Devices, systems, and methods for moving and / or maintaining anatomical structures in apposition

Abstract

The apposition device includes a first elongated element movably coupled to a second elongated element. The second elongated element is deployable distal to the structure to be apposed and transverse to the first elongated element. The first elongated element may be pulled to pull the second elongated element and bring the structures into apposition. A third element may be positioned proximal to the structures to hold them in apposition. The third element may be a ratchet element lockable in position relative to the first elongated element. The apposition device may be deployed using a fine-gauge needle. The second elongated element is deployed from a side port in the needle to facilitate deployment and / or movement of the second elongated element relative to the first elongated element to the deployed configuration. Such an arrangement may allow control of the first elongated element independently of the needle.

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of devices, systems, and methods for moving anatomical structures into apposition relative to one another and / or holding anatomical structures in apposition relative to one another. More specifically, the present disclosure relates to medical devices, systems, and methods for delivering and deploying anchors configured to hold anatomical structures in apposition. [Background technology]

[0002] Complex endoscopic ultrasound (EUS)-guided procedures (such as those in the gastrointestinal tract) require proper and accurate positioning while maintaining clear ultrasound imaging to safely and effectively perform procedures at the desired access site. Such procedures typically involve a variety of tasks, including, but not limited to, cutting, ablation, and therapeutic device delivery, which require proper and precise positioning and control. While endoscopic imaging modalities such as fluoroscopy and endoscopic ultrasound (EUS) have the ability to visualize anatomical structures beyond the visually accessible tissue proximal to the endoscope, therapeutic endoscopic procedures are limited by the difficulty of controlling tissue beyond the visually accessible tissue plane to the endoscope. Different anatomical sites pose unique challenges in terms of positioning, distance, and geometry. For example, placing a stent between two unattached anatomical structures (e.g., tissue walls) in gastrojejunostomy, hepatogastrostomy, or gallbladder drainage into either the stomach or duodenum is technically challenging due to the lack of tools to visualize, stabilize, and potentially inflate the target site. For example, in certain procedural situations, it can be difficult to properly align and position a stent with a non-adherent anatomical structure (e.g., a tissue wall). For example, advancing a stent between two non-adherent anatomical structures can result in the distal non-adherent anatomical structure being pushed away from the proximal non-adherent anatomical structure. In some situations, the stent may not be able to firmly hold the non-adherent structures in apposition as desired or necessary for the procedure. Furthermore, once a site is accessed, the physician must be able to maintain that access so that the proximal or distal structure does not slip away from or relative to the proximal structure, resulting in the loss of the access site. In some cases, if a distal site moves away from the proximal structure, the distal site cannot be easily reaccessed, leaving a perforation in the distal structure for the patient, which can result in harmful leakage of bodily fluids. All of these issues can lead to failed procedures with serious complications in a patient population that is already in very poor health and has no room for failure.Improvements for delivering and deploying devices that move anatomical structures into apposition and / or hold anatomical structures in apposition would be welcome in the art. Summary of the Invention [Means for solving the problem]

[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 appreciate that each of the various aspects and features of the present disclosure, whether described in this Summary or not, can be advantageously used separately in some cases, or in combination with other aspects and features of the present disclosure in other cases. No limitation on the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0004] In accordance with various principles of the present disclosure, a system for moving and holding proximal and distal anatomical structures in apposition relative to one another is provided. The system includes an apposition device including first and second elongate elements movably coupled relative to one another, a needle having a lumen through which at least the second elongate element is positionable, and a pusher within the needle lumen disposed proximally of the second elongate element. In some embodiments, at least one component of the system is generally structured and configured to facilitate movement of the second elongate element relative to the first elongate element from a delivery position along the first elongate element to a deployed configuration transverse to the first elongate element.

[0005] In some embodiments, a side port is defined in the needle wall through which the second elongate element is configured to be deployed. In some embodiments, a ramp is provided within the needle lumen along the side port to facilitate deployment of the second elongate element from the needle lumen and pivoting the second elongate element to the deployed configuration. In some embodiments, the ramp is formed from a portion of the needle wall that is pressed inwardly into the needle lumen to form the port. In some embodiments, the side port is defined proximal to the distal end of the needle only a distance that allows for deployment of the second elongate element within a small space distal to the distal anatomical structure.

[0006] In some embodiments, the apposition device further comprises a third element disposed proximal to the second elongate element and distal to the pusher and configured to push the second elongate element into the deployed position when pushed distally by the pusher.

[0007] In some embodiments, the third element is configured and positioned to hold the anatomical structures in apposition. In some embodiments, the third element is an expanding element associated with the first elongate element and positioned proximal to the proximal anatomical structure to hold the anatomical structures in apposition. In some embodiments, the first elongate element and the third element are configured to be secured relative to one another to hold the structures in apposition between the third element and the third element. In some embodiments, the first elongate element and the third element include interengaging ratchet features.

[0008] In some embodiments, the needle is a fine gauge needle. In accordance with various principles of the present disclosure, a system for moving and holding proximal and distal anatomical structures in apposition relative to one another is provided, the system comprising: an apposition device including first and second elongate elements movably coupled relative to one another; and a needle having a lumen through which at least the second elongate element can be positioned, the needle having a side port defined in a wall thereof configured for deployment of the second elongate element therethrough.

[0009] In some embodiments, a ramp is provided within the needle lumen along the side port to facilitate deployment of the second elongate element from the needle lumen and pivoting of the second elongate element to the deployed configuration, hi some embodiments, the ramp is formed from a portion of the needle wall pressed inwardly into the needle lumen to form the port.

[0010] In some embodiments, the system includes a third element configured and positioned to hold the anatomical structures in apposition, the third element comprising an expanding element securable relative to the first elongate element proximal to the proximal anatomical structure to hold the anatomical structures in apposition.

[0011] According to various principles of the present disclosure, a method for holding a first anatomical structure and a second anatomical structure in apposition relative to one another uses an apposition device including a first elongate element and a second elongate element movably coupled relative to one another. In some embodiments, the method includes delivering the second elongate element of the apposition device within a lumen of a needle to a deployed position distal to the second anatomical structure, extending the second elongate element from a side port formed in a wall of the needle, moving the second elongate element to a position transverse to the first elongate element, retracting the needle proximally to the anatomical structures, and pulling the first elongate element proximally to retract the second elongate element proximally to move the second anatomical structure into apposition with the first anatomical structure.

