WO2023139076A1

WO2023139076A1 - Bone anchor element for inserting into a bone and/or fixing tissue to the bone, insertion instrument and bone anchor system

Info

Publication number: WO2023139076A1
Application number: PCT/EP2023/051040
Authority: WO
Inventors: Fabian HUFSCHMID
Original assignee: Karl Storz Se & Co. Kg
Priority date: 2022-01-24
Filing date: 2023-01-17
Publication date: 2023-07-27
Also published as: DE102022101556A1; DE102022101556B4; EP4468969A1

Abstract

The invention relates to a bone anchor element for inserting into a bone and/or fixing tissue to the bone, wherein the bone anchor element has a longitudinal centre axis and, in a distal direction, a proximal end, a proximal portion, a distal portion and a distal end, and on the inside, from the proximal end to the distal end, a continuous cavity along the longitudinal centre axis with a proximal end opening and a distal end opening and, laterally on its proximal end portion, a through-opening for passing a suture material through, wherein a partially exposed distal opening of the proximal portion is surrounded by an end face of the proximal portion at its distal end, wherein a collar is arranged on the outside of the distal portion, adjacent to the partially exposed distal opening of the proximal portion and/or the through-opening, wherein the collar has at least one receiving surface, oblique with respect to the centre longitudinal axis, for receiving at least one suture material, such that, by means of the collar and/or the through-opening, the bone anchor element can be charged with the at least one suture material in a manner free of knots and/or in a knotted manner. The invention further relates to an insertion instrument and a bone anchor system.

Description

Bone anchor element for insertion into a bone and/or fixing of tissue to the bone, insertion instrument and bone anchor system

[ 01 ] The invention relates to a bone anchor element for introducing into a bone and/or fixing tissue to the bone, the bone anchor element having a longitudinal center axis and a proximal end, a proximal section, a distal section and a distal end in a distal direction, and the bone anchor element having one inside from the proximal end to the distal end

[02] has a continuous hollow space along the longitudinal center axis with a proximal end opening and a distal end opening, the proximal section having a profiled projection on the outside to prevent the bone anchor element introduced into the bone from being pulled off, the distal section being tubular at least at its distal end section and having a feed-through opening on the side at its proximal end section for the passage of a suture material, the feed-through opening being the opening at a distal end of the proximal section is connected to the through cavity via a partially exposed distal-side opening of the proximal section, and the partially exposed distal-side opening is surrounded by a face of the proximal section at the distal end. [ 03 ] Bone anchor elements , also known as bone anchors or bone screws , are used in the medical field to reattach tissue that has been detached from a bone , such as a torn tendon , to the bone again . For this purpose, the bone anchor element usually has at least one hole or a receptacle for threading a thread through it. To introduce the bone anchor element into the bone, a so-called driver or inserter is normally used, which is placed on the proximal end of the bone anchor element.

[ 04 ] When using a bone anchor , a distinction is usually made between knotted and knotless surgical techniques . In the knotted surgical technique, a bone anchor is first placed in the bone with a preloaded suture material. The soft tissue torn off is then brought to its original position with this suture material and then knotted. In the knotless surgical technique, the suture material is first passed through the torn soft tissue and then fixed in the bone with an unloaded anchor. In principle, these two surgical techniques can also be combined.

[05] The disadvantage of known bone anchors is that they are often only designed for either the knotted or the knotless surgical technique. As a result, vendors offer several different families of anchors to cover both knotted and knotless surgical techniques. This means that it must always be checked under an operation whether the The present bone anchor model has the optimal design for the intended surgical technique, or it is necessary to switch between different models of bone anchors at short notice.

[06] Document US Pat. No. 5,690,676 A discloses a suture anchor and a drive assembly, the suture anchor having a rounded or pointed head at its distal end and an elongated proximal section with ribs for locking into a bone, and a through hole for passing a thread through is arranged proximally of the head. Both the suture anchor and the associated driver with a handle and a long shaft can each have grooves for receiving sutures in order to prevent the suture from getting in the way when inserting the suture anchor. This anchor is designed for the knotted surgical technique, in which the suture anchor preloaded with the suture is placed in the bone and the suture is then passed through the soft tissue and knotted.

[07] US 2012/0053629 A1 describes a knotless suture anchor with a smooth distal nose and a tubular body, the suture anchor having a lateral passage for guiding a thread into the cavity of the tubular body and through its distal-side opening to the outside. Likewise, the loop of a threader can be pushed through this lateral opening. For this purpose, the associated introducer has a proximal slot for inserting the loop of the threader into the hollow shaft of the Introducer on, whereby the sling is guided outwards again over a ramp of the introducer through a distal slit before it enters the lateral passage of the suture anchor. A preloaded suture anchor for a knotted surgical technique is not disclosed in US 2012/0053629 A1.

[08] Another knotless, labral anchor is described in US Pat. No. 9,867,607 B2, which has a cannulated cavity for threading through, the anchor being connected on the proximal side to a driver, which has a slot at its distal end for threading through. The end of the thread guided outwards through this slit is penetrated on the outside by a loop of a thread-threading instrument. This suture end is then passed through soft tissue and tightened using the loop of the suture passing instrument, while a static knot present at the distal opening of the anchor connected to the other suture end is also pulled and the anchor is connected to the bone. Due to the static knot that has to be set first and the suture threading instrument being guided through one suture end, this anchor cannot be flexibly loaded and used.

[09] WO 2017/106608 A2 also describes a cannulated, knotless anchor implant with an external circumferential thread and a distal-side opening, the anchor implant being connectable at its proximal end to a hollow shaft of a driver, which has a slot at its proximal section for inserting a Has suture in its cavity and for performing up to the distal opening of the anchor element. Likewise, the loop of a threader can be pushed through this slot past the distal end of the anchor implant to catch a suture and withdrawn.

[10] The disadvantage of known bone anchor elements and/or systems is that they can often only be used in the knotted or knotless surgical technique and/or the loading of the bone anchor system is strongly predetermined and cannot be flexibly adapted intraoperatively.

[ 11 ] The object of the invention is to improve the state of the art .

[ 12 ] The object is achieved by a bone anchor element for introducing into a bone and/or fixing tissue to the bone, the bone anchor element having a longitudinal center axis and, in a distal direction, a proximal end, a proximal section, a distal section and a distal end, and the bone anchor element having a continuous cavity along the longitudinal center axis from the proximal end to the distal end with a proximal end opening and a distal end opening wherein the proximal section has a profiled projection on the outside to prevent the bone anchor element introduced into the bone from being pulled off, the distal section being tubular at least at one of its distal end sections and at its proximal end section laterally has a through-opening for threading through, wherein the through-opening at a distal end of the proximal section is connected to the continuous cavity via a partially exposed distal-side opening of the proximal section, and the partially exposed distal-side opening is surrounded by an end face of the proximal section at its distal end, being adjacent to the partially exposed distal-side opening of the proximal section and/or the through-opening a collar is arranged on the outside of the distal section, the collar having at least one receiving surface for at least one suture material, which is aligned obliquely to the longitudinal center axis, so that the bone anchor element can be loaded with the at least one suture material in a knotless and/or knotted manner by means of the collar and/or the through-opening.

