DE102022101556A1 - Bone anchor element for insertion into a bone and/or fixing of tissue to the bone, insertion instrument and bone anchor system - Google Patents

Abstract

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 central axis and, in a distal direction, a proximal end, a proximal section, a distal section and a distal end, from the proximal end to towards the distal end has a continuous cavity along the longitudinal central axis with a proximal end opening and a distal end opening and at its proximal end section laterally a through-opening for the passage of a thread material, with a partially exposed distal-side opening of the proximal section from an end face of the proximal section is surrounded at its distal end, with a collar being arranged on the outside of the distal section adjacent to the partially exposed distal-side opening of the proximal section and/or the through-opening, the collar having at least one receiving surface for at least one suture material, which is oriented obliquely to the longitudinal central axis, so that the Bone anchor element can be loaded with the at least one thread material in a knotless and/or knotted manner by means of the collar and/or the through-opening. Furthermore, the invention relates to an insertion instrument and a bone anchor system.

Description

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 central axis and, in a distal direction, a proximal end, a proximal section, a distal section and a distal end, and the bone anchor element from the proximal end to the distal end having a continuous cavity along the longitudinal central axis with a proximal terminal opening and a distal terminal opening, the proximal section having a profiled projection on the outside to prevent the bone anchor element introduced into the bone, the distal section is tubular at least at its distal end section and has a feed-through opening at the side on its proximal end section for the passage of a suture material, the feed-through opening at a distal end of the proximal section being connected to the continuous cavity via a partially exposed distal-side opening of the proximal section, and the partially exposed distal-side opening being surrounded by an end face of the proximal section at the distal end.

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. 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.

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 torn soft tissue is then brought to its original position with this thread material and then knotted. With 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.

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 anchor families on the market to cover both knotted and knotless surgical techniques. It must therefore always be checked during an operation whether the bone anchor model available in each case has the optimal design for the intended surgical technique, or it must be switched between different models of bone anchors at short notice.

From the document US 5,690,676A discloses a suture anchor and drive assembly, the suture anchor having a rounded or pointed head at its distal end and an elongate proximal portion with ribs for engaging bone, and proximal of the head having a through hole for passing a suture. Both the suture anchor and associated driver with a handle and long shaft may each have suture-receiving grooves to prevent the suture from interfering with the insertion of the suture anchor. This anchor is designed for the knotted surgical technique, in which the suture anchor preloaded with the thread is placed in the bone and the thread is then passed through the soft tissue and knotted.

In the US 2012/0053629 A1 describes a knotless suture anchor having a smooth distal nose and a tubular body, the suture anchor having a lateral passage for passing a suture into the lumen of the tubular body and out through its distal opening. Likewise, the loop of a threader can be pushed through this lateral opening. To this end, the associated introducer has a proximal slot for inserting the loop of the threader into the hollow shaft of the inserter, with the loop being guided outwards again via a ramp of the inserter through a distal slot before it enters the lateral passage of the suture anchor. A preloaded suture anchor for a knotted surgical technique is disclosed in US Pat US 2012/0053629 A1 not revealed.

Another knotless labral anchor is in the US 9,867,607 B2 described, which has a cannulated cavity for passing a suture, wherein the anchor is connected proximally to a driver which has a slot at its distal end for passing the suture. The thread end guided outwards through this slit has a loop of a thread-threading instrument penetrating it on the outside. This end of the suture is then passed through soft tissue and stretched using the loop of the suture-threading instrument, wäh 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.

Also the WO 2017/106608 A2 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 thread into its cavity and for guiding it through the distal opening of the anchor element. Likewise, the eyelet of a threader can be pushed through this slot past the distal end of the anchor implant to catch a suture and withdrawn.

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

The object of the invention is to improve the prior art.

The object is achieved by a bone anchor element for introducing into a bone and/or fixing tissue on the bone, wherein the bone anchor element has a longitudinal central axis and in a distal direction a proximal end, a proximal section, a distal section and a distal end, and the bone anchor element has a continuous cavity along the longitudinal central axis with a proximal terminal opening and a distal terminal opening from the proximal end to the distal end, the proximal section having a profiled projection on the outside to prevent a pulling off the bone anchor element introduced into the bone, the distal section is tubular at least at one of its distal end sections and has a through-opening on its proximal end section for passing through a suture material, the through-opening at a distal end of the proximal section being connected to the continuous cavity via a partially exposed distal-side opening of the proximal section, and the partially exposed distal-side opening being 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, wherein the collar has 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.

