Steerable devices including detachable parts

By designing a combination of the support unit and the steering unit, the problems of insufficient instrument maneuverability and difficulty in contamination cleaning during long-distance endoscopic examinations are solved, efficient instrument control and simplified cleaning and disinfection are achieved, and costs and risks are reduced.

CN113966189BActive Publication Date: 2025-09-16FORTIMEDIX ASSETS II BV
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Patent Information

Application Number
CN202080041773.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-10-11
Filing Date
2020-04-07
Publication Date
2025-09-16
Estimated Expiration
2040-04-07

AI Technical Summary

Technical Problem

Existing steerable instruments lack maneuverability, flexibility, and accuracy during long-distance endoscopic examinations, and are difficult to clean and disinfect after instrument contamination, leading to unexpected postoperative complications and high costs.

Method used

A steering device is designed, including a support unit and a steering unit. The bending and movement of the instrument are achieved through the rotational movement of the longitudinal element and the steering unit. A locking mechanism is used to ensure the fixation and disengagement of the longitudinal element, simplifying the connection and disconnection process.

Benefits of technology

It improves the maneuverability and flexibility of instruments in long-distance endoscopic examinations, simplifies the cleaning and disinfection process, reduces contamination risks and costs, and enables rapid replacement and reuse of instruments.

✦ Generated by Eureka AI based on patent content.

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Abstract

A steering device for connecting to an elongated instrument comprises: a support unit comprising a first channel having a first central axis, the first channel extending from a distal side to a proximal side of the support unit, wherein the support unit is arranged around the first channel; and a steering unit rotatably arranged on the support unit, the steering unit being arranged to fix / release multiple longitudinal elements of the instrument to move with the rotational movement of the steering unit.
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Description

Technical Field

[0001] The present invention relates to a steerable instrument for use in invasive and non-invasive applications, such as surgery. Such instruments can be used, for example, in gastroscopy, colonoscopy, endoscopy, laparoscopy, and other medical applications. However, steerable instruments according to the present invention can also be used in non-medical applications. Examples of the latter include inspecting and / or repairing mechanical and / or electronic hardware in difficult-to-reach locations. Background Art

[0002] The transformation of surgical interventions that require large incisions to expose the target area into minimally invasive surgical interventions, i.e., those that only require natural orifices or small incisions to establish access to the target area, is a well-known and ongoing process. When performing a minimally invasive surgical intervention, an operator, such as a physician, requires an access device that is arranged to introduce and guide an invasive instrument into the human or animal body via an access port in the human or animal body. In order to reduce scar tissue formation and pain in the human or animal patient, the access port is preferably provided through a single small incision in the skin and underlying tissue. In this regard, the possibility of using the body's natural orifices would be even better. The access device preferably enables the operator to control one or more degrees of freedom provided by the invasive instrument. In this way, the operator can perform the desired action at the target area in the human or animal body in an ergonomic and accurate manner.

[0003] Steerable surgical invasive instruments for use in the fields of gastroscopy, colonoscopy, endoscopy, laparoscopy, etc. are well known in the art. The invasive instruments may include a steerable tubular device that enhances their navigation and steering capabilities. Such a steerable tubular device may include a proximal end portion, a distal end portion including at least one deflectable region, and a rigid or flexible intermediate portion or shaft, wherein the steerable tubular device further includes a steering arrangement at its proximal end portion adapted to deflect the distal deflectable region relative to a central axis of the tubular device.

[0004] Most known devices are complex to manufacture, resulting in high costs. Typically, the distal end of the device includes a flexible zone consisting of individual links with hinge pins, coils, or flexible plastic extrusions. The steering cables must be guided through holes in these links and / or through guide eyelets or hooks.

[0005] In many prior art devices, the steering arrangement includes a conventional steering cable having a diameter of, for example, less than 1 mm as a control member, wherein the steering cable is arranged between the associated deflectable region at the distal end piece and the steering arrangement at the proximal end portion of the tubular device. Alternatively, the control member may be implemented by one or more sets of longitudinal elements, for example, formed by laser cutting of a tubular element. Further details regarding the design and manufacture of such steerable tubes and their steering arrangements are described, for example, in WO 2009 / 112060 A1, WO 2009 / 127236 A1, WO 2017 / 213491 A1, and WO 2018 / 067004. Such instruments can advantageously be used for endoscopic procedures where the length does not need to exceed, for example, 1 meter.

