The present invention relates to a steerable instrument for endoscopic and/or invasive type of applications, such as in surgery. The steerable instrument according to the invention can be used in both medical and non-medical applications. Examples of the latter include inspection and/or repair of mechanical and/or electronic hardware at locations that are difficult to reach. Hence, terms used in the following description such as endoscopic application or invasive instrument, must be interpreted in a broad manner.
Transformation of surgical interventions that require large incisions for exposing a target area into minimal invasive surgical interventions, i.e. requiring only natural orifices or small incisions for establishing access to the target area, is a well-known and ongoing process. In performing minimal invasive surgical interventions, an operator such as a physician, requires an access device that is arranged for introducing and guiding invasive instruments into the human or animal body via an access port of that body. In order to reduce scar tissue formation and pain to a human or animal patient, the access port is preferably provided by a single small incision in the skin and underlying tissue. In some applications, a natural orifice of the body can be used as an entrance. Furthermore, the access device preferably enables the operator to control one or more degrees of freedom that the invasive instruments offer. In this way, the operator can perform required actions at the target area in the human or animal body in an ergonomic and accurate manner with a reduced risk of clashing of the instruments used.
Surgical invasive instruments and endoscopes are well-known in the art. Both the invasive instruments and endoscopes can comprise a steerable tube that enhances its navigation and steering capabilities. Such a steerable tube may comprise a proximal end part including at least one flexible zone, a distal end part including at least one flexible zone, and an intermediate part, wherein the steerable tube further comprises a steering arrangement that is adapted for translating a deflection of at least a part of the proximal end part relative to the intermediate part into a related deflection of at least a part of the distal end part. Alternatively, the distal flexible zone may be steered by a robotic instrument arranged at the proximal end of the steerable instrument.
Steerable invasive instruments may comprise a handle that is arranged at the proximal end part of the steerable tube for steering the tube and/or for manipulating a tool that is arranged at the distal end part of the steerable tube. Such a tool can for example be a camera, a manual manipulator, e.g. a pair of scissors, forceps, or manipulators using an energy source, e.g. an electrical, ultrasonic or optical energy source.
Furthermore, such a steerable tube may comprise a number of co-axially arranged cylindrical elements including an outer cylindrical element, an inner cylindrical element and one or more intermediate cylindrical elements depending on the number of flexible zones in the proximal and distal end parts of the tube and the desired implementation of the steering members of the steering arrangement, i.e. all steering members can be arranged in a single intermediate cylindrical element or the steering members are divided in different sets and each set of steering members is arranged, at least in part, in a different or the same intermediate cylindrical element.
In most prior art devices, the steering arrangement comprises conventional steering cables with, for instance, sub 1 mm diameters as steering members, wherein the steering cables are arranged between related flexible zones at the proximal and distal end parts of the tube. Other steering units at the proximal end, like ball shaped steering units or robot driven steering units, may be applied instead.
However, as steering cables have many well-known disadvantages, for some applications one may want to avoid them and to implement the steering members by one or more sets of steering wires that form integral parts of the one or more intermediate cylindrical elements. Each of the intermediate cylindrical elements including the steering wires can be fabricated either by using a suitable material addition technique, such as injection molding or plating, or by starting from a tube and then using a suitable material removal technique, such as laser cutting, photochemical etching, deep pressing, conventional chipping techniques such as drilling or milling or high-pressure water jet cutting systems. Steering wires manufactured in that way are, then, implemented as longitudinal strips resulting from the tube material, and can be used as pulling/pushing wires. Of the aforementioned material removal techniques, laser cutting is very advantageous as it allows a very accurate and clean removal of material under reasonable economic conditions.
The inner and outer cylindrical elements may be manufactured from tubes too. These tubes should be flexible at locations where the distal end, and possibly the proximal end too, of the instrument is bendable. Also at other locations where the instrument should be flexible, the inner and outer cylindrical elements should be flexible. This can be implemented by providing the inner and outer cylindrical elements with hinges at these flexible locations. Such hinges may result from (laser) cutting predetermined patterns in the tube. Many different patterns are known from the prior art. Which pattern to use depends on design requirements at the location concerned including but not limited to the required bending angle, bending flexibility, longitudinal stiffness, and radial stiffness.
Further details regarding the design and fabrication of the abovementioned steerable tube and the steering arrangement thereof have been described for example in WO 2009/112060 A1, WO 2009/127236 A1, U.S. Pat No. 13/160,949, and U.S. Pat. No. 13/548,935 of the applicant, all of which are hereby incorporated by reference in their entirety.
As is known from for example a flexible endoscopic instrument with a steerable tip, flexible invasive steerable instruments can show performance flaws with respect to steerable tip control. When such a flexible instrument is inserted into a body through a curved channel, either an endoscope or a natural body lumen, bending of the instrument causes displacement of the longitudinal tip steering elements. Because in conventionally built instruments the steering elements, e.g. wires, are fixed to a steering device, like a handle, at the proximal side and to the steerable tip at the distal side, movement of the steering wires will result in deflection of the steering device and or deflection of the steerable tip. This causes the problem that when the instrument is advanced through a narrow curved channel, and when one holds the steering device in a fixed position, the tip will deflect uncontrollable during advancement and can either lock up in, for example, a narrow endoscope working channel or it can damage tissue in for example a soft tissue natural body lumen like the lung bronchi or the esophagus.
Another problem is that when the instrument passed the entrance channel and the instrument tip reached the targeted operation site, the tip deflection does not match the steering device deflection anymore. So a neutral position of the steering device does not result in a neutral position of the steerable tip. This offset does adversely affect eye-hand coordination of the user.
Yet another problem with flexible steerable instruments is that when the tip is steered with the steering elements, also the body will be steered by the steering elements because the whole body, mechanically, behaves like a steerable tip. The ratio of deflection between the body and tip deflection merely depends on the bending stiffness of the body and the tip. The stiffer the body is with respect to the stiffness of the tip, the more the tip will be steered. In practice, the tip is more flexible than the body, but still there is a tendency that steering the tip will result also in body deflection which on its turn will result in side forces on the surrounding channel that tends to keep the instrument body in a certain curvature. If the surrounding channel exists of soft body tissue, this is a strongly unwanted instrument behaviour, since the side forces might damage the surrounding tissue. Also body movement might disturb the positioning of the steerable tip at the target site and makes accurate and predictable tip steering more difficult.
A partial solution to this problem that addresses the problem of unwanted tip steering due to bending of the instrument body is described in WO2014/011049. This solution describes an instrument in which the steering wires can be de-coupled from the steering device and the ends of these steering wires and hence the instrument tip can move freely when the instrument is advanced through a curved entrance path. Once the instrument tip passed the entrance channel and is at the targeted operation site, the steering wires are re-coupled to the steering device and the instrument tip can now be steered. The disadvantages of this solution are that the instrument is mechanically more complex and requires more parts to build. Another disadvantage is that the operator has to follow a certain procedure for passing the curved entrance channel with which he can make mistakes or which he might forget to perform. Yet another disadvantage is that the problem of body steering (side forces) is still not addressed.
Prior art solutions have in common that they are built from specially fabricated tubings, coils and machined parts and that assembly of such instruments is usually a time consuming and difficult process. Also tolerances of the separate parts add up in the assembly and can be the cause of a wide spread in for example instrument performance, often requiring an individual calibration of each instrument.
It is an object of the invention to provide a steerable instrument for endoscopic and/or invasive type of applications where at least one of the above mentioned problems are solved or at least reduced.
To that end, independent aspects of the invention are defined in independent claims whereas dependent claims relate to advantageous embodiments.
Some embodiments comprise a Bowden cable arrangement.
In this application, the terms “proximal” and “distal” are defined with respect to an operator, e.g. a robot or physician that operates the instrument or endoscope. For example, a proximal end part is to be construed as a part that is located near the robot or physician and a distal end part as a part located at a distance from the robot or physician, i.e., in the area of operation.
In many embodiment, the invention comprises an instrument having the same and improved performance as prior solutions, but which is built with significantly less separate parts and significantly less assembly effort. All the necessary elements to construct a steerable instrument, including a Bowden-cable construction may be integrally manufactured, in a largely pre-assembled state, from a number of tubes. The only remaining assembly steps consist of sliding the tubes into each other and attach the tubings to each other in the required places. The preassembled parts can be made in a tube wall by material deposition processes like 3D printing or plating techniques. Preferably the preassembled parts can be made by material removal processes from a solid wall metal or plastic tube (stainless steel, cobalt chromium alloys, super-elastic alloys like nitinol, etc). The material removal processes that can be used are for example conventional chipping processes, water jet cutting, etching and preferably laser cutting processes.