A bone anchor element is thus provided which can be used multifunctionally in the knotted and/or knotless surgical technique. Because of 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.

Thus, the bone anchor element can be used for various shoulder indications, such as reconstruction of the rotator cuff, biceps tenodesis, reconstruction of the deltoid muscle, reconstruction of Bankart lesions, reconstruction of SLAP lesions, correction of the acromioclavicular joint rupture, capsule displacements and/or capsulolabral reconstructions.

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.

By means of the collar with its at least one receiving surface and/or the 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. Due to 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.

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.

An essential idea of the invention is based on providing a bone anchor element which is both at its distal portion a through-opening and a collar on the outside with at least one obliquely aligned receiving surface for the thread material, the obliquely aligned receiving surface enabling targeted guidance and sliding of the thread material. The bone anchor element can be flexibly preloaded manually and/or with a threading aid and/or during an operation due to the continuous hollow space, the through-opening and the collar arranged on the outside.

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 for fixing soft tissue, such as ligaments, joint lips, rotator cuffs or torn capsules.

• Ein „Knochenankerelement“ (auch „Knochenanker“, „Knochenschraube“, „Fadenanker“ oder „Interferenzschraube“ genannt) ist insbesondere ein Element zum Einbringen in einen Knochen und/oder Fixieren von Gewebe, insbesondere abgelöstes Gewebe, an dem Knochen. Somit ist ein Knochenanker insbesondere ein Implantat zur anatomischen Fixation. Der Knochenanker weist insbesondere einen proximalen Abschnitt und einen distalen Abschnitt auf. Das Knochenankerelement mit beiden Abschnitten kann einstückig ausgebildet sein oder die zweiteilig ausgebildeten Abschnitte sind fest miteinander verbunden. Das Knochenankerelement weist insbesondere ein biointegrierbares Material auf. Das Knochenankerelement kann beispielsweise Kunststoff, wie Polyetheretherketon (PEEK), aufweisen. Das Material des Knochenankerelementes ist insbesondere röntgentransparent und sicher in der MRI(Magnetresonanztomographie). Das Knochenankerelement in dem erfindungsgemäßen einheitlichen Design kann insbesondere in verschiedenen Ankergrößen bereitgestellt werden. Die verschiedenen Größenvarianten unterscheiden sich prinzipiell nicht im Design, der Operationstechnik, Anwendung und/oder Beladungseigenschaft.

The following terms are explained:

• 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. A bone anchor is therefore in particular an implant for anatomical fixation. In particular, the bone anchor has a proximal section and a distal section. The bone anchor element with both sections can be formed in one piece or the two-part sections are firmly connected to one another. In particular, the bone anchor element has a biointegrable material. The bone anchor element can have plastic, such as polyetheretherketone (PEEK), for example. The material of the bone anchor element is, in particular, transparent to X-rays and safe 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.

“Proximal” is understood to mean the end of an object, such as the bone anchor element or an inserter, which is in the direction of the body of the user and/or surgeon. Correspondingly, the respective "distal end" or "distal section" is understood to mean 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 operator.

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

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, the proximal section can also have an oval, triangular, quadrangular or polygonal cross section. At its proximal end, the proximal section has, in particular, the proximal end opening, which in the interior borders on 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.

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 cavity 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, thereby enabling blood to circulate after implantation.

In particular, the proximal section has a profiled projection or a plurality of profiled projections on its outside. A "profiled protrusion" is, for example, a rib or multiple ribs. The rib or 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 preferably starts at the proximal end of the proximal section on the outside with a flat threaded section and also ends flush with a flat threaded section at the distal end of the proximal section. Depending on the design of the profiled projection, the bone anchor element can be anchored by turning and/or driving it into the bone.

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 tubular. If the distal section is tubular, it does not necessarily have to have a circular cross section, but can also have an oval, triangular, quadrangular and/or polygonal cross section. The distal section has, in particular in its side wall, a through-opening which is connected to the cavity of the proximal section on the proximal side and to the cavity of the distal section on the distal side as far as the opening at the distal end. Because the feed-through opening at least partially exposes the distal end of the proximal section, there is a partially exposed distal opening of the proximal section, 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 is in particular directly adjacent to 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 that is aligned obliquely to the longitudinal center axis, or a receiving surface that is aligned obliquely to the longitudinal center axis on both sides. The collar is preferably formed 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.

“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 on the outside of the through-opening. In this case, the collar can be arranged directly or at a distance from the opposite side walls of the through-opening.

