The present invention relates to a glenoid component for shoulder prosthesis comprising a glenoid coupling and a prosthetic coupling.
The present invention also relates to a shoulder prosthesis comprising a glenoid component.
In general, the present invention finds application in the prosthetic orthopedic field for shoulder surgery.
Within the present technical field, the erosion of the glenoid surface is a fairly frequent factor and must be taken into account in the context of shoulder prosthetic surgery.
Indeed, for a good result in the medium-long term it is necessary, during surgery, not only to re-establish the right tension of the soft tissues, but also to try to recover any bone deficits that may be present and cause sub-dislocation problems of the humeral head.
There are various types of glenoid erosions. Although the posterior ones are the most frequent, there are upper erosions, deformities of the glenoid with lower inclinations and central defects. All of these individual defects are often combined together in a specific case. For instance, the lower deformation of the glenoid combined with the rear erosion is one of the fairly frequent conditions in osteo-arthritic patients.
It is therefore important, intra-operatively, to identify the right type of defect and correct it by returning the version of the glenoid to a neutral condition. For instance, a prosthetic humeral head that articulates off-center could cause excessive and premature wear of the polyethylene component and at the same time cause failure of the glenoid component due to the phenomenon called “rocking-horse”.
In the prior art, this type of criticality has sometimes been remedied by means of an asymmetrical milling of the glenoid surface in order to bring back the glenoid to an original neutral version.
Although this expedient constitutes a still adopted solution, it has drawbacks, in particular linked to the fact that the asymmetrical milling of the surface has the disadvantage of removing a significant portion of bone to correct the defect, thus making it necessary to subsequently lateralize the components to properly tension the soft tissues.
A further methodology used nowadays involves the insertion of a bone graft into the area with a deficit. A disadvantage of this technique is the difficulty in retrieving the graft. In fact, the graft is usually taken from a bone bank or directly from the patient with operations that can be painful and have long recovery times (e.g. bone graft removal from the iliac crest). Furthermore, this methodology has the disadvantage of having an implant technique that is particularly complex and exposed to a possible human error, which could lead to a non-optimal result in the bone deformity recovery and a consequent non-optimal result in the prosthesis connection.
The use of an increased prosthetic component, such as the one covered by the present invention, allows overcoming these problems. In particular, the implant technique is much simpler for any user with ordinary knowledge of the field and at the same time allows obtaining good results.
An object of the present invention is to overcome drawbacks of the prior art.
A further object is to provide a component that is adapted to confer a particular effectiveness to the glenoid prosthesis system.
A further object is to provide a component that is adapted to confer greater convenience of application or of use by a surgeon.
A particular object of the present invention is to provide a device that allows recovering the typical bone deficits with different severities.
A further particular object of the present invention is to provide a solution that allows an immediate and standardized selection in the operating phase by a surgeon.
Still a further particular object is to provide a solution that allows a simple application by a surgeon.
Another particular object is to provide a structure of increased specific dimensions for the correction of bone deficits.
A further particular object is to provide a component that allows a quick coupling with further devices for prosthetic surgery such as bone pins.
Finally, a particular object of the invention is to provide a device that is particularly suitable for the standard productive process of prosthetic components.
These and other objects are achieved by means of the glenoid component according to the features of the appended claims which form an integral part of the present description.
An idea underlying the present invention is to provide a glenoid component for shoulder prosthesis, comprising a glenoid coupling surface adapted to be fixed to a bone and comprising a first convex portion having a first outer edge that defines a development plane, and a prosthetic coupling surface, opposite the glenoid coupling surface and adapted to house a second prosthetic component of the shoulder prosthesis, the prosthetic coupling surface comprising a second portion having a second outer edge that defines a reference plane. The glenoid component provides a predetermined offset between the development plane and the reference plane so as to define an increased thickness of the glenoid component, said increased thickness being adapted to properly compensate for a bone deficit.
Advantageously, the present invention provides the surgeon with a standard solution for a range of typical deformity situations with different severity found in the shoulder surgery.
In particular, the increased thickness of the glenoid component is defined by a maximum offset provided by a respective predetermined offset between the development plane defined by the first outer edge and the reference plane defined by the second outer edge. Preferably, the increased thickness of the glenoid component is defined by a maximum offset equal or larger than 15%, more preferably equal or larger than 25%, of the diameter of the glenoid component.
Preferably, the predetermined offset is configured to vary a longitudinal distance along the perimeters of the first outer edge and of the second outer edge, thus defining an angle between the development plane and the reference plane.
Advantageously, the present solution allows re-establishing the correct conformation in presence of bone deficits of the angular type, in particular at the posterior spherical glenoid surface.
