Beacon Devices, Systems, and Methods for Medical Procedures

Abstract

The locator system has a flexible, elongated delivery device, such as a flexible guidewire, that is advanced to the target site separately from the beacon element of the system. The beacon element may be configured so that it does not extend beyond the periphery of the housing to which it is attached, thereby reducing the overall cross-sectional profile of the beacon portion of the system. The beacon element may be attached transverse to the longitudinal axis of the system relative to the housing to be imaged. The beacon element may include one or more LEDs or other elements that allow imaging from a location remote from the target site.

Description

[Technical Field]

[0001] The present disclosure relates generally to devices, systems, and methods used in performing procedures within the body, such as endoscopic procedures. More particularly, the present disclosure relates generally to devices, systems, and methods used to identify anatomical sites within a patient's body. Even more particularly, the present disclosure relates to devices, systems, and methods that facilitate delivery of a locator device to an anatomical site within a patient's body. [Background technology]

[0002] Viewing, identifying, and manipulating anatomical structures, devices, and / or anatomical structures containing one or more devices from within the body can be difficult. During an intracorporeal procedure, such as an endoscopic procedure within a body lumen (not involving cutting the body open), a medical professional may need to identify a particular anatomical structure and / or location within the body. Identifying a desired anatomical structure and / or location within the body from elsewhere within or outside the body can be difficult due to a lack of or poor illumination and / or the intervening anatomical structures and / or the shape and / or configuration of various parts of the body. For example, procedures within a body lumen, such as the intestine, present long regions of anatomical structures that can be difficult to distinguish from outside the body. Various localization devices can be placed within the body. However, because various passageways within the body are tortuous, placing a localization device transluminally through such tortuous passageways can be difficult. For example, pushability and trackability of a device through a tortuous intracorporeal passageway, such as through the intestine, can present challenges. The device may not advance properly and / or may fold back instead of advancing. The present disclosure may be useful with respect to these and other considerations. Summary of the Invention

[0003] This Summary is provided to introduce a selection of concepts in a simplified form that are described in more detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that each of the various aspects and features of the present disclosure can be advantageously used separately in some instances, or in combination with other aspects and features of the present disclosure in other instances, whether or not described in this Summary. Neither the inclusion or absence of an element, component, or the like in this Summary is intended to limit the scope of the claimed subject matter.

[0004] In accordance with various principles of the present disclosure, a locator system includes a housing having a guide lumen extending therethrough and configured to advance the housing over a flexible, elongate delivery device to a target site within a patient's body, and a beacon element configured to be imaged by an imaging system spaced from the target site.

[0005] In some embodiments, the housing has a wall defining a hollow interior within the housing, a window defined through the housing wall, and the beacon elements disposed within the housing to be identified through the window. In some embodiments, the beacon elements emit signals radially outwardly through the window to a locator system. In some embodiments, a sleeve is disposed around the beacon elements and the window to hold the beacon elements within the housing, the sleeve enabling imaging of the beacon elements through the sleeve. In some embodiments, a power lumen extends through the housing configured for passage of a power connection through the housing from a power source to the beacon elements.

[0006] In some embodiments, a beacon support is attached to the distal end of the housing, and the beacon elements are attached to the beacon support. In some embodiments, the beacon elements are attached to the beacon support so as to be imageable from two or more directions radially relative to the locator system. In some embodiments, the beacon support includes a platform to which the beacon elements are attached.

[0007] In some embodiments, the housing has a cross-sectional area and the beacon is disposed within the cross-sectional area of ​​the housing. In some embodiments, the housing is formed as an extrusion.

[0008] In some embodiments, the beacon element is a light source. In accordance with various principles of the present disclosure, a locator system includes a housing having a guide lumen extending therethrough, a beacon element configured to be identified by an imaging system remote from a target site, and a flexible, elongate delivery device. In some aspects, the flexible, elongate delivery device is slidably insertable into the guide lumen, and the housing is slidable over the flexible, elongate delivery device so as to be advanced to the target site within a patient's body independently of the flexible, elongate delivery device.

[0009] In some embodiments, the housing has a wall defining a hollow interior within the housing, a window defined through the housing wall, and the beacon element positioned within the housing such that it is imaged through the window.

[0010] In some embodiments, a beacon support is attached to the distal end of the housing, and the beacon elements are attached to the beacon support. In some embodiments, the housing has a cross-sectional area and the beacon is disposed within the cross-sectional area of ​​the housing.

[0011] According to various principles of the present disclosure, a method for identifying a target site within a patient's body from a location remote from the target site includes advancing a distal end of a flexible, elongate delivery device to the target site, advancing a housing having a beacon element over the flexible, elongate delivery device and to the distal end of the flexible, elongate delivery device positioned at the target site, and imaging the beacon element from a location different from the target site.

[0012] In some aspects, the method further includes emitting an optical signal from the beacon element radially relative to the housing. In some aspects, the method further includes emitting optical signals from the beacon element in two or more directions radially relative to the housing.

[0013] In some aspects, the beacon elements are disposed within a cross-sectional area of ​​the housing, and the method further includes imaging the beacon elements radially relative to the housing. In some embodiments, the method further includes imaging the distal end of the flexible elongate delivery device and the housing to advance the housing to the distal end of the flexible elongate delivery device at the target site.

[0014] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that or any other embodiment.

[0015] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures therein may be altered. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in relative size, e.g., to fit within the working channel of a delivery catheter or endoscope. In the drawings, identical, nearly identical, or equivalent elements are typically represented by the same reference numeral, and similar elements are typically designated by different similar reference numerals that increment by 100, with redundant description omitted. For purposes of clarity and simplicity, not every element is labeled in every drawing, and not every element of every embodiment is shown, unless illustration is necessary to enable those skilled in the art to understand the present disclosure.

