Patterned Tube

Abstract

To allow a surgeon to bend or otherwise articulate a scope to access a particular target anatomy.SOLUTION: A patterned tube for use with a scope or similar medical device can include at least one flexible section. The at least one flexible section can include a plurality of first cuts having a first thickness, and a plurality of second cuts having a second thickness. Particular ones of the second cuts can be located substantially opposite particular ones of the first cuts. The at least one flexible section can further include a plurality of bending moment transfer portions. Particular ones of the bending moment transfer portions can be located between particular ones of the first cuts and particular ones of the second cuts.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to an articulating section of a medical scope. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 180,278, filed April 27, 2021, the contents of which are incorporated herein by reference in their entirety.

[0003] Highly flexible scopes, such as highly flexible endoscopes, are used for diagnostic and therapeutic medical procedures, for example, procedures inside the human or animal digestive system or inside the abdomen. Portions of the scope, such as the distal end of the scope, can be made highly flexible to allow the surgeon to bend or otherwise articulate the scope to access particular target anatomical structures. Summary of the Invention [Means for solving the problem]

[0004] Endoscopes and other similar surgical scopes or catheters can be used in a variety of surgical procedures, for example, in ear, nose and throat (ENT) procedures such as tonsillectomy, sinus surgery, or other similar procedures, procedures in the digestive system, or procedures inside the abdomen. Catheters can be used in procedures such as inserting a stent or balloon into an artery. Often, during a surgical procedure, it may be desirable for at least a portion of the scope to be articulated so that it is angled (e.g., bent) from a straight zero degree angle to an angle of 15 degrees, 30 degrees, 45 degrees, 90 degrees, 200 degrees, or more. The sheath or tube of the scope or catheter (e.g., hypotube or subcutaneous tube, or other cylindrical or non-cylindrical tube, such as having a particular inner and outer diameter or similar lateral dimensions) can be made of or formed from a highly rigid material, such as surgical grade stainless steel, alloy, or another similar material, that can be made highly flexible and bent or flexed at an angle. Such flexibility may be achieved by forming a series of cuts (e.g., laser cuts) in the tube. Different types of cuts in the tube (e.g., finer or thinner cuts, coarser or wider cuts, or the like) may be utilized, with each type of cut having its particular properties. For example, different types of cuts (e.g., different cut widths) may affect the degree to which the highly flexible portion of the tube can be bent, the amount of torque the tube can sustain, the compressive effect under load, or the like.

[0005] One way to solve these problems is to use a combination of coarse and fine cuts in a portion of the tube or sheath of the scope, i.e., a patterned tube deflectable section of the medical device that can be connected to the scope to be made highly flexible. In an example, the coarse and fine cuts can be alternated to help achieve a large angle of articulation and reduce or minimize the compressive effect of the cuts under load by staying within the highly elastic material property region of the material. The depth, width, length, and number of cuts can be varied to achieve the desired degree of articulation, articulation shape, start of articulation, articulation spread (e.g., the path that the distal tip of the scope travels from a start position to an end or maximum articulation position), etc., of the most distal end of the highly flexible or bendable portion. The main line of the tube can be divided into several regions, segments, or sections, each of which includes several cuts to make that region highly flexible. The cuts can be achieved, for example, by laser cutting a "pattern" into the region of the tube. The cut tube may then be electropolished or otherwise smoothed to help remove any sharp edges and / or jagged edges on the edges of the cuts.

[0006] In the drawings, which are not necessarily drawn to scale, like numbers may describe different views of like components. Like numbers with different letter suffixes may represent different instances of like components. The drawings generally illustrate, by way of example, but not by way of limitation, various embodiments discussed in the present document. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 shows an example of a tube trunk with multiple regions containing alternating fine and coarse cuts. [Figure 2A] 2 is an alternative view of the tube of FIG. 1, including a flattened and enlarged view of the tube in a detailed view of the cuts and the switchback member formed between the cuts. [Figure 2B]2 is an alternative view of the tube of FIG. 1, including a flattened and enlarged view of the tube in a detailed view of the cuts and the switchback member formed between the cuts. [Figure 2C] 2 is an alternative view of the tube of FIG. 1, including a flattened and enlarged view of the tube in a detailed view of the cuts and the switchback member formed between the cuts. [Figure 2D] 2 is an alternative view of the tube of FIG. 1, including a flattened and enlarged view of the tube in a detailed view of the cuts and the switchback member formed between the cuts. [Figure 3A] 13A-13C show examples of tubes with varying numbers of highly flexible sections containing different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. [Figure 3B] 13A-13C show examples of tubes with varying numbers of highly flexible sections containing different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. [Figure 4A] 13A-13C show examples of tubes with varying numbers of highly flexible sections containing different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. [Figure 4B] 13A-13C show examples of tubes with varying numbers of highly flexible sections containing different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. [Figure 5A] 13A-13C show examples of tubes with varying numbers of highly flexible sections containing different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. [Figure 5B] 13A-13C show examples of tubes with varying numbers of highly flexible sections containing different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. [Figure 6] 13A-13C show examples of tubes with opposing open and closed cuts during active articulation. [Figure 7A] FIG. 13 illustrates examples of fine and coarse cut stem articulation. [Figure 7B] FIG. 13 illustrates examples of fine and coarse cut stem articulation. [Figure 8] FIG. 13 shows an example of a tube with a highly flexible section constructed with features positioned at a rotational angle relative to one another. [Figure 9] 13A-13C show examples of fine and coarse cut trunks incorporated into endoscope shaft articulation performance in simulated use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] This document describes, among other things, articulating medical instruments. For example, disclosed herein is a system for hybrid alternating fine and coarse cut articulating sections of a tube for attachment to a medical scope, such as an endoscope. The system includes a tube formed from a solid material (e.g., surgical stainless steel or the like), the tube having an inner diameter and an outer diameter. At least one deflectable or other highly flexible segment or section may be formed within the tube. Each segment may include a plurality of first slits, cuts, or other openings (e.g., coarse cuts) having a first thickness or width, and a plurality of second slits, cuts, or other openings (e.g., fine cuts) having a second thickness or width. In an example, certain of the coarse cuts may be located opposite certain of the fine cuts (e.g., across the tube from certain of the fine cuts) and adjacent to different certain of the fine cuts. The coarse cuts may have a width greater than the opposing fine cuts. For example, the coarse cuts may have a width of 0.015 or 0.016 inches and the fine cuts may have a width of 0.003 inches. The width of either the coarse or fine cuts may be specified at any thickness and separation distance between adjacent cuts desired for the tube or portion of the tube to achieve a particular "bend" angle of articulation.

