Orthosis for placement on a human hand

Abstract

The invention relates to an orthosis (1) for wearing on a hand (2) of a person for at least limiting the movement of the carpometacarpal joint (CMCj) of the thumb, preferably also limiting the movement of the metacarpophalangeal joint (MCPj) of the thumb (2-1), the orthosis (1) comprising a metacarpal portion (3) extending across the metacarpal bones of the fingers 2 to 5 and a thumb portion (4) in a curved or ring shape fitting around the thumb (2-1), preferably around the proximal phalanx (6) of the thumb (2-1). The thumb portion (4) is connected to the metacarpal portion (3) via a thumb metacarpal portion (7) extending along and / or around the thumb metacarpal (8) when the orthosis (1) is worn on the hand (2).

Description

TECHNICAL FIELD

[0001] The present invention relates to an orthosis for wearing on a human hand for limiting at least the movement of the carpometacarpal joint (also called CMC1 joint) of the thumb and preferably also the movement of the metacarpophalangeal joint (MCP1 joint) of the thumb, the orthosis comprising a metacarpal part extending across the metacarpal bones of fingers 2 to 5 when the orthosis is worn on the hand, and a thumb part in a curved or ring shape fitting around the thumb, preferably around the proximal phalanx of the thumb, thus preferably leaving the distal phalanx of the thumb untethered. BACKGROUND

[0002] US 2019 / 053931 relates to an orthosis for fastening to a human hand for immobilizing the carpometacarpal joint and the metacarpophalangeal joint of the thumb of the hand, the orthosis having a rigid body which can be of a multi-piece design or a single-piece design. The rigidity of the body enables the body to be used for supporting, stabilizing and immobilizing the hand and to provide dimensional stability so that the body can be placed in a defined shape in a simple manner on the hand.

[0003] The WE CMC1 / MP1 stabilization splint is also known as a silver splint, which is made of standard pure silver and holds CMC1 and MCP1 in a fixed position. The splint is applied in the case of arthritis. The splint has a metacarpal part and a thumb ring which is welded directly to the metacarpal part.

[0004] Certain conditions and injuries require immobilization of the carpometacarpal (CMC) joint and the metacarpophalangeal (MCP) joint. One example of pathology is arthritis, which affects the cartilage and joint capsule of these joints in two of the most common forms, namely degenerative arthritis (osteoarthritis) and rheumatoid arthritis. Degeneration of the joint leads to pain and stiffness. Over the long term, the joint deforms, affecting the corresponding muscles and bones. This leads to a reduction in hand function, thus limiting people's daily lives.

[0005] Examples of injuries to the CMC1 joint and / or the MCP1 joint are repetitive strain injury (RSI) and skier thumb. RSI is caused by repetitive movements in daily routines, overuse of certain muscles and tendons can cause these muscles and tendons to become irritated and inflamed. Skier thumb refers to a sprain or even a tear of the ulnar collateral ligament (UCL), caused by the MCP1 joint being stretched too far, for example by falling on a ski pole. Although the name indicates skiing, skier thumb is often also caused by other sports, such as volleyball or basketball. In order to heal a sprained or partially torn tendon, stabilization of the thumb is of great importance. SUMMARY

[0006] It is an object of the present invention to provide an improved orthosis.

[0007] To this end, the orthosis according to the invention is characterized in that the thumb portion is connected to the metacarpal portion via a thumb metacarpal portion, which extends along and / or around the thumb metacarpal bone when the orthosis is worn on the hand.

[0008] The thumb metacarpal portion according to the invention provides for a supported movement of the thumb, preferably in the movement directions known as adduction, abduction, flexion and / or extension, which limits the movement sufficiently to prevent pain or injury, and which at the same time provides support for the trapezium. Furthermore, in use, the wearer can still move his / her thumb by exerting a force in a certain direction and elastically deforming the orthosis. When the wearer stops exerting the force, the elasticity will return the splint to its equilibrium position and, in doing so, guide the thumb to the natural position of the thumb. The force generated by the movement of the thumb is transmitted via the thumb metacarpal portion to the metacarpal portion and distributed over the palmar side of the hand and / or the dorsal side of the hand.

