or duodenal access into the gallbladder to deploy a self-assembled magnetic anastomosis device. Once access to the gallbladder is achieved, various strategies may be employed to maintain an open entrance between the stomach 10 and the gallbladder 11 or between the duodenum 76 and the gallbladder 11. In another embodiment, the gall stones may be removed and fluid removed through an endoscope. For example, using the described methods, an anastomosis may be created between the gallbladder and the stomach. Once the gall bladder is accessed by gastric or duodenal means, the gall bladder stones may be removed. In addition, any number of modes may be used to ablate the gallbladder mucosa including, but not limited to, argon Plasma Coagulation (APC), photodynamic therapy (PDT), sclerosants (e.g., ethanolamine or ethanol).

Fig. 7 illustrates a single guide element 30 for deploying and manipulating the magnetic anastomosis device 16. For example, it may be beneficial to be able to manipulate the position of the device 16 once the self-assembled magnetic device has been delivered to tissue. While the device 16 may be manipulated with conventional tools, such as forceps, it is often simpler to manipulate the position of the deployed device 16 with a guide element 30, such as a suture or wire. As shown in fig. 7 and 8A-8F, various attachment points may be used to provide control over the position and deployment of the self-assembled magnetic anastomosis device 16. For example, as shown in fig. 7, the guide element 30 may be coupled to a single distal portion such that, upon self-assembly, the single distal portion results in an attachment point that provides translational freedom of movement. It is also noted that the configuration shown in fig. 7 also allows for the application of a closing force to the distal-most portion. That is, the proximal pulling force provided by guide element 30 may assist device 16 in completing self-assembly in situations where one or more portions should become entangled with tissue or otherwise be prevented from self-assembly. Once self-assembly is complete, device 16 may be positioned using guide element 30 to mate with another device (not shown) to form an anastomosis, as described above. Although not shown in fig. 7, it is contemplated that additional structures such as solid pushers or guide tubes may be used to deploy the device 16 to a desired location, and that control members may be used to orient and engage the device 16.

The guide element 30 may be made of a variety of materials to achieve desired mechanical properties and biocompatibility. The guide element 30 may be composed of metal (e.g., wire, stainless steel wire, or nickel alloy wire). The guiding element may be constituted by natural fibres such as cotton or animal products. The guiding element may be made of a polymer such as a biodegradable polymer or comprise repeated lactic acidPolymers such as polylactic acid (PLA), of lactone or glycolic acid units. The guiding element may also be made of a material such as Tyvek ^TM (high density polyethylene fibers) or Kevlar ^TM (para-aramid fiber) and the like. In one embodiment, guide element 30 is formed from a vinyl such as available from Ethicon corporation of samavir, new jersey ^TM (polyglutamine) 910) suture.

In some embodiments, magnetic anastomosis device 16 may include a plurality of guide elements 30. For example, as shown in fig. 8A, 8B, 8C, 8D, 8E, and 8F, various attachment points may be used to provide control over the position and deployment of the self-assembled magnetic anastomosis device 16. As shown, four guide elements 30 (1) -30 (4) may be coupled to four separate portions of the device 16, respectively. Each guide element may include a distal end coupled to a corresponding portion of the anastomosis device and a proximal end that may be manipulated (i.e., increased or decreased in tension) once the anastomosis device is self-assembled into a predetermined shape (i.e., a polygon) thereby manipulating the positioning and orientation of the anastomosis device. For example, as shown, the guide element 30 (1) is coupled to the most distal portion, the guide elements 30 (2) and 30 (3) are coupled to the intermediate portion (the portion between the most distal portion and the most proximal portion), and the guide element 30 (4) is coupled to the most proximal portion.

Fig. 9-12 illustrate various methods of accessing a target site (specifically, accessing the gallbladder) via an endoscopic ultrasound-guided procedure. Fig. 9 illustrates the use of monopolar energy to pierce and access the gallbladder 11. An endoscopic ultrasound scope (EUS scope) 14 is positioned proximate to the stomach 10/duodenum 76. A thermal probe or guidewire of monopolar or bipolar energy is used to pierce the tissue of the stomach 10/duodenum 76 and gallbladder 11 for delivery of the anastomosis device 16.

Fig. 10 illustrates the use of a thin aspiration needle (FNA) to pierce and access the gallbladder 11.FNA 14 is located near the stomach 10/duodenum 76. A hypotube with a cutting edge pierces the tissue of the stomach 10/duodenum 76 and gallbladder 11 for delivery of the anastomosis device 16.

Fig. 11 illustrates the use of a helical needle 17 to pierce and access the gallbladder 11. The EUS mirror 14 is proximal to the stomach 10/duodenum 76. The cork screw 17 pierces the tissue of the stomach 10/duodenum 76 and gallbladder 11 for delivery of the anastomosis device 16.

Fig. 12 illustrates the use of the guidewire 14 through the bile duct 19. The guidewire 14 is proximal to the stomach 10/duodenum 76. The guidewire 14 pierces the tissue of the stomach 10/duodenum 76 and penetrates into the bile duct 19 for delivery of the anastomosis device 16 into the gallbladder 11.

Fig. 13 shows the EUS endoscope 14 with an access needle 28 that pierces the stomach 10/duodenum 76 and gallbladder 11 to access the interior of the gallbladder 11 for subsequent delivery of the magnet assembly 16 into the gallbladder 11.

Fig. 14, 15, 16 and 17 illustrate various means for anchoring the access device and/or delivery device to a target site at the gallbladder 11. Fig. 14 illustrates a T-bar member 304 tethered to the delivery device 14 by a tether 305, the member 304 serving as an anchor for bringing the tissues 22, 26 together.

Fig. 15 illustrates a preformed nitinol coil (e.g., "pigtail") 306 that serves as an anchor for bringing the tissues 22, 26 together.

Fig. 16 illustrates a balloon member of catheter 307 that serves as an anchoring device for bringing tissues 22, 26 together.

Fig. 17 illustrates a malvacot catheter 308 that serves as an anchoring device for bringing tissues 22, 26 together.

Fig. 18A-18F illustrate a method of accessing the gallbladder via endoscopic ultrasound guided access 14 and using an access device 27 that emits monopolar energy, anchoring delivery device 14 using a balloon catheter 307, and subsequently delivering a pair of magnetic anastomosis devices 16a, 16b into balloon 307 while balloon 307 is anchored within an intestinal incision formed between gallbladder tissue 26 and adjacent tissue 22 (i.e., stomach or duodenal tissue), thereby deploying devices 16a, 16b to both sides of the respective tissue 22, 26 (i.e., a first device within gallbladder 11 and a second device within stomach 10 or duodenum 76) to form an anastomosis therebetween.

Fig. 18A illustrates the EUS endoscope 14 in proximity to the stomach 10/duodenum 76 and the monopolar energy tip 27 penetrating the stomach/duodenum tissue 22 into the gallbladder tissue 26 for delivery of the anastomosis device 16 thereto.

Fig. 18B illustrates a cross-sectional view of the conveying device 15. Monopolar energy tip 27 pierces stomach/duodenal tissue 22 into gallbladder tissue 26. The device 15 is placed in an intestinal incision between tissues. Within delivery device 15, magnetic anastomosis devices 16a, 16b collapse within balloon catheter 307 within sheath 21 in the delivery device. The sheath 21 is later removed with the guide wire 23 and the balloon catheter 307 is stabilized in place.

Fig. 18C illustrates the sheath 21 being removed from the balloon catheter 307 to position and expand the catheter 307 within the intestinal incision.

Fig. 18D illustrates the sheath 21 completely removed and the balloon catheter 307 inflated through inflation line 25. The anastomosis device 16a, once pressed, expands within the lumen.

Fig. 18E illustrates a cross section of a fully inflated balloon catheter. The "doughnut" shaped balloon has a thin inner bore or channel 29 as an anastomosis for fluid and other materials to flow through.

Fig. 18F illustrates inflation of the fully deployed balloon catheter 307 through inflation line 25. When balloon catheter 307 is fully inflated, monopolar energy tip 27 is removed, leaving catheter 307 and anastomosis device 16.

