Devices, systems, and methods for positioning endoscopes

Abstract

The present invention provides medical devices, systems, and methods that facilitate the positioning of a device within the body, such as by facilitating the identification of the location of a target site within the body. [Solution] A locator system 1000 that is deployable to a target site TS within a first anatomical structure and identifiable from within a second anatomical structure. The locator system includes a signal generator and a tissue engagement member 120. The tissue engagement member engages with the tissue of the target site, thereby allowing the delivery system to deliver and withdraw the locator system without disturbing its position while the tissue engagement member is engaged with the tissue of the target site. The locator system can be deployed to a target site in the patient's intestine, identified from within the patient's stomach, and create an anastomosis between the stomach and the target site.

Description

Technical Field

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[0003]

[0001] The present disclosure generally relates to the field of medical devices for use in the body. In particular, the present disclosure relates to medical devices, systems, and methods for use in endoscopic procedures. More specifically, the present disclosure relates to medical devices, systems, and methods that facilitate positioning of a device within the body, such as facilitating identification of the location of a target site within the body.

Background Art

[0002] Visualizing, positioning, and manipulating anatomical structures, devices, and / or anatomical structures containing one or more devices within the body can sometimes be difficult. During a procedure within the body, such as an endoscopic procedure (not an invasive incision of the body) within a body lumen, a medical professional may need to externally identify a particular anatomical structure within the body and its location within the body. Due to lack of illumination or low illumination levels, and / or intervening anatomical structures, and / or the shape and / or structure of various parts of the body, it can be difficult to identify the desired anatomical structure within the body and / or its location within the body. For example, during a procedure within a body lumen such as the intestine, there may appear long anatomical regions that are difficult to distinguish from outside the body. Various positioning devices may be provided within the body. However, when operating a device within the body with respect to such a positioning device (e.g., performing a procedure while operating the device and / or pulling out a delivery device of the positioning device), the purpose and function of such a positioning device may be hindered due to displacement of such a positioning device.

[0003] With regard to these and other considerations, the improvements of the present application may be useful.

Summary of the Invention

[0004] This summary of the disclosure is provided for the purpose of aiding understanding, and those skilled in the art will understand that each of the various aspects and features of the disclosure may, in some cases, be used separately to their advantage, or in other cases, in combination with other aspects and features of the disclosure. Whether or not this summary includes elements, components, etc., it is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of this disclosure, a locator system includes a flexible elongated member, a beacon attached to the flexible elongated member, and a tissue engagement member configured to fix the locator system to the target site by engaging with the tissue of the target site.

[0006] In some embodiments, the tissue engagement member is expandable to secure the locator system to the target site by engaging with the tissue of the target site. In some embodiments, the tissue engagement member is an inflatable balloon. In some embodiments, the tissue engagement member is an expandable stent. In some embodiments, the tissue engagement member is mounted on the flexible elongated member.

[0007] In some embodiments, the tissue engagement member comprises a pair of gripping arms configured to grip the tissue of a target site located between them. In some embodiments, the locator system further includes a controller extending along the flexible elongated member and actuated to shift the tissue engagement member between a delivery configuration and a tissue engagement configuration. In some embodiments, the tissue engagement member is inflatable, and the controller is an expansion lumen extending through the flexible elongated member. In some embodiments, the tissue engagement member is inflatable, and the controller is an expansion lumen in an expansion line extending along the flexible elongated member. In some embodiments, the controller is a sheath extending around the flexible elongated member, and the tissue engagement member is an expandable stent, which is located within the controller in the delivery configuration and expandable into a tissue engagement configuration when outside the controller. In some embodiments, the tissue engagement member has a pair of gripping arms configured to grip tissue of a target site between them.

[0008] According to various principles of this disclosure, a locator system includes a beacon, a tissue engagement member, and a controller that can be operated to shift the tissue engagement member between a delivery configuration in which the tissue engagement member is compact and deliverable transluminally to a target site, and a tissue engagement configuration in which the tissue engagement member engages with the tissue of the target site to fix the beacon to the target site.

[0009] In some embodiments, the locator system includes a flexible elongated member to which the beacon and the tissue engagement member are attached. In some embodiments, the tissue engagement member is an inflatable balloon, and the controller is an inflatable lumen communicating with the balloon.

[0010] In some embodiments, the controller is a sheath, and the tissue engagement member is an expandable stent that can shift between a delivery configuration when inside the sheath and an expanded tissue engagement configuration when outside the sheath.

[0011] In some embodiments, the tissue engagement member includes a pair of jaws which are movable by the controller between a closed configuration in which the jaws are in a delivery configuration or gripping tissue between the jaws, and an open configuration in which the jaws can engage with tissue between the jaws.

[0012] According to various principles of this disclosure, a method for locating a target site in a first anatomical structure from within a second anatomical structure includes: delivering a locator system to the target site using a delivery system; fixing the locator system to the target site by engaging the tissue-engaging members of the locator system with the tissue of the target site; withdrawing the delivery system from the locator system so that the locator system remains fixed in place relative to the target site; and locating and identifying the locator system from the second anatomical structure through at least the wall of the second anatomical structure.

[0013] In some embodiments, the method includes forming an anastomosis between a first anatomical structure and a second anatomical structure along a target site. In some embodiments, the method includes fixing the locator system to a target site by extending the tissue engagement member from a compact delivery configuration to an extended configuration, thereby engaging it with the tissue at the target site.

