BONE ANCHOR ELEMENT FOR INSERTING INTO A BONE AND/OR FIXING TISSUE TO THE BONE, INSERTER, BONE ANCHOR SYSTEM AND METHOD FOR ASSEMBLING A BONE ANCHOR SYSTEM

Abstract

The invention relates to a bone anchor element for inserting into a bone and/or fixing tissue to the bone, wherein the bone anchor element has in a longitudinal direction a proximal end, a proximal section, a distal section and a distal end, and the proximal section has on the outside a contoured indentation to prevent the bone anchor element inserted into the bone from being pulled out and on the inside a continuous hollow space in the longitudinal direction having a proximal opening and a distal opening, and the distal section is formed in a flattened, plate-shaped manner having a plate plane, wherein the bone anchor element has at least one transverse through-hole for receiving a suture material, and the distal section has in the longitudinal direction to the distal end a first transverse through-hole through the plate plane, wherein the first transverse through-hole is connected to the continuous hollow space of the proximal section via the distal opening, and subsequently has a second transverse through-hole through the plate plane, wherein the first transverse through-hole and the second transverse through-hole are separated by a web of the plate-shaped distal section, and the second transverse through-hole has on the distal end a gap opening in the longitudinal direction and essentially transverse to the plate plane so that the suture material can be flexibly guided through the continuous hollow space, the first transverse through-hole, the second transverse through-hole and/or the gap opening, and the web has on its proximal side in relation to the first transverse through-hole an inclined abutment surface in such a manner that in the event an eyelet is pushed through from the proximal opening through the continuous hollow space of the bone anchor element, through the distal opening and through the first transverse through-hole in the longitudinal direction, the eyelet is guided outward through the first transverse through-hole upon striking the inclined abutment surface. Furthermore, the invention relates to an inserter, a bone anchor system and a method for assembling a bone anchor system.

Claims

1. A bone anchor element for inserting into a bone and/or fixing tissue to the bone, wherein the bone anchor element has in a longitudinal direction a proximal end, a proximal section, a distal section and a distal end, and the proximal section has on the outside a contoured projection to prevent the bone anchor element inserted into the bone from being pulled out and on the inside a continuous hollow space in the longitudinal direction having a proximal opening and a distal opening, and the distal section is formed in a flattened, plate-shape manner having a plate plane, wherein the distal section in the longitudinal direction to the distal end has a first transverse through-hole through the plate plane, wherein the first transverse through-hole is connected to the continuous hollow space of the proximal section via the distal opening, and subsequently has a second transverse through-hole through the plate plane, wherein the first transverse through-hole and the second transverse through-hole are separated by a web of the plate-shaped distal section, wherein the second transverse through-hole has on the distal end a gap opening in the longitudinal direction and essentially transverse to the plate plane so that a suture material can be flexibly guided through the continuous hollow space, the first transverse through-hole, the second transverse through-hole and/or the gap opening, and the web has on its proximal side in relation to the first transverse through-hole an inclined abutment surface in such a manner that in the event an eyelet is pushed through from the proximal opening through the continuous hollow space of the bone anchor element, through the distal opening and through the first transverse through-hole in the longitudinal direction, the eyelet is guided outward upon striking the inclined abutment surface through the first transverse through.

2. The bone anchor element according to claim 1, wherein the proximal section and/or the distal section taper(s) continuously or non-continuously from the respective proximal end to the respective distal end.

3. The bone anchor element according to claim 1, wherein the first transverse through-hole through the plate plane is formed in an essentially quadrilateral manner, particularly in a rectangular manner transverse to the longitudinal direction.

4. The bone anchor element according to claim 1, wherein the second transverse through-hole through the plate plane has an essentially round shape.

5. The bone anchor element according to claim 1, wherein the distal end of the distal section is rounded about the gap opening in the plate plane and/or has after the gap opening a clearance space widening in the longitudinal direction to the distal end.

6. The bone anchor element according to claim 1, wherein a gap width of the gap opening in the plate plane is adjusted to a diameter of the suture material.

7. The bone anchor element according to claim 1, wherein the bone anchor element is designed in a one-piece manner.

8. The bone anchor element according to claim 1, wherein the bone anchor element has a biointegratable material.

9. The bone anchor element according to claim 1, wherein the proximal section has a perforation or a plurality of perforations.

10. The bone anchor element according to claim 1, wherein the proximal opening has an internal driving profile, particularly an internal hexagonal profile.

11. The bone anchor element according claim 1, wherein the bone anchor element has on its proximal end and/or at the proximal opening an anti-rotation protection element.

