Devices and systems for delivering devices between anatomical structures

Abstract

An access and delivery device and system configured to facilitate access and delivery to a deployment site of an implantable device includes a tissue-piercing element and an access and delivery device with an anchoring member configured to bend outward laterally relative to the tissue-piercing element. The system can be routed through a proximal non-adhesive anatomical structure to a deployment site in a distal non-adhesive anatomical structure. The anchoring member can be used to maintain the relative position of the non-adhesive anatomical structure and / or to protect the deployment site from the tissue-piercing end of the implantable device delivery and deployment system. The tissue-piercing element can have a soft distal tip configured to atraumatically engage the tissue wall, such as to protect the tissue wall from the sharp tissue-piercing end of the tissue-piercing element.

Description

[Technical Field]

[0001] The present disclosure generally relates to the field of devices, systems, and methods for holding anatomical structures relative to one another and / or moving anatomical structures into apposition with one another. Additionally, the present disclosure generally relates to the field of devices, systems, and methods for delivering and deploying devices across adjacent anatomical structures and protecting tissue of the anatomical structures from the tissue-penetrating tip of a tissue-penetrating element. [Background technology]

[0002] Complex endoscopic ultrasound (EUS)-guided procedures (such as those in the gastrointestinal tract) require proper and precise placement 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, cauterization, and therapeutic device delivery, which require proper and precise placement 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 can be 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 placement, distance, and shape. Placing a stent between two non-adherent anatomical structures (e.g., tissue walls), such as 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 possibly inflate the target site. For example, once the site is accessed, the physician must be able to maintain access so that the proximal or distal structure does not move away from or slip relative to the proximal structure, resulting in loss of access. For example, advancing a stent between two non-adherent anatomical structures may push the distal non-adherent anatomical structure away from the proximal non-adherent anatomical structure. In some instances, once the distal site separates from the proximal structure, it cannot be easily re-accessed, leaving the patient with a perforation in the distal structure, which can result in potentially harmful leakage of bodily fluids. Furthermore, space within distal sites may be limited, and accessing such sites through the proximal wall of such distal sites may carry the risk of perforating the distal wall of such distal sites. All of these challenges can lead to procedural failure with serious complications in a patient population that is already in very poor health and cannot afford to fail.Improvements in delivering and deploying devices across adjacent anatomical structures, optionally holding the anatomical structures in apposition, would be welcome in the art. Summary of the Invention

[0003] This Summary is provided to introduce a selection of concepts in a simplified form that are described in more detail below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. Those skilled in the art will appreciate that each of the various aspects and features of the present disclosure, whether described in this Summary or not, may be advantageously used separately in some instances or in combination with other aspects and features of the present disclosure in other instances. No limitation as to the scope of the claimed subject matter is intended by the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0004] According to various principles of the present disclosure, access and delivery devices and systems are configured to access a deployment site across a proximal tissue wall of an anatomical structure. In some embodiments, the access and delivery devices and systems include a tissue-piercing element having a distal end configured to penetrate the tissue wall, and an access and delivery device having a proximal portion, an anchor member, and a distal tip. In some embodiments, the anchor member is formed of a flexible material different from the material of at least the proximal portion of the flexible elongate element, and the flexible material is configured to flex laterally relative to the tissue-piercing element to form the anchor feature of the system.

[0005] In some embodiments, the anchor member is formed from a shape memory material. In some embodiments, the flexible material of the anchor member has sufficient strength to maintain a bent configuration transverse to the tissue-penetrating element when pulled proximally against the proximal tissue wall through which the system extends.

[0006] In some embodiments, the distal end of the tissue-piercing element is sharp to pierce tissue, and the distal tip of the flexible elongate element is extendable distally beyond the distal end of the tissue-piercing element and is soft to atraumatically engage and protect the tissue wall from the distal end of the tissue-piercing element. In some embodiments, the tissue-piercing element has a window formed therethrough, and the anchor member is extendable through the window to form an anchor feature. In some embodiments, the distal end of the tissue-piercing element and the window are spaced apart from one another, and the distal tip of the flexible elongate element and the anchor member are spaced apart from one another such that when the anchor member extends from the window, the distal tip extends distally beyond the tissue-piercing distal end.

[0007] In some embodiments, the distal tip of the flexible elongate element is soft to atraumatically engage and atraumatically press against the tissue wall. According to various principles of the present disclosure, a system for delivering an implantable device to a deployment site includes an access and delivery system and an access and delivery device. The access and delivery system includes a tissue-piercing element having a distal end configured to penetrate a tissue wall, and the access and delivery device having a proximal portion, an anchor member configured to bend outward laterally relative to the tissue-piercing element, and a soft distal tip capable of atraumatically engaging tissue. The implantable device delivery and deployment system includes the tissue-piercing element and the implantable device. In some embodiments, the anchor member is configured to block distal advancement of the tissue-piercing element of the implantable device delivery and deployment system, and the soft distal tip is configured to block distal advancement of the tissue-piercing element of the access and delivery system.

