WO2017191530A1

WO2017191530A1 - Hyperextension orthopaedic brace

Info

Publication number: WO2017191530A1
Application number: PCT/IB2017/052393
Authority: WO
Inventors: Daniele ALBERIO; Paolo Caporello; Mauro Ravese; Francesco Turconi
Original assignee: Orthoservice Ag
Priority date: 2016-05-02
Filing date: 2017-04-26
Publication date: 2017-11-09
Also published as: ITUA20163068A1

Abstract

A hyperextension orthopaedic brace (10) comprising a frame structure composed of a pair of upper sternal bars (12) with substantially horizontal development and mutually adjustable, two pairs of lateral uprights (26, 28) with substantially vertical development, each comprising an upper lateral upright (26) and a lower lateral upright (28) mutually adjustable, as well as a substantially horizontal pelvic band (34) for connecting the pairs of lateral uprights (26, 28), as well as a rear belt (36) for the application to the trunk, constrainable at the opposite ends thereof to the pairs of lateral uprights (26, 28), has pairs of lateral uprights (26, 28) constrained to the pelvic band (34), at the ends thereof, by means of a spherical joint (40) comprising a monolithic body (42), made in a single piece of thermoplastic material and stably constrained at an end of the lower lateral upright (28), wherein the monolithic body (42) comprises a spiral spring (46), made in a single piece with the monolithic body by means of a lamina connected at a peripheral end thereof in a single point of the inner wall of a central opening (45) and wound in a spiral, in clockwise or counterclockwise direction, towards the centre of the same, identifying, at the opposite end thereof, a central button (47) provided with anti- rotational stable engagement means with the pelvic band (34).

Description

HYPEREXTENSION ORTHOPAEDIC BRACE

The present invention relates to a hyperextension orthopaedic brace with spherical joint, which can be used for the treatment of moderate and serious back- lumbar injury.

Numerous pathologies or trauma outcomes require stabilisation of the spine and antigravity action on the rachis to lighten it from the load of the upper trunk which normally, by gravity, is released precisely along the rachis.

The diseases concerned are trauma outcomes, such as vertebral fractures, tumors, which can lead to the occurrence of vertebral metastases resulting in increased porosity of the bone structure affected, or osteoporosis due to ageing, which can lead to vertebral collapse associated with compression of the nerve endings .

Currently, the needs of immobilization and lightening of the load on the rachis are solved by means of a so-called hyperextension brace which the patient should always wear when in the upright position. In this circumstance, in fact, the load of the upper trunk rests entirely on the spine.

The hyperextension orthopaedic brace consists of an aluminium light-alloy frame structure that, when worn on the trunk, offers two thrust points in the front area, definable in the chest area (sternum) and on the pelvis, and a thrust point in the back area (usually at the back-lumbar passage), created with a stiff belt constrained to the aluminium structure.

In order to improve the comfort of patients, the chest and lumbar support points consist of cushioned plates that guarantee the advantageous distribution of pressure over a larger surface area.

Hyperextension orthopaedic braces are normally available in various sizes, but they must still be perfectly adjusted and adapted to the morphology of each individual patient. Adjustments may relate to the width of the thoracic spine at the sternum level and the height of the trunk and the angle inclination of the pelvic band. In order to wear the hyperextension brace, in addition to making adjustments of the frame structure by means of screws, the lumbar plate must be positioned by stretching and adjusting the rear belt through a buckle system.

Also the pelvic band, which in some cases must vary its relative position with respect to the frame structure, such as to allow the patient to sit with the brace worn, is adjusted by leaving it free to pivot within a predetermined adjustable angular range or by locking it in a fixed position.

The joint between the lateral uprights of the frame structure and the pelvic band can be implemented by applying a torsion metal spring constrained at one end to the pelvic band and at the other end to the end part of the lateral metal upright. The rotation around a central pivot of the joint can be driven by at least one angular groove in which a pin slides. An additional rotation locking device is further provided, designed for the simultaneous engagement with the lateral upright and the pelvic band in different mutual angular positions.

Known joints provide for the presence of a high number of mechanical components to be assembled together to implement the hyperextension orthopaedic brace .

Moreover, the arrangement of angular guiding grooves in which a pin engages with axis orthogonal to the plane of rotation of the joint may result in the risk of rotation lock in the presence of deformations of the lateral uprights that lead to an inclination of the same with respect to the rotation plane of the j oint .

The aim of the present invention is to provide a hyperextension orthopaedic brace with spherical joint that is adjustable with accuracy and safety, reconciling the needs of both the patient and the orthotist .

Another aim of the invention is to provide a hyperextension orthopaedic brace with spherical bearing that is efficient irrespective of the conditions of use and in the course of use over time.