[ 13 ] A bone anchor element is thus provided which can be used multifunctionally in the knotted and / or knotless surgical technique . Due to the multifunctional design, the bone anchor element can be prefabricated and/or loaded with a suture material during an intervention, in particular outside of the body to be treated. Consequently, a wide range of applications and diverse functions can be covered with a single design of a bone anchor element.

[ 14 ] Thus, the bone anchor element for various

Shoulder indications, such as reconstruction of the

Rotator cuff, bi ceptenodesis, reconstruction of the Deltoid muscles, reconstruction of Bankart lesions, reconstruction of SLAP lesions, correction of the acromioclavicular joint rupture, can be used for capsule displacements and/or capsulolabral reconstructions.

[ 15 ] As a result, a single bone anchor element is available, which can be used for various surgical techniques and for flexible loading with the suture thread.

[ 16 ] By means of the collar with its at least one receiving surface and / or the feed - through opening , the bone anchor element provides several different options for guiding the thread , which can be flexibly and / or intraoperatively adapted and / or used for the respective desired application . Because of the versatile bone anchor element, it is not necessary to work out two or more concepts for use and loading as well as for placing the suture under the operation in advance.

[ 17 ] In addition, a pre-loading of the bone anchor element with a thread can be combined with an additional flexible loading with a second thread or other threads during the operation, so that a medial row can be realized with a knotted design of the bone anchor element and a lateral row with a knotless design of the bone anchor element.

[ 18 ] An essential idea of the invention is based on providing a bone anchor element which has both a feed-through opening and a collar on the outside with at least one slanted section on its distal section aligned receiving surface for the thread material, wherein the inclined receiving surface enables targeted guidance and sliding of the thread material. The bone anchor element can be flexibly pre-loaded manually and/or with a threading aid and/or during an operation due to the continuous hollow space, the feed-through opening and the collar arranged on the outside.

[ 19 ] As a result, the bone anchor element can be used not only for fixing a tendon in the shoulder and/or hip area, but also for a large number of other operations to fix soft tissue, such as ligaments, joint lips, rotator cuffs or torn capsules.

[ 20 ] The following terms should be explained :

[ 21 ] A "bone anchor element" (also called "bone anchor", "bone screw", "suture anchor" or "interference screw") is in particular an element for introducing into a bone and/or fixing tissue, in particular detached tissue, to the bone. Thus, a bone anchor is in particular an implant for anatomical fixation. The bone anchor has in particular a proximal section and a distal section ig or the two-part sections are firmly connected to one another.The bone anchor element has, in particular, a biointegrable material (PEEK), exhibit. The material of the bone anchor element is, in particular, transparent to X-rays and reliable in MRI (magnetic resonance imaging). The bone anchor element in the uniform design according to the invention can in particular be provided in different anchor sizes. In principle, the different size variants do not differ in terms of design, surgical technique, application and/or loading properties.

[ 22 ] "Proximal" is understood to mean the end of an object, such as the bone anchor element or an inserter, which is in the direction towards the body of the user and/or surgeon. Correspondingly, the respective "distal end" or "distal section" is understood to be the end or section which is on the side of the object remote from the operator of the object and consequently on the side of the bone and/or body to be operated on. Thus the distal end of the bone anchor element is introduced into the bone at a distance from the surgeon.

[ 23 ] A "longitudinal central axis" is understood in particular to mean that axis of the bone anchor element which corresponds to the direction of its greatest extension and/or dimension.

[ 24 ] A "proximal section" (also referred to as "proximal body") has in particular a base body which is designed in the longitudinal direction along the longitudinal center axis as a hollow body and preferably as a hollow cylinder with a round cross section. Of course it can the proximal section can also have an oval, triangular, quadrilateral or polygonal cross-section. At its proximal end, the proximal section has, in particular, the proximal terminal opening, which borders on the interior of the through cavity, which in turn is designed to be continuous up to the partially exposed distal-side opening of the proximal section. The proximal section transitions into the distal section at the partially exposed distal-side opening of the proximal section.

[ 25 ] The "cavity" (also called "lumen") is in particular a hollow space inside the bone anchor element, which is guided from the proximal end opening along the longitudinal central axis to the distal end opening of the bone anchor element. The continuous hollow space can be designed, for example, as an axially continuous bore. However, this bore does not necessarily have to have a round cross section, but can also have a polygonal, such as hexagonal, cross section. When loading the bone anchor element without knots, a threading aid and/or a thread can run through the continuous hollow space. The entire body of the bone anchor element is cannulated through the continuous hollow space and thus enables blood to circulate after implantation.

[ 26 ] The proximal section has in particular at its

Outside a profiled projection or more profiled projections. With a “profiled Projection" is, for example, a rib or several ribs. The rib or the ribs can be arranged on one side, circumferentially and/or offset. The profiled projection can also be designed as a thread. In this case, a continuous thread at the proximal end of the proximal section preferably begins on the outside with a flat threaded section and ends at the distal end of the proximal section, also flush with a flat threaded section. Depending on the design of the profiled projection, the bone anchor element is screwed in and/or hammered into the bone anchorable .

[ 27 ] At the distal end of the profiled projection and / or at the partially exposed distal opening of the proximal section , the proximal section transitions into the distal section . The distal section is, in particular, of tubular design. If the distal section is tubular, it does not necessarily have to have a circular cross section, but can also have an oval, triangular, square and/or polygonal cross section. The distal section has a feed-through opening, in particular in its side wall, which is connected on the proximal side to the cavity of the proximal section and on the distal side to the cavity of the distal section up to the distal end opening. Because the feed-through opening at least partially uncovers the distal end of the proximal section, there is a partially uncovered distal opening in the proximal section before, which is surrounded by a partially formed end face. The distal section has a collar in particular on the outside, the collar having in particular a larger diameter than the tubular distal end section of the distal section. The collar thus represents a receiving part which is guided laterally adjacent to the partially exposed distal-side surface of the proximal section and/or laterally to the through-opening. In the distal direction, the collar in particular directly adjoins the profiled projection and/or the end face of the proximal section of the bone anchor element. The collar has in particular a receiving surface for a thread material oriented obliquely to the longitudinal center axis or a receiving surface oriented obliquely to the longitudinal center axis on both sides. The collar is preferably designed with a collar flank running obliquely all the way around the tubular distal section. This provides a specifically aligned receiving and sliding surface for a thread material.

