Joint movement medical devices

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 the articulation area of a medical scope.

Background Art

[0002] Cross - reference to related applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 180,278, filed on April 27, 2021, the content of which is incorporated herein by reference in its entirety.

[0003] High - flexibility scopes, such as high - flexibility endoscopes, are used for diagnostic and therapeutic medical procedures, for example, procedures inside the digestive system or inside the abdomen of a human or animal. Parts of the scope, such as the distal end of the scope, can be made highly flexible so that a surgeon can bend or otherwise articulate the scope to access a particular target anatomical structure.

Summary of the Invention

Means for Solving the Problems

[0004] Endoscopes and other similar surgical scopes or catheters may be used in a variety of surgical procedures, such as ENT procedures, gastrointestinal procedures, or internal abdominal procedures, including tonsillectomy, sinus surgery, or other similar procedures. Catheters may be used in procedures such as inserting stents or balloons into arteries. Often, it may be desirable that at least a portion of the scope be articulated so as to be angled (e.g., bent) from a straight zero degree to angles such as 15, 30, 45, 90, 200 degrees, or more during a surgical procedure. The sheath or tube of the scope or catheter (e.g., hypotube or subcutaneous tube, or other cylindrical or non-cylindrical tubes, such as those with specific inner and outer diameters or similar transverse dimensions) may be made of or formed from a highly rigid material such as surgical-grade stainless steel, alloy, or other similar material, which is highly flexible and can bend or bent at angles. Such flexibility can be achieved by forming a series of notches (e.g., laser cuts) within the tube. Different types of notches within the tube (e.g., finer or thinner notches, coarser or wider notches, or similar) may be used, each type of notch having its own specific characteristics. For example, different types of notches (e.g., different notch widths) may affect the degree to which the highly flexible portion of the tube can bend, the amount of torque the tube can maintain, the compression effect under load, or similar.

[0005] One way to solve these problems is to use a combination of coarse and fine notches in a portion of the scope's tube or sheath, i.e., in a patterned tubular deflection area of ​​a medical device that may be connected to a scope to be made highly flexible. In example, coarse and fine notches may be alternating to help achieve large-angle joint movements and to reduce or minimize the compressive effect of the notches under load by remaining within the high-elasticity material property region of the material. The depth, width, length, and number of notches may vary to achieve the desired degree of joint movement, joint shape, initiation of joint movement, and extension of joint movement (e.g., the path the distal tip of the scope travels from the starting position to the end or maximum joint movement position) at the distal end of the highly flexible or bendable portion. The main trunk of the tube may be divided into several regions, segments, or areas, each region containing several notches to make that region highly flexible. Notches may be achieved, for example, by laser cutting a “pattern” within the region of the tube. The cut tubes may then be electropolished or otherwise smoothed to help remove any sharp edges and / or jagged edges on the cut edges.

[0006] In drawings that are not necessarily drawn to scale, similar numbers may describe similar components from different perspectives. Similar numbers with different suffixes may represent different instances of similar components. The drawings as a whole illustrate the various embodiments discussed in this document, not as limitations but as examples. [Brief explanation of the drawing]

[0007] [Figure 1] This figure shows an example of a main tube with multiple regions containing alternating fine and coarse cuts. [Figure 2A] An alternative diagram of the tube in Figure 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]An alternative diagram of the tube in Figure 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] An alternative diagram of the tube in Figure 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] An alternative diagram of the tube in Figure 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] The figure shows examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, in order to achieve joint movement at different angles. [Figure 3B] The figure shows examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, in order to achieve joint movement at different angles. [Figure 4A] The figure shows examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, in order to achieve joint movement at different angles. [Figure 4B] The figure shows examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, in order to achieve joint movement at different angles. [Figure 5A] The figure shows examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, in order to achieve joint movement at different angles. [Figure 5B] The figure shows examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, in order to achieve joint movement at different angles. [Figure 6] This figure shows an example of a tube with opposing open or closed notches during vigorous joint movement. [Figure 7A] This figure shows examples of fine and coarse articular joint movements. [Figure 7B] This figure shows examples of fine and coarse articular joint movements. [Figure 8] This figure shows an example of a tube with highly flexible regions constructed with feature sections that are arranged at rotational angles relative to each other. [Figure 9] This figure shows examples of fine and coarse cut lines incorporated into the endoscope shaft joint motion performance in simulated use. [Modes for carrying out the invention]

