Dynamically rigid composite medical structure

Abstract

The invention relates to a dynamically rigidified composite medical structure. A rigidifying device includes a plurality of layers and an inlet between an elongate flexible tube and an outer layer and configured to attach to a vacuum or pressure source. The stiffening device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet and a flexible configuration when no vacuum or pressure is applied through the inlet.

Description

[0001] This application is a divisional application of the invention patent application filed on January 16, 2020, with application number 202080041970.X and invention title "Dynamic Rigid Composite Medical Structure". Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 835,101, filed April 17, 2019, entitled “DYNAMICALLY RIGIDIZING COMPOSITEMEDICAL STRUCTURES”, and U.S. Provisional Application No. 62 / 854,199, filed May 29, 2019, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”, the entire contents of which are incorporated herein by reference. This application may also relate to international application PCT / US2019 / 042650, filed July 19, 2019, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” which takes precedence over U.S. Provisional Application 62 / 835,101, filed April 17, 2019, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” U.S. Provisional Application 62 / 854,199, filed May 29, 2019, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” and U.S. Provisional Application 62 / 854,199, filed December 17, 2018, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES.” The contents of U.S. Provisional Application No. 62 / 780,820 entitled “MEDICALSTRUCTURES” and U.S. Provisional Patent Application No. 62 / 700,760 entitled “BRAIDEDDYNAMICALLY RIGIDIZING OVERTUBE”, filed on July 19, 2018, are incorporated herein by reference.

[0003] This application may also relate to international patent application PCT / US2018 / 042946, filed July 19, 2018, entitled “DYNAMICALLY RIGIDIZING OVERTUBE.” This international patent application claims priority to the following U.S. provisional patent applications: U.S. Provisional Patent Application 62 / 672,444, filed May 16, 2018, entitled “DYNAMICALLY RIGIDIZING OVERTUBE,” and U.S. Provisional Patent Application 62 / 535,134, filed July 20, 2017, entitled “DYNAMICALLY RIGIDIZING OVERTUBE.” The contents of these patent applications are incorporated herein by reference.

[0004] This application may also relate to U.S. Patent Application 15 / 757,230, filed March 2, 2018, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” now U.S. Patent Application Publication No. US2018 / 0271354, which is a national phase application pursuant to 35 USC 371, filed September 2, 2016, entitled PCT / US2016 / 050290, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE.” This international application claims priority to the following provisional patent applications: U.S. Provisional Application 62,339,593, filed May 20, 2016, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” and U.S. Provisional Application 62,339,593, filed September 3, 2015, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE.” U.S. Provisional Application 62 / 213,908, entitled “ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE”, the contents of which are incorporated herein by reference.

[0005] By invoking All publications and patent applications mentioned in this specification are incorporated herein by reference to the same extent as each individual publication or patent application is specifically and individually indicated by reference. Background Technology

[0006] In medical procedures, interventional medical devices may bend or loop through anatomical structures, making the advancement of the medical device difficult.

[0007] Gastrointestinal loops, a well-known clinical challenge in endoscopy, occur when the endoscope becomes impassable due to excessive tortuosity or looping in the gastrointestinal tract. In fact, one study found that 91 out of 100 patients undergoing colonoscopy developed loops [Shah et al., “Magnetic Imaging of Colonoscopy: An Audit of Looping, Accuracy and Ancillary maneuvers.” Gastrointest Endosc 2000; 52: 1-8]. Gastrointestinal loops prolong procedure time and can cause patient pain as they stretch blood vessel walls and the mesentery. Furthermore, gastrointestinal loops increase the incidence of gastrointestinal perforation. In cases of severe gastrointestinal loops, a complete colonoscopy is impossible because the loops stretch the length of the colon, preventing the colonoscope from reaching the distal end. Gastrointestinal loops also hinder precise control of the tip, preventing the user from achieving the ideal one-to-one correspondence between the handle and the endoscope tip. Such problems commonly occur during a wide range of endoscopic procedures, including colonoscopy, esophagogastric-duodenal endoscopy (EGD), enteroscopy, endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopy (including ESD (endoscopic submucosal dissection) and EMR (endoscopic mucosal resection)), robotic flexible endoscopy, transoral robotic surgery (TORS), anatomically modified cases (including Roux-en-Y), and NOTES (natural orifice endoscopic surgery). Therefore, a device is needed to help prevent gastrointestinal loops, providing a more successful route of access to the gastrointestinal tract.

[0008] Similar difficulties arise when advancing medical devices, such as during interventional surgeries in the lungs, kidneys, brain, heart, and other anatomical locations. Therefore, a device is needed that can safely, efficiently, and precisely access difficult-to-reach anatomical locations. Summary of the Invention

[0009] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer above the elongated flexible tube, an outer layer above the flexible tube and the braided layer, and an inlet located between the flexible tube and the outer layer and attached to a vacuum or pressure source. The braided layer has multiple strands of yarn woven together, with a braiding angle of 5-40 degrees relative to the longitudinal axis of the elongated flexible tube when it is straight. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet. The braiding angle is configured to vary as the rigidification device bends when it is in a flexible state.

[0010] This embodiment and other embodiments of the invention may include one or more of the following features: The braiding angle may be between 10 and 35 degrees. The braiding angle may be between 15 and 25 degrees. The stiffness of the rigidification device in a rigid configuration may be at least twice that of the rigidification device in a flexible configuration. The stiffness of the rigidification device in a rigid configuration may be at least five times that of the rigidification device in a flexible configuration. The rigidification device may also include a sliding layer adjacent to the braided layer, and the sliding layer has a lower coefficient of friction than the braided layer. The elongated flexible tube may include reinforcing elements extending therein. The reinforcing elements may include coils or multiple annular elements. The multi-strand wire may be braided together with 4-60 strands per inch. The strands may include polyethylene terephthalate or stainless steel. The braided layer may provide 30-70% coverage relative to the elongated flexible tube. The multi-strand wire may include 96 or more strands. The inlet may be configured to connect to a pressure source, and the rigidification device may further include a bladder layer. The bladder layer may be configured to be pushed against the braided layer when pressure is applied through the inlet. The outer layer may further include multiple reinforcing elements. The inlet may be configured to connect to a vacuum source, and the outer layer may be a thin, flexible sheath. The rigidification device may further include a radial gap between the braided layer and the outer layer, the gap thickness being 0.00002-0.04 inches. The rigidification device may further include a steerable distal end. The rigidification device may include a sealed channel between the elongated flexible tube and the outer layer. The sealed channel may include a working channel, a cable guide, or an inflation chamber.

[0011] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer, the braided layer having multiple strands braided together with a braiding angle of 5-40 degrees relative to the longitudinal axis when the elongated flexible tube is straight, wherein the braiding angle is configured to vary as the rigidification device bends when it is in a flexible configuration; and (2) when the rigidification device has reached a desired position in the body cavity, converting the rigidification device into a rigid configuration that is harder than the flexible configuration by activating a vacuum or pressure between the flexible tube and the outer layer.

[0012] This embodiment and other embodiments of the invention may include one or more of the following features. The method may further include releasing the vacuum or pressure after activating the vacuum or pressure to transform the rigid configuration back into a flexible configuration. The weaving angle may be between 10 degrees and 35 degrees. The weaving angle may be between 15 degrees and 25 degrees. The method may also include passing a mirror through the rigidification device while the rigidification device is in a rigid configuration. The method may further include turning the steerable distal end of the rigidification device through a body cavity. The body cavity may be in the gastrointestinal tract. The body cavity may be in the heart. The body cavity may be in the kidney. The body cavity may be in the lung. The body cavity may be in the brain.

[0013] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer above the elongated flexible tube, an outer layer above the flexible tube and the braided layer, and an inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet. The ratio of the stiffness of the rigidification device in the rigid configuration to the stiffness of the rigidification device in the flexible configuration is greater than 5.

[0014] This embodiment and other embodiments of the invention may include one or more of the following features. The ratio described above may be greater than 6. The ratio may be greater than 10. The braided layer may have multiple strands braided together, with a braid angle of 5-40 degrees relative to the longitudinal axis when the elongated flexible tube is straight. The braid angle may be between 10 degrees and 35 degrees. The rigidification device may also include a sliding layer adjacent to the braided layer, and the sliding layer has a lower coefficient of friction than the braided layer. The elongated flexible tube may include reinforcing elements extending therein. The reinforcing elements may include coils or multiple annular elements. The braided layer may include multiple strands braided together at 4-60 strands per inch. The braided layer may include multiple strands braided together, and the strands may include polyethylene terephthalate or stainless steel. The braided layer may provide 30-70% coverage relative to the elongated flexible tube. The braided layer may include 96 or more strands braided together. The inlet may be configured to connect to a pressure source. The rigidification device may further include a bladder layer, which may be configured to be pushed against the braided layer when pressure is applied through the inlet. The outer layer may further include multiple reinforcing elements. The inlet can be configured to attach to a vacuum source. The outer layer can be a thin, flexible sheath. The rigidification device can further include a radial gap between the braided layer and the outer layer. The thickness of the gap can be 0.00002-0.04 inches. The rigidification device can further include a steerable distal end. The rigidification device can further include a sealed channel between the elongated flexible tube and the outer layer. The sealed channel can include a working channel, a cable guide, or an inflation chamber.

[0015] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer; and (2) when the rigidification device has reached a desired position in the body cavity, converting the rigidification device into a rigid configuration that is stiffer than the flexible configuration by activating a vacuum or pressure between the flexible tube and the outer layer. The ratio of the stiffness of the rigidification device in the rigid configuration to the stiffness of the rigidification device in the flexible configuration is greater than 5.

[0016] This embodiment and other embodiments of the invention may include one or more of the following features. The method may further include converting a rigid configuration back to a flexible configuration by releasing a vacuum or pressure after activation. The ratio may be greater than 6. The ratio may be greater than 10. The method may further include allowing a mirror to pass through the rigidification device while the rigidification device is in a rigid configuration. The method may further include turning the steerable distal end of the rigidification device through a body cavity. The body cavity may be in the gastrointestinal tract. The body cavity may be in the heart. The body cavity may be in the kidney. The body cavity may be in the lung. The body cavity may be in the brain.

[0017] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer located radially outside the elongated flexible tube, a sliding layer adjacent to the braided layer, an outer layer, and a vacuum or pressure inlet between the elongated flexible tube and the outer layer. The outer layer is located above the flexible tube, the braided layer, and the sliding layer. The inlet is configured to attach to a vacuum or pressure source. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet. The sliding layer is configured to reduce friction between the braided layer and the elongated flexible tube or between the braided layer and the outer layer when the rigidification device is in the flexible configuration.

[0018] This embodiment and other embodiments of the invention may include one or more of the following features: The sliding layer may have a lower coefficient of friction than the braided layer. The sliding layer may include powder. The stiffness of the rigidification device in the rigid configuration is at least twice that in its flexible configuration. The stiffness of the rigidification device in the rigid configuration is at least five times that in its flexible configuration. The braided layer may have multiple strands braided together, with a braid angle of 5-40 degrees relative to the longitudinal axis when the elongated flexible tube is straight. The braid angle may be between 10 degrees and 35 degrees. The elongated flexible tube may include reinforcing elements extending therein. The reinforcing elements may include coils or multiple annular elements. The braided layer may include multiple strands braided together at 4-60 strands per inch. The braided layer may include multiple strands braided together, and the strands may include polyethylene terephthalate or stainless steel. The braided layer may provide 30-70% coverage relative to the elongated flexible tube. The braided layer may include 96 or more strands braided together. The inlet may be configured to attach to a pressure source. The rigidification device may further include a bladder layer. The bladder layer may be configured to be pushed toward the braided layer when pressure is applied through the inlet. The outer layer may further include multiple reinforcing elements. The inlet may be configured to attach to a vacuum source. The outer layer may be a thin, flexible sheath. The rigidification device may further include a radial gap between the braided layer and the outer layer. The gap thickness may be 0.00002-0.04 inches. The rigidification device may further include a steerable distal end. The rigidification device may further include a sealed channel located between the elongated flexible tube and the outer layer. The sealed channel may include a working channel, a cable guide, or an inflation chamber.

[0019] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, a sliding layer adjacent to the braided layer, and an outer layer, wherein when the rigidification device is in a flexible configuration, the sliding layer reduces friction between the braided layer and the elongated flexible tube or between the braided layer and the outer layer; and (2) when the rigidification device has reached a desired position in the body cavity, activating a vacuum or pressure between the flexible tube and the sheath to transform the rigidification device into a rigid configuration that is harder than the flexible configuration state.

[0020] This embodiment and other embodiments of the invention may include one or more of the following features. The method may further include releasing the vacuum or pressure after activating the vacuum or pressure to convert the rigid configuration back to a flexible configuration. The sliding layer may have a lower coefficient of friction than the braided layer. The sliding layer may include powder. The method may further include passing a mirror through the rigidification device while the rigidification device is in a rigid configuration. The method may further include turning the steerable distal end of the rigidification device through a body cavity. The body cavity may be in the gastrointestinal tract. The body cavity may be in the heart. The body cavity may be in the kidney. The body cavity may be in the lung. The body cavity may be in the brain.

[0021] Typically, in one embodiment, the rigidification device includes an inner elongated flexible tube having a reinforcing element and a matrix, a braided layer located radially outside the elongated flexible tube, an outer layer above the braided layer, and a vacuum or pressure inlet located between the elongated flexible tube and the outer layer, the vacuum or pressure inlet being configured to attach to a vacuum or pressure source. The aspect ratio of the reinforcing element to its thickness exceeds 5:1. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0022] This embodiment and other embodiments of the invention may include one or more of the following features: The reinforcing element may be a coil. The reinforcing element may include multiple closed loops. The closed loops may include multiple pockets or notches. The reinforcing element may include a wavy line. The reinforcing element may be fiber or wire. The aspect ratio of the reinforcing element may exceed 10:1. The aspect ratio may exceed 11:1. Multiple reinforcing elements may be present in the elongated flexible tube, with a spacing of 0.0006 inches or less between each reinforcing element. The elongated flexible tube may further include a matrix in which the reinforcing elements are embedded. The matrix may include TPU or TPE.

[0023] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, the rigidification device comprising: an elongated flexible tube having a reinforcing element and a matrix, a braided layer and an outer layer, wherein the aspect ratio of the width to the thickness of the reinforcing element is greater than 10:1; and (2) activating a vacuum or pressure between the flexible tube and the outer layer when the rigidification device has reached a desired position in the body cavity to transform the rigidification device into a rigid configuration that is harder than the flexible configuration.

[0024] This embodiment and other embodiments of the present invention may include one or more of the following features: the slender, flexible tube can resist compression when a vacuum or pressure is applied.

[0025] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer above the elongated flexible tube, an outer layer above the flexible tube and the braided layer, and an inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The braided layer has multiple strands of yarn woven together. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet. The ends of the strands are embedded in or surrounded by annular rings, such that the annular rings allow relative movement of the ends when the rigidification device is in the flexible configuration.

[0026] This embodiment and other embodiments of the invention may include one or more of the following features: The annular ring may include a material coating. The annular ring may contain silicone or urethane. The thickness of the annular ring is approximately 0.005-0.250 inches.

[0027] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer having multiple strands woven together, and an outer layer; and (2) activating a vacuum or pressure between the flexible tube and the sheath when the rigidification device has reached a desired position in the body cavity to transform the rigidification device into a rigid configuration that is stiffer than the flexible configuration. The ends of the strands are embedded in or surrounded by annular rings, such that the ends move relative to each other when the rigidification device is in a flexible configuration. When the rigidification device is in a rigid configuration, the ends are substantially fixed relative to each other.

[0028] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer over the elongated flexible tube, an outer layer sealed over the flexible tube and the braided layer, and an inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The braided layer has multiple strands woven together and multiple circumferential fibers woven within the braided layer. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0029] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer; and (2) activating a vacuum between the flexible tube and the outer layer when the rigidification device has reached a desired position in the body cavity, to transform the rigidification device into a rigid configuration that is stiffer than the flexible configuration. The braided layer includes multiple strands of yarn woven together and a plurality of circumferential fibers woven in the braided layer.

[0030] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a bladder layer above the elongated flexible tube, a braided layer above the bladder layer, an outer layer above the flexible tube and the braided layer, a pressure inlet between the bladder layer and the elongated flexible tube, and a vent outlet between the bladder layer and the outer layer. The pressure inlet is configured to connect to a pressure source. The braided layer comprises multiple strands braided together. The rigidification device is configured to achieve a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet. When the rigidification device transitions from a flexible configuration to a rigid configuration, fluid or gas around the strands is discharged through the vent outlet.

[0031] This embodiment and other embodiments of the invention may include one or more of the following features. The rigidification device may also include a handle connected to an elongated flexible tube. The handle may include a vent port communicating with the vent outlet.

[0032] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a bladder layer, a braided layer having multiple strands woven together, and an outer layer; and (2) when the rigidification device has reached a desired position in the body cavity, providing pressure through an inlet between the elongated flexible tube and the bladder layer, and discharging gas or fluid around the strands through a vent outlet to transform the rigidification device into a rigid configuration that is harder than the flexible configuration.

[0033] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer over the elongated flexible tube, an outer layer over the flexible tube and the braided layer, a channel extending between the outer layer and the elongated flexible tube, and an inlet. The inlet is located between the elongated flexible tube and the outer layer and is configured to be attached to a vacuum source or a pressure source. The channel includes a working channel, a steering cable channel, or an inflation chamber. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0034] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer; (2) activating a vacuum or pressure between the flexible tube and the outer layer when the rigidification device has reached a desired position in the body cavity to transform the rigidification device into a rigid configuration that is harder than the flexible configuration; and (3) allowing a medical instrument to pass through a sealed working channel located between the elongated flexible tube and the outer layer.

[0035] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer; (2) activating a vacuum or pressure between the flexible tube and the outer layer when the rigidification device has reached a desired position in the body cavity to transform the rigidification device into a rigid configuration that is stiffer than the flexible configuration; and (3) activating at least one cable located between the elongated flexible tube and the outer layer to orient the distal end of the rigidification device.

[0036] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer; (2) activating a vacuum or pressure between the flexible tube and the outer layer when the rigidification device has reached a desired position in the body cavity to transform the rigidification device into a rigid configuration that is harder than the flexible configuration; and (3) inflating an airbag on the rigidification device by passing an inflation medium through a sealed inflation cavity located between the elongated flexible tube and the outer layer.

[0037] Typically, in one embodiment, the rigidification device includes an elongated flexible tube having a central cavity, a braided layer above the elongated flexible tube, an outer layer above the flexible tube and the braided layer, a plurality of sealed working channels extending in the central cavity, and an inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0038] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting the rigidification device into the body cavity while it is in a flexible configuration, wherein the rigidification device includes an elongated flexible tube, a braided layer, and an outer layer; (2) activating a vacuum or pressure between the flexible tube and the outer layer when the rigidification device has reached a desired position in the body cavity to transform the rigidification device into a rigid configuration that is harder than the flexible configuration; (3) passing a first medical instrument through a first sealed working channel of the rigidification device; and (4) passing a second medical instrument through a second sealed working channel of the rigidification device.

[0039] Typically, in one embodiment, the external catheter includes an elongated tube and a distal tip attached to the elongated tube. The distal tip has an annular distal facet with one or more vacuum orifices extending therethrough. The one or more vacuum orifices are configured to aspirate tissue toward the annular distal facet when a vacuum is applied therethrough.

[0040] This embodiment and other embodiments of the invention may include one or more of the following features: The elongated tube may be a rigidification device, and the rigidification device may be configured to have a rigid configuration when a vacuum or pressure is applied to its walls, and a flexible configuration when no vacuum or pressure is applied to its walls. The elongated tube may include a braided layer and an outer layer located above the braided layer. The annular distal end face may be angled relative to the longitudinal axis of the elongated tube.

[0041] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer on top of the elongated flexible tube, an outer layer on top of the flexible tube and the braided layer, and a distal tip connected to the elongated flexible tube. The braided layer has multiple strands braided together at a first braid angle, which is relative to the longitudinal axis of the elongated flexible tube when it is straight. The distal tip includes a second braided layer having multiple strands braided together at a second braid angle, which is different from the first braid angle. The inlet between the elongated flexible tube and the outer layer is configured to be attached to a vacuum source or a pressure source. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0042] This embodiment and other embodiments of the present invention may include one or more of the following features: The second knitting angle may be greater than the first knitting angle. The first knitting layer and the second knitting layer may be combined with each other.

[0043] Typically, in one embodiment, the rigidification device includes an elongated flexible tube comprising a plurality of reinforcing elements. The elongated flexible tube includes a proximal portion and a distal portion. A braided layer is located on the proximal portion, not the distal portion. The braided layer has multiple strands braided together at a first braid angle relative to the longitudinal axis of the elongated flexible tube when it is straight. Above the braided layer is an outer layer. A plurality of steerable linkages extend on the distal portion, not the proximal portion. An inlet between the elongated flexible tube and the outer layer is configured to be attached to a vacuum source or a pressure source. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0044] This embodiment and other embodiments of the invention may include one or more of the following features. The rigidification device may further include multiple cables connected to the steerable linkage. The cables may extend between an elongated flexible tube and an outer layer.

[0045] Typically, in one embodiment, the rigidification device includes a rigidification component and a plurality of linkages. The rigidification component includes an elongated flexible tube, a braided layer above the elongated flexible tube, an outer layer above the flexible tube and the braided layer, and an inlet. The inlet is located between the elongated flexible tube and the outer layer and is configured to attach to a vacuum source or pressure source. A plurality of steering linkages are mounted on the distal portion of the rigidification component. The rigidification component is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0046] This embodiment and other embodiments of the invention may include one or more of the following features. The rigidification device may further include multiple cables connected to the steerable linkage. The cables may extend between an elongated flexible tube and an outer layer.

[0047] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a plurality of steerable linkages, and an outlet. The elongated flexible tube includes a proximal portion and a distal portion. The elongated flexible tube includes: a plurality of reinforcing elements, a braided layer located above the distal and proximal portions, and an outer layer having the plurality of reinforcing elements. The plurality of steerable linkages extend on the distal portion, not the proximal portion. An inlet is located between the elongated flexible tube and the outer layer and is configured to be attached to a vacuum source or pressure source. The braided layer has multiple strands braided together at a first braid angle relative to the longitudinal axis of the elongated flexible tube when it is straight. The outer layer is located on the proximal portion, not the distal portion. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0048] This embodiment and other embodiments of the invention may include one or more of the following features. The rigidification device may further include multiple cables connected to the steerable linkage. The cables may extend between an elongated flexible tube and an outer layer.

[0049] Typically, in one embodiment, the rigidification device includes a rigidification component and a plurality of linkages. The rigidification component includes an elongated flexible tube, a braided layer above the elongated flexible tube, an outer layer above the flexible tube and the braided layer, and an inlet located between the elongated flexible tube and the outer layer and configured to attach to a vacuum source or pressure source. A ridge extends through a distal portion of the rigidification component. The ridge is configured to bend the rigidification component in a predetermined direction. A plurality of steering linkages are located distal to the rigidification component. The rigidification component is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0050] This embodiment and other embodiments of the invention may include one or more of the following features. The rigidification device may also include a wire, configured to bend the device at a ridge when activated. The rigidification device may further include multiple cables connected to a steerable linkage. The cables may extend between an elongated flexible tube and an outer layer.

[0051] Typically, in one embodiment, the rigidification device includes a rigidification component and a distal tip. The rigidification component includes: an elongated flexible tube; a braided layer over the elongated flexible tube; an outer layer over the flexible tube and the braided layer; and an inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The distal tip is attached to the elongated flexible tube. The distal tip includes a plurality of linkages connected together at a pivot point. The rigidification component and the distal tip are configured to exhibit a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0052] Typically, in one embodiment, a handle for use with a rigidification device includes: a handle body configured to be attached to the rigidification device; a vacuum feed line attached to the handle body configured to be connected to a vacuum source; a vacuum port in communication with a wall of the rigidification device; and an activation element on the handle body. The activation element is configured to move between a first position and a second position. In the first position, the activation element connects the vacuum feed line to the vacuum port to provide a vacuum to the wall of the rigidification device, while in the second position, the activation element disconnects the vacuum feed line from the vacuum port to allow ventilation of the wall of the rigidification device.

[0053] This embodiment and other embodiments of the invention may include one or more of the following features: The activation element may include a magnetic element thereon. The magnetic element may be configured to hold the activation element in a first position or a second position. The vacuum feed line may be coiled inside the handle.

[0054] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) holding the handle of the rigidification device; (2) inserting the elongated body of the rigidification device into the body cavity while the rigidification device is in a flexible configuration; (3) when the rigidification device has reached the desired position in the body cavity, moving an activation element in a first direction to connect the vacuum feed line and vacuum port of the handle to the wall of the elongated body, so that vacuum flows into the wall of the elongated body, thereby transforming the elongated body into a rigid configuration; and (4) moving the activation element in a second direction to disconnect the vacuum feed line from the vacuum port, allowing the elongated body to be ventilated, thereby transforming it into a flexible configuration.

[0055] Typically, in one embodiment, a handle for use with a rigidification device includes: a handle body configured to be attached to the rigidification device; a fluid chamber located within the handle body; an outlet in fluid communication with the fluid chamber and the wall of the rigidification device; and an activation element configured to move between a first position and a second position. The activation element is configured to transfer fluid from the fluid chamber to the wall of the rigidification device when moved from the first position to the second position, and to transfer fluid back to the fluid chamber when moved from the second position to the first position.

[0056] This embodiment and other embodiments of the invention may include one or more of the following features. The handle may further include an overflow chamber within the handle body and a pressure-reducing valve located between the fluid chamber and the overflow chamber. The pressure-reducing valve may be configured to open when the pressure in the fluid chamber reaches a predetermined maximum pressure to allow fluid to flow into the overflow chamber. The handle may further include a piston and a rolling diaphragm within the handle body. The piston may be configured to actuate the rolling diaphragm when the actuating element moves between a first position and a second position.

[0057] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) holding the handle of the rigidification device; (2) inserting the elongated body of the rigidification device into the body cavity while the rigidification device is in a flexible configuration; (3) when the rigidification device has reached a desired position in the body cavity, moving an activation element in a first direction to move fluid from the fluid chamber of the handle into the wall of the rigidification element, thereby transforming the rigidification device into a rigid configuration; and (4) moving the activation element in a second direction to move fluid from the wall of the rigidification element back into the handle, thereby transforming the rigidification device into a flexible configuration.

[0058] Typically, in one embodiment, a nested system includes a first rigidifying device and a second rigidifying device located radially inside the first rigidifying device. The second rigidifying device is axially slidable relative to the first rigidifying device. The first and second rigidifying devices are configured to be rigidified alternately by vacuum or pressure.

[0059] This embodiment and other embodiments of the invention may include one or more of the following features: The pressure may be greater than 1 atmosphere. The first rigidification device may be configured to rigidify by vacuum, and the second rigidification device may be configured to rigidify by pressure greater than 1 atmosphere. Both the first and second rigidification devices may include multiple layers. Vacuum or pressure may be configured to be supplied between the multiple layers. At least one of the multiple layers may be a braided layer.

[0060] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) inserting a first rigidification device into the body cavity while the first rigidification device is in a flexible configuration; (2) providing a vacuum or pressure to the first rigidification device to transform it into a rigid configuration that is harder than the flexible configuration; (3) inserting a second rigidification device in a flexible configuration through the first rigidification device while the first rigidification device is in a rigid configuration, such that the second rigidification device takes on the shape of the first rigidification device in the rigid configuration; and (4) providing a vacuum or pressure to the second rigidification device to transform the second rigidification device from a flexible configuration to a rigid configuration.

[0061] This embodiment and other embodiments of the invention may include one or more of the following features. Each rigidification device may include an elongated flexible tube and a braided layer. The braided layer can be compressed by providing a vacuum or pressure to transform the rigidification device into a rigid configuration.

[0062] Typically, in one embodiment, a method of propelling a rigidification device through a body cavity includes: (1) moving a first rigidification device in a flexible configuration until the first rigidification device reaches a desired position; (2) after the first rigidification device reaches the desired position, converting it into a rigid configuration by providing a vacuum or pressure to the first rigidification device; (3) after the first rigidification device is rigidified, moving a second rigidification device in a flexible configuration over the first rigidification device in a rigid configuration; (4) converting the second rigidification device into a rigid configuration by providing a vacuum or pressure to the second rigidification device; (5) converting the first rigidification device into a flexible configuration by removing the vacuum or pressure; and (6) passing the first rigidification device in a flexible configuration through a second elongated rigidification device until the first rigidification device reaches the desired position.

[0063] This embodiment and other embodiments of the invention may include one or more of the following features. The method may further include periodically changing the first and second rigidification devices to a flexible configuration to increase the curvature of the first and second rigidification devices to match the surrounding anatomical structure.

[0064] Typically, in one embodiment, a rigid rod includes: an inner bladder; a braided layer above the inner bladder; an outer sheath sealing over the inner bladder and the braided layer; and an inlet located between the outer sheath and the inner bladder, the inlet being configured to attach to a vacuum source. The rigid rod is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet. The rigid rod does not extend through any cavity therein.

[0065] Typically, in one embodiment, a method of advancing a rigidification device through a body cavity includes: (1) advancing the rigidification device through the body cavity; (2) inserting a flexible rod into the cavity of the rigidification device, the rod including an elongated flexible tube, a braided layer, and a bladder; (3) when the rod reaches a desired position in the cavity of the rigidification device, applying a pressure greater than one atmosphere to the central sealed cavity of the rod to force the braided layer to press against the elongated flexible tube, thereby transforming the rigidification device into a rigid configuration that is harder than the flexible configuration; and (4) when the rod is in the rigid configuration, further advancing the rigidification device on the rod.