Therefore, those embodiments of this invention enable a significant reduction of manufacturing costs of such instruments and therefor the costs of an intervention in which these instruments are used. It even becomes commercially viable to use these instruments only once, and then throw them away. This increases the safety of an intervention because one can now use new instruments instead of pre-used and re-sterilized instruments that are known to have a 10% risk of post procedural complication due to contaminating or infecting the patient with not properly cleaned or re-sterilized pre-used instruments.
Another advantage of such an instrument is that by using this integrated way of producing parts in a pre-assembled state, that they always fit to each other and that minimal play between the parts can be achieved. This is especially true when a laser cutting process is used. The minimal achievable play between two integrally manufactured parts is as low as the width of the used laser beam, which can be as small as 0.01 mm. Typically a play of 0.01 to 0.05 mm can be obtained easily. The integral fabrication of parts according to the invention therefor is so accurate with respect to fitting of parts and the play between them, that an improved accuracy and repeatability of the instrument's functional performance is ensured.
Further features and advantages of the invention will become apparent from the description of the invention by way of non-limiting and non-exclusive embodiments. These embodiments are not to be construed as limiting the scope of protection. The person skilled in the art will realize that other alternatives and equivalent embodiments of the invention can be conceived and reduced to practice without departing from the scope of the present invention. Embodiments of the invention will be described with reference to the figures of the accompanying drawings, in which like or same reference symbols denote like, same or corresponding parts, and in which:
For the purpose of the present document, the terms cylindrical element and tube may be used interchangeably, i.e., like the term tube a cylindrical element also refers to a physical entity. The invention will be explained with reference to steering wires which are cut from such cylindrical elements and are operative as push and/or pull steering wires to transfer movement of the steering wires at the proximal end of the instrument to the distal end to thereby control bending of one or more flexible distal end portions. However, in some embodiments, the invention can also be implemented with steering wires made in a classic way and not resulting from cutting them out of a tube. In some embodiments, steering wire guiding element portions are also made by cutting them out of one or more tubes. They sense or measure longitudinal length differences of the instrument body walls by means of generating a length displacement at one of their ends.
Instruments in which the Invention can be Applied
a, and 3b are known from WO2009/112060. They are explained in detail because the present invention can be applied in this type of instruments.
The inner cylindrical element 2 comprises a first rigid end part 5, which is located at a distal end part 13 of the instrument, a first flexible part 6, an intermediate rigid part 7 located at an intermediate part 12 of the instrument, a second flexible part 8 and a second rigid end part 9, which is located at a proximal end part 11 of the instrument.
The outer cylindrical element 4 also comprises a first rigid end part 17, a first flexible part 18, an intermediate rigid part 19, a second flexible part 20 and a second rigid end part 21. The lengths of the parts 5, 6, 7, 8, and 9, respectively, of the cylindrical element 2 and the parts 17, 18, 19, 20, and 21, respectively, of the cylindrical element 4 are, preferably, substantially the same so that when the inner cylindrical element 2 is inserted into the outer cylindrical element 4, these different respective parts are longitudinally aligned with each other.
The intermediate cylindrical element 3 also has a first rigid end part 10 and a second rigid end part 15 which in the assembled condition are located between the corresponding rigid parts 5, 17 and 9, 21 respectively of the two other cylindrical elements 2, 4. The intermediate part 14 of the intermediate cylindrical element 3 comprises one or more separate steering wires 16 which can have different forms and shapes as will be explained below. They are made from the cylindrical element 3 themselves and have the form of a longitudinal strip. In
In the embodiment shown in
It is observed that the steering wires 16 need not have a uniform cross section across their entire length. They may have a varying width along their length, possibly such that at one or more locations adjacent steering wires 16 are only separated by a small slot resulting from the laser cutting in the cylindrical element 3. These wider portions of the steering wires, then, operate as spacers to prevent adjacent steering wires 16 from buckling in a tangential direction in a pushed state. Spacers may, alternatively, be implemented in other ways.
An embodiment with spacers is shown in
In the other two portions 61 and 63 each steering wire consists of a relatively small and flexible part 64, 65 as seen in circumferential direction, so that there is a substantial gap between each pair of adjacent flexible parts, and each flexible part 64, 65 is provided with a number of spacers 66, extending in the tangential direction and almost bridging completely the gap to the adjacent flexible part 64, 65. Because of these spacers 66 the tendency of the steering wires 16 in the flexible portions of the instrument to shift in tangential direction is suppressed and tangential direction control is improved. The exact shape of these spacers 66 is not very critical, provided they do not compromise flexibility of flexible parts 64 and 65. The spacers 66 may form an integral part with the flexible parts 64, 65 and may result from a suitable laser cutting process too.
In the embodiment shown in
The production of such an intermediate part is most conveniently done by injection moulding or plating techniques or starting from a cylindrical tube with the desired inner and outer diameters and removing parts of the wall of the cylindrical tube required e.g. by laser or water cutting to end up with the desired shape of the intermediate cylindrical element 3. However, alternatively, any 3D printing method can be used.
The removal of material can be done by means of different techniques such as laser cutting, photochemical etching, deep pressing, conventional chipping techniques such as drilling or milling, high pressure water jet cutting systems or any suitable material removing process available. Preferably, laser cutting is used as this allows for a very accurate and clean removal of material under reasonable economic conditions. The above mentioned processes are convenient ways as the cylindrical element 3 can be made so to say in one process, without requiring additional steps for connecting the different parts of the intermediate cylindrical element as required in the conventional instruments, where conventional steering cables must be connected in some way to the end parts. The same type of technology can be used for producing the inner and outer cylindrical elements 2 and 4 with their respective flexible parts 6, 8, 18 and 20. These flexible parts 6, 8, 18 and 20 can be manufactured as hinges resulting from cutting out any desired pattern from the cylindrical elements, e.g., by using any of the methods described in European patent application 08 004 373.0 filed on 10.03.2008, page 5, lines 15-26, but any other suitable process can be used to make flexible portions.
It is observed that the instruments shown in
It will be clear to the skilled person that the elongated tubular body 76 as shown in
The steering arrangement in the exemplary embodiment of the elongated tubular body 76 as shown in
Flexible zones 72, 73, 74, and 75 are, in this embodiment, implemented by providing the respective cylindrical elements with slits 72a, 73a, 74a, and 75a, respectively. Such slits 72a, 73a, 74a, and 75a may be arranged in any suitable pattern such that the flexible zones 72, 73, 74, and 75 have a desired flexibility in the longitudinal and tangential direction in accordance with a desired design.
The inner cylindrical element 101, as seen along its length from the distal end to the proximal end of the instrument, comprises a rigid ring 111, which is arranged at the distal end part 13 of the steerable instrument 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, which is arranged at the proximal end portion 11 of the steerable instrument.
The first intermediate cylindrical element 102, as seen along its length from the distal end to the proximal end of the instrument, 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. The portions 122, 123, 124, 125, 126, 127 and 128 together form a steering wire 120 that can be moved in the longitudinal direction like a wire. The longitudinal dimensions of the rigid ring 121, the first flexible portion 122, the first intermediate rigid portion 123, the second flexible portion 124, the second intermediate rigid portion 125, the third flexible portion 126, the third intermediate rigid portion 127, the fourth flexible portion 128, and the rigid end portion 129 of the first intermediate element 102, respectively, are aligned with, and preferably approximately equal to the longitudinal dimensions of the rigid ring 111, the first flexible portion 112, the first intermediate rigid portion 113, the second flexible portion 114, the second intermediate rigid portion 115, the third flexible portion 116, the third intermediate rigid portion 117, the fourth flexible portion 118, and the rigid end portion 119 of the inner cylindrical element 101, respectively, and are coinciding with these portions as well. In this description “approximately equal” means that respective same dimensions are equal within a margin of less than 10%, preferably less than 5%.
Similarly, the first intermediate cylindrical element 102 comprises one or more other steering wires of which one is shown with reference number 120a.
The second intermediate cylindrical element 103, as seen along its length from the distal end to the proximal end of the instrument, 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. The portions 133, 134, 135 and 136 together form a steering wire 130 that can be moved in the longitudinal direction like a wire. The longitudinal dimensions of the first rigid ring 131, the first flexible portion 132 together with the second rigid ring 133 and the second flexible portion 134, the first intermediate rigid portion 135, the first intermediate flexible portion 136, the second intermediate rigid portion 137, the second intermediate flexible portion 138, and the rigid end portion 139 of the second intermediate cylinder 103, respectively, are aligned with, and preferably approximately equal to the longitudinal dimensions of the rigid ring 111, the first flexible portion 112, the first intermediate rigid portion 113, the second flexible portion 114, the second intermediate rigid portion 115, the third flexible portion 116, the third intermediate rigid portion 117, the fourth flexible portion 118, and the rigid end portion 119 of the first intermediate element 102, respectively, and are coinciding with these portions as well.
