TELESCOPIC NAIL AND ASSOCIATED PERFORATING TOOL

Abstract

Telescopic nail (2) for the treatment of fractures or deformations of long bones, as for example in the case of osteogenesis imperfecta or pseudo-arthrosis. comprising: a hollow stem (2); a rod (10) telescopically inserted into said hollow stem (2); a first fastening element (20) coupled to an end of said hollow stem (2) for fixing to a first long bone end; a second fastening element (30) coupled to an end of said rod (10) for fixing to a second long bone end.

Advantageously, one end of said hollow stem (2) is provided with coupling means (40) for coupling to an end of a tool which can be inserted into a cavity formed in the bone for insertion of the nail.

Claims

1-11. (canceled)

12. A telescopic nail for treatment of long bones, comprising: a hollow stem; a rod telescopically inserted into said hollow stem; a first fastening element coupled to one end of said hollow stem for fixing to a first long bone end; a second fastening element coupled to an end of said rod for fixing to a second long bone end; an opposite end of said hollow stem being provided with a threaded coupling configured to couple to an end of a tool which can be inserted into a cavity formed in the bone for insertion of the nail; and wherein said first fastening element is structured as a screw with a shank to be coupled to said one end of said hollow stem and a fixing head for fixing to the bone.

13. The telescopic nail according to claim 12, wherein said threaded coupling is present also at said one end of said hollow stem.

14. The telescopic nail according to claim 13, wherein said threaded coupling is an internally threaded end of said stem for receiving, by means of screwing, an external thread of a coupling end of said tool.

15. The telescopic nail according to claim 12, wherein shank of said screw comprises an external thread that may be coupled to one or the opposite internally threaded end of said hollow stem.

16. The telescopic nail according to claim 12, wherein said second fastening element is fixed of formed as one piece construction to one end of said rod.

17. The telescopic nail according to claim 12, wherein said fixing head comprises a threaded head portion suitable for being gripped within the bone; said threaded head portion having a conical profile with a taper angle (a) of 145°±20%.

18. The telescopic nail according to claim 12, wherein said fixing head comprises a threaded head portion suitable for being gripped within the bone; said threaded head portion having a conical profile with a height (H) of 3 mm±20%.

19. The telescopic nail according to claim 12, wherein said second fastening element comprises a fixing head designed to be fixed to the bone.

20. The telescopic nail according to claim 19, wherein said fixing head comprises a threaded head portion suitable for being gripped within the bone; said threaded head portion having a conical profile with a taper of 145°±20%.

21. The telescopic nail according to claim 19, wherein said fixing head comprises a threaded head portion suitable for being gripped within the bone; said threaded head portion having a conical profile with a height of 3 mm±20%.

22. The telescopic nail according to claim 12, wherein said fixing head comprises: an internal movement cavity designed to be fixed to an end of an axial movement tool; and at least a recessed seat designed to provide a form fit coupling with an end of a maneuvering tool, said recessed seat being formed on the outside of said internal movement cavity so as to allow simultaneous coupling of said axial movement tool and said maneuvering tool.

23. A perforating tool comprising: a perforating end designed to form inside a long bone a cavity for the insertion of a telescopic nail; a coupling end disposed opposite to said perforating end and comprising a counter-coupling means couplable with a corresponding coupling means of an end of said hollow stem of the telescopic nail according to claim 12.

24. Assembly comprising: a telescopic nail according to claim 12; and a perforating tool according to claim 21.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0081] The present description makes reference to the attached drawings in which:

[0082] FIG. 1 shows a perspective and schematic view of an embodiment of a telescopic nail provided in the accordance with the present invention, in the assembled condition;

[0083] FIG. 2 shows a schematic perspective view of the telescopic nail according to FIG. 1, in the disassembled condition;

[0084] FIG. 3 shows a schematic perspective view of a hollow stem of the telescopic nail according to FIG. 1;

[0085] FIG. 4 shows a schematic perspective view of the hollow stem according to FIG. 3, cross-sectioned along a longitudinal plane;

[0086] FIG. 5 shows a schematic perspective view of a rod of the telescopic nail according to FIG. 1;

[0087] FIG. 6 shows a schematic perspective view of a detail of the telescopic nail according to FIG. 2;

[0088] FIG. 7 shows a schematic perspective view of a first fastening element of the telescopic nail according to FIG. 2;

[0089] FIG. 8 shows a longitudinal section through the first fastening element according to FIG. 7;

[0090] FIG. 9 shows a schematic perspective view of an alternative embodiment of the first fastening element;

[0091] FIG. 10 shows a schematic perspective view of a detail of the telescopic nail according to FIG. 1;

