Patent Description:
In procedures of spinal surgery, in particular minimally invasive surgery (MIS), it is known to use a guide wire, such as a Kirschner wire (K-wire), that is placed percutaneously through the skin to the intended position of a bone anchor in a vertebra of the vertebral column. In some cases a hole for the bone anchor is pre-drilled and a thread for the bone anchor is pre-tapped. The bone anchor which has a cannulated shank is then guided along the guide wire and finally screwed into the pedicle. Thereafter, the guide wire is removed. Such a bone anchor and procedure is known, for example, from <CIT>.

Other bone anchors are known in the art that are cannulated for guiding through a guide pin or a drill. For example, <CIT> describes a bone stabilizing system including a guide pin and a cannula forming a bone anchor, wherein the guide pin is provided with a drilling means at a forward end thereof for drilling a guide hole into a fractured bone at a predetermined location. The use of the system includes the steps of inserting the guide pin into bone, placing the cannula over the guide pin and advance the cannula into the bone.

<CIT> describes a pedicle screw having a channel extending along a longitudinal axis of the screw. A drill extends through the channel, wherein a first end of the drill extends out of the distal opening of the channel.

<CIT> describes a surgical K-wire for guiding a bone screw comprising a longitudinal channel, wherein a closure element is formed at a distal end of the K-wire for closing-off the distal end outlet opening of the longitudinal channel of the bone screw. In some embodiments, the closure element is connected to the longitudinal channel by threads.

<CIT> describes a pedicle dart system comprising a guide pin having a pointed end, a pedicle dart fastener having a through bore sized to receive the guide pin therein, an indexed sleeve having a central bore through which the pedicle dart fastener passes, and a pedicle dart having a first tip end and a second indexed end for engaging an end of the indexed sleeve.

It is the object of the invention to provide a system of a bone anchor and an elongate instrument which has a broad range of applications and which simplifies surgical procedures, in particular MIS-procedures.

The object is solved by a system according to claim <NUM>. Further developments are given in the dependent claims.

The elongate instrument of the system may be, for example, a cutting device, a K-wire, a sensor for sensing characteristics at the implantation site or a marker or any other instrument. Each elongate instrument and the bone anchor together form a unit that can be placed on the implantation site and the surgical step associated with the elongate instrument can be carried out. After that, the instrument can be removed from the channel of the bone anchor and if necessary another type of elongate instrument may be inserted into the channel. Hence, the bone anchor can be assembled selectively with various instruments according to the specific function of the instrument needed. This provides a broad range of applications of the system.

In the case of the elongate instrument being a cutting device, the system permits to place the bone anchor with the inserted cutting device without using a K-wire, pre-drilling a hole and pre-tapping a thread. This saves time in a surgical procedure. Moreover, a cutting device with a shape and a length of the cutting portion suitable for the specific clinical situation in which the bone anchor is to be used, can be selected.

In the case of the elongate instrument being a K-wire, the system permits to place the bone anchor with the K-wire as a unit onto the bone surface and press the K-wire tip into the bone. Thereafter, the K-wire can be used as guiding means.

In the case of the elongate instrument being a marker, the bone anchor and a marker element may have a defined positional relationship relative to each other such that a position of the bone anchor may be precisely detected.

Further features and advantages will become apparent from the description of embodiments of the invention by means of the accompanying drawings.

<FIG> show an embodiment of the system of a bone anchor <NUM> and an elongate instrument in the form of a cutting device <NUM>. The bone anchor <NUM> comprises a shank <NUM> with a head <NUM> at a first end and a free second end <NUM>. The head <NUM> may have a spherically shaped outer surface portion that defines a largest outer diameter of the bone anchor <NUM>. A bone thread <NUM> may be provided on at least a portion of the outer surface of the shank <NUM>. The shank <NUM> may be slightly tapering towards the second end <NUM>. An engagement recess <NUM> for engagement with a tool, may be formed at a free end surface of the head <NUM>.

As shown more in detail in <FIG>, the bone anchor <NUM> is cannulated. It includes a channel <NUM> extending fully through the bone anchor from the head <NUM> to the second end <NUM>. The channel <NUM> is formed by a coaxial bore extending from the first end to a distance from the second end <NUM>. The bore axis defines a longitudinal axis L of the channel. In a portion adjacent to the second end <NUM> the diameter of the channel <NUM> is slightly smaller than that of the coaxial bore. An internal advancement structure in the form of an internal thread <NUM> is provided within the channel adjacent to or close to the second end <NUM>. Between the coaxial bore and the advancement structure a shoulder <NUM> may be formed. The shoulder <NUM> functions as an abutment to limit the insertion of an elongate instrument. This permits to achieve an exact positional relationship between the bone anchor <NUM> and the elongate instrument. A smallest inner diameter of the channel <NUM> in the bone anchor <NUM> is defined by the internal thread <NUM>.

