Systems and methods for modular endoscope

Abstract

To provide an articulating flexible endoscope.SOLUTION: The endoscope comprises: a distal tip portion that is steerable via a driving mechanism; a bending section connected to the distal tip portion at a first end, and connected to a shaft portion at a transition interface, the bending section being articulated by one or more pull wires; and the shaft portion comprising one or more load transmission tubes for reducing at least a portion of the articulation force applied to the bending section by the one or more pull wires thereby improving stability of the shaft portion. The one or more load transmission tubes are firmly anchored to the transition interface and have a length greater than the length of the shaft portion.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Reference

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 950,740, filed Dec. 19, 2019, and U.S. Provisional Patent Application No. 63 / 091,268, filed Oct. 13, 2020, each of which is hereby incorporated by reference in its entirety.

Background Art

[0002] Background of the Invention

[0002] In endoscopic procedures, the interior of a hollow organ or body cavity is examined using an endoscope. Unlike many other medical imaging techniques, an endoscope is inserted directly into an organ. Flexible endoscopes, which can provide intuitive manipulation and control, are useful for the diagnosis and treatment of diseases accessible from any natural orifice of the body. Depending on the clinical application, an endoscope can be designated as a bronchoscope, ureteroscope, colonoscope, gastroscope, otolaryngology endoscope, and various others. For example, flexible endoscopy is used to examine and treat diseases of the gastrointestinal (GI) tract without the need to form an opening in the patient's body. The endoscope is introduced into the upper or lower GI tract through the mouth or anus, respectively. A small camera at the distal end takes images of the digestive wall that assist the clinician in diagnosing GI tract diseases. Simple surgical procedures (such as polyp resection and biopsy) can be performed by introducing a flexible tool through the working channel and reaching the distal end to the site of interest.

[0003]

[0003] Conventionally, endoscopes are manufactured to be reusable and may require thorough cleaning, disinfection, and / or sterilization after each procedure. In most cases, cleaning, disinfection, and sterilization can be an aggressive process to kill bacteria and / or germs. Such procedures can also be harsh on the endoscope itself. Therefore, the design of such reusable endoscopes often becomes complex, especially to ensure that the endoscope can withstand such harsh cleaning, disinfection, and sterilization protocols. Regular maintenance and repair of such reusable endoscopes are often required.

[0004]

[0004] Low-cost disposable medical devices designated for single use are becoming popular as an alternative to instruments that are difficult to clean properly. Single-use disposable devices can be packaged in a sterile enclosure to avoid the risk of cross-contamination of pathogens of diseases such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use disposable products because they no longer need to worry about the product's years of use, excessive use, damage, failure, or sterilization. Conventional endoscopes often include a handle used by an operator to manipulate the endoscope. In the case of a single-use endoscope, the handle typically encloses a camera, expensive electronics, and a mechanical structure at the proximal end to transmit images and enable the user to operate the endoscope via a user interface. This can make the handle for a single-use endoscope costly.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Summary of the Invention

[0005] There is a recognized need for an endoscope that enables surgical procedures or diagnostic operations with improved outcomes and cost - effectiveness. Also recognized herein are devices and systems that include an endoscope that can be disposable and that do not require extensive cleaning procedures. The present disclosure provides a low - cost, single - use, articulable endoscope for diagnosis and treatment in a variety of applications such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, otolaryngology, gastrointestinal endoscopy, neurosurgery, and various others. The endoscope system provided is useful in a variety of minimally invasive surgical, therapeutic, or diagnostic procedures including, but not limited to, various types of tissues including heart, bladder, and lung tissue, in other anatomical regions of a patient's body such as the digestive system including the esophagus, liver, stomach, colon, urinary tract, or the respiratory system including, but not limited to, the bronchi, lungs, and various others.

[0006]

[0006] The various components of the modular endoscope components and devices provided are useful in a variety of minimally invasive surgical, therapeutic, or diagnostic procedures including, but not limited to, various types of tissues including heart, bladder, and lung tissue, in other anatomical regions of a patient's body such as the digestive system including the esophagus, liver, stomach, colon, urinary tract, or the respiratory system including, but not limited to, the bronchi, lungs, and various others.

Means for Solving the Problem

[0007]

[0007] In one aspect, an articulating flexible endoscope is provided. The articulating flexible endoscope includes a distal tip portion that is operable via a drive mechanism, a bending section connected to the distal tip portion at a first end and to a shaft portion at a transition interface, the bending section being articulable by one or more pull wires, and a shaft portion that includes one or more load - transfer tubes for housing the one or more pull wires and thereby improving the stability of the shaft portion.

[0008]

[0008] In some embodiments, the distal tip portion includes a structure for receiving an imaging device, a position sensor, and an illumination device. In some embodiments, each of the one or more pull wires is disposed inside the lumen of each of the one or more load transfer tubes. In some embodiments, the bending section is bent in two or more directions by the one or more pull wires. In some embodiments, the one or more load transfer tubes are firmly fixed to the transition interface and have a length greater than the length of the shaft portion. In some embodiments, the one or more load transfer tubes have a non-linear configuration. In some embodiments, the one or more load transfer tubes have a helical configuration.

[0009]

[0009] In some embodiments, the shaft portion includes a tube having an integrally formed structure for changing the rigidity of the shaft portion. In some embodiments, the articulating flexible endoscope further includes a deformable working channel. In some embodiments, the articulating flexible endoscope further includes a handle portion, and the handle portion is configured to process image data, provide power to one or more electronic components located at the distal tip portion, or establish communication with an external device. Optionally, the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. In some examples, the interface is an electrical interface and a mechanical interface. Optionally, the handle portion includes a mechanical control module for interfacing with a perfusion system or a suction system.

[0010] In another aspect, a disposable endoscope is provided. The disposable endoscope includes a distal tip portion including an imaging device, a position sensor, and an illumination device, a bending section connected to the distal tip portion at a first end and connected to a shaft portion at a second end, the bending section being articulatable by one or more pull wires, and a shaft portion including one or more load transfer tubes for accommodating the one or more pull wires and thereby improving the stability of the shaft portion.

[0011] In some embodiments, the distal tip portion includes a structure for receiving the imaging device, the position sensor, and the illumination device. In some embodiments, the imaging device, the position sensor, and the illumination device are arranged in a compact configuration. In some embodiments, the one or more load transfer tubes have a length greater than the length of the shaft portion.

[0012] In some embodiments, each of the one or more pull wires is disposed inside the lumen of a respective one of the one or more load transfer tubes. In some embodiments, the one or more pull wires are movable relative to the one or more load transfer tubes. In some embodiments, the bending section is bent in two or more directions by the one or more pull wires. In some embodiments, the one or more load transfer tubes have a non-linear configuration. In some embodiments, the one or more load transfer tubes have a helical configuration.

[0013]

[0013] In some embodiments, the shaft portion includes a tube having an integral structure for varying the rigidity of the shaft portion. In some embodiments, the disposable endoscope further includes a deformable working channel. In some embodiments, the disposable endoscope further includes a handle portion, and the handle portion is configured to process image data, to provide power to the imaging device, the position sensor, and the illumination device, or to establish communication with an external device. Optionally, the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. In some examples, the interface includes an electrical interface and a mechanical interface. In some examples, the mechanical interface is configured to removably couple the handle portion to the instrument drive mechanism.

