Laminated walls for rigidification devices

Abstract

A rigidification device includes an elongated flexible tube, a reinforcing layer located radially outside the elongated flexible tube, an outer layer located above the elongated flexible tube and the reinforcing layer, and a vacuum inlet or pressure inlet located between the elongated flexible tube and the outer layer, the vacuum inlet or pressure inlet being configured to attach to a vacuum source or pressure source. The elongated flexible tube includes a first reinforcing element and a second reinforcing element. The second reinforcing element is anti-wound relative to the first reinforcing element. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 002,202, filed March 30, 2020, entitled “COIL WOUND TUBES FOR RIGIDIZING DEVICES”, and U.S. Provisional Application No. 63 / 030,235, filed May 26, 2020, entitled “LAYEREDWALLS FOR RIGIDIZING DEVICES”, the entire contents of which are incorporated herein by reference.

[0003] This application may also relate to International Patent Application No. PCT / US2019 / 042650 entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”, filed on July 19, 2019, with publication number WO2020 / 018934, and / or to International Patent Application No. PCT / US2020 / 013937 entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES”, filed on January 16, 2020, the entire contents of which are incorporated herein by reference.

[0004] By invoking

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

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

[0007] Gastrointestinal loops occur when the endoscope cannot be advanced further due to excessive tortuosity or looping in the gastrointestinal tract, a well-known clinical challenge in endoscopy. In fact, one study found that 91 out of 100 patients undergoing colonoscopy experienced loops [Shah et al., “Magnetic Imaging of Colonoscopy: An Audit of Looping, Accuracy and Ancillary maneuvers.” Gastrointest Endosc 2000; 52:1-8]. Gastrointestinal loops prolong procedure time and can cause patient pain as they stretch blood vessel walls and the mesentery. Furthermore, gastrointestinal loops increase the incidence of gastrointestinal perforation. In cases of severe gastrointestinal loops, a complete colonoscopy is impossible because the loops stretch the length of the colon, preventing the colonoscope from reaching the tip. Gastrointestinal loops hinder precise control of the tip, preventing the user from achieving the desired one-to-one movement relationship between the handle and the endoscope tip. Such problems commonly occur during a wide range of endoscopic procedures, including colonoscopy, esophagogastric-duodenal endoscopy (EGD), enteroscopy, endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopy (including ESD (endoscopic submucosal dissection) and EMR (endoscopic mucosal resection)), robotic flexible endoscopy, transoral robotic surgery (TORS), anatomically modified cases (including Roux-en-Y), and NOTES (natural orifice endoscopic surgery). Therefore, a device is needed to help prevent gastrointestinal reflux, providing a more successful route into the gastrointestinal tract.

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

[0009] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a stiffening layer located radially outside the elongated flexible tube, an outer layer located above the elongated flexible tube and the stiffening layer, and a vacuum inlet or pressure inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The elongated flexible tube includes a first reinforcing element and a second reinforcing element. The second reinforcing element is wound in the opposite direction to the first reinforcing element. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0010] This embodiment and other embodiments of the invention may include one or more of the following features: The reinforcing layer may be a braided layer. The rigidification device may further include a bonding layer between the first reinforcing element and the second reinforcing element. The bonding layer may include an adhesive. The first and second reinforcing elements may be embedded in a matrix. The bonding layer may include the same material as the matrix. The first reinforcing element may be wound at an angle in a positive direction, and the second reinforcing element may be wound at the same angle in a negative direction. The first or second reinforcing element may be wound at an angle greater than 60 degrees and less than 90 degrees relative to the longitudinal axis of the rigidification device. The first reinforcing element may be located radially outside the second reinforcing element. The rigidification device may further include a separation layer between the first and second reinforcing elements. The first and second reinforcing elements may be woven together.

[0011] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a reinforcing layer located radially outside the elongated flexible tube, an outer layer located above the elongated flexible tube and the reinforcing layer, and a vacuum inlet or pressure inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The elongated flexible tube includes a first sub-layer and a second sub-layer. The first sub-layer includes a first reinforcing element that forms a first helix around a longitudinal axis of the rigidification device. The second sub-layer includes a second reinforcing element that forms a second helix around a longitudinal axis. The second helix is ​​located in the space between the first helices. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0012] This embodiment and other embodiments of the invention may include one or more of the following features: The reinforcing layer may be a braided layer. The rigidification device may further include a bonding layer between the first sublayer and the second sublayer. The bonding layer may include an adhesive. The first reinforcing element and the second reinforcing element may be embedded in the matrix. The bonding layer may include the same material as the matrix. The first reinforcing element may be wound in the same direction and at the same pitch as the second reinforcing element. The first reinforcing element and the second reinforcing element may each be wound at an angle greater than 60 degrees and less than 90 degrees relative to the longitudinal axis of the rigidification device. The second reinforcing element may radially overlap at least a portion of the first reinforcing element. The width of the second reinforcing element may be 1.5 to 4 times the width of the space between the first helices. The second reinforcing element may have a width smaller than that of the first reinforcing element.

[0013] Typically, in one embodiment, the rigidification device includes an elongated flexible tube, a reinforcing layer located radially outside the elongated flexible tube, an outer layer located above the elongated flexible tube and the reinforcing layer, and a vacuum inlet or pressure inlet located between the elongated flexible tube and the outer layer and configured to be attached to a vacuum source or pressure source. The elongated flexible tube includes a reinforcing element spiraled around the longitudinal axis of the device. Adjacent windings of the spiral radially overlap. The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

[0014] This embodiment and other embodiments of the invention may include one or more of the following features: The reinforcing layer may be a braided layer. The reinforcing element may be tilted at an angle. The width of the reinforcing element may be greater than the pitch of the helix. The reinforcing element may be embedded in the matrix. The reinforcing element may be wound at an angle greater than 60 degrees and less than 90 degrees relative to the longitudinal axis of the rigidification device. Attached Figure Description

[0015] The novel features of the invention are specifically mentioned in the claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and drawings, which illustrate exemplary embodiments utilizing the principles of the invention, in which:

[0016] Figure 1 A rigidification device is shown.

[0017] Figure 2 The reinforcing layer of the rigidification device is shown.

[0018] Figure 3 Another reinforcing layer of the rigidification device is shown.

[0019] Figures 4A to 4B A reinforcement layer with two reinforcing elements wound in opposite directions is shown.

[0020] Figure 5 A reinforcement layer is shown, consisting of stacked reinforcement elements that extend parallel to each other.

[0021] Figure 6 A reinforcing layer with reinforcing elements is shown, which are tilted so as to overlap during continuous winding.

[0022] Figure 7 A reinforcement layer with layered reinforcement elements is shown.

[0023] Figure 8 A reinforcing layer with an axially extending cover is shown.

[0024] Figure 9 A reinforcing layer is shown in which the reinforcing elements are alternately flat-wound and tilt-wound.

[0025] Figures 10A to 10F Different coil designs are shown for a layer in a rigidification device.

[0026] Figures 11A to 11B A wave-shaped reinforcing element is shown for use in a layer of a rigidification device.

[0027] Figures 12A to 12E The notch and dimple reinforcement elements used in a layer of a rigidification device are shown.

[0028] Figures 13A-13C A cut tube reinforcement element for a layer in a rigidification device is shown.

[0029] Figure 14 A reinforcement layer element with overlapping reinforcement elements is shown.

[0030] Figures 15A to 15C A torsion layer for use in rigidification devices is shown.

[0031] Figure 16 This is a cross-section of an exemplary reinforcement layer.

[0032] Figures 17A to 17B Rigidification devices with different rigidification shapes are shown.

[0033] Figures 18A to 18D An exemplary vacuum rigidification device is shown.

[0034] Figures 19A to 19B An exemplary pressure rigidification device is shown.

[0035] Figure 20 This is a graph showing the relationship between the bending strength and pressure of a rigidification device.

[0036] Figures 21A to 21E An exemplary woven fabric form is shown.

[0037] Figures 22A to 22B An exemplary woven fabric pattern is shown.

