Patent Grant
11065013
The present invention relates to a positioning device for the plate osteosynthesis according to the preamble of claim 1, further to a push-in sleeves arrangement according to the preamble of claim 17.
Plates are known aids for the treatment of fractures of e.g. long tubular bones, but also of other bones. They are connected to bones by screws.
In hitherto known plates, the screws are screwed in the bone through discrete openings of the plate in a predetermined position relative to the plate. The exact placing of the screws in the bone requires a great experience by the surgeon.
It is an object of the present invention to provide a positioning device for fixing a plate to a bone or the bone to a plate. Furthermore, a push-in sleeves arrangement should be specified.
The object according to the present invention is achieved with a positioning device having the features of claim 1. It is further achieved with a push-in sleeves arrangement having the features of claim 17.
The positioning device serves for positioning and/or fixing a plate to a bone. It comprises a guiding bow. The guiding bow is designed at least in one section thereof as a push-in section to be inserted in a sleeve of a push-in sleeves arrangement, comprises such a push-in section or is connected thereto.
The guiding bow comprises or is connected to an adjusting device, wherein the adjusting device comprises at least one targeting device. The targeting device is designed to receive, at least in section, an interlocking device or an instrument for acting on the interlocking device.
The push-in sleeves arrangement according to the present invention comprises at least one or a plurality of sleeves for the insertion of the push-in section of a positioning device therein, in particular the positioning device according to the present invention.
In all of the following statements, the use of the expression “may be” or “may have” and so on, is to be understood synonymously with “preferably is” or “preferably has,” and so on respectively, and is intended to illustrate embodiments according to the present invention.
Whenever numerical words are mentioned herein, the person skilled in the art shall recognize or understand them as indications of numerical lower limits. Hence, unless it leads to a contradiction evident for the person skilled in the art, the person skilled in the art shall comprehend for example “one” as encompassing “at least one”. This understanding is also equally encompassed by the present invention as the interpretation that a numeric word, for example, “one” may alternatively mean “exactly one”, wherever this is evidently technically possible in the view of the person skilled in the art. Both of these understandings are encompassed by the present invention and apply herein to all used numerical words.
Advantageous developments of the present invention are each subject-matter of the dependent claims and embodiments.
In several exemplary embodiments according to the present invention, the push-in section is, or comprises, a push-in rod.
In several exemplary embodiments according to the present invention, the positioning device comprises a push-in sleeves arrangement which comprises a plurality of sleeves for inserting the push-in section into them.
In several exemplary embodiments according to the present invention, at least two of the sleeves comprise each a longitudinal axis. Not each of these longitudinal axes are parallel to each other.
The positioning device may in several exemplary embodiments according to the present invention be referred to as monoaxial, when or if the positioning device is designed or arranged for introducing the interlocking device, e.g. a bone screw, into the particular through-opening of the plate at only one angle.
In several exemplary embodiments according to the present invention, the push-in sleeves arrangement comprises a plate holder connected thereto. The plate holder extends preferably from the push-in sleeves arrangement.
In several exemplary embodiments according to the present invention, the plate holder comprises a first connection via which the plate holder is connected or connectable to a further section of the push-in sleeves arrangement in a releasable manner.
In several exemplary embodiments according to the present invention, the plate holder comprises a second connection for connecting it to a plate for osteosynthesis.
In several exemplary embodiments according to the present invention, the first and/or the second connection is designed as, or comprises, a screw connection. The first connection and/or the second connection may be a combination of several connection mechanisms, e.g. screw connections and push-in connections at the same time.
The plate may be designed as polyaxial or monoaxial or as a combination thereof. The same may apply to the positioning device according to the present invention.
“Polyaxial” may be understood such that the positioning device which is connected to the plate is designed or arranged for inserting the interlocking device, e.g. a bone screw, into a particular through-opening at a plurality of angles, also called multidirectional.
“Monoaxial” may be understood such that the positioning device which is connected to the plate is designed or arranged for inserting the interlocking device, e.g. a bone screw, into a particular through-opening of the plate at only one angle.
The plate may in several exemplary embodiments according to the present invention be referred to as polyaxial, when or if the positioning device is designed or arranged to insert the interlocking device, e.g. a bone screw, into the particular through-opening at more than only one angle.
In several exemplary embodiments according to the present invention, the push-in section comprises at least one guiding pin extending radially therefrom. The guiding pin serves for guiding the push-in section within a sleeve being selected from the plurality of sleeves. Said guiding may optionally take place along a longitudinal groove (also referred to as groove) provided in each of the sleeves.
In several exemplary embodiments according to the present invention, each of the plurality of sleeves comprises at least one longitudinal groove.
