Beacon devices, systems, and methods for medical procedures

Abstract

A positioning system has a flexible elongate delivery device, such as a flexible guidewire, advanced separately from a beacon element of the system to a target location. The beacon element may be configured not to extend beyond the periphery of the housing on which it is mounted, thereby reducing the overall cross-sectional profile of the system beacon portion. The beacon element may be mounted relative to the housing for imaging in a direction transverse to the longitudinal axis of the system. The beacon elements may include one or more light emitting diodes (LEDs) or other elements that may be imaged from locations other than the target location.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 410,679, filed on September 28, 2022, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0002] The present disclosure generally relates to devices, systems and methods for use when performing surgery (e.g., endoscopic surgery) in vivo. More specifically, the present disclosure generally relates to devices, systems and methods for locating anatomical locations in a patient's body. Even more specifically, the present disclosure relates to devices, systems and methods for facilitating delivery of a positioning device to an anatomical location in a patient's body. Background Art

[0003] It may be difficult to observe, locate and operate anatomical structures, devices and / or anatomical structures containing one or more devices from within the body. During in vivo surgery (e.g., endoscopic surgery performed in a body cavity without cutting the body), medical professionals may need to locate specific anatomical structures and / or positions in the body. Due to lack of light or insufficient light, the presence of intervening anatomical structures, and / or the shape and / or structure of various parts of the body, it may be difficult to locate the required anatomical structures and / or positions in the body from another position inside or outside the body. For example, in a surgery performed in a body cavity (such as the intestine), there are long areas of anatomical structures that may be difficult to distinguish from outside the body. Various positioning devices can be deployed in the body. However, since various channels in the body are curved, it may be challenging to deploy positioning devices through such curved channels through the cavity. For example, the pushability and tracking of the device through a curved body channel (such as through the intestine) may pose challenges. The device may not be properly advanced, and / or may be folded back and retreated instead of advancing. In view of these and other considerations, the present disclosure may be useful. Summary of the invention

[0004] The present disclosure is intended to introduce in simplified form a series of concepts that are further described in detail in the following specific embodiments. The present disclosure is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. Those skilled in the art will understand that the various aspects and features of the present disclosure may be used alone in some cases, and in other cases may be used in combination with other aspects and features of the present disclosure, regardless of whether this is described in the present disclosure. The inclusion or exclusion of elements, components, etc. in the present disclosure is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of the present disclosure, a positioning system includes: a housing having a guide lumen extending therethrough, the guide lumen being configured to advance the housing on a flexible, elongated delivery device to a target location within a patient's body; and a beacon element being configured to be imaged by an imaging system remote from the target location.

[0006] In some embodiments, the housing has a wall defining a hollow interior within the housing; a window is provided in the housing wall; and the beacon element is located within the housing so as to be located through the window. In some embodiments, the beacon element transmits a signal radially outward relative to a positioning system through the window. In some embodiments, a sleeve is provided around the beacon element and the window to secure (hold) the beacon element within the housing, the sleeve allowing imaging of the beacon element. In some embodiments, a power supply lumen extends through the housing, the power supply lumen being configured for passage of a power supply connection from a power source to the beacon element through the power supply lumen.

[0007] In some embodiments, a beacon support is mounted at a distal end of the housing and the beacon element is mounted on the beacon support. In some embodiments, the beacon element is mounted on the beacon support for imaging from multiple radial directions relative to the positioning system. In some embodiments, the beacon support includes a platform and the beacon element is mounted on the platform.

[0008] In some embodiments, the housing has a cross-sectional area, and the beacon is located within the cross-sectional area of ​​the housing.

[0009] In some embodiments, the housing is formed as an extrusion.

[0010] In some embodiments, the beacon element is a light source.

[0011] According to various principles of the present disclosure, a positioning system includes: a housing having a guide lumen extending therethrough; a beacon element associated with the housing and configured to be positioned by an imaging system remote from a target location; and a flexible, elongated delivery device. In some aspects, the flexible, elongated delivery device is slidably insertable into the guide lumen, and the housing is slidable on the flexible, elongated delivery device to be advanced to a target location in a patient's body independently of the flexible, elongated delivery device.

[0012] In some embodiments, the housing has a wall defining a hollow interior within the housing; a window is provided in the housing wall; and the beacon element is located within the housing so as to be imaged through the window.

[0013] In some embodiments, a beacon bracket is mounted at a distal end of the housing, and the beacon element is mounted on the beacon bracket.

[0014] In some embodiments, the housing has a cross-sectional area, and the beacon is located within the cross-sectional area of ​​the housing.

[0015] According to various principles of the present disclosure, a method for locating a target location in a patient's body from a position away from the target location comprises: advancing the distal end of a flexible, elongated transport device to the target location; advancing a housing with a beacon element on the flexible, elongated transport device and reaching the distal end of the flexible, elongated transport device located at the target location; and imaging the beacon element from a position different from the target location.

[0016] In some aspects, the method further includes causing the beacon element to emit an optical signal radially relative to the housing.

[0017] In some aspects, the method further includes causing the beacon element to emit light signals from a plurality of radial directions relative to the housing.

[0018] In some aspects, the beacon element is located within a cross-sectional area of ​​the housing, and the method further comprises imaging the beacon element radially relative to the housing.

[0019] In some embodiments, the method further comprises imaging the distal end of the flexible, elongated delivery device and the housing to advance the housing to the distal end of the flexible, elongated delivery device at the target location.

[0020] These and other features and advantages of the present disclosure will be apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in the form of multiple aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Non-limiting embodiments of the present disclosure are described by way of example and with reference to the accompanying drawings, which are schematic and not drawn to scale. The accompanying drawings are for illustrative purposes only, and the dimensions, positions, orders, and relative sizes shown therein may vary. For example, the device may be enlarged to see the details, but its actual size may be reduced relative to, for example, the size of the device that fits within the working channel of a delivery catheter or endoscope. In the accompanying drawings, identical or nearly identical or equivalent elements are generally represented by the same reference characters, similar elements are generally represented by similar reference numbers that differ by 100, and repeated descriptions will be omitted. For the sake of clarity and brevity, not every element in each of the accompanying drawings is marked, and not every element of each embodiment is shown where it is not necessary for a person of ordinary skill in the art to understand the present disclosure.