[0038] Figures 23A to 23C An exemplary woven fabric pattern is shown. Detailed Implementation

[0039] In general, the present invention describes a rigidification device (e.g., an outer sheath) configured to assist in the transport of endoscopes (e.g., endoscopes) or other medical instruments through curved or looped portions of the body (e.g., blood vessels). The rigidification device can be long, thin, and hollow, and can rapidly transform from a flexible configuration (i.e., a relaxed, soft, or loose configuration) to a rigid configuration (i.e., a rigid configuration and / or a configuration that retains its shape when rigidified). Multiple layers (e.g., coiled or reinforcing layers, sliding layers, braided layers, encapsulation layers, and / or sealing sheaths) can collectively form the walls of the rigidification device. The rigidification device can be transformed from a flexible configuration to a rigid configuration, for example, by applying a vacuum or pressure to its walls or interior. With the removal of the vacuum or pressure, these layers can readily shear or move against each other. Under the application of vacuum or pressure, these layers can transform into a state in which they exhibit significantly enhanced resistance to shearing, movement, bending, torsion, and buckling, thereby providing rigidity to the system.

[0040] The rigidification device described in this invention can provide rigidity for a variety of medical applications, including catheters, sheaths, endoscopes (e.g., endoscopes), wires, cannulas, trocars, or laparoscopic instruments. The rigidification device can be used as a standalone accessory or integrated into the body of the catheter, sheath, endoscope, wire, or laparoscopic instrument. The device described in this invention can also provide rigidity for non-medical structures.

[0041] Figure 1 An exemplary rigidification device system is illustrated. The system includes a rigidification device 300 having a wall having multiple layers, including a braided layer, an outer layer (a portion of which is cut away to reveal the underlying braided layer), and an inner layer. The system also includes a handle 342 having a vacuum inlet or pressure inlet 344 to provide vacuum or pressure to the rigidification device 300. An actuating element 346 can be used to turn the vacuum or pressure on and off, thereby allowing the rigidification device 300 to switch between a flexible configuration and a rigid configuration. The distal tip 339 of the rigidification device 300 can be smooth, flexible, and undamaged to facilitate distal movement of the rigidification device 300 through the body. Further, the tip 339 can taper from distal to proximal to further facilitate distal movement of the rigidification device 300 through the body.

[0042] The rigidification device of this invention may include an innermost layer configured to provide an inner surface against which additional layers (such as a braided layer) can be reinforced, for example, when a vacuum or pressure is applied within the wall of the rigidification device. This layer may further provide a seal for the wall (i.e., it may be leak-proof) and may be robust enough to provide resistance to radial collapse even during the rigidification process, during bending and / or compression of the rigidification device. Reference Figure 2 In some embodiments, the innermost layer 8815 may include a reinforcing sublayer 8840y, which includes reinforcing elements 8850z or coils within the matrix 8851z. The reinforcing elements 8850z may be continuous helical coils or closed loops with gaps between them (which exhibit greater resistance to collapse than helical coils). If constructed as helical coils, the reinforcing elements 8850z may be helical with a constant pitch or a varying pitch. Additionally, the inner layer 8815 may include an inner membrane 8852z and an outer membrane 8853z on one or both sides. In some embodiments, each of elements 8853z, 8852z, 8850z, and 8851z may have a thickness of 0.0002 to 0.015 inches, more narrowly, 0.0005 to 0.001 inches.

[0043] The reinforcing element 8850z can be, for example, a metal wire, such as a wire made of stainless steel, nitinol, or tungsten. The reinforcing element 8850z can also be, for example, a high-strength fiber (such as Kevlar, Dyneema, Vectran, Technora, or carbon fiber). The reinforcing element 8850z can be, for example, a support, a structure cut from a tube, or a braid. In some embodiments, the reinforcing element 8850z can be a round filament (e.g., with a diameter of 0.0005 to 0.030 inches, such as 0.001 inches, 0.003 inches, 0.005 inches, 0.007 inches, or 0.009 inches). In some embodiments, the reinforcing element 8850z may be a rectangular wire (e.g., having a width of 0.001 to 0.100 inches, such as 0.010 inches, 0.020 inches, 0.030 inches, 0.040 inches, 0.050 inches, 0.060 inches, 0.070 inches, 0.080 inches, 0.090 inches, or 0.100 inches, and / or having a thickness of 0.0003 to 0.020 inches, such as 0.001 inches, 0.003 inches, 0.005 inches, 0.007 inches, or 0.010 inches). In other embodiments, the reinforcing element 8850z may have an elliptical cross-section and / or may comprise multiple individual strands and / or may have a rectangular cross-section with rounded corners. In some embodiments, the reinforcing element 8850z may be cut from a single tube using, for example, a laser to create the gap. In some embodiments, no reinforcing element is used. In some embodiments, the reinforcing element 8850z may be textured (e.g., to improve adhesion and / or shear between adjacent layers). Textured elements may be provided, for example, by shot peening or sandblasting, abrasive wheels or wiping, or a textured wheel with an embossed pattern.

[0044] In some embodiments, the reinforcing element 8850z may be a element with a high aspect ratio (e.g., a high RE width relative to the RE height), such as an aspect ratio greater than 5:1, greater than 10:1, greater than 11:1, or approximately 12:1. It should be noted that in... Figure 2 In this context, RE width is the width of the reinforcing element 8850z, RE height is the height or thickness of the reinforcing element 8850z, and RE gap is the distance between the reinforcing elements 8850z. The aspect ratio of the height of the reinforcing element 8850z can advantageously help prevent external pressure caused by the parallelogram-shaped collapse of the reinforcing element 8850z within the innermost layer 8815. Parallelogram-shaped collapse occurs when the coil helix moves from approximately perpendicular to the coil's central axis to parallel to the coil's central axis (the helix essentially "flips"). Furthermore, it may be advantageous to prevent parallelogram-shaped collapse if the RE gap between the reinforcing elements 8850z does not exceed three times the RE height, for example, not more than twice the RE height, or for example, not more than 1.5 times the RE height. Additionally, a ratio of the inner diameter of the hollow tube having the innermost layer 8815 to the width of the reinforcing layer 8850z within the innermost layer 8815 to less than 5, for example, less than 4.5, or for example, approximately 4.3, also helps prevent parallelogram-shaped collapse.

[0045] The matrix 8851z can be a very low hardness, such as a TPU or TPE with a hardness equal to or less than 60A, 50A, 40A, 30A, 20A, or 10A. In some embodiments, the matrix 8851z can be TPU, TPE, PET, PEEK, polyester film (Mylar), polyurethane, or silicone. The inner and outer films 8852z and 8853z can similarly comprise TPU, TPE, PET, PEEK, polyester film (Mylar), polyurethane, or silicone. In some embodiments, the inner and outer films 8852z and 8853z can be applied by spraying, impregnation, wrapping into sheets or tubes, pulling through a solvent bath, melting, and / or solidification. In some embodiments, layer 8815 does not include the inner and / or outer films 8852z and 8853z, and / or may include an additional film. The inner and / or outer films 8852z and 8853z can produce smooth inner and outer surfaces.

[0046] In a specific example of the innermost layer 8815 used in the pressure system, this layer is fabricated as a hollow tube with an inner diameter of 0.260 inches, an RE width of 0.050 inches, an RE height of 0.008 inches, and an RE gap of 0.010 inches. Membranes 8853z are omitted on both sides. Membranes 8852z (on both sides of the matrix 8851z and the reinforcing element 8850z) are both made of polyurethane (100% strain corresponds to 600 psi pressure). The thickness of the matrix 8851z and each membrane 8852z is approximately 0.006 inches, for a total wall thickness of 0.018 inches. This structure can resist collapse under external pressures exceeding 10 atmospheres.

[0047] In a second specific example of the innermost layer 8815 used in a pressure system, membrane 8853z is omitted on both sides. The RE width is 0.050 inches, the RE height is 0.008 inches, and the RE gap is 0.010 inches. Membrane 8852z is a higher stiffness elastomer, such as an elastomer with a stress of 2000 psi at 100% strain, and a thickness of approximately 0.001 inches. The matrix 8851z can be 50A polyurethane. The matrix 8851z can be deposited as a thermoplastic elastomer cord stock, such as a rectangular cross-section of 0.008 inches or a circular cross-section of 0.010 inches. This cord stock can also be deposited with an increased axial modulus (but not transverse modulus) by co-extruding it with filaments (e.g., 0.001 inches in diameter) or fibers at its core.

[0048] In a third specific example of the innermost layer 8815 used in a pressure system, the reinforcing element 8850z can be a wire with a high aspect ratio. For example, in a rectangular stainless steel wire, layer 8815 can have a RE height of 0.005 inches, an RE width of 0.060 inches, and an RE gap of 0.006 inches. The tube with the innermost layer 8815 formed has an inner diameter of 0.26 inches. Elements 8852z and 8851z can be 80A polyurethane with a thickness of approximately 0.002 inches. Furthermore, layer 8851z can be 50A polyurethane (e.g., deposited from a heated vessel that includes molten polyurethane and orifices for precise distribution by pressure). This exemplary innermost layer 8815 structure can resist collapse under external pressures exceeding 10 atmospheres, such as pressures exceeding 12 atmospheres, or even pressures exceeding 13 atmospheres.