[0008] This document describes, among many, medical devices for arthromasticity. For example, disclosed herein is a system for alternating fine and coarse notches of a hybrid tube for arthromasticity areas, for attachment to medical scopes such as endoscopes. The system comprises a tube formed from a solid material (e.g., surgical stainless steel or similar), which has an inner diameter and an outer diameter. At least one deflectable or other highly flexible segment or other area may be formed within the tube. Each segment may comprise a plurality of first slits, notches, or other openings (e.g., coarse notches) having a first thickness or width, and a plurality of second slits, notches, or other openings (e.g., fine notches) having a second thickness or width. In the example, certain coarse notches may be located opposite certain fine notches (e.g., across the tube from certain fine notches) and adjacent to different certain fine notches. Coarse notches may have a greater width than the opposing fine notches. For example, a coarse cut may have a width of 0.015 or 0.016 inches, and a fine cut may have a width of 0.003 inches. The width of either a coarse or fine cut may be specified by any thickness desired for the tube or portion of the tube to achieve a particular "flexion" angle of joint movement and the separation distance between adjacent cuts.

[0009] Similarly, a tube may have as many highly flexible segments as desired for the specific use, procedure, application, or similar in which the tube will be implemented. Likewise, each segment may have as many coarse and fine notches as desired to achieve a direction of joint movement (e.g., two-way joint movement, four-way joint movement, etc.) and joint movement at specific angles (e.g., 90 degrees, 260 degrees, 300 degrees, etc.). The coarse and corresponding fine notches may be formed within 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 main tube) is formed between each coarse and their corresponding fine notches, etc. The switchback member can open or close opposing notches during joint movement of the main tube.

[0010] In the example, the notch may be pulled and closed using an articulated member such as a cable or wire or a “pull wire”. In the example, one or more pull wires may be mounted or guided (e.g., slidably) inside a portion of the tube (e.g., a wider portion, the outer edge of the inner diameter, or any other desired or preferred inside portion of the tube). The pull wire mounting portion may be located inside the tube. Such a pull wire mounting portion may allow the associated pull wire to pass through it from the proximal end to the distal end of the tube. This preferably allows the position of the pull wire to be maintained along a highly flexible area so as to allow deflection or bending of the distal end when the pull wire is retracted by a handle or other pull wire manipulator. Depending at least in part to how many times the device will be deflected or bent, there may be as many pull wires as desired for a particular device. For example, there may be two pull wires on opposing sides for a bidirectional deflectable device, and four pull wires for a quad-directional deflectable device, and so on.

[0011] In the example, during articulation of the main line, the coarse cuts may be pulled and closed when the main line is bent. For example, during articulation, the coarse cuts may be "pulled and closed" from their neutral thickness or width (e.g., 0.015 inches) to a width or thickness of 0.0077 inches. Bending moments may be transmitted through transmission members located within the main line (e.g., a central "beam"). For example, bending moments may be transmitted to switchback members between adjacent coarse cuts, between adjacent fine cuts, or between both. This can cause the fine cuts to open when the coarse cuts are pulled and closed. Conversely, when the fine cuts are pulled and closed, the switchback members can cause the opposing coarse cuts 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 notches can be stretched and opened wider (e.g., from a neutral width of 0.003 inches to a width of 0.0072 inches) or narrowed (e.g., from a neutral width of 0.003 inches to a width of 0.0020 inches) depending on how the main tube is articulated. The starting or neutral width of the coarse or fine notches can vary at different points in the tube. Similarly, the width of the notches that can be biased and opened or closed during the articulation of the main tube can vary. The stiffness of the central beam or other transmission members can also vary in certain adjacent sections of the main tube to allow for selection of the spreading path, the intermediate and final positions of the endoscope tip, or similar adjustments.

[0012] Forming a switchback member between a coarse cut and a fine cut can help provide increased articulation capability of the highly flexible portion of the tube, allowing the main line to have a smaller radius curve for a given main line length (compared to an uncut stainless steel main line design) without causing plastic deformation. This smaller radius curve may be desirable for endoscopes in some applications or procedures as it helps improve access by the distal portion of the scope to specific parts of anatomical structures (e.g., the cups below the kidneys).

