Layered wall for device hardening

Abstract

The stiffening device includes an elongated flexible tube, a stiffening layer disposed radially outward of the elongated flexible tube, an outer layer covering the elongated flexible tube and the stiffening layer, and a vacuum or pressure inlet between the elongated flexible tube and the outer layer, the vacuum or pressure inlet configured to be attached to a vacuum or pressure source. The elongated flexible tube includes a first reinforcing element and a second reinforcing element. The second reinforcing element is counter-wound relative to the first reinforcing element. The stiffening device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 002,202, filed Mar. 30, 2020, entitled "COIL WOUND TUBES FOR RIGIDIZING DEVICES", and U.S. Provisional Patent Application No. 63 / 030,235, filed May 26, 2020, entitled "LAYERED WALLS FOR RIGIDIZING DEVICES", which are hereby incorporated by reference in their entirety.

[0002]

[0002] This application may also be related to International Patent Application No. PCT / US2019 / 042650, filed Jul. 19, 2019, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES" and published as WO2020 / 018934, and / or International Patent Application No. PCT / US2020 / 013937, filed Jan. 16, 2020, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES", which are hereby incorporated by reference in their entirety.

[0003] Incorporation by Reference

[0003] All publications and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Background Art

[0004]

[0004] During a medical procedure, an interventional medical device may bend or loop within an anatomical structure, making it difficult for the medical device to advance.

[0005] Gastrointestinal looping, which is caused when an endoscope cannot advance due to excessive curvature or loops of the gastrointestinal tract, is a particularly well-known clinical problem in endoscopic examinations. In fact, in one study, it was found that looping occurred in 91 out of 100 patients undergoing colonoscopy [Shah et al., "Magnetic Imaging of Colonoscopy: An Audit of Looping, Accuracy and Ancillary maneuvers", Gastrointest Endosc 2000;52:1-8]. Gastrointestinal looping can stretch the blood vessel wall and mesentery, prolonging the procedure and causing pain to the patient. Furthermore, gastrointestinal looping leads to an increased incidence of perforation. In the case of severe gastrointestinal looping, complete colonoscopy is impossible because the looping stretches the length of the colon and the colonoscope is not long enough to reach the end. Gastrointestinal looping also impedes accurate tip control because it does not give the user the desired one-to-one movement relationship between the handle and the endoscope tip. Such problems commonly occur in a wide range of endoscopic procedures, including colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy, endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic procedures (including ESD (Endoscopic Submucosal Dissection) and EMR (Endoscopic Mucosal Resection)), robotic flexible endoscopy, trans-oral robotic surgery (TORS), altered anatomy cases (including Roux-en-Y), and during NOTES (Natural Orifice Transluminal Endoscopic Surgery) procedures. Therefore, there is a need for a device that helps prevent gastrointestinal looping to provide better access to the gastrointestinal tract.

[0006]

[0006] For example, during the insertion procedure in the lungs, kidneys, brain, heart space, and other anatomical locations, similar problems may occur when advancing a medical device. Therefore, there is a need for a device that can provide safe, efficient, and accurate access to anatomical locations that would otherwise be difficult to reach.

Summary of the Invention

[0007]

[0007] Generally, in one embodiment, the stiffening device includes an elongate flexible tube, a stiffening layer disposed radially outside the elongate flexible tube, an outer layer covering the elongate flexible tube and the stiffening layer, and an inlet for vacuum or pressure between the elongate flexible tube and the outer layer, the inlet for vacuum or pressure being configured to be attached to a vacuum or pressure source. The elongate flexible tube includes a first reinforcing element and a second reinforcing element. The second reinforcing element is wound in a reverse winding with respect to the first reinforcing element. The stiffening device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet.

[0008]

[0008] This embodiment and any other embodiment may include one or more of the following features. The stiffening layer may be a braided layer. The stiffening 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 angle may be wound at the same angle in a negative direction. The first reinforcing element or the second reinforcing element may be wound at an angle greater than 60 degrees and less than 90 degrees with respect to the longitudinal axis of the stiffening device. The first reinforcing element may be disposed radially outside the second reinforcing element. The stiffening device may further include a separation layer between the first reinforcing element and the second reinforcing element. The first and second reinforcing elements may be woven together.

[0009]

[0009] Generally, in one embodiment, the curing device includes an elongated flexible tube, a curing layer disposed radially outside the elongated flexible tube, an outer layer covering the elongated flexible tube and the curing layer, and an inlet for vacuum or pressure between the elongated flexible tube and the outer layer, the inlet being configured to be attached to a vacuum 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 the longitudinal axis of the curing device. The second sub-layer includes a second reinforcing element that forms a second helix around the longitudinal axis. The second helix is disposed over the space between the turns of the first helix. The curing device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet.

[0010]

[0010] This embodiment and any other embodiment may include one or more of the following features. The curing layer may be a braided layer. The curing device may further include a bonding layer between the first sub-layer and the second sub-layer. 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 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 with respect to the longitudinal axis of the curing device. The second reinforcing element may overlap radially with at least a portion of the first reinforcing element. The second reinforcing element may have a width that is 1.5 to 4 times the width of the space between the first helices. The second reinforcing element may have a width smaller than the width of the first reinforcing element.

[0011]

[0011] Generally, in one embodiment, the curing device includes an elongated flexible tube, a curing layer disposed radially outside the elongated flexible tube, an outer layer covering the elongated flexible tube and the curing layer, and an inlet for vacuum or pressure between the elongated flexible tube and the outer layer, the inlet for vacuum or pressure being configured to be attached to a vacuum or pressure source. The elongated flexible tube includes a reinforcing element spirally wound around the longitudinal axis of the device. Adjacent turns of the helix overlap radially. The curing device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet.

[0012]

[0012] This embodiment and any other embodiment may include one or more of the following features. The curing layer may be a braided layer. The reinforcing element may be inclined 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 a base material. The reinforcing element may be wound at an angle greater than 60 degrees and less than 90 degrees with respect to the longitudinal axis of the curing device.

[0013]

[0013] The novel features of the present invention are described in detail in the following claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description, which illustrates exemplary embodiments in which the principles of the invention are utilized, and the accompanying drawings.

Brief Description of the Drawings

[0014]

Figure 1

[0014] A diagram showing a curing device.

Figure 2

[0015] A diagram showing a reinforcing layer of a curing device.

Figure 3

[0016] A diagram showing another reinforcing layer of a curing device.

Figure 4A

[0017] A diagram showing a reinforcing layer having two reversely wound reinforcing elements.

Figure 4B

Figure 5

[0018] It is a diagram showing a reinforcing layer having stacked reinforcing elements extending parallel to each other.

Figure 6

[0019] It is a diagram showing a reinforcing layer having reinforcing elements inclined so as to overlap in a continuous winding.

Figure 7

[0020] It is a diagram showing a reinforcing layer having stepped reinforcing elements.

Figure 8

[0021] It is a diagram showing a reinforcing layer having a reinforcing element with an axially extending cover.

Figure 9

[0022] It is a diagram showing a reinforcing layer having alternating flat and inclined windings of reinforcing elements.

Figure 10A

[0023] It is a diagram showing different coil designs for the layers of a curing device.

Figure 10B

Figure 10C

Figure 10D

Figure 10E

Figure 10F

Figure 11A

[0024] It is a diagram showing a corrugated reinforcing element for the layer of a curing device.

Figure 11B

Figure 12A

[0025] It is a diagram showing notch and pocket reinforcing elements for the layer of a curing device.

Figure 12B

Figure 12C

Figure 12D

Figure 12E

Figure 13A

[0026] A diagram showing a cut tube reinforcement element for a layer of a hardening device.

Figure 13B

Figure 13C

Figure 14

[0027] A diagram showing a reinforcing layer element having overlapping reinforcement elements.

Figure 15A

[0028] A diagram showing a torsion layer of a hardening device.

Figure 15B

Figure 15C

Figure 16

[0029] A cross-sectional view of an exemplary reinforcing layer.

Figure 17A

[0030] A diagram showing hardening devices with different hardening shapes.

Figure 17B

Figure 18A

[0031] A diagram showing an exemplary vacuum hardening device.

Figure 18B

Figure 18C

Figure 18D

Figure 19A

[0032] A diagram showing an exemplary pressure hardening device.

Figure 19B

Figure 20

[0033] It is a graph of the bending strength against pressure of the hardening device.

Figure 21A

[0034] It is a diagram showing an exemplary braid formation.

Figure 21B

Figure 21C

Figure 21D

Figure 21E

Figure 22A

[0035] It is a diagram showing an exemplary braid formation.

Figure 22B

Figure 23A

[0036] It is a diagram showing an exemplary braid formation.

