Steerable device for use in body of mammal

Abstract

The present invention relates to a steerable device (10) comprising an elongate element (12) configured to traverse through a mammalian body in a navigational manner. The elongate element (12) has a device tip (20) configured to allow manipulation of the elongate element (12) by an external magnetic field. Further, the device tip (20) comprises a plurality of segments (26), each segment (26) comprising a segment body (36) and a segment interface (38a, 38b), and a plurality of connectors (24), each connector (24) comprising a connector body (40) and a connector interface (42a, 42b). The connector interfaces (42a, 42b) and the segment interfaces (38a, 38b) each have complementary shapes to allow rotational movement relative to each other and to form a connection to maintain the connector and the segment in a mated state, and the magnetic element (34) at least partially forms the segment body or the connector body or both.

Description

Technical Field

[0001] The present invention relates to a manipulable device for use in a mammal, which may be a needle, a guide wire, a tube, an endoscope or any other flexible device designed to be inserted into a mammal's body (particularly a lumen or cavity) for diagnostic or interventional purposes. Background Art

[0002] Many medical procedures require navigation of medical devices to specific locations within the body. Examples include deep brain stimulation, organ biopsies, targeted drug delivery, tumor resection, etc. The insertion and navigation of such devices is accomplished in a variety of ways depending on the application.

[0003] In the case of procedures within a body cavity (e.g., the abdomen or inside the bladder) or within the vasculature, the flexible device is typically manipulated by pulling on a wire or rotating a pre-bent distal tip while being pushed proximally. There is an inherent tradeoff between the device's ability to reach the target location and its ability to be advanced without bending.

[0004] Some proposed devices have magnetic tips that allow the device to be more flexible and the trajectory of the device to be more precisely controlled by a magnetic field. However, magnetic manipulation generally requires a trade-off between the volume of magnetic material present at the magnetic tip and stiffness (particularly axial stiffness). Since the torque generated by magnetic manipulation is generally lower than the torque generated by traditional pull-wire manipulation, the magnetic manipulation device must have a very flexible magnetic tip. In addition, the magnetic tip must also have a sufficient volume of magnetic material to be effectively manipulated. Often, these two goals are contradictory because rigid magnetic material will compromise the flexibility of the tip of the device. In addition, the flexibility required for the magnetic manipulation device prevents more rigid tools (such as biopsy probes) from being used in conjunction with the device, and the volume of magnetic material required is a factor that limits the reduction in the diameter of the device.

[0005] Traditionally, magnetically steered medical devices consist of one or more magnets separated by a very flexible polymer.

[0006] US3,674,014 discloses a flexible conduit tip that can be guided into a selected artery of the body by a magnetic field, the flexible conduit tip comprising a plurality of permanent magnetic tubular segments with spherical ends, the plurality of permanent magnetic tubular segments being arranged end to end. Each pair of adjacent ends is coated with a tubular connector formed of a non-magnetic material (i.e., the shape of the connector is non-complementary relative to the corresponding spherical ends), which provides a flexible, fluid-tight seal between the tubular segments. An inclined surface is formed on each spherical end to provide stability between adjacent segments and thus to provide stability to the entire conduit tip when fully bent. The diameter of such a device is limited by the fact that the diameter of the tubular segments with spherical ends and the diameter of the tubular connector are limited by their respective mechanical strengths.

[0007] There remains a need to access deeper body cavities or more distant target sites in the vascular system through sharp bends in body passages and lumens where the size of the lumen decreases with distance. There also remains a need to maneuver medical devices in an open space such as the intestine, bladder, stomach or other body cavities in a stable manner without twisting. Summary of the invention

[0008] An object of the present invention is to provide a device for use in a mammalian body that can be used in a reliable and reusable manner for diagnostic and / or interventional purposes that require navigation in an open space in a stable manner without distortion and that requires high navigation accuracy to pass through sharp bends at branch junctions in body passages and through lumens of smaller size to reach target locations, and the device is not limited by the above-mentioned devices.

[0009] According to the invention, this object is achieved by providing a device having the features of claims 1 and 15. Further advantageous embodiments of the invention are subject matter of the dependent claims.

[0010] The present invention discloses a manipulable device for use in a mammal, which is a needle, a guide wire, a pipe, an endoscope or a similar instrument, and is used for, for example, inspection and / or operation in a mammal (especially in a human body). The manipulable device can be used to inspect and / or operate the inside of an organ (such as the stomach, intestines, liver, lungs, kidneys, brain, etc.), the inside of a body cavity (such as the abdomen, spinal cord, sinuses, etc.), or the vascular system.

[0011] The steerable device includes a flexible, elongated member extending along a longitudinal axis of the device, wherein the elongated member is flexible and configured to enter soft tissue of a mammalian body through an incision or orifice or other suitable means and to navigate through the mammalian body in a navigated manner.

[0012] Furthermore, the elongated element comprises a flexible device tip, which is configured to allow manipulation of the elongated element by an external magnetic field. The device tip is preferably arranged at the distal end of the elongated element. The device tip is configured to bend by an external magnetic field to allow manipulation of the elongated element.

[0013] The end of the steerable device opposite the tip of the device, ie, the proximal end of the steerable device, is designed to be retained outside the body of a mammal for external manipulation, such as by a physician or a robot.

[0014] In the context of the present disclosure, distal refers to a position or direction on one side of the operating site, ie, on the patient side, while proximal refers to a position or direction on the opposite side, ie, away from the patient side and the side where the operator is located.

[0015] In particular, the elongated element terminates at a distal end of the device tip. The distal tip may contain or carry a measuring device and / or an actuating device, such as a camera, a sensor, an ablation tip, a needle, an electrode, etc. The device may contain a cavity that allows fluids, needles, coils, drugs, biopsy tools, and the like to be delivered to a target site.

[0016] The device tip comprises a plurality of segments, each segment comprising a segment body and a segment interface arranged at each longitudinal end of the segment body, that is, each segment has two segment interfaces, namely a distal segment interface and a proximal segment interface.

[0017] In addition, the device tip includes multiple connectors, each connector includes a connector body and a connector interface arranged at each longitudinal end of the connector body, that is, each connector has two connector interfaces, namely a distal connector interface and a proximal connector interface.

[0018] A plurality of segments and a plurality of connectors are arranged along the longitudinal axis of the device, each connector connecting two consecutive segments in a manner that allows the segments and connectors to move relative to each other in an assembled state to allow bending of the device tip.

[0019] The plurality of segments and the plurality of connectors may be arranged in a tubular portion at the tip of the device, the tubular portion being designed to limit radial movement of the segments and the connectors in the longitudinal axis of the device. The tubular portion may be in the form of a tube enclosing the plurality of connectors and the plurality of segments, the tube being attached to the distal end of the elongated element, or formed as a hollow extension of the elongated element, more specifically, the tube being a hollow extension of the outer cladding of the elongated element in the longitudinal direction. In particular, the tubular portion may be part of the cladding. The tubular portion maintains alignment or at least approximate alignment of the plurality of connectors and the plurality of segments in the longitudinal direction of the device.

[0020] According to the present invention, each pair of connector interfaces and segment interfaces has complementary shapes, allowing rotational movement relative to each other and forming a connection to keep the connector and the segment aligned along the longitudinal axis in the mating state. In addition, according to the present invention, the magnetic element at least partially forms the segment body or the connector body or both.

[0021] Complementary shapes refer to shapes that complement each other, one shape fitting the other shape exactly or with enough clearance to allow relative movement between each other. For example, complementary parts can be matching parts that fit exactly with each other, like a ball and a socket in a spherical hinge connection. In contrast, a spherical part and a cylindrical tube do not form a complementary shape, the spherical part being enclosed in a cylindrical tube whose inner diameter corresponds to the diameter of the sphere.

[0022] The connector interface and the segment interface having complementary shapes improve the stability of the device tip, especially the stability of the device tip in the longitudinal direction. The complementary shapes limit sliding and improve the force transmission at the interface between the connector and the segment because the connector and the segment have an increased contact surface. At the same time, because the connector interface and the segment interface are designed to allow the connector and the segment to rotate relative to each other, the bending of the device tip is not unduly restricted.