[0049] In a specific example of the innermost layer 8815 used in a vacuum system, the outer membrane 8853z on one side (e.g., the outer or top side) is omitted. The membrane 8852z above the reinforcement / matrix (outer side) comprises 0.005 inches of 50A polyurethane, the matrix 8851z is made of 0.005 inches of 50A polyurethane, the reinforcement element 8850z is stainless steel wire, the membrane 8852z below the reinforcement / matrix (inner side) comprises 0.0025 inches of 50A polyurethane, and the bottom outer membrane 8853z is 0.004 inches of 80A polyurethane. The RE width is 0.020 inches, the RE height is 0.005 inches, and the RE gap is 0.010 inches. The bottom outer membrane 8853z is a hydrophilic coating. The tube formed by layer 8815 has an inner diameter of 0.551 inches.

[0050] Although Figure 2 While the structures are presented symmetrically, it should be understood that the innermost layer 8815 does not need to have symmetrically arranged membranes 8852z and 8853z. For example, neither layer is at the bottom (inside the matrix / reinforcement), but both are at the top. Furthermore, it should be understood that the materials of the two innermost membranes 8852z do not need to be the same, nor do the materials of the two outermost membranes 8853z need to be the same.

[0051] Figure 3 Another exemplary innermost layer 315 is shown. Layer 315 is similar to layer 8815, except that it includes an additional reinforcing sublayer 341y, which includes one or more reinforcing elements 342y within a matrix 343y (i.e., in addition to sublayer 340y having reinforcing elements 350z and matrix 351z). Furthermore, a bonding sublayer 344y may be located between reinforcing sublayers 340y and 341y. Similar to innermost layer 8815, layer 315 may include an inner membrane 352z and an outer membrane 353z, respectively.

[0052] Reinforcing sublayer 341y may be the same as or different from reinforcing sublayer 340y. For example, reinforcing sublayer 341y may include the same material, size, and shape of reinforcing element and / or matrix as reinforcing sublayer 340y, or different material, size, and shape of reinforcing element and / or matrix than reinforcing sublayer 340y. In one specific example, one of reinforcing sublayers 340y and 341y may include a reinforcing element of a 0.005 inch × 0.030 inch flat stainless steel wire, while the other reinforcing sublayer may include a reinforcing element of a 0.002 inch × 0.020 inch flat stainless steel wire. In another specific embodiment, the reinforcing element of one of reinforcing sublayers 340y and 341y may include a circular cross-section, while the other reinforcing sublayer includes a reinforcing element with a flat cross-section (e.g., a flat wire with a width-to-thickness ratio between 10:1 and 200:1). As another example, reinforcing sublayers 340y and 341y may have the same or different thicknesses.

[0053] The bonding sublayer 344y may be made of, for example, the same or different matrix material and / or adhesive as that in the matrices 351z and 343y, and may advantageously prevent the reinforcing elements 350z and 342y from shearing relative to each other during bending of layer 315, thereby further helping to prevent collapse of layer 315. In some embodiments, the matrices 351z, 343y and / or the bonding sublayer 344y may be applied as a laminate or as a tube via bath, impregnation or spraying. In some embodiments, layer 315 may not include the bonding sublayer 344y.

[0054] In some embodiments, the substrates 351z, 343y and / or the bonding sublayer 344y may be applied via bath, impregnation, spraying or via a flat sheet element that is applied and then bonded by lamination. In some embodiments, the laminate (and / or the individual substrates 351z, 343y or bonding sublayer 344y) may be applied as a tube. In some embodiments, the tube may be applied by configuration (e.g., as an extruder). In other embodiments, the tube may be applied and then stretched downward on a mandrel under an applied axial load to produce a demonstrable change in its length (e.g., 2, 3, or 4 times the original length) and a corresponding reduction in wall thickness (e.g., 1 / 2, 1 / 3, or 1 / 4 of the original thickness, respectively).

[0055] The additional reinforcing sublayer 341y can be combined with the reinforcing sublayer 340y to advantageously help prevent the innermost layer 315 from collapsing (e.g., during the application of pressure to layer 315). In some embodiments, the additional sublayer 341y can also provide increased torsional resistance.

[0056] In one embodiment, the reinforcing sublayers (e.g., 340y, 341y) may include reinforcing elements that do not extend parallel to each other. For example, in Figures 4A to 4B An exemplary inner layer 415 is shown having two reinforcing sublayers 440y and 441y separated by a bonding sublayer 444y (additional components such as inner and outer membranes have been removed for clarity). Each reinforcing sublayer 440y and 441y may include one or more reinforcing elements 450z and 442y within a matrix 451z and 443y. In some embodiments, reinforcing elements 450z and 442y may have substantially the same width. Furthermore, reinforcing elements 450z and 442y may be wound in opposite directions relative to each other. That is, as shown... Figure 4BAs shown, the reinforcing element 450z of layer 440y can be helically wound relative to axis 448y, which is perpendicular to the longitudinal axis 435 of the rigidification device, at a negative angle α (e.g., a negative angle not exceeding 30 degrees, such as 0.5 to 25 degrees, or 2 to 15 degrees). Conversely, the reinforcing element 442y of reinforcing sublayer 441y can be helically wound relative to axis 448y at a positive angle β (e.g., a positive angle not exceeding 30 degrees, such as 0.5 to 25 degrees, or 2 to 15 degrees). The tendency of reinforcing element 450z to tilt in response to compression can be reduced by winding reinforcing element 442y around it at the opposite angle. An exemplary method of manufacturing layer 415 includes, for example, winding reinforcing element 450z from left to right; adding bonding sublayer 444y; and then winding reinforcing element 442y from right to left. In some embodiments, the anti-winding angle can be adjusted, for example, by including a multi-starting-point winding, as described below regarding Figures 10A to 10F As stated above.

[0057] In some embodiments, instead of having two separate reinforcing sublayers 440y and 441y, reinforcing elements 450z and 442y at opposite angles can be staggered (i.e., passing over each other vertically), for example in a woven fabric. In such embodiments, the bonding sublayer 44y can be omitted.

[0058] In some embodiments, the reinforcing sublayers (e.g., 340y, 341y) may include reinforcing elements that extend parallel to each other but overlap across the gaps between the reinforcing elements (i.e., across the matrix). For example, in Figure 5 An exemplary innermost layer 515 is shown, having two reinforcing sublayers 540y and 541y separated by a bonding sublayer 544y. Figure 5 As shown, layer 515 may therefore include an outer membrane 553z, an inner membrane 552z, and a layer having a reinforcing element 550z (and for clarity, from...). Figure 5 Sublayer 540y (removed from the matrix), binding sublayer 544y, and sublayer 542y with reinforcing element 542y (and also from the matrix for clarity) Figure 5The sublayer 541y (of the removed matrix) is a sublayer 541y. Reinforcing elements 542y may extend in the same direction and / or at the same angle or pitch as reinforcing elements 550z. Furthermore, reinforcing elements 542y of reinforcing sublayer 541y may be located on the gap (or matrix) between reinforcing elements 550z of reinforcing sublayer 540y. Additionally, reinforcing elements 542y may be positioned to overlap one or both of the reinforcing elements 550z below them. In some embodiments, the width of the outer reinforcing element 542y may be 1.5 to 4 times, for example 2 to 3 times, the width of the matrix or the spacing between reinforcing elements 550z (e.g., so as to span the entire gap even when the rigidification device bends). Partially overlapping the gap or matrix between reinforcing elements 542y and reinforcing elements 550z can advantageously help prevent the inner layer 515 from collapsing or penetrating at the matrix. Additionally, the second reinforcing sublayer 541y can help prevent the first sublayer 540y from tipping over during pressurization. In some embodiments, the outer reinforcing element 542y may be thinner or have a smaller width or diameter than the inner reinforcing element 550z, which can advantageously help maintain the integrity of the inner reinforcing element 550z under pressure. In some embodiments, the outer reinforcing element 542y may be plastic (e.g., PEEK), while the inner reinforcing element 550z may be metal.

