Methods and systems for disposable endoscopes

Abstract

An endoscope device is provided. The device includes an elongated member including a proximal end and a distal end, and a camera located at the distal end of the disposable elongated member, one or more external guide elements configured to guide articulation movement of the distal end of the elongated member, and each of the one or more external guide elements is controlled individually, and a handle assembly detachably attached to the proximal end of the elongated member.

Description

[0001] Quote

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 032,140, ​​filed May 29, 2020, and U.S. Provisional Patent Application No. 63 / 033,404, filed June 2, 2020, each of which is incorporated herein by reference in its entirety. Background Technology

[0003] Endoscopy has a wide range of applications in the diagnosis and treatment of various conditions, including medical conditions. In common endoscopic diagnostics, one or more separate instruments may be used in conjunction with an endoscope for biopsies or other treatments. Instruments are typically supplied as separate devices from the endoscope. These instruments may include, for example, mechanical tools such as graspers, scissors, baskets, snares, curettes, or advanced instruments such as laser fibers, suture tools, balloons, shredders, various implant or stent delivery devices, etc. Endoscopes and instruments are often manufactured by different equipment manufacturers. Even when they are manufactured by the same entity, endoscopes and instruments are often produced as separate devices due to the cost and expensive main components of the endoscope.

[0004] Endoscopes are traditionally reusable, which may require thorough cleaning, disinfection, and / or sterilization after each procedure. In many cases, cleaning, disinfection, and sterilization may involve corrosive treatments to kill bacteria and / or viruses. Such processes can also be very demanding on the endoscope itself. Therefore, the design of such reusable endoscopes can often be complex, especially in ensuring that the endoscope can withstand such stringent cleaning, disinfection, and sterilization protocols. Such reusable endoscopes may often require regular maintenance and repair.

[0005] Low-cost, single-use medical devices designated for single-use have become popular for instruments that are difficult to clean properly. Single-use, single-use devices are packaged in sterile packaging to avoid the risk of pathogenic cross-contamination such as HIV, hepatitis, and other pathogens. Hospitals generally welcome the convenience of single-use, single-use products because they no longer need to worry about product aging, overuse, breakage, malfunction, and sterilization. Traditional endoscopes often include a handle used by the operator to manipulate the endoscope. For single-use endoscopes, this handle often encloses the camera, expensive electronics, and mechanical structures proximally to transmit video and allow the user to manipulate the endoscope via a user interface. This can result in high costs for single-use endoscope handles. Summary of the Invention

[0006] This document recognizes the need for endoscopes that allow for the performance of surgical procedures or diagnostic operations with improved performance and cost-effectiveness. It also recognizes devices and systems incorporating endoscopes that can be disposable and may not require extensive cleaning processes. This disclosure provides low-cost, single-use articulated endoscopes for diagnostic and therapeutic applications in a variety of fields, such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, otolaryngology, gastrointestinal endoscopy, neurosurgery, hysteroscopy, cystoscopy, electrocautery, and various other applications. It should be noted that the provided endoscopic systems can be used for a variety of minimally invasive surgical procedures, therapeutic or diagnostic procedures involving various types of tissues, including the heart, bladder, and lungs, as well as other anatomical regions of the patient's body, such as the digestive system (including, but not limited to, the esophagus, liver, stomach, colon, and urinary tract), or the respiratory system (including, but not limited to, the bronchi and lungs), and various other systems.

[0007] In one aspect, this disclosure provides an apparatus comprising: an elongated member including a proximal end and a distal end, wherein a camera is located at the distal end of the elongated member, and the elongated member including at least a portion of a control unit for controlling the hinge of the distal portion of the elongated member; and a handle assembly detachably attached to the proximal end of the elongated member via an interface, wherein the handle assembly includes electronics for processing data transmitted from the camera.

[0008] In some embodiments, the handle assembly is reusable, and the interface between the handle assembly and the proximal end of the elongated member provides an electrical connection. In some embodiments, the interface includes a locking mechanism for securing the mechanical connection between the handle assembly and the proximal end of the elongated member. In some embodiments, the elongated member is single-use, and the user interface for the control unit is located at the proximal end of the elongated member. In some cases, the user interface includes a knob, lever, or button. In some cases, the mechanical structure for flow management is located at the proximal end of the elongated member.

[0009] In some embodiments, the elongated member has adjustable stiffness or a hinge affecting the distal portion. In some cases, the elongated member includes a reinforcing element, and the stiffness of the elongated member is adjusted by adjusting the length of the reinforcing element inserted into the elongated member.

[0010] In another aspect, this disclosure provides a device comprising: an elongated member including a proximal end and a distal end, wherein a camera is located at the distal end of the elongated member; one or more external guide elements configured to guide articulated movement of the distal end of the elongated member, the one or more external guide elements being individually controlled; and a handle assembly detachably attached to the proximal end of the elongated member. In some embodiments, the elongated member is disposed within one or more external guide elements and is movable relative to one or more external guide elements.

[0011] In some embodiments, each of the one or more external guide elements includes a hinge control mechanism for controlling the hinge of the respective external guide element. In some embodiments, the bending direction of the distal end of the elongated member is adjusted by adding or moving the one or more external guide elements or by configuring the bending direction of the one or more external guide elements relative to each other. In some embodiments, at least one of the one or more external guide elements is pre-bent.

[0012] In another aspect, this disclosure provides a device comprising: an instrument for performing a defined surgical procedure, the instrument including a cavity for receiving the endoscope; and the endoscope including a camera located at a distal tip of the endoscope, wherein the endoscope includes a hinge control mechanism for controlling the hinge of the device. In some embodiments, the instrument is an endotracheal tube or a Foley catheter. In some embodiments, the instrument and endoscope are disposable.

[0013] In another aspect, this disclosure provides an apparatus comprising: an elongated member including a proximal end and a distal end, wherein a camera is located at the distal end of the elongated member, and wherein the elongated member includes a hinged segment formed by at least one or more fluid access holes; and a handle assembly detachably attached to the proximal end of the elongated member, wherein the handle assembly includes electronics for processing image data transmitted from the camera.

[0014] In some embodiments, the handle assembly includes an electromagnetic (EM) sensor to detect the direction of gravity. In some cases, this direction of gravity is determined based on sensor data collected from an EM sensor located on the handle assembly and an EM sensor located at the distal end of the elongated member. In some cases, this direction of gravity is used to correct the view of image data. In some embodiments, the device also includes a fluid shield attached to the proximal end of the elongated member.

[0015] Additional aspects and advantages of this disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the disclosure are shown and described. As will be appreciated, this disclosure is capable of other and different embodiments, and several details thereof can be modified in various obvious respects without departing from this disclosure. Therefore, the drawings and description should be considered illustrative in nature and not restrictive.

[0016] Incorporation

[0017] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent, or patent application is specifically and individually indicated by reference. Where a publication, patent, or patent application incorporated by reference contradicts the disclosure contained herein, this specification is intended to supersede and / or give precedence to any such contradictory material. Attached Figure Description

[0018] The novel features of the invention are set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description of illustrative embodiments in which the principles of the invention are utilized, along with the accompanying drawings (also referred to herein as “drawings” and “figures”), wherein:

[0019] Figure 1 A schematic diagram of an exemplary proximal endoscope device is shown.

[0020] Figure 2 An exemplary single-use endoscope with a built-in interface is shown according to some embodiments of the present disclosure.

[0021] Figure 3 Examples of catheters or endoscope axes with working or fluid channels are shown.

[0022] Figure 4 An example of a reusable handle that connects to a disposable catheter or endoscope shaft is shown.

[0023] Figure 5 An example of a disposable catheter or endoscope shaft that is detachably coupled to the handle is shown.

[0024] Figure 6 An example of an interface with a secure connection is shown.

[0025] Figure 7 An example of a reusable handle assembly protected by a curtain is shown.

[0026] Figure 8Various examples of endoscopic devices including flow management features are shown.

[0027] Figure 9 Various exemplary embodiments of an endoscope with a hinged section are shown.

[0028] Figure 10 Various examples of single-use articulated endotracheal tubes or Foley tubes with articulation are shown.

[0029] Figure 11 An example of an articulated internal guide that can be assembled with an existing endotracheal tube or Foley tube is shown.