[0012] In some embodiments, the first elongate element extends proximally along the exterior of the needle, and the method further comprises pulling the first elongate member proximally to pull the second elongate member to appose the second anatomical structure with the first anatomical structure. In some embodiments, the method further comprises positioning a third element relative to the first elongate element and the first anatomical structure to hold the anatomical structures in apposition.

[0013] In some embodiments, the method further includes advancing the pusher distally through the needle lumen to push the second elongate element out of the side port. In some embodiments, the method further includes pushing the second elongate element along a ramp within the needle lumen to advance the second elongate element out of a side port defined in the needle wall.

[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. [Brief explanation of the drawings]

[0015] [Figure 1] 1 shows a perspective view of an embodiment of an apposition device formed in accordance with various aspects of the present disclosure and disposed in a schematic diagram of a deployed environment. [Figure 2] 1 illustrates an elevation view of an example embodiment of an apposition device formed in accordance with various principles of the present disclosure. [Figure 3] FIG. 3 shows a perspective view of a delivery needle that can be used to deliver an apposition device such as that shown in FIG. 2. [Figure 4A] An example of how an apposition device such as that shown in FIG. 2 can be loaded into a delivery needle such as that shown in FIG. 3 is shown. [Figure 4B] An example of how an apposition device such as that shown in FIG. 2 can be loaded into a delivery needle such as that shown in FIG. 3 is shown. [Figure 5A] 3A-3D illustrate successive stages of delivery and deployment of an apposition device such as that shown in FIG. 2. [Figure 5B] 3A-3D illustrate successive stages of delivery and deployment of an apposition device such as that shown in FIG. 2. [Figure 5C] 3A-3D illustrate successive stages of delivery and deployment of an apposition device such as that shown in FIG. 2. [Figure 6] 1 shows a perspective view of an example embodiment of an apposition device formed in accordance with various principles of the present disclosure having an associated delivery needle; [Figure 7] 7 shows a juxtaposition device as shown in FIG. 6 deployed in a schematic representation of the deployed environment. DETAILED DESCRIPTION OF THE INVENTION

[0016] 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 drawing figures may be changed. For example, a device may be enlarged so that details are discernible, but is intended to be reduced in size, for example, with respect to fitting within the working channel of a delivery catheter or endoscope. In each drawing, identical or nearly identical or equivalent elements are typically labeled with the same reference numeral, and similar elements are typically labeled with a similar reference numeral followed by an '', and redundant description is omitted. For purposes of clarity and conciseness, not every element is labeled in every drawing, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure.

[0017] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference characters represent like elements, as follows: 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 and, as such, may vary. All devices, 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 disclosure. Each example embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Therefore, references to elements or structures or features in the drawings should be recognized 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. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the inventive subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Accordingly, it is intended that the inventive subject matter encompass such modifications and variations as come within the scope of the appended claims and their equivalents.

[0018] It will be understood that the present disclosure is described in this application with varying levels of detail. In some cases, details not necessary for those skilled in the art to understand the present disclosure or that would make other details difficult to appreciate may have been 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.

[0019] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a healthcare professional or clinician or technician or operator or physician, such terms are used interchangeably herein without limitation and include automated control systems, etc.) such as when using the device (e.g., when introducing, implanting, positioning, or delivering the device to a patient) and / or closest to a delivery device, and "distal" refers to a direction or location furthest from a user such as when using the device (e.g., when introducing, implanting, positioning, or delivering the device to a patient) and / or closest to a 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 maintain a fixed configuration when the element flexes or bends, and "axial" refers generally along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement with respect to the above-described systems or elements thereof 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 approximately bisecting the center point and / or being approximately equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line at least approximately bisecting the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or hole. As used herein, "lumen" or "channel" or "bore" or "passage" is not limited to a circular cross-section. As used herein, the "free end" of an element is the terminus of such element that does not extend beyond the free end. It will be understood that terms such as at, on, adjacent to, or along can be used interchangeably herein without limitation, unless otherwise stated, and are intended to indicate general relative spatial relationships, rather than precisely defined locations.Finally, references "at" a location or site are intended to include at and / or near (e.g., along, adjacent, etc.) such location or site.

[0020] In accordance with various principles of the present disclosure, non-adherent anatomical structures (e.g., tissue walls of the same or different anatomical structures, such as organs, blood vessels, muscles, etc.) are held in apposition with an apposition device, thereby enabling medical professionals to safely anchor the site while maintaining endoscopic ultrasound imaging, establish and maintain access to the non-adherent anatomical structures during device exchange, and improve the safety profile of the procedure (e.g., EUS-guided procedure). While reference is made to non-adherent structures, it should be understood that the present disclosure need not be so limited and may also apply to anatomical structures that may adhere to one another, at least to some extent.

[0021] In accordance with various principles of the present disclosure, the apposition device includes a first elongate element and a second elongate element. The second elongate element and a portion of the first elongate element are passed through two adjacent non-adhered anatomical structures from a location proximal to the proximal ends of the non-adhered anatomical structures to a location distal to the two non-adhered anatomical structures. For convenience, and without limitation, the pathway / passage through the non-adhered anatomical structures through which the second elongate element passes to reach its location distal to the distal ends of the non-adhered anatomical structures is referred to herein as a "puncture site." The second elongate element is delivered to a location distal to the non-adhered anatomical structures in a position substantially parallel to the longitudinal axis of the first elongate element and / or needle (to facilitate delivery and / or passage through the non-adhered anatomical structures). It will be understood that references to the longitudinal axis herein may be relative to the longitudinal axis of the needle, the first elongated element, and / or the system, as would be understood by one of ordinary skill in the art given the context of the reference. When the second elongated element is distal to the distal end of the non-adhered anatomical structure, the second elongated element is pivoted relative to the first elongated element (e.g., about an axis lateral to the longitudinal axis of the first elongated element) to a position transverse to the longitudinal axis of the first elongated element. Thus, the second elongated element can be considered a T-bar or T-anchor element. It should be understood that the second elongated element may additionally or alternatively be rotationally coupled to the first elongated element (e.g., about the longitudinal axis of the first elongated element).

[0022] The second elongate element is formed from a material that resists being pulled through the puncture site. In some embodiments, the second elongate element is more rigid than the first elongate element. In some embodiments, the first elongate element is a flexible elongate element such as a suture, tether, wire, string, cord, thread, band, etc. (such terms are used interchangeably herein), and will typically be referred to herein as a suture for convenience and without limitation. In some embodiments, the second elongate element is a rod formed from a biocompatible metal (e.g., nitinol, stainless steel, surgical alloy, etc.) or a biocompatible polymer (e.g., polycarbonate, ABS, rigid PVC, acetal, rigid urethane, polyetheretherketone (PEEK), nylon, polyimide, etc.), or a combination thereof.

