The present invention relates to the general technical field of medical clips suitable for exerting compression in order to compress together two bone fractions or biological tissue fractions in order to promote osteosynthesis between them, i.e. in order to ensure that they fuse together, in particular with bony fusion, said medical clip having at least two legs that extend longitudinally from a transverse bridge.
The present invention relates to a medical compression clip capable of compressing together two bone fractions and/or tendon or ligament type biological tissue fractions in order to cause them to fuse together, the clip comprising at least two legs extending longitudinally from a transverse bridge, at least one leg occupying a naturally converging position so as to form a converging leg that is directed towards the other leg, the clip being made out of a material presenting sufficient elasticity to enable the converging leg to be subjected to temporary elastic deformation away from its naturally converging position, e.g. in order to enable it to be put into place, and to return naturally towards its naturally converging position in order to exert a compression force, the clip being provided with deformation means enabling a force opposing the convergence of said converging leg to be exerted on said at least one converging leg by means of an external tool co-operating with said deformation means in order to impart temporary deformation to the converging leg, the deformation means being formed by a reception member for receiving an external tool, the reception member being arranged at the junction between said at least one converging leg and the transverse bridge.
The present invention also relates to a kit formed by a medical compression clip and by a tool suitable for co-operating with the clip in order to put it into place.
It is already known to have recourse to medical compression clips for holding bone fragments in contact with one another in order to achieve progressive osteosynthesis between them, i.e. bony fusion by cell growth at the interfaces between the bony fragments.
In conventional manner, the bone fractions that result from accidents that have led to bones breaking are firstly put back into place by a surgeon, and they are then put into contact with one another and held in contact with one another along fracture interfaces by means of clips.
In known manner, clips are generally in the form of two legs extending longitudinally from a transverse bridge so as to form a U-shaped clip. After making two substantially coplanar and parallel holes in respective ones of the bone fractions between which bony fusion is to be achieved, the surgeon inserts each of the legs of the clip in the holes until the transverse bridge comes to rest on the outside surfaces of the bone fractions. This makes it possible to hold the two bone fractions to be fused together in contact for a length of time that is sufficient to allow cell growth and bony fusion to take place.
Clips of the above-mentioned type generally give satisfaction and make it possible to ensure that bony fusion ultimately takes place between the bone fragments.
Nevertheless, it is found that prior clips suffer from a drawback associated with the time needed to achieve complete bony fusion. The time is generally considered as being long and it is associated with the difficulty of putting the two bone fragments into contact with each other with sufficient pressure to encourage rapid growth of bone cells. It is difficult to put conventional prior art clips of U-shape with parallel legs correctly into place and it is also difficult to obtain sufficient contact pressure between the two bone fragments in order to lead rapidly to good bone fusion.
Consequently, the objects given to the invention seek to remedy the various above-mentioned known drawbacks of the prior art and to propose a novel medical compression clip that is capable of easily generating compression between bone fractions or biological tissues to be fused one against the other when the clip is inserted in said bone fractions or biological tissues.
Another object of the invention seeks to propose a novel medical compression clip that can easily be put into place by a surgeon, while also being capable of exerting compression on bone fractions.
Another object of the invention seeks to propose a novel medical compression clip that can exert compression on bone fractions to be fused together, while also being particularly robust and presenting good fatigue strength.
Another object of the invention seeks to propose a novel medical compression clip that can be put into place by a surgeon, while not harming the original mechanical properties of the clip.
Another object of the invention seeks to propose a medical device constituted by a clip comprising a clip and a member for putting the clip into place, which member enables a medical compression clip to be put into place easily.
The objects given to the invention are achieved with the help of a medical compression clip capable of compressing together two bone fractions and/or tendon or ligament type biological tissue fractions in order to cause them to fuse together, the clip comprising at least two legs extending longitudinally from a transverse bridge, at least one leg occupying a naturally converging position so as to form a converging leg that is directed towards the other leg, the clip being made out of a material presenting sufficient elasticity to enable the converging leg to be subjected to temporary elastic deformation away from its naturally converging position, e.g. in order to enable it to be put into place, and to return naturally towards its naturally converging position in order to exert a compression force, the clip being provided with deformation means enabling a force opposing the convergence of said converging leg to be exerted on said at least one converging leg by means of an external tool co-operating with said deformation means in order to impart temporary deformation to the converging leg, the deformation means being formed by a reception member for receiving an external tool, the reception member being arranged at the junction between said at least one converging leg and the transverse bridge, the clip being characterized in that the reception member is arranged within the transverse bridge in such a manner that the external tool, of the pin or rod type, can bear against and along said converging leg in order to impart the temporary elastic deformation.
