Expandable devices and systems for navigating tortuous body access and associated methods

Abstract

Devices and systems for facilitating navigation through a body pathway, in particular a tortuous body pathway. The expandable member (130) is mounted in relation to an element of the device or system and is transitionable from a delivery configuration to an expanded configuration. In the expanded configuration, the expandable member facilitates navigating the device and / or system through a tortuous section of the body pathway. The expandable member may include an expandable basket element formed of one or more elements that is transitionable from a generally elongated configuration when the expandable member is in the delivery configuration to a curvilinear or arcuate configuration when the expandable member is in the expanded configuration. Additionally or alternatively, the expandable member may include an inflatable balloon. The systems and methods may include a delivery device (120) and a locator element (110) to identify a target site from a remote location.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 416,172, filed Oct. 14, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0002] The present invention generally relates to devices, systems, and methods for performing surgery in vivo, such as endoscopic surgery. More particularly, the present invention generally relates to devices, systems, and methods for navigating to an anatomical site within a patient, such as at a site where surgery is to be performed. Even more particularly, the present invention relates to devices, systems, and methods for facilitating the navigation, delivery, and deployment of a device or system through tortuous body passages to a target site. Background Art

[0003] A variety of medical procedures require navigating instruments, devices, tools, etc. through tortuous body passages, such as the small intestine. Medical professionals may face challenges in navigating even highly flexible delivery devices, such as guidewires, through such tortuous body passages. Due to the tortuosity of the small intestine and differences between patient anatomies, the pushability and trackability of a guidewire through the small intestine pose significant challenges. In addition, a flexible guidewire may form loops (e.g., coil itself into a loop) within a tortuous body passage or certain anatomical structures. If a flexible elongate element cannot be advanced to a target site (e.g., a treatment site) to deliver a device to the target site, further surgery cannot be performed. With regard to these and other considerations, improvements to the present invention may be useful. Summary of the Invention

[0004] This Summary of the Invention is provided to introduce a series of concepts in a simplified form that will be further described in the Detailed Description below. This Summary of the Invention is not necessarily intended to identify 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 aspects and features of the present invention may, in some instances, be advantageously used alone or, in other instances, in combination with other aspects and features of the present invention, whether or not they are described in this Summary of the Invention. Inclusion or exclusion of an element, component, etc. in this Summary of the Invention is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of the present invention, a system for navigating within a patient's anatomy to a target site within the patient includes: a flexible elongate delivery device having a distal end that can be navigated within the patient and a proximal end that can be accessed to navigate the flexible elongate delivery device; a device carried by the flexible elongate delivery device along its distal end for deployment at the target site; and an expandable member associated with the flexible elongate delivery device and configurable to transition between a delivery configuration and an expanded configuration, the expanded configuration having a cross-sectional dimension greater than that of the delivery configuration. The expandable member can be mounted adjacent to the device carried by the flexible elongate delivery device.

[0006] In some embodiments, the expandable member includes one or more flexible elongate elements configurable to transition from a generally elongated delivery configuration to an expanded configuration. In some embodiments, the one or more flexible elongate elements are bowed or curved when in the expanded configuration. In some embodiments, the one or more flexible elongate elements are formed of a shape memory material configured to transition the expandable member to the expanded configuration when a force is applied thereto and to return the expandable member to the delivery configuration when the force is removed therefrom. In some embodiments, the flexible elongate delivery device includes a flexible tubular element and an actuator extending through the flexible tubular element, the actuator being coupled to the expandable member to transition the expandable member between the delivery configuration and the expanded configuration upon axial translation of the actuator. In some embodiments, the proximal end of the one or more flexible elongate elements is coupled to the distal end of the flexible elongate element, and the distal end of the one or more flexible elongate elements is coupled to the actuator. In some embodiments, retracting the actuator proximally causes the one or more flexible elongate elements to expand the expandable member into the expanded configuration.

[0007] In some embodiments, the expandable member includes an inflatable balloon. In some embodiments, the system further includes an inflation lumen extending along the flexible elongate delivery device and in fluid communication with the inflatable balloon to deliver an inflation medium thereto to transition the inflatable balloon from the delivery configuration to the expanded configuration.

[0008] In some embodiments, the expandable member is mounted adjacent to the distal end of the flexible elongate delivery device, and the system further includes a locator element mounted along or adjacent to the distal end of the flexible elongate delivery device.

[0009] In some embodiments, the expandable member is expandable to have a diameter that is at least half of the inner diameter of the body passageway through which the system is to be navigated.

[0010] In accordance with various principles of the present invention, a system for navigating within a patient's anatomy to a target site within the patient includes an endoscope having a working channel extending therethrough; a flexible elongate delivery device having a distal end that can extend distally from the working channel of the endoscope and can be navigated within the patient, and a proximal end that can be accessed to navigate the flexible elongate delivery device; a device carried by the flexible elongate delivery device along its distal end for deployment at the target site; and an expandable member mounted relative to the flexible elongate delivery device and configurable between a delivery configuration and an expanded configuration, the expanded configuration having a cross-sectional dimension greater than that of the delivery configuration. The expandable member can be mounted adjacent to the device carried by the flexible elongate delivery device.

