Patent Application
20210045886
The present invention relates to an implant for the gleno-humeral or shoulder joint.
More precisely, the present invention relates to an implant for the correction of gleno-humeral instability.
The gleno-humeral or shoulder joint is the point of articulation between the glenoid cavity of the scapula and the head of the humerus, which allows a wide range of movements of the upper limb.
The physiognomy that allows this wide range of movements causes a relative instability of the joint.
In its chronic form, gleno-humeral instability represents a pathology that is difficult to understand and solve. The majority of diagnostic studies and anatomopathological surveys have demonstrated that there exists a bone defect of the glenoid in over 80% of the cases of chronic anterior instability.
In order to definitively solve the problem, the surgeon must undertake to correct the glenoid defect with a bone graft. Bone grafts can be homologous, autologous and heterologous. They can be harvested from structures neighbouring the shoulder or at a distance.
All of the scientific literature is in agreement as to the necessity of repairing this defect in the most anatomical way possible, but this particular aim cannot always be achieved without altering the patient's anatomy.
If a piece of autologous bone is used, a second surgical intervention in the same patient will be necessary in order to harvest it.
If an allograft from a donor is used, it will be necessary to rely on bone banks, with all the problems tied to this type of procurement.
In both the former and latter cases, the operating time will be increased and the graft will never be standardized in its form, because it must be cut freehand by the surgeon at the time of the intervention.
In the case of a heterologous bone graft, there are no available data in this regard for application on the glenoid for anterior or posterior instability, which the scientific literature is very critical toward. Even for autologous grafts, taken from neighbouring structures or from the iliac crest, there are no certainties with respect to osteointegration, especially if they are composed of only bone and thus lacking a vascular peduncle. In fact, in all of the cases already experimented with and applied in shoulder surgery, the transfer of bone from the iliac crest takes place freely, that is, without a vascular peduncle grafted on another vessel to enable a direct supply of the transplanted piece of bone.
To date, no prosthetic solutions for the correction of the defect itself have been described. The problems are tied to the survival of heterologous tissues and the antigenic reaction of the host macrophages, which would destroy the active antigenic parts present on the graft. In the case of mineral scaffolds, the difficulty up to now has been to create the means of stability.
The aim of the present invention is to develop an implant to correct the glenoid defect, which allows the problems of the prior art to be solved by means of a solution that may be optimally adapted to the patient's anatomy.
Furthermore, the aim of the present invention is to provide an implant that may be easily and quickly produced, so as to be available in shorter times and at reduced costs.
In addition, the aim of the present invention is to obtain an implant that is quickly and effectively osteointegrated, for a faster recovery of the patient.
The object of the present invention is an implant for the correction of gleno-humeral instability, in particular for the correction of the glenoid defect of the glenoid of a patient, said implant having a substantially “J” shape with a wedge portion substantially transversal to a substantially flat portion, said wedge portion being suitable for being inserted into the bone channel obtained in the glenoid of a patient, said substantially flat portion being suitable, when said implant is in use, for being placed at the site of the glenoid defect in contact with the external bone portion of the glenoid of a patient, said implant being characterized in that it comprises a first element made of organic material corresponding at least to the flat portion of the implant, and a second element made of a rigid biocompatible material corresponding to at least the wedge portion of the implant and coupled to said first element.
In particular, according to the invention, the organic material of the first element can be a biocompatible material which is suitable for being inhabited by bone cells from the glenoid bone, so as to facilitate the stabilization of the implant.
Again according to the invention, the organic material of the first element can be a biological or mineral material; in particular it is a bone material, preferably a heterologous deproteinized bone material.
Likewise according to the invention, said second element can be made of a porous or non-porous biocompatible material, or biocompatible metal such as titanium or tantalum.
Furthermore, according to the invention, said second element can have at least one rough surface in the wedge portion of the implant, so as to facilitate the grasp of the implant on the bone channel.
Moreover, according to the invention, the first element can have a “J” shape having a flat portion and a wedge portion substantially transversal to said flat portion.
According to the invention, said second element can preferably be a sheath that, when coupled to the first element, at least partially overlaps the wedge portion of the first element.
Again according to the invention, said sheath can have a mesh or a grid that forms said rough surface.
Likewise according to the invention, the first element can correspond to the flat portion of the implant, the second element can correspond to the wedge portion of the implant, wherein the second element can be coupled to the first element by means of coupling means.
Furthermore, according to the invention, the coupling means can be pins present in said second element and suitable for being inserted in respective holes obtained in the first element.
Again according to the invention, the second element can have a plurality of holes making up the rough surface of the second element.
Preferably, according to the invention, the rough surface in the wedge portion of the implant can be obtained by knurling.
In particular, according to the invention, the wedge portion of the implant can be substantially curved to ensure a more effective grasp on the bone channel wherein it is inserted.
Furthermore, according to the invention, said implant can have a first hole in the flat portion, suitable for allowing the passage of a stabilization thread for the stabilization of the implant.