[0023] Furthermore, since part of the function of the tubular portion to maintain alignment of the segments and connectors is transferred to the connector interface and the segment interface, the thickness of the tubular portion can be reduced. Accordingly, the diameter of the device can be reduced. Alternatively, the thickness of the tubular portion and the diameter of the device can remain unchanged, and in this case, the longitudinal alignment of the segments and connectors in the device tip is improved.

[0024] Magnetic materials are fragile and have limited resistance to mechanical constraints present at the interface between the segment and the connector. Therefore, it is advantageous when the magnetic element is formed as the connector body, the segment body, or both, or forms a part of the connector body, the segment body, or both, because the mechanical constraints present in the connector body, the segment body are significantly smaller. It can be seen that the device tip has improved force transmission at the interface between the connector and the segment without being limited by the mechanical properties of the magnetic material. Therefore, there is no need to provide a strong magnetic element designed to resist the mechanical constraints at the interface. This design also allows the diameter of the manipulable device to be reduced. At the same time, the magnetic material can be distributed over the length of the device tip in the form of magnetic elements associated with the segments and the connector, or the magnetic material forms the segments and the connector, or the magnetic material forms a part of the segments and the connector.

[0025] Furthermore, the volume of magnetic material can be adjusted by designing the device tip to include magnetic elements distributed over the segment body, the connector body, or both. This feature advantageously allows the design of steerable devices that can be effectively steered in a magnetic field.

[0026] In a preferred embodiment, a magnetic element is associated with each segment and connector to maximize the volume of magnetic material.

[0027] In a preferred embodiment, the connection is a spherical articulated connection, which includes a sphere and a socket, which are arranged to connect the segment interface to the adjacent connector interface in the direction of the longitudinal axis of the device, and when the device end is bent, an inclination angle α is formed between the segment longitudinal axis of the segment and the connector longitudinal axis of the connector adjacent to the segment, wherein the inclination angle is measured in the plane formed by the segment longitudinal axis and the connector longitudinal axis. The spherical articulated connection forms a plurality of spherical articulated connections. The sphere and the socket together form interlocking parts of a snap-fit ​​assembly, thereby forming a spherical articulated connection. This method of connection avoids the risk of slipping and further improves the force transmission at the interface between the connector and the segment without compromising the bending of the tip of the device. In addition, this is a particularly effective connection between the segment and the connector to avoid kinking of the manipulable device, making it possible to navigate in an open space in a stable manner.

[0028] In a preferred embodiment, the spherical articulated connection is formed in such a way that the segment interfaces each comprise a sphere and the connector interfaces each comprise a socket designed to receive a sphere.

[0029] More preferably, the segment interfaces are each formed by a sphere and the connector interfaces are each formed by a ball and socket, to form a particularly compact assembly of segments and connectors, thereby allowing greater bending of the device tip.

[0030] It must also be noted that embodiments are also possible in which the segment interfaces all comprise a ball socket and the connector interfaces all comprise a sphere. In the same way, embodiments are also conceivable in which the segment has a first segment interface comprising a sphere and a second segment interface, the second segment interface being arranged at the end of the segment opposite to the first segment interface comprising the ball socket. In this embodiment, the connectors are formed in the same way, i.e. each connector has a sphere and a ball socket at opposite ends of the connector. In a particularly preferred embodiment, the connector and the segment have the same form and are interchangeable, which simplifies the production of the tip of the device.

[0031] Preferably, the segments and the connectors have an axial symmetry to provide simplified production.

[0032] The socket has a socket wall defined by a socket outer surface and a socket inner surface. The sphere has a sphere outer surface, and the sphere may be solid. In the case where the sphere is hollow, the sphere has a sphere wall defined by a sphere outer surface and a sphere inner surface.

[0033] In a preferred embodiment, each spherical articulated connection is formed so that the outer surface of the sphere is spherical and the inner surface of the socket is spherical, wherein the sphere extends axially beyond the equatorial plane of the socket in a direction from the sphere facing the socket, the socket has an opening, the opening diameter of the opening is smaller than the spherical diameter of the sphere, and the edge area of ​​the socket includes an opening forming a detent, which is used to keep the sphere and the socket in a mating state. The opening of the socket is preferably located in a plane parallel to the equatorial plane of the socket and has a circular shape. Other embodiments of the spherical articulated connection can also be used. The advantage of a spherical sphere is that the spherical articulated connection can rotate freely in space. Note that the term "spherical" also includes shapes that are almost spherical within the production tolerance range.

[0034] If it is necessary to prevent bending in certain axes, it is also conceivable to use a sphere having an oval form or even a cylindrical shape in the ball joint connection.

[0035] Preferably, the socket has at least one cutout extending axially from the opening in a direction opposite to the opening. The cutout allows the ball to be inserted more easily into the socket to simplify assembly of the tip of the device.

[0036] In a preferred embodiment, each segment and each connector has a hole extending in the direction of the longitudinal axis of the device, which hole forms a hole of a plurality of holes, and in the assembled state, the plurality of holes form a conduit extending axially through the plurality of segments (i.e. through the segment body and the segment interface) and through the plurality of connectors (i.e. through the connector body and the connector interface). The conduit can be used to provide access to a target location for a small tool or the like, or the conduit accommodates a tube to form a lumen allowing, for example, the delivery of a fluid to a target location.

[0037] In a preferred embodiment, the magnetic element at least partially surrounds the segment body or the connector body or both. Preferably, the magnetic element is axisymmetric, the magnetic element being in the form of a cylinder arranged around the longitudinal axis of the device to simplify manipulation in a magnetic field. For example, if the volume of magnetic material must be increased, the magnetic element can extend along the entire axial length of the segment body and the connector body, respectively.

[0038] In other preferred embodiments, the magnetic element may be at least partially embedded in the segment body or the connector body or both. Advantageously, the embedded magnetic element helps to reduce the diameter of the steerable device.

[0039] In a preferred embodiment, the magnetic element is formed from a permanent magnetic material to allow magnetic manipulation of the device tip.

[0040] In a preferred embodiment, the segments and parts of the connector that do not form the magnetic element are constructed of magnetically non-responsive material to avoid interaction with the magnetic field used to manipulate the magnetic element. This embodiment may be used when only a small amount of magnetic material is required to enable navigation of the steerable device.

[0041] In a preferred embodiment, the segments and parts of the connector that do not form the magnetic element consist of a ferrous material, for example ferrous steel, which is magnetized by the permanent magnets, thereby helping to increase the total volume of magnetic material. The interaction with the magnetic field used to manipulate the magnetic element is thereby enhanced, thereby improving manipulation.

[0042] The magnetically non-responsive material can be a non-ferromagnetic material to avoid interaction with the magnetic field used to manipulate the manipulable device. However, the magnetically non-responsive material can also be a material that is diamagnetic or paramagnetic, and its magnetic contribution is negligible compared to the magnetic contribution of the magnetic elements to the manipulation of the device. These properties make the interaction of the segments and connectors with the magnetic field orders of magnitude smaller than the interaction of the magnetic elements with the magnetic field, and therefore, these properties can be ignored when manipulating the manipulable device in a mammal.

[0043] The segments and connectors may be constructed of materials suitable for biomedical applications, such as polymeric materials such as nylon, polyurethane, polyethylene, polyether block amides (e.g., those known under the trade name ), POM, PEEK or silicone. Alternatively, the segments and connectors may be made of metal, such as steel, stainless steel, titanium, aluminum or any other biocompatible metal. For the magnetic elements, materials such as ferrite, neodymium iron boron (NdFeB), aluminum nickel cobalt (AlNiCo), samarium cobalt (SmCo), iron chromium cobalt (FeCrCo) or any other suitable ferromagnetic material or alloy may be used.

[0044] In a preferred embodiment, the plurality of connectors or the plurality of segments or both are formed from a one-piece part. This simple design simplifies assembly and reduces production costs.

[0045] In a preferred embodiment, the connector consists of a separate component in the form of a connector body, preferably formed as a tubular element, and a separate component in the form of a connector interface, which is inserted into the connector body at each end.