[0066] Typically, in one embodiment, a method of performing cholangioscopy includes: (1) inserting a sheath into the colon in a flexible configuration, wherein the sheath includes an elongated flexible tube, a braided layer having multiple strands woven together, and an outer layer; (2) turning the distal end of the sheath toward the mastoid process; (3) activating a vacuum or pressure between the flexible tube and the outer layer to transform the sheath into a rigid configuration that is harder than the flexible configuration; (4) advancing a guidewire through the sheath into the bile duct or pancreatic duct when the sheath is in a rigid configuration; and (5) advancing the endoscope over the guidewire into the bile duct or pancreatic duct.

[0067] Typically, in one embodiment, a method of approaching a cardiac anatomy includes: (1) inserting the sheath into the cardiac anatomy when it is in a flexible configuration, wherein the sheath includes an elongated flexible tube, a braided layer having multiple strands woven together, and an outer layer; (2) orienting the distal end of the sheath toward a desired final position; (3) activating a vacuum or pressure between the flexible tube and the outer layer to transform the outer tube into a rigid configuration that is harder than the flexible configuration; and (4) passing the cardiac device through the rigid sheath.

[0068] This embodiment and other embodiments of the invention may include one or more of the following features: The desired final location may be the aortic valve. The cardiac device may be a transcatheter aortic valve replacement. The desired final location may also be the mitral valve. The cardiac device may also be a mitral valve replacement or a mitral valve repair element.

[0069] Any device described in this invention may include one or more of the following: The rigidification device may further include a sliding layer adjacent to the braided layer. The sliding layer may have a lower coefficient of friction than the braided layer. The rigidification device in the rigid configuration may be at least 2 times stiffer than the rigidification device in the flexible configuration. The rigidification device in the rigid configuration may be at least 5 times stiffer than the rigidification device in the flexible configuration. The braided layer has multiple strands braided together, with a braiding angle of 5-40 degrees relative to the longitudinal axis when the elongated flexible tube is straight. The braiding angle may be between 10 degrees and 35 degrees. The elongated flexible tube may include reinforcing elements extending therein. The reinforcing elements may include coils or multiple annular elements. The braided layer may include multiple strands braided together at 4-60 strands per inch. The braided layer may include multiple strands braided together. The strands may include polyethylene terephthalate or stainless steel. The braided layer may provide 30-70% coverage relative to the elongated flexible tube. The braided layer may include 96 or more strands braided together. The inlet may be configured to attach to a pressure source. The rigidification device may further include a bladder layer therein. The bladder layer may be configured to be pushed against the braided layer when pressure is applied through the inlet. The outer layer may further include multiple reinforcing elements. The inlet may be configured to attach to a vacuum source. The outer layer may be a thin, flexible sheath. The rigidification device may further include a radial gap between the braided layer and the outer layer. The thickness of the gap may be 0.00002-0.04 inches. The rigidification device may also include a steerable distal end. The rigidification device may also include a sealed channel located between the elongated flexible tube and the outer layer. The sealed channel may include a working channel, a cable guide, or an inflation chamber.

[0070] Generally, in one embodiment, a handle for use with a rigidification device includes a handle body configured to be attached to the rigidification device, a vacuum input configured to be connected to a vacuum source, a vacuum port communicating with a wall of the rigidification device, and a ring activation element configured to rotate between a first position and a second position. In the first position, the activation element connects the vacuum input to the vacuum port to provide a vacuum to the wall of the rigidification device. In the second position, the activation element disconnects the vacuum input from the vacuum port to allow ventilation of the wall of the rigidification device.

[0071] This embodiment and other embodiments may include one or more of the following features. The handle may also include a vent port in fluid communication with a vacuum input. An activation element in a first position may seal the vent port against a sealing element. The ring activation element may include one or more magnets configured to hold the activation element in a first or second position. The handle body may include a valve body, and the ring activation element is configured to rotate about the valve body. The valve body may include one or more additional magnets configured to engage with one or more magnets of the ring activation element. The handle may also include an indicator element configured to indicate whether the rigidification device is in a flexible or rigid configuration. The handle may also include a plurality of indicator elements arranged around the circumference of the handle.

[0072] Generally, in one embodiment, the catheter system includes a rigid catheter having a central lumen and a filament configured to be placed within the central lumen. The rigid catheter is configured to alternate between a rigid configuration and a flexible configuration. The filament is configured to have a pre-shaped form. When the rigid catheter is in a flexible configuration, the filament is more rigid than the rigid catheter. When the rigid catheter is in a rigid configuration, the filament is more flexible than the rigid catheter.

[0073] This embodiment and other embodiments may include one or more of the following features. The catheter system may further include a vacuum input configured to provide a vacuum to the wall of the rigid catheter to rigidify the catheter. The catheter system may further include a pressure input configured to provide pressure to the wall of the rigid catheter to rigidify the catheter. The filament may include a hyperelastic material. The filament may include nitinol. The wall of the catheter may include multiple layers. At least one of the multiple layers may include a braid.

[0074] Generally, in one embodiment, a method of using a rigid catheter includes: (1) inserting the rigid catheter into a body cavity in a flexible configuration; (2) converting the rigid catheter into a rigid configuration; (3) inserting a filament having a pre-shaped form into the catheter while the rigid catheter is in a rigid configuration, such that the filament takes the shape of the rigid catheter in the rigid configuration; and (4) converting the rigid catheter into a flexible configuration while the filament is inside the rigid catheter, such that the rigid catheter takes the pre-shaped form of the filament.

[0075] This embodiment and other embodiments may include one or more of the following features. Converting a rigid catheter to a rigid configuration may include applying pressure to the wall of the rigid catheter. Converting a rigid catheter to a flexible configuration may include releasing pressure from the wall of the rigid catheter. Converting a rigid catheter to a rigid configuration may include applying a vacuum to the wall of the rigid catheter. Converting a rigid catheter to a flexible configuration may include releasing a vacuum from the wall of the rigid catheter. The filament may include a hyperelastic material. The filament may include nitinol. The method may also include converting the rigid catheter to a rigid configuration while the rigid catheter is in a pre-formed shape of the filament. The method may also include removing the filament by pulling it proximally through the rigid catheter while the rigid catheter is in a rigid configuration and the filament is in a pre-formed shape. The method may also include performing coronary artery catheterization through the rigid catheter while the rigid catheter is in a rigid configuration and the filament is in a pre-formed shape. The method may also include entering head and neck vessels through the rigid catheter from the aortic arch while the rigid catheter is in a rigid configuration and the filament is in a pre-formed shape. The method may also include entering the bile duct or pancreatic duct through the rigid catheter while the rigid catheter is in a rigid configuration and the filament is in a pre-formed shape. This method may also include endoscopic retrograde cholangiopancreatography (ERCP).

[0076] Generally, in one embodiment, a system for manufacturing a coil-wound tube includes an outer tube, an inner tube concentric with the outer tube and having a plurality of holes therein, an air chamber located between the outer and inner tubes, a thin tubular membrane lining the inner periphery of the inner tube, and an open cavity formed within the thin tubular membrane. When a vacuum is supplied to the air chamber, the thin tubular membrane is configured to expand radially outward toward the inner tube to increase the diameter of the cavity. When the vacuum is released from the air chamber, the thin tubular membrane is configured to move away from the inner tube to decrease the diameter of the cavity.

[0077] This embodiment and other embodiments may include one or more of the following features. The outer tube, inner tube, and thin tubular membrane are secured together by female and male end caps. The female and male end caps form a seal in the air chamber. The thin tubular membrane may include silicone. The inner tube may include perforated metal, perforated plastic, braided fabric, textile, or textured tubing. The outer tube includes metal, polyetherimide, or polyetheretherketone.

[0078] Generally, in one embodiment, a method of manufacturing a coil-wound tube includes: (1) providing a vacuum to an air chamber formed between an inner vent tube and a concentric outer tube to pull a thin tubular membrane toward the inner vent tube; (2) inserting a mandrel into a cavity formed by a thin film while pulling the film toward the inner periphery of the inner vent tube, the mandrel having a matrix and reinforcing elements; and (3) releasing the vacuum from the air chamber to cause the thin tubular membrane to contract against the matrix and reinforcing elements, wherein the pressure from the contraction forms a composite tube of the matrix and reinforcing elements.

[0079] This embodiment and other embodiments may include one or more of the following features. The method may further include pressurizing the air chamber to press the thin tubular membrane against the substrate and reinforcing element. The method may further include heating the substrate and reinforcing element while pressing the thin tubular membrane against the substrate and reinforcing element. The method may further include providing a vacuum to the cavity. The thin film may include silicone.

[0080] Generally, in one embodiment, a method of performing cardiac surgery includes: (1) inserting a first catheter of a flexible configuration into or near a cardiac anatomy; (2) converting the first catheter into a rigid configuration when it reaches a first cardiac position; (3) inserting a second catheter of a flexible configuration into or near a cardiac anatomy; (4) converting the second catheter into a rigid configuration when it reaches a second cardiac position, wherein the distal tips of the first and second catheters are substantially coaxial and positioned relative to each other when the first and second catheters are in the first and second cardiac positions; and (5) performing cardiac surgery using a first cardiac tool extending through the first rigid catheter and a second cardiac tool extending through the second rigid catheter.

[0081] This embodiment and other embodiments may include one or more of the following features. The method can be performed in a closed heart without cardiopulmonary support. The method may further include orienting the tip of a first catheter to a first cardiac location or orienting the tip of a second catheter to a second cardiac location. Orienting the first catheter to a rigid configuration includes activating a vacuum or pressure within the wall of the first catheter, and orienting the second catheter to a rigid configuration includes activating a vacuum or pressure within the wall of the second catheter. The wall of the first catheter or the wall of the second catheter may include multiple strands braided together. The first cardiac location may be in the left atrium, and the second cardiac location may be in the left ventricle. The cardiac procedure may be mitral valve repair or replacement. The first cardiac location may be in the right atrium, and the second cardiac location may be in the right ventricle. The cardiac procedure may be tricuspid valve repair or replacement. The first catheter may be inserted via a vein, and the second catheter via an artery. The vein may be the femoral vein, and the artery may be the femoral artery. The procedure may include annulusoplasty. The procedure may include manipulating sutures through cardiac tissue. The first cardiac location or the second cardiac location may be a cardiac chamber. Insertion of the first catheter or the second catheter may include antegrade insertion. Insertion of the first catheter or the second catheter may include retrograde insertion.

[0082] Generally, in one embodiment, a method of performing cardiac surgery includes: (1) inserting a first catheter of a flexible configuration into a cardiac anatomy via a vein; (2) converting the first catheter into a rigid configuration when it reaches a first cardiac location; (3) inserting a second catheter of a flexible configuration into a cardiac anatomy via an artery; (4) converting the second catheter into a rigid configuration when it reaches a second cardiac location; and (5) performing cardiac surgery using a first cardiac tool extending through the first rigid catheter and a second cardiac tool extending through the second rigid catheter.

[0083] This embodiment and other embodiments may include one or more of the following features. The method can be performed in a closed heart without cardiopulmonary support. The method may further include turning the tip of a first catheter to a first cardiac location or turning the tip of a second catheter to a second cardiac location. Transforming the first catheter into a rigid configuration may include activating a vacuum or pressure within the wall of the first catheter. Transforming the second catheter into a rigid configuration may include activating a vacuum or pressure within the wall of the second catheter. The wall of the first catheter or the wall of the second catheter may include multiple strands braided together. The first cardiac location may be in the left atrium, and the second cardiac location may be in the left ventricle. The cardiac procedure may be mitral valve repair or replacement. The first cardiac location may be in the right atrium, and the second cardiac location may be in the right ventricle. The cardiac procedure may be tricuspid valve repair or replacement. The vein may be the femoral vein, and the artery may be the femoral artery. The procedure may include annulusoplasty. The procedure may include manipulating sutures through cardiac tissue. The first or second cardiac location may be a cardiac chamber. Insertion of the first or second catheter may include antegrade insertion. Insertion of the first or second catheter may include retrograde insertion.

[0084] Typically, in one embodiment, the tip of a medical device includes a conical outer shell and an inner shell flush with the outer shell. The conical outer shell has a proximal end and a distal end. The inner shell has an annular member and a plurality of protrusions extending from the annular member toward the distal end.

[0085] This embodiment and other embodiments may include one or more of the following features: The material of the inner shell may be more rigid than the material of the conical outer shell. The material of the inner shell may be harder than the material of the outer conical material. The conical outer shell may include a thermoplastic elastomer or silicone. The conical outer shell may include a material having a hardness of 50A or lower. The inner shell may include a material with a hardness greater than 50A. The conical outer shell may include polypropylene, polytetrafluoroethylene, high-density polyethylene, or low-density polyethylene. Each protrusion may taper gradually from the annular member to the distal end. Each protrusion may include a movable hinge. The movable hinge may be configured such that the protrusion can bend radially outward at the movable hinge. The tip may further include a cavity extending from the proximal end to the distal end. The distal end may be configured to abut a mirror extending through the cavity. The gap between the outer diameter of the mirror and the inner diameter of the distal end may be less than 0.04 inches. The gap may be less than 0.01 inches.

[0086] Generally, in one embodiment, a robotic system includes an inner elongated conduit, an outer elongated conduit concentric with a first inner elongated conduit, and a cassette located at the proximal ends of the first and second elongated conduits. The cassette is configured to alternately advance and retract the outer elongated conduit relative to the inner elongated conduit.

[0087] This embodiment and other embodiments may include one or more of the following features. The robot system may also include a drive unit configured to actuate mechanisms on the housing to advance and retract an outer elongated conduit relative to an inner elongated conduit. The housing may be further configured to steer the inner or outer elongated conduit. The housing may include one or more discs configured to rotate to activate cables of the inner or outer elongated conduit, thereby steer the inner or outer elongated conduit. The housing may include discs configured to rotate to advance and retract the outer elongated conduit relative to the inner elongated conduit. The outer elongated conduit may include a frame at its proximal end, and the frame may be configured to engage with the discs to advance and retract the outer elongated conduit relative to the inner elongated conduit. The inner and outer elongated conduits may be configured to be rigidified by applying a vacuum or pressure to the walls of the inner or outer elongated conduits. The housing may include an eccentric cam configured to actuate a vacuum or pressure. The robot system may also include a bellows configured to actuate a vacuum or pressure.

[0088] Generally, in one embodiment, a robotic system includes an inner elongated conduit, an outer elongated conduit concentric with a first inner elongated conduit, a housing located at the proximal ends of the first and second elongated conduits, and a drive unit configured to connect to the housing. The drive unit is further configured to actuate mechanisms on the housing to rigidify the inner and outer elongated conduits.

[0089] This embodiment and other embodiments may include one or more of the following features. The cassette may be further configured to alternately advance and retract an outer elongated conduit relative to an inner elongated conduit. The drive unit may be further configured to actuate a mechanism on the cassette to advance and retract the outer elongated conduit relative to the inner elongated conduit. The cassette may be further configured to steer either the inner or outer elongated conduit. The cassette may include one or more discs configured to rotate to activate the cables of the inner or outer elongated conduit, thereby steer either the inner or outer elongated conduit. The cassette includes discs configured to rotate to advance and retract the outer elongated conduit relative to the inner elongated conduit. The outer elongated conduit may include a frame located at its proximal end, configured to engage with the discs to advance and retract the outer elongated conduit relative to the inner elongated conduit. The inner and outer elongated conduits may be configured to be rigidified by applying a vacuum or pressure to the walls of the inner or outer elongated conduits. The mechanism on the cassette may include an eccentric cam. The mechanism on the cassette may include a bellows.

[0090] Generally, in one embodiment, the rigidification device includes an elongated flexible tube, an outer layer above the flexible tube, an inlet located between the elongated flexible tube and the outer layer, a plurality of linkages extending together with a distal end of the rigidification device, and a plurality of cables configured to activate the plurality of linkages. The inlet is configured to provide a vacuum or pressure between the elongated flexible tube and the outer layer to transform the rigidification device from a flexible configuration to a rigid configuration. The distal end is configured to be deflected by the plurality of cables when the rigidification device is in a flexible configuration. When the rigidification device is in a rigid configuration, the distal end is configured to have a fixed orientation.

[0091] This embodiment and other embodiments may include one or more of the following features. Multiple linkage devices may be located radially inside the elongated flexible tube. The rigidification device may also include a braided layer located between the elongated flexible tube and the outer layer. An inner layer may include reinforcing elements. The reinforcing elements may include coils. The inner layer may have a first thickness proximal to the multiple linkage devices and a second thickness extending together with the multiple linkage devices. The first thickness may be greater than the second thickness.

[0092] Generally, in one embodiment, a method of propelling a medical device through a body cavity includes: (1) inserting the rigidification device into the body cavity while the rigidification device is in a flexible configuration, (2) orienting the rigidification device in the flexible configuration to a desired position, and (3) activating pressure or vacuum between the layers of the rigidification device to transform the rigidification device into a rigid configuration and hold the distal end in a fixed orientation. Orientation includes activating cables of a plurality of linkages connected to the distal end of the rigidification device.

[0093] This embodiment and other embodiments may include one or more of the following features: Multiple linkage devices may be located radially inside each layer of the rigidification device. The layers of the rigidification device may include braided layers. The layers of the rigidification device may include inner layers. The inner layers may include reinforcing elements. The reinforcing elements may include coils.

[0094] Generally, in one embodiment, the rigidification device includes an elongated flexible tube, a braided layer over the elongated flexible tube, an outer layer over the flexible tube and the braided layer, an airbag sealed around the outer layer, a fitting located within the airbag and around the elongated flexible tube, and an inflation chamber. The braided layer or outer layer terminates at the fitting. The inflation chamber extends from a proximal end of the rigidification device to the fitting and is configured to supply inflation fluid to the airbag.

[0095] This embodiment and other embodiments may include one or more of the following features. The accessory may include an anti-clogging element located at the distal end of the inflation chamber. The anti-clogging element may be fabric, a breathable material, or a permeable material.

[0096] Generally, in one embodiment, the rigidification device includes an elongated body and a handle. The elongated body includes an inner capsule, a braided layer above the inner capsule, and an outer layer above both the inner capsule and the braided layer. The handle is attached to the elongated body and includes an annular capsule adapter having an inner surface and an outer surface. The inner capsule is coupled to the inner surface, and the braided layer is coupled to the outer surface.

[0097] Any method described in this invention may include one or more of the following: the method may further include releasing a vacuum or pressure after activating a vacuum or pressure to convert a rigid device back to a flexible configuration. The method may be performed in the gastrointestinal tract. The method may be performed in the heart. The method may be performed in the kidneys. The method may be performed in the lungs. The method may be performed in the brain. Attached Figure Description

[0098] The novel features of the invention are specifically mentioned in the claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and drawings, which illustrate exemplary embodiments utilizing the principles of the invention, in which: Figure 1 A rigidification device is shown.

[0099] Figure 2A-2B A portion of the woven layer of the rigidification device is shown.

[0100] Figure 3 This is a graph showing the relationship between the bending force and the weaving angle when the rigidification device is placed in a vacuum.

[0101] Figures 4A-4D An exemplary woven fabric form is shown.

[0102] Figures 5A-5B An exemplary woven fabric pattern is shown.

[0103] Figures 6A-6D Various designs for the braided layer terminals of the rigidification device are shown.

[0104] Figure 7 The inner layer of the rigidification device is shown.

[0105] Figures 8A-8F Different coil designs are shown for a layer in a rigidification device.

[0106] Figures 9A-9B A corrugated reinforcing element is shown for use in a layer of a rigidification device.

[0107] Figures 10A-10E The notch and pocket reinforcement elements used in a layer of the rigidification device are shown.

[0108] Figure 11A-11BA cut tube reinforcement element for a layer in a rigidification device is shown.

[0109] Figure 12A-12B An exemplary rigidification shape of the rigidification device is shown.

[0110] Figures 13A-13D An exemplary vacuum rigidification device is shown.

[0111] Figures 14A-14B An exemplary pressure rigidification device is shown.

[0112] Figure 15 This is a graph showing the relationship between the bending strength and pressure of a rigidification device.

[0113] Figure 16A-16O Various examples of pressure rigidification devices are shown.

[0114] Figures 17A-17D A rigidification device including an integrated working channel is shown.

[0115] Figures 18A-18B A rigidification device including a spiral working channel is shown.

[0116] Figures 19A-19B A rigid device comprising multiple spiral working channels is shown.

[0117] Figures 20A-20B A rigidification device comprising multiple working channels extending downward along the central cavity is shown.

[0118] Figure 21 A rigid device is shown, with its working channel extending to its side.

[0119] Figure 22 A tool that can be used with the working channel of a device such as a rigidification device is shown.

[0120] Figure 23 A rigidification device with a distal portion is shown.

[0121] Figure 24 A rigid device with a distal portion is shown, the distal portion having a weave pattern independent of the proximal portion of the device.

[0122] Figure 25 A rigid device with a distal portion is shown, which has multiple passive linkage devices.

[0123] Figure 26 A rigid device with a distal portion is shown, which has multiple actively controlled linkages.

[0124] Figures 27A-27ESeveral actively controlled linkage devices are shown.

[0125] Figure 28 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0126] Figure 29 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0127] Figure 30 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0128] Figure 31 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0129] Figure 32 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0130] Figure 33 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0131] Figure 34 An embodiment of a rigidification device is shown, which includes a cable extending within a layered wall.

[0132] Figure 35 A rigidification device is shown, which includes a cable extending downward along a central cavity.

[0133] Figure 36 An embodiment of a rigidification device is shown, which includes a cable spirally wound around its periphery.

[0134] Figure 37 An embodiment of a rigidification device is shown, which includes a cable spirally wound around its periphery.

[0135] Figures 38A-38B An embodiment of a rigidification device is shown, which includes a cable spirally wound around its periphery.

[0136] Figures 39A-39B A rigidification device is shown, comprising a cable spirally wound therein. Figure 40A-40D An exemplary linkage device for the remote portion is shown.

[0137] Figures 41A-41BA rigidification device with a distal portion is shown, the distal portion including a linkage mechanism located on the rigidification portion.

[0138] Figure 42A A rigidification device with a distal portion is shown, the distal portion including a linkage mechanism located within the rigidification portion.

[0139] Figure 42B A rigid device with a steering cable is shown, which is attached to a wall near the far end.

[0140] Figures 43A-43C A rigidification device with an actively deflectable distal portion is shown.

[0141] Figures 44A-44C A rigidification device with independent rigidification chambers along its length is shown.

[0142] Figures 45A-45D A rigid device with an airbag and an inflation chamber is shown.

[0143] Figures 46A-46B An embodiment of a suction tip for a device such as a rigidification device is shown.

[0144] Figures 47A-47B An embodiment of a suction tip for a device such as a rigidification device is shown.

[0145] Figures 48A-48B An embodiment of a suction tip for a device such as a rigidification device is shown.

[0146] Figures 49A-49D An embodiment of a handle used with a rigidification device is shown.

[0147] Figures 50A-50B An embodiment of an actuation element for a rigid device handle is shown.

[0148] Figures 51A-51C An embodiment of an actuation element for a rigid device handle is shown.

[0149] Figures 52A-52C An embodiment of an actuation element with a connector for a rigid device handle is shown.

[0150] Figures 53A-53D An embodiment of a handle used with a rigidification device is shown.

[0151] Figures 54A-54B An embodiment of a handle used with a rigidification device is shown.

[0152] Figures 55A-55CAn embodiment of an actuation element for a rigid device handle is shown.

[0153] Figures 56A-56G An embodiment of a handle for use with a vacuum rigidification device is shown.

[0154] Figures 57A-57C An embodiment of a handle used with a pressure rigidification device is shown.

[0155] Figures 58A-58E An embodiment of a pre-filled handle for use with a pressure rigidification device is shown.

[0156] Figure 59 A rigid device with an imaging element mounted on its side is shown.

[0157] Figure 60 A rigid guide is shown.

[0158] Figures 61A-61B A rigid device with a side channel mechanism is shown.

[0159] Figure 62 A nested rigid system is shown.

[0160] Figure 63 A nested rigidification system is shown, which has a cover between the inside and outside of the rigidification device.

[0161] Figures 64A-64B A nested rigidification system is shown, wherein the external rigidification device includes steering and imaging functions.

[0162] Figures 65A-65H An exemplary use of a nested rigid system is shown.

[0163] Figure 66 A rigid bar is shown.

[0164] Figure 67 A rigid rod for use with a colonoscope is shown.

[0165] Figures 68A-68B An exemplary rigidification device in which a mirror is incorporated is shown.

[0166] Figures 69A-69B The use of rigidification devices in the gastrointestinal tract is illustrated.

[0167] Figures 70A-70B A method of using a rigidification device for ERCP is shown.

[0168] Figures 71A-71B A method of using a rigidification device for ERCP is shown.

[0169] Figures 72A-72D A method of using a rigidification device for ERCP is shown.

[0170] Figures 73A-73B A method for using a rigidification device in the heart to create a channel to the left atrium is shown.

[0171] Figures 74A-74B A method for performing vascular branch therapy using a rigid device in the heart is shown.

[0172] Figures 75A-75C This paper demonstrates a method for mitral valve repair using a rigidification device in the heart.

[0173] Figures 76A-76B A method for using a double-rigidification device in the heart is shown.

[0174] Figure 77 A rigidification device for use as a cannula needle is shown.

[0175] Figure 78 A rigidification device for use at the aortic bifurcation is shown.

[0176] Figure 79 A rigidification device for mitral valve repair is shown.

[0177] Figure 80 A rigidification device with a distal payload for mitral valve repair is shown.

[0178] Figure 81A-81F A method for controlling a work tool using a rigidification device is shown.

[0179] Figure 82A-82J A handle is shown for use with a rigidification device.

[0180] Figures 83A-83E The use of a double-rigidification system to obtain annulusoplasty rings via sutures is shown.

[0181] Figure 84A-84E Another method is shown using two rigid catheters to attach valvuloplasty rings.

[0182] Figures 85A-85B A compression system for forming a composite tube is shown.

[0183] Figure 86A-86F The method using a rigidification device and preformed yarn is shown.

[0184] Figures 87A-87C The torsion layer used for the rigidification device is shown.

[0185] Figure 88 This is a cross-sectional view of an exemplary reinforcing layer.

[0186] Figure 89 It displays a steerable, rigid tip.

[0187] Figure 90A-90B A rigid device with airbags around it is shown.

[0188] Figure 91 The handle and proximal end of the pressure rigidification device are shown.

[0189] Figure 92 The cross-section of the distal tip of the rigidification device is shown.

[0190] Figures 93A-93D This demonstrates a rigid system for robot control.

[0191] Figures 94A-94B The mechanism of a rigid system for controlling an actuated robot is shown.

[0192] Figure 95 The drive unit of a rigid system for robot control is shown.

[0193] Figure 96 The guide of a rigid system for robot control is shown.

[0194] Figures 97A-97B Another embodiment of a guide for a rigid system controlled by a robot is shown.

[0195] Figure 98 Another embodiment of a guide for a rigid system controlled by a robot is shown.

[0196] Figure 99 Tools for use with rigidification systems in robot control are shown.

[0197] Figure 100 A slider is shown for use with a rigidification system for robot control.

[0198] Figure 101A-101B This demonstrates a rigid system for robot control.

[0199] Figure 102 The pivot arm of a rigid system controlled by a robot is shown.

[0200] Figure 103A-103B An exemplary distal tip for use in a rigidification device is shown.

[0201] Detailed Implementation Method (Device) In general, the present invention describes a rigidification device (e.g., an outer sheath) configured to assist in the transport of endoscopes (e.g., endoscopes) or other medical instruments through curved or looped portions of the body (e.g., blood vessels). The rigidification device can be long, thin, and hollow, and can rapidly transform from a flexible configuration (i.e., relaxed, soft, or loose) to a rigid configuration (i.e., rigid and / or retaining its shape when rigidified). Multiple layers (e.g., coiled or reinforcing layers, sliding layers, braided layers, encapsulated layers, and / or sealing sheaths) can collectively form the walls of the rigidification device. The rigidification device can be transformed from a flexible configuration to a rigid configuration, for example, by applying a vacuum or pressure to its walls or within the walls. With the removal of the vacuum or pressure, these layers can readily shear or move against each other. Under the application of vacuum or pressure, these layers can transform into a state in which they exhibit significantly enhanced resistance to shearing, movement, bending, and buckling, thereby providing rigidity to the system.

[0202] The rigidification device described in this invention can provide rigidity for a variety of medical applications, including catheters, sheaths, endoscopes (e.g., endoscopes), wires, or laparoscopic instruments. The rigidification device can be used as a standalone add-on or integrated into the body of the catheter, sheath, endoscope, wire, or laparoscopic instrument. The device described in this invention can also provide rigidity for non-medical structures.

[0203] Figure 1 An exemplary rigidification device system is illustrated. The system includes a rigidification device 300 having a wall having multiple layers, including a braided layer, an outer layer (a portion of which is cut away to reveal the underlying braided layer), and an inner layer. The system also includes a handle 342 with a vacuum or pressure inlet 344 to provide vacuum or pressure to the rigidification device 300. An actuating element 346 can be used to turn the vacuum or pressure on and off, thereby allowing the rigidification device 300 to switch between flexible and rigid configurations. The distal tip 339 of the rigidification device 300 can be smooth, flexible, and non-damaging to facilitate distal movement of the rigidification device 300 through the body. Further, the tip 339 can taper from distal to proximal to further facilitate distal movement of the rigidification device 300 through the body.

