Articulating medical instrument

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 hereby incorporated 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 of a human or animal, or inside the abdomen. Portions of the scope, such as the distal end of the scope, can be made highly flexible to allow a surgeon to 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 can be used in various surgical procedures, such as otolaryngology (ENT) procedures like 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. In many cases, during a surgical procedure, it may be desirable for at least a portion of the scope to be articulately moved so that it can be angled (e.g., bent) from a straight zero degree to an angle such as 15 degrees, 30 degrees, 45 degrees, 90 degrees, 200 degrees, or more. The sheath or tube of the scope or catheter (e.g., a hypotube or subcutaneous tube, or other cylindrical or non-cylindrical tubes having a specific inner diameter and outer diameter or similar lateral dimensions) can be made of or formed from a high-rigidity material such as surgical-grade stainless steel, an alloy, or another similar material that is made highly flexible and can bend or flex at an angle. Such flexibility can be achieved by forming a series of cuts (e.g., laser cuts) within the tube. Different types of cuts within the tube (e.g., finer or thinner cuts, coarser or wider cuts, or the like) can be utilized, and each type of cut has its specific characteristics. For example, different types of cuts (e.g., different cut widths) can affect the degree to which the highly flexible portion of the tube can be bent, the amount of torque that the tube can maintain, the compression effect under load, or the like.

[0005] One way to solve these problems is to use a combination of rough cuts and fine cuts in a patterned tube deflectable region of a medical device that can be connected to a scope tube or a portion of a sheath, i.e., the scope to be made highly flexible. In an example, the rough cuts and fine cuts can be alternated so as to help achieve large angle articulation movement and reduce or minimize the compression effect during cut loading by staying within the high elastic material property region of the material. The depth, width, length, and number of the cuts can vary to achieve the desired degree of articulation movement, joint shape, start of articulation movement, articulation movement spread (e.g., the path that the distal tip of the scope travels from the starting position to the end or maximum articulation position), etc. at the most distal end of the highly flexible or bendable portion. The main trunk of the tube can be divided into several regions, segments, or zones, each region containing 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 can then be electropolished or otherwise smoothed to help remove any sharp edges and / or serrations on the edges of the cuts.

[0006] In drawings that are not necessarily drawn to scale, like numbers can describe like components from different viewpoints. Like numbers with different suffixes can represent different instances of like components. The drawings, generally, illustrate various embodiments discussed in this document by way of example and not limitation.

Brief Description of the Drawings

[0007]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 6

Figure 7A

Figure 7B

Figure 8

Figure 9

Mode for Carrying Out the Invention

[0008] This document describes, among other things, arthrokinematic medical devices. For example, disclosed herein is a system for attachment to a medical scope, such as an endoscope, for a hybrid of tubes with alternating fine and coarse cuts for an arthrokinematic region. 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 other region 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 on the opposite side of the tube from 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 greater width 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 cuts or the fine cuts may be specified by any desired thickness for the tube or a portion of the tube and the separation distance between adjacent cuts to achieve a particular "flexure" angle of arthrokinematics.

[0009] Similarly, the tube can have as many highly flexible segments as desired for a particular use, procedure, application, or the like in which the tube is to be implemented. Similarly, each segment can have as many rough cuts and fine cuts as desired to achieve a direction of articulation movement (e.g., two-direction articulation movement, four-direction articulation movement, etc.) and a specific angle of articulation movement (e.g., 90 degrees, 260 degrees, 300 degrees, etc.). The rough cuts and corresponding fine cuts can 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 trunk of the tube) is formed between each rough cut and their corresponding fine cuts. The switchback member can open or close opposing cuts during the articulation movement of the trunk of the tube.

[0010] In an example, the cuts can be pulled closed using an articulation movement member such as a cable or wire or "pull wire". In an example, one or more pull wires can 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 inner portion of the tube as desired or suitable). The pull wire attachment can be located on the inner portion of the tube. Such a pull wire attachment can allow the associated pull wire to pass therethrough from the proximal end to the distal end of the tube. This can preferably maintain the position of the pull wire along a highly flexible region so as to allow deflection or bending of the distal end when the pull wire is retracted by a handle or other pull wire operating tool. Depending at least in part on how many times the device is to be deflected or bent, there can be as many pull wires as desired for a particular device. For example, there can be two pull wires on opposing sides for a two-direction deflectable device, four pull wires for a four-direction deflectable device, etc.

