Devices and systems for endoscopic procedure

Abstract

To provide catheters with navigation-assisting capabilities, such as with navigation-assisting components or equipment, for use within a body.SOLUTION: A wall of a catheter 110 has an interior space therein so that navigation-assisting equipment is positioned within the wall of the catheter 110. The position of the navigation-assisting equipment within the wall of the catheter 110 leaves a working channel 112 clear for passage of a guidewire, cables, medical instruments, cutting instruments, other working tools, etc. through the working channel 112 within the catheter 110 without interference with components of the navigation-assisting equipment.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This disclosure generally relates to the field of catheters. In particular, this disclosure relates to catheters having navigation assistance capabilities, such as navigation assistance components or devices for use within the body, for example.

Background Art

[0002] In various procedures, such as gastrointestinal procedures like cannulation, physicians or other medical professionals need to navigate through complex anatomical structures with limited amounts of feedback (visual, tactile, etc.). For example, the target internal passageway may be oriented at a difficult angle with respect to an endoscopic accessory, have a very small or sealed opening, or include tortuous anatomical structures, obstructions, and / or benign or malignant structures. Medical professionals may need to perform multiple attempts to successfully complete the cannulation. Furthermore, the likelihood of traumatizing the tissue containing or surrounding the target internal passageway increases with the number of cannulation attempts.

[0003] Accordingly, there is a need in the art for methods to improve the success of cannulation procedures.

Summary of the Invention

[0004] This summary of the disclosure is provided to facilitate understanding and those skilled in the art will understand that the various aspects and features of the disclosure can be advantageously used, either separately in some instances or in combination with other aspects and features of the disclosure in other instances. No limitation with respect to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, etc. in this summary.

[0005] According to various principles of the present disclosure, flexible elongate members such as navigation assistance catheters and systems can determine the position of the catheter relative to another object (e.g., a tissue wall or a lumen wall) and communicate such information for use in navigating, orienting, operating, etc. the catheter. In some embodiments, the flexible elongate member includes a navigation assistance sensor that generates a signal that can be converted into a signal or information that can be used when navigating the flexible elongate member, for example, within a body cavity or lumen. Such flexible elongate members and related systems are useful when navigating with respect to the bile duct, pancreatic duct, or any lumen and are potentially useful for use in any of a variety of procedures such as gastrointestinal, urinary, genital, circulatory, respiratory, pulmonary, etc. Although the present disclosure may refer to navigation with respect to the gastrointestinal system and / or bile duct by way of example, the disclosed devices, systems, and methods should not be understood as being limited to such examples.

[0006] In various embodiments described or otherwise within the scope of the present disclosure, a flexible elongate member is disclosed, the flexible elongate member comprising an outer wall and an inner wall, the outer wall and the inner wall defining an internal space therebetween and defining a working channel therein, extending axially between a proximal end of the flexible elongate member and a distal end of the flexible elongate member, the flexible elongate member including at least one sensor, such as a pressure sensor, disposed within the internal space, at least one of the outer wall and the inner wall defining a flexible distal end of the flexible elongate member, and at least one sensor being disposed within the distal end of the flexible elongate member.

[0007] In some embodiments, the at least one sensor comprises at least three pressure sensors that provide direction information. In some embodiments, the at least one pressure sensor comprises at least four pressure sensors equally spaced around the periphery of the internal space.

[0008] In some embodiments, at least one sensor detects a collision of the distal end of a flexible elongate member against an object. In some embodiments, at least one sensor consists of one of an optical fiber, an inductive sensor, or a piezoelectric sensor.

[0009] In some embodiments, the distal end of the flexible elongate member includes a proximal pressure sensing segment and a distal pressure sensing segment that are axially movable relative to each other. In some embodiments, the flexible elongate member further includes a biasing element that biases the proximal pressure sensing segment and the distal pressure sensing segment away from each other in a neutral configuration where the distal end of the flexible elongate member is not in collision with an object.

[0010] In some embodiments, at least one pressure sensor is provided in the proximal pressure sensing segment, and relative movement of the distal pressure sensing segment relative to the proximal pressure sensing segment actuates the at least one pressure sensor to generate a signal. In some embodiments, the signal indicates that the distal end of the flexible elongate member has collided with an object.

[0011] In some embodiments, at least one sensor consists of at least three pressure sensors that are spaced apart and indicate the directionality of a collision against the distal end of the flexible elongate member. In some embodiments, at least one sensor is an optical fiber having a distal end at the distal end of a proximal pressure sensing segment spaced apart from the proximal surface of the distal pressure sensing segment, and relative movement of the distal pressure sensing segment relative to the proximal pressure sensing segment causes a change in an interference pattern generated by reflection of light from the optical fiber against the proximal surface of the distal pressure sensing segment, which indicates the pressure against the distal end of the flexible elongate member.

[0012] In some embodiments, the flexible elongate member further includes a camera within an internal space. In various embodiments described or otherwise within the scope of the present disclosure, a flexible elongate member is disclosed, the flexible elongate member comprising an outer wall and an inner wall, the outer wall and the inner wall defining an internal space therebetween and defining a working channel therein, extending axially between a proximal end of the flexible elongate member and a distal end of the flexible elongate member, the flexible elongate member including at least one navigation assistance sensor disposed within the internal space at the distal end of the flexible elongate member and generating a signal indicative of the distal end of the flexible elongate member encountering an object.

[0013] In some embodiments, the at least one navigation assistance sensor is a pressure sensor capable of detecting a collision of the distal end of the flexible elongate member hitting an object. In some embodiments, the at least one pressure sensor includes at least three pressure sensors that provide direction information. In some embodiments, the at least one pressure sensor includes at least four pressure sensors disposed equidistantly around the periphery of the internal space.

[0014] In some embodiments, the at least one navigation assistance sensor consists of one of an optical fiber, an inductive sensor, a piezoelectric sensor, or a camera. Other sensors such as proximity sensors, optical sensors, temperature sensors, etc. are also within the scope of the present disclosure as well.