[0023] In accordance with various principles of the present disclosure, the apposition device can be delivered using a needle that provides a length, presence of a stylet, cutting tip, echogenicity, etc. suitable for use in apposing tissue, such as a needle used in fine needle aspiration procedures ("FNA" needle) or a needle used in fine needle biopsy ("FNB" needle). FNA needles are typically manufactured in a configuration that is compatible with endoscopic procedures (e.g., compatible for use with an echoduodenoscope). Typically, FNA needles are minimally invasive, generally flexible needles with a lumen extending therethrough through which a stylet may extend. The FNA needle may be a 27 gauge needle (typically having an outer diameter of approximately 0.413 mm, an inner diameter of 0.21 mm, and a wall thickness of 0.102 mm), but may also be a 25 gauge needle (typically having an outer diameter of approximately 0.515 mm, an inner diameter of 0.153 mm, and a wall thickness of 0.127 mm), a 22 gauge needle (typically having an outer diameter of approximately 0.718 mm, an inner diameter of 0.413 mm, and a wall thickness of 0.152 mm), or even a 19 gauge needle (typically having an outer diameter of approximately 1.067 mm, an inner diameter of 0.686 mm, and a wall thickness of 0.191 mm), or other sizes acceptable for delivery of an apposition device according to the various principles of the present disclosure as would be understood by one of skill in the art.

[0024] In some embodiments, the apposition device is delivered using an FNA needle having a side port communicating with a lumen extending longitudinally therethrough. A second elongate element of the apposition device is insertable through the side port into the needle lumen and delivered to a deployment site distal to the distal non-adherent anatomical structure. The first elongate element may extend from the needle side port and proximally toward the proximal end of the needle for access and control by a medical professional. It will be understood that terms such as control, manipulate, move, navigate, and other grammatical forms thereof may be used interchangeably herein without limitation. Once the distal end of the needle is positioned in the appropriate deployment position, the first elongate element may be pulled to retract and deploy the second elongate element. The second elongate element may then be pivoted to a position that crosses the first elongate element, such as by moving along the distal surface of the distal non-adhesive anatomical structure and across a passage through the non-adhesive anatomical structure through which the second elongate element was delivered.

[0025] In some embodiments, the apposition system includes an apposition device and a deployment system configured to facilitate deployment of the apposition device. In some embodiments, the apposition device is configured to maintain the non-adhered anatomical structures in apposition using a third element of the apposition device. The third element may be a locking or fixation element configured to hold the non-adhered anatomical structures in position relative to one another, such as by being fixed relative to the second elongate element. The third element remains proximal to the proximal ends of the non-adhered anatomical structures. In some embodiments, the third element is movable relative to the first and second elongate elements. The first element may be pulled proximally and / or the third element may be advanced distally, such as with a deployment lumen, toward the second element to tighten the apposition device and hold the non-adhered anatomical structures in apposition. In some embodiments, the third element is configured to be locked in position relative to the first element. For example, the third element and the first element may have cooperating engaging elements that hold the third element in a selected position relative to the first element to hold the non-adhered anatomical structures in apposition.

[0026] Various embodiments of devices, systems, and methods for apposing non-adhered anatomical structures and / or for maintaining non-adhered anatomical structures in apposition are described below with reference to examples illustrated in the accompanying drawings. References herein to "one embodiment," "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 the 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 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 properties described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Moreover, references to “one embodiment,” “embodiment,” “some embodiments,” “other embodiments,” etc. in various places herein do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily mutually exclude other embodiments. Furthermore, it is understood that the various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another and can be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of the present disclosure. Accordingly, the present disclosure is not limited to only the embodiments specifically described herein, and it would be extremely tedious to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties, and the example embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure.The following description is merely illustrative of embodiments and is not intended as limiting the broader aspects of the present disclosure.

[0027] Referring now to the drawings, an example embodiment of apposition device 100 is shown in a schematic diagram of an exemplary deployment site for holding non-adhered anatomical structures PS, DS of a patient's body in apposition. In particular, the illustrated example embodiment of apposition device 100 is shown deployed across a proximal anatomical structure PS and a distal anatomical structure DS to hold such structures together in apposition. In the illustrated example of the embodiment, the proximal anatomical structure PS is (e.g., its wall) the patient's stomach S, and the distal anatomical structure DS is (e.g., its wall) the patient's jejunum J. However, it will be understood that the principles of the present disclosure are applicable to other anatomical structures, such as, without limitation, non-adhered anatomical structures to be held in apposition. Typically, one such non-adhered anatomical structure may be considered a proximal non-adhered anatomical structure, and the other non-adhered anatomical structure may be considered a distal non-adhered anatomical structure, generally in the direction toward a medical professional apposing such structures and / or toward which apposition device 100 is deployed in proximity to such structures. While non-adhered anatomical structures PS, DS are shown as tissue walls, they need not be so limited. Once apposition device 100 is deployed, further procedures, such as the formation of an anastomosis between the stomach S and the jejunum J and / or the evacuation of material from one non-adhered anatomical structure to the other, may be performed using apposition device 100 to maintain the structures in apposition relative to one another.

[0028] 1 has a first elongate element 110 extending through the proximal non-adhered anatomical structure PS and the distal non-adhered anatomical structure DS, a second elongate element 120 distal to the distal non-adhered anatomical structure DS, and a third element 130 proximal to the proximal non-adhered anatomical structure PS along a portion of the first elongate element 110. More specifically, the second elongate element 120 is positioned and configured (sized, shaped, dimensioned, formed from a material, etc.) to resist being pulled proximally through the puncture site. For example, the second elongate element 120 may be positioned transverse to the first elongate element 110 and be sufficiently long, resistant to bending, etc., to resist being pulled proximally through the puncture site. The third element 130 is positioned and configured (e.g., sized, shaped, dimensioned, formed from a material, etc.) to resist being pulled distally through the puncture site and to hold the apposition device 100 in place relative to the non-adhered anatomical structures PS, DS. For example, the third element 130 may be an enlarged element positioned against the proximal side of the proximal non-adhered anatomical structures PS at a location relative to the second elongate element 120 to hold the non-adhered anatomical structures PS, DS in apposition with an appropriate holding force. The third element 130 may be a separate element that is selectively positionable relative to the second elongate element 120 and movable (e.g., slidable) relative to the first elongate element 110 to achieve the desired retention of the non-adhered anatomical structures PS, DS in apposition relative to one another. Alternatively, the third element 130 may simply be a knot tied in the first elongate element 110 or other formation (e.g., welding, crimping, application of material, etc.) made in situ to modify the first elongate element 110 to hold the non-adhered anatomical structures PS, DS in apposition. It is believed that the second elongate element 120 and the third element 130 function in conjunction with one another to hold the non-adhered anatomical structures PS, DS in apposition.