[0016] The detailed description will be better understood in conjunction with the following accompanying drawings, in which like reference numerals represent like elements and in which: [Brief explanation of the drawings]

[0017] [Figure 1] 1 illustrates a perspective view of an example of an embodiment of a locator system formed in accordance with various aspects of the present disclosure and disposed in a schematic representation of a gastrointestinal environment. [Figure 2] 1 illustrates a perspective view of an example of an embodiment of a locator system formed in accordance with various aspects of the present disclosure. [Figure 3] 1 illustrates a perspective view of an example housing of an embodiment of a locator system formed in accordance with various aspects of the present disclosure. FIG. [Figure 4] FIG. 3 shows a perspective view of a modified version of the locator system as shown in FIG. 2. [Figure 5] 1 illustrates a perspective exploded view of another example of an embodiment of a locator system formed in accordance with various principles of the present disclosure. [Figure 6]6 shows a perspective view of the locator system in FIG. 5 assembled with beacon elements. [Figure 7] 7 shows an end view of the locator system in FIG. 6. DETAILED DESCRIPTION OF THE INVENTION

[0018] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described, as such may vary. All devices, systems, and methods discussed herein are examples of devices, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided by way of illustration and is merely an example, not the only way, to implement these principles. Therefore, references to elements, structures, or features in the drawings should be understood as references to example embodiments of the present disclosure, and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Those skilled in the art will likely recall other examples of ways to implement the disclosed principles upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield yet further embodiments. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0019] It will be understood that the present disclosure has been described in various levels of detail in this application. In certain instances, details that are not necessary for those skilled in the art to understand the present disclosure or that would make it difficult for those skilled in the art to appreciate other details may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0020] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional, clinician, technician, operator, or physician, etc., such terms are used interchangeably herein without limitation and include an automated controller system or other manner) and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or when implanting, placing, or delivering the device), and "distal" refers to a direction or location furthest from a user and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or when implanting, placing, or delivering the device). "Longitudinal" means extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight, and does not necessarily maintain a fixed configuration when the element is bent or curved. Also, "axial" refers generally along the longitudinal axis. It will be understood, however, that references to axial or longitudinal movement of the above-described systems or their elements need not be strictly limited to axial and / or longitudinal movement along the longitudinal or central axis of the referenced elements. "Central" means, at least, generally intersecting the center point and / or generally equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line that at least generally intersects the center point of the opening and extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or bore. As used herein, "lumen" or "channel" or "bore" or "passageway" is not limited to a circular cross-section. References to bodily passageways will be understood to include naturally occurring passageways (e.g., the pylorus) as well as medically created passageways (e.g., passageways created by the use of medical instruments, such as between the stomach and jejunum), or otherwise. As used herein, a "free end" of an element is a terminal end beyond which such element does not extend.It will be understood that terms such as at, on, adjacent to, or along, etc., can be used interchangeably herein without limitation, unless otherwise stated, and are intended to indicate a general relative spatial relationship rather than a precisely defined location. Finally, reference to "at" a location or region is intended to include in the vicinity of and / or near (e.g., along, adjacent, etc.) such location or region.

[0021] The present disclosure relates to devices, systems, and methods useful in performing procedures, such as, but not limited to, endoscopic, laparoscopic, and / or open surgical procedures, within the body by first identifying a target site for treatment using a locator system, placing the locator system at the target site, and then (e.g., at a later time) locating the locator system to perform the procedure at the desired target site identified by the locator system. Many medical procedures require identifying the location of an anatomical structure, such as an organ or tissue wall, and then delivering a medical instrument to a second, different anatomical location to perform the procedure on or at the first identified location. The initially identified location may alternatively be referred to herein, without limitation, as a "target location," "target site," "treatment site," "deposition site," "target tissue," "target tissue site," etc. The second anatomical location or site may be referred to interchangeably herein, without limitation, as a different anatomical location, a separate anatomical location, an imaging site, a localization site, an access site, etc. As can be appreciated, the terms site and location can be used interchangeably herein without any limitation. Typically, the principles of the present disclosure are applied with respect to a target location and a different anatomical location identified within a patient. For example, the target location and the imaging location can be separated by a tissue wall and / or can be within different body organs or cavities. It will be understood that references "at" a target tissue site are intended to include tissue in the vicinity of and near (e.g., along, adjacent, etc.) the target tissue, and are not limited to only the target tissue.

[0022] Non-limiting examples of procedures that may be performed on a target location different from the imaging location include various medical procedures that involve moving a tissue wall (e.g., a body lumen wall or organ wall) to a desired position, such as relative to another tissue wall (e.g., a body lumen wall or organ wall). For example, various procedures may be performed by entering the gastrointestinal (GI) tract 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 or 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 both the access tissue wall at the access location (e.g., the wall of a first organ or first body lumen) through which access to the target location is established and a second tissue wall (e.g., the wall of a second organ or second body lumen) along, adjacent to, or at the target location where the procedure is to be performed. Tissue anchors or stents or other devices may be placed between / across adjacent body lumens, organs, or other structures, as indicated in the procedure, to thereby maintain the tissue walls in apposition and / or create an anastomosis. Tissue anchors may be used in addition to stents to secure adjacent tissues or organs, such as before the stent is placed, and can be left in place after the stent is placed.