[0059] Figure 6 Another exemplary innermost layer 615 is shown (layers such as inner and outer membranes have been removed for clarity). The innermost layer 615 may include a single reinforcing sublayer 640y comprising reinforcing elements 650z tilted at an angle such that the width w of the reinforcing elements 650z is greater than the pitch length. Adjacent windings of the reinforcing elements 650z can therefore overlap each other (see overlapping region 645y and non-overlapping region 646y). For example, the reinforcing element width w may be about 0.03 inches, the pitch may be about 0.02 inches, and there may be an overlap region 645y of about 0.003 inches to 0.005 inches. The overlapping reinforcing elements 650z can advantageously help prevent layer 615 from collapsing under pressure.

[0060] Figure 7 Another exemplary innermost layer 715 is shown. The reinforcing elements 750z of the reinforcing sublayer 740y can have a layered or stepped cross-sectional structure configured such that the inner portion of the first reinforcing element 750z overlaps with the outer stepped or layered portion of the adjacent reinforcing element 750z. Therefore, adjacent reinforcing elements 750z can overlap each other, which can advantageously help prevent layer 715 from collapsing under pressure. The reinforcing element 750z can be tapered, straight, circular, or wavy (i.e., have a cross-section with the aforementioned shapes).

[0061] Figure 14Another exemplary innermost layer 2415 is shown. The reinforcing elements 2450z of the reinforcing sublayer 2440y may have a tuning fork-like cross-sectional shape, having two (outer and inner) laterally / axially extending features. Adjacent reinforcing elements 2450z may fit between the laterally / axially extending features to overlap. Again, the overlapping reinforcing elements 2450z can advantageously help prevent layer 2415 from collapsing under pressure.

[0062] Figure 8 Another exemplary innermost layer 815 is shown. The reinforcing element 850z of layer 840y may include a cover 847y extending axially therefrom to cover the matrix 851z between the reinforcing elements 850z. The cover 847y may have a thickness less than the thickness of the reinforcing element 850z (e.g., in the radial direction) (e.g., the thickness of the cover 847y may be less than 50%, 40%, 30%, or 20% of the thickness of the reinforcing element 850z). Furthermore, as... Figure 8 As shown, the cover 847y may be stacked on and / or overlap with the outer surface of the reinforcing element 850z. In some embodiments, the cover 847y may be, for example, a thin metal or plastic attached to the reinforcing element 850z.

[0063] Figure 9 Another exemplary innermost layer 915 is shown. The reinforcing elements 950z of layer 940y can be arranged such that adjacent reinforcing elements 950z overlap each other. For example, one reinforcing element 950z can be flat (i.e., flattened along the periphery of the rigidification device), while adjacent reinforcing elements 950z can be angled (i.e., relative to the periphery of the rigidification device). Angled reinforcing elements 950z can extend from below the first flat reinforcing element 950z to above the top of the second flat reinforcing element 950z. Adjacent reinforcing elements 950z can be helicaled at substantially the same pitch. In some embodiments, adjacent reinforcing elements 950z can be joined together (e.g., adhered, welded, or otherwise connected).

[0064] The multiple sublayers and / or overlapping reinforcing elements described herein can be used to increase pressure resistance and / or torsional strength.

[0065] The innermost reinforcing element can have a variety of other configurations. For example... Figures 10D to 10F As shown, the reinforcing element 9205z can be a multi-starting-point coil winding (e.g., as shown in the image). Figure 10F The two starting points shown are as follows: Figure 10E The three starting points shown, or as... Figure 10D(As shown, there are 4 starting points). When using multi-start coil windings, the gap between reinforcing elements along the longitudinal axis can be the same as with a single coil, but the number of starting points can be 2, 3, 4, 5, 6, 7, 8, 9, or more. A single starting point produces a wire angle close to vertical (e.g., 2 degrees off vertical), while the multi-start approach produces a wire angle that biases the coil to tilt in one direction, further away from vertical (e.g., 4, 6, 10, 15, or even 20 degrees). This larger angle can be used to make the innermost layer less prone to tilting or structural collapse under pressure, as coils with larger pitch tend to support each other for stability. Figures 10A to 10C The individual starting points (coils) of the multi-start enhancement element 9205Z are shown. Figure 10C Showing Figure 10F One of the coils, Figure 10B Showing Figure 10E One of the coils, Figure 10A Showing Figure 10D One coil in the device. In some embodiments, multiple starting points can be used in multiple reinforcing sublayers to provide overlapping reinforcing elements. The number of multiple starting points can be adjusted to adjust the reinforcing angle relative to the central axis of the device. Furthermore, the multiple starting point element can be a solid monofilament or a multifilament element, such as strands and cables.

[0066] Any helical or coiled reinforcing element described herein may be replaced with other reinforcing elements (such as laser-cut tubes, discrete filament segments, injection-molded elements, housing elements, pivoted links, or links with flexures) or combined with said other reinforcing elements.

[0067] For example, in some embodiments, reference Figures 11A to 11B The reinforcing element 8950z can be a series of wavy or corrugated filaments (or wound corrugated filaments as described in this invention). Figure 11B As shown, when the device is loaded, the corrugated reinforcing element 8950z moves toward itself, compressing the matrix 8851Z between the filaments and resisting parallelogram-shaped collapse. In one specific embodiment, the innermost layer with such corrugated filaments may have an RE height of 0.005 inches, an RE width of 0.060 inches, and an RE gap of only 0.006 inches. The corrugated wave can vary by + / - 0.03 inches from the centerline (that is, the wave amplitude is 0.060 inches). The wave can repeat once every 0.3 inches (i.e., the wavelength is 0.3 inches).

[0068] In some embodiments, refer to Figures 12A to 12C The reinforcing element 9050z may include alternating pocket wires 9052z and notched wires 9053z. Upon unloading, the pockets and notches of each corresponding element can be separated (e.g., ...). Figure 12D (As shown). However, when loaded, the notch of wire 9053z moves towards colliding with the dimple of wire 9052z (as shown). Figure 12E As shown), the matrix 8851z between the compressed filaments resists parallelogram-shaped collapse.

[0069] In some embodiments, see Figures 13A to 13C The reinforcing element 9150z can be a flexure design, for example, laser-cut from a metal or plastic tube. In some embodiments, the flexure design can be configured to bend and / or expand and contract radially while resisting shortening. Figure 13C An exemplary flexural design for reinforcing element 9150z is shown, which allows radial expansion (e.g., for ease of assembly and manufacturability) and also provides radial hard stop under pressure (e.g., to prevent collapse).

[0070] In some cases, the reinforcing element can be separated from the inner layer. For example, the reinforcing element can be radially positioned inside or outside the inner layer. The innermost layer can have a hardness of, for example, 30A to 80A. Furthermore, the wall thickness of the innermost layer can be between 0.0005 and 0.060 inches. In some embodiments, the innermost layer may include a lubricant or coating (e.g., a hydrophilic coating) on ​​its inner surface to improve the slippage of endoscopes or other instruments passing through it. The coating can be hydrophilic (e.g.,...). coating or The coating can be either a coating material or a hydrophobic material (e.g., a fluoropolymer). The coating can be applied by methods such as dipping, coating, or spraying. The innermost layer can be a laminate with a low coefficient of friction.

[0071] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the matrix surrounding the reinforcing element may be composed of a material with high hydrolytic stability. That is, it is advantageous for the rigidification device described herein to maintain its structural integrity when exposed to immersion fluid environments (e.g., water, saline, gastric juice, or blood). If the matrix material is hygroscopic and thus absorbs fluid, the fluid can act as a plasticizer and soften the matrix, which may result in reduced resistance to pressure (or vacuum-based) structural collapse, thereby reducing the rigidity of the device. Therefore, in some embodiments, the matrix may be made of a hydrophobic material that absorbs little or no fluid and advantageously maintains its structural integrity even when immersed in a fluid. For example, the matrix may be made of polyethylene, polypropylene, polystyrene, thermoplastic elastomers (such as Chronoprene) TM and Teknor ApexMedallist TMIt can be made of styrene or polyvinyl chloride. As another example, the matrix can be made from a composite solution, such as styrene-ethylene-butene-styrene (SEBS), styrene-butadiene-styrene copolymer (SBS), or styrene block copolymer (SBC), for example... The SBC (Styrene-Based Component) comprises polystyrene blocks and rubber blocks, such as rubber blocks of polybutadiene or polyisoprene. In some embodiments, the matrix material may include additives that enhance adhesion, such as maleic anhydride.

[0072] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the reinforcing element and the matrix can be bonded together by an adhesive. For example, the reinforcing element can be applied thereto by impregnation, spraying, or immersion of an adhesive, and then the reinforcing element can be located within the matrix to bond the matrix and the reinforcing element. In some embodiments, the reinforcing element and the matrix can have a final bond strength of up to 50 pounds per square inch. The adhesive can be, for example, Chemlok. TM Adhesives. By using adhesives to adhere the reinforcing elements to the substrate, the reinforcing layer can remain intact to resist pressure and / or vacuum collapse.