[0015] In one aspect, the present subject matter is directed to a navigation assistance system, the navigation assistance system including a handle that houses a navigation device, the navigation assistance system including a flexible elongate member that extends axially between a proximal end and a distal end coupled to the handle, the flexible elongate member including an outer wall and an inner wall that define an internal space therebetween and define a working channel therein, the navigation assistance system including at least one navigation assistance sensor disposed within the internal space at the distal end of the flexible elongate member to generate a signal indicative of the distal end of the flexible elongate member encountering an object, at least one of the outer wall and the inner wall defining the distal end of the flexible elongate member, and the at least one navigation assistance sensor being disposed within the distal end of the flexible elongate member.

[0016] In some embodiments, the at least one navigation assistance sensor consists of one of an optical fiber, an inductive sensor, a piezoelectric sensor, or a camera. Other sensors such as proximity sensors, optical sensors, temperature sensors, etc. are also within the scope of the present disclosure.

[0017] In some embodiments, the navigation assistance system further includes a control unit that processes a signal from the at least one navigation assistance sensor to indicate direction information regarding a collision of the distal end of the flexible elongate member that struck an object.

[0018] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Non-limiting embodiments of the present disclosure will be described by way of example with reference to the accompanying drawings. The accompanying drawings are schematic and are not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the figures within the drawings may vary. For example, the device may be enlarged so that details are distinguishable, but is intended to be reduced, for example, in connection with fitting within a delivery catheter or the working channel of an endoscope. In the figures, identical, substantially identical, or equivalent elements are typically represented by the same letter, and similar elements are typically designated by different similar reference numerals incremented by 100, and duplicate descriptions are omitted. For clarity and brevity, not all elements in all figures are labeled, and not all elements of each embodiment are shown where illustration is not necessary to enable a person skilled in the art to understand the present disclosure.

[0019] The detailed description will be better understood in conjunction with the following accompanying drawings, which represent similar elements with similar reference characters.

Brief Description of the Drawings

[0020]

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Mode for Carrying Out the Invention

[0021] The following detailed description should be read with reference to the drawings that illustrate exemplary embodiments. It is to be understood that the present disclosure is not limited to the particular embodiments described, and thus may vary. All apparatuses, systems, and methods discussed herein are examples of apparatuses, systems, and / or methods implemented in accordance with one or more principles of the present disclosure. Each example of an embodiment is provided for purposes of explanation and is not the only way to implement these principles, but merely an example. Thus, references to elements, structures, or features in the drawings should be understood as references to examples of embodiments of the present disclosure and should not be construed as limiting the present disclosure to the particular elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading the present disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Thus, it is intended that the subject matter embrace such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0022] It will be understood that the present disclosure has been described at various levels of detail in this application. In certain instances, details that are not necessary for one skilled in the art to understand the present disclosure, or details that would obscure recognition of other details, may have been omitted. The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein are to be understood as being generally understood by those skilled in the art to which the present disclosure pertains. All apparatuses and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0023] As used herein, "proximal" refers to the direction or location that is closest to the user (such as a medical professional, clinician, technician, operator, or physician, such terms being used interchangeably without intention of limitation or otherwise) when using the device (such as when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to the direction or location that is farthest from the user when using the device (such as when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Central" means at least generally bisecting a central point, and "central axis", with respect to an opening, is a line that at least generally bisects the central point of the opening and that extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, strut, channel, or bore.

[0024] A variety of treatment devices, instruments, etc. can be delivered via a delivery device, which generally includes a flexible elongate member having one or more working channels that extend substantially longitudinally (axially) between a proximal end and a distal end of the delivery device. It is generally beneficial for the delivery device to be maneuverable, and the delivery device may have multiple different regions of different flexibility or rigidity to facilitate maneuverability. The delivery device and / or an overtube associated therewith are known to those skilled in the art and can be made from any suitable biocompatible material having sufficient flexibility to traverse non-linear or serpentine anatomical structures. Such materials include, but are not limited to, rubber, silicon, synthetic plastics, stainless steel, metal-polymer composites; metal alloys of nickel, titanium, copper cobalt, vanadium, chromium, and iron; superelastic materials or shape memory materials such as nitinol (nickel-titanium alloy); multiple different layers composed of multiple different materials and reinforcements. Such materials can be made or coated with a polymeric material or a lubricious material to allow or facilitate passage of the delivery device therethrough. In some embodiments, the working channels can be made or coated with a polymeric material or a lubricious material to facilitate passage of the introduced medical instrument(s) through the working channel(s).

[0025] It is generally recognized that it is difficult to accurately and consistently position devices such as sphincterotomy knives or papillotome knives for proper cannulation. To maneuver through tortuous lumens within the body, such as the tortuous pathways within the intestine, the delivery device needs to be rotated multiple times. As can be understood, medical professionals may inadvertently advance rather than continuously advance the tip of the delivery device, flexible elongate member, catheter, cannula, or other device or instrument (these terms are used interchangeably herein without limitation, and "catheter" is generally used for simplicity without intending limitation) through the lumen and strike the lumen wall. Such advancement can irritate tissue or even puncture the wall, further causing complications. Similarly, due to the different anatomical structures for each patient, there is not always a clear access path to the papilla or, for example, to the bile duct or pancreatic duct in lung navigation. As a result of trial and error, a cannula may be inserted, lean towards the papilla and advance, and attempt to identify the access location through it.

