Barrier assembly for telescoping robot
Barrier apparatuses with expandable curtains and drapes address the challenge of debris interference and cross-contamination in medical procedures, ensuring efficient operation and reducing contamination risks for elongate medical instruments.
Patent Information
- Application Number
- PCT/US2025/044354
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-08-29
- Filing Date
- 2025-08-29
- Publication Date
- 2026-03-05
AI Technical Summary
Existing medical procedures face challenges in managing and controlling elongate, flexible medical instruments such as endoscopes, catheters, and guidewires, particularly in crowded operating rooms, and there is a need for devices that can block debris from interfering with these instruments and prevent cross-contamination.
The development of barrier apparatuses that provide coverage for mount assemblies of medical devices, including curtains and drapes that expand and contract to block debris, and are configured to cover electronic and mechanical components of positioning apparatuses, allowing for efficient operation and reducing cross-contamination.
The barrier apparatuses effectively prevent debris from contacting and entering sensitive components of medical instruments, ensuring proper functioning and reducing the risk of cross-contamination, while being designed for ease of use and cost-effectiveness.
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Figure US2025044354_05032026_PF_FP_ABST
Abstract
Description
BARRIER ASSEMBLY FOR TELESCOPING ROBOTCLAIM OF PRIORITY
[0001] This patent application claims priority to U.S. provisional patent application no. 63 / 688,867, titled “BARRIER ASSEMBLY FOR TELESCOPING ROBOT,” and filed on August 29, 2024, herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.BACKGROUND
[0003] Medical procedures such as endoscopy may involve accessing and visualizing the inside of a patient's anatomy for diagnostic and / or therapeutic purposes. For example, gastroenterology, urology, and bronchoscopy involve medical procedures that allow a physician to examine patient lumens, such as the gastrointestinal tract, urology tract, vasculature, and airways. During these procedures, flexible tools or instruments, generally referred to as flexible tubular members such as endoscopes, overtubes, catheters, or guidewires, are inserted into the patient through an orifice (e.g., a natural orifice or an incision) and advanced towards a tissue site identified for subsequent diagnosis and / or treatment. The medical instrument can be controllable and articulable to facilitate navigation through the anatomy.
[0004] Management of these devices may be particularly challenging in already crowded operating rooms. Colonoscopes are just one example of a device, in this case an endoscope, that may be long and difficult to manage, particularly for robotic systems in which advancing / retracting and / or steering may be driven by a controller such as a robotic controller. Enteroscopes are used for navigation of the small intestine, and they may be even longer in length. Similar challenges exist for catheters, which are also longer length and flexible. Vascular catheters may advance into the neurovasculature, peripheral vasculature, pulmonary vasculature, and the cardiac and coronary vasculature. Guidewires may be used in the vasculature, usually in conjunction with catheters. Overtubes may be used with endoscopes. Overtubes may be used in conjunction with endoscopes, or an endoscope may be withdrawn such that only an overtube remains.- 1 -SG Docket No.: 13668-737.600
[0005] Although a large number of elongate, flexible, insertable tools (flexible tubular members, e.g., endoscopes, catheters, overtubes, guidewires, etc.) are used, or have been suggested for use, in medical procedures, controlling the insertion and operation of such apparatuses becomes increasingly unwieldy as their length increases. Thus, there is a need for storage and dispensing methods and apparatuses that allow compact and efficient operation of elongate medical instruments including flexible tubular members such as endoscopes, catheters, overtubes and guidewires. Further, there is a need for methods and devices for providing a barrier to block debris produced during a medical procedure from contacting and / or entering certain components of the apparatuses. Such barrier could prevent debris from interfering with the functioning of the apparatuses and / or reduce potential crosscontamination.SUMMARY OF THE DISCLOSURE
[0006] Described herein are apparatuses (e.g., systems, devices, etc.) and methods for providing a barrier for blocking or covering components of medical apparatuses during medical procedures. The barrier apparatuses may address the challenges of providing a barrier for such apparatuses to block debris (e.g., bodily fluid and / or materials) from contacting and / or entering certain components of the apparatuses, which could otherwise potentially interfere with functioning of the apparatuses. In some examples, the barrier apparatuses may act as sanitary devices in that they may reduce potential cross-contamination of infectious agents.
[0007] Example medical apparatuses may include positioning apparatuses for positioning one or more flexible tubular medical devices relative to the patient. Positioning may include loading, dispensing or deploying, driving (e.g., advancing / retracting, steering, etc.), and withdrawing the one or more flexible tubular medical devices. The flexible tubular medical devices may include one or more of: endoscopes, catheters, overtubes and / or guidewires, and in particular long-length endoscopes, including colonoscopes and enteroscopes.
[0008] In general, these barrier apparatuses can provide a barrier to a mount assembly of the medical device positioning apparatuses. The mount assembly may be positioned close to the patient, and therefore may be exposed to debris (e.g., bodily material) during a medical procedure. The mount assembly may include regions that move relative to each other and / or include electronic components. For example, the mount assembly may be configured so that two mounts may move relative to each other to allow relative movement of an inner verses an outer member of a nested tubular medical device. The mount assembly may include a track for guiding an inner tube mount of the positioning apparatuses. The barrier apparatuses may - 2 -SG Docket No.: 13668-737.600be configured to provide blocking coverage of the mount assembly as the inner tube mount moves. The barrier apparatuses are also configured to cover one or more controls for controlling the positioning of the tubular medical devices relative to the patient.
[0009] In one example, a barrier apparatus for covering at least a portion of positioning apparatus for positioning an endoscope that includes a mount assembly including an overtube mount and an inner tube mount, wherein the inner tube mount is configured to translate proximally and distally relative to the overtube mount. The endoscope also includes a mount support having a side from which the overtube mount and the inner tube mount laterally extend, the side of the mount support including a track that defines a path of translation of the inner tube mount. The barrier apparatus includes a rod assembly including a rod within a tube, where the tube is configured to couple with the inner tube mount of the mount assembly, and wherein the tube is configured to slidably translate over the rod when the inner tube mount translates. The barrier apparatus also includes first and second curtains slidably coupled with the rod. The first curtain is configured to be positioned distally with respect to the inner tube mount, and the second curtain configured to be positioned distally with respect to the inner tube mount. The first and second curtains are configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris. The barrier apparatus may further include first and second drapes, wherein the first drape is configured to cover the overtube mount of the positioning apparatus, and the second drape is configured to cover the inner tube mount of the positioning apparatus. The second drape may include a pocket region including a frame that defines a perimeter for accommodating one or more interface features of the inner tube mount. The second drape may include a pocket region including a film made of two polymer sheets having different surface characteristics. The barrier apparatus may include first and second mount interface members, where the first mount interface member is configured to couple to the overtube mount over the first drape, and the second mount interface member is configured to couple to the inner tube mount over the second drape. The first mount interface member may include a rod support that is coupled with the rod, and the second mount interface member includes a tube support coupled with the tube, where the rod support and the tube support support the rod and tube at a predetermined height with respect to the overtube mount and an inner tube mount. The first mount interface member may include features configured to couple with an overtube of the endoscope, and the second mount interface member may include features configured to couple with an inner tube of the endoscope. A proximal edge of the first drape may be sealed to the first curtain, a distal edge of the second drape may be sealed to the first curtain, and a proximal edge of the second- 3 -SG Docket No.: 13668-737.600drape may be sealed to the second curtain. The rod assembly may include first and second curtain stops that are configured to push against respective first and second curtains, thereby causing the first and second curtains to laterally contract. Each of the first and second curtains may include flag portions that extend from a non-blocking side of that is opposite a blocking side of the respective first and second curtains, wherein the flag portions include holes through which the rod runs through. Each of the first and second curtains may include pleats that provide organized expansion and contraction of the first and second curtains.
[0010] For example, any of these barrier apparatuses (e.g., for covering at least a portion of positioning apparatus for positioning an endoscope) may include: a rod assembly including a rod within a tube, wherein the tube is configured to couple with the inner tube mount of the mount assembly, and wherein the tube is configured to slidably translate over the rod when the inner tube mount translates; and one or more curtains slidably coupled with the rod. The one or more curtains may be configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris.