[0073] For any reinforcing layer described herein (e.g., the innermost layer 8815), the reinforcing layer may be manufactured such that it has a final diameter (i.e., within the rigidification device) equal to or close to its net (i.e., manufactured) diameter, thereby ensuring that the matrix does not need to hold the reinforcing element to a specific diameter. For example, the final diameter of the reinforcing layer may be within 10% of the net diameter, such as within 5% of the net diameter, or even within 2% of the net diameter. A final diameter close to the net diameter advantageously ensures reduced internal stress in the reinforcing layer, thereby reducing creep and / or failure of the reinforcing layer. In some embodiments, the reinforcing element may be manufactured, for example, by yielding the reinforcing element when it is applied to the matrix, such as by passing the reinforcing element through a series of deformation rollers.

[0074] Any layer described herein may include multiple reinforcing sublayers stacked with its adjacent layers (e.g., similar to sublayers 340y, 341y). For example, the innermost layer may include sublayers thereon (e.g., instead of those embedded therein). Sublayers may include one or more strips or filaments spirally wound at an angle (e.g., at an angle less than 90 degrees, for example greater than 60 degrees and less than 90 degrees, for example 65 degrees to 89.5 degrees, for example 75 degrees to 88 degrees, relative to the longitudinal axis of the rigidification device). For example, as Figures 15A to 15CAs shown, the innermost layer 8715 may have a first sublayer 8702a wound thereon in a first direction and a second sublayer 8702b wound thereon in the opposite second direction (e.g., the first sublayer 8702a may be wound at 70 degrees relative to a longitudinal or horizontal axis, and the second sublayer 8702b may be wound at -70 degrees). Adding layers 8702a and 8702b can increase the torsional resistance of the finished device. In some embodiments (e.g., in embodiments where increased flexibility is desired), the two sublayers 8702a, 8702b may shear or slide relative to each other. For example, a sliding layer may be present between the two layers 8702a, 8702b. In some embodiments, a sliding layer may be present between the two sublayers and / or between other layers of the device (e.g., the innermost layer). In some embodiments, the additional sublayers 8702a, 8702b may be part of another layer (e.g., a braided layer) or interwoven with another layer. In embodiments where increased torsional stiffness is required, the sublayer may be made of a material that can withstand both high tensile and high compressive loads (e.g., sheet metal or filament), or of a material that can withstand high tensile loads but only low compressive loads (e.g., multiple small-diameter filaments or fibers).

[0075] Any reinforcing layer described herein (e.g., the innermost layer 8815) may be constructed to include materials of alternating types along the longitudinal axis of the device. For example, refer to Figure 16 Layer 18815 may include alternating portions 18807y and 18806y, respectively composed of a high-hardness material and a low-hardness material. Furthermore, the high-hardness material portion 18807y may include an embedded reinforcing element 18850z. In some embodiments, the alternating portions 18807y and 18806y may be formed by a helical portion 18807y, but with a gap between the helical portions, which is subsequently filled by the lower-hardness material of portion 18806y. This design advantageously allows layer 18815 to have high stiffness at portion 18807y while maintaining flexibility and bendability at the hinge point created by portion 18806y. Therefore, a device including layer 18815 can have high stiffness and resistance to pressure / vacuum collapse while still maintaining high baseline flexibility.

[0076] refer to Figures 21A to 21E The woven fabric of any rigidification device described in this invention can have a variety of different weave patterns. For example, see reference... Figure 21A The weave of layer 1709 can be a full diamond pattern, in which two adjacent strands 1733a and b extend first above the two strands and then below them. (See reference...) Figure 21BThe weave of layer 1709 can be a full-coverage pattern, wherein each strand 1733a extends above and below the two strands in the opposite manner to its adjacent strand 1733b. (See reference...) Figure 21C The weave of layer 1709 can be a diamond half-width pattern, wherein each strand 1733a extends above and below another strand, opposite to the adjacent strand 1733b. (See reference) Figure 21D and Figure 21E The weave of layer 1709 may include one or more longitudinal strands 1733c passing through cross strands 1733a, 1733b. The longitudinal strands 1733c may be discontinuous (e.g., ...). Figure 21D (as shown) or continuous (such as) Figure 21E (As shown). Furthermore, in some embodiments and as shown... Figure 21E As shown, the longitudinal strand 1733c may pass above the first strand joint 1740a of the braided strands 1733a and 1733b and below the second joint 1740b of the braided strands 1733a and 1733b. In some embodiments, the upper joint 1740a and the lower joint 1740b may be adjacent to each other. In other embodiments, there may be 2 to 50 upper joints 1740a and lower joints 1740b, for example, 2, 3, 4, 10, 20, or 40 joints that are far apart from each other.

[0077] The strands of any braided layer described herein may be rectangular / flat (e.g., with a long side of 0.001 to 0.060 inches, such as 0.005 inches, 0.007 inches, 0.010 inches, or 0.012 inches, and a short side of 0.0003 to 0.030 inches, such as 0.001 inches, 0.002 inches, or 0.003 inches), round (e.g., with a diameter of 0.001 to 0.020 inches, such as 0.005 inches, 0.01 inches, or 0.012 inches), or elliptical. In some embodiments, some strands 233 may be flat, and some strands 233 may be round.

[0078] refer to Figures 22A to 22B Each share of wire 1833 can include a single filament 1818 ( Figure 22A ) or multiple fine filaments 1818a-c (in Figure 22B In the diagram, three filaments 1818a-c are shown in each strand 1833. The filaments 1818 can be selected (i.e., their diameter, spacing, and modulus can be specifically customized) to reduce crimp (wavy or bent filaments). Reduced crimp helps the system provide enhanced compressive and torsional drag, which translates into increased system stiffness. Reference Figures 23A to 23CEach strand 2333 may include multiple filaments 2318 bundled together (i.e., twisted, wound, or braided). For example, there may be 2 to 20 filaments 2318, such as 5 to 10 filaments 2318, such as 7 filaments (e.g. Figures 23A to 23C (as shown). In some embodiments, the diameter of each filament 2318 may be from 0.0005 inches to 0.010 inches, such as from 0.001 inches to 0.05 inches, such as about 0.002 inches.

[0079] In some embodiments, the strands or filaments may be metallic (e.g., stainless steel, aluminum, nitinol, tungsten, or titanium), plastic (nylon, polyethylene terephthalate, PEEK, polyetherimide), or high-strength fibers (e.g., aromatic polyamide, ultra-high molecular weight polyethylene, or liquid crystal polymers (e.g., Vectran)). In some embodiments, the strands may comprise filaments made of two or more different materials (e.g., some filaments in the strands may be nitinol and some may be stainless steel). In some embodiments, the strands or filaments may be made of multilayer composite materials, such as a metal core with a thin elastomer, plastic, hard epoxy, or enamel coating. In some embodiments, coating the strands or filaments with a hard material such as hard epoxy or enamel can help prevent yielding of the strands or filaments during use of the rigidification device. In one specific example, the strands may include round nylon (or metal filaments with a diameter of 0.010 inches) wound together with flat, aluminized PET with a cross-sectional dimension of 0.002 inches × 0.002 inches.

[0080] In some embodiments, the strands of the braid can be made of a material with a known high coefficient of friction. For example, the strands can be a monolithic structure or have a coating, such that the strands include an aluminum coating on an aluminum core, a copper coating on a copper core, a silver coating on a silver core, or a gold coating on a gold core. As another example, the strands can be coated with an elastic material (e.g., a lower-hardness elastomer can be coated on top of a higher-modulus substrate). As yet another example, the strands can be made of styrene copolymers, polycarbonate, or acrylic acid.

[0081] The braided layer may contain 12-800 strands, for example 24, 48, 96, 120, 144, or more strands. In some embodiments, there are 96 or more strands, 120 or more strands, 200 or more strands, or 240 or more strands. The increased interaction between the strands advantageously contributes to the rigidity of the braid.

[0082] In some embodiments, the braided layer may be integrated with or embedded in the matrix of any reinforcing layer (e.g., the innermost layer 8815).