[0014] In some embodiments, the method includes fixing the locator system to a target site by gripping the tissue of the target site between the gripping arms of the tissue engagement member.

[0015] These features and advantages of the present disclosure, as well as other features and advantages, will be readily apparent from the following detailed description. The scope of the present invention is set forth in the appended claims. The following disclosure is presented in terms of aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of its embodiment or other embodiments. [Brief explanation of the drawing]

[0016] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be drawn to any particular scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, locations, order, and relative sizes reflected in the numbers within the drawings may vary. For example, devices may be enlarged to allow for the identification of details, but are intended to be reduced to fit within, for example, the working channel of a delivery catheter or endoscope. In the drawings, identical, nearly identical, or equivalent elements are generally represented by the same reference numeral, similar elements are generally designated by similar reference numerals differing by 100, and redundant descriptions are omitted. For clarity and brevity, not all elements are referenced in all figures, nor are all elements of each embodiment shown where illustration is not necessary for a person skilled in the art to understand this disclosure.

[0017] A more detailed explanation can be better understood by referring to the attached diagram. In the diagram, similar reference letters represent the same elements as follows: [Figure 1] The following are perspective views of embodiments of an implantable locator system formed according to various aspects of this disclosure and positioned in a schematic diagram of the gastrointestinal environment. [Figure 2] This figure is similar to Figure 1, but the large intestine is shown by dashed lines, illustrating an example of an embodiment of a locator system deployed at the target site and a delivery system that delivers instruments to reach the target site. [Figure 3] This diagram is similar to Figure 2, showing the device shown in Figure 2 being delivered and reaching the target site. [Figure 4] This diagram shows the portion of the stomach and jejunum that are drawn together, as shown in Figure 3, along with the anastomosis between them. [Figure 5] This diagram is similar to Figure 4, but shows the tissue aproximeter holding the tissue walls of the stomach and jejunum side by side. [Figure 6]A perspective view of an example of an embodiment of a locator system formed according to various principles of this disclosure is shown. [Figure 7] An example of an embodiment of a locator system formed according to various principles of this disclosure is shown in a perspective view illustrating its delivery to a target site. [Figure 8] Figure 7 shows a perspective view of an example of a locator system in its deployed position. [Figure 9] An example of an embodiment of a locator system formed according to various principles of this disclosure is shown in a perspective view illustrating its delivery to a target site. [Figure 10] Figure 9 shows a perspective view of an example of an embodiment of a locator system in its deployed position. [Modes for carrying out the invention]

[0018] Detailed explanation The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and may vary. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided for illustrative purposes and is merely an example, not the only way to implement these principles. Accordingly, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of this disclosure and should not be understood as limiting this disclosure to specific elements, structures, or features illustrated. Other examples of ways of implementing the disclosed principles will be apparent to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and changes can be made in this disclosure without departing from the scope or spirit of the subject matter of the invention. For example, yet another embodiment can be obtained by using a feature illustrated or described as part of one embodiment in combination with another embodiment. Therefore, the subject matter of the invention is intended to encompass such modifications and changes that fall within the scope of the appended claims and their equivalents.

[0019] It will be understood that the present disclosure is described herein at various levels of detail. In some cases, details that are not necessary for those skilled in the art to understand the present disclosure, or details that make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein are to be understood as commonly understood by those skilled in the art to which the present disclosure pertains. All devices and / or methods disclosed and claimed herein can be made and implemented without undue experimentation in light of the present disclosure.

[0020] As used herein, "proximal" refers to the direction or position that is closest to a user (such as a medical professional, clinician, technician, operator, physician, etc., which terms are used interchangeably herein without intention of limitation and including an automated control system, etc.) and / or closest to a delivery device during use of the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Distal" refers to the direction or position that is farthest from the user and / or closest to the delivery device during use of the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means a central point that at least approximately bisects and / or is approximately equidistant from the perimeter or boundary, and "central axis" means, with respect to an opening, a line that extends longitudinally along the length of the opening and at least approximately bisects the central point of the opening when the opening includes, for example, a tubular element, strut, channel, cavity, or hole.

[0021] Many medical procedures require locating the position of anatomical structures such as organs or tissue walls, and then delivering a medical instrument to that location to perform the procedure at the identified location (e.g., “target site,” “target tissue,” or “target tissue site”). This disclosure is applicable to any such location, and references to any such designation are applicable to other designations without limitation unless otherwise specified. In some cases, such as when a procedure is performed after the identification of an anatomical location, it may be desirable to be able to identify the identified location later (e.g., after the delivery system of the locator system has been removed) and / or from another location within the body. Non-limiting examples of possible procedures include various medical procedures that involve moving a tissue wall (e.g., a body cavity wall or organ wall) to a desired location, for example, relative to another tissue wall (e.g., a body cavity wall or organ wall). For example, various procedures can be performed by inserting an anchor or stent into the gastrointestinal tract (GI duct) through a first organ or structure (such as the esophagus, stomach, duodenum, small intestine, large intestine, or abdominal cavity) and delivering it to an adjacent organ, lumen, or tissue structure (such as an adjacent portion of the GI duct, bile duct, pancreatic duct, gallbladder, pancreas, cyst, pseudocyst, or abscess). Typically, it is necessary to penetrate both an access tissue wall (e.g., the organ wall or the first body lumen) to establish access and a second tissue wall (e.g., the organ wall or the second body lumen) along, adjacent to, or at the target of the procedure. Stents or other tissue anchors may be deployed between adjacent body lumen, organs, or other structures, for example, to maintain the juxtaposition of tissue walls and / or to create an anastomosis, according to the instructions of the procedure. In addition to stents, tissue anchors can be used to fix adjacent tissue or organs before the stent is deployed and may remain in place after the stent has been deployed.