[0023] Endoscopic procedures may be preferable to open surgical procedures (which involve cutting open a patient's body to gain access to the patient's body and internal anatomical structures) or laparoscopic procedures (which typically involve smaller incisions to gain access to the patient's body and internal anatomical structures) for a variety of reasons. For example, open surgical procedures or even laparoscopic procedures may involve longer recovery times than endoscopic methods, which do not involve incisions but instead typically access internal anatomical structures through natural orifices and transluminally advance instruments, tools, devices, etc. to the target area. However, endoscopic procedures present challenges with regard to identifying target locations from different anatomical locations within a patient's body. In accordance with various principles of the present disclosure, locator elements and / or associated locator systems are placed at target locations to identify the target locations from different anatomical locations.

[0024] One example of a common endoscopic procedure that presents challenges in identifying target locations is a gastric bypass procedure, in which a connection, such as an anastomosis, is created between the stomach and a portion of the intestine through a gastrointestinal anastomosis. For example, disease conditions can benefit from bypassing a portion of the duodenum, such as by creating an anastomosis between the stomach and small intestine (using a distal portion of the duodenum or using the jejunum) approximately 150 cm or more away from the pylorus. In gastric pyloric obstruction, a gastrojejunostomy serves the purpose of draining stomach contents into the jejunum below / distal to the obstructed and / or dysfunctional duodenum. Gastrojejunostomy procedures can also serve as a minimally invasive and potentially reversible treatment option for patients with metabolic disorders by creating an anastomosis between the stomach and jejunum to bypass the duodenum, with desired metabolic effects. In this way, absorption of stomach contents (e.g., food and other nutrients) in the duodenum can be bypassed, and nutrients from such contents are either not absorbed or are delayed in intake and absorption as such contents move from the stomach through the small intestine, promoting weight loss in patients and potentially controlling or resolving type 2 diabetes.

[0025] Endoscopic procedures such as gastrointestinal anastomosis present various challenges, including the need to endoscopically identify a desired anatomical location (e.g., within the intestine) through tissue barriers, such as those in different anatomical locations (e.g., via the gastric lumen). Ultrasound and / or fluoroscopy procedures provide images through anatomical barriers (e.g., stomach and intestinal walls). However, while ultrasound is useful for imaging tissue, it cannot easily image inorganic materials used to identify tissue. Fluoroscopy is well-suited for viewing dense materials, such as those from which medical devices are made, but contrast agents used with fluoroscopy may dissipate as the target tissue is identified and may need to be reintroduced.

[0026] The use of a locator system at a target location can facilitate identification of the target location from different anatomical locations within a patient's body. Various locator systems include a locator element (e.g., a beacon, such as a light source or other signal generator, or other element identifiable by imaging techniques). The locator element is inserted into a desired location for treatment (e.g., a location in the intestine where connection with the stomach is intended to be made), such as with an endoscope. The endoscope is withdrawn, leaving the locator element in place. The endoscope is then advanced to the imaging site (optionally after being removed from the patient and locator system and then reinserted). One or more instruments for performing the treatment are inserted into and through the endoscope, for example, to make an incision at the imaging site to access the target location (e.g., through the stomach wall and into the peritoneum). It will be understood that terms such as instrument, tool, device, etc. may be used interchangeably herein without any limitation. The locator elements are visualized or otherwise located, such as with the use of an endoscope, to identify a target site for treatment, so that treatment can be performed at the desired target site. For example, once inside the stomach, the physician identifies the desired portion of the small intestine with the aid of the locator elements within the small intestine (as visible from the outside of the intestinal wall). The outside of the small intestine is accessed (e.g., by cutting open the stomach wall and extending a grasper through the peritoneum), grasped, and attached to the stomach. A stent can then be placed to connect the small intestine and stomach, thereby forming an anastomosis.

[0027] Although a locator system can be delivered by an endoscope, in some cases, the endoscope cannot easily reach the target location. For example, a target location in the jejunum for a gastrojejunostomy may be too far for easy access by endoscope. The locator system may be deployed from the distal end of an endoscope using a guidewire. However, delivering a locator system using a guidewire may present various challenges. For example, a certain degree of rigidity may be required to support and / or deliver the locator elements. Additionally or alternatively, the thickness and / or rigidity of the resulting locator system and the delivery system therefor (with the guidewire) may make it difficult to maneuver the locator system through a tortuous body passageway (e.g., through the small intestine).

[0028] The present disclosure describes solutions to the above-mentioned problems of conventional locator devices, systems, and methods. In accordance with various principles of the present disclosure, the locator devices, systems, and methods include locator elements that are deployed independently of a guidewire. In some embodiments, the locator elements are mounted on a housing that can be guided over a separately delivered flexible elongate element (e.g., a guidewire). More specifically, the housing can have a lumen through which the flexible elongate element can be threaded, such that the locator element can be guided over the flexible elongate element to a target location. As described above and as can be understood by those skilled in the art, conventional locator systems include a guidewire to which the locator element is attached. Such a guidewire must be selected to have sufficient stiffness and thickness to adequately support and carry the locator element to a target location. Providing the locator elements on a housing that can be guided over a separate flexible elongate element allows for the use of thinner, more flexible elongate elements than could be used if the locator elements were mounted on and delivered with the flexible elongate element. The thin, flexible elongate element can be easily navigated (using any known or previously known method) to a desired target location, and then the separate locator element can be guided over the flexible elongate element to the target location. In some embodiments, the housing of the locator element is less flexible than the flexible elongate element, such that the locator element can be advanced over the flexible elongate element to facilitate advancement of the locator element over the flexible elongate element. The housing can be an extrusion, such as a flexible tubular element, that can extend over a separately inserted flexible elongate element to guide the housing to the target site. In some embodiments, the proximal end of the housing extends proximally out of the patient, such as to control the advancement of the housing and / or to hold the housing in place at the target site, In some embodiments, the housing does not extend so far that it extends proximally out of the patient.It will be understood that the term housing is used for convenience to refer to a housing or other type of element that can accommodate a locator element (as opposed to a flexible elongated element such as a guidewire) and is not intended to be limited to a particular longitudinal extent.