[0204] Figure 2A-2B A portion of an exemplary braided layer 209 for a rigidification device such as device 300 is shown. Braided layer 209 may include braided strands 233. Braided layer 209 may be, for example, a tubular braid.

[0205] When the rigidification device (e.g., device 300) is in a straight (unbent) configuration, the braiding angle α of the strands 233 relative to the longitudinal axis 235 of the rigidification device can be less than 45 degrees, for example, less than or equal to 40 degrees, less than or equal to 35 degrees, or less than or equal to 25 degrees. (Reference) Figure 3 The bending strength of a rigidification device decreases with increasing braid angle α (when the rigidification device is straight or unbent). That is, a rigidification device with a braid angle of 45 degrees (the typical minimum angle for torque or torsional braids; larger angles are typically used for conduit shaft reinforcement) has a bending strength in vacuum that is 27% of that of a rigidification device with a braid angle of 25 degrees in vacuum. Therefore, having a smaller braid angle (e.g., less than 45 degrees, such as 40 degrees or less, or 35 degrees or less) advantageously ensures that the rigidification device (e.g., device 300) remains rigid (resisting changes in configuration) during bending in vacuum (and similarly under pressure). Additionally, when the rigidification device is in a straight (unbent) configuration, the braid angle α can be greater than 5 degrees, for example greater than 8 degrees, for example greater than 10 degrees, for example 15 degrees or greater. Having a braid angle α within this range ensures that the braid remains sufficiently flexible for bending when in a flexible configuration (i.e., when not rigidified under vacuum or pressure). Therefore, when the rigidification device is in a straight configuration, the braiding angle α of the strands 233 relative to the longitudinal axis 235 of the rigidification device can be 5 to 40 degrees, for example, 10-35 degrees, 15-25 degrees, such as approximately 5, 10, 15, 20, 25, 30, 35, or 40 degrees. When the rigidification device is in a straight (unbent) configuration, the braiding angle α of 5-40 degrees of the strands 233 relative to the longitudinal axis 235 of the rigidification device ensures that the rigidification device is sufficiently flexible to bend in a flexible configuration (e.g., when not under vacuum / pressure) and sufficiently rigid in a rigid configuration (e.g., when under vacuum or pressure). Furthermore, it should be understood that the strands 233 are configured to slide relative to each other, so that the braiding angle α will change with the flexing and bending of the rigidification device. Having a braiding angle α between 5 and 40 degrees also advantageously ensures that the strands 233 can move freely relative to each other without causing the fibers to collide with each other and prevents further changes in angle.

[0206] Furthermore, the braided layer 209 may have between 4 and 60 picks per inch, for example, 8, 10, 12, 14, 16, 18, 20, or 25 picks per inch. In one embodiment, the tube formed by layer 209 has a diameter of 0.578 inches and has 12-14 picks per inch.

[0207] In some embodiments, the braided layer 209 (or any braided layer described in this invention) may be configured such that the rigidification device of this invention has a high stiffness ratio (i.e., the ratio between the stiffness in the rigid configuration (e.g., when a vacuum or pressure is applied) and the stiffness in the flexible configuration (e.g., when no vacuum or pressure is applied)). For example, the stiffness ratio may be greater than 5, such as greater than 6, greater than 9, greater than 9, or greater than 10. Referring to Table 1 below, six vacuum rigidification devices (samples AF) were manufactured and their cantilever bending stiffness was tested at a length of 4 inches and a deflection of 1 / 2 inch, respectively, under atmospheric pressure (flexible configuration) and vacuum (rigid configuration). As shown, reducing the braid angle increases the stiffness of the rigidification device. Samples E and F specifically show the stiffness difference between the braid at a typical torque angle (sample E, 47.7 degrees, rigidity of 0.529 lbf) and the braid with a smaller angle (sample F, 27.2 degrees, rigidity of 1.455 lbf). As also shown in Table 1, rigidification devices with smaller angles (e.g., less than 45 degrees or 35 degrees, such as samples AD and F) can have much higher stiffness ratios (e.g., ratios greater than 5, 6, 9, or 10) than rigidification devices with larger angles (e.g., 45 degrees or more, such as sample F), which can have stiffness ratios less than 5. Table 1 also shows that the stiffness ratios of samples A and B are both greater than 5. Sample B has a weave angle of 14.9 degrees. Compared to sample A, sample B has a lower stiffness ratio, but its absolute stiffness is higher because the strands of sample B are oriented closer to the longitudinal axis (therefore, sample B has higher stiffness in a flexible configuration).

[0208] Table 1 - Vacuum Rigidification Devices

[0209] Referring to Table 2 below, three pressure stiffening devices were manufactured (sample GI) and their cantilever bending stiffness was tested at atmospheric pressure (flexible configuration) and 4 atmospheres (rigid configuration) at a length of 4 inches and a deflection of 1 / 2 inch. All samples included 35-45% coverage and a braid with 96 strands and one filament per strand. As shown, reducing the braid angle increases the stiffness of the stiffening device. As shown in Table 2, stiffening devices with smaller angles have a higher stiffness ratio than those with larger angles. In some embodiments, the stiffness ratio of the pressure stiffening device of the present invention is greater than 10, for example greater than 15, for example greater than 20.

[0210] Table 2 - Pressure Rigidification Devices

[0211] Furthermore, in some embodiments, the woven fabric of the woven layer 209 may have a coverage of 30%-70%, such as 40%-60%, like 30%, 40%, 50%, 60% or 70%, where coverage refers to the percentage of the lower surface covered or obscured by the woven fabric.

[0212] In some embodiments, the braided layer 209 can be formed by winding each individual strand around an inner tube or rigidification device and / or an independent helical mandrel, such that the strands 233 interweave with each other. In one embodiment, the braided layer 209 can be thermoformed on a mandrel of 0.50-0.60 inches, for example, 0.56 inches. Furthermore, in some embodiments, during manufacturing, the braided layer can be mounted on the tube or mandrel to a diameter smaller than the core diameter (i.e., smaller than the diameter of the initially manufactured braid). Radially compressing the braid in this way can reduce the braid angle (while also reducing the PPI, increasing the overall length of the tubular braided layer, and increasing the braid coverage) within a range that provides a high rigidity factor.

[0213] The strands 233 can be rectangular / flat (e.g., with a long side of 0.001-0.060 inches, such as 0.005 inches, 0.007 inches, 0.010 inches, or 0.012 inches, and a short side of 0.0003-0.030 inches, such as 0.001 inches, 0.002 inches, or 0.003 inches), round (e.g., with a diameter of 0.001-0.020 inches, such as 0.005 inches, 0.01 inches, or 0.012 inches), or elliptical. In some embodiments, some strands 233 can be flat, and some strands 233 can be round.

[0214] In some embodiments, the strand 233 may be made of a metal filament (e.g., stainless steel, aluminum, nickel-titanium, tungsten, or titanium), a plastic (nylon, polyethylene terephthalate, PEEK, polyetherimide), or a high-strength fiber (e.g., aromatic polyamide, ultra-high molecular weight polyethylene, or liquid crystal polymer such as Vectran). In some embodiments, the strand 233 may be made of a multilayer composite material, such as a metal core with a thin, elastic coating. In a specific example, the strand 233 may comprise a round nylon (or a metal filament with a diameter of 0.010 inches) wound together with a flat, aluminized PET with a cross-sectional dimension of 0.002 inches × 0.002 inches. In some embodiments, the material of the strand 233 of the braid may be a material with a known high coefficient of friction. For example, the strand 233 may be an integral structure or have a coating, such that the strand comprises an aluminum coating on an aluminum core, a copper coating on a copper core, a silver coating on a silver core, or a gold coating on a gold core. As another example, strand 233 can be coated with a highly elastic material (e.g., a lower-stiffness elastomer can be coated on top of a higher-modulus substrate). As another example, strand 233 can be made of styrene copolymer, polycarbonate, or acrylic acid.

[0215] Within the braided layer 209, 12-800 strands 233 may extend, for example, 24, 48, 96, 120, 144, or more strands 233. In some embodiments, there are 96 or more strands, 120 or more strands, 200 or more strands, or 240 or more strands. Due to the increased interaction between the strands, more strands can advantageously help to achieve rigidity in the braided fabric.

[0216] refer to Figures 4A-4D The woven fabric of any rigidification device described in this invention can have a variety of different weave patterns. For example, see reference... Figure 4A The weave of layer 1709 can be a full diamond pattern, in which two adjacent strands 1733a and b extend first above the two strands and then below them. (See reference...) Figure 4B The weave of layer 1709 can be a full-pattern design, wherein each strand 1733a extends above and below the two strands in the opposite manner to its adjacent strand 1733b. (See reference...) Figure 4C The weave of layer 1709 can be a diamond half-width pattern, wherein each strand 1733a extends above and below another strand, opposite to the adjacent strand 1733b. (See reference) Figure 4D The weave of layer 1709 may include one or more longitudinal strands 1733c passing through cross strands 1733a, 1733b.

[0217] refer to Figures 5A-5B Each share of wire 1833 can include a single filament 1818 ( Figure 5A ) or multiple fine filaments 1818a-c (in Figure 5B In the diagram, three filaments 1818a-c are shown in each strand 1833. The filaments 1818 can be selected (i.e., their diameter, spacing, and modulus can be specifically customized) to reduce curl (wavy or bent filaments). Reducing curl helps the system provide enhanced compressive and torsional resistance, which translates into increased system stiffness.

[0218] Exemplary specific braided layer embodiments JN are shown in Table 3.

[0219] Table 3 - Exemplary Woven Fabrics

[0220] In use, a vacuum or pressure can be provided between the walls of the rigidification device described in this invention, causing the braided layers and adjacent layers to contract and / or separate, thereby transitioning between flexible and rigid configurations. Thus, the rigidification device described in this invention can advantageously transform from very flexible to very rigid when activated by the user. When a vacuum or pressure is applied, the braid or strands can contract or expand radially to mechanically fix or lock in place relative to each other. Therefore, when a vacuum or pressure is applied, the rigidification device can change from a flexible configuration to a rigid configuration (thus fixing the rigidification device in the shape it was in before the vacuum or pressure was applied).

[0221] refer to Figures 6A-6D In some embodiments, one or both ends of the braided layer 5609 of the rigidification device 5600 as described in this invention may be coupled to another layer of the device 5600 to prevent the strands 5633 of the braid from unraveling. Furthermore, the ends of the strands 5633 may be coupled in a manner that allows relative movement of the strands 5633 during buckling of the rigidification device 5600 when the rigidification device 5600 is in a flexible configuration (i.e., to prevent the device 5600 from rigidifying or twisting, which in turn would cause dragging at the tip 5629, a situation that could occur when the strands 5633 are constrained).

[0222] For example, such as Figure 6A As shown, the tip 5629 of the braided layer 5609 may include a low-hardness material coating 5634, such as silicone or polyurethane, which is stretchable and / or flexible. Therefore, the ends of the strands 5633 can be encapsulated by the coating 5634 (thus preventing loosening), while the strands still move with the coating 5634 when the coating 5634 stretches and / or flexes. The coating 5634 can be very thin, for example, with a thickness between 0.005 and 0.250 inches (e.g., approximately 1 / 32 inch thick).

[0223] As another example, such as Figure 6B As shown, the tip 5629 of the braided layer 5609 may include an annular ring 5601z surrounding it. In some embodiments, the ring 5601z may be formed by melting the tip of the strand 5633. In other embodiments, the ring 5601z may be a separate element bonded to the strand 5633 (e.g., bonded to less than 20%, less than 10%, or less than 5% of the strand 5633). In some embodiments, there may be two bonding locations spaced approximately 180 degrees apart from each other. The ring 5601z can advantageously ensure that the strand 5633 does not unravel and can also allow the strands to move considerably relative to each other below the ring 5601z. The ring 5601z may be made of, for example, rubber, polyimide, PTFE, silicone, polyurethane, latex, or ePTFE.

[0224] As another example, such as Figure 6C As shown, the tip 5629 of the braided layer 5609 can have a varying warp and weft density along the tip 5629, with a greater warp and weft density at the tip and a smaller warp and weft density towards the center. Therefore, the angle of the ply 5633 relative to the longitudinal axis at the tip 5629 can be greater than the angle at the rest of the layer 5609. For example, while the ply 5633 at the center of the device 5600 can have an angle of 45 degrees or less relative to the longitudinal axis of the device 5600 (e.g., 40 degrees or less, 35 degrees or less, 25 degrees or less, or 20 degrees or less), the ply 5633 at the tip 5629 can have an angle greater than 45 degrees relative to the longitudinal axis, for example, between 45 degrees and 60 degrees (e.g., 35 degrees, 45 degrees, or 55 degrees). The variation in the braid angle can be a continuous variation at the tip 5629 and / or can be produced by joining two separate braids together. A larger angled strand 5633 can be glued to the innermost layer at the tip 5629. By providing a larger angle at the tip 5629 of the braid, the tip 5629 can remain flexible when curved or bent, even when the strand 5633 is fixed to the inner layer 5615. In some embodiments, the increased braid angle at the tip 5629 can be achieved by varying the speed at which the core inside the tubular braid is pulled during manufacturing.

[0225] As another example, such as Figure 6D As shown, the tip 5629 of the braided layer 5609 can be flipped and combined with the innermost layer 5615 (and / or other layers radially inward of the braided layer 5609). This tip 5629 can be more flexible than the non-flipped tip 5629 because it includes an additional (flipped) length within which the strands 5633 can move.

[0226] In some embodiments, the proximal and distal ends of the braided layer 5609 may have different treatments (e.g., the distal end may have such...). Figures 6A-6D The first treatment shown, while the proximal end can have, as Figures 6A-6D The second treatment shown.

[0227] In some embodiments, the braided layer described herein may be braided to have a diameter that allows the braided layer to be inherently biased onto a first adjacent layer and offset from a second (opposite) adjacent layer. For example, the braided layer may be formed to have a diameter smaller than that of the innermost layer, and then the braided layer may be stretched to fit onto the innermost layer (in order to bias the braided layer onto the innermost layer). As another example, the braided layer may be formed to have a diameter larger than that of the outermost layer, and the braided layer may be compressed to fit therein (in order to bias the braided layer onto the outermost layer). In other embodiments, the braided layer may be formed to have a diameter similar to that of the adjacent layers (or between two adjacent layers). These diameter options can be used to adjust the performance of the rigidification system, particularly the initial baseline flexibility and pressurized / vacuum stiffness.

[0228] In some embodiments, the rigidification device of the present invention (e.g., rigidification device 300) may include one or more sliding layers adjacent to a braided layer (e.g., braided layer 209). The sliding layers may be configured to reduce friction between the braid and the adjacent layers to allow the adjacent layers (and particularly the braided layer) to more easily shear or move relative to each other, especially when no vacuum or pressure is applied to the rigidification device, to maximize the flexibility of the flexible configuration. The sliding layers may advantageously enhance the baseline flexibility of the rigidification device to allow the layers to move relative to each other. In one embodiment, the sliding layer may include a powder, such as talc or cornstarch. In particular, powdered sliding layers may advantageously reduce friction without significantly increasing the thickness of the device, thereby enhancing the flexibility of the rigidification device in a flexible configuration. The sliding layer may be made of a low coefficient of friction material, such as a thin film fluoropolymer (FEP, chemical film, PTFE, with a thickness of 2-50 micrometers). In one embodiment, the sliding layer may be a coating. In one embodiment, the sliding layer may be a sliding additive added to an elastomer. In one embodiment, the sliding layer may be a sheath of a thin plastic film with inherent lubricating properties, such as low-density polyethylene (LDPE). In one embodiment, the sliding layer may be made of a thin, spirally wrapped film, such as a 0.0005-inch FEP or a 0.00025-inch chemical film (St. Gobain). In another embodiment, the sliding layer may be made of grease, oil, or other liquid.

[0229] The rigidification device of this invention may include an innermost layer configured to provide an inner surface against which additional layers (such as a braided layer) can be reinforced, for example, when a vacuum or pressure is applied within the wall of the rigidification device. This layer may further provide a seal (i.e., be leak-proof) for the wall and may be robust enough to provide resistance to radial collapse even during the rigidification process, during bending and / or compression of the rigidification device. Reference Figure 7 In some embodiments, the innermost layer 8815 may include a reinforcing element 8850z or a coil within the matrix 8851z. The reinforcing element 8850z may be a continuous spiral coil or a closed loop with gaps between them (which exhibits greater resistance to collapse than a spiral coil). Additionally, the inner layer 8815 may include an inner membrane 8852z and an outer membrane 8853z on one or both sides. In some embodiments, each of the elements 8853z, 8852z, 8850z / 8851z may have a thickness of 0.0002-0.015 inches.

[0230] The reinforcing element 8850z can be, for example, a metal wire, such as a wire made of stainless steel, nitinol, or tungsten. The reinforcing element 8850z can also be, for example, a high-strength fiber (such as Kevlar, dynamic fiber, Victorinox, Tektronix, or carbon fiber). The reinforcing element 8850z can be, for example, a support, a structure cut from a tube, or a braid. In some embodiments, the reinforcing element 8850z can be a round wire (e.g., with a diameter of 0.0005-0.030 inches, such as 0.001 inches, 0.003 inches, 0.005 inches, 0.007 inches, or 0.009 inches). In some embodiments, the reinforcing element 8850z may be a rectangular wire (e.g., having a width of 0.001-0.100 inches, such as 0.010 inches, 0.020 inches, 0.030 inches, 0.040 inches, 0.050 inches, 0.060 inches, 0.070 inches, 0.080 inches, 0.090 inches, or 0.100 inches, and / or the rectangular wire may have a thickness of 0.0003-0.020 inches, such as 0.001 inches, 0.003 inches, 0.005 inches, 0.007 inches, or 0.010 inches). In other embodiments, the reinforcing element 8850z may have an elliptical cross-section and / or may comprise multiple individual strands and / or may have a rectangular cross-section with rounded corners. In some embodiments, the reinforcing element 8850z may be cut from a single tube using, for example, a laser to create the gap. In some embodiments, no reinforcing element is used.

[0231] In some embodiments, the reinforcing element 8850z may be an element with a high aspect ratio (e.g., a high RE width relative to the RE height, such as an aspect ratio exceeding 5:1, exceeding 10:1, exceeding 11:1, or approximately 12:1). It should be noted that in... Figure 7 In this context, RE width is the width of the reinforcing element 8850z, RE height is the height or thickness of the reinforcing element 8850z, and RE gap is the distance between the reinforcing elements 8850z. The aspect ratio of the height of the reinforcing element 8850z can advantageously help prevent external pressure caused by the parallelogram-shaped collapse of the reinforcing element 8850z within the innermost layer 8815. Parallelogram-shaped collapse occurs when the coil helix moves from approximately perpendicular to the coil's central axis to parallel to the coil's central axis (the helix essentially "flips"). Furthermore, it may be advantageous to prevent parallelogram-shaped collapse if the RE gap between the reinforcing elements 8850z does not exceed three times the RE height, for example, not more than twice the RE height, or for example, not more than 1.5 times the RE height. Additionally, a ratio of the inner diameter of the hollow tube having the innermost layer 8815 to the width of the reinforcing layer 8850z within the innermost layer 8815 to less than 5, for example, less than 4.5, or for example, approximately 4.3, also helps prevent parallelogram-shaped collapse.

[0232] The substrate 8851z can be a TPU or TPE with very low hardness, such as a TPU or TPE with a hardness equal to or less than 60A, 50A, 40A, 30A, 20A, or 10A. In some embodiments, the substrate 8851z can be TPU, TPE, PET, PEEK, polyester film, polyurethane, or silicone. The inner and outer films 8852z and 8853z can similarly include TPU, TPE, PET, PEEK, Mylar, polyurethane, or silicone. In some embodiments, the inner and outer films 8852z and 8853z can be applied by spraying, impregnation, wrapping into sheets or tubes, pulling through a solvent bath, melting, and / or solidification. In some embodiments, layer 8815 does not include the inner and / or outer films 8852z and 8853z, and / or may include additional films. The inner and / or outer films 8852z and 8853z can produce smooth inner and outer surfaces.

[0233] In a specific example of the innermost layer 8815 used in the pressure system, this layer is fabricated as a hollow tube with an inner diameter of 0.260 inches, an RE width of 0.050 inches, an RE height of 0.008 inches, and an RE gap of 0.010 inches. Membranes 8853z are omitted on both sides. Membranes 8852z (on both sides of the substrate 8851z and the reinforcing element 8850z) are both made of polyurethane (100% strain corresponds to 600 psi pressure). The thickness of the substrate 8851z and each membrane 8852z is approximately 0.006 inches, for a total wall thickness of 0.018 inches. This structure can resist collapse under external pressure exceeding 10 atmospheres.

[0234] In a second specific example of the innermost layer 8815 used in a pressure system, membrane 8853z is omitted on both sides. The RE width is 0.050 inches, the RE height is 0.008 inches, and the RE gap is 0.010 inches. Membrane 8852z is a higher stiffness elastomer, such as an elastomer with a stress of 2000 psi at 100% strain, and a thickness of approximately 0.001 inches. The matrix 8851z can be 50A polyurethane. The matrix 8851z can be deposited as a thermoplastic elastomer cord stock, such as a rectangular cross-section of 0.008 inches or a circular cross-section of 0.010 inches. This cord stock can also be deposited with an increased axial modulus (but not transverse modulus) by co-extruding it with filaments (e.g., 0.001 inches in diameter) or fibers at its core.

[0235] In a third specific example of the innermost layer 8815 used in a pressure system, the reinforcing element 8850z can be a wire with a high aspect ratio. For example, in a square stainless steel wire, layer 8815 can have a RE height of 0.005 inches, an RE width of 0.060 inches, and an RE gap of 0.006 inches. The tube with the innermost layer 8815 formed has an inner diameter of 0.26 inches. Elements 8852z and 8851z can be 80A polyurethane with a thickness of approximately 0.002 inches. Furthermore, layer 8851z can be 50A polyurethane (e.g., deposited from a heated vessel that includes molten polyurethane and orifices for precise distribution by pressure). This exemplary innermost layer 8815 structure can resist collapse under external pressures exceeding 10 atmospheres, such as pressures exceeding 12 atmospheres, or pressures exceeding 13 atmospheres.

[0236] In a specific example of the innermost layer 8815 used in a vacuum system, the outer membrane 8853z on one side (e.g., the outer or top side) is omitted. The membrane 8852z above the reinforcement / substrate (outer side) comprises 0.005 inches of 50A polyurethane, the substrate 8851z is made of 0.005 inches of 50A polyurethane, the reinforcement element 8850z is stainless steel wire, the membrane 8852z below the reinforcement / substrate (inner side) comprises 0.0025 inches of 50A polyurethane, and the bottom outer membrane 8853z is 0.004 inches of 80A polyurethane. The RE width is 0.020 inches, the RE height is 0.005 inches, and the RE gap is 0.010 inches. The bottom outer membrane 8853z is a hydrophilic coating. The tube formed by layer 8815 has an inner diameter of 0.551 inches.

[0237] Although Figure 7 While the structures are presented symmetrically, it should be understood that the innermost layer 8815 does not need to have symmetrically arranged membranes 8852z and 8853z. For example, neither layer is at the bottom (inside the substrate / reinforcement), but both layers are at the top. Furthermore, it should be understood that the materials of the two innermost membranes 8852z do not need to be the same, nor do the materials of the two outermost membranes 8853z need to be the same.

[0238] The innermost reinforcing element can have various configurations. For example... Figure 8D-8F As shown, the reinforcing element 9205z can be a multi-starting-point coil winding (e.g., as...). Figure 8F The two starting points shown are as follows: Figure 8E The three starting points shown, or as... Figure 8D (As shown, there are 4 starting points). When using multi-start coil windings, the gap between reinforcing elements along the longitudinal axis can be the same as with a single coil, but the number of starting points can be 2, 3, 4, 5, 6, 7, 8, 9, or more. A single starting point produces a wire angle close to vertical (e.g., 2 degrees off-vertical), while the multi-start method produces a wire angle that biases the coils to tilt in one direction, away from vertical (e.g., 4, 6, 10, 15, or even 20 degrees). This larger angle can be used to make the innermost layer less prone to tilting or structural collapse under pressure, because coils with a larger tilt tend to support each other to achieve stability. Figures 8A-8C The individual starting points (coils) of the multi-start reinforcing element 9205Z are shown. Figure 8C Showing Figure 8F One of the coils, Figure 8B Showing Figure 8E One of the coils, Figure 8A Showing Figure 8D One of the coils.

[0239] In some embodiments, refer to Figures 9A-9BThe reinforcing element 8950z can be a series of wavy or corrugated lines (or wound corrugated lines as described in this invention). Figure 9B As shown, when the device is loaded, the corrugated reinforcing element 8950z moves toward colliding with itself, compressing the matrix 8851Z between the filaments and resisting parallelogram-shaped collapse. In one specific embodiment, the innermost layer with such corrugated lines may have an RE height of 0.005 inches, an RE width of 0.060 inches, and an RE gap of only 0.006 inches. The corrugated wave can vary from the center line by + / - 0.03 inches (that is, the wave amplitude is 0.060 inches). The wave can repeat once every 0.3 inches (i.e., the wavelength is 0.3 inches).

[0240] In some embodiments, refer to Figures 10A-10C The reinforcing element 9050z may include alternating pocket wires 9052z and notched wires 9053z. Upon unloading, the pockets and notches of each respective element can be separated (e.g., ...). Figure 10D (As shown). However, when loaded, the notch of filament 9053z moves toward colliding with the pocket of filament 9052z (as shown). Figure 10E As shown), the matrix 8851z between the compressed wires resists parallelogram-shaped collapse.

[0241] In some embodiments, reference Figure 11A-11B The reinforcing element 9150z can be a flexure design, for example, cut from a laser tube.

[0242] In some cases, the reinforcing element may be separate from the inner layer. For example, the reinforcing element may be radially positioned inside or outside the inner layer. The innermost layer may have a hardness of, for example, 30A to 80A. Furthermore, the wall thickness of the innermost layer may be between 0.0005 and 0.060 inches. In some embodiments, the innermost layer may include a lubricant or coating (e.g., a hydrophilic coating) on ​​its inner surface to improve the slippage of endoscopes or other instruments passing through it. The coating may be hydrophilic (e.g., Hydromer® coating or Surmodics® coating) or hydrophobic (e.g., fluoropolymer). The coating may be applied by methods such as dipping, coating, or spraying. The innermost layer may be a laminate with a low coefficient of friction.

[0243] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the matrix surrounding the reinforcing element may be composed of a material with high hydrolytic stability. That is, it is advantageous for the rigidification device described herein to maintain its structural integrity when exposed to immersion fluid environments (e.g., water, saline, gastric juice, or blood). If the matrix material is hygroscopic and thus absorbs fluid, the fluid can act as a plasticizer and soften the matrix, which may result in reduced resistance to pressure (or vacuum-based) structural collapse, thereby reducing the rigidity of the device. Therefore, in some embodiments, the matrix may be made of a hydrophobic material, thereby absorbing little or no fluid and advantageously maintaining its structural integrity even when immersed in a fluid. For example, the matrix may be made of polyethylene, polypropylene, polystyrene, thermoplastic elastomers (such as Chronoprene) TM and Teknor ApexMedallist TM It is made of polyvinyl chloride or PVC.

[0244] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the reinforcing element and the matrix can be bonded together by an adhesive. For example, the reinforcing element can be applied by dipping, spraying, or immersion of an adhesive thereon, and then the reinforcing element can be located within the matrix to jointly bond the matrix and the reinforcing element. In some embodiments, the reinforcing element and the matrix can have a final bond strength of up to 50 pounds per square inch. The adhesive can be, for example, Chemlok. TM Adhesives. By using adhesives to adhere reinforcing elements to the substrate, the reinforcing layer can remain intact to resist pressure and / or vacuum collapse.

[0245] For any reinforcing layer described herein (e.g., the innermost layer 8815), the reinforcing layer may be manufactured such that it has a final diameter (i.e., within the rigidification device) equal to or close to its net (i.e., manufactured) diameter, thereby ensuring that the matrix does not need to hold the reinforcing element to a specific diameter. For example, the final diameter of the reinforcing layer may be within 10% of the net diameter, such as within 5% of the net diameter, or even within 2% of the net diameter. A final diameter close to the net diameter advantageously ensures reduced internal stress in the reinforcing layer, thereby reducing creep and / or failure of the reinforcing layer. In some embodiments, the reinforcing element may be manufactured, for example, by yielding the reinforcing element when it is applied to the matrix, such as by passing the reinforcing element through a series of deformation rollers.

[0246] Any reinforcing layer described herein (e.g., the innermost layer 8815) may be configured to comprise alternating types of material along the longitudinal axis of the device. For example, see reference. Figure 88Layer 18815 may include alternating portions 18807y and 18806y, respectively composed of a high-hardness material and a low-hardness material. Furthermore, the high-hardness material portion 18807y may include a reinforcing element 18850z embedded therein. In some embodiments, the alternating portions 18807y and 18806y may be formed by a helical portion 18807y, but with a gap between the helical portions, which is subsequently filled by the lower-hardness material of portion 18806y. This design advantageously allows layer 18815 to have high stiffness at portion 18807y while maintaining flexibility and bendability at the hinge point created by portion 18806y. Therefore, a device including layer 18815 can have high stiffness and resistance to pressure / vacuum collapse while still maintaining high baseline flexibility.