[0022] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements, as follows:

[0023] Figure 1 A perspective view of one embodiment of a positioning system formed in accordance with various aspects of the present disclosure is shown positioned within a schematically represented gastrointestinal tract environment.

[0024] Figure 2 A perspective view of one embodiment of a positioning system formed in accordance with various aspects of the present disclosure is shown.

[0025] Figure 3 A perspective view of a housing is shown of one embodiment of a positioning system formed in accordance with various aspects of the present disclosure.

[0026] Figure 4 Shows Figure 2 A perspective view of a modified version of the positioning system is shown.

[0027] Figure 5 Shown is a perspective exploded view of another embodiment of a positioning system formed according to various principles of the present disclosure.

[0028] Figure 6 Shows Figure 5 A perspective view of the assembled positioning system and beacon components.

[0029] Figure 7 Shows Figure 6 End view of the positioning system in. DETAILED DESCRIPTION

[0030] The following detailed description should be read in conjunction with the accompanying drawings, which depict illustrative embodiments. It should be understood that the present disclosure is not limited to the specific embodiments described, as these embodiments may vary. All devices, systems and methods discussed herein are examples of devices, systems and methods implemented according to one or more principles of the present disclosure. Each embodiment is provided by way of explanation, not the only way to implement these principles, but only as an example. Therefore, references to elements, structures or features in the accompanying drawings should be understood as references to examples of embodiments of the present disclosure, and should not be understood as limiting the present disclosure to the specific elements, structures or features shown. After reading this disclosure, a person of ordinary skill in the art will think of other ways to implement the disclosed principles. In fact, it will be apparent to those skilled in the art that various modifications and changes can be made to the present disclosure without departing from the scope or spirit of the present disclosure. For example, a feature shown or described as part of an embodiment can be used in combination with another embodiment to produce a further embodiment. Therefore, it is intended that the present subject matter covers such modifications and changes that fall within the scope of the appended claims and their equivalents.

[0031] It should be understood that the present disclosure is set forth in various levels of detail in this application. In some cases, details that are not necessary for a person of ordinary skill in the art to understand the present disclosure, or details that would make other details difficult to understand, may have been omitted. The terms used herein are only used to describe specific embodiments and are not intended to be limited beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as meanings commonly understood by a person of ordinary skill in the art to which the present disclosure belongs. According to the present disclosure, all devices and / or methods disclosed and claimed herein can be manufactured and implemented without undue experimentation.

[0032] As used herein, "proximal" refers to the direction or position closest to the user (medical professional, clinician, technician, operator, physician, etc., these terms are used interchangeably herein without limitation, including automated control systems, etc.), such as when the device is in use (e.g., when the device is introduced into the patient's body, implanted, positioned or delivered), and / or the direction or position closest to the delivery device; "distal" refers to the direction or position farthest from the user, such as when the device is in use (e.g., when the device is introduced into the patient's body, implanted, positioned or delivered), and / or the direction or position closest to the delivery device. "Longitudinal" refers to extending along the longer or larger dimension of an element. "Longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and if the element is bent or bent, it does not necessarily maintain a fixed configuration; "axial" generally refers to the direction along the longitudinal axis. However, it should be understood that references to axial or longitudinal movement of the above-mentioned system or its elements are not necessarily strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" means at least roughly bisecting a center point and / or being roughly equidistant from a periphery or border; "central axis" means, for an opening, a line that at least roughly bisects a center point of an opening, which extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a passage, a cavity or a hole. As used herein, "lumen", "channel", "hole" or "passageway" is not limited to a circular cross-section. It should be understood that references to body passages include naturally occurring passages (e.g., pylorus) and medically created passages (e.g., passages created using medical devices, such as between the stomach and the jejunum), etc. As used herein, the "free end" of an element refers to a terminal beyond which the element does not extend. It should be understood that terms such as at an end, on an end, adjacent to an end, or along an end are used interchangeably herein, are not intended to be limiting, unless otherwise stated, and are intended to represent a general relative spatial relationship, rather than a precisely defined position. Finally, references to "at" a position or location are intended to include that position or location and its vicinity (e.g., along, adjacent, etc.).

[0033] The present disclosure relates to devices, systems and methods useful in performing surgery (e.g., but not limited to endoscopic surgery, laparoscopic surgery and / or open surgery) in vivo, the method comprising first identifying a target location for surgery using a positioning system, deploying the positioning system at the target location, and then positioning the positioning system (e.g., at a later time) so as to perform surgery at the desired target location identified by the positioning system. Many medical surgeries require identifying the location of an anatomical structure (e.g., an organ or tissue wall), and then delivering a medical device to a second, different anatomical location to perform surgery on or at the first identified location. Herein, the first identified location may be interchangeably referred to as a "target location", "target site", "treatment site", "deployment site", "target tissue", "target tissue site", etc., without any intention to limit. The second anatomical location or site may be interchangeably referred to as a different anatomical location, a separate anatomical location, an imaging location, a positioning location, an entry location, etc., herein, without any intention to limit. As can be understood, the terms "site" and "position" are used interchangeably herein, without any intention to limit. In general, the principles of the present disclosure are applied to target locations and different anatomical locations in a patient's body. For example, the target location and the imaging location may be separated by a tissue wall, and / or may be located in different body organs or cavities. It should be understood that references to "at" a target tissue site are intended to include the target tissue and tissues in its vicinity (eg, along, adjacent, etc.), and are not limited to only the target tissue.

[0034] Non-limiting examples of procedures performed relative to a target location different from the imaging location include various medical procedures that involve moving a tissue wall (e.g., a body cavity wall or organ wall) to a desired location, such as relative to another tissue wall (e.g., a body cavity wall or organ wall). For example, various procedures may be performed by accessing the gastrointestinal (GI) tract, passing through a first organ or structure (e.g., the esophagus, stomach, duodenum, small intestine, large intestine, or peritoneal cavity), and delivering an anchor or stent to an adjacent organ, lumen, or tissue structure (e.g., an adjacent portion of the GI tract, bile duct, pancreatic duct, gallbladder, pancreas, cyst, pseudocyst, abscess, etc.). Typically, it is necessary to penetrate an entry tissue wall (e.g., a wall of a first organ or a first body cavity) at the entry location, establish a pathway through the wall to the target location, and penetrate a second tissue wall (e.g., a wall of a second organ or a second body cavity) at, along, or adjacent to the target location to perform the procedure at that location. Tissue anchors, stents, or other devices may be deployed between / across adjacent body cavities, organs, or other structures, for example, to maintain the tissue walls thereof in place, and / or to create anastomoses as required by the procedure. In addition to stents, tissue anchors may be used to secure adjacent tissues or organs, for example, prior to stent deployment, and may be left in place after stent deployment.

