Device and method for providing a volume in a lumen

Abstract

A device is provided that provides a volume in a lumen for endoscopic procedures. The device includes a plurality of flexible tube links, each of the flexible tube links having a distal end and a proximal end; an actuation and locking mechanism including an actuation wire, wherein the proximal end of each flexible tube link is connected to the actuation and locking mechanism, wherein the actuation wire is connected around the distal side of each flexible tube link, and wherein the actuation wire is arranged to rotate relative to the actuation and locking mechanism to define the volume.

Description

[0001] Priority requirements This application claims priority to Singapore Patent Application No. 10202101738X, filed on February 22, 2021. Technical Field

[0002] The present invention generally relates to forming working sites in collapsible tube structures such as lumens, and more specifically to apparatus and methods for providing volume in lumens. Background Technology

[0003] Working with collapsible catheters, especially small ones, is challenging because the walls tend to collapse on their own, making it difficult to maintain a sufficient volume within the catheter as a working space. This becomes complicated when the catheter is extremely small (e.g., within a body lumen) and when working within the catheter from a remote location outside the catheter.

[0004] Examples of working within a small, collapsible catheter from a remote location outside the catheter include delivering a non-invasive endoscope into the lumen for visualization and delivering instruments (i.e., grippers, cutters, cauterization tools, ultrasound probes, etc.) for tissue manipulation.

[0005] Compared to other bodily lumens, the gastrointestinal (GI) tract has a relatively large lumen. Assessment and treatment of the GI tract are hampered by the regional and local anatomical geometry and surface condition of the colon. Furthermore, the colon is divided into several parts (ascending colon, transverse colon, descending colon, and sigmoid colon), each with a regional bend and multiple folds in between. Additionally, the colonic tissue is viscoelastic, and its condition varies depending on its location.

[0006] Because of these factors, fully visualizing the colon wall using conventional endoscopy is challenging. When the endoscope is inserted into the colon, the colon may contract due to spasms and peristalsis. This contraction makes visibility more difficult and limits the access of the inserted endoscope to the target tissue within the workspace.

[0007] Furthermore, during endoscopic procedures, the surrounding tissues in the GI channel may collapse due to the weight in the GI channel and intra-abdominal pressure (IAP), thereby obstructing the field of vision and task space required to perform the surgery properly.

[0008] Colonic insufflation has been used to access target tissues while avoiding spasms and peristalsis. Gas insufflation is one form of insufflation in which a gas, such as carbon dioxide, is used to expand the lumen for better visualization and to facilitate colonoscopy. Carbon dioxide is a common choice for insufflation because it is quickly absorbed into the bloodstream by the gastrointestinal mucosa and then exhaled into the lungs. However, using carbon dioxide as an insufflation gas has significant disadvantages, such as abdominal distension and postoperative pain due to embolism. Furthermore, individuals with pre-existing conditions such as chronic obstructive pulmonary disease may be more susceptible to carbon dioxide retention. Additionally, perforation during endoscopic procedures, whether intentional or unintentional, can cause insufflation gas to escape into the peritoneal cavity, making it more difficult to maintain intraluminal space and potentially leading to cardiac distress.

[0009] Therefore, there is a need for an apparatus and method capable of expanding a body lumen or a flexible, collapsible catheter to expose and maintain a working space, such as forming a volume within the lateral wall tissue of the lumen for endoscopic diagnosis, treatment, and surgery without the need for air intubation. Having an expanded and stable intraluminal space provides appropriate visualization of the target area (e.g., target tissue) and the surrounding lateral walls, and the formation of a volume within the flexible, collapsible catheter for a suitable working space allows for independent manipulation of delivery mechanisms (e.g., endoscopes or catheters or similar flexible components) as well as tools or other instruments. Furthermore, other desirable features and characteristics will become apparent from the following detailed description and appended claims, taken in conjunction with the accompanying drawings and the background art of this disclosure. Summary of the Invention

[0010] According to at least one aspect of this embodiment, an apparatus is provided for providing a volume in a lumen for endoscopic manipulation. The apparatus includes: a plurality of flexible tube linkages, each having a distal end and a proximal end; an actuation and locking mechanism including an actuation wire, wherein the proximal end of each flexible tube linkage is connected to the actuation and locking mechanism, wherein the actuation wire is connected to a substantially distal side of each flexible tube linkage, and wherein the actuation wire is arranged to rotate relative to the actuation and locking mechanism to define a volume.

[0011] According to other aspects of this embodiment, a method is provided for providing a volume in a lumen for endoscopic manipulation. The method includes the steps of: advancing a device to a target site; and rotating an actuation and locking mechanism such that the distal ends of a plurality of flexible tube linkages are abutted against the proximal ends of the plurality of flexible tube linkages, thereby forming a defined volume. Attached Figure Description

[0012] The accompanying drawings are used to illustrate various embodiments and explain the various principles and advantages according to the embodiments. In the various individual views, similar reference numerals refer to the same or functionally similar elements, and the drawings, together with the following detailed description, are incorporated in and form a part of the specification.

[0013] Figure 1A and Figure 1B This is a perspective view of the body lumen expansion device according to this embodiment.

[0014] Figures 2A to 2D This is a photograph showing the unfolding process of the flexible main structure of the lumen expansion device according to this embodiment.

[0015] Figure 3A and Figure 3B These are left and right views of the flexible tube linkage of the lumen expansion device according to this embodiment.

[0016] Figure 4A and 4B This is an exploded cross-sectional view of the actuation and locking mechanism of the lumen expansion device according to this embodiment.

[0017] Figure 5 This is a perspective view of the control lever and control tube of the lumen expansion device according to this embodiment.

[0018] Figures 6A to 6C The process of connecting the joystick and control tube to the lumen expansion device prior to delivery, according to this embodiment, is described.

