Instrument for use with a bone anchoring device and system consisting of both

Abstract

This application relates to an instrument for use with a bone anchoring device (2), the bone anchoring device (2) including a bone anchoring element (4) and a receiving part (5) for engaging a rod (3) with the bone anchoring element (4). The instrument (1, 1', 1'', 1000) includes: at least one tube (10, 30, 40, 1030) which is attachable to the bone anchoring device and defines a longitudinal axis (L); and at least one alignment element (20, 50) configured to assist in attaching the tube to the bone anchoring device. This application also relates to an instrument for locking and unlocking the head (13) of a bone anchor in the receiving part (5) of the bone anchoring device (2) and a system consisting of the instrument and the bone anchoring device.

Description

Technical Field

[0001] This invention relates to an instrument for use with a bone anchoring device, and also to a system comprising such an instrument and a bone anchoring device. In particular, the instrument may be an instrument for locking and unlocking the head of a bone anchor in a receiving part of the bone anchoring device, and / or the instrument may be an instrument for positioning and repositioning the receiving part of the bone anchoring device relative to the bone anchoring element. Background Technology

[0002] In spinal surgery, spinal rods and multiaxial bone anchors are often necessary to correct and / or stabilize multiple segments of the spine. During such procedures, repeated adjustments of the bone anchoring elements and rods relative to the receiving components of the corresponding multiaxial bone anchoring devices may be required.

[0003] Typically, a multi-axis bone anchoring device includes a coupling device and a bone anchoring element having a head that is pivotally received in the coupling device and can be locked at a desired angle relative to the coupling device. The coupling device also receives a rod configured to connect the multi-axis bone anchoring device to another bone anchor.

[0004] US 10470805B2 describes an apparatus suitable for performing such repetitive adjustments of a bone anchoring element relative to a rod. The apparatus includes a tube assembly comprising an inner tube and an outer tube, the tube assembly having a longitudinal axis, wherein the outer tube is movable relative to the inner tube from a first axial position to a second axial position and vice versa, the first axial position being associated with an unlocking configuration of the multi-axis bone anchoring device in which the head of the bone anchor is pivotable, and the second axial position being associated with a locking configuration of the multi-axis bone anchoring device in which the head is locked. The apparatus also includes an actuator assembly having an actuation mechanism for moving the inner tube relative to the outer tube, wherein the actuator assembly is rotatable about a longitudinal axis to a first rotational position and a second rotational position, in the first rotational position driving the tube assembly to take the first axial position, and in the second rotational position driving the tube assembly to take the second axial position.

[0005] It may be necessary to further simplify the operation of this device and / or use it in a wider range of applications. Summary of the Invention

[0006] The object of this invention is to provide an improved instrument for correcting, further positioning, or repositioning a multiaxial bone anchoring device relative to a rod during surgery. This instrument is simple for the user to operate and allows for a greater variety of correction steps during surgery. Another object of this invention is to provide such an instrument and a system comprising a multiaxial bone anchoring device suitable for use with it.

[0007] This objective is achieved by the apparatus according to claim 1, the apparatus according to claim 14, and the system according to claim 15. Further developments are given in the dependent claims.

[0008] According to an embodiment, the device is suitable for use with a bone anchoring device including a bone anchoring element and a receiving part for engaging a rod with the bone anchoring element. The device includes: at least one tube that can be attached to the receiving part of the bone anchoring device, the tube defining a longitudinal axis; and at least one alignment part configured to assist in attaching the tube to the receiving part.

[0009] According to another embodiment, an instrument for locking and unlocking the head of a bone anchor in a receiving portion of a bone anchoring device includes: a tube assembly attachable to the bone anchoring device, the tube assembly including at least a first tube and a second tube defining a longitudinal axis, the first tube and the second tube configured to engage the bone anchoring device and movable relative to each other between a first axial position associated with an unlocking configuration and a second axial position associated with a locking configuration, in which the head is unlocked in the receiving portion and in which the head is locked in the receiving portion; and at least one alignment member configured to assist in attaching the tube assembly to the bone anchoring device, wherein the instrument further includes an actuator assembly including an actuation mechanism configured to move the first tube and the second tube of the tube assembly from the first axial position to the second axial position and vice versa.

[0010] By guiding the tube or tube assembly relative to the receiving component of the bone anchoring device, the alignment component can help attach the tube or tube assembly to and / or detach it from the bone anchoring device.

[0011] In embodiments, the alignment member can be an external alignment member, such as an external sleeve, which at least partially surrounds the tube or the first and second tubes in its circumferential direction. The external alignment member can indicate a rotational position of the tube or tube assembly in which it engages the receiving member for connection to the receiving member, or in which it disengages from the receiving member for installation on and removal from the receiving member. Thus, installation of the tube or tube assembly onto the receiving member of the bone anchoring device can be convenient. Alternatively or additionally, the alignment member can be an internal alignment member, such as a plunger, which is at least partially disposed within the tube or within the first and second tubes of the tube assembly. Preferably, the internal alignment member is configured to press against a rod inserted into the receiving member. This facilitates installation of the tube or tube assembly onto the receiving member, particularly by bringing or holding the rod to its lowest position within the receiving member and / or providing additional guidance when positioning the tube assembly onto the receiving member.

[0012] According to another embodiment, an instrument for locking and unlocking the head of a bone anchor in a receiving portion of a bone anchoring device includes a tube assembly attachable to the bone anchoring device, the tube assembly including at least a first tube and a second tube defining a longitudinal axis, the first and second tubes configured to engage the bone anchoring device and movable relative to each other between a first axial position associated with an unlocking configuration and a second axial position associated with a locking configuration, in which the head is unlocked in the receiving portion and in which the head is locked in the receiving portion. The instrument further includes: an actuator assembly including an actuation mechanism configured to move the first and second tubes of the tube assembly from the first axial position to the second axial position and vice versa; the actuator assembly configured to take at least a third configuration in which the actuator assembly is connectable to and / or removable from the tube assembly; and a fixation mechanism preventing the actuator assembly from taking the third configuration. Preferably, the fixation mechanism is configured such that it can be released by loosening a handle portion of the actuator assembly.

[0013] Fixation mechanisms improve instrument handling and enhance its safety during surgery, particularly by preventing accidental release of the actuator assembly from the tubular assembly.

[0014] On another front, the actuator assembly can be removably connected to the tube assembly, thus enabling the adjustment of multiple bone anchoring devices, particularly multiaxial bone anchoring devices, each connected one after another to the tube assembly via a single actuator assembly. Since the tube assemblies can be positioned close to each other, operation using a single actuator assembly is convenient, considering the reduced available space. The tube assemblies can be all the same or different in their length or other characteristics (e.g., engagement features for engagement with the (multiaxial) bone anchoring devices). Therefore, the device can also provide a modular system comprising the actuator assembly and different tube assemblies suitable for use with the actuator assembly.

[0015] Furthermore, the device according to the embodiment provides a sensor component and / or a navigation component configured to detect at least one of the unlocking and locking configurations of the head in the receiving component, or a first axial position and a second axial position of the first and second tubes. The device or sensor component may additionally generate signals, particularly optical and / or auditory signals, when it enters one of the different locking, unlocking, or removal configurations. This further enhances security and user-friendliness.

[0016] The sensor component and / or navigation component may include a base component connectable to the instrument and a movable element, such as a sensor element or pin, movable relative to the base component. The sensor component and / or navigation component may be configured such that movement of the first and second tubes of the tube assembly relative to each other between a first axial position and a second axial position (or vice versa) causes movement of the movable element relative to the base component. The movement of the movable element may be detected by a sensor device, wherein the sensor device may be specifically configured to measure the distance of the sensor element relative to a reference position, and / or the displacement of the sensor element, and / or the pressure acting on the sensor element, and / or may be a position sensor configured to detect the position of the sensor element. Alternatively or additionally, the movable element may be provided with a navigation ball, and the navigation component may be configured to detect the relative or absolute displacement of the navigation ball.

[0017] Furthermore, this device simplifies the calibration steps required for adjusting the bone anchoring element and rod, as well as for adjusting the position of one or more vertebrae. Temporary locking of the bone anchoring element in the receiving component can be achieved using only the device with the rod already inserted into the receiving component, without the need for locking elements (such as fixing screws). As a result, the multi-axis bone anchoring device allows for multiple adjustments or readjustments of the angular position of the receiving component relative to the bone anchoring device while the rod is already inserted. Using the device to temporarily lock the head also allows the multi-axis bone anchoring device to be used in the same way as a uniaxial bone anchoring device. Attached Figure Description

[0018] Other features and advantages of the invention will become clear from the description of the embodiments using the accompanying drawings. In the drawings:

[0019] Figure 1 A perspective view of the device and bone anchoring apparatus according to an embodiment is shown.

[0020] Figure 2 It indicates Figure 1 An exploded perspective view of the tubular components of the instrument.

[0021] Figure 3 It indicates Figure 2 A perspective view of the tube assembly in its assembled state.

[0022] Figure 4 It indicates Figure 2 and 3 A perspective view of the outer tube of the tube assembly.

[0023] Figure 5 It indicates Figure 2 and Figure 3 A perspective view of the internal tubes of the tube assembly.

[0024] Figure 6a It indicates Figure 3The upper part of the tube assembly is in an enlarged perspective view of the first structure.

[0025] Figure 6b It indicates Figure 3 The upper part of the tube assembly is in an enlarged perspective view of the second construction.

[0026] Figure 7 It indicates Figure 2 and 3 Exploded perspective view of the plunger of the tube assembly.

[0027] Figure 8 It indicates Figure 7 A perspective view of the plunger in its assembled state.

[0028] Figure 9 It indicates Figure 2 and 3 First perspective view of the outer sleeve of the tube assembly.

[0029] Figure 10 It indicates Figure 2 , 3 Second perspective view of the outer sleeve of the tube assembly of 9.

[0030] Figure 11 It indicates Figure 3 A cross-sectional view of multiple parts of a pipe assembly, wherein the cross-section is taken along a plane including the longitudinal axis of the pipe assembly.

[0031] Figure 12 It indicates Figure 11 Enlarged sectional views of the upper and lower portions of the pipe assembly.

[0032] Figure 13 It indicates Figure 1 An exploded perspective view of the actuator components of the device.

[0033] Figure 14 It indicates Figure 13 A perspective view of the actuator assembly in its assembled state.

[0034] Figure 15 It indicates Figure 14 An enlarged view of a portion of the actuator assembly.

[0035] Figure 16 It indicates Figure 13 and 14 A perspective view of the second internal tube of the actuator assembly.