12. An inserter configured to insert a bone anchor element into a drill hole in a bone, wherein the bone anchor element is a bone anchor element, wherein the bone anchor element has in a longitudinal direction a proximal end, a proximal section, a distal section and a distal end and the proximal section has on the outside a contoured projection to prevent the bone anchor element inserted into the bone from being pulled out and on the inside a continuous hollow space in the longitudinal direction having a proximal opening and a distal opening, and the distal section is formed in a flattened, plate-shape manner having a plate plane, wherein the distal section in the longitudinal, direction to the distal end has a first transverse through-hole through the plate plane, wherein the first transverse through-hole is connected to the continuous hollow space of the proximal section via the distal opening, and subsequently has a second transverse through-hole through the plate plane, wherein the first transverse through-hole and the second transverse through-hole separated by a web of the plate-shaped distal section, wherein the second transverse through-hole has on the distal end a gap opening in the longitudinal direction and essentially transverse to the plate plane so that a suture material can be flexibly guided through the continuous hollow space, the first transverse through-hole, the second transverse through-hole and/or the gap opening, and the web has on its proximal side in relation to the first transverse through-hole an inclined abutment surface in such a manner that in the event an eyelet is pushed through from the proximal opening through the continuous hollow space of the bone anchor element, through the distal opening and through the first transverse through-hole in the longitudinal direction, the eyelet is guided outward upon striking the inclined abutment surface through the first transverse through-hole, and the inserter has a tool shaft in a longitudinal direction, a hand grip is arranged at a proximal end of the tool shaft and a driving profile for connecting to the bone anchor element is arranged in an opposing distal end section, and the tool shaft has in at least one region before the distal end up to and including the driving profile a continuous hollow space in the longitudinal direction, wherein the tool shaft has before the distal end an insertion opening in the longitudinal direction, wherein the insertion opening is connected to the continuous hollow space so that in the event the inserter is connected to the bone anchor element, an eyelet can be pushed from the outside through the insertion opening into the continuous hollow space all the way through the driving profile on the distal end of the inserter and through the continuous hollow space of the bone anchor element through the distal opening into the first transverse through-hole of the bone anchor element and via the inclined abutment surface outward over the distal end of the bone anchor element.

13. The inserter according to claim 12, wherein the driving profile has an external driving profile, particularly an external hexagonal profile.

14. The inserter according to claim 12, wherein the inserter has an anti-rotation protection element, so that in the event of connecting the inserter by means of the driving profile to a bone anchor element, rotation of the connected bone anchor element is prevented.

15. The inserter according to claim 12, wherein the hand grip has a recess and/or a spool for receiving a suture material.

16. A bone anchor system having a bone anchor element, wherein the bone anchor element has in a longitudinal direction a proximal end, a proximal section, a distal section and a distal end, and the proximal section has on the outside a contoured projection to prevent the bone anchor element inserted into the bone from being pulled out and on the inside a continuous hollow space in the longitudinal direction having a proximal opening and a distal opening, and the distal section is formed in a flattened, plate-shape manner having a plate plane, wherein the distal section in the longitudinal direction to the distal end has a first transverse through-hole through the plate plane, wherein the first transverse through-hole is connected to the continuous hollow space of the proximal section via the distal opening, and subsequently has a second transverse through-hole through the plate plane, wherein the first transverse through-hole and the second transverse through-hole are separated by a web of the plate-shaped distal section, wherein the second transverse through-hole has on the distal end a gap opening in the longitudinal direction and essentially transverse to the plate plane so that a suture material can be flexibly guided through the continuous hollow space, the first transverse through-hole, the second transverse through-hole and/or the gap opening, and the web has on its proximal side in relation to the first transverse through-hole an inclined abutment surface in such a manner that in the event an eyelet is pushed through from the proximal opening through the continuous hollow space of the bone anchor element, through the distal opening and through the first transverse through-hole in the longitudinal direction, the eyelet is guided outward upon striking the inclined abutment surface through the first transverse through-hole, and an inserter, so that the inserter is configured to be connected to the bone anchor element, a suture material can be flexibly threaded through the bone anchor element, and the bone anchor element can be inserted by means of the inserter into a drill hole in a bone.

17. The bone anchor system according to claim 16, wherein the bone anchor system is allocated a threader having an eyelet or the bone anchor system encompasses the threader with the eyelet so that in the event of connecting the inserter to the bone anchor element, the eyelet of the threader can be pushed from the outside through the insertion opening into and through the hollow space of the tool shaft of the inserter, through the continuous hollow space, the distal opening and the first transverse through-hole via the inclined abutment surface to the outside over the distal end of the bone anchor element and a suture material can be threaded into the eyelet.