[0009] Similarly, the tube may have as many highly flexible segments as desired for the particular use, procedure, application, or the like in which the tube is to be implemented. Similarly, each segment may have as many coarse and fine cuts as desired to achieve a direction of articulation (e.g., two-way articulation, four-way articulation, etc.), a particular angle of articulation (e.g., 90 degrees, 260 degrees, 300 degrees, etc.). The coarse cuts and corresponding fine cuts may be formed in the tube such that a switchback member (e.g., a "U-shaped" portion or bend that conforms to or defines the circumference, outer edge, or similar surface of the tube trunk) is formed between each coarse cut and its corresponding fine cut, etc. The switchback member may cause opposing cuts to open or close during articulation of the tube trunk.

[0010] In examples, the incision may be pulled closed using an articulating member such as a cable or wire or "pull wire." In examples, one or more pull wires may be attached (e.g., slidably) or guided inside a portion of the tube (e.g., a wider portion, an outer edge of the inner diameter, or any other interior portion of the tube as desired or preferred). A pull wire attachment may be located on the interior portion of the tube. Such a pull wire attachment may allow an associated pull wire to pass therethrough from the proximal end to the distal end of the tube. This may preferably maintain the position of the pull wire along a highly flexible section to allow deflection or bending of the distal end when the pull wire is retracted by a handle or other pull wire manipulator. There may be as many pull wires as desired for a particular device, depending at least in part on how many times the device is to be deflected or bent. For example, there may be two pull wires on opposing sides for a two-way deflectable device, four pull wires for a four-way deflectable device, etc.

[0011] In an example, during articulation of the trunk, the coarse notches may be pulled closed as the trunk is bent. For example, during articulation, the coarse notches may be "pulled closed" from their neutral thickness or width (e.g., 0.015 inches) to a width or thickness of 0.0077 inches. The bending moment may be transferred through a transmission member (e.g., a central "beam") located within the trunk. For example, the bending moment may be transferred to a switchback member between adjacent coarse notches, adjacent fine notches, or both. This may cause the fine notches to open when the coarse notches are pulled closed. Conversely, when the fine notches are pulled closed, the switchback member may cause the opposing coarse notches to open (e.g., from a neutral thickness or width of 0.015 inches to a width or thickness of 0.019 inches). The fine cuts may be pulled wider open (e.g., from a neutral width of 0.003 inches to a width of 0.0072 inches) or narrower (e.g., from a neutral width of 0.003 inches to a width of 0.0020 inches) depending on how the trunk of the tube is articulated. The starting or neutral width of the coarse or fine cuts may vary at different locations of the tube. Similarly, the width of the cuts that may be biased open or closed during articulation of the trunk may vary. The stiffness of the central beam or other transmission member may also be varied in certain adjacent sections of the trunk to allow for selection of the spread path, adjustment of the intermediate and final positions of the endoscope tip, or the like.

[0012] Forming a switchback member between the coarse and fine cuts can help provide increased articulation capability of the highly flexible portion of the tube, allowing the trunk to have a smaller radius of curvature (versus an uncut stainless steel trunk design) for a given trunk length without inducing plastic deformation. This smaller radius of curvature may be desirable for the endoscope in some applications or procedures to help improve access by the distal portion of the scope to certain parts of the anatomical structure (e.g., the inferior calyx of the kidney).

[0013] The patterned tube for enabling articulation (flexion) may include at least one highly flexible section along at least a portion of the length of the tube, the length of the tube extending from the proximal end of the tube to the distal end of the tube. The highly flexible section may include a plurality of first cuts having a first cut thickness and a plurality of second cuts having a second cut thickness. Certain ones of the second cuts may be located substantially opposite one another across the tube from certain ones of the first cuts. Certain second cuts may be in alignment with certain first cuts or, alternatively, may be offset from certain first cuts. Certain first and second cuts may be separated by a switchback member.

[0014] The tube may further include one or more bending moment transmission members located between adjacent ones of the first cuts and adjacent ones of the second cuts and connecting adjacent switchback members. Each of the one or more bending moment transmission members may include a circumferential portion extending around the circumference of the tube configured to transmit bending moments to a switchback member formed in the tube between a particular one of the first cuts and a particular one of the second cuts. The switchback members may be configured to cause a particular first cut to be either wider or narrower and an opposing particular second cut to be either wider or narrower during articulation of a portion of the tube including the particular first cut and the opposing particular second cut. Stated differently, when the tube is bent or articulated, a switchback member located between the first cut and the second cut may cause one of the cuts to open and the opposing cut to close, or vice versa.

[0015] The tube may further include an articulation member, such as a cable or wire. The articulation member may be attached to an inner portion within an inner lumen of the tube by at least one guide configured to maintain a position of the articulation member along the highly flexible section. Constrained by the at least one guide, the articulation member may help to permit deflection of at least a portion of the highly flexible section when the articulation member is pulled or retracted, such as via a handle, pull wire, or other manipulator.

[0016] The tube may include multiple highly flexible regions, such as a first highly flexible region and a second highly flexible region, e.g., the second highly flexible region is located adjacent to the first highly flexible region. In examples, at least a portion of the second highly flexible region may be constructed with a feature (e.g., a switchback member, a notch, or the like) that is disposed at a rotational angle relative to a similar feature in the first highly flexible region. In examples, the first highly flexible region may be formed from a different material than the second highly flexible region, such that the materials of the first and second highly flexible regions have different flexibilities.