[0083] Figure 17A and Figure 17B An exemplary rigidification device in a rigidification configuration is shown. When the rigidification device is rigidified, it is rigidified in the shape it was in before the application of vacuum or pressure; that is, it does not straighten, bend, or otherwise significantly change its shape (e.g., it can be in the shape of...). Figure 17A The ring configuration shown or as Figure 17B The serpentine shape shown becomes stiff. This may be because the air hardening effect on the inner or outer layer (e.g., made of a winding tube) may only be a small percentage (e.g., 5%) of the stiffening device's maximum load capacity when bent, thus allowing the stiffening device to resist straightening. Once the vacuum or pressure is released, the braid or strands can unlock relative to each other and move again, thus allowing the stiffening device to bend. Furthermore, as the stiffening device becomes more flexible by releasing the vacuum or pressure, it retains the shape it was in before the vacuum or pressure was released to become flexible; that is, it does not straighten, bend, or otherwise significantly change its shape. Therefore, the stiffening device described in this invention can be transformed from a flexible, less stiff configuration to a more stiff rigid configuration by restricting the movement between the strands of the braid (e.g., by applying a vacuum or pressure).

[0084] The rigidification devices described in this invention can rapidly switch between rigid and flexible configurations, and in some embodiments have an unlimited number of switching cycles. As interventional medical devices are manufactured to be longer and inserted deeper into the human body, and as they are expected to be used for more demanding surgical procedures, the demand for precision and control increases. Selective rigidification devices (e.g., sheaths) as described in this invention can advantageously provide both the benefits of flexibility (when needed) and the benefits of rigidity (when needed). Furthermore, the rigidification devices described in this invention can be used, for example, in classic endoscopes, colonoscopes, robotic systems, and / or guidance systems, such as those described in International Patent Application PCT / US2016 / 050290, filed September 2, 2016, entitled “DEVICE FOR ENDOSCOPICANDANCEMNT THROUGH THE SMALL INTESTINE,” the entire contents of which are incorporated herein by reference.

[0085] The rigidification device described in this invention may additionally or alternatively include international patent application No. PCT / US2016 / 050290, filed September 2, 2016, entitled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALLINTESTINE”, published as WO2017 / 041052; international patent application No. PCT / US2018 / 042946, filed July 19, 2018, entitled “DYNAMICALLY RIGIDIZING OVERTUBE”, published as WO2019 / 018682; and international patent application No. PCT / US2018 / 042946, filed July 19, 2019, entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL”, published as WO2020 / 018934. Any features described in International Patent Application No. PCT / US2019 / 042650 entitled “STRUCTURES” and International Patent Application No. PCT / US2020 / 013937 entitled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICALSTRUCTURES” filed on January 16, 2020, are incorporated herein by reference in their entirety.

[0086] The rigidification device described in this invention can be provided in various configurations, including different lengths and diameters. In some embodiments, the rigidification device may include a working channel (e.g., for typical endoscopic tools to pass through within the body of the rigidification device), an air bladder, a nesting element, and / or a lateral loading feature.

[0087] refer to Figures 18A to 18D In one embodiment, the tubular rigidification device 100 may include walls having multiple layers (e.g., for instruments or endoscopes to be placed through) surrounding a lumen 120. A vacuum may be provided between the layers to rigidify the rigidification device 100.

[0088] The innermost layer 115 may be configured to provide an inner surface, for example, so that the remaining layers can be reinforced against the inner surface when a vacuum is applied within the wall of the rigidification device 100. This structure can be configured to minimize bending forces / maximize flexibility under non-vacuum conditions. In some embodiments, as described above, the innermost layer 115 may include reinforcing elements 150z or coils within the matrix.

[0089] The layer 113 above the innermost layer 115 (i.e. radially outward) can be a sliding layer.

[0090] Layer 111 can be a radial gap (i.e., a space). The gap layer 111 can provide space for the braided layer thereon to move within it (when no vacuum is applied), and provide space for the braided or woven layer to move radially inward within it (when a vacuum is applied).

[0091] Layer 109 may be a first braided layer comprising braided strands 133, similar to those described elsewhere in this invention. The braided layer may be, for example, 0.001 inches to 0.040 inches thick. For example, the braided layer may be 0.001 inches, 0.003 inches, 0.005 inches, 0.010 inches, 0.015 inches, 0.020 inches, 0.025 inches, or 0.030 inches thick.

[0092] In some embodiments, such as Figure 18B As shown, the braid can have stretched or loop fibers 137. The loop fibers 137 can be spirally and / or woven into the braided layers. Furthermore, the loop fibers 137 can be positioned at 2 to 50 loops per inch, for example, 20 to 40 loops per inch. The loop fibers 137 can advantageously transmit high compressive stiffness in the radial direction (to resist torsion or outward bending), but can remain compliant in the direction of the longitudinal axis 135 of the rigidification device 100. That is, if compression is applied to the rigidification device 100, the braided layer 109 will attempt to expand its diameter upon compression. The loop fibers 137 can resist this radial expansion, thereby resisting compression. Therefore, the loop fibers 137 can provide a system that is flexible when bent, but still resistant to stretching and compression.

[0093] Layer 107 can be another radially spaced layer similar to layer 111.

[0094] In some embodiments, the rigidification device of the present invention may have more than one braided layer. For example, the rigidification device may include two, three, or four braided layers. (See reference...) Figure 18CLayer 105 may be a second braided layer 105. The second braided layer 105 may have any of the characteristics described with respect to the first braided layer 109. In some embodiments, the fabric of the second braided layer 105 may be the same as the fabric of the first braided layer 109. In other embodiments, the fabric of the second braided layer 105 may differ from the fabric of the first braided layer 109. For example, the fabric of the second braided layer 105 may include fewer strands and a larger braid angle α than the fabric of the first braided layer 109. Having fewer strands can help increase the flexibility of the rigidification device 100 (in the case of having an equal or greater number of strands relative to the second braided layer), and a larger braid angle α can help reduce the diameter of the first braided layer 109 (e.g., if the first braided layer is compressed) while increasing / maintaining the flexibility of the rigidification device 100. As another example, the fabric of the second braided layer 105 may include more strands and have a larger braid angle α compared to the fabric of the first braided layer 109. Having more strands can produce a relatively strong and smooth layer, while having a larger braid angle α can help to reduce the diameter of the first braid layer 109.

[0095] Layer 103 may be another radially spaced layer similar to layer 111. Spaced layer 103 may have a thickness of 0.0002 inches to 0.04 inches, for example, about 0.03 inches. Thickness within this range ensures that the strands 133 of the braided layer can easily slide and / or bulge relative to each other to ensure flexibility of the rigidification device 100 during bending.

[0096] The outermost layer 101 can be configured such that when a vacuum is applied to pull it toward the braided layers 105, 109, the outermost layer 101 moves radially inward and conforms to the surface of the braided layer. The outermost layer 101 can be flexible and undamaged, and can be sealed at both ends to form a vacuum-sealed chamber with layer 115. The outermost layer 101 can be elastic, for example, made of polyurethane. The hardness of the outermost layer 101 can be, for example, 30A to 80A. Furthermore, the outermost layer 101 can have a thickness of 0.0001 inches to 0.01 inches, for example, approximately 0.001 inches, 0.002 inches, 0.003 inches, or 0.004 inches. Alternatively, the outermost layer can be a plastic, including, for example, LDPE, nylon, or PEEK.

[0097] In some embodiments, the outermost layer 101 may have, for example, tensile or circumferential fibers 137 extending therethrough. The circumferential fibers 137 may be made of, for example, aramids (e.g., Technora, nylon, Kelvar), polyarylate fibers, polyethylene fibers, carbon fibers, glass fibers, or plastics. Furthermore, the circumferential fibers 137 may be configured with 2-50 loops per inch, for example, 20 to 40 loops per inch. In some embodiments, the circumferential fibers 137 may be laminated within an elastic sheath. The circumferential fibers can advantageously provide higher stiffness in one direction compared to the other (e.g., they can be very stiff in the circumferential direction but very compliant in the longitudinal axis direction of the rigidification device). Additionally, the circumferential fibers can advantageously provide low circumferential stiffness until the fibers are placed under tensile loads, at which point the circumferential fibers can suddenly exhibit high circumferential stiffness.

[0098] In some embodiments, the outermost layer 101 may include a lubricant, coating, and / or powder (e.g., talc) on its outer surface to improve the sliding of the rigidification device within the anatomical structure. The coating may be hydrophilic (e.g., ...). coating or Coatings can be applied by impregnation, coating, or spraying, for example, by a coating material that is hydrophobic (e.g., a fluoropolymer).

