Anastomosis device equipped with sensors for external sensing and operation

Abstract

A system for placing and tracking one or more magnetic compression anastomosis devices at a desired target site within a patient, comprising: a delivery device including an elongate body having a lumen that extends therethrough and is shaped and / or sized to receive and pass one or more magnetic compression anastomosis devices; one or more magnetic compression anastomosis devices disposed within the lumen; and a tracking device including one or more detectors for detecting the one or more magnetic compression anastomosis devices.

Description

Technical Field

[0001] Cross - Reference to Related Applications This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 353,419, filed on June 17, 2022, entitled "Anastomosis Device with Sensor for Extracorporeal Sensing and Manipulation", the entire content of which is incorporated herein by reference.

[0002] The subject matter of this patent application can be related to the subject matter of U.S. Patent Application No. 17 / 108,840, entitled SYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES (Attorney Docket No. 121326 - 11101), filed on December 1, 2020, which is a continuation - in - part of International Patent Application No. PCT / US2019 / 035202, having an international filing date of June 3, 2019 (Attorney Docket No. 121326 - 11102), and thus claims its priority, and claims the benefit and priority of U.S. Provisional Application No. 62 / 679,810, filed on June 2, 2018, U.S. Provisional Application No. 62 / 798,809, filed on January 30, 2019, and U.S. Provisional Application No. 62 / 809,354, filed on February 22, 2019, the entire content of each of which is incorporated herein by reference.

[0003] The present invention relates to the tracking and retrieval of deployable magnetic compression devices, and more particularly, to improving the accuracy of the position of magnetic compression anastomosis formation between tissues or organs, such as, and tracking the position of the magnetic compression device after completion of the anastomosis procedure, and relates to systems, devices, and methods for detecting the position of the magnetic compression device after delivery, deployment, and positioning of the magnetic compression device at a desired site.

Background Art

[0004] Bypasses of the gastrointestinal (GI) system, cardiovascular system, or urinary system are typically formed by making holes in tissue at two locations and joining the holes with sutures or staples. Bypasses are typically placed to carry fluid (e.g., blood, nutrients) between healthier parts of the system while bypassing diseased or dysfunctional tissue. This procedure is typically invasive, exposing the patient to risks such as bleeding, infection, pain, and adverse reactions to anesthesia. Further, bypasses created with sutures or staples can be complicated by postoperative leaks and adhesions. Leaks can lead to infections or sepsis, while adhesions can lead to complications such as intestinal stricture and obstruction. Conventional bypass procedures can be completed endoscopically, laparoscopically, or robotically, but it can take time to join the holes cut in the tissue. Further, such procedures require specialized expertise and equipment not available at many surgical facilities.

[0005] As an alternative to sutures or staples, a surgeon can use mechanical couplings or magnets to form a compression anastomosis between tissues. For example, a compression coupling or a pair of magnets can be delivered to the tissues to be joined. Due to the strong compression, the tissue trapped between the coupling or magnets is disconnected from its blood supply. Under these conditions, the tissue necroses and degenerates while, at the same time, new tissue grows around the compression point, e.g., at the edges of the junction. Over time, the coupling can be removed, leaving a healed anastomosis between the tissues.

[0006] Nevertheless, the difficulty of placing the magnets or couplings limits the locations where compression anastomosis can be used. In most cases, the magnets or couplings must be delivered as two separate assemblies and require either an open surgical field or a bulky delivery device. For example, existing magnetic compression devices are limited to structures small enough to be deployed with a delivery conduit, such as an endoscopic instrument channel or a laparoscopic port. When these smaller structures are used, the resulting anastomosis is small and subject to short-term patency. Additionally, the placement of the magnets or couplings can be inaccurate, resulting in anastomosis formation at undesirable or inaccurate locations.

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

Summary of the Invention

Problems to be Solved by the Invention

[0008] The present invention provides improved devices and techniques for minimally invasive formation of anastomoses within the body, such as within the gastrointestinal tract. Such devices and techniques facilitate more rapid and less expensive treatment of 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 cancer or colon cancer.

Means for Solving the Problems

[0009] According to one embodiment of the present invention, a system for placing and tracking one or more magnetic compression anastomosis devices at a desired target site within a patient includes a delivery device. The delivery device includes an elongate body having a lumen shaped and / or sized to extend completely therethrough and receive and pass one or more magnetic compression anastomosis devices.

[0010] A system for positioning and tracking one or more magnetic compression anastomosis devices also includes one or more magnetic compression anastomosis devices disposed within a lumen. Each of the one or more magnetic compression anastomosis devices includes a pair of magnetic segments coupled to each other via a flexible outer skeletal element. The one or more magnetic compression anastomosis devices include articulating magnets.

[0011] A system for positioning and tracking one or more magnetic compression anastomosis devices also includes a tracking device that includes one or more detectors that detect the one or more magnetic compression anastomosis devices.

[0012] In some embodiments, the one or more detectors may be external to the patient. The one or more detectors can include a wearable sash worn on the patient's body. The wearable sash can include one or more individual detectors that detect signals. In some embodiments, the one or more detectors can include a detector array that includes one or more individual detectors attached to the patient's body to detect signals. The one or more detectors can detect a magnetic field generated by an articulating magnet. The one or more detectors include individual detectors that include Hall effect measurement devices.

[0013] The one or more magnetic compression anastomosis devices may further include one or more sensors. The one or more sensors can generate an output signal that can be detected by the one or more detectors. The one or more sensors can include at least one wireless transmitter. The output signal can be transmitted to the one or more detectors via wireless communication. The one or more sensors can include at least one of an accelerometer, a piezoresistor, a photovoltaic cell, an infrared sensor, an ambient pressure sensor, a temperature sensor, a pH sensor, a sonic sensor, a humidity sensor, an electromyographic sensor, a magnetic field sensor, a chemical sensor, or a gas sensor.

[0014] One or more detectors may externally detect the presence of a magnetic compression anastomosis device by measuring reflected millimeter wave energy. One or more detectors can externally detect the presence of a magnetic compression anastomosis device using ionizing or non-ionizing radiation.

[0015] In some embodiments, the output of one or more sensors may be collected by a computer system that stores the detected signal. The computer system can provide a display of the output signals of one or more sensors. The display of the output of one or more sensors can be viewed on a handheld device. The handheld device may be at least one of a mobile phone, a tablet computer, or a mobile reading device.

[0016] In some embodiments, at least one magnetic compression anastomosis device can include a wireless receiver. At least one magnetic compression anastomosis device can include one or more actuators that are remotely controlled from a tracking device using wireless communication technology.

[0017] One or more actuators may be configured to perform at least one of controlling the formation of a magnetic compression anastomosis device, controlling two or more magnetic compression anastomosis devices to be brought close to each other, controlling the fitting of two or more magnetic compression anastomosis devices, controlling the separation of two or more magnetic compression anastomosis devices, controlling the joining of two or more magnetic compression anastomosis devices, deploying a joining device, activating an electromagnet, activating a heating element, dispensing a drug, or activating a puncturing or cutting tool.

[0018] The detector can detect that two or more magnetic compression anastomosis devices are joined. The detector can detect that two or more magnetic compression anastomosis devices are separated.

[0019] The distance between two or more magnetic compression anastomosis devices can be determined to decrease as the anastomosis is formed. The distance between two or more magnetic compression anastomosis devices can be used to predict when the device will fall off and / or exit the body.

[0020] A magnetic stack including at least a portion of the tissue compressed between two magnetic compression anastomosis devices can be tracked.

[0021] At least one magnetic compression anastomosis device can include a plurality of articulating magnets.

[0022] The plurality of articulating magnets may be configured to self-assemble from a linear arrangement into a circle or polygon.

