Systems and methods for varying flexural stiffness of flexible elongate devices

Abstract

A flexible elongate device includes an articulatable distal section and a non-articulatable proximal section. The non-articulatable proximal section is proximal to the articulatable distal section. A distal portion of the non-articulating proximal section has a first bending stiffness and a proximal portion of the non-articulating proximal section has a second bending stiffness. The first bending stiffness is less than the second bending stiffness.

Description

[0001] Cross-reference application

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 407,899, filed on September 19, 2022, entitled “Systems and Methods for Varying Bending Stiffness of a Flexible Elongate Device,” and also claims priority to and the benefit of U.S. Provisional Application No. 63 / 407,941, filed on September 19, 2022, entitled “Systems and Methods for Varying Bending Stiffness of a Flexible Elongate Device,” the entire contents of both applications being incorporated herein by reference. Technical Field

[0003] The examples described herein relate to systems and methods for changing the bending stiffness of a flexible elongated device. Specifically, the examples described herein relate to systems and methods for changing the band width of a winding / coil of a flexible elongated device and / or combining the layers of the flexible elongated device to change the bending stiffness of the flexible elongated device. Background Art

[0004] Minimally invasive medical techniques are intended to reduce the amount of tissue damaged during a medical procedure, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques can be performed through natural orifices in the patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, an operator can insert minimally invasive medical tools to reach the target tissue location. Minimally invasive medical tools include instruments such as therapeutic instruments, diagnostic instruments, biopsy instruments, and surgical instruments, as well as flexible, elongated devices with cavities that accommodate these instruments and pass through anatomical passages to guide these instruments to the target tissue location. Summary of the invention

[0005] Various features may allow a flexible elongated device, such as a catheter, to have variable bending stiffness along its length.The following presents a summary of various examples described herein and is not intended to identify key or critical elements or to delineate the scope of the claims.

[0006] In accordance with some examples, a flexible elongated device is provided. The flexible elongated device includes an articulable distal segment and a non-articulable proximal segment, the non-articulable proximal segment being proximal to the articulable distal segment. A distal portion of the non-articulable proximal segment has a first bending stiffness, and a proximal portion of the non-articulable proximal segment has a second bending stiffness. The first bending stiffness is less than the second bending stiffness.

[0007] In accordance with other examples, a flexible elongated device is provided. The flexible elongated device includes a winding layer, the winding layer providing the flexible elongated device with a variable bending stiffness along the axial length of the winding layer. The winding layer includes a plurality of windings, and the plurality of windings includes a first winding, the first winding including a band element having a variable band width. In a first region along the axial length of the winding layer having a first bending stiffness, a first band element of the first winding has a first band width. In a second region along the axial length of the winding layer having a second bending stiffness, the second bending stiffness is higher than the first bending stiffness. A second band element of the first winding has a second band width wider than the first band width.

[0008] In accordance with other examples, a flexible elongated device is provided. The flexible elongated device includes a winding layer, the winding layer providing the flexible elongated device with a variable bending stiffness along the axial length of the winding layer. The winding layer includes a plurality of windings, and the plurality of windings includes a first winding, the first winding including a belt element having a variable belt width. In a first region having a first bending stiffness along the axial length of the winding layer, the first belt element of the first winding has a first belt width. In a second region having a second bending stiffness along the axial length of the winding layer, the second bending stiffness is higher than the first bending stiffness. The second belt element of the first winding has a second belt width wider than the first belt width. The plurality of windings further includes a second winding and a third winding. Adjacent windings in the plurality of windings have opposite pitch directions.

[0009] Consistent with other examples, a flexible, elongated device is provided. The flexible, elongated device includes a winding layer, the winding layer providing the flexible, elongated device with a variable bending stiffness along the axial length of the winding layer. The winding layer includes: an outer winding; an inner winding, which is inside the outer winding; and a junction, which is between the inner winding and the outer winding, coupling the inner winding and the outer winding to each other. In a first region along the axial length of the winding layer having a first bending stiffness, a first subset of the junctions has a first spatial density. In a second region along the axial length of the winding layer having a second bending stiffness, the second bending stiffness is higher than the first bending stiffness, and a second subset of the junctions has a second spatial density higher than the first spatial density.

[0010] Consistent with other examples, a method is provided. The method includes constructing a first winding and a second winding. The first winding includes a tape element having a variable tape width. The method further includes constructing a winding layer using the first winding and the second winding and bonding the first winding to the second winding. In a first region having a first bending stiffness along an axial length of the winding layer, the first tape element of the first winding has a first tape width, and in a second region having a second bending stiffness along the axial length of the winding layer, the second bending stiffness is higher than the first bending stiffness. The second tape element of the first winding has a second tape width that is wider than the first tape width.

[0011] Consistent with other examples, a method is provided. The method includes positioning a winding layer of a flexible elongated device around a conductive mandrel. The winding layer includes an outer winding and an inner winding within the outer winding. The method further includes guiding the winding layer between a plurality of conductive wheels. The conductive wheels are configured to contact the winding layer. The method further includes welding the outer winding to the inner winding at a plurality of welding locations by applying an electric current between the mandrel and the conductive wheels. In a first region along an axial length of the winding layer having a first bending stiffness, a first subset of welding locations in the plurality of welding locations has a first spatial density. In a second region along the axial length of the winding layer having a second bending stiffness, the second bending stiffness being higher than the first bending stiffness, a second subset of welding locations in the plurality of welding locations has a second spatial density that is higher than the first spatial density.

[0012] Other examples include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of any one or more of the methods described below.

[0013] It should be understood that the foregoing general description and the following detailed description are illustrative and explanatory in nature, and are intended to provide an understanding of the various examples described herein without limiting the scope of the various examples described herein. In this regard, additional aspects, features and advantages of the various examples described herein will be apparent to those skilled in the art through the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1A is a cross-sectional front view of a flexible, elongated device including a wound layer according to some examples.

[0015] Figure 1B Based on some examples Figure 1A A cross-sectional side view of the flexible elongated device is shown.

[0016] Figure 2A is a side view of an outer coil, a middle coil, and an inner coil of a coil layer of a flexible elongated device according to some examples.

[0017] Figure 2B Based on some examples Figure 2A A side view of an inner coil is shown having a variable tape width along the length of the coiled layer of the flexible elongated device.

[0018] Figure 3 is a side view of a flexible, elongated device having a non-articulatable proximal section and an articulatable distal section, according to some examples.

[0019] Figure 4 A portion of a coiled layer of a flexible elongated device is shown according to some examples.

[0020] Figure 5A and Figure 5B A portion of a coiled layer of a flexible elongated device having various coiled configurations is shown according to some examples.

[0021] Figure 6 is a flow chart illustrating a method of manufacturing a wound layer of a flexible elongated device according to some examples.

[0022] Fig. 7A is a side view of a wound layer of a flexible elongated device having axially variably spaced bonding locations according to some examples.

[0023] Figure 7B is a side view of outer and inner windings of a winding layer of a flexible elongated device having axially variably spaced bonding locations according to some examples.

[0024] Figure 7C is a side view of a distal portion of a coiled layer of a flexible elongated device having axially variable spaced bonding locations according to some examples.

[0025] Fig.7D is a cross-sectional front view of a wound layer of a flexible elongated device having radially variably spaced bonding locations according to some examples.

[0026] Figure 8 is a side view of a flexible, elongated device having a non-articulatable proximal section and an articulatable distal section, according to some examples.

[0027] Figure 9A-9C Distal portions of coiled layers of a flexible, elongated device having various coil winding patterns are shown according to some examples.

[0028] Fig.10 A welding mechanism for a flexible elongated device according to some examples is shown.

[0029] Fig.11 is a flow chart illustrating a method of welding wound layers of a flexible elongated device, according to some examples.

[0030] Fig.12 is a schematic diagram of a remotely operated medical system according to some examples.

[0031] Fig.13 is a schematic diagram of a medical device system according to some examples.

[0032] The various examples described herein and their advantages are described in the detailed description below.It should be understood that for purposes of illustration and not limitation of the various examples described herein, like reference numerals are used to identify like elements shown in one or more of the drawings. DETAILED DESCRIPTION

[0033] The present disclosure describes flexible elongated devices that can be used, for example, in medical systems to provide variable bending stiffness along the length of the flexible elongated device. Examples of flexible elongated devices may include catheters, medical devices, sheaths, or any other type of device that includes a flexible elongated body. Fig.12 and showing the medical device system 200 Fig.13 Examples of medical systems are provided that may incorporate any of the flexible, elongated devices described herein.

[0034] A flexible elongated device (such as a catheter, an instrument, a sheath, or any other flexible elongated body) may have a variable bending stiffness along the axial length of the flexible elongated device. The flexible elongated device includes a winding layer that can assist in maintaining the patency of the cavity (and any other cavity) of the flexible elongated device during the joint movement and navigation of the flexible elongated device. The winding layer can also provide flexibility to the flexible elongated device while achieving a variable bending stiffness of the flexible elongated device. For example, the winding layer includes a variable band to provide a greater bending stiffness in one area relative to another area, thereby achieving a change in bending stiffness along the length of the axis. The winding layer can also provide structural support for the flexible elongated device. The winding layer can include at least two layers of windings, such as three layers of windings in one example. Each winding can include a band element that forms a winding structure. The band element of at least one of the windings can have a variable band width along the axial length of the winding layer to provide a variable bending stiffness. Generally speaking, a region with a larger band width in the winding has a higher bending stiffness, while a region with a smaller band width in the winding has a lower bending stiffness. One or more other windings of the wound layer may have a tape element having a uniform tape width along the axial length of the wound layer.

[0035] Additionally or alternatively, the windings may be joined together at selected, variably spaced locations along the axial length of the winding layer. Variable spacing joints allow the flexible elongated device to have a variable bending stiffness, which can be adjusted to a customized bending stiffness profile by customizing the location of the winding layer joints. The bending stiffness can vary along the axial length of the winding layer, for example, when the joints are in a bonding position with a variable spacing along the axial length of the winding layer. When the joints are in a bonding position with a variable spacing around the circumference of the winding layer, the bending stiffness of the flexible elongated device can vary around the radial length of the winding layer. Customizing the bending stiffness profile of the flexible elongated device can avoid the flexible elongated device from bending to or beyond the maximum bending stiffness. This can extend the life of the flexible elongated device and can cause the flexible elongated device to be more responsive to motion commands during medical procedures. Additionally, customizing the bending stiffness profile for the flexible elongated device can allow the bending stiffness of the flexible elongated device to be adjusted to achieve more optimized performance as a bendable flexible elongated device, where the performance depends on the bending stiffness parameters of the flexible elongated device.

[0036] In one example, the winding layer includes three windings. Adjacent windings of the winding layer have opposite pitch directions. One winding of the winding layer, such as the inner winding of the winding layer, includes a belt element with a variable belt width along the axial length of the winding layer. The outer winding and the middle winding are both closed pitch. The inner winding is open pitch. The three windings are combined (e.g., welded) at the proximal end and distal end of the winding layer. The three windings are all made of stainless steel, but can also be made of other metals or plastic materials suitable for winding instead.

[0037] In some examples, one of the windings of the winding layer may have a belt element with a variable belt width. This allows the flexible elongated device to have high bidirectional torsional stiffness and high axial stiffness in both compression and tension. Since the winding layer has a variable belt width, changing the bending stiffness of the flexible elongated device can avoid the flexible elongated device from being damaged by bending to the maximum bending stiffness, bending beyond the maximum bending stiffness, or bending to a small radius or bending beyond the minimum bending radius. This can extend the life of the flexible elongated device and can cause the flexible elongated device to react more quickly to motion commands during medical procedures. Making the winding have a variable belt width can allow the flexible elongated device to resist out-of-round, kink and plastic deformation while maintaining a thin wall, which can reduce the total outer diameter of the flexible elongated device. In some examples, the winding layer includes multiple layers of windings (e.g., three layers of windings). A winding layer with multiple layers of windings (e.g., three layers of windings) can have a higher torsional stiffness and axial stiffness than a winding layer with fewer winding layers (e.g., one or two layers of windings).