[0046] In another preferred embodiment, the segment is composed of a separate component in the form of a segment body that is preferably formed as another tubular element and a separate component in the form of a segment interface, and the segment interface is inserted into the segment body at each end of the segment body. The individual components can be kept in an assembled state by applying force along the longitudinal direction of the device at both ends of the tubular portion containing multiple segments and multiple connectors. The individual components can also be kept in an assembled state by mechanical means including gluing or welding. In order to easily insert into the segment body and the connector body, the segment interface and the connector interface can respectively have an insertion portion for guiding the insertion, which is respectively arranged on one side thereof facing the segment body and the connector body.

[0047] In another preferred embodiment, the connector and the segment are each composed of separate parts.

[0048] Advantageously, starting from separate components allows different configurations of connectors and / or segments to be achieved without significantly increasing the production complexity of the device tip. For example, by using segment bodies and connector bodies with different lengths, respectively, while maintaining the same segment interface and connector interface, respectively, segments and connectors of various lengths can be achieved. This also allows assembling segments and connectors that include different materials for the segment body and connector body, respectively. In particular, the segment body and connector body are composed of magnetic materials, and the segment interface and connector interface are respectively composed of materials with different mechanical properties, such as materials that allow the formation of a spherical articulated connection.

[0049] In an even more preferred embodiment, the segment body and the connector body may have the same design, so that the segment body and the connector body form interchangeable parts, thereby reducing the number of different parts and simplifying the production of the device tip.

[0050] In a more preferred embodiment, the tubular element or the other tubular element or both form the magnetic element.Since the magnetic element forms both the segment body and the connector body, this preferred embodiment allows a further reduction in the diameter of the steerable device.

[0051] The magnetic element may also be formed as a semi-cylindrical shell, or more generally as part of a cylindrical shell assembled with the segment body and / or the connector body.

[0052] In a preferred embodiment, the device tip comprises a first group of segments and connectors preferably arranged at the distal end, the segments and connectors of the first group having a first length, and a second group of segments and connectors preferably arranged at the proximal end, the segments and connectors of the second group having a second length, the first length and the second length being measured along the longitudinal axis of the device, the first length being smaller than the second length. This arrangement allows the formation of two regions in the device tip, namely: a distal region of the device tip comprising the first group allowing greater bending (i.e., a short radius of curvature of the device) to facilitate navigation of the distal region, and a proximal region of the device tip comprising the second group allowing less bending (i.e., a larger radius of curvature and greater axial stiffness).

[0053] It is also conceivable to provide segments with different lengths and connectors with different lengths, wherein the length and arrangement of the segments and connectors are defined according to the desired bending properties of the steerable device.

[0054] In a preferred embodiment, the device tip comprises a set of segments and connectors preferably arranged at the distal end, the set of segments and connectors having magnetic elements, and another set of segments and connectors preferably arranged at the proximal end, the other set of segments and connectors not having magnetic elements. This arrangement also allows the formation of two regions in the device tip, namely: a distal region of the device tip, which comprises a group of magnetic elements that allow the distal region to navigate under the action of a magnetic field, and a proximal region of the device tip, which comprises another group that does not respond to magnetic fields but has greater axial stiffness.

[0055] Advantageously, one can envisage an embodiment comprising a combination of two previously preferred embodiments, namely a distal region comprising segments and connectors having a shorter length and having magnetic elements, and a proximal region comprising segments and connectors having a longer length and having no magnetic elements, in order to enhance the effects obtained above.

[0056] In a preferred embodiment, the ball of the spherical articulation connection, preferably each ball of a plurality of spherical articulation connections, for the sake of simplifying the manufacturing, is located on an axially extending neck, and for the segments and the connector of the spherical articulation connection of the plurality of spherical articulation connections, the inclination angle α is limited to a maximum inclination angle α_max, which is the maximum inclination angle α_max reached when the neck is in contact with an edge region of the ball socket of the spherical articulation connection due to the relative movement of the segment with respect to the connector, the edge region serving as a stop for the inclination of the segment with respect to the connector. If the segment carries the ball in the spherical articulation connection, the neck can be in the form of a cylinder protruding longitudinally from the body of the segment (arranged with the longitudinal axis of the segment as the center), or if the connector carries the ball in the spherical articulation connection, the neck can be in the form of a cylinder protruding longitudinally from the body of the connector (arranged with the longitudinal axis of the connector as the center). For one embodiment, the maximum inclination angle α_max can be predetermined in particular based on the opening diameter of the ball socket and the neck diameter of the neck. This arrangement avoids excessive bending of the device tip, thereby reducing the risk of the ball being pulled out of its corresponding socket, or reducing the risk of kinks forming in tubes or wires passing through the internal channel. More preferably, all spherical articulated connections of the plurality of spherical articulated connections are formed according to the embodiments described above to simplify assembly and production of the device tip.

[0057] In a preferred embodiment, the neck has a radially extending collar which is arranged near the contact point where the edge area of ​​the socket abuts. Advantageously, the collar prevents further bending of the spherical articulated connection by blocking the edge area at the contact point in the longitudinal direction. It is also possible to provide a collar extending radially from the ball.

[0058] In a preferred embodiment, in order to simplify the manufacturing, the ball of the spherical articulation connection, preferably each ball of a plurality of spherical articulation connections, is truncated on the side of the ball facing the socket by a first plane, which is preferably parallel to the equatorial plane of the ball, thereby forming a ball abutment surface, and the corresponding sockets of the plurality of spherical articulation connections have a flat socket bottom on their side facing the ball, which is preferably parallel to the equatorial plane of the socket, and for each spherical articulation connection segment and the connecting piece of the plurality of spherical articulation connections, the inclination angle α is limited to a maximum inclination angle α_max, which is the maximum inclination angle α_max reached when the ball abutment surface is in a contact position with the socket bottom due to the relative movement of the segment with respect to the connecting piece of the spherical articulation connection, which contact position serves as a stop for the inclination of the segment with respect to the connecting piece. For one embodiment, the maximum inclination angle α_max can be predefined in particular based on the axial distance between the ball abutment surface and the socket position measured when the longitudinal axis of the segment and the longitudinal axis of the connecting piece are parallel to each other. This arrangement also avoids the device tip from bending too much, thereby reducing the risk of the ball being pulled out of its corresponding socket.More preferably, all spherical articulation connections of the plurality of spherical articulation connections are formed according to the embodiments described above, to simplify assembly and production of the device tip.

[0059] In a preferred embodiment, the outer surface of the socket has a structured area, and the space formed between the socket and the tubular part in the assembled state of the device tip is filled with a granular material, the tubular part at least covering the plurality of segments and the plurality of connectors, wherein when the space is under vacuum, the granular material locks the relative positions of the plurality of segments and the plurality of connectors in a locked state. To this end, the tubular part is connected to a device for applying a vacuum to the gap.

[0060] The tubular portion may be designed to form an airtight space with a valve at the proximal end of the manipulable device to allow connection to a vacuum pump. Preferably, the tubular portion fits tightly to the surface of the segment body and the connector body, and a gap is formed between the tubular portion and the gap at the spherical hinge connection between the segment body and the connector body, in particular, a gap is formed between the outer surface of the ball socket of the spherical hinge connection and the tubular portion.

[0061] A structured area or structured area is understood to be a surface with a pattern, which may be a geometric feature designed to give the area a specific function. In this case, the structured area increases the friction between the granular material and the socket, for example by blocking the granular material in a depression formed in the structured area or between protrusions. When the gap is under vacuum (i.e., under a pressure lower than atmospheric pressure), the coating is pressed against multiple segments and multiple connectors, and is also pressed against the granular material provided between the segments and the connectors. As a result, the friction between the granular material itself and between the granular material and the socket hinders the relative movement of the segments and the connectors. For this purpose, the gap is connected to a device for applying a vacuum.

[0062] Preferably, the structured surface has a structure in the form of a plurality of concentric grooves spaced apart from one another, viewed in the longitudinal direction, each groove extending circumferentially in a plane parallel to the equatorial plane of the socket.

