DEVICES AND SYSTEMS FOR ENDOSCOPIC PROCEDURES - Patent application

Abstract

A navigation-aiding flexible elongate member, a navigation-aiding system, and a navigation-aiding method for use in navigating to a treatment site within a body. A navigation-aiding sensor, such as an optical fiber, an inductive sensor, a piezoelectric sensor, or a camera, is provided within a wall of the flexible elongate member so as not to occupy space within a working channel defined by and through the flexible elongate member. When the distal end of the flexible elongate member encounters an obstacle / another object (e.g., body tissue or a lumen wall), the navigation-aiding sensor generates a signal indicative of such encounter. Such a signal is converted (e.g., by a control unit) into information usable to navigate the flexible elongate member away from the obstacle and toward the treatment site.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of catheters, and more particularly to catheters having navigational aid capabilities, such as navigational aid components or devices for use within the body. [Background technology]

[0002] In various procedures, such as gastrointestinal procedures such as cannulation, physicians or other medical professionals are required to navigate complex anatomical structures with a limited amount of feedback (visual, tactile, etc.). For example, the target body passageway may be oriented at a difficult angle to the endoscopic accessory, have a very small or sealed opening, or contain tortuous anatomical structures, obstructions, and / or benign or malignant structures. The medical professional may take multiple attempts to achieve successful cannulation. Furthermore, the likelihood of trauma to tissues including or surrounding the target body passageway increases with the number of cannulation attempts.

[0003] Thus, 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 aid in understanding, as those skilled in the art will appreciate that various aspects and features of the disclosure can each be used advantageously separately in some cases and in combination with other aspects and features of the disclosure in other cases. No limitation as 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] In accordance with various principles of the present disclosure, flexible elongate members, such as navigation-assisted catheters and systems, include various components capable of determining the position of the catheter relative to another object (e.g., a tissue wall or a lumen wall) and communicating such information for use in navigating, directing, maneuvering, etc., the catheter. In some embodiments, the flexible elongate members include navigation-assisted sensors that generate signals that are usable or convertible into usable information in navigating the flexible elongate members, for example, within a body cavity or lumen. Such flexible elongate members and associated systems are useful in navigating the bile duct, pancreatic duct, or any lumen, and are potentially useful for use in any of a variety of procedures, such as gastrointestinal, urological, reproductive, circulatory, respiratory, pulmonary, etc. Although the present disclosure may refer to navigation of the gastrointestinal system and / or bile duct as examples, 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 having an outer wall and an 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 the at least one sensor 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 providing directional information, hi some embodiments, the at least one pressure sensor comprises at least four pressure sensors equally spaced around a perimeter of the interior space.

[0008] In some embodiments, at least one sensor detects the impact of the distal end of the flexible elongate member striking an object. In some embodiments, the at least one sensor comprises one of a fiber optic, 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 one another. In some embodiments, the flexible elongate member further includes a biasing element that biases the proximal and distal pressure sensing segments apart in a neutral configuration in which the distal end of the flexible elongate member is not colliding 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 with respect to the proximal pressure sensing segment activates the at least one pressure sensor to generate a signal, hi some embodiments, the signal indicates that the distal end of the flexible elongate member has impacted an object.

[0011] In some embodiments, the at least one sensor comprises at least three pressure sensors spaced apart to indicate a directionality of an impact on 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 the proximal pressure sensing segment spaced from the proximal face of the distal pressure sensing segment, and relative movement of the distal pressure sensing segment with respect to the proximal pressure sensing segment causes a change in an interference pattern produced by reflection of light from the optical fiber hitting the proximal face of the distal pressure sensing segment, which indicates pressure on the distal end of the flexible elongate member.

[0012] In some embodiments, the flexible elongate member further comprises a camera within the interior space. In various embodiments described or otherwise within the scope of the present disclosure, a flexible elongate member is disclosed, the flexible elongate member having an outer wall and an inner wall defining an interior space therebetween and 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 navigational aid sensor disposed within the interior space at the distal end of the flexible elongate member and generating a signal indicating that the distal end of the flexible elongate member has encountered an object.

[0013] In some embodiments, the at least one navigational aid sensor is a pressure sensor capable of detecting collision of the distal end of the flexible elongate member against an object. In some embodiments, the at least one pressure sensor includes at least three pressure sensors that provide directional information. In some embodiments, the at least one pressure sensor includes at least four pressure sensors equally spaced around a perimeter of the interior space.

[0014] In some embodiments, the at least one navigational aid sensor comprises one of a fiber optic, an inductive sensor, a piezoelectric sensor, or a camera. Other sensors, such as proximity sensors, light sensors, temperature sensors, etc., are also within the scope of this disclosure.

[0015] In one aspect, the present subject matter is directed to a navigation aid system, the navigation aid system including a handle that houses a navigation device, the navigation aid system including a flexible elongate member extending axially between a proximal end coupled to the handle and a distal end, the flexible elongate member including an outer wall and an inner wall defining an interior space therebetween and defining a working channel therein, the navigation aid system including at least one navigation aid sensor disposed within the interior space at the distal end of the flexible elongate member to generate a signal indicating that the distal end of the flexible elongate member has encountered an object, at least one of the outer wall and the inner wall defines a distal end of the flexible elongate member, and the at least one navigation aid sensor is disposed within the distal end of the flexible elongate member.