[0013] A patterned tube for enabling joint movement (flexion) may include at least one highly flexible region along at least a portion of the length of the tube, the length of which extends from the proximal end to the distal end of the tube. The highly flexible region may include a plurality of first notches having a first notch thickness and a plurality of second notches having a second notch thickness. Specific second notches may be located substantially opposite each other across the tube laterally from specific first notches. Specific second notches may be aligned with specific first notches, or alternatively, offset from specific first notches. Specific first and second notches may be separated by a switchback member.

[0014] The tube may further include one or more bending moment transmission members located between specific adjacent first notches and specific adjacent second notches, connecting adjacent switchback members. Each of the one or more bending moment transmission members may include a circumferential portion extending around the outer circumference of the tube, configured to transmit a bending moment to a switchback member formed within the tube between specific first notches and specific second notches. The switchback member may be configured to cause one of the specific first notches to widen or narrow, and the opposing specific second notch to widen or narrow, during articulation of the portion of the tube containing the specific first notches and the opposing specific second notches. In other words, when the tube is bent or articulated, the switchback member located between the first and second notches may cause one of these notches to open and the opposing notch to close, or vice versa.

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

[0016] The tube may include a plurality of highly flexible regions such as a first highly flexible region and a second highly flexible region. For example, the second highly flexible region may be positioned adjacent to the first highly flexible region. In an example, at least a portion of the second highly flexible region may be constructed with a feature (such as a switchback member, notch, or the like), and this feature is arranged at a rotational angle with respect to a similar feature within the first highly flexible region. In an example, 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 highly flexible region and the second highly flexible region have different flexibilities.

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

[0018] Thinner walls at or towards the distal end can provide additional flexibility to the tube, in addition to what the notch pattern can offer. Such variations in thickness can be achieved in integrally molded tubes, or similar variations in flexibility can be achieved by forming the tube with two or more segments (e.g., within adjacent areas) of different material compositions with different flexibility and / or welded or otherwise joined together.

[0019] Figure 1 is a diagram illustrating an example of a main tube with multiple regions, where specific regions include alternating fine and coarse cuts. Figure 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 each other along the length of the patterned tube 100. For example, the first highly flexible segment 106 may be adjacent to the second highly flexible segment 108, and the second highly flexible segment 108 may be adjacent to the third highly flexible segment 110.

[0020] The highly flexible areas 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. Certain fine cuts among the plurality of fine cuts 128-138 may be aligned substantially opposite each other across the patterned tube 100, laterally spanning across certain coarse cuts among the plurality of coarse cuts 118-126. For example, coarse cut 118 and fine cut 128 may be located substantially opposite each other across the lateral span. Similarly, coarse cut 120 may be located substantially opposite each other across the lateral span of fine cut 130, and so on. Alternatively, certain fine cuts among a plurality of fine cuts 128-138 may be offset from certain coarse cuts among a plurality of coarse cuts 118-126 and positioned across the patterned tube 100. In the example, the patterns of coarse 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, certain fine cuts exist between two certain coarse cuts. The cut cylinder of the patterned tube may be referred to as its cylindrical trunk. For example, as illustrated in Figure 1, on one side of the tube, cut 118, which is a certain coarse cut among a plurality of coarse cuts having a first cut thickness, is adjacent to cut 140 having a second cut thickness. Cut 140 having a second cut thickness is again adjacent to cut 120 having a first cut thickness. Similarly, on the opposite side of the cylinder, the cut 142 having a first cut thickness lies 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] Figures 2A–2E are alternative diagrams of the tube in Figure 1, including a conceptual diagram of the tube where the cylinder is conceptually cut longitudinally, “unfolded,” flattened, and enlarged, in order to provide a more detailed view of the cuts and the switchback members formed between the cuts. Figure 2A again shows the patterned tube 100 of Figure 1, and Figure 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, detail A 201A marked with a circle within the second highly flexible segment 108, a fifth highly flexible segment 114, and detail B 202A marked with a circle within the fifth highly flexible segment 114. Detail A 201A and detail B 202A are enlarged to a 16:1 scale in Figures 2C and 2D, respectively. As illustrated in Figure 2C, i.e., the highlighted view of detail A 201A, an example width for a coarse cut 206 may be 0.15 inches, and an example width for a corresponding fine cut 208 may be 0.003 inches. A switchback member may be formed between opposing first and second cuts. For example, a first switchback member 210 may be formed between a coarse cut 206 and a fine cut 208. Similarly, a second switchback member 214 may be formed adjacent to the first switchback member 210.