[0014]

[0014] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, which illustrates only exemplary embodiments of the present disclosure. As will be understood, the present disclosure is capable of other different embodiments and some of the details thereof are capable of modifications in various obvious respects without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

[0015] Incorporation by reference

[0015] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent that the incorporated publications and patents or patent applications conflict with the disclosure contained herein, this specification is intended to supersede and / or take precedence over such conflicting matter.

[0016] Brief description of the drawings

[0016] The novel features of the present invention are described in detail in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description which illustrates exemplary embodiments in which the principles of the invention are utilized, and to the accompanying drawings (also referred to herein as "Figure" and "FIG.").

Brief Description of the Drawings

[0017]

Figure 1

[0017] Examples of flexible endoscopes according to some embodiments of the present disclosure are illustrated.

Figure 2

[0018] Examples of endoscopes provided with an articulation power transmission mechanism according to some embodiments of the present invention are shown.

Figure 3A

[0019] Examples of one or more pull wires assembled to one or more load transmission tubes in a bending section are shown.

Figure 3B

[0019] Examples of one or more pull wires assembled to one or more load transmission tubes in a bending section are shown.

Figure 4

[0020] Examples of load transmission tubes terminated at a distal shaft region and a proximal shaft region are shown.

Figure 5

[0021] Examples of load transmission tubes terminated at a distal shaft region and a proximal shaft region are shown.

Figure 6

[0022] Examples of the structure of an existing steerable catheter are shown.

Figure 7

[0023] Examples of the design of an insertion shaft are shown.

Figure 8

[0024] Examples of robotic bronchoscopes according to some embodiments of the present invention are shown.

Figure 9

[0025] Examples of an instrument drive mechanism that provides a mechanical interface to a handle portion of a robotic bronchoscope according to some embodiments of the present invention are shown.

Figure 10

[0026] An exemplary handle portion of a robotic bronchoscope according to some embodiments of the present invention is shown.

Figure 11

[0027] An exemplary steerable catheter according to some embodiments of the present invention is shown.

Figure 12

[0028] An exemplary distal portion of a catheter with an integrated imaging device and illumination device is shown.

Figure 13

[0029] An example of a compact configuration of a plurality of electronic elements disposed at a distal portion of a catheter according to some embodiments of the present invention is shown.

Figure 14

[0030] Examples of a conventional configuration and a novel configuration of a pull wire attached to a control ring structure are shown.

Figure 15

[0031] Various configurations of a pull wire for a robotic catheter system according to some embodiments of the present invention are shown.

Figure 16

[0032] An example of a guide wire with an inflatable tip according to some embodiments of the present invention is shown.

Figure 17

[0033] An example of an endoscope tip design is shown.

Best Mode for Carrying Out the Invention

[0018] Detailed Description of the Invention

[0034] Although various embodiments of the present invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions can be contemplated by those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be used.

[0019]

[0035] The embodiments disclosed herein can be combined in one or more ways among many ways to provide improved diagnosis and treatment to patients. The disclosed embodiments can be combined with existing methods and devices to provide improved treatment, such as, for example, in combination with known methods of lung diagnosis, surgery, and surgery of other tissues and organs. Any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of any one or more of the methods and devices described herein, and it should be understood that the drawings and the supplementary text provide an explanation according to the embodiments.

[0020]

[0036] Exemplary embodiments are mainly directed to devices or systems for bronchoscopy, but those skilled in the art will understand that this is not intended to be limiting. Also, the devices described herein can be used in various anatomical regions of a patient's body for other therapeutic or diagnostic procedures. The devices or systems provided can be used in urology, gynecology, rhinology, otology, laryngoscopy, and gastroenterology using endoscopes, composite devices including endoscopes and instruments, and endoscopes with positioning functions. Those skilled in the art will understand that this is not intended to be limiting. Also, the devices described herein can be in the form of neuroendoscopes, brain endoscopes, ophthalmoscopes, otoscopes, nasal endoscopes, pharyngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuroscopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, choledochoscopes, cholangioscopes, laparoscopes, amnioscopes, ureteroscopes, hysteroscopes, cystoscopes, proctoscopes, colonoscopes, arthroscopes, salivary duct endoscopes, orthopedic endoscopes, and others, in combination with various tools or instruments, for other therapeutic or diagnostic procedures in other anatomical regions of a patient's body, such as the brain, heart, lungs, intestines, eyes, skin, kidneys, liver, pancreas, stomach, uterus, ovaries, testes, bladder, ears, nose, mouth, bone marrow, adipose tissue, muscle, gland and mucosal tissue, soft tissues such as spinal cord and nerve tissue, cartilage, hard biological tissues such as teeth and bones, and body cavities and passages such as sinuses, ureters, colon, esophagus, lung passages, blood vessels and pharynx, and various others.

[0021]

[0037] The systems and devices described herein can be combined in one or more ways out of many ways to provide improved diagnosis and treatment to patients. The embodiments provided herein can be combined with existing methods and devices, for example, in combination with known methods of lung diagnosis, surgery, and surgery of other tissues and organs, to provide improved treatment. Any one or more of the structures and steps described herein can be combined with any one or more additional structures and steps of the methods and devices described herein, and it should be understood that the drawings and the supplementary text provide an explanation according to the embodiments.

[0022]

[0038] When the terms "at least", "greater than", or "above" are in front of the first numerical value of a series of two or more numerical values, the terms "at least", "greater than", or "above" always apply to each numerical value of that series of numerical values. For example, 1, 2, or 3 or more is equivalent to 1 or more, 2 or more, or 3 or more.

[0023]

[0039] When the terms "not exceeding", "less than", or "below" are in front of the first numerical value of a series of two or more numerical values, the terms "not exceeding", "less than", or "below" always apply to each numerical value of that series of numerical values. For example, 3, 2, or 1 or below is equivalent to 3 or below, 2 or below, or 1 or below.

[0024]

[0040] As used herein, the terms distal and proximal may generally refer to positions relative to a device and may be opposite to anatomical references. For example, the distal position of a main shaft or catheter may correspond to the proximal position of a patient's elongate member, and the proximal position of a main sheath or catheter may correspond to the distal position of a patient's elongate member.

[0025] Modular flexible endoscope

[0041] In one aspect of the present invention, a flexible endoscope is provided with improved results at low cost. FIG. 1 illustrates an example of a flexible endoscope 100 according to some embodiments of the present disclosure. As shown in FIG. 1, the flexible endoscope 100 may include a handle portion 109 and a flexible elongate member that is inserted into the interior of a subject. In some embodiments, the flexible elongate member may include a shaft (e.g., insertion shaft 101), an operable tip (e.g., tip 105), and an operable section (flexure section 103). The endoscope 100 may also be referred to as an operable catheter assembly, as described elsewhere herein. Optionally, the endoscope 100 may be a single-use robotic endoscope. Optionally, the entire catheter assembly may be disposable. Optionally, at least a portion of the catheter assembly may be disposable. Optionally, the entire endoscope may be removed from the instrument drive mechanism and discarded. In some embodiments, the endoscope may have varying levels of stiffness along the shaft to improve its functional operation.