[0011] In an example, during articulation of the main body, the wide cuts can be pulled closed as the main body is bent. For example, during articulation, the wide cuts can 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 can be transmitted through a transmission member (e.g., a central “beam”) located within the main body. For example, the bending moment can be transmitted to a switchback member between adjacent wide cuts, between adjacent fine cuts, or between both. Thereby, when the wide cuts are pulled closed, the fine cuts can be opened. Conversely, when the fine cuts are pulled closed, the switchback member can open opposing wide cuts (e.g., from a neutral thickness or width of 0.015 inches to a width or thickness of 0.019 inches). The fine cuts can be pulled open wider (e.g., from a neutral width of 0.003 inches to a width of 0.0072 inches) or made narrower (e.g., from a neutral width of 0.003 inches to a width of 0.0020 inches), depending on how the main body of the tube is articulated. The starting or neutral width of the wide cuts or fine cuts can vary at different locations of the tube. Similarly, during articulation of the main body, the width of the cuts that can be biased open or closed can vary. The rigidity of the central beam or other transmission members can also vary in certain adjacent regions of the main body to allow selection of an expansion path, intermediate and final positions of the endoscope tip, or the like.

[0012] Forming a switchback member between the wide cuts and the fine cuts can help provide an increased articulation ability for a highly flexible portion of the tube, allowing the main body to have a smaller radius of curvature for a given main body length without causing plastic deformation (relative to an uncut stainless steel main body design). This smaller radius of curvature can be desirable for an endoscope in some applications or procedures to help improve access to a particular site of an anatomical structure (e.g., the lower calyx of the kidney) by the distal portion of the scope.

[0013] The patterned tube that enables joint movement (flexion) may include at least one highly flexible region along at least a portion of the length of the tube, and the length of the tube extends from the proximal end of the tube to the distal end of the tube. The highly flexible region may include a plurality of first cuts having a first cut thickness and a plurality of second cuts having a second cut thickness. Particular ones of the second cuts may be located substantially opposite across the tube from particular ones of the first cuts. Particular second cuts may be aligned with particular first cuts or, alternatively, may be offset from particular first cuts. Particular first cuts 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 particular ones of the first cuts and adjacent particular 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 outer circumference of the tube configured to transmit a bending moment into a switchback member formed within the tube between a particular one of the first cuts and a particular one of the second cuts. The switchback member may be configured to cause one of a particular first cut to widen or narrow and the other of an opposing particular second cut to widen or narrow during joint movement 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 undergoes joint movement, the switchback member located between the first cut and the second cut may cause one of these cuts to open and the opposing cut 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 comprise 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 (e.g., 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 more proximal portions. Such a change in the wall thickness of the tube may be abrupt (e.g., a "step" changing from a thickness of "x" centimeters or inches at a particular point to 0.75x centimeters or inches), or may include a gradually decreasing change 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] A thinner wall at or toward the distal end can provide additional flexibility to the tube in addition to what the cut pattern can provide. Such a change in thickness can be achieved in a one-piece tube, or a similar change in flexibility can be achieved by forming the tube with two or more segments (e.g., within adjacent regions) of different flexibility and / or different material compositions that are welded or otherwise joined together.

[0019] Figure 1 is a diagram showing an example of a trunk of a tube with multiple regions, where a particular region includes alternating fine cuts 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 can 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 can be positioned substantially adjacent to each other along the length of the patterned tube 100. For example, the first highly flexible segment 106 can be adjacent to the second highly flexible segment 108, the second highly flexible segment 108 can be adjacent to the third highly flexible segment 110, and so on.

[0020] The highly flexible regions 106 - 116 can include a plurality of (first) rough 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 one of the plurality of fine cuts 128 - 138 can be positioned substantially opposite across the patterned tube 100 from a particular one of the plurality of rough cuts 118 - 126. For example, the rough cut 118 and the fine cut 128 can be positioned substantially opposite across from each other. Similarly, the rough cut 120 can be positioned substantially opposite across from the fine cut 130, and so on. Alternatively, a particular one of the plurality of fine cuts 128 - 138 can be offset from a particular one of the plurality of rough cuts 118 - 126 and positioned across the patterned tube 100. In an example, the pattern of rough and fine cuts can be formed on opposite sides of the cylinder forming the patterned tube 100 such that there is a particular fine cut between two particular rough cuts on one side of the cylinder. The cut cylinder of the patterned tube can be referred to as its cylinder trunk. For example, as illustrated in FIG. 1, on one side of the tube, the cut 118, which is a particular one of the plurality of rough cuts having a first cut thickness, is adjacent to the cut 140 having a second cut thickness. The cut 140 having a second cut thickness is again adjacent to the cut 120 having a first cut thickness. Similarly, on the opposite side of the cylinder, the cut 142 having a first cut thickness is between the cuts 128 and 130, each having a second cut thickness. A similar pattern of cuts can be formed in each of the highly flexible segments.