[0019] Figure 7A This is a cross-sectional view of the actuation and locking mechanism of the lumen expansion device according to this embodiment. Figure 7B This is an external view of the lumen expansion device according to this embodiment before it is deployed.

[0020] Figure 8A This is a cross-sectional view of the actuation and locking mechanism according to FIG7 of this embodiment. Figure 8B This is an external view of the lumen expansion device according to this embodiment when fully expanded.

[0021] Figure 9A This is a cross-sectional view of the actuation and locking mechanism of the lumen expansion device according to this embodiment. Figure 9B This is an external view of the lumen expansion device according to this embodiment when the lumen expansion device is fully deployed and the lock is activated.

[0022] Figure 10A and Figure 10B This is a schematic diagram of the expanded lumen device according to this embodiment, wherein, Figure 10A This is a perspective view taken from the near side. Figure 10B This is a perspective view taken from the distance.

[0023] Figure 11A and Figure 11B The process of disconnecting the actuation line to release tension according to this embodiment is shown.

[0024] Figure 12A and Figure 12B The process of connecting the device to the joystick and tube according to this embodiment for retraction is shown.

[0025] Figure 13 This is a cross-sectional view of the lumen expansion device unfolded according to this embodiment, near the side.

[0026] Figure 14 This is a cross-sectional view of the left side of the expanded lumen expansion device according to this embodiment.

[0027] Figure 15 This is a cross-sectional view of the right side of the expanded lumen expansion device according to this embodiment.

[0028] Figure 16 This is a cross-sectional view of the distal side of the expanded lumen device according to this embodiment.

[0029] Figure 17 This is a diagonal cross-sectional view of the left linkage of the expanded lumen device according to this embodiment.

[0030] Figure 18 This is a diagonal cross-sectional view of the right linkage of the expanded lumen device according to this embodiment.

[0031] Figure 19 This is a perspective view of the actuation line when the lumen expansion device is deployed according to this embodiment.

[0032] Figure 20 This is a perspective view of the tissue blocking line when the lumen dilation device is deployed according to this embodiment.

[0033] Figure 21 According to this embodiment, when the lumen expansion device is deployed... Figure 19 actuation line and Figure 20 A perspective view of the tissue barrier lines.

[0034] Figure 22 This is a perspective view of the flexible main structure when the lumen expansion device is deployed according to this embodiment.

[0035] Figure 23 This is a perspective view of the flexible main structure, actuation line, and tissue barrier line when the lumen expansion device is deployed according to this embodiment.

[0036] Figure 24This is a perspective view of the flexible main structure, actuation base, actuation rod, actuation line, and tissue blocking line when the lumen expansion device according to this embodiment is deployed.

[0037] Figure 25A and Figure 25B This is a photograph of the unfolded structure of the lumen expansion device according to this embodiment, which has a small distal side and a large proximal side with rounded connecting edges.

[0038] Figures 26A to 26C Another embodiment of the connection between the locking cap and the control tube according to this embodiment is shown.

[0039] Figure 27A and Figure 27B Another embodiment of the actuation base and locking cap according to this embodiment is shown, wherein the locking cap engages with the actuation base.

[0040] Figures 28A to 28C Another method is shown for connecting the lumen expansion device according to this embodiment to an operating rod by utilizing magnetic attraction.

[0041] Figure 29A This is an exploded view of another embodiment of the actuation and locking mechanism for a lumen expansion device according to this embodiment. Figure 29B The embodiment includes an actuation line and a tension line. Figure 29A An exploded view of the actuation and locking mechanism. Figure 29C It is arranged in a closed coupling according to this embodiment. Figure 29A A perspective view of the actuation and locking mechanism.

[0042] Figures 30A to 30D A lumen expansion device according to this embodiment is shown. Figures 29A to 29C The tensioning, locking, and disengaging sequence of embodiments of the actuation and locking mechanism.

[0043] Those skilled in the art will understand that the elements in the accompanying drawings are shown for simplicity and clarity and are not necessarily depicted to scale. Detailed Implementation

[0044] The following detailed description is merely exemplary in nature and is not intended to limit the invention or its application and use. Furthermore, it is not intended to be limited by the foregoing background information or any theory set forth in the following detailed description. The object of this embodiment is to provide an apparatus and method for defining a structure to provide volume within a collapsible tubular structure (e.g., a lumen).

[0045] According to one embodiment of the invention, the device includes a flexible master structure, an actuation and locking mechanism, and a delivery / manipulation tool. The flexible master structure includes multiple flexible frames that can pop out from a closed, collapsed structure into a three-dimensional (3D) structure, thereby forming a volume within a lumen for endoscopic manipulation. Each flexible frame can be pre-formed, or it can be an linkage with multiple rotary joints. The rotary joints can be formed by slots (a joint can have one or more slots) or pin joints. The flexible frames are linked together to form the final 3D structure. The transformation of the flexible master structure is powered by an external power source, and the final 3D structure is contained by activation of the locking mechanism. The flexible master structure can be completely detached from the delivery tool. After endoscopic manipulation, the final 3D structure can be unlocked, and the flexible master structure can be retrieved using the manipulation tool. All components are sufficiently flexible and / or small enough to pass through the instrument channel of the endoscope.

[0046] According to another embodiment of the invention, the flexible main structure / frame consists of two tandem linkages, each having four swivel joints formed by slots. The linkages are made of a high-strength flexible material (i.e., PET or superelastic nitinol rods, bars, or tubes). One linkage's joint is configured to form a shape with a front upper left diagonal to the lower right. Conversely, the other linkage is designed to form a shape / structure with a front upper right diagonal to the lower left. These linkages are placed adjacent to each other and connected by elastic elements (e.g., wires or cords preferably made of nitinol alloy) to maintain their proper relative positions. When all joints are at their maximum limits, the linkage transforms from a closed, collapsed structure into a cuboid tent-like shape / structure. Furthermore, flexible rods, bars, or tubes can be added to reinforce the bottom surface of the structure. Alternatively, the deployable shape / structure, i.e., the final 3D shape, includes triangular prisms, pyramids, cylinders, tents, and dome-shaped shapes or structures, depending on the number and length of the linkages / frame and the number, placement, and rotational constraints of the joints. Joint actuation is performed by tensioning a line, wherein the line is high-strength, low-tensile, and the flexible line comprises highly elastic nitinol or synthetic / metallic cord, which passes through the frame. When the line is pulled, the structure pops out, the tip of the frame is pulled proximally, and the joint of the tent structure is forced to rotate to its limit.

