CN117479876A - Anti-buckling device and method for surgical system - Google Patents

Abstract

An anti-buckling device is provided. The buckling restrained device includes: a plurality of modular segments, and each modular segment includes a cap and a tube. The cap includes a support feature configured to support the elongated member, and the tube includes a coupling feature configured to engage a given modular segment with another modular segment.

Description

Anti-buckling device and method for surgical system

Citation(s)

The present application claims priority from U.S. provisional patent application number 63/181,105 filed on 28 of 2021 and U.S. provisional patent application number 63/195,432 filed on 1 of 2021, 6, each of which is incorporated herein by reference in its entirety.

Background

Endoscopic procedures use endoscopy to examine the interior of a hollow organ or body cavity. Unlike many other medical imaging techniques, endoscopes are inserted directly into organs. Flexible endoscopes that can provide instinctive manipulation and control are useful in the diagnosis and treatment of diseases that are accessible through any natural orifice in the body. Depending on the clinical indication, endoscopes may be designated as bronchoscopes, ureteroscopes, colonoscopes, gastroscopes, ENT scopes, and various other scopes.

Disclosure of Invention

It is recognized herein that a need exists for a minimally invasive system that allows for surgical procedures or diagnostic operations to be performed with improved reliability and stability. The present disclosure provides robotic surgical systems and devices that are well suited for performing medical procedures. The surgical system may include a low cost, single use articulatable endoscope for diagnosis and treatment in a variety of applications, such as bronchoscopy, urology, gynecology, arthroscopy, orthopedics, ENT, gastrointestinal endoscopy, neurosurgery, and a variety of other applications. The surgical system of the present disclosure may be a robotic endoscope system including an anti-buckling device. The buckling restrained device may improve stability and accuracy for controlling movement of the elongated member.

In some embodiments of the invention, the elongate member may be a catheter inserted into the patient and may be disposable. For example, the catheter portion may be designed to be disposable at low cost while maintaining surgical performance and function. It should be noted that the provided endoscopic system may be used in a variety of minimally invasive surgical procedures, therapeutic or diagnostic procedures involving various types of tissue including heart, bladder and lung tissue, and may be used in other anatomical areas of the patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract or respiratory system, including but not limited to the bronchi, lungs and other various organs.

In one aspect of the present disclosure, an anti-buckling device is provided. The buckling restrained device comprises: a plurality of modular segments, wherein each modular segment comprises a cap and a tube. The cap includes a support feature configured to support the elongated member and the tube includes a coupling feature configured to engage a given modular segment with another modular segment.

In some embodiments, the elongate member includes a proximal end and a distal end, wherein the proximal end is detachably attached to the robotic arm via the handle and the distal end is integrated with the imaging device, the position sensor, and the illumination device. In some cases, the distal end includes structure that receives the imaging device, the position sensor, and the illumination device. In some cases, the imaging device, the position sensor, and the illumination device are arranged in a compact configuration. In some cases, the handle is connected to a first end of the buckling restrained device. In some cases, the handle includes an interface configured to couple the handle to an instrument drive mechanism attached to the robotic arm. In some cases, the elongate member further comprises a curved section hinged by one or more pull wires.

In some embodiments, the support feature includes a first opening having a size that matches a size of the elongated member. In some embodiments, the support feature is configured to align a modular segment with an adjacent modular segment when the modular segment is in a collapsed state with the adjacent modular segment.

In some embodiments, the cap is releasably coupled to the tube. In some embodiments, the buckling restrained device further comprises a locking feature for preventing movement of the plurality of modular segments when they are in the collapsed state.

In another aspect, an anti-buckling device is provided that includes a helical rolling structure. The buckling restrained device comprises: a helical rolling structure formed from a sheet of material for supporting the elongate member; a first member connected to the distal end of the helical rolling structure; and a second member connected to the proximal end of the helical rolling structure. In some cases, the first and second members are releasably connected when the buckling restrained device is in the collapsed state.

In some embodiments, the material is paper or fabric. In some embodiments, the first component connects the buckling restrained device to a component at the patient bed. In some embodiments, the second component connects the buckling restrained device to the handle portion of the elongate member.

In some embodiments, the helical rolling structure provides continuous support for the elongated member. In some embodiments, the first member is connected to the distal end of the helical rolling structure via a third member. In some cases, the first member is connected to the distal end of the helical rolling structure via a third member. In some cases, the third component provides support for the distal end of the elongate member. In some cases, the third component includes a self-centering feature to assist in alignment when the buckling prevention device is in the collapsed state.

Other aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, wherein only illustrative embodiments of the disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

Incorporation by reference

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and/or take precedence over any such contradictory material.

Brief description of the drawings

The novel features of the invention are set forth with particularity 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 that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also referred to herein as "figures"), of which:

Fig. 1 illustrates an example of a robotic endoscope system according to some embodiments of the invention.

Fig. 2 shows an example of a robotic catheter assembly with an anti-buckling device.

Fig. 3 shows an example of an assembly of an anti-buckling mechanism and a handle.

Fig. 4 shows an example of an inspection scope handle and anti-buckling tube assembly.

Fig. 5 and 6 illustrate examples of an assembly of the buckling restrained device and catheter assembly.

Fig. 7 illustrates an example of multiple telescoping segments of an anti-buckling mechanism according to some embodiments of the present invention.

Fig. 8 and 9 show examples of modular segments.

Fig. 10 shows an example of a pipe member.

Fig. 11 shows another view of the tube part.

Fig. 12A shows an example of a cap member.

Fig. 12B shows an example of a tube component having a snap feature engaged with a cap component.

Fig. 13 shows an example of coupled modular segments.

Fig. 14-16 illustrate another example of a modular segment.

Fig. 17-18 illustrate examples of buckling restrained devices having locking features.

Fig. 19 shows an example of other locking features.