[0011] In some embodiments, the expandable member includes one or more flexible elongate elements configurable from a generally elongated delivery configuration to an expanded configuration.

[0012] In some embodiments, the expandable member is an inflatable balloon.

[0013] In some embodiments, the expandable member is mounted adjacent to the distal end of the flexible elongate delivery device, and the system further includes a locator element mounted along or adjacent to the distal end of the flexible elongate delivery device. In some embodiments, the system further includes a locator element mounted along or adjacent to the distal end of the flexible elongate delivery device.

[0014] In accordance with various principles of the present invention, a method of navigating a device within a patient includes: advancing a flexible elongate delivery device into a body passageway within the patient; and when advancing the distal end of the flexible elongate delivery device into a tortuous section of the body passageway, expanding an expandable member mounted adjacent to the distal end of the flexible elongate delivery device from a delivery configuration to an expanded configuration to facilitate navigating the distal end of the flexible elongate delivery device past the tortuous section of the body passageway.

[0015] In some aspects, the method further includes expanding the expandable member to have an outer diameter that is at least half of the inner diameter of the tortuous section of the body passageway to prevent the flexible elongate delivery device from kinking back on itself within the tortuous section of the body passageway.

[0016] In some aspects, the method further includes expanding the expandable member to expand the tortuous section of the body passageway.

[0017] In some aspects, the method further includes advancing the expandable member past the tortuous section of the body passageway and returning the expandable member to the delivery configuration.

[0018] In some aspects, the method further includes delivering a locator element mounted adjacent to the distal end of the flexible elongate delivery device to a target site within the patient.

[0019] These and other features and advantages of the present invention will become 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 individual aspects may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention is described by way of example with reference to schematic and not-to-scale drawings that illustrate non-limiting embodiments of the invention. The drawings are provided for illustrative purposes only, and the dimensions, positions, sequences, and relative sizes reflected in the figures of the drawings may vary. For example, a device may be enlarged so that details are discernible, but is intended to be reduced with respect to, for example, fitting within the working channel of a delivery catheter or endoscope. In the drawings, the same or almost the same or equivalent elements are generally denoted by the same reference characters, and similar elements are generally named with similar reference numbers incremented by 100, with redundant descriptions omitted. For clarity and simplicity, not every element is labeled in every figure, and not every element of each embodiment shown is necessary for one of ordinary skill in the art to understand the present invention.

[0021] The detailed description will be better understood in conjunction with the drawings, in which like reference characters denote like elements, as described below:

[0022] Figure 1 A perspective view of an example of an embodiment of a locator system formed in accordance with aspects of the present invention that is shown schematically being navigated through a gastrointestinal environment.

[0023] Figure 2A A perspective view of an example of an embodiment of an expandable system formed in accordance with various principles of the present invention and in a collapsed configuration.

[0024] Figure 2B Shown such as Figure 2A A perspective view of the expandable system shown in and in a partially expanded configuration.

[0025] Figure 2C Shown such as Figure 2A A perspective view of the expandable system shown in and in an expanded configuration.

[0026] Figure 3A Another example of an embodiment of an expandable system formed in accordance with various principles of the present invention and in a collapsed configuration.

[0027] Figure 3B Shown such as Figure 3APerspective view of an expandable system shown in [description] but in an expanded configuration.

[0028] Figure 3C Shows such as Figure 3A and Figure 3B Perspective view of an expandable system shown in [description] but advanced beyond a tortuous body passageway.

[0029] Figure 4A Shows another example of an embodiment of an expandable system formed according to various principles of the present invention and in a collapsed configuration.

[0030] Figure 4B Shows such as Figure 4A Another example of an embodiment of an expandable system shown in [description] but in an expanded configuration. Detailed Description

[0031] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the present invention is not limited to the specific embodiments described and may therefore vary. All devices and systems and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present invention. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles, but merely an example. Therefore, reference to an element or structure or feature in the drawings must be understood as a reference to an example of an embodiment of the present invention and should not be construed as limiting the present invention to the specific element, structure, or feature shown. Other examples of ways to implement the disclosed principles will occur to those of ordinary skill in the art upon reading the present invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the subject matter. For example, features illustrated and described as part of one embodiment can be used with another embodiment to produce a further embodiment. Therefore, the subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0032] It should be understood that the present invention is set forth in various levels of detail in this application. In some instances, details that are unnecessary for those of ordinary skill in the art to understand the present invention or that would obscure other details may have been omitted. The terms used herein are only for describing specific embodiments and are not intended to limit beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein are to be understood as would be commonly understood by one of ordinary skill in the art to which the present invention pertains. According to the present invention, all devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation.