Figure 23B

Figure 23C

Mode for Carrying Out the Invention

[0015] Device

[0037] Generally, described herein is a stiffening device (e.g., an overtube) configured to assist in transporting a scope (e.g., an endoscope) or other medical instrument through a curved or looped portion of the body (e.g., a blood vessel). The stiffening device can be long, thin, and hollow and can transition quickly from a flexible configuration (i.e., a relaxed, limp, or floppy configuration) to a rigid configuration (i.e., one that is stiff and / or retains its shape when stiffened). A plurality of layers (e.g., a coiled or reinforcing layer, a slip layer, a braided layer, a bladder layer, and / or a sealing sheath) can together form the wall of the stiffening device. The stiffening device can transition from a flexible configuration to a rigid configuration, for example, by applying a vacuum or pressure to the wall of the stiffening device or within the wall of the stiffening device. When the vacuum or pressure is removed, the layers can easily shear or move relative to each other. When the vacuum or pressure is applied, the layers can transition to a state in which their ability to resist shear, movement, bending, torque, and buckling is significantly improved, thereby effecting stiffening of the system.

[0016]

[0038] The stiffening devices described herein can effect stiffening for a variety of medical applications, including catheters, sheaths, scopes (e.g., endoscopes), wires, overtubes, trocars, or laparoscopic instruments. The stiffening device can function as an individual accessory device or can be integrated into the body of a catheter, sheath, scope, wire, or laparoscopic instrument. The devices described herein can also provide stiffening of non-medical structures.

[0017]

[0039] An example of a hardening device system is shown in FIG. 1. The system includes a hardening device 300 having a wall with a plurality of layers including a braided layer, an outer layer (partially cut away to show the braiding below it), and an inner layer. The system further includes a handle 342 having a vacuum or pressure inlet 344 for supplying vacuum or pressure to the hardening device 300. An operating element 346 is used to turn the vacuum or pressure on and off, thereby enabling the hardening device 300 to transition between a flexible configuration and a rigid configuration. The distal tip 339 of the hardening device 300 is smooth, flexible, non-traumatic, and can facilitate distal movement of the hardening device 300 through the body. Further, the tip 339 tapers from the distal end towards the proximal end, which can further facilitate distal movement of the hardening device 300 through the body.

[0018]

[0040] The hardening device described herein may include an innermost layer configured to provide an inner surface capable of solidifying an additional layer (e.g., a braided layer) when, for example, a vacuum or pressure is applied within the wall of the hardening device. The layer can further provide a seal for the wall (i.e., can prevent leakage) and have sufficient strength to provide resistance against diametrical collapse even during bending and / or compression of the hardening device during hardening. Referring to FIG. 2, in some embodiments, the innermost layer 8815 may include a reinforcing sublayer 8840y that includes coils within a reinforcing element 8850z or a base material 8851z. The reinforcing element 8850z can be a continuous helical coil or a closed ring having gaps therebetween (which may exhibit more resistance to collapse than a helical coil). When configured as a helical coil, the reinforcing element 8850z can be helical with a constant pitch or a variable pitch. Further, the inner layer 8815 may include an inner film 8852z and an outer film 8853z on one or both of its sides. In some embodiments, each of the elements 8853z, 8852z, 8850z, 8851z may have a thickness of from 0.000508 cm (0.0002 inches) to 0.0381 cm (0.015 inches), more precisely from 0.00127 cm (0.0005 inches) to 0.00254 cm (0.001 inches).

[0019]

[0041] The reinforcing element 8850z can be, for example, a metal wire such as a metal wire made of stainless steel, nitinol, or tungsten. The reinforcing element 8850z can 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 stent, a structure cut from a tube, or a braid. In some embodiments, the reinforcing element 8850z can be a round wire (for example, with a diameter of 0.00254 cm (0.001 inch), 0.00762 cm (0.003 inch), 0.0127 cm (0.005 inch), 0.01778 cm (0.007 inch), or 0.02286 cm (0.009 inch), etc., with a diameter ranging from 0.00127 cm (0.0005 inch) to 0.0762 cm (0.030 inch)). In some embodiments, the reinforcing element 8850z can be a flat wire (for example, with a width ranging from 0.00254 cm (0.001 inch) to 0.254 cm (0.100 inch), such as 0.0254 cm (0.010 inch), 0.0508 cm (0.020 inch), 0.0762 cm (0.030 inch), 0.1016 cm (0.040 inch), 0.127 cm (0.050 inch), 0.1524 cm (0.060 inch), 0.1778 cm (0.070 inch), 0.2032 cm (0.080 inch), 0.2286 cm (0.090 inch), or 0.254 cm (0.100 inch), and / or a thickness ranging from 0.000762 cm (0.0003 inch) to 0.0508 cm (0.020 inch), such as 0.00254 cm (0.001 inch), 0.00762 cm (0.003 inch), 0.0127 cm (0.005 inch), 0.01778 cm (0.007 inch), or 0.0254 cm (0.010 inch)). In other embodiments, the reinforcing element 8850z can have an elliptical cross-section, and / or can include a plurality of individual strands, and / or can have a rectangular cross-section with four sharp corners rounded. In some embodiments, the reinforcing element 8850z can be cut from a single tube, for example, by using a laser to create a gap. In some embodiments, no reinforcing element is used.In some embodiments, the reinforcing element 8850z can be textured (e.g., to improve adhesion and / or shear between adjacent layers). Texturing can be provided, for example, by shot blasting or sand blasting, a polishing wheel or wipe, or a texturing wheel that imprints a pattern.

[0020]

[0042] In some embodiments, the reinforcing element 8850z can be an element having a high aspect ratio, such as an aspect ratio greater than 5:1, greater than 10:1, greater than 11:1, about 12:1, etc. (e.g., having a high RE width relative to the RE height). Note in Figure 2 that the RE width is the width of the reinforcing element 8850z, the RE height is the height or thickness of the reinforcing element 8850z, and the RE gap is the distance between the reinforcing elements 8850z. A high ratio of the width to the height of the reinforcing element 8850z can advantageously serve to prevent the external pressure that causes the parallelogram-shaped collapse of the reinforcing element 8850z within the innermost layer 8815. When the helix of the coil moves in a direction from being substantially perpendicular to the central axis of the coil to being parallel to the central axis of the coil, a parallelogram-shaped collapse can occur (the helix essentially "flips over"). Further, if the RE gap between the reinforcing elements 8850z is less than three times the RE height, such as less than twice the RE height, less than 1.5 times the RE height, etc., it can be advantageous in preventing the parallelogram. Further, 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 being less than 5, such as less than 4.5, such as about 4.3, can similarly serve to prevent the parallelogram-shaped collapse.

[0021]

[0043] The base material 8851z can be a very low durometer such as 60A, 50A, 40A, 30A, 20A, or 10A or less on the durometer, for example TPU or TPE. In some embodiments, the base material 8851z can be TPU, TPE, PET, PEEK, Mylar, urethane, or silicone. The inner and outer films 8852z, 8853z can similarly include TPU, TPE, PET, PEEK, Mylar, urethane, or silicone. In some embodiments, the inner and outer films 8852z, 8853z can be applied by spraying, dipping, wrapping as a sheet or tube, pulling through a solvent bath, melting, and / or solidifying. In some embodiments, the layer 8815 does not include the inner and / or outer films 8852z, 8853z and / or can include additional films. The inner and / or outer films 8852z, 8853z can create smooth inner and outer surfaces.

[0022]

[0044] In a specific example of the innermost layer 8815 for a pressure system, the layer is made with an inner diameter of 0.6604 cm (0.260 inches) as a hollow tube having an RE width of 0.127 cm (0.050 inches), an RE height of 0.02032 cm (0.008 inches), and an RE gap of 0.0254 cm (0.010 inches). The film 8853z has both sides omitted. The film 8852z (both sides of the base material 8851z and the reinforcing element 8850z) is all made of urethane (100% strain from 4137 kPa (600 psi)). The thickness of both the base material 8851z and each film 8852z is about 0.01524 cm (0.006 inches), and the total wall thickness is 0.04572 cm (0.018 inches). This structure can withstand being crushed by an external pressure exceeding 10 atmospheres.

[0023]

[0045] In a second specific example of the innermost layer 8815 for a pressure system, the film 8853z is omitted on both sides. The RE width is 0.127 cm (0.050 inches), the RE height is 0.02032 cm (0.008 inches), and the RE gap is 0.0254 cm (0.010 inches). The film 8852z is an elastomer with a higher durometer, for example, an elastomer having a stress of 13790 kPa (2000 psi) at 100% strain and a thickness of about 0.00254 cm (0.001 inches). The base material 8851z may be 50A urethane. The base material 8851z can be deposited as a thermoplastic elastomer cord stock, for example, with a rectangular cross-section of 0.02032 cm (0.008 inches) or a circular cross-section of 0.0254 cm (0.010 inches). This cord stock can also be deposited by extruding a wire (such as a wire with a diameter of 0.00254 cm (0.001 inches)) or a fiber together with the core to increase the axial modulus of elasticity (not the transverse modulus of elasticity).