[0017] In an example, the thickness of the tube wall may vary to help provide different amounts of flexibility in different regions of the highly flexible section of the tube. For example, the outer diameter toward or at the distal end of the highly flexible section may be smaller than the outer diameter toward or at the proximal end of the highly flexible section. In this example, the wall thickness of the cylinder may be thinner at the distal end of the highly flexible section relative to the more proximal portion. Such a change in the thickness of the tube wall may be abrupt (e.g., a "step" that changes from a thickness of "x" centimeters or inches to 0.75x centimeters or inches at a certain point) or may include a tapered change where the thickness of the tube wall begins to decrease, linearly or non-linearly, toward the distal end or toward a point near the distal end of the highly flexible section.

[0018] A thinner wall at or toward the distal end may provide additional flexibility of the tube in addition to what the cut pattern may provide. Such a change in thickness may be realized in an integrally molded tube, or a similar change in flexibility may be achieved by forming the tube with two or more segments (e.g., in adjacent sections) of differing flexibility and / or different material composition that are welded or otherwise connected together.

[0019] FIG. 1 is a diagram showing an example of a tube trunk with multiple regions, where certain regions include alternating fine and coarse cuts. FIG. 1 illustrates an example of a patterned tube 100 having a proximal end 102 and a distal end 104. The patterned tube 100 includes a first highly flexible segment 106, a second highly flexible segment 108, a third highly flexible segment 110, a fourth highly flexible segment 112, a fifth highly flexible segment 114, and a sixth highly flexible segment 116. The highly flexible segments 106-116 may extend along at least a portion of the length of the patterned tube 100 from the proximal end 102 to the distal end 104. The highly flexible segments 106-116 may be located substantially adjacent to one another along the length of the patterned tube 100. For example, a first highly flexible segment 106 may be adjacent to a second highly flexible segment 108, which may be adjacent to a third highly flexible segment 110, and so on.

[0020] The highly flexible section 106-116 may include a plurality of (first) coarse cuts 118, 120, 122, 124, and 126 having a first cut thickness, and a plurality of (second) fine cuts 128, 130, 132, 134, and 138 having a second cut thickness. A particular fine cut of the plurality of fine cuts 128-138 may be aligned and positioned substantially opposite across the patterned tube 100 from a particular coarse cut of the plurality of coarse cuts 118-126. For example, the coarse cut 118 and the fine cut 128 may be positioned substantially opposite across the pattern from one another. Similarly, the coarse cut 120 may be positioned substantially opposite across the pattern from the fine cut 130, and so on. Alternatively, a particular fine cut of the plurality of fine cuts 128-138 may be offset from a particular coarse cut of the plurality of coarse cuts 118-126 and positioned across the patterned tube 100. In an example, the patterns of coarse cuts and fine cuts may be formed on opposing sides of a cylinder forming the patterned tube 100 such that on one side of the cylinder, a particular fine cut exists between two particular coarse cuts. The cut cylinder of the patterned tube may be referred to as its cylindrical trunk. For example, as illustrated in FIG. 1, on one side of the tube, cut 118, a particular coarse cut of the plurality of coarse cuts having a first cut thickness, is adjacent to cut 140 having a second cut thickness. Cut 140 having the second cut thickness is again adjacent to cut 120 having the first cut thickness. Similarly, on the opposite side of the cylinder, cuts 142 having the first cut thickness are between cuts 128 and 130, each having a second cut thickness. A similar pattern of cuts may be formed in each of the highly flexible segments.

[0021] 2A-2E are alternative views of the tube of FIG. 1, including a conceptual view of the tube where the cylinder has been conceptually cut lengthwise and "unfolded," flattened, and expanded to provide a more detailed view of the cuts and the switchback members formed between the cuts. FIG. 2A shows the patterned tube 100 of FIG. 1 again, and FIG. 2B illustrates an example of the patterned tube 100 that has been conceptually "unfolded" and flattened so that it is no longer in a three-dimensional cylindrical shape. The unfolded tube 200 includes a second highly flexible segment 108, a Detail A 201A marked with a circle within the second highly flexible segment 108, a fifth highly flexible segment 114, and a Detail B 202A marked with a circle within the fifth highly flexible segment 114. Detail A 201A and Detail B 202A are expanded to a 16:1 scale in FIGS. 2C and 2D, respectively. As illustrated in FIG. 2C, highlighting Detail A 201A, an example width of the coarse cut 206 can be 0.15 inches and an example width of the corresponding fine cut 208 can be 0.003 inches. A switchback member can be formed between opposing first and second cuts. For example, a first switchback member 210 can be formed between the coarse cut 206 and the fine cut 208. Similarly, a second switchback member 214 can be formed adjacent to the first switchback member 210.

[0022] When deployed, the switchback members may be formed in a U-shape (e.g., horseshoe-shaped), although the switchback members may be another or different shape. For example, when deployed, a particular switchback member may be triangular (e.g., "V" shaped), rectangular, octagonal, or any suitable shape to achieve a desired bending force or degree of deflection of each cut between which the switchback member is formed. In an example, the shape of the switchback members in one portion of the patterned tube 100 may be different than in another portion of the patterned tube 100. For example, in the first highly flexible segment 106, the switchback members may be U-shaped (when deployed), while the switchback members in the second highly flexible segment 108 may be triangular (when deployed) and the switchback members in the third highly flexible segment 110 may be rectangular (when deployed). Similarly, the size of the switchback members along the patterned tube 100 (e.g., width, switchback shapes of different radii, etc.) may be selected or varied to help meet the desired degree of deflection of the fine and coarse cuts.

