WO2020148715A1

WO2020148715A1 - Orthopaedic brace

Info

Publication number: WO2020148715A1
Application number: PCT/IB2020/050370
Authority: WO
Inventors: Alberto ABBRUZZESE; Alessandro CICCARELLI; Elio Matteo CURCIO; Vincenzo GENOVESE; Matteo GENOVESE; Anthony Gallo; Giuseppe LUCI
Original assignee: Me.Di.Cal S.R.L.
Priority date: 2019-01-18
Filing date: 2020-01-17
Publication date: 2020-07-23
Also published as: IT201900000815A1

Abstract

Orthopaedic brace (10) comprising: - at least two annular members (11, 12), each designed to surround an anatomical part of a user; - at least one connecting member (13, 14) which extends between two ends (15, 16) thereof along an operating direction (A); The connecting member (13, 14) and the annular members (11, 12) are configured to be coupled together so as to prevent relative movements of the limb portions surrounded by the annular members (11, 12). The latter have a length which is adjustable so that they can be adapted to the dimensions of the portion to be surrounded and are deformable so that they can adapt ergonomically to anatomical parts of the user.

Description

ORTHOPAEDIC BRACE

TECHNICAL SECTOR

The present invention relates to the sector of medical devices for orthopaedic use, especially intended for the immobilization of parts of the body especially following injuries in particular to the skeletal system.

BACKGROUND ART

Nowadays the treatment of bone fracture injuries involves mainly the use of a plaster brace which is formed directly on the damaged part of the patient.

This solution has numerous drawbacks in view of the preparation and application time and the stability of the structure which may not be removed and applied again, for example if it is required to perform X-ray check-ups during the healing period.

In view of the widespread use and increasingly greater availability of 3D printing technology, nowadays solutions have been tested where the zone to be treated undergoes a 3D scan, an ergonomic brace is designed on the basis of the scanned zone and the brace is made by means of 3D printing using plastic material.

The use of 3D printing technology is, however, not without drawbacks.

It in fact requires a voluminous and costly infrastructure, qualified personnel in order to manage it and constant training of said personnel.

Furthermore the design and manufacture of a brace obtained by means of 3D printing requires long execution times.

SUMMARY

This unresolved problems have given rise to the study carried out by the Applicant which not only proposes an innovative solution, but completely solves the main problems posed by the alternative solutions present on the market today.

The problem underlying the present invention is in fact that of providing an orthopaedic brace which is simpler and faster to apply than a conventional plaster, but which is essentially equally ergonomic and adaptable to the patient's limb to be treated and, at the same time, may be applied to and removed from the patient's body as easily as a brace formed by means of 3D printing.

The task of the present invention is therefore that of proposing an orthopaedic brace which is able to solve the aforementioned problem.

In connection with this task it is an object of the present invention to provide an orthopaedic brace which may be easily re-used for the treatment of injuries. Another object of the present invention is to propose an orthopaedic brace which may be applied to a patient in a simple and rapid manner, without requiring any specific skills.

Yet another object of the present invention is to propose an orthopaedic brace which may be easily made using known reliable technologies and which is structurally simple and easy to use.

A further object of the present invention is to provide an orthopaedic brace which is modular so as to be able to be adapted essentially to any limb of any patient.

This task as well as these and other objects which will appear more clearly below are achieved by an orthopaedic brace according to the attached independent claim. The dependent claims describe possible features of an orthopaedic brace according to the present invention.

Said claims, as filed, are incorporated herein for the purpose of specific reference.

BRIEF DESCRIPTON OF THE DRAWINGS

The attached series of drawings show, by way of a non-limiting example, an embodiment of the orthopaedic brace according to the present invention, where:

- Figure 1 shows a perspective view of an orthopaedic brace according to the invention;

- Figure 2 shows a perspective view of a component of the orthopaedic brace according to Figure 1 , i.e. an annular member, some parts having been omitted so that other parts are more clearly visible;

- Figure 3 shows an enlarged view of the orthopaedic brace according to Figure

1 ;

- Figure 4 shows a further detail, on a larger scale, of the orthopaedic brace according to Figure 1 , where some parts are shown transparent so that other parts may be more clearly seen;

- Figures 5 to 7 show a variant of the orthopaedic brace shown in the preceding figures;

- Figures 8 and 9 show the orthopaedic brace according to the invention in a further embodiment different from that shown in the preceding figures.