[0033] As used herein, "proximal" refers to closest to the user (such as a medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein and not intended to be limiting, and including an automated controller system or the like), such as when using the device (e.g., introducing the device into a patient's body, or during implantation, positioning, or delivery) and / or the direction or position closest to the delivery device, and "distal" refers to farthest from the user, such as when using the device (e.g., introducing the device into a patient's body, or during implantation, positioning, or delivery) and / or the direction or position closest to the delivery 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 remain in a fixed configuration if the element buckles or bends, and "axial" generally refers to along the longitudinal axis. However, it should be understood that references to axial or longitudinal movement relative to the above-described system or its elements need not be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Central" means at least generally bisecting a central point and / or being generally equidistant from a perimeter or boundary, and a "central axis" means a line that at least generally bisects the central point of an opening, which extends longitudinally along the length of the opening when the opening includes, for example, a tubular element, a channel, a cavity, or a hole. As used herein, a "lumen" or "channel" or "hole" or "passageway" is not limited to a circular cross-section. As used herein, a "free end" of an element is the terminal beyond which the element does not extend. It should be understood that, unless otherwise specified, terms such as at, on, near, or along an end may be used interchangeably herein and are not intended to be limiting, unless otherwise specified, and are intended to denote a generally relative spatial relationship rather than a precisely limited position. Finally, reference to "at" a location or site is intended to include at and / or near such location or site (e.g., along it, adjacent to it, etc.).

[0034] In order to perform various medical procedures non-invasively (e.g., trans-lumenally, without open surgery), it is necessary to navigate instruments, tools, devices, etc. (such terms being used interchangeably herein and not intended to be limiting) through tortuous body passageways. For example, various procedures can be performed trans-lumenally through or within the intestine. One procedure performed relative to the small intestine is gastrojejunostomy, which involves creating an anastomosis between a patient's stomach and a portion of the patient's jejunum. The anastomosis is formed from within the stomach along the jejunum to a target site. In order to locate the target site along the jejunum, a locator system can be delivered through the small intestine to the target site in the jejunum. In some embodiments, the locator system includes a beacon element delivered on a flexible elongate element, such as a flexible elongate delivery device, which has sufficient flexibility to be navigated through the jejunum to deliver the beacon element to the target site.

[0035] In accordance with various principles of the present invention, an expandable element is provided on a flexible elongate delivery device to facilitate navigating the delivery device through an anatomical structure to a target site. It should be understood that terms such as navigate, operate, manipulate, control, direct, advance, etc. and their other grammatical forms may be used interchangeably herein and are not intended to be limiting. In some embodiments, the expandable element is an expandable basket element formed by one or more elements that can transition between a delivery configuration and an expanded configuration or cause an expandable member to transition between a delivery configuration and an expanded configuration. In some embodiments, the expandable element is an expandable balloon. Optionally, the expandable member includes both an expandable basket and an expandable balloon. The expandable element can expand to at least half the inner diameter of a body passageway through which a locator system is navigated such that the locator system cannot reverse itself. It should be understood that terms or descriptions such as reverse, form a loop, bend, etc. may be used interchangeably herein to refer to configurations that interfere with the advancement of the system through the body passageway and are not intended to be limiting. The expandable element can be expanded to expand the body passageway and reconfigure the body passageway such that the locator system can be more easily advanced through the body passageway. In some embodiments, the expandable element can be used to anchor the locator system in place at a treatment site. In some embodiments, the flexible elongate delivery device is configured to indicate from outside the patient the distance by which its distal end has been advanced, such as to verify that the distal end has reached a desired target site. For example, markings can be provided along or on the proximal end of the flexible elongate delivery device to indicate the extent to which the elongate flexible delivery device has been advanced. If the target site is located at a specific distance within the patient, sufficient advancement of the system can be determined from outside the patient. In some embodiments, the flexible elongate delivery device and / or the expandable element includes markings, such as radiopaque markings, for visualizing the position of the expandable element within the patient, such as via fluoroscopy or other acceptable imaging techniques.

[0036] Various embodiments of devices, systems, and methods having expandable elements facilitating navigation through tortuous body passages will now be described with reference to the examples shown in the accompanying drawings. References in this specification to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc., indicate that one or more particular features, structures, concepts, and / or characteristics according to the principles of the present invention may be included with that embodiment. However, such references do not necessarily mean that all embodiments include the particular features, structures, concepts, and / or characteristics, or that one embodiment includes all of the features, structures, concepts, and / or characteristics. Some embodiments may include one or more of 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 may be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein may be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present invention. Additionally, references to "one embodiment", "an embodiment", "some embodiments", "other embodiments", etc., throughout the specification do not necessarily refer to the same embodiment, nor are they necessarily separate or alternative embodiments mutually exclusive of other embodiments. It should also be understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and separable from one another and may be used or presented individually or in various combinations with one another to create alternative embodiments considered to be part of the present invention. Thus, the present invention is not limited to the embodiments specifically described herein, as listing all possible combinations and sub - combinations of the described features, structures, concepts, and / or characteristics would be overly burdensome, and the examples of the disclosed embodiments are not intended to limit the broader aspects of the present invention. It should be understood that the various dimensions provided herein are examples, and one of ordinary skill in the art can readily determine the appropriate ranges of standard deviations and acceptable variations covered by the present invention and any claims associated therewith. The following description is only an illustrative example of the embodiments and is not intended to limit the broader aspects of the present invention.