In several exemplary embodiments according to the present invention, the arrangement of the sleeves and the arrangement of the push-in section are interchanged with each other. The push-in section may thus be placed or located on the component denoted as push-in sleeves arrangement and the sleeve or the sleeves may be placed on the positioning device.
In several exemplary embodiments according to the present invention, the longitudinal groove does not extend along the total length of the sleeve. This may ensure that the insertion may be limited upon inserting the push-in section into the sleeve. Additionally or alternatively, the width of the longitudinal groove is not constant over or along the total length of the sleeve. This may allow the guiding pin to jam or engage in an end section of the groove, ensuring for example a deadlock or clamping, an optimal positioning of the guiding bow relative to the sleeve and/or to the plate.
In several exemplary embodiments according to the present invention, the longitudinal groove extends at least in section also in the circumferential direction of the sleeve. This may advantageously allow that the push-in section interlocks with the sleeve and/or prevent that the push-in section slips out of the sleeve unintentionally.
In several exemplary embodiments according to the present invention, the longitudinal groove comprises at least one fitting section which provides a predetermined fit with the guiding pin.
In several exemplary embodiments according to the present invention, the longitudinal groove comprises the at least one fitting section in an end section of the longitudinal groove or in a region in which a guiding pin should rest after having inserted the push-in section into the sleeve. The remaining sections of the longitudinal groove are wider than the fitting section. Thus, the guiding section may be easily inserted into the longitudinal groove and takes the snug fit only when the insertion is about to be completed.
In several exemplary embodiments according to the present invention, the cross-sectional shape of the sleeve is oval, rectangular, non-annular, angular, triangular, etc.
In several exemplary embodiments according to the present invention, the cross-sectional shape of the sleeve (oval, rectangular, non-annular, angular, triangular, etc.) is designed such that the axis and the alignment of the guiding pin and hence of the guiding bow are determined around or about this axis.
In several exemplary embodiments according to the present invention, the height limit or limitation of the guiding pin and thus of the guiding bow along the axis of the sleeve and thus of the guiding pin is determined via a fitting at the front/end side of the sleeve relative to or vis-à-vis a step of the guiding pin.
In several exemplary embodiments according to the present invention, the height limit of the guiding pin and thus of the guiding bow along the axis of the sleeve and thus of the guiding pin is determined via a fitting at the front/end side of the sleeve relative to or vis-à-vis a step which is shiftable or adjustable in axial direction.
In several exemplary embodiments according to the present invention, the height limit of the guiding pin and thus of the guiding bow is determined between guiding pin and sleeve along the axis of the sleeve and thus of the guiding pin through a fitting on the front/end side of the sleeve relative to a spacer between guiding pin and sleeve with different lengths.
In several exemplary embodiments according to the present invention, the plurality of sleeves is denoted by markings on the push-in sleeves arrangement. This designation may specify which opening or through-opening of the plates the interlocking device which is received in the targeting device of the adjusting device is directed to or aligned with. This may facilitate work for the surgeon. Sleeves and opening or through-opening may be uniquely or unambiguously marked so that an alignment or attribution 2 of a particular sleeve is possible to—preferably only—one particular through-opening.
The markings on the plate may be designed to be read or recognized by screening or x-ray.
In several exemplary embodiments according to the present invention, the plurality of sleeves is screwed to other sections of the push-in sleeves arrangement, is connected by fitting, by gluing and/or by dowel pin.
In several exemplary embodiments according to the present invention, each of the plurality of sleeves has at least one opening for at least one dowel pin.
In several exemplary embodiments according to the present invention, the push-in section comprises in its outer surface or shell surface a through-opening for guiding through a guiding pin. The push-in section comprises in an interior thereof at least one longitudinal opening, wherein in the interior or in the longitudinal opening a rod is rotatably arranged carrying on its outer surface the guiding pin or from which the guiding pin protrudes, wherein the guiding pin is led through the through-opening.
In several exemplary embodiments according to the present invention, the sleeve comprises, e.g. in its outer surface or shell surface, at least one or exactly one guide or dowel pin as rotation-proof or as anti-twist safeguard. The push-in section may comprise at least one groove or longitudinal opening.
In several exemplary embodiments according to the present invention, the rod comprises a hand element for turning the rod by hand within the longitudinal opening of the push-in section.