[0038] Figure 1A and Figure 1B A cross-sectional front view and a cross-sectional side view of a flexible elongated device 150 (also referred to as "elongated device 150") are shown, respectively. The elongated device 150 may include a multi-layer, hollow cylindrical tube defining a cavity 155. The elongated device 150 may include one or more articulatable segments and one or more non-articulatable segments. In one example, the elongated device 150 includes an articulatable distal segment and a non-articulatable proximal segment proximal to the articulatable distal segment. Figure 1A and Figure 1B, a non-articulation section is shown. The elongated device 150 may include an outer sheath 160, a support layer 165, a winding layer 170, and an inner sheath 175 at the non-articulation section, each of which is concentrically and coaxially arranged around the cavity 155. In some examples, the cavity 155 is a working cavity that is sized to receive one or more devices, such as tools (e.g., ablation probes, biopsy needles, etc.), sensors (e.g., visual probes, ultrasound probes, etc.), or other flexible elongated devices that can be articulated (e.g., catheters). In some examples, a catheter (not shown) that can define the cavity 155 is within the inner sheath 175. In some examples, the elongated device 150 may include multiple cavities (e.g., within the inner sheath 175).

[0039] The outer sheath 160 may include a section of flexible tubing extending from an inner surface to an outer surface. The outer sheath 160 may provide protection for components further inside the elongated device 150 and may assist in maintaining the patency of the lumen 155 (and any other lumens) during articulation or navigation of the elongated device 150. The outer sheath 160 may be a metallic material, a polymeric material, a composite material, or any other suitable material.

[0040] The support layer 165 may include an embedded support member 166 that assists in maintaining the patency of the cavity 155 (and any other cavity) during articulation or navigation of the elongated device 150. The support layer 165 may be a metallic material, a polymeric material, a composite material, or any other suitable material. In some examples, the support member 166 is a tubular braided element, such as, as a non-limiting example, a polyimide braid. The support member 166 may resist radial expansion and / or increase torsional stiffness. The support member 166 is sandwiched within the support layer 165, which may be made of two separately extruded sections of flexible tubing that may be bonded to each other and / or to the support member 166. Other examples may lack the support layer 165 and / or the support member 166.

[0041] The winding layer 170 can assist in maintaining the patency of the cavity (e.g., cavity 155 and any other cavity) during the articulation or navigation of the elongated device 150. The winding layer 170 can also provide flexibility to the elongated device 150 while achieving a change in bending stiffness along the length of the elongated device 150. Additionally, the winding layer 170 can provide structural support for the elongated device 150. For example, the winding layer 310 can provide high bidirectional torsional stiffness and high axial stiffness to resist twisting or rotational forces in compression and extension. In some examples, the winding layer 170 includes a plurality of concentric windings, each of which includes a belt element. The belt element of at least one of the windings can have a variable belt width, providing the elongated device 150 with variable bending stiffness. The belt element of each winding can have an open pitch or a closed pitch. In other examples, the winding layer 170 includes a woven element or a braided element. The winding layer 170 can provide the elongated device 150 with high bidirectional torsional stiffness and high axial stiffness (in compression and extension). Other examples may include any number or arrangement of support layers and / or coiled layers between the outer sheath 160 and the inner sheath 175. In some embodiments, the articulated section(s) of the elongated device 150 may include a coiled layer 170. Additional details regarding the coiled layer 170 will be described below in conjunction with Figure 2A-Figure 5B Have a discussion.

[0042] The inner sheath 175 may include a section of flexible tubing extending from the inner surface to the outer surface, such as to define a certain wall thickness. The inner sheath 175 may be a metal material, a polymer material, a composite material or any other suitable material. The inner sheath 175 may include a catheter 180 (e.g., four catheters), which is configured to transport one or more control elements, such as a pull wire 185. The pull wire 185 can be used to control the joint movement of the articulated section of the elongated device 150. The pull wire 185 at the articulated section is not surrounded by the catheter 188 to allow the tension of the pull wire 185 to change the articulated section. In some examples, the catheter 180 includes a cylindrical winding or coil, for example, formed by a narrow material band. The coiled nature of this catheter allows it to bend and twist under the action of tension, compression and other forces while maintaining the patency of the channel through which the control element extends. Each conduit 180 can extend within a preformed channel through the inner sheath 175, or can be embedded in the inner sheath 175 when the inner sheath 175 is extruded around the conduit 180. The conduits 180 can be arranged symmetrically around the inner sheath 175. In other examples, the inner sheath 175 can include any number, type, and arrangement of conduits 180 depending on the application and structure of the elongated device 150.

[0043] The pull wires 185 are coaxially disposed within respective catheters 180. In some examples, the catheters 180 are configured to maintain the patency or openness of the lumen 155 and minimize friction so that the pull wires 185 can slide or float freely within the catheters 180. In some examples, the catheters 180 are configured to maintain radial spacing or positioning of the pull wires 185 along the length of the elongated device 150.

[0044] Figure 2A A side view of a coiled layer 310 (e.g., coiled layer 170) of an exemplary flexible elongated device (e.g., flexible elongated device 150) is shown. Coiled layer 310 provides variable bending stiffness to elongated device 150 along its length by including coils of one or more ribbon elements having variable ribbon widths.

[0045] The winding layer 310 may include multiple layers of windings. In some examples, the winding layer 310 may include three layers of windings, such as an outer winding 312, an intermediate winding 314, and an inner winding 316. The outer winding 312, the intermediate winding 314, and the inner winding 316 may be concentric around the longitudinal axis A of the winding layer 310. In some examples, the outer winding 312 defines a cavity, and the intermediate winding 314 may extend within the cavity. The intermediate winding 314 may define a cavity, and the inner winding 316 may extend within the cavity of the intermediate winding 314. In some examples, the winding layer 310 includes more than three windings (e.g., four windings, five windings, etc.). In some examples, the winding layer 310 includes two windings, such as an inner winding 316 and an outer winding. One, some, or all of the outer winding 312, the intermediate winding 314, and the inner winding 316 may have a circular cross-section, a hexagonal cross-section, an octagonal cross-section, or a cross-section of some other shape. Each of the windings of the winding layer 310 provides kink resistance and the winding achieves its kink resistance and structural support.

[0046] The coiled layer 310 further includes a proximal portion 318 and a distal portion 320. The proximal portion 318 may be adjacent to or closer to the drive unit 204 of the medical device system 200 (see Fig.13 The distal portion 320 is distal to the proximal portion 318 and may be located at or adjacent to the distal end 218 of the elongated device 202 of the medical device system or the distal end 221 of the non-articulable section 205 of the elongated device 202 (see Fig.13 ).

[0047] Different windings of the winding layer 310 may include tape elements of different tape widths. The outer winding 312 includes a tape element 313. The middle winding 314 includes a tape element 315. The inner winding 316 includes a tape element 317. In some examples, the tape element 313 of the outer winding 312 has a tape width W1. Alternatively, the tape element 313 may have different tape widths along the length of the outer winding 312. The tape width of the tape element 313 may vary along the length of the outer winding 312 in any arrangement or pattern. In some examples, the tape element 315 of the middle winding 314 has a tape width W2. Alternatively, the tape element 315 may have different tape widths along the length of the middle winding 314. The tape width of the tape element 315 may vary along the length of the middle winding 314 in any arrangement or pattern. In some examples, the tape width W2 of the tape element 315 is the same as the tape width W1 of the tape element 313. In some examples, the tape element 317 of the inner winding 316 has a tape width that can vary along the length of the inner winding 316, such as Figure 2B In some examples, at least one of the windings of winding layer 310 (e.g., a winding without a variable band width) can be a braided winding formed by at least two woven strands. The braided winding provides high torsional stiffness to winding layer 310, and therefore to elongated device 150.

[0048] exist Figure 2A In an example of the embodiment of the present invention, the tape elements 317 of the inner winding 316 have a variable tape width along the length of the winding layer 310. However, in alternative examples, the tape elements 313 of the outer winding 312 and / or the tape elements 315 of the middle winding 314 may additionally or alternatively have a variable tape width along the length of the winding layer 310. In such alternative examples, the tape elements 317 of the inner winding 316 may have a variable tape width or a constant tape width. In some examples, the outer winding 312 has a greater impact on the bending stiffness of the winding layer 310 than the middle winding 314 and the inner winding 316. In examples when the tape elements 313 of the outer winding 312 have a variable tape width, the winding layer 310 may have a greater range of possible bending stiffness values ​​than when the tape elements 315 of the middle winding 314 have a variable tape width or when the tape elements 317 of the inner winding 316 have a variable tape width. In some examples, when the ribbon element 317 of the inner coil 316 has a constant ribbon width, the inner surface of the inner coil 316 can be smoother than when the ribbon element 317 has a variable ribbon width. The smooth inner surface of the inner coil 316 can provide a smooth path for tools, fluids, or other objects as they extend through the lumen of the inner coil 316. The constant width ribbon element is most likely made from a flat wire material and coiled into a spiral diameter and pitch required for the medical device. The variable pitch ribbon element is most likely manufactured by laser cutting a variable ribbon width spiral into a cylindrical tube. However, both types of ribbon elements can be produced using a manufacturing process or an equivalent process.

[0049] Figure 2B A side view of an inner winding 316 of a winding layer 310 is shown. The tape width of the tape element 317 of the inner winding 316 can vary along the length of the winding layer 310 to allow the elongated device 150 to have a variable bending stiffness. A wider tape width at a certain area of ​​the winding layer 310 corresponds to a higher bending stiffness at that area of ​​the winding layer 310. Similarly, a narrower tape width corresponds to a lower bending stiffness. Thus, the tape width of the tape element 317 can be sized to achieve different bending stiffness distributions along the axial length of the elongated device 150.

[0050] In some examples, the inner coil 316 may include different regions 330, 340, and 350 along its axial length having different bending stiffnesses. Region 330 is the most distal region. Region 340 is proximal to region 330 and distal to region 350. Region 350 is the most proximal region. Figure 2B The arrangement and number of regions shown is one example. The inner winding 316 may include any other arrangement and / or number of regions.

[0051] The tape elements 317 of the inner winding 316 may include different tape widths to provide different bending stiffnesses in different regions 330, 340, and 350. In some examples, at least one tape element 332 in region 330 has a tape width W3. At least one tape element 342 in region 340 has a tape width W4. At least one tape element 352 in region 350 has a tape width W5. Tape width W5 is wider than tape width W4, and tape width W4 is wider than tape width W3. In regions with wider tape widths, such as region 350, the elongated device 150 has a higher bending stiffness than in regions with narrower tape widths. As the tape width of the tape element 317 narrows, the bending stiffness of the winding layer 310 decreases, and the corresponding region of the elongated device 150 may become more flexible. Therefore, the bending stiffness of the elongated device 150 is highest in region 350, while the bending stiffness of the elongated device 150 is lowest in region 330. The bending stiffness of the elongated device 150 in region 340 is higher than that in region 330, but lower than that in region 350. Figure 2BIn the example shown, the bending stiffness of the elongated device 150 gradually decreases from a maximum bending stiffness at the proximal portion 318 of the wound layer 310 in the region 350 to a minimum bending stiffness at the distal portion 320 of the wound layer 310 in the region 330. In this manner, the proximal portion 318 is stiffer than the distal portion 320. In some examples, the bending stiffness of the elongated device 150 gradually decreases in a uniform pattern from a maximum bending stiffness at the proximal portion 318 of the wound layer 310 in the region 350 to a minimum bending stiffness at the distal portion 320 of the wound layer 310 in the region 330. In other examples, the bending stiffness of the elongated device 150 gradually decreases in a non-uniform pattern from a maximum bending stiffness at the proximal portion 318 of the wound layer 310 in the region 350 to a minimum bending stiffness at the distal portion 320 of the wound layer 310 in the region 330.

[0052] In some examples, the band width of the band element 317 varies from the narrowest band width W6 to the widest band width W7. For example, the band width of the band element 317 may gradually increase from the narrowest band width W6 to the widest band width W7 in a uniform pattern. Alternatively, the band width of the band element 317 may gradually increase from the narrowest band width W6 to the widest band width W7 in a non-uniform pattern. The more distal band element 317D may have a band width W6, while the more proximal band element 317P may have a widest band width W7. In some examples, when moving from the more distal band element 317D to the more proximal band element 317P, each continuous band element may have a wider band width than its previous band element. Therefore, the band width of the band element 317 may gradually widen from the narrowest band width W6 to the widest band width W7. This may result in a gradient of increased bending stiffness from the distal portion 320 to the proximal portion 318. In another example, the direction of the bending stiffness gradient may be reversed using a tape width that continuously narrows from the distal portion 320 to the proximal portion 318. In another example, the tape width within each of the regions 330, 340, and 350 may be the same, while the tape widths of different regions 330, 340, and 350 are different to achieve different bending stiffnesses within the regions 330, 340, and 350.