[0016] In some embodiments, the at least one navigational aid sensor comprises one of a fiber optic, an inductive sensor, a piezoelectric sensor, or a camera. Other sensors, such as proximity sensors, light sensors, temperature sensors, etc., are also within the scope of this disclosure.

[0017] In some embodiments, the navigational aid system further comprises a control unit that processes signals from the at least one navigational aid sensor to indicate directional information regarding the impact of the distal end of the flexible elongate member against the object.

[0018] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, the scope of the claimed invention being set forth in the appended claims. Non-limiting embodiments of the present disclosure are 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, order and relative sizes reflected in the figures within the drawings may vary. For example, devices may be enlarged so that details are discernible, but are intended to be reduced in relation to, for example, fitting within a working channel of a delivery catheter or endoscope. In the figures, identical, nearly identical or equivalent elements are typically represented by the same characters, and similar elements are typically designated by similar reference numbers that differ by 100, and redundant descriptions are omitted. For the sake of clarity and conciseness, not every element is labeled in every figure, nor every element of each embodiment is shown unless illustration is 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 accompanying drawings, in which like elements are designated with like reference characters and in which: [Brief description of the drawings]

[0020] [Figure 1] 1 is an elevational view of a system for navigating complex anatomical structures, according to an aspect of the present disclosure. [Diagram 2] FIG. 2 is a cross-sectional view of the system of FIG. 1 taken along line II-II. [Diagram 3] 2 is an enlarged isolated perspective view of the distal end of the catheter of the system of FIG. 1, with navigational aid components illustrated diagrammatically. [Figure 4A] 2 is a cross-sectional view along the longitudinal axis of one example of an embodiment of a distal end of a catheter that may be used in the system of FIG. 1. [Figure 4B] FIG. 4B is a cross-sectional view of the embodiment of FIG. 4A taken along line IV-IV. [Figure 5A] 2 is a cross-sectional view along the longitudinal axis of one example of an embodiment of a distal end of a catheter that may be used in the system of FIG. 1. [Figure 5B] 5B is a cross-sectional view of the embodiment of FIG. 5A taken along line VV. [Figure 6A]2 is a cross-sectional view along the longitudinal axis of one example of an embodiment of a distal end of a catheter that may be used in the system of FIG. 1. [Figure 6B] FIG. 6B is a cross-sectional view of the embodiment of FIG. 6A taken along line VI-VI. [Figure 7A] 2 is a cross-sectional view along the longitudinal axis of one example of an embodiment of a distal end of a catheter that may be used in the system of FIG. 1. [Figure 7B] FIG. 7B is a cross-sectional view of the embodiment of FIG. 7A taken along line VII-VII. [Figure 8A] 2 is a cross-sectional view along the longitudinal axis of one example of an embodiment of a distal end of a catheter that may be used in the system of FIG. 1. [Figure 8B] FIG. 8B is a cross-sectional view of the embodiment of FIG. 8A taken along line VIII-VIII. [Figure 9A] 2 is a cross-sectional view along the longitudinal axis of one example of an embodiment of a distal end of a catheter that may be used in the system of FIG. 1. [Figure 9B] FIG. 9B is a cross-sectional view of the embodiment of FIG. 9A taken along line IX-IX. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the disclosure is not limited to the specific embodiments described, and may therefore vary. All devices, systems, and methods discussed herein are examples of devices, systems, and / or methods implemented according to one or more principles of the disclosure. Each example embodiment is provided for illustration purposes, and is merely an example, not the only way to implement these principles. Thus, references to elements, structures, or features in the drawings should be understood as references to example embodiments of the disclosure, and not as limiting the disclosure to the particular elements, structures, or features shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present 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 present subject matter encompasses such modifications and variations that come within the scope of the appended claims and their equivalents.

[0022] It will be understood that the present disclosure is described in this application at various levels of detail. In certain instances, details that are not necessary for one of ordinary skill in the art to understand the present disclosure or that would make other details difficult to appreciate may be omitted. The terms used herein are for the purpose of describing certain embodiments only and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by those of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0023] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional, clinician, technician, operator, or physician, such terms are used interchangeably without any limitation or otherwise intended) such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery), and "distal" refers to a direction or location furthest from a user such as when using the device (e.g., when introducing the device into a patient or during implantation, placement, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means at least approximately bisecting a center point, and "central axis" means, with respect to an opening, a line that at least approximately bisects a center 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] Various therapeutic devices, instruments, etc. may be delivered via a delivery device, which generally includes a flexible elongate member having one or more working channels extending substantially longitudinally (axially) between the proximal and distal ends of the delivery device. It is generally beneficial for the delivery device to be steerable, and the delivery device may have multiple distinct regions of differing flexibility or stiffness to facilitate steerability. The delivery device and / or its associated overtube may be made of any suitable biocompatible material known to those skilled in the art and flexible enough to traverse non-linear or tortuous anatomical structures. Such materials include, but are not limited to, rubber, silicone, synthetic plastics, stainless steel, metal-polymer composites; metal alloys of nickel, titanium, copper cobalt, vanadium, chromium, and iron; superelastic or shape memory materials such as Nitinol (nickel-titanium alloy); and multiple distinct layers made up of multiple different materials and reinforcements. Such materials may be made of or coated with polymeric or lubricious materials to enable or facilitate passage of the delivery device therethrough. In some embodiments, the working channel may be made of or coated with a polymeric or lubricious material to facilitate passage of the introduced medical instrument(s) through the working channel(s).

