Steering device with hinges having a slotted structure

Abstract

To provide a cylindrical element provided with a hinge having a slotted structure optimized for bendability.SOLUTION: A cylindrical element with a hinge structure has: a first portion 524; 522(n-1); a second portion 522(1); 522(n) which is rotatable relative to the first portion, about two rotation sections 530(1); 530(n) arranged at locations rotated 180° relative to each other viewed in a tangential direction of the cylindrical element; and an attachment element. The rotation sections are implemented by being provided with an opening accommodating a pin, being attached to a portion of the attachment element and being attached to another portion of the attachment element, such that the first portion and the second portion cannot move relative to each other in a longitudinal direction, tangential direction, or radial direction but are configured to rotate relative to each other about a center of rotation.SELECTED DRAWING: Figure 9c

Description

Technical Field

[0001]

[0001] The present invention relates to a steerable instrument for endoscopic and / or invasive applications, such as in surgery. The steerable instrument according to the present invention can be used in both medical and non-medical applications. Examples of the latter include inspection and / or repair of mechanical hardware and / or electronic hardware in difficult-to-reach locations. Therefore, terms used in the following description, such as endoscopic applications or invasive instruments, need to be interpreted broadly.

Background Art

[0002]

[0002] The transition from surgical interventions that require large incisions to expose the target area to minimally invasive surgical interventions, i.e., surgical interventions that require only natural openings or small incisions to establish access to the target area, is a well-known and ongoing process. When performing minimally invasive surgical interventions, an operator, such as a physician, requires an access device configured to insert and guide an invasive instrument into the human or animal body through an access port of the body. To reduce scar tissue formation and pain in human or animal patients, the access port is preferably provided by a single small incision in the skin and subcutaneous tissue. From this point, the possibility of using natural openings in the body is even higher. Further, the access device enables the operator to control, preferably, one or more degrees of freedom provided by the invasive instrument. In this way, the operator can perform the necessary measures in the target area within the human or animal body ergonomically and accurately while reducing the risk of the instrument used colliding.

[0003]

[0003] Surgical invasive instruments and endoscopes that guide these instruments toward a target area are well known in the art. Both invasive instruments and endoscopes may have steerable tubes that enhance their navigation and steering capabilities. Such steerable tubes preferably have a proximal end including at least one flexible zone, a distal end including at least one flexible zone, and a rigid or flexible intermediate section, and the steerable tube further includes a steering configuration configured to convert a deflection of at least a portion of the proximal end relative to the rigid intermediate section into a corresponding deflection of at least a portion of the distal end.

[0004]

[0004] Furthermore, the steerable tube preferably comprises several coaxially arranged cylindrical elements, including an outer element, an inner element, and one or more intermediate elements, the number of these one or more intermediate elements depending on the number of flexible zones at the proximal and distal ends of the tube, and the desired realization of the steering members of the steering structure, i.e., whether all steering members can be located within a single intermediate element, or whether the steering members are divided into different sets and each set of steering members is located in a different intermediate element. Furthermore, the steering members can be divided into sub-parts located in different intermediate elements. In most prior art devices, the steering structure comprises, for example, a conventional steering cable with a diameter of 1 mm or less as the steering member, the steering cable located between the relevant flexible zones at the proximal and distal ends of the tube. However, steering cables may have drawbacks in certain applications. Therefore, it may be preferable to avoid them and realize the steering member by one or more sets of longitudinal elements that form an integrated component of one or more intermediate elements. Each intermediate element can be manufactured by using a suitable material addition technique such as injection molding or plating, or by starting with a cylindrical element and then using a suitable material removal technique such as laser cutting, photochemical etching, or deep pressing, a conventional chipping technique such as drilling or milling, or a high-pressure waterjet cutting system. Of the material removal techniques described above, laser cutting is particularly advantageous because it allows for very precise and clean removal of the material under reasonable economic conditions. Further details relating to the design and manufacture of the steerable tube and its steering components described above are, for example, described in WO2009 / 112060A1, WO2009 / 127236A1, US13 / 160,949, and US13 / 548,935 by the present applicant, all of which are incorporated herein by reference in their entirety. The hinges of the present invention are applicable to all components described in these patent documents. Furthermore, the hinges of the present invention are equally applicable to equipment having "classic" cables or wires.

[0005]

[0005] Steerable invasive devices typically include a handle located at the proximal end of a steerable tube for steering the tube and / or operating an instrument located at the distal end of the steerable tube. Such instruments may be, for example, a camera, a manual manipulator such as scissors or forceps, or a manipulator that uses an energy source such as electricity, ultrasound, or light energy source. The instrument may also be a catheter.

[0006]

[0006] In this application, the terms “proximal” and “distal” are defined with respect to the operator, for example, a physician operating the instrument or endoscope. For example, the proximal end should be interpreted as the part located near the physician, and the distal end as the part located away from the physician.

[0007]

[0007] In these steerable devices, the longitudinal elements (or steering wires or cables) need to be flexible in at least a portion of the device so as to allow them to bend relative to the longitudinal axis of the device at both the proximal and distal ends. These longitudinal elements are often located between adjacent outer cylindrical elements and adjacent inner cylindrical elements. When these flexible zones of the device are bent, in each similar zone, these longitudinal elements bend together with the bendable portions of the outer cylindrical elements and inner cylindrical elements.

[0008]

[0008] The flexible zone within the cylindrical element can be realized by a hinge manufactured as a slotted structure within the cylindrical element. Such slots can be created by laser cutting or water cutting of the cylindrical element. There is a continuous desire to optimize such hinges with respect to flexibility (i.e., bending ability), resistance to elasticity in the longitudinal direction of the cylindrical element (longitudinal stiffness), and resistance to elasticity in the tangential direction of the cylindrical element (tangential stiffness). There is a particular need for hinges that give the cylindrical element a bending ability of more than 90° along the shortest possible longitudinal portion of the cylindrical element without the hinge going outside its elastic range. More specific background regarding the hinge is as follows.

[0009]

[0009] In the steerable equipment described in WO2009 / 112060 and WO2009 / 127236, the flexible sections in the inner and outer layers require some kind of hinge and / or elastic structure to provide the bendability of these sections. Preferably, bending of these sections requires minimal force and friction, but the flexible sections should have sufficient longitudinal and torsional (rotational) strength to provide robust handling and operating performance. Another requirement is that, after the required geometric shapes and features of these layers have been manufactured, the processed tubes should still be one piece and straight for further handling, alignment, and equipment assembly processes.

[0010]

[0010] Hinges can be formed from small elements of a material that can be easily bent by elastic deformation and that keep the processed tube in a single, straight shape, as shown in, for example, WO2009 / 112060, WO2009 / 127236, and WO2018 / 067004. A disadvantage of these types of hinges is that the flexibility is limited because it is desirable to keep the deformation of the hinge elements elastic rather than plastic. Plastic deformation would result in a very short fatigue life of the hinge, in which case the structural integrity of the device may only be maintained for a small number of deflections in the bendable zone. Another disadvantage is that a relatively large force is required to elastically bend the hinge material, and it is necessary to use a strong tensile wire to prevent deflection loss due to the elastic stretching of the tensile wire.

[0011]

[0011] The hinge can also be formed by cutting an actual hinge in which a circularly formed hinge element can rotate freely within a corresponding recess. To prevent the tube from falling apart after processing, the shape of this hinge must be such that the circular element is surrounded by the corresponding recess by more than 180 degrees, thereby providing longitudinal integrity. However, the hinge can still separate by sliding along the hinge axis itself (perpendicular to the longitudinal axis of the tube), and therefore the processed tube can still fall apart into separate parts. Also, after processing, tubes with these hinges do not remain straight after processing, but are very flexible and easily bend. This makes further handling, alignment, and equipment assembly difficult. These hinges are illustrated, for example, in Figure 5A of the non-prior publication Dutch patent application NL2021823. To maintain the flexibility of the pipe after processing and prevent separation of parts along the hinge axis, very small, easily bendable elastic bridges can be incorporated into these hinges, as described in Figures 16B and 18 of NL2021823. Alternatively, as described in WO2016089202, detachable fixtures can be applied to such hinges to keep the pipe intact and straight after processing. This combination of a “true” hinge with a detachable fixture is shown in Figure 16A of NL2021823. A major drawback of this “true” hinge, as can be seen in Figure 10 of NL2021823, is that the deflection is strongly limited by the hinge's geometric shape itself, which can be problematic when the overall size of the hinge structure needs to be kept within acceptable limits. Another drawback when combined with elastically deformable elements is that bending forces may increase.

[0012]

[0012] WO2008 / 139768A1, US2009 / 0124857A1, WO2004 / 103430A2, and US2006 / 0199999A1 describe equipment in which multiple cylindrical sections are arranged along a cylindrical axis to form a cylindrical element. Hinges are realized by lugs or similar structures provided at the ends of the cylindrical sections, and the cylindrical sections are arranged such that these lugs or similar structures overlap radially, so that pins can be inserted into the openings of the lugs to form a hinge. However, these arrangements do not satisfy the requirements described herein, namely that the processed tubes should still be a single unit and straight for further handling, alignment, and equipment assembly processes. Furthermore, these arrangements require multiple individual cylindrical sections to be brought together and aligned in order to assemble a single cylindrical or tubular element, leading to complex assembly procedures. Furthermore, after assembly, these hinged tubes do not remain straight but are highly flexible and easily bent. This makes further handling and equipment assembly difficult, including coaxial alignment with further tubular elements. [Overview of the project]

[0013]

[0013] An object of the present invention is to provide a cylindrical element having a hinge with a slotted structure optimized with respect to bendability. In one embodiment, it is also an object to provide a steerable device for endoscopy and / or invasive applications having such a hinge.

[0014]

[0014] This is achieved by the cylindrical element described in claim 1.

[0015]

[0015] The cylindrical element can be manufactured by the method described in the independent claim of the method.

[0016]

[0016] Embodiments of the present invention are described in the dependent claims.

[0017]

[0017] The cylindrical element having the hinge described in the claim improves bendability. The device described in the claim has a strong "true" hinge, which allows for high deflection as several parts can rotate freely relative to each other, and does not have fatigue life limitations or high bending forces.

[0018]

[0018] Herein, the present invention will be described in detail with reference to the “cylindrical” element. However, it should be understood that “cylindrical” is not limited to a circular cross-section. Any other suitable cross-section, including elliptical, rectangular, etc., may be applied.

[0019]

[0019] Further features and advantages of the present invention will become apparent from the description of the invention by 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 forms and equivalent embodiments of the present invention can be conceived and implemented without departing from the scope of the invention. Embodiments of the present invention will be described with reference to the drawings of the accompanying drawings, where similar or identical reference numerals indicate similar, identical or corresponding parts. [Brief explanation of the drawing]

[0020] [Figure 1]

[0020] A schematic perspective view of an invasive device assembly having two steerable devices is shown. [Figure 2a]

[0021] A side view of a non-limiting embodiment of a steerable invasive device is shown. [Figure 2b]

[0022] Detailed perspective views of non-limiting embodiments of elongated tubular bodies of steerable devices are provided. [Figure 2c]

[0023] Figure 2b provides a more detailed view of the distal end of the elongated tubular body shown. [Figure 2d]

[0024] Figure 2b shows a longitudinal cross-sectional view of the elongated tubular body of the steerable device. [Figure 2e]

[0025] A longitudinal cross-sectional view of an elongated tubular body of a steerable device as shown in FIG. 2b, in which the first proximal flexible zone and the first distal flexible zone are bent, is shown, illustrating the operation of the steering configuration. [Figure 2f]

[0026] A longitudinal cross-sectional view of an elongated tubular body of a steerable device as shown in FIG. 2e, in which additionally the second proximal flexible zone and the second distal flexible zone are bent, is shown, further illustrating the operation of the steering configuration. [Figure 2g]

[0027] A longitudinal cross-sectional view of an exemplary embodiment of a steerable device having one proximal flexible zone and one distal flexible zone is shown. [Figure 2h]

[0028] A perspective exploded view of three cylindrical elements of a steerable device as shown in FIG. 2g is shown. [Figure 2i]

[0029] An expanded top view of an exemplary embodiment of an intermediate cylindrical element of a steerable device as shown in FIG. 2h is shown. The intermediate cylindrical element can be formed by winding the expanded shape into a cylindrical configuration and attaching adjacent sides of the wound configuration by any known attachment means such as welding techniques. [Figure 3]

[0030] A perspective view of a part of the elongated tubular body as shown in FIG. 2b is shown, in which the outer cylindrical element is partially removed, and an exemplary embodiment of a longitudinal steering element obtained after providing a longitudinal slit in the wall of an intermediate cylindrical element that interconnects the first proximal flexible zone and the first distal flexible zone of the elongated tubular body is shown. [Figure 4]

[0031] A 3D view of an exemplary embodiment of the present invention is shown. [Figure 5a]

[0032] A hinge structure according to an embodiment of the present invention is shown. [Figure 5b] A hinge structure according to an embodiment of the present invention is shown. [Figure 5c] A hinge structure according to an embodiment of the present invention is shown. [Figure 5d] A hinge structure according to an embodiment of the present invention is shown. [Figure 6]

[0033] A schematic cross-sectional view of a portion of a hinge structure according to one embodiment is shown. [Figure 7]

[0034] A schematic cross-sectional view of a portion of a hinge structure is shown as a further example. [Figure 8a]

[0035] This shows a hinge structure according to another embodiment of the present invention. [Figure 8b] This shows a hinge structure according to another embodiment of the present invention. [Figure 8c] This shows a hinge structure according to another embodiment of the present invention. [Figure 9a]

[0036] This shows a hinge structure according to another embodiment of the present invention. [Figure 9b] This shows a hinge structure according to another embodiment of the present invention. [Figure 9c] This shows a hinge structure according to another embodiment of the present invention. [Figure 10a]

[0037] This shows a hinge structure that, when combined with the structure in Figure 9a, forms another embodiment of the present invention. [Figure 10b] This shows a hinge structure that, when combined with the structure in Figure 9a, forms another embodiment of the present invention. [Figure 11]

[0038] This shows a hinge structure according to another embodiment of the present invention. [Modes for carrying out the invention]

[0021]

[0039] Figure 2a shows a non-limiting embodiment of the steerable invasive device 10. Figure 1 shows a non-limiting embodiment of an invasive device assembly 1 having an introducer with two such steerable invasive devices 10. Details of the steerable invasive device 10 will be described in relation to Figures 2b to 2j.