[0024]

[0046] In a third specific example of the innermost layer 8815 for a pressure system, the reinforcing element 8850z can be a wire having a high aspect ratio. For example, the layer 8815 can have an RE height of 0.0127 cm (0.005 inches), an RE width of 0.1524 cm (0.060 inches), and an RE gap of 0.01524 cm (0.006 inches) in a rectangular stainless steel wire. The inner diameter of the tube formed by the innermost layer 8815 is 0.6604 cm (0.26 inches). The elements 8852z and 8851z are 80A urethane and can have a thickness of about 0.00508 cm (0.002 inches). Further, the layer 8851z can be 50A urethane (for example, deposited from a heating tank containing molten urethane and an orifice for accurate distribution via pressure). The structure of this exemplary innermost layer 8815 can withstand collapse under an external pressure exceeding 10 atm, such as a pressure exceeding 12 atm, a pressure exceeding 13 atm, etc.

[0025]

[0047] In a specific example of the innermost layer 8815 of the vacuum system, one side (e.g., the outer or upper surface) of the outer film 8853z is omitted. The film 8852z on the upper (outer) side of the reinforcing material / base material contains 50A urethane with a thickness of 0.0127 cm (0.005 inches). The base material 8851z is made of 50A urethane with a thickness of 0.0127 cm (0.005 inches). The reinforcing element 8850z is a stainless steel wire. The film 8852z under the reinforcing material / base material (inner side) contains 50A urethane with a thickness of 0.00635 cm (0.0025 inches). The lower outer film 8853z is 80A urethane with a thickness of 0.01016 cm (0.004 inches). The RE width is 0.0508 cm (0.020 inches), the RE height is 0.0127 cm (0.005 inches), and the RE gap is 0.0254 cm (0.010 inches). The lower outer film 8853z is hydrophilic coated. The inner diameter of the tube formed by the layer 8815 is 1.4 cm (0.551 inches).

[0026]

[0048] Although shown symmetrically in Figure 2, it should be understood that the innermost layer 8815 does not necessarily have a symmetric arrangement of the films 8852z and 8853z. For example, both layers may be present at the top while neither layer is at the bottom (inside the base material / reinforcing material). Furthermore, it should be understood that the materials of both the innermost films 8852z do not have to be the same, and the materials of both the outermost films 8853z do not have to be the same either.

[0027]

[0049] Another exemplary innermost layer 315 is shown in Figure 3. The layer 315 is similar to the layer 8815 except that it includes an additional reinforcing sublayer 341y containing one or more reinforcing elements 342y within the base material 343y (i.e., in addition to the sublayer 340y having the reinforcing element 350z and the base material 351z). Furthermore, a bonding sublayer 344y may be disposed between the reinforcing sublayers 340y and 341y. Similar to the innermost layer 8815, the layer 315 may include inner and outer films 352z and 353z respectively.

[0028]

[0050] The reinforcing sublayer 341y may be the same as or different from the reinforcing sublayer 340y. For example, the reinforcing sublayer 341y may include reinforcing elements and / or base materials of the same material, size, and shape as the reinforcing sublayer 340y, or may include reinforcing elements and / or base materials of different materials, sizes, and shapes from the reinforcing sublayer 340y. In one particular example, one of the reinforcing sublayers 340y, 341y may include a reinforcing element of a flat stainless steel wire of 0.0127 cm (0.005 inches) × 0.0762 cm (0.030 inches), and the other reinforcing sublayer may include a reinforcing element of a flat stainless steel wire of 0.00508 cm (0.002 inches) × 0.0508 cm (0.020 inches). In another particular embodiment, the reinforcing element of one of the reinforcing sublayers 340y, 341y may include a round cross-section, and the other may include a reinforcing element with a flat cross-section (e.g., a flat rectangle with a width-to-thickness ratio between 10:1 and 200:1). As another example, the reinforcing sublayers 340y, 341y may have the same or different thicknesses.

[0029]

[0051] The joining sublayer 344y can be made of the same or different base material as the base materials 351z, 343y and / or the adhesive, and can advantageously prevent the reinforcing elements 350z, 342y from shearing against each other during bending of the layer 315, thereby further helping to prevent the layer 315 from collapsing. In some embodiments, the base materials 351z, 343y and / or the joining sublayer 344y can be applied by bath, immersion, or spraying as a laminate sheet or tube. In some embodiments, the layer 315 may not include the joining sublayer 344y.

[0030]

[0052] In some embodiments, the base materials 351z, 343y and / or the bonding sublayer 344y can be applied via a bath, immersion, spraying, or via a flat sheet element that is applied and co-bonded by lamination. In some embodiments, the lamination layer (and / or the individual base materials 351z, 343y, or bonding sublayer 344y) can be applied as a tube. In some embodiments, the tube can be applied as constructed (e.g., as an extrusion). In other embodiments, the tube can be applied and axially loaded and stretched over a mandrel to give both a significant change in length (e.g., twice, three times, or four times the original length) and a corresponding decrease in wall thickness (e.g., resulting thicknesses of one-half, one-third, or one-fourth the original thickness, respectively).

[0031]

[0053] The additional reinforcing sublayer 341y, in combination with the reinforcing sublayer 340y, can advantageously serve to prevent the innermost layer 315 from collapsing (e.g., while pressure is being applied to layer 315). In some embodiments, the additional sublayer 341y may also increase torsional resistance.

[0032]

[0054] In one embodiment, the reinforcing sublayer (e.g., 340y, 34ly) may include reinforcing elements that do not extend parallel to each other. For example, an exemplary inner layer 415 having two reinforcing sublayers 440y, 441y separated by a bonding sublayer 444y is shown in FIGS. 4A-4B (additional components such as the inner film and the outer film are removed for clarity). Each reinforcing sublayer 440y, 441y may include one or more reinforcing elements 450z, 442y within the base materials 451z, 443y. In some embodiments, the reinforcing elements 450z and 442y may have substantially the same width. Further, the reinforcing elements 450z, 442y can be wound in opposite directions with respect to each other. That is, as shown in FIG. 4B, the reinforcing element 450z of layer 440y can be wound helically at a negative angle α (e.g., from 0.5 degrees to 25 degrees, from 2 degrees to 15 degrees, etc., up to a maximum negative angle of 30 degrees) with respect to an axis 448y perpendicular to the longitudinal axis 435 of the curing device. In contrast, the reinforcing element 442y of the reinforcing sublayer 441y can be wound helically at a positive angle β (e.g., from 0.5 degrees to 25 degrees, from 2 degrees to 15 degrees, etc., up to a maximum positive angle of 30 degrees) with respect to the axis 448y. The tendency of the reinforcing element 450z to tilt in response to compression can be reduced by winding the reinforcing element 442y thereon at the opposite angle. An exemplary method of manufacturing layer 415 includes, for example, winding the reinforcing element 450z from left to right, adding the bonding sublayer 444y, and then winding the reinforcing element 442y from right to left. In some embodiments, the reverse winding angle can be adjusted by including multi-start winding, as described below with respect to FIGS. 10A-10F.

[0033]

[0055] In some embodiments, rather than having two separate reinforcing sublayers 440y, 441y, the reinforcing elements 450z, 442y of opposite angles can be arranged alternately with each other, like a braid (i.e., passing over and under each other). In such embodiments, the bonding sublayer 44y may be omitted.

[0034]

[0056] In some embodiments, the reinforcing sub-layers (e.g., 340y, 341y) may include reinforcing elements that extend parallel to each other but overlap across the spacing between the reinforcing elements (i.e., across the base material). For example, an exemplary innermost layer 515 having two reinforcing sub-layers 540y, 541y separated by a bonding sub-layer 544y is shown in FIG. 5. Thus, as shown in FIG. 5, layer 515 may include an outer film 553z, an inner film 552z, a sub-layer 540y having a reinforcing element 550z (and the base material removed from FIG. 5 for clarity), a bonding sub-layer 544y, and a sub-layer 541y including a reinforcing element 542y (and the base material removed from FIG. 5 for clarity). The reinforcing element 542y may extend in the same direction and / or at the same angle or pitch as the reinforcing element 550z. Further, the reinforcing element 542y of the reinforcing sub-layer 541y can be disposed over the gap (or base material) between the reinforcing elements 550z of the reinforcing sub-layer 540y. Further, the reinforcing element 542y can be disposed to overlap one or both of the underlying reinforcing elements 550z. In some embodiments, the outer reinforcing element 542y may have a width that is 1.5 to 4 times, such as 2 to 3 times, the width of the base material or the spacing between the reinforcing elements 550z (e.g., so as to span the entire gap even when the curing device is bent). Overlaying the reinforcing element 542y over the gap or base material portion between the reinforcing elements 550z can advantageously serve to prevent crushing or penetration of the inner layer 515 in the base material. Further, the second reinforcing sub-layer 541y can serve to prevent the first sub-layer 540y from tipping over during pressing. In some embodiments, the outer reinforcing element 542y can be thinner than the inner reinforcing element 550z, or have a smaller width or diameter, which can advantageously serve to maintain the integrity of the inner reinforcing element 550z when pressurized. In some embodiments, the outer reinforcing element 542y can be made of plastic (e.g., PEEK), and the inner reinforcing element 550z can be made of metal.