[0035] Endoscopic surgery may be advantageous over open surgery (involving incisions into the patient's body to gain access to the patient's body and internal anatomical structures) or laparoscopic surgery (generally involving smaller incisions to gain access to the patient's body and internal anatomical structures) for a variety of reasons. For example, recovery time from open surgery and even laparoscopic surgery may be longer than from endoscopic surgery, which does not involve incisions but rather generally accesses internal anatomical structures through natural orifices and advances equipment, tools, devices, etc. transluminally to a target area. However, endoscopic surgery presents challenges in locating a target location from different anatomical locations within a patient's body. According to various principles of the present disclosure, a positioning element and / or an associated positioning system is deployed at a target location to identify the target location from different anatomical locations.

[0036] An example of a common endoscopic procedure that presents challenges in identifying a target location is gastric bypass surgery, in which a connection (e.g., anastomosis) is created between the stomach and a specific portion of the intestine via a gastrojejunostomy. For example, by bypassing a portion of the duodenum (e.g., by creating an anastomosis between the stomach and small intestine at a location approximately 150 cm or more distal to the pylorus, to a distal portion of the duodenum, or to the jejunum), the disease state may be improved. In gastric outlet obstruction, the goal of a gastrojejunostomy is to drain gastric contents into the jejunum below / distal to the obstructed and / or dysfunctional duodenum. Gastrojejunostomy may also be used as a minimally invasive and potentially reversible treatment option for patients with metabolic disease by creating an anastomosis between the stomach and jejunum to bypass the duodenum, thereby producing a desired metabolic effect. In this way, absorption of gastric contents (e.g., food and other nutrients) in the duodenum may be bypassed and nutrients in these contents may not be absorbed, or absorption or uptake may be delayed as these contents pass from the stomach through the small intestine, promoting weight loss in patients and potentially controlling or resolving type 2 diabetes.

[0037] Endoscopic procedures such as gastrointestinal anastomosis present various challenges, including the need to locate the desired anatomical location (e.g., in the intestine) through tissue walls under endoscopy, such as in different anatomical locations (e.g., through the stomach cavity). Ultrasound and / or fluoroscopic procedures can provide images through anatomical walls (e.g., the stomach wall and intestinal wall). However, while ultrasound is useful for imaging tissue, it may not be able to image inorganic materials used to identify tissue as easily as ultrasound. While fluoroscopy is suitable for viewing dense materials (such as those made of medical devices), contrast agents used with fluoroscopy may dissipate while locating the target tissue and may need to be reintroduced.

[0038] Using a positioning system at the target location helps to identify the target location from different anatomical locations in the patient's body. Various positioning systems include positioning elements (e.g., beacons, such as light sources or other signal generators or other elements that can be identified by imaging technology). The positioning element is inserted (e.g., by an endoscope) into the desired location of the operation (e.g., the location where the intestinal tract is expected to be connected to the stomach). The endoscope is then withdrawn, leaving the positioning element in place. The endoscope is then advanced to the imaging position (optionally, after the endoscope is removed from the patient and the positioning system, it is reinserted). One or more instruments for performing the operation are inserted and passed through the endoscope through the endoscope, such as making an incision at the imaging position to enter the target location (e.g., entering the peritoneum through the stomach wall). It should be understood that terms such as "instrument", "tool", "device" and the like are used interchangeably in this article and are not intended to be limited. By using endoscopic visualization or otherwise positioning the positioning element to identify the target site of the operation, the operation can be performed at the desired target site. For example, once entering the stomach, the doctor locates the desired part of the small intestine with the help of a positioning element in the small intestine (e.g., a positioning element visible from the outside of the intestinal wall). The small intestine is accessed by cutting through the stomach wall and extending a grasper through the peritoneum to grasp the small intestine and then draw it toward the stomach. A stent can then be deployed to connect the small intestine and stomach, creating an anastomosis.

[0039] Although the positioning system can be delivered endoscopy, in some cases, the endoscope cannot easily reach the target location. For example, for a gastrojejunostomy, the target location in the jejunum may be too far away for the endoscope to easily reach. The positioning system can be deployed from the distal end of the endoscope via a guidewire. However, the use of a guidewire to deliver the positioning system may present various challenges. For example, a certain degree of rigidity is required to support and / or convey the positioning element. Additionally or alternatively, the thickness and / or rigidity of the final positioning system and its delivery system (with a guidewire) may make the positioning system difficult to maneuver in a tortuous body passage (e.g., through the small intestine).

[0040] The present disclosure describes solutions to the challenges of the above-mentioned existing positioning devices, systems and methods. According to various principles of the present disclosure, positioning devices, systems and methods include positioning elements that are independent of guidewire deployment. In some aspects, the positioning element is installed on a housing that can be guided on a flexible elongated element (e.g., guidewire) that is transported separately. More specifically, the housing can have a lumen through which the flexible elongated element can pass, so that the positioning element can be guided to a target position on the flexible elongated element. As described above, it will be appreciated by those of ordinary skill in the art that existing positioning systems include guidewires on which positioning elements are installed. Such guidewires must be selected to have sufficient rigidity and thickness to fully support and carry the positioning element to the target position. By arranging a positioning element on a housing that can be guided on a separate flexible elongated element, a thinner and more flexible elongated element can be used than when the positioning element is installed on the flexible elongated element and transported together with it. The thin, flexible elongated element can be easily navigated to the desired target position by any known or hitherto known method, and then the separate positioning element can be guided to the target position on the flexible elongated element. In some embodiments, the housing of the positioning element is less flexible than the flexible elongated element so that the positioning element can be advanced on the flexible elongated element, thereby facilitating the positioning element to advance on the flexible elongated element. The housing can be an extrusion, such as a flexible tubular element, which can be extended on a separately inserted flexible elongated element to guide the housing to a target site. In some embodiments, the proximal end of the housing proximally extends outside the patient's body, such as for controlling the advancement of the housing and / or fixing the position of the housing at the target site. In some embodiments, the housing will not extend too far so as to proximally extend outside the patient's body. It should be understood that the term "housing" is used for convenience and is used to refer to a housing or other type of element (in contrast to a flexible elongated element such as a guide wire) in which a positioning element can be provided, without intending to limit its specific longitudinal range.