[0030] Figure 12 An example of an integrated device combining an articulated water sprayer and a pulverizer with a single-use endoscope is shown.

[0031] Figure 13 An example of an endoscope with an integrated positioning / position sensor is shown.

[0032] Figure 14 An example of an endoscope is shown, which is provided with external guiding elements for maneuverability and control.

[0033] Figure 15 Examples of endoscopic devices with external guiding elements according to some embodiments of the present disclosure are shown.

[0034] Figure 16 An example of an endoscope with an external guiding element is shown.

[0035] Figure 17 Various examples of articulated control mechanisms for endoscopes and / or external guide elements are shown.

[0036] Figure 18 and Figure 19 Examples of single-use endoscopes (i.e., hysteroscopes, cystoscopes, resection scopes) with articulated axes for diagnostic purposes are shown.

[0037] Figure 20 Examples of various low-cost designs for hinged shafts are shown.

[0038] Figure 21 An exemplary system module is shown.

[0039] Figure 22 An example of a single-use fluid shield is shown to prevent patient bodily fluids from splashing onto the handle or operator.

[0040] Figure 23 An example of the system's image stitching capabilities is shown.

[0041] Figure 24 This shows an example of control via the hinge on the shaft of the handle. Detailed Implementation

[0042] While various embodiments of the invention have been shown and described herein, it will be readily understood by those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0043] The embodiments disclosed herein can be combined in one or more of a variety of ways to provide improved diagnosis and treatment to patients. For example, the disclosed embodiments can be combined with existing methods and devices to provide improved treatment, such as with known methods for lung diagnosis, surgery, and surgery of other tissues and organs. It should be understood that any one or more structures and steps as described herein can be combined with any one or more additional structures and steps as described herein with the methods and devices, the accompanying drawings and supporting text providing a description according to the embodiments.

[0044] Whenever the terms "at least," "greater than," or "greater than or equal to" precede the first value in a series of two or more values, the terms "at least," "greater than," or "greater than or equal to" apply to each value in that series. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0045] Whenever the terms “no more than,” “less than,” or “less than or equal to” precede the first value in a series of two or more values, the terms “no more than,” “less than,” or “less than or equal to” apply to each value in that series. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0046] As used herein, a processor includes one or more processors, such as a single processor or multiple processors in a distributed processing system. A controller or processor as described herein generally includes a tangible medium for storing instructions for implementing steps of a process, and the processor may include one or more of, for example, a central processing unit, programmable array logic, gate array logic, or field-programmable gate array. In some cases, one or more processors may be programmable processors (e.g., a central processing unit (CPU) or microcontroller), digital signal processors (DSPs), field-programmable gate arrays (FPGAs), and / or one or more advanced RISC machine (ARM) processors. In some cases, one or more processors may be operatively coupled to a non-transitory computer-readable medium. The non-transitory computer-readable medium may store logic, code, and / or program instructions executable by one or more processor units to perform one or more steps. The non-transitory computer-readable medium may include one or more memory units (e.g., removable media or external storage such as an SD card or random access memory (RAM)). One or more methods or operations disclosed herein may be implemented in hardware components or combinations of hardware and software (e.g., ASICs, special-purpose computers, or general-purpose computers).

[0047] While exemplary embodiments may be applicable to urology, gynecology, rhinology, otology, laryngoscopy, gastroenterology with endoscopes, combined devices including endoscopes and instruments, and endoscopes with positioning features, those skilled in the art will understand that this is not intended to be limiting, and the devices described herein can be used in other therapeutic or diagnostic procedures and other anatomical areas of the patient's body, such as the eyes, stomach, intestines, ovaries, etc., in the form of: neuroendoscopes, neuroscopes, eyeglasses, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, nephroscopes, gastroscopes, duodenoscopes, cholangioscopes, laparoscopes, hysteroscopes, uroscopes, cystoscopes, rectoscopes, colonoscopes, arthroscopes, salivary endoscopes, orthopedic endoscopes, etc., and used in combination with various tools or instruments.

[0048] As used herein, the terms distal and proximal can generally refer to the location from a device reference and can be the opposite of an anatomical reference. For example, the distal location of an endoscope or catheter can correspond to the proximal location of a patient's slender member, and the proximal location of a bronchoscope or catheter can correspond to the distal location of a patient's slender member.

[0049] The devices or endoscopes described herein include elongated portions or components, such as catheters. Unless the context otherwise requires, the terms "elongated component," "catheter," and "endoscope axis" are used interchangeably throughout this specification. The elongated component can be placed directly into a body cavity or body cavity.

[0050] The endoscope disclosed herein can be used to examine the internal anatomical structures of objects, such as animal and human objects. Objects may include animals, such as pigs, mice, dogs, mammals, rodents, monkeys, and other animals. Objects may include human objects, such as patients. The methods and systems provided herein can be used for the diagnosis and / or treatment of objects and / or parts of objects.

[0051] In some embodiments of this disclosure, a low-cost, single-use articulated device for diagnostic and therapeutic purposes is provided. Single-use devices, such as single-use endoscopes, may not require postoperative cleaning, sterilization, and disinfection. Single-use or disposable devices can be disposed of after the surgical procedure, saving users valuable time and effort. For example, a single-use endoscope is used only once per surgical procedure, thus avoiding reprocessing after the procedure, the risk of cross-contamination between patients, and reducing infection. In some cases, a single-use endoscope may include a disposable catheter detachably attached to a reusable handle assembly.

[0052] In some disclosed embodiments, the endoscope may include an optimized design of a proximal or handpiece assembly at a lower cost. The handpiece assembly may be reusable and provided at a lower cost. The proximal or handpiece assembly may have a unique design that positions expensive modules within reusable sections. Furthermore, the proximal end may include an improved interface mechanism between the single-use catheter and the handpiece assembly, thereby providing improved modularity and / or convenient assembly. In some embodiments, the endoscope and handpiece assembly are connected via an interface. For example, the interface may provide electrical connection, mechanical connection, and / or illumination alignment.

[0053] Figure 1 A schematic diagram of an exemplary proximal end 101 is shown. The proximal end may refer to the proximal end of an endoscopic device. For example, the proximal end may include a handle assembly or a handle. The terms "handle assembly" and "handle" are used interchangeably throughout the specification. The proximal end may be connected to a flexible, hinged shaft or conduit 108.

[0054] Navigating intricate and tortuous paths is crucial for the success of an examination, minimizing patient pain, side effects, risks, or sedation. Modern endoscopes incorporate methods for deflecting the distal tip of the endoscope to follow the path of the structure being examined, minimizing deflection or friction on surrounding tissues. A control cable or cord is carried within the endoscope body to connect a hinged section near the distal end to a set of control knobs at the proximal endoscope handle. By operating these control knobs, the operator is typically able to manipulate the endoscope during insertion and guide it to the area of ​​interest.

[0055] In some cases, the proximal end may include an articulation control user interface 102, such as a lever or knob for controlling the distal articulation of the endoscope. The articulation control user interface can be used to control the bending movement of the distal portion of the catheter in one or more degrees of freedom (e.g., articulation). For example, a rotary knob may be connected to one or more pull wires or control cables to control the orientation of the distal articulation structure, and a lever may pull or release one or more pull wires to control the orientation of the articulation structure.

[0056] In some cases, the proximal end may include a connector such as a lure or valve 103 for air, vacuum, or fluid control and / or flow management. For example, tubular assembly 107 may be connected to the proximal end via a lure or valve. Any suitable irrigation and aspiration system can be connected to the endoscope via connector 103 (e.g., lure or valve). For example, an irrigation system may infuse a liquid such as saline, and an aspiration system may remove mucus, saline, or other substances from the airway.

[0057] The proximal end 101 may include electronics for an illumination source and imaging control 104. Images / videos captured by a camera located at the distal end may be transmitted via a cable 106 connected to the imaging control module 104 located at the proximal end. The imaging control module may include one or more processors and electronics for processing image signals or performing other operations related to image acquisition. For example, the distal tip may include an imaging device such as a camera and an illumination element such as an optical fiber. The camera may have any display resolution, such as Full HD, HD, Video Graphics Array (VGA), or below VGA. The camera may be located at the distal end, and the cable 106 may be connected to the camera to provide power and for data transmission. Light may be transmitted via an optical transmission material or optical fiber. In some cases, the proximal end may include one or more user control elements (e.g., buttons) or other user interfaces 105 for controlling one or more functions of the endoscope.

