The present disclosure relates generally to orthoses, e.g. externally applied devices moving and/or stabilizing parts of an anatomical structure, such as a limb, across one or more anatomical joint(s) and/or an injury, such as to influence the structural and/or functional characteristics of the neuromuscular and skeletal system. For example, such as to allow immobilisation or stabilisation of an anatomical structure and pain relief and/or management thereof.
Anatomical structures include joints and bones, wherein joints connect bones and allow movement in the skeletal system. Injury to anatomical structures might involve bony structures, ligaments, muscle tears, tendon ruptures and more. Most injuries are stable and will heal without or with little compromise to the functional whole across the joint. However, certain injuries are severe and cause instability across the anatomical joint, requiring internal or external fixation (either through surgical stabilization or an external cast/brace) and/or reduction (e.g. in case of dislocation), and may require realignment and/or rehabilitation to restore optimal range of motion across the affected joint.
Conventionally, a plaster cast may be provided to immobilize and/or stabilize the injured limb. However, applying a plaster cast is a time consuming procedure and requires different tools as well as multiple healthcare provides. Furthermore, injured limbs may need multiple attempts of casting, which with a conventional plaster cast means starting over and hoping for a better second result.
Even more, when applying a plaster cast, the anatomical structure might be swollen (e.g. due to the injury). Hence, if applying a plaster cast, the cast may loosen due to reduction in swelling.
It is an object of the present disclosure to provide improvements of the prior art and/or to solve or reduce problems known from the prior art, such as, for example, the problems mentioned above. More particularly, it is an object of the present disclosure to provide a solution for management of an anatomical structure, which is easy to use, allows quick and precise fitting and/or enhances flexibility and adjustability. Effectively, the disclosed solution may reduce time spent on treatment of injured limbs as well as save costs, freeing up valuable healthcare resources.
Accordingly, a brace and a method for manufacturing the brace are disclosed. The brace is a brace for management of an anatomical structure comprising a primary anatomical structure, a secondary anatomical structure, and a joint and/or an injury between the primary anatomical structure and the secondary anatomical structure. The anatomical structure may be an injured anatomical structure.
The brace comprises a first brace part extending from a first primary brace part end to a first secondary brace part end and being adapted to be positioned to cover a first part of the anatomical structure extending over the joint and/or injury such that the first primary brace part end is located on the primary anatomical structure and the first secondary brace part end is located on the secondary anatomical structure.
The first brace part comprises a first rigid outer shell and one or more first lattice structures attached to a first inner side of the first rigid outer shell. The one or more first lattice structures have a first height in a height direction normal to the first inner side of the first rigid outer shell in a non-compressed state. The first height may be between 3 and 50 mm, such as between 5 and 30 mm, such as between 10 and 20 mm. The one or more first lattice structures are adapted to: in response to increasing compression from the non-compressed state to a first compression amount in the height direction, exhibit stress increasing at a first rate, and in response to increasing compression from the first compression amount to a second compression amount in the height direction, exhibit stress being uniform or increasing at a second rate lower than the first rate.
The first compression amount may correspond to 5% of the first height, such as less than 5% of the first height. The second compression amount may correspond to more than 50% of the first height, such as 50%. 60%, 70%, 80% or 90% of the first height, or more than 60%, 70%, 80% or 90% of the first height. The second rate of stress increase between the first compression amount and the second compression amount may be less than 50%, such as less than 25%, such as less than 10%, such as less than 5%, such as less than 1% of the first rate of stress increase.
The one or more first lattice structures are further adapted to, in response to decreasing compression from the first compression amount and/or the second compression amount to the non-compressed state, return to the first height, e.g. within a predetermined time period. The predetermined time period may be less than 30 minutes, such as less than 10 minutes, such as less than 1 minute, such as less than 30 seconds, such as less than 10 seconds, such as less than 1 second, such as less than 0.5 seconds.
The first compression amount and/or the second compression amount corresponds to a deformation which is reversible and non-permanent. Thus, in response to decreasing compression from the first compression amount and/or from the second compression amount, the one or more lattice structures return to their initial heights, i.e., the first height.
The first compression amount may correspond to a stress, such as applied pressure, between 5-40 mmHg, such as between 10-36 mmHg, such as between 15-20 mmHg. The second compression amount may correspond to a pressure between 5-40 mmHg, such as between 10-36 mmHg, such as between 15-20 mmHg.
The one or more first lattice structures includes a first primary lattice structure covering a first primary region and a first secondary lattice structure covering a first secondary region. The average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region is lower than the average stress exhibited by the first secondary lattice structure in response to compression between the first compression amount and the second compression amount in the first secondary region.