Similarly, the second intermediate cylindrical element 103 comprises one or more other steering wires of which one is shown with reference number 130a.
The outer cylindrical element 104, as seen along its length from the distal end to the proximal end of the instrument, 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, respectively, are aligned with, and preferably approximately equal to the longitudinal dimension 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, and are coinciding with these portions as well. The rigid ring 141 has approximately the same length as the rigid ring 133 and is fixedly attached thereto, e.g. by spot welding or gluing. Preferably, the rigid ring 145 overlaps with the second intermediate rigid portion 137 only over a length that is required to make an adequate fixed attachment between the rigid ring 145 and the second intermediate rigid portion 137, respectively, e.g. by spot welding or gluing. The rigid rings 111, 121 and 131 are attached to each other, e.g., by spot welding or gluing. This may be done at the end edges thereof but also at a distance of these end edges.
In an embodiment, the same may apply to the rigid end portions 119, 129 and 139, which can be attached to one another as well in a comparable manner. However, the construction may be such that the diameter of the cylindrical elements at the proximal portion is larger, or smaller, with respect to the diameter at the distal portion. In such embodiment the construction at the proximal portion differs from the one shown in
The inner and outer diameters of the cylindrical elements 101, 102, 103, and 104 are chosen in such a way at a same location along the elongated tubular body 76 that the outer diameter of inner cylindrical element 101 is slightly less than the inner diameter of the first intermediate cylindrical element 102, the outer diameter of the first intermediate cylindrical element 102 is slightly less than the inner diameter of the second intermediate cylindrical element 103 and the outer diameter of the second intermediate cylindrical element 103 is slightly less than the inner diameter of the outer cylindrical element 104, in such a way that a sliding movement of the adjacent cylindrical elements with respect to each other is possible. The dimensioning should be such that a sliding fit is provided between adjacent elements. A clearance between adjacent elements may generally be in the order of 0.02 to 0.1 mm, but depends on the specific application and material used. The clearance may be smaller than a wall thickness of the steering wires to prevent an overlapping configuration thereof. Restricting the clearance to about 30% to 40% of the wall thickness of the steering wires is generally sufficient.
As can be seen in
For the sake of convenience, as shown in
In order to deflect at least a part of the distal end part 13 of the steerable instrument, it is possible to apply a bending force, in any radial direction, to zone 158. According to the examples shown in
It is to be noted that the exemplary downward bending of zone 156, only results in the upward bending of zone 154 at the distal end of the instrument as shown in
Obviously, it is possible to vary the lengths of the flexible portions shown in
In the shown embodiment, the steering wires comprise one or more sets of steering wires that form integral parts of the one or more intermediate cylindrical elements 102, 103. Preferably, the steering wires comprise remaining parts of the wall of an intermediate cylindrical element 102, 103 after the wall of the intermediate cylindrical element 102, 103 has been provided with longitudinal slits that define the remaining steering wires.
As shown, here, instrument 76 comprises a flexible zone 77 in its intermediate part between flexible zone 72 and flexible zone 74. I.e., intermediate cylindrical element 204 (which is located at the outer side in the area of flexible zone 77) is provided with a slotted structure to provide intermediate cylindrical element with a desired flexibility. The longitudinal length of the slotted structure in flexible zone 77 depends on the desired application. It may be as long as the entire part between flexible zones 72 and 74. All other cylindrical elements 206, 208, 210 inside intermediate cylindrical element 204 are also flexible in flexible zone 77. Those cylindrical elements that have steering wires in the flexible zone 77 are flexible by way of definition. Others are provided with suitable hinges, preferably made by suitable slotted structures.
Some locations to be operated in a body need specifically designed instruments. E.g., by making the intermediate part 12 of the instrument completely flexible, the instrument can also be used in areas in the body which are only accessible via curved natural access guides/channels, like the colon, the stomach via the oesophagus or the heart via curved blood vessels.
The instrument can e.g. be designed to be used as a colonoscope.
In operation, usually, several invasive instruments are inserted through the colonoscope 42 to provide one or more tools for some function at its distal end 44. In colonoscopy, such a tool typically includes a camera lens and a lighting element. To assist the surgeon in steering the camera view to the desired location and view in colon 30, typically, the distal end is deflectable from a longitudinal axis in all angular directions. This also holds for the inserted instruments with tools 2. That can be implemented by providing such an instruments with one or more deflectable zones, like the deflectable zones 16, 17 of the instrument shown in
In operation, usually, several invasive instruments are inserted through the gastroscope 56 to provide one or more tools for some function at its distal end 59. In gastroscopy, such a tool typically includes a camera lens and a lighting element. To assist the surgeon in steering the camera view to the desired location and direction in stomach 50, typically, the distal end 59 of the gastrocope 56 is deflectable from a longitudinal axis in all angular directions. This also holds for the inserted instruments with tools 2. That can be implemented by providing such an instrument with one or more deflectable zones, like the deflectable zones 16, 17 of the instrument shown in
Instruments according to the invention can be used in such colonoscopes and gastroscopes but also in other applications like instruments designed for entering the lung bronchi. Requirements to such an instrument may be that they show a high rotational stiffness, high longitudinal stiffness, bending flexibility along its entire length and accurate and repeatable deflectability of a steerable tip even in cases of long instruments, e.g., longer than 1 m, and with a relatively small diameter that fits to the working channels within or attached to colonoscopes and gastroscopes.
In order to better understand the issues dealt with in the present document, first a detailed description is provided of a prior art flexible steerable instrument with Bowden cables with reference to
A Bowden cable as known from the prior art can be defined as a type of flexible cable used to transmit mechanical force or energy by the movement of an inner cable relative to a hollow outer cable housing. The housing is generally of composite construction, consisting of an inner lining, a longitudinally incompressible layer such as a helical winding or a sheath of steel wire, and a protective outer covering. The cable housing is often called a coil pipe. Here, the term steering wire guiding will be used for the outer cable housing.
More in detail
Steering wires 1309(1), 1309(2) run from the steering section 1307 to the tip section 1301 in order to allow bending the tip section 1301 relative to body section 1303. Inside body section 1303 and length compensation section 1305, steering wires 1309(1), and 1309(2), respectively, are arranged inside steering wire guidings 1311(1) and 1311(2), respectively. Steering wire guidings 1311(1) and 1311(2), respectively, are held at a fixed position 1317(1) and 1317(2), respectively, at the transition between tip section 1301 and body section 1303. Similarly, steering wire guidings 1311(1) and 1311(2), respectively, are held at a fixed position 1319(1) and 1319(2), respectively, at the transition between length compensation section 1305 and steering section 1307.
Due to the bending, L3 is shorter than the initial steering wire guiding length L5 and L4 is longer than the initial steering wire guiding length L5. If one wants that L1 and L2 after the bending are equal to L1 and L2 before the bending, in other words, if one does not want that the tip or the steering device in steering section 1307 deflects due to bending of the body, the length difference between L5 and L3 or L4 has to be absorbed by the length compensation section 1305 as is shown in the drawing. In this drawing, the length compensation section 1305 absorbs the length differences by increasing the curve height of steering wire guiding 1311(1) with the associated portion of steering wire 1309(1) inside (which can absorb a longer length of steering wire guiding 1311(1) with steering wire 1309(1) outside body section 1303) and decreasing the curve height of steering wire guiding 1311(2) with the associated portion of steering wire 1309(2) inside (which can absorb a shorter length of steering wire guiding 1311(2) with steering wire 1309(2) outside body section 1303). In this way, tip defection is fully isolated from body deflection.
c are embodiments of the invention.
The instrument as shown is made of five tubes coaxially arranged about a central axis 1622. However, other numbers can be applied as well. An inner tube 1601 is arranged inside the instrument, which is flexible at least inside the body section 1615 but stiff in its longitudinal direction. To that end the inner tube 1601 may be provided with suitable hinges 1609 in the body section 1615, made by providing the inner tube 1601 with a suitable pattern of slots. The portions of inner tube 1601 at the transition between tip section 1613 and body section 1615 is indicated with reference sign 1611, and inside length compensation section 1617 with reference sign 1607.