Fig. 19 illustrates a variation of the design of fig. 18A-18F, particularly with the use of a balloon 307 to deliver a single magnetic anastomosis device 16a into the gallbladder 11, rather than a pair.

Fig. 20A-20C illustrate a method of accessing the gallbladder 11 via endoscopic ultrasound guided access 14 and using a heat insertion tube 27 that emits monopolar energy, followed by delivery of the magnetic anastomosis device 16 into the gallbladder 11 via the heat tube 27.

Fig. 20A illustrates the EUS speculum 14 approaching the stomach 10/duodenum 76 and approaching the gallbladder 11 with a hot insertion tube 27 for delivering the anastomosis device 16 thereto.

Fig. 20B illustrates activation of monopolar energy tip 75 to advance insertion tube 27 into gallbladder 11.

Fig. 20C illustrates the distal tip of the delivery device deploying magnetic anastomosis device 16 a.

Fig. 21A illustrates the EUS endoscope 14 approaching the stomach 10/duodenum 76 and approaching the gallbladder 11 with a hot insertion tube 27 for delivering the anastomosis device 16a thereto.

Fig. 21B illustrates the following method: access to the gallbladder via endoscopic ultrasound is provided to the access device 14 and with the access device 14 having a conductor 23 with a "hot" tip that emits monopolar energy 27, anchoring the delivery device with the use of a Marek's catheter 308, followed by the use of Marek's catheter 308 as a conduit for passing the magnetic anastomosis device 16 therethrough into the gallbladder 11 while the Marek's catheter 308 is anchored within an intestinal incision formed between the gallbladder tissue 26 and adjacent tissue 22 (i.e., stomach or duodenal tissue). The user pulls back on the access device 14 to cause the magnet 16 (fig. 21C) to open and advance the tip 27 (fig. 21D).

Fig. 21E illustrates that the magnetic anastomosis device 16 may be deployed through an end of the access device 104 or through a window in the catheter 106. In some embodiments, the window in the catheter 106 may be radiopaque in order to maintain proper orientation.

Fig. 22A to 22C illustrate variations of the process and apparatus illustrated in fig. 21A to 21E. Fig. 22A illustrates magnetic anastomosis device 16a preloaded into the distal end of marlecite catheter 308 of delivery device 14, wherein suture 31 secures magnet 16a within delivery device 308.

Fig. 22B illustrates how the user pulls back on suture 31 when marlecote end 308 is transitioned to the anchoring position, resulting in delivery and deployment of device 16 a.

Fig. 22C illustrates how pushing the delivery device 308 forward cuts the suture 31 in the window of the marlecite catheter 308.

Fig. 23 illustrates a marceous catheter 308 with a distal end extending to an anchoring position on one side of the cholecyst tissue wall 26.

Fig. 24 illustrates a marlecite catheter 308 distally expanded to an anchoring position on either side of the cholecyst tissue wall 26. In both cases, a temporary Marek's catheter 308 may be deployed inside the gallbladder 11 to form a temporary conduit, allowing drainage to occur immediately, and may further allow the gallbladder to be inflated. It should be noted that any embodiment providing a channel from the gastrointestinal tract into the gallbladder (marlecite, heat pipe, nitinol coil, balloon, etc.), in particular any device creating a channel for the magnetic anastomosis device to pass through, may also be used as a drainage channel. More specifically, after the access channel has been created, any substance fluid within the gallbladder may be evacuated (either by itself or under suction) prior to the onset of delivery of the magnetic anastomosis device. The channel may also be used to push fluid into the gallbladder (possibly with multiple fill/drain cycles) prior to draining from the gallbladder in order to "clean out" the gallbladder in the event of excess liquid and contents (i.e., bile or other contents) within the gallbladder.

Fig. 25A-25E illustrate a method of accessing the gallbladder 11 via an endoscopic ultrasound guided access needle 14 and anchoring the delivery device 100 by use of a T-bar assembly 304. As shown in fig. 25B, the T-bar 304 is anchored within an intestinal incision formed between the gallbladder tissue 26 and adjacent tissue 22 (i.e., stomach or duodenal tissue) and is tied 305 to the gallbladder wall 26.

Fig. 25C illustrates a stabilizer member 309. The stabilizer member 309 is advanced to the wall of the duodenum 76 or stomach 10 for traction. Deployment sheath 21 is then advanced into gallbladder 11, as shown in fig. 25D, at which point magnetic anastomosis device 16a may be delivered. In some embodiments, the system may be rotated to facilitate deployment of magnetic anastomosis device 16.

Fig. 25E illustrates a fully formed magnet anastomosis device 16a surrounding a T-bar 304. In some embodiments, the T-bar 304 is metallic and may be attracted to and adhere to the magnet 16a.

Fig. 26A to 26C illustrate modified forms of the process and apparatus illustrated in fig. 25A to 25E. Fig. 26A illustrates that the deployment sheath 21 includes a notch 32 on its distal end configured to engage the T-bar 304 when advanced through an intestinal incision. Fig. 26B illustrates that the notch 32 in the deployment sheath 21 pushes the T-bar 304 to one side that allows for subsequent delivery and deployment of the magnetic anastomosis device 16. Fig. 26C illustrates deployment of magnetic anastomosis device 16 with T-bar 304 pushed to that side.

Fig. 27A-27C illustrate another variation of the procedure and device illustrated in fig. 25A-25E, wherein the assembly of fig. 27A-27C relies on placement of the T-bars 304 through the access needle 28 rather than including a deployment sheath for delivering the self-assembled magnetic anastomosis device 16 as previously described herein, such that a set of T-bars 304 are configured to self-assemble into an array and serve as a distal anastomosis device to correspondingly mate with a proximal magnetic anastomosis device 16b disposed on the other side to subsequently squeeze tissue 22, 26 therebetween to form an anastomosis.

Fig. 27A illustrates delivery of the T-bar 304 assembly through the access needle 28. In some embodiments, the T-bar 304 is magnetic. By pulling back on the delivery device 14, the user can deploy the T-bar 304 into the lumen. The T-bar 304 is secured in place by the suture 31.

Fig. 27B illustrates a fully deployed T-bar 304 magnet array. In this embodiment, the T-bar 304 is magnetic and is configured to be drawn toward the proximal anastomosis device 16b. By pulling on suture 31, the user can bring the array of T-bars 304 to proximal anastomosis device 16b in order to create an anastomosis therein.

Fig. 27C illustrates an array of T-bars 304 and suture 31 linearly loaded into access needle 28. The linear loading of the T-bar 304 allows for minimally invasive creation of anastomosis. Because the magnetic assembly is loaded linearly and then self-assembled, the resulting anastomotic aspect ratio may be greater than 1:1 when the magnetic assembly is assembled to a size greater than the proximal needle diameter. This allows for creating a larger anastomosis while still maintaining a minimally invasive procedure.

Fig. 28A-28C illustrate a method of accessing the gallbladder 11 via an endoscopic ultrasound-guided access needle access 14 using a side port deployment sheath 106 for delivering and deploying a pair of magnetic anastomosis devices 16.

Fig. 28A illustrates a method of accessing the gallbladder 11 for deployment of the distal magnetic anastomosis device 16 a. The delivery device 15 approaches the stomach 10/duodenum 76 and pierces through the stomach tissue wall 22 into the gallbladder 11. The delivery device 15 in this embodiment has a side port 106 for deploying the proximal magnetic anastomosis device 16 b.

Fig. 28B illustrates a spin ring 50 with a metal insert 51 according to some embodiments of the invention. The rotating ring 50 is rotatable about the axis of the conveyor. When the magnetic device 16 is deployed from the side port 106 of the delivery device 14, the metal insert 51 on the rotating ring 50 grabs the magnetic device 16 and directs the magnet 16 away from the delivery device 14 about the axis of the delivery device 14 to facilitate self-assembly of the magnetic anastomosis device 16. In some embodiments, the spin ring 50 may spin freely or may spin as the magnet 16 is pushed out of the delivery device 14. In some embodiments, the spin ring 50 may actively rotate to pull the magnetic device 16 out of the delivery device 14.

Fig. 28C is a close-up view of the rotating ring 50 on the shaft of the conveyor 15. In some embodiments, the spin ring 50 may be made of metal.

