ORTHOPAEDIC BRACE AND METHOD FOR CUSTOMISING AN ORTHOPAEDIC BRACE

Abstract

An orthopaedic brace includes two rigid valves hinge-coupled to one another and each having a respective pelvic section and a respective supporting shell. The pelvic sections are rigidly coupled to the supporting shells of the respective valves and are made of a thermoformable polymeric material having a softening point between 45° C. and 80° C.

Claims

1. An orthopaedic brace comprising two rigid valves hinge-coupled to one another and each having a respective pelvic section and a respective supporting shell, wherein the pelvic sections are rigidly coupled to the supporting shells of the respective valves, characterised in that the pelvic sections are at least in part made of a thermoformable polymeric first material having a softening point between 45° C. and 80° C.

2. The orthopaedic brace according to claim 1, wherein the first material has Shore A hardness greater than 80 and Shore D hardness greater than 30 at temperatures lower than the softening point.

3. The orthopaedic brace according to claim 1, wherein the first material contains ethylene-vinyl acetate copolymer.

4. The orthopaedic brace according to claim 1, wherein the supporting shells are made of a second material having a stiffness greater than the stiffness of the first material.

5. The orthopaedic brace according to claim 4, the second material is selected so that the supporting shells have stiffness equal to or greater than a stiffness of a body having equal shape and made from a plate of high-density polyethylene (HDPE) with thickness of 4 mm.

6. The orthopaedic brace according to claim 4, wherein the second material has elastic modulus equal to or greater than 800 MPa and/or Shore D hardness equal to or greater than 62.

7. The orthopaedic brace according to claim 4, wherein the second material is a polymeric material having a softening point greater than the softening point of the first material forming the pelvic sections.

8. The orthopaedic brace according to claim 1, wherein the pelvic sections comprise respective iliac supports, shaped for contact with iliac crests of a patient, and trochanteric regions shaped for contact with trochanters of the patient.

9. The orthopaedic brace according to claim 8, wherein the pelvic sections are connected to the respective supporting shells along junction arcs contouring the iliac supports.

10. The orthopaedic brace according to claim 9, wherein the supporting shells comprise respective sacrococcygeal appendixes, that extend downward and rearward along the junction arcs with respect to the iliac supports and respective iliopubic appendixes, that extend downward and frontward along the junction arcs with respect to the iliac supports.

11. The orthopaedic brace according to claim 8, wherein at least the iliac supports and the trochanteric regions are made of the first material.

12. The orthopaedic brace according to claim 1, wherein the supporting shells of the valves are shaped so as to wrap rearward, on one side and frontward a respective half-torso.

13. The orthopaedic brace according to claim 1, wherein each supporting shell comprises a plurality of respective portions, provided as separate parts and rigidly joined to one another to form the respective supporting shell.

14. The orthopaedic brace according to claim 11, wherein each supporting shell (6; 106; 206) comprises adjusting members configured to adjust relative positions of the respective portions.

15. The orthopaedic brace according to claim 1, comprising a rigid spine bar extending in a median sagittal plane between the valves and wherein the valves are hinged to the spine bar in respective dorsal regions.

16. A method for customizing an orthopaedic brace comprising two rigid valves hinge-coupled to one another and each having a respective pelvic section and a respective supporting shell, wherein the pelvic sections are rigidly coupled to the supporting shells of the respective valves and are at least in part made of a thermoformable polymeric material having a softening point between 45° C. and 80° C., the method comprising: applying the orthopaedic brace to a patient; heating the pelvic sections to above the softening point of the thermoformable polymeric material; and forming the pelvic sections onto the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Further characteristics and advantages of this invention will become clear from the following description of the non-limiting embodiments thereof, with reference to the accompanying drawings, in which:

[0041] FIG. 1 is a rear perspective view of an orthopaedic brace in accordance with one embodiment of this invention;

[0042] FIG. 2 is a rear orthogonal view of the orthopaedic brace in FIG. 1;

[0043] FIG. 3 is a front perspective view of the orthopaedic brace in FIG. 1;

[0044] FIG. 4 is a front orthogonal view of an orthopaedic brace in accordance with a different embodiment of this invention;

[0045] FIG. 5 is a front orthogonal view of an orthopaedic brace in accordance with another embodiment of this invention;

[0046] FIG. 6 is a front orthogonal view of an orthopaedic brace in accordance with another embodiment of this invention.