The objects given to the invention are also achieved by a kit constituted by a medical compression clip in accordance with the invention and by a tool suitable for co-operating with the clip to impart temporary elastic deformation thereto.
Other features and advantages of the invention appear and can be seen in greater detail on reading the following description made with reference to the accompanying drawings that are given solely by way of non-limiting illustrative example, and in which:
As shown in the figures, the invention relates to a medical compression clip 1 capable of compressing two bone fractions and/or two biological tissue fractions such as tendons or ligaments in order to ensure osteosynthesis between them.
Thus, the medical compression clip 1 in accordance with the invention may be put into place in order generally to ensure bone fusion between two bone fractions or fusion between two ligaments or indeed two tendons, or even between a bone fraction and a ligament or a bone fraction and a tendon, without thereby going beyond the ambit of the invention.
As shown generally, the medical compression clip 1 of the invention comprises two legs 2 and 3, each having a distal end 2D, 3D and a proximal end 2P, 3P, which distal ends are connected together by a transverse bridge 4.
Thus, the medical compression clip 1 of the invention has at least two legs 2 and 3 extending longitudinally from the transverse bridge 4 so as to form generally a two-branch U-shaped clip.
According to an important characteristic of the invention, the medical compression clip 1 of the invention has at least one leg 2 that occupies a naturally converging position, thus forming a converging leg 2 that is directed towards the other leg 3, the clip being made of a material that presents sufficient elasticity for the converging leg 2 to be capable of being subjected to temporary elastic deformation away from its naturally converging position, e.g. in order to enable it to be put into place, and to be capable of returning naturally towards its naturally converging position in order to exert a compression force by virtue of its intrinsic elasticity.
In the variant embodiment shown in
In this position, and in a variant that is not shown in the figures, the non-converging leg 3 then forms, at rest, a right angle with the transverse bridge 4, with only the leg 2 forming a leg that converges at rest.
Thus, without going beyond the ambit of the invention, the medical compression clip 1 in accordance with the invention may include at least one converging leg 2 or two converging legs 2 and 3.
In the description below and in the accompanying drawings, the variant embodiments of the medical compression clip 1 in accordance with the invention are all shown, for simplification purposes, as having two converging legs 2 and 3, without the subject matter of the invention being limited thereby to the presence of two converging legs 2 and 3.
The medical compression clip 1 in accordance with the invention is made from a material such as polyetheretherketone (PEEK) or out of a metal material such as titanium, presenting sufficient elasticity for the converging leg(s) 2, 3 to be deformed or spaced apart from the natural rest position on being subjected to temporary elastic deformation, e.g. in order to reach the position shown in dashed lines in
Thus, a medical compression clip 1 is made available that enables the surgeon to deform clips in accordance with the invention very easily and in temporary manner so as to make the legs 2 and 3 substantially coplanar and parallel, and then put the legs 2 and 3 into holes previously formed in the fragments of bone or biological tissue to be fused together, after which the spacing-apart force can be released so as to allow the clip to close, thereby compressing the two fragments of bone and/or biological tissue such as tendons or ligaments.
As shown in the figures, the deformation means 10 are formed by a reception member for receiving the external tool 20, the reception member being arranged within the transverse bridge 4 at the junction between said at least one converging leg 2, 3 and the transverse bridge 4.
Advantageously, the reception member is formed by at least one through orifice 11 formed through the thickness of the transverse bridge 4, as shown in the variant of
Thus, each through orifice 11 is formed through the thickness of the transverse bridge 4 so as to open out in the vicinity of the proximal end 2P and/or 3P of each converging leg 2, 3 and at the peripheries of said legs.
In this way, the external tool 20, such as a pin 21, can be engaged axially in said through orifice 11 and can slide, e.g. along the inside face 8 of the leg 2, 3, e.g. at least as far as the distal end 2D, 3D.
This arrangement enables the surgeon to exert an elastic deformation force on each converging leg 2, 3 in question by causing the pin 21, that bears against fractions of the inside faces 8 of the through orifice 11 or of the open cutout 12, to pivot towards the inside of the clip, i.e. towards the plane of symmetry S.
In order to provide a bearing area that facilitates deformation without that creating fatigue zones within the clip, each converging leg 2, 3 is advantageously provided on its inside face 8 with a reception groove 8A for receiving the external tool 20, which groove is of section that is complementary to the section of the external tool, said groove 8A extending the through orifice 11 or the open cutout 12.
As shown, and solely as a variant, the groove 8A presents a cross-section that is curved and of size similar to the cylindrical section of the external member 20.
In particularly advantageous manner and in order to reinforce the robustness of the clip and enable the converging legs 2, 3 to be deformed elastically while generating minimum fatigue in the material constituting the clip, the through orifice 11 or the open cutouts 12 are shaped so as to enable the external tool 20 to bear linearly while imparting the temporary elastic deformation.