29A-29C illustrate a knotting element 52 configured to secure a magnetic anastomosis device 16, which has been deployed and positioned, to a target site tissue and then cut a guide element 30 or suture 31 coupled thereto. As shown in FIG. 29A, knotting element 52 is pushed over guide element 30 within the working channel of the speculum. The guiding element is arranged to pass through the patient to the stomach 10 and is connected to an anastomotic device 16 pre-positioned in the gallbladder 11 and the stomach 10.

Fig. 29B illustrates knotting element 52 advanced toward magnetic anastomosis device 16, wherein knotting element 52 is generally comprised of outer tube member 53 and inner rod member 54 such that upon reaching the device, inner rod member 54 may be pressed toward the distal end of outer tube member 53, thereby securing a portion of guide element 30 therebetween and further cutting/severing guide element 30 in the process.

FIG. 29C illustrates knotting element 52 fully advanced to magnetic anastomosis devices 16a, 16b, thereby securing guide element 30 and further cutting guide element 30.

Fig. 30A to 30D illustrate the following method: access to the gallbladder 11 via an endoscopic ultrasound guided access needle 14 and delivery of a magnetic coil 53 or ring configured to transition from a generally linear shape to a generally annular shape upon delivery into the gallbladder 11 and configured to correspondingly cooperate as a distal anastomosis device with a proximal magnetic anastomosis device 16b disposed on the other side to subsequently squeeze tissue 22, 26 therebetween to form an anastomosis.

Fig. 30A illustrates delivery device 14 approaching stomach 10 and deploying a magnetic coil 53 or ring into gallbladder 11 through stomach tissue wall 22 to serve as a distal anastomosis device.

Fig. 30B illustrates a close-up view of the magnetic coil 53 or ring in a ring-shaped and straight position. The magnetic device 53 is loaded into the conveyor 14 in a linear position. Once deployed, the magnetic device 53 self-assembles into a coil or loop for use as a distal magnetic anastomosis device. In some embodiments, the coil is a laser cut hypotube, allowing the magnetic device 53 to bend/flex.

Fig. 30C illustrates the hypotube magnetic device 53 deployed into the distal lumen 70 via a nitinol or pigtail wire 306. Nitinol wire 306 pierces stomach tissue wall 22 into gallbladder 11 to deliver a distal anastomosis device, which in this embodiment is magnetic hypotube 53.

Fig. 30D illustrates proximal magnet 16b mated with magnetic hypotube anastomosis device 53. Once deployed, hypotube 53 self-assembles into an annular shape. Due to the corresponding polarities in proximal magnet 16b and distal magnet 53, the magnets engage and squeeze tissue 22, 26 therebetween, thereby forming an anastomosis.

Fig. 31A illustrates a collection of magnetic portions 202 pre-packaged with unstable polarity, including a plurality of guide elements 30, tethers, or sutures that interconnect adjacent portions to facilitate self-assembly of the magnetic portions 202 into a polygonal deployment shape.

Fig. 31B illustrates a self-assembled magnetic anastomosis device. After deployment from delivery device 14, magnetic anastomosis device 16 self-assembles into a polygonal shape. These magnetic portions 200 are held in a polygonal deployment shape by the guide element 30, tether or suture.

Fig. 32A and 32B illustrate a method of accessing the gallbladder 11 via endoscopic ultrasound guidance through the stomach 10/duodenum 76 into the gallbladder 14 and using an access device having a conductor with a "hot" tip that emits monopolar energy 27, and then delivering the pre-packaged magnetic portion of fig. 31A-31B into the gallbladder 11 through the sheath 21.

Fig. 32A illustrates the EUS endoscope 14 being guided into the stomach 10. The endoscopic deployment uses monopolar energy to pierce the tissue 22 of the stomach 10 into the gallbladder 11 and deliver the magnetic anastomosis device 16a to the "hot" tip 27 thereof.

FIG. 32B illustrates a close-up of the "hot" tip deployment mechanism. The "hot" tip 27, using monopolar energy, pierces the stomach tissue 22 into the gallbladder 11. The distal magnet 16a, the separator 54 between the magnets, and the proximal magnet 16b are loaded into the sheath 21. Distal magnet 16a is deployed into distal lumen 70 for self-assembly by the user pulling delivery device 14 rearward.

Fig. 33A-33C illustrate a method of ultrasonically guiding an access 14 via an endoscope and into the gallbladder 11 with a needle 28 to access the gallbladder 11 and then delivering a coiled stack of magnetic portions 202 configured to act as a distal anastomosis device to correspondingly cooperate with a proximal magnetic anastomosis device 16b disposed on the other side to subsequently squeeze tissue 22, 26 therebetween to form an anastomosis. As shown in fig. 33A, the nitinol coil 306 is advanced into the gallbladder 11.

Fig. 33B illustrates how the magnetic portion 202 is then advanced around the extended nitinol coil 306.

Fig. 33C illustrates how the magnetic portions 202 collapse upon each other (due to magnetic attraction) after pulling the suture 31 and form a coiled stack of magnets 202 after removal of the nitinol coil 306.

Fig. 34A-34B illustrate a method of ultrasonically guiding an access 14 via an endoscope and using a needle into the gallbladder 11 to access the gallbladder 11 and subsequently delivering a magnetic fluid or suspension of magnetic particles 55 into the gallbladder 11, the magnetic particles 55 being configured to act as a distal anastomosis device correspondingly mated with a proximal magnetic anastomosis device 16B disposed on the other side to subsequently squeeze tissue 22, 26 therebetween to form an anastomosis.

Fig. 34A shows the EUS speculum 14 in proximity to the stomach 10. An access needle 28 with piercing capability pierces stomach tissue into the gallbladder 11 to deliver magnetic fluid or particles 55 into the distal lumen.

Fig. 34B illustrates that when proximal magnet 16B is approached, magnetic particles 55 will be attracted to proximal magnet 16B, squeezing tissue 22, 26 therebetween and therein to form an anastomosis.

Fig. 35 illustrates a magnetic anastomosis device including a continuous guide element 30 or suture 31 coupled to a plurality of magnetic portions 16 of the device through eyelets provided on each of the plurality of magnetic portions. The magnets 16 have perforations 59 on the inner circumference to prevent the suture from being caught or pinched between the magnets. Suture 31 extends through eyelet 59 and has legs 56, 57, 58, which a user may individually or simultaneously pull on legs 56, 57, 58 to manipulate magnet 16. The legs 56 or 58 may be pulled individually to remove the suture 31.

FIG. 36 illustrates one embodiment of a suture cutting arrangement within a deployment sheath of a delivery device or within an auxiliary device for cutting a suture coupled to a magnetic anastomosis device.

Fig. 37A and 37B are enlarged side views illustrating an anvil/tip arrangement and a tip/tip arrangement for cutting a suture.

Fig. 37A illustrates a deployment sheath that utilizes a push/pull cutting method to bring together the anvil 61/tip 60 system to cut the suture 31. The blade is exposed by pushing on deployment sheath 21 and pulling on suture 31 introduces tension on suture 31. The tensioned suture 31 is then pulled through the sharp edge 60 and cut.

Fig. 37B illustrates a tip 60/tip 60 system in which the blade is exposed by pushing on the deployment sheath 21 and pulling on the suture 31 introduces tension on the suture 31. The tensioned suture 31 is then pulled through the sharp edge 60 and cut.

Fig. 38 illustrates a loop breaker device 62 (auxiliary device) inserted through the working channel, configured to be inserted over the guide element 30 or suture 31 coupled with the magnetic anastomosis device 16 and configured to cut the guide element or suture once it has been deployed and positioned at the target site.

Fig. 39A illustrates a loop breaker device 62 including a resistive heating element for cutting the guide element. The loop breaker device 62 is guided through a support tube of the access device 14. Once the loop breaker 62 is deployed in place over the suture 31, the loop breaker 62 is pulled back and energy is applied to sever the suture 31. The applied energy may be a low voltage from a battery or a generator.

Fig. 39B illustrates a loop breaker device 62 disposed outside of the speculum 14 or encased in a cap, within a loop breaker sleeve 63 and advanced into the stomach 10. By pulling back the endoscope 14, the loop breaker device 62 is advanced over the suture 31 attached to the deployed magnet 16 by the deployment device 64 and cuts the suture.