[0011] In another example, a system for positioning an endoscope includes a positioning apparatus configured to position the endoscope. The positioning apparatus includes a mount assembly comprises an overtube mount and an inner tube mount, where the inner tube mount is configured to translate proximally and distally relative to the overtube mount. The positioning apparatus also includes a mount support having a side from which the overtube mount and the inner tube mount laterally extend. The side of the mount support includes a track that defines a path of translation of the inner tube mount. The system also includes a barrier apparatus configured to cover at least a portion of the mount assembly. The barrier apparatus includes a rod assembly including a rod within a tube, where the tube is configured to couple with the inner tube mount of the mount assembly, and where the tube is configured to slidably translate over the rod when the inner tube mount translates. The barrier apparatus also includes first and second curtains slidably coupled with the rod, the first curtain positioned distally with respect to the inner tube mount, and the second curtain positioned distally with respect to the inner tube mount. The first and second curtains are configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris.
[0012] In a further example, a method of covering a positioning apparatus for positioning an endoscope with a barrier apparatus is described. The positioning apparatus includes a mount assembly including an overtube mount and an inner tube mount, where the inner tube mount is configured to translate proximally and distally relative to the overtube mount. The - 4 -SG Docket No.: 13668-737.600positioning apparatus also includes a mount support having a side from which the overtube mount and the inner tube mount laterally extend, the side of the mount support including a track that defines a path of translation of the inner tube mount. The method includes coupling a first mount interface member and a first drape of the barrier apparatus to the overtube mount. The first drape is a first sheet of material that covers surfaces of the overtube mount. The first mount interface member is a first rigid platform configured to couple with an overtube of the endoscope. The first mount interface member includes a rod support that supports a rod above the mount support of the positioning apparatus. The method also includes coupling a second mount interface member and a second drape of the barrier apparatus to the inner tube mount. The second drape is a second sheet of material that covers surfaces of the inner tube mount. The second mount interface member is a second rigid platform configured to couple with an inner tube of the endoscope. The second mount interface member includes a tube support that supports a tube above the mount support of the positioning apparatus. The tube has the rod positioned therein such that the tube can slidably translate over the rod when the inner tube mount translates. A first curtain is slidably coupled with the rod at a position distal to the second mount interface member. A second curtain is slidably coupled with the rod at a position proximal to the second mount interface member. The first and second curtains are configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris.
[0013] Any of the barrier apparatuses, or portions of the barrier devices, may include components that are single use (‘disposable’), multiple or multi-use (‘resposable’), sheathed, or a very large number of uses (‘reusable’). These elements may be engineered to reduce cost and landfill. They may be engineered for lower effective per-case cost. They may be engineered for ease of use, ease of installation, fast procedure set-up, and ease of removal. For example, in some cases, the curtains of the barrier apparatuses may be reusable (e.g., configured for removal and cleaning). In some cases, the entire barrier device may be disposable.
[0014] The positioning apparatus described herein may include a telescoping link assembly that includes adjacent links slidably coupled together. The links may be configured to extend from a compact configuration, wherein the mount assembly is on a most distally extending link. A linear driver of the positioning apparatus may be configured to drive relative movement of the links. The mount assembly may include one or more drivers (e.g., separate from the driver for the links) for steering and / or otherwise manipulating the flexible- 5 -SG Docket No.: 13668-737.600tubular medical device. Any appropriate drive(s) (e.g., drive sub-systems, drivers, etc.) may be used to drive movement of the mount(s) and / or the link assembly.
[0015] Also described herein are nested apparatuses including a fluid barrier that may be used with a medical robot (e.g., a telescoping robot) including any of these described herein. For example an apparatus may include: a first base configured to couple to a medical robot; a first tubular member extending from the first base, wherein the first tubular member is flexible; a second base configured to couple to the medical robot; a second tubular member extending from the first base, wherein the second tubular member is steerable and inserted through the first base and the first tubular member; a first barrier tube, wherein the first barrier tube extends over the second tubular member between the first base and the second base, further wherein the first barrier tube is configured to change length as a spacing between the first base and the second base is changed.
[0016] In any of these apparatuses, the first tubular member may comprise an overtube. The first tubular member may be configured to rigidize. The second tubular member may comprise an endoscope or an endoscope shield. For example the second tubular member may be configured to rigidize.
[0017] In any of the apparatuses described herein the barrier (e.g., first and / or second barrier tube) may be formed of a fluid-impermeable material and / or of an absorbent material.
[0018] Any of these apparatuses may include a second barrier tube extending from the second base over the first tubular member. The second barrier tube may extend only partially over a length of the first tubular member. The first barrier tube may comprise an accordion pleating. The first base and the second base may be releasably coupled together with the first barrier tube compressed between them in an initial configuration.
[0019] For example, a nested apparatus may include a fluid barrier, the apparatus comprising: a first base configured to couple to a medical robot; a first tubular member extending from the first base, wherein the first tubular member is flexible; a second base adjacent to the first base and configured to couple to the medical robot; a second tubular member extending from the first base, wherein the second tubular member is steerable and inserted through the first base and the first tubular member; a first barrier tube formed of a fluid-impermeable material, wherein the first barrier tube extends over the second tubular member between the first base and the second base, further wherein the first barrier tube is configured to change length as a spacing between the first base and the second base is changed.
[0020] All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.- 6 -SG Docket No.: 13668-737.600BRIEF DESCRIPTION OF THE DRAWINGS
[0021] A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments.
[0022] FIGS. 1 A and IB illustrate an example of a robotic positioning apparatus for positioning a flexible tubular member.
[0023] FIGS. 2 A and 2B illustrate an example of an elongate medical instrument, such as a nested scope device, that may be used with the methods and apparatuses described herein. The elongate medical instrument in this example is an endoscope (e.g., in some examples, a colonoscope) having a nested inner member and an outer member that are both selectively rigidizing.
[0024] FIGS. 3A-3C illustrate an example of a vertically arranged link assembly, for example, as part of the positioning apparatus of FIGS. 1 A and IB for positioning a flexible tubular member, such as the scope device of FIGS. 2 A and 2B.
[0025] FIGS. 4A-4C illustrate an example of a flexible tubular member positioning system being used to perform lower and upper GI procedures.
[0026] FIGS. 5A-5D illustrate an example of a barrier assembly for covering a positioning apparatus for positioning a flexible tubular member.
[0027] FIGS. 6A-6I illustrate an example production of curtains for barrier apparatuses described herein.
[0028] FIGS. 7A-7F illustrate an example production of an example second drape for the barrier apparatuses described herein, and examples of coupling the second drape with other components of the barrier apparatus.
[0029] FIGS. 8A-8G illustrate an example formation and incorporating a pocket region into the second drape of FIGS. 7A-7F.
[0030] FIGS. 9A-9K illustrate examples of coupling the second drape of FIGS. 7A-7F to other components of the barrier apparatus.
[0031] FIGS. 10A-10G illustrate an example production of an example first drape for the barrier apparatuses described herein, and examples of coupling the first drape with other components of the barrier apparatus.
[0032] FIGS. 11 A-l 1H illustrate examples of coupling the first drape of FIGS. 10A-10G to other components of the barrier apparatus.
[0033] FIGS. 12A-12C illustrate an example of a nested apparatus including a fluid barrier. The nested apparatus is configured to be used with a medical robot.- 7 -SG Docket No.: 13668-737.600
[0034] FIGS. 13A-31B show an example of a nested apparatus including a fluid barrier mounted to a robot.DETAILED DESCRIPTION
[0035] Described herein are barrier apparatuses (e.g., systems, devices, assemblies, etc.) for robotic medical devices, particularly those for positioning elongate, flexible, insertable tools (flexible tubular members, e.g., endoscopes, catheters, overtubes, guidewires, etc.). The barrier apparatuses may be separate apparatuses that are configured to couple with and / or cover at least a portion of a robotic system or may be an integral part of the robotic medical system.
[0036] Aspects of the present disclosure may be used with or integrated into a robotically enabled medical system capable of performing a variety of medical procedures, including both minimally invasive procedures - such as laparoscopy - and non-invasive procedures - such as endoscopy. Among endoscopy procedures, the robotic system may be capable of performing colonoscopy, enteroscopy, bronchoscopy, ureteroscopy and / or gastroscopy.
[0037] FIGS. 1 A and IB show an example of an apparatus (e.g., system) for dispensing and / or controlling a flexible tubular member. In many of the figures described herein, including in FIGS. 1 A and IB, the apparatus is shown to be configured for use with a flexible tubular member configured as a nested endoscope that includes an outer tube (also referred to as an overtube) and an inner tube (also referred to as an inner tube) that may be moved proximally / distally relative to each other and may each be rigidized to guide and / or steer the device through the patient’s body (as described above). However, it should be understood that these apparatuses may be used with any flexible tubular member, including those that are not nested and that do not rigidize (e.g., single-body endoscopes).