[0036] Figure 17 It indicates Figure 13 and 14 A perspective view of the first internal tube of the actuator assembly.

[0037] Figure 18a This indicates what it means when viewed from slightly above at a certain angle. Figure 13 and 14 A perspective view of the adjusting component of the actuator assembly.

[0038] Figure 18b This indicates what it means when viewed from a slightly lower angle. Figure 18a A perspective view of the adjustment components.

[0039] Figure 19 It indicates Figure 18a and 18b Top view of the adjustment components.

[0040] Figure 20 It indicates Figure 1 Exploded perspective view of the bone anchoring device.

[0041] Figure 21 It indicates Figure 20 A perspective view of the bone anchoring device in its assembled state.

[0042] Figure 22 It indicates Figure 21 An enlarged perspective view of a portion of the bone anchoring device.

[0043] Figures 23a to 23c It indicates Figure 1 instruments and Figure 21 A perspective view of the steps involved in connecting the bone anchoring device.

[0044] Figures 24a to 24c It indicates Figure 1 The lower part of the instrument and Figure 21 The upper part of the bone anchoring device is in Figures 23a to 23c Enlarged view of the steps.

[0045] Figure 25a and 25b It indicates Figure 1 The lower part of the instrument and Figure 21 A cross-sectional view of the upper portion of the bone anchoring device when the insertion head in the bone anchoring device is locked and unlocked, wherein the section is taken in a plane that extends through the central axis of the receiving component and is perpendicular to the axis of the insertion rod.

[0046] Figure 26 This shows a perspective view of the apparatus according to another embodiment.

[0047] Figure 27 It indicates Figure 26 A perspective view of the instrument in the assembled state of the sensor components.

[0048] Figure 28 It indicates Figure 26An enlarged perspective view of a portion of the instrument.

[0049] Figure 29 It indicates Figures 26 to 28 An enlarged perspective view of a portion of the instrument in the assembled state of the sensor component.

[0050] Figure 30 It indicates Figures 26 to 29 A perspective view of the outer surface of the sensor component of the device, wherein the sensor component is viewed slightly from above.

[0051] Figure 31 It indicates Figure 30 A perspective view of the inner surface of the sensor component, wherein the sensor component is viewed slightly from above.

[0052] Figure 32 It indicates Figure 30 A top view of the sensor component.

[0053] Figure 33 It indicates Figure 30 A side view of the outer surface of the sensor component.

[0054] Figure 34 It indicates Figure 30 A side view of the inner surface of the sensor component.

[0055] Figure 35a and 35b It indicates Figure 26 A sectional view of a portion of the device in the assembled state of the sensor component during the locking and unlocking of the insertion head in the bone anchoring device, wherein the section is taken in a plane extending through the longitudinal axis of the tube assembly.

[0056] Figure 36a and 36b This indicates the locking and unlocking of the head. Figure 30 A perspective view of the inner surface of the sensor component.

[0057] Figure 37 This shows a perspective view of the apparatus according to another embodiment.

[0058] Figure 38 This indicates when viewed from slightly below. Figure 37 A perspective view of the navigation components of the instrument.

[0059] Figure 39 It indicates Figure 38 A perspective side view of the navigation component.

[0060] Figure 40 It indicates Figure 38 A perspective rear view of the navigation component.

[0061] Figure 41 It indicates Figure 40 An enlarged perspective view of a portion of the navigation component.

[0062] Figure 42 The diagram shows a perspective view of the spine, which has multiple multi-axis bone anchors and is connected to a first multi-axis bone anchor. Figure 1 The device and the device according to another embodiment connected to the second multi-axis bone anchoring device.

[0063] Figure 43 It indicates that according to Figure 42 Another embodiment of the device is shown in a perspective view of the device in its assembled state.

[0064] Figure 44 It indicates Figure 43 A perspective view of the tube of the instrument.

[0065] Figure 45 It indicates Figure 43 A perspective view of the outer sleeve of the instrument. Detailed Implementation

[0066] Figure 1 An embodiment of a device 1 for use with a multi-axis bone anchoring device 2 is shown, the multi-axis bone anchoring device 2 being configured to connect a rod 3 to a bone anchoring element 4. The device 1 includes a tube assembly 10 and an actuator assembly 100, the actuator assembly 100 being removably connected to the tube assembly 10. Figure 1 As shown, the tube assembly 10 can be attached to the multi-axis bone anchoring device 2.

[0067] The following will be referred to separately. Figures 2 to 12Tube assembly 10 is described. Tube assembly 10 includes an outer sleeve 20, an outer tube 30, an inner tube 40, and a plunger 50. The inner tube 40 may be a first tube, and the outer tube 30 may be a second tube. The outer tube 30 and the inner tube 40 define a longitudinal axis or tube axis L. In the assembled state of tube assembly 10, the outer sleeve 20 completely surrounds the lower portion of the outer tube 30 in the circumferential direction, the inner tube 40 is disposed within the outer tube 30, and the plunger 50 is disposed within the inner tube 40. The outer sleeve 20 may rotate relative to the outer tube 30 about the longitudinal axis L to a certain extent allowing tube assembly 10 to engage with multi-axis bone anchoring device 2. Moreover, in the assembled state of tube assembly 10, the plunger 50 is configured to enter at least a portion of the multi-axis bone anchoring device 2 and press against the rod 3 from above when the rod 3 is present in the bone anchoring device 2. Furthermore, in the assembled state of the tube assembly 10, the outer tube 30 and the inner tube 40 can be axially moved relative to each other along the longitudinal axis L to a certain extent, which allows a portion of the multi-axis bone anchoring device 2 to move from the unlocked position of the bone anchoring element 4 to the locked position of the bone anchoring element 4, and vice versa. The axial displacement of the inner tube 30 and the outer tube 40 relative to each other is achieved by the actuator assembly 100, as explained in more detail below.

[0068] like Figure 2 , 4 As shown in more detail in 11 and 12, the outer tube 30 includes a front end 30a and a rear end 30b opposite to the front end 30a. The outer tube 30 includes an internal channel extending between the front end 30a and the rear end 30b and configured to receive the inner tube 40 therein. The anterior portion of the outer tube 30 adjacent to the front end 30a may taper gradually toward the front end 30a in portion 31 on the outer surface of the outer tube in order to reduce the total space required for the device to be attached to the multiaxial bone anchoring device 2.

[0069] The notch 32 is formed to extend from the front end 30a of the outer tube 30 to a certain distance. The width of the notch 32 in the circumferential direction is greater than the upper width of the multi-axis bone anchoring device 2, and the height in the axial direction is allowed to be as follows. Figure 1 The rod 3 shown extends through the notch 32 and can move axially within the notch 32. For example... Figure 12 As shown in the optimal configuration, a connecting structure 34 is provided at a certain distance from the front end 30a of the outer tube 30. This connecting structure is used to connect with a corresponding connecting structure of the multi-axis bone anchoring device 2. The connecting structure 34 may be in the form of a circumferentially extending rib formed on the inner surface of the outer tube, which engages with a corresponding groove on the multi-axis bone anchoring device 2. At a certain distance from the connecting structure 34 toward the rear end 30b of the outer tube, a stepped portion or a circumferentially extending shoulder 35 is provided on the inner surface of the outer tube. This stepped portion or circumferentially extending shoulder 35 forms an abutment for the inner tube 40.

[0070] like Figure 4 and 6a As best shown in 6b, adjacent to the rear end 30b of the outer tube 30, a notch or recess 37 is formed on each side of the longitudinal axis L. The recess 37 opens toward the rear end 30b and extends a certain distance from the rear end 30b. In the perspective view, as... Figure 6a and 6b As shown, each notch 37 has a generally stepped shape, thus forming a first notch region 37a and a second notch region 37b. The first notch region 37a opens toward the rear end 30b and is adjacent to the rear end 30b in the circumferential direction. The second notch region 37b may have a smaller width in the circumferential direction and extends further downward (i.e., toward the front end 30a) from a certain distance from the rear end 30b compared to the first notch region 37a. The notches 37 function to accommodate the driving portion of the actuator assembly and the driven portion from the internal tube 40. The orientation of the notches 37 is such that the notches 37 are substantially aligned in the circumferential direction with the engagement structure 34 at the front end 30a.

[0071] The corner formed between the first notch region 37a and the second notch region 37b can be rounded or slanted, such as... Figure 6a , 6b As shown.

[0072] At a distance from the rear end 30b, a protrusion 38 is formed on the outer surface of the outer tube 30 for engaging with the elongated slot of the actuator assembly 100. The protrusion 38 is located at a circumferential position substantially aligned with the notch 37 at the rear end 30b and the engagement structure 34 at the front end 30a.

[0073] At a certain axial distance from the protrusion 38 and further towards the front end 30a, an attachment feature is provided in the outer tube 30. This attachment feature takes the form of a circumferentially extending groove 39 and a notch 39a. The circumferentially extending groove 39 is provided in the outer surface of the outer tube 30 and is used to receive the clamping member 60 therein, such as... Figure 2 and 3 As shown. The circumferentially extending groove 39 may extend along the entire circumference of the outer tube, or only along a portion of the outer tube corresponding to at least the circumferential extension of the clamping member 60. More specifically, the notch 39a is formed as a through hole extending through the entire wall of the outer tube 30. The notch 39a is used to receive a pin 61 disposed on the inner surface of the clamping member 60, the length of which exceeds the thickness of the outer tube 30 and the inner tube 40, so that it can engage the plunger 50 in the assembled state of the tube assembly 10. The notch 39a is located at a circumferential position in the groove 39, slightly offset from the center of the notch 32 at the front end 30a.

[0074] At a certain axial distance from the groove 39 and towards the front end 30a of the outer tube 30, two recesses 139a and 139b are optionally provided in the wall of the outer tube 30. The recesses 139a and 139b are circumferentially positioned on opposite sides of the outer tube, i.e., spaced approximately 180° apart, and each recess may be located at a circumferential position offset approximately 90° from recess 39a. The recesses 139a and 139b extend through the entire wall of the outer tube and may be used to attach additional navigation and / or sensor elements to the tube assembly, or to provide an inlet to the inner tube 40. When viewed in a plane of the outer surface of the outer tube, each recess 139a and 139b may have a generally elongated or elliptical profile, wherein the longer axis of the profile extends circumferentially along the outer tube 30.

[0075] A mark 71 may be provided at a certain axial distance from the groove 39 and / or the notches 139a, 139b and further towards the front end 30a of the outer tube 30. This mark 71 indicates the rotational position of the outer sleeve 20 relative to the outer tube 30. The mark 71 may be an elongated strip or a straight line extending along the axial direction of the outer tube 30. The mark 71 may be located at a circumferential position substantially aligned with the notch 39a of the attachment feature.