A first intermediate tube 1619 surrounds inner tube 1601. First intermediate tube 1619 has a steering section portion 1619(1) which may be entirely ring shaped, a plurality of inside steering wire guiding portions 1619(2,i), i.e. one for each steering wire 16(i), in length compensation section 1617, a body section portion 1619(3) which may be ring shaped, and a tip section portion 1619(4) which may be ring shaped and provided with one or more suitable hinges. First intermediate tube 1619 and inner tube 1601 are, preferably, attached to one another at the transition between tip section 1613 and body section 1615 and at the proximal side between the length compensation section 1617 and the steering section 1618, e.g. by laser welding, gluing, etc. Body section portion 1619(3) is flexible at least in the flexible portions of body section 1615.
A second intermediate tube 1620 (cf. e.g.
A third intermediate tube 1621 surrounds second intermediate tube 1620. Third intermediate tube 1621 has a steering section portion 1621 (1) which may be entirely ring shaped, a plurality of outside steering wire guiding portions 1621(2,i), i.e. one for each steering wire 16(i), a length compensation section 1617, a body section portion 1621(3) which may be ring shaped, and a tip section portion 1621(4) which may be ring shaped and provided with one or more suitable hinges. Body section portion 1621(3) is flexible at least in the flexible portions of body section 1615.
At the distal end of the instrument, i.e., distally beyond the flexing portion of tip section 1613, all steering wires 16(i) are attached to at least one of first and third intermediate tubes 1619 and 1621 to allow for pulling and pushing forces to be transferred to the tip section 1613.
An outer tube 1602 surrounds third intermediate tube 1621. Outer tube 1602, in the shown example, has—as seen from the proximal end to the distal end—a steering section portion 1604 which may be entirely ring shaped, one or more open portions in length compensation section 1617 in order to allow the length compensation portions of tubes 1619, 1620 and 1621 to increase their extension away from central axis 1622 if desired, a ring shaped portion 1603, a flexible portion 1605 and a ring shaped portion 1606. Ring shaped portion 1606 may be attached to third intermediate tube 1621 at the transition between tip section 1613 and body section 1615.
this figure, one now also sees an outside steering wire guiding portion 1621(2,3) located on top of a steering wire 16(3) (not visible in this figure). The steering wire guiding portions 1619(2,i), 1621(2,i) are bent radially outward, with the steering element 16(i) in between. The steering element 16(i) is now radially guided by the steering wire guiding portions 1619(2,i), 1621(2,i). Note that
The steering wires cross section may have a substantially rectangular shape such that they bend easily in the radial direction, but they are difficult to be bent in the tangential direction. In that case, it is not necessary to also guide the steering wires 16(i) in tangential direction in the length compensation section 1617. I.e., they will stay between the inner and outer steering wire guiding portions 1619(2,i) and 1621(2,i) inside the length compensation section 1617 whilst pulled or pushed.
In case one uses steering elements 16(i) that are also flexible in tangential direction, it might be necessary to also guide the steering wires 16(i) in the tangential direction of the instrument. This can be accomplished as is shown in
Fracture elements 1629(j) should be designed in the following way. Before being fractured, each fracture element 1629(j) is attached to opposite portions of island 1627(j) and steering wire 16(i). These opposite portions of island 1627(j) and steering wire 16(i) have a geometrical shape such that the stresses in the fracture element 1629(j) are higher than in the surrounding material and/or structure. Therefore, if a deflection or a high enough force is applied on a structure with a fracture element 1629(j) the stress in the fracture element 1629(j) rises above the yield stress of the tube material, causing permanent deflection of fracture element 1629(j). Applying even more deflection or a higher force results in the stress reaching the ultimate tensile stress causing a fracture of fracture element 1629(j). An other mechanism to break the fracture element is achieved by applying low or high cycle fatigue to fracture element 1629(j). The stress in fracture element 1629(j) is raised above the fatigue limit, causing a fatigue fracture. In all cases the stresses in the surrounding structure/material, i.e., island 1627(j) and steering wire 16(i), stays at least below the yield stress of the tube material.
The examples of
In this way, the embodiments of
The result is a longitudinally more flexible length compensation section 1617 that requires less forces to compress or elongate. This on its turn reflects in an easier bendable body section 1615 of the instrument. Another obtainable result is that when the curve shape in length compensation section 1617 is bent outward or inward, one can balance the longitudinal flexibility of the inner and outer steering wire guiding portions 1619(2,i), 1621(2,i) such, that the average length of the inner and outer steering wire guiding portions 1619(2,i), 1621(2,i) stays exactly equal to the length of the enclosed steering wire 16(i). The bending flexibility should be designed such that the longitudinal flexibility of the length compensation section 1617 still can withstand the tip steering forces without significant elongation or shortening.
In this embodiment, a square frame element 1645 is provided which has a first bar 1645(1) and second bar 1645(2) extending in a first direction and a third bar 1645(3) and fourth bar 1645(4) extending in a second direction perpendicular to the first direction. The right hand side of
It can be shown that the distance between two opposite sets A(1)/A(3), A(2)/A(4) changes slightly when body section 1615 bends. This slight distance change can be compensated for by using bars 1645(1), 1645(2), 1645(3), 1645(4) that are resilient in the radial direction of instrument 1600.
An interesting application is holding the square frame element 1645 fixed in place, e.g. the situation of
Another advantage of connecting the apexes of the curved length compensation elements is that it can improve the response of the length compensation elements. When one bends body section 1615, one side of length compensation section 1617 is activated by a pull force in the guiding elements, whereas the opposing side of length compensation section 1617 is activated by a push force in the opposing guide element. If there is difference in the magnitude in the forces, or a difference in movement of Bowden cable elements 1619(2,i), 1621(2,i) due to their length, plays, buckling effects, etc. it is better to directly couple the deformation of Bowden cable elements 1619(2,i), 1621(2,i) at one side of length compensation section 1617 to Bowden cable elements 1619(2,i), 1621(2,i) at the opposing side of length compensation section 1617. Of course many other mechanisms to couple or freeze the shape or the length of the length compensation section can be envisioned.
b describe an instrument according to the invention in which a Bowden cable guide is built from portions of a separate first intermediate tube 1619 and a separate second intermediate tube 1621 and in which the steering wires 16(i) are made in a separate in between tube 1620. If one adds supportive inner tube 1601 and supportive outer tube 1602 that provides the structures (hinges) for the bendable sections, however, then one needs 5 tubes to build this instrument. A more efficient way is to make the steering wires 16(i) and the guidings therefore in a single tube. Embodiments of such an implementation are now explained.
In this embodiment inner, steering wire 16(1) has the following portions as viewed from the proximal end to the distal end: a flexible steering wire portion 16(1,2) in steering section 1618, a steering wire length compensation portion 16(1,3) in length compensation section 1617, a steering wire attachment portion 16(1,4) in the transition between length compensation section 1617 and body section 1615, and steering wire body section portion 16(1,5). Steering wire guiding portion 1619(2,1) and steering wire body section portion 16(1,5) are both made in intermediate tube 1619 whereas all other mentioned portions 16(1,2), 16(1,3) and 16(1,4) are made in tube 1620.
Steering wire attachment portion 16(1,4) is provided with an opening 1648 in which a sliding element 1647 is located. This sliding element 1647 is attached to first intermediate tube 1619, e.g. by laser welding, gluing, etc such that steering wire attachment portion 16(1,4) can slide along sliding element 1647 in the longitudinal direction. Moreover, steering wire attachment portion 16(1,4) is attached to steering wire body section portion 16(1,5). This attachment can be made with any suitable attachment method, preferably laser welding. In this way, any push or pull action exerted on flexible steering wire portion 16(1,2) is directly transferred to the same movement of steering wire body section portion 16(1,5) (and further to the tip section 1613).
The same construction holds for all steering wires 16(i).
After the product of
One will understand that no extra inner tube 1601 or outer tube 1602 is needed anymore, though one of them or both may be applied as well.
Contrary, control elements in the length compensation section at the same side as the outside of the bend in the instrument shaft will obtain a longer path length and will be forced towards the central axis. Steering elements 16(i) located at this outside of the bend in the flexible body section will obtain more longitudinal space inside the flexible body section but obtain less longitudinal space due to these control elements in the length compensation section.
As a consequence, steering element length changes inside flexible body section 1615 due to bending are compensated by control elements inside the length compensation section 1617 and undesired steering of the articulating tip section 1613 is avoided.
This embodiment shows Bowden cable structures for four steering wires 16(i). However, this embodiment is not limited to such a number. The number may be one or more. In length compensation section 1617 four strip like, outside steering wire guiding portions 1621(2,i) are provided which are separated by slots. Each one of the outside steering wire guiding portions 1621(2,i) spirals about the central axis of the instrument. The amount of tangential spiraling from their proximal ends to their distal ends may be 360 degrees. However, the required amount of tangential spiraling depends on the specific application and may, thus, be more or less than 360 degrees. An adequate amount may be in a range of 10-1440 degrees, for instance in a range of 45-1080 degrees.
