WO2023208732A1

WO2023208732A1 - Sternum bar

Info

Publication number: WO2023208732A1
Application number: PCT/EP2023/060325
Authority: WO
Inventors: Leonard Thomas LLOYD
Original assignee: Beagle Orthopaedic Limited
Priority date: 2022-04-29
Filing date: 2023-04-20
Publication date: 2023-11-02
Also published as: GB2618150A; GB202206319D0

Abstract

There is disclosed a sternum bar for use in a thoracic spine brace, the sternum bar comprising: an elongate bar comprising a proximal end and a distal end; a first connection point situated at the distal end of the elongate bar; a connecting element connected to the elongate bar via the first connection point, wherein the first connection point is adjacent a proximal end of the connection element; a second connection point situated at a distal end of the connection element; a brace element connected to the second connection point and configured to provide support to the sternum of a user during use.

Description

Sternum Bar

Field of Invention

The present application is in the field of apparatus for the immobilisation of elements of the human body. This may be directly after an accident, or during the treatment of an injury or condition. In particular, the application relates to a sternum bar for use with immobilising movement of the upper torso region.

Background

Sternum bars are known and used for the immobilisation of the torso of a patient. This may be after an incident, or as a method of treatment. In particular sternum bars may be used as part of a thoracic spine brace.

Sternum bars generally contact the sternum and connect to one or more other immobilisation elements, such as an abdominal immobilisation element, or a neck immobilisation element. This can help keep larger sections of the user still as per their clinical need. As part of a thoracic spine brace sternum bars may connect back and abdominal braces together, whilst also aiding with immobilisation of part of the chest region.

However, patient's come in all shapes and sizes, and must be immobilised at specific position's based on their own personal requirements. At present considerable time and expense is used to personalise each sternum bar for each patient. There is a need for a universal sternum bar to overcome this technical problem.

Statements of Invention

Aspects of the invention are set out in the independent claims. Optional features are set out in the dependent claims.

In accordance with a first aspect there is provided a sternum bar for use in a thoracic spine brace, the sternum bar comprising: an elongate bar comprising a proximal end and a distal end; a first connection point situated at the distal end of the elongate bar; a connecting element connected to the elongate bar via the first connection point, wherein the first connection point is adjacent a proximal end of the connection element; a second connection point situated at a distal end of the connection element; a brace element connected to the second connection point and configured to provide support to the sternum of a user during use. Such a sternum bar is highly advantageous because the use of both a first and a second connection point allows the sternum bar to be significantly more flexible and to be used on a significantly greater proportion of the population without need for it to be personalised to fit.

Optionally, the first connection point operates a joint style connection. This may advantageously allow the connection point to act as a pivot.

Optionally, the first connection point is configured to provide a first pivot point.

Optionally, the pivoting of the connection element relative to the elongate bar is in a single plane. This may advantageously maintain the ability of the sternum bar to restrict movement in the other planes, whilst allowing the sternum bar to be set to an ideal position for each patient.

Optionally, the first connection point is a barrel joint. Whilst other types of joint may be used a barrel joint has been found to be particularly advantageous in allowing movement in one plane whilst constraining movement in other directions. This also lowers the cost of manufacture compared with many alternative joint types.

Optionally, the first and second connection points are parallel with one another.

Optionally, the second connection point operates a joint style connection. This may advantageously allow the connection point to act as a pivot.

Optionally, the second connection point is configured to provide a second pivot point. A second pivot point is highly advantageous as it allows multiple degrees of freedom in the same plane - thus allowing the sternum bar to be fitted to a greater range of users.

Optionally, the brace element relative to the connection element is in a single plane. This may advantageously enable the brace element to brace any forces exerted on the connection points during use.

Optionally, the pivoting of the connection element relative to the elongate bar, and the pivoting of the brace element relative to the connection element are in the same plane. This may advantageously enable the sternum bar to be manipulated in just one plane to fit a user of different proportions, without comprising on the structural integrity of the device.

Optionally, in use the first connection point and the second connection point allow the elongate member and the connection element to form an apex pointing away from the user's body. This may advantageously allow personalisation for different sizes and body shapes without creating user discomfort.

Optionally, the first and second connection points provide two degrees of freedom. This is sufficient freedom to enable personalisation to allow the device to be used on a greater number of users.