18. The bone anchor system according to claim 16, wherein the bone anchor system encompasses the suture material.

19. A method for assembling a bone anchor system using a bone anchor element, wherein the bone anchor element has in a longitudinal direction a proximal end, a proximal section, a distal section and a distal end, and the proximal section has on the outside a contoured projection to prevent the bone anchor element inserted into the bone from being pulled out and on the inside a continuous hollow space in the longitudinal direction having a proximal opening and a distal opening, and the distal section is formed in a flattened, plate-shape manner having a plate plane, wherein the distal section in the longitudinal direction to the distal end has a first transverse through-hole through the plate plane, wherein the first transverse through-hole is connected to the continuous hollow space of the proximal section via the distal opening, and subsequently has a second transverse through-hole through the plate plane, wherein the first transverse through-hole and the second transverse through-hole are separated by a web of the plate-shaped distal section, wherein the second transverse through-hole has on the distal end a gap opening in the longitudinal direction and essentially transverse to the plate plane so that a suture material can be flexibly guided through the continuous hollow space, the first transverse through-hole, the second transverse through-hole and/or the gap opening, and the web has on its proximal side in relation to the first transverse, through-hole an inclined abutment surface in such a manner that in the event an eyelet is pushed through from the proximal opening through the continuous hollow space of the bone anchor element, through the distal opening and through the first transverse through-hole in the longitudinal direction, the eyelet guided outward upon striking the inclined abutment surface through the first transverse through-hole, and an inserter comprising: connecting the distal end of the inserter to the proximal end of the bone anchor element, inserting an eyelet of a threader from the outside through the insertion opening into the hollow space of the tool shaft of the inserter, pushing the eyelet through the hollow space of the tool shaft of the inserter and through the continuous hollow space, the distal opening and the first transverse through-hole via the inclined abutment surface to the outside over the distal end of the bone anchor element, threading a suture thread of the suture material through the eyelet, partially retracting the threader so that the eyelet is displaced toward the proximal end of the bone anchor element to the gap opening of the second transverse through-hole, threading the suture thread into the gap opening of the second transverse through-hole, further retracting the threader so that the suture thread contacts the distal side of the web, pulling a first end of the suture thread out of the eyelet and guiding the first end along an exterior side of the bone anchor element and over its proximal end, completely retracting the threader out of the insertion opening of the tool shaft so that a second end of the suture thread is pulled out of the insertion opening over the web and through the continuous hollow space of the proximal section and over the proximal end of the bone anchor element, and holding or attaching the two ends of the suture thread to the hand grip of the inserter, so that the suture thread is knotlessly attached to the bone anchor element.

Description

[0106] Hereinafter, the invention shall be explained in greater detail using embodiments. Depicted are:

[0107] FIG. 1 a perspective view of a bone screw looking at its distal end,

[0108] FIG. 2 a perspective view of the bone screw from FIG. 1 looking at its proximal end,

[0109] FIG. 3 a perspective view of an alternative of the bone screw with perforations looking at the side,

[0110] FIG. 4 a longitudinal section through the of the alternative bone screw from FIG. 3,

[0111] FIG. 5 a longitudinal section through the alternative of the bone screw from FIGS. 3 and 4 with the inserted hollow shaft of an inserter,

[0112] FIG. 6 an illustration of a conventional bone screw loaded with a thread,

[0113] FIG. 7 an illustration of a bone screw knotlessly loaded using a threader,

[0114] FIG. 8 an illustration of a bone screw loaded manually during a surgery,

[0115] FIG. 9 a perspective view of the distal end of a bone screw with an inclined abutment surface of a first loading hole,

[0116] FIG. 10 a perspective view of an inserter with a connected bone screw and inserted threader,

[0117] FIG. 11 a partially perspective view and a partially sectional view as a detail from FIG. 10,

[0118] FIG. 12 a magnified section of the bone screw from FIG. 11 with eyelet inserted,

[0119] FIG. 13 a perspective view of a distal end of an inserter with connected bone screw, inserted threader and thread,

[0120] FIG. 14 a perspective view of a distal end of an inserter with connected screw and inserted threader with thread at a first loading hole.

[0121] A bone screw 101 has a proximal end 103 and a distal end 105. In a longitudinal direction 113 of the bone screw 101, there is joined to the proximal end 103 a proximal body 107, which has internally a longitudinal bore 117. On the outside, a continuous screw thread 115 is guided along the proximal body 107, starting from the proximal end 103 to a distal opening 121 on the distal end of the longitudinal bore 117.