In the wall of the shank <NUM>, at least one, preferably a plurality of radial openings <NUM>, shown in <FIG>, may be provided for the purpose of forming outlets for bone cement or a pharmaceutical substance to be introduced into the bone anchor <NUM>.

The elongate instrument in the form of the cutting device <NUM> is a substantially rod-shaped member that comprises a first end or rear end <NUM> (shown in <FIG>) and an opposite second or front end <NUM>. Basically, the cutting device <NUM> is formed as a cylindrical rod having a length from the rear end <NUM> to the front end <NUM> that is greater than the length of the bone anchor <NUM>. Specifically, the length of the cutting device <NUM> is such, that the cutting device <NUM> is configured to extend through the passage <NUM> of the bone anchor <NUM> and project out of the second end <NUM> of the bone anchor <NUM> on one side and is configured to extend through an instrument <NUM> (shown in <FIG>) for inserting the bone anchor such that the rear end <NUM> projects out of the instrument <NUM>.

Adjacent to the front end <NUM>, a tip portion <NUM> is provided that comprises a cutting edge <NUM>. For example, the cutting edge <NUM> may be formed by a recess in the outer surface of the tip portion <NUM> wherein at least one edge of the recess is configured to perform a cutting function. Although one cutting edge <NUM> is shown in the figures, a plurality of cutting edges may be provided. The shape of the cutting edge or the cutting edges, respectively, may be straight and the cutting edge <NUM> may extend in longitudinal direction or may be helical or may have any other shape that is configured to cut bone. Adjacent to or at a distance from the tip portion <NUM>, the cutting device <NUM> comprises a section with an external advancement structure in the form of an external thread <NUM> that is configured to cooperate with the internal thread <NUM> of the bone anchor <NUM>. The axial length of the section with the external thread <NUM> may be greater than or equal to the length of the section with the internal thread <NUM> of the bone anchor <NUM> so that, when the cutting device <NUM> is inserted in the passage <NUM> of the bone anchor <NUM>, the position of the cutting device <NUM> can be precisely adjusted over a certain range. Following the section with the external thread <NUM>, a small neck portion <NUM> may be provided. The remainder or main portion <NUM> of the cutting device can be formed as a cylindrical rod with a smooth surface an outer diameter of which is slightly smaller than an inner diameter of the coaxial bore of the passage <NUM> so that the cutting device <NUM> can slide within the coaxial bore.

Moreover, the cutting device <NUM> may have at a position on the main portion <NUM> that is located outside from the bone anchor <NUM> when the cutting device is inserted into the channel <NUM>, an engagement structure (not shown) for engagement with a portion of the instrument <NUM>. Such an engagement portion aims at rotationally fixing the cutting device <NUM> relative to the bone anchor <NUM> when the cutting device <NUM> has been inserted into the bone anchor and the tip portion <NUM> extends out of the first end <NUM> of the bone anchor <NUM>.

The bone anchor <NUM> and the cutting device <NUM> may each be made of a bio-compatible material, for example of titanium or stainless steel, of a bio-compatible alloy, such as NiTi-alloys, for example Nitinol, of magnesium or magnesium alloys, or from a bio-compatible plastic material, such as, for example, polyether ether ketone (PEEK) or poly-l-lactide acid (PLLA). In addition, the parts can be made of the same or of different materials from one another.

For assembly, the bone anchor <NUM> may be held by the instrument <NUM> and the cutting device <NUM> is inserted into the channel <NUM> of the bone anchor <NUM> in such a manner that by means of the cooperating threads <NUM>, <NUM>, the length of the cutting device, respectively the cutting portion <NUM>, that protrudes out of the second end <NUM> of the bone anchor <NUM> is adjusted. It shall be noted that the cutting device <NUM> and the bone anchor <NUM> could also be pre-assembled and then gripped with an instrument. By selecting the type of cutting device <NUM>, i.e. in terms of the shape of the cutting edge <NUM> and the length of the tip portion <NUM> and by adjusting the length of the portion protruding out from the second end <NUM> of the bone anchor <NUM> with the threads, it is possible to provide a system adapted to a specific requirement at the implantation site. Finally, the cutting device <NUM> is axially fixed to the bone anchor by means of the threads <NUM>, <NUM> and rotationally fixed through the cooperating engagement portions (not shown) of the cutting device <NUM> and the instrument <NUM>. Hence, the bone anchor <NUM> and the cutting device <NUM> are configured to be inserted as a unit into the bone.

