This application is a §371 application of PCT/EP2009/067135 filed Dec. 15, 2009, which claims priority from German Patent Application No. 10 2008 054 825.1 filed Dec. 17, 2008.
The invention relates to an insertion instrument for the hip endoprosthesis for inserting socket inserts into endoprosthetic hip sockets as described herein.
There exist on the market a large number of prosthesis systems for replacing the natural hip joint in the event of painful, traumatic, arthrotic or other changes. Generally, so-called modular systems are used in which there is inserted into a hip socket, which generally comprises a metal alloy, a socket insert which forms a portion of the artificial sliding bearing and which may comprise a metal alloy, a ceramic material, a plastics material or a composite of the above-mentioned materials. The connection between the socket insert and the hip socket is often brought about by means of a so-called conical clamping, wherein a cone-like portion of the external geometry of the socket insert forms a frictionally engaged connection with a correspondingly cone-like portion of the internal geometry of the hip socket, cf.
One of the problems which may occur intra-operatively is the skewed insertion of the socket insert into the hip socket. Jamming of the socket insert between three contact points within the clamping cone of the hip socket may then occur in place of the conical clamping described. In accordance with the magnitude of the force applied during clamping, such high frictional forces occur as a result of the point-like jamming that the position of the socket insert can no longer be corrected intra-operatively, cf.
The consequences for the function of the hip joint prosthesis with the socket insert inserted in a pivoted manner substantially depend on the material of the socket insert and range from increased wear and corrosion to complete destruction of the socket insert. For instance, a socket insert inserted in a skewed manner may be the cause of a subsequent complex, painful and expensive revision operation.
In order to prevent the skewed insertion of socket inserts, a range of insertion instruments are commercially available. Their operation is substantially based on the following three steps:
The upper outer edge of the socket insert is gripped by the instrument generally by means of a so-called three-point fixing arrangement. To that end, the instrument has claw-like elements which project beyond the outer edge of the socket insert at least at three points and apply a normal force or friction force to a point-like location below the front face of the socket insert.
The orientation of the instrument with the socket insert is generally carried out by positioning the instrument on the front face of the hip socket or on elements (for example, recesses or protrusions) near the front face which are again in a plane parallel with the front face.
The abrupt ejection of the socket insert out of the gripper elements, with a clamping action being produced between the socket insert and the hip socket, is generally carried out by an additional ram on the insertion instrument or using a so-called impactor instrument.
Such insertion instruments are described, for example, in EP 1076537 B1 and DE 29922792 U1.
Disadvantages of the existing solutions are as follows:
The problems described are solved by an insertion instrument according to the invention according to the features of the present invention.
The insertion of socket inserts into endoprosthetic hip sockets and anchoring at that location by means of conical clamping are carried out with an insertion instrument according to the invention which is positioned on the front face of the socket insert and which is clampingly connected thereto by means of holding claws. For insertion, the socket insert with the insertion instrument positioned thereon is inserted into the endoprosthetic hip socket without any mutual contact at that time and positioned. Subsequently, the socket insert slides out of the holding claws of the insertion instrument owing to pressure on the socket insert or the spherical recess of the socket insert with sufficient connection force and engages with the hip socket with frictionally engaged contact.
The insertion instrument is used only to grip and to accurately position the socket insert in the hip socket. The pressure on the inner spherical recess of the socket insert until the connection force is sufficient is brought about without any pressure transmission devices directly and exclusively by the fingers of the user. The disadvantages described are thereby overcome and the surgeon or user receives direct tactile information regarding occurrences in the field of operation and does not suffer any perceived loss of control.
The insertion instrument according to the invention is characterised in that the support element surrounds a freely accessible, effective penetration face which is substantially circular and whose centre point is on the longitudinal axis of the insertion instrument. The substantially circular, effective penetration face must be large enough for a finger of the user or surgeon to be able to fit through. The penetration face must be so small that the insertion instrument has adequate stability and, on the other hand, must not be so small that fingers of the user cannot be fitted through.
In a preferred embodiment, the effective diameter of the penetration face is greater than or equal to 2.0 cm, particularly preferably greater than or equal to 2.5 cm.
The term effective diameter is intended to refer to the diameter of the circle in a support element that encloses a circle as a penetration face (cf.
In an inventive construction, the resilient elements and the support element are combined to form an integral resilient support element and the holding claws are arranged on the resilient support element. In that embodiment, the insertion instrument is integral and is easy to produce.
The resilient support element is preferably a resiliently flexible ring, the holding claws being arranged on the outer periphery of the ring. For positioning on the outer edge of the socket insert, the holding claws only have to be pushed by radial expansion over the outer edge of the socket insert, that is to say, the resilient support element is deformed and a resilient force acts on the holding claws. Consequently, each holding face of the holding claws applies a pressing force to the socket insert, which force is equal to the resilient force on the holding claw in terms of magnitude and direction, respectively.
In another inventive construction, the resilient support element has a triangular shape or polygonal shape. A concertina-like shape may also be advantageous. It should always be ensured that the effective penetration face is large enough for a finger to be able to be fitted through. The resilient force can be adjusted by the formation of the shape of the resilient support element.
In an alternative embodiment, the support element and the resilient elements are separate components and the holding claws are connected to the support element by means of the resilient elements. The resilient forces can be adapted individually by the resilient elements being selected in a suitable manner.
In one embodiment, the resilient elements have a concertina-like shape which is preferably arranged perpendicularly relative to the plane of the holding claws. Alternatively, the resilient support element or the support elements have a cross-section which varies in terms of the height and width thereof between the holding claws in order to produce flexurally more rigid and flexurally less rigid zones.