[0053] Figure 2BThe band width of the illustrated band element 317 can be customized, adjusted, or varied in any manner such that the band width of the band element 317 is sized in any desired pattern or arrangement to achieve a desired bending stiffness distribution along the length of the elongated device 150. For example, the band width of the band element 317 can be sized such that the bending stiffness of the elongated device 150 increases from a minimum bending stiffness at the proximal portion 318 of the wound layer 310 in region 350 to a maximum bending stiffness at the distal portion 320 of the wound layer 310 in region 330. In this example, the distal portion 320 is stiffer than the proximal portion 318. In another example, the band width of the band element 317 can be sized such that the bending stiffness of the elongated device 150 is maximum bending stiffness at the proximal portion 318 and the distal portion 320 and minimum bending stiffness at a center point along the axial length of the wound layer 310. In this example, the proximal portion 318 and the distal portion 320 are stiffer than the middle of the elongated device 150. In another example, the tape width of the tape element 317 can be sized so that the bending stiffness of the elongated device 150 remains constant along the axial length of the wound layer 310. The tape width of the tape element 317 can be sized in any other customized configuration to provide greater or lesser stiffness at selected sections along the length of the wound layer 310.

[0054] In some examples, the elongated device 150 may include an articulatable distal section 360 (eg, Fig.13 The distal end 218 in Figure 3 The proximal end 362 of the articulatable distal portion 360 can be coupled to the distal portion 320 of the coiled layer 310. In some examples, the coiled layer 310 is located at a non-articulatable proximal section 319 (e.g., Fig.13 The catheter 180 ( Figure 3 ) around the pull wire 185 (not shown) for controlling the articulation of the articulatable distal section 360. Figure 3 310) and may extend within the non-articulate proximal section 319 and terminate at or within the articulate distal section 360. For example, the catheter may extend through the non-articulate proximal section 319 within the lumen formed by the coiled layer 310, such as Figure 1AAs shown. In some examples, the catheter 180 may be between adjacent windings of the winding layer 310. The pull wire 185 may extend through the catheter 180 and extend to the outside of the catheter 180 to couple to various positions of the articulated distal segment 360. The pull wire 185 can be actuated to bend the articulated distal segment 360. Bending the articulated distal segment 360 can guide the distal end 364 of the articulated distal segment 360 in any desired direction, such as along the pitch axis and the yaw axis. The elongated device 150 can be manipulated by bending the articulated distal segment 360 and inserting the elongated device 150 into an anatomical structure (e.g., a respiratory passage). The articulated and manipulable elongated device is described in more detail in U.S. Patent Application No. 16 / 877,760, entitled "Flexible Instrument with Grooved Steerable Tube" filed on May 19, 2020 (which is incorporated herein by reference in its entirety). Figure 3 The outer coils 312 and the middle coils 314 are shown terminating proximally of the distal portion 320 of the coil layer 310. In some examples, the outer coils 312 and / or the middle coils 314 continue to the articulatable distal section 360 along at least a portion of the axial length.

[0055] The outer winding 312, the middle winding 314 and the inner winding 316 of the winding layer 310 may have different configurations, such as different pitch directions and / or different sizes or shapes. The pitch direction refers to the alignment direction of the winding tape element, such as in the example where the tape element is formed by a wire material, the pitch direction may be defined by the winding direction of the winding, or in the example where the winding is formed by a sea wave tube, the pitch direction may be defined by the direction of the slit between the tape elements. Adjacent windings of the winding layer 310 may have opposite pitch directions to accommodate sharp turns (e.g., small radius of curvature). For example, when the outer winding 312 and the middle winding 314 have opposite pitch directions, the outer winding 312 and the middle winding 314 may be able to bend to a sharper radius of curvature than a single winding can be bent or than two windings with the same pitch direction can be bent, without causing permanent deformation of the material of the outer winding 312 and the middle winding 314. Having the outer and middle coils 312, 314 include opposite pitch directions may also help prevent one or more tape elements 315 of the middle coil 314 from becoming stuck in gaps 311 between two or more tape elements 313 of the outer coils 312 when the elongated device 150 is bent.

[0056] For example, Figure 4A side view of a portion 325 of the wound layer 310 is shown. The portion 325 can be located at any axial position along the length of the wound layer 310 (e.g., at the distal portion 320, near the distal portion 320, at the proximal portion 318, near the proximal portion 318, or anywhere between the distal portion 320 and the proximal portion 318). The ribbon elements 313 of the outer winding 312 are oriented along the pitch direction D1, the ribbon elements 315 of the middle winding 314 are oriented along the pitch direction D2, and the ribbon elements 317 of the inner winding 316 are oriented along the pitch direction D1. In examples when the outer winding 312 is a filament, the pitch direction D1 can indicate the winding direction of the ribbon elements 313 of the outer winding 312. In examples when the outer winding 312 is a hypotube, the pitch direction D1 can indicate the helical direction of the helical ribbon elements 313 of the outer winding 312. In examples when the middle winding 314 is made of wire, the pitch direction D2 may indicate the winding direction of the ribbon element 315 during the winding or coiling process. In examples when the middle winding 314 is cut from a hypotube, the pitch direction D2 may indicate the spiral direction of the cut pattern of the middle winding 314. In examples when the inner winding 316 is made of wire or coiled from wire, the pitch direction D1 may indicate the winding direction of the ribbon element 317 of the inner winding 316. In examples when the inner winding 316 is a hypotube, the pitch direction D1 may indicate the spiral direction of the cut pattern that creates the spiral ribbon element 317 of the inner winding 316.

[0057] At least one winding of the winding layer 310 may be oriented along a pitch direction that is different from the pitch directions of the other windings of the winding layer 310. Figure 4 As shown, the outer winding 312 and the inner winding 316 are both oriented along the pitch direction D1, while the middle winding 314 is oriented along the pitch direction D2. In other examples, the outer winding 312 may be oriented along a pitch direction (e.g., pitch direction D1) different from the middle winding 314 and the inner winding 316, and the middle winding 314 and the inner winding 316 may be oriented along the pitch direction D2. In other examples, the inner winding 316 may be oriented along a pitch direction (e.g., pitch direction D1) different from the outer winding 312 and the middle winding 314, and the outer winding 312 and the middle winding 314 may be oriented along the pitch direction D2. The outer winding 312, the middle winding 314, and the inner winding 316 may be oriented along any other combination of pitch directions, when one of the outer winding 312, the middle winding 314, or the inner winding 316 is oriented in a pitch direction different from the pitch direction of the other windings. The outer winding 312 may be oriented in the pitch direction D1 or the pitch direction D2. The middle winding 314 may be oriented in the pitch direction D1 or the pitch direction D2. The inner winding 316 may be oriented in the pitch direction D1 or the pitch direction D2.

[0058] Figure 4Pitch cone angles 410, 420, 430 are shown relative to the longitudinal axis A of the winding layer 310. Pitch cone angle 410 is the pitch cone angle of the tape element 313 of the outer winding 312. Pitch cone angle 420 is the pitch cone angle of the tape element 315 of the middle winding 314. Pitch cone angle 430 is the pitch cone angle of the tape element 317 of the inner winding 316. The pitch cone angles between the windings of the winding layer 310 (e.g., the outer winding 312, the middle winding 314, and the inner winding 316) can affect the ability of the winding layer 310 to resist elongation of the winding layer 310 (e.g., excessive stretching of the winding layer 310 causes the winding layer 310 to deform axially). For example, when the pitch cone angle of each winding of the winding layer 310 is within a tight range (e.g., a 10° range, a 15° range, or a 20° range), the winding layer 310 may have a higher resistance to elongation than when the pitch cone angle is within a wide range (e.g., a 45° range, a 60° range, or a 90° range). When the pitch cone angle of the tape elements of each winding of the winding layer 310 is close to 0° or 180°, the resistance to elongation approaches the maximum resistance to elongation. When the pitch cone angle of the tape elements of each winding of the winding layer 310 is close to 90°, the resistance to elongation approaches the minimum resistance to elongation. In some examples, if the pitch cone angle 410 is 120°, the pitch cone angle 420 is 80°, and the pitch cone angle 430 is 120°, the winding layer 310 may have a higher resistance to elongation than when the pitch cone angle is close to 90°. In some examples, if the pitch cone angle 410 is 95°, the pitch cone angle 420 is 85°, and the pitch cone angle 430 is 150°, the winding layer 310 may have a higher resistance to elongation than when all three pitch cone angles are close to 90°. Additionally, in some examples, the pitch cone angle 430 of the tape element 317 of the inner winding 316 may be close to 90° (e.g., 85°, 87°, 92°, or 95°), and the pitch cone angle 420 of the tape element 315 of the middle winding 314 and / or the pitch cone angle 410 of the tape element 313 of the outer winding 312 may be farther from 90° (e.g., 60°, 70°, 110°, or 120°). In such examples, the winding layer 310 may provide a smooth passage for a tool extending through the cavity of the inner winding 316 while maintaining resistance to elongation. Figure 4 In the example shown, the winding layer 310 may have a higher resistance to elongation than a winding layer of a winding having a pitch cone angle within a wide range. For example, the pitch cone angle 410 may be 95°, the pitch cone angle 420 may be 85°, and the pitch cone angle 430 may be 100°. The pitch cone angle 410, the pitch cone angle 420, and the pitch cone angle 430 are within a range of 15° from each other, which may be a tight range. One or more of the pitch cone angle 410, the pitch cone angle 420, and the pitch cone angle 430 may be adjusted to adjust the resistance to elongation of the winding layer 310.

[0059] In some examples, if the pitch cone angle 410 is 60°, the pitch cone angle 420 is 80°, and the pitch cone angle 430 is 60°, the winding layer 310 may have a higher resistance to elongation than when the pitch cone angle is close to 90°. In some examples, if the pitch cone angle 410 is 85°, the pitch cone angle 420 is 85°, and the pitch cone angle 430 is 75°, the winding layer 310 may have a higher resistance to elongation than when all three pitch cone angles are close to 90°. Additionally, in some examples, the pitch angle 430 of the tape element 317 of the inner coil 316 may be close to 90° (e.g., 85°, 86°, 87°, 88°, or 89°), while the pitch angle 420 of the tape element 315 of the middle coil 314 and / or the pitch angle 410 of the tape element 313 of the outer coil 312 may be further away from 90° (e.g., 50°, 60°, or 70°). In such examples, the coil layer 310 may provide a smooth passage for a tool extending through the cavity of the inner coil 316 while maintaining resistance to elongation. Figure 4 In the example shown, the winding layer 310 may have a higher resistance to elongation than a winding layer of a winding having a pitch cone angle within a wide range. For example, the pitch cone angle 410 may be 85°, the pitch cone angle 420 may be 85°, and the pitch cone angle 430 may be 80°. The pitch cone angle 410, the pitch cone angle 420, and the pitch cone angle 430 are within a range of 15° from each other, which may be a tight range. One or more of the pitch cone angle 410, the pitch cone angle 420, and the pitch cone angle 430 may be adjusted to adjust the resistance to elongation of the winding layer 310.

[0060] In some examples, the pitch cone angle 410, the pitch cone angle 420, and the pitch cone angle 430 are different angles. In some examples, two or more of the pitch cone angle 410, the pitch cone angle 420, and the pitch cone angle 430 may be the same. In some examples, windings oriented along the same pitch direction may have the same pitch cone angle. For example, if the outer winding 312 and the inner winding 316 are oriented along the pitch direction D1, the pitch cone angle 410 of the outer winding 312 and the pitch cone angle 430 of the inner winding 316 may be the same angle.