[0025] It is commonly recognized that accurate and consistent placement of devices such as sphincterotomes or papillae tomes for proper cannulation is difficult. Numerous rotations of the delivery device are required to navigate through tortuous body lumens, such as the tortuous pathways in the intestine. As can be appreciated, medical professionals may inadvertently advance the tip of the delivery device or flexible elongate member or catheter or cannula or other device or instrument (these terms are used interchangeably herein, without limitation, and "catheter" is used generally for simplicity, without intended limitation) against the wall of the lumen, rather than continuing to advance it through the lumen. Such advancement may irritate the tissue or even puncture the wall, leading to further complications. Similarly, due to the different anatomy of each patient, there is not always a clear access path to the bile or pancreatic duct through the papilla or, for example, in pulmonary navigation. Through trial and error, the cannula may be inserted and advanced against the papilla, attempting to identify the access location therethrough.

[0026] According to one aspect of the present disclosure, in cannulation procedures where proper and careful guidance of a cannula or catheter or scope (or other component, such terms are used interchangeably herein without any limitation) is desired to reach a treatment site without affecting tissue along the way, it is desirable to exert minimal to zero pressure on the distal end of the catheter. According to the present disclosure, a navigational aid sensor is provided at the distal tip of the delivery device or flexible elongate member or catheter (or other component having a lumen therethrough, such terms are used interchangeably herein without any limitation) to provide feedback to the medical professional so that the medical professional knows if the catheter tip has encountered a luminal wall and can stop the advancement of the catheter to avoid damaging or puncturing the tissue and / or luminal wall. Any type of sensor may be used, such as pressure sensors, proximity sensors, optical sensors, temperature sensors, etc., known or known to those skilled in the art suitable for use in body passageways, and / or sensors of suitable size and dimensions, and / or sensors capable of sensitive sensing. For example, fiber optic sensors, inductive sensors, or piezoelectric sensors may be used. In some embodiments, the sensor is configured to provide directional information to the medical professional to assist in steering the catheter through the lumen. Such directional information may be useful not only to avoid contact between the catheter tip and the lumen wall, but also to assist in navigation in a more general manner. A navigation aid (e.g., pressure sensing) device as described herein may be any suitable device for use with any cannulation device or catheter or other structure (used interchangeably herein without intended limitation) of any size, cross-sectional shape or area, and / or configuration that allows for introduction and passage into a portion of the body or anatomical structure, such as in or through a body lumen or vessel. Navigation aids and components as described herein are particularly suited for placement within the wall of a flexible elongate member, such as a tubular structure, such as a catheter.The flexible elongate member generally includes a working channel (preferably extending axially along the length or longitudinal axis of the catheter) to facilitate navigation to the treatment site by advancing the elongate member over a guidewire (which extends through the working channel). The working channel also allows for the delivery of various therapies or other treatment devices therethrough. Because the navigational aid is contained within the catheter (e.g., between the walls of the catheter), tissue debris may be prevented from approaching the sensor and interfering with its operation.

[0027] As can be appreciated, the navigational aid or component (or at least a portion thereof) is preferably disposed at the distal end of the flexible elongate member. In this manner, engagement of the distal end of the flexible elongate member with another object will be sensed by the navigational aid and information will be generated and communicated to a user (such as a medical professional or other navigator of the medical device) for use in further navigational decisions. Preferably, the distal end of the flexible elongate member is flexible enough to transmit an impact to its distal end to the navigational aid to generate appropriate information to aid in the navigation of the flexible elongate member and associated instruments and devices. In some embodiments, the distal end of the catheter has a proximal segment and a distal segment with a biasing element (e.g., a coil spring) therebetween. When the distal segment moves, or deflects, or otherwise deforms (such as upon contact with an object encountered by the distal end of the flexible elongate member), the distal segment translates proximally towards the proximal segment, actuating the navigational aid or a component thereof. In some embodiments, the biasing element functions to direct the force to a navigational aid, such as a sensing component, and in so doing essentially translates and / or amplifies the force to facilitate or enhance its sensing. Feedback from the navigational aid may be directional, for example indicating whether the dorsal side, ventral side, left side, or right side of the flexible elongate member has been struck, so that the flexible elongate member can be appropriately steered (e.g., releasing pressure on its distal end). The navigational aid may include at least three pressure sensors to generate information including the magnitude of the force, the attitude of the force (axial or radial application of force), and the direction of the force along the circumference of the catheter (e.g., the location of the load applied along the circumference of the catheter), or four or more sensors to separate the sensors from other elements and indicate the quadrant of the distal end of the flexible elongate member that encountered another object, so that the flexible elongate member can be steered to release pressure on its distal end.