[0037] It should be understood that common features are identified by common reference elements, and for the sake of brevity and convenience and not by way of limitation, the description of common features is generally not repeated. For clarity, not all components with the same reference numeral will be numbered. In addition, a group of similar elements may be indicated by numbers and letters, and generally only a single element or such an element or such elements as a group (excluding the letters associated with each similar element) may be referred to by a number alone. It should be understood that in the following description, similar elements or components in various illustrated embodiments with reference numerals greater than 100 are generally denoted by the same reference numeral increased by a multiple of 100, and for the sake of brevity, redundant descriptions are generally omitted. In addition, certain features in one embodiment may be used across different embodiments and do not require separate marking when appearing in different embodiments.

[0038] Turning now to the drawings, Figure 1 an example of an embodiment of a system 100 that can be used to deliver a device to a target site TS is shown. In accordance with various principles of the present invention, Figure 1 the system 100 shown includes a flexible elongate delivery device 120 that carries a device 110. For convenience and not by way of limitation, reference is made to the locator element 110 and not just the device. However, it should be understood that although the illustrated example of an embodiment of the system 100 is configured to deliver the locator element 110, other devices of the system 100 formed in accordance with various principles of the present invention, as well as other configurations, uses, etc., are also within the scope and spirit of the present invention. In addition, although the system 100 is shown in a gastrointestinal environment, the principles of the present invention are also applicable to other anatomical sites.

[0039] As Figure 1Further shown in, according to various principles of the present invention, the expandable member 130 is positioned adjacent to the distal end 121 of the flexible elongate delivery device 120. The expandable member 130 can be carried adjacent to the distal end 121 of the flexible elongate delivery device 120, distally, proximally, or coextensively with the locator element 110, as described in further detail below. The expandable member 130 can be selectively expanded from a contracted or collapsed delivery configuration to an expanded configuration having a cross-sectional dimension greater than that in the delivery configuration. In the delivery configuration, the expandable member 130 can be delivered through a lumen (e.g., with an endoscope or other tubular delivery element, such as a delivery catheter or sheath and / or through a body passageway). In certain passageways, such as tortuous body passageways, expanding the expandable member 130 into the expanded configuration facilitates advancing the system 100 therethrough. For example, expanding the expandable member 130 to a diameter at least half of the inner diameter of the body passageway through which the system 100 is being advanced can prevent the expandable member 130 from forming loops and thus facilitate distal advancement of the system 100 through the body passageway. Additionally or alternatively, expansion of the expandable member 130 can straighten or otherwise condition the morphology of the tortuous body passageway to facilitate advancement therethrough. Once the system 100 can be further advanced as needed (such as, but not necessarily while still in the expanded configuration), the system 100 can be further advanced in the delivery configuration. In some embodiments, once located at the target site TS, the system 100 can return to the expanded configuration for various purposes, as described in the examples shown below with reference to embodiments of systems formed according to various principles of the present invention.

[0040] Figure 1 An example of an embodiment of the system 100 shown in Figure 2A , Figure 2B and Figure 2C is shown in further detail therein, which shows various configurations of the expandable member 130. The expandable member 130 is shown in Figure 2A as extending generally along the distal end 101 of the system 100 in a collapsed configuration. As can be appreciated with reference to Figure 2B and Figure 2C , an example of a flexible elongate delivery device 120 of an embodiment of the system 100 includes a flexible tubular element 122 and an actuator 124. The actuator 124 can be a core wire, a pull wire, a guide wire, or other flexible elongate element capable of axially translating within the flexible tubular element 122. As can be appreciated with reference to Figure 2A , Figure 2B and Figure 2C , the expandable member 130 extends distally from the distal end 121 of the flexible tubular element 122 of the flexible elongate delivery device 120. And, as can be appreciated with reference to Figure 2B and Figure 2CAs understood, the actuator 124 extends through the flexible tubular element 122 and extends along (e.g., through) the expandable member 130 to the distal end 131 of the expandable member 130. The distal end 123 of the actuator 124 is coupled to the distal end 131 of the expandable member 130. In some embodiments, an end cap 132 (e.g., a cylindrical collar or loop that is open at both ends or only at one end) is disposed (mounted, coupled to, etc.) at the distal end 131 of the expandable member 130, such as to receive the distal end 131 of the expandable member 130. In some embodiments, the distal end 123 of the actuator 124 is coupled to an end cap 132 that supplements or replaces the distal end 131 of the expandable member 130. The end cap 132 may be coupled to the distal end 131 of the expandable member 130 and / or the actuator 124, and the proximal end 133 of the expandable member 130 may be coupled to the distal end 121 of the flexible tubular element 122 in any of a variety of ways known to those of ordinary skill in the art, such as by adhesion (e.g., adhesive bonding, welding, brazing, soldering, etc.), mechanical interference (e.g., crimping, friction fitting, etc.), mechanical coupling (e.g., riveting, threaded engagement, etc.), etc. The proximal end of the flexible elongate delivery device 120, and more particularly the proximal ends of the flexible tubular element 122 and the actuator 124 (not shown, but readily understood by those of ordinary skill in the art as to their configuration) extend proximally to a location that permits a medical professional to control their position. A control handle may be provided, such as any control handle known to those of ordinary skill in the art, or the proximal end may be directly grasped and manipulated by a medical professional. In some embodiments, the control handle includes an actuator or trigger or other mechanism known to those of ordinary skill in the art that is configured to permit a medical professional to actuate the actuator 124 to control the transformation of the shape of the expandable member 130.