[0026] According to one aspect of the present disclosure, in a cannulation procedure where appropriate and careful guidance of a cannula or catheter or scope (or other components, such terms are used interchangeably herein without intention of limitation) is desired to reach the treatment site without affecting the tissue along the way, it is desirable to minimize the pressure applied to the distal end of the catheter to zero. According to the present disclosure, a navigation assistance sensor is provided at the distal tip of a delivery device or a flexible elongate member or a catheter (or other components having a lumen passing through it, such terms are used interchangeably herein without intention of limitation), and feedback is provided to a medical professional so that the medical professional can recognize whether the catheter tip has encountered the lumen wall and stop the advancement of the catheter to avoid damage or puncture of the tissue and / or the lumen wall. Any type of sensor can be used, such as a pressure sensor, proximity sensor, optical sensor, temperature sensor, etc., sensors known or publicly known to those skilled in the art suitable for use in a body passage, and / or sensors of suitable size and dimensions, and / or sensors capable of highly sensitive sensing. For example, an optical fiber sensor, inductive sensor, or piezoelectric sensor can be used. In some embodiments, the sensor is configured to provide direction information to a medical professional and assist in the manipulation of the catheter through the lumen. Such direction information can be useful not only in avoiding contact between the catheter tip and the lumen wall, but also in assisting navigation in a more general way. The navigation assistance (e.g., pressure sensing) devices as described herein are any suitable devices for use with any cannulation device or catheter or other structure (used interchangeably herein without intention of limitation) of any size, cross-sectional shape or area, and / or configuration that allows introduction and passage into a part of the body or anatomical structure, such as within a body lumen or body tube or through a body lumen or body tube. The navigation assistance devices and components as described herein are particularly suitable for placement within the wall of a flexible elongate member such as a tubular structure like a catheter.The flexible elongate member generally includes a working channel (which preferably extends axially along the length or longitudinal axis of the catheter), and navigation to the treatment site is facilitated by advancing the elongate member over a guide wire (which extends through the working channel). The working channel also enables the delivery of various therapies or other treatment devices therethrough. The navigation assist device is housed within the catheter (e.g., between the walls of the catheter) and can thus be protected from tissue pieces approaching the sensor and interfering with its operation.

[0027] As can be understood, the navigation assistance device or component (or at least a part thereof) is preferably disposed at the distal end of the flexible elongate member. In this way, the engagement between the distal end of the flexible elongate member and other objects is sensed by the navigation assistance device, information is generated, and is transmitted to the user (such as a medical professional, or other navigator of the medical device) for use in further navigation decisions. Preferably, the distal end of the flexible elongate member has sufficient flexibility to transmit the impact on its distal end to the navigation assistance device to generate appropriate information for assisting the navigation of the flexible elongate member and associated devices and apparatuses. In some embodiments, the distal end of the catheter has a proximal segment and a distal segment, and has a biasing element (such as a coil spring) therebetween. When the distal segment moves, or deflects, or otherwise deforms (such as when in contact with an object encountered by the distal end of the flexible elongate member), the distal segment translates proximally towards the proximal segment, activating the navigation assistance device or a component thereof. In some embodiments, the biasing element functions to direct a force to the navigation assistance device such as a sensing component, thereby essentially translating and / or amplifying the force to facilitate or improve the sensing. The feedback from the navigation assistance device may be directional, for example, indicating whether the dorsal side, ventral side, left side, or right side of the flexible elongate member has collided, so that the flexible elongate member can be appropriately manipulated (such as releasing the pressure on its distal end). The navigation assistance device includes at least three pressure sensors for generating information including the magnitude of the force, the orientation of the force (axial or radial force application), and the direction of the force along the periphery of the catheter (for example, the location of the load applied along the outer periphery of the catheter), or separates the sensors from other elements and includes four or more sensors for indicating the quadrants of the distal end of the flexible elongate member that has encountered another object, so that the flexible elongate member can be maneuvered to release the pressure on its distal end.

[0028] Referring now to the drawings, in the following description, it will be understood that for similar elements or components among the various illustrated embodiments, they are generally designated by the same reference numbers incremented by 100, and duplicate descriptions are omitted. Common features are identified by common reference elements, and for the sake of brevity, the descriptions of common features will generally not be repeated.

[0029] In various embodiments described herein, a catheter introduction system 100 as illustrated in FIG. 1 includes a flexible elongate member such as a catheter 110 (as noted above, the term "catheter" is used for simplicity without intended limitation). The catheter 110 has a working channel 112 that extends axially (or as referred to herein as extending along its length) through the interior thereof between a proximal end 111 and a distal end 113 of the catheter 110. The catheter 110 is formed from a sufficiently flexible material to allow for bending of the catheter 110 through a serpentine path. In some embodiments, the catheter 110 is formed from polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyether ether ketone (PEEK), or the like, or combinations thereof. In some embodiments, the catheter 110 is machined to have greater flexibility in certain regions along its axial extent. Although specifically referring to a catheter, it will be understood that any flexible elongate member capable of housing a navigation assistance device as described herein may be used.

[0030] The proximal end 111 of the catheter 110 extends to the control handle 102, through which a medical professional can operate and / or control and / or navigate and / or steer the catheter 110 (or an endoscope, or a duodenoscope, or a bronchoscope, or any other device through which the catheter 110 is conveyed to the treatment site) (such terms are used interchangeably herein for convenience, and it should not be understood as limiting that one term is used preferentially over another). Any known or publicly known control handle 102 may be used, for example, formed from a metallic material or a polymeric material, including one or more connectors (for example, for coupling other components or devices or instruments to the handle 102), ports (for example, for injecting a fluid such as a contrast agent for fluoroscopy, etc.), or other structures or components, and a control handle 102 that can accommodate a navigation assistance device as described herein may be used. It will be understood that the catheter 110 of the present disclosure is not limited by a particular handle or its configuration. As is generally understood, a medical professional uses the control handle 102, or other suitable guiding devices known or publicly known in the art, to rotate, vibrate, linearly advance, reciprocate, and / or otherwise move / guide / navigate the catheter 110 (such as through a body lumen), and more specifically, to guide the distal end 113 of the catheter 110 to the treatment site and perform procedures such as endoscopic cannulation procedures, papillotomy, sphincterotomy, urinary procedures, etc., using the catheter (for example, optionally, together with a camera, a basket, a cutting device, a laser, or other additional devices).

[0031] According to various principles of the present disclosure, the catheter 110 is formed such that a navigation assistance device extends along the wall 114 of the catheter 110 (substantially axially or longitudinally). As used herein, a navigation assistance device is understood to be a device or component or apparatus that provides information such as position information used when determining navigation (e.g., navigation determination), including the direction of navigation of the catheter 110, to a user or technician. Examples include, but are not limited to, pressure sensors and / or cameras, as will be described in more detail below. According to one aspect of the present disclosure, the wall 114 of the catheter 110 has an internal space 114s therein such that a navigation assistance device can be disposed within the wall 114 of the catheter 110. The position of the navigation assistance device within the wall of the catheter 110 keeps the working channel 112 within the catheter 110 free of obstacles so that a guide wire, cable, medical instrument, cutting instrument, other working tool, etc. can pass through the working channel 112 without interfering with the components of the navigation assistance device.