[0058] Any description of the camera, articulated control mechanism, control cable, flow system, etc., can be applied to other endoscopes, systems, and handles as described later in this document.

[0059] Figures 2 to 8 Various examples of the proximal end of a single-use endoscope according to some embodiments of this disclosure are shown. Figure 2An exemplary single-use endoscope 201 including interface 204 is shown. The single-use endoscope 201 can be detachably connected to handles 202, 203 via interface 204. In some cases, handles 202, 203 can be reusable, and the endoscope 201 can be disposable. In some cases, the endoscope 201 and handles 202, 203 can be detachably attached, allowing the endoscope to be released from the handle and disposed of after a single use, while the handle can be reused.

[0060] Interface 204 can provide both mechanical and electrical connections. Interface 204 may include both mechanical and electrical interfaces. Mechanical interface 204 can allow the endoscope to be releasably coupled to the handle. For example, the handle can be attached to the endoscope via a quick-release mechanism such as a magnet or a spring-loaded lever. In some cases, the endoscope can be manually coupled to or released from the handle without the use of tools.

[0061] In some cases, interface 204 can provide an electrical connection, allowing power and data transmission between the electronics located on the handpiece and the endoscope. Interface 204 can have a uniform design that allows a disposable endoscope to be connected to either the wireless handpiece 202 or the wired handpiece 203. For example, the endoscope can be connected to both the wireless handpiece and the wired handpiece via the same interface.

[0062] As described above, the handle assembly can be a wireless handle 202 or a wired handle 203. The handle assembly may include a mating interface 208 to be connected to an interface 204. For example, interface 204 may include pins soldered to an electronic board such as a printed circuit board (PCB). For example, a receptacle connector (e.g., a female connector) is provided on the handle as mating interface 208. In this case, when the endoscope is inserted into the handle, the connection between the pins and the connector can provide sufficient mechanical connection force between the endoscope and the handle, as well as power to the endoscope. In another example, the proximal circuit board may be inserted into a receptacle mating connector inside the handle. When this connection pair is connected, the optical transmission fiber at the proximal end of the endoscope can be aligned with a light source in the handle. This interface 204 can provide electrical connection, mechanical connection, and illumination alignment. For example, power can be supplied to the camera by a wired cable terminating at interface 204. In some cases, the cable may be in a harness that supplies power to the camera and illumination elements or other circuitry at the distal tip of the endoscope. The camera and / or light source can be powered from the power supply 205 located in the handle section via a wire, copper wire, or any other suitable device extending through the length of the endoscope. Alternatively, video and images captured by the camera can be transmitted wirelessly. It should be noted that any description of the interface applies to the devices, endoscopes, and systems described later herein.

[0063] Wireless handle assembly 202 may include, for example, a power source (e.g., battery pack) 205 and a wireless communication module 206. Battery pack 205 may be rechargeable or disposable. The power source may provide power to the endoscope and / or its electronic components (e.g., a camera). Wireless communication module 206 may transmit video signals via secure wireless mechanisms such as WiFi, Bluetooth, RF communication, or other forms of communication. The wireless signals may be received by a computer and displayed as real-time video from the endoscope. For example, images or videos captured by a camera may be broadcast to multiple devices or systems. In some cases, the handle may be designed so that the operator cannot see the wires or the wires are not exposed to the operator. Wired handle assembly 203 may provide wired communication, such as cable 207, to external devices / systems (e.g., a computer, a monitor). In some cases, wired cable 207 may provide power to the endoscope device and transmit video. Any description of wired / wireless handles and their components (e.g., power source, communication module) may apply to other embodiments of the handle described elsewhere herein.

[0064] Figure 3 An example of a catheter or endoscope shaft 301 having a working channel or fluid channel 304 is shown. The catheter or endoscope shaft 301 may include an interface that can be connected to... Figure 2 The interface described herein is identical, allowing the endoscope to be detachably connected to a reusable wireless handle 302 or wired handle 303. This provides an interface with improved flexibility and compatibility across different types of endoscopes and different handle designs.

[0065] In some implementations, the proximal end may have an improved design for the articulation control module at a reduced cost. For flexible endoscopes, the distal portion and / or articulated section of the endoscope is typically controlled via a pull / drive cable extending from the distal end to the proximal end. The reusable handle assembly of this disclosure can retain the performance of controlling the endoscope articulation while reducing costs. For example, components such as complex mechanical parts or expensive electronics (e.g., image processing units, circuit boards) can be separated from low-cost components (e.g., mechanical control user interfaces, connectors, or flow management features) and located on either the disposable endoscope or the reusable handle, respectively, to achieve an overall cost reduction.

[0066] Figure 4 and Figure 5 An exemplary handle with different articulation control modules is shown. The handle can be designed such that one or more mechanical control modules (such as Luer for engaging the irrigation / suction system and levers / knobs for articulation control, etc.) can be located in the endoscope, while the electronics for imaging control can be stored in the handle.

[0067] Figure 4 Examples of reusable handles 402, 403 connected to a disposable catheter or endoscope shaft 401 are shown. Reusable handles (such as wireless handle 402 and wired handle 403) can be used with... Figure 2 and Figure 3 The same handle assembly is described herein. In the illustrated example, the user interface of the articulation control module 405 may be located on the proximal portion of the endoscope. One or more mechanical elements (such as levers) may be located on the proximal portion of the endoscope, allowing the user to pull the drive cable to articulate / bend the tip of the flexible catheter or endoscope shaft 407. In some cases, a connector (e.g., Luer 406) for engaging the irrigation / aspiration system may also be located on the proximal portion of the endoscope. This advantageously moves low-cost mechanical components (such as connector 406, articulation control user interface 405) to a disposable endoscope, while retaining expensive electronics in the reusable handle 402, thereby reducing the cost of the handle. The flexible catheter or endoscope shaft may include a mating feature 404 at the proximal portion for attachment to the handle. In this case, the primary functions of the handle may include providing power, illumination, and imaging control to the endoscope.

[0068] In some cases, a portion of the mechanical component can be moved onto the catheter or endoscope axis. Figure 5 An example is shown where a disposable catheter or endoscope shaft 501 is detachably coupled to a handle 502. In the example shown, the disposable catheter or endoscope shaft 501 may not include any mechanical user interface (e.g., a lever or knob for articulation control). The flexible catheter or endoscope shaft 501 may have a simple mechanical mechanism as part of an articulation drive module at the proximal end of the endoscope. The mechanical mechanism may be a gear 503 directly connected to the drive cable and further connected to a mating mechanism (e.g., gear 506) located at the handle. At the reusable handle 502, the mating mechanism, such as gear 506, may be connected to a mechanical user interface (e.g., lever 507) located at the handle 502. In this case, at least a portion of the articulation control mechanism (e.g., gear 506), the mechanical control user interface (e.g., lever 507), the wireless communication module 508, and the battery pack 509 may be located at the reusable handle, while a portion of the articulation control mechanism (e.g., gear 503) is located at the catheter or endoscope shaft.

[0069] The disposable flexible catheter or endoscope shaft 501 can have the same Figure 2 or Figure 3 The same electrical interface described herein. Alternatively, the disposable flexible catheter or endoscope shaft 501 may have a separate electrical interface, such as cable 505, which connects to the reusable handle for power supply and transmission of images / video.

[0070] The electrical and mechanical interfaces between the catheter or endoscope shaft and the handle are critical for signal integrity. This disclosure provides a proximal design including interfaces with secure connections.

[0071] Figure 6 An example of an interface with a secure connection between an endoscope shaft and a handle is shown. As shown in the example, a disposable catheter or endoscope shaft 601 can be connected to a reusable handle 602 via a card edge connector, with a PCB board 603 and a mating connector 604 residing on either side of the catheter and handle. In some cases, the interface may include a pair of magnets 606 to facilitate the connection between the catheter and the reusable handle. In some cases, the electrical interface may include a pair of pin connectors 607 and 609. For example, the electrical interface may include a probe-type connector 608 and a board with surface contact pads 610.