Fig. 39C illustrates a cross section of a loop breaker device 62 including a loop member 65 having a cutting edge for cutting the suture 31. By pulling back the loop breaker sleeve 63, the loop 65 with the cutting edge cuts the suture 31.

Fig. 39D illustrates an auxiliary device configured to provide suture or guide element cutting with monopolar/bipolar energy. Monopolar tip 27 is advanced toward tissue 22 and cuts suture 31 attached to deployed magnetic anastomosis device 16.

Fig. 40 illustrates the guide element or suture 31 separated. In an embodiment, the suture has a necked down or weakened area 66. By pulling back the sutures 31 they will separate from the deployed anastomosis device 16.

Fig. 41A and 41B illustrate a removable suture assembly. Within the sheath 21, there is a constrained over-molded driver 67 attached to the suture 31. The driver 67 may be staggered within the sheath 21 as shown in fig. 41A, or may be located in a separate lumen. By removing the sheath 21, the overmold driver 67 is no longer constrained and separated, as seen in fig. 41B.

Thus, the exemplary embodiments provide improved devices and techniques for minimally invasive anastomosis formation in vivo (e.g., within the gastrointestinal tract). Such devices and techniques facilitate faster and cheaper treatment of chronic diseases such as obesity and diabetes. This technique also reduces the time and pain associated with palliative treatment for diseases such as gastric or colon cancer. More specifically, the exemplary embodiments provide systems, devices, and methods for delivering, deploying, and positioning a magnetic pressing device at a desired site to improve the accuracy of creating an anastomosis between tissues, organs, and the like.

Fig. 42 illustrates a perspective view of another embodiment of a magnetic assembly 200 according to the present disclosure. The magnetic assembly 200 includes a pair of magnetic portions 202, 204 arranged in generally linear alignment with each other (e.g., aligned in an end-to-end fashion) and coupled together via a flexible exoskeleton element 206. Portions 202, 204 are spaced apart via middle portion 108 of exoskeleton 206. The middle portion 208 may include a connection member for receiving a corresponding connection member of a deployment device to facilitate transport of the magnetic assembly 200, as will be described in greater detail herein. The exoskeleton may be made of an elastic material such as a polymer or metal alloy that retains its shape after deformation. In some embodiments, the metal alloy will include nickel such as nitinol. Exemplary exoskeleton embodiments are described in U.S. patent No.8,870,898, U.S. patent No.8,870,899, and U.S. patent No.9,763,664, the contents of each of which are incorporated by reference herein in their entirety.

The magnetic assembly 200 is configured to be delivered and deployed to a target site via the delivery device 100. As previously described, the exemplary embodiments provide improved devices and techniques for minimally invasive anastomosis formation in vivo (e.g., within the gastrointestinal tract). Such devices and techniques facilitate faster and cheaper treatment of chronic diseases such as obesity and diabetes. This technique also reduces the time and pain associated with palliative treatment for diseases such as cancer (such as gastric or colon cancer). More specifically, the exemplary embodiment provides a system including a delivery device 100 for introducing and delivering a pair of magnetic assemblies between adjacent organs via minimally invasive techniques to bridge tissue walls of each organ together, thereby forming a passageway (i.e., anastomosis) therebetween. The delivery device 100 is particularly useful for delivering the pair of magnet assemblies to a target site within the gastrointestinal tract to thereby form an anastomosis between the stomach wall and the gallbladder wall to provide adequate drainage from the gallbladder when an occlusion (due to disease or other health-related problems) is occurring.

Fig. 43A-43I illustrate various steps of deploying a pair of magnet assemblies 200a, 200b to a target site for subsequent anastomosis. In the embodiments described herein, the system generally includes a speculum 14, such as an endoscope, laparoscope, catheter, trocar, or other access device, through which a delivery device is advanced to a target site to deliver and position a pair of magnet assemblies 200a, 200b for subsequent anastomosis at the target site. In particular, the delivery device 100 includes an elongate hollow body 102, such as a catheter, shaped and/or sized to fit within a speculum. The conveyor includes a working channel in which a pair of magnet assemblies 200a, 200b are mounted. The delivery device also includes a distal end 104 configured to pierce or otherwise penetrate tissue.

For example, fig. 43A illustrates advancement of the distal tip of delivery device 100 through the respective tissue walls of adjacent organs at a target site to subsequently form an anastomosis therebetween. For example, the distal end 104 may have a sharp tip for piercing tissue and/or may penetrate tissue with energy (i.e., a thermal tip). The body 102 of the delivery device 100 also includes a slot or opening 106 adjacent the distal end 104, as shown in fig. 43B. As shown, the slot 106 extends completely through one side of the body 102 of the delivery device 100. The slot 106 is shaped and/or sized to receive the magnetic assemblies 200a, 200b therethrough such that the magnetic assemblies 200a, 200b pass through the working channel and exit the delivery device 100 via the slot 106. The delivery device 100 also includes a deployment member 108, typically in the form of a wire or the like, releasably coupled to one or both of the magnetic assemblies 200a, 200b and providing a means/means of deploying the magnetic assemblies 200a, 200b from the distal end of the delivery device 100 via the slot 106.

During surgery, a surgeon or other trained medical professional may advance the endoscope 14 (e.g., an endoscope) within the hollow body of the patient and position the endoscope 14 at a desired anatomical location for forming an anastomosis based on visual depictions of the target site location provided by the imaging device 18 that provides a medical imaging procedure (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 distal tip 104 of delivery device 100 through the adjacent walls of a pair of organs (i.e., through the wall of duodenum 11 and the wall of common bile duct 19) in any of the manners previously described herein. After advancing distal end 104, including slot 106, into the first organ (i.e., the common bile duct), the surgeon may manually deliver and deploy first magnet assembly 200a into the first organ via the slot using deployment member 108. For example, fig. 43C illustrates the delivery of the first magnet assembly 200a into the common bile duct. As shown, the deployment member 108 includes a connection member 110 at a distal end of the deployment member 108 that is configured to releasably couple to a corresponding connection member (indicated by attachment point 113) of a middle portion 208 of the exoskeleton 206. As the deployment member 108 is advanced and extended toward the distal end 104 of the delivery device 100, the first magnetic assembly 200a passes from the working channel of the delivery device 100 through the slot 106 to transition to the deployed state, as illustrated in fig. 43D. As shown, deployment of the first magnetic assembly 200a results in a pair of magnetic portions 202, 204 exiting the slot 106 on opposite respective sides of the body 102 of the delivery device 100, while a central portion 208 of the exoskeleton 206 remains within the slot 106. In other words, the slot 106 extends completely through the body 102 of the delivery device 100 from side to side. Thus, when in the deployed state, the first magnet assembly 200a is positioned into the first organ while remaining retained within the slot 106 of the delivery device 100.

At this point, the surgeon need only pull back on delivery device 100 until first magnetic assembly 200a engages the tissue of the first organ and a majority of slot 106 is positioned within the second organ. The surgeon can then deliver and deploy the second magnet assembly 200b into the second organ (i.e., the duodenum). Fig. 43E illustrates the first magnetic assembly 200a fully deployed within the first organ and the delivery device 100 pulled back, thereby pulling 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 in the duodenum.

The second magnetic assembly 200b is deployed in a similar manner to the first magnetic assembly 200a, with the magnetic portions 202, 204 of the second magnetic assembly 200b exiting the slot 106 on opposite respective 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 magnet assembly 200b into the duodenum. Fig. 43G is an enlarged view of a partial cross-section of second magnetic assembly 200b advanced to a deployed state. As shown, as the second magnetic assembly 200b is advanced through the working channel toward the slot 106, the assembly 200b is configured to engage the angled portion 112 of the routing member, which helps guide at least one portion of the assembly 200b into position as shown. Fig. 43H illustrates the first and second magnetic assemblies 200a, 200b in a fully deployed state. The first and second magnetic assemblies 200a and 200b are substantially aligned with each other and the first and second magnetic assemblies 200a and 200b will be coupled with each other due to magnetic attraction.