DETAILED DESCRIPTION

With particular reference to the attached figures, these show, by way of a non limiting example, an orthopaedic brace according to the invention denoted overall by the reference number 10. The orthopaedic brace 10 comprises:

- at least two annular members 11 , 12, each designed to surround an anatomical part of a user;

- at least one connecting member 13, 14 which extends between two ends 15, 16 thereof along an operating direction A.

The connecting member 13, 14 at its ends 15, 16 and the annular members 11 , 12 are configured to be coupled together so as to prevent relative movements of the limb portions surrounded by the annular members 11 , 12.

Along a direction of annular extension, the annular members 11 , 12 have a length which is adjustable so as to adapt the annular members 11 , 12 to the dimensions of the anatomical part.

For example, in the case of application of the orthopaedic brace 10 for the treatment of an injury to the wrist joint, a first one 11 of the annular members 11 , 12 may be adapted so as to surround the metacarpal zone and a second one 12 of the annular members 11 , 12 may be adapted to surround the middle zone of the forearm.

Thus, once at least one connecting member 13, 14 has been fixed so as to form a bridge between the annular members applied to the patient, the wrist of the patient will be locked in position in a manner substantially similar to the application of a plaster.

Clearly, the annular members 11 , 12 may be deformable so that they can adapt anatomically to the anatomical parts of the user.

In this way, an orthopaedic brace 10 according to the invention may be easily adapted to the anatomical form of the patient, by adjusting the length of the annular elements 11 , 12 and, by choosing one or more connecting members 13, 14 with a length suitable for the specific application, an injured body part may be locked in position in a quick and flexible manner.

The orthopaedic brace 10 according to the invention may therefore be easily removed from the user's body, by disassembling the annular members 11 , 12 and the connecting members 13, 14 so as to allow both any adjustments needed during the period of treatment of the patient and the removal and reuse of the orthopaedic brace 10 at the end of the said treatment.

In the embodiment shown in the attached figures, the orthopaedic brace 10 comprises two annular members 11 and 12 connected by two connecting members 13 and 14 and arranged opposite each other; however, more than two annular members and a plurality of connecting members may be provided, depending on the specific application and the treatment requirements which arise, since the orthopaedic brace 10 has a modular and adjustable structure as will emerge more clearly from the description of the possible features of the invention, provided below.

Each of the annular members 11 , 12 may comprise two rigid blocks 17a, 18a, 17b, 18b which are connected together by deformable joining parts, denoted overall by the reference number 19.

Each of the rigid blocks, 17a, 18a, 17b, 18b and each of the ends 15, 16 of the connecting member 13, 14 are provided with coupling means able to couple together the blocks 17a, 18a, 17b, 18b and the ends 15, 16.

The presence of these rigid blocks 17a, 18a, 17b, 18b together with the deformable joining parts 19 enables complete locking of the anatomical part concerned to be achieved, while however ensuring the adaptability of the structure of the brace 10 to the various biometric dimensions. Each of the blocks 17a, 18a, 17b, 18b may be configured so as to extend between its two terminal parts, generally indicated by the reference numbers 20 and 21 in both the blocks 17a, 18a, 17b, 18b along a direction of extension B. Each of the terminal parts 20, 21 may have an insertion seat, denoted overall by the reference number 22, 23 for the respective terminal parts 20 and 21.

Each of the joining parts 19 may have a coupling element 24 configured to be inserted inside the insertion seat 22, 23 inside which it is slidable so to adjust the relative position of its joining part 19 with respect to the respective block 17a, 18a, 17b, 18b.

