Systems, devices and methods for delivering and positioning a magnetic anastomosis compression device and then forming an anastomosis - Patents.com

Abstract

The present invention provides a system including a fixation device for improving the placement and fixation of a magnetic compression device at a desired target site for forming an anastomosis between tissues. The delivery device is configured for use in the placement and fixation of the magnetic compression device including one or more guide members, such as sutures or wires, used to position and / or manipulate the device once delivered to the target tissue to achieve optimal placement and subsequent anastomosis formation.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 177200, filed April 20, 2021, entitled SYSTEMS, DEVICES, AND METHODS FOR DELIVERING AND POSITIONING MAGNETIC ANASTOMOSIS COMPRESSION DEVICES FOR SUBSEQUENT FORMATION OF ANASTOMOSES (Attorney Docket No. 121326-10901), which is incorporated by reference in its entirety.

[0002] The subject matter of this patent application may be related to the subject matter of U.S. patent application Ser. No. 17 / 108840, entitled SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES, filed on December 1, 2020 (Attorney Docket No. 121326-11101), which is a continuation-in-part of, and therefore claims priority to, International Patent Application No. PCT / US2019 / 035202, having an international filing date of June 3, 2019 (Attorney Docket No. 121326-11102). This international patent application, PCT Application No. PCT / US2019 / 035202, claims the benefit of and priority to U.S. Provisional Application No. 62 / 679,810, filed June 2, 2018, U.S. Provisional Application No. 62 / 798,809, filed January 30, 2019, and U.S. Provisional Application No. 62 / 809,354, filed February 22, 2019, the contents of each of which are incorporated by reference in their entirety.

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

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

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

[0006] Nevertheless, the locations where compression anastomoses can be used are limited because magnet or coupling placement is difficult. In most cases, magnets or couplings must be delivered as two separate assemblies, requiring either an open surgical field or bulky delivery devices. For example, existing magnetic compression devices are limited to structures small enough to be deployed with a delivery conduit, such as an endoscopic instrument channel or laparoscopic port. When these relatively small structures are used, the anastomoses formed are small and suffer from short-term patency. Furthermore, magnet or coupling placement can be inaccurate, which can lead to anastomoses being formed in undesirable or incorrect locations.

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

[0008] overview Various embodiments of the present invention provide improved devices and techniques for minimally invasively creating anastomoses in the body that facilitate faster, less expensive treatments for chronic diseases such as obesity and diabetes, and that reduce the time and pain associated with palliative treatments for diseases such as cancer.

[0009] More specifically, the present invention provides a fixation device for improving the placement and fixation of a magnetic compression device at a desired target site to form an anastomosis between tissues. The fixation device is configured for use in the placement and fixation of a magnetic compression device that includes one or more guide members, such as sutures or wires, that are used to position and / or manipulate the device once delivered to the target tissue to achieve optimal placement and anastomosis formation.

[0010] For example, in one embodiment described herein, a fixation device for a compression anastomosis device includes a button member shaped and dimensioned to receive one or more guide members. The guide member may be coupled to the distal compression anastomosis device, and the guide member may be movable along the guide member from the delivery device toward the distal anastomosis device and the target site. In one embodiment, the button member may then be centered relative to the intestinal incision and the distal anastomosis device. According to one embodiment, a plug member shaped and dimensioned to be received within the proximal end of the button member is secured within the button member by a friction fit, thereby fixing the one or more guide members and the distal anastomosis device in place at the target site.

[0011] In various alternative embodiments, the plug member is tapered in width, with the proximal end being wider than the distal end. The central opening of the button member may also be tapered in width from the most proximal opening to the most distal opening. The button member may be shaped and / or sized to be positioned between the distal and proximal anastomosis devices. The button member may be sized to have a diameter greater than the diameter of the formed intestinal incision. In various alternative embodiments, the proximal end of the button member may be sloped and / or dome shaped. The button member may be configured to engage a portion of a first tissue wall of the patient's hollow body. Both the button member and the plug member may be manufactured from medical grade materials.

[0012] In an alternative embodiment, the fixation device for securing the compressed anastomosis device includes deployable self-assembling fixation members. The self-assembling fixation members may be capable of holding the position of the compressed anastomosis device positioned at the target site against a tissue wall within the patient. In various embodiments, the fixation members may be capable of capturing the shaped intestinal incision between the distal and proximal ends of the members and holding the compressed anastomosis device in place until it is mated with a second compressed anastomosis device.

[0013] In various alternative embodiments, the fixation members can be compressed within the delivery device and expand to a deployed configuration upon exiting the delivery device.

[0014] In some embodiments, the fixation member may be a circular device, a balloon device, a "petal" device, a ratchet device, a bulge tube device, or a spiral spring device.

[0015] In an alternative embodiment, the device for assisting in the placement and fixation of compression anastomotic devices includes a limiting member that in some embodiments can trap a pair of compression anastomotic devices between a proximal end and a distal end of the member. In some embodiments, the limiting member can be rigidly attached to the distal anastomotic device. In some embodiments, the limiting member can only move in the compression direction, thereby preventing any increase in the distance between the proximal and distal anastomotic devices.

[0016] In various alternative embodiments, the restricting member may be compressed within the delivery device and may be capable of expanding to a deployed configuration upon exiting the delivery device, hi some embodiments, the restricting member may be capable of compressing back to a compressed configuration such that it can be retracted into the delivery device and removed from the patient.

[0017] In various alternative embodiments, the restraining members may be balloons, wire arrays, "petals," bulge tubes, ratchet devices, suspender devices, and / or rebar binding devices. [Brief description of the drawings]