[0022]

[0040] Figure 2a shows a side view of the steerable invasive device 10. The steerable device 10 comprises an elongated tubular body 18 having a proximal end 11 containing two working flexible zones 14, 15, a distal end 13 containing two distal flexible zones 16, 17, and an intermediate section 12. Here, the intermediate section 12 is shown as rigid. However, in certain applications, the intermediate section 12 may be flexible, as will be described in detail below. In this embodiment, the working flexible zones 14, 15 are configured as flexible proximal zones and are further referred to as flexible proximal zones. These flexible proximal zones 14, 15 are connected to the distal flexible zones by suitable longitudinal elements (not shown in Figure 2a). Alternatively, the flexible proximal zones may be connected to the distal flexible zones by steering cables, as is known in the prior art. As will be explained in detail below, by bending one of these proximal flexible zones 14, 15, the corresponding distal flexible zone also bends.

[0023]

[0041] As described above, the intermediate section 12 may be flexible. This can be achieved by one or more flexible zones. However, these flexible zones are merely flexible, and their bending is not controlled by other flexible zones. If desired, three or more steerable flexible distal zones may be provided. An instrument such as forceps 2 is positioned at the distal end 13. A handle 3 is positioned at the proximal end 11, which is configured to open and close, for example, the jaws of the forceps 2, via a suitable operating cable (not shown) located within the instrument. Cable arrangements for doing so are well known in the art. As is known to those skilled in the art, other instruments may be provided at the distal end.

[0024]

[0042] Figure 2b provides a detailed perspective view of the distal portion of the elongated tubular body 18 of the steerable device 10, showing that the elongated tubular body 18 comprises several coaxially arranged layers or cylindrical elements, including an outer cylindrical element 104 which is the aft end of the first distal flexible zone 16 at the distal end portion 13. The distal end portion 13 of the outer cylindrical element 104 is fixedly attached to an adjacent cylindrical element 103 located inside the outer cylindrical element 104, for example, by spot welding at welding spots 100. However, any other suitable attachment method may be used, including any mechanical snap-fit ​​connection or bonding with a suitable adhesive.

[0025]

[0043] Figure 2c provides a more detailed view of the distal end 13, showing that in this embodiment the distal end 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 spot welding at welding spots 100. However, any other preferred 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 be located some distance from these edges, preferably between the edges and the location of the flexible zone 17.

[0026]

[0044] Those skilled in the art will see that the elongated tubular body 18 shown in Figure 2b comprises a total of four cylindrical elements. The elongated tubular body 18 in the embodiment shown in Figure 2b comprises two intermediate cylindrical elements 102 and 103 in which the steering member of the steering structure is located.

[0027]

[0045] The steering structure in the exemplary embodiment of the elongated tubular body 18 shown in Figure 2b comprises two flexible zones 14, 15 at the proximal end 11 of the elongated tubular body 18, two flexible zones 16, 17 at the distal end 13 of the elongated tubular body 18, and a steering member positioned between the corresponding flexible zones at the proximal end 11 and the distal end 13. An exemplary actual arrangement of the steering member is shown in Figure 2d, providing a schematic longitudinal cross-sectional view of the exemplary embodiment of the elongated tubular body 18 shown in Figure 2b.

[0028]

[0046] Figure 2d shows 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.

[0029]

[0047] The inner cylindrical element 101, when viewed along its entire length from the distal end to the proximal end of the device, comprises a rigid ring 111 located at the distal end 13 of the steerable device 10, a first flexible portion 112, a first intermediate rigid portion 113, a second flexible portion 114, a second intermediate rigid portion 115, a third flexible portion 116, a third intermediate rigid portion 117, a fourth flexible portion 118, and a rigid end portion 119 located at the proximal end portion 11 of the steerable device 10.

[0030]

[0048] The first intermediate cylindrical element 102, when viewed along its entire length from the distal end to the proximal end of the device, comprises a rigid ring 121, a first flexible portion 122, a first intermediate rigid portion 123, a second flexible portion 124, a second intermediate rigid portion 125, a third flexible portion 126, a third intermediate rigid portion 127, a fourth flexible portion 128, and a rigid end portion 129. Portions 122, 123, 124, 125, 126, 127, and 128 together form a longitudinal element 120 that can be moved 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, second intermediate rigid portion 125, third flexible portion 126, third intermediate rigid portion 127, fourth flexible portion 128, and rigid end portion 129 of the first intermediate element 102 are aligned with the longitudinal dimensions of the rigid ring 111, first flexible portion 112, first intermediate rigid portion 113, second flexible portion 114, second intermediate rigid portion 115, third flexible portion 116, third intermediate rigid portion 117, fourth flexible portion 118, and rigid end portion 119 of the inner cylindrical element 101, respectively, preferably being approximately equal to and coinciding with these portions. In this description, “approximately equal” means that the same dimensions are equal within a limit of less than 10%, preferably less than 5%.

[0031]

[0049] Similarly, the first intermediate cylindrical element 102 comprises one or more other longitudinal elements, one of which is indicated by reference no. 120a.

[0032]

[0050] The second intermediate cylindrical element 103, when viewed along its entire length from the distal end to the proximal end of the device, comprises a first rigid ring 131, a first flexible portion 132, a second rigid ring 133, a second flexible portion 134, a first intermediate rigid portion 135, a first intermediate flexible portion 136, a second intermediate rigid portion 137, a second intermediate flexible portion 138, and a rigid end portion 139. Portions 133, 134, 135, and 136 together form a longitudinal element 130 that can be moved longitudinally, like a wire. The longitudinal dimensions of the second rigid ring 133 and second flexible portion 134, first intermediate rigid portion 135, first intermediate flexible portion 136, second intermediate rigid portion 137, second intermediate flexible portion 138, and rigid end portion 139 of the second intermediate cylinder 103, together with the first rigid ring 131 and first flexible portion 132 of the second intermediate cylinder 103, are aligned with the longitudinal dimensions of the rigid ring 111, first flexible portion 112, first intermediate rigid portion 113, second flexible portion 114, second intermediate rigid portion 115, third flexible portion 116, third intermediate rigid portion 117, fourth flexible portion 118, and rigid end portion 119 of the first intermediate element 102, respectively, preferably being approximately equal to and coinciding with them.

[0033]

[0051] Similarly, the second intermediate cylindrical element 103 comprises one or more other longitudinal elements, one of which is indicated by reference no. 130a.

[0034]

[0052] The outer cylindrical element 104, when viewed along its entire length from the distal end to the proximal end of the device, comprises a first rigid ring 141, a first flexible portion 142, a first intermediate rigid portion 143, a second flexible portion 144, and a second rigid ring 145. The longitudinal dimensions of the first flexible portion 142, the first intermediate rigid portion 143, and the second flexible portion 144 of the outer cylindrical element 104 are aligned with, preferably substantially equal to, and coincide with, the longitudinal dimensions of the second flexible portion 134, the first intermediate rigid portion 135, and the first intermediate flexible portion 136 of the second intermediate element 103, respectively. The rigid ring 141 has approximately the same length as the rigid ring 133 and is fixedly attached to the rigid ring 133, for example, by spot welding or adhesive. Preferably, the rigid ring 145 overlaps the second intermediate rigid portion 137 only to the extent necessary to provide proper fixed attachment between the rigid ring 145 and the second intermediate rigid portion 137, for example by spot welding or adhesive bonding. The rigid rings 111, 121, and 131 are attached to each other, for example by spot welding or adhesive bonding. This may be done at their edges or at a distance from these edges.

[0035]

[0053] In one embodiment, the same may be applied to rigid end portions 119, 129, and 139, which can also be attached together in an equivalent manner. However, the structure may be such that the diameter of the cylindrical element in the proximal portion is larger or smaller than the diameter in the distal portion. In such embodiments, the structure in the proximal portion differs from that shown in Figure 2d. As a result of the increase or decrease in diameter, amplification or attenuation is achieved, i.e., the bending angle of the flexible zone in the distal portion is greater or smaller than the bending angle of the corresponding flexible portion in the proximal portion.

[0036]

[0054] 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 18, 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, thereby allowing adjacent cylindrical elements to slide against each other. The dimensionality should allow for sliding fit between adjacent elements. The gap between adjacent elements may generally be on the order of 0.02 to 0.1 mm, but depends on the specific application and the material used. The gap is preferably smaller than the wall thickness of the longitudinal elements in order to prevent overlapping configurations of the longitudinal elements. Limiting the gap to approximately 30% to 40% of the wall thickness of the longitudinal element is generally sufficient.

[0037]

[0055] As can be seen in Figure 2d, the flexible zone 14 of the proximal end 11 is connected to the flexible zone 16 of the distal end 13 by portions 134, 135, and 136 of the second intermediate cylindrical element 103, which forms a first set of longitudinal steering members of the steering structure of the steerable device 10. Furthermore, the flexible zone 15 of the proximal end 11 is connected to the flexible zone 17 of the distal end 13 by portions 122, 123, 124, 125, 126, 127, and 128 of the first intermediate cylindrical element 102, which forms a second set of longitudinal steering members of the steering structure. Using the above structure, the steerable device 10 can be used for double bending. The operating principle of this structure will be explained in relation to the example shown in Figures 2e and 2f.

[0038]

[0056] For convenience, as shown in Figures 2d, 2e, and 2f, the various parts of the cylindrical elements 101, 102, 103, and 104 are grouped into zones 151 to 160, defined as follows: Zone 151 comprises rigid rings 111, 121, and 131. Zone 152 comprises parts 112, 122, and 132. Zone 153 comprises rigid rings 133 and 141 and parts 113 and 123. Zone 154 comprises parts 114, 124, 134, and 142. Zone 155 comprises parts 115, 125, 135, and 143. Zone 156 comprises parts 116, 126, 136, and 144. Zone 157 comprises rigid ring 145 and parts 117, 127, and 137 that coincide with it. Zone 158 comprises portions of the outer parts 117, 127, and 137 of Zone 157. Zone 159 comprises portions 118, 128, and 138. Finally, Zone 160 comprises rigid end portions 119, 129, and 139.

[0039]

[0057] To deflect at least a portion of the distal end 13 of the steerable device 10, a bending force can be applied to zone 158 in any radial direction. As shown in the example in Figures 2e and 2f, zone 158 is bent downward relative to zone 155. As a result, zone 156 is bent downward. The downward bend of zone 156 is converted into an upward bend of zone 154 relative to zone 155 by the longitudinal displacement of the first set of steering members, which comprises portions 134, 135, and 136 of a second intermediate cylindrical element 103 positioned between a second intermediate rigid portion 137 and a second rigid ring 133. This is shown in both Figures 2e and 2f.

[0040]

[0058] Note that, as shown in Figure 2e, the exemplary downward bend of zone 156 results in an upward bend of zone 154 only at the distal end of the instrument. The bending of zone 152 as a result of the bending of zone 156 is prevented by zone 153, which is positioned between zones 152 and 154. Subsequently, when a bending force is applied to zone 160 in any radial direction, zone 159 also bends. As shown in Figure 2f, zone 160 is bent upward relative to its position shown in Figure 2e. As a result, zone 159 bends upward. The upward bend of zone 159 is converted into a downward bend of zone 152 relative to its position shown in Figure 2e by the longitudinal displacement of the second set of steering members, which comprises portions 122, 123, 124, 125, 126, 127, and 128 of the first intermediate cylindrical element 102 positioned between the rigid ring 121 and the rigid end portion 129.

[0041]

[0059] Figure 2f further shows that the initial bend of the device in zone 154 shown in Figure 2e is maintained, because, as described above, this bend is governed solely by the bend of zone 156, and the bend of zone 152 is governed solely by the bend of zone 159. The fact that zones 152 and 154 can bend independently of each other makes it possible to give the distal end 13 of the steerable device 10 independent positions and longitudinal axes. Specifically, the distal end 13 can take an advantageous S-shape. Those skilled in the art will understand that the ability to bend zones 152 and 154 independently of each other significantly enhances the operability of the distal end 13, and by extension, the entire steerable device 10.

[0042]

[0060] It is clear that the length of the flexible portion shown in Figures 2d to 2f can be changed to accommodate specific requirements related to the bending radius and overall length of the distal end 13 and proximal end 11 of the steerable device 10, or to accommodate the amplification or attenuation rate between the bending of at least a portion of the proximal end 11 and at least a portion of the bending of the distal end 13.