The coupling elements 24 and the terminal parts 20, 21 may be fastened together so as to prevent the relative - in particular sliding - movement.

In this way an orthopaedic brace 10, according to these particular features of the present invention, may allow locking in position of an injured body part both in terms of a relative displacement and in terms of a relative rotation. Moreover, the orthopaedic brace 10 thus configured allows the system to be adapted to various biometric dimensions.

For this purpose, the terminal parts 20, 21 may be elastically deformable so as to contract the insertion seat 22, 23 and lock it by means of friction to a coupling element 24 which has been inserted in it.

The blocks 17a, 18a, 17b, 18b may comprise ties - denoted overall by the reference number 25 - which can be coupled to the terminal parts 20, 21 so as to keep the latter in a contracted configuration in which the insertion seat 22, 23 is contracted and coupled by means of interference with the coupling element 24 so as to prevent sliding inside it of the said coupling element 24. Consequently, advantageously, the orthopaedic brace 10, according to these particular features of the present invention, is modular, adjustable and therefore adaptable to the biometric dimensions of different persons. In particular, the adjustment may be performed by forcing the sliding of the coupling element 24 inside the insertion seat 22, 23, owing to the presence of play between the parts, allowing fine and continuous adjustment of the mutual position of the said parts. The stability of the final configuration, i.e. of the contracted configuration, may be ensured by the retaining action exerted by the ties 25.

For the sake of constructional simplicity, the elastic deformability of the terminal parts 20, 21 is obtained by providing them with a cut 26 delimited by two sections 27, 28, where the contracted configuration ensures that the sections 27, 28 move close together, elastically, with respect to a rest configuration in which they are spaced, in order to close the cut 26 so as to contract the insertion seat 22, 23.

Each of the sections 27, 28 may comprise a fastening element 29, 30.

The ties 25 may be configured so as to be coupled to a fastening element 29, 30 of each of the sections 27, 28 so as to retain the sections 27, 28 in the contracted configuration. The locking in the contracted configuration allows resting of the anatomical zone concerned, avoiding stress and micro movements which could impair the effectiveness and, consequently, the benefits which may be obtained by using the brace.

In particular, the ties 25 may comprise or consist of metallic springs, for example made of spring steel which, once fastened to the oppositely arranged fastening elements 29, 30 of the two facing sections 27 and 28, by means of the elastic contracting action, pull the latter towards each other so as to bring them into said contracted configuration. The said coupling means, for coupling the connecting members 13 and 14 to the annular members 11 and 12, may comprise, in particular, female elements 31 which are fixed to the blocks 17a, 18a, 17b, 18b or to the connecting member 13, 14, and male elements 32 which are fixed, respectively, to each of the ends 15, 16 of the connecting member 13, 14 or to the blocks 17a, 18a, 17b, 18b.

The male elements 32 may be coupled by means of snap-engagement inside the female elements 31 so as to fix together a connecting member 13, 14 and an annular member 11 , 12.

Advantageously, the combined coupling of male elements 32 and female elements 31 defines a rigid system which helps further obtain full locking of the anatomical part concerned.

The joining parts 19, in order to be adjustable lengthwise, may comprise link elements 33 and pins 34 for hinging the link elements 33 in series to form a track-like element.

Thus, the length of the joining parts may be adjusted by adding or removing link elements 33.

The link elements 33 will have through-holes in their opposite terminal sections which will be shaped in a complementary manner such that a pin 34 may be inserted at the same time through the holes of a first section of a link element 33 and inside the hole of the second section, complementing said first section, of a further link element 33 adjacent to it.

Therefore, a track-like element, which is modular and with a variable size in the circumferential direction, i.e. in said direction of annular development, is obtained. In addition, the track-like element thus configured has a simple design and may easily applied to the injured body part to be treated.

The connecting member 13, 14 may be telescopic and configured so as to counteract the relative rotation of its ends 15, 16. In particular, the ends 15, 16 of the connecting member 13, 14 may be connected rigidly to the annular members 11 , 12. Coupling of the ends 15, 16 of the connecting member 13, 14 may be performed by means of snap-engagement and/or by means of deformable coupling, for example elastically by means of interference, inside the female elements 31.