[0061] When adjacent windings are oriented in opposite pitch directions (or when at least two windings are oriented in opposite pitch directions), the elongated device 150 may be more able to accommodate sharp turns (e.g., small radii of curvature). For example, a single winding or multiple windings oriented in the same pitch direction may cause the elongated device 150 to be susceptible to permanent kinking and / or deformation during bending of the elongated device 150. In examples when two windings of the winding layer 310 are oriented in opposite pitch directions, the winding layer 310 may provide increased stiffness to the elongated flexible device 150 so that the elongated flexible device 150 can be bent to a small radius of curvature without permanent kinking or deformation. Additionally, when adjacent windings are oriented in opposite pitch directions (or when at least two windings are oriented in opposite pitch directions), the elongated device 150 may have greater torsional resistance than when the adjacent windings are oriented in the same pitch direction. In some examples, when the winding layer 310 includes three windings (e.g., outer winding 312, middle winding 314, and inner winding 316) oriented in alternating pitch directions, the elongated device 150 has bidirectional torsional resistance. For example, when torque is applied in one direction, the inner winding 316 may expand, the middle winding 314 may contract, and the outer winding 312 may expand. When torque is applied in the opposite direction, the inner winding 316 may contract, the middle winding 314 may expand, and the outer winding 312 may contract. When torque is applied in both directions, the expansion and contraction generated between the windings causes the elongated device 150 to have bidirectional torsional resistance. When adjacent windings of the winding layer 310 have opposite pitch directions, when the winding layer 310 is bent, the possibility of the tape elements of the windings being stuck in the gaps formed between the tape elements of the adjacent windings is reduced. For example, when the elongated device 150 is bent, the tape element 315 of the middle coil 314 is less likely to get stuck between two or more of the tape elements 313 of the outer coil 312 or in a gap between two or more of the tape elements 317 of the inner coil 316 .

[0062] In some examples, one, some, or all of the outer windings 312, the middle windings 314, and the inner windings 316 may be closed pitch. When the windings are closed pitch, when the winding layer 310 is straightened, there are no gaps between the tape elements of the windings. In some examples, one, some, or all of the outer windings 312, the middle windings 314, and the inner windings 316 may be open pitch. When the windings are open pitch, there are gaps between the tape elements of the windings.

[0063] Figure 5A and Figure 5B A side view of an outer coil 312 having an open pitch is shown. An open pitch means that when the coil is straightened, the coil has gaps between adjacent tape elements. One or more coils of the coil layer 310 may have an open pitch. Although Figure 5A and Figure 5BThe outer winding 312 is discussed, but the discussion applies to each of the middle winding 314 and the inner winding 316. In examples when one or more windings of the winding layer 310 have an open pitch, the (one or more) windings include gaps between one or more tape elements of the (one or more) windings. For example, the outer winding 312 may include gaps 311 between one or more tape elements 313 of the outer winding 312. In some examples, each of the gaps 311 between the tape elements 313 has the same width. Alternatively, one or more of the gaps 311 can be different widths. The width of the gaps 311 between the tape elements 313 can vary along the length of the outer winding 312 in any arrangement or pattern.

[0064] In some examples, the winding may include multiple strips that are interwoven. Figure 5B As shown, the outer coil 312 includes two ribbons 370A, 370B that are interwoven. In some examples, the middle coil 314 and / or the inner coil 316 additionally or alternatively include multiple ribbons.

[0065] In some examples, one or more of the windings of the winding layer 310 can be made of wire or coiled from wire. The winding can be made of or formed from multi-filar wire or single filar wire. Figure 5A In some examples, outer winding 312 is a monofilament filament. Middle winding 314 and / or inner winding 316 may also be a monofilament filament. In some examples, one or more of outer winding 312, middle winding 314, and inner winding 316 may be a multifilament filament (e.g., see Figure 5B 310 , wherein each of the tapes 370A and 370B is made of one wire). In some examples, the tape(s) of one or more of the outer winding 312, the middle winding 314, or the inner winding 316 may be formed of round wire. In some examples, the tape(s) of one or more of the outer winding 312, the middle winding 314, or the inner winding 316 may be formed of flat wire. Any combination of monofilament wire, multifilament wire, round wire, flat wire, open pitch winding, closed pitch winding, variable tape width, and uniform tape width may be used in the winding layer 310.

[0066] In some examples, the (one or more) bands of one or more of the outer winding 312, the middle winding 314, or the inner winding 316 may be made of a tube (such as a hypotube). The tube may be laser cut to create a slit that defines the band element, pitch direction, and pitch cone angle of the winding. In some examples, the tube may be water jet cut to create a band element from the tube. In other examples, the tube may be plasma cut or mechanically cut to create a band element from the tube. In some examples, one or more of the outer winding 312, the middle winding 314, or the inner winding 316 may be 3D printed. For example, a winding with a variable band width (such as the inner winding 316) may be 3D printed. In some examples, the winding with a variable band width is made of a filament. The filament may have a variable cross-sectional dimension along its length to provide a variable band width, and the winding may be created by winding the filament to create a band element of different band widths.

[0067] Each winding of the winding layer 310 can be made of a metal material, a polymer material, a composite material, or any other suitable material. For example, one or more of the outer winding 312, the middle winding 314, and the inner winding 316 can be made of stainless steel. In another example, one or more of the outer winding 312, the middle winding 314, and the inner winding 316 can be made of a carbon fiber epoxy composite material. All windings of the winding layer 310 can be made of the same material, or different windings can be made of different materials.

[0068] In some examples, adjacent windings of the winding layer 310 may be joined or otherwise secured together at different locations along the length of the winding layer 310. For example, the outer winding 312, the middle winding 314, and the inner winding 316 may be joined together at the proximal portion 318 and the distal portion 320 of the winding layer 310. In other examples, adjacent windings are not joined to each other.

[0069] The bonding technique used to bond adjacent windings may be any type of appropriate bonding technique suitable for the particular material used for the windings. For example, adjacent metal windings may be welded together at one or more welding locations. The type(s) of weld(s) used to weld adjacent windings together may be any one or more of spot welds, electroresistive welds, seam welds, laser welds, any combination thereof, and / or any other type of weld. Additionally or alternatively, adjacent windings may be bonded together with an adhesive or other bonding material.

[0070] Figure 6 is a flow chart illustrating a method 600 of manufacturing a wound layer (eg, wound layer 310) of a flexible elongated device (eg, flexible elongated device 150). Figure 2A and Figure 2B 6. The method 600 is illustrated as a set of operations or processes 602-606. Figure 6 The process shown in Figure 6 In some examples of method 600, one or more of the processes shown may not be performed. Figure 6 One or more processes not explicitly shown in the diagram may be included before, after, between, or as a part of the shown process.

[0071] At process 602, at least two windings are constructed. For example, at least two of the outer winding 112, the middle winding 114, and the inner winding 116 are constructed. For example, one or more of the windings can be a tube (such as a hypotube) that can be laser cut to create a slit or gap that defines the tape element, pitch direction, and pitch cone angle of the winding. In some examples, the tube can be water jet cut to create a tape element from the tube. In other examples, the tube can be plasma cut or mechanically cut to create a tape element from the tube. In some examples, one or more of the windings can be 3D printed. In some examples, one or more of the windings can be formed by wire or wound by wire. (One or more) windings can be created by winding wire to create tape elements of different tape widths or different pitches.

[0072] At process 604, winding layer 310 may be constructed using at least two of outer winding 112, middle winding 114, and inner winding 116. For example, inner winding 116 may be located within a cavity of middle winding 114, and / or middle winding 114 may be located within a cavity of outer winding 112.

[0073] At process 606, the individual windings of the winding layer 310 may be bonded together. For example, the individual windings of the winding layer 310 may be welded together and / or bonded together with an adhesive or other bonding material. The individual windings may be bonded together at one or more locations along the length of each winding.

[0074] In the example where each winding is welded together, the position and quantity of the weld will change the bending stiffness of the winding, and therefore change the bending stiffness of the medical device. For example, the weld on the continuous band will increase the bending stiffness, and the influence of the weld on the bending stiffness of every five bands will be less. Alternatively, several welds around the circumference of the winding, between the inner winding and the outer winding, increase the bending stiffness more than a single weld in a position only on the circumference. The variable stiffness axis can be constructed by welding each band in the proximal section of the medical device, welding every fifth band in the middle section, and welding every tenth band in the distal section. Alternative bending stiffness distribution can be achieved by alternative welding distribution, as discussed in more detail below. For example, the outer winding 312 and the middle winding 314 can be welded together. Additionally or alternatively, the middle winding 314 and the inner winding 316 can be welded together. Additionally or alternatively, the outer winding 312, the middle winding 314, and the inner winding 316 may all be welded together.

[0075] Fig. 7A A side view of a coil layer 710 (e.g., coil layer 310 and / or coil layer 170) of an exemplary flexible elongated device (e.g., flexible elongated device 150) is shown. The elongated device 150 can be a catheter, an instrument (e.g., a medical device), a sheath, or any other flexible elongated body. The coil layer 710 can assist in maintaining the patency of a lumen (e.g., lumen 155) of the elongated device 150 during articulation of the elongated device 150. The coil layer 710 can also provide flexibility to the elongated device 150 while achieving variable bending stiffness of the elongated device 150. The coil layer 710 can also provide structural support to the elongated device 150. The elongated device 150 can also have a plurality of coil layers that are not in the elongated device 150 in addition to the coil layer 710. Figure 2A The components shown in Figure 1A and Figure 1B Components discussed. In some examples, elongated device 150 has a variable bending stiffness along its length.

[0076] The winding layer 710 may include at least two layers of windings, such as an outer winding 712 (eg, the outer winding 312 ) and an inner winding 714 (eg, the middle winding 314 or the inner winding 316 ). Figure 7B A side view of an outer coil 712 and an inner coil 714 is shown. In some examples, the outer coil 712 defines a cavity, and the inner coil 714 can extend within the cavity. In some examples, the coil layer 710 includes more than two coils (e.g., three coils, four coils, etc.). The coil layer 710 further includes a proximal portion 716 (e.g., the proximal portion 318) and a distal portion 718 (e.g., the distal portion 320). The proximal portion 716 can be adjacent to the drive unit 204 (see FIG. 20A ) of the medical device system 200. Fig.13The distal portion 718 is distal to the proximal portion 716 and can be located at or adjacent to the distal end 218 of the elongated device 202 of the medical device system (see Fig.13 ). The outer winding 712 includes a tape element 717. The inner winding 714 includes a tape element 719. In some examples, each of the tape elements 717 of the outer winding 712 has a tape width W1. Alternatively, one or more of the tape elements 717 may have different tape widths, as discussed above with respect to the winding layer 310. The tape widths of the tape elements 717 may vary along the length of the outer winding 712 in any arrangement or pattern, as discussed above with respect to the winding layer 310. In some examples, one of the tape elements 719 of the inner winding 714 has a tape width W2. Alternatively, one or more of the tape elements 719 may have different tape widths, as discussed above with respect to the winding layer 310. The tape widths of the tape elements 719 may vary along the length of the inner winding 714 in any arrangement or pattern, as discussed above with respect to the winding layer 310. In some examples, the tape width W2 of one or more of the tape elements 719 is the same as the tape width W1 of one or more of the tape elements 717 .

[0077] In some examples, the outer winding 712 may include gaps 713 between one or more tape elements 717 of the outer winding 712. The inner winding 714 may include gaps 713 between one or more tape elements 719 of the inner winding 714. In some examples, each of the gaps 713 between the tape elements 717 of the outer winding 712 has the same width. Alternatively, one or more of the gaps 713 between the tape elements 717 may have different widths. The width of the gaps 713 between the tape elements 717 may vary along the length of the outer winding 712 in any arrangement or pattern. In some examples, each of the gaps 713 between the tape elements 719 of the inner winding 714 has the same width. Alternatively, one or more of the gaps 713 between the tape elements 719 may have different widths. The width of the gaps 713 between the tape elements 719 may vary along the length of the inner winding 714 in any arrangement or pattern. In some examples, the width of one or more of the gaps 713 between the strap elements 719 is the same as the width of one or more of the gaps 713 between the strap elements 717 .

[0078] Fig. 7A and Figure 7B The ribbon element 717 of the outer winding 712 and the ribbon element 719 of the inner winding 714 are shown terminating proximal to the distal portion 718 of the winding layer 710. In some examples, the ribbon element 717 of the outer winding 712 and the ribbon element 719 of the inner winding 714 continue all the way to the distal portion 718. Fig. 7A and Figure 7BAlso shown are the tape elements 717 of the outer winding 712 and the tape elements 719 of the inner winding 714 terminating at the distal end of the proximal portion 716 of the winding layer 710. In some examples, the tape elements 717 of the outer winding 712 and the tape elements 719 of the inner winding 714 continue all the way to the proximal portion 716. One or both of the outer winding 712 and the inner winding 714 may have a cross-section that is circular, hexagonal, octagonal, or some other shaped cross-section.