Fig. 20 and 21 show examples of the helical buckling restrained device in an extended state.

Fig. 22 shows the helical buckling prevention device in a collapsed state.

Fig. 23 shows a side view and a cross-sectional view of a helical buckling prevention device (in a collapsed state).

Fig. 24 shows an example of a catheter inserted into an anti-buckling device.

Fig. 25 and 26 illustrate examples of an assembly of the buckling restrained device and catheter assembly.

Fig. 27 shows an example of a buckling prevention device with a connector at the distal tip.

Fig. 28 shows a cross-sectional view of the buckling prevention device with a connector at the distal tip.

Detailed Description

While various embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Many changes, 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.

The present disclosure provides buckling restrained devices and methods for flexible elongate members in surgical systems. For example, one or more sections may bend or flex as the flexible portion of the catheter is inserted into the patient through the bronchoscope by the extension mechanism. In some cases, to prevent buckling of the catheter as the endoscope is advanced toward the patient, an buckling prevention mechanism may be coupled to the robotic endoscope (e.g., a handle portion of the endoscope) to support the catheter.

While the exemplary embodiments are primarily directed to articulating flexible endoscopes, those skilled in the art will appreciate that this is not intended to be limiting and that the anti-buckling devices and methods described herein may be used with other flexible devices and with various therapeutic or diagnostic procedures and various anatomical regions of a patient's body, such as the digestive system, including but not limited to the esophagus, liver, stomach, colon, urinary tract, or respiratory system, including but not limited to bronchi, lungs, and various other organs.

Whenever the term "at least", "greater than" or "greater than or equal to" occurs before the first value in a series of two or more values, the term "at least", "greater than" or "greater than or equal to" applies to each value in the series. For example, 1, 2, or 3 or more corresponds to 1 or more, 2 or 3 or more.

Whenever the term "no greater than", "less than" or "less than or equal to" occurs before the first value in a series of two or more values, the term "no greater than", "less than" or "less than or equal to" applies to each value in the series of values. For example, less than or equal to 3, 2, or 1 corresponds to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

As used herein, the terms "distal" and "proximal" generally refer to locations referenced from the device, and may be opposite anatomical references. For example, the distal position of the endoscope or catheter may correspond to the proximal position of the elongate member of the patient, and the proximal position of the endoscope or catheter may correspond to the distal position of the elongate member of the patient.

The systems described herein include an elongate portion or elongate member, such as a catheter. The terms "elongate member" and "catheter" are used interchangeably throughout this specification unless the context indicates otherwise. The elongate member may be placed directly into a body cavity or body lumen. In some embodiments, the system may further include a support device, such as a robotic manipulator (e.g., a robotic arm), to drive, support, position, or control movement and/or operation of the elongated member. Alternatively or additionally, the support device may be a handheld device or other control device, which may or may not include a robotic system. In some embodiments, the system may further include peripheral devices and subsystems, such as an imaging system, that will assist and/or facilitate navigation of the elongate member to a target site in the subject's body.

Existing anti-buckling mechanisms (e.g., telescoping mechanisms) may not have satisfactory performance and therefore the flexible portion of the catheter may still bend or buckle. For example, a conventional buckling restrained device may include a plurality of cylindrical tubes open at both ends. The diameter of the cylindrical element may be gradually increased. These cylindrical tubes may be coupled together and may collapse or expand within each other. The diameter of the cylinder having the smallest diameter is larger than the diameter of the elongated member, so that the elongated member can move forward when the cylinder is extended. The diameter difference allows the catheter to not be retracted when the anti-buckling device is retracted or removed. However, in sections where the diameter of the telescoping mechanism is much larger than the outer diameter of the catheter, the catheter may still buckle. For example, as the diameter of the cylinder increases, the elongate member will not contact the wall of the relatively larger tube until greater bending occurs.

The present disclosure provides an improved buckling restrained mechanism. The buckling restrained mechanism is used for preventing buckling of an insertion shaft or a catheter, and buckling restrained performance is improved. The anti-buckling mechanism may include a plurality of modular segments that extend and collapse to support catheter delivery as the catheter is inserted into and retracted from the patient. In some embodiments, each modular segment of the buckling restrained mechanism may include internal structure to achieve buckling restrained of the catheter during insertion and extraction, improving stability. The plurality of modular segments may be designed to allow for easy assembly and disassembly. For example, modular segments can be easily swapped out. In some cases, multiple modular segments may be coupled/decoupled without additional coupling means (e.g., adhesives, screws, etc.).

In some embodiments, multiple modular segments may be accidently extended, making it difficult to insert a catheter during operation. The plurality of modular segments may also fall out due to gravity. The provided anti-buckling mechanisms may include locking features to prevent unwanted extension.

In some embodiments of the present disclosure, robotic endoscope systems are provided for performing surgical procedures or diagnostics with improved performance at low cost. For example, a robotic endoscope system may include a steerable catheter, which may be fully disposable. Fig. 1 illustrates an example of a robotic endoscope system according to some embodiments of the invention. As shown in fig. 1, the robotic endoscope system may include a steerable catheter assembly 105 and a robotic support system 110 for supporting or carrying the steerable catheter assembly. The steerable catheter assembly may be an endoscope. In some embodiments, the steerable catheter assembly may be a single-use robotic endoscope. In some embodiments, the robotic endoscope system may include an instrument drive mechanism 103 attached to an arm of the robotic support system. The instrument drive mechanism may be provided by any suitable controller device (e.g., a handheld controller), which may or may not include a robotic system. The instrument drive mechanism may provide a mechanical interface and an electrical interface for the steerable catheter assembly 105. The mechanical interface may allow the steerable catheter assembly 105 to be releasably coupled to the instrument drive mechanism 103. For example, the handle portion of the steerable catheter assembly may be attached to the instrument drive mechanism via quick mount/release means (e.g., magnets, spring loaded levels, etc.). In some cases, the steerable catheter assembly may be manually coupled to or released from the instrument drive mechanism without the use of tools. The instrument drive mechanism may be used to control the elongate member or robotic catheter assembly in two or more degrees of freedom (e.g., articulation).