[0043]

[0061] The steering member comprises one or more sets of longitudinal elements that form an integrated component of one or more intermediate cylindrical elements 102, 103. Preferably, the longitudinal elements comprise the remaining portion of the walls of the intermediate cylindrical elements 102, 103 after longitudinal slits have been provided in the walls of the intermediate cylindrical elements 102, 103, and these longitudinal slits define the remaining longitudinal steering element.

[0044]

[0062] Further details regarding the manufacture of the latter longitudinal steering element are provided with reference to Figures 2g to 2i, which illustrate exemplary embodiments of a steerable device having only one flexible zone at both its proximal end 11 and distal end 13.

[0045]

[0063] Figure 2g shows a longitudinal cross-section of a steerable device 2201 comprising three coaxially arranged cylindrical elements: an inner cylindrical element 2202, an intermediate cylindrical element 2203, and an outer cylindrical element 2204. Suitable materials to be used to fabricate the cylindrical elements 2202, 2203, and 2204 include stainless steel, cobalt-chromium, shape memory alloys such as Nitinol®, plastics, polymers, composites, or other machinable materials. Alternatively, the cylindrical elements can be fabricated by a 3D printing process.

[0046]

[0064] The inner cylindrical element 2202 comprises a first rigid end 2221 located at the distal end 13 of the device 2201, a first flexible portion 2222, an intermediate rigid portion 2223, a second flexible portion 2224, and a second rigid end 2225 located at the proximal end 11 of the device 2201.

[0047]

[0065] The outer cylindrical element 2204 also comprises a first rigid end 2241, a first flexible end 2242, an intermediate rigid end 2243, a second flexible end 2244, and a second rigid end 2245. The lengths of portions 2221, 2222, 2223, 2224, and 2225 of the cylindrical element 2202, and the lengths of portions 2241, 2242, 2243, 2244, and 2245 of the cylindrical element 2204, are preferably substantially the same so that these different portions are aligned longitudinally with one another when the inner cylindrical element 2202 is inserted into the outer cylindrical element 2204.

[0048]

[0066] The intermediate cylindrical element 2203 also has a first rigid end 2331 and a second rigid end 2335, which, in the assembled state, are located between the corresponding rigid parts 2221, 2241 and 2225, 2245 of the two other cylindrical elements 2202, 2204, respectively. The intermediate portion 2333 of the intermediate cylindrical element 2203 comprises three or more separate longitudinal elements, which may have different forms and shapes, as described below. After assembling the three cylindrical elements 2202, 2203, and 2204, inserting element 2202 into element 2203, and inserting the two combined elements 2202 and 2203 into element 2204, at least the first rigid end 2221 of the inner cylindrical element 2202, the first rigid end 2331 of the intermediate cylindrical element 2203, and the first rigid end 2241 of the outer cylindrical element 2204 are attached to each other at the distal end of the device. In the embodiments shown in Figures 2g and 2h, the second rigid end 2225 of the inner cylindrical element 2202, the second rigid end 2335 of the intermediate cylindrical element 2203, and the second rigid end 2245 of the outer cylindrical element 2204 are also attached to each other at the proximal end of the device so that the three cylindrical elements 2202, 2203, and 2204 form a single integrated unit.

[0049]

[0067] In the embodiment shown in Figure 2h, the intermediate portion 2333 of the intermediate cylindrical element 2203 comprises several longitudinal elements 2338 having the same cross-section, and as a result, the intermediate portion 2333 has the overall shape and form as shown in Figure 2i with the intermediate cylindrical element 2203 extended. From Figure 2i, it is also clear that the intermediate portion 2333 is formed by several parallel longitudinal elements 2338 arranged at equal intervals around the circumference of the intermediate cylindrical portion 2203. Advantageously, the number of longitudinal elements 2338 is at least three, but any more is possible, so that the device 2201 is fully controllable in any direction. Preferably, the number of longitudinal elements 2338 is six or eight.

[0050]

[0068] The fabrication of such intermediate sections 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 necessary to ultimately obtain the desired shape of the intermediate cylindrical element 2203. However, alternatively, any 3D printing method can be used.

[0051]

[0069] Material removal can be carried out by various techniques such as laser cutting, photochemical etching, and deep pressing, conventional chipping techniques such as 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 above process is convenient because it allows the member 2203 to be manufactured in essentially one process without requiring additional steps to connect the various parts of the intermediate cylindrical element, as is required in conventional equipment where the steering cable must be connected to the end in some way. The same type of technique can be used to manufacture the inner cylindrical element 2202 and the outer cylindrical element 2204, each having flexible parts 2222, 2224, 2242, and 2244, respectively.

[0052]

[0070] Figure 3 shows an exemplary embodiment of the longitudinal (steering) element 4 obtained after providing a longitudinal slit 5 in the wall of the second intermediate cylindrical element 103 that interconnects the proximal flexible zone 14 and the distal flexible zone 16 as described above. That is, the longitudinal steering element 4 is at least partially helical around the longitudinal axis of the device, and as a result, the end portion of each steering element 4 in the proximal part of the device is arranged in an angular orientation around the longitudinal axis that is different from the end portion of the same longitudinal steering element 4 in the distal part of the device. If the longitudinal steering element 4 were arranged in a linear orientation, bending of the device in the proximal part of a plane would result in bending of the device in the distal part of the same plane but in the opposite direction by 180 degrees. This helical structure of the longitudinal steering element 4 makes it possible for bending of the device in the proximal part of a plane to result in bending of the device in another plane, or in the distal part of the same plane in the same direction. A preferred helical structure is one in which the end portions of each steering element 4 in the proximal part of the device are oriented at an angle of 180 degrees around the longitudinal axis relative to the end portion of the same longitudinal steering element 4 in the distal part of the device. However, any other angled orientation, such as 90 degrees, is within the scope of this document. The slits are dimensioned so that when provided in a given location in the steerable device, the movement of the longitudinal elements is guided by adjacent longitudinal elements.

[0053]

[0071] The flexible portions 112, 132, 114, 142, 116, 144, 118, and 138 shown in Figure 2d, and the flexible portions 2222, 2224, 2242, and 2244 shown in Figures 2g and 2h, can be obtained by the method described in European Patent Application No. 08004373.0 (page 5, lines 15-26), filed on 10 March 2008, but the flexible portions can be manufactured using any other suitable process.

[0054]

[0072] Such a flexible portion may have a structure as shown in Figures 2b and 2c. That is, flexibility can be achieved by a plurality of slits 14a, 15a, 16a, 17a. For example, two circumferential slits may be provided on a cylindrical element along the same circumferential line, and both slits are located at a certain distance from each other. Multiple identical sets of circumferential slits 14a, 15a, 16a, 17a are provided at multiple distances along the longitudinal direction of the device, and consecutive sets are positioned at angularly rotated positions, for example, rotated 90 degrees each time. In such an arrangement, all parts of the cylindrical element are still connected to each other.

[0055]

[0073] Furthermore, as shown in Figure 2d, the above manufacturing method can be used when portions 122, 123, 124, 125, 126, 127, and 128 of the first intermediate cylindrical element 102 and portions 134, 135, and 136 of the second intermediate cylindrical element 103, which form the first and second sets of longitudinal steering members respectively, are realized as longitudinal steering elements 4 as shown in Figure 2h. The same applies to the longitudinal elements 2338 in Figures 2h and 2i. Furthermore, any embodiment described in EP2762058A can be used in accordance with the present invention.

[0056]

[0074] Otherwise, the longitudinal elements 4, 2338 can also be obtained by any other technique known in the art, such as those described in EP1708609A. The only limitation on the structure of the longitudinal elements used in these parts is that the overall flexibility of the device must be maintained at the locations where the flexible parts coincide.

[0057]

[0075] With respect to exemplary embodiments of the steerable device shown in Figures 2d, 2e, and 2f, the different coaxially arranged layers or cylindrical elements 101, 102, 103, 104, 2202, 2203, and 2204 described above can be fabricated by any known method, if they are suitable for fabricating a multilayer system. A multilayer system should be understood as a steerable device comprising at least two separate sets of longitudinal elements 4, 2338 for transmitting movement of the proximal end to the distal end. The assembly of different cylindrical elements can be realized in the same way. A preferred method for fabricating different cylindrical elements is described in EP2762058A above, which is incorporated herein by reference in whole.

[0058]

[0076] In the above embodiment, the proximal and distal portions are similarly structured. However, as will become clear below, this is not necessarily the case.

[0059]

[0077] Figure 4 shows a 3D view of an example of a steerable device. Similar reference numbers refer to the same elements in other figures. Their descriptions are not repeated here. The device comprises five coaxial cylindrical elements 202–210. The inner cylindrical element 210 is surrounded by an intermediate cylindrical element 208, which is surrounded by an intermediate cylindrical element 206, which is surrounded by an intermediate cylindrical element 204, and finally, this intermediate cylindrical element 204 is surrounded by an outer cylindrical element 202. The inner intermediate cylindrical elements may be made from flexible spiral springs. The proximal and distal ends of the device are indicated by reference numbers 226 and 227, respectively.

[0060]

[0078] As shown herein, the device 18 includes a flexible zone 19 in its intermediate portion between the flexible zone 14 and the flexible zone 16. That is, the intermediate cylindrical element 204 (located on the outer surface of the area of ​​the flexible zone 19) is provided with a slotted structure to give the intermediate cylindrical element the desired flexibility. The longitudinal length of the slotted structure in the flexible zone 19 depends on the desired application. It may be the same length as the entire portion between the flexible zones 14 and 16. All other cylindrical elements 206, 208, and 210 inside the intermediate cylindrical element 204 are also flexible in the flexible zone 19. Those cylindrical elements having longitudinal elements in the flexible zone 19 are, by definition, flexible. Others are preferably provided with suitable hinges made by suitable slotted structures.

[0061]

[0079] According to the present invention, at least one of the slotted structures has a special design as described in detail below. This structure may be applied at any position where the device described with reference to the above figures has a hinge.

[0062]

[0080] Figure 5a shows a cylindrical element 500 having a hinge 501 fabricated as a slotted structure. The cylindrical element 500 comprises a portion 504 and a further portion 509 on the opposite side of portion 504. The hinge 501 is located between them.

[0063]

[0081] The hinge 501 comprises a plurality of hinge portions 502(1), 502(2), ... 502(n), ..., 502(N) (where N is an integer greater than 1). In the illustrated example, each hinge portion 502(n) has the same shape, but this is not necessarily required. Each illustrated hinge portion 502(n) is a rigid ring-shaped portion of the cylindrical element 500.

[0064]

[0082] The portion 504 and the hinge portion 502(1) are rotatable relative to each other by two rotatable sections 507(1) (one is visible in Figure 5a), which are positioned 180° rotated relative to each other in the tangential direction of the cylindrical element 500. To this end, the ring-shaped portion 502(1) is provided with two extensions 506(1) (only one is visible in Figure 5a) which are positioned 180° opposite to each other when viewed tangentially to the cylindrical element 500. That is, the two rotatable sections 507(1) and the two associated extensions 506(1) are located in the same position along the central axis 500c (cylinder axis), and the lines connecting the two rotatable sections and the two extensions intersect the central axis at a right angle. Each extension 506(1) has a circular outer edge oriented toward the portion 504. Section 504 is provided with two notches 505(1) (only one is visible in Figure 5a) that are 180° opposite each other when viewed tangentially to the cylindrical element 500. Each notch 505(1) has a circular inner edge with a radius equal to or slightly larger than the circular outer edge of the extension 506(1) so that the extension 506(1) can rotate within the notch 505(1). Each notch 505(1) accommodates one extension 506(1).

[0065]

[0083] Preferably, the extension 506(1) and the notch 505(1) are manufactured by cutting a circular slot into the cylindrical element 500, for example, by laser cutting or water cutting. Any other cutting technique may be used instead. In one example, the cutting process is carried out such that the slot is interrupted by a small bridge 510(1), as a result the extension 506(1) and the notch 505(1) are still attached to each other. These bridges act as “breaking elements” as described in detail in patent application WO2016 / 089202A1 and non-prior publication patent application PCT / NL2019 / 050680. These bridges or breaking elements are intentionally manufactured when the cylindrical element and the device are manufactured, but are intentionally made weak enough to break if a force above a certain threshold is applied to them. Here, they are designed to break when the portion 504 and the hinge portion 502(1) are rotated relative to each other about the two extensions 506(1) with at least such a threshold force, as indicated by the double arrow 503. The threshold force is selected such that the bridge 510(1) breaks before either the portion 504 or the hinge portion 502(1) deforms beyond its maximum elasticity due to the applied rotational force. As will be explained below, they only break later in the manufacturing process. Before breaking, the breaking element, e.g., the bridge 510(1), provides the cylindrical element with a certain additional stiffness, thereby making it easier to manipulate the cylindrical element when inserting it into another cylindrical element or inserting another cylindrical element into its own. Once broken, the breaking element no longer serves a purpose, and the extension 506(1) can rotate within the notch 505(1).

[0066]

[0084] Such fracture elements can be fabricated as follows: Slots are created, for example, by directing a laser beam or water beam having a predetermined energy and width into a cylindrical element so as to cut through the entire thickness of the cylindrical element. The laser beam is moved relative to the outer surface of the cylindrical element by moving the laser source relative to the outer surface of the cylindrical element. However, at the location where the fracture element will be formed, the laser beam is interrupted for a certain period of time, but the laser source continues to move relative to the outer surface of the cylindrical element.