[0006] Sometimes, extruded plastic tubes are used with integrated channels for accommodating cables. This allows for a simpler instrument design. However, most plastics are quite fragile. Therefore, in the case of very long instruments, for example, those longer than one meter, problems can arise due to the large forces exerted on the steering and actuation cables arranged at the distal end of the instrument to operate the tool. These problems can include undesired cutting, slip-stick effects in the plastic tube, and the often excessive friction on the cables, making steering the steering cable difficult and unmanageable. Furthermore, the mechanical properties of many plastics may be too poor to ensure sufficiently high torsional stiffness, as the instrument must be able to rotate during use, and they may have to be guided through several curves that hinder the rotation of the entire instrument. Another disadvantage of plastic tubes can be that if an actuation cable is provided at the distal end of the instrument to operate the tool, the forces in the actuation cable can increase to the point where they exceed the maximum longitudinal force allowed by the extruded plastic tube. If this occurs, it becomes impossible to operate the tool with acceptable forces. Furthermore, if the plastic tube is arranged in a bend and large forces are applied to the actuating cable, the passage for the steering cable may be deformed, particularly in the bend / deflection portion, so that the steering cable is clamped and can no longer move freely, thereby preventing proper operation of the steering of the deflectable zone of the distal end.

[0007] In medical applications requiring longer instruments, such as colonoscopy, where instruments 1.5 meters (or longer) in length may be used, the requirements for maneuverability, flexibility, stiffness, and accuracy are significantly increased. It is desirable to develop such instruments that have better performance than prior art devices in terms of steerability under end effector actuation, longitudinal stiffness, torsional stiffness, durability of the mechanical actuation tool at the distal end, and adaptability.

[0008] In medical applications, contamination of instruments after they have been used to perform surgical procedures on patients can be a problem that can lead to undesirable post-operative complications. Contamination can be caused by blood, other body fluids, tissue, and more. As a result of contamination, instruments can harbor bacteria, viruses, or other biological or chemical substances that could threaten the health of the next patient to whom the instrument is applied.

[0009] One way to avoid this contamination is to thoroughly clean and sterilize the instruments before each use. In many cases, this cleaning process cannot remove all contaminants and / or is prohibitively expensive. Consequently, there is still a risk of adverse effects on patients treated with these instruments. To mitigate the risk of contamination, there is a tendency to use single-use, disposable instruments that are discarded after treating a single patient. Summary of the Invention

[0010] According to a first aspect of the present invention, a steering device for connecting to a slender instrument includes: a support unit, the support unit including a first channel having a first central axis, the first channel extending from a distal side to a proximal side of the support unit, wherein the support unit is arranged around the first channel; and a steering unit, the steering unit being rotatably arranged on the support unit, the steering unit being arranged to fix / release multiple longitudinal elements of the instrument to move with the rotational movement of the steering unit.

[0011] Such a steering device can allow for easy connection and disconnection of instruments for medical or other operations. The elongated instrument can use the longitudinal element for steering purposes, thereby allowing bending and movement controlled by the steering unit at the distal end. By having a steering unit to which the longitudinal element is fixed, the longitudinal element can be pushed or pulled for appropriate steering, and this allows for easy connection and disconnection of the instrument from the steering device. This makes it possible for even non-technical personnel to quickly, securely and easily connect the instrument to the steering device when needed. With this simple connection, the instrument can be disposable, while more complex steering device and steering unit components are reusable.

[0012] According to one embodiment, the support unit comprises a spherical element, around which the steering unit can rotate and through which the first channel extends. Such a spherical element allows the required movement of the steering unit relative to the instrument shaft while preventing any movement that could cause the longitudinal steering element to twist or become tangled.

[0013] According to one embodiment, the steering unit comprises a steering plate and one or more frames connected around one or more axes to enable movement of the steering plate in space. By enabling any movement of the steering plate, the movement of the instrument can be more precisely controlled.

[0014] According to one embodiment, the steering unit comprises a second channel, and the spherical element is arranged in the second channel, thereby allowing the steering device to control the movement of the instrument very precisely.

[0015] According to one embodiment, the steering unit includes a plurality of connectors for connecting the plurality of longitudinal elements to the steering unit, thereby enabling the push and pull movement performed by the steering device for very precise control of the movement of the instrument. The plurality of connectors may include a plurality of openings located in the steering unit and configured to receive a longitudinal element, wherein the plurality of openings may be of any suitable number and have any suitable shape. The plurality of connectors may include a plurality of grooves extending inwardly from the circumference of the steering unit. This allows easy attachment and detachment of the longitudinal element from the steering device.

[0016] According to one embodiment, the plurality of connectors may comprise a plurality of arm-like elements extending outwardly from the steering member unit. The arm-like elements may be easily connected to and disconnected from the instrument by, for example, providing the longitudinal element of the arm-like elements which can be introduced into the instrument and end pieces or any other suitable parts which can be extracted therefrom.

[0017] According to one embodiment, the steering device further comprises a locking mechanism for securing the longitudinal element to the steering unit. This allows preventing accidental removal of the longitudinal element during use by locking the locking mechanism and easily releasing the device from the steering unit by opening the locking mechanism.