[0021] Figures 2A - 2E are alternative views of the tube of FIG. 1, including conceptual diagrams of a tube that has been vertically cut, "unrolled", flattened, and enlarged to provide a more detailed view of the cutouts and the switchback members formed between the cutouts. 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 "unrolled" and flattened so that it is no longer in a three - dimensional cylindrical shape. The unrolled tube 200 includes a second highly flexible segment 108, a detailed A 201A marked with a circle within the second highly flexible segment 108, a fifth highly flexible segment 114, and a detailed B 202A marked with a circle within the fifth highly flexible segment 114. Detailed A 201A and detailed B 202A are enlarged at a 16:1 scale in FIGS. 2C and 2D respectively. As illustrated in FIG. 2C, i.e., the highlighted view of detailed A 201A, the width of an example of a coarse cutout 206 can be 0.15 inches, and the width of an example of a corresponding fine cutout 208 can be 0.003 inches. A switchback member can be formed between opposing first and second cutouts. For example, a first switchback member 210 can be formed between the coarse cutout 206 and the fine cutout 208. Similarly, a second switchback member 214 can 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 shape), but the switchback member may be of another shape or a different shape. For example, when deployed, a particular switchback member may be triangular (e.g., "V" shape), rectangular, octagonal, or any suitable shape to achieve a desired flexure force or degree of deflection of each notch in which the switchback member is formed. In an example, the shape of the switchback member in one portion of the patterned tube 100 may be different from that in another portion 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 member along the patterned tube 100 (e.g., width, switchback shapes of different radii, etc.) may be selected or may vary to help meet the desired degree of deflection of the fine and coarse notches.

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

[0024] The bending moment transfer member 212 can 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 transfer member 212 can include a circumferential portion, for example, extending around the outer perimeter of the patterned tube 100, and can be configured to transfer the bending moment to the switchback members, for example, to the first switchback member 210 and / or the second switchback member 214.

[0025] In an example, a particular rough cut thickness or width can vary along the length of the patterned tube 100. For example, as illustrated in FIG. 2C, without bending, the rough cut 206 located in the second highly flexible segment 108 of the patterned tube 100 can have a neutral thickness or width of 0.015 inches, and as illustrated in FIG. 2D, the rough cut 218 located in the fifth highly flexible segment 114 can have a neutral thickness or width of 0.016 inches. This can result in the size of the bending moment transmission member between adjacent switchback members, as well as the width of the switchback members, being various in 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 which illustrates the enlarged portion 200D of the deployed tube 200, the rough cut can vary in width along the length of the tube. For example, the rough cut can be wider or thicker when encountered in the direction from the proximal end to the distal end. As illustrated in the enlarged portion 200D, the rough cut 232 is wider than the rough cut 230, the rough cut 230 is wider than the rough cut 228, and so on. It should also be understood that the opposing fine cuts can be made wider in a similar procedure or manner as the rough cuts, or the fine cuts can 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 farther the portion of the highly flexible region is distal, the greater the width of the “gap” or opening of the rough cut, and thus, more articulation movement can be achieved. In different words, the distal portion of the highly flexible region can deflect more or to a greater angle than the proximal end of the highly flexible region. This can enable the distal portion to bend more sharply and allow the scope to contact sites that are more difficult to reach, such as anatomical structures below the kidney calyx.

[0027] In such examples where the width of the notch varies or is varied from the proximal end to the distal end of the highly flexible region, the variation can be gradual (e.g., a linear change in the gap size from a first notch at the proximal end to an “nth” notch at the distal end), or non-linear (e.g., exponential), or more gradual. In another example, the change can be abrupt, such as switching suddenly from a uniform first gap size to a larger second gap size. The gap sizes of the rough notches and / or the fine notches can vary in any pattern, such as one or more of the gap sizes of the notches in the distal portion being wider than one or more of the gap sizes of the notches in the proximal portion.

[0028] In an example, at least one portion of a particular rough notch or a particular fine notch can be tapered to accommodate a particular switchback member. For example, as shown in the enlarged portion 200D, the rough notches 224, 226, 228, 230, and 232 can include tapered portions, such as the tapered portion 234 in the notch 224 or the tapered portion 236 in the notch 226. The amount of tapering can depend on the width of the notch in which the tapering is included.

