Tendon rigidization device

Abstract

This document describes a rigidification device (e.g., an apparatus, system, etc.) and its method of use, which can rigidify a highly flexible and maneuverable configuration to a highly rigid configuration over a longer section of the apparatus while maintaining a relatively small diameter. In particular, this document describes an apparatus and method including a pressure-compression tendon that can be used in conjunction with a second rigidification layer to enhance stiffness, particularly in the distal end region.

Description

[0001] Priority requirements This patent application claims priority to U.S. Provisional Patent Application No. 63 / 610,968, entitled “TENDON-RIGIDIZING APPARATUSES”, filed December 15, 2023, which is incorporated herein by reference in its entirety.

[0002] background Surgical devices can include elongated, sometimes tubular structures that include catheters, sheaths, scopes (e.g., endoscopes), sutures, outer cannulas, cannulas, trocars, or laparoscopic instruments. The device can be used as a standalone add-on or integrated into the main body of a device. These devices can be combined with other devices to form more complex systems, including nested systems. The device is inserted into the body to access areas within the body, including in some cases forming a passage for additional diagnostic and therapeutic medical devices. In some cases, it may be advantageous for such elongated medical devices to be rigid or flexible, and in many cases, changing these devices from a flexible configuration to a rigid configuration would be particularly beneficial. Highly flexible devices have significant advantages, as do rigid devices, but each type also has disadvantages. Flexible endoscopes and catheters rely on the reaction force generated by pushing against tissue within the explored body cavity to navigate through corners or bends in anatomical structures. Flexibility can be problematic when traversing body parts with highly tortuous passages, relatively open areas, or passages with varying (or large) luminal diameters (where reliable contact with the outer diameter of the tube is difficult to establish). Furthermore, highly flexible tubes may deform, sag, coil, or have problems supporting additional tools or equipment. Highly rigid tubes may be difficult to navigate within the body, and if forced through certain anatomical pathways, they may cause damage to anatomical structures.

[0003] Therefore, it may be advantageous to provide devices that can switch between rigid and flexible configurations as needed. In particular, it would be beneficial to provide rigid devices where the rigid configuration is sufficiently rigid that it resists shape change even when considerable forces are applied. Ideally, such devices in flexible configurations would be highly flexible, allowing them to assume bending and / or bending configurations (including configurations with small radii of curvature) without requiring significant amounts of force. Such devices could provide safe, efficient, and precise access to otherwise inaccessible anatomical locations, and once reached, enable more effective treatment.

[0004] This article describes apparatus and methods that can meet these requirements.

[0005] Overview of this disclosure This document describes a rigidification device (e.g., an apparatus, system, etc.) and its method of use, which can rigidify a highly flexible and maneuverable configuration to a highly rigid configuration over a long section of the apparatus. In particular, this document describes an apparatus and method that includes a pressure-compression tendon.

[0006] A rigidification device comprising multiple pressure-compression tendons may include: an elongated flexible tube extending along a proximal to distal length direction; multiple pressure-compression tendon segments extending along the elongated flexible tube in a predominant longitudinal orientation; and a compression layer configured to compress the multiple pressure-compression tendon segments against the elongated flexible tube when pressure is applied, wherein the rigidification device is configured to change between a rigid state and a flexible state by applying or releasing pressure. Any of these devices may include an inlet configured to apply pressure to press the compression layer against the multiple pressure-compression tendon segments. The flexible tube may be an internal support tube.

[0007] In any of these rigidification devices, at least some of the pressure-compression tendon segments may extend proximally to the proximal end of the rigidification device and may be configured to steer the distal end of the elongated flexible internal support tube. At least some of the pressure-compression tendon segments may be unattached at their proximal ends or form a loop connecting two of the pressure-compression tendon segments. The plurality of pressure-compression tendon segments may include a steerable subset of tendons extending proximally to the proximal end of the rigidification device and configured to steer the distal end of the elongated flexible internal support tube; further, the plurality of pressure-compression tendon segments may include a non-steerable subset of tendons unattached at their proximal ends or form a loop connecting two of the plurality of pressure-compression tendon segments.

[0008] Any of these devices may include a set of steering tendons extending along a length direction from proximal to distal. The steering (or steering / actuating) tendons may be a subset of the pressure-compression tendons, or the steering (or steering / actuating) tendons may be separate from the pressure-compression tendons.

[0009] The pressure-compression tendon segments may be radially spaced from each other along the proximal to distal length of the elongated flexible internal support tube. The elongated flexible internal support tube may be an internally coiled tube. In some examples, the elongated flexible internal support tube is a laser-cut thiocyanate tube.

[0010] The compression layer can be configured to be radially outward, radially inward, or both. For example, the compression layer may include a bladder configured to receive positive pressure against an elongated flexible internal support tube to extend and compress multiple pressure-compression tendon segments. The compression layer can also be configured to receive negative pressure against an elongated flexible tube to compress multiple pressure-compression tendon segments. The pressure-compression tendon segments may be located along their length within multiple guides / tubes, which periodically (e.g., every...) x mm, where x An opening is provided to expose the tendon in the area between approximately 0.5 mm and 5 mm or greater, between approximately 0.5 mm and 4.5 mm or greater, or between approximately 0.5 mm and 5 mm or greater.

[0011] The pressure-compression tendon segment may be blunted at its proximal end (e.g., provided with an end cap). In some examples, the pressure-compression tendon may be at least partially contained (e.g., in some cases, the end of the pressure-compression tendon may be contained) within a tube or channel, which allows the pressure-compression tendon to slide within the channel while remaining within the channel when the device is bent. The pressure-compression tendon segment may be secured to an elongated flexible tube by a sheath. As used herein, a sheath may generally refer to a structure that secures the tendon in a particular radial orientation while allowing the tendon to slide axially in a flexible configuration; in some cases, the sheath may be compressed to prevent the tendon from sliding in a rigid configuration. The sheath may comprise a material with any suitable hardness; for example, in some cases, the sheath may have a hardness of 60A or less on a Shore A hardness tester. In some examples, the sheath comprises a braid. Multiple pressure-compression tendon segments may comprise 4 to 24 pressure-compression tendon segments. Thus, the pressure-compression tendon may not be attached at the proximal end and / or the distal end and / or may be continuous (e.g., forming repeating loops, typically non-overlapping patterns). A pressure-compression tendon can be contained within one or more channels. In some examples, the pressure-compression tendon can be held within one or more tubes; portions of the pressure-compression tendon may be located outside the tube.

[0012] Any of these devices may include an elongated flexible external support tube that extends along a proximal to distal length over an elongated flexible internal support tube, multiple pressure-compression tendon segments, and a compression layer.

[0013] For example, a rigidification device may include: an elongated body including a support layer; a proximal region of the elongated body having a rigidification layer comprising a plurality of intersecting strand segments; a distal region of the elongated body including a plurality of pressure-compression tendons extending proximally along the long axis of the elongated body; and a compression layer configured to receive positive and / or negative pressure to rigidify the elongated body by abutting against the support layer and by preventing or limiting axial movement of the plurality of pressure-compression tendons, wherein the rigidification device is configured to switch between a flexible configuration and a rigid configuration.

[0014] Multiple strands may intersect each other (upper or lower) at braiding angles greater than approximately 5 degrees (e.g., greater than approximately 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, etc.) relative to the longitudinal axis of the flexible tube (e.g., the angle between strands relative to the long axis of the device). In contrast, multiple pressure-compression tendon segments may extend proximally along the axis of the elongated body segment (e.g., within + / - 5 degrees, + / - 4 degrees, + / - 3 degrees, + / - 2 degrees, or + / - 1 degree relative to the long axis).

[0015] A compression layer (e.g., a bladder) can extend along both the proximal and distal regions and can actuate the rigidity of both the proximal and distal regions by restricting the movement of both the pressure-compression tendon and the multiple strand segments. A compression layer may include a bladder; in some cases, the compression layer is an out-and-back bladder inverted on itself.

[0016] At least some of the pressure-compression tendon segments may extend proximally to the proximal end of the rigidification device and may be configured to steer the distal end of the elongated flexible internal support tube (e.g., may be part of a manipulation subset of the tendon). In some cases, multiple pressure-compression tendon segments include a subset of tendons, which includes a steering tendon that extends proximally to the proximal end of the rigidification device and is configured to steer the distal region of the elongated flexible internal support tube.

[0017] According to claim 1, the pressure-compression tendon segment is unattached at its proximal end. In some cases, even if it is not a steering tendon, the pressure-compression tendon may extend into the proximal region. For example, the pressure-compression tendon may extend at least partially or, in some cases, completely through the proximal region. In some cases, the pressure-compression tendon is confined to the distal region or extends partially into the proximal region (e.g., overlapping with both the pressure-compression tendon and the multiple strand segments of the rigidification layer). It should be noted that the multiple strand segments forming the rigidification layer may be referred to herein as a second rigidification layer. In some cases, the multiple strand segments may overlap with the pressure-compression tendon over the entire rigidification length of the rigidification device. In some cases, the strand segments of the multiple rigidification layers may be excluded from the distal end region.

[0018] At least some of the compression tendon segments may be connected to each other at their proximal ends. The compression tendon segments may be radially spaced apart from each other along the proximal to distal length of an elongated flexible internal support tube. The device may include spacers (e.g., channels) for maintaining the spacers. In some cases, the compression tendons may be within a sleeve that helps hold the compression tendons in a desired radial position.

[0019] The support layer may include an inner coil-wound tube (ICWT, for example, a polymer material reinforced by one or more coils, such as, but not limited to, a helically wound coil, which may be, for example, a metallic material), and / or the support layer may include an outer coil-wound tube (OCWT, for example, a polymer material reinforced by one or more coils, such as, but not limited to, a helically wound coil, which may be, for example, a metallic material). The device may include both an inner support layer (e.g., ICWT) and an outer support layer (e.g., OCWT).

[0020] The compression layer can be configured to receive positive pressure to rigidify the elongated body and / or receive negative pressure to rigidify the elongated body. In some cases, positive pressure can be applied to push the compression layer (e.g., a sac) to compress the multiple strands and tendons, thereby limiting the ability of the multiple strands and tendons to move relative to each other and / or other layers of the elongated body; for example, positive pressure can be applied to the compression layer on the side opposite to the multiple strands and tendons. In some cases, negative pressure can be applied to pull the compression layer (e.g., a sac) to compress the multiple strands and tendons; for example, negative pressure can be applied to the compression layer on the same side as the multiple strands and tendons. In some cases, both negative and positive pressure can be applied, for example, applying negative pressure to the same side of the compression layer as the multiple strands and tendons and applying positive pressure to the side of the compression layer separated from the multiple strands and tendons.

[0021] The pressure-compression tendon segments can each be held within a guide channel and / or tube extending along the long axis of the elongated body. In any of these devices, the pressure-compression tendon segments are unattached at their proximal and distal ends.

[0022] Any number of pressure-compression tendon segments can be used. For example, multiple pressure-compression tendon segments can include 4 to 25 segments. Multiple pressure-compression tendon segments can be formed from a single ring of material or a single long tendon that is bent or flexed.

[0023] In some cases, the rigidification device may include: an elongated body extending along a long axis from proximal to distal; a plurality of pressure-compression tendon segments extending along the long axis in a distal region of the elongated body, the plurality of pressure-compression tendon segments being configured to slide axially relative to the elongated body in a flexible configuration; a rigidification layer extending in a proximal region of the elongated body, the rigidification layer comprising a plurality of strand segments being configured to slide against each other in a flexible configuration; and a compression layer configured to rigidify the first rigidification device by preventing axial sliding of the pressure-compression tendons and sliding of the plurality of strand segments against each other when pressure is applied to the compression layer.

[0024] Any of the devices described herein may be configured to form a nested system of rigidification devices, the device further comprising a second rigidification device configured to rigidify, wherein the second rigidification device is nested with the first rigidification device, and wherein the rigidification devices are configured to translate relative to each other and rigidify to transmit shape along the nested system.

[0025] A rigidification layer may extend on an elongated flexible tube in the proximal region. This rigidification layer comprises a plurality of filaments that intersect each other vertically and are configured to shear relative to each other in a flexible state. At least some of the pressure-compression tendon segments may extend proximally to the proximal end of the rigidification device and are configured to steer the distal end of the elongated flexible tube. In some cases, at least some of the pressure-compression tendon segments are unattached at their proximal ends or form a loop connecting two of the pressure-compression tendon segments. The plurality of pressure-compression tendon segments include a steerable subset of tendons that extends proximally to the proximal end of the rigidification device and is configured to steer the distal end of the elongated flexible tube. Further, the plurality of pressure-compression tendon segments include a non-steerable subset of tendons that are unattached at their proximal ends or form a loop connecting two of the plurality of pressure-compression tendon segments.

[0026] The pressure-compression tendon segments can be held in radially spaced positions along the length of the elongated flexible internal support tube from the proximal to the distal side.

[0027] As described above, any of these devices may include an inner coil-wound tube (inner support layer) and / or an outer coil-wound tube (e.g., an outer support layer). The compression layer may include a bladder configured to apply positive pressure. The compression layer may be configured to apply negative pressure to compress multiple pressure-compression tendon segments against an elongated flexible tube.

[0028] The pressure-compression tendon segment may be located along its length within a plurality of guides / tubes, which are periodically provided with openings to expose the tendon. The pressure-compression tendon segment may be blunted at its proximal end or otherwise provided with an end cap. The pressure-compression tendon segment may be secured to an elongated flexible tube using a material with a Shore A hardness of 60A or less. A plurality of pressure-compression tendon segments may include 4 to 24 segments.

[0029] This document also describes a method for rigidifying a device using longitudinal pressure-compression tendons. For example, one method may include: turning a distal end region of the rigidified device, while in a flexible configuration, such that the distal end region bends, wherein the rigidified device includes an elongated flexible internal support tube extending in a proximal-to-distal length direction; applying pressure to compress a plurality of pressure-compression tendon segments extending longitudinally along the elongated flexible internal support tube to rigidify the rigidified device, wherein the applied pressure is maintained to hold the rigidified device in a rigid configuration; and releasing the pressure to convert the rigidified device back to a flexible configuration.

[0030] For example, a method may include: while in a flexible configuration, turning a rigid device to bend it, wherein the rigid device includes an elongated body, a plurality of pressure-compression tendons, and a rigidification layer, the elongated body extending proximally to distally along a long axis, the plurality of pressure-compression tendons extending longitudinally parallel to the long axis in a distal region of the elongated body, and the rigidification layer extending in a proximal region of the elongated body, wherein the rigidification layer includes a plurality of intersecting strands; and applying pressure such that the compression layer within the elongated body prevents or restricts axial movement of the pressure-compression tendons and prevents the plurality of strands from sliding against each other, to convert the rigid device into a rigid configuration; and releasing the pressure to convert the rigid device into a flexible configuration. The method may include using one or more pressure-compression tendons to turn the distal end region. In some cases, turning includes replicating the shape of the elongated device within the lumen of the rigid device. Any of these methods may include inserting the device into a lumen of a patient's body. Applying pressure may include applying positive and / or negative pressure.

[0031] Orienting the distal end region may include using one or more pressure-compression tendon segments to orient the distal end region. In some examples, orienting the distal end region may also include using a nested system of rigidification devices that can use shape replication to orient at least one of the rigidification devices.

[0032] Elongated devices within the cavity of rigid devices may include rigid catheters, sheaths, observation instruments (e.g., endoscopes), wires, outer cannulas, cannulas, trocars, laparoscopic instruments, etc.

[0033] Any of these methods may include inserting the device into an internal cavity of the patient's body.

[0034] Applying pressure can include applying positive pressure to drive the compression layer of the rigidification device against multiple pressure-compression tendons of various lengths, thereby locking the rigidification device in a rigid configuration. For example, applying pressure can include applying negative pressure to drive the compression layer of the rigidification device against multiple pressure-compression tendon segments, thereby locking the rigidification device in a rigid configuration.

[0035] This document also describes a hybrid device having a first region and a second region, the first region being rigidified using a pressure-compression tendon, and the second region having a mesh-like rigidification layer / distal end with a pressure-compression tendon. Any number of regions may be included, including two or more, three or more, etc. For example, some longitudinal regions may be rigidified solely by pressure-compression tendons. Some longitudinal regions may be rigidified by both pressure-compression tendons and rigidification layers (e.g., multiple intersecting filaments, etc.). Some longitudinal regions may be rigidified solely by rigidification layers, etc. Typically, regions rigidified by pressure-compression tendons may include an arrangement in which the pressure-compression tendons do not intersect each other. The pressure-compression tendons may extend parallel or substantially parallel to the long axis of the device. In some examples, the pressure-compression tendons are at an angle of less than about 15 degrees relative to the long axis of the device (e.g., less than about 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, etc.).

