Orthosis for the prevention of clubfoot and pressure ulcers in bedridden patients

Abstract

Orthosis for the prevention of clubfoot and pressure ulcers in bedridden patients who spend long periods lying on their back, characterised by a removable rigid foot support consisting of three flat pieces joined together at right angles via connecting slots, a transverse stop with lateral brackets and two identical parallel arms in the shape of an elongated trapezium, which maintains the patient's foot in a correct anatomical position, promoting dorsiflexion and limiting plantar flexion, onto which a disposable, padded anti-bedsore foot protector is fitted, specifically designed and made from materials to ensure even weight distribution across the heel and malleoli, reducing the risk of pressure ulcers. It is a Class I medical device which, thanks to its design based on simple, detachable elements, offers significant benefits of use, such as quick and easy assembly, adaptability to any foot type, durability and easy maintenance.

Description

[0001] DESCRIPTION

[0002] Orthosis for preventing equinus foot and for decubitus injury in bedridden patients.

[0003] The object of the present invention is a new orthosis for the prevention of equinus foot and pressure ulcers in bedridden patients, with long stays in bed in a dorsal, supine position.

[0004] This orthosis is characterized by a detachable rigid foot support, made up of three flat pieces fitted at right angles by means of connecting slots, a transverse stop with lateral brackets and two equal parallel arms in the shape of an elongated trapezoid, onto which a disposable padded foot / heel anti-decubitus boot or protector of specific design and material is adapted.

[0005] It is a Class I, non-sterile medical device intended for Intensive Care Units (ICUs), or any other unit or service for patient care, to have an orthopedic device specifically designed for patients bedridden for prolonged periods, fulfilling the dual function of an anti-equinus and anti-decubitus orthosis, since: 1. The rigid support maintains the patient's foot in a correct anatomical position, promoting dorsiflexion and limiting plantarflexion, preventing equinus foot; and, 2. the innovative design of the padded boot ensures the uniform distribution of weight on the heel and malleoli, significantly reducing the risk of pressure injuries, preventing the formation of pressure ulcers.

[0006] Furthermore, thanks to its design based on simple and detachable elements, it is a product that offers important advantages for use in these Units, such as quick and easy assembly, adaptability to any type of foot, easy access for quick interventions, durability and easy maintenance of the support, or a padded boot that is washable and easy to disinfect, or replaceable at a low price, with the consequent savings in hospital costs.

[0007] TECHNICAL FIELD. -

[0008] The technical field in which the invention is framed, within the health sector, is that of orthopedic devices, bandages and dressings; more specifically, it is a combination of those relating to orthoses for the prevention of equinus foot and those relating to orthoses for the prevention of pressure ulcers, both aimed at bedridden patients.

[0009] STATE OF THE ART.

[0010] There is a growing demand in the healthcare market for preventing complications in immobilized patients, such as equinus foot, a foot deformity in which the foot is permanently in a plantar flexed position (pointing downwards), and more commonly, pressure ulcers, also known as bedsores or pressure sores, which are lesions of the skin and underlying tissue caused by prolonged pressure when the patient remains lying down. Currently, preventing these conditions in bedridden patients is a critical need in hospitals and ICUs, a need that is not being met simultaneously by a comprehensive solution like the one offered by the proposed system, which minimizes both the risk of the patient developing this foot deformity and the formation of bedsores or pressure sores in sensitive areas such as heels and ankles.

[0011] Most of the anti-equinus orthoses on the market are orthopedic devices and splints for correcting or treating the pathology, usually designed for everyday needs such as walking or sitting. This is reflected in the patented technology, as the existing patents in this field all relate to different orthoses of this type, such as utility model ES1027539-U (1994) “Improved orthopedic device for correcting equinus foot,” or the published patents ES2526266-A1 (2015) “Active plantar orthosis for equinus foot,” RU2722456-C1 (2020) and ES1297733-U (2023), on devices for treating equinus foot, or the international application WO2023075588-A1 (2023), for “Passive, gradual adjustment corrective device and progressive for the treatment of clubfoot.”However, no patent documents were found on anti-equinus orthoses specifically for bedridden patients with loss of muscle mass due to the treatment they are undergoing, of the type of foot support like that of the present invention.

