Devices, systems, and methods for tunneling between organizational layers

Abstract

An assembly and / or system is disclosed having a cutting device configured to cut tissue and an inflatable device configured to be inserted into the cut tissue to further separate the cut tissue. The inflatable device may be wedge-shaped to separate the cut tissue when inserted into the cutting portion. The inflatable device is inflatable to separate the tissue to a medically required extent and is otherwise adjustable. For example, the inflatable device may be moved axially relative to the cutting device and / or may be covered or not covered to adjust the exposed inflated length of the inflatable device and / or may include two or more separate inflatable elements. Thus, the inflatable device may be used to achieve blunt tissue dissection after an initial cut has been made in the tissue with a sharp instrument.

Description

Technical Field

[0001] The present disclosure generally relates to the field of medical devices for accessing spaces within anatomical structures. In particular, the present disclosure relates to medical devices, systems, and methods for cutting or tunneling within and / or between tissue layers of an anatomical structure.

Background Art

[0002] There are various devices, assemblies, systems, methods, and techniques for cutting, incising, excising, and removing anatomical structures (e.g., biological tissues including lesions). The configuration of cutting devices (which may include blades, needles, lasers, or other structures capable of cutting anatomical structures) may be selected based on the specific procedure being performed. Procedures may be performed by open surgery (accessing the inside of the patient's body by making an incision) or minimally invasive surgery (e.g., percutaneous, laparosopically, endoscopically, etc.). One endoscopic procedure is third-space endoscopy (also known as submucosal endoscopy), which allows access to deeper layers of tissue within the body (e.g., the gastrointestinal (GI) tract) by tunneling into tissue, such as between layers of structurally differentiated tissue. For example, in the GI system, tunneling may be performed in the submucosal space using an endoscope without compromising the integrity of the covering mucosa. Typically, a fluid (e.g., saline solution) is injected into the treatment site to elevate / lift the tissue (creating a "bleb"), facilitating tissue cutting with a knife or similar instrument. For example, a bulging agent may be injected into the submucosa to separate the mucosal layer from the muscular layer. A cutting knife may then be used to cut open the submucosal tissue. During tunneling, a medical scope (e.g., an endoscope) may have a tapered distal cap attached to the distal end of the scope to help pass the scope through to the tissue at the target site. Blunt tissue cutting may be performed using mechanical force to separate the tissue layers. In some embodiments, the scope cap may provide a form of blunt tissue cutting as the scope tapers through the tissue. However, cutting instruments such as electrosurgical units are typically used primarily to form tunnels through tissue in third-space endoscopic procedures. Typically, cutting instruments are used to make multiple small cuts, usually sequentially, to gradually create the desired separation of tissue, for example, to reduce the risk of creating extremely large cuts in the tissue. Safer and more efficient tunneling devices, systems, and methods would be welcome in this field. This improvement may be useful in addressing these and other considerations. [Overview of the project]

[0003] This "Summary of the Invention" is provided in a simplified form to introduce an excerpt of the concept, which will be described in more detail in the following "Modes for Carrying Out the Invention." This "Summary of the Invention" is not intended to necessarily identify the main or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter. Those skilled in the art will understand that, whether or not they are described in this "Summary of the Invention," each of the various aspects and features of this disclosure can be used, advantageously, separately in some examples, or in combination with other aspects and features of this disclosure in other examples. The inclusion or exclusion of elements, components, etc., in this "Summary of the Invention" is not intended to limit the scope of the claimed subject matter.

[0004] According to various principles of this disclosure, a tissue tunneling system includes a control handle at the proximal end of the system, an elongated delivery member extending distally from the control handle, a cutting device operably associated with the elongated delivery member for delivery at the distal end of the tissue tunneling system, and an inflatable device operably associated with the distal end of the tissue tunneling system.

[0005] In some embodiments, the inflatable device is operably associated with the distal end of a tissue tunneling system delivered to a target site proximal to the cutting device. In some embodiments, the inflatable device is axially movable relative to the cutting device.

[0006] In some embodiments, the inflatable device is operably associated with an elongated tubular member that is axially shiftable relative to an elongated delivery member. In some embodiments, the elongated tubular member defines a lumen through which the elongated tubular member passes, which is in fluid communication with the inflatable device, and delivers an expansion medium to the inflatable device to selectively expand it. In some embodiments, the elongated tubular member defines a lumen through which the elongated tubular member passes, and the elongated delivery member is insertable and axially translatable through the lumen of the elongated tubular member, moving the cutting device and the inflatable device relative to each other.

[0007] In some embodiments, in addition to being inflatable, the configuration of the inflatable device is adjustable. In some embodiments, the system further includes a sheath defining a lumen through which an inflatable device passes, the lumen being sized to accommodate an inflatable device, and the sheath being advanceable and retractable relative to the inflatable device in order to extend over or expose the inflatable device.

[0008] In some embodiments, the inflatable device includes two or more inflatable elements. In some embodiments, the control handle includes a first lumen for injecting fluid through a defined lumen via a cutting device, and a second lumen for injecting an expansion fluid into an inflatable device.

[0009] According to various principles of this disclosure, a tissue tunneling assembly includes a cutting device located at the distal end of the tissue tunneling assembly and an inflatable device located proximal to the cutting device.

[0010] In some embodiments, the inflatable device is axially movable relative to the cutting device. In some embodiments, the assembly further includes a sheath having a lumen through which it passes. In some embodiments, the sheath is axially movable relative to an inflatable device, and the inflatable device and lumen are sized such that the inflatable device selectively fits completely or partially into the lumen, partially extends and expands outside the lumen, or fully extends and expands outside the lumen.

[0011] In some embodiments, the inflatable device comprises two or more separate and independent inflatable elements. In some embodiments, the cutting device is an electrosurgical unit.

[0012] According to various principles of this disclosure, a method of tunneling into tissue includes advancing a tissue tunneling assembly having a cutting device to a target site, cutting the tissue with the cutting device, and further advancing the tissue tunneling assembly toward the cut tissue, thereby advancing the inflatable device of the tissue tunneling assembly into the cut tissue to further separate the cut tissue.

[0013] In some embodiments, the method further includes inflating an inflatable device to further separate the severed tissue. In some embodiments, the inflatable device is wedge-shaped, and by advancing the inflatable device further into the cut tissue, the tissue is separated in a wedge shape along the cut formed by the cutting device.

[0014] In some embodiments, the method further includes moving the inflatable device axially relative to the cutting device. In some embodiments, the method further includes selectively housing an inflatable device within a sheath and / or exposing the inflatable device from within the lumen of the sheath in order to adjust the expansion length of the inflatable device.

[0015] These features and advantages of the present disclosure, as well as other features and advantages, will be readily apparent from the following detailed description, and the claimed scope of the invention is set forth in the appended claims. The following disclosure is presented in terms of aspects or embodiments, but it should be understood that each aspect may be claimed separately or in combination with the aspects and features of its embodiment or any other embodiment.