[0032] As shown in the schematic cross-sectional view of FIG. 2 (along line II-II of FIG. 1), in one embodiment, the catheter wall 114 includes an inner wall 114i and an outer wall 114e that define an internal space 114s therebetween. In one embodiment, the inner wall 114i is an inner liner, and the catheter 110 is a braided catheter having a braided element 115 that is formed, for example, to cover the inner liner (alternatively, after the formation of the braided catheter, an inner liner may be provided within the braided catheter, for example, to form a lining of the working channel 112), and is covered by an outer wall 114e in the form of an outer jacket or layer that covers the braided catheter, for example, by extrusion or the like. This is, for example, a Catheter Having A Adhesive Braid Wire Constraint And, issued on September 14, 1999, the entire disclosure of which is incorporated herein by reference. As described in Berg's U.S. Patent No. 5,951,495, titled "Method Of Manufacture" (assigned to Boston Scientific Scimed Inc.), it is known in the art. Such braiding can be beneficial in constructing the structure of the catheter while still allowing for a desired amount of flexibility for navigation purposes. The navigation assistance device can be attached within the internal space 114s of the catheter wall 114 between the inner liner and the braided catheter (alternatively, it can be attached on the inner liner before forming or disposing the braided catheter to cover the inner liner, or it may be attached to the braided catheter). In another embodiment, the catheter 110 is formed, such as by extrusion, to have a hollow wall (a double wall with a space between those double walls) that defines a working channel 112 therein. The navigation assistance device may be attached within the internal space 114s defined between the inner wall 114i and the outer wall 114e of such a hollow wall of the catheter. The distal end 113 of the catheter 110 may be compressible, and a membrane or the outer wall 114e seals and protects the internal components. For purposes of simplicity and convenience and not by way of limitation, not all of the catheter embodiments illustrated in the drawings show braided catheters.

[0033] As can be understood, the working channel 112 can be in the form of a lumen, which lumen is sized and configured to have a lumen diameter LD (as illustrated by FIG. 2 showing a cross-sectional view along line II-II of FIG. 1) such that various components and devices and instruments and materials (such terms being used interchangeably herein without intent to limit) (e.g., guide wires over which the catheter 110 and / or other devices can be advanced and guided, cutting wires, other therapeutic devices / materials, etc.) can pass through, for example, the catheter 110 to reach the treatment site. Further understood, the exterior of the catheter 110 is selected to fit within the body passageway in which the desired procedure is performed or within another tubular element (e.g., a shaft, catheter, duodenoscope, endoscope, etc.) that is navigated within the body passageway and has an outer diameter CD (as illustrated by FIG. 2 showing a cross-sectional view along line II-II of FIG. 1). Accordingly, the amount of space provided within the internal space 114s within the hollow wall 114 of the catheter 110 for arranging components is limited, and the navigation assistance devices provided within the internal space 114s of the catheter 110 are of appropriate size (both length and cross-section) and shape to fit within the internal space 114s, be properly positioned, and detect contact of the distal end 113 of the catheter 110 with body tissue or the lumen wall or detect the application of another force to the distal end 113 of the catheter 110.

[0034] An example of a navigation assistance device that uses a sensor 120 disposed within the wall 114 of a catheter, such as within the internal space 114s of the wall 114 of the catheter 110, is schematically illustrated in FIG. 3. The sensor 120 includes, but is not limited to, sensors such as optical sensors (e.g., optical fibers), inductive sensors, coil sensors, piezoelectric sensors, etc., and can be any of various pressure sensors that can detect the pressure applied to the sensor, or the contact with or collision of the sensor (such terms are used interchangeably herein and with other similar terms without intention of limitation) when hitting another object. The sensor 120 includes one or more pressure-sensitive elements 122 (schematically illustrated in FIG. 3) disposed relative to the distal end 113 of the catheter 110, and can generate a signal based on the relative movement or deformation of the sensor 120 caused, for example, by the movement or deformation of the distal end 113 of the catheter 110. In some embodiments, the sensor 120 is a highly sensitive sensor that responds to an increase in force in the range of 1 to 10 times (e.g., an increase in force in the range of 1 to 5 times) applied to the delivery catheter 110 and / or to a force in the range of about 1 to 100 g (e.g., a force in the range of 1 to 50 g), so that a collision with the distal end 113 of the catheter 110 is detected and further collisions (which may cause damage or puncture of body tissue or the lumen wall) are avoided. It will be understood that other types of sensors, such as proximity sensors, optical sensors, temperature sensors, etc., may be used instead of or in addition to the pressure sensor.

[0035] In some embodiments described in further detail below, the distal end 113 of the catheter 110 is flexible, so that if the distal end 113 collides with another object or obstacle (e.g., a tissue wall or a lumen wall), the distal end 113 moves or deflects, and such movement or deflection activates the sensor 120 to cause a collision, contact, or encounter of the distal end 113 of the catheter 110 with a body tissue (e.g., a papilla) or another object such as a lumen wall (such terms are used interchangeably herein without intention of limitation and with other similar terms) to generate a signal indicating detection of pressure on the distal end 113 of the catheter 110. Catheter sections or segments that move relative to each other may be referred to as a proximal pressure sensing segment 118 and a distal pressure sensing segment 116. Although segments 116, 118 are referred to as "pressure sensing", it will be understood that such segments are not limited to sensing changes in pressure. In some embodiments, the proximal pressure sensing segment 118 is simply the distal portion of the catheter 110, and the distal pressure sensing segment 116 is a cap element at the most distal free end of the catheter 110, providing a non-invasive or blunt end or tip to the catheter 110. Due to the inherent flexibility and / or elasticity of the wall 114 of the catheter 110, the operation of the sensor 120 can be caused when the distal end 113 of the catheter 110 collides with another object (e.g., a body tissue, a lumen wall, etc.), whereby the deformation of the catheter 110 is transmitted to the pressure sensing element 122 of the sensor 120, causing the pressure sensing element 122 to generate a signal indicating that the distal end 113 of the catheter 110 has been collided with or otherwise contacted (such terms are used interchangeably herein without intention of limitation and with other similar terms). A biasing element 130 such as a coil spring extending around the periphery of the catheter 110, or other biasing elements known or publicly known in the art, may be provided to impart flexibility and / or elasticity to the distal end 113 of the catheter 110 and function to activate the pressure sensor 120.