[0076] At a certain axial distance from mark 71 and towards the front end 30a of the outer tube 30, two engagement features in the form of notches 36 are provided in the outer surface of the outer tube 30; only one notch 36 is visible in the figure. The notches 36 are spaced apart in the circumferential direction of the outer tube and are used to receive corresponding engagement features of the outer sleeve 20 in the corresponding rotational positions of the outer sleeve 20, such as engagement locks, as explained in more detail below.

[0077] Refer to the following again Figure 2 And refer to other sources Figure 5 , 11 12, the inner tube 40 includes a front end 40a and a rear end 40b, as well as an internal channel that extends from the front end 40a at least along a portion of the inner tube toward the rear end 40b and is configured to receive a plunger 50 therein. The inner diameter of the inner tube 40 (i.e., the diameter of its internal channel) allows a fixing element, such as a fixing screw or other instrument, to pass through.

[0078] A notch 42 is formed in the front portion adjacent to the front end 40a of the inner tube 40. This notch 42 substantially corresponds to the notch 32 of the outer tube 30, such that when the inner tube 40 is inside the outer tube 30, the notches 32 and 42 are aligned (see example). Figure 3A connecting structure 44 is provided at a certain distance from the front end 40a. This connecting structure 44 is configured to mate with a corresponding connecting structure at the multi-axis bone anchoring device 2. In the illustrated embodiment, the connecting structure 44 is a circumferentially extending groove provided in the inner surface of the inner tube 40, which can mate with a circumferentially extending rib at the multi-axis bone anchoring device 2.

[0079] In the upper region 43a adjacent to the rear end 40b of the inner tube 40, first protrusions 45a, 45b are formed on the outer surface of the inner tube 40. These first protrusions serve as driven portions driven by the driving portion of the actuator assembly 100, causing the inner tube 40 to move relative to the outer tube 30. Two sets of first protrusions 45a, 45b are disposed on opposite sides of the inner tube 40 in the circumferential direction relative to the longitudinal axis L. Figure 2 , 5 As shown in 6a and 6b, one protrusion 45a is located at a first distance from the rear end 40b, and another protrusion 45b is located at a second distance from the rear end 40b, the second distance being greater than the first distance, and the other protrusion 45b is circumferentially offset from and adjacent to protrusion 45a. Protrusions 45a and 45b may have an approximately square profile, optionally with sloping edges, and may have a radial height such that when the inner tube 40 and the outer tube 30 are assembled, protrusions 45a and 45b are substantially flush with the outer cylindrical surface of the outer tube 30. For this purpose, the inner tube 40 may have a reduced outer diameter in the upper region 43a, including the first protrusions 45a and 45b, compared to the inner tube's outer diameter in the lower region 43b of the inner tube. Figure 6a and 6b As shown in more detail, in the assembled state, the protrusion 45a closer to the rear end 40a of the inner tube 40 is located in the first recess region 37a of the recess 37 of the outer tube 30, and the second protrusion 45b is located in the lowermost portion of the second recess region 37b of the recess 37 of the outer tube 30. The circumferential distance between the protrusions 45a and 45b is such that, in the assembled state, there is a gap G between the first protrusion 45a and the opposite sidewalls of the recess 37, which allows the drive portion of the actuator assembly to enter the recess 37. The inner tube 40 can be assembled with the outer tube 30 by first introducing the lower protrusion 45b into the recess 37, rotating the inner tube 40 relative to the outer tube 30, and then allowing the upper protrusion 45a to enter the recess 37.

[0080] A notch 49 is provided at a certain axial distance from the upper region 43a of the inner tube 40 and further toward the front end 40a. The notch 49 is formed as a through hole extending through the entire wall of the inner tube 40 and is used to receive the pin 61 of the clamping member 60. Moreover, in the assembled state of the tube assembly, the notch 49 is located at an axial and circumferential position of the inner tube, which corresponds to the axial and circumferential position of the notch 39a of the outer tube 30. More specifically, the notch 49 has an elongated shape (e.g., elliptical), wherein the long axis of the elongated shape extends along the axial direction of the inner tube 40, so that even when the pin 61 of the clamping member 60 extends from the clamping member 60 through the notch 39a of the outer tube and the notch 49 of the inner tube, the inner tube 40 and the outer tube 30 can move axially relative to each other in the direction of the longitudinal axis L.

[0081] Optionally, a notch 48 is provided at a certain axial distance from the notch 49 of the inner tube, extending through the entire wall of the inner tube 40. The wall region of the inner tube surrounding the notch 48 may be locally thinned such that the profile 48a of the notch 48 at the outer surface of the inner tube is larger than the profile of the notch 48 at its inner surface, and / or an inclined wall portion 48b is provided at the upper and / or lower ends of the notch 48 in the axial direction. The notch 48 may have a generally elongated or elliptical profile, the major axis of which extends in the axial direction of the inner tube 40 (i.e., in the direction of the longitudinal axis L). The notch 48 is located in an axial and circumferential position of the inner tube 40, which corresponds to the axial and circumferential position of the notch 139a or 139b of the outer tube 30 in the assembled state of the tube assembly. The inner tube 40 may be provided with two such notches 48, which are located on opposite sides of the inner tube in the circumferential direction.

[0082] Refer again Figure 2 And refer to other sources Figure 7 , 8 11 and 12, plunger 50 includes a front end 50a and a rear end 50b. The outer diameter of plunger 50 allows it to be received within the internal channel of the inner tube 40 of the tube assembly. The front region 51 of plunger 50, adjacent to the front end 50a, may have a reduced outer diameter such that, in the assembled state of the tube assembly, at least along a portion of the longitudinal axis L, a circumferentially extending gap is formed between the outer surface of the front region 51 of plunger 50 and the inner surface of the inner tube 40, as shown below. Figure 11 and 12 As shown. The size of the gap can be configured to accommodate a portion of the receiving component of the multi-axis bone anchoring device 2, allowing the front region 51 of the plunger 50 to enter the receiving component. In the rear region of the plunger 50, the plunger 50 can be provided with an outer cylindrical surface that contacts the inner surface of the inner tube when the inner tube and the plunger are assembled.

[0083] An elongated opening 52 is positioned axially between the rear end 50b and the front region 51 of the plunger 50, penetrating the plunger 50 in a direction perpendicular to the longitudinal axis L. The opening 52 extends between a first end 52a closer to the plunger front end 50a and a second end 52b closer to the plunger rear end 50b. The opening 52 is sized to accommodate an elastic element, such as a coil spring 53. An attachment feature is arranged between the second end 52b of the opening 52 and the coil spring 53, taking the form of a cylindrical attachment element 54 with a through-hole 54a. The through-hole 54a of the attachment element 54 accommodates a sleeve 55 with a through-hole 55a configured to receive a pin 61 of the clamping member 60 (see [link to relevant documentation]). Figure 2 , 3 ( ), so that the plunger 50 can be attached to the inner tube 40 and the outer tube 30.

[0084] In the assembly state of the tube assembly, such as Figure 3 , Figure 11 and Figure 12 As shown, the plunger 50 extends axially through its front end 50a into the recesses 32, 42 of the outer tube 30 and the inner tube 40, and preferably protrudes axially through its front end 50a beyond the outer tube 30 and / or the outer sleeve 20. When the tube assembly 10 is attached to the multi-axis bone anchoring device 2 while the rod 3 is present in the receiving component, as... Figure 1 As shown, due to the presence of rod 3, plunger 50 moves axially toward the rear end 40b of inner tube 40, which causes helical spring 53 to compress within elongated opening 52, and thus generates a reaction force acting on plunger 50 in a downward direction (i.e. toward the front end 40a of inner tube), thereby pressing rod 3 downward in receiving component.

[0085] Refer again Figure 2 and 3 and further reference Figures 9 to 12 The outer sleeve 20 includes a front end 20a, a rear end 20b, and an internal channel extending from the front end 20a to the rear end 20b. The inner diameter of the outer sleeve 20 (i.e., the internal channel) allows the front portion of the outer tube 30 to be received therein.

[0086] A notch 22 is formed in the front region adjacent to the front end 20a, extending a certain distance from the front end 20a of the outer sleeve 20. The notch 22 has a height in the axial direction that allows the rod 3 to extend through and move axially within the notch 22. Figure 1 The width of the notch 22 in the circumferential direction is substantially corresponding to or slightly greater than the diameter of the rod 3, and smaller than the widths of the notches 32 and 42 of the outer tube 30 and the inner tube 40, respectively.

[0087] The axial length of the outer sleeve 20 between the front end 20a and the rear end 20b can be shorter than the axial length of the inner tube 40 and the outer tube 30. The axial length of the outer sleeve 20 can be such that, when the outer sleeve 20 is assembled with the outer tube 30, the rear end 20b is substantially located in the area marked 71 of the outer tube 30.

[0088] A locking tab 23 is provided at a distance from the rear end 20b of the outer sleeve 20. This locking tab 23 is configured to selectively engage one of two recesses 36 located on the outer surface of the outer tube 30. The engagement of the locking tab 23 with the corresponding recess 36 of the outer tube 30 attaches the outer sleeve 20 to the outer tube 30 at a specific rotational position. Specifically, the engagement of the locking tab 23 with the first recess 36 determines a first rotational position of the outer sleeve relative to the outer tube, and the engagement of the locking tab 23 with the second recess 36 determines a second rotational position of the outer sleeve relative to the outer tube.

[0089] Markings 72a and 72b are disposed on the outer surface of the outer sleeve 20, adjacent to the rear end 20b, indicating the position and / or function of the tube assembly 10. Markings 72a and 72b are offset from each other circumferentially along the outer sleeve 20 such that when the locking tab 23 engages the first recess 36 of the outer tube 30 in the first rotational position, the first marking 72a of the outer sleeve 20 is circumferentially aligned with the marking 71 of the outer tube 30, and when the locking tab 23 engages the second recess 36 of the outer tube 30 in the second rotational position, the second marking 72b of the outer sleeve 20 is circumferentially aligned with the marking 71 of the outer tube 30. The first marking 72a can provide a function indication of "introduction," and the second marking 72b can provide a function indication of "operation."

[0090] As explained in more detail below, when the outer sleeve 20 is in the first rotational position indicated by the "Introduction" indicator (where the first mark 72a of the outer sleeve 20 is aligned with the mark 71 of the outer tube 30), the tube assembly can be positioned on and removed from the receiving part of the multiaxial bone anchoring device 2. In the second rotational position indicated by the "Operation" indicator, where the second mark 72b of the outer sleeve 20 is aligned with the mark 71 of the outer tube 30, the tube assembly engages with the receiving part of the multiaxial bone anchoring device 2 and cannot be removed from the receiving part.