[0016] Non-limiting embodiments of this disclosure are described by reference to the accompanying drawings, which are schematic and not intended to be shown to exact scale. The accompanying drawings are provided for illustrative purposes only, and dimensions, locations, order, and relative sizes reflected in the drawings may be modified. For example, devices may be enlarged to make details identifiable, but are intended to be scaled down in relation to, for example, to fit within the working channel of a delivery catheter or endoscope. In these drawings, identical, nearly identical, or equivalent elements are typically represented by the same reference numeral, similar elements are typically designated by similar reference numerals differing by hundreds, and redundant descriptions are omitted. For the purposes of clarity and simplification, not all elements are labeled in all drawings, and not all elements of each embodiment are shown where not illustration is necessary to enable those skilled in the art to understand this disclosure.

[0017] A more detailed explanation will be better understood in conjunction with the following attached drawings, where similar reference numerals represent similar elements. [Brief explanation of the drawing]

[0018] [Figure 1] This is a front view showing a tissue tunneling system formed according to an aspect of this disclosure. [Figure 1A] This is a front view showing a detailed area 1A of Figure 1. [Figure 1B] This is a perspective view showing a detailed area 1B in Figure 1A. [Figure 1C]It is a front view showing an alternative embodiment along the detailed area 1A of FIG. 1. [Figure 2] It is a front view showing a tissue tunneling system formed according to an aspect of the present disclosure, having an inflatable device movable with respect to a cutting device. [Figure 3] It is a front view showing a tissue tunneling system formed according to an aspect of the present disclosure, having an adjustable inflatable device. [Figure 3A] It is a diagram showing various examples of the configuration of the inflatable device in the detailed area 3 of FIG. 3. [Figure 3B] It is a diagram showing various examples of the configuration of the inflatable device in the detailed area 3 of FIG. 3. [Figure 3C] It is a diagram showing various examples of the configuration of the inflatable device in the detailed area 3 of FIG. 3. [Figure 3D] It is a diagram showing any mechanism configured to hold a selected configuration of the inflatable device. [Figure 4] It is a front view showing a tissue tunneling system formed according to an aspect of the present disclosure, having a multi-element inflatable device. [Figure 4A] It is a diagram showing an example of the configuration of the inflatable device in the detailed area 4 of FIG. 4. [Figure 4B] It is a diagram showing another example of the configuration of the inflatable device in the detailed area 4 of FIG. 4. [Figure 5] It is a diagram showing an example of an embodiment of an alternative configuration of the inflatable device that can be provided in the detailed area 1A of FIG. 1. [Figure 6A] It is a diagram showing another example of an embodiment of an alternative configuration of the inflatable device that can be provided in the detailed area 得る 1A of FIG. 1. [Figure 6B] It is an end view showing an example of an embodiment of the inflatable device shown in FIG. 6A.

Mode for Carrying Out the Invention

[0019] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that this disclosure is not limited to the specific embodiments described and is therefore subject to change. All devices, systems, and methods discussed herein are embodiments of devices, systems, and / or methods implemented in accordance with one or more principles of this disclosure. Each embodiment is provided for illustrative purposes only and is merely an example, not the only way to implement these principles. Therefore, references to elements, structures, or features in the drawings should be understood as references to embodiments of the disclosure and not as limiting the disclosure to any specific element, structure, or feature shown. Those skilled in the art will, upon reading this disclosure, be able to recall other examples of ways to implement the disclosed principles. Indeed, those skilled in the art will see that various modifications and variations can be made in this disclosure without departing from the scope or spirit of the subject matter. For example, further embodiments can be obtained by using features illustrated or described as part of one embodiment in conjunction with another embodiment. Therefore, this subject matter is intended to encompass such modifications and variations that fall within the scope of the attached claims and their equivalents.

[0020] In this application, it will be understood that the disclosure is described in detail at various levels. In certain examples, details that are not essential for a person skilled in the art to understand the disclosure, or details that would make it difficult to recognize other details, may be omitted. The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit them beyond the scope of the appended claims. Unless otherwise defined, the technical terms used herein should be understood as commonly understood by a person skilled in the art to which the disclosure belongs. All devices and / or methods disclosed and claimed herein can be fabricated and performed based on the disclosure without any unnecessary experimentation.

[0021] As used herein, “proximal” means the direction or location closest to the user (such as a medical professional, clinician, technician, surgeon, or physician, and these terms are used interchangeably herein without limitation, including automated controller systems, etc.) and / or the direction or location closest to the delivery device when using the device (e.g., when introducing the device into a patient's body, or during implantation, positioning, or delivery); “distal” means the direction or location furthest from the user and / or the direction or location closest to the delivery device when using the device (e.g., when introducing the device into a patient's body, or during implantation, positioning, or delivery); “longitudinal” means extending along the longer or greater dimension of an element; “longitudinal axis” means extending along the longitudinal range of an element, but not necessarily straight, and not necessarily maintaining a fixed configuration if the element is bent or curved; “axial” generally means along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement relating to the above-described system or its elements do not need to be strictly limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the element being referred to. "Center" means at least substantially intersecting the center point and / or being substantially equidistant from the periphery or boundary; "central axis" means, with respect to an opening, a line that at least substantially intersects the center point of the opening and extends longitudinally along the length of the opening if the opening includes, for example, a tubular element, channel, cavity, or bore. As used herein, "lumen," "channel," "bore," or "passage" are not limited to a circular cross-section. As used herein, the "free end" of an element is the end portion beyond which such an element does not extend. The terms "at the end," "on the end," "adjacent to the end," or "along the end," unless otherwise stated, may be used interchangeably in this specification without limitation and should be understood as being intended to indicate a general relative spatial relationship rather than a strictly limited location.Finally, any reference to "located in" a place or site is intended to include the vicinity and / or surrounding area of ​​such place or site (e.g., along it, adjacent to it, near it, etc.). Any reference to "located in" a target tissue site is intended to include, and not limited to, the tissue in the vicinity and surrounding area of ​​the target tissue (e.g., along it, adjacent to it, etc.). As understood herein, "corresponding" is intended to convey the relationship between components, parts, elements, etc., that act upon each other or are configured to have a different intended relationship with each other.

[0022] Devices, assemblies, systems, and methods for facilitating tissue cutting, such as tunneling into tissue, are described in accordance with various principles of this disclosure. For example, various devices, assemblies, systems, and methods for separating tissue, such as facilitating tissue cutting, are disclosed. In some embodiments, various devices, assemblies, systems, and methods are disclosed that can apply tensile force to a cut tissue to facilitate further cutting. In some embodiments, various devices, assemblies, systems, and methods of this disclosure enable blunt tissue cutting. In some embodiments, various devices, assemblies, systems, and methods provide a cutting device in addition to an inflatable device to facilitate tissue cutting. It will be understood that, without intent to limit, medical devices, medical instruments, medical devices, etc. may be used interchangeably as described herein. Furthermore, without intent to limit, terms such as cutting, incising, excising, and extracting, including other grammatical forms, may be used interchangeably as described herein. Furthermore, with respect to cutting devices, this disclosure may, for convenience, refer to surgical knives such as electrosurgical units, but other types of cutting devices such as blades, surgical scalpels, and laser-based cutting devices may be used instead. Such cutting devices may be inserted into a target site through a medical scope, such as a gastroscope or endoscope, through the working channel of the medical scope, to facilitate insertion into the target site, navigation, etc., while protecting the body passage or lumen through which the medical scope is navigated. In this specification, target site, anatomical site, treatment site, etc., may be referred to interchangeably without intent to limit.