[0035]

[0057] Another exemplary innermost layer 615 is shown in FIG. 6 (for clarity, layers such as the inner film and the outer film are removed). The innermost layer 615 may include a single reinforcing sublayer 640y that includes reinforcing elements 650z that are inclined at an angle such that the width w of the reinforcing elements 650z is greater than the pitch length. Thus, adjacent windings of the reinforcing elements 650z may overlap each other (see overlapping zone 645y and non-overlapping zone 646y). For example, the width w of the reinforcing element may be about 0.0762 cm (0.03 inches), the pitch may be about 0.0508 cm (0.02 inches), and there may be an overlapping zone 645y of about 0.00762 cm (0.003 inches) to 0.0127 cm (0.005 inches). The overlapping reinforcing elements 650z can advantageously help prevent the layer 615 from collapsing during pressing.

[0036]

[0058] Another exemplary innermost layer 715 is shown in FIG. 7. The reinforcing elements 750z of the reinforcing sublayer 740y may have a stepped or stepped cross-sectional structure configured such that the inner portion of the first reinforcing element 750z overlaps the outer stepped or stepped portion of the adjacent reinforcing element 750z. Thus, the adjacent reinforcing elements 750z can overlap each other, which can advantageously help prevent the layer 715 from collapsing during pressing. The reinforcing elements 750z can be tapered, straight, rounded, or wavy in shape (i.e., have a cross-section).

[0037]

[0059] Another exemplary innermost layer 2415 is shown in FIG. 14. The reinforcing elements 2450z of the reinforcing sublayer 2440y may have a cross-sectional shape similar to a tuning fork having two (outer and inner) laterally / axially extending features. Adjacent reinforcing elements 2450z may fit between the laterally / axially extending features and may overlap. Again, the overlapping reinforcing elements 2450z can advantageously help prevent the layer 2415 from collapsing during pressing.

[0038]

[0060] Another exemplary innermost layer 815 is shown in FIG. 8. The reinforcing element 850z of layer 840y may include a cover 847y that extends axially therefrom so as to cover the base material 851z between the reinforcing elements 850z. The cover 847y may have a thickness (e.g., in the radial direction) that is smaller than the thickness of the reinforcing element 850z (e.g., the thickness of the cover 847y may be less than 50%, less than 40%, less than 30%, or less than 20% of the thickness of the reinforcing element 850z). Further, as shown in FIG. 8, the cover 847y may be overlaid on and / or overlap the outer surface of the reinforcing element 850z. In some embodiments, the cover 847y may be, for example, a thin metal or plastic joined to the reinforcing element 850z.

[0039]

[0061] Another exemplary innermost layer 915 is shown in FIG. 9. 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 flattened (i.e., can be flattened along the circumference of the curing device), and the adjacent reinforcing element 950z can be angled (i.e., with respect to the circumference of the curing device). The angled reinforcing element 950z may extend from under the first flat reinforcing element 950z to above the second flat reinforcing element 950z. Adjacent reinforcing elements 950z can be helical with a substantially same pitch. In some embodiments, adjacent reinforcing elements 950z can be connected together (e.g., joined by adhesion, welding, or other methods).

[0040]

[0062] The use of the plurality of sub-layers and / or overlapping reinforcing elements described herein can enhance pressure resistance and / or torsional resistance.

[0041]

[0063] The innermost reinforcing element may be of various additional configurations. As shown in FIGS. 10D - 10F, the reinforcing element 9205z may be a multi - start coil winding (e.g., 2 - start as shown in FIG. 10F, 3 - start as shown in FIG. 10E, or 4 - start as shown in FIG. 10D). When using a multi - start coil winding, the gap between the reinforcing elements along the longitudinal axis may be the same as in the case of a single - coil, but the number of starts may be 2, 3, 4, 5, 6, 7, 8, 9 or more. In a single - start, a wire angle that is approximately perpendicular (e.g., an angle deviated 2 degrees from perpendicular) is created, while in a multi - start approach, a wire angle is created that tilts the coil in a direction much further from perpendicular (e.g., 4, 6, 10, 15, or even 20 degrees). Coils with a larger pitch tend to support each other for stability, so this larger angle can help reduce the likelihood that the innermost layer tilts or structurally collapses under pressure. FIGS. 10A - 10C show individual starts (coils) from the multi - start reinforcing element 9205Z. FIG. 10C shows one coil from FIG. 10F, FIG. 10B shows one coil from FIG. 10E, and FIG. 10A shows one coil from FIG. 10D. In some embodiments, the multi - start can be used in multiple reinforcing sub - layers to provide overlapping reinforcing elements. The multi - start count can be adjusted to adjust the reinforcing angle with respect to the central axis of the device. Further, the multi - start element can be a solid single - filament or a multi - filament element such as a strand or a cable.

[0042]

[0064] Any of the helical or coiled reinforcing elements described herein can be replaced or combined with other reinforcing elements such as laser - cut tubes, individual wire segments, injection - molded elements, case elements, pivoted links, or bent links.

[0043]

[0065] For example, in some embodiments, referring to FIGS. 11A - 11B, the reinforcing element 8950z may be a series of wavy or undulated wires (or wavy wires wound as described herein). As shown in FIG. 11B, when a load is applied to the device, the wavy reinforcing element 8950z moves in a direction where it collides with itself, compresses the base material 8851Z between the wires, and resists parallelogram - shaped crushing. In one particular embodiment, the innermost layer having such wavy wires may have an RE height of 0.0127 cm (0.005 inches), an RE width of 0.1524 cm (0.060 inches), and an RE gap of exactly 0.01524 cm (0.006 inches). The undulating waves can vary from the center line by + / - 0.0762 cm (0.03 inches) (i.e., the amplitude of the wave is 0.1524 cm (0.060 inches)). The waves may repeat every 0.762 cm (0.3 inches) (i.e., the wavelength is 0.762 cm (0.3 inches)).

[0044]

[0066] In some embodiments, referring to FIGS. 12A - 12C, the reinforcing element 9050z may alternately include pocket wires 9052z and notch wires 9053z. When the load is removed, the pockets and notches of each element can separate (as shown in FIG. 12D). However, when a load is applied, the notches of wire 9053z move in a direction where they collide with the pockets of wire 9052z (as shown in FIG. 12E), compress the base material 8851z between the wires, and resist parallelogram - shaped crushing.

[0045]

[0067] In some embodiments, referring to FIGS. 13A - 13C, the reinforcing element 9150z may be a flexure design, for example, a laser cut from a metal or plastic tube. In some embodiments, the flexure design can be configured to bend radially while resisting shrinkage and / or expand and contract. FIG. 13C shows an exemplary flexure design of the reinforcing element 9150z that allows for radial expansion (e.g., to facilitate assembly and manufacturing) and provides a radial hard stop under pressure (e.g., to prevent crushing).

[0046]

[0068] In some cases, the reinforcing element can be separated from the inner layer. For example, the reinforcing element can be disposed on the inner or outer side in the diameter direction of the inner layer. The innermost layer may have a hardness of, for example, 30A to 80A. Further, the innermost layer may have a wall thickness of 0.00127 cm (0.0005 inches) to 0.1524 cm (0.060 inches). In some embodiments, the innermost layer may include a lubricant or a coating (e.g., a hydrophilic coating) on its inner surface to improve the sliding of an endoscope or other instrument passing therethrough. The coating may be hydrophilic (e.g., Hydromer® coating or Surmodics® coating) or hydrophobic (e.g., fluoropolymer). The coating can be applied, for example, by dipping, painting, or spraying the coating thereon. The innermost layer allows for the lamination of a low coefficient of friction.

[0047]

[0069] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the base material surrounding the reinforcing element can be composed of a material with high hydrolysis stability. That is, it is advantageous for the curing device described herein to maintain its structural integrity when exposed to an immersion fluid environment such as water, physiological saline, gastric juice, or blood. When the base material is hygroscopic and absorbs fluid, the fluid acts as a plasticizer, softening the base material, and as a result, the resistance to collapse of the pressurized (or vacuum-induced) structure decreases, and as a result, the rigidity of the device may decrease. Thus, in some embodiments, the base material can be made of a hydrophobic material, thereby hardly or not absorbing fluid at all and advantageously maintaining its structural integrity even when immersed in fluid. For example, the base material can be made of polyethylene, polypropylene, polystyrene, thermoplastic elastomers (such as Chronoprene™ and Teknor Apex Medalist™), or polyvinyl chloride. As another example, the base material can be made of a composite solution such as a styrene block copolymer (SBC) such as styrene-ethylene-butylene-styrene (SEBS), styrene-butadiene-styrene copolymer (SBS), or Kraton® containing a polystyrene block and a rubber block (such as a rubber block of polybutadiene or polyisoprene). In some embodiments, the base material may contain an additive that strengthens the bond, such as maleic anhydride.