[0067]

[0085] As described above, when the various parts of the slotted structure are initially deflected relative to each other, these fracture elements will break. A major advantage of such fracture elements is that, after fracture, the distance between the two opposing sides of the fracture element is virtually 0 μm, resulting in extremely small play between them.

[0068]

[0086] These types of fracture elements can be applied between any elements or parts of the equipment and cylindrical elements described herein, formed by laser cutting.

[0069]

[0087] Fracture elements should be designed in the following manner: Before fracture, each fracture element is attached to an opposing portion of a cylindrical element. These opposing portions of the cylindrical element each have a yield stress value that, if exceeded, will cause permanent deformation of those portions. Furthermore, each fracture element has a fracture tensile stress value that defines the force applied to cause the fracture element to break. The tensile stress value of each fracture element should be lower than the yield stress values ​​of these opposing portions of the cylindrical element. For example, the tensile stress value of each fracture element is in the range of 1% to 80% of the yield stress of these portions of the cylindrical element. Alternatively, this range may be 1% to 50%.

[0070]

[0088] The portion 504 is provided with an outer edge portion 514 facing the outer edge portion 512 of the hinge portion 502(1). The outer edge portions 514 and 512 define an open space between them, and therefore, once the bridge 510(1) is damaged, the portion 504 and the hinge portion 502(1) can rotate freely relative to each other about the extension portion 506(1) to a predetermined bending angle reached when the outer edges portions 514 and 512 come into contact with each other.

[0071]

[0089] The outer edges 514 and 512 result from cuts into the cylindrical element 500, such as laser cutting or water cutting. All adjacent hinge portions 502(n), 502(n+1) have open spaces between them, such as the space defined between portion 504 and hinge portion 502(1), which result from cutting processes, such as laser cutting or water cutting. These spaces are rotated alternately by 90° when viewed tangentially to the cylindrical element 500.

[0072]

[0090] The hinge portion 502(1) has a further outer edge portion 515 facing the outer edge portion 517 of the hinge portion 502(2). The outer edge portion 515 is provided with two circular notches 505(2) (one is visible in Figure 5a) that are 180° opposite each other when viewed tangentially to the cylindrical element 500. Each circular notch 505(2) accommodates a circular extension portion 506(2) of the hinge portion 502(2). Each combination of notch 505(2) and extension portion 506(2) is rotated 90° relative to the combination of notch 505(1) and extension portion 506(1). Similar to the combination of notch 505(1) and extension 506(1), the combination of notch 505(2) and extension 506(2) is produced, in one example, by cutting a circular slot into the cylindrical element 500, for example, by laser cutting or water cutting. Any other cutting technique may be used instead. In one example, the cutting is performed such that the slot is interrupted by a smaller bridge 510(2) similar to bridge 510(1), so that the extension 506(2) and notch 505(2) are still attached to each other. These bridges also function as “breaking elements” as described above.

[0073]

[0091] The consecutive pairs of rotatable sections 507(n) and 507(n+1) are rotated approximately 90° relative to each other when viewed tangentially to the cylindrical element 500, so that hinge portion 502(n-1) and hinge portion 502(n) can rotate relative to each other in a first direction, which is perpendicular to a second direction of rotation of hinge portion 502(n) relative to hinge portion 502(n+1). As shown in the figure, the directions of rotation between consecutive hinge portions alternate between the first and second directions, so that the hinge 501 is flexible in all directions.

[0074]

[0092] In one example, each notch 505(n) is still attached to the housing extension 506(n) by a bridge similar to or identical to bridge 510(1) when a slot is created between the notch 505(n) and the extension 506(n). Thus, in such an example, after the cylindrical element structure 500 of Figure 5a is fabricated, all adjacent parts and hinge parts are still attached to each other, and the structure does not break down into separate parts. Thus, when ready, the cylindrical element structure 500 of Figure 5a can be inserted as a single unit into the cylindrical element structure 520 shown in Figure 5b. This cylindrical element 520 can also be fabricated as a single element in which all various parts and hinge parts are still attached to each other by a breaking element before the entire hinge structure is used for bending motion.

[0075]

[0093] Figure 5b shows the cylindrical element 520 in detail.

[0076]

[0094] Figure 5b shows a cylindrical element 520 having a hinge 521 fabricated as a slotted structure. The cylindrical element 520 comprises a portion 524 and a further portion 529 on the opposite side of portion 524. The hinge 521 is located between them.

[0077]

[0095] The hinge 521 comprises a plurality of hinge portions 522(1), 522(2), ... 522(n), ..., 522(N) (where N is an integer greater than 1). In the illustrated example, each hinge portion 522(n) has the same shape, but this is not necessarily required. Each illustrated hinge portion 522(n) is a rigid ring-shaped portion of a cylindrical element 520.

[0078]

[0096] The portion 524 and the hinge portion 522(1) are arranged to be rotatable relative to each other by two rotatable sections 530(1) (only one is visible in Figure 5b), the two rotatable sections 530(1) being positioned 180° rotated relative to each other when viewed tangentially to the cylindrical element 521. One such rotatable section 530, indicated by the dotted circle Vd in Figure 5b, is shown in detail in Figure 5d. Similar to the rotatable section 507(1) of the cylindrical element 500 described above, the line connecting the two rotatable sections 530(1) intersects perpendicularly with the central axis 520c of the hinge 521. Thus, the portion 524 and the hinge portion 522(1) are rotatable about this line.

[0079]

[0097] As shown in Figure 5d, the rotatable section 530(1) includes an extension 548(1) having a circular outer edge. This extension 548(1) may also be called the first rotatable section portion. This circular extension 548(1) is housed within a circular notch 550(1) of the hinge portion 522(1). The circular notch may also be called the second rotatable portion, or may form part of the second rotatable section portion, which includes the region of the hinge portion 522(1) facing portion 524. The radius of the circular extension 548(1) and the radius of the circular notch 550(1) are the same. They have the same center of rotation. The circular extension 548(1) and the circular notch 550(1) are separated by a small slot created by a cutting operation, e.g., laser or water cutting, or any other suitable cutting technique. During the fabrication of the slot, the slot is interrupted in place, and thus the extension 548(1) and notch 550(1) are still attached to each other by one or more small bridges 552(1). These bridges 552(1) act as “breaking elements” as defined above; that is, they break when a force exceeding a certain threshold is applied. Here, they are designed to break when the portion 524 and hinge portion 522(1) are rotated relative to each other about the two extensions 548(1) by at least such a threshold force. The threshold force is selected such that the bridges 552(1) break before either the portion 524 or the hinge portion 522(1) deforms beyond its maximum elasticity due to the applied rotational force. As will be described below, they only break later in the fabrication process.

[0080]

[0098] The extension 548(1) is provided with a circular slot 542(1) centered on its rotational center. The radius of the slot 542(1) is smaller than the radius of the circular extension 548(1) itself. Inside the slot 542(1) remains a circular island 556(1). As will become apparent below in this specification, this island 556(1) forms an element that may also be called a pin in a hinge or a rotatable disc. Thus, in the context of the present invention, a pin is defined as an element that is inserted into an opening of another element, and this other element can rotate about the pin. During the manufacture of the slot 542(1), the slot 542(1) is interrupted by a small bridge 540(1) thereby keeping the circular island 556(1) attached to the rest of the extension 548(1). These bridges 540(1) act as “breaking elements” as defined above; that is, they break when a force exceeding a certain threshold is applied. Here, they are designed to break when the circular island 556(1) and the extension 548(1) are rotated relative to each other by at least such a threshold force. The threshold force is selected such that the bridge 540(1) breaks before either the extension 548(1) or the circular island 556(1) deforms beyond its maximum elasticity due to the applied rotational force. As described below, they only break later in the manufacturing process.

[0081]

[0099] Reference numeral 544(1) refers to a mounting structure within the circular island 556(1). The mounting structure 544(1) is positioned so that the circular island 556(1) can be attached to the circular extension 506(1) of the cylindrical element 500 after the cylindrical element 500 has been inserted into the cylindrical element 520. Such attachment can be performed by any preferred attachment technique, including bonding, soldering, welding, and laser welding. To assist laser welding, the mounting structure 544(1) may be formed, for example, as a small S-shaped slotted structure made by laser cutting or water cutting.

[0082]

[0100] The hinge portion 522(1) may be provided with one or more lips 554(1) (one is shown in Figures 5b and 5d). Such lips 554(1) may be located adjacent to the rotatable section 530(1) at substantially the same tangential position as the circular island 556(1). The lips 554(1) are used to attach the hinge portion 522(1) of the cylindrical tube 520 to the hinge portion 502(1) of the cylindrical element 500, for example, by welding or laser welding, after the cylindrical element 500 has been inserted into the cylindrical element 520.

[0083]

[0101] Referring again to Figure 5b, the hinge portion 522(1) and hinge portion 522(2) are arranged to rotate relative to each other about two rotatable sections 530(2) (only one is shown in Figure 5b), and these two rotatable sections 530(2) are positioned rotated 180° relative to each other when viewed tangentially to the cylindrical element 520. The structure of the rotatable section 530(2) is preferably identical to that of the rotatable section 530(1). Thus, the rotatable section 530(2) preferably has the same elements as the rotatable section 530(1) shown in Figure 5d, where all indices (1) are replaced by (2). The rotatable section 530(2) is positioned rotated 90° relative to the position of the rotatable section 530(1) when viewed tangentially to the cylindrical element 520.

[0084]

[0102] In more general terms, the rotation mechanism between two adjacent hinge portions 522(n) and 522(n+1) is as follows: The hinge portions 522(n) and 522(n+1) are arranged to rotate relative to each other about two rotatable sections 530(n+1), which are rotated 180° relative to each other when viewed tangentially to the cylindrical element 520. The structure of the rotatable section 530(n+1) is preferably identical to that of the rotatable section 530(1). Thus, the rotatable section 530(n+1) has the same elements as the rotatable section 530(1) shown in Figure 5d, where all exponents (1) are replaced by (n+1). The rotatable section 530(n+1) is located at a position rotated 90° relative to the positions of the rotatable sections 530(n) and 530(n+2) when viewed tangentially to the cylindrical element 520. Preferably, the rotatable sections 530(n) and 530(n+2) are identical to the rotatable section 530(1).

[0085]

[0103] The portion 524 is provided with an outer edge portion 526 facing the outer edge portion 528 of the hinge portion 522(1). The outer edges 526 and 528 define an open space between them, and therefore, once the bridge 552(1) is damaged, the portion 524 and the hinge portion 522(1) can rotate freely relative to each other about the extension portion 548(1) to a predetermined bending angle reached when the outer edges 526 and 528 come into contact with each other.

[0086]

[0104] The outer edges 526 and 528 are formed by cutting a predetermined pattern into the cylindrical element 520, for example, by laser cutting or water cutting. All adjacent hinge portions 522(n), 522(n+1) have open spaces between them, such as the space defined between portion 524 and hinge portion 522(1), which are formed by cutting, for example, by laser cutting or water cutting. These spaces are rotated alternately by 90° when viewed tangentially to the cylindrical element 520.

[0087]

[0105] Since the consecutive rotatable sections 530(n) and 530(n+1) are rotated approximately 90° relative to each other when viewed tangentially to the cylindrical element 520, the hinge portion 522(n-1) and hinge portion 522(n) rotate relative to each other in a first direction, which is perpendicular to the second direction of rotation of hinge portion 522(n) relative to hinge portion 522(n+1). As shown in the figure, the rotational directions between the consecutive hinge portions alternate between the first and second directions, so that the hinge 521 is flexible in all directions.

[0088]

[0106] In one example, each notch 550(n) is still attached to the extension 548(n) by the bridge 552(n) when a slot is created between the notch 550(n) and the extension 548(n). Therefore, after the cylindrical element structure 520 in Figure 5b is fabricated, in such an example all the various parts are still attached to each other and the structure does not break down into separate parts. Furthermore, after the cylindrical element 520 is fabricated, all the circular islands 556(n) are also still attached to the surrounding circular extension 548(n) by the bridge 540(n). Therefore, when ready, the cylindrical element structure 520 in Figure 5b is still a single unit when ready to insert the cylindrical element 500 into the cylindrical element structure 520. Furthermore, before being inserted into each other, both cylindrical elements 500 and 520 still have a linear structure due to all the bridges 510(n) and 552(n), which facilitates the operation of inserting the two cylindrical elements 500 and 520 into each other.

[0089]

[0107] Bridges 552(1) and 540(1) are designed as “fracture elements” as described herein; that is, they break when a predetermined force is applied that is less than the force required to deform the surrounding material beyond its maximum elasticity.

[0090]

[0108] Figure 5c shows the resulting hinge structure when the cylindrical elements 500 and 520 are inserted into each other. As shown in the figure, in the assembled state, the cylindrical elements 500 and 520 are aligned with each other both longitudinally and tangentially such that each rotatable section 530(n) of cylindrical element 520 aligns with one rotatable section 507(n) of cylindrical element 500. To complete the assembly, after inserting cylindrical element 500 into cylindrical element 520, each mounting structure 544(n) is attached to one circular extension 506(n) by, for example, adhesive, soldering, welding, or laser welding. Optionally, one or more hinge portions 522(n) are also attached to hinge portion 502(n) by, for example, adhesive, soldering, welding, or laser welding the lip 554(n) to the hinge portion 502(n). This latter action imparts greater rigidity to the entire hinge structure.