[0023] According to various principles of this disclosure, using an inflatable device in conjunction with a cutting device enables safer and / or faster procedures, such as third-space endoscopic procedures. For example, the cutting device may be used to initiate the separation of tissue at a target site, and the inflatable device may then be used to separate the cut tissue. For example, the tissue may first be cut using the cutting device of the system. Optionally, a fluid may be injected into the target site to facilitate such cutting by generating a bleb at the target site before cutting. The inflatable device may be inserted into the cutting area and inflated to apply pressure (e.g., mechanical radial and / or perpendicular forces on the tissue) to cause the tissue to be pushed apart, as can be achieved by a blunt instrument. Once the tissue is separated by the inflatable device, a medical professional can observe the amount / degree of tissue removed to determine whether further cutting is medically necessary. For example, the cutting device and the inflatable device may be delivered together with a medical scope having a visualization device such as a camera. The scope may be used, for example, to visualize the cutting area during the separation of the cut tissue by the inflatable device. In some embodiments, the inflatable device may be deflated to provide an unobstructed view for the visualization device. In some embodiments, the inflatable device is transparent and filled with a transparent fluid to facilitate visualization through the inflatable device, even when it is within the field of view of the visualization device. In some embodiments, the inflatable device is deflated to facilitate visibility. Deflation allows visualization of the degree of separation created by the cutting device and / or the inflatable device. If further tissue separation is medically required, the cutting device and / or the inflatable device may be used to further separate the tissue, and visualization may be used again to assess the degree of tissue separation, and such actions may be repeated as medically required.

[0024] The inflatable device is typically located proximal to the cutting device. In some embodiments, the inflatable device and the cutting device are able to advance / retract independently of each other and of the target site. In some embodiments, the cutting device and the inflatable device advance independently of each other to the target site, such as on separate elongated members. In some embodiments, the inflatable device advances on a tubular elongated member that extends over the elongated member from which the cutting device is extended (i.e., the elongated member delivering the cutting device extends through the lumen of the tubular elongated member delivering the inflatable device).

[0025] In some embodiments, the inflation of the inflatable device may be gradual. For example, in some embodiments, the distal portion of the inflatable device is inflated before the proximal portion of the inflatable device is inflated. In some embodiments, the inflatable device includes two or more independently inflatable portions such that the distal portion can be inflated separately before the proximal portion is inflated. In some embodiments, a sheath is provided covering the inflatable device and is retracted proximal to the inflatable device (and / or the inflatable device may extend distal to the sheath), gradually exposing the inflatable portion of the inflatable device and thereby changing the effective length of the inflatable device. In some embodiments, the amount of fluid in the inflatable device affects the pressure within the inflatable device and, consequently, the pressure applied by the inflatable device to the tissue at the target site.

[0026] In some embodiments, the inflatable device is a balloon. In some embodiments, the inflatable device is formed from an inflexible material. In some embodiments, the inflatable device is inflated by an inflation medium such as a fluid (e.g., saline solution, water, air, etc.). It will be understood that the inflatable device may have any of a variety of sizes, shapes, configurations, and / or dimensions, selected in consideration of the properties of the target site and various other characteristics.

[0027] Next, various embodiments of the tissue tunneling devices, assemblies, systems, and methods will be described with reference to examples shown in the accompanying drawings. References in this specification to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” indicate that one or more specific features, structures, concepts, and / or properties according to the principles of this disclosure may be included in relation to that embodiment. However, such references do not necessarily mean that all embodiments include that particular feature, structure, concept, and / or property, or that one embodiment includes all of those features, structures, concepts, and / or properties. Some embodiments may include one or more such features, structures, concepts, and / or properties in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or properties described with reference to one embodiment can be combined with one or more of the features, structures, concepts, and / or properties of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or properties described herein can be mixed or harmonized to create hybrid embodiments, and such hybrid embodiments are included within the scope of this disclosure. Furthermore, references to “one embodiment,” “a certain embodiment,” “several embodiments,” and “other embodiments” in various parts of this specification do not necessarily all refer to the same embodiment, and separate or alternative embodiments are not necessarily mutually exclusive with other embodiments. It should be further understood that the various features, structures, concepts, and / or characteristics of the disclosed embodiments are independent and distinct from one another, and may be used or presented individually, or may be used or presented in various combinations to create alternative embodiments that are considered part of this disclosure. Therefore, because describing all the numerous possible combinations and partial combinations of features, structures, concepts, and / or characteristics would be too cumbersome, this disclosure is not limited to the embodiments specifically described herein, and the examples of embodiments disclosed herein are not intended to limit broader aspects of this disclosure.The various dimensions provided herein are examples only, and those skilled in the art will understand that they can easily determine the standard deviations covered by this disclosure and any claims associated therewith, and the appropriate range of acceptable modifications from those standard deviations. The following description is merely an exemplary example of the embodiments and is not intended to limit any broader aspects of this disclosure.

[0028] In the drawings, common features are identified by common reference elements, and for the sake of brevity and convenience, and without the intention of limitation, descriptions of common features are generally not repeated. For the sake of clarity, not all components with the same reference number are numbered. In the following description, elements, components, members, etc., that are similar between various exemplary embodiments are generally indicated by the same reference number, which is a multiple of 100, and redundant descriptions are generally omitted for brevity. Furthermore, certain features in one embodiment may be used across various embodiments and are not necessarily individually labeled when they appear in different embodiments.

[0029] Referring here to the drawings, Figure 1 illustrates an example embodiment of a tissue tunneling system 100 having a tissue tunneling assembly 102 including a cutting device 110 and an inflatable device 120 positioned relative to each other to separate tissue / form a tunnel within the tissue according to various principles of the present disclosure. In the example of the illustrated embodiment, the inflatable device 120 is located proximal to the cutting device 110. Thus, the cutting device 110 may be located distal to the cutting device 110 at a target site so as to contact the tissue at the target site before the inflatable device 120 contacts the tissue. The cutting device 110 is operated / activated to initiate the operation of the tissue tunneling system 100 toward the target site, such as by cutting the tissue. The inflatable device 120 is advanceable and is activated after (or possibly while) the tissue has been cut by the cutting device 110 to further separate the cut tissue. More specifically, once the initial cutting of tissue at the target site is performed by the cutting device 110, the inflatable device 120 can be inserted into the cut created by the cutting device 110, for example, by advancing the tissue tunneling system 100 distally. The inflatable device 120 can then expand / inflate to separate the cut tissue and further form a tunnel within the target site.