Optionally, the two degrees of freedom are provided in the same plane. This increases the strength of the device.

Optionally, the elongate bar comprises an attachment means for attachment to a lumbar supporting means. This may advantageously allow the sternum bar to coordinate with a lumbar supporting means to support a large portion of a user's torso.

Optionally, the attachment means comprises a female element, such as a hole. This may increase ease of use, and may reduce the complexity of manufacture.

Optionally, the attachment means comprises a plurality of holes situated at different positions between the proximal and distal ends of the elongate member, such that the lumbar supporting means may attach to any one of the holes to enable adjustment of the device based upon height of the user.

Optionally, the brace element comprises connection means for attaching to an additional portion of the brace. This may be advantageous, especially if said additional element is a back brace.

Optionally, the connection means comprises two holes situated either side of the sternum when in use. This may advantageously provide a strong and symmetrical support to an additional brace element.

In accordance with a second aspect there is provided a brace for use with the sternum bar of the first aspect, the brace comprising: a lumbar supporting front plate configured to attach to the proximal end of the elongate means the sternum bar of any preceding claim, a back plate for providing support to the back; material connecting the back plate to the sternum bar, and the back plate to the lumbar supporting means; a chest/stomach strap for attaching the brace to the user. This may be advantageous for any of the reasons given above in relation to the features of the first aspect. In accordance with a third aspect there is provided a back brace comprising a proximal portion and a distal portion, wherein the proximal portion and the distal portion are jointed such that in use the proximal and distal portions pivot relative to one another. This may be particularly advantageous as this provides the user with additional flex in the back which may help limit discomfort and allow greater mobility. This back brace may be used in the second aspect.

Optionally, the distal portion is configured to comprise curved cut-outs at the distal end of the distal portion. The cut-outs may allow the back brace to be more ergonomic as this may improve flexibility of the user's shoulders whilst the back brace is in use.

Optionally, the cut-outs are offset from the centre of the distal end of the distal portion, such that the centre of the distal portion is complete, and the corners of the distal end of the distal section are removed by the cut-outs. This may be a particularly ergonomic configuration as this maximises the amount of back that is supported, whilst minimising constraint on user motion.

Optionally, the distal end of the distal portion is configured to sit between the shoulders of the user.

Brief Description

Figure 1 is a side view of the sternum bar in which both connection points are configured in a straight orientation.

Figure 2 is a side view of the sternum bar in which only the first connection point is in the bent configuration, whist the second connection point is in the straight orientation.

Figure 3 is a side view of the sternum bar in which both the connection points are in the bent orientation.

Figure 4 is a front view of the sternum bar in which both of the connection points are in the straight configuration.

Figure 5 is a rear view of the sternum bar in which both of the connection points are in the straight configuration.

Figure 6 is a perspective view of the sternum bar in which both of the connection points are in the straight configuration.

Figure 7 is a cross sectional view of a portion of the sternum bar. Figure 8 is a view of the cross section of a barrel joint.

Figure 9 is a view of the sternum bar when used as part of a thoracic spine brace.

Figure 10 shows an attachment element for attaching element 23 of Figure 9 to the back brace.

Figure 11 shows a first embodiment of a back brace element in a straight position.

Figure 12 shows the first embodiment of the back brace element in a bent position.

Figure 13 shows a second embodiment of the back brace element in a straight position.

Figure 14 shows the second embodiment of the back brace element in a bent position.

Detailed Description

Figure 1 shows a sternum bar. The sternum bar is for use in a thoracic spine brace. The sternum bar comprising an elongate bar comprising a proximal end and a distal end, a first connection point situated at the distal end of the elongate bar, a connecting element connected to the elongate bar via the first connection point, wherein the first connection point is adjacent a proximal end of the connection element, a second connection point situated at a distal end of the connection element, and a brace element connected to the second connection point and configured to provide support to the sternum of a user during use.

In particular Figure 1 shows an elongate bar 1. This elongate bar 1 has a proximal end at the bottom of the elongate bar (unattached to any other element in figure 1), and a distal end at the top of the elongate bar. The elongate bar may be any suitable dimensions, but in particular may be 20cm-30cm and may in particular be approximately 27cm long. The elongate bar is shown as being approximately cuboidal in shape.