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

[0029] In various embodiments described herein, a catheter introduction system 100 as illustrated in FIG. 1 comprises a flexible elongate member such as a catheter 110 (as mentioned above, the term "catheter" is used for simplicity and not for limitation) having a working channel 112 extending through its interior along its length between a proximal end 111 of the catheter 110 and a distal end 113 of the catheter 110 (alternatively referred to herein as extending axially). The catheter 110 is formed from a material that is sufficiently flexible to allow bending of the catheter 110 through a tortuous path. In some embodiments, the catheter 110 is formed from polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), polyetheretherketone (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 a catheter is specifically mentioned, it will be understood that any flexible elongate member capable of housing a navigational aid as described herein may be used.

[0030] The proximal end 111 of the catheter 110 extends to a control handle 102 through which a medical professional can manipulate and / or control and / or navigate and / or steer the catheter 110 (or an endoscope, or duodenoscope, or bronchoscope, or other device through which the catheter 110 is delivered to a treatment site) (such terms are used interchangeably herein for convenience, and the use of one term over another should not be understood as limiting). Any known or known control handle 102 may be used, such as a control handle 102 formed from a metallic or polymeric material, including one or more connectors (e.g., for coupling other components or devices or instruments to the handle 102), ports (e.g., for injecting fluids such as contrast agents, for fluoroscopy, etc.), or other structures or components, and capable of accommodating navigational aids as described herein, it being understood that the catheter 110 of the present disclosure is not limited by a particular handle or configuration thereof. As is generally understood, a medical professional may use the control handle 102, or other suitable guidance device known or known in the art, to rotate, oscillate, linearly advance, reciprocate, and / or otherwise move / guide / navigate (such as through a body lumen) the catheter 110, and more specifically, to guide the distal end 113 of the catheter 110 to a treatment site and perform a procedure such as an endoscopic cannulation procedure, papillotomy, sphincterotomy, urinary procedure, etc. utilizing the catheter (e.g., optionally with a camera, basket, cutting device, laser, or other additional device).

[0031] In accordance with various principles of the present disclosure, the catheter 110 is formed such that the navigational aid extends (generally axially or longitudinally) along the wall 114 of the catheter 110. As used herein, a navigational aid shall be understood as a device or component or apparatus that provides a user or technician with information, such as positional information, for use in determining navigation (e.g., navigational determination), including the direction of navigation of the catheter 110. Examples include, but are not limited to, pressure sensors and / or cameras, as described in more detail below. In accordance with one aspect of the present disclosure, the wall 114 of the catheter 110 has an interior space 114s therein such that the navigational aid may be disposed within the wall 114 of the catheter 110. The location of the navigational aid within the wall of the catheter 110 is such that the working channel 112 remains clear so that guidewires, cables, medical instruments, cutting instruments, other working tools, and the like, may pass through the working channel 112 in the catheter 110 without interfering with components of the navigational aid.

[0032] As illustrated 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 defining an interior 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 formed, for example, over the inner liner (alternatively, an inner liner may be provided within the braided catheter after formation of the braided catheter, for example to form a lining of the working channel 112), and covered, such as by extrusion, by an outer wall 114e, such as in the form of an outer jacket or layer over the braided catheter, as known in the art, as described, for example, in U.S. Patent No. 5,951,495 to Berg, entitled Catheter Having A Adhesive Braid Wire Constraint And Method Of Manufacture, issued September 14, 1999, and assigned to Boston Scientific Scimed Inc., which is incorporated herein by reference in its entirety. Such braiding can be beneficial in building the structure of the catheter while still allowing a desired amount of flexibility for navigation purposes. The navigational aid may be mounted in the interior space 114s of the catheter wall 114 between the inner liner and the braided catheter (and may optionally be mounted on the inner liner prior to forming or placing the braided catheter over the inner liner, or may be mounted to the braided catheter). In another embodiment, the catheter 110 is formed, such as by extrusion, to have a hollow wall (double-walled with a space between the double walls) that defines a working channel 112 therein. The navigational aid may be mounted in the interior space 114s defined between the inner wall 114i and the outer wall 114e of such a catheter's hollow wall 114. The distal end 113 of the catheter 110 may be compressible, with a membrane or outer wall 114e sealing and protecting the internal components.For purposes of simplicity and convenience, and not intended to be limiting, the catheter embodiments illustrated in the drawings do not all depict braided catheters.

[0033] As can be appreciated, the working channel 112 can be in the form of a lumen that is sized and configured to have a lumen diameter LD (as illustrated by FIG. 2, which shows a cross-sectional view along line II-II of FIG. 1) selected to allow various components and devices and instruments and materials (such terms are used interchangeably herein without limitation) (e.g., a guidewire over which the catheter 110 and / or other devices may be advanced and guided, a cutting wire, other therapeutic devices / materials, etc.) to pass through the catheter 110, for example, to a treatment site. As can be further appreciated, the exterior of the catheter 110 has an outer diameter CD (as illustrated by FIG. 2, which shows a cross-sectional view along line II-II of FIG. 1) selected to fit within the body passageway where the desired procedure will occur or within another tubular element (e.g., a shaft, catheter, duodenoscope, endoscope, etc.) that will be navigated within the body passageway. Thus, the amount of space provided within the interior space 114s within the hollow wall 114 of the catheter 110 for positioning components is limited, and the navigational aid provided within the interior space 114s of the catheter 110 is of an appropriate size (both length and cross-section) and shape to fit within the interior space 114s, be properly positioned, and detect contact between the distal end 113 of the catheter 110 and body tissue or a lumen wall, or detect the application of another force to the distal end 113 of the catheter 110.