A “feed-through opening” is understood to mean, in particular, a continuous opening through a side wall of the distal section. The through-opening can in particular be a hole transverse to the longitudinal central axis of the bone anchor element in the distal section. In particular, the through-opening has a dimension parallel to the longitudinal center axis and a transverse dimension transverse to the longitudinal center axis of the bone anchor element. The through-opening ends transversely to the longitudinal center axis of the bone anchor, in particular in front of the longitudinal center axis.

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

“Loadable without knots” is understood in particular to mean that the bone anchor element is unloaded, the suture material is first guided through a torn soft tissue and then fixed in the bone with the unloaded bone anchor element. “Loadable knotted” is understood in particular to mean that the bone anchor element is first preloaded with a suture material and is thus preloaded and/or prefabricated and placed in the bone. The torn soft tissue is then brought into its original position with the thread or threads attached to the bone anchor element and knotted.

In a further embodiment of the bone anchor element, the collar has a receiving surface aligned obliquely to the longitudinal center axis on both sides of the partially exposed distal-side opening of the proximal section and at least partially on both sides of the through-opening in the distal direction.

The receiving surfaces in the distal region of the bone anchor element, which are oriented obliquely on both sides to the longitudinal central axis, serve as a sliding surface for pre-loaded threads 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.

In addition, the sloping collar with its sloping receiving and sliding surfaces on both sides protects the pre-loaded sutures from damage when inserting the bone anchor element 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 rest 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.

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 on the outside around the distal section up to an opposite side wall of the through-opening.

A thread can thus be guided centrally around the partially radially circumferential collar and with its two thread ends through the 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.

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 the suture material is seated on both sides approximately parallel to the longitudinal center axis in the distal direction, followed by the receiving surface oriented obliquely to the longitudinal center axis.

Thus, the double-sided rounding in the transition area between the end face and the collar provides a defined support surface and thus a seat for the thread material on both sides, whereby the thread ends are held and guided by the respective seat and can be guided through the 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.

“Approximately parallel to the longitudinal center axis” is understood in particular to mean that the main orientation of the seat surface is essentially parallel to the longitudinal center axis. However, since the seat is rounded 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 central axis.

In order to provide a defined, oblique receiving surface and then to form the collar in the distal direction at the end of the respective oblique receiving surface, partially radially circumferentially as a connection between the two oblique receiving surfaces, the receiving surface oriented obliquely to the longitudinal central axis and/or the receiving surfaces oriented obliquely to the longitudinal central axis have an angle in a range of 20° to 80°, in particular from 30° to 60°, preferably from 40° to 50°, to the longitudinal central axis.

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.

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

An “internal corner” is understood in particular to mean that the angle of the corner is less than 180° when viewed from the inside. In particular, the inside corner is a point at which two side walls of the distal section, which adjoin the inside feed-through opening, meet.

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 are each rounded.

As a result, the feed-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 inner corner prevents damage and wear when moving and manipulating the threads.

“Rounding” is understood in particular to mean that the respective inside corner is not angular and/or designed with an acute angle, but rather as a rounding with a partial radius.

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 and/or is rounded off in the distal direction.

The fact that the distal end of the bone anchor element is tapered and/or rounded off enables the bone anchor element to be optimally inserted into the prepared core hole in the bone and/or into the joint and prevents injury to the patient and/or damage to the bone anchor element during insertion. Due to the fact that the distal end section of the tubular distal section tapers conically in the distal direction, the bone anchor element is self-centering when it is introduced into the core hole, as a result of which the introduction is simplified and the operation time can be shortened.

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 tapers in the distal direction at the distal end of the proximal section.

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.

In a further 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.

Since the core diameter of the circumferential thread is cylindrical in the distal and central area of the proximal section and increases towards the proximal end, the compression of the bone is increased during insertion at the proximal end, resulting in better fixation in the cortical bone of the bone.

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.

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 with respect to the longitudinal central axis and/or offset in the distal direction.

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 arranged at an angle of four times 90°, spaced apart 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, healing of the bone anchor element in the bone is accelerated uniformly at the same time by the perforation holes that are offset from one another and formed circumferentially along the longitudinal center axis.

In a further embodiment of the bone anchor element, the proximal terminal opening and/or the proximal section has an internal driver profile, in particular a hexagon socket profile.

An inserter (also called a driver) can be connected to the bone anchor element via the internal driver profile for inserting the bone anchor element into the drilled hole in the bone.