Figure 1 shows that the elongate bar is connected to a first connection point 3. As shown in Figure 1 this first connection point 3 may be a joint style connection - and in particular may act as a first pivot point about which the bracing element 9 may pivot relative to the elongate bar 1. In the case of Figure 1 the first connection point uses a barrel style connection (which is shown in more detail in Figure 8).

The first connection point 3 is connected to a connecting element 5. The connecting element is shown as being an elongate bar 1 of approximately cuboidal shape. The connecting element may be any suitable length, for example between 3cm and 7cm, preferably around 4cm. As shown in Figure 1 the connecting element 5 comprises shoulders at both the proximal and distal ends with a central portion of reduced thickness. The shoulders are entirely optional, but may aid with providing a secure connection to the first connection point 3, and a second connection point 7.

The second connection point 7 is also shown in Figure 1. This is a further joint style connection, and is shown as providing a second pivot point for the bracing element 9 to pivot relative to the elongate bar 1. In the case of Figure 1 the second connection point uses a barrel style connection (which is shown in more detail in Figure 8).

The first and second connection points 3, 7 are shown as being parallel to one another. Whilst in some embodiments these connection points could have an angular offset, the parallel nature of these connection points is particularly advantageous. It enables the bracing element to remain centred along the axis of the elongate bar, whilst enabling the position of the bracing element in the other two axes to be adjusted for an individual user's needs. An angular offset between the connection points 3 and 7 if the user for example has a curved spine that means their sternum is off-centre.

In Figure 1 both of these connection points 3, 7 are shown in the straight position. That is the connection points 3, 7 are positioned to provide the longest overall length of the device in the longitudinal axis (in line with the length of the elongate bar 1). This may be the position in which the device is stored before use for example. The device may be used in this position if the user is particularly tall and thin.

Also shown in Figure 1 is a brace element 9. This is connected to the second connection point 7 (this connection may be direct, or indirect via a further connecting element similar to element 5). This brace element 9 is configured to be placed on the sternum of a user during use (this is shown in Figure 9).

Figure 2 shows the sternum bar of Figure 1. The difference between Figure 1 and Figure 2 is that the first connection point 3 is in the bent position. This means that the first connection point 3 is rotated such that the connection element 5, second connection point 7, and brace element 9 are rotated (in this case clockwise). In this configuration the brace element 9 faces downwards.

Figure 3 shows the sternum bar of Figures 1 and 2, but with both connection elements in the bent position. The first connection point 3 is in the same configuration shown in Figure 2. However, the second connection point 7 is also bent. This rotates the brace element 9 the other way (counter clockwise) such that the brace element 9 is parallel with (but offset from) the elongate bar 1 (the arrangement of Figure 1 also shows the brace element 9 and the elongate bar parallel with one another - however the offset between the elongate bar 1 and the brace element 9 is not present in Figure 1). The difference between Figures 1 and 3 is that the bending of the connection points 3 and 7 has positioned the brace element forward in the lateral direction (i.e. it is parallel but offset from the plane of the elongate bar 1). This is highly advantageous for fitting to a patient during use. The first and second connection points can each be set at a selected angle to achieve the required positioning of the brace element 9 for the selected patient. By adjusting both the first connection point 3 and second connection point 7 the brace element 9 can be manipulated to be raised/lowered in the vertical direction, as well the lateral offset between the elongate bar 1, and the brace element 9 being adjustable. As the sternum is usually central for a human there is no need to adjust in this direction in most cases. This means that patients of different body types (for example those with a higher proportion of body fat, or who are taller etc.) may all use the same sternum bar with the only adjustment needed being the angle of the first 3 and second 7 connection points. For example, for a taller user the bend of the first connection point and the second connection point may be low so that the length between the brace element 9 and the elongate bar is maximised. For a user with a high body fat percentage the lateral offset between the elongate bar 1 and the brace element may be maximised to ensure contact of the brace element 9 with the sternum. Therefore, the bend of the first connection point 3 and the second connection point 7 may be higher.

It is noted that the connection points 3 and 7 may be locked into position at a selected angle/bend so that once the user has selected particular angles (for a set position selected for the user's specific body type) the sternum bar can be locked to that position. The locking mechanism may comprise a button on each connection point 3, 7 that is pressed in to allow rotation of a selected connection point 3, 7 and then unpressed at the selected position. Once the button is unpressed the connection point 3, 7 is then locked. Other locking means may be used that are equivalent (and any such locking means is equivalent as long as it results in the connection point 3, 7 being locked at a selected position).