[0022] Endoscopic procedures have been used to create connections, such as anastomoses, between the stomach and specific parts of the intestines through gastrointestinal anastomosis. For example, bypassing a portion of the duodenum by forming an anastomosis between the stomach and the small intestine (including the distal duodenum or jejunum), for example, extending more than 150 cm from the pylorus, can improve the symptoms of the disease. In cases of gastric outlet obstruction, gastrojejunostomy is performed to drain the contents of the stomach into the jejunum below / distal to the obstructed / dysfunctional duodenum. By forming an anastomosis between the stomach and jejunum and bypassing the duodenum, gastrojejunostomy can be a minimally invasive and potentially reversible treatment option for patients with metabolic diseases, resulting in desirable metabolic effects. This method avoids the absorption of stomach contents (e.g., food and other nutrients) in the duodenum, and as such contents move from the stomach through the small intestine, nutrients from such contents may not be absorbed, or their intake or absorption may be delayed, potentially promoting weight loss in patients and potentially controlling or resolving type 2 diabetes.

[0023] Gastrointestinal anastomoses and other internal procedures can be performed surgically, either endoscopically (gastroscopy or laparoscopy) or through open surgery. Endoscopic procedures such as gastrointestinal anastomoses present various challenges, including the need to endoscopically locate a desired location (which may be referred to herein as the “target site” or “target tissue site”), such as within the intestines, through the gastric cavity. Ultrasound and / or fluoroscopy provide images that penetrate anatomical walls (e.g., the stomach wall and intestinal wall). However, while ultrasound is useful for imaging tissue, inorganic materials used for tissue identification may not be readily imaged by ultrasound. Fluoroscopy is suitable for observing high-density materials, such as those used in medical instruments, but contrast agents used in fluoroscopy may dissipate while locating the target tissue, thus requiring reinjection. It will be understood herein that terms such as instruments, tools, and devices may be used interchangeably without intent to limit them.

[0024] Another solution involves multiple devices that operate as follows: First, a beacon system with a light at the distal end of a flexible, elongated member (such as a guidewire or tubular element) is inserted using an endoscope or similar device to the desired location of the procedure (e.g., where a connection between the intestine and stomach is to be created). The endoscope is withdrawn, leaving the light in place. Next, the endoscope is reinserted into the body (e.g., parallel to the flexible, elongated member with the light at the distal end), and one or more instruments are inserted to perform the procedure, such as incising the stomach wall or peritoneum. By visualizing the light or locating it by other means, the target site of the procedure can be identified, allowing the procedure to be performed at the desired target site. For example, once inside the peritoneum, the physician uses the light inside the small intestine, visible from the outside of the intestinal wall, to locate the desired portion of the small intestine. The outside of the small intestine is grasped and joined with the stomach. Then, a stent is deployed to connect the small intestine and stomach, forming an anastomosis.

[0025] The above solution, which uses a light to locate the target site for the procedure, also has several challenges. For example, in the initial stages of the procedure, after positioning the guidewire in the desired location, the endoscope must be withdrawn from the body while maintaining the position of the light within the body. To maintain the light in its original desired position, the withdrawal of the endoscope must be coordinated with the advancement of the flexible elongated member in which the light is positioned. Such procedures can be difficult to perform accurately and tend to affect the final position of the light, and consequently, the position in which one or more instruments for the procedure will be advanced (e.g., the portion of the small intestine where the anastomosis with the stomach is formed), which is a critical factor for the success of the procedure.

[0026] This disclosure relates to devices, systems, and methods useful for performing procedures such as endoscopy, laparoscopy, and / or open surgery in the body, by first identifying the target site of the procedure with a locator system, deploying the locator system to the target site, then locating the position of the locator system, and performing the procedure at the desired target site identified by the locator system. In some embodiments, the devices, systems, and methods may be used to create anastomoses such as gastrojejunostomies. For example, the devices and systems described herein can assist in the placement of a gastrojejunostomy by reliably and repeatedly identifying a desired location within the patient's gastrointestinal system, for example, by identifying a location within the jejunum such as the proximal, distal, or adjacent portion of the ligament of Treitz. Furthermore, the devices and systems described herein enable medical professionals to locate, grasp, hold, and / or cut portions of the stomach and small intestine during gastrojejunostomy surgery. Optionally, a stent or other conduit may also be placed in the bypass bridging the walls of the stomach and jejunum through which the opening has been created. A stent or conduit may help establish the anastomosis or keep it open until the anastomosis stabilizes. The stent may or may not be removed afterward.

[0027] It will be understood that various principles of this disclosure can be applied to devices, systems, and methods for performing other procedures within a patient's body using the locator systems and locator system delivery and deployment systems disclosed herein. Therefore, although the systems, devices, and methods described herein are described in relation to the gastrointestinal system, it will be understood that the devices, systems, and methods herein may be advantageous for use in any other procedure involving the grasping, manipulation, or cutting of tissue (e.g., body lumens and / or other sensitive tissue structures). Furthermore, it should be understood that the systems, devices, and methods described herein can also be used in other areas of anatomical structure where the selective location of tissue passes through and / or is not visible from other tissue walls.