The robotic support system may include a robotic arm 107 and a movable cart 109. The robotic arm 107 may initiate positioning of a robotic catheter assembly or other robotic instrument. In some cases, the user interface, the robotic control module, and the robotic arm may be mounted to a movable cart. The mobile cart may include various elements such as a rechargeable power supply in electrical communication with a power panel that provides a charging port for the portable electronic device, a converter, a transformer, and a surge protector for a plurality of AC and DC outlets as power sources for on-board devices including one or more computers storing dedicated software for the user interface. The robotic arm, robotic endoscope system, user interface, catheter assembly, and other components of the system may be the same as those described in International application No. PCT/US20/65999 filed on 18/12/2020, the disclosure of which is incorporated herein by reference in its entirety.

Steerable catheter assembly 105 may include a flexible elongate member coupled to a handle portion. The robotic endoscope system may include a buckling prevention device 101 for preventing buckling of the elongated member during use. The buckling restrained device will be described in more detail below.

Fig. 2 shows another example of a robotic catheter assembly with an anti-buckling device 201. The steerable catheter assembly may include a handle portion 211, which handle portion 211 may include components configured to process image data, provide power, or establish communication with other external devices. For example, the handle portion 211 may include circuitry and communication elements that support electrical communication between the steerable catheter assembly and the instrument drive mechanism 221, as well as any other external systems or devices. In another example, the handle portion 211 may include circuit elements, such as a power source for powering the electronics of the endoscope (e.g., camera and LED lights). In some cases, the handle portion may be in electrical communication with the instrument drive mechanism 221 via an electrical interface (e.g., a printed circuit board) such that image/video data and/or sensor data may be received by a communication module of the instrument drive mechanism and may be transmitted to other external devices/systems. Alternatively or additionally, the instrument drive mechanism 221 may provide only a mechanical interface. The handle portion may be in electrical communication with a modular wireless communication device or any other user device (e.g., a portable/handheld device or controller) to transmit sensor data and/or receive control signals.

The steerable catheter assembly may include a flexible elongate member 213 (i.e., a catheter) coupled to the handle portion 211. In some embodiments, the flexible elongate member can include a shaft, a steerable tip, and a steerable section. The steerable catheter assembly may be a single-use robotic endoscope. In some cases, only the elongate member may be disposable. In some cases, at least a portion of the elongate member (e.g., shaft, steerable tip, etc.) may be disposable. In some cases, the entire steerable catheter assembly, including the handle portion and the elongate member, may be disposable. The flexible elongate member and the handle portion are designed such that the entire steerable catheter assembly can be disposed of at low cost.

The robotic endoscope may be releasably coupled to the instrument drive mechanism 221. The instrument drive mechanism 221 may be mounted to an arm of a robotic support system or to any of the actuation support systems described above. The instrument drive mechanism may provide a mechanical interface and an electrical interface for the robotic endoscope. The mechanical interface may allow the robotic endoscope to be releasably coupled to the instrument drive mechanism. For example, the handle portion of the robotic endoscope may be attached to the instrument drive mechanism via quick mount/release means (e.g., magnets and spring loaded levels). In some cases, the robotic endoscope may be manually coupled to or released from the instrument drive mechanism without the use of tools. In some embodiments, the instrument drive mechanism 221 may include a set of motors that are actuated to rotationally drive a set of pull wires of the catheter. The handle portion 211 of the catheter assembly may be mounted to the instrument drive mechanism such that its pulley assembly is driven by the set of motors. The number of pulleys may vary depending on the wire configuration. In some cases, one, two, three, four, or more pull wires may be used to articulate the catheter.

The handle portion may be designed to allow the robotic endoscope to be disposable at reduced cost. For example, conventional manual and robotic endoscopes may have a cable at the proximal end of the endoscope handle. The cables typically include illumination fibers, camera video cables, and other sensor fibers or cables, such as EM sensors or shape sensing fibers. Such complex cables can be expensive, increasing the cost of the endoscope. The provided robotic endoscope may have an optimized design such that simplified structures and components may be employed while retaining mechanical and electrical functions. In some cases, the handle portion of the robotic endoscope may be of a cable-less design while providing a mechanical/electrical interface for the catheter.

In some cases, the handle portion may be a housing or may include components configured to process image data, provide power, or establish communication with other external devices. In some cases, the communication may be a wireless communication. For example, the wireless communication may include Wi-Fi, radio communication, bluetooth, IR communication, or other types of direct communication. Such wireless communication capability may allow the robotic bronchoscope to operate in a plug and play manner and may be conveniently disposed of after a single use. In some cases, the handle portion may include circuit elements, such as a power source for powering electronics (e.g., cameras and LED light sources) disposed within the robotic bronchoscope or catheter.

The handle portion may be designed with the catheter so that cables or optical fibers may be eliminated. For example, the catheter section may employ a design with a single working channel that allows instruments to pass through a robotic bronchoscope and low cost electronics (e.g., chip-on-tip camera), illumination sources (e.g., light Emitting Diodes (LEDs)) and EM sensors that are located in optimal positions depending on the mechanical structure of the catheter. This may allow for a simplified design of the handle portion. For example, by using LEDs for illumination, the termination at the handle portion may be based solely on electrical welding or wire crimping. For example, the handle portion may include a proximal plate at which the camera cable, the LED cable, and the EM sensor cable terminate, with the proximal plate being connected to an interface of the handle portion and establishing an electrical connection with the instrument drive mechanism. As described above, the instrument drive mechanism is attached to the robotic arm (robotic support system) and provides a mechanical and electrical interface for the handle portion. This may advantageously improve assembly and implementation efficiency and simplify manufacturing processes and costs. In some cases, the handle portion along with the catheter may be disposed of after a single use.