[0034] One example of a navigational aid utilizing a sensor 120 disposed within the wall 114 of the catheter 110, such as within an interior space 114s of the wall 114, is illustrated generally in FIG. 3. The sensor 120 may be any of a variety of pressure sensors capable of detecting pressure applied to, or contact with, or impact of, another object (such terms are used interchangeably herein, without limitation, with each other and with other similar terms), including, but not limited to, optical (e.g., fiber optic), inductive, coil, piezoelectric, and other sensors, as described in more detail below. The sensor 120 may include one or more pressure-sensitive elements 122 (schematically illustrated in FIG. 3) disposed relative to the distal end 113 of the catheter 110 and generate a signal based on relative movement or deformation of the sensor 120, for example, caused by 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 a 1-10x force increase (e.g., a 1-5x force increase) on the delivery catheter 110 and / or responds to about 1-100 g of force (e.g., 1-50 g of force) such that an impact on the distal end 113 of the catheter 110 is detected and further impact (which may cause damage or puncture of body tissue or the lumen wall) is avoided. It will be appreciated that other types of sensors, such as proximity sensors, optical sensors, temperature sensors, etc., may be used instead of or in addition to a pressure sensor.

[0035] In some embodiments, described in more detail below, the distal end 113 of the catheter 110 is flexible such that when the distal end 113 strikes 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 generate a signal indicative of a detection of pressure on the distal end 113 of the catheter 110, such as caused by the distal end 113 of the catheter 110 colliding with, or contacting, or encountering, another object, such as a body tissue (e.g., a nipple) or a lumen wall (such terms are used interchangeably herein with each other and with other similar terms, without any limitation intended). The 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 the segments 116, 118 are referred to as "pressure sensitive," 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 an atraumatic or blunt end or tip to the catheter 110. The inherent flexibility and / or resilience of the wall 114 of the catheter 110 can cause actuation of the sensor 120, such as when the distal end 113 of the catheter 110 impacts another object (e.g., body tissue, a lumen wall, etc.), thereby transmitting deformation of the catheter 110 to a pressure sensitive element 122 of the sensor 120, causing the pressure sensitive element 122 to generate a signal indicative that the distal end 113 of the catheter 110 has been impacted or otherwise contacted (such terms are used interchangeably herein with each other and other similar terms, without any limitation intended). A biasing element 130, such as a coil spring extending around the circumference of the catheter 110, or other biasing element as known or known in the art, may be provided to impart flexibility and / or resilience 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 one another to actuate the pressure sensor 120. The inner wall 114i may extend across the gap 117 and at least partially into the proximal pressure sensing segment 118. The biasing element 130 may be disposed within the gap 117 to provide resiliency to the distal end 113 of the catheter 110 and / or maintain a 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 with no pressure applied to it. In the example of the distal end 113 of the catheter 110 illustrated in FIG. 3, the distal pressure sensing segment 116 may be a separate element that is movably attached (e.g., axially) relative to the proximal pressure sensing segment 118 and 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 therefrom, such as by being coupled to a biasing element 130 (which would 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 of the catheter 110 (e.g., a catheter jacket) may be configured to similarly hold the distal pressure sensing segment 116 and the proximal pressure sensing segment 118 in a fixed position. 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 disclosure, sensors, such as pressure sensors, are provided along the periphery or circumference or circumference (such terms are used interchangeably herein without any limitation) of the catheter 110, such as within the interior space 114s of the catheter 110, for example to provide enhanced directional information to aid in 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 the medical professional with enhanced directional information indicating the location of an impingement on the catheter wall 114. More specifically, signals from various ones of the sensors 120 may be mapped relative to the periphery of the wall 114 of the catheter 110 such that a signal from a given sensor 120 indicates the location around the periphery of the wall 114 of the catheter 110 where an obstacle was encountered and contacted. 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 allow for three-dimensional orientation (X-axis, Y-axis, Z-axis information). Four or more sensors 220 provide additional directional information with respect to the XY plane, such as by dividing the circumference of the catheter 110 into quadrants that can be used to more specifically indicate the location of an impact on the distal end 113 of the catheter 110. In some embodiments, the sensors 120 are spaced substantially equidistant from one another. In some embodiments, the sensors 120 are correlated with specific locations around the circumference of the catheter 110 such that a signal generated by an individual one of the multiple sensors 120 can be used to indicate a specific location around the circumference or circumference of the catheter 110 that has 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 a medical professional so that the medical professional (or an automated system) can determine which area of ​​the distal end 113 of the catheter 110 has encountered another object (e.g., body tissue, a lumen wall, etc.) and thereby determine the appropriate direction in which to navigate or steer the distal end 113 so as not to further collide with that object but instead continue to move to reach the treatment site.The signals may be relayed to a medical professional navigating catheter 110 so that the medical professional (or automated system) can determine or decide in which direction to steer catheter 110 to pass through obstacles and reach the treatment site. Such information may also be associated or correlated with steering components or devices, and the associated or correlated information is relayed to the medical professional to guide the medical professional to steer catheter 110 in the appropriate direction to pass obstacles and reach the treatment site.