[0018] Features and advantages of the claimed subject matter will become apparent from the following detailed description of the corresponding embodiments, which description should be discussed with reference to the accompanying drawings. [Figure 1] 1 is a schematic diagram of an anastomosis formation system consistent with the present disclosure. [Diagram 2]FIG. 1 shows several potential anatomical targets for anastomosis creation; arrow A, stomach to small intestine; arrow B, small intestine to large intestine; arrow C, small intestine to small intestine; arrow D, large intestine to large intestine; and arrow E, stomach to large intestine. [Diagram 3] FIG. 1 illustrates an exemplary magnetic anastomosis device being fed through an endoscopic instrument channel such that the individual magnet segments self-assemble to form a larger magnetic structure, in this particular case an octagon. [Figure 4A] FIG. 1 shows two magnetic anastomosis devices attracting each other through tissue. As shown, the devices each have eight magnetic segments, although alternative configurations are possible. When the two devices are joined, tissue trapped between the devices will necrotize, resulting in the anastomosis being formed. Alternatively, the tissue joined by the devices may be perforated after the devices are joined, thereby immediately forming the anastomosis. [Figure 4B] 1 illustrates two magnetic anastomosis devices that join together by magnetic attraction and capture intervening tissue, In some instances, an endoscope may be used to cut the surrounded tissue. [Figure 5A] FIG. 13 shows a needle delivering a first magnetic device to a target site within a first portion of a hollow body. [Figure 5B] A second magnetic device is then deployed within a second portion of the hollow body adjacent the target site. [Figure 6] FIG. 6A shows delivery of a magnet assembly into the gallbladder by an ultrasound endoscopic guided needle, which then couples with a second magnet assembly in the stomach or duodenum, as shown in FIG. 6B. [Figure 7] FIG. 13 illustrates a single guide member for deploying and manipulating the magnetic anastomosis device. [Figure 8A] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8B] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8C]13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8D] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8E] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 8F] 13A-13D illustrate the deployment of a self-closing magnetic anastomosis device with multiple guide members. [Figure 9A] 13 illustrates the creation of an enterotomy in at least a first portion of a first tissue at a target site via a needle of an access device. [Figure 9B] 13 illustrates the creation of an enterotomy in at least a first portion of a first tissue at a target site via a needle of an access device. [Figure 9C] FIG. 1 illustrates the delivery and self-assembly of a first magnetic anastomosis device to a first tissue. [Figure 9D] 13A and 13B show a first magnetic anastomosis device being positioned by manipulating a guide member coupled to the first magnetic anastomosis device, and fixing the first magnetic anastomosis device in place via a fixing device. [Figure 9E] 13A and 13B show a first magnetic anastomosis device being positioned by manipulating a guide member coupled to the first magnetic anastomosis device, and fixing the first magnetic anastomosis device in place via a fixing device. [Figure 9F] 13A and 13B show a first magnetic anastomosis device being positioned by manipulating a guide member coupled to the first magnetic anastomosis device, and fixing the first magnetic anastomosis device in place via a fixing device. [Figure 9G] 13A and 13B show a first magnetic anastomosis device being positioned by manipulating a guide member coupled to the first magnetic anastomosis device, and fixing the first magnetic anastomosis device in place via a fixing device. [Figure 9H]FIG. 13 illustrates a second magnetic anastomosis device being delivered and positioned to a second tissue adjacent to the first tissue at a target site, and then the first and second magnetic anastomosis devices being coupled to each other by magnetic attraction, thereby forming an anastomosis after compressing the tissue. [Figure 9I] FIG. 13 illustrates a second magnetic anastomosis device being delivered and positioned to a second tissue adjacent to the first tissue at a target site, and then the first and second magnetic anastomosis devices being coupled to each other by magnetic attraction, thereby forming an anastomosis after compressing the tissue. [Figure 10] FIG. 13 illustrates a balloon fixation mechanism that can be inflated from the opposite side of the intestinal incision from the compression anastomosis device, according to one exemplary embodiment. [Figure 11] 13A-13C show a circular fixation mechanism that can self-deploy from the opposite side of the intestinal incision from the compression anastomosis device, according to one exemplary embodiment. [Figure 12] FIG. 13 illustrates a "petal" fixation mechanism that can be deployed from the opposite side of the intestinal incision from the compression anastomosis device, according to one exemplary embodiment. [Figure 13] FIG. 13 illustrates a fixation mechanism that can be deployed from the side of the intestinal incision opposite the compression anastomosis device, according to one exemplary embodiment, which also includes a ratchet mechanism that allows movement only in the direction of compression and prevents any increase in the distance between the compression anastomosis device and the fixation mechanism. [Figure 14] 13A-13C illustrate a bulge tube fixation mechanism that expands on either side of the intestinal incision by pulling the two ends towards each other, thereby fixing the compression anastomosis device at the site of the intestinal incision, according to one exemplary embodiment. [Figure 15] FIG. 13 illustrates a spiral spring anchoring mechanism that can be deployed from the opposite side of the intestinal incision from the compression anastomosis device, according to one exemplary embodiment. [Figure 16] FIG. 1 illustrates a balloon restraining mechanism according to one exemplary embodiment. [Figure 17] FIG. 1 illustrates a wire array restraining mechanism according to an exemplary embodiment. [Figure 18] FIG. 1 illustrates a “petal” limiting mechanism according to one exemplary embodiment. [Figure 19] FIG. 1 illustrates a bulge tube restraining mechanism according to an exemplary embodiment. [Figure 20] FIG. 13 illustrates a limiting mechanism that also includes a ratchet mechanism that only allows movement in the compression direction and prevents any increase in the distance between the compression anastomosis device and the fixation mechanism, according to one exemplary embodiment. [Figure 21] FIG. 1 illustrates a limiting mechanism with suspenders according to an exemplary embodiment. [Figure 22] FIG. 1 illustrates a rebar connection limiting mechanism according to an example embodiment.

[0019] For a complete understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in conjunction with the above-mentioned drawings. Although the present disclosure has been described in connection with exemplary embodiments, it is not intended that the disclosure be limited to the specific forms set forth herein. It is self-evident that various omissions and equivalent substitutions are anticipated where suggested or expedient by the circumstances.

[0020] Detailed Description The present invention provides a system for improving placement of a magnetic compression device at a desired target site to form an anastomosis between tissue. The system generally includes an access device configured to be disposed within a hollow body of a patient 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 and to assist in forming an anastomosis at a target site (desired anatomical location) within the hollow body. The access device provides access to the first and second portions of tissue of the hollow body to form an anastomosis between the tissue at the target site and is further configured to deliver and position first and second implantable magnetic anastomosis devices relative to the first and second portions of tissue or adjacent tissue to form an anastomosis between the tissue at the target site. The first and second implantable magnetic anastomosis devices are configured to magnetically attract each other through a predetermined tissue region of a total thickness of the tissue wall at the target site and exert a compressive force on the predetermined region to form the anastomosis.

[0021] The system further includes a fixation device for improving the placement and fixation of the magnetic compression device at a desired target site to form an anastomosis between tissues. The fixation device is configured for use in placement and fixation of the magnetic compression device, including one or more guide members, such as sutures or wires, used to position and / or manipulate the device once delivered to the target tissue to achieve optimal placement and anastomosis formation. For example, in the embodiments described herein, at least one of a pair of self-assembling magnetic anastomosis devices (configured to be joined together by magnetic attraction, thereby capturing intervening tissue that subsequently dies resulting in the formation of an anastomosis) includes one or more guide members coupled thereto. Each guide member may include a distal end coupled to a respective portion of the anastomosis device, and a proximal end, and manipulation of the proximal end (i.e., increasing or decreasing tension) can manipulate the position and orientation of the anastomosis device after it self-assembles into a predetermined shape (i.e., a polygon).

[0022] When the first magnetic anastomosis device is delivered to the target tissue site and deployed, the one or more guide members typically extend from the anastomosis device, through the intestinal incision made by the delivery needle, through the hollow body of the patient, back towards the access device, and possibly to an external portion of the patient. For example, if an anastomosis is to be formed between the stomach and the gallbladder (or the duodenum and the gallbladder), the first magnetic anastomosis device may be placed and deployed within the gallbladder, after which the guide members coupled to the first magnetic anastomosis device may remain attached to the anastomosis device and extend back through the gastrointestinal tract towards the access device, and possibly to the outside of the patient (i.e., from the anastomosis device, through an access site into the gallbladder, into the stomach, up the esophagus, and out the mouth).

[0023] The fixation devices of the present invention are configured to fix a first magnetic anastomosis device in place at a target site, thereby ensuring that the first magnetic anastomosis device remains in place relative to the target site while a surgeon delivers and deploys a second magnetic anastomosis device to the target site. For example, fixation devices typically include a button member that includes a body having a distal end, an opposing proximal end, and a central opening or through hole extending from the distal end to the proximal end. The openings are shaped and / or dimensioned to receive one or more guide members therethrough such that the button member can typically travel along the length of the guide members extending from the first magnetic anastomosis device through the intestinal incision.

[0024] For example, once the first magnetic anastomosis device is deployed at the target site (i.e., passes through an intestinal incision made through a first tissue at the target site and self-assembles to form a predetermined shape), the guide member extending back through the intestinal incision can be passed through a central opening in the body of the button member. The surgeon then need only pull on the guide member taught to pull the deployed first magnetic anastomosis device to engage a first side of the first tissue and substantially center the first magnetic anastomosis device relative to the intestinal incision. The button member can then be moved along the length of the guide member (passing through the central opening) until the distal end of the body engages the opposing side of the first tissue, thereby centering the button member relative to the intestinal incision and the first magnetic anastomosis device on the opposite side.