Turning now to <FIG>, the bone anchor <NUM> with the cutting device <NUM> and a portion of the instrument <NUM> is shown. The instrument <NUM> is shown as an exemplary embodiment. It comprises a first head engagement portion <NUM> that engages the head <NUM> from the outside thereof and a second head engagement portion <NUM> that engages the head <NUM> in the recess <NUM> and a clamping sleeve <NUM> that presses the first head engagement portion <NUM> towards the head <NUM> so that the head <NUM> of the bone anchor <NUM> is firmly clamped in the instrument. The second head engagement portion <NUM> comprises a passage for passing through the cutting device <NUM>. As shown in <FIG>, the unit consisting of bone anchor <NUM> and cutting device <NUM>, is placed to the position where the bone anchor <NUM> is to be inserted, for example the pedicle of a vertebra <NUM>. The cutting edge <NUM> is used for penetrating the cortical bone. Hence, the tip portion <NUM> prepares the pathway for the bone anchor <NUM> so that the bone anchor <NUM> can be easily screwed in. Pre-drilling of a hole can be omitted.

Then, as shown in <FIG>, the bone anchor <NUM> is screwed into the pedicle until the shank <NUM> is finally implanted and the head <NUM> projects out of the bone surface. The placement of the bone anchor <NUM> with the cutting device <NUM> may be carried out with the assistance of an imaging method.

When the bone anchor is in the final position, the cutting device <NUM> is screwed back and removed from the bone anchor as shown in Fig. 6a. If necessary, the second end <NUM> can be closed by inserting a plug member and/or bone cement or another substance can be injected which may flow out of the openings <NUM>.

<FIG> depicts the bone anchor <NUM> and various elongate instruments. Such instruments may comprise, for example, the cutting device <NUM>, a medical guide wire <NUM>, such as a modified K-wire, a sensor <NUM> and a marker <NUM>. Each of the instruments together with the bone anchor <NUM> forms a unit. The various instruments and the bone anchor may form a modular system that permits to selectively combine one elongate instrument with the bone anchor <NUM> depending on the intended use.

The elongate instrument in the form of a medical guide wire <NUM>, such as a modified K-wire, is shown more in detail in <FIG>. The guide wire <NUM> has a substantially smooth outer surface with an outer diameter slightly smaller than an inner diameter of the thread <NUM> so that the guide wire <NUM> can be guided through the channel <NUM> of the bone anchor <NUM>. As usual, the guide wire <NUM> has a tip portion <NUM> that is configured to be pressed into bone. At a distance from the tip portion <NUM>, an external advancement structure in the form of an external thread <NUM> is provided that is configured to cooperate with the internal thread <NUM> of the bone anchor <NUM>. Preferably, an axial length of the external thread <NUM> is smaller than an axial length of the internal thread <NUM>. More in detail, the axial length of the external thread <NUM> comprises only as many thread turns as are necessary to axially secure the guide wire <NUM> against sliding in the channel <NUM>. This may be at least one or only a small number of thread turns. The external thread <NUM> may be located at such a position away from the tip portion <NUM> that the tip portion <NUM> and preferably a portion <NUM> adjacent to the tip portion <NUM> projects out of the second end <NUM>, when the external thread <NUM> engages the internal thread <NUM>.

In use, the guide wire <NUM> and the bone anchor <NUM> are assembled by screwing the guide wire <NUM> into the bone anchor <NUM> and the system is placed as a unit onto the bone surface so that the tip portion <NUM> of the guide wire is pressed into the bone. Thereafter, the bone anchor <NUM> can be screwed down until the threads are out of engagement. In this condition, the guide wire can be used as usual guide wire and the bone anchor <NUM> and other parts may be guided along the guide wire towards the implantation site. Or, the bone anchor and the modified K-wire can be placed as a unit onto the bone surface, the K-wire can be pressed into the bone and screwed further down along the internal thread.