[0247] For any reinforcing layer described herein (e.g., the innermost 8815), the layer may be a composite tube. See also Figures 85A-85B In some embodiments, the composite tube can be produced or manufactured by applying radial compression to the tube to laminate reinforcing elements (e.g., coils) into the matrix. As shown, the compression system 8590z may include an outer metal tube 8591z and a concentric inner vent tube 8592z (with an orifice 8596z). An air chamber 8593z may extend between the outer metal tube 8591z and the inner vent tube 8592z, the inner vent tube 8592z being connected to a vacuum or air source via a fitting 8597z. A silicone extrusion tube 8594z may be lined on the inner vent tube 8592z and form a cavity 8595z therein. The layers of the compression system 8590z may be held together at a first end 8502y by a female cap 8598z and a male cap 8599z. The outer metal tube 8591z and the inner vent tube 8592z may mate with the female cap 8598z. Furthermore, the silicone extrusion tube 8594z can be clamped between the female end cap 8598z and the male end cap 8599z, and the female end cap 8598z and the male end cap 8599z can be held together by fasteners 8501y such as screws. The second end 8503y of the compression system 8590z can be open, thereby allowing the mandrel and tube (with matrix and reinforcing elements) to pass through and be placed therein. The different tubes can be sealed together to maintain a seal in the air chamber 8593z (e.g., by having male and female end caps at the second end 8503y).

[0248] During use, a vacuum can be applied to the air chamber 8593z via accessory 8597z. This vacuum draws the silicone extrusion tube 8594z toward the inner vent tube 8592z, thereby enlarging the diameter of the cavity 8595z to allow placement of the mandrel and the tube containing the matrix and reinforcing element. Once the mandrel and the tube containing the matrix and reinforcing element are inserted, the vacuum can be removed, and the silicone extrusion tube 8594z can contract around the composite tube to laminate the reinforcing element into the matrix, thus forming the composite tube. In some embodiments, heat (e.g., 120°C to 220°C) may be further applied to ensure that the reinforcing element is embedded in the matrix.

[0249] In some embodiments, a vacuum may be applied to cavity 8595z once the mandrel and the tubes of the matrix and reinforcing elements have been inserted, and before the vacuum is removed from air chamber 8593z. The vacuum in cavity 8595z can be maintained for the remainder of the process and provides several benefits, including reducing the likelihood of air trapping when the silicone extrusion tube 8594z is compressed onto the mandrel after the external vacuum has been removed, promoting the removal of trapped air throughout the thermal cycle, and / or increasing the compressibility of the silicone extrusion tube 8594z due to the higher pressure differential when the interior is under vacuum. In some embodiments, to provide additional compression for the formation of the composite tube, pressure may be applied to air chamber 8593z via fitting 8597z while the mandrel and the tubes of the matrix and reinforcing elements are within cavity 8595z.

[0250] The internal vent tube 8592z provides a uniformly distributed vacuum along the length of the compression system 8590z and can be made of, for example, perforated metal, perforated high-temperature plastic, braided fabric (e.g., plastic or metal), textile, or textured tubing. Although described herein as a silicone extrusion tube 8594z, it should be understood that the extrusion tube 8594z can be additionally or alternatively made of other materials. For example, the extrusion tube 8594z can be made of any heat-resistant (i.e., temperatures up to 120°C to 220°C), biocompatible material (e.g., elastomer) that can extend outward and compress downward under vacuum. Similarly, the outer metal tube 8591z can alternatively or additionally be made of a rigid material other than metal, such as polyetherimide or polyetheretherketone.

[0251] In some embodiments, the radial compression provided to the silicone extrusion tube 8594z can be optimized by optimizing the thickness of the silicone extrusion tube 8594z (a greater thickness results in greater compression), the stiffness of the silicone extrusion tube 8594z (a greater stiffness results in greater compression), the external pressure on the silicone extrusion tube 8594z (a greater pressure results in greater radial compression), the internal vacuum on the silicone extrusion tube 8594z (a greater vacuum results in greater radial compression), and / or the natural diameter of the silicone extrusion tube 8594z (a smaller natural diameter results in higher compressive force). Furthermore, in some embodiments, the axial tension on the silicone extrusion tube 8594z can be optimized (high axial tension can lead to creep, while low compression can lead to wrinkling and / or trapped air).

[0252] In some embodiments, the braided layer may be integrated with or embedded in the matrix of any reinforcing layer (e.g., the innermost layer 8815).

[0253] Any rigidification device described herein may also include one or more torsion layers configured to enhance torsional stiffness. For example, a torsion layer may be included above an inner layer (e.g., the innermost layer 8815). The torsion layer may comprise one or more strips or filaments spirally wound at an angle (e.g., 45-75 degrees, or 50-70 degrees, relative to the longitudinal axis of the rigidification device). For example, as... Figures 87A-87C As shown, the innermost layer 8715 may include a first twisted layer 8702a wound in a first direction and a second twisted layer 8702b wound in the opposite second direction (e.g., the first layer 8702a may be wound at 70 degrees and the second layer 8702b may be wound at -70 degrees). In some embodiments, the two layers 8702a, 8702b may be sheared or slid relative to each other. For example, a sliding layer may be present between the two layers 8702a, 8702b. The twisted layer may be made of a material that exhibits both tensile and compressive loads (e.g., sheet metal or filament) or a material that exhibits high tensile loads but low compressive loads (e.g., multiple small-diameter filaments or fibers). Furthermore, the twisted layer may include a strip, filament, or fiber having a uniform cross-section (e.g., a circular cross-section) or a flat cross-section (e.g., a flat filament with a width to thickness ratio between 10:1 and 200:1). In some embodiments, a sliding layer may be present between the twisted layer and other layers of the device (e.g., the innermost layer). In some embodiments, the twisted layer may be part of or interwoven with another layer (e.g., a braided layer).

[0254] Figure 12A and 12B An exemplary rigidification device in a rigidification configuration is shown. When the rigidification device is rigidified, it is rigidified in the shape it was in before the application of vacuum or pressure; that is, it does not straighten, bend, or otherwise significantly change its shape (e.g., it can be in the shape of...). Figure 12A The ring structure shown or as Figure 12B The serpentine shape shown becomes stiff. This may be because the air hardening effect on the inner or outer layer (e.g., made of a winding tube) may only be a small percentage (e.g., 5%) of the stiffening device's maximum load capacity when bent, thus allowing the stiffening device to resist straightening. Once the vacuum or pressure is released, the braid or strands can unlock relative to each other and move again, thus allowing the stiffening device to bend. Furthermore, as the stiffening device becomes more flexible by releasing the vacuum or pressure, it retains the shape it was in before the vacuum or pressure was released to become flexible; that is, it does not straighten, bend, or otherwise significantly change its shape. Therefore, the stiffening device described in this invention can be transformed from a flexible, less stiff configuration to a more stiff configuration by restricting the movement between the strands of the braid (e.g., by applying a vacuum or pressure).

[0255] The rigidification devices described in this invention can rapidly switch between rigid and flexible configurations and, in some embodiments, have an unlimited number of switching cycles. As interventional medical devices are manufactured to be longer and inserted deeper into the human body, and as they are expected to be used for more demanding surgical procedures, the demand for precision and control increases. Selective rigidification devices (e.g., sheaths) as described in this invention can advantageously provide both the benefits of flexibility (when needed) and the benefits of rigidity (when needed). Furthermore, the rigidification devices described in this invention can be used, for example, in classic endoscopes, colonoscopes, robotic systems, and / or guidance systems, such as those described in International Patent Application PCT / US2016 / 050290, filed September 2, 2016, entitled “DEVICE FOR ENDOSCOPICANDANCEMNT THROUGH THE SMALL INTESTINE,” the entire contents of which are incorporated herein by reference.

[0256] The rigidification device described in this invention can be provided in various configurations, including different lengths and diameters. In some embodiments, the rigidification device may include a working channel (e.g., for typical endoscopic tools to pass through within the body of the rigidification device), an air bladder, a nesting element, and / or a lateral loading feature.

[0257] refer to Figures 13A-13D In one embodiment, the tubular rigidification device 100 may include walls having multiple layers (e.g., for instruments or endoscopes to be placed through) surrounding a lumen 120. A vacuum may be provided between the layers to rigidify the rigidification device 100.

[0258] The innermost layer 115 may be configured to provide an inner surface, for example, whereby the remaining layers can be reinforced against the inner surface when a vacuum is applied within the wall of the rigidification device 100. This structure can be configured to minimize bending forces / maximize flexibility under non-vacuum conditions. In some embodiments, as described above, the innermost layer 115 may include a reinforcing element 150z or a coil within the substrate.

[0259] The layer 113 above the innermost layer 115 (i.e. radially outward) can be a sliding layer.

[0260] Layer 111 can be a radial gap (i.e., a space). The gap layer 111 can provide space for the braided layer thereon to move within it (when no vacuum is applied), and provide space for the braided layer to move radially inward within it (when a vacuum is applied).

[0261] Layer 109 may be a first braided layer comprising braided strands 133, similar to those described elsewhere in this invention. The braided layer may be, for example, 0.001-0.040 inches thick. For example, the braided layer may be 0.001 inch, 0.003 inch, 0.005 inch, 0.010 inch, 0.015 inch, 0.020 inch, 0.025 inch, or 0.030 inch thick.

[0262] In some embodiments, such as Figure 13B As shown, the braid can have stretched or loop fibers 137. The loop fibers 137 can be spirally and / or woven into the braided layers. Furthermore, the loop fibers 137 can be positioned at 2-50 loops per inch, for example, 20-40 loops per inch. The loop fibers 137 can advantageously transmit high compressive stiffness in the radial direction (to resist torsion or outward bending), but can remain compliant in the direction of the longitudinal axis 135 of the rigidification device 100. That is, if compression is applied to the rigidification device 100, the braided layer 109 will attempt to expand its diameter upon compression. The loop fibers 137 can resist this radial expansion, thereby resisting compression. Therefore, the loop fibers 137 can provide a system that is flexible when bent, but still resistant to stretching and compression.

[0263] Layer 107 can be another radially spaced layer similar to layer 111.

[0264] In some embodiments, the rigidification device of the present invention may have more than one braided layer. For example, the rigidification device may include two, three, or four braided layers. (See reference...) Figure 13CLayer 105 may be a second braided layer 105. The second braided layer 105 may have any of the characteristics described with respect to the first braided layer 109. In some embodiments, the fabric of the second braided layer 105 may be the same as the fabric of the first braided layer 109. In other embodiments, the fabric of the second braided layer 105 may differ from the fabric of the first braided layer 109. For example, the fabric of the second braided layer 105 may include fewer strands and a larger braid angle α than the fabric of the first braided layer 109. Having fewer strands can help increase the flexibility of the rigidification device 100 (relative to the case where the second braid has the same or more strands), and a larger braid angle α can help reduce the diameter of the first braided layer 109 (e.g., if the first braided layer is compressed) while increasing / maintaining the flexibility of the rigidification device 100. As another example, the fabric of the second braided layer 105 may include more strands and have a larger braid angle α compared to the fabric of the first braided layer 109. Having more strands can produce a relatively strong and smooth layer, while having a larger braid angle α can help to reduce the diameter of the first braid layer 109.

[0265] Layer 103 may be another radially spaced layer similar to layer 111. Spaced layer 103 may have a thickness of 0.0002-0.04 inches, for example, about 0.03 inches. Thickness within this range ensures that the strands 133 of the braided layer can easily slide and / or bulge relative to each other to ensure flexibility of the rigidification device 100 during bending.

[0266] The outermost layer 101 is configured such that when a vacuum is applied to pull it toward the braided layers 105 and 109, the outermost layer 101 moves radially inward and adheres to the surface of the braided layer. The outermost layer 101 can be flexible and undamaged, and its ends can be sealed to form a vacuum-sealed chamber with layer 115. The outermost layer 101 can be elastic, for example, made of polyurethane. The hardness of the outermost layer 101 can be, for example, 30A-80A. Furthermore, the outermost layer 101 can have a thickness of 0.0001-0.01 inches, for example, approximately 0.001 inches, 0.002 inches, 0.003 inches, or 0.004 inches. Alternatively, the outermost layer can be a plastic, including, for example, LDPE, nylon, or PEEK.

[0267] In some embodiments, the outermost layer 101 may have, for example, tensile or circumferential fibers 137 extending therethrough. The circumferential fibers 137 may be made of, for example, aramids (e.g., Technora, nylon, Kelvar), polyaryl fibers, polyethylene fibers, carbon fibers, glass fibers, or plastics. Furthermore, the circumferential fibers 137 may be configured with 2-50 loops per inch, for example, 20-40 loops per inch. In some embodiments, the circumferential fibers 137 may be laminated within an elastic sheath. The circumferential fibers can advantageously provide higher stiffness in one direction compared to the other (e.g., can be very stiff in the circumferential direction but very compliant in the longitudinal axis direction of the rigidification device). Additionally, the circumferential fibers can advantageously provide low circumferential stiffness until the fibers are placed under tensile loads, at which point the circumferential fibers can suddenly exhibit high circumferential stiffness.

[0268] In some embodiments, the outermost layer 101 may include a lubricant, coating, and / or powder (e.g., talc) on its outer surface to improve the sliding of the rigidification device within the anatomical structure. The coating may be hydrophilic (e.g., Hydromer® coating or Surmodics® coating) or hydrophobic (e.g., fluoropolymer). For example, the coating may be applied by impregnation, coating, or spraying.

[0269] The innermost layer 115 may similarly include a lubricant, coating (e.g., a hydrophilic or hydrophobic coating) and / or powder (e.g., talc) on its inner surface, which is configured to allow for easier shearing between adjacent layers, especially when no vacuum is applied to the rigidification device 100, in order to maximize flexibility.

[0270] In some embodiments, the outermost layer 101 can be relaxed on the radially inward layers. For example, there can be a 0-0.200 inch diameter gap between the inner diameter of layer 101 (assuming it forms a tube) and the radially inward next layer (e.g., with a braided layer). This can make the vacuum-rigidified system more flexible when not under vacuum, while still maintaining a high rigidity factor. In other embodiments, the outermost layer 101 can be stretched somewhat on the radially inward next layer (e.g., a braided layer). For example, the zero-strain diameter of the tube forming layer 101 can be 0-0.200 inches smaller than the diameter of the radially inward next layer and stretched thereon. When not under vacuum, the system can have less flexibility than a system with a looser outer layer 101. However, it can also have a smoother appearance and is less likely to tear during use.

[0271] In some embodiments, the outermost layer 101 may be relaxed on the radially inward layers. A small positive pressure may be applied under layer 101 to gently expand layer 101 and allow the rigidification device to bend more freely in a flexible configuration. In this embodiment, the outermost layer 101 may be elastic and may retain compressive force on the fabric, thereby giving it stiffness. Once a positive pressure (sufficient to nominally unwind the sheath from the fabric, e.g., 2 pounds) is provided, the outermost layer 101 no longer contributes stiffness, which can enhance the baseline flexibility. When rigidification is required, a negative pressure (vacuum) may be used instead of a positive pressure to provide stiffness.

[0272] Vacuum can be supplied within the rigidification device 100 in the range of minimum vacuum to full atmospheric vacuum (e.g., approximately 14.7 psi). In some embodiments, a vent valve, regulator, or pump controller may be provided to allow the vacuum to be released to any intermediate level to provide variable stiffness capability. Vacuum pressure can advantageously rigidify the rigidification device structure by pressing braided sleeve layers against adjacent layers. The braid is naturally flexible when bent (i.e., when bent perpendicular to its longitudinal axis), and when the sleeve bends, the mesh structure formed by the interlaced strands deforms so that the braid conforms to the shape of the bend when placed on the inner layer. This causes the angle of each mesh element in the geometry of the mesh to change as the braided sleeve bends. When compressed between conformal materials (e.g., layers described herein), the mesh elements are locked at their current angles and have enhanced resistance to deformation when a vacuum is applied, thereby enabling the entire structure to be rigidified in bending when a vacuum is applied. Furthermore, in some embodiments, circumferential fibers passing through or on the fabric can bear tensile loads, which helps prevent localized twisting of the fabric when subjected to high bending loads.

[0273] When transitioning from a flexible to a rigid configuration, the stiffness of the rigidification device 100 can increase from a factor of 2 to over 30, for example, by 10, 15, or 20. In a specific example, the stiffness of a rigidification device similar to rigidification device 100 was tested. The tested rigidification device had a wall thickness of 1.0 mm and an outer diameter of 17 mm. A force was applied to the end of a 9.5 cm long cantilever section of the rigidification device until it deflected by 10 degrees. This required only 30 grams of force in flexible mode, while in rigid (vacuum) mode, it required 350 grams.

[0274] In some embodiments of the vacuum rigidification device 100, there may be only one braided layer. In other embodiments of the vacuum rigidification device 100, there may be two, three, or more braided layers. In some embodiments, one or more radial gap layers or sliding layers of the rigidification device 100 may be removed. In some embodiments, some or all of the sliding layers of the rigidification device 100 may be removed.

[0275] The braided layer described in this invention can serve as a variable stiffness layer. The variable stiffness layer may include one or more variable stiffness elements or structures that, when activated (e.g., when a vacuum is applied), increase bending stiffness and / or shear resistance, resulting in higher stiffness. Other variable stiffness elements may be used in addition to or in place of the braided layer. In some embodiments, a coupling may be used as a variable stiffness element, as described in International Patent Application PCT / US2018 / 042946, filed July 19, 2018, entitled “DYNAMICALLYRIGIDIZING OVERTUBE,” the entire contents of which are incorporated herein by reference. Optionally or additionally, the variable stiffness element may include particles or granules, plugging layers, sheets, rigidifying axial members, rigidifiers, longitudinal members, or basic longitudinal members.

[0276] In some embodiments, the rigidification device of the present invention can be rigidified by applying pressure instead of applying a vacuum. For example, see reference to Figures 14A-14B The rigidification device 2100 may be similar to the rigidification device 100, except that it may be configured to maintain a pressure (e.g., greater than 1 atmosphere) for rigidification instead of a vacuum. Therefore, the rigidification device 2100 may include multiple layers (e.g., for placing instruments or endoscopes through it) surrounding the cavity 2120. The rigidification device 2100 may include an innermost layer 2115 (similar to the innermost layer 115), a sliding layer 2113 (similar to the sliding layer 113), a pressure gap 2112, a bladder layer 2121, a gap layer 2111 (similar to the gap layer 111), a braided layer 2109 (similar to the braided layer 109) or other variable stiffness layers as described in this invention, a gap layer 2107 (similar to layer 107), and an outermost receiving layer 2101.

[0277] The pressure gap 2112 may be a sealed chamber that provides clearance for applying pressure to the layers of the rigidification device 2100. Pressure may be supplied to the pressure gap 2112 using a fluid or gas-filled inflation / pressure medium. The inflation / pressure medium may be water or saline solution, or, for example, a lubricating fluid such as oil or glycerin. The lubricating fluid may, for example, help the layers of the rigidification device 2100 slide against each other in a flexible configuration. During rigidification of the rigidification device 2100, an inflation / pressure medium may be supplied to the gap 2112 and may be partially or completely drained from the gap 2112 to convert the rigidification device 2100 back to a flexible configuration. In some embodiments, the pressure gap 2112 of the rigidification device 2100 may be connected to a pre-filled pressure source, such as a pre-filled syringe or pre-filled insulator, thereby reducing the setup time required by the physician.

[0278] The capsule 2121 may be made of, for example, a low-hardness elastomer (such as Shore 20A to 70A) or a thin plastic sheet. The capsule 2121 may be formed from a plastic or rubber sheet that has been longitudinally sealed to form a tube. For example, the longitudinal seal may use a butt joint or an overlap joint. For example, an overlap joint may be formed longitudinally in a rubber sheet by melting rubber at the overlap joint or by using an adhesive. In some embodiments, the thickness of the capsule 2121 may be 0.0002-0.020 inches, for example, approximately 0.005 inches thick. The capsule 2121 may be soft, high-friction, elastic, and / or wrinkle-prone. In some embodiments, the capsule 2121 is a polyolefin or polyester. The capsule 2121 may be formed, for example, by using methods for forming heat-shrinkable tubes, such as extruding a base material and then thinning the walls using heat, pressure, and / or radiation. When pressure is applied through pressure gap 2112, the bladder layer 2121 can expand through gap layer 2111 to push braid layer 2109 toward outermost receiving layer 2101, thereby reducing the relative movement of braided strands.

[0279] The outermost receiving layer 2101 may be a tube, such as an extruded tube. Optionally, the outermost receiving layer 2101 may be a tube in which reinforcing members (e.g., wires, including wires with circular or rectangular cross-sections) are encapsulated in an elastic matrix, similar to the innermost layer described in other embodiments of the invention. In some embodiments, the outermost receiving layer 2101 may include a helical spring (e.g., made of round or flat wire), and / or a tubular braid (e.g., a braid made of round or flat wire) and a thin elastic sheet of other elements not incorporated into the layer. The outermost receiving layer 2101 may be a tubular structure with a continuous and smooth surface. This facilitates the outer member to abut against it and slide under locally high contact loads (e.g., nested configurations as further described in the invention). Furthermore, the outer layer 2101 may be configured to support compressive loads, such as compression. Furthermore, the outer layer 2101 (e.g., having reinforcing elements) may be configured to prevent the rigidification device 2100 from changing diameter even when pressure is applied.

[0280] Because both the outer layer 2101 and the inner layer 2115 include reinforcing elements, the braided layer 2109 can be reasonably constrained in both diameter shrinkage (under tensile load) and diameter increase (under compressive load).

[0281] The rigidity of the rigidification device 2100 can be increased by using pressure instead of vacuum to convert a flexible state into a rigid state. For example, in some embodiments, the pressure supplied to the pressure gap 2112 can be between 1 and 40 atmospheres, for example, between 2 and 40 atmospheres, for example, between 4 and 20 atmospheres, for example, between 5 and 10 atmospheres. In some embodiments, the supplied pressure is approximately 2 atmospheres, approximately 4 atmospheres, approximately 5 atmospheres, approximately 10 atmospheres, or approximately 20 atmospheres. In some embodiments, the rigidification device 2100 can exhibit a relative bending stiffness (measured in a simple cantilever configuration) variation of 2-100 times from a flexible configuration to a rigid configuration, for example, 10-80 times, for example, 20-50 times. For example, the rigidification device 2100 can have a relative bending stiffness variation of approximately 10, 15, 20 or 25, 30, 40, 50 or more times from a flexible configuration to a rigid configuration. Figure 15 A graph showing the relationship between the bending strength of the rigidification device described in this invention and pressure is presented. As shown in the figure, the bending strength of the rigidification device increases with the increase of the pressure applied to the wall.

[0282] Simplified versions of the walls of various pressure-rigidifying devices similar to the rigidification device 2100 are in Figure 16A-16O As shown in the image. For example, Figure 16AThe rigidification device 2200a includes an innermost layer 2215a, a pressure gap 2212a, a bladder layer 2221a sealed to the outermost layer 2201a, a braided layer 2209a, and an outer receiving layer 2201a (similar to that described in the rigidification device 2100). The rigidification device 2200a also includes end caps 2292a at its proximal and distal ends to seal the pressure therein. When pressure is supplied to the pressure gap 2212a via inlet 2293a, the bladder layer 2221a is pressed against the braided layer 2209a, which in turn is pressed against the outermost layer 2201a to prevent the strands of the braid from moving relative to each other.

[0283] refer to Figure 16J The rigidification device 2200j is similar to the rigidification device 2200a, except that a sliding layer 2213j and a stiffening layer 2298j are added. Layer 2213j can be a sliding layer as described in this invention, for example, comprising a coated film or powder. Layer 2298j can be a stiffening layer, similar to layers 2201j and 2215j, and can include a stiffening element 2250z as described elsewhere in this invention. The additional stiffening layer 2298j can work in conjunction with the inner layer 2215j. For example, in a flexible configuration, the two layers 2215j and 2298j can easily slide past each other (via the sliding layer 2213j), and in a rigid configuration (i.e., when pressure is applied), they adhere to each other to form a rigid composite structure. Layer 2298j can be a high-hardness elastic rubber, such as a TPU (thermoplastic polyurethane) or TPE (thermoplastic elastomer) with a hardness greater than or equal to 60A, 70A, 80A, or 90A. When the tube is in a flexible state, layers 2215j and 2298j can easily shear or move relative to each other (e.g., due to sliding layer 2213j), making the system less flexible than when the layers are bonded together. When the tube is in a rigid state (e.g., when pressure is applied), layers 2215j, 2298j, and 2213j can lock together and function as a single bonded layer to resist wall collapse of the rigidification device 2200j. Similar to other embodiments, when pressure is applied to the gap 2212j to rigidify the device 2200j, the braided layer 2205j can push against the outer layer 2201j.

[0284] refer to Figure 16B The rigidification device 2200b is similar to the rigidification device 2200a, except that the pressure gap 2212b is surrounded by an inverted bladder layer 2221b (or a double bladder), i.e., the bladder layer 2221b includes a side adjacent to the braided layer 2205b and a side adjacent to the innermost layer 2215b. When pressure is supplied to the pressure gap 2212b (within both sides of the bladder layer 2221b), the bladder layer 2221b can expand toward the innermost layer 2215b and the braided layer 2209b (which can in turn be pushed toward the outermost layer 2201b).

[0285] refer to Figure 16C The rigidification device 2200c is similar to the rigidification device 2200a, except that the bladder layer 2221c is sealed to the innermost layer 2215c instead of the outermost layer 2201c. When pressure is supplied to the pressure gap 2212c via the inlet 2293c, the bladder layer 2221c is pressed against the braided layer 2209c, which in turn is pressed against the outermost layer 2201c.

[0286] refer to Figure 16D The rigidification device 2200d is similar to the rigidification device 2200b, except that the innermost layer 2215d is a spring element instead of a winding tube. Because the pressure is in the inverted bladder layer 2221d, the inner layer 2215d itself does not need to be sealed.

[0287] refer to Figure 16E The rigidification device 2200e is similar to the rigidification device 2200a, except that the innermost layer 2215a is replaced by an internal payload 2294e, which is sealed at both the proximal and distal ends and may include multiple cavities (e.g., working channel 2291e, pressure channel 2292e, and flushing channel 2293e).

[0288] refer to Figure 16F The rigidification device 2200f is similar to the rigidification device 2200a, except that the braided layer 2209f is inside the pressure gap 2212f and the bladder layer 2221f, so that the pressure provided to the pressure gap 2212f causes the bladder layer 2221f to push the braided layer 2209f inward, and the braided layer 2209f in turn pushes the innermost layer 2215f.

[0289] In some embodiments, the pressure rigidification device may include two braided layers (e.g., having the same or different braided characteristics). For example... Figure 16M An exemplary rigidification device 2200m with two braided layers 2209m and 2205m is shown. The two braided layers 2209m and 2205m sandwich two bladders 2221m and 2217m (and / or a single annular bladder) therebetween. When pressure is applied to the pressure gap 2212m between the two bladders, the outer braided layer 2205m is pushed radially outward toward the outer layer 2201m, while the inner braided layer 2209m is pushed radially inward toward the inner braided layer 2215m, thereby rigidifying the device 2200m.

[0290] Figure 16NAnother exemplary rigidification device 2200n with two braided layers 2209n and 2205n is shown. The two braided layers 2209n and 2205n are located adjacent to each other between the bladder layer 2221n (not shown) and the outer tube 2201n. When pressure is supplied to the pressure gap 2212n, the bladder 2221n forces the two braided layers 2209n and 2205n together and against the outer tube 2201n. When pressurized, the braided layers 2209n and 2205n can interweave, thereby enhancing the rigidity of the device 2200n.

[0291] refer to Figure 16K The rigidification device 2200k is similar to the rigidification device 2200a, except that an annular ring 2219k (e.g., comprising fibers and adhesive) is located around each end of the braided layer 2209k and the bladder layer 2221k to attach the bladder layer 2221k to the innermost layer 2215k (thereby maintaining pressure within the pressure gap 2212k when pressure is supplied through the inlet 2293k). For example, the annular ring 2219k may comprise high-strength fibers, such as Kevlar or Dyneema. Furthermore, the adhesive may be, for example, cyanoacrylate. In some embodiments, the adhesive may also be placed at the end between the innermost layer 2215k and the bladder layer 2221k and also surround the inlet tube.