[0041] In some aspects, a positioning element of a positioning system formed according to various principles of the present disclosure has a low profile relative to the system to facilitate delivery to a target location. In some aspects, the position and orientation of a positioning element on a positioning system formed according to various principles of the present disclosure increases the visible range of the positioning element, thereby improving the visualization and identification of the positioning element by an imaging system at an imaging location.

[0042] It should be understood that the positioning devices, systems and methods formed according to the various principles of the present disclosure can be used with various other devices, systems and methods for performing surgery in a patient, not just those disclosed herein. Therefore, although the devices, systems and methods described herein are described with respect to the gastrointestinal system, it is understood that the devices, systems and methods according to the present disclosure may also be advantageous for use in any other surgery. In addition, it should be understood that the devices, systems and methods described herein can be used with other areas of the anatomy, such as anywhere selective positioning of tissue or blind positioning through other tissue walls is required.

[0043] Various embodiments of the positioning device, system and method will now be described with reference to the examples shown in the accompanying drawings. References to "one embodiment", "embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that one or more specific features, structures, concepts and / or characteristics according to the principles of the present disclosure may be included in association with the embodiment. However, such references do not necessarily mean that all embodiments include specific features, structures, concepts and / or characteristics, or that one embodiment includes all features, structures, concepts and / or characteristics. Some embodiments may include various combinations of one or more such features, structures, concepts and / or characteristics. It should be understood that one or more features, structures, concepts and / or characteristics described with reference to one embodiment may be combined with one or more features, structures, concepts and / or characteristics of other embodiments. That is, any features, structures, concepts and / or characteristics described herein may be mixed and matched to create a hybrid embodiment, and such a hybrid embodiment is within the scope of the present disclosure. In addition, the various features, structures, concepts and / or characteristics of the disclosed embodiments may be independent and separate from each other, and may be used alone or in various combinations with each other to create alternative embodiments that are considered to be part of the present disclosure. Therefore, the present disclosure is not limited to the embodiments specifically described herein, because it would be too cumbersome to describe all possible combinations and sub-combinations of features, structures, concepts and / or characteristics, and the implementation examples disclosed herein are not intended to limit the broader aspects of the present disclosure. Finally, it should be understood that the various dimensions provided herein are examples, and a person of ordinary skill in the art can easily determine the standard deviation and the appropriate range of acceptable variations (e.g., considering nominal dimensions, shapes, stress / strain factors, etc.), which are all within the scope of the present disclosure and its related claims. The following description is merely an illustrative example of an embodiment and is not intended to limit the broader aspects of the present disclosure.

[0044] It should be understood that common features in the drawings are identified by common reference elements, and for the sake of brevity and convenience, without limitation, the description of common features will not generally be repeated. For clarity, not all components with the same reference number are numbered. It should be understood that in the following description, similar elements or components (reference numbers greater than 100) in various illustrative embodiments are generally designated by the same reference number plus a multiple of 100, and repeated descriptions are generally omitted for the sake of brevity. In addition, certain features in one embodiment can be used across different embodiments and are not necessarily individually labeled when they appear in different embodiments.

[0045] Now turning to the attached figure, Figure 1 An example of an embodiment of an environment in which a positioning system 100 formed according to various principles of the present disclosure can be used is shown. The positioning system 100 includes a positioning device 110 that is delivered to a desired target site TS with the assistance of a flexible elongated element 120. The positioning device 110 can be any device that can be positioned by an imaging system or other positioning system, such as a light source (e.g., a light emitting diode LED), and for convenience, it is referred to herein as a beacon device 110 without any intention of limitation. Figure 1 In the example shown, the beacon device 110 is delivered to a portion of the patient's jejunum J so that it is juxtaposed with a portion of the patient's stomach S. As can be appreciated, the flexible elongated member 120 must navigate a tortuous path through the various turns of the jejunum J.

[0046] According to various principles of the present disclosure, in order to facilitate navigation of the flexible elongated element 120 to the target site TS, the flexible elongated element 120 is a highly flexible elongated element, such as a flexible guide wire known to those of ordinary skill in the art (e.g., a guide wire that can be used for endoscopic surgery, whose outer diameter is less than about 0.035 inches (0.889 mm)). In addition, according to various principles of the present disclosure, the flexible elongated element 120 can be delivered to the target site TS independently of the beacon device 110 and before it. The flexible elongated element 120 may be referred to herein as a flexible elongated transport device 120 to highlight the difference that the element is delivered separately from the beacon device 110. Therefore, the flexible elongated transport device 120 can navigate and bend in a tortuous path as needed during navigation to the target site TS without being hindered by any possible obstruction caused by the provision of the beacon device 110 on the flexible elongated transport device 120.

[0047] Further in accordance with various principles of the present disclosure, the beacon device 110 is mounted relative to the housing 130, which is configured to be delivered to the target site TS with the assistance of the flexible elongated transport device 120. More specifically, the housing 130 is configured to be delivered on (and along) the flexible elongated transport device 120. Even more specifically, with reference to Figure 2As will be appreciated, the housing 130 includes a guide lumen 133 extending therethrough, which is configured to slidably receive the flexible elongated transport device 120. The guide lumen 133 may extend generally along the longitudinal axis LA of the positioning system 100. The flexible elongated transport device 120 may be slidably inserted into the guide lumen 133, and the housing 130 may be advanced distally over the flexible elongated transport device 120 into the patient's body until the target site TS is reached. As will be appreciated, the initial deployment of the flexible elongated transport device 120 and the separate deployment of the housing 130 make the positioning system 100 easier to operate and navigate than previous systems. The beacon device 110 does not increase the stiffness of the flexible elongated transport device 120 as in previous systems, so the flexible elongated transport device 120 can be easily navigated to the target site TS. The beacon device 110 is delivered proximal to the distal end 121 of the flexible elongated transport device 120. The distal end 121 of the flexible elongated transport device 120 can be sufficiently transported past the target site TS to reduce the risk of the beacon device 110 being pushed past the distal end 121 of the flexible elongated transport device 120 and detaching from the flexible elongated transport device 120. If the flexible elongated transport device 120 is a guidewire, the distal end 121 can be more flexible than the proximal region of the flexible elongated transport device 120 and can include a radiopaque marker 124 by which the housing 130 can be guided to advance on the flexible elongated transport device 120 and reach its distal end 121. In some embodiments, the positioning system 100 can also include a radiopaque marker 134 disposed relative to the beacon device 110 (e.g., on its housing 130) to facilitate positioning of the beacon device 110 relative to the distal end 121 of the flexible elongated transport device 120 and the target site TS during the delivery of the beacon device 110, for example, with the aid of a fluoroscopic or other imaging system.