[0009] Although the orthosis can be articulated, for example by means of one or more flexible or rotational joints and, for example, spring-loaded joints, connecting the thumb portion to the thumb metacarpal portion and / or connecting the thumb metacarpal portion to the metacarpal portion, the thumb metacarpal portion is preferably elastic. The elasticity can be realized, for example, by the choice of material, the thickness of the material and / or by the construction.

[0010] In embodiments, the thumb metacarpal portion is cantilevered from the metacarpal portion. Preferably the thumb metacarpal portion is connected to the metacarpal portion at its proximal end or base, and there is no other connection such as solder, weld or bridge between the two. In another embodiment, the thumb metacarpal portion extends spirally between the metacarpal portion and the thumb portion, preferably for at least 180° or more, i.e. at least half a turn. These embodiments provide effective methods which on the one hand achieve a certain degree of freedom of movement, while on the other hand maintaining sufficient support and providing elasticity to return the splint to its equilibrium position.

[0011] In embodiments, the counter force on the thumb portion is substantially proportional to the movement of the thumb. The relationship between the counter force and the movement of the thumb is dependent on several aspects and is therefore complex and difficult to quantify precisely. In embodiments, the relationship between the counter force on the thumb portion and the movement of the thumb is linear ± 40% or linear ± 20%. In other words, although the relationship itself is not linear, it is generally a curve which extends within ± 40% of a linear relationship.

[0012] In embodiments, the movement of the thumb in at least one of the movement directions, referred to as adduction, abduction, flexion and extension, is limited to a range of 5% to 95% of the total range of movement of the wearer, preferably to a range of 15% to 85%, preferably to a range of 30% to 70%, preferably to a range of 40% to 60%.

[0013] In examples, for patients requiring more support, e.g. if more movement restriction is required and / or if the user's hand strength is above average, a higher stiffness should be chosen. For users requiring less support, e.g. in case of less arthritic and / or if the user's hand strength is below average, a lower stiffness should be chosen. By achieving or more accurately approaching the minimum support required for therapy, compliance is generally increased, as the patient is less restricted and more comfortable in wearing the orthosis. Higher compliance in turn increases the efficiency of the therapy and helps to avoid necessary surgery.

[0014] In embodiments, the thumb metacarpal portion extends on the volar side of the metacarpophalangeal (MCP) joint (across the volar side of the metacarpophalangeal (MCP) joint) when the orthosis is worn on the hand.

[0015] In another embodiment, the connection or transition between the thumb metacarpal portion and the metacarpal portion is located on the dorsal side of the hand, preferably close to the MCP joint of the index finger, i.e. below the MCP joint of the index finger and following the line of the way between the CMC joint of the thumb and the MCP joint of the thumb to wrap around to the volar side of the hand at the MCP joint.

[0016] In another embodiment, when the orthosis is worn on the hand, the metacarpal portion extends on the palmar side of the hand, preferably leaving most of the dorsal side of the hand untethered. In a refinement, the metacarpal portion extends proximal to the MCP joints of fingers 2-5.

[0017] In an embodiment, the thumb portion comprises a loop which, when the orthosis is worn on the hand, encircles the thumb, preferably at a location between the MCP thumb joint and the IP thumb joint. The small opening allows the circumference of the thumb loop to flex, facilitating the placement and removal of the orthosis.

[0018] In an embodiment, to provide, e.g., a smooth curve and / or a smooth gradient in support, stiffness, and / or elasticity along the length of the orthosis, the orthosis is made in one piece, such as a plastically deformed plate, band, or rod, or in a continuous element, e.g., a molded or 3D-printed continuous element. The orthosis can be made of a single material and / or a homogeneous material, or of a composite material, e.g., of a fiber-reinforced material, and / or include portions of softer material, such as foam or silicone, and / or of different colors.