[ 28 ] The term "adjacent to" is understood in particular to mean that the collar is arranged in the distal direction directly adjacent to the exposed distal-side opening, the last distal-side thread turn of the profiled projection and/or the end face of the proximal section. "Adjacent to" the through-opening is understood in particular to mean that the collar is arranged laterally outside the through-opening. Here can the collar can be arranged directly or at a distance from the opposing side walls of the through-opening.

[ 29 ] A "through-opening" is understood in particular as a continuous opening through a side wall of the distal section. The through-opening can in particular be a hole transverse to the central longitudinal axis of the bone anchor element in the distal section. The through-opening has in particular a dimension parallel to the central longitudinal axis and a transverse dimension transverse to the central longitudinal axis of the bone anchor element fuhröf fnung in particular in front of the longitudinal center axis.

[ 30 ] A "thread material" is understood to mean in particular a surgical thread or several surgical threads. The thread material has in particular UHMWPE (Ultra-High-Molecular-Weight Polyethylene). A thread material can be, for example, two USP #2 threads or two suture tapes, for example with a width of 1.3 mm.

[ 31 ] "Loadable in a knot" is understood in particular to mean that the bone anchor element is unloaded, the thread material is first guided through a torn soft tissue and then fixed in the bone with the unloaded bone anchor element. "Loadable in a knotted manner" is understood in particular to mean that the bone anchor element is first preloaded with a thread material and is thus preloaded and/or is placed pre-assembled in the bone. The soft tissue that has been torn off is then brought into its original position with the thread or threads attached to the bone anchor element and knotted.

In another embodiment of the bone anchor element, the collar has a receiving surface on both sides of the partially exposed distal opening of the proximal section and at least partially on both sides of the feed-through opening in the distal direction.

[ 33 ] The receiving surfaces in the distal area of the bone anchor element , which are oriented obliquely on both sides to the longitudinal central axis , serve as a sliding surface for preloaded sutures and thus , in particular , for a knotted surgical technique . In the distal direction, the receiving surfaces on both sides, which are oriented obliquely to the longitudinal center axis, run away obliquely from the through-opening to the opposite side of the through-opening. The inclined position of the geometry increases the loaded cross-section of the bone anchor element and thus improves the force distribution. This improved force distribution increases the mechanical stability of the bone anchor.

[ 34 ] In addition, the sloping collar with its sloping receiving and sliding surfaces on both sides protects the pre-loaded threads from damage when the bone anchor element is introduced into the core hole and/or drill hole in the Bone . After the bone anchor element has been inserted and/or screwed in, the threads lie freely on the receiving surfaces of the sloping collar and can thus be manipulated by a doctor, as is necessary for the formation of knots.

[35] In order to provide a direction reversal of the thread guide and/or two manipulable thread ends, the collar is formed from a side wall of the through-opening radially around the distal section to an opposite side wall of the through-opening.

[ 36 ] Thus , a thread can be guided centrally around the partially radially surrounding collar and with its two thread ends through the feed - through opening into the cavity of the bone anchor element . Consequently, a thread can be guided radially circumferentially on the receiving surface of the collar, around the tubular end section of the distal section and in the proximal direction along the receiving surfaces on both sides, which are oriented obliquely to the longitudinal central axis.

[ 37 ] In a further embodiment of the bone anchor element, the collar is connected on both sides via a curve to the end face of the proximal section, so that a seat on both sides for the thread material is formed approximately parallel to the longitudinal center axis in the distal direction, followed in each case by the receiving surface oriented obliquely to the longitudinal center axis. [38] Thus, due to the double-sided rounding in the transition area between the end face and the collar, a defined support surface and thus a seat for the suture material is provided on both sides, whereby the suture ends are held and guided by the respective seat through the feed-through opening into the cavity of the bone anchor element. The defined guidance and the fact that the thread material lies in the curve also prevents damage to and wear of the thread material when it is pulled through.

[ 39 ] "Approximately parallel to the longitudinal center axis" means in particular that the main alignment of the seat surface is essentially parallel to the longitudinal center axis. However, since the seat is designed with a curve and forms a transition between the end face of the proximal section and the sloping receiving surface of the collar, this is not a consistently flat horizontal surface parallel to the longitudinal center axis.

[40] In order to provide a beyond the inclined recording area defined and then partially form the collar in a distal direction at the end of the first sloping absorption area as a connection between the two sloping reception areas, the absorption surface and/or show the inclined absorption surface. to 80 °, especially from 30 ° to 60 °, preferred from 40 ° to

50°, to the longitudinal central axis. [41] This ensures that the suture material is guided in a defined manner along and around the distal section and that the ends of the suture are pulled in a defined direction.

[42] In a further embodiment of the bone anchor element, the through-opening has four inside corners in a plan view.

[43] An "internal corner" is understood in particular to mean that the angle of the corner, viewed from the inside, is less than 180°. The internal corner is in particular a point at which two side walls of the distal section, which adjoin the inner through-opening, meet.

[44] In order to guide the threads in a defined manner through the through-opening as a window in the side wall of the distal section, the four inner corners of the through-opening each have a rounding.

[45] As a result, the through-opening has a square, rounded shape. Due to the radii in the inner corners of the square of the through-opening, the suture material can be drawn in better, for example with the help of a drawing-in aid, and then manipulated in order to provide a knotted surgical technique. Due to the design of the respective inside corner with a curve, a guided seat for guiding the thread through the feed-through opening, a defined position of the thread feed-through and a separate guidance of threads are also provided. In addition, the respective rounding of the Inside corner prevents damage and wear when moving and manipulating threads.

[ 46 ] "Rounding" means in particular that the respective inside corner is not angular and/or designed with an acute angle, but rather as a rounding with a partial radius.

[ 47 ] In a further embodiment of the bone anchor element , the distal end , a distal end section of the distal section and / or the distal section tapers conically in the distal direction and / or is rounded .

[48] Because the distal end of the bone anchor element is tapered and/or rounded, the bone anchor element can be optimally inserted into the prepared core hole in the bone and/or in the joint, and injury to the patient and/or damage to the bone anchor element during insertion is prevented. Due to the fact that the distal end section of the tubular distal section tapers conically in the distal direction, a

Self-centering of the bone anchor element takes place, which simplifies insertion and shortens the operation time.