BEST MODE FOR CARRYING OUT THE INVENTION

[0047] With reference to FIGS. 1-3, an orthopaedic brace in accordance with an embodiment of this invention is indicated with the reference number 1 and comprises two rigid valves 2 hinge-coupled by means of a spine bar 3, with a hinge axis parallel to a median sagittal plane PS. The term “valve” is derived from the field of zoology, where it indicates each of the two parts forming the shell of some molluscs, and is commonly used in the sector to indicate each of the parts that, in a brace, wrap around and support the patient's torso. In the case of this invention, each valve 2 corresponds to a respective supporting half or main part of the brace 1. It should be understood that the two supporting halves or main parts are not necessarily identical and, on the contrary, may have some structural differences to correct asymmetries typically related to spinal column diseases.

[0048] The hinged coupling enables, on the one hand, the opening of the two valves 2 so that the patient can put on and take off the brace 1, and, on the other hand, the maintenance of the stiffness between the two valves 2 without mutual displacements once the brace 1 is closed. More precisely, in the example of FIGS. 1-3, the spine bar 3 extends on the median sagittal plane PS and is arranged between the valves 2, which are hinged thereto in the respective dorsal regions. The valves 2 are, therefore, opposite each other in relation to the median sagittal plane PS. The hinge coupling, as well as using properly so-called hinges, with pins rotating in seats, may be achieved using belt and buckle systems fixed to one of the valves 2 and to the spine bar 3. In addition, the hinge coupling, in one embodiment, may be made directly between the valves 2, without the spine bar 3. The orthopaedic brace 1 is also equipped with closure members 4, which enable the valves 2 to be tightened at the front in an adjustable way once the patient has put on the orthopaedic brace 1. In one embodiment, the closure members 4 may comprise belts and buckles.

[0049] Each valve 2 has a respective pelvic section 5 and a respective supporting shell 6, rigidly coupled to each other. According to the treatment indications, the valves 2 may or may not be symmetrical.

[0050] The pelvic sections 5 are caps each surrounding a respective half pelvis of the patient when the orthopaedic brace 1 is put on. The pelvic sections 5 together form a pelvis of the orthopaedic brace 1 and comprise respective iliac supports 8 and trochanteric regions 9. The iliac supports 8 are shaped for contact with a patient's iliac crests, so that the forces exerted by the supporting shells 6 of the orthopaedic brace 1 on the patient's torso along its vertical axis are discharged onto the pelvis.

[0051] The pelvic sections 5 are connected to the respective supporting shells 6 along the junction arcs 10 surrounding the iliac supports 8 and extending around the hips. The connection may be made, for example, by welding, gluing, riveting or any technique that is suitable for rigid fastening. The trochanteric regions 9 are shaped for contact with the patient's trochanters, so as to give stability to the brace 1 when worn.

[0052] The pelvic sections 5 are made of a first material, which is a thermoformable polymeric material with a softening point (Vicat Softening Point) ranging between 45° C. and 80° C. In addition, at temperatures below the softening point (and in particular at temperatures of use that normally do not exceed 35-40° C.), the thermoformable polymeric first material with which the pelvic sections 5 are made have a Shore A hardness greater than 80 and a Shore D hardness greater than 30. At operating temperatures, the parameters indicated are suitable for giving the pelvis of the orthopaedic brace 1 enough stiffness to transfer the forces necessary to reduce spinal dysmorphism to the patient's torso.

[0053] In one embodiment, the first material contains ethylene-vinyl acetate copolymer and may have the following composition by weight:

[0054] Ethylene-vinyl acetate copolymer >98%;

[0055] Processing aids <2%;

[0056] Vinyl acetate CAS number 108-05-4<0.3%.

[0057] In the embodiment in FIGS. 1-3, the pelvic sections 5 are made entirely of the thermoformable polymeric first material having the characteristics described above. Alternatively, however, the pelvic sections 5 may comprise parts made of the first material, e.g. the iliac supports 8 and/or the trochanteric regions 9, and parts made of more rigid material, such as the material forming the supporting shells 6.

[0058] The supporting shells 6 of the valves 2 are shaped so that they each wrap a respective half (right or left) of the patient's torso at the back, on one side, and at the front, according to individual needs, and extend from the respective pelvic sections 5 as far as necessary along the patient's torso according to medical instructions. In the embodiment represented in FIGS. 1-3, the supporting shells 6 define axillary supports 11.

[0059] In addition, the supporting shells 6 comprise respective sacrococcygeal appendixes 13 and iliopubic appendixes 15, which cooperate with the pelvic sections 5 to give stability and stiffness to the orthopaedic brace 1 when worn. In particular, the sacrococcygeal appendixes 13 extend downwards and rearward along the junction arcs 10 in relation to the iliac supports 8 to cover the patient's sacral region. The iliopubic appendixes 15 extend downward and frontward along the junction arcs 10 in relation to the iliac supports 8.