[0019] For example, in an embodiment, the width and / or thickness of the orthosis varies along its length. The width is typically largest at the ulnar and radial tabs, as this provides the most comfortable pressure distribution. The upper thumb loop is the narrowest part, as this part of the hand area is the smallest, and in order to avoid flexion and extension of the IP joint or to cause interference with performing daily tasks.

[0020] In an embodiment, the width is in the range of 3-50 mm, preferably 4-20 mm, and / or the thickness is in the range of 1-15 mm, preferably 2-12 mm.

[0021] As mentioned above, the elasticity, and in turn the counterforce on the thumb portion that depends on the flexion of the thumb, can be achieved, e.g., by the choice of material, the thickness of the material, and / or by the construction (shape of the construction). The elasticity is typically different for each direction (anisotropic). Suitable materials include thermoplastic materials, e.g., polymers such as cellulose acetate, polylactic acid (PLA), and polyamide (Nylon), and metals, in particular metals with a high yield strength, such as titanium and Monel.

[0022] For the sake of completeness, please note the following prior art.

[0023] WO 2014 / 070621 (EP 2914218) relates to a spiral brace "having an inner surface corresponding to a digital representation of an injured limb. The spiral brace can be wrapped around a length of the limb in a spiral manner. The body of the spiral brace can be a single piece construction that is fenestrated to provide air flow to the injured limb. The invention will now be explained in more detail with reference to the drawings, which show preferred embodiments of the invention. Figures 12 to 15 show a spiral brace that restricts thumb movement".

[0024] US 4854310 relates to a splint for immobilizing a portion of a limb, the splint having an elongated rigid sheet, a rigid collar and at least one retaining strap. Figure 1 and Figure 2 The splint 10 of the embodiment shown also has a rigid collar 17 in the shape of an elongated letter "C" that extends circumferentially around more than half of the hand 18 … Optionally, a handle 19 connected to the collar 17 extends in the direction of the thumb 14 to a ring 110. The ring 110 is made of stainless steel band and is connected to the handle 19. The ring 110 is bent to almost a full circle to fit around the thumb. The combination of the handle 19 and the ring 110 prevents lateral movement of the thumb 14 relative to the collar 17.

[0025] WO 2014 / 148906 relates to "a finger protection device for preventing injuries to the fingers during activities in which the ligaments of the hand are subjected to large stresses and tensions. The finger protection device comprises a hand support element for accommodating at least the wrist region of the hand, and at least one finger support structure comprising a finger tip cover for accommodating the top of the finger, and a flexible connecting element extending between the hand support element and the finger tip cover, the connecting element having sufficient rigidity to transmit an axial first force exerted on the finger tip cover to the hand support element. Furthermore, the invention relates to a finger protection device for preventing injuries to the thumb, i.e. a thumb protection device".

[0026] US 2013 / 0197411 relates to a "Volar thumb and thumb saddle joint splint comprising a first splint part for accommodating the thumb and means for fixing the first splint part to the hand". The object is "to make a volar thumb and thumb saddle joint splint which allows a specific and complete immobilization of the thumb saddle joint, …".

[0027] DE 8515915 relates to a splint for immobilizing the thumb saddle joint.

[0028] Unpublished European patent application EP 3620136 relates to a wrist orthosis for supporting a patient's wrist, comprising a metal wire frame for engaging with the patient's forearm, wrist, and hand, the metal wire frame including a radial wire section configured to extend distally along the radial side of the forearm, wrist, and towards the hand.

[0029] Within the framework of this invention, the terms "connected to" and "connected" related to the thumb, metacarpal portion, and thumb metacarpal portion include a continuous transition, for example, when the orthosis is made from a single piece of one or more materials. The term "orthosis" includes braces and splints. The adjective "spiral" has its usual meaning, i.e., having a three-dimensional shape, such as a three-dimensional shape formed by metal wire uniformly wound around a cylinder or cone (as in a spiral bottle opener or spiral staircase). Attached Figure Description

[0030] Figures 1 to 3 This is a perspective view of a first embodiment of an orthosis according to the present invention, which is worn on the hand and has a metacarpal portion extending on the palmar side of the hand.

