Orthosis for encompassing an extremity

Abstract

The invention relates to an orthosis for encompassing an extremity, which extends in a proximal-distal direction and has a circumference, wherein the orthosis has a rigid region (2) and a flexible region (8), wherein the rigid region (2) has a longitudinal portion (4) that extends in the proximal-distal direction and on which is arranged a circumferential portion (6) that extends in the circumferential direction, wherein the longitudinal portion (4) is connected to the circumferential portion (6) such that the circumferential portion (6) lies dorsally against the extremity when the orthosis is put on, wherein the flexible region (8) adjoins the longitudinal portion (4) and the circumferential portion (6) of the rigid portion (2) in the circumferential direction.

Description

[0001] Ottobock SE & Co. KGaA Attorney's file: Max-Näder-Straße 15 0108-2056 PCT-1 37115 Duderstadt Germany Date:

[0002] September 18, 2025

[0003] Orthosis for enclosing an extremity

[0004] The invention relates to an orthosis for enclosing an extremity that extends in a proximal-distal direction and has a circumference.

[0005] Such orthoses have long been known in the art and are used for various extremities, for example, upper arms, forearms, thighs, or lower legs. The orthosis is applied to the extremity and preferably covers it completely, i.e., along its entire circumference. Within the scope of the present invention, "covering an extremity" preferably means that at least 75%, preferably at least 85%, particularly preferably at least 95%, and most preferably 100% of the extremity's circumference is covered by the orthosis.

[0006] Such orthoses are known, for example, from US 6,893,411 B1. The orthosis described therein has three components that are connected to each other circumferentially around the extremity, for example, by hook-and-loop fasteners. A first end piece connects to a splint system of the orthosis, which rests on the wearer's body at several points on one or more extremities and preferably spans a joint. This joint often needs to be protected, exercised, or supported. Attached to this first end piece is a central piece extending circumferentially around the extremity, which has a pocket in which a stabilizing rigid element, such as a metal splint, can be placed. A second end piece is attached to the end of this central piece opposite the first end piece and is also detachable, for example, by means of hook-and-loop fasteners.Straps are attached to one of the two ends of the orthosis, used to secure it to the body part. The other end of the orthosis has guide loops through which the straps can be threaded and looped back onto themselves. The straps are used in this way to exert sufficient pressure on the orthosis so that it stays in place on the wearer's limb. A disadvantage is that such an orthosis has a relatively complex design and is therefore expensive to manufacture. Furthermore, different sizes must be available for different wearers to accommodate individual needs, such as the circumference of a thigh.

[0007] An alternative embodiment of an orthosis can be found, for example, in EP 1 697 052 ​​A1. This orthosis has a rigid, semicircular shell that extends around the extremity to which the orthosis is to be applied. This rigid shell forms the orthotic body, which does not encompass the extremity but only rests against it around approximately half its circumference. This orthosis is also held in place by straps used to secure this orthotic body to the extremity. A disadvantage here is that the rigid shell necessitates a precise fit of the orthosis to the size, particularly the circumference, of the extremity. Furthermore, in the area where the shell does not rest against the extremity but where the straps make contact, significant pressure is exerted on the extremity, which can be uncomfortable for the wearer and may lead to pressure sores and pain.

[0008] Both types of orthoses are hardly suitable for responding to volume fluctuations of the extremity. They can, at best, only be adjusted to a limited extent, either enlarged or reduced, to accommodate the fluctuations that an extremity experiences, particularly in the first few months after treatment, such as surgery. The invention therefore aims to propose a simple orthosis that is easily adapted to different extremity dimensions while still ensuring good stability during various extremity movements.

[0009] The invention solves the stated problem by means of an orthosis for enclosing an extremity which extends in a proximal-distal direction and has a circumference, wherein the orthosis has a rigid area and a flexible area, wherein the rigid area has a longitudinal portion which extends in a proximal-distal direction, to which a circumferential portion is arranged which extends in the circumferential direction, wherein the longitudinal portion is connected to the circumferential portion in such a way that the circumferential portion lies dorsally against the extremity when the orthosis is applied, wherein the flexible area connects in the circumferential direction to the longitudinal portion and the circumferential portion of the rigid area.