[0099] The innermost layer 115 may similarly include a lubricant, coating (e.g., a hydrophilic or hydrophobic coating) and / or powder (e.g., talc) on its inner surface, which is configured to allow for easier shearing between adjacent layers, especially when no vacuum is applied to the rigidification device 100, in order to maximize flexibility.

[0100] In some embodiments, the outermost layer 101 can be relaxed on the radially inward layers. For example, there can be a 0-inch to 0.200-inch diameter gap between the inner diameter of layer 101 (assuming it forms a tube) and the radially inward next layer (e.g., with a braided layer). This can make the vacuum-rigidified system more flexible when not under vacuum, while still maintaining a high rigidity factor. In other embodiments, the outermost layer 101 can be stretched somewhat on the radially inward next layer (e.g., a braided layer). For example, the zero-strain diameter of the tube forming layer 101 can be 0-inch to 0.200 inches smaller than the diameter of the radially inward next layer and stretched thereon. When not under vacuum, the system can have less flexibility than a system with a more relaxed outer layer 101. However, it can also have a smoother appearance and is less likely to tear during use.

[0101] In some embodiments, the outermost layer 101 may be relaxed on the radially inward layers. A small positive pressure may be applied under layer 101 to gently expand it and allow the stiffening device to bend more freely in a flexible configuration. In this embodiment, the outermost layer 101 may be elastic and may retain compressive force on the fabric, thus giving it stiffness. Once a positive pressure (sufficient to nominally unwind the sheath from the fabric, e.g., 2 psi) is provided, the outermost layer 101 no longer contributes stiffness, which can enhance the baseline flexibility. When stiffening is required, a negative pressure (vacuum) may be used instead of a positive pressure to provide stiffness.

[0102] Vacuum can be supplied within the rigidification device 100 in the range of minimum vacuum to full atmospheric vacuum (e.g., approximately 14.7 psi). In some embodiments, a vent valve, regulator, or pump controller may be provided to allow the vacuum to be released to any intermediate level to provide variable stiffness capability. Vacuum pressure can advantageously rigidify the rigidification device structure by pressing braided sleeve layers against adjacent layers. The braid is naturally flexible when bent (i.e., when bent perpendicular to its longitudinal axis), and when the sleeve bends, the mesh structure formed by the interlaced strands deforms so that the braid conforms to the shape of the bend when placed on the inner layer. This causes the angle of each mesh element in the geometry of the mesh to change as the braided sleeve bends. When compressed between conformal materials (e.g., layers described herein), the mesh elements are locked at their current angles and have enhanced resistance to deformation when a vacuum is applied, thereby enabling the entire structure to be rigidified in bending when a vacuum is applied. Furthermore, in some embodiments, circumferential fibers passing through or on the fabric can bear tensile loads, which helps prevent localized twisting of the fabric when subjected to high bending loads.

[0103] When transitioning from a flexible to a rigid configuration, the stiffness of the rigidification device 100 can increase from a factor of 2 to over 30, for example, by 10, 15, or 20. In a specific example, the stiffness of a rigidification device similar to rigidification device 100 was tested. The tested rigidification device had a wall thickness of 1.0 mm and an outer diameter of 17 mm. A force was applied to the end of a 9.5 cm long cantilever section of the rigidification device until it deflected by 10 degrees. This required only 30 grams of force in flexible mode, while in rigid (vacuum) mode, it required 350 grams.

[0104] In some embodiments of the vacuum rigidification device 100, there may be only one braided layer. In other embodiments of the vacuum rigidification device 100, there may be two, three, or more braided layers. In some embodiments, one or more radial gap layers or sliding layers of the rigidification device 100 may be removed. In some embodiments, some or all of the sliding layers of the rigidification device 100 may be removed.

[0105] The braided layer described in this invention can serve as a variable stiffness layer. The variable stiffness layer may include one or more variable stiffness elements or structures that, when activated (e.g., when a vacuum is applied), increase bending stiffness and / or shear resistance, resulting in higher stiffness. Other variable stiffness elements may be used in addition to or in place of the braided layer. In some embodiments, a coupling may be used as a variable stiffness element, as described in International Patent Application PCT / US2018 / 042946, filed July 19, 2018, entitled “DYNAMICALLYRIGIDIZING OVERTUBE,” the entire contents of which are incorporated herein by reference. Optionally or additionally, the variable stiffness element may include particles or granules, plugging layers, sheets, rigidifying axial members, rigidifiers, longitudinal members, or basic longitudinal members.

[0106] In some embodiments, the rigidification device of the present invention can be rigidified by applying pressure instead of applying a vacuum. For example, see reference... Figures 19A to 19B The rigidification device 2100 may be similar to the rigidification device 100, except that it may be configured to maintain a pressure (e.g., greater than 1 atmosphere) for rigidification instead of a vacuum. Therefore, the rigidification device 2100 may include multiple layers (e.g., for placing instruments or endoscopes through it) surrounding the cavity 2120. The rigidification device 2100 may include an innermost layer 2115 (similar to the innermost layer 115), a sliding layer 2113 (similar to the sliding layer 113), a pressure gap 2112, a bladder layer 2121, a gap layer 2111 (similar to the gap layer 111), a braided layer 2109 (similar to the braided layer 109) or other variable stiffness layers as described in this invention, a gap layer 2107 (similar to layer 107), and an outermost receiving layer 2101.

[0107] The pressure gap 2112 may be a sealed chamber that provides clearance for applying pressure to the layers of the rigidification device 2100. Pressure may be supplied to the pressure gap 2112 using a fluid or gaseous inflation / pressure medium. The inflation / pressure medium may be water or saline solution, or, for example, a lubricating fluid such as oil or glycerin. The lubricating fluid may, for example, help the layers of the rigidification device 2100 flow to each other in a flexible configuration. During rigidification of the rigidification device 2100, the inflation / pressure medium may be supplied to the gap 2112 and may be partially or completely drained from the gap 2112 to convert the rigidification device 2100 back to a flexible configuration. In some embodiments, the pressure gap 2112 of the rigidification device 2100 may be connected to a pre-filled pressure source, such as a pre-filled syringe or pre-filled insulator, thereby reducing the setup time required by the physician.

[0108] The capsule 2121 may be made of, for example, a low-hardness elastomer (such as Shore 20A to 70A) or a thin plastic sheet. The capsule 2121 may be formed from a plastic or rubber sheet that has been longitudinally sealed to form a tube. For example, the longitudinal seal may use a butt joint or an overlap joint. For example, an overlap joint may be formed longitudinally in a rubber sheet by melting rubber at the overlap joint or by using an adhesive. In some embodiments, the thickness of the capsule 2121 may be from 0.0002 inches to 0.020 inches, for example, approximately 0.005 inches thick. The capsule 2121 may be soft, high-friction, elastic, and / or wrinkle-prone. In some embodiments, the capsule 2121 is a polyolefin or polyester. The capsule 2121 may be formed, for example, by using methods for forming heat-shrinkable tubes, such as extruding a base material and then thinning the walls using heat, pressure, and / or radiation. When pressure is applied through pressure gap 2112, the bladder layer 2121 can expand through gap layer 2111 to push braid layer 2109 toward outermost receiving layer 2101, thereby reducing the relative movement of braided strands.

[0109] The outermost receiving layer 2101 may be a tube, such as an extruded tube. Optionally, the outermost receiving layer 2101 may be a tube in which reinforcing members (e.g., wires, including wires with circular or rectangular cross-sections) are encapsulated in an elastic matrix, similar to the innermost layer described in other embodiments of the invention. In some embodiments, the outermost receiving layer 2101 may include a helical spring (e.g., made of round or flat filaments), and / or a tubular braid (e.g., a braid made of round or flat filaments) and a thin elastic sheet of other elements not incorporated into the layer. The outermost receiving layer 2101 may be a tubular structure with a continuous and smooth surface. This facilitates the outer member to abut against it and slide under locally high contact loads (e.g., nested configurations as further described in the invention). Furthermore, the outer layer 2101 may be configured to support compressive loads, such as compression. Furthermore, the outer layer 2101 (e.g., having reinforcing elements) may be configured to prevent the rigidification device 2100 from changing diameter even when pressure is applied.

[0110] Because both the outer layer 2101 and the inner layer 2115 include reinforcing elements, the braided layer 2109 can be reasonably constrained in both diameter shrinkage (under tensile load) and diameter increase (under compressive load).