[0023] At least one magnetic compression anastomosis device includes a plurality of magnets disposed within an exoskeleton. The exoskeleton can include at least one sensor.

[0024] According to another embodiment of the present invention, a method for placing and tracking one or more magnetic compression anastomosis devices within a patient includes using an elongated body that extends completely therethrough and includes a lumen of such a shape and / or size as to receive and pass one or more magnetic compression anastomosis devices, and a distal portion extending from the elongated hollow body. The distal portion includes a pair of arms extending from the elongated hollow body. Each arm terminates at its respective distal end. Each respective distal end converges with the other to form a substantially integral tip configured to penetrate tissue. The pair of arms cooperatively form a slot in fluid communication with the lumen of the elongated body.

[0025] A method for placing and tracking one or more magnetic compression anastomosis devices within a patient also includes tracking the one or more magnetic compression anastomosis devices using a tracking device. The tracking device includes one or more detectors that detect the one or more magnetic compression anastomosis devices.

[0026] In some embodiments, each of one or more magnetic compression anastomosis devices can further include one or more additional pairs of magnetic segments that are coupled to each other via a flexible exoskeletal element to form a set of articulating magnets. The set of articulating magnets can form a closed geometric shape. The closed geometric shape can be a polygon having at least three sides.

[0027] The tracking device can further include one or more sensors disposed on one or more magnetic compression anastomosis devices. The one or more sensors can generate an output signal that can be detected by one or more detectors. The one or more sensors can include at least one of an accelerometer, a piezoresistor, a photovoltaic cell, an infrared sensor, an ambient pressure sensor, a temperature sensor, a pH sensor, an acoustic sensor, a humidity sensor, an electromyographic sensor, a magnetic field sensor, a chemical sensor, or a gas sensor.

[0028] In some embodiments, one or more detectors can detect the output signal of one or more sensors. The position of one or more magnetic compression anastomosis devices within a patient can be determined from the output signal of one or more sensors.

[0029] In some embodiments, tracking one or more magnetic compression anastomosis devices includes repeatedly determining the position of one or more magnetic compression anastomosis devices within a patient at regular intervals over a given period. The regular intervals can include a first period of from 1 second to 24 hours. The given period can include a second period of from 1 day to 14 days.

[0030] A method for placing and tracking one or more magnetic compression anastomosis devices within a patient can also include determining that one or more magnetic compression anastomosis devices have advanced out of the patient. In some embodiments, the determination can be made if one or more detectors fail to detect any of the one or more magnetic compression anastomosis devices or any of the one or more sensors.

[0031] According to another embodiment of the present invention, a method for anastomosis between tissues of a patient includes the steps of disposing a first magnetic compression anastomosis device adjacent to a first portion of the tissue and disposing a second magnetic compression anastomosis device adjacent to a second portion of the tissue. The method further includes the step of bringing the first magnetic compression anastomosis device and the second magnetic compression anastomosis device closer to each other. The first distance between them when the first magnetic compression anastomosis device and the second magnetic compression anastomosis device are close to each other is from 10 cm to 1 cm.

[0032] The method for anastomosis between tissues of a patient also includes fitting the first magnetic compression anastomosis device and the second magnetic compression anastomosis device together to bring the first portion of the tissue and the second portion of the tissue together, thereby forming a magnetic stack. The distance between them when the first magnetic compression anastomosis device and the second magnetic compression anastomosis device are fitted together is from 10 mm to 2 mm. The first magnetic compression anastomosis device and the second magnetic compression anastomosis device that are fitted surround the first tissue and the second tissue. The magnetic stack includes the first magnetic compression anastomosis device, the first portion of the tissue adjacent to the first magnetic compression anastomosis device, the second portion of the tissue adjacent to the first portion of the tissue, and the second magnetic compression anastomosis device adjacent to the second portion of the tissue. Accordingly, the first and second tissues are compressed between the first and second magnetic compression anastomosis devices.

[0033] The method for anastomosis between tissues of a patient also includes enabling the first magnetic compression anastomosis device and the second magnetic compression anastomosis device within the magnetic stack to necrose and deteriorate the first portion of the tissue and the second portion of the tissue defined thereby. The distance between the first magnetic compression anastomosis device and the second magnetic compression anastomosis device when the first and second tissues have necrosed and deteriorated is from 2 mm to 0.5 mm.

[0034] The method for anastomosis between tissues of a patient further includes enabling the magnetic stack to fall off from the necrosed and decomposed tissues of the patient and exit from the patient.

[0035] The first and second magnetic compression anastomosis devices are articulated. The articulated first and second magnetic compression anastomosis devices are linear or curved.

[0036] The articulated first and second magnetic compression anastomosis devices can form a closed geometric shape. The closed geometric shape may be a polygon having at least three sides.

[0037] The method of anastomosis between tissues of a patient can further include tracking a magnetic stack using a tracking device. The tracking device can further include one or more detectors that detect one or more magnetic compression anastomosis devices. One or more sensors may be disposed on one or more magnetic compression anastomosis devices. One or more sensors can generate an output signal that can be detected by one or more detectors. One or more sensors can include at least one of an accelerometer, a piezoresistor, a photovoltaic cell, an infrared sensor, an ambient pressure sensor, a temperature sensor, a pH sensor, a sound wave sensor, a humidity sensor, an electromyography sensor, a magnetic field sensor, a chemical sensor, or a gas sensor.

[0038] The method of anastomosis between tissues of a patient can further include determining that the magnetic stack has advanced out of the patient. The determination may be made when one or more detectors cannot detect either the magnetic stack or one or more sensors.

[0039] In some embodiments, disposing the first and second magnetic compression anastomosis devices at first and second target sites adjacent to first and second portions of the patient's tissue, respectively, may be based on a visual depiction of the positions of the first and second target sites provided by an imaging modality. The imaging modality can include at least one of a medical imaging procedure, wavelength detection, X-ray based imaging, illumination, computed tomography, X-ray imaging, and fluoroscopy, or a combination thereof. The medical imaging procedure can include ultrasound.

[0040] According to another embodiment of the present invention, the magnetic compression anastomosis device is configured to be delivered into a patient to form an anastomosis within the patient and includes one or more sensors that generate an output signal that can be detected by one or more detectors external to the patient. The one or more sensors can include at least one wireless transmitter, and the output signal is transmitted to the one or more detectors via wireless communication. The one or more sensors can include at least one of an accelerometer, a piezoresistor, a photovoltaic cell, an infrared sensor, an ambient pressure sensor, a temperature sensor, a pH sensor, a sound wave sensor, a humidity sensor, an electromyographic sensor, a magnetic field sensor, a chemical sensor, or a gas sensor.

[0041] The one or more detectors may externally detect the presence of the magnetic compression anastomosis device by measuring reflected millimeter wave energy. The one or more detectors can externally detect the presence of the magnetic compression anastomosis device using ionizing or non-ionizing radiation.

[0042] The output of the one or more sensors may be collected by a computer system that stores the detected signal. The computer system can provide a display of the output signal of the one or more sensors. The display of the output of the one or more sensors can be viewed on a handheld device. The handheld device can include at least one of a mobile phone, a tablet computer, or a mobile reading device.

[0043] At least one magnetic compression anastomosis device can include a wireless receiver. At least one magnetic compression anastomosis device can include one or more actuators that are remotely controlled from a tracking device using wireless communication technology. The one or more actuators can include at least one of controlling the formation of the magnetic compression anastomosis device, controlling two or more magnetic compression anastomosis devices to be close to each other, controlling the fitting of two or more magnetic compression anastomosis devices, controlling the separation of two or more magnetic compression anastomosis devices, controlling the coupling of two or more magnetic compression anastomosis devices, deploying a coupling device, activating an electromagnet, activating a heating element, dispensing a drug, or activating a puncturing or cutting tool.