As shown in fig. 43I, the distal end 104 of the delivery device 100 includes two halves that form a relatively uniform tip shape when in a default state. However, the distal end includes a deformable material (i.e., shape memory material) such that upon application of sufficient force, the two halves will separate. In this way, once both the first and second magnetic assemblies 200a, 200b have been delivered and effectively coupled to one another (but remain within the slot 106), the surgeon need only pull back the delivery device 100, which then brings the magnetic assemblies 200a, 200b into contact with the distal end 104 and forces the two halves of the distal end 104 apart, 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. A pair of magnet assemblies 200a, 200b squeeze the walls of each respective organ therebetween, thereby subsequently forming an anastomosis between the organs (i.e., an anastomosis between the duodenum and common bile duct).

After deployment, each magnetic assembly has a width and length that generally corresponds to the width of the respective portion and a length that is approximately twice the length of each portion. As a result, the pair of magnetic assemblies, when coupled to each other, generally form a substantially linear enclosure, and the resulting anastomosed shape formed may be generally rectangular, but may of course form a circular or oval shape. The resulting anastomosis may have an aspect ratio of 1:1 relative to the size of the magnetic assembly. However, the exemplary embodiments allow for a greater aspect ratio (i.e., a greater anastomosis with respect to the size of the magnetic assembly). In particular, prior art systems and methods involving the use of magnets to create anastomosis are generally limited based on the size of the working channel of the endoscope or catheter used to deliver such magnets, which in turn limits the resulting size of the anastomosis. The magnetic assembly design overcomes such limitations.

For example, the design of the magnetic assembly, particularly via the exoskeleton, to interconnect the magnetic portions allows for any number of portions to be included in a single assembly, and thus the resulting anastomosis has a larger size relative to the size of the working channel of the speculum. For example, in some embodiments, the resulting anastomosis may include an aspect ratio in the range of 2:1 to 10:1 or greater.

Fig. 44A-44D are cross-sectional views of various contours of a magnet portion of a magnet assembly within a working channel of a standard speculum. The cross-sectional area of the magnet is illustrated, which exhibits a polygonal shape as well as elliptical and circular shapes, accounting for 10% to 95% of the annular space of the working channel. With the guidelines for magnetic profiles in place, the next constraint on the device is the minimum 6:1 and maximum 50:1 axial ratio. The length of the segments, once assembled in the body, may have a regular or irregular shape.

FIG. 45 provides a list of some exemplary working channel sizes that are considered to be usable/feasible for deploying a magnetic array with a cage to produce anastomosis. These sizes do not limit future capabilities because the scope channel size increases/decreases with market and device changes. For a device designed to be about 3.7mm in a particular size, a summary of the determined size can be generalized to: 1.0mm-6.0mm (including a hemorrhagic mirror called "clot kern").

Thus, the delivery device of the present disclosure produces a low profile linear anastomosis, which will allow for relief of certain complications, particularly those associated with common bile duct blockage. In particular, patients experiencing common bile duct blockage often undergo some procedure to remove the blockage or allow drainage to provide relief from jaundice/infection and portal complications. A common procedure is a sphincterotomy or some sort of drainage stent deployment procedure. There are procedures that perform bile duct decompression in a conventional manner but are not possible to perform in a minimally invasive manner. Such procedures include, for example, sphincterotomies, which are not possible due to the inability to intubate the common bile duct (especially in severe diseased conditions where anatomic variations cannot be considered). Using a magnetic closure force profile as described herein will allow minimal bleeding and form a semi-permanent slit profile. This slit profile will help to resist "sump syndrome" and to create a drainage point that will effectively remain free of infection.

Another concept includes medical devices designed for users who need more efficient means to create openings between circular staples or press fit devices, thus creating or expanding an intestinal incision. Certain embodiments will fit into existing channels of endoscopes or other delivery devices such as laparoscopes or catheters and provide effective tissue inactivation, allowing nutrients to pass through or tissue inactivation. Current methods are time consuming, ineffective and often life threatening. The device provides an effective alternative that makes the procedure faster, safer, easier, and more cost-effective. The product provides a simple solution to the potentially life threatening problem, including the ability to decompress the organ or immediately allow nutrient bypass.

The concept encompasses different embodiments of a mechanism/tool for creating an intestinal incision between magnetic expression devices (e.g., via cutting, dissection, dilation, cautery, etc.). The mechanism/tool can be delivered to the target site via an existing channel of an endoscope or delivery device used to deliver or deploy the magnetic expression device. Embodiments include a deployable cutting mechanism that includes a mechanism (i.e., a hot needle or electrode) for physically shearing tissue or cauterizing and inactivating tissue with energy. Certain exemplary embodiments include a helical member (e.g., a needle) attached to the end of a rotatable catheter and a coring needle or hot needle to be used in conjunction with the helical member. In particular, the helical member may be rotated while piercing the tissue, thereby pulling the catheter toward the tissue wall. Once the catheter tip is at a sufficient depth, a coring needle or hot needle may be engaged and advanced into the tissue to create an intestinal incision.

Exemplary embodiments include an apparatus having the ability to independently cut, dissect, dilate and cauterize tissue or in combination with other methods between one or more cooperating devices (e.g., press anastomosis devices) that create and/or capture an open conduit for pressing or depressurizing or nutrient bypass, for example, while remaining concentric with a deployment channel.

Exemplary embodiments also include apparatus having the ability to be delivered into an adjacent wall that can then be used as a conduit to deliver a press anastomosis device.

Exemplary embodiments also include apparatus that allow for shearing, expanding or resecting tissue between one or more pressing devices.

Exemplary embodiments also include devices having retractable sharp tips or energy to provide tissue inactivation.

In some embodiments, there may be two exemplary cutting mechanisms, specifically a cap configured to "cut" tissue (e.g., including edges or grooves to cut tissue using energy mechanical cutting) and a press device having a cutting mechanism that may be used to capture and cut tissue with or without the cap.

Fig. 46 is a schematic diagram illustrating two exemplary cutting mechanisms, specifically a mechanical cutting mechanism 68 and an electronic cutting mechanism 27 (e.g., tissue inactivation using RF or electrode/heat between one or more inactivation devices).

Certain exemplary embodiments use a helical needle at the end of a torsionally/rotatably-configured catheter, which can be advanced into the lumen wall and then screwed into the wall to a depth. Because of the helical action, the user will have better control over how deep the end of the catheter will advance in the tissue. Once the catheter tip is at a sufficient depth, the second member can be engaged and advanced. This may be a coring needle (fig. 47) or a hot needle (fig. 48). When engaged, the second member will drive into tissue captured within the helical member and the total distance the second member can travel will be limited such that the second member cannot advance beyond the distal end of the helical member. The embedded helical member will provide a reaction force to the forward drive of the second member and the helical member may cover the second member so that it does not damage any tissue beyond the depth of engagement of the helical member (i.e., the opposing walls of the distal lumen).

FIG. 47 is a schematic diagram illustrating a coring needle device in accordance with an exemplary embodiment. Fig. 47 (a) shows a helical member rigidly attached to the rotatable catheter end. The distal tip of the helical member is a needle tip so that it can be "screwed" into tissue. Fig. 47 (B) shows the coring needle residing within the catheter prior to catheter advancement. Fig. 47 (C) shows the advancement of the coring needle through the tissue enclosed within the helical member. The helical member provides a reaction force to the pushing so that the tissue does not recede. In certain exemplary embodiments, the coring needle is limited to advance no more than the distal end of the helical member to keep the needle tip covered, as depicted in fig. 47 (D).

Fig. 48 is a schematic diagram illustrating a thermal needle device according to an example embodiment. Fig. 48 (a) shows a helical member rigidly attached to the rotatable catheter end. The distal tip of the helical member is a needle tip so that it can be "screwed" into tissue. Fig. 48 (B) shows the hot needle residing within the catheter until it is advanced. Fig. 48 (C) shows the hot needle advanced into the tissue enclosed within the helical member, but is limited to being unable to advance beyond the distal edge of the helical member. Fig. 48 (D) shows the application of electrosurgical energy through the needle, thereby dehydrating and damaging the target tissue. In both cases, once the second member is advanced, it can be retracted and the helical member can be pulled free (as the tissue has been cored or dehydrated).