[0008] In some embodiments, the soft distal tip is configured to atraumatically push the tissue wall distally to create space for the implantable device at the deployment site. In some embodiments, the distal end of the tissue-piercing element is sharp to pierce the tissue, and the distal tip of the access and delivery device is extendable distally beyond the distal end of the tissue-piercing element and is soft to atraumatically engage and protect the tissue wall from the distal end of the tissue-piercing element.

[0009] In some embodiments, the anchor member has sufficient strength to maintain a transversely bent configuration relative to the tissue-penetrating element of the access and delivery system when pulled proximally against the proximal tissue wall through which the system extends.

[0010] In some embodiments, the anchor member has sufficient strength to maintain a transversely bent configuration relative to the tissue-penetrating element of the implantable device delivery and deployment system as the tissue-penetrating element of the implantable device delivery and deployment system is advanced toward and relative to the anchor member, thereby preventing the tissue-penetrating element of the implantable device delivery and deployment system from advancing distally toward the soft distal tip. In some embodiments, the tissue-penetrating element of the implantable device delivery and deployment system has a tissue-penetrating end configured to pierce tissue.

[0011] In some embodiments, the anchor member is formed of a flexible material that is different from the material of at least a proximal portion of the access and delivery device, and the flexible material is configured to bend laterally relative to the tissue penetrating element to form the anchor feature of the access and delivery system. In some embodiments, the anchor member is formed of a shape memory material.

[0012] In accordance with various principles of the present disclosure, a method for accessing a deployment site for an implantable device and facilitating deployment of the implantable device includes penetrating a tissue wall of a proximal anatomical structure with a tissue penetrating element, penetrating a proximal tissue wall of a distal anatomical structure with the tissue penetrating element, advancing an access and delivery device distally through the tissue penetrating element such that a soft distal tip of the access and delivery device advances distally beyond the distal end of the tissue penetrating element, and extending anchor members of the access and delivery device relative to the tissue penetrating element and bending them outward and laterally relative to the tissue penetrating element.

[0013] In some embodiments, the method further includes retracting the anchor member proximally against a proximal tissue wall of the distal anatomical structure to move the proximal wall and the distal anatomical structure toward the proximal anatomical structure.

[0014] In some embodiments, the method further includes advancing the tissue-penetrating tip of the implantable device delivery and deployment system through a tissue wall of the proximal anatomical structure and a proximal tissue wall of the distal anatomical structure, and obstructing distal advancement of the tissue-penetrating tip of the implantable device delivery and deployment system with an anchor member.

[0015] In some embodiments, the method further includes distally advancing an anchor member of the access and delivery device through a window formed in the wall of the tissue-piercing element. In some embodiments, the method further includes advancing the soft distal tip of the access and delivery device distally to atraumatically push a distal tissue wall of the distal anatomical structure away from a proximal tissue wall of the distal anatomical structure.

[0016] 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]

[0017] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures within the drawings may vary. For example, a device may be enlarged so that details can be discerned, but is intended to be reduced in size to fit within the working channel of, for example, a delivery catheter or endoscope. In the drawings, identical, substantially identical, or equivalent elements are typically represented by the same reference numeral, and similar elements are typically designated by similar reference numerals with an "'" prefix, and redundant description is omitted. For clarity and conciseness, not every element is labeled in every figure, and not every element of each embodiment is shown unless illustration is necessary to enable those skilled in the art to understand the disclosure. The detailed description will be better understood in conjunction with the accompanying drawings, as follows, in which like reference numerals represent like elements. [Figure 1] FIG. 1 is a cross-sectional view of one example of an embodiment of an access and delivery device and system, including an implantable device delivery and deployment system, formed in accordance with aspects of the present disclosure. [Figure 2] FIG. 2 shows a cross-sectional view of the access and delivery device and system as shown in FIG. 2, but with the access and delivery device in a deployed configuration. [Figure 3A] FIG. 3A is an elevational view of an access and delivery device and system as shown in FIG. 1 delivering the access and delivery device. [Figure 3B] FIG. 3B is similar to the illustration of FIG. 3A, but with the access and delivery device in a deployed configuration. [Figure 3C] FIG. 3C is similar to the illustration in FIG. 3B, except that the access and delivery device is being used to pull the distal non-adherent anatomical structure proximally toward the proximal non-adherent anatomical structure. [Figure 3D] FIG. 3C is an elevational view of an access and delivery device and system as shown in FIG. 2, where an implantable device delivery and deployment system as shown in FIG. 1 has begun to deliver an implantable device. [Figure 4A] FIG. 4A illustrates an example embodiment of an access and delivery device and system formed in accordance with various principles of the present disclosure and in a delivery configuration. [Figure 4B] FIG. 4B shows an access and delivery device and system as shown in FIG. 4A, but in a deployed configuration. [Figure 5] FIG. 5 illustrates an implantable device delivery system with an example of an embodiment of an access and delivery device and system in a deployed configuration. DETAILED DESCRIPTION OF THE INVENTION

[0018] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the present disclosure is not limited to the particular embodiments described, and as such may vary. All devices, systems, and methods described herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of 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 illustrated. 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 present subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. It is therefore intended that the present subject matter encompass all such modifications and variations within the scope of the appended claims and their equivalents.