[0029] In some aspects, the locator elements of a locator system formed in accordance with various principles of the present disclosure have a low profile relative to the system to facilitate delivery to a target location. In some aspects, the position and orientation of the locator elements on a locator system formed in accordance with various principles of the present disclosure allows for increased range for the locator elements to improve visualization and identification of the locator elements by an imaging system at the imaging site.

[0030] It will be understood that locator devices, systems, and methods formed in accordance with various principles of the present disclosure may be used with various devices, systems, and methods for performing procedures within a patient's body other than those disclosed herein. Thus, while the devices, systems, and methods described herein are described with respect to the gastrointestinal system, it will be understood that the devices, systems, and methods according to the present disclosure may be advantageous for use in any other procedures. Furthermore, it will be understood that the devices, systems, and methods described herein may be used in other regions of the anatomy, such as any selective location of tissue through other tissue walls and / or blind spots.

[0031] Various embodiments of locator devices, systems, and methods will now be described with reference to examples illustrated in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more particular features, structures, concepts, and / or characteristics in accordance with the principles of the present disclosure may be included in connection with that embodiment. However, such references do not necessarily imply that all embodiments include the 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 thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment can also be combined with one or more of the features, structures, concepts, and / or characteristics of other embodiments. That is, any of the features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, various features, structures, concepts, and / or properties of the disclosed embodiments may be independent and distinct from one another and may be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of this disclosure. Accordingly, since describing all of the numerous possible combinations and subcombinations of features, structures, concepts, and / or properties would be overly burdensome, the disclosure is not limited to only the embodiments specifically described herein, and the example embodiments disclosed herein are not intended as limiting the broader aspects of the disclosure. Finally, it should be understood that the various dimensions provided herein are examples, and that one of ordinary skill in the art can readily determine appropriate ranges of standard deviations and permissible variations therefrom (e.g., taking into account nominal dimensions, shape, stress / strain considerations, etc.) that are encompassed by the disclosure and any claims associated therewith. The following description is merely an illustrative example of an embodiment and is not intended as limiting the broader aspects of the disclosure.

[0032] It will be understood that common features among the drawings are identified by common reference elements, and for brevity and convenience, and without intent to be limiting, descriptions of common features will generally not be repeated. For clarity, not all components having the same reference number are labeled. In the following description, for brevity, it will be understood that similar elements or components among the various illustrated embodiments having reference numbers greater than 100 will generally be designated by the same reference number incremented by a multiple of 100, and duplicate descriptions will generally be omitted. Furthermore, specific features in one embodiment may be used across different embodiments and will not necessarily be individually labeled when appearing in different embodiments.

[0033] Referring now to the drawings, FIG. 1 illustrates an example of one embodiment of an environment in which a locator system 100 formed in accordance with various principles of the present disclosure may be used. Locator system 100 includes a locator device 110 that is delivered to a desired target site TS using a flexible elongate element 120. Locator device 110 may be any device that can be located by an imaging system or other location system, such as a light source (e.g., an LED), and will be referred to herein for convenience and without limitation as a beacon device 110. In the example illustrated in FIG. 1 , beacon device 110 is delivered to a portion of a patient's jejunum J so as to be juxtaposed with a portion of the patient's stomach S. As can be appreciated, flexible elongate element 120 must navigate a tortuous path through the various bends in the jejunum J.

[0034] According to various principles of the present disclosure, to facilitate navigation of the flexible elongate element 120 to the target site TS, the flexible elongate element 120 is a highly flexible elongate element, such as a flexible guidewire as known to those skilled in the art (e.g., a guidewire that may be used in endoscopic procedures, such as a guidewire having an outer diameter of less than about 0.035 inches / 0.889 mm). Furthermore, according to various principles of the present disclosure, the flexible elongate element 120 is deliverable to the target site TS independently of and prior to delivery of the beacon device 110. The flexible elongate element 120 may be referred to herein as a flexible elongate delivery device 120, such as to emphasize the distinction of such an element being delivered separately from the beacon device 110. Thus, the flexible elongate delivery device 120 can navigate through tortuous paths and bend as necessary without any impedance that may be introduced by providing the beacon device 110 on the flexible elongate delivery device 120 during navigation to the target site TS.