Still preferably, the angle between the development plane and the reference plane is comprised between 2° and 30°, preferably comprised between 5° and 25°, more preferably available with increases of 5°.
Advantageously the present ranges are particularly effective in correcting typical bone deficits of the angular type and do not involve mechanical resistance problems of the component and do not require further milling operations.
According to an alternative embodiment, the predetermined offset is configured to substantially maintain a longitudinal distance along the parameters of the first outer edge and the second outer edge constant, wherein the development plane and the reference plane are substantially parallel to each other in defining the standard increased thickness.
Advantageously, this alternative embodiment is particularly suitable for central erosions of the glenoid, allowing the original thickness recovery.
Preferably, the longitudinal distance is comprised between 2 and 10 mm, more preferably comprised between 4 and 6 mm.
Advantageously, the present ranges are particularly suitable for the typical bone deficits of the central type in which it is further necessary to correctly tension the soft tissues.
Preferably the glenoid component further comprises a substantially truncated cone-shaped glenoid coupling element, protruding from said glenoid coupling surface and adapted to be coupled to a bone pin, the glenoid coupling element developing along an axis which is substantially perpendicular to the reference plane.
Advantageously, the present solution is suitable for being associated with bone pins of different lengths, making the glenoid component according to the present invention suitable for a plurality of different solutions.
Still preferably, the first convex portion of the glenoid component provides a substantially constant curvature radius, preferably comprised between 25 and 35 mm, more preferably between 27 and 30 mm, whereas the second portion is preferably concave.
Advantageously such conformation allows replicating in the best possible way the bone curvature radius of the original glenoid and to obtain the correct seat for the glenoid component using the same tool for all of the conformations.
Further preferably, the first outer edge of the glenoid coupling surface is substantially circular or oval or glenoid-shaped, whereas the second outer edge of the prosthetic coupling surface is substantially circular or oval.
Advantageously, a circular conformation allows an orientation of the glenoid component in a continuous way, which covers all types of defects over 360°.
The oval or glenoid-shaped conformations represent the optimal condition for a prosthesis of the anatomical type, in which the humeral head articulates on the glenoid surface, as it happens, precisely, anatomically. Indeed, these conformations are particularly suitable when the surgeon deems it necessary to use an anatomical prosthesis, for example in the case of a young patient with integrity of the rotator cuff.
Still preferably, the glenoid component further comprises at least two holes, preferably four holes, adapted to house fixing screws of the component.
Advantageously, the correct choice of the number of fixing screws allows a correct orientation of the component even in the case of hybrid bone deficits.
Preferably, according to an alternative embodiment, said holes are adapted to house respective angular locking screws.
Still preferably, the predetermined offset comprises a first offset at said holes and a second offset at a glenoid coupling element.
Said first and second offsets, in a particularly advantageous embodiment, have the purpose of providing an additional thickness in the screw holes, in order to introduce an angularly stable locking element.
Preferably, the first offset comprises a first threaded portion, adapted to house a peripherally threaded closure element, and preferably the second offset comprises a second threaded portion, adapted to house a head of one of the angular locking screws.
Advantageously, said solution allows introducing the angular locking screws in a first step, leaving the surgeon the possibility to orient them in the most appropriate direction and, in a second step, to lock the inserted screw by inserting the closure element, regardless of the direction chosen for the angular locking screw in the first step.
Preferably, the glenoid coupling surface comprises a trabecular porous structure, adapted to increase the stability and osteo-integration of said glenoid component.
Still preferably, the glenoid component further comprises retentive elements protruding from the prosthetic coupling surface, preferably said retentive elements being adapted to house and retain an anatomic liner, preferably of polyethylene, which, advantageously, replicates the surface on which the humeral head articulates.
Preferably, the present invention provides for a set including a plurality of glenoid components, having respective different predetermined offsets so as to define different standard increased thicknesses, adapted to compensate for different bone deficits. Advantageously, these glenoid components provide different standard increased thicknesses, which are in particular available to the surgeon in a plurality of discrete increments (i.e. increasing of 5%, or of 7.5%, or of 10%, or yet different increments) for properly compensating the specific bone deficit encountered in a patient.
According to a further aspect of the invention, a shoulder prosthesis comprising at least one second prosthetic component and a glenoid component made according to what has been described above is provided.
Further features and advantages will become more apparent from the following detailed description of preferred, non-limiting, embodiments of the present invention, and from the dependent claims which outline preferred and particularly advantageous embodiments of the invention.
The invention is illustrated with reference to the following figures, given by way of non-limiting example, in which:
In the different figures, analogous elements will be identified by analogous reference numbers.
With reference to the enclosed Figures, reference number 100 globally indicates an embodiment of a glenoid component for a shoulder prosthesis made according to the present invention.