[0012] On the other hand, regarding anti-decubitus orthoses, what is patented are various boot and heel protector solutions for preventing pressure ulcers on the feet that can be used in bed, but none correspond to a boot or heel protector on an easily removable support structure like the proposed system. Examples of patents that have expired include the published utility model applications ES1032692-U (1996) “Protective boot to prevent heel ulcers”, ES1089282-U (2013) “Heel protector for the prevention of pressure ulcers” or ES1223764-U (2019) “Heel protector”, and the European patent ES2715114-T3 (2019) “Integral protector for a limb of a living being”.

[0013] For the prevention of equinus foot in patients who spend long periods lying on their backs, only a few orthotic solutions from different orthopedic brands are known, which also usually incorporate pressure ulcer protectors. However, these devices are different from the invention, consisting of rigid foot and leg wraps with a stabilizing support attached to the bed surface, and not composed of a detachable rigid foot support that itself fulfills the function of an orthosis, with an adapted disposable padded heel boot or protector.

[0014] Therefore, although some devices are known for preventing equinus foot in bedridden patients, none combine this function with pressure ulcer prevention in a product design that is easy to apply, adaptable, hygienic, and reusable. This positions the product as unique in the state of the art and offers high added value in its use.

[0015] SUMMARY OF THE INVENTION. -

[0016] In view of the state of the art, an invention is claimed for a preventative orthosis for equinus foot and anti-decubitus for patients with long stays in bed in a dorsal (face up) position. It basically consists of a rigid, detachable foot support, made up of three independent pieces that fit together at a right angle through complementary grooves to form a foot support structure with the qualification of an orthosis, which keeps it in a 90-degree position with respect to the leg, and a disposable, L-shaped padded heel boot or protector, adapted by means of wrap-around wings on the edges to said support, to prevent pressure sores on the skin.

[0017] More specifically, the rigid, detachable foot support that makes up the anti-equinus orthosis consists of three flat pieces fitted vertically to the bed surface at right angles by means of complementary connecting grooves: a transverse stop with two equidistant sets of vertical grooves entering from its lower edge, and two equal parallel arms with a vertical groove entering from their upper edge, the distance between these two parallel pieces being adjustable according to the pairs of insertion grooves chosen in the transverse piece. The transverse stop piece of the support has the shape of a rectangle with two equal lateral brackets on its support side, with the two sets of grooves, preferably three in number, on the lower edges occupying the same position, resulting in two symmetrical parts with respect to the vertical axis of the rectangle.

[0018] Each parallel arm has the shape of an isosceles trapezoid in which the upper edge with an inward-facing vertical groove is the smaller base side and the lower support edge is formed by two extensions of the larger base side in the manner of the toe and heel of an imaginary shoe.

[0019] These three pieces that make up the structure are made of high-rigidity thermoplastic material, such as polylactic acid (PLA), which is a rigid, hard, sterilizable and biodegradable polymer, which facilitates quick assembly and adjustment to any type and size of foot by playing with the connection slots of the brackets of the transverse stop in the slots of the two lateral arms, resulting in a rigid support that, keeping the patient's foot aligned at a right angle with respect to the leg, allows its natural movement, limiting plantarflexion and favoring dorsiflexion, key factors to prevent equinus foot, a common complication in patients bedridden for long periods.

[0020] Furthermore, the thermoplastic parts are reusable, and can be used on different patients after being disinfected, or even sterilized if necessary.

[0021] In this orthosis, the foot / heel does not rest on a rigid surface, but on the padded boot adaptable to the rigid support, which rests on the transverse stop piece on the part that protects the sole of the foot, between the two parallel arms, and which constitutes the anti-decubitus orthosis, is made of polyester fiber and foam, in the range of 3 to 5 mm, preferably 4 mm, with a double layer design of thickness between 20 to 30 mm, preferably 25 mm.