[0048]

[0070] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the reinforcing element and the base material can be bonded with an adhesive. For example, the reinforcing element can be immersed, sprayed, or dip-coated with the adhesive, and then the reinforcing element can be placed within the base material to co-bond the base material and the reinforcing element. In some embodiments, the reinforcing element and the base material can have a resulting bond strength of up to 22.68 kg (50 pounds) per 6.452 square cm (1 square inch). The adhesive can be, for example, Chemlok™ adhesive. By adhering the reinforcing element to the base material using an adhesive, the reinforcing layer can remain intact and withstand pressure and / or vacuum collapse.

[0049]

[0071] For any of the reinforcing layers described herein (e.g., the innermost layer 8815), the reinforcing layer can be manufactured such that it has its net (i.e., as manufactured) diameter or a final diameter close thereto (i.e., within the curing device), thereby ensuring that the base material does not need to hold the reinforcing element at 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, such as within 2% of the net diameter. Having a final diameter close to the net diameter can advantageously ensure that the internal stress of the reinforcing layer is reduced, thereby reducing creep and / or breakage of the reinforcing layer. In some embodiments, the reinforcing element can be manufactured by yielding the reinforcing element when the reinforcing element is applied to the base material, for example, by passing the reinforcing element through a series of deformable rollers.

[0050]

[0072] Any of the layers described in this specification may include a plurality of reinforcing sub-layers laminated adjacent thereto (e.g., similar to sub-layers 340y, 341y). For example, the innermost layer may include a sub-layer thereon (e.g., instead of being embedded therein). The sub-layer may include, for example, one or more ribbons or wires wound spirally at an angle (e.g., at an angle less than 90 degrees, such as greater than 60 degrees and less than 90 degrees, from 65 degrees to 89.5 degrees, from 75 degrees to 88 degrees, etc., with respect to the longitudinal axis of the curing device). For example, as shown in FIGS. 15A - 15C, the innermost layer 8715 may have a first sub-layer 8702a wound thereon in a first direction and a second sub-layer 8702b wound thereon in a second opposite direction (e.g., the first sub-layer 8702a may be wound at 70 degrees with respect to the longitudinal axis or the horizontal axis, and the second sub-layer 8702b may be wound at -70 degrees). By adding layers 8702a and 8702b, the torsional resistance of the completed device can be increased. In some embodiments (e.g., embodiments where an increase in flexibility is desired), the two sub-layers 8702a, 8702b may be able to shear or slide relative to each other. For example, there may be a slip layer between the two layers 8702a, 8702b. In some embodiments, a slip layer may be present between the two sub-layers and / or between other layers of the device (e.g., the innermost layer). In some embodiments, the additional sub-layers 8702a, 8702b may be part of or woven with another layer (e.g., a braided layer). In embodiments where an increase in torsional rigidity is desired, the sub-layer may be made of a material (such as sheet metal or wire) that can withstand both high tensile loads and high compressive loads, or a material (such as multiple small-diameter wires or fibers) that can withstand high tensile loads but can only withstand a small compressive load.

[0051]

[0073] Any of the reinforcing layers described herein (e.g., the innermost layer 8815) may be configured to include alternating types of materials along the longitudinal axis of the device. For example, referring to FIG. 16, layer 18815 can include alternating sections 18807y and 18806y of high durometer material and low durometer material, respectively. Further, section 18807z of the high durometer material can include reinforcing element 18850z embedded therein. In some embodiments, alternating sections 18807y and 18806y can be formed by spiraling section 18807y, leaving a gap between the spirals, and then filling the gap with a material having a lower durometer hardness for section 18806y. This design advantageously allows layer 18815 to have high rigidity in section 18807y while allowing flexibility and bending at the hinge points created by section 18806y. Thus, a device incorporating layer 18815 can have high rigidity and resistance to pressure / vacuum collapse while still maintaining a high baseline flexibility.

[0052]

[0074] Referring to FIGS. 21A - 21E, any braiding of the curing device described herein may be in various different braiding patterns. For example, referring to FIG. 21A, the braiding of layer 1709 may be a diamond full - load pattern where two adjacent strands 1733a, b extend over two strands and then under two strands. Referring to FIG. 21B, the braiding of layer 1709 may be a full - load pattern where each strand 1733a extends over two strands and under two strands in a manner opposite to that of the adjacent strand 1733b. Referring to FIG. 21C, the braiding of layer 1709 may be a diamond half - load pattern where each strand 1733a extends over one strand and under one strand on the side opposite to the adjacent strand 1733b. Referring to FIGS. 21D and 21E, the braiding of layer 1709 may include one or more vertical strands 1733c passing through the intersecting strands 1733a, 1733b. The vertical strands 1733c may be discontinuous (as shown in FIG. 21D) or continuous (as shown in FIG. 21E). Further, in some embodiments, as shown in FIG. 21E, the vertical strand 1733c can pass over the first strand junction 1740a of the braiding strands 1733a, 1733b and under the second junction 1740b of the braiding strands 1733a, 1733b. In some embodiments, the upper and lower junctions 1740a, 1740b may be adjacent to each other. In other embodiments, the upper and lower junctions 1740a, 1740b may be separated by 2 - 50 junctions, such as 2, 3, 4, 10, 20, or 40 junctions from each other.

[0053]

[0075] Any strand of the braided layer described in this specification can be rectangular / flattened (e.g., with long sides of 0.0127 cm (0.005 inches), 0.01778 cm (0.007 inches), 0.0254 cm (0.010 inches), 0.03048 cm (0.012 inches), etc., from 0.00254 cm (0.001 inches) to 0.1524 cm (0.060 inches), and short sides of 0.00254 cm (0.001 inches), 0.00508 cm (0.002 inches), 0.00762 cm (0.003 inches), etc., from 0.000762 cm (0.0003 inches) to 0.0762 cm (0.030 inches)), circular (e.g., with diameters of 0.0127 cm (0.005 inches), 0.0254 cm (0.01 inches), 0.03048 cm (0.012 inches), etc., from 0.00254 cm (0.001 inches) to 0.0508 cm (0.020 inches)), or elliptical. In some embodiments, some of the strands can be flat and some of the strands 233 can be circular.

[0054]

[0076] Referring to FIGS. 22A-22B, each strand 1833 may include a single filament 1818 (FIG. 22A) or multiple filaments 1818a-c (three filaments 1818a-c are shown for each strand 1833 in FIG. 22B). The filaments 1818 can be selected to reduce crimp (the waviness or bending of the filaments) (i.e., the diameter, spacing, and modulus of elasticity can be specifically adjusted). As the crimp decreases, the compressive buckling resistance of the system improves, and the stiffness of the system can improve. Referring to FIGS. 23A-23C, each strand 2333 may include a plurality of filaments 2318 bundled together (i.e., twisted, woven, or braided). For example, there may be 2-20 filaments 2318 such as 5-10 filaments 2318 such as 7 filaments (as shown in FIGS. 23A-23C). In some embodiments, each of the filaments 2318 can have a diameter of from 0.00127 cm (0.0005 inches) to 0.0254 cm (0.010 inches), such as about 0.00508 cm (0.002 inches), 0.00254 cm (0.001 inches) to 0.127 cm (0.05 inches), etc.

[0055]

[0077] In some embodiments, the strand or filament may be made of metal (e.g., stainless steel, aluminum, nitinol, tungsten, or titanium), plastic (nylon, polyethylene terephthalate, PEEK, polyetherimide), or high-strength fiber (such as aramid, ultra-high molecular weight UHMW polyethylene, liquid crystal polymers such as Vectran, etc.). In some embodiments, the strand may include filaments made of two or more different materials (e.g., some filaments within the strand may be nitinol and some may be stainless steel). In some embodiments, the strand or filament can be made of a multilayer composite material such as a thin elastomer, plastic, hard epoxy, or a metal core with an enamel coating. Coating the strand or filament with a hard material such as hard epoxy or enamel can, in some embodiments, help prevent the strand or filament from yielding during use of the curing device. In one specific example, the strand may include round nylon with a diameter of 0.0254 cm (0.010 inches) (or a metal filament with a diameter of 0.00762 cm (0.003 inches)) twisted with flat aluminum-treated PET with a cross-sectional dimension of 0.00508 cm (0.002 inches) × 0.00508 cm (0.002 inches).