[0292] Figure 16GA rigidification device 2200g with a gap inlet 2293g and a vent inlet 2223g is shown. Inlet 2293g is connected to a pressure gap 2212g (connected via a pressure line 2294g). Inlet 2223g is connected to a gap 2206g around the braided layer 2209g (between the pouch 2221g and the outermost layer 2201g). The device 2200g can be rigidified in one or more different configurations. In a first rigid configuration, pressure can be applied to inlet 2293g, while the vent inlet 2223g can be opened or vented to atmospheric pressure. Thus, the pressure supplied to the pressure gap 2212g through inlet 2293g can push the braided fabric 2209g towards the outermost layer 2201g, which in turn can force any air in the gap 2206g to escape through the vent inlet 2223g. Allowing air to escape through vent 2223g enables a tighter mechanical fit between the braided layer 2209g and the outer layer 2201g, thereby enhancing the rigidity of the device 2200g. In a second rigid configuration, pressure can be applied to vent 2293g, and a vacuum can be applied to vent 2223g. This causes the rigidified device 2200g to become stiffer than in the first configuration, as the vacuum helps move the braided layer 2209g toward the outer layer 2201g. The device 2200g can also have one or more different flexible configurations. In a first flexible configuration, both vent 2293g and vent 2223g can be open to atmospheric pressure. This allows the braided layer 2209g to loosen relative to the outer layer 2201g, and as the braided layer 2209g moves freely relative to the outer layer 2201g, the rigidified device 2200g becomes flexible. In the second flexible configuration, a low pressure (e.g., 5-10% above atmospheric pressure) can be supplied to the inlet 2293g and the venting inlet 2223g. This causes a slight separation between the outermost layer 2201g and the innermost layer 2215g, which provides additional space for the braided layer 2209g to move freely. Therefore, this makes the rigidification device 2200g more flexible than in the first rigidification configuration. Furthermore, providing a low pressure above atmospheric pressure in the flexible configuration allows the rigidification device 2200g to be introduced into the body with a very small diameter (e.g., making the pressure gap 2212g essentially zero), and then the low pressure can be supplied to the inlet 2293g and the venting inlet 2223g to slightly increase the pressure gap 2212g, thereby providing more space for the braided layer 2209g to move freely.

[0293] Figure 16HA rigidification device 2200h is shown, with its bellows 2243h connected to a pressure line 2294h. The pressure gap 2212h, pressure line 2294h, and bellows 2243h can all be configured to be filled with a sealed pressure-transmitting medium, such as distilled water, a salt solution, or oil. The pressure-transmitting medium can be a radiopaque fluid, which advantageously allows for clearer visualization of the rigidification device during surgery using fluoroscopy. The pressure-transmitting medium can be added to the rigidification device just before use and / or during device manufacturing. In use, activating actuator 2288h compresses bellows 2243h, thereby reducing the volume of the pressure medium in bellows 2243h that flows through pressure line 2294h to pressure gap 2212h, causing a pressure increase in pressure gap 2212h and triggering movement of braided layer 2209h toward outer layer 2201h. Vent inlet 2223h can be opened to the atmosphere to allow gas to escape from the space 2206h surrounding braided layer 2209h. Furthermore, the action of the reversing actuator 2288h causes a pressure drop in pressure gap 2212h as the pressure medium moves back into bellows 2243h. Actuator 2288h can be, for example, a solenoid, voice coil, lead screw, valve, or rotary cam. In some embodiments, pressure line 2294h can be clamped or flattened to increase pressure in pressure gap 2212h instead of using bellows 2243h.

[0294] Figure 16I A rigidification device 2200i is shown, comprising two water collection devices 2230i and 2228i, respectively. Water collection devices 2230i and 2228i may include fluid media, such as water, and gaseous media, such as air. Pressure or vacuum, or a combination thereof, may be applied to inlets 2293i and 2223i. The illustrated water collection device configuration likely means that regardless of the pressurization state of each gap 2206i or 2212i (increased pressure, vacuum, or atmospheric pressure), no air or gas is present in the rigidification device. If a gap leaks during surgery, this means that only fluid media enter the patient's body, thus protecting the patient from gaseous (such as air) embolism.

[0295] In some embodiments, the rigidification device of the present invention may include a plurality of separate pouches extending longitudinally along the length of the device. For example, see reference to Figure 16O The device 2200o includes four distinct circumferential sacs 2221o distributed around the pressure gap 2212o. In this embodiment, the braided layer is also divided into four longitudinally flat braids 2209o, each located radially outward from the sac 2221o. In other embodiments, the braided layer may include a tubular braid (similar to the following reference) wrapped around the sac 2221o. Figure 67(As described above). Furthermore, the outer layer 2201o and the inner layer 2215o are connected by a separator 2236o. In some embodiments, the separator 2236o may be formed from elements of the outer or inner layers 2201o, 2215o (e.g., it may be a continuous element of one or both of 2201o and 2215o). In some embodiments, the separator 2236o may be configured to help maintain the wall thickness. When pressure is applied to the pressure gap 2212o, the bladder 2221o expands to push the flat braid 2209o toward the outer layer 2201o.

[0296] In some embodiments, refer to Figure 16L The pressure rigidification device described in this invention does not include the innermost layer (e.g., the innermost layer having reinforcing elements). Instead, the rigidification device 2200l may include an outer layer 2201l, a gap layer 2206l, a braided layer 2209l, and a flipped or tubular bladder 2221l (with a pressure gap 2212l). The tubular bladder 2221l may be configured to be positioned around an internal device (e.g., a mirror 2291). When the pressure gap 2212l is filled with a pressurized medium, the bladder 2221l may expand toward the mirror 2291 and the braided layer 2209l. It should be understood that any feature described herein with respect to a vacuum rigidification device may be replaced or substituted with any feature described with respect to a pressure rigidification device.

[0297] In some embodiments, see Figure 92 The distal tip 9229 of the braided layer 9209 can be coupled to the pouch layer 9221 of the pressure rigidification device, such that the tip of the braid and the pouch layer 9221 are part of the same coupling. This advantageously ensures that the tip of the braid will not puncture the pouch layer 9221. In some embodiments, the distal tip 9229 of the braided layer 9209 can extend further than the end of the pouch layer 9221 to further ensure that the sharp tip does not interfere with the pouch layer 9221.

[0298] In some embodiments, the rigidification device of the present invention may incorporate a tool or working channel. The working channel may be designed not to significantly increase the bending stiffness of the rigidification device. (See also...) Figures 17A-17CIn one embodiment, the rigidification device 500 may include a working channel 555 extending therethrough. The working channel 555 may include a central cavity 571z (e.g., for a working element to pass through) formed by alternating telescopic tubular portions, which locally neck or taper from a larger diameter end 569z to a smaller diameter end 570z. Each portion may be connected to a lower layer of the wall (e.g., a sliding layer 513 on the innermost layer 515) at discrete locations or anchor points 568z, and is otherwise free to move. When the rigidification device 500 bends, the smaller diameter end 570z may move within the larger diameter end 559z of an adjacent portion to allow the working channel 555 to bend. The working channel 555 may be located within the wall of the rigidification device 500, for example, in a radial gap 511 between the sliding layer 513 and the first braided layer 509 (and thus may also be located below the radial gap layer 507, the second braided layer 505, the radial gap layer 503, and the outermost layer 501). The working channel 555 can therefore be positioned within the sealed vacuum (or pressure chamber) of the rigidification device 500. In some embodiments, the working channel 555 itself may be located within the sealing bag or layer 572 to ensure no vacuum or pressure leakage path. In other embodiments, these portions may include a sliding seal located therebetween to ensure no vacuum or pressure leakage path. In some embodiments, such as Figure 17D As shown, alternatives to the large-diameter portion 525a and the small-diameter portion 525b can be used instead of tapered portions. During bending on the rigidification device 500, the smaller-diameter portion 525b can move within the larger-diameter portion 525a. The working channel can be placed within the sealed volume formed by layers 501 and 515, or it can be placed outside the sealed volume, for example, on top of layer 501.

[0299] refer to Figures 18A-18B In some embodiments, the rigidification device 7800 may include a helical working channel 7855 surrounding a portion of the elongated body 7803z of the rigidification device 7800. For example, the working channel 7855 may be helical at an angle of 40-50 degrees relative to the longitudinal axis of the device 7800, such as approximately 45 degrees. When the rigidification device 7800 bends, the helical working channel 7855 may advantageously deform into a curved path without resisting bending and / or forcing the path length to adjust along its length. The working channel 7855 may include a proximal port 7840z integrated into the handle 7831 and a distal port 7841z formed to the end of the tip 7833z of the rigidification device 7800 (through which the working tool can be withdrawn). The helical working channel 7855 may be located above the outermost layer 7801 and below the outermost layer 7801 (e.g., Figures 18A-18B As shown, for clarity, the outer layer 7801 has been removed, or further located within the wall layer (e.g., under the woven layer).

[0300] refer to Figures 19A-19B In some embodiments, the rigidification device 4500 may include a plurality of working channels 4555 spiraling around its outer side. For example... Figures 19A-19B As shown, the working channels 4555 can, for example, form a spiral shield surrounding the rigidification device 4500. In some embodiments, the working channels 4555 can collectively form a second rigidification element, which can be rigidified separately from the internal rigidification device 4500. Due to the relative movement of the various spiral working channels 4555, the second rigidification element can advantageously be highly flexible. In some embodiments, the working channels 4555 can include thin flexible rings and / or thin flexible sheaths to include the working channels 4555 in a circular cross-section. In some embodiments, the device 4500 can further include a steerable distal tip 4547, for example, to assist in placing tools extending through the working channels 4555.

[0301] refer to Figures 20A-20B In some embodiments, the rigidification device 8000 may include a rigid elongated body 8003z having a plurality of working channels 8055a-d (e.g., 1-10, 3-5, or 4-5 working channels) extending along its central cavity 8020 to a tip 8033z. Throughout the procedure, the working channels 8055a-d can be used for a variety of different tools. For example, one of the working channels 8055a-d may be used for a catheter with a camera and lighting, another for traction, another for cutting, another for suction, etc. The elements extending along the working channels 8055a-d can be interchanged throughout the procedure. In some embodiments, the rigid elongated body 8003z may be disposable, while the tools may be cleanable and / or sterilizable. In some embodiments, the rigidification device 8000 may further include a passive or active linkage 8004z.

[0302] refer to Figure 21 In some embodiments, the rigidification device 8100 may include a first working channel 8155a and a second working channel 8155b. The first working channel 8155b may extend along the central cavity 8120 (or within the wall of the elongated body 8103z) to the distal end 8133z. The second working channel may similarly extend along the central cavity 8120 or within the wall of the elongated body 8103z, but may exit from the side of the elongated body 8103z near the distal portion 8102z (e.g., before the linkage 8104z). Exiting the tool channel 8155b near the distal portion advantageously limits its interference with the steering or bending of the linkage 8104z.

[0303] refer to Figure 22 In some embodiments, tool 7942z may be specifically designed for use with the working channel of the rigidification device described in this invention. Tool 7942z may include a flexible shaft 7943z and an expandable non-damaging tip 7944z. The non-damaging tip 7944z may be an expandable bladder or a nickel-titanium alloy housing surrounded by foam. In some embodiments, the expandable tip 7944z may be configured to retract (e.g., with a sheath) for delivery via the working channel and self-expand after the sheath is withdrawn and placed through the working channel. The size of the non-damaging tip 7944z may be set, for example, not to fill the lumen of the gastrointestinal tract, so as to avoid contact with the walls of the gastrointestinal tract. Tool 7942z may also have a flexible ring 7945z connected to the tip 7944z or the shaft 7943z. In some embodiments, the ring 7945z may be connected to an endoscopic clip (typically used to close various defects in the gastrointestinal tract) to provide traction during ESD procedures. The user can provide traction to the clip by longitudinally sliding the shaft 7943z. The expandable, non-damaging tip 7944z advantageously allows the tool 7942z to advance freely before the rigid device without fear of causing injury or getting stuck in the gastrointestinal tract. By hooking the flexible ring 7945z onto the clamp, the tool 7942z can achieve good traction through the simple back-and-forth movement of the flexible shaft 7943z.

[0304] Any rigidification device described in this invention may have one or more distal portions having a design different from the main elongated body of the rigidification device. For example, such as Figure 23 As shown, the rigidification device 5500 may have a main elongated body 5503z and a distal portion 5502z. Only the distal portion 5502z, only the main elongated body 5503z, or both the distal portion 5502z and the main elongated body 5503z may be rigidified as described in the invention (e.g., by vacuum and / or pressure). In some embodiments, one portion of 5502z and 5503z is activated by pressure, while the other portion is activated by vacuum. In other embodiments, both portions 5502z and 5503z are activated by pressure or vacuum, respectively.

[0305] refer to Figure 24In some embodiments, the distal portion 5702z may include a rigid braid that differs from the braid of the main elongated portion 5703z. For example, in one embodiment, the braid angle in the distal portion 5702z relative to the longitudinal axis may be greater than the braid angle in the main elongated body 5703z. For example, the braid angle in the distal portion may be 40 degrees, while the braid angle in the main elongated body may be 20 degrees. The braids may slightly overlap and be bonded with a flexible adhesive. These designs can provide greater bending flexibility to the distal portion 5702z than to the main elongated portion 5703z in a non-rigid state. For example, a more flexible distal tip can advantageously prevent twisting and dragging at the tip (caused by the fixed braid end), and / or can advantageously provide flexibility during navigation through body cavities to prevent damage to anatomical structures. In another embodiment, the braid angle in the distal portion 5702z relative to the longitudinal axis may be smaller than the braid angle in the main elongated body 5703z. This can make the distal portion 5702z more rigid relative to the main elongated body 5703z in a rigid state. For example, greater rigidity in the distal portion 5702z can advantageously provide a stable platform for moving or transporting medical devices via the central cavity and removing them from the distal end of the rigidification device 5700.

[0306] refer to Figure 25 In some embodiments, the distal portion 5802z may include a plurality of passively activated linkages 5804z. Each linkage 5804z may be connected together at one or more pivot points and may advantageously provide deterministic bending (i.e., bending in a specific and predetermined direction). Additionally, the linkages 5804z may advantageously provide torsional rigidity to the distal portion 5802z while providing high flexibility for bending. The linkages 5804z may be passively activated, for example, by flexure activation when the device 5800 moves within an anatomical structure. The distal portion 5802z may include, for example, 1-100 linkages 5804z, such as 1, 2, 4, 6, 8, 10, 16, 20, 30, or 40 linkages 5504z. In some embodiments, the linkages 5804z may be formed from passively cut flextures, such as laser-cut tubes or supports.

[0307] refer to Figure 26 In other embodiments, the remote portion 7602z may include a plurality of linkage devices 7604z, which are actively controlled, for example, by a cable 7624, for steering the rigidification device 7600. The device 7600 is similar to the device 5800, except that it includes a cable 7624 configured to control movement of the device. Although Figure 26The cable 7624 is not shown passing through the rigid elongated body 7603z (i.e., having an outer wall 7601, a braided layer 7609, and an inner layer 7615), but the cable 7624 may extend through it in any manner as described elsewhere in the invention. In some embodiments, one or more layers of the rigid elongated body 7603z may extend into the distal portion 7602z. For example, as... Figure 26 As shown, the inner layer 7615 may extend into the distal portion 7602z, e.g., it may be located radially inside the linkage 7604z. Similarly, any additional layers from the rigid proximal portion (e.g., braided layer 7609 or outer layer 7601) may extend into the distal portion 7602z and / or be located radially inside the linkage 7604z. In other embodiments, none of the layers in the rigid elongated body 7603z extend into the distal portion 7602z. The linkage 7604z (and any linkages described herein) may include a cover 7627z thereon. The cover 7627z may advantageously make the distal portion 7602z undamaged and / or smooth. The cover 7627z may be a membrane, such as expanded PTFE. Expanded PTFE may advantageously provide a smooth, low-friction surface with low flexural resistance but high torsional resistance.

[0308] Figure 27A -E illustrates another exemplary remote portion 4302z, which includes a plurality of linkage devices 4304z, for example, actively controlled via cable 4324, for achieving steering of the rigid device. In some embodiments, such as Figures 27A-27E As shown, the pivot of the linkage 4304z can be involute, similar to the teeth of a gear, to reduce local contact resistance. Cable 4324 can be positioned within a cable guide (e.g., a sleeve or coil) that extends the length of the rigidification device. In some embodiments, cable 4324 (and the cable guide) can extend within the wall of the rigidification device. The cable guide advantageously ensures that tensile loads are carried through the cable guide rather than by the wall of the rigidification device, so that the structure of the wall does not adversely deflect when a load is applied to the linkage 4304z. In some embodiments, the cable guide and cable 4324 can have excess length to account for bending of the rigidification device. For example, this excess length can be woven or coiled within the wall of the rigidification device. Furthermore, cable 4324 can pass through holes and / or grooves in the linkage 4304z (e.g., see...). Figure 27CThis allows the device to remain free to float within the wall, while simultaneously maintaining its free float (thus illustrating the bending of the rigidification device). When cable 4324 is activated, linkage 4304z pivots relative to each other, thereby providing steering for the distal portion of the rigidification device. Activation of linkage 4304z and cable 4324 for steering can be achieved via actuators (e.g., field motors, electrically activated (thermal) nickel-titanium-nobelium wires, proximal actuators (typically stainless steel, tungsten, or composite materials), hydraulic devices, and / or EAP (electro-activated polymer)). This steering mechanism can advantageously improve clinical usability. Furthermore, this steering allows devices positioned via a central lumen (e.g., an endoscope or guidewire) to be steered toward the desired anatomical location and to more easily reach that location.

[0309] When the cable is used to turn the distal portion, the cable (which may or may not be in the cable guide) can pass through the wall of the rigidification device described in this invention in a variety of different ways. Figure 28-39B An exemplary construction of a rigidification device with a cable guide is shown (for clarity, in...). Figure 28-39B (Some wall layers are omitted). For example... Figure 28 A rigidification device 6200 is shown, having a cable 6224 extending within a cable guide 6299 within an outer radial gap layer 6207 (and thus between a braided layer 6209 and an outer layer 6201). In some embodiments, each of the cable 6224 and the cable guide 6299 may be positioned approximately equidistantly around the circumference (i.e., approximately 90 degrees apart when four cables are used). In other embodiments, one or more of the cable 6224 and the cable guide 6299 may be closely grouped together (e.g., within the same quadrant) rather than separated from each other. Furthermore, in some embodiments, the cable 6224 and / or the guide 6299 may be asymmetrically distributed around the circumference of the rigidification device 6200.

[0310] Figure 29 A rigidification device 6300 is shown, in which cable 6324 and cable guide 6399 are located within an inner radial gap layer 6311 (and thus between braided layer 6309 and inner layers of the rigidification device, such as bladder 6321). For example, when pressure is applied to pressure gap 6312, bladder 6321 can push braided layer 6309, and braided layer correspondingly pushes outer layer 6301, while braided layer 6309 does not compress or otherwise impact cable 6324. Similarly, cable 6324 and cable guide can be positioned equidistantly or asymmetrically around the circumference of rigidification device 6300.

[0311] refer to Figure 30In some embodiments, the rigidification device 6400 may have a cable 6424 and a cable guide 6499 that are at least partially separated from the pressurized or vacuum area. For example, as Figure 30 As shown, the tubular bladder layer 6421 may surround the pressure gap 6412. Some or all of the cables 6424 and cable guides 6499 may be located in the gap 6407 between the inner layer 6415 and the braided layer 6409, and circumferentially adjacent to the tubular bladder layer 6421. Advantageously, in this configuration, both the cables 6424 and the cable guides 6499 are minimally affected by the pressure of the bladder layer 6421, and substantially do not provide additional stacking height or thickness to the wall.

[0312] refer to Figure 31 In some embodiments, the rigidification device 6500 may include a plurality of circumferentially spaced tubular bladders 6521, such that each cable 6524 and cable guide 6599 can be fitted into a gap 6507 between adjacent tubular bladders 6521.

[0313] refer to Figure 32 The rigidification device 6600 is similar to the device 6500, except that the cables 6624 and guides 6699 are grouped in pairs to reduce the number of tubular bladders 6621 required (e.g., there may be two tubular bladders 6621 and two pairs of cables 6624 and guides 6699 between them).

[0314] refer to Figure 33 The rigidification device 6700 is similar to device 6500, except that each tubular bladder 6721 includes a tubular braided layer 6709 surrounding it (i.e., unlike device 6500 which has a single braided layer 6509). When a pressurized medium is supplied to the pressure gap 6712, the bladder 6721 can expand to compress each individual tubular braid 6709, which can then expand to compress the inner layer 6715 and the outer layer 6701. Alternatively, not all bladders can be pressurized simultaneously (e.g., only one or two), allowing the device to be rigidified only around a circumferential portion. This can generate stiffness only along a portion of the device while still allowing flexibility in other portions, enabling the device to exhibit preferential motion under deflection loads.

[0315] refer to Figure 34In some embodiments, the rigidification device 6800 may include strips of braided layer 6809 (i.e., flat braided fabric rather than tubular braided fabric). Each strip of braided layer 6809 and each cable 6824 and cable guide 6899 may be located within radial gap 6807. Furthermore, the strips of braided layer 6809 may alternate with the cables 6824 / 6899 to minimize the wall thickness of the rigidification device 6800. A bladder 6821 may be located radially outside the strips of braided layer 6809 and the cables 6824 / guides 6899. When a pressure medium is supplied to pressure gap 6812, the bladder 6821 may push the strips of braided layer 6809 radially inward toward the innermost layer 6815 to rigidify the device 6800. In other embodiments, the sac 6821 may be located radially inside the strips of the braided layer 6809 (and the cable 6824 / guide 6899) ​​and is configured to push the strips of the braided layer 6809 toward the outer layer 6801.

[0316] In some embodiments, refer to Figure 35 Cable 6924 and cable guide 6999 can be positioned to extend along the central cavity 6920 of rigidification device 6900.

[0317] In some embodiments, refer to Figure 36 Cable 7024 and cable guide 7099 may be located radially outside of outer layer 7001. Cable 7024 and guide 7099 may be located, for example, within sheath 7009z, which may extend only along cable 7024 or may completely surround outer layer 7001. Guide 7099 may be minimally confined within sheath 7009z to allow free bending during movement of device 7000 (e.g., depending on whether guide 7099 is located inside or outside the center of rigidification device 7000 when rigidification device 7000 bends, thus curling or extending to its full length).

[0318] refer to Figure 37 In some embodiments, cable guides 7199 (which have one or more cables) may be coiled around the outer side of the outer layer 7101 of the rigidification device 7100. Additional cable guides may also be coiled around it. In some embodiments, cable guides 7199 may be coiled around other layers of the rigidification device 7100, such as the inner layer.

[0319] refer to Figures 38A-38BIn some embodiments, the cable guide 7299 (which has one or more cables) and the tubular element 7210z may be alternately coiled around the inner layer 7215 (i.e., such that the cable guide 7299 and the tubular element 7210z form a substantially single layer along the length of the rigidification device 7200). The tubular element 7210z may include an outer tubular braid 7209 with an inner tubular bladder 7221. When a pressurized medium is supplied to the pressure gap 7212, the bladder 7221 may expand to press the tubular braid 7209 outward, and the tubular braid 7209 may push the outer layer outward (not shown for clarity).

[0320] refer to Figures 39A-39B The rigidification device 7300 can be similar to device 7200, except that only the cable guide 7399 and the tubular capsule 7321 can be coiled around the inner layer 7315 within the gap 7311 (note that, for clarity, the cable guide 7399 and the tubular capsule 7321 are...). Figure 39B (Not shown in the image). The braided layer 7309 can be radially wound around the gap 7311. When a pressure medium is supplied to the tubular bladder 7321, the bladder 7321 can expand to push the braided layer 7309 toward the outer layer 7301 (for clarity, ...). Figure 39A (Not shown in the image).

[0321] It should be understood that, Figure 28-39B The cable configuration described herein can be used for any number of cables (e.g., 1, 2, 3, 4, 5, 6, 8, 12, or 16 cables). Furthermore, the cables can be used to steer any tip or rigidification device and / or to steer any distal portion (e.g., portions with linkages or different braid angles). Additionally, the cable guides described in this invention can be round (for round cables), flat, rectangular (for flat strip tension elements), or combinations thereof. Furthermore, in some embodiments, other steering elements can be used to supplement the cables (e.g., pneumatic elements, hydraulic elements, shape memory alloys, EAP (electroactive polymers), or motors). Even if the force available for steering is significantly lower than the force required for rigidification of the nested system, intentionally separating the steering-required elements from the rigidification-required elements allows the structure to exhibit continuously high rigidification performance as a function of length.

[0322] Furthermore, it should be understood that, Figure 28-39B The described cable construction and arrangement can be similarly applied to the arrangement of working channels or other cavities (e.g., inflation cavities for airbags) within rigidification devices.

[0323] refer to Figure 40A-40DIn some embodiments, the distal portion 5902z may include a series of linkages 5904z (active or passive) specifically designed to be rigidified by applying pressure or vacuum. For example, linkages 5904z may be connected to each other via pivot points 5928z (e.g., line pivot points). Each pivot point 5928z may allow bending between linkages in one degree of freedom. Further, linkages 5904z may be arranged alternately, with every other linkage connected to a pivot point 5928z, the pivot point 5928z being positioned at a 90-degree angle to the preceding linkage. Each linkage 5904z may have cutouts 5975z extending from the pivot point 5928z at its proximal and distal ends to allow bending relative to each other. Further, each linkage 5904z may be connected to an adjacent linkage 5904z via a corresponding tension member 5930z. The tension member 5930z can be fixed relative to a linkage and can be at least partially movable within the track 5931z of an adjacent linkage (e.g., within the track 5931z of linkage 9504Z). Movement of the linkage 5904z allows the tension member 5930z to elongate when outside the curve and shorten when inside the curve during bending of the rigidification device. Furthermore, the proximal portion 5902z can include two sliding clamps 5932z attached to the tension member 5930z along opposing axes (i.e., 90 degrees apart). The two tension members 5930z extend from each sliding clamp 5932z to the distal end of the distal portion 5902z. As the distal portion 5902z bends, one cable element of each sliding clamp 5932z shortens and one cable element of each sliding clamp 5932z lengthens, resulting in circumferential movement of the sliding clamps 5932z. When a vacuum or pressure is applied, the sleeve compresses the sliding clamp 5932z against the surface of the track 5931z. The surfaces of the sliding clamp 5932z and the track 5931z can be smooth, rough, or toothed. This compressive force locks the sliding clamp 5932z in a position relative to the linkage 5904z, thereby fixing the position of the tension member 5930z and making the distal portion more rigid in its current shape. Additional rigidification linkages and / or engagements are described in International Patent Application PCT / US2018 / 042946, filed July 19, 2018, entitled “DYNAMICALLY RIGIDIZING OVERTUBE”, now PCT Publication No. WO2019 / 018682, the entire contents of which are incorporated herein by reference.

[0324] refer to Figures 41A-41BIn some embodiments, the distal portion 6002z may include a linkage device 6004z (active or passive) disposed on a portion 6007z, which is rigidified by vacuum or pressure, as further described herein (i.e., situated on a rigidified wall having an inner layer 6015, a pressure gap 6012, a bladder 6021, a braided layer 6009, and an outer layer 6001). Placing the linkage device 6004z on the rigidified portion can provide the advantages of a linkage system (e.g., bending flexibility and torsional rigidity), as well as a directional or deterministic bending end that can be rigidified when the remaining structure is rigidified. Alternatively, the linkage device may be located radially inward of the rigidified portion. Figure 41B As shown, the cable 6024 in the cable guide 6099 can extend through the linkage 6004z to provide optional active steering of the linkage 6004z.

[0325] See Figure 89 In some embodiments, the distal portion 8907z may include a linkage 8904z located radially inside the portion 8907z, which is rigidified by vacuum or pressure, as described herein. For example, the linkage 8904z (and the corresponding cable 8924) may be placed radially inside the inner layer 8915 (and therefore also the pouch 8921, braided layer 8909, and outer layer 8901). When radially inside the inner layer 8915, the linkage 8904z can help the inner layer 8915 (e.g., a coil-wound tube) resist collapse. Furthermore, in this embodiment, the distal portion of the inner layer 8915 extending co-exists with the linkage 8904z may be thinner and / or more flexible than the proximal portion of the inner layer 8915 not extending co-exists with the linkage 8904z. A thinner and / or more flexible distal portion of the inner layer 8915 can provide enhanced maneuverability, flexibility, and bendability at the tip.

[0326] In the remote portion 8907z (or Figures 41A-41B In one exemplary use of the distal portion 6002z, when the rigid portion 8907z is in a flexible configuration, the linkage 8904z and cable 8924 can be used to steer the rigid device. Conversely, when the rigid portion is in a rigid configuration, movement of the linkage 8904z can be prevented, thereby holding the linkage 8904z in a fixed shape. In some embodiments, portion 8907z may be individually rigidizable relative to the proximal portion of the rigid device.

[0327] refer to Figure 42AIn some embodiments, the distal portion 6102z may include a series of linkages 6104z (active or passive) sealed within a thin layer of material 6108z (e.g., made of an elastomer, PVC, or PEEK). The linkages 6104z and the thin layer of material 6108z may be located, for example, above a braided layer 6109 (i.e., radially outward from the braided layer 6109) and may remain continuous with the coil-wound tube 6101 of the main elongated body 6103z. In this embodiment, when pressure or vacuum is applied to the gap 6112, the braided layer 6109 may be pressed by the bladder 6121 against the coil-wound tube 6101 in the main elongated body 6103z and against the linkage sheath 6108z in the distal portion 6102z for rigidification. The linkage sheath 6108z is supported by the linkages 6104z, enabling it to resist the pressure of fabric expansion. This design advantageously provides rigidification and linkages while maintaining a low wall thickness and / or diameter. The remote portion 6102z may include, for example, a cable 6124 extending within a cable guide to activate the linkage 6104z.

