ES2925548A1 - ORTHOPEDIC DEVICE FOR THE TREATMENT OR PREVENTION OF CARPAL TUNNEL SYNDROME (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Orthopedic device for the treatment or prevention of carpal tunnel syndrome. The present invention relates to a three-dimensional orthopedic device for the treatment or prevention of carpal tunnel syndrome and related conditions. This device is based on a semi-rigid splint in the form of a bracelet, non-slip, breathable, non-stick and bactericidal, which achieves decompression of the median nerve by modifying the morphology of the carpal tunnel by applying local forces on the carpal bones, without affecting the functional capacity of the user's upper extremity and guaranteeing maximum comfort during the normal development of their daily activity. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

ORTHOPEDIC DEVICE FOR THE TREATMENT OR PREVENTION OF CARPAL TUNNEL SYNDROME

FIELD OF THE INVENTION

The present invention falls within the field of orthopedic devices. More specifically, the invention refers to a semi-rigid splint in the form of a bracelet used for the treatment or prevention of carpal tunnel syndrome and related conditions by modifying the morphology of the carpal tunnel.

BACKGROUND OF THE INVENTION

The hand is made up of different bones, muscles, and ligaments that allow for a large number of movements. With respect to the bones of the hand, humans have a total of twenty-seven, of which eight constitute the wrist. These eight bones, known as the carpal bones, are arranged in two rows, the bones in each row being tightly knit. The proximal row is composed of the scaphoid, lunate, triquetrum, and pisiform bones, while the distal row comprises the trapezium, trapezoid, capitate, and hamate bones. The scaphoid, lunate, and part of the triquetrum articulate with the distal end of the radius to form the radiocarpal joint. The distal surface of the proximal row forms a deep concave notch into which the bones of the distal row fit, forming the midcarpal joint.

The anatomical space formed by the carpal bones and the annular or transverse carpal ligament is called the carpal tunnel. Through the interior of this tunnel pass: the tendons of the superficial and deep flexor muscles of the fingers, the tendon of the long flexor muscle of the thumb, and the median nerve.

Carpal tunnel syndrome is usually caused by increased pressure on the median nerve. When the median nerve is compressed, it usually causes pain, numbness, tingling, and/or weakness in the hand and forearm. The morphology of the hand and wrist, as well as possible repetitive movements of the hand, can contribute to the development of this syndrome.

Treatment of carpal tunnel syndrome aims to reduce pressure on the median nerve and prevent irreversible nerve damage over time. Non-pharmacological treatments for mild or moderate cases of this syndrome include the use of orthopedic devices that maintain the position of the wrist, cause stretching of the transverse carpal ligament, or modify the shape of the carpal tunnel.

Orthopedic devices that maintain wrist position are the most commonly used for carpal tunnel treatment. They are passive splints that only maintain the position of the wrist joint. They are usually placed mainly on the ventral side of the forearm, wrist and hand. They are usually made of rigid material (such as, for example, the devices disclosed in patents US6106492A, US5769804A, US6383157B1), semi-rigid (see, for example, US20040176714A1, US5766141A, US7081102B1) or flexible (see, for example, US4883073A, US50 US1B6515 , US6213969B1). These devices do not cause a modification of the carpal tunnel space and neither do they modify the compressive forces that are produced on the median nerve. In addition, many of them cause unwanted anterior compression of the carpal tunnel.

As for orthopedic devices that stretch the transverse carpal ligament, these cause a temporary aggravation of carpal tunnel syndrome due to a momentary increase in pressure within said tunnel and, therefore, on the median nerve. However, because the carpal tunnel also widens, a reduction in pressure on the median nerve is eventually achieved and, consequently, a reduction or prevention of the symptoms of carpal tunnel syndrome. Within this group is the device protected by patent US5468220A, of a rigid nature and in the shape of a bracelet.

The third type of devices used for the treatment of carpal tunnel syndrome are semi-rigid or soft splints that modify the shape of the carpal tunnel, increasing its space. These devices mainly perform the corrective forces on the bones of the forearm; that is, without a direct effect on the carpal bones (see, for example, US4966137A, US5385537A, US6120472A, US5413553A), affecting the functional capacity of the upper extremity of the user and, consequently, the normal development of their daily activity . In addition, they do not prevent compression on the ventral or anterior part of the carpal tunnel, they do not control the position of the wrist and/or do not conform to the carpal bones of the distal row (see, for example, US5478306A, US5921949A).