[0091] The widths of notches 32 and 42 in the circumferential direction of the outer tube 30 and the inner tube 40 respectively exceed the width of notch 22 of the outer sleeve 20, such that in the “introduction” and “operation” positions of the outer sleeve 20 relative to the tubes 30 and 40, all notches 22, 32, and 42 of the outer sleeve 20 and the tubes 30 and 40 overlap in the circumferential direction to allow the rod to pass through.

[0092] The following will refer to Figures 13 to 19 The actuator assembly is described in more detail. The actuator assembly 100 includes a first inner sleeve 110, a second inner sleeve 120, an outer sleeve 130, an adjustment component 140, a handle portion 150, and an operating lever assembly 160 in the form of a toggle lever.

[0093] The outer sleeve 130 has a front end 130a and a rear end 130b. An internal thread 131 is provided at or near the rear end 130b, which allows the handle portion 150 to be connected to the outer sleeve 130.

[0094] A first hinge 132 is provided near the rear end 130b for attaching an operating lever arm of the operating lever assembly 160; more specifically, the first hinge 132 provides a rotation point for the toggle operating lever. Multiple elongated openings 133 are arranged circumferentially for easy cleaning. Additionally, an elongated slot 134 extends axially from the front end 130a at the same circumferential position as the first hinge 132, a distance away from the front end. The slot 134 allows a second hinge located at the first inner sleeve 110 and a protrusion 38 located at the outer tube 30 of the tube assembly 10 to protrude through it.

[0095] An opening or recess 135 is provided in the wall of the outer sleeve 130 at approximately 90° circumferentially from the first hinge 132, allowing the adjusting lever 141 of the adjusting member 140 to protrude through it. Figure 15 As shown in more detail, the opening 135 is located near the rear end 130b of the outer sleeve 130. In the perspective view, the opening 135 has a generally stepped shape, thereby forming a first opening region 135a and a second opening region 135b adjacent to it in the circumferential direction, wherein the first opening region 135a and the second opening region 135b have the same extension range in the axial direction, and the first opening region 135a is located at a smaller distance from the rear end 130b compared to the second opening region 135b.

[0096] The circumferential width of the second opening region 135b is configured to allow the adjustment lever 141 of the adjustment member 140, described below, to move to a certain extent along the circumferential direction of the outer sleeve. The distance between the rear end 130b of the outer sleeve 130 and the first opening region 135a is such that the adjustment lever 141 of the adjustment member 140 can only be received in the first opening region when the handle portion 150 moves away from the rear end 130b (e.g., unscrewed from the outer sleeve 130), in order to provide additional space for the adjustment lever 141 to move upward from the second opening region 135b into the first opening region 135a.

[0097] At a certain axial distance from the opening 135 and further towards the front end 130a of the outer sleeve, functional indicators for "remove," "lock," and "unlock" can be provided. For example, a mark may be provided at the "remove" indicator to indicate the removal position of the actuator assembly 100, and / or an arrow may be provided indicating the direction of rotation of the adjusting member 140 to achieve the locked and unlocked positions. The "remove" indicator is located axially below the first opening region 135a, while the "lock" and "unlock" indicators are located at different circumferential positions axially below the second opening region 135b of the outer sleeve 130.

[0098] The handle portion 150 includes a threaded protrusion 151 that mates with the internal thread 131 of the outer sleeve 130 to allow the handle portion 150 to be threadedly connected within the outer sleeve 130. The handle portion 150 may also include a gripping structure 152, such as a circumferential convex angle or ridge for easy gripping. Multiple through holes 153 may also be provided in the handle portion 150 for easy cleaning.

[0099] For further reference Figure 17 The first inner sleeve 110 includes a front end 110a and a rear end 110b, and has an axial length shorter than that of the outer sleeve 130 and an outer diameter smaller than that of the outer sleeve 130, so that the first inner sleeve 110 can be completely accommodated within the outer sleeve 130. Adjacent to the front end 110a and at the same circumferential position as the first hinge 132 of the outer sleeve 130, a second hinge 112 is disposed on the outer surface of the first inner sleeve 110. In the assembled state of the actuator assembly 100, the second hinge 112 protrudes outward from the first inner sleeve 110 through a slot 134 in the outer sleeve 130. The second hinge 112 serves as a second rotation point for the toggle operating lever.

[0100] Furthermore, the first inner sleeve 110 includes a locking feature in the form of a locking tab 115, which partially protrudes into the internal channel of the first inner sleeve 110 and is used to engage with the second inner sleeve 120.

[0101] exist Figure 16The second inner sleeve 120, shown in more detail, includes a front end 120a and a rear end 120b, and has an outer diameter smaller than the inner diameter of the first inner sleeve 110, so that the second inner sleeve 120 can be received within the first inner sleeve 110. Adjacent to the front end 120a, the second inner sleeve 120 includes a circumferentially extending protrusion 121 on its outer surface, which forms an abutment for the front end 110a of the first inner sleeve 110. In the front region 125a adjacent to the circumferentially extending protrusion 121, the outer diameter of the second inner sleeve is slightly reduced compared to the rear region 125b adjacent to the rear end 120b, thereby forming an abutment or shoulder 125c on its outer surface, which is configured to engage by a locking tab 115 of the first inner sleeve 110. The axial positions of the first and second inner sleeves are fixed relative to each other by the engagement of the shoulder 125c with the locking tab 115 and the front end 110a of the first inner sleeve 110 abutting against the circumferentially extending protrusion 121 of the second inner sleeve 120.

[0102] Adjacent to the rear end 120b, two internal protrusions 122 are formed on the inner surface of the second inner sleeve 120. The protrusions 122 are located on opposite sides of the longitudinal axis, i.e., offset 180° in the circumferential direction. The protrusions 122 form second protrusions compared to the first protrusion of the tube assembly 10. They may have a generally square profile and serve as drive portions for transmitting the actuating motion of the operating lever assembly 160 to the tube assembly 10, as explained in detail below. Furthermore, two recesses 123 are provided at the rear end 120b, wherein the recesses are offset 180° from each other in the circumferential direction and arranged at approximately 90° relative to the protrusions 122. Each recess 123 extends a certain distance from the rear end 120b and may have a generally square profile. The recesses 123 are used to receive an extension of the adjusting member 140 therein.

[0103] exist Figure 18a , 18b The adjusting member 140 is shown in more detail in Figure 19. The adjusting member 140 includes an annular ring 144, which is sized to be received within the outer sleeve 130. An adjusting lever 141 is provided on the outer surface of the annular ring 144, and is connected to the annular ring 144 via a protrusion 141a. The protrusion 141a is sized to allow it to protrude through an opening 135 to the outside of the outer sleeve 130 when the adjusting member 140 is received within the outer sleeve 130. Therefore, the adjusting lever 141 can be accessed from the outside of the outer sleeve for manual actuation by the user.

[0104] The adjusting member 140 includes two internal protrusions 142 on the inner surface of the annular ring 144, which are offset from each other by 180°. The internal protrusions 142 are similar to the internal protrusions 122 of the second inner sleeve 120, i.e., they have a generally square profile. The internal protrusions 142 protrude from the inner surface of the annular ring 144 so as to locally narrow its internal width.

[0105] Furthermore, two extensions 143 are disposed on the underside of the annular ring 144, protruding downwards away from the annular ring 144 in the assembled state of the actuator assembly 100, i.e., protruding toward the front end 130a of the outer sleeve 130. The extensions 143 are offset from each other by 180° in the circumferential direction of the annular ring 144 and are arranged at approximately 90° relative to the protrusion 142. The extensions 143 have a shape similar to the shape of the recess 123 of the second inner sleeve 120; that is, each extension 143 may have a substantially square profile, such that each extension 143 can be at least partially accommodated within the corresponding recess 123 of the second inner sleeve 120. The circumferential width of the extension 143 corresponds to the circumferential width of the recess. Therefore, when the adjusting lever 141 rotates circumferentially within the opening 135 of the outer sleeve 130, the adjusting component 140 rotates circumferentially together with the second inner sleeve 120, which engages with the adjusting component through the extension portion 143.

[0106] In the assembled state of actuator assembly 100, the extension 143 of adjusting member 140 engages the recess 123 of second inner sleeve 120 such that the inner protrusion 142 of adjusting member 140 is circumferentially aligned with the inner protrusion 122 of second inner sleeve 120. Similar to the inner protrusion 122 of second inner sleeve 120, the inner protrusion 142 of adjusting member 140 is a second protrusion compared to the first protrusions 45a, 45b of tube assembly 10, and also serves to be configured to transmit the actuating motion of actuator assembly 100 to the drive portion of tube assembly 10.

[0107] Refer again Figure 13 and 14The lever assembly 160 includes a first lever arm 162, which is hinged at one end to a second hinge 112 located at a first inner sleeve 110 via a pin 163. The longer end portion or gripping portion 162a of the first lever arm 162 may have a gripping structure on its side facing away from the sleeves 110, 120, 130 for easy manual actuation. A second lever arm 164 of the lever assembly 160 is hinged at one side to the first hinge 132 via a pin 165 and at its second end to the first lever arm 162 via a pin 166. This latter connection provides a third rotation point for the toggle lever. In the illustrated embodiment, the second lever arm 164 is shorter than the first lever arm 162. The first lever arm 162 has a slightly angled shape. More specifically, the length of the gripping portion 162a of the first control arm 162 is such that the height position of the first control arm substantially corresponds to the height position of the handle portion 150.

[0108] Furthermore, an elastic component in the form of a spring 168 is provided at the first operating lever arm 162. The spring 168 is supported at the first operating lever arm 162 by a pin 167, and abuts against another pin 169 provided at the first operating lever arm 162 via its first end portion, and against an outer sleeve 130 via its second end portion. Therefore, when the first operating lever arm 162 moves toward the handle portion 150 to a more vertical position, i.e., to the upright configuration of the operating lever assembly 160 (where the first operating lever arm 162 and the second operating lever arm 164 are more parallel or at a smaller angle (not shown)), the spring 168 generates a force that pushes the first operating lever arm 162 away from the handle portion 150 and returns it to its initial position. Figure 14 The force (shown) is applied to the lever assembly 160 in an angled configuration, wherein the first lever arm 162 and the second lever arm 164 are angled relative to each other, and the grip portion 162a extends angled away from the handle portion 150. This angled configuration is the default configuration of the lever assembly 160 due to the preload generated by the spring 168.