A further aim of the present invention is to provide a hyperextension orthopaedic brace with spherical joint which is particularly simple, functional and cost-effective.

These aims according to the present invention are achieved by providing a hyperextension orthopaedic brace with spherical joint as described in claim 1.

Further characteristics of the invention are highlighted in the dependent claims, which are an integral part of the present description.

The characteristics and the advantages of a hyperextension orthopaedic brace with spherical joint according to the present invention will become apparent from the following exemplary and non-limiting description, made with reference to the accompanying schematic drawings, in which:

figure 1 is a perspective view of a hyperextension orthopaedic brace with spherical joint according to the invention;

figure 2 is an exploded view of the left spherical joint of the hyperextension orthopaedic brace of figure i;

figures 3 and 4 show a detail of the left spherical joint of the hyperextension orthopaedic brace of figure 2, shown from the front side and the back side, respectively;

figure 5 shows a detail of the right spherical joint of the hyperextension orthopaedic brace of figure 1;

figures 6-8 show the right spherical joint of the brace of figure 1 in a free rotation position, locked in an intermediate stroke position and locked in end- stroke position, respectively.

With reference to the figures, a hyperextension orthopaedic brace with spherical joint is shown, according to the present invention, indicated as a whole with reference numeral 10. Brace 10 consists of an aluminium light-alloy frame structure provided with relative movements for adjusting the chest width, the height of the trunk and pelvis positioning. To the frame structure are applied, by using appropriate fastening elements, accessories forming padded surfaces at the points of contact with the patient's trunk, and a belt system to tighten the brace when worn.

The frame structure consists of bars with substantially horizontal development, placed at the sternum and pelvis, spaced by substantially vertical lateral uprights. In detail, the frame structure comprises, at the top and in the front position with reference to the user's body, a pair of curved sternal bars 12, so as to accommodate the shape of the chest. The end portions of the sternal bars 12 comprise appropriate means, not shown for simplicity because of known type in the prior art, for the adjustable inclination coupling with the pairs of upper 26 and lower 28 lateral uprights.

The overlapping portions of the sternal bars 12 are provided with a groove 22, or holes, in which constraint elements 24 of known type in the prior art are engaged, that will not be further described herein in detail .

The two upper lateral uprights 26, right and left, with variable angular adjustment, are applied to the sternal bars 12.

Each upper lateral upright 26 is also coupled, in such a way as to allow height adjustment, with the respective lower lateral upright 28, so as to form the entire lateral upright of brace 10. Each pair of upper 26 and lower 28 lateral uprights is kept in contact by means of constraint elements 24, which engage in dedicated holes or grooves made in the upper 26 and lower 28 lateral uprights. The constraint elements 24 can be locked in position, once the correct height adjustment of the entire lateral upright has been obtained .

The lower lateral uprights 28 end with a bent lower portion 30, according to a double curve, which follows the enlargement of the user's pelvis and ends with one end constrained to a spherical joint 40 for the adjustable junction to a pelvic band 34, which forms the lower horizontal joining bar between the lateral uprights 28.

The tensioning system comprises a rear belt 36 on which a lumbar plate 38 is fitted. The lumbar plate 37, suitably reinforced and padded, forms the rear thrust point of brace 10. The rear belt 36 can be constrained, at the opposite ends thereof, to the pairs of lateral uprights 26, 28 and comprises means for adjusting the length of the rear belt 36 itself and for tensioning the brace 10.

A plate 37 of support to the sternum is applied to the sternal bars 12, preferably of aluminum, padded and suitably shaped with anatomical shape, which is allowed an oscillatory movement for adapting to the inclination of the sternum wall.

Padded lateral plates 39 are instead applied to the pairs of lateral uprights 26, 28, which have also an anatomical shape to better adapt to the hips and protect them from contact with the lateral uprights themselves. Both the sternal plate 38 and the lateral plates 39 are provided with suitable fastening means to the respective components of the aluminium structure.

The pelvic band 34 consists of a metal core 34a covered with a padding 34b and arched according to an anatomical shape to adapt to the pelvis of the wearer of brace 10.

The spherical joint 40 is stably applied, for example jointed, on the bent end portion 30 of the lower lateral upright 28.

The spherical joint 40, of which a left embodiment is shown in figures 2-4, i.e. located on the left side of the patient wearing brace 10, comprises a monolithic body 42, made in a single piece of thermoplastic material, such as for example polyoxymethylene (POM), polyamide (PA) or polyether ether ketone (PEEK) . Figures 5-8 instead show a right spherical joint 40.

The monolithic body 42 is provided with a slit 43 for inserting the end of the lower lateral upright 28, as well as relative constraint means 44 with the same.