[0038] In some embodiments, the forces sensed by one or more sensors 120 are transmitted proximally through the interior space 114s of the catheter 110 (e.g., by suitable wiring or by wireless means) to a suitable control unit or the like that is accessible to a medical professional controlling the catheter 110 and has a user interface (such as a display or interface, having other components that generate 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 the pressure sensors as described herein, and preferably also capable of correlating such signals to locations around the catheter 110 and communicating 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. By indicating the particular sensor that generated a signal and the relative location or position of that sensor around the circumference of the catheter 110, information may be generated and provided to the medical professional indicating the direction of impact of the catheter 110 with an obstacle, such as a lumen wall or tissue wall. The control unit may correlate the location of the sensor(s) that generated the signal with the steering components so that the medical professional can use this information to determine a direction to steer the catheter 110 and continue to advance the catheter 110 to reach the treatment site without further obstruction. The control unit may include further 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 location where the distal end 113 of the catheter 110 encountered and contacted body tissue, lumen walls, etc., the catheter 110 may be steered toward the target area or treatment site without damaging, penetrating, or otherwise further contacting body tissue, lumen walls, etc.Any of a variety of alerts, such as an on-screen warning or more detailed information, may indicate which side or sides of the catheter 110 are exposed to higher pressure.

[0039] As can be appreciated, additional components of the navigational aid, such as pressure transducers or transmitters, wiring, mounting structures, etc., must be sized and shaped to fit within the interior space 114s within the catheter 110 and extend proximally through the catheter introducer system 100 to communicate signals from the distal end 113 of the catheter 110 to the control unit and to communicate desired information about the distal end 113 of the catheter 110 to the medical professional. Depending on the specific structure of the navigational aid (such as pressure sensing components), stabilizing structures may be provided to position and stabilize those components in the interior space 114s of the wall 114 of the catheter 110 during the braiding process of the catheter 110. Alternatively or additionally, mounts such as mounting rings may be provided to stabilize the navigational aid components within the interior space 114s of the wall 114 of the catheter 110 and / or the space may be filled with adhesive and / or epoxy or the like to hold the components in place.

[0040] As mentioned above, the sensor used in the navigational aid catheter according to the principles of the present disclosure can be any type of pressure sensor capable of sensing when the distal end 113 of the catheter 110 hits or contacts another element, or other type of sensor that provides information and / or feedback usable for navigational purposes. In some embodiments, the sensor 120 functions in response to the relative movement of one or more elements (e.g., generates a signal indicative of the pressure being applied thereto). For example, in the embodiment illustrated in Figures 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 illustrated in Figures 4A and 4B, the distal end 243 of the optical fiber 240 extends to the distal end of the proximal pressure sensing segment 218 of the catheter 210 at the distal end 213 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 face 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 a lumen wall) translates into a corresponding change in an interference pattern created by the reflection of light from the optical fiber 240 off the proximal face 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 off the proximal face 216p of the distal pressure sensing segment 216. A biasing element 230, such as a coil spring extending around the circumference of the catheter 210, may be provided between the distal pressure sensing segment 216 and the proximal pressure sensing segment 218 (e.g., within the internal space 214s of the catheter 210) to maintain a space between the distal pressure sensing segment 216 and the proximal pressure sensing segment 218 when the distal end 213 of the catheter 210 is in a rest or neutral position where no pressure is applied to the distal end 213 of the catheter 210 and / or to provide elasticity to the distal end 213 of the catheter 210.Although segments 216, 218 are referred to as "pressure sensitive," it will be understood that such segments are not limited to sensing changes in pressure.

[0041] To improve the navigational aiding capabilities of the sensor 220, multiple sensors 220 may be provided within the wall 214 of the catheter 210, as illustrated in Figures 5A and 5B. As discussed above, providing more than two sensors 220 allows signals from the sensors 220 to generate directional information useful for facilitating navigation of the catheter 110. To increase 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 embodiment of Figures 4A and 4B.

[0042] 6A and 6B, a camera 250 may be provided as a navigational aid in addition to or in place of the sensor 220. In accordance with the principles of the present disclosure, the camera 250 may be provided within the interior space 214s of the wall 214 of the catheter 210 instead of passing through the working channel 212 of the catheter 210. In this manner, visualization for navigation purposes, as well as direct visualization for reaching and performing treatment at the treatment site, may be achieved using the camera without the camera taking up valuable space within the working channel 212 of the catheter 210 (allowing more room for working tools within the working channel 212). Additionally, positioning the camera 250 within the wall 214 of the catheter 210 provides a more reliable and stable positioning of the camera 250 during navigation through the body and as other working tools or other components pass through the working channel 212 of the catheter 210, since the camera 250 is isolated or shielded or otherwise protected from being moved or otherwise engaging or interacting with other working tools or other components, and can be stabilized against the catheter 210. Although the embodiment illustrated in Figures 6A and 6B shows the camera 250 as well as the sensor 220, it should be understood that the provision of only the camera 250 without additional sensors can provide the desired navigational assistance in accordance with the principles of the present disclosure. The sensor 220 may be an optical fiber 240, as in the embodiment of Figures 4A and 4B.