[0092] FIG. 11 shows a schematic perspective view of a detail of the telescopic nail with an alternative embodiment of the second fastening element;

[0093] FIG. 12 shows a schematic perspective view of a detail of the second fastening element according to FIG. 11;

[0094] FIG. 13 shows a schematic perspective view of a first embodiment of a perforating tool provided in the accordance with the present invention;

[0095] FIG. 14 shows a schematic perspective view of the coupling end of the tool according to FIG. 13;

[0096] FIG. 15 shows a schematic perspective view of a second embodiment of a perforating tool provided in the accordance with the present invention;

[0097] FIG. 16 shows a schematic perspective view of the coupling end of the tool according to FIG. 15;

[0098] FIG. 17 shows a schematic perspective view of the assembly comprising the telescopic nail according to FIG. 1 and the tool according to FIG. 13, coupled together;

[0099] FIG. 18 shows a schematic perspective view of a tightening tool which can be used to screw the first and/ or second fastening element of the telescopic nail according to FIG. 1;

[0100] FIG. 19 shows a cross-section along a longitudinal plane of the tool according to FIG. 18;

[0101] FIG. 20 shows a schematic perspective view of an axial movement tool which can be coupled to the first and/or second fastening element of the telescopic nail according to FIG. 1;

[0102] FIG. 21 shows a schematic perspective view of a system comprising the tools according to FIGS. 18 and 20 coupled to the telescopic nail according to FIG. 1;

[0103] FIG. 22 shows a detail of FIG. 21;

[0104] FIG. 23 shows the perforating tool according to the invention during the start of the step for forming the cavity for inserting the telescopic nail inside a deformed thigh-bone;

[0105] FIG. 24 shows the perforating tool according to FIG. 23 being advanced along the bone after the execution of a first osteotomy;

[0106] FIG. 25 shows the perforating tool completely inserted inside the thigh-bone;

[0107] FIG. 26 shows the perforating tool according to FIG. 25 with, coupled thereto, the hollow stem of the telescopic nail according to the invention;

[0108] FIG. 27 shows a telescopic nail according to the invention partially inserted inside the thigh-bone with the fastening elements not fixed;

[0109] FIG. 28 shows the telescopic nail according to FIG. 27 completely inserted inside the thigh-bone with the fastening elements fixed to the bone;

[0110] In the different figures, similar elements will be identified by similar reference numbers.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0111] With reference to the attached figures, non-limiting explanatory embodiments of the telescopic nail and the perforating tool according to the present invention are described below.

[0112] The telescopic nail according to the invention is particularly suitable, albeit not exclusively, for the treatment of fractures or deformations of long bones, as for example in the case of osteogenesis imperfecta or pseudo-arthrosis, in particular in paediatric patients.

[0113] The telescopic nail 1 generally comprises a hollow stem 2 and a rod 10 which can be slidably inserted inside an internal cavity 3 of the stem 2, thus forming a telescopic coupling.

[0114] In the explanatory embodiments, this telescopic coupling has a cylindrical shape, namely the rod has a circular cross-section and is inserted inside a tubular stem with a slightly larger diameter.

[0115] This type of profile has been envisaged since it has the advantage of ensuring a high contact area which limits the friction during the relative sliding of the components 2, 10 also during any bending and twisting of the nail during the treatment. Other types of profile, such as splined profiles, which are used in the sector are instead prone to seizing.

[0116] The telescopic nail 1 also has a first fastening element 20 designed to be removably fixed to one of the first and second stems ends 4, 5 and in turn to fix the hollow stem 2 to an end of the bone.

[0117] A second fastening element 30 is placed at a first rod end 11 and is designed to fix the rod 10 to an opposite end of the bone. This second fastening element 30 is preferably formed as one piece with the rod 10, but may be made separately and then fixed to the end 11 of the rod 10 (see FIGS. 10, 11) for example by means of welding.

[0118] As will be explained more fully in the continuation of the description, the hollow stem 2 has at the first stem end 4 coupling means 40 designed to be coupled to corresponding counter-coupling means 540 of a perforating tool 500.

[0119] In the preferred embodiments described here, these coupling means 40 are present also at the second stem end 5 and consist of an internal thread 31 formed inside the internal cavity 3.

[0120] The first fastening element 20 consists instead of a first screw comprising a fixing head 22 designed to be fixed to the bone and a first shank 21 designed to be coupled with a stem end 4, 5.

[0121] In particular, the first shank 21 comprises an external thread 21a complementing the internal thread 31 of the stem end 4, 5. This first shank 21 may also terminate in a conical engaging portion 21b for facilitating centring of the screw during insertion inside the internal cavity 3 of the stem 2 and subsequent engagement with the internal thread 31.