[0022] The boot's polyester fiber and foam is a specific material that ensures coolness and prevents heat buildup, avoiding the thermal discomfort of conventional materials. The thicker, double-layer design, in addition to offering superior comfort and breathability, promotes even weight distribution across the foot, reducing pressure on critical areas such as the heel and malleolus, thus minimizing the risk of pressure ulcers.

[0023] Therefore, this product is an innovative orthotic solution, as it not only prevents equinus foot but also offers advanced protection against pressure ulcers, all within a user-friendly, hygienic, and adaptable component design. It is a hypoallergenic, comfortable, and effective product for improving the quality of care for bedridden patients and significantly reducing the risk of equinus foot.

[0024] The advantages of using this new orthosis include the following:

[0025] Quick and easy assembly, simply assemble the three pieces of the support on the bed and attach the padded boot, making it easy to use and store.

[0026] Universal adaptability. The orthosis can be adapted to any type of foot by fixing the separation of the lateral arms of the rigid support to the appropriate distance, making it ideal for a wide variety of patients in intensive care.

[0027] Easy access to the patient allows healthcare staff to perform quick interventions, such as wound care, physiotherapy, or medical assessments, without needing to completely remove the orthosis; in many treatments, simply removing the protective boot is sufficient. This design is unique and essential for optimizing healthcare in high-demand environments.

[0028] Postural correction and controlled mobility. The rigid support keeps the patient's foot aligned at a right angle to the leg, ensuring the correct position throughout their stay in bed, and allows natural movement, limiting plantar flexion and promoting dorsiflexion.

[0029] Durable and easy to maintain. The support components are made of a resistant thermoplastic material that is easy to disinfect and even sterilize, making it ideal for hospital environments that require high hygiene standards. It can be used on different patients simply by replacing the padded boot, resulting in cost savings compared to disposable orthopedic devices.

[0030] Exceptional comfort and protection, thanks to the innovatively designed padded boot, which contributes to even pressure distribution and prevents deformities or further injury. Made with high-quality materials for soft, breathable, and hypoallergenic padding, it provides superior comfort to the patient throughout the immobilization period, keeping their skin dry and free from irritation. The padded boot is washable and easy to disinfect, or replace at a low cost.

[0031] Although the boot that is part of the orthosis is completely washable and reusable, which facilitates hygiene in hospital settings, its low cost allows it to be discarded and a new boot used for each patient.

[0032] In short, the innovative design of this new orthosis offers a unique solution on the market. Its combination of ergonomics, functionality, and ease of use ensures significant benefits for both patients and hospitals, contributing to improved healthcare quality and optimized resource allocation.

[0033] FIGURES AND DRAWINGS. -

[0034] For a better understanding of the product described, five figures with illustrative drawings of its components are included at the end of this document.

[0035] Figure 1 shows a perspective view of the orthosis assembled for use, in which the padded boot adapted to the rigid foot support can be distinguished.

[0036] Figure 2 is a perspective view of the separate, assembled support, consisting of the three assembled flat pieces, the cross-stop, and the two parallel arms.

[0037] Figure 3 is an elevation sketch of the transverse support stop, shaped like a rectangle with two lateral brackets, each with three lower connection slots.

[0038] Figure 4 is an elevation sketch of one of the support arms, shaped like a trapezoid extended along its longer base side at the toe and heel, and with the connection groove with the brackets of the incoming stop piece along the upper edge.

[0039] Finally, Figure 5 shows a side elevation view of the orthosis with the foot of a patient lying on the bed, inside the protective boot and this attached to the support.

[0040] METHOD OF IMPLEMENTATION. -

[0041] As can be seen in Figure 1, the new orthosis developed for the protection of the feet of patients who spend a long time lying on their backs against equinus foot malformation and the appearance of pressure sores and bedsores in sensitive areas of the skin, applicable to each foot separately, consists of two elements: the detachable rigid support (1), which is the one that performs the function of anti-equinus prosthesis in these conditions, as it holds the foot and keeps it in the appropriate straight position, and the disposable boot (6), which attached to the support acts as an anti-decubitus orthosis.