[0044] The detector can detect that two or more magnetic compression anastomosis devices are coupled. The detector can detect that two or more magnetic compression anastomosis devices are separated.

[0045] The distance between two or more magnetic compression anastomosis devices can be determined. The distance between two or more magnetic compression anastomosis devices may be reduced as the anastomosis is formed. The distance between two or more magnetic compression anastomosis devices can be used to predict when the device will fall off and / or exit the body.

[0046] In some embodiments, a magnetic stack including at least a portion of the tissue compressed between two magnetic compression anastomosis devices can be tracked.

[0047] At least one magnetic compression anastomosis device includes a plurality of articulating magnets. The plurality of articulating magnets may be configured to self-assemble from a linear arrangement into a circle or polygon. At least one magnetic compression anastomosis device can include a plurality of magnets disposed within an exoskeleton. The exoskeleton can include at least one sensor.

[0048] More specifically, the present invention provides various systems, devices, and methods for detecting the position of a magnetic compression anastomosis device after delivery, deployment, and positioning of the magnetic compression anastomosis device at a desired site in order to improve the accuracy of anastomosis formation between tissues or organs such as the gallbladder. Further, the present invention provides for the tracking of a magnetic compression anastomosis device through a patient's body until the magnetic device is removed. The systems, devices, and methods of the present invention include, but are not limited to, various access devices for accessing a patient's hollow body such as the gallbladder, and ensure the positioning of the access device for the subsequent placement of one of a pair of magnetic anastomosis compression devices and the accurate detection of the position of the magnetic device. The systems, devices, and methods of the present invention further include various delivery devices for delivering at least one of a pair of magnetic anastomosis compression devices to a target site, and in some cases, the delivery devices consistent with the present disclosure can assist in the deployment of at least one of a pair of magnetic anastomosis compression devices, and subsequent fixation to the target site, and / or the coupling of the pair of magnetic anastomosis compression devices to each other. The systems, devices, and methods of the present invention include various embodiments of magnetic anastomosis compression devices, and generally various designs for transitioning from a compact delivery configuration to a larger deployment configuration by self-assembly design.

[0049] For example, in one aspect, the present invention provides a system including a delivery device for introducing and delivering a pair of magnetic assemblies between adjacent organs via minimally invasive techniques to bridge the tissue walls of each organ to each other, thereby forming a passageway (i.e., anastomosis) therebetween. The delivery device is particularly useful for delivering a pair of magnetic assemblies to a target site within the gastrointestinal tract, thereby forming an anastomosis between the walls of the stomach and the gallbladder to provide appropriate drainage from the gallbladder when an obstruction has occurred (due to a disease or other health-related problem).

[0050] In the embodiments described herein, the system generally includes a single scope such as an endoscope, laparoscope, catheter, trocar, or other access device through which a delivery device advances to a target site and a pair of magnetic assemblies are delivered and positioned to form an anastomosis at the target site. In particular, the delivery device includes an elongate hollow body such as a catheter having a shape and / or size that conforms within a range. The delivery device includes a working channel into which a pair of magnetic assemblies are loaded. The delivery device further includes a distal end configured to penetrate or otherwise pass through tissue. For example, the distal end may have a sharp tip for piercing tissue and / or may utilize energy to pass through tissue (i.e., hot tip). The body of the delivery device further includes a slot or opening adjacent the distal tip. The slot is shaped and / or sized to receive the magnetic assembly such that the magnetic assembly passes through the working channel and exits the delivery device through the slot. The delivery device further includes a deployment member, generally in the form of a wire, releasably coupled to one or both of the magnetic assemblies and providing means for deploying the magnetic assembly from the distal end of the delivery device through the slot.

[0051] During the procedure, a surgeon or other trained medical professional can advance a scope (e.g., an endoscope) within a patient's hollow body and position the scope at a desired anatomical location for anastomosis formation based on a visual depiction of the location of the target site as provided by an imaging modality that provides a medical imaging procedure (e.g., ultrasound (US), wavelength detection, X-ray based imaging, illumination, computed tomography (CT), radiography, and fluoroscopy, or combinations thereof). The surgeon can advance the distal tip of the delivery device through the adjacent walls of a pair of organs (i.e., through the wall of the duodenum and the wall of the common bile duct). Once the distal end including the slot is advanced into the first organ (i.e., the common bile duct), the surgeon can utilize the placement member to manually deliver and deploy the first magnetic assembly into the first organ through the slot. Each magnetic assembly generally includes a pair of magnetic segments that are arranged linearly aligned with each other (e.g., aligned end-to-end) and are coupled to each other via a flexible outer skeletal element, and it should be noted that the segments are spaced apart via the central portion of the outer skeleton. The outer skeleton may be made of an elastic material that retains its shape after deformation, such as a polymer or a metal alloy. Thus, when the first magnetic assembly is deployed, the pair of magnetic segments exit from slots on respective opposite sides of the body of the delivery device, but the central portion of the outer skeleton remains within the slot. In other words, the slot extends completely through the body of the delivery device from one side to the other side.

[0052] At this point, the surgeon need only pull back the delivery device until the first magnetic assembly engages the tissue of the first organ and most of the slot is disposed within the second organ. The surgeon can then deliver and deploy the second magnetic assembly to the second organ (i.e., the duodenum). The second magnetic assembly deploys in a similar manner as the first magnetic assembly in that the magnetic segments of the second magnetic assembly exit the slot on opposite respective sides of the body of the delivery device while the central portion of the outer skeleton remains within the slot. Next, the first and second magnetic assemblies are substantially aligned with each other and, by the attractive magnetic force, the first and second magnetic assemblies are coupled to each other. The distal end of the delivery device includes two halves that form a relatively uniform tip shape when in the default state. However, the distal end includes a deformable material (i.e., a shape memory material) such that when sufficient force is applied, the two halves separate. Thus, once both the first and second magnetic assemblies are delivered and effectively coupled to each other (but still retained within the slot), the surgeon need only pull back the delivery device, whereby the magnets contact the distal tip and the two halves of the distal tip are pushed apart, enabling the distal end of the delivery device to be withdrawn from the target site while the pair of magnetic assemblies remain in place. The pair of magnetic assemblies compress the wall of each organ therebetween and subsequently form an anastomosis between the organs (i.e., an anastomosis between the duodenum and the common bile duct).

[0053] Thus, upon deployment, each magnetic assembly has a width and length that generally correspond to the width of each segment and a length that is approximately twice the length of each segment. As a result, when a pair of magnetic assemblies are coupled together, they generally form a substantially linear package, and the resulting anastomosis may generally be rectangular in shape but may also naturally form a circular or oval shape. The resulting anastomosis can have an aspect ratio of 1:1 with respect to the dimensions of the magnetic assembly. However, the present invention enables a larger aspect ratio (i.e., a larger anastomosis formed with respect to the dimensions of the magnetic assembly). In particular, prior art systems and methods that involve the use of magnets to form anastomoses are generally limited based on the dimensions of the working channel of the scope or catheter used to deliver such magnets, thereby limiting the size of the resulting anastomosis. However, the magnetic assembly design of the present invention overcomes such limitations. For example, the design of the magnetic assemblies of the present invention, particularly the coupling of multiple magnetic segments via an outer skeleton, allows any number of segments to be included in a single assembly, and thus the resulting anastomosis has a larger size with respect to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomosis can have an aspect ratio in the range of 2:1 to 10:1 or greater.