[0023] The cut patterns described above may result in adjacent switchback members being offset and oriented opposite one another. For example, the deployed U-shaped "bend" of the first switchback member 210 may be oriented in an opposite direction (e.g., face, point, etc.) from that of the second switchback member 214, such that when the patterned tube 100 is "deployed" and flattened as illustrated in FIG. 2B, the first switchback member 210 may appear to be concave up and the second switchback member 214 may appear to be concave down. In another example, the distance or length of the cut into the switchback segment may be determined or specified to control the flexibility at that point. For example, the "end" of the fine cut 216 in FIG. 2D may be "y" units to the "end" of the portion of the switchback member 220 that is concave down. Thus, to adjust the flexibility of the switchback member 220, the distance "y" can be modified so that the end of the notch 216 is closer to the "tip" of the concave downward portion of the switchback member 220 (resulting in a longer "length" of the notch 216). The longer the notch 216 is made into the switchback member 220, the greater the amount of flexibility of the patterned tube 100 in the switchback member 220.

[0024] The bending moment transfer members 212 may be located between adjacent coarse notches and adjacent fine notches to connect adjacent switchback members, such as first switchback member 210 and second switchback member 214. The bending moment transfer members 212 may include, for example, a circumferential portion extending around the circumference of the patterned tube 100 and may be configured to transfer bending moments to the switchback members, for example, to the first switchback member 210 and / or the second switchback member 214.

[0025] In an example, the thickness or width of a particular rough cut may vary along the length of the patterned tube 100. For example, without bending, the rough cut 206 located in the second highly flexible segment 108 of the patterned tube 100 may have a neutral thickness or width of 0.015 inches, as illustrated in FIG. 2C, and the rough cut 218 located in the fifth highly flexible segment 114 may have a neutral thickness or width of 0.016 inches, as illustrated in FIG. 2D. This may result in the size of the bending moment transfer members between adjacent switchback members, as well as the width of the switchback members, being varied at different portions along the patterned tube 100. For example, in FIG. 2C, the width of one "side" of the switchback member 214 is 0.010 inches, while in FIG. 2D, the width of one "side" of the switchback member 222 is 0.009 inches.

[0026] In an example, as illustrated in FIG. 2D illustrating the expanded portion 200D of the deployed tube 200, the coarse cuts may vary in width along the length of the tube. For example, the coarse cuts may be wider or thicker when encountered in a direction from the proximal end to the distal end. As illustrated in the expanded portion 200D, coarse cut 232 is wider than coarse cut 230, which is wider than coarse cut 228, etc. It should also be understood that the opposing fine cuts may be made wider in a similar manner or procedure as the coarse cuts, or the fine cuts may maintain the same width along the length of the highly flexible segment and / or the length of the tube. Thus, in such an example, the more distal the portion of the highly flexible zone, the larger the width of the "gap" or opening of the coarse cuts, and thus, more articulation may be achieved. Stated differently, the distal portion of the highly flexible section may deflect more, or to a greater angle, than the proximal end of the highly flexible section. This may allow the distal portion to bend sharper, allowing the scope to contact more difficult to reach areas of the anatomy, such as the inferior cupule of the kidney.

[0027] In such examples where the width of the cuts varies or changes from the proximal to the distal end of the highly flexible section, the change can be gradual (e.g., a linear change in gap size from the first cut at the proximal end to the "nth" cut at the distal end, or a non-linear (e.g., exponential) change), or more gradual. In another example, the change can be abrupt, such as a sudden switch from a uniform first gap size to a larger second gap size. The gap sizes of the coarse and / or fine cuts can vary in any pattern, such as the gap size of one or more of the cuts in the distal portion being wider than the gap size of one or more of the cuts in the proximal portion.

[0028] In examples, at least a portion of a particular coarse cut or a particular fine cut may be tapered to accommodate a particular switchback member. For example, as shown in close-up portion 200D, coarse cuts 224, 226, 228, 230, and 232 may include a tapered portion, such as tapered portion 234 in cut 224, or tapered portion 236 in cut 226. The amount of tapering may depend on the width of the cut in which the taper is included.

[0029] 3A-5B illustrate examples of tubes with various numbers of highly flexible sections including different numbers of cuts, different cut widths, and different numbers of wire guides to achieve different angles of articulation. 3A, 4A, and 5A show top views of the respective tubes, while 3B, 4B, and 5B show side views of each tube. 3A-5B illustrate different representative embodiments of tubes with highly flexible sections of different lengths and numbers of cuts, different spacing between the highly flexible sections, and different placements and numbers of wire guide positions. FIG. 3A illustrates an example of a tube 300A with a total length of 2.672 inches and five highly flexible sections 302A, 304A, 306A, 308A, and 310A. The first highly flexible section 302 may include a total of 15 coarse and / or fine cuts (as described above) and spans 0.392 inches. In the first highly flexible region 302, the width of the fine cuts may vary from 0.003 inches to 0.025 inches. The distance between the cuts (and therefore the width of the "beam" between the cuts) may be 0.011 inches.

[0030] The second highly flexible region 304A may be 0.382 inches in length and may include 17 cuts. Additionally, the size of the switchback member (e.g., width when viewed from above the tube 300A) may be 0.0344 inches. The second highly flexible region 304A may include a total of 17 cuts and span a length of 0.384 inches. The third highly flexible region 306A may include a total of 18 cuts and span a length of 0.408 inches. In the third highly flexible region 306A, the distance between the fine cuts (and therefore the width of the central beam between the cuts) may range from 0.009 inches to 0.021 inches. The fourth highly flexible region 308A may include 18 cuts and span 0.408 inches of the tube 300A. The fifth highly flexible section 310A of the tube 300A may include 14 notches and span a length of 0.364 inches. Similar to the dimensions of the notches in the first highly flexible section 302, in the fifth highly flexible section 310 the notch width may vary from 0.003 inches to 0.025 inches and the beam width (or distance between notches) may be 0.011 inches.