[0038] In FIGS. 1 A and IB, the system 100 shown includes a base 141 that may support the weight of the rest of the system, including any flexible tubular member attached to the system. The base 141 may be weighted so as to allow the telescoping link assembly and any attached flexible tubular member to cantilever distally or proximally away from the base, while remaining stable. The base 141 may house one or more additional components, including power source, power conditioners, motors, pressure source / pressure supplies, controllers, control circuitry, etc. The base 141 may include wheels 151 to allow the apparatus to be moved and positioned relative to a patient’s bed. In some examples the base 141 may include an anchoring region 153 that may be lowered and / or raised to allow or prevent movement. The wheels 151 may be locking or lockable.- 8 -SG Docket No.: 13668-737.600
[0039] The system 100 includes a link assembly 101 configured as a vertically arranged link assembly including three links: a first link 105 (e.g., outer link), a second link 107 (e.g., an intermediate link) and a third link 109 (e.g., inner link). The first link 105 is coupled with yaw adjust arm 137 that is also configured as (or may be coupled to) a vertical lift arm 135 connecting the link assembly 101 to the baes 141. The system 100 shown includes a mount assembly that includes a pair of mounts 123, 133 that are coupled with the third link 109. In this example the first mount 123 is configured as an overtube mount for coupling with an overtube of an endoscope. The overtube mount is located at or near the distal end region of the third link and includes an overtube drive assembly (e.g., driver) 121 that may interface with the overtube of the endoscope. In some examples, the overtube drive assembly may include drive components for controlling roll, for steering (optionally, in examples in which the overtube may be steered at the distal end), and / or pressure inputs / outputs for rigidizing / de-rigidizing. The overtube mount 123 may be configured to secure to the overtube portion separately from the inner tube. In some examples the overtube mount 123 may secure by including a securing mechanism such as a clamp, clasp, latch, lock, etc.
[0040] The second mount 133 is configured as an inner tube mount and may also include an inner tube drive assembly (driver) 131. The inner tube drive assembly 131 may interface with the inner tube member and may include drive components, including steering components (e.g., for steering a distal end / tip region of a flexible tube member), roll control, pressure input / output (e.g., for rigidizing / de-rigidizing, etc.). The inner tube mount 131 may be configured to secure to the inner tube separately from the overtube, e.g., by including a securing mechanism such as a clamp, clasp, latch, lock, hook, bracket, grip, vice, etc.
[0041] In general, these apparatuses may include multiple (e.g., eight or more) degrees of freedom for the mount assembly and therefore the medical device (e.g., flexible tubular member). For example, the first 105, second 107 and third 109 links may be moved in a proximal to distal direction when extending and retracting. Insertion and retraction may be driven by an overtube insertion motor 115 (e.g., a linear drive, such as a ball screw / nut assembly). The overtube mount 123 also includes an overtube roll motor. The inner tube mount 133 includes an endoscope driver 131 including an endoscope roll motor and multiple steering motors. The link assembly is pivotally attached to a yaw adjustment arm 157 and a vertical lift arm 155.
[0042] The robotic apparatuses described herein may be configured to deliver elongate medical instruments, such as endoscopes. FIGS. 2 A and 2B show an example of a nested scope device, that may be used with the methods and apparatuses described herein. The- 9 -SG Docket No.: 13668-737.600elongate medical instrument in this example is an endoscope, for example, a colonoscope. The having a nested inner member and an outer member that are both selectively rigidizing.
[0043] In the example of FIGS. 2A and 2B, the endoscope 200 is a dual rigidizing endoscope configured as a nested system including a rigidizable (e.g., rigidizing) outer member 212 and a rigidizable inner member 210. In FIG. 2A, the steerable inner rigidizing member 210 is positioned within the outer rigidizing member 212 such that the distal end of the inner rigidizing member 210 extends outside of the outer rigidizing member. In some cases the inner rigidizing member 210 may be fully retracted into the outer rigidizing member 212. FIG. 2B shows the distal end of the inner rigidizing member 212 is bent in a desired direction / orientation and shape (e.g., via steering cables or other steering mechanism) and then rigidized (e.g., using positive or negative pressure). This and other desired shapes of the endoscope 200 may be attained by progressively bending the inner rigidizing member 212 and advancing the outer rigidizing member 212 over the inner rigidizing member 212. In some examples, this is accomplished by applying and removing positive and / or negative pressure to a wall of the rigidizing member or within the wall of the rigidizing member, and by allowing the steering cables to go slack such that the tip of the endoscope can move and be advanced and directed / oriented / steered as desired.
[0044] Examples of rigidizing medical devices and aspects related to such rigidizing devices, are described in PCT application PCT / US2023 / 064999, published as WO 2023 / 183952, filed March 27, 2023, and titled “METHODS AND APPARATUSES FOR NAVIGATING USING A PAIR OF RIGIDIZING DEVICES;” U.S. patent application no. 17 / 902,770, published as US 2023 / 0001134, filed on September 8, 2022, and titled “NESTED RIGIDIZING DEVICES;” U.S. patent application no. 18 / 000,062, published as US 2023 / 0210351, filed on May 26, 2021, and titled “RIGIDIZING DEVICES;” patent application no. PCT / US2022 / 014497, published as WO 2022 / 165302, filed on January 31, 2022, and titled, “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES;” patent application no.PCT / US2022 / 082300, published as WO 2023 / 122767, filed on December 22, 2022, and titled “METHODS AND APPARATUSES FOR REDUCING CURVATURE OF A COLON;” and patent application no. PCT / US2023 / 062206, published as WO 2023 / 154743, filed on February 8, 2023, and titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES.” Each of these patent publications are herein incorporated by reference in their entirety.
[0045] In some examples, the mount assembly for the flexible tubular member may include one or more separated drives for driving relative movement of an outer (e.g.,- 10 -SG Docket No.: 13668-737.600overtube) and inner (e.g., inner tube) member of the flexible tubular member. FIGS. 3 A-3C illustrate one example of a vertically arranged link assembly 301, for example, as part of the positioning apparatus of FIGS. 1A and IB for positioning the rigidizing scope device of FIGS. 2A and 2B. In this example, the vertically arranged link assembly 301 includes a first link 305 (e.g., outer link), a second link 307 (e.g., middle link) and a third link 309 (e.g., inner link) that are vertically arranged relative to each other and are separated by shuttles (e.g., first shuttle 319 and second shuttle 318), that may be coupled with one or more bands and / or belts to permit them to coordinate extending and retracting. The first link 305 may be coupled with a base (directly or indirectly) of the positioning apparatus, and the third link 309 may be coupled with a mount assembly (including one or more mounts).
[0046] The link assembly 301 includes a mount assembly including a first mount 323 (e.g., overtube mount) and a separately actuating second mount 333 (e.g., inner tube mount). The link assembly 301 supports the mounts 323, 333; thus, the link assembly 301 can be considered a mount support. In this example, the mounts 323, 333 extend (e.g., laterally) from a side 390 of the mount support (e.g., link 301 assembly). The side 390 may correspond to an inner-facing side or surface of the mount support (e.g., link 301 assembly) when positioning the tubular medical device with respect to a patient.
[0047] The mounts 323, 333 of the mount assembly are configured to operate together, to provide relative motion between the first and second mounts. The mounts may be directly or indirectly coupled together. For example, in FIG. 3A-3C both the first mount 323 and the second mount 333 forming the mount assembly are coupled with the third link 309 (e.g., inner link). The first mount 323, e.g., for the overtube, may be rigidly (e.g., fixedly) coupled with the third link 309. The first mount 323 may include an overtube driver (e.g., overtube roll motor 326) to drive roll of the overtube in the clockwise and / or counterclockwise direction. The second mount 333 (e.g., for the inner tube) is proximal to the first mount 323 and is configured to moved distally / proximally along an endoscope inserting track 369. In some examples, the track 369 includes a slot within the side 390 of the third link 309. In some examples, the track 369 includes a bracket (e.g., that is part of, or coupled to) the side 390 of the link 309. The second mount 333 may include one or more drivers for operating various aspects of the medical device, e.g., an inner tube roll motor 335 and / or inner tube steering motors 337. In some examples the third link 309 may include a drive for driving the second mount 333. For example, in FIG. 3 A the second mount 333 is shown fully distally relative to the first mount 323; and in FIG. 3B the second mount 333 is shown fully proximally relative to the first mount 323.- 11 -SG Docket No.: 13668-737.600
[0048] FIGS. 3A and 3B show the link assembly 301 in a retracted configuration, where the links 305, 307 and 309 are laterally aligned with each other. FIG. 3C shows the link assembly 301 in an intermediate configuration, where the links 305, 307 and 309 have been positioned such that they are laterally offset with respect to each other. In FIG. 3C, the second and third links 307, 309 are shown as partially transparent. In general, the motion of the telescoping assembly 301may be achieved with a single drive (e.g. single motor) in any of these examples. The motion of the links 305, 307, 309 may be coordinated using bands and / or synchronization belt(s). For example, the bands (and / or belts) may be steel bands.