[0054] Thus, the delivery device of the present disclosure generates a thin linear anastomosis that enables the reduction of certain complications, particularly those associated with common bile duct obstruction.

[0055] The features and advantages of the claimed subject matter will become apparent from the following detailed description of the embodiments that coincide therewith, which description should be considered in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0056]

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[0057] To fully understand the present disclosure, reference should be made to the following detailed description, including the appended claims, in relation to the above drawings. The present disclosure is described in relation to exemplary embodiments, but the present disclosure is not intended to be limited to the specific forms described herein. It is understood that various omissions and substitutions of equivalents are contemplated as the circumstances may suggest or render expedient.

[0058] Exemplary embodiments provide improved devices and techniques for minimally invasive formation of anastomoses within the body, such as within the gastrointestinal tract. Such devices and techniques facilitate more rapid and less expensive treatment of 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 cancer or colon cancer.

[0059] The system is generally provided within a patient's hollow body and includes an access device configured to assist in forming an anastomosis at a target site (desired anatomical location) within the hollow body to form an anastomosis between a first portion of the tissue of the hollow body and a second portion of the tissue of the hollow body at the target site. The access device provides access to the first and second portions of the tissue of the hollow body and further is configured to deliver and position a first implantable magnetic anastomosis device and a second implantable magnetic anastomosis device with respect to the first and second portions of the tissue or adjacent tissue to form an anastomosis between the tissues at the target site. The first and second implantable magnetic anastomosis compression devices are magnetically attracted to each other through a defined tissue region of the total thickness of the wall of the tissue at the target site and are configured to apply a compressive force to the defined region to form an anastomosis.

[0060] The systems, devices, and methods described herein include, without limitation, various access devices for accessing a patient's hollow body, such as the gallbladder, and ensure positioning of the access device for subsequent placement of one of a pair of magnetic anastomosis compression devices. The systems, devices, and methods described herein further include various delivery devices for delivering at least one of a pair of magnetic anastomosis compression devices to a target site, and in some cases, the delivery devices consistent with the present disclosure can assist in deployment of at least one of a pair of magnetic anastomosis compression devices, and subsequent fixation to the target site, and / or coupling of the pair of magnetic anastomosis compression devices to each other. The systems, devices, and methods described herein include various embodiments of magnetic anastomosis compression devices and various designs for transitioning from a compact delivery configuration to a larger deployment configuration, generally by a self-assembling design.

[0061] More specifically, an exemplary embodiment provides a system including a delivery device for introducing and delivering a pair of magnetic assemblies between adjacent organs via minimally invasive techniques to cross-link the tissue walls of each organ to each other, thereby forming a passage (i.e., an anastomosis) therebetween. The delivery device is particularly useful for delivering a pair of magnetic assemblies to a target site within the gastrointestinal tract, thereby forming an anastomosis between the walls of the stomach and the gallbladder to provide proper drainage from the gallbladder when an obstruction has occurred (due to a disease or other health-related problem).

[0062] The systems, devices, and methods described herein include, but are not limited to, various method systems and devices for positioning, placing, and tracking a deployed magnetic compression anastomosis device. Additionally or alternatively, one or more sensors can be included as part of the magnetic compression anastomosis device to detect and / or generate signals that can be transmitted to an external device (e.g., a detector).

[0063] Accordingly, an exemplary embodiment provides improved devices and techniques for minimally invasive formation of anastomoses within the body, e.g., within the gastrointestinal tract. Such devices and techniques facilitate more rapid and less expensive treatment of chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, e.g., gastric cancer or colon cancer.

[0064] FIG. 1 is a schematic diagram of a system 10 for positioning and tracking one or more magnetic compression anastomosis devices to provide an improved placement of a magnetic anastomosis device (e.g., a magnetic compression anastomosis device) at a desired site to improve the accuracy of anastomosis generation between tissues within a patient 12. System 10 generally includes an access device 14, delivery devices 15, 100, a magnetic anastomosis compression device 16, 200, an imaging modality 18, one or more detectors 13, and one or more sensors 17.

[0065] The access device 14 can generally include, but is not limited to, a scope including an endoscope, a laparoscope, a catheter, a trocar, or other delivery device. In most of the applications described herein, the access device 14 is an endoscope that includes a delivery needle configured to deliver the magnetic anastomosis devices 16, 200. Thus, the system 10 of the present disclosure relies on a single endoscope 14 for the delivery of two magnetic compression devices 16, 200. As will be described in more detail herein, a surgeon can advance the endoscope 14 within the hollow body of the patient 12 and position the endoscope 14 at a desired anatomical location to form an anastomosis based on the visual depiction of the location of the target site provided by the imaging modality. For example, the imaging modality can include a display on which an image or other visual depiction is presented to the surgeon indicating the target site when performing a medical imaging procedure 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 depictions when advancing the endoscope through the hollow body to position the access device 14 at a portion of the tissue adjacent to another portion of the tissue at the target site, thereby ensuring that the placement of the magnetic devices 16, 200 is accurate.

[0066] The anastomosis forming system 10 may further include one or more detectors 13 for detecting the presence and location of a magnetic anastomosis. Thus, certain exemplary embodiments include an extracorporeal device that is capable of detecting the presence or absence of a magnetic compression anastomosis device within the body and optionally detecting the location of the magnetic compression anastomosis device within the body and / or detecting any of a variety of types of parameters associated with the magnetic compression anastomosis device and / or the body.

[0067] In some cases, the sensing of the magnetic compression anastomosis device within the body can be performed without adding additional functions to the magnetic compression anastomosis device, such as detecting the magnetic field or magnetic flux generated by the magnetic compression anastomosis device. The detection of such a magnetic field or magnetic flux can be achieved by using a Hall sensor or other magnetic field sensors or magnetometers. Further, the magnetic compression anastomosis device itself may be detected using a metal detector, transmitting millimeter-wave energy to detect the reflected millimeter-wave energy, transmitting ionizing or non-ionizing radiation to detect the reflected energy, or stimulating and detecting magnetic resonance, such as by using magnetic resonance imaging.

[0068] Additionally or alternatively, one or more sensors can be included as part of the magnetic compression anastomosis device to generate signals that can be detected and / or transmitted to an external device. For example, any of various wireless communication technologies such as devices having near-field communication (NFC) technology, radio frequency identification (RFID) technology, and / or Bluetooth technology are used. The external device can be configured to detect and receive signals from any of the above wireless communication devices.

[0069] Note that the hollow body through which the access device 14 can pass includes, but is not limited to, the stomach, gallbladder, pancreas, duodenum, small intestine, large intestine, intestine, and the vascular system including veins and arteries.

[0070] In some embodiments, a self-assembling magnetic device is used to form a bypass in the gastrointestinal tract. Such meshes can be used even for the treatment of cancerous obstructions, weight loss or obesity, or the treatment of diabetes and metabolic diseases (i.e., bariatric surgery). FIG. 2 shows various gastrointestinal anastomosis targets that can be addressed with the device of a particular exemplary embodiment, such targets including from the stomach to the small intestine (A), from the stomach to the large intestine (E), from the small intestine to the small intestine (C), from the small intestine to the large intestine (B), and from the large intestine to the large intestine (D). Accordingly, the exemplary embodiments provide improved devices and techniques for minimally invasive formation of anastomoses within the body, e.g., within the digestive tract. Such devices and techniques facilitate more rapid and less expensive treatment of chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, e.g., gastric cancer or colon cancer.