The resilient support element or the support elements can also have a change in the cross-sectional geometry between the holding claws in order to produce flexurally more rigid and flexurally less rigid zones.
The invention is explained in greater detail below with reference to Figures.
With regard to
In this embodiment, the insertion instrument comprises a flexible, annular resilient support element 12, which three holding claws 2 adjoin. The insertion instrument is advantageously constructed from a technical perspective relating to production as a monolithic component which can be produced, for example, by injection moulding. The resilience of the resilient support element 12 results in the holding claws 2 being able to be displaced radially. The resilient force to be overcome increases with increasing radial displacement of the holding claws 2. The force/path characteristic of the holding claws 2 can be influenced by corresponding geometric formation of the annular resilient support element 12.
The holding claws 2 each have a holding face 3 (cf.
According to the invention, the insertion instrument has such dimensions that the holding claws 2 can only be fitted over the outer edge of the socket insert 17 by being radially expanded. That is to say, the resilient support element 12 is deformed and a resilient force acts on the holding claws 2. Consequently, each holding face 3 applies to the socket insert 17 a pressing force which is equal to the resilient force at the holding claw 2 in terms of magnitude and direction. Owing to the pressing forces, friction forces which act counter to the insertion instrument being drawn away from the socket insert 17 also act between the holding faces 3 and the outer face of the socket insert 17. This is important for the operation of the insertion instrument.
If the socket insert 17 with an insertion instrument assembled is pushed into a hip socket 18, the holding claws 2 move into contact at their lower end 6 with the front face of the hip socket 18. Since the holding claws 2 all have the same extent in a downward direction, the contact points form a plane which is parallel with both the front face of the hip socket 18 and the front face of the socket insert 17. Consequently, orientation of the two front faces is thereby also brought about so that they are parallel with each other. Possible skewing of the socket insert 17 is thereby counteracted. Slight displacement of the socket insert 17 in the hip socket 18 is possible owing to the lateral gap which still exists at this time between the socket insert 17 and the hip socket 18. By pushing the socket insert 17 back and forth repeatedly in the hip socket 18—until stopping lightly in each case—with the finger 7, it is possible for the user to check the correct position of the socket insert 17 in the hip socket 18. Above all the provision of slight displaceability and the stopping of the components provide the user with very good tactile feedback concerning the correct position of the socket insert 17 in the hip socket 18.
In order finally to push the socket insert into the hip socket 18 as far as frictionally engaged contact between the two cone faces—externally on the socket insert 17 and internally on the hip socket 18—the friction forces between the holding faces 3 of the insertion instrument and the outer face of the socket insert 18 have to be overcome. This is brought about by continuously increasing, or preferably by abruptly increasing, the axial connection force by the finger 7 of the user. The socket insert 17 travels over the short path remaining and slides into the hip socket 18, substantial skewing of the socket insert 17 no longer being possible. Possible slight skewing actions are compensated for and corrected by the self-centring action of the conical clamping connection.
As soon as the holding claws 2 have disengaged from the socket insert 17, the resilient element or the resilient support element 12 moves back into its initial shape. Owing to that rapid restoring movement, the insertion instrument is further pressed away from the front face of the hip socket 18 and slides a few centimeters along the finger 7 of the user until the movement of the insertion instrument stops. If the user wears latex gloves, as necessarily provided for during operations, the insertion instrument remains suspended on the finger of the user owing to the glove. The user thereby necessarily removes the insertion instrument from the operating field if he takes his hand out of the operating field.
The advantages of the construction according to the invention involve:
Other embodiments result by varying the formation of the annular resilient element, that is to say, the resilient support element 12. On the one hand, the basic form of the resilient support element 12, in the view from above according to
As a result, for example, triangular or polygonal geometries are also conceivable, cf.
It is further possible to construct the direct connection paths between the three holding claws 2 by resilient path elements. If, for example, a concertina-like construction of the connection paths 13 is carried out (cf.
It is further conceivable not to arrange the concertina-like formation in a plane parallel with the plane of the holding claws, but instead perpendicularly thereto, cf.
The cross-section of the annular, resilient element or the resilient support element 12 may be varied with a cyclical shape over the periphery of the annular, resilient element or resilient support element 12. For instance, the force/path characteristic of the holding claws 2 and the shape of the annular, resilient element or the resilient support element 12 can be influenced during the deformation. It is thereby also possible selectively to prevent or influence possible occurrences of torsion of the annular element during deformation, for example, if undesirable skewing of the holding claws 2 at the edge of the socket insert 17 or the hip socket 18 could occur owing to torsion.
The cross-section can be varied by changing the height and width thereof so that flexurally flexible and flexurally rigid zones are produced, for example, flexurally rigid zones in the region of the holding claws 2 and flexurally flexible zones in the region between the holding claws 2, cf.
It is also further conceivable to have complete changes of the cross-sectional geometry over the periphery, for example, rectangular cross-section in the region of the holding claws up to a round cross-section precisely at the centre of the ring between two holding claws 2, cf.
It is also conceivable to have stepless optimisation of the cross-sectional geometry by means of finite element simulation and using so-called adaptation algorithms. The resultant geometry may deviate as desired from the initial cross-section (for example, rectangular shape or circular shape) of the optimisation but is within the correspondingly prescribed dimensional limits.
Consequently, according to the invention the insertion instrument comprises holding claws 2 which adjoin the outer side of the socket insert 17 (cf.
Number | Date | Country | Kind |
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10 2008 054 825 | Dec 2008 | DE | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2009/067135 | 12/15/2009 | WO | 00 | 6/21/2011 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2010/069940 | 6/24/2010 | WO | A |
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Number | Date | Country | |
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20110245837 A1 | Oct 2011 | US |