[0047] According to another embodiment of the invention, the actuation and locking mechanism comprises three components: an actuation base, an actuation rod, and a locking cap. The length of the line required to be pulled from a closed, collapsed shape to an unfolded tent shape is approximately the same as the length of the closed, collapsed shape of the structure. To keep the device as short as possible, actuation is triggered by winding the line. The distal end of the actuation base is connected to a flexible main structure. At the proximal end, the actuation base has a threaded hole in a central groove on its outer surface to guide the actuation line out from the flexible main structure. A ridge immediately adjacent to the groove serves as a guide for the locking cap. The actuation rod has a screw and a key immediately adjacent to the screw at its distal end. The screw is fitted into the threaded hole on the actuation base, and the actuation line terminates at the key. The majority of the screw is initially placed within the threaded hole of the actuation base. As the screw is loosened, more threads are exposed, while the actuation line winds around the screw. The locking cap includes a guide groove and a keyway. After the device is fully deployed, the locking cap slides into the ridge of the actuating base until the key on the actuating rod fits into a keyway, making the screw unable to rotate.

[0048] According to another embodiment of the invention, the actuation and locking mechanism consists of two components: an L-shaped socket actuation base and a T-shaped lock. The distal end of the L-shaped socket actuation base is connected to a flexible main structure. A wire / filament passes through holes in the L-shaped socket actuation base and the T-shaped lock. The wire / filament is twisted into a bundle by rotating an actuating tool attached to the T-shaped lock. After the wire / filament is twisted into a bundle, the T-shaped lock is pushed into the L-shaped socket to prevent the wire / filament from twisting in the opposite direction. The frictional force generated by the twisting prevents the wire / filament from slackening, thereby maintaining tension. Therefore, pulling the wire / filament with a linear motion keeps the wire in a twisted state and in a locked configuration. Furthermore, because the wire / filament is twisted into a bundle, the deployed device is shorter, and this allows the deployed device to pass through narrow, sharp bends.

[0049] According to another embodiment of the invention, tissue compression into the space formed in the unfolded structure is prevented from entering the space by another loop of lines / wires intersecting the surfaces of the structure. While the proximal side of the structure remains open for access by endoscopes and instruments, the spacing of the tissue-blocking lines / wires intersecting the other surfaces of the structure can be adjusted according to the condition of the surrounding tissue and surgical requirements (i.e., the type, size, and condition of the lesion). The tissue-blocking lines / wires also need to be tensioned to retain tissue compression. This tension can be provided by terminating the lines at the actuation rod and coupling them with a linear loosening motion. Alternatively, the tensioning can be performed using the same process as tensioning the actuation lines / wires. In both cases, the actuation and locking mechanism maintains the tension of the actuation lines / wires and the tissue-blocking lines / wires after the flexible main structure has unfolded.

[0050] According to another embodiment of the invention, all manipulations of the device, including delivery, deployment actuation, locking, separation, tension release and retraction, are performed via the endoscopic channel using a manipulation tool and are performed proximally outside the endoscope.

[0051] Due to recent advances in endoscopic techniques, such as diagnostic and therapeutic endoscopy and natural orifice endoscopic surgery (NOTES), new treatment methods and procedures have been developed. Assessment and treatment of the GI tract are hampered by the regional and local anatomical geometry and surface condition of the colon. Furthermore, colonic tissue is viscoelastic, and its condition varies depending on its location. Full visualization of the colonic wall using conventional endoscopes is challenging because the colon may contract due to spasms and peristalsis, making visibility more difficult and limiting the access of inserted endoscope instruments to target tissue within the workspace. This embodiment provides apparatus and methods for expanding the body lumen during endoscopic diagnosis, treatment, and surgery to provide a workspace volume within the lumen.

[0052] Reference Figure 1A Embodiments of the present invention include a flexible master structure 100, an actuation and locking mechanism 200, an operating tube 300, and a joystick 400 according to this embodiment. The flexible master structure 100 and the actuation and locking mechanism 200 are located at the distal end of a flexible component such as an endoscopic device (e.g., an endoscope), a catheter, or a similar flexible component, and can be delivered into a workspace within a lumen or similar soft, collapsible catheter, and are controlled by a user via the operating tube 300 and the joystick 400 located at the proximal end of the flexible component.

[0053] Figure 1BDetails of the flexible main structure 100 and the actuation and locking mechanism 200 according to this embodiment are shown. An actuation line 180 terminates at the actuation and locking mechanism 200 and passes through the left flexible tube linkage 110, the right flexible tube linkage 140, the side tube frames 170 and 171, and the distal tube frame 172. Each of the left flexible tube linkage 110 and the right flexible tube linkage 140 includes a distal end and a proximal end, wherein the proximal end of each of the left flexible tube linkage 110 and the right flexible tube linkage 140 is connected to the actuation and locking mechanism 200, and wherein the distal end of the actuation line 180 is connected to the distal end of the left flexible tube linkage 110 and the right flexible tube linkage 140. The distal tube frame 172 is coupled to at least one of the proximal ends of the left flexible tube linkage 110 and the right flexible tube linkage 140. The tissue blocking line 181 terminates at the actuation and locking mechanism 200, and passes through the interior and exterior of the left flexible tube linkage 110 and the right flexible tube linkage 140. The left flexible tube linkage 110 and the right flexible tube linkage 140 are connected to the flexible elastic line 182 to limit their relative position. Alternatively, there may be multiple flexible tube linkages. Alternatively, the left and right flexible tube linkages may be a single structure. Alternatively, the flexible main structure 100, the actuation and locking mechanism 200, the control tube 300, and the control lever 400 may be coupled to form a single structure. According to this embodiment, the left flexible tube linkage 110, the right flexible tube linkage 140, the side tube frames 170 and 171, and the distal tube frame 172 include a closed collapsible structure that is delivered into the workspace within the flexible main structure 100. In the workspace, the actuation line 180 is manipulated by the user at the proximal end of the flexible component to convert the closed collapsible structure into a 3D (three-dimensional) unfolded structure, thereby advantageously forming a workspace volume within a lumen or other small collapsible conduit.