[0072] The mechanical interface may include a locking mechanism to secure the mechanical connection between the handle assembly and the proximal end of the elongated member. For example, the mechanical interface may be secured by a locking mechanism 605. In some examples, the locking mechanism may include a quick-release mechanism. In some examples, one or more mechanical connection features may include a snap-fit ​​mechanism. Any suitable locking mechanism may be used, such as a snap-fit, lock, clamp, guide rail, mechanical deformation, mechanical fastening, interlocking connection, flange and / or other instrument, tool and / or mechanism or any combination thereof. This can advantageously ensure the reliability of both electrical and mechanical connections.

[0073] As shown in the figure, the battery pack can be a disposable battery 611 or a rechargeable battery 612. In some cases, the battery can be charged via a wireless coil 613. For example, the charging station can be configured to transmit charging power to the endoscope shaft or handle using inductive transmission. The primary coil 613 can be integrated into the charging station to transmit inductive energy to a secondary coil integrated in the handle. The secondary coil can be used to charge one or more batteries in the handle.

[0074] Aseptic management of these reusable handles becomes crucial in aseptic clinical procedures. In some embodiments, the provided device may also include a sterile curtain to maintain the sterility of the handle during operation. In some cases, the sterile curtain is a curtain bag. In some cases, the sterile curtain further covers the handle's cable.

[0075] Figure 7 An example of a reusable handle assembly protected by a curtain is shown. As shown in the example, a disposable catheter or endoscope shaft 701 is connected to a wireless reusable handle 702 covered by a sterile curtain 703. The sterile curtain 703 may be a sterile bag wrapped around the handle assembly 702, providing the physician with a complete sterile device.

[0076] In some cases, when the handle assembly includes a user interface (e.g., lever, knob) for articulated control, the sterile curtain 704 may have an opening 704 to receive the handle assembly 702 and be resealable during operation 705. For example, the sterile curtain 704 may include an outlet port with a sealing flange, allowing the user access to the articulated control device. Any suitable means can be used to seal the opening. For example, tape, zippers, buttons, or sliders can be used to provide a sealing barrier.

[0077] Traditional endoscopic devices may offer flow control features, such as Luer valves or valves, for connection to irrigation and / or aspiration systems. Irrigation systems can inject liquids such as saline, while aspiration systems can remove mucus, saline, or other substances from the airway. Figure 8 An example of a conventional endoscope device 801 is shown, including a valve 803 for managing flow. An inlet 804 can be connected to the working channel of the endoscope via a connector 802. Flow management features (e.g., valve 803) can be integrated into the connector and are typically provided with a single-use endoscope 801.

[0078] In some implementations, this single-use endoscope may provide alternative flow management features located at a reusable inlet. For example... Figure 8 As shown, flow management features such as pneumatic 806 can be provided to inlets for air, vacuum, or fluid control. Moving flow management feature 806 from single-use connector 805 to reusable inlets can advantageously reduce the cost of disposable endoscopes.

[0079] Traditional endoscopes may have a flexible axis that can be articulated via control cables or pull wires. For example, the distal ends of one or more pull wires can be anchored or attached to a distal portion of the flexible axis, allowing operation of the pull wires by the control unit to apply force or tension to the distal portion, which can be manipulated or articulated (e.g., up, down, pitch, yaw, or any direction in between) at least a distal portion (e.g., a flexible segment) of the flexible axis. Traditional articulated structures often require additional elements, such as multiple interconnected segments, pivots, hinges, etc., to achieve the articulation. However, due to the complex geometry, such articulated structures can be difficult to clean and / or sterilize.

[0080] In one aspect of this disclosure, an improved articulation segment design for an endoscope is provided. This articulation segment can consist of low-cost, easily mass-producible articulation features, allowing the distal end of the endoscope to bend in the desired direction via one or more control cables. This articulation segment avoids the use of articulated joints with complex geometries, thus facilitating sterilization and cleaning.

[0081] Figure 9Various exemplary embodiments of endoscopes with articulated sections are shown. In some cases, the distal tip of the catheter or endoscope axis is hinged / bent with two or more degrees of freedom to provide the desired camera view. As shown in Example 901, a camera 907 is located at the distal end of the catheter or endoscope axis 906. The camera's line of sight 908 can be controlled by controlling the hinge at the distal end. In some embodiments, instead of or in addition to the hinge, the camera's line of sight can be adjusted by means of optical elements (e.g., prisms) 909, thereby simplifying the mechanical structure of the articulated joint. In some embodiments, the angle of the camera 907 can be adjustable, allowing the line of sight to be adjusted without hinged the distal tip of the catheter or endoscope axis. For example, the camera can be oriented at an angle (e.g., tilted) relative to the axis of the endoscope tip.

[0082] In some cases, the distal tip of the catheter or endoscope axis may be driven by multiple cables 910. The distal end of the cable may be anchored to the tip of the endoscope, such that when force is applied, the articulated section / neck portion 911 can bend in one or more directions. The cables, as shown in Example 902, may be used in conjunction with an individually adjustable camera as described in Example 901.

[0083] In another example 914, the articulated section of the catheter or endoscope axis 914 may include an articulated structure, such as a slit / slot 915. The articulated structure may include one or more slit / slot structures formed at the neck / distal portion, allowing the neck portion to be articulated. By introducing a slit or slot structure directly into the axis or neck portion of the endoscope, articulation can be achieved without additional components (e.g., articulated joints, hinges, pivots, etc.), which advantageously simplifies the geometry of the articulated section, thereby reducing the cost of disposable endoscopes.

[0084] The articulation of a flexible catheter or shaft can be influenced by the design of the articulation segment or the stiffness of the catheter. In conventional designs, the stiffness or articulation segment is fixed and cannot be adjusted during use. In some embodiments, the elongated member of this disclosure may have adjustable stiffness or adjustable articulation segment to influence the articulation of the distal portion. In some cases, the camera may be located at the distal tip of the inner shaft 912, which may be flexible / compliant and easily bent, as shown in Example 903. The catheter or endoscope shaft shown in 903 may also include an outer sheath 913 to provide sufficient support and stiffness to the inner shaft 912. The outer sheath may be stiffer or more rigid than the inner shaft. To achieve articulation, the distal portion of the inner shaft 912 may extend to the distal end of the outer sheath, allowing the extension to bend to the desired degree and direction. In some cases, the degree of bending can be controlled at least by controlling the length of the inner shaft portion extending onto the outer sheath.

[0085] In some cases, adjustable hinges or adjustable stiffness can be achieved using a sliding stiffener 918, as shown in Example 905. For example, the shaft may include a stiffening element, and the stiffness of the shaft is adjusted by adjusting the length of the stiffening element inserted into the shaft. The shaft 916 may be, for example, a plastic tube including a channel 917. The stiffener 918 may be inserted inside the channel 917 and may slide relative to the shaft 916 to achieve a hinge. The assembly 919 may have variable stiffness along its length. The stiffness can be adjusted by adjusting the length of the stiffener 918 inserted into the shaft. For example, greater stiffness can be achieved by inserting a longer stiffener into the shaft.

[0086] Endotracheal intubation and Foley catheters are widely used for airway management and bladder emptying. An endotracheal intubation tube is a flexible plastic tube inserted through the mouth into the trachea (airway) to assist the patient's breathing. The endotracheal tube is then connected to a ventilator, which delivers oxygen to the lungs. In urology, Foley catheters are flexible tubes that clinicians insert through the urethra into the bladder to drain urine. Due to the lack of stiffness and articulation at the tip, such devices have been difficult to insert into patients, especially when inserted through the natural curvature of the patient's anatomy, such as from the nose / mouth to the throat, or from the urethra to the prostate. There is a desire to provide articulated cannulas or Foley catheters with direct visualization to facilitate operability and anatomical confirmation.

[0087] In one aspect of this disclosure, a low-cost, single-use articulated endotracheal cannula and an articulated Foley catheter are provided. The articulated endotracheal cannula and the articulated Foley catheter may also have visualization capabilities.