[0022] When deployed, the switchback member may be formed in a U-shape (e.g., horseshoe-shaped), but the switchback member may be of a different or other shape. For example, when deployed, a particular switchback member may be triangular (e.g., "V"-shaped), rectangular, octagonal, or any other suitable shape to achieve a desired bending force or degree of deflection of each notch in which the switchback member is formed. In the example, the shape of the switchback member in one part of the patterned tube 100 may differ from that in another part of the patterned tube 100. For example, in the first highly flexible segment 106, the switchback member may be U-shaped (when deployed), while in the second highly flexible segment 108, the switchback member may be triangular (when deployed), and in the third highly flexible segment 110, the switchback member 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.) can be selected or vary to help satisfy the desired degree of deflection of the fine and coarse cuts.

[0023] The notch patterns described above may result in adjacent switchback members being offset and oriented opposite to each other. For example, the U-shaped "bend" of the first switchback member 210 when unfolded may be oriented in the opposite direction (e.g., face, point, etc.) to that of the second switchback member 214, so that when the patterned tube 100 is "unfolded" and flattened as illustrated in Figure 2B, the first switchback member 210 may appear concave upwards, and the second switchback member 214 may appear concave downwards. In another example, the distance or length of the notch into the switchback segment may be determined or specified to control the flexibility at that point. For example, the "end" of the fine notch 216 in Figure 2D may be a "y" unit to the "end" of the portion of the switchback member 220 that is concave downwards. Therefore, in order 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 recessed portion below the switchback member 220 (resulting in a longer "length" of the notch 216). The longer the notch 216 extends 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 transmission member 212 may be positioned between adjacent coarse cuts and adjacent fine cuts to connect adjacent switchback members, such as the first switchback member 210 and the second switchback member 214. The bending moment transmission member 212 may include, for example, a circumferential portion extending around the outer circumference of the patterned tube 100 and may be configured to transmit bending moments to the switchback members, for example, the first switchback member 210 and / or the second switchback member 214.

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

[0026] In the example, as illustrated in Figure 2D illustrating the enlarged portion 200D of the unfolded tube 200, the width of the coarse notches can vary along the length of the tube. For example, coarse notches may be wider or thicker when encountered in the direction from the proximal end to the distal end. As illustrated in the enlarged portion 200D, coarse notch 232 is wider than coarse notch 230, coarse notch 230 is wider than coarse notch 228, and so on. It should also be understood that opposing fine notches can be made wider in a similar procedure or manner to coarse notches, or that fine notches can maintain the same width along the length of the highly flexible segment and / or the length of the tube. Thus, in such examples, the further distal the portion of the highly flexible area is, the larger the width of the “gap” or opening of the coarse notches, and therefore more joint movement can be achieved. In other words, the distal portion of the highly flexible zone can be deflected by a greater or greater angle than the proximal end of the highly flexible zone. This can allow the distal portion to bend more sharply, enabling the scope to contact more difficult-to-reach areas of anatomical structures, such as the cups below the kidney.

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

[0028] In the example, at least one 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 enlarged portion 200D, the coarse cuts 224, 226, 228, 230, and 232 may include tapered portions, such as the tapered portion 234 in cut 224, or the tapered portion 236 in cut 226. The amount of tapering may depend on the width of the cut in which the tapering is included.

[0029] Figures 3A–5B illustrate examples of tubes with various numbers of highly flexible sections, including different numbers of notches, different notch widths, and different numbers of wire guides, to achieve joint movement at different angles. Figures 3A, 4A, and 5A show top views of each tube, while Figures 3B, 4B, and 5B show side views of each tube. Figures 3A–5B illustrate different representative embodiments of the tubes with different lengths and numbers of highly flexible sections, different spacing between highly flexible sections, and different arrangements and numbers of wire guide positions. Figure 3A illustrates an example of 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 notches (as described above) and extends to 0.392 inches. In the first highly flexible region 302, the width of the fine cuts can vary from 0.003 inches to 0.025 inches. The distance between the cuts (and therefore the width of the "beam" between the cuts) can be 0.011 inches.