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

[0020] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or clinician or technician or operator or physician, etc., such terms are used interchangeably herein without limitation and include an automated controller system, etc.) and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to a direction or location furthest from a user and / or closest to a delivery device, such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "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 generally intersecting the center point and / or generally equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line at least generally intersecting the center point of the opening and extending longitudinally along the length of the opening, where the opening comprises, for example, a tubular element, post, channel, cavity, or hole. As used herein, a "free end" of an element is the terminus beyond which such element does not extend. It will be understood that terms such as at, on, adjacent to, or along an end 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, a reference "at" a location or site is intended to include at such location or site and / or near (e.g., along, adjacent, etc.) such location or site.

[0021] Various medical procedures involve accessing a distal non-adherent anatomical structure from a proximal non-adherent anatomical structure. The non-adherent anatomical structure may be an organ, blood vessel, muscle, etc. formed by a tissue wall surrounding or defining an anatomical lumen, passageway, cavity, etc. within the structure. References herein to anatomical or bodily passageways, etc., will be understood to include naturally occurring passageways (e.g., the jejunum), as well as medically created passageways (e.g., passageways created by the use of medical instruments, such as between the stomach and jejunum), abnormal passageways or structures (e.g., formed due to a pathological condition), or others. In some instances, the non-adherent anatomical structures are held in apposition relative to one another. In some instances, a device can be deployed across the non-adherent anatomical structures to hold the non-adherent anatomical structures in apposition relative to one another. References herein to non-adherent structures are exemplary and not limiting, and it will 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.

[0022] According to various principles of the present disclosure, access and delivery devices and systems are configured to extend across anatomical structures, such as, but not limited to, tissue structures or tissue walls. The devices and systems may be configured to deliver devices across or between anatomical structures, such as, but not limited to, tissue structures or tissue walls. The devices and systems are configured to access a distal anatomical structure (e.g., a non-adhesive anatomical structure) from a proximal anatomical structure (e.g., another non-adhesive anatomical structure) to facilitate delivery of an implantable device to the distal anatomical structure. The implantable device may be extended across the anatomical structure, such as to hold the anatomical structures in apposition. In some embodiments, the access and delivery devices and systems are configured to hold the distal anatomical structure relative to the proximal anatomical structure. This allows the implantable device to be advanced from the proximal anatomical structure to the distal anatomical structure (e.g., by penetrating the tissue wall of the respective anatomical structure) without risk of the anatomical structure being pushed away from the proximal anatomical structure as the implantable device is advanced into the distal anatomical structure. Additionally or alternatively, the access and delivery devices and systems are configured to approximate (e.g., appose) distal anatomical structures to proximal anatomical structures. This allows medical professionals to access target sites (e.g., in distal anatomical structures) from different anatomical sites (e.g., from within the proximal anatomical structure) without the risk of the different sites becoming displaced or separated from one another (e.g., the distal anatomical structure becoming displaced or separated from the proximal anatomical structure). Additionally or alternatively, this allows for the establishment and maintenance of access to anatomical structures during imaging (e.g., endoscopic ultrasound imaging) and device exchange. Various associated benefits, such as an improved safety profile of the procedure (e.g., EUS-guided procedure) and a reduced time required to perform the procedure, can be appreciated by those skilled in the art.

[0023] According to various principles of the present disclosure, access and delivery devices and systems that access distal anatomical structures from proximal anatomical structures can be used to proximally advance the distal anatomical structure (e.g., its tissue wall) on an implantable device that is advanced from the proximal anatomical structure into (e.g., into a cavity therein) the distal anatomical structure. Additionally or alternatively, the access and delivery devices and systems can simply hold the distal anatomical structure sufficiently securely relative to the proximal anatomical structure to which the device is delivered so that the implantable device can be advanced into the distal anatomical structure without shifting the distal anatomical structure relative to the proximal anatomical structure (e.g., moving the distal anatomical structure distally away from the proximal anatomical structure). In some embodiments, an implantable device delivery and deployment system is loaded onto and advanced on the access and delivery devices and systems.