At their distal end, each one of the four outside steering wire guiding portions 1621(2,i) is attached to an outside steering wire guiding portion end part 1621(2,i)E.
At the distal side of outside steering wire guiding portion end part 1621(2,i)E,
At the transition between steering section 1618 and length compensation section 1617, each spacer 1620(1,i) is attached to two longitudinal guiding element length compensation portions 1620a(2,i), 1620b(2,i). Inside length compensation section 1617, steering wire portion 16(1,3) is arranged between longitudinal guiding element length compensation portions 1620a(2,4) and 1620b(2,1), steering wire portion 16(4,3) between longitudinal guiding element length compensation portions 1620a(2,2) and 1620b(2,4), steering wire portion 16(2,3) between longitudinal guiding element length compensation portions 1620a(2,3) and 1620b(2,2), and steering wire portion 16(3,3) between longitudinal guiding element length compensation portions 1620a(2,1) and 1620b(2,3).
Sets of longitudinal guiding element length compensation portions 1620a(2,4)/1620b(2,1), 1620a(2,2)/1620b(2,4), 1620a(2,3)/1620b(2,2), and 1620a(2,1)/1620b(2,3), respectively, are separated from steering wire portion 16(1,3), 16(4,3), 16(2,3), and 16(3,3), respectively, by small slots such that they guide steering wire portion 16(1,3), 16(4,3), 16(2,3), and 16(3,3), respectively in the longitudinal direction and prevent independent tangential movement of steering wire 16(1,3), 16(4,3), 16(2,3), and 16(3,3), respectively in length compensation section 1617.
Towards the distal end, each one two longitudinal guiding element length compensation portions 1620a(2,i), and 1620b(2,i), respectively, is attached to an end portion 1620a(2,i)E, and 1620b(2,i)E, respectively. The two end portions 1620a(2,i)E and 1620b(2,i)E are separated by a slot such that they can move in the longitudinal direction independently. In an embodiment, the slot is configured such that the two end portions 1620a(2,i)E and 1620b(2,i)E prevent mutual tangential movement.
All end portions 1620a(2,i)E, 1620b(2,i)E, in a rest situation, are arranged such that there is a free space towards the distal direction allowing them to be movable in the distal direction. In the shown embodiment, this free space ends at the transition between length compensation section 1617 and flexible body section 1615. Portions of the steering wires 16(i) inside this free space are indicated with reference numbers 16(i,4), whereas the portions of steering wires 16(i) in flexible body section 1615 are indicated with reference numbers 16(i,5). In the shown embodiment, the steering wire portions 16(i,5) are wider at the transition between length compensation section 1617 and flexible body section 1615 than inside that free space, however, that is not required.
In the assembled state of the present embodiment, third intermediate tube 1621 is present outside second intermediate tube 1620, each one of the outside steering wire guiding portions 1621(2,i) is aligned with one steering wire portion 16(i,3) such that it covers that steering wire portion 16(i,3) along its entire length and prevents any radial movement of that steering wire portion 16(i,3) independently from radial movement of outside steering wire guiding portion 1621(2,i).
In an embodiment, to further prevent independent tangential movement of steering wire portions 16(1,3), 16(4,3), 16(2,3), and 16(3,3), respectively, each set of end portions 1620a(2,4)E/1620b(2,1)E, 1620a(2,2)E/1620b(2,4)E, 1620a(2,3)E/1620b(2,2)E, and 1620a(2,1)E/1620b(2,3)E, respectively, of each set of longitudinal guiding element length compensation portions 1620a(2,4)/1620b(2,1), 1620a(2,2)/1620b(2,4), 1620a(2,3)/1620b(2,2), and 1620a(2,1)/1620b(2,3), respectively, is attached to one end portion 1621(2,1)E, 1621(2,3)E, 1621(2,2)E, and 1621(2,4)E, respectively, at attachment locations 1655a, 1655b (cf.
The pattern of slots as provided in first intermediate tube 1619, and as shown in
In this embodiment, cf.
In length compensation section 1617 four strip like inside steering wire guiding portions 1619(2,i) are provided which are separated by slots. Each one of the inside steering wire guiding portions 1619(2,i) spirals about the central axis of the instrument, in the same way as do outside steering wire guiding portions 1621(2,i) and steering wire portions 16(2,i).
At their distal end, each one of the four inside steering wire guiding portions 1619(2,i) is attached to an inside steering wire guiding portion end part 1619(2,i)E.
Each set of end portions 1620a(2,4)E/1620b(2,1)E, 1620a(2,2)E/1620b(2,4)E, 1620a(2,3)E/1620b(2,2)E, and 1620a(2,1)E/1620b(2,3)E, respectively, of each set of longitudinal guiding element length compensation portions 1620a(2,4)/1620b(2,1), 1620a(2,2)/1620b(2,4), 1620a(2,3)/1620b(2,2), and 1620a(2,1)/1620b(2,3), respectively, in second intermediate tube 1620 (cf.
Each one of these inside steering wire guiding portion end parts 1619(2,i)E is, in a rest condition (i.e., no bending of the flexible body section 1613), arranged such that it is at a distance from flexible body section 1615. Thus, each one of them can move in the longitudinal direction to a certain designed extent, both in the proximal direction and in the distal direction, independently from all other inside steering wire guiding portion end parts 1619(2,i)E.
Turning now to
Referring also to
As shown in
The width of outside steering wire guiding portion 1621(2,1) 1621(2,4), 1621(2,2), and 1621(2,3), respectively, may be equal to the width of steering wire portion 16(1,3) plus the width of the set of longitudinal guiding element t length compensation portions 1620a(2,4)/1620b(2,1), the width of steering wire portion 16(4,3) plus the width of the set of longitudinal guiding element length compensation portions 1620a(2,2)/1620b(2,4), the width of steering wire portion 16(2,3) plus the width of the set of longitudinal guiding element length compensation portions 1620a(2,3)/1620b(2,2), and the width of steering wire portion 16(3,3) plus the width of the set of longitudinal guiding element length compensation portions 1620a(2,1)/1620b(2,3), respectively.
Moreover, the width of inner steering wire guiding portions 1619(2,1) 1619(2,4), 1619(2,2), and 1619(2,3), respectively, may be equal to the width of outer steering wire guiding portions 1621(2,1) 1621(2,4), 1621(2,2), and 1621(2,3), respectively.
As a consequence, each steering wire portion 16(i,3) is located inside a channel in length compensation section 1617. I.e., steering wire portion 16(1,3) is located in a channel formed by inner steering wire guiding portions 1619(2,1), longitudinal guiding element length compensation portions 1620a(2,4)/1620b(2,1), and outside steering wire guiding portion 1621(2,1). Steering wire portion 16(4,3) is located in a channel formed by inner steering wire guiding portions 1619(2,4), longitudinal guiding element length compensation portions 1620a(2,2)/1620b(2,4), and outside steering wire guiding portion 1621(2,4). Steering wire portion 16(2,3) is located in a channel formed by inner steering wire guiding portions 1619(2,2), longitudinal guiding element length compensation portions 1620a(2,3)/1620b(2,2), and outside steering wire guiding portion 1621(2,2). Steering wire portion 16(3,3) is located in a channel formed by inner steering wire guiding portions 1619(2,3), longitudinal guiding element length compensation portions 1620a(2,1)/1620b(2,3), and outside steering wire guiding portion 1621(2,3).
Length compensation section 1617 of the embodiment of
Assume flexible body section 1615 is bent such that the proximal end of extra intermediate tube shiftable portion 1608(1) is pushed towards the proximal end. Then, the proximal end of extra intermediate tube shiftable portion 1608(1), inner steering wire guiding portion end part 1619(2,1)E, the set of end portions 1620a(2,4) E/1620b(2,1)E of longitudinal guiding element length compensation portions 1620a(2,4)/1620b(2,1), and outer guiding steering wire guiding portion end part 1621(2,1)E slide towards the proximal end because they are all attached. This causes the spiraling part of inner steering wire guiding portion 1619(2,1), longitudinal guiding element length compensation portions 1620a(2,4)/1620b(2,1), and outside steering wire guiding portion 1621(2,1) in the length compensation section 1617 to be moved away from the central axis. This causes more path length to be available for steering wire 16(1) in length compensation section 1617 which is necessary to compensate for steering wire portion 16(1,5) longitudinally moving into length compensation section 1617 to a certain extent because of the bending of the flexible body section 1615.