[0025] The fixation device further includes a plug member, the plug member including a distal end shaped and / or dimensioned to be received within at least a proximal portion of the central opening of the button member and held therein by a friction fit. For example, the plug member may be tapered in width from the proximal end to the distal end (i.e., greater in width at the proximal end and smaller in width at the distal end). Thus, upon pulling the guide member taught to position the button member to engage the first tissue, the surgeon may advance the plug member into the central opening of the button, thereby essentially fixing the button member and the opposing first magnetic anastomosis device in place relative to the target site (i.e., fixing on opposite sides of the first tissue wall). More specifically, the plug member fixes the button member and the guide member passing through the central opening of the button member together by a friction fit. In some alternative embodiments, the plug member may be substituted for any type of friction fit device that holds the guide member in place on the button member. The guide member may be cut and removed once the anchoring device and the opposing first magnetic anastomosis device are substantially fixed in place along the tissue wall.

[0026] Once the first magnetic anastomosis device is secured in place via the fixation device, the second magnetic anastomosis device can then be delivered via the access device and deployed to the target site. Upon reaching the target tissue site, the first and second magnetic anastomosis devices magnetically attract each other through a predetermined tissue region of the combined thickness of the tissue walls (i.e., gallbladder and stomach walls, upper and lower intestinal walls, etc.) at the target site, exerting a compressive force on the predetermined region to form an anastomosis. In some alternative embodiments, the fixation device engages both the first and second tissue, thereby compressing both tissues against the first anastomosis device and securing the first anastomosis device in a precise mating position with the second anastomosis device.

[0027] Thus, the fixation device of the present disclosure provides improved placement and fixation of at least a first magnetic compression device at a desired target site, thereby improving the positioning and placement of a second corresponding magnetic anastomosis device at the subsequent target site, resulting in the formation of an accurate anastomosis between tissues. The fixation device is configured to utilize a guide member from a first magnetic anastomosis device that has already been deployed and placed at a desired target tissue site as a means for fixing the first magnetic anastomosis device substantially in place, thereby ensuring highly accurate and improved placement of a subsequent second corresponding magnetic anastomosis device to be coupled to the first device (i.e., ensuring that the anastomosis devices are placed at the intended target site and coupled to each other), thereby achieving optimal placement and anastomosis formation.

[0028] 1 is a schematic diagram of an anastomosis formation system 10 for providing improved placement of a magnetic anastomosis device 16 at a desired site, thereby increasing the accuracy of anastomosis formation between tissues within a patient 12. The system 10 generally includes an access device 14, a fixation device 100, the magnetic anastomosis device 16, and an imaging modality 20.

[0029] The access device 14 may generally include a scope, including but not limited to an endoscope, laparoscope, catheter, trocar, robotic device, or other delivery device. Placement of the anastomosis device may occur in an open field. For most applications described herein, the access device 14 is an endoscope and includes a delivery needle 28 configured to deliver the magnetic anastomosis device 16a, 16b. Thus, the system 10 of the present disclosure relies on a single endoscope 14 to deliver the two magnetic devices 16a, 16b. As described in more detail herein, the surgeon may advance the endoscope 14 within the hollow body of the patient 12 based on a visual representation of the location of the target site provided by the imaging modality 20 and position the endoscope 14 at a desired anatomical location for forming an anastomosis. For example, the imaging modality 20 may include a display on which an image or other visual representation indicative of the target site is displayed to the surgeon when performing medical imaging procedures, including but not limited to ultrasound (US), wavelength detection, x-ray based imaging, illumination, computed tomography (CT), radiography, and fluoroscopy, or combinations thereof. The surgeon can then rely on such visual depiction as he advances the endoscope through the hollow body to position the access device 14 in a portion of tissue adjacent to another portion of tissue at the target site, thereby ensuring that placement of the magnetic devices 16a, 16b is accurate.

[0030] It should be noted that hollow bodies through which the access device 14 may pass include, but are not limited to, the stomach, gallbladder, pancreas, duodenum, small intestine, large intestine, intestinal tract, the vascular system including veins and arteries, and the like.

[0031] In some embodiments, the self-assembling magnetic devices 16a, 16b are used to create a bypass in the gastrointestinal tract. Such a bypass may be used to treat cancerous blockages, weight loss or obesity, or may also be used to treat diabetes and metabolic disease (i.e., metabolic surgery).

[0032] FIG. 2 illustrates various gastrointestinal anastomosis targets that may be addressed by the device of the present invention, 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). The present invention thus provides improved devices and techniques for minimally invasively forming anastomoses within the body, for example, the gastrointestinal tract. Such devices and techniques facilitate faster and less expensive treatments for chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, such as gastric or colon cancer.

[0033] For example, if the hollow body through which the access device 14 may pass is the intestine of a patient, the first portion may be a distal portion of the intestine and the second portion may be a proximal portion of the intestine. The intestine includes any segment of the digestive tract extending from the pyloric sphincter of the stomach to the anus. In some embodiments, the anastomosis is formed to bypass diseased, malformed or dysfunctional tissue. In some embodiments, the anastomosis is formed to alter the "normal" digestive process in an effort to reduce or prevent other diseases, such as diabetes, hypertension, autoimmune diseases or musculoskeletal diseases. It is noted that the system may be used to form an anastomosis between a first portion of a hollow body tissue at a target site and an adjacent second hollow body tissue (e.g., a portal between the stomach and gallbladder, between the duodenum and gallbladder, stomach to small intestine, small intestine to large intestine, stomach to large intestine, etc.).

[0034] In an endoscopic procedure, a single endoscope 14 may be used to deliver the self-assembling magnetic device 16. The deployment of the magnetic device 16 is shown diagrammatically in FIG. 3. As shown, an exemplary magnetic anastomosis device 16 is delivered through the endoscope 14, which causes the individual magnet segments to self-assemble and form a larger magnetic structure, in this particular case an octagon. When used with the techniques described herein, when the device is deployed as a completed assembly, the device 16 allows for delivery of larger magnetic structures through a small delivery conduit 14 than would otherwise be possible, for example, within a standard endoscope. Larger magnetic structures also allow for the creation of larger and more robust anastomoses, achieving greater surgical success. The magnetic device 16 is radiopaque and echogenic, so the device may be positioned using fluoroscopy, direct visualization (transillumination or tissue impaction), and ultrasound, for example, an ultrasound endoscope. The device 16 may be decorated with radiopaque paint or other markers to aid in identifying the polarity of the device during placement.

[0035] The magnetic anastomosis device 16 of the present invention generally includes a plurality of magnetic segments that can assume a delivery configuration and a deployed configuration. The delivery configuration is typically linear, which allows the device to be delivered to tissue through a laparoscopic "keyhole opening" incision or through a natural pathway, such as the esophagus, using an endoscope 14 or similar device. Additionally, the delivery configuration is typically somewhat flexible, which allows the device to be guided through various curvatures within the body. Once the device 16 is delivered, it automatically transforms from the delivery configuration to the deployed configuration, thereby assuming the desired shape and size of the deployed configuration. The self-transformation from the delivery configuration to the deployed configuration is guided by a coupling structure that causes the magnetic segments to move as desired without intervention. Exemplary self-assembling, self-closing, self-opening, etc. magnetic anastomosis devices 16 are described in U.S. Pat. Nos. 8,870,898, 8,870,899, 9,763,664, and U.S. patent application Ser. No. 14 / 805,916, filed July 22, 2015, the contents of each of which are incorporated herein by reference in their entirety.

[0036] As shown in FIG. 4A, the magnetic anastomosis procedure generally involves placing first and second magnetic structures 16a, 16b adjacent to first and second portions 20, 24 of tissues 26, 22, respectively, thereby bringing the tissues 22, 26 together. When the two devices 16a, 16b are brought into proximity, the magnetic structures 16a, 16b combine to bring the tissues 22, 26 together. Over time, an anastomosis of the size and shape of the devices 16a, 16b will form and the devices will fall off the tissues. In particular, the tissues 22, 26 surrounded by the devices will be necrotized and decomposed, providing an opening between the tissues.