Control member

Fig. 49, 50, 54A, 54B, 55A, 55B, 56A, 56B, 57A, 57B, and 58 illustrate various exemplary embodiments of mechanisms/tools for creating an intestinal incision between press anastomosis devices. The mechanism/tool is deployed through the channel of an endoscope or delivery device, and then the press fit device in the proximal lumen is captured and centered. The device utilizes a penetrating tip to create an intestinal incision between lumens that is axially aligned with the delivery channel. The penetrating tip support serves as a guide for transluminally deploying the press anastomosis device and control member into the distal lumen. The control member may comprise an array of at least one arm/member that manipulates a connecting member (i.e., suture) connected to a distally deployed press device. The control member may be pressed to a diameter smaller than the bowel incision, deployed into the distal lumen, and expanded to a diameter larger than the bowel incision to increase control of the connecting member and expand the bowel incision. The press device may be pulled against the control member using the connecting member, with its mating axis aligned with the deployment channel by rotational movement, and mated with the press device within the proximal lumen by translational movement; the intestinal incision is captured. After engagement with the expression device, the control member may be expressed to a diameter smaller than the diameter of the intestinal incision and retracted into the working channel with the penetrating tip, thereby releasing the connecting member and leaving the engaged expression anastomosis device in place. Such devices may use, among other things, a monopolar or bipolar energized hot tip, a penetrating tip (which may be heated), or a cutting mechanism (e.g., a mechanical cutting mechanism, an RF/ultrasonic cutting mechanism, a heated cutting mechanism, etc.). A coring needle or other delivery mechanism may be used to help position and secure the piercing or cutting mechanism to the tissue.

Thus, certain exemplary embodiments include an apparatus having the ability to deliver a control mechanism comprised of an array of at least one articulating member into an adjacent lumen, the control mechanism extending to a larger diameter than the created intestinal incision, in order to increase the mechanical advantage/gain for controlling the connecting member attached to the distally deployed press anastomosis device. The increased diameter of the control mechanism may also be used as a tool to dilate and/or expand the intestinal incision made.

Other exemplary embodiments include apparatus that allow the use of a connecting member to control and manipulate the press device in the distal lumen to create an alignment within 15 ° between the deployment channel axis and the mating axis of the press device. The control mechanism allows movement in distal, proximal and rotational directions and can couple and decouple cooperating press anastomosis devices.

Additional exemplary embodiments include an apparatus having a biased sharpened cutting tip or monopolar or bipolar activation tip to provide tissue inactivation to form an intestinal incision centered coaxially with the working channel of the delivery device. The support of the tip serves as a guide for deploying the control member and the press anastomosis device into the distal lumen so as to wrap it over the support in a prescribed manner to orient and present the press device after deployment. In some configurations, the tip may also be used as a control member (i.e., an energized basket) and/or to dilate an intestinal incision formed.

Another concept includes an expandable/contractible mechanism configured to help control and manipulate the distal stapling device within the distal lumen, for example, when the delivery device is retracted into the proximal lumen to deploy the proximal stapling device, and also to help position/align the distal stapling device to properly couple with the proximal stapling device when the two stapling devices are brought closer together.

Fig. 49 illustrates deployment of an anastomosis device. After deployment of the proximal magnet 16B (fig. 49 (a)), the penetrating tip of the delivery device 100 pierces the lumen wall into the distal lumen 70, creating an intestinal incision (fig. 49 (B)). By pulling the delivery device 100 back, the distal magnet 16a is deployed (fig. 49 (C)) and self-assembled (fig. 49 (D)). By continuing to pull back the delivery device 100, the control member 302 is deployed in the space between the lumens in the created intestinal incision (fig. 49 (D)). In some embodiments, as depicted in fig. 59, the control member is basket-shaped. The control member 302 expands to a diameter larger than that of the intestinal incision, thereby expanding the intestinal incision ((E) of fig. 49). The control member engages the distal magnet 16a and facilitates alignment with the proximal magnet 16b (fig. 49 (F)). The control member 302 also adds additional mechanical advantage/gain to the distal magnet 16a for bringing the two anastomosis devices 16a, 16b together. The two magnets 16a, 16b are brought together by the magnetic attraction force and the additional force of the control member 302. The user further pulls back the delivery device 100 and the control member 302 contracts to a smaller diameter than the intestinal incision (fig. 49 (G)) and retracts into the delivery device 100 (fig. 49 (H), (I)). The delivery device 100 and control member 302 can then be removed from the intestinal incision and the patient.

Fig. 50 illustrates various embodiments of a piercing tip on a distal end of a delivery device for creating an intestinal incision. Fig. 50 (a) illustrates a monopolar or bipolar energy hot tip 27 for inactivating tissue and thereby forming an intestinal incision. Once the proximal magnet 16b is deployed, the user can advance the delivery device against the target tissue wall. Activation of the energy at the distal end of the delivery device 100 allows monopolar or bipolar energy to deactivate tissue, thereby creating an intestinal incision between lumens. Tip 27 is advanced further into the distal lumen and the distal magnet is deployed by pulling back delivery device 100. Once deployed, the distal magnet aligns and mates with the proximal magnet due to magnetic attraction. By pulling the delivery device further back, the magnet remains in place to create an anastomosis, and the delivery device is removed from the intestinal incision and the patient.

Fig. 50 (B) illustrates a schematic diagram showing a coring needle apparatus, according to an exemplary embodiment. The upper row of fig. 50 (B) shows that the helical member 72 is rigidly attached to the end of the rotatable conduit. The distal tip of the helical member 72 is a needle tip so that it can be "screwed" into tissue. The coring needle 73 resides within the catheter until it is advanced. A coring needle 73 advanced through the tissue is enclosed within the helical member 72. The helical member 72 provides a reaction to the pushing so that the tissue does not recede. In certain exemplary embodiments, the coring needle 73 is limited to advance no further than the distal end of the helical member to keep the needle tip covered. Fig. 50 (B) also shows a schematic diagram according to an exemplary embodiment, which shows the hot needle device in the lower row of fig. 50 (B). The helical member 72 is rigidly attached to the end of the rotatable conduit. The distal tip of the helical member 72 is a needle tip so that it can be "screwed" into tissue. The hot needle 74 resides within the catheter until it is advanced. Fig. 50 (B) shows the hot needle 74 advanced into the tissue enclosed within the helical member 72, but limited to being unable to advance beyond the distal edge of the helical member 72. Electrosurgical energy is applied through the needle 74, thereby dehydrating and damaging the target tissue. In both cases, once the second member is advanced, it can be retracted and the helical member 72 can be pulled free (because the tissue has been cored or dehydrated).

Fig. 50 (C) illustrates a piercing tip 69 for creating an intestinal incision. The penetrating tip 69 is received within the delivery device 100 and advanced through the tissue wall, thereby inactivating the tissue and forming an intestinal incision. Once the intestinal incision is created, the distal tip of the delivery device 100 is advanced through the intestinal incision into the distal lumen. Once the delivery device 100 is positioned in the distal lumen 70, the user pulls back on the delivery device 100, deploying the distal magnet 16a. Fig. 50 (C) also depicts a drive-by-wire jaw control member 301. After deployment of the distal magnet 16a, the user pulls the delivery device 100 back and deploys the control member 301 into the intestinal incision. The control member 301 expands to a larger diameter than the intestinal incision, thereby expanding the intestinal incision. The control member 301 engages the distal magnet 16a and facilitates alignment with the proximal magnet 16 b. The control member 301 also adds additional mechanical advantage/gain to the distal magnet 16a for bringing the two anastomosis devices 16a, 16b together. The two magnets 16a, 16b are brought together by the magnetic attraction force and the additional force of the control member. The user pulls back the delivery device 100 further and the control member 301 collapses to a smaller diameter than the diameter of the intestinal incision and retracts into the delivery device 100 along with the piercing tip. The delivery device 100 and control member 301 may then be removed from the intestinal incision and subsequently from the patient.

Fig. 50 (D) illustrates RF or electrode 27 as a cutting mechanism for tissue inactivation between one or more inactivation devices. Fig. 50 (D) illustrates an exemplary cutting mechanism, specifically, a mechanical cutting mechanism and an electronic cutting mechanism 68 (e.g., tissue inactivation using RF or electrode/heat between one or more inactivation devices).