[0026]

[0042] The endoscope or operable catheter assembly 100 may include a handle portion 109 that may include one or more components configured to process image data, provide power, or establish communication with other external devices. For example, the handle portion may include circuitry and communication elements that enable electrical communication between the operable catheter assembly 100 and an instrument drive mechanism (not shown) and any other external system or device. In another example, the handle portion 109 may include circuit elements such as a power source for providing power to the electronics of the endoscope (e.g., a camera, an electromagnetic sensor, and an LED light).

[0027]

[0043] One or more components located on the handle can be optimized such that expensive and complex components are assigned to the robotic support system, the handheld controller, or the instrument drive mechanism, thereby reducing costs and simplifying the design of the disposable endoscope. Optionally, the handle portion can receive image / video data and / or sensor data via an electrical interface (e.g., a printed circuit board) from the communication module of the instrument drive mechanism and can transmit the image / video data and / or sensor data to other external devices / systems. Optionally, the electrical interface can establish electrical communication without cables or wires. For example, the interface can include pins soldered to an electronic substrate such as a printed circuit board (PCB). For example, a receptacle connector (e.g., a female connector) is provided on the instrument drive mechanism as a mating interface. This can advantageously enable the endoscope to be quickly inserted into the instrument drive mechanism or the robotic support without using extra cables. Such a type of electrical interface can also serve as a mechanical interface such that both mechanical and electrical couplings are established when the handle portion is inserted into the instrument drive mechanism. Alternatively or in addition, the instrument drive mechanism can provide only a mechanical interface. The handle portion can communicate electrically with a modular wireless communication device or any other user device (e.g., a portable / handheld device or a controller) for transmitting sensor data and / or receiving control signals.

[0028]

[0044] Optionally, the handle portion 109 can include one or more mechanical control modules such as a luer 111 for interfacing with the irrigation system / suction system. Optionally, the handle portion can include a lever / knob for articulation control. Alternatively, the articulation control can be located on a separate controller attached to the handle portion via the instrument drive mechanism.

[0029]

[0045] The endoscope can be attached to a robotic support system or a handheld controller via an instrument drive mechanism. The instrument drive mechanism can be provided by any suitable controller device (e.g., a handheld controller) that may or may not include a robotic system. The instrument drive mechanism can provide a mechanical and electrical interface to the steerable catheter assembly 100. The mechanical interface can enable the steerable catheter assembly 100 to be removably coupled to the instrument drive mechanism. For example, the handle portion of the steerable catheter assembly can be attached to the instrument drive mechanism via quick-attachment / detachment means such as magnets, spring-loaded levers, etc. Optionally, the steerable catheter assembly can be manually coupled to or removed from the instrument drive mechanism without using tools. Details of the instrument drive mechanism will be described later in this specification.

[0030]

[0046] In the illustrated example, the distal tip of the catheter or endoscope shaft is configured to articulate / flex in two or more degrees of freedom to provide a desired camera view or to control the direction of the endoscope. As illustrated in the example, an imaging device (e.g., a camera), a position sensor (e.g., an electromagnetic sensor) 107 is located at the tip 105 of the catheter or endoscope shaft. For example, the line of sight of the camera can be controlled by controlling the articulation of the flexion section 103. In some examples, the angle of the camera can be adjustable such that the line of sight can be adjusted without articulating or in addition to articulating the distal tip of the catheter or endoscope shaft. For example, the camera can be oriented at an angle (e.g., tilted) with respect to the axial direction of the tip of the endoscope using optimal components.

[0031]

[0047] The distal tip 105 can be a rigid component that enables the positioning of sensors such as electromagnetic (EM) sensors, imaging devices (e.g., cameras), and other electronic components (e.g., LED light sources) to be embedded in the distal tip.

[0032]

[0048] In real-time electromagnetic tracking, an EM sensor composed of one or more sensor coils embedded in a medical device (e.g., the tip of an endoscopic tool) at one or more positions and orientations measures the fluctuations of an electromagnetic field created by one or more electrostatic field generators positioned in the vicinity of the patient. The position information detected by the EM sensor is stored as EM data. The electromagnetic field generator (or transmitter) can be positioned in the vicinity of the patient to create a low-intensity magnetic field that can be detected by the embedded sensor. The magnetic field induces a weak current in the sensor coil of the EM sensor, and this current can be analyzed to determine the distance and angle between the EM sensor and the electromagnetic field generator. For example, the electromagnetic field generator can be positioned in the vicinity of the patient's torso during a procedure to locate the position of the EM sensor in 3D space, or the position and orientation of the EM sensor can be located in 5D or 6D space. This can provide visual guidance to the operator when driving the bronchoscope towards the target site. Details of the chip design and the multiple components embedded in the chip will be described later in this specification.

[0033]

[0049] The endoscope can have a unique design for the shaft component. Optionally, the insertion shaft of the endoscope can consist of a single tube incorporating a series of cuts (e.g., undulations, slits) over the length of the insertion shaft to provide improved flexibility and desirable rigidity. Details of the shaft design will be described later in this specification.

[0034]

[0050] The flexion section 103 can be designed to allow flexion with two or more degrees of freedom (e.g., articulation). Larger flexion degrees such as 180 degrees and 270 degrees (or other articulation parameters for clinical applications) can be achieved by the unique structure of the flexion section. Optionally, the flexion section can be manufactured separately as a modular component and assembled to the insertion shaft. Optionally, the flexion section can further incorporate a minimum necessary function, thereby reducing costs and improving reliability. For example, the flexion section can incorporate a cut pattern that beneficially provides a greater tube deflection to achieve a desired tip displacement relative to the insertion shaft.

[0035]

[0051] In some embodiments, the flexion section or endoscope can include an articulation force transmission mechanism to ensure that the endoscope is stable and provides an intuitive responsiveness of the flexion section. FIG. 2 shows an example of an endoscope equipped with an articulation force transmission mechanism 201 according to some embodiments of the present invention. The articulation force transmission mechanism 201 can include a plurality of load transmission tubes located within the bore of the insertion shaft / tube. Optionally, at least one, two, three, four, five, or more load transmission tubes can be included to reduce the axial compression / elongation (strain) of the insertion tube 203 during articulation of the flexion section. The load transmission tubes can transmit at least a portion of the articulation load applied to the flexion section and / or shaft back to the handle (e.g., via an actuator or motor that drives one or more articulated pull wires).

[0036]

[0052] The shaft portion may include one or more load transfer tubes for accommodating one or more pull wires. The load transfer tubes cancel out the load of the articulating movement, resulting in an improvement in the stability of the insertion shaft. A plurality of load transfer tubes 201 may be present within the lumen of the shaft tube (i.e., the bore of the tube) and may be configured to transmit the articulation reaction force from the bending section to the handle portion. The load transfer tubes are configured to transmit the articulation reaction force of the bending section back to the handle portion, thereby reducing the articulation force applied to the insertion shaft tube. Such a design may beneficially prevent these articulation forces from being dissipated through the insertion shaft tube, thereby providing a stable shaft. The transmission modality described herein may ensure that the insertion shaft tube is subjected to only minimal axial compression or elongation forces and thus remains stable during the articulation of the bending section.