[0091]

[0109] Part 529 can be attached to part 509 in a similar manner, for example, by bonding, soldering, welding, or laser welding the lip 534 to part 509, or by any other preferred method. Similarly, parts 504 and 524 can be attached to each other.

[0092]

[0110] After the cylindrical elements 500 and 520 are mounted to each other in this manner, the user can apply a rotational force in the direction indicated by the double arrow 503 in Figure 5a. When the rotational force exceeds a certain threshold, all the breaking elements 510(n), 540(n), and 552(n) break. As a result, parts 504 / 524 can rotate freely around pin 556(1) relative to adjacent hinge parts 502(1) / 522(1), and hinge parts 502(n) / 522(n) can rotate freely around pin 556(n+1) relative to adjacent hinge parts 502(n+1) / 522(n+1). Similarly, parts 509 / 529 can rotate freely relative to hinge parts 502(N) / 522(N).

[0093]

[0111] Furthermore, each circular island 556(n) is securely attached to a circular extension 506(n) within the cylindrical element 500 and can rotate freely with the circular extension 506(n) within the extension 548(n) of the cylindrical element 520. This structure allows the circular island 556(n) to act as a pin or spindle with two functions. First, it acts as a pivot pin that is the center of rotation for the extension 548(n). Second, because the slot between the pin 556(n) and the extension 548(n) can be made very narrow, the pin 556(n) acts to keep the hinge portions 502(n) / 522(n) and adjacent hinge portions 502(n+1) / 522(n+1) in clearly defined positions relative to each other with little play between them. The same applies to the position of part 504 / 524 relative to hinge part 502(1) / 522(1) and the position of hinge part 502(N) / 522(N) relative to part 509 / 529.

[0094]

[0112] Figure 6 shows a schematic cross-sectional view of an extension 506(n) of a cylindrical element 500 and how such an extension 506(n) is attached to a pin 556(n), which is rotatably positioned in a hole in the extension 548(n) within the cylindrical element 520, defined by a slot 542(n). The pin 556(n) is attached to the extension 506(n) by, for example, (laser) welding a mounting structure 544(n) to the extension 506(n). Since the structure is rotationally symmetric, the cylindrical element 500 has two such pins 556(n) on either side of its axis of symmetry 500c (and thus rotated 180° when viewed tangentially), both of which are housed in holes defined by a slot 542(n) within the extension 548(1) of the cylindrical element 520. This provides a robust structure in which adjacent parts of the hinge structure are connected to each other yet can rotate freely relative to each other. It should also be noted that the adjacent hinge parts 502(n) / 522(n) and 502(n+1) / 522(n+1) are no longer attached to each other by any part of either the cylindrical element 500 or the cylindrical element 520. Therefore, there is no elastic deformation of the material that would generate a counter-rotational force during rotation.

[0095]

[0113] Figure 7 shows that pins 556(n) can be further attached to the extension portion 848(n) of the cylindrical element 820 that surrounds the cylindrical element 520 shown in Figures 8a and 8b. This can be done by bonding, soldering, welding, or laser welding the extension portion 848(n) to the pin 556(n) using the mounting structure 844(n).

[0096]

[0114] Figure 8a shows the cylindrical element 820 in more detail.

[0097]

[0115] Figure 8a shows a cylindrical element 820 having a hinge 821 fabricated as a slotted structure. The cylindrical element 820 comprises a portion 824 and a further portion 829 on the opposite side of portion 824. The hinge 821 is located between them.

[0098]

[0116] The hinge 821 comprises a plurality of hinge portions 822(1), 822(2), ...822(n), ..., 822(N) (where N is an integer greater than 1). In the illustrated example, each hinge portion 822(n) has the same shape, but this is not necessarily required. Each illustrated hinge portion 822(n) is a rigid ring-shaped portion of the cylindrical element 820.

[0099]

[0117] Part 824 and hinge part 822(1) are arranged to be rotatable relative to each other by two rotatable sections 830(1) (only one is visible in Figure 8b), the two rotatable sections 830(1) being positioned 180° rotated relative to each other when viewed tangentially to the cylindrical element 821. One such rotatable section 830(1) is shown in detail in Figure 8c, as indicated by the dotted circle Vd in Figure 8b. The line connecting both rotatable sections 830(1) intersects the central axis of the hinge 821. Thus, part 824 and hinge part 822(1) are rotatable about this line.

[0100]

[0118] As shown in Figure 8c, the rotatable section 830(1) includes an extension 848(1) with a circular outer edge. This circular extension 848(1) is housed within a circular notch 850(1) of the hinge portion 822(1). The radius of the circular extension 848(1) and the radius of the circular notch 850(1) are the same. They have the same center of rotation. The circular extension 848(1) and the circular notch 850(1) are separated by a small slot created by a cutting operation, e.g., laser or water cutting, or any other suitable cutting technique. During the creation of the slot, the slot is interrupted in place, and thus the extension 848(1) and the notch 850(1) are still attached to each other by one or more small bridges 852(1). These bridges 852(1) act as “breaking elements” as defined above; that is, they break when a force exceeding a certain threshold is applied. Here, they are designed to break when the portion 824 and the hinge portion 822(1) are rotated relative to each other about the two extensions 848(1) with at least such a threshold force. The threshold force is selected such that the bridge 852(1) breaks before either the portion 824 or the hinge portion 822(1) deforms beyond its maximum elasticity due to the applied rotational force. As described below, they only break later in the manufacturing process.

[0101]

[0119] Reference numeral 844(1) refers to a mounting structure within the circular extension 848(1). The mounting structure 844(1) is positioned so that, after the cylindrical element 520 is inserted into the cylindrical element 820, the circular extension 848(1) can be attached to the pin 556(1) of the cylindrical element 520. Such attachment can be performed by any preferred attachment technique, including bonding, soldering, welding, and laser welding. To assist laser welding, the mounting structure 844(1) may be formed, for example, as a small S-shaped slotted structure made by laser cutting or water cutting.

[0102]

[0120] The hinge portion 822(1) may be provided with one or more lips 854(1) (one is shown in Figures 8b and 8c). Such lips 854(1) may be located adjacent to the lip 554(1) of the cylindrical element 520 (see Figure 5d). The lips 854(1) are used to attach the hinge portion 822(1) of the cylindrical tube 820 to the hinge portion 522(1) of the cylindrical element 520, for example, by welding or laser welding, after the cylindrical element 520 has been inserted into the cylindrical element 820. In this way, the hinge portions 502(1), 522(1), and 822(1) are securely attached to each other.

[0103]

[0121] Note that the extension 506(1) of the cylindrical element 500 is oriented in the same longitudinal direction as the extension 848(1) of the cylindrical element 820, but both of these extensions are oriented in the longitudinal direction opposite to that of the extension 548(1) of the cylindrical element 520. Therefore, the extension 548(1) can rotate around the pin 556(1) between the extensions 506(1) and 848(1), and this pin 556(1) is attached to the extension 506(1) at one end and to the extension 848(1) at the other end.

[0104]

[0122] Referring again to Figure 8a, hinge portions 822(1) and 822(2) are arranged to rotate relative to each other about two rotatable sections 830(2) (only one is shown in Figure 8a), and these two rotatable sections 830(2) are positioned 180° rotated relative to each other when viewed tangentially to the cylindrical element 820. The structure of the rotatable section 830(2) is preferably identical to that of the rotatable section 830(1). Thus, the rotatable section 830(2) preferably has the same elements as the rotatable section 830(1) shown in Figure 8c, where all indices (1) are replaced by (2). The rotatable section 830(2) is positioned 90° rotated relative to the position of the rotatable section 830(1) when viewed tangentially to the cylindrical element 820.

[0105]

[0123] In more general terms, the rotation mechanism between two adjacent hinge portions 822(n) and 822(n+1) is as follows: The hinge portions 822(n) and 822(n+1) are arranged to rotate relative to each other about two rotatable sections 830(n+1), which are rotated 180° relative to each other when viewed tangentially to the cylindrical element 820. The structure of the rotatable section 830(n+1) is preferably identical to that of the rotatable section 830(1). Thus, the rotatable section 830(n+1) has the same elements as the rotatable section 830(1) shown in Figure 8c, where all exponents (1) are replaced by (n+1). The rotatable section 830(n+1) is located at a position rotated 90° relative to the positions of the rotatable sections 830(n) and 830(n+2) when viewed tangentially to the cylindrical element 820. Preferably, the rotatable sections 830(n) and 830(n+2) are identical to the rotatable section 830(1).

[0106]

[0124] The portion 824 is provided with an outer edge portion 826 facing the outer edge portion 828 of the hinge portion 822(1). The outer edges 826 and 828 define an open space between them, and therefore, once the bridge 852(1) is damaged, the portion 824 and the hinge portion 822(1) can rotate freely relative to each other about the extension portion 848(1) to a predetermined bending angle reached when the outer edges 826 and 828 come into contact with each other.

[0107]

[0125] The outer edges 826 and 828 are formed by cutting a predetermined pattern into the cylindrical element 820, for example, by laser cutting or water cutting. All adjacent hinge portions 822(n), 822(n+1) have open spaces between them, such as the space defined between portion 824 and hinge portion 822(1), which are formed by cutting, for example, by laser cutting or water cutting. These spaces are rotated alternately by 90° when viewed tangentially to the cylindrical element 820.

[0108]

[0126] Since the consecutive rotatable sections 830(n) and 830(n+1) are rotated approximately 90° relative to each other when viewed tangentially to the cylindrical element 820, the hinge portion 822(n-1) and hinge portion 822(n) rotate relative to each other in a first direction, which is perpendicular to the second direction of rotation of hinge portion 822(n) relative to hinge portion 822(n+2). As shown in the figure, the rotational directions between the consecutive hinge portions alternate between the first and second directions, so that the hinge 821 is flexible in all directions.

[0109]

[0127] In one example, each notch 850(n) is still attached to the extension 848(n) by the bridge 852(n) when a slot is created between the notch 850(n) and the extension 848(n). Therefore, after the cylindrical element structure 820 in Figure 8b is fabricated, in such an example all the various parts are still attached to each other, and the structure does not break down into separate parts. Thus, when ready, the cylindrical element structure 820 in Figure 8a is still a single unit when ready to insert the cylindrical elements 520 into the cylindrical element structure 820. Furthermore, before being inserted into each other, both cylindrical elements 520, 820 still have a linear structure by all the bridges 552(n), 852(n), which facilitates the operation of inserting the two cylindrical elements 520, 820 into each other.

[0110]

[0128] Bridges 852(1) and 840(1) are designed as “fracture elements” as defined above herein; that is, they break when a predetermined force is applied that is less than the force required to deform the surrounding material beyond its maximum elasticity.

[0111]

[0129] Figure 8b shows the resulting hinge structure when the cylindrical elements 500, 520, and 820 are inserted into each other. As shown in the figure, in the assembled state, the cylindrical elements 500, 520, and 820 are aligned longitudinally and tangentially with each other such that each rotatable section 530(n) of cylindrical element 520 aligns with both one rotatable section 507(n) of cylindrical element 500 and one rotatable section 830(n) of cylindrical element 820. To complete the assembly, after inserting cylindrical element 500 into cylindrical element 520, each pin 556(n) is attached to one circular extension 506(n) by, for example, a mounting structure 544(n) by, for example, adhesive, soldering, welding, or laser welding. After inserting the cylindrical element 520 into the cylindrical element 820 together with the cylindrical element 500, each extension 848(n) is attached to the pin 556(n) by, for example, a mounting structure 844(n) by adhesive, soldering, welding, or laser welding.

[0112]

[0130] Optionally, one or more hinge portions 822(n) may also be attached to hinge portion 522(n), for example, by bonding, soldering, welding, and / or laser welding the lip 854(n) to the lip 554(n). This latter action provides greater rigidity to the entire hinge structure.

[0113]

[0131] Part 829 can be attached to part 529 in a similar manner, for example, by bonding, soldering, welding, or laser welding the lip 834 to part 529, or by any other preferred method. Similarly, parts 524 and 824 can be attached to each other.

[0114]

[0132] After the cylindrical elements 500, 520, and 820 are mounted to each other in this manner, the user can apply a rotational force in the direction indicated by the double arrow 803 in Figure 8a. When the rotational force exceeds a certain threshold, all the “breaking elements” 510(n), 540(n), 552(n), and 852(n) break. As a result, parts 504 / 524 / 824 can rotate freely around pin 556(1) relative to adjacent hinge parts 502(1) / 522(1) / 822(1), and hinge parts 502(n) / 522(n) / 822(n) can rotate freely around pin 556(n+1) relative to adjacent hinge parts 502(n+1) / 522(n+1) / 822(n+1). Similarly, parts 509 / 529 / 829 can rotate freely relative to hinge parts 502(N) / 522(N) / 822(N).

[0115]

[0133] Furthermore, each circular island 856(n) is securely attached to a circular extension 548(n) within the cylindrical element 520 and can rotate freely with it within the extension 848(n) of the cylindrical element 820. This structure allows the circular island 856(n) to act as a pin or spindle with two functions. First, it acts as a pivot pin that is the center of rotation for the extension 848(n). Second, because the slot between the pin 856(n) and the extension 848(n) can be made very narrow, the pin 856(n) acts to keep the hinge portions 822(n) / 522(n) and adjacent hinge portions 822(n+1) / 522(n+1) in clearly defined positions relative to each other with little play between them. The same applies to the position of part 824 / 524 relative to hinge part 822(1) / 522(1) and the position of hinge part 822(N) / 522(N) relative to part 829 / 529.

