The present disclosure relates generally to the field of implantable medical devices. In particular, the present disclosure relates to implantable medical devices, systems, and methods for joining anatomical structures, such as ends of body lumens, such as to form an anastomosis. More particularly, the devices, systems, and methods of the present disclosure may be used transluminally without requiring open surgical procedures such as those requiring incisions to access the internal anatomical structures to be joined.
Various tissue dissection or resection procedures are known for cutting and/or removing anatomical tissue from a target area within the body, such as to treat various pathologies. Tissue dissection procedures typically involve cutting tissue, and tissue resection procedures typically involve cutting and removing tissue and/or a part of an anatomical structure (e.g., an organ, tissue wall, body lumen, etc.). Full-thickness resection of tissue, through multiple layers of a tissue wall, may be performed, such as to remove harmful growths or lesions. Dissections and resections of body lumens (with generally tubular tissue walls), such as tissue of a gastrointestinal tract, may be particularly challenging because the integrity of the lumen may be important to prevent materials from passing through the lumen wall and out of the lumen rather than through and along the longitudinal extent of the lumen.
Open surgery (involving cutting open the patient's body to gain access into the patient's body and internal anatomical structures) or laparoscopy (typically involving smaller incisions to gain access into the patient's body and internal anatomical structures) are the most common methods for performing tissue resection. Such methods involve longer recovery times than endoscopic methods which do not involve incisions, but which, instead, typically access the internal anatomy through a natural orifice and advancing equipment, tools, devices, etc., transluminally to the target area. However, full-thickness endoscopic resections of target tissue (e.g., tissue comprising the deleterious growth or lesion) present various other challenges, such as with visualizing adjacent anatomy during the procedure.
Accordingly, there remains an ongoing need for endoscopic devices, systems, and methods for dissecting and/or resecting tissue, such as dissecting and/or resecting body lumens. There remains an associated ongoing need for endoscopic devices, systems, and methods for creating an anastomosis between resected sections of a body lumen.
This Summary is provided to introduce, in simplified form, a selection of concepts described in further 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. One of skill in the art will understand that each of the various aspects and features of the present disclosure may advantageously be used separately in some instances, or in combination with other aspects and features of the disclosure in other instances, whether or not described in this Summary. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, or the like in this Summary.
In accordance with various principles of the present disclosure, an implantable medical device system configured to form an anastomosis across cut ends of a body lumen includes a first tubular implantable medical device, a second tubular implantable medical device, and a connector configured to couple the first tubular implantable medical device and the second tubular implantable medical device together. In some aspects, the first tubular implantable medical device and the second tubular implantable medical device include tissue-engagement features configured to facilitate coupling of the first and second tubular implantable medical devices with respect to a body lumen, and a support configured to facilitate coupling of the first and second tubular implantable devices together.
In some embodiments, the tissue-engagement features are provided at a tissue-engaging region of each of the first and second implantable medical devices; and the support includes a support at a device-engaging region of each of the first and second implantable medical devices.
In some embodiments, the tissue-engagement features comprise apertures.
In some embodiments, the tissue-engagement features are configured to allow at least one of a tissue connector or tissue to extend therethrough to anchor the first and second implantable medical devices with respect to the body lumen.
In some embodiments, the connector is a tubular connector formed separately from the first and second implantable medical devices, and has a first end engageable with the support of the first implantable medical device and a second end engageable with the support of the second implantable medical device to couple the first and second implantable medical devices together. In some embodiments, the tubular connector couples the first and second implantable medical devices together with supports of the first and second implantable medical device spaced apart from each other. In some embodiments, the tubular connector is coated to prevent passage of materials through the wall thereof. In some embodiments, the tubular connector couples the first and second implantable medical devices together with supports of the first and second implantable medical device abuttingly engaging each other.
In some embodiments, the connector is an elongated tether-like connector formed separately from the first and second implantable medical devices and configured to be secured to the supports of the first and second implantable medical devices to couple the first and second implantable medical devices together in abutting engagement.
In some embodiments, the connector comprises interengaging features on the supports of the first and second implantable medical device configured to interengage each other to couple the first and second implantable medical devices together.
In some embodiments, the system further comprises a tether coupling the first and second implantable medical devices together after the body lumen to which the first and second implantable medical devices are coupled has been cut between the first and second implantable medical devices.