Consequently, the connecting member 13, 14 is able to ensure the structural stability of the brace 10 and allow adjustment or adaptation of the relative positioning of the annular members 11 , 12 along the operating direction A.

The connecting member 13, 14 may comprise a male component 35 provided with a protuberance 36 and a female component 37 comprising an engaging seat 38 adapted to receive by means of insertion the protuberance 36 which is slidable in the engaging seat 38 so as to adjust the relative distance of the ends

15, 16 of the connecting member 13, 14.

The protuberance 36 and the engaging seat 38 may be configured so that they can be coupled together with a form fit which counteracts the relative rotation about an insertion direction C of the protuberance 36 in the engaging seat 38. Owing to the presence of the male component 35 and the female component 37 it is possible to obtain directly a form fit, without the need for further coupling components. Therefore, both the manufacture and the assembly of these components is simplified and performed more rapidly.

In detail, the female component 37 may comprise a primary body 39 and a locking element 40 each defining a portion of the engaging seat 38 in such a way that the primary body 39 and the locking element 40 define cooperatively the engaging seat 38.

The locking element 40 can be separated from the primary body 39 in order to facilitate insertion of the protuberance inside the portion of the engaging seat 38 provided in the primary body 39.

The locking element 40 may be configured to be coupled with the primary body 39 and the protuberance 36, following engagement of the latter in the primary body 39, in order to lock the protuberance 36 to the female component 37 so as to prevent a movement with respect to the latter. If the locking element 40 is coupled to the primary body 38, the brace 10 is a rigid body. During use, therefore, if the locking element 40 is coupled to the primary body 39, the brace 10 may prevent a movement of the injured limb part, for example a joint. Differently, if the locking element 40 is not coupled to the primary body 39, the protuberance 36 is free to slide, in a limited but in any case guided manner, inside the engaging seat 38. During use, therefore, if the locking element 40 is not coupled to the primary body 39, the brace 10 may perform a partially locking function. Thus, advantageously, it is possible to use the brace as a "rigid brace" or as a "partially locking brace". In addition, by means of the aforementioned connecting member 13, 14, it is possible to adjust, also during the post application phase, the relative distance between the annular members 1 1 , 12, for example should undesirable effects arise on the injured limb, such as too strong a pressure, pain from excessive contact, etc.).

In order to ensure the stability and at the same time the coupling reversibility of the locking element 40 with the primary body 39, the latter may be provided with a plurality of operating seats 41 which may be engaged by protuberances, not visible in the attached figures, projecting from the locking element 40.

It can therefore be understood how both the annular members 11 , 12 and the connecting members 13, 14 may be easily adjusted along their lengths so as to adapt ergonomically to the anatomical parts of the user of the orthopaedic brace 10.

Moreover, the orthopaedic brace 10 may be easily assembled and disassembled for mounting and removal, respectively.

With particular reference to Figures 5 and 6, these show a possible variant of the orthopaedic brace 10 described above.

This variant differs with respect to that described above in that the blocks 17a, 18a, 17b, 18b may comprise two complementary elements 42, 43, one of which may be provided with a pin 44 and one with an engaging hole 45 adapted to receive the pin 44 so as to join together the complementary elements 42, 43. Preferably, the joining together of the complementary elements 42, 43 is performed by means of snap-engagement of the pin 44 inside the engaging hole 45.

The coupling elements 24 may have at least one side wall 46 shaped so as to create a form fit with an inner wall of the blocks 17a, 18a, 17b, 18b, which is not visible in the attached figures.