[0088] Figure 10 Various examples of single-use articulated endotracheal tubes or Foley catheters with articulations 1003, 1004 are shown. Articulated endotracheal tubes or Foley catheters with visualization can be designed to achieve improved performance at a reduced cost. As described above, a conventional endotracheal tube 1001 or Foley catheter 1002 may include a balloon 1005 and a suction tube 1006. The provided single-use articulated endotracheal tubes 1003 and single-use articulated Foley catheters 1004 may include a camera 1009 located on the distal portion of the tube. The camera 1009 may be connected to the proximal end via a cable 1008 for transmitting image signals. The articulation of the tube may be controlled by one or more pull wires 1007. Similar to single-use endoscope designs, the distal end of the pull wire may be anchored to the distal portion of the tube to apply force.

[0089] In some implementations, articulation and visual capabilities of the endotracheal tube or Foley catheter can be provided by a separate articulation device. Figure 11An example of an articulated internal guide 1101 is shown, which can be assembled to an existing endotracheal cannula 1107 or Foley cannula 1108 to provide articulation and vision capabilities.

[0090] In some cases, articulation and visual capabilities may be provided by a separate articulated internal guide 1101. The articulated internal guide 1101 can be inserted through the passage of an existing endotracheal cannula 1107 or Foley catheter 1108. The articulated internal guide 1101 may have a tubular body, including a cylinder with an outer wall and a central lumen. The outer wall may be adapted to the passage of an existing endotracheal cannula 1107 or Foley catheter 1108. The articulated internal guide 1101 may include a camera 1105 located at its distal portion, and image signals may be transmitted via cable to a display 1102 located at its proximal end. The articulation may be achieved by means of one or more pull wires 1104, such that the articulated segment 1106 of the internal guide can be bent when force is applied to the distal portion of the internal guide via the pull wires. The articulated segment and articulation control mechanism of the internal guide may be the same as described elsewhere herein. In some cases, the proximal end of the internal guide may also include a user interface 1103 for articulated control (e.g., lever, knob). In some cases, the instruments (e.g., endotracheal tubes or Foley catheters) and endoscopes are disposable.

[0091] In some embodiments, this disclosure provides endoscopes with integrated instruments. Traditionally, instruments such as grippers, scissors, baskets, snares, curettes, laser fibers, suture tools, balloons, shredders, and various implant or stent delivery devices are provided as separate components from the endoscope. These instruments can be used in various endoscopes with different types of endoscopes (e.g., neuroendoscopes, neuroscopes, spectacles, otoscopes, rhinoscopes, laryngoscopes, gastroscopes, esophagoscopes, bronchoscopes, thoracoscopes, pleuraloscopes, angioscopes, mediastinoscopes, nephroscopes, gastroscopes, duodenoscopes, cholangioscopes, choledochoscopes, laparoscopes, hysteroscopes, uroscopes, cystoscopes, rectoscopes, colonoscopes, arthroscopes, salivary endoscopes, and orthopedic endoscopes). For example, a shredder can be used in gynecology and rhinology to treat polyps. A balloon can be used in rhinology for sinus surgery. Certain implants or stents can be used to treat fluid behind the tympanic membrane (myringotomy), open sinus ostia, or treat benign prostatic hyperplasia (BPH) by opening a prostate cannula. Suturing mechanisms can be used for suturing within the stomach. Laser fibers can be used for ablation or coagulation in urological, gynecological, and various other conditions.

[0092] Traditional endoscopes can be large (e.g., with an outer diameter of several millimeters to several centimeters). To accommodate any of these instruments, a working channel within the endoscope is typically required to allow the instruments to pass through. In some cases, multiple working channels are needed to allow multiple instruments to pass through simultaneously. This design can lead to an increase in the overall size of the endoscope. There is a desire to provide integrated instruments for single-use endoscopes. This disclosure provides an integrated endoscope and instruments with a reduced overall device size.

[0093] In some embodiments, a low-cost, single-use endoscope is provided, which integrates instruments for treatment in a variety of applications (e.g., bronchoscopy, urology, gynecology, arthroscopy, otolaryngology, gastrointestinal endoscopy, etc.).

[0094] Figure 12 Examples of integrated devices combining instruments and single-use endoscopes are shown. In the examples shown, the combined device may include an articulated water jet device or a pulverizer combined with a single-use endoscope. As shown in Example 1201, the articulated water jet device may include a water jet 1207 and one or more drive mechanisms 1206 (e.g., cables) for articulation. The pulverizer 1202 may include an outer tube 1210 and an inner tube 1211. In some cases, the pulverizer 1202 may also include one or more drive mechanisms 1209 (e.g., cables) for articulation.

[0095] The articulated water jet 1201 can be integrated with the endoscope 1203 to form an integrated device 1204. The integrated device 1204 can be single-use and has a built-in camera 1212 located at the distal end of the device. The camera 1212 can reside adjacent to the distal end of the water jet device. Similarly, the pulverizer 1202 can be integrated with the endoscope 1203 to form an integrated device 1205. This device may include a camera 1213 located at the distal end of the integrated device.

[0096] Traditional flexible endoscopes can have long, flexible axes. Because the axes are flexible, it is difficult to know the exact position of the flexible endoscope tip inside the patient once it is inserted. Although flexible endoscopes provide a first-person / camera view of the clinical site inside the patient, the positioning of the flexible endoscope tip relative to a global reference frame or the patient's body is unavailable. Without knowing the exact position of the flexible endoscope tip relative to the patient's body, surgical procedures become difficult to perform and can potentially cause clinical harm to the patient being treated. There is a desire to provide positioning capabilities for endoscopes.

[0097] In some embodiments, low-cost endoscopes with positioning features are provided. The endoscope may be single-use and can be used for treatment in a variety of applications (e.g., bronchoscopy, urology, gynecology, arthroscopy, otolaryngology, gastrointestinal endoscopy, etc.). The provided endoscope may integrate one or more positioning or position sensors to accurately track the position of the distal tip of the endoscope. Various types of position sensors, such as electromagnetic (EM) sensors and FBG-fiber Bragg gratings, can be integrated into the endoscope. Endoscopes with positioning capabilities can be designed to have a smaller overall size and can be provided at a lower cost.

[0098] Figure 13 Examples of endoscopes 1301, 1302, 1303, and 1304 with integrated positioning / positioning sensors are shown. In the illustrated examples 1301 and 1302, the endoscope may or may not include a working channel 1309. The endoscope may include one or more integrated positioning sensors, such as an electromagnetic (EM) sensor 1306. One or more sensors may be embedded in the distal tip of the endoscope, and an EM field generator may be positioned adjacent to the patient's torso during the procedure. The EM field generator can position the EM sensors in 3D space, or it can position and orient the EM sensors in 5D or 6D space. This can provide visual guidance to the operator as they advance the endoscope toward the target site. Endoscopes 1301 and 1302 may also include a distally located camera 1305, and one or more articulation drive mechanisms 1307 (e.g., cables) to control the articulated segment 1308 of the endoscope. In some cases, the endoscope's catheter may be semi-rigid or compliant, making it difficult to accurately track catheter deformation. For example, a semi-rigid endoscope without a working channel 1303 or with a working channel 1304 can have an integrated EM sensor, allowing the position of the distal tip of the catheter to be tracked.

[0099] In some implementations, an external endoscope guide element with articulation capability may be provided for navigation. Figure 14 An example of an endoscope 1401 is shown, which is provided with external guide elements 1402, 1403, and 1404 for manipulation and control. In some cases, the conduit or shaft 1401 may include a camera 1406, a positioning sensor 1405, a working channel 1407, or other structures / components described elsewhere herein. In some cases, existing endoscopes 1401 may have limited articulation capabilities, such as a lack of built-in articulation features or insufficient rigidity. The endoscope 1401 may be assembled with one or more modular guide elements 1402, 1403, and 1404 for maneuverability and controllability.

[0100] In some embodiments, each external guide element 1402, 1403, 1404 may have a tubular body comprising a cylinder having an outer wall and a central cavity. In some cases, each external guide element 1402, 1403, 1404 may include an articulation control mechanism (e.g., a cable) 1408 and an articulation segment. Each external guide element can be individually controlled for articulation. In some cases, one or more external guide elements may be detachably attached to a handle assembly in the conduit 1401. The handle assembly may be the same as those described elsewhere herein. For example, a user interface (e.g., a lever) for controlling the articulation of one or more external guides may be located at the handle assembly or a disposable elongated member.