[ 49 ] In order to further improve safe and rapid centering of the bone anchor element in the core hole of the bone, the profiled projection is designed as a circumferential thread, which extends in the distal Direction at the distal end of the proximal section ver j üngt.

[ 50 ] Thus , the thread , for example a cortical thread , has a conical inlet at its distal end , while the remaining thread is cylindrical up to the proximal end of the bone anchor element .

[ 51 ] In another embodiment of the bone anchor element , a core diameter of the circumferential thread increases counter to the distal direction towards the proximal end of the proximal section .

[52] Due to the fact that the core diameter of the circumferential thread in the distal and central area of the proximal section is cylindrical and increases towards the proximal end, the compression of the bone is increased during insertion at the proximal end, which results in better fixation in the cortical bone of the bone.

[ 53 ] The "core diameter" is in particular the smallest diameter on a thread. The core diameter is in particular an imaginary cylinder (internal cylinder) which excludes the profile peaks of the thread.

[ 54 ] In order to ensure better ingrowth of the bone anchor element in the healing phase, the proximal section has a plurality of perforation holes which are each arranged axially symmetrically to the longitudinal central axis and/or offset in the distal direction. [ 55 ] A mechanical connection between the bone anchor and the bone is increased by the perforations on the surface of the bone anchor element and / or by its side walls . For this purpose, the perforations can be spaced at an angle of four times 90° and distributed around the outer surface of the bone anchor element, with the perforations and/or bores being preferably offset in the axial direction and thus along the longitudinal central axis of the bone anchor element in order to prevent a weakening of the anchor stability. As a result, two perforation holes are never opposite one another and consequently a weakening of the cross-section is avoided. In addition, a healing of the bone anchor element evenly into the bone is accelerated at the same time by the perforation holes formed offset to one another around the circumference along the longitudinal central axis.

[ 56 ] In a further embodiment of the bone anchor element , the proximal terminal opening and / or the proximal section has an internal driving profile , in particular a hexagonal socket profile .

[ 57 ] An inserter ( also known as a driver ) can be connected to the bone anchor element for inserting the bone anchor element into the drilled hole in the bone via the internal driving profile .

[ 58 ] Thus, the necessary axial force and / or a

Torque applied to the inserter and via the Internal driving profile are transferred to the bone anchor element for screwing and / or hammering into the bone. The internal entrainment profile is in particular guided from the proximal end to the distal end of the proximal section, the end face and/or the breakthrough opening in the distal section. As a result, the shaft of an inserter can be guided flush through the entire cavity of the proximal section of the bone anchor element. The hexagon socket profile has, in particular, a width across flats of 2.75 mm. The internal entrainment profile is formed in particular at least at the proximal opening in the distal direction along the longitudinal center axis in the inner wall of the proximal section around the continuous cavity. In addition to the formation of the internal driver profile along the entire continuous cavity of the proximal section, the internal driver profile can also be configured only in the initial area of the continuous cavity of the proximal section.

[ 59 ] In a further embodiment, the bone anchor element has an anti-rotation element at its proximal end and/or at the proximal end opening.

[ 60 ] Thus, after attaching and/or connecting an insertion instrument to and/or in the bone anchor element, the bone anchor element is prevented from twisting relative to the insertion element, for example while it is being screwed into the bone. In addition, it can be ensured that the bone anchor element is connected to the insertion instrument in a defined alignment and as a result the wire loop of a threader can always be pushed through the feed-through opening in a targeted manner on the same side of the distal section.

[ 61 ] In a further aspect of the invention, the object is achieved by an insertion instrument for inserting a bone anchor element into a drill hole in a bone, the insertion instrument having a tool shank in a longitudinal direction, a handle being arranged on a proximal end of the tool shank and a driver profile for connection to the bone anchor element being arranged in an opposite, distal end section and the tool shank having a continuous hollow space in the longitudinal direction, the tool shank having a spiral-shaped indentation along the longitudinal direction on its proximal section , wherein the spiral-shaped recess is connected to the continuous cavity, so that when the insertion instrument is connected to the bone anchor element, a thread material can be inserted into the continuous cavity by means of the spiral-shaped recess or guided out of the continuous cavity and/or can be tensioned by rotating the insertion instrument.

[ 62 ] Thus, an insertion instrument is provided, with which a previously described bone anchor element after connecting the distal end of the inserter to the proximal section of the bone anchor element in a Borehole introduced within a bone and can be anchored there by hammering and/or screwing.

[ 63 ] Consequently , an insertion instrument with a helical thread exit and / or entry is provided . Due to the spiral-shaped groove as a guide for the thread, if the thread is held taut while the bone anchor element is being screwed in, it is guided further upwards by the insertion instrument into the groove windings and is thus tensioned. The tension of the thread is thus maintained, adjusted and/or can be adjusted in a targeted manner during insertion. This prevents the thread from being wound around the outside of the shaft of the inserter when the bone anchor is being screwed in, which would result in undesired tension and the user first having to unwind the thread before the thread can be used again.

[ 64 ] A "insertion instrument" (also called "insertor") is in particular a tool for inserting a bone anchor into a drilled hole in a bone. The insertion instrument can already be prefabricated with a thread or the thread is threaded through after the bone anchor element has been connected to the inserter. The insertion instrument and/or a threader can thus be used for knotless and knotted loading of the bone anchor. The insertion instrument has a handle, for example made of plastic, in particular at the proximal end, and a driver profile is arranged at the distal end. The insertion instrument is intended in particular for single use and is discarded after use. The insertion instrument is therefore in particular a sterile single-use product.

[ 65 ] The tool shank of the consignor is preferably electropolished and passivated . The tool shank is designed partially or completely as a hollow shank, with the hollow space being connected to the spiral-shaped recess. The length of the tool shank and/or the spiral-shaped recess is/are adaptable in particular to the intended use. For example, the tool shank for a hip operation is 80 mm longer than for a shoulder operation. The tool shank can also have a different diameter, depending on the application. The insertion instrument can preferably be used universally for different sizes of bone anchor elements.

[ 66 ] A "spiral depression" (also called a spiral groove) is in particular a cutout in the longitudinal direction of the tool shank in the area of its proximal and/or distal section, with the cutout going through from the outside into the interior cavity of the tool shank.

[ 67 ] "In the longitudinal direction" is understood to mean the direction of the longest extent and/or dimension of the insertion instrument. The longitudinal direction is therefore in particular also the direction in which the bone anchor element is inserted into a bone. [ 68 ] A "bore hole" (also called "core hole") is a hole made in the bone by drilling, hammering in, or in some other way.

[ 69 ] In another embodiment of the insertion instrument , the driver profile has an external driver profile , in particular an external hexagonal profile , for connection to the bone anchor element .