[0122] The fixing head 22 also has a threaded head portion 22a having a conical shape, or rather frustoconical shape, with a taper angle a, defined as being the angle between the stem and the conical surface, and a height H.

[0123] The thread of the threaded portion 22a may be interrupted by an anti-screwing groove 22c provided so as to increase the stability of fixing to the bone.

[0124] Advantageously, the threaded head portion 22a has a pronounced conical form so as to ensure a firm grip in a small bone thickness. Differently from the threaded ends of the nails according to the prior art, which have extensive threads penetrating into the growth cartilage, this pronounced conical form allows stable fixing to be obtained with a thread having a small length so as not to interfere with the growth cartilage.

[0125] In particular, the pronounced conical form is defined by a taper angle a of 145°±20% and a height H of 3 mm±20%. More preferably, a is equal to 145°±10% and H is equal to 3 mm±10%. Even more preferably, a is equal to 145° and H is equal to 3 mm.

[0126] The fixing head 22 may also have an internally threaded cavity 50 accessible from the outside via the top surface 23 of the fixing head 22. A corresponding threaded end 650 of an axial movement tool 600, such as for example that shown in FIG. 20, can be inserted by means of screwing inside the internally threaded cavity 50. As can be seen from this figure, the threaded end 650 is in particular located at the apex of a movement bar 601 which has at the opposite end to the threaded end a movement handgrip 602.

[0127] The thread of the cavity 50 is cylindrical as shown in FIG. 8. A chamfer for facilitating the introduction of the tool may also be present.

[0128] A recessed seat 51, 51′ shaped so as to provide a form-fit coupling with an end of the manoeuvring tool 700, such as that for example shown in FIGS. 18 and 19, is also formed in the top surface 23. The recessed seat 51, 51′ is advantageously formed on the outside of the internally threaded cavity 50 so as to leave free access to the internally threaded cavity 50 and allow the simultaneous coupling of the manoeuvring tool 700 with the recessed seat 51 and of the axial movement tool 600 with the internally threaded cavity 50.

[0129] The manoeuvring tool 700 may comprise a manoeuvring bar 701 having a manoeuvring end 702 shaped so as to provide a form-fit coupling with the recessed seat 51 and an opposite manoeuvring handgrip 703. This manoeuvring tool 700 is advantageously cannulated, namely has a guide cavity 704 which extends over the whole length of the tool and inside which the movement bar 601 of the axial movement tool 600 can be inserted in a freely rotatable and displaceable manner.

[0130] In particular, the recessed seat 51 may have a transverse groove which extends outside of the internally threaded cavity in opposite radial directions with respect to the longitudinal axis of the screw (see FIGS. 6 and 7).

[0131] The example a manoeuvring tool 700 shown in FIG. 18 has a manoeuvring end 702 with manoeuvring teeth 705 which are aligned and located in a diametrically opposite position with respect to the longitudinal axis of the cavity and can be engaged inside the recessed seat 51 in order to transmit a screwing torque.

[0132] FIG. 9 shows an alternative embodiment of the first fastening element 20′ which differs in that it has an almost entirely threaded shank and a recessed seat 51′, suitable for an Allen key, formed above the internally threaded cavity 50. A manoeuvring end which instead of the manoeuvring teeth has a hexagonal-profile tip crossed by the guide cavity may be used for insertion inside the recessed seat 51′ in order to transmit a tightening torque to the screw.

[0133] The second fastening element 30 preferably also has a fixing head 22 such as that described above in connection with the first fastening element 20.

[0134] The assembly consisting of the axial movement tool 600 inserted inside the manoeuvring tool 700 may therefore be coupled with the fixing head 22 of the first or second fastening element 20, 30 (see FIG. 21) and be used to perform a series of operations.

[0135] In particular, once the second fastening element 30 has been stabilized by screwing the threaded end 650 of the movement bar 601 into the internally threaded cavity 51 the rod 10 of the telescopic nail 1 may be inserted into the bone, the second fastening element 30 screwed into the bone after inserting the manoeuvring end 702 into the recessed seat 51, and if necessary extraction or insertion of the nail performed by means of the movement tool 600, for example during removal of the nail.

[0136] The aforementioned assembly may also be used to guide the insertion and screw the shank 21 of the first fastening element 20 into a stem end 4, 5 and, once stabilized, to guide the movements of the stem 2 and screw the first fastening element 20 into the bone.

[0137] With reference to FIGS. 13-17, explanatory non-limiting embodiments of the perforating tool 500, 500′ will now be described.

[0138] Differently from the perforating tools according to the prior art, the perforating tool 500, 500′ according to the present invention comprises a coupling end 501, opposite to a perforating end 502, shaped so as to remove bone tissue during the formation of the nail insertion cavity and comprising counter-coupling means 540 designed to be coupled to the coupling means 40 of a stem end 4, 5 of the hollow stem 2 of the telescopic nail 1.