[0063] In a preferred embodiment, the segment and the connector each include at least three channels, which are arranged in the corresponding holes forming the pipeline in a manner of equal circumferential distances from each other, and each of the at least three channels forms a through hole, wherein in the assembled state, the through hole of the segment and the through hole of the connector are aligned, and the through hole forms at least three guides passing through multiple segments and multiple connectors, and the at least three guides are designed to allow the passage of a pull wire, wherein the pull wire is fixed in the distal region of the tip of the device, and the pull wire is designed to be pulled proximally to lock the relative positions of multiple segments and multiple connectors. Due to the pulling of the pull wire proximally, the friction at the spherical hinge connection increases, thereby locking the relative positions of the segment and the connector. The at least three channels can be arranged in the segment, or arranged in the segment body or arranged in the segment interface, and arranged in the connector or arranged in the connector body or arranged in the connector interface. At least three channels are required to block all degrees of freedom at the tip of the device. The at least three through holes of each segment and each connector form a plurality of through holes, wherein in the assembled state, the plurality of through holes are aligned to form at least three guides. Each guide can be regarded as a path virtually formed by aligning through holes in the plurality of through holes.

[0064] In other embodiments, the at least three channels may be in the form of lugs and are respectively arranged in planes perpendicular to the longitudinal axis of the segment and the longitudinal axis of the connector to allow symmetrical action of forces applied to the inner surface of the ball and press the outer surface of the ball against the inner surface of the socket.

[0065] Advantageously, the segment interface (particularly the ball or ball neck) may also include a radially extending collar which is arranged near the edge region of the connector interface (particularly the socket) in contact therewith. It is also conceivable that the collar is part of the segment body.

[0066] In a preferred embodiment, the segment body and the connector body each include at least three channels at their distal ends and at least three channels at their proximal ends. Therefore, each guide wire is supported by two channels in each segment and each connector, thereby improving the guide wire's guideability and safety in the event of a channel breakage.

[0067] In a preferred embodiment, a cannula is arranged in the pipeline, the cannula comprising a braided sheath and a spring element covered by the braided sheath, wherein in the relaxed state of the cannula, the outer diameter of the cannula is equal to or smaller than the inner diameter of the pipeline, the outer diameter of the spring element is equal to or smaller than the inner diameter of the braided sheath, the cannula extends from a distal cannula end fixed in the distal region of the tip of the device to a proximal cannula end, the proximal cannula end being designed to be pulled proximally to switch the cannula from the relaxed state to a stretched state, in which the relative positions of the plurality of segments and the plurality of connectors are locked. In order to prevent the braided sheath from collapsing and / or shrinking in diameter when the operator pulls the cannula, the spring element (which may be a wire spring) is designed to keep the inner diameter of the braided sheath constant or at least approximately constant. Preferably, the distal end of the spring element is fixed in the distal region of the tip of the device, preferably at the same position as the distal cannula end. For example, the sleeve distal end can be fixed to the most distal segment of the arrangement formed by multiple segments and multiple connectors (or can be fixed to the most distal connector of the arrangement formed by multiple segments and multiple connectors as the case may be). The distal end of the spring element can be fixed at the same height. By pulling the braided sheath, the braid of the braided sheath moves relative to each other and tends to align with the direction of the pulling force. Therefore, the diameter of the braided sheath tends to become smaller and presses against the outer surface of the spring element arranged inside the braided sheath, and the spring element at least roughly keeps the shape of the braided sheath. When the braid is aligned along the pulling force, the sleeve presses multiple contacts in the segment interface, particularly multiple contacts in the sphere against the connector interface (particularly against the ball socket), thereby increasing the friction at the spherical hinged connection, and the segment and the connector are locked relative to each other.

[0068] This arrangement may be used as an alternative to using the aforementioned pull wires.

[0069] In a preferred embodiment, the spherical articulated connection has a socket, the socket comprising a through hole extending in a direction having a radial component, the through hole being formed in the area of ​​the socket, in which the inner surface of the socket contacts the outer surface of the sphere in the assembled state, and in which the socket comprises a plug designed to be inserted into the through hole to form a protrusion protruding from the inner surface of the socket and contacting the outer surface of the sphere, thereby increasing the friction between the sphere and the socket when the pipeline is in a vacuum to lock the relative positions of multiple segments and multiple connectors. To this end, the pipeline is connected to a device for applying vacuum. In this embodiment, the coating is designed to form an airtight space with the valve at the proximal end of the manipulable device to allow connection to a vacuum pump. In a relaxed state (i.e., a state in which no vacuum is applied to the top of the device), the plug inserted into the through hole allows the sphere to move freely in the socket. After applying vacuum, the plug is sucked into the through hole until the plug contacts the outer surface of the sphere, thereby increasing the friction between the sphere and the socket.

[0070] Preferably, the through hole extends in radial direction to simplify production.

[0071] Preferably, the through holes (preferably at least three through holes) are arranged in a plane parallel to the equatorial plane of the inner surface of the socket at equal circumferential distances from each other to allow a symmetrical distribution of the forces acting on the ball. The stiffness in the locked state can be determined according to the number of through holes and plugs used.

[0072] In a preferred embodiment, each spherical articulated connection of a plurality of spherical articulated connections comprises a ball and a ball socket, the ball and the ball socket comprising a torque transmission device in the form of a radially outwardly protruding boss and a groove, the boss being inserted into the groove in the assembled state, the boss and the groove being designed in a manner to cooperate with each other to allow torque to be transmitted between the ball and the ball socket, wherein the ball comprises a radially outwardly protruding boss and the ball socket comprises a groove, or the ball comprises a groove and the ball socket comprises a radially inwardly protruding boss.

[0073] Preferably, moreover, the shape of the boss and the shape of the groove and the relative position of the boss and the groove are dimensioned so that when the segment and the connection piece move relative to each other, the groove and the boss always remain at least partially engaged. This feature avoids, for example, a loss of torque transmission when the inclination angle is too sharp. In fact, an inclination angle that is too sharp (too steep) leads to an increase in the distance between the boss and the groove, in particular in the area of ​​the spherical articulated connection opposite to this too sharp inclination angle.

[0074] In a preferred embodiment, the boss is a radially projecting pin, preferably cylindrical, and the recess is an axial slot, preferably in the form of an elongated rectangle with rounded corners, the width of which is dimensioned to allow play between the pin and the edges of the recess in the circumferential direction.

[0075] In a preferred embodiment, the groove (preferably in the form of a slit) is closed on the side facing the spherical hinge connection to avoid the boss (preferably in the form of a pin) sliding out of the groove. This arrangement provides improved safety during navigation while allowing torque transmission.

[0076] In a preferred embodiment, the plurality of protrusions and the plurality of grooves are arranged at equal circumferential distances from each other when both are viewed in a plane perpendicular to the longitudinal axis of the device. The symmetry created by this arrangement simplifies navigation of the device.

[0077] In a preferred embodiment, the boss has the form of an elongated protrusion in the form of a finger extending axially on the inner surface of the socket or the outer surface of the socket, and the groove is formed as an axial slot in the ball or socket. The groove has a shape complementary to the elongated protrusion (preferably in the form of an elongated rectangle) and has a width dimension that allows clearance between the protrusion and the groove in the circumferential direction.

[0078] Furthermore, the length of the groove and the length of the elongated projection are dimensioned so that the groove and the elongated projection remain at least partially engaged when the segment and the connector move relative to each other. This feature avoids loss of torque transmission, for example when the tilt angle is too sharp.