[0328] In some embodiments, the rigid structure can be turned from within the walls of the rigid structure, and optionally without any connecting parts. Figure 42B A cross-section of the pressure-rigidification structure 2500 is shown, in which a cable guide 2599 is placed in a pressure gap 2512 and can be connected to an inner layer 2515. A cable 2524 extends from the cable guide 2599 into a distal portion 2502z and is anchored to the inner layer 2515 at an anchor point 2568. Pulling the cable 2524 will cause the distal portion 2502z (the distal end of the cable guide 2599) to deflect. In some embodiments, the cable guide 2599 may be omitted, and the rigidification device 2500 will bend along its entire length when the cable 2524 is pulled. In some embodiments, the device 2500 may be configured to have a distal portion 2502z that has a lower bending stiffness than the proximal elongated body 2503z (as described in the invention, for example by changing the braid angle or using a more flexible reinforcing element in the inner or outer layer), such that the distal portion 2502z bends more than the body 2503z. Cable guide 2599 and cable 2524 may be located between pouch 2521 and braid 2509 or between braid 2509 and outer layer 2501. Cable guide 2599 and / or cable 2524 may be attached to outer wall 2501. Alternatively, in a vacuum-rigidified structure, cable guide 2599 and cable 2524 may be located between inner layer and braid or between braid and outer layer. In some embodiments, in the portion where cable 2524 is not within cable guide 2599, the braid in pouch 2521 and braid 2509 may be omitted, leaving only inner and outer layers 2515, 2501, or only the outer layer or only the inner layer.

[0329] refer to Figures 43A-43C In some embodiments, the distal portion 4602z may include an active deflection segment 4646. The deflection segment 4646 may include a strip or ridge extending therethrough, which, when activated, provides bending only in one or more predetermined directions. The active deflection segment 4646 can be deflected into a predetermined shape, for example, using one or more cables, bladders, drawstrings, and / or introduced wires. The active deflection segment 4646 can thus provide bending of the rigidification device 4600 in a fixed location and in a fixed direction. In some embodiments, markers (e.g., non-transmissive markers) may be positioned within or proximal to the active deflection segment 4646 to indicate where bending will occur and / or in which direction the active deflection segment 4646 will bend. Using the active deflection segment 4646 to bend the rigidification device 4600 may be advantageous, for example, when bending is required without assistance from anatomical structures (i.e., when the anatomical path of the rigidification device 4600 is not predetermined or constrained by anatomical structures). For example, during a transseptal mitral valve procedure, this bending may help create a bend in the open or relatively unconstrained space between the inferior vena cava (IVC) and the atrial septum. The active bending segment 4646 can be configured to be rigidified (i.e., by pressure or vacuum) as described in this invention, thereby securing or locking the active deflection segment 4646 in the bending configuration. Furthermore, in addition to the active deflection segment 4646, the rigidification device 4600 may include a steerable distal portion 4647 (e.g., having a linkage mechanism). As described elsewhere in this invention, the steerable distal portion 4647 can be used to point or orient the distal end of the rigidification device 4646 in a desired direction (e.g., via cables and / or along four axes).

[0330] In some embodiments, the rigidification device described herein can be configured to present a predetermined shape without the use of an internal steering mechanism (e.g., without cables, bladders, or wires). See also Figure 86A-86FSystem 8604y includes a preformed filament 8605y (e.g., a superelastic nitinol filament) and a rigidification device 8600. The preformed filament 8605y can be preformed into various shapes, such as preformed shapes for specific brain, visceral, or cardiac indications. The preformed filament 8605y can be more rigid than the rigidification device 8600 in a flexible configuration, but less rigid than the rigidification device 8600 in a rigid configuration. Therefore, when the rigidification device 8600 is in a flexible configuration, the preformed filament 8605y can bend the rigidification device 8600 into the shape of the preformed filament 8605y, but when the rigidification device is in a rigid configuration, the preformed filament 8605y can take on the shape of the rigidification device 8600. Because the preformed filament 8605y is hyperelastic, it can easily change shape (e.g., when the rigidification device 8600 is in a rigidification configuration) while still restoring its preformed shape (e.g., when the rigidification device 8600 is in a flexible configuration).

[0331] Figure 86B-86F An exemplary method for using system 8604y is shown. For example... Figure 86B As shown, the rigidification device 8600 can be placed inside the body (in any shape) and rigidified (e.g., by applying pressure or a vacuum). Figure 86C As shown, the preformed filament 8605y can then be inserted into the central cavity of the rigidification device 8600. Because the rigidification device 8600 is in a rigid configuration, the preformed filament 8605y will take on the shape of the rigidification device 8600. Figure 86D As shown, the rigidification device 8600 can then be made flexible (e.g., by releasing pressure or vacuum), thereby allowing the preformed filament 8605y to regain its preformed shape. Figure 86E As shown, as the preformed filament 8605y recovers its shape, the rigidification device 8600 will take on the shape of the preformed filament 8605y. The rigidification device 8600 can then be rigidified into this preformed shape. In step 86F, when the preformed filament 8605y is in the rigid structure, it can be removed by pulling the preformed filament 8605y proximally back through the device 8600.

[0332] Advantageously, a single rigidification device 8600 can be configured to present a variety of different predetermined shapes in situ using multiple different pre-formed filaments 8605y. In some embodiments, multiple pre-formed filaments 8605y can be tried until the shape fits the desired indication without removing the rigidification device 8600 from the body. In some embodiments, the pre-formed filaments 8605y can be reused (e.g., autoclaved after use), while the rigidification device 8600 can be used only once.

[0333] System 8604y can be advantageously used, for example, for coronary artery catheterization, for access to head and neck vessels from the aortic arch, or for access to the bile and pancreatic ducts during, for example, ERCP (endoscopic retrograde cholangiopancreatography).

[0334] Any rigidification device described herein may include one or more separate rigidification sections. For example, refer to Figures 44A-44C In some embodiments, the rigidification device 900 may have individual vacuum / pressure chambers 975a-d (e.g., four vacuum or pressure chambers) along its length. Each chamber 975a, b, c, d may have its own vacuum / pressure conduit 927a-d extending to it for individual rigidification of chamber 975a, b, c, d. Pressure seals 929 may extend between each chamber and / or at the distal end. In some embodiments, the rigidification device 900 having individual rigidification chambers 975a, b, c, d may include a steerable distal portion 902z (e.g., having a linkage as described elsewhere in the invention). Cables 924a-d controlling the steerable distal portion 902z may be managed using cable guides 999 (e.g., at least one, e.g., 1-4 cable guides 999 may be present in each vacuum chamber 975). In some embodiments, as Figure 44B As shown, cables 924a-d, cable guides 999a-d, and / or vacuum / pressure lines 927a-d can extend within the radial gap 911 between the innermost layer 915 and the braided layer 909 (and thus also below the outermost layer 901). Figure 44C In other embodiments shown, cables 924a-d, cable guides 999a-d, and / or vacuum / pressure lines 927a-d can extend within the central cavity 920 of the rigidification device 900. In the use of the rigidification device 900, any chambers 975a-d in a flexible state can be turned or deflected in the direction of cable tension, while the rigidified chambers 975a-d will remain in their position without deflection. Advantageously, this design allows chambers 975a-d to alternately be in vacuum / pressure and / or turning directions to form a variety of complex shapes and provide navigation within the anatomical structure with minimal loops.

[0335] Any rigidification device or distal portion described herein may have a distal tip thereon, which is configured to closely follow the diameter of the mirror of the device inserted therein without generating significant resistance or friction. For example, Figure 103A-103BAn exemplary distal tip 10332y is shown, which is axially reinforced and radially expandable. As shown, tip 10332y may include a tapered outer shell 10333y. Furthermore, tip 10332y may include an inner shell 10334y, which includes an annular ring 10335y and a plurality of protrusions 10336y extending distally from the annular ring 10335y. For example, there may be 10-40 protrusions 10336y, such as 15-30 protrusions 10336y. Protrusions 10336y may taper gradually, thus having a wider proximal end 10337y and a narrower distal end 10338y. Furthermore, the proximal end 10337y of protrusion 10336y may have a cutout 10339y therein (e.g., on the outer surface), thereby forming a movable hinge at each protrusion 10336y. The movable hinge advantageously allows the protrusion 10336y to bend radially outward.

[0336] In some embodiments, the outer shell 10333y may be made of a low-hardness material, while the inner shell 10334y may be made of a high-hardness material. For example, the outer shell 10333y may be made of thermoplastic elastomer or silicone and / or may have a hardness of 50A or lower, while the inner shell 10334y may be made of polypropylene, polytetrafluoroethylene, high-density polyethylene, or low-density polyethylene. In some embodiments, the material used for the inner shell 10334y may be a low-friction material to allow it to slide easily relative to the mirror.

[0337] The tip 10332y can be configured to engage with the rigidification device at its proximal end and conform to the mirror body at its distal end. In use, the protrusion 10336y can move between various diameters at its distal end (e.g., at the movable hinge). This can advantageously allow the tip 10332y to closely conform to various mirror diameters or features and / or conform to the mirror when it bends, thereby reducing the gap between the mirror and the tip 10332y and reducing the chance of tissue being trapped in the gap between the distal end of the tip 10332y and the mirror. In some embodiments, when the tip 10332y is used with the mirror, the resulting gap can be less than 0.04”, for example, less than 0.01”. Furthermore, the rigidity of the protrusion 10336y can further advantageously prevent the distal end of the rigidification device from inverting.

[0338] In some embodiments, the tip 10332y can be injection molded. For example, a rigid material of the inner shell 10334y can be molded first, and then a flexible material of the outer shell 10333y can be molded thereon.

[0339] In some embodiments, the lower hardness material of the outer shell 10333y may additionally or alternatively be placed along the interior of the inner shell 10334y.

[0340] In some embodiments, the distal portion of the rigidification device of the present invention may include elements for local tissue stabilization, such as a suction element, an airbag element, or a cage element. For example, see reference to Figures 45A-45D In one embodiment, the rigidification device 600 may include an airbag 666 and an airbag inflation chamber or tube 667 extending into the airbag 666. Figure 45B-45D As shown (for clarity, the outer layer has been removed in 6B-6C), the airbag inflation tube 667 can extend alongside the working channel 655 (and thus reside within the radial gap 611 between the sliding layer 613 and the first braided layer 609). Figure 45B-45C As shown, the inflation tube 667 can be configured to include an auxiliary tube bundle loop 668 (service loop, i.e., such as...) that can vary in length. Figure 45B The straightening shown or as Figure 45C (To achieve greater flexibility), to accommodate the bending of the rigidification device 600. In some embodiments, the airbag inflation tube may be spirally wound about its axis to accommodate bending. In some embodiments, the vacuum rigidification device may include an airbag inflation tube located between the innermost layer and the braid, between the braid and the outer layer, radially inward of the inner layer or radially outward of the outer layer. In some embodiments, the pressure rigidification device may include an inflation cavity in a pressure gap, between the airbag and the braid, between the braid and the outer layer, radially inward of the inner layer or radially outward of the outer layer. For example, the inflation cavity may be positioned similarly to that described in the present invention with respect to working channels and / or cables.

[0341] Figure 90A-90BAnother exemplary rigidification device 9000 is shown, comprising an airbag 9066 and one or more hollow inflation tubes 9067 (for clarity, the outer sheath, braided layer, and anti-clogging element have been removed from 90A). The hollow inflation tube 9067 extends between the braided layer 9009 and the inner layer 9015. Furthermore, the device 9000 includes a tip fitting 9008y located within the airbag 9066 and proximal to the distal ring of the outer tube or the tip 9009y. The outer layer 9001 and the braided layer 9009 may terminate at the tip fitting 9008y and may be attached to the tip fitting 9008y, for example, by adhesive, thermal bonding, or compression fitting. The inner layer 9015 may extend radially inward from the tip fitting 9008y to the distal ring of the outer tube or the tip 9009y. Furthermore, the proximal ends of the inner layer 9015 and the airbag 9066 may be connected to the distal ring 9009y of the outer tube (e.g., by adhesive, thermal bonding, or compression fitting). The tip fitting 9008y may include a groove 9010y or hole configured to allow the cavity of the hollow inflation tube 9067 to pass through and reach the interior of the airbag 9066. The groove 9010y may include an anti-clogging element 9011y at its distal end, such as a piece of fabric, breathable material, or other permeable material, to prevent the airbag 9066 from obstructing flow into or out of the inflation cavity 9067, even if the airbag wall collapses.

[0342] As another example, Figures 46A-46B An exemplary vacuum tip 5354 for use with a rigidification device is shown. The vacuum tip 5354 may include a circumferential array of vacuum holes 5358 on its distal end face 5359. Furthermore, the array of vacuum holes 5358 may be connected to a vacuum line 5356 extending along the rigidification device (e.g., within or adjacent to the layered walls of the rigidification device). The vacuum line 5356 may be connected to a vacuum source such that, when activated, a vacuum is supplied through the vacuum line 5356 to each hole 5358 in the array (e.g., through an annular inlet 5319z). Therefore, aspiration can be provided on the distal end face 5359 of the tip 5354 (i.e., the distal end face of the rigidification device). This aspiration can be used, for example, to aspirate tissue (e.g., for stabilization of interventional procedures, such as nipple cannulation, for access to the pancreatic duct or bile duct). This aspiration can also be used, for example, for endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR).

[0343] In some embodiments, the vacuum tip 5354 may be located just distal to the steering portion of the rigidification device, which can be advantageously used to orient the vacuum tip 5354 in a desired direction. Furthermore, in some embodiments, a tool (e.g., a guidewire or mirror) may pass through the central cavity 5320z of the tip 5354 and through the array of vacuum holes 5358 to allow procedures to be performed when suction is activated.

[0344] refer to Figures 47A-47B In some embodiments, the vacuum tip 5254 may include a semi-annular array of holes 5238 at the farthest end face 5259, instead of a circumferential array of holes.

[0345] refer to Figures 48A-48B In some embodiments, the vacuum tip 5454 may have an angled distal face 5459 (e.g., at an angle of 30-80 degrees relative to the longitudinal axis of the tip 5454, such as 30, 45, 60, 70, or 80 degrees). The angled distal face can advantageously assist in accessing anatomical structures at an angle for easier attachment to local surfaces.

[0346] The vacuum tip described herein can advantageously provide suction without causing "red-out" of the endoscope lens, because suction can occur locally (e.g., at orifice 5358) rather than at the lens of the endoscope. Therefore, the endoscope can provide visualization of tissues even when suction is applied.

[0347] In some embodiments, the vacuum tip of the present invention may include a metallized portion and / or a wire with a common connector, such that the vacuum tip can conduct electric current. This current can be used, for example, to cut or coagulate the aspirated tissue.

[0348] In some embodiments, the vacuum tip of the present invention can be used with a standard endoscope or endoscopic device that does not have rigidity.

[0349] Any rigidification device described in this invention can be used with a handle configured to allow manual operation and / or activation of the device.

[0350] Figures 49A-49D An exemplary handle 1031 is shown. Handle 1031 includes an activation element 1048 in the form of a button, configured to activate a vacuum or pressure (the button is located in...). Figure 49A and 49C It is displayed as closed in the middle. Figure 49B and 49D (Displayed as open). Furthermore, the flow path within the handle 1031 may include a vacuum or pressure inlet port 1049 configured to connect to a vacuum or pressure source, a rigidification device port 1050 connected to the rigidification device via an outlet 1073z, and a vent port 1051 connected to the atmosphere. (As shown in the image). Figure 49AAs shown, when the activating element 1048 is in the distal "off" position (i.e., the rigidification vacuum or pressure of the rigidification device is shut off), the vent port 1051 and the rigidification device port 1050 are connected to each other, thereby releasing any rigidification pressure or vacuum into the air and causing the rigidification device to be in a flexible configuration. Figure 49B As shown, when the activation element 1048 is in the proximal "on" position (i.e., causing the vacuum or pressure to the rigidification device to be turned on), the rigidification device port 1050 and the vacuum or pressure inlet port 1049 are connected to each other, thereby providing pressure or vacuum to the rigidification device to allow the device to rigidify. In some embodiments, the handle 1031 may be configured to engage with the rigidification device at the engagement region 1053 (e.g., to an internal coil wound tube engaged with the rigidification device). Figure 49C As shown in Figure -D, the handle includes a status indicator element 1067z to indicate whether the rigidification device is in a flexible or rigid configuration. In this embodiment, the status indicator 1067z is configured such that the text "On" is displayed when the button is in the "On" position, and the text "Off" is displayed when the button is in the "Off" position. In other embodiments, the status indicator may be a symbol, color, light, or movement indicator.

[0351] The activation element of the rigidification device handle described in this invention can be a button, switch, toggle switch, slider, threaded joint, squeeze handle, or stopcock. Furthermore, the activation element can be planar, sector-shaped, or omnidirectional. The indicator element can include text, lights, or elements that rotate with the flow of vacuum or pressure. For example, see reference... Figures 50A-50B In some embodiments, the activation element 1548 may be a slider element. The activation element 1548 may include a connecting element 1574z (e.g., a hollow tube or snap-fit ​​element) configured to slide on a handle. An indicator element 1567z may be built into the slider (e.g., indicating "rigid" when the slider is in one position and "flexible" when the slider is in another position). Figures 51A-51C You can see a similar slider activation element 1648 (this one is orthogonal).

[0352] In some embodiments, one or both of the activation element and the indicator element may be located on a separate element, rather than on the handle. For example, the activation element may be positioned along a vacuum or pressure line between the handle and a vacuum or pressure pump, may be actuated by a foot pedal, may be on the endoscope tube, on the endoscope axis, or may be clipped to the patient's bed. In some embodiments, the activation element may be detachable from the handle, but may be clipped to the handle during part of the procedure. For example, Figures 52A-52CAn activation element 1448 is shown, which includes a connection mechanism 1452 (e.g., a C-clamp) for detachable connection to a handle 1431. Separating the indicator element and / or activation element from the handle can advantageously allow the actuator and indicator to be seen more clearly (i.e., without obstruction by human anatomy), and / or can allow the actuator and indicator to be more easily controlled / used by another person (e.g., a surgical assistant).

[0353] Figures 53A-53D A handle 1131 is shown, designed to allow manipulation of the rigidification device, but it does not include an activation element or indicator element. The handle 1131 includes a large stop or flange 1161 at its distal end, which serves as an insertion stop for the handle 1131 (i.e., preventing the handle 1131 from moving into the anatomical structure) and as a surface that the operator can push against during use. The rigidification device can be connected at a mating region 1153. Furthermore, the handle 1131 may include an input device 1165 from a remote activation element, which is connected to an output device 1173z of the rigidification device.

[0354] In some embodiments, the handle used with the vacuum rigidification device may include a vent port to allow air to be supplied to the rigidification device when no vacuum is available (i.e., when the rigidification device is in a flexible configuration). For example, Figures 54A-54B A handle 1231 is shown with a slide valve activation element 1248 that reciprocates in one direction to activate the vacuum in the rigidification device and can reciprocate in the opposite direction to deactivate the vacuum or pressure. When the vacuum or pressure of the rigidification device is deactivated, the activation element 1248 can be vented through a vent port 1251. The activation element 1248 can be positioned on the vacuum or pressure line 1232 leading to the handle, for example, 4-8 inches away from the handle, such as 6 inches. Figure 54A As shown, the slide valve with end button indicator element 1267z can indicate whether the rigidification device is in a flexible configuration (as shown) or a rigid configuration (when pushed in the opposite direction).

[0355] refer to Figures 55A-55C The activation element 1348 may be a rotary valve (e.g., connected to a handle or elsewhere as described in this invention), and the sliding indicator 1367z on the rotary valve activation element 1348 may indicate vacuum or pressure on (e.g.) Figure 55A and 55C (as shown) or shut off and ventilate (as shown) Figure 55B (As shown).

[0356] In some embodiments, a handle used with a vacuum rigidification device may include a mechanism configured to automatically lock the handle in a vacuum or ventilated configuration. For example... Figures 56A-56GA handle 7531 for use with a vacuum rigidification device 7500 is shown. The handle 7531 includes a handle body 7515z configured to attach to the rigidification device 7500. The handle 7531 also includes an activation element 7548 in the form of a switch ring for providing vacuum to the rigidification device 7500. The switch ring activation element 7548 may include a magnet 7522z configured to engage with a proximal magnet 7523z (e.g., ...). Figure 56D (as shown) or the distal magnet 7524z (as shown) Figure 56E (As shown) When the switch ring magnet 7522z engages with the near-end magnet 7523z, the vacuum feed line 7532 in the handle 7531 is disconnected from the vacuum port 7550 of the rigidification device, and both the rigidification device and the vacuum are vented to or opened to the atmosphere (as shown). Figure 56F (As shown). When the switch ring magnet 7522z engages with the distal magnet 7523z, the vacuum feed line 7532 in the handle 7531 is connected to the vacuum port 7550 of the rigidification device to provide it with a vacuum (as shown). Figure 56G (As shown). Advantageously, magnets 7522z, 7523z, and 7524z can lock the switch ring 7548 in a vacuum or ventilated configuration, thereby preventing potential harm to the patient in unintended configurations (e.g., attempts to move the device 7500 through anatomical structures when it is in a rigid configuration, where the device might damage the anatomical structures). In some embodiments, magnet 7522z may be an iron-containing material, while magnets 7523z and 7524z may be magnets, and vice versa. Figures 56A-56B As shown, the handle 7531 may also include a user grip 7521z for user hand gripping, having a handle cover 7525z configured to cover the vacuum feed line 7532 in the handle 7531. Furthermore, the vacuum feed line 7532 may be directly connected to the switch ring activation element 7548. The vacuum feed line 7532 may have a helical or coiled shape below the handle cover 7525, which allows the switch ring activation element 7548 to move proximally and distally without being restricted in its movement by the vacuum feed line 7532. The helix of the vacuum feed line 7532 can range from 30 degrees to approximately 1440 degrees. For example, 90 degrees (e.g., ...) Figure 56C(As shown, for clarity, the handle cover has been removed) 180 degrees, 360 degrees, and 720 degrees. The handle cover 7525z can be designed such that it covers the entire vacuum feed line 7532, even when the helix is ​​completely around the handle 7531. The handle 7531 may also include a stop flange 7561 to prevent the handle 7531 from moving into anatomical structures (e.g., the stop flange can prevent the device from passing through the anus or through oral bite protection); a proximal handle port 7526z for inserting a mirror or other working tool through it; and / or an indicator element 7567z. The indicator element 7567z is a band that is only visible when the switch ring activation element 7548 is in the distal position. The indicator element 7567z may have a different color and / or brightness value than the rest of the handle, preferably a color that forms a sharp contrast and is visible even in reduced light conditions. For example, the handle 7531 may be white, and the indicator element 7567z may be medium to dark blue. The indicator element 7567z can also have a different texture than the rest of the handle 7531. For example, it can have raised dots or crosshairs. This allows the doctor to easily feel the status of the handle 7531.

[0357] Figure 82A -J illustrates another exemplary handle 8231 for a vacuum rigidification device having a mechanism configured to automatically lock the handle in a vacuum or ventilated configuration. Handle 8231 includes a handle body 8215z configured to attach to the rigidification device. Handle body 8215z may include a distal connector 8281z, a valve body 8280z, an exchange ring activation element 8248, and a proximal end 8282z. The distal connector 8281z is configured to attach to the rigidification device and includes a stop flange 8261 thereon. The proximal end 8282z includes a port 8226z for allowing a mirror or other working tool to pass through. The exchange ring activation element 8248 may be configured in a first direction (e.g., Figure 82G As shown, it rotates around the valve body 8280z to set the rigidification device in a rigid configuration, and in the second direction (such as...). Figure 82H (As shown) Rotate to set the rigidification device in the flexible configuration.

[0358] Depending on the rotational position of the ring activation element 8248, the ring activation element 8248 may include a pair of exchange ring magnets 8222z configured to engage with either a first magnet 8223z or a second magnet 8224z of the valve body 8280z. When one of the exchange ring magnets 8222z engages with the first magnet 8223z, the vent port in the vacuum feeder 8232 is sealed (against the seal 8297z), and the vacuum feeder 8232 is fluidly connected to the vacuum port 8250, resulting in a rigidification device exhibiting a rigid configuration (such as...). Figure 82G(As shown). When another exchange ring magnet 8222z mates with the second magnet 8224z, the vacuum feed line 8232 and vacuum port 8250 are open to the atmosphere, and the rigidification device is in a flexible configuration (as shown). Figure 82H (As shown). In some embodiments, the vacuum port 8250 can be entirely formed within the valve body 8280z, thereby eliminating the need for a separate conduit.

[0359] Similar to the handle 7531, magnets 8222z, 8223z, and 8224z can lock the exchange ring 8248 in either a vacuum or ventilated configuration, thus preventing potential injury to the patient if the rigidification device is located in an unintended and / or partial configuration (i.e., the handle can be bistable, allowing the activation element 8248 to be fully positioned in either a vacuum / rigid configuration or a ventilated / flexible configuration only). Furthermore, because the rotational movement of the ring 8248 is perpendicular to the linear movement used for the procedure performed via the rigidification device, the two movements (activation and movement of the rigidification device within the body) can be separated, further reducing the possibility of unintentional activation (and thus improving safety). Additionally, by rotating the exchange ring 8248 between positions, the user can easily grasp the handle body 8215z with one hand to activate and deactivate the vacuum, while the other hand remains free.

[0360] In some embodiments, actuation can be locked by using a pair of magnets only on the valve body 8280z and on or for the ring activation element 8248 using a magnetic material (i.e., instead of a pair of exchange ring magnets 8222z). In this embodiment, the magnetic material on the ring activation element 8248 can be configured to interact with the first magnet 8223z and the second magnet 8224z according to the positioning of the ring 8248.

[0361] The switching ring activation element 8248 may further include an indicator element 8267z, which indicates whether the activation element 8248 is rotated to a rigid position. Figure 82I ) or flexible ( Figure 82J The configuration is as follows. Furthermore, in some embodiments, indicator elements 8267z may be positioned at different locations around the circumference (e.g., every 180 degrees) to ensure that the user can see the status of the rigidification device regardless of the rotational position of the handle 8231 in the user's hand. The exchange ring activation element 8248 may further include a plurality of radially extending protrusions 8283z configured to enhance the user's grip.

[0362] In some embodiments, the handle used with the pressure rigidification device may include a pressure gap inlet and a vent gap inlet. Figures 57A-57CAn exemplary handle 6231 connected to a pressure rigidification device 6200 is shown. The handle includes a pressure gap inlet 6293 and a vent gap inlet 6223. The pressure gap inlet 6293 is connected to a pressure gap 6212 (via a pressure line 6294). The vent gap inlet 6223 (which can extend through the handle to exit at its sides) is connected to a gap 6206 around the braided layer 6209 (between the bladder 6221 and the outermost layer 6201). The vent inlet 6223 can open to the atmosphere, while the gap inlet 6293 can be connected to a pressure source (e.g., activated by an activation element). The handle 6231 can be used, for example, to operate... Figure 16G The described device 2200g. In some embodiments, an accessory may be added to the gap inlet 6293 so that the handle 6231 can be used to operate the device 2200i, as referenced. Figure 16I As stated above.

[0363] In some embodiments, such as Figure 91 As shown, the handle 9131 used with the pressure rigidification device may include an annular bladder adapter 9112y, and an annular outer adapter 9113y located around the bladder adapter 9112y. Adapters 9112y and 9113y may be configured to secure the layers of the rigidification device within the handle 9131 and may be attached (e.g., bonded or thermally welded) to the handle 9131. Therefore, as Figure 91 As shown, the outer surface of the innermost layer 9115 can be bonded to the inner surface of the handle body 9115z, which advantageously ensures that the handle body 9115z does not extend into the cavity 9114y of the handle 9131. The outer surface of the bladder 9121 can be bonded to the inner surface of the bladder adapter 9112y, which advantageously provides the maximum annular area for the flow of inflation fluid or gas between the bladder 9121 and the innermost layer 9115, thereby increasing / decreasing the activation / deactivation rate. Bonding the outer surface of the bladder 9121 to the bladder adapter 9112y further ensures that when pressure is applied to the pressure gap 9112, its compression bonding area increases, thereby increasing the bonding strength. Furthermore, the inner surface of the braided layer 9109 can be bonded to the outer surface of the bladder adapter 9112y, which advantageously ensures that any sharp ends of the braided layer 9109 are away from the bladder 9121. Finally, the outer surface of the outer layer 9101 can be bonded to the inner surface of the outer layer adapter 9113y.

[0364] In some embodiments, the handle used with the pressure rigidification device may include a pre-filled pressure medium. For example, in Figures 58A-58EAn exemplary handle 7431 connected to a pressure rigidification device 7400 is shown. The handle 7431 includes a handle body 7415z and a lever / operating lever 7411z, which can be activated to supply a pressure medium, such as pressure medium pre-filled or stored in a fluid chamber 7412z of the handle 7431, to the rigidification device 7400. The fluid chamber 7412z may be bounded by, for example, a rolling diaphragm 7416z. The lever / operating lever 7411z may include teeth 7476z that engage with a rack 7414z of a piston 7413z. When the lever / operating lever 7411z moves toward the handle body 7415z, the piston 7413z may move distally toward the rolling diaphragm 7416z of the fluid chamber 7412z. When the rolling diaphragm 7416z is pushed distally, it forces the pressure medium from chamber 7412z through gap inlet 7493 to pressure gap 7412 outside bladder 7421 for rigidification (and air or other fluids can also escape from around the braided layer via vent port 7423). In some embodiments, handle 7431 may include a locking mechanism (e.g., a click-to-open / click-to-close mechanism, such as that in a ballpoint pen) with a spring and feeler 7778z, configured to lock handle / lever 7411z onto body 7415z, thereby locking the rigidification device 7400 into a rigid configuration. Similarly, when handle / lever 7411z is pushed back onto body, handle / lever 7411 can be released, and fluid can be moved back into fluid chamber 7412z via inlet 7493.