In some embodiments, the steerable catheter assembly may have a substantially integrated design, and one or more components may be integrated into the catheter, thereby simplifying the assembly, manufacturing process, while maintaining the kinematic, dynamic properties of the steerable catheter. As shown in the example, the steerable catheter assembly may include an elongate member 213 or probe portion that is proximal to the tissue and/or region to be examined. In some cases, the elongated member 213 may also be referred to as a catheter. Catheter 213 may include internal structure such as a working channel that allows insertion of a tool therethrough. By way of example, the working channel may have dimensions such as about 2mm diameter to be compatible with the mastering tool. The working channel may have any other suitable dimensions depending on the application.

The conduit 213 may be composed of a suitable material to achieve a desired flexibility or bending stiffness. In some cases, the material of the catheter may be selected such that it can maintain structural support to the internal structure (e.g., working channel) and is substantially flexible (e.g., capable of bending in various directions and orientations). For example, the catheter may be made of any suitable material, such as polyurethane, vinyl (e.g., polyvinyl chloride), nylon (e.g., vestamid, grillamid), pellethane, polyethylene, polypropylene, polycarbonate, polyester, silicone elastomer, acetate, and the like. In some cases, the material may be a polymeric material, a biocompatible polymeric material, and the catheter may be flexible enough to be advanced through a path having a small curvature without causing pain to the subject. In some cases, the catheter may include a sheath. The length of the sheath may be different from the length of the catheter. The sheath may be shorter than the catheter to provide the desired support. Alternatively, the conduit may be a substantially one-piece component.

In some cases, the distal portion or tip of the catheter may be substantially flexible such that it may be maneuvered in one or more directions (e.g., pitch, yaw). In some embodiments, the catheter may have a variable bending stiffness along the longitudinal axis. For example, the catheter may include multiple segments with different bending stiffness (e.g., flexible, semi-rigid, and rigid). The bending stiffness may be varied by selecting materials with different stiffness/rigidity, changing the structure in different segments, adding additional support members or any combination of the above. In some cases, the proximal end of the catheter need not be bent to a high degree, so that additional mechanical structures (e.g., additional layers of material) may be used to stiffen the proximal portion of the catheter to achieve greater bending stiffness. This design may provide support and stability to the catheter. In some cases, variable bending stiffness may be achieved by using different materials during catheter extrusion. This may be advantageous to allow for different levels of stiffness along the shaft of the catheter during extrusion manufacturing without additional fastening or assembling of different materials.

The distal portion of the catheter may be maneuvered by one or more pull wires. The distal portion of the catheter may be made of any suitable material, such as a copolymer, polymer, metal or alloy, so that it may be bent by a pull wire. In some embodiments, the proximal end or proximal portion of one or more pull wires may be operably coupled to various mechanisms (e.g., gears, pulleys, etc.) in the handle portion of the catheter assembly. The pull wire may be a metal wire, a metal cable or a metal wire, or it may be a polymer wire, a polymer cable or a polymer wire. The pull wire may also be made of natural or organic materials or fibers. The pull wire may be any type of suitable wire, cable or filament that is capable of supporting various loads without deforming, significantly deforming or breaking. The distal end or distal portion of one or more pull wires may be anchored or integrated to the distal portion of the catheter such that manipulation of the pull wires by the control unit may apply a force or tension to the distal portion that may at least manipulate or articulate (e.g., up, down, pitch, yaw, or any direction therebetween) the distal portion (e.g., flexible section) of the catheter.

As described above, the pull wire may be made of any suitable material, such as stainless steel (e.g., SS 316), metal, alloy, polymer, nylon, or biocompatible material. The pull wire may be a wire, cable or filament. In some embodiments, different wires may be made of different materials to change the load carrying capacity of the wires. In some embodiments, different sections of the pull wire may be made of different materials to vary the stiffness and/or load bearing along the pull wire. In some embodiments, the pull wire may be used for transmission of electrical signals.

The dimensions of the catheter may enable one or more electronic components to 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 2mm, such that one or more electronic components may be embedded into the wall of the catheter or the gap of the catheter. However, it should be noted that the outer diameter may be in any range less than 4mm or greater than 4.4mm based on different applications, and the diameter of the working channel may be in any range depending on the tool size or particular application.

The 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 camera. The imaging device may include an optical element and an image sensor for capturing image data. The image sensor may be configured to generate image data in response to a wavelength of the light. Various image sensors may be employed to capture image data, such as Complementary Metal Oxide Semiconductor (CMOS) or Charge Coupled Devices (CCDs). The imaging device may be a low cost camera. In some cases, 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 components for processing the image signals. For example, a circuit for a CCD sensor may include an a/D converter and an amplifier to amplify and convert an analog signal provided by the CCD sensor. Optionally, the image sensor may be integrated with an amplifier and a converter to convert analog signals to digital signals, so that a circuit board may not be required. In some cases, the output of the image sensor or circuit board may be image data (digital signals) that may be further processed by the camera circuitry or processor of the camera. In some cases, the image sensor may include an array of optical sensors.

The illumination device may include one or more light sources 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. In some cases, the light source may be a miniaturized LED or a two-tone flash LED illumination for compact designs.

In some embodiments, the catheter may be designed to be flexible. One or more sections may bend or flex as the flexible portion of the catheter is endoscopically inserted into the patient by the extension mechanism. The present disclosure provides an anti-buckling mechanism 201, which anti-buckling mechanism 201 may be coupled to a handle portion of a robotic endoscope to support a catheter.