[0056]

[0078] In some embodiments, the material of the braided strand may be a material having a known high coefficient of friction. For example, the strand may be a monolithic structure, or the strand can have a coating such that it includes aluminum on aluminum, copper on copper, silver on silver, or gold on gold. As another example, the strand can be coated with an elastomeric material (e.g., an elastomer with a lower durometer hardness can be coated on a substrate with a higher modulus of elasticity). As another example, the strand can be made of a styrene copolymer, polycarbonate, or acrylic.

[0057]

[0079] Within the braided layer, there can be 12 to 800 strands, such as 24, 48, 96, 120, 144 or more strands extending within the braided layer. In some embodiments, there are 96 or more strands, 120 or more strands, 200 or more strands, or 240 or more strands. When the number of strands is large, the interaction between the strands increases, which can be advantageously useful for the hardening of the braid.

[0058]

[0080] In some embodiments, the braided layer may be integrated with or embedded in any base material of the reinforcing layer (e.g., the innermost layer 8815).

[0059]

[0081] Exemplary hardening devices in the hardened configuration are shown in FIGS. 17A and 17B. When the hardening device hardens, it becomes in the shape before the application of vacuum or pressure, that is, it does not become straight, bent, or otherwise significantly change its shape (e.g., it can be hardened in a loop shape as shown in FIG. 17A or in a convoluted shape as shown in FIG. 17B). This is because the air hardening effect on the inner layer or outer layer (such as a coiled tube) can be a small percentage (such as 5%) of the maximum load capacity of the hardening device during bending, which enables the hardening device to resist becoming straight. When the vacuum or pressure is released, the braid or strands are unlocked with respect to each other and can move again to bend the hardening device. Also in this case, when the hardening device becomes more flexible by releasing the vacuum or pressure, it becomes in the shape before the release of the vacuum or pressure, that is, it does not become straight, bent, or otherwise significantly change its shape. Therefore, the hardening device described herein can transition from a flexible and less rigid configuration to a more rigid configuration by restricting the movement between the braided strands (e.g., by applying vacuum or pressure).

[0060]

[0082] The hardening device described in this specification can be quickly switched between a rigid configuration and a flexible configuration, and in some embodiments, can be switched in an indefinite transition cycle. As interventional medical devices have become longer and are inserted deeper into the human body, and more precise treatment procedures are expected, the need for accuracy and control has increased. Selectively hardening the devices described in this specification (e.g., overtube) can advantageously provide both the advantages of flexibility (when needed) and the advantages of rigidity (when needed). Further, the hardening device described in this specification can be used with conventional endoscopes, colonoscopes, robotic systems, and / or navigation systems, such as those described in International Patent Application No. PCT / US2016 / 050290, filed on September 2, 2016, and titled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE," which is hereby incorporated by reference in its entirety.

[0061]

[0083] The hardening device described in this specification may additionally or alternatively include any of the features described in International Patent Application No. PCT / US2016 / 050290, filed on September 2, 2016, entitled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE" and published as WO2017 / 041052, which is incorporated herein by reference in its entirety; International Patent Application No. PCT / US2018 / 042946, filed on July 19, 2018, entitled "DYNAMICALLY RIGIDIZING OVERTUBE" and published as WO2019 / 018682; International Patent Application No. PCT / US2019 / 042650, filed on July 19, 2019, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES" and published as WO2020 / 018934; and International Patent Application No. PCT / US2020 / 013937, filed on January 16, 2020, entitled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES".

[0062]

[0084] The hardening device described in this specification can be provided in a plurality of configurations including different lengths and diameters. In some embodiments, the hardening device can include a working channel (e.g., to allow passage of a typical endoscopic tool within the body of the hardening device), a balloon, a nested element, and / or a side-loading feature.

[0063]

[0085] Referring to FIGS. 18A - 18D, in one embodiment, the tubular hardening device 100 may include a wall having a plurality of layers disposed around the lumen 120 (e.g., for disposing an instrument or an endoscope through the lumen). A vacuum can be supplied between the layers to harden the hardening device 100.

[0064]

[0086] The innermost layer 115 can be configured to provide an inner surface that can solidify the remaining layers when a vacuum is applied within the walls of, for example, the curing apparatus 100. The structure can be configured to minimize bending forces / maximize flexibility in a non-vacuum state. In some embodiments, the innermost layer 115 can include reinforcing elements 150z or coils within the base material, as described above.

[0065]

[0087] The layer 113 above (i.e., radially outward of) the innermost layer 115 can be a slip layer.

[0066]

[0088] The layer 111 can be a radial gap (i.e., space). The gap layer 111 can provide a space for the braided layer above to move internally (when no vacuum is applied), and a space for the braided layer or fabric layer to move radially inward (when a vacuum is applied).

[0067]

[0089] The layer 109 can be a first braided layer that includes braided strands 133 similar to those described elsewhere in this specification. The braided layer can be, for example, from 0.00254 cm (0.001 inch) to 0.1016 cm (0.040 inch) thick. For example, the thickness of the braided layer can be 0.00254 cm (0.001 inch), 0.00762 cm (0.003 inch), 0.0127 cm (0.005 inch), 0.0254 cm (0.010 inch), 0.0381 cm (0.015 inch), 0.0508 cm (0.020 inch), 0.0635 cm (0.025 inch), or 0.0762 cm (0.030 inch).

[0068]

[0090] In some embodiments, as shown in FIG. 18B, the braid can have tension fibers or hoop fibers 137. The hoop fibers 137 can be helically wound and / or woven into the braided layer. Further, the hoop fibers 137 can be arranged in 2 to 50 hoops per inch, such as 20 to 40 hoops. The hoop fibers 137 can advantageously provide high compressive stiffness in the radial direction (to resist buckling or warping), but may remain flexible in the direction of the longitudinal axis 135 of the curing device 100. That is, when compression is applied to the curing device 100, the braided layer 109 will tend to expand in diameter as it is compressed. The hoop fibers 137 can resist this diametrical expansion and thus resist compression. Thus, the hoop fibers 137 can provide a system that is flexible in bending but still resists both tension and compression.

[0069]

[0091] Layer 107 may be another radial gap layer similar to layer 111.

[0070]

[0092] In some embodiments, the curing device described herein may have a plurality of braided layers. For example, the curing device may include 2, 3, or 4 braided layers. Referring to FIG. 18C, layer 105 may be a second braided layer 105. The second braided layer 105 may have any of the features described with respect to the first braided layer 109. In some embodiments, the braiding of the second braided layer 105 may be the same as the braiding of the first braided layer 109. In other embodiments, the braiding of the second braided layer 105 may be different from the braiding of the first braided layer 109. For example, the braiding of the second braided layer 105 may include fewer strands than the braiding of the first braided layer 109 and may have a larger braiding angle α. Having fewer strands can help increase the flexibility of the curing device 100 (compared to having a second strand with an equal or greater number of strands), and the larger braiding angle α can help contract the diameter of the first braided layer 109 while increasing / maintaining the flexibility of the curing device 100 (e.g., when the first braided layer is compressed). As another example, the braiding of the second braided layer 105 may include more strands than the braiding of the first braided layer 109 and may have a larger braiding angle α. Having more strands can result in a relatively strong and smooth layer, while having a larger braiding angle α can help contract the diameter of the first braided layer 109.

[0071]

[0093] Layer 103 may be another radial gap layer similar to layer 111. The gap layer 103 may have a thickness of from 0.000508 (0.0002) to 0.1016 cm (0.04 inches), such as about 0.0762 cm (0.03 inches). A thickness within this range can ensure that the strands 133 of the braided layer can easily slide and / or bulge relative to each other, ensuring the flexibility of the curing device 100 during bending.

[0072]

[0094] The outermost layer 101 can be configured to move radially inward when a vacuum is applied and pulled down against the braided layers 105, 109 and conforms to its surface. The outermost layer 101 can be soft and non-traumatic and can be sealed at both ends to create a vacuum-tight chamber having layer 115. The outermost layer 101 may be, for example, an elastomer made of urethane. The hardness of the outermost layer 101 may be, for example, from 30A to 80A. Further, the outermost layer 101 can have a thickness of from 0.000254 (0.0001) to 0.0254 cm (0.01 inch), such as about 0.00254 cm (0.001 inch), 0.00508 (0.002), 0.00762 cm (0.003 inch), 0.01016 cm (0.004 inch). Alternatively, the outermost layer may be a plastic including, for example, LDPE, nylon, or PEEK.

[0073]

[0095] In some embodiments, the outermost layer 101 may have, for example, tensile fibers or hoop fibers 137 extending therethrough. The hoop fibers 137 can be made of, for example, aramid (e.g., Technora, nylon, Kevlar), Vectran, Dyneema, carbon fiber, glass fiber, or plastic. Further, the hoop fibers 137 can be arranged in 2 to 50 hoops per inch, such as 20 to 40 hoops. In some embodiments, the hoop fibers 137 can be laminated within an elastomeric sheath. The hoop fibers can advantageously provide higher rigidity in one direction compared to the other (e.g., very rigid in the hoop direction but very compliant in the direction of the longitudinal axis of the curing device). Further, the hoop fibers can advantageously provide low hoop rigidity until the fibers are placed under tensile load, at which point the hoop fibers can exhibit a sudden high hoop rigidity.