[0010] The orthosis according to the invention therefore has a rigid section that provides the necessary stability. This rigid section has a longitudinal portion that extends in a proximal-distal direction, i.e., along the extremity. This longitudinal portion is larger in the proximal-distal direction than in the circumferential direction. It can be rectangular, oval, cigar-shaped, or individually shaped.

[0011] The circumferential portion of the rigid section is located on this longitudinal portion. This circumferential portion extends in the circumferential direction, meaning it has a greater extent circumferentially than in the proximal-distal direction. This does not necessarily mean that there is a right angle between the longitudinal and circumferential portions; an acute or obtuse angle is also possible. The circumferential portion extends dorsally, i.e., at the back, of the extremity. For example, in the case of a thigh orthosis, the circumferential portion runs behind the thigh, while the longitudinal portion preferably runs laterally, i.e., on the outside, of the thigh. This ensures that the orthosis cannot twist when sitting down and can bear weight even in this position. Preferably, the longitudinal and circumferential portions are formed as a single piece. Preferably, the rigid section has a substantially "L"-shaped form.

[0012] The orthosis according to the invention also has a flexible section. This flexible section preferably extends over the remainder of the circumference of the extremity not covered by the rigid section. It is important that the flexible section connects to both the longitudinal and circumferential portions of the rigid section in the circumferential direction. In a particularly preferred embodiment, this eliminates the need for any further rigid elements, thus making it particularly easy to accommodate different sizes of the respective extremities, for example, due to the individual characteristics of different wearers of the orthosis.

[0013] Preferably, the longitudinal portion is arranged laterally on the extremity when the orthosis is applied.

[0014] In a preferred embodiment, the end of the circumferential portion furthest from the longitudinal portion is located closer to the medial side of the extremity than to the lateral side. Alternatively, when the orthosis is applied, the end of the circumferential portion furthest from the longitudinal portion is located equally close to the lateral and medial sides of the extremity. In other words, the circumferential portion extends from its end closest to the longitudinal portion, where it is attached to the longitudinal portion, to its end furthest from the longitudinal portion, at least to the midpoint of the extremity, which lies exactly between the medial and lateral sides. Preferably, the circumferential portion extends beyond this midpoint to the opposite side of the extremity.If the longitudinal portion is arranged laterally, the circumferential portion extends beyond the midpoint of the extremity, so that the end of the circumferential portion furthest from the longitudinal portion is located closer to the medial side of the extremity. Conversely, if the longitudinal portion is arranged medially, the circumferential portion extends beyond the midpoint of the extremity, so that the end of the circumferential portion furthest from the longitudinal portion is located closer to the lateral side of the extremity.

[0015] Preferably, the circumferential portion is arranged in the distal region of the longitudinal portion, preferably at its distal end. This forms an approximately L-shaped structure consisting of the longitudinal portion extending in a proximal-distal direction and the circumferential portion extending in the circumferential direction.

[0016] Advantageously, the rigid and flexible sections of the orthosis are formed in one piece. This is particularly easy to achieve, for example, if both sections are made of so-called "prepregs," which are layers of a material, such as a fabric, impregnated or coated with a synthetic resin. Depending on the fabric used, both the longitudinal section, for example, as a carbon fiber composite element, and the circumferential section as a flexible element can be produced in this way. If the same synthetic resin is used for both sections and they are cured together, a material-bonded connection is formed, which in this case is referred to as "one-piece."

[0017] Preferably, the flexible section is made of Dyneema fibers. The fabric used to manufacture the prepregs is also made of Dyneema fibers. Preferably, polyethylene-based fibers are used, preferably those with a particularly high molecular weight (ultra-high-molecular-weight polyethylene (PE-UHMW) or high-modulus polyethylene (HMPE)).