[0037] Alternatively, the coupled devices 16a and 16b create sufficient compressive force to stop blood flow to the tissue 22, 26 trapped between the devices, allowing the surgeon to create an anastomosis by making an incision in the tissue 22, 26 surrounded by the devices, as shown in FIG. 4B.

[0038] In yet another embodiment, as described in more detail herein and shown in Figures 9A-9I, the surgeon can first incise or puncture tissue 22, 26 and then advance device 16a into hollow body portion 20, thereby placing device 16a around the incision in tissue 26. The surgeon can then place device 16b in hollow body portion 24, thereby placing device 16b around the incision in tissue 22, and then couple devices 16a and 16b together, such that devices 16a, 16b surround the incision. As before, once devices 16a, 16b are coupled together, blood flow to the incision is immediately cut off.

[0039] While the figures and structures of this disclosure relate primarily to annular or polygonal structures, it is understood that the feeding and assembly techniques described herein can be used to form a variety of deployable magnetic structures. For example, the self-assembling magnets can reassemble into polygonal structures such as circles, ellipses, squares, hexagons, octagons, decagons, or other geometric structures that form closed loops. The devices 16a, 16b can additionally include handles, suture loops, jaws, and prongs as needed to achieve desired performance and make feeding (and removal) easier.

[0040] As described above, the self-assembling magnetic anastomosis devices 16a, 16b may be delivered to a target site via an access device 14. For example, as shown in FIG. 5A, the access device 14 may include a delivery needle 28 (e.g., a puncture needle) that is used to deliver (by puncture) a first magnetic anastomosis device 16a into the lower small intestine, and then a second magnetic device 16b is deployed into the upper small intestine at a tissue location adjacent to the target site (shown in FIG. 5B). Note that delivery may be guided by fluoroscopy or endoscopic ultrasound. Following self-assembly, the small intestine magnetic devices 16a, 16b bind to each other (e.g., magnetically attract each other) through a predetermined tissue region of the total thickness of the tissue wall at the target site, and exert a compressive force in the predetermined region to form an anastomosis.

[0041] FIG. 6A shows an endoscopic ultrasound guided needle delivering a magnet assembly 16a into the gallbladder 62, which then couples with a second magnet assembly 16b in the stomach 60 or duodenum 61 as shown in FIG. 6B. Thus, the described procedure may be used in conjunction with a procedure to remove or block bypassed tissue. For example, an endoscopic ultrasound (EUS) may be used to facilitate transgastric or transduodenal access guided into the gallbladder 62 for placement of a self-assembling magnetic anastomosis device 16a. Once access to the gallbladder 62 is achieved, various strategies may be used to maintain an open portal between the stomach 60 and the gallbladder 62 or between the duodenum 61 and the gallbladder 62. In another embodiment, gallstones may be retrieved and fluids drained by endoscope. For example, an anastomosis may be formed between the gallbladder 62 and the stomach 60 using the described method. Once the gallbladder 62 is accessed in a transgastric or transduodenal manner, gallstones may be removed. Additionally, the gallbladder mucosa can be resected using any number of modalities, including but not limited to argon plasma coagulation (APC), photodynamic therapy (PDT), and sclerosing agents (e.g., ethanolamine or ethanol).

[0042] As discussed above, the fixation device 100 improves the placement and fixation of the magnetic compression devices 16a, 16b at a desired target site for forming an anastomosis between the tissues 22, 26. The fixation device 100 is configured to be used to place and fix the magnetic compression devices 16a, 16b, including one or more guide members 30, such as sutures or wires, that are used to position and / or manipulate the device once delivered to the target tissue to achieve optimal placement and anastomosis formation.

[0043] FIG. 7 shows a single guide member 30 for deploying and manipulating the magnetic anastomosis device 16. For example, once the self-assembling magnetic device 16 has been delivered to tissue, it is beneficial to be able to manipulate the position of the device 16. While the device 16 may be manipulated with conventional tools such as forceps, it is often easier to manipulate the position of the deployed device 16 with a guide member 30 such as a suture or wire. As shown in FIG. 7 and FIGS. 8A-8F, various attachment points may be used to control the position and deployment of the self-assembling magnetic anastomosis device 16.

[0044] For example, as shown in FIG. 7, the guide member 30 may be coupled to a single distal segment 16, which results in an attachment point that provides freedom of translational movement during self-assembly. The configuration shown in FIG. 7 is also notable in that it allows for a closure force to be applied to the most distal segment. That is, if one or more segments become entangled in tissue or are otherwise prevented from self-assembly, the proximal pulling force of the guide member 30 may assist the device 16 to complete self-assembly. Once self-assembly is complete, the device 16 may be positioned by the guide member 30 as described above so that it may be coupled with another device (not shown) to form an anastomosis. Although not shown in FIG. 7, it is contemplated that additional structures, such as a solid pusher or guide tube, may be used to deploy the device 16 at a desired location.

[0045] The guide member 30 may be fabricated from a variety of materials to achieve the desired mechanical properties and biocompatibility. The guide member 30 may be constructed from metals, such as wires, such as stainless steel wires or nickel alloy wires. The guide member may be constructed from natural fibers, such as cotton or animal products. The guide member may be constructed from polymers, such as biodegradable polymers, such as polymers that include repeating units of lactic acid, lactone, or glycolic acid, such as polylactic acid (PLA). The guide member may be constructed from high tensile strength polymers, such as Tyvek™ (high density polyethylene fiber) or Kevlar™ (para-aramid fiber). In one embodiment, the guide member 30 is constructed from a biodegradable suture, such as VICRYL™ (polyglactin 910) suture available from Ethicon Corp., Somerville, NJ.

[0046] The guide member 30 may be coupled to the self-assembling magnetic anastomosis device 16 by a number of different configurations and attachment mechanisms. The guide member 30 may simply be tied to the device 16, or the guide member 30 may be attached to the device 16 by an adhesive, such as an acrylate adhesive, or fasteners such as clips, screws, or rivets.

[0047] In some embodiments, the magnetic anastomosis device 16 may include multiple guide members 30(1)-30(4). Various attachment points may be used to control the position and deployment of the self-assembling magnetic anastomosis device 16, as shown, for example, in FIGS. 8A, 8B, 8C, 8D, 8E, and 8F. As shown, four guide members 30(1)-30(4) may be coupled to four separate segments of the device 16. Each guide member 30 may include a distal end coupled to a respective portion of the anastomosis device 16 and a proximal end, such that manipulation of the proximal end (i.e., increasing or decreasing tension) may manipulate the position and orientation of the anastomosis device 16 after it self-assembles into a predetermined shape (i.e., a polygon). For example, as shown, guide member 30(1) is coupled to the distal-most end segment, guide members 30(2) and 30(3) are coupled to the intermediate segments (segments between the distal-most end segment and the proximal-most end segment), and guide member 30(4) is coupled to the proximal-most end segment.

[0048] 9A-9I show that a first magnetic anastomosis device 16a is delivered to and placed at a target site and secured to a first tissue 26 (i.e., distal tissue) via a securing device 100, and then a second magnetic anastomosis device 16b is delivered to and placed at a second tissue 22 (i.e., proximal tissue) at the target site, where the first magnetic anastomosis device 16a and the second magnetic anastomosis device 16b are magnetically coupled to join the first tissue 26 and the second tissue 22, and then an anastomosis is formed.