[0018] According to one embodiment, the locking mechanism includes a locking plate configured to secure the plurality of longitudinal elements to the steering unit, wherein the plurality of longitudinal elements are secured to the steering unit through a plurality of openings, and the locking plate is connected to the steering unit such that the locking plate prevents the plurality of longitudinal elements from exiting the plurality of openings. Furthermore, the locking plate may be movable from an open position, in which the longitudinal elements can be inserted into or removed from the openings, to a locked position, in which the longitudinal elements are secured within the openings. This is an advantageous means of allowing attachment and detachment of the instrument from the steering device.

[0019] The locking plate may be axially movable to secure the longitudinal element in an opening extending inwardly from the circumference of the steering unit. Furthermore, the locking plate may be rotationally movable to move from the open position to the locked position.

[0020] In another embodiment, the locking plate includes a plurality of protruding elements extending around its outer circumference, wherein each of the protruding elements includes a hooked side arranged to receive a longitudinal element in the channel to secure the longitudinal element. In this manner, the longitudinal element can be easily secured by rotating the locking device in the correct direction. Instead of a hooked side, the protruding elements may have any other shape that allows the longitudinal element to be secured in the channel. The protruding elements may include an angled side arranged opposite the channel so that when the locking plate is rotated from the locked position, in which the longitudinal element is secured in the channel, to the open position, the longitudinal element slides over the angled side of the protruding element and is thereby pushed out of the plurality of openings. This provides a very simple and advantageous means of releasing the instrument from the steering device. The steering device may be arranged such that, when the plurality of elongated elements are secured to the steering unit, rotational movement of the steering unit about the support unit causes the steering unit to push and / or pull the plurality of elongated elements.

[0021] According to one embodiment of the present invention, a slender instrument for connecting to a steering device includes: a slender shaft having a distal end and a proximal end; and a plurality of slender elements extending along the shaft, wherein each of the plurality of slender elements includes a connecting part for fixing the slender instrument to the steering device.

[0022] According to one embodiment of the present invention, the plurality of longitudinal elements are arranged to extend outwardly from the elongated shaft. This provides the advantage of easily connecting the instrument from the steering device, as the longitudinal elements are already arranged in the correct attachment position. Furthermore, the longitudinal instrument may include a tapered device located at the proximal end, configured to push the longitudinal elements apart for extending outwardly from the elongated shaft. This allows the longitudinal elements to remain in the correct attachment position.

[0023] According to an embodiment of the present invention, the connecting part of the elongated instrument may comprise an opening. This allows the connection and disconnection of the instrument and the steering device, since an arm-like element or any other suitable shaped element of the device steering device can be inserted into or withdrawn from the opening of the elongated element.

[0024] The elongate instrument comprises a tube, and wherein the plurality of longitudinal elements are produced by laser or water cutting a plurality of longitudinal slots in the tube.

[0025] Embodiments of the invention are claimed in the dependent claims.

[0026] By the description of the present invention of non-limiting and non-exclusive embodiments, other features and advantages of the present invention will become apparent. These embodiments should not be interpreted as limiting the scope of protection. Those skilled in the art will recognize that, without departing from the scope of the present invention, other alternatives and equivalent embodiments of the present invention can be conceived and reduced. In addition, even if not clearly shown in the drawings or explained in the specification, the individual features of different embodiments also can be combined, unless such combination is physically impossible. The scope of the present invention is limited only by the claims and their technical equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention will be discussed in more detail below with reference to the accompanying drawings, in which like or identical reference numerals designate like, identical or corresponding parts, and in which:

[0028] Figure 1 An apparatus according to one embodiment of the invention is shown.

[0029] Figure 2 Show Figure 1 An apparatus wherein the longitudinal element is arranged to extend outwardly.

[0030] Figure 3 and Figure 4 Show Figure 2 An alternative structure of the embodiment of the present invention.

[0031] Figure 5 An apparatus and a steering device according to one embodiment of the invention are shown.

[0032] Figure 6 Shown coupled to each other Figure 5 equipment and steering devices.

[0033] Figure 7 Show Figure 5 An alternative structure of a steering device.

[0034] Figure 8A and Figure 8B Shown also includes a locking mechanism Figure 6 equipment and steering devices.

[0035] Figure 9A 、 Figure 9B and Figure 9C An alternative arrangement of the locking mechanism of FIG. 8 is shown in three different positions.

[0036] FIG. 10A to FIG. 10B An embodiment of a steering device is shown having an implement coupled to the steering device.

[0037] FIG. 10C to FIG. 10D Show FIG. 10A to FIG. 10B A cross-sectional view of the coupling shown in FIG.

[0038] Figures 11A to 11C Another embodiment of a steering device having an implement coupled to the steering device is shown.

[0039] Figure 12 The complete instrument with the steering device is shown, connected and with distal end deflection. DETAILED DESCRIPTION

[0040] The same reference numerals will be used in different drawings to designate the same elements.