[0060] In one embodiment, moreover, each supporting shell 6 comprises a respective front section 6a and a respective back section 6b, made as separate parts and joined together along a coronal plane PC. The relative position of the front section 6a and of the back section 6b of each valve 6 in the direction perpendicular to the coronal plane PC may be adjusted by adjusting members 16. The adjusting members in one embodiment are adjusting screws, but could, alternatively, comprise tensioners, hooks and racks, belt and buckle systems and any other suitable devices.

[0061] In an embodiment not illustrated, however, the supporting shells 6 may each be made of a single piece.

[0062] The supporting shells 6 are made of a second material with greater stiffness than the first material forming the pelvic sections 5. In addition, the second material is selected so that the supporting shells 6 maintain their stiffness basically unchanged even during the thermoforming steps of the pelvic sections 5, as described below. In general, the second material may be advantageously selected so that the supporting shells 6 have a stiffness equal to or greater than the stiffness of a body that has the same shape and is made from a plate of high-density polyethylene (HDPE) that is 4 mm thick. In addition, the second material has an elastic modulus equal to or greater than 800 MPa and/or a Shore D hardness equal to or greater than 62.

[0063] In one embodiment, the second material may be a polymeric material with the features indicated and having a softening point greater than the softening point of the first material forming the pelvic sections 5. For example, the second material has a softening point equal to or greater than 100° C., preferably equal to or greater than 130° C. In one embodiment, in particular, the supporting shells 6 of the valves 2 are made of high-density polyethylene (HDPE). In a different embodiment, the supporting shells of the valves 2 may be made of a composite material comprising carbon fibres embedded in a matrix.

[0064] The orthopaedic brace 1 may be made with a small number of standard moulds and then customised by thermoforming the pelvis, which requires high precision in order to correctly discharge the forces onto the patient's pelvis.

[0065] After the orthopaedic brace 1 has been placed on the patient, the pelvic sections 5 are heated and brought above the softening point of the thermoformable material. Heating may be achieved by using jets of hot air. Alternatively, the pelvic sections may be pre-heated in the oven before the orthopaedic brace 1 is placed on the patient. A temperature of a few degrees above the softening point may be enough for the purpose. In the example described, the pelvic sections 5 can be brought to a temperature ranging between 50° C. and 60° C., which enables the pelvic sections 5 to be shaped directly on the patient and are normally well tolerated. A layer of fabric, e.g. cotton, may be placed between the patient and the orthopaedic brace 1 before heating to reduce the risk of discomfort without compromising the precision of the forming operations.

[0066] The procedure may be carried out when the brace 1 is put on for the first time, until maximum correction is achieved, and may then be repeated whenever it is advisable, for example some time after the start of treatment, when the patient changes his or her posture due to recovery from the dysmorphism.

[0067] According to one embodiment of the invention, illustrated in FIG. 4, the valves 2 comprise respective pelvic sections 5, as already described, and respective supporting shells, here indicated with the number 106. Each supporting shell 106 comprises a respective lumbar section 106a and a respective thoracic section 106b, rigidly coupled to each other. The connection may be permanent, e.g. by bonding or welding, or temporary, e.g. by screw connections 116, which may also serve as adjustment means to adjust the relative position of the lumbar section 106a and the thoracic section 106b along the patient's vertical axis. The pelvic sections 5 are rigidly connected to the lumbar sections 106a of the respective supporting shells 106.

[0068] According to one embodiment, illustrated in FIG. 5, the valves 2 comprise respective pelvic sections 5, as already described, and respective supporting shells 206. Each supporting shell 206 comprises a respective lumbar section and a respective thoracic section, each of which in turn includes a front section and a back section. In practice, each supporting shell 206 comprises one front lumbar section 206a, one back lumbar section 206b, one front thoracic section 206c and one back thoracic section 206c, all connected to form a single rigid body.

[0069] With reference to FIG. 6, in another embodiment of the invention, the valves 2, each comprising a pelvic section 5 and a supporting shell 6, are hinged together at the front by hinges 300 and are closed by closure members 4 arranged at the back in the dorsal region.

[0070] It is clear, finally, that modifications and variations may be made to the orthopaedic brace described herein while remaining within the scope of protection defined by the attached claims.

[0071] In particular, in all embodiments described, any combinations of the materials indicated for the pelvic sections and for the supporting shells may be used. In addition, in any case, the pelvic sections can be entirely made of the thermoformable polymeric first material, or only in certain regions, in particular the iliac supports and/or the trochanteric regions.