[0049] 9A and 9B illustrate the formation of an intestinal incision 63 in at least a first portion of the distal tissue 26 at the target site via the needle 32 or other puncture device of the access device 14. The distal tissue 26 may include, for example, an intestinal wall. A surgeon may, for example, pass the access device through the gastrointestinal tract to locate the target site (i.e., the site where an anastomosis is desired to be formed). As shown in FIG. 9B, when puncturing the tissue wall 26, the needle 32 may be further configured to anchor 34 or otherwise secure the location of the target site. FIG. 9C illustrates the first magnetic anastomosis device 16a being delivered through the intestinal incision 63 formed in the distal tissue wall 26 into the lumen or cavity of the hollow body for self-assembly. As described above, the device 16a is configured to self-assemble into a deployed configuration (i.e., a polygon, such as an octagon). As shown, the device 16a further includes a guide member 30.

[0050] 9D-9G illustrate positioning the first magnetic anastomotic device 16a by manipulating a guide member 30 coupled to the first magnetic anastomotic device 16a and securing the first magnetic anastomotic device 16a in place via a securing device 100. When the device 16a is fully deployed, for example as shown in FIG. 9D, the one or more guide members 30 may extend generally from the anastomotic device 16a through the enterotomy 63.

[0051] The fixation device 100 of the present invention is configured to fix the first magnetic anastomosis device 16a in place at the target site, thereby ensuring that the first magnetic anastomosis device 16a remains in place relative to the target site while the surgeon delivers and deploys the second magnetic anastomosis device 16b to the target site. As shown, for example, in FIG. 9E, the fixation device 100 typically includes a button member having a body having a proximal end 102, an opposing distal end 104, and a central opening 106 or through hole extending from the distal end 104 to the proximal end 102. The opening 106 is shaped and / or sized to receive one or more guide members 30 therethrough such that the button member 100 can typically be moved along the length of the guide members 30 extending from the first magnetic anastomosis device 16a through the intestinal incision 63, such that the fixation device 100 advances toward the tissue 26. For example, once the first magnetic anastomosis device 16a is deployed at the target site (i.e., passes through an intestinal incision 63 formed through a first tissue 26 at the target site and self-assembles to form a predetermined shape), the guide member 30 extending back through the intestinal incision 63 can be passed through the central opening 106 of the body of the button member 100. Thereafter, as shown in FIG. 9E, the surgeon need only pull on the guide member 30 pulled to pull the deployed first magnetic anastomosis device 16a into engagement with a first side of the distal tissue 26, substantially centering the first magnetic anastomosis device 16a relative to the intestinal incision 63 and securing the first magnetic device 16a relative to the distal tissue 26. The button member 100 can then be moved along the length of the guide member 30 through the central opening 106 until the distal end 104 of the body engages the opposing side of the distal tissue 26, thereby centering the button member 100 relative to the intestinal incision 63 and the opposing first magnetic anastomosis device 16a.

[0052] As shown in Figures 9F and 9G, the fixation device 100 further includes a plug member 108 including a distal end shaped and / or dimensioned to be received within at least a proximal portion of the central opening 106 of the button member 100 and retained therein by a friction fit.

[0053] For example, the plug member 108 may taper in width from the proximal end to the distal end (i.e., greater in width at the proximal end and less in width at the distal end). Thus, when pulling the guide member 30 taught to position the button member 100 into engagement with the first tissue 26, the surgeon may advance the plug member 108 into the central opening 106 of the button 100, thereby essentially locking the button member 100 and the opposing first magnetic anastomosis device 16a in place relative to the target site (i.e., on opposite sides of the distal tissue wall 26).

[0054] More specifically, the plug member 108 secures the button member 100 and the guide member 30, which passes through a central opening 106 in the button member 100, together via a friction fit. The guide member 30 may be cut and removed once the fixation device 100 and the opposing first magnetic anastomosis device 16a are substantially fixed in place along the tissue wall 26.

[0055] Once the first magnetic anastomosis device 16a is secured in place via the fixation device 100, the second magnetic anastomosis device 16b can then be delivered through the access device 14 and deployed at the target site, as shown in Figures 9H and 9I. Upon reaching the target tissue site, the first and second magnetic anastomosis devices 16a, 16b will magnetically attract each other through a predetermined tissue area of ​​the combined thickness of the proximal tissue 22 and distal tissue 26 walls (i.e., the walls of the gallbladder 62 and stomach 60, the upper and lower intestinal walls, etc.) at the target site, exerting a compressive force on the predetermined area to form an anastomosis. It should be noted that the button member of the fixation device 100 is shaped and / or dimensioned to be positioned and remain located between the first magnetic anastomosis device 16a and the second magnetic anastomosis device 16b when the devices 16a, 16b are magnetically attracted to each other and coupled. In particular, the button member 100 has a diameter smaller than the inner diameter of the polygon of each anastomosis device 16a, 16b when in the deployed configuration, such that the button member 100 does not interfere with the magnetic coupling between the corresponding segments of the first and second magnetic anastomosis devices 16a, 16b. However, the diameter of the button member 100 is larger than the diameter of the intestinal incision 63. Thus, the button member 100 remains substantially fixed in position within the predetermined area of ​​tissue to be necrotized and is subsequently expelled once the anastomosis is formed. Additionally, the button member 100 may include contours to further prevent or reduce the possibility of interfering with the magnetic coupling between the devices 16a, 16b. For example, at least the proximal end 102 of the button member 100 may have a sloped or domed shape.

[0056] Thus, the fixation device 100 of the present disclosure provides improved placement and fixation of at least a first magnetic compression device 16a at a desired target site, which improves the positioning and placement of a subsequent second corresponding magnetic anastomosis device 16b at the target site, resulting in the formation of an accurate anastomosis between tissues. The fixation device 100 is configured to utilize the guide member 30 from a first anastomosis device 16a already deployed and placed at a desired target tissue site as a means to substantially fix the first magnetic anastomosis device 16a in place, thereby ensuring highly accurate and improved placement of a subsequent second corresponding magnetic anastomosis device 16b to be coupled to the first device 16a (i.e., ensuring that the anastomosis devices are placed at the intended target site and coupled to each other), thereby achieving optimal placement and anastomosis formation.

[0057] An additional exemplary embodiment includes a device having a deployable self-assembling fixation mechanism comprised of a body that holds the position of the compressed anastomotic device 16 positioned at the target site against the first tissue wall 26 of the hollow body. The fixation member captures and holds the intestinal incision 63 in position from the side opposite the compressed anastomotic device 16a until a second compressed anastomotic device 16b can be coupled to the fixed device 16a. The fixation member may be rotated along a central axis to manipulate the anastomotic devices to align the poles of a pair of anastomotic devices.

[0058] FIG. 10 illustrates a balloon fixation mechanism 64 that can be inflated from the side of the intestinal incision 63 opposite the compressed anastomosis device 16a, according to one exemplary embodiment. Upon deployment of the first magnetic anastomosis device 16a, the balloon fixation mechanism 64 is deployed through the created intestinal incision 63. The balloon mechanism 64, which was in a deflated / compressed position while stored within the access device 14, is inflated to a deployed configuration as shown in FIG. 10. The balloon fixation mechanism 64 engages the distal anastomosis device 16a and holds the anastomosis device 16a in place against the first tissue wall 26, ensuring accurate placement of the resulting anastomosis. In some alternative embodiments, the fixation mechanism 64 may hold the anastomosis device 16a against both tissue walls 22, 26. The fixation mechanism 64 may remain inside the patient after the access device 14 is removed. Over time, the fixation mechanism 64 and anastomotic devices 16a, 16b may fall away from the formed anastomosis and be removed from the patient, or may naturally disappear.