[0018] Preferably, when the orthosis is applied, the end of the flexible section facing away from the rigid section is positioned between the rigid section and the extremity. This means that the orthosis is longer than the circumference of the extremity, so that the two ends overlap circumferentially. When applying the orthosis, the end containing the rigid section is first placed against the extremity. Then, the flexible section is wrapped around the extremity until the end of the flexible section facing away from the rigid section overlaps it. This end of the flexible section is then tucked between the extremity and the rigid section of the orthosis during application.Since this can be done to varying degrees, it is particularly easy in this way to compensate for volume fluctuations of the extremity, for example of a thigh, by inserting the end of the flexible part of the orthosis that is furthest away from the rigid part to a different extent between the extremity and the rigid part of the orthosis.

[0019] Preferably, the orthosis has at least one strap that connects the rigid section to the flexible section and preferably runs frontally along the extremity when the orthosis is applied. Preferably, several straps, for example two or three, are present that connect the two sections of the orthosis.

[0020] It has proven advantageous for the flexible section to have a rigid anchor element to which the at least one strap is attached. Preferably, all straps are attached to the rigid anchor element of the flexible section of the orthosis. Particularly preferably, one end of the at least one strap is fixed to the anchor element, or the anchor element has a deflection eyelet through which the at least one strap is passed. The strap can then be folded back on itself and fastened, for example, by means of positive locking elements such as hook-and-loop fasteners. Particularly preferably, all straps are designed in this way. Preferably, the anchor element is positioned medially on the extremity when the orthosis is applied.

[0021] In a preferred embodiment, the flexible region had a greater proximal-distal extent at its end facing away from the rigid region than at its end facing the rigid region. Advantageously, the flexible region has an extent at its end facing away from the rigid region that corresponds to the proximal-distal extent of the rigid region.

[0022] Preferably, the flexible area is at least partially, but more preferably entirely, made of a material that can be cut with scissors, except for an anchor area. In this way, the extent of the orthosis can preferably be varied both circumferentially and proximal-distal, adapting it to the individual characteristics of the wearer's extremity. This eliminates the need, inherent in prior art orthoses, to stock a large number of different sizes for different individuals and wearers.

[0023] Preferably, a connecting line between the flexible area and the rigid area is at least partially, and preferably completely, covered by at least one layer of film. According to the invention, the flexible area adjoins the rigid area. Consequently, there is a connecting line between the two areas, along which the two areas are joined. This connecting line is at least partially covered by at least one layer of film. Preferably, the connecting line is completely covered by at least one layer of film. It is not necessary, but advantageous, if each layer of film consists of a single piece of film. It is also possible, and in some cases advantageous, to arrange several pieces of film such that they each cover the connecting line along a section. The pieces of film can be made of the same or different types of film.

[0024] The film preferably contains or is made from uncrosslinked rubber. Such a film is available on the market under the trade name "KRAIBON". During the manufacturing process, the film preferably cures together with the resin used to produce the rigid and / or flexible areas. Preferably, the film is bonded to both the flexible and rigid areas, preferably by a metallurgical bond, and most preferably in one piece.

[0025] The film covers an edge of the rigid area, for example, made of rigid carbon fiber composite material, which could otherwise protrude, particularly under peel loads. Preferably, the film has a width of at most 25 mm, more preferably at most 20 mm, more preferably 15 mm, and at least 5 mm, more preferably at least 10 mm. The Shore hardness of the film is preferably at least 54 Shore A, more preferably at least 59 Shore A, more preferably 64 Shore A, and at most 74 Shore A, more preferably at most 69 Shore A.

[0026] Preferably, at least one layer of film is arranged on the side facing the extremity and / or the side facing away from the extremity. Particularly preferably, at least one layer of film is arranged on both the side facing the extremity and the side facing away from the extremity.

[0027] With the aid of the accompanying figures, an embodiment of the present invention is explained in more detail below. The figures show:

[0028] Figure 1 - an orthosis according to a first embodiment in the open state,

[0029] Figures 2 and 3 - the orthosis from Figure 1 in the closed state in different views and

[0030] Figures 4 and 5 - the schematic representation of an orthosis according to further embodiments of the present invention.