[0028] According to various principles of this disclosure, a locator system is delivered to a target site by a delivery system and fixed to the target tissue of the target site (for example, so that its location can be identified from another area of ​​the body). By engaging the locator system with the tissue in this manner, the locator system is fixed to the target site, eliminating the need for coordination between removing the delivery system and maintaining the locator device in the desired position at the target site. It will be understood that terms such as joining, engaging, grasping, holding, fastening, pinching, fixing, attaching, maintaining, and mooring (and other grammatical forms thereof) may be used interchangeably as described herein without intent to limit. Furthermore, it will be understood that terms such as locator, beacon, guide, signal, emitter, light, etc., may be referred to interchangeably as described herein without intent to limit.

[0029] In some embodiments, the locator system includes a tissue engagement member configured to fix the locator system to the tissue at the target site. The tissue engagement member may, but will not be limited to, a tissue fastener or clip, or other mechanical fixation device (e.g., hemostatic clip, clamp, grabber, basket, gripper, magnet, adhesive, etc.) as herein. The tissue engagement member may be shiftable between a delivery configuration (e.g., a compact configuration that facilitates delivery of the locator system to the target site) and a tissue engagement configuration (e.g., engaging with tissue to fix the locator system to the engaging tissue). An actuator may be provided to shift the tissue engagement member between the delivery configuration and the tissue engagement configuration. Furthermore, it will be understood that the tissue engaged by the tissue engagement member at the target site may be at the location where a procedure such as an anastomosis is performed, or distal or proximal to such a procedure, depending on the procedure performed, the technology used, and the designation of the medical professional.

[0030] Various embodiments of devices, systems, and methods for locating within the body are described below with reference to examples shown in the accompanying drawings. References in this specification such as “one embodiment,” “one embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or characteristics in accordance with the principles of this disclosure may be included in relation to that embodiment. However, such references do not necessarily mean that all embodiments include that particular feature, structure, concept, and / or characteristic, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations. It should be understood that one or more features, structures, concepts, and / or characteristics described with reference to one embodiment can be combined with one or more features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. In other words, hybrid embodiments can be created by combining any of the features, structures, concepts, and / or characteristics described herein, and such hybrid embodiments are within the scope of this disclosure. Furthermore, references to “one embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive with other embodiments. Moreover, it should be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent of each other and may be used or presented individually or in various combinations with each other to create alternative embodiments, and these may also be considered part of this disclosure. Therefore, because it would be too cumbersome to describe all of the numerous possible combinations and subcombinations of features, structures, concepts, and / or characteristics, this disclosure is not limited to the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure. The following description is merely an illustrative example of embodiments and is not intended to limit broader aspects of this disclosure.

[0031] In the drawings, common features are identified by common reference elements, and for the sake of brevity and convenience, and without any intention of limitation, descriptions of common features are usually not repeated. For clarity, not all components having the same reference number are numbered. Furthermore, groups of similar elements may be indicated by numbers and letters, and a single element or such elements, or such elements as a group, may be referred to by numbers only (without including the letters associated with each similar element). In the following description, elements or components that are similar between various illustrated embodiments with reference numbers less than 1000 are usually designated by adding a multiple of 1000 to the same reference number, and redundant descriptions are usually omitted for brevity. Furthermore, certain features of one embodiment may be used across different embodiments and are not necessarily individually labeled when appearing in different embodiments.

[0032] Referring next to the drawings, an example of an embodiment of the locator system 100 and a delivery system 1000 configured to deliver the locator system 100 to a target site TS is shown in the schematic diagram of the gastrointestinal system in Figure 1. It will be understood that the principles of this disclosure can be applied to other anatomical sites and structures, but for convenience and without intent to limit, we will refer to the location and structure of the gastrointestinal system. Furthermore, it will be understood that the tissue to be engaged by the tissue engagement member at the target site may be at the location where a procedure such as an anastomosis is performed, or distal or proximal to such a procedure, depending on the procedure performed, the technique used, and the designation of the medical professional. Furthermore, it will be understood that the expression "to" is intended to include the vicinity of (e.g., along, adjacent to, etc.) unless otherwise specified. In the illustrated example environment, the locator delivery system 1000 is inserted into the stomach S via a natural opening transluminal endoscopic surgery (NOTES) procedure (e.g., from the nose or mouth to the esophagus), passes through the pylorus P, and is inserted into the duodenum D. In an example of the embodiment shown in Figure 1, the locator delivery system 1000 includes a flexible elongated delivery member 1110 that can be delivered to a target site TS through the body. The flexible elongated delivery member 1110 may be delivered through a lumen in a flexible elongated tubular member (e.g., a shaft, catheter, or endoscope) known to those skilled in the art for transluminal delivery of devices through the body (as opposed to by open surgery techniques). In some embodiments, the flexible elongated delivery member 1110 is delivered via an endoscope (not shown, but any of the various endoscopes known to those skilled in the art) equipped with visualization and / or imaging capabilities for easy location of the target site TS.