[0079] In a preferred embodiment, the spherical articulated connection of a plurality of spherical articulated connections, in order to simplify production, preferably all spherical articulated connections have a ball and a socket, the outer surface of the ball has a structured area, and the inner surface of the socket has another structured area to increase the friction between the ball and the socket, especially when the plurality of segments and the plurality of connecting parts are in a locked state. This arrangement increases the locking effect in the locked state, because the friction between the outer surface of the ball and the inner surface of the socket further prevents the relative movement of the segments and the connecting parts. BRIEF DESCRIPTION OF THE DRAWINGS

[0080] Figure 1 shows a schematic perspective view of a distal portion of a steerable device according to a first embodiment of the present invention;

[0081] Figure 2 a schematic perspective view showing a portion of a tip of a device according to a second embodiment of the invention;

[0082] Figure 3 Shown according to Figure 2 A cross-sectional view of a portion of a tip of a device of an embodiment of the present invention;

[0083] Figure 4 a schematic perspective view showing a portion of a tip of a device according to a third embodiment of the invention;

[0084] Figure 5 Shown according to Figure 4A cross-sectional view of a portion of a tip of a device of an embodiment of the present invention;

[0085] Figure 6 showing a cross-sectional view of a portion of a tip of a device according to a fourth embodiment of the present invention;

[0086] Figure 7 a schematic perspective view showing a portion of a tip of a device according to a fifth embodiment of the invention;

[0087] Figure 8 Shown according to Figure 7 A cross-sectional view of a portion of a device tip having a coating and particulate material according to an embodiment of the present invention;

[0088] Fig. 9 A cross-sectional view showing a spherical hinge connection for the tip of a device according to the invention;

[0089] Fig.10 Shown according to Fig. 9 A schematic perspective view of a spherical hinge connection of an embodiment of;

[0090] Fig.11 shows a schematic perspective view of a spherical articulated connection for a tip of a device according to the invention;

[0091] Fig.12 Shown according to Fig.11 A cross-sectional view of a spherical hinge connection of an embodiment of the present invention;

[0092] Fig.13 A cross-sectional view showing a spherical hinge connection for the tip of a device according to the invention;

[0093] Fig.14 shows a schematic perspective view of a spherical articulated connection for a tip of a device according to the invention;

[0094] Fig.15 Shown according to Fig.14 A cross-sectional view of a spherical hinge connection of an embodiment of the present invention;

[0095] Fig.16 shows a schematic perspective view of a spherical articulated connection for a tip of a device according to the invention;

[0096] Fig.17 Shown according to Fig.16 A cross-sectional view of a spherical hinge connection of an embodiment of; and

[0097] Fig.18 A schematic perspective view of a distal portion of a steerable device without covering according to a sixth embodiment of the present invention is shown. DETAILED DESCRIPTION

[0098] A first embodiment of the manipulable device 10 according to the present invention is configured as follows Figure 1 Pipeline shown.

[0099] The steerable device 10 has a structure that is at least approximately rotationally symmetrical with respect to its longitudinal axis, the structure having a narrow circular cross-section proportional to its length. The steerable device comprises a flexible elongated element 12 in the form of an elongated shaft, the longitudinal axis of the flexible elongated element 12 corresponding to the longitudinal axis L of the steerable device 10, the flexible elongated element 12 having a circular cross-section and extending over the length of the steerable device 10. The steerable device 10 has Figure 1 A proximal end (not shown) and a distal end 14 located on the operation site side.

[0100] In addition, the steerable device 10 includes a flexible device tip 20 disposed at the distal end 16 of the elongated element 12. The device tip 20 is configured to be bent by an external magnetic field to allow the elongated element to be steered. In particular, the elongated element 12 terminates at the distal end of the device tip 20. The device tip 20 bends under the action of the magnetic field to be in a deformed state.

[0101] The device tip 20 includes a tubular portion 22 and a plurality of connectors 24 and a plurality of segments 26 .

[0102] The tubular portion 22 is formed as a tube covering the plurality of connectors 24 and the plurality of segments 26 and extends distally from the elongated element 12 in the longitudinal direction, flush with the covering 32 of the elongated element. Fig.18 The embodiment shown in FIG. Figure 1 The embodiment of FIG. 1 has the same general structure, but the cladding 32 and the tubular portion 22 are not shown.

[0103] The tubular portion 22 keeps the segments 24 and the connectors 26 aligned in the steerable device 10 along the longitudinal direction L. Furthermore, each connector connects two consecutive segments in a manner that allows the segments and connectors to move relative to each other in their assembled state, the connection being in the form of a spherical articulated connection between the segments and the connectors.

[0104] exist Fig.18In an embodiment, the device tip 20 includes a first group 35 of segments and connectors arranged at the distal end, the segments and connectors of the first group having magnetic elements 34 and having a first length measured along the longitudinal axis of the device. The device tip 20 also includes a second group 37 of segments and connectors arranged at the proximal end, the segments and connectors of the second group not having magnetic elements and having a second length measured along the longitudinal axis L of the device, the first length being less than the second length. Therefore, there are two regions in the device tip 20, namely a distal region of the device tip and a proximal region of the device tip, the distal region including the first group 35 having magnetic elements that allow the distal region to navigate under the action of a magnetic field, and the proximal region including the second group 37 that does not respond to the magnetic field but has a greater axial stiffness.

[0105] from Figure 2 Looking at the cross section AA, according to Figure 2 and Figure 3 The portion of the tip of the device of the second embodiment disclosed in the embodiment includes a plurality of segments 24, each segment including a segment body 36 and segment interfaces 38a and 38b provided at each longitudinal end of the segment body 38. The segments 24 each have two segment interfaces, namely a distal segment interface 38a and a proximal segment interface 38b, wherein the distal orientation and the proximal orientation have been arbitrarily selected and are Figure 2 and Figure 3 and shown in the figure below.

[0106] Furthermore, the device tip includes a plurality of connectors 26, each connector including a connector body 40 and connector interfaces 42a and 42b disposed at each longitudinal end of the connector body 40. The connectors 26 each have two connector interfaces, namely a distal connector interface 42a and a proximal connector interface 42b.

[0107] A plurality of segments and a plurality of connectors are arranged along the device longitudinal axis L, each connector 26 connecting two consecutive segments 24 in a manner allowing the segments and connectors to move relative to each other in their assembled state to allow bending of the device tip.

[0108] The plurality of segments 24 and the plurality of connectors 26 may be arranged in a tubular portion that is disposed between the tubular portion and the tubular portion. Figure 2 and Figure 3 and subsequent figures, but are not shown in Figure 8 As shown in .

[0109] Each pair of connector interfaces 42a and 42b and segment interfaces 38a and 38b have complementary shapes to allow rotational movement relative to each other and form a connection, which is in the form of a spherical hinge connection to keep the connector 26 and segment 24 aligned along the longitudinal axis in the mating state. At present, the segment 24 and the connector 26 have axial symmetry.

[0110] The spherical hinge connections each include a ball 44 and a socket 46, which are arranged to connect the segment interfaces 38a and 38b to the adjacent connector interfaces 42b and 42a, respectively, in the direction of the device longitudinal axis L. When the device end is bent, an inclination angle α is formed between the segment longitudinal axis Ls of the segment and the connector longitudinal axis Lc of the connector adjacent to the segment. The inclination angle α is measured in the plane formed by the segment longitudinal axis Ls and the connector longitudinal axis Lc.

[0111] The ball-jointed connection forms a plurality of ball-jointed connections. The ball 44 and the ball socket 46 together form interlocking parts of a snap-fit ​​assembly, thereby forming a ball-jointed connection.

[0112] In the disclosed embodiment, the ball-and-socket joints are formed such that the segment interfaces 38 a and 38 b each include a ball 44 , and the connector interfaces 42 a and 42 b each include a socket 46 designed to receive the ball 44 .

[0113] The sockets 46 each have a socket wall 50 defined by a socket outer surface 52 and a socket inner surface 54. The balls 44 are hollow and each have a ball wall 60 defined by a ball outer surface 62 and a ball inner surface 64.

[0114] Each spherical hinge connection is formed such that the outer surface 52 of the ball is spherical and the inner surface 64 of the socket is spherical. The ball 44 extends axially beyond the equatorial plane Ps of the socket in the direction from the ball to the socket, and the socket 46 has an opening 66, the opening diameter of the opening 66 is smaller than the spherical diameter of the ball, and the edge area of ​​the socket includes an opening forming a stop portion, which is arranged to keep the ball and the socket in a mating state. The opening of the socket is preferably located in a plane parallel to the equatorial plane of the socket and has a circular shape.

[0115] For the sake of completeness, it is noted that the equatorial plane Ps of the socket 46 extends perpendicular to the segment longitudinal axis Ls and includes the center of the sphere defined by the socket inner surface 54. Similarly, the equatorial plane Pb of the sphere 44 extends perpendicular to the connector longitudinal axis Lc and includes the center of the sphere defined by the sphere outer surface 64.