[0024] According to various principles of the present disclosure, access and delivery devices and systems configured to access cavities within distal anatomical structures are configured to facilitate the delivery of implantable devices into such cavities. For example, the access and delivery devices and systems can be configured to extend distally into the distal anatomical structure to hold open the anatomical cavity therein. The access and delivery devices may have a flexible distal end or tip that can protect the distal wall of the distal anatomical structure during the performance of a procedure within the distal anatomical structure (e.g., insertion of a device therein). For example, the flexible tip of the access and delivery device can hold the distal wall of the body lumen away from the proximal wall of the body lumen so that insertion of a device into the body lumen (e.g., a cutting device for forming an access hole in a distal tissue wall) does not inadvertently contact the distal wall of the body lumen. In this manner, providing a flexible tip can protect the wall of the distal anatomical structure during the performance of a procedure therewith. It will be understood that the terms body / anatomical cavity, passageway, lumen, space, and the like may be used interchangeably herein without any intended limitation.

[0025] Various embodiments of access and delivery devices and systems and related methods are described below with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. indicate that one or more particular features, structures, concepts, and / or characteristics according to 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 one 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 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 can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive of other embodiments. Moreover, it is to be understood that the various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another and may be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of this disclosure. Accordingly, since it would be prohibitively cumbersome to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties, the present disclosure is not limited to only the embodiments specifically described herein, and the example embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure.It should be understood that the various dimensions provided herein are examples, and that one of ordinary skill in the art can readily determine appropriate ranges of standard deviation and acceptable variation therefrom that are encompassed by the present disclosure and any claims associated therewith. The following description is merely an illustrative example of an embodiment and is not intended as a limitation on the broader aspects of the present disclosure.

[0026] In the drawings, it will be understood that common features are identified by common reference elements, and for brevity and convenience, without intent to be limiting, descriptions of common features generally will not be repeated. For clarity, not all components having the same reference number are numbered. Furthermore, groups of similar elements may be indicated by numbers and letters, and generally, one may refer to one element or such elements, or such elements as a group, by the number alone (without including the letter associated with each similar element). Furthermore, specific features in one embodiment may be used across different embodiments and are not necessarily individually labeled when appearing in different embodiments.

[0027] Referring now to the drawings, an example embodiment of an access and delivery system 100 is shown in conjunction with an implantable device delivery and deployment system 1000. In the illustrated example embodiment, the access and delivery system 100 extends through / is mounted on the implantable device delivery and deployment system 1000. The access and delivery system 100 is configured to access a deployment site of an implantable device 1010 delivered and deployed by the implantable device delivery and deployment system 1000. The access and delivery system 100 can be extended through a proximal anatomical structure, such as a proximal non-adherent anatomical structure, and into a distal anatomical structure, such as a distal non-adherent anatomical structure, to access a deployment site within the distal non-adherent anatomical structure. Additionally or alternatively, the access and delivery system 100 is configured to facilitate deployment of the implantable device 1010. Additionally or alternatively, in procedures in which the implantable device 1010 is deployed from a proximal anatomical structure to a distal anatomical structure, the access and delivery system 100 is configured to hold the distal anatomical structure relative to the proximal anatomical structure to facilitate delivery and deployment of the implantable device 1010. Additionally or alternatively, the access and delivery system 100 is configured to protect the distal wall of the distal anatomical structure from components of the implantable device delivery and deployment system 1000.

[0028] More specifically, the example embodiment of the access and delivery system 100 shown in FIG. 1 includes a tissue-piercing element 110 having a tissue-piercing tip 112 at its distal end 111. The tissue-piercing tip 112 may be configured to penetrate the tissue wall of a non-adherent anatomical structure to form an initial access opening through the non-adherent anatomical structure for delivery of the implantable device 1010 (delivered by the implantable device delivery and deployment system 1000). For example, the tissue-piercing tip 112 may be sufficiently sharp to puncture the tissue wall. The access and delivery device 120 may be in the form of a flexible, elongated element extending through a lumen 115 defined through the tissue-piercing element 110. The access and delivery device 120 may include a guidewire or other element to facilitate delivery of the implantable device 1010.