[0049] Any of the apparatuses described herein may have link assemblies including any number of links, e.g., two links, three links, four links, five links, six links, or more. The additional links may be configured and controlled as described herein.
[0050] As mentioned, these apparatuses may be used with a variety of procedures. For example, these systems may be used as part of lower or upper gastrointestinal (GI) procedures, as shown in the top views of FIGS. 4A-4C. In these examples, a system 400, including a vertically arranged linear link assembly 401, may be used with a patient 481 in virtually any orientation on the bed / cart 482. The flexible tubular member is part of a system 400 and can be inserted and manipulated using a vertically arranged linear link assembly described herein. A position of the system 400 may be adjusted so that the flexible tubular member held by the link assembly may be used to insert, manipulate and retract the flexible tubular member into the patient’s body.
[0051] FIG. 4A shows an example colonoscopy procedure with the system 400 positioned on the foot of the patient’s bed / cart 482. FIG. 4B shows a colonoscopy procedure in which the angle of approach is adjusted. In the example of FIG. 4B, the system 400 is positioned at a side of the bed / cart 482. FIG. 4C shows the system 400 used as part of an upper GI procedure. In the example of FIG. 4C, the system 400 is positioned at a side of the bed / cart 482.
[0052] The medical device positioning apparatuses described herein may include, or be at least partially covered by, a barrier apparatus. The barrier apparatus can be configured to block or cover at least a mount of the positioning apparatus that is configured to interface with portions of the medical device (e.g., endoscope). The mount may be exposed to debris (e.g., bodily fluids and / or materials) during medical procedures (e.g., lower or upper GI procedure). The barrier apparatus blocks such debris from contacting and / or entering certain components of the positioning apparatus that could potentially prevent proper functioning and / or damage the positioning apparatus. For example, the positioning apparatus may include electrical and mechanical components, such as wires, connectors, rack gear, groves, tracks,- 12 -SG Docket No.: 13668-737.600split lines, and other electrical or mechanical components, that could potentially malfunction or become damaged when exposed to material (e.g., fluid or solid debris). In some cases, the barrier apparatus may cover surfaces of the positioning apparatus in a way that reduces the probability of cross-contamination, e.g., among patients and / or clinicians.
[0053] The barrier apparatus may include an assembly of components that are specifically configured to cover of block various portions of the delivery apparatus, and which are configured to allow functioning (e.g., movement) of the positioning apparatus.
[0054] FIGS. 5A-5D show an example of a barrier apparatus 500 for robotic positioning apparatuses described herein. FIG. 5A shows the barrier apparatus 500; and FIGS. 5B, 5C and 5D show the barrier apparatus 500 positioned on a robotic positioning apparatus.
[0055] Referring to FIG. 5A, the barrier apparatus 500 includes a rod assembly, which includes a rod 501 and a tube 503. The rod 501 may be slidably coupled with the tube 503. For example, the tube 503 may be slidably translatable over the rod 501. In some cases, the rod 501 may be configured to extend in either direction of the tube 503. A first curtain 505 is coupled with a first side of the rod 501, and a second curtain 507 is coupled with a second side of the rod 501. Each of the first and second curtains 505, 507 includes a series of holes that are linearly arranged to accept the rod 501. The holes may allow the first and second curtains 505, 507 to move along the rod 501 so that their pleats can compress (e.g., fold) and expand (unfold). The holes may allow the curtains 505, 507 to be removed from rod 501, e.g., so that they may be cleaned or disposed after use. The holes may also be arranged on flag portions that extend from a non-blocking side of the curtains 505, 507, which allows a blocking side of the curtains 505, 507 to be free of the holes. This can provide a better barrier and provide smooth movement of the curtains 505, 507. Aspects related to flag portions are described later herein (e.g., in relation to FIGS. 6A-6I).
[0056] The barrier apparatus 500 can include a first mount interface member 513 and a second mount interface member 515. The first and second mount interface members 513, 515 may each include, or correspond to, a rigid platform that is configured to couple with different portions of the tubular medical device. The first mount interface member 513 can be configured to attach removably to a first mount of the positioning apparatus, and the second mount interface member 515 can be configured to removably attach to a second mount of the positioning apparatus. The first mount interface member 513 includes a rod support 536 that is coupled with the rod 501, and the second mount interface member 515 includes a tube support 538 that is coupled with the tube 503. The rod support 536 and tube support 538 support the rod 501 and tube 503 at a predetermined height with respect to the first (e.g.,- 13 -SG Docket No.: 13668-737.600overtube) and second (e.g., inner tube) mounts. The rod support 536 and the tube support 538 also align the rod 501 and tube 503 such that tube 503 can slide over the rod 501.
[0057] The first and second curtains 505, 507 can be pleated, with the pleats arranged to allow lateral expansion of the first and second curtains 505, 507 as the rod 501 extends from either side of the tube 503. For example, the pleats may include sheets of material that are joined together vertically along edges of the sheets. The curtains 505, 507 can bend along the vertically arranged joints in an accordion-like manner when the rod 501 is extended from either side of the tube 503. That is, the curtains 505, 507 can fold along the joints so that the pleats move closer together when the rod 501 is extended. Likewise, the curtains 505, 507 can unfold along the joints so that the pleats move farther apart from each other when the first rods 501 is retracted. This allows for organized extension and contraction of the curtains 505, 507.
[0058] The barrier apparatus 500 can also include a first drape 509 and a second drape 511 that are coupled with the first and second curtains 505, 507. The first and second drapes 509, 511 are joined to the curtains 505, 507 such that they are positioned to cover respective first and second mounts of the positioning apparatus. A pocket region 517 (which may also be referred to as a pocket, bag, sack or pouch) of the second drape 511 is a framed region that defines a perimeter for accommodating one or more interface features of the second mount 555. The interface feature(s) may be configured to interface with (e.g., secure, clamp, attach) a corresponding feature of the medical device. For example, the interface feature(s) may include one or more clamps that is / are configured to clamp at least partially around a tubular portion (e.g., inner tube) of the medical device.
[0059] As discussed, the first and second curtains 505, 507 may contract and expand in an accordion fashion. Curtain stops 519 and 521 (which may also be referred to as washers or slidable members) are positioned along the rod 501 and / or tube 503 to support proximal and distal ends, respectively, of the first and second curtains 505, 507 as they contract and expand. In some examples, the stops 519 and 521 are positioned at the ends of the tube 503 to provide support where the rod 501 enters the tube 503. In some cases, the stops 519 and 521 may be configured to provide a seal (e.g., contamination-free and / or fluid-tight seal) between the first rod 501 and the tube 503.
[0060] The first and second curtains 505, 507 and the first and second drapes 509, 511 may be made of one or more sheets of polymer and / or fabric materials. For example, the curtains 505, 507 and drapes 509, 511 may be made one or more sheets (e.g., films) of polymer material that is / are easy to clean. In some examples, the polymer material may include a polyethylene film or sheet. In some examples, the curtains 505, 507 and / or drapes- 14 -SG Docket No.: 13668-737.600509, 511 may be made of one or more transparent or translucent materials such that features of the positioning apparatus may be seen therethrough. In some examples, the thickness of the curtains 505, 507 is sufficiently thick to remain upright and maintain the pleated configuration. In some cases, the material of the curtains 505, 507 is different (e.g., thicker) than the material of the drapes 509, 511.
[0061] As discussed, the barrier apparatus 500 can include a combination of flexible parts and rigid parts. For example, the first and second curtains 505, 507 and the first and second drapes 509, 511 may be made of flexible materials. In some cases, the first and second drapes 509, 511 may be made of more flexible material (e.g., thinner and / or different type of material) than the first and second curtains 505, 507. The rod 501, tube 503 and first and second mount interface members 513, 515 may be rigid so that they may maintain their shapes. In some cases, the first and second mount interface members 513, 515 are made of one or more rigid polymer materials (e.g., injection molded polymer(s)).