[0043] As mentioned above, as illustrated generally in Figures 1A and 1B, the sensor 120 used in the catheter 110 according to the principles of the present disclosure may be any sensor, such as a pressure sensor, suitable for use in small spaces, such as within the wall of the catheter 110, and for sensitive sensing capabilities, such as when navigating within the body. Another example of a sensor 120 that may be disposed within the wall 114 of the flexible and / or resilient distal end 113 of the catheter 110 is an inductive pressure sensor 320, as illustrated in Figures 7A and 7B. Similar to the embodiments of Figures 4A, 4B, 5A, 5B, 6A, and 6B, one or more inductive pressure sensors 320 may be distributed around the circumference of the wall 314 of the catheter 310 to facilitate determining the directionality of the force. The inductive pressure sensor 320 typically includes a coil element 324 and a guide rod element 326 disposed within the distal end 513 of the catheter 510 to detect pressure exerted on the distal end 313 of the catheter 310. 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, results in relative movement of the distal pressure sensing segment 316 with respect to the proximal pressure sensing segment 318 (in this embodiment, against the biasing force of the biasing element 310), causing movement of the guide rod element 326 with respect to the coil element 324 to generate a signal. For example, the guide rod element 326 may extend distally from the coil element 324 and may move in response to or along with the movement of the distal pressure sensing segment 316 (e.g., upon contact with a proximal face 316p of the distal pressure sensing segment 316), thereby moving relative to the coil element 324 and generating a signal indicative of a force on the distal end 313 of the catheter 310.

[0044] Yet another type of sensor 120 that may be used in a catheter 110 according to the principles of the present disclosure is a piezoelectric sensor 420 as illustrated in the embodiment of Figures 8A and 8B. As is known in the art, piezoelectric materials deform when a force is applied to them and generate an electrical signal indicative of such force. An impact on the distal end 413 of the catheter 410 transmits the force to the piezoelectric sensor 420. In some embodiments, the impact may be a direct impact on the piezoelectric sensor 420, causing the piezoelectric sensor 420 to deform and generate a signal. In other embodiments, the impact occurs as a result of relative movement of the optionally separately movable distal pressure sensing segment 416 with respect to the proximal pressure sensing segment 418 (e.g., via a biasing element 430 between the distal and proximal pressure sensing segments 418, as described above with reference to other embodiments disclosed herein), generating a signal indicative of the distal end 413 of the catheter 410 impacting another object. Similar to the above-described embodiments of Figures 4A, 4B, 5A, 5B, 6A, 6B, 7A, and 7B, two or more piezoelectric sensors 420 may be provided around the wall 414 of the catheter 410 to facilitate determining the directionality of the force and using such information to facilitate navigation of the catheter 410. As can be appreciated, the piezoelectric sensors 420 may be actuated by contact from a number of different directions. In this manner, the piezoelectric sensors 420 may provide directional pressure sensing capabilities to the catheter 410 of Figures 8A and 8B based not only on the location of a given actuated piezoelectric sensor 420 relative to a position along the circumference of the catheter 410, but also based on the direction of the force applied to a given actuated piezoelectric sensor 420.

[0045] Instead of an axially extending sensor 120 to detect pressure on the distal end 113 of the catheter 110, multiple sensors 120 may extend radially across the distal end 513 of the catheter 510, as shown in the embodiment illustrated in Figures 9A and 9B. The radially extending sensor 520 may be disposed at the distal end 513 of the catheter 510 in the distal pressure sensing segment 516 of the catheter 510, as illustrated, without force being transmitted to the sensor 520 via an intermediate element (e.g., biasing element 130). 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., moving the catheter 510 to hit an obstacle such as a tissue wall or lumen wall), the sensor 520 deforms or is otherwise activated to generate a signal indicative of the impact thereon. The radial orientation of the sensor 520 may provide greater sensitivity to directional information or location of an impingement on 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 interior space 514s of the wall 514 of the catheter 510 and has sufficient sensitivity to forces (e.g., impact or bending forces) on the interior space 514s may be used.

[0046] Those skilled in the art should understand that the present discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the present disclosure. Although the foregoing disclosure describes a flexible (e.g., pressure-sensing) tip of a catheter, it should be understood that the principles described herein may be applied to other devices having a lumen therethrough. The embodiments of the present disclosure may be configured for use with medical devices and systems (e.g., endoscopic accessory instruments and / or guidewires inserted through a duodenoscope, etc.) 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 the embodiments of the present disclosure may also be used in a variety of other medical procedures that require navigating one or more accessory instruments through a duct, lumen, or vasculature, including, for example, interventional radiology procedures, balloon angioplasty procedures, thrombolysis procedures, angiography procedures, pulmonary procedures, etc. The medical devices of the present disclosure are not limited to a particular type of endoscope, such as a duodenoscope, but may include a variety of medical devices for accessing body passageways, such as, for example, catheters, duodenoscopes, ureteroscopes, bronchoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, etc. Furthermore, the disclosed medical devices and systems may be inserted via a number of different access points and approaches, for example, percutaneous, endoscopic, laparoscopic, or via some combination thereof.