[0041] Figure 1 A non-limiting embodiment of an instrument 100 is shown, comprising a plurality of longitudinal elements 102 arranged about a central axis 103 of the instrument 100. The instrument 100 is schematically shown to represent any steerable instrument for use in medicine or other surgery. Suitable instrument arrangements can be found in NL2021823, filed October 16, 2018, entitled "Steerable instrument comprising a tube element," which is incorporated herein by reference. Figure 1 The longitudinal elements 102 shown are realized by longitudinal strip elements in the tube element and are separated by longitudinal slots 104 produced by laser cutting in a cylindrical tube as explained, for example, in WO 2009 / 112060 A1, WO 2009 / 127236 A1, WO 2017 / 213491 A1 and WO 2018 / 067004 or by rigid cables or wires.

[0042] These longitudinal slots 104 extend through the entire thickness of the material. As an alternative to laser cutting, other techniques can be used, such as cutting with a water jet. Furthermore, other methods such as 3D laser printing can be used. These slots extend through the entire thickness of the material. This also applies to the other embodiments discussed below with reference to laser cutting.

[0043] The longitudinal element 102 includes a T-shaped connecting feature 108 at a proximal end 106 of the instrument 100 , which may be achieved by laser cutting a rectangular slot 110 at the proximal end 106 of each longitudinal slot 104 . Figure 1 The illustrated instrument 100 also includes at least one distal deflectable region ( Figure 1 ), wherein the longitudinal element 102 is connected to the distal deflectable region ( Figure 1 (not shown) so that by pulling or pushing the longitudinal element 102, the distal deflectable region is controlled to deflect in a desired direction. Figure 1A tool (not shown in FIG) (like forceps or any other kind of suitable tool) may be arranged at said distal end of the instrument 100 . Figure 1 The device 100 shown may further include an outer tube 112 that partially or completely covers the longitudinal element 102. In addition, the device 100 may further include a shaft ( Figure 1 not shown).

[0044] Figure 2 Show Figure 1 A non-limiting embodiment of an instrument is shown in which the longitudinal element 102 is arranged to extend outwardly from the shaft 202 at the proximal end 106 of the instrument 200. The longitudinal element 102 may be arranged to extend outwardly by being manually bent or by any other suitable means.

[0045] Figure 3 Show Figure 2 An alternative non-limiting embodiment of the instrument is shown, in which the instrument 300 includes a device 302 arranged about the shaft 202, wherein the device 302 includes a proximal end 304 and a distal end 306, wherein the proximal end 304 includes a cylindrical shape and the distal end 306 includes a tapered shape such that the tapered shape is arranged to urge the longitudinal element 102 outward from the shaft 202.

[0046] Figure 4 Show expansion Figure 2 Alternative exemplary approach to the longitudinal element of the illustrated instrument. The longitudinal element 102 is arranged to extend outwardly from the central axis 103 of the instrument 400 through a cone 402, wherein the cone 402 is arranged about the shaft 202 such that the longitudinal element 102 is deployed through the outer surface of the cone 402.

[0047] It will be appreciated that any other suitable device or method may be used to arrange the longitudinal element at the proximal end such that the longitudinal element extends outwardly from the central axis of the instrument.

[0048] Figure 5 The steering device 500 is shown with an implement connected thereto, according to one embodiment.

[0049] The steering device 500 includes a support unit 502 and a steering unit 504. The support unit 502 includes a bulbous element 506 traversed by a first channel 508, wherein the first channel 508 has a circular shape and extends from a proximal end 510 of the steering device 500 to a distal end 512 of the steering device 500. The first channel 508 extends from the bulbous element 506 at the proximal end of the steering device 500, thereby defining a hollow tube 514 extending outwardly from the bulbous element.

[0050] The steering unit 504 includes a steering plate 516 and a second channel 518 located at the center of the steering plate 516 , wherein the second channel 518 includes a circular shape.

[0051] The support unit 502 is arranged in the second channel 518 such that the deflection unit 504 can rotate around the spherical element 506 and such that the central axis 520 of the first channel 508 coincides with the central axis 530 of the second channel.

[0052] The deflector plate 516 also includes a plurality of grooves 532 extending inwardly from the circumference of the deflector unit of the deflector plate 516 , wherein the grooves 532 have a U-shape, but may take a variety of different shapes in different embodiments.

[0053] The steering device 500 is arranged to be attached to the instrument 200 in the following manner. Each slender element includes a connecting part 509 that can be fitted into the groove 532 and fixed in the groove 532. In this case, the T-shaped connection is formed to have a narrower part to enter the groove and a wider part at the end to ensure that no longitudinal movement of the slender element is allowed once connected. The inner shaft 406 of the instrument is introduced into the side of the first channel 504 of the support member 502 located at the distal end of the steering device 500 so that the central axis 409 of the instrument coincides with the central axis 520 of the first channel 508 and so that the connecting part 509 of the longitudinal element 408 is aligned with the groove 532. The connecting part 509 of the longitudinal element 408 is then pushed into the groove so that the upper wider part of the T is fixed at the proximal side of the steering plate, as shown Figure 6 shown.