[0062] FIGS. 5B-5D show the barrier apparatus 500 positioned over a positioning apparatus that is configured to position a rigidizing tubular medical device (e.g., endoscope), as described herein. The positioning apparatus has a robotic assembly 551 that is coupled with a pneumatic tube assembly 552. The pneumatic tube assembly 552 can be configured to provide negative and / or positive pressure as part of a pneumatic system for controlling rigidizing and de-rigidizing the tubular medical device, as described herein. The robotic link assembly 551 includes a mount support 559 (e.g., third link) that includes a mount assembly. The mount assembly includes a first mount 553 and a second mount 555. The first mount 553 is located at a distal end region of the mount support 559, and therefore may correspond to distal end region of the robotic assembly 551, for example, when the robotic assembly 551 is laterally extended (e.g., toward a patient).
[0063] The first 553 and second 555 mounts may be configured to move (e.g., translate, slide) toward and away from each other, as described herein. For example, the second mount 555 may be configured to move towards and away from first mount 553. In some examples, the second mount 555 may be separately actuatable. The first 553 and second 555 mounts may be configured to couple with different features of the rigidizing tubular medical device. For example, the first mount 553 may be configured as an overtube mount for coupling with an overtube of the rigidizing tubular medical device, and the second mount 555 may be configured as an inner tube mount for coupling with an inner tube of the rigidizing tubular medical device.
[0064] Each of the first and second mounts 553, 555 include interface or engagement features (e.g., notches, knobs, clamps, clasps, latches, and / or locks) for coupling with- 15 -SG Docket No.: 13668-737.600different portions of the elongate medical instrument. For example, the first mount 533 may be configured to couple (directly or indirectly) with an overtube of the elongate medical instrument, and the second mount 555 may be configured to couple (directly or indirectly) with an inner tube of the elongate medical instrument.
[0065] The barrier apparatus 500 is positioned over the robotic assembly 551 such that the rod 501 and the tube 503 are positioned in line with a longitudinal axis of the mount support 559 of the robotic assembly 551. The first mount interface member 513 (e.g., first rigid interface) is coupled with the first mount 553 of the robotic apparatus, and the second mount interface member 515 (e.g., second rigid interface) is coupled with the second mount 555 of the robotic apparatus. Thus, the tube 503 translates over the rod 501 when the second mount interface member 515 is translated toward or away from the first mount 553.
[0066] The curtain stops 519, 521 and the tube 529 may be configured to translate with the second mount 555, thereby pushing against and causing the first and / or second curtains 505, 507 to compress (e.g., fold) and expand (e.g., unfold) accordingly. An end stop 508 on a proximal end region of the rod 501 can keep the proximal end of the second curtain 507 on the rod 501. In some cases, the end stop 508 (which also may be referred to as an end cap) may have a different shape and / or size than the curtain stops 519, 521. For example, the end stop 508 may be larger (e.g., longer and / or wider) than the curtain stops 519, 521 and be shape as a handle for easy handling by a user. The distal end of the first curtain 505 can terminate at the first mount 553, keeping the first curtain 505 on the rod 501.
[0067] In some examples, the curtain stops 519, 521 and / or the end stop 508 may each include two pieces (e.g., washers), with the corresponding curtain (505 or 507) sandwiched between the two pieces. This configuration can keep the corresponding curtain (505 or 507) in an upright position (e.g., vertical), thereby prevent the curtain from buckling.
[0068] When positioned on the robotic assembly 551, the first and second curtains 505, 507 can cover / block / occlude one side (e.g., inner side, e.g., facing the patient) of the mount support 559. For instance, in FIGS. 5B-5D, the second mount 555 is in a position that is extended proximally along a track 569 such that the first curtain 505 is expanded and blocks an inner-facing side / surface of the mount support 559 — in particular, on a distal part of the side / surface of the mount support 559 (e.g., including a distal part of the track 569). In this configuration, the second curtain 507 is in a contracted (e.g., more folded) state. If the second mount 555 were extended distally toward the first mount 553, the first curtain 505 can laterally contract (e.g., fold) and the second curtain 507 can laterally expand to block a proximal part of the inner-facing side / surface of the mount support 559 (e.g., including a proximal part of the track 569). In this way, the first and second curtains 505, 507 can- 16 -SG Docket No.: 13668-737.600continuously prevent material (e.g., bodily fluid and / or debris) from entering the track 569 whatever position the second mount 555 is in. This can prevent debris from contacting and / or entering, for example, the track 569 that would otherwise potentially hinder the movement of the second mount 555. The first and second curtains 505, 507 may also block material from contacting and / or entering electronic components of the positioning apparatus.
[0069] As shown in FIGS. 5B-5D, the first drape 509 covers the first mount 553 and the second drape 511 covers the second mount 555. The first and second drapes 509, 511 can block debris (e.g., bodily fluid and / or solid material) from contacting or entering electronic and / or mechanical components of the first mount 553 and the second mount 555. The first and second drapes 509, 511 can also prevent exposure of the respective first and second mounts 553, 555 from potentially infectious agents, thereby preventing or reducing crosscontamination. In this example, the second drape 511 includes a pocket region 517 that is configured to accommodate the one or more interface or engagement features of the second mount 555. For example, the pocket region 517 may include a frame and a double film to interact with one or more interface features (e.g., clamp or other type of securing mechanism).
[0070] The first mount interface member 513 (e.g., first rigid interface) can be secured to the first drape 509 (e.g., using adhesive), which may both be positioned over the first mount 553. Likewise, the second mount interface member 515 (e.g., second rigid interface) can be secured to the second drape 511 (e.g., using adhesive), which may both be positioned over the second mount 555. As shown, the first and second mount interface members 513, 515 includes openings of various shapes and sizes to provide access between the first and second mounts 553, 555 and the elongate medical instrument, with some of the openings are surrounded by a protruding rim or lip, for example, to provide a tight interface. For example, the protruding rims / lips may be configured so that the elongate medical instrument “clicks” into place and creates a seal.
[0071] Once the first mount interface member 513 is positioned on the first mount 553 and the second mount interface member 515 is positioned on the second mount 555, the rod support 536 can support the rod 501 at a height above a top of the inner-facing side of the mount support 559, and the tube support 538 can support the tube 503 at a corresponding height above the top of the inner-facing side of the mount support 559. The rod 501 and tube 503 may be aligned such that the tube 503 may slide over the rod 501.
[0072] FIGS. 6A-6I show features related to an example production of example curtains for the barrier apparatuses described herein. FIG. 6A shows example dimensions of each pleat of the curtains. In general, the dimensions of each pleat depend on the dimensions of the- 17 -SG Docket No.: 13668-737.600robotic positioning apparatus, and aspects related to covering portions of the positioning apparatus. Each pleat may have a height 603, for example, that is tall enough to block one side of the rod (e.g., inner side of the curtain, e.g., facing the patient). In some examples, the height 603 ranges from about 100 millimeters (mm) to about 140 mm (e.g., 100 mm, 110 mm, 120 mm, 125 mm, 130 mm, or 140 mm).
[0073] When welded together, the pleats may form flag portions 604, which protrude from a non-blocking side of the curtain that is opposite a blocking side of the curtain. The flag portions 604 provides material for holes for a rod. One side (e.g., top) of the pleat has a width 601 that is greater than a width 602 of an opposing side (e.g., bottom) of the pleat. In some examples, the width 601 ranges from about 40 mm to about 60 mm (e.g., 40 mm, 45 mm, 50 mm, 55 mm, or 60 mm). In some examples, width 602 ranges from about 30 mm to about 45 mm (e.g., 30 mm, 35 mm, 39 mm, 40 mm, or 45 mm). In some examples, a width of the flag portion 604 ranges from about 4 mm to about 8 mm (e.g., 4 mm, 5 mm, 6 mm, 7 mm, or 8 mm). The flag portions 604 may have a tapered shape (i.e., thinner ‘bottom’) so that the curtains do not rub against the positioning apparatus (e.g., mount support 559 (e.g., third link)).
[0074] FIG. 6B shows example dimensions of welding regions of a pleat. In some examples, a first top width 605 of a first weld region along a first edge 607 ranges from about 10 mm to about 14 mm (e.g., 10 mm, 12 mm, 13 mm, or 14 mm); a first bottom width 609 of the first weld region ranges from about 5 mm to about 8 mm, (e.g., 5 mm, 6 mm, 7 mm, or 8 mm); and a second width 606 along a second edge 608 ranges from about 2 mm to about 4 mm (e.g., 2 mm, 2.5 mm, 3 mm, 3.5 mm, or 4 mm).