Fig. 51 illustrates three expandable/contractible control members provided for stop (backstop) control and manipulation of an anastomosis device, according to various exemplary embodiments. The configuration in a shows a basket stopper control member 302. Once the proximal and distal magnets 16b, 16a are deployed, the delivery device 100 is further advanced through the distal magnet 16a into the distal lumen 70. By pulling the delivery device 100 back, the control member 302 is deployed from the delivery device 100 to the contracted position. The user pulls the delivery device 100 rearward and the basket stop control member 302 expands to a diameter greater than the diameter of the distal magnet assembly 16 a. As shown in a of fig. 51, control member 302 engages distal magnet 16a to facilitate alignment of the magnetic assembly and provide additional mechanical advantage/gain to distal magnet 16a to mate the assembly through the tissue wall. Once the magnet assemblies 16a, 16b are mated, the control member 302 is retracted to a diameter smaller than the diameter of the magnet assembly and retracted into the delivery assembly 100 for removal from the patient.

The B configuration of fig. 51 shows the balloon stopper control member 303. Once the proximal and distal magnets 16b, 16a are deployed, the delivery device 100 is further advanced through the distal magnet 16a into the distal lumen 70. By pulling back the delivery device 100, the balloon stopper control member 303 is deployed to a contracted position that has been stored in the delivery device 100. The user pulls the delivery device 100 rearward and the balloon stopper control member 303 expands to a diameter greater than the diameter of the distal magnet assembly 16 a. As shown in B of fig. 51, the control member 303 engages the distal magnet 16a to facilitate alignment of the magnet assemblies 16a, 16B and to provide additional mechanical advantage/gain to the distal magnet 16a to mate the assemblies through the tissue wall. Once the magnet assembly is mated, the control member 303 is retracted to a diameter smaller than the diameter of the magnet assembly and retracted into the delivery device 100 for removal from the patient.

The C configuration of fig. 51 shows a "petal" stopper control member 301. The "petal" stop 301 works similarly to the other stops, in that once the proximal magnet 16b and distal magnet 16a are deployed, the delivery device 100 is further advanced past the distal magnet 16a into the distal lumen 70. By pulling back the delivery device 100, the control member 301 is deployed to a retracted position already stored in the delivery device 100. The user pulls back on the delivery device 100 so that the "petal" stopper control member 301 expands to a diameter greater than the diameter of the distal magnet assembly 16 a. As shown in fig. 51C, the control member 301 engages the distal magnet 16a to facilitate alignment of the magnet assemblies 16a, 16b and provide additional mechanical advantage/gain to the distal magnet 16a to mate the assemblies through the tissue wall. Once the magnet assemblies 16a, 16b are mated, the control member 301 is retracted to a diameter smaller than the diameter of the magnet device and retracted into the delivery device 100 for removal from the patient.

Of course, other control member configurations are possible based on the concept of an expandable/contractible stop (backstop).

Fig. 52 illustrates three expandable/contractible mechanisms provided for affirmative control and manipulation of an anastomosis device, in accordance with various exemplary embodiments. The a and C configurations show the wire basket control member 302. Configuration B shows a "petal" control member 301. The D configuration shows the tubular basket control member 302. Of course, other configurations are possible based on the concept of such control/manipulation and alignment mechanisms, such as, but not limited to, those shown in fig. 54A, 54B, 55A, 55B, 56A, 56B, 57A, 57B, and 58. Once the magnetic assembly is deployed, the user pulls back on the delivery device 100 to deploy the control member 302 into the intestinal incision between the lumens 70, 71, in the contracted position already stored in the delivery device 100. By pulling back on the delivery device 100, the user can expand the control member 302 to a diameter greater than the diameter of the intestinal incision, thereby expanding the intestinal incision. The control member 302 then engages the distal magnet 16a, manipulating it to align the two magnetic devices 16a, 16b. Once the devices 16a, 16b are aligned, the control member 302 may be used to add additional force to the distal magnet 16a in order to mate the two anastomosis devices across the tissue wall. Once the magnets are mated, the user pulls back the delivery device and the control member contracts to a diameter smaller than the diameter of the intestinal incision and retracts into the delivery device 100 for removal from the patient.

The mechanisms of the type shown in fig. 51, 52, 54A, 54B, 55A, 55B, 56A, 56B, 57A, 57B and 58 are configured to provide an alignment within 15 ° between the deployment channel axis and the mating axis of the press.

Fig. 54A, 54B, 55A and 55B illustrate another concept of an expandable/contractible mechanism configured to control and manipulate distal anastomosis device 16a within distal lumen 70 and configured in a wire-controlled jaw shape. Fig. 54A illustrates a front view of a wire-controlled jaw control member 301 being deployed. After deploying the proximal magnet 16b and the distal magnet 16a, the user pulls back the delivery device 100 to deploy the wire-controlled jaw control member 301. The control member 301, which has been in the contracted position stored in the delivery device 100, expands to a diameter larger than the diameter of the intestinal incision. The wire controlled jaw control member 301 engages the distal magnet 16a to manipulate and align the distal magnet 16a with the proximal magnet 16 b. Once the magnets 16a, 16b are aligned and mated, the user pulls back on the delivery device 100 to retract the control member of the drive-by-wire jaw to a smaller diameter than the intestinal incision and retracts the control member 301 into the delivery device 100 for removal from the patient.

FIG. 54B illustrates a side view of the control member deployment of FIG. 54A.

Fig. 55A illustrates a wire-controlled jaw control member 301 that manipulates a single magnet. In this embodiment, magnetic anastomosis device 16 is deployed into the lumen. Once deployed, the user pulls back on the delivery device 100 to deploy the wire-controlled jaw control member 301. The control member, which has been in the contracted position stored in the delivery device 100, expands to a diameter that is larger than the diameter of the magnet 16. The control member 301 engages a single magnetic device 16 to orient and position the magnets in the target area to form an anastomosis. Once the magnet is in the correct position, the user pulls back the delivery device 100 to retract the control member 301 to a diameter smaller than the diameter of the magnet 16 and retracts the control member 301 into the delivery device 100 for removal from the patient.

Fig. 55B depicts a side view of the control member deployment of fig. 55A.

Fig. 56A, 56B, 57A and 57B illustrate another concept of an expandable/contractible mechanism configured to control and manipulate a distal anastomosis device within a distal lumen and configured as a basket array.

FIG. 56A illustrates deployment of the basket array control member 302. Basket array control member 302 is deployed with distal anastomosis device 16a, with the distal end of control member 302 connected to distal anastomosis device 16a and the proximal end thereof attached to proximal anastomosis device 16b. The user pulls back on the delivery device 100, bringing the distal magnet 16a closer to the proximal magnet 16b. When the distal magnet 16a is directed toward the proximal magnet 16b, the basket array control member 302 expands to a diameter greater than the magnet diameter and engages the distal magnet 16a. Once engaged, the control member 302 may rotate the distal magnet 16a to align it with the proximal magnet 16b. The control member 302 may also exert additional force on the distal magnet 16a to mate it with the proximal magnet 16b. Once the magnets are aligned and mated, the user pulls back on the delivery device 100 to retract the basket array control member to a smaller diameter than the intestinal incision and retracts the control member 302 into the delivery device 100 for removal from the patient.

FIG. 56B shows a side view of the basket array system and method of FIG. 56A.

FIG. 57A illustrates a basket array control member that manipulates a single magnet. In this embodiment, magnetic anastomosis device 16 is deployed into the lumen. The distal end of the control member 302 is attached to the magnet 16 and by pulling back on the delivery device, the user expands the basket array control member 302 to a diameter greater than the diameter of the magnet 16. The control member 302 engages the magnet 16 to align and position the magnet 16 at the target site to form an anastomosis. Once the magnet 16 is in the correct position, the user pulls back the delivery device 100 to retract the control member 302 to a diameter smaller than the diameter of the magnet and retracts the control member 302 into the delivery device 100 for removal from the patient.

Fig. 57B depicts a side view of the control member deployment of fig. 57A.