[0030] In the embodiment shown in Figure 1, the cutting device 110 and the inflatable device 120 are located at the distal end 100d of the tissue tunneling system 100 for advancement to the target site. In some embodiments, the distal end 100d of the tissue tunneling system 100 is advanced into the patient's body through a medical scope, such as an endoscope or gastroscope, to the target site inside (the configuration of which is known to those skilled in the art and therefore does not require illustration for its understanding). In the embodiment shown in Figure 1, the cutting device 110 (and optionally the inflatable device 120 as well) may be advanced to the target site using an elongated member 130. The elongated member 130 may also be referred to herein as an elongated delivery member 130 to distinguish it from other elongated members described herein. In an example of an embodiment of the tissue tunneling system 100 shown in Figure 1, the cutting device 110 extends distally from the distal end 130d of the elongated member 130 for advancement to the target site, but other arrangements are also within the scope and spirit of the disclosure. In some embodiments, the cutting device 110 is operably coupled to the elongated member 130, such as being attached to the elongated member 130. As shown in Figure 1A, which further details region 1A of Figure 1, and Figure 1B, which further details region 1B of Figure 1A, in some embodiments, the elongated member 130 has a lumen 131 through which it passes. In some embodiments, the cutting device 110 or at least its proximal portion is retractable into the lumen 131 of the elongated member 130 and extendable from the lumen 131. For example, the cutting device 110 may be extended and delivered to a retracted target site, or it may be at least partially retracted into the lumen 131 of the elongated member 130 to protect the cut end of the cutting device 110 from the passage through which the cutting device 110 is advanced to the target site, and / or to protect the cut end of the cutting device 110 when not in use for cutting (e.g., during blunt tissue dissection). The position 110t of the distal end of the cutting device 110 may be adjusted relative to the distal end 130t of the elongated member 130 by advancing or retracting the cutting device 110 relative to the elongated member 130 (e.g., through the lumen 131 of the elongated member 130).For example, the cutting device 110 may advance or retract relative to the elongated member 130 to advance the cutting device 110 further into the tissue and / or to adjust the length of the cut portion, for example, to adjust various cutting parameters in a manner known to those skilled in the art. If the cutting device 110 is an electrosurgical unit, the electrical connection to the cutting device 110 may extend through the lumen 131 of the elongated member 130 to supply power to the cutting device 110. The cutting device 110 is illustrated as a T-shaped electrosurgical unit (for example, having electrodes configured for precision cutting), but the disclosure is not limited in this respect.

[0031] In some embodiments, the navigation, maneuvering, positioning, etc., of the cutting device 110 and / or inflatable device 120 may be controlled via an elongated member 130. The elongated member 130 preferably has sufficient flexibility to navigate through meandering paths within the human body. Optionally, the elongated member 130 is configured to advance through a working channel of the insertion member of a medical scope. In some embodiments, the navigation, maneuvering, positioning, etc., of the elongated member 130 is controlled via a medical scope through which the elongated member 130 is advanced to a target site.

[0032] As described above, an example of an embodiment of the inflatable device 120 shown in Figure 1 may be operably associated with an elongated member 130 delivered to a target site together with the cutting device 110. For example, the inflatable device 120 is shown in Figure 1 and Figure 1A (showing area 1A of Figure 1 in more detail) as being mounted on the distal end 130d of the elongated member 130. However, other configurations of the tissue tunneling system 100 having the inflatable device 120 delivered to a target site together with or after the cutting device 110 are also within the scope and spirit of the disclosure, and various examples of alternative embodiments are described in more detail below. Also as described above, the inflatable device 120 of the tissue tunneling system 100 formed by various principles of the disclosure is expanded or inflated to separate tissue at a target site, such as tissue previously cut by the cutting device 110 of the tissue tunneling system 100. The inflation of the inflatable device 120 can be controlled by a medical professional to achieve the desired separation of tissue at the target site by establishing the size of the inflatable device 120 (e.g., cross-sectional size such as diameter or cross-sectional area) and, optionally, the associated pressure applied by the inflatable device 120. In some embodiments, the tissue tunneling system 100 includes an inflatable device controller 140 that is fluidically coupled to the inflatable device 120, for example, via a lumen passing through an elongated member 130 (such as when the inflatable device 120 is operably coupled to the elongated member 130 and delivered together with it to the target site). Additionally or alternatively, a separately formed lumen (e.g., extending along the elongated member 130) may fluidly couple the inflatable device controller 140 and the inflatable device 120. In the example of the embodiment shown in Figure 1, the inflatable device controller 140 is shown as a syringe having an inflatable medium (e.g., fluid) that can be filled into the inflatable device when the inflatable device controller 140 is activated. However, it will be understood that other configurations of inflatable device controllers, such as other forms of fluid sources or injection devices (e.g., having manual or automatic fluid pumps and / or pressure gauges), are within the scope and spirit of this disclosure.

[0033] In some embodiments, in addition to being fluidically coupled with a fluid delivery device or system to deliver an inflatable fluid to the inflatable device 120, the tissue tunneling system 100 may also deliver fluid to a target site to generate a bleb at the target site to facilitate cutting by the cutting device 110. In some embodiments, a fluid (e.g., water, saline, air, etc.) is delivered through a defined lumen 131 via an elongated member 130 through which the cutting device 110 is delivered and injected into the target site. The fluid may be injected into the target site to generate a bleb and facilitate cutting by the cutting device 110. In some embodiments, such as shown in Figure 1B, the lumen 131 is fluidically coupled with a lumen 111 extending through the cutting device 110, and the injected fluid is delivered via the cutting device 110.

[0034] As described above, once the cutting device 110 is activated to cut tissue at the target site, the inflatable device 120 may be inserted into the separated / cut area of ​​tissue. Thus, the inflatable device 120 may be a blunt cutting instrument of the tissue tunneling system 100 that can perform blunt tissue dissection. The inflatable device 120 is initially inserted in a deflated or at least partially deflated configuration and can then be inflated (e.g., gradually inflated) to separate the tissue along the cut created by the cutting device 110. A medical professional can assess the target site to determine whether further cutting is medically necessary for the procedure being performed. For example, a visualization instrument (e.g., a camera) may be inserted to view the cut area, such as with the inflatable device 120 that separates and holds the already separated tissue layers. In some embodiments, the inflatable device 120 is delivered to the target site by the use of a medical scope as described above, and the visualization instrument is a visualization element associated with the medical scope (e.g., a camera, optical fiber, etc., extending through components of the medical scope, etc.). Optionally, the inflatable device 120 may be further inflated to further separate the tissue initially separated by the cutting device 110.

[0035] A tissue tunneling system 100 formed by various principles of this disclosure optionally includes a control handle 150 at its proximal end 100p, as shown in Figure 1. An illustrated example of an embodiment of the control handle 150 may be operably associated with the cutting device 110 and / or the inflatable device 120 and held in the hand of a medical professional while operating the tissue tunneling system 100. Movement of the control handle 150 may be transmitted to one or more members / elements of the tissue tunneling system 100, for example, to manipulate the position of the tissue tunneling system 100 relative to a target site. In some embodiments, the control handle 150 is operably associated with the cutting device 110 and / or the inflatable device 120, and as a result, the medical professional can control the operation of the cutting device 110 and / or the inflatable device 120 via the control handle 150.