[0054] Figures 2A to 2D This describes the flexible main structure 100 of the device as it transforms from a closed, collapsed structure into a three-dimensional (3D) unfolded structure. Figure 2D Each step during the process ( Figure 2A , Figure 2B , Figure 2C , Figure 2D(Image of a photograph). The actuation and locking mechanism 200 is arranged to rotate relative to the left flexible tube linkage 110 and the right flexible tube linkage 140 to pull the distal end of the actuation line 180 toward the actuation and locking mechanism 200, thereby moving the distal end of each of the left flexible tube linkage 110 and the right flexible tube linkage 140 toward the proximal end of each of the left flexible tube linkage 110 and the right flexible tube linkage 140, thereby forming a structure defined by each of the left flexible tube linkage 110 and the right flexible tube linkage 140, thus defining a volume. In the defined structure, i.e., the 3D unfolding configuration, the tissue blocking line 181 is vertically connected to the left flexible tube linkage 110 and the right flexible tube linkage 140. When the actuation and locking mechanism 200 rotates, the tension increases, thereby providing rigidity to the structure defined by each of the flexible tube linkages 110, 140 and by the side tube frames 170, 171 and the distal tube frame 172. Alternatively, the actuation line 180 may be an actuation filament, the tissue blocking line 181 may be a structural filament, and the volume may be an intraluminal space.

[0055] Reference Figure 3A and Figure 3B According to this embodiment, both the left flexible tube linkage 110 and the right flexible tube linkage 140 include five flexible linkage portions 111 to 115 and 141 to 145, and four rotating elements with rotary joints 116 to 119 and 146 to 149. The rotating elements can be formed by pin joints or slots, wherein each rotating element connects adjacent linkage portions among the five linkage portions 111 to 115 and 141 to 145. For the left flexible tube linkage 110 and the right flexible tube linkage 140, the orientation of the joints is set symmetrically, thereby achieving the following after unfolding: Figure 2D The 3D shape / structure shown. Design parameters may include the number and length of linkages / frames, the number of joints, the placement of joints, and the rotational constraints of the joints. Rotating elements may be rotary joints. Alternatively, various 3D shapes / structures (e.g., pyramidal shapes) can be formed through different combinations of design parameters. Alternatively, each of the flexible linkage portions 111 to 115, 141 to 145 may be multiple linkage portions.

[0056] Reference Figure 4A and Figure 4BThe diagram illustrates an actuation and locking mechanism 200, which, according to this embodiment, comprises three parts: an actuation base 210, an actuation rod 220, and a locking cap 230. The actuation base 210 includes a window 215 positioned around its distal end, and a recess 211 located on the outer surface of the actuation base 210 adjacent to the window 215, wherein an actuation line 180 is arranged to pass through the window 215 and the recess 211. The actuation base 210 also includes a ridge 212 positioned around its proximal end on its outer surface, the ridge 212 being arranged to serve as a guide for the locking cap 230. The actuation base 210 also includes a threaded hole 213 positioned approximately proximal to the actuation base, and a distal hole 214 positioned approximately at the opposite end of the threaded hole 213, the threaded hole 213 being arranged to receive the actuation rod 220, and the distal hole 214 being arranged to engage the flexible main structure 100.

[0057] The actuator 220 includes a threaded portion 221 positioned around the outer surface of its distal end, the threaded portion 221 being arranged to fit into a threaded hole 213. The actuator 220 also includes a protruding locking key 222 positioned adjacent to the threaded portion 221. A hollow tube 225 is located on the inner surface of the actuator 202, the hollow tube 225 being arranged to provide a passage for the tissue blocking line 181. An L-shaped hook hole 223 and a U-shaped hook loop 224 are positioned at the proximal end of the actuator 220, arranged to connect with the lever 400.

[0058] The locking cap 230 includes a slot 231 located at its distal end, the slot 231 being arranged to slide into a ridge 212 of the actuation base 210. A male connector 232 is located on the outer surface near the proximal end of the locking cap 230, the male connector 232 being arranged to engage a corresponding female connector 330 on the operating tube 300. The locking cap 230 also includes a keyway 233 located near its proximal end, the keyway 233 having a plurality of slots, each slot being arranged to engage a locking key 222, such that the actuation and locking mechanism 200 is in a locked position.