The prosthetic coupling surface 105 comprises a second portion 106 having a second outer edge 107 which defines a reference plane 108. The second portion 106 is preferably concave.
The glenoid component provides a predetermined offset 109 between the development plane 104 and the reference plane 108.
Furthermore, the glenoid component 100 comprises a substantially truncated cone-shaped glenoid coupling element 110, protruding from the glenoid coupling surface 101. The glenoid coupling element 110 may be made integral or removable with respect to the body of the glenoid component 100.
As visible in
In the present embodiment the glenoid component 100 comprises four through-holes 112, adapted to house fixing screws of the glenoid component 100. A recess 113 with a preferably substantially parallelepiped section at the glenoid coupling surface 101 corresponds to each hole 112. Furthermore, preferably around the glenoid coupling element 110 a circular recess 114 in connection with the recesses 113 is provided.
In
However, this exemplifying solution is only suitable for reverse prosthesis. Reverse prosthesis means a prosthesis that does not rely on the action of the rotator cuff muscles but relies on the deltoid muscle. In other words, it is a prosthesis with the head on the scapular glenoid that articulates on a spherical liner positioned on the humeral part, using the lever arm of the deltoid. This type of prostheses are used in patients with irreparable injuries of the rotator cuff with loss of function and strength of the shoulder, precisely, in which it is not possible to adopt the rotator cuff muscles to make the shoulder prosthesis work.
Furthermore, the embodiment represented in
As stated, the first portion 102 of the glenoid coupling surface 101 is convex with a curvature radius R that is constant for all of the configurations to use the same tool, which in the present case is represented by a cutter with the same curvature radius. It is therefore sufficient to orient the cutter in the correct way based on the defect. In particular,
Preferably, the glenoid component 100 is not made with angles greater than 30°, preferably not greater than 25°, to avoid mechanical strength complications of the glenoid component 100 increasing the lever arm between point of application of force and bone. Generally, to correct very severe deficits, such as with an angle of 35°, it is preferable to use a glenoid component 100 combined with a preliminary milling operation on an inclined axis, with respect to the eroded surface. However, nothing prevents the provision of a more resistant glenoid component 100 and adopting higher angles of the development plane 104.
Moreover, the increased thickness of the glenoid components shown in
The position of the convexity curvature center of the glenoid component 100 is selected, in the various configurations, in order to ensure the desired angle α and at the same time to ensure a minimum thickness of the glenoid component 100, still in order to avoid any mechanical seal problems.
In the present case with a first circular outer edge 103 and second circular outer edge 107 it is sufficient to position the thickest part of the glenoid component 100 along the direction of the bone deficit.
As stated and as most visible in
The glenoid coupling surface 801, as visible in
Moreover, the increased thickness of the glenoid components shown in
In that respect, the ‘normal’ thickness of a glenoid component is defined by an offset of about 9% of the diameter of the glenoid component, while the increased thickness of the glenoid components is defined by larger offsets, preferably larger than 15%, more preferably larger than 25%, as also exemplified with reference to
Preferably the longitudinal distance is comprised between 2 and 10 mm, more preferably comprised between 4 and 6 mm.
However, nothing prevents the use of more resistant components with different thicknesses, included in the scope of protection defined by the appended claims.
In the event that the surgeon deems it necessary to use an anatomical prosthesis and not a reverse prosthesis, for example in the case of a young patient with an intact rotator cuff, a further embodiment of glenoid component 1000 is provided, which is represented in two different variants in
In particular,
As it may be seen, this embodiment in both the represented variants provides both the first outer edge 1003 of the glenoid coupling surface 1001 and the second outer edge 1007 of the substantially oval-shaped prosthetic coupling surface 1005. Two variants are required since it is not possible to rotate the glenoid component 1000 due to asymmetry issues analogously to the embodiment with circular outer edges 103 and 107.
As this is an anatomic prosthesis, the glenoid component 1000 must be positioned vertically on the glenoid to anatomically reproduce the surface. In the case of hybrid defects, for instance upper-posterior with a 45° inclination, it is therefore necessary to select one of the two conditions, either posterior or superior, and prepare the seat with a milling operation until the defect is eliminated. Alternatively, however, it is possible to develop a dedicated glenoid component 1000 for a specific bone deficit.
Even in this embodiment the glenoid component 1000 comprises a substantially truncated cone-shaped glenoid coupling element 1010, protruding from the glenoid coupling surface 1001 and being adapted to be coupled to a bone pin 1111, and which develops along an axis that is substantially perpendicular to a un reference plane 1008. Even in this embodiment it is possible to modularly couple a bone pin 1111 of various lengths. It is possible to adopt the same glenoid component both in a configuration of the reverse type, as well as in the case of an anatomical prosthesis, since the geometry of the glenoid coupling element 1000 is similar. This is particularly useful in the event that a conversion is required, namely a transition to an implant of the reverse type after a first implant of the anatomical type.