The present disclosure provides an improved buckling restrained mechanism. The buckling preventing mechanism is used for preventing buckling of the insertion shaft. The anti-buckling mechanism 201 may be a telescoping extension device with an internal mechanism to achieve buckling prevention of the catheter during insertion and extraction. The anti-buckling mechanism 201 may be detachably connected at one end to a handle portion of the robotic endoscope and may be detachably connected at the other end to the support surface 203. The anti-buckling mechanism may include a distal plate at a distal end that is attached to a fixation device that is secured to the patient's bed by a tube clamp attachment. The fixation device may be a post fastened to the bed, in which case no additional force is applied to the patient when the buckling prevention device collapses. In other embodiments, the securing device may be a rail on a bed.

As shown by way of example, the anti-buckling tube may be attached to a bracket on the instrument drive mechanism and may be removable and disposable via a quick release mechanism after the procedure. The support arm may be supported by a robot-movable cart that supports the endotracheal tube and provides a support surface for the distal end of the buckling prevention tube to press against when it is compressed. The support arm may be controlled to rotate, translate vertically up and down, and/or may be a boom arm that expands and contracts so that it may be positioned precisely over the patient's mouth and attached to the endotracheal tube rack. The positioning of the support arm may be synchronized with the movement of the robotic arm so that it can track the position of the catheter entry point. Fig. 3 shows an example of an assembly of an anti-buckling mechanism 301 and a handle 303. These examples illustrate the anti-buckling mechanism connected to the handle and in a retracted/collapsed state and a fully extended state.

In some cases, the systems and devices herein may allow for simplified setup procedures for assembling the anti-buckling mechanisms and the endoscope. For example, the anti-buckling mechanism and the scope handle may be assembled via a lateral connection between the anti-buckling mechanism and the scope handle, and the assembly is top-loaded onto the instrument drive mechanism as a single piece. This convenient assembly capability advantageously allows coupling of the scope handle and the anti-buckling assembly to the robotic arm, regardless of the state and current position of the instrument drive mechanism. Fig. 4 shows an example of an inspection scope handle and anti-buckling tube assembly. The buckling prevention device may be releasably connected to the handle via a connection feature. This allows the user to place the connection assembly of the anti-buckling device 401 and the scope onto the instrument drive mechanism 405 via the interface of the handle 403. Assembling the inspection scope and the anti-buckling mechanism prior to loading it onto the instrument drive mechanism may advantageously simplify the workflow. Fig. 5 and 6 show an assembled example of the buckling restrained device 501 and the inspection scope (catheter assembly) 503. In some cases, the buckling restrained device may be a detachable device that is disposable after a single use. Alternatively, the buckling restrained device may be reusable or adapted for multiple uses.

The anti-buckling mechanism may comprise a plurality of telescoping segments connected in sequence. Fig. 7 illustrates an example of multiple telescoping segments of an anti-buckling mechanism according to some embodiments of the present invention.

In some embodiments, the buckling restrained device may include a plurality of modular segments 701, 703 of progressively decreasing size (e.g., diameter of the modular segments). Modular segments may also be referred to as telescoping segments, which are used interchangeably throughout the specification. The plurality of modular segments may be assembled or connected concentrically along the axial axis.

In some embodiments, each modular segment may include a cap and a tube. The cap may include internal features, such as support features, to prevent buckling of the catheter 705. During use, the catheter or elongate member 705 may be placed within the buckling restrained device. As the handle portion or instrument drive device is advanced distally, the plurality of modular segments may retract relative to one another to form a shortened configuration. As the handle portion or instrument drive device is moved proximally, the plurality of modular segments extend out of their respective adjacent tubes to form an elongated configuration.

The catheter (elongate member) is disposed within a lumen formed by the tubes together and is prevented from buckling by the support features of the cap. The elongate member may be supported by the support features of the cap of each modular segment. The small bending of the elongate member will bring the elongate member into contact with the caps (e.g., the support features of the caps) of the respective modular segments, effectively preventing any buckling over the entire length of the elongate member. This advantageously prevents buckling of the elongate member in any direction and any position along the length inside the buckling prevention device, regardless of the outer dimensions of the plurality of modular segments.

In some embodiments, a tube with coupling features may be formed to facilitate coupling with another tube without the need for additional coupling means (e.g., glue, fasteners, etc.). This may advantageously allow easy replacement of a modular segment or replacement of the modular segment with a new/different segment. The quick coupling and release feature may also allow for an adjustable anti-buckling device by adding/removing one or more modular segments from the distal and/or proximal ends.

Fig. 8 and 9 illustrate an example of a modular segment 801. Fig. 9 shows a cross-sectional view of a module segment. Modular segment 801 may include a tube component 803 and a cap component 805. The tube member and the cap member may be releasably coupled together to form a modular segment, such as via a coupling feature. The coupling features may be integrally formed on the tube component and/or the cap component, such that additional coupling means may not be required. In some cases, the coupling feature may include a snap feature. The cap may be connected to the tube without the need for additional tools or coupling means. For example, the cap may snap onto the tube at one end of the tube. In some cases, the cap may be assembled to the tube at the proximal end. Alternatively, the cap may be assembled distally to the tube.

The assembled modular segment may be releasably coupled to another modular segment via a coupling structure. Fig. 10 shows an example of a pipe member 1000. The tube member may have a cross-section of any suitable shape (e.g., circular, rectangular, etc.). In the illustrated example, the tube member 1000 may be a substantially cylindrical body composed of thin walls. In some cases, the inner surface of the tube may have a draft angle for injection molding. The draft angle also helps prevent sagging of the modular segments when extended. Alternatively, the inner surface of the tube may not have a draft angle. The tube may be manufactured using any suitable manufacturing method, such as injection molding, CNC machining, blow molding, 3D printing, and various other methods.