[0031] 3A and 3B, adjacent to the highly flexible sections 302A-310A and 302B-310B there may be articulating member wire guide locations 312A-322A and 312B-322B. The wire guide locations 312-322 may be "thicker" portions of the tubes 300A, 300B (e.g., portions of the tubes 300A, 300B with fewer or no notches) that separate the highly flexible sections 302-310 to allow eyelets, loops, rings, or the like to be positioned inside the tubes 300A, 300B to allow articulating members, such as pull wires, to be positioned inside the tubes 300A, 300B. The wire guide locations 312A-322A and 312B-322B can hold the articulating members in place along the inner diameter of the tubes 300A, 300B such that when the articulating members are pulled, the highly flexible sections 312A-322A and 302B-310B can bend or deflect the distal ends of the tubes 300A, 300B in the direction the articulating members are being pulled. As illustrated in FIG. 3B, the wire guide location 322B located toward the distal end of the tube 300B can be located a distance from the tip of the tube 300B, such as 0.140 inches from the end of the tube 300B. The dimensions illustrated in FIG. 3A and FIG. 3B can allow for an articulation angle of 263 degrees (e.g., at the distal ends of the tubes 300A, 300B). In such an example, bending or articulation may begin in the middle three sections, second highly flexible section 304A, third highly flexible section 306A, and fifth highly flexible section 308A, which totals 53 cuts and spans 1.344 inches of tube 300A.

[0032] As illustrated in FIGS. 4A and 4B, the length of the tubes 400A, 400B (3.00 inches) may be longer than the example illustrated in FIGS. 3A and 3B. Additionally, the tubes 400A, 400B may include six highly flexible regions 402A-412A and 402B-412B. The first highly flexible region 402A and the second highly flexible region 404A may each include 16 cuts and be 0.360 inches long. The third highly flexible region 406A may also include 16 cuts, but be 0.384 inches long. The fourth highly flexible region 408A, the fifth highly flexible region 410A, and the sixth highly flexible region 412A may all include 14 cuts and be 0.364 inches long. Such a configuration can essentially "split" or separate the tube 300A into two main portions, a portion including the first highly flexible area 402A, the second highly flexible area 404A, and the third highly flexible area 406A, which includes 49 cuts and spans 1.248 inches, and a second portion including the fourth highly flexible area 408A, the fifth highly flexible area 410A, and the sixth highly flexible area 412A, which includes 42 cuts and spans 1.260 inches. As shown in FIG. 4A, the cut widths can vary from 0.021 inches between fine cuts in the second highly flexible area 404A, and 0.025 between fine cuts in the fifth highly flexible area 410A, etc. Similarly, the beam width between the notches can vary, such as 0.009 inches in the second highly flexible region 404A and 0.011 inches in the fifth highly flexible region 410A.

[0033] As also illustrated in FIG. 4A, the size of the switchback members (as discussed above with respect to FIG. 3A) may vary along the length of the tube 400A (e.g., within the different highly flexible regions). For example, in the first highly flexible region 402A, the size of the switchback members may be 0.0315 inches. In the second highly flexible region 404A, the size of the switchback members may be 0.0344 inches, in the third highly flexible region 406A, 0.072 inches, in the fourth highly flexible region 408A, 0.0315 inches, in the fifth highly flexible region 410A, 0.0344 inches, and in the sixth highly flexible region 412A, 0.0372 inches. The width of the notches in each section may be uniform or may vary as discussed above. Tubes 400A, 400B may include seven wire guide locations 414A-426A and 414B-426B, with the most distal wire guide locations 426A, 426B located 0.138 inches away from the tips of tubes 400A, 400B. The dimensions illustrated in Figures 4A and 4B may allow for an articulation angle of 292 degrees (e.g., at the distal ends of tubes 400A, 400B).

[0034] 5A and 5B illustrate a representative trunk of tubes 500A, 500B that spans 3.118 inches. Instead of having deflectable or highly flexible sections as illustrated in FIGS. 3 and 4, tubes 500A, 500B have a trunk that is highly flexible along the entire length along which the switchback members are formed. Different portions of tubes 500A, 500B can be made to have different amounts of flexibility by varying the size, cut width (and therefore center beam width) of the switchback members in different portions of 500A, 500B. As illustrated in FIG. 5A, tube 500A can have cuts in a pattern such that there are adjacent switchback members that span 2.772 inches of the length of tube 500A. In an example, first portion 506 of tube 500A may include 10 notches and span 531 inches, and second portion 508 of tube 500A may include 11 notches and span 0.678 inches. In second portion 508, the edges of the switchback members may be 0.047 inches, the width of the center beam joining adjacent switchback members may be 0.024 inches, and the notch width of the notches forming the switchback members may be 0.012 inches.

[0035] More distally, tube 500A may include a third section 510 that includes eight notches and spans 0.536 inches, and a fourth section 512 that includes eight notches and spans 0.536 inches. In fourth section 512, the edges of the switchback members may be 0.064 inches, the width of the central beam joining adjacent switchback members may be 0.032 inches, and the notch width of the notches forming the switchback members may be 0.012 inches. The dimensions of the switchback member edges, width of the central beam, and notch width may be uniform or varied as needed to achieve the desired degree of deflection of tubes 500A, 500B.

[0036] 5B illustrates the tube of FIG. 5A rotated to show a side view. As illustrated in FIG. 5B, tube 500B can include articulating members or wire guide locations 514, 516, 518, and 520.

[0037] As illustrated in the examples of Figures 3A-5B, the tube may have any number of highly flexible portions or sections, any size switchback members, any cut width, or any number of wire guide positions, as desired or needed. For example, the tube may include five, six, or seven wire guide positions, may have cut widths of 0.003 inches, 0.0025 inches, 0.0032 inches, and may have cut areas with different amounts of cuts and different beam widths in each of the proximal, distal, or central sections of the tube. For example, the tube may have 14 cuts in the proximal section with a beam width of 0.011 inches, one or more central section sections with 17 or 18 cuts and a beam width of 0.009 inches, and a distal section with 15 cuts and a beam width of 0.011 inches.

[0038] In an example, a tube may have a proximal portion with 14 or 15 notches and a beam width of 0.011 inches, and a distal portion with 17 or 18 notches and a beam width of 0.009 inches. In an example, a tube may have a proximal portion with 14 notches and a beam width of 0.011 inches, and a distal portion with 16 or 17 notches and a beam width of 0.009 inches. In an example, another tube may have a proximal portion with 12 notches and a beam width of 0.011 inches, a central section with 13 or 14 notches and a beam width of 0.009 inches, and a distal portion with 12 notches and a beam width of 0.011 inches. In an example, a tube may have a proximal portion with 14 notches and a beam width of 0.011 inches, and a distal portion with 16 notches and a beam width of 0.009 inches. The tube may be formed with multiple proximal, central, and distal portions as desired, and the cut width, beam width, switchback member shape and / or dimensions, and wire guide position may be any of those described in the various examples discussed above, or any combination thereof.