[0079] The outer coil 712 and the inner coil 714 can be joined together by one or more joints 725 located at one or more joint positions 720 along the axial length of the coil layer 710, which extends along the axis A. The joints 725 can be spaced apart from each other at variable distances to allow the elongated device 150 to have a variable bending stiffness that can be adjusted to a customized bending stiffness distribution. A higher spatial density of joints 725 at a certain area of ​​the coil layer 710 corresponds to a higher bending stiffness at that area of ​​the coil layer 710. Similarly, a lower spatial density of joints 725 corresponds to a lower bending stiffness. Therefore, the joints 725 can be positioned at different joint positions 720 to achieve different bending stiffness distributions along the axial length of the elongated device 150.

[0080] In some examples, the wound layer 710 may include different regions 730, 740, 750, 760 with different bending stiffnesses along its axial length. Region 730 is the most distal region. Region 740 is proximal to region 730 and distal to region 750. Region 750 is proximal to region 740 and distal to region 760. Region 760 is the most proximal region. Fig. 7A The arrangement and number of regions shown is an example. Any other arrangement (e.g., order, length) or number of regions may be used.

[0081] Regions 730, 740, 750, 760 include respective subsets 735, 745, 755, 765 of bonds located at bonding locations 720. Bonds 725 in subset 735 of bonds in region 730 are axially spaced apart from each other by a length L1. Bonds 725 in subset 745 of bonds in region 740 are axially spaced apart from each other by a length L2. Bonds 725 in subset 755 of bonds in region 750 are axially spaced apart from each other by a length L3. Bonds 725 in subset 765 of bonds in region 760 are axially spaced apart from each other by a length L4. As the length between bonds 725 decreases, the spatial density of bonds 725 increases. Length L1 is longer than length L2, length L2 is longer than length L3, and length L3 is longer than length L4. Therefore, the spatial density of the joint 725 in region 760 is higher than the spatial density of the joint 725 in region 750, the spatial density of the joint 725 in region 750 is higher than the spatial density of the joint 725 in region 740, and the spatial density of the joint 725 in region 740 is higher than the spatial density of the joint 725 in region 730.

[0082] In regions where the spatial density of the joints 725 is high, such as region 760, the elongated device 150 has a high bending stiffness. As the spatial density of the joints 725 decreases, the bending stiffness of the elongated device 150 decreases, and the elongated device 150 becomes more flexible. Thus, the bending stiffness of the elongated device 150 is highest in region 760, while the bending stiffness of the elongated device 150 is lowest in region 730. The bending stiffness of the elongated device 150 in region 740 is higher than the bending stiffness in region 730, but lower than the bending stiffness in region 750. The bending stiffness of the elongated device 150 in region 750 is higher than the bending stiffness in region 740, but lower than the bending stiffness in region 760. In Fig. 7A In the example shown, the bending stiffness of the elongated device 150 variably decreases from a maximum bending stiffness at the proximal portion 716 of the wound layer 710 in region 760 to a minimum bending stiffness at the distal portion 718 of the wound layer 710 in region 730. In this manner, the proximal portion 716 is stiffer than the distal portion 718. Each region 730, 740, 750, and 760 is shown as having a consistent spacing between the bonds 725, but the spacing between adjacent bonds 725 within a region is not necessarily the same.

[0083] By customizing the locations where the outer coils 712 and the inner coils 714 join, the bending stiffness of the elongated device 150 can be adjusted to a customized bending stiffness profile. The bending stiffness can vary along the axial length of the coil layer 710, for example, when the junctions 725 are selected to be located at locations with varying spacing along the axial length. In some examples, a ratio of ? Fig. 7A More or fewer binding locations 720 are shown. The Fig. 7A The bonding locations 720 shown may be positioned at any desired locations in any desired pattern or arrangement. For example, the bonding locations 720 may be defined such that the bending stiffness of the elongated device 150 is variably increased from a minimum bending stiffness at the proximal portion 716 of the wound layer 710 in region 760 to a maximum bending stiffness at the distal portion 718 of the wound layer 710 in region 730. In this example, the distal portion 718 is stiffer than the proximal portion 716.

[0084] In another example, the bonding locations 720 may be defined such that the bending stiffness of the elongated device 150 is at a maximum bending stiffness at the proximal portion 716 and the distal portion 718, and at a minimum bending stiffness at a central point along the axial length of the wound layer 710. In this example, the proximal portion 716 and the distal portion 718 are stiffer than the middle of the elongated device 150. In another example, the bonding locations 720 may be defined such that the bending stiffness of the elongated device 150 remains constant along the axial length of the wound layer 710. The bonding locations 720 may be positioned at any other location in any other customized configuration to provide greater or lesser stiffness at selected sections along the length of the wound layer 710.

[0085] In some examples, the winding layer 710 includes more than two windings (e.g., three windings, four windings, etc.). In examples where the winding layer 710 includes three windings, the junction 720 may be between the first winding and the second winding, or the junction 720 may be between the second winding and the third winding. In some examples, some junctions 720 may be between the first winding and the second winding, while other junctions 720 may be between the second winding and the third winding. The junctions 720 may have a variable spatial density to achieve variable bending stiffness as discussed above.

[0086] One or more of the joints 725 has an axial length AL, such as Figure 7CAs shown. In some examples, each of the joints 725 may have the same axial length AL. In other examples, some or all of the joints 725 have different axial lengths AL. For example, the axial length AL of one or more of the joints 725 may be equal to the band width W1 of one band element 717 of the outer winding 712. In some examples, the axial length of one or more of the joints 725 may span three band elements 717 of the outer winding 712. For example, the axial length AL of one or more of the joints 725 may be equal to the band width W3 of the three band elements 717 of the outer winding 712. The joint 725 may have any other axial length. A longer axial joint length results in a higher bending stiffness at this particular joint position. As discussed above, by changing the axial joint length of one or more of the joints 725 and changing the spatial density of the joints 725, the bending stiffness distribution of the elongated device 150 can be further adjusted and customized.

[0087] In some examples, the outer coil 712 may include gaps 713 between one or more tape elements 717 of the outer coil 712. The axial length AL of one or more of the joints 725 may span from one gap 713 to another gap 713, such as when the axial length AL is equal to the tape width W1 of the outer coil 712. In some examples, the axial length AL of one or more of the joints 725 may be shorter than the tape width W1.

[0088] The spatial density of the bonds 725 along different dimensions can be varied to achieve variable bending stiffness of the wound layer 710. Fig. 7A Bonding locations 720 are shown only on one side (e.g., on the top side) of the winding layer 710, but multiple bonding locations 720 may be located along the radial length of the elongated device 150 (e.g., along the arc 715 of the winding layer 710 defined between the outer winding 712 and the inner winding 714). Fig.7D As shown, the joints 725 may be located at joint locations 720 spaced around the arc 715. In some examples, the Fig.7D More or fewer bonding locations 720 are shown. Bonding locations 720 may be selected, customized, adjusted, or altered in any manner such that bonding locations 720 are positioned at any desired locations in any desired pattern or arrangement.

[0089] The spatial density of the bonds 725 defined by the spaces between adjacent bond locations 720 may vary along the arc 715. In general, the higher the spatial density of the bonds 725 along the arc 715, the higher the bending stiffness of the wound layer 710 at or near the arc 715. For example, the bonds 725 may be positioned at one or more of the bond locations 720 along the arc 715 (e.g., at the 0° position, the 90° position, the 180° position, or the 270° position defined by the axis 775), or at any other radial position. This may allow the bending stiffness of the elongated device 150 to vary in one or more bending planes. For example, if all of the bond locations 720 are located above the bending plane AA (e.g., between the 0° position and the 180° position), the bending stiffness of the elongated device 150 above the bending plane AA will be greater than the bending stiffness below the bending plane AA.

[0090] In some examples, the bonding locations 720 may be radially paired at 180° radial intervals, as described below with respect to Fig.10 This is discussed in further detail. For example, if one binding position 720 is at the 90° position, another paired binding position 720 may be at the 270° position. Similarly, if one binding position 720 is at the 0° position, another paired binding position 720 may be at the 180° position. The binding positions 720 may be paired at any other radial intervals (e.g., a pair of 30° and 210°, a pair of 45° and 225°, etc.). The binding positions 720 may be grouped at any other radial intervals, which may be greater than or less than the 180° radial intervals. For example, a binding position at the 45° position may be grouped with another binding position at the 135° position. In some examples, three or more binding positions 720 may be grouped together (e.g., binding positions at the 0° position, the 90° position, and the 180° position).

[0091] In some examples, the elongated device 150 may include an articulatable distal section 770 (eg, articulatable distal section 370), such as Figure 8 As shown, it can be Fig.13770. The proximal end 772 of the articulable distal segment 770 may be coupled to the distal segment 718 of the coiled layer 710. In some embodiments, the coiled layer 710 is located in a non-articulable proximal segment of the elongated device 150 proximal to the proximal end 772 of the articulable distal segment 770. A catheter (not shown) may extend through the non-articulable coiled layer 710. The catheter may also extend into part or all of the articulable distal segment 770. A pull wire (not shown) may extend through the catheter and may be coupled to various locations of the articulable distal segment 770. The pull wire may be actuated to bend the articulable distal segment 770. Bending the articulable distal segment 770 may direct the distal end 774 of the articulable distal segment 770 in any desired direction, such as along the pitch axis and the yaw axis. The elongated device 150 can be manipulated by bending the articulatable distal section 770 and inserting the elongated device 150 into an anatomical structure (e.g., a respiratory passage). An articulatable and manipulable elongated device is described in more detail in U.S. Patent Application No. 16 / 877,760, filed on May 19, 2020, entitled “Flexible Instrument with Grooved Steerable Tube” (which is incorporated herein by reference in its entirety). Figure 8 Shown are the strap elements 717 of the outer coil 712 and the strap elements 719 of the inner coil 714 terminating proximally of the distal portion 718 of the coil layer 710 . In some examples, the strap elements of the outer coil 712 and the inner coil 714 continue all the way to the articulatable distal section 770 .

[0092] The outer windings 712 and the inner windings 714 of the winding layer 710 can be wound in a variety of configurations and / or can be sized and shaped in a variety of different configurations. For example, Fig.9AA side view of a distal portion of the winding layer 710 is shown. The tape elements 717 of the outer winding 712 and the tape elements 719 of the inner winding 714 have the same pitch direction P1, which is measured about the longitudinal axis A of the winding layer 710. In some examples when the outer winding 712 and the inner winding 714 have the same pitch direction, any gaps are not visible when the winding layer 710 is bent. For example, when the winding layer 710 is bent, the tape elements 717 of the outer winding 712 can cover any gaps that may open between the tape elements 719 of the inner winding 714. Additionally, when the outer winding 712 and the inner winding 714 have the same pitch direction (e.g., pitch direction P1), when a torque is applied to the winding layer 710 in a clockwise direction, the winding layer 710 can have a higher torsional stiffness than when the torque is applied to the winding layer 710 in a counterclockwise direction. In some examples, when the outer winding 712 and the inner winding 714 have the same pitch direction (e.g., pitch direction P2), when torque is applied to the winding layer 710 in a counterclockwise direction, the winding layer 710 may have a higher torsional stiffness than when torque is applied to the winding layer 710 in a clockwise direction.

[0093] In some examples, the outer windings 712 and the inner windings 714 may have the same pitch direction, but different pitch cone angles (eg, defined by different angles relative to the longitudinal axis A). Fig. 9B A side view of a distal portion of a winding layer 710 in an alternative configuration is shown, wherein the outer winding 712 and the inner winding 714 have opposite pitch directions. For example, the outer winding 712 is wound along the pitch direction P1, while the inner winding 714 is wound along the opposite pitch direction P2. In other examples, the outer winding 712 may be wound along the pitch direction P2, while the inner winding 714 may be wound along the pitch direction P1.

[0094] When the outer windings 712 and the inner windings 714 have opposite pitch directions, the elongated device 150 can be more adaptable to sharp turns (e.g., small radii of curvature). For example, when the outer windings 712 and the inner windings 714 have opposite pitch directions, the outer windings 712 and the inner windings 714 can be able to bend to a sharper radius of curvature than a single winding can be bent or than two windings having the same pitch direction can be bent without causing permanent deformation of the material of the outer windings 712 and the middle windings 714. Having the outer windings 712 and the inner windings 714 include opposite pitch directions can also help prevent one or more strap elements 719 of the inner winding 714 from getting stuck in the gaps 713 between the two or more strap elements 717 of the outer windings 712 when the elongated device 150 is bent.