[0029] Figures 3A - 5B illustrate examples of tubes with various numbers of highly flexible regions that include different numbers of cuts, different cut widths, and different numbers of wire guides to achieve joint movement at different angles. Figures 3A, 4A, and 5A show top views of the respective tubes, while Figures 3B, 4B, and 5B show side views of each tube. Figures 3A - 5B illustrate different exemplary embodiments of the tube with different lengths and numbers of cuts of the highly flexible regions, different spacings between the highly flexible regions, and different arrangements and numbers of wire guide positions. Figure 3A illustrates an example of a tube 300A with a total length of 2.672 inches and five highly flexible regions 302A, 304A, 306A, 308A, and 310A. The first highly flexible region 302 may include a total of 15 coarse and / or fine cuts (as described above) and extend 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 thus the width of the "beam" between the cuts) may be 0.011 inches.

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

[0031] As illustrated in FIGS. 3A and 3B, adjacent to the highly flexible regions 302A - 310A and 302B - 310B, there may be articulation member wire guide positions 312A - 322A and 312B - 322B. The wire guide positions 312 - 322 are the "thicker" portions of the tubes 300A, 300B (e.g., a portion of the tubes 300A, 300B with fewer cuts or no cuts) that allow small holes, loops, rings, or the like to be positioned inside the tubes 300A, 300B such that an articulation member, such as a pull wire, can be positioned inside the tubes 300A, 300B. The wire guide positions 312A - 322A and 312B - 322B can hold the articulation member in place along the inner diameter of the tubes 300A, 300B such that when the articulation member is pulled, the highly flexible regions 312A - 322A and 302B - 310B can bend or deflect the distal ends of the tubes 300A, 300B in the direction in which the articulation member is being pulled. As illustrated in FIG. 3B, the wire guide position 322B, which is located toward the distal end of the tube 300B, can be located at 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 FIGS. 3A and 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, the bending or articulation can consist of a total of 53 cuts and can start in the middle three regions, i.e., the second highly flexible region 304A, the third highly flexible region 306A, and the fifth highly flexible region 308A, which extend 1.344 inches of the tube 300A.

[0032] As illustrated in FIGS. 4A and 4B, the length of tubes 400A, 400B (3.00 inches) may be longer than the example illustrated in FIGS. 3A and 3B. Further, 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 may be 0.360 inches in length. The third highly flexible region 406A may also include 16 cuts, but may be 0.384 inches in length. 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 may be 0.364 inches in length. Such a configuration essentially "divides" or separates tube 300A into two main portions, namely, a portion including the first highly flexible region 402A, the second highly flexible region 404A, and the third highly flexible region 406A, which includes 49 cuts and extends 1.248 inches, and a second portion including the fourth highly flexible region 408A, the fifth highly flexible region 410A, and the sixth highly flexible region 412A, which includes 42 cuts and extends 1.260 inches. As shown in FIG. 4A, the cut width may vary, such as 0.021 inches between the fine cuts within the second highly flexible region 404A and 0.025 inches between the fine cuts within the fifth highly flexible region 410A. Similarly, the beam width between the cuts may vary, such as 0.009 inches within the second highly flexible region 404A and 0.011 inches within the fifth highly flexible region 410A.

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

[0034] Figures 5A and 5B illustrate representative trunks of tubes 500A, 500B that extend 3.118 inches. Tubes 500A, 500B have trunks that are highly flexible along their entire length where a switchback member is formed, instead of having deflectable or highly flexible regions as illustrated in FIGS. 3 and 4. Different portions of tubes 500A, 500B can be made to have different amounts of flexibility by varying the size, notch width (and thus, center beam width) of the switchback member at different portions of 500A, 500B. As illustrated in FIG. 5A, tube 500A can have cuts in a pattern such that adjacent switchback members exist that extend 2.772 inches along the length of tube 500A. In the example, a first portion 506 of tube 500A can include 10 cuts and extend 0.531 inches, and a second portion 508 of tube 500A can include 11 cuts and extend 0.678 inches. In the second portion 508, the edge of the switchback member can be 0.047 inches, the width of the center beam joining adjacent switchback members can be 0.024 inches, and the notch width of the cuts forming the switchback member can be 0.012 inches.