[0036] An example of an embodiment of the control handle 150 shown in Figure 1 includes a cutting device controller 152 operably associated with the cutting device 110. An illustrated example of an embodiment of the cutting device controller 152 is movable relative to the control handle 150 to move the cutting device 110 at the distal end 100d of the tissue tunneling system 100. In some embodiments, the cutting device controller 152 is slidable relative to the control handle 150. For example, in some embodiments, the cutting device controller 152 is distally movable to advance the cutting device 110 distally and proximal movable to retract the cutting device 110 proximal. In some embodiments, the distal and proximal movement of the cutting device 110 may be relative to the distal end of the elongated delivery member 130 to adjust the length of the cutting device 110 extending distal to the distal end 130t of the elongated delivery member 130. As those skilled in the art will understand, modifications to the cutting device 110 may be desirable, for example, to adjust various cutting parameters (e.g., the length of the cutting element, the amount of energy supplied to an electric cutting device such as an electrosurgical unit to adjust energy delivery to the tissue).

[0037] In embodiments where the cutting device 110 is an electrosurgical unit, the control handle 150 may include an electrical connector 154 configured to electrically couple the cutting device 110 to a power source (as is known to those skilled in the art, and therefore no further detailed illustration is needed). In embodiments where a fluid is injected into a target site (e.g., to generate a bleb to facilitate cutting), a fluid port 156 may be provided along the control handle 150. The fluid port 156 may be fluidically coupled to a lumen 131 through an elongated member 130 (as shown in Figure 1B). For example, in some embodiments, the fluid port 156 is fluidically coupled to a lumen 131 of the elongated member 130 for delivery from the distal end 130d of the elongated member 130 to the target site. In some embodiments, the fluid may be delivered through the lumen 131 of the elongated member 130 using the cutting device 110. Optionally, the fluid is delivered through a defined lumen 111 via the cutting device 110.

[0038] In some embodiments, the inflatable device controller 140 described above is operably associated with a control handle 150. For example, an example of an embodiment of the control handle 150 shown in Figure 1 includes a port 158 ​​to which the inflatable device controller 140 can be fluidically coupled to deliver fluid to the inflatable device 120. In some embodiments, the expansion medium is delivered to the inflatable device 120 via a lumen, through an elongated member 130 (for example, through a lumen 131 in which the cutting device 110 extends), or through a separate tubular elongated member extending along or through the elongated member 130.

[0039] As described above, the inflatable device 120 is delivered to a target site proximal to the cutting device 110. In the example of the embodiment shown in Figure 1, the inflatable device 120 is attached to the distal end 130d of an elongated member 130 from which the cutting device 110 can be advanced (as described above), and is therefore proximal to the cutting device 110. As shown in region A of Figure 1, and as shown in more detail in Figure 1A, the inflatable device 120 may be attached proximal to the farthest end 130t of the elongated member 130, and therefore proximal to the cutting device 110. However, other arrangements are also within the scope and spirit of the disclosure. For example, as shown in Figure 1C, which shows a modified arrangement of elements in region 1A of the tissue tunneling system 100 as shown in Figure 1, the inflatable device 120 of a tissue tunneling system 100 formed by various principles of the disclosure may be located closer to the cutting device 110 than shown in Figure 1A, for example, leaving little gap between them. For example, the inflatable device 120 may be located approximately 0-2 cm from the most distal end 130t of the elongated delivery member 130.

[0040] According to the various principles of this disclosure, the cutting device and the inflatable device of a tissue tunneling system formed according to the various principles of this disclosure do not need to be fixed to each other. Additionally or alternatively, the cutting device and the inflatable device do not need to be operably associated with the same elongated member for delivery to a target site. For example, the cutting device of a tissue tunneling system formed according to the various principles of this disclosure may be delivered together with a first elongated member, while the inflatable device of the system may be delivered separately with a second elongated member, and so on. Therefore, the inflatable device does not need to be fixed to the cutting device or to an elongated member to which the cutting device is operably associated (e.g., fixedly or otherwise coupled or attached for delivery to a target site), and thus the axial distance between the cutting device and the inflatable device may be adjustable. For example, in the embodiment of the tissue tunneling system 200 shown in Figure 2, the inflatable device 220 is attached to a separate elongated member 260 that can advance to a target site independently of the elongated member 230, and the cutting device 210 is advanced to the target site using or on the elongated member 230. Thus, the cutting device 210 and the first elongated member 230 are separate and movable independently of the inflatable device 220 and the second elongated member 260. In some embodiments, the second elongated member 260 is a tubular elongated member having a lumen 261 defined through which it passes. In some embodiments, the lumen 261 of the second elongated member 260 is sized so that the first elongated member 230 extends through the lumen 261. Therefore, the cutting device 210 can be delivered to a target site within the distal end 260d of the second elongated member 260, which is configured as a sheath covering the distal end 210d of the cutting device 210. In some embodiments, the second elongated member 260 is sized to extend through a further tubular elongated delivery member, such as a working channel of a medical scope, as described above with reference to an example of an embodiment of the tissue tunneling system 100 shown in Figure 1.Various other elements, members, assemblies, devices, etc. of the structural tunneling system 200 shown in Figure 2, which are similar to or substantially identical to the elements of the structural tunneling system 100 shown in Figure 1, are indicated by the same reference numerals with 100 added, and it will be understood that for brevity, their descriptions provided with respect to Figure 1 are to be referenced.

[0041] As described above, the inflatable devices of the tissue tunneling system formed by the various principles of this disclosure may be inflatable to different diameters. To gradually increase the distance between tissue layers at a target site (for example, at a cut created by the cutting device of this disclosure), the inflatable devices of this disclosure may be gradually inflated. In some embodiments, in addition to or instead of gradually inflating, a sheath 370 may be provided covering the inflatable device 320 formed by the various principles of this disclosure to regulate the expansion within the cut tissue, as in the example of an embodiment of the tissue tunneling system 300 shown in Figure 3.

[0042] More specifically, an example of an embodiment of the tissue tunneling system 300 shown in Figure 3 includes a tubular elongated member 370 that covers an inflatable device 320 and has a distal end 370d movable relative to it, the inflatable device 320 located proximal to the cutting device 310. The tubular elongated member 370 has a lumen 371 that is sized to accommodate the inflatable device 320 within the lumen 371 and is axially defined through it. For convenience, and without intent to limit, the tubular elongated member 370 may be referred to herein as a sheath 370 to distinguish it from other tubular elongated members of tissue tunneling systems formed by the various principles of the present disclosure. In some embodiments, the inflatable device 320 may be delivered to a target site within the distal end 370d of the sheath 370. In some embodiments, the inflatable device 320 is delivered distal to the distal end 370d of the sheath 370, and the sheath 370 is advanceable distally over the inflatable device 320 to adjust the inflation / expansion size of the inflatable device 320. More specifically, the sheath 370 may be positioned over the inflatable device 320 in a selected axial range (e.g., along the length of the inflatable device 320, such as along the longitudinal axis of the tissue tunneling system 300), thereby affecting the axial range / length of the inflatable portion of the inflatable device 320 that is not limited, suppressed, or constrained within the lumen 371 of the sheath 370 (e.g., the axial range of the inflatable device 320 extending distally beyond the distal end 370d of the sheath 370). The sheath 370 may be advanceable distally and / or retractable proximal to the inflatable device 320 to adjust the length of the inflatable portion of the inflatable device 320. Such adjustment of the length of the inflatable portion of the inflatable device 320 may be advantageous in influencing the amount of tissue separated by the inflatable device 320 when inserted between tissues and inflated.