[0036] In some examples, the rigidification device may include: an elongated body having an elongated flexible internal support tube extending in a length direction from proximal to distal; a proximal region including a rigidification layer extending on the elongated flexible internal support tube within the proximal region, the rigidification layer comprising a plurality of filaments intersecting each other vertically and configured to shear relative to each other; and a distal region including a plurality of longitudinally extending pressure-compression tendons. As described herein, the longitudinal direction may include parallel or substantially parallel to the elongated flexible tube, for example, at an angle of 15 degrees or less, 14 degrees or less, 13 degrees or less, 12 degrees or less, 11 degrees or less, 10 degrees or less, 9 degrees or less, 8 degrees or less, 7 degrees or less, 6 degrees or less, 5 degrees or less, 4 degrees or less, 3 degrees or less, 2 degrees or less, etc.; a compression assembly (e.g., a compression layer) configured to compress the plurality of pressure-compression tendons in the distal region against the elongated flexible inner support tube and to compress the plurality of filaments of the rigidification layer against the elongated flexible inner support tube when pressure is applied, wherein the rigidification device is configured to change between a rigid state and a flexible state by applying or releasing the pressure; and an inlet at the proximal end of the rigidification device, the inlet being configured to apply pressure to compress the compression layer against the plurality of pressure-compression tendons. The compression assembly may include a compression layer extending along both the proximal and distal regions. The compression assembly may include a first compression layer extending along the proximal region and a second compression layer extending along the distal region. The compression assembly may include an inflatable bladder. At least some of the pressure-compression tendons may extend proximally to the proximal end of the rigidification device and are configured to steer the distal end of the elongated flexible internal support tube.

[0037] At least some of the pressure-compression tendon segments may be unattached at their proximal ends, or form a loop connecting two of the pressure-compression tendon segments. The plurality of pressure-compression tendon segments may include a deflecting subset of tendons that extends proximally to the proximal end of the rigidification device and is configured to deflect the distal end of the elongated flexible internal support tube, and further wherein the plurality of pressure-compression tendon segments include a non-deflecting subset of tendons that is unattached at its proximal end or forms a loop connecting two of the plurality of pressure-compression tendon segments.

[0038] Any of these devices may include a set of steering tendons extending along a length direction from proximal to distal. The steering (or steering / actuating) tendons may be a subset of the pressure-compression tendons, or the steering (or steering / actuating) tendons may be separate from the pressure-compression tendons.

[0039] The pressure-compression tendon segments may be radially spaced from each other along the proximal to distal length of the elongated flexible internal support tube. The elongated flexible internal support tube may be an internally coiled tube. In some examples, the elongated flexible internal support tube is a laser-cut thiocyanate tube.

[0040] The compression layer may include a bladder configured to apply positive pressure against an elongated flexible internal support tube to compress multiple pressure-compression tendon segments. The compression layer may also be configured to apply negative pressure against the elongated flexible internal support tube to compress the multiple pressure-compression tendon segments. The pressure-compression tendon segments may be located along their length within multiple guides / tubes, which are periodically (e.g., every...) x mm, where x An opening is provided to expose the tendon in the area between approximately 0.5 mm and 5 mm or greater, between approximately 0.5 mm and 4.5 mm or greater, or between approximately 0.5 mm and 5 mm or greater.

[0041] The compression-tendon segment may be blunted at its proximal end (e.g., with an end cap). The compression-tendon segment can be secured to an elongated, flexible internal support tube by one or more sheaths. In some cases, the sheath includes an internal channel within which the compression-tendon can slide. The sheath can be compressed against the compression-tendon; therefore, the sheath may include a soft material, such as a material with a Shore A hardness of 60A or less. In some cases, even in examples where the compression-tendon is within the sheath, the sheath may have an opening along its length (or may include multiple smaller sheaths forming an opening through which the compression-tendon can directly contact the compression layer). This can make the device more flexible and can increase its rigidity. In some examples, the sheath includes a braid. Multiple compression-tendon segments may include 4 to 24 segments.

[0042] Any of these devices may include an elongated flexible external support tube that extends along a proximal to distal length over an elongated flexible internal support tube, multiple pressure-compression tendon segments, and a compression layer.

[0043] This document also describes methods for using these devices (including hybrid devices). For example, one method may include: turning the rigid device, causing it to bend, while the rigid device is in a flexible configuration, wherein the rigid device includes an elongated flexible inner support tube extending in a proximal to distal length direction, a plurality of pressure-compression tendons extending longitudinally along the elongated flexible inner support tube in a distal region of the rigid device, and a rigid layer extending in a proximal region of the rigid device, wherein the rigid layer includes a plurality of filaments that intersect each other vertically and are configured to shear relative to each other; applying pressure to compress the rigid layer in the proximal region and the plurality of pressure-compression tendons in the distal region against the elongated flexible inner support to convert the rigid device into a rigid configuration; and releasing the pressure to convert the rigid device into a flexible configuration.

[0044] Orienting the distal end region may include using one or more pressure-compression tendon segments to orient the distal end region. In some examples, orienting the distal end region includes replicating the shape of an elongated device that replicates the cavity of a rigid device.

[0045] An elongated device within the lumen of a rigid device may include a rigid endoscopic device. Any of these methods may include inserting the device into a lumen within the patient's body.

[0046] Applying pressure can include applying positive pressure to drive the compression layer of the rigidification device against the rigidification layer and against multiple pressure-compression tendons of various lengths, thereby locking the rigidification device in a rigid configuration. In any of these devices, the pressure-compression tendons of the rigidification may be present with an angle of zero (e.g., parallel) or near zero between the pressure-compression tendons and the long axis of the device (e.g., the long axis of an elongated tube). This differs from the angle between multiple intersecting strands in the rigidification layer that can be used with any of these devices including pressure-compression tendons. While small angles in the rigidification layer and overlapping strands can provide high rigidity, the pressure-compression tendons described herein can also be configured to provide high rigidity. The techniques described herein can contribute to this high rigidity, including applying positive pressure and arranging elements. In some cases, using pressure-compression tendons at the distal end and using the rigidification layer in a more proximal region can provide a balance between rigidity and flexibility, particularly at the distal end of the device. These devices and methods can be particularly useful in nested systems, for example, using a pair of concentrically arranged rigidification devices.

[0047] As described above, applying pressure may include applying negative pressure to drive the compression layer of the rigidification device against the rigidification layer and against multiple pressure-compression tendons of various lengths, thereby locking the rigidification device in a rigid configuration.

[0048] This document also describes a nested system comprising one or more devices, the devices including one or more regions that can be rigidified by pressure-compression tendons. For example, a system of nested rigidification devices may include: a first rigidification device comprising an elongated flexible inner support tube extending in a proximal-to-distal longitudinal direction; a plurality of pressure-compression tendon segments extending longitudinally along the elongated flexible inner support tube; and a compression layer configured to compress the plurality of pressure-compression tendon segments against the elongated flexible inner support tube when pressure is applied, wherein the rigidification device is configured to change between a rigid state and a flexible state by applying or releasing pressure; and a second rigidification device configured to be rigidified, nested with the first rigidification device; wherein the first and second rigidification devices are configured to translate relative to each other and be rigidified to conduct shape along the nested system. The first and second rigidification devices may be nested relative to each other. In some cases, the second rigidification device may be nested within the first rigidification device. In some cases, the first rigidification device is nested within the second rigidification device.

[0049] Multiple pressure-compression tendons of the first rigidification device may extend over a distal region of an elongated flexible internal support tube and may also include a proximal region comprising a rigidification layer extending over the elongated flexible internal support tube within the proximal region. The rigidification layer comprises multiple filaments that intersect each other vertically and are configured to shear relative to each other in a flexible state. Furthermore, the compression layer is configured to abut against the elongated flexible internal support tube and compress the rigidification layer when pressure is applied to rigidify the proximal region.

[0050] At least some of the pressure-compression tendon segments may extend proximally to the proximal end of the rigidification device and are configured to steer the distal end of the elongated flexible internal support tube. At least some of the pressure-compression tendon segments may be unattached at their proximal ends, or may form a loop connecting two of the pressure-compression tendon segments.

[0051] In any of the devices described herein, the device may include a steering tendon. The steering tendon may be part of a compression tendon or may be separate from a compression tendon. In any of these devices, the steering cable may be configured to steer only the distal end region of the device (e.g., bend). For example, the device may include a link within an elongated body that can be bent by actuating (e.g., pushing / pulling) the steering tendon.

[0052] For example, the plurality of pressure-compression tendon segments may include a turning subset of tendons that extends proximally to the proximal end of the rigidification device and is configured to turn the distal end of the elongated flexible internal support tube, and further wherein the plurality of pressure-compression tendon segments include a non-turning subset of tendons that is not attached at its proximal end or forms a loop connecting two of the plurality of pressure-compression tendon segments.

[0053] Any of these systems may include a set of steering tendons extending along a proximal to distal length direction. The pressure-compression tendon segments may be radially spaced apart from each other along the proximal to distal length direction of an elongated flexible internal support tube. The elongated flexible internal support tube may be an internally coiled tube, a laser-cut hypotube, etc. The compression layer may include a bladder configured to apply positive pressure against the elongated flexible internal support tube to compress the multiple pressure-compression tendon segments. In some examples, the compression layer is configured to apply negative pressure against the elongated flexible internal support tube to compress the multiple pressure-compression tendon segments. The pressure-compression tendon segments may be located along their length within a plurality of guides / tubes, which are periodically provided with openings to expose the tendons.

[0054] Any combination of all methods and apparatuses described herein is contemplated herein and can be used to achieve the benefits described herein. Brief description of the attached diagram A better understanding of the features and advantages of the methods and apparatus described herein will be obtained by referring to the following detailed description of illustrative embodiments and the accompanying drawings: Figure 1A and Figure 1B An example of a portion of an elongated rigidizable device that can be rigidified by applying negative pressure is shown. The elongated rigidizable device includes a pressure-compression tendon extending longitudinally along an elongated flexible internal support tube. Figure 1A The device is shown in a flexible configuration. Figure 1B The device is shown in a rigid configuration.

[0056] Figure 2A and Figure 2B An example of a portion of an elongated rigidizable device that can be rigidified by applying positive pressure is shown. The elongated rigidizable device includes a pressure-compression tendon extending longitudinally along an elongated flexible internal support tube. Figure 2A The device is shown in a flexible configuration. Figure 2B The device is shown in a rigid configuration.

[0057] Figures 3A-3C An example cross-section of an elongated rigidizable device is shown, which includes a pressure-compression tendon and a deflector extending longitudinally along the device. Figure 3B and Figure 3C Showing from Figure 3A Enlarged views of sections 3B and 3C.

[0058] Figures 4A-4C An example of a rigid device is shown, comprising a pressure-compression tendon extending longitudinally along the distal end region of the device. Figure 4A A top view of the fully assembled device in a flexible configuration is shown. Figure 4B An example top view of a device with a portion of the outer covering, including the compression layer, removed is shown. Figure 4C An example of a device in a rigid configuration that maintains a set shape is shown.

[0059] Figure 4D An example of a pair of nested rigidification devices is shown, the pair of nested rigidification devices including at least one rigidification device including a pressure-compression tendon as described herein.

[0060] Figure 5 An example of a method using a rigidification device including a pressure-compression tendon as described herein is illustrated schematically.

[0061] Figures 6A-6F An example of a rigidification device is shown, comprising a distal region and a proximal region. The distal region includes a pressure-compression tendon extending longitudinally along the distal end region, and the proximal region includes a rigidification layer formed by multiple filament segments intersecting each other vertically. Figure 6A In this device, a plurality of longitudinally extending pressure-compression tendons are configured to steer and rigidify the distal region. Figure 6B The device shown includes multiple pressure-compression tendons extending longitudinally downward along the proximal region, which are configured to aid in rigidity but are not connected in the proximal region to actively steer the distal region. Figure 6C An example of a rigidification device is shown, which includes a first subset of longitudinally extending pressure-compression tendons configured for steering and a second subset of longitudinally extending pressure-compression tendons configured for rigidification but not steering. Figure 6D A device comprising multiple pressure-compression tendons extending longitudinally downward along a proximal region is shown. These tendons are configured to aid in rigidity but are not connected in the proximal region to actively steer the distal region. Figure 6E In this structure, all or part of the pressure-compression tendon extends from the distal end region and overlaps with the rigidification layer (formed by multiple filament segments) in the proximal region. Figure 6F In the middle, the pressure-compression tendon extends from the distal end region and completely overlaps with the rigidification layer, as shown in the figure.

[0062] Figures 7A-7BAn example of a cross-section through a first region is shown, which includes a rigidification layer formed by multiple filaments intersecting each other vertically. This rigidification layer can be formed into, for example, Figures 6A-6C Part of any of the apparatuses shown. Figure 7A The radial cross-section is shown, while Figure 7B It shows crossing Figure 7A The cross section of the radial cross section shown.

[0063] Figures 8A-8B An example of a cross-section through a first region is shown, which includes a rigidification layer formed by multiple filaments intersecting each other vertically. This rigidification layer can be formed into, for example, Figures 6A-6C Part of any of the apparatuses shown. Figure 8A The radial cross-section is shown, while Figure 8B A partial longitudinal section is shown.

[0064] Figure 9 An example of a method using a rigidification device is illustrated, which includes a pressure-compression tendon and a rigidification layer formed by multiple intersecting wire segments.

[0065] Figures 10A-10H An example of a method for operating a pair of nested rigid elongated devices is shown, which can be selectively rigidified and derigidified to transmit shape through a tortuous path.

[0066] Figure 11 An example of a robotic system including a rigidification device comprising a longitudinally extending pressure-compression tendon is shown.

[0067] Figures 12A-12G An example of a pressure-compression tendon that can be used with any of the described devices is shown. Figure 12A In this context, pressure-compression tendons are linear segments arranged in parallel (or approximately parallel) order. Figure 12B An example of a pressure-compression tendon segment formed by a single tendon with a transverse serrated shape (with offset) is shown. Figure 12C This is another example of multiple pressure-compression tendon segments formed by a single tendon shaped as a square wave pattern, as shown in the figure. Figure 12D An example of multiple pressure-compression tendon segments enclosed in a discrete tube is shown (these segments may be part of the same tendon folded in half, or they may be separate tendons). Figure 12E In this context, pressure-compression tendons are formed from individual tendons with a sinusoidal pattern (e.g., with rounded or curved ends). Figure 12F In this context, the pressure-compression tendon is formed by discrete U-shaped tendon segments. Figure 12G In this context, the pressure-compression tendon is a discrete segment of a U-shaped tendon segment that is folded in half.

[0068] Figure 12H An example of a rigidification device comprising multiple pressure-compression tendons at the distal end is shown.

[0069] Figure 12I It shows the steering into a curved configuration. Figure 12H The equipment.

[0070] Figures 13A-13B An example of a pressure-compression tendon arranged at the distal end region of a rigidification device is shown. Figure 13A A single pressure-compression tendon segment is shown. Figure 13B It shows multiple similar Figure 13A The rigidification device for pressure-compression tendons shown has multiple pressure-compression tendons arranged in a non-overlapping region along the distal end region.

[0071] Figures 14A-14B An example of a pressure-compression tendon arranged at the distal end region of a rigidification device is shown. Figure 14A This illustrates how a pressure-compression tendon forms a pair of continuous, loop-shaped tendon segments. Figure 14B It shows multiple similar Figure 13A The rigidification device for the pressure-compression tendons shown has multiple pressure-compression tendons arranged in an overlapping region along the distal end region.

[0072] Figures 15A-15E An example of a cross-section of a portion of a rigidification device including a pressure-compression tendon is shown, as described herein. Figure 15A A pressure-actuated rigidification device is shown, comprising a pressure-compression tendon adjacent to a rigidification layer, wherein the rigidification layer and the tendon are compressed against an outer layer (e.g., an outer reinforcing tube). Figure 15B It shows something similar to Figure 15A The pressure-rigidification device shown is compressed, but the rigidification layer and tendon abut against the inner layer (e.g., an internally reinforced tube, such as one with coil winding). Figure 15C An example of the device is shown, in which the pressure-compression tendon is compressed against the outer layer and does not include an additional rigidification layer. Figure 15D This is an example of a device in which a pressure-compression tendon passes through a rigidification layer. Figure 15E An example is shown where a pair of pressure-compression tendons are pressed against the inner and outer tubes, both of which are compressed.