[0039] FIG. 6 is a diagram showing an example of a tube with open cuts and opposing closed cuts during active articulation. FIG. 6 illustrates an example of a tube 600 with alternating coarse and fine cut patterns such as those discussed above. As illustrated in FIG. 6, an articulating member 602, such as a wire or cable, may be located along an inner portion of the tube 600 such that when the articulating member 602 is pulled or otherwise engaged, the coarse cuts 604 are pulled or articulated to a width of 0.0077 inches, a narrower width compared to the neutral cut thickness, and the fine cuts 608 adjacent the coarse cuts 604 are pulled to a width of 0.0020 inches, which may be narrower than its neutral thickness. On the opposite side of the tube 600 cylinder, the fine cuts 606 opposite the coarse cuts 604 may be bent or articulated to a wider thickness (e.g., 0.0072 inches) compared to its neutral starting thickness in the absence of bending. Similarly, a coarse cut 610 adjacent to a fine cut 606 may be articulated to a wider thickness (eg, 0.0191 inches) compared to its neutral or starting thickness in the absence of flexion.

[0040] Pulling or manipulating articulation members 602 may cause different portions of tube 600 to bend at different angles, such as those illustrated in Figure 6. For example, smaller portions of tube 600 may bend at smaller angles (e.g., 3.93 degrees, 3.83 degrees, etc.), while larger portions of tube 600 may bend at larger angles, such as 9.37 degrees.

[0041] Generally, the wider the neutral cut width of the coarse cuts, the more material is displaced when the tube is deflected or bent. This results in a "steeper" bend, allowing the fine cuts to expand (widen) and provide some "flexibility", allowing the coarse cuts to contract towards each other during the bending motion. The tubes described herein may be designed to reach target portions of anatomical structures such as the kidney calyx, including the inferior calyx, which may involve a sharp, forceful rotation of the tube for the scope to reach such anatomical structures. Thus, as discussed above, different tubes may be designed with different dimensions, such as different size cut widths, different numbers of cuts, or the like, so that the articulation or high flexibility section can bend at angles greater than 180 degrees (e.g., 250 degrees, 270 degrees, 300 degrees, or more).

[0042] 7A and 7B illustrate examples of fine / coarse cut trunk articulation. As illustrated in FIG. 7A and 7B, an articulating trunk 700 (e.g., a deflectable trunk, articulation tube, etc.) with an alternating coarse cut / fine cut pattern such as those described above may be attached to a non-articulating solid or more rigid member 702 such as a scope, handle, or the like. The articulating trunk 700 may be bent in such a manner that the tip 704 of the articulating trunk 700 may be bent from a straight position (180 degree angle) to an angle of greater than 270 degrees as illustrated in FIG. 7A, to an angle of greater than 300 degrees as illustrated in FIG. 7B.

[0043] FIG. 8 illustrates an example of a tube with highly flexible regions constructed with features arranged at a rotational angle relative to one another. FIG. 8 illustrates a patterned tube 800 similar to that illustrated in FIG. 1 with multiple highly flexible regions 802-812. FIG. 8 again shows a "top-down" view of the patterned tube 800. In the example illustrated in FIG. 8, at least a portion of the second highly flexible region 804 may be constructed with features arranged at a rotational angle relative to the first highly flexible region 802. For example, one or more of the switchback members in the second highly flexible region 804 may be arranged at a rotational angle (e.g., 90 degrees, 180 degrees, or the like) relative to the switchback members in the first highly flexible region 802. In such an example, the switchback members in the second highly flexible region 804 may be positioned such that they are on one side of the patterned tube 800 cylinder when viewed from above the switchback members in the first highly flexible region 802.

[0044] Such a pattern may repeat throughout the length of the patterned tube 800. For example, the third highly flexible region 806 and the fifth highly flexible region 810 may have the same orientation as the first highly flexible region 802, while the fourth highly flexible region 808 and the sixth highly flexible region 812 may have the same orientation as the second highly flexible region 804. In such an example, each adjacent region will have features that are rotated relative to or offset from one another.

[0045] This may allow the patterned tube 800 to behave like a laser-cut helical spring and may allow the patterned tube 800 to be deflected in two separate planes (e.g., planes oriented perpendicular to one another). Those sections within the same 90-degree line (e.g., first highly flexible section 802, third highly flexible section 806, and fifth highly flexible section 810) may be bent or deflected in a first plane, while other sections (second highly flexible section 804, fourth highly flexible section 808, and sixth highly flexible section 812) may bend in a second plane. Additionally or alternatively, adjacent switchback members within the same highly flexible section may be rotated relative to one another such that a portion of each highly flexible section may be deflected in a separate plane.

[0046] FIG. 9 illustrates an example of fine / coarse cut trunks incorporated into an endoscope shaft articulation performance in a simulated use. As illustrated in FIG. 9, an endoscope 900 with trunks employing an alternating cut pattern such as those described herein is illustrated for use on a model portion of an anatomical structure 902. The model portion of the anatomical structure 902 may represent a portion of a human anatomical structure, such as a kidney calyx, into which the endoscope 900 may be inserted during a medical procedure such as kidney stone ablation. In the example of FIG. 9, the model portion of the anatomical structure 902 includes a cavity 904 within which a stone, tumor, or the like may form. The tip of the endoscope 900 may be manipulated or bent around a piece of tissue represented by a rectangular shaped area of ​​the model portion of the anatomical structure 902 such that a procedure such as stone ablation may be performed within the cavity 904 by emitting laser radiation from the tip of the endoscope 900.