[0037]

[0053] In a preferred embodiment of the load transfer mechanism, the plurality of load transfer tubes 201 may be longer than the length of the insertion shaft tube 203. The length of the plurality of load transfer tubes 201 may be determined such that when the load transfer tubes are in an axially compressed state, the length of the load transfer tubes is still longer than the length of the insertion shaft tube 203, thereby preventing the transmission of load through the insertion shaft tube. For example, the length of the load transfer tubes may be at least 0.01%, 0.1%, 0.2%, 0.3%, 1%, 5%, 10% longer than the length of the insertion shaft. The length of the load transfer tubes may be determined based at least in part on the dimensions of the inner diameter of the shaft. For example, the load transfer tubes may have a helical configuration that provides sufficient rigidity to support / transmit the load.

[0038]

[0054] The load transfer tube may have dimensions and a configuration that can accommodate displacement within the shaft tube. For example, by following a serpentine anatomical structure, when the insertion shaft tube 203 bends, the insertion shaft tube can cause displacement of components housed within the bore of the insertion shaft tube. In this case, the extra length of the load transfer tube can, beneficially, improve the stability of the shaft while also accommodating displacement within the bore of the insertion shaft tube. Compared to existing techniques that may utilize a coil pipe and service loop within the handle portion, the modular design and assembly of the load transfer tube can, beneficially, reduce costs without compromising the performance of the shaft. Compared to other existing techniques (shown in FIG. 6) where a pull wire is incorporated into the shaft, the provided load transfer mechanism can, beneficially, transfer load from the bent section to the handle without compressing the shaft, thereby improving the stability of the shaft.

[0039]

[0055] Multiple load transfer tubes can be firmly fixed to the proximal end 207 and the distal end 205 of the insertion shaft tube 203. As described above, since the load transfer tube is longer than the length of the insertion shaft tube, the load transfer tube can have a non-linear / non-straight configuration within the bore of the insertion shaft tube that provides flexibility to accommodate displacement caused by bending. For example, one or more load transfer tubes can have a non-linear (e.g., helical) configuration that allows movement within the main lumen of the endoscope taking into account the shape change of the shaft length when the endoscope follows a serpentine shape while being positioned within an anatomical structure. Such a load transfer mechanism can, beneficially, act as a natural spring that dampens the effect of movement from the outer insertion shaft.

[0040]

[0056] In some embodiments, one or more load transfer tubes may surround one or more pull wires. The articulation movement of the endoscope can be controlled by applying a force to the distal end of the endoscope via one or more pull wires. One or more pull wires can be attached to the distal end of the endoscope. In the case of multiple pull wires, by pulling one wire at a time, the orientation of the distal tip can be changed to tilt in the up, down, left, right, or any desired direction. Optionally, the pull wire can be firmly fixed to the distal tip of the endoscope, extend through the bending section, enter the handle, and within the handle, the pull wire is coupled to a drive component (e.g., a pulley). This handle pulley can interact with the output shaft from the robotic system.

[0041]

[0057] In some embodiments, one or more pull wires can be located within one or more load transfer tubes or extend through the interior of the transfer tube. FIGS. 3A and 3B show an example of one or more pull wires 305 assembled to a load transfer tube 307 in a bending section 301. As shown in FIG. 3A, the bending section 301 can be composed of a stainless-steel ribbon. The bending section can be formed of other suitable structures or materials to achieve a predetermined bending stiffness while maintaining the desired axial and torsional stiffness for small articulation forces. For example, the bending section can include a braided structure for torsional stability. In the illustrated example, multiple pull wires 305 can extend through or be disposed within the lumen of the load transfer tube 307 and the bending section, terminated at the tip of the endoscope.

[0042]

[0058] For example, a drive mechanism (e.g., an actuator, a motor) can be engaged with a pull wire to cause the bending section to articulate. One or more load transfer tubes can be configured to transfer at least a portion of the load of the articulation movement (e.g., compressive force) from the bending section back to the handle or the motor, for example, by respectively disposing one or more pull wires inside one or more load transfer tubes. Relative movement can occur between the pull wire and the corresponding load transfer tube during the articulation movement. One or more load transfer tubes can transfer at least a portion of the load of the articulation movement applied to the bending section and / or the shaft back to the handle (e.g., a motor that drives one or more articulated pull wires). Thereby, beneficially, at least a portion of the articulation force applied to the bending section and / or the insertion shaft is reduced, whereby the stability of the insertion shaft can be improved.

[0043]

[0059] The endoscope can include a bending section transition portion 303 located at the joint boundary between the bending section and the shaft. The bending section transition portion 303 can include a structure that can enable efficient and convenient assembly of the endoscope. For example, the bending section transition portion 303 can include mechanical components such as snaps / clips for firmly fixing a load transfer tube (e.g., a hypo tube) to the notch-shaped portion of the insertion shaft. FIG. 3B shows another example of the bending section transition portion 309. In the illustrated example, the load transfer tube can be firmly fixed to the interface between the insertion shaft and the bending section by welding to the transition ring structure of the bending section transition portion 309. Thereby, beneficially, the abrupt change in rigidity between the shaft portion and the bending section is reduced, whereby kinking can be prevented.

[0044]

[0060] Figure 4 shows an example of a load transfer tube 401 terminated at a distal shaft region 403 and a proximal shaft region 405. As described above, the load transfer tube has a non-linear / non-straight configuration within the bore of the insertion tube, thereby providing flexibility to accommodate displacements caused by bending. The load transfer mechanism may include one or more load transfer tubes, as shown in the example. Such a load transfer mechanism can advantageously serve as a natural spring that attenuates the effects of movement from the outer insertion shaft without requiring additional service loops in the handle portion. In the illustrated example, the end portions of the load transfer tube may be connected (e.g., welded) and fixed to a bend section transition 407. The bend section transition 407 may include a coupling structure 409 (e.g., a snap structure) for easy assembly to the insertion shaft.

[0045]

[0061] Optionally, one or more load transfer tubes may be constructed of a material such as a metal tubing or a metal wound coil pipe. The geometry and / or material of the load transfer tube may be selected / determined to provide the desired axial and bending stiffness. For example, the material may be a metal material such as stainless steel or nitinol, a rigid polymer such as PEEK, glass or carbon-filled PEEK, Ultem, polysulfone, and other suitable materials. Optionally, one or more load transfer tubes may have an inner diameter larger than the outer diameter of the pull wire to allow for relative movement (e.g., translational and / or rotational movement) between the load transfer tube and the pull wire. The wall thickness of one or more load transfer tubes may be determined based on the load transfer function required to transmit the load of the articulating movement of the bend section.

[0046]

[0062] Figure 5 shows an example of a load transfer tube 501 terminated at a distal shaft region 503 and a proximal shaft region. As described elsewhere in this specification, the load transfer tube 501 may be located within the lumen of an insertion shaft (not shown) and outside of the working channel 505.