[0073] Figure 16- Figure 16F An example of a method for assembling a set of pressure-compression tendons for use in rigid devices as described herein is shown.

[0074] Figures 17A-17BAn example of a set of pressure-compression tendons formed by a single wire (or cable) is shown, which is configured to be connected at either end and incorporated into a longitudinally arranged configuration in the distal end region of a rigidification device. Figure 17B It shows Figure 17A A magnified view of the example shown.

[0075] Figures 18A-18B An example is shown of the distal end region of a rigidification device having a set of freely floating distal pressure-compression tendons, which are integrated with multiple rigidification layer segments (e.g., knitted fabric, braided fabric, woven fabric, mesh, etc.). Figures 18A-18B In the middle, some of the ends of the pressure-compression tendon are obscured by other layers.

[0076] Figures 19A-19B An example of a device is shown comprising multiple recesses formed within a support layer (e.g., an outer coil-wound tube layer) of a rigidification device to retain and allow compression of a pressure-compression tendon. The recesses serve both to allow movement and to confine that movement within a defined area (i.e., the recess). Figure 19A In the image, the outer support layer, such as the outer coil-wound tube layer, is shown as partially transparent.

[0077] Figures 20A-20B Another example of a rigidification device is schematically shown, which includes a recess or channel for a longitudinal arrangement of distal pressure-compression tendons, the recess or channel being located within a layer of the device, such as within an outer support layer or an inner support layer (e.g., a coil-wound support layer, such as an outer coil-wound tube or an inner coil-wound tube). Figure 20A A perspective view of a portion of the rigidification device is shown, including a recess through which a pressure-compression tendon can be supplied. Figure 20B It shows crossing Figure 20A The cross-section of the portion shown.

[0078] Figures 21A-21B An example of a rigidification device is shown, comprising longitudinally arranged recesses through which one or more pressure-compression tendons pass, wherein an outer support layer is made partially transparent to show the recesses. Figure 21B It shows Figure 21A An enlarged view of the distal end region of the rigidification device shown.

[0079] Figures 22A-22B An example of a pair of pressure-compression tendon segments formed from a single monofilament or multifilament is shown, which can be configured as a torsion spring at one or both ends.

[0080] Detailed description Rigidifying the distal end region of a rigidification device that transitions between a flexible and a rigid state is particularly challenging, especially in devices that are highly flexible in their flexible state and transition to a rigid state (or multiple rigid states) with stiffness of one or more orders of magnitude. Pressure-rigidification devices can particularly benefit from the use of a rigidification layer comprising multiple rigidification filaments that intersect and slide relative to each other in their more flexible state, but are compressed and locked together in their rigid state. The distal end region may require both enhanced flexibility and enhanced stiffness. Compared to the proximal region, the distal end region of such a device may require enhanced stiffness because it may withstand higher loads. Compared to the proximal region, the distal end region of such a device may require enhanced flexibility because it may need to flex or bend more with lower applied forces.

[0081] Generally, this document describes rigidification devices, such as apparatuses and systems, including but not limited to endoscopes, catheters, cannulas, guidewires, etc., which may include pressure-compression tendons in a distal end region that preferentially enhance the rigidity of the distal end region. In particular, this document describes methods and apparatuses in which a plurality of pressure-compression tendons extending longitudinally downward along the length of the distal end region are used to rigidify the flexible distal end region of the rigidification device; a second pressure-rigidification layer may be used to rigidify the proximal region of the rigidification device, for example, a plurality of intersecting wire segments. Thus, these apparatuses and methods can maintain high flexibility throughout the rigidification device (particularly including the distal end region) while rigidifying it to a high-rigidity configuration including the distal end region. In some cases, although the entire (proximal and distal) region of the rigidification device can switch between high flexibility and high rigidity states, the device described herein that includes pressure-compression tendons may have a distal end region that provides enhanced rigidity compared to a proximal region actuated using the same pressure.

[0082] In some cases, all or most of the rigidification device segment can be rigidified by multiple pressure-compression tendons. In any of these devices, the proximal end region can be at least partially rigidified using different rigidification layers (such as multiple filaments that intersect each other and can slide relative to each other in a flexible state). Alternatively, only the distal end region can be rigidified by pressure-compression tendons, while the proximal end can be rigidified by a second pressure rigidification layer. These two regions can have a gap between them. These two regions can be adjacent. These two regions can have overlapping regions, and in some cases, the overlapping region can exist between the distal end region (including the pressure-compression tendon) and the proximal region (including the second pressure rigidification layer).

[0083] In some examples, the distal end region may be steerable. In some cases, the pressure-compression tendon may be configured as or may include a steering tendon. Alternatively, in any of these devices, the distal end of the rigidification device is not actively steered.

[0084] Pressure-rigidification devices can dynamically switch between rigid and flexible configurations by applying pressure (including either positive pressure and negative pressure, e.g., vacuum, or both). The methods and devices described herein can be used particularly to increase the flexibility of at least the distal region of these devices without significantly increasing the thickness of the devices and without significantly reducing the overall stiffness achievable by devices in a rigid configuration (including the distal end). The methods and devices described herein can also be used particularly to increase the stiffness of at least the distal region of these devices without significantly increasing the thickness of the devices and without adversely affecting the flexibility achievable by devices in a flexible configuration (including the distal end region). Typically, these devices and methods can include a plurality of pressure-compression tendons (or tendon segments) extending longitudinally along the device, for example along an elongated flexible inner and / or outer support tube, and particularly along the distal end. The pressure-compression tendons can be configured to actuate against another portion of the device, such as the elongated flexible inner and / or outer support tube or some other intermediate portion of the device, by applying pressure (positive or negative pressure) to secure the tendon in place. The pressure can be positive or negative (or in some cases a combination of both). The pressure can be applied by the capsule layer. The pressure-compression tendon can be compressed continuously or intermittently along its segment, either entirely or partially (e.g., the proximal distal region). In some cases, the pressure-compression tendon can also be configured to allow deflection of the distal region when the device is in a flexible (“de-rigidified” state). In any of these examples, the same pressure source as the second rigidification layer can be used to rigidify the pressure-compression tendon.

[0085] Therefore, the devices and methods described herein can provide size-efficient mechanisms that utilize a single-layer tendon for rigidification and, in some cases, for articulation. In some cases, the tendon, referred to herein as a pressure-compression tendon, can be used in conjunction with a rigidification layer (e.g., a "second rigidification layer"), which can be a segment of a mesh, knitted fabric, braided fabric, woven fabric, etc., also configured to be rigidified by applied pressure. In some cases, the distal end region is rigidified by the pressure-compression tendon, while the more proximal region is rigidified by the rigidification layer. In some cases, the two regions can overlap; for example, the pressure-compression tendon can be embedded within the rigidification layer.

[0086] The devices described herein offer a concise mechanical solution that eliminates the need for independent control or shape sensing / end-position control feedback for multiple segments of the deflector section. Furthermore, these methods and devices do not require clamping couplings or other local locking mechanisms because the tendon can be directly compressed by the compression layer. The use of pressure-compression tendons (which, compared to rigidification layers comprising multiple strands intersecting each other, may not intersect and are typically longitudinally oriented, with virtually a very low (or zero) braid angle) provides high flexibility, particularly in the distal regions of the device. In some examples, the use of rigidification layers, which can be highly effective in terms of rigidification, may deform in areas where deflection exceeds 90 degrees or greater (e.g., between 90 and 180 degrees) with a small radius of curvature. The pressure-compression tendons described herein can slide freely longitudinally within a structure (e.g., sheath, channel, tube, etc.) in an unconstrained (flexible) configuration, but can be constrained along the pressure-compression tendon segment in a rigid configuration. Typically, pressure-compression tendons can be configured such that they do not poke or get stuck in the structure of the device.

[0087] Therefore, the devices described herein are configured to allow tight bending radii and rigidified deflection without causing any permanent changes to the flexural properties of the device (which may not be achievable with rigidification layers alone). These devices can deterministically maintain shape (e.g., bending), i.e., simultaneously maintaining both deflection angle and shape. These devices can also advantageously provide a pressure-dependent magnitude of the achieved stiffness; for example, if a normal pressure is applied to rigidify the device, the achieved stiffness can increase with the magnitude of the applied pressure. This is possible because the applied pressure can drive the compression layer against the length of the pressure-receiving tendon, locking the tendon along its entire length, rather than, for example, locking the tendon only in the proximal end region. Unlike other mechanisms used to lock steering or deflecting tendons in place, which can use a drive motor / deflection rod to hold the deflection mechanism at a specific angle (and can allow a larger proximal bending radius and a smaller distal bending radius while maintaining the same deflection angle, thus allowing the end position to drift under load), the methods and devices described herein are configured to lock the tendon's position along its entire or most of its length in a rigid configuration. This configuration allows the device to maintain a specific shape without losing its bending / bending shape, or allows for significant drift in the end position. The pressure-compression tendon described herein can also be configured to prevent or limit buckling and deformation, even when bent to a sharp radius (e.g., in its free state). Therefore, the methods and apparatus described herein can also provide improved control over the deflection of the device and, in some cases, can be used without a drive motor, or with a reduced number of drive motors.

[0088] Compression tendons can be formed as monofilaments or multiple filaments, such as cables. Compression tendons can be formed from any suitable material, such as, but not limited to, polymeric materials (e.g., inelastic polymeric materials such as polycarbonate, polymethyl methacrylate (PMMA), polyethylene, etc.), metallic materials (e.g., metal alloys), or some combination thereof. In some cases, compression tendons can be metallic or polymeric materials. For example, compression tendons can be formed from stainless steel, nickel-titanium (e.g., nitinol), or other materials. Compression tendons can have any suitable diameter, such as stainless steel wire with an OD (Outer Diameter) between approximately 0.001 inches and 0.020 inches (e.g., approximately 0.009 inches, 0.002 inches, 0.003 inches, 0.004 inches, 0.005 inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.09 inches, 0.010 inches, 0.011 inches, 0.012 inches, 0.013 inches, 0.014 inches, 0.015 inches, 0.016 inches, 0.017 inches, 0.018 inches, 0.019 inches, 0.020 inches, 0.025 inches, 0.030 inches, etc.). Compression tendons can be coated. In some cases, compression tendons may be coated with material to increase the grip strength of the compression tendon under compression, while allowing or enhancing slippage. For example, the compression tendon can be coated with a polymer material (e.g., Pebax). In some cases, the compression tendon can be coated with a relatively lubricating material, or it can be contained in a lubricated sleeve, casing, sheath, etc. (e.g., ePTFE / Teflon material). As mentioned above, the compression tendon can be a cable or fiber; the compression tendon can be a monofilament or a bundle of filaments.

[0089] Any of the methods and apparatuses described herein can be used in conjunction with shape sensing, for example, to detect or determine the shape of a device in a flexible and / or rigid configuration. Any of these methods and apparatuses can also be used with one or more closed-loop control algorithms. For example, one or more shape sensors (e.g., EM sensors or shape-sensing optical fibers, etc.) can be used as inputs to the control algorithm to sense the end-effector position and / or orientation. When a force is applied to the end-effector, the control algorithm can use a mixture of tendon tension control (adjusting the axial length of the joint portion) and deflection to attempt to hold the end-effector in its desired position.

[0090] The rigidification devices and methods described herein can be part of a medical access system for diagnosing and treating body areas that are otherwise difficult to access and manipulate, particularly during minimally invasive or non-invasive surgery. In particular, these methods and devices can be used for highly contorted and / or unsupported areas of the body. These methods and apparatuses can be used in combination with rigid (e.g., rigidizable) devices and their methods of use, and / or can modify and improve rigid (e.g., rigidizable) devices and their methods of use, which are described in the following documents: U.S. Patent No. 11,135,398 (titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES"), U.S. Patent Application No. 17 / 604,203 (also titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES"), International Patent Application No. PCT / US2021 / 024582 (titled "LAYERED WALLS FOR RIGIDIZING DEVICES"), and International Patent Application No. PCT / US2021 / 034292 (titled "RIGIDIZING") DEVICES (rigid devices)”, International Patent Application No. PCT / US2022 / 014497 (titled “DEVICES AND METHODS TO PREVENT INADVERTENT MOTION OF DYNAMICALLY RIGIDIZING DEVICES”), International Patent Application No. PCT / US2022 / 019711 (titled “CONTROL OF ROBOTIC DYNAMICALLY RIGIDIZING COMPOSITE MEDICALSTRUCTURES”);U.S. Provisional Patent Application No. 63 / 265,934 (titled "METHODS AND APPARATUSES FOR REDUCING CURVATURE OF ACOLON"), U.S. Provisional Patent Application No. 63 / 296,478 (titled "RECONFIGURABLE STRUCTURES"), U.S. Provisional Patent Application No. 63 / 308,044 (titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES"), U.S. Provisional Patent Application No. 63 / 324,011 (titled "METHODS AND APPARATUSES FOR NAVIGATING USING APAIR OF RIGIDIZING DEVICES"), and U.S. Provisional Patent Application No. 63 / 342,618 (titled "EXTERNAL WORKING CHANNELS FOR") The following documents are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 63 / 335,720 (titled “HYGIENIC DRAPING FOR ROBOTIC ENDOSCOPY”) and U.S. Provisional Patent Application No. 63 / 332,686 (titled “MANAGING AND MANIPULATINGA LONGLENGTH ROBOTICENDOSCOPE”). Alternatively, the apparatus and methods described herein may be used as part of non-medical systems.

[0091] The rigidification devices described herein can be configured to rigidify upon application of negative and / or positive pressure. These rigidification devices can be used in conjunction with other rigidification devices that rigidify using other methods, including those independent of the application of positive or negative pressure. For example, a rigidification device can be configured to include multiple layers arranged within an elongated, tubular body. The device may include a handle or other actuator and may include connections to one or more pressure sources. Pressure applied from the pressure sources can be controlled in various ways, including the operation of a handle or electronically controlled device. Control can result in a pressure differential that allows the device to switch between a highly flexible configuration and one or more (e.g., a continuum) rigid configurations, the highly flexible configuration allowing the tubular body to bend easily when steered or otherwise guided (e.g., on a wire, etc.). In some examples, particularly (but not exclusively) with respect to devices rigidified based on the application of positive pressure, the stiffness of the elongated body is proportional to the applied pressure differential, such that the greater the pressure differential, the more rigid the device can become over at least a certain range of pressure differential values.

[0092] Any of the devices described herein may include pressure-compression tendons extending longitudinally along the device to rigidify a segment of the device, or may include both pressure-compression tendons and a rigidification layer (comprising multiple filaments intersecting each other and configured to shear relative to each other in a flexible state) to rigidify all or part of the device. In particular, it may be especially advantageous to provide a device comprising a distal region and a proximal region, in some cases where the device is rigidified at or near the distal end by means of multiple pressure-compression tendons, and in the proximal region (which may overlap or not overlap with the distal region) by means of a rigidification layer formed by multiple filaments intersecting each other and configured to shear relative to each other in a flexible state.

[0093] Typically, these devices may include multiple layers, including multiple pressure-compression tendon segments located, for example, between a support layer and a compression layer (or, in some cases, embedded within a support layer and a compression layer). The compression layer may be engaged with the multiple pressure-compression tendon segments (and optionally, in some cases, with a rigidification layer). In some examples, the device may include a combined compression layer in which multiple pressure-compression tendon segments are embedded or encapsulated. This document describes pressure-compression tendons that can be particularly well adapted for rapid and precise actuation under a variety of pressures, particularly including normal pressures (e.g., high normal pressures, i.e., about 2 atm or greater, 4 atm or greater, 6 atm or greater, 8 atm or greater, 10 atm or greater, 15 atm or greater, 20 atm or greater, 30 atm or greater, etc.). Any of these devices may also be configured such that at least some of the inner and / or outer layers constituting a rigidification (e.g., rigidifiable) device have different stiffnesses on the inner and outer portions of the inner or outer layer. This document also describes apparatus and methods that include nested rigidification device groups, which may include any one of these rigidification devices.