[0059] The actuation and locking mechanism 200 according to this embodiment allows the left flexible tube linkage 110 and the right flexible tube linkage 140 to unfold to form a 3D structure, thereby creating an inter-lumen volume in the workspace for visualization and tool / instrument manipulation. According to this embodiment, the actuation and locking mechanism 200 can be operated by a user at the proximal end of a flexible component (e.g., an endoscope) by manipulating the control tube 300 and the control lever 400, as described below. Figure 5The cylindrical handle 310 is located at the proximal end of the control tube 300 and is arranged for operating the control tube 300, wherein the operation includes actuation, torsional, and rotational movements. The control tube 300 includes a flexible control tube 320 extending from the handle 310; a female connector 330 is located at the distal end of the flexible control tube 320 and extends from the flexible control tube 320, and the female connector 330 is sized to adapt to the male connector 232 of the actuation and locking mechanism 200. Figure 4A The control tube 300 is coupled to the joystick 400, wherein the joystick 400 includes a lever handle 410 located at its proximal end for operating the device. A long flexible rod 420 extends from the lever handle 410 and protrudes through the control tube 300. An L-shaped hook 430 is located on the protruding end of the long flexible rod 420, wherein the L-shaped hook 430 protrudes from the control tube 300. Alternatively, a U-shaped hook 440 may be located on the flexible rod 420 and protrude from the control tube 300. Alternatively, hooks of other shapes (e.g., hooks of other letter shapes) may be located on the flexible rod 420. Alternatively, the handle 310 may be circular instead of cylindrical, or may be any three-dimensional shape to fit the user's hand.

[0060] Figures 6A to 6C The process of connecting the joystick 400 and the control tube 300 to the proximal end of the actuation and locking mechanism 200 according to this embodiment is shown to prepare the delivery device. (Refer to...) Figure 6A The operating tube 300, with an exposed L-shaped hook 430, is positioned near the proximal end of the actuation and locking mechanism 200 and the L-shaped hook hole 223. (See reference...) Figure 6B The L-shaped hook 430 is arranged to fit into the L-shaped hook hole 223, and the operating tube 300 is arranged to slide to contact the proximal end of the actuation and locking mechanism 200, such that the female connector 330 engages with the corresponding male connector 232, placing the operating tube 300 and the actuation and locking mechanism 200 in an engaged configuration. Figure 6C The diagram shows a manipulator 300 in an engaged configuration and an actuation and locking mechanism 200, wherein the device is ready for delivery through the endoscope channel. According to this embodiment, when rotational movement is applied to the manipulator 300 due to rotation of the lever handle 410, the engaged L-shaped hook hole 223 rotates relative to the manipulator 300, thereby causing the actuation and locking mechanism 200 to rotate. This causes the left flexible tube linkage 110, the right flexible tube linkage 140, the side tube frames 170 and 171, and the distal tube frame 172 to unfold and form a 3D unfolded structure, thereby providing a workspace volume.

[0061] Figure 7AA cross-sectional view of the delivery device according to this embodiment is shown. A flexible main structure 100 is adapted to the distal end of an actuation base 210 and can be bonded by adhesive. An actuation line 180 extends from the flexible main structure 100, passes through window 215 to the outside of the actuation base 210, passes through groove 211, and terminates at locking key 222. A tissue blocking line 181 passes internally through actuation rod 220 and terminates at the proximal end of actuation rod 220 having crimp beads 183. The actuation line 180 may require a certain degree of slack to couple the unfolding motion with the tension of the tissue blocking line 181. In this configuration, most of the threaded portion of the actuation rod 220 is located within the threaded hole 213, and the locking key 222 is located away from the keyway 233, thereby ensuring sufficient distance to pull the actuation line 180 and the tissue blocking line 181. Figure 17 Figure B shows an external view of this configuration. Alternatively, the flexible main structure 100 and the actuation base 210 can be connected by corresponding joints or dovetail joints, or by box joints.

[0062] Figure 8A This is a cross-sectional view of the actuation and locking mechanism after the actuation line is pulled, according to this embodiment. Figure 8B This is a cross-sectional view of the device after the actuation line is pulled, according to this embodiment, including a 3D structure forming the volume. A pulling motion is generated by rotating the lever 400 and loosening the actuation rod 220 from the threaded hole 213. The control tube 300 remains stable to generate a counter-torque, thereby preventing the device from rotating. The loosening rotational and linear motion causes the actuation line 180 to wrap around the threaded portion 221, and pulls the tissue blocking line 181 as the proximal end of the actuation rod 220 pushes out the crimping bead 183. The lengths of the threaded hole 213 and the threaded portion 221 need to be determined based on the distance required to pull the actuation line 180 and the tissue blocking line 181 to change the device from a closed, collapsed shape to an unfolded shape (i.e., the lengths of the threaded hole 213 and the threaded portion 221 are linearly related to the pulling distance required to change the device to an unfolded shape). When the lever 400 is pulled toward the control tube 300, the locking key 222 moves closer to the keyway 233, leaving a certain distance between them. Figure 8B An external view of this configuration is shown, in which the flexible main structure 100 forms a tent shape, which ensures the volume of the workspace for endoscopic operations. The relative position of the actuation base 210 and the locking cap 230 does not change before and after actuation (i.e., the groove 231 does not slide along the ridge 212).

[0063] Figure 9AThis is a cross-sectional view of the actuation and locking mechanism 200 according to this embodiment, and a cross-sectional view of a portion of the device after the locking mechanism is actuated. The operating tube 300 is pushed in from its proximal end to slide in the locking cap 230 until the locking key 222 is fitted into a keyway 233, while the operating lever 400 remains stable. Some adjustments to the orientation of the locking cap 230 may be necessary to align the locking key 222 with a keyway 233. Friction is generated between the locking key 222 and the keyway 233 due to the tendency of the actuation line 180 to loosen, and the locking cap 230 is arranged to prevent the unfolded 3D structure from slipping off the actuation base 210. Figure 9B An external view of this state is shown, in which the locking cap 230 is positioned deeper along the ridge 212.