[0048] The beacon device 110 may include a beacon housing 112 on which one or more beacon elements 114, 116 are mounted. In embodiments where the beacon device 110 is externally powered (e.g., connected to an external power source external to the patient's body via a wire), such as Figure 2 and Figure 3 As shown, the housing 130 also includes a power supply lumen 135 (e.g., extending approximately along the longitudinal axis LA of the positioning system 100), through which a power supply connector (e.g., a wire) for powering the beacon device 110 can extend proximally to a power source (e.g., outside the patient's body).

[0049] Other features of the positioning system 100 formed according to various principles of the present disclosure can be configured to improve navigation of the positioning system 100 to the target site TS. For example, in addition to increasing the flexibility of the positioning system delivery device to improve navigation in tortuous body passages, the positioning system 100 formed according to various principles of the present disclosure can also be configured to minimize its cross-sectional area and / or improve smooth delivery to the target site TS. Figure 2 The example embodiment of the positioning system 100 shown and the example embodiment of the housing 130 of the positioning system 100 shown separately ( Figure 3 ) As will be appreciated, the housing 130 includes a hollow interior 137 and a window 132 extending through the wall of the housing 130 and adjacent the distal end 131 of the housing 130. The window 132 forms a lateral passageway to the hollow interior 137. In this embodiment, the beacon device 110 is mounted relative to the housing 130 such that a beacon generating portion (e.g., an LED) of the beacon device 110 is visible through the window 132. Positioning the beacon device 110 within the hollow interior 137 of the housing 130 allows the beacon device 110 to fit generally within the cross-sectional profile of the locating system housing 130 (without extending beyond the cross-sectional profile or perimeter of the housing 130) with minimal, if any, effect on the cross-sectional dimensions of the locating system housing 130. This configuration allows the overall cross-sectional profile or dimensions of the locating system 100 to be minimized compared to locating systems in which the beacon is mounted above the housing or other transport device thereof. For example, the beacon device 110 does not protrude more than a few millimeters or fractions of a millimeter from the outer wall of the housing 130, so that the positioning system 100 has an atraumatic outer surface and its navigation is not affected by the beacon device 110. In some embodiments, the outer diameter of the positioning system 100 is selected based on the inner diameter of the working channel of the endoscope through which the positioning system 100 is delivered. For example, in some embodiments, the outer diameter of the positioning system 100 is less than about 3.7 mm. In some aspects, a sleeve 140 is provided over the window 132 and the beacon device 110 to fix the beacon device 110 in place relative to the window 132 and / or to provide a smooth, atraumatic surface for the tissue at the location of the beacon device 110 on the positioning system 100. The sleeve 140 can be formed of a transparent / translucent / transparent / translucent material that allows the beacon device 110 to be positioned therethrough (e.g., a light-transmissive material). Additionally or alternatively, the sleeve 140 may be formed from a flexible material, such as a heat shrink polymer, to facilitate positioning of the sleeve 140 on the beacon device 110 and the housing 130 .

[0050] exist Figure 4In the illustrated modified embodiment example of the positioning system 10 , the sleeve 140 extends over the distal end 131 ′ of the housing 130 , and / or the distal end 131 ′ of the housing 130 is itself configured to form a blunt, atraumatic distal end 131 ′ of the positioning system 100 . Figure 4 The remaining components of the positioning system 100 are shown in FIG. Figure 2 The elements of the illustrated positioning system 100 are similar and are labeled with the same reference numerals, and for the sake of brevity reference is made to the above description thereof.

[0051] According to various principles of the present disclosure, such as Figure 2 and Figure 4 The beacon device 110 is shown positioned to transmit signals generally radially relative to the positioning system 100 and its housing 130 and the flexible elongated delivery device 120. This radial transmission helps to accurately locate the position of the positioning system 100 and the target site TS from the imaging position. In some embodiments, the positioning system formed according to various principles of the present disclosure can include multiple beacon elements to enhance the localizability of the positioning system 100 by the imaging system. For example, Figure 2 or Figure 3 The housing 130 of the illustrated positioning system 100 may include a plurality of windows 132 to allow the plurality of beacon devices 110 to transmit signals from a plurality of directions relative to the positioning system 100 , the housing 130 , and / or the flexible elongated transport device 120 .

[0052] The above-mentioned various principles of the present disclosure can be implemented in other ways. For example, Figure 5 , Figure 6 and Figure 7 Another example embodiment of a positioning system 200 is shown, which has a beacon device 210 that can be transported separately from a flexible elongated transport device 220. Similar to the positioning system 100 described above, Figure 5 , Figure 6 and Figure 7 The flexible, elongated transport device 220 of the illustrated positioning system 200 can be transported independently of and ahead of the beacon device 210. Thus, the flexible, elongated transport device 220 of the positioning system 200 can be thinner than similar components of prior art positioning systems that must be able to support a beacon device or element thereon.

[0053] Also similar to the above positioning system 100, Figure 5 , Figure 6 and Figure 7 The positioning system 200 is shown configured to be delivered separately from, for example, over, a previously delivered flexible elongated delivery device 220 of the positioning system 200. Figure 5As shown, the main housing 230 of the positioning system 200 can be formed similar to the housing 130 of the positioning system 100 described above, and includes at least one guide lumen 233, through which the flexible elongated delivery device 220 can pass. The main housing 230 can be advanced on a previously delivered flexible elongated delivery device 220 in a manner similar to the positioning system 100 described above (specifically, the guide lumen 233 is mounted on the flexible elongated delivery device 220). In some aspects, the main housing 230 is a flexible tubular element. In some embodiments, the proximal end of such a flexible tubular element extends proximally out of the patient's body, although other lengths of the main housing 230 are also within the scope and spirit of the present disclosure.