[0047]

[0063] FIG. 6 shows an example of the structure 600 of an existing steerable catheter. In existing catheter designs without a load transfer tube, one or more pull wires 609 typically extend through conduits 607 incorporated into the walls of the insertion shaft 605 and the bending section 603. The catheter shaft may have a central bore / lumen 611 that is coaxial with the neutral axis. As shown in the cross-sectional view, the wall of the shaft or the wall of the bending section may have an incorporated structure (e.g., lumen, conduit) for passing the pull wire. In such a case, the shaft may support the loads of articulation movements that can result in an unstable shaft.

[0048]

[0064] FIG. 7 shows an example design of the insertion shaft. As described above, the insertion shaft of the endoscope can be composed of a single tube with an integrally formed structure for varying the rigidity of the shaft portion. For example, the tube may have a series of cuts (or undulations, slits, etc.) formed along its length. The cuts in the tube can have various profiles / patterns 701, 703 and densities along the length to create a bending rigidity that varies from the distal region to the proximal region. Thereby, advantageously, it may be possible to control the bending rigidity parameter by controlling the cuts in the insertion shaft.

[0049] Low-cost disposable robotic bronchoscope

[0065] In another aspect of the present invention, a disposable robotic bronchoscope is provided. The robotic bronchoscope can be the same as the steerable catheter assembly as described elsewhere in this specification. Conventional endoscopes can be complex in design and are typically designed to be reused after a procedure, and those procedures require thorough cleaning, disinfection or sterilization after each procedure. Existing endoscopes are often designed with a complex structure so that the endoscope can withstand the cleaning, disinfection and sterilization processes. The provided robotic bronchoscope can be a disposable endoscope that can beneficially suppress cross-contamination and infection between patients. Optionally, the robotic bronchoscope is intended to be delivered to the physician in a pre-sterilized package and discarded after a single use.

[0050]

[0066] FIGS. 8-10 show examples of robotic bronchoscopes according to some embodiments of the present invention. As shown in FIG. 8, the robotic bronchoscope 820 may include a handle portion 813 and a flexible elongate member 811. In some embodiments, the flexible elongate member 811 may include a shaft, an operable tip, and an operable section. The robotic bronchoscope 820 can be the same as the operable catheter assembly as described in FIG. 1. The robotic bronchoscope can be a single-use robotic endoscope. Optionally, only the catheter can be disposable. Optionally, at least a portion of the catheter can be disposable. Optionally, the entire robotic bronchoscope can be removed from the instrument drive mechanism and discarded. The bronchoscope can have various levels of stiffness along the shaft of the bronchoscope to improve its functional operation.

[0051]

[0067] The robotic bronchoscope can be detachably coupled to the instrument drive mechanism 820. The instrument drive mechanism 820 can be mounted on the arm of the robotic support system or on any actuation support system as described elsewhere in this specification. The instrument drive mechanism can provide a mechanical and electrical interface to the robotic bronchoscope 820. The mechanical interface can enable the robotic bronchoscope 820 to be detachably coupled to the instrument drive mechanism. For example, the handle portion of the robotic bronchoscope can be attached to the instrument drive mechanism via quick-attach / detach means such as magnets and spring levels. Optionally, the robotic bronchoscope can be manually coupled to or removed from the instrument drive mechanism without using tools.

[0052]

[0068] FIG. 9 shows an example of an instrument drive mechanism 920 that provides a mechanical interface to the handle portion 913 of a robotic bronchoscope. As shown in the example, the instrument drive mechanism 920 can include a set of motors that are actuated to rotationally drive a set of pull wires of a catheter. The handle portion 913 of the catheter assembly can be attached to the instrument drive mechanism such that the pulley assembly of the handle portion 913 is driven by the set of motors. The number of pulleys can vary depending on the configuration of the pull wires. Optionally, one, two, three, four, or more pull wires can be utilized to articulate the catheter.

[0053]

[0069] The handle portion can be designed to enable the robotic bronchoscope to be used in a low-cost disposable manner. For example, conventional manual and robotic bronchoscopes can have a cable at the proximal end of the handle of the bronchoscope. The cable often includes cables such as illumination fibers, camera video cables, other sensor fibers or electromagnetic (EM) sensors, or shape sensing fibers. Such complex cables can be costly in addition to the cost of the bronchoscope. The provided robotic bronchoscope can have an optimized design such that a simplified structure and components can be utilized while maintaining mechanical and electrical functions. Optionally, the handle portion of the robotic bronchoscope can adopt a cable-free design while providing a mechanical / electrical interface to the catheter.

[0054]

[0070] Figure 10 shows an exemplary handle portion 1000 of a robotic bronchoscope according to some embodiments of the present invention. Optionally, the handle portion 1000 can be a housing or can include components configured to process image data, provide power, or establish communication with other external devices. Optionally, the communication can be wireless communication. For example, the wireless communication can include Wi-Fi, radio wave communication, Bluetooth, IR communication, or other types of direct communication. Such wireless communication capabilities enable the robotic bronchoscope function in a plug-and-play manner and can be easily discarded after a single use. Optionally, the handle portion can include circuit elements such as a power source for supplying power to electronic devices (e.g., cameras and LED light sources) disposed within the robotic bronchoscope or catheter.

[0055]

[0071] The handle portion can be designed in conjunction with the catheter so as to eliminate cables or fibers. For example, the catheter portion can adopt a design having a single working channel that enables the instrument to pass through the robotic bronchoscope, as well as low-cost electronic devices such as a chip-on-tip camera, a lighting source such as a light-emitting diode (LED), and an EM sensor located at an optimal position according to the mechanical structure of the catheter. This can enable simplification of the design of the handle portion. For example, by using an LED for illumination, the termination in the handle portion can be based only on electrical soldering or wire crimping. For example, the handle portion can include a proximal substrate that connects to the interface of the handle portion to establish an electrical connection to the instrument drive mechanism, while the camera cable, LED cable, and EM sensor cable terminate at the proximal substrate. As described above, the instrument drive mechanism is attached to a robotic arm (robotic support system) and provides a mechanical and electrical interface to the handle portion. This can advantageously improve the efficiency of assembly and implementation and simplify the manufacturing process and cost. Optionally, the handle portion can be discarded together with the catheter after a single use.

[0056] Single-use steerable catheter

[0072] FIG. 11 shows an exemplary steerable catheter 1100 according to some embodiments of the present invention. In some embodiments, the catheter may have a substantially integral design in which one or more components may be integral with the catheter, thereby simplifying the assembly and manufacturing process while maintaining the kinematic dynamic performance of the steerable catheter. As shown in the example, the steerable catheter may include a elongate member 1101 or a probing portion for bringing it close to the tissue and / or region to be examined. The elongate member 1101 may sometimes be referred to as a catheter. The catheter 1101 may include an internal structure such as a working channel 1103 that allows tools as described elsewhere in this specification to be inserted therethrough. Optionally, the working channel may have a dimension such as a diameter of about 2 mm to have compatibility with standard tools.