[0059] FIG. 11 illustrates a circular fixation mechanism 65 that can self-deploy from the side of the intestinal incision 63 opposite the compressed anastomosis device 16a, according to one exemplary embodiment. Upon deployment of the first magnetic anastomosis device 16a, the circular fixation mechanism 65 is deployed through the created intestinal incision 63. The circular fixation mechanism 65, which was stored in a compressed position within the access device 14, expands to the deployed configuration as shown in FIG. 11 due to being fabricated from a shape memory material. The circular fixation mechanism 65 engages the distal magnetic anastomosis device 16a and holds the anastomosis device 16a in place against the first tissue wall 26, ensuring accurate placement of the resulting anastomosis. In some alternative embodiments, the fixation mechanism 65 may hold the anastomosis device 16a against both tissue walls 22, 26. The fixation mechanism 65 may remain within the patient after the access device 14 is removed. Over time, the fixation mechanism 65 and anastomotic devices 16a, 16b may fall away from the formed anastomosis and be removed from the patient, or may naturally disappear.

[0060] FIG. 12 illustrates a "petal" fixation mechanism 66 including multiple curved members or springs (e.g., two, three, or more, which may be formed, for example, from a shape memory material or other material) that can be deployed from the side of the intestinal incision 63 opposite the compressed anastomosis device 16a, according to one exemplary embodiment. The "petal" fixation mechanism 66 is stored in a compressed position within the access device 14. Upon delivery of the distal magnetic anastomosis device 16a, the "petal" fixation mechanism 66 is deployed through the created intestinal incision 63. Once deployed, the "petal" fixation mechanism 66 expands to its deployed configuration as shown in FIG. 12 due to the "petal" fixation mechanism 66 being fabricated from a shape memory material. The "petal" fixation mechanism 66 engages the distal anastomosis device 16a and holds the anastomosis device 16a in place against the first tissue wall 26, ensuring accurate placement of the resulting anastomosis. In some alternative embodiments, the fixation mechanism 66 may hold the anastomotic device 16a against both tissue walls 22, 26. The fixation mechanism 66 may remain inside the patient after the access device 14 is removed. Over time, the fixation mechanism 66 and anastomotic devices 16a, 16b may fall away from the formed anastomosis and be removed from the patient, or may naturally fade away.

[0061] FIG. 13 illustrates a fixation mechanism that can be deployed from the side of the intestinal incision opposite the compression anastomosis device, according to one exemplary embodiment, that also includes a ratchet mechanism 67 that allows movement only in the compression direction and prevents any increase in the distance between the compression anastomosis device 16a and the fixation mechanism 67. Upon deployment of the distal magnetic anastomosis device 16a, the ratchet fixation mechanism 67 is deployed through the created intestinal incision 63. The ratchet fixation mechanism 67, which was stored in a compressed configuration within the access device 14, expands to a deployed configuration as shown in FIG. 13. The ratchet fixation mechanism 67 engages the distal anastomosis device 16a and holds the anastomosis device in place against the first tissue wall 26. When the user pulls back on the access device 14, the ratchet mechanism of the ratchet fixation mechanism 67 further compresses the anastomosis device 16a against the tissue wall 26 and allows movement only in the compression direction. In some alternative embodiments, the fixation mechanism 67 may hold the anastomotic device 16a against both tissue walls 22, 26. The fixation mechanism 67 may remain inside the patient after the access device 14 is removed. Over time, the fixation mechanism 67 and anastomotic devices 16a, 16b may fall away from the formed anastomosis and be removed from the patient, or may naturally fade away.

[0062] FIG. 14 illustrates a bulge tube fixation mechanism 68 that expands on either side of the intestinal incision 63 by pulling the two ends toward each other, thereby fixing the compressed anastomosis device 16a at the site of the intestinal incision 63, according to one exemplary embodiment. Upon deployment of the distal anastomosis device 16a, the bulge tube fixation mechanism 68 is deployed through the created intestinal incision 63. The bulge tube fixation mechanism 68, stored in a compressed configuration within the access device 14, expands when the user pulls back on the access device 14, bringing the two ends of the mechanism 68 toward each other in the deployed configuration as shown in FIG. 14. The bulge tube fixation mechanism 68 may automatically assemble into the deployed configuration by being fabricated from a shape memory material. The bulge tube fixation mechanism 68 engages the distal anastomosis device 16a and holds the anastomosis device 16a in place against the first tissue wall 26, ensuring accurate placement of the resulting anastomosis. In some alternative embodiments, the fixation mechanism 68 may hold the anastomotic device 16a against both tissue walls 22, 26. The fixation mechanism 68 may remain inside the patient after the access device 14 is removed. Over time, the fixation mechanism 68 and anastomotic devices 16a, 16b may fall away from the formed anastomosis and be removed from the patient, or may naturally fade away.

[0063] FIG. 15 illustrates a spiral spring fixation mechanism 69 that can be deployed from the opposite side of the intestinal incision 63 from the compressed anastomosis device 16a, according to one exemplary embodiment. Upon deployment of the distal anastomosis device 16a, the spiral spring fixation mechanism 69 is deployed through the created intestinal incision 63. The spiral spring fixation mechanism, which was stored in a compressed configuration within the access device 14, expands to a deployed configuration as shown in FIG. 15 due to being fabricated from a shape memory material. The spiral spring fixation mechanism 69 engages the distal anastomosis device 16a and holds the anastomosis device 16a in place against the first tissue wall 26, ensuring accurate placement of the resulting anastomosis. In some alternative embodiments, the fixation mechanism 69 may hold the anastomosis device 16a against both tissue walls 22, 26. The fixation mechanism 69 may remain within the patient after the access device 14 is removed. Over time, the fixation mechanism 69 and anastomotic devices 16a, 16b may fall away from the formed anastomosis and be removed from the patient, or may naturally disappear.

[0064] Of course, other types of fixation mechanisms are possible in various alternative embodiments, and it should be noted that any fixation mechanism may include a ratchet mechanism that only allows movement in the compression direction and prevents any increase in the distance between the compression anastomosis device and the fixation mechanism.

[0065] Additional exemplary embodiments include devices having a limiting member that sets a maximum separation distance between the two compressed anastomotic devices. The limiting member is rigidly attached and / or in contact with the compressed anastomotic device 16a and receives a connecting member from and / or attaches to the second compressed anastomotic device 16b. Either form of limiting member only allows movement in the direction of compression and prevents any increase in the distance between the two compressed anastomotic devices 16a, 16b. The limiting member may be rotated along a central axis to manipulate the anastomotic devices to align the poles of the pair of anastomotic devices.

[0066] FIG. 16 illustrates a balloon restricting mechanism 70 according to one exemplary embodiment. Upon deployment of the distal and proximal anastomotic devices 16a, 16b, the balloon restricting mechanism 70 is deployed through the formed intestinal incision 63. The balloon restricting mechanism, which was stored in a compressed / contracted configuration during storage within the access device 14, expands / inflates to a deployed configuration as shown in FIG. 16. The balloon restricting mechanism 70 has a distal side and a proximal side, which engage the distal and proximal anastomotic devices 16a, 16b, respectively. Once engaged, the balloon restricting mechanism 70 can only move in a compressive direction to bring the anastomotic devices 16a, 16b together against the tissue walls 22, 26. This ensures accurate placement of the resulting anastomosis. Over time, the restricting mechanism 70 and the anastomotic devices 16a, 16b will fall off the formed anastomosis and be removed from the patient, or will naturally disappear.

[0067] FIG. 17 illustrates a wire array limiting mechanism 71 according to one exemplary embodiment. Upon deployment of the distal and proximal anastomotic devices 16a, 16b, the wire array limiting mechanism 71 is deployed through the formed intestinal incision 63. The wire array limiting mechanism 71, which was stored in a compressed configuration while in the access device 14, expands to the deployed configuration as shown in FIG. 17 due to being fabricated from a shape memory material. The wire array limiting mechanism 71 has distal and proximal ends that engage the distal and proximal anastomotic devices 16a, 16b, respectively. Once engaged, the wire array limiting mechanism 71 can only move in a compressive direction to bring the anastomotic devices 16a, 16b together against the tissue walls 22, 26. This ensures accurate placement of the resulting anastomosis. Over time, the limiting mechanism 71 and anastomotic devices 16a, 16b will fall off the formed anastomosis and be removed from the patient, or will naturally disappear.