[0041] According to various principles of the present invention, Figure 2A 、 Figure 2B and Figure 2C a proximal retraction of the actuator 124 of the example of embodiment 100 of the system shown in Figure 2A causes the distal end 131 of the illustrated example of the expandable member 130 to move closer to the proximal end 133 of the expandable member 130 and results in the expansion of the expandable member 130. Such actuation can be achieved in a variety of ways known to those of ordinary skill in the art. For example, the illustrated example of the expandable member 130 is formed from one or more flexible elongate elements 134, such as wires, ribbons, bands, filaments, etc. The flexible elongate elements 134 are formed from a material that permits the flexible elongate elements 134 to bend outwardly, bow, or curve to expand the cross-sectional dimension of the expandable member 130 (transverse to the longitudinal axis LA of the system 100), such that the expandable member 130 transitions from Figure 2A the generally elongate delivery configuration shown in Figure 2B to the transitional configuration shown in Figure 2CThe dilation configuration shown, such as with the assistance of actuator 124. Thus, when in the Figure 2A delivery configuration shown, the system 100 can be advanced through a body passageway. When the system 100 approaches or is advanced to a particularly tortuous section of the body passageway (e.g., a bend or kink in the small intestine), the expandable member 130 can be expanded to facilitate advancing the system 100 through the body passageway. For example, if the expandable member 130 expands to at least half the inner diameter of the body passageway, the system 100 cannot fold back on itself because it is too wide to fit within the body passageway. Additionally or alternatively, the expansion of the expandable member 130 can cause the body passageway to expand and reconfigure (e.g., straighten, elongate, etc.) to facilitate passage of the expandable member 130 and the system 100 therethrough. Additionally or alternatively, the expansion of the expandable member 130 helps expand the body passageway in which the expandable member 130 is positioned and / or move tissue aside to facilitate easier delivery. For example, when positioned in a patient's intestine, the expandable member 130 can open the intestine that would otherwise collapse (because prior to the procedure being performed, the patient is typically not allowed to eat and thus there is no food in the intestine to keep the walls of the intestine open). Once the system 100 is able to navigate through the tortuous body passageway, the expandable member 130 can return to its delivery configuration, such as Figure 2C shown, or alternatively return to a configuration between the delivery configuration and the dilation configuration. The system 100 can then be advanced to the target site TS, and the expandable member 130 can be delivered to the target site TS, such as Figure 1 shown.

[0042] As described above, the expandable member 130 can be expanded to facilitate navigation through a particular anatomy, such as a tortuous body passageway, and then return to an unexpanded delivery configuration once past such a particular anatomy. To facilitate returning the expandable member 130 to the delivery configuration, one or more elements of the expandable member 130 can be formed from a shape memory material that causes the expandable member 130 to return to its delivery configuration. The shape memory material can be selected from one or more (preferably biocompatible) metals (e.g., stainless steel, nitinol, etc.), polymers, or combinations thereof. In such an embodiment, the expandable member 130 transitions to the dilation configuration when a force is applied thereto, and the expandable member 130 returns to the delivery configuration when the force is removed.