[0036] In some embodiments, the proximal pressure sensing segment 118 and the distal pressure sensing segment 116 are separate elements separated by a gap 117 and are movable relative to each other to operate the pressure sensor 120. The inner wall 114i may extend at least partially into the proximal pressure sensing segment 118 across the gap 117. The biasing element 130 is provided within the gap 117, provides elasticity to the distal end 113 of the catheter 110, and / or maintains the space between the distal pressure sensing segment 116 and the proximal pressure sensing segment 118 when the distal end 113 of the catheter 110 is in a rest or neutral position where no pressure is applied. In the example of the distal end 113 of the catheter 110 illustrated in FIG. 3, the distal pressure sensing segment 116 may be movably attached (e.g., axially) relative to the proximal pressure sensing segment 118 and be a separate element distal to the proximal pressure sensing segment 118. For example, the distal pressure sensing segment 116 may be in the form of a movable ring element or pressure head formed separately from the distal end of the catheter body forming the proximal pressure sensing segment 118. The distal pressure sensing segment 116 may be held in a fixed position relative to the proximal pressure sensing segment 118 so as not to separate from the proximal pressure sensing segment 118, such as by being coupled to the biasing element 130 (the biasing element 130 will similarly be coupled to the proximal pressure sensing segment 118, or to another component of the catheter 110 or delivery system). The outer wall 114e (e.g., catheter jacket) of the catheter 110 may be configured to hold the distal pressure sensing segment 116 and the proximal pressure sensing segment 118 in a fixed position as well. Alternatively or additionally, the distal pressure sensing segment 116 may be coupled to the body of the catheter 110 in another manner.

[0037] According to one aspect of the present disclosure, sensors such as pressure sensors are provided along the periphery or around or circumference of the catheter 110 (such terms are used interchangeably herein without intending limitation), such as within the internal space 114s of the catheter 110, for example to provide improved directional information to assist in the navigation of the catheter 110. In some embodiments, two or more sensors are provided along the periphery of the wall 114 of the catheter 110 to provide medical professionals with improved directional information indicating the location of a collision with the catheter wall 114. More specifically, signals from various ones of the plurality of sensors 120 can be mapped relative to the periphery of the wall 114 of the catheter 110 such that a single signal from a given sensor 120 indicates the location around the periphery of the wall 114 of the catheter 110 that encountered and contacted an obstacle. In some embodiments, at least three or four sensors 220 are provided around the periphery of the catheter 210. At least three sensors are provided to enable three-dimensional directivity (information on the X-axis, Y-axis, and Z-axis). Four or more sensors 220 can provide additional directional information regarding the X-Y plane, such as by dividing the circumference of the catheter 110 into quadrants to more specifically indicate the location of a collision with the distal end 113 of the catheter 110. In some embodiments, the sensors 120 are spaced substantially equidistant from each other. In some embodiments, the sensors 120 are correlated with specific locations around the periphery of the catheter 110 such that signals generated by an individual one of the plurality of sensors 120 can be used to indicate a specific location around the periphery or circumference of the catheter 110 that contacted another element such as a body lumen wall. More specifically, signals from the sensing elements can be compared and processed to relay directional information to the medical professional, such that the medical professional (or an automated system) can determine which region of the distal end 113 of the catheter 110 encountered another object (e.g., body tissue, lumen wall, etc.), thereby determining an appropriate direction to navigate or manipulate the distal end 113 to continue moving without further colliding with that object and instead reach the treatment site.The signal may be relayed to the medical professional navigating the catheter 110, such that the medical professional (or automated system) can determine or decide the direction in which the catheter 110 should be manipulated to pass obstacles and reach the treatment site. Such information may also be associated or correlated with the steering component or device, and the associated or correlated information is relayed to the medical professional to guide the medical professional to steer the catheter 110 in the appropriate direction to pass obstacles and reach the treatment site.

[0038] In some embodiments, the force sensed by one or more sensors 120 is transmitted proximally through the internal space 114s of the catheter 110 to, for example, a suitable control unit (e.g., by suitable wiring or by wireless means), which is accessible to a medical professional controlling the catheter 110 and has a user interface (such as a display or interface having other components for generating information signals) for communicating information useful for navigating the catheter 110. The control unit can be any control unit known in the art or known herein that is capable of processing signals from pressure sensors as described herein, and preferably also correlates such signals to locations around the catheter 110 and can communicate such signals to a medical professional or other individual or navigation controller (e.g., a computer system) navigating the catheter 110. Signals from each sensor 120 may be transmitted separately / individually to the control unit for processing. Information indicating the direction of a collision of the catheter 110 with an obstacle such as a lumen wall or tissue wall may be generated and provided to the medical professional by indicating the particular sensor that generated the signal and the relative location or position of that sensor around the circumference of the catheter 110. Since the control unit can correlate the position of the sensor(s) that generated the signal to the steering component, the medical professional can use this information to determine the direction to steer the catheter 110 and continue to advance the catheter 110 to reach the treatment site without further obstacles. The control unit may include additional navigation aids such as a six-degree-of-freedom navigation sensor for tracking the catheter in three-dimensional space. Thus, the sensors are monitored, and based on information from the sensors regarding the position where the distal end 113 of the catheter 110 encounters and contacts body tissue, lumen walls, etc., the catheter 110 can be steered towards the target area or treatment site without damaging, penetrating, or otherwise contacting further the body tissue, lumen walls, etc.Any of a variety of warnings, such as a warning or more detailed information on the screen, may indicate which side(s) of the catheter 110 was exposed to a higher pressure.