[ 70 ] As a result , the external driver profile can be used to optimally connect and force transfer the insertion instrument to an internal driver profile , in particular a hexagonal socket profile , of the bone anchor element . In this case, the inside driver profile of the bone anchor element and the outside driver profile of the insertion instrument are designed to correspond and work together. Consequently, the insertion instrument represents a hex drive for the bone anchor element.

[ 71 ] In order to ensure a defined alignment of the bone anchor element at the distal end of the insertion element and to prevent the connected bone anchor element from twisting, the insertion instrument has in particular an anti-twist element, so that when the insertion instrument is connected to a bone anchor element by means of the driver profile, the connected bone anchor element cannot twist

Bone anchor element is prevented. [ 72 ] This ensures that both the spiral depression in the tool shaft of the insertion instrument and the outlet of the wire loop through the opening are on the upper side of the insertion instrument and the bone anchor .

[ 73 ] In order to ensure a self-retaining function of the bone anchor element on the insertion instrument, the driver profile has an increasing outer diameter towards its proximal end.

[74] Due to the fact that the hexagonal geometry widens conically in the proximal part of the driver profile, a secure hold of the bone anchor element is ensured even when forces are applied for insertion or when it slips off to the side during insertion.

[ 75 ] In another embodiment of the insertion instrument , the tool shank has a marking for a predetermined insertion depth of the bone anchor element .

[ 76 ] The marking, for example a circumferential laser marking, shows the user the maximum insertion depth directly when screwing in the bone anchor element.

[ 77 ] In a further embodiment of the insertion instrument, the handle has a recess and/or a coil for receiving a thread material. [ 78 ] Thus , the insertion instrument loaded with a thread material and / or a bone anchor element can be provided already prefabricated . Likewise, after loading a bone anchor element with a thread, the two ends of the thread can be received in the recess or in several recesses of the handle of the insertion instrument and/or wound onto its spool. The thread ends are preferably guided flush and close-fitting at the side of the handle in the longitudinal direction to the proximal end. The coil for winding up protruding thread material is preferably formed at the proximal end of the handle.

[ 79 ] In a further aspect of the invention, the object is achieved by a bone anchor system with a bone anchor element as described above and an insertion instrument as described above, so that the insertion instrument can be connected to the bone anchor element, a thread material can be flexibly threaded through the bone anchor element and/or the bone anchor element can be inserted into a drill hole in a bone using the insertion instrument.

[ 80 ] A bone anchor system is thus provided which can be configured in such a way that it can be used for the knotted and / or knotless surgical technique . In particular, the bone anchor element in the bone anchor system can be flexibly preloaded and/or reloaded during an operation, in particular outside the body. [ 81 ] In another embodiment, the bone anchor system is assigned a threader with a finger grip and a wire loop, or the bone anchor system has a threader with a finger grip and a wire loop, so that when the insertion instrument is connected to the bone anchor element, the wire loop of the threader can be threaded from the outside through the spiral-shaped depression in and through the cavity of the tool shaft of the insertion instrument, through the continuous cavity of the bone anchor element to can be slid out of the feed-through opening or out of the terminal distal opening and a thread material can be threaded into the wire loop.

[ 82 ] Thus , a bone anchor system with an unloaded bone anchor element is provided for a knotless surgical technique in which the bone anchor element is loaded with the suture during the operation .

[ 83 ] A "wire loop" (also called an eyelet) is understood to mean in particular a loop of wire. A wire loop can also be a metal loop and/or metal eyelet. A wire loop can in particular be a loading wire bent into a loop. A wire loop is also understood to mean a suture thread bent into a loop. The wire loop is in particular at the end of a wire or seam that is bent back thread, whereby the two wire ends or suture thread ends are held together by the threader, are attached to this or otherwise, for example manually, are held together. To hold the threader (also called threading aid or pull-in aid), it has a finger grip, particularly at its proximal end.

[ 84 ] Thus, in a knotless surgical technique using the threader as a pull-in aid, a thread material accommodated in the wire loop of the threader can be guided through the bone anchor element and the hollow tool shaft of the insertion instrument, with the thread then emerging from the spiral-shaped groove. This subsequent loading of the bone anchor element usually takes place outside of the joint and/or bone.

[ 85 ] In order to also implement a knotted surgical technique with a pre-loaded bone anchor element, the bone anchor system has at least one thread material in a further embodiment, the insertion instrument being connected to the bone anchor element, the thread material having two thread ends and being arranged on the outside of the collar of the bone anchor element, the two thread ends through the through-opening inwards in the proximal direction through the continuous cavity of the proximal section of the bone anchor element, the cavity of the tool shank of the insertion instrument and are guided outwards through the spiral-shaped recess of the insertion instrument and/or are attached to the handle of the insertion instrument, so that there is a prefabricated bone anchor system. [ 86 ] Thus, a flexible , adaptable

Bone anchor system provided with which the refixation of soft tissue can be realized in different ways and through different approaches with a single bone anchor element and a single bone anchor system. Thus, for example, reconstructions and a correction of instabilities for rotator cuffs can be realized in different ways.

In a further aspect of the invention, the object is achieved by a method for assembling a bone anchor system using a bone anchor element as described above and an insertion instrument as described above or using a bone anchor system as described above, with the following steps:

connecting the distal end of the insertion instrument to the proximal end of the bone anchor element,

Insertion of a wire loop of a threader from the outside into the spiral depression in the cavity of the tool shaft of the insertion instrument,

Pushing the wire loop through the hollow space of the tool shaft of the insertion instrument and through the through hollow space of the bone anchor element to the outside from the through-opening or from the terminal distal opening of the distal section of the bone anchor element, threading a suture thread of the suture material through the wire loop,

withdrawing the threader from the helical depression so that the wire loop is guided in a proximal direction through the continuous cavity of the bone anchor element and the cavity of the tool shaft of the insertion instrument,

Pull the threader with the wire loop out of the spiral depression so that at least one end of the thread can be attached to the handle of the insertion instrument and/or can be held by the user.

In a further aspect of the invention, the object is achieved by a method for preloading a bone anchor element of a bone anchor system, using a bone anchor element described above and an insertion instrument described above, or using a bone anchor system described above, with the following steps:

Insertion of a wire loop of a threader from the outside through the spiral-shaped indentation into the cavity of the tool shaft of the insertion instrument,

Pushing the wire loop through the cavity of the tool shaft of the insertion instrument and through the continuous cavity of the bone anchor element to the outside from the through-opening,

Laying a suture thread around the collar of the distal section of the bone anchor element so that the two thread ends are aligned in a proximal direction,

Passing the two thread ends through an eye of the wire loop,

Withdrawing the threader from the spiral-shaped recess so that the wire loop with the threaded two ends of the thread through the continuous cavity of the bone anchor element and the cavity of the tool shaft of the insertion instrument in the proximal

direction is pulled

Pull the two suture ends out of the spiral-shaped indentation in the tool shaft of the insertion instrument , and

Hold or fasten the two ends of the suture thread to the inserter's handle so that the bone anchor system can be used pre-assembled and loaded in a knotted surgical technique.