[0094] Typically, the device described herein may include an elongated flexible internal support tube extending along its length from proximal to distal, extending over the entire (or nearly entire) segment of the device. The elongated flexible internal support tube may be configured to prevent tube collapse. In some cases, the internal support tube is reinforced with one or more supports (e.g., coil-wound tube supports, braids, etc.). For example, the internal support tube may include one or more helical wound filaments (lines, strips, etc.) or annular shapes embedded in a low-stiffness material (e.g., reflow material). In some cases, the internal support tube comprises a laser-cut sodium hypotube. Typically, the internal support tube is configured to prevent collapse under the full range of forces (e.g., pressure) applied to the device. The internal support tube may have an internal cavity opening at both the distal and proximal ends, and the internal support tube may be configured to prevent changes in its inner diameter even when forces (e.g., collapse forces or contraction forces) are applied to the internal support tube.

[0095] Any of these devices may include one or more pressure-compression tendons. These pressure-compression tendons may include multiple pressure-compression tendon segments and may typically extend directly or indirectly along the longitudinal direction of an elongated flexible internal support tube (e.g., separated from the flexible internal support tube by an intermediate layer such as a sliding layer, compression layer, etc.). The pressure-compression tendons may be formed of metallic and / or polymeric materials and may be a single filament or multiple filaments. The pressure-compression tendons may be cables. The pressure-compression tendons may be formed of relatively inelastic materials and may be shaped as relatively inelastic tendons. In some cases, multiple (e.g., two or more) pressure-compression tendons may be formed from a single long strand of material that is itself folded in half (e.g., forming a U-shape or V-shape at one end) to form multiple pressure-compression tendon segments.

[0096] The device described herein may include one or more compression layers configured to compress multiple pressure-compression tendon segments against an elongated flexible internal support tube when pressure is applied. Typically, the compression layers described herein may include one or more structural layers that may be (but are not limited to) sacs and / or sheets of material that apply compressive forces to or against a rigidification layer in response to the application of pressure (e.g., fluid pressure, such as air pressure, saline pressure, etc.) to rigidify the rigidification layer. In examples having both pressure-compression tendons and rigidification layers, in some examples, both pressure-compression tendons and rigidification layers may be rigidified by the same compression layer. Alternatively, in some examples, the device may include more than one compression layer. For example, the pressure-compression tendon may be rigidified by a first compression layer, and the rigidification layer may be rigidified by a second compression layer. If multiple compression layers are used, the multiple compression layers may be actuated by the same pressure source (e.g., actuated together). Alternatively, in some examples, different regions of the device may be actuated separately using different compression layers, thereby allowing selective rigidification along the length of the device.

[0097] Typically, the rigidification devices described herein are configured to change between a rigid and a flexible state by applying or releasing pressure. Any suitable pressure-transmitting medium can be used to apply pressure to drive the compression layer against the pressure-compression tendon and / or the rigidification layer. For example, the pressure-transmitting medium can include liquids (e.g., brine, oil, etc.) and gases (e.g., air, nitrogen, CO2, etc.). The pressure-transmitting medium can be applied to one or more gaps (e.g., pressure gaps) and can be removed actively (e.g., via pumping, suction, etc.) or passively (e.g., via discharge, etc.).

[0098] The apparatus described herein typically includes one or more fluid lines for delivering a pressure-transmitting medium into the apparatus to control rigidification. For example, in any of these methods, the apparatus may include, for instance, an inlet at a proximal end region of the rigidification device, configured to apply or allow pressure to be applied into the apparatus, for example, into a pressure gap, to abut against multiple pressure-compression tendon segments to compress the compression layers.

[0099] For example, Figure 1A An example of a portion (e.g., the distal end region) of a rigidification device is shown, which includes multiple pressure-compression tendons that can be used in the rigidification device. Figure 1A The device is shown in a flexible configuration, in which multiple pressure-compression tendon segments 121, 121', 121'' are shown (shown in a partially transparent view through the main body segment of the device). Figure 1A A cross-section and partially transparent longitudinal view are shown, illustrating the arrangement of the pressure-compression tendons relative to the other layers forming the device. Three pressure-compression tendons are shown. As mentioned above, any suitable number of tendons can be used. For example, four or more pressure-compression tendons (one in each quadrant), five or more pressure-compression tendons, six or more pressure-compression tendons, seven or more pressure-compression tendons, eight or more pressure-compression tendons, nine or more pressure-compression tendons, ten or more pressure-compression tendons, etc.

[0100] like Figure 1A As shown, the pressure-compression tendons extend longitudinally along the inner support tube 115. The pressure-compression tendons may extend in a direction parallel to each other and parallel to the inner support tube segment. Therefore, the pressure-compression tendons can be held or fixed within the tube such that their radial positions (e.g., in the parallel arrangement shown) are relatively fixed. In some cases, the pressure-compression tendons are held within one or more guides (e.g., rings, tubes, channels, etc.) to maintain their radial positions. Such guides may be configured such that a majority (e.g., 50% or more, 55% or more, 60% or more, 65% or more, 70% or more, 75% or more, 80% or more, 85% or more, 90% or more, 95% or more, etc.) of the pressure-compression tendon segment is exposed, allowing the compression layer to compress the pressure-compression tendon segment by applying pressure, thus preventing the pressure-compression tendon segment from sliding under compression. In a flexible configuration, the device may be configured such that the pressure-compression tendons slide freely relative to the inner support tube. For example, the guide may include a lubricated or low-friction surface (coating, etc.) to allow the pressure-compression tendon to move longitudinally relatively unrestrained, unless and until pressure is applied to drive the compression layer against the pressure-compression tendon.

[0101] exist Figure 1AIn this device 100, an internal cavity 120 extends through the device along a proximal-to-distal length direction, for example, through an internal support tube 115. The internal support tube and the internal cavity of the device may be designed to allow one or more tools (e.g., guidewires, manipulators, catheters, endoscopes, etc.) to pass through.

[0102] Figure 1A and Figure 1B The device 100 shown also includes a compression layer 123. The compression layer is typically configured to apply pressure to multiple pressure-compression tendons to allow the device to transition between a rigid and a flexible state. Figure 1A In this configuration, a pressure-compression tendon is located within gap 111, and a compression layer 123 is formed as an outer layer that can collapse by applying negative pressure (e.g., a vacuum) within gap 111. This is in... Figure 1B As shown, the compression layer 123 collapses downward onto the pressure-compression tendons 121, 121', 121'' to prevent the pressure-compression tendons 121, 121', 121'' from moving relative to the internal support tube 115.

[0103] The compression layer can be any suitable layer used to apply force to the pressure-compression tendon (and in some cases, a rigidification layer) to rigidify the device. In some examples, the compression layer is a bladder. The compression layer may have a single sheet or may have multiple sheets (e.g., the compression layer may be flipped back onto itself). In a double compression layer (e.g., an inverted bladder layer), where the compression layer is flipped back onto itself, the internal region between the two walls of the inverted bladder can be pressurized. The compression layer can be configured to conform to the pressure-compression tendon and / or the rigidification layer, such as... Figure 1BAs shown. In this example, a compression layer is wrapped around the pressure-compression tendon to prevent slippage. The compression layer can be configured to be relatively soft and deformable (e.g., elastically deformable). In some cases, the compression layer can be configured to have a stiffness of less than about 90 Shore A (e.g., 80 Shore A or less, 70 Shore A or less, 60 Shore A or less, 50 Shore A or less, 40 Shore A or less, 30 Shore A or less, etc.). Alternatively, the compression layer can be configured not to conform to the pressure-compression tendon and / or the compression layer, but to apply force to the pressure-compression tendon and / or the compression layer. For example, a compression layer can be created such that it pushes but does not significantly deform into a rigidification layer. In some examples, the compression layer comprises an elastomeric (e.g., stretchable) material. In some cases, the compression layer is not an elastomeric material. Therefore, in some cases, it may be surprisingly beneficial if the capsule layer is formed of a flexible / compliant but non-elastic material that does not stretch significantly during use. The compression layer can be configured such that it presses against the tendon of the compression tendon and then deforms or expands around the compression tendon and / or enters or surrounds the filaments of the rigidification layer. For example, the compression layer can be plastic. The compression layer can be a plastic body. The compression layer can be a composite structure. For example, the compression layer can be formed of a material with low tensile strength, which can be an oversized material (e.g., polyethylene terephthalate (PET), nylon, low-density polyethylene (LDPE), or a plastic body). Any of these devices can include, for example, multiple different rigidification regions along a segment of the device, which can be actuated individually or collectively.

[0104] Compression layers can be formed by a variety of methods. In some examples, the compression layer comprises a bladder extruded into a tube. In some examples, the compression layer is formed from a sheet that is produced (e.g., extrusion, solution casting, blow molding, etc.) and then heat-sealed or bonded into a tubular structure. Tubes can be produced, for example, by immersing a mandrel in an elastomer bath or a solvated elastomer bath. Layers can be produced by blowing a film. In this case, the film begins as a bubble of material (typically a plastic or plastide, but sometimes an elastomer), which is stretched or drawn into a tube with high-pressure air behind it, and then transported (usually vertically) as the tube cools, while the tube is limited in diameter. This method provides leak-proof quality control and can produce thinner and less expensive structures. In some cases, as discussed below... Figures 3A-3C As shown, the compression layer is formed on and around the pressure-compression tendon.

[0105] exist Figure 1B middle, Figure 1A A device 100 with a pressure-compression tendon in a locked configuration is shown, wherein by applying negative pressure in the gap 111 region, the compression layer collapses downward onto the pressure-compression tendon and the internal support tube. The gap region can be sealed.

[0106] exist Figure 1A-Figure 1B In this rigidification device 100, a compression layer forms the outer layer. One or more additional layers may be included radially inward to the compression layer and / or pressure-compression tendon and / or internal support tube. For example, a sliding layer may be included to reduce friction between the pressure-compression tendon and the compression layer and / or internal support tube, unless and until the compression layer applies force to the pressure-compression tendon by applying pressure. One or more additional layers may be included radially outward from the compression layer, including an external support tube and / or an outer layer. The outer layer may provide a sterile or sterilizable barrier and / or may be lubricated to aid in insertion / removal of the device from the body.

[0107] While the examples of the devices shown in Figures 1 and 2 can be actuated by applying negative pressure, any of these devices can be actuated by applying positive pressure, for example, changing from a flexible configuration to a rigid configuration. Figures 2A-2B An example of a portion of a rigidification device 200 is schematically shown, comprising a plurality of pressure-compression tendon segments 221 extending longitudinally along an elongated flexible inner support tube 215. The pressure-compression tendons 221 are within gaps 211 (e.g., pressure gaps), and a compression layer 223 extends radially outward from the pressure-compression tendons 221. In this example, eight pressure-compression tendons are shown. An outer support tube 201, which may resemble the inner support tube 215, is radially outside the compression layer 223, the pressure-compression tendons, and the inner support tube. Figures 2A-2B In the example shown, the compression layer is configured as a bladder (e.g., the compression layer is formed by the side of the bladder facing the pressure-compression tendon). Device 200 also includes a gap 211 into which the compression layer can extend when positive pressure is applied to the bladder (the interior of the bladder 224). An external support tube restricts the radial outward extension of the bladder layer and drives the compression layer 223 (e.g., the bladder) against the pressure-compression tendon and the internal support tube 215, thereby rigidifying the device by preventing the pressure-compression tendon from sliding or moving relative to the internal support tube. This... Figure 2A As shown in [the image]. Figure 2B In the middle, the sac 223' is shown as an extended 224' and is driven against the pressure-compression tendon 221 and the internal support tube 215.

[0108] Typically, in any of the devices described herein, the use of a pressure-compression tendon extending along an internal support tube segment (e.g., parallel to the long axis) and the inner cavity 220 of the elongated rigid device may be particularly advantageous where the thickness of the device (e.g., in the flexible and / or steerable distal region) may be limited. In any of these devices, the thickness of the distal end region can be kept low, for example, by limiting the number of layers and / or elements in the distal end region. Thus, the distal end may include a pressure-compression tendon, but not any other rigidification wire or tendon, such as the rigidification layer described herein. This can advantageously increase the flexibility of the device, for example, by allowing the pressure-compression tendon to slide freely when the compression layer is not actuated by positive or negative pressure, and can reduce the overall stiffness of that region by reducing the number of layers.

[0109] A pressure-compression tendon that extends only longitudinally (e.g., parallel to the long axis of the rigidified device), while highly flexible and free to slide in an unconstrained configuration, can rigidify the device when pressure is applied along the pressure-compression tendon segment. Slippage and bending may occur in the rigid state if the pressure-compression tendon is not compressed along its length and for a sufficient portion of its total length by the compression layer. Figure 1A-Figure 1B and Figures 2A-2B In the example shown, the pressure-compression tendon is depicted without any covering or sleeve, allowing the compression layer to contact the continuous pressure-compression tendon segment in the area to be rigidified. As will be described below (reference...) Figures 4A-4C In some cases, the contact between the pressure-compression tendon and the compression layer can be intermittent rather than continuous.

[0110] Figures 3A-3C Another example of a rigidification device including a pressure-compression tendon is shown. As described above, any of these devices may include multiple pressure-compression tendon segments extending along a device segment and capable of free axial sliding. The pressure-compression tendon may be confined or constrained to a radial position around the periphery of the device. In some examples, the pressure-compression tendon may be constrained by a sheath (such as a channel, mesh, network, ring, cover, braid, etc.) that restricts the radial movement of the pressure-compression tendon but does not significantly restrict its ability to move longitudinally when the device is bent or flexed (e.g., during turning). In some examples, a triaxial braid may be used as the sheath, where the freely floating pressure-compression tendon is used for rigidification and / or deflection. Figure 3A The schematic diagram shown illustrates an example of such a device. Figure 3AIn this device, the rigidification device 300 includes a plurality of pressure-compression tendon segments 321, 321'. In any of these devices, all or some of the pressure-compression tendons can be configured for steering. For example, a subset of the pressure-compression tendons can be configured to steer the distal region of the rigidification and can extend along the length of the device to a proximal end where the subset of pressure-compression tendons can be configured to engage with a steering mechanism. These steering pressure-compression tendons can also be used to rigidify the device. Alternatively or additionally, all or a subset of the pressure-compression tendons can be configured for rigidification but not for steering and can be configured to extend only partially (e.g., proximal) along the length of the rigidification device. In some cases, the proximal end of the pressure-compression tendon may not be attached to, for example, a steering assembly or subassembly, and / or may be connected to another pressure-compression tendon.

[0111] exist Figure 3A In this example, the pressure-compression tendons include a first subset 321 of pressure-compression tendons configured to steer them and a second subset 321' of pressure-compression tendons configured to rigidify them. In this example, eight pressure-compression tendons are shown, four of which are steerable and four are rigidified. As described above, steerable pressure-compression tendons can also contribute to rigidifying the device. Figure 3B The area surrounding the steering pressure-compression tendon is shown (in Figure 3A The enlarged view shown in the dashed box 3B is as follows, and Figure 3C The region surrounding the rigidified stress-compression tendon is shown (in Figure 3A The image shown is an enlarged view of (see dashed box 3C).

[0112] exist Figure 3A In this configuration, an internal support tube 315 surrounds an internal cavity 320 and resists compression when the compression layer 323 drives pressure-compression tendons 321, 321' radially inward against the internal support tube to stiffen the device. In this example, the radial movement of the pressure-compression tendons around the device is restricted by fitting them within the compression material forming the compression layer. Each pressure-compression tendon resides within a channel passing through the compression material. The diameter of the channel 344 is larger than the outer diameter of the pressure-compression tendons 321, 321, and may be lubricated to allow relatively unrestricted longitudinal movement of the pressure-compression tendons within the compression material. Therefore, when no pressure is applied to the compression layer, the pressure-compression tendons can slide relatively unrestricted from distal to proximal within the channel formed through the compression material.

[0113] exist Figures 3A-3CIn this design, the section passing through the rigidification device (e.g., the section of the rigidification device rigidified by a pressure-compression tendon) includes an elongated segment of a flexible internal support tube 315. In some examples, the internal support tube 315 is configured with an inner wall braid, which may include one or more braids, coils, etc. In some cases, the internal support tube includes a laser-cut thiocyanate tube configured to have high circumferential strength (e.g., crush resistance) and high flexibility. Therefore, the internal support tube can be optimized for circumferential strength to withstand external pressure and maintain sufficient flexibility. In some examples, the internal support tube includes a braid, for example, woven into a flat wire with a relatively high density (e.g., programmable weft per inch, PPI).