The tube may include a coupling structure to engage the tube with a tube of another modular segment. In some cases, the coupling structure may include an inner stop lip feature 1005 at a first end of the tube and an outer stop lip feature 1001 at an opposite end of the tube. The external stop lip feature (e.g., a radial protrusion slightly larger than the outer diameter of the cylinder) may prevent the respective modular segment from disengaging from an adjacent external modular segment. The internal retaining lip feature may prevent adjacent internal modular segments from disengaging from respective modular segments. In some cases, the inner stop lip feature 1005 and the outer stop lip feature 1001 may be integrally formed with the tube.

The inner and outer stop lip features may prevent the tube/modular segment from separating during extension of the anti-buckling device. For example, the tubes of adjacent outer modular segments 1010 may engage the tubes of modular segments 1000 via the inner stop lip features 1011 of the outer tubes and the outer stop lip features 1001 of the inner tubes.

As described above, the tube 1000 may also include snap features 1003 for engagement with the cap. Fig. 11 shows another view of the tube. The snap feature 1003 may allow the tube to be assembled with the cap without any additional coupling means (e.g., adhesive or fasteners).

The tube member may be formed of any suitable material. For example, the tube may be composed of a plastic material to form the snap features at reduced cost. Suitable materials may be nonmetallic materials including, but not limited to, polycarbonate, acrylonitrile butadiene styrene, polypropylene, polyurethane (Pebax ^TM ) Nylon, polyethylene, delrin ^TM Polyester, kevlar ^TM Carbon, ceramic, silicone, kapton ^TM Polyimide, teflon ^TM Coating, polytetrafluoroethylene (PTFE), plastic (non-porous or porous), latex, polymer, or metallic materials. In some cases, the material of the modular segments may be selected to reduce friction between adjacent tubes.

Fig. 12A shows an example of a cap member 1200. The cap member includes a support feature to support the catheter during delivery to the patient. The cap member may also act as a stop to prevent the inner modular segment from exiting the proximal end of the outer modular segment (as shown in fig. 13). The cap member 1200 may have an outer dimension/geometry that matches the dimension/geometry of the outer surface of the tube. The outer dimensions/geometry of the cap member may vary depending on the dimensions/geometry of the corresponding tube. The cap member may include a cutout 1203 to engage a snap-fit engagement on the tube member for assembly as shown in fig. 12B. This advantageously allows easy coupling or release of the cap from the tube and replacement of the cap/tube without additional tools. In some cases, the cap members may be engaged with respective tube members at the proximal end. Alternatively, the cap members may engage with respective tube members at the distal end.

In some embodiments, the cap member may include support features 1201 for providing support to the catheter and preventing bending/buckling thereof. In some cases, the support features may have a generally pyramidal structure. In some cases, the support feature 1201 may have a first opening 1205 (bottom opening of the vertebral body structure) that is slightly larger in diameter than the catheter/sheath. In some cases, the size of the first opening may be selected based on allowable catheter deflection, catheter diameter, and/or tolerances. For example, the first opening may have a larger diameter when allowing for greater catheter deflection.

The diameter of the first opening of the cap of all modular segments may be the same such that movement of the catheter may be limited relative to the buckling prevention device at any location along the length in the cross-sectional plane. The first opening 1205 in the center of the cap may allow the catheter to slide smoothly along the drive axis and may provide normal compression to prevent bending or buckling of the catheter as the telescoping tube extends. The support feature may have a second opening 1207 (the top opening of the cone structure). In some cases, the second opening 1207 may also provide support for the catheter. The catheter may contact any portion of the support member or tube as it bends within the buckling restrained device. In some cases, the dimensions of the second opening 1207 or the support structure may vary based on the different dimensions of the modular segments. The second opening and the support structure may also assist in aligning the plurality of coupled modular segments when they are in the collapsed state (as shown in fig. 13).

It should be noted that while the support structure is illustrated as a conical structure, the first opening of the support structure may have various shapes (e.g., rectangular cross-section) or sizes so long as it has a size/shape corresponding to the size/shape of the conduit.

Fig. 13 shows an example of coupled modular segments. Caps of multiple modular segments 1301, 1303 may collectively support the catheter and prevent it from buckling. The plurality of caps 1305 may facilitate alignment of the plurality of modular segments with one another as the plurality of modular segments/buckling prevention devices collapse. For example, the support structures of adjacent caps may be stacked and self-centering when the respective modular segments are in the collapsed state. The inner and outer retaining lip features of each tube prevent separation of the assembly when the plurality of modular segments are in the extended state.

Fig. 14-16 illustrate another example of a modular segment 1400, and the modular segment 1400 may have a generally rectangular cross-section. The modular segments may be a single piece part. One end of the modular segment may include an end surface 1405 with a notched hole 1407 to support the catheter. The end surfaces may be integrally formed with the sidewalls 1409 of the modular segments. The side wall 1409 may include a snap feature 1401 and a cut-out 1403 to allow for assembly of multiple modular segments. Fig. 15 illustrates the snap features of the inner modular segment 1501 engaged with the windows 1503 of the outer modular segment. For example, the inner modular segment may be inserted and locked from the proximal end of the outer modular segment when the snap features of the inner modular segment are engaged with the windows of the outer modular segment. This may advantageously allow the modular segments to be assembled without additional tools or additional coupling means. Fig. 16 shows an example of coupled modular segments in a collapsed state and an extended state, respectively.

In some embodiments, the buckling restrained device may further include a locking feature to prevent accidental extension of the plurality of modular segments. The locking feature may prevent movement (e.g., translation along an axis) of the plurality of modular segments when in the collapsed state. Fig. 17-18 illustrate examples of buckling restrained devices having locking features. In some embodiments, the innermost (smallest) modular segment may have an extended surface formed with protruding structures 1703, the protruding structures 1703 engaging structures formed on the outermost modular segment of the buckling restrained device 1701. The locking feature may be part of a distal element attached to the distal end of the innermost modular segment. When the plurality of modular segments are in the collapsed state, the user may twist the locking feature in one direction to lock the anti-buckling device as shown in fig. 18 (e.g., locking state 1801) and unlock the device by rotating in the opposite direction (e.g., unlocking state 1803). Fig. 19 shows an example of other locking features. As shown, in some cases, a snap feature may be included to form engagement between the distal element and the outermost modular segment.