Because of the bending of the flexible body portion 1615 oppositely located proximal end of extra intermediate tube shiftable portion 1608(2) is pulled towards the distal end. Then, the proximal end of extra intermediate tube shiftable portions 1608(2), inner steering wire guiding portion end part 1619(2,2)E, the set of end portions 1620a(2,3)E/1620b(2,2)E of longitudinal guiding element length compensation portions 1620a(2,3)/1620b(2,2), and outer guiding steering wire guiding portion end part 1621(2,2)E slide towards the distal end because they are all attached. This causes the spiraling part of inner steering wire guiding portion 1619(2,2), longitudinal guiding element length compensation portions 1620a(2,3)/1620b(2,2), and outside steering wire guiding portion 1621(2,2) in the length compensation section 1617 to be moved towards the central axis. This causes less path length to be available for steering wire 16(2) in length compensation section 1617 which is necessary to compensate for steering wire portion 16(2,4) longitudinally moving into flexible body section 1615 to a certain extent because of the bending of the flexible body section 1615.
The bending inside flexible body section 1615 may be such that steering wire portions 16(3,4)/16(3,3) and 16(4,4)/16(4,3) do not move at all and need no length compensation. However, depending on the direction of that bending they may also move which will be compensated in a similar way in length compensation section 1617.
Thus, all movements of the steering wire portions 16(i,5) inside flexible body section 1615 due to bending of that section is compensated by the Bowden cable structure inside length compensation section 1617, and the tip section 1613 is not bent inadvertently.
Of course one can envision more embodiments in which body structures, steering wires and Bowden cable elements are combined in tubes with the intention to reduce the number of required tubes and to make assembly of such an instrument as easy as possible.
In the implementation example of
In the body section 1615, steering wire portion 16(1,5) is arranged between longitudinal guiding element body portions 1620a(3,4) and 1620b(3,1), steering wire portion 16(4,5) between longitudinal guiding element body portions 1620a(3,2) and 1620b(3,4), steering wire portion 16(2,5) between longitudinal guiding element body portions 1620a(3,3) and 1620b(3,2), and steering wire portion 16(3,5) between longitudinal guiding element body portions 1620a(3,1) and 1620b(3,3). These latter longitudinal guiding element body portions run to the transition between the body section 1615 and tip section 1613 and are attached there to the inner tube 1601 or outer tube 1602 or both by, e.g., laser welding, gluing, etc. to prevent longitudinal motion at that location. The embodiment of
Each one of the steering wires 16(i) is split into two portions, i.e., a first portion and a second portion. The first portion is provided with a protrusion 16(i,9) extending in the tangential direction at a predetermined angle<90 degrees but >0 degrees. For instance, 30 degrees<angle<80 degrees. The second portion, which is attached to the distal end of the tip section 1613, has a recess 16(i,8), e.g., located between two extensions 16(i,6) and 16(i,7). The recess 16(i,8) is shaped to receive protrusion 16(i,9) in a slidable way. To that end, in an embodiment, recess 16(i,8) has an identical form as protrusion 16(i,9), i.e., is also extending in the tangential direction at the same angle.
In between the steering wires 16(i), steering wire guiding elements are provided. These steering wire guiding elements are attached to the body of the instrument. In the shown embodiment, they are located 90 degrees rotated from the steering wires 16(i) in the tangential direction. These steering wire guiding elements are grouped in sets of two steering wire guiding elements. Each set has a first steering wire guiding element 1620(3,1), 1620(3,3) and a second steering wire guiding element 1620(3,2) and 1620(3,4). Each first steering wire guiding element 1620(3,1), 1620(3,3) has a recess 1620(3,1,1), 1620(3,3,1). Each second steering wire guiding element 1620(3,2), 1620(3,4) has a protrusion 1620(3,2,1), 1620(3,4,1) which is received in the recess 1620(3,1,1), 1620(3,3,1) of first steering wire guiding element 1620(3,1), 1620(3,3). Both protrusion 1620(3,2,1), 1620(3,4,1) and recess 1620(3,1,1), 1620(3,3,1) are extending in the tangential direction at a predetermined angle<90 degrees but >0 degrees. For instance, 30 degrees<angle<80 degrees. These angles may be the same as applied in the steering wire protrusions 16(i,9) and steering wire recesses 16(i,8).
First steering wire guiding elements 1620(3,1) and 1620(3,3) are connected to the body of the instrument in the area of the proximal end of the steerable tip section. Second steering wire guiding elements 1620(3,2) and 1620(3,4) are connected to suitable portions of the body of the instrument too.
When the body section 1615 of the instrument of
Yet, if one moves the steering wires in a longitudinal direction such as to deflect the tip section 1613 in a desired way this is not affected by the shown construction. Longitudinal movement of the first portion of steering wire 16(i) is transferred to a same longitudinal movement of the second portion of steering wire 16(i).
a/28b show only two possible embodiments in which the length compensation section 1617 is cut in a single tube 1620. One can envision that more shapes are possible and that also length compensation sections can be build making use of more than one tube.
Each longitudinal guiding element length compensation portion 1620(2,2) is a portion of a longitudinal guiding element 1620(2,1), 1620(2,2), 1620(2,3). At the transition between length compensation section 1617 and steering section 1618, each steering wire steering section portion 16(i,2) is tangentially located between two adjacent proximal longitudinal guiding element portions 1620(2,1) which are attached to inner tube 1619 or outer tube 1621 or both by, e.g., laser welding, gluing, etc. In the body section 1615, each steering wire body section portion 16(i,4) is tangentially located between two adjacent longitudinal guiding element body portions 1620(2,3) which run to the transition between the body section 1615 and tip section 1613 and are attached there to the inner tube 1619 or outer tube 1621 or both by, e.g., laser welding, gluing, etc. to prevent longitudinal motion at that location. Again, separation slots may be very small, i.e., as small as resulting from the smallest possible laser beam used to make the slot.
Alternatively, a set of separate processors is applied each one connected to one set of one sensor 1663(i) and one actuator 1665(i) to perform the above mentioned function. Each one of the set of separate processors can be either located close to or inside a respective sensor 1663(i) or close to or inside a respective actuator 1665(i).
Moreover, in this example, each actuator 1665(i) is configured to move its steering wire 1309(i)/steering wire 16(i) as controlled by a suitable actuator signal generated by processor 1670 to control deflection of the tip section 1301/1613. Processor 1670 can generate the compensation signal and actuation signal simultaneously. This can be useful for active steering of the tip section 1301/1613 while advancing the instrument through a curved channel, e.g., inside a human body.
Each applied processor is equipped with a central processing unit, CPU, connected to suitable memory units (RAM, ROM, EPROM, etc.) and to suitable input/output units. The memory units are storing suitable computer programs which, once loaded by the CPU, provide the CPU with the capacity to perform the required functions. Input units are configured to receive input signals, e.g. from sensors 1663(i) and send them to the CPU for further processing. Output units are configured to receive output signals from the CPU and transmit them to external devices like actuation motors 1665(i) and brakes 1671 (i).
As explained in
In more detail,
Here, body length sensing element 3201 extends into the space between first and second walls 3202 and 3204 through a suitable opening in first wall 3202. Body length sensing element 3201 is provided with a protrusion 3206 extending in a slot 3212 inside first slider 3218. Here, slot 3212 is straight and extending at an angle 0<α1<90 degrees to the longitudinal direction.
First steering wire portion 16(i,1) also extends into the space between first and second walls 3202 and 3204 through a suitable opening in first wall 3202. First steering wire portion 16(i,1) is provided with a protrusion 3208 extending in a slot 3214 inside second slider 3219. Here, slot 3214 is straight and extending at an angle 0<α2<90 degrees to the transverse direction. Second steering wire portion 16(i,2) also extends into the space between first and
second walls 3202 and 3204 through a suitable opening in second wall 3204 such that first and second steering wire portions 16(i,1), 16(i,2) extend in opposite directions from length compensation section 3200. Second steering wire portion 16(i,2) is provided with a protrusion 3210 extending in a slot 3216 inside second slider 3219. Here, slot 3216 is straight and extending in the transverse direction.