[0030] The second highly flexible area 304A may have a length of 0.382 inches and may include 17 notches. Furthermore, the size of the switchback member (e.g., the width of tube 300A when viewed from above) may be 0.0344 inches. The second highly flexible area 304A may include a total of 17 notches and extend to a length of 0.384 inches. The third highly flexible area 306A may include a total of 18 notches and extend to a length of 0.408 inches. In the third highly flexible area 306A, the distance between the fine notches (and therefore the width of the central beam between the notches) may range from 0.009 inches to 0.021 inches. The fourth highly flexible area 308A may include 18 notches and extend to 0.408 inches of tube 300A. The fifth highly flexible section 310A of tube 300A includes 14 notches and may extend to 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] As illustrated in Figures 3A and 3B, joint movement member wire guide positions 312A to 322A and 312B to 322B may exist adjacent to the highly flexible regions 302A to 310A and 302B to 310B. Wire guide positions 312 to 322 may be "thicker" portions of tubes 300A and 300B that separate the highly flexible regions 302 to 310 (e.g., portions of tubes 300A and 300B with fewer notches or without notches), allowing joint movement members such as pull wires to be positioned inside tubes 300A and 300B. The wire guide positions 312A–322A and 312B–322B allow the articulating members to be held in place along the inner diameter of tubes 300A and 300B, so that when the articulating members are pulled, the highly flexible zones 312A–322A and 302B–310B can bend or deflect the distal ends of tubes 300A and 300B in the direction in which the articulating members are being pulled. As illustrated in Figure 3B, the wire guide position 322B, located toward the distal end of tube 300B, may be located at a certain distance from the tip of tube 300B, such as 0.140 inches from the end of tube 300B. The dimensions illustrated in Figures 3A and 3B can allow for an articulation angle of 263 degrees (for example, at the distal ends of tubes 300A and 300B). In such an example, flexion or joint movement may be initiated in the three middle sections, namely the second highly flexible section 304A, the third highly flexible section 306A, and the fifth highly flexible section 308A, which consist of a total of 53 notches and extend 1.344 inches of the tube 300A.

[0032] As illustrated in Figures 4A and 4B, the length of tubes 400A and 400B (3.00 inches) may be longer than the example illustrated in Figures 3A and 3B. Furthermore, tubes 400A and 400B may include six highly flexible sections 402A-412A and 402B-412B. The first highly flexible section 402A and the second highly flexible section 404A each may include 16 notches and be 0.360 inches long. The third highly flexible section 406A may also include 16 notches but be 0.384 inches long. The fourth highly flexible section 408A, the fifth highly flexible section 410A, and the sixth highly flexible section 412A all may include 14 notches and be 0.364 inches long. Such a configuration can essentially "divide" or separate the tube 300A into two main parts: a first highly flexible region 402A, a second highly flexible region 404A, and a third highly flexible region 406A, which includes 49 notches and extends 1.248 inches; and a second highly flexible region 408A, a fifth highly flexible region 410A, and a sixth highly flexible region 412A, which includes 42 notches and extends 1.260 inches. As shown in Figure 4A, the notch widths can vary from 0.021 inches between the fine notches in the second highly flexible region 404A, and 0.025 inches between the fine notches in the fifth highly flexible region 410A, and so on. Similarly, the beam width between the cuts may vary, such as 0.009 inches in the second highly flexible area 404A and 0.011 inches in the fifth highly flexible area 410A.

[0033] Furthermore, as illustrated in Figure 4A, the size of the switchback member (as discussed above with respect to Figure 3A) may vary along the length of tube 400A (for example, within different highly flexible zones). For example, in the first highly flexible zone 402A, the size of the switchback member may be 0.0315 inches. In the second highly flexible zone 404A, the size of the switchback member may be 0.0344 inches, in the third highly flexible zone 406A it may be 0.072 inches, in the fourth highly flexible zone 408A it may be 0.0315 inches, in the fifth highly flexible zone 410A it may be 0.0344 inches, and in the sixth highly flexible zone 412A it may be 0.0372 inches. The width of the cuts in each section may be uniform or vary as discussed above. Tubes 400A and 400B may include seven wire guide positions 414A–426A and 414B–426B, with the most distal wire guide positions 426A and 426B located 0.138 inches from the tip of tubes 400A and 400B. The dimensions illustrated in Figures 4A and 4B may allow for a joint motion angle of 292 degrees (for example, at the distal end of tubes 400A and 400B).