In another aspect, the present disclosure provides an anti-buckling device having a helical structure. The helical buckling prevention device may include an extendable and collapsible helical structure formed of a thin material. The helical buckling restrained device may provide unique advantages such as improved continuous support of the catheter, compact size, reduced weight/mass of material, and reduced manufacturing costs. Fig. 20-27 illustrate examples of helical buckling restrained devices.

Fig. 20 and 21 show an example of a helical buckling restrained device 2000 in an extended state. Fig. 22 shows the helical buckling prevention device in a collapsed state. In some embodiments, the helical buckling restrained device 2000 may include a plurality of components/structures including a connector component 2001, a helical rolling structure 2003, a tube component 2005, and a straw component 2007.

The helical rolling structure 2003 may provide support for the catheter. The spiral rolling structures 2003 may be formed from a sheet of material. The sheet of material can be rolled to a desired radius corresponding to the size of the catheter. The sheet of material may be spirally rolled such that it may be extended and retracted along the longitudinal axis. In some cases, the material may be a lightweight material such as paper, a lightweight durable material such as polyethylene fibers (e.g., tyvek), a plastic sheet (e.g., polyethylene (PE), polypropylene (PP)), a fabric, a metal sheet (e.g., aluminum), and other lightweight durable materials. The spiral rolling structure 2003 may be manufactured using any suitable manufacturing method, such as roll forming. Such spiral designs, as well as sheet materials, may advantageously provide a device having an overall compact size and reduced weight.

The dimensions or size of the helical rolling structure 2003 may be adapted to the dimensions of the catheter. The spiral rolling structure 2003 may have a substantially conical shape. Unlike telescoping structures where the catheter is supported by discrete points at each segment, the helical rolling structure has a diameter that continuously increases/decreases along the length, thereby providing continuous support for the catheter.

In some cases, the size and material of the helical rolling structure 2003 may be selected to reduce friction between the sheets and/or to optimize the bending and axial stiffness of the device. In some cases, the dimensions and materials may be selected such that the device may advantageously prevent excessive buckling under high insertion forces. For example, by selecting an appropriate material and structure that can withstand a predetermined amount of force, the rolling structure may kink and tear significantly when a certain amount of force is applied. This advantageously reduces the likelihood of injury to the patient and provides additional safety in that the buckling prevention device breaks before the endoscope system can apply excessive force to the patient. In addition, because the diameter of the proximal helical rolling structure is greater than the outer diameter of the catheter, some degree of buckling of the catheter may occur. However, such slight buckling may not affect the insertion process due to the continuous support of the catheter. By selecting the breaking point (e.g., threshold force) of the helical rolling structure as described above, such buckling is controlled within allowable levels.

The tube member 2005 is connected at a proximal end to a helical rolling structure 2003. For example, the outside of the helical rolling structure 2003 may be attached to the pipe part. The tube member 2005 may have features that allow it to be releasably coupled to a robotic endoscope (e.g., a handle portion of an endoscope).

The helical buckling prevention device may comprise a connector part 2001 at the distal end. The connector part 2001 may be attached to the bedside module during use. Fig. 23 shows a side view 2300 and a cross-sectional view 2310 of a helical buckling prevention device (in a collapsed state). The connector part 2001 may be used as a "pen cap" for a helical buckling prevention device. For example, when the helical buckling prevention device is in the collapsed state, the connector part 2001 and the tube part 2005 may be connected, such as by pushing together, so that the connector part may prevent unwanted extension. In some cases, connector component 2001 and tube component 2005 may be connected/coupled together via a friction fit. Alternatively, other connection features (e.g., locking features) may be included to releasably connect the connector component 2001 and the tube component 2005. In some cases, connector component 2001 may have ergonomic features to allow a user to grasp when extending the anti-buckling device.

In some embodiments, connector component 2001 may have a generally cylindrical shape. Connector component 2001 may have a size and geometry that aligns it against the outer diameter of tube component 2005 to provide a friction fit (when in the collapsed state) and center straw component 2007. The connector may have any other shape or size. Fig. 27 shows an example of a buckling restrained device with a different connector design, wherein its shape is not cylindrical. Fig. 28 shows a cross-sectional view of the buckling restrained device in fig. 27. The connector 2801 may also serve as a cap that may be releasably connected to the tube component 2803 or the proximal body 2809 in a collapsed state. The connector component 2001 may include a structure 2802, the structure 2802 having a size and geometry that mates with the outer diameter of the distal end of the straw component 2805. A distal portion of the straw member 2805 may also be attached to a distal portion of the helical rolling structure 2807.

A straw member 2007 may be attached to the distal end of the connector member 2001 and the helical rolling structure to join the connector member with the helical rolling structure. The pipette component 2007 may have a generally cylindrical shape with a constant diameter. The straw member 2007 may have an outer diameter that matches the smallest diameter of the helical rolling structure. In some cases, the straw component 2007 may be integrally formed with the connector component. For example, the straw member and the connector member may be formed as a single piece using injection molding or other suitable method. Alternatively, the straw member 2007 may be formed as a separate piece and assembled to the connector member and the rolling structure. For example, the straw member may be manufactured by extrusion and assembled to the connector member.

In some cases, the straw component 2007 may include self-centering features to assist in alignment. The self-centering feature may guide the alignment of the buckling prevention device as it collapses. For example, the proximal end of the straw member 2007 may have a funnel-shaped feature (e.g., a male part), and the male funnel-shaped feature may be self-centering by interfacing with a cone shape of a rolling structure or a tube member (e.g., a female part) having a larger diameter when the buckling prevention device is closed.