[0068] FIG. 18 illustrates a "petal" restraining mechanism 72 including multiple curved members or springs (e.g., two, three, or more than three, which may be formed, for example, from a shape memory material or other material) according to one exemplary embodiment. Upon deployment of the distal and proximal anastomotic devices 16a, 16b, the "petal" restraining mechanism 72 is deployed through the formed intestinal incision 63. The "petal" restraining mechanism 72, which was stored in a compressed configuration, expands to a deployed configuration as shown in FIG. 18 due to being fabricated from a shape memory material. The "petal" restraining mechanism 72 has distal and proximal ends that engage the distal and proximal anastomotic devices 16a, 16b, respectively. Once engaged, the "petal" restraining mechanism 72 can only move in a compressive direction to bring the anastomotic devices 16a, 16b together against the tissue walls 22, 26. This ensures accurate placement of the resulting anastomosis. Over time, the restriction mechanism 72 and anastomotic devices 16a, 16b will either fall away from the formed anastomosis and be removed from the patient, or will naturally disappear.

[0069] FIG. 19 illustrates a bulge tube limiting mechanism 73 according to one exemplary embodiment. Upon deployment of the distal and proximal anastomotic devices 16a, 16b, the bulge tube limiting mechanism is deployed through the formed intestinal incision 63. The bulge tube limiting mechanism 73, which was stored in a compressed configuration while in the access device 14, expands when the user pulls back on the access device 14, bringing the two ends of the mechanism 73 toward each other in the deployed configuration as shown in FIG. 19. The bulge tube limiting mechanism may be fabricated from a shape memory material to automatically configure the deployed configuration. The bulge tube limiting mechanism 73 has a distal end and a proximal end that engage the distal and proximal anastomotic devices 16a, 16b, respectively. Once engaged, the bulge tube limiting mechanism 73 can only move in a compressive direction to bring the anastomotic devices 16a, 16b together against the tissue walls 22, 26. This ensures accurate placement of the resulting anastomosis. Over time, the restriction mechanism 73 and anastomotic devices 16a, 16b will either fall away from the formed anastomosis and be removed from the patient, or will naturally disappear.

[0070] FIG. 20 illustrates a limiting mechanism that also includes a ratchet mechanism 74 that allows movement only in the compression direction and prevents any increase in the distance between the compressed anastomotic device 16a and the fixation mechanism 74, according to one exemplary embodiment. Upon deployment of the distal anastomotic device 16a and the proximal anastomotic device 16b, the ratchet limiting mechanism is deployed through the formed intestinal incision 63. The ratchet limiting mechanism 74, which was stored in a compressed configuration, expands to a deployed configuration as shown in FIG. 20 due to being fabricated from a shape memory material. The ratchet limiting mechanism 74 has a distal end and a proximal end that engage the distal anastomotic device 16a and the proximal anastomotic device 16b, respectively. When engaged, the ratchet limiting mechanism can only move in the compression direction based on the ratchet mechanism in the device. When the user pulls back on the access device 14, the ratchet mechanism allows the device to move only in the compression direction, bringing the anastomotic devices 16a, 16b together against the tissue wall 22, 26. This ensures accurate placement of the resulting anastomosis.Over time, the restraining mechanism 74 and anastomotic devices 16a, 16b will either fall away from the formed anastomosis and be removed from the patient, or will naturally disappear.

[0071] FIG. 21 illustrates a limiting mechanism with suspenders 75 according to one exemplary embodiment. Upon deployment of the distal and proximal anastomotic devices 16a, 16b, the suspender limiting mechanism 75 is deployed through the formed intestinal incision 63. The suspender limiting mechanism 75, which was stored in a compressed position within the access device 14, expands to a deployed configuration as shown in FIG. 21 due to being fabricated from a shape memory material. The suspender limiting mechanism 75 has distal and proximal ends that engage the distal and proximal anastomotic devices 16a, 16b, respectively. Once engaged, the suspender limiting mechanism 75 can only move in a compressive direction to bring the anastomotic devices 16a, 16b together against the tissue walls 22, 26. This ensures accurate placement of the resulting anastomosis. Over time, the limiting mechanism 75 and anastomotic devices 16a, 16b will either fall off the formed anastomosis and be removed from the patient, or will naturally disappear.

[0072] FIG. 22 illustrates a rebar tie limiting mechanism 76 according to one exemplary embodiment. Upon deployment of the distal and proximal anastomotic devices 16a, 16b, the rebar tie limiting mechanism 76 is deployed through the formed intestinal incision 63. The rebar tie limiting mechanism 76, which was stored in a compressed configuration within the access device 14, expands to the deployed configuration as shown in FIG. 22 due to being fabricated from a shape memory material. The rebar tie limiting mechanism 76 has distal and proximal ends that engage the distal and proximal anastomotic devices 16a, 16b, respectively. Once engaged, the rebar tie limiting mechanism can only move in a compressive direction to bring the anastomotic devices 16a, 16b together against the tissue walls 22, 26. This ensures accurate placement of the resulting anastomosis. Over time, the limiting mechanism 76 and anastomotic devices 16a, 16b will either fall off the formed anastomosis and be removed from the patient, or will naturally disappear.

[0073] Of course, other types of limiting mechanisms are possible in various alternative embodiments, and it should be noted that any limiting mechanism may include a ratchet mechanism that only allows movement in the compression direction and prevents any increase in the distance between the compression anastomosis device and the fixation mechanism.

[0074] Incorporation by Reference Throughout this disclosure, references and citations are made to other documents, such as patents, patent applications, patent publications, journals, books, articles, web content, etc. All such documents are hereby incorporated by reference in their entirety for all purposes.

[0075] Equivalent The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The above-described embodiments are therefore to be considered in all respects as illustrative rather than limiting the invention described herein. The scope of the present invention is thus indicated by the appended claims rather than the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

[0076] Potential claims Various embodiments of the present invention may be characterized by the potential claims recited in the paragraph following this paragraph (and preceding the actual claims provided at the end of this application). These potential claims form part of the written description of this application. Accordingly, the subject matter of the following potential claims may be presented as actual claims in a later proceeding, including this application or any application claiming priority based on this application. The inclusion of such potential claims should not be construed to mean that the actual claims do not cover the subject matter of the potential claims. Thus, a decision not to present these potential claims in a later proceeding should not be construed as a donation of that subject matter to the public. Nor are these potential claims intended to limit the various claims that may be pursued.

[0077] Potential subject matter that may be claimed without limitation (prefaced with the letter "P" to avoid confusion with the actual claims set forth below) includes:

[0078] P1. A fixation device for assisting in the placement and fixation of a magnetic compression device at a desired target site within a patient, the fixation device comprising: a button member including a body having a proximal end, an opposed distal end, and a central opening extending generally through said proximal end and said distal end, said opening shaped and / or dimensioned to receive and allow passage of one or more guide members coupled to a first magnetic compression device positioned at a target site relative to a first tissue wall of a hollow body of a patient, said button member configured to move along a length of said one or more guide members toward said target site within said hollow body of the patient; a plug member including a distal end shaped and / or dimensioned to be received within at least a proximal portion of the central opening of the button member and retained therein by a friction fit, thereby fixing the button member in a predetermined position along the length of the one or more guide members; 2. A fixing device comprising:

[0079] P2. The fixation device of claim P1, wherein said proximal end of said button member has an arcuate profile.