[0034] Figures 5A and 5B illustrate typical main lines of tubes 500A and 500B, extending 3.118 inches. Tubes 500A and 500B have main lines that are highly flexible along the entire length in which the switchback members are formed, instead of having deflectable or highly flexible sections, as illustrated in Figures 3 and 4. Different sections of tubes 500A and 500B can be fabricated to have different amounts of flexibility by varying the size of the switchback members, the cut width (and therefore the central beam width) in the different sections of 500A and 500B. As illustrated in Figure 5A, tube 500A may have cuts in a pattern such that adjacent switchback members extend 2.772 inches of the length of tube 500A. In the example, the first portion 506 of tube 500A may include 10 notches and extend to 531 inches, and the second portion 508 of tube 500A may include 11 notches and extend to 0.678 inches. In the second portion 508, the edge of the switchback member may be 0.047 inches, the width of the central 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] Further distally, tube 500A may include a third section 510 with eight notches and extending 0.536 inches, and a fourth section 512 with eight notches and extending 0.536 inches. In the fourth section 512, the edge of the switchback member 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, the width of the central beam, and the notch widths may be uniform or varied as needed to achieve the desired degree of deflection of tubes 500A and 500B.

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

[0037] As illustrated in the examples in Figures 3A to 5B, the tube may have any number of highly flexible sections or areas, switchback members of any size, any cut width, or any number of wire guide positions, as desired or as needed. For example, the tube may include five, six, or seven wire guide positions, have cut widths of 0.003 inches, 0.0025 inches, and 0.0032 inches, and have cut areas with different amounts of cuts and different beam widths in 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 distal 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 the example, the tube may have a proximal section with 14 or 15 notches and a beam width of 0.011 inches, and a distal section with 17 or 18 notches and a beam width of 0.009 inches. In the example, the tube may have a proximal section with 14 notches and a beam width of 0.011 inches, and a distal section with 16 or 17 notches and a beam width of 0.009 inches. In the example, another tube may have a proximal section 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 section with 12 notches and a beam width of 0.011 inches. In the example, the tube may have a proximal section with 14 notches and a beam width of 0.011 inches, and a distal section with 16 notches and a beam width of 0.009 inches. The tube may be formed with multiple proximal, central, and distal sections 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] Figure 6 shows an example of a tube with open and opposing closed notches during active articulation. Figure 6 illustrates an example of a tube 600 with alternating coarse and fine notch patterns, such as those discussed above. As illustrated in Figure 6, an articulating member 602, such as a wire or cable, may be positioned along the inner portion of the tube 600 such that when the articulating member 602 is pulled or otherwise engaged, the coarse notch 604 is pulled or articulated to a width of 0.0077 inches, narrower than the neutral notch thickness, and the fine notch 608 adjacent to the coarse notch 604 is 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 notch 606 opposite the coarse notch 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 articulate to a wider thickness (e.g., 0.0191 inches) compared to its neutral or starting thickness in the absence of flexion.

[0040] Pulling or manipulating the joint movement member 602 can cause different parts of the tube 600 to bend at different angles, as illustrated in Figure 6. For example, smaller parts of the tube 600 may bend at smaller angles (e.g., 3.93 degrees, 3.83 degrees, etc.), while larger parts of the tube 600 may bend at larger angles, such as 9.37 degrees.

[0041] Generally, the wider the neutral cut width of the coarse cut, the more material is moved when the tube is deflected or bent. This results in a “steeper” bend, allowing the fine cuts to expand (spread) to provide some “flexibility,” and allowing the coarse cuts to contract toward each other during the bending motion. The tubes described herein may be designed to reach target portions of anatomical structures such as the cups of the kidney, including the inferior cups, and such abrupt and forceful rotation of the tube may be required for the scope to reach such anatomical structures. Thus, as discussed above, different tubes may be designed with different dimensions, such as different cut widths, different numbers of cuts, or similar, so that the joint movement or highly flexible area can be bent at angles greater than 180 degrees (e.g., 250 degrees, 270 degrees, 300 degrees, or more).

[0042] Figures 7A and 7B illustrate examples of fine / coarse notch trunk articular motion. As illustrated in Figures 7A and 7B, articular motion trunks 700 (e.g., deflectable trunks, articular motion tubes, etc.) with alternating coarse / fine notch patterns, such as those described above, can be mounted on non-articular motion solids or more rigid members 702, such as scopes, handles, or similar. The articular motion trunks 700 can be bent in such a manner that the tip 704 of the articular motion trunks 700 can be bent from a straight position (180-degree angle) to an angle greater than 270 degrees, as illustrated in Figure 7A, or to an angle greater than 300 degrees, as illustrated in Figure 7B.