[0043] In some embodiments, a grip 372 (e.g., a wider diameter portion, a portion covered with a gripping material such as a cushioning and / or non-slip material, a textured portion for comfort and / or to reduce slippage when gripped by hand) is provided at the proximal end 370p of the sheath 370 to facilitate gripping by a medical professional and / or connection to another controller of the sheath 370 (e.g., an automated controller). In some embodiments, the sheath 370 is axially movable relative to an elongated member 330, such as extending axially movably over an elongated member 330 that can be used to deliver a cutting device 310 to a target site. For example, the cutting device 310 of a tissue tunneling system 300 as shown in Figure 3 is operably associated with the elongated member 330 (e.g., attached to the distal end 330d of the elongated member 330) and can be advanced toward the target site together with the distal end 330d of the elongated member 330. The inflatable device 320 is similarly positioned proximal to the cutting device 310 for delivery to the target site. It will be understood that the inflatable device 320 may be operably associated with (e.g., attached to) the elongated member 330, or may be operably associated with (e.g., attached to) a separate, independent second elongated member, as described above with respect to an example embodiment of the tissue tunneling system 200 shown in Figure 2.

[0044] In use, the cutting device 310 may first be activated to create an initial cut at the target site. The inflatable device 320 may then be inserted, at least partially, into the cutting area of ​​the tissue. In some embodiments, as described above, the inflatable device 320 may be delivered to the target site while it is (completely) within the lumen 371 of the sheath 370. The inflatable device 320 may be extended within the cutting area, within the sheath 370, or with at least a portion of the device extending distally beyond the sheath 370 beyond the most distal end 370t of the sheath 370. According to various principles of this disclosure, the sheath 370 is movable relative to the inflatable device 320 (e.g., axially movable). More specifically, the sheath 370 is retractable proximal and / or the inflatable device 320 is advancing distally relative to the inflatable device 320 to expose / visualize a selected length of the inflatable device 320. When the inflatable device 320 is inflated, the sheath 370 can be retracted proximally and / or advanced distally relative to the inflatable device 320 to change the portion / length of the inflatable device 320 that extends outside the sheath 370. The portion / length of the inflatable device 320 outside the sheath 370 is not constrained by the sheath 370 and therefore at least such portion of the inflatable device 320 can be inflated to a desired (e.g., to the maximum) cross-sectional size (lateral to the axial length of the inflatable device 320) to isolate tissue at a target site. As can be understood, the position of the sheath 370 relative to the inflatable device 320 when the inflatable device 320 is inflated affects the distribution of the inflating fluid (and optionally the pressure) within the inflatable device 320.

[0045] Various positions of the sheath 370 relative to the inflatable device 320, such as within region 3 of the tissue tunneling system 300 as shown in Figure 3, are shown in Figures 3A to 3C. As can be understood, the position of the sheath 370 relative to the inflatable device 320 determines / controls the length of the inflatable device 320 that can be inflated. As shown in Figure 3A, the sheath 370 covers the proximal portion 320p of the inflatable device 320 and restricts the inflation of such proximal portion 320p. Thus, the distal portion 320d of the inflatable device 320 is inflated to a greater extent than the proximal portion 320p can be inflated. When the sheath 370 moves further proximal to the inflatable device 320, more of the inflatable device 320 is advanced from the lumen 371 of the sheath 370. As shown in Figure 3B, the distal portion 320d of the inflatable device 320, which has a larger spread than shown in Figure 3A, extends outside the lumen 371 of the sheath 370, while the smaller proximal portion 320p remains within the lumen 371. In some embodiments, the sheath 370 may be retracted completely from the covering of the inflatable device 320 to allow for unlimited (along its entire length / total range) inflation of the inflatable device 320, as shown in Figure 3C. In some embodiments, Figures 3A–3C may be considered to show a series of stages of retraction of the sheath 370 relative to the inflatable device 320. In some embodiments, the sheath 370 may be retracted proximal and then extended distally during the same procedure, for example, depending on the condition of the target site.

[0046] Optionally, a tissue tunneling system 300, such as the one shown in Figure 3, includes a mechanism 380 configured to hold the sheath 370 in place relative to the inflatable device 320, such as maintaining the inflatable device 320 to a desired extent of extension from the sheath 370. In some embodiments, such a mechanism 380 is positioned and / or mounted adjacent to or relative to a grip 372. An example of an embodiment of the holding mechanism 380 is shown in Figure 3D as an adapter mechanism 380, such as a Tuohy-Borst, which, when the mechanism 380 is tightened, can hold the sheath 370 in place (for example, relative to an elongated member 330). For example, the sheath 370 may include a male threaded extension 382, ​​over which a female threaded collar 384 is positioned. Similar to the toyboast adapter, rotation of the collar 384 relative to the extension 382 allows the gasket 386 (mounted on the elongated member 330) within the collar 384 to tighten onto the elongated member 330. Those skilled in the art will understand that other suitable mechanisms known to them, such as collet configurations, clamps, etc., can be used instead of the toyboast configuration. The user can thereby set / fix the inflation length of the inflatable device 320 to a desired extent.

[0047] It will be understood that the provision of the sheath 370 as shown in Figure 3 may, advantageously, allow for the use of a longer balloon than might initially be considered for use in a given situation. Depending on the clinical scenario, if the user wishes to use a balloon length of only a few millimeters for tissue separation, the remainder of the inflatable device 320 may remain within the lumen 371 of the sheath 370 without affecting the target site. The sheath 370 may be progressively retracted to increase the length of the inflatable device 320, which is configured to be inflated and separate the tissue at the target site when it is determined that further tissue separation is medically required.

[0048] It will be further understood that the use of the sheath 370 can advantageously limit the impact of the expansion of the inflatable device 320 on another tubular elongated delivery member (e.g., a medical scope) to which the inflatable device 320 can be delivered to a target site (e.g., as described above). For example, the expansion of the proximal portion 320p of the inflatable device 320 can be suppressed by the sheath 370. Also, the relative position of the distal end 370d of the sheath 370 and the distal end of the tubular elongated delivery member can be adjusted to coordinate the expansion of the inflatable device 320 relative to the tubular elongated delivery member. Thus, the expansion of the inflatable device 320 does not need to begin within the tubular elongated delivery member (such an initiation could cause proximal movement of the tubular elongated delivery member as the inflatable device 320 expands).

[0049] The sheath 370 for adjusting the expandable device, as shown in Figure 3, may be included in other embodiments of tissue tunneling systems formed by various principles of this disclosure, but are not limited to, examples of embodiments of tissue tunneling systems 100 and 200 shown in Figures 1 and 2, respectively. Furthermore, various other elements, members, assemblies, devices, etc., of the tissue tunneling system 300 shown in Figure 3 that are similar to or substantially identical to the elements in the tissue tunneling system 100 shown in Figure 1, are denoted by the same reference numerals with 200 added, and for brevity, their descriptions provided with respect to Figure 1 should be referenced.