[0111] The rigidity of the rigidification device 2100 can be increased by using pressure instead of vacuum to convert a flexible state into a rigid state. For example, in some embodiments, the pressure supplied to the pressure gap 2112 can be between 1 and 40 atmospheres, for example, between 2 and 40 atmospheres, for example, between 4 and 20 atmospheres, for example, between 5 and 10 atmospheres. In some embodiments, the supplied pressure is approximately 2 atmospheres, approximately 4 atmospheres, approximately 5 atmospheres, approximately 10 atmospheres, or approximately 20 atmospheres. In some embodiments, the rigidification device 2100 can exhibit a relative bending stiffness (measured in a simple cantilever configuration) variation of 2-100 times from a flexible configuration to a rigid configuration, for example, 10-80 times, for example, 20-50 times. For example, the rigidification device 2100 can have a relative bending stiffness variation of approximately 10, 15, 20 or 25, 30, 40, 50 or more times from a flexible configuration to a rigid configuration. Figure 20 A graph showing the relationship between the bending strength of the rigidification device described in this invention and pressure is presented. As shown in the figure, the bending strength of the rigidification device increases with the increase of the pressure applied to the wall.

[0112] Advantageously, the inner layer having the sublayers and / or overlapping reinforcing elements described herein can be flexible but resistant to high pressure (e.g., pressure acting on the outer diameter of the inner layer that could otherwise cause the tube to collapse). Additionally, the inner layer having the sublayers and / or overlapping reinforcing elements described herein can advantageously provide enhanced torque-carrying capacity or torsional stiffness.

[0113] It should be understood that any feature described herein with respect to one embodiment can be combined with or substituted for any feature described herein with respect to another embodiment. For example, the various layers and / or features of the rigidification device described herein can be combined, replaced, and / or rearranged relative to other layers.

[0114] Other details relating to this invention, including materials and manufacturing techniques, can be adopted at the level of a person skilled in the art. The same applies to the method-based aspects of the invention in terms of additional actions that are generally or logically adopted. Furthermore, it is conceivable that any optional features of the described variations of the invention may be stated and claimed independently, or in combination with any one or more features described in the invention. Similarly, references to singular items include the possibility of the presence of multiple identical items. More specifically, as used in the invention and the appended claims, unless the context clearly indicates otherwise, the singular forms “a,” “and,” “the,” and “the” include plural indicators. It is further noted that claims may be drafted to exclude any optional elements. Therefore, this statement is intended to serve as a priori basis for exclusive terms such as “only,” “just,” etc., in relation to the statement or “negative” limitation of claim elements. Unless otherwise defined in the invention, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The breadth of the invention is not limited by this specification, but only by the general meaning of the terms used in the claims.

[0115] When a feature or element in this invention is described as being "on" another feature or element, it can be directly on the other feature or element, or there may be an intermediate feature and / or element. In contrast, when a feature or element is described as being "directly" on another feature or element, there is no intermediate feature or element. It will also be understood that when a feature or element is described as being "connected," "attached," or "joined" to another feature or element, it can be directly connected, attached, or joined to the other feature or element, or there may be an intermediate feature or element. In contrast, when a feature or element is described as being "directly connected," "directly attached," or "directly joined" to another feature or element, there is no intermediate feature structure or element. Although described or represented relative to one embodiment, the features and elements thus described or represented are applicable to other embodiments. Those skilled in the art will also understand that a structure or feature described as being "adjacent" to another feature arrangement may have a portion overlapping with or located below that adjacent feature.

[0116] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, as used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless otherwise clearly indicated herein. It will also be understood that the terms “comprising” and / or “including” as used herein indicate the presence of the 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 of the associated listed items and may be abbreviated as “ / ”.

[0117] For ease of description, spatial relative terms such as “below,” “below,” “under,” “above,” and “over” may be used herein to describe the relationship of one element or feature to another element or feature shown in the accompanying drawings. It will be understood that spatial relative terms are intended to include different orientations of the device in use or operation, in addition to those shown in the accompanying drawings. For example, if the device in the accompanying drawings is inverted, an element described as being “below” or “under” another element or feature may also be oriented “above” the other element or feature. Thus, the exemplary term “below” can include both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or positioned in other orientations), and the spatial relative descriptions used herein are interpreted accordingly. Similarly, terms such as “up,” “down,” “vertical,” and “horizontal” are used herein for illustrative purposes only, unless otherwise specifically indicated.

[0118] While the terms "first" and "second" may be used herein to describe different features / elements, these features / elements should not be limited by these terms unless otherwise specified herein. These terms are used to distinguish one feature / element from another. Thus, the first feature / element described below may be referred to as the second feature / element, and similarly, the second feature / element described below may be referred to as the first feature / element, without departing from the teachings of the invention.

[0119] As used in the specification and claims of this invention, including as used in the embodiments, unless otherwise expressly stated, all numbers may be read as if preceded by "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 values ​​and / or locations. For example, a numerical value may be + / - 0.1% of a recorded value (or range), + / - 1% of a recorded value (or range), or + / - 2% of a recorded value (or range), + / - 5% of a recorded value (or range), + / - 10% of a recorded value (or range), etc. Any numerical ranges listed in this invention are intended to include all subranges incorporated therein.

Claims

1. A rigidification device, comprising: A slender flexible tube, wherein the slender flexible tube includes a first reinforcing element and a second reinforcing element, and wherein the second reinforcing element is wound in the opposite direction to the first reinforcing element; A bonding layer is located between the first reinforcing element and the second reinforcing element in a direction perpendicular to the longitudinal axis of the rigidification device; A reinforcing layer is located radially outside the slender flexible tube; Outer layer, the outer layer being above the elongated flexible tube and the reinforcing layer; and A vacuum inlet or pressure inlet, which is located between the elongated flexible tube and the outer layer and is configured to be attached to a vacuum source or pressure source; The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

2. The rigidification device according to claim 1, wherein, The reinforcing layer is a braided layer.

3. The rigidification device according to claim 1, wherein, The bonding layer includes an adhesive.

4. The rigidification device according to claim 1, wherein, The first reinforcing element and the second reinforcing element are embedded in a matrix, and the bonding layer comprises the same material as the matrix.

5. The rigidification device according to claim 1, wherein, The first reinforcing element is wound at an angle in the positive direction, and the second reinforcing element is wound at the same angle as the first reinforcing element but in the negative direction.

6. The rigidification device according to claim 1, wherein, The first reinforcing element or the second reinforcing element is wound at an angle greater than 60 degrees and less than 90 degrees relative to the longitudinal axis of the rigidification device.

7. The rigidification device according to claim 1, wherein, The first reinforcing element is located radially outside the second reinforcing element.

8. The rigidification device according to claim 1, wherein, The first reinforcing element and the second reinforcing element are woven together.

9. A rigidification device, comprising: A slender flexible tube, wherein the slender flexible tube includes a first sublayer and a second sublayer, wherein the first sublayer includes a first reinforcing element that forms a first helix around the longitudinal axis of the rigidification device, and wherein the second sublayer includes a second reinforcing element that forms a second helix around the longitudinal axis, wherein the second helix is ​​located above the space between the windings of the first helix; A bonding layer is located between the first sub-layer and the second sub-layer in a direction perpendicular to the longitudinal axis of the rigidification device; A reinforcing layer is located radially outside the slender flexible tube; Outer layer, the outer layer being above the elongated flexible tube and the reinforcing layer; and A vacuum inlet or pressure inlet, which is located between the elongated flexible tube and the outer layer and is configured to be attached to a vacuum source or pressure source; The rigidification device is configured to have a rigid configuration when a vacuum or pressure is applied through the inlet, and a flexible configuration when no vacuum or pressure is applied through the inlet.

10. The rigidification device according to claim 9, wherein, The reinforcing layer is a braided layer.

11. The rigidification device according to claim 9, wherein, The bonding layer includes an adhesive.

12. The rigidification device according to claim 9, wherein, The first reinforcing element and the second reinforcing element are embedded in a matrix, and the bonding layer comprises the same material as the matrix.

13. The rigidification device according to claim 9, wherein, The first reinforcing element is wound in the same direction and with the same pitch as the second reinforcing element.

14. The rigidification device according to claim 9, wherein, The first reinforcing element and the second reinforcing element are each wound at an angle greater than 60 degrees and less than 90 degrees relative to the longitudinal axis of the rigidification device.

15. The rigidification device according to claim 9, wherein, The second reinforcing element radially overlaps with at least a portion of the first reinforcing element.

16. The rigidification device according to claim 9, wherein, The width of the second reinforcing element is 1.5 to 4 times the width of the space between the first spirals.

17. The rigidification device according to claim 9, wherein, The width of the second reinforcing element is smaller than the width of the first reinforcing element.

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