In particular, the side wall 46 and the inner wall may have knurled zones, as shown in Figure 6, so as to counteract the relative sliding of the coupling element 24 with respect to the block 17a, 18a, 17b, 18b when the complementary elements 42, 43 are coupled together. These knurled zones may act as locating/counteracting elements, thus favouring the form fit and therefore engagement/locking together of the complementary elements 42, 43. In this connection, the pin 44 and the engaging hole 45 may be configured to define two preferential relative positions for the complementary elements 42, 43:

- a first position in which the complementary elements 42, 43 are splayed so as to allow the sliding of a coupling element 24 inside an insertion seat 22, 23, shown by way example in Figure 7, and

- a second position in which the complementary elements 42, 43 are fully coupled together to prevent the sliding of a coupling element 24 inside an insertion seat 22, 23.

Therefore, in the first position, the complementary elements 42, 43 may be configured to allow the adjustment of the position of the coupling element 24 so as to adapt the width of each annular member 11 , 12 to the biometric dimensions of the zone concerned. In the second position, the complementary elements 42, 43 may be configured to keep or lock in position the coupling element 24,

The pin 44 and the engaging hole 45 may be in a central position of the complementary elements 42 and 43 so as not to interfere with the coupling elements 24 when they are inserted or during insertion/extraction into/from the respective insertion seat 22, 23.

Figures 8 and 9 show an additional embodiment of the orthopaedic brace according to the invention, denoted overall by the reference number 100.

In these figures and in the following description, elements similar to those described here and with characteristics different from those of the orthopaedic brace 100 are indicated with the same reference numbers in so far as described or visible below in the said figures. The annular members 11 and 12 may comprise two complementary half-shells 101 , 102 which may have a substantially U-shaped profile and which may be joined together at their end edges 48a, 48b, 49a, 49b.

The end edges 48a, 48b, 49a, 49b may be configured so as to be joined together by means of one or more threaded elements 50. Preferably, each pair of end edges 48a, 48b, 49a, 49b may define a seat suitable for coupling with a threaded element 50. Even more preferably, each seat may comprise an internally threaded bush suitable for being coupled with the threaded element 50. The threaded element 50, such as, for example, a threaded screw, may be suitable for being inserted, at least partially, inside said bush. In particular, the threaded element 50 may be configured to be screwed into or unscrewed from said bush. The threaded element 50 may therefore be able to perform a rotary translation movement with respect to said bush. The coupling together of the bush and the threaded element 50 may result in clamping of the annular member 11 , 12 in an axial direction with respect to the threaded element 50. The adjustment of the relative position of the bush and the threaded element 50 may be permitted until an abutment or end-of-travel position of the threaded element 50 inside said seat is reached. The adjustment of the relative position of the bush and the threaded element 50 may allow dimensional adaptation of the annular member 11 , 12.

Moreover, the annular members 11 and 12 may comprise an annular band 51 which may be made of soft material and preferably a polymeric material such as silicone or an elastomeric material, so as to adapt ergonomically to the part of the user to which it is applied. This annular band 51 allows simple and rapid adaptation of the brace 10 to different biometric dimensions to be obtained. Moreover, the annular band 51 may perform a protective function for the skin. The annular band 51 may be surrounded by the two half-shells 101 , 102 when they are joined together.

The connecting members, indicated here by the common reference number 103, may be rod-shaped and able to be fixed to sleeves 52 provided on the half shells 101 , 102, for example by means of threaded members 53, for example screws or grub screws. Alternatively the connection between the connecting members 103 and the sleeves 52 may be of the pin engagement or clip engagement type for interference with the connecting member 103.

The connecting members 103 may be telescopic and may be configured to form a reversible type connection with the annular members 11 and 12. In this way, it is possible to adjust, also during the post-application phase, the relative distance between the annular members 11 , 12, for example should undesirable effects arise on the injured limb (such as too strong a pressure, pain from excessive contact, etc.).

The annular members 11 and 12 may also be provided with:

- a magnetotherapy device, i.e. a system of batteries which generates a magnetic field which increases and accelerates the bone healing time and therefore the recovery time of the fracture treatment;

- a movement sensor system, with accelerometers and gyroscopes, which allows adjustment of the limb movements, for example connected to an loT (Internet of Things) system, and a software application in particular for smartphones, which will allow the attending physician and patient to communicate during the recovery period, acting as a "trainer" and "psychological stimulator", by means of encouragement of the avatar present in the application and the creation of end goals with rehabilitation exercises.