[0029] In the example embodiment of apposition device 100 shown in FIG. 2 , first elongate element 110 is a flexible elongate element, such as a suture, tether, wire, string, cord, thread, band, or the like, capable of extending through non-adhered anatomical structures and holding them in apposition without damaging or otherwise interfering with the function of such structures. First elongate element 110 may have a flexibility selected so as not to interfere with the advancement of a device (e.g., a needle) delivering first elongate element 110 and / or so as not to interfere with the advancement of first elongate element 110 through the anatomical tissue. First elongate element 110 may have a length that allows its distal end 111 to be deployed in the non-adhered anatomical structure and a proximal end that is extendable (either directly or via another control element) to a control handle (formed in a manner known to those skilled in the art) or outside the patient's body for manual control (e.g., grasping first elongate element 110 by the hand of a medical professional, either directly or via another element). The flexibility of the first elongate element 110 allows the first elongate element 110 to fit within a lumen of a delivery device or along a delivery device that navigates transluminally through a patient's body.

[0030] 2, second elongate element 120 is an elongate element pivotally coupled to first elongate element 110. Distal end 111 of first elongate element 110 may be coupled to second elongate element 120 in any of a variety of manners known to those skilled in the art, such as bonding (e.g., with an adhesive, or ultrasonic bonding, or welding, or another chemical type of bonding) and / or mechanical bonding (e.g., crimping, having an enlarged end such as a knot or enlarged adhesive bead that extends through an opening through second elongate element 120 and prevents withdrawal therefrom, or another type of interference fit), although the present disclosure is not limited in this manner. The second elongate element 120 may be coupled with the first elongate element 110 and movable between a delivery position in which it is generally aligned or otherwise extends along the first elongate element 110 to facilitate delivery to a deployment site (e.g., transluminal delivery), such as to facilitate delivery through a puncture site, and a deployed position in which it is generally transverse to the puncture site. In the deployed position, the second elongate element 120 may be anchored distal to the non-adhered anatomical structure (e.g., to a distal surface distal to the non-adhered anatomical structure). For example, in the deployed position, the second elongate element 120 may extend (e.g., along its elongate extent / longer dimension) both across the deployment site and transverse to the puncture site. In some embodiments, the first elongate element 110 is coupled to the second elongate element 120 along a mid-region of the second elongate element 120 (between the ends 121, 123 of the second elongate element 120). The location at which the first elongate element 110 is coupled to the second elongate element 120 may be the midpoint between the ends 121, 123 of the second elongate element 120, or any other location that facilitates pivoting of the second elongate element 120 in response to pulling the first elongate element 110 proximally to pull the second elongate element 120 against the anatomical structure. The second elongate element 120 preferably resists backing out of the deployment site, such as being retracted proximally through a puncture site, after being deployed distally of the non-adherent anatomical structure.For example, second elongate element 120 may be sufficiently resistant to bending so that second elongate element 120 cannot be pulled through the passage of the apposition device. Optionally, second elongate element 120 is less flexible than first elongate element 110.

[0031] Illustrated examples of embodiments of second elongate element 120 are in the form of a bar, slug, anchor, tubular element, or other generally elongate element that can move (e.g., pivot) relative to first elongate element 110 and can be anchored distally of the non-adhered anatomical structures held in apposition by apposition device 100. Second elongate element 120 is sized, shaped, configured, and / or dimensioned to secure apposition device 100 distally of the apposed non-adhered anatomical structures. In some embodiments, second elongate element 120 is a solid rod (flat, cylindrical, or otherwise). Alternatively, second elongate element 120 may be tubular with a lumen. The second elongated element 120 may be long enough to facilitate anchoring to an anatomical structure (e.g., a tissue wall) and remain in place within the tissue, yet short enough (e.g., approximately 1-2 cm in length) to easily exit the device upon delivery. The second elongated element 120 may be formed from any preferably biocompatible material, such as a metal (e.g., nitinol or stainless steel), a polymer, or a combination thereof. In some embodiments, the material of the second elongated element 120 is selected to be visible under ultrasound and / or fluoroscopy to facilitate placement, such as to confirm the orientation of the second elongated element 120 in a desired anchoring position relative to a non-adherent anatomical structure. As will be appreciated by those skilled in the art, the texture and / or stiffness and / or other properties of the second elongated element 120 may be selected to improve visibility under ultrasound or other imaging techniques. For example, the second elongate element 120 may have a surface treatment configured to optimize the ultrasound response for the orientation, placement, etc. of the second elongate element 120. Imaging techniques may be used to confirm the desired distance between the apposed non-adhered anatomical structures, such as by visualizing a delivery device (e.g., an endoscope) proximal to the non-adhered anatomical structure and the second elongate element 120 distal to the apposed non-adhered anatomical structure.The first elongate element 110 may be pulled proximally to feel the resistance of the second elongate element 120 against the non-adherent anatomical structure to confirm anchoring of the second elongate element 120 .

[0032] In accordance with various principles of the present disclosure, the apposition device 100, as shown in FIG. 2, can be delivered using a needle. The needle may be a fine-gauge needle, such as those used for fine-needle aspiration, as known to those skilled in the art. In accordance with various further principles of the present disclosure, a modified needle 150, as shown in FIG. 3, can be used. The modified needle 150 has a side port 152 defined in its wall, allowing lateral access to a lumen 155 defined longitudinally therein (along the longitudinal axis LA of the needle 150). The side port 152 may be formed in any of a variety of manners known to those skilled in the art (e.g., punched, laser cut, etc.). In some embodiments, a portion of the wall of the needle 150 is cut and pressed inward to form the side port 152 as well as a ramp 154 ​​that extends into the lumen 155 of the needle 150. The ramp 154 ​​may be sized and positioned within the needle lumen 155 so as to maintain the functionality of the lumen 155, such as by not occluding it. For example, beveled portion 154 may be sized / positioned so as not to block the passage of material (e.g., gas, liquid, or other medium) from the proximal end of needle 150 (which may be connected to a fluid and / or vacuum source) to the distal end 151 of needle 150. Side port 152 allows for delivery of second elongate element 120 into lumen 155 of needle 150, with first elongate element 110 extending outwardly and proximally along needle 150. Such a configuration, as will be understood by one skilled in the art, allows an apposition system (including apposition device 100 and various delivery and / or deployment devices configured to deliver and deploy apposition device 100, including, but not limited to, needle 150 and other devices described below) to maintain a sufficiently narrow profile to be delivered transluminally within the body to a selected deployment site of apposition device 100. Optionally, ramp 154 ​​may be sized and positioned to facilitate movement of second elongate element 120 in and out of lumen 155, as described in more detail below.