The straw member may be in contact with the distal end of the catheter to provide support to the distal end of the catheter. Fig. 24 shows an example of a catheter 2400 inserted into an anti-buckling device. The distal end of catheter 2300 is supported by straw member 2007. The size (e.g., diameter) of the straw member may depend on the diameter of the catheter. In some cases, the length of the straw member may be selected to provide sufficient friction with the rolling structure. The size of the rolling structure (e.g. the diameter at the distal end) may depend on the diameter of the straw member, while the diameter at the proximal end may correspond to the diameter of the tube member.

The tube member 2005 is connected at a proximal end to a helical rolling structure 2003. For example, the outer face of the helical rolling structure 2003 may be attached to the pipe member. The tube member 2005 may have features that allow it to be releasably coupled to a robotic endoscope (e.g., a handle portion of an endoscope).

As described above, the systems and devices herein may allow for simplified setup procedures for assembling the anti-buckling mechanism and the endoscope. For example, the anti-buckling mechanism and the scope handle may be assembled via a removable connection between the anti-buckling mechanism and the scope handle, and the assembly is top-loaded onto the instrument drive mechanism as a single piece. This convenient assembly capability advantageously allows coupling of the scope handle and the anti-buckling assembly to the robotic arm, regardless of the state and current position of the instrument drive mechanism. Fig. 25 and 26 illustrate examples of the assembly of the buckling prevention device 2500 and the catheter assembly 2510. In some cases, the helical buckling prevention device may be a detachable device that can be disposed of after a single use. The helical buckling prevention device may be releasably connected to the handle of the catheter assembly 2510 via a connection feature. This allows a user to place the connection assembly of the anti-buckling device and the inspection scope onto the instrument drive mechanism 2520 (e.g., the robotic main device) via the interface of the handle.

As described above, the provided helical buckling restrained device may allow for a lightweight compact with reduced costAnd (3) performing design. The spiral rolling structure may be formed from a sheet of material, which may be lightweight and durable. The tube members, connector members and straw members may be composed of plastic materials, thermoplastic polymers, such as acrylonitrile butadiene styrene, polypropylene, polyurethane (Pebax ^TM ) Nylon, polyethylene, delrin ^TM Polyester, PE, PP, and other various materials. In some cases, other non-plastic materials, such as metal, may be utilized. These components can be easily (e.g., injection molded) manufactured from injection molded plastic at reduced cost. Any suitable manufacturing method may also be employed, such as 3D printing (e.g., powder-based processes such as multi-jet fusion, gypsum-based 3D printing (PP)), CNC machining, and blow molding.

Although embodiments of the anti-buckling devices have been described with reference to a medical robotic system, it should be noted that the anti-buckling devices described herein may be used to provide anti-buckling features for any medical device having an elongated and flexible configuration. For example, in other embodiments, embodiments of the buckling restrained devices described herein may be used to support any flexible tool in the medical arts, such as endoscopes, flexible graspers, laser fibers, and the like.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Many variations, changes, 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 practicing the invention. The following claims are intended to define the scope of the invention and their equivalents and methods and structures within the scope of these claims are therefore covered thereby.

Claims (20)

1. An anti-buckling device comprising:

a plurality of modular segments, wherein each modular segment comprises a cap and a tube;

wherein the cap includes a support feature configured to support an elongated member, and wherein the tube includes a coupling feature configured to engage a given modular segment with another modular segment.

2. The buckling prevention device of claim 1, wherein the elongate member comprises a proximal end and a distal end, wherein the proximal end is detachably attached to a robotic arm via a handle, and wherein the distal end is integrated with an imaging device, a position sensor, and an illumination device.

3. The buckling prevention device of claim 2, wherein the distal end comprises a structure that receives the imaging device, the position sensor, and the illumination device.

4. The buckling restrained device of claim 2, wherein the imaging device, the position sensor and the illumination device are arranged in a compact configuration.

5. The buckling restrained device of claim 2, wherein the handle is connected to a first end of the buckling restrained device.

6. The buckling prevention device of claim 2, wherein the handle comprises an interface configured to couple the handle to an instrument drive mechanism attached to the robotic arm.

7. The buckling prevention device of claim 2, wherein the elongate member further comprises a curved section hinged by one or more pull wires.

8. The buckling restrained device of claim 1, wherein the support feature comprises a first opening having a size that matches a size of the elongated member.

9. The buckling prevention device of claim 1, wherein the support feature is configured to align a modular segment with an adjacent modular segment when the modular segment is in a collapsed state with the adjacent modular segment.

10. The buckling restrained device of claim 1, wherein the cap is releasably coupled to the tube.

11. The buckling prevention device of claim 1, further comprising a locking feature for preventing movement of the plurality of modular segments when they are in the collapsed state.

12. An anti-buckling device comprising:

a helical rolling structure formed from a sheet of material for supporting the elongate member;

a first member connected to a distal end of the helical rolling structure; and

a second member connected to the proximal end of the helical rolling structure,

wherein the first and second members are releasably connected when the buckling restrained device is in a collapsed state.

13. The buckling restrained device of claim 12, wherein the material is paper or fabric.

14. The buckling restrained device of claim 12, wherein the first member connects the buckling restrained device to a member at a patient bed.

15. The buckling restrained device of claim 12, wherein the second component connects the buckling restrained device to a handle portion of the elongated member.

16. The buckling restrained device of claim 12, wherein the helical rolling structure provides continuous support for the elongated member.

17. The buckling restrained device of claim 12, wherein the first member is connected to the distal end of the helical rolling structure via a third member.

18. The buckling restrained device of claim 17, wherein the first member is connected to the distal end of the helical rolling structure via the third member.

19. The buckling restrained device of claim 18, wherein the third component provides support for a distal end of the elongated member.

20. The buckling restrained device of claim 17, wherein the third component comprises a self-centering feature to assist in alignment when the buckling restrained device is in a collapsed state.