A steering device having a steering unit.

Abstract

The steering device has a flexible tip portion (13, 74, 75) at its distal end. A first steering wire (16(1), 429) is attached to the flexible tip portion (13, 74, 75). The first steering wire (16(1), 429) is part of the tube (3, 102, 103, 121) and is separated from the rest of the tube (3, 102, 103, 121) by a first material removal pattern so that the first steering wire (16(1), 429) extends from the proximal end to the distal end of the steering device. The steering device has a steering unit having a control tube portion (301a(i), 302a(1,3), 431) arranged coaxially with the tube (3).

Description

Technical Field

[0001] The present invention relates to a steerable instrument having a steering unit.

Background Art

[0002] Converting a surgical intervention that requires a large incision to expose a target area into a minimally invasive surgical intervention, i.e., a surgical intervention that requires only a natural opening or a small incision to establish access to the target area, is a well-known ongoing process. Steerable surgical minimally invasive instruments in the fields of gastroscopy, colonoscopy, endoscopy, laparoscopy, etc. are well-known in the art. These invasive instruments may include a steerable tubular device that improves their navigation and steering capabilities. Such a steerable tubular device may include a proximal end portion, a distal end portion including at least one flexible region, and a rigid or flexible intermediate portion or shaft, and the steerable tubular device further includes a steering configuration at its proximal end, and the steering configuration is adapted to bend a flexible region distal to the central axis of the tubular device. The steering configuration may be implemented by a hand-held manual steering device that converts the movement of the arm, wrist and / or finger into the desired movement of the distal portion of the instrument. Alternatively, the steering configuration may be implemented by a robotic device that converts, for example, the rotation of an electric motor into the desired movement of the distal portion of the instrument.

[0003] Most known instruments are complex to manufacture and expensive instruments. In many cases, the distal end of the instrument includes a flexible region consisting of separate links with hinge pins, coils or flexible plastic extrusions. The steering cable is guided through holes in these links and / or through guide tubes, eyes or hooks. Further, the steering configuration typically includes, as a control member, a conventional steering cable having a diameter of, for example, less than 1 mm, and the steering cable is disposed between the associated flexible region at the distal end of the tubular device and the steering configuration at the proximal end.

[0004] Steering cables are often numerous, small, and flexible, and the connection between the wires and robot actuators cannot be performed by the on-site end-user. A more robust means of connecting the equipment to the robot is needed, one that can be easily performed by the operator on-site. Therefore, steerable equipment used in robotic applications share the common feature of having a suitable connection box between the equipment shaft and the robot. The box typically includes mechanical or electromechanical means to convert, for example, the rotation of the robot actuator motor into the correct longitudinal displacement of the equipment's steering cable. Furthermore, the box usually includes a connection interface that facilitates attachment to the robot. These connection boxes are quite complex and expensive to manufacture, and in most cases, they are permanently attached to the equipment by the manufacturer.

[0005] In medical applications, contamination of instruments after use in surgical procedures on a patient can lead to undesirable postoperative complications when used on the next patient. Contamination can result from blood, other bodily fluids, tissues, etc. As a result of contamination, the instrument may contain bacteria, viruses, or other biological or chemical substances that could threaten the health of the next patient to whom the instrument is used.

[0006] One way to avoid this contamination is to thoroughly clean and sterilize the instruments before each use. In many cases, the cleaning process cannot remove all contamination. Therefore, the risk of adverse effects on patients treated with such instruments still exists. Furthermore, the cleaning process is expensive and requires appropriate infrastructure and trained personnel. To prevent the risk of contamination, it is preferable to use disposable instruments that are used once and discarded after treating one patient. However, the high cost of conventional instruments and attached interface boxes forces the reuse of these instruments multiple times in order to keep the instrument cost per procedure at an acceptable level. A further major drawback is that not only the instruments but also the attached interface boxes are discarded after a limited number of uses. Commercially, from the standpoint of waste management and its cost, this is not an optimal solution. Moreover, because interface boxes are usually relatively large, the packaging of such instruments is very bulky, contains a large amount of material, occupies a significant amount of space during transport and storage, further increasing costs and waste problems.

[0007] To enable the commercial viability of these robotic devices for single-use and to minimize waste and transportation and storage space, the steerable devices can be manufactured by pre-assembling hinge structures, steering cables, and other necessary functional components from tubular elements by laser-cutting these components integrally. Further details regarding the design and manufacture of the above-mentioned steerable devices can be found, for example, in International Publication Nos. 2009 / 112060, 2009 / 127236, 2012128618, 201217335a8, 2014011049, 2015084174, 2016089202, 2017010883, and 2017014624. This is explained in International Publication Nos. 2017082720, 2017213491, 2018067004, 2019009710, 2020080938, 2020214027, 2020218920, 2020218921, 2022260518, and 2023287286.

[0008] In combination with this method of constructing the instrument body, interface boxes can be avoided by creating connections between instrument steering wires directly on a fully reusable robot, as proposed in Dutch Patent No. 2030160B1.

[0009] Dutch Patent No. 2030160B1 describes an instrument in which the connection box is obsolete and its functions are entirely transferred to a reusable robot. This is made possible by an implementation of a method of directly coupling the instrument steering element to the robot's actuation output. Attaching the instrument to the robot can be easily done by the end user in the operating room.

[0010] In addition to instruments used in conjunction with robot controllers, maneuverable instruments for minimally invasive surgery can also be used as handheld controlled devices. Instead of a control box for mounting to a robot, these instruments typically include a handle that translates arm, wrist, and / or finger movements into desired movements of the instrument's steering cable. Here again, similar drawbacks arise. Handles can be complex and expensive, and are usually even bulkier than robot connection boxes. The cost per instrument is also usually very high, making single-use unattractive. An example of such an instrument is shown in U.S. Patent Application Publication 2015 / 0107396, which shows an instrument including a permanently mounted handle with an actuation means for flexing the distal portion of the instrument. The limitations and drawbacks of U.S. Patent Application Publication 2015 / 0107396 are as described above. Furthermore, the proposed device is only capable of flexing its distal portion within a single plane.

[0011] Therefore, the category of handheld devices is also covered by International Publication No. 2009 / 112060, International Publication No. 2009 / 127236, International Publication No. 2012128618, International Publication No. 201217335a8, International Publication No. 2014011049, International Publication No. 2015084174, International Publication No. 2016089202, International Publication No. 2017010883, International Publication No. 2017014624, International Publication No. 2017082720, and International Publication No. 2017 Strategies for producing single-use instrument bodies, as described in Brochure No. 213491, International Publication No. 2018067004, International Publication No. 2019009710, International Publication No. 2020080938, International Publication No. 2020214027, International Publication No. 2020218920, International Publication No. 2020218921, International Publication No. 2022260518, and International Publication No. 2023287286, can be leveraged, and these can be combined with reusable handles. Here again, an end-user-operable coupling between the instrument body and the handle is required. While steerable instruments with detachable handles exist, the main drawback of these devices is that steering of the instrument tip is achieved by a wrist-like or ball-joint section at the proximal end of the instrument body to which the steering cable is attached. The instrument is steered by moving the entire handle with wrist and arm movements. Furthermore, the proximal portion of the instrument immediately distal to the steering list needs to be held in place by a second hand or a device such as a guide or trocar so that the instrument can be accurately steered. Generally, the handle does not have means to actuate the individual steering cables by finger movements alone, but the handle can be held stationary.

[0012] Therefore, handheld instruments can also benefit from better solutions for detachable handles, which provide coupling and acting means that allow the instrument to be manipulated solely by finger movements. A coupling such as the one proposed in Dutch Patent No. 2030160B1 can be applied, but in that case the handle still requires a mechanical or electromechanical mechanism that translates finger movements into longitudinal displacement of the coupling fingers.

[0013] The now widely applied principle of simplifying the disposable parts of a steerable device as much as possible and transferring all "complexity" to the reusable parts of the device, which may be a handle or robot, has been the basis of prior art, such as in Dutch Patent No. 2030160B1. "Complexity" here refers to all the means necessary to translate the movement of a motor (robot) or the movement of an operator's arm, wrist, or fingers (handheld) into the correct movement of the steering wire / cable within the steerable device. Thus, a detachable coupling between disposable and reusable parts is assumed to be required at the level of the steering wire / cable itself, which is often not technically feasible. Therefore, current industry standards dictate that robotic devices generally have a connection box attached to the device body, and handheld steerable devices generally have a handle permanently attached to the device body. [Prior art documents] [Patent Documents]

[0014] [Patent Document 1] International Publication No. 2009 / 112060 [Overview of the project] [Means for solving the problem]

[0015] The object of the present invention is to provide a maneuverable instrument for endoscopic and / or invasive type applications that solves or at least reduces at least one of the above-mentioned problems.

[0016] In the first embodiment, this objective is achieved by the steering device described in the attached independent claim 1.

[0017] In such devices, "complexity" is divided between the single-use device body and a reusable handle or robot, so that the main requirements for an optimal solution are addressed. Furthermore, more steering unit components than in conventional technology are simple components fabricated from a small number of tubes into the disposable device itself. The disposable device is easy to manufacture, as compact as possible, requires only a minimum number of interface parts, and secondly, an easy, fail-safe, detachable coupling is established that can be operated by the end user in the field. The coupling may be to a handheld control unit or a robotic control unit.

[0018] Permanently attached connection boxes or handles can be eliminated by transferring all necessary mechanisms required to translate robot controller output or hand, wrist, or finger movements into desired distal end movements to the instrument body itself. Furthermore, the manufacturing cost of such instruments may be potentially low enough that single-use applications of these instruments are commercially viable. Another advantage is that the dimensions of the instruments are much smaller than those of currently available instruments, which has a favorable impact on transport and storage volume, as well as the volume of packaging and instrument waste.

[0019] A favorable embodiment is described in a dependent claim.

[0020] A second aspect of the present invention relates to compensating for differences in path length that may occur between adjacent steering wires due to the bending of the instrument body when a steerable instrument is inserted into a curved channel, such as the intestine, blood vessels, or bronchi in a living organism.

[0021] Apparatus for this second embodiment is described in independent claim 24, and advantageous embodiments are described in dependent claims.

[0022] Further features and advantages of the present invention will become apparent from the description of the invention according to non - limiting and non - exclusive embodiments. These embodiments should not be construed as limiting the scope of protection. Those skilled in the art will understand that other alternative and equivalent embodiments of the present invention can be devised and implemented without departing from the scope of the present invention. Furthermore, distinct features of different embodiments can be combined even if not explicitly shown in the drawings or described herein, provided such combination is not physically impossible. The scope of the present invention is limited only by the claims and their technical equivalents. Embodiments of the present invention are described with reference to the figures of the accompanying drawings, and like or identical reference signs indicate like, identical or corresponding parts.

Brief Description of the Drawings

[0023] [Figure 1] A schematic cross - sectional view of the distal portion of an invasive instrument assembly of the prior art is shown.

[0024] [Figure 2] A schematic view of the distal portions of three prior - art cylindrical elements from which the distal portion of FIG. 1 can be manufactured is shown.

[0025] [Figure 3A] The distal portion of an intermediate cylindrical element of the prior - art instrument of FIGS. 1 and 2 is shown.

[0026] [Figure 3B] The distal portion of an alternative example of an intermediate cylindrical element of such an instrument is shown.

[0027] [Figure 4] The distal portion of an example of an intermediate cylindrical element and an inner cylindrical element inserted into the intermediate cylindrical element in the prior art is shown.

[0028] [Figure 5] An external view of the distal section of a prior - art steerable invasive instrument assembly having two steerable and bendable distal end portions and two proximal flexible control portions is shown.

[0029] [Figure 6] Figure 5 shows a magnified view of the distal tip of the instrument.

[0030] [Figure 7A] Figure 5 shows a cross-sectional view of the invasive instrument.

[0031] [Figure 7B] The distal ends of the inner and intermediate tubes of an alternative embodiment of the double-flexible instrument are shown in 3D.

[0032] [Figure 8] Figures 5 and 7 show examples of how the invasive instruments can be bent. [Figure 9] Same as above.

[0033] [Figure 10] This section describes some basic techniques that can be used to move one or more steering wires longitudinally. [Figure 11] Same as above. [Figure 12] Same as above. [Figure 13A] Same as above. [Figure 13B] Same as above. [Figure 14] Same as above.

[0034] [Figure 15] This shows a configuration that may be used to move a steering wire longitudinally by a tubular element that is rotatable in the tangential direction. [Figure 16A] Same as above. [Figure 16B] Same as above.

[0035] [Figure 17] This shows a configuration that can be used to move two steering wires in opposite longitudinal directions using a tangentially rotatable tubular element. [Figure 18A] Same as above. [Figure 18B] Same as above.

[0036] [Figure 19] This shows a configuration that can be used to move four steering wires longitudinally using two tangentially rotatable tubular elements. [Figure 20A] Same as above. [Figure 20B] Same as above.

[0037] [Figure 21] This configuration illustrates how two steering wires could be moved in opposite longitudinal directions by a tangentially rotatable tubular element, which is driven by a longitudinally shiftable element. [Figure 22A] Same as above. [Figure 22B] Same as above.

[0038] [Figure 23] This configuration shows how four steering wires could be moved longitudinally by two tangentially rotatable tubular elements, both driven by elements that are tangentially rotatable and longitudinally shiftable. [Figure 24] Same as above. [Figure 25A] Same as above. [Figure 25B] Same as above. [Figure 26] Same as above.

[0039] [Figure 27] A configuration is shown in which four steering wires may be used to move longitudinally by two tangentially rotatable tubular elements, both driven by alternative tangentially rotatable and longitudinally shiftable elements. [Figure 28A] Same as above. [Figure 28B] Same as above. [Figure 28C] Same as above. [Figure 28D] Same as above.

[0040] [Figure 29A] The gear configuration is shown. [Figure 29B] Same as above. [Figure 29C] Same as above.

[0041] [Figure 30A] This configuration describes how to move one or more sets of two adjacent longitudinal elements, such as steering wires, longitudinally by moving a single longitudinal control element longitudinally, whose longitudinal movement is controlled by one or more tangentially rotatable tubular elements. [Figure 30B] Same as above. [Figure 31] Same as above.

[0042] [Figure 32A] Several further gear configurations are shown. [Figure 32B] Same as above. [Figure 32C] Same as above. [Figure 32D] Same as above. [Figure 33] Same as above. [Figure 34] Same as above. [Figure 35] Same as above.

[0043] [Figure 36A] This shows an example of connecting disposable devices to two rotating tubes. [Figure 36B] Same as above. [Figure 36C] Same as above.

[0044] [Figure 37] The diagram shows a rotatable or sliding tubular interface of an instrument having teeth for a spur gear and teeth for a worm drive gear, respectively. [Figure 38] Same as above.

[0045] [Figure 39A] A schematic diagram is shown to illustrate the problem of the path length of the steering wire in a multi-flexible device. [Figure 39B] Same as above.

[0046] [Figure 40] An example of a path length compensation solution is shown in a schematic 2D format. [Figure 41] Same as above. [Figure 42] Same as above. [Figure 43] Same as above.

[0047] [Figure 44A] A schematic diagram is shown to illustrate an example of a solution for desired path length compensation in a device having two flexible regions. [Figure 44B] Same as above. [Figure 45] An example of a path length compensation solution is shown in a schematic 2D format.

[0048] [Figure 46A] This paper presents an alternative path length compensation solution for a device with two flexible regions. [Figure 46B] Same as above.

[0049] [Figure 47A] Figure 45 shows a schematic implementation of a path length compensation solution, which is integrated into a steering wire drive mechanism within a pipe that is aligned coaxially and axially. [Figure 47B] Same as above. [Figure 47C] Same as above. [Figure 47D] Same as above. [Figure 47E] Same as above.

[0050] [Figure 48] This paper presents an alternative path length compensation solution for a device with two flexible regions. [Figure 49] Same as above. [Figure 50] Same as above. [Figure 51] Same as above. [Modes for carrying out the invention]

[0051] For the purposes of this specification, the terms cylindrical element and tube may be used interchangeably, i.e., cylindrical element as well as tube refer to a physical entity. The present invention is described with reference to steering wires that are cut from such cylindrical elements and act as push and / or pull steering wires for transmitting the longitudinal movement of a steering wire at the proximal end of the device to the distal end, thereby controlling the bending of one or more flexible distal end portions. They have a strip-like shape and, since they are cut from a tube, have a curved rectangular cross-section as seen tangentially in the steering device.

[0052] Steering mechanism. Figures 1, 2, 3a, and 3b show the distal portion of the device known from International Publication No. 2009 / 112060. The present invention can be applied to this type of device and will therefore be described in detail.

[0053] Figure 1 shows a longitudinal cross-section of the distal section of a conventional steerable device 1, which includes three coaxially arranged cylindrical elements, namely an inner cylindrical element 2, an intermediate cylindrical element 3, and an outer cylindrical element 4. Suitable materials used to form the cylindrical elements 2, 3, and 4 include stainless steel, cobalt-chromium alloy, shape memory alloys such as Nitinol®, plastics, polymers, composites, or other materials that can be formed by material removal processes such as laser cutting or EDM. Alternatively, the cylindrical elements can be fabricated by 3D printing processes or other known material deposition processes.

[0054] The inner cylindrical element 2 includes a first rigid end portion 5 located at the flexible distal end portion 13 of the instrument, a first flexible portion 6, and an intermediate rigid portion 7 located at the intermediate portion 12 of the instrument.

[0055] The outer cylindrical element 4 also includes a first rigid end portion 17, a first flexible portion 18, and an intermediate rigid portion 19. When the inner cylindrical element 2 is inserted into the outer cylindrical element 4, the lengths of portions 5, 6, and 7 of the cylindrical element 2 and the lengths of portions 17, 18, and 19 of the cylindrical element 4 are preferably substantially the same so that these different portions are aligned longitudinally with respect to each other.

[0056] The intermediate cylindrical element 3 also has a rigid end portion 10 located between the corresponding rigid portions 5 and 17 of the two other cylindrical elements 2 and 4 when assembled. The intermediate portion 14 of the intermediate cylindrical element 3 includes one or more separate steering wires 16, which may have different forms and shapes as described below. They are fabricated from the cylindrical element 3 itself and have the form of longitudinal strips. Figure 2 shows three such steering wires 16. After the three cylindrical elements 2, 3 and 4 are assembled, thereby with element 2 inserted into element 3 and the two combined elements 2 and 3 inserted into element 4 (any other order is possible), at least the first rigid end portion 5 of the inner cylindrical element 2, the first rigid end portion 10 of the intermediate cylindrical element 3 and the first rigid end portion 17 of the outer cylindrical element 4 at the distal end of the device are joined to each other, for example, by adhesive or one or more (laser) welding spots.

[0057] In the embodiment shown in Figure 2, the intermediate portion 14 of the intermediate cylindrical element 3 includes a plurality of steering wires 16 having a uniform cross-section, such that the intermediate portion 14 has a general shape and form as shown in the unfolded state of the intermediate cylindrical element 3 in Figure 3a. From Figure 2, it is also clear that the intermediate portion 14 is formed by optionally equally spaced parallel steering wires 16 along the circumference of the intermediate cylindrical portion 3. Advantageously, the number of steering wires 16 is at least three, but any more is possible, so that the instrument is fully controllable in any direction. The number of steering wires 16 may be, for example, four or eight.

[0058] It is observed that the steering wires 16 do not need to have a uniform cross-section along their entire length. They may have widths that vary along their length, and in some cases, at one or more positions, adjacent steering wires 16 are separated only by small slots resulting from laser cutting in the cylindrical element 3. Thus, these wider portions of the steering wires act as spacers to prevent adjacent steering wires 16 from buckling tangentially when pressed. Alternatively, the spacers may be implemented in other ways.

[0059] One embodiment with a spacer is shown in Figure 3b, which shows the distal portions of two adjacent steering wires 16 in an unwinded state. In the embodiment shown in Figure 3b, each steering wire 16 includes portions 64 and 62 that coexist with first flexible portions 6, 18 and intermediate rigid portions 7, 19, respectively. In portions 62 that coincide with the intermediate rigid portions, each pair of adjacent steering wires 16 are in near contact with each other tangentially, and as a result, only a narrow slot exists between them that is just enough to allow the independent movement of each steering wire. The slot arises from the manufacturing process, and its width is determined, for example, by the diameter of the laser beam that cuts the slot.

[0060] In section 61, each steering wire 16 consists of a relatively small flexible section 64 in the circumferential direction, resulting in a substantial gap between each pair of adjacent flexible sections. The flexible sections 64 are provided with several spacers 66 that extend tangentially and almost completely bridge the gap to adjacent flexible sections 64. These spacers 66 suppress the tendency of the steering wire 16 of the flexible section of the instrument to move tangentially, thereby improving tangential control. The exact shape of these spacers 66 is not particularly important, as long as it does not impair the flexibility of the flexible section 64. One or more spacers 66 are attached to the flexible section 64, forming an integral part with the flexible section 64, and may also result from a suitable laser cutting process. They extend to adjacent flexible sections 64 of adjacent steering wires 16.

[0061] In the embodiment shown in Figure 3b, the spacers 66 extend in one tangential direction when viewed from the flexible portion 64 to which they are attached. However, it is also possible to have these spacers 66 extend in both circumferential directions starting from one flexible portion 64. Using this, it is possible to have alternating types of flexible portions 64 when viewed along the tangential direction, the first type having spacers 66 on both sides extending to the next flexible portion, and no spacers 66 in a second intermediate set of flexible portions 64. Otherwise, it is possible to have flexible portions with cams on both sides, and when viewed along the longitudinal direction of the fixture, the cams arising from one flexible portion alternate with the spacers arising from the adjacent flexible portion. It is clear that numerous alternative configurations are available.

[0062] The manufacture of such intermediate components is most conveniently carried out by injection molding or plating techniques, or by starting with a cylindrical tube having the desired inner and outer diameters, and removing the portion of the cylindrical tube wall required to end up with the desired shape of the intermediate cylindrical element 3, for example, by laser or water cutting. However, alternatively, any 3D printing method can be used.

[0063] Material removal can be carried out by a variety of techniques, including conventional cutting techniques such as laser cutting, photochemical etching, deep drawing, drilling or milling, high-pressure waterjet cutting systems, or any suitable material removal process available. Preferably, laser cutting is used because it allows for very precise and clean removal of the material under reasonable economic conditions. The process described above is convenient because it allows the cylindrical element 3 to be manufactured in essentially one process without requiring additional steps to connect different parts of the intermediate cylindrical element, as is required in conventional fixtures where conventional steering cables must be connected to their ends in some way.

[0064] The same type of technique can be used to manufacture the inner cylindrical element 2 and the outer cylindrical element 4, each having its respective flexible portions 6, 18. These flexible portions 6, 18 can be manufactured as hinges resulting from cutting out any desired pattern from the cylindrical element, for example, by using one of the methods described on page 5, lines 15-26 of European Patent Application No. 08004373.0 filed on March 10, 2008, but any other suitable process can be used to produce the flexible portions.

[0065] Figures 4 to 9 show that the device components are known from the prior art publication internationally, No. 2020 / 214027. The present invention can also be applied to these devices.

[0066] Figure 4 shows an exemplary embodiment of a longitudinal (steering) element 16 obtained after providing longitudinal slots 70 in the wall of the intermediate cylindrical element 3. Here, the steering wire 16 is at least partially helical around the longitudinal axis of the instrument such that the end portion of each steering wire 16 in the proximal part of the instrument is positioned in a different angular direction around the longitudinal axis than the end portion of the same steering wire 16 in the distal part of the instrument. If the steering wire 16 were positioned linearly, bending of the instrument in the proximal part in a particular plane would result in bending of the instrument in the distal part in the same plane but 180 degrees opposite. This helical structure of the steering wire 16 allows for the effect that bending of the instrument in the proximal part in a particular plane may result in bending of the instrument in the distal part in a different plane or in the same plane but in the same direction. A preferred helical structure may be such that the ends of each steering wire 16 in the proximal portion of the device are positioned in an orientation that is angularly shifted by 180 degrees around the longitudinal axis relative to the same end of the steering wire 16 in the distal portion of the device. However, any other angularly shifted orientation, such as 90 degrees, is within the scope of this specification. The slots 70 are sized such that, when positioned in a given location within the steerable device, the movement of the steering wire is guided by the adjacent steering wire. However, particularly in the flexible region 13 of the device, the width of the steering wire 16 may be smaller to provide the device with the necessary flexibility / bendability at this location.