[0035] Further, in accordance with various principles of the present disclosure, the beacon device 110 is attached to a housing 130 configured to be delivered to the target site TS using the flexible, elongate delivery device 120. More specifically, the housing 130 is configured to be delivered over the flexible, elongate delivery device 120. Even more specifically, as can be understood with reference to FIG. 2 , the housing 130 is threaded with a guide lumen 133 configured to slidably receive the flexible, elongate delivery device 120. The guide lumen 133 may extend generally along the longitudinal axis LA of the locator system 100. The flexible, elongate delivery device 120 may be slidably inserted into the guide lumen 133, and the housing 130 may be advanced distally into the patient over the flexible, elongate delivery device 120 until the target site TS is reached. As will be appreciated, the initial placement of flexible elongate delivery device 120 and the separate placement of housing 130 allows for easier manipulation and navigation of locator system 100 than is achieved with conventional systems. Beacon device 110 does not increase the stiffness of flexible elongate delivery device 120 as in conventional systems, and as a result, flexible elongate delivery device 120 can be easily navigated to target site TS. Beacon device 110 is delivered proximal to distal end 121 of flexible elongate delivery device 120. Distal end 121 of flexible elongate delivery device 120 can be delivered sufficiently past target site TS to reduce the risk of beacon device 110 being pushed past distal end 121 of flexible elongate delivery device 120 and becoming dislodged from flexible elongate delivery device 120. If the flexible elongate delivery device 120 is a guidewire, the distal end 121 may be more flexible than the proximal region of the flexible elongate delivery device 120 and may include a radiopaque marker 124 that can guide the advancement of the housing 130 onto the flexible elongate delivery device 120 and into its distal end 121.In some embodiments, the locator system 100 may also include a radiopaque marker 134 located 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 elongate delivery device 120 and the target site TS, such as during delivery of the beacon device 110, such as using fluoroscopy or other imaging system.

[0036] Beacon device 110 may include a beacon housing 112 to which one or more beacon elements 114, 116 are attached. In embodiments in which beacon device 110 is externally powered (e.g., by being coupled via wires to an external power source outside the patient's body), such as those illustrated in Figures 2 and 3, housing 130 also includes a power lumen 135 (e.g., extending generally along longitudinal axis LA of locator system 100) through which a power connection (e.g., electrical wire) for powering beacon device 110 can extend proximally to a power source (e.g., outside the patient's body).

[0037] Additional features of locator system 100 formed in accordance with various principles of the present disclosure may be configured to improve navigation of locator system 100 to target site TS. For example, locator system 100 formed in accordance with various principles of the present disclosure may be configured to minimize the cross-sectional area of ​​the locator system delivery device and / or improve smooth delivery to target site TS, in addition to increasing the flexibility of the locator system delivery device to improve navigation through tortuous body passageways. As can be seen with reference to an example embodiment of locator system 100 shown in FIG. 2 and an example embodiment of housing 130 of locator system 100 shown alone in FIG. 3 , housing 130 includes hollow interior 137 and a window 132 extending through a wall of housing 130 adjacent distal end 131 of housing 130. Window 132 provides lateral access to hollow interior 137 of housing 130 in which beacon device 110 may be positioned. In the illustrated example embodiment, the beacon device 110 is mounted to the housing 130 in a manner that allows visualization of the beacon-generating portion of the beacon device 110 (e.g., an LED) as 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 be mounted generally within the cross-sectional profile of the locator system housing 130 (not extending beyond the cross-sectional profile or periphery of the housing 130), with minimal, if any, impact on the cross-sectional dimensions of the locator system housing 130. Such a configuration allows the overall cross-sectional profile or dimensions of the locator system 100 to be minimized compared to locator systems having beacons mounted on a housing or other delivery device. For example, the beacon device 110 does not protrude more than a few millimeters or a fraction of a millimeter beyond the outer wall of the housing 130 so that the locator system 100 presents an atraumatic exterior and its navigation is not affected by the beacon device 110. In some embodiments, the outer diameter of locator system 100 is selected based on the inner diameter of the working channel of the endoscope through which locator system 100 is delivered.For example, in some embodiments, the outer diameter of locator system 100 is less than about 3.7 mm. In some aspects, a sleeve 140 is provided over window 132 and beacon device 110 to hold beacon device 110 in place relative to window 132 and / or present a smooth, atraumatic surface to tissue at the location of beacon device 110 along locator system 100. Sleeve 140 may be formed from a clear / semi-transparent / translucent / translucent material (e.g., a light-transmitting material) that allows beacon device 110 to be identified therethrough. Additionally or alternatively, sleeve 140 may be formed from a flexible material, such as a heat-shrinkable polymer, such as to facilitate placement of sleeve 140 over beacon device 110 and housing 130.

[0038] In the example modified embodiment of locator system 100 shown in Figure 4, sleeve 140 extends over distal end 131' of housing 130 and / or distal end 131' of housing 130 is itself configured to form a blunt, atraumatic distal end 131' of locator system 100. The remaining elements of locator system 100 shown in Figure 4 are similar to the elements of locator system 100 shown in Figure 2, are labeled with the same reference numerals, and for brevity, reference is made to the above description.

[0039] In accordance with various principles of the present disclosure, beacon devices 110, such as those shown in FIGS. 2 and 4, are positioned to emit signals generally radially relative to locator system 100 and its housing 130, and flexible, elongate, delivery device 120. Such radial emission can facilitate pinpointing the location of locator system 100 and target site TS from the imaging site. In some embodiments, locator systems formed in accordance with various principles of the present disclosure can include two or more beacon elements, such as to increase the ability of the imaging system to locate locator system 100. For example, the housing 130 of locator system 100 shown in FIG. 2 or 3 can include two or more windows 132 to enable two or more beacon devices 110 to emit signals in two or more directions radially relative to locator system 100, housing 130, and / or flexible, elongate, delivery device 120.

[0040] Various above-described principles of the present disclosure may be implemented in other manners. For example, Figures 5, 6, and 7 show another example of an embodiment of a locator system 200 having a beacon device 210 that can be delivered separately from a flexible, elongated delivery device 220. Similar to the locator system 100 described above, the flexible, elongated delivery device 220 of the locator system 200 shown in Figures 5, 6, and 7 can be delivered independently of and prior to the delivery of the beacon device 210. Thus, the flexible, elongated delivery device 220 of the locator system 200 can be thinner than similar components of prior art locator systems that must be able to support a beacon device or element thereon.