In several exemplary embodiments according to the present invention, the positioning device is connected to the push-in sleeves arrangement. The push-in sleeves arrangement is in turn connected to a plate for osteosynthesis. The plate comprises a plurality of openings or through-openings for receiving one or several interlocking devices. The depth of the through-openings respectively corresponds to a thickness of the plate at the location of the through-opening. Among the plurality of sleeves there is at least one that corresponds to one or to several of the through openings. The adjusting device is designed such if the push-in section—preferably having, if provided, an interlocked guiding pin—is inserted into one of the sleeves, the targeting device received in the adjusting device is aligned and movable in a predetermined way. This predetermined movement is optionally set such that an interlocking device received in the targeting device or an instrument received in the targeting device is moveable within a cone surface. The cone tip rests thereby within the depth of that through-opening to which the interlocking device has been directed by selecting the associated sleeve into which the push-in section was inserted.
Preferably, the tip of the virtual cone or of the cone determined by calculation, rests on a longitudinal axis of the corresponding through-opening, i.e. for example in the hole center when the through-opening is seen from top.
Whenever the word cone is mentioned herein, it should not be understood as limiting. The term “cone tip” may also be understood to mean the intersection of two or several directions for introducing the interlocking device which are achievable by moving the interlocking device using the adjusting device. An actual or specific cone shape is not essential or mandatory here.
In several exemplary embodiments according to the present invention, the push-in sleeves arrangement comprises one or several of the features described herein in relation to one or several sleeves in any combination, unless such combination is recognized by the person skilled in the art as technically impossible.
The push-in sleeves arrangement according to the present invention may be used for the minimally invasive introduction of the plate to a bone.
The guiding bow may be used as aid for minimal-invasively introducing the plate on or to the bone and may be variably adjusted relative to the plate.
The guiding bow may be used for positioning and/or fixing of wires, denoted also as K-wires or Kirschner-wires, through or from one plate to a bone.
The positioning device according to the present invention comprising the connection between plate and push-in arrangement, the push-in arrangement and the guiding bow with the adjusting device may be made of materials transparent to X-rays.
Some or all of the embodiments according to the present invention may comprise one, several or all of the advantages mentioned supra and/or in the following.
With the positioning device according to the present invention, it is advantageously possible to correct, during surgery, minor misalignments when positioning and/or when screwing interlocking screws into a plate.
With the positioning device according to the present invention it is advantageously possible to correct, during surgery, misalignments of the bone by inserting an interlocking screw and subsequently by repositioning (the so-called corrective or transposition osteotomy) through or by means of the plate.
The position and the angle of bores for the interlocking screws and their positions may advantageously be adapted, still intraoperatively, to the individual anatomical situation and to an injury-caused situation by using the positioning device according to the present invention.
Furthermore, with the positioning device according to the present invention the angle of the interlocking screw penetrating or reaching through the plate may still be varied intraoperatively in order, e.g., to reposition the fracture fragments, to anatomically correctly adapt them or to reposition the bones relative to each other according to a corrective or transposition osteotomy.
By the present invention, the positioning device may be securely and simply connected, in a releasable manner, to the plate to be fixed. Thus, the positioning device may be decoupled and removed from the fixed plate. The push-in sleeves arrangement may advantageously ensure that the positioning device does not rotate, preferably not relative to the plate, during the screwing or during the release of the screw connection between bone and plate.
According to the present invention, the positioning device may enable a minimally-invasive implantation of polyaxial osteosynthesis plates. The surgeon may align the positioning device on one or several particular through-opening(s) using the push-in sleeves arrangement, even if he cannot see neither the positioning device nor the plate. The surgeon may hereby use screening (or radioscopy) or x-rays, but only if he himself chooses to do so.
Both the positioning device and the push-in sleeves arrangement may be handled intuitively. To move the positioning device within the push-in sleeves arrangement advantageously requires only one step, namely for removing the push-in section out of one sleeve and inserting it into another.
The present invention is exemplarily explained with regard to the accompanying figures, in which identical reference numeral refer to the same or similar component. The following applies in the schematically simplified figures, respectively:
The positioning device 100 may be designed in any way disclosed in WO 2016/008849 A1, the disclosure of which is hereby incorporated by reference in its entirety.
The plate 300 comprises through-openings 301, 303, 305, 307, 308 for screwing or interlocking the plate 300 to a bone.
In this, a longitudinal or rotational axis of the through-openings 301, 303, 305, 307, 308 is parallel to a longitudinal axis of at least one or exactly one of the sleeves 201, 203, 205 and 207 and possibly others, of the push-in sleeves arrangement 200.
The instrument 23 for inserting screws may selectively and depending on the desired fixing and screwing of the plate 30 on the bone be inserted into a positioning aid 17 in the guiding bow 1.
The sleeves 201, 203, 205 and 207 comprise each a groove 201′, 203′, 205′ and 207′ which serve for receiving the guiding pins 150, 153 and/or 155 of the push-in section 150.