[0067] Figure 5 provides a detailed perspective view of the distal portion of one embodiment of an extendable tubular body 76 of a steerable device having two flexible distal flexible regions 74, 75. Figure 5 shows that the extendable tubular body 76 includes several coaxially arranged layers or cylindrical elements, including an outer cylindrical element 104 that terminates after the first distal flexible region 74 at the distal end portion 13. The distal end portion 13 of the outer cylindrical element 104 is fixedly attached to the cylindrical element 103 located inside and adjacent to the outer cylindrical element 104, for example, by (laser) welding at a welding spot 100. However, any other suitable mounting method may be used, including any mechanical snap-fit ​​connection or bonding with a suitable adhesive.

[0068] Figure 6 provides a more detailed view of the distal end portion 13, showing that in this embodiment the distal end portion 13 includes three coaxially arranged layers or cylindrical elements, namely an inner cylindrical element 101, a first intermediate cylindrical element 102, and a second intermediate cylindrical element 103. The distal ends of the inner cylindrical element 101, the first intermediate cylindrical element 102, and the second intermediate cylindrical element 103 are all fixedly attached to each other. This can be done by (laser) welding at welding spots 100. However, any other suitable attachment method can be used, including any mechanical snap-fit ​​connection or bonding with a suitable adhesive. The attachment points may be located on the edges of the inner cylindrical element 101, the first intermediate cylindrical element 102, and the second intermediate cylindrical element 103, as shown in the figure. However, these attachment points may also be located at a distance from these edges, preferably between the edges and the location of the flexible region 75.

[0069] It will be apparent to those skilled in the art that the elongated tubular body 76 shown in Figure 5 includes a total of four cylindrical elements. The elongated tubular body 76 according to the embodiment shown in Figure 5 includes two intermediate cylindrical elements 102 and 103 on which steering members of a steering configuration can be arranged. However, more or fewer cylindrical elements may be provided as needed.

[0070] An exemplary actual configuration of the steering member is shown in Figure 7A, which provides a schematic longitudinal cross-sectional view of an exemplary embodiment of the elongated tubular body 76 as shown in Figure 5.

[0071] In this embodiment, the flexible regions 74 and 75 are implemented by providing slits 74a and 75a in each cylindrical element, respectively. These slits 74a and 75a can be arranged in any suitable pattern so that the flexible regions 74 and 75 have the desired flexibility in the longitudinal and tangential directions according to the desired design.

[0072] Figure 7A shows longitudinal cross-sections of the four layers or cylindrical elements described above, namely the inner cylindrical element 101, the first intermediate cylindrical element 102, the second intermediate cylindrical element 103, and the outer cylindrical element 104.

[0073] The inner cylindrical element 101 includes a rigid ring 111 positioned at the distal end portion 13 of the steerable instrument 10, a first flexible portion 112, a first intermediate rigid portion 113, a second flexible portion 114, and a second intermediate rigid portion 115, as seen along its length from the distal end to the proximal end of the instrument.

[0074] The first intermediate cylindrical element 102 includes a rigid ring 121, a first flexible portion 122, a first intermediate rigid portion 123, a second flexible portion 124, and a second intermediate rigid portion 125, as seen along its length from the distal end to the proximal end of the instrument. The portions 122, 123, 124, and 125 together form a steering wire 16(1) that can move longitudinally like a wire. The longitudinal dimensions of the rigid ring 121, first flexible portion 122, first intermediate rigid portion 123, second flexible portion 124, and second intermediate rigid portion 125 of the first intermediate element 102 are aligned with, preferably substantially equal to, the longitudinal dimensions of the rigid ring 111, first flexible portion 112, first intermediate rigid portion 113, second flexible portion 114, and second intermediate rigid portion 115 of the inner cylindrical element 101, and also coincide with these portions. In this specification, “substantially equal” means that the respective identical dimensions are equal by less than 10%, preferably less than 5%.

[0075] Similarly, the first intermediate cylindrical element 102 includes one or more other steering wires 16(2).

[0076] The second intermediate cylindrical element 103 includes a first rigid ring 131, a first flexible portion 132, a second rigid ring 133, a second flexible portion 134, and a first intermediate rigid portion 135, as seen along its length from the distal end to the proximal end of the instrument. Portions 133, 134 and 135 and 136 together form a steering wire 130(1) that can move longitudinally like a wire. The longitudinal dimensions of the first flexible portion 132, along with the first rigid ring 131 and the second rigid ring 133, as well as the second flexible portion 134 and the first intermediate rigid portion 135 of the second intermediate cylinder 103, are aligned with, preferably substantially equal to, the longitudinal dimensions of the rigid ring 111, the first flexible portion 112, the first intermediate rigid portion 113, the second flexible portion 114, and the second intermediate rigid portion 115 of the first intermediate element 102, respectively, and coincide with these portions.

[0077] Similarly, the second intermediate cylindrical element 103 includes one or more other steering wires, one of which is shown in reference to reference no. 130(2).

[0078] The outer cylindrical element 104 includes a first rigid ring 141, a first flexible portion 142, and a first intermediate rigid portion 143, as seen along its length from the distal end to the proximal end of the instrument. The longitudinal dimensions of the first flexible portion 142 and the outer cylindrical element 104 are aligned with, preferably substantially equal to, the longitudinal dimensions of the second flexible portion 134 and the first intermediate rigid portion 135 of the second intermediate element 103, respectively, and coincide with these portions. The rigid ring 141 may have substantially the same length as the rigid ring 133 and is fixedly attached thereby, for example, by spot welding or adhesive. The rigid rings 111, 121, and 131 are attached to each other by spot welding or adhesive, for example. This may be done at their edges, but may also be done away from these edges.

[0079] The inner and outer diameters of the cylindrical elements 101, 102, 103, and 104 are selected such that, at the same position along the elongated tubular body 76, the outer diameter of the inner cylindrical element 101 is slightly smaller than the inner diameter of the first intermediate cylindrical element 102, the outer diameter of the first intermediate cylindrical element 102 is slightly smaller than the inner diameter of the second intermediate cylindrical element 103, and the outer diameter of the second intermediate cylindrical element 103 is slightly smaller than the inner diameter of the outer cylindrical element 104, allowing for sliding movement of adjacent cylindrical elements relative to each other. Dimensioning should be such that a sliding fit is provided between adjacent elements. The clearance between adjacent elements may generally be around 0.02 to 0.1 mm, but depends on the specific application and the material used. The clearance may be smaller than the wall thickness of the steering wire to prevent overlapping configurations. Limiting the clearance to about 30% to 40% of the wall thickness of the steering wire is generally sufficient.

[0080] The use of the structure described above makes it possible to use the steering device 10 in a double-bend configuration. The operating principle of this structure will be explained with reference to the examples shown in Figures 8 and 9.

[0081] For convenience, as shown in Figures 7A, 8, and 9, the different parts of the cylindrical elements 101, 102, 103, and 104 are grouped into regions 151 to 155, defined as follows: Region 151 includes the rigid rings 111, 121, and 131. Region 152 includes parts 112, 122, and 132. Region 153 includes the rigid rings 133 and 141 and parts 113 and 123. Region 154 includes parts 114, 124, 134, and 142. Region 155 includes parts 115, 125, 135, and 143.

[0082] By pushing / pulling the steering wires 130(1) and 130(2) in the longitudinal direction of the device, one side of the attached rigid rings 133 / 141 can be moved in either the proximal or distal direction of the device, while the tangential side of the device opposite to these attached rigid rings 133 / 141 can be moved in the opposite direction, resulting in deflection of the device in the flexible region 154 as shown in Figure 8.

[0083] When three or more steering wires are applied per set 130(j) (j=1, 2, 3, ...J), preferably equally spaced tangentially, the flexible region 154 can be bent in any desired direction.

[0084] By pushing / pulling the steering wires 16(1) and 16(2) in the longitudinal direction of the device, one side of the attached rigid rings 121 / 131 can be moved in either the proximal or distal direction of the device, while the opposite tangential side of the device can be moved in the opposite direction, resulting in deflection of the device in the flexible region 154 as shown in Figure 8.

[0085] If three or more steering wires per set 16(i) are preferably applied equally tangentially and spaced apart, the flexible region 152 can be deflected in any desired direction.

[0086] The fact that regions 152 and 154 can flex independently of each other makes it possible to give the distal end portion 13 of the steering device independent positions and longitudinal directions. In particular, the distal end portion 13 can take an advantageous S-shape. Those skilled in the art will understand that the ability of regions 152 and 154 to flex independently of each other greatly improves the maneuverability of the distal end portion 13, and therefore the steering device as a whole.

[0087] Clearly, the length of the flexible portion shown in Figures 7A to 9 can be changed to accommodate specific requirements regarding the bending radius and overall length of the distal end portion 13 and the proximal end portion 11 of the steering device.

[0088] In the illustrated embodiment, the steering wire includes one or more sets of steering wires that form an integral portion of one or more intermediate cylindrical elements 102, 103. Preferably, the steering wire includes the remaining portion of the walls of the intermediate cylindrical elements 102, 103 after longitudinal slits are provided in the walls of the intermediate cylindrical elements 102, 103 that define the remaining steering wire.

[0089] Figures 7A, 8, and 9 show one embodiment in which steering wires 16(1) and 16(2) for bending the most distal flexible region 75 are fabricated in a separate tube from the steering wires 130(1) and 130(2) for bending the flexible region 74. However, all such steering wires may be fabricated in a single tube, as shown in Figure 7B, where reference numeral 130 is replaced by reference numeral 16. Figure 7B shows that four of the eight steering wires in total, 16(1) to 16(4), are fabricated in a tube 102. Figure 7B shows how the rigid rings 111 and 121 are attached to each other at one or more attachment points 170, for example, by (laser) welding or bonding. Figure 7B also shows that steering wires 16(1) and 16(3) are attached to the rigid ring 121 (the same applies to steering wires 16(5) and 16(7), although they are not visible in Figure 7B). The distal ends of steering wires 16(2), 16(4) (and 16(6) and 16(8)) are attached to the intermediate rigid section 113 at attachment point 172, for example, by (laser) welding or bonding.

[0090] As can be understood from the above description, the flexible portion 112 can be bent by pulling / pushing the steering wires 16(1), 16(3), 16(5), and 16(7), and the flexible portion 114 can be bent by pulling / pushing the steering wires 16(2), 16(4), 16(6), and 16(8).

[0091] Steering unit

[0092] The following describes embodiments of instruments, handheld and robotic actuators, and coupling methods that improve cost-effectiveness, enable single-use of instruments, and thus reduce the incidence of postoperative complications associated with instrument reuse. Furthermore, the volume of disposable instruments is significantly reduced, which has a desirable effect on storage and shipping volume as well as waste volume.

[0093] The following embodiments illustrate instrument and handle and robot interfaces, where the "complexity" is divided between single-use instruments and reusable handles or robots, so that the main requirements for an optimal solution are addressed. Firstly, the disposable instruments are easy to manufacture, as compact as possible, and require only the minimum number of interface components; secondly, an easy, fail-safe, and detachable coupling is established that can be operated by the end user in the field.

[0094] The equipment is available in the following publications: International Publication No. 2009 / 112060, International Publication No. 2009 / 127236, International Publication No. 2012128618, International Publication No. 201217335a8, International Publication No. 2014011049, International Publication No. 2015084174, International Publication No. 2016089202, International Publication No. 2017010883, International Publication No. 2017014624, and International Publication No. 2017082720. It can be manufactured as proposed in International Publication Nos. 2017213491, 2018067004, 2019009710, 2020080938, 2020214027, 2020218920, 2020218921, 2022260518, and 2023287286. These applications propose apparatus in which the required parts and features are manufactured by laser cutting the parts from the walls of one or more tubes and left in a pre-assembled state. The only additional manufacturing step is to slide a number of tubes together and to attach the layers of tubes to each other at the required positions. Once this method is implemented, it is also very easy to laser cut additional parts from the same layers of tubes with little additional cost.

[0095] For example, International Publication No. 2022260518 illustrates a mechanism used to compensate for the length of a longitudinal member within a flexible instrument body to prevent the distal end of the instrument from being actuated (bent) when the flexible instrument body is guided through a curved channel. International Publication No. 2022260518 describes the use of tubular components, including slots and sliding members, for that purpose. Slots and sliding members may also be used for the direct or indirect actuation of steering wires and / or other longitudinal control elements for other purposes in steerable instruments, as described below.

[0096] U.S. Patent Application Publication 2015 / 0107396 demonstrates that a steering wire can be actuated by a groove, but this application merely describes a conventional solution in which the apparatus and handle are assembled from many individual parts and the handle is permanently attached to the apparatus body. U.S. Patent Application Publication 2015 / 0107396 also only describes an actuation element including a groove for steering wire actuation, having a rotation axis intersecting the longitudinal axis of the apparatus body. Furthermore, U.S. Patent Application Publication 2015 / 0107396 is limited to an apparatus in which the distal portion can be bent in only two directions within a single bending plane.

[0097] The following describes an example of a solution that avoids the permanent installation of a handheld handle or junction box by coupling individual steering wires with the actuating mechanisms, allowing end-users to perform the operation on-site.

[0098] Figure 10 shows one embodiment of a device having three, or actually more, coaxial tubes, namely an inner tube 2, an intermediate tube from which steering wires 16(i) are fabricated, and an outer tube 203. The device has a central axis 229. Each proximal end portion of the steering wire 16(i) is provided with one or more pins 221(i) extending radially from the device through longitudinal slots 205(i) in the outer tube 203. One or more pins 221(i) are fixed to the steering wire 16(i). Each of such pins 221(i) may be connected to or attached to an appropriate drive component so as to move individual steering wires 16(i) to flex the flexible end portion of the device. The drive component may be manually controlled or controlled by a robotic device.

[0099] Figure 11 shows one embodiment of a steering unit of an instrument equipped with four steering wires 16(i), although any other suitable number may be used instead. The outer tube 203 is provided with four longitudinal slots 205(i), each slot tangentially aligned with one steering wire. However, these four different longitudinal slots 205(i) are longitudinally offset from one another. For each longitudinal slot 205(i), a ring 223(i) has an inner diameter slightly larger than the outer diameter of the outer tube 203 so that the ring 223(i) can slide axially along the outer tube 203. Furthermore, each ring 223(i) is attached to the associated steering wire 16(i) via the longitudinal slot 205(i) by a pin-shaped component such as the pin 221(i) shown in Figure 10, for example. Each ring 223(i) has a radially extending pin 225(i). Each of the rings 223(i) or pins 225(i) may be connected to or attached to a suitable drive component so as to move individual steering wires 16(i) to flex the flexible end portion of the device. The drive component may be manually controlled or controlled by a robotic device.

[0100] Figure 12 shows a modified embodiment of the steering unit of Figure 11. Here, the ring 223(i) with an extending pin 225(i) is replaced by rings 227(i) with two radially extending flanges 228(i) per ring 227(i). The two flanges 228(i) are positioned at a predetermined longitudinal distance from each other so as to define a circumferential groove together with the rings 227(i). Again, the outer tube 203 is provided with four or any other suitable number of longitudinal slots 205(i), each tangentially aligned with one steering wire 16(i), and these longitudinal slots 205(i) are longitudinally offset from each other. Each ring 227(i) has an inner diameter slightly larger than the outer diameter of the tube 203 so that the ring 227(i) can slide along the outer tube 203. Furthermore, each ring 227(1) is attached to the associated steering wire 16(i) via a longitudinal slot 205(i) by a pin-shaped component such as the pin 221(i) shown in Figure 10, or by another mounting means such as welding or bolts / screws.

[0101] To enable coupling to a controller, such a controller may be provided with sliders configured to be inserted into grooves defined by a ring 227(i) and a flange 228(i), so that any longitudinal movement of the sliders within the controller results in longitudinal movement of the steering wire 16(i). The controller may have as many sliders as there are steering wires 16(i) to enable independent control of the steering wires 16(i). Such circumferential grooves facilitate alignment between each slider and its associated steering wire 16(i), as only longitudinal alignment is required. Tangential alignment is handled in this embodiment by grooves defined by the ring 227(i) and the flange 228(i). Furthermore, when coupled to the controller, the sliders remain within their associated grooves defined by the ring 227(i) and the flange 228(i), so the device can rotate freely relative to the controller.

[0102] Figures 13A and 13B show one embodiment of a steering unit having a ring 231(i) with internal threads 233(i). Although Figures 13A and 13B show only one such ring 231(i), there is one ring 231(i) for each steering wire 16(i). The outer tube 203 is provided with longitudinal slots 205(i) and longitudinally aligned threads 234(i) for each steering wire 16(i). The threads 233(i) of each ring 231(i) are screwed into the threads 234(i) of the outer tube 203. A pin 221(i) is attached to the steering wire 16(i), and this pin 221(i) extends through the longitudinal slots 205(i) into a circumferential groove 232(i) on the inside of the ring 231(i). The outer surface of the ring 231(i) is provided with pins 236(i). Figure 13B is a cross-sectional view taken through a plane passing through the longitudinal slot 205(i) and the center line XIII passing through the central axis 229.

[0103] Rotating the ring 231(i) around the outer tube 203 moves the ring 231(i) along the longitudinal direction of the device 1. Next, the groove 232(i) rotates around the pin 221(i), moving the pin 221(i) and therefore the steering wire 16(i) along the longitudinal direction of the device. The controller is mounted to be connected to the pin 236(i) so as to be configured to rotate the ring 231(i) and move the steering wire 16(i) along its longitudinal direction.

[0104] As an alternative to pin 236(i), the outer surface of ring 231(i) may be provided with a toothed structure configured to cooperate with a suitable drive wheel in the controller (see Figure 37). As a further alternative, a worm gear structure may also be used to drive the rotation of ring 231(i) (see Figure 38).

[0105] Figure 14 shows a further alternative configuration of a possible coupling mechanism between the steering wire 16(i) and the controller. Here, the steering wire 16(i) is provided with one or more sets of consecutive openings 235(i). Instead of the openings 235(i), grooves or teeth, such as structures, may be used; for example, an involute gear cam may be used with a corresponding involute gear wheel. For each steering wire 16(i), a gear 237(i) is provided in the controller. The coupling of the device can be achieved by having the gear 237(i) at a precise fixed radial position to engage with the opening 235(i) or toothed cam at the end of the steering wire 16(i). For example, by disconnecting the gear 237(i) from the drive motor so that it can rotate freely using a mechanical or electromechanical clutch, the device can be inserted until the gear 237(i) and the steering wire end are fully engaged. At that point, the gear clutch can be engaged and the gear can be driven by the actuator motor. It is also possible to mount the gears on a slider to which a radial force has been pre-applied, allowing the gears to be opened and closed radially. Engagement between the gear teeth and the steering wire 16(i) can be achieved by rotating the gears until they engage. In the coupled state between the device and the controller, all gears 237(i) are arranged and configured to cooperate with one or more consecutive sets of openings 235(i) of the steering wire 16(i). The longitudinal movement of the steering wire 16(i) can be controlled individually.

[0106] The examples in Figures 10 to 14 illustrate simple solutions for mounting individual steering wires, characterized by their ease of coupling, which allow each individual steering wire to be coupled to an actuation mechanism, such as a robot actuation mechanism using a linear motor or rotary motor. A drawback of these solutions may be that they require individually manufactured and assembled parts. Furthermore, each individual steering wire coupling mechanism must be actuated by an individual actuation mechanism in a robot or handheld handle.

[0107] Other alternative solutions requiring fewer individually manufactured parts and fewer actuator inputs are presented below. Furthermore, these parts can all be manufactured from one or more tubes by providing one or more appropriate material removal patterns in these tubes.

[0108] One alternative method for operating a single steering wire 16(1) is schematically shown in Figure 15. A sliding member 301(1) is configured within the steering unit to move only up and down. The sliding member 301(1) has a slit-shaped opening 303(1), and the steering wire 16(1) is provided with a pin 305(1) that is housed in the slit-shaped opening 303(1). The slit-shaped opening 303(1) is positioned at an angle α with respect to the longitudinal direction of the steering wire 16(1), where 0 < α < 90 degrees. When the sliding member 301(1) moves downward as indicated by arrow F1, the steering wire 16(1) moves to the right in the direction of the longitudinal axis of the device as indicated by arrow F2. When the sliding member 301 moves upward, the steering wire 16(1) moves to the left.

[0109] Figures 16A and 16B are from the following publications: International Publication No. 2009 / 112060, International Publication No. 2009 / 127236, International Publication No. 2012128618, International Publication No. 2012173478, International Publication No. 2014011049, International Publication No. 2015084174, International Publication No. 2016089202, International Publication No. 2017010883, International Publication No. 2017014624, International Publication No. 2017082720, International Publication No. 2017213491. Assuming that the manufacturing methods described in International Publication Nos. 2018067004, 2019009710, 2020080938, 2020214027, 2020218920, 2020218921, 2022260518, and 2023287286 are employed, one embodiment is shown of how the steering unit of Figure 15 can be incorporated into an instrument as a very easy-to-fabricate and compact solution. The embodiments of Figures 16A and 16B can be fabricated by creating appropriate material removal patterns in the four tubes. In Figures 16A and 16B, all components with reference numbers having the subscript "a" have the same function as the components with the same reference numbers without the subscript "a" in Figure 15.

[0110] The intermediate tube has, for example, four steering wires 16(i), and the mechanism in Figure 15 is shown to be applied to one of them. The outer tube 203 is provided with longitudinal slots 309(i) (one for each steering wire 16(i)), which are aligned tangentially with each steering wire 16(i). A sliding pin 307(i) is provided within the longitudinal slot 309(i). The sliding pin 307(i) is attached to the steering wire 16(i) and can move freely in the longitudinal direction of the longitudinal slot 309(i). That is, the sliding pin 307(i) is guided longitudinally by the longitudinal slot 309(i) and can move only in the direction of the desired steering wire.

[0111] To complete the steering mechanism, only one additional tube needs to be added around the outer tube 203. The distal ring 321, fabricated from this additional tube, is attached to the outer tube 203 distal to the longitudinal slot 309(i), and the proximal ring 323 is attached to the outer tube 203 proximal to the longitudinal slot 309(i).

[0112] As shown in Figure 16B, the additional tube includes a control tube section 301a(i) which includes a helical slot 303a(i) and a sliding pin 305a(i) inside the helical slot 303a(i). The control tube section 301a(i) can rotate around the outer tube 203 between the distal ring 321 and the proximal ring 323, but cannot move longitudinally between the distal ring 321 and the proximal ring 323, apart from some possible play arising from the manufacturing process. The sliding pin 305a(i) is attached to the sliding pin 307(i) inside the outer tube 203, and as a result, the sliding pin 305a(i) is also attached to the steering wire 16(i). As the control tube section 301a(i) rotates around the coaxially arranged instrument, the helical slot 303a(i) acts both the sliding pins 307(i) and 305a(i) longitudinally. In this way, a simple, compact, and easy-to-manufacture solution is provided for attaching individual steering wires to simple coupling elements that can be directly rotated, for example, by an electrically actuated motor in a robot arm.

[0113] This mechanism does not need to be manufactured as separate parts requiring individual assembly, but here it may be pre-assembled into several tubes, for example, by (laser) cutting in a single piece, as described in International Publication No. 2016089202. Pins 305a(i) are fabricated from tubes 321 / 323, and 307(i) are fabricated from tube 203, for example, by (laser) cutting or any other material removal technique. A method for establishing the connection between the rotatable control tube portion 301a(i) and the rotary actuation element in such motor or handheld handle will be described further below in this specification.

[0114] For each steering wire 16(i), a separate steering mechanism including rings 321, 323 and control tube section 301a(i) may be provided to provide separate steering control for all steering wires 16(i). However, the control tube section 301a(i) may be arranged to control the longitudinal movement of two or more steering wires 16(i). This is possible, for example, because the apparatus may be designed so that each steering wire 16(i) has an opposing steering wire, i.e., is located 180 degrees tangentially rotated within the apparatus. In such a configuration, the two opposing steering wires 16(i) move in opposite longitudinal directions along the same distance when their flexible ends are operated to bend.