The necessary axial force and/or torque can thus be applied to the inserter and transmitted to the bone anchor element for screwing and/or driving into the bone via the internal driver profile. The internal entrainment profile is guided in particular 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 forming 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.

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

Thus, after attaching and/or connecting an insertion instrument to and/or in the bone anchor element, the bone becomes twisted anchor element relative to the insertion element, for example during screwing into the bone, prevented. In addition, it can thereby be ensured that the bone anchor element is connected to the insertion instrument in a defined alignment and thus the wire loop of a threader can always be pushed through the through-opening in a targeted manner on the same side of the distal section.

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 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 cavity in the longitudinal direction, the tool shank having a spiral-shaped depression along the longitudinal direction on its proximal section, the spiral-shaped depression having the continuous cavity is connected, 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 depression or can be guided out of the continuous cavity and/or can be tensioned by rotating the insertion instrument.

Thus, an insertion instrument is provided with which a previously described bone anchor element can be inserted into a drill hole within a bone after connecting the distal end of the inserter to the proximal section of the bone anchor element and can be anchored there by hammering and/or screwing.

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. Thus, during insertion, the tension of the thread is maintained, adjusted and/or can be adjusted in a targeted manner. This prevents the thread from wrapping around the shaft of the inserter when the bone anchor is being screwed in, avoiding undesired tension and having to be unwound manually by the user before the thread can be used further.

A “insert instrument” (also called “insert device”) 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 disposed of after it has been used. The insertion instrument is therefore in particular a sterile single-use product.

The inserter's tool shank 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 helical depression. The length of the tool shank and/or the spiral-shaped indentation 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.

A "spiral depression" (also called spiral groove) is in particular a recess in the longitudinal direction of the tool shank in the area of its proximal and/or distal section, the recess going through from the outside into the interior cavity of the tool shank. The helical depression is in particular formed spirally wound in the longitudinal direction around and/or in the tool shank.

“Longitudinally” means the direction of the longest extension and/or dimension of the insertion instrument. Thus, the longitudinal direction is in particular also the direction in which the bone anchor element is introduced into a bone.

A "bore hole" (also called "core hole") is a hole made in the bone by drilling, hammering, or in some other way.

In a further 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.

As a result, an optimal connection and force transmission of the insertion instrument to an internal driver profile, in particular a hexagon socket profile, of the bone anchor element can be achieved by means of the external driver profile. Here, the internal driver profile of the bone anchor element and the external 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.

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 is prevented from twisting.

This ensures that both the spiral-shaped 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.

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

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.

In a further embodiment of the insertion instrument, the tool shank has a marking for a predetermined insertion depth of the bone anchor element.

The maximum insertion depth is indicated to the user directly when screwing in the bone anchor element by means of the marking, for example a circumferential laser marking.

In a further embodiment of the insertion instrument, the handle has a recess and/or a spool for receiving a thread material.

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 to the side of the handle in the longitudinal direction to the proximal end. The spool for winding up protruding suture material is preferably formed at the proximal end of the handle.

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.

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.

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 projects from the outside through the spiral-shaped depression into and through the cavity of the tool shaft of the insertion instrument, through the continuous cavity of the bone anchor element to the outside of the through-opening or out of the terminal distal opening bbar and a thread material can be threaded into the wire loop.

A bone anchor system with an unloaded bone anchor element is thus provided for a knotless surgical technique in which the bone anchor element is loaded with the suture during the operation.

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 eyelet. A wire loop can in particular be one that is bent into a loop Act loading wire. A wire loop is also understood to mean a suture thread bent into a loop. The wire loop is designed in particular at the end of a bent-back wire or suture, the two ends of the wire or suture being held together by the threader, attached to it or otherwise held together, for example manually. To hold the threader (also called a threading aid or pull-in aid), it has a finger grip, particularly at its proximal end.

Thus, in a knotless surgical technique using the threader as a pulling aid, a suture material accommodated in the wire loop of the threader can be guided through the bone anchor element and the hollow tool shank of the insertion instrument, with the thread then emerging from the helical groove. This subsequent loading of the bone anchor element usually takes place outside of the joint and/or bone.

In order to also implement a knotted surgical technique with a preloaded 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 inward in the proximal direction through the continuous cavity of the proximal section of the bone anchor element, the cavity of the tool shaft of the insertion instrument and through the spiral depression of the insertion instruments are led to the outside and/or attached to the handle of the insertion instrument, so that there is a prefabricated bone anchor system.

A flexible, adaptable bone anchor system is thus provided, with which the reattachment of soft tissue can be implemented 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.