[0074]

[0096] In some embodiments, the outermost layer 101 includes a lubricant, a coating, and / or a powder (e.g., talcum powder) on its outer surface, which can improve the sliding of the hardening device through the anatomical structure. The coating may be hydrophilic (e.g., Hydromer® coating or Surmodics® coating) or hydrophobic (e.g., fluoropolymer). The coating can be applied, for example, by dipping, painting, or spraying the coating thereon.

[0075]

[0097] Similarly, the innermost layer 115 may include a lubricant, a coating (e.g., hydrophilic or hydrophobic coating), and / or a powder (e.g., talcum powder) on its inner surface configured such that the boundary layers can shear more easily relative to each other, particularly when a vacuum is not applied to the hardening device 100.

[0076]

[0098] In some embodiments, the outermost layer 101 may be loose on the radially inner layer. For example, the inner diameter of layer 101 (assuming it forms a tube) may have a diameter gap of 0 cm (0 inches) to 0.508 cm (0.200 inches) where the next layer is radially inner (e.g., has a braided layer). This can improve the flexibility of the vacuum hardening system when not under vacuum while still maintaining a high stiffening ratio. In other embodiments, the outermost layer 101 may be stretched somewhat over the next radially inner layer (e.g., a braided layer). For example, the zero-strain diameter of the tube forming layer 101 may be 0 (0) to 0.508 cm (0.200 inches) smaller in diameter than the next radially inner layer and may be stretched thereover. When not under vacuum, this system may be less flexible than a system where the outer layer 101 is looser. However, it may have a smoother appearance and be less likely to tear during use.

[0077]

[0099] In some embodiments, the outermost layer 101 may be loose over the radially inner layer. A small positive pressure can be applied under the layer 101 to gently expand the layer 101 and allow the hardening device to bend more freely with a flexible configuration. In this embodiment, the outermost layer 101 can be an elastomer and can maintain a compressive force on the entire braid, thereby providing rigidity. When a positive pressure is supplied (nominal, sufficient to expand the sheath from the braid, e.g., 13.79 kPa (2 psi)), the outermost layer 101 no longer contributes to rigidity and can enhance the baseline flexibility. If hardening is required, the positive pressure can be replaced with a negative pressure (vacuum) to achieve rigidity.

[0078]

[0100] The inside of the hardening device 100 can be evacuated from minimum to maximum atmospheric pressure (e.g., about 101.4 kPa (14.7 psi)). In some embodiments, a bleed valve, regulator, or pump control can be provided to lower the vacuum to any intermediate level to provide a variable stiffness capability. The vacuum pressure can be advantageously used to rigidize the hardening device structure by compressing the layers of the braided sleeve against adjacent layers. The braid is naturally flexible to bending (i.e., when bent perpendicular to its longitudinal axis), and as the sleeve is bent so that it conforms to the bent shape while the braid lies on the inner layer, the lattice structure formed by the interwoven strands is distorted. This results in a lattice shape where the angle of the corners of each lattice element changes as the braided sleeve bends. When compressed between conformal materials such as the layers described herein, the lattice elements are locked at their current angles and their ability to resist deformation when a vacuum is applied is improved, thereby causing the entire structure to bend and harden when the vacuum is applied. Further, in some embodiments, hoop fibers passing through or covering the braid can carry a tensile load that helps prevent local buckling of the braid under the applied high bending load.

[0079]

[0101] The rigidity of the hardening device 100 can increase from 2 times to more than 30 times, for example 10 times, 15 times, or 20 times when transitioning from a flexible configuration to a rigid configuration. In one specific example, the rigidity of a hardening device similar to the hardening device 100 was tested. The wall thickness of the test hardening device was 1.0 mm and the outer diameter was 17 mm. A force was applied to the end of the 9.5 cm long cantilever portion of the hardening device until the hardening device deflected 10 degrees. The force required in the flexible mode was only 30 grams, while the force required in the rigid (vacuum) mode was 350 grams.

[0080]

[0102] In some embodiments of the vacuum hardening device 100, only one braided layer can be present. In other embodiments of the vacuum hardening device 100, there may be two, three, or more braided layers. In some embodiments, one or more of the radial gap layers or slip layers of the hardening device 100 can be removed. In some embodiments, a part or all of the slip layer of the hardening device 100 can be removed.

[0081]

[0103] The braided layer described herein can function as a variable rigidity layer. The variable rigidity layer may include one or more variable rigidity elements or structures that increase the bending rigidity and / or shear resistance and result in a higher rigidity when activated (e.g., when a vacuum is applied). In addition to or instead of the braided layer, other variable rigidity elements can be used. In some embodiments, the engagor can be used as a variable rigidity element as described in International Patent Application No. PCT / US2018 / 042946 entitled "DYNAMICALLY RIGIDIZING OVERTUBE" filed on July 19, 2018, which is hereby incorporated by reference in its entirety. Alternatively or additionally, the variable rigidity element can include particles or granules, a jamming layer, a scale, a hardened axial member, a rigidizer, a longitudinal member, or a substantially longitudinal member.

[0082]

[0104] In some embodiments, the curing device described herein can be cured by applying pressure rather than a vacuum. For example, referring to FIGS. 19A - 19B, the curing device 2100 can be made similar to the curing device 100, except that it is configured to hold pressure (e.g., greater than 1 atm) inside for curing instead of a vacuum. Thus, the curing device 2100 can include a plurality of layers disposed around the lumen 2120 (e.g., for disposing an instrument or endoscope through the lumen). The curing device 2100 can include an innermost layer 2115 (similar to the innermost layer 115), a slip layer 2113 (similar to the slip 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 described herein, a gap layer 2107 (similar to layer 107), and an outermost containment layer 2101.

[0083]

[0105] The pressure gap 2112 may be a sealed chamber that provides a gap for applying pressure to the layers of the curing device 2100. The pressure can be supplied to the pressure gap 2112 using an expanding / pressurizing medium of a fluid or gas. The expanding / pressurizing medium may be water or saline, or a lubricating fluid such as, for example, clay or glycerin. The lubricating fluid can, for example, help the layers of the curing device 2100 flow past each other in a flexible configuration. The expanding / pressurizing medium can be supplied to the gap 2112 during curing of the curing device 2100 and can be partially or fully drained therefrom to deform the curing device 2100 back to a flexible configuration. In some embodiments, the pressure gap 2112 of the curing device 2100 can be connected to a filled pressure source such as a filled syringe or a filled inhaler, thereby shortening the required setup time for the physician.

[0084]

[0106] The bladder layer 2121 can be made of, for example, an elastomer with a low durometer (e.g., from Shore 20A to 70A) or a thin plastic sheet. The bladder layer 2121 can be formed from a thin sheet of plastic or rubber that is sealed longitudinally to form a tube. The longitudinal seal can be, for example, a butted or lap joint. For example, the lap joint can be formed longitudinally on the rubber sheet by melting the rubber at the lap joint or by using an adhesive. In some embodiments, the bladder layer 2121 can have a thickness of from 0.000508 cm (0.0002 inches) to 0.0508 cm (0.020 inches), such as a thickness of about 0.127 cm (0.005 inches). The bladder layer 2121 is soft, has high friction, is stretchable, and / or is prone to wrinkling. In some embodiments, the bladder layer 2121 is a polyolefin or PET. The bladder 2121 can be formed, for example, using methods used to form heat shrinkable tubes, such as extrusion of a substrate followed by thinning of the walls by heat, pressure, and / or radiation. When pressure is supplied through the pressure gap 2112, the bladder layer 2121 can expand through the gap layer 2111 and press the braided layer 2109 against the outermost containment layer 2101 so as to reduce the relative movement of the braided strands.

[0085]

[0107] The outermost containment layer 2101 may be a tube such as an extrusion tube. Alternatively, the outermost containment layer 2101 may be a tube in which a reinforcing member (e.g., a metal wire including a circular or rectangular cross-section) is encapsulated within an elastomeric matrix, similar to that described for the innermost layer of other embodiments described herein. In some embodiments, the outermost containment layer 2101 may include a helical spring (e.g., made of circular or flat wire), and / or a tubular braid (such as one made of circular or flat metal wire), and a thin elastomeric sheet that is not bonded to other elements within the layer. The outermost containment layer 2101 may be a tubular structure having a continuous smooth surface. This may facilitate sliding of the outer member in proximity with a locally high contact load (e.g., the nested structure further described herein). Additionally, the outer layer 2101 may be configured to support a compressive load such as clamping. Further, the outer layer 2101 (e.g., having a reinforcing element therein) may be configured such that the curing device 2100 does not change diameter even when pressure is applied.