[0057]

[0073] The catheter 1101 may be constructed of a material suitable for the desired flexibility or bending stiffness. Optionally, the material of the catheter may be selected such that it is not only substantially flexible (e.g., can be bent in various directions and orientations) but also maintains structural support for the internal structure (e.g., the working channel). For example, the catheter can be made of any suitable material such as Provista Copolymer, vinyl (such as polyvinyl chloride), nylon (such as Vestamid, Grillamid), polyurethane, polyethylene, polypropylene, polycarbonate, polyester, silicone elastomer, acetate. Optionally, the material may be a polymer material, a biocompatible polymer material, and the catheter may have sufficient flexibility to advance through a path with a small curvature without causing pain to the subject. Optionally, the catheter may include a sheath. The sheath does not have to be the same length as the catheter. The sheath may be shorter than the catheter to provide the desired support. Alternatively, the catheter may be a substantially single-piece component.

[0058]

[0074] Optionally, the distal portion or tip of the catheter may be substantially flexible so as to be steerable in one or more directions (e.g., pitch, yaw). The catheter may include the same tip portion, bending section, and insertion shaft as described in FIGS. 1-5. In some embodiments, the catheter may have a bending stiffness that varies along the longitudinal axis. For example, the catheter may include a plurality of segments having different bending stiffnesses (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials having different stiffness / rigidity, changing the structure in different segments (e.g., cuts, patterns), adding additional support components, or any combination of the above. Optionally, the proximal end of the catheter need not be bent significantly, and thus the proximal portion of the catheter may be reinforced using additional mechanical structures (e.g., additional material layers) to achieve a greater bending stiffness. Such a design may provide support and stability to the catheter. Optionally, the varying bending stiffness may be achieved by using different materials during the extrusion of the catheter. The use of different materials during extrusion may advantageously result in different degrees of stiffness along the shaft of the catheter in the extrusion manufacturing process without further fastening or assembly of the different materials.

[0059]

[0075] The distal portion of the catheter can be manipulated by one or more pull wires 1105. The distal portion of the catheter can be made of any suitable material such as a copolymer, polymer, metal, or alloy so that it can be bent by the pull wire. In some embodiments, the proximal end or proximal portion of one or more pull wires 1105 can be operably coupled to various mechanisms (e.g., gears, pulleys, etc.) within the handle portion of the catheter assembly. The pull wire 1105 can be a metal wire, cable or filament, or a polymer wire, cable or filament. The pull wire 1105 can also be made of natural or organic materials or natural or organic fibers. The pull wire 1105 can be any suitable type of wire, cable or filament capable of supporting various types of loads without deformation, significant deformation or breakage. The distal end or distal portion of one or more pull wires 1105 can be firmly fixed or integrated with the distal portion of the catheter, such that operation of the pull wire by the control unit can apply a force or tension to the distal portion (e.g., the flexible section) of the catheter to steer or articulate it (e.g., up, down, pitch, yaw, or any direction between those directions).

[0060]

[0076] As described above, the pull wire can be made of any suitable material such as stainless steel (e.g., SS316), metal, alloy, polymer, nylon or biocompatible material. The pull wire can be a wire, cable, or filament. In some embodiments, different pull wires can be made of different materials to vary the load-bearing capacity of the pull wire. In some embodiments, different sections of the pull wire can be made of different materials to vary the rigidity and / or load-bearing capacity along the pull. In some embodiments, the pull wire can be utilized for the transmission of electrical signals. The pull wire can extend through the lumen of one or more load-bearing tubes as described elsewhere in this specification.

[0061]

[0077] The catheter may have dimensions such that one or more electronic components can be integrated into the catheter. For example, the outer diameter of the distal tip may be about 4 to 4.4 millimeters (mm), and the diameter of the working channel may be about 2 mm such that one or more electronic components can be embedded within the wall of the catheter. However, it should be noted that based on different applications, the outer diameter can be in any range smaller than 4 mm or larger than 4.4 mm, and the diameter of the working channel can be in any range depending on the dimensions of the tool or a particular application.

[0062]

[0078] One or more electronic components may include an imaging device, an illumination device, or a sensor. In some embodiments, the imaging device may be a video camera 1113. The imaging device may include optical elements and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to the wavelength of light. Various image sensors may be used for capturing image data, such as a complementary metal-oxide-semiconductor (CMOS) or a charge-coupled device (CCD). The imaging device may be an inexpensive camera. Optionally, the image sensor may be provided on a circuit board. The circuit board may be an imaging printed circuit board (PCB). The PCB may include a plurality of electronic elements for processing the image signal. For example, a circuit for a CCD sensor may include an A / D converter and an amplifier for amplifying and converting the analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with an amplifier and a converter for converting the analog signal to a digital signal such that a circuit board is not required. Optionally, the output of the image sensor or the circuit board may be image data (a digital signal) and can be further processed by a camera circuit or a processor of the camera. Optionally, the image sensor may include an array of optical sensors.

[0063]

[0079] The illumination device may include one or more light sources 1111 positioned at the distal tip. The light source may be a light emitting diode (LED), an organic LED (OLED), a quantum dot, or any other suitable light source. Optionally, the light source may be a small LED for compact design or dual-tone flash LED illumination.

[0064]

[0080] The imaging device and the illumination device may be integrated into the catheter. For example, the distal portion of the catheter may include a suitable structure that at least matches the dimensions of the imaging device and the illumination device. The imaging device and the illumination device may be embedded in the catheter. FIG. 12 shows an exemplary distal portion of a catheter in which the imaging device and the illumination device are integrated. The camera may be located at the distal portion. The distal tip may have a structure for receiving the camera, the illumination device, and / or the position sensor. For example, the camera may be embedded in a cavity 1210 at the distal tip of the catheter. The cavity 1210 may be formed integrally with the distal portion of the cavity and may have dimensions that match the length / width of the camera so that the camera does not move relative to the catheter. The camera may be adjacent to the working channel 1220 of the catheter to provide a close-up view of the tissue or organ. Optionally, the posture or orientation of the imaging device may be controlled by controlling the rotational movement (e.g., roll) of the catheter.

[0065]

[0081] Power to the camera can be provided by a wired cable. Optionally, the cable wire can be located within a wire bundle that provides power not only to the illumination element or other circuitry at the distal tip of the catheter, but also to the camera. The camera and / or light source can be powered from a power source located in the handle portion via a wire, copper wire, or any other suitable means extending along the length of the catheter. Optionally, real-time images or videos of the tissue or organ can be wirelessly transmitted to an external user interface or display. The wireless communication can be WiFi, Bluetooth, RF communication, or other forms of communication. Optionally, the images or videos captured by the camera can be broadcast to multiple devices or systems. Optionally, the image and / or video data from the camera can be transmitted along the length of the catheter to a processor located within the handle portion via a wire, copper wire, or any other suitable means. The image or video data can be transmitted to an external device / system via a wireless communication component within the handle portion. Optionally, the system can be designed such that the wires are not visible or not exposed to the operator.

[0066]

[0082] In conventional endoscopy, the illumination light can be provided by a fiber cable that transmits the light of a light source located at the proximal end of the endoscope to the distal end of the robotic endoscope. In some embodiments of the present disclosure, in order to reduce the complexity of the design, small LED lights are used and can be embedded in the distal portion of the catheter. Optionally, the distal portion can include a structure 1230 having dimensions that match the dimensions of the small LED light source. As shown in the illustrated example, two cavities 1230 can be integrally formed with the catheter to receive two LED light sources. For example, the outer diameter of the distal tip can be about 4 to 4.4 millimeters (mm), and the diameter of the working channel of the catheter can be about 2 mm so that two LED light sources can be embedded in the distal end. The outer diameter can be in any range smaller than 4 mm or larger than 4.4 mm, and the diameter of the working channel can be in any range depending on the dimensions of the tool or the specific application. Any number of light sources can be included. The internal structure of the distal portion can be designed to accommodate any number of light sources.