[0114] Any rigidification device described herein may also include an external support tube 301. The external support tube may be similar to the internal support tube. For example, the external support tube may be configured as an outer wall braid. In some cases, the external support tube may comprise a braided material with high tensile strength / stiffness but low flexural stiffness. The external support tube may be optimized for circumferential strength to withstand internal pressure and maintain sufficient flexibility. In some examples, the external support tube may comprise high-PPI aromatic polyamide fibers, such as Technora™ braided material. Any of the external support tubes described herein may include an outer coating or layer 331. In some examples, the outer coating comprises an outer wall return material that may seal or otherwise prevent or reduce contamination without significantly reducing flexibility. In some instances, the outer coating may be a lubricating coating.

[0115] In some examples, the rigidification device may include one or more sheaths that hold the pressure-compression tendons in a radial position around the device body while allowing relatively unrestricted longitudinal (proximal to distal) movement, as described above. Figures 3A-3CAs shown, the pressure-compression tendon may be at least partially covered by a sheath 324, which comprises one or more filaments shown woven around the outer side of the inner support tube above and below the pressure-compression tendon to hold the pressure-compression tendon in a fixed radial position. The sheath forming the braid may be formed of a material with high tensile strength / stiffness but low flexural stiffness, such as aramid fibers, e.g., Technora™. As mentioned above, the braid may be a high PPI braid. The sheath is typically configured to collapse onto the tendon under external pressure (allowing for rigidification via actuation of the compression layer). Therefore, there may be no gaps around the pressure-compression tendon during rigidification, but it may be relatively loose when the compression layer is not driven by applied pressure. When the main body of the device is bent, or when it is actively bent, for example by pulling one or more steering tendons (which may include or be a subset of pressure-compression tendons), or when it is passively bent, for example by sliding on a rigid / rigidified internal component (e.g., conduit, wire, etc.) with a bent or folded shape, the sheath prevents radial movement of the pressure-compression tendons due to the application of tensile loads. Figures 3A-3C The sheath may also include a soft material (e.g., a low-hardness material, such as a material with a hardness of 60 Shore A or lower, 55 Shore A or lower, 50 Shore A or lower, etc.) that at least partially encapsulates at least a portion of the pressure-compression tendon, as described above. In some cases, the sheath material may act as a compression material and may flow back on and around the inner wall. The low-hardness material can minimize bending stiffness. In some examples, the material may have sufficient viscosity to hold the pressure-compression tendon when driven against it by applied pressure. In some examples, the sheath material (e.g., a low-hardness material) may also help prevent permanent damage to the structure when the device is bent or moved.

[0116] exist Figures 3A-3CIn this context, pressure-compression tendons comprise a subset of pressure-compression tendons configured as steering or yaw tendons. As described above, any suitable material can be used for pressure-compression tendons, including steering / yaw tendons. For example, pressure-compression tendons can typically be axially rigid cables with a low-friction coating, such as tungsten cables with a PTFE coating. Pressure-compression tendons can also include a subset of tendons configured not to be configured for steering. Pressure-compression tendons can be very flexible wires or cables that provide axial support when constrained. For example, rigid tendons can be, for instance, stainless steel wire with an OD of 0.009 inches. Rigid tendons can increase the system's resilience when free and can also increase yaw force, and can be coated to provide low dynamic friction when free and high static friction when compressed. In some examples, the rigid tendon may be covered / coated with Pebax heat-shrinkable material (e.g., see https: / / chamfr.com / product / heat-shrink-pebax-72d-21-clear-0-014-exp-id-quantity-6-bag-p2-014-002-clr / ). The tendon, especially the rigid tendon, can be cable or fiber. In some examples, the tendon is a solid wire.

[0117] exist Figures 3A-3C The device includes eight pressure-compression tendons, four of which are configured as steering / deflection tendons and the other four as rigid tendons. Figure 3B An enlarged view of the area surrounding the steering / deflection tendon is shown, and Figure 3C An enlarged view of the area surrounding the rigidified tendon is shown. Therefore, a subset of the pressure-compression tendon can be optimized for a specific purpose. In some examples, the same tendon can be used for both deflection and rigidification. As mentioned above, in some examples, the tendon may be coated with, for example, a lubricating coating. In some examples, any areas of lubricating coating on the tendon can be removed, for example, by laser ablation, to enhance friction between the tendon and the compression material / compression layer. Alternatively or additionally, a coating with higher friction can be applied to these areas.

[0118] exist Figures 3A-3C In this configuration, the pressure-compression tendon is located on the inner wall and is rigidified by inward compression, for example, by applying pressure to the pressure gap 311. In some examples, the tendon may alternatively be embedded in the outer wall and compressed outward (e.g., the pressure gap 311 may be located between the inner support tube and the pressure-compression tendon). This configuration maximizes the bending moment that can be applied to the tendon and can provide axial stiffness while minimizing stretching / wrinkling during rigidification.

[0119] Figures 3A-3CThe example shown can be rigidified by applying positive pressure. For example, pressure applied to pressure gap 311 can drive compression layer 323 against soft sheath material 324, 235 and can clamp or compress the pressure-compression tendon. The pressure-compression tendon can then act as fibers embedded within the wall, resulting in a significant increase in stiffness, thereby locking (rigidifying) the shape. Release of pressure causes the material to stretch outward, allowing the pressure-compression tendon to slide and regain flexibility. Functionally, it can operate in the same manner as rigidification using a rigidification layer (e.g., a braided layer), as described below. Figures 7A-7B and Figures 8A-8B A more detailed description follows. Before pressure is applied, the pressure-compression tendon can slide longitudinally (although radial movement is restricted), resulting in relatively low stiffness. While pressure is applied, the pressure-compression tendon is locked in place; in some cases, the greater the applied normal pressure, the stronger the locking force. This effect can be amplified (compared to rigidification layers) when using pressure-compression tendons because, even in a flexible configuration, the pressure-compression tendon is limited to movement in the longitudinal (proximal to distal) direction.

[0120] In addition to locking by applying pressure to compress the pressure-compression tendon, in some examples, the steering tendon (a separate set of tendons and / or a subset (or all) of the pressure-compression tendons) can be locked in place using one or more drive motors or yaw rods. For example, the steering / yaw tendons can be fully tensioned together; this will not move the vehicle, but keeping sufficient steering / yaw tendons under tension at the same time can prevent steering and can rigidify the steerable area. In some examples, this can also be used in addition to pressure rigidification.

[0121] Steering / deflection tendons can be manually and / or robotically driven. For example, steering / deflection tendons can be driven by motors to provide joint movement and can be rigidified by pressure locking in place. Therefore, using pressure-compression tendons for rigidification and steering, at least in a portion of the device, can save space and reduce device OD (and / or increase ID). In any of these devices, a minimal number of drive motors can be used for tendon control. For example, in some examples, two motors can be used per deflection plane to provide smooth, precise control when reversing direction; for example, an antagonistic tendon can “drive” the mechanism by deflection. In some examples, one motor can be used per deflection plane, and the device can spring back to a straight, neutral configuration, where the tension tendon is released to accommodate the neutral configuration.

[0122] Figures 4A-4C An example of a rigidification device 400 is shown, which includes a plurality of pressure-compression tendons extending longitudinally downward along the length of the device and a compression layer that may include the pressure-compression tendons to rigidify the device. Figure 4A A rigid device 400 in an unrigidified configuration is shown assembled. The device can be flexibly bent or turned, for example, by pulling one or more pressure-compression tendons (in this example) that extend along the length of the device from the proximal to the distal side.

[0123] Figure 4B It shows Figure 4A The device includes an outer layer comprising a compression layer to expose a pressure-compression tendon extending from a flexible segment of the device. The pressure-compression tendon is shown extending longitudinally on an elongated flexible inner support tube 415 configured to include an inner coil winding tube with a plurality of coils having high circumferential strength, on which a flexible, relatively low-stiff polymer material has flowed back into the gaps between the coils.

[0124] exist Figures 4A-4CIn this device, the pressure-compression tendon has multiple discrete exposed areas 433 along the pressure-compression tendon segment, the multiple discrete exposed areas 433 being separated by multiple tubular channels 434 within which the pressure-compression tendon can slide. The channels can be coupled or radially constrained to the exterior of an internal support tube 415, and the pressure-compression tendon can slide relatively freely within the channels. Intermittent openings 433 along the pressure-compression tendon segment can allow the device to be compressed and contact the compression layer to rigidify the device. Although the channels 434 can also be compressed and can collapse onto the pressure-compression tendon to aid in rigidification, providing multiple exposed openings along the segment to clamp and lock the pressure-compression tendon may be particularly advantageous. Therefore, any of these devices may include multiple pressure-compression tendon segments located along the device segment within multiple guides / tubes; the guides / tubes may form multiple openings along the device segment exposing the pressure-compression tendon. For example, the percentage of exposed pressure-compression tendons (e.g., for contact with the compression layer) can be greater than about 30% (e.g., 30% or more, 35% or more, 40% or more, 45% or more, 50% or more, 55% or more, 60% or more, 65% or more, 70% or more, 75% or more, 80% or more, etc.). Typically, the exposed surface of the pressure-compression tendon provides the contact surface area between the pressure-compression tendon and the compression layer; in some cases, it is desirable to increase this surface area to increase the rigidity of the device in a rigid state, for example, to prevent slippage. In some examples, the tubular channel 434 can be separated to form an exposed area extending about 0.5 mm to 10 mm or more along the rigidified section of the device. In some cases, the tubular channels 434 may be spaced approximately every x mm, where x is between about 0.5 mm and about 20 mm or greater (e.g., between about 0.5 mm and about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 7 mm, 10 mm, 12 mm, 15 mm, 17 mm, 20 mm, 22 mm, 25 mm, 30 mm, etc.). When the device is in a flexible configuration, the space between the channels (“exposed areas”) can also enhance the flexibility of the device and prevent these sheaths (tubular channels) from clumping together.

[0125] Figure 4C It shows a rigid configuration Figure 4A The device contains a pressure that is maintained to keep the device 400' in a rigid state. The pressure can be released to restore the device to a flexible configuration. Port 465 is shown on the proximal end.

[0126] Figure 4DAn example of a pair of nested rigidification devices 450, 460 is shown, the pair of nested rigidification devices 450, 460 including at least one rigidification device, the at least one rigidification device including a pressure-compression tendon as described herein.

[0127] Figure 5 A method of operation of a rigidification device using multiple pressure-compression tendons as described herein is schematically illustrated. The device may initially be positioned within the body (in variations for medical indications), for example, in a flexible configuration. In some cases, the device may be inserted onto or within a guide (e.g., a guidewire, guide sleeve, etc.). In step 501, the distal end region of the device can be manipulated by rigidifying the device, such that the distal end region bends when in a flexible configuration. The rigidification device can be any rigidification device described herein, including rigidification devices having an elongated flexible internal support tube extending in a proximal-to-distal length direction. The device can be operated in a flexible configuration for positioning within the body or relative to another device (including another rigidification device), which may, for example, be inserted into or pass through the lumen of the rigidification device. In some examples, all pressure-compression tendons or a subset thereof may be used to steer the device when in a flexible configuration. Alternatively or additionally, the device may be passively steered in a flexible configuration by tracking or following the shape of another device inserted into the central lumen of the rigidification device.

[0128] Then, in step 503, the rigidification device can be rigidified by applying pressure (positive pressure, negative pressure, or in some examples, any one or both of positive and negative pressure) to compress multiple pressure-compression tendon segments extending longitudinally along the device (in some examples, along an elongated flexible internal support tube). The applied pressure can be maintained to hold the rigidification device in a rigid configuration. The amount of applied pressure can be adjusted to regulate the stiffness of the device. Pressure can be applied by applying positive pressure when a fluid (e.g., air, nitrogen, water, brine, etc.) is applied to the pressure gap of the device. Pressure can be maintained actively (e.g., by maintaining the pressure within a target range) or passively (e.g., by sealing the pressure inlet and / or passage to maintain pressure).

[0129] Pressure can be maintained to keep the device in a rigid configuration for a desired period of time. Thereafter, in step 505, the pressure can be released to convert the rigid device back to a flexible configuration. This process can be repeated frequently as needed, for example, switching between flexible and rigid configurations.

[0130] Hybrid rigid equipment This document also describes a device comprising a first region (e.g., a distal region) and a second region (e.g., a proximal region), the first region being rigidified using a plurality of pressure-compression tendon segments, and the second region being rigidified using a second mechanism (e.g., a rigidification layer). The rigidification layer may extend as a layer within the device, including adjacent elongated flexible internal support tubes. The rigidification layer may be rigidified by pressure, including by the same (or in some cases different) rigidification layer used to rigidify the pressure-compression tendon segments. The rigidification layer may comprise a plurality of filament segments that intersect each other vertically and are configured to shear relative to each other. The first region may be separate from the second region (and may be adjacent to a second repellent or separated by a gap), or the first and second regions may overlap.

[0131] For example, Figures 6A-6C An example of a hybrid rigidification device is shown, comprising both a plurality of pressure-compression tendon segments and a rigidification layer. The plurality of pressure-compression tendon segments rigidify a first region and the rigidification layer, the rigidification layer comprising a plurality of filament segments intersecting each other vertically. Figures 6A-6C In the middle, the first region is adjacent to the second region.

[0132] Figure 6A An example of a device including a first distal region 645 is shown, which includes a plurality of pressure-compression tendons 621 extending from a proximal end (not shown) to a distal end 620. In the distal region 645, the pressure-compression tendons 621 can be rigidified as described above, for example, by abutting against an elongated flexible inner or outer support tube driven by a compression layer (e.g., a bladder) of a compression assembly. Figure 6A In the middle, the long, flexible internal support tube is not visible, but the tendon (passing through the outer layer of the device) is shown by the dashed line. Figure 6A It also includes a proximal region configured to be rigidified by a rigidification layer 609 comprising a plurality of filaments that intersect each other vertically and are configured to shear relative to each other when the device is in a flexible configuration. Figure 6A The pressure-compression tendon in the middle can overlap with the rigidification layer in the second section 647, and can be on top of, below or through the elongated flexible internal support tube in the second region.

[0133] Figure 6B Another example of a device including a first rigidification region is shown, which is rigidified by a plurality of pressure-compression tendons 621' extending longitudinally along a distal end region (e.g., along a portion of an elongated flexible internal support tube), but not extending into a second region 647 including the rigidification layer 609. In this example, the pressure-compression tendons are configured for rigidification and flexibility only, but not for actively bending or guiding the distal end region, which is consistent with... Figure 6A and Figure 6C The example shown is different. Bending or guiding the distal region can be achieved by another element, for example, by an element acting from within the central bore or from the outside of a large diameter. In this example, multiple pressure-compression tendon segments can extend substantially parallel to each other and parallel to the long axis of the device, but terminate before the second region. Therefore, Figure 6B The pressure-compression tendon of the rigidification device shown is configured as a rigidification tendon.

[0134] Figure 6C An example of a rigidification device (e.g., a rigidification apparatus) is shown, which includes a distal region 645 having a plurality of longitudinally extending pressure-compression tendons and having a similar Figures 6A-6B The near-side region 647 of the rigidification layer is shown. Figure 6C In the configuration, multiple pressure-compression tendons include a first subset 621' of rigid pressure-compression tendons, which is not configured to steer the distal end region (or is not configured for active steer) because the first subset only partially extends downwards into the device segment, and a second subset 621 of pressure-compression tendons, which is configured to steer (e.g., steer / deflection tendons) extending the entire elongated body segment of the device to the proximal end, where the second subset can be controlled (pulled and / or pushed) to steer the distal region. This configuration is similar to Figures 3A-3C The arrangement of the pressure-compression tendons is shown in the figure.

[0135] Figure 6D It shows the relationship with Figure 6B Examples of rigidification devices similar to the rigidification device shown include a pressure-compression tendon 621'' confined to a first (e.g., distal) region 645, and a second region 647 rigidified by a rigidification layer. Figure 6D The pressure-compression tendons in the device are formed as multiple pressure-compression tendon segments, which are adjacent to each other, parallel to each other, and extend parallel to the long axis of the device. However, at least pairs of pressure-compression tendon segments may be joined at their proximal ends (in an approximately "U" or flattened "U" shape). In this case, such a connection between two adjacent pressure-compression tendons may be within a first region 645, at the interface between the first and second regions, or in a second region 647, and may prevent the ends of the pressure-compression tendons from piercing the wall of the device or otherwise damaging adjacent components. Alternatively, in any of these devices, the ends of the pressure-compression tendons may be passivated and / or encapsulated in a material (e.g., a cap or other covering structure covering the free end of each pressure-compression tendon) to prevent them from piercing the wall of the device.