It is also noted that Figure 3 shows an apex formed at the intersection of the connection element 5 and the elongate bar 1 (at the connection point 3). This apex may be particularly advantageous for a patient/user as it forms a strong shape. The apex is configured to point away from the user's body when in use (the bracing element facing the user's body during use). As strong forces may be applied to the sternum bar the apex enables such forces to be withstood whilst still offering support to the user.

Figure 4 shows the sternum bar of Figures 1 to 3 in the straight position (as shown in figure 1). However, Figure 4 shows this from a frontal view of the sternum bar. This shows the elongate bar 1, the first connection point 3, the connecting element 5, and the bracing element 9 - as shown in the previous figures.

Figure 4 also shows that in some embodiments the connection points and bracing element are in a single plane, such that the bracing element is fixed within the centre of the axis of the elongate bar 1, but is free to move in the other two axes.

Also shown in Figure 4 are attachment means 11. In this case the attachment means comprises a series of attachment points 11. These attachment points 11 comprise a female element such as a hole. The attachment points are situated at different positions between the proximal and distal ends of the elongate bar 1. This enables an external device to be attached to the attachment points at a variety of different positions.

In this case the attachment points are specifically designed for attachment to a lumbar supporting means that may co-operate with the sternum bar to hold the user's torso in a pre-selected position. Attachment of the lumbar support to a selected attachment point 11 is based on the height of the user, and therefore the plurality of attachment points further enables the sternum bar to be used in a highly adjustable system for use with a particular patient (such as a very tall user).

Figure 4 also shows the brace element 9 comprising connection means 13. These connection means 13 comprise two holes either side of the elongate bar 1. These holes may connect the sternum bar to a further device, such as a neck brace or the like. It is noted that alternatives to holes may be used as connection means 13 and these are purely shown as an example of such means.

Figure 5 is a rear view of the sternum bar in the same position as Figure 4. This shows the face of the brace element 9 that contacts the sternum of the user. This is shown as comprising a flat surface around the edge of the brace element 9 and then a hollow centre. This may be particularly ergonomic to provide comfort the user during use. However alternative shaping may be used, such as a brace element 9 with a purely flat surface that does not have any hollow portion.

Figure 6 is a perspective view of the sternum bar of the previous Figures. This shows the same elements as shown in Figure 4, however this shows the relative depth of the elongate bar (and the other elements) relative to its width. The elongate bar is wider than it is deep, and is significantly longer than it is wide.

This Figure also shows the structure of the connection points 3 and 7 in more detail. In particular, the connection element 5 comprises four cylindrical projections (other shapes would also be equivalent) that fit within corresponding holes in the connection points 3, 7. The cylindrical projections are perpendicular to the length of the elongate bar 1. This connection element 5 is therefore held between the first connection point 3 and the second connection point 7. These connection points 3, 7 pivot about the cylindrical projections.

The pivoting of the connection points 3, 7 provides two degrees of freedom to the position of the bracing element 9 (as shown in Figure 2 - one degree of freedom utilised, and Figure 3 - both degrees of freedom utilised). These two degrees of freedom allow the adjustability of the sternum bar. It is also noted that these degrees of freedom are within the same plane (i.e. the connection points 3, 7 are aligned with the elongate bar 1).

It is also noted that the first connection point may be integrally formed at the distal end of the elongate bar 1. The second connection point 7 may be integrally formed on the rear of the bracing element 9.

Figure 7 shows a cross section of the elongate bar 1 and first connection point 3. This also shows the attachment means 11 (as attachment points along the length of the elongate bar 1). Approximate dimensions are shown in mm. These are merely exemplary for this specific embodiment.