[ 89 ] The invention is explained in more detail below using exemplary embodiments . Show it

Figure 1 is a perspective view of a

Bone anchor in a side plan view from above, Figure 2 is a perspective view of the

Bone anchor from Figure 1 in side view,

Figure 3 is a perspective view of the

Bone anchor from Figure 1 in a plan view,

FIG. 4 shows a perspective representation of a distal end of the bone anchor in a plan view,

FIG. 5 shows a perspective representation of a proximal end of the bone anchor in a plan view,

Figure 6 is a perspective view of a

consignor in a side view,

Figure 7 is a perspective view of a

Enlargement of a distal end of the introducer from FIG. 6,

FIG. 8 shows a perspective representation of a prefabricated bone anchor system in a side view,

Figure 9 is a perspective view of a

Enlargement of a handle and a proximal section of a tool shank of an inserter of the prefabricated bone anchor system, Figure 10 is a longitudinal section through a

Bone anchor connected to the inserter's tool shaft with a loaded suture from the prefabricated bone anchor system,

Figure 11 is a perspective view of the

Bone anchor with a thread guided around a collar in a lateral plan view of the prefabricated bone anchor system,

FIG. 12 is a perspective view of the prefabricated bone anchor system being screwed into a model bone,

FIG. 13 is a perspective view of the prefabricated bone anchor system when the inserter is pulled out,

Figure 14 is a perspective view of the

Bone anchor introduced into the model bone,

Figure 15 is a perspective view of a

Bone anchor system with an inserter, a threader and a bone anchor for a knotless surgical technique,

Figure 16 is a perspective view of the distal portion of a tool shank of the inserter with the connected bone anchor and pushed-through eyelet with suture from Figure 15,

Figure 17 is a perspective view of the

Bone anchor system from Figure 15 when the threader is pulled out of a spiral-shaped groove in the hollow shaft of the inserter,

Figure 18 is a perspective view of the

Bone anchor system from Figure 15 with a thread exiting the spiral groove of the hollow shaft of the inserter,

Figure 19 is a perspective view of the

Bone anchor system from Figure 15 when screwing the inserter into a model bone,

Figure 20 is a perspective view of the

Bone anchor system from FIG. 15 with a bone anchor screwed into the model bone,

Figure 21 is a perspective view of the

Bone anchor system from FIG. 15 when the inserter is pulled out, and FIG. 22 shows a perspective representation of the bone anchor introduced into a drilled hole in the model bone.

[ 90 ] A bone anchor 101 has a longitudinal central axis 113 , a proximal section 107 followed by a distal section 109 being arranged in the distal direction 111 from its proximal end 103 to its distal end 105 ( see FIGS . 1 to 3 ) . On the inside, the bone anchor 101 has a continuous longitudinal bore 117 from a proximal end opening 119 to a distal end opening 121 (see Figure 4 and

5) . A continuous, circumferential thread 115 is arranged on the outside along the proximal section 107 and ends flat with a thread trough at the proximal end 103 and at the distal end of the proximal section 107 . A core diameter 145 of the thread 115 is constant in the distal and central area of the proximal section 107 and increases counter to the distal direction 111 towards the proximal end 103, which increases compression when the bone anchor 101 is introduced into a bone and thereby improves fixation.

[ 91 ] Furthermore, the proximal section 107 has several perforation holes 139 in the thread valleys, which are regularly spaced across a cross-sectional surface and lateral surface of the proximal section 107 in the distal direction 111 in order to improve later ingrowth of a bone into the bone anchor 101 . [ 92 ] The distal section 109 of the bone anchor 101 is tubular and tapers slightly in the distal direction 111 to the distal end 105 . The distal section 109 has a rounding 137 around the distal end opening 121 . Both favor an introduction of the bone anchor 101 into a bone. In its proximal region, the distal section 109 has a feed-through opening 123 in its side wall, which is formed with two opposing side walls 129 both transversely to the longitudinal center axis 113 and along the longitudinal center axis 113 . Due to the feed-through opening 123 , an end face 143 of the proximal section 107 is partially exposed and the feed-through opening 123 is connected to the inner longitudinal bore 117 . In a plan view (FIG. 3), the feed-through opening 123 is rectangular with four inside corners 133, each inside corner 133 being rounded with a rounding 135 in order to guide a thread without damaging it.

[ 93 ] In its proximal area , the distal section 109 has a peripheral collar 125 , which has two inclined sliding surfaces 127 on both sides at an angle of 45 ° to the longitudinal center axis 113 . The collar 125 is formed circumferentially around the tubular area of the distal section 109 on a side opposite the feed-through opening 123 . The two sliding surfaces 127 on both sides of the collar 125 are each connected to the end face 143 in the proximal direction via a thread seat 131 . The respective thread seat 131 is formed approximately parallel to the longitudinal central axis 113 in its central region in order to ensure a secure fit of a thread.

The proximal section 107 has a hexagon socket profile 141 on the inside (see FIG. 5), which is guided from the proximal terminal opening 119 to the area of the end face 143, with the bone anchor 101 being able to be connected to an inserter 201 via the hexagon socket profile 141.

[ 95 ] The inserter 201 for knotless and knotted loading of the bone anchor 101 has a handle 207 with a receiving slot 215 formed in a longitudinal direction 205 . The handle 207 has a thread spool 211 at its proximal end. A hollow shaft 203 is arranged at the distal end of the handle 207 . The hollow shaft 203 of the introducer 201 has a spiral groove 209 along the longitudinal direction 205 in its proximal area. An external hexagon profile section 213 for connection to the internal hexagon profile 141 of the bone anchor 101 is arranged at the distal end of the hollow shaft 203 (see FIG. 6). The cross section of the external hexagonal profile section 213 has a width across flats of 2.75 mm. The external hexagon profile section 213 has a conical widening 217 on its proximal section, as a result of which a self-retaining function of the bone anchor 101 on the external hexagon profile section 213 of the inserter 201 is ensured. The hollow shaft 203 has a marking 219 at its distal end, which as circumferential laser marking is formed and when screwing in the bone anchor 101 indicates the maximum insertion depth. The handle 207 is made of plastic and the hollow shaft 203 is made of metal.