[0116] The connector 26 is made of a one-piece part, wherein the connector body 40 is each limited to a narrow part connected to the connector interface, here in particular a ball socket. The segments 24 are each made of a separate part in the form of a segment body 36 formed as a tubular element and segment interfaces 38a and 38b, wherein the segment interfaces 38a and 38b are inserted into the segment body 36 at each end of the segment body.

[0117] In order to facilitate insertion into the segment body 36 , the segment interfaces 38 a and 38 b have an insertion portion 67 for guiding the insertion, and the insertion portion 67 is arranged on a side thereof facing the segment body 36 .

[0118] Each segment 24 and each connector 26 has a hole 65, which extends in the direction of the longitudinal axis L of the device and forms a plurality of holes, and the plurality of holes form a pipe 69, which in the assembled state extends axially through a plurality of segments, i.e., through the segment body and the segment interface, and through a plurality of connectors, i.e., through the connector body and the connector interface.

[0119] The magnetic element 34 is associated with the segment body 36. At present, the magnetic element 34 is associated with the segment body in the form of a magnetic tube forming the segment body itself, ie the segment interfaces 38a and 38b are inserted into the magnetic tube.

[0120] The segment interfaces 38a and 38b have respective collars 68a and 68b which extend radially outward and are designed to form abutments which limit insertion of the segment interfaces 38a and 38b into the segment body 36 at the distal and proximal sides thereof when the segments are assembled.

[0121] At the same time, the size and design of the collar on its side facing the connector interface forms a contact point against which the edge region of the socket can rest when the device tip is bent and a maximum inclination angle α_max is reached.

[0122] As in Figure 4 As seen in section AA, according to Figure 4 and Figure 5 The portion of the device tip of the third embodiment disclosed in has a similar overall structure to the second embodiment. For the sake of simplicity, only the differences are discussed, and the same components or components having the same functions as the second embodiment are represented by the same reference numerals.

[0123] The segments 24 of the third embodiment are identical to the segments of the second embodiment. In contrast to the second embodiment, the connectors 26 are each formed of a separate component, comprising a connector body 40 formed as a tubular element and connector interfaces 42a and 42b, wherein the connector interfaces 42a and 42b are inserted into the connector body 40 at each end of the segment body.

[0124] In order to facilitate insertion into the connector body 40 , the connector interfaces 42 a and 42 b have an insertion portion 70 for guiding the insertion, and the insertion portion 70 is arranged on a side thereof facing the connector body 40 .

[0125] To make it easier to assemble the ball-jointed connection, the connector interfaces 42a and 42b (specifically the sockets) have at least one cutout 72 extending axially from the socket opening 66 in the opposite direction of the opening. The cutout allows the ball to be inserted more easily into the socket because the cutout allows the socket to expand.

[0126] In addition to the magnetic element 34 associated with the segment body 36 in the form of a magnetic tube forming the segment body itself, a magnetic element 34 is also associated with the connector body, also in the form of a magnetic tube forming the connector body itself, i.e., into which both connector interfaces 42a and 42b are inserted. This embodiment allows increasing the magnetic material present in the tip of the device.

[0127] Figure 6 The fourth embodiment shown has a structure opposite to the second embodiment, particularly with regard to the assembly of the segments and the connectors and the arrangement of the magnetic elements.

[0128] The segments 24 are made of a one-piece part, wherein the segment bodies 36 are each limited to a narrow portion connected to the connector interfaces 38a and 38b, here in particular a ball socket. The connectors 26 are each made of a separate component, which includes a connector body 40 formed as a tubular element and connector interfaces 42a and 42b, wherein the connector interfaces 42a and 42b are inserted into the connector body 40 at each end of the connector body.

[0129] The connector interfaces 42a and 42b respectively have axial rings 72a and 72b, which extend radially outward and are designed to form abutment portions, which limit the insertion of the connector interfaces 42a and 42b into the connector body 40 at the distal and proximal sides of the connector body 40 when the connector is assembled.

[0130] At the same time, the size and design of the collar on its side facing the next connection element form a contact point against which the collar of the next connection element can abut when the device tip is bent, and the maximum inclination angle a_max is reached. This embodiment allows a firm abutment between the two collars.

[0131] In contrast to the second embodiment, the segment 24 does not have a magnetic element 34 , but a magnetic element 34 is associated with the connector body 40 , also in the form of a magnetic tube forming the connector body itself, ie into which the connector interfaces 42 a and 42 b are inserted.

[0132] from Figure 7 Looking at the cross section AA, Figure 7 and Figure 8The fifth embodiment shown differs from the previous embodiments primarily in that it comprises a locking mechanism for the positions of the segments and the connector relative to each other. This locking arrangement can also be used for the previously described embodiments.

[0133] In the fifth embodiment, the socket outer surface 52 has a structured area. The structured area has a pattern in the form of a plurality of concentric grooves spaced from each other as viewed in the longitudinal direction, each groove extending circumferentially in a plane parallel to the socket equatorial plane.

[0134] Furthermore, in the assembled state, a void 80 is formed by the gap between the sockets 42a and 42b and the tubular portion 22, wherein the void 80 is filled with a granular material 82. The tubular portion 22 surrounds the plurality of segments 24 and the plurality of connectors 26, and is designed to form an airtight space with a vacuum source (not shown), for example, through a valve located at the proximal end of the manipulable device to allow connection to a vacuum pump.

[0135] In this embodiment, when the space is under vacuum, the tubular portion is pressed against the plurality of segments and the plurality of connectors, and against the granular material provided between the segments and the connectors. Thus, friction between the granular material itself and between the granular material and the sockets impedes relative movement of the segments and the connectors.

[0136] Fig.10 It shows that Fig. 9 A schematic perspective view of a spherical hinge connection is shown in Fig.10 The spherical articulated connection comprises a locking mechanism for the positions of the segments and the connecting member relative to each other. This arrangement can also be used in the aforementioned embodiments.

[0137] The socket 46 of the spherical articulated connection comprises a through hole 84 extending in the radial direction and having a tapered shape extending inwards. The through holes 84 are arranged at equal circumferential distances from one another in a plane parallel to the equatorial plane of the inner surface of the socket to allow a symmetrical distribution of the forces acting on the ball 44. The through holes 84 are formed in the region of the socket in which, in the assembled state, the inner surface 54 of the socket is in contact with the outer surface 62 of the ball.

[0138] In addition, the socket 46 includes a plug 86 designed to be inserted into the through hole 84 , wherein the taper of the through hole is designed to block the plug in the through hole to allow a protrusion to be formed protruding from the socket inner surface 54 .

[0139] In an embodiment of the device tip using a spherical hinge connection, the tubular portion 22 surrounding the plurality of segments 24 and the plurality of connectors 26 is designed to form an airtight space with a vacuum source. In a relaxed state, i.e., in a state where a vacuum is not applied to the device tip, the plug 86 inserted into the through hole 84 allows the ball to move freely in the socket. As a result of the vacuum application, such as by a vacuum pump, the conduit 69 is under vacuum, and the plug 86 is sucked into the through hole 84 until the plug is blocked in the through hole and contacts the outer surface of the ball, thereby increasing the friction between the ball and the socket. Therefore, the relative positions of the plurality of segments and the plurality of connectors are locked.

[0140] Fig.11 Shown in Fig.11 When observed in section AA, Fig.12 Schematic perspective view of a spherical articulated connection shown in FIG. The spherical articulated connection comprises a locking mechanism for the positions of the segments and the connecting parts relative to each other. This arrangement can also be used in the aforementioned embodiments.

[0141] Both the segment and the connector comprise at least three channels 88 (in the form of lugs) arranged in the bore forming the conduit 69 and projecting radially inwards in the conduit. The lugs are arranged at equal circumferential distances from one another in planes perpendicular to the longitudinal axes of the segment and the connector, respectively, to allow symmetrical force application.

[0142] The at least three channels 88 each have a through hole 90. In the assembled state, the through holes 90 of the segments are aligned with the through holes of the connectors and form at least three guides that pass through the multiple segments and multiple connectors. The at least three guides are designed to allow each of the pull wires 91 (schematically shown in FIG. 1 ) fixed in the distal region of the tip of the device to be pulled out of the device. Fig.11 and Fig.12 The pull wire 91 is designed to be pulled proximally to lock the relative positions of the multiple segments and multiple connectors by increasing the friction between the outer surface 62 of the ball and the inner surface 54 of the socket at each location.