In this connection, finally, the system may be developed by providing the avatar with artificial intelligence (Al).

It is clear that the structure described is suitable for ensuring a high degree of modularity which will allow a wide range of applications for the orthopaedic brace according to the present invention.

Overall, the solution proposed may be easily installed and also offers many advantages including:

- the low manufacturing cost; this in fact allows outsourcing of production using plastic injection-moulding techniques;

- ease of installation;

- the modularity, which allows adaptability to the anatomical parameters of any person;

- the fact of avoiding having to replace the plaster casting nurse, who would be responsible for application of an orthopaedic brace according to the invention, thus reducing the amount of time needed and simplifying the installation processes;

- the ease of re-use, requiring the simple application of a sterilization process;

- the flexibility of use, in view of the modularity and the possibility of adjusting the tension, this helping ensure the transition from a rigid technique, associated with the application of plaster, to the function of a proper orthopaedic brace;

- simple and fast production which does not require long moulding and delivery times since the orthopaedic brace according to the present invention may be mass-produced, allowing therefore optimization of the warehouse and stock management. It can therefore be understood how the present invention is able to fulfil the task and achieve the predefined objects.

Claims

1. Orthopaedic brace (10) comprising:

- at least two annular members (11 , 12) each adapted to surround an anatomical part of a user;

- at least one connecting member (13, 14) which extends between two ends (15, 16) thereof along an operating direction (A);

said connecting member (13, 14), at said ends (15, 16), and said annular members (11 , 12) being configured to be coupled together so as to prevent relative movements of the limb portions surrounded by said annular members (11 , 12);

said annular members (11 , 12) having a length, which extends along a direction of annular development, which is adjustable so as to adapt said annular members (11 , 12) to the dimensions of the anatomical part;

said annular members (11 , 12) being deformable so as to adapt anatomically to anatomical parts of the user.

2. Orthopaedic brace (10) according to claim 1 , wherein each of said annular members (11 , 12) comprises two rigid blocks (17a, 18a, 17b, 18b) which are connected together by deformable joining parts (19); each of said rigid blocks (17a, 18a, 17b, 18b) and each of the ends (15, 16) of said connecting member (13, 14) being provided with coupling means able to couple together said rigid blocks (17a, 18a, 17b, 18b) and said ends (15, 16).

3. Orthopaedic brace (10) according to claim 2, wherein each of said blocks (17a, 18a, 17b, 18b) extends between two terminal parts (20, 21 ) thereof along an extension direction (B); each of said terminal parts (20, 21 ) having an insertion seat (22, 23); each of said joining parts (19) having a coupling element (24) configured to be inserted in said insertion seat (22, 23) in which it slides to adjust the relative position of its joining part (19) with respect to said block (17a, 18a, 17b, 18b); said coupling elements (24) and said terminal parts (20, 21 ) can be fastened together so as to prevent relative movement.

4. Orthopaedic brace (10) according to claim 3, wherein said terminal parts (20, 21 ) are elastically deformable in order to contract said insertion seat (22, 23) so as to lock it by means of friction to a coupling element (24) of said joining part (19) inserted in it; said blocks (17a, 18a, 17b, 18b) comprising ties (25) which can be coupled to said terminal parts (20, 21 ) to keep the latter in a contracted configuration in which said insertion seat (22, 23) is contracted to prevent sliding inside it of a coupling element (24).

5. Orthopaedic brace (10) according to claim 4, wherein said terminal parts (20, 21 ) have a cut (26) delimited by two sections (27, 28), said contracted configuration ensuring that said sections (27, 28) move close together elastically, with respect to a rest configuration, in order to close said cut (26) so as to contract said insertion seat (22, 23); each of said sections (27, 28) comprising a fastening element (29, 30), said ties (25) being configured to be coupled to a fastening element (29, 30) of each of said sections (27, 28) so as to retain said sections (27, 28) in said contracted configuration.