[0071] For example, if the hollow body through which access device 14 can pass is the patient's intestine, the first portion can be the distal portion of the intestine and the second portion can be the 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 to reduce or prevent other diseases such as diabetes, hypertension, autoimmune, or musculoskeletal diseases. Note that the system may be used for the formation of an anastomosis (e.g., a portal between the stomach and the gallbladder, the duodenum and the gallbladder, the stomach and the small intestine, the small intestine and the large intestine, the stomach and the large intestine, etc.) between the first portion of the tissue of the hollow body at the target site and the adjacent tissue of the second hollow body.

[0072] In endoscopic procedures, a self - assembling magnetic device can be delivered using a single endoscope 14. The deployment of the magnetic device 16 is shown generally in FIG. 3. As shown, an exemplary magnetic anastomosis device 16 may be delivered through the endoscope 14 such that the individual magnet segments self - assemble into a larger magnetic structure, in this particular case an octagon. In some embodiments, the self - assembling magnets are articulating and can reassemble into a polygonal structure such as a circle, an ellipse, a square, a hexagon, an octagon, a decagon, or other geometric structures forming a closed loop. Further, the magnets may be deployed in a straight or curved configuration. In embodiments, the self - assembling articulating magnets may be arranged in a closed geometric shape that is a polygon having at least three sides.

[0073] When used with the techniques described herein, the device 16 enables the delivery of a larger magnetic assembly than would be possible through a small delivery conduit such as a standard endoscope when the device is deployed as a completed assembly. Further, the larger magnet structure enables the formation of a more robust and larger anastomosis, achieving greater surgical success. For example, in some cases, the resulting anastomosis can have an aspect ratio of 1:1 with respect to the final dimensions of the assembled magnetic device. However, the exemplary embodiments enable a larger aspect ratio (i.e., a larger anastomosis formed with respect to the dimensions of the magnetic assembly). In particular, prior art systems and methods that involve the use of magnets to form an anastomosis are generally limited based on the dimensions of the working channel of the scope or catheter used to deliver such magnets, thereby limiting the size of the resulting anastomosis. However, the magnetic assembly design of the exemplary embodiments overcomes such limitations. For example, the design of the magnetic assembly, particularly the coupling of multiple magnetic segments via an exoskeleton, allows any number of segments to be included in a single assembly, and thus the resulting anastomosis can have a larger size with respect to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomosis can include an aspect ratio in the range of 2:1 to 10:1 or greater.

[0074] Since the magnetic device is radiopaque and echogenic, the device can be positioned using fluoroscopy, direct visualization (e.g., transillumination or tissue injection), and ultrasound, such as an endoscopic ultrasound. The device 16 can also be decorated with a radiopaque paint or other marker to assist in identifying the polarity of the device during placement.

[0075] The magnetic anastomosis device 16 generally includes magnetic segments that can assume a delivery conformation and a deployed configuration. The delivery conformation is typically linear so that the device can be delivered to tissue through a laparoscopic "keyhole" incision or through a natural passageway, such as through the esophagus, using an endoscope 14 or similar device. Further, the delivery conformation is typically somewhat flexible so that the device can be guided through various curvatures within the body. Once the device is delivered, the device assumes a deployed configuration of a desired shape and size by automatically converting from the delivery conformation to the deployed configuration. The self-conversion from the delivery conformation to the deployed configuration is guided by a coupling structure that moves the magnetic segments in a desired manner without intervention. Exemplary self-assembling magnetic anastomosis devices 16, such as self-closing, self-opening, etc., are described in U.S. Patent Nos. 8,870,898, 8,870,899, 9,763,664, and 10,182,821, the contents of each of which are hereby incorporated by reference in their entirety.

[0076] As shown in FIG. 4A, generally, the magnetic anastomosis procedure includes placing first and second magnetic assemblies 16a, 16b adjacent to first and second portions 20, 24 of tissue 22, 26, respectively, thus bringing the tissues 22 and 26 together. When the two devices 16a, 16b are brought into proximity, the magnetic assemblies 16a, 16b mate and bring the tissues 22, 26 together. Over time, an anastomosis of the size and shape of the devices 16a, 16b is formed and the devices fall off the tissue. In particular, the tissues 22, 26 surrounded by the device necrose and degrade, providing an opening between the tissues.

[0077] Alternatively, the fitting devices 16a and 16b generate sufficient compressive force to stop blood flow to the tissues 22, 26 captured between the devices, so that the surgeon can form an anastomosis by incising the tissues 22, 26 surrounded by the devices, as shown in FIG. 4B.

[0078] FIG. 4C shows a side view of a magnetic anastomosis procedure including placing the first and second magnetic assemblies 16a, 16b adjacent to the first and second portions of the tissues 22, 26, respectively, and thus bringing the tissues 22 and 26 together. FIGS. 4C-4E also show the side walls 21, 25 of adjacent channels that will be joined in the anastomosis procedure to form a new channel. In FIG. 4C, the two devices 16a, 16b are brought close together. In some embodiments, the distance Dx between them when the two devices 16a, 16b are close can be from 10 cm to 1 cm. In some embodiments, the distance Dx is from 8 cm to 3 cm.

[0079] FIG. 4D shows a side view of the magnetic anastomosis procedure after the magnetic assemblies 16a, 16b are fitted. The fitting of the two magnetic assemblies (e.g., magnetic compression anastomosis devices) brings the tissues 22, 26 together and surrounds the tissues 22, 26. The tissues 22, 26 are tightly compressed along the surface between the magnetic assemblies 16a, 16b. In some embodiments, the distance Dy between the two devices 16a, 16b when fitted can be from 10 mm to 1 mm. In some embodiments, the distance Dy is from 8 mm to 3 mm.

[0080] When the magnetic assemblies 16a, 16b fit with the compressed tissue 23 therebetween, a magnetic stack 27 is formed. The magnetic stack includes the tissues 22, 26 compressed together between the fitted magnetic assemblies 16a, 16b.

[0081] Over time, a conformity in the size and shape of the magnetic devices 16a, 16b is formed and the devices fall off the tissue. In particular, the compressed tissue 27 surrounded by the magnetic devices 16a, 16b necroses and decomposes, providing an opening between the tissues. At the same time, the side walls 21, 25 of adjacent channels that are joined in the conforming procedure to form a new channel.

[0082] Figure 4E shows a side view of the magnetic conforming procedure after the tissues 22, 26 have necrosed, deteriorated, and fallen off. The magnetic stack 27 is shown moving downward through the patient's digestive tract. The side walls 21, 25 of adjacent channels are joined to complete the conforming procedure and create a new channel, as indicated by the arrows.

[0083] As the magnetic stack attempts to fall, the distance between the magnetic devices 16a, 16b, Dz can be from 10 mm to 1 mm. In some embodiments, the distance Dz is from 2 mm to 0.5 mm. In some embodiments, the distance Dz is from 1.5 mm to 0.75 mm.

[0084] The change in the distance between the magnetic devices 16a, 16b can be used as an indicator of the progress of the conforming procedure. That is, as the distance narrows from Dx when the magnetic devices are brought close together, through the distance Dy when the magnetic devices are fitted, to the distance Dz when the magnetic devices fall off, the distance between the magnetic devices narrows such that Dx > Dy > Dz. In some embodiments, the time of the fall of the magnetic stack corresponding to the opening of the conforming can be predicted from the rate of narrowing of the distance D as well as the thickness of D.

[0085] The figures and structures of the present disclosure relate primarily to circular or polygonal structures, but it should be understood that various deployable magnetic assemblies can be fabricated using the delivery and construction techniques described herein. For example, self - assembling magnets can reassemble into polygonal structures such as circles, ellipses, squares, hexagons, octagons, decagons, or other geometric structures that form closed loops. The device can further include handles, suture loops, barbs, and protrusions as needed to achieve the desired performance and to facilitate delivery (and removal). Additionally, in other embodiments such as the magnetic assembly 200 of FIG. 6, the magnetic assembly can include a pair of magnetic segments that are generally linearly aligned with each other (e.g., aligned end - to - end) and coupled to each other via a flexible exoskeletal element.