[0033] Apposition device 100 (such as apposition device 100 shown in FIG. 2 ) can be delivered to a deployment site using a needle 150 having a side port 152 (as shown in FIG. 3 ) by back-loading second elongate element 120 into lumen 155 of needle 150 through side port 152 in the manner shown in FIGS. 4A and 4B . As shown in FIG. 4A , end 121 of second elongate element 120 is inserted into side port 152 of needle 150 with second elongate element 120 (e.g., the longitudinal extent of second elongate element 120 extending between ends 121, 123) transverse to longitudinal axis LA of needle 150. Second elongate element 120 may be guided into needle lumen 155 by a ramp 154 ​​within lumen 155. A ramp 154 ​​may be formed or provided within the needle lumen 155 to facilitate loading of the second elongate element 120 therein and deployment therefrom when the needle 150 reaches the deployment site. The second elongate element 120 may be positioned within the lumen 155 for delivery substantially aligned with the longitudinal axis LA, as shown in FIG. 4B . The first elongate element 110 may extend from a position within the lumen 155 (where the distal end 111 of the first elongate element 110 is coupled with the second elongate element 120 within the needle lumen 155) through the side port 152. The first elongate element 110 may then extend proximally along (e.g., alongside) the needle 150 to a position where the proximal end of the first elongate element 110 can be accessed to control the apposition device 100. Those skilled in the art will understand that selection of the appropriate geometry of second elongate element 120 and side port 152 and ramp 154, as well as the diameter / thickness of first elongate element 110, will facilitate the desired interaction of the components of the apposition system when delivering and deploying apposition device 100.

[0034] Positioning first elongate element 110 outside of lumen 155 of needle 150 may allow first elongate element 110 to be controlled substantially independently of needle 150. For example, it may be desirable to adjust the position of apposition device 100 by pulling first elongate element 110 to pull second elongate element 120 and move the non-adhered anatomical structures into apposition relative to one another. Positioning first elongate element 110 outside of needle 150 may facilitate control of first elongate element 110 and / or reduce the possibility of interference by needle 150. Additionally or alternatively, running first elongate element 110 proximally from second elongate element 120 outside of needle 150 allows for withdrawal of needle 150 independently from first elongate element 110, such as once second elongate element 120 is deployed, and / or allows for adjustment of first elongate element 110 and second elongate element 120 independently from needle 150 once deployed. Because first elongate element 110 does not extend through needle 150, needle 150 can be withdrawn proximally from the non-adhered anatomical structure without interfering with apposition device 100. If desired, needle 150 can be withdrawn, another apposition device can be loaded against needle 150, and needle 150 can be advanced to the non-adhered anatomical structures held in place by the initially delivered apposition device 100 to deliver another apposition device (e.g., an apposition device adjacent to and spaced from the initially delivered apposition device 100) to provide further fixation of the non-adhered anatomical structures PS, DS as shown in FIG. 1.

[0035] Placing at least a portion of apposition device 100 through side port 152 of needle 150 allows such portion of apposition device 100 to be deployed distally from side port 152 rather than through distal end 151 of needle 150. Such a configuration may protect first elongate element 110 and second elongate element 120 from the potentially sharp needle distal end 151. Furthermore, by deploying second elongate element 120 transverse to longitudinal axis LA of needle 150, less space may be required distal to distal end 151 of needle 150 at the deployment site. For example, if the distal non-adhered anatomical structure to be apposed is the jejunum J or a blood vessel or small organ, the deployment site of second elongate element 120 may not provide much space for deployment of distal end 151 of needle 150 and apposition device 100 distally therefrom. Additionally, the side port 152 may be formed near or adjacent to the distal end 151 of the needle 150 to facilitate delivery of the second elongate element 120 within small spaces so that the distal end 151 of the needle 150 does not have to be advanced excessively to position the side port 152 distal to the non-adherent anatomical structure for deployment of the second elongate element 120.

[0036] An example of how an example embodiment of an apposition system formed in accordance with various principles of the present disclosure may be used to deliver and / or deploy an example embodiment of apposition device 100 (which may, in some aspects, be considered part of the apposition system) is shown in FIGS. 5A-5C.

[0037] The apposition device 100 may be backloaded onto the needle 150, such as in the manner described above (e.g., the second elongate element 120 is inserted / loaded into the side port 152 of the needle 150, and the first elongate element 110 is extended proximally). The needle 150 and apposition device 100 may then be introduced into the endoscope 160 (into the working channel 165 of the endoscope 160). The endoscope 160 is advanced to the desired / indicated / selected deployment site in a manner known to those skilled in the art. For example, as illustrated in FIG. 5A , natural orifice transluminal endoscopic surgery (NOTES) may be used to extend the endoscope 160 into the patient's stomach S through the patient's mouth (not shown). The deployment site of the apposition device 100 may be determined in any of a variety of ways known to those skilled in the art. For example, ultrasound, fluoroscopy, or other imaging techniques may be used. In some examples, a beacon (e.g., an optical beacon) may be positioned at the deployment site of the second elongate element 120 (distal to the distal end of the non-adhered anatomical structures PS, DS that are to be apposed to the apposition device 100).

[0038] Once the distal end 161 of the endoscope 160 is positioned for deployment of the apposition device 100 to appose the non-adhered anatomical structures PS, DS, the needle 150 (pre-loaded with the apposition device 100) can be advanced distally from the working channel 162 of the endoscope 160. The needle extends through the proximal anatomical structure PS and through the distal anatomical structure DS, deploying the apposition device 100 distally relative to the distal side of the non-adhered anatomical structures PS, DS. For example, in the example shown in FIG. 5A , the needle 150 extends through the wall of the stomach S and into the jejunum J, deploying the apposition device 100 within the jejunum J. When using the needle 150 as shown in FIG. 3 , the distal end 151 of the needle 150 is advanced a sufficient distance so that the side port 152 is distal to the distal anatomical structure DS and spaced from the puncture site therethrough to allow space for deployment of the apposition device 100.