[0029] In accordance with various principles of the present disclosure, as shown in FIGURE 1 , access and delivery device 120 includes anchor member 122 configured to secure access and delivery device 120 relative to a distal non-adherent anatomical structure relative to which implantable device 1010 is deployed. Anchor member 122 is formed from a flexible material capable of bending transversely relative to at least a proximal portion 124 of tissue-piercing element 110 and access and delivery device 120, forming anchor feature 130 of access and delivery device 120 and access and delivery system 100 as shown in FIGURE 2. For example, anchor member 122 can extend outward from lumen 115 of tissue-piercing end 112 through a window 117 formed in the wall of tissue-piercing element 110. Anchor member 122 may be formed of a shape-memory material (e.g., Nitinol, Elgiloy®, etc.) such that advancing access and delivery device 120 distally relative to tissue-piercing element 110 to align anchor member 122 with window 117 allows anchor member 122 to bend outward from window 117 without the need for further manipulation. Anchor member 122 may be formed from one or more (e.g., two or more as shown in the accompanying drawings) flexible, elongated elements. In some embodiments, anchor member 122 is formed by splicing a thin, flexible element between proximal portion 124 and distal tip 126 of access and delivery device 120. Anchor member 122, proximal portion 124, and soft distal tip 126 of access and delivery device 120 may be joined together in any of a variety of ways known to those skilled in the art, such as welding, adhesive bonding, soldering, brazing, or any of a variety of mechanical fittings (e.g., crimping). In some embodiments, anchor member 122 is formed by splitting a flexible elongated element, such as a guidewire, into two or more thinner, more flexible elements.It will be understood that terms such as flexing, bending, bowing, and other grammatical forms thereof may be used interchangeably herein without any limitation.

[0030] The anchor feature 130 expands outward relative to the tissue-piercing element 110 to prevent retraction of the access and delivery device and system 100 as the tissue-piercing element 110 is extended through the tissue wall. In the expanded configuration of the anchor member 122, with the anchor feature 130 disposed within the distal non-adhesive anatomical structure, the access and delivery device and system 100 can hold the distal non-adhesive anatomical structure (in which the anchor feature 130 is disposed) relative to the proximal non-adhesive anatomical structure from which the access and delivery device and system 100 was advanced into the distal non-adhesive anatomical structure. Additionally, the anchor feature 130 can prevent the advancement of other devices into the distal non-adhesive anatomical structure, such as to protect the distal tissue wall of the non-adhesive anatomical structure in which the anchor feature 130 is disposed. These and other aspects are described in further detail below with reference to FIGS. 3A-3D .

[0031] 1 and 2 , anchor member 122 of access and delivery device 120 is coupled to or otherwise extends from proximal portion 124 of access and delivery device 120. In some embodiments, distal tip 126 of access and delivery device 120 is thin and / or flexible and / or coated with a polymer coating or layer (to cushion the underlying material) or is a soft distal tip 126 shaped and / or configured to atraumatically contact tissue. For example, soft distal tip 126 is configured to easily bend upon contacting a tissue wall such that advancement of access and delivery device 120 against the distal tissue wall of a non-adherent anatomical structure into which access and delivery system 100 is advanced is atraumatically. In some embodiments, the soft distal tip 126 can be advanced distally once the tissue-piercing end 112 of the tissue-piercing element 110 penetrates the anatomical structure to protect the distal wall of the anatomical structure from the tissue-piercing end 112. Additionally, the soft distal tip 126 can atraumatically move the distal wall of the non-adhesive anatomical structure into which the implantable device 1010 is deployed out of the path of the implantable device delivery and deployment system 1000 (e.g., its tissue-piercing end).

[0032] During delivery (e.g., transluminal delivery through a patient's body), access and delivery device 120 remains within lumen 115 of tissue-piercing element 110, with anchor member 122 proximal to window 117 in an extended configuration generally aligned with proximal portion 124. Distal advancement of access and delivery device 120 relative to tissue-piercing element 110 aligns anchor member 122 with window 117. For example, distal advancement of access and delivery device 120 to extend soft distal tip 126 distal to tissue-piercing end 112 of tissue-piercing element 110 can align anchor member 122 with window 117, allowing anchor member 122 to form anchor feature 130. In some embodiments, as shown in FIG. 2 , the tissue-penetrating element 110 and the access and delivery device 120 are configured and dimensioned such that when the soft distal tip 126 is positioned distal to the tissue-penetrating end 112 of the tissue-penetrating element 110, the anchor member 122 is aligned with and extends through the window 117.

[0033] 3A-3D illustrate one example of how an access and delivery system 100 formed according to various principles of the present disclosure may be used to access a deployment site for and / or facilitate delivery of an implantable device 1010, such as with an implantable device delivery and deployment system 1000. In FIG. 3A , the distal end 111 of the tissue-piercing element 110 is shown already distally advanced into the distal non-adherent anatomical structure DS. More specifically, the tissue-piercing element 110 advances from within the proximal non-adherent anatomical structure PS, through its tissue wall W, distally through the proximal tissue wall PW of the distal non-adherent anatomical structure DS, and into the distal non-adherent anatomical structure DS. As can be appreciated, the tissue-piercing end 112 of the tissue-piercing element 110 may be sufficiently sharp to penetrate the walls of the proximal non-adherent anatomical structure PS and the distal non-adherent anatomical structure DS. The implantable device delivery and deployment system 1000 remains within the proximal non-adherent anatomical structure PS at this stage.