[0115] When applying the principles of Figures 16A and 16B, one embodiment as shown in Figure 17 can also be considered. In Figure 17, the same reference numerals used in Figure 15 refer to the same components. In addition to Figure 15, Figure 17 shows two steering wires 16(1) and 16(3). It is assumed that steering wire 16(3) is positioned 180 degrees tangentially to steering wire 16(1). The steering unit includes a single sliding member 302(1,3) having a slit-shaped opening 303(1) for steering wire 16(1) and an additional slit-shaped opening 303(3) for steering wire 16(3). A pin 305(3) is attached to steering wire 16(3) and accommodated in the slit-shaped opening 303(3). The slit-shaped opening 303(3) is positioned at an angle β with respect to its longitudinal axis. In most practical cases, α = β. Here, when the sliding member 302(1,3) is moved downward as indicated by arrow F1, steering wire 16(1) moves to the right as indicated by arrow F2, and steering wire 16(3) moves to the left as indicated by arrow F3. When α=β, steering wires 16(1) and 16(3) move in opposite directions along the same length, such that one generates a tensile force and the other generates a compressive force, and thus flexes its end. The two steering wires 16(1) and 16(3) are actuated simultaneously by a single control element.

[0116] Figures 18A and 18B show an implementation of the steering unit of Figure 17 in a device manufactured from several tubes, where two steering wires allow the device tip to move in two directions within one plane, provided that the slots are configured to move the two actuated steering wires in opposite directions. Naturally, the slots can be shaped so that any desired acting direction and magnitude can be established when the tube containing the slots is rotated. Embodiments of Figures 18A and 18B can be manufactured by creating appropriate material removal patterns in four tubes. In Figures 18A and 18B, all components with reference numbers having the subscript "a" have the same function as components with the same reference numbers without the subscript "a" in Figure 17.

[0117] As shown in Figure 18A, the intermediate tube 3 has, for example, four equidistant steering wires 16(i). The outer tube 203 is provided with longitudinal slots 309(i) (one for each steering wire 16(i)), which are aligned tangentially with each steering wire 16(i). Sliding pins 307(i) are provided within the longitudinal slots 309(i). The sliding pins 307(i) are attached to the steering wires 16(i) and can move freely in the longitudinal direction of the longitudinal slots 309(i). That is, the sliding pins 307(i) are guided longitudinally by the longitudinal slots 309(i) and can move only in the direction of the desired steering wire.

[0118] The steering wire 16(3), longitudinal slot 309(3), and sliding pin 307(3) are explicitly shown in Figure 18A. The steering wire 16(1) is located on the opposite side of the steering wire 16(3), i.e., rotated 180 degrees tangentially, and is not visible in Figure 18A. The outer tube 203 has the longitudinal slot 309(1), and the sliding pin 307(1) is located on the opposite side, but closer to the proximal (right) end of the device than the longitudinal slot 309(3).

[0119] To complete the steering mechanism for the steering wires 16(1) and 16(3), only one additional tube needs to be added around the outer tube 203. A first ring 321 made from this additional tube is attached to the outer tube 203 distal to the longitudinal slot 309(3), and a second ring 323 is attached to the outer tube 203 proximal to the longitudinal slot 309(1).

[0120] As shown in Figure 18B, the additional tube includes a control tube section 302a(1,3) which includes a helical slot 303a(3) and a sliding pin 305a(3) within the helical slot 303a(3). The control tube section 302a(1,3) further includes a helical slot 303a(1) and a sliding pin 305a(1) (not visible) provided in the helical slot 303a(1). The helical slots 303a(1) and 303a(3) spiral in opposite directions. The control tube section 302a(1,3) can rotate around the outer tube 203 between the first ring 321 and the second ring 323, but cannot move longitudinally between the first ring 321 and the second ring 323, apart from some possible play arising from the manufacturing process. Sliding pins 305a(1) and 305a(3) are attached to sliding pins 307(1) and 307(3) in the outer tube 203, respectively, and sliding pins 305a(1) and 305a(3) are also attached to steering wires 16(1) and 16(3), respectively. When the control tube section 302a(1,3) rotates around the coaxially arranged device as indicated by reference numeral R1, the helical slots 303a(1) and 303a(3) actuate both the attached sliding pins 307(1) and 305a(1) and the attached sliding pins 307(3) and 305a(3), respectively, in longitudinal but opposite directions, the principle of which has been explained with reference to Figure 17.

[0121] In this way, a simple, compact, and easily manufactured solution is created for attaching individual pairs of steering wires to a single, simple coupling element that can be directly rotated by, for example, an electrically actuated motor in a robotic arm. This mechanism does not need to be manufactured as separate parts requiring individual assemblies, but here it can be, for example, integrally (laser) cut and pre-assembled into several tubes, as described in International Publication No. 2016089202. A method for establishing the connection between the rotatable control tube section 302a(1,3) and the rotary actuating element in such motor or handheld handle will be described further below in this specification.

[0122] Figure 19 shows an example of a steering unit obtained when two mechanisms, such as the one shown in Figure 17, each having a single control tube section, are used to control the longitudinal movement of two pairs of opposing steering wires 16(i).

[0123] In this way, for example, a second pair of steering wires 16(i) that steers their tip in a plane perpendicular to the first steering plane associated with the first pair of steering wires 16(i) can be actuated in a second rotatable control tube section. The steering mechanism for the second pair of steering wires 16(i) can be easily added without significant extra cost or effort by cutting a second assembly of the mechanism, as shown in Figures 18A and 18B, into the same part of an additional tube located around the outer tube 203. This only adds an additional tube of a limited length at a very low material cost and only increases the (laser) cutting time by a few seconds.

[0124] In Figure 19, all the same reference numbers as in Figure 17 relate to the same components. Additional reference numbers are discussed here.

[0125] In addition to Figure 17, Figure 19 shows two steering wires 16(2) and 16(4). Assume that steering wire 16(4) is positioned tangentially rotated 180 degrees relative to steering wire 16(2). The mechanism includes a further sliding member 302(2,4) having a slit-shaped opening 303(2) for steering wire 16(2) and an additional slit-shaped opening 303(4) for steering wire 16(4). Pins 305(2) and 305(4) are attached to steering wires 16(2) and 16(4), respectively, and housed in the slit-shaped openings 303(2) and 303(4), respectively. The slit-shaped openings 303(2) and 303(4) are positioned at angles γ and δ, respectively, with respect to their longitudinal axes. In the most practical case, α=β=γ=δ. Here, when the sliding member 302(2,4) is moved downward as indicated by arrow F6, steering wire 16(4) moves to the right as indicated by arrow F5, and steering wire 16(2) moves to the left as indicated by arrow F4. When γ=δ, steering wires 16(2) and 16(4) will move in opposite directions along the same length such that one generates a tensile force and the other generates a compressive force, and thus their ends bend. The two steering wires 16(2) and 16(4) are actuated simultaneously.

[0126] Figures 20A and 20B show an implementation of the steering unit of Figure 19 in a device manufactured from several tubes, where four steering wires allow the device tip to move in all directions. Naturally, the slots can be shaped so that any desired operating direction and size can be established when the tube containing the slots is rotated. The embodiments of Figures 20A and 20B can be manufactured by creating appropriate material removal patterns in the four tubes. In Figures 20A and 20B, all components with reference numbers having the subscript "a" have the same function as the components with the same reference numbers without the subscript "a" in Figure 19.

[0127] As shown in Figure 20A, the intermediate tube 3 has, for example, four equidistant steering wires 16(i). The outer tube 203 is provided with longitudinal slots 309(i) (one for each steering wire 16(i)), which are aligned tangentially with each steering wire 16(i). Thus, the longitudinal slots 309(i) are also located at equidistant positions tangentially. A sliding pin 307(i) is provided within the longitudinal slot 309(i). The sliding pin 307(i) is attached to the steering wire 16(i) and can move freely in the longitudinal direction of the longitudinal slot 309(i). That is, the sliding pin 307(i) is guided longitudinally by the longitudinal slot 309(i) and can move only in the direction of the desired steering wire.

[0128] The steering wires 16(3) and 16(4), the longitudinal slots 309(3) and 309(4), and the sliding pins 307(3) and 307(4) are explicitly shown in Figure 20A. The steering wires 16(1) and 16(2) are located opposite the steering wires 16(3) and 16(4), respectively, i.e., rotated 180 degrees tangentially, and are not visible in Figure 20A. The outer tube 203 has a longitudinal slot 309(1) with a sliding pin 307(1) located opposite the longitudinal slot 309(3) but closer to the proximal (right) end of the device, and a longitudinal slot 309(2) with a sliding pin 307(2) located opposite the longitudinal slot 309(4) but closer to the proximal (right) end of the device.

[0129] To complete the steering mechanism for the steering wire 16(i), only one additional tube needs to be added around the outer tube 203. The configuration having the first rings 321 and 323 is the same as that shown in Figures 18A and 18B, which are fabricated from this additional tube. The embodiments in Figures 20A and 20B include a second ring 323 and a third ring 327 attached to the outer tube 203 at a position proximal to the longitudinal slots 309(2) and 309(4).

[0130] Similar to Figures 18A and 18B, the longitudinal slots 309(1), 309(3) and sliding pins 307(1), 307(3) are located between the first ring 321 and the second ring 323. The longitudinal slots 309(2), 309(4) and sliding pins 307(2), 307(4) are located between the second ring 323 and the third ring 327.

[0131] In Figures 20A and 20B, the configuration of the control tube section 302a(1,3), steering wires 16(1), 16(3), first ring 321, second ring 323, longitudinal slots 309(1), 309(3), sliding pins 307(1), 307(3), and helical slots 303a(1), 303a(3) is the same as in Figures 18A and 18B.

[0132] As shown in Figure 20B, the additional tube includes a further control tube section 302a(2,4) which includes a helical slot 303a(4) and a sliding pin 305a(4) within the helical slot 303a(4). The further control tube section 302a(2,4) also has a helical slot 303a(2) and a sliding pin 305a(2) (not visible) provided in the helical slot 303a(2). The helical slots 303a(2) and 303a(4) spiral in opposite directions. Furthermore, the control tube section 302a(2,4) can rotate around the outer tube 203 between the second ring 323 and the third ring 327, but cannot move longitudinally between the second ring 323 and the third ring 327, apart from some possible play due to the manufacturing process. Sliding pins 305a(2) and 305a(4) are attached to sliding pins 307(2) and 307(4) in the outer tube 203, respectively, and sliding pins 305a(2) and 305a(4) are also attached to steering wires 16(2) and 16(4), respectively. When a further control tube section 302a(2,4) rotates tangentially around the coaxially arranged device, the helical slots 303a(2) and 303a(4) actuate both sliding pins 307(2) and 305a(2) and 307(4) and 305a(4), respectively, longitudinally but in opposite directions, the principle of which is explained with reference to Figure 19.

[0133] In this way, a simple, compact, and easily manufactured solution is created for attaching individual steering wire pairs to a simple coupling element that can be directly rotated by, for example, an electrically actuated motor in a robotic arm. The two control tube sections 302a(1,3) and 302a(2,4) can be individually rotated tangentially to steer the instrument tip in any direction. This mechanism does not need to be manufactured as separate parts requiring individual assembly, but here it can be laser-cut integrally and pre-assembled into several tubes, for example, as described in International Publication No. 2016089202. A method for establishing the connection between the further rotatable control tube sections 302a(2,4) and such motors or rotary actuating elements in a handheld handle will be described later in this specification.

[0134] Furthermore, the number of actuators required is reduced compared to the embodiments described in Figures 10 to 14. While steering the instrument tip in any direction required four individual mechanisms in the embodiments shown in Figures 10 to 14, this can be achieved with only two rotary actuators.

[0135] However, it may sometimes be practical to use translational means instead of rotational means to actuate tip steering. For example, in a handheld handle, one can imagine attempting to steer the tip using a sliding knob. In that case, it would be beneficial to incorporate a sliding tube instead of a rotating tube to establish tip steering. Figure 21 schematically shows a steering unit in which two steering wires are actuated in response to the longitudinal sliding of one element.

[0136] In Figure 21, the same reference numerals used in Figure 17 refer to the same components. The schematic configuration of the principle in Figure 21 includes a longitudinal sliding member 331 that can move longitudinally back and forth as indicated by arrow F6. The longitudinal sliding member 331 includes a slit-shaped opening 335, and the sliding members 302(1,3) are provided with pins 333 that are housed within the slit-shaped opening 335. The slit-shaped opening 335 is positioned at an angle ε with respect to the longitudinal direction of the steering wire 16(1) such that 0 < ε < 90 degrees. As the sliding member 331 moves longitudinally back and forth, the sliding member 301 is moved upward / downward as indicated by arrow F1, and the steering wires 16(1), 16(3) are moved longitudinally back and forth in the direction of the longitudinal axis of the device as indicated by arrows F2, F3.

[0137] Similar to Figure 17, the steering wires 16(1) and 16(3) move along the same length in opposite directions, with one generating a tensile force and the other a compressive force, thus causing their ends to bend. The two steering wires 16(1) and 16(3) are acted simultaneously.

[0138] Figures 22A and 22B show one embodiment in which the principle of Figure 21 is implemented. The steering unit configuration in Figures 18A and 18B includes the entire apparatus of Figures 20A and 20B, as shown in Figure 22A. In addition to the components shown in Figures 18A and 18B, the apparatus includes a longitudinal slider 331a configured to actuate the rotation of the control tube section 302a(1,3) by longitudinal movement F6. In Figures 22A and 22B, all components with reference numbers having the subscript "a" have the same function as the components with the same reference numbers without the subscript "a" in Figure 21.

[0139] To this end, in the illustrated example, the longitudinal slider 331a is provided with a longitudinal extension 343 that extends into the longitudinal slot 339 of the fourth ring 337. The width of the slot 339 is matched with the width of the longitudinal extension 343 so that the longitudinal extension 343 can move only in the longitudinal direction of the slot 339 and not in the tangential direction. Furthermore, the fourth ring 337 is mounted so as not to rotate relative to the outer tube 203. To this end, it can be mounted, for example, directly to the outer tube 203 or to the first ring 321 attached to the outer tube 203 by (laser) welding. As those skilled in the art will understand, there are many other possible mechanisms to prevent the longitudinal slider 331a from rotating relative to the outer tube 203.

[0140] In one embodiment, the fourth ring 337 may have an inner diameter that matches the outer diameter of the outer tube 203 and allows it to be directly attached to the outer tube 203. Alternatively, the fourth ring 337 may have an inner diameter that matches the outer diameter of the first ring 321 so that it can be attached to the first ring 321. In this latter example, the fourth ring 337 and the longitudinal slider 331a may be fabricated from an additional tube by providing a suitable material removal pattern for further additional tubes. This additional tube is coaxial with the additional tube from which components 321, 302a(1,3), 305a(1), 305a(3), 303a(1), 303a(3), and 323 are fabricated and is aligned longitudinally.

[0141] The longitudinal slider 331a comprises a helical slot 335a and a sliding pin 333a located inside the helical slot 335a. The sliding pin 333a is attached to the control tube section 302a(1,3). Therefore, the sliding pin 333a cannot move longitudinally and can only move tangentially. During use, the sliding pin 333a is rotated tangentially by moving the longitudinal slider 331a in the longitudinal direction F6. This rotates the control tube section 302a(1,3) tangentially, and as a result, the flexible tip is bent by the opposite longitudinal movement of the steering wires 16(1), 16(3).

[0142] In this way, typically more complex mechanisms, which are made from individually manufactured and assembled parts, can be converted back into easy and inexpensive pre-assembled mechanisms by simply adding one extra tube. That is, pin 333a can be made from tube 331a / 343 by (laser) cutting or any other material removal technique. In a further embodiment, instead of two rotary actuators, two mechanisms as shown in Figures 22A and 22B can be incorporated into the apparatus so that tip deflection in all directions can be established by two linear actuators. For this purpose, a configuration similar to or identical to that shown in Figure 22B, having components 337, 339, 343, 331a, 333a and 335a, can be applied to an apparatus as shown in Figure 20B, such a configuration is configured to control the rotation of control tube section 302a(2,4) by an additional longitudinal slider such as longitudinal slider 331a.

[0143] The number of steering actuators required can be further reduced. For example, if you want to apply a handheld handle with only one steering input to completely control the direction and magnitude of tip steering, and if you want to achieve this with only the movement of one finger instead of the less controllable and less precise movements of the arm and wrist, then you can consider the following:

[0144] Figure 23 schematically shows a steering unit that includes a steering input mechanism capable of controlling two sets of steering wires for steering the tip of the device in any direction.

[0145] To that end, the setup in Figure 23 includes all the features of Figure 21. In addition, the setup includes steering wires 16(2) and 16(4) and a sliding member 302(2,4) configured to control the longitudinal movement of steering wires 16(2) and 16(4). Assume that steering wire 16(2) is positioned 180 degrees tangentially to steering wire 16(4). The four steering wires 16(1), 16(2), 16(3), and 16(4) are positioned at equal distances from each other. The sliding member 302(2,4) includes a slit-shaped opening 303(2) for steering wire 16(2) and a slit-shaped opening 303(4) for steering wire 16(4). Pins 305(2) and 305(4) are attached to steering wires 16(2) and 16(4), respectively, and housed in slit-shaped openings 303(2) and 303(4), respectively. The slit-shaped openings 303(2) and 302(4) are positioned at angles η and φ with respect to the longitudinal direction, respectively. In most practical cases, η = φ. Here, when the sliding member 302(2,4) is moved up / down as indicated by arrow F7, the steering wires 16(2) and 16(4) move in opposite longitudinal directions as indicated by arrows F4 and F5. When η = φ, the steering wires 16(2) and 16(4) will move along the same length in opposite directions such that one generates a tensile force and the other generates a compressive force, thus bending their ends. The two steering wires 16(2) and 16(4) are actuated simultaneously.

[0146] The setup in Figure 23 also includes a sliding member 349 having a longitudinal slot 351 for housing a pin 353 attached to the sliding member 302(2,4). The sliding member 349 can move longitudinally in direction F9 without moving the sliding member 302(2,4) longitudinally. However, when the sliding member 349 moves in direction F8 perpendicular to longitudinal direction F9, the sliding member 302(2,4) is moved in direction F7 by the pin 353 in the slot 351.

[0147] Furthermore, the longitudinal sliding member 331 extends in direction F8 and is provided with a slot 355 for receiving a pin 357 attached to the sliding member 349. Therefore, when the sliding member 349 moves in the longitudinal direction F9, the longitudinal sliding member 331 also moves in its longitudinal direction F7.

[0148] Therefore, the sliding member 349 can move in all directions within the plane of Figure 23, thereby controlling the longitudinal movement of all four steering wires 16(i). The amount of up / down movement F9 determines the amount of opposite longitudinal movement of steering wires 16(2) and 16(4), and the amount of longitudinal forward / backward movement F8 determines the amount of opposite longitudinal movement of steering wires 16(1) and 16(3). Thus, both the amount and direction of deflection in 3D space are controlled by a single component, namely the sliding member 349.

[0149] Figure 24 shows the exterior of one embodiment of a steering unit in which the mechanism of Figure 23 is implemented in coaxially arranged tubes. All components with reference numbers accompanied by the subscript "a" have the same function as the components with the same reference numbers without the subscript "a" in Figure 23. Note that the steering mechanism for steering wires 16(1) and 16(3) is implemented proximal to the steering mechanism for steering wires 16(2) and 16(4).

[0150] At its proximal end, the device is provided with the same functional mechanism as shown in Figures 20A and 20B, in which two control tube sections 302a(1,3) and 302a(2,4) are mounted in reverse longitudinal order. A longitudinal slider 331a, identical to that in Figure 22B, is mounted on the upper part of the control tube section 302a(1,3). The helical slot 335a is helical in the opposite direction here, but this is not technically important. The longitudinal slider 331a is again configured so that it cannot rotate relative to the rings 321 and 323 below, by a mechanism including a longitudinal extension 343 in a longitudinal slot 339 in a fourth ring 337, as seen in Figure 22B, although not shown in Figure 24. However, as in Figures 22A and 22B, the longitudinal slider 331a can slide longitudinally as shown by F6 in order to rotate the control tube portion 302a(1,3) and operate the steering wires 16(1) and 16(3) as described above.

[0151] Furthermore, the longitudinal slider 331a is provided with a tangential slot 355a for accommodating the pin 357a.

[0152] Proximal to the longitudinal slider 331a, the apparatus includes slider 349a. Under the tube, the apparatus includes a rotatable operating mechanism for steering wires 16(2), 16(4), as shown at the proximal end in Figure 20B. In this embodiment, slider 349a is provided with a longitudinal slot 351a for housing a sliding pin 353a. The sliding pin 353a is mounted on the rotatable control tube section 302a(2,4). The longitudinal sliders 331a and 349a may be fabricated, for example, by (laser) cutting to provide a single tube with a suitable material removal pattern. Alternatively, however, they may be fabricated from different tubes.

[0153] A drive element such as tube 359 (not shown in Figure 24, but shown in Figures 25A and 25B) is provided on the top of both the longitudinal slider 331a and the slider 349a. At its distal end, the drive tube 359 is attached to the slider 349a, and at its proximal end, the drive tube 359 is attached to the pin 357a. As a result, simply rotating the drive tube 359 rotates the control tube section 302a(2,4) and acts the steering wires 16(2) and 16(4) of the first steering plane. In this case, the longitudinal slider 331a is not actuated because the pin 357a can move freely tangentially within the tangential slot 355a and does not initiate longitudinal translation of the longitudinal slider 331a. However, as explained with reference to Figures 22A and 22B, when the drive tube 359 is translated only in the longitudinal direction, the longitudinal slider 331a also moves longitudinally, and the rotatable control tube section 302a(1,3) is rotated by the pin 333a in the helical slot 335a. This acts on the steering wires 16(1), 16(3) for the second steering plane. In this case, the rotatable control tube section 302a(2,4) is not actuated because the sliding pin 353a can move freely longitudinally within the longitudinal slot 351a. When the drive tube 359 is rotated and translated, both steering planes are actuated. In this way, one control mechanism (drive element or tube 359) can control two steering planes. This embodiment also requires only the addition of one extra tube with a number of pre-assembled parts, and does not significantly increase the required manufacturing effort or the volume (bulk) of the instrument body.

[0154] Many alternative embodiments are observed to be possible. For example, the functions of the sliding pin 353a and the slider 349a can be reversed. That is, the slider 349a can be mounted on the rotatable control tube section 302a(2,4) instead of the drive tube 359, in which case the sliding pin 353a is mounted on the drive tube 359 rather than the rotatable control tube section 302a(2,4). This is a more compact configuration because the slider 349a is configured only for rotation and does not require space for longitudinal movement.

[0155] Furthermore, the slider 349a and the longitudinal slider 331a may be implemented in reverse longitudinal order such that the slider 349a is located proximal to the longitudinal slider 331a.

[0156] This embodiment is particularly useful when one desires a simple handheld handle with precise means for controlling the steering of the tip in all directions, for example, in a manner similar to using a mousepad by using only one finger.

[0157] Figures 25A and 25B show schematic diagrams of a permanently mounted handle 363. Figure 25A shows a very schematic cross-sectional view of the handle 363 and the proximal end of the steering device. This shows a drive tube 359 surrounding all other steering tubes (not shown again in Figure 25A), which is attached to the slider 349a and pin 357a shown in Figure 24. An additional operating tube 358 can be applied surrounding and attached to the drive tube 359, which can be made of a suitable material such as plastic with a rough surface, for example, so that the operating tube 358 can be easily shifted and / or rotated. Thus, the operating tube 358 can be moved longitudinally and / or circumferentially by, for example, the thumb, as shown in Figure 25B. In this way, the tip of the steering device can be bent in any direction and by any amount, as desired, with only one thumb or the other fingers. An additional cover 361 having an opening 360 that allows the user to operate the control tube 358 with their fingers may be applied to the top of the control tube 358.

[0158] Figure 26 shows a handle 363 similar to that shown in Figure 25A, but here it has a simple coupling mechanism that allows the operating tube 358 and cover 361 to be removed from the steering device, allowing for multiple uses of the handle and a single use of the steering device. As shown, coupling and detachment can be established, in one example, by a locking pin 365 configured to lock the operating tube 358 to the drive tube 359 and a locking pin 367 configured to lock the cover 361 to the outer tube 203. Such locking pins can be pulled back to release the lock. When locked, the locking pin 365 allows the operating tube 358 to move only in all directions together with the drive tube 359, and the locking pin 367 locks the cover 361 to the outer tube 203 in all directions. Obviously, all other well-known removable locking mechanisms such as bayonet locks, locking balls, levers or other mechanisms can be used instead of locking pins. It is easy to see that this configuration has many advantages compared to currently available solutions. The instrument part includes all the complexity required to translate the input of one finger into complete control of the instrument tip, yet it is relatively inexpensive to manufacture and very compact. Furthermore, the instrument can be made from a single material, which is very advantageous for improving waste management. The reusable handle contains minimal mechanical parts, can be potentially easily cleaned and re-sterilized, and is also relatively inexpensive to manufacture.