In accordance with various principles of the present disclosure, an implantable medical device system includes a first implantable medical device; a second implantable medical device; and a connector configured to couple the first implantable medical device and the second implantable medical device together. In some aspects, the first implantable medical device and the second implantable medical device each include tissue-engagement features configured to facilitate coupling of the first and second implantable medical devices with tissue; and a support configured to facilitate engagement of the first and second implantable devices to couple the first and second implantable medical devices together. In some aspects, the connector establishes an anastomosis through the first implantable medical device and the second implantable medical device preventing flow of materials in a direction through walls of the first and second implantable medical devices.
In some embodiments, the tissue-engagement features comprise apertures configured to allow at least one of a tissue connector or tissue to extend therethrough.
In some embodiments, the connector is a tubular connector formed separately from the first and second implantable medical devices, and has a first end engageable with the support of the first implantable medical device and a second end engageable with the support of the second implantable medical device to couple the first and second implantable medical devices together. In some embodiments, the tubular connector is a stent having a first end engageable with the support of the first implantable medical device and a second end engageable with the support of the second implantable medical device.
In accordance with various principles of the present disclosure, a method of forming an anastomosis after a colostomy includes implanting a first implantable medical device within a colon at a location distal to target tissue to be excised; implanting a second implantable medical device within a colon at location proximal to target tissue to be excised; excising the target tissue; and joining device-engaging regions of the first and second implantable medical devices with a connector.
In some aspects, implanting a first implantable medical device and implanting a second implantable medical device comprise extending at least one of tissue of the colon or a tissue connector through tissue-engagement features in each of the first implantable medical device and the second implantable medical device to anchor the first and second implantable medical devices with respect to the colon.
In some aspects, joining device-engaging regions of the first and second implantable medical devices comprises extending a tubular stent between the first and second implantable medical devices to form an anastomosis therebetween.
In some aspects, joining device-engaging regions of the first and second implantable medical devices comprises bringing the first and second devices into abutting engagement and coupling the first and second implantable medical devices together in abutting engagement to form an anastomosis through the first and second implantable medical devices.
In some aspects, the method further includes coupling a portion of the colon distal to the first implantable medical device with a portion of the colon proximal to the second implantable medical device with a tether before joining the first and second implantable medical devices together.
These and other features and advantages of the present disclosure, will be readily apparent from the following detailed description, the scope of the claimed invention being set out in the appended claims. While the following disclosure is presented in terms of aspects or embodiments, it should be appreciated that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.
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 purposes of illustration only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, devices may be enlarged so that detail is discernable, but is intended to be scaled down in relation to, e.g., fit within a working channel of a delivery catheter or endoscope. In the various figures, identical or nearly identical or equivalent elements are typically represented by the same reference characters, and similar elements are typically designated with similar reference numbers followed by ‘, or ‘′, with redundant description omitted for the sake of brevity. For purposes of clarity and simplicity, not every element is labeled in every figure, nor is every element of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure.
The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as follows:
The following detailed description should be read with reference to the drawings, which depict illustrative embodiments. It is to be understood that the disclosure is not limited to the particular embodiments described, as such may vary. All apparatuses and systems and methods discussed herein are examples of apparatuses and/or systems and/or methods implemented in accordance with one or more principles of this disclosure. Each example of an embodiment is provided by way of explanation and is not the only way to implement these principles but are merely examples. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. In fact, 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 instance, features illustrated or described as part of one embodiment can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.
It will be appreciated that the present disclosure is set forth in various levels of detail in this application. In certain instances, details that are not necessary for one of ordinary skill in the art to understand the disclosure, or that render other details difficult to perceive 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 defined otherwise, technical terms used herein are to be understood as commonly understood by one of ordinary skill in the art to which the 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.