[0050] According to various principles of this disclosure, a tissue tunneling system may have two or more inflatable devices configured to separate tissue at a target site, for example, after the tissue has been cut by the cutting device of the tissue tunneling system. Providing two or more inflatable devices may allow for greater variability and / or precision in the separation of tissue at a target site. For example, in the example of an embodiment of the tissue tunneling system 400 shown in Figure 4, the inflatable device 420 includes a first inflatable element 422 and a second inflatable element 424 located proximal to the first inflatable device 422. For convenience, and without intent to limit, two inflatable elements 422, 424 of a multi-element inflatable device 420 formed by various principles of this disclosure are referred to. However, it will be understood that additional inflatable elements may be provided (i.e., the inflatable device may have three or more inflatable elements) for further adjustability of the tissue tunneling system, for example, when used for blunt tissue dissection. Therefore, a reference to a multi-element inflatable device 420 may be made as having two or more inflatable elements that can be considered structurally different from each other (however these inflatable elements can be considered as part of an inflatable device assembly that is generally referred to herein as a multi-element inflatable device 420).

[0051] In some embodiments, the inflatable elements 422, 424 of a multi-element inflatable device 420 formed by various principles of the Disclosure are independently inflatable. In some embodiments, the inflatable elements 422, 424 of the multi-element inflatable device 420 are of different sizes. In an example of the embodiment shown in Figure 4, the distal inflatable element 422 has a smaller diameter than the proximal inflatable element 424. However, the reverse configuration is also within the scope of the Disclosure. In some embodiments, the inflatable elements 422, 424 of a multi-element inflatable device 420 of a tissue tunneling system 400 can be inflated sequentially. For example, the distal inflatable element 422 can be inflated at a target site before the proximal inflatable element 424 is inflated, as shown in Figure 4A, which more schematically illustrates an example of the configuration of region 4 of the tissue tunneling system 400 as shown in Figure 4. The proximal inflatable element 424 may be inflated after the tissue has been separated by the distal inflatable element 422 and a determination has been made as to whether further inflation of the proximal inflatable device 424 is medically necessary. In some embodiments, the distal inflatable element 422 may remain inflated, as shown in region A of Figure 4, when the proximal inflatable element 424 is inflated, so as to increase the separation of tissue at the target site. In some embodiments, the distal inflatable element 422 may deflate during or after the inflation of the proximal inflatable element 424, as shown in Figure 4B, which schematically shows an example of the configuration of detail region 4 of a tissue tunneling system 400, such as Figure 4. Various other combinations of the order and / or degree of inflation of the elements of the multi-element inflatable device 420 are within the scope and spirit of this disclosure.

[0052] The multi-element inflatable device 420 shown in Figure 4 may be included in other embodiments of tissue tunneling systems formed by various principles of this disclosure, but are not limited to, examples of embodiments of tissue tunneling systems 100, 200, and 300 shown in Figures 1, 2, and 3, respectively. Furthermore, various other elements, members, assemblies, devices, etc. of the tissue tunneling system 400 shown in Figure 4, which are similar to or substantially identical to the elements in the tissue tunneling system 100 shown in Figure 1, are denoted by the same reference numerals with 300 added, and for brevity, their descriptions provided with respect to Figure 1 should be referenced.

[0053] It will be understood that the inflatable devices shown in the accompanying drawings are merely examples and may be considered schematic. The inflatable devices 120, 220, 320, and 420 do not need to have the exact shape and / or configuration shown. Thus, although they are shown as substantially spherical and / or having a substantially circular cross-sectional shape, the inflatable devices of tissue tunneling systems formed according to the various principles of this disclosure may have shapes / configurations other than spherical. For example, a tissue tunneling system formed according to the various principles of this disclosure may have an inflatable device 520 that is generally elongated in the longitudinal direction, as schematically shown overall in Figure 5 (e.g., showing an alternative configuration of area 1 in Figure 1). Additionally or alternatively, it will be understood that the inflatable devices of tissue tunneling systems formed according to the various principles of this disclosure do not need to have a symmetrical cross-sectional shape. For example, the inflatable devices of a tissue tunneling system formed according to the various principles of this disclosure may have a partially symmetrical configuration (e.g., along only one axis) or may be asymmetrical. Additionally or alternatively, the cross-sectional shape of an inflatable device in a tissue tunneling system formed by various principles of the present disclosure may be configured to facilitate insertion of the inflatable device into tissue pre-cut by a cutting device located distal to the inflatable device in the tissue tunneling system. For example, an example of an embodiment of a partially symmetric inflatable device 620 is shown in Figure 6A (for example, showing another alternative configuration of region 1 in Figure 1). In some embodiments, the partially symmetric inflatable device 620 has a generally elongated cross-sectional shape, as shown in Figure 6B, with a first cross-sectional dimension D1 that is larger than a second cross-sectional dimension D2 in the lateral (e.g., perpendicular) direction relative to a first cross-sectional dimension D1. In some embodiments, the cross-section of the partially symmetric inflatable device 620 may be oval. In some embodiments, the cross-sectional shape of the partially symmetric inflatable device 620 has narrower sides, such as those formed by a lateral extension or wing portion 622, so that the partially symmetric inflatable device 620 has a larger first cross-sectional dimension D1 along the direction in which the wing portion 622 extends.In some embodiments, the wing portion 622, as shown in Figure 6B, can thus facilitate insertion into the narrow cut of tissue at the target site by providing a relatively flat portion of the inflatable device 620 for insertion into the cut initially created by the cutting device 610. The expansion of the partially symmetric inflatable device 620 can allow the tissue to be wedge-shaped as a wider portion is further inserted into the cut. The rotation of the partially symmetric inflatable device 620 can further separate the tissue at the cut. Various other configurations besides multiple elements and / or asymmetric cross-sections of the inflatable device can be used by various principles of this disclosure to wedge-shape the tissue at the target site. For example, the shape of the inflatable device formed by various principles of this disclosure can taper distally (e.g., it may have a substantially conical or wedge shape) to gradually increase the size of the inflatable device as the device is distally inserted between the cut tissue at the target site. It will be understood that inflatable devices may be formed by various principles of this disclosure having various other shapes and configurations other than those described above, without departing from the scope and spirit of this disclosure.

[0054] Those skilled in the art will understand that this paper is merely a description of exemplary embodiments and is not intended to limit the broader aspects of the disclosure. Therefore, while the inflatable devices disclosed herein are described as being used in conjunction with cutting devices such as electrosurgical units, other uses of such inflatable devices are also conceivable. The concepts disclosed herein include peroral endoscopic myotomy (POEM), recanalization for complete esophageal obstruction (peroral endoscopic tunneling for esophageal recovery), endoscopic submucosal dissection (ESD), submucosal tunneling endoscopic resection (STER), Zenker's diverticulotomy (ZPOEM), endoscopic gastric pyloromyotomy (GPOEM), per-rectal endoscopic myotomy, diverticular POEM, and tunneling recanalization of the It will become clear that this may be particularly suitable for use in other third-space endoscopic procedures, such as those used in the treatment of esophagus (POETRE) and early-stage cancers of the gastrointestinal tract. However, the concepts disclosed herein may also have broader applications.