[0086] As described above, the self - assembling magnetic anastomosis device can be delivered to the target site via the access device 14. For example, as shown in FIG. 5A, the access device 14 can include a delivery needle 28 (e.g., a suction needle) used to deliver the first magnetic anastomosis device 16a to the lower small intestine (by puncture), and then the second magnetic device 16b is deployed to the upper small intestine at a position on the tissue adjacent to the target site (shown in FIG. 5B). Note that the delivery can be guided by fluoroscopy or endoscopic ultrasound. Following self - organization, these small intestine magnetic devices 16a, 16b couple to each other (e.g., are magnetically attracted to each other) through a defined tissue region of the total thickness of the tissue wall at the target site and apply a compressive force to the defined region to form an anastomosis.

[0087] FIG. 6 shows a perspective view of another embodiment of a magnetic assembly 200 consistent with the present disclosure. The magnetic assembly 200 generally includes a pair of magnetic segments 202, 204 that are linearly aligned with each other (e.g., aligned end-to-end) and coupled to each other via a flexible outer skeletal element 206. The segments 202, 204 are spaced apart via a central portion 108 of the outer skeleton 206. The central portion 208 can include a connection member for receiving a corresponding connection member of a placement device to assist in the delivery of the magnetic assembly 200. The outer skeleton may be made of an elastic material that retains its shape after deformation, such as a polymer or a metal alloy. In some embodiments, the metal alloy includes nickel, such as nitinol. Exemplary outer skeleton 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 hereby incorporated by reference in their entirety.

[0088] The magnetic assembly 200 is configured to be delivered and deployed to a target site via a delivery device 15. As described above, exemplary embodiments provide improved devices and techniques for minimally invasive formation of anastomoses within the body, e.g., within the gastrointestinal tract. Such devices and techniques facilitate more rapid and less expensive treatment of chronic diseases such as obesity and diabetes. Such techniques also reduce the time and pain associated with palliative treatment of diseases such as cancer, e.g., gastric or colon cancer. More specifically, exemplary embodiments provide 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 the tissue walls of each organ to each other, thereby forming a passageway (i.e., an anastomosis) therebetween. The delivery device 15 is particularly useful for delivering a pair of magnetic assemblies to a target site within the gastrointestinal tract, thereby forming an anastomosis between the walls of the stomach and the gallbladder to provide proper drainage from the gallbladder when an obstruction has occurred (due to a disease or other health-related problem).

[0089] When deployed, each magnetic assembly has a width and length that generally correspond to the width of each segment and a length that is approximately twice the length of each segment. As a result, when a pair of magnetic assemblies are coupled together, they generally form a substantially linear package, and the resulting anastomosis may generally be rectangular in shape but may also naturally form a circular or oval shape. The resulting anastomosis can have an aspect ratio of 1:1 with respect to the dimensions of the magnetic assembly. However, exemplary embodiments allow for a larger aspect ratio (i.e., a larger anastomosis formed with respect to the dimensions of the magnetic assembly). In particular, prior art systems and methods that involve the use of magnets to form an anastomosis are generally limited based on the dimensions of the working channel of the scope or catheter used to deliver such magnets, thereby limiting the size of the resulting anastomosis. The magnetic assembly design overcomes such limitations.

[0090] For example, the design of the magnetic assembly, particularly the coupling of multiple magnetic segments via an exoskeleton, allows any number of segments to be included in a single assembly, and thus the resulting anastomosis has a larger size with respect to the dimensions of the working channel of the scope. For example, in some embodiments, the resulting anastomosis can include an aspect ratio in the range of 2:1 to 10:1 or greater. As described above, the anastomosis can include a substantially two-dimensional shape. That is, the magnetic assembly can take on a polygonal shape having three or more sides up to an octagon (e.g., an eight-sided polygon 16 as shown in FIG. 3).

[0091] Accordingly, the delivery device of the present disclosure provides a thin anastomosis that enables the reduction of specific complications, particularly those associated with common bile duct obstruction. In particular, patients experiencing common bile duct obstruction often undergo some procedure to remove the obstruction or enable drainage to reduce jaundice / infection and portal vein complications. Common procedures are sphincterotomy or some type of drainage stent placement procedure. Conventional methods present decompression of the bile duct, but there are procedures that are not possible with minimally invasive methods. Such procedures include, for example, sphincterotomy that is not possible because a cannula cannot be inserted into the common bile duct, particularly during severe disease states where anatomical changes cannot be accounted for. Utilizing the magnetic closing force profile described herein enables minimal bleeding and creates a semi-permanent slit profile. This slit profile helps to resist the "septic tank syndrome" and helps to form a drainage point that remains effectively infection-free.

[0092] Generally speaking, a magnetic compression anastomosis device is designed and intended to be discharged from the body, such as after an anastomosis is formed and the device is separated from the tissue. It can be very important to monitor a magnetic compression anastomosis device and be able to prove that the magnetic compression anastomosis device is no longer in the body. For example, without such proof, a person can be prohibited from performing a magnetic resonance imaging (MRI) procedure that can be harmful to the patient and others if the device is still in the body. It can also be important to detect that a magnetic compression anastomosis device is abnormally retained in the body, which can suggest, for example, improper formation of the anastomosis or other problems (such as an obstruction preventing drainage).

[0093] Accordingly, certain exemplary embodiments include an external device that is capable of detecting the presence or absence of a magnetic compression anastomosis device in the body, optionally detecting the location of the magnetic compression anastomosis device in the body, and / or sensing any of a variety of types of parameters associated with the magnetic compression anastomosis device and / or the body. FIG. 7 is a schematic diagram conceptually showing such an external device 13 (herein referred to as a "detector") that determines the location and / or presence of a magnetic compression anastomosis device 16 in the body.

[0094] In some cases, the detection of the magnetic compression anastomosis device 16 in the body can be performed without adding additional functions to the magnetic compression anastomosis device, for example, by detecting a magnetic field or magnetic flux generated by the magnetic compression anastomosis device (e.g., using a Hall sensor or other magnetic field sensor or magnetometer), or by detecting the magnetic compression anastomosis device itself (e.g., using a metal detector to transmit millimeter-wave energy and detect the reflected millimeter-wave energy, transmitting ionizing or non-ionizing radiation and detecting the reflected energy, or stimulating and detecting magnetic resonance by using magnetic resonance imaging, etc.).

[0095] Additionally or alternatively, one or more sensors 17 can be included as part of the magnetic compression anastomosis device 16 to generate signals that can be detected and / or transmitted to an external device using any of various wireless communication technologies, such as short-range wireless communication technology. FIG. 8 is a schematic diagram conceptually showing an internal sensor 17 that determines and transmits the position and / or presence in the body in this example. Without limitation, the sensor can include some or all of the following.

[0096] For example, an accelerometer used to determine the absolute or relative position of a device in the body or to detect the movement of a device that can be used to match the waveform of motility to the position in the body.

[0097] For example, a force sensor (e.g., a piezoresistor or a piezoelectric sensor) for detecting a force exerted on the magnetic compression anastomosis device due to the coupling or separation of the magnetic compression anastomosis device (e.g., including the strength of the coupling), a force exerted on the magnetic compression anastomosis device due to muscle contraction or tissue swelling, or a force received when the magnet exits the body.

[0098] For example, a light sensor (e.g., a photovoltaic cell or a camera) for detecting visible light levels in the body or for capturing an image or video of a magnetic compression anastomosis device or surrounding structures within the body can include a light source to provide illumination for capturing the image or video.