Figure 8 is a close up of the portion of Figure 7 that shows the connection point 3. This shows the internal structure of the connection point. This comprises a central axis with a segmented outer structure. The segmented outer structure is then held within an outer casing. There are 10 segments shown - and each of these corresponds with a position the connection point may be locked into by the user. Alternate structures of connection point could of course be used. For example, more or less segments could be used, or a different structure allowing a continuum of positions for the user to select may be used. 10 segments may be optimal as this may offer the user enough positions to allow for the device to be personalised to their body shape. More segments may make the joint less strong and more liable to breakage in use (this may still be useful for some applications). It has been found that constructing the connection points from NAS 30 (RTM) increases the strength of the connection points, whilst allowing the number of segments to be optimised. The connecting element may also be made from this material for added robustness. The central axis will extend into the cylindrical projections and will form the axis about which the connection point 3 pivots.

Figure 9 shows the sternum bar in use. The attachment means 11 of the elongate bar 1 are attached to a lumbar supporting front plate 21. The lumbar supporting front plate 21 is therefore connected to the proximal end of the elongate bar 1. The lumbar supporting means may attach via side straps 23 to a back plate 30 for providing support to the back. Material 25 also connects the sternum bar to the back plate 30. Material 25 may be in the form of either side straps that go under the armpit of the user, or shoulder straps that go over the should of the use, alternatively both (or neither) of these may be used. A neck brace or collar may also attach to the sternum bar for an even more complete system. The user's torso fits between the lumbar supporting means/sternum bar and the back plate.

It is noted that straps 23 may form part of a belt that may be wide enough to encompass both straps (alternately just one strap may be used). A wide belt may be more comfortable and ergonomic for the user. The straps 23 may attach to the back plate 30 by any suitable means. This includes any suitable form of clasp or attachment means such as Velcro etc.

Figure 10 shows an exemplary attachment means 40 for attaching the straps 23 of Figure 9 with the back plate 30. This may be referred to as a back pulley panel 40. The back attachment means 40 may be stitched to the strap 23 at the connection point 44. One of these attachment means may be present either side of the back plate 30. The attachment means 40 may be attached to the back plate 30. Any belt (not shown in Figure 9 but discussed above) may fit through the aperture 46. The connection points 42 on either of the two attachment means may be connected together by means of a string, such as a nylon string. The nylon string may crisscross from one connection point 46 on one attachment element 40 to a second connection point 46 on the other attachment element 40, to form a taught connection between the two attachment elements 40. The attachment element 40 may be made from LDPE in order to have some additional flexibility to be ergonomic for the user during motion.

Figure 11 shows an example of a back brace/ back plate according to a first embodiment. The back brace is shown in two parts. The proximal portion 31 is position atop the distal portion 35 of the back brace. The proximal portion 31 and distal portions 35 are connected at a connection point 33. The proximal 31 and distal portions 35 of the back brace are configured to pivot relative to one another about this connection point 33. Figure 11 shows this embodiment of the back brace in a straight position with no back bend.

Figure 12 shows the back brace of Figure 10 with the proximal portion 31, the distal portion 35 and the connection point 33. However, Figure 12 shows the back brace in the bent configuration with the proximal portion 31 and the distal portions 35 bent at 10 degrees relative to one another. Alternative angular offsets may also be used - but 10 degrees may be advantageous as it may allow sufficient movement for the user, whilst still offering adequate support. This flex gives more comfort to the user, and allows the user greater freedom of movement.

Figure 13 shows an alternate embodiment of back brace. The proximal portion 37 has a curved cut-out shape at the far proximal end of the brace. This may be particularly advantageous because this shape may reduce any wear or tension build-up in the shoulders of the user. We note the cut-outs do not extend to the centre of the proximal portion 37. Instead the most proximal corner portions of the distal portion 37 are cut-out. We also note that the proximal portion 37 comprises a central strengthening bar. This may be in the form of a moulded bar (without any change in thickness of the material), or alternatively additional material and thickness may be added. This stiffening bar may be advantageous for ensuring the structural rigidity of the back brace element (whilst the connection point 33 still enables the flex to the user).

Figure 14 shows the back brace of Figure 12. The back brace in Figure 14 is however in the bent position wherein the distal 35 and proximal portions 37 of the back brace are bent relative to one another.

A method of making the above described devices may include injection moulding or any other suitable equivalent process.

The above embodiments are to be understood as illustrative examples. Further embodiments are also envisaged. It is to be understood that any feature described in relation to any one embodiment may be used alone, or in combination with other features described and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments.

Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the invention, which is defined in the accompanying claims. In some examples, one or more memory elements can store data and/or program instructions used to implement manufacture of devices described herein. Embodiments of the disclosure provide tangible, non-transitory storage media comprising program instructions operable to program a processor to said manufacture method and/or claimed herein.

The processor of such manufacturing apparatus (and any of the methods, activities or instructions outlined herein) may be implemented with fixed logic such as assemblies of logic gates or programmable logic such as software and/or computer program instructions executed by a processor. Other kinds of programmable logic include programmable processors, programmable digital logic (e.g. a field programmable gate array (FPGA), an erasable programmable read only memory (EPROM), an electrically erasable programmable read only memory (EEPROM), an application specific integrated circuit (ASIC) or any other kind of digital logic, software, code, electronic instructions, flash memory, optical disks, CD-ROMs, DVD ROMs, magnetic or optical cards, other types of machine-readable mediums suitable for storing electronic instructions, or any suitable combination thereof. Such data storage media may also provide the data storage of the manufacturing device.

Claims

1. A sternum bar for use in a thoracic spine brace, the sternum bar comprising: an elongate bar comprising a proximal end and a distal end; a first connection point situated at the distal end of the elongate bar; a connecting element connected to the elongate bar via the first connection point, wherein the first connection point is adjacent a proximal end of the connection element; a second connection point situated at a distal end of the connection element; a brace element connected to the second connection point and configured to provide support to the sternum of a user during use.

2. The sternum bar of claim 1, wherein in use the first connection point and the second connection point allow the elongate member and the connection element to form an apex pointing away from the user's body.

3. The sternum bar of claims 1 or 2, wherein the first connection point operates a joint style connection.

4. The sternum bar of claim 3, wherein the first connection point is configured to provide a first pivot point.

5. The sternum bar of claim 4, wherein the pivoting of the connection element relative to the elongate bar is in a single plane.

6. The sternum bar of any of claims 2 to 5, wherein the first connection point is a barrel joint.

7. The sternum bar of any preceding claim, wherein the first and second connection points are parallel with one another.

8. The sternum bar of any of claims 2 to 7, wherein the second connection point operates a joint style connection.

9. The sternum bar of claim 8, wherein the second connection point is configured to provide a second pivot point.

10. The sternum bar of claim 9, wherein the brace element relative to the connection element is in a single plane.

11. The sternum bar of claim 10, wherein the pivoting of the connection element relative to the elongate bar, and the pivoting of the brace element relative to the connection element are in the same plane.

12. The sternum bar of any preceding claim, wherein the first and second connection points provide two degrees of freedom.

13. The sternum bar of claim 12, wherein the two degrees of freedom are provided in the same plane.

14. The sternum bar of any preceding claim, wherein the elongate bar comprises an attachment means for attachment to a lumbar supporting means.

15. The sternum bar of claim 14, wherein the attachment means comprises a female element, such as a hole.

16. The sternum bar of claim 15, wherein the attachment means comprises a plurality of holes situated at different positions between the proximal and distal ends of the elongate member, such that the lumbar supporting means may attach to any one of the holes to enable adjustment of the device based upon height of the user.

17. The sternum bar of any preceding claim, wherein the brace element comprises connection means for attaching to an additional portion of the brace.

18. The sternum bar of claim 17, wherein the connection means comprises two holes situated either side of the sternum when in use.

19. A brace for use with the sternum bar of any preceding claim, the brace comprising: a lumbar supporting front plate configured to attach to the proximal end of the elongate means the sternum bar of any preceding claim, a back plate for providing support to the back; material connecting the back plate to the sternum bar, and the back plate to the lumbar supporting means; a chest/stomach strap for attaching the brace to the user.

20. A back brace comprising a proximal portion and a distal portion, wherein the proximal portion and the distal portion are jointed such that in use the proximal and distal portions pivot relative to one another.

21. The back brace of claim 20, wherein the distal portion is configured to comprise curved cut-outs at the distal end of the distal portion.

22. The back brace of claim 21, wherein the cut-outs are offset from the centre of the distal end of the distal portion, such that the centre of the distal portion is complete, and the corners of the distal end of the distal section are removed by the cut-outs.

23. The back brace of any of claims 20-22, wherein the proximal end of the distal portion is configured to sit between the shoulders of the user.

24. A method of manufacturing the device of any previous claim, comprising the steps of injection moulding the device of any preceding claim.