[0039] In some embodiments, the position of needle 150 distal to distal anatomical structure DS is confirmed prior to deployment of apposition device 100. For example, needle 150 and / or portions of apposition device 100 may include a visualization material or marker, such as a radiopaque marker, or may be formed of a material that facilitates imaging thereof. Additionally or alternatively, contrast may be delivered and / or a sample may be taken from the anatomical site of distal tip 151 of needle 150. Accordingly, as described above, beveled portion 154 within needle lumen 155 may be sized, shaped, configured, and / or dimensioned to allow passage of a medium for delivering contrast, etc., and / or for aspirating a sample (e.g., bile to confirm that distal tip 151 is within the gallbladder to be treated).

[0040] With the distal end 151 of the needle 150 properly positioned, the apposition device 100 can be deployed. For example, the second elongated element 120 may be deployed out of the side port 152 of the needle 150, such as by pulling the first elongated element 110. Additionally or alternatively, the second elongated element 120 may be deployed by pushing the second elongated element 120 with a pusher 170 (e.g., an elongated element such as a stylet) that extends through the proximal needle lumen 155 of the second elongated element 120 once loaded therein, as illustrated in FIG. 5B . The pusher 170 may be configured to mate with and facilitate engagement with the second elongated element 120. For example, the pusher 170 may have a widened blunt configured to facilitate engagement with and pushing the second elongated element 120. As discussed above with reference to the configuration of the ramp 154, it will be appreciated that if functionality of the needle lumen 155 is to be maintained, the pusher 170 will be dimensioned to also allow passage of material through the lumen 155. Sliding of the second elongate element 120 along the ramp 154 ​​may facilitate its deployment from the side port 152.

[0041] Once the second elongate element 120 is deployed from the needle 150, the first elongate element 110 may be used to orient the second elongate element 120 relative to the distal anatomical structure DS and seat it against its distal surface. The first elongate element 110 may be coupled to the second elongate element 120 to facilitate orientation of the second elongate element 120. For example, the first elongate element 110 may be coupled between (e.g., midway between) the ends 121, 123 of the second elongate element 120, such that pulling the first elongate element 110 proximally orients the second elongate element 120 across the puncture site. The first elongate element 110 may be pulled proximally and retracted to appose the distal anatomical structure DS with the proximal anatomical structure PS, as illustrated in FIG. 5C . Third element 130 may be positioned proximal to the non-adhered anatomical structures PS, DS to hold apposition device 100 in place along with structures PS, DS, as shown in Figure 1. Once apposition device 100 has been deployed and / or the non-adhered anatomical structures PS, DS are securely held in apposition, needle 150 and optional pusher 170 may be retracted outside the patient's body.

[0042] One or more additional apposition devices may be delivered and deployed (e.g., by methods as described above or otherwise) as desired / medically indicated. For example, two or more apposition devices may be recommended to achieve a secure hold on certain non-adherent anatomical structures to maintain the structures in apposition. The apposition devices may be spaced apart from one another, if desired. The additional apposition devices may be the same as apposition device 100 described above, or may be of different configuration. In some embodiments, needle 150 can accommodate two or more apposition devices 100 such that after deployment of the first apposition device 100, needle 150 does not need to be withdrawn to deploy a second, third, etc., apposition device 100.

[0043] Another example embodiment of an apposition device 100' is shown in FIG. 6. Similar to the apposition device 100 described above, the example embodiment of the apposition device 100 shown in FIG. 6 has a first elongate element 110' coupled at its distal end 111' to a second elongate element 120' extending proximally, such as for control by a medical professional. The second elongate element 120' is movably (e.g., pivotally and / or rotatably) coupled to the first elongate element 110'. The second elongate element 120' is configured to be positioned at a deployment site distal to the distal end of the non-adhered anatomical structures to be held in apposition. Once at the deployment site, the second elongate element 120' is movable from a delivery position extending generally along the first elongate element 110' (e.g., parallel to its longitudinal axis) to a deployed position generally transverse to the first elongate element 110', as illustrated in FIG. 7. In its deployed position, the second elongate element 120' is positioned at least distally of the non-adherent anatomical structure to prevent accidental proximal withdrawal from its deployment site (e.g., to prevent withdrawal of the second elongate element 120' through the puncture site through which it was delivered to its deployment site). The materials and other properties of the first elongate element 110' and the second elongate element 120' may be similar to those described above with respect to the first elongate element 110 and the second elongate element 120, and references thereto will be made for brevity. In some embodiments, at least the second elongate element 120' may be molded and / or overmolded with an elastic material. For example, an elastic material such as Pebax® may be molded over the second elongate element 120' to allow some movement of the second elongate element 120'. Alternatively, the second elongate element 120' may be molded with a more rigid biocompatible polymer such as PEEK. However, in some embodiments, first elongate element 110' and second elongate element 120' have various other characteristics that may generally be suited or suitable for the unique characteristics of apposition device 100', as described herein.

[0044] In accordance with various principles of the present disclosure, the example embodiment of apposition device 100' shown in FIG. 6 includes a third element 130' movably coupled / attached to first elongate element 110'. Similar to the third element 130 described above, third element 130' is configured to hold apposition device 100' in a desired position relative to the non-adhered anatomical structures PS, DS, e.g., maintain a desired holding force against the non-adhered anatomical structures to hold them in apposition. In the example embodiment illustrated in FIG. 6, first elongate element 110' and third element 130' are configured to engage, interengage, lock, interlock, mate, fit (e.g., using an interference fit), interfit, etc. (such terms and other grammatical forms are used interchangeably herein without any limitation intended) to secure their relative positions. For example, in the illustrated example embodiment, first elongate element 110′ and third element 130′ include mating features 112′, 132′ configured to mate and hold third element 130′ in place relative to first elongate element 110. Mating features 112′, 132′ can be sized, shaped, configured, and / or dimensioned to facilitate incremental relative movement of first elongate element 110′ and third element 130′, for example, allowing incremental adjustment of the holding force of apposition device 100′ against non-adhered anatomical structures. More specifically, the illustrated example embodiment of third element 130′ is in the form of a ratchet washer 130′ configured to engage and ride over external feature 112′ on first elongate element 110. For example, mating features 112′, 132′ may be configured (e.g., with asymmetric ramps as are typical in ratchet devices) such that when first elongate element 110′ together with second elongate element 120′ are pulled proximally relative to third element 130′, third element 130′ remains in place and does not slide proximally relative to first elongate element 110′ and second elongate element 120′, thereby ensuring that non-adhered anatomical structures PS, DS are apposed securely between third element 130′ and second elongate element 120′.In the example embodiment shown in the detailed view of FIG. 7 , the ratchet washer 130′ has an internal feature 132′ (bump, protrusion, etc.) that rides over the external feature 112′ on the first elongate element 110 in a direction that allows the ratchet washer 130′ to be tightened (pulled toward the second elongate element 120′) against the second elongate element 120′ but not to allow reverse movement (relaxation or movement away from the second elongate element 120′). Other configurations, such as notches, grooves, molded features, etc., are within the scope and spirit of the present disclosure, and the specific details of the mating features 112′, 132′ are not critical to the general principles of the present disclosure. The various sizes, shapes, configurations, and / or dimensions of the mating features 112′, 132′ can be clinically determined, for example, based on any of the various characteristics of the non-adhered anatomical structures to be held in apposition by the apposition device 100′.