[0365] In some embodiments, the handle 7431 may further include a pressure-reducing valve 7417z located between the fluid chamber 7412z and the overflow chamber 7418z. When the pressure in the fluid chamber 7412z reaches a preset maximum pressure (e.g., 5 atmospheres), the pressure-reducing valve 7417z can open to allow fluid to be introduced into the overflow chamber 7418z. The fluid chamber 7412z may be overfilled during manufacturing such that the valve 7417z is always open upon initial activation of the handle / operating lever 7411z, ensuring that the handle 7431 is calibrated to the desired pressure. An exemplary method of filling the fluid chamber 7412z may include: (1) connecting a handle 7431 to a filling fitting that is connected to a tube leading to a pressure system; (2) evacuating the handle to remove air through the filling fitting; (3) while maintaining the vacuum, introducing water, deionized water (DI), brine, oil, or other incompressible fluid into the system through the filling fitting; and (4) crimping and sealing the tube distal to the pressure fitting (by mechanical crimping or melting the tube, etc.), and then removing the pressure fitting, leaving the crimped / sealed tube in the handle.

[0366] Any handle described in this invention can incorporate pressure indication features. For example, the handle can have a pressure gauge. The handle may include features such as a piston, which can be displaced to give a visual indication that the device is pressurized. The handle may have flip-up or rotational features to display different colors; for example, it may display a green dot at atmospheric pressure and a red dot when rigidified. In some embodiments, the visual indication can be seen during fluoroscopic examination.

[0367] If, for some reason, the handle channel is blocked, any of the aforementioned pressure-rigid handles may have an emergency venting feature. The emergency venting feature may allow, for example, a cutting device to disrupt its pressure chamber. For example, the emergency venting feature could be a valve (e.g., a swabable valve) on the distal side of the handle, such that if the valve is actuated, the device will release pressure and thus derigidify.

[0368] Any rigidification device described in this invention may include a built-in camera, lighting equipment, etc., to provide airborne imaging. In some embodiments (as follows) Figure 63 As shown), the camera and lighting can be located at the distal tip of the device. In other embodiments, such as Figure 59 As shown, the rigidification device 8200 may include a camera 8234z and a lighting device 8235z mounted on an elongated body 8203z near the distal end 8202z of the device (e.g., near the steering linkage device 8204z).

[0369] In some embodiments, the rigidification device of the present invention may be configured as a guide (i.e., an instrument for introducing a flexible device, such as a guide sheath for interventional cardiology). For example, see reference to Figure 60 The rigidification device 8700 may include a rigid elongated body 8703 having a tapered distal tip 8733z. The device 8700 may further include a hemostatic valve 8749z and / or a flushing line 8748z.

[0370] The woven fabric described in this invention may include a mesh, woven material, tape, or fabric, or alternatively, the aforementioned materials. In some embodiments, the woven fabric may be nonwoven (i.e., fibers at different angles may not be above or below each other, but rather located on separate layers that do not intersect). Similarly, the woven fabric may be replaced by a support or a structure (e.g., a metal structure) cut from a hypodermic cannula.

[0371] In some embodiments, the rigidification device described in this invention can be configured to be mounted on the side of a mirror or other instrument (e.g., rather than requiring the mirror / instrument to be inserted into the proximal end of the rigidification device). For example, such as Figures 61A-61BAs shown, the rigidification device 400 can be separated along its length (i.e., longitudinally separated through the wall from the proximal end to the distal end). Furthermore, the connecting feature 444 can connect the partition walls together. In some embodiments, the connecting feature 444 can be reusable. For example, the connecting feature 444 can be a series of magnets that can engage ( Figure 61A To hold the rigidification device 400 together, and to allow for disengagement from the engagement. Figure 61B This provides a side passage for the mirror / instrument. Other exemplary reusable connection features include zippers, interlocking male-female zipper structures, or reusable straps. In some embodiments, connection feature 444 may be permanent and non-reusable, such as permanent tape or adhesive.

[0372] In some embodiments, the vacuum and pressure multilayer system of the present invention can be used to provide stiffness for non-cylindrical or non-tubular structures. For example, the system of the present invention can be used to manufacture airbags that take on a desired shape when pressurized and / or rigidified. Such structures can be flexible structures, yet simultaneously contain elements exhibiting high circumferential stiffness, such as filaments (stretched or compressed) or thin fiber strands (stretched).

[0373] In some embodiments, the rigidification device of the present invention may include proximal and distal seals within the innermost layer to create a space between the mirror or instrument and the innermost layer to maintain lubrication.

[0374] In some embodiments, the rigidification devices described herein can be used in conjunction with other versions of a product. For example, an endoscope may include the rigidification mechanism described herein, and the rigidification devices may include the rigidification mechanism described herein. They can be used together to create a nested system that can advance one after another, such that one element always remains rigid, thereby reducing or eliminating loops (i.e., they can create a nested system that advances sequentially).

[0375] Example nested system 2300z Figure 62As shown. System 2300z may include an outer rigidification device 2300 and an inner rigidification device 2310 (here configured as a rigidification mirror), which are axially movable concentrically or non-concentrically relative to each other. The outer rigidification device 2300 and the inner rigidification device 2310 may include any rigidification features described in this invention. For example, the outer rigidification device 2300 may include an outermost layer 2301a, a braided layer 2309a, and an inner layer 2315a, the inner layer 2315a including a coil wound thereon. The outer rigidification device 2300 may be configured, for example, to receive a vacuum between the outermost layer 2301a and the inner layer 2315a to provide rigidification. Similarly, the endoscope 2310 may include an outer layer 2301b (e.g., wound with a coil), a braided layer 2309b, a capsule layer 2321b, and an inner layer 2315b (e.g., wound with a coil). For example, endoscope 2310 can be configured to receive pressure between the capsule 2321b and the inner layer 2315b to provide rigidity. Furthermore, air / water channels 2336z and working channels 2355 can extend through the internal rigidification device 2310. Additionally, the internal rigidification endoscope 2310 may include a distal portion 2302z with a camera 2334z, an illumination device 2335z, and a steerable linkage device 2304z. A cover 2327z may extend over the distal portion 2302z. In another embodiment, the camera and / or illumination device may be transported in separate components (e.g., the camera and illumination device may be bundled together in a conduit and transported along the working channel 2355 and / or an additional working channel to the distal end 2333z).

[0376] An interface 2337z may be provided between the inner rigidification device 2310 and the outer rigidification device 2300. The interface 2337z may be a gap, for example, having a dimension d of 0.001-0.050 inches (see...). Figure 62 (e.g., 0.0020 inch, 0.005 inch, or 0.020 inch thick). In some embodiments, interface 2337z may be low-friction and have, for example, a powder, coating, or laminate structure to reduce friction. In some embodiments, a seal may be present between the inner rigidification device 2310 and the outer rigidification device 2300, and the intermediate space may be pressurized, for example, with fluid or water, to create a hydrostatic bearing. In other embodiments, a seal may be present between the inner rigidification device 2310 and the outer rigidification device 2300, and the intermediate space may be filled with small balls to reduce friction.

[0377] The inner rigidifying device 2310 and the outer rigidifying device 2300 are movable relative to each other and alternately rigidify to transmit bending or shaping along the length of the nested system 2300z. For example, the inner device 2310 can be inserted into a cavity and bent or turned into a desired shape. Pressure can be applied to the inner rigidifying device 2310 to engage the braided elements and lock the inner rigidifying device 2310 in the configuration. The rigidifying device 2300 (e.g., in a flexible state) can then be advanced on the inner device 2310. When the outer rigidifying device 2300 reaches the tip of the inner device 2310, a vacuum can be applied to the rigidifying device 2300 to engage and lock the layers, thereby fixing the shape of the rigidifying device. The inner device 2310 can be switched to a flexible state, advanced, and the process repeated. Although the system 2300z is described as including a rigidifying device and an inner device configured as a mirror, it should be understood that other configurations are possible. For example, the system may include two outer tubes, two conduits, or a combination of an outer tube, a conduit, and a mirror.

[0378] Figure 63 Another exemplary nested system 2700z is shown. System 2700z is similar to system 2300z, except that it includes a cover 2738z connected to the inner and outer rigidification devices 2710, 2700. Cover 2738z may be, for example, low-stiffness and thin-walled to ensure elasticity and tensile strength. Cover 2738z may be rubber, such as polyurethane, latex, or silicone resin. Cover 2738z can protect the interface / radial gap between the inner and outer devices 2710, 2700. Cover 2738z can prevent contaminants from entering the space between the inner and outer tubes. Cover 2738z can further prevent tissue and other substances from being trapped in the space between the inner and outer tubes. Cover 2738z can extend to allow the inner device 2710 and outer device 2700 to move independently of each other within the elastic limits of the material. Cover 2738z can be coupled or attached to the rigidification devices 2710, 2700 in a manner that is always under minimal slight tension. This embodiment can be wiped clean from the outside. In some embodiments, cover 2738z may be configured to "roll" seal, as disclosed, for example, in US6447491, the entire contents of which are incorporated herein by reference.

[0379] Figures 64A-64BAnother exemplary nested system 9400z is shown. In this system 9400z, the outer rigidification device 9400 includes steering and imaging (e.g., similar to a mirror), while the inner device only includes rigidification (although it may include additional steering elements as described elsewhere in the invention). Thus, the outer device 9400 includes the linkage device or other steering device 9404z disclosed in this invention, a camera 9434z, and a lighting device 9435z. The outer device 9400 may further include a central channel 9439 (e.g., a cavity, such as a working channel therein) for accessing the inner device 9410. In some embodiments, a bellows or pipe loop can connect the channel 9439z to the cavity of the inner device 9410. Similar to other nested systems, at least one of the devices 9410, 9400 can be rigidified at one time, while the other can conform to that rigidification and / or move through the anatomical structure. Here, the outer device 9400 can guide the inner device 9410 (the inner device 9410 is in...) Figure 64A The diagram shows the device retracted relative to the external device 9400, and... Figure 64B The middle part extends generally flush with the outer device 9400. Advantageously, the system 9400z can provide a smooth outer surface to avoid compressing the anatomical structure and / or the fluid inlet between the inner and outer devices 9410, 9400. The steering mechanism on the outer device 9400 also provides additional leverage for the steering of the tip. Furthermore, due to the larger diameter of the outer device 9400 and its ability to accommodate a larger camera, it can contribute to better imaging capabilities.

[0380] Figures 65A-65H An exemplary use of the nested system 2400z as described in this invention is shown. Figure 65A In this configuration, the inner rigidification device 2410 is located within the outer rigidification device 2400, while the distal end of the inner rigidification device 2410 extends outside the outer rigidification device 2400. Figure 65B In this process, the distal end of the internal rigidification device 2410 is bent in a desired direction / orientation and then rigidified (e.g., using vacuum or pressure as described in this invention). Figure 65C In this configuration, the outer rigidification device 2400 (in a flexible configuration) is advanced (including over the curved distal portion) on the rigidified inner rigidification device 2410. Once the distal end of the outer rigidification device 2400 has been sufficiently advanced over the distal end of the inner rigidification device 2410, the outer rigidification device 2400 can then be rigidified (e.g., using vacuum or pressure as described in this invention). Figure 65D In this configuration, the internal rigidification device 2410 can then be converted to a flexible state (e.g., by removing the vacuum or pressure as described in this invention, and by slackening the steering cable to allow easy movement of the tip), and can be advanced and pointed / oriented / steered as needed. Optionally, in Figure 65DIn this process, the inner rigidification device 2410 can be actively steered (manually or by computational control) when it is exposed, minimizing the load on the rigidified outer tube. Minimizing the load on the outer rigidification device 2400 makes it easier for the tube to maintain its rigidified shape. Once the inner rigidification device 2410 is rigidified, the outer rigidification device 2400 can transition to a flexible state and advance on it (e.g., Figure 65E (As shown). Then you can do as follows: Figure 65F The -H option indicates that the process should be repeated.

[0381] In some embodiments, upon completion Figure 65A In the sequence shown in -H, the third rigidification device can slide past the first two rigidification devices (2400, 2410) and be rigidified. Rigidification devices 2400 and 2410 can then be withdrawn. Finally, a fourth rigidification device can be inserted through the lumen of the third tube. This fourth rigidification device can have a larger diameter and more features than rigidification device 2410. For example, it can have a larger working channel, more working channels, a better camera, or a combination thereof. This technique allows two smaller tubes (preferably more flexible and maneuverable) to be inserted into the body while still ultimately allowing a larger tube to be inserted for therapeutic purposes. Alternatively, in the above example, the fourth rigidification device can be a conventional endoscope known in the art.

[0382] In some embodiments, upon completion Figure 65A In the sequence shown in -H, the outer rigidification device 2400 can be rigidified, after which the inner rigidification device 2410 can be removed. For example, the rigidification device 2410 can be a "navigation" device, including a camera, lighting equipment, and a distal steering portion. The "navigation" device 2410 can be well-sealed, making it easy to clean between procedures. A second inner device can then be placed within the rigidified outer device 2400 and advanced beyond the distal end of the outer device 2400. The second inner device can be a "treatment" tube, including elements such as a camera, lighting equipment, water, suction, and various tools. The "treatment" device may lack the steering portion or rigidification capability, thus providing additional space within the body of the treatment tube for including other features, such as tools used to perform treatments. Once in place, the tools on the "treatment" tube can be used to perform treatments within the body, such as mucosal resection or dissection in the human gastrointestinal tract.

[0383] In another embodiment, after completion Figure 65A Following or during the sequence indicated by -H, a third device may be inserted into the interior of the inner tube 2410. The third device may be a rigid instrument and / or an endoscope.

[0384] Although the external rigidification device of the nested system described in this invention is generally considered to be rigidified by vacuum and the endoscopic rigidification device is considered to be rigidified by pressure, the opposite may be true (i.e., the external rigidification device may be rigidified by pressure and the internal rigidification device may be rigidified by vacuum), and / or both may have the same rigidification source (pressure and / or vacuum).

[0385] Although the inner and outer components of a nested system are often described as including an integrated rigid element, the rigid element can be separate (e.g., to allow relative sliding between the imaging mirror element and the rigid element).

[0386] The rigidification devices of the nested system described in this invention can be designed such that, when assembled, the inner rigidification device is substantially unable to rotate within the outer rigidification device. For example, the outer surface of the inner rigidification device can have longitudinal ridges and grooves forming keys. The inner surface of the outer rigidification device can have corresponding ridges and grooves that match the same features in the inner and outer rigidification devices.

[0387] One or both of the rigidification devices in the nested system described in this invention can be steerable. If both rigidification devices are steerable, an algorithm can be implemented to steer either the flexible and longitudinally moving rigidification device. This algorithm can steer the flexible rigidification device to its desired shape, thereby minimizing the tendency of the moving flexible rigidification device to straighten the rigidification device.

[0388] If one rigidification device of the nested system described in this invention requires a vacuum while the other rigidification device requires pressure, a user control can be constructed in which movement of one relative to the other (outer / inner) involves a toggle switch that switches between a first state and a second state. In the first state, for example, one is pressurized for rigidification while the other is ventilated for flexibility; in the second state, one is ventilated for flexibility while the other is vacuumed for rigidification. The switch can be, for example, a foot pedal or a manual switch.

[0389] In some embodiments, the alternating movement of the nested system described in this invention can be manually controlled. In other embodiments, the alternating movement can be automatically controlled by a computer and / or an electric motion control system.

[0390] The nested systems described in this invention can advantageously possess similar stiffness. This ensures a relatively continuous overall stiffness of the nested systems. The nested systems described herein can be very small to fit a variety of different anatomical structures. For example, for neurological applications, the outer diameter of the system can be between 0.05 and 0.15 inches, such as about 0.1 inches. For cardiological applications, the outer diameter of the system can be between 0.1 and 0.3 inches, such as about 0.2 inches. For gastrointestinal applications, the outer diameter of the system can be between 0.3 and 1.0 inches, such as 0.8 inches. Furthermore, the nested systems described in this invention maintain high stiffness even in small configurations. For example, the change in relative stiffness from a flexible configuration to a rigid configuration can be 10 times, 20 times, 30 times, or even greater. Additionally, the nested systems described herein can advantageously move smoothly relative to each other.

[0391] The nested system described in this invention can advantageously navigate arbitrary paths, or open, complex, or tortuous spaces, and create a series of independent complex shapes. The nested system can further advantageously provide shape propagation, allowing shape memory to be transferred from one element to another. In some embodiments, the two tubes can be periodically placed in a partially or fully flexible state, such that, for example, the radius or curvature of the system increases, and the surrounding anatomical structures provide support for the system. The pressure or vacuum used to rigidify the tubes can be reduced or stopped to place the tubes in a partially or fully flexible state. This momentary relaxation (e.g., 1-10 seconds) allows the system to find a shape that more closely matches the anatomical structures it traverses. For example, in the colon, this relaxation can gently open sharp turns in the anatomy.

[0392] In some embodiments, the stiffness capability of the inner or outer stiffening device can be designed such that the sharp turn formed by the inner stiffening device at its tip gradually opens (constructed to have a larger radius) as it is replicated by the outer stiffening device, because the shape propagates proximally along the outer tube. For example, the outer stiffening device can be designed to have a larger minimum radius of curvature when stiffened.

[0393] The nested system is continuous (i.e., non-segmented), thus providing smooth and continuous movement through the body (e.g., the intestine). This nested system can be disposable and low-cost.

[0394] In some embodiments, the external rigidification device may be a dynamically rigidified outer sleeve (e.g., as described in PCT / US18 / 42946, the entire contents of which are incorporated herein by reference). In some embodiments, the internal rigidification device may be a rigidification system or a commercially available endoscope, such as a 5 mm diameter nasal endoscope. Compared to a duodenoscope, the use of a rigidification and nesting system allows for the use of a smaller endoscope that offers greater flexibility (if desired), greater rigidity (if desired), greater maneuverability, and the ability to articulate with a much smaller radius of curvature.

[0395] In some embodiments, the inner rigidification device of the nested system can be retracted once the target location is reached. The outer rigidification device can remain rigid and can be used for fluorescence imaging by injecting contrast agent through the space of the inner element.

[0396] Radiofrequency coils can be used in any nested system described in this invention to provide a three-dimensional representation of any shape presented by the nested system. This representation can be used to recreate the shape or return to a given point (e.g., for follow-up by a physician after an automated colonoscopy).

[0397] In some embodiments, the nested system described in this invention can be used as a complete endoscope, the internal structure of which carries the payload of the working channel, pressurization line, vacuum line, tip cleaning, and electronic equipment (vision system, ultrasound, X-ray, MRI) for illumination and imaging.

[0398] The nesting system described in this invention can be used, for example, in colonoscopy. This colonoscopy nesting system can reduce or eliminate loops. It eliminates the need for endoscopic reduction. Without loops, the procedure can combine the speed and low cost of sigmoidoscopy with the efficacy of colonoscopy. Furthermore, the colonoscopy nesting system eliminates the need for conscious sedation and its associated costs, time, risks, and facility requirements. Moreover, the surgical skill required for this type of colonoscopy can be significantly reduced by using the nesting system described in this invention. In some embodiments, the nesting system described in this invention can provide automated colonoscopy, wherein the visual system automatically drives the nesting system along the center of the colon while locating polyps. This automated system advantageously eliminates the need for sedation or a physician to perform basic examinations, while allowing the physician to perform subsequent examinations as necessary.

[0399] In some embodiments, the rigidification device (e.g., a nested system) described herein may be controlled by a robot. Figures 93A-93D An exemplary use of the nested system 9300z is shown, similar to... Figures 65A-65H The nested system shown can be controlled or manipulated by a robot (e.g., for rigidification, steering, movement, etc.). Figures 93A-93DAs shown, the external rigidification device 9300 and the internal rigidification device 9310 may terminate together in a common structure, such as a housing 9357. The external rigidification device 9300 can be moved relative to the internal rigidification device 9310 by rotating a disc 9389 mounted on the housing 9357. For example, the disc 9389 may be a pinion, and the external rigidification device 9300 may have a frame 9382 comprising a plurality of small teeth on its exterior. Rotating the disc 9389 against the teeth 9382 can cause the external rigidification device 9300 to advance forward or backward relative to the internal rigidification device 9310. In some embodiments, the possible movement or translation of the rigidification devices 9300, 9310 is limited by the size or design of the housing 9357.

[0400] The housing 9357 may also include additional discs 9371a, 9371b, which can be connected to cables 9363a, 9363b respectively to steer (e.g., bend or deflect) the tip of the internal rigidification device 9310 (and / or the external rigidification device 9300). Other steering mechanisms (e.g., pneumatic, hydraulic, shape memory alloy, EAP (electro-activated polymer), or motor) are also possible. Similarly, in embodiments with different steering mechanisms, one or more discs in the housing 9357 (e.g., discs 9371a, 9371b) can be used to actuate steering.

[0401] Box 9357 may further include bellows 9303a and 9303b, which can be connected to the pressure gaps of the internal rigidification device 9310 and the external rigidification device 9300, respectively. Compression of the bellows 9303a and 9303b drives fluid through the pressure line 9305z, causing a pressure increase in the pressure gaps of the internal rigidification devices 9310 and 9300, thereby rigidifying the rigidification devices 9310 and 9300. Activation of the bellows 9303a and 9303b can be applied sequentially and / or simultaneously. Figures 93A-93D As shown, the box 9357 may include eccentric cams 9374a, b to control bellows 9303a, b. Optionally, as Figure 94A As shown, one or more linear actuators 9316y (e.g., on housing 9357 or on drive unit 9517y) can be configured to actuate bellows 9303a, b. Alternatively, devices 9300, 9310 can be rigidified and derigidified via one or more reservoirs (as described herein) or pressure source 9306Z (e.g., via pressure line 9305Z), as... Figure 94BAs shown. Other mechanisms that cause the internal and external rigidification devices 9310, 9300 to rigidify are also possible. For example, in some embodiments, the cartridge 9357 may include a syringe or other container containing fluid that can be delivered to the internal and external rigidification devices 9310, 9300 to add pressure for rigidification. In some embodiments, the syringe or other container may be used to withdraw fluid from the cartridge 9357, thereby creating a vacuum that can be applied to the internal and external rigidification devices 9310, 9300.

[0402] Refer again Figures 93A-93D The housing 9357 may include a connector 9315y for connection to additional cavities and / or wiring within the internal rigidification device 9310. Connector 9315y may include connections for delivering suction and water to the tip of the internal rigidification device 9310. Connector 9315y may include an electrical connector for connecting a camera mounted at the tip of the internal rigidification device 9310 to an external monitor and / or video processing unit. Connector 9315y may include a mechanical connector connected to a hollow tube (e.g., a working channel) extending to the tip of the internal rigidification device 9310. By including connector 9315y, control of all components of the system 9300z can be performed via housing 9357.

[0403] Disks 9389, 9371a, 9371b and cams 9374a, 9374b (or corresponding bellows) can be accessed from the bottom of box 9357, as... Figure 93B The side view is best shown. Discs 9389, 9371a, 9371b and / or cams 9374a, 9374b may have features such as splines, pins or teeth to transmit torque. These features may allow operation of discs 9389, 9371a, 9371b and / or cams 9374a, 9374b (e.g., via a drive unit).

[0404] Figure 95An exemplary drive unit 9517y is shown that can be used to drive disks 9389, 9371a, 9371b and / or cams 9374a, 9374b. For example, drive unit 9517y may include drive paddle 9519y, which may be aligned with disks 9389, 9371a, 9371b and / or cams 9374a, 9374b of cartridge 9357. Drive paddle 9519y may be driven (i.e., rotated) by one or more motors of drive unit 9517y to transmit torque to disks 9389, 9371a, 9371b and / or cams 9374a, 9374b of cartridge 9357. Drive paddle 9519y may include features 9518y (e.g., splines, pins, teeth, etc.) to transmit torque to disks 9389, 9371a, 9371b and / or cams 9374a, 9374b of cartridge 9357. The drive unit 9517y can be attached to the box 9357, for example, by clips, screws or magnets.

[0405] See Figure 96 In some embodiments, the robot-controlled nested system described herein (e.g., system 9300z) may include a guide 9621y extending along the outer diameter of the outer rigidification device 9600 to allow tools (e.g., surgical or laparoscopic tools) to advance through it. That is, the guide 9621y may allow the tool to be guided along the outside of the outer rigidification device 9600 until the distal end of the tool advances distally past the distal end of the outer rigidification device 9600. The guide 9621y may be, for example, a series of non-damaging rings 9622y. The rings 9622y may be spaced apart from each other along the longitudinal axis such that the rings 9622y will not contact each other even when the outer rigidification device 9600 is deflected to its maximum bending radius. In some embodiments, the rings 9622y may have an inner diameter of about 2-9 mm.

[0406] See Figures 97A-97B The guide 9721y can be, for example, a flat tube attached to one side of the external rigidification device 9700. In the first configuration (e.g.) Figure 97A As shown, the flat tube guide 9721y can rest flat against the outside of the external rigidification device 9700. In a second configuration, the guide 9721y can expand into its tubular shape. The inner diameter of the guide 9721y can be, for example, between 2 mm and 9 mm. For example, the flat tube guide 9721y can take on the second configuration when a tool passes through it. The flat tube guide 9721y may have a series of perforations along its length to allow a tool to be inserted into the cavity of the tube guide 9721y at any of the perforations along the length of the rigidification device 9700. In another embodiment, the guide can be a series of telescopic rigidification devices shaped like a bellows or a combination thereof.

[0407] In some embodiments, a robot-controlled nested system may include more than one guide to provide different placements and / or uses of multiple tools. For example, such as Figure 98 As shown, the external rigidification device 9800 may include two guides 9821y on opposite sides. The guides 9821y may include the same or different designs. More than two guides and associated tools may also be used. In some embodiments, the guides may be located within the volume of an internal rigidification device (e.g., rigidification device 9310).

[0408] like Figure 98 Further, as shown, in some embodiments, the robot-controlled nested system may include an accessory 9823y at its distal end. A guide 9821y may terminate at port 9824y in accessory 9823y (or, if a ring is used for the accessory, the ring may be concentrically aligned with port 9824y when the external rigidification device 9800 is in a straight configuration). As a tool passes through guide 9821y, it may also pass through the corresponding port 9824y, and in some embodiments, it is locked to port 9824y. In some embodiments, two, three, or more tools may be locked in accessory 9823y. Furthermore, in some embodiments, accessory 9823y may include additional ports that can connect to additional tubular structures to provide suction, water, imaging, and / or additional tool access. These additional tubular structures may extend proximally to or through a cassette (e.g., cassette 9357). In some embodiments, these additional tubular structures may be omitted from the interior of the internal rigidification device 9310 because they are incorporated into accessory 9823y. In some embodiments, accessory 9823y may be permanently attached to an external rigidification device 9800, but temporarily attached to an internal rigidification device (e.g., rigidification device 9310) for use during a specific surgical procedure. Accessory 9823y may include a disposable sheath attached thereto. The disposable sheath may be, for example, a thin plastic rigidification device, such as an inexpensive flat rigidification device. The disposable sheath may cover both the internal rigidification device (e.g., device 9310) and the external rigidification device 9800 and be connected to a housing (e.g., housing 9357). The disposable sheath may include a tubular structure that provides features as described herein, such as aspiration, water, and additional tool channels. In some embodiments, accessory 9823y may be configured to rotate about the external rigidification device 9800. For example, a Bowden cable may be mounted outside the external rigidification device 9800 and terminate at the distal end of accessory 9823y and the proximal end of the rigidification device, such as a handle. Rotating the Bowden cable may apply torque within accessory 9823y, causing accessory 9823y to rotate. Accessory 9823y may have a limited range of motion; for example, + / - 90 degrees or + / - 60 degrees.

[0409] Figure 99An exemplary tool 9980 for use with a robot nesting system (e.g., system 9300z) is shown. Tool 9980 may include a housing 9925y, a flexible shaft 9926y, a bending portion 9927y, and an end effector 9928y (e.g., tweezers, grippers, or scissors). The housing 9925y, similar to a nesting system housing (e.g., housing 9357), may have a rotatable disc to control various aspects of tool 9980. For example, rotating the disc may cause the bending portion 9927y to deflect. Another disc may be used to control the end effector 9928y. Furthermore, tool 9980 may include a locking feature 9929y configured to engage with a fitting port (e.g., port 9824y) to lock tool 9980 in place relative to an external rigidification device (e.g., rigidification device 9800). Locking feature 9929y may include, for example, a spring pin configured to engage with a corresponding slot or hole on an end fitting 3060. Other locking mechanisms are also possible (e.g., magnetic locks, electronic locks, torsion locks, notch locks, bayonet locks, etc.).

[0410] In one exemplary use, when tool 9980 is inserted into guide 9821y, it can move distally until it passes through port 9824y, and locking feature 9929y aligns with the inner diameter of port 9824y. In some embodiments, a controller on tool 9980 can reversibly engage with longitudinally locking tool 9980 having end fitting 9823y. Alternatively, tool 9980 can automatically lock into place in fitting 9923y. Besides the lock at fitting 9823y, tool 9980 can otherwise be loosely held or longitudinally floated within guide 9821y.