[0033] The locator system 100 is advanced by the locator delivery system 1000 to the desired target site TS of the locator system 100. The locator delivery system 1000 and the locator system 100 can be advanced using a control handle located at the proximal end of the locator delivery system 1000 (not shown, but this may be any suitable control handle known to those skilled in the art, the details of which are not limiting or important to this disclosure). Peristaltic movement through the GI system may also aid in the advancement of the locator delivery system 1000 and the locator system 100. In the example environment shown in Figure 1, the target site TS is located in the jejunum J, for example, adjacent to, proximal to, or distal to the ligament of Treitz LT. A portion of the jejunum J may be selected as the “target site TS” at a distance from the pylorus P where the anastomosis between the jejunum J and the stomach S is formed (for example, determined by a medical professional). The locator delivery system 1000 can assist in the identification and selection of a target site TS by means of optical / visualization elements known to those skilled in the art (e.g., cameras, scopes, optical fibers, fluoroscopy, etc., details of which are not limiting or important to this disclosure). The locator system 100 is advanced to the target site TS by the locator delivery system 1000. A beacon 110 on the locator system 100 is used to identify the target site TS, thereby allowing the location of the target site TS to be determined by an instrument at another anatomical location, such as within the stomach S, as will be described in more detail below. The beacon 110 is one of a variety of devices that emit signals that can be located through anatomical tissue. In some embodiments, the beacon 110 includes one or more light-emitting diodes (LEDs).

[0034] According to various principles of this disclosure, when the locator system 100 reaches the target site TS, the locator system 100 is deployed by engaging the tissue engagement member 120 (described in more detail below) of the locator system 100 with the tissue of the target site TS. In this way, the locator system 100 is fixed to the target site TS and the locator delivery system 1000 can be withdrawn from the locator system 1000 without affecting the position of the locator system 100. Next, an instrument for forming an anastomosis between the target site TS and a portion of the stomach S (preferably near the target site TS in the jejunum J) is inserted into the body to form an anastomosis between the target site TS and the stomach S.

[0035] To form an anastomosis between the jejunum J and the stomach S, a delivery system 2000, as shown in Figure 2, can be inserted into the GI system via a NOTES procedure or the like, and then further inserted into the stomach S. It will be understood that the delivery system 2000 used to form the anastomosis may include common delivery components similar to those in the locator delivery system 1000. For example, an endoscope can be used in the delivery system 2000 as in the locator delivery system 1000. The delivery system 2000 includes a visualization system that can visualize the beacon 110 of the locator system 100 to pinpoint the location of the target site TS. For example, the delivery system 2000 may include an endoscope with a camera, or other visualization systems known or previously known to those skilled in the art, but the details thereof are not important and do not limit the principles of this disclosure. Once the location of the target site TS is pinpointed, the delivery system 2000 delivers various instruments, tools, devices, etc. (these terms are used interchangeably herein without intent to limit them) to form an anastomosis between the target site TS and an appropriate location along the stomach S.

[0036] For example, as shown in Figure 2, the delivery system 2000 delivers the cutting tool 2010 to create an opening (guided by the beacon 110) that penetrates the wall of the stomach S within the region of the target site TS. In this specification, the term “cutting” should be understood in a broad sense as creating an opening, and “cutting tool” should be understood as any tool known to those skilled in the art that can create an opening in tissue, such as a blade, ablation tool (e.g., with ablation blade), needle, scissors, ablation device, or other energy delivery device, and it will be understood that this disclosure does not particularly limit cutting to the narrow sense of the term. A grasping tool 2020 (any grabper known to those skilled in the art that can grasp tissue, such as an end effector, clip, snare, etc.) is delivered by the delivery system 2000 (for example, through the working channel into which the cutting tool 2010 was delivered, and after the cutting tool 2010 has been withdrawn, or through another working channel of the delivery system 2000, or as part of the cutting tool 2010, or otherwise) and is extended through the hole in the stomach S cut by the cutting tool 2010, as shown in Figure 3. The grasping tool 2020 is extended toward the jejunum J, grasps the portion of the jejunum J containing the target site TS (identified by the locator system 100), and pulls that portion of the jejunum J toward the stomach S. The jejunum J is held in place relative to the stomach S, and an anastomosis can be formed between them in any desired manner known or previously known to those skilled in the art.

[0037] For example, in some embodiments, the anastomosis system 2030 can be delivered to the adjacent portions of the jejunum J and stomach S to form an anastomosis between them. As shown in Figure 4, in some embodiments, the anastomosis system 2030 can hold the adjacent portions of the jejunum J and stomach S together (e.g., using a retaining member 2034 in the jejunum J and a retaining member 2036 in the stomach S) and deliver a stent 2032 configured to form an anastomosis between them (e.g., through a lumen 2035 via the stent 2032). In some embodiments, such as shown in Figure 5, the jejunum J and stomach S are held in close contact by a tissue aproximeter 2040, and the stent 2032 is deployed through such tissue walls to form an anastomosis (as described above with respect to an example of the embodiment shown in Figure 4). In some embodiments, the tissue aproximeter 2040 extends through adjacent tissue walls and is configured to hold the tissue walls side by side by an expanded tissue fixation end 2044 in the jejunum J and an expanded tissue fixation end 2046 in the stomach S, etc. By deploying the stent 2032 adjacent to the tissue apoxymeter 2040 (as described above with respect to the example embodiment shown in Figure 4), an anastomosis can be formed as in the example embodiment shown in Figure 5. The example embodiment of the tissue apoxymeter 2040 shown in Figure 4 can be delivered by a delivery system 2000 and / or anastomosis system 2030 (which may share some features and / or structures). In some embodiments, the tissue apoxymeter 2040 is deployed through an opening formed by a cutting tool 2010. In such cases, the anastomosis system 2030 may include a cutting tool for creating an opening in the adjacent walls of the jejunum J and stomach S adjacent to the tissue apoxymeter 2040, and a deployment device for deploying the stent 2032 through there. Once the anastomosis between the jejunum J and stomach S is formed, the locator system 100 may be removed and therefore may optionally be absent, as shown in Figures 4 and 5.