[0099] For example, an infrared (IR) sensor for detecting IR light levels and changes in IR light levels within the body.

[0100] For example, a pressure sensor for detecting changes in internal pressure and pressure over time and when the device moves through different parts of the body.

[0101] For example, a thermometer for detecting the body temperature at or near the location of the magnetic compression anastomosis device. This can be used for both medical purposes (e.g., to detect a fever that may be caused by an infection) and to determine whether the magnetic compression anastomosis device has exited the body (e.g., detecting a temperature within the normal body temperature range may suggest that the device is still within the body, while detecting a lower temperature may suggest that the device has moved away from the body).

[0102] For example, a pH sensor for detecting pH levels and changes in pH levels over time and when the device moves through different parts of the body.

[0103] For example, an acoustic sensor for detecting acoustic signatures and changes in acoustic signatures over time and when the device moves through different parts of the body.

[0104] For example, a humidity sensor for detecting humidity levels (e.g., water vapor) and changes in humidity levels over time and when the device moves through different parts of the body.

[0105] For example, a gas sensor for detecting gas profiles and changes in gas profiles over time and when the device moves through different parts of the body.

[0106] For example, an electrical sensor (e.g., an electromyogram test or an EMG sensor) for detecting contact with a lumen wall, loss of contact, or quality of contact.

[0107] For example, a heartbeat sensor for detecting the presence of a heartbeat, absence of a heartbeat, or heart rate.

[0108] A blood pressure sensor.

[0109] A blood flow or oxygenation sensor.

[0110] For example, a chemical sensor for detecting any of a variety of chemicals and gases, such as in blood or within a lumen.

[0111] For example, a biological sensor for detecting the presence of any of a variety of pathogens that may cause infection or disease.

[0112] For example, a magnetic field sensor (e.g., a Hall sensor or other magnetic field sensor or magnetometer) for sensing a magnetic field generated by a magnetic compression anastomosis device and / or other magnetic or electromagnetic device used to operate a magnetic compression anastomosis device either from within or outside the body.

[0113] Additionally or alternatively, other types of active devices and / or sensors including active devices that can be remotely controlled from an external device or by an external device can be included in the magnetic compression anastomosis device. For example, without limitation, the active device can provide remote operation, tissue stimulation or manipulation, drug delivery, tissue harvesting / sampling, ablation, etc. of the magnetic compression anastomosis device during and / or after deployment. Further, the active device can include a magnetic compression anastomosis device that provides proximity information regarding the distance between two adjacent magnetic assemblies. That is, an active device capable of determining the distance D between two magnetic assemblies deployed to form an anastomotic opening.

[0114] The active devices included in the magnetic compression anastomosis device can be powered in various ways, such as, for example, but not limited to, a battery (which may be rechargeable wirelessly from outside the body), an electromagnetic field transmitted by an external device or other external device (e.g., using RFID or magnetoelastic power generation), or an included fuel cell (e.g., a fuel cell powered by a body fluid such as a glucose-containing body fluid).

[0115] The active devices included in the magnetic compression anastomosis device can include other electronic circuits such as a microcontroller and / or a wireless transmitter and / or receiver circuit. The magnetic compression anastomosis device can include one or more actuators that are remotely controlled by a tracking device. The tracking device and the actuators and / or sensors can communicate bidirectionally such that each of the tracking device and the actuators and / or sensors can transmit or receive commands (e.g., control).

[0116] The actuator can be configured to control the formation of the magnetic compression anastomosis device, to control bringing two or more magnetic compression anastomosis devices close to each other, to control the fitting of two or more magnetic compression anastomosis devices, to control the coupling of two or more magnetic compression anastomosis devices, to control the connection of two or more magnetic compression anastomosis devices, to deploy a coupling device, to activate an electromagnet, to activate a heating element, to dispense a chemical substance, or to activate a piercing or cutting tool.

[0117] The detector can detect that two or more magnetic compression anastomosis devices are coupled. The detector can detect that two or more magnetic compression anastomosis devices are separated.

[0118] The distance between two or more magnetic compression anastomosis devices can be determined such that the distance between the two or more magnetic compression anastomosis devices decreases as the anastomosis is formed. The distance between two or more magnetic compression anastomosis devices can be used to predict when the device will fall off and / or exit the body.

[0119] It should be noted that the described sensing mechanism is applicable to both single-segment anastomosis devices (e.g., disks, rings, or other fixation devices) and multi-segment anastomosis devices (e.g., devices having magnetically articulating segments that may be self-assembling).

[0120] FIG. 9A shows a non-limiting example of an external detector 13 in the form of a detector belt according to various exemplary embodiments. Various detectors as described above can be incorporated into the detector belt. The detector belt can take the form of a sash, sling, backpack, etc.

[0121] FIG. 9B shows an example of an external detector 13 in the form of a detector array according to various exemplary embodiments. Various detectors as described above can be integrated into the detector array. The detectors in the array may be arranged around the body to facilitate maximum sensitivity of detection. The detectors can be fixed to the body with tape, adhesive, straps, etc.

[0122] FIG. 10 is a diagram showing the steps of an anastomosis method between a patient's tissues according to various exemplary embodiments.

[0123] At 1010, a first magnetic compression anastomosis device is placed at a first target site adjacent to a first portion of the tissue. The first magnetic compression anastomosis device is placed using a delivery device that includes an elongate body having a lumen that completely penetrates it and is shaped and / or sized to receive and pass one or more magnetic compression anastomosis devices. The delivery device also includes a distal portion extending from the elongate hollow body. The distal portion includes a pair of arms extending from the elongate hollow body, each arm terminating at its respective distal end. Each respective distal end converges with the other to form a substantially integral tip configured to penetrate the tissue, and the pair of arms cooperate to form slots in fluid communication with the lumen of the elongate body.

[0124] At 1020, a second magnetic compression anastomosis device is disposed at a second target site adjacent to a second portion of tissue. The second magnetic compression anastomosis device is disposed using a delivery device that includes an elongate body having a lumen that completely penetrates it, and is shaped and / or sized to receive and pass one or more magnetic compression anastomosis devices. The delivery device also includes a distal portion extending from the elongate hollow body. The distal portion includes a pair of arms extending from the elongate hollow body, each arm terminating at its respective distal end. Each respective distal end converges with the other to form a substantially integral tip configured to penetrate tissue, and the pair of arms cooperate to form slots in fluid communication with the lumen of the elongate body.

[0125] Disposing the first and second magnetic compression anastomosis devices at the first and second target sites adjacent to the first and second portions of the patient's tissue may be based on a visual depiction of the positions of the first and second target sites provided by an imaging modality. The imaging modality can include at least one of a medical imaging procedure, wavelength detection, X-ray based imaging, illumination, computed tomography, X-ray imaging, and fluoroscopy, or a combination thereof. The medical imaging procedure includes ultrasound.

[0126] At 1030, the first and second magnetic compression anastomosis devices are brought into proximity with each other. Here, the first magnetic compression anastomosis device is brought into proximity with the second magnetic compression anastomosis device. A first distance between the first magnetic compression anastomosis device and the second magnetic compression anastomosis device can be determined when they are in proximity to each other. The first distance can be between 10 cm and 1 cm.