[0041] Also, similar to the locator system 100 described above, the locator system 200 shown in Figures 5, 6, and 7 is configured to be delivered separately from, e.g., over, a previously delivered flexible, elongate delivery device 220 of the locator system 200. For example, as seen in Figure 5, the main housing 230 of the locator system 200 may be formed similarly to the housing 130 of the locator system 100 described above and may include at least one guide lumen 233 through which the flexible, elongate delivery device 220 may be threaded. The main housing 230 may be advanced over the previously delivered flexible, elongate delivery device 220 (specifically, with the guide lumen 233 attached to the flexible, elongate delivery device 220) in a manner similar to that described above with respect to the locator system 100. In some embodiments, the main housing 230 is a flexible tubular element. In some embodiments, such flexible tubular element has a proximal end that extends proximally outside the patient, although other lengths of main housing 230 are within the scope and spirit of the present disclosure.

[0042] Also similar to the locator system 200 described above, in accordance with various principles of the present disclosure, the beacon device 210 is mounted relative to the housing 230 in a manner that minimizes the cross-sectional profile of the locator system 200. More specifically, as shown in FIG. 5 , the locator system 200 includes a main housing 230, with the beacon device 210 supported / mounted on a beacon support 250 disposed at a distal end 231 of the main housing 230. The beacon support 250 provides a structure that allows the beacon device 210 to be mounted generally within the cross-sectional profile of the locator system housing 230, with minimal, if any, impact on the cross-sectional dimensions of the locator system housing 230. In an example embodiment shown in FIGS. 5 , 6 , and 7 , the beacon support 250 includes a platform 252 to which the beacon device 210 is mounted, as shown in FIGS. 6 and 7 . Platform 252 extends distally from beacon support 250 and may be positioned to generally remain within (i.e., not protrude beyond) the confines of the cross-sectional profile of main housing 230, with beacon device 210 also remaining within the confines of the cross-sectional profile of main housing 230 as shown in FIG. 7. Platform 252 may optionally have a rounded distal shape to form an atraumatic end that facilitates navigation of main housing 230 to target site TS. As can be seen with reference to FIGS. 5 and 7, beacon support 250 includes a guide passageway 253 that communicates with guide lumen 233 of main housing 230, through which flexible elongate delivery device 220 may pass, whereby locator system 200 (particularly its beacon support 250) is mounted on flexible elongate delivery device 220.

[0043] In some embodiments, platform 252 may facilitate mounting of two or more beacon devices 210 to enable beacon device 210 to emit signals in two or more directions radially relative to locator system 200, as can be understood with reference to, for example, FIG. 7 . For example, beacon device 210 may have beacon housing 212 with beacon elements 214, 216 mounted on each side thereof, as shown in FIGS. 6 and 7 . In some embodiments, beacon elements 214, 216 may be distinct in nature, positioned to emit signals in different (e.g., opposite) directions, or otherwise separately identified. Additionally, beacon support 250 may include a power passageway 255 that allows access to power lumen 235 through main housing 230 for access of power connections, such as wires, to beacon device 210 through main housing 230 and beacon support 250. Platform 252 may be covered by a sleeve 240 (e.g., similar to sleeve 140 described above) to hold beacon device 210 in place relative to beacon support 250. Beacon support 250 and sleeve 240 may be configured to give distal end 201 of locator system 200 a generally blunt, atraumatic shape, as shown in FIG.

[0044] In some embodiments, the beacon support 250 is an end cap formed separately from and attached to the main housing 230. The beacon support 250 may be secured to the distal end 231 of the main housing 230, for example, by bonding (e.g., adhesive, solder, welding, etc.) or mechanical fastening (e.g., interference fit, friction fit, threaded engagement, etc.), or by using a separate structural element such as the sleeve 140 described above or other coupling element such as a heat shrink element. In the illustrated example embodiment, the beacon support 250 includes a collar 254 configured to facilitate fitting of the beacon support 250 onto the distal end 231 of the main housing 230.

[0045] Either or both of the housings 130, 230 of the locator systems 100, 200 described above may be formed as an extrusion, such as a tubular extrusion. The housings 130, 230 may be formed from any of a variety of desired polymers, including, but not limited to, polyethylene, polyether block amide (e.g., Pebax®), polyimide, polypropylene, and other common polymers used in medical device extrusions. The walls of the extrusion may be thin enough (depending on the material) to allow for easy navigation through tortuous anatomical passageways, yet thick and / or stable enough to provide structural stability to the locator systems 100, 200. For example, the walls may be at least about 0.003 inches (0.0762 mm) thick. The housings 130, 230 may be extruded, with their respective lumens 133, 135, 233, 235 formed by the extrusion process. The proximal ends of lumens 133, 135, 233, 235 are advantageously open to facilitate access thereto, although it will be understood that the distal ends of lumens 133, 135, 233, 235 may be closed in any of a variety of ways known to those skilled in the art.

[0046] The beacon devices 110, 210 of the above-described locator systems 100, 200 can be any desired device or element capable of being identified and located by an imaging system known or previously known to those skilled in the art. For example, the beacon devices 110, 210 can include one or more LEDs, such as an array of LEDs as described in U.S. Patent Application Publication No. 2021 / 0196106, entitled "Devices, Systems, And Methods For Locating A Body Lumen," published July 1, 2021. For example, in some embodiments, the LEDs are of different wavelengths (e.g., colors) to facilitate imaging, e.g., from different distances and / or with different imaging equipment. Additionally or alternatively, the beacon devices 110, 210 can be another type of signal-emitting or visualization device or element known or previously known to those skilled in the art, and the disclosure is not limited in this respect.