[0101] The lumen of the external guide element can be adapted to receive a catheter or an internal guide element. For example, a catheter or endoscope shaft 1401 can be inserted through the lumen of the external guide element 1402 and can be secured to at least the distal portion of the external guide element 1402. In some cases, more than one external guide may be concentrically assembled with the endoscope to provide additional articulation. For example, a first external guide 1402 having a first outer diameter (R1) can allow bending in a first direction, a second external guide 1403 having a second outer diameter (R2, R2>R1) from outside the first external guide can provide bending in a direction different from the first direction, and a third external guide 1404 having a third diameter (R3, R3>R2) from outside the second external guide can provide bending in a direction different from the first and second directions, such that the endoscope 1401 is maneuverable in at least three directions.

[0102] The hinge can be conveniently adjusted by configuring multiple external guide elements. The bending direction of the distal end of the axis can be adjusted by adding or moving one or more external guide elements or by configuring the bending directions of one or more external guide elements relative to each other. For example, the degrees of freedom of bending (e.g., the number of bending directions) can be adjusted by adding or removing a certain number of external guides. In another example, the overall bending direction of the endoscope can be adjusted by configuring individual bending directions associated with each external guide relative to each other. For example, each external guide element can have one degree of freedom for bending, and various combinations of degrees of freedom for bending can be achieved by adjusting the bending axis of the external guide element relative to the axis or another bending element. This is beneficial for providing modular design and fine control of endoscope navigation. For example, when the bending axes / directions of different external guide elements are aligned with each other, a greater degree of bending can be achieved in that direction, while additional degrees of bending freedom can be achieved when the bending axes / directions of different external guide elements are not aligned.

[0103] Figure 15An example of an assembled endoscope 1501 with one or more external guide elements is shown. The external guide element 1503 forms a channel for insertion of a catheter or endoscope shaft 1502. In some cases, multiple external guide elements, such as the external guide 1503 and the internal guide 1504, are articulated and can be individually controlled. This can advantageously allow adjustment of the catheter's articulation capability by adding / removing external guide elements temporarily.

[0104] In some cases, at least one external guide is hinged, while another can be pre-bent to a predetermined shape. Figure 16 An example of an endoscope assembled with an external guide element is shown. The external guide 1601 may be pre-bent around at least the neck segment or distal portion, and the internal guide 1602 may be hinged.

[0105] Figure 17 Various examples of articulated control mechanisms 1701, 1702, and 1703 for endoscopes and / or external guides are shown. The articulated control mechanism may be located proximal to the external guide. In some cases, control mechanism 1704 may be a passive preloading system, such as a spring-based mechanism. The passive preloading system may be attached to a cable wound around a winch so that the passive preloading system can control the slack tension in the cable. During endoscopic operation, friction between the cable and the winch may allow the drive motor to rotate the winch to wind in a length of cable, and the winch friction can apply maximum tension to the cable, which depends exponentially on the total angle of the cable wound around the winch. Therefore, the forces from the passive preloading system (e.g., spring force from the spring) and the tension in the slack cable can remain relatively low while still generating the high tension required for the endoscope to clamp under resistance or for other movements. When the motor torque on the winch is zero, the winch can rotate freely, and the passive preloading system can pull in the cable to prevent slack. Low relaxation tension can reduce the force required to manipulate the endoscope and reduce cable friction, which is particularly problematic in medical devices with curved or flexible shafts.

[0106] In some cases, the articulation control mechanism may include a set of motors 1705 actuated to rotate a set of cables that drive the endoscope. This set of motors can drive the cables via pulley fittings 1708. The number of pulleys may vary depending on the cable configuration. In some cases, one, two, three, four, or more cables may be used to articulate the endoscope. Any other suitable mechanical element besides / replacing pulleys, such as a prismatic linear connector or slider 1707, may be used as part of the control mechanism 1706.

[0107] The endoscope disclosed herein can be used to examine the internal anatomy of objects (e.g., animal and human objects). Objects may include animals such as pigs, mice, dogs, mammals, rodents, monkeys, and other animals. Objects may include human objects such as patients. The methods and systems provided herein can be used for the diagnosis and / or treatment of objects and / or parts of objects.

[0108] In some embodiments of this disclosure, a low-cost, single-use articulated device for diagnosis and treatment is provided. Single-use devices (such as single-use endoscopes) may not require postoperative cleaning, sterilization, and disinfection. Single-use or disposable devices can be disposed of after the procedure, saving users valuable time and effort. For example, a single-use endoscope is used only once per surgical procedure, thus avoiding postoperative reprocessing or the risk of cross-contamination between patients and reducing infection. In some cases, a single-use endoscope may include a disposable catheter detachably attached to a reusable handle assembly.

[0109] In particular, the endoscope of this disclosure may include an optimized design for a cost-reducing proximal or handpiece assembly. The handpiece assembly can be reusable and provided at a lower cost. The proximal or handpiece assembly may have a unique design that places expensive modules within the reusable portion. Furthermore, the proximal end may include an improved interface mechanism between the single-use catheter and the handpiece assembly, thereby providing improved modularity and / or convenient assembly. In some embodiments, the endoscope and handpiece assembly are connected via an interface. For example, the interface may provide electrical connection, mechanical connection, and / or illumination alignment.

[0110] Figure 18 Examples of a single-use endoscope disposable section 1801, a single-use attachable fluid shield 1803, and a reusable handle 1802 are shown. The disposable endoscope section may include a shaft 1816 and a distal tip, in which a low-cost camera module 1805 and an illumination module 1806 reside. The camera module can be tilted at a given angle within the integrated device, thereby allowing a side view of the endoscope. The camera can be tilted at any angle, such as at least 0 degrees, 12 degrees, 18 degrees, 30 degrees, or any number in between.

[0111] Axis 1816 may include a channel 1807 along its length, which may serve as a water channel in a diagnostic device or an instrument and water channel in a therapeutic device. One or more fluid inlets 1808 may be present along the axis of the disposable portion. The fluid inlets may be of any shape, such as circular, elliptical, triangular, etc. Liquid (e.g., water) may return to the proximal end through one or more inlets.

[0112] The shaft may include hinge sections 1804 and 1809. In some cases, one or more fluid inlet holes 1808 as described above may also enable the hinge. One or more fluid inlet holes may be part of the hinge section. Details regarding the hinge section are... Figure 2 As described in the text.

[0113] In some cases, the proximal end may include an interface 1812. This interface may include mechanical, electrical, and / or fluid management interfaces. For example, the interface may include an articulated control user interface 1810, such as a lever or knob for controlling the distal articulation of the endoscope. In another example, the interface may include a connector such as a Luer or valve 1811 for air, vacuum, or fluid control and / or flow management. Any suitable irrigation and aspiration system can be connected to the endoscope via connector 1811 (e.g., a Luer or valve). For example, an irrigation system may inject liquids such as saline, and an aspiration system may remove mucus, saline, or other substances from the airway. In further examples, the interface may include electronics for illumination sources and imaging control. For example, an imaging control module may include one or more processors and electronics for processing image signals or performing other operations related to image acquisition.

[0114] Interface 1812 may include mechanical and electrical connections. The interface may include both mechanical and electrical interfaces. The mechanical interface may allow the endoscope to be releasably coupled to a handle or control mechanism (e.g., an instrument drive mechanism). For example, handle 1802 may be attached to the endoscope via a quick-release mechanism (e.g., a magnet and a spring-loaded level). In some cases, the endoscope may be manually coupled to or released from the handle without the use of tools. In some cases, handle connection 1813 may provide an electrical connection, allowing power and data transmission between the electronics located on the handle and the endoscope.

[0115] In an alternative implementation, the handle can be reused with an integrated motor that provides rotational or linear motion to the shaft / flexible device. For example... Figure 19 As shown, endoscope 1901 can also be releasably coupled to handle 1902 via an instrument drive mechanism connected to 1913. The instrument drive mechanism may include a set of motors actuated to rotate a set of pull cables for catheter / shaft 1905. Endoscope interface 1912 may be mounted on the instrument drive mechanism such that its pulley fitting 1915 is driven by this set of motors (connected to the shaft of motor 1916). The number of pulleys may vary depending on the pull cable configuration. In some cases, one, two, three, four, or more pull cables may be used to articulate catheter / shaft 1905.