[0143] In this embodiment, the lugs are arranged in the segment interface 38b and the connector interface 42a. As a result, each guide wire 91 is supported by two lugs in each segment and each connector.

[0144] Fig.13 A cross-sectional view of a spherical articulated connection is shown, which includes a locking mechanism for the position of the segments and the connector relative to each other. This arrangement can also be used as an alternative to the aforementioned draw wire.

[0145] In this embodiment, a sleeve 94 is arranged in the pipe 69, and the sleeve includes a braided sheath 96 and a spring element 98 surrounded by the braided sheath 96. When the sleeve 94 is in a relaxed state, the outer diameter of the sleeve is equal to or less than the inner diameter of the pipe 69, and the outer diameter of the spring element 98 is equal to or less than the inner diameter of the braided sheath 96. The sleeve extends from a distal sleeve end (not shown) fixed in the distal region of the device tip to a proximal sleeve end (not shown). The proximal sleeve end is designed to be pulled proximally to convert from the relaxed state of the sleeve 94 to a stretched state, in which the relative positions of the multiple segments 24 and the multiple connectors 26 are locked. In order to prevent the braided sheath 96 from collapsing and / or shrinking in diameter when the operator pulls the sleeve, the spring element (which can be a wire spring) is designed to keep the inner diameter of the braided sheath constant or at least approximately constant. The distal end of the spring element is fixed in the distal region of the device tip at the same position as the distal sleeve end. The distal sleeve end can be fixed, for example, by gluing or mechanical means. In an embodiment comprising a spherical hinged connection, the distal sleeve end can be mechanically fixed to, for example, a distal sphere, or can be mechanically fixed to a distal joint of an arrangement formed by a plurality of segments and a plurality of connectors, as the case may be. In an embodiment comprising a distal segment consisting of a separate component in the form of a segment body and a segment interface, and the segment interface being configured to be inserted into the segment body, the distal sleeve end can be arranged in a manner protruding from the distal segment, wherein the distal sleeve end is fixed by clamping it between the distal segment interface and the segment body when the segment is installed. To this end, the distal sleeve end can extend radially outward, fold in the proximal direction, and be pulled through the segment interface in the proximal direction to cover the outer surface of the segment interface, so that when the segment is in the installed state, at least a portion of the distal sleeve end is clamped between the distal segment interface and the segment body. The same arrangement can also be applied to an embodiment comprising a distal connector consisting of a separate component in the form of a connector body and a connector interface.

[0146] Fig.14 It shows that Fig.15 A schematic perspective view of a spherical hinge connection is shown in Fig.14 The spherical articulated connection comprises a torque transmission device for transmitting torque between the segment and the connector along the tip of the device. This arrangement can also be used in the aforementioned embodiments.

[0147] In the present embodiment, the spherical articulated connection has a ball 44 and a socket 46, which includes torque transmission means in the form of a cylindrical pin 100 protruding radially outwards from the ball 44 and a groove 102. The groove 102 is an axial slot in the form of an elongated rectangle with rounded corners, the width of which is dimensioned so as to form a play in the circumferential direction between the edges of the pin and the groove. In the present embodiment, this play only allows the pin to contact in the groove 102 in a sliding contact manner. It should also be noted that the groove 102 is closed on the side facing the spherical articulated connection to prevent the pin 100 from sliding out of the groove.

[0148] An embodiment is also possible in which the groove 102 is open on the side facing the spherical hinge connection. In this case, however, the relative positions of the pin 100 and the groove 102 are dimensioned so that the groove 102 and the pin 100 always remain at least partially engaged when the segment 26 and the connecting piece 24 move relative to each other. This feature avoids loss of torque transmission, for example when the tilt angle α is too sharp.

[0149] In the assembled state, the pin 100 is inserted into the groove, wherein the pin 100 and the groove 102 are designed to cooperate with each other to allow the transmission of torque between the ball and the socket.

[0150] In the disclosed embodiment, three pairs of mutually engaged pins and grooves are provided, and these pins and grooves are arranged at equal circumferential spacing along a plane perpendicular to the longitudinal axis of the device (i.e., a plane perpendicular to the longitudinal axis of the segment in the case of a sphere, and a plane perpendicular to the longitudinal axis of the connecting member in the case of a ball socket).

[0151] Fig.16 It shows that Fig.17 A schematic side view of a spherical hinge connection is shown in FIG. Fig.16 The spherical articulated connection also includes a torque transmission device for transmitting torque between the segment and the connector along the tip of the device. This arrangement can also be used in the aforementioned embodiments.

[0152] In this embodiment, the spherical articulated connection has a ball 44 and a socket 46 , which includes torque transmission means including fingers 106 extending on the inner surface of the ball and the groove 102 .

[0153] The groove 102 is formed as an axial slot in the socket 46 in the form of an elongated rectangle with rounded corners, the width of which is dimensioned to allow play between the finger 106 and the edge of the groove in the circumferential direction. The groove 102 is open on the side facing the spherical hinge connection to allow the finger 106 to be introduced into the groove 102 in the assembled state. The length of the groove 102 and the length of the finger 106 are dimensioned so that the groove and the elongated projection remain at least partially engaged when the segment 26 and the connecting piece 24 are moved relative to each other, in particular when the segment 26 and the connecting piece 24 reach the maximum inclination angle α_max.

[0154] In the disclosed embodiment, three pairs of mutually engaged fingers and grooves are provided, and these fingers and grooves are arranged at equal circumferential spacing along a plane perpendicular to the longitudinal axis of the device (i.e., a plane perpendicular to the longitudinal axis of the segment in the case of the sphere, and a plane perpendicular to the longitudinal axis of the connecting member in the case of the ball socket).

[0155] Reference numerals list

[0156] Manipulable device 10

[0157] Elongated element 12

[0158] The distal end 14 of the steerable device

[0159] The distal end 16 of the elongated member

[0160] Device tip 20

[0161] Tubular portion 22

[0162] Connector 24

[0163] Segment 26

[0164] External cladding of elongated element 32

[0165] Magnetic components 34

[0166] Segment body 36

[0167] Distal segment interface and proximal segment interface 38a and 38b

[0168] Connector body 40

[0169] Distal connector interface and proximal connector interface 42a, 42b

[0170] Sphere 44

[0171] Ball socket 46

[0172] Socket wall 50

[0173] Ball socket outer surface 52

[0174] Inner surface of ball socket 54

[0175] Sphere wall 60

[0176] Sphere outer surface 62

[0177] The inner surface of the sphere is 64

[0178] Hole 65

[0179] Opening 66 of the socket

[0180] Insertion part 67

[0181] Segment interface collars 68a and 68b

[0182] Pipeline 69

[0183] Insertion portion 70 of the connector interface

[0184] Connector interface collars 72a and 72b

[0185] Gap 80

[0186] Granular materials 82

[0187] Through hole 84

[0188] Plug 86

[0189] Channel 88

[0190] Through hole 90

[0191] Pull 91

[0192] Casing 94

[0193] Braided sheath 96

[0194] Spring element 98

[0195] Pin 100

[0196] Groove 102

[0197] Finger 106

[0198] Device longitudinal axis L

[0199] Segment longitudinal axis Ls

[0200] Connector longitudinal axis Lc

Claims

1. A manipulable device (10) for use in a mammal, comprising: an elongated element (12) extending along a longitudinal axis (L) of the device, the elongated element (12) being configured to navigate in a mammalian body; The elongated element (12) has a flexible device tip (20) configured to allow manipulation of the elongated element (12) by an external magnetic field, The device tip (20) comprises a plurality of segments (26) and a plurality of connectors (24), each segment (26) comprising a segment body (36) and a segment interface (38a, 38b), the segment interface (38a, 38b) being arranged at each longitudinal end of the segment body, each connector (24) comprising a connector body (40) and a connector interface (42a, 42b), the connector interface (42a, 42b) being arranged at each longitudinal end of the connector body, the plurality of segments (26) and the plurality of connectors (24) being arranged along the device longitudinal axis (L), each connector (24) connecting two consecutive segments (26) in a manner allowing the segments and the connectors to move relative to each other in an assembled state, so as to allow bending of the device tip (20); Features Each pair of the connector interfaces (42a, 42b) and the segment interfaces (38a, 38b) have complementary shapes to allow rotational movement relative to each other and form a connection, thereby keeping the connector and the segment aligned along the longitudinal axis of the device in a mated state, and the magnetic element (34) at least partially forms the segment body or the connector body or both.