[0109] When the first operating lever arm 162 is pushed toward the handle portion 150, the operating lever assembly 160 adopts an upright configuration, wherein the first operating lever arm 162 and the second operating lever arm 164 are more parallel or at a smaller angle (not shown). This causes the first inner sleeve 110 to abut against the circumferentially extending protrusion 121 of the second inner sleeve 120, and the two inner sleeves 110, 120 are pushed downward toward the front end 130a of the outer sleeve 130. Therefore, the inner protrusion 122 of the second inner sleeve 120 moves axially away from the inner protrusion 142 of the adjusting member 140, so that the distance between the protrusion 122 of the second inner sleeve 120 and the protrusion 142 of the adjusting member 140 increases in the axial direction. The axial movement of the two protrusions 122 and 142 (which are the driving portions of the actuator assembly 100) relative to each other is transmitted to the protrusions 45a and 45b (i.e. the driven portions) of the tube assembly 10, so that the inner tube 40 of the tube assembly 10 moves relative to the outer tube 30, as described in more detail below.

[0110] The device is made of biocompatible materials. In particular, titanium or stainless steel can be such suitable materials, but other materials can also be used as long as they are biocompatible.

[0111] Refer to the following again Figures 1 to 3 Sections 6a, 6b and 13 to 15 will explain the installation of the tube assembly 10 and the actuator assembly 100, and the actuation of the tube assembly 10 by the actuator assembly 100.

[0112] The actuator assembly 100 is installed as follows. The plunger 50 is within the inner tube 40, which is within the outer tube 30, wherein the clamping member 60 is received within a circumferentially extending groove 39 such that its pin 61 extends through the inner and outer tubes into a through-hole 55a of the plunger 50 to retain the plunger 50 within the tubes. First protrusions 45a, 45b of the inner tube 40 are located in corresponding recessed regions 37a, 37b of the recess 37 of the outer tube 30.

[0113] Then, the outer sleeve 20 is mounted on the outer tube 30 by sliding the outer sleeve 20 onto the outer tube 30. In this first rotational position relative to the outer tube 30, the "introduction" indication of the first mark 72a of the outer sleeve 20 is circumferentially aligned with the mark 71 of the outer tube 30. The outer sleeve 20 slides onto the outer tube 30 until the locking tab 23 of the outer sleeve 20 engages the notch 36 of the outer tube 30.

[0114] The adjusting lever 141 of the actuator assembly 100 is in a circumferential position indicating the "removal" position, i.e., within the first opening region 135a of the opening in the outer sleeve 130, which can be achieved by loosening the handle portion 150 from the outer sleeve 130 to a certain extent. The actuator assembly 100 is mounted on the tube assembly 10 in such an orientation that the protrusion 38 on the outer surface of the outer tube 30 enters the elongated slot 134 of the outer sleeve 130 of the actuator assembly. In this orientation of the actuator assembly 100, the second protrusions 122, 142 of the actuator assembly, which are circumferentially aligned with each other, allow downward passage through the gap G of the tube assembly 10, which is formed between the first protrusion 45a of the inner tube 40 and the opposing sidewall of the recess 37 of the outer tube 30. Removal of the actuator assembly 100 from the tube assembly 10 is completed in the same position, wherein the second protrusions 122, 142 of the actuator assembly move upward through the gap G of the tube assembly.

[0115] The locking mechanism of device 1 is obtained as follows. First, the adjusting lever 141 of actuator assembly 100 is rotated counterclockwise and moved downward into the second opening region 135b of the opening of outer sleeve 130, with handle portion 150 fully threaded into outer sleeve 130 to prevent adjusting lever 140 from unintentionally reaching the "removed" position, in which it is received in first opening region 135a. When received in second opening region 135b, adjusting lever 141 can rotate circumferentially to selectively align with either a "locked" or "unlocked" indication. When adjusting lever 141 moves to the "locked" position, the second protrusions 122, 142 of actuator assembly 100 move into the first recess region 37a of tube assembly 10 located below the upper first protrusion 45a of inner tube 40. When the operating lever assembly 160 is actuated by pressing the first operating lever arm 162 toward the handle portion 150 to obtain an upright configuration (not shown), the second protrusions 122, 142 become spaced apart from each other, as described above, thereby creating or increasing the gap between them in the axial direction. When the lower wall of the recess 37 is provided with an abutment for the second protrusion 122 of the inner sleeve 120, the second protrusion 142 of the adjusting member 140 presses the first protrusion 45a of the inner tube 40 upward toward the rear end 30b of the outer tube 30, and the first protrusion 45b also moves upward relative to the outer tube. Figure 6b Therefore, the front ends 30a and 40a of the tubes move axially relative to each other, thereby increasing the distance between the joint structure of the inner and outer tubes.

[0116] The unlocking configuration is achieved by moving the adjusting lever 141 of the actuator assembly 100 to the "unlocked" position. The second protrusions 122 and 142 of the actuator assembly 100 enter the second recess region 37b of the tube assembly 10 above the lower first protrusion 45b. When the operating lever assembly 160 is actuated by pressing the first operating lever arm 162 toward the handle portion 150 to achieve an upright configuration (not shown), the second protrusions 122 and 142 become spaced apart, causing the second protrusion 122 of the inner sleeve 120 to push downwards the first protrusion 45b of the inner tube 40. The opposing (upper) walls of the recess 37 serve as abutments for the second protrusion 142 of the adjusting member 140. Figure 6a Therefore, the front ends 30a and 40a of the tube move axially relative to each other, making the distance between the joint structure of the inner tube and the outer tube smaller.

[0117] The following is for reference. Figures 20 to 22 The following will explain a multi-axis bone anchoring device 2 suitable for use with device 1. According to one embodiment, the multi-axis bone anchoring device 2 includes a bone anchoring element 4 having a shank 12 and a head 13 having a spherical outer surface portion. The bone anchoring element 4 may be a bone screw with a threaded shank. The head 13 may have a notch 14 configured for engagement with a tool, such as an actuator. A receiving member 5 is configured to receive the head 13, such that the bone anchoring element 4 is connected to the rod 3 via the head 13. Additionally, a fixing element 7, in the form of an internal screw or a retaining screw, may be provided for securing the rod 3 in the receiving member 5. Furthermore, the bone anchoring device 2 includes a locking ring 8 for locking the head 13 in the receiving member 5.

[0118] The receiving component 5 has a first end or upper end 5a and a second end or bottom end 5b. A rod receiving portion 90 is provided adjacent to the upper end 5a, and a head receiving portion 96 is provided adjacent to the lower end 5b. The rod receiving portion 90 is generally cylindrical and includes a coaxial hole 91 extending from the upper end 5a into the head receiving portion 96. The hole 91 includes internal threads in at least one region for receiving a fixing element 7. A generally U-shaped notch 92 forming a channel for receiving the rod 3 extends from the upper end 5a to almost the beginning of the head receiving portion 96. A groove or other weakening portion 93 may be provided at a distance from the upper end 5a, allowing the upper portion of the receiving component 5 formed by the U-shaped notch to be disconnected, which serves as an extending tab. Through the longer extending tab, a multi-axis bone anchoring device 2 with an insert rod 3 positioned higher than its final position can be manipulated, thus allowing, for example, a vertebra to be pulled against the rod.

[0119] A engagement structure for engaging with the tube assembly 10 is provided on the outer surface of the rod receiving portion 90. The engagement structure may include circumferentially extending ribs 94. The ribs 94 are arranged asymmetrically with respect to the plane comprising the central axis C of the receiving portion 5 and the channel axis of the basic U-shaped notch 92. This means that a first rib 94 begins at the U-shaped notch 92 on one side and extends around the receiving portion by a certain distance, and a second rib 94 begins on the opposite side of the U-shaped notch relative to the central axis C and extends around the receiving portion 5 from there by a certain distance. Therefore, a ribless surface 95 is formed from the U-shaped notch on each side.

[0120] The head receiving portion 96 has a basic cap-like shape and a hollow, basically spherical inner portion 97 (see...). Figure 25a , 25b The head receiving portion is pivotally received therein. Multiple slits 98 make the head receiving portion flexible, so that the head 13 can be clamped and eventually locked when pressure is applied to the head receiving portion through the locking ring 8.

[0121] The locking ring 8 is designed to surround the head receiving portion 96 and has an inner surface structure that allows the locking ring 8 to cooperate with the head receiving portion to achieve complete locking of the head 13 in the head receiving portion 96 when it is in its lowest position, and to achieve pre-locking when the locking ring 8 is in a position slightly above the lowest position. This still allows the head 13 to pivot in the head receiving portion, but prevents the head 13 from being removed from the head receiving portion 96.

[0122] The locking ring 8 also has multiple upright flexible portions 81 that can be engaged with the receiving component to initially hold the locking ring 8 in a pre-locked position. Additionally, two opposing protrusions 82 are provided on the upper side of the locking ring to support the rod 3. In the illustrated embodiment, the locking ring 8 also includes two upright arms 83 that are asymmetrical with respect to the plane extending through the central axis C and through the middle of the protrusions 82, in the same manner as the ribs 94 of the rod receiving portion 90. A groove-shaped engagement structure 84 is provided at the upper end of the arm 83, configured to engage with the tubular assembly 10 of the device 1. Figure 21 As shown in Figure 24, in the assembled state of the multi-axis bone anchoring device 2, the rib-shaped engagement structure on the receiving component 5 and the groove-shaped engagement structure on the locking ring 8 are circumferentially aligned, thereby exposing the ribless surface 95 of the head receiving portion 90. The upright arm 83 of the locking ring 8, which has the engagement structure 84 at or near the upper end, facilitates the location of the engagement structure by the instrument.

[0123] The use of the instrument will be explained below. Further references Figures 23a to 24cFirst, the steps for attaching the device 1 to the multi-axis bone anchoring device 2 will be explained. The bone anchoring element 4 can be implanted in the vertebra or other bones. The locking ring 8 is in an axial position relative to the receiving part 5, in which it does not completely lock the head, but rather prevents the head 13 from being removed from the head receiving part 96. The rod 3 is inserted into the basic U-shaped notch 92. Due to the extending tab, the rod 3 is still movable not only along the rod axis but also in the axial direction.