[0159] Figure 27 shows a simplified form of the steering unit shown in Figure 23. The same reference numerals refer to the same components as in Figure 23. Instead of sliding members 331 and 349, the setup in Figure 27 includes one sliding member 371 that can move in opposite longitudinal directions F6a, F6b and in opposite directions F8a, F8b perpendicular to the longitudinal directions F6a, F6b. The sliding member 371 includes a slot 335 for accommodating a pin 333 and a further slot 369 for accommodating a pin 353. In one embodiment, the further slot is positioned in a direction that is the same as the longitudinal direction but at an opposite angle. In fact, except for components 371, 333, 335, 353 and 369, the setup in Figure 27 is the same as the setup in Figure 19.

[0160] As those skilled in the art will understand, independent control of the longitudinal movement of the steering wires 16(1) / 16(3) and 16(2), 16(4) is also possible in the mechanism of Figure 27 by appropriate movement of the sliding member 371. For example, by moving the sliding member 371 in a linear direction coinciding with a further slot 369, only steering wires 16(1), 16(3) are operated, and by moving the sliding member 371 in a linear direction coinciding with slot 335, only steering wires 16(2), 16(4) are operated. Other movements control the longitudinal movement of all four steering wires.

[0161] Figures 28A to 28D show one embodiment in which the mechanism of Figure 27 is implemented by multiple tubes. Figure 28A shows a tube assembly including the tubes required for the steering wire 16(i), and the attached pins and guide slots. In Figure 28A, rings 321, 323, and 327 are identical to those shown in Figure 20A, even if they are not shown in Figure 28A. The same reference numerals refer to the same components. Figure 28B shows a rotating tube with slots that control the displacement of the steering element when these tubes are rotated. That is, Figure 28B is identical to Figure 22B, and the same reference numerals refer to the same components.

[0162] Figure 28C shows the first tube section 373 and the second tube section 375. The first tube section 373 is positioned on part of rings 321 and 323 and on the rotatable control tube section 302a(1,3). Furthermore, the first tube section 373 is attached to the rotatable control tube section 302a(1,3) but can rotate freely around rings 321 and 323. Therefore, rotating the first tube section 373 causes the steering wires 16(1) and 16(3) to move in opposite longitudinal directions. The second tube section 375 is positioned on part of rings 323 and 327 and on the rotatable control tube section 302a(2,4). Furthermore, the second tube section 375 is attached to the rotatable control tube section 302a(2,4) but can rotate freely around rings 323 and 327. Therefore, rotating the second pipe section 375 causes the steering wires 16(2) and 16(4) to move in opposite longitudinal directions.

[0163] Figure 28D shows a single drive tube 376 with a first helical slot 377 and a second helical slot 379. The first and second helical slots 377 and 379 are helical in opposite directions. A pin 381 inside the second helical slot 379 is shown, which is attached to the second tube section 375. Inside the helical slot 377 is another pin (not visible in Figure 28D) attached to the first tube section 373. It is understood that the first tube section 373 and the second tube section 375 are optional. Next, the pin 381 is directly attached to the rotatable control tube section 302a(2,4), and the pin in the first helical slot 377 is directly attached to the rotatable control tube section 302a(1,3). The pin 381 can be fabricated, for example, from the same tube as the drive tube 376 by (laser) cutting.

[0164] The helical slots 377 and 379 push the pin 381 in the rotational direction, depending on the longitudinal and rotational movement of the drive tube 376. Each rotational and longitudinal position of the drive tube 376 pushes the pin 381 into predetermined discrete positions associated with a unique deflection position of the tip in 3D space. Appropriate software and control motors can easily control the movement of the drive tube 376 so that the desired tip steering is established. This mechanism is also available for the manual control version. When only the drive tube 376 is translated, the two steering planes are actuated simultaneously by the same amount. Intuitively, one might expect that shifting the drive tube 376 longitudinally would cause the tip to move up and down in the vertical plane. However, because the two steering planes are actuated simultaneously, the tip moves by the same amount in the vertical plane as well as the horizontal plane. The tip steering direction for this has an angular deviation of 45 degrees from the vertical plane. To solve this, the instrument shaft can be connected offset by 45 degrees relative to the handle. This results in tip steering in a plane corresponding to what is expected. Pushing the drive tube 376 forward and pulling it backward produces vertical movement in the vertical plane. Rotating the drive tube 376 would now result in tip movement in the horizontal plane.

[0165] All embodiments described above illustrate mechanisms based on the assumption that a rotating or sliding coaxially arranged pipe segment is a preferred method for enabling coupling to a robot or handheld handle that can be established in the field by the end user. From the viewpoint of manufacturing the device integrally with a minimum of separate parts and minimal assembly effort, the methods proposed in International Publication Nos. 2009112060, 2009127236, 2017213491 and 2018067004 can also be used to create other interface types.

[0166] For example, Figures 29A, 29B, and 29C show a mechanism that can be easily fabricated integrally from the tube wall and pre-assembled. Figure 29A shows a gear mechanism, and Figure 29B shows a magnified portion thereof. Figure 29A shows part of an instrument having an intermediate tube 3 with steering wires 16(i) and 16(i) visible. The outer tube 203 is shown having a first longitudinal slot 413 in which a first sawtooth slider 403(2) having teeth 406 is located, and a second longitudinal slot 415 in which a second sawtooth slider 403(1) having teeth 408 is located. The first sawtooth slider 403(2) is attached to the steering wire 16(2), for example, by (laser) welding a portion 409 of the first sawtooth slider 403(2) material. The second sawtooth slider 403(1) is attached to the steering wire 16(1) by, for example, (laser) welding a portion 418 of the material of the second sawtooth slider 403(1). Between the first sawtooth slider 403(2) and the second sawtooth slider 403(1), the outer tube 203 has a strip-like portion 419 that functions as a spacer between the first sawtooth slider 403(2) and the second sawtooth slider 403(1). The strip-like portion 419 has a through hole 417 that houses a gear 401 having teeth 417. The gear 401 has a recess 404 in its center.

[0167] Figures 29A and 29B show several crushing elements 407 used during the manufacturing process, as described in detail, for example, in International Publication No. 2016089202.

[0168] As shown in Figure 29C, in this embodiment, the apparatus has a cover tube 410 outside the outer tube 203. The cover tube 410 has an opening 411 aligned with the opening 404 of the gear 401.

[0169] In this embodiment, the steering wires 16(1) and 16(2) can be moved in opposite longitudinal directions by rotating the gear 401. The rotation of the gear 401 can be established by an actuator in which a suitable shaft is inserted into a recess 404 through an opening 411. An advantage of such a mechanism is that, compared to the embodiments shown in Figures 15 to 28D, this configuration does not require an additional tubing layer to form a complete mechanism that operates on rotational input. Here, the steering wires 16(1) and 16(2) are shown adjacent to each other, but it should be noted that between the gear 401 and the steering wires 16(1) and 16(2), they may be positioned rotated tangentially 180 degrees by having a suitable further transmission system mounted on the same tubing in which the steering wires 16(1) and 16(2) are fabricated.

[0170] The steering wires 16(1), 16(2) can be replaced with longitudinal control elements configured to perform functions of the instrument, such as locking / unlocking a bent instrument component or operating one or more tools at the distal end.

[0171] Another method using the mechanisms shown in Figures 29A to 29C offers even more advantages. Embodiments shown in Figures 15 to 28D describe a mechanism that can be used to actuate only two opposing movable steering wires that can steer the tip of the instrument in a single plane. The actuating of two planes independent of each other allows the tip of the instrument to be steered in any direction by controlling four steering wires.

[0172] However, using only four steering wires limits the force that can be obtained to steer the tip, and therefore limits the amount of force that the tip can exert on the surrounding tissue. These obtainable forces depend on the strength of the steering wires. The dimensions cannot be increased, and therefore the strength of the steering wires cannot be increased indefinitely. As the dimensions increase, the stiffness also increases. With relatively thick steering wires, if the tip is curved more sharply than what the pure elastic deformation of the steering wires allows, the steering wires may deform plastically instead of only elastically. Plastic deformation can shorten the fatigue life of the steering wires to an unacceptable level. Therefore, in some cases, it is desirable to use five or more steering wires per steerable section to obtain composite steering wire strength without compromising bending stiffness and deformation characteristics (fatigue life). The major drawback is as follows: For example, if you want to use eight steering wires and want to steer the tip of the instrument in a particular direction, then typically four steering wires must be pulled and four steering wires must be pushed simultaneously, each over a different displacement. Naturally, the number of mechanisms shown in Figures 15 to 28D can be increased to match the required number of steering wires, but in that case, the number of actuators must also be increased. Controlling the increased number of actuators is practically impossible by manual control, and dealing with, for example, software and electric motors becomes more complex.

[0173] The mechanisms in Figures 29A, 29B, and 29C provide solutions for cases where they are used in a slightly different manner. Figures 30A and 30B show a mechanism in which a gear 401 can rotate around an axis 423(1,2) which is mounted on a lower longitudinal control element 421(1,2) located in an intermediate layer 3 where the steering wire 16(i) is also located, and is inserted into a recess 404 of the gear 401. The axis 423(1,2) can be fabricated from the outer tube 203, for example, by cutting off the central circular portion of the gear 401 and attaching that circular portion to the longitudinal control element 421(1,2). The gear 401 is positioned within a longitudinal slot 402.

[0174] The longitudinal control element 421(1,2) can slide longitudinally parallel to the axis 229 of the instrument. When the longitudinal control element 421(1,2) is translated, the axis 423(1,2) having the gear 401 also moves longitudinally within the longitudinal slot 402, pulling or pushing the two engaged steering wires 16(1), 16(2) in the same longitudinal direction. However, as in the differential gear of a car, the gear 401 rotates freely, so the steering wires 16(1), 16(2) can be displaced over different distances. For example, potentially different displacements of the steering wires 16(1), 16(2), caused by one or more bent portions of the instrument body to be inserted into a curved channel, are such that a balance of pushing or pulling forces is reached. Thus, precise displacements of the two steering wires are obtained automatically, while the combined steering force is evenly divided between the two wires.

[0175] As explained with reference to Figures 15 to 28D, the mechanism in which each controls one steering plane with two steering wires 16(i), 16(i+1) can also be used to control the longitudinal movement of multiple longitudinal control elements 421(i, i+1) that directly hold multiple gears 401 instead of steering wires. Each of these longitudinal control elements 421(i, (i+1)) then controls the longitudinal movement of the two steering wires 16(i), 16(i+1) and compensates for the difference in their respective path lengths. In this way, the tip can be steered in any direction using eight steering wires instead of, for example, four. The steering wires can be arranged such that the combined strength of the eight wires is much higher than the combined strength of four wires with the same flexibility and fatigue life. This setup is shown in Figure 31.

[0176] Figure 31 shows the same steering configuration as in Figure 17. Therefore, it can be implemented using components (laser) cut into multiple coaxial tubes in the manner shown in Figures 18A and 18B. The steering configuration is shown for steering four longitudinal control elements 421(1,2), 421(3,4), 421(5,6), and 421(7,8) in a steerable instrument having eight steering wires 16(1) to 16(8) arranged equidistant around the instrument. Thus, all steering wires 16(i) are positioned rotated 180 degrees tangentially with respect to steering wire 16(i+4). The illustrated steering configuration steers the longitudinal movement of the first longitudinal control element 421(1,2) and the second longitudinal control element 421(5,6). The first longitudinal control element 421(1,2) controls the longitudinal movement of steering wires 16(1) and 16(2) via sawtooth sliders 403(1) and 403(2) and gears 401(5,6), as described with reference to Figures 30A and 30B. The second longitudinal control element 421(5,6) similarly controls the longitudinal movement of steering wires 16(5) and 16(6) via gears 401(5,6) and sawtooth sliders 403(5) and 403(6).

[0177] Figure 31 also shows a single sliding member 302(1,2,5,6) having a slit-shaped opening 303(1,2) for the longitudinal control element 421(1,2). Pins 305(1,2) are attached to the longitudinal control element 421(1,2) and housed in the slit-shaped opening 303(1,2). The slit-shaped opening 303(1,2) is positioned at an angle β with respect to the longitudinal axis. The sliding member 302(1,2,5,6) also has a slit-shaped opening 303(5,6) for the longitudinal control element 421(5,6). Pins 305(5,6) are attached to the longitudinal control element 421(5,6) and housed in the slit-shaped opening 303(5,6). The slit-shaped opening 303(5,6) is positioned at an angle α with respect to the longitudinal axis. In practical terms, α=β in almost all cases. Here, when the sliding member 302(1,2,5,6) is moved downward as indicated by arrow F1, steering wire 16(5,6) moves to the right as indicated by arrow F2, and steering wires 16(1) and 16(2) move to the left as indicated by arrow F3. When α=β, steering wires 16(1) and 16(5) move in opposite directions along the same length such that one generates a tensile force and the other generates a compressive force. The same applies to steering wires 16(2) and 16(6). The four steering wires 16(1), 16(2), 16(5), and 16(6) are actuated simultaneously, and their ends are deflected. As explained with reference to Figures 30A and 30B, the difference in path length between adjacent steering wires 16(1) and 16(2) and between adjacent steering wires 16(5) and 16(6) is compensated. In this way, steering strength can be increased without adversely affecting the flexibility or deformation characteristics of the steering wire.

[0178] In the setups of Figures 30A, 30B, and 31, it is observed that the longitudinal control element 421(i,i+1) is cut from the same intermediate tube as the steering wires 16(i), 16(i+1), and the serrated sliders 403(i), 403(i+1) are cut from the outer tube 203. However, in alternative configurations, the longitudinal control element 421(i,i+1) is cut from the inner or outer tube of its intermediate tube, and the steering wires 16(i), 16(i+1) are serrated themselves. Then, the gear 401 is also located within the intermediate tube and, if applicable, cut from the intermediate tube. Next, the distal longitudinal elements in Figure 31 are the steering wires 16(1), 16(2), 16(5), 16(6), and the gears 401(1,2), 401(5,6) drive them directly.

[0179] The configuration in Figure 31 can be implemented twice to control the longitudinal movement of all eight steering wires 16(1) to 16(8). In that sense, all setups in Figures 19 to 28D can be used so that the steering unit drives longitudinal control elements 421(i,i+1) instead of steering wires 16(1) to 16(8), and each of the longitudinal control elements 421(i,i+1) controls the longitudinal movement of two adjacent steering wires 16(i), 16(i+1). Furthermore, the embodiment in Figure 31 is not limited to eight steering wires 16(1) to 16(8), but can be used for 8*S steering wires, where S = 1, 2, 3, ...

[0180] It has also been observed that the setups in Figures 30A, 30B, and 31 can be used to control the longitudinal movement of one or more longitudinal control elements 421 having other functions of the instrument, such as locking / unlocking the bent portion of the instrument in use or operating one or more tools at the distal end of the instrument.

[0181] Figures 32A, 32B, 32C, and 32D illustrate another method of using gears to actuate the steering wire. Here, the same reference numerals used in Figures 29A, 29B, and 29B refer to the same components. In this embodiment, the serrated sliders 403(1) and 403(2) are operated by a geared pinion 425. Figure 32D shows the gear 427 of the geared pinion 425 in contact with the teeth 406 and 408 of the serrated sliders 403(1) and 403(2).

[0182] In an alternative embodiment, sliders 403(1) and 403(2) are not applied, but the steering wires 16(1) and 16(2) themselves are provided with sawtooth-shaped sides similar to those of the sawtooth-shaped sliders 403(1) and 403(2). In such an embodiment, the gear 427 of the geared pinion 425 directly contacts these sawtooth-shaped sides to drive the steering wires 16(1) and 16(2).

[0183] Figure 32C shows that the cover tube 410 can be applied to the top of the outer tube 203 if the cover tube 410 has a suitable opening for the geared pinion 425 to pass through. Note that if the steering wires 16(1) and 16(2) themselves are serrated, it is not necessary to apply the cover tube 410.

[0184] Figure 33 shows an alternative configuration of Figures 22A and 22B. Specifically, Figure 33 schematically illustrates how longitudinal movement can be converted to rotational motion and vice versa by using gears. Figure 33 shows a longitudinal sawtooth element 429 and a rotatable sawtooth element 431, both of which contact the same gear 433. The rotational motion of the rotatable sawtooth element 431 causes longitudinal movement of the longitudinal sawtooth element 429 via the gear 433, and vice versa. The longitudinal sawtooth element 429 may be implemented as part of a longitudinal slider, such as the longitudinal extension 343 of the longitudinal slider 331a in Figure 22A. The rotatable sawtooth element 431 may be the control tube portion 302a(1,3) in Figure 22A. This mechanism can also be used as an alternative to Figures 16A and 16B. The longitudinal sawtooth element 429 may be a steering wire 16(i), in which case the steering wire 16(i) may be driven by the rotation of a rotatable sawtooth element 431.

[0185] In a further embodiment, the setup shown in Figure 33 can be used to drive two opposing steering wires 16(1) and 16(3). This setup then includes two gears 433 configured to drive the opposing steering wires 16(1) and 16(3), respectively, which are then driven by a rotatable element 431, which rotates the rotatable element 431, thereby resulting in opposing longitudinal movement of the two opposing steering wires 16(1) and 16(3).

[0186] Furthermore, the configuration shown in Figure 33, in which another sawtooth-shaped rotatable element drives the steering wires 16(2) and 16(4), can be replaced with a setup using control tube section 302(2,4), which is also made sawtooth-shaped via gears.

[0187] Figure 34 illustrates that gears can be used to drive an output element at a different speed or magnitude of displacement compared to an input element. For example, the configuration shown in Figure 34 includes two sawtooth longitudinal elements 429 and 435. Both of their sawtooth sides are in contact with a gear configuration 437 having a first gear 439 with a first number of teeth and a second setting gear 441 with a second number of teeth, where the first number is smaller than the second number, but the reverse is also possible. The first gear 437 is in contact with the sawtooth side of the sawtooth longitudinal element 429, and the gear 441 is in contact with the sawtooth side of the sawtooth longitudinal element 435. Then, the longitudinal movement of the sawtooth longitudinal element 429 is slower than the longitudinal movement of the sawtooth longitudinal element 435, depending on the gear ratio between gears 437 and 441. The sawtooth longitudinal element 429 may be part of a sliding pipe of a device. It is also clear that a gear configuration 437 could be used instead of the gear 433 in the setup of Figure 33 to establish a desired ratio between the rotation of the rotatable sawtooth element 431 and the translation of the longitudinal sawtooth element 429.

[0188] Figure 35 shows a schematic setup of an alternative to Figures 28A-28D. Figure 35 shows a schematic side view of a first rotatable element 443 and a second rotatable element 445 having the same radius in this embodiment. A third rotatable element 447 is positioned coaxially with the first and second rotatable elements 443 and 445. The rotatable element 445 may be located proximal to the rotatable element 443. The rotatable element 445 has teeth 446 on its distal side, and the rotatable element 443 has teeth 444 on its proximal side. A gear 450 is provided between teeth 444 and teeth 446 and is in contact with both teeth. When the gear 450 rotates, the rotatable elements 443 and 445 rotate in opposite directions.

[0189] The gear 450 extends radially within a longitudinal opening 449 of the third rotatable element 447. The longitudinal opening 449 has a serrated longitudinal side surface 448 having teeth that engage with the gear 450. The rotatable element 447 can not only rotate but also move longitudinally.

[0190] This setup can be applied to the setups in Figures 28A to 28D, namely, the first rotatable element 443 may be the control tube section 302a(1,3), and the second rotatable element 445 may be the control tube section 302a(2,4). Furthermore, gears 450 are positioned between them, and they have opposing serrated sides 444, 446. Then, a third rotatable element 447 replaces tubes 373, 375, and 359. In this case, as described with reference to Figures 28A to 28D, the flexible tip section can be bent in any direction in 3D space by manipulating the third rotatable element 447 in its longitudinal and / or tangential direction, for example with a thumb.

[0191] Intuitively, moving the third rotatable element 447 longitudinally back and forth would be expected to cause the tip to move up and down in the vertical plane. However, since the two steering planes are actuated simultaneously, the tip moves by the same magnitude in both the horizontal and vertical planes. Therefore, the tip steering direction has a 45-degree angular deviation from the vertical plane. To resolve this, the instrument shaft can be connected with a 45-degree offset relative to the handle. This results in tip steering in the plane corresponding to what is expected. Pushing the third rotatable element 447 forward and pulling it backward produces up-and-down movement in the vertical plane. Rotating the third rotatable element 447 produces movement of the tip in the horizontal plane.

[0192] Figures 29 to 35 show some examples of how mechanisms with slotted elements having corresponding slider pins can be replaced with gear elements. In practice, all slot and pin mechanisms can be replaced with gears, and vice versa.

[0193] Clearly, any number of mechanisms, as presented in all the embodiments above, can be applied to actuate any number of steering wires / longitudinal control elements or sets of steering wires / longitudinal control elements or differential drives. For example, if it is desired to control two distally steerable sections, a suitable combination of the embodiments above can be applied to obtain steering for any desired number of steering wires per steerable section, while the number of actuator inputs can still be minimized to one actuating element (rotatable and sliding) per steerable section.

[0194] The above embodiments can be used not only for the operation of steering wires, but also for the operation of longitudinal control elements used, for example, for opening and closing surgical grippers or other tools.

[0195] As already explained, the above embodiments offer significant advantages over currently used solutions. Current solutions for controlling steering wires typically involve many separately manufactured parts, requiring considerable assembly effort. The above embodiments demonstrate pre-assembled, easily manufactured parts, which is almost entirely free, considering that the flexible section and the necessary features for the steering wire must be (laser) cut anyway to create the instrument body. Adding the cutting of the mechanism for the described embodiments into the same tube in the same manufacturing process is not more expensive and requires no more metal. Adding one or two short tubes to complete the described mechanism would add little to the effort or cost.

[0196] Another significant advantage, already described, is that the difficult part of connecting the individual steering wires of the instrument to the rest of the required steering mechanism is already established within the instrument itself, making it easy to establish coupling between the instrument and an external controller, such as a reusable handheld controller or a robot. The number of required control elements within the external controller is also significantly reduced by the mechanism of the instrument itself. Possible couplings that can be easily established by the end user in the field can be easily envisioned.

[0197] For example, when a rotary tube is used as an interface, slots can be easily cut into the tube to engage with the keys or splines of the hand controller or robot receiver used. Figures 36A, 36B, and 36C show an example of coupling two rotary tubes with disposable device 1 that directly engage with the two hollow keyed or splined shafts of two electric actuator motors without adding any other mechanisms or parts within the robot.

[0198] Figure 36A shows the proximal end of an example of a steerable device 1. This shows two control tube sections 302a(1,3) and 302(2,4). However, as previously described, there may be one or more such control tube sections. Above these control tube sections 302a(1,3) and 302a(2,4), there may be an extra tube section to protect the helical slit 303a(i) from the collection of dust and other debris. In the illustrated embodiment, the control tube sections 302a(1,3) and 302a(2,4) are provided with plates 456 and 458, respectively, attached to the outer surfaces of the control tube sections 302a(1,3) and 302a(2,4). Here, the plates 456 and 458 are identical and aligned tangentially.

[0199] Figure 36A shows the first motor 452 and the second motor 454, as well as the first electrical wiring 453 and the second electrical wiring 455 for the first motor 452 and the second motor 454, respectively. These wirings 453 and 455 are configured to carry the drive current and appropriate control signals to the first and second motors 452 and 454. Both the first and second motors 452 and 454 have hollow drive shafts. Figure 36A shows both the electric motors 452 and 454 in a separated state. Figure 36B shows the steering device inserted into the hollow shafts of the first and second motors 452 and 454. In this state, the plate 457 of the control tube section 302a(2,4) is inserted into the slot 460 of the hollow shaft of the second motor 454, and the rotation of this hollow drive shaft causes the control tube section 302a(2,4) to rotate (see Figure 36C). Although not shown, the first motor 452 has a similar slot inside its hollow drive shaft for accommodating the plate 456, such that the rotation of the hollow drive shaft of the first motor 452 causes the rotation of the control tube section 302a(1,3). In this way, the rotation of the control tube sections 302a(1,3), 302a(2,4) can be independently controlled by appropriate software stored in the robot system's processor, for example, to flex the tip of a steerable device in any desired direction in 3D space.