[0031] Figures 4 to 7 This is a perspective view of the first embodiment of the orthosis after it has been removed from the hand.

[0032] Figure 8 It is a diagram showing different degrees of elasticity.

[0033] Figure 9 This is a perspective view of a second embodiment of an orthosis according to the invention, which is worn on the hand and has a metacarpal portion extending on the dorsal side of the hand. Detailed Implementation

[0034] Figures 1 to 3 A first orthotic device 1 according to the invention is shown, which is worn on the hand 2 to restrict the movement of the carpal joint CMCj and metacarpophalangeal joint MCPj of the thumb 2-1. Figures 4 to 7 The same orthosis after removal from hand 2 is shown. Orthosis 1 includes a metacarpal portion 3 and a thumb portion 4. When the orthosis is worn on the hand, the metacarpal portion 3 extends across the metacarpal bones of fingers 2 to 5, namely the index finger (finger 2; reference numeral 2-2 in the figure), the middle finger (finger 3; reference numeral 2-3), the ring finger (finger 4; reference numeral 2-4), and the little finger (finger 5; reference numeral 2-5). The thumb portion 4 is curved and conforms to the proximal phalanx 6 surrounding the thumb 2-1, leaving the distal phalanx of the thumb unrestrained.

[0035] The orthosis is a single piece of thermoplastic material, such as cellulose acetate or polyamide, which is manufactured by moulding or additive manufacturing, followed by polishing.

[0036] The thumb portion 4 is connected to the metacarpal portion 3 via a thumb metacarpal portion 7, which extends along or around the thumb metacarpal (MCP1) 8 when the orthosis 1 is worn on the hand 2.

[0037] In the present example, the metacarpal portion 3 extends on the palmar side of the hand, following the shape of the palm, and "hooks around" the ulnar and radial sides of the hand. The metacarpal portion is open on one side, in the present example on the dorsal side of the hand, to facilitate placing it on the hand. Once in place, the metacarpal portion provides a base for the support-elastic thumb metacarpal and thumb portions.

[0038] The thumb portion 4 consists of an open loop, which, when the orthosis is worn on the hand, encircles the thumb between the MCP thumb joint and the IP thumb joint. The small opening allows the circumferential flexure of this thumb loop, facilitating the placement and removal of the orthosis.

[0039] As is most clearly shown in Figure 1 and Figure 6 , the thumb metacarpal portion 7 is cantilevered from the metacarpal portion 3 and extends in a spiral between the metacarpal portion 3 and the thumb portion 4, extending almost a full turn. In this example, the thumb metacarpal portion 7 transitions into the metacarpal portion 3 at its proximal end, and there is no other connection between the two portions 7, 3. Since the orthosis is manufactured as a single piece, the connection between these two portions is not discrete, but a continuous transition. In Figure 6 this transition is indicated roughly by means of a line T1. The same is true for the transition between the thumb portion 4 and the thumb metacarpal portion 7, which is indicated by a second line T2 in Figure 6 .

[0040] Figure 8 is a graph showing the counterforce on the thumb portion as a function of the flexion of the thumb, in which curve A represents a material and / or structure with a relatively high stiffness in the flexion direction, and curve B represents a material and / or structure with a relatively low stiffness in the flexion direction.

[0041] The orthosis according to the invention provides for a movement of the supported thumb while reducing the risk of pain or injury. The wearer can still move his / her thumb by exerting a force in a certain direction and elastically deforming the orthosis. When the wearer stops exerting the force, the elasticity will return the splint to its equilibrium position and, in doing so, guide the thumb to the natural position of the thumb. The orthosis can be compact, unobtrusive, not attention- drawing, and feel warm when materials with low thermal conductivity are used. The construction in the above example does not require closure.