All protrusions 3206, 3208, 3210 can be implemented as a fixed protrusion either round or shaped in the geometry of the corresponding slot, or this can be for example a pin and wheel construction to reduce sliding friction, as shown in
In
If second steering wire portion 16(i,2) is held stationary in place, for example by a (manual or robotic) steering input unit attached to second steering wire portion 16(i,2), second slider 3219 will not move in the longitudinal direction when it moves upward in the transverse direction, because slot 3216 in which steering wire 4b is connected, is extending in the transverse direction. Due to the other angled slot 3214 in second slider 3219, the end of first steering wire portion 16(i,1), attached to protrusion 3208 inside angled slot 3214, is displaced in the longitudinal direction over a distance Lr when second slider 3219 moves upward in the transverse direction together with first slider 3218. If the tilt angle 90-α2 of slot 3214 in second slider 3219 is the same as the tilt angle α1 of slot 3212 in first slider 3218, then the displacement Lr of first steering wire portion 16(i,1) is caused to be exactly the same as the displacement La of the body length sensing element 3201. When one now wants to steer the tip (e.g. located at the left hand side of the drawing of
It is observed that angle α1 may deviate from angle α2 such that displacements La and Lr may be different.
Internal frictions and activation forces in the length compensation section 3200 are strongly dependent on the tilt angles α1, α2 of the respective slots 3212, 3214. For example, if slot 3212 in first slider 3218 is close to the longitudinal direction one can understand that the activation force needed to move slider 3218 up with the body length sensing element 3201, is very low and the friction between protrusion 3206 and slot 3212 is also very low. If slot 3212 in first slider 3218 is close to the transverse direction, one can understand that one needs a very high activation force to move first slider 3218 up (or down) and that also the friction between protrusion 3206 and slot 3212 is very high. At the same time angle α2 should be minimized to allow protrusion 3208 to slide in slot 3214 with minimum friction once first and second sliders 3218, 3219 move up or down, but to prevent protrusion 3208 to slide easily in slot 3214 when one pulls or pushes second steering wire portion 16(i,2). So one can conclude that one must minimize tilt angles α1, and α2 as much as possible to keep frictions and activation forces at an acceptable level. In the above example, if one wants to minimize the tilt angles α1, α2 of both slots 3212, 3214 at given displacements La, Lr and H1, H2, these tilt angles must be around 45 degrees. A suitable design range for both of them would be between 35-55 degrees, preferably between 40-50 degrees.
The mechanism of
A difference between the embodiment of
In the above schematic solution of
Protrusion 3210 attached to second steering wire portion 16(i,2) extends in slot 3216 inside fourth slider 3219b. Here, slot 3216 is straight and extends at angle 0<α3<90 degrees to the transverse direction. Angles α2 and α3 are directed in opposite directions relative to the transverse direction.
Steering wire 16(i) is provided with a third steering portion 16(i,3) arranged between first steering portion 16(i, 1) and second steering wire portion 16(i,2) in the longitudinal direction. A first end of third wire portion 16(i,3) is attached to a protrusion 3220 extending in a slot 3222 inside third slider 3219a at an angle 0<α4<90 degrees. Angles α2 and α4 are directed in opposite directions relative to the transverse direction. A second end of third wire portion 16(i,3), opposite to the first end, is attached to a protrusion 3224 extending in a slot 3226 inside fourth slider 3219b at an angle 0<α5<90 degrees. Angles α3 and α5 are directed in opposite directions relative to the transverse direction.
The longitudinal displacement of first steering wire portion 16(i,1) and protrusion 3208 is indicated with Lr1. The longitudinal displacement of second steering wire portion 16(i,2) and protrusion 3210 is indicated with Lr2. The longitudinal displacement of third steering wire portion 16(i,3) and protrusion 3220 relative to third slider 3219a is indicated with Lr4 The longitudinal displacement of third steering wire portion 16(i,3) and protrusion 3224 relative to fourth slider 3219b is indicated with Lr3.
In the embodiment of
One can envision that one can have more than one group of body length sensing elements. In
Second length compensation section comprises a third wall 3230 extending in in parallel to the first and second walls 3202, 3204, and a third slider 3228 which can slide up and down between walls 3204 and 3230 in the transverse direction as indicated with an arrow dV2. Third slider 3228 is provided with an opening 3237 accommodating a fourth slider 3232 such that fourth slider 3232 can slide back and forth in opening 3237 in a direction parallel to the longitudinal direction.
Here, body length sensing element 3203(i) of the second group extends into the space between second and third walls 3204, 3230 through a suitable opening in second wall 3204. Body length sensing element 3203(i) is provided with a protrusion 3227 extending in a slot 3229 inside third slider 3228. Here, slot 3229 is straight and extending at an angle 0<α6<90 degrees to the longitudinal direction.
Third steering wire portion 16(i,3) also extends into the space between second and third walls 3204 and 3230 through a suitable opening in second wall 3204. Third steering wire portion 16(i,3) is provided with a protrusion 3236 extending in a slot 3234 inside fourth slider 3232. Here, slot 3216 is straight and extending at an angle 0<α8 <90 degrees to the transverse direction.
Second steering wire portion 16(i,2) also extends into the space between second and third walls 3204, 3230 through a suitable opening in third wall 3230 such that second and third steering wire portions 16(i,2), 16(i,3) extend in opposite directions from length compensation section 3200. Second steering wire portion 16(i,2) is provided with a protrusion 3240 extending in a slot 3238 inside fourth slider 3232. Here, slot 3238 is straight and extending at an angle 0<α7<90 degrees to the transverse direction.
The sensing elements 3203(i), 3203(i+1) of the second group sense the length change La2 of body section 1303b. This change has to be compensated fully so Lr2+Lr3=La2. The sensing elements 3201(i), 3201(i+1) of the first group sense the length change of body section 1303b plus the length change of body section 1303a. The length change of body section 1303b was already compensated by the mechanisms attached to the sensing elements 3203(i), 3203(i+1) of the second group and therefor does not have to be compensated anymore by the mechanism attached to sensing elements 3201(i), 3201(i+1) of the first group. The only compensation this mechanism has to generate is the compensation of body section 1303a plus a certain amount of over-compensation that forces the tip section 1301 in a bent configuration in the same direction as the bend in body section 1303a. So Lr1+Lr4=La1−La2+over-compensation.
This embodiment might be useful in case of advancement of the instrument through a curved channel as depicted in
One can also envision that within the scope of the invention, more than one group of steering wires can be used and that the input signal of one set of body length sensing wires can be used to compensate the length of two sets of steering wires with which two steerable tip sections can be steered independently from each other. Cf.
First portion 16(i+1,1) of the second steering wire also extends into the space between first and second walls 3202 and 3204 through a suitable opening in first wall 3202. First portion 16(i+1,1) is provided with a protrusion 3248 extending in a slot 3246 inside a third slider 3244. Here, slot 32146 is straight and extending at an angle 0<α9<90 degrees to the transverse direction. Third slider 3244 is arranged inside first slider 3218 such as to be movable inside first slider 3218 in the longitudinal direction independently from first slider 3218 but movable in the transverse direction only together with first slider 3218.
Second portion 16(i+1,2) of the second steering wire also extends into the space between first and second walls 3202 and 3204 through a suitable opening in second wall 3204 such that first and second portions 16(i+1,1), 16(i+1,2) extend in opposite directions from length compensation section 3200. Second portion 16(i+1,2) is provided with a protrusion 3252 extending in a slot 3250 inside second slider 3219. Here, slot 3250 is straight and extending at angle α10 to the transverse direction.
The mechanism now works the same for both steering wires 16(i) and 16(i+1) and does not need any further clarification here.
Like the mechanism of
A practical problem may be that long instruments are often packed in a package with a hoop. Packaging a long instrument in a rolled up circular form results in a more compact and handier packing box shape than a very long, small and thin box. A problem with rolling up an instrument is that displacements of the body length sensing elements can be very high and if fact much higher than the displacements that are generated during normal use of an instrument. To prevent that the sensing elements break or buckle during rolling up, the compensation mechanism must be able to handle large length changes. In practice this can be a problem, because the allowable sliding capability of slider 3218 (and 3228) is limited. Another method is to absorb the length change of the body length sensing elements in another way as is depicted in
In
The same principle can, of course be applied in all other shown and explained embodiments.
In this way, excessive length change of the body length sensing elements is possible, without increasing transverse displacement H to an impractical magnitude. Trade-off is that once longitudinal displacement La is reached, further displacement of the body length sensing element does not compensate the steering wires anymore and as a result of that the tip section will not be kept straight anymore. If the packaging hoop tube has a diameter that is large enough to accommodate a bent tip, this is not a problem.
In the above examples of
The mechanism as explained with reference to
If one wants to apply a mechanism as presented in the previously shown
For example, as shown in
However, one could overcome this problem when one would use a body length sense element for activation of first slider 3218 that displaces second slider 3219 with inversed slots that compensates the length of a steering wire 16(i) at a circumferential location exactly 180 degrees different from the location of body length sensing element 3201.