[0200] In the separated state, the slot 460 of the second motor 454 and the similar slot of the first motor 452 are aligned tangentially, as in plates 457 and 456, so that the control tube portion 302a(2,4) can pass through the slot of the first motor 452. In this way, the steering device 1 can be easily coupled to and detached from the first and second motors 452 and 454.

[0201] The embodiments shown in Figures 36A and 36B are merely one example of a method by which control tube sections 302a(1,3) and 302a(2,4) can be detachably coupled to the first and second motors 452 and 454, as will be obvious to those skilled in the art.

[0202] Figures 36A, 36B, and 36C show that the steerable device 1 has a tube section 457 located distal to the control tube sections 302a(1,3) and 302a(2,4) and forming the outermost tube. The tube section 457 is provided with a plate 459. In practice, the first and second motors 452 and 454 are housed in a housing. In this example, such a housing is provided with suitable openings through which the control tube sections 302a(1,3) and 302a(2,4), having plates 456 and 457, can pass toward and away from the first and second motors 452 and 454. Next, the openings of the plate 459 and the housing are configured to lock together in a detachable manner, thereby locking the steerable device 1 to the housing in both rotation and translation, and the control tube sections 302a(1,3) and 302a(2,4) are properly aligned with the first and second motors 452 and 454. The detachable locking can be achieved by any suitable mechanism, such as a click or bayonet mechanism.

[0203] Another method involves providing the teeth 470 of a spur gear or the teeth 472 of a worm drive gear on the rotatable or sliding tubular interface of the device (see Figures 37 and 38). The advantage of this method is that, for example, if it is desired to control two or more steerable sections within the device, the overall length of the coupling can be minimized. If a coaxial hollow shaft with motors attached is used and four or more motors are required to control two or more sections, the overall length of the coupling can be considerably longer. As shown here, the radial arrangement can significantly reduce the length of the coupling, and therefore the overall length of the device.

[0204] Figure 26 already shows an example of coupling between a reusable hand controller and an instrument with a single combined sliding and rotating interface. Naturally, this interface can be coupled to a robot controller using an equivalent method.

[0205] It is clear that instruments having two rotary or sliding interfaces can also be easily coupled to handheld actuators that include only simple additional mechanisms to enable finger control of these interfaces.

[0206] It is acknowledged that the present invention is not limited with respect to the number of tubes. For example, the device may have more tubes than shown in this example. The steering wire 16(i) may have separate parts that are connected or attached to each other, made from the tubular material of two or more such tubes, as described in International Publication No. 2017213491. Furthermore, the device may have other longitudinal control elements made from tubular material and configured to lock or unlock the curvature of a part of the body, as described in International Publication No. 2023287289, for example, to perform a function other than those described above.

[0207] While the invasive instrument is shown to have one flexible tip, the present invention is not limited thereto. That is, the invasive instrument may have multiple flexible tip portions.

[0208] All tubes are made of, at least partially, the following combination of materials: Biocompatible polymer materials including polyurethane, polyethylene, or polypropylene, Stainless steel alloy, Cobalt-chromium alloy, Shape memory alloys such as Nitinol (registered trademark), plastic, polymer, Composite material, or Other curing materials It can be made from at least one of the following.

[0209] In one embodiment, the components of the tube, including one or more steering wires 16(i) and longitudinal control elements, are derived from a material removal technique applied to the tube wall to create a suitable material removal pattern, including at least one of photochemical etching, deep drawing, cutting, laser cutting, or water cutting. The material removal means may be a laser beam or waterjet cutting beam that melts and vaporizes the material, and the beam may have a width of 0.01 to 2.00 mm, more typically 0.015 to 0.04 mm in this application.

[0210] The wall thickness of the tube depends on its application. In applications with maneuverable surgical instruments, the wall thickness may be in the range of 0.03 to 2.0 mm, preferably 0.03 to 1.0 mm, more preferably 0.05 to 0.5 mm, and most preferably 0.08 to 0.4 mm. The diameter of the tube depends on its application. In applications with maneuverable surgical instruments, the diameter may be in the range of 0.5 to 20 mm, preferably 0.5 to 10 mm, and more preferably 0.5 to 6 mm. The radial clearance between adjacent tubes may be in the range of 0.01 to 0.3 mm.

[0211] It is observed that pins 305a(i), 307(i), 333a, 353a, 357a, and 381 may have any desired shape, including but not limited to circular, rectangular, or elliptical shapes.

[0212] The features of the present invention, as described with reference to the drawings above, can be summarized as follows.

[0213] A first embodiment relates to a steering device having at least one flexible tip portion (13, 74, 75) distally, the steering device including a first steering wire (16(1), 429) attached to at least one flexible tip portion (13, 74, 75), the first steering wire (16(1), 429) being part of at least one tube (3, 102, 103, 121), and the other part of at least one tube (3, 102, 103, 121) being removed by a first material removal pattern such that the first steering wire (16(1), 429) extends from the proximal end to the distal end of the steering device Separated from the steering device, the steering device includes a steering unit comprising a first control tube portion (301a(i), 302a(1,3), 431) arranged coaxially with at least one tube (3), wherein the first control tube portion (301a(i), 302a(1,3), 431) and the first steering wire (16(1)) are configured such that rotation of the first control tube portion (301a(i), 302a(1,3), 431) causes longitudinal movement of the first steering wire (16(1), 429) in a first longitudinal direction to flex at least one flexible tip portion (13, 74, 75) in a first plane.

[0214] The first control tube portion (301a(i)) may be provided with a first helical slot (303a(1)), and the first sliding element (305a(1)) attached to the first steering wire (16(1)) is provided in the first helical slot (303a(1)) such that the rotation of the first control tube portion (301a(i)) causes longitudinal movement of the first steering wire (16(1)) in the first longitudinal direction.

[0215] The first control tube portion may be a sawtooth-shaped first control portion (431), and the steering device may be provided with a gear (433) configured to convert the rotation of the first control tube portion (431) into longitudinal movement of the first steering wire (429).

[0216] In the first example, the steerable device may include a second steering wire (16(3), 435) attached to at least one flexible tip portion (13, 74, 75), the second steering wire (16(3), 435) is also part of at least one tube (3), and is separated from the rest of at least one tube (3, 102, 103, 121) by a second material removal pattern such that the second steering wire (16(3), 435) extends from the proximal end to the distal end, and the first control tube portion (302a(1,3), 431) and The second steering wire (16(3), 435) is configured such that the rotation of the first control tube section (302a(1,3)) causes longitudinal movement of the second steering wire (16(3)) in the second longitudinal direction to cause at least one flexible tip section (13, 74, 75) to bend, in the first plane, the second longitudinal direction is opposite to the first longitudinal direction, and the second steering wire (16(3), 435) is optionally positioned 180 degrees tangentially to the first steering wire (16(1)).

[0217] In the first example, the first control tube portion (302a(1,3)) may be provided with a second helical slot (303a(3)), and the second sliding element (305a(3)) attached to the second steering wire (16(3)) is provided in the second helical slot (303a(3)) such that the rotation of the first control tube portion (302a(1,3)) causes longitudinal movement of the second steering wire (16(3)) in the second longitudinal direction.

[0218] In the first example, the first control tube portion may be a serrated first control tube portion (431), and the steering device may be provided with a gear (433) configured to convert the rotation of the serrated first control tube portion (431) into opposite longitudinal movements of the first and second steering wires.

[0219] In the first example, the steering device may include third and fourth steering wires (16(2), 16(4)) attached to at least one flexible tip portion (13, 74, 75), the third and fourth steering wires (16(2), 16(4)) being part of at least one tube (3), and separated from the rest of at least one tube (3, 102, 103, 121) by third and fourth material removal patterns such that the second and fourth steering wires (16(2), 16(4)) extend from the proximal end to the distal end, and the steering unit includes a second control tube portion (3) coaxially positioned with at least one tube (3). The second control tube section (302a(2,4)) and the third and fourth steering wires (16(2), 16(4)) are configured such that rotation of the second control tube section (302(2,4)) causes longitudinal movement of the third and fourth steering wires (16(2), 16(4)) in the opposite longitudinal direction to flex at least one flexible tip section (13, 74, 75) in a second plane perpendicular to the first plane, and the first, second, third and fourth steering wires (16(1), 16(2), 16(3), 16(4)) are optionally positioned equidistant from each other in the tangential direction of the steering device.

[0220] Next, the second control tube section (302(2,4)) may be provided with third and fourth helical slots (303a(2), 303a(4)), such that rotation of the second control tube section (302(2,4)) causes longitudinal movement of the third and fourth steering wires (16(2), 16(4)) in opposite longitudinal directions. A third sliding element (305a(2)) attached to the third steering wire (16(2)) is provided in the third helical slot (303a(2)), and a fourth sliding element (305a(4)) attached to the fourth steering wire (16(4)) is provided in the fourth helical slot (303a(4)).

[0221] Alternatively, the second control tube portion may be a serrated second control tube portion, and the steering device may be provided with gears configured to convert the rotation of the serrated second control tube portion into opposite longitudinal movements of the third and fourth steering wires.

[0222] The steering device may include further tubes (4, 104, 203) coaxially positioned between at least one tube (3, 101, 102, 121) and a first control tube portion (301a(i)), the further tubes being provided with a first longitudinal slot (309(1)), and a first sliding element (305a(1)) being attached to a first steering wire (16(1)) through the first longitudinal slot (309(1)).

[0223] Next, the first sliding element may include a first sliding pin (305a(1)), and the further tube may include a second sliding pin (307(1)) attached to both the first sliding pin (305a(1)) and the first steering wire (16(1)).

[0224] In the first example, the steering device may include a further tube (4, 104, 203) coaxially positioned between at least one tube (3, 101, 102, 121) and a first control tube portion (302a(1,3)), the further tube having a first longitudinal slot (309(1)) and a second longitudinal slot (309(3)), the first sliding element (305a(1)) being attached to a first steering wire (16(1)) through the first longitudinal slot (309(1)), and the second sliding element (305a(3)) being attached to a second steering wire (16(3)) through the second longitudinal slot (309(3)).

[0225] Next, the first sliding element may include a first sliding pin (305a(1)), and a further tube may include a second sliding pin (307(1)) attached to both the first sliding pin (305a(1)) and the first steering wire (16(1)), the second sliding element may include a third sliding pin (305a(3)), and a further tube may include a fourth sliding pin (307(3)) attached to both the third sliding pin (305a(3)) and the second steering wire (16(3)).

[0226] The steering device may include a first component (321) attached to a further tube (203) distal to the first control tube section (301a(i), 302a(1,3)) so as to prevent longitudinal movement of the first control tube section (301a(i), 302a(1,3)), and a second component (323) attached to a further tube (203) proximal to the first control tube section (301a(i), 302a(1,3)).

[0227] The steering device may include a longitudinal slider (331a) having a third helical slot (335a), and a third sliding element (333a) attached to a first control tube section (301a(i), 302a(1,3)) is provided in the third helical slot (335a) such that longitudinal movement of the longitudinal slider (331a) causes rotation of the first control tube section (301a(i), 302a(1,3)).

[0228] The steering device may include further tubes (4, 104, 203) coaxially arranged between at least one tube (3, 101, 102, 121) and the first and second control tube sections (302a(1,3), 302(2,4)), the further tubes having a first longitudinal slot (309(1)), a second longitudinal slot (309(3)), a third longitudinal slot (309(2)), and a fourth longitudinal slot (309(4)), and the first sliding element (305a(1)) having the first longitudinal slot (309( The first steering wire (16(1)) is attached through a second longitudinal slot (309(3)), the second sliding element (305a(3)) is attached through a second longitudinal slot (309(3)), the third sliding element (305a(2)) is attached through a third longitudinal slot (309(2)) to the third steering wire (16(2)), and the fourth sliding element (305a(4)) is attached through a fourth longitudinal slot (309(4)) to the second steering wire (16(3)).

[0229] The first sliding element may include a first sliding pin (305a(1)), and the further tube may include a second sliding pin (307(1)) attached to both the first sliding pin (305a(1)) and the first steering wire (16(1)), the second sliding element may include a third sliding pin (305a(3)), and the further tube may include a fourth sliding pin (307(3)) attached to both the third sliding pin (305a(3)) and the second steering wire (16(3)). The third sliding element includes a fifth sliding pin (305a(2)), and the further tube includes a sixth sliding pin (307(2)) attached to both the fifth sliding pin (305a(2)) and the third steering wire (16(2)). The fourth sliding element includes a seventh sliding pin (305a(4)), and the further tube includes an eighth sliding pin (307(4)) attached to both the seventh sliding pin (305a(4)) and the fourth steering wire (16(4)).

[0230] The steering device may include a first component (321) attached to a further tube (203) distal to the first control tube section (302a(1,3)), a second component (323) attached to a further tube (203) proximal to the first control tube section (302a(1,3)), a third component (323) attached to a further tube (203) distal to the second control tube section (302a(2,4)), and a fourth component (327) attached to a further tube (203) proximal to the second control tube section (302a(2,4)), so as to prevent longitudinal movement of the first and second control tube sections (302a(1,3) and 302a(2,4)).

[0231] The steering device includes a longitudinal slider (331a) connected to a first control tube section (302a(1,3)) such that longitudinal movement of the longitudinal slider (331a) causes rotation of the first control tube section (302a(1,3)), and the steering device includes a slider (349a) connected to a second control tube section (302a(2,4)) such that rotation of the slider (349a) causes rotation of the second control tube section (302a(2, 4)) includes a slider (349a) connected to and includes a connecting component (359) which connects the longitudinal slider (331a) and the slider (349a) such that when the connecting component (359) moves longitudinally, it causes longitudinal movement of the longitudinal slider (331a), and when the connecting component (359) rotates, it causes rotational motion of the slider (349a), the connecting component (359) may have a tubular shape.

[0232] The slider (349a) may be provided with a fifth longitudinal slot (351a) for accommodating a ninth sliding pin (353a), the longitudinal slider (331a) may be provided with a third helical slot (335a) and a tangential slot (355a) for accommodating a tenth sliding pin (357a), and the third sliding element (333a) attached to the first control tube portion (301a(i), 302a(1,3)) is provided in the third helical slot (335a). The connecting component (359) is either attached to both the 10th sliding pin (357a) and the 9th sliding pin (353a) while the slider (349a) is attached to the second control tube section (302a(2,4)), or attached to both the 10th sliding pin (357a) and the slider (349a) while the 9th sliding pin (353a) is attached to the second control tube section (302a(2,4)).

[0233] The steering device includes drive elements (331a, 359, 447) connected to a first control tube section (302a(1,3)) such that longitudinal movement of the drive elements (359, 447) causes rotation of the first control tube section (302a(1,3)) in a first tangential direction, and the drive elements (359, 447) are such that longitudinal movement of the drive elements (359, 447) causes rotation of the first control tube section (302a(1,3)) in a second tangential direction opposite to the first tangential direction. The drive elements (359, 447) are connected to the first and second control tube sections (302a(1,3), 302a(2,4)) such that the tangential rotation of the drive elements (359, 447) causes tangential rotation of both the first and second control tube sections (302a(1,3), 302a(2,4)) in the same direction.

[0234] The drive element (331a) may include a third helical slot (335a), with a third sliding element (333a) attached to the first control tube section (302a(1,3)) provided in the third helical slot (335a), and may also include a fourth helical slot (335a), with a fourth sliding element (333a) attached to the second control tube section (302a(2,4)) provided in the fourth helical slot (335a).

[0235] The drive element may include a tubular drive element (447) having a sawtooth opening for housing a gear (450), configured to rotate the gear (450) when the tubular drive element (447) moves longitudinally, and the gear (450) is configured to rotate its sawtooth first and second control tube portions (443, 445) in opposite tangential directions when it rotates.

[0236] In a second aspect, the present invention relates to a steerable device having at least one flexible tip portion (13, 74, 75) distally, the steerable device includes a first steering wire (16(1), 429) attached to at least one flexible tip portion (13, 74, 75), the first steering wire (16(1), 429) being part of at least one tube (3, 102, 103, 121) and separated from the rest of at least one tube (3, 102, 103, 121) by a first material removal pattern such that the first steering wire (16(1), 429) extends from the proximal end to the distal end of the steerable device, and longitudinal movement of the first steering wire (16(1), 429) is directed toward at least one flexible tip portion in a first plane ( 13, 74, 75) causing deflection, the steering device includes a steering unit including at least one longitudinal control element (421(1,2)) and a first control tube section (301a(i), 302a(1,3), 431) arranged coaxially with at least one tube (3), wherein the first control tube section (301a(i), 302a(1,3), 431) and at least one longitudinal control element (421(1,2)) are configured such that rotation of the first control tube section (301a(i), 302a(1,3)) causes longitudinal movement of at least one longitudinal control element (421(1,2)) to control a function of the steering device, such as locking or unlocking a bent portion of the device or operating a tool at at least one flexible tip portion.

[0237] In this second aspect, the first longitudinal control element (421(1,2)) can be connected to the first control tube portion (302a(1), 302a(1,3)) at its proximal end and can be connected to the first steering wire (16(1)) and the second steering wire (16(2)) via a gear configuration (401(1,2), 401(1,2), 403(1), 403(2)) at its distal end. The first longitudinal control element (421(1,2)) and the gear configuration (401(1,2), 401(1,2), 403(1), 403(2)) are configured such that the longitudinal movement of the first longitudinal control element (421(1,2)) results in the longitudinal movement of both the first and second steering wires (16(1), 16(2)) in the same longitudinal direction. The gear configuration is configured to compensate for the path length difference between the first and second steering wires (16(1), 16(2)).

[0238] The present invention relates to an invasive instrument including a steerable instrument of the first or second aspect.

[0239] The present invention relates to a control unit and a steerable instrument, the control unit including a first motor (452) configured to be removably coupled to the first control tube portion (302a(1,3)).

[0240] The present invention relates to a control unit and a steerable instrument, the control unit including a first motor (452) and a second motor (454), the first motor (452) being configured to be removably coupled to the first control tube portion (302a(1,3)), and the second motor (454) being configured to be removably coupled to the second control tube portion (302a(2,4)).

[0241] In an invasive instrument including a manually operable control unit and a steerable instrument, the manually operable control unit can be configured to enable a user to manually move a connection component (359) in both the longitudinal and tangential directions with a finger.

[0242] In an invasive device including a manually operable control unit and a steerable device, the manually operable control unit may be configured to allow the user to manually move the drive element (359) both longitudinally and tangentially with their fingers.

[0243] A manually operable control unit may be detachably coupled to a steering device.

[0244] Path length compensation The concept of a drive mechanism based on a rotatable bushing can be applied to compensate for undesirable changes in the path length of a steering wire in a multi-flexible invasive instrument. In many applications, it is desirable to be able to control the deflection of multiple flexible regions in a steering (invasive) instrument completely independently. However, in many implementations, the deflection of multiple flexible regions is dependent on each other. This can be illustrated with reference to Figures 7A, 8, and 9, which show an example of an instrument having two flexible regions 152 and 154.

[0245] In Figure 7A, both flexible regions 152 and 154 are not actuated and therefore extend linearly. Figure 8 shows a desired method of bending the flexible region 154, i.e., the flexible region 154 can be bent without affecting the deflection of the flexible region 152. However, if no additional means are taken, bending the flexible region 154 as shown in Figure 8 will cause the flexible region 152 to bend as shown in Figure 9.

[0246] This is caused by the fact that the portion of the steering wire for the flexible region 152 located inside the shorter side of the bent flexible region 154 obtains a shorter path length in the flexible region 154, and the portion of the steering wire for the flexible region 152 located inside the longer side of the bent flexible region 154 obtains a longer path length in the flexible region 154. As a result, the flexible region 152 automatically bends in the opposite direction to the bending direction of the flexible region 154. This is true for both steering wires to which tensile or compressive forces are applied.

[0247] Figures 39A and 39B schematically illustrate an example of independent control of two flexible regions 152 and 154. In this example, both flexible regions 152 and 154 can be deflected in the plane of the figure by appropriately positioned steering wires (not shown). Figure 39A shows that flexible region 154 is deflected without affecting the linear state of flexible region 152. Figure 39B shows that flexible region 152 is deflected without affecting the deflection state of flexible region 154.

[0248] International Publication No. 2022260518, a brochure by the same applicant as this patent document, discloses a mechanism for compensating for path length differences between steering wires caused by the bending of a flexible body of an invasive instrument from which these steering wires extend. Some embodiments of this prior art patent document are implemented by a rotatable bushing configured to extend or shorten the length of one or more steering wires in response to such bending of the flexible body. One or more sensing wires control the rotation of such bushing by longitudinal movement. Each sensing wire is mounted in an internal position of the body and moves longitudinally as the body bends at that position. The inventors of this patent document have found that a similar but simplified mechanism can be used to compensate for undesirable path length variations of steering wires in a particular flexible region caused by bending in another flexible region. Here, no extra sensing wires are applied. Furthermore, the compensation mechanism is integrated into a steering mechanism for one or more steering wires.

[0249] The basic principle can be explained by referring to Figure 40.

[0250] Figure 40 shows a schematic setup of a length compensation section 380 positioned appropriately within the instrument. The example in Figure 40 relates to a steerable instrument having two flexible regions, e.g., regions 152 and 154 in Figures 39A and 39B. Figure 40 illustrates the principle of the present invention in 2D. However, this can be readily implemented in a steerable invasive instrument having a coaxial tube and a pattern fabricated by (laser) cutting patterns or any other material removal techniques, as described below. In such an implementation, the plane in Figure 40 becomes the circular surface of one or more tubes.

[0251] Figure 40 shows steering wires 16(1,1) and 16(2,1), which are guided by the surrounding structure so that they can move only longitudinally and not vertically or perpendicular to the drawing. Steering wire 16(1,1) is configured to steer the flexible region 154, and steering wire 16(2,1) is configured to steer the flexible region 152. They are located on the same side of the fixture so that the change in the path length of one steering wire 16(1,1) and 16(2,1) inside the fixture caused by the deflection of one of the flexible regions 152 and 154 is equal to the change in the path length of the other steering wire 16(1,1) and 16(2,1).

[0252] More specifically, Figure 40 shows a first wall 382 extending laterally perpendicular to the longitudinal direction of the steering wires 16(1,1) and 16(2,1). The steering wire 16(2,1) is shown having a portion 16(2,1) on the left side of the length compensation section 380 and a portion 16e(2,1) on the right side. The length compensation section 380 also includes a second wall 384 extending parallel to the first wall 382 and a first slider 320 that can slide laterally up and down between the walls 382 and 384 as indicated by the double arrow dV. The first slider 320 is provided with an opening 326 that accommodates a second slider 316, thereby allowing the second slider 316 to slide back and forth in a longitudinal direction parallel to the opening 326 as indicated by the double arrow dH.

[0253] Here, the steering wire 16(1,1) extends into the space between the first wall 382 and the second wall 384 through a suitable opening in the first wall 382. The steering wire 16(1,1) may be provided with a projection such as a pin 305(1,1) extending into the inner slot 303(1,1) of the first slider 320. Here, the slot 303(1,1) is linear and extends at an angle of 0 < α1 < 90 degrees with respect to the longitudinal direction. Alternatively, note that α1 may be in the opposite direction, and -90 < α1 < 0.

[0254] The left steering wire portion 16(2,1) also extends into the space between the first wall 382 and the second wall 384 through a suitable opening in the first wall 382. The left steering wire portion 16(2,1) may be provided with a projection such as a pin 312(2,1) extending into the inner slot 308(2,1) of the second slider 316. Here, the slot 308(2,1) is linear and extends at an angle of 0 < α2 < 90 degrees with respect to the lateral direction. Alternatively, note that α2 may be in the opposite direction, and -90 < α2 < 0.

[0255] The right steering wire portion 16e(2,1) also extends into the space between the first wall 382 and the second wall 384 through a suitable opening in the second wall 384, so that the left and right steering wire portions 16(2,1) and 16e(2,1) extend in opposite directions from the length compensation section 380. The right steering wire portion 16e(2,1) may be provided with a projection such as a pin 314(2,1) extending into the inner slot 310(2,1) of the second slider 316, where the slot 310(2,1) is linear and extends transversely perpendicular to the longitudinal direction.