2. The manipulable device (10) according to claim 1, characterized in that The magnetic element (34) at least partially surrounds the segment body (36) or the connector body (40) or both, or the magnetic element (34) is at least partially embedded in the segment body or the connector body or both.

3. The manipulable device (10) according to claim 1 or 2, characterized in that The connector (24) is composed of a separate component in the form of a connector body (40) which is preferably formed as a tubular element and a separate component in the form of a connector interface (42a, 42b), wherein the connector interface (42a, 42b) is inserted into the connector body at each end of the connector body, and / or the segment (26) is composed of a separate component in the form of a segment body (36) which is preferably formed as another tubular element and a separate component in the form of a segment interface (38a, 38b), wherein the segment interface (38a, 38b) is inserted into the segment body at each end of the segment body.

4. The manipulable device (10) according to claim 3, characterized in that The tubular element or the further tubular element or both form the magnetic element (34).

5. The maneuverable device (10) according to any one of claims 1 to 4, characterized in that The tip of the device includes a first group (35) of segments and connectors preferably arranged at the distal end, the segments and connectors of the first group having a first length, and a second group (37) of segments and connectors preferably arranged at the proximal end, the segments and connectors of the second group having a second length, the first length and the second length being measured along the longitudinal axis of the device, the first length being smaller than the second length.

6. The manipulable device (10) according to any one of claims 1 to 4, characterized in that The tip of the device comprises a first group (35) of segments and connectors preferably arranged at the distal end, the segments and connectors of the first group having magnetic elements (34), and a second group (37) of segments and connectors preferably arranged at the proximal end, the segments and connectors of the second group not having magnetic elements.

7. The maneuverable device (10) according to any one of claims 1 to 4, characterized in that The device tip (20) includes segments having different lengths and connectors having different lengths.

8. The maneuverable device (10) according to any one of claims 1 to 7, characterized in that The connection is a spherical hinge connection, which includes a sphere (44) and a socket (46), wherein the socket (46) is arranged to connect the segment interface (38a, 38b) to the adjacent connector interface (42a, 42b) along the direction of the longitudinal axis (L) of the device, the socket (46) has a socket inner surface (54) and a socket outer surface (52), and the sphere (44) has a sphere outer surface (62). When the end of the device is bent, an inclination angle α is formed between the segment longitudinal axis (Ls) of the segment and the connector longitudinal axis (Lc) of the connector adjacent to the segment, and the spherical hinge connection forms multiple spherical hinge connections.

9. The manipulable device (10) according to claim 8, characterized in that The ball (44) of the spherical hinge connection is located on an axially extending neck, and for the segment (26) and the connecting member (24) of the spherical hinge connection, the inclination angle α is limited to a maximum inclination angle α_max, which is the maximum inclination angle α_max reached when the neck is in contact with the edge of the ball socket of the spherical hinge connection due to the relative movement of the segment relative to the connecting member, and the edge serves as a stop for the inclination of the segment relative to the connecting member.

10. The maneuverable device (10) according to claim 8, characterized in that The ball (44) of the spherical hinge connection is truncated by a first plane on the side of the ball facing the socket, the first plane is preferably parallel to the equatorial plane of the sphere, thereby forming a ball abutment surface, and the ball sockets (46) of the multiple spherical hinge connections have a flat socket bottom on the side facing the sphere, the flat socket bottom is preferably parallel to the equatorial plane of the socket, and for each spherical hinge connection segment (26) and connector (24) in the multiple spherical hinge connections, the inclination angle α is limited to a maximum inclination angle α_max, the maximum inclination angle α_max is the maximum inclination angle α_max reached when the ball abutment surface is in a contact position with the ball socket bottom due to the relative movement of the segment relative to the connector of the spherical hinge connection, the contact position serves as a stop for the inclination of the segment (26) relative to the connector (24).

11. The maneuverable device (10) according to any one of claims 8 to 10, characterized in that The outer surface (52) of the socket has a structured area, and the gap (80) formed between the socket (46) and the sheath of the manipulable device in the assembled state is filled with a granular material, the sheath at least surrounding the multiple segments (26) and the multiple connectors (24), wherein when the gap (80) is in a vacuum, the granular material (82) locks the relative positions of the multiple segments and the multiple connectors, and the gap is connected to a device for applying a vacuum.

12. The maneuverable device (10) according to any one of claims 8 to 11, characterized in that Each segment (26) and each connector (24) has a hole (65) extending in the direction of the longitudinal axis (L) of the device, and the hole (65) forms a plurality of holes, which, in the assembled state, form a conduit (69) passing through the plurality of segments and the plurality of connectors.

13. The maneuverable device (10) according to claim 12, characterized in that The segments (26) and the connectors (24) each include at least three channels (88), and the at least three channels (88) are preferably arranged in a manner equidistant from each other in the corresponding holes (65) forming the pipe (69), and the at least three channels (88) each form a through hole (90), wherein in the assembled state, the through hole of the segment is aligned with the through hole of the connector, and the through hole (90) forms at least three guide portions passing through the multiple segments and the multiple connectors, and the at least three guide portions are designed to allow a pull wire (91) to pass through, wherein the pull wire (91) is fixed in the distal region of the tip (20) of the device, and the pull wire (91) is designed to be pulled proximally to lock the relative positions of the multiple segments and the multiple connectors.

14. The maneuverable device (10) according to claim 12, characterized in that A sleeve (94) is arranged in the pipe (69), and the sleeve (94) includes a braided sheath (96) and a spring element (98) surrounded by the braided sheath (96), wherein when the sleeve is in a relaxed state, the outer diameter of the sleeve is equal to or smaller than the inner diameter of the pipe, and the outer diameter of the spring element is equal to or smaller than the inner diameter of the braided sheath (96), and the sleeve (94) extends from a distal sleeve end fixed in the distal area of ​​the tip of the device to a proximal sleeve end, and the proximal sleeve end is designed to be pulled proximally to switch the sleeve (94) from a relaxed state to a stretched state, in which the relative positions of the multiple segments and the multiple connectors are locked.

15. The steerable device (10) according to any one of claims 12 to 14, characterized in that The ball socket (46) of the spherical hinge connection includes a through hole (84) extending in a direction having a radial component, the through hole (84) having an inward taper and formed in the area of ​​the ball socket, in which the ball socket inner surface (54) contacts the ball outer surface (62) of the ball in the assembled state, and in which the ball socket includes a plug (86) designed to be introduced into the through hole (84) to form a protrusion protruding from the ball socket inner surface (54) and contacting the ball outer surface (62), thereby increasing the friction between the ball and the ball socket when the pipe (64) is in a vacuum to lock the relative positions of the multiple segments and the multiple connecting parts.

16. A manipulable device (10) according to any one of claims 8 to 15, characterized in that The ball and the socket of the spherical hinge connection have a torque transmission device in the form of a radially outwardly protruding boss and a groove (102). In the assembled state, the boss is inserted into the groove (102), and the boss and the groove (102) are designed to allow torque to be transmitted between the ball (44) and the socket (46) in a mutually matching manner, wherein the ball (44) includes a radially outwardly protruding boss and the socket (46) includes a groove (102), or the ball includes a groove and the socket includes a radially inwardly protruding boss.

17. The maneuverable device (10) according to claim 16, characterized in that The boss is in the form of a radially protruding pin (100), and the groove (102) is in the form of an axial slit whose width is dimensioned to form a clearance between the pin (100) and the edge of the groove in the circumferential direction.

18. A maneuverable device (10) according to any one of claims 8 to 17, characterized in that The spherical articulation connection of the plurality of spherical articulation connections has a ball (44) and a socket (46), the outer surface (62) of the ball having a structured area and the inner surface (54) of the socket having another structured area to increase the friction between the ball and the socket.

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