The present invention proposes a solution to the aforementioned limitations, by means of a novel three-dimensional orthopedic device that has improved efficacy compared to known devices.

BRIEF DESCRIPTION OF THE INVENTION

In light of the problems of the state of the art exposed in the previous section, the object of the present invention relates to a three-dimensional orthopedic device for the treatment of carpal tunnel syndrome and related conditions by increasing circularity and the antero-posterior diameter of the carpal tunnel, without causing compression of said anatomical space and without affecting the functional capacity of the user's upper extremity.

In the scope of interpretation of the present invention, "ventral" means the front part of the hand, the palm; "dorsal" means the part opposite the ventral part; by "proximal", to the part attached to the wrist; by "distal", to the part opposite to the proximal and, by "medial", to the central axis of the hand that corresponds to the third finger. Likewise, it will be understood by "internal carpal bones", those that are found in the lateral area of the hand corresponding to the little finger or ulnar edge; that is, pisiform in the proximal row, and hamate in the distal; by "external carpal bones", those that are found in the lateral area corresponding to the thumb or radial border; that is, scaphoid in the proximal row, and trapezium in the distal; and, by "central carpal bones", to those that are lodged between the internal and external bones; that is, pyramidal and lunate in the proximal row, and trapezoid and large in the distal.

Likewise, in the present invention, "semi-rigid" is understood as that material that has a degree of elasticity such that it is capable of substantially recovering its shape when the action of the force that deformed it ceases. Advantageously, and as will be described in greater detail In the following sections, the orthopedic device of the invention has a bracelet-shaped or substantially C-shaped structure, which, thanks to its semi-rigid nature, can be partially opened for placement on the patient's wrist, and later closed by itself. on the doll, also partially, applying a corrective force on the patient's carpal bones of intermittent intensity regulated by the movement of the wrist.

Thus, the device of the invention preferably comprises:

- a central body configured to be placed on the dorsal region of the wrist and, at least, the distal third of the forearm; Y

- two arms located in opposite positions of the central body, configured to surround the wrist and at least the distal third of the forearm, leaving a ventral opening between them.

Advantageously, the device is characterized in that the internal part of the central body and the arms is non-slip, and the external part is semi-rigid, so that, when the device is placed on the wrist of a user through the ventral opening, the The internal part is in contact with said wrist, and the external part exerts a corrective force on the internal and external bones of the carpus from the dorsal region towards the ventral-medial region of the wrist of intermittent intensity regulated by the movement of the wrist. In this way, a ventral displacement and approach of said bones is achieved, and a dorsal displacement of the central bones of the carpus. These displacements cause an increase in both the circularity and cross-sectional area of the carpal tunnel.

In a preferred embodiment of the invention, the external part of the device comprises a monolayer of a semi-rigid thermoplastic polymer, semi-rigid carbon fiber, fiberglass or any other material with similar mechanical properties. These materials are suitable for their lightness, high mechanical resistance, limited elasticity and ease of manufacture.

In a preferred embodiment of the invention, the internal part of the device comprises a non-stick, bactericidal material that favors the perspiration of the skin of the wrist, to guarantee the maximum support and stability of the device to the user's wrist, as well as the maximum comfort and hygiene during the normal development of their daily activity.

In a preferred embodiment of the invention, the internal part of the device comprises a single layer of polyurethane foam, due to its flexibility, resistance to water and fat, and its shock-absorbing capacity against impacts, a viscoelastic pad, a breathable terry cloth, velor fabric or any other material with similar mechanical properties.

In a preferred embodiment of the invention, the internal and external parts of the device are microperforated to promote perspiration.

In a preferred embodiment of the invention, the ventral opening corresponds to the ventral region of the wrist overlying the transverse carpal ligament and has a width between 1 and 2 cm before the placement of the splint on the wrist. This allows the modification of the dimensions of the carpal tunnel avoiding direct compression of it and, therefore, of the median nerve.

In a preferred embodiment of the invention, the surface of the bracelet formed by the central body and the arms has a shape adapted to the morphology of the wrist and at least one third of the distal part of the forearm, with a maximum length of 4 cm. Together with the non-slip nature of the internal part of the splint, this allows greater stability of the device on the user's wrist and, consequently, less frequent position adjustments by a professional.