[0122] In the region of the distal opening 121, the proximal body 107 transitions to a distal tip 109 having a plate plane 111. In the longitudinal direction 113, joined to the distal opening 121 is a first loading hole 123, which runs transversely through the plate plane 111. The first loading hole 123 has a quadrilateral shape transverse to the longitudinal direction 113, wherein the corners of the square shape are rounded. A web 135 connects in the longitudinal direction 113 to the first loading hole 123. Following the web 135 in the longitudinal direction 113 is a second loading hole 125, which is formed as a round through-hole through the plate plane 111 and has on its distal end a gap opening 129.

[0123] The distal tip 109 tapers from the distal opening 121 to the distal end 105 of the bone screw 101 (see FIG. 1). Due to this tapering, the round shape of the second loading hole 125 and the gap opening 129, a clamping wing 127 is formed on each of the two sides of the second loading hole 125.

[0124] An internal hexagonal profile 141 is arranged on the proximal end 103 inside within the proximal opening 119 of the continuous longitudinal bore 117 (FIG. 2).

[0125] In an alternative of the bone screw 101 (FIGS. 3 and 4), the bone screw also has a plurality of perforations 139 extending through the proximal body 107, which are distributed at regularly spaced intervals over the cross-sectional surface and in the longitudinal direction 113 of the proximal body 107 (and thus the exterior surface), to improve later in-growth of a bone into the bone screw 101.

[0126] A hollow shaft 203 of an inserter 201 having an external hexagonal profile 217 on its distal end is inserted into the longitudinal bore 117 inside the bone screw 101. Accordingly, the hollow shaft 203 has a longitudinal direction 205, which coincides with the longitudinal direction 113 of the bone screw 101. The external hexagonal profile 210 is in contact on the inside with the walls of the longitudinal bore 117 of the bone screw 101. A shoulder of the hollow shaft 203 is in contact with the proximal end 103 of said screw.

[0127] Furthermore, the hollow shaft 203 of the inserter 201 has a slit 215, which is arranged before the external hexagonal profile 217 and is connected to the hollow space 213 (see FIG. 5).

[0128] Furthermore, in this alternative of the bone screw 101, the first loading hole is expanded upward (as shown in FIG. 4) in an approximately conical manner transverse to the longitudinal direction 112. By means of a non-depicted threading aid, a wire loop of the threading aid is pushed from the outside through the slit 215 and the hollow space 213 of the hollow shaft 203 in the longitudinal direction 205 to the distal opening 121. Due to the approximately cone-shaped, upwardly expanding form of the first loading hole 123 transverse to the longitudinal directions 205 and 113, the wire loop is guided upward to the outside through the upper opening of the first loading hole 123 so that said loop lies over the top side of the web 135 (not depicted in FIG. 5). Subsequently, a non-depicted suture thread can be threaded through this wire loop.

[0129] The bone screw 101 may be loaded with a thread 307 in different ways. For conventional loading, the thread 307 is guided through the gap opening 129 around the distal end of the web 135 and its side walls and the two thread ends go through the longitudinal bore 117 inside the proximal body 107 and the proximal opening 119 on the proximal end 107 of the bone screw to the outside (see FIG. 6).

[0130] For the knotless loading of the bone screw 101 using a threader, the thread is also guided through the second loading hole 125 around the distal side of the web 135, wherein a thread end is guided on the outside over the screw thread 115 to the proximal end 103 of the bone screw 101 and the other thread end is pulled through the longitudinal bore 117 inside the bone screw 101 to the proximal end 103 (see FIG. 7).

[0131] In a third knotless loading option, the thread 307 is manually threaded by the surgeon through the gap opening 129 into the second loading hole 125 and again lies around the distal end of the web 135. The two ends of the thread 307 are pulled up on the outside over the screw thread 117 to the proximal end 103 (see FIG. 8).

[0132] All three loading variants of the bone screw 101 depicted in FIGS. 6 to 8 having one or a plurality of threads can be combined with each other as desired.

[0133] In an alternative of the bone screw 101 having perforations 139, the first loading hole 123 has an inclined abutment surface 137 on the distal end of the first loading hole 123, wherein the inclined abutment surface 137 is formed in a tapering manner on both sides in the direction of the proximal end 103 (see FIG. 9). The inclined abutment surface 137 begins midway along the height of the distal-side wall around the first loading hole 123 and has a gradient of 10° or 15°. By means of this inclined abutment surface 137, an eyelet pushed through the longitudinal bore 117 of the proximal body 107 and through the distal opening 121 longitudinally into the first loading hole 123 is deflected and guided upward and out over the web 135.