As mentioned, a method for manufacturing a brace for management of the anatomical structure, such as the brace as disclosed above, is also disclosed.
The method comprises providing a first rigid outer shell for a first brace part of the brace extending from a first primary brace part end to a first secondary brace part end, wherein the first brace part is adapted to be positioned to cover a first part of the anatomical structure extending over the joint and/or injury such that the first primary brace part end is located on the primary anatomical structure and the first secondary brace part end is located on the secondary anatomical structure.
The method further comprises forming one or more first lattice structures having a first height in a height direction in a non-compressed state. The one or more first lattice structures are adapted to: in response to increasing compression from the non-compressed state to a first compression amount in the height direction, exhibit stress increasing at a first rate, and in response to increasing compression from the first compression amount to a second compression amount in the height direction, exhibit stress being uniform or increasing at a second rate lower than the first rate.
The first compression amount may correspond to 5% of the first height, such as less than 5% of the first height. The second compression amount may correspond to more than 50% of the first height, such as 50%. 60%, 70%, 80% or 90% of the first height, or more than 60%, 70%, 80% or 90% of the first height. The second rate of stress increase between the first compression amount and the second compression amount may be less than 50%, such as less than 25%, such as less than 10%, such as less than 5%, such as less than 1% of the first rate of stress increase.
The one or more first lattice structures are further adapted to, in response to decreasing compression from the first compression amount and/or the second compression amount to the non-compressed state, return to the first height, e.g. within a predetermined time period. The predetermined time period may be less than 30 minutes, such as less than 10 minutes, such as less than 1 minute, such as less than 30 seconds, such as less than 10 seconds, such as less than 1 second, such as less than 0.5 seconds. The one or more first lattice structures are formed to include a first primary lattice structure covering a first primary region and a first secondary lattice structure covering a first secondary region, wherein the average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region is lower than the average stress exhibited by the first secondary lattice structure in response to compression between the first compression amount and the second compression amount in the first secondary region.
The method further comprises attaching the one or more first lattice structures to a first inner side of the first rigid outer shell, such that the height direction of the one or more first lattice structures are arranged normal to the first inner side of the first rigid outer shell.
The present disclosure provides a solution, which is quick and easy to use, is precise and adjustable, and which can be applied without any extra tools. Furthermore, the present disclosure provides for faster and more standardized manufacturing of a brace for managing an (injured) anatomical structure. It is a further advantage of the present disclosure that a brace may be provided, which reduces patient discomfort while recovering from an injury. The present disclosure further reduces the need for more complex procedures, such as surgical interventions, caused by inefficient immobilization or stabilising of an injured anatomical structure.
The brace may comprise a second brace part extending from a second primary brace part end to a second secondary brace part end. The second brace part may be adapted to be positioned to cover a second part of the anatomical structure. The second part of the anatomical structure may be opposite the first part of the anatomical structure. The second brace part may be adapted to be positioned to cover the second part of the anatomical structure extending over the joint and/or injury such that the second primary brace part end is located on the primary anatomical structure and the second secondary brace part end is located on the secondary anatomical structure. The second brace part may comprise a second rigid outer shell. Accordingly, the method may comprise providing such second rigid outer shell for the second brace part of the brace.
In some examples, the second brace part may be without a lattice structure, i.e. providing a hard shell to be positioned to cover the second part of the anatomical structure. Alternatively, the second brace part may comprise one or more second lattice structures attached to a second inner side of the second rigid outer shell. The one or more second lattice structures may have a second height in a height direction normal to the second inner side of the second rigid outer shell in a non-compressed state. The second height may be between 3 and 50 mm, such as between 5 and 30 mm, such as between 10 and 20 mm. Furthermore, like for the one or more first lattice structures, the one or more second lattice structures may be adapted to: in response to increasing compression from the non-compressed state to a primary compression amount in the height direction, exhibit stress increasing at a primary rate, and in response to increasing compression from the primary compression amount to a secondary compression amount in the height direction, exhibit stress being uniform or increasing at a secondary rate lower than the primary rate.
The primary compression amount may correspond to 5% of the second height, such as less than 5% of the second height. The secondary compression amount may correspond to more than 50% of the second height, such as 50%. 60%, 70%, 80% or 90% of the second height, or more than 60%, 70%, 80% or 90% of the second height. The secondary rate of stress increase between the primary compression amount and the secondary compression amount may be less than 50%, such as less than 25%, such as less than 10%, such as less than 5%, such as less than 1% of the primary rate of stress increase.