[0054] like Figure 6 It can be seen that by moving the steering plate 516 around the ball-shaped element 506, the longitudinal element 408 is pushed or pulled by the steering plate 516, thereby causing distal deflection ( Figure 6 not shown).

[0055] Figure 7 Show Figure 5 An alternative embodiment of the steering device 500 is shown in FIG. 5 , wherein the steering plate 516 includes a plurality of openings 702 rather than circumferential grooves. The manner of attaching the instrument to the steering device 700 is similar to that of the reference embodiment. Figure 5 In the manner explained above, in this embodiment, the connecting parts 108 of the longitudinal elements are pushed against the openings so that they "snap" into the receiving portions of the receiving portion deflector plate 516. As can be seen in this embodiment, the connecting portions snap into complementary shaped receiving portions in the deflector plate 516, with the central opening and the ramp guiding the snap feature (here, the wider "top" of the connecting portion 509) into a fixed position.

[0056] Figure 8A and Figure 8B Show Figure 6 An embodiment further comprising a locking mechanism in the form of a locking plate 804.

[0057] Figure 8A and Figure 8B The locking mechanism 802 is shown in an open position ( Figure 8A shown) and closed position ( Figure 8B Move between the

[0058] from Figure 8A As can be seen in FIG, the steering device 500 and the instrument 200 are coupled to each other so that the elongated element 102 is placed in the groove 532, as already mentioned with reference to FIG. Figure 5 Explained. Figure 8A Also shown is a locking mechanism 802 for securing the longitudinal element 102 to the steering unit 504, wherein the locking mechanism 802 is in an open position, such that the longitudinal element 102 can be inserted into or removed from the groove 532. The locking mechanism 802 includes a locking plate 804 having a circular shape and an opening in the center thereof, such that the tube 514 of the support unit 502 can pass through the opening. The locking plate 804 can be axially moved from the open position, in which the longitudinal element is removed from the groove, to a locked position, in which the longitudinal element is secured within the groove. For example, the locking plate 804 can be moved toward or away from the steering device 500 along a central axis 806 and / or can be moved in a rotational manner.

[0059] Figure 8B Show Figure 8A An embodiment in which the locking mechanism has been removed by moving the locking plate axially toward the steering device Figure 8A The open position shown moves to Figure 8B This movement continues until the locking plate 804 engages the steering plate 516 and / or the connecting feature 509 of the longitudinal element, thereby preventing the longitudinal element from being removed from the groove 532 or the opening 702. The locking mechanism and / or plate 804 can have a variety of different shapes, as long as it can be quickly and securely coupled to the steering plate 516 to ensure that the longitudinal element is fixed to the steering plate 516.

[0060] Figure 9A 、 Figure 9B and Figure 9C An alternative arrangement to the locking mechanism of FIG. 8 is shown.

[0061] Figure 9A 、 Figure 9B and Figure 9CThe illustrated locking mechanism 1000 includes a locking plate 1002. The locking plate 1002 includes an opening arranged so that the locking plate 1002 can be rotatably mounted relative to the steering plate 516. The locking plate 1002 includes a plurality of protruding elements 1004 extending around the outer circumference of the locking plate. Each protruding element 1004 includes a hooked side 1006 that forms a channel and an angled side 1008.

[0062] Figure 9A The locking mechanism 1000 is shown in a position where each longitudinal element 102 is located between the hook side 1006 of the protruding element and the angled side of the adjacent protruding element so that the longitudinal element 102 can be removed from the groove 532 of the diverter plate 516.

[0063] The locking plate 1002 is configured to Figure 9A The open position shown is rotated axially clockwise to Figure 9B Shown in locked position. Figure 9A The locking plate 1002 is shown rotated axially clockwise such that the hooked side of each of the protruding elements moves toward the corresponding elongated element 102 until the elongated element is located inside the channel 1010 defined by the hooked side, thereby achieving Figure 9B Shown is a locked position in which the longitudinal element 102 is fixed in the channel 1010 .

[0064] Figure 9C Shown after clockwise axial rotation from the locked position to the disengaged position in which the longitudinal element has been removed from the groove Figure 9B By axially rotating the locking plate counterclockwise, the inclined side of each of the protruding elements moves toward the corresponding longitudinal element 102 so that the elongated element slides on the inclined side and is pushed out of its corresponding groove by the inclined side 1008, thereby reaching Figure 9C Shown is a separated position in which the longitudinal element 102 is located outside the groove.