[0139] The perforating tool 500, 500′ comprises in particular a guide bar 503 extending between the coupling end 501 and the perforating end 502, the latter have a shape known per se.

[0140] In the embodiment shown in FIG. 14, the counter-coupling means 540 consist of an end-piece provided with an external thread 541 which can be fixed by means of screwing inside the internal thread 31 of one of the stem ends 4, 5.

[0141] Alternative embodiments may envisage different types of coupling means and counter-coupling means.

[0142] FIGS. 13 and 25 show a first embodiment of the perforating tool 500 which has a length greater than the long bone inside which it must be inserted.

[0143] A second embodiment of the perforating tool 500′, shown in FIGS. 15 and 16, may advantageously have a smaller length than that of the long bone inside which it must be inserted, so as to simplify the implant operations and reduce the instruments needed to perform such an implant, as will emerge more clearly below.

[0144] Both the perforating tool 500, 500′ and the hollow stem 2 of the telescopic nail 1 may have lateral milled zones 70 which allow the perforating tool to be stabilized on and removed from the said nail.

[0145] The telescopic nail 1 may be advantageously implanted in the long bone of a patient in a secure and effective manner compared to the nails of the prior art owing to the use of the perforating tool according to the invention.

[0146] For explanatory purposes, with reference to FIGS. 23-28, a method for implanting the telescopic nail 1 in a deformed thigh-bone 800, which uses the perforating tool 500, is described below.

[0147] Firstly, the perforating end 501 of the perforating tool 500 is inserted into the distal end 801 of the thigh-bone 800 and the perforating tool 500 is gradually advanced so as to form an internal cavity for inserting the telescopic nail 1. At the same time osteotomies may be carried out for alignment of the bone.

[0148] The perforating tool 500 is advanced until the perforating end 502 emerges from the proximal end 802 of the bone, leaving the coupling end 502 outside of the distal end 801 of the bone (FIG. 25).

[0149] The second rod end 12 of the rod 10, opposite to the second fastening element 30, is inserted into the internal cavity 3 of the hollow stem 2 by means of the second stem end 5.

[0150] The first stem end 4 of the hollow stem 2 of the telescopic nail 1 is coupled by means of screwing to the coupling end 502 of the perforating tool 500 (FIG. 26) and the perforating tool 500 extracted from the proximal end 801 of the bone, being drawn along behind the hollow stem 2 until the first stem end 4 emerges form the proximal end 802 of the bone. During this latter step, the rod 10 is kept inserted inside the internal cavity 3 of the hollow stem 2, ensuring structural continuity.

[0151] The perforating tool 500 is then uncoupled from the hollow stem 2.

[0152] The threaded head portion 22a of the second fastening element 30 is fixed inside the distal end of the bone.

[0153] The external thread 21a of the first fastening element 20 is fixed inside the internal thread 41 of the first rod end 4 and then the threaded head portion 22a of the first fastening element 20 is fixed inside the proximal end 802 of the bone.

[0154] As discussed above, the pronounced conical form of the threaded head portion 22a of the fastening elements 20, 30 allows them to be inserted inside the bone end without affecting the growth cartilage 805 (see FIG. 28).

[0155] Moreover, the operations for inserting the rod 10, the fixing of the fastening elements 20, 30 inside the bone and the tightening of the first fastening element 20 together with the first stem end 4 may be carried with the assembly consisting of manoeuvring tool and movement tool 600 described above.

[0156] An alternative surgical technique may envisage the use of a perforating tool 500′ which has a smaller length than that of the long bone in which it is inserted, such as that shown in FIGS. 15 and 16. The production of a shorter tool results in savings in terms of production costs.

[0157] In this case the hollow stem 2 may be coupled to the coupling end 501 of the perforating tool 500 before the perforating tool 500 is inserted into the bone (see FIG. 17).

[0158] In particular, the perforating tool 500 may be supplied already assembled on the hollow stem 2, thus allowing the surgeon to dispense with this step and therefore reducing the number of operating steps.

[0159] In this case, during the advancing movement of the perforating tool 500′, the hollow stem 2 of the telescopic nail 1 compensates for the smaller length of the tool, itself acting as an extension of the tool so as to guide the advancing movement.

[0160] From the above description it clearly emerges how the telescopic nail and the perforating tool according to the present invention achieve the predefined objects and result in numerous advantages compared to the devices of the prior art.

[0161] Obviously, the person skilled in the art may make numerous modifications and variations to the invention described above in order to meet any specific requirements which may arise, all of these being moreover contained within the scope of protection of the invention as defined by the following claims.