[0054] Also similar to the positioning system 200 described above, according to various principles of the present disclosure, the beacon device 210 is mounted relative to the housing 230 to minimize the cross-sectional profile of the positioning system 200. More specifically, as shown in FIG. Figure 5 As shown, the positioning system 200 includes a main housing 230, and the beacon device 210 is supported / mounted on a beacon bracket 250 located at the distal end 231 of the main housing 230. The beacon bracket 250 provides a structure so that the beacon device 210 can be mounted roughly within the cross-sectional profile of the positioning system housing 230, with minimal impact, if any, on the cross-sectional size of the positioning system housing 230. Figure 5 , Figure 6 and Figure 7 In the illustrated embodiment, the beacon support 250 includes a platform 252 on which the beacon device 210 is mounted. Figure 6 and Figure 7 The platform 252 extends distally from the beacon bracket 250 and can be positioned to be generally maintained within the cross-sectional outline boundaries of the main housing 230 (i.e., not protruding beyond), and the beacon device 210 is also maintained within the cross-sectional outline boundaries of the main housing 230, as shown. Figure 7 As shown. The platform 252 can have a rounded distal shape to form an atraumatic tip that can optionally facilitate navigation of the main housing 230 to the target site TS. Figure 5 and Figure 7 It can be understood that the beacon bracket 250 includes a guide channel 253 connected to the guide tube cavity 233 of the main shell 230, and the flexible and slender transport device 220 can pass through the guide channel 253. The positioning system 200 (especially its beacon bracket 250) is installed on the flexible and slender transport device 220 through the guide channel 253.

[0055] In some embodiments, the platform 252 facilitates mounting of multiple beacon devices 210, enabling the beacon devices 210 to transmit signals from multiple radial directions relative to the positioning system 200, as shown in FIG. Figure 7For example, the beacon device 210 may have a beacon housing 212 with beacon elements 214 and 216 mounted on both sides thereof. Figure 6 and Figure 7 As shown. In some embodiments, the beacon elements 214, 216 may be different in nature and configured to transmit signals in different (e.g., opposite) directions, or otherwise be separately identifiable. In addition, the beacon bracket 250 may include a power channel 255 that allows access to the power supply lumen 235 through the main housing 230 so that the power supply connector (e.g., wires) is connected to the beacon device 210 through the main housing 230 and the beacon bracket 250. The platform 252 can be covered with a sleeve 240 (e.g., similar to the sleeve 140 described above) to secure the beacon device 210 in place relative to the beacon bracket 250. The beacon bracket 250 and the sleeve 240 can be configured to form a substantially blunt, non-traumatic shape at the distal end 201 of the positioning system 200, such as Figure 6 shown.

[0056] In some embodiments, the beacon bracket 250 is an end cap formed separately from the main housing 230 and mounted thereon. The beacon bracket 250 can be fixed to the distal end 231 of the main housing 230 by bonding (such as adhesive, welding, brazing, etc.), mechanical fixing (such as interference fit, friction fit, threaded connection, etc.), or using a separate structural element such as the above-mentioned sleeve 140, or other connecting elements such as heat shrink elements. In the illustrated embodiment example, the beacon bracket 250 includes a collar 254, which is configured to facilitate mounting the beacon bracket 250 on the distal end 231 of the main housing 230.

[0057] Either or both of the housings 130, 230 of the positioning systems 100, 200 described above may be formed as extrusions, such as tubular extrusions. The housings 130, 230 may be made of any of a variety of desired polymers, such as, but not limited to, polyethylene, polyether block amides (such as ), polyimide, polypropylene, and other polymers commonly used in medical device extrusions. The walls of the extrusions can be thin enough (depending on the material) to allow easy navigation in tortuous anatomical passages, while being thick and / or stable enough to provide structural stability to the positioning system 100, 200. For example, the thickness of the wall can be at least about 0.003 inches (0.0762 mm). The housings 130, 230 can be formed into respective lumens 133, 135, 233, 235 by an extrusion process. It should be understood that although the proximal openings of the lumens 133, 135, 233, 235 facilitate entry, the distal ends of the lumens 133, 135, 233, 235 can be closed in a variety of ways known to those of ordinary skill in the art.

[0058] The beacon devices 110, 210 of the above-mentioned positioning systems 100, 200 can be any desired device or element known or heretofore known to a person of ordinary skill in the art that can be identified and located by an imaging system. For example, the beacon devices 110, 210 may include one or more light emitting diodes (LEDs), such as the LED array described in U.S. Patent Application Publication US2021 / 0196106 "Device, System, and Method for Locating Body Cavity" published on July 1, 2021. In some embodiments, the LEDs have different wavelengths (such as colors) to facilitate imaging at different distances and / or using different imaging devices. In addition or alternatively, the beacon devices 110, 210 can be other types of signal emitting or visualization devices or elements known or heretofore known to a person of ordinary skill in the art, and the present disclosure is not limited in this regard.

[0059] It should be understood that, in addition to Figure 1-7 Except for some differences between the positioning systems 100 and 200 shown, the positioning systems 100 and 200 are substantially the same or similar in operation / use. Therefore, the same features have been identified by the same reference elements, and for the sake of brevity, the description of these same features will not be repeated. For clarity, not all components with the same reference number are numbered.