[0047] It will be understood that, other than certain differences between the locator systems 100, 200 shown in Figures 1-7, the locator systems 100, 200 may operate / be used in substantially the same or similar manner. Accordingly, common features are identified by common reference elements, and for the sake of brevity, descriptions of common features will not be repeated. For clarity, not all components have been labeled with the same reference numbers.

[0048] In use, the flexible, elongate delivery device 120, 220 of the locator system 100, 200 formed according to various principles of the present disclosure is advanced so that its distal end 121, 221 is positioned at a target site TS within a patient. Typically, although not necessarily, the locator system 100, 200 is delivered through a working channel 163 of an endoscope 160, such as that shown in FIG. 1 . In one exemplary embodiment of the environment shown in FIG. 1 , the endoscope 160 is advanced through the patient's mouth, esophagus, and stomach (and optionally, past the pylorus and into the duodenum). Because not all endoscopes are long enough to extend to all target sites, the flexible, elongate delivery device 120, 220 extends distally out of and beyond the distal end 161 of the endoscope 160 to the target site. 1 , the distal end 161 of the endoscope 160 extends through the stomach S, past the pylorus P, and into the duodenum D, but may not extend very far past the pylorus P. The flexible elongate 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 elongate delivery device 120, 220 is advanced to and positioned at the target site TS, the flexible elongate delivery device 120, 220 is held in place relative to the patient (e.g., by holding the proximal end of the flexible elongate delivery device 120, 220 in place, by any method known to those skilled in the art, such as by securing the proximal end to the patient or a stationary device near the patient). The housing 130, 230 with the beacon device 110, 210 (and associated components) can then be advanced over the flexible, elongate 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 through which the locator system 100, 200 will be delivered, such as to be less than the inner diameter of a typical endoscope (e.g., about 3.7 mm).The inner diameter of the power lumen 135, 235 (in which at least a portion of the beacon device 110, 210 may be disposed) may 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 may be selected based on the outer diameter of the flexible, elongate delivery device 120, 220 that will be slidably inserted therethrough. For example, the inner diameter of the guide lumen 133, 233 may be approximately 0.027 inches ± 0.01 inches (0.686 mm ± 0.2 mm). The housing 130, 230 is guided over the flexible, elongate delivery device 120, 220 and similarly advanced to the target site TS. The length of the housing 130, 230 may be selected to facilitate navigation through tortuous bodily passageways. 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 locator system 100, 200 can be held in place relative to the target site TS and the flexible elongate delivery device 120, 220 can be withdrawn. For example, if the proximal end of the housing 130, 230 extends proximally out of the patient's body, such proximal end can be secured relative to the patient or otherwise (e.g., in a manner similar to how the flexible elongate delivery device 120, 220 was initially held in place) to maintain the position of the beacon device 110, 210 relative to the target site TS. The endoscope used to deliver the locator system 100, 200 can be withdrawn and then, optionally, used to deliver an imaging system to another location within the patient to identify the locator system 100, 200. The beacon devices 110, 210 are activated (or have already been activated if activation is necessary) so that the locator systems 100, 200 can be identified from another location inside or outside the patient's body. An imaging system capable of identifying / locating the locator systems 100, 200 is then advanced to an anatomical location different from the target site TS to identify / locate the locator systems 100, 200 (e.g., their beacon devices 110, 120) at the target site TS.The endoscope 160 may be withdrawn, and then an instrument, tool, device, etc. (such terms are used interchangeably herein and are not intended to be limiting) may be advanced through the working channel 163 of the endoscope 160. Further steps may then be performed depending on the planned treatment / procedure to be performed at the target site TS. The endoscope 160 may be completely withdrawn from the flexible elongate delivery device 120, 220, such that the working channel 163 of the endoscope 160 clears a passage for other devices therein. In some embodiments, the locator system 100, 200 may be anchored relative to the target site TS, and the flexible elongate delivery device 120, 220 may be withdrawn, such that the endoscope 160 does not need to be withdrawn from the flexible elongate delivery device 120, 220. The endoscope 160 may include a visualization device capable of visualizing the locator system 100, 200, and / or additional imaging equipment may be used to identify the locator system 100, 200. For example, endoscope 160 may be positioned within stomach S to identify a target site TS within jejunum J so that an anastomosis may be formed between stomach S and jejunum J (e.g., to perform a gastric bypass). It will be understood that any component of locator system 100, 200 and / or endoscope 160 may be controlled at its proximal end by a medical professional in a manner known to those skilled in the art.

[0049] While embodiments of the present disclosure may be described with particular reference to medical devices, systems, and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may be used to identify and treat tissue in the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. While embodiments of the present disclosure may be described with particular reference to medical devices and systems (e.g., endoscopic devices, accessory tools, and / or guidewires) used in the GI system, it should be understood that locator devices and systems as described herein may be used in a variety of medical procedures performed in ducts, lumens, vessels, or body luminal anatomies, including, for example, interventional radiology procedures, balloon angioplasty / angiography procedures, thrombolysis procedures, urological or gynecological procedures, etc. Medical devices herein may include various medical devices for navigating body lumens, including, for example, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. The disclosed medical devices and systems can also be inserted through different access points and approaches, for example, percutaneously, endoscopically, laparoscopically, or combinations thereof.