In a preferred embodiment of the invention, the orthopedic device may additionally comprise a secondary reinforcing element to further intensify the corrective effect on the carpal tunnel, configured to be placed on the central body and the two arms of the bracelet. Said element is substantially C-shaped, with a ventral opening to avoid direct compression of the anterior part of the carpal tunnel. Optionally, the material of said secondary reinforcement element comprises a semi-rigid thermoplastic polymer, semi-rigid carbon fiber, fiberglass or any other material with similar mechanical properties, due to the aforementioned advantages.

DESCRIPTION OF THE FIGURES

Figs. 1a, 1b and 1c show the perspective views of the ventral, distal and proximal areas of the device of the invention according to a preferred embodiment thereof, respectively.

Figs. 2a, 2b and 2c show the top, right side and bottom views of the device of the invention placed on the left hand of a user, respectively.

Fig. 3a represents a diagram of the forces applied by the device of the invention on the carpal bones and Fig. 3b of the displacements caused in them by the action of these forces.

Fig. 4 shows, on a cross-sectional view of the wrist, the effect caused by the device of the invention on the position of the carpal bones and the morphology of the carpal tunnel and the median nerve. The dashed thin line represents the position of the carpal bones before the device is placed and the continuous thin line, with the device in place. The thick dashed line represents the perimeter of the carpal tunnel and the nerve before the device is placed, and the solid thick line, with the device in place.

Fig. 5a shows a front view of the reinforcing element and Figs. 5b and 5c, the right side and bottom views of the device of the invention placed on the left hand of a user when it includes said reinforcement element, respectively.

NUMERICAL REFERENCES USED IN THE FIGURES

In order to help a better understanding of the technical characteristics of the invention, the aforementioned figures are accompanied by a series of numerical references where, by way of illustration and not limitation, the following is represented:

DETAILED DESCRIPTION OF THE INVENTION

As described in previous sections, the orthopedic device object of the present invention preferably consists of a semi-rigid splint in the form of a bracelet for the treatment of carpal tunnel syndrome and related conditions by modifying the morphology of the carpal tunnel. carpus (Figs.1a-1c). Said device mainly comprises a central body (1) configured to be placed on the dorsal region of the wrist and, at least, the distal third of the forearm, and two arms (2, 3) located in opposite positions of the body (1). ) central, configured to surround the wrist and, at least, the distal third of the forearm (Fig. 2a and 2b), leaving a ventral opening (4) between them to avoid direct pressure on the anterior part of the wrist (Fig. 2 C). Preferably, said ventral opening (4) coincides, when placed on the user's wrist, with the ventral region overlying the transverse carpal ligament, its width being preferably between 1 and 2 cm when the device is not placed on the wrist (Fig. 1a). Regarding its size, the device preferably has a longitudinal dimension of approximately 40 mm, and a transversal dimension of 65 mm.

Regarding its structure, the device of the invention is made up of an internal anti-slip part (5) and an external semi-rigid part (6). Once placed on the user's wrist by widening the ventral opening, the brace remains in contact with the wrist and the distal third of the forearm through the inner part (5), while the outer part (6) exerts a corrective force on the internal (7) and external (8) bones of the carpus from the dorsal region to the ventral-medial region of the wrist (Fig.3a) of intermittent intensity regulated by the movement of the wrist.

These forces cause at least three different displacements of the carpal bones (Fig. 3b): a ventral displacement and an approach of the internal (7) and external (8) bones; that is, hamate and trapezius in the distal row, and pisiform and scaphoid in the proximal; and a dorsal displacement of the central bones (9); that is, large and trapezoid in the distal row, and lunate and pyramidal in the proximal.

These displacements of the carpal bones, exemplified in Fig. 4 by the positions of these bones before placing the splint (thin dashed line) and with the device in place (thin solid line), translate into a greater circularity and area of cross section of the carpal tunnel (compare thick dashed and solid lines in Fig. 4). In turn, this change in the morphology of the carpal tunnel implies a reduction in the pressure exerted on the median nerve (10) and, consequently, an increase in both the cross-sectional area and the circularity of said nerve (10). ) (see dashed and continuous gray lines in Fig.4).

The device of the invention makes it possible to keep the wrist in a slightly flexed position. By leaving the movements of the forearm and fingers free, the device allows maintaining adequate functionality of the upper extremity. It can be used both day and night.

In a preferred embodiment of the invention, the external part (6) of the device comprises a monolayer of a semi-rigid thermoplastic polymer, semi-rigid carbon fiber, fiberglass or any other material with similar mechanical properties. These materials are suitable for their lightness, high mechanical resistance, limited flexibility and ease of manufacture.