[0095] In some examples, the outer winding 712 and / or the inner winding 714 include a plurality of interlaced ribbons. Fig. 9CAs shown, the outer winding 712 includes two interlaced tapes 712A, 712B. Each of the tapes 712A, 712B surrounds the inner winding 714. In this example, the tapes 712A and 712B each have a pitch direction P1, while the inner winding 714 has an opposite pitch direction P2. In another example, the tapes of the inner winding 714 and the outer winding 712 may have the same pitch direction, i.e., P1 or P2. When the outer winding 712 includes two (or more) tapes 712A, 712B, the number of available bonding locations 720 between the outer winding 712 and the inner winding 714 can be increased. In some examples, the inner winding 714 includes multiple tapes.

[0096] like Figure 9A-9C As shown, each of the outer winding 712 and the inner winding 714 may have a consistent tape width along the length of the winding layer 710. For example, the tape width W1 of the outer winding 712 may remain consistent from the proximal portion 716 of the winding layer 710 to the distal section 718 of the winding layer 710. In some examples, the tape width of the inner winding 714 is the same as the tape width W1 of the outer winding 712. Alternatively, the tape width of the outer winding 712 and the tape width of the inner winding 714 may be different. In some examples, the tape width W1 of the outer winding 712 and / or the tape width of the inner winding 714 varies along the length of the winding layer 710, as discussed above with respect to the winding of the winding layer 310. For example, the tape width of the outer winding 712 may be wider at the proximal portion 716 than at the distal portion 718. Additionally or alternatively, the tape width of the inner coil 714 can be wider at the proximal portion 716 than at the distal portion 718. One or both of the outer coil 712 and the inner coil 714 can include any other configuration of variable tape width (e.g., wider at the distal portion 718 than at the proximal portion 716, wider in the middle of the coiled layer 710 than at the proximal portion 716 and the distal portion 718, or any other configuration). In some examples when the coils of the coiled layer 710 have variable tape widths, the coiled layer 710 can have variable bending stiffness due to the variable tape width.

[0097] In some examples, one or both of the outer winding 712 and the inner winding 714 may be closed pitch. When the winding is closed pitch, there are no gaps between the tape elements of the winding when the winding layer 710 is straightened. In examples where both the outer winding 712 and the inner winding 714 are closed pitch, the bonding location 720 may be on the tape element 717 of the outer winding 712 itself and the tape element 719 of the inner winding 714 itself. When the winding is open pitch, there are gaps between the tape elements of the winding.

[0098] In some examples, one or both of the outer winding 712 and the inner winding 714 may be a monofilament filament (see Fig.9A and Fig. 9BIn some examples, one or both of the outer winding 712 and the inner winding 714 may be a multifilament filament (see, e.g., Fig. 9C In some examples, the tape (or tapes) of one or both of the outer winding 712 and the inner winding 714 may be formed from round wire. In some examples, the tape (or tapes) of one or both of the outer winding 712 and the inner winding 714 may be formed from flat wire. Any combination of monofilament wire, multifilament wire, round wire, flat wire, open pitch winding, closed pitch winding, variable tape width, and uniform tape width may be used in the winding layer 710.

[0099] In some examples, the ribbon(s) of one or both of the outer winding 712 and the inner winding 714 may be formed from a hypotube. The hypotube may be laser cut to create a slit defining a spiral winding pattern in the hypotube. In some examples, the hypotube may be water jet cut to create a spiral winding pattern in the hypotube.

[0100] The outer winding 712 and the inner winding 714 can be metal materials, polymer materials or any other suitable materials. The bonding technology used to bond the outer winding 712 and the inner winding 714 at the bonding location 720 can be any type of appropriate bonding technology suitable for the specific materials of the outer winding 712 and the inner winding 714. For example, if the outer winding 712 and the inner winding 714 are metal, the outer winding 712 and the inner winding 714 can be welded together, wherein each joint is a welding location. The type of (one or more) welding used to weld the outer winding 712 and the inner winding 714 together can be any one or more of spot welding, resistance welding, seam welding, laser welding, any combination thereof and / or any other type of welding. Additionally or alternatively, the outer winding 712 and the inner winding 714 can be bonded together at the bonding location 720 with an adhesive or other bonding material.

[0101] Fig.10 A welding mechanism 800 is shown according to some examples. In some examples, the welding mechanism 800 can be used for resistance welding to form a joint in the winding layer 710. The welding mechanism 800 includes: a mandrel 810, which can be a conductive mandrel; one or more guide wheels 820; and one or more welding wheels 830, which can be seam welding wheels. The guide wheel 820 may include a groove 822 that is sized and shaped to receive the mandrel 810. In some examples, the guide wheel 820 may be made of a non-conductive material. The welding wheel 830 may include an outer surface 832 that contacts the mandrel 810 or any object that fits on the mandrel 810 (such as the winding layer 710). The welding wheel 830 is made of a conductive material. Although Fig.10 Two guide wheels 820 are shown in FIG. 8 , but the welding mechanism 800 may include any other number of guide wheels 820. Fig.10Two welding wheels 830 are shown in FIG. 8 , but the welding mechanism 800 may include any other number of welding wheels 830 .

[0102] The operation of the welding mechanism 800 will be described below with reference to Fig.11 Discuss in more detail. Fig.11 is a flow chart illustrating a method 900 of welding a wound layer (eg, wound layer 710 or wound layer 310) of a flexible elongated device (eg, flexible elongated device 150). Fig.10 Method 900 is discussed. Method 900 is illustrated as a set of operations or processes 902-906. Fig.11 The process shown in Fig.11 In some examples of method 900, one or more of the processes shown may not be performed. Fig.11 One or more processes not explicitly shown in the diagram may be included before, after, between, or as a part of the shown process.

[0103] At process 902, a wound layer (e.g., wound layer 710 or wound layer 310) of a flexible elongated device (e.g., flexible elongated device 150) is positioned around a conductive mandrel (e.g., conductive mandrel 810). Fig.10 As shown, the inner winding 714 may be positioned about the mandrel 810 and the outer winding 712 may be positioned about the inner winding 714 .

[0104] At process 904, the winding layer 710 is guided between a plurality of conductive wheels (e.g., welding wheels 830). When the winding layer 710 is guided between the welding wheels 830, the welding wheels 830 contact the winding layer 710. For example, the outer circumferential surface 832 of the welding wheel 830 may contact the winding layer 710. In some examples, the mandrel 810 and the winding layer 710 may be guided together along the D1 direction between the welding wheels 830. The winding layer 710 may be temporarily coupled to the mandrel 810, such as by an adhesive connection and / or a mechanical connection. After the outer winding 712 and the inner winding 714 are welded together, the winding layer 710 may be removed from the mandrel 810.

[0105] In some examples, the coiled layer 710 is also guided between the guide wheels 820. When the coiled layer 710 is guided between the guide wheels 820, the guide wheels 820 contact the coiled layer 710. When the coiled layer 710 and / or the mandrel 810 are guided between the guide wheels 820, the coiled layer 710 and / or the mandrel 810 may be received by the grooves 822 of the guide wheels 820. In some examples, the guide wheels 820 help position the coiled layer 710 and / or the mandrel 810 so that the coiled layer 710 is guided between the welding wheels 830.

[0106] In some examples, such as Fig.10As shown, the welding wheels 830 are equally spaced around the circumference of the wound layer 710. For example, the welding wheels 830 may be spaced 180° around the circumference of the wound layer 710. Alternatively, the welding wheels 830 may be unequally spaced around the circumference of the wound layer 710. In examples when the welding wheels 830 are equally spaced around the circumference of the wound layer 710, the forces applied to the wound layer 710 by the welding wheels 830 may cancel each other out, and the need for additional external support to support the wound layer 710 as the wound layer 710 travels between the welding wheels 830 may be avoided. In examples when the welding wheels 830 are unequally spaced around the circumference of the wound layer 710, the forces applied to the wound layer 710 by the welding wheels 830 may not cancel each other out, and the need for additional external support to support the wound layer 710 as the wound layer 710 travels between the welding wheels 830 may be avoided.

[0107] At process 906, the outer coil 712 is welded to the inner coil 714 at a plurality of bonding locations (e.g., bonding locations 720) by applying an electric current between the mandrel 810 and the welding wheel 830. The electric current may be applied between the welding wheel 830 and the mandrel 810 at different times while the coil layer 710 is guided between the welding wheel 830. Each time the electric current is applied, a bond 725 (e.g., a spot weld / seam weld) is provided between the outer coil 712 and the inner coil 714, thereby bonding the outer coil 712 and the inner coil 714 together at the bonding location 720. In some examples, the welding wheel 830 is pressed radially inwardly in a direction D2 toward the longitudinal axis A of the coil layer 710. Pressing the welding wheel 830 radially inwardly increases the contact pressure between the welding wheel 830 and the coil layer 710. When electrical current is applied between the welding wheel 830 and the mandrel 810 , the increased contact pressure may create a stronger bond 725 between the outer winding 712 and the inner winding 714 .

[0108] In the following description, specific details describe some examples consistent with the present disclosure. A plurality of specific details are set forth in order to provide a thorough understanding of these examples. However, it is apparent to those skilled in the art that some examples may be implemented without some or all of these specific details. The specific examples disclosed herein are illustrative, rather than restrictive. Those skilled in the art may recognize that other elements within the scope and spirit of the present disclosure, although not specifically described. Additionally, in order to avoid unnecessary repetition, one or more features shown and described in association with an example may be incorporated into other examples, unless specifically described otherwise or if these one or more features make the example inoperative. In some cases, well-known methods, procedures, components and circuits are not described in detail to avoid unnecessarily obscuring the various aspects of these examples.

[0109] In some examples, the components discussed below can be part of a robot-assisted system, as described in further detail below. The robot-assisted system can be applicable to, for example, surgical procedures, robot-assisted surgical procedures, diagnostic procedures, therapeutic procedures, or biopsy procedures. Although some examples of such procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein can be used for animals, human corpses, animal corpses, parts of human or animal anatomical structures, non-surgical diagnostics, and for industrial systems and general robotic systems, general robotic-assisted systems, or robotic medical systems.

[0110] like Fig.12 As shown, the medical system 100 generally includes a manipulator assembly 102 for operating a medical device 104 (e.g., a flexible elongated device 150) to perform various procedures on a patient P positioned on a table T. The manipulator assembly 102 can be a robotic-assisted, non-robotic-assisted, or hybrid robotic-assisted and non-robotic-assisted assembly having selected degrees of freedom of motion that can be motorized and / or robotic-assisted and selected degrees of freedom of motion that can be non-motorized and / or non-robotic-assisted. The medical system 100 can further include a main assembly 106 that generally includes one or more control devices for controlling the manipulator assembly 102. The manipulator assembly 102 supports the medical device 104 and can optionally include a plurality of actuators or motors that drive inputs on the medical device 104 in response to commands from a control system 109. The actuator can optionally include a drive system that, when coupled to the medical device 104, can advance the medical device 104 into a naturally occurring or surgically created anatomical orifice.

[0111] The medical system 100 also includes a display system 110 for displaying images or representations of the surgical site and the medical device 104 generated by the subsystem of the sensor system 108. The display system 110 and the main assembly 106 can be oriented so that the operator O can control the medical device 104 and the main assembly 106 using the perception of the telepresentation. Additional information about the medical system 100 and the medical device 104 can be found in International Application Publication No. WO 2018 / 195216, filed on April 18, 2018, entitled “Graphical User Interface for Monitoring an Image-Guided Procedure” (which is incorporated herein by reference in its entirety).

[0112] In some examples, the medical device 104 may include components of an imaging system (discussed in more detail below), which may include an imaging scope assembly or imaging instrument that records concurrent or real-time images of a surgical site and provides the images to an operator or operator O via one or more displays of the medical system 100 (e.g., one or more displays of the display system 110). The concurrent image may be, for example, a two-dimensional or three-dimensional image captured by an imaging instrument located within the surgical site. In some examples, the imaging system includes an endoscopic imaging instrument component that may be integrally or removably coupled to the medical device 104. However, in some examples, a separate endoscope attached to a separate manipulator assembly may be used with the medical device 104 to image the surgical site. In some examples, as described in detail below, the imaging instrument, alone or in combination with other components of the medical device 104, may include one or more mechanisms for cleaning one or more lenses of the imaging instrument when one or more lenses are partially and / or completely obscured by fluids and / or other substances encountered by the distal end of the imaging instrument. In some examples, one or more cleaning mechanisms may optionally include an air and / or other gas delivery system that can be used to emit a puff of air and / or other gas to blow one or more lenses clean. Examples of one or more cleaning mechanisms are discussed in more detail in International Application Publication No. WO / 2016 / 025465, entitled “Systems and Methods for Cleaning an Endoscopic Instrument”, filed on August 11, 2016; U.S. Patent Application No. 15 / 508,923, entitled “Devices, Systems, and Methods Using Mating Catheter Tips and Tools”, filed on March 5, 2017; and U.S. Patent Application No. 15 / 503,589, entitled “Systems and Methods for Cleaning an Endoscopic Instrument”, filed on February 13, 2017 (each of which is incorporated herein by reference in its entirety). The imaging system may be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors (which may include a processor of the control system 109).