[0060] In use, the flexible, elongated delivery device 120, 220 of the positioning system 100, 200 formed according to various principles of the present disclosure is advanced so that its distal end 121, 221 is located at the target site TS in the patient's body. Typically (but not necessarily), the positioning system 100, 200 is delivered through the working channel 163 of the endoscope 160, such as Figure 1 As shown. Figure 1 In the illustrated example embodiment environment, the endoscope 160 is advanced through the patient's mouth, esophagus, and stomach (and optionally through the pylorus into the duodenum). Because not all endoscopes are long enough to extend to all target sites, the flexible elongated delivery device 120, 220 extends distally from the distal end 161 of the endoscope 160 and beyond the distal end to reach the target site. For example, Figure 1As shown, the distal end 161 of the endoscope 160 extends through the stomach S and through the pylorus P into the duodenum D, but may not extend far beyond the pylorus P. The flexible, elongated delivery device 120, 220 is advanced distally from the endoscope 160, through the duodenum, and into the patient's jejunum J. Once the distal end 121, 131 of the flexible, elongated delivery device 120, 220 is advanced and positioned at the target site TS, the flexible, elongated delivery device 120, 220 is fixed in place relative to the patient (e.g., by any means known to those of ordinary skill in the art, such as fixing the proximal end of the flexible, elongated delivery device 120, 220 to a fixture near the patient or to the patient). Then, the housing 130, 230 with the beacon device 110, 210 (and associated components) can be advanced over the flexible, elongated delivery device 120, 220. The outer dimensions of the housing 130, 230 (including the beacon device 110, 120) can be selected based on the inner diameter of the working channel 163 of the endoscope 160. For example, as described above, the outer dimensions of the housing 130, 230 (including the beacon device 110, 120) can be selected to fit within the working channel of the delivery device of the delivery positioning system 100, 200, for example, smaller than the inner diameter of a typical endoscope (e.g., about 3.7 mm). The inner diameter of the power supply lumen 135, 235 (in which at least a portion of the beacon device 110, 210 can be located) can be approximately 0.12 inches ± 0.01 inches (0.305 cm ± 0.02 cm). The inner diameter of the guide lumen 133, 233 within the housing 130, 230 can be selected based on the outer diameter of the flexible, elongated delivery device 120, 220 to be slidably inserted therein. For example, the inner diameter of the guide lumen 133, 233 can be approximately 0.027 inches ± 0.01 inches (0.686 mm ± 0.2 mm). The housing 130, 230 is guided over the flexible elongated transport device 120, 220 and advanced to the target site TS. The length of the housing 130, 230 can be selected to facilitate navigation in a tortuous body passage. For example, the length of the housing 130, 230 can be approximately 0.187 inches ± 0.05 inches (0.475 cm ± 0.1 cm). If desired, the housing 130, 230 of the positioning system 100, 200 is fixed in place relative to the target site TS, and the flexible elongated transport device 120, 220 is withdrawn. For example, if the proximal end of the housing 130, 230 extends proximally outside the patient, the proximal end can be fixed, for example relative to the patient or otherwise fixed (e.g., in a manner similar to the initial fixation of the flexible elongated delivery device 120, 220 to maintain the position of the beacon device 110, 210 relative to the target site TS). The endoscope 160 used to deliver the positioning system 100, 200 can be withdrawn and, optionally, then used to deliver an imaging system at another location within the patient's body to position the positioning system 100, 200.The beacon device 110, 210 is activated (or has been activated if activation is necessary) so that the positioning system 100, 200 can be identified from another location inside or outside the patient. Then, the imaging system capable of identifying / locating the positioning system 100, 200 is advanced to an anatomical location different from the target site TS to identify / locate the positioning system 100, 200 (e.g., its beacon device 110, 120) at the target site TS. The endoscope 160 can be withdrawn, and the instrument, tool, device, etc. (these terms are used interchangeably herein and are not intended to be limiting) can then be advanced through the working channel 163 of the endoscope 160. Further steps can then be performed depending on the treatment / surgery planned to be performed at the target site TS. The endoscope 160 can be completely withdrawn from the flexible, elongated delivery device 120, 220 so that the working channel 163 of the endoscope 160 provides a clear passage for other devices. In some embodiments, the positioning system 100, 200 can be anchored relative to the target site TS and the flexible elongated delivery device 120, 220 can be withdrawn without withdrawing the endoscope 160 from the flexible elongated delivery device 120, 220. The endoscope 160 can include a visualization device capable of visualizing the positioning system 100, 200, and / or additional imaging devices can be used to locate the positioning system 100, 200. For example, the endoscope 160 can be positioned in the stomach S to locate the target site TS in the jejunum J so as to form an anastomosis between the stomach S and the jejunum J (e.g., to perform a gastric bypass surgery). It should be understood that the positioning system 100, 200 and / or any components of the endoscope 160 can be controlled by a medical professional at its proximal end in a manner known to those of ordinary skill in the art.

[0061] Although embodiments of the present disclosure may be described with specific reference to medical devices, systems, and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods can be used to locate and treat tissues in the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. Although embodiments of the present disclosure may be described with specific reference to medical devices and systems (such as endoscopic devices, auxiliary tools, and / or guidewires) for the gastrointestinal system, it should be understood that the positioning devices and systems described herein can be used with various medical procedures performed in catheters, lumens, blood vessels, or body cavity anatomical structures, including, for example, interventional radiology procedures, balloon angioplasty / angiography procedures, thrombolytic procedures, urology or gynecology procedures, etc. The medical devices herein may include a variety of medical devices for navigating in body cavities, such as catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. The disclosed medical devices and systems can also be inserted through different access points and methods, such as percutaneous, endoscopic, laparoscopic, or a combination thereof.

[0062] In view of the above, it should be understood that the various embodiments shown in the drawings have several independent features, each of which has at least a unique benefit alone, which is desirable but not critical for the positioning device, system and method disclosed herein. Therefore, it is not necessary to have all the various features described herein to achieve at least some of the desired characteristics and / or benefits described herein. In the positioning device, system or method formed according to the various principles of the present disclosure, there may be only one of the various features. Alternatively, one or more features described with reference to an embodiment can be combined with one or more features of any other embodiment provided herein. That is, any feature described herein can be mixed and matched to create a hybrid design, and such a hybrid design is within the scope of the present disclosure. In addition, in the present disclosure, reference numbers are used to indicate the common elements or features of the disclosed embodiments. The same reference number can be used to indicate elements or features that are not identical in form, shape, structure, etc., but provide similar functions or benefits. Additional reference characters (such as letters, not numbers) can be used to distinguish elements or features that are similar to each other.

[0063] Those skilled in the art will appreciate that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the present disclosure.

[0064] All devices and methods discussed herein are examples of devices and / or methods implemented according to one or more principles of the present disclosure. These examples are not the only way to implement these principles, but are merely examples, and are not intended to limit the broader aspects of the present disclosure. Therefore, references to elements, structures or features in the accompanying drawings must be understood as references to examples of embodiments of the present disclosure, and should not be understood as limiting the present disclosure to the specific elements, structures or features shown. After reading the present disclosure, a person of ordinary skill in the art will think of other ways to implement the disclosed principles. It is obvious to a person of ordinary skill in the art that the disclosed devices, systems and / or methods, as well as the order of steps of the methods described herein, can be changed without departing from the concept, spirit and scope of the present disclosure. It should be understood that the various features generally described for one embodiment can be applied to another embodiment, whether or not explicitly stated. The various features described herein can be used alone or in any combination thereof. Therefore, the present invention is not limited to the embodiments specifically described herein, and all substitutions and modifications that are obvious to a person of ordinary skill in the art are considered to be within the spirit, scope and concept of the present disclosure defined by the appended claims.