In a particularly advantageous variant of the invention as shown in
As shown in
The same arrangement is used for the semi-conic cross-section of the open cutout 12 where the larger half-diameter is flush with the top surface 4A.
Because of this geometrical arrangement, the external member 20 comes to bear in linear manner solely against a fraction of the larger diameter or a fraction of the larger half-diameter as defined above, thereby greatly reducing the forces exerted on the converging leg while it is being spaced outwards, thereby preserving its elasticity.
According to a particularly advantageous characteristic of the invention, the cone angle α of the conic cross-section or of the semi-conic cross-section is substantially equal to the angle of convergence β of said at least one converging leg 2, 3.
The convergent angle β and the cone angle α may for example lie in the range 2 degrees to 20 degrees, e.g.
being about 5 degrees.
By selecting these specific angles, it is possible to avoid creating stress zones in the shoulders of the clip.
According to another advantageous characteristic of the clip of the invention, the transverse bridge 4 is substantially curved when the clip is in its rest configuration so as to enable it to be rectilinear when the legs 2 and 3 are substantially mutually parallel and coplanar.
In this variant embodiment (not shown in the figures), the curvature of the transverse bridge 4 presents, at rest, a bottom face 4B that is concave, with the top face 4A then being convex.
As also shown in the figures, the legs 2 and 3 of the clip are advantageously of different lengths, the leg 2 being shorter than the leg 3, for example. This arrangement makes it easier for the surgeon to insert the legs 2 and 3. Nevertheless, it is possible for the legs 2 and 3 to be of equal length.
Thus, in the preferred variant embodiments shown in
In the variant shown in
It is also possible to envisage making a clip of the invention with three or four or even more converging legs without going beyond the ambit of the invention.
As shown in the figures, each leg may be provided with a set of teeth 15 forming a double serie of teeth 15, e.g. situated on either side of the groove 8A with the teeth being arranged one above another along the entire length of the converging leg(s) 2, 3.
The teeth 15 enable the clip to be held better in place, and in particular they avoid the clip escaping from the housings in which it is inserted within the bone mass or the biological tissue.
The present invention also relates to a kit formed firstly by a medical compression clip 1 as described above and secondly by an external tool 20 suitable for co-operating with the clip in order to deform it elastically and temporarily.
In an advantageous version of the invention, the kit including the medical compression clip 1 as described above constitutes a medical device and it may be formed by at least one external tool 20 of the pin or rod type 21 that is to co-operate with the deformation means 10 for deforming the clip in order to deform it elastically and temporarily.
As shown in
The pins 21 or rods in accordance with the invention may be made of metal materials and they may be of any section, preferably of circular section, and in any event of a section that matches the section of the groove 8A so as to be able to bear over an area on the converging leg(s) 2, 3.
In order to put the clip of the embodiment variant shown in
The branches 26 of the external tool 20 are preferably designed to be inserted in the open cutouts 12 so that said branches 26 are embedded in the converging leg(s) 2, 3, the open cutouts 12 being designed to surround said branches 26, at least in part.
The invention also provides a method of implanting a medical compression clip in accordance with the invention, the method comprising the following successive steps:
In the invention, the temporary deformation of the converging leg(s) 2, 3 is thus imparted by moving the converging legs 2, 3 apart so as to cause them to occupy a position in which they are substantially orthogonal or perpendicular to the extension plane that contains the transverse bridge 4.
In this position, the clip can easily be inserted in the holes previously made by the surgeon, and insertion can be made even easier if the clip has two converging legs 2, 3 of unequal lengths.
In this situation, the surgeon can indeed begin by inserting one leg only in its hole without it being immediately necessary to bring both converging legs 2 and 3 into alignment facing each of the holes.
In the invention, deformation is performed with the help of an external tool 20 that bears against the clip and on the inner or outer surfaces of the converging legs 2, 3 in order to space them apart.
Finally, in the invention, the external tool 20 is engaged in through orifices 11 or in open cutouts 12 formed in the clip so as to bear all along the converging leg(s) 2, 3 in order to impart temporary elastic deformation to the leg in question of the clip.
In the invention, once the surgeon releases the force exerted on the external tools 20, the medical compression clip 1 in accordance with the invention immediately recloses because of the intrinsic internal elasticity of each of the converging legs 2, 3, thereby contributing to put the two bone fragments or the biological tissues immediately into compression.
The invention finds its industrial application in the design, the implementation, and the fabrication of medical clips for compressing bone fragments and/or biological tissues.
Number | Date | Country | Kind |
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1261733 | Dec 2012 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/FR2013/052970 | 12/6/2013 | WO | 00 |