[0080] P3. The fixation device of claim P2, wherein said proximal end of said button member has a dome shape.

[0081] P4. The fixation device of claim P1, wherein said distal end of said button member is configured to engage a portion of said first tissue wall of said hollow body of said patient.

[0082] P5. The fixation device of claim P4, wherein the first magnetic compression device is fixed in position against the first tissue wall of the hollow body of the patient when the plug member is positioned within the central opening of the button member to fix the button member in a predetermined position along the length of the one or more guide members.

[0083] P6. The fastening device of claim P5, wherein said button member and said first magnetic compression device are coaxially aligned with one another when said plug member is positioned within said central opening of said button member to secure said button member in a predetermined position along said length of said one or more guide members.

[0084] P7. The fixation device of claim P1, wherein the button member has a diameter less than an inner diameter of the first magnetic compression device when the first magnetic compression device is in a fully deployed configuration.

[0085] P8. The fixation device of claim P1, wherein the button member has a diameter greater than a diameter of an opening formed in the first tissue wall through which the one or more guide members pass.

[0086] P9. The fixation device of claim P1, in which the plug member has a proximal end opposite the distal end.

[0087] P10. The fixation device of claim P9, wherein the distal end of the plug member has a shape and / or contour complementary to a shape and / or contour of at least the proximal portion of the central opening of the button member.

[0088] P11. The fixation device of claim P10, wherein the plug member tapers in width from the proximal end to the distal end.

[0089] P12. The fixation device of claim P11, wherein at least the proximal portion of the central opening tapers in width from a proximal-most opening of the central opening adjacent the proximal end of the button member to a distal-most opening of the central opening adjacent the distal end of the button member.

[0090] P13. The fixation device of claim P10, wherein a cross-sectional shape of the distal end of the plug member corresponds to and complements a cross-sectional shape of at least the proximal portion of the central opening of the button member.

[0091] P14. The fixation device of claim P1, wherein the button member and the plug member each comprise a medical grade material.

[0092] P15. The fixation device of claim P1, wherein the fixation device is shaped and / or dimensioned for endoscopic introduction into the patient.

[0093] P16. The fixation device of claim P1, wherein the fixation device is shaped and / or dimensioned for laparoscopic introduction into the patient.

[0094] A device having deployable self-assembling fixation members comprising a body that holds the position of a compression anastomosis device positioned at a target site against a first tissue wall of a hollow body, said fixation members capturing an intestinal incision and holding said position until a second compression anastomosis device can be coupled to said fixed device.

[0095] P18. The device of claim P17, wherein the fixation member is a balloon fixation member.

[0096] P19. The apparatus of claim P17, wherein the fixing member is a circular fixing member.

[0097] P20. The apparatus of claim P17, wherein the fixing members are "petal" fixing members.

[0098] P21. The apparatus of claim P17, wherein the locking member is a ratchet locking member.

[0099] P22. The apparatus of claim P17, wherein the fixation member is a bulge tube fixation member.

[0100] P23. The apparatus of claim P17, wherein the fastening member is a spiral spring fastening member.

[0101] A device including a limiting member that sets a maximum separation distance between two compressed anastomotic devices, said limiting member being rigidly attached and / or in contact with a compressed anastomotic device and receiving a connecting member from and / or attached to a second compressed anastomotic device. Either form of the limiting member only allows movement in the direction of compression and prevents any increase in the distance between the two compressed anastomotic devices.

[0102] P25. The device of claim P24, wherein the restricting member is a balloon restricting member.

[0103] P26. The apparatus of claim P24, wherein the restricting member is a wire array restricting member.

[0104] P27. The apparatus of claim P24, wherein the restricting member is a "petal" restricting member.

[0105] P28. The apparatus of claim P24, wherein the restricting member is a bulge tube restricting member.

[0106] P29. The apparatus of claim P24, wherein the limiting member is a ratchet limiting member.

[0107] P30. The apparatus of claim P24, wherein the restricting member comprises a suspender.

[0108] P31. The apparatus of claim P24, wherein the restraining member is a rebar bonded restraining member.

Claims

1. 1. A fixation device for assisting in the placement and fixation of an anastomosis device at a desired target site within a patient, the fixation device comprising: a button member including a body having a proximal end, a distal end, and a central opening extending generally through said proximal end and said distal end, said opening shaped and / or dimensioned to receive and pass one or more guide members to permit coupling of said one or more guide members to a first anastomotic device at a target site, said button member movable along said one or more guide members toward said target site within a patient to position said button member relative to an intestinal incision and said first anastomotic device; a plug member including a distal end and an opposed proximal end, the distal end of the plug member shaped and / or dimensioned to be received within and retained within at least a proximal portion of the central opening of the button member, thereby fixing the one or more guide members and the first anastomosis device in place relative to a wall of a tissue and / or organ; 2. A fixing device comprising:

2. The fixation device of claim 1 , wherein the plug member is tapered in width, the proximal end being wider than the distal end.

3. The fixation device of claim 1 , wherein the button member is shaped and / or dimensioned to be positioned between the first and second anastomotic devices.

4. The fixation device of claim 1 , wherein the diameter of the button member is greater than the diameter of the enterotomy.

5. The fixation device of claim 1 , wherein the proximal end has a sloped shape.

6. The fixation device of claim 1 , wherein the proximal end has a dome shape.

7. The fixation device of claim 1 , wherein the distal end of the button member is configured to engage a portion of a first tissue wall of the patient's hollow body.

8. 3. The fixation device of claim 2, wherein at least the proximal portion of the central opening tapers in width from a proximal-most opening of the central opening adjacent the proximal end of the button member to a distal-most opening of the central opening adjacent the distal end of the button member.

9. The fixation device of claim 1 , wherein the button member and the plug member each comprise a medical grade material.

10. The fixation device of claim 2, wherein the button member is shaped and / or dimensioned to be positioned between the first anastomosis device and the second anastomosis device.

11. The fixation device of claim 2, wherein the diameter of the button member is greater than the diameter of the intestinal incision portion.

12. The fixation device of claim 2, wherein the proximal end has a sloped shape.

13. The fixation device of claim 2, wherein the proximal end has a dome shape.

14. The fixation device of claim 2, wherein the distal end of the button member is configured to engage a portion of a first tissue wall of the patient's hollow body.

15. The fixation device of claim 2, wherein the button member and the plug member each comprise a medical grade material.

16. A fixation device as described in claim 1, wherein the plug member secures one or more guide members and prevents the button members from moving along the guide members in a direction away from the anastomosis when the plug member is held by the button member.

17. A fixation device as described in claim 2, wherein the plug member secures one or more guide members and prevents the button members from moving along the guide members in a direction away from the anastomosis when the plug member is held by the button member.

18. The fixation device of claim 1, wherein the button member is centrally positioned relative to the intestinal incision portion and the first anastomosis device.

19. The fixation device of claim 1, wherein the guide member is a guide wire.

20. The fixing device of claim 1, wherein the plug member is retained in the central opening by a friction fit.

21. A method of securing an anastomosis device to a desired target site within a patient using the securement device of claim 1, comprising: delivering the first anastomosis device through the enterotomy to a target site within the patient distal to a wall of a tissue and / or organ, the first anastomosis device being coupled to one or more guide members passing through the enterotomy with a distal end of the button member toward the enterotomy and through a central opening of the button member; moving the button member along one or more guide members toward a target site within a patient to position the button member relative to the intestinal incision and the first anastomotic device such that a distal end of the button member engages a proximal side of a tissue and / or organ wall opposite the first anastomotic device; inserting the plug member into the central opening of the button member to secure one or more guide members with the button member and the first anastomosis device secured against proximal and distal sides of tissue and / or organ walls at a target site, respectively; The method comprising:

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