[0064] Figure 10A and Figure 10B An unfolding device according to this embodiment is shown. The left tube linkage 110 forms a portion of the unfolding structure including a front linkage portion 111, a left linkage portion 112, an upper linkage portion 113, a diagonal right linkage portion 114, and a lower linkage portion 115, while the right tube linkage 140 is designed to form a symmetrical portion of the unfolding structure, including a front linkage portion 141, a right linkage portion 142, an upper linkage portion 143, a diagonal left linkage portion 144, and a lower linkage portion 145. The final unfolding structure forms a rectangular box workspace volume for endoscopic operation, wherein the rectangular box workspace volume is a hollow space allowing the endoscope and / or medical device to enter. An actuation line 180 passes through the surface structure (flexible linkage portions 111, 112, 113, 115, 145, 143, 142 and 141, side tube frames 170, 171, and distal tube frame 172) into the interior. Alternatively, the distal tube frame can be a guide tube arranged to provide passage for the actuation line 180. The actuation line 180 is exposed outside the bottom frame at two locations (between flexible linkage portions 112 and 113 and flexible linkage portions 142 and 143). This is to facilitate actuation movement of the connectors 117 and 147 between them. When the actuation line is pulled, the other connectors naturally rotate to their limits. Tissue blocking lines 181 on the lateral and distal sides are associated with multiple flexible tube linkages 110, 140 to prevent surrounding tissue from being compressed into the space or volume formed in the lumen. The proximal and bottom sides remain open for endoscope entry and space for endoscopic manipulation. The lever and tube can be disassembled in the reverse order of the connection process shown in FIG. 6.

[0065] Reference Figure 11AAccording to this embodiment, after the endoscopic operation is completed, a U-shaped hook 440 is introduced into the unfolding structure, wherein the U-shaped hook 440 is arranged to engage one of the exposed actuation lines 180 on the proximal side of the unfolding structure to disconnect the actuation lines 180. (Refer to...) Figure 11B In order to disconnect one of the exposed actuation lines 180, the U-shaped hook rotates on the engaged exposed actuation line, thereby releasing the tension in the actuation line and causing the unfolded structure to collapse, thus advantageously providing a simple and easy means to make the collapsed structure flexible for removal from the lumen.

[0066] Figure 12A and Figure 12B The process of reconnecting the lever 400 and the control tube 300 to the proximal end of the actuation and locking mechanism 200 according to this embodiment is illustrated to prepare for device retraction. The U-hook 440 is hooked by the U-loop 224 to couple the U-hook 440 and the U-loop 224. The control tube 300 then slides to connect the female connector 330 and the male connector 232. The device can then be retracted through the endoscope channel by applying a linear movement to the lever 400, thereby pulling the engaged U-loop 224 and the U-hook 440 and thus pulling the flexible collapse structure through the endoscope channel.

[0067] Reference Figures 13 to 16 A cross-sectional perspective view of the unfolded lumen expansion device according to this embodiment is shown, wherein, Figure 13 A near-side view of the unfolded expansion device is depicted. Figure 14 The image depicts a left-side view of the unfolded expansion device. Figure 15 The right-side view of the unfolded extension device is depicted. Figure 16 A far-side view of the unfolded expansion device is depicted. From Figures 13 to 16As can be seen, the actuation line 180 leaves the actuation and locking mechanism 200 and enters the left inner tube linkage section 111 and the right inner tube linkage section 141. From the left inner tube linkage section 111 and the right inner tube linkage section 141, the actuation line 180 enters the second left tube linkage section 112 and the second right tube linkage section 142 and exits from the holes 121 and 151 located on the second left tube linkage section 112 and the right tube linkage section 142, respectively. The actuation line 180 enters the third left tube linkage section 113 and the third right tube linkage section 143 from the holes 121 and 151 via the holes 122 and 152 located in the lower half of the third left tube linkage section 113 and the third right tube linkage section 143, and exits through the holes 123 and 153 adjacent to the holes 122 and 152, respectively. Then, the actuation line 180 enters the interior of the side tube frames 170 and 171 located at the bottom of the flexible main structure 100. The device travels through side tube frames 170 and 171, through holes 161 and 131 at opposite ends of side frames 170 and 171, into the interior of fifth tube linkage portions 145 and 115 vertically coupled to side frames 170 and 171, and exits through holes 162 and 132 at the bottom of fifth tube linkage portions 145 and 115, and enters the interior of distal tube frame 172 perpendicular to fifth tube linkage portions 145 and 115 from holes 162 and 132 to complete the loop.

[0068] from Figures 13 to 16The view also shows that the tissue blocking line 181 starts from the actuation and locking mechanism 200, passes through the left tube linkage portions 111, 112, and 113, and exits from the hole 124 located on the left tube linkage portion 113. The tissue blocking line 181 passes through the middle of the left side of the flexible main structure 100 from the hole 124, enters the hole 159 on the tube linkage portion 145, and exits from the hole 160 adjacent to the hole 159. The tissue blocking line 181 passes through the middle of the distal side of the flexible main structure 100, enters the hole 130 on the tube linkage portion 115, and exits from the hole 129 adjacent to the hole 130. The tissue blocking line 181 intersects at the middle of the right side of the flexible main structure 100, enters the hole 154 of the tube linkage portion 143, travels upward through the tube linkage portion 143, and exits from the hole 155 located at the top of the tube linkage portion 143. Then, the tissue blocking line 181 passes through the top of the right side of the flexible main structure 100, enters the hole 127 located at the top of the tube linkage portion 115, and exits from the hole 128 adjacent to the hole 127. The tissue blocking line 181 then passes through the top of the distal side of the flexible main structure 100, enters the hole 158, and exits from the hole 157 of the tube linkage portion 115. The tissue blocking line 181 passes through the hole 157 through the top of the left side of the flexible main structure 100, enters the hole 125 of the tube linkage portion 113, exits from the hole 126 adjacent to the hole 125, intersects the top of the proximal side of the flexible main structure 100, enters the tube linkage portion 143 through the hole 155, and returns to the actuation and locking mechanism 200 through the tube linkage portions 143, 142, and 141. Alternatively, the actuation line 180 may be arranged to pass through the interior of the joints between the tube linkage sections 111 and 112 and between 141 and 142. Holes may be formed to allow the actuation line 180 to pass through the exterior of these joints, increasing rotational torque and facilitating deployment. The number and position of the holes 124 to 130 and 154 to 160 on the linkages can be adjusted according to the desired position of the tissue blocking line 181. Additionally, holes may be formed on the side tube frames and bottom tube frames 170, 171, and 172 to allow the tissue blocking line to pass through when the amount of compressed tissue needs to be adjusted.