[0411] refer to Figure 100 and return Figures 93A-93DIn some embodiments, the robotic system (e.g., system 9300z including internal and external rigidification devices 9310, 9300 and box 9357) may be located on a linear slider 10020y. The linear slider 10020y may also include a drive unit 10017y (similar to drive unit 9517y) configured to control the internal and external rigidification devices 9310, 9300. The slider 10020y may allow the internal and external rigidification devices 9310, 9300 to translate together (i.e., simultaneously). In some embodiments, to achieve relative movement between the internal rigidification device 9310 and the external rigidification device 9300, system 9300z may translate in a first direction (forward or backward along slider 10020y) while simultaneously moving the external rigidification device 9300 in a second direction opposite to the first direction using disk 9389 and frame 9382 on the external rigidification device 9300. In other words, in order to advance the internal rigidification device 9310 relative to the external rigidification device 9300, the system 9300z, comprising the two rigidification devices 9300 and 9310, advances along the slider 10020y while retracting the external rigidification device 9300 using the disc 9389 and the frame 9382. Conversely, in order to retract the internal rigidification device 9310 relative to the external rigidification device 9300, the system 9300z, comprising the two rigidification devices 9300 and 9310, can retract along the slider 10020y while advancing the external rigidification device 9300.

[0412] See Figure 100 The linear slider 10020y may also include a second drive unit 10030y configured to control one or more tools (e.g., tool 9980) used with the internal and external rigidification devices. In some embodiments, the first drive unit 10017y and the second drive unit 10030y may translate independently along the linear slider 10020y. One, two, or more tools 9980 may be connected to the drive unit 10030y. The linear slider 10020y advantageously ensures that a tool used with the nested rigidification system remains in place at the distal end of the external rigidification device, even if the external rigidification device is translated. For example, the tool drive unit 10030y may be configured to translate the tool forward when the external rigidification device advances relative to the slider 10020y. Similarly, the tool drive unit 10030y may be configured to retract the tool when the external rigidification device retracts relative to the slider 10020y. This, for example, can ensure that the tool remains locked in an accessory (e.g., accessory 9823y).

[0413] Figure 101A and 101BA top perspective view and a top view view of an exemplary robot system 10100z located on a slider 10120y are shown, wherein a housing 10157 is attached to a drive unit 10117y for controlling nested rigidification devices 10100 and 10110. Two housings 10125y for controlling two different tools 10180 are mounted on a drive unit 10130y. The tools 10180 are inserted via a guide 10121y and locked in a fitting 10123y at a port 10124y.

[0414] Figure 102 An exemplary pivot arm 10231y is shown, which can be connected to a linear slider 10120y, thereby relative to the patient-oriented slider 10120y and the rest of the robotic system (including nested rigidification devices 10100, 10110 and / or tool 10180). Thus, the linear slider 10120y can be positioned vertically, horizontally, or at an angle somewhere in between.

[0415] System 10100z can be used in the following exemplary manner. Box 10157 is attached to internal and external rigidification devices 10110, 10100, and the internal and external rigidification devices 10110, 10100 are advanced into the patient's body (e.g., as shown in the image). Figure 65A (As described in detail in -H). In some embodiments, the internal and external rigidification devices 10110, 10100 are advanced into the patient's colon or upper gastrointestinal tract. The reciprocating motion of the internal rigidification device 10110 and the external rigidification device 10100 is provided by the movement of a disc within a housing 10157 and the translation of the rigidification devices 10110, 10100 along a slider 10120y. Rigidification is achieved by compressing a bellows in the housing 10157. Direction is provided by the disc in the housing 10157. When the physician reaches the site in the body to be operated on, the tool can be inserted through the guide 10121y and locked to the port 10124y. The housing 10125y is then attached to the drive unit 10130y for controlling the tool.

[0416] The drive unit described herein can be connected to a computer (e.g., a computer, tablet, laptop, etc.) for control. The computer communicating with the drive unit may include software that provides a user interface to clinicians to interact with them and control the system and any tools used. Automation, such as computer control via the box and / or drive unit described herein, can be used to make repetitive tasks easier to perform. For example, a program can be developed to automatically move the distal end of a rigidification device in an arc while spraying water. A second arc can then be performed to aspirate water and material from the gastrointestinal tract. This may aid in cleaning the gastrointestinal tract. Programs can be developed to perform the rigidification steps outlined herein sequentially, requiring only input from the operator, such as using a joystick to guide the distal end of the device.

[0417] In some embodiments, the internal and external rigidification devices can be advanced using small step distances (e.g., less than 1 inch) by the robotic system described herein. Small step distances advantageously allow for more precise control over the placement and orientation of the rigidification devices. For example, a user can steer the inner tube in the desired direction, and the rigidification and advance or retraction sequence of the outer tube can be automatically triggered when the inner tube advances a small amount (e.g., 1 / 2, 3 / 4, or slightly less than 1 inch) ahead of the outer tube. In some embodiments, the current small step distance sequence can be overridden when needed. In some embodiments, the robotic system can advance the internal and external rigidification devices using medium step distances (e.g., 1-3 inch step distances) or large step distances (e.g., greater than 3 inches step distances).

[0418] The boxes and / or tools described herein may be disposable or reusable, or used and cleaned within a limited period of time.

[0419] In some embodiments, the linear slider described herein may be U-shaped and have a corresponding U-shaped channel. Alternatively, in some embodiments, the linear slider may be circular and have a corresponding circular channel.

[0420] In some embodiments, the tip of the external rigidification device may include one or more cameras to observe the end effector of the tool used with the robotic system. This can allow the robot system's controller to calculate the relationship between control inputs and effector outputs and adjust accordingly to give the same effector motion, regardless of the tooth path (e.g., regardless of the resistance applied to the tool control cable during bending).

[0421] In some embodiments, the nested rigidification device may include one or more expansion members (e.g., a cage or airbag) at its distal end. Exemplary expansion members are described in PCT / US2017 / 047591 and PCT / US2019 / 034881, the entire contents of which are incorporated herein by reference. Expansion members help center the rigidification device to simplify relative movement and keep tissue away from any camera lens. In some embodiments, the expansion member may expand when the rigidification device to which it is attached is stationary, and may shrink or collapse when the rigidification device to which it is attached moves. In other embodiments, the expansion member may remain expanded throughout the procedure.

[0422] In some embodiments, the rigidification device of the present invention can be configured as a rigidification rod. (See also...) Figure 66 The rod 4900 may include an outer layer 4901, a braided layer 4909, and an inner lamellae 4921. Furthermore, the gaps 4912 within the lamellae may be sealed and filled with, for example, air or water (e.g., to radially push the lamellae 4921 outwards). The outer layer 4901 may be a filament-reinforced layer, such as a coil-reinforced polyurethane tube. The braided layer 4901 may include braided strands 4933 and may have any of the characteristics of other braided layers described in this invention. The inner lamellae 4921 may be made of a low-stiffness elastomer. The rod 4900 may also include a soft and / or tapered, non-damaging tip.

[0423] In some embodiments, the distal end of the inner capsule 4921 may be sealed to the outer capsule 4901, and the rod 4900 may include an inlet located between the outer capsule 4901 and the inner capsule 4921 to provide a vacuum for rigidification. In other embodiments, the distal end of the inner capsule 4921 may be sealed to itself or to an undamaged distal tip, and the proximal end may be configured to have an inlet leading to the interior of the inner capsule 4921 (i.e., radially inward of the inner capsule 4921) to provide pressure rigidification. When pressure rigidification is used, the rod 4900 may further include vent holes at the distal and / or proximal ends to allow air to escape between the inner capsule 4921 and the outer capsule 4901 (thus allowing the capsule 4921 to push the braided layer 4909 completely toward the outer capsule 4901).

[0424] In some embodiments, the outer surface of the outer layer 4901 may be coated to provide a low-friction surface including a hydrophilic coating. In some embodiments, the outer diameter of the rod 4900 may be less than 5 mm, less than 4 mm, or less than 3 mm. For example, the outer diameter may be between 2 mm and 5 mm, such as between 2.5 mm and 3 mm, such as approximately 2.8 mm. In some embodiments, the angle of the braid in the braided layer 4909 may be less than 25 degrees relative to the longitudinal axis of the tube, such as approximately 5-15 degrees. In some embodiments, there may be 10 to 50 strands of yarn, such as 20-40 strands, extending within the braided layer 4909.

[0425] refer to Figure 67 The rod 4900 can be used as a reinforcing wire, for example, in a colonoscopy. In this use, the colonoscope 5091 can be inserted into the patient's colon. If a loop is formed (thus hindering the advance of the colonoscope), the endoscope 5091 can be left in place, the working channel 5055 of the endoscope 5091 can be flushed, water can be applied to the outer surface of the rod 4900 to activate the hydrophilic coating, and the rod 4900 can be inserted through the working channel 5055 in a flexible state (i.e., not rigidified). Once the rod 4900 is fully inserted into the endoscope, such that the distal end of the rod 4900 is flush with the distal end of the colonoscope 5091, a vacuum or pressure can be applied to the rod 4900 (e.g., through the pressure inlet and / or connector 5063z) to rigidify the rod. In some embodiments, pressure or vacuum can be applied to the rod 4900 via a syringe or a locking inlet. The colonoscope 5091 can be advanced relative to the patient on the rod 4900 while keeping the rod 4900 stationary relative to the patient. Vacuum or pressure can be removed to advance or remove the rigid rod 4900.

[0426] Advantageously, the rod 4900 can thus be inserted into the mirror 5091 in a flexible configuration, allowing for easier navigation at turns compared to a standard reinforcing wire (i.e., compared to a fixed rigid reinforcing wire). Furthermore, the rod 4900 can conform to the shape of the annular colon in the flexible configuration while providing the mirror with a rigid track in the rigid configuration. The dynamic transition of the rod 4900 between the flexible and rigid configurations prevents undesirable straightening of the mirror 5091 (which could occur in a standard reinforcing wire). Additionally, the non-damaging tip of the rod 4900 prevents damage to the working channel 5055. The rigid rod 4900 can also be relatively long (e.g., longer than the mirror) without hindering the mirror's navigation, as the mirror moves along the rigid rod 4900. Therefore, the rod 4900 can work with a variety of mirrors, regardless of their length. Similarly, the rod 4900 can have a diameter of 3.2 mm or less, and therefore can work with a variety of endoscopes regardless of their diameter (since most endoscopes have a working channel of 3.2 mm or more).

[0427] The rigidification system and apparatus described in this invention can be used to treat or access many different anatomical locations.

[0428] In one method of use, during a surgical procedure, the rigidification device described in this invention can be introduced into the patient in a flexible configuration. Once the distal end of the rigidification device is positioned to pass through a challenging anatomical structure (e.g., a portion of the anatomical structure that would cause loops or otherwise be difficult to pass through using standard instruments), the rigidification device can be converted to a rigid configuration. Instruments (e.g., endoscopes) can then pass over or through the rigidification device.

[0429] For example, the device described in this invention can be used to navigate the gastrointestinal tract, reach anatomical locations in the stomach, access anatomical locations otherwise obstructed by other organs via the abdomen for interventional endoscopic procedures (including ESD (endoscopic mucosal dissection) and EMR (endoscopic mucosal resection)), for direct cholangioscopy, for endoscopic retrograde cholangiopancreatography, for cardiological applications, for resection or capture of lesions in the gastrointestinal tract, for colonoscopy, for EUS, for access to the lungs, for access to the kidneys, for neurological applications, for treatment of chronic total occlusion, for laparoscopic manual instruments, for access to the contralateral leg, for otolaryngological applications, for esophagogastric and duodenal endoscopy, for transoral robotic surgery, for flexible robotic endoscopy, for transluminal endoscopic surgery with natural orifices, or for altered anatomical conditions. Specific examples are further described below.

[0430] Furthermore, depending on the desired application, the rigidification device of the present invention can have different dimensions. For example, when designed for use in, for example, the gastrointestinal tract, the rigidification device can have an inner diameter of approximately 0.3-0.8 inches (e.g., 0.5 inches), an outer diameter of 0.4-1.0 inches (e.g., 0.6 inches), and a length of 50-200 cm, for example, 75-150 cm. For example, when designed for use in the cardiovascular system, the rigidification device can have, for example, an inner diameter of 0.04-0.3 inches (e.g., 0.2 inches), an outer diameter of 0.06-0.4 inches, and a length of 30-130 cm.

[0431] The rigidification device described in this invention can be used as a jacket for a mirror in at least three different ways: (I) placing the jacket after the mirror reaches its destination; (II) the jacket follows the mirror closely but remains near the tip of the mirror until the mirror reaches its destination; or (III) a point-and-shoot method. Figures 68A-68B An exemplary rigidification device 2000 and mirror 2091 are shown in the figure. For Method I, the endoscope 2091 can be positioned in the desired location within the body using standard techniques, and then the rigidification device 2000 can be advanced proximally until it fully supports the endoscope 2091. For example, to perform a resection in the colon, the surgeon can advance the colonoscope to the target site and then advance the rigidification device almost or completely to the tip of the endoscope. The rigidification device 2000 can then be rigidified. For example, by providing a stable surgical platform, the rigidification device 2000 can advantageously enhance control during colon resection. The rigidification device 2000 can also advantageously facilitate a good connection between the surgeon's hand movement outside the patient and the movement of the endoscope 2091 along its axis and at its tip (so-called "1:1" movement).

[0432] For method II, mirror 2091 can guide rigidification device 2000 (e.g., the distal end of mirror 2091 and the distal end of rigidification device 2000 may never be approximately aligned), while the rigidification device repeatedly switches between flexible and rigid states to aid mirror advancement. For example, when advancing mirror 2091, rigidification device 2000 can be rigid, thereby helping to prevent mirror loops and facilitating the transmission of mirror forces. Once mirror 2091 has been advanced, the rigidification device can become flexible again and advance distally on the mirror. This process can be repeated.

[0433] Method III may include the following steps: (1) the rigidification device 2000 may be in a flexible state, with its distal end substantially aligned with the distal end of the mirror 2091; (2) the mirror 2091 may be steered, wherein the distal end of the rigidification device 2000 is located on top of the mirror and is thus steered by the mirror 2091; (3) the rigidification device 2000 may be placed in a rigid state reflecting the steered position of the mirror 2091; (4) the distal end of the mirror 2091 may be advanced. This point-and-shoot method can advantageously advance the mirror 2091 in the direction pointed to by its tip. In some embodiments, these steps may be repeated to advance the rigidification device 2000 and the mirror 2091 into a body cavity or cavity.

[0434] It should be understood that methods I-III can be used in combination. Furthermore, in some embodiments, the rigidification device can be steerable to further provide orientation for the mirror.

[0435] Three different control methods can be used in the digestive tract. For example, ... Figure 69A As shown, these techniques allow the endoscope 2691a to be positioned within the upper digestive tract 2646z using the rigidification device 2600a. For example... Figure 69B As shown, as another example, the rigidification device 2600b can be used to position the endoscope 2691b in the lower digestive tract 2647z. The control method described herein allows... Figure 69A and 69BThe positioning shown is easier and faster to achieve, while minimizing the risk of complications such as gastrointestinal perforation and reducing or eliminating patient discomfort with the endoscopic loop.

[0436] The rigid device and system described in this invention can be used for endoscopic retrograde cholangiopancreatography (ERCP) and / or direct cholangioscopy (DC). The purpose of ERCP is to diagnose and treat diseases of the bile ducts and pancreatic ducts. The most common method is to perform the procedure using a lateral-viewing duodenoscope, guiding a guidewire into the bile ducts and pancreatic ducts, injecting contrast agent into these ducts, observing under a fluorescence microscope, and passing various instruments through these ducts along the guidewire. Ideally, the ducts would be visualized directly using a camera instead of radiation and contrast agent injection. By inserting a small endoscope into the bile duct, the bile duct can be directly observed without radiation. However, it is difficult to guide such a small endoscope through the stomach and into the bile duct because the endoscope would form a loop.

[0437] Bile duct or pancreatic duct cannulation is difficult for two reasons. First, the endoscope must be very small to fit the small tubes, meaning it is very flexible and thus twists within the stomach when attempting to exit. Second, the tube inlet (papillary) is on one side of the duodenal wall, meaning the endoscope must bend and advance at an angle relative to its long axis, which would be impossible without a deflecting abutment surface. The rigidification device described in this invention can provide a more optimized path and stability during ERCP and DC, including in kinematically and clinically challenging papillary cannulation tasks. For example, the device described in this invention can be used both to reach the papilla (typically done with a duodenoscopy) and for cannulation of the bile duct and pancreatic tree.

[0438] refer to Figure 70A-72D The rigidification device described in this invention can be used in various ways for ERCP and direct visualization of the pancreas / bile duct (cholangioscopy). For example, as Figures 70A-70B As shown, a rigid device 8300 with a steerable distal end 8302z (which can be similar to) can be used on the cholangioscope 8391. Figure 25The cholangioscope 8391 can be a flexible endoscope with a camera, lighting equipment, and optionally a tool channel designed to have the necessary bending radius and diameter for access to the bile duct. The bending radius of the cholangioscope 8391 can be 0.5 inches, and its distal end and insertion tube diameter can be 2-6 mm. The cholangioscope 8391 can be placed inside the rigidification device 8300, and the rigidification device 8300 can begin in a flexible state. Both devices 8300 and 8391 can be navigated together through the upper gastrointestinal tract to the duodenum 8354 (or, if the operator deems it necessary, the cholangioscope 8391 can be advanced before the rigidification device 8300, which follows behind). Once inside the duodenum 8354z, the rigidification device 8300 can be rigidified and turned to tilt the cholangioscope 8391 toward the entrance of the duct (papillary tract 8355z). The rigidification device 8300 can be locked in place, and the choledochoscope 8391 can be advanced toward the mastoid process 8355. The guidewire 8385 can be pushed through the choledochoscope 8391 and aligned with the entrance to the mastoid process 8355z, and pushed through the bile duct 8357z or pancreatic duct 8356z (its positioning within the bile duct 8355z is as follows). Figure 70A As shown). Figure 70B As shown, the cholangioscope 8391 can be advanced into the bile duct 8357 via the guidewire 8385 for direct cannulation. In this method, the rigidification device 8300 advantageously supports the small cholangioscope 8391 to prevent it from twisting in the stomach, and the steering portion 8302z of the rigidification device 8300 advantageously deflects the cholangioscope 8391 toward the mastoid process. Therefore, direct visualization can be achieved, reducing the radiation dose required during ERCP.

[0439] Another exemplary ERCP method is as follows: Figures 71A-71B As shown. In this embodiment, a rigidification device 8400 without a steerable distal end can be used. A choledochoscope 8491 can be used to steer the rigidification device 8400 when it is in a flexible configuration, pointing it toward the papilla 8455z. Once correctly oriented, the rigidification device 8400 can be rigidified. The choledochoscope 8491 can then be used in accordance with the above reference. Figures 70A-70B The procedure is performed in the same manner. This method can be referred to as the "spot firing" method for direct cholangioscopy.

[0440] Another exemplary ERCP method is as follows: Figures 72A-72D As shown. In this embodiment, the rigidification device 8500 includes at least two working channels (e.g., similar to...). Figures 20A-20B(And the device shown in 21). The cholangioscope 8591 is initially placed along the first tool channel for navigation and cannulation of the papilla 8555z. Once the guidewire 8585 has been passed through the bile duct 8557z (as shown in 21), Figure 72B (as shown) or pancreatic duct (8556z), the cholangioscope 8591 can be removed from the first tool channel, while the guidewire 8585 remains in the appropriate position within the duct 8557z (e.g. Figure 72C (As shown). Then, the cholangioscope 8591 can be inserted into the second tool channel (e.g., as shown in Figure 81, which can extend laterally out of the wall of the device 8500), so that the duodenal-side papillae 8555z (as shown) can be visualized. Figure 72D (As shown). The first tool channel can be used to place larger instruments, such as stents 8558z, which will be placed in the conduit 8557z. In some embodiments, since stents 8558z occupy most of the diameter of the conduit 8557z and a portion of stents 8558z remains within the duodenum 8554z, external (duodenal) visualization of the papilla 8555z during stent placement may be useful.

[0441] In another exemplary ERCP method, similar to Figure 59 The rigidification device of the illustrated apparatus includes a single tool channel running the entire length of the apparatus. The rigidification device includes a camera attached to the outside of the rigidification device just proximal to the turning section. Intubation, ERCP, and direct cholangioscopy can be performed similarly to the methods described above. When using a stent or larger instruments, the cholangioscopy can be removed from the tool channel, and the camera of the rigidification device can be used to visualize the external mastoid process when using larger instruments or stents.

[0442] In another exemplary ERCP method, such as Figures 46A-46B As shown, the rigidification device includes a suction tip at its distal end. The suction tip can surround the mastoid process, and suction can be applied at the tip. This action stabilizes the mastoid, making it easier to aim the cholangioscope at the appropriate location to pass the guidewire. The surrounding tissues of the mastoid also provide some counter-tension when the mastoid is pushed with the wire or cholangioscope. Providing counter-tension to the compressive force of the cholangioscope or other instruments can reduce the number of sphincterotomies (mastoidotomies) required.

[0443] Advantageously, the rigidification device for ERCP described in this invention can be disposable and sterile, thereby reducing the risk of infection or cross-contamination between patients. Furthermore, the method reduces radiation and can be easily guided to the mastoid process by means of the rigidification device and / or the steering function of the endoscope.

[0444] The rigidification devices and systems described in this invention can be used in cardiology and cardiac surgery, including heart valves (e.g., aortic and mitral valves).

[0445] Typically, in transcatheter, percutaneous procedures, clinicians use a flexible rod or axis—one with sufficient rigidity to advance the catheter to the treatment site, yet flexible enough to conform to the anatomy—to influence the movement of the access site (e.g., arteries or veins in the groin, arm, etc.). This means that all forces or leverage are generated at the distal access site and react in a more localized anatomical structure to: (a) bend the flexible rod or axis to navigate to the surgical site; and (b) provide localized forces (linear forces and torques) at the surgical site. In contrast, the dynamic rigidification device described in this invention provides a method for efficiently moving the access site to the treatment site, navigating (e.g., advancing) through tortuous anatomical structures to the treatment site, initially in a flexible state, then rigidified to form a stable port at the treatment site independent of anatomical reflexes.

[0446] One advantage of the rigidification device described in this invention is its ability to conform to surrounding anatomical structures, such as the vascular system. Devices such as guide catheters need to have a certain degree of rigidity to advance through anatomical structures (such as the vascular system) and perform the desired function. However, rigid systems can hinder the device's advancement to the target anatomy, at least in part because the highly tortuous path forces the anatomy to conform to the device, which can interfere with passage and potentially cause damage to surrounding tissues and blood vessels. In contrast, the rigidification device described in this invention can be flexible enough to move within the blood vessels, conforming to the vascular system rather than reshaping it. In some embodiments, the inch-peristalsis allowed by the rigidification device or nesting system enables this flexible forward movement. Once the device has advanced to the target site, rigidification allows for the preservation and utilization of the established path through the vascular system. For example, the rigidity of the rigidification device described in this invention can be 1 / 10 of a typical guide catheter in a flexible state and 5 times that of a typical guide catheter in a rigid state.

[0447] In some embodiments, the rigidification device described in this invention can be used in percutaneous surgery of the heart or vascular system. The rigidification device conforms to cardiac anatomy and provides a local distal fulcrum for instrument manipulation. Currently, during percutaneous surgery, mechanical fixation and stabilization occur at the proximal site (e.g., femoral vein, radial artery, iliac vein, etc.). As described above, this fixation point generates a long lever arm extending from the proximal site to the surgical site. Furthermore, as described in a further detailed description below, the mechanical connection created between the proximal site and the target anatomy by a typical rigid catheter system relies on anatomical reflexes to guide the catheter tip and transfer force to the instrument used. When a rigid catheter system is bent to conform to the anatomy, it generates potential energy along the proximal path. This energy can be released when the operator intentionally or unintentionally moves the patient at the proximal site. In contrast, the rigidification device described in this invention conforms to the anatomical path prior to rigidification, thereby eliminating the stored energy associated with rigid catheter systems. Once rigidified, mechanical fixation can be achieved independently of anatomical reflexes, significantly reducing the lever arm and enhancing the surgeon's control over the surgical instruments, resulting in more predictable outcomes. In some embodiments, the rigidification device may include an integrated hemostatic valve, eliminating the need for a separate access sleeve.

[0448] In some embodiments, the rigidification device described in this invention can be used to harden the guide sheath in interventional cardiology or structural heart cases. For example, the rigidification device can be used to provide a “rail” for a transcatheter aortic valve replacement (TAVR) device, thereby preventing the tip of the TAVR catheter from scraping and rubbing against the top of the aortic arch, which is typically burdened with thrombus (current systems tend to straddle the outside of the arch, rubbing plaque and generating embolic fragments). The rigidification device facilitates excellent alignment and placement, reduced perivalvular leakage, and more optimized placement compared to pacing nodes. Providing a separate “rail” for the TAVR device can advantageously allow the artificial heart valve to rotate in situ for better alignment.

[0449] In some embodiments, the rigidification device described in this invention can be used as a delivery system that can travel from the venous circulation through the right atrium and interatrial septum, through the mitral valve into the left atrium, and then antegradely into the left ventricular outflow tract and aortic valve. This approach facilitates transcatheter aortic valve implantation (TAVI) and avoids contact with the aortic arch and the typically retrograde ascending aorta. In some embodiments, the rigidification device described herein can be used to deliver mitral valve replacements. That is, traversing the septal wall during mitral valve replacement can be particularly difficult due to the involvement of multiple blood vessels, a beating heart, and the need for precise alignment and stabilization before implant delivery. Current valve delivery platforms can be quite rigid, which is dangerous for their straightened anatomical structures (such as the femoral artery, which can be highly calcified and fragile). The rigidification device described herein can advantageously produce a flexible-access catheter, which is then rigidified to the shape of any particular human anatomy, conforming to the entire anatomical pathway. Therefore, the rigidification device described herein allows clinicians to create a stable mechanical lumen directly accessible to the anatomical structure, positioning it without significant local anatomical load, and then rigidly stabilizing it in that shape as the device is delivered through it...

Claims

1. A rigidification device, comprising: The slender, flexible body is configured to switch between a flexible and a rigid configuration by applying pressure. The elongated flexible body contains a filament layer comprising a plurality of filaments configured to slide within the wall of the elongated flexible body in the flexible configuration. A box located at the proximal end of the elongated flexible body, wherein the box is configured to be mounted into a robotic system; as well as A pressure source located within the box is configured to apply pressure within the wall of the elongated flexible body to restrict the movement of the plurality of filaments by compressing the filament layer, thereby converting the elongated flexible body into the rigid configuration.

2. The apparatus of claim 1, wherein, The pressure source is a pre-filled pressure source.

3. The apparatus of claim 1, wherein, The pressure source includes a syringe.

4. The apparatus of claim 1, wherein, The pressure source includes a bellows.

5. The apparatus of claim 1, wherein, The filament layer is a textile layer.

6. The apparatus of claim 1, wherein, The filament layer is a braided layer.

7. The apparatus of claim 1, wherein, The filament layer comprises a plurality of longitudinally arranged filaments.

8. The device of claim 1, further comprising a capsule layer configured to be driven against the filament layer when pressure is applied.

9. The apparatus of claim 1, wherein, The box is configured to be mounted onto a robotic arm.

10. The apparatus of claim 1, wherein, The box includes one or more mechanical connectors configured to be coupled to a drive unit on the robot system.

11. The apparatus of claim 10, wherein, The one or more mechanical connectors are coupled to one or more cables to bend or deflect the distal region of the elongated flexible body.

12. The apparatus of claim 1, wherein, The pressure source is configured to apply positive pressure.

13. The apparatus of claim 1, wherein, The pressure source is configured to apply negative pressure.

14. A rigidification device, comprising: The slender, flexible body is configured to switch between a flexible and a rigid configuration by applying pressure. The elongated flexible body contains a filament layer comprising a plurality of filaments configured to slide within the wall of the elongated flexible body in the flexible configuration. A capsule layer, which is configured to be driven against the filament layer when pressure is applied; A box located near the proximal end of the elongated flexible body, wherein the box is configured to be mounted into a robotic system; as well as A pre-filled pressure source located within the box is configured to apply positive pressure within the wall of the elongated flexible body, thereby restricting the movement of the plurality of filaments by compressing the filament layer, thus converting the elongated flexible body into the rigid configuration.

15. The apparatus of claim 14, wherein, The pre-filled pressure source includes a syringe.

16. The apparatus of claim 14, wherein, The filament layer includes a textile layer or a braided layer.

17. The apparatus of claim 14, wherein, The filament layer comprises a plurality of longitudinally arranged filaments.

18. The apparatus of claim 14, wherein, The box is configured to be mounted onto a robotic arm.

19. The apparatus of claim 14, wherein, The box includes one or more mechanical connectors configured to connect to a drive unit on the robot system, wherein the one or more mechanical connectors are coupled to one or more cables to bend or deflect the distal region of the elongated flexible body.

20. A rigidification device, comprising: The slender, flexible body is configured to switch between a flexible and a rigid configuration by applying pressure. The elongated flexible body contains a filament layer comprising a plurality of filaments configured to slide within the wall of the elongated flexible body in the flexible configuration. A capsule layer, which is configured to be driven against the filament layer when pressure is applied; A box located at the proximal end of the elongated flexible body, wherein the box is configured to be mounted into a robotic system; as well as A pre-filled pressure source includes a syringe located within the cartridge, the syringe being configured to apply pressure within the wall of the elongated flexible body to restrict the movement of the plurality of filaments by compressing the filament layer, thereby converting the elongated flexible body into the rigid configuration.

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