[0043] In Figure 1 、 Figure 2A 、 Figure 2B and Figure 2C the example of the system 100 embodiments shown, the flexible elongate delivery device 120 delivers the device 110 to the target site TS. As described above and as can be referencedFigure 2B and Figure 2C As understood, the device 110 may include locator elements 110. Although the locator elements 110 are shown as being positioned generally along the expandable member 130, it should be understood that other relative positions of these elements are within the scope and spirit of the present invention. For example, the locator elements 110 may be proximal or distal to the expandable member 130 without impairing aspects or the structure or function of the system 100. In Figure 2B and Figure 2C the example of the illustrated embodiment, the locator elements 110 are mounted on the actuator 124 and are generally within the expandable member 130. It should be understood that other configurations and positions of the device 110 are within the scope and spirit of the present invention. For example, the material of the expandable member 130 and / or the markers (e.g., radiopaque markers) may be imaged by various imaging systems and may thus serve as a device for delivering by the system 100 to locate a target site TS within a body passageway from a remote different location (outside or inside the patient). For example, the expandable member 130 may be formed of a material capable of being imaged, such as metal. Thus, the expandable member 130 may also serve as a locator element 110, which may be used to identify the target site TS at which the expandable member 130 has been deployed. Optionally, one or more additional locator elements 112, such as radiopaque markers, may be provided on the expandable member 130, such as on one or more or each of the flexible elongate elements 134. For example, a plurality of additional locator elements 112 may be provided along the longitudinal extent of at least one of the flexible elongate elements 134, such as Figure 2A and Figure 2B as shown in

[0044] The expandable members of systems formed in accordance with various principles of the present invention may be formed in any of a variety of ways other than Figure 2A , Figure 2B and Figure 2C the example of the illustrated embodiment. For example, in Figure 3A , Figure 3B and Figure 3C the example of the embodiment of the system 200 shown in, and in Figure 4A and Figure 4B the example of the embodiment of the system 300 shown in, the flexible elongate delivery devices 220, 230 are navigated with the assistance of expandable members 230, 330 including expandable balloon elements 232, 332. The expandable balloon element 232 may be positioned proximal to the distal end 201 of the system 200 (e.g., proximal to the distal end 221 of the flexible elongate delivery device 220), such as Figure 3A , Figure 3B and Figure 3Cas shown. Alternatively, the expandable member 330 can be positioned above the distal end 301 of the system 300 (e.g., above the distal end 321 of the flexible elongate delivery device 320), such as Figure 4A and Figure 4B as shown. The inflation cavities 234, 334 can be in fluid communication / fluid connection with the expandable members 230, 330 to facilitate the expansion of the expandable members 230, 330. For example, the inflation cavities 234, 334 can extend from the respective expandable members 230, 330 to an inflation source at their proximal ends to deliver an inflation medium to the expandable members 230, 330, such as in a manner known to those of ordinary skill in the art. The inflation cavities 234, 334 can be positioned relative to the flexible elongate delivery devices 220, 320 in any of a variety of ways, such as mounted thereon (e.g., with any of a variety of mounting elements, such as clips), or otherwise fixed thereto (e.g., with an adhesive, or with a sleeve extending therearound, such as formed by a shrink-wrap element).

[0045] respectively in Figure 3A 、 Figure 3B and Figure 3C and Figure 4A and Figure 4B the respective expandable members 230, 330 of the systems 200, 300 shown in can facilitate the navigation of the systems 200, 300 in the manner described above with respect to Figure 1 、 Figure 2A 、 Figure 2B and Figure 2C the system 100 shown in. Figure 3A 、 Figure 3B and Figure 3C show various configurations and stages of use of the expandable member 230 that can facilitate the navigation of the system 200. Specifically, the expandable member 230 of the system 200 is shown in FIG. 3 in a delivery configuration, extending into a tortuous body passageway. As Figure 3B shown, the expandable member 230 is expandable to facilitate the navigation of the system 200 through the tortuous body passageway. Once the system 200 is able to navigate through the tortuous body passageway, the expandable member 230 can return to its delivery configuration, such as Figure 3C shown, or alternatively return to a configuration between the delivery configuration and the expanded configuration. Similarly, Figure 4A shows an example of an embodiment of the system 300, where its expandable member 330 is in a delivery configuration, and Figure 4B shows the expandable member 330 in an expanded configuration that can facilitate the navigation of the system 300. This configuration of the system 300 can be in a manner related to Figure 3A 、 Figure 3B and Figure 3C(For the sake of brevity, reference is made to these figures) navigating through the patient and through tortuous body passages of the access in the manner described.

[0046] As Figure 1 , Figure 2A , Figure 2B and Figure 2C shown in the examples of embodiments of system 100 as shown, Figure 3A , Figure 3B and Figure 3C and Figure 4A and Figure 4B the flexible elongate delivery devices 220, 320 of systems 200, 300 respectively shown in

[0047] such as Figure 1 , Figure 2A , Figure 2B , Figure 2C can deliver the devices 210, 310 to the target site TS. The devices 210, 310 can be locator elements 210, 310, such as LEDs or markers visible by any of various imaging techniques (such as those described above in relation to locator element 110), or any of other kinds of devices known to those of ordinary skill in the art. The locator elements 210, 310 can be positioned proximal to the expandable members 230, 330 as shown, or distal to or along or on the expandable members 230, 330 without damaging the various aspects or structures or functions of systems 200, 300. Optionally, a sheath or cannula or similar element (such as known to those of ordinary skill in the art) is provided over elements of systems 200, 300 (e.g., over one or more of the expandable members 230, 330, inflation cavities 234, 334, devices 210, 310, flexible elongate delivery devices 220, 320) to maintain or hold such elements in the desired relative positions with respect to each other.