[0116]

[0134] Figures 9a, 9b, and 9c show one embodiment of the hinge structure of the present invention applied to a steerable device having longitudinal elements formed by cutting out cylindrical elements and arranged as steering strips for the steerable device. Such a steerable device may be based on any one of the devices shown with reference to Figures 1 to 4. Hereinafter, the application of the hinge structure of the present invention will be described with reference to a steerable device having a steering strip on one cylindrical element. However, the present invention can be applied to any steerable device having one or more cylindrical elements having a steering strip formed by cutting out cylindrical elements.

[0117]

[0135] Figure 9a shows an inner cylindrical element, and Figure 9b shows an intermediate cylindrical element having such a steering strip with the inner cylindrical element inserted inside. Figure 9c shows an outer cylindrical element with the set of inner and intermediate cylindrical elements inserted inside.

[0118]

[0136] Figure 9a shows an example of the tip of an inner cylindrical element 920, which may be located at the distal or proximal end of the device. While this description assumes it is located at the distal end, a similar configuration may be located at the proximal end. Alternatively, the steering strip may be steered by a ball-shaped member or a motor of a robotic steering mechanism. As described above, the tip of the device is steerable. The inner cylindrical element may be fully flexible and can be made from any suitable material, including any type of plastic or metal that can be used in a medical environment. The structure in Figure 9a is just one example of a possible embodiment in which flexibility is provided by a slotted hinge structure 921.

[0119]

[0137] The slotted hinge structure 921 is positioned proximal to the end of the ring-shaped end portion 924 of the cylindrical element 920. The slotted hinge structure 921 comprises a plurality of hinge portions 922(1), 922(2), ..., 922(n), ..., 922(N). The end portion 924 is rotatably positioned relative to hinge portion 922(1), and hinge portion 922(N) is rotatably positioned relative to a cylindrical element portion 929 positioned proximal to the end of the hinge structure 921.

[0120]

[0138] The end portion 924 can rotate around the hinge portion 922(1) about two rotating sections 930(1) that are rotated 180° relative to each other when viewed tangentially to the cylindrical element 920. That is, the line connecting the two rotating sections 930(1) intersects the axis of symmetry of the cylindrical element 920. When the end portion 924 rotates around the hinge portion 922(1), the rotation is centered on this line.

[0121]

[0139] Between each pair of adjacent hinge portions 922(n) and 922(n+1), there are two rotational sections 930(n+1), and therefore they can rotate relative to each other about a line connecting these two rotational sections 930(n+1). In one embodiment, all rotational sections 930(n) are identical, but this is not strictly necessary.

[0122]

[0140] An example of such a rotating section 930(n) is provided with reference to rotating section 930(2). Rotating section 930(2) is located between hinge portions 922(1) and 922(2). A second rotating section 930(2) is located 180° rotated with respect to the position of rotating section 930(2). Rotating section 930(2) comprises a circular extension 948(2) of hinge portion 922(1). The extension 948(2) is housed within a circular notch 950(2) of hinge portion 922(2). The extension 948(2) and the notch 950(2) are separated by a slot cut into the cylindrical element 920. For example, while cutting by laser cutting or water cutting to create a slot, the extension 948(2) and the notch 950(2) remain attached to each other by the small bridge 952(2) which acts as the “breaking element” described above. That is, they are designed to break when the hinge portions 922(1) and 922(2) are rotated relative to each other by a predetermined force that is below the force required to deform the surrounding material of the hinge portions 922(1) and 922(2) beyond their maximum elasticity, but above a certain threshold force.

[0123]

[0141] The center point of the extension 948(2) defines the rotation point at which the hinge portions 922(1) and 922(2) become rotatable when the bridge 952(2) is damaged.

[0124]

[0142] The rotating section 930(2) also comprises two lip elements 960(2) and 962(2) extending from the hinge portion 922(2) toward the hinge portion 922(1). Both lip elements 960(2) and 962(2) have a circular shape and are located at a radial distance from the point of rotation that is greater than the radius of the circular extension 948(2). Lip element 960(2) can move circularly within a circular slot 964(2) located in the hinge portion 922(1). Lip element 962(2) can move circularly within a circular slot 966(2) located in the hinge portion 922(1).

[0125]

[0143] The lip elements 960(2), 962(2), and the circular slots 964(2), 966(2) can be formed by cutting a predetermined pattern into the cylindrical element 920, for example by laser cutting or water cutting, as will be apparent to those skilled in the art. During the cutting process, the lip elements 960(2) and 962(2) may remain attached to the surrounding material away from the hinge portion 922(1) by small bridges acting as the aforementioned “breaking elements”.

[0126]

[0144] The lip elements 960(2) and 962(2) house a portion of the hinge portion 922(1), which includes the circular extension 948(2), thereby preventing the hinge portions 922(1) and 922(2) from easily moving relative to each other in the longitudinal direction of the cylindrical element 920.

[0127]

[0145] The hinge portion 922(1) has an edge 968 facing the edge 970 of the hinge portion 922(2), which is molded to define a predetermined open space between the hinge portions 922(1) and 922(2). The lengths of this open space and the slots 964(2) and 966(2) determine the angle at which the hinge portions 922(1) and 922(2) can rotate relative to each other.

[0128]

[0146] It should be noted that if the hinge portions 922(1) and 922(2) are rotated relative to each other with a predetermined force exceeding a predetermined threshold in the direction indicated by the double arrow 903, the fracture element 952(2) (and the possible fracture elements that attach the lip elements 960(2) and 962(2) to the adjacent material of the hinge portion 922(1)) will break, and as a result, the hinge portions 922(1) and 922(2) will no longer be attached to each other and will be able to rotate freely. However, it is preferable not to do this before inserting the inner cylindrical element 920 into the intermediate cylindrical element 1000 shown in Figure 9b.

[0129]

[0147] In this case as well, the consecutive rotating sections 930(n) and 930(n+1) are rotated 90° tangentially to the cylindrical element 920, providing the hinge structure 921 with full flexibility in all directions.

[0130]

[0148] Figure 9b shows an example of an intermediate cylindrical element 1000. The intermediate cylindrical element 1000 has a ring-shaped distal end portion 1002 to which several steering strips 1004 are attached, which are made by cutting out the cylindrical element 1000 and forming longitudinal elements, for example, by laser cutting or water cutting. Two such steering strips 1004 are sufficient when bendability in one direction (and opposite directions) is desired. However, if bendability in all directions is desired, at least three steering strips 1004 should be used. In one example, the steering strips 1004 are positioned equidistant from each other in the tangential direction. In this example, eight such steering strips 1004 are used.

[0131]

[0149] As shown in Figure 9b, two adjacent steering strips 1004 are prevented from moving tangentially relative to each other by tangential spacers. Two different sets of tangential spacers are shown. The first set comprises a spacer 1028 formed as a longitudinal strip having spacer elements on both sides that extend tangentially to the extent that they contact the adjacent steering strips 1004. These spacer elements may have any desired form, namely flexible plate-like elements, M-shaped elements, S-shaped elements, pin-shaped elements, or any other suitable form known to those skilled in the art. Alternatively, the spacer 1028 may be formed as a flexible plate-like element, M-shaped element, S-shaped element, pin-shaped element, or any other suitable form known to those skilled in the art, which is directly attached to one of the two adjacent steering strips 1004 and extends to the other of the two adjacent steering strips 1004, as known from the prior art.

[0132]

[0150] The second set of tangential spacers comprises a plurality of spacer elements 1005 arranged longitudinally and continuously between two adjacent steering strips 1004. The first set of spacers 1028 and the second set of spacers 1005 are alternated tangentially to the cylindrical element 1000.

[0133]

[0151] Each spacer element 1005 comprises a plate 1006 separated from the adjacent steering strip 1004 by a slot resulting from a cut into the cylindrical element 1000, such as laser cutting or water cutting. During the cutting process, the plate 1006 remains attached to one or both adjacent steering strips 1004, preferably by a "breaking element" 1012, which is described herein as a breaking element. The breaking element 1012 is designed to break when a relative longitudinal force is applied between the steering strip 1004 and the plate 1006 to which the breaking element 1012 is attached, and the force exceeds a certain threshold force. The threshold force should be selected such that the resulting force on the steering strip 1004 and the plate 1006 remains below their maximum elasticity.

[0134]

[0152] In the illustrated embodiment, plate 1006 is attached to a further plate 1014 separated from the adjacent steering strip 1004 by a slot created by cutting into a cylindrical element 1000, for example, by laser cutting or water cutting. During cutting, plate 1014 remains attached to one or both adjacent steering strips 1004, preferably by a “breaking element” 1016. The breaking element 1016 is designed to break when a relative longitudinal force is applied between the steering strip 1004 and the plate 1014 to which the breaking element 1016 is attached exceeds a certain threshold force. The threshold force should be selected such that the resulting forces on the steering strip 1004 and plate 1014 remain below their maximum elasticity.

[0135]

[0153] In one example, plate 1006 is attached to plate 1014 by a flexible mounting strip 1018, so that they are positioned at a predetermined longitudinal distance from each other. Thus, the mounting strip 1018 can extend into plate 1014 (and / or plate 1006) by having slots on both sides, as shown in Figure 9b.

[0136]

[0154] Plate 1014 has an edge 1020 facing toward the distal end, and plate 1006 has an edge 1022 facing toward the proximal end. The continuous spacer elements 1005 are positioned longitudinally at a predetermined distance from each other, determined by the specific required flexibility of the device.

[0137]

[0155] When the cylindrical elements 920 and 1000 are manufactured, both are integral cylindrical elements in which all the various components are still attached to each other by the breaking elements, as described above. They are still straight, and the cylindrical element 920 can be easily inserted into the cylindrical element 1000. Once inserted into each other, they are aligned in both the longitudinal and tangential directions. Then, in one embodiment, the ends 924 and 1002 are attached to each other, for example, by adhesive, soldering, welding, laser welding, etc.

[0138]

[0156] When inserted into each other, the set of cylindrical elements 920, 1000 is inserted into a cylindrical element which may have the same shape as the cylindrical element 520 described with reference to Figures 5b and 5d. Figure 9c shows the (e.g., distal) end structure of a device in which this has been done. The set of cylindrical elements 920, 1000 is aligned with the cylindrical element 520 both longitudinally and tangentially. This alignment ensures that each pin 556(n) located inside the hinge portion 522(n-1) is radially aligned and mounted to a portion 1008 of the plate 1006. This may be done by a mounting structure 544(n), if present. Mounting can be done by adhesive, welding, laser welding, etc. Furthermore, a portion of the hinge portion 522(n) located longitudinally offset from the pins 556(n) is mounted to the plate 1006 in portion 1010, which is also longitudinally offset from portion 1008. This portion of the hinge portion 522(n) may be a lip 554(n). In this way, each pin 556(n) located inside the hinge portion 522(n-1) is securely attached to the hinge portion 522(n) by a single plate 1006 which itself is located within the intermediate cylindrical element 1000. Furthermore, the plate 1006 also functions as a tangential spacer between adjacent steering strips within the intermediate cylindrical element 1000.

[0139]

[0157] Preferably, after alignment in the longitudinal and tangential directions, the end portion 524 is attached to the end portion 1002.

[0140]

[0158] After all three cylindrical elements 920, 1000, and 520 are inserted into each other, aligned longitudinally and tangentially as desired, and attached to one another, as described above, the user can bend the device by applying a rotational force 903 (see Figure 9a) in all directions with such force that all fracturing elements, which still keep the separate components attached to each other, break, but the surrounding material does not experience a force exceeding its maximum elasticity. Then, all the rotating sections within the inner cylindrical element 920 and the outer cylindrical element 520 become free to rotate. Then, as some components bend elastically, only a reaction force against any bending occurs in the intermediate cylindrical element 1000.

[0141]

[0159] Naturally, the devices in Figures 9a, 9b, and 9c can be given greater overall rigidity by applying additional outer cylindrical elements, such as cylindrical element 820 (Figure 8a).

[0142]

[0160] While the embodiments in Figures 9a, 9b, and 9c show the plate 1006 being inside the rotating section 530(n), the cylindrical elements 1000 and 520 may be designed such that the cylindrical element 520 is inserted into the cylindrical element 1000, and the plate 1006 is located outside the rotating section 530(n).

[0143]

[0161] Figures 10a and 10b show one embodiment of the hinge structure of the present invention applied to a steerable device having a steering cable or wire acting as a steering element of the steerable device. Such a steerable device may be based on any steerable device with a steering cable known from the prior art. For example, such a steerable device may be based on any one of the embodiments described in Non-Prior Publication PCT / NL2019 / 0506850.

[0144]

[0162] Figure 10a shows an intermediate cylindrical element 1000a, to which a steering cable 1004a is provided, assembled and coaxially aligned with the inner cylindrical element 920 shown in Figure 9a. Figure 10b shows the inner cylindrical element 920 and intermediate cylindrical element 1000a assembled with the outer cylindrical element 520a and aligned in the longitudinal and tangential directions. Note that the outer cylindrical element 520a may be the same as the outer cylindrical element 520 shown in Figure 9c.