[0045] It will be understood that the example embodiment of apposition device 100′ shown in FIG. 6 may be delivered with / as a system and / or in a manner similar to that described above with reference to FIGS. 5A-5C. For example, apposition device 100′ may be delivered to a deployment site using a deployment needle similar to needle 150 described above. However, in some embodiments, second elongate element 120′ of apposition device 100′ is not delivered through a side port of the deployment needle, and thus, a deployment needle used with an apposition system through which apposition device 100′ is delivered and deployed need not include a side port. In contrast to needle 150 described above, deployment needle 180 used to deploy apposition device 100′ shown in FIG. 6 may have a needle lumen 185 that allows passage of apposition device 100′ and a pusher 190 extending therethrough from the distal end 181 of deployment needle 180. Lumen 185 may be considered to be substantially completely unoccluded. More specifically, in contrast to the above-described apposition systems and methods, apposition device 100′ is delivered with a pusher 190 that is sized, shaped, configured, and / or dimensioned to fit within and slidably extend through lumen 185 of deployment needle 180 to push at least second elongate element 120′ out of the distal end 181 of deployment needle 180. In the illustrated example embodiment, second elongate element 120′ of apposition device 100′ is disposed distal to distal end 191 of pusher 190. However, other configurations and arrangements are within the scope and spirit of the present disclosure. For example, pusher 190 may be in the form of a deployment lumen, and second elongate element 120′ may extend partially within a lumen in pusher 190.

[0046] 6 , the second elongate element 120′ is deployed when the distal end 181 of the deployment needle 180 is advanced distally relative to the distal ends of the non-adhered anatomical structures PS, DS to be held in apposition by the apposition device 100′. For example, the deployment needle 180 and / or the pusher 190 are retracted proximally, and / or the second elongate element 120′ is advanced distally from the distal end 181 of the deployment needle 180 (e.g., by being pushed by the pusher 190) to position it distally relative to the distal ends of the non-adhered anatomical structures to be apposed. In some embodiments, the distal end 191 of the pusher 190 is advanced distally from the distal end 181 of the deployment needle 180. The pusher 190 may be advanced distally to move the second elongate element 120′ relative to the first elongate element 110′, moving the second elongate element 120′ to a transverse configuration relative to the first elongate element 110′. In some examples, the pusher 190 can push the third element 130′ distally to cause the third element 130′ to move (e.g., pivot) the second elongate element 120′ relative to the first elongate element 110′. Additionally or alternatively, first elongate element 110' may be retracted proximally, causing second elongate element 120' (e.g., positioned generally parallel to first elongate element 110') to ride along third element 130' and / or move against the distal surface of the non-adhered anatomical structure DS, PS to a deployed position generally transverse to first elongate element 110'. Once second elongate element 120' is deployed, deployment needle 180 (with washer 130' and pusher 190 therein) may be retracted proximally through the puncture site, via the non-adhered anatomical structure DS, PS, to deploy second elongate element 120'. The deployment needle 180 may be retracted further proximally relative to the pusher 190 and apposition device 100' when the distal end 181 of the deployment needle 180 is proximal to the non-adhered anatomical structures DS, PS to deploy the third element 130'.The pusher 190 may then be advanced distally, moving the third element 130' distally relative to the non-adhered anatomical structures DS, PS and the first elongate element 110' to appose and secure the non-adhered anatomical structures DS, PS relative to one another, as illustrated in FIG. 7 . The first elongate element 110' may be cut (e.g., in the case of a suture) or broken (e.g., in the case of a stylet or other frangible element) to leave its shortened portion in place at the deployment site. It will be understood that any or all of the above-described delivery and deployment aspects may be performed using available appropriate imaging techniques as known to those skilled in the art.

[0047] Apposition devices 100, 100' formed according to various principles of the present disclosure can be left in place indefinitely or for a finite period of time. In some embodiments, one or more components of apposition device 100, 100' are formed of biodegradable materials. For example, first elongate element 110, 100' may be a biodegradable suture that naturally dissolves within the patient's body after a selected period of time. Second elongate element 120, 120' and third element 130 (if not part of the biodegradable first elongate element 110, 100') may also be biodegradable or may simply pass naturally from the patient's body.

[0048] In some applications, an additional device, such as a stent, is placed across the non-adhered anatomical structures to secure them together and / or form an anastomosis therethrough or otherwise allow passage of material between the apposed anatomical structures. The additional device may have a retention member configured to hold the device in place relative to the apposed anatomical structures, as known to those skilled in the art. The retention member may be accessed and actuated (e.g., compressed) to allow removal of the additional device as desired or medically indicated. In some cases, the additional device may be left in place indefinitely or for a finite period of time, such as one week, one month, or six months. One example of an additional device is a stent that may be deployed after deployment of the apposition device 100, 100′ formed according to various principles of the present disclosure. For example, a stent may be used to form an anastomosis, such as a gastrojejunostomy, across the anatomical structures (stomach S and jejunum J) of the example environment shown in FIG. 1 . A pylorus obstructing device can be placed in the pylorus to inhibit or prevent the passage of gastric contents into the duodenum and direct the gastric contents into the jejunum, using methods known to those skilled in the art. Use of an apposition device such as described above facilitates the formation of such an anastomosis by holding the jejunum in place relative to the stomach as a stent is delivered from the stomach into the jejunum to form the anastomosis. In some cases, a natural anastomosis forms across the apposed structures and / or the apposed structures remain attached to each other even after removal of the apposition device and / or additional devices. It will be appreciated that other procedures (not necessarily involving the formation of an anastomosis) can also benefit from the use of an apposition device 100 such as described above.