[0047] such as Figure 1 , Figure 2A , Figure 2B , Figure 2C or Figure 3A , Figure 3B , Figure 3C or Figure 4A or Figure 4B any one of systems 100, 200, 300 shown in Figure 1 can be delivered via an endoscope 150, such as Figure 1 shown in Figure 1 . The endoscope 150 may not be able to extend the full distance to the target site TS, and thus systems 100, 200, 300 can extend beyond the distal end 151 of the endoscope 150, such as Figure 1As shown. Once the systems 100, 200, 300 have been navigated through the patient, as described above, and their distal ends 101, 201, 301 have reached the target site, the devices 110, 210, 310 can be delivered / deployed by the systems 100, 200, 300, as described above, and the endoscope 150 can be withdrawn. In some embodiments, the devices 110, 210, 310 can be left in place at the target site TS, such as by using the expandable members 130, 230, 330 in the expanded configuration to hold the devices 110, 210, 310 in place, so as to withdraw at least a portion of the systems 100, 200, 300 (e.g., at least a portion of the flexible elongate delivery devices 120, 220, 320) from the target site TS.

[0048] It should be understood that, aside from the differences described above, the above systems and devices can be arranged and operated in substantially the same or similar manner. Thus, for the sake of brevity and convenience, and not by way of limitation, common elements having common functions are indicated by the same reference numerals differing by 100, with reference to the description of similar elements and operations.

[0049] It should be understood that the devices, systems and methods described herein can be used in conjunction with procedures to be performed at various locations within a patient's anatomy, such as the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. Thus, although embodiments of the present invention have been described specifically with reference to the GI system, it should be understood that the devices and systems described herein are not so limited. For example, as used in the GI system, the devices, systems and methods disclosed herein can be used to perform a gastrojejunostomy by determining a location at which an anastomosis can be created with the patient's stomach. However, it should be understood that the systems, devices, systems and methods disclosed herein can be used in conjunction with a variety of other medical procedures, such as medical procedures performed within the anatomy of ducts, cavities, blood vessels or body cavities, including, for example, interventional radiology procedures, balloon angioplasty / angiography, thrombolysis procedures, urological or gynecological procedures, etc. The medical devices herein can include a variety of medical devices for catheterizing body cavities, including, for example, catheters, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. The disclosed medical devices and systems can also be inserted via different access points and modalities, for example, percutaneously, endoscopically, laparoscopically or in combination.

[0050] Those of ordinary skill in the art should understand that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the present invention. All of the devices and methods discussed herein are examples of devices and / or methods implemented in accordance with one or more principles of the present invention. These examples are not the only ways to implement these principles, but are merely examples that are not intended to limit the broader aspects of the present invention. Thus, references to elements or structures or features in the drawings must be understood as references to examples of embodiments of the present invention and should not be construed as limiting the present invention to the specific elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those of ordinary skill in the art upon reading the present invention. It should be obvious to those of ordinary skill in the art that variations can be applied to the disclosed apparatus, systems, and / or methods and / or a series of steps of the methods described herein without departing from the concepts, spirit, and scope of the present invention. It should be understood that the various features described with respect to one embodiment can typically be applied to another embodiment, whether or not explicitly stated. The various features described hereinafter can be used alone or in any combination thereof. Thus, the present invention is not limited to the embodiments specifically described herein, and all alternatives and modifications are considered to be within the spirit, scope, and concepts of the present invention as defined by the appended claims. In addition to those discussed above, those of ordinary skill in the art can also understand various further benefits of the various aspects, features, components, and structures of a conveying device or system such as those described above and the associated methods of use.

[0051] The foregoing discussion has broad applicability and has been presented for purposes of illustration and description and is not intended to limit the invention to the forms disclosed herein. It should be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the invention. In particular, for those skilled in the art, the principles of the invention may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from its concept, spirit, or scope or characteristics. For example, for the sake of simplicity, various features of the invention are combined together 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 invention may be combined in alternative aspects, embodiments, or configurations. Although the invention is presented in the form of embodiments, it should be understood that not all of the various individual features of the subject matter need to be present in order to achieve at least some of the desired characteristics and / or benefits of the subject matter or such individual features. Those skilled in the art will understand that the invention may be used with many modifications or variations to the structures, arrangements, proportions, materials, components, and others used in the practice of the invention, which are particularly adapted to specific environments and operational requirements without departing from the principles or spirit or scope of the invention. For example, elements shown as integrally formed may be composed of multiple parts or elements shown as multiple parts that may be integrally formed, the operation of the elements may be reversed or otherwise varied, and the size or dimensions of the elements may be changed. Similarly, although operations or actions or procedures are described in a particular order, this should not be construed as requiring such a particular order, or that all operations or actions or procedures be performed to achieve the desired result. Additionally, other embodiments are within the scope of the following claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve the desired result. Accordingly, the presently disclosed embodiments are 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 arrangements described or shown herein. In view of the foregoing, the individual features of any embodiment may be used and may be claimed separately or in combination with the features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0052] In the foregoing description and the following claims, the following will be understood. As used herein, the phrases "at least one", "one or more", and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a", "an", "the", "first", "second", etc. do not exclude a plurality. For example, as used herein, the term "a" or "an" entity refers to one or more of such entities. Thus, the terms "a" (or "an"), "one or more", and "at least one" are used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally employed in the sense including "and / or" unless the context 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 individually 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, and / or the like) are for identification purposes only to assist the reader in understanding the invention, and / or to distinguish the regions of associated elements from one another, and do not limit the associated elements, particularly not the position, orientation, or use of the invention. Unless otherwise indicated, connection references (e.g., attach, couple, connect, join, and combine) will be construed broadly and may include intermediate members between element assemblies and relative movement between elements. In this regard, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship with each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but rather to distinguish one feature from another.