The one or more second lattice structures may further be adapted to, in response to decreasing compression from the primary compression amount and/or the secondary compression amount to the non-compressed state, return to the second height, e.g. within a predetermined time period, which may be similar to the predetermined time period as described in relation to the one or more first lattice structures.
The primary compression amount and/or the secondary compression amount corresponds a deformation which is reversible and non-permanent. Thus, in response to decreasing compression from the primary compression amount and/or secondary compression amount, the one or more lattice structures return to their initial heights, i.e. the second height.
The primary compression amount may correspond to a stress, such as applied pressure, between 5-40 mmHg, such as between 10-36 mmHg, such as between 15-20 mmHg. The secondary compression amount may correspond to a pressure between 5-40 mmHg, such as between 10-36 mmHg, such as between 15-20 mmHg.
The one or more second lattice structures may be formed to include a second primary lattice structure covering a second primary region and a second secondary lattice structure covering a second secondary region. The average stress exhibited by the second primary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second primary region may be lower than the average stress exhibited by the second secondary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second secondary region.
The first rigid outer shell and/or the second rigid outer shell may be formed to fit the anatomical structure. The first inner side of the first rigid outer shell and/or the second inner side of the second rigid outer shell may be concave, such as to at least partially enclose the respective part of the anatomical structure, i.e. the first part or the second part of the anatomical structure. The first rigid outer shell and/or the second rigid outer shell may, for example, be made of polyurethane or polypropylene.
The brace may be adapted to be positioned on the anatomical structure such that the first primary region and/or the second primary region is positioned on a part of the anatomical structure having a bony prominence. Alternatively or additionally, the brace may be adapted to be positioned on the anatomical structure such that the first secondary region and/or the second secondary region is positioned on a part of the anatomical structure with soft tissue.
The brace may be adapted to be positioned on the anatomical structure such that the first primary region and/or the second primary region is positioned closer to the joint and/or injury of the anatomical structure than the first secondary region and/or the second secondary region. For example, the brace may be adapted to be positioned on the anatomical structure such that the first primary region and/or the second primary region is positioned over the joint and/or over the injury.
The brace may be adapted to be positioned on the anatomical structure such that harder regions, e.g. the first primary region, the second primary region and optionally further regions, are located to provide for a sufficient three-point fixation of the injury of the anatomical structure.
The one or more first lattice structures may include a first tertiary lattice structure. The first tertiary lattice structure may cover a first tertiary region. The average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region may be lower than the average stress exhibited by the first tertiary lattice structure in response to compression between the first compression amount and the second compression amount in the first tertiary region. The average stress exhibited by the first tertiary lattice structure in response to compression between the first compression amount and the second compression amount in the first tertiary region may be between the average stress exhibited by the first primary lattice structure in response to compression between the first compression amount and the second compression amount in the first primary region and the average stress exhibited by the first secondary lattice structure in response to compression between the first compression amount and the second compression amount in the first secondary region.
The one or more second lattice structures may include a second tertiary lattice structure. The second tertiary lattice structure may cover a second tertiary region. The average stress exhibited by the second primary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second primary region may be lower than the average stress exhibited by the second tertiary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second tertiary region. The average stress exhibited by the second tertiary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second tertiary region may be between the average stress exhibited by the second primary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second primary region and the average stress exhibited by the second secondary lattice structure in response to compression between the primary compression amount and the secondary compression amount in the second secondary region.
The first primary lattice structure and the first secondary lattice structure and optionally the first tertiary lattice structure may be independently manufactured lattice structures. Alternatively or additionally, the second primary lattice structure and the second secondary lattice structure and optionally the second tertiary lattice structure may be independently manufactured lattice structures. The independently manufactured lattice structures may be attached to their respective rigid outer shell to form the one or more lattice structures.
Alternatively, the one or more first lattice structures may be integrally formed. For example, the first primary lattice structure and the first secondary lattice structure and optionally the first tertiary lattice structure may be integrally formed. Alternatively or additionally, the one or more second lattice structures may be integrally formed. For example, the second primary lattice structure and the second secondary lattice structure and optionally the second tertiary lattice structure may be integrally formed. For example, forming the one or more first lattice structures may comprise forming a single first lattice structure comprising the first primary lattice structure and the first secondary lattice structure and optionally the first tertiary lattice structure. The single first lattice structure may be adapted to extend from the first primary brace part end to the first secondary brace part end. Alternatively or additionally, forming the one or more second lattice structures may comprise forming a single second lattice structure comprising the second primary lattice structure and the second secondary lattice structure and optionally the second tertiary lattice structure. The single second lattice structure may be adapted to extend from the second primary brace part end to the second secondary brace part end.