[0049] While embodiments of the present disclosure may be described with specific reference to medical devices and systems and procedures for treating the gastrointestinal system, it should be understood that such medical devices and methods may be used to treat tissues of the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, circulatory system, etc. For example, while the example embodiments shown and described herein are deployed to hold the stomach S and jejunum J in apposition, apposition devices 100, 100′ formed according to various principles of the present disclosure may also be used to hold other anatomical structures in apposition, such as, but not limited to, a patient's gallbladder and portions of the small intestine or stomach.

[0050] It should be understood by those skilled in the art that the present discussion is merely a description of illustrative examples of embodiments and is not intended as a limitation of 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, and are merely examples and are not intended as a limitation of the broader aspects of the present disclosure. Thus, references to elements or structures or features in the drawings should be recognized 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. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this disclosure.

[0051] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so combined unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so combined, alone and in any combination and number, unless the context clearly dictates otherwise. The terms "comprises" and / or "comprising" or "includes" and / or "including," as used herein, specify the presence of stated features, regions, steps, elements, and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0052] In view of the above, it should be understood that the various embodiments shown in the drawings have several distinct and independent features, each of which, at least alone, has desirable, but not essential, inherent advantages for the apposition devices, systems, and methods of the present disclosure. Thus, it is not necessary for all of the various distinct features described herein to be present to achieve at least some of the desired features and / or advantages described herein. Only one of the various features may be present in a device or system 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 and matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Furthermore, throughout this disclosure, numerals are used to denote generic elements or features of the disclosed embodiments. The same numerals may be used to denote 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 rather than numbers) may be used to distinguish similar elements or features from one another.

[0053] 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. While the devices and methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations can be applied to the devices and / or methods, and to the steps or sequence of steps of the methods, described herein without departing from the concept, spirit, and scope of the present disclosure. All such similar substitutes 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. In addition to those described above, various additional advantages of the various aspects, features, components, and structures of the apposition devices, systems, and methods as described above will be apparent to those skilled in the art.

[0054] 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 disclosed herein. It will 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 disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from the concept, spirit, or scope or characteristics thereof. For example, various features of the present 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 a particular aspect, embodiment, or configuration of the present disclosure may be combined in alternative aspects, embodiments, or configurations. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many changes or modifications to the structure, arrangement, proportions, materials, components, and other aspects used in implementing the disclosure to specifically adapt them to particular environments and operating requirements without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise varied, and elements may be sized or dimensioned differently. Similarly, although operations, actions, or steps are described in a particular order, this should not be construed as requiring such a specific order to achieve desired results, or that all operations, actions, or steps should be performed. Furthermore, 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 embodiments disclosed herein 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 the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment can be used and claimed separately or in combination with features of that or any other embodiment, and the scope of the subject matter being indicated by the appended claims and not limited to the foregoing description.

[0055] 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 are both conjunctive and disjunctive in operation. Terms such as "a," "an," "the," "first," and "second" do not preclude 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 combined, unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so combined, alone and 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 used solely for identification purposes to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another and do not limit the related 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 may include intermediate members between a collection of elements and relative movement between the elements unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other.Distinguishing references (e.g., primary, secondary, first, second, tertiary, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0056] The following claims are incorporated into this detailed description by this reference, with each claim standing on its own as a separate embodiment of this 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 in some cases be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a 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. 1. A system for moving and holding proximal and distal anatomical structures in apposition relative to one another, the system comprising: an apposition device comprising a first elongate element and a second elongate element movably coupled relative to one another; a needle with a lumen therethrough capable of positioning at least the second elongate element; a pusher within the needle lumen disposed proximally of the second elongate element; At least one component of the system is structured and configured to facilitate movement of the second elongate element relative to the first elongate element from a delivery position generally along the first elongate element to a deployed configuration that is transverse to the first elongate element.

2. The system of claim 1 , wherein a side port is defined in a wall of the needle through which the second elongate element is configured to be deployed.

3. 3. The system of claim 2, wherein a ramp is provided within the needle lumen along the side port to facilitate deployment of the second elongate element from the needle lumen and pivoting of the second elongate element to the deployed configuration.

4. The system of claim 3 , wherein the bevel is formed from a portion of the needle wall that is forced inwardly into the needle lumen to form the port.

5. 5. The system of claim 2, wherein the side port is defined proximal to the distal end of the needle at a distance that allows deployment of the second elongate element within a small space distal to the distal anatomical structure.

6. 10. The system of claim 1, wherein the apposition device further comprises a third element positioned proximal to the second elongate element and distal to the pusher and configured to urge the second elongate element into the deployed position when pushed distally by the pusher.

7. The system of any one of claims 1 to 6, further comprising a third element constructed and arranged to hold the anatomical structures in apposition.

8. 8. The system of claim 7, wherein the third element is an expanding element associated with the first elongate element and positioned proximal to the proximal anatomical structure to hold the anatomical structures in apposition.

9. 9. The system of claim 6, wherein the first elongate element and the third element are configured to be fixed relative to one another to hold the structure in juxtaposition between the first and third elements.

10. The system of any one of claims 6 to 9, wherein the first elongate element and the third element include interengaging ratchet features.

11. The system of any one of claims 1 to 10, wherein the needle is a fine gauge needle.

12. 1. A system for moving and holding proximal and distal anatomical structures in apposition relative to one another, the system comprising: an apposition device comprising a first elongate element and a second elongate element movably coupled relative to one another; a needle with a lumen therethrough capable of positioning at least the second elongate element; Equipped with A side port is defined in the needle wall through which the second elongate element is configured to be deployed.

13. 13. The system of claim 12, wherein a ramp is provided within the needle lumen along the side port to facilitate deployment of the second elongate element from the needle lumen and pivoting of the second elongate element to the deployed configuration.

14. The system of claim 13 , wherein the ramp is formed from a portion of the needle wall that is forced inwardly into the needle lumen to form the port.

15. 15. The system of any one of claims 12-14, further comprising a third element configured and positioned to hold the anatomical structures in apposition, the third element comprising an expanding element securable relative to the first elongate element proximal to the proximal anatomical structure to hold the anatomical structures in apposition.

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