[0136] Figure 6EAn example of a device including a first distal region 645 is shown, which includes a plurality of pressure-compression tendons 621, as described above. The pressure-compression tendons 621'' extend from the distal end to a more proximal region within a proximal region 647. The proximal region includes a second rigidification layer 609, such as a plurality of filament segments that cross each other (as in a woven, knitted, or woven fabric, etc.) and can slide freely when in a flexible configuration. The pressure-compression tendons 621 overlap into this proximal region in an overlapping region 649. Therefore, both the distal region 645 including the pressure-compression tendons 621 and the proximal region including the second rigidification layer 609 can be rigidified as described above, for example, by abutting against an elongated flexible inner or outer support tube (e.g., an inner or outer coil-wound tube) driven by the compression layer (e.g., a bladder). Figure 6E In the middle, the support tube is not visible. The overlapping region 649 between the pressure-compression tendon and the second rigidification layer can be of any suitable length, for example, between about 1 mm and about 20 cm (e.g., between about 1 mm and 18 cm, between about 5 mm and 18 cm, between about 1 cm and 17 cm, between about 1 cm and 16 cm, between about 1 cm and 15 cm, between about 1 cm and 14 cm, between about 1 cm and 13 cm, between about 1 cm and 12 cm, between about 1 cm and 11 cm, between about 1 cm and 10 cm, between about 1 cm and 9 cm, between 1 cm and 8 cm, between about 1 cm and 7 cm, between 1 cm and 6 cm, between 1 cm and 5 cm, between 1 cm and 4 cm, between 1 cm and 3 cm, etc.). Within the overlapping region 649, the pressure-compression tendon may be on top of, below, or through the second rigidification layer. In any of these devices and methods, the pressure-compression tendon may be within a compressible sleeve, channel, tube, etc., or may be uncovered over all or part of its segment (e.g., without a sleeve). In any of these devices, the pressure-compression tendon may be located within a channel formed in an inner or outer support layer (or both), for example, within an inner coil-wound tube and / or an outer coil-wound tube.

[0137] The first (e.g., distal) region that can be rigidified by pressure-compression tendon can be of any suitable length, and the second (e.g., proximal) region can be of any suitable length. For example, the distal region can be between approximately 1cm and 30cm, between approximately 1cm and 28cm, between approximately 1cm and 27cm, between approximately 1cm and 26cm, between approximately 1cm and 25cm, between approximately 1cm, between approximately 2cm and 25cm, between approximately 2cm and 24cm, between approximately 2cm and 23cm, between approximately 2cm and 22cm, between approximately 1cm and 21cm, between approximately 2cm and 20cm, between approximately 1cm and 18cm, between approximately 1cm and 17cm, between approximately 1cm and 16cm, between approximately 1cm and 15cm, between approximately 3cm and 15cm, between approximately 3cm and 14cm, between approximately 3cm and 13cm, between approximately 3cm and 12cm, between approximately 3cm and 11cm, between approximately 3cm and 10cm, between approximately 3cm and 9cm, between approximately 3cm and 8cm, between approximately 3cm and 7cm, between approximately 3cm and 6cm, between approximately 3cm and 5cm, etc. The proximal region can be 5 cm or longer (e.g., 10 cm or longer, 15 cm or longer, 20 cm or longer, 25 cm or longer, 30 cm or longer, 35 cm or longer, 40 cm or longer, 45 cm or longer, 50 cm or longer, etc.). In some examples, the proximal region can be much longer than the distal region (e.g., 1.5 times or more, 2 times or more, 2.5 times or more, etc.).

[0138] As described above, any of these devices may include a second rigidification layer along the entire segment of the device (e.g., both the distal and proximal end regions), and the pressure-compression tendon may extend only in the distal end region. For example, as Figure 6F As shown. In this example, tendon 621'' extends only in the distal region 645' and completely (or mostly) overlaps with the second rigidification layer 609.

[0139] In any of the devices described herein, including but not limited to Figures 6A-6D Those shown. The rigidification layer can be formed by the following steps, in which multiple filaments intersect each other vertically and are configured to shear relative to each other when in a non-rigidification configuration, as described above. Figures 7A-7B and Figures 8A-8B An example of a rigidified region in a device including a rigidification layer is shown. Any of these devices may include a rigidified region similar to... Figures 7A-7B and Figures 8A-8B The regions of those rigidified layers shown.

[0140] For example, Figure 7AAn example of a cross-section through an elongated rigidification device configured to be rigidified by a rigidification layer is shown, illustrating an arrangement of a plurality of layers that may be included. In this example, the rigidification device 700 is configured to be actuated by applying negative pressure (e.g., vacuum). The device 700 shown includes a reinforceable inner layer (715) (e.g., by including one or more reinforcing members, such as spirally arranged strips, belts, wires, etc., which may be braided and / or formed into loops / coils, etc.), an optional sliding layer (713), a pressure gap (711), a rigidification layer (709) configured as a braided layer in this example, a second pressure gap (707), and an outer layer (701). In some examples, a vacuum may be applied between the outer and inner layers for rigidification. For example, a port configured to be coupled to a negative pressure source may be located at a proximal end of the device and may be in fluid communication with a gap region 707 between the flexible outer layer 701 and the rigidification layer 709 (e.g., the braided layer). Thus, in this example, the outer layer may act as a compression layer. These layers are tubular structures surrounding an internal cavity 720. Figure 7B A cross-section of a wall region B passing through the cylindrical body of the device is shown. Applying suction can allow the outer layer 701 to be pulled onto the rigidification layer, thus rigidifying it and limiting or preventing bending of the device.

[0141] Another example of the rigidizable device 2100 is in Figures 8A-8B As shown in the image. In this example, the device could also be elongated, such as a conduit or tubular device, similar to... Figures 7A-7B The equipment in the middle can be rigidified by applying positive pressure. For example, Figure 8A A cross-section transverse to the long axis of the elongated rigidifiable device is shown. In this example, the layers forming the device are arranged such that the inner reinforcing layer 2115 is the most radially inward layer and can be reinforced, for example, by helically wound tape, strips, cables, etc. The device may also include an optional sliding layer 2113, which can reduce friction between the inner layer and the more radially outward layers. The sliding layer can be powder, or it can be a lubricating layer or a lubricating material layer. A first gap layer 2112 is shown to separate the inner layer 2115 and / or the sliding layer 2113 from the compression layer, which in this example is configured as a capsule layer 2121. A second (or intermediate) gap layer 2111 separates the capsule layer from the rigidification layer 2109, which in this example is shown as a braided layer. A third gap layer 2107 is located between the rigidification layer and the outer layer 2101. In this example, the outer layer (similar to the inner layer 2115) is reinforced, for example, by helically wound filaments, threads, fibers, tapes, etc. Although not shown, when actuated by applying positive pressure between the compression (e.g., capsule) layer and the inner layer, the capsule layer can push the braided layer into the outer layer to rigidify the rigidification layer. The device includes an internal cavity 2120.

[0142] Figures 7A-7B and Figures 8A-8B The two examples of the devices shown may include additional optional layers or components. Furthermore, the composition of the rigidification layer can be modified to improve performance. In particular, the rigidification layer can be modified to include structures that can enhance or improve performance (e.g., knitted fabrics, woven fabrics, braids, scales, plates, filament arrays, granules, and combinations thereof). Rigidification elements can be used alone as a type or in combination with other rigidification elements. In some examples, the inner and / or outer layers can be modified to enhance or improve performance, including adding torsion control components and / or adjusting the stiffness of the inner and outer regions of these layers.

[0143] Figure 9 A method of operating a rigidification device is schematically illustrated, the device comprising a first region rigidified using multiple pressure-compression tendons and a second region rigidified using a rigidification layer, as described herein. The device may initially be positioned within the body (in variations for medical indications), for example, in a flexible configuration. In some cases, the device may be inserted onto or within a guide (e.g., a guidewire, guide sleeve, observation instrument, outer sheath, etc.). In step 901, when the device is in a flexible configuration, the device may be actively or passively steered such that the device, along with the distal and proximal regions, bends together. The rigidification device can be any rigidification device described herein, including... Figures 6A-6D Any rigid device shown. The device can operate in a flexible configuration for positioning within the body and / or relative to another device (including another rigid device), which may, for example, be inserted into or pass through the cavity of the rigid device. In some examples, all pressure-compression tendons or subsets thereof can be used to steer the device when in a flexible configuration. Alternatively or additionally, the device can be passively steered in a flexible configuration by tracking or following the shape of another device inserted into the central cavity of the rigid device.

[0144] Then, in step 903, the rigidification device can be rigidified by applying pressure (positive pressure, negative pressure, or a combination of positive and / or negative pressure in some examples) to the distal and proximal regions; in the proximal region, this may cause the compression layer to compress multiple pressure-compression tendon segments extending longitudinally along the proximal region of the device (in some examples, along an elongated flexible internal support tube in the proximal region) and abut against the same or different compression layers in the proximal region to compress the rigidification layer, thereby rigidifying the rigidification device. The applied pressure can be maintained to keep the rigidification device (proximal and distal regions) in a rigid configuration. The amount of applied pressure can be adjusted to adjust the stiffness of the device. Pressure can be applied by applying positive pressure when a fluid (e.g., air, nitrogen, water, brine, etc.) is applied to the pressure gap of the device. Pressure can be maintained actively (e.g., by maintaining the pressure within a target range) or passively (e.g., by sealing the pressure inlet and / or channel to maintain pressure).

[0145] Pressure can be maintained to keep the device in a rigid configuration for a desired period of time. Thereafter, in step 905, the pressure can be released to convert the rigid device back to a flexible configuration. This process can be repeated frequently as needed, for example, switching between flexible and rigid configurations.

[0146] Nested devices Typically, any rigidifiable device described herein can be configured as a nested device, which can be nested to provide enhanced performance. For example, a nested device (system) may include similar to Figures 6A-6D The external rigidification devices shown herein, as well as internal rigidification devices, can be configured as rigidification mirrors; the two rigidification devices can move axially and rotationally relative to each other. In some examples, the two rigidification devices can move concentrically, but in some configurations, they can be arranged non-concentrically. The external and internal rigidification devices can include any rigidification features described herein. For example, external rigidification device 301 can include a distal end of tendon rigidification and a proximal end rigidified by a rigidification layer.

[0147] Internal rigidification devices (e.g., observation instruments) can be configured, for example, to receive positive and / or negative pressure for rigidification. Any of these rigidification devices, including internal rigidification devices, may include air / water channels and working channels, as well as a shape sensing system that may extend along with the internal and / or external rigidification devices. Additionally, any of these rigidification devices (including internal and / or external rigidification devices) can include a distal section with a camera and a lamp, and may be steerable. In some cases, the steerable distal end may be steered using any pressure-compression tendon as described herein. Alternatively or additionally, one of the nested devices may include a steerable end with a linkage. In another example, the camera and / or lighting equipment may be delivered in separate components (e.g., the camera and lighting equipment may be bundled together in a conduit and delivered downwards along the working channel and / or additional working channels to the distal end). Features of any of these devices may include or be incorporated into a device comprising a flexible external working channel (as described in PCT patent application No. PCT / US2023 / 067072, entitled “EXTERNALWORKING CHANNELS FOR ENDOSCOPIC DEVICES”, filed May 16, 2023). This external working channel is incorporated herein by reference in its entirety.

[0148] The inner cavity of the first external rigidifiable device can form a gap or interface, within which the second internal rigidifiable device can be positioned. This gap or interface region can have any suitable size such that, when inserted into the first external rigidifiable device, an annular space (d) remains around the second internal rigidifiable device. In some examples, when the internal rigidifiable device is centered within the cavity of the external rigidifiable device, the space (e.g., radial clearance) on either side of the internal rigidifiable device can be between approximately 0.001” and 0.050”, such as 0.0020”, 0.005”, or 0.030” wide. The inner surface of the external rigidifiable device and / or the outer surface of the internal rigidifiable device can be low-friction surfaces and can include, for example, powders, coatings (e.g., hydrophilic or hydrophobic) or laminations to reduce friction. In some examples, a seal can be present between the internal device and the external rigidifiable device, and the intermediate space can be pressurized, for example, with fluid or water to create hydrostatic support. In other examples, a seal can be present between the internal and external rigidifiable devices, and the intermediate space can be filled with small spheres to reduce friction.

[0149] The internal and external rigidifiable devices can move relative to each other and be rigidified alternately to transmit bending or shaping downwards along the length of the nested system. For example, the internal device can be inserted into a cavity and bent or turned into a desired shape. Pressure can be applied to the internal rigidifiable device to cause the rigidification layer to rigidify the internal rigidifiable device in any configuration with curved bending when pressure is applied. The rigidifiable device (e.g., in a flexible state) can then be advanced on the rigid internal rigidifiable device. When the external rigidifiable device is fully advanced relative to the internal rigidifiable device, pressure (e.g., positive or negative pressure) can be applied to the external rigidifiable device to rigidify the rigidification layer, thereby fixing the shape of the external rigidifiable device. The internal rigidifiable device can be transformed to a flexible state, advanced, and the process repeated. Although the system is described as including an internal rigidifiable device configured as an observation instrument, it should be understood that other configurations are possible. For example, the system may include two outer sheaths, two conduits, or a combination of outer sheaths, conduits, and observation instruments.

[0150] Figures 10A-10H Nested systems 1000 and methods of operating them are shown and described in a generally illustrated manner that can be performed using any of the rigidifiable devices described herein. In these examples, the external rigidification device 1001 may be rigidified and may include a steerable distal end that is rigidified and / or steered using a pressure-compression tendon at the distal end. In some cases, the proximal end may be rigidified using a rigidification layer as described above. The internal rigidification member 1003 may also include a distal region that can be rigidified by a pressure-compression tendon and a proximal rigidifiable region including a rigidification layer. The external rigidification device may be actively steered (e.g., using a steering / deflection tendon) or passively steered.

[0151] refer to Figures 10A-10H The example nested device shown can be rigidified by any suitable method, including but not limited to applying positive and / or negative pressure to one or both rigidifying members. Modifications to the rigidifying members, torsional stiffness, and / or rigidity of the inner and / or outer (tube) layers of these rigidifiable devices can be performed in a manner similar to... Figures 10A-10H The method shown provides enhanced mobility and functionality for the nested devices described herein.

[0152] Indications and Usage The devices (equipment, systems) described herein can be used in any suitable body region. For example, these devices can be configured as catheters, sheaths, observation instruments (e.g., endoscopes), filaments, cannulas, cannulas, needles, or laparoscopic instruments and / or can be included as part of a pair of nested devices (one or more of which are rigidifiable). For example, any device described herein can be configured for use in one or more of the following: the neurovascular system (e.g., aortic arch, subclavian, carotid artery, spine, basal region, posterior brain, Willis ring, midbrain, forebrain, etc.), the upper GI tract (oropharynx, stomach, pylorus, bile duct, and pancreatic duct, etc.), the small intestine (e.g., small intestine, duodenum, jejunum, iliac crest, etc.), the lower GI tract (rectum, colonic region, e.g., sigmoid colon, descending colon, transverse colon, ascending colon, cecum, ileocecal valve, etc.), and the urinary tract. (urethra, bladder, kidneys, ureters, etc.), peripheral vascular system (e.g., femur, iliac, mesentery, lumbar vertebrae, kidneys, celiac trunk, liver, chest, etc.), cardiac region (e.g., aorta, right coronary artery, left coronary artery, etc.), left heart (e.g., aorta, aortic valve, left ventricle, etc.), right heart (e.g., vena cava, right atrium, left atrium, mitral valve, coronary sinus, tricuspid valve, right ventricle, pulmonary valves, pulmonary vascular system, etc.) and / or right lung region (e.g., mouth, larynx, trachea, pulmonary vascular system, etc.).