[0039] As can be appreciated, additional components of the navigation assistance device, such as a pressure transducer or pressure transmitter, wiring, a mount structure, etc., must be sized and shaped to fit within the internal space 114s within the catheter 110, and also sized and shaped to extend proximally through the catheter introduction system 100, transmit signals from the distal end 113 of the catheter 110 to the control unit, and convey desired information regarding the distal end 113 of the catheter 110 to the medical professional. Depending on the specific structure of the navigation assistance device (such as the pressure sensing component), a stabilization structure may be provided in the internal space 114s of the wall 114 of the catheter 110 to dispose and stabilize those components during the braiding process of the catheter 110. Alternatively or additionally, a mount such as a mount ring may be provided to stabilize the components of the navigation assistance device within the internal space 114s of the wall 114 of the catheter 110, and / or the space may be filled with an adhesive and / or epoxy, etc. to hold the components in place.

[0040] As described above, the sensor used in the navigation assistance catheter according to the principles of the present disclosure can be any type of pressure sensor that can sense when the distal end 113 of the catheter 110 collides with or contacts another element, or other types of sensors that provide information and / or feedback usable for navigation purposes. In some embodiments, the sensor 120 functions in response to relative movement of one or more elements (e.g., generates a signal indicating that pressure is applied thereto). For example, in the embodiments illustrated in FIGS. 4A, 4B, 5A, 5B, 6A, and 6B, the catheter 210 includes a sensor 220 in the form of one or more optical fibers 240 disposed within the wall 214 of the catheter 210. As shown in FIGS. 4A and 4B, the distal end 243 of the optical fiber 240 extends from the distal end 213 of the catheter 210 to the distal end of the proximal pressure sensing segment 218 of the catheter 210. The distal end 243 of the optical fiber 240 is at the proximal end of the gap 217 between the proximal pressure sensing segment 218 and the distal pressure sensing segment 216. A change in the gap between the distal end 243 of the optical fiber 240 and the proximal surface 216p of the distal pressure sensing segment 216 (e.g., caused by the distal end 213 of the catheter 110 and the distal pressure sensing segment 216 encountering body tissue or the lumen wall) is converted into a corresponding change in the interference pattern generated by the reflection of light from the optical fiber 240 hitting the proximal surface 216p of the distal pressure sensing segment 216. The pressure sensor 220 can determine the pressure on the distal pressure sensing segment 216, such as by measuring a change in the wavelength of the light reflected from the proximal surface 216p of the distal pressure sensing segment 216. An urging element 230, such as a coil spring extending around the periphery of the catheter 210, is provided between the distal pressure sensing segment 216 and the proximal pressure sensing segment 218 (such as within the internal space 214s of the catheter 210) to maintain the space between the distal pressure sensing segment 216 and the proximal pressure sensing segment 218 and / or impart elasticity to the distal end 213 of the catheter 210 when it is in a stationary or neutral position where no pressure is applied to the distal end 213 of the catheter 210.Segments 216 and 218 are referred to as "pressure sensing", but it will be understood that such segments are not limited to sensing changes in pressure.

[0041] To improve the navigation assistance capabilities of the sensor 220, as shown in FIGS. 5A and 5B, a plurality of sensors 220 may be provided within the wall 214 of the catheter 210. As described above, by providing three or more sensors 220, signals from the sensors 220 can generate directional information useful for facilitating the navigation of the catheter 110. To enhance the directional sensitivity, four or more sensors 220 may be provided in accordance with the principles of the present disclosure. The sensor 220 may be an optical fiber 240, as in the embodiments of FIGS. 4A and 4B.

[0042] In some embodiments, such as those illustrated in FIGS. 6A and 6B, camera 250 may be provided as a navigation assistance device in addition to, or instead of, sensor 220. According to the principles of the present disclosure, camera 250 may be provided within internal space 214s of wall 214 of catheter 210, instead of passing through working channel 212 of catheter 210. In this way, not only direct visualization for performing treatment after reaching the treatment site, but also visualization for navigation purposes can be achieved using the camera without the camera occupying valuable space within working channel 212 of catheter 210 (more space can be secured for working tools within working channel 212). Further, by disposing camera 250 within wall 214 of catheter 210, a more reliable and stable placement of camera 250 is provided during navigation through the body and when other working tools or other components pass through working channel 212 of catheter 210, because camera 250 can be isolated or shielded, or otherwise protected, and stabilized by hitting against catheter 210, since it is either moved or otherwise engages or interacts with other working tools or other components. The embodiments illustrated in FIGS. 6A and 6B show camera 250 as well as sensor 220, but it should be understood that providing only camera 250 without additional sensors can provide the desired navigation assistance in accordance with the principles of the present disclosure. Sensor 220 may be an optical fiber 240, as in the embodiments of FIGS. 4A and 4B.

[0043] As described above, as schematically illustrated in FIGS. 1A and 1B, the sensor 120 used within the catheter 110 in accordance with the principles of the present disclosure may be any sensor such as a pressure sensor suitable for use in a small space such as within the wall of the catheter 110 and suitable for high-sensitivity sensing capabilities such as when navigating within the body. Another example of the sensor 120 that may be disposed within the wall 114 of the flexible and / or elastic distal end 113 of the catheter 110 is the inductive pressure sensor 320 as illustrated in FIGS. 7A and 7B. Similar to the embodiments of FIGS. 4A, 4B, 5A, 5B, 6A, and 6B, one or more inductive pressure sensors 320 may be distributed around the periphery of the wall 314 of the catheter 310 to facilitate determination of the directionality of the force. The inductive pressure sensor 320 typically includes a coil element 324 and an inductive rod element 326 disposed within the distal end 513 of the catheter 510 and detects the pressure applied to the distal end 313 of the catheter 310. For example, in the embodiments of FIGS. 7A and 7B, movement of the distal end 313 of the catheter 310, such as as a result of the distal end 313 of the catheter 310 encountering and colliding with another object, causes relative movement of the distal pressure sensing segment 316 with respect to the proximal pressure sensing segment 318 (against the biasing force of the biasing element 310 in this embodiment), causing movement of the inductive rod element 326 with respect to the coil element 324 to generate a signal. For example, the inductive rod element 326 may extend distally from the coil element 324 and move in response to or with the movement of the distal pressure sensing segment 316 (e.g., upon contact with the proximal surface 316p of the distal pressure sensing segment 316), thereby moving with respect to the coil element 324 and generating a signal indicative of the force applied to the distal end 313 of the catheter 310.