[0124] The tube assembly 10 of device 1 is in a first rotational position of the outer sleeve 20 relative to the outer tube 30, indicated by the "introduction" indicator. In this first rotational position, the first mark 72a of the outer sleeve 20 is aligned with the mark 71 of the outer tube 30, as shown below. Figure 23a and 24a As shown. Furthermore, the joint structure 34 of the outer tube 30 and the joint structure 44 of the inner tube 40 have a minimum distance from each other, which is determined by the front portion 40a of the inner tube 40 abutting against the inner shoulder portion 35 of the outer tube 30 (see...). Figure 12 In this configuration, the instrument 1 is positioned on the receiving part 5 of the bone anchoring device 2 and moves downward in such an orientation that the notch 22 of the outer sleeve 20 aligns with the basic U-shaped notch 92 of the receiving part 5, which forms a channel for the rod 3. This allows the instrument 1 to be positioned on the receiving part 5 with the rod 3 received therein. In this orientation of the instrument 1, the engagement structures 34 and 44 of the outer tube 30 and the inner tube 40 are circumferentially aligned with the unribbed outer surface portion 95 of the receiving part 5. The outer sleeve 20 with the notch 22 helps to position the instrument 1 correctly on the receiving part. Moreover, the plunger 50 of the tube assembly enters the coaxial hole 91 of the receiving part, which also helps to position the instrument on the receiving part and push the inserted rod 3 downward into the U-shaped notch 92. Therefore, both the outer sleeve 20 and the plunger 50 can be used as alignment components to help attach the tube assembly 10 to the bone anchoring device 2. This facilitates the operation of the instrument because it can be positioned on the receiving component, with the notch 22 of the outer sleeve 20 aligned with the rod already inserted into the receiving component. Therefore, the notch 22 provides the user with an indication of the correct installation position.

[0125] Next, as Figure 23b , 24b As shown, the engagement structures 34 and 44 of the tube assembly 20 of the instrument move along the unribbed surface portion 95 of the receiving member 5 to a position where the engagement structure in the form of the rib 34 of the outer tube 30 and the groove 44 of the inner tube 40 is in the same axial position as the corresponding engagement structure in the form of the groove 84 of the locking ring 8 and the rib 94 of the receiving member 5.

[0126] like Figure 23c , 24cAs shown, the device 1 is then rotated to take a second rotational position of the outer sleeve 20 relative to the outer tube 30, indicated by the "operation" indicator, in which the second mark 72b of the outer sleeve 20 is aligned with the mark 71 of the outer tube 30. In this position, the notches 32, 42 of the outer tube 30 and / or the inner tube 40 can abut against the inserted rod 3 using their circumferential edges. This causes the outer tube 30 and the inner tube 40 of the tube assembly 10 to rotate relative to the receiving member within the outer sleeve 20, so that the engagement structure at the device 1 and the engagement structures at the locking ring 8 and the receiving member 5 engage. More specifically, the rib 34 at the outer tube 30 engages the groove 84 at the locking ring 8, and the rib 94 at the receiving member 5 engages the groove 44 at the inner tube 40. To disengage the tube assembly 10, rotate the outer tube 30 back to the "introduced" position of the outer sleeve 20 so that the engagement structures 34, 44 of the tubes 30, 40 can be removed along the unribbed portion 95 of the receiving member 5.

[0127] The following is for reference. Figure 25a and 25b This explains the function of locking and unlocking the head 13 in the head receiving portion 96 of the receiving component 5 using device 1. Figure 25a In the middle, device 1 is in Figure 23c , 24c The engagement configuration of the device 100 is such that the engagement structure 34 of the outer tube 30 engages with the engagement structure 84 of the locking ring 8, and the engagement structure 44 of the inner tube 40 engages with the engagement structure 94 of the receiving component 5. The locking ring 8 is in the upper position along the axial direction, wherein the head 13 can still pivot in the head receiving portion 96, but is prevented from being removed from the head receiving portion 96. The front ends 40a, 30a of the inner tube 40 and the outer tube 30 of the tube assembly 10 have a minimum distance from each other. The plunger 50 is pressed against the rod, which is received in the U-shaped notch 92 of the receiving component 5. The actuator assembly 100 is in the "unlocked" configuration. In this configuration, the angle adjustment of the receiving component 5 and the locking ring 8 relative to the bone anchoring element 4 can be performed using the device 1.

[0128] Figure 25b This indicates the locked position of the locking ring 8 relative to the receiving part 5. In the locked position, the locking ring 8 moves downward compared to the unlocked position, so that it fully clamps and locks the head 13 in the head receiving part 96. This is achieved by using the external tube 30 to move the locking ring 8 downward, which is driven downward by the actuator assembly 100 when the actuator assembly 100 is actuated in the "locked" configuration. Figure 25b As shown, the distance between the receiving component 5 and the engaging structure of the locking ring 8 is increased. The front end 40a of the inner tube 40 no longer abuts against the inner shoulder 35 of the outer tube 30. In the locking mechanism, the associated vertebra or bone can be pulled upward toward the inserted rod 3 using the instrument 1.

[0129] When the device 1 is engaged with the bone anchoring device 2, repeated locking and unlocking of the head 13 can be performed. To achieve the locking configuration, the adjusting lever 141 of the actuator assembly 100 is rotated circumferentially within the second opening region 135b of the outer sleeve 130 so that it is aligned with the "locked" indicator. Pushing the first operating lever arm 162 toward the handle portion 150 achieves locking of the head 13, as... Figure 25b As shown. To release the locking mechanism, the first operating lever arm 162 of the actuator assembly 100 no longer rests against the handle portion 150, and therefore returns to its original position by the restoring force generated by the spring 168. Figure 14 The default configuration is shown. Then, the adjusting lever 141 of the actuator assembly 100 can be rotated circumferentially within the second opening region 135b so that it aligns with the "unlock" indication. Pushing the first operating lever arm 162 toward the handle portion 150 unlocks the head 13, as shown. Figure 25a As shown.

[0130] Finally, the device 1 can be removed from the bone anchoring device 2, and the fixing element 7 can be tightened to secure the locking structure (not shown in the figure). The removal of the device 1 can be achieved by rotating the outer tube 30 back to the "introduced" position of the outer sleeve 20, so that the joint structures 34, 44 of the tubes 30, 40 can be removed along the unribbed portion 95 of the receiving member 5.

[0131] Furthermore, during the use of the device, the multiple bone anchoring devices 2 described above can be implanted into the corresponding vertebrae (not shown in the figure). The rod 3 can be inserted into the receiving part 5 of the bone anchoring device, and the corresponding tube assembly 10 can be connected to the bone anchoring device. Multiple steps of positioning and repositioning of the receiving part can be performed using a single actuator assembly 100, which can be selectively connected to different tube assemblies 10. Because the actuator assembly 100 is easy to operate, the time spent on adjustment steps can be shortened when multiple bone anchoring devices must be adjusted. The space required for the device can be reduced. Moreover, the actuator assembly can be removed for easy cleaning of the device.

[0132] The following will refer to Figures 26 to 35b Another embodiment of the device is described. The device 1' according to this other embodiment is similar to the device 1 of the first embodiment, and additionally includes a sensor component 200. Components and elements of the device 1' that are identical or similar to those of the device 1 of the first embodiment described above are provided with the same reference numerals, and their descriptions are omitted.

[0133] The sensor component 200 of device 1' is a separate component that can be attached to the tube assembly 10 of device 1'. More specifically, the sensor component 200 can be mounted on the outer surface of the outer tube 30 at a position below the clamping member 60 by engaging with the notch 139a of the outer tube 30 and the corresponding notch 48 of the inner tube 40, such as... Figure 28 and 29 As shown.

[0134] Sensor component 200 in Figures 30 to 34 The following is a more detailed description. The sensor component 200 includes a base component 210, which generally has the shape of a portion of a ring and extends between a first end 200a and a second end 200b. The circumferential extension of the base component 210 between the first and second ends may exceed half the circumferential extension of the outer tube 30 at its outer surface. The inner surface of the base component 210 is substantially shaped to complement the outer surface of the outer tube 30; for example, it may be a cylindrical surface portion such that the inner surface of the base component 210 can contact the outer surface of the outer tube in the assembled state of the sensor component 200 and the tube assembly 10. An opening region is provided between the first end 200a and the second end 200b, which allows the sensor component 200 to be mounted on the outer tube. Due to the open shape of the base component 210, which is elastic, the first end 200a and the second end 200b can unfold when mounted on the outer tube 30, and can snap back to their initial positions when mounted on the outer tube 30, providing a force to hold the base component 210 on the outer tube. The base component 210 may include thickened end portions, such as protrusions, at its first end 200a and second end 200b, extending radially away from the outer surface of the base component 210.

[0135] The base component 210 extends axially from the lower boundary 201a to the upper boundary 201b, wherein the axial dimension of the base component 210 between the lower boundary 201a and the upper boundary 201b exceeds the axial dimension of the notch 139a of the outer tube 30 (see...). Figure 28 ).

[0136] A protrusion 202 is formed on the inner surface of the base member 210, preferably in the intermediate portion between the first end 200a and the second end 200b. The protrusion 202 is shaped and sized to be received within the recesses 139a or 139b of the outer tube. The protrusion 202 is defined by a peripheral edge 203 extending away from the inner surface of the base member 210, the peripheral edge 203 having a profile corresponding to the profile of the recesses 139a, 139b of the outer tube 30, for example, it may have a generally elongated or elliptical profile, wherein the longer axis of the profile extends along the circumferential direction of the base member 210. In the assembled state of the sensor member 200 and the tube assembly 10, the peripheral edge 203 thus contacts the wall of the outer tube 30 that defines the recess 139a. The rear surface 205 of the protrusion 202, facing away from the inner surface of the base member, may be generally flat.

[0137] The thickness of the protrusion 202 in the direction perpendicular to the inner surface of the base member 210 can exceed the thickness of the wall of the outer tube 30, so that the protrusion 202 extends into the recess 48 of the inner tube 40 in the assembled state, such as... Figure 35a , 35b As shown.

[0138] The sensor component 200 also includes a sensor device, not shown in the figures, which may be disposed within the protrusion 202. For example, the sensor device may be a sensor configured to measure the distance of a sensor element relative to a reference position or the displacement of a sensor element, and / or may be a position sensor configured to detect the position of the sensor element. Alternatively, or additionally, the sensor device may be a pressure sensor configured to detect pressure acting on the sensor element. The sensor element of the sensor device (e.g., pin 204) extends from the sensor device to the outside of the protrusion 203. The pin 204 may move to a certain extent relative to the protrusion 202 in the axial direction of the base component 210 (i.e., toward the lower boundary 201a and / or the upper boundary 201b). When the sensor component 200 is mounted on the tube assembly 10, the pin 204 protrudes into a recess 48 of the inner tube and may contact the inclined lower wall portion 48b at the lower end of the recess 48, such as... Figure 35a , 35b As shown. The sensor device is configured to at least detect whether the inclined lower wall portion 48b of the notch 48 contacts the pin 204. The sensor device may also be configured to measure the pressure exerted on the pin 204 by the inclined lower wall portion 48b and / or measure the relative or absolute displacement of the pin 204.