[0153] Therefore, any apparatus (and methods of using them) described herein can be used with or as part of catheters, endoscopes (including, but not limited to, colonoscopes, bronchoscopes, colposcopes, cystoscopes, esophagoscopes, gastroscopes, laparoscopes, thoracoscopes, colonoscopes, etc.), cannulas, etc. These apparatuses and methods can be used with robotic systems, including robot-controlled endoscopes. Robotic systems can be mechanically steered and / or propelled. Systems can be used with both manual and robotic elements. In some examples, a robotic system can control the operation (e.g., advance, retraction, and / or actuation) of one or more tools to be used within an external working channel, including any tools or tool pairs described herein. Any apparatus described herein can be used with robotic systems, including robotic endoscope systems.

[0154] Variant Unless the context otherwise specifies, any apparatus and method described herein can be configured to be rigid by applying positive pressure (including relatively high pressures, such as up to 4 atm, 5 atm, 6 atm, 7 atm, 8 atm, 9 atm, 10 atm, 30 atm, 50 atm, etc.)). Alternatively, unless the context otherwise explicitly specifies, any apparatus described herein can be configured to be rigid by applying negative pressure (e.g., vacuum / suction). Similarly, any of these apparatuses and methods may include the following regarding... Figures 12A-12I , Figures 13A-13B , Figures 14A-14B , Figures 15A-15E , Figures 16A-16F , Figures 17A-17B , Figures 18A-18B , Figures 19A-19B , Figures 20A-20B , Figures 21A-21B and 22A- Figure 22B Any variations shown and described.

[0155] As described above, in any of these devices, at least the distal end region is configured to include a plurality of pressure-compression tendon segments. The pressure-compression tendons can act on a region (e.g., the distal region) or the entire segment. In some examples, the pressure-compression tendons are formed by a plurality of distinct individual tendon segments extending over at least discrete portions of the segment, such as over the distal end region. The pressure-compression tendons can be arranged as a plurality of long (e.g., full-length) pressure-compression tendons extending over the device segment, or can include a plurality of shorter longitudinal pressure-compression tendon segments extending in multiple longitudinal portions, such as... Figures 13A-13B and Figures 14A-14B As shown.

[0156] In some examples, the pressure-compression tendon is a discrete or semi-discrete element, such as... Figure 12A , Figure 12F and Figure 12G As shown. In some examples, the pressure-compression tendon can be a single tendon segment, such as... Figure 12A As shown. In some cases, pressure-compression tendon assemblies can be formed by discrete tendon segments, such as... Figure 12F and Figure 12G As shown. In Figure 12F In this device, paired pressure-compression tendon segments are formed by U-shaped tendons. Other shapes can be used, including but not limited to V-shapes, square shapes, etc. In any of these examples, the ends of the tendons can be configured to be non-traumatic to prevent puncture of any layer of the device. For example, the ends of the pressure-compression tendons can be blunt (e.g., formed into a ball or otherwise provided with end caps). In some cases, the ends of the pressure-compression tendons can be attached to a retainer or structure (e.g., a ring, etc.) or combined with layers (e.g., a wire of a second rigidification layer) for example by welding, fusion, or other means to prevent them from damaging the device and / or injuring the patient. In some cases, the ends can move freely within the device (e.g., slide longitudinally). In some cases, such as in... Figure 12F In this process, the free ends of these pressure-compression tendons can be positioned distally and can be connected to end caps or rings at the distal end region.

[0157] exist Figure 12G In this context, the pressure-compression tendon is formed by bending segments that can be oriented in alternating directions (e.g., U-shaped, V-shaped, square, etc.), as shown in the figure.

[0158] The pressure-compression tendon can be a longitudinally extending wire or segment. In any of these examples, the tendon can be located within multiple channels or sheaths (e.g., tubes 1, 2, 3, 4, etc.). Alternatively or additionally, in some examples, the pressure-compression tendon can be a longer wire segment that is commonly connected, bent, or looped. For example, Figure 12B The pressure-compression tendon shown is formed from a single wire having multiple pressure-compression tendon segments that bend from proximal to distal. Figure 12C Examples of multiple pressure-compression tendon segments are shown, formed from a single wire (monofilament or multifilament / braid) with a square shape from proximal to distal. Figures 12A-12G In the diagram, the patterns of the pressure-compression tendons are shown in a flat configuration; in use, these patterns can be wound around the circumference of the rigidification device, such as... Figure 12H As shown. In Figure 12H In this context, the rigid device includes a distal end region having multiple pressure-compression tendons (e.g., around the circumference of the device) Figures 12A-12D (Those shown). Compression tendons can be formed from a continuous ring of material (e.g., Figure 12B , Figure 12C and / or Figure 12E The free ends shown can be connected together. In use, the distal end of the device may also include a compression layer and one or more support layers (e.g., an inner flexible tube and / or an outer flexible tube), as described above. Therefore, the distal end region 1245 of the rigid device can be highly flexible (e.g., Figure 12I (as shown), but once rigidified, it becomes very stiff. The distal end region 1247 can also be rigidified.

[0159] As mentioned above, the ends of compression tendons can be free-floating, or they can be captured or contained. Compression tendons can be used solely for rigidification, or their function can be combined with steering functionality.

[0160] Figure 13A and Figure 13B An alternative example of a pressure-compression tendon is shown, arranged along a longitudinal segment of the rigid device, either at the distal end or along the entire segment (or most of the segment). Figure 13A An example is shown of a pressure-compression tendon segment 1321 configured as a wire. In some examples, such as... Figure 13B As shown, multiple short pressure-compression tendon segments are arranged longitudinally downwards along the length of the elongated body (other components of the rigidification device are omitted to show the arrangement of the pressure-compression tendons). In this example, multiple non-overlapping (although they may overlap in some cases) distinct pressure-compression tendon segments extend downwards along the longitudinal length around the circumference.

[0161] Figure 14A and Figure 14B Another example of a pressure-compression tendon is shown (in) Figure 14A (Seen in an enlarged view), the pressure-compression tendon is configured as a ring 1421 of wire (or other suitable material, including, for example, cable, fiber, metal, ceramic, plastic, elastomer). Multiple such rings 1421 can be arranged along the equipment section, such as... Figure 14B As shown. The loops in the wire can be configured to allow the device to flex (especially when the device is bent, the ends of the loops can extend freely to the distal and proximal sides), and may not have sharp free ends that could otherwise damage the device.

[0162] In some examples, the device can be configured to be pressurized to apply a radially outward force. For example, Figure 15A The device includes an outer support tube 1501 (shown as a coil reinforcement tube) and an inner support tube 1515 (also shown as a coil reinforcement tube), a compression layer 1507 (shown as a bladder), a rigidification layer 1509, and a pressure-compression tendon 1521. The rigidification layer 1509 comprises multiple strand segments intersecting each other vertically. In this arrangement, the tendon can be driven against the rigidification layer and against the outer support tube by stretching (e.g., applying positive pressure). In some examples, the device can be configured to use only the pressure-compression tendon 1521 for rigidification without utilizing the rigidification layer, such as... Figure 15C As shown. Alternatively, in some variations, the device may include a rigidification layer 1509, but a pressure-compression tendon may be wrapped around or passed through the rigidification layer, as shown. Figure 15D As shown. Element 1507 is shown as a complete reciprocating bladder, but the system can also be configured in which element 1507 is a single layer and another layer of the pressurization system is, for example, a sealing layer 1501 or 1515.

[0163] In some examples, the device can be configured to be pressurized to apply a radially inward force. Figure 15B Configured to apply a radially inward force to drive a pressure-compression tendon (and optionally as Figure 15B As shown, the rigidification layer 1509 abuts against the external support tube 1501 to rigidify the equipment.

[0164] In some examples, the device is configured to be pressurized to apply radially outward and radially inward forces, such as Figure 15E As shown. In this example, a pair of overlapping pressure-compression tendons 1521, 1521' are shown, with a compression layer 1507 between them.

[0165] Figures 15A-15E The compression layer 1507 shown in the example is configured to pressurize against the inner tube 1515 or the outer tube 1501.

[0166] Figures 16A-16FAn example of a device is shown, which includes a pressure-compression tendon at the distal end for enhancing the rigidity of the pressure-rigidification device in a rigid state without significantly reducing its flexibility in a flexible state. Figures 16A-16F The features shown can be used in any of these devices. Figure 16A In this design, the pressure-compression tendon can be formed as a U-shaped segment with a length of 1680 (although a continuous back-and-forth length can be used, as described above), and each segment includes a proximal end 1681 and a distal end 1682. In some examples, the pressure-compression tendon or a region of the pressure-compression tendon (e.g., the proximal end region of the pressure-compression tendon) can have a surface configured for easy gripping (uncoated cable / wire). The geometry of the pressure-compression tendon can be configured to maximize the surface area that can be gripped. In some cases, the proximal end region of the pressure-compression tendon can be flattened or widened (e.g., a bend or loop region) to enhance gripping. In any of these examples, the pressure-compression tendon can have a low-friction outer surface, such as a PTFE (e.g., ePTFE) coating, to reduce friction and allow the device to bend more easily. In some cases, the distal end of the pressure-compression tendon can be configured to have a low-friction outer surface.

[0167] As described above, in any of these devices, the tendon can be two or more times (e.g., 2 times) the length of the bending segment, such as greater than 20 cm. The pressure-compression tendon can be stiff enough to transmit axial force on the unconstrained segment without buckling. As described above, the pressure-compression tendon can be a cable (multifilament) and / or a monofilament wire.

[0168] As described above, in some cases, a sleeve or channel 1685 (e.g., guide, sheath, tube, etc.) may be included on each pressure-compression tendon and / or adjacent pressure-compression tendon pairs, such as Figure 16B and Figure 16C The enlarged details are shown in the figure. Therefore, in some cases, adjacent tendons can be joined together to share a sheath, as illustrated. The sleeve can be formed from any suitable material, such as, but not limited to, polyimide. The sleeve can be applied in any suitable manner. For example, it can be applied by sliding a tube (e.g., a polyimide tube) over the legs of two formed tendons. The sleeve can be as thin as possible while still being durable enough to hold the legs together, and can provide a smooth inner cavity that allows the legs to translate linearly and independently of each other while restricting radial movement.

[0169] When the sleeve bends, it can slide freely within the device. Typically, the sum of the distal and proximal unconstrained lengths of the compression tendon can be greater than the total maximum expected translation of any tendon due to bending. The compression tendons can be stiff enough to withstand buckling over that total unconstrained length. In any of these examples, one end of the sleeve can be attached to the compression tendon to lock its position.

[0170] Figure 16D An assembly comprising multiple pressure-compression tendons is shown, which, as described above, have been incorporated into sleeves on adjacent outriggers to form tubular layers of pressure-compression tendons. Figure 16D The diagram shows eight groups of tendons; for example, fewer tendons (e.g., between 3 and 8) can be used if stiffer tendons are used for translation over longer unconstrained distances. In some cases, more tendons (e.g., between 9 and 16 or more) can be used if the unconstrained distance is short and if highly flexible tendons are used. More tendons can significantly increase stiffness but may increase manufacturing complexity.

[0171] Figure 16E The connection between the free end of a pressure-compression tendon and an end cap (e.g., end or end region 1688) is shown. As described above, the end prevents injury from the potentially sharp ends of the tendon. In some cases, the end can constrain the distal end of the tendon to a predetermined radial (e.g., clockwise) position. In any of these devices, the end can be laser-cut or formed from a tube. The end can be a loop, as shown. The end can have a sinusoidal shape. Figure 16E In the diagram, two tendons in each group are shown as being laser-welded to the appropriate location at end 1688. The ends can be configured to maximize surface area and minimize circumferential stiffness, allowing them to revert to flexible ends. Alternatively, in some examples, the distal ends of the pressure-compression tendons can be crimped or ball-welded together and reverted to the composite structure of the device.

[0172] Figure 16F It shows including Figures 16A-16E An example of a portion of the distal end region of the rigidification device for the pressure-compression tendon and end cap 1688 shown. The proximal region includes a second rigidification layer 1609, and the distal region includes a pressure-compression tendon 1611. A compression layer 1623 is shown below the tendon and also below the second rigidification layer 1609. An external support layer, such as an external coil-wound tube, may be included in this example. The depressions can be created by periodically heating the molten film, wherein the area between the heat melts is a depression-like region in which the tendon can reside but remain movable.

[0173] Figures 17A-17BAnother example of a rigidification device is shown, which includes a set of pressure-compression tendons 1711 formed by single wires (or cables) arranged in a sinusoidal loop (e.g., Figure 17A As shown), the tendon includes a longitudinal arrangement (such as in any of these devices, having an angle of + / -10 degrees or less relative to the long axis, for example + / -9 degrees or less, + / -8 degrees or less, + / -7 degrees or less, + / -6 degrees or less, + / -5 degrees or less, + / -4 degrees or less, etc.). This example does not include an end cap, but may include one. The pressure-compression tendon may be exposed or may be within a sheath / sleeve as described above. Compression layer 1723 is shown below the pressure-compression tendon, but in some cases may be above it.

[0174] Figures 18A-18B Another example of a rigidification device comprising multiple pressure-compression tendon segments is shown. In this example, the pressure-compression tendon 1811 extends into a second rigidification layer 1809 (which may be formed of multiple intersecting filament segments, such as mesh, knitted fabric, woven fabric, etc.) and a compression layer (e.g., a pouch 1823). Figure 18A In this device, there are an inner support layer (e.g., an inner coil winding tube 1830) and an outer support layer (e.g., an outer coil winding tube 1831), the outer support layer of which has been partially removed. Figure 18B The rigidification device is shown with the outer support layer completely removed. In this example, the pressure-compression tendon segment is free-floating or can pass through within the second rigidification layer 1809 (e.g., which may be a woven fabric).

[0175] In any of these devices, the pressure-compression tendon can be held within an inner support layer and / or an outer support layer, and can be locked in place for rigidification when the compression layer is driven against the support layer (e.g., the outer support layer and / or the inner support layer). For example, Figures 19A-19B An apparatus including an outer support layer is shown, which is configured as an outer coil-wound tube, wherein a helical coil of material (not shown) (such as a wire of metal) is embedded within the layer to restrict or prevent the stretching / collapse of the support layer. Figure 19A In the middle, the outer support layer 1931 is made translucent, showing the pits or channels 1987 formed within the layer. Figure 19B The same area of ​​the opaque outer support layer is shown, along with an opening 1988 leading to the support layer, in which a pressure-compression tendon can be placed, allowing the pressure-compression tendon to slide in a flexible state but be compressed by the compression layer when pressure is applied to rigidify the device.

[0176] Figures 20A-20BAnother example of a support layer (e.g., an outer support layer, such as an outer coil-wound tube) is shown, configured to include recesses for a pressure-compression tendon. Typically, these channels or recesses can be formed in any suitable manner. In some cases, the channels for the pressure-compression tendon can be formed in the support layer as a multi-cavity extrusion. For example, channels can be formed using PTFE-coated wire (having an outer diameter larger than the pressure-compression tendon), which is included when the winding equipment is used to form the outer (or in some cases, inner) support layer. The support layer can then be reflowed onto / around the wire, and the wire can be removed, leaving the recesses. In some examples, a separate sheet, film, or coating can be attached to the inner diameter of the support layer at certain locations.

[0177] Figure 20A An example of a support layer is schematically shown, which is configured to include recesses 2087 for the aforementioned pressure-compression tendon (in Figure 20B (As shown in the cross-sectional view). In an example where the support layer is an outer support layer, a recess may be formed radially inside the coil winding support (e.g., wire). In an example where the support layer is an inner support layer, a recess may be formed radially outside the coil winding support. The distal end region includes an opening 2088 to receive a tendon. Figures 21A-21B An example of a rigidification device including a recess 2187 in an outer support layer 2131 that holds the tendon 2123 is shown at the distal end. The recess extends proximally over the region including a second rigidification layer 2109, and the same compression layer 2111 can be used to rigidify both the second compression layer and the tendon.

[0178] In any of these devices, the pressure-compression tendon can be configured as (or can be connected to) a torsion spring. This configuration allows adjustment of the proximal end of the pressure-compression tendon, making it easier to grip and / or less stiff when the device is rigidified. Figure 22A In the diagram, a portion of the pressure-compression tendon is shown configured as a torsion spring (e.g., the proximal end of the tendon may be configured as a torsion spring). Figure 22A and Figure 22B Two pressure-compression tendon segments are shown, configured to be wound into one or more loops 2224 at the proximal end to form a torsional spring. This allows the tendon to translate more easily and independently, thereby reducing bending stiffness when the device is in flexible mode. When the device is rigidified, this configuration also maximizes the surface area available for “gripping” the tendon pair, as the annular region can be compressed by the compression layer.