[0256] All projections 305(1,1), 312(2,1), and 314(2,1) can be implemented as fixed projections molded into, for example, a circular or corresponding slot geometric shape. However, they may have any other suitable cross-section.

[0257] The flexible region 154 can be made flexible by moving the slider 320 upward or downward, which causes the steering wire 16(1,1) to move longitudinally.

[0258] For example, when slider 320 is moved upward, steering wire 16(1,1) moves to the right within length compensation section 380. In this case, steering wire 16(1,1) is located in the inner curve of the deflection region 154, and its path length within the left-side fixture of length compensation section 380 is shortened, resulting in an increase in its path length within length compensation section 380. Due to the inclined slot 303(1,1), the first slider 320 moves laterally upward over a distance H1, and the horizontal movement of steering wire 16(1,1) is equal to the distance La. This movement also moves a second slider 316, which is laterally connected to the first slider 320 but can move freely in the longitudinal direction, upward over a distance H2, where H1 = H2.

[0259] If the right steering wire portion 16e(2,1) is held stationary in a predetermined position by, for example, a steering input unit (manual or robotic) attached to the right steering wire portion 16e(2,1), the slot 310(2,1) where the projection 314(2,1) of the right steering wire portion 16e(1,2) is located extends laterally, so the second slider 316 does not move longitudinally when it moves laterally upward. The other inclined slot 308(2,1) of the second slider 316 causes the end of the left steering wire portion 16(2,1) attached to the projection 312(2,1) in the inclined slot 308(2,1) to be displaced longitudinally over a distance Lr when the second slider 316 moves laterally upward together with the first slider 320. If the inclination angle 90-α2 of slot 308(2,1) of the second slider 316 is the same as the inclination angle α1 of slot 303(1,1) of the first slider 320, then the displacement Lr of the left steering wire portion 16(2,1) will be exactly the same as the displacement La of the steering wire 16(1,1), and any undesirable change in the path length of the steering wire 16(2,1) will be compensated for.

[0260] If it is desired to steer the flexible region 152 at the tip of the device (for example, located on the left side in the drawing of Figure 40), the right steering wire portion 16e(2,1) can be pulled or pushed longitudinally (for example, manually or by a robotic device), and this movement also pulls or pushes the second slider 316 longitudinally. Since the left steering wire portion 16(2,1) is also connected to the second slider 316, the left steering wire portion 16(2,1) is also pulled or pushed longitudinally with the same longitudinal displacement as the right steering wire portion 16(2,1), and steering is achieved.

[0261] As explained below, it is observed that angle α1 can deviate from angle α2, such that displacements La and Lr may differ.

[0262] The internal friction and the actuating force in the length compensation section 380 strongly depend on the inclination angles α1 and 90 - α2 of the respective slots 303(1,1) and 308(2,1). For example, when the slot 303(1,1) of the first slider 320 is close to the longitudinal direction, the actuating force required to move the slider 320 upward together with the steering wire 16(1,1) is very small, and it can be understood that the friction between the projection 305(1,1) and the slot 303(1,1) is also very small. However, when the slot 303(1,1) of the first slider 320 is close to the lateral direction, a very high actuating force is required to move the first slider 320 upward (or downward), and it can be understood that the friction between the projection 305(1,1) and the slot 303(1,1) is also very high. At the same time, the angle α2 should be minimized so that when the first and second sliders 320 and 316 move up and down, the projection 312(2,1) can slide in the slot 308(2,1) with minimal friction, but when pulling or pushing the right steering wire portion 16(2,1), the projection 312(2,1) is prevented from easily sliding in the slot 308(2,1). Therefore, it can be concluded that the inclination angles α1 and α2 must be minimized as much as possible in order to maintain the friction and the actuating force at an acceptable level. In the above example, when it is desired to minimize the inclination angles α1 and α2 of both slots 303(1,1) and 308(2,1) for a given displacement La, Lr and H1, H2, these inclination angles must be approximately 45 degrees. The appropriate design range for both of them is 10 to 45 degrees.

[0263] The mechanism of FIG. 40 can be further optimized with respect to friction, actuating force, and the resulting length compensation when it is possible to minimize the inclination angle in combination with a given length displacement La and Lr (Lr is preferably equal to La in order to obtain accurate length compensation).

[0264] It can be seen that Figure 40 is merely an example. In alternative embodiments not shown, slot 308(2,1) is not angled with respect to the longitudinal direction and extends laterally. In that case, slot 310(2,1) is angled with respect to the longitudinal direction but mirrors the direction of slot 303(1,1) in a plane perpendicular to the longitudinal direction (and the direction of slot 308(2,1) in Figure 41).

[0265] In further embodiments, both slots 308(2,1) and 310(2,1) can be angled with respect to the longitudinal direction, mirrored with respect to a plane perpendicular to the longitudinal direction (see Figures 43 and 45).

[0266] Figure 41 shows an example of a length compensation section 380 having two steering wires 16(1,1) and 16(1,2) configured to steer the deflection of a flexible region 154, and two steering wires 16(2,1) and 16(2,3) configured to steer a flexible region 152. The same reference numerals used in Figure 40 refer to the same components in Figure 41. This example has the same structure as the example in Figure 40 for the additional steering wires 16(1,2) and 16(2,3). In the implementation of the example with a coaxial tube, the steering wires 16(1,1) and 16(1,2) are located on the opposite side of the fixture, i.e., rotated 180 degrees tangentially. In such an implementation of this example, the steering wires 16(2,1) and 16(2,3) are also located on the opposite side of the fixture, i.e., rotated 180 degrees tangentially. Furthermore, steering wires 16(1,1) and 16(2,1) are located on the same side of the device, and steering wires 16(1,2) and 16(2,3) are located on the same side of the device. Figure 41 illustrates the principle of the example in 2D. However, it can be easily implemented using coaxial tubes and (laser) cutting patterns, as described below.

[0267] Figure 41 shows steering wires 16(1,1), 16(1,2), 16(2,1), and 16(2,3), which are guided by the surrounding structure so that they can move only in the longitudinal direction and cannot move vertically or perpendicular to the plane of the drawing. Since steering wires 16(1,1) and 16(2,1) are located on the same side of the fixture, a change in the path length of one steering wire 16(1,1) and 16(2,1) caused by a deflection in one of the flexible regions 152 and 154 inside the fixture is the same as a change in the path length of the other steering wire 16(1,1) and 16(2,1). Since the steering wires 16(1,2) and 16(2,3) are located on the same side of the device, the change in the path length of one steering wire 16(1,2) and 16(2,3) caused by the deflection of one of the flexible regions 152 and 154 inside the device is the same as the change in the path length of the other steering wire 16(1,2) and 16(2,3).

[0268] More specifically, Figure 41 shows walls 382, ​​384, and 386 extending laterally perpendicular to the longitudinal direction of steering wires 16(1,1), 16(1,2), 16(2,1), and 16(2,3).

[0269] The steering wire 16(2,1) is shown to have a left portion 16(2,1) and a right portion 16e(2,1) extending through the wall 384. The steering wire 16(2,3) is shown to have a left portion 16(2,3) and a right portion 16e(2,3) extending through the wall 384. The first slider 320 is provided with a further opening 328 for accommodating a third slider 318, the third slider 318 being able to slide back and forth within the opening 328 in a direction parallel to the longitudinal direction, as indicated by the double horizontal arrows.

[0270] The right steering wire portion 16e(2,1) extends through an opening in wall 384 and is provided with a projection 305(2,1) that extends into the inner slot 303(2,1) of slider 322. Slider 322 is positioned between walls 384 and 386 so that it can move only up and down between them, as indicated by the double vertical arrows. Here, slot 303(2,1) is straight and may be oriented at the same angle as slot 303(1,1) with respect to the longitudinal direction.

[0271] Here, the steering wire 16(1,2) extends into the space between walls 382 and 384 through a suitable opening in wall 382. The steering wire 16(1,2) may be provided with projections such as pins 305(1,2) that extend into the inner slot 303(1,2) of the first slider 320. Here, the slot 303(1,2) is linear and extends at the same angle α1 as the slot 303(1,1), but is mirrored in a plane perpendicular to its longitudinal direction.

[0272] The steering wire portion 16(2,3) also extends into the space between the first wall 382 and the second wall 384 through a suitable opening in the wall 382. The left steering wire portion 16(2,3) may be provided with a projection such as a pin 312(2,3) that extends into the inner slot 308(2,3) of the second slider 318. Here, the slot 308(2,3) is linear and extends at the same angle α2 as the slot 303(2,1), but is mirrored in a plane perpendicular to its longitudinal direction.

[0273] The steering wire portion 16e(2,3) also extends into the space between the first wall 382 and the second wall 384 through a suitable opening in the second wall 384. The steering wire portion 16e(2,3) may be provided with projections such as pins 314(2,3) that extend into the inner slot 310(2,3) of the second slider 316. Here, the slot 310(2,3) is linear and extends laterally, similar to the slot 303(1,1).

[0274] The right steering wire portion 16e(2,3) extends through an opening in the wall 384 and is provided with a projection 305(2,3) that extends into the inner slot 303(2,3) of the slider 322. Here, the slot 303(2,3) is linear and may be oriented at the same angle as the slot 303(1,2) with respect to the longitudinal direction.

[0275] When the flexible region 154 is deflected by the steering wire 16(1,1), how the structural setup for the steering wires 16(1,1) and 16(2,1) compensates for undesirable changes in the path length of the steering wire 16(2,1) within the flexible region is described above. Furthermore, the method by which the most distal flexible region 152 can be steered independently of the steering of the flexible region 154 using this structure is described above.

[0276] Those skilled in the art will understand that the structure of the length compensation section 380 in Figure 41 relating to steering wires 16(1,2) and 16(2,3) operates in the same manner as the steering wires 16(1,1) and 16(2,1). The operation of the overall structure in Figure 41 is described below.

[0277] When slider 320 is moved upward and slider 322 is kept stationary, projection 305(1,1) moves to the right within inclined slot 303(1,1), forcing steering wire 16(1,1) to move the same amount to the right. Projection 305(1,2) is moved to the left within inclined slot 303(1,2), forcing steering wire 16(1,2) to move to the left by the same amount. Because slots 303(1,1) and 303(1,2) have the same angle but are mirror images of each other, the longitudinal movements of steering wires 16(1,1) and 16(1,2) are the same but in opposite directions. Steering wire 16(1,1) is pulled and steering wire 16(1,2) is pushed, causing the flexible region 154 to flex.

[0278] Changes in the path lengths of steering wires 16(2,1) and 16(2,3) within the deflected flexible region 154 are compensated because steering wire 16(2,1) moves to the right within slot 308(2,1) and steering wire 16(2,3) moves to the left within slot 308(2,3).

[0279] If the angles of slots 303(1,1) and 308(2,1) with respect to the longitudinal direction are equal, the path length compensation is perfect. However, these angles may differ, as shown in the example in Figure 41. If they differ, the compensation is not perfect, and the flexible region 152 will also flex to a certain extent. This may be desirable in some situations, depending on the curvature of the winding path in which the fixture will be used, or the expected operation.

[0280] The same applies to the angles of slots 303(1,2) and 308(2,3). However, it should be noted that the angles of slots 303(1,2) and 308(2,3) with respect to the longitudinal direction are identical, since steering wires 16(2,1) and 16(2,3) should move to the same extent in opposite directions, but they should be mirrored with respect to the cross-section.

[0281] The setup in Figure 41 allows for independent control of the bending region 152 even when the bending region 154 is bending. For example, when slider 316 is moved upward and the bending region 154 is bending, and then slider 322 is moved upward, both projections 305(2,1) and 305(2,3) are moved to the right within their respective slots 303(2,1) and 303(2,3). As a result, projection 314(2,1) is located within slot 310(2,1) which extends only laterally, so slider 316 moves to the right within the opening 326 without applying an upward or downward force to slider 316. Furthermore, this causes the projection 314(2,3) to be located within the slot 310(2,3), which similarly extends only laterally, so that the slider 318 moves to the left within the opening 328 without applying any upward or downward force to the slider 318.

[0282] This is shown in Figure 42. In Figure 42, slider 320 is moved upward to flex the flexible region 154, and slider 322 is moved upward to flex the flexible region 152, i.e., the device is in the state schematically shown in Figure 39B.

[0283] The internal friction and operating force in the length compensation mechanism strongly depend on the inclination angles of slots 303(1,1), 303(1,2), 303(2,1), 303(2,3), 308(2,1), and 308(2,3). To optimize the friction and operating force, slots 310(2,1) and 310(2,3) can also be provided, having angles deviated from 90 degrees with respect to the longitudinal direction.

[0284] An example of slot 310(2,1) is shown in Figure 43. In Figure 43, both slot 310(2,1) and slot 308(2,1) have an inclination angle β with respect to the longitudinal direction, which is mirrored with respect to a plane perpendicular to the longitudinal direction. Slot 303(1,1) is shown to have an inclination angle α with respect to the longitudinal direction. In Figure 43, α = 2 * β. The maximum horizontal displacement of steering wire 16(1,1) and projection 305(1,1) in length compensation section 380 is La. The maximum horizontal displacements of projection 312(2,1) and projection 314(2,1) in length compensation section 380 are Lr1 and Lr2, respectively, where La = Lr1 + Lr2. The maximum horizontal displacement of steering wire 16(2,1) in length compensation section 380 should be the same as the maximum horizontal displacement of steering wire 16(1,1), i.e., it should be La (in the case of desired perfect compensation). However, this horizontal displacement of the steering wire 16(2,1) within the length compensation section 380 is handled by both the inclined slots 308(2,1) and 310(2,1) as well as the slider 316. That is, for example, if the slider 320 moves upward, the steering wire 16(1,1) moves to the right along distance La, and the steering wire portion 16e(2,1) does not act (to prevent the flexible region 152 from bending), then the slider 316 moves upward with the slider 320, so that projection 312(2,1) moves to the right along distance Lr1 and projection 314(2,1) moves to the left along distance Lr2.

[0285] In the case of Figure 43, the compensation for α = 2*β is complete. However, slots 308(2,1) and 310(2,1) can be provided with different angles β1 and β2, respectively, so that α can deviate from β1 + β2. In that case, the path length compensation is not complete, and as schematically shown in Figures 44A and 44B, when the flexible region 154 is bent by moving the slider 320 / 316 up or down, the flexible region 152 also bends to a greater or lesser extent. Note that β1 can deviate from β2, but α is still equal to β1 + β2 so that there is complete compensation.

[0286] Figure 45 shows a modified example of the length compensation structure shown in Figures 41 and 42.

[0287] With regard to the portion relating to length compensation of steering wires 16(2,1) and 16(2,3) due to the deflection of the flexible region 154 caused by steering wires 16(1,1) and 16(1,2), the structure in Figure 45 may be identical to one of the structures in Figures 41 and 42. However, in the example shown in Figure 45, the slots 310(2,1) and 310(2,3) have an inclined angle as shown in the embodiment of Figure 43.

[0288] In addition, Figure 45 shows a slider 324 that can move up and down as indicated by double arrows. The slider 324 includes slots 303(2,2) and 303(2,4), respectively, which house projections 305(2,2) and 305(2,4) attached to steering wires 16(2,2) and 16(2,4), respectively. Slots 303(2,2) and 303(2,4) have an angle of inclination with respect to the longitudinal direction. They are mirrored with respect to an orientation with respect to a plane perpendicular to the longitudinal direction. Their angles of inclination with respect to the longitudinal direction may be the same as those of slots 303(1,1) and 303(1,2), respectively.

[0289] The steering wires 16(2,2) and 16(2,4) are configured to deflect the flexible region 152 in a plane perpendicular to the plane in which the flexible region 152 can be deflected by the steering wires 16(2,1) and 16(2,3). In the coaxial tube configuration, they extend to the instrument side rotated 90 degrees tangentially with respect to the steering wires 16(1,1), 16(1,2), 16(2,1), and 16(2,3). Because they are located on the side of the instrument that does not bend in the same plane as the deflection plane of the flexible region 154, they are not connected to the length compensation structure inside the slider 320. That is, they are unaffected with respect to variations in path length when the steering wires 16(1,1) and 16(1,2) are operated to deflect the flexible region 154.

[0290] When the slider 324 is moved upward or downward, the steering wires 16(2,2) and 16(2,4) move in opposite longitudinal directions, causing the flexible region 154 to flex in a plane perpendicular to the deflection plane controlled by the steering wires 16(2,1) and 16(2,3). Thus, the flexible region 154 can flex in all directions.

[0291] Another method to address changes in path length may be to avoid them. In a simple configuration, this can be done as described with reference to Figures 46A and 46B, which illustrate the basic principle. These figures show flexible regions 152 and 154. Flexible region 154 can be bent in a single plane by two opposing steering wires 16(1,1) and 16(1,2) separated from each other by a well-designed spacer. Flexible region 152 can be bent by four steering wires 16(2,1), 16(2,2), 16(2,3) and 16(2,4). In flexible region 152, steering wires 16(2,1) and 16(2,3) are positioned opposite each other, i.e., rotated 180 degrees so as to be seen tangentially. In the flexible region 152, steering wires 16(2,2) and 16(2,4) are also positioned opposite each other, i.e., rotated 180 degrees tangentially. Between adjacent steering wires 16(2,1), 16(2,2), 16(2,3), and 16(2,4) there is an angular space extending at a tangential angle of approximately 90 degrees. These angular spaces accommodate appropriately designed spacers.

[0292] However, within the flexible region 154, steering wires 16(2,1) and 16(2,2) are positioned as close to each other as possible at a tangential angle as close to 90 degrees as possible from steering wires 16(1,1) and 16(1,2). In the illustrated embodiment, they extend longitudinally within the flexible region 154 and are separated by slots resulting from a material removal technique such as laser cutting, where these slots are located 90 degrees tangentially from steering wires 16(1,1) and 16(1,2).

[0293] Furthermore, within the flexible region 154, steering wires 16(2,3) and 16(2,4) are positioned as close to each other as possible at tangential angles as close to 90 degrees as possible from steering wires 16(1,1) and 16(1,2), and opposite to steering wires 16(2,1) and 16(2,2). In the embodiments of Figures 46A and 46B, they are separated by slots that extend longitudinally in the flexible region 154 and result from material removal techniques such as laser cutting. Here, these slots are rotated 90 degrees tangentially from steering wires 16(1,1) and 16(1,2) and are located on the opposite side of the slots that separate steering wires 16(2,1) and 16(2,2).

[0294] Here, as shown in Figure 46B, when steering wires 16(1,1) and 16(1,2) are manipulated to flex the flexible region 154, all steering wires 16(2,1), 16(2,2), 16(2,3), and 16(2,4) are also flexed in a plane parallel to the plane in which steering wires 16(1,1) and 16(1,2) are flexed. However, with respect to them, that plane is a neutral plane in the sense that they do not move in the longitudinal direction of the device. As a result, they do not suffer changes in path length and no compensation is required. The flexure of the flexible region 152 is separated as well as possible from the flexure of the flexible region 154.

[0295] In the illustrated configuration, within the flexible region 152, steering wires 16(2,1), 16(2,2), 16(2,3), and 16(2,4) are all positioned rotated tangentially at a 45-degree angle with respect to steering wires 16(1,1) and 16(1,2) inside the flexible region 154. However, this is not mandatory. This angle can vary. Steering wires 16(2,1), 16(2,2), 16(2,3), and 16(2,4) can be positioned at any desired tangential position within the flexible region 152. Between the flexible regions 152 and 154, there is a transition region in which steering wires 16(2,1), 16(2,2), 16(2,3), and 16(2,4) change their tangential positions.

[0296] It will be apparent that the same principle can be applied to any other number of steering wires for the flexible region 152. If there is only one steering wire 16(2,1), or two steering wires 16(2,1), 16(2,2), or three steering wires 16(2,1), 16(2,2), 16(2,3) to flex the flexible region 152, at least one of them can be precisely positioned tangentially to the steering wires 16(1,1) and 16(1,2) rotated by 90 degrees.

[0297] Embodiments in Figures 46A and 46B can be defined as follows when the flexible regions 152 and 154 are controlled by one or more steering wires. The present invention relates to a steering device comprising at least a first flexible region 152 and at least a second flexible region 154, wherein the second flexible region 154 is located proximal to the first flexible region 152, and the steering device comprises a first set of steering wires including at least one first steering wire 16(2,1) arranged to flex the first flexible region 152, and a second set including at least one second steering wire 16(1,1) arranged to flex the second flexible region 154 in a first plane. The steering wires include a first set of steering wires that are rotated 90 degrees tangentially with respect to the second set of steering wires in the second flexible region 154 and extend longitudinally within the second flexible region 154, and at least one of the first steering wires 16(2,1) is rotated tangentially with respect to the steering wire 16(1,1) in the second flexible region 154, deviating from 90 degrees and extending longitudinally within the first flexible region, such that the first flexible region can bend at least in a second plane different from the first plane.

[0298] If it is desired that the flexible region 152 be flexible in all directions, all steering wires for the flexible region 152 must be positioned inside the flexible region 154, as close as possible to the plane perpendicular to the plane in which the steering wires 16(1,1) and 16(1,2) are located.

[0299] Figures 47A to 47E show the five tubes 500 to 508 with (laser) cutting patterns, which can be implemented when they are inserted into each other in the order of 500, 502, 504, 506, and 508 and aligned coaxially, thus enabling the implementation of the path length compensation structure of Figure 45. The drawings are not necessarily to the same scale. The following describes in detail how the different elements of the different tubes are fitted together.

[0300] In one embodiment, these elements shown in these figures address steering in the flexible region and path length compensation at the distal end, and are located at the proximal end of the device. Flexible regions 152 and 154 are located at the distal end on the left side of these drawings but are not shown. In these figures, the same reference numbers as in previous figures refer to the same components. As to be understood, sliders 320, 322, and 324 are implemented by rotatable bushings made from one or more of the materials of these tubes. All steering wires / wire sections are strips made from one or more of the materials of these tubes. Furthermore, all other components are made from the materials of these tubes.

[0301] Implementations of the schematic examples in Figures 40-43 and 45 can be carried out according to the same principles shown in Figures 47A-47E. Furthermore, it will be apparent that the schematic examples in Figures 40-43 and 45 are several embodiments. The present invention also relates to embodiments in which there are three or more flexible regions that can be bent by a suitable steering wire in a 2D plane or 3D space.

[0302] Figure 47A shows a tube 500 that can be positioned around an inner tube, which is not shown. The tube 500 has a slot pattern cut from the tube material 501, for example, by a laser beam. In this figure, the steering wires 16(1,1), 16(1,2), 16(2,1), 16e(2,1), 16(2,2), 16(2,3), 16e(2,3), and 16(2,4) (parts) are visible. The steering wire portion 16e(2,3) is located on the rear side of the tube 500 and is rotated 180 degrees relative to the steering wire portion 16e(2,1), and is not visible. As seen in the tangential direction, steering wires (sections) 16(1,1), 16(2,1), 16e(2,1), and 16(2,2) extend rotated 180 degrees in the opposite direction to steering wires (sections) 16(1,2), 16(2,3), 16e(2,3), and 16(2,4), respectively. All steering wires can move only in the longitudinal direction. Steering wire sections 16e(2,1) and 16e(2,3) can move in their longitudinal direction independently of steering wire sections 16(2,1) and 16(2,3), respectively.

[0303] Steering wires 16(1,1) and 16(2,1) extend adjacent to each other and parallel to one another. Their centerlines are located at a specific angular difference when viewed in a cross section perpendicular to the longitudinal direction. Furthermore, steering wires 16(1,2) and 16(2,3) extend adjacent to each other and parallel to one another. Their centerlines are also located at the same angular difference as steering wires 16(1,1) and 16(2,1) when viewed in a cross section perpendicular to the longitudinal direction. The exact value of the angle depends on the width of these steering wires, which in turn depends on the required strength of these steering wires.

[0304] Steering wires 16(2,2) and 16(2,4) are located opposite each other on the sides of the tube 500, rotated substantially 90 degrees with respect to the positions of steering wires 16(2,1) and 16(2,3).