[0034] 3B , the distal end 121 of the access and delivery device 120 preferably extends distally from the distal end 111 of the tissue-piercing element 110 before the tissue-piercing end 112 contacts the distal tissue wall DW of the distal non-adhesive anatomical structure DS. Thus, the soft distal tip 126 extends distally beyond the tissue-piercing end 112 of the tissue-piercing element 110 to protect the distal tissue wall DW from the tissue-piercing end 112. Optionally, the soft distal tip 126 can extend the distal tissue wall DW away from the proximal tissue wall PW to create a larger space within the distal non-adhesive anatomical structure DS to accommodate the implantable device 1010. As also shown in FIG. 3B, distal advancement of the access and delivery device 120 aligns the anchor member 122 with the window 117 in the tissue-penetrating element 110, allowing the anchor member 122 to bend outward through the window 117 to form the anchor feature 130.

[0035] The anchor feature 130 may have sufficient strength and a size, shape, configuration, and / or dimensions to allow proximal retraction of the anchor feature 130 to proximally retract the proximal tissue wall PW, as shown in FIG. 3C . Proximal retraction of the access and delivery device and system 100 draws the distal non-adhesive anatomical structure DS proximally toward the proximal non-adhesive anatomical structure PS. The proximal tissue wall PW of the distal non-adhesive anatomical structure DS is thereby juxtaposed with the proximal non-adhesive anatomical structure PS, which can facilitate delivery of the implantable device 1010 through the walls of the proximal non-adhesive anatomical structure PS and the distal non-adhesive anatomical structure DS. Juxtaposition of the proximal non-adhesive anatomical structure PS and the distal non-adhesive anatomical structure DS can be beneficial in preventing fluid leakage from such structures (e.g., leakage of gastric juices from the stomach into the peritoneum).

[0036] Once the proximal non-adhesive anatomical structure PS and the distal non-adhesive anatomical structure DS are properly positioned relative to one another, the implantable device delivery and deployment system 1000 can be advanced distally from the proximal non-adhesive anatomical structure PS into the distal non-adhesive anatomical structure DS, as shown in FIG. 3D . As can be appreciated, the anchor feature 130 may obstruct or impede further distal advancement of the implantable device delivery and deployment system 1000, which would otherwise result in the distal end 1001 of the implantable device delivery and deployment system 1000 contacting the distal tissue wall DW of the distal non-adhesive anatomical structure DS. Such protective function of the anchor feature 130 may be particularly desirable when the implantable device delivery and deployment system 1000 includes a tissue-piercing element 1020, as shown in FIG. 3D and FIG. 1 .

[0037] As can be understood with further reference to FIG. 1 , the tissue-piercing element 1020 of the implantable device delivery and deployment system 1000 has a distal end 1021 with a tissue-piercing tip 1022 configured to contact tissue. The tissue-piercing tip 1022 may be sufficiently sharp to puncture tissue, and / or the tissue-piercing element 1022 may be a cauterizing tip that is supplied with energy by a wire 1024 coupled to the tissue-piercing element 1020 by a wire connection 1026. Once the tissue-piercing element 1020 is advanced to a selected deployment site (e.g., within the distal non-adhesive anatomical structure DS, between the proximal tissue wall PW and the distal tissue wall DW), the implantable device 1010 may be deployed. In the example embodiment of the implantable device delivery and deployment system 1000 shown in FIG. 1 , the implantable device 1010 is retained within the implantable device delivery and deployment system 1000 by a sheath 1030. The implantable device 1010 fits within a lumen 1035 defined in the sheath 1030 and is constrained therein in a compact delivery configuration capable of being delivered transluminally through the patient's body, such as in a manner known to those skilled in the art. Once the implantable device delivery and deployment system 1000 is located at the deployment site, the sheath 1030 may be retracted proximally to allow the implantable device 1010 to transition to an expanded, deployed configuration in various manners known to those skilled in the art. As can be understood with reference to FIG. 1 , the implantable device 1010 may be delivered within the implantable device delivery and deployment system 1000 on a shaft 1040 having a lumen 1045 defined within the shaft 1040 through which the access and delivery device and system 100 movably (e.g., translatably) extends.

[0038] In some embodiments, once the implantable device 1010 has been delivered and deployed, the access and delivery device and system 100 may be retracted proximally to cause the anchor member 122 to return into the lumen 115 of the tissue penetrating element 110 and allow proximal retraction of the access and delivery system 100. In some embodiments, the access and delivery system 100 is retracted into the lumen 1035 of the sheath 1030 of the implantable device delivery and deployment system 1000 for retraction and removal from the patient.

[0039] Various modifications may be made to access and delivery devices and systems formed in accordance with the various principles of the present disclosure without departing from the various principles of the present disclosure. For example, modifications may be to the tissue penetrating elements or the access and delivery devices, or both.