Finally, according to the invention, said implant can have a second hole in the wedge portion suitable for allowing the passage of a traction thread to facilitate the insertion of the implant into the glenoid channel.
The invention will now be described by way of illustration and not by way of limitation, with particular reference to the drawings of the appended figures, wherein:
Making reference to
Said implant 1 has a “J” shape having a wedge portion 2 transversal to a substantially flat portion 3. As shown, for example, in
Furthermore, said implant 1 comprises a first element 4 made of organic material at least in the flat portion 3 of the implant 1.
For organic material, reference can be made to a biological or mineral material, such as, for example, bone material, for example heterologous deproteinized bone material or any other biocompatible material that can be inhabited by bone cells from the glenoid bone, so as to facilitate the stabilization of the implant 1.
Said bone portion is in particular of a heterologous type, and can be previously profiled and standardized in shape and size. For example, the preferred sizes can be a length of 2 cm, width of 8 cm and thickness of 15 mm.
As shown in
Furthermore, the implant 1 provides for a second element 5 made of rigid biocompatible material and coupled to said first element 4. Said second element 5 being preferably made of rigid biocompatible material, for example pyrocarbon, or tantalum or another porous or non-porous biocompatible material, or biocompatible metal such as titanium or tantalum, so as to improve the possibility of stabilization, synthesis and osteointegration of the implant 1 with the glenoid being operated on.
In particular, this enables greater stability and the possibility for the first element 4, in particular the bone component thereof, to have time to adapt itself.
Said second element 5 has at least one rough surface in the wedge portion 2 of the implant 1, which facilitates the grasp of the implant 1 on the bone channel Cg.
As shown in the figures, the implant 1 has holes 6, 12, a first hole 6 obtained in the flat portion 3 and a second hole 12 obtained in the wedge portion 2.
As shown in the
The second hole 12 allows the passage of a further thread or traction thread 13 necessary for the insertion of the implant 1 at the site of the glenoid defect to be repaired; it thus serves temporarily to draw, once passed posteriorly to the scapula, the flat portion 2 into the opening Cg for the penetration thereof into the glenoid bone G.
The bone channel Cg obtained in the glenoid bone G is preferably oriented by 30° relative to the passage channel Cp of the traction thread 13. The bone channel Cg preferably has a diameter equal to 2.8 mm.
The process for the insertion of the implant according to the invention provides for the following steps:
a) use of a cannula with a dedicated shape, preferably with a 16 mm diameter, to be inserted through the rotator interval;
b) use of a pin with a rear eye for the passage of a medial guide thread;
c) use of a guide for the hole Cp parallel to the glenoid surface for the passage and stabilization of the implant 1 with the button 8;
d) use of a dedicated curved scalpel with a thin wedge shape at the start of the blade, then increasing in thickness, to fashion the glenoid opening at an angle of about 100° relative to the glenoid surface;
e) insertion of the implant 1 in the glenoid opening fashioned,
f) stabilization of the rigid element of the implant by pulling in the slot by the guide thread 13, which is oblique by 100°, and by the rough wedge 2 itself, which becomes implanted in the slot Cg fashioned in the glenoid cavity G with the suitably designed curved scalpel, and by the button 8 with non-resorbable thread 7, which passes in the tunnel Cp parallel to the glenoid surface made with the rear guide and rear button 8,
g) once inserted into the glenoid slot, the implant is impacted with a special curved tamp and is definitively stabilized by tying the thread 7 on it with a dynamometer.
In
The sheath 5 consists of a mesh or metal grid that thus has a rough surface which improves the adhesion of the wedge portion 2 with the bone channel Cg into which the implant 1 is inserted.
In
As shown for the embodiment in
In reference to
Furthermore, the second element 5 has holes 11 that make up the rough surface of the second element 5.
In
The implant 1 according to the embodiment in
This geometry can also be provided for the other embodiments described.
In conclusion, the hybrid implant according to the invention, in the embodiments described, enables to solve different problems tied to various weak points of everything that has been described up to now in the scientific literature regarding the use of bone grafts.
The implant according to the invention can be implanted by minimally invasive arthroscopy with maximum safety because the second element made of biocompatible material is in the wedge portion of the implant, thus reducing the risk of breakage of the bone portion during implantation.
Furthermore, the implant according to the invention intrinsically has a greater stabilizing capacity than prior art grafts, since a portion of the first element of the implant is wedged in the slotted glenoid bone, reinforced by the second element made of rigid osteoinductive material.
Moreover, the implant according to the invention, with respect to what has been described for correcting the glenoid defect, has the following advantages:
Furthermore, the implant according to the invention increases graft-glenoid cavity synthesis compared to the old systems, leaving the function of temporary protection of the underlying structure and of transport up to the button resting on the bone part.
In the foregoing, the preferred embodiments have been described and variants of the present invention have been suggested, but it is to be understood that a person skilled in the art may introduce modifications and changes without going outside the scope of protection, as defined by the appended claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 102018000002734 | Feb 2018 | IT | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IT2019/050029 | 2/13/2019 | WO | 00 |