• - Verbinden des distalen Endes des Einbringinstrumentes mit dem proximalen Ende des Knochenankerelementes,
• - Einführen einer Drahtschlinge eines Einfädlers von außen in die spiralförmige Vertiefung in den Hohlraum des Werkzeugschafts des Einbringinstrumentes,
• - Durchschieben der Drahtschlinge durch den Hohlraum des Werkzeugschafts des Einbringinstrumentes und durch den durchgehenden Hohlraum des Knochenankerelementes bis nach außen aus der Durchführöffnung oder aus der endständigen distalen Öffnung des distalen Abschnittes des Knochenankerelementes,
• - Einfädeln eines Nahtfadens des Nahtmaterials durch die Drahtschlinge,
• - Zurückziehen des Einfädlers aus der spiralförmigen Vertiefung, sodass die Drahtschlinge in einer proximalen Richtung durch den durchgehenden Hohlraum des Knochenankerelementes und dem Hohlraum des Werkzeugschafts des Einbringinstrumentes geführt wird,
• - Herausziehen des Einfädlers mit der Drahtschlinge aus der spiralförmigen Vertiefung, sodass mindestens ein Fadenende am Handgriff des Einbringinstrumentes befestigbar und/oder vom Benutzer haltbar ist.

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,
• - inserting 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 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 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 recess 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,
• - Pulling out the threader with the wire loop from 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.

• - Verbinden des distalen Endes des Einbringinstrumentes mit dem proximalen Ende des Knochenankerelementes,
• - Einführen einer Drahtschlinge eines Einfädlers von außen durch die spiralförmige Vertiefung in den Hohlraum des Werkzeugschafts des Einbringinstrumentes,
• - Durchschieben der Drahtschlinge durch den Hohlraum des Werkzeugschaftes des Einbringinstrumentes und durch den durchgehenden Hohlraum des Knochenankerelementes bis nach außen aus der Durchführöffnung,

• - Legen eines Nahtfadens um den Kragen des distalen Abschnittes des Knochenankerelementes, sodass die beiden Fadenenden zu einer proximalen Richtung ausgerichtet sind,
• - Durchführen der beiden Fadenenden durch ein Auge der Drahtschlinge,
• - Zurückziehen des Einfädlers aus der spiralförmigen Vertiefung, sodass die Drahtschlinge mit den eingefädelten beiden Fadenenden durch den durchgehenden Hohlraum des Knochenankerelementes und den Hohlraum des Werkzeugschaftes des Einbringinstrumentes in proximaler Richtung gezogen wird,
• - Ziehen der beiden Fadenenden aus der spiralförmigen Vertiefung des Werkzeugschafts des Einbringinstrumentes, und
• - Festhalten oder Befestigen der beiden Enden des Nahtfadens an dem Handgriff des Einbringers, sodass das Knochenankersystem vorkonfektioniert und beladen in einer geknoteten Operationstechnik einsetzbar ist.

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:

• - connecting the distal end of the insertion instrument to the proximal end of the bone anchor element,
• - inserting a wire loop of a threader from the outside through the spiral depression 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 of 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 depression so that the wire loop with the two thread ends threaded through is pulled in the proximal direction through the continuous cavity of the bone anchor element and the cavity of the tool shaft of the insertion instrument,
• - 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.