[0040] For example, as shown in FIGURES 4A and 4B, an exemplary embodiment of an access and delivery system 100' formed in accordance with various principles of the present disclosure may have a tissue-piercing element 110' without a fenestration formed therein. In such an embodiment, anchor member 122 of access and delivery device 120 is extended distally through lumen 115' of tissue-piercing element 110', extending beyond tissue-piercing tip 112' and exiting distal end 111' of tissue-piercing element 110', as shown in FIGURE 4B, allowing anchor member 122 to transition to an expanded configuration and form anchor feature 130. Various features of access and delivery device 120 may be identical to access and delivery device 120 described above with reference to FIGURES 1 and 2, are labeled with similar reference numbers, and reference is made to the above description thereof for brevity.

[0041] Additionally or alternatively, one or more features or elements of the access and delivery device may be modified. In the example embodiment of the access and delivery device and system 100″ shown in FIG. 5 , a modified access and delivery device 120′ is shown with the modified tissue penetrating element 110′ shown in FIGS. 4A and 4B . However, it will be understood that the modified access and delivery device 120′ may instead be used with the tissue penetrating element 110 shown in FIGS. 1 and 2 . The modified access and delivery device 120′ shown in FIG. 5 has a modified anchor member 122′ that is sized, shaped, configured, and / or dimensioned relative to the implantable device delivery and deployment system 1000 and advanced thereagainst to limit distal advancement of the implantable device delivery and deployment system 1000 against a distal tissue wall. In some embodiments, the depicted example of an embodiment of anchor feature 130′ may be configured to include a pocket 132′ sized, shaped, configured, and / or dimensioned to restrain or capture tissue-piercing element 1020 of implantable device delivery and deployment system 1000 so as to impede further distal advancement of tissue-piercing element 1020. The tissue-piercing end 1022 may thereby be prevented from contacting (and potentially damaging) the distal wall of the non-adherent anatomical structure into which implantable device delivery and deployment system 1000 is advanced. The modified access and delivery device 120′ may include a soft distal tip 126′ and proximal portion 124′ similar to the soft distal tip 126 and proximal portion 124 of access and delivery device 120 described above with reference to FIGS. 1 and 2 , and for brevity reference is made to the above description.

[0042] It should be understood by those skilled in the art that this description is merely a description of example illustrative embodiments and is not intended as limiting the broader aspects of the present disclosure. It will be understood that the various example embodiments described above may be arranged and operate in substantially the same or similar manner. Thus, for brevity and convenience, and without any intent to be limiting, common elements having common functionality will be designated with like reference characters (with or without a subsequent ') and reference will be made to previous descriptions of similar elements and operations.

[0043] All devices and methods described herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only ways of implementing these principles; they are merely examples and are not intended to limit the broader aspects of the present disclosure. Therefore, references to elements or structures or features in the drawings should be understood as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this disclosure. It will be apparent to those skilled in the art that variations can be applied to the disclosed devices, systems, and / or methods and / or to the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the present disclosure. It will be understood that various features described with respect to one embodiment can typically be applied to other embodiments, whether or not explicitly stated. The various features described below may be used alone or in any combination thereof. Accordingly, the present invention is not limited to only the embodiments specifically described herein, and all alternatives 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 devices, systems, and methods as described above may be appreciated by those skilled in the art.

[0044] Embodiments of the present disclosure may be used in conjunction with procedures for treating the gastrointestinal system or other anatomical systems, such as the abdominal cavity, digestive system, urinary tract, reproductive tract, respiratory system, cardiovascular system, and circulatory system. The medical devices described herein may be delivered with additional medical devices for navigating body lumens, including, for example, catheters, endoscopes, duodenoscopes, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, laparoscopes, and the like. The disclosed medical devices and systems may be inserted via different access points and approaches, for example, percutaneously, endoscopically, laparoscopically, or combinations thereof. In light of the above description, it will be understood that the devices, systems, and methods disclosed herein can be used to form one or more anastomoses and can be used in conjunction with basic endoscopic tools, catheters, laparoscopes, general surgical tools, and the like. For example, the implantable device delivery and deployment system described herein may be a catheter-based stent delivery device that can be used with an endoscope to form, for example, an anastomosis between two sections of the intestine. An endoscopic-based device can be used to create an anastomosis between the fundus pouch and a portion of the intestine, such as the jejunum. A combination of a laparoscopic-based device and a catheter device, as described herein, can also be used to create a single anastomosis.