[0031] Figure 6 - an orthosis according to a further embodiment of the present invention and Figure 7 - an orthosis according to a further embodiment of the present invention in the applied state.

[0032] Figure 1 shows an orthosis according to a first embodiment of the present invention. It has a rigid section 2 comprising a longitudinal portion 4 and a circumferential portion 6. The longitudinal portion 4 extends in a proximal-distal direction along the extremity to which the orthosis is to be applied. The circumferential portion 6 is located in the distal region of the longitudinal portion 4 and is formed integrally with it. A flexible section 8 adjoins the longitudinal portion 4 and the circumferential portion 6 and, in the illustrated embodiment, is formed integrally with the rigid section 2. Three straps 10 are arranged on the rigid section 2. The flexible section 8 has an anchor element 12 on which three deflection loops 14 are shown. When the orthosis is applied, the straps 10 are guided through these deflection loops 14 and can then be secured to themselves by means of positive locking elements arranged at the ends of the straps.

[0033] Figures 2 and 3 show the orthosis from Figure 1 in its connected state. Figure 2 shows a more lateral view. The straps 10 are visible, their ends secured to themselves. It is clearly evident that the uppermost strap 10, which runs proximally, is not parallel to the two lower, i.e., the two distal, straps 10. This is due to the fact that, as already seen in Figure 1, the anchor element 12 has a smaller proximal-distal extension than the longitudinal portion 4 of the rigid section 2. This is clearly visible in Figure 3, as Figure 3 shows a more medial view.

[0034] Figure 4 shows the orthosis "unrolled." The longitudinal section 4, the circumferential section 6, and the flexible section 8 are clearly visible. The orthosis in Figure 4 is designed for an extremity that does not have a constant diameter in the proximal-distal direction. This could be, for example, a thigh whose circumference is larger in the proximal region (towards the hip) than in the distal region (towards the knee). When such an orthosis is unrolled, the proximal-distal direction varies across different areas of the orthosis. In Figure 4, this is indicated by a dashed line with the reference symbol 18. It is clearly visible that the flexible section 8, at its end 16 furthest from the rigid section 2, has approximately the same proximal-distal extent 18 as the longitudinal section 4. In the area between, the flexible section 8 has a smaller proximal-distal extent.The flexible area 8 is connected to the rigid area 2 along a connecting line 20.

[0035] Figure 5, like Figure 4, shows an “unrolled” orthosis, but in contrast to the orthosis shown in Figure 4, in the embodiment shown in Figure 5 the connecting line 20 is covered by a layer of film 22, which in the illustrated embodiment is located on the side of the orthosis facing away from the extremity, i.e. “outside”.

[0036] Figure 5 shows an orthosis comprising a thigh orthosis of the type described herein. This forms a first shell of the orthosis, encompassing the thigh. This first shell has a first connection area 24 to which a first fitting part 26 is arranged. The first fitting part 26 is connected to a second fitting part 28. In this embodiment, the two fitting parts together form a joint 30. The second fitting part 28 is arranged at a second connection area 32 of a second shell 34. A splint 36 is arranged on the second shell 34, which is designed as a lower leg shell, and an ankle joint 38 is attached to this splint. The orthosis shown in Figure 6 has a foot section 40, which is arranged at the ankle joint 38 and is therefore pivotable relative to the second shell 34.Such ankle joints can have spring elements by which a pivoting movement is spring-loaded, at least from a predetermined pivoting angle. The springs and their resulting force can be different or identical for both pivoting directions. Such ankle joints are known, for example, from DE 102017 112 997 A1 or DE 10 2019 135 544 A1, the contents of which are fully incorporated by reference. Figure 7 shows the orthosis from Figure 6 for a left leg in its worn state. The foot section is arranged inside a shoe, which provides additional stability. The orthosis in Figure 7 is equipped with a friction joint 42.