The monolithic body 42 comprises a central circular opening 45 accommodating a spiral spring 46, made in one single piece with the monolithic body. The coil of spring 46 starts from the inner wall of opening

45 and wraps spiral-wise in clockwise or counterclockwise direction towards the centre of opening 45, where its ends identifies a central button 47 provided with anti-rotational stable engagement means with the pelvic band 34.

The central button 47 is perforated to insert, in the example shown, a threaded element 48, which is the centre of rotation of the spherical joint 40 in the plane parallel to the pelvic band 34 and at the end of the lower lateral upright 28. The threaded element 48 is adapted to engage in a threaded hole 49 of the pelvic band 34 to keep the central button 47 of spring

46 integrally tightened against the pelvic band 34.

Further anti-rotational means may be associated with the monolithic body 42 on the side facing the pelvic band 34 to ensure the angularly stable positioning of the central end 47 of spring 46 with respect to the pelvic band 34.

In the example shown by way of example, a plate 50 is positioned on the rear side of the monolithic body 42 within the central opening 45 in engagement with the central button 47 of spring 46 through an anti- rotational shape coupling 51, for example hexagonal. The side of plate 50 facing towards the pelvic band has a pair of pins 52 adapted to engage in a corresponding pair of recesses 53 formed in the pelvic band 34. Equally, the placement of pins and recesses could be overturned, as equivalent anti-rotational means may be adopted. According to an embodiment not shown, plate 50 may not be provided and the anti-rotational shape coupling may occur directly between the monolithic body 42 and the pelvic band.

As described above, the spiral spring 46 works as a torsion spring, constrained to the pelvic band 34 at a central end thereof and to the bent end portion 30 of the lower lateral upright 28 at a peripheral end. Spring 46 loads with the movement of approach of the pelvic band 34 to the lower lateral uprights 28, i.e. the movement that reduces the angle identified between the same, to then return the pelvic band 34 to the starting position at the end of the thrust upwards.

The spiral spring 46 consists of a lamina that at a peripheral end has a single constraint point with the wall of opening 45 of the monolithic body 42 at the point where it detaches from it tangentially to wrap in a spiral. This configuration allows a spherical rotation between the lower lateral upright 28 and the pelvic band 34 of adaptation in case of non-perfect parallelism between the two planes. Advantageously, the pelvic band 34 of the brace according to the present invention is able to rotate with respect to the pairs of lateral uprights, irrespective of the inclination of the same.

Preferably, the angular excursion of the spherical rotation is within the angular range of +/-5⁰ through a first end-stroke consisting of the plate 50 and a second end-stroke consisting of a perforated cover 58, applied on the front side of the monolithic body 42 within the central opening 45 also held in place by the threaded element 48, against which spring 46 abuts. In the preferred embodiment shown, cover 58 is provided with an anti-rotational coupling 60 with the central button 47 of spring 46, for example obtained by a flattened surface, and therefore it rotates integrally with the same and with the pelvic band 34.

Due to the presence of joint 40, the pelvic band

34 has the possibility of pivoting with respect to the pairs of lateral uprights 26, 28, to be able to adapt to the movements of the user of brace 10. For example, when the user sits down, the pelvic band 34 can rotate upwards to not press against the legs and thus prevent the translation of the entire brace 10.

This relative pivoting rotation movement is driven and contained within an angular excursion of angle β, for example of 35°, by a pair of grooved seats 54 with curved profile made on the rear side of the monolithic body 42, on opposite sides with respect to the opening 45, identifying guiding and locking means of the rotational movement, within which corresponding means of the pelvic band 34 engage, such as for example a pair of bushings 55, preferably threaded.

In order to lock the oscillation of the pelvic band 34 and arrange it according to predefined angles with respect to the pairs of lateral uprights 26 and 28, at least one through hole 56 is provided, one for each constraint position, made in the grooved seats 54 for inserting a locking pin 57 of the rotation in engagement in the corresponding threaded bushing 55.

In the example shown, the pelvic band 34 can be left free to pivot with angular excursion β, predetermined by the size of the grooved seats (figure 5), or it may be constrained by the user by inserting the threaded pin 57 in the end-stroke position with lateral uprights and pelvic band substantially orthogonal (figure 7), as well as in an intermediate stroke position (figure 8) . In the example shown, the intermediate locking position corresponds to an angular excursion a, equal to half of the pivoting stroke β.

The through holes 56 for locking the pivoting position can be distributed in each of the two grooves 54 without distinction consistent with the needs of space .

Cover 58, in its embodiment integral in rotation with the central element 47 of spring 46, can advantageously be provided with markings 59 identifying the angular positions corresponding to the possible predefined locking positions.

The operations for the application and adjustment of the hyperextension brace 10 do not differ from what is known in the prior art and are not described.

It has thus been seen that the hyperextension orthopaedic brace with spherical joint according to the present invention achieves the aims described above.