[0305] Figure 47B shows a tube 502 having a notched slot pattern that includes sliders 305t(1,1), 312t(2,1), 314t(2,1), 305t(2,1), 305t(2,2), and 305t(2,4). These sliders 305t(1,1), 312t(2,1), 314t(2,1), 305t(2,1), 305t(2,2), and 305t(2,4) are positioned within their respective slots so that they can move longitudinally but not tangentially. These sliders 305t(1,1), 312t(2,1), 314t(2,1), 305t(2,1), 305t(2,2), and 305t(2,4) are part of the mounting configurations of projections 305(1,1), 312(2,1), 314(2,1), 305(2,1), 305(2,2), and 305(2,4), respectively. Slider 305t(1,1) is aligned and mounted on steering wire 16(1,1). Slider 312t(2,1) is aligned and mounted on steering wire 16(2,1). Slider 314t(2,1) is aligned and mounted on steering wire 16e(2,1). Slider 305t(2,1) is aligned with and mounted to steering wire 16e(2,1) more proximal to slider 314t(2,1). Sliders 305t(2,2) and 305t(2,4) are aligned with and mounted to steering wires 16(2,2) and 16(2,4), respectively. Tube 502 includes similar sliders [305t(1,2) and 305t(2,3)] aligned with and mounted to steering wires 16(1,2) and 16(2,3), respectively, but they are not visible.

[0306] Figure 47C shows a tube 504 with different sections 334a, 320a, 316, 318, 340a, 322a, 324a, and 336. Tube sections 334a, 340a, and 336 are neither rotatable nor longitudinally movable relative to each other. Tube sections 320a, 316, 318, 322a, and 324a are rotatable relative to tube sections 334a, 340a, and 336. The tube sections 320a, 322a, and 324a are components of the mounting configurations for slider 320 (further components are 320b, Figures 47D and 320c, and Figure 47E), slider 322 (further components are 322b, Figures 47D and 322c, and Figure 47E), and slider 324 (further components are 324b, Figures 47D and 324c, and Figure 47E), respectively. Due to their attachment to sections 320b, 322b, and 324b of the tube 506, these tube sections 320a, 322a, and 324a cannot move longitudinally relative to tube sections 334a, 340a, and 336 (see further below). The tube sections 316 and 318 are mounting configurations for the sliders 316 and 318, and can not only rotate but also move longitudinally relative to the tube sections 334a, 340a and 336.

[0307] All slots in sliders 320, 316, 318, 322, and 324 in Figure 45 are implemented as helical slots within a rotatable bushing. As shown in Figure 47C, slot 303(1,1) is a helical slot within the rotatable portion 320a having a pitch in a first direction. Slot 303(1,2) is a helical slot within the rotatable portion 320a having a pitch in a second direction opposite to the first direction. Slot 303(1,1) accommodates slider 305(1,1), which is a mounting configuration of projection 305(1,1). Slot 303(1,2) accommodates slider 305(1,2), which is a mounting configuration of projection 305(1,2) but is not visible in Figure 47C. Sliders 305(1,1) and 305(1,2) are attached to sliders 305t(1,1) and 305t(1,2) respectively by (laser) welding, and are therefore attached to steering wires 16(1,1) and 16(1,2) respectively.

[0308] Slot 308(2,1) is a helical slot in a rotatable and longitudinally movable portion 316, having a pitch in a first direction. The helical slot 308(2,1) houses a slider 312(2,1), which is an implementation of projection 312(2,1), and this slider 312(2,1) is attached to the steering wire 16(2,1) via a slider 312t(2,1) in the tube 502, for example, by (laser) welding. Slot 310(2,1) is a helical slot in a rotatable portion 316 having a pitch in a second direction. The helical slot 310(2,1) houses a slider 314(2,1), which is an implementation of the projection 314(2,1), and this slider 314(2,1) is attached to the steering wire 16e(2,1) via the slider 314t(2,1) inside the tube 502, for example, by (laser) welding.

[0309] Slot 308(2,3) is a helical slot in a rotatable and longitudinally movable portion 318 having a pitch in a second direction. The helical slot 308(2,3) houses a slider 312(2,3), which is an implementation of projection 312(2,3), and this slider 312(2,3) is attached to the steering wire 16(2,3) via slider 312t(2,3) in the tube 502, for example, by (laser) welding. Slot 310(2,3) is a helical slot in a rotatable portion 318 having a pitch in a first direction. The helical slot 310(2,3) accommodates the slider 314(2,3), which is an implementation of the projection 314(2,3). This slider 314(2,3) is attached to the steering wire 16e(2,3) via the slider 314t(2,3) inside the tube 502, for example, by (laser) welding. It can be observed that the sliders 312(2,3), 312t(2,3), 314(2,3), and 314t(2,3) are not visible in Figure 47C.

[0310] Slot 303(2,1) is a helical slot in the rotatable portion 322a having a pitch in a first direction. Slot 303(2,3) is a helical slot in the rotatable portion 322a having a pitch in a second direction. Slot 303(2,1) houses the slider 305(2,1), which is a mounting configuration of projection 305(2,1). Slot 303(2,3) houses the slider 305(2,3), which is a mounting configuration of projection 305(2,3) but is not visible in Figure 47C. Sliders 305(2,1) and 305(2,3) are attached to steering wires 16(2,1) and 16(2,3) respectively via sliders 305t(2,1) and 305t(2,3) in the tube 502, for example by (laser) welding.

[0311] Slot 303(2,2) is a helical slot in the rotatable portion 324a having a pitch in a first direction. Slot 303(2,4) is a helical slot in the rotatable portion 324a having a pitch in a second direction. Slot 303(2,2) accommodates a slider 305(2,2) which is a mounting form of projection 305(2,2). Slot 303(2,4) accommodates a slider 305(2,4) which is a mounting form of projection 305(2,4). Sliders 305(2,2) and 305(2,4) are attached to steering wires 16(2,2) and 16(2,4) via sliders 305t(2,2) and 305t(2,4) in the tube 502, respectively, for example by (laser) welding.

[0312] Figure 47D shows pipe 506. Pipe 506 has at least pipe sections 334b, 320b, 340b, 322b, and 324b. Pipe sections 334b ​​and 340b are attached to pipe sections 334a and 340a in pipe 504, respectively (Figure 47C).

[0313] The tube section 320b is part of the slider 320 and includes longitudinal slots 326 and 328. The longitudinal slot 326 accommodates a slider 330 mounted on the rotatable tube section 316 within the tube 504, so that the rotatable tube section 316 can slide longitudinally relative to the tube section 320b, for example, as slider 316 relative to slider 320 in Figure 45. The longitudinal slot 328 accommodates a slider 332 mounted on the rotatable tube section 318 within the tube 504, so that the rotatable tube section 318 can slide longitudinally relative to the tube section 320b, for example, as slider 318 relative to slider 320 in Figure 45. Such mounting can be done by (laser) welding.

[0314] The pipe sections 322b and 324b are rotatable and are attached to the rotatable sections 322a and 324a, respectively, within the pipe 504.

[0315] The tube sections 320b, 322b, and 324b can only rotate relative to the tube sections 334b ​​and 340b, and cannot move in the longitudinal direction, so that the sliders 320, 322, and 324 in Figure 45 can only move up and down and cannot move in the longitudinal direction.

[0316] Figure 47E shows a tube 508 with sections 334c, 344, 348, 340c, 322c, and 324c. Tube sections 322c and 324c are rotatable but not longitudinally movable relative to tube sections 334c and 340c. Tube sections 334c, 340c, 322c, and 324c are respectively attached to tube sections 334b, 340b, 322b, and 324b within tube 506 (Figure 47D).

[0317] The tubular portion 348 is a spring element formed by providing a tubular portion located between tubular portions 344 and 340c, having a helical shape that extends tangentially along a path of, for example, 360 degrees or more. Naturally, spring elements of other forms can be fabricated from the tubing 508 between tubular portions 344 and 340c, such as several tangentially distributed V-shaped bridges.

[0318] The tube sections 334c, 344 and the spring element 349 are configured such that, in a stationary state, the spring element 348 presses the tube section 344 against the tube section 334c. The surfaces of the opposing tube sections 334c and 344 are in contact with each other in a stationary state so as not to rotate relative to each other. These surfaces are serrated, for example, by a cutting pattern 346 appropriate in that regard. Thus, in a stationary state, the tube section 344 is locked to the tube section 334c. However, the tube section 344 can move away from the tube section 334c in the longitudinal direction indicated by the longitudinal arrow, against the spring action of the spring element 348, so that it can rotate relative to the tube section 334c.

[0319] The pipe section 344 has a slot 350 from which the slider 320c can move longitudinally. The slider 320c is attached to the rotatable pipe section 320b inside the pipe 506 (Figure 47D) by, for example, laser welding.

[0320] When in use, the apparatus having coaxial tubes 500-508 may be operated (partially) manually or (partially) by a robotic device as follows:

[0321] To initiate the operation of the device and flex one or more of the flexible regions 152, 154, the tube section 344 is moved longitudinally away from the tube section 344c against the spring force of the spring element 348. The slider 320c remains in position relative to the tube section 334c by sliding longitudinally within the slot 350. The tube section 344 can then be rotated, thereby also rotating the slider 320c. This also rotates the tube section 320b in the tube 506, as the slider 320c is attached to the tube section 320b. Since the tube section 320b is attached to the tube section 320a of the tube 504, the tube section 320a rotates in the same way, moving the steering wires 16(1,1) and 16(1,2) in opposite longitudinal directions and flexing the flexible region 154. The direction of deflection of the flexible region 154 can be controlled according to the rotation direction of the pipe sections 320a, 320b, and 320c.

[0322] Once the flexible region 154 has deflected to the desired extent, the tube portion 344 can be released and pressed against the tube portion 334c, locking it in place and allowing it to rotate. Thus, the amount of deflection of the flexible region 154 can also be locked.

[0323] When steering wires 16(1,1) and 16(1,2) move, causing this deflection in the deflectable region 154, the path lengths of steering wires 16(2,1) and 16(2,3) (see Figure 47A) change within the deflection region 154. This is compensated for a certain predetermined amount within the configurations of Figures 47A to 47E. This works as follows:

[0324] The tube section 320b rotates together with the tube section 320c. This causes the tube sections 316 and 318, both attached to the tube section 320b, to rotate. As a result, sliders 312(2,1) and 314(2,1) slide within slots 308(2,1) and 310(2,1), respectively, moving in opposite directions and causing the steering wire sections 16(2,1) and 16e(2,1) in the tube 500 to move in opposite directions. Furthermore, sliders 312(2,3) and 314(2,3) slide within slots 308(2,3) and 310(2,3), respectively, moving in opposite directions and causing the steering wire sections 16(2,1) and 16e(2,1) in the tube 500 to move in opposite directions. Thus, changes in path length are compensated. Depending on the pitch size of slots 308(2,1), 308(2,3), 310(2,1), and 310(2,3), the amount of compensation is either complete or incomplete. In the case of complete compensation, the deflectable region 152 remains straight. In the case of incomplete compensation, the deflectable region 152 is also deflected to a certain predetermined amount.

[0325] It will be apparent to those skilled in the art that the implementation configurations in Figures 47A to 47E can be simplified if a mechanism implementation configuration similar to that schematically shown in Figure 40, 41, 42, or 43 is desired. Next, elements of Figures 47A to 47E with reference numbers not shown in Figures 40, 41, 42, or 43 are simply omitted. Furthermore, it will be apparent to those skilled in the art that if a path length compensation mechanism fully implemented on the coaxial tube by an appropriate (laser) cutting pattern is desired for more complex steerable devices, such as devices having flexible regions in two or more directions, the mechanism can be added to the implementation configurations in Figures 47A to 47E.

[0326] The implementation configurations of the path length compensation mechanism shown in Figures 40, 41, 42, or 43 can be carried out in many different ways. For example, Figures 47A to 47E show steering wires fabricated entirely by (laser) cutting patterns so that the steering wires are all within a single tube, but this is only one option. The steering wires can be implemented by attaching two or more steering wire sections fabricated in different coaxial tubes to each other, for example, as described in International Publication No. 2017213491.

[0327] The attachment of different components of different coaxial tubes can be done by (laser) welding. However, other techniques can be used, such as a lip that is manufactured on a component of the first tube and bent into an opening of another component of the second tube, either inside or outside the first tube. Such a lip may be formed as described in International Publication No. 2023113598A2.

[0328] The rotation of the rotatable parts 320a, 316, 318, 322a, and 324a may be implemented by a motor and / or manually operated steering unit, as in the embodiments described above.

[0329] Figures 48A to 48E show alternative embodiments. Here, the steering wire length compensation mechanism for the flexible region 152 may be coupled to a tubular section that articulates the flexible region 154. In the example shown in Figures 48A to 48E, there are two flexible regions. As shown in Figures 47A to 47E, the most distal flexible region 152 can bend in all directions, while the other region 154 can bend in only one plane. Of course, this is just one example. The mechanism described with reference to Figures 48A to 48E can be applied to any steering mechanism having two or more flexible regions, which may be flexible in one or more planes or in all directions. In order to rotate the tubular section of tube 508 relative to the flexible region 154, the lower tubular sections of tubes 504 and 506 must be moved longitudinally so that they engage with the corresponding rotating cylinder of the flexible region 152, as will be described in detail below. As a result, when the flexible region 154 articulates, the steering wire in the flexible region 152, which is subject to a change in path length, also undergoes the same displacement, and these changes in path length can be automatically compensated for. Essentially, there is no separate compensation mechanism, but when the flexible region 154 articulates, the flexible region 152 also articulates automatically. Therefore, when the flexible region 152 articulates, the flexible region 154 may remain stationary with respect to its orientation. Here again, a compensation mechanism can be designed so that the flexible region 152 is automatically deflected by another predetermined angle, so that instead of the same displacement, only partial compensation exists.

[0330] In Figures 48A to 48E, the same reference numerals used in the previous figures refer to essentially the same elements. Details are as follows:

[0331] As shown in Figure 48A, the pipe 500 has steering wire sections 16(1,1), 16(1,2), 16(2,1), 16(2,2), 16(2,3), and 16(2,4). However, steering wire sections 16e(2,1) and 16e(2,3) are absent. The pipe 500 further has a rotatable pipe section 354 that cannot move in the longitudinal direction.

[0332] As shown in Figure 48B, the pipe 502 has sliders 305t(1,1), 305t(1,2), 305t(2,1), 305t(2,2), 305t(2,3) and 305t(2,4), which are slidable longitudinally within their respective slots and are attached to steering wire sections 16(1,1), 16(1,2), 16(2,1), 16(2,2), 16(2,3) and 16(2,4) within the pipe 502, respectively.

[0333] In the pipe 504 of Figure 48C, pipe section 320a is divided into two pipe sections 320a1 and 320a2, separated by pipe section 352. Pipe section 352 is attached to the material of pipe 502 so that it cannot move tangentially or longitudinally. Pipe section 320a2 can rotate and move longitudinally to a certain extent. Pipe section 320a1 includes helical slots 303(1,1) and 303(1,2), each having sliders 305(1,1) and 305(1,2), as shown in Figure 47C. In Figure 48B, sliders 305(1,1) and 305(1,2) are attached to sliders 305t(1,1) and 305t(1,2), respectively.

[0334] Pipe sections 316 and 318 do not exist.

[0335] The tubular section 322a is divided into two tubular sections 322a1 and 322a2. The tubular section 322a1 has an end facing the end of the tubular section 320a2. These two ends are configured so that when they are in contact with each other, they can rotate together by the same amount. This can be done by providing them with appropriately serrated, fitting sides so that they can be joined and separated. The tubular section 322a1 includes helical slots 303(2,1) and 303(2,3) having sliders 305(2,1) and 305(2,3) respectively, as shown in Figure 47C. Sliders 305(2,1) and 305(2,3) are mounted on sliders 305t(2,1) and 305t(2,3) respectively in Figure 48B.

[0336] Tube section 322a1 is attached to a rotatable tube section 354 of tube 502, so that tube section 322a1 can only rotate and cannot move longitudinally. Tube section 322a2 is both longitudinally movable and rotatable. Tube section 322a1 has an end facing the end of tube section 322a2. These two ends are configured so that they can rotate together to the same degree only when they are in contact with each other. This can be achieved by providing them with appropriately serrated, fitting sides so that they can be joined and separated.

[0337] The tube section 340a is located proximal to the tube section 322a2. It is not longitudinally movable and rotatable because it is properly attached to the material of the tube 502. The tube section 324a includes helical slots 303(2,2) and 303(2,4), each having sliders 305(2,2) and 305(2,4), respectively, as shown in Figure 47C. The sliders 305(2,2) and 305(2,4) are attached to sliders 305t(2,2) and 305t(2,4), respectively. Proximal to the tube section 324a, the tube 504 includes a tube section 358a attached to the tube 502 so that it cannot rotate or move longitudinally. Thus, the tube section 324a is rotatable only.

[0338] In the pipe 506 of Figure 48D, pipe section 320b is divided into two pipe sections 320b1 and 320b2, and pipe section 322b is divided into two pipe sections 322b1 and 322b2. Pipe section 320b1 is attached to pipe section 320a1. Pipe section 320b2 is attached to pipe section 320a2. Pipe section 320b2 is configured to be able to move longitudinally to a predetermined maximum range away from pipe section 320b1. The sides of the opposing pipe sections 320b1 and 320b2 are configured to remain joined regardless of how far they are longitudinally from each other, and are only able to rotate together.

[0339] Pipe section 322b cannot be attached to pipe section 322a1 by pipe 504, but it can be attached to pipe section 322a2. Pipe section 340b is divided into two sections 340b1 and 340b2, both of which can be attached to pipe section 340a, and pipe section 324b is attached to pipe section 324a. Furthermore, pipe sections 334b ​​and 358b are attached to pipe sections 334a and 358b, respectively.

[0340] As shown in Figure 48E, the tube portion 334c within the tube 508 is attached to the tube portion 334b. The tube portion 320c is here implemented by the tube portion 320c2 and two sliders 320c1 that can slide longitudinally within the respective appropriate slots of the tube portion 320c2. The tube portion 320c2 is attached to the tube portion 320b2, and the sliders 320c1 are attached to the tube portion 320b1. In the embodiment shown, the distal end of the tube portion 320c2 has a serrated surface that matches the serrated surface of the proximal end of the tube portion 334c, and therefore, when they engage, the tube portion 320c2 cannot rotate, preventing the tube portion 334c from rotating and thus preventing the tube portion 320c2 from rotating. However, in one embodiment, such a serrated surface is absent, and the tube portion 320c2 can rotate freely.

[0341] The pipe section 322c is here implemented by the pipe section 322c2 and a slider 322c1 which can slide longitudinally within a suitable slot in the pipe section 322c2. The slider 322c1 is attached to the pipe section 322a1. The pipe section 322c2 is optionally attached to the pipe section 356 of the pipe 506. The pipe sections 340c, 324c, and 358c are attached to the pipe sections 340b, 324b, and 358b of the pipe 506, respectively.

[0342] It is observed that the number of sliders 320c1, 320c2, and 322c1 can vary.

[0343] For clarity, all installations between pipes 500 and 502 are shown separately in Figures 49A to 49E. For simplicity of overview, the functions of pipe sections 320a1, 320a2, 320b1, 320b2, 320c1, and 320c2 are summarized by the letters A, A1, and A2. The functions of pipe sections 322a1, 322a2, 322b, 322c1, and 322c2 are summarized by the letters B, B1, and B2. The functions of pipe sections 334a, 334b, 334c, 340a, 340b1, 340b2, 340c, 358a, 358b, and 358c all function as "fixed worlds" and are summarized by the letters D, D1, and D2. Pipes 500, 502, 504, 506, and 508 are indicated by the letters L2, L3, L4, L5, and L6, respectively.

[0344] The functions of the devices shown in Figures 48A-48E and 49A-49E will be explained with reference to Figures 50A-50E and 51A-51E. These are identical to those in Figures 48A-48E, but arc-shaped and straight arrows have been added to illustrate the combined rotation and longitudinal movement. Furthermore, only the relevant mounting parts between pipes are shown.

[0345] First, refer to Figures 48A to 48E and 50A to 50E. If automatic path length compensation of steering wires 16(2,1) and 16(2,3) is desired due to the deflection of the flexible region 154 controlled by steering wires 16(1,1) and 16(1,2), first, as indicated by arrow T1, the tube section 320c2 in the tube 508 is moved longitudinally toward the tube section 322c2 against the action of the spring element 348. The tube section 320b2 in the tube 506 moves longitudinally away from the tube section 320b1 so as to be attached to the tube section 320c2, but only to the extent that the tube sections 320b1 and 320b2 can still rotate together. This is indicated by arrow T2. The tube section 320b2 pushes the tube 322b by the same amount longitudinally, as indicated by another arrow T2. The pipe section 320a2 of pipe 504 attached to pipe section 320b2 moves longitudinally to the same extent as indicated by arrow T3, and as a result it joins pipe section 322a1. At the same time, because pipe section 322a2 inside pipe 504 is attached to pipe section 322b1, pipe section 322a2 also moves longitudinally away from pipe section 322a1, as indicated by another arrow T3. In doing so, pipe section 322a2 is separated from pipe section 322a1.

[0346] Next, when pipe section 320c2 within pipe 508 is controlled to rotate either manually or robotically, as indicated by arrow R1 in Figure 50E, both pipe sections 320b1 and 320b2 are similarly rotated, as indicated by arrow R2 in Figure 50D. Then, pipe section 320a1 is rotated as indicated by arrow R3 in Figure 50C so as to attach to pipe section 320b1. Pipe section 320a2 is rotated as indicated by another arrow R3 in Figure 50C so as to attach to pipe section 320b2. Finally, pipe section 322a1 is rotated as indicated by another arrow R3 in Figure 50C so as to connect to pipe section 320a2.

[0347] The rotation R3 generated in the tube section 320a1 moves the sliders 305(1,1) and 305(1,2) longitudinally in predetermined opposite directions so as to deflect the flexible region 154 via the steering wires 16(1,1) and 16(1,2). Simultaneously, the combined rotation R3 in the tube section 322a1 moves the sliders 305(2,1) and 305(2,3) longitudinally in predetermined opposite directions so as to deflect the flexible region 152 via the steering wires 16(2,1) and 16(2,3). The pitch sizes of the slots 303(1,1), 303(1,2), 303(2,1), and 303(2,3) determine the relative angles of deflection in the flexible regions 152 and 154. As described above, the path length difference can thus be automatically compensated for completely or to a specific predetermined extent.

[0348] When tube section 320c2 is not moved toward tube section 322c2, in the shown embodiment, the tube section cannot rotate because it is prevented from doing so by being coupled to tube section 334c. However, if tube sections 320c2 and 334c do not have serrated sides, i.e., they are not coupled in a stationary state, tube section 320c2 can rotate as shown in Figure 48E, and both tube sections 320b1 and 320b2 (Figure 48D) and tube sections 320a1 and 320a2 (Figure 48C) rotate as well. As a result, the steering wires 16(1,1) and 16(1,2) move longitudinally in opposite directions, as described above, and therefore the flexible region 154 flexes. However, in this case, pipe section 320a2 is not connected to pipe section 322a1, and therefore pipe section 322a1 does not rotate, the steering wires 16(2,1) and 16(2,3) are subject to changes in path length, and the flexible region 152 is bent by these changes in path length.

[0349] As explained with reference to Figures 51A to 51E, the flexible region 152 can also be deflected independently of the deflection of the flexible region 154. In this sense, the pipe section 320c2 remains in a non-operating state (Figure 51E). The pipe section 322c2 is rotated either manually or robotically, as indicated by the arc-shaped arrow R4, which also rotates the slider 322c1. Since the slider 322c1 is attached to the pipe section 322b, the pipe section 322b also rotates, as indicated by the arrow R5. The pipe section 356 inside the pipe 506 is also rotated in the direction of arrow R5. This does not result in any further consequences.

[0350] Pipe section 322b is attached to pipe section 322a2, and as a result, pipe section 322a2 rotates as indicated by arrow R6. In this state, pipe sections 322a1 and 322a2 are connected so that pipe section 322a1 also rotates, as indicated by arrow R6. This moves sliders 305(2,1) and 305(2,3) in opposite longitudinal directions, causing the flexible region 152 to flex. Note that pipe sections 320c1 and 322c2 in pipe 508 in Figure 51E rotate independently and are not connected to other pipes, so the flexible region 154 is not flexed.

[0351] It will be apparent to those skilled in the art that the steering wires 16(2,2) and 16(2,4) can be controlled independently by controlling the rotation of the pipe section 508 within pipe 324c.