6. Orthopaedic brace (10) according to one of claims 2-5, wherein said coupling means comprise female elements (31 ) fixed to said blocks (17a, 18a, 17b, 18b) or to said connecting member (13, 14) and male elements (32) fixed, respectively, to each of the ends (15, 16) or to said blocks (17a, 18a, 17b, 18b); said male elements (32) being able to be coupled by means of snap- engagement into said female elements (31 ) for the relative fixing of said connecting member (13, 14) to said annular members (11 , 12).

7. Orthopaedic brace (10) according to one of claims 2-6, wherein said joining parts (19) comprise link elements (33) and pins (34) for hinging said link elements (33) in series to form a track-like element.

8. Orthopaedic brace (10) according to one of the preceding claims, wherein said connecting member (13, 14) is telescopic and configured so as to counteract the relative rotation of the ends (15, 16) of said connecting member (13, 14) .

9. Orthopaedic brace (10) according to claim 8, wherein said connecting member (13, 14) comprises a male component (35) provided with a protuberance (36) and a female component (37) comprising an engaging seat (38) adapted to receive by means of insertion said protuberance (36) which is slidable in said engaging seat (38) so as to adjust the relative distance of the ends (15, 16) of said connecting member (13, 14); said protuberance (36) and said engaging seat (38) being configured so that they can be coupled together with a form fit that counteracts the relative rotation about an insertion direction (C) of said protuberance (36) in said engaging seat (38).

10. Orthopaedic brace (10) according to claim 9, wherein said female component (37) comprises a primary body (39) and a locking element (40) each defining a portion of said engaging seat (38) in such a way that said primary body (39) and said locking element (40) cooperatively define said engaging seat (38); said locking element (40) being separable from said primary body (39) to allow the insertion of said protuberance (36) in the portion of said engaging seat (38) provided in said primary body (39); said locking element (40) being configured to be coupled to said primary body (39) and to said protuberance (36), following the coupling of the latter with said primary body (39), in order to lock said protuberance (36) to said female component (37) so as to prevent movement with respect to the latter.

11. Orthopaedic brace (10) according to claim 2 and one of the preceding claims, wherein said blocks (17a, 18a, 17b, 18b) comprise two complementary elements (42, 43), one of which is equipped with a pin (44) and one with an engaging hole (45) adapted to receive said pin (44) so as to join together the complementary elements (42, 43).

12. Orthopaedic brace (10) according to claim 11 , wherein said coupling elements (24) have at least one side wall (46) shaped so as to create a form fit with an inner wall of said blocks (17a, 18a, 17b 18b) so as to counteract the relative sliding of said coupling element (24) with respect to said block (17a, 18a, 17b, 18b) when said complementary elements (42, 43) are coupled together.

13. Orthopaedic brace (10) according to claim 12, wherein said pin (44) and said engaging hole (45) can be configured to define two preferential relative positions for said complementary elements (42, 43):

- a first position in which said complementary elements (42, 43) are splayed to allow the sliding of a coupling element (24) in an insertion seat (22,

23), and

- a second position in which said complementary elements (42, 43) are fully coupled together to prevent the sliding of said coupling element (24) in one of said insertion seats (22, 23).

14. Orthopaedic brace (10) according to one of claims 1 -3, wherein said annular members (11 , 12) comprise two complementary half-shells (101 , 102) which may have a substantially U-shaped profile and which are adapted to be joined together at their end edges (48a, 48b, 49a, 49b) which are configured so that they can be joined together by one or more threaded elements (50).

15. Orthopaedic brace (10) according to claim 14, wherein said annular elements (11 , 12) comprise an annular band (51 ) which may be made of soft material and preferably of a polymeric material or elastomeric material, so as to adapt ergonomically to the part of the user to which it is applied.

16. Orthopaedic brace (10) according to claim 14-15, wherein said connecting members (103) are rod-shaped and can be fixed to sleeves (52), provided on said half-shells (101 , 102), for example by means of threaded members (53) .