The elongate instrument in the form of a sensor <NUM> is shown in <FIG>. As shown in <FIG>, the sensor <NUM> comprises a housing <NUM> which is substantially tube-shaped and that is configured to be passed through the channel <NUM> of the bone anchor <NUM>. The housing <NUM> has a tip portion <NUM> that may extend through the second end <NUM>. Adjacent to the tip portion <NUM>, the housing <NUM> comprises an advancement structure in the form of an external thread <NUM> that is configured to cooperate with the internal thread <NUM> of the bone anchor <NUM>. The axial length of the external thread <NUM> may be greater than or equal to the axial length of the internal thread <NUM>. Adjacent to the external thread <NUM>, a neck portion <NUM> may be present that is followed by a main portion <NUM> of the housing <NUM> with a smooth outer surface. A sensor element <NUM> is positioned in the housing <NUM>, wherein the sensor element <NUM> comprises a tip portion <NUM> that is configured to sense the respective characteristics, such as, for example, the density of the bone, or which is configured to perform neuro-monitoring. Any other suitable sensor element may be conceivable.

The sensor <NUM> may be inserted when the bone anchor has been already inserted into the bone or may be preassembled with the bone anchor <NUM> and inserted together with the bone anchor <NUM> into the bone.

An elongate instrument in the form of a marker <NUM>, such as a marker for detection through X-rays and/or marking a location on the bone, is shown more in detail in <FIG>. The marker <NUM> is substantially rod-shaped with an inner diameter that is slightly smaller than the inner diameter of the coaxial bore of the bone anchor <NUM>. A tip portion <NUM> is provided which comprises a marker element <NUM>, for example an X-ray detectable element. At a distance from the tip portion <NUM>, an external advancement structure in the form of an external thread <NUM> is provided that is configured to cooperate with the internal thread <NUM> of the bone anchor <NUM>. The axial length of the external thread <NUM> may be smaller or equal to the axial length of the internal thread <NUM>. A shoulder <NUM> that may be adjacent to the external thread <NUM> is configured to abut against the shoulder or step <NUM> in the channel <NUM> to limit the insertion of the marker <NUM> into the bone anchor. The shoulder <NUM> is located at such a position that when the shoulder <NUM> abuts against the shoulder <NUM>, the marker element is positioned at the second end <NUM> and may slightly project out of the second end <NUM>. By means of the stop provided by the shoulder <NUM>, the position of the marker <NUM> relative to the bone anchor <NUM> is defined. Therefore, the marker <NUM> can precisely indicate the position of the bone anchor <NUM>.

In use, preferably the marker <NUM> and the bone anchor <NUM> may be preassembled and inserted into the bone.

Further modifications of the above-described system may be conceivable. The shape of the bone anchor is not restricted to the shape shown in the embodiment. Any kind of bone anchor may be used, such as for example bone anchors without a bone thread, such as bone nails. The head of the bone anchor is shown to be spherically-shaped. However, any other suitable head may be conceivable. In particular, receiving parts for providing a polyaxial bone anchor may be attached to the head.

The channel of the bone anchor can have a shape other than cylindrical. The openings in the wall of the bone anchor can have any shape, in particular a longitudinally extending slit is also conceivable. Finally, the openings can be omitted.

The advancement structure is shown to be a thread, however, a plurality of concentric ribs to form an advancement structure or another advancement structure that permits to continuously or incrementally advance the cutting device within the channel may be used.

Claim 1:
A system of a bone anchor and an elongate instrument including
a bone anchor (<NUM>) comprising a shank (<NUM>) having a first end (<NUM>) and a second end (<NUM>) and a channel (<NUM>) extending through the shank (<NUM>) from the first end (<NUM>) to the second end (<NUM>), the channel (<NUM>) defining a channel axis (L);
wherein at or close to the second end (<NUM>) of the shank (<NUM>) an internal advancement structure (<NUM>) is provided at an inner wall of the channel (<NUM>); and
an elongate instrument (<NUM>, <NUM>, <NUM>, <NUM>) that is configured to extend through the channel (<NUM>);
wherein the elongate instrument (<NUM>, <NUM>, <NUM>, <NUM>) comprises a tip portion (<NUM>, <NUM>, <NUM>, <NUM>) and an external advancement structure (<NUM>, <NUM>, <NUM>, <NUM>) that cooperates with the internal advancement structure (<NUM>) of the shank (<NUM>) so as to permit the tip portion (<NUM>, <NUM>, <NUM>, <NUM>) to be advanced in the channel (<NUM>) in the direction towards the second end (<NUM>) and to be moved back in the opposite direction towards the first end (<NUM>), wherein the internal advancement structure (<NUM>) is an internal thread and the external advancement structure (<NUM>, <NUM>, <NUM>, <NUM>) is an external thread;
wherein the elongate instrument with the tip portion (<NUM>, <NUM>, <NUM>, <NUM>) is removable from the channel (<NUM>) and wherein the tip portion (<NUM>, <NUM>, <NUM>, <NUM>) is configured to be advanced in the channel (<NUM>) from the first end (<NUM>) up to the second end (<NUM>).