[0053] The following claims are hereby incorporated by this reference into the detailed description, where each claim stands on its own as a separate embodiment of the invention. In the claims, the terms "comprise", "comprises", "include", and "includes" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Additionally, 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 infeasible and / or advantageous. Additionally, singular references do not exclude plural. The reference signs in the claims are provided only as examples for clarification and should not be construed as limiting the scope of the claims in any way.

Claims

1. A system for navigating within a patient's anatomical structure to a target site within the patient, the system comprising: A flexible elongate delivery device having a distal end that can navigate within the patient's anatomical structure and a proximal end that can be accessed to navigate the flexible elongate delivery device; A device carried by the flexible elongate delivery device along the distal end thereof for deployment at the target site; And An expandable member mounted adjacent the device and capable of transitioning between a delivery configuration and an expanded configuration, the expanded configuration having a cross-sectional dimension greater than that of the delivery configuration.

2. The system according to claim 1, wherein the expandable member comprises one or more flexible elongate elements capable of transitioning from a generally elongated delivery configuration to the expanded configuration.

3. The system according to claim 2, wherein the one or more flexible elongate elements are bowed or curved when in the expanded configuration.

4. The system according to any one of claims 2 to 3, wherein the one or more flexible elongate elements are formed of a shape memory material configured to cause the expandable member to transition to the expanded configuration when a force is applied thereto and to return the expandable member to the delivery configuration when the force is removed therefrom.

5. The system according to any one of claims 1 to 4, wherein the flexible elongate delivery device comprises a flexible tubular element and an actuator extending through the flexible tubular element, the actuator being coupled to the expandable member to cause the expandable member to transition between the delivery configuration and the expanded configuration upon axial translation of the actuator.

6. The system according to claim 5, wherein the proximal end of the one or more flexible elongate elements is coupled to the distal end of the flexible elongate element and the distal end of the one or more flexible elongate elements is coupled to the actuator.

7. The system according to claim 6, wherein proximal retraction of the actuator causes the one or more flexible elongate elements to expand the expandable member to the expanded configuration.

8. The system according to claim 1, wherein the expandable member comprises an inflatable balloon.

9. The system according to claim 8, further comprising an inflation lumen extending along the flexible elongate delivery device and in fluid communication with the inflatable balloon to deliver an inflation medium thereto to cause the inflatable balloon to transition from the delivery configuration to the expanded configuration.

10. The system according to any one of claims 1 to 9, wherein the expandable member is mounted adjacent the distal end of the flexible elongate delivery device, the system further comprising a locator element mounted along or adjacent the distal end of the flexible elongate delivery device.

11. The system according to any one of claims 1 to 10, wherein the expandable member is capable of expanding to have a diameter that is at least half of the inner diameter of the body passageway through which the system is to navigate.

12. A system for navigating within a patient's anatomical structure to a target site within the patient, the system comprising: An endoscope having a working channel extending therethrough; A flexible elongate delivery device having a distal end that can extend distally from the working channel of the endoscope and can be navigated within the patient's anatomy and a proximal end that can be accessed to navigate the flexible elongate delivery device; A device carried by the flexible elongate delivery device along the distal end thereof for deployment at the target site; And An expandable member mounted adjacent the device and capable of transitioning between a delivery configuration and an expanded configuration, the expanded configuration having a cross-sectional dimension greater than that of the delivery configuration.

13. The system of claim 12, wherein the expandable member comprises one or more flexible elongate elements capable of transitioning from a generally elongated delivery configuration to the expanded configuration.

14. The system of claim 12, wherein the expandable member comprises an inflatable balloon.

15. The system of any one of claims 12 to 14, wherein the expandable member is mounted adjacent the distal end of the flexible elongate delivery device, the system further comprising a locator element mounted along or adjacent the distal end of the flexible elongate delivery device.

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