[0067]

[0083] Optionally, each of the LEDs can be connected to a power wire that extends to the proximal handle. In some embodiments, the LEDs can be soldered to separate power wires that are later bundled to form a single twisted wire. In some embodiments, the LEDs can be soldered to a pull wire that supplies power. In other embodiments, the LEDs can be directly crimped or connected to a pair of power wires. Optionally, a protective layer, such as a thin layer of biocompatible adhesive, can be applied to the front of the LED to provide protection while allowing light emission. Optionally, an additional cover 1231 can be placed on the front end face of the distal tip to provide accurate positioning of the LED and sufficient space for the adhesive. The cover 1231 can be made of a transparent material that matches the refractive index of the adhesive so that the illumination light is not blocked.

[0068]

[0084] In some embodiments, one or more sensors may be embedded within the distal portion of the catheter. In conventional robotic bronchoscopes, sensors may be used to track the tip position, and these sensors are typically located at the distal tip, thereby causing enlargement of the tip. The provided steerable catheter may provide a compact design by bundling one or more electronic components. Optionally, an illumination source and one or more position sensors may be combined into a bundle. FIG. 13 shows an example of a compact configuration of electronic elements located in the distal portion. In some embodiments, a position sensor such as an electromagnetic (EM) sensor may be used to accurately track the position of the distal tip of the catheter. For example, an electromagnetic coil 1310 located at the distal end may be used with an electromagnetic tracking system to detect the position and orientation of the distal tip of the catheter while the catheter is placed within an anatomical system (e.g., an anatomical lumen network). Optionally, the coils may be angled to provide sensitivity to electromagnetic fields along different axes, providing the disclosed inductive guidance system with the ability to measure six degrees of freedom (three position degrees of freedom and three angular degrees of freedom).

[0069]

[0085] Optionally, one or more EM sensors 1310 may be located in the distal portion and may be arranged in a three-dimensional configuration adjacent to or behind an illumination source 1320 (e.g., an LED). Optionally, the EM sensors and the LED light source may form a bundle 1300. The power cable of the EM sensor may be bundled with the wires of the LED, resulting in reduced space and complexity. Optionally, differential 5D measurements or fused 6D measurements may be performed by three-dimensional alignment to enable accurate positioning and orientation sensing of the catheter distal tip. During the procedure, an electromagnetic field generator positioned adjacent to, below, or above the patient's torso may identify the position of the EM sensor, thereby enabling real-time tracking of the catheter tip position.

[0070] Pull-wire configuration and design

[0086] The robotic bronchoscope may include one or more pull wires for controlling the articulation movement of the catheter. In a conventional endoscope, the distal end or distal portion of one or more pull wires may be firmly fixed or attached to a control ring, such that by operating the pull wires by a control unit, a specific section or portion of the catheter (e.g., the distal section) can be steered or articulated (e.g., upward, downward, pitch, yaw, or in any direction between those directions), and a force or tension can be applied to the control ring. FIG. 14 shows an example of a conventional configuration of a pull wire 1413 attached to a control ring structure 1411 and a novel configuration 1420 of the present disclosure. The control ring may be attached to the distal end of the catheter 1415. Usually, the tip of the pull wire is welded or soldered to the control ring 1411, and the control ring may also be attached to the distal tip by welding. The welding process can be costly, cumbersome, and complex. Moreover, if one pull wire breaks or does not function properly, the entire steering control function may be affected.

[0071]

[0087] The provided robotic bronchoscope may include individually controlled pull wires, each of which is directly connected to a distal portion. As shown in Example 1420, one or more pull wires 1423 may be attached to an integrally formed structure 1421 of the distal portion. For example, the integrally formed structure 1421 may be a groove formed together with the distal tip. The groove may have a dimension or size that matches the dimension of the distal end 1421 of the pull wire so that the distal end of the pull wire can be easily crimped at the distal end. Thereby, advantageously, the assembly efficiency can be improved. In some examples, the pull wire may be firmly fixed to the groove at the distal end such that the distal end of the pull wire cannot move relative to the distal portion of the catheter.

[0072]

[0088] The pull-wire configuration can also result in improved reliability when operating the distal portion. For example, since each pull-wire is individually connected to and individually controlled at the distal portion, the joint movement force can be dynamically adjusted according to different pull-wire configurations. For example, the joint movement force can be recalculated, and the control signal for controlling the pull-wire can be dynamically adjusted based on the available pull-wires when a pull-wire is disconnected.

[0073]

[0089] In addition, the simple assembly of the pull-wires to the distal portion can provide freedom in designing the pull-wire configuration. For example, the number or combination of pull-wires can be dynamically selected or adjusted to meet different performance or design requirements. FIG. 15 shows various configurations of pull-wires for a robotic catheter system. In some embodiments, an integral structure (groove) for receiving the pull-wires can be pre-processed. For example, four grooves can be formed integrally with the catheter, and one or more pull-wires can be fixedly connected / crimped to one or more grooves selected from the plurality of grooves to form different configurations 1510, 1530. As shown in the example, any number of grooves / slots or any given subset of grooves / slots can be selected to receive or couple to the pull-wire at one end. Optionally, when a combination of slots / grooves is selected to be coupled to the corresponding pull-wire, a pull-wire configuration pattern can be formed, and the mapping relationship between the selected grooves / slots and the pull-wires can be transmitted to the control unit. Then, the control signal can be generated during joint movement based on the mapping relationship to achieve the desired joint movement force.

[0074]

[0090] In another example, the pre-machined grooves can have various configurations. For example, a three-pull wire configuration 1520 can have three grooves spaced approximately 120 degrees apart. Optionally, a virtual mapping algorithm can map a three-wire configuration to a four-wire configuration. The virtual mapping algorithm can also be used to update a new mapping relationship when one or more pull wires are not functioning properly / broken during operation. Such an integrated design of the pull wire configuration advantageously simplifies the assembly and manufacturing process while maintaining the kinematic dynamic performance of the catheter.

[0075] Guide wire with an expandable tip

[0091] In some embodiments, the guide wire can be used during a bronchoscopy procedure. The guide wire is typically first inserted well beyond the tip of the bronchoscope so as to enter the desired airway, and then the bronchoscope can be slid over the guide wire to enter the selected passage. Since the diameter of the guide wire is small compared to the diameter of the bronchoscope, the guide wire may not have sufficient rigidity and / or sufficient frictional force to firmly fix the guide wire within the airway.