[0075] FIG. 6C shows two pleats heat welded together, where the flag portion 604 protrudes in a direction away from a blocking side / surface 610 of the curtain. Thus, the flag portion 604 has a thickness of two sheets (double sheet). FIG. 6D shows multiple pleats welded together to form multiple flag portions 604 on a non-blocking side / surface 611 of the curtain, which is opposite the blocking side / surface 610 of the curtain. The depth of the curtain (e.g.,
[0076] FIG. 6E shows alternative views of example pleats. FIG. 6F shows examples views of a curtain, where holes 612 have been formed in the flag portions. In some examples, the holes 612 have a diameter ranging from about 7 mm to about 9 mm (e.g., 7 mm, 7.5 mm, 8 mm, 8.5 mm, or 9 mm). FIG. 6G shows an example of pleats welded together. One single sheet can be weld-cut to either end of the chain. FIG. 6H shows an example of a hole being formed (e.g., die-cut hole) through multiple flag portions of a- 18 -SG Docket No.: 13668-737.600curtain, where the pleats are compressed together. FIG. 61 shows a completed curtain with a rod running though the series of holes.
[0077] FIGS. 7A-9K show features related to an example production of an example second drape (e.g., drape 511 in FIGS. 5A-5D) for the barrier apparatuses described herein. FIG. 7A shows an example shape of a second drape, including a first opening 701 for an adaptor (e.g., for coupling the second mount interface member 515 to the second mount 555) and a second opening 702 for a pocket region (e.g., pocket region 517). FIG. 7B shows an example of a second drape 711 and an adaptor 712 for coupling a second mount interface member (e.g., 515) to a second mount (e.g., 555).
[0078] FIG. 7C shows the second drape 711 covering a second mount of the robotic positioning apparatus, with edges welded together to form a box shape. FIG. 7D shows another view of the second drape 711 covering the second mount and with the second mount interface member (e.g., 515) positioned over the second drape 711.
[0079] FIG. 7E shows a closeup view of the adaptor 712, showing alignment features 701a, 701b, 701c, and 701d along edges of the adaptor 712 to align the adaptor 712 with the second mount interface member (e.g., 515) and the second mount (e.g., 555). FIG. 7F shows another view of the adaptor 702, showing how it may include a beveled edge 703 to aid in interfacing / adhering to the second drape 711.
[0080] FIGS. 8A-8G show an example of forming and incorporating a pocket region into the second drape 711. FIG. 8 A shows example shapes of a first sheet 801 and a second sheet 802 of film. The second sheet 802 has a larger area to accommodate a frame. The first and second sheets 801, 802 may be made of different types of material and / or have different surface features. For example, in some examples, the first sheet 801 may be made of a first polymer (e.g., polyurethane type PU-10) and the second sheet 802 may be made of a second polymer (e.g., polyurethane type PU-04). In some examples, these different types of material and / or surface features provide different surface characteristics. For example, a surface of one of the first and second sheets 801, 802 may be tackier than a surface of the other. The tackier surface may allow the sheet to grip more securely to, for example, around a portion (e.g., inner tube) of the elongate medical instrument. Thus, this tackier sheet 801 or 802 may be arranged to contact the elongate medical instrument. In contrast, a surface of the other of the first and second sheets 801, 802 may be relatively smooth compared to the tackier sheet. The smoother sheet of the first and second sheets 801, 802 may be arranged to contact the interface feature (e.g., clamp) of the second mount (e.g., 333 or 555) so that the pocket region of the barrier apparatus can easily slide over the interface feature (e.g., using one hand).- 19 -SG Docket No.: 13668-737.600
[0081] FIG. 8B shows the first and second sheets 801, 802 welded together to form a double sheet assembly 803. FIG. 8C shows an example frame 804 with a double stick tape to both sides of the frame 804. FIG. 8D shows one side of the frame 804 adhered to the double sheet assembly 803. FIG. 8E shows the frame 804 and adhered double sheet assembly 803 where edges of the double sheet assembly 803 have been trimmed. The frame 804 defines a central opening that is shaped and sized to accommodate the interface feature (e.g., clamp) of the second mount (e.g., 333 or 555). The frame 804 may be more rigid than the first and second sheets 801, 802 so that the pocket region can be easily maneuvered over the interface feature (e.g., clamp) (e.g., using one hand). In addition, the frame 804 may make the pocket region visually identifiable.
[0082] FIG. 8F shows the frame 804 and adhered double sheet assembly 803 being positioned within the second opening 702 of the second drape 711. FIG. 8G shows the frame 804 and double sheet assembly 803 adhered in place (using the other side of the double stick tape of the frame 804) in the second drape 711, thereby forming a pocket region (e.g., 517 in FIGS. 5A-5D) for accommodating one or more interface or engagement features of the robotic positioning apparatus that interface / engage with the elongate medical instrument.
[0083] FIGS. 9 A and 9B show an example of coupling the second drape 711 to the tube 903 (e.g., tube 503 in FIGS. 5A-5D). FIG. 9A shows a top edge of the second drape 711 being folded over and welded (e.g., via heat) to create a completed folded region 902 and a region 901 in the process of being completed. FIG. 9C shows adhesive being applied to the tube 903, which is coupled with a second interface member 915 (e.g., second interface member 515) for adhering the second drape 711 to the tube 903. FIG. 9D shows an example curtain stop 919 (e.g., similar to curtain stops 519 or 521) being coupled to an end of the tube 903 via adhesive. FIG. 9E shows the second drape 711 that will be stretched and positioned over the tube 903 via a hole 930 within the second drape 711. Note that in this example the stop 929 has a different shape that the stop 919 in FIG. 9D. A double stick tape may be used to adhere the film of the second drape 711 to the stop 929. FIG. 9F shows a reinforcement tape 932 adhered and folded along a corner of the second drape 711 where it will be folded, to create a seal along the corner.
[0084] FIG. 9G shows a first (e.g., right) side of the second drape 711 where doublesided tape 934 is adhered along an edge 936 of the second drape 711 to connect it to a tab 938 of the second drape 711. FIG. 9H shows a region 939 on the second mount 955 (e.g., 555 of the robotic apparatus in FIGS. 5A-5D) for adhering the double-sided tape 934. FIG. 91 shows a reinforcement 940 being placed and folded over a corner of the second drape 711. FIG. 9J shows a second (e.g. left) side of the second drape 711 where another double-sided tape 942 - 20 -SG Docket No.: 13668-737.600is adhered along an edge 944 of the second side to connect it to the tab 938 of the second drape 711. FIG. 9K shows the completed second drape 711 positioned on the second mount of the positioning apparatus.
[0085] FIGS. 10A-11H show features related to an example production of an example second drape (e.g., drape 511 in FIGS. 5A-5D) for the barrier apparatuses described herein. FIG. 10A shows an example shape of a first drape (e.g., first drape 509 in FIGS. 5A-5D), including an opening 1001 for a first mount interface member (e.g., first mount interface member 513). FIG. 10B shows a first drape 1009 folded and welded at adjacent edges to fit over an underling first mount (e.g., first mount 553 in FIGS. 5B-5D). FIG. 10C shows edges of the first drape 1009 that are adhered to beveled edges of a first mount interface member 1013. FIG. 10D shows a reinforcement applied to a comer of the first drape 1009. FIG. 10E shows a reinforcement 1019 applied to an edge in line with a hole 1020 configured to accept the rod of the barrier apparatus. FIG. 10F shows a double-sided tape 1021 applied to a tab of the first drape 1009 to adhere the first drape 1009 to the first curtain (e.g., first curtain 505). FIG. 10G shows the first drape 1009 covering the first mount of the positioning apparatus.
[0086] FIG. 11 A shows adhesive applied to a distal end of a rod 1101 (e.g., rod 501 in FIGS. 5A-5D), where the rod 1101 is coupled to a rod support (e.g., rod support 536) of a first mount interface member (e.g., first mount interface member 513). The adhesive is used to adhere the first drape 1009 to the rod 1101. FIGS. 1 IB and 11C show aspects of aligning a hole 1110 of the first drape 1009 with a hole 1104 of a first curtain 1105 (e.g., first curtain 505). FIG. 1 ID shows the first curtain 1005 adhered to the first drape 1009 at a coupling region 1103, and aligned properly on the rod 1101. FIG. 1 IE and 1 IF show double sided tape used to adhere the first curtain 1105 to the first drape 1009 to be parallel at the coupling region, and with a hole 1104 of the first curtain aligned with a curtain stop. FIGS. 11G and 11H show the first (e.g., left) side and a second (e.g., right) side, respectively, of the first curtain 1105 adhered to respective first and second drapes.
[0087] It should be appreciated that all combinations of the foregoing concepts (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
[0088] The process parameters and sequence of steps described and / or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of- 21 -SG Docket No.: 13668-737.600the steps described or illustrated herein or include additional steps in addition to those disclosed.