[0179] robotic devices The rigidification device described herein can be configured as part of a robotic system or used in conjunction with a robotic device. In some examples, the rigidification device can be configured as a robot-controlled outer tubular component, such as a robot-controlled sheath and / or endoscope assembly. Figure 11 An exemplary device 3100 is shown, comprising a rigidified device configured as an outer tube 3112; the system may optionally include an internal endoscope 3110. The outer tube and the internal endoscope may be controlled or manipulated by a robot individually or jointly (e.g., steering, moving, rotating, etc., including rigidification in some examples). In some versions, some elements may be robot-controlled, while others may be manually controlled. The outer tube and the internal endoscope may be configured as shown in any of the examples above and may have the same overall configuration or may have different configurations. Figure 11 As shown, the outer tube 3112 and the internal endoscope 3110 may terminate together in a common structure, such as a housing 3157 having an internal volume 3182 and one or more ports 3125y for connection to external components (e.g., water, suction, tools, etc.). The outer tube 3100 can be moved relative to the endoscope 3110 by rotation of an actuator mounted to the housing 3157. The system may include actuators 3171a and 3171b, which may be connected to cables 3163a and 3163b, respectively, to steer (e.g., bend or deflect) the ends of the endoscope 3110 (and / or the outer tube 3112). Other steering mechanisms (e.g., pneumatic, hydraulic, shape memory alloy, EAP (electroactive polymer), or motors) are also possible. The housing 3157 may also include bellows 3103a and 3103b, which can be connected to the pressure gaps of the endoscope 3110 and the outer sleeve 3112, respectively, to drive fluid through the pressure line 3105z. In variations for the endoscope and / or the outer sleeve, the bellows 3103a and 3103b are configured to stiffen upon application of pressure. As shown in this example, the housing 3157 may include eccentric cams 3174a and 3174b to control the bellows 3103a and 3103b. Alternatively, one or more linear actuators may be configured to actuate the bellows. As another alternative, the device can be stiffened and destiffened by one or more pumps or pressure sources (e.g., via the pressure line 3105z).

[0180] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety, to the extent that each individual publication or patent application is specifically and individually indicated to be incorporated by reference. Furthermore, it should be understood that all combinations of the foregoing concepts and other concepts discussed in more detail below (provided these concepts are not inconsistent with each other) are considered part of the inventive subject matter disclosed herein and can be used to achieve the benefits described herein.

[0181] Any method described herein (including a user interface) can be implemented as software, hardware, or firmware, and can be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, tablet, smartphone, etc.), which, when executed by the processor, causes the processor to control the execution of any steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, issuing reminders, etc. For example, any method described herein can be executed at least in part by a device including one or more processors having a memory storing a set of instructions for the procedures of the method.

[0182] Although various embodiments have been described and / or illustrated herein in the context of a full-featured computing system, one or more of these exemplary embodiments may be distributed as a program product in various forms, regardless of the specific type of computer-readable medium on which the distribution is actually performed. The embodiments disclosed herein may also be implemented using software modules that perform certain tasks. These software modules may include script files, batch files, or other executable files that may be stored on a computer-readable storage medium or within a computing system. In some embodiments, these software modules may configure a computing system to perform one or more of the exemplary embodiments disclosed herein.

[0183] As described herein, the computing devices and systems described and / or illustrated herein broadly refer to any type or form of computing device or system capable of executing computer-readable instructions, such as those contained in the modules described herein. In their most basic configuration, these computing devices may each include at least one memory device and at least one physical processor.

[0184] As used herein, the term "memory" or "memory device" generally refers to any type or form of volatile or non-volatile storage device or medium capable of storing data and / or computer-readable instructions. In one example, a memory device may store, load, and / or maintain one or more modules described herein. Examples of memory devices include, but are not limited to, random access memory (RAM), read-only memory (ROM), flash memory, hard disk drive (HDD), solid-state drive (SSD), optical disk drive, cache, variations or combinations thereof, or any other suitable memory for storage.

[0185] Furthermore, as used herein, the term "processor" or "physical processor" generally refers to any type or form of hardware implementation of a processing unit capable of interpreting and / or executing computer-readable instructions. In one example, a physical processor may access and / or modify one or more modules stored in the aforementioned memory devices. Examples of physical processors include, but are not limited to, microprocessors, microcontrollers, central processing units (CPUs), field-programmable gate arrays (FPGAs) implementing soft-core processors, application-specific integrated circuits (ASICs), portions of one or more of these, variations or combinations thereof, or any other suitable physical processor.

[0186] Although shown as separate elements, the method steps described and / or illustrated herein may represent parts of a single application. Furthermore, in some embodiments, one or more of these steps may represent or correspond to one or more software applications or programs that, when executed by a computing device, enable the computing device to perform one or more tasks, such as the method steps.

[0187] Furthermore, one or more devices described herein can transform data, physical devices, and / or representations of physical devices from one form to another. Additionally or alternatively, one or more modules described herein can transform a processor, volatile memory, non-volatile memory, and / or any other part of a physical computing device from one form of computing device to another by executing on a computing device, storing data on a computing device, and / or otherwise interacting with a computing device.

[0188] As used herein, the term "computer-readable medium" generally refers to any form of device, carrier, or medium capable of storing or carrying computer-readable instructions. Examples of computer-readable media include, but are not limited to, transport media such as carrier waves and non-transient media such as magnetic storage media (e.g., hard disk drives, magnetic tape drives, and floppy disks), optical storage media (e.g., optical discs (CDs), digital video disks (DVDs), and Blu-ray disks), electronic storage media (e.g., solid-state drives and flash memory media) and other distribution systems.

[0189] Those skilled in the art will recognize that any process or method disclosed herein can be modified in various ways. The process parameters and order of the steps described and / or illustrated herein are given by way of example only and can be varied as needed. For example, while the steps shown and / or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order shown or discussed.

[0190] The various exemplary methods described and / or illustrated herein may omit one or more steps described or illustrated herein, or include additional steps in addition to those disclosed. Furthermore, steps of any method disclosed herein may be combined with any one or more steps of any other method disclosed herein.

[0191] The processor described herein can be configured to perform one or more steps of any of the methods disclosed herein. Alternatively or in combination, the processor can be configured to combine one or more steps of one or more methods disclosed herein.

[0192] When a feature or element is described herein as "on another feature or element," it may be directly on the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is described as "directly on another feature or element," no intermediate features or elements are present. It should be understood that when a feature or element is described as "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or there may be intermediate features or elements present. Conversely, when a feature or element is described as "directly connected," "directly attached," or "directly coupled" to another feature or element, no intermediate features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements thus described or illustrated can be applied to other embodiments. Those skilled in the art will understand that a structure or feature referred to as "adjacent" to another feature may have portions overlapping with or below the adjacent feature.

[0193] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” as used herein are intended to equally include the plural forms. It should also be understood that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more related listed items and may be abbreviated as “ / .”

[0194] Spatial terms such as “under,” “below,” “lower,” “over,” and “upper” may be used herein to describe the relationship of one element or feature as shown in the accompanying drawings to one or more other elements or features. It should be understood that spatial terms are intended to encompass different orientations of the device in use or operation, in addition to those depicted in the accompanying drawings. For example, if the device in the accompanying drawings is reversed, an element described as “below” or “beneath” would then be oriented “over”. Thus, the exemplary term “below” can encompass both orientations above and below. The device may be otherwise oriented (rotated 90 degrees or otherwise), and the spatial terms used herein are interpreted accordingly. Similarly, unless otherwise specifically stated, terms such as “upwardly,” “downwardly,” “vertical,” and “horizontal” are used herein for illustrative purposes only.

[0195] While the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context otherwise requires. These terms may be used to distinguish one feature / element from another. Therefore, without departing from the teachings of the invention, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0196] Generally, any of the devices and methods described herein should be understood as inclusive, but all or a subset of the components and / or steps may optionally be exclusive and may be indicated as “composed of” or optionally “substantially composed of” various components, steps, subcomponents or substeps.

[0197] As used herein in the specification and claims, including in the examples, and unless otherwise expressly stated, all figures may be read as if they begin with the words “about” or “approximately,” even if the term is not explicitly stated. The phrase “about” or “approximately” may be used when describing magnitude and / or location to indicate that the described value and / or location is within a reasonably expected range of value and / or location. For example, numerical values ​​may have values ​​of + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context otherwise requires. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical ranges listed herein are intended to include all subranges contained therein. It should also be understood that, as those skilled in the art will properly understand, when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and this data represents the endpoints and starting points and ranges of any combination of data points. For example, if specific data point "10" and specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15, are considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0198] While various illustrative embodiments have been described above, any of several changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. Optional features of the various device and system embodiments may be included in some embodiments but not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0199] The examples and illustrations included herein are shown by way of illustration, not limitation, of specific embodiments in which the subject matter can be practiced. As mentioned, other embodiments can be utilized and derived therefrom, allowing for structural and logical substitutions and changes without departing from the scope of this disclosure. For convenience only, such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention," and if actually more than one is disclosed, it is not intended to actively limit the scope of this application to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any arrangement believed to achieve the same purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all modifications or variations of the various embodiments. After reading the above description, those skilled in the art will understand the combinations of the above embodiments and other embodiments not specifically described herein.

Claims

1. A rigidification device, comprising: An elongated body, the elongated body including a support layer; The near-side region of the elongated body has a rigidification layer, which includes multiple strands of lines that intersect each other. The distal region of the elongated body includes a plurality of pressure-compression tendon segments that extend proximally along the long axis of the elongated body. and A compression layer, configured to receive positive and / or negative pressure, to rigidify the elongated body by driving the rigidification layer against the support layer and by preventing or limiting axial movement of the plurality of pressure-compression tendon segments. The rigidification device is configured to switch between a flexible configuration and a rigid configuration.

2. The rigidification device according to claim 1, wherein, Multiple strands intersect each other vertically, crossing at a braiding angle greater than 5 degrees relative to the longitudinal axis of the flexible tube.

3. The rigidification device according to claim 1, wherein, The plurality of pressure-compression tendon segments extend proximally along the axis of the elongated body, approximately parallel to the length of the elongated body.

4. The rigidification device according to claim 1, wherein, The compression layer extends along both the proximal and distal regions.

5. The rigidification device according to claim 1, wherein, The compression layer includes a capsule layer.

6. The rigidification device according to claim 1, wherein, At least some of the pressure-compression tendons extend proximally to the proximal end of the rigidification device and are configured to steer the distal end of the elongated flexible internal support tube.

7. The rigidification device according to claim 1, wherein, The pressure-compression tendon segment is unattached at its proximal end.

8. The rigidification device according to claim 1, wherein, At least some of the pressure-compression tendon segments are connected to each other at their proximal ends.

9. The rigidification device according to claim 1, wherein, The plurality of pressure-compression tendon segments include a subset of tendons, the subset of tendons including a steering tendon that extends proximally to the proximal end of the rigidification device and is configured to steer the distal region of the elongated flexible internal support tube.

10. The rigidification device according to claim 1, wherein, The pressure-compression tendon segments are radially spaced from each other along the length of the elongated flexible internal support tube from the proximal to the distal side.

11. The rigidification device according to claim 1, wherein, The support layer includes an internal coil-wound tube.

12. The rigidification device according to claim 1, wherein, The support layer includes an outer coil-wound tube.

13. The rigidification device according to claim 1, wherein, The compression layer is configured to receive positive pressure to rigidify the elongated body.

14. The rigidification device according to claim 1, wherein, The compression layer is configured to receive negative pressure to rigidify the elongated body.

15. The rigidification device according to claim 1, wherein, Each of the pressure-compression tendon segments is held within a guide channel and / or tube extending along the long axis of the elongated body.

16. The rigidification device according to claim 1, wherein, The pressure-compression tendon segment is unattached at its proximal and distal ends.

17. The rigidification device according to claim 1, wherein, The pressure-compression tendon extends into the proximal region.

18. The rigidification device according to claim 1, wherein, The plurality of pressure-compression tendons includes 4 to 25 pressure-compression tendons.

19. The rigidification device according to claim 1, wherein, The plurality of pressure-compression tendon segments are formed from a single material ring.

20. The rigidification device according to claim 1, wherein, The plurality of pressure-compression tendon segments extend at least partially through the proximal region.

21. A method, the method comprising: In a flexible configuration, the rigidification device is turned, causing it to bend. The rigidification device includes an elongated body, multiple pressure-compression tendons, and a rigidification layer. The elongated body extends proximally to distally along a long axis. The multiple pressure-compression tendons extend longitudinally parallel to the long axis in the distal region of the elongated body. The rigidification layer extends in the proximal region of the elongated body, and the rigidification layer includes multiple intersecting filaments. Applying pressure causes the compression layer within the elongated body to prevent or limit axial movement of the pressure-compression tendon segments, and also prevents the multiple strand segments from sliding against each other, thereby transforming the rigidification device into a rigid configuration; and Release the pressure to transform the rigid device into the flexible configuration.

22. The method of claim 21, further comprising using one or more pressure-compression tendon segments to steer the distal end region to steer the distal end region.

23. The method according to claim 22, wherein, The steering involves replicating the shape of the elongated device within the inner cavity of the rigidification device.

24. The method of claim 21, further comprising inserting the device into an internal cavity of the patient's body.

25. The method according to claim 21, wherein, Applying pressure includes applying positive pressure.

26. The method according to claim 21, wherein, Applying pressure includes applying negative pressure.

27. A rigidification device, comprising: An elongated body extending along a long axis from the proximal side to the distal side; Multiple pressure-compression tendon segments extend along the long axis in the distal region of the elongated body, and the multiple pressure-compression tendon segments are configured to slide axially relative to the elongated body in a flexible configuration; A rigidification layer extends in the proximal region of the elongated body, the rigidification layer comprising a plurality of strand segments configured to slide against each other in a flexible configuration; and A compression layer configured to rigidify the first rigidification device by preventing axial slippage of the pressure-compression tendon and slippage of the plurality of strand segments relative to each other when pressure is applied to the compression layer.

28. The apparatus of claim 27, the apparatus being configured to form a nested system of rigidification devices, the apparatus further comprising a second rigidification device configured to be rigidified, wherein the second rigidification device is nested with the first rigidification device, and wherein the rigidification devices are configured to translate relative to each other and be rigidified to conduct shape along the nested system.

29. The apparatus according to claim 27, wherein, The rigidification layer extending on the elongated flexible tube in the proximal region comprises a plurality of filaments that intersect each other vertically and are configured to shear relative to each other in a flexible state.

30. The apparatus according to claim 27, wherein, At least some of the pressure-compression tendons extend proximally to the proximal end of the rigidification device and are configured to steer the distal end of the elongated flexible tube.

31. The apparatus according to claim 27, wherein, At least some of the pressure-compression tendon segments are unattached at their proximal ends, or form a loop connecting two of the pressure-compression tendon segments.

32. The apparatus according to claim 31, wherein, The plurality of pressure-compression tendon segments include a turning subset of tendons that extend proximally to the proximal end of the rigidification device and are configured to turn the distal end of the elongated flexible tube. Furthermore, the plurality of pressure-compression tendon segments include a non-turning subset of tendons that are not attached at their proximal ends or form a loop connecting two of the plurality of pressure-compression tendon segments.

33. The apparatus according to claim 27, wherein, The pressure-compression tendon segments are kept radially spaced along the length of the elongated flexible internal support tube from the proximal to the distal side.

34. The apparatus of claim 27 further includes an internal coil winding tube.

35. The apparatus according to claim 27, wherein, The compression layer includes a bladder configured to apply positive pressure.

36. The apparatus according to claim 27, wherein, The compression layer is configured to apply negative pressure against the elongated flexible tube to compress the plurality of pressure-compression tendon segments.

37. The apparatus according to claim 27, wherein, The pressure-compression tendon segment is located within a plurality of guides / tubes along its length, the guides / tubes being periodically provided with openings to expose the tendon.

38. The apparatus according to claim 27, wherein, The pressure-compression tendon segment has an end cap at its proximal end.

39. The apparatus according to claim 27, wherein, The pressure-compression tendon segment is fixed to the elongated flexible tube by a material with a Shore A hardness of 60A or less.

40. The apparatus according to claim 27, wherein, The plurality of pressure-compression tendons includes 4 to 24 pressure-compression tendons.

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