The glenoid component 1000, as visible in
Variants with a predetermined offset 1009 configured to maintain the longitudinal distance along the perimeters of the first outer edge 1003 and the second outer edge 1007 substantially constant, in cases of central erosion, are further visible. Even in this case a range of longitudinal distance comprised between 4 mm and 6 mm is preferable, but nothing prevents from providing different longitudinal distances.
In all cases a constant curvature radius R is provided, with the same characteristics regarding the convexity curvature center described for the corresponding embodiments described above.
Retentive elements 1110 protruding from the prosthetic coupling surface 1001 are preferably further provided.
Said retentive elements 1110 are preferably adapted, as visible in
In
In case the surgeon provides for the use of an angular locking screw, an alternative embodiment 1200 is further provided as represented in
According to said embodiment, the predetermined offset 109 at the prosthetic coupling surface 105 of the glenoid component 1200 comprises a first offset 109A at the holes 112 and a second offset 109B, at the glenoid coupling element 110. The first offset 109A is preferably comprised between 1 mm and 7 mm, even more preferably between 2 mm and 4 mm. In this embodiment, it is observed that the first offset 109A represents an additional thickness, whereas the second offset 109B substantially corresponds to the entire thickness 109 of the other embodiments previously described. The first offset 109A thus acts as an additional thickness and allows introducing a locking element for the angular locking screws 1201.
The portion of the glenoid component 1200 comprising the glenoid coupling element 110 remains unchanged by not introducing any lateralization, whereas the glenoid component 100 provides an offset at the holes 112 that is configured to provide a space for poly-axial locking of the screws 1201.
As better visible in the sectional view of
The second offset 109B comprises a second threaded portion 1204 adapted to receive a head 1205 of one of the angular locking screws 1201. In the embodiment illustrated, the figures in particular represent a hemispherical head of the screw 1201 with hexagonal recess in which a related peripherally threaded closure element 1203 is inserted, said embodiment being, as stated, exemplifying and non-limiting.
Specifically, the fixing screw 1201 is oriented and screwed in the same way as the previously described embodiments, while the closure element 1203 will allow its angular locking once introduced. The closure element 1203 is thus screwed until it abuts onto the head of the angle locking screw 1201, compressing and locking it polyaxially.
Clearly, the present solution may be applied at all of the holes 112 or at a subset thereof.
In a variant, nothing prevents from providing a second non-threaded offset 109B and only providing a first threaded offset 109A, in particular in the case of not particularly accentuated angles desired for the screw 1201, angles for which the same screw 1201 is mostly protruding.
It is further possible to provide a further variant with a different locking solution, for example by adopting fixing screws with an oversized head comprising an expandable elastic element. In this case, the poly-axial locking of the screw 1201 could be obtained by expanding the elastic element within the first offset 109A, without the need for the latter to provide threaded portions.
The present invention further provides at least one shoulder prosthesis comprising a glenoid component according to one of the embodiments and variants of the invention and at least one related prosthetic component associated with the glenoid component, such as for instance the above-described anatomic liner 1113.
Advantageously, the present invention allows for a range of possibilities in correcting bone deficits with standard and tested elements as suitable for the specific clinical conditions of a patient.
Furthermore, the present invention combines peculiarities under different conditions, with different characteristics for specific bone deficits, and a universality of use in particular by providing a surface adapted to couple on the convex glenoid with constant radius, so as to allow the adoption of a single tool by of a surgeon in the preparatory phase.
Advantageously, the present invention is suitable for different conditions of bone deficits, whether due to angular erosion or due to central erosion.
Advantageously, the present invention allows optimizing time and precision of surgical operations peculiar to the shoulder.
Still advantageously, the present invention provides a relatively simple and intuitive application for a surgeon.
Still advantageously, the present invention provides for coupling with existing devices, such as bone pins, also allowing a coupling with several bone pins of various lengths with a single glenoid component.
Finally, advantageously the present invention does not have particularly complex structural characteristics, making it suitable for large-scale production, with obvious impact also from an economic point of view.
It should also be noted that the different embodiments each further present specific and peculiar advantages as described.
It is evident that, where there are no technical incompatibilities evident to the skilled person, the configurations of specific elements described with reference to certain embodiments can be used in other embodiments described herein.
For instance, it is possible to use a trabecular-porous structure 601 even in the embodiment with an oval peripheral structure.
The embodiments described herein are therefore to be understood as illustrative and non-limiting examples of the invention.
Number | Date | Country | Kind |
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102019000021432 | Nov 2019 | IT | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2020/082348 | 11/17/2020 | WO |