The groove 201′, 203′, 205′ of the sleeves 201, 203, 205 are designed to specify the push-in section 150 by one guiding pin 151 both in its height and rotation (in each case relative to the sleeve).
For this purpose, the grooves 201′, 203′, 205′ may each have an optional curvy course and/or an end-side fitting section 201a, 203a, 205a, or 207a, in which the guiding pin 151 may be fittingly inserted. The fitting sections 201a, 203a, 205a, or 207a on the one hand and the guiding pin 151 on the other may optionally jointly effect a centering.
The example of the sleeve 201 shows that each sleeve may comprise at least one opening 201′ for receiving at least one fitting pin by which the sleeve may be fixed and/or aligned on the push-in sleeves arrangement 200.
The example of the sleeve 207 however shows that the height and rotation angle of the push-in section 150 may be ensured by more than only one guiding pin. The groove 207′ which comprises a fitting section 207a may, using a guiding pin 153, protect against an undesired rotation. A second guiding pin 155 may prevent the push-in section 150 from being inserted too deep into the sleeve 207 e.g. by or due to resting on the upper edge of the sleeve 207. Alternatively, the second guiding pin 155 may contact the sleeve 207 or be connected thereto in a different way.
As is not only seen in
In
The tip or head of the cone should thereby rest, as shown by dashed lines, in the thickness of the plate 300 which is shown here in section from the side, or in one of the openings 305 for the interlocking device which is not shown.
The embodiment may relate to a set having or consisting of the polyaxial positioning device 100 and/or the monoaxial positioning device 100′, the push-in sleeves arrangement 200, the plate holder 209 and optionally one or several plates 300.
The adjusting device 3 is designed optionally as a section of a spherical surface with a circular or round opening. The form of the adjusting device 3 may comprise instead of a spherical surface likewise a different shaped surface, only optionally curved or straight.
The adjusting device 3 is optionally fixed to the guiding bow 1.
The exemplary circular opening in a central or middle area of the adjusting device 3 is provided for guiding the targeting device 5 and the instrument 23 (which serves for inserting the interlocking screw 21). The longitudinal axis of the instrument 23 is perpendicular to the spherical surface. The extension of the longitudinal axis of the instrument 23 extends through the center of a bore or a through-opening of the plate 300.
The instrument 23 is guided to the targeting device 5. The targeting device 5 is optionally shell-like formed having grooves, notches or protrusions which are annularly concentrically arranged about the middle guide of the instrument 23. The shell-like formed targeting device 5 may be referred to as middle shell, which, viewed in the radial direction, is arranged between the outer shell which corresponds to the adjustment device 3 and the inner shell which corresponds to the shell-shaped fitting surface of the guiding bow 1.
The targeting device 5, i.e. the middle shell, may be moved or shifted between the inner and the outer shell. In this movement, optional pins (not shown), supported in radial direction by springs, engage in the annular grooves or notches of the targeting device 5. A defined and exact positioning of the instrument 23, and thus of the interlocking screw 21, is thus possible. The distances between the grooves correspond to a specific and predetermined deflection of the targeting device 5, which may be indicated with an angle or degree number. In this embodiment, the deflection between two annular grooves corresponds to an angle or a degree number of degree (1°). This principle or concept with pins supported by springs in which these pins engage into grooves, may be referred to as spring-pin concept.
The arrangement in
With an optional combined form-fit connection (between the pins and the annular grooves of the targeting device 5) and a frictional connection (between the middle and the outer shell), fixing the position of the instrument 23 for screwing in or fixing the interlocking screw 21 is, hence, possible.
The targeting device 5 may optionally rest on a circular section of a structure which is arranged under the targeting device 5. In this way, it may be ensured that the targeting device 5 is preferably guided at a constant distance from a target point.
The targeting device 5 is fixed between the adjusting device 3 and the second section of the guiding bow 1 by a so-called tension wheel 67.
The targeting device 5 may comprise markings, e.g. the exemplarily shown concentric rings 109, on at least one surface which is shown as an option in
As an alternative or in addition to the concentric rings 109, a mechanical aid may be provided for the doctor, e.g. a snap-in device that gives a feedback for a snap-in being noticeable in the hand for a predetermined angular position, e.g. 0°. Such an optical or haptical orientation may be helpful when using monoaxial plates or in monoaxial implantation.
The mechanical aid may be a groove in which a pin passes or enters, or the like.
The guiding bow 1 is optionally two-piece. A first section 1a (in
A second section 1b of the guide bow 1 may be produced as one-part or multi-part.