[0089] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like. For example, any of the methods described herein may be performed, at least in part, by an apparatus including one or more processors having a memory storing a non-transitory computer-readable storage medium storing a set of instructions for the processes(s) of the method.
[0090] Also described herein are nested robot apparatus including one or more fluid barriers. For example, in general, the robotic apparatuses described herein (which may be rigidizing and / or nested robotic apparatuses) may include a tubular barrier member that extend along all or a portion of the length of the flexible (and in some cases rigidizing) member that may prevent leaking of material from the elongate member. The tubular barrier members may be formed of any of the same barrier materials described above, including a fluid-impermeable material and / or an absorbent material. For example, the barrier material may be a polymeric material.
[0091] A nested robot apparatus may include an outer member (e.g., overtube) and one or more inner members, such as an endoscope and / or a shield covering the endoscope. In some cases the shield may be a rigidizing shield. That extends over an endoscope to protect it and / or to convert it from a selectively rigidizing apparatus. The overtube may also or alternatively be rigidizing. The outer member may extend from a base that is configured to mount (see, e.g., the first actuating mount 323 in FIG. 3 A). The inner member may also extend from a base that is configured to extend from a mount (see, e.g., the second actuating mount 333 in FIG. 3A). Thus, when mounted to the robot, the second base (and therefore the inner member, e.g., shield / endoscope) may move independently of the first base (and therefore the outer member, e.g., overtube) in the longitudinal and / or roll axes. The first and second bases (and thus the inner and outer member) may also be configured to move together by moving the link to which they are attached through the mounts, as described above. The first and second member may be at least partially covered by a barrier.
[0092] For example, described herein are nested apparatuses configured to couple to a medical robot having one or more barriers, that may include: a first base configured to couple- 22 -SG Docket No.: 13668-737.600to a medical robot, a first tubular member extending from the first base, wherein the first tubular member is flexible; a second base configured to couple to the medical robot; a second tubular member extending from the first base, wherein the second tubular member is steerable and inserted through the first base and the first tubular member; a first barrier tube, wherein the first barrier tube extends over the second tubular member between the first base and the second base, further wherein the first barrier tube is configured to change length as a spacing between the first base and the second base is changed.
[0093] For example, FIGS. 12A-12C illustrate a nested robot apparatus including a fluid barrier that may be mounted to a medical robot such as those shown above in FIGS. 1 A-1B, 3A-3C, 4A-4C and 5A-5D. In this example, the nested robot apparatus includes a first base 1252 from which a first elongate, flexible member (e.g., overtube) 1262 extends. The first base may couple to the medical robot, such as a mount on the medical robot, and may may connections (or may include connections) for one or more pressure line, fluid line, electrical line (e.g., for sensing, power, etc.). The nested robot apparatus also includes a second base 1251 from which a second elongate member 1261 extends and passes through the first base and the first elongate member. This second elongate member may be steerable and the second base may include one or more controls for steering at least the distal end region of the second elongate member (e.g., tendon spools, etc.).
[0094] The apparatus shown in FIGS. 12A-12C also includes a first barrier 1270 that is connected between the first base 1252 and the second base 1251, covering the region of the second elongate member 1261 that extends between the two. As the bases are moved relative to each (e.g., moving 1267 the second base relative to the first base), the first barrier may extend and contract over them. In some cases the first barrier has a tubular accordion-like (e.g., pleated) structure. In some cases the first barrier is elastic.
[0095] The apparatus may also include a second barrier 1274 that extends at least partially 1272 down the length of the first elongate member 1262. In this example the second barrier may be tubular and may or may not be an accordion-like structure or it may be smooth. The second barrier may extend a predefined length 1272 the covers a portion of the outer elongate member that may be, e.g., held by a support arm. The distal end of the second barrier may include a ring 1276 that may fit loosely or in some cases snugly (e.g., sealingly) over the outer member.
[0096] FIG. 12A shows the apparatus with first base 1252 coupled in-line to the second base 1251. In some cases the apparatus may include a delivery or packaging configuration in which the first base and the second base are removably coupled together; they may be separated upon mounting to the medical robot. In FIG. 12B the apparatus is shown with the - 23 -SG Docket No.: 13668-737.600first base 1251 separately somewhat from the second base 1251. Moving the second base longitudinally away from the first base may foreshorten the region of the inner member 1261 (second elongate member) extending out of the outer member 1262 (e.g., first elongate member). This is further illustrated in FIG. 12C. As the first and second bases separate, 1269, the first barrier 1270 lengthens to keep the inner member covered by the barrier, potentially capturing any material that may otherwise leak from the inner member 1261, e.g., lubricating fluid, biological material, etc.
[0097] FIGS. 13A-13B show another example of an apparatus including first and second tubular barrier. In FIG. 13 A the first base 1252 is shown separated from the second base 1251 and a first barrier (tubular barrier cover 1270) extends between the two bases over an inner member (e.g., second elongate member 1261). A second tubular barrier 1274 is shown covering the outer elongate member (e.g., first elongate member 1262). As shown in FIG. 13B, only the proximal end of the outer elongate member is covered by the second barrier; the distal end of the barrier includes a ring 1276’ that is configured to mount to the holding arm 1281. In this example the outer member is a rigidizing overtube that can be dynamically rigidized (e.g., by the application of positive and / or negative pressure) between a flexible configuration and a rigid configuration. The inner member is a rigidizing sheath covering an endoscope. The rigidizing sheath may also be dynamically rigidized, e.g., by the application of positive and / or negative pressure.
[0098] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
[0099] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the - 24 -SG Docket No.: 13668-737.600singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.
[0100] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
[0101] Although the terms “first” and “second” may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element discussed below could be termed a second feature / element, and similarly, a second feature / element discussed below could be termed a first feature / element without departing from the teachings of the present invention.
[0102] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
[0103] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and / or steps may- 25 -SG Docket No.: 13668-737.600alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.
[0104] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and / or position to indicate that the value and / or position described is within a reasonable expected range of values and / or positions. For example, a numeric value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
[0105] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.- 26 -SG Docket No.: 13668-737.600
[0106] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.- 27 -SG Docket No.: 13668-737.600
Claims
CLAIMSWhat is claimed is:
1. A barrier apparatus for covering at least a portion of positioning apparatus for positioning an endoscope, the positioning apparatus comprising: a mount assembly including an overtube mount and an inner tube mount, wherein the inner tube mount is configured to translate proximally and distally relative to the overtube mount; and a mount support having a side from which the overtube mount and the inner tube mount laterally extend, the side of the mount support comprising a track that defines a path of translation of the inner tube mount, wherein the barrier apparatus comprises: a rod assembly including a rod within a tube, wherein the tube is configured to couple with the inner tube mount of the mount assembly, and wherein the tube is configured to slidably translate over the rod when the inner tube mount translates; and first and second curtains slidably coupled with the rod, the first curtain configured to be positioned distally with respect to the inner tube mount, and the second curtain configured to be positioned distally with respect to the inner tube mount, wherein the first and second curtains are configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris.
2. The barrier apparatus of claim 1, wherein the barrier apparatus further comprises first and second drapes, wherein the first drape is configured to cover the overtube mount of the positioning apparatus, and the second drape is configured to cover the inner tube mount of the positioning apparatus.
3. The barrier apparatus of claim 2, wherein the second drape includes a pocket region including a frame that defines a perimeter for accommodating one or more interface features of the inner tube mount.
4. The barrier apparatus of claim 2, wherein the second drape includes a pocket region including a film made of two polymer sheets having different surface characteristics.
5. The barrier apparatus of claim 2, further comprising first and second mount interface members, wherein the first mount interface member is configured to couple to the- 28 -SG Docket No.: 13668-737.600overtube mount over the first drape, and the second mount interface member is configured to couple to the inner tube mount over the second drape.
6. The barrier apparatus of claim 5, wherein the first mount interface member includes a rod support that is coupled with the rod, and the second mount interface member includes a tube support coupled with the tube, wherein the rod support and the tube support support the rod and tube at a predetermined height with respect to the overtube mount and an inner tube mount.
7. The barrier apparatus of claim 5, wherein the first mount interface member includes features configured to couple with an overtube of the endoscope, and the second mount interface member includes features configured to couple with an inner tube of the endoscope.
8. The barrier apparatus of claim 2, wherein a proximal edge of the first drape is sealed to the first curtain, a distal edge of the second drape is sealed to the first curtain, and a proximal edge of the second drape is sealed to the second curtain.