As used herein, “proximal” refers to the direction or location closest to the user (medical professional or clinician or technician or operator or physician, etc., such terms being used interchangeably herein without intent to limit, and including automated controller systems or otherwise), etc., such as when using a device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device, and “distal” refers to the direction or location furthest from the user, such as when using the device (e.g., introducing the device into a patient, or during implantation, positioning, or delivery), and/or closest to a delivery device. “Longitudinal” means extending along the longer or larger dimension of an element. A “longitudinal axis” extends along the longitudinal extent of an element, though is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and “axial” generally refers to along the longitudinal axis. However, it will be appreciated that reference 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 movements along a longitudinal axis or central axis of the referenced elements. “Central” means at least generally bisecting a center point and/or generally equidistant from a periphery or boundary, and a “central axis” means, with respect to an opening, a line that at least generally bisects a center point of the opening, extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a strut, a channel, a cavity, or a bore. As used herein, a “lumen” or “channel” or “bore” or “passage” is not limited to a circular cross-section. As used herein, a “free end” of an element is a terminal end at which such element does not extend beyond. It will be appreciated that terms such as at or on or adjacent or along an end may be used interchangeably herein without intent to limit unless otherwise stated, and are intended to indicate a general relative spatial relation rather than a precisely limited location. Finally, reference to “at” a location or site is intended to include at and/or about the vicinity of (e.g., along, adjacent, etc.) such location or site. As such, reference to “at” a target tissue site is intended to include tissue at and about the vicinity of (e.g., along, adjacent, etc.) the target tissue, and is not limited to just target tissue. References to a target tissue site, deployment site, target area, etc., may be made interchangeably herein without intent to limit.
In accordance with various principles of the present disclosure, an implantable medical device system includes a first implantable medical device configured to be coupled to a body lumen and a second implantable medical device configured to be coupled to a body lumen. Reference is made to a body lumen for the sake of convenience and without intent to limit, and such term is to be understood herein as referring to an anatomical structure (e.g., tissue wall) forming a passage therethrough. Moreover, it will be appreciated that terms such as deploy, implant, anchor, attach, associate, secure, couple, join, engage, etc., (and various grammatical forms thereof), may be used interchangeably herein without intent to limit. The first and second implantable medical devices of the implantable medical device system are deployed within the body lumen and/or around the body lumen. However, other relative positions of the devices and body lumen are within the scope and spirit of the present disclosure as may be appreciated by one of ordinary skill in the art.
In some embodiments, the implantable medical devices are implanted while the body lumen intact. For instance, one implantable medical device of the implantable medical device system may be deployed and implanted distal to the target area of tissue to be treated and/or excised, and another implantable medical device of the implantable medical device system may be deployed and implanted proximal to the target area of tissue to be treated and/or excised. The order of deployment is not critical, though it may be simpler to deploy the distal of the implantable medical devices before the proximal of the implantable medical device. If implanted together in an intact body lumen, the implantable medical devices may be implanted spaced apart from each other, and the body lumen may then be cut between the respective deployment sites of the first implantable medical device and the second implantable medical device. Tissue of the body lumen, such as between the deployment sites of the first and second implantable medical devices, may then be removed (e.g., if diseased, damaged, malformed, etc.). The separated cut ends of the body lumen are then joined together via the implantable medical devices and system of the present disclosure. Use of an implantable medical device system formed in accordance with various principles of the present disclosure may thereby reestablish flow of materials through the disrupted body passage by facilitating rejoining of the ends of the body lumen, such as to form an anastomosis. It will be appreciated that in some embodiments, a system and associated devices as disclosed herein may be coupled with already separate ends of tubular structures in a patient's body. Reference may be made herein interchangeably to terms such as cut, dissect, resect, excise, incise, remove, etc., and other grammatical forms thereto, without intent to limit.
The use of separately formed implantable medical devices in some embodiments may be beneficial, such as to allow independent delivery of the devices, independent deployment of the devices, independent adjustability of the devices and the overall system, increased adjustability of the overall system, reduction in material needed to span across an area to be joined by the devices, etc., as will become apparent in light of the following disclosure.
In accordance with various principles of the present disclosure, at least a portion of the implantable medical device system, such as at least a portion of at least one of, or both of, the implantable medical devices has an attachment feature configured to facilitate attachment to the tissue wall of the deployment site (e.g., a body lumen wall). For instance, at least a portion of the implantable medical device system is configured to be directly engaged with tissue at the deployment site (e.g., having a portion clipped, anchored, penetrating, or otherwise engaging tissue at the deployment site to maintain the implantable medical device system positioned with respect to the deployment site), and/or to allow a separate coupler (e.g., tether, wire, suture, string, staple, bonding agent, etc.) to be engaged with both the implantable medical device system and tissue at the deployment site, and/or to allow tissue ingrowth with respect to the implantable medical device system.