[0069] Reference Figure 17 and Figure 18The diagram depicts a diagonal cross-sectional view of the left linkage portion 114 and the right linkage portion 144 of the deployed lumen expansion device according to this embodiment. A flexible elastic line 182 passes through the linkage portions 114 and 144 located at the top of the structure and through holes 133 and 163, such that the flexible elastic line 182 is wound around the intersection of the linkage portions 114 and 144, thereby advantageously coupling the left tube linkage 110 and the right tube linkage 140. According to this embodiment, the elasticity of the flexible elastic line 182 advantageously allows for limiting the relative positions of the linkage portions 114 and 144 of the left tube linkage 110 and the right tube linkage 140, thereby giving the deployed 3D structure greater stability and durability.

[0070] Reference Figure 19 When the device is fully deployed, the actuation line 180 forms the shape of the basic structure that forms the 3D deployment structure, thereby advantageously pulling the flexible linkages 110 and 140 into their deployed position according to this embodiment. (Refer to...) Figure 20 The tissue barrier line 181 terminates at the crimping bead 183, and according to this embodiment, a loop is formed to create the left, right, and distal sides of the top structure and the unfolding structure that intersect and open, thereby advantageously reducing tissue intrusion into the unfolding structure. (Refer to...) Figure 21 According to this embodiment, the actuation line 180 and the tissue blocking line 181 are shown together, showing that they overlap each other.

[0071] Figure 22 The flexible main structure 100 (left tube linkage 110, right tube linkage 140, and side tube frames 170, 171, 172) in a 3D configuration in the absence of actuation line 180 and tissue blocking line 181, according to this embodiment, is shown. Figure 23 This illustration shows a device with an actuation line 80 and a tissue barrier line 181 according to this embodiment. Figure 22 The unfolded 3D configuration, wherein the actuation line has been rotated to pull the flexible master structure 100 into the unfolded 3D configuration, and the crimping bead 183 has been pulled away from the unfolded structure to pull the tissue blocking line 181 into place. (Refer to...) Figure 24 , Figure 23 The unfolded 3D structure, actuation line 180, and tissue blocking line 181 shown are together with the actuation base 210 and actuation rod 220 for unfolding the flexible main structure according to this embodiment.

[0072] Reference Figure 25A and Figure 25B This describes a variation of the #D structure developed according to this embodiment. From Figure 25A and 25BAs can be seen in the photograph, the unfolding structure has a small distal side and a large proximal side with rounded connecting edges. The lengths of the linkage portions 111 to 115 and 141 to 145 are arranged to form a structure with a small distal side and a large proximal side. The small distal side advantageously reduces the risk of actuation wire tangling during unfolding and the risk of the structure's tips getting stuck in tissue. Furthermore, due to the large proximal side, the unfolding structure can be strategically anchored by pressing outwards into the surrounding body cavities. Additionally, the joints 117, 118, 147, and 148 on the proximal side can preferably be rounded by forming multiple slots to prevent the risk of sharp edges damaging tissue in adjacent working spaces. Furthermore, according to this embodiment, the actuation wire 180 can be arranged outside the linkage portions 111, 112 and 141, 142 to advantageously increase the torque on the rotary joints 116 and 146, thereby facilitating unfolding. Figure 25A and Figure 25B The possible arrangement of tissue barrier lines 181 on the bottom surface of the unfolded 3D structure is also shown.

[0073] Figures 26A to 26C Another embodiment of the present invention is shown for connecting the locking cap 230 to the operating tube 300. After the locking cap 230 is linearly engaged with the operating tube 300, the operating tube 300 can be rotated to adapt an L-shaped socket to the locking cap 230 and the operating tube 331 to prevent the operating tube 300 from accidentally disconnecting from the locking cap 230 during operation of the device.

[0074] Reference Figure 27A This illustration depicts another embodiment of the actuation base and locking cap according to this embodiment, wherein the locking cap 230 engages with the actuation base 210. According to this embodiment, the actuation base 210 includes a ridge 216 on its proximal end, and the locking cap 230 includes a corresponding groove 235. The ridge 216 has protruding portions, and each protruding portion is sized to fit into the corresponding groove 235. The corresponding groove 235 is surrounded by two horizontal edges and two vertical edges forming a rectangular shape, and each groove has a channel formed by the vertical edges, thereby allowing the protruding portions to slide vertically along the channel.

[0075] Reference Figure 27B , Figure 27A The embodiments also depict the locking cap 230 being moved rearward so that the ridge 216 contacts one of the horizontal edges of the groove 235, thereby advantageously preventing the locking cap 230 from slipping off the actuation base 210.

[0076] Figures 28A to 28CThe steps of an alternative method for the reconnection process of FIG12 according to this embodiment are shown, wherein magnetic attraction is used to prepare for device retraction. According to this method, permanent magnet 226 may be attached to the proximal end of actuation and locking mechanism 200 instead of a U-shaped hook. Additionally, a corresponding permanent magnet 450 may be attached to the end of lever 400, wherein permanent magnet 226 and the corresponding permanent magnet 450 are at different magnetic poles, such that permanent magnets 226 and 450 attract each other. In this way, magnetic attraction can be advantageously used to properly orient and engage actuation and locking mechanism 200 and lever 400 for device retraction and removal.