[0145]

[0163] Figure 10a shows an example of an intermediate cylindrical element 1000a that is substantially similar to the intermediate cylindrical element 1000 in Figure 9b, but features a steering cable 1004a instead of a steering strip 1004. In Figure 10a, elements corresponding to the elements in Figure 9b are indicated by the corresponding reference number given the suffix "a". These features are advantageously similar to the corresponding features described with reference to Figure 9b and should be understood, as those skilled in the art will see, may be modified where applicable to facilitate the use of a steering cable 1004a instead of a steering strip 1004. Therefore, descriptions of various features are not repeated herein.

[0146]

[0164] The intermediate cylindrical element 1000a comprises a ring-shaped distal end portion 1002a attached to a plurality of steering cables 1004a. When bending in one direction (and the opposite direction) is desired, two such steering cables 1004a are sufficient. However, when bending in all directions is desired, at least three steering cables 1004a should be used. In one example, the steering cables 1004a are positioned equidistant from each other in the tangential direction.

[0147]

[0165] As shown in Figure 10a, two adjacent steering cables 1004a are prevented from moving tangentially relative to each other by tangential spacers. Two different sets of tangential spacers are shown. The first set comprises a spacer 1028a formed as a longitudinal strip having spacer elements on both sides that extend tangentially to the extent that they contact the adjacent steering cables 1004a.

[0148]

[0166] The second set of tangential spacers comprises a plurality of spacer elements 1005a arranged longitudinally and continuously between two adjacent steering cables 1004a. The first set of spacers 1028a and the second set of spacers 1005a are alternated tangentially to the cylindrical element 1000a.

[0149]

[0167] Each spacer element 1005a is provided with a plate 1006a separated from the adjacent steering cable 1004a by a slot.

[0150]

[0168] In the illustrated embodiment, plate 1006a is attached to an additional plate 1014a separated from the adjacent steering cable 1004a by a slot.

[0151]

[0169] In one example, plate 1006a is attached to plate 1014a by a flexible mounting strip 1018a, thereby positioning them at a predetermined longitudinal distance from each other.

[0152]

[0170] When the cylindrical elements 920 and 1000a are manufactured, both are integral cylindrical elements in which all the various components are still attached to each other by the breaking element, as described above. They are still straight, and the cylindrical element 920 can be easily inserted into the cylindrical element 1000a. Once inserted into each other, they are aligned in both the longitudinal and tangential directions. Then, in one embodiment, the ends 924 and 1002a are attached to each other by, for example, adhesive, soldering, welding, laser welding, etc.

[0153]

[0171] When inserted into each other, the set of cylindrical elements 920, 1000a is inserted into a cylindrical element which may have the same shape as the cylindrical element 520 described with reference to Figures 5b and 5d. Figure 10b shows the (e.g., distal) end structure of the device in which this has been done. The set of cylindrical elements 920, 1000a is aligned with the cylindrical element 520 in both the longitudinal and tangential directions. This alignment is such that each pin 556(n) located inside the hinge portion 522(n-1) is radially aligned and mounted with a portion 1008a of the plate 1006a. This may be done by a mounting structure 544(n), if present. Mounting can be done by adhesive, welding, laser welding, etc. Furthermore, a portion of the hinge portion 522(n), located longitudinally offset from pin 556(n), is attached to plate 1006a in portion 1010a, which is also longitudinally offset from portion 1008a. This portion of the hinge portion 522(n) may be a lip 554(n). In this way, each pin 556(n) located inside the hinge portion 522(n-1) is securely attached to the hinge portion 522(n) by a single plate 1006 which itself is located within the intermediate cylindrical element 1000a. Furthermore, plate 1006a also functions as a tangential spacer between adjacent steering cables within the intermediate cylindrical element 1000a.

[0154]

[0172] Preferably, after alignment in the longitudinal and tangential directions, the end portion 524 is attached to the end portion 1002a.

[0155]

[0173] After all three cylindrical elements 920, 1000a, and 520 are inserted into each other, aligned longitudinally and tangentially as desired, and attached to one another, as described above, the user can bend the device by applying a rotational force 903 (see Figure 9a) in all directions with such force that all fracturing elements, which still keep the separate components attached to each other, break, but the surrounding material does not experience a force exceeding its maximum elasticity. Then, all the rotating sections within the inner cylindrical element 920 and the outer cylindrical element 520 become free to rotate. Then, as some components bend elastically, a reaction force against any bending occurs only in the intermediate cylindrical element 1000a.

[0156]

[0174] Naturally, the equipment in Figures 10a and 10b can be given greater overall rigidity by applying additional outer cylindrical elements, such as cylindrical element 820 (Figure 8a).

[0157]

[0175] While the embodiments in Figures 10a and 10b show that the plate 1006a is located inside the rotating section 530(n), the cylindrical elements 1000a and 520 may be designed such that the cylindrical element 520 is inserted into the cylindrical element 1000a, and the plate 1006a is located outside the rotating section 530(n).

[0158]

[0176] The present invention is not limited to the embodiments described herein. In the embodiments described above, adjacent hinge portions 522(n), 522(n+1) of the cylindrical hinge 521 are rotatable relative to each other, since one of them has two holes located tangentially opposite to each other. Each hole houses a pin 556(n) attached to elements 506(n), 1006 inside the cylindrical hinge 521 and / or attached to element 848(n) outside the cylindrical element 521. The elements 506(n), 1006, or 848(n) are also attached to a portion of the other hinge portion. Thus, the pin remains inside its corresponding hole, and adjacent hinge portions remain at a clearly defined distance from each other. They can rotate freely relative to each other about the pin 556(n).

[0159]

[0177] However, the pin itself does not need to be the center of rotation, as explained with reference to Figure 11.

[0160]

[0178] Figure 11 shows an alternative configuration of the outer cylindrical element 520. Figure 11 shows a cylindrical element 1000 inserted into a cylindrical element 1100. Inside the cylindrical element 1000, there may be any other suitable flexible cylindrical elements as described above with reference to the cylindrical element 920. Again, there may be more cylindrical elements having steering strips to control the bending of the deflectable section of the equipment. Alternatively, instead of the cylindrical element 1000, a cylindrical element 1000a may be inserted into the cylindrical element 1100 in a manner similar to the configuration described below herein with reference to the cylindrical element 1000.

[0161]

[0179] The cylindrical element 1100 has an end portion 1124 which may be located at the distal end of the device. However, it may alternatively be at the proximal end. Adjacent to the end portion 1124, the cylindrical element 1100 comprises a plurality of hinge portions 1122(1), 1122(2), ..., 1122(n), ..., 1122(N) of a (cylindrical) hinge 1121. The end portion 1124 is rotatable relative to the hinge portion 1122(1), and similarly, the end portion 1129 is rotatable relative to the hinge portion 1122(N).

[0162]

[0180] Each hinge portion 1122(n-1) is rotatable relative to an adjacent hinge portion 1122(n) by two rotatable sections 1130(n). End portion 1124 is rotatable relative to an adjacent hinge portion 1122(1) by two rotatable sections 1130(1). Hinge portion 1122(N) is rotatable relative to an end portion 1129 by two rotatable sections 1130(N+1). Each of the two rotatable sections 1130(n) is positioned 180° rotated relative to each other when viewed tangentially.

[0163]

[0181] The rotating section 1130(1) is shown in more detail. However, all other rotating sections 1130(n) are preferably formed in the same manner.

[0164]

[0182] The end portion 1124 has an outer edge 1126 facing the outer edge 1128 of the hinge portion 1122(1). The outer edges 1126 and 1128 are designed to define an open space between the end portion 1124 and the hinge portion 1122(1). The edges 1126 and 1128 contact each other only at two predetermined positions 1160(1). During manufacturing, these open spaces can be formed by cutting a predetermined pattern into the cylindrical element 1100, for example, by laser cutting or water cutting. A breaking element may be applied at position 1160(1) to keep the end portion 1124 and the hinge portion 1122(1) attached to each other, as long as the cylindrical element 1000 has not yet been inserted into the cylindrical element 1100. Position 1160(1) is the center of rotation.

[0165]

[0183] The hinge portion 1122(1) is provided with a pin 1156(1) that can move inside a slot 1158(1) within the hinge portion 1122(1). The slot 1158(1) is made by cutting into the hinge portion 1122(1), for example by laser cutting or water cutting, and simultaneously forms the pin 1156(1). Thus, the pin 1156(1) is a disc resulting from the cut into the hinge portion 1122(1). The slot 1158(1) has a circular shape positioned on the arc of a circle whose center is at the same position as the rotation center 1160(1).

[0166]

[0184] Once the cylindrical element 1100 is ready, the cylindrical element 1000 is inserted into the cylindrical element 1100 and properly aligned in both the longitudinal and tangential directions. Note that in this embodiment, the cylindrical element 1000 has spacer elements 1005 under all rotating sections 1130(n), which differs from Figure 9c, which shows a slightly different spacer structure under the center of rotation 1130(1). In the embodiment of Figure 11, the plate 1014 of the spacer element 1005 under the rotating section 1130(1) may be part of the end portion 1002. The center of rotation 1160(1) is aligned so as to be radially aligned with the flexible portion of the mounting strip 1018 between the plate 1014 and the plate 1006. The pin 1156(1) is attached to the plate 1006 by, for example, adhesive, welding, laser welding, etc. Furthermore, a portion of the end portion 1124 adjacent to the rotation center 1160(1) is attached to the plate 1014 by, for example, adhesive, welding, or laser welding. This portion of the end portion 1124 may be a lip 1154(1) cut into the end portion 1124. In this way, the pin 1156(1) is attached to the end portion 1124 but is properly held in place within the slot 1158(1). The mounting strip 1018 prevents longitudinal displacement between the end portion 1124 and the hinge portion 1122(1). Since the rotation center 1160(1) is located on the flexible portion of the mounting strip 1018 when viewed radially, the end portion 1124 and the hinge portion 1122(1) can rotate relative to each other about the rotation center 1160(1).

[0167]

[0185] The end portion 1124 is preferably attached to the end portion 1002 by, for example, welding, bonding, or laser welding.

[0168]

[0186] The two rotating sections 1130(n) between adjacent hinge portions 1122(n-1) and 1122(n) preferably have the same design as the rotating section 1130(1). The rotation center 1160(n) is positioned so as to be radially aligned with the flexible portion of the mounting strip 1018 between plate 1014 and plate 1006. The pin 1156(n) is attached to plate 1006 by means of, for example, adhesive, welding, laser welding, etc. Furthermore, a portion of the hinge portion 1122(n-1) adjacent to the rotation center 1160(n) is attached to plate 1014 by means of, for example, adhesive, welding, laser welding, etc. This portion of the hinge portion 1122(n-1) may be a lip cut into the hinge portion 1122(n-1). In this way, the pin 1156(n) is attached to the hinge portion 1122(n-1) but is properly held in place in the slot 1158(n). The mounting strip 1018 prevents longitudinal displacement between the hinge portion 1122(n-1) and the hinge portion 1122(n). Since the rotation center 1160(n) is located on the flexible portion of the mounting strip 1018 when viewed radially, the hinge portions 1122(n-1) and 1122(n) can rotate relative to each other about the rotation center 1160(n).

[0169]

[0187] In the embodiments described herein, pin 556(n) has been described as having a substantially flat disc shape that can be attached to the mounting member, i.e., extensions 506(n) and 848(n), by adhesive, soldering, welding, or laser welding. However, in alternative embodiments, pin 556(n) may be formed by an elongated structure having or provided with a projection and / or having a radial extension, so that pin 556(n) can be attached to the mounting member, i.e., extension 506(n), by a mechanical connection such as a snap fit or shape fit or similar, so that the pin is rotatably fastened to the mounting member. For example, the mounting member may be provided with a mounting member opening into which the projection or elongated structure of the pin can be inserted and secured, for example, by the projection or elongated structure having a diameter equal to or slightly larger than the mounting member opening. The pin can be fastened to extension 848(n) or plate 1006 in a similar manner.

[0170]

[0188] Here too, the consecutive rotation centers 1130(n-1) and 1130(n) are preferably located at positions rotated 90° relative to each other when viewed tangentially. In this case, the entire structure can be bent in any desired direction.

[0171]

[0189] It should be noted that when the user first applies rotational force, the user will break the aforementioned fracture elements located between the edges 1126 and 1128 at the rotation center 1160(1), and between the pin 1156(1) and the surrounding material of the hinge portion 1122(1). It should also be noted that in Figure 11, the pin 1156(1) is shown to have the shape of a circular arc, which is the same as but shorter in length as the slot 1158(1). However, the pin 1156(1) may have any other preferred shape, such as a circle. The same applies to all other fracture elements and each of the pins 1156(n). All pins 1156(n) may be provided with special mounting structures, such as a slotted structure 1144(n), to support mounting by laser welding or the like.

[0172]

[0190] Because the gaps between adjacent cylindrical elements are very small, they can easily move relative to each other in the longitudinal direction unless they are attached to one another, while keeping their radial play to a minimum. The gaps between them may be in the range of 0.02 to 0.1 mm. The thickness of the cylindrical elements may be in the range of 0.1 to 2.0 mm, preferably 0.1 to 1.0 mm, more preferably 0.1 to 0.5 mm, and most preferably 0.2 to 0.4 mm. The diameter of the cylindrical elements 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.