[0050] In view of the above, it should be understood that the various embodiments shown in the figures each have several distinct and independent features that, at least alone, have inherent advantages that are desirable, but not essential, to the locator devices, systems, and methods of the present disclosure. Thus, the various distinct features described herein need not all be present to achieve at least some of the desired properties and / or advantages described herein. Only one of the various features may be present in a locator device, system, or method formed in accordance with various principles of the present disclosure. Alternatively, one or more of the features described with reference to one embodiment may be combined with one or more of the features of any of the other embodiments provided herein. That is, any of the features described herein may be mixed or matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Furthermore, throughout this disclosure, reference numbers are used to indicate general elements or features of the embodiments of the present disclosure. The same reference numbers may be used to indicate elements or features that are not identical in form, shape, structure, etc., but that provide similar functions or advantages. Additional reference numerals (such as letters, as opposed to numbers) may be used to distinguish similar elements or features from one another.

[0051] Those skilled in the art will appreciate that this discussion is a description of illustrative examples of embodiments only and is not intended to limit the broader aspects of the present disclosure. All devices and methods discussed herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only ways of implementing these principles; they 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 drawings should be understood as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the specific elements, structures, or features shown. Those skilled in the art will, upon reading this disclosure, be able to think of other examples of ways to implement the disclosed principles. It will be apparent to those skilled in the art that variations can be applied to the disclosed devices, systems, and / or methods and / or to the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be understood that various features described with respect to one embodiment may typically be applied to other embodiments, whether explicitly shown or not. The various features described below may be used alone or in any combination thereof. Accordingly, it is not intended that the present invention be limited to only the embodiments specifically described herein, but that all substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the present disclosure as defined by the appended claims.

[0052] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the disclosure to the form or 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 concept, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the disclosure have been grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of particular aspects, embodiments, or configurations of the disclosure can be combined into alternative aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be understood that various individual features of the subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the subject matter or such individual features. Those skilled in the art will recognize that the present disclosure can be used with many modifications specifically adapted to particular environments and operating requirements, or with modifications to the structure, arrangement, proportions, materials, components, and other aspects used in practicing the disclosure, without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed can be composed of multiple pieces, or elements shown as multiple pieces can be formed integrally, operations of elements can be reversed or otherwise changed, and elements can be sized or dimensioned differently. Similarly, although operations, actions, or steps are described in a particular order, this should not be understood as indicating that such a particular order is required, or that all operations, actions, or steps should be performed, to achieve desirable results. Moreover, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims and not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the above, it is to be understood that individual features of any embodiment can be used and claimed separately or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0053] In the foregoing description and in the claims that follow, it will be understood that the terms "at least one," "one or more," and "and / or," as used herein, are open-ended expressions that operate both conjunctively and disjunctively. The terms "a," "an," "the," "first," "second," etc., do not exclude a plurality. For example, the terms "a" or "an" entity, as used herein, refer to one or more of that entity. Thus, the terms "a" (or "an"), "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 sense to include "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so connected, alone as well as in any combination and number, unless the context clearly dictates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid the reader in understanding this disclosure and / or serve to distinguish regions of associated elements from one another and do not limit the associated elements, particularly with respect to position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, and joined) should be interpreted broadly and, unless otherwise indicated, encompass direct and indirect connections, and may also include intermediate members between sets of elements, and relative movement between the elements. Thus, connection references do not necessarily imply that two elements are directly connected and in fixed relationship to each other.Distinguishing references (e.g., primary, secondary, first, second, tertiary, quaternary, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0054] The following claims are incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises," "comprising," "includes," and "including" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. In addition, although individual features may be included in different claims, these may sometimes be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. Furthermore, reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. a housing having a guide lumen extending therethrough and configured to advance the housing over a flexible, elongate delivery device to a target site within a patient's body; a beacon element associated with the housing and configured to be imaged by an imaging system remote from the target site; A locator system comprising:

2. the housing has a wall defining a hollow interior within the housing; a window defined through a wall of the housing; the beacon element is positioned within the housing so as to be identified through the window; The locator system of claim 1 .

3. The locator system of claim 2 , wherein the beacon elements emit signals through the windows radially outwardly toward the locator system.

4. 4. The locator system of claim 2 or 3, further comprising a sleeve around the beacon element and the window to hold the beacon element within the housing, the sleeve enabling imaging of the beacon element through the sleeve.

5. The locator system of any one of claims 2 to 4, wherein a power lumen extends through the housing configured for passage of a power connection through the housing from a power source to the beacon element.

6. The locator system of claim 1 further comprising a beacon support attached to a distal end of said housing, said beacon elements being attached to said beacon support.

7. The locator system of claim 6 , wherein the beacon elements are mounted on the beacon support so as to be imageable from two or more directions radially relative to the locator system.

8. 8. The locator system of claim 6 or 7, wherein the beacon support comprises a platform to which the beacon elements are mounted.

9. The locator system of any preceding claim, wherein the housing has a cross-sectional area and the beacon is disposed within the cross-sectional area of ​​the housing.

10. The locator system of any one of claims 1 to 9, wherein the housing is formed as an extrusion.

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

12. a housing having a guide lumen extending therethrough; a beacon element associated with the housing and configured to be identified by an imaging system remote from a target site; a flexible elongate delivery device; the flexible, elongate delivery device is slidably insertable into the guide lumen, and the housing is slidable over the flexible, elongate delivery device so that the housing can be advanced to a target site within a patient's body independently of the flexible, elongate delivery device; Locator system.

13. the housing has a wall defining a hollow interior within the housing; a window defined through a wall of the housing; the beacon element is positioned within the housing so as to be imaged through the window; The locator system of claim 12.

14. The locator system of claim 12 further comprising a beacon support attached to a distal end of said housing, said beacon elements being attached to said beacon support.

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

Images