[0352] Overview The examples and embodiments described herein are illustrative, not limiting, of the invention. Those skilled in the art will be able to design alternative embodiments without departing from the claims. Reference numerals in parentheses within the claims should not be construed as limiting the claims. Items described in the claims or herein as separate entities may be implemented as one or more hardware items combining the features of the described items.

[0353] It should be understood that the present invention is limited only by the appended claims and its technical equivalents. In this specification and its claims, the verb “includes” and its conjugations are used in a non-restrictive sense to mean that the items following the word are included without excluding items not specifically mentioned. In addition, references to elements with the indefinite article “a” or “an” do not exclude the possibility of two or more elements being present unless the context explicitly requires that only one or one of the elements be present. Thus, the indefinite article “a” or “an” usually means “at least one.”

Claims

1. A steering device having at least one flexible region (13, 152, 154) at its distal end, comprising a first steering wire (16(1), 16(1,1), 429) attached to the at least one flexible region (13, 152, 154), wherein the first steering wire (16(1), 16(1,1), 429) is part of at least one tube (3, 102, 103, 121, 500) and is separated from the rest of the at least one tube (3, 102, 103, 121, 500) by a first material removal pattern, such that the first steering wire (16(1), 16(1,1), 429) extends from the proximal end to the distal end of the steering device, and the steering device A steering device comprising a steering unit including a first control tube portion (301a(i), 302a(1,3), 431, 320a) arranged coaxially with at least one tube (3, 500), wherein the first control tube portion (301a(i), 302a(1,3), 431, 320a) and the first steering wire (16(1), 16(1,1)) are configured such that rotation of the first control tube portion (301a(i), 302a(1,3), 431, 320a) causes longitudinal movement of the first steering wire (16(1), 16(1,1), 429) in a first longitudinal direction to flex the at least one flexible region (13, 152, 154) in a first plane.

2. The steering device according to claim 1, wherein the first control tube portion (301a(i), 320a) is provided with a first helical slot (303a(1), 303(1,1)), and the first sliding element (305a(1), 305(1,1)) attached to the first steering wire (16(1), 16(1,1)) is provided in the first helical slot (303a(1), 303(1,1)) such that the rotation of the first control tube portion (301a(i), 320a) causes the first steering wire (16(1), 16(1,1)) to move in the first longitudinal direction.

3. The steering device according to claim 1, wherein the first control tube portion is a sawtooth-shaped first control portion (431), and the steering device is provided with a gear (433) configured to convert the rotation of the first control tube portion (431) into longitudinal movement of the first steering wire (429).

4. The first control tube portion (302a(1,3), 431, 320a) and the second steering wire (16(3), 16(1,2), 435) are attached to the at least one flexible region (13, 152, 154), and the second steering wire (16(3), 16(1,2), 435) are also part of the at least one tube (3, 500), and the second steering wire (16(3), 16(1,2), 435) are separated from the other part of the at least one tube (3, 102, 103, 121, 500) by a second material removal pattern, such that the second steering wire (16(3), 16(1,2), 435) extend from the proximal end to the distal end, and the first control tube portion (302a(1,3), 431, 320a) and the second steering wire (16(3) The steering device according to claim 1, wherein the rotation of the first control tube portion (302a(1,3), 320a) causes longitudinal movement of the second steering wire (16(3), 16(1,2)) in a second longitudinal direction to cause the at least one flexible region (13, 152, 154)) to bend in the first plane, the second longitudinal direction being opposite to the first longitudinal direction, and the second steering wire (16(3), 16(1,2), 435) is optionally positioned tangentially rotated 180 degrees with respect to the first steering wire (16(1), 16(1,1)).

5. The steering device according to claim 4, wherein the first control tube portion (302a(1,3), 320a) is provided with a second helical slot (303a(3), 303(1,2)), and the second sliding element (305a(3), 305(1,2)) attached to the second steering wire (16(3), 16(1,2)) is provided in the second helical slot (303a(3), 303(1,2)) such that the rotation of the first control tube portion (302a(1,3), 320a) causes the second steering wire (16(3), 16(1,2)) to move in the second longitudinal direction.

6. The steering device according to claim 4, wherein the first control tube portion is a sawtooth-shaped first control tube portion (431), and the steering device is provided with a gear (433) configured to convert the rotation of the sawtooth-shaped first control tube portion (431) into the opposite longitudinal movement of the first and second steering wires.

7. The steering unit includes third and fourth steering wires (16(2), 16(4)) respectively attached to at least one flexible region (13, 154), the third and fourth steering wires (16(2), 16(4)) also being part of the at least one tube (3), and the third and fourth steering wires (16(2), 16(4)) being separated from the rest of the at least one tube (3, 102, 103, 121) by third and fourth material removal patterns, respectively, such that the third and fourth steering wires (16(2), 16(4)) extend from the proximal end to the distal end, and the steering unit includes a second control tube portion (302(2,4)) arranged coaxially with the at least one tube (3), the second control tube portion ( The steering device according to any one of claims 4 to 6, wherein the 302a(2,4)) and the third and fourth steering wires (16(2), 16(4)) are configured such that the rotation of the second control tube portion (302(2,4)) causes longitudinal movement of the third and fourth steering wires (16(2), 16(4)) in opposite longitudinal directions to cause the at least one flexible region (13, 152, 154)) to bend in a second plane angled with respect to the first plane, and the first, second, third and fourth steering wires (16(1), 16(2), 16(3), 16(4)) are optionally located equidistant from each other in the tangential direction of the steering device.

8. The steering device according to claim 7, wherein the second control tube portion (302(2,4)) is provided with third and fourth helical slots (303a(2), 303a(4)), and a third sliding element (305a(2)) attached to the third steering wire (16(2)) is provided in the third helical slot (303a(2)) and a fourth sliding element (305a(4)) attached to the fourth steering wire (16(4)) is provided in the fourth helical slot (303a(4)), such that rotation of the second control tube portion (302(2,4)) causes the third and fourth steering wires (16(2), 16(4)) to move in the opposite longitudinal direction, and a fourth sliding element (305a(4)) attached to the fourth steering wire (16(4)) is provided in the fourth helical slot (303a(4)).

9. The steering device according to claim 7, wherein the second control tube portion is a sawtooth-shaped second control tube portion, and the steering device is provided with gears configured to convert the rotation of the sawtooth-shaped second control tube portion into the opposite longitudinal movement of the third and fourth steering wires.

10. The steering device according to claim 2, comprising a further tube (4, 104, 203, 502) coaxially positioned between the at least one tube (3, 101, 102, 121, 500) and the first control tube portion (301a(i), 320a), wherein the further tube is provided with a first longitudinal slot (309(1)), and the first sliding element (305a(1), 305(1,1)) is attached to the first steering wire (16(1), 16(1,1)) through the first longitudinal slot (309(1)).

11. The steering device according to claim 10, wherein the first sliding element includes a first sliding pin (305a(1), 305(1,1)), and the further tube includes a second sliding pin (307(1), 305t(1,1)) attached to both the first sliding pin (305a(1), 305(1,1)) and the first steering wire (16(1), 16(1,1)).

12. The steering device according to claim 5, comprising a further tube (4, 104, 203, 502) coaxially positioned between the at least one tube (3, 101, 102, 121, 500) and the first control tube portion (302a(1,3), 320a), wherein the further tube is provided with a first longitudinal slot (309(1)) and a second longitudinal slot (309(3)), a first sliding element (305a(1), 305(1,1)) being attached to the first steering wire (16(1), 16(1,1)) through the first longitudinal slot (309(1)), and a second sliding element (305a(3), 305(1,2)) being attached to the second steering wire (16(3), 16(1,2)) through the second longitudinal slot (309(3)).

13. The steering device according to claim 12, wherein the first sliding element includes a first sliding pin (305a(1), 305(1,1)), the further tube includes a second sliding pin (307(1), 305t(1,1)) attached to both the first sliding pin (305a(1), 305(1,1)) and the first steering wire (16(1), 16(1,1)), the second sliding element includes a third sliding pin (305a(3), 305(1,2)), and the further tube includes a fourth sliding pin (307(3), 305t(1,2)) attached to both the third sliding pin (305a(3), 305(1,2)) and the second steering wire (16(3), 16(1,2)).

14. A steerable device according to any one of claims 10 to 13, comprising: a first component (321) attached to the further pipe (203) distal to the first control pipe portion (301a(i), 302a(1,3)) so as to prevent longitudinal movement of the first control pipe portion (301a(i), 302a(1,3)); and a second component (323) attached to the further pipe (203) proximal to the first control pipe portion (301a(i), 302a(1,3)).

15. A steerable device according to any one of claims 1 to 14, comprising a longitudinal slider (331a) having a third helical slot (335a), wherein a third sliding element (333a) attached to the first control tube portion (301a(i), 302a(1,3)) is provided in the third helical slot (335a) such that longitudinal movement of the longitudinal slider (331a) causes rotation of the first control tube portion (301a(i), 302a(1,3)).

16. The further tubes (4, 104, 203) are coaxially positioned between the at least one tube (3, 101, 102, 121) and the first and second control tube portions (302a(1,3), 302(2,4)), and the further tubes are provided with a first longitudinal slot (309(1)), a second longitudinal slot (309(3)), a third longitudinal slot (309(2)), and a fourth longitudinal slot (309(4)), and the first sliding element (305a(1)) is connected to the first steering wire through the first longitudinal slot (309(1)). The steering device according to claim 8, wherein the second sliding element (305a(3)) is attached to 16(1)), the second sliding element (305a(3)) is attached to the second steering wire (16(3)) through the second longitudinal slot (309(3)), the third sliding element (305a(2)) is attached to the third steering wire (16(2)) through the third longitudinal slot (309(2)), and the fourth sliding element (305a(4)) is attached to the second steering wire (16(3)) through the fourth longitudinal slot (309(4)).

17. The first sliding element includes a first sliding pin (305a(1)), the further tube includes a second sliding pin (307(1)) attached to both the first sliding pin (305a(1)) and the first steering wire (16(1)), the second sliding element includes a third sliding pin (305a(3)), the further tube includes a fourth sliding pin (307(3)) attached to both the third sliding pin (305a(3)) and the second steering wire (16(3)), and the third sliding element The steering device according to claim 16, wherein the element includes a fifth sliding pin (305a(2)), the further tube includes a sixth sliding pin (307(2)) attached to both the fifth sliding pin (305a(2)) and the third steering wire (16(2)), the fourth sliding element includes a seventh sliding pin (305a(4)), and the further tube includes an eighth sliding pin (307(4)) attached to both the seventh sliding pin (305a(4)) and the fourth steering wire (16(4)).

18. A steerable device according to claim 16 or 17, comprising: a first component (321) attached to the further pipe (203) distal to the first control pipe portion (302a(1,3)), a second component (323) attached to the further pipe (203) proximal to the first control pipe portion (302a(1,3)), a third component (323) attached to the further pipe (203) distal to the second control pipe portion (302a(2,4)), and a fourth component (327) attached to the further pipe (203) proximal to the second control pipe portion (302a(2,4)), so as to prevent longitudinal movement of the first and second control pipe portions (302a(1,3), 302a(2,4)).

19. A longitudinal slider (331a) is connected to the first control tube portion (302a(1,3)) such that longitudinal movement of the longitudinal slider (331a) causes rotation of the first control tube portion (302a(1,3)), and a slider (349a) is connected to the second control tube portion (302a(2,4)) such that rotation of the slider (349a) causes rotation of the second control tube portion (302a(2,4)), and A steerable device according to claim 8 or any one of claims 16 to 18, comprising a connecting component (359) that connects the longitudinal slider (331a) and the slider (349a) such that when the connecting component (359) moves in the longitudinal direction, it causes longitudinal movement of the longitudinal slider (331a), and when the connecting component (359) rotates, it causes rotational movement of the slider (349a), wherein the connecting component (359) may have a tubular shape.

20. The slider (349a) is provided with a fifth longitudinal slot (351a) for accommodating a ninth sliding pin (353a), the longitudinal slider (331a) is provided with a third helical slot (335a) and a tangential slot (355a) for accommodating a tenth sliding pin (357a), the third sliding element (333a) attached to the first control tube portion (301a(i), 302a(1,3)) is provided in the third helical slot (335a), and the connecting component (3 59) The steering device according to claim 19, wherein the slider (349a) is attached to both the 10th sliding pin (357a) and the 9th sliding pin (353a) while the slider (349a) is attached to the second control tube portion (302a(2,4)), or the 9th sliding pin (353a) is attached to both the 10th sliding pin (357a) and the slider (349a) while the 9th sliding pin (353a) is attached to the second control tube portion (302a(2,4)).

21. A drive element (331a, 359, 447) is connected to the first control tube portion (302a(1,3)) such that longitudinal movement of the drive element (359, 447) causes rotation of the first control tube portion (302a(1,3)) in a first tangential direction, wherein longitudinal movement of the drive element (359, 447) causes rotation of the second control tube portion (302a(2) in a second tangential direction opposite to the first tangential direction. The steering device according to any one of claims 8, 9, or 16 to 18, wherein the drive element (359, 447) is connected to the second control tube portion (302a(2,4)) so as to cause rotation in ,4), and the drive element (359, 447) is also connected to the first and second control tube portions (302a(1,3), 302a(2,4)) so as to cause tangential rotation of the drive element (359, 447) to cause tangential rotation of both the first and second control tube portions (302a(1,3), 302a(2,4)) in the same direction.

22. The steering device according to claim 21, dependent on claim 8 or any one of claims 16 to 18, wherein the drive element (331a) is a third helical slot (335a), and a third sliding element (333a) attached to the first control tube portion (302a(1,3)) includes a third helical slot (335a) provided in the third helical slot (335a), and a fourth helical slot (335a), and a fourth sliding element (333a) attached to the second control tube portion (302a(2,4)) includes a fourth helical slot (335a) provided in the fourth helical slot (335a).

23. The steering device according to claim 21, dependent on claim 9, wherein the driving element includes a tubular driving element (447) having a sawtooth opening for housing a gear (450), the tubular driving element (447) is configured to rotate the gear (450) when the tubular driving element (447) moves in the longitudinal direction, and the gear (450) is configured to rotate first and second sawtooth-shaped control tube portions (443, 445) in opposite tangential directions when it rotates.

24. The steering device includes at least a first flexible region (154) and a second flexible region (152), the first flexible region (154) being located proximal to the second flexible region (152), the first steering wire (16(1,1)) being attached to the first flexible region (154), and the steering device includes a fifth steering wire (16(2,1), 16e(2,1)) attached to the second flexible region (152), and the fifth The steering wires (16(2,1), 16e(2,1)) are part of the at least one tube (500) and are separated from the rest of the at least one tube (500) by a fifth material removal pattern so that the fifth steering wires (16(2,1), 16e(2,1)) extend from the proximal end to the distal end of the steering device and are configured to flex the second flexible region (152) and the first flexible region ( The deflection of 154) causes a change in the path length of the fifth steering wire (16(2,1), 16e(2,1)) inside the first flexible region (154), the fifth steering wire having a first portion (16(2,1)) extending toward the distal end and a second portion (16e(2,1)) located proximal to the first portion (16(2,1)), the first control tube portion (320a) and the first and second of the fifth steering wire The steering device according to any one of claims 1, 2, 4, 5, 10, 11, 12, or 13, wherein the portion (16(2,1), 16e(2,1)) is configured such that the rotation of the first control tube portion (320a) causes at least one of the first and second portions (16(2,1), 16e(2,1)) of the fifth steering wire to move longitudinally toward or away from each other.

25. The steering unit includes sixth and seventh steering wires (16(2,2), 16(2,4)) respectively attached to the second flexible region (152), the sixth and seventh steering wires (16(2,2), 16(2,4)) are also part of the at least one tube (500), and the sixth and seventh steering wires (16(2,2), 16(2,4)) are separated from the rest of the at least one tube (500) by sixth and seventh material removal patterns, respectively, so that they extend from the proximal end to the distal end, and the steering unit is the at least The steering device according to claim 24, further comprising a second control tube portion (324a) arranged coaxially with another tube (500), wherein the second control tube portion (324a) and the sixth and seventh steering wires (16(2,2), 16(2,4)) are configured such that rotation of the second control tube portion (324a) causes longitudinal movement of the sixth and seventh steering wires (16(2,2), 16(2,4)) in opposite longitudinal directions to flex the second flexible region (152) in a second plane angled with respect to the first plane.

26. The steering device according to claim 25, wherein the second control tube portion (324a) is provided with third and fourth helical slots (303(2,2), 303(2,4)), and a third sliding element (305(2,2)) attached to the third steering wire (16(2,2)) is provided in the third helical slot (303(2,2)), and a fourth sliding element (305(2,4)) attached to the fourth steering wire (16(2,4)) is provided in the fourth helical slot (303(2,4)), such that rotation of the second control tube portion (324a) causes the sixth and seventh steering wires (16(2,2), 16(2,4)) to move in the opposite longitudinal direction, and a fourth sliding element (305(2,4)) attached to the fourth steering wire (16(2,4)) is provided in the fourth helical slot (303(2,4)).

27. A third control tube portion (316) is arranged coaxially with at least one tube (500), and is configured to rotate tangentially with the first control tube portion (320a) and is also movable in the longitudinal direction, the third control tube portion (316) includes a fifth slot (308(2,1)) and a sixth slot (310(2,1)), and is attached to the first portion (16(2,1)) of the fifth steering wire. A steering device according to any one of claims 24 to 26, wherein a fifth sliding element (312(2,1)) is provided in the fifth slot (308(2,1)), and a sixth sliding element (314(2,1)) attached to the second portion (16e(2,1)) of the fifth steering wire is provided in the sixth slot (310(2,1)), and at least one of the fifth slot (308(2,1)) and the sixth slot (310(2,1)) is helical.

28. An eighth steering wire (16(2,3), 16e(2,3)) attached to the second flexible region (152), which is part of the at least one tube (500) and is separated from the rest of the at least one tube (500) by an eighth material removal pattern such that the eighth steering wire (16(2,3), 16e(2,3)) extends from the proximal end to the distal end of the steering device, and includes the eighth steering wire (16(2,3), 16e(2,3)) configured to deflect the second flexible region (152) together with the fifth steering wire (16(2,1)), the deflection of the first flexible region (154) is due to the eighth steering wire (16(2,3), 16e(2, 3)) causing a change in the path length, the steering device according to any one of claims 24 to 26, dependent on claim 4 or 5, wherein the eighth steering wire has a first portion (16(2,3)) extending toward the distal end and a second portion (16e(2,3)) located proximal to the first portion (16(2,3)), and the first control tube portion (320a) and the first and second portions (16(2,3), 16e(2,3)) of the eighth steering wire are configured such that rotation of the first control tube portion (320a) causes at least one of the first and second portions (16(2,3), 16e(2,3)) of the eighth steering wire to move longitudinally toward or away from each other.

29. A fourth control tube portion (318) is arranged coaxially with at least one tube (500), and is configured to rotate tangentially with the first control tube portion (320a) and is also movable in the longitudinal direction, the fourth control tube portion (318) includes a seventh slot (308(2,3)) and an eighth slot (310(2,3)), and the eighth steering wire is connected to the first portion (16(2,3)) The steering device according to claim 28, wherein a mounted seventh sliding element (312(2,3)) is provided in the fifth slot (308(2,3)), and an eighth sliding element (314(2,3)) mounted on the second portion (16e(2,3)) of the eighth steering wire is provided in the eighth slot (310(2,3)), and at least one of the seventh slot (308(2,3)) and the eighth slot (310(2,3)) is helical.

30. The steering device according to claim 28 or 29, comprising a fifth control tube portion (322a), wherein the fifth control tube portion (322a) and the fifth and eighth steering wires (16(2,1), 16(2,3)) are configured such that rotation of the fifth control tube portion (322a) causes longitudinal movement of the fifth and eighth steering wires (16(2,1), 16(2,3)) in opposite longitudinal directions.

31. The steering device includes at least a first flexible region (154) and a second flexible region (152), the first flexible region (154) being located proximal to the second flexible region (152), the first steering wire (16(1,1)) being attached to the first flexible region (154), and the steering device includes a fifth steering wire (16(2,1)) attached to the second flexible region (152), the fifth steering wire (16(2,1)) being part of the at least one tube (500), and being separated from the rest of the at least one tube (500) by a fifth material removal pattern so as to extend from the proximal end to the distal end of the steering device, and is configured to flex the second flexible region (152). The steering device according to any one of claims 1, 2, 4, 5, 10, 11, 12, or 13, wherein the deflection of the first flexible region (154) causes a change in the path length of the fifth steering wire (16(2,1)) inside the first flexible region (154), and the steering device includes a sixth control tube portion (322a) that can be coupled to and separated from the first control tube portions (320a1, 320a2), the sixth control tube portion (322a) and the fifth steering wire (16(2,1)) are configured such that rotation of the sixth control tube portion (322a) causes longitudinal movement of the fifth steering wire (16(2,1)), and the first control tube portions (320a1, 320a2) and the sixth control tube portion (322a) are configured to rotate together when they are coupled.

32. A steering device having at least one flexible region (13, 152, 154) distal to the steering device, comprising a first steering wire (16(1), 429) attached to the at least one flexible region (13, 152, 154), wherein the first steering wire (16(1), 429) is part of at least one tube (3, 102, 103, 121) and is separated from the rest of the at least one tube (3, 102, 103, 121) by a first material removal pattern such that the first steering wire (16(1), 429) extends from the proximal end to the distal end of the steering device, and longitudinal movement of the first steering wire (16(1), 429) is within the at least one flexible region (13, 152, 154) in a first plane. A steering device that causes a deflection, and the steering device includes a steering unit including at least one longitudinal control element (421(1,2)) and a first control tube portion (301a(i), 302a(1,3), 431) arranged coaxially with the at least one tube (3), wherein the first control tube portion (301a(i), 302a(1,3), 431) and the at least one longitudinal control element (421(1,2)) are configured such that the rotation of the first control tube portion (301a(i), 302a(1,3)) causes longitudinal movement of the at least one longitudinal control element (421(1,2)) to control a function of the steering device, such as locking or unlocking a bend in the device or operating a tool located at the distal end.

33. The first longitudinal control element (421(1,2)) is connected at its proximal end to the first control tube portion (302a(1), 302a(1,3)) and at its distal end to the first steering wire (16(1)) and the second steering wire (16(2)) via a gear configuration (401(1,2), 401(1,2), 403(1), 403(2)). The steering device according to claim 32, wherein the longitudinal movement of the first longitudinal control element (421(1,2)), 403(1), 403(2)) is configured such that longitudinal movement of the first longitudinal control element (421(1,2)) results in longitudinal movement of both the first and second steering wires (16(1), 16(2)) in the same longitudinal direction, and the gear configuration is configured to compensate for the difference in path length between the first and second steering wires (16(1), 16(2)).

34. The steering device according to any one of claims 1 to 33, wherein at least one tube (3, 102, 103, 121) includes a ring-shaped end portion (314) at its distal end to which the first steering wire (16(1)) is attached.

35. The components of the aforementioned device are a combination of the following materials: Biocompatible polymer materials including polyurethane, polyethylene, or polypropylene, Stainless steel alloy, Cobalt-chromium alloy, Shape memory alloys such as Nitinol (registered trademark), plastic, polymer, Composite material, or Other curing materials A steerable device according to any one of claims 1 to 34, made from at least one of the following.

36. An invasive device comprising a steerable device according to any one of claims 1 to 35.

37. An invasive device comprising a control unit and a steerable device according to any one of claims 1 to 36, wherein the control unit includes a first motor (452) configured to be detachably coupled to the first control tube portion (302a(1,3), 320a).

38. An invasive instrument comprising a control unit and a steerable instrument according to any one of claims 7 to 9, 16 to 23, 25, or 26, wherein the control unit comprises a first motor (452) and a second motor (454), the first motor (452) being configured to be detachably coupled to a first control tube portion (302a (1, 3), 320a), and the second motor (454) being configured to be detachably coupled to a second control tube portion (302a (2, 4), 324a).

39. An invasive device comprising a manually operable control unit and a steerable device according to claim 19 or 20, wherein the manually operable control unit is configured to allow a user to manually move the connecting component (359) both longitudinally and tangentially with their fingers.

40. An invasive device comprising a manually operable control unit and a steerable device according to claim 21 or 22, wherein the manually operable control unit is configured to allow a user to manually move the drive element (359) both longitudinally and tangentially with their fingers.

41. The invasive device according to claim 39 or 40, wherein the manually operable control unit is detachably coupled to the steerable device.

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