The one or more first lattice structures and/or the one or more second lattice structures may be elastomeric and/or polymeric lattice structures. For example, the one or more first lattice structures and/or the one or more second lattice structures may be made of polyurethane, such as a polyurethane elastomer. The one or more first lattice structures may comprise a plurality of interconnected flexible struts, which may form repeating unit cells. The unit cells may be triangular, quadratic, pentagonal, hexagonal, or other geometric shapes.
The one or more first lattice structures and/or the one or more second lattice structures may be formed by additive manufacturing, such as 3D printing and/or resin printing. For example, the one or more first lattice structures may be formed by selective laser sintering and/or by digital light synthesis (DLS) of Carbon Inc. An exemplary process for forming the one or more first and/or second lattice structures may be found in US 2018/0264718 A1. Accordingly, the one or more first and/or second lattice structures may be in accordance with the lattices of US 2018/0264718 A1.
The lattice structures may differ by their geometrical shape, their thickness of struts, and/or their length of struts. For example, the first primary lattice structure may differ from the first secondary lattice structure, the first primary lattice structure may differ from the first tertiary lattice structure, and/or the first secondary lattice structure may differ from the first tertiary lattice structure, e.g. by their geometrical shape, their thickness of struts, and/or their length of struts. The second primary lattice structure may differ from the second secondary lattice structure, the second primary lattice structure may differ from the second tertiary lattice structure, and/or the second secondary lattice structure may differ from the second tertiary lattice structure, e.g. by their geometrical shape, their thickness of struts, and/or their length of struts. The thickness (e.g. diameter) of struts may be between 0.1 mm and 1 mm. The length of struts may be between 0.5 mm and 10 mm, such as between 1 mm and 5 mm, such as between 1 mm and 2 mm.
Geometrical shape, thickness of struts, and/or length of struts of the first primary lattice structure, the first secondary lattice structure, the first tertiary lattice structure, the second primary lattice structure, the second secondary lattice structure, and/or the second tertiary lattice structure may vary along the height direction.
The brace may comprise one or more fasteners adapted to fasten the brace to the anatomical structure. The one or more fasteners may include one or more straps. The fasteners, such as the straps, may include hook and loop fasteners. The fasteners, such as the straps, may facilitate incrementally tightening or loosening the fastening of the brace to the anatomical structure. The fasteners, such as the straps, may allow for easy opening and re-closure, such as to allow repositioning of the brace. The one or more fasteners, such as the straps, may be adapted to fasten the first brace part to the second brace part, e.g. so as to fasten the brace around the anatomical structure.
The method for manufacturing the brace may comprise obtaining a three-dimensional model of the anatomical structure, e.g. including the location of the joint and/or the injury. Forming the one or more first lattice structures and/or the one or more second lattice structures may be based on the three-dimensional model. The three-dimensional model may include information of tissue type at a plurality of locations of the anatomical structure, such as positions of bony prominences, soft tissue, ligaments, superficial nerves etc. Forming the one or more first lattice structures and/or attaching the one or more first lattice structures to the first inner side of the first rigid outer shell may comprise arranging the first primary region to cover a part of the anatomical structure having one or more bony prominences and/or arranging the first secondary region to cover a part of the anatomical structure having soft tissue. Forming the one or more second lattice structures and/or attaching the one or more second lattice structures to the second inner side of the second rigid outer shell may comprise arranging the second primary region to cover a part of the anatomical structure having one or more bony prominences and/or arranging the second secondary region to cover a part of the anatomical structure having soft tissue.
Embodiments of the disclosure will be described in more detail in the following with regard to the accompanying figures. The figures show one way of implementing the present disclosure and are not to be construed as being limiting to other possible embodiments falling within the scope of the attached claim set.
Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.
The anatomical structure 70 comprises a primary anatomical structure 72, e.g. the forearm, and a secondary anatomical structure 74, e.g. the hand. The anatomical structure 70 further comprises a joint 76, e.g. the wrist and/or an injury 78, e.g. a bone fracture, tissue damage, or similar. The joint 76 and/or the injury 78 is located between the primary anatomical structure 72 and the secondary anatomical structure 74.