[0113] The control system 109 includes one or more memories and one or more computer processors (not shown) for implementing control between the medical device 104, the main component 106, the sensor system 108, and the display system 110. The control system 109 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement some or all of the methods described according to various aspects disclosed herein, including instructions for providing information to the display system 110.

[0114] Fig.13 is a schematic diagram of a medical device system 200 according to some examples. The medical device system 200 includes an elongated device 202, such as a flexible conduit (e.g., the medical device 104, which may be the flexible elongated device 150), coupled to a drive unit 204. The elongated device 202 includes a flexible body 216 having a proximal end 217 and a distal end or tip portion 218. The medical device system 200 further includes a tracking system 230 for determining a position, orientation, speed, velocity, posture, and / or shape of the distal end 218 and / or one or more segments 224 along the flexible body 216 using one or more sensors and / or imaging devices (described in further detail below).

[0115] Tracking system 230 may optionally use shape sensor 222 to track one or more of distal end 218 and / or segments 224. Shape sensor 222 may optionally include an optical fiber (e.g., provided within an internal channel (not shown) or mounted externally) aligned with flexible body 216. The optical fiber of shape sensor 222 forms a fiber optic bend sensor for determining the shape of flexible body 216. In an alternative, an optical fiber including a fiber Bragg grating (FBG) is used to provide strain measurements in the structure in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in the following patent applications: U.S. Patent Application No. 11 / 180,389, entitled "Fiber Optic Position and Shape Sensing Device and Method Relating Thereto," filed on July 13, 2005; U.S. Patent Application No. 12 / 047,056, entitled "Fiber-Optic Shape and Relative Position Sensing," filed on July 16, 2004; and U.S. Patent No. 6,389,187, entitled "Optical Fiber Bend Sensor," filed on June 17, 1998 (each of which is incorporated herein by reference in its entirety). In some examples, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering. In some examples, other techniques may be used to determine the shape of the elongated device. For example, the history of the distal posture of the flexible body 216 can be used to reconstruct the shape of the flexible body 216 over a period of time. In some examples, tracking system 230 may optionally and / or additionally track distal end 218 using orientation sensor system 220. Orientation sensor system 220 may be a component of an EM sensor system having orientation sensor system 220, which includes one or more conductive coils that may experience an externally generated electromagnetic field. Each coil of the EM sensor system then generates an induced electrical signal, the characteristics of which depend on the orientation and position of the coil relative to the externally generated electromagnetic field. In some examples, orientation sensor system 220 may be configured and positioned to measure six degrees of freedom (e.g., three orientation coordinates X, Y, and Z and three orientation angles of pitch, yaw, and roll indicating a base point) or five degrees of freedom (e.g., three orientation coordinates X, Y, and Z and two orientation angles of pitch and yaw indicating a base point).Further description of orientation sensor systems is provided in U.S. Patent No. 6,380,732, filed August 11, 1999, entitled "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked," which is incorporated herein by reference in its entirety.

[0116] The flexible body 216 includes a channel (not shown) sized and shaped to receive a medical device 226. Further description of a medical device received by the flexible body is provided in U.S. Provisional Patent Application No. 63 / 077,059, filed on September 11, 2020, entitled “Systems for Coupling and Storing an Imaging Instrument,” which is incorporated herein by reference in its entirety.

[0117] The flexible body 216 may also house cables, linkages, or other steering controls (not shown) extending between the drive unit 204 and the distal end 218 to controllably bend the distal end 218 (e.g., as shown by a dashed line depiction 219 of the distal end 218). In some examples, at least four cables are used to provide independent "up and down" steering to control the pitch of the distal end 218 and "side to side" steering to control the yaw of the distal end 218. U.S. Patent Application No. 13 / 274,208, filed on October 14, 2011, entitled "Catheter with Removable Vision Probe," which is incorporated herein by reference in its entirety, describes a steerable elongated device in detail.

[0118] Information from tracking system 230 may be sent to navigation system 232 where it is combined with information from imaging system 231 and / or preoperatively acquired models to provide real-time position information to the operator. In some examples, the real-time position information may be displayed on a Fig.12 on the display system 110 for controlling the medical device system 200. In some examples, Fig.12The control system 109 can use the position information as feedback for positioning the medical instrument system 200. Various systems for registering and displaying surgical instruments and surgical images using fiber optic sensors are provided in U.S. Patent Application No. 13 / 107,562, filed May 13, 2011, entitled “Medical System Providing Dynamic Registration of a Model of an Anatomical Structure for Image-Guided Surgery,” which is incorporated herein by reference in its entirety.

[0119] In some examples, the medical device system 200 Fig.12 The medical system 100 may be robot-assisted. In some examples, Fig.12 The manipulator assembly 102 may be replaced by direct operator control. In some examples, direct operator control may include various handles and operator interfaces for handheld operation of the instrument.

[0120] The singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context indicates otherwise. And the terms "comprises", "comprising", "includes", "has", etc. specify the presence of the described features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts or groups. The components described as being coupled may be directly electrically or mechanically coupled, or they may be indirectly coupled via one or more intermediate components. The components described as being coupled may be directly or indirectly communicatively coupled. The auxiliary verb "may" also means that the features, steps, operations, elements or parts are optional.

[0121] In the description, the specific details describing some examples have been set forth. A plurality of specific details have been set forth in order to provide a thorough understanding of these examples. However, it is apparent to those skilled in the art that some examples may be implemented without some or all of these specific details. The specific examples disclosed herein are intended to be illustrative, not restrictive. Those skilled in the art may recognize other elements that fall within the scope and spirit of the present disclosure, although not specifically described.

[0122] Elements described in detail with reference to one example, embodiment, or application may, whenever feasible, be optionally included in other examples, embodiments, or applications that are not specifically shown or described. For example, if an element is described in detail with reference to one example and not described with reference to a second example, it may still be claimed that the element is included in the second example. Therefore, to avoid unnecessary repetition in the foregoing description, one or more elements shown and described in conjunction with one example, embodiment, or application may be incorporated into other examples, embodiments, or applications unless specifically described otherwise, unless the one or more elements would render the example or embodiment inoperative, or unless two or more of the elements provide conflicting functionality.

[0123] Any changes and further modifications to the described devices, apparatus, methods, and any further applications of the principles of the present disclosure are fully contemplated, as would be normally expected by a person skilled in the art to which the present disclosure relates. Additionally, the dimensions provided herein are for specific examples, and it is contemplated that different sizes, dimensions, and / or ratios may be utilized to implement the concepts of the present disclosure. In order to avoid unnecessary descriptive repetitions, one or more components or actions described according to one illustrative example can be used or omitted when applicable to other illustrative examples. For the sake of brevity, multiple reiterations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used in all drawings to refer to the same or similar components.

[0124] The systems and methods described herein can be applied to navigate and treat anatomical tissue in any of various anatomical systems (including lungs, colon, intestines, kidneys and calyces, brain, heart, circulatory system (including vascular system) and / or similar tissues) via naturally occurring or surgically created connecting channels. Although some examples described herein relate to surgical procedures or instruments, or medical procedures and medical instruments, the disclosed technology is applicable to non-medical procedures and non-medical instruments. For example, the instruments, systems and methods described herein can be used for non-medical purposes, including industrial uses, general robotic uses, and sensing or manipulating non-tissue artifacts. Other example applications relate to cosmetic improvements, imaging of human or animal anatomical structures, collecting data from human or animal anatomical structures, and training medical or non-medical personnel. Additional example applications include the use of procedures for tissues removed from human or animal anatomical structures (without returning to human or animal anatomical structures) and performing procedures on human or animal corpses. In addition, these technologies can also be used for surgical and non-surgical medical treatment or diagnostic procedures.

[0125] Additionally, although some of the examples presented in this disclosure discuss robotically assisted systems or teleoperated systems, the disclosed techniques are also applicable to computer-assisted systems that are partially or fully directly and manually moved by an operator.

[0126] Additionally, one or more elements in the examples of the present disclosure may be implemented in software to be executed on a processor of a computer system such as a control processing system. When implemented in software, each element of the examples of the present disclosure is essentially a coding segment that performs necessary tasks. A program or coding segment can be stored in a processor-readable storage medium (e.g., a non-temporary storage medium) or device, and a processor-readable storage medium or device can be downloaded in the form of a computer data signal embodied in a carrier wave via a transmission medium or a communication link. A processor-readable storage device may include any medium capable of storing information including optical media, semiconductor media, and magnetic media. Examples of processor-readable storage devices include electronic circuits, semiconductor devices, semiconductor storage devices, read-only memories (ROMs), flash memories, erasable programmable read-only memories (EPROMs), floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. The coding segment can be downloaded via a computer network such as the Internet, Ethernet, etc. Any of a variety of centralized or distributed data processing architectures can be used. Programming instructions can be implemented as multiple separate programs or subroutines, which can also be integrated into multiple other aspects of the system described herein. In some examples, the control system may support wireless communication protocols such as Bluetooth, Infrared Data Association (IrDA), HomeRF, IEEE802.11, Digital Enhanced Cordless Telecommunications (DECT), Ultra-Wideband (UWB), ZigBee, and wireless telemetry.

[0127] A computer is a machine that follows programmed instructions to perform mathematical or logical functions on input information to produce processed output information. A computer includes logic units that perform mathematical or logical functions, and memory that stores programmed instructions, input information, and output information. The term "computer" and similar terms such as "processor" or "controller" or "control system" are similar.

[0128] Note that the processes and displays presented may not be inherently related to any particular computer or other device, and that various systems may be used with the program according to the teachings herein. The structures required for the various systems discussed above will appear as elements in the claims. In addition, examples of the present disclosure are not described with reference to any particular programming language. It should be understood that a variety of programming languages ​​may be used to implement the teachings of the present disclosure described herein.

[0129] Although certain illustrative examples of the present disclosure have been described and shown in the drawings, it should be understood that such examples are merely illustrative and not limiting of the broad concepts disclosed, and that the examples of the present disclosure should not be limited to the specific constructions and arrangements shown and described, since various other modifications may occur to those of ordinary skill in the art.

Claims

1. A flexible elongated device comprising: an articulatable distal segment; and a non-articulable proximal section proximal to the articulable distal section, Wherein a distal portion of the non-articulate proximal section has a first bending stiffness and a proximal portion of the non-articulate proximal section has a second bending stiffness, the first bending stiffness being less than the second bending stiffness.

2. A flexible, elongated device according to claim 1, wherein the distal portion of the non-articulate proximal section includes a first subset of joints, the first subset of joints having a first spatial density, and wherein the proximal portion of the non-articulate proximal section includes a second subset of joints, the second subset of joints having a second spatial density, the second spatial density being less than the first spatial density.

3. The flexible, elongated device of claim 2, wherein along an axial length of the flexible, elongated device, the first spatial density is less than the second spatial density.

4. The flexible, elongated device of claim 1 , wherein the non-articulable proximal section comprises a coiled layer comprising: External winding; an inner coil, which is inside the outer coil; and A coupling portion is between the inner winding and the outer winding to couple the inner winding and the outer winding to each other.

5. The flexible elongated device of claim 4, wherein each of the outer winding and the inner winding is a metal winding, and wherein the bond is a weld coupling the inner winding and the outer winding to each other.

6. The flexible elongate device of claim 4, wherein the tape width of each of the outer and inner windings is uniform along the axial length of the winding layer.

7. The flexible elongated device of claim 4, wherein the outer winding comprises a first tape and a second tape, wherein the first tape and the second tape are intertwined.

8. The flexible elongated device of claim 4, wherein the outer winding has a first pitch direction and the inner winding has a second pitch direction opposite to the first pitch direction.

9. The flexible elongated device of claim 4, wherein the outer coil and the inner coil comprise one of a round wire or a flat wire.

10. The flexible elongated device of claim 4, wherein at least one of the outer coil and the inner coil comprises a monofilament filament or a multifilament filament.