[0116] The reusable handle 1902 can be controlled by the user via an interface with an electric joystick and buttons, commanding the movement of the motor 1916, which then transmits the movement to the single-use device via an interface 1912 coupled to the connection 1913 of the reusable handle.

[0117] Return to reference Figure 18 The device may optionally include a single-use, attachable fluid shield 1803. The disposable portion 1801 can be attached to a handle 1802 with or without the fluid shield. The fluid shield can also be used for... Figure 19 The embodiments described herein. Details regarding the fluid shield will be described later in this document. In some embodiments, the handle can track the direction of gravity by including an electromagnetic (EM) tracking device with an embedded EM sensor 1810 in a disposable part or inside the handle. Details regarding gravity direction tracking will be described later in this document.

[0118] The handle can be wireless or wired. A wireless handle may include, for example, a power source (e.g., a battery pack) and a wireless communication module. The battery pack may be rechargeable or disposable. The power source can provide power to the endoscope and / or its electronic components (e.g., a camera). The wireless communication module can transmit video signals via secure wireless mechanisms such as WiFi, Bluetooth, RF communication, or other forms of communication. The wireless signals can be received by a computer and displayed as real-time video from the endoscope. For example, images or videos captured by a camera can be broadcast to multiple devices or systems. In some cases, the handle may be designed so that the operator cannot see the wires or has no wires exposed to the operator.

[0119] In some cases, the handle can be connected to an external system (e.g., a computer, monitor, etc.) via wired communication (e.g., cable 1814). In some cases, the wired cable 1814 can provide power to the endoscopic device and transmit video. Any description of the wired / wireless handle and its components (e.g., power supply, communication module) can be applied to other embodiments of the handle described elsewhere herein.

[0120] Low-cost articulated design

[0121] Traditional endoscopes may have a flexible axis that can be articulated via control cables or pull wires. For example, the distal ends of one or more pull wires can be anchored or attached to a distal portion of the flexible axis, allowing operation of the pull wires by the control unit to apply force or tension to the distal portion, which can be manipulated or articulated (e.g., up, down, pitch, yaw, or any direction in between) at least a distal portion (e.g., a flexible segment) of the flexible axis. Traditional articulated structures often require additional elements, such as multiple interconnected segments, pivots, hinges, etc., to achieve the articulation. However, due to the complex geometry, such articulated structures can be difficult to clean and / or sterilize.

[0122] In one aspect of this disclosure, an improved articulation segment design for an endoscope is provided. The articulation segment can consist of low-cost, easily mass-producible articulation features, which allows the distal end of the endoscope to bend in the desired direction via one or more control cables.

[0123] Figure 20 An example of an articulated shaft design is shown. This articulated shaft design can advantageously reduce costs, allowing the disposable portion of the endoscope to be used only once. In some embodiments, one or more pull wires 2008 can be attached to the distal portion of the endoscope. In the case of multiple pull wires, pulling one wire at a time can change the orientation of the distal tip, tilting it upward, downward, left, right, or in any directly desired direction. In the case of using only one pull wire, the internal channel 1807 can have a greater bending stiffness than the outer axis of the endoscope. The internal channel acts as a natural spring, reacting to the movement of the distal tip's outer axis. When a single pull wire is released, the endoscope tends to straighten due to the presence of the internal channel and its greater bending stiffness.

[0124] In one embodiment, the hinged portion of the shaft may include a hinge joint 2001. The distal portion of the shaft may have a hinge-shaped cutout. It mates the proximal side of the shaft with a complementary shape.

[0125] In one embodiment, the hinge portion 2002 of the shaft may have a helical shape. The hinge portion may be cut into a helical shape using laser or other manufacturing methods. At the top of the helical portion, a jacket is added to form a smooth surface of the shaft.

[0126] Another embodiment of the articulated section 2003 can be formed by using a short outer tube to join the distal segment (e.g., the distal portion) and the proximal segment of the shaft. The outer tube can connect one end of the distal segment to one end of the proximal segment. Compared to the distal and proximal segments of the shaft, the outer tube may have less stiffness. For example, the outer tube may be formed of a softer (less stiff) material. When the pull wire is pulled, the softer outer tube may deform and bend due to its lower stiffness. Depending on the attachment position of the pull wire anchored to the distal segment, the device can be pulled in a predetermined direction.

[0127] In another embodiment, the hinge segment 2004 can be achieved by cutting the material of the shaft. The cut in the material can be designed so that the shape of the shaft can be maintained by the rest of the structure. When one or more wires are pulled, the hinge segment with less material / cut shape may deflect in a predetermined direction due to lower structural strength. In some cases, such a cut can also serve as the aforementioned fluid inlet.

[0128] In other embodiments, the hinge segment 2005 can be formed by varying the wall thickness of the shaft 2005. The hinge segment of the shaft may have a variable wall thickness in cross-section. As shown in the examples, the hinge segment may have cross-sectional views 2006 and 2007, with the wall having a variable thickness such that the thickness in at least one direction differs from the thickness in another direction within the cross-section. One or more pull wires may be embedded in the wall of the distal tip of the shaft. When the pull wires are pulled, the shaft may deflect to a direction substantially aligned with the direction of the thinner wall (e.g., indicated by the arrow). The material of the shaft (e.g., silicone, soft nylon, etc.) can be selected to ensure that the shaft does not kink or break.

[0129] Figure 24 An example of hinge control via a mechanical control mechanism is shown. For example, the mechanical control mechanism may include a pair of latching mechanisms 2605 and 2604 residing respectively in the disposable part and the handle. In some cases, the latching mechanisms may be a pair of magnets. The latching element in the disposable part can be attached to a pull wire with appropriate tension. When the disposable part is attached to the handle, the pair of latching elements latch. The latching element on the handle is connected via an internal mechanical structure to a user interface such as an actuation knob. The actuation knob may be, for example, a pull trigger 2603 or a rotary knob 2604, which may enable relative rotation between the distal portion 2601 and the proximal portion 2602 of the handle 1802. The actuation knob may be self-locking to retain pull force to the hinge axis.

[0130] The articulation control mechanism can be configured to control the amount of articulation (e.g., deflection degree) and / or the direction of deflection. The articulation direction and angle can be controlled by pulling a selected cable through rotation of a knob. By using a sensor such as a digital counter to track the amount of knob rotation, the amount of articulation / angle can be input into a computer that tracks the articulation in real time.

[0131] Single-use water shield

[0132] Aseptic boundaries are crucial for surgical procedures. Figure 22An example of a sterile, single-use water shield design is shown. A low-cost design is provided, enabling the water shield to be used only once. Prior to the procedure, the water shield 1803 can be assembled onto the handle 1802, creating a sterile boundary. The distal portion of the water shield is sterile. The disposable portion 1801 of the endoscope is inserted into the handle along with the water shield.

[0133] As shown in Example 2401, the water shield can be a medical-grade plastic shield molded into a semi-dome shape. This water shield is related to... Figure 18 The same fluid shield described herein. The water shield may have an opening to receive a disposable portion of the endoscope. The disposable portion of the endoscope can be inserted into the handle through this water shield. Along the periphery of the opening (e.g., a central hole), there may be one or more protrusions 2402 that can engage with the interface of the disposable portion, which is further connected to the handle.

[0134] In another example, the water shield 2403 may be substantially cup-shaped. The water shield may include a central aperture allowing a disposable portion of the endoscope to pass through for attachment to the handle. The water shield may also include one or more engagement holes 2404 surrounding the central aperture. These engagement holes may connect to mating holes on the handle, thereby preventing reasonable movement of the water shield relative to the handle. Once the disposable portion is attached to the handle, the water shield is further secured at the interface between the handle and the proximal end of the shaft without movement.

[0135] Gravity compensation

[0136] During endoscopic surgery, the camera view is inside the patient and entirely surrounded by anatomical landmarks. Since an external view of the patient's body, i.e., their gestures, is unavailable, understanding the direction of gravity relative to the camera view is crucial. The system provided may be able to track the direction of gravity by correlating the device's position and orientation with external equipment.