The first brace part 10 comprises a first rigid outer shell 16. The first rigid outer shell 16 is sufficiently rigid to provide the necessary stability of the brace 2 to support the anatomical structure 70. The first rigid outer shell 16 comprises a first inner side 18. The first inner side 18 is concave to at least partially enclose the first part 80 of the anatomical structure 70. The first brace part 10 further comprises one or more first lattice structures 20 attached to the first inner side 18 of the first rigid outer shell 16. The one or more first lattice structures 20 may be elastomeric and/or polymeric lattice structures. In some examples, the one or more first lattice structures 20 may be divided into a plurality of individually manufactured portions each being attached to the first inner side 18. In other examples, the one or more first lattice structures 20 may be formed by a single lattice structure extending from the first primary brace part end 12 to the first secondary brace part end 14. The one or more first lattice structures 20 may be attached to the first inner side 18 by gluing, by hooks and loops, or by another attachment method known in the art. The one or more first lattice structures 20 may be only lightly attached, as the positioning of the brace 2 on the anatomical structure will help maintain the position of the one or more first lattice structures 20 with respect to the first rigid outer shell 16.
The brace 2, as exemplified in
The second brace part 40 comprises a second rigid outer shell 46. The second rigid outer shell 46 is sufficiently rigid to provide the necessary stability of the brace 2 to support the anatomical structure 70. The second rigid outer shell 46 comprises a second inner side 48. The second inner side 48 is concave to at least partially enclose the second part 82 of the anatomical structure 70. The second brace part 40 further comprises one or more second lattice structures 50 attached to the second inner side 48 of the second rigid outer shell 46. The one or more second lattice structures 50 may be elastomeric and/or polymeric lattice structures. In some examples, the one or more second lattice structures 50 may be divided into a plurality of individually manufactured portions each being attached to the second inner side 48. In other examples, the one or more second lattice structures 50 may be formed by a single lattice structure extending from the second primary brace part end 42 to the second secondary brace part end 44. The one or more second lattice structures 50 may be attached to the second inner side 48 by gluing, by hooks and loops, or by another attachment method known in the art. The one or more second lattice structures 50 may be only lightly attached, as the positioning of the brace 2 on the anatomical structure will help maintain the position of the one or more second lattice structures 50 with respect to the second rigid outer shell 46.
In some examples, the second brace part 40 may omit the one or more second lattice structures 50 (see
The brace 2 comprises fasteners 4 adapted to fasten the brace 2 to the anatomical structure 70. For example, the fasteners may include straps, such as hook and loop straps. The fasteners 4 may facilitate incrementally tightening or loosening of the brace. The fasteners 4, in the illustrated example, are adapted to fasten the first brace part 10 to the second brace part 40, so as to fasten the brace 2 around the anatomical structure 70. In some examples, e.g. if omitting the second brace part 40, the fasteners 4 may fasten the brace 2 directly to the anatomical structure 70, e.g. by the fasteners extending from one side of the first brace part 10 and around the anatomical structure 70 to the opposite side of the first brace part 10.
The stress strain relationship is illustrated in
The second compression amount c2 may correspond to more than 50% compression, such as 50%. 60%, 70%, 80% or 90% compression, or more than 60%, 70%, 80% or 90% compression.
When being further compressed beyond the second compression amount c2, the lattice structures 20, 50 may exhibit stress increasing at a third rate. For the purpose of the brace as disclosed herein, it is intended that the lattice structures are compressed to between the first compression amount c1 and the second compression amount c2, when being fastened to the anatomical structure. Thereby, substantially the same pressure will be applied to the anatomical structure even if swelling is reduced or if swelling occurs after applying the brace.
The greyed area in the middle of the graphs in
The one or more lattice structures 20, 50 comprises a plurality of regions including a primary region 24, 54 and a secondary region 26, 56. The plurality of regions may further comprise a tertiary region 28, 58. These regions may differ by being provided with different hardness, i.e. exhibiting different stress in the plateau zone, as explained in relation with
The differing hardness in the different regions is achieved by the lattice structures 20, 50 comprising different lattice structures in the different regions. Some examples, of different lattice structures are provided in
The lattice structures 20, 50 may include a tertiary lattice structure 20C, 50C, as illustrated in
Although not specifically illustrated, it is noted that the lattice structures, such as their geometrical shape, thickness of struts, and/or length of struts, may vary along the height of the lattice structure, i.e. along the height direction h1 (cf.
Although being described collectively with reference to
Although not specifically illustrated in
The disclosure has been described with reference to a preferred embodiment. However, the scope of the invention is not limited to the illustrated embodiment, and alterations and modifications can be carried out without deviating from the scope of the invention.
Throughout the description, the use of the terms “first”, “second”, “third”, “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order or importance but are included to identify individual elements. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa.
Number | Date | Country | Kind |
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22156131.9 | Feb 2022 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2023/052582 | 2/2/2023 | WO |