• 1 eine perspektivische Darstellung eines Knochenankers in einer seitlichen Draufsicht von oben,
• 2 eine perspektivische Darstellung des Knochenankers aus 1 in Seitenansicht,
• 3 eine perspektivische Darstellung des Knochenankers aus 1 in einer Draufsicht,
• 4 eine perspektivische Darstellung eines distalen Endes des Knochenankers in einer Draufsicht,
• 5 eine perspektivische Darstellung eins proximalen Endes des Knochenankers in einer Draufsicht,
• 6 eine perspektivische Darstellung eines Einbringers in einer Seitenansicht,
• 7 eine perspektivische Darstellung einer Vergrößerung eines distalen Endes des Einbringers aus 6,
• 8 eine perspektivische Darstellung eines vorkonfektionierten Knochenankersystems in Seitenansicht,
• 9 eine perspektivische Darstellung einer Vergrößerung eines Handgriffs und eines proximalen Abschnittes eines Werkzeugschafts eines Einbringers des vorkonfektionierten Knochenankersystems,
• 10 einen Längsschnitt durch einen Knochenanker verbunden mit dem Werkzeugschaft des Einbringers mit einem beladenen Faden des vorkonfektionierten Knochenankersystems,
• 11 eine perspektivische Darstellung des Knochenankers mit einem um einen Kragen geführten Faden in seitlicher Draufsicht des vorkonfektionierten Knochenankersystems,
• 12 eine perspektivische Darstellung des vorkonfektionierten Knochenankersystems beim Eindrehen in einen Modellknochen,
• 13 eine perspektivische Darstellung des vorkonfektionierten Knochenankersystems beim Herausziehen des Einbringers,
• 14 eine perspektivische Darstellung des Knochenankers eingebracht in den Modellknochen,
• 15 eine perspektivische Darstellung eines Knochenankersystems mit einem Einbringer, einem Einfädler und einem Knochenanker für eine knotenlose Operationstechnik,
• 16 eine perspektivische Darstellung des distalen Abschnittes eines Werkzeugschaftes des Einbringers mit dem verbundenem Knochenanker und durchgeschobener Öse mit durchgeführtem Faden aus 15,
• 17 eine perspektivische Darstellung des Knochenankersystems aus 15 beim Rausziehen des Einfädlers aus einer spiralförmigen Nut des Hohlschaftes des Einbringers,
• 18 eine perspektivische Darstellung des Knochenankersystems aus 15 mit einem ausgetretenen Faden aus der spiralförmigen Nut des Hohlschaftes des Einbringers,
• 19 eine perspektivische Darstellung des Knochenankersystems aus 15 beim Einschrauben des Einbringers in einen Modellknochen,
• 20 eine perspektivische Darstellung des Knochenankersystems aus 15 bei einem in den Modellknochen eingeschraubten Knochenanker,
• 21 eine perspektivische Darstellung des Knochenankersystems aus 15 beim Rausziehen des Einbringers, und
• 22 eine perspektivische Darstellung des eingebrachten Knochenankers in ein Bohrloch in dem Modellknochen.

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

• 1 a perspective view of a bone anchor in a side plan view from above,
• 2 a perspective view of the bone anchor 1 in side view,
• 3 a perspective view of the bone anchor 1 in a top view,
• 4 a perspective representation of a distal end of the bone anchor in a plan view,
• 5 a perspective representation of a proximal end of the bone anchor in a plan view,
• 6 a perspective view of a consignor in a side view,
• 7 Figure 12 is a perspective view of an enlargement of a distal end of the introducer 6 ,
• 8th a perspective view of a prefabricated bone anchor system in side view,
• 9 a perspective view of an enlargement of a handle and a proximal section of a tool shank of an inserter of the prefabricated bone anchor system,
• 10 a longitudinal section through a bone anchor connected to the tool shank of the inserter with a loaded suture of the prefabricated bone anchor system,
• 11 a perspective view of the bone anchor with a thread guided around a collar in a side plan view of the prefabricated bone anchor system,
• 12 a perspective view of the prefabricated bone anchor system when screwing it into a model bone,
• 13 a perspective view of the prefabricated bone anchor system when the inserter is pulled out,
• 14 a perspective view of the bone anchor placed in the model bone,
• 15 a perspective view of a bone anchor system with an inserter, a threader and a bone anchor for a knotless surgical technique,
• 16 a perspective view of the distal portion of a tool shank of the inserter with the connected bone anchor and pushed-through eyelet with thread 15 ,
• 17 a perspective view of the bone anchor system 15 when pulling the threader out of a spiral groove in the hollow shaft of the inserter,
• 18 a perspective view of the bone anchor system 15 with a suture that has emerged from the spiral groove of the hollow shaft of the inserter,
• 19 a perspective view of the bone anchor system 15 when screwing the inserter into a model bone,
• 20 a perspective view of the bone anchor system 15 with a bone anchor screwed into the model bone,
• 21 a perspective view of the bone anchor system 15 when the consignor is pulled out, and
• 22 a perspective view of the introduced bone anchor in a drilled hole in the model bone.

A bone anchor 101 has a longitudinal central axis 113, with 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 FIG 1 until 3 ). The bone anchor 101 internally has a continuous longitudinal bore 117 from a proximal end opening 119 to a distal end opening 121 (see FIG 4 and 5 ). A continuous, circumferential thread 115 is arranged externally along the proximal section 107, which is flat with a thread valley at the proximal end 103 and at the distal end of the proximal section tes 107 ends. 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 inserting the bone anchor 101 into a bone and thereby improves fixation.

Furthermore, the proximal section 107 has a plurality of perforation holes 139 in the thread valleys, which are distributed at regular intervals over 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.