[0038] Examples of embodiments of locator systems 200, 300 formed in accordance with various principles of this disclosure and used as described above are shown in further detail in Figures 6, 7, 8, 9, and 10.

[0039] In the example of the locator system 200 embodiment shown in Figure 6, the beacon 210 is adjacent to the distal end 201 of the locator system 200, distal to the tissue engagement member 220. The beacon 210 and the tissue engagement member 220 are illustrated to be attached to a flexible elongated member 230, for example, along its distal end 231. The tissue engagement member 220 is proximal to the beacon 210 (attached adjacent to the distal end 231 of the flexible elongated member 230), but the reverse configuration is also included in the scope and spirit of this disclosure. The flexible elongated member 230 may be a guidewire, or other element that can move transluminally through the body (e.g., a GI system) to a target site TS, for example, an element known to those skilled in the art for delivering the beacon 210 to the target site TS (e.g., via a working channel or lumen in a delivery system 1000). The tissue engagement member 220 is in the form of an expandable element. For example, in the embodiment shown in Figure 6, the tissue engagement member 220 is an expandable balloon. However, other forms of expandable members that can expand to contact a tissue wall adjacent to the target site TS (for example, expand to contact the interior of a portion of the jejunum J adjacent to the target site TS) are also included in the scope and spirit of this disclosure for securing the locator system 200 to the target site TS. When the tissue engagement member 220 expands and contacts the tissue wall of the target site TS (for example, the interior of the jejunum J), the delivery system 1000 can be withdrawn from the target site TS without disturbing the position in which the tissue engagement member 220 secures the beacon 210, thereby allowing the location of the beacon 210 to be identified for further treatment.

[0040] As shown in Figure 6, the tissue engagement member 220 in the form of an expandable balloon may be formed from shape-conforming or shape-conforming biocompatible materials such as, but are not limited to, polyethylene terephthalate (PET), polyamides (nylon, polyamide homopolymers, polyamide copolymers, poly(ether-co-amide) copolymers, silicones, polyurethanes, polyarylene sulfides, polyurethane block copolymers, block copolymer thermoplastic elastomers, polyether-block-amide copolymers, polyester-block-ether copolymers, and combinations and / or copolymers thereof. The tissue engagement member 220 may be shifted between a delivery configuration with a compact configuration to facilitate transluminal delivery and an expanded tissue engagement configuration. The locator system 200 includes an expansion lumen to control the shift of the tissue engagement member 220 between the delivery configuration and the tissue engagement configuration. In some embodiments, the flexible elongated member 230 has an expansion lumen extending through it, and by supplying an expansion medium (e.g., a fluid such as air or saline solution) through this expansion lumen, the tissue engagement member 220 in the form of an inflatable balloon can be inflated. Alternatively, another expansion line 240 may be provided alongside the flexible elongated member 220, through which the expansion lumen passes and is defined. An air pump 250 for supplying the expansion medium to the tissue engagement member 220 and a deflation valve 260 for releasing the expansion medium and deflating the tissue engagement member 220 (for example, to remove the tissue engagement member 220 from the target site TS upon completion of a procedure formed with respect to the target site TS) may be coupled to the tissue engagement member 220 via the expansion line 240 or via the expansion lumen in the flexible elongated member 230, as schematically shown in Figure 6, so as to allow fluid flow.

[0041] Instead of an expandable member that can be expanded, such as in the example embodiment shown in Figure 6, a locator system 300 formed according to various principles of the present disclosure may have an expandable member in the form of a stent, as shown in Figures 7 and 8. Similar to the example embodiment shown in Figure 6, illustrated examples of embodiments of the locator system 300 shown in Figures 7 and 8 have a beacon 310 and an expandable tissue engagement member 320 mounted on a flexible elongated member 330. The beacon 310 is distal to the tissue engagement member 320, although the reverse configuration is also within the scope and spirit of the present disclosure. Furthermore, to protect, for example, the tissue engagement member 320 and / or to maintain a compact delivery configuration when the expandable tissue engagement member 320 is delivered to the target site TS through the delivery system 1000, the locator system 300 includes a sheath 340 extending at least over the tissue engagement member 320 in the delivery configuration, as shown in Figure 7. In some embodiments, the beacon 310 may be delivered distal to the sheath 340. As shown in Figure 8, when the beacon 310 is delivered to the target site TS, the sheath 340 is retracted proximally, allowing the expandable tissue engagement member 320 to expand and make contact with the tissue wall of the target site TS (e.g., inside the jejunum J). In this way, the delivery system 1000 can be withdrawn from the target site TS without disturbing the position in which the tissue engagement member 320 fixes the beacon 310, according to various principles of this disclosure, and its position can be identified for further treatment. The sheath 340 can be advanced distally over the tissue engagement member 320 to return the tissue engagement member 320 to a compact configuration and left in place so that it can be withdrawn and removed from the target site TS when treatment performed on the target site TS is complete.