[0065] 10A to 10D Another embodiment according to the present invention is shown comprising an instrument 1100 , a steering device 1101 , and a locking mechanism 1103 . Figure 10A and Figure 10B Shown where the locking mechanism is Figure 10A In the open position is not fully in Figure 10B The coupled implement and steering device are in the closed position. Figure 10C and Figure 10D A cross-sectional view is shown of the instrument 1100 and the steering device coupled together.

[0066] 10A to 10D Shown with Figure 1An instrument 1100 is similar to the instrument in FIG, wherein the connecting part 1104 of the longitudinal element 1102 has a circular shape instead of a T-shape.

[0067] 10A to 10D The locking mechanism 1103 shown includes a locking mechanism having a Figures 9A to 9C The locking mechanism 1103 comprises a slot for receiving the connecting portion 1104 or the longitudinal element 1102. The longitudinal element 1102 can slide into place by following the curvature of the tapered section 1106 leading to the receiving groove 1108. Figure 10C As can be seen in FIG, when in the open position, the tapered section 1106 moves closer to the locking mechanism 1103. This allows for easier insertion (and removal) of the elongated element into the groove 1108. When the elongated element 1102 is secured in the groove, the locking mechanism 1103 rotates to secure the elongated element in place in the groove. This is Figure 10A and Figure 10D 101. This rotational movement to the locked position also extends the tapered section 1106 axially relative to the locking mechanism 1103. This ensures proper tensioning of the elongated element to ensure proper bending and deflection of the instrument. The instrument can be easily removed in the same steps, namely rotating the locking mechanism 1103 and then pulling the instrument axially away from the steering device 1101. When the locking mechanism 1103 is rotated to the open position, as shown in FIG. Figure 10B As seen in FIG, elongate element 1102 is pushed from groove 1108 to facilitate detachment of the instrument from the steering device. Rotation may be performed manually, for example by using a grip portion, or may be automated.

[0068] Figures 11A to 11C An alternative arrangement of an implement and a steering device according to another embodiment of the present invention is shown.

[0069] The instrument 1202 includes an outer tube 1206 covering a longitudinal element 1200. The outer tube 1206 includes a plurality of openings 1208. The longitudinal element 1200 of the instrument 1202 also includes a plurality of openings 1204 that overlap with the openings 1208 of the outer tube 1206. The openings 1208 of the outer tube and the openings 1204 of the longitudinal element 1200 can be produced by laser cutting in corresponding cylindrical tubes.

[0070] These openings 1204 and 1208 extend through the entire thickness of the material. As an alternative to laser cutting, other techniques can be used, for example, cutting by a water jet. In addition, other methods such as 3D laser printing can be used.

[0071] Figure 11BThe instrument 1202 and the steering device 1210 are shown, wherein the steering device 1210 and the instrument 1202 are separated. The steering device 1210 includes a steering unit 1212 and a support unit 1214, wherein the steering unit 1212 is rotatably mounted on the support unit 1214, which is similar to Figure 5 The support unit 502 and the steering unit 504. The steering unit 1212 includes a plurality of arm members 1216 fixedly connected to the steering unit 1212 and extending outwardly from the steering unit for connecting the plurality of longitudinal members 1208 to the steering unit 1212.

[0072] Figure 11C Show Figure 11B The instrument 1202 and the steering device 1210 are connected together by inserting the end portion of the arm-like element 1216 into the opening 1204 of the longitudinal element 1200, so that by steering the steering unit 1212 around the support unit 1214, the arm-like element 1216 pulls or pushes the longitudinal element 1200 for controlling the distal end ( Figure 12 A to Figure 12 C not shown).

[0073] Figure 12 An example of deflection of the steering plate 1300 is shown, which causes deflection of the distal end 1305 of the instrument 100. Actuator 1301 is connected to the inner frame 1304 about a hinge axis 1303. Other embodiments may include another frame with another hinge axis. To achieve any movement of the steering plate 1300 in space, the steering unit can be controlled manually, robotically, or a combination of both. Actuator 1301 moves the inner frame 1304 so that the distal end deflects in a specific direction. This causes tensioning of some longitudinal elements and relaxation of other longitudinal elements, thereby causing deflection at the distal end. Some embodiments may include longitudinal elements connected differently at the distal end (e.g., rotated 180 degrees) so that they cause opposite deflections of the distal end for the same movement depicted in the steering unit 1308.

[0074] like Figure 12 As can be seen in the figure, the suspension and control of the steering device 1308 can be complex in order to achieve movement in any three-dimensional plane and rotational movement of the steering plate 1300, and therefore any bending or rotation of the instrument 100. By using a steering plate 1300 to which the longitudinal element 1302 of the instrument is fixed, and providing a quick but simple and secure connection with the locking plate, the steering device 1308 can be reused while achieving a disposable instrument. This enables more complex steering devices 1308, which are particularly useful in robotic applications.