[0139] An indicator 206 is disposed on the outer surface of the base component 210 (i.e., away from the outer tube 30 in the assembled state of the sensor component 200 and the tube assembly 10). The indicator 206 is configured to output optical and / or audible signals in response to measurements from the sensor device. For example, the indicator may be configured to display two visible states, such as a light with different colors, or a switchable on and off light, wherein the first visible state is assigned to the first position of the pin 204 closest to the lower boundary 201a of the base component 210 (see [reference]). Figure 36a ), and the second position in the visible state assigned to pin 204, the second position furthest from the lower boundary 201a (see Figure 36b Alternatively, or additionally, the indicating device 206 may be configured such that when the pin 204 is in the second position furthest from the lower boundary 201a (see...). Figure 36b When it outputs an auditory signal, such as a buzzing sound, it will produce an auditory signal.

[0140] The following is for reference. Figure 25a and 25b as well as Figure 35a , 35b Sections 36a and 36b will explain the function of the sensor component 200 when the device 1' is used to lock and unlock the head 13 in the receiving component 5. Figure 35a The diagram shows the tube assembly 10 of device 1', wherein the sensor component 200 is mounted on the device 1' and is in an unlocked configuration at the head, i.e., wherein the front ends 40a, 30a of the inner tube 40 and the outer tube 30 of the tube assembly 10 have a minimum distance between them (see [reference]). Figure 25a In this configuration, the lower wall portion 48b of the recess 48 of the inner tube is positioned at a certain distance axially below the pin 204 of the sensor component 200; that is, it does not contact the pin 204. (See [reference]). Figure 35a Pin 204 is located in its first position, closest to the lower boundary 201a of the base component 210, as shown. Figure 36a As shown. When device 1' is actuated to lock head 13 ( Figure 25b The inner tube 40 moves axially upward relative to the outer tube 30, such that the lower wall portion 48b of the recess 48 of the inner tube contacts the pin 204 of the sensor component 200, and moves it toward its second position toward the upper boundary 201b of the base component 210. See [link to relevant documentation]. Figure 35b , 36b This causes the indicator device 206 to output optical and / or auditory signals to indicate the locking position of the bone anchoring device to the user.

[0141] Therefore, the sensor component can be used to indicate the locked and / or unlocked state of the head within the receiving component, and thus can provide convenience for instrument manipulation during surgery. Furthermore, when the sensor device is configured to measure the pressure applied to the pin 204 by the inclined lower wall portion 48b and / or the displacement of the pin 204, instrument wear can be detected, for example, based on a decrease in pressure or displacement determined by the sensor device in the locked state of the head.

[0142] The sensor component can be configured to transmit data to external devices, such as computers, navigation devices, trackers, etc. Preferably, the sensor component is configured to wirelessly transmit data to external devices, such as via WiFi, Bluetooth, radio frequency identification (RFID) signals, etc.

[0143] The following will refer to Figures 37 to 41 Another embodiment of the device is described. The device 1'' according to this further embodiment is similar to the device 1 of the first embodiment, and additionally includes a navigation component 300. Components and elements of device 1'' that are identical or similar to those of devices 1 and 1' in the above embodiments are provided with the same reference numerals, and their descriptions are omitted.

[0144] The navigation component 300 is a separate component that can be attached to the tube assembly 10 of the device 1''. Specifically, the navigation component 300 can be mounted on the outer surface of the outer tube 30 below the clamping component 60 by engaging with the notch 139a of the outer tube 30 and the corresponding notch 48 of the inner tube 40, similar to the sensor component 200 of the device 1' described above. The navigation component 300 also includes a base component 210, which is provided with a protrusion 202 and a movable pin 204, similar to the sensor component 200 of the device 1' described above. Instead of the sensor device of the sensor component 200, the navigation component 300 is provided with a navigation device in the form of a navigation star 301. The navigation star 301 is mounted on the outer surface of the base component 210 and, in this embodiment, includes four arms, each arm having a navigation ball 302 disposed at its free end. Another navigation ball 303 is disposed on the outer surface of the base component 201 and connected to the pin 204, such that when the pin 204 is in the first position, the navigation ball 303 can take the first position closest to the lower boundary 201a of the base component 210, and when the pin 204 is in its second position, the navigation ball 303 can take the second position furthest from the lower boundary 201a.

[0145] Based on the position of another navigation ball 303 relative to navigation ball 302, the locking and unlocking mechanism of the head in the receiving component can be determined, and / or the relative displacement between the inner and outer tubes of the tube assembly can be determined. Furthermore, based on the positions of the four navigation balls 302, the position of the instrument can be determined.

[0146] The navigation component 300 does not necessarily need to have four navigation spheres 302 fixedly connected to the base component 210, and can include more or fewer than four navigation spheres 302. For example, the navigation component 300 can typically include one or more navigation spheres 302 fixedly connected to the base component 210, and at least one other navigation sphere 303 that is movable relative to the base component 201 and connected to the movement of the pin 204 in its movement. The relative position or displacement of the navigation sphere 303 connected to the movement of the pin 204 and the at least one fixed navigation sphere can be determined, for example, optically, by means of a light beam reflected by the respective navigation spheres 302, 303.

[0147] The following will refer to Figures 42 to 45 Another embodiment of the device is described. According to this further embodiment, the device 1000 includes a tube 1030 and an outer sleeve 20, which may be similar to the outer tube 30 and outer sleeve 20 of the tube assembly 10 described in the above-described device embodiment. The tube 1030 of the device 1000 may be attached to the aforementioned multi-axis bone anchoring device 2. The device 1000 is used to position and reposition the receiving part 5 of the multi-axis bone anchoring device 2 relative to the bone anchoring element 4.

[0148] refer to Figure 42 Multiple multi-axis bone anchoring devices 2, as described above, are shown to be implanted in corresponding vertebrae 2000. Rods 3 (not shown) can be inserted into at least some receiving parts 5 of the multi-axis bone anchoring devices 2. The tube assembly 10 of the device 1 described in the first embodiment is connected to the first multi-axis bone anchoring device 5, and the tube 1030 of the device 1000 is connected to the second multi-axis bone anchoring device 5. Multiple steps of positioning and repositioning the receiving parts 5 can be performed using the device 1 and / or device 1000 described in the first embodiment. For example, the device 1000 connected to the second bone anchoring device 2 can be tilted and / or rotated to accommodate the position of the multi-axis bone anchoring device 2 relative to the bone anchoring element 4 already inserted into the corresponding vertebrae 2000.

[0149] For further reference Figures 43 to 45 The tube 1030 of the device 1000 defines the longitudinal axis or tube axis L of the device 1000. In the assembled state of the device 1000, the outer sleeve 20 completely surrounds the lower portion of the tube 1030 in the circumferential direction, and the outer sleeve 20 can rotate relative to the tube 1030 about the longitudinal axis L to allow the tube 1030 to engage with the multi-axis bone anchoring device 2.

[0150] The tube 1030 includes a front end 1030a and a rear end 1030b opposite to the front end 1030a. A notch 1032 is formed extending a certain distance from the front end 1030a of the tube 1030. The width of the notch 1032 in the circumferential direction is greater than the upper width of the multi-axis bone anchoring device 2, and its height in the axial direction allows the rod 3 (not shown) to extend through the notch 1032 and move axially within it. A connecting structure 1034 is provided at a certain distance from the front end 1030a of the tube 1030, for example, a circumferentially extending rib formed on the inner surface of the tube. This connecting structure 1034 is adapted to engage a corresponding connecting structure of the multi-axis bone anchoring device 2, such as the groove 84 of the locking ring 8 described above.

[0151] Adjacent to the rear end 1030b of the tube 1030, an attachment feature 1031 may be formed for attachment to another instrument or handle portion (not shown). The attachment feature 1031 may have a polygonal shape on the outer surface of the tube 1030 to allow the other instrument or handle portion to transmit rotational and / or tilting motion to the instrument 1000. An opening 1033 may be provided at a distance from the rear end 1030b to facilitate cleaning or allow insertion of other instruments or components.

[0152] At a certain axial distance from the attachment feature 1031 and / or the opening 1033 and further toward the front end 1030a of the tube 1030, a mark 1071 may be provided to indicate the rotational position of the outer sleeve 20 relative to the tube 1030, similar to the mark 71 of the outer tube 30 of the tube assembly 10 described above.

[0153] At a certain axial distance from mark 1071 and towards the front end 1030a of tube 1030, two engagement features in the form of notches 1036 are provided in the outer surface of tube 1030. Only one of the notches 1036 can be seen in the figure. The notches 1036 are spaced apart in the circumferential direction of tube 1030 and are used to receive corresponding engagement features of outer sleeve 20 in the corresponding rotational positions of outer sleeve 20, such as engagement locks, similar to the notch 36 of outer tube 30 of tube assembly 10 described above.

[0154] The outer sleeve 20 is similar to the outer sleeve of the aforementioned device. For example... Figure 45As shown, the outer sleeve 20 includes a front end 20a, a rear end 20b, and an internal channel extending from the front end 20a to the rear end 20b, wherein the front portion of the tube 1030 can be received in the internal channel of the outer sleeve 20. The circumferential width of the notch 22 formed in the front region of the outer sleeve 20 adjacent to its front end 20a is substantially corresponding to or slightly greater than the diameter of the rod 3, and smaller than the width of the notch 1032 in the tube 1030. The axial length of the outer sleeve 20 between the front end 20a and the rear end 20b can be shorter than the axial length of the tube 1030, and it can be such that when the outer sleeve 20 is assembled with the tube 1030, the rear end 20b is substantially located in the region marked 1071 on the tube 1030, as shown. Figure 43 As shown.

[0155] The locking tab 23 of the outer sleeve 20 is configured to selectively engage one of two notches 1036 provided on the outer surface of the tube 1030, so as to attach the outer sleeve 20 to the tube 1030 in a first rotational position and a second rotational position, as described above for the outer sleeve 20 and the outer tube 30 of the tube assembly. In the first rotational position of the outer sleeve 20, indicated by the “Introduction” indicator (where the first mark 72a of the outer sleeve 20 is aligned with the mark 1071 of the tube 1030), the tube 1030 can be arranged on and removed from the receiving part 5 of the multiaxial bone anchoring device 2. In the second rotational position of the outer sleeve 20, indicated by the “Operation” indicator (where the second mark 72b of the outer sleeve 20 is aligned with the mark 1071 of the tube 1030), the engagement structure 1034 of the tube 1030 engages with the corresponding engagement structure of the multiaxial bone anchoring device 2 and cannot be removed from the multiaxial bone anchoring device 2.