In a preferred embodiment of the invention, the internal part (5) of the device comprises a non-stick, bactericidal material that favors the perspiration of the skin of the wrist, to guarantee maximum support and stability of the device to the user's wrist, as well as the maximum comfort and hygiene during the normal development of the user's activity.

In a preferred embodiment of the invention, the internal part (5) of the device comprises a single layer of polyurethane foam, due to its flexibility, resistance to water and grease, and its shock-absorbing capacity against impacts, a pad viscoelastic, a breathable terry cloth, velor fabric or any other material with similar mechanical properties.

In a preferred embodiment of the invention, the internal part (5) and the external part (6) of the device are micro-perforated to promote perspiration.

In a preferred embodiment of the invention, the internal part (5) and the external part (6) of the device have a thickness between 2 and 4 mm.

In a preferred embodiment of the invention, the surface of the bracelet formed by the central body (1) and the arms (2, 3) has a shape adapted to the morphology of the wrist and, at least, a third of the distal part of the forearm, with a maximum length of 4 cm. Together with the non-slip nature of the internal part of the splint, this allows greater stability of the device on the user's wrist and, consequently, less frequent position adjustments by a professional.

In a preferred embodiment of the invention, the orthopedic device may additionally comprise a secondary reinforcement element (11) (Fig. 5a) to further intensify the corrective effect on the carpal tunnel, configured for placement on the body (1) center of the bracelet and the two arms (2, 3) (Fig. 5b). Said secondary element (11) is substantially C-shaped, with a ventral opening to avoid direct compression of the anterior part of the carpal tunnel (Fig. 5c). Optionally, the material of said secondary reinforcement element (11) comprises a semi-rigid thermoplastic polymer, semi-rigid carbon fiber, fiberglass or any other material with similar mechanical properties, due to the aforementioned advantages.

Claims (10)

1. Orthopedic device for the treatment or prevention of carpal tunnel syndrome and its related conditions, having the shape of a bracelet, or substantially C, and comprising: - a central body (1) configured to be placed on the dorsal region of the wrist and, at least, the distal third of the forearm; Y - two arms (2, 3) located in opposite positions of the central body (1), configured to surround the wrist and at least the distal third of the forearm, leaving a ventral opening (4) between them, where said device is characterized in that the internal part (5) of the central body (1) and of the arms (2, 3) is non-slip, and the external part (6) is semi-rigid, so that, when the device is placed in a user's wrist through the ventral opening (4), the inner part (5) is in contact with said wrist, and the outer part is adapted to exert a corrective force on the internal (7) and external (7) bones. 8) of the carpus from the dorsal region to the ventral-medial region of the wrist with intermittent intensity regulated by the movement of the wrist. 2. Orthopedic device according to the preceding claim, wherein the external part (6) of said device comprises a monolayer of a semi-rigid thermoplastic polymer, semi-rigid carbon fiber or fiberglass. 3. Orthopedic device according to any of the preceding claims, wherein the internal part (5) of said device comprises a non-stick, bactericidal and breathable material. 4. Orthopedic device according to any of the preceding claims, wherein the internal part (5) of said device comprises a monolayer of polyurethane foam, a viscoelastic pad, a breathable terry cloth or velor fabric. 5. Orthopedic device according to any of the preceding claims, wherein the internal part (5) and the external part (6) of said device are microperforated. 6. Orthopedic device according to any of the preceding claims, wherein the internal part (5) and the external part (6) of said device have a thickness between 2 and 4 mm. 7. Orthopedic device according to any of the preceding claims, wherein the ventral opening (4) corresponds to the ventral region of the wrist overlying the transverse carpal ligament and has a width of between 1 and 2 cm when the device is not placed on the doll. 8. Orthopedic device according to any of the preceding claims, wherein the surface of the bracelet formed by the central body (1) and the arms (2, 3) has a shape adapted to the morphology of the wrist and, at least, a third of the distal part of the forearm, with a maximum length of 4 cm. 9. Orthopedic device according to any of the preceding claims, further comprising a secondary reinforcing element (11), configured to be placed on the central body (1) and the two arms (2, 3) of the bracelet and having a substantially rectangular shape. of C with a ventral opening. 10. Orthopedic device according to the preceding claim, wherein the material of the secondary reinforcing element (11) comprises a semi-rigid thermoplastic polymer, semi-rigid carbon fiber or fiberglass.