[0042] In an example, the patient has grade 2 (Kellgren-Lawrence grading) degenerative arthritis at the CMC1 joint and the MCP1 joint of his right hand. The wrist and other finger joints are free of arthritis. The patient is a male, 36 years old, and works on a farm, which means that a large part of his work is intensive physical labor. Without limitations in the range of motion (ROM), he is able to exert a pinch force of 12 kg with his right thumb and, during physical labor, experiences a pain level of 8 / 10 according to the Numerical Rating Scale (NRS). To reasonably support the thumb of this man, the orthosis needs to limit the CMC1 joint and the MCP1 joint. With a force of 7.5 kg, the total ROM needs to be reduced by 80%. This ROM limitation means that, with the orthosis worn, the total allowed flexion ROM of the CMC1 joint is 1 cm when a force of 7.5 kg is exerted.

[0043] The invention is not limited to the above-described examples, which can be varied in many ways within the scope of the claims. For example, the metacarpal portion can be closed or open on the volar side of the hand instead of open on the dorsal side of the hand, as shown in Figure 9 the figures.

Claims

1. An orthosis (1) for wearing on a human hand (2) for at least restricting the movement of the carpal metacarpophalangeal joint (CMCj) of the thumb, said orthosis (1) comprising a metacarpal portion (3) and a thumb portion (4), wherein when said orthosis (1) is worn on the hand, the metacarpal portion (3) extends across the metacarpals of fingers 2 to 5; the thumb portion (4) is curved or annular and conforms to the proximal phalanges (6) surrounding the thumb (2-1), characterized in that, The thumb portion (4) is connected to the metacarpal portion (3) via an elastic thumb metacarpal portion (7). When the orthosis (1) is worn on the hand (2), the thumb metacarpal portion (7) extends along and / or around the thumb metacarpal (8), allowing the wearer to still move their thumb by applying force in a specific direction and causing the orthosis (1) to elastically deform, and when the wearer stops applying force, the elasticity causes the orthosis (1) to return to its equilibrium position.

2. The orthotics (1) according to claim 1, wherein, The thumb metacarpal portion (7) is cantilevered from the metacarpal portion (3).

3. The orthotics (1) according to claim 1, wherein, The thumb metacarpal portion (7) extends spirally between the metacarpal portion (3) and the thumb portion (4), and extends at least 180°.

4. The orthotic device (1) according to any one of claims 1 to 3, wherein, The reaction force on the thumb portion (4) is proportional to the movement of the thumb (2-1).

5. The orthotic device (1) according to any one of claims 1 to 3, wherein, The movement of the thumb (2-1) is restricted to 5% to 95% of the wearer's total range of motion.

6. The orthotic device (1) according to any one of claims 1 to 3, wherein, When the orthosis (1) is worn on the hand (2), the thumb metacarpal portion (7) extends on the palmar side of the metacarpophalangeal joint (MCPj).

7. The orthotic device (1) according to any one of claims 1 to 3, wherein, The connection between the thumb metacarpal portion (7) and the metacarpal portion (3) is located on the dorsal side of the hand (2).

8. The orthotic device (1) according to any one of claims 1 to 3, wherein, The thumb portion (4) includes an open ring.

9. The orthopedic device (1) according to any one of claims 1 to 3, wherein, When the orthosis (1) is worn on the hand, the metacarpal portion (3) extends on the palmar side of the hand (2).

10. The orthotics (1) according to claim 9, wherein, The metacarpal portion (3) extends close to the metacarpophalangeal joints of fingers 2 to 5 (2-2 to 2-5).

11. The orthopedic device (1) according to any one of claims 1 to 3, wherein, The orthotic device (1) is made of single or continuous elements, the single element including plastically deformable plates, strips or rods, and the continuous elements including molded or 3D printed elements.

12. The orthotic device (1) according to any one of claims 1 to 3, wherein the orthotic device (1) is made of a single material or a composite material.

13. The orthopedic device (1) according to any one of claims 1 to 3, wherein, The width and / or thickness of the orthosis (1) varies along the length of the orthosis.

14. The orthopedic device (1) according to claim 13, wherein, The width is in the range of 3mm to 50mm.

15. The orthopedic device (1) according to claim 13, wherein, The thickness is in the range of 1 mm to 15 mm.

16. The orthotics (1) according to claim 12, wherein, The single material is a homogeneous material.

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