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

[0044] Such patterns can be repeated 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 each other or offset from each other.

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

[0046] Figure 9 illustrates examples of fine / coarse notched trunk lines incorporated into the joint motion performance of the endoscope shaft in simulated use. As illustrated in Figure 9, an endoscope 900 with trunk lines employing an alternating notch pattern, such as those described herein, is illustrated for use in a model portion of an anatomical structure 902. The model portion of the anatomical structure 902 may represent a part of a human anatomical structure, such as a kidney cup, into which the endoscope 900 may be inserted during medical procedures such as kidney stone ablation. In the example in Figure 9, the model portion of the anatomical structure 902 includes a cavity 904 in which a stone, tumor, or similar may form. The tip of the endoscope 900 can be manipulated or bent around a piece of tissue represented by a rectangular area of ​​the model portion of the anatomical structure 902, so that procedures such as stone ablation can be performed in the cavity 904 by emitting laser radiation from the tip of the endoscope 900.

[0047] Additional Descriptions and Examples Embodiment 1 is a patterned tube that enables articulation of a medical scope, the patterned tube comprising at least one highly flexible region between the proximal end and the distal end of the patterned tube, the at least one highly flexible region comprising 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 each other across the patterned tube laterally 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 located between adjacent certain of the first notches and further between adjacent certain of the second notches, connecting adjacent switchback members.

[0048] In Example 2, the subject of Example 1 optionally includes the fact that one or more bending moment transmission members each include a circumferential portion extending around the outer circumference of a patterned tube and are configured to transmit a bending moment to a switchback member formed within the patterned tube between a specific first cut and a specific second cut.

[0049] In Embodiment 3, the subject of Embodiment 2 optionally includes the configuration such that the switchback member causes a particular first notch to either widen or narrow, and an opposing particular second notch to either widen or narrow, during articulation of a portion of a patterned tube including the particular first notch and the opposing particular second notch.

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

[0051] In Example 5, the subject of Example 4 optionally includes the fact that the articulating member is mounted on the inner portion of the patterned tube by at least one guide configured to maintain the position of the articulating member along a highly flexible area and to allow deflection of at least a portion of the highly flexible area when the articulating member is retracted by the manipulator.

[0052] In Example 6, any one or more themes from Examples 4 to 5 optionally include the fact that the joint movement member includes a cable or wire.

[0053] In Example 7, any one or more themes from Examples 1 to 6 optionally include the fact that the neutral thickness of a plurality of first cuts and the neutral thickness of a plurality of second cuts vary along at least a portion of at least one highly flexible region.

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

[0055] In Example 9, one or more of the themes from Examples 7 to 8 optionally include the condition that, in the neutral state, a specific second notch at the distal end of the highly flexible region is wider than a specific second notch at the proximal end of the highly flexible region.

[0056] In Example 10, one or more subjects from Examples 1 to 9 optionally include a first highly flexible region and a second highly flexible region located adjacent to the first highly flexible region.

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

[0058] In Example 12, one or more of the themes from Examples 10 to 11 optionally include the fact that 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 the fact that the material in the first highly flexible region and the material in the second highly flexible region have different flexibility.

[0060] In Example 14, one or more of the themes from Examples 1 to 13 optionally include the condition that the outer diameter of the patterned tube at the distal end of the patterned tube is smaller than the outer diameter at the proximal end of the patterned tube.

[0061] In Example 15, one or more of the subjects from Examples 1 to 14 optionally include that at least one of at least a portion of a particular first notch or at least one of at least one of a particular second notch is tapered to accommodate a particular switchback member located within at least a portion thereof.

[0062] Embodiment 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 comprising 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 each other across the tube laterally from certain of the first notches and separated from certain of the first notches by a switchback member, and one or more bending moment transmission members, certain of the one or more bending moment transmission members located between certain adjacent of the first notches and further between certain adjacent of the second notches, connecting adjacent switchback members.

[0063] In Example 17, the subject of Example 16 optionally includes the fact that the neutral thickness of a plurality of first cuts and the neutral thickness of a plurality of second cuts vary along at least a portion of at least one of the first highly flexible region or the second highly flexible region.