[0156] In use, the device 1000 is first attached to the multiaxial bone anchoring device 2, wherein the bone anchoring element 4 has been implanted in the vertebra 2000 or other bone. The rod 3 can be inserted into the receiving part. The device 1000 is in a first rotational position of the outer sleeve 20 relative to the tube 1030, indicated by the "introduction" indicator, wherein the first mark 72a of the outer sleeve 20 is aligned with the mark 1071 of the tube 1030. In this configuration, the device 1000 is arranged on the receiving part 5 of the bone anchoring device 2 and moves downward in such an orientation that the notch 22 of the outer sleeve 20 is aligned with the basic U-shaped notch 92 of the receiving part 5, which forms a channel for the rod 3, as described above for the device 1. As described above for the device 1, in this configuration, the engagement structure 1034 of the tube 1030 is circumferentially aligned with the ribless outer surface portion 95 of the receiving part 5. The outer sleeve 20 with notch 22 helps to position the instrument 1000 correctly onto the receiving part, and can therefore be used as an alignment part to help attach the tube 1030 to the bone anchoring device 2.

[0157] Next, when the engagement structure 1034 of the tube 1030 is in the same axial position as the corresponding engagement structure of the bone anchoring device, the instrument 1000 rotates to take a second rotational position of the outer sleeve 20 relative to the tube 1030. This position is indicated by an "operation" indicator, wherein the second mark 72b of the outer sleeve 20 is aligned with the mark 1071 of the tube 1030. In this position, the notch 1032 of the tube 1030 can abut against the inserted rod 3 using its circumferential edge. Thus, the tube 1030 rotates relative to the receiving member within the outer sleeve 20 such that the engagement structure at the instrument 1000 (i.e., the rib 1034 of the tube 1030) and the engagement structure at the bone anchoring device (i.e., the groove 84 of the locking ring 8) engage. In the engagement configuration of the instrument 1000 and the bone anchoring device 2, the instrument 1000 can tilt and / or rotate to accommodate the position of the receiving member relative to the bone anchoring element.

[0158] In order to disengage the device 1000, the tube 1030 is rotated back to the “introduced” position of the outer sleeve 20 so that the engagement structure 1034 of the tube 1030 can be removed along the unribbed portion 95 of the receiving member 5, as explained above for the device 1.

[0159] It should be noted that, in addition to or as a substitute for pipe assembly 1, one or more pipes 1030 can be used with corresponding outer sleeves 20 respectively.

[0160] Various variations of the above-described embodiments of the device and bone anchoring device are conceivable. For example, the arrangement, number, construction, and shape of the protrusions forming the driving and driven portions can differ. Although the device is represented together with a bottom-loaded multiaxial bone anchoring device having an external locking ring, the device is not limited to use only with such a device. For example, the device can be used with any type of multiaxial bone anchoring device, wherein the clamping device is axially movable to clamp the inserted head, or with a uniaxial or uniplane bone anchoring device.

Claims

1. An apparatus for use with a bone anchoring device (2), said bone anchoring device (2) comprising a bone anchoring element (4) and a receiving part (5) for connecting a rod (3) to the bone anchoring element (4), wherein, The instruments (1, 1', 1'', 1000) include: At least one tube (10, 30, 40, 1030), said tube (10, 30, 40, 1030) may be attached to the bone anchoring device, said tube defining a longitudinal axis (L), and At least one alignment component (20, 50) is configured to assist in attaching the tube to the bone anchoring device (2).

2. The device according to claim 1, wherein: The alignment components (20, 50) are separate from the tubes (10, 30, 40, 1030) and are preferably attachable to the tubes.

3. The apparatus according to claim 1 or 2, wherein: The alignment component is an external alignment component, preferably in the form of an external sleeve (20), which at least partially, preferably completely surrounds the tube (10, 30, 40, 1030) along the circumferential direction of the tube.

4. The apparatus according to claim 3, wherein: The alignment component (20) is movable relative to the tubes (10, 30, 40, 1030) between a first rotational position and a second rotational position, in the first rotational position the tubes (10, 30, 40, 1030) are attachable to and detachable from the bone anchoring device (2), and in the second rotational position the tubes (10, 30, 40, 1030) are configured to engage the bone anchoring device (2) and prevent removal from the bone anchoring device (2).

5. The apparatus according to claim 3 or 4, wherein: The external alignment member (20) has a first end (20b) and a second end (20a), and includes a notch (22) opening at the second end (20a), the notch (22) being oriented and formed to align with a basic U-shaped notch (92) provided at the receiving member (5) for receiving the rod (3). Preferably, the tubes (10, 30, 40, 1030) have a first end (30b, 40b, 1030b) and a second end (30a, 30b, 1030b), and include a notch (32, 42, 1032) opening at the second end, wherein the width of the notch (22) of the aligning member (20) in the circumferential direction is less than the width of the notch (32, 42, 1032) of the tubes (10, 30, 40, 1030), such that the notch (22) of the aligning member and the notch (32, 42, 1032) of the tube overlap in both the first and second rotational positions to allow the inserted rod (3) to pass through.

6. The apparatus according to any one of claims 1 to 5, wherein: The instrument is a device (1, 1', 1'') for locking and unlocking the head (13) of the bone anchor in the receiving part (5) of the bone anchoring device (2), and the tube is the first tube (40) or the second tube (30) of the tube assembly (10) of the instrument (1, 1', 1''). The pipe assembly (10) includes: At least a first tube (40) and a second tube (30), the first tube (40) and the second tube (30) defining a longitudinal axis (L), the first tube and the second tube being configured to engage a bone anchoring device (2) and being movable relative to each other between a first axial position associated with an unlocking configuration and a second axial position associated with a locking configuration, in which the head (13) is unlocked in a receiving member (5), and in which the head (13) is locked in a receiving member (5); and The at least one alignment member (20, 50) is configured to assist in attaching the tube assembly (10) to the bone anchoring device (2). The device further includes an actuator assembly (100) comprising an actuation mechanism configured to move the first and second tubes of the tube assembly (10) from a first axial position to a second axial position and vice versa. Preferably, the actuator assembly (100) is a separate component that can be connected to and removed from the tube assembly (10).

7. The apparatus according to any one of claims 1 to 6, wherein: The alignment component is an internal alignment component, preferably in the form of a plunger (50), and the internal alignment component is arranged at least partially, preferably completely, within the at least one tube (10, 30, 40, 1030).

8. The apparatus according to claim 7, wherein: The internal alignment member (50) is configured to enter the coaxial hole (91) of the receiving member (5) of the bone anchoring device when the at least one tube is attached to the bone anchoring device. Preferably, the internal alignment member (50) is configured to press against the rod (3) inserted into the receiving member.

9. The apparatus according to any one of claims 6 to 8, wherein: The actuator assembly (100) is configured to take on a first configuration, a second configuration and a third configuration, wherein in the first configuration the tube assembly (10) is configured to take on a first axial position when the actuation mechanism is actuated, in the second configuration the tube assembly (10) is configured to take on a second axial position when the actuation mechanism is actuated, and in the third configuration the actuator assembly (100) is connectable to the tube assembly (10) and / or removable from the tube assembly.

10. The apparatus according to claim 9, wherein: The actuator assembly (100) includes an adjustment member (140) configured to rotate in a circumferential direction to selectively arrange the actuator assembly (100) in a first configuration, a second configuration, or a third configuration. Preferably, the adjustment member (140) is fixed to prevent movement to a position associated with the third configuration.

11. The apparatus of claim 10, wherein: The actuator assembly (100) includes a handle portion (150) that can be connected to the outer sleeve (130) of the actuator assembly. The adjustment component (140) can only move to the position associated with the third structure when the handle portion (150) is disconnected from the outer sleeve (130), particularly when it is turned open to a certain extent.

12. The apparatus according to any one of claims 9 to 11, wherein: The actuator assembly (100) includes at least two drive portions (122, 142) configured to move relative to each other parallel to a longitudinal axis in response to actuation of an actuation mechanism. The tube assembly (10) includes at least two driven portions (45a, 45b) configured to be driven by the drive portions (122, 142). The at least two driven portions (45a, 45b) are circumferentially spaced from each other in correspondence with a first and a second configuration of the actuator assembly (100). Preferably, a gap (G) is provided by the circumferentially spaced driven portions (45a, 45b) to allow the drive portions (122, 142) to enter the tube assembly (10) and define a third configuration of the actuator assembly (100).

13. The apparatus according to any one of claims 6 to 12, further comprising: The sensor component (200) and / or the navigation component (300) are configured to detect at least one of the unlocking and locking configurations of the head (13) in the receiving component (5) or at least one of the first axial position and the second axial position of the first tube and the second tube.

14. An apparatus for locking and unlocking the head (13) of a bone anchor in a receiving part (5) of a bone anchoring device (2), said apparatus (1, 1', 1'') comprising: Tube assembly (10), the tube assembly (10) being attachable to a bone anchoring device, the tube assembly comprising: At least a first tube (40) and a second tube (30) define a longitudinal axis (L). The first tube and the second tube are configured to engage the bone anchoring device (2) and are movable relative to each other between a first axial position associated with an unlocking configuration and a second axial position associated with a locking configuration, in which the head (13) is unlocked in the receiving member (5) and in which the head (13) is locked in the receiving member (5). The device further includes an actuator assembly (100) comprising an actuation mechanism configured to move the first and second tubes of the tube assembly (10) from a first axial position to a second axial position and vice versa. The actuator assembly (100) is configured to take at least a third configuration in which the actuator assembly (100) can be connected to and / or removed from the tube assembly (10), and a retaining mechanism prevents the actuator assembly (100) from taking the third configuration. Preferably, the fixing mechanism can be released by loosening the handle portion (150) of the actuator assembly.

15. A system comprising an instrument and a bone anchoring device, said instrument being the instrument according to any one of claims 1 to 14, wherein, The bone anchoring device (2) includes a bone anchoring element (4) for anchoring in bone and a receiving part (5) for receiving a head (13) of the bone anchoring element, wherein a clamping device (8) is provided, the clamping device (8) acting on the head (13) in the receiving part to lock the head (13) in the receiving part, and the bone anchoring device (2) includes engagement structures (84, 94) configured to be engaged by tube engagement structures (34, 44, 1034) at tubes (10, 30, 40, 1030). Preferably, the receiving component (5) and the clamping device (8) each include a joining structure (84, 94) configured to be joined by tube joining structures (34, 44) at the first tube (40) and the second tube (30), respectively.

Images