[0065] The foregoing discussion has a wide range of applications and is presented for the purpose of illustration and description, without intending to limit the present disclosure to the form disclosed herein. It should be understood that various additions, modifications and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit and scope of the present disclosure. Specifically, it will be clear to those skilled in the art that the principles of the present disclosure can be embodied in other forms, structures, arrangements, proportions, and can be used with other elements, materials and components without departing from their concepts, spirits, scopes or characteristics. For example, in order to simplify the disclosure, the various features of the present disclosure are combined in one or more aspects, embodiments or configurations. However, it should be understood that the various features of certain aspects, embodiments or configurations of the present disclosure can be combined in alternative aspects, embodiments or configurations. Although the present disclosure is presented in the form of an embodiment, it should be understood that the various individual features of the present subject do not have to exist in full to achieve at least some desired characteristics and / or benefits or such individual features of the present subject. It will be appreciated by those skilled in the art that the present disclosure can be modified in many aspects of structure, arrangement, proportion, material, components, etc. in practice, which are particularly suitable for specific environments and operating requirements without departing from the principle, spirit or scope of the present disclosure. For example, an element shown as being integrally formed may be composed of multiple parts, an element shown as being multiple parts may also be integrally formed, the operation of the element may be reversed or otherwise changed, and the size or size of the element may also be changed. Similarly, although the operation, action or step is described in a particular order, this should not be understood as requiring that it must be performed in such a particular order, or that all operations, actions or steps must be performed to obtain the desired result. In addition, other embodiments are also within the scope of the appended claims. In some cases, the actions recorded in the claims can be performed in a different order and still obtain the desired result. Therefore, the embodiments disclosed at present should be regarded as illustrative and not restrictive in all respects, and the scope of the subject matter claimed is indicated by the appended claims, without being limited to the foregoing description or the specific embodiments or arrangements described or shown herein. In view of the foregoing, the individual features of any embodiment may be used alone and may be combined with the features of that embodiment or any other embodiment to claim rights, and the scope of the subject matter is indicated by the appended claims, without being limited to the foregoing description.

[0066] In the foregoing description and the following claims, the following should be understood. The phrases "at least one", "one or more", and "and / or", as used herein, are open expressions that are both connective and disjunctive in operation. The terms "one", "an", "the", "first", "second", etc. do not exclude plural forms. For example, the terms "one" or "an" entity used herein refer to one or more of the entity. Therefore, the terms "one" (or "one"), "one or more", and "at least one" can be used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally used in its meaning that includes "and / or", unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each structure, component, feature, etc. so connected, unless the context clearly indicates otherwise; the conjunction "or" includes one or other of the structures, components, features, etc. so connected, alone or in any combination and quantity, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, radial, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used only for identification purposes to help the reader understand the present disclosure, and / or to distinguish regions of related elements, and do not limit the related elements, particularly with respect to the position, orientation, or use of the present disclosure. Connection references (e.g., attachment, coupling, connection, engagement, and connection) should be interpreted broadly and may include intermediate members between sets of elements and relative movement between elements, including direct and indirect connections, unless otherwise indicated. Therefore, a connection reference does not necessarily mean that two elements are directly connected and fixedly associated with each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to indicate importance or priority, but are used to distinguish one feature from another.

[0067] The following claims are incorporated into this detailed description by reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises," "includes," "contains," and "covers" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, and the like. Furthermore, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not mean that the combination of features is not feasible and / or has no advantages. In addition, singular references do not exclude pluralities. Reference signs in the claims are provided merely as illustrative examples and should not be interpreted in any way as limiting the scope of the claims.

Claims

1. A positioning system, comprising: a housing having a guide lumen extending therethrough, the guide lumen being configured to advance the housing over a flexible, elongated delivery device to a target location within a patient; as well as A beacon element is associated with the housing and is configured to be imaged by an imaging system remote from the target location.

2. The positioning system according to claim 1, wherein: The housing has walls defining a hollow interior within the housing; A window is provided on the wall of the housing; and The beacon element is located within the housing so as to be positioned through the window.

3. The positioning system of claim 2, wherein the beacon element transmits a signal radially outward relative to the positioning system through the window.

4. The positioning system according to any one of claims 2-3, further comprising a sleeve surrounding the beacon element and the window to fix the beacon element within the housing, the sleeve allowing imaging of the beacon element therethrough.

5. A positioning system according to any one of claims 2 to 4, wherein a power supply lumen extends through the housing, the power supply lumen being configured for passage of a power supply connection from a power source to the beacon element therethrough. 6 . The positioning system according to claim 1 , further comprising a beacon bracket mounted at a distal end of the housing, the beacon element being mounted on the beacon bracket.

7. The positioning system of claim 6, wherein the beacon element is mounted on the beacon support for imaging from multiple radial directions relative to the positioning system.

8. A positioning system according to any one of claims 6-7, wherein the beacon support comprises a platform on which the beacon element is mounted.

9. The positioning system of any one of claims 1-8, wherein the housing has a cross-sectional area, and the beacon is located within the cross-sectional area of ​​the housing.

10. A positioning system according to any one of claims 1 to 9, wherein the housing is formed as an extrusion.

11. The positioning system according to any one of claims 1 to 10, wherein the beacon element is a light source.

12. A positioning system comprising: a housing having a guide lumen extending therethrough; a beacon element associated with the housing and configured to be located by an imaging system remote from the target location; as well as A flexible, elongated conveying device; The flexible and elongated transport device can be slidably inserted into the guide lumen, and the housing can slide on the flexible and elongated transport device to advance to a target position in the patient's body independently of the flexible and elongated transport device.

13. The positioning system according to claim 12, wherein: The housing has walls defining a hollow interior within the housing; A window is provided on the wall of the housing; and The beacon element is located within the housing so as to be imaged through the window.

14. The positioning system according to claim 12, further comprising a beacon bracket mounted at a distal end of the housing, the beacon element being mounted on the beacon bracket.

15. The positioning system of any one of claims 12-14, wherein the housing has a cross-sectional area, and the beacon is located within the cross-sectional area of ​​the housing.

Images