[ 96 ] A threader 301 has a finger grip 303 and a wire section 307 adjoining it on the distal side with an eyelet 305 at its distal end .

[ 97 ] A prefabricated bone anchor system 400 has a bone anchor 101 preloaded with a thread 223 , which is connected to the external hexagon profile section 213 of the hollow shank 203 of the inserter 201 by means of its internal hexagon profile 141 . For preloading the bone anchor 101, an eyelet 305 with the wire section 307 of the threader 301 has been pushed from the outside through the spiral groove 203 into the cavity 239 of the hollow shaft 203 until the eyelet 305 protrudes through the through-opening 123 to the outside. The thread 223 has been placed radially in the middle on the collar 125 of the bone anchor 101 and in the proximal direction on both sides on the sliding surfaces 127 . The two thread ends of the thread 123 have then been guided through the eye of the eyelet 305 . By pulling back the wire section 307 with the end eyelet 305 using the finger grip 303 of the threader 301 from the cavity 239 and the spiral-shaped groove 209, the thread 223 is on both sides over the thread seat 131 of the collar 125 through the feed-through opening 123 into the cavity 117 of the bone anchor 101 in the proximal direction, further through the cavity 239 of the hollow shaft 203 and through the first turn of the spiral groove 209 out (see FIGS. 9 to 11). Thus there is a prefabricated bone anchor system 400, as shown in FIG. 8, in which the two thread ends of the thread 223 are fixed in the receiving slot 215 of the handle 207 for further use. The described loading of the bone anchor 101 and the prefabrication of the bone anchor system 400 takes place during an assembly process in a production facility for the bone anchor system 400 .

[ 98 ] This prefabricated bone anchor system 400 can then be used for a knotted surgical technique . For this purpose, the preloaded bone anchor 101 is screwed into a prepared core hole 231 by a user using the inserter 201 in a screwing direction 235 (see FIG. 12). A model bone 221 is shown symbolically in FIG. 12 and the following figures in order to explain the functional principle of the insertion. The bone anchor 101 preloaded with the thread 223 is screwed into the core hole 231 in the model bone 221 up to the marking 219 . The first thread end 225 and the second thread end 227 of the thread 223 are then manually released by the user from the receiving slot 215 of the handle 207 of the inserter 201 and the inserter 201 is pulled upwards in a pulling direction 233 out of the bone anchor 101 screwed into the model bone 221 (FIG. 13). The first thread end 225 and the second thread end 227 run through the cavity 239 of the hollow shaft 203 until the two thread ends 225 , 227 are exposed. Afterward the thread 223 can be pulled through a soft tissue, whereby the two thread ends 225, 227 can still be manipulated in a pulling direction 233 on both sides (FIG. 14) until they are knotted with the soft tissue.

[ 99 ] A bone anchor system 100 is provided for a knotless surgical technique in which an unloaded bone anchor 101 is connected to the hollow shaft 203 of an introducer 201 as described above. A threader 301 has been pushed with its wire section 307 and the terminal eyelet 305 through the cavity 239 of the hollow shaft 203 and the cavity 117 of the bone anchor 101 through the distal terminal opening 121, so that the eyelet 305 protrudes at the distal end and the finger grip 301 rests on the outside of the spiral-shaped groove 209 on the proximal side (Figure 15) . In the case of the bone anchor system 100, the threader 301 is already prefabricated during the assembly process in production, so that it is available to the user in the bone anchor system 100, as shown in FIG.

[ 100 ] To use the bone anchor system 100 , the user then guides a thread 223 in the pulling direction 233 through the eye of the eyelet 305 ( FIG. 16 ) . The user has previously fixed the first thread end 225 intra-articularly to the soft tissue. By pulling on the finger grip 303 of the threader 301 in the pulling direction 233, the thread 223 guided through the eyelet 305 is pulled through the cavity 239 of the hollow shaft 203, with the wire section 307 and then the eyelet 305 emerging from the spiral-shaped groove 209. Since the first thread end 225 already on When the soft tissue is fixed, only the second thread end 227 is pulled out of the spiral groove 209 (see FIGS. 17 and 18). The user then screws the bone anchor 101 into the model bone 221 by rotating the inserter 201 in a direction of rotation 229, with the second thread end 227 remaining in the user's hand and moving upwards in the spiral-shaped groove 209 in a direction of rotation 237 and thus in the proximal direction, as a result of which a tension force of the thread 223 can be maintained and/or adjusted. As soon as the bone anchor 101 has been screwed into the model bone 221 up to the marking 219 of the hollow shaft 203, the user can release the second thread end 227 (FIG. 20).

[ 101 ] The inserter 201 is then pulled completely out of the inserted bone anchor 101 in the pulling direction 233, with the loose thread end 227 passing through the cavity 239 of the hollow shaft 203 in the distal direction when the inserter 201 is pulled out and then being separated at a separation 309 above the bone anchor 101 inserted into the core hole 231. The first thread end 225 leads to the fixed soft tissue (FIG. 22).

[ 102 ] The previously described application in a knotless surgical technique can also be combined with the knotted surgical technique . For this purpose, a pre-loaded bone anchor 101 is first set as described above and its thread material consisting of one thread or several threads is knotted with the soft tissue. This knotted suture material is now used with an unloaded second bone anchor 101 in a knotless surgical technique.

[ 103 ] A bone anchor 101 and bone anchor system 100 , 400 are thus provided which allow flexible loading with a knotless and / or knotted surgical technique .

reference character list

100 bone anchor system

101 Bone Anchor

103 proximal end

105 distal end

107 proximal section

109 distal section

111 distal direction

113 longitudinal central axis

115 thread

117 longitudinal bore

119 proximal terminal opening

121 distal terminal opening

123 through-opening

125 collar

127 sliding surface

129 side wall of the feed-through opening

131 thread seat

133 inside corner

135 rounding

137 rounding

139 perforation hole

141 hexagon socket profile

143 face

145 core diameter

201 consignors

203 hollow shaft

205 longitudinal direction

207 handle

209 spiral groove thread spool

External Hex Profile Section

On would take slit conical expansion

mark

model bones

Thread first thread end second thread end

direction of rotation

core hole

pulling direction

screw direction

spin direction

cavity

threader

finger grip f

eyelet

cut the wire

separation

Pre-assembled bone anchor system

Claims

Patent claims :