[0042] The tissue engagement member 320 may be a self-expanding device such as a stent, which is known or previously known to those skilled in the art. For example, the support member may be formed of a shape-memory or thermoformable material (e.g., Nitinol or Elgiloy®) so that when the sheath 340 is withdrawn, the tissue engagement member 320 returns from a contracted configuration that maintains the tissue engagement member 320 in a compact delivery configuration to a pre-formed expanded configuration. More specifically, the expandable tissue engagement member 320 may be formed in various ways, such as from one or more support members combined to form a rigid and / or semi-rigid stent structure. The support members may be formed by braiding, winding, entangling, weaving, weaving, knitting, looping (e.g., bobbinette style), knotting, etc., one or more wires or filaments to form an expandable and contractible scaffold structure.The wire or filament may be made from a variety of non-limiting, preferably biocompatible materials, such as, but not limited to, polypropylene, polyester, polysulfone, nylon, polyurethane, polystyrene, polyethylene (PE) (including high-density PE and low-density PE), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate, polyether ether ketone (PEEK), poly(methyl methacrylate) (PMMA), polyethylene terephthalate (PET), polytetrafluoroethylene Polyethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polyether block esters, polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyether esters, ether-based or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, polyamides, ethylene vinyl acetate copolymer (EVA), silicones, polyethylene naphthalate (PEN), polyimide (PI) ), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, epoxy, poly(styrene-b-isobutylene-b-styrene), polycarbonates, ionomers, etc., mixtures, combinations, and copolymers thereof; metals, such as stainless steel, nickel-titanium alloys such as Nitinol, or cobalt-chromium-nickel alloys such as Elgiloy™. The support members may be formed from alloys of cellulose, etc.; bioabsorbable or biodegradable materials, such as polyglycolic acid, lactic acid, poly(lactic acid-co-glycolic acid), caprolactone, polymers, polydioxanone, cat or cow intestines, etc.; natural fibers, such as silk or cotton, etc.; or any mixture, composite material, combination, copolymer, or costructure of the above. Alternatively, the support members may be formed by cutting (e.g., laser cutting) a tubular structure (e.g., optionally a monolithic cylindrical tubular member) into an expandable configuration, and the support members are formed by such cutting.Such tubular members can be formed from any suitable material among those listed above, as will be understood by those skilled in the art.

[0043] Instead of expandable members, tissue engagement members of a locator system formed according to various principles of this disclosure can engage with tissue by grasping the tissue at a target site. For example, in the embodiment of the locator system 400 shown in Figures 9 and 10, the beacon 410 is delivered proximal to the tissue engagement member 420, and the gripping arm 422 of the tissue engagement member 420 extends distally to the distal end 401 of the locator system 400 to engage with the tissue at the target site TS. As shown in Figures 9 and 10, the beacon 410 is attached to a flexible elongated member 430 (e.g., a braided hollow shaft), which can also deliver the beacon 410 to the target site TS (e.g., via a working channel or lumen in the delivery system 1000). The controller 440 can actuarially engage with the gripping arm 422 to shift the gripping arm 422 between a closed configuration for delivery (shown in Figure 9) and an open configuration (shown in Figure 10) in which the gripping arm 422 engages with the tissue of the target site TS located between them along its distal end 421. In some embodiments, the gripping arm has one or more additional gripping features, such as a serrated or crenulated outer shape 429, or teeth along the distal end 421 and / or along its edge. When the tissue of the target site TS is located between the gripping arms 422, the controller 440 actsuarially to shift the gripping arm 422 to the closed configuration, in which the gripping arms 422 together grip the tissue between them. The delivery system 1000 can then be withdrawn from the target site TS without disturbing the position in which the tissue engaging member 420 is fixed to the beacon 410, and its position can be identified for further treatment. The controller 440 may be activated to return the gripping arm 422 to the delivery configuration in order to withdraw the tissue engagement member 420 from the target site TS, for example, when the procedure performed on the target site TS is completed.

[0044] In the embodiment of the tissue engagement member 420 shown in Figures 9 and 10, the gripping arm 422 is rotatably coupled on a pivot 425a. In some embodiments, the proximal end 423 of the gripping arm 422 is rotatably coupled to the distal end 427 of the actuator arm 424 around a pivot 425b. The proximal ends 429 of the actuator arms 424 may be coupled together around a further pivot 425c within the distal end 431 of the flexible elongated member 430, or they may be coupled to each other along a unified curve. To hold the tissue engagement member 420 in the closed configuration shown in Figure 9, a spring 442 may be positioned between the pivot 425a (to which the gripping arm 422 is coupled) and the proximal end 403 of the tissue engagement member 420. When the actuator 440 is retracted proximal, the pivot 425a (to which the gripping arm 422 is coupled) approaches the proximal end 403 of the tissue engagement member 420, causing the actuator arm 424 to rotate and the gripping arm 422 to shift to the open configuration shown in Figure 10. In such embodiments, the spring 442 may be configured to bias the tissue engagement member 420 to a closed configuration so that the tissue engagement member 420 returns to a closed configuration when the proximal force applied to the actuator 440 is released. Alternatively or in addition to this, the proximal ends 429 of the actuator arms 424 may be coupled together along a unified curve that forms a spring that biases the actuator arms 424 away from each other when extended distally from within the distal end 431 of the sheath 430. As shown in Figure 9, the distal end 431 of the sheath 430 holds the actuator arm 424 in a closed configuration, and the closed configuration of the actuator arm 424 holds the gripping arm 422 in a closed configuration. When the actuator 440 is advanced distally, the proximal end 429 of the actuator arm 424 moves forward from the distal end 431 of the sheath 430, allowing the gripping arm 422 to move into the open configuration shown in Figure 10. In such an embodiment, the spring 442 may or may not be present, and the gripping arm 422 is pulled back into the sheath 430 and closed.Other configurations of the gripping arm 422 and controller 440 are also within the scope and spirit of this disclosure, and it will be understood that this disclosure is not limited to the configurations of the embodiments shown in Figures 9 and 10.