11. The flexible elongate device of claim 4, wherein each of the outer winding and the inner winding is of a closed pitch or an open pitch.

12. The flexible elongated device of claim 1, wherein: The non-articulable proximal section includes a coil; the winding at the distal portion of the non-articulatable proximal section comprises a first strap element having a first strap width; and The winding at the proximal portion of the non-articulatable proximal section includes a second strap element having a second strap width that is wider than the first strap width.

13. The flexible, elongated device of claim 1, wherein the non-articulatable proximal section comprises a coiled layer including a plurality of coils including a first coil having a variable band width.

14. The flexible elongated device of claim 13, wherein the plurality of windings in the winding layer further comprises: a second winding having a pitch direction opposite to the pitch direction of the first winding; and a third winding having a pitch direction opposite to the pitch direction of the second winding, wherein the third winding comprises a tape element having a uniform tape width along the axial length of the winding layer, and Wherein the pitch direction of the third winding is equal to the pitch direction of the first winding.

15. A flexible elongated device comprising: A wound layer providing the flexible elongated device with variable bending stiffness along an axial length of the wound layer, the wound layer comprising a plurality of windings, the plurality of windings comprising a first winding, the first winding comprising a tape element having a variable tape width, wherein: In a first region along the axial length of the wound layer having a first bending stiffness, the first tape element of the first winding has a first tape width; and In a second region along the axial length of the wound layer having a second bending stiffness, the second tape element of the first winding has a second tape width wider than the first tape width, wherein the second bending stiffness is higher than the first bending stiffness.

16. The flexible elongate device of claim 15, wherein the plurality of windings in the layer of windings further comprises a second winding.

17. The flexible elongate device of claim 16, wherein the second winding comprises a uniform tape width along an axial length of the winding layer.

18. The flexible elongate device of claim 16, wherein the second winding is a braided winding.

19. The flexible elongated device of claim 16, wherein the plurality of windings in the layer of windings further comprises a third winding.

20. The flexible elongated device of claim 15, wherein adjacent windings of the plurality of windings have opposite pitch directions.

21. The flexible elongate device of claim 19, wherein the third winding comprises a uniform tape width along an axial length of the winding layer.

22. The flexible elongated device of claim 19, wherein: The first winding is within the second winding; and The second winding is within the third winding.

23. The flexible elongated device of claim 16, wherein the first and second windings are joined together at a distal end of the winding layer and at a proximal end of the winding layer.

24. The flexible, elongated device of claim 15, wherein the first region is distal to the second region.

25. The flexible, elongated device of claim 15, wherein the first region is proximal to the second region.

26. The flexible elongate device of claim 15, wherein the tape width of the tape element of the first winding varies in a uniform pattern from the first region to the second region.

27. The flexible elongated device of claim 15, wherein the tape width of the tape element of the first winding varies from the first region to the second region in a non-uniform pattern.

28. The flexible, elongated device of claim 15, wherein the first coil comprises a slitted hypotube.

29. The flexible elongated device of claim 15, wherein the first winding comprises one of a round wire or a flat wire.

30. The flexible, elongated device of claim 15, wherein the first winding comprises one of a monofilament filament or a multifilament filament.

31. The flexible elongated device of claim 15, wherein the first winding is closed pitch.

32. The flexible elongated device of claim 15, wherein the first winding is open pitch.

33. The flexible elongated device of claim 15, further comprising: an inner sheath comprising at least one catheter including a lumen, wherein the inner sheath defines a working lumen configured to receive at least one elongated device, and wherein the wrapping layer surrounds the inner sheath; and An outer sheath surrounds the inner sheath.

34. The flexible elongated device of claim 15, wherein the winding layer further comprises a joint between the first winding and the second winding of the plurality of windings, wherein the joint couples the first winding and the second winding to each other, and wherein: In the first region along the axial length of the wound layer, a first subset of the bonds has a first spatial density; and In the second region along the axial length of the wound layer, the second subset of the bonds has a second spatial density that is higher than the first spatial density.

35. The flexible, elongated device of claim 34, wherein along the axial length of the flexible, elongated device, the first spatial density is higher than the second spatial density.

36. The flexible elongate device of claim 34, wherein the first spatial density is higher than the second spatial density around a circumferential interface defined between the first winding and the second winding.

37. The flexible, elongated device of claim 34, further comprising an articulatable distal section and a non-articulatable proximal section proximal to the articulatable distal section, the non-articulatable proximal section comprising the coiled layer.

38. A flexible, elongated device according to claim 37, wherein the first region is distal to the second region.

39. A flexible, elongated device according to claim 37, wherein the first region is proximal to the second region.

40. A flexible, elongated device according to claim 37, wherein in a third region having a third bending stiffness along the axial length of the winding layer, a third subset of the bonding portions has a third spatial density higher than the second spatial density, wherein the third bending stiffness is higher than the second bending stiffness.

41. The flexible, elongated device of claim 34, wherein each of the first and second windings is a metal winding, and wherein the bond is a weld coupling the first and second windings to each other.

42. A flexible elongated device comprising: a coil layer providing the flexible elongated device with variable bending stiffness along an axial length of the coil layer, the coil layer comprising a plurality of coils, the plurality of coils comprising: A first winding comprising a tape element having a variable tape width, wherein: In a first region along the axial length of the wound layer having a first bending stiffness, the first tape element of the first winding has a first tape width; and a second tape element of the first winding having a second tape width wider than the first tape width in a second region along the axial length of the winding layer having a second bending stiffness, wherein the second bending stiffness is higher than the first bending stiffness; a second winding; and A third winding, wherein adjacent windings of the plurality of windings have opposite pitch directions.

43. The flexible elongate device of claim 42, wherein the second and third windings each comprise a uniform tape width along the axial length of the winding layer.

44. A flexible, elongated device according to claim 42, wherein the first winding is within the second winding, and wherein the second winding is within the third winding.

45. A flexible elongated device comprising: A wound layer providing variable bending stiffness to the flexible elongated device along an axial length of the wound layer, the wound layer comprising: External winding; an inner coil within the outer coil; and a joint portion between the inner winding and the outer winding to couple the inner winding and the outer winding to each other, wherein: In a first region along the axial length of the wound layer having a first bending stiffness, a first subset of the bonds has a first spatial density; and a second subset of the bonds having a second spatial density in a second region along the axial length of the wound layer having a second bending stiffness, wherein the second bending stiffness is higher than the first bending stiffness, The second spatial density is higher than the first spatial density.

46. ​​The flexible, elongated device of claim 45, wherein along the axial length of the flexible, elongated device, the first spatial density is higher than the second spatial density.

47. The flexible, elongated device of claim 45, wherein the first spatial density is higher than the second spatial density around a circumferential interface defined between the inner and outer windings.

48. The flexible, elongated device of claim 45, further comprising an articulatable distal section and a non-articulatable proximal section proximal to the articulatable distal section, the non-articulatable proximal section comprising the coiled layer.

49. A flexible, elongated device according to claim 48, wherein the first region is distal to the second region.

50. A flexible, elongated device according to claim 48, wherein the first region is proximal to the second region.

51. A flexible, elongated device according to claim 48, wherein in a third region having a third bending stiffness along the axial length of the winding layer, a third subset of the bonding portions has a third spatial density higher than the second spatial density, wherein the third bending stiffness is higher than the second bending stiffness.

52. The flexible, elongated device of claim 45, wherein each of the outer winding and the inner winding is a metal winding, and wherein the bond is a weld coupling the inner winding and the outer winding to each other.

53. The flexible, elongated device of claim 45, wherein each of the outer winding and the inner winding is a polymer winding.

54. The flexible elongate device of claim 45, wherein the tape width of each of the outer windings and the inner windings is uniform along the axial length of the winding layer.

55. The flexible elongated device of claim 45, wherein the outer winding comprises a first strap and a second strap, wherein the first strap and the second strap are intertwined.

56. The flexible elongated device of claim 45, wherein the outer windings have a first pitch direction and the inner windings have a second pitch direction opposite the first pitch direction.

57. A flexible, elongated device according to claim 56, wherein the outer winding has a first pitch direction and the inner winding has a second pitch direction that is the same as the first pitch direction.

58. A flexible, elongated device according to claim 45, wherein at least one of the outer coil and the inner coil is a slit hypotube.

59. The flexible, elongated device of claim 45, wherein the outer coil and the inner coil each comprise one of a round wire or a flat wire.

60. The flexible, elongated device of claim 45, wherein at least one of the outer winding and the inner winding comprises a monofilament filament.

61. The flexible, elongated device of claim 45, wherein at least one of the outer coil and the inner coil comprises a multifilament filament.

62. The flexible elongated device of claim 45, wherein each of the outer winding and the inner winding is of closed pitch.

63. The flexible, elongated device of claim 45, wherein each of the outer windings and the inner windings are open pitch.

64. The flexible elongated device of claim 45, further comprising: an inner sheath, wherein the coiled layer surrounds the inner sheath, wherein the inner sheath comprises at least one catheter, the catheter comprising a lumen, and wherein the inner sheath defines a working lumen configured to receive at least one elongated device; and An outer sheath surrounds the inner sheath.

65. The flexible elongated device of claim 45, wherein the inner winding comprises a tape element having a variable tape width, and wherein: In the first region along the axial length of the wound layer, the first tape element of the inner winding has a first tape width; and In the second region along the axial length of the wound layer, the second tape element of the inner winding has a second tape width that is wider than the first tape width.

66. A flexible, elongated device according to claim 65, wherein the outer winding comprises a uniform band width along the axial length of the winding layer.

67. A flexible, elongated device according to claim 65, wherein the outer winding is a braided winding.

68. A flexible, elongated device according to claim 65, wherein the winding layer further comprises an intermediate winding.

69. A flexible, elongated device according to claim 68, wherein the intermediate winding comprises a uniform tape width along the axial length of the winding layer.

70. A flexible elongate device according to claim 69, wherein: The inner coil is within the middle coil; and The intermediate winding is within the outer winding.

71. A flexible, elongated device according to claim 65, wherein the inner winding and the outer winding are joined together at a distal end of the winding layer and at a proximal end of the winding layer.

72. A flexible, elongated device according to claim 65, wherein the tape width of the tape element of the inner coil varies in a uniform pattern from the first region to the second region.

73. A flexible, elongated device according to claim 65, wherein the tape width of the tape element of the inner coil varies from the first region to the second region in a non-uniform pattern.

74. A method comprising: constructing a first winding and a second winding, wherein the first winding includes a tape element having a variable tape width; constructing a wound layer using the first winding and the second winding, wherein in a first region along an axial length of the wound layer having a first bending stiffness, a first tape element of the first winding has a first tape width, and wherein in a second region along the axial length of the wound layer having a second bending stiffness, a second tape element of the first winding has a second tape width wider than the first tape width, wherein the second bending stiffness is higher than the first bending stiffness; and The first winding is joined to the second winding.

75. The method of claim 74, wherein joining the first winding to the second winding comprises welding the first winding to the second winding.

76. The method of claim 74, wherein bonding the first winding to the second winding comprises bonding the first winding to the second winding with an adhesive.

77. The method of claim 74, wherein constructing the first coil comprises laser cutting a tube to create a hypotube.

78. A method comprising: positioning a wound layer of a flexible elongated device about a conductive mandrel, the wound layer comprising an outer winding and an inner winding within the outer winding; guiding the wound layer between a plurality of conductive wheels, the conductive wheels being configured to contact the wound layer; and The outer winding is welded to the inner winding at a plurality of welding locations by applying an electric current between the mandrel and the conductive wheel, wherein: A first subset of the plurality of weld locations has a first spatial density in a first region along an axial length of the wound layer having a first bending stiffness; and A second subset of the plurality of weld locations has a second spatial density in a second region along the axial length of the wound layer having a second bending stiffness that is higher than the first bending stiffness, the second spatial density being higher than the first spatial density.

79. The method of claim 78, further comprising guiding the wound layer between a plurality of guide wheels, the guide wheels being configured to contact the wound layer.

80. The method of claim 78, wherein the conductive wheels are equally spaced around the circumference of the wound layer.

81. The method of claim 78, wherein the conductive wheels are spaced unequally around the circumference of the wound layer.

82. The method of claim 78, wherein welding the outer winding to the inner winding at the plurality of welding locations comprises pressing the conductive wheel radially inward toward a longitudinal axis of the winding layer to increase a contact pressure between the conductive wheel and the winding layer.

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