[0086]

[0108] Since both the outer layer 2101 and the inner layer 2115 include a reinforcing element therein, the braided layer 2109 can be reasonably restricted from both diameter shrinkage (under tensile load) and diameter increase (under compressive load).

[0087]

[0109] Instead of using a vacuum, the rigidity of the curing device 2100 can be increased by transitioning from a flexible state to a rigid state using pressure. For example, in some embodiments, the pressure supplied to the pressure gap 2112 can be between 1 and 40 atmospheres, such as between 2 and 40 atmospheres, between 4 and 20 atmospheres, between 5 and 10 atmospheres, etc. In some embodiments, the supplied pressure is about 2 atmospheres, about 4 atmospheres, about 5 atmospheres, about 10 atmospheres, about 20 atmospheres. In some embodiments, the curing device 2100 can exhibit a change of 2 to 100 times, such as 10 to 80 times, 20 to 50 times, etc., in the relative flexural rigidity (when measured in a simple cantilever configuration) from a flexible configuration to a rigid configuration. For example, the curing device 2100 can have a change in relative flexural rigidity from a flexible configuration to a rigid configuration of about 10, 15, 20, or 25, 30, 40, 50, or 100 times or more. FIG. 20 shows a graph of the flexural strength versus pressure of the curing device described herein. As shown, the flexural strength of the curing device increases as the pressure supplied to the wall increases.

[0088]

[0110] Advantageously, the inner layer having the sublayer and / or overlapping reinforcing elements described herein is flexible but can withstand high pressures (e.g., the pressure acting on the outer diameter of the inner layer could otherwise crush the tube). Further, the inner layer having the sublayer and / or overlapping reinforcing elements described herein can advantageously provide improved torque support capabilities or torsional rigidity.

[0089]

[0111] It should be understood that any feature described herein with respect to one embodiment can be combined with or used in place of any feature described herein with respect to another embodiment. For example, the various layers and / or features of the curing device described herein can be combined, substituted, and / or rearranged with respect to other layers.

[0090]

[0112] Additional details related to the present invention, including materials and manufacturing techniques, can be used within the level of those skilled in the relevant art. The same may apply to the method-based aspects of the present invention with respect to additional acts that are commonly or logically employed. It is also contemplated that any feature of the described variations of the present invention can be described and claimed independently or in combination with any one or more of the features described herein. Similarly, references to a single item include the possibility that there may be a plurality of the same items. More specifically, the singular forms "a", "and", "said", and "the" as used in this specification and the appended claims include plural referents unless the context clearly dictates otherwise. It should further be noted that claims can be made to exclude any element. Therefore, this description is intended to serve as a precondition for the use of exclusive terms such as "alone", "only", etc. in relation to the description of claim elements or the use of "negative" limitations. Unless defined otherwise herein, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the technical field to which the present invention pertains. The scope of the present invention should not be limited by this specification but should be limited only by the plain meaning of the terms of the appended claims used.

[0091]

[0113] When a feature or element is referred to as being "above" another feature or element in this specification, it may be directly above the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly above" another feature or element, no intervening features or elements are present. Also, when a feature or element is referred to as being "connected to", "attached to", or "coupled to" another feature or element, it is understood that it can be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected to", "directly attached to", or "directly coupled to" another feature or element, no intervening features or elements are present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated can be applied to other embodiments. Also, it will be understood by those skilled in the art that a reference to a structure or feature being "adjacent" to another feature may have a portion that overlaps or is below the adjacent feature.

[0092]

[0114] The terms used in this specification are for the purpose of describing particular embodiments only and are not intended to limit the invention. For example, as used in this specification, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used in this specification, the terms "comprises" and / or "comprising" identify the presence of the recited features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used in this specification, the term "and / or" includes any and all combinations of one or more of the associated listed items and can be abbreviated as " / ".

[0093]

[0115] Spatially relative terms such as "under", "below", "lower", "over", "upper", etc. may be used herein for ease of description to explain the relationship of one element or feature shown in the figures to another element or feature. It will be understood that spatially relative terms are intended to encompass various orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as "under" or "beneath" another element or feature will be oriented "over" the other element or feature. Thus, the exemplary term "under" can encompass both upward and downward directions. The device can be in another orientation (rotated 90 degrees or other orientation), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upwardly", "downwardly", "vertically", "horizontally", etc. are used herein for descriptive purposes only unless otherwise indicated.

[0094]

[0116] The terms "first" and "second" may be used herein to describe various features / elements, but these features / elements should not be limited by these terms unless otherwise indicated in the context. These terms can be used to distinguish one feature / element from another. Thus, without departing from the teachings of the present invention, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element.

[0095]

[0117] As used in this specification and the claims, all numbers, including those used in the examples, unless specifically indicated otherwise, can be read as if the term "about" or "approximately" preceded the number, even if the term does not explicitly appear. The phrases "about" or "approximately" may be used when describing size and / or position to indicate that the described value and / or position is within a reasonable expectation range of the value and / or position. For example, a numerical value can have a value of + / -0.1% of the specified value (or range of values), + / -1% of the recited value (or range of values), + / -2% of the recited value (or range of values), + / -5% of the recited value (or range of values), + / -10% of the recited value (or range of values), and so on. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.

Claims

1. A curing device comprising: An elongate flexible tube including a first reinforcing element and a second reinforcing element, wherein the second reinforcing element is wound in a reverse direction with respect to the first reinforcing element; A curing layer disposed radially outside the elongate flexible tube; An outer layer covering the elongate flexible tube and the curing layer; An inlet for vacuum or pressure between the elongate flexible tube and the outer layer, configured to be attached to a vacuum or pressure source; And comprising The curing device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet. The curing device further comprises a bonding layer between the first reinforcing element and the second reinforcing element. The bonding layer includes an adhesive. A curing device.

2. The curing device according to claim 1, wherein the curing layer is a braided layer.

3. The curing device according to claim 1, wherein the first and second reinforcing elements are embedded in a base material, and the bonding layer includes the same material as the base material.

4. The curing device according to claim 1, wherein the first reinforcing element is wound at an angle in a positive direction and the second reinforcing element is wound at the same angle in a negative direction.

5. The curing 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 with respect to the longitudinal axis of the curing device.

6. The curing device according to claim 1, wherein the first reinforcing element is disposed radially outside the second reinforcing element.

7. The curing device according to claim 6, further comprising a separation layer between the first reinforcing element and the second reinforcing element.

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

9. A curing device comprising: An elongate flexible tube including a first sub-layer and a second sub-layer, wherein the first sub-layer includes a first reinforcing element forming a first helix around the longitudinal axis of the curing device, the second sub-layer includes a second reinforcing element forming a second helix around the longitudinal axis, and the second helix is disposed over the space between the turns of the first helix; A curing layer disposed radially outside the elongate flexible tube; An outer layer covering the elongated flexible tube and the cured layer, A vacuum or pressure inlet between the elongated flexible tube and the outer layer, configured to be attached to a vacuum or pressure source, Comprising, The curing device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet, The first reinforcing element is wound in the same direction and at the same pitch as the second reinforcing element, Curing device. **Claim 10** The curing device according to claim 9, wherein the cured layer is a braided layer. **Claim 11** The curing device according to claim 9, further comprising a bonding layer between the first sublayer and the second sublayer. **Claim 12** The curing device according to claim 11, wherein the bonding layer contains an adhesive. **Claim 13** The curing device according to claim 11, wherein the first and second reinforcing elements are embedded in a base material, and the bonding layer contains the same material as the base material. **Claim 14** The curing 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 with respect to the longitudinal axis of the curing device. **Claim 15** The curing device according to claim 9, wherein the second reinforcing element radially overlaps at least a part of the first reinforcing element. **Claim 16** The curing device according to claim 9, wherein the second reinforcing element has a width that is 1.5 to 4 times the width of the space between the first spirals. **Claim 17** The curing device according to claim 9, wherein the second reinforcing element has a width smaller than the width of the first reinforcing element. **Claim 18** A curing device, An elongated flexible tube including a reinforcing element wound spirally around the longitudinal axis of the device, with adjacent turns of the spiral overlapping radially, A cured layer disposed radially outside the elongated flexible tube, An outer layer covering the elongated flexible tube and the cured layer, A vacuum or pressure inlet between the elongated flexible tube and the outer layer, configured to be attached to a vacuum or pressure source, Comprising, The curing device is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet, The inner part of the reinforcing element overlaps with the stepped part on the outer side of the adjacent reinforcing element. Hardening device.

19. The hardening device according to claim 18, wherein the hardening layer is a braided layer.

20. The hardening device according to claim 18, wherein the reinforcing element is embedded in the base material.

Images