[0055] All devices and methods discussed herein are embodiments of devices and / or methods implemented in accordance with one or more principles of this disclosure. These embodiments are merely examples and not the only ways of implementing these principles, and are not intended to limit the broader aspects of this disclosure. Therefore, references to elements, structures, or features in the drawings should be understood as references to embodiments of the embodiments of this disclosure, and should not be understood as limiting the disclosure to any particular element, structure, or feature shown. Those skilled in the art will be able to recall other examples of ways of implementing the disclosed principles by reading this disclosure. Those skilled in the art will see that modifications can be applied to the disclosed devices, systems, and / or methods, and / or the sequence of steps of the methods described herein, without departing from the concept, spirit, and scope of this disclosure. It will be understood that various features described in relation to one embodiment can typically be applied to other embodiments, whether expressly shown or not. The various features described hereafter can be used individually or in any combination thereof. Therefore, the present invention is not limited to the embodiments specifically described herein, and all substitutions and modifications that are obvious to those skilled in the art are deemed to fall within the spirit, scope, and concept of this disclosure as defined by the appended claims.

[0056] The preceding discussions are broadly applicable and are presented for illustrative and explanatory purposes only, and are not intended to limit the disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions can be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the disclosure. In particular, it will be apparent to those skilled in the art that the principles of the disclosure can be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the disclosure are grouped together as 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 disclosure can be combined as alternative aspects, embodiments, or configurations. Although the disclosure is presented in terms of embodiments, it should be understood that various distinct features of the subject matter do not all need to be present to achieve at least some of the desired characteristics and / or advantages of the subject matter or such individual features. Those skilled in the art will understand that the Disclosure can be used without departing from the principles, spirit, or scope of the Disclosure, with numerous modifications specifically adapted to particular environmental and operating requirements, or with modifications to the structure, arrangement, proportions, materials, components, and other elements used in the practice of the Disclosure. For example, elements shown as integrally formed can be composed of multiple parts, or elements shown as multiple parts can be integrally formed, the operation of elements can be reversed or otherwise modified, and the size or dimensions of elements can be changed. Similarly, while operations, actions, or procedures are described in a particular order, this should not be understood as meaning that such a particular order is necessary to achieve the desired result, or that all operations, actions, or procedures should be performed. Furthermore, other forms of implementation are also within the scope of the following claims. In some cases, the desired result can still be achieved by performing the actions listed in the claims in a different order.Therefore, the embodiments of this disclosure should be considered in all respects to be illustrative and not limiting, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to any specific embodiment or arrangement described or illustrated herein. In consideration of the foregoing, any individual feature of any embodiment may be used separately or in combination with the features of that embodiment or any other embodiment, and may be claimed, the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0057] In the above description and the following claims, the following points should be understood: The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that, when used herein, function both conjunctively and disjunctively. The terms “a,” “an,” “the,” “first,” “second,” etc., do not exclude plurals. For example, the term “a” or “an” entity, when used herein, refers to one or more of those entities. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. When used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the content clearly indicates otherwise. When used herein, the conjunction "and" includes each of the structures, components, features, etc. that are thus joined, unless the context clearly indicates otherwise, and the conjunction "or" includes one or more of the structures, components, features, etc. that are thus joined, individually, and in any combination and number, unless the context clearly indicates otherwise. All references to direction (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, downward, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or to distinguish areas of relevant elements from one another, and do not limit the relevant elements in particular with respect to the location, orientation, or use of this disclosure. References to connections (e.g., attached, joined, connected, engaged, and joined) should be interpreted broadly and, unless otherwise indicated, may include intermediate members between sets of elements and relative movement between elements. Therefore, references to connections do not necessarily imply that two elements are directly connected and in a fixed relationship with one another.References to identification (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.

[0058] The following claims are incorporated by this reference into this “Mode for Carrying Out the Invention,” and each claim stands independently as a distinct embodiment of the present disclosure. In the claims, the terms “comprises,” “comprising,” “includes,” and “including” do not preclude the existence of other elements, components, features, groups, areas, integers, steps, operations, etc. Furthermore, individual features may be included in different claims, but these features may, in some cases, be advantageously combined, and their inclusion in different claims does not imply that the combination of features is unfeasible and / or unfavorable. Furthermore, singular references do not preclude plurals. Reference numerals in the claims are provided merely as examples of clarification and should never be construed as limiting the claims.

Claims

1. A tissue tunneling system having a proximal end and a distal end, A control handle located at the proximal end of the tissue tunneling system, An elongated delivery member extending distally from the control handle, A cutting device operably associated with the elongated delivery member for delivery located at the distal end of the tissue tunneling system, A tissue tunneling system comprising an inflatable device operably associated with the distal end of the tissue tunneling system.

2. The tissue tunneling system according to claim 1, wherein the inflatable device is operably associated with the distal end of the tissue tunneling system which is delivered to a target site proximal to the cutting device.

3. The tissue tunneling system according to claim 1 or 2, wherein the expandable device is movable in the axial direction relative to the cutting device.

4. The tissue tunneling system according to any one of claims 1 to 3, wherein the expandable device is operably associated with a tubular elongated member that is axially shiftable relative to the elongated delivery member.

5. The tissue tunneling system according to claim 4, wherein the tubular elongated member defines a lumen through which the tubular elongated member passes, which is in fluid communication with the expandable device, and delivers an expansion medium to the expandable device to selectively expand the expandable device.

6. The tissue tunneling system according to claim 4, wherein the tubular elongated member defines a lumen through the tubular elongated member, and the elongated delivery member is insertable and axially translatable through the lumen of the tubular elongated member, and moves the cutting device and the expandable device relative to each other.

7. A tissue tunneling system according to any one of claims 1 to 6, wherein, in addition to being inflatable, the configuration of the inflatable device is adjustable.

8. A tissue tunneling system according to any one of claims 1 to 7, further comprising a sheath defining a lumen through which the inflatable device passes, the lumen being sized to accommodate the inflatable device, and the sheath being advanceable and retractable relative to the inflatable device in order to extend over the inflatable device or to expose the inflatable device.

9. The tissue tunneling system according to any one of claims 1 to 8, wherein the inflatable device comprises two or more inflatable elements.

10. The tissue tunneling system according to any one of claims 1 to 9, wherein the control handle includes a first lumen for injecting fluid through a defined lumen via the cutting device and a second lumen for injecting an expansion fluid into the expandable device.

11. Organizational tunneling assembly, A cutting device located at the distal end of the tissue tunneling assembly, An expandable device located proximal to the cutting device, Organizational tunneling assemblies, including

12. The tissue tunneling assembly according to claim 11, wherein the expandable device is movable in the axial direction relative to the cutting device.

13. A tissue tunneling assembly according to claim 11 or 12, further comprising a sheath having a lumen through which the sheath is movable axially relative to the inflatable device, and the inflatable device and the lumen are sized so that the inflatable device selectively fits completely or partially into the lumen, partially extends and expands outside the lumen, or fully extends and expands outside the lumen.

14. The tissue tunneling assembly according to any one of claims 11 to 13, wherein the inflatable device comprises two or more separate and independent inflatable elements.

15. The tissue tunneling assembly according to any one of claims 11 to 14, wherein the cutting device is an electrosurgical unit.

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