[0077] Figures 29A to 29C Another embodiment of the actuation and locking mechanism, a variation of this embodiment, is shown. The actuation and locking mechanism includes an L-shaped socket actuation base 240 and a T-shaped lock 250. Delivery and actuation are provided by a lever 400 and an external actuation tube 340. The female connector of the lever 460 is connected to the male connector of the T-shaped lock 252, while the tension line 470 facilitates pulling the actuation line 180 for in-situ deployment of the 3D structure. Additionally, the female connector of the external actuation tube 341 is connected to the male connector of the L-shaped socket actuation base 245. The actuation line 180 enters through a central hole 241, exits through a window 242, passes through external wiring of a channel 243, and enters internally through the L-shaped socket 244. The actuation line then passes through a hole 251 in the T-shaped lock 250.

[0078] Figures 30A to 30D It shows Figures 29A to 29C The steps in the tensioning, locking, and disengagement process of a variation of the actuation and locking mechanism. (Refer to...) Figure 30A Pull the tension line 470° to tension the moving line 180°. Figure 30B Then, the actuator cable 180 is twisted by rotating the lever 400. The twisted actuator cable 180 provides friction to maintain the applied tension. (See next...) Figure 30C The T-lock 250 is inserted into the L-shaped socket 244 to prevent the actuation wire 180 from unwinding, wherein the T-lock 250 is coupled to the lever 400. Then, Figure 30D In the middle, the lever 400 is pulled and retracted, causing the T-lock 250 to be inserted into the L-shaped socket 244. Then, the rotation of the device is advantageously prevented by the external operating tube 340 engaged with the L-shaped socket actuation base 240.

[0079] Alternatively, the manipulator can be of any form, as long as the flexible main structure 100 and the actuation and locking mechanisms are manipulated as intended. For example, the manipulator may consist of a flexible tube and rod having a socket, slot, or hook at its distal end.

[0080] This embodiment advantageously provides an apparatus and method for expanding a body lumen or a flexible, collapsible catheter to expose and maintain a working space, such as forming a volume within the lateral wall tissue of the lumen for endoscopic diagnosis, treatment, and surgery without relying on airflow. Furthermore, the apparatus can be attached to a conventional endoscope without increasing its size or the perforations used. Additionally, the apparatus and method according to this embodiment provide an expanded and stable intraluminal space for proper visualization of the target region (e.g., target tissue) and surrounding lateral walls, and form a volume within a flexible, collapsible catheter for a suitable working space, thereby independently manipulating delivery mechanisms (e.g., endoscopes or catheters or similar flexible components) and tools or other instruments.

[0081] While exemplary embodiments have been presented in the foregoing detailed description of these embodiments, it should be understood that numerous variations exist. It should also be understood that the exemplary embodiments are merely examples and are not intended to limit the scope, applicability, operation, or configuration of the invention in any way. Rather, the foregoing detailed description provides those skilled in the art with a convenient roadmap for implementing the exemplary embodiments of the invention, and it should be understood that various changes can be made to the functionality and arrangement of the steps described in the exemplary embodiments and the methods of operation without departing from the scope of the invention as set forth in the appended claims.

Claims

1. A device for providing a three-dimensional volume in a workspace within a body lumen, the device comprising: Multiple flexible tube linkages, each of which has a distal end and a proximal end; as well as An actuation and locking mechanism includes an actuation line, an actuation base having a threaded hole, an actuation rod having a threaded portion and a locking key, the threaded portion being arranged to engage the threaded hole, and a locking cap having a keyway being arranged to engage the locking key, so as to place the actuation and locking mechanism in a locked position. In this embodiment, the proximal end of each of the plurality of flexible tube linkages is coupled to the actuation and locking mechanism. Wherein, the distal end of the actuation line is connected to the distal end of each of the plurality of flexible tube linkages, and The actuation and locking mechanism is arranged to rotate relative to the plurality of flexible tube linkages to pull the distal end of the actuation line toward the actuation and locking mechanism, thereby moving the distal end of each flexible tube linkage toward the proximal end of each flexible tube linkage, thereby transforming the plurality of flexible tube linkages from a closed, collapsed structure for transport to the workspace into a three-dimensional structure defined by the plurality of flexible tube linkages, thereby defining a three-dimensional volume in the workspace within the body cavity.

2. The apparatus according to claim 1, wherein, The actuation and locking mechanism also includes a structural wire that, when forming the defined structure, is vertically connected to the plurality of flexible tube linkages.

3. The apparatus according to claim 2, wherein, When the actuation and locking mechanism rotates, the tension in the structural filament increases, thereby providing rigidity to the three-dimensional structure defined by the flexible tube linkage.

4. The apparatus according to claim 1, wherein, The actuation and locking mechanism includes a guide tube arranged to provide a channel for the actuation line.

5. The apparatus according to claim 1, wherein, The device further includes a distal tube coupled to at least one of the plurality of flexible tube linkages, wherein the actuation line is arranged to pass through the distal tube.

6. The apparatus according to claim 2, wherein, The structural wire is arranged to pass through the actuating rod, and the actuation line is arranged to pass through the outer surface of the actuation base.

7. The apparatus of claim 1 further comprises one or more tissue blocking lines, said one or more tissue blocking lines being arranged in association with said plurality of flexible tube linkages to prevent surrounding tissue at the target site from entering the defined three-dimensional volume of the body lumen.

8. The apparatus of claim 1 further includes an operating tube having a lever, the lever including a hook arranged to engage the actuation and locking mechanism.

9. The apparatus according to claim 8, wherein, The joystick is configured to rotate the actuation and locking mechanism.

10. The apparatus according to claim 1, wherein, Each of the plurality of flexible tube linkages includes a plurality of linkage parts and a rotating element, wherein each rotating element connects adjacent linkage parts among the plurality of linkage parts.

11. The apparatus according to claim 1, wherein, The device is configured to define a three-dimensional volume within the body lumen for endoscopic manipulation, wherein the defined three-dimensional volume is a cuboid volume arranged to allow the endoscope to pass through.

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