[0075] The various steerable instruments described in various embodiments may include manual operation (see Figure 12 ), or may include a handle arranged at the proximal end of the instrument for steering the distal end of the instrument and / or for manipulating the tool. Such a tool may be, for example, a camera, a manual manipulator, such as a pair of scissors, or a manipulator using energy (such as electrical, ultrasonic or optical energy). The type of tool applied to the distal end of the instrument is not limited. The type of handle or robotic steering unit and / or connection will depend on the type of tool applied to the distal end, the intended use, and other instrument or operating requirements.

[0076] Furthermore, the steering unit has been described as being spherical, but may be shaped differently in different embodiments. In some embodiments, the steering plate of the steering unit may be connected in different ways (e.g., directly to a channel or locking plate) and / or may not include a support member. The longitudinal elements may be connected to different parts of the steering unit and in a variety of different ways, typically circumferentially around the steering unit. Different devices may include different numbers of longitudinal elements, depending on the desired deflection capability.

[0077] Any number of deflection or bending zones can be included by using an appropriate number of longitudinal elements and connecting them at appropriate locations along the length of the instrument. The distal end 1305 and the longitudinal elements can be made by laser cutting the same longitudinal tube. The distal end can have any number of bendable zones.

[0078] When the operation or procedure is completed, the instrument 100 can be easily and quickly disconnected from the steering device, as has been explained with respect to several embodiments.

[0079] The instrument 100 can then be discarded, with the diverter device being available for use with a new, clean instrument 100 for further operation. In some embodiments, the instrument 100 can be sent for cleaning and disinfection in preparation for reuse. In such embodiments, the ability to disconnect the portion that needs cleaning can help ensure that proper cleaning and disinfection can be completed. For example, a disconnected instrument can be placed in a sanitary treatment room, while an undisconnected instrument may not be placed in a sanitary treatment room due to size and / or other sensitive components.

[0080] As discussed in the background, reusable instruments in the past required extensive cleaning and decontamination operations before they could be safely reused. This is a time-consuming process that does not always eliminate all contaminants. Some steerable instruments are disposable to avoid the time, cost, and risk of attempting to clean, but it is quite expensive to dispose of the complete instrument after each operation. By using a steering device that can be connected to and detached from the instrument 100 in a quick, easy, and safe manner, only the contaminated portion of the instrument can be discarded (or cleaned and sterilized in some cases), and the other parts can be safely reused without the need for extensive decontamination processes. Since the steering portion of such instruments may be a complex and relatively expensive part, it is possible to detach the exposed portion of the instrument from the steering portion, and only disposing of the exposed portion has great economic benefits and results in less waste. A quick and simple connection between the steering plate and the steering device is used to enable the disposable instrument 100 to be quickly connected and disconnected from the disposable steering device at the use location and performed by untrained or unskilled personnel.

[0081] WO 2009 / 112060 A1, WO 2009 / 127236 A1, WO 2017 / 213491 A1 and WO 2018 / 067004 show embodiments in which the present invention can be applied and are hereby incorporated herein by reference.

[0082] The device 100 can be manufactured such that the longitudinal elements 1302 are formed in the tube by longitudinal strip elements separated by longitudinal slots created by laser cutting in the cylindrical tube, and the bendable part of the distal end can be formed by laser cutting in the same tube, as explained in detail in, for example, WO 2009 / 112060 A1, WO 2009 / 127236 A1, WO 2017 / 213491 A1, and WO 2018 / 067004. As an alternative to laser cutting, other techniques can be used, such as cutting with a water jet. In addition, other methods such as 3D laser printing can be used. These slots extend through the entire thickness of the material. This also applies to the other embodiments discussed above.

[0083] The examples and embodiments described herein illustrate, not limit, the present invention. Elements from different embodiments may be combined to form embodiments not shown in the figures, unless such combinations are incompatible. Those skilled in the art will be able to design alternative embodiments without departing from the scope of the claims. Reference signs placed between parentheses in the claims should not be construed as limiting the scope of the claims. Items described as separate entities in the claims or the specification may be implemented as a single item or multiple hardware items combining the features of the items.

[0084] It should be understood that the present invention is limited only by the appended claims and their technical equivalents. In this document and its claims, the verb "to include" and its variants are used in its non-restrictive sense to mean that the items following the word are included, but items not specifically mentioned are not excluded. In addition, an element referenced by the indefinite article "a" or "an" does not exclude the possibility that there is more than one of the element, unless the context clearly requires the presence of one and only one of the element. Thus, the indefinite article "a" or "an" generally means "at least one".