[0035] More distally, tube 500A can include a third portion 510 that includes 8 cuts and extends 0.536 inches, and a fourth portion 512 that includes 8 cuts and extends 0.536 inches. In the fourth portion 512, the edge of the switchback member can be 0.064 inches, the width of the center beam joining adjacent switchback members can be 0.032 inches, and the notch width of the cuts forming the switchback member can be 0.012 inches. The dimensions of the edge of the switchback member, the width of the center beam, and the notch width can be uniform or vary as needed to achieve the desired degree of deflection of tubes 500A, 500B.

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

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

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

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

[0040] Pulling or manipulating the articulating member 602 can bend different portions of the tube 600 at different angles, such as those illustrated in Figure 6. For example, the smaller the portion of the tube 600, the smaller the angle (e.g., 3.93 degrees, 3.83 degrees, etc.) at which it bends, and the larger portion of the tube 600 can cause it to bend at a larger angle, such as 9.37 degrees.

[0041] Generally, the wider the neutral cutting width of a coarse cut, the more material is being moved when the tube is deflected or bent. This results in a "sharper" bend, allowing the fine cuts to expand (spread), resulting in some "bendability" and allowing the coarse cuts to contract towards each other during the bending operation. The tubes described herein can be designed to reach a target portion of an anatomical structure, such as a renal calyx, including the lower cup, and reaching such an anatomical structure may involve a sharp and forceful rotation of the tube. Thus, as discussed above, different tubes can be designed with different dimensions, such as different cutting widths, different numbers of cuts, or the like, such that the articulation or highly flexible region can bend 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 cut trunk articulation. As illustrated in Figures 7A and 7B, an articulation trunk 700 (e.g., a deflectable trunk, an articulating tube, etc.) with an alternating coarse / fine cut pattern, such as that described above, can be attached to a non-articulating solid or more rigid member 702, such as a scope, a handle, or the like. The articulation trunk 700 can be bent in such a way that the tip 704 of the articulation trunk 700 can be bent from a straight position (180-degree angle) to an angle greater than 270 degrees, as illustrated in Figure 7A, and to an angle greater than 300 degrees, as illustrated in Figure 7B.

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

[0044] Such a pattern can repeat throughout the length of the patterned tube 800. For example, the third highly flexible region 806 and the fifth highly flexible region 810 can 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 can have the same orientation as the second highly flexible region 804. In such an example, each adjacent region will have features that are rotated with respect to each other or offset from each other.

[0045] This enables the patterned tube 800 to operate like a laser-cut helical spring and also enables the patterned tube 800 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) can be bent or deflected in the first plane, and the other regions (the second highly flexible region 804, the fourth highly flexible region 808, and the sixth highly flexible region 812) can be bent in the second plane. Additionally, or alternatively, adjacent switchback members within the same highly flexible region can be rotated relative to each other such that portions of each highly flexible region can be deflected in separate planes.

[0046] Figure 9 illustrates an example of a fine / coarse cut trunk incorporated into endoscope shaft joint motion performance in simulated use. As illustrated in Figure 9, an endoscope 900 with a trunk that employs an alternating cut pattern such as those described herein is illustrated for use in a modeled portion of an anatomical structure 902. The modeled portion of the anatomical structure 902 can represent a portion of a human anatomical structure, such as a renal calyx, into which the endoscope 900 can be inserted during a medical procedure such as renal stone ablation. In the example of Figure 9, the modeled portion of the anatomical structure 902 includes a cavity 904 in which a stone, tumor, or the like can form. The tip of the endoscope 900 can be manipulated or bent around a piece of tissue represented by a rectangular-shaped region of the modeled portion of the anatomical structure 902 such that a procedure such as stone ablation can be performed within the cavity 904 by emitting laser radiation from the tip of the endoscope 900.

[0047] Additional Description and Examples Example 1 is a patterned tube that enables articulation of a medical scope. This patterned tube includes at least one highly flexible region between the proximal end of the patterned tube and the distal end of the patterned tube. The at least one highly flexible region includes a plurality of first cuts having a first cut thickness, a plurality of second cuts having a second cut thickness, where certain ones of the second cuts are located substantially opposite certain ones of the first cuts across the patterned tube and are separated therefrom by a switchback member, and one or more bending moment transmission members. Certain ones of the one or more bending moment transmission members are located between adjacent certain ones of the first cuts and also between adjacent certain ones of the second cuts, connecting adjacent switchback members.

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

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

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

[0051] In Example 5, the subject matter of Example 4 optionally includes 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 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 the tool.

[0052] In Example 6, the subject matter of any one or more of Examples 4 to 5 optionally includes that the articulating member includes a cable or wire.