The distal section 109 of the bone anchor 101 is tubular and tapers slightly in the distal direction 111 towards the distal end 105. The distal section 109 has a rounded portion 137 around the distal opening 121 at the end. Both favor an introduction of the bone anchor 101 into a bone. In its proximal region, the distal section 109 has a 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 through-opening 123, an end face 143 of the proximal section 107 is partially exposed and the through-opening 123 is connected to the longitudinal bore 117 located on the inside. In top view ( 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.

In its proximal region, the distal section 109 has a circumferential collar 125 which has two inclined sliding surfaces 127 on both sides at an angle of 45° to the longitudinal central axis 113 . The collar 125 is formed circumferentially around the tubular area of the distal section 109 on a side opposite the 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 middle region in order to ensure a secure seat of a thread.

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

The introducer 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-shaped groove 209 along the longitudinal direction 205 in its proximal region. At the distal end of the hollow shaft 203 there is an external hexagon profile section 213 for connection to the internal hexagon profile 141 of the bone anchor 101 (see FIG 6 ). The external hexagon profile section 213 has a width across flats of 2.75 mm in cross section. 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 is designed as an all-round laser marking and indicates the maximum insertion depth when the bone anchor 101 is screwed in. The handle 207 is made of plastic and the hollow shaft 203 is made of metal.

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.

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 shaft 203 of the introducer 201 by means of its hexagon socket profile 141. To preload the bone anchor 101, an eyelet 305 with the wire section 307 of the threader 301 has been pushed from the outside through the helical 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 center on the collar 125 of the bone anchor 101 and on both sides in the proximal direction 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 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 s 203 and passed out through the first turn of the helical groove 209 (see 9 until 11 ). Thus lies a prefabricated bone anchor system 400, as in 8th shown, in which the two thread ends of the thread 223 are fixed for further use in the receiving slot 215 of the handle 207. 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 .

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-in direction 235 (see FIG 12 ). In the 12 A model bone 221 is shown symbolically in each of 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 user then manually loosens the first suture end 225 and the second suture end 227 of the suture 223 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 ( 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. The thread 223 can then be pulled through soft tissue, with the two thread ends 225, 227 still being able to be manipulated in a pulling direction 233 on both sides ( 14 ) until they are knotted to the soft tissue.

For a knotless surgical technique, a bone anchor system 100 is provided 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 hollow space 239 of the hollow shaft 203 and the hollow space 117 of the bone anchor 101 through the distal end 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 end ( 15 ). In the case of the bone anchor system 100, the threader 301 is already pre-assembled during the assembly process in production, so that it can be used in the bone anchor system 100, as shown in 15 shown, is available for the user.

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 ( 16 ). The user has previously fixed the first thread end 225 to the soft tissue intra-articularly. 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 groove 209 . Since the first suture end 225 is already fixed to the soft tissue, only the second suture end 227 is pulled out of the spiral groove 209 (see Fig 17 and 18 ). The user then screws the bone anchor 101 into the model bone 221 by turning the inserter 201 in a direction of rotation 229, with the second suture end 227 remaining in the user's hand and migrating upwards in the helical groove 209 in a direction of rotation 237 and thus in the proximal direction, as a result of which a tension force of the suture 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 second thread end 227 can be released from the user's hand ( 20 ).

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 running through the cavity 239 of the hollow shaft 203 in the distal direction when the inserter 201 is pulled out and then being able to be severed at a separation 309 above the bone anchor 101 inserted into the core hole 231. The first suture end 225 leads to the fixed soft tissue ( 22 ).

The use described above in a knotless surgical technique can also be combined with the knotted surgical technique. For this purpose, a preloaded 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.

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

Reference 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 hole

125

collar

127

sliding surface

129

side wall of the through-opening

131

thread fit

133

inside corner

135

rounding

137

rounding off

139

perforation hole

141

hexagon socket profile

143

face

145

core diameter

201

consignor

203

hollow shaft

205

longitudinal direction

207

handle

209

spiral groove

211

thread spool

213

External Hex Profile Section

215

receiving slot

217

conical expansion

219

mark

221

model bones

223

thread

225

first thread end

227

second thread end

229

direction of rotation

231

core hole

233

pulling direction

235

screw direction

237

spin direction

239

cavity

301

threader

303

finger grip

305

eyelet

307

wire section

309

separation

400

Pre-assembled bone anchor system

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• US5690676A [0005]
• US 2012/0053629 A1 [0006]
• US 9867607 B2 [0007]
• WO 2017/106608 A2 [0008]