[0047] The foregoing discussion has broad applicability and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, ratios, and with other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations to facilitate the present disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the present disclosure may be combined into alternative aspects, embodiments, or configurations. Although the present disclosure is presented with respect to embodiments, it should be understood that the various separate features of the present subject matter need not all be present to achieve at least some of the desired properties and / or benefits of the present subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many modifications specifically adapted to a particular environment and operational requirements, or modifications of the structure, arrangement, proportions, materials, components, and other aspects used in the practice of the present disclosure, without departing from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise changed, and sizes or dimensions of elements may be changed. Similarly, although operations, actions, or steps are described in a particular order, this should not be understood as requiring such a particular order or that all operations, actions, or steps should be performed to achieve desired results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, 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 light of the foregoing, it is to be understood that the individual features of any embodiment may be used separately or in combination with the features of that embodiment 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] From the foregoing description and the claims that follow, it will be understood that: As used herein, the terms "at least one," "one or more," and "and / or" are open-ended expressions that act both conjunctively and disjunctively. Terms such as "a," "an," "the," "first," "second," etc. do not exclude a plurality. For example, the term "a" or "an" entity as used herein refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (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 aid the reader in understanding this disclosure and / or serve to distinguish regions of related elements from one another, and do not limit the related elements, particularly with respect to the location, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between groups of elements and relative movement between elements, unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another. The following claims are incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of this disclosure. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.

[0049] The following claims are incorporated by reference into this Detailed Description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. In addition, although individual features may be included in different claims, which may in some cases be advantageously combined, the inclusion in different claims does not imply that the combination of features is not feasible and / or advantageous. In addition, singular references do not exclude a plurality. Terms such as "a", "an", "the", "first", "second" etc. do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. A flexible elongate member, the flexible elongate member has a tubular wall, the tubular wall including 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 an interior space therebetween and defining a working channel within the inner tubular wall, the working channel being sized and configured to permit passage of multiple instruments therethrough to perform a procedure at a treatment site, the interior 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 comprising at least one navigational aid pressure sensor disposed within the interior space at the flexible distal end of the flexible elongate member to detect deflection of the flexible distal end and to generate a signal indicative of the flexible distal end of the flexible elongate member encountering an object. Flexible elongated member.

2. The flexible elongate member of claim 1 , wherein the at least one navigational aid pressure sensor is a pressure sensor capable of detecting collision of the flexible distal end of the flexible elongate member against an object.

3. The flexible elongate member of claim 2 , wherein the at least one navigational aid pressure sensor comprises at least four sensors equally spaced around a periphery of the interior space.

4. The flexible elongate member of claim 1 , wherein the at least one navigational aid pressure sensor comprises one of a fiber optic, an inductive sensor, or a piezoelectric sensor.

5. a flexible elongate member defining a working channel sized and configured to permit passage of a plurality of instruments therethrough for performing a procedure at 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 within the outer tubular wall, the outer tubular wall and the inner tubular wall defining an interior space therebetween, the interior 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 includes at least one pressure sensor disposed within the interior space 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 configured to detect deflection of the flexible distal end; Flexible elongated member.

6. The flexible elongate member of claim 5 , wherein the at least one pressure sensor is a pressure sensor that detects impact of the flexible distal end of the flexible elongate member against an object.

7. The flexible elongate member according to claim 5 or 6, wherein the at least one pressure sensor comprises one of an optical fiber, an inductive sensor, or a piezoelectric sensor.

8. A flexible elongate member according to any one of claims 5 to 7, wherein the flexible distal end of the flexible elongate member comprises a proximal pressure sensing segment and a distal pressure sensing segment which are axially movable relative to one another.

9. The flexible elongate member of claim 8 , further comprising a biasing element that biases the proximal and distal pressure sensing segments apart when the flexible distal end of the flexible elongate member is in a neutral configuration in which it is not colliding with an object.

10. 10. The flexible elongated member of claim 8 or 9, wherein the at least one pressure sensor is provided on the proximal pressure sensing segment, and relative movement of the distal pressure sensing segment with respect to the proximal pressure sensing segment activates the at least one pressure sensor to generate a signal.

11. The flexible elongate member of any one of claims 1, 5 to 10, further comprising a camera within the interior space.

12. A flexible elongate member according to any one of claims 5 to 11, wherein the at least one pressure sensor consists of at least three sensors providing directional information.

13. A flexible elongate member according to any one of claims 5 to 12, wherein the at least one pressure sensor consists of at least four sensors equally spaced around the periphery of the interior space.

14. 1. A system comprising: The system includes a handle; The system comprises a flexible elongate member extending 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 passage of multiple instruments therethrough to perform a procedure at a treatment site, and defining an interior space between the outer tubular wall and the inner tubular wall; the system comprising at least one navigational aid pressure sensor disposed within the interior 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; 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 navigational aid pressure sensor is disposed within the flexible distal end of the flexible elongate member; system.

15. The system of claim 14 , further comprising a control unit that processes signals from the at least one navigation aid pressure sensor to indicate directional information regarding an impact of the flexible distal end of the flexible elongate member against an object.

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