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

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

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

[0056] In Example 10, the subject matter of any one or more of Examples 1 to 9 optionally includes 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 matter of Example 10 optionally includes that at least a portion of the second highly flexible region is constructed with at least one cut arranged at a rotation angle with respect to at least one cut within the first highly flexible region.

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

[0059] In Example 13, the subject matter of Example 12 optionally includes that 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 to 13 optionally includes 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, the subject matter of any one or more of Examples 1 to 14 optionally includes that at least one of at least a portion of a specific first cut or at least one of a specific second cut tapers 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 highly flexible region and the second highly flexible region including a plurality of first cuts having a first cut thickness, a plurality of second cuts having a second cut thickness, wherein specific ones of the second cuts are located substantially opposite across the tube from specific ones of the first cuts and are separated from the specific ones of the first cuts by a switchback member, and one or more bending moment transmission members, wherein specific ones of the one or more bending moment transmission members are located between adjacent specific ones of the first cuts and also between adjacent specific ones of the second cuts to connect adjacent switchback members.

[0063] In Example 17, the subject matter of Example 16 optionally includes that the neutral thicknesses of the plurality of first cuts and the neutral thicknesses of the 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 matter of Example 17 optionally includes that, in the neutral state, a specific first cut at the distal end of the first highly flexible region is wider than a specific first cut at the proximal end of the first highly flexible region, or a specific second cut at the distal end of the first highly flexible region is wider than a specific second cut at the proximal end of the first highly flexible region, with at least one of these being the case.

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

[0066] Example 20 is a patterned deflectable portion of a medical device shaft, the deflectable portion including a first highly flexible region, a second highly flexible region positioned adjacent the first highly flexible region, and an articulating member mounted to an inner portion of the deflectable portion by at least one guide configured to maintain the position of the articulating member along the highly flexible regions and to enable deflection of at least a portion of the highly flexible regions when the articulating member is retracted by an operating tool. The first highly flexible region and the second highly flexible region include a plurality of first cuts having a first cut thickness, a plurality of second cuts having a second cut thickness, where certain ones of the second cuts are positioned substantially opposite across the deflectable portion from certain ones of the first cuts and are separated therefrom by a switchback member, and one or more bending moment transfer members, where certain ones of the one or more bending moment transfer members are positioned between adjacent certain ones of the first cuts and also between adjacent certain ones of the second cuts, connecting adjacent switchback members.

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

[0068] In Example 22, optionally, at least one of the themes of Examples 20-21 includes that at least a part of the second highly flexible area is constructed with at least one cut arranged at a rotation angle with respect to at least one cut in the first highly flexible area, and the first highly flexible area is formed of a material different from that of the second highly flexible area.

[0069] All publications, patents, and patent documents mentioned in this document are incorporated herein by reference in their entirety as if each were individually cited. In the event of a conflicting use between this document and those documents incorporated by reference, the use in the incorporated citation shall be considered to supplement this document, and in the case of an irreconcilable conflict, the use in this document shall govern.

[0070] In this document, the terms "a" or "an" are used to include one or more than one, as is common in patent documents, independent of any other case or the use of "at least one" or "one or more". In this document, the term "or" is used to indicate non-exclusive, or, unless otherwise stated, "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 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 before such terms in the claim is still considered to fall within the scope of that claim. Further, in the following claims, the terms "first", "second", "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 and not restrictive. For example, the examples described above (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 when reconsidering the above description. The abstract is submitted with the understanding that it is to enable the reader to quickly ascertain the essence of the technical disclosure and is not to be used to interpret or limit the scope or meaning of the claims. Also, in the embodiments for carrying out the above invention, various features may be grouped together to simplify the disclosure. This should not be construed as intending that the disclosed features not claimed are essential to any of the claims. Rather, the subject matter of the invention may be satisfied without all of the features of a particular disclosed embodiment. Accordingly, the following claims are hereby incorporated into the embodiments for carrying out the invention, 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

【Claim 1】 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 comprising: a plurality of first cuts having a first cut thickness; a plurality of second cuts having a second cut thickness, wherein certain ones of the second cuts are located substantially opposite certain ones of the first cuts across the patterned tube and are separated from certain ones of the first cuts by a switchback member; one or more bending moment transfer members, wherein certain ones of the one or more bending moment transfer members are located between adjacent certain ones of the first cuts and further between adjacent certain ones of the second cuts, connecting adjacent switchback members, a patterned tube characterized by comprising:

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