Moreover, in accordance with various principles of the present disclosure, the first implantable medical device and the second implantable medical device of an implantable medical device system are configured to be coupled with each other along at least a portion thereof. For instance, in some embodiments, each of the first implantable medical device and the second implantable medical device is configured to be engaged with a connector which extends between and couples the first and second implantable medical devices. In some embodiments, the implantable medical devices engage each other, either with a separately-formed connector therebetween, or directly (without the use of a connector, and/or with a connector formed integrally with and as a part of one or both of the implantable medical devices). For instance, in some embodiments, the first and second implantable medical devices are configured to directly engage each other generally to abut each other and to be coupled to connect body lumens in which each implantable medical device is respectively deployed.
Various embodiments of implantable medical devices, an implantable medical device system, and methods associated therewith will now be described with reference to examples illustrated in the accompanying drawings. Reference in this specification to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. indicates that one or more particular features, structures, concepts, and/or characteristics in accordance with principles of the present disclosure may be included in connection with the embodiment. However, such references do not necessarily mean that all embodiments include the particular features, structures, concepts, and/or characteristics, 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 characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiment are within the scope of the present disclosure. Moreover, references to “one embodiment,” “an embodiment,” “some embodiments”, “other embodiments”, etc. in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. It should further be understood that various features, structures, concepts, and/or characteristics of disclosed embodiments are independent of and separate from one another, and may be used or present individually or in various combinations with one another to create alternative embodiments which are considered part of the present disclosure. Therefore, the present disclosure is not limited to only the embodiments specifically described herein, as it would be too cumbersome to describe all of the numerous possible combinations and subcombinations of features, structures, concepts, and/or characteristics, and the examples of embodiments disclosed herein are not intended as limiting the broader aspects of the present disclosure. The following description is of illustrative examples of embodiments only, and is not intended as limiting the broader aspects of the present disclosure.
It will be appreciated that common features in the accompanying drawings are identified by common reference elements and, for the sake of brevity and convenience, and without intent to limit, the descriptions of the common features are generally not repeated. For purposes of clarity, not all components having the same reference number are numbered. Moreover, a group of similar elements may be indicated by a number and letter, and reference may be made generally to one or such elements or such elements as a group by the number alone (without including the letters associated with each similar element). For the sake of simplicity, certain features in one embodiment may be used across different embodiments and are not necessarily individually labeled when appearing in different embodiments.
Turning now to the drawings, an example of human anatomical structure at which an anastomosis may be formed in accordance with various principles of the present disclosure is illustrated schematically in
The implantable medical device system 1000 illustrated in
An example of an embodiment of an implantable medical device 100 of an implantable medical device system 1000 formed in accordance with various principles of the present disclosure is illustrated in further detail in
The implantable medical device 100 may be formed as an expandable scaffold or stent formed of members (e.g., struts, wires, strands, filaments, etc.) which are braided, interengaged, intertwined, interwoven, knitted, knotted, looped (e.g., bobbinet-style), weaved, woven, wrapped, or the like to form a tubular structure. Additionally or alternatively, the implantable medical device 100 may be formed by cutting (e.g., by laser-cutting) a tubular structure (e.g., an, optionally monolithic, cylindrical tubular member) into an expandable configuration, the cuts forming members such as strut members. An implantable medical device of an implantable medical device system 1000 of the present disclosure may be a self-expanding device such as known or heretofore known to those of ordinary skill in the art. For instance, the implantable medical device may be formed of shape-memory or heat-formable material (e.g., Nitinol or Elgiloy® or shape memory polymers) so that the implantable medical device returns to a pre-shaped expanded configuration from a collapsed delivery configuration upon advancement from a delivery element and/or withdrawal of a delivery sheath which maintains the implantable medical device in a delivery configuration therein.