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

[0065] In Example 19, one or more of the themes from Examples 17 to 18 optionally include, in the neutral state, at least one of the following: a specific first notch at the distal end of the second highly flexible region is wider than a specific first notch at the proximal end of the second highly flexible region, or a specific second notch at the distal end of the second highly flexible region is wider than a specific second notch at the 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 articulating member mounted on the inner portion of the deflectable portion by at least one guide configured to maintain the position of the articulating member along the highly flexible region and to allow deflection of at least a portion of the highly flexible region when the articulating member is retracted by an operating tool, wherein the first and second highly flexible regions are first notches The device comprises a plurality of first notches having thickness, a plurality of second notches having second notch thickness, where certain of the second notches are located substantially opposite to certain of the first notches, spanning laterally across the deflectable portion and separated therefrom by a switchback member, and one or more bending moment transmission members, where certain of the one or more bending moment transmission members are located between adjacent certain of the first notches and, further, between adjacent certain of the second notches, connecting adjacent switchback members.

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

[0068] In Example 22, one or more of the subjects from Examples 20 to 21 optionally include the fact that at least a portion of the second highly flexible region is constructed with at least one notch positioned at a rotational angle with respect 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 referenced herein are incorporated by reference in their entirety, as if each were individually cited. In the event of any conflicting use between this document and those cited documents, the use in the cited reference should be considered supplementary to this document, and in the case of an incompatible conflict, the use in this document shall prevail.

[0070] In this text, the terms “a” or “an” are used to include one or more, as is common in patent documents, independently of any other use of “at least one” or “one or more.” In this text, the term “or” is used to mean non-exclusively, or, unless otherwise stated, “A or B” is used to include “A but not B,” “B but not A,” and “A and B.” In the attached claims, the terms “including” and “in which” are used as plain English equivalents of the terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, meaning that a system, device, article, or process that includes elements in addition to those listed before such terms in the claim is still considered to fall within the scope of that claim. Furthermore, in the following claims, terms such as "First," "Second," and "Third" are used merely as labels and are not intended to impose numerical requirements on their subjects.

[0071] The above description is intended to be illustrative and not restrictive. For example, the examples (or one or more embodiments thereof) described above may be used in combination with each other. Other embodiments may be used, for example, by those skilled in the art when reconsidering the above description. The abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims, and that it will allow the reader to quickly grasp the essence of the technical disclosure. Furthermore, in the forms for carrying out the above invention, various features may be combined together to simplify the disclosure. This should not be interpreted as an intention that any disclosed feature not claimed is essential to any claim. Rather, the subject matter of the invention may not satisfy all the features of a particular disclosed embodiment. Thus, the following claims are incorporated into the forms for carrying out the invention, with each claim standing alone as a separate embodiment. The scope of the embodiments should be determined by reference to the appended claims, together with the entire scope of equivalents to which such claims are received.

Claims

1. A patterned tube that enables joint movement of a medical scope, wherein the patterned tube is The patterned tube is provided with at least one highly flexible region between its proximal and distal ends, and the at least one highly flexible region is A first notch having branched ends that form two ends, A second notch having an end located between the two ends of the branch end of the first notch, Patterned tubes, including...

2. A patterned tube according to Claim 1, wherein the first cut has a first cut width and the second cut has a second cut width different from the first cut width.

3. A patterned tube according to claim 1 or claim 2, wherein the width of the first cut is greater than the width of the second cut.

4. A patterned tube according to any one of claims 1 to 3, wherein the first notch and the second notch are located substantially opposite each other across the patterned tube in a transverse direction.

5. A patterned tube according to any one of claims 1 to 4, further comprising an articulating member attached to the inner portion of the patterned tube.

6. A patterned tube according to claim 5, wherein the articulated member is attached to the inner portion of the patterned tube by at least one guide, and the at least one guide is configured to maintain the position of the articulated member along the at least one highly flexible region.

7. A patterned tube according to claim 5 or claim 6, wherein the articulating member includes at least one of a cable or a wire.

8. A patterned tube according to any one of claims 1 to 7, wherein the outer diameter at the distal end of the patterned tube is smaller than the outer diameter at the proximal end.

9. A patterned tube according to any one of claims 1 to 8, wherein the at least one highly flexible region includes a first highly flexible region and a second highly flexible region located adjacent to the first highly flexible region.

10. A patterned tube according to claim 9, wherein the first highly flexible region is formed from a material different from the second highly flexible region.

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