[0044] Yet another type of sensor 120 that can be used in catheter 110 according to the principles of the present disclosure is a piezoelectric sensor 420 as illustrated in the embodiments of FIGS. 8A and 8B. As is known in the art, piezoelectric materials deform when a force is applied and generate an electrical signal indicative of such force. A collision against the distal end 413 of catheter 410 transmits a force to piezoelectric sensor 420. In some embodiments, the impact may be a direct collision against piezoelectric sensor 420, causing deformation of piezoelectric sensor 420 and generating a signal. In other embodiments, the collision results from relative movement of a distal pressure sensing segment 416 that is optionally movably separate relative to a proximal pressure sensing segment 418 (e.g., via a biasing element 430 between the distal pressure sensing segment and proximal pressure sensing segment 418 as described above with reference to other embodiments disclosed herein), generating a signal indicating that the distal end 413 of catheter 410 has collided with another object. Similar to the above-described embodiments of FIGS. 4A, 4B, 5A, 5B, 6A, 6B, 7A, and 7B, two or more piezoelectric sensors 420 are provided around the wall 414 of catheter 410 to facilitate determination of the directionality of the force and also to facilitate navigation of catheter 410 using such information. As can be appreciated, piezoelectric sensor 420 can be actuated by contact from multiple different directions. Thus, piezoelectric sensor 420 provides directional pressure sensing capabilities to catheter 410 of FIGS. 8A and 8B based not only on the position of a given actuated piezoelectric sensor 420 relative to positions along the perimeter of catheter 410, but also based on the direction of the force applied to a given actuated piezoelectric sensor 420.

[0045] Instead of a sensor 120 that extends axially to detect pressure at the distal end 113 of the catheter 110, a plurality of sensors 120 may extend radially across the distal end 513 of the catheter 510 as shown in the embodiments illustrated in FIGS. 9A and 9B. The radially extending sensor 520 may be disposed at the distal end 513 of the catheter 510 within the distal pressure sensing segment 516 of the catheter 510 without force being transmitted to the sensor 520 through an intermediate element (e.g., a biasing element 130) as shown. However, it should be understood that the proximal pressure sensing segment 518 may include a radially extending sensor 520 mounted therein, and an intermediate element such as a biasing element may be provided for force amplification purposes. When one of the sensors 520 contacts another object (e.g., when the catheter 510 is moved and hits an obstacle such as a tissue wall or a lumen wall), the sensor 520 deforms or otherwise activates to generate a signal indicating the collision therewith. The radial orientation of the sensors 520 may provide higher sensitivity to the direction information or location of the collision to the distal end 513 of the catheter 510. Any sensor such as a piezoelectric sensor and / or a strain gauge that can fit within the internal space 514s of the wall 514 of the catheter 510 and has sufficient sensitivity to forces (e.g., impact forces or bending forces) applied to the internal space 514s may be used.

[0046] (Appendix) As a preferred embodiment, the technical idea that can be grasped from the above embodiments will be described below. [Item 1] A flexible elongate member, The flexible elongate member comprises a tubular wall, the tubular wall comprising an outer tubular wall and an inner tubular wall disposed inside the outer tubular wall, the outer tubular wall and the inner tubular wall defining an internal space therebetween and defining a working channel inside the inner tubular wall, the working channel being sized and configured to permit a plurality of instruments to pass therethrough for performing a treatment on a treatment site, and the internal space and the working channel extending axially between a proximal end of the flexible elongate member and a flexible distal end of the flexible elongate member. The flexible elongate member comprises at least one navigation assistance pressure sensor disposed within the internal space at the flexible distal end of the flexible elongate member to detect deflection of the flexible distal end and generate a signal indicative of the flexible distal end of the flexible elongate member encountering an object. Flexible elongate member. [Item 2] The flexible elongate member according to item 1, wherein the at least one navigation assistance pressure sensor is a pressure sensor capable of detecting a collision of the flexible distal end of the flexible elongate member hitting an object. [Item 3] The flexible elongate member according to item 2, wherein the at least one navigation assistance pressure sensor comprises at least four sensors disposed equidistantly around the periphery of the internal space. [Item 4] The flexible elongate member according to item 1, wherein the at least one navigation assistance pressure sensor comprises one of an optical fiber, an inductive sensor, or a piezoelectric sensor. [Item 5] A flexible elongate member defining a working channel sized and configured to permit a plurality of instruments to pass therethrough for performing a treatment on a treatment site. The flexible elongate member comprises a tubular wall, the tubular wall comprising an outer tubular wall and an inner tubular wall disposed inside the outer tubular wall, the outer tubular wall and the inner tubular wall defining an internal space therebetween, and the internal space and the working channel extending axially between a proximal end of the flexible elongate member and a flexible distal end of the flexible elongate member. The flexible elongate member comprises at least one pressure sensor disposed within the internal space so as to detect deflection of the tubular wall. At least one of the outer tubular wall and the inner tubular wall defines the flexible distal end of the flexible elongate member. The at least one pressure sensor is disposed within the flexible distal end of the flexible elongate member and is configured to detect deflection of the flexible distal end. Flexible elongate member. [Item 6] The flexible elongate member according to item 5, wherein the at least one pressure sensor is a pressure sensor configured to detect a collision of the flexible distal end of the flexible elongate member against an object. [Item 7] The flexible elongate member according to item 5 or 6, wherein the at least one pressure sensor consists of one of an optical fiber, an inductive sensor, or a piezoelectric sensor. [Item 8] The flexible elongate member according to any one of items 5 to 7, wherein the flexible distal end of the flexible elongate member includes a proximal pressure sensing segment and a distal pressure sensing segment that are axially movable relative to each other. [Item 9] The flexible elongate member according to item 8, further comprising a biasing element that biases the proximal pressure sensing segment and the distal pressure sensing segment away from each other in a neutral configuration in which the flexible distal end of the flexible elongate member is not in contact with an object. [Item 10] The at least one pressure sensor is provided in the proximal pressure sensing segment, and relative movement of the distal pressure sensing segment relative to the proximal pressure sensing segment actuates the at least one pressure sensor to generate a signal, the flexible elongate member according to item 8 or 9. [Item 11] The flexible elongate member according to any one of items 1, 5 to 10, further comprising a camera within the internal space. [Item 12] The at least one pressure sensor comprises at least three sensors that provide direction information, the flexible elongate member according to any one of items 5 to 11. [Item 13] The at least one pressure sensor comprises at least four sensors that are arranged equidistantly around the periphery of the internal space, the flexible elongate member according to any one of items 5 to 12. [Item 14] A system, The system comprises a handle, The system comprises a flexible elongate member that extends axially between a proximal end coupled to the handle and a flexible distal end, the flexible elongate member comprising an outer tubular wall and an inner tubular wall disposed within the outer tubular wall, the outer tubular wall and the inner tubular wall defining a working channel within the inner tubular wall, the working channel being sized and configured to permit a plurality of instruments to pass therethrough for performing a procedure on a treatment site, and defining an internal space between the outer tubular wall and the inner tubular wall, The system comprises at least one navigation assistance pressure sensor disposed within the internal space at the flexible distal end of the flexible elongate member to detect deflection of the flexible distal end and generate a signal indicating that the flexible distal end of the flexible elongate member has encountered an object. At least one of the outer tubular wall and the inner tubular wall defines the flexible distal end of the flexible elongate member. The at least one navigation assistance pressure sensor is disposed within the flexible distal end of the flexible elongate member. System. [Item 15] The system according to item 14, further comprising a control unit that processes a signal from the at least one navigation assistance pressure sensor and indicates direction information regarding a collision of the flexible distal end of the flexible elongate member against an object. It should be understood by those skilled in the art that the description herein is only an illustrative example of embodiments and is not intended to limit the broader aspects of the present disclosure. The foregoing disclosure has described a (e.g., pressure sensing) tip having flexibility of a catheter, but it should be understood that the principles described herein may also be applied to other devices having a lumen therethrough. Embodiments of the present disclosure can be configured to be used with medical devices and systems (e.g., endoscopic accessories and / or guidewires inserted through a duodenoscope) for selectively cannulating the common bile duct (CBD) or pancreatic duct (PD) during an endoscopic retrograde cholangiopancreatography (ERCP) procedure. However, it should be understood that embodiments of the present disclosure can also be used in various other medical procedures that require navigating one or more accessories through a tube, lumen, or vasculature, including, for example, interventional radiology procedures, balloon angioplasty procedures, thrombolysis procedures, angiography procedures, lung procedures, and the like. The medical devices of the present disclosure are not limited to a particular type of endoscope such as a duodenoscope, and may include various medical devices for accessing body passages, such as, for example, catheters, duodenoscopes, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like. Further, the disclosed medical devices and systems can be inserted via multiple different access points and approaches, for example, percutaneously, endoscopically, laparoscopically, or some combination thereof.