Claims

1. A steering device (500; 700; 1200) for connection to an elongated instrument, comprising: A support unit (502) arranged around a first channel (508) having a first central axis, the first channel (508) extending from a distal side to a proximal side of the support unit; as well as A steering unit (504) rotatably arranged on the support unit (502), the steering unit (502) being arranged to fix / release a plurality of longitudinal elements (102; 1102; 1302) in a tube of an instrument, the plurality of longitudinal elements being made by cutting a plurality of narrow slots (104), the plurality of longitudinal elements being provided with connecting parts (108; 1104; 1204) in the form of wider portions (108; 1104) at their ends, the steering unit comprising a plurality of grooves (532) or a plurality of openings (702) extending inwardly from the circumference of the steering unit (504), each groove or opening being configured to receive one longitudinal element (102) and fix / release the wider portion (108; 1104) of one of the plurality of longitudinal elements (102; 1102; 1302) so that the longitudinal elements can move with the rotational movement of the steering unit (504).

2. The steering device (500; 700; 1101; 1308) of claim 1, wherein the support unit (502) comprises a spherical element (506), such that the steering unit (504) is rotatable around the spherical element (506) and the first channel (508) extends through the spherical element (506).

3. The steering device (500; 700; 1101; 1308) of claim 1, wherein the steering unit (504) comprises a steering plate (516).

4. A steering device (500; 700; 1308) as described in claim 3, wherein the steering plate (516) includes a plurality of grooves (532), and the steering device further includes a locking mechanism (804; 1002; 1103) for fixing the plurality of longitudinal elements (102; 1102; 1302) to the steering unit (504).

5. The steering device (500; 700; 1302) of claim 4, wherein the locking mechanism comprises a locking plate (804; 1002) for securing the plurality of longitudinal elements (102; 1102; 1302) to the steering unit (504).

6. A steering device (500; 700; 1302) as claimed in claim 5, wherein the plurality of longitudinal elements (102; 1102; 1302) can be fixed to the steering unit (504) by means of the plurality of grooves (532) and the locking plate (804; 1002) is connected to the steering unit such that the locking plate can prevent the plurality of longitudinal elements from exiting the plurality of grooves.

7. A steering device as claimed in claim 6, wherein the locking plate (804; 1002) is capable of moving from an open position in which the longitudinal element can be inserted into or removed from the groove (532) to a locked position in which the longitudinal element is fixed in the groove (532).

8. The steering device of claim 7, wherein the locking plate (804) is axially movable to secure the longitudinal element in a groove (532) extending inwardly from the circumference of the steering unit.

9. The steering device of claim 7, wherein the locking plate (1002) is rotationally movable to move from the open position to the locked position.

10. The steering device of claim 9, wherein the locking plate (1002) comprises a plurality of protruding elements (1004) extending around an outer circumference of the locking plate, wherein each of the plurality of protruding elements comprises a hooked side arranged to receive a longitudinal element in a channel to secure the longitudinal element.

11. A steering device as claimed in claim 10, wherein each of the protruding elements (1004) includes an inclined side, which is arranged opposite to the channel so that when the locking plate is rotated from the locked position in which the longitudinal element is fixed in the channel to the open position, the longitudinal element slides on the inclined side of the protruding element and is thereby pushed out of the multiple openings.

12. Steering device according to claim 1, wherein the steering device is arranged such that when the plurality of longitudinal elements are fixed to the steering unit, a rotational movement of the steering unit about the support unit will cause the steering unit to push and / or pull the plurality of longitudinal elements.

13. Steering device as claimed in any of the preceding claims, further comprising a guide element for guiding the plurality of longitudinal elements into a fixed position in the steering unit.

14. An elongate device for connection to a steering device, the device comprising: a tube having a distal end and a proximal end; as well as A plurality of longitudinal elements (102; 1102; 1302), said plurality of longitudinal elements extending along said tube and being made by cutting a plurality of slots (104) in said tube, wherein each of said plurality of longitudinal elements comprises at said proximal end a connecting part (108; 1104; 1204) for securing said elongated instrument to said steering device, said connecting part having In the form of a wider portion (108; 1104) at the end of the longitudinal element, it is configured to be received in one of a plurality of grooves (532) extending inwardly from the circumference of the steering unit (504) or in a plurality of openings (702), each groove or opening being configured to secure / release the wider portion (108; 1104) of one of the plurality of longitudinal elements (102; 1102; 1302) so that the longitudinal element can move with the rotational movement of the steering unit (504).

15. The elongate instrument of claim 14, wherein the plurality of longitudinal elements are arranged to extend outwardly from a central axis (103; 806) of the tube at a proximal end of the tube.

16. The elongated instrument of claim 15, further comprising a tapered device (402; 1106) at the proximal end configured to push the longitudinal element outwardly from the tube.

17. The elongate instrument of any one of claims 14 to 16, wherein the slot in the tube is made by laser or water cutting.

18. A medical device comprising an elongate instrument according to any one of claims 14 to 17 and a steering device according to any one of claims 1 to 13.

Citation Information

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