Fig. 58 illustrates another concept of an expandable/contractible mechanism configured to control and manipulate a distal anastomosis device within a distal lumen and configured as a balloon. After the proximal magnet 16b is deployed into the proximal lumen 71, the distal magnet 16a is deployed into the distal lumen 70, where the distal magnet self-assembles from a linear form into a polygonal shape (fig. 58 (a)). With the distal magnet 16a deployed (fig. 58 (B)), the user pulls back the delivery device 100 to deploy the balloon sheath control member 303 (fig. 58 (C)). The balloon sheath control member 303 expands within the distal lumen 70 to a diameter that is greater than the diameter of the distal magnet 16a. By pulling on the middle suture 31, the user can control the distal magnet 16a. The balloon sheath control member 303 engages the distal magnet 16a to align it with the proximal magnet 16b ((D) of fig. 58). In some embodiments, the control member 303 may exert additional force on the distal magnet 16a to mate it with the proximal magnet 16 b. Once the magnetic anastomosis devices 16a, 16b are aligned and mated, the balloon-sheath control member 303 is deflated to a diameter smaller than that of the magnetic assembly and retracted into the delivery device 100 for subsequent removal from the patient.

Another concept includes a piercing tip 69 configuration configured to help orient the magnetic portion during deployment of the magnetic press anastomosis device. Fig. 53 illustrates two tip configurations in accordance with various exemplary embodiments. Configuration a includes a piercing tip 69 with a helical support that helps orient magnetic portion 16a during deployment of the magnetic press anastomosis device. Configuration B includes a piercing tip 69 with a wedge-shaped support that helps orient magnetic portion 16a during deployment of the magnetic press anastomosis device. Of course, other configurations are possible to aid in orientation based on the concept of a top configuration.

Latent claims

Various embodiments of the invention may be set forth in the potential claims set forth in the paragraphs following this paragraph (and before the actual claims are presented at the end of the application). These potential claims form part of the written description of the application. Accordingly, the subject matter of the following potential claims may be presented as actual claims in the following procedures directed to this application or any application based on the priority of this application. The inclusion of such a potential claim should not be construed to imply that the actual claim does not contain any of the subject matter of the potential claim. Accordingly, decisions that do not address these potential claims in the subsequent process should not be interpreted as donation of subject matter to the public. These potential claims are not intended to limit the various claims pursued.

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

p1. an apparatus that can be used independently cut, dissect, dilate and cauterize tissue between one or more cooperating devices (e.g., press anastomosis devices) or in combination with other methods to create and/or capture open conduits for pressing or depressurizing or nutrient bypass while, for example, remaining concentric with the deployment channel.

P2. an apparatus having the ability to be delivered into an adjacent wall which can then be used as a conduit to deliver a press anastomosis device.

P3. an apparatus that allows shearing, expanding or resecting tissue between one or more pressing devices.

P4. a device having a retractable sharp tip or energy to provide tissue inactivation.

P5. an apparatus having the ability to deliver into an adjacent lumen a control mechanism comprised of an array of at least one articulating member that expands to a larger diameter than the formed intestinal incision in order to increase the mechanical advantage/gain for controlling the connecting member attached to the distally deployed press anastomosis device. The increased diameter of the control mechanism may also be used as a tool to dilate and/or expand the intestinal incision made.

P6. an apparatus that allows the use of a connecting member to control and manipulate the press device in the distal lumen to create an alignment within 15 ° between the deployment channel axis and the mating axis of the press device. The control mechanism allows movement in distal and proximal directions and can couple and decouple mating press anastomosis devices.

P7. an apparatus having a sharp cutting tip or monopolar or bipolar excitation tip offset to provide tissue inactivation to create an intestinal incision centered coaxially with the working channel of the delivery device. The support of the tip serves as a guide for deploying the control member and the press anastomosis device into the distal lumen so as to wrap it over the support in a prescribed manner to orient and present the press device after deployment. In some configurations, the tip may also be used as a control member (i.e., an energized basket) and/or to dilate an intestinal incision formed.

P8. an expandable/retractable control mechanism comprising a hinge member that expands to a larger diameter than the intestinal incision in order to expand/expand the intestinal incision, align the expression device and add mechanical advantage/gain for controlling the expression anastomosis device.

Incorporated by reference

Throughout this disclosure, references and citations have been made to other documents such as patents, patent applications, patent publications, journals, books, papers, web content, and the like. The entire contents of all such documents are hereby incorporated by reference for all purposes.

Equivalents (Eq.)

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The above embodiments are therefore to be considered in all respects as illustrative and not restrictive of the invention described herein. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are intended to be embraced therein.

Claims (20)

1. An apparatus for deploying a press anastomosis device, the apparatus comprising:

a delivery device having a distal end and a proximal end,

wherein one or more press anastomosis devices are deployable from the distal end; and

a control member, the control member being deployable from the distal end,

wherein the control member is operable to cause the control member to align one or more press anastomosis devices with a deployment channel.

2. The apparatus of claim 1, wherein:

the control member is expandable to a diameter greater than a diameter of the deployment channel to dilate the created intestinal incision, and

the control member is collapsible to a diameter equal to or less than the deployment channel for removal from the intestinal incision.

3. The apparatus of any one of claims 1 to 2, wherein the control member is a basket.

4. The apparatus of any one of claims 1-2, wherein the control member is a balloon cuff.

5. The apparatus of any one of claims 1-2, wherein the control member is a wire-controlled jaw.

6. The apparatus of any one of claims 1-5, wherein the control member is deployable between a distal lumen and a proximal lumen to capture the formed intestinal incision.

7. The apparatus according to any one of claims 1 to 6, wherein the control member is deployable to a distal side of a distal anastomosis device to act as a stop.

8. The apparatus of any one of claims 1 to 7, wherein a piercing device capable of cutting, dissecting and/or dilating tissue to thereby create a deployment channel between two lumens is deployable from the distal end.

9. The apparatus of claim 8, wherein the piercing device is a hot needle.

10. The apparatus of claim 8, wherein the piercing device is a thermal tip that emits monopolar energy.

11. The apparatus of claim 8, wherein the piercing device is a coring needle.

12. The apparatus of claim 8, wherein the piercing device is a spiral.

13. A method for positioning a press anastomosis device, the method comprising the steps of:

deploying a first press anastomosis device from a distal end of the delivery device into the proximal lumen;

positioning the first press anastomosis device against a tissue wall;

piercing the tissue wall to create an intestinal incision between adjacent lumens;

deploying a second anastomosis device into the distal lumen through the intestinal incision;

deploying a control member into the intestinal incision;

expanding the control member to dilate the intestinal incision;

engaging the control member with the second anastomosis device;

rotationally and laterally manipulating the control member with the distal anastomosis devices to align the two anastomosis devices;

bringing the anastomosis devices together to capture the intestinal incision;

Shrinking the control member to a diameter equal to or less than the diameter of the delivery device; and

retracting the control member into the delivery device.

14. The method of claim 13, wherein the control member is deployed to a distal side of the distal anastomosis device to act as a stop.

15. The method of claim 13, wherein the control member is deployed between the anastomosis devices to capture the created intestinal incision.

16. An apparatus for deploying a press anastomosis device, the apparatus comprising:

a delivery device having a proximal end and a distal end, the distal end having the ability to cut, dissect or dilate tissue between adjacent lumens to create an intestinal incision;

a control member deployable into the intestinal incision from the distal end of the delivery device to capture the intestinal incision;

the control member is expandable to a diameter greater than a diameter of the intestinal incision to dilate the intestinal incision;

the control member is rotatably steerable to engage and align a distally deployed anastomosis device with a proximal anastomosis device;

the control member is laterally steerable to bring the distal anastomosis device toward the proximal anastomosis device and mate them;

The control member is collapsible to a diameter equal to or less than the diameter of the delivery device; and

the control member is retractable into the delivery device.

17. The apparatus of claim 16, wherein the control member is a basket.

18. The apparatus of claim 16, wherein the control member is a balloon cuff.

19. The apparatus of claim 16, wherein the control member is a wire controlled jaw.

20. The apparatus according to any one of claims 16 to 19, wherein the control member is deployable to a distal side of a distal anastomosis device to act as a stop.