[0173]

[0191] While the embodiments illustrated in Figures 5 to 11 are described with reference to the distal end 13 of the steerable device, it should be understood that the hinges described herein can also be applied to other sections of the steerable device.

[0174]

[0192] All cylindrical elements described herein are preferably manufactured from a single cylindrical tube made of any suitable material such as stainless steel, cobalt-chromium, shape memory alloys such as Nitinol®, plastics, polymers, composite materials, or other cuttable materials. Alternatively, cylindrical elements can be manufactured by a 3D printing process. The thickness of the tube depends on its application. For medical applications, the thickness may be in the range of 0.1 to 2.0 mm, preferably 0.1 to 1.0 mm, more preferably 0.1 to 0.5 mm, and most preferably 0.2 to 0.4 mm. The diameter of the inner cylindrical element depends on its application. For medical applications, 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.

[0175]

[0193] Slots and openings in all cylindrical elements can be fabricated by laser or water cutting. Smaller slots, fabricated solely to separate adjacent elements, may preferably have a width in the range of 5 to 50 μm, more preferably 15 to 30 μm.

[0176]

[0194] The scope of the present invention is not limited to the examples described above, and it will be apparent to those skilled in the art that multiple variations and modifications thereof are possible without departing from the scope of the invention as defined in the appended claims. While the present invention has been illustrated and described in detail in the figures and description, such examples and descriptions should be considered illustrative or exemplary and not limiting. The present invention is not limited to the disclosed embodiments and comprises any combination of disclosed embodiments that may provide advantages.

[0177]

[0195] The above embodiment is shown with flexible zones 14 and 15 at the proximal end of the device, which are arranged to control the bending of flexible zones 16 and 17 at the distal end by two sets of longitudinal elements. The flexible zones 14 and 15 can be replaced by other actuators, such as suitable motors, which are arranged to control the movement of the longitudinal elements. In a further alternative embodiment, such actuators may be constructed as balls to which the longitudinal elements are attached. Rotating the ball causes the longitudinal elements to move longitudinally, and thus the bending of the flexible zones 16 and 17 is controlled. This also applies to devices having a steerable flexible zone at its distal end, as described with reference to Figures 2g, 2h, and 2i.

[0178]

[0196] Variations of the disclosed embodiments can be understood and achieved by a person skilled in the art when carrying out the claimed invention by reference to the drawings, description and appended claims. In the description and claims, the word “equipped with” does not exclude other elements, and the indefinite article “a” or “an” does not exclude plurals. In fact, it should be interpreted as meaning “at least one.” The mere fact that certain features are described in different dependent claims does not indicate that combinations of these features cannot be used advantageously. None of the reference numerals in the claims should be interpreted as limiting the scope of the invention. The features of the embodiments and aspects described above can be combined insofar as they do not result in obvious technical inconsistencies. The invention described in the original claims of this application is listed below. [1] A cylindrical element (520;1100) having a central axis (520c;1100c) and a hinge structure, The first part (524;1124;522(n-1);1122(n-1)), The second part (522(1);1122(1);522(n);1122(n)) is located at the same distance from the central axis as the first part, and is rotatable with respect to the first part (524;1124;522(n-1);1122(n-1)) about two rotating sections (530(1);1130(1);530(n);1130(n)) which are positioned 180° to each other when viewed tangentially to the cylindrical element. Mounting elements (502(1); 1006; 502(n)), Pins (556(1);1156(1);556(n);1156(n)) and Equipped with, The aforementioned rotating section (530(1); 1130(1); 530(n); 1130(n)) is An opening for accommodating the pins (556(1);1156(1);556(n);1156(n)) is provided in either the first portion (524;1124;522(n-1);1122(n-1)) or the second portion (522(1);1122(1);522(n);1122(n)). The pins (556(1)); 1156(1); 556(n); 1156(n)) are attached to a portion (506(1); 506(n)) of the mounting element (502(1); 1006; 502(n)), and The other of the first portion (524;1124;522(n-1);1122(n-1)) and the second portion (522(1);1122(1);522(n);1122(n)) is attached to another portion of the mounting element (502(1);1006;502(n)), This was achieved by A cylindrical element wherein the first portion (524;1124;522(n-1);1122(n-1)) and the second portion (522(1);1122(1);522(n);1122(n)) are configured to be unable to move relative to each other in the longitudinal, tangential, and radial directions, but to rotate relative to each other about a center of rotation. [2] The cylindrical element according to [1], wherein the first and second portions are arranged so as not to overlap each other in a radial direction extending substantially perpendicular to the central axis. [3] The first portion or the second portion having the opening comprises the first rotating section portion (548(1)) having the opening, The cylindrical element according to [1] or [2], wherein the first part or the other of the second part comprises a second rotating section part (550(1)) that at least partially encloses the first rotating section part, the second rotating section part being at least partially attached to the mounting element. [4] The cylindrical element according to [3], wherein the first and second rotating section portions are located at the same distance from the central axis. [5] The cylindrical element according to [3] or [4], wherein the first rotating section portion and the second rotating section portion are sections having complementary shapes or shapes that rotatably fit together. [6] The cylindrical element according to any one of [3] to [5], wherein the first rotating section portion is formed as an extension (548(1)) having a slot (542(1)) defining the outer edge of the opening, and an island (556(1)) forming the pin is formed within the opening, and the second rotating section portion is formed by a notch (550(1)). [7] The cylindrical element according to any one of [1] to [6], wherein the first and second parts are made from a single cylindrical element, for example, by laser cutting or water cutting. [8] The cylindrical element according to any one of [1] to [7], wherein the mounting element is located at a different distance from the central axis than the first and second portions. [9] The cylindrical element according to any one of [1] to [8], wherein the mounting element is a hinge portion (502(1); 502(n)) of a further hinge structure within a further cylindrical element (500) located inside the cylindrical element.

[10] The cylindrical element according to any one of [1] to [8], wherein the mounting element is a tangential spacer (1006) between adjacent steering strips (1004) in a further cylindrical element located inside the cylindrical element.

[11] The cylindrical element according to any one of [1] to [7], wherein the mounting element is a tangential spacer (1006) between adjacent steering cables (1004a) in a further cylindrical element located inside the cylindrical element.

[12] The cylindrical element according to any one of [1] to

[11] , wherein the opening is a circular opening having a center forming the center of rotation, and the pins (556(1); 556(n)) are arranged in the opening so as to be rotatable about the center of rotation.

[13] The cylindrical element according to any one of [1] to [3], wherein the opening is a slot (1158(1); 1158(n)) arranged along an arc of a circle having a center forming the center of rotation, and the pin (1156(1); 1156(n)) is arranged in the slot so as to be movable within the slot along the arc of the circle.

[14] The cylindrical element according to any one of [1] to

[13] , wherein the pin is a disc formed by cutting out a piece of material located within the opening before cutting the opening.

[15] A steerable device comprising a cylindrical element as described in any one of items [1] to

[14] .

[16] The steerable device according to

[15] , relating to either

[10] or

[11] , wherein the steerable device comprises a steerable distal end portion by the steering strip (1004) or the steering cable (1004a), the steering strip (1004) being a longitudinal element formed by cutting out the further cylindrical element (1000).

[17] The stairable device according to

[16] , wherein the tangential spacer (1006) is a portion formed by cutting out the further cylindrical element (1000).

[18] A method for manufacturing a cylindrical element having a central axis and a hinge structure, wherein the cylindrical element is The first part (524;1124;522(n-1);1122(n-1)), The second part (522(1);1122(1);522(n);1122(n)) is located at the same distance from the central axis as the first part, and is rotatable with respect to the first part (524;1124;522(n-1);1122(n-1)) about two rotating sections (530(1);1130(1);530(n);1130(n)) which are positioned 180° to each other when viewed tangentially to the cylindrical element. Mounting elements (502(1); 1006; 502(n)), Pins (556(1);1156(1);556(n);1156(n)) and Equipped with, The aforementioned rotating section (530(1); 1130(1); 530(n); 1130(n)) is An opening for accommodating the pins (556(1);1156(1);556(n);1156(n)) is provided in either the first portion (524;1124;522(n-1);1122(n-1)) or the second portion (522(1);1122(1);522(n);1122(n)). The pins (556(1)); 1156(1); 556(n); 1156(n)) are attached to a portion (506(1); 506(n)) of the mounting element (502(1); 1006; 502(n)), and The other of the first portion (524;1124;522(n-1);1122(n-1)) and the second portion (522(1);1122(1);522(n);1122(n)) is attached to another portion of the mounting element (502(1);1006;502(n)), This was achieved by As a result, the first part (524;1124;522(n-1);1122(n-1)) and the second part (522(1);1122(1);522(n);1122(n)) are configured to be unable to move relative to each other in the longitudinal, tangential, and radial directions, but to rotate relative to each other about a center of rotation. The method comprises forming the first portion (524;1124;522(n-1);1122(n-1)) and the second portion (522(1);1122(1);522(n);1122(n)) from a single cylindrical element (520;1100) by cutting a predetermined pattern from the cylindrical element, for example by laser cutting or water cutting.

[19] Inserting a further cylindrical element (500;1000;1000a) inside the single cylindrical element (520;1100), wherein the further cylindrical element (500;1000;1000a) comprises the mounting elements (502(1);1006;502(n)), Next, the pins (556(1);1156(1);556(n);1156(n)) are attached to the aforementioned portion of the mounting element (502(1);1006;502(n)), Attaching the other of the first part (524;1124;522(n-1);1122(n-1)) and the second part (522(1);1122(1);522(n);1122(n)) to another part of the mounting element (502(1);1006;502(n)), The method described in

[18] , including the method described in

[18] .

[20] While inserting the further cylindrical elements (500;1000) inside the single cylindrical element (520;1100), the pins (556(1);1156(1);556(n)) are damaged to break one or more fracture elements still attached to the surrounding material of the single cylindrical element (520;1100), the damage occurring after the pins (556(1);1156(1);556(n);1156(n)) are attached to a portion of the mounting elements (502(1);1006;502(n)), Attaching the other of the first part (524;1124;522(n-1);1122(n-1)) and the second part (522(1);1122(1);522(n);1122(n)) to another part of the mounting element (502(1);1006;502(n)), The method described in

[18] or

[19] , including the method described in

[18] or

[19] . The method according to any one of items

[18] to

[20] , including the operation of manufacturing a steerable device as described in any one of items

[15] to

[17] .

Claims

1. A steerable device, The steerable device includes a first cylindrical element (520; 1100) and a second cylindrical element (500; 820; 1000; 1000a) located inside or outside the first cylindrical element, and the steerable device has a central axis (520c; 1100c). The first cylindrical element (520; 1100) comprises a first portion (524; 522(n-1); 1122) having an opening for accommodating pins (556(1); 1156(1); 556(n); 1156(n)), The second cylindrical element (500; 1000; 1000a) comprises mounting elements (502(1); 848(n); 1006; 502(n)), The pins (556(1); 1156(1); 556(n); 1156(n)) are attached to a portion (506(1); 506(n)) of the mounting element (502(1); 848(n); 1006; 502(n)), A steerable device in which the first portion (524; 522(n-1); 1122(n-1)) and the mounting elements (502(1); 848(n); 1006; 502(n)) are configured to rotate relative to each other about a center of rotation (530(1); 1130(1); 530(n); 1130(n)).

2. The first cylindrical element (520; 1100) comprises a second portion (522(1); 1122(1); 522(n); 1122(n)) located at the same distance from the central axis as the first portion, The second portion (522(1); 1122(1); 522(n); 1122(n)) is attached to the mounting element (502(1); 1006; 502(n)), The steerable device according to claim 1, wherein the first portion (524; 1124; 522(n-1); 1122(n-1)) and the second portion (522(1); 1122(1); 522(n); 1122(n)) are configured to rotate relative to each other about the center of rotation (530(1); 1130(1); 530(n); 1130(n)).

3. The first part comprises a first rotating section portion (548(1)) having the opening, The steerable device according to claim 2, wherein the second portion comprises a second rotating section portion (550(1)) that at least partially surrounds the first rotating section portion.

4. The steerable device according to claim 3, wherein the first rotating section portion and the second rotating section portion comprise sections having complementary shapes or shapes that rotatably fit together.

5. The steerable device according to claim 3, wherein the first rotating section portion is formed as an extension portion (548(1)) having a slot (542(1)) defining the outer edge of the opening, and an island (556(1)) forming the pin is formed within the opening, and the second rotating section portion is formed by a notch (550(1)).

6. The steerable device according to claim 1, wherein the opening is a circular opening having a center forming the center of rotation, and the pins (556(1); 556(n)) are arranged within the opening so as to be rotatable about the center of rotation.

7. The steerable device according to claim 1, wherein the opening is a slot (1158(1); 1158(n)) arranged along an arc of a circle having a center forming the center of rotation, and the pin (1156(1); 1156(n)) is arranged in the slot so as to be movable within the slot along the arc of the circle.

8. The steerable device according to claim 1, wherein the mounting element is a spacer (1006) located between adjacent steering strips (1004) within the second cylindrical element, which is located inside the first cylindrical element.

9. The steerable device according to claim 1, wherein the mounting element is a spacer (1006) located between adjacent steering cables (1004a) within the second cylindrical element, which is located inside the first cylindrical element.

10. The steerable device according to claim 8, wherein the steerable device comprises a steerable distal end portion by the steering strip (1004).

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