Claims (19)

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) to the distal end (105) inside has a continuous cavity (117) along the longitudinal central axis (113) with a proximal end opening (119) and a distal end 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) being tubular at least at its distal end section and has a through-opening (123) on the side of its proximal end section for passing through 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 surrounded by an end face (143) of the proximal section (107) at its distal end ,characterizedthat 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), the collar (125) having at least one receiving surface (127) for at least one suture material (223), which is oriented obliquely to the longitudinal central axis (113), so that the bone anchor element (101) can be held in place by means of the collar (125) and/or the through-opening (123) can be loaded with the at least one thread material in a knotless and/or knotted manner. Bone anchor element (101) according to claim 1 , characterized in that the collar (125) has a receiving surface (127) aligned obliquely to the longitudinal center axis (113) 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). 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) has or have an angle in a range from 20° to 80°, in particular from 30° to 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 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) tapers conically in the distal direction (111) and/or is rounded off. 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) according to one of the preceding claims, characterized in that the proximal section (107) has a plurality of perforation holes (139) which are each arranged axially symmetrically to the longitudinal center axis (113) and/or offset in the distal direction (111). Bone anchor element (101) according to one of the preceding claims, characterized in that the proximal terminal opening (119) and/or the proximal section (107) has an internal driver profile, in particular a hexagon socket profile (141). Insertion instrument (201) for inserting a bone anchor element (101) into a drill hole (231) in a bone (221), the insertion instrument (201) having a tool shank (203) in a longitudinal direction (205), a handle (207) on a proximal end of the tool shank (203) and a driver profile (213) for connection to the bone anchor element (101) arranged in an opposite, distal end section and the tool shank (203) has a continuous cavity (239) in the longitudinal direction,characterizedthat the tool shank (203) has a helical indentation (209) along the longitudinal direction (205) on its proximal section, the helical indentation (209) being connected to the through cavity (239), so that when the insertion instrument (201) is connected to the bone anchor element (101), a thread material (223) can be inserted into or out of the through cavity (239) by means of the helical indentation (209). (239) can be brought out and/or clamped by turning the insertion instrument (201). Insertion instrument (201) according to Claim 13 , 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 14 , characterized in that the driver profile (213) has an increasing outer diameter towards its proximal end. Insertion instrument (201) according to one of Claims 14 or 15 , 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 until 12 and an insertion instrument (201) according to any one of Claims 13 until 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 , dadurch gekennzeichnet , dass dem Knochenankersystem (100) ein Einfädler (301) mit einem Fingergriff (303) und einer Drahtschlinge (305) zugeordnet ist oder das Knochenankersystem (100) einen Einfädler (301) mit einem Fingergriff (303) und einer Drahtschlinge (305) aufweist, sodass im Falle des Verbindens des Einbringinstruments (201) mit dem Knochenankerelement (101) die Drahtschlinge (305) des Einfädlers (301) von außen durch die spiralförmige Vertiefung (209) in und durch den Hohlraum (239) des Werkzeugschaftes (203) des Einbringinstruments (201), durch den durchgehenden Hohlraum (117) des Knochenankerelementes (101) bis nach außen aus der Durchführöffnung (123) oder aus der endständigen distalen Öffnung (121) hinaus schiebbar und in die Drahtschlinge (305) ein Fadenmaterial (223) einfädelbar ist. Bone anchor system (400) according to Claim 17 or 18 , wobei das Knochenankersystem (100, 400) mindestens ein Fadenmaterial (223) aufweist, wobei das Einbringinstrument (201) mit dem Knochenankerelement (101) verbunden ist, das Fadenmaterial (223) zwei Fadenenden (225, 227) aufweist, dadurch gekennzeichnet , dass das Fadenmaterial (223) außen an dem Kragen (125) des Knochenankerelementes (101) angeordnet ist, die beiden Fadenenden (225, 227) durch die Durchführöffnung (123) nach innen in proximaler Richtung durch den durchgehendenden Hohlraum (117) des proximalen Abschnittes (107) des Knochenankerelementes (101), den Hohlraum (239) des Werkzeugschaftes (203) des Einbringinstrumentes (201) und durch die spiralförmige Vertiefung (209) des Einbringinstrumentes (201) nach außen geführt sind und/oder an dem Handgriff (207) des Einbringinstrumentes (201) befestigt sind, sodass ein vorkonfektioniertes Knochenankersystem (400) vorliegt.

Images