[0076]

[0092] The guide wire of the present disclosure can have an expandable outer diameter feature at the tip. FIG. 16 shows an example of a guide wire 1600 with an expandable tip. The guide wire 1601 can be inserted through the working channel of the catheter / bronchoscope to assist in guiding induction in the airways within the lung. Optionally, the guide wire can extend beyond the tip of the catheter into the desired airway, and then the catheter can slide over the guide wire to reach the desired position. The expandable tip can be implemented using various suitable methods. For example, an additional component 1603 such as an expandable balloon can be positioned at or near the distal end of the guide wire. The balloon can be connected through the working channel to a balloon inflation source or pump for balloon inflation or deflation.

[0077]

[0093] Optionally, the guide wire may include perforations. The diameter of the deflated balloon may be equal to the diameter of the elongate arm (e.g., a bronchoscope catheter). Optionally, the diameter of the deflated balloon may be slightly larger than the elongate arm. The guide wire may be capable of moving distally or proximally. As a result, the guide wire may be attached to an air pump for injecting air into and extracting air from the guide wire to respectively inflate and deflate the balloon. During insertion of the guide wire into the airway, the balloon may remain deflated. The balloon is inflated by pumping air while reaching the appropriate location. When the bronchoscope reaches the desired forward position, the balloon may be deflated by discharging air to enable the guide wire to move forward. In some embodiments, the inflatable tip can be made of a foldable mesh structure using materials such as shape memory alloy (SMA), electroactive polymer (EAP), and ferromagnetic fluid, along with its corresponding inflation and deflation control mechanism. The fixing element can have any other form to ensure a firm fixation of the guide wire. For example, the fixing element can be a metal wire that is radially expandable or foldable. The fixing element can be actuated by a slide actuator that linearly slides, particularly to deploy the fixing element or return it to the folded position to change the position of the fixing element. The sliding motion of the actuator can be converted into a change in the position (state) of the fixing element (e.g., the fixing element expands radially in the deployed state to provide a structure for firmly fixing the guide wire in place, or conversely, the fixing element contracts radially and returns to the folded state).

[0078]

[0094] Figure 17 shows another example of a catheter tip design 1701. In the illustrated example, the tip 1701 may have a diameter larger than that of the bending section 1702 and / or the shaft 1703. The working channel 1708 may be deformable (e.g., expandable / crushable). The working channel 1708 may be formed of an elastic material (e.g., plastic) that can accommodate instruments with variable dimensions. For example, larger instruments such as biopsy instruments, treatment instruments, energy devices, etc. may expand the tip portion of the working channel when inserted into the working channel 1708.

[0079]

[0095] In the first example 1710, the LED light source or the light guide can be replaced after the endoscope reaches the target position. In the second example 1712, the LED light source 1711 can be embedded at the tip. In the third example 1713, the LED light source can be embedded at the tip while the light guide can be removable. The tip may include other electronic components such as a camera 1707 as described elsewhere in this specification. The endoscope may also include a handle portion 1704 similar to the handle as described elsewhere in this specification. For example, the handle portion may include a luer 1705 and an electrical interface 1706 for various functions.

[0080]

[0096] Although the preferred embodiments of the present invention are shown and described herein, it will be apparent to those skilled in the art that such embodiments are merely provided by way of example. Now, numerous variations, modifications, and substitutions will occur to those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be used in practicing the present invention. The following claims are intended to define the scope of the present invention, and it is intended that the methods and structures within the scope of these claims, as well as their equivalents, be covered by the claims.

Claims

1. An articulated flexible endoscope, a distal tip portion that is operable via a drive mechanism, a bending section connected to the distal tip portion at a first end and connected to a shaft portion at a transition interface, the bending section being articulated by one or more pull wires, the shaft portion including one or more load transfer tubes for accommodating the one or more pull wires and thereby improving the stability of the shaft portion comprising an articulated flexible endoscope.

2. The articulated flexible endoscope according to claim 1, wherein the distal tip portion includes a structure for receiving an imaging device, a position sensor, and an illumination device.

3. The articulated flexible endoscope according to claim 1, wherein each of the one or more pull wires is disposed inside the lumen of a respective one of the one or more load transfer tubes.

4. The articulated flexible endoscope according to claim 1, wherein the bending section is bent in two or more directions by the one or more pull wires.

5. The articulated flexible endoscope according to claim 1, wherein the one or more load transfer tubes are firmly fixed to the transition interface and have a length greater than the length of the shaft portion.

6. The articulated flexible endoscope according to claim 1, wherein the one or more load transfer tubes have a non-linear configuration.

7. The articulated flexible endoscope according to claim 1, wherein the one or more load transfer tubes have a helical configuration.

8. The articulated flexible endoscope according to claim 1, wherein the shaft portion includes a tube having an integrally formed structure for varying the rigidity of the shaft portion.

9. The articulated flexible endoscope according to claim 1, further including a deformable working channel.

10. Further including a handle portion, the handle portion including one or more components configured to process image data, provide power to one or more electronic components located at the distal tip portion, or establish communication with an external device.

11. The articulated flexible endoscope according to claim 10, wherein the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism.

12. The articulated flexible endoscope according to claim 11, wherein the interface is an electrical interface and a mechanical interface.

13. The articulated flexible endoscope according to claim 10, wherein the handle portion includes a mechanical control module for interfacing with a perfusion system or a suction system.

14. A disposable endoscope, comprising: A distal tip portion including an imaging device, a position sensor, and an illumination device; A bending section connected to the distal tip portion at a first end and to a shaft portion at a second end, the bending section being articulated by one or more pull wires; The shaft portion including one or more load transfer tubes for accommodating the one or more pull wires and thereby improving the stability of the shaft portion. A disposable endoscope.

15. The disposable endoscope according to claim 14, wherein the distal tip portion includes a structure for receiving the imaging device, the position sensor, and the illumination device.

16. The disposable endoscope according to claim 14, wherein the imaging device, the position sensor, and the illumination device are arranged in a compact configuration.

17. The disposable endoscope according to claim 14, wherein the one or more load transfer tubes have a length greater than the length of the shaft portion.

18. The disposable endoscope according to claim 14, wherein each of the one or more pull wires is disposed inside the lumen of a respective one of the one or more load transfer tubes.

19. The disposable endoscope according to claim 14, wherein the one or more pull wires are movable relative to the one or more load transfer tubes.

20. The disposable endoscope according to claim 14, wherein the bending section is bent in two or more directions by the one or more pull wires.

21. The disposable endoscope according to claim 14, wherein the one or more load transfer tubes have a non-linear configuration.

22. The disposable endoscope according to claim 14, wherein the one or more load transfer tubes have a helical configuration.

23. The disposable endoscope according to claim 14, wherein the shaft portion includes a tube having an integrally formed structure for changing the rigidity of the shaft portion.

24. The disposable endoscope according to claim 14, further including a deformable working channel. **Claim 25** The disposable endoscope according to claim 14, further comprising a handle portion, the handle portion including one or more components configured to process image data, provide power to the imaging device, the position sensor, and the illumination device, or establish communication with an external device. **Claim 26** The disposable endoscope according to claim 25, wherein the handle portion includes an interface configured to couple the handle portion to an instrument drive mechanism. **Claim 27** The disposable endoscope according to claim 26, wherein the interface includes an electrical interface and a mechanical interface. **Claim 28** The disposable endoscope according to claim 27, wherein the mechanical interface is configured to detachably couple the handle portion to the instrument drive mechanism.

Images