[0047] Further Description and Examples Example 1 is a patterned tube that enables articulation of a medical scope, the patterned tube comprising at least one highly flexible region between a proximal end of the patterned tube and a distal end of the patterned tube, the at least one highly flexible region including a plurality of first notches having a first notch thickness, a plurality of second notches having a second notch thickness, certain of the second notches being located substantially opposite across the patterned tube from certain of the first notches and separated therefrom by a switchback member, and one or more bending moment transmission members, certain of the one or more bending moment transmission members being located between adjacent certain of the first notches and further between adjacent certain of the second notches and connecting adjacent switchback members.

[0048] In Example 2, the subject matter of Example 1 optionally includes one or more bending moment transmission members each including a circumferential portion extending around an outer periphery of the patterned tube and configured to transmit a bending moment to a switchback member formed in the patterned tube between certain ones of the first notches and certain ones of the second notches.

[0049] In Example 3, the subject matter of Example 2 optionally includes that the switchback member is configured to cause a particular first notch to be one of wider or narrower and an opposing particular second notch to be the other of wider or narrower during articulation of a portion of the patterned tube that includes the particular first notch and the opposing particular second notch.

[0050] In Example 4, the subject matter of Example 3 optionally includes an articulating member attached to an inner portion of the patterned tube.

[0051] In Example 5, the subject matter of Example 4 optionally includes, wherein the articulation member is attached to an inner portion of the patterned tube by at least one guide configured to maintain a position of the articulation member along the highly flexible region and to allow deflection of at least a portion of the highly flexible region when the articulation member is retracted by the manipulator.

[0052] In Example 6, the subject matter of any one or more of Examples 4-5 optionally includes, wherein the articulating members include cables or wires.

[0053] In Example 7, the subject matter of any one or more of Examples 1-6 optionally includes, wherein a neutral thickness of the plurality of first notches and a neutral thickness of the plurality of second notches vary along at least a portion of the at least one highly flexible region.

[0054] In Example 8, the subject matter of Example 7 optionally includes, in a neutral state, a particular first notch at a distal end of the highly flexible region is wider than a particular first notch at a proximal end of the highly flexible region.

[0055] In Example 9, the subject matter of any one or more of Examples 7-8 optionally includes, in a neutral state, a particular second notch at a distal end of the highly flexible region is wider than a particular second notch at a proximal end of the highly flexible region.

[0056] In Example 10, the subject matter of any one or more of Examples 1-9 optionally includes a first highly flexible area and a second highly flexible area located adjacent to the first highly flexible area.

[0057] In Example 11, the subject matter of Example 10 optionally includes that at least a portion of the second highly flexible region is constructed with at least one notch that is positioned at a rotational angle relative to at least one notch in the first highly flexible region.

[0058] In Example 12, the subject matter of any one or more of Examples 10-11 optionally includes, wherein the first highly flexible region is formed from a different material than the second highly flexible region.

[0059] In Example 13, the subject matter of Example 12 optionally includes, wherein the material of the first highly flexible region and the material of the second highly flexible region have different flexibilities.

[0060] In Example 14, the subject matter of any one or more of Examples 1-13 optionally includes, wherein an outer diameter of the patterned tube at a distal end of the patterned tube is smaller than an outer diameter of the patterned tube at a proximal end of the patterned tube.

[0061] In Example 15, the subject matter of any one or more of Examples 1-14 optionally includes at least a portion of the specific first notch or at least one of the specific second notches being tapered to accommodate a specific switchback member located within at least a portion thereof.

[0062] Example 16 is a patterned tube for enabling articulation of a medical scope, the tube comprising a first highly flexible region and a second highly flexible region located adjacent to the first highly flexible region, the first and second highly flexible regions including a plurality of first notches having a first notch thickness, a plurality of second notches having a second notch thickness, certain of the second notches located substantially opposite ones of the first notches across the tube laterally from certain of the first notches and separated from certain of the first notches by switchback members, and one or more bending moment transmission members, certain of the one or more bending moment transmission members located between adjacent ones of the first notches and further between adjacent ones of the second notches and connecting adjacent switchback members.

[0063] In Example 17, the subject matter of Example 16 optionally includes, wherein a neutral thickness of the plurality of first notches and a neutral thickness of the plurality of second notches vary along at least a portion of at least one of the first highly flexible area or the second highly flexible area.

[0064] In Example 18, the subject matter of Example 17 optionally includes, in a neutral state, at least one of a specific first notch at a distal end of the first highly flexible region being wider than a specific first notch at a proximal end of the first highly flexible region, or a specific second notch at a distal end of the first highly flexible region being wider than a specific second notch at a proximal end of the first highly flexible region.

[0065] In Example 19, the subject matter of any one or more of Examples 17-18 optionally includes at least one of: in a neutral state, a specific first notch at a distal end of the second highly flexible region is wider than a specific first notch at a proximal end of the second highly flexible region; or a specific second notch at a distal end of the second highly flexible region is wider than a specific second notch at a proximal end of the second highly flexible region.

[0066] Example 20 is a patterned deflectable portion of a medical device shaft, the deflectable portion comprising a first highly flexible region, a second highly flexible region located adjacent to the first highly flexible region, and an articulation member attached to an inner portion of the deflectable portion by at least one guide configured to maintain a position of the articulation member along the highly flexible region and to allow deflection of at least a portion of the highly flexible region when the articulation member is retracted by an actuator, the first highly flexible region and the second highly flexible region being configured to be aligned with a first notch. the second notches having a thickness, a plurality of first notches having a second notch thickness, certain of the second notches being located substantially opposite, laterally across the deflectable portion from certain of the first notches and separated therefrom by a switchback member, and one or more bending moment transmission members, certain of the one or more bending moment transmission members being located between adjacent certain of the first notches and further between adjacent certain of the second notches connecting the adjacent switchback members.

[0067] In Example 21, the subject matter of Example 20 optionally includes at least one of: in a neutral state, a specific first notch at a distal end of the first highly flexible region is wider than a specific first notch at a proximal end of the first highly flexible region; a specific second notch at a distal end of the first highly flexible region is wider than a specific second notch at a proximal end of the first highly flexible region; a specific first notch at a distal end of the second highly flexible region is wider than a specific first notch at a proximal end of the second highly flexible region; or a specific second notch at a distal end of the second highly flexible region is wider than a specific second notch at a proximal end of the second highly flexible region.