[0037] Reference numeral list

[0038] 2 rigid area

[0039] 4 Longitudinal proportion

[0040] 6. Scope share

[0041] 8 flexible area

[0042] 10 strap

[0043] 12 anchor elements

[0044] 14 Deflection eyelet

[0045] 16 End

[0046] 18 proximal-distal direction

[0047] 20 connecting line

[0048] 22 layers of foil

[0049] 24 first connection area

[0050] 26 first part

[0051] 28 second part

[0052] 30 joint

[0053] 32 second connection area

[0054] 34 second bowl

[0055] 36 rail

[0056] 38 Ankle joint

[0057] 40 foot section

[0058] 42 driven joint

Claims

( G . in treal kmct uma ipr Lo pienr tsy Ottobock SE & Co. KGaA Lawyer's File: Max-Näder-Straße 15 0108-2056 PCT-1 37115 Duderstadt Germany Date: September 18, 2025 Patent claims 1. Orthosis for enclosing an extremity extending in a proximal-distal direction and having a circumference, wherein the orthosis - a rigid (2) area and - has a flexible area (8), wherein the rigid area (2) has a longitudinal portion (4) extending in a proximal-distal direction, to which a circumferential portion (6) is arranged extending in the circumferential direction, wherein the longitudinal portion (4) is connected to the circumferential portion (6) in such a way that the circumferential portion (6) lies dorsally against the extremity when the orthosis is applied, wherein the flexible area (8) connects circumferentially to the longitudinal portion (4) and the circumferential portion (6) of the rigid area (2).

2. Orthosis according to claim 1, characterized in that the longitudinal portion (4) is arranged laterally on the extremity when the orthosis is applied.

3. Orthosis according to claim 1 or 2, characterized in that an end of the circumferential portion (6) facing away from the longitudinal portion (4) is located closer to the medial side of the extremity than to the lateral side of the extremity, or is located equally close to the medial side and to the lateral side of the extremity when the orthosis is applied.

4. Orthosis according to one of the preceding claims, characterized in that the circumferential portion (6) is arranged in the distal region of the longitudinal portion (4), preferably at its distal end.

5. Orthosis according to one of the preceding claims, characterized in that the rigid area (2) and the flexible area (8) are formed in one piece.

6. Orthosis according to one of the preceding claims, characterized in that an end of the flexible area (8) facing away from the rigid area (2) is arranged between the rigid area (2) and the extremity when the orthosis is applied.

7. Orthosis according to one of the preceding claims, characterized in that the orthosis has at least one strap (10) which connects the rigid area (2) with the flexible area (8) and preferably runs frontally along the extremity when the orthosis is applied.

8. Orthosis according to claim 7, characterized in that the flexible area (8) has a rigid anchor element (12) on which the at least one strap (10) is arranged.

9. Orthosis according to claim 8, characterized in that one end of the at least one strap (10) is fixed to the anchor element (12) or the anchor element (12) has at least one deflection eyelet (14) through which the at least one strap (10) is guided.

10. Orthosis according to claim 7 or 8, characterized in that the anchor element (12) is arranged medially on the extremity when the orthosis is applied.

11. Orthosis according to one of the preceding claims, characterized in that the flexible area (8) has a greater extent in the proximal-distal direction at its end facing away from the rigid area (2) than at its end facing the rigid area (2).

12. Orthosis according to one of the preceding claims, characterized in that the flexible area (8) has an extension in the proximal-distal direction at its end facing away from the rigid area (2) which corresponds to the extension of the rigid area (2) in the proximal-distal direction.

13. Orthosis according to one of the preceding claims, characterized in that a connecting line (20) between the flexible area (8) and the rigid area (2) is at least partially, preferably completely, covered by at least one layer of film (22).

14. Orthosis according to claim 13, characterized in that the film layer (22) is connected to both the flexible area (8) and the rigid area (2), preferably by a material bond, and particularly preferably formed in one piece.

15. Orthosis according to claim 13 or 14, characterized in that at least one layer of film (22) is located on the side facing the extremity and / or the side facing away from the extremity.

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