1. Bone anchor element (101) for introducing into a bone and/or fixing tissue to the bone (221), the bone anchor element (101) having a longitudinal central axis (113) and in a distal direction (111) a proximal end (103), a proximal section (107), a distal section (109) and a distal end (105), and the bone anchor element (101) from the proximal end ( 103) up to the distal end (105) has a continuous cavity (117) along the longitudinal central axis (113) with a proximal terminal opening (119) and a distal terminal opening (121), the proximal section (107) having a profiled projection (115) on the outside to prevent the bone anchor element (101) introduced into the bone (221) from being pulled off, the distal section (109) at least is tubular at its distal end section and has a lateral through-opening (123) at its proximal end section for the passage of a thread material (223), the through-opening (123) at a distal end of the proximal section (107) being connected to the continuous cavity (117) via a partially exposed distal-side opening of the proximal section (107), and the partially exposed distal-side opening being connected to an end face (143) of the proximal section (10 7) is surrounded at its distal end, characterized in that a collar (125) is arranged on the outside of the distal section (109) adjacent to the partially exposed distal-side opening of the proximal section (107) and/or the through-opening (123), wherein the collar (125) has at least one receiving surface (127) for at least one suture material (223) oriented obliquely to the longitudinal central axis (113), so that

46 the bone anchor element (101) can be loaded with the at least one thread material in a knotless and/or knotted manner by means of the collar (125) and/or the through-opening (123). Bone anchor element (101) according to Claim 1, characterized in that the collar (125) has a receiving surface (127) on both sides of the partially exposed distal-side opening of the proximal section (107) and at least partially on both sides of the through-opening (123) in the distal direction (111) and is oriented obliquely to the longitudinal central axis (113). Bone anchor element (101) according to Claim 1 or 2, characterized in that the collar (125) is formed from a side wall (129) of the through-opening (123) radially around the distal section (109) to an opposite side wall (129) of the through-opening (123). Bone anchor element (101) according to one of the preceding claims, characterized in that the collar (125) is connected to the end face (143) of the proximal section (107) on both sides via a curve, so that a seat (131) on both sides for the thread material (223) is formed approximately parallel to the longitudinal center axis (113) in the distal direction (111), followed by the receiving surface (127) aligned obliquely to the longitudinal center axis (113). Bone anchor element (101) according to one of the preceding claims, characterized in that the receiving surface (127) aligned obliquely to the longitudinal central axis (113) and/or the receiving surfaces (127) aligned obliquely to the longitudinal central axis (113) have an angle in a range from 20° to 80°, in particular from 30° to

47 60°, preferably from 40° to 50°, to the longitudinal central axis (113). Bone anchor element (101) according to one of the preceding claims, characterized in that the through-opening (123) has four inside corners (133) in a plan view. Bone anchor element (101) according to claim 6, characterized in that the four inner corners (133) of the through-opening (123) each have a rounding (135). Bone anchor element (101) according to any one of the preceding claims, characterized in that the distal end

(105), a distal end section of the distal section (109) and/or the distal section (109) in the distal direction (111) tapers conically and/or is rounded. Bone anchor element (101) according to one of the preceding claims, characterized in that the profiled projection is designed as a circumferential thread (115) which tapers in the distal direction (111) at the distal end of the proximal section (107). Bone anchor element (101) according to Claim 9, characterized in that a core diameter (145) of the circumferential thread (115) increases counter to the distal direction (111) towards the proximal end (103) of the proximal section (107). Bone anchor element (101) one of the preceding claims, characterized in that the proximal portion (107) has a plurality of perforation holes (139) which are axially symmetrical to each other to the

48 Longitudinal central axis (113) and / or in the distal direction (111) are arranged offset. Bone anchor element (101) one of the preceding claims, characterized in that the proximal terminal opening (119) and / or the proximal portion (107) has an internal carrier profile, in particular a hexagon socket profile (141). Insertion instrument (201) for inserting a

Bone anchor element (101) in a drill hole (231) in a bone (221), wherein the insertion instrument (201) has a tool shank (203) in a longitudinal direction (205), a handle (207) is arranged on a proximal end of the tool shank (203) and a driver profile (213) for connection to the bone anchor element (101) is arranged in an opposite, distal end section, and the tool shank (203) has a through cavity (239) in the longitudinal direction, characterized in that the tool shank (203) has at its proximal portion a helical indentation (209) along the longitudinal direction (205), the helical indentation (209) being connected to the through cavity (239), so that in the case of connecting the insertion instrument (201) to the bone anchor element (101), a thread material (223) by means of the helical indentation (209) in the through cavity ( 239) can be inserted or guided out of the continuous cavity (239) and/or can be tightened by rotating the insertion instrument (201). Insertion instrument (201) according to Claim 14, characterized in that the driver profile has an external driver profile, in particular an external hexagonal profile (213), for connection to the bone anchor element (101). Insertion instrument (201) according to Claim 15, characterized in that the driver profile (213) has an increasing outer diameter towards its proximal end. Insertion instrument (201) according to any one of claims 14 to

16, characterized in that the tool shank (203) has a marking (219) for a predetermined insertion depth of the bone anchor element (101). Bone anchor system (100, 400) with a bone anchor element

(101) according to one of Claims 1 to 12 and an insertion instrument (201) according to one of Claims 13 to 16, so that the insertion instrument (201) can be connected to the bone anchor element (101), a thread material

(223) can be flexibly threaded through the bone anchor element (101) and/or the bone anchor element (101) can be inserted into a drill hole (231) in a bone (221) using the insertion instrument (201). Bone anchor system (100) according to Claim 17, characterized in that the bone anchor system (100) is assigned a threader (301) with a finger grip (303) and a wire loop (305) or the bone anchor system (100) has a threader (301) with a finger grip (303) and a wire loop (305), so that when the insertion instrument (201) is connected to the bone anchor element (10 1) the wire loop (305) of the threader (301) from the outside through the spiral depression (209) into and through the cavity (239) of the tool shank (203) of the insertion instrument (201), through the continuous cavity (117) of the bone anchor element (101) to the outside of the

Through-opening (123) or can be pushed out of the terminal distal opening (121) and a thread material (223) can be threaded into the wire loop (305). Bone anchor system (400) according to claim 17 or 18, wherein the bone anchor system (100, 400) has at least one thread material (223), wherein the insertion instrument (201) is connected to the bone anchor element (101), the thread material (223) has two thread ends (225, 227), characterized in that the thread material (223) on the outside of the collar (125) of the bone anchor element (101) is arranged, the two thread ends (225, 227) are guided through the feed-through opening (123) inwards in the proximal direction through the continuous cavity (117) of the proximal section (107) of the bone anchor element (101), the cavity (239) of the tool shank (203) of the insertion instrument (201) and through the spiral-shaped depression (209) of the insertion instrument (201) to the outside and/or on the Handle (207) of the insertion instrument (201) are attached, so that a prefabricated bone anchor system (400) is present.