In particular, the provision of a spiral spring of thermoplastic material made in one single piece with the central monolithic body advantageously allows obtaining at the same time both the pivoting and the spherical rotation with an elastic return effect and applying an elastic preload for both joint movements.

Moreover, the spring of thermoplastic material has the advantage of not losing elasticity over time.

The angular excursions of both joint movements are advantageously delimited by mechanical end-stroke elements .

The hyperextension orthopaedic brace with spherical joint according to the present invention further advantageously comprises a small number of components both for implementing the joint between lateral uprights and pelvic band and for guiding and locking the joint. The hyperextension orthopaedic brace with spherical joint of the present invention thus conceived can be subjected to numerous modifications and variations, all falling within the same inventive concept; moreover, all details may be replaced with technically equivalent elements. In the practice, the materials used as well as the shapes and dimensions, may be any, according to technical requirements.

The scope of protection of the present invention is therefore defined by the appended claims.

Claims

1. Hyperextension orthopaedic brace (10) comprising a frame structure composed of a pair of upper sternal bars (12) with substantially horizontal development and mutually adjustable, two pairs of lateral uprights (26, 28) with substantially vertical development, each comprising an upper lateral upright (26) and a lower lateral upright (28) mutually adjustable, as well as a substantially horizontal pelvic band (34) for connecting said pairs of lateral uprights (26, 28), the brace (10) further comprising a rear belt (36) for the application to the trunk, constrainable at the opposite ends thereof to said pairs of lateral uprights (26, 28), characterised in that said pairs of lateral uprights (26, 28) are constrained to the pelvic band (34), at the ends thereof, by means of a spherical joint (40) comprising a monolithic body (42), made in a single piece of thermoplastic material and stably constrained at an end of said lower lateral upright (28), wherein said monolithic body (42) comprises a spiral spring (46), made in a single piece with the monolithic body by means of a lamina connected to a peripheral end thereof in a single point of the inner wall of a central opening (45) and wound in a spiral, in clockwise or counterclockwise direction, towards the centre of the same, identifying, at the opposite end thereof, a central button (47) provided with anti-rotational stable engagement means for engaging with said pelvic band (34) .

2. Hyperextension orthopaedic brace (10) according to claim 1, characterised in that said central button (47) is perforated to receive a threaded element (48), said pelvic band (34) comprising a corresponding threaded hole (49) for constraining with said threaded element (48) in order to keep the central button (47) of the spring (46) tightened in a stable manner against the pelvic band (34) .

3. Hyperextension orthopaedic brace (10) according to claim 2, characterised in that said spherical joint (40) comprises a plate (50) positioned on the rear side of the monolithic body (42) within said central opening (45) and associated in engagement with said central button (47) of the spring (46) by means of anti- rotational shape-coupling (51), said plate (50) and said pelvic band (34) being provided with anti- rotational complementary means (52, 53) on their facing sides .

4. Hyperextension orthopaedic brace (10) according to claim 3, characterised in that said complementary anti-rotational means (52, 53) placed on facing sides of said plate (50) and of said pelvic band (34) consist of a pair of pins (52) adapted to be engaged in a corresponding pair of recesses (53) .

5. Hyperextension orthopaedic brace (10) according to claim 3, characterised in that said spherical joint (40) comprises a perforated cover (58), applied on the front side of the monolithic body (42) within the central opening (45) and kept in position by the threaded element (48), said plate (50) and said cover (58) identifying abutment surfaces for said spring (46) constituting a first end stroke and a second end stroke for the spherical rotation of the spherical joint (40) .

6. Hyperextension orthopaedic brace (10) according to claim 5, characterised in that said cover (58) is provided with an anti-rotational coupling (60) with said central button (47) of the spring (46) .

7. Hyperextension orthopaedic brace (10) according to any of the preceding claims, characterised in that said spherical joint (40) comprises means for guiding and for blocking the oscillating rotation movement, said means engaging with corresponding means of said pelvic band (34) .

8. Hyperextension orthopaedic brace (10) according to claim 7, characterised in that said guiding and blocking means of the oscillating rotation movement comprise a pair of grooved seats (54) obtained on the rear side of the monolithic body (42) within which corresponding means of the pelvic band (34) are engaged, such as for example a pair of bushings (55) .

9. Hyperextension orthopaedic brace (10) according to claim 8, characterised in that said grooved seats (54) comprise at least one through hole (56) for inserting a pin (57) for blocking the rotation in engagement in the coresponding bushing (55) of the pelvic band (34) .

10. Hyperextension orthopaedic brace (10) according to claim 6, characterised in that said cover (58) has marks (59) identifying the angular positions of the pelvic band (34) corresponding to the predefined possible lock positions.