[0134] Furthermore, FIG. 9 depicts in a magnified manner the distal end 105 of the distal tip 109. The gap opening 129 has a gap width 131. In the longitudinal direction 113 to the distal end 105, the gap opening 129 with the constant gap width 131 is followed by a conically opening clearance space 133, so that on both sides of the second loading hole 125 and the gap opening 129 two clamping wings 127 are formed. The gap width 131 of the gap opening 129 is hereby selected in such a manner that a thread guided by hand or by means of a threading aid from the outside, when subjected to a force, can be pushed through the conical clearance space 133 into the second loading hole 125.

[0135] A bone anchor system consists of an inserter 201 and a bone screw 101 (FIG. 10). The inserter 201 has a hand grip 207. In the top and bottom of the hand grip, a groove 209 in each case is routed from the distal end of the hand grip to the proximal end of the hand grip 207. A thread spool 211 is arranged at the proximal end of the hand grip 207.

[0136] Furthermore, the inserter 201 has a hollow shaft 203, as the latter is already depicted in FIG. 5. Inserted through the slit 215 of the hollow shaft 203 is a threader 301 with a wire 303 and a terminal eyelet 305, wherein the wire 303 and the eyelet 305 are guided through the hollow space 213 of the hollow shaft 203 and through the longitudinal bore 117 of the bone screw 101 so that the eyelet 305 is pushed out over the distal end 105 of the distal tip 109 (see FIG. 10).

[0137] Due to the inclined abutment surface 137 of the first loading hole 123, the eyelet 305 is deflected upward through the first loading hole 123 (FIGS. 11 and 12 show the state of the eyelet 305 just contacting the inclined abutment surface 137).

[0138] As depicted particularly in FIG. 13, the eyelet 305 is thereby pushed through on the top side of the distal tip 109 beyond the distal end 105 and a thread 307 can be pulled through the eyelet 305 in a threading direction 309. Subsequently, the threader 301 is pulled out again from the slit 215 to such a distance that the eyelet 305 finds its way into the region of the first loading hole 123 with the gap opening 129 and the thread 307 is threaded through the gap opening 129 into the second threading hole 125. Thereupon, one proceeds onward as described above in regard to FIG. 7.

[0139] In an alternative, the wire 303 of a threader 301 having a eyelet 305 arranged on the end is pushed through the first loading hole 123, and a thread 307 is pushed through the eyelet, wherein the two thread ends are oriented opposite a direction of the threader 301. Subsequently, the threader 301 is pulled upward so far that the eyelet 305 with the thread ends is pulled out at the top through the first loading hole 123.

[0140] Thereupon, a thread end of the thread 307 is taken out of the eyelet 305 and the eyelet 305 is removed from the thread 307. Subsequently, these two thread ends of the thread 307 are guided on both sides of the bone screw 101 and the hollow shaft 203 of the inserter 201 to the proximal end of the inserter 201 at its hand grip 207 and attached there as described above. This manual loading of the first loading hole 123 represents an additional loading option to the loading options described above and depicted in FIGS. 6 to 8.

[0141] Thus, a bone screw 101 is provided, which on the basis of the design of the first loading hole 123 and the second loading hole 125 can be flexibly preloaded and also be loaded with a thread or a plurality of threads using various loading methods and concepts during a surgery so that a flexibly usable bone screw 101 is provided for fixing a detached tissue to a bone.

LIST OF REFERENCE NUMBERS

[0142] 101 Bone screw [0143] 103 Proximal end [0144] 105 Distal end [0145] 107 Proximal body [0146] 109 Distal tip [0147] 111 Plate plane [0148] 113 Longitudinal direction [0149] 115 Screw thread [0150] 117 Longitudinal bore [0151] 119 Proximal opening [0152] 121 Distal opening [0153] 123 First loading hole [0154] 125 Second loading hole [0155] 127 Clamping wing [0156] 129 Gap opening [0157] 131 Gap width [0158] 133 Conical clearance space [0159] 135 Web [0160] 137 Inclined abutment surface [0161] 139 Perforation [0162] 141 Internal hexagonal profile [0163] 201 Inserter [0164] 203 Hollow shaft [0165] 205 Longitudinal direction [0166] 207 Hand grip [0167] 209 Groove [0168] 211 Thread spool [0169] 213 Hollow space [0170] 215 Slit [0171] 217 External hexagonal profile [0172] 301 Threader [0173] 303 Wire [0174] 305 Eyelet [0175] 307 Thread [0176] 309 Threading direction