[0045] The foregoing description is broadly applicable and has been presented for purposes of illustration and explanation and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present 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 are grouped into 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 has been 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 understand that the present disclosure can be used with many modifications, or modifications of the structure, arrangement, proportions, materials, components, and the like used in implementing the disclosure, that are particularly adapted to particular environments and operating requirements, without departing from the principles, spirit, or scope of the disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or changed, and sizes or dimensions of 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 specific order to achieve desirable results, or that all operations or actions or procedures should be performed. Additionally, other implementations are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the above, individual features of any embodiment may be used and claimed separately or in combination with features of that or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0046] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that function both conjunctively and disjunctively. Terms such as "a," "an," "the," "first," and "second" do not exclude a plurality. For example, the terms "a" or "an" entity, as used herein, refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally used in its sense to include "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected unless the context clearly dictates otherwise, and the conjunction "or" includes one or the other of the structures, components, features, etc. so connected, alone and in any combination and number, unless the context clearly dictates otherwise. All directional references (e.g., proximal, distal, upper, lower, above, below, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used for identification purposes only 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. References to connections (e.g., attached, coupled, connected, engaged, and connected) should be construed broadly and, unless otherwise indicated, can include intermediate members between and relative movement between a collection of elements. Therefore, connection references do not necessarily imply that two elements are directly connected and in fixed relationship to each other.Distinguishing references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0047] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises," "comprising," "includes," and "comprising" 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, they may be advantageously combined, and 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. An access and delivery device and system configured to access a deployment site across a proximal tissue wall of an anatomical structure, comprising: a tissue-piercing element having a distal end configured to penetrate a tissue wall; an access and delivery device having a proximal portion, an anchoring member, and a distal tip; Equipped with The anchor member is formed of a flexible material different from the material of at least the proximal portion of the flexible elongate element, the flexible material being configured to bend laterally relative to the tissue-penetrating element to form an anchor feature of the system.

2. The system of claim 1 , wherein the anchor member is formed from a shape memory material.

3. 3. The system of claim 1 or 2, wherein the flexible material of the anchor member has sufficient strength to maintain a bent configuration transversely relative to the tissue-penetrating element when pulled proximally against the proximal tissue wall through which the system extends.

4. the distal end of the tissue-piercing element is sharp to pierce tissue; 4. The system of claim 1, wherein the distal tip of the flexible elongate element is extendable distally beyond the distal end of the tissue-piercing element and is soft to atraumatically engage and protect a tissue wall from the distal end of the tissue-piercing element.

5. The system of claim 4 , wherein the tissue-piercing element has a window formed therethrough, and the anchor member is extendable through the window to form the anchor feature.

6. 6. The system of claim 5, wherein the distal end of the tissue-penetrating element and the window are spaced apart from one another, and the distal tip of the flexible elongate element and the anchor member are spaced apart from one another such that when the anchor member extends from the window, the distal tip extends distally beyond the tissue-penetrating distal end.

7. The system of claim 1 , wherein the distal tip of the flexible elongate element is soft to atraumatically engage and atraumatically press against a tissue wall.

8. 1. A system for delivering an implantable device to a deployment site, comprising:

1. An access and delivery system comprising: a tissue-piercing element having a distal end configured to penetrate a tissue wall; an access and delivery device having a proximal portion, an anchor member configured to flex outwardly laterally relative to said tissue-piercing element, and a soft distal tip capable of atraumatically engaging tissue; an access and delivery system comprising:

1. An implantable device delivery and deployment system comprising: a tissue-penetrating element; Implantable devices and an implantable device delivery and deployment system, Equipped with the anchor member is configured to block distal advancement of the tissue-penetrating element of the implantable device delivery and deployment system; The soft distal tip is configured to block distal advancement of the tissue-piercing element of the access and delivery system.

9. The system of claim 8 , wherein the soft distal tip is configured to atraumatically push a tissue wall distally to create space for the implantable device at the deployment site.

10. the distal end of the tissue-piercing element is sharp to pierce tissue; 10. The system of claim 9, wherein the distal tip of the access and delivery device is extendable distally of the distal end of the tissue-piercing element and is soft to atraumatically engage and protect a tissue wall from the distal end of the tissue-piercing element.

11. 11. The system of claim 8, wherein the anchor member has sufficient strength to maintain a transversely bent configuration relative to the tissue penetrating element of the access and delivery system when pulled proximally against a proximal tissue wall through which the system extends.

12. 12. The system of claim 8, wherein the anchor member has sufficient strength to maintain a bent configuration laterally relative to the tissue-penetrating element of the implantable device delivery and deployment system as the tissue-penetrating element of the implantable device delivery and deployment system is advanced toward and relative to the anchor member, thereby preventing the tissue-penetrating element of the implantable device delivery and deployment system from advancing distally toward the soft distal tip.

13. The system of any one of claims 8 to 12, wherein the tissue-piercing element of the implantable device delivery and deployment system has a tissue-piercing tip configured to pierce tissue.

14. 14. The system of claim 8, wherein the anchor member is formed of a flexible material different from the material of at least the proximal portion of the access and delivery device, the flexible material being configured to bend laterally relative to the tissue penetrating element to form an anchor feature of the access and delivery system.

15. The system of any one of claims 8 to 14, wherein the anchor member is formed from a shape memory material.

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