[0127] At 1040, the first and second magnetic compression anastomosis devices are fitted to each other, thus forming a magnetic stack that surrounds the first and second tissues. By combining the first magnetic compression anastomosis device and the second magnetic compression anastomosis device, the first part of the tissue and the second part of the tissue come together, and thus a magnetic stack is formed. The distance between the first magnetic compression anastomosis device and the second magnetic compression anastomosis device when they are fitted to each other is between 10 mm and 2 mm. The first magnetic compression anastomosis device and the second magnetic compression anastomosis device that are to be fitted are circumscribed to the first tissue and the second tissue. The magnetic stack includes the first magnetic compression anastomosis device at the base of the magnetic stack. The first part of the tissue is stacked on the first magnetic compression anastomosis device and is adjacent to the first magnetic compression anastomosis device. The second part of the tissue is stacked on the first part of the tissue and is adjacent to the first part of the tissue. The second magnetic compression anastomosis device is on the second part of the tissue and is adjacent to the second part, thus completing the magnetic stack. Therefore, the first and second tissues are compressed between the first and second magnetic compression anastomosis devices.

[0128] At 1050, the first and second parts of the tissue surrounded by the magnetic stack are necrotized and deteriorated. The first part of the tissue and the second part of the tissue are circumscribed by the first magnetic compression anastomosis device and the second magnetic compression anastomosis device in the magnetic stack to enable the first part and the second part of the tissue to necrotize and deteriorate. The distance between the first magnetic compression anastomosis device and the second magnetic compression anastomosis device when the first and second tissues are necrotized and deteriorated is between 2 mm and 0.5 mm.

[0129] At 1060, the magnetic stack can fall from the necrotized and deteriorated patient tissue and advance out of the patient.

[0130] At 1070, optionally, the magnetic stack is tracked. To track the magnetic stack, a tracking device is used. The tracking device includes one or more detectors that detect one or more magnetic compression anastomosis devices. The tracking device also includes one or more sensors disposed on one or more magnetic compression anastomosis devices. The one or more sensors generate an output signal that can be detected by the one or more detectors.

[0131] At 1080, optionally, it is determined whether the magnetic stack has advanced out of the patient. The determination of whether the magnetic stack has advanced out of the patient is made when the one or more detectors are unable to detect either the magnetic stack or one or more of the sensors.

[0132] Incorporation by reference References and citations to other documents such as patents, patent applications, patent publications, magazines, books, papers, web content, etc. are made throughout this disclosure. All such documents are hereby incorporated by reference in their entirety for all purposes.

[0133] Equivalent examples The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. Accordingly, the foregoing embodiments are not intended to limit the invention described herein, but should be regarded as illustrative in all respects. Therefore, the scope of the present invention is indicated by the appended claims rather than the foregoing description, and it is intended that all modifications within the meaning and scope of the equivalents of the claims be included.

Claims

1. A system for remotely tracking multiple magnetic compression anastomosis devices within a patient, The system includes a magnetic compression anastomosis device configured to be delivered within the patient to form an anastomosis within the patient, and a tracking device. The magnetic compression anastomosis device is At least one magnetic or magnetizable compression anastomosis element for forming an anastomosis through a body cavity, One or more sensors coupled to the at least one magnetic element, configured to detect the distance between the magnetic compression anastomosis device and a paired magnetic compression device over time and to generate a sensor signal indicating the distance, A wireless transmitter configured to wirelessly transmit an output signal indicating the distance based on the sensor signal, A power supply for supplying power to one or more sensors and the wireless transmitter, Includes, The aforementioned tracking device is One or more detectors wirelessly receive the output signal from the wireless transmitter of the magnetic compression anastomosis apparatus, A processor configured to track the progress of anastomosis formation based on a distance determined from the output signal, system.

2. The one or more detectors are located outside the patient. The system according to claim 1.

3. The one or more detectors include a mountable sash attached to the patient's body, and the mountable sash includes one or more individual detectors that detect signals. The system according to claim 2.

4. The one or more detectors include a detector array, and the detector array includes one or more individual detectors attached to the patient's body to detect signals. The system according to claim 2.

5. The one or more sensors include at least one of a force sensor, a pressure sensor, a magnetic field sensor, or a proximity sensor. The system according to claim 1.

6. The processor is configured to predict when the device will detach and / or leave the body based on the decrease in the distance over time, and optionally the distance between the magnetic compression anastomosis device and the paired magnetic compression device is initially about 10 mm to 2 mm, for example about 8 mm to 3 mm, and decreases to about 2 mm to 0.5 mm, for example about 1.5 mm to 0.75 mm. The system according to claim 1.

7. The magnetic compression anastomosis apparatus comprises a plurality of magnetic or magnetizable compression anastomosis elements configured to self-organize from a linear delivery arrangement to an annular unfolding arrangement. The system according to claim 1.

8. The system further comprises an exoskeleton supporting the plurality of magnetic or magnetizable compression anastomose elements, wherein the exoskeleton optionally includes at least one sensor. The system according to claim 7.

9. The processor is configured to determine the quality of pairing the magnetic compression anastomosis devices based on the distance identified from the output signal. The system according to claim 1.

10. A magnetic compression anastomosis device configured to be delivered into a patient in order to form an anastomosis within the patient, At least one magnetic or magnetizable compression anastomosis element for forming an anastomosis through a body cavity, One or more sensors coupled to the at least one magnetic element, configured to detect the distance between the magnetic compression anastomosis device and a paired magnetic compression device over time and to generate a sensor signal indicating the distance, A wireless transmitter configured to wirelessly transmit an output signal indicating the distance based on the sensor signal, A power supply for supplying power to one or more sensors and the wireless transmitter, Equipped with, Magnetic compression anastomosis device.

11. The one or more sensors include at least one of a force sensor, a pressure sensor, a magnetic field sensor, or a proximity sensor. The apparatus according to claim 10.

12. The magnetic compression anastomosis apparatus comprises a plurality of magnetic or magnetizable compression anastomosis elements configured to self-organize from a linear delivery arrangement to an annular unfolding arrangement. The apparatus according to claim 10.

13. Further comprising an exoskeleton supporting the plurality of magnetic or magnetizable compression anastomosis elements, wherein the exoskeleton optionally includes at least one sensor. The apparatus according to claim 12.

14. The system according to claim 1, wherein the power supply includes an internal power supply, and optionally the internal power supply comprises a battery or a fuel cell.

15. The system according to claim 1, wherein the power supply is supplied by the tracking device or other external device.

16. The apparatus according to claim 10, wherein the power supply includes an internal power supply, and optionally the internal power supply comprises a battery or a fuel cell.

17. The apparatus according to claim 10, wherein the power supply is supplied by an external device.

18. A method for remotely tracking a magnetic compression anastomosis device in a patient, wherein the method is: The step of wirelessly receiving an output signal from a wireless transmitter of a magnetic compression anastomosis apparatus, wherein the magnetic compression anastomosis apparatus is At least one magnetic or magnetizable compression anastomosis element for forming an anastomosis through a body cavity, One or more sensors coupled to the at least one magnetic element, configured to detect the distance between the magnetic compression anastomosis device and a paired magnetic compression device over time and to generate a sensor signal indicating the distance, A wireless transmitter configured to wirelessly transmit an output signal indicating the distance based on the sensor signal, A step comprising one or more sensors and a power supply for supplying power to the wireless transmitter, A step of tracking the progress of anastomosis formation based on the distance determined from the output signal received wirelessly, A method that includes this.

19. The method according to claim 18, wherein tracking the progress of anastomosis formation is A method comprising predicting when the device will detach and / or leave the body based on the decrease in the distance over time, wherein the distance between the magnetic compression anastomosis device and a paired magnetic compression device is initially about 10 mm to 2 mm, for example about 8 mm to 3 mm, and then decreases to about 2 mm to 0.5 mm, for example about 1.5 mm to 0.75 mm.

20. The method according to claim 18, further, A method comprising determining the quality of pairing the magnetic compression anastomosis devices based on the distance identified from the output signal received wirelessly.

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