[0042] The support is detachable because it consists of three flat pieces fitted together at right angles through connecting grooves, which are mounted vertically resting on the bed surface, as shown in Figure 2. These pieces are shown in detail in Figures 3 and 4, and are: the transverse stop (2), in the shape of a rectangle (8) with two equal lateral brackets (9) on their support side with two equidistant sets of three vertical grooves (3) on the lower edges; and the two equal parallel arms (4), in the shape of an isosceles trapezoid (10) in which the side of the smaller base is the upper edge of the piece, where the vertical groove (5) connecting to the bracket of the stop is located, and the larger base extends to form a lower edge with a pointed tip (11) and a long heel (12) as support areas on the bed

[0043] Note that the support, when mounted, is adjustable to each size and type of foot by simply determining the pairs of slots on the stop piece, closer to or further from the axis of symmetry, thus connecting the side arms.

[0044] The three component parts of the support are made of high-strength polylactic acid (PLA) as the preferred material, and their manufacture follows any conventional plastic injection molding process, based on predetermined pattern templates with exact dimensions. The dimensions for correct use have been established for a transverse stop piece 250 mm wide between the ends of the brackets, 90 mm for the central rectangle, and 210 mm high; and for the parallel arms, 244 mm long between the toe and heel ends of the lower edge, 60 mm along the upper edge where the vertical connecting groove is located, and 110 mm high.

[0045] The padded heel boot or protector is L-shaped, with wrap-around wings (7) at the edges for proper adaptation to the support, in which the sole of the foot must rest on the transverse stop, as shown in Figure 5. This boot is made of 4 mm polyester fiber and foam, with a double-layer design for a thickness of 25 mm, greater than that of this type of protector. The two components of this orthosis, rigid foot support and protective boot, comply with the quality and safety standards established by the Medical Devices Regulation (MDR 2017 / 745) for Class I medical devices.

Claims

1. CLAIMS 1. An orthosis for preventing equinus foot and decubitus for bedridden patients with long stays in bed in a supine position, characterized by a rigid, detachable foot support (1), consisting of three flat pieces fitted vertically to the bed surface and at a right angle by means of connecting grooves: a transverse stop (2) with two equidistant sets of vertical grooves (3) entering from its lower edge and two equal parallel arms (4) with a vertical groove (5) entering from their upper edge, the distance between these two parallel pieces being adjustable according to the pairs of insertion grooves chosen in the transverse piece; and by a disposable, L-shaped padded heel boot or protector (6), adapted by means of enveloping wings (7) on the edges to said support, in such a way that the part protecting the sole of the foot rests on the transverse stop piece between the two parallel arms.

2. Orthosis for preventing equinus foot and decubitus for bedridden patients, according to claim 1, characterized in that the transverse stop piece of the support has the shape of a rectangle (8) with two lateral brackets (9) equal on their support side with two sets of three grooves (3) on the lower edges in the same position, resulting in two symmetrical parts with respect to the vertical axis of the rectangle, and in that each parallel arm has the shape of an isosceles trapezoid (10) in which the upper edge with an incoming vertical groove (5) is the smaller base side and the lower support edge is configured by two extensions of the larger base side as a toe (11) and heel (12).

3. Orthosis for the prevention of equinus foot and anti-decubitus for bedridden patients, according to claim 1, characterized in that the three flat pieces that make up the support structure of the foot are made of high rigidity thermoplastic material.

4. Orthosis for the prevention of equinus foot and anti-decubitus for bedridden patients, according to claim 3, characterized in that the thermoplastic material in which the three flat pieces of the support structure are manufactured is high-strength polylactic acid (PLA).

5. Orthosis for the prevention of equinus foot and antidecubitus for bedridden patients, according to claim 1, characterized in that the boot or padded heel protector is made of 3-5 mm polyester fiber and foam, with a double-layer design with a thickness between 20-30 mm

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