[0068] In Example 22, the subject matter of any one or more of Examples 20-21 optionally includes, at least a portion of the second highly flexible region is constructed with at least one notch disposed at a rotational angle relative to at least one notch in the first highly flexible region, and the first highly flexible region is formed from a different material than the second highly flexible region.

[0069] All publications, patents, and patent documents referred to in this document are incorporated herein by reference in their entirety as if individually incorporated by reference. In the event of any inconsistent usage between this document and those documents incorporated by reference, the usage in the incorporated references shall be considered supplementary to this document, and in the event of irreconcilable inconsistencies, the usage in this document shall control.

[0070] In this document, the terms "a" or "an" are used to include one or more, as is common in patent documents, independent of any other instance or use of "at least one" or "one or more." In this document, the term "or" is used to refer to a non-exclusive or, unless otherwise stated, such that "A or B" includes "A but not B," "B but not A," and "A and B." In the appended claims, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein." Also, in the following claims, the terms "including" and "comprising" are open-ended, i.e., a system, device, article, or process that includes elements in addition to those recited preceding such terms in a claim will still be considered to fall within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels and are not intended to impose numerical requirements on their objects.

[0071] The above description is intended to be illustrative, not limiting. For example, the above described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, for example, by those skilled in the art upon reviewing the above description. The Abstract is submitted to enable the reader to quickly ascertain the nature of the technical disclosure, with the understanding that the Abstract will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to simplify the disclosure. This should not be construed as an intention that an unclaimed disclosed feature is essential to any claim. Rather, the subject matter of the invention may reside in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the embodiments should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. 1. A patterned tube for enabling articulation of a medical scope, the patterned tube comprising: a flexible trunk located between a proximal end of the patterned tube and a distal end of the patterned tube, the flexible trunk comprising: a series of alternating transverse notches spaced apart along the length thereof; Adjacent cuts in the series of cuts are separated by a bending moment transmitting member located between the cuts; a first end of the bending moment transfer member is connected to a first switchback member that extends around the closed end of the first cut; A patterned tube, wherein a second end of the bending moment transfer member is connected to a second switchback member that extends around a closed end of a second notch adjacent the first notch.

2. 2. The patterned tube of claim 1, A patterned tube, wherein the flexibility of the flexible trunk varies along a length of the patterned tube based on variations in at least one of the sizes of one or more particular switchback members, the width of the bending moment transmission members, or the width of particular ones of the series of notches.

3. 3. The patterned tube of claim 2, A patterned tube, wherein a first portion of the flexible trunk has a different flexibility than a second portion of the flexible trunk.

4. 4. The patterned tube of claim 3, A patterned tube, wherein the first portion of the flexible trunk includes one or more particular switchback members that are different in size from one or more particular switchback members of the second portion of the flexible trunk.

5. 4. The patterned tube of claim 3, A patterned tube, wherein the first portion of the flexible trunk includes one or more particular cuts having a different neutral thickness than one or more particular cuts in the second portion of the flexible trunk.

6. 4. The patterned tube of claim 3, A patterned tube, wherein in a neutral state, one or more particular cuts in the first portion are wider than one or more particular cuts in the second portion.

7. 4. The patterned tube of claim 3, A patterned tube, wherein in a neutral state, one or more particular cuts in the first portion are narrower than one or more particular cuts in the second portion.

8. 2. The patterned tube of claim 1, The patterned tube further comprising an articulation member attached to an interior portion of the patterned tube.

9. 9. The patterned tube of claim 8, wherein the articulation members are attached to the inner portion of the patterned tube by at least one guide configured to maintain a position of the articulation members along the flexible trunk and to allow deflection of the flexible trunk when the articulation members are retracted by an actuator, the articulation members comprising cables or wires.

10. A patterned tube that allows articulation of a medical scope, the patterned tube comprising: an articulation member attached to an inner portion of the patterned tube; a flexible trunk located between a proximal end of the patterned tube and a distal end of the patterned tube, the flexible trunk having a degree of flexibility that varies along a length of the patterned tube; and the flexible trunk comprises: a series of alternating transverse notches spaced apart along the length thereof; Adjacent cuts in the series of cuts are separated by a bending moment transmitting member located between the cuts; a first end of the bending moment transfer member is connected to a first switchback member that extends around the closed end of the first cut; A patterned tube, wherein a second end of the bending moment transfer member is connected to a second switchback member that extends around a closed end of a second notch adjacent the first notch.

11. 11. The patterned tube of claim 10, a first portion of the flexible trunk having a different flexibility than a second portion of the flexible trunk; A patterned tube, wherein the articulation member is attached to the inner portion of the patterned tube by at least one guide configured to maintain a position of the articulation member along the flexible trunk and to allow deflection of the flexible trunk when the articulation member is retracted by an actuator, the articulation member comprising a cable or wire.

12. 12. The patterned tube of claim 11, A patterned tube, wherein the first portion of the flexible trunk includes one or more particular switchback members that are different in size from one or more particular switchback members of the second portion of the flexible trunk.

13. 12. The patterned tube of claim 11, A patterned tube, wherein the first portion of the flexible trunk includes one or more particular cuts having a different neutral thickness than one or more particular cuts in the second portion of the flexible trunk.

14. 12. The patterned tube of claim 11, A patterned tube, wherein in a neutral state, one or more particular cuts in the first portion are wider than one or more particular cuts in the second portion.

15. 12. The patterned tube of claim 11, A patterned tube, wherein in a neutral state, one or more particular cuts in the first portion are narrower than one or more particular cuts in the second portion.

16. 11. The patterned tube of claim 10, A patterned tube, wherein the flexibility varies based on variations in at least one of the following: size of one or more particular switchback members, width of the bending moment transmission members, or width of particular notches in the series of notches.

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