[0137] Figure 21An example of a system with gravity orientation tracking capability is shown. In some cases, the camera may be located at the distal tip of the axis. The system may include at least a disposable part 1801, a handle 1802, and a computer 2301 with a display. In some cases, the gravity orientation detected by the gravity sensor is used to correct the view of the image data. An example of tracking the gravity orientation is by including an electromagnetic (EM) tracking device 2302 with an embedded EM sensor 1810 within the disposable part or handle. One or more sensors may be embedded at the distal tip of the endoscope and close to the camera. In some cases, an EM field generator may be located next to the patient's torso during the procedure. The EM field generator can position the EM sensor in 3D space, or can position and orient the EM sensor in 5D or 6D space. The EM device communicates with the computer via cable or wirelessly. The image on the screen can be corrected based on gravity information provided in the software running on the computer 2301. For example, when the camera's flip angle and the corresponding view of the image can be corrected based on sensor data to align with the direction of gravity, the patient's posture relative to the direction of gravity can be input by a computer to allow for fine-tuning of the gravity compensation accuracy.

[0138] Alternatively, the visual tracking system 2303 may allow one or more features 2304 of a single part to be tracked relative to the direction of gravity. These one or more features may include: custom graphics, structural markings, geometry on the device, or any other visually recognizable features.

[0139] In another embodiment, gravity tracking features may include the use of gravity sensors or other sensors, such as IMUs, accelerometers, Hall sensors, inertial sensors, potentiometers, encoders, etc. Such sensors may be located in the disposable part, the handle, or both. In some cases, the direction of gravity is determined based on sensor data collected from an EM sensor located on the handle assembly and an EM sensor located at the distal end of the elongated member. In some cases, if there is relative motion between the distal and proximal parts, the gravity sensor may be located on the distal and proximal parts of the handle, respectively. These sensors can detect the direction of gravity or relative motion between the disposable part and the handle or parts within the handle, and then transmit the information to processor 2301. There may be one pair or more pairs of sensors. The patient's posture can be input into the computer by a physician. The provided system can track changes in the direction of gravity via software running on the computer.

[0140] In some cases, the direction of gravity can be tracked using anatomical landmarks (e.g., openings). In other cases, certain clinical landmarks are known to be located in specific, known positions, such as two openings on the left and right sides of the patient, or the verumontanum at the back of the patient. Software image capture and algorithms can correct the direction of gravity each time a camera view captures such clinical landmarks. Image segmentation algorithms can be used to identify these landmarks and generate rotation (correction) angles relative to the front or back of the patient. Real-time images or videos can be rotated based on this information to align with the direction of gravity. In some cases, the physician may input a specified direction of gravity relative to the landmark orientation before starting the surgical procedure, at the start of the software algorithm.

[0141] Image stitching methods

[0142] Single-use endoscopes can utilize low-cost camera modules at the distal tip. Due to their low-cost nature, these camera modules may have a limited field of view (FOV), such as 90, 100, 110, or 120 degrees. Endoscopic surgery sometimes requires the surgeon to have a good understanding of the entire anatomy and an overview of the entire surgical site. One way to achieve this with low-cost, limited FOV camera modules is through image stitching in software. The stitched image in the panoramic view can be used to magnify the FOV, giving the surgeon a sense of the overall picture.

[0143] Figure 23 An example of a dynamic overview of the entire surgical site is shown on a computer monitor 2301. The view displayed by the central solid circle 2501 is similar to a classic endoscopic view in a camera. Possible lesions 2502 are identified along with several solid black dots. When the endoscope is hinged, the view shifts to one of the dashed circles, 2505. In this view 2505, the same feature 2507 is also identified. By automatically tracking these features 2507 and by taking into account the amount of hinge from the handle, as well as the position and orientation of the tracking device via EM tracker 302 or vision tracker 303, the relative positions of circles 2501 and 2505 are calculated, and the two images are then stitched together. Correcting the stitching method may require knowledge of the device position and orientation, the amount of hinge, and the same features displayed in different views.

[0144] Similarly, by scanning the entire anatomical structure, one or more dashed circles, such as 2505, are stitched together using features from different views. The outer double dashed circle 2506 displays a complete view of the anatomical structure. As the distal camera moves within the anatomical structure, images or videos are acquired at high frequencies (e.g., at least 22 fps, 30 fps, 60 fps, or higher). Any changes to the anatomical structure or features can be displayed on the screen in real time to maintain the precision and accuracy of the stitching. As shown in the example, openings 2503 and 2504 may not be present in the classic view of endoscope 2501 but can be seen through the stitched image 2506, which helps the physician to have a good understanding of the landmarks.

[0145] While preferred embodiments of the invention have been shown and described herein, it will be readily understood by those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in carrying out the invention. The following claims are intended to define the scope of the invention, and the methods and structures within the scope of these claims, and their equivalents, are thereby covered.

Claims

1. An endoscopic device, comprising: An elongated member including a proximal end and a distal end, wherein a camera is located at the distal end of the elongated member, and wherein the elongated member is single-use and includes a hinged user interface for controlling a distal portion of the elongated member, the interface being located at the proximal end of the elongated member, wherein the hinged movement of the distal portion of the elongated member is about a first bending axis. A handle component, which is detachably attached to the proximal end of the elongated member via an interface, wherein the handle component is reusable and includes electronics for processing image data transmitted from the camera; as well as A first external guide element is detachably assembled to the elongated member. The first external guide element is concentrically connected to the elongated member such that the elongated member is positioned inside the first external guide element and is movable relative to the first external guide element. The first external guide element includes a hinge control mechanism and is individually controlled to bend the elongated member about a second bending axis, and the second bending axis is configurable relative to the first bending axis such that when the second bending axis is aligned with the first bending axis, the range of motion about the first bending axis increases, and when the second bending axis is not aligned with the first bending axis, the second bending axis is oriented in a different direction from the first bending axis, thereby providing additional bending degrees of freedom.

2. The endoscope device of claim 1, wherein the elongated member includes a reinforcing member, the reinforcing member being a slidable reinforcing rib inserted into a channel of the elongated member and sliding relative to the elongated member, and wherein the stiffness of the elongated member is adjusted by adjusting the length of the reinforcing member inserted into the elongated member.

3. The endoscope device of claim 1, wherein the interface between the handle component and the proximal end of the elongated member provides an electrical connection.

4. The endoscope device of claim 1, wherein the interface between the handle component and the proximal end of the elongated member includes a locking mechanism to secure the mechanical connection between the handle component and the proximal end of the elongated member.

5. The endoscope device of claim 1, wherein the user interface is located at the proximal end of the elongated member.

6. The endoscopic device of claim 5, wherein the user interface includes a knob, lever, or button for controlling the hinge of the distal portion of the elongated member.

7. The endoscope device of claim 5, wherein the user interface further comprises a mechanical structure for flow management of the endoscope device.

8. The endoscope device of claim 1, wherein the first external guide element is detachably assembled with the elongated member by being detachably attached to the handle component.

9. The endoscope device according to claim 1, further comprising a second external guide element having a third bending axis.

10. The endoscope device of claim 9, wherein each of the first and second external guide elements includes a hinge control mechanism for controlling the hinge of the respective external guide element about the first bending axis or the second bending axis.

11. The endoscope device of claim 9, wherein the first bending axis, the second bending axis and the third bending axis are different bending axes.

12. The endoscopic device of claim 1, wherein the degree of freedom for bending the distal end of the elongated member is adjusted by adding or moving an external guide element.

13. The endoscopic device of claim 1, wherein the first external guide element is pre-bent.

14. The endoscope device of claim 1, wherein the elongated member includes at least a hinged section formed by one or more fluid access holes.

15. The endoscope device of claim 1, wherein the handle component includes an electromagnetic sensor to detect the direction of gravity.

16. The endoscope device of claim 15, wherein the direction of gravity is determined based on sensor data collected from the electromagnetic sensor located at the handle component and the electromagnetic sensor located at the distal end of the elongated member.

17. The endoscopic device of claim 16, wherein the direction of gravity is used to correct the view of the image data.

18. The endoscopic device of claim 16, further comprising a fluid shield connected to the proximal end of the elongated member.

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