[0047] The foregoing description of the specification has broad applications and is presented for purposes of illustration and explanation and is not intended to limit the disclosure to one or more of the 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 concepts, 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, ratios, and by other elements, materials, and components without departing from its concepts, spirit, scope, or characteristics. For example, various features of the disclosure can be grouped together in one or more aspects, embodiments, or configurations to smooth the disclosure. However, it should be understood that the various features of a particular aspect, embodiment, or configuration of the disclosure can be combined in alternative aspects, embodiments, or configurations. The disclosure is presented with respect to embodiments, but it should be understood that the various distinct features of the subject matter need not all be present to achieve at least some of the desired characteristics and / or benefits of the subject matter or such individual features. Those skilled in the art will understand that the disclosure can be used with many modifications or with structures, arrangements, ratios, materials, components, and other modifications used in the practice of the disclosure that are particularly adapted to specific environments and operating requirements without departing from the principles, spirit, or scope 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 the elements can be reversed or otherwise changed, and the size or dimensions of the elements can be changed. Similarly, although operations, actions, or steps are described in a particular order, this should not be understood to require that such a particular order is necessary to achieve a desired result or that all operations, actions, or steps should be performed. In addition, 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 a desired result.Accordingly, the presently disclosed embodiments are to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the foregoing, the individual features of any embodiment may be used separately or in combination with the features of that or any other embodiment and may be claimed, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0048] In the foregoing description and the following claims, the following matters will be understood. As used herein, the phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that function as both conjunctive and disjunctive. Terms such as “a,” “an,” “the,” “first,” “second,” etc. do not exclude a plurality. For example, an entity referred to by the term “a” or “an” refers to one or more of that entity when used herein. Thus, the terms “a” (or “an”), “one or more,” and “at least one” can be used interchangeably herein. All references to directions (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to assist the reader's understanding of the present disclosure, and / or to distinguish the regions of associated elements from one another, and do not limit the associated elements, particularly with respect to the position, orientation, or use of the present disclosure. References to connection (e.g., attached, coupled, connected, and joined) should be construed broadly and can include intermediate members between sets of elements and relative movement between the elements, unless otherwise indicated. Thus, a reference to connection does not necessarily imply that two elements are directly connected and in a fixed relationship to each other. References to identification (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority and are used to distinguish one feature from another. The following claims are incorporated by reference into this “Detailed Description of the Invention,” and each claim stands on its own as a separate embodiment of the present disclosure. Reference numerals in the claims are provided merely as examples for clarity and should not be construed as limiting the claims in any way.

[0049] The following claims are incorporated by reference into this "Detailed Description of the Invention", and each claim stands on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises" and "comprising" do not exclude the presence of other elements or steps. Additionally, although individual features may be included in different claims, these may, in some cases, be advantageously combined, and inclusion in different claims does not imply that a combination of features is not possible and / or not advantageous. Moreover, a singular reference does not exclude a plurality. Terms such as "a", "an", "the", "first", "second", etc. do not exclude a plurality. The reference signs in the claims are provided merely as examples for clarity and should not be construed as limiting the claims in any way.

Claims

【Claim 1】 The apparatus or system described in this specification.

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