An example of an embodiment of an implantable medical device 100 is illustrated in further detail in
In the example of an embodiment illustrated in
In the example of an embodiment illustrated in
It will be appreciated that a support 120 of a device-engaging region 103 of an implantable medical device 100 formed in accordance with various principles of the present disclosure may be in any of a variety of configurations, such as to accommodate various manners of connecting two implantable medical devices 100 with the assistance of the support 120. For instance, various configurations of supports 120 are illustrated in the detail views
Various examples of manners of implanting implantable medical devices 100 within respective portions of body lumens, such as with tissue-engagement features 110 as described above, and joining body lumens with the assistance of the implantable medical devices 100, such as with a support 120 as described above, may be appreciated with reference to
In the example of an embodiment illustrated in
The tissue connector 210 may be any suitable, preferably biocompatible, element known to those of ordinary skill in the art for coupling tissue to another element (tissue or otherwise), such as a suture, a thread, a wire, a tether, a filament, a band, a staple, etc., typically at least somewhat elongated and flexible. For instance, in the example of an embodiment illustrated in
In the example of an embodiment illustrated in
In an embodiment in which separate implantable medical devices 100 are deployed in a common body lumen, one of the implantable medical devices 100 may be deployed first, and then the second implantable medical device 100 may be deployed. For instance, a first distal implantable medical device 100 may be deployed, and then a second proximal implantable medical device 100 may be deployed. Each implantable medical device 100 may be anchored with respect to the tissue upon deployment or once both implantable medical devices 100 have been deployed. Once both implantable medical devices 100 have been deployed and implanted in a common body lumen, spaced apart from each other, such as illustrated in
In the example of an embodiment illustrated in
The length of the tubular connector 420 may be selected based on the distance between the cut ends ED, EP to span the distance between the cut ends ED, EP and to form a passage or lumen therebetween. As may be appreciated with reference to
It will be appreciated that in some embodiments, a tubular connector need not span across a gap between cut ends ED, EP of a body lumen. For instance, in the example of an embodiment illustrated in
In some aspects of the present disclosure, the implantable medical devices 100 are coupled with a connector other than a stent such as illustrated in
In some aspects of the present disclosure, the implantable medical devices 100 are coupled directly to each other without the need of a separate connector element. For instance, in the example of an embodiment illustrated in
It will be appreciated that reference to a body passage includes naturally-existing passages (e.g., the colon) as well as medically-created passages (e.g., a passage created with the use of a medical instrument, and not existing without medical intervention) or otherwise.
It is to be understood by one of ordinary skill in the art that the present discussion is a description of illustrative examples of embodiments only, and is not intended as limiting the broader aspects of the present disclosure.
All apparatuses and methods discussed herein are examples of apparatuses and/or methods implemented in accordance with one or more principles of this disclosure. These examples are not the only way to implement these principles but are merely examples, not intended as limiting the broader aspects of the present disclosure. Thus, references to elements or structures or features in the drawings must be appreciated as references to examples of embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures, or features illustrated. Other examples of manners of implementing the disclosed principles will occur to a person of ordinary skill in the art upon reading this disclosure. It should be apparent to those of ordinary skill 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 method described herein without departing from the concept, spirit, and scope of the disclosure. It will be appreciated that various features described with respect to one embodiment typically may be applied to another embodiment, whether or not explicitly indicated. The various features hereinafter described may be used singly or in any combination thereof. Therefore, the present invention is not limited to only the embodiments specifically described herein, and all substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the disclosure as defined by the appended claims.
Although 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 appreciated 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, and the like.
Various further benefits of the various aspects, features, components, and structures of devices, systems, and methods such as described above, in addition to those discussed above, may be appreciated by those of ordinary skill in the art.
The foregoing discussion has broad application and has been presented for purposes of illustration and description 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 embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be clear to those skilled in the art that 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 disclosure are 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 the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be appreciated that the various separate features of the present subject matter need not all be present in order to achieve at least some of the desired characteristics and/or benefits of the present subject matter or such individual features. One skilled in the art will appreciate that the disclosure may be used with many modifications or modifications of structure, arrangement, proportions, materials, components, and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied. Similarly, while operations or actions or procedures are described in a particular order, this should not be understood as requiring such particular order, or that all operations or actions or procedures are to be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the foregoing description or particular embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and can be claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims, and not limited to the foregoing description.
In the foregoing description and the following claims, the following will be appreciated. The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a”, “an”, “the”, “first”, “second”, etc., do not preclude a plurality. For example, the term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, 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 employed 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, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the others of the structures, components, features, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and/or the like) are only used for identification purposes to aid the reader's understanding of the present disclosure, and/or serve to distinguish regions of the associated elements from one another, and do not limit the associated element, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, engaged, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.
The following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms “comprises”, “comprising”, “includes”, and “including” do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.
This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63/401,778, filed Aug. 29, 2022, the entire disclosure of which is hereby incorporated by reference herein for all purposes.
Number | Date | Country | |
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63401778 | Aug 2022 | US |