The first section 1a and the second section 1b may be connected to each other at an interface 101 by means of a form-fit and/or material-bonding connection. For example, the second section 1b may be form-fit or positively pushed into a hollow end section of the first section 1a by a step. This form-fit connection may then be fixed and secured by one or several bolts 103 (the bolts 103 may be dowel pins). This form-fit connection may be additionally secured by an adhesive sealing. An adhesive sealing may be advantageous in order to ensure a play-free connection even after prolonged use and multiple mechanical stresses. A play-free connection may be important for a therapeutic success of an exact positioning and/or fixing of plates 300 by the positioning device 100″ according to the present invention.
The tension wheel 67 connects and fixes, in the mounted state, optionally the targeting device 5 and the adjusting device 3 to the guiding bow 1. The exemplary tension wheel 67 is explained in detail in
The targeting device 5 comprises the concentric rings 109 on at least one surface (on the right side in
Furthermore, the targeting device 5 comprises a longitudinal slot 111 on the circumference of the centrical, sleeve-shaped protrusion. This longitudinal slot 111 serves for an elastic deformation of the annular protrusion when inserting an instrument for inserting the interlocking screw 21 (see
The second section 1b of the guide bow 1 comprises an optional positioning aid 27 as a bore for further instruments (not shown) for inserting interlocking screws. This positioning aid 27 comprises also a longitudinal slot 113 (hidden) at one end (in
Furthermore, the second section 1b comprises an optional bore 115 for a connecting pin, in particular for a dowel pin. With this dowel pin, the second section 1b can be connected in particular to an extension (not shown in
The components shown in
The optional asymmetrical engagement contour of
Still, a tool can be used alternatively to a pure manual actuation of the tension wheel 67.
The different inclinations of the flanks are defined by the radii 133 and 135. The radius 133 may be approximately 6 mm and the radius 135 may be approximately 49 mm, by way of example.
In order to prevent a mutual twisting of the push-in section 150 and the sleeve 202, a pin, a dowel pin, a notch may be arranged in a step or the like thereto preferably on the outer diameter of the push-in section 150 and on the inner diameter of the sleeve 202.
In order to limit the axial shiftability of the sleeve 202 on the push-in section 150, a pin or the like may be inserted in optional cross bores 163 of the push-in section 150. Such a pin may be understood as an axial stop for the sleeve 202. With such an axial stop, the height or distance of the instrument 23 with regard to the plate 300 may be adjusted or set (see
The plate 300 fixed to the bone is connected to a plate holder 209. This connection may be a screw connection, a form-fit connection and/or a frictional connection. The connection may comprise a predetermined breaking point so that after a positioning and fixing of the plate 300 to the bone, the plate holder 209 may be bent off and thus broken off and advantageously detached from the plate 300 easily and quickly.
The plate holder 209 is connected to a push-in sleeves arrangement 200, e.g. by a screw connection. The push-in sleeves arrangement 200 comprises several sleeves 201, in which the guiding bow 1, depending on the desired positioning, may be inserted. With this positioning, the position of the guiding bow 1 is fixed relative to the plate 300 and to the bone. Subsequently, the K-wires for bone fixation may be inserted.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2016 103 681.1 | Mar 2016 | DE | national |
| 10 2016 103 754.0 | Mar 2016 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2017/054798 | 3/1/2017 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2017/149026 | 9/8/2017 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 20040102788 | Huebner | May 2004 | A1 |
| 20060264942 | Lim | Nov 2006 | A1 |
| 20070173836 | Prien | Jul 2007 | A1 |
| 20070173843 | Matityahu | Jul 2007 | A1 |
| 20080188852 | Matityahu | Aug 2008 | A1 |
| 20110106086 | Laird | May 2011 | A1 |
| 20180256222 | Lueth | Sep 2018 | A1 |
| 20200352582 | Larche | Nov 2020 | A1 |
| 20200388085 | Furnstahl | Dec 2020 | A1 |
| Number | Date | Country |
|---|---|---|
| 20013900 | Jun 2001 | DE |
| 102006016213 | Oct 2007 | DE |
| 10 2014 109935 | Jan 2016 | DE |
| 2 745 786 | Jun 2014 | EP |
| 2 523 021 | Nov 2014 | ES |
| 2016008849 | Jan 2016 | WO |
| Entry |
|---|
| International Search Report for PCT/EP2017/054798 dated Oct. 30, 2017. |
| English translation of search report for German application No. 10 2016 103 681.1 dated Oct. 7, 2016. |
| Number | Date | Country | |
|---|---|---|---|
| 20190133611 A1 | May 2019 | US |