[0045] In consideration of the foregoing, according to the various principles of this disclosure, as described above, the locator system is delivered and deployed to the target site in such a manner that the delivery system can be withdrawn without interfering with the locator system, i.e., without affecting the position in which the locator system is deployed at the target site. Subsequently, with the help of a visualization device that can identify the target site by locating the position of the locator system's beacon, a procedure can be performed on the target site using a tool located at another anatomical location within the body.

[0046] While embodiments of this disclosure may be described with particular reference to medical devices and systems used in GI systems (e.g., endoscopic devices, accessory tools, and / or guidewires), it should be understood that the locator devices and systems described herein can be used with a variety of medical procedures performed on anatomical structures of tubes, lumens, blood vessels, or body lumens, including, for example, interventional radiology (IVR) procedures, balloon angioplasty / angiography, thrombolytic procedures, urological or gynecological procedures. Medical devices as used herein include a variety of medical devices for advancing within body lumens, such as catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, and hysteroscopes. Furthermore, the disclosed medical devices and systems may be inserted via a variety of access points and approaches, such as percutaneous, endoscopic, laparoscopic, or a combination thereof.

[0047] It will be understood that the foregoing description is broadly applicable and presented for illustrative and explanatory purposes, and is not intended to limit this disclosure to the forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concepts, spirit, and scope of this disclosure. In particular, it will be apparent to those skilled in the art that the principles of this disclosure can be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concepts, spirit, scope, or characteristics thereof. For example, various features of this disclosure can be grouped into one or more aspects, embodiments, or configurations for the purpose of streamlining this disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of this disclosure can be combined in alternative aspects, embodiments, or configurations. Although this disclosure is presented in terms of embodiments, it should be understood that not all of such individual features are necessary to achieve at least some of the desired characteristics and / or advantages of the subject matter of the invention or its various individual features. Those skilled in the art will understand that this disclosure may be used with many changes or modifications to the structure, arrangement, proportions, materials, components, and other aspects that are particularly suited to specific environmental and operating requirements, without departing from the principles, spirit, or scope of this disclosure used in its implementation. For example, elements shown to be formed as a single unit may consist of multiple parts, elements shown as multiple parts may be formed as a single unit, the operation of elements may be changed in reverse order or in other ways, and the size or dimensions of elements may be changed. Similarly, where operations, actions, or procedures are described in a particular order, it should not be understood that such a particular order is necessary, or that all operations, actions, or procedures must be performed, in order to obtain the desired result. Furthermore, other implementations are also within the scope of the following claims. In some cases, the operations described in the claims may be performed in a different order to obtain the desired result.Accordingly, the embodiments disclosed herein should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to any particular embodiment or configuration described or illustrated herein or in the foregoing description. In light of the foregoing, any individual feature of any embodiment may be used and claimed separately or in combination with features of that embodiment or other embodiments, and the scope of the subject matter of the invention is indicated by the appended claims and is not limited to the foregoing description.

[0048] From the foregoing description and the following claims, it will be understood that: The phrases “at least one,” “one or more,” and “and / or” as used in this application are open-ended expressions that function as both conjunctions and separators. Terms such as “one,” “it,” “the aforementioned,” “first,” and “second” do not preclude the plural form. For example, the term “one” as used in this application refers to one or more of its entities. Thus, the terms “one,” “one or more,” and “at least one” are interchangeable in this application. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or similar) are used solely for identification purposes to aid the reader’s understanding of this disclosure and / or serve to distinguish areas of related elements from one another, and do not limit the related elements in particular with respect to the location, orientation, or use of this disclosure. References of connection (e.g., attached, joined, connected, engaged, joined) should be interpreted broadly and, unless otherwise specified, may include intermediate members between sets of elements or relative movement between elements. Therefore, a reference of connection does not necessarily mean that two elements are directly connected and have a fixed relationship with one another. References of identification (e.g., primary, secondary, first, second, third, fourth, etc.) do not imply importance or priority, but are used to distinguish one feature from another.

[0049] The following claims are incorporated by this reference into this detailed description, and each claim exists independently as a separate embodiment of the present disclosure. In the claims, the term “includes” does not preclude the presence of other elements, components, features, areas, integers, steps, operations, etc. Furthermore, individual features may be included in different claims, but they may be advantageously combined, and inclusion in different claims does not mean that the combination of features is not viable and / or advantageous. Furthermore, singular references do not preclude plural references. Reference numerals in the claims are provided merely as illustrative examples and are not to be construed as limiting the scope of the claims.

Claims

[Claim 1] Flexible long member, A beacon attached to the aforementioned flexible elongated member, and Tissue engagement member attached to the aforementioned flexible elongated member A locator system comprising the tissue engagement member, wherein the tissue engagement member is configured to fix the locator system to the target site by engaging with the tissue of the target site, A locator system in which the tissue engagement member is located near the beacon, or the beacon is located near the tissue engagement member.

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