9. The barrier apparatus of claim 1, wherein the rod assembly includes first and second curtain stops that are configured to push against respective first and second curtains, thereby causing the first and second curtains to laterally contract.
10. The barrier apparatus of claim 1, wherein each of the first and second curtains include a plurality of flag portions that extend from a non-blocking side of that is opposite a blocking side of the respective first and second curtains, wherein the plurality of flag portions include holes through which the rod runs through.
11. The barrier apparatus of claim 1, wherein each of the first and second curtains include a plurality of pleats that provide organized expansion and contraction of the first and second curtains.
12. A system for positioning an endoscope, the system comprising: a positioning apparatus configured to position the endoscope, the positioning apparatus comprising: a mount assembly comprises an overtube mount and an inner tube mount, wherein the inner tube mount is configured to translate proximally and distally relative to the overtube mount; and- 29 -SG Docket No.: 13668-737.600a mount support having a side from which the overtube mount and the inner tube mount laterally extend, the side of the mount support comprising a track that defines a path of translation of the inner tube mount; and a barrier apparatus configured to cover at least a portion of the mount assembly, the barrier apparatus comprising: a rod assembly including a rod within a tube, wherein the tube is configured to couple with the inner tube mount of the mount assembly, and wherein the tube is configured to slidably translate over the rod when the inner tube mount translates; and first and second curtains slidably coupled with the rod, the first curtain positioned distally with respect to the inner tube mount, and the second curtain positioned distally with respect to the inner tube mount, wherein the first and second curtains are configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris.
13. The system of claim 12, wherein the barrier apparatus further comprises first and second drapes, wherein the first drape is configured to cover the overtube mount of the positioning apparatus, and the second drape is configured to cover the inner tube mount of the positioning apparatus.
14. The system of claim 13, wherein the second drape includes a pocket region including a frame that defines a perimeter for accommodating one or more interface features of the inner tube mount.
15. The system of claim 13, further comprising first and second mount interface members, wherein the first mount interface member is configured to couple to the overtube mount over the first drape, and the second mount interface member is configured to couple to the inner tube mount over the second drape.
16. The system of claim 13, wherein a proximal edge of the first drape is sealed to the first curtain, a distal edge of the second drape is sealed to the first curtain, and a proximal edge of the second drape is sealed to the second curtain.
17. The system of claim 12, wherein the overtube mount is configured to couple with an outer member of the endoscope, and wherein the endoscope mount is configured to couple with- 30 -SG Docket No.: 13668-737.600an inner member of the endoscope, wherein steering the endoscope includes controlling distal movement of the inner member relative to the outer member.
18. The system of claim 17, wherein the inner tube mount includes one or more controls for controlling rigidizing and de-rigidizing of one or both of the inner and outer members of the endoscope.
19. The system of claim 12, wherein the rod assembly includes first and second curtain stops that are configured to push against respective first and second curtains, thereby causing the first and second curtains to laterally contract.
20. The system of claim 12, wherein each of the first and second curtains include a plurality of flag portions that extend from a non-blocking side of that is opposite a blocking side of the respective first and second curtains, wherein the plurality of flag portions include holes through which the rod runs through.
21. The system of claim 12, wherein each of the first and second curtains include a plurality of pleats that provide organized expansion and contraction of the first and second curtains.
22. The system of claim 12, wherein the positioning apparatus includes a telescoping link assembly comprising a plurality of adjacent links slidably coupled together, wherein the plurality of links are configured to extend from a compact configuration, wherein the mount assembly is on a most distally extending link of the plurality of links.
23. The system of claim 22, further comprising a linear driver configured to drive relative movement of the plurality of links.
24. A method of covering a positioning apparatus for positioning an endoscope with a barrier apparatus, the positioning apparatus comprising: a mount assembly including an overtube mount and an inner tube mount, wherein the inner tube mount is configured to translate proximally and distally relative to the overtube mount; and a mount support having a side from which the overtube mount and the inner tube mount laterally extend, the side of the mount support comprising a track that defines a path of translation of the inner tube mount, wherein the method comprises: coupling a first mount interface member and a first drape of the barrier apparatus to the overtube mount, wherein the first drape is a first sheet of material that covers- 31 -SG Docket No.: 13668-737.600surfaces of the overtube mount, and the first mount interface member is a first rigid platform configured to couple with an overtube of the endoscope, wherein the first mount interface member includes a rod support that supports a rod above the mount support of the positioning apparatus; and coupling a second mount interface member and a second drape of the barrier apparatus to the inner tube mount, wherein the second drape is a second sheet of material that covers surfaces of the inner tube mount, and the second mount interface member is a second rigid platform configured to couple with an inner tube of the endoscope, wherein the second mount interface member includes a tube support that supports a tube above the mount support of the positioning apparatus, wherein the tube has the rod positioned therein such that the tube can slidably translate over the rod when the inner tube mount translates, wherein a first curtain is slidably coupled with the rod at a position distal to the second mount interface member, and a second curtain is slidably coupled with the rod at a position proximal to the second mount interface member, wherein the first and second curtains are configured to laterally expand and contract as the inner tube mount translates along the track, thereby blocking distal and proximal portions of the track from debris.
25. The method of claim 24, wherein the first and second mount interface members are coupled with respective overtube and inner mounts using fasteners.
26. The method of claim 24, wherein the second drape includes a pocket region including a frame that defines a perimeter for accommodating one or more interface features of the inner tube mount.
27. The method of claim 24, wherein rod support and the tube support support the rod and tube at a predetermined height with respect to the overtube mount and an inner tube mount.
28. The method of claim 24, wherein the first mount interface member includes features configured to couple with the overtube of the endoscope, and the second mount interface member includes features configured to couple with the inner tube of the endoscope.
29. The method of claim 24, wherein a proximal edge of the first drape is sealed to the first curtain, a distal edge of the second drape is sealed to the first curtain, and a proximal edge of the second drape is sealed to the second curtain.- 32 -SG Docket No.: 13668-737.60030. The method of claim 24, wherein the rod and tube include first and second curtain stops that are configured to push against respective first and second curtains, thereby causing the first and second curtains to laterally contract when the inner tube mount translates.
31. The method of claim 24, wherein each of the first and second curtains include a plurality of flag portions that extend from a non-blocking side of that is opposite a blocking side of the respective first and second curtains, wherein the plurality of flag portions include holes through which the rod runs through.
32. The method of claim 24, wherein each of the first and second curtains include a plurality of pleats that provide organized expansion and contraction of the first and second curtains.
33. A nested apparatus including a fluid barrier, the apparatus comprising: a first base configured to couple to a medical robot; a first tubular member extending from the first base, wherein the first tubular member is flexible; a second base configured to couple to the medical robot; a second tubular member extending from the first base, wherein the second tubular member is steerable and inserted through the first base and the first tubular member; a first barrier tube, wherein the first barrier tube extends over the second tubular member between the first base and the second base, further wherein the first barrier tube is configured to change length as a spacing between the first base and the second base is changed.
34. The apparatus of claim 33, wherein the first tubular member comprises an overtube.
35. The apparatus of claim 33, wherein the first tubular member is configured to rigidize.
36. The apparatus of claim 33, wherein the second tubular member comprises an endoscope or an endoscope shield.
37. The apparatus of claim 33, wherein the second tubular member is configured to rigidize.
38. The apparatus of claim 33, wherein the first barrier tube is formed of a fluid-impermeable material.- 33 -SG Docket No.: 13668-737.60039. The apparatus of claim 33, wherein the first barrier tube is formed of an absorbent material.
40. The apparatus of claim 33, further comprising a second barrier tube extending from the second base over the first tubular member.
41. The apparatus of claim 40, wherein the second barrier tube extends only partially over a length of the first tubular member.
42. The apparatus of claim 33, wherein the first barrier tube comprises an accordion pleating.
43. The apparatus of claim 33, wherein the first base and the second base are releasably coupled together with the first barrier tube compressed between them in an initial configuration.
44. A nested apparatus including a fluid barrier, the apparatus comprising: a first base configured to couple to a medical robot; a first tubular member extending from the first base, wherein the first tubular member is flexible; a second base adjacent to the first base and configured to couple to the medical robot; a second tubular member extending from the first base, wherein the second tubular member is steerable and inserted through the first base and the first tubular member; a first barrier tube formed of a fluid-impermeable material, wherein the first barrier tube extends over the second tubular member between the first base and the second base, further wherein the first barrier tube is configured to change length as a spacing between the first base and the second base is changed.- 34 -SG Docket No.: 13668-737.600
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