Another solution is to locate the body length sensing elements 3201 and the steering wires in different tube layers, as is shown in
Second tube 4204 also comprises first steering wire attachments 4212(i) attached to steering wire 16(i) and located inside openings 4216(i) for every other steering wire 16(i). Their functioning is the same as of first steering wire attachment 4212(1). Moreover, second tube 2404 comprises a sense element attachment 4220(i) attached to a respective sense element 3201 (i) and located in opening 4218(i) for every sense element 3201 (i). Their functioning is the same as of sense element attachment 4220(1).
The figure also shows first and second length compensation activation cylinders 4206(2) and 4206(4) which may be separated by a short cylinder 4206(3). Their function is the same as the one of slider 3218 in
First length compensation activation cylinder 4206(2) is provided with two slots 4234 extending at opposite angles (>0 but <90 degrees) relative to the circumferential direction. A protrusion (not visible in
Thus,
Rotation of first and second length compensation activation cylinders 4206(2) and 4206(4) is activated by protrusions 4238(i), i.e., they operate as cam followers. When a body length sensing element 3201(i) moves in a longitudinal direction, the respective cam follower forces the respective cylinder to rotate, cf. protrusions 3206 in slot 3212 in slider 3218.
Fourth tube 4208 also comprises a cylinder 4208(2) with two longitudinally extending strips 4248 which are located 180 degrees tangentially rotated relative to one another and act as linear guiding strips. Linear guiding strips 4248 are attached, e.g. welded, to length compensation cylinder 4206(2) (acting as slider 3218) such that they can rotate together with length compensation cylinder 4206(2). Between these two longitudinally extending strips 4248 fourth tube 4208 comprises two length compensation sliders 4208(3) (acting as sliders 3219) which are located 180 degrees tangentially rotated relative to one another. Each length compensation slider 4208(2) comprises two slots 4254, 4256 oriented at opposing angles to the circumferential direction (these slots are comparable to slots 3214, 3216 in the embodiment of
Fourth tube 4208 also comprises a cylinder 4208(5) with two longitudinally extending strips 4265, 4267 which are located 180 degrees tangentially rotated relative to one another and act as linear guiding strips. Linear guiding strips 4265, 4267 are attached, e.g. welded, to length compensation cylinder 4206(2) (acting as slider 3218) such that they can rotate together with length compensation cylinder 4206(4). Between these two longitudinally extending strips 4265, 4267 fourth tube 4208 comprises two length compensation sliders 4208(4) (acting as sliders 3219) which are located 180 degrees tangentially rotated relative to one another. Each length compensation slider 4208(4) comprises two slots 4258, 4260 oriented at opposing angles to the circumferential direction (these slots are comparable to slots 3214, 3216 in the embodiment of
First steering wire portion 4270(i) (steering wire portion 16(i, 1)) can only move in the longitudinal direction and the linear guidings 4278(i) prevent movement in a tangential/circumferential direction. The same applies to the second steering wire portion 4274(i) (steering wire portion 16(i,2)).
At its distal end, first steering wire portion 4270(i) is attached to third attachment slider 4242(i) at an attachment location 4272, e.g. by laser welding. At its proximal end, first steering wire portion 4270(i) is attached to protrusion 4262 in slot 4258 at an attachment location 4273. At its distal end, second steering wire portion 4274(i) is attached to protrusion 4264 in slot 4260 at an attachment location 4275, e.g. by laser welding. Therefore if length compensation slider 4206(4) rotates, forced by longitudinal displacement of a body length sensing element, and one holds the proximal steering wire 16(i) in a fixed position, linear guidings 42645, 4267 will also rotate together with length compensation sliders 4208(4) and the protrusions 4262, 4264 will force the first steering wire portion 4270(i) in a required longitudinal direction over the required distance for full length compensation of steering wire 16(i).
It will be evident to persons skilled in the art how the mechanism works for all four steering wires 16(i) of the embodiment of
In practice, there is a last tubular element provided over the assembly shown in
Obviously, the embodiment described above with reference to
In the above described steerable instrument, during manufacturing, fracture elements are applied. Examples of fracture elements and the way they can be used during the manufacturing were first explained in detail in WO2016/089202 of the present applicant.
In general, as e.g. explained here with reference to fracture elements 1629(j), such fracture elements can be designed in the following way. Fracture elements are made in the same process step as other elements are cut from a tube. Before being fractured, each fracture element is attached to opposite portions of two tube portions. In this way they keep these two opposite portions together and prevent the two portions from falling apart after the cutting process. These opposite portions have a geometrical shape such that the stresses in the fracture element will increase more than the stresses in the surrounding material and/or structure during manipulation. Therefore, if a deflection or a high enough force is applied on the two opposite portions such as to try to move them relative to one another, the stress in the fracture element rises above the yield stress of the tube material, causing permanent deflection of the fracture element. Applying even more deflection or a higher force results in the stress reaching the ultimate tensile stress of the fracture element causing a fracture of fracture element without causing a permanent deformation of the two portions because the stress as developed in the two portions remains below their yield stress.
In this way elements of the tubes that should be independently movable relative to one another in the final steerable instrument can be separated while the different tubes are inserted into one another and the elements cannot fall apart anymore. I.e., the process of fracturing is preferably done when the steerable instrument is finished and all tubes are inserted into one another, and the elements that should be attached to one another have been attached.
This is schematically shown in
Although
An other mechanism to break the fracture element 4306 may be achieved by applying low or high cycle fatigue to a fracture element. The stress in fracture element is raised above the fatigue limit, causing a fatigue fracture. Note that this fatigue limit is lower than the above mentioned ultimate tensile stress. In all cases the stresses in the surrounding structure/material of the two opposite tube elements to which fracture element 4306 is attached stays at least below the yield stress of the tube material. The process of fracturing by applying several fatigue cycles is preferably done when the steerable instrument is finished and all tubes are inserted into one another, and the elements that should be attached to one another have been attached
Whereas
Although
It is observed that a melt element can also be designed to release an attachment between two tube portions by applying several steps, i.e., a first step in which the melt element is only partly evaporated and a second step in which the remaining part of the melt element is fractured either by the above explained fracturing process or the process of applying several fatigue cycles.
The melting process is performed at any suitable moment during manufacturing of the steerable instrument, as long as the melt element can be reached by the energy beam, e.g. via a suitable opening in a surrounding tube.
The fracture elements and melt elements as explained with reference to
The material removal means can be a laser beam that melts and evaporates material or water jet cutting beam and this beam can have a width of 0.01 to 2.00 mm, more typically for this application, between 0.015 and 0.04 mm. So slots between adjacent parts of a tube may have a minimum width of between 0.01-2.00 mm, more specifically 0,015-0.04 mm.
The wall thickness of tubes depend on their application. For medical applications the wall thickness may be in a range of 0.03-2.0 mm, preferably 0.03-1.0 mm, more preferably 0.05-0.5 mm, and most preferably 0.08-0.4 mm. The diameter of tubes depend on their application. For medical applications the diameter may be in a range of 0.5-20 mm, preferably 0.5-10 mm, more preferably 0.5-6 mm. The radial play between adjacent tubes may be in range of 0.01-0.3 mm.
Longitudinal and other elements in one tube can be attached to longitudinal and other elements in adjacent tubes such that they are together operable to transfer a longitudinal motion from a steering wire at the proximal end of the instrument to a bendable portion of the instrument at the distal end of the instrument such that the bendable portion bends. This is explained in detail in WO 2017/213491 (cf. e.g.
It will be clear to a person skilled in the art that the scope of the invention is not limited to the examples discussed in the foregoing, but that several amendments and modifications thereof are possible without deviating from the scope of the invention as defined in the attached claims. While the invention has been illustrated and described in detail in the figures and the description, such illustration and description are to be considered illustrative or exemplary only, and not restrictive. The present invention is not limited to the disclosed embodiments but comprises any combination of the disclosed embodiments that can come to an advantage.
Variations to the disclosed embodiments can be understood and effected by a person skilled in the art in practicing the claimed invention, from a study of the figures, the description and the attached claims. In the description and claims, the word “comprising” does not exclude other elements, and the indefinite article “a” or “an” does not exclude a plurality. In fact it is to be construed as meaning “at least one”. The mere fact that certain features are recited in mutually different dependent claims does not indicate that a combination of these features cannot be used to advantage. Any reference signs in the claims should not be construed as limiting the scope of the invention. Features of the above described embodiments and aspects can be combined unless their combining results in evident technical conflicts.
Number | Date | Country | Kind |
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2028414 | Jun 2021 | NL | national |
2030158 | Dec 2021 | NL | national |
Filing Document | Filing Date | Country | Kind |
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PCT/NL2022/050318 | 6/8/2022 | WO |