IT201800002704A1 - Gradual compression biomedical device for the support and optimization of the skin scar - Google Patents

Description

BIOMEDICAL DEVICE WITH GRADUAL COMPRESSION FOR THE

SUPPORT AND OPTIMIZATION OF THE SKIN SCAR

DESCRIPTION

Technical field of the invention

The present invention refers to a biomedical device configured to exert a compression and a support on a skin lesion for the purpose of its healing.

Background

Skin lesions, particularly those directly resulting from open surgery, have a high recurrence and their treatment plays an important role in the health procedures of any hospital or medical center in general.

In particular, there are frequent complications of surgical interventions, such as above all cicatricial hypertrophy, wound dehiscence, seroma, hematoma and infectious events.

From a clinical point of view, pathological scarring - in particular hypertrophic, keloid or dehiscent - is precisely one of the most frequent post-operative complications, as well as a cause of medico-legal subpoenas. Specifically, this complication compromises both the aesthetic and functional result of the intervention, sometimes resulting in a deficit of flexion-extensor motility of the limbs as well as prolonged pain or dysaesthetic symptoms.

From an analysis of the literature and of the market, the only known devices supplied for the treatment of the skin lesion are compression sheaths, applied in an undifferentiated way on the limbs or in the different parts of the body, which produce a single transverse pressure action, in the distal-proximal direction, on the edges of the lesion itself, in order to reduce swelling and fluid accumulation. In this context, the biomedical devices currently on the market are aimed at promoting adhesion on the different planes of the surgically treated tissues.

Consequently, known devices are neither designed nor optimized to specifically affect healing. Furthermore, they do not allow a personalization or a realization dedicated to a particular body district.

Therefore, despite said high incidence and considerable clinical relevance of skin lesions, the state of the art does not offer optimized devices for their treatment, and in particular to promote physiological healing.

Summary of the invention

The technical problem posed and solved by the present invention is that of providing a biomedical device, in particular for post-surgical use, which allows to overcome one or more of the drawbacks mentioned above with reference to the known art.

This problem is mainly solved by a device according to claim 1.

Preferred features of the present invention are the subject of the dependent claims.

The device of the invention is specifically configured to mechanically affect the healing process, preventing hypertrophic, keloid or dehiscent scars.

In particular, from the medical-clinical point of view, the invention starts from the observation, by the inventors, that a scar subjected to irregular tension on the margins, such as those deriving from incisions not perpendicular to the course of the muscle fibers (i.e. not parallel to the Langer undervoltage lines <1>), tends to evolve towards hypertrophy. This occurs because myofibroblasts, the cells involved in the proliferative phase of scarring, are sensitive to mechanical stress, which is transduced into a proliferative stimulus for the cells themselves, simultaneously promoting collagen synthesis. According to the Inventors, this transduction, and consequent tendency to hypertrophy, is reduced if the wound is compressed with a vector

<1> Langer K., “On the anatomy and physiology of the skin. I. The cleavability of the cutis ", IBr J Plast Surg, vol. 31, pp. 3-8, 1978.

orthogonal to the skin plane and oriented from the surface to the depth of the tissue. If the tension is exerted on the margins with a vector parallel to the cutaneous plane and oriented in such a way as to induce divergence of the cutaneous margins, the wound inevitably tends to dehiscence as well as to dystrophy. Consequently, the theory behind the invention is that, by compressing the surgical wound with a force expressed by a longitudinal vector orthogonal to the skin plane and oriented from the surface to the depth of the tissue, associated with a force expressed by a transverse vector parallel to the cutaneous and oriented in such a way as to induce convergence of the margins, both scarring hypertrophy and wound dehiscence can be prevented.

The device of the invention is based on a central compression element suitable for exerting said longitudinal force, associated, in particular with a substantially clamp-like configuration, to a pair of lateral reinforcing elements configured to exert said distal-proximal transverse action of approaching the edges of the lesion.

Advantageously, the device also provides flexible or elastically deformable arms, at least one for each reinforcing element, which, when pulled, allow to define the amount of compression applied by the central element and / or the action of approaching the skin flaps exerted. from the lateral reinforcement elements.

The device therefore allows a mechanical support for the treatment and optimization of the lesion.

In a preferred embodiment, the lateral arms can be operated by means of ropes, or cables / tie rods, in tension which allow to:

(a) compress the lesion, in a differential and preferably gradual manner between the injured area and the rest of the body area, thus favoring both the reduction of the hematoma and a more effective healing, and this through the aforementioned central compression element;

(b) bring the edges of the scar gradually and sustainably over time, thus favoring the achievement of a better structure of the fibrotic connective tissue forming during the healing process as well as a better aesthetic result of the mature scar (thickness, shape and reduced visibility ), and this by means of the aforementioned lateral reinforcement elements.

In a preferred embodiment, the extent of compression and transverse action on the flaps can vary both within the same treatment on a specific skin lesion, and in such a way as to customize said forces and / or make them specific according to the type of body area affected and the initial and desired conditions of the lesion itself.

In particular, the device of the invention can allow to modulate, by intensity and vector, the compression and the transverse action on the scar and neighboring tissues, thus favoring the overcoming of the clinical, functional and aesthetic drawbacks of the prior art.

The invention can therefore allow modularity and adaptability of the force exerted on the skin lesion.

The device lends itself to a realization that allows to obtain lightness, wearability, maneuverability and universality of application for any body area, with particular effectiveness in the case of brachioplasty operations.

Other advantages, characteristics and methods of use of the present invention will become evident from the following detailed description of some embodiments, presented by way of non-limiting example.

Brief description of the figures

Reference will be made to the figures of the attached drawings, in which:

Figure 1 shows a schematic front perspective view of a biomedical device according to a first preferred embodiment of the present invention, in a preparatory configuration for use on a skin lesion;

Figure 2 shows a schematic front view of the biomedical device of Figure 1, in the same configuration as the latter;

Figure 3 shows a schematic front perspective view of the biomedical device of Figure 1, highlighting the operating modes for compression of the lesion;

Figure 4 refers to a configuration of the device similar to that of Figure 3, in front view;

Figure 5 shows a schematic front view of the biomedical device of Figure 1, highlighting the vector forces that are generated, in use, for the compression of the wound and the approach of the relative flaps;

Figure 6 shows a schematic front perspective view of a biomedical device according to another preferred embodiment of the present invention, in a preparatory configuration for use on a skin lesion;

Figure 7 shows a schematic front perspective view of the biomedical device of Figure 6, in the same configuration as the latter;

Figure 8 shows a schematic front perspective view of the biomedical device of Figure 6, highlighting the operating modes for compression of the lesion.

The dimensions, curvatures and vector actions represented in the figures introduced above are intended as examples and are not necessarily shown in proportion.

Detailed description of preferred embodiments

With reference initially to Figures 1 and 2, a biomedical device according to a preferred embodiment of the present invention is generally denoted with 1.

In the example considered, the device is intended for the treatment of a skin lesion following a brachioplasty operation, in which excess skin and adipose tissue are removed at the inner face of an arm. The latter is represented schematically and denoted by B.

In this surgery, the scar, or lesion, L, is present in an area under the armpit or along the crease up to the elbow, in the lower portion of the arm.

In general terms, the skin lesion is understood to be defined by two flaps extending in a longitudinal direction L orthogonal to the view plane of Figure 2.

The device 1 mainly comprises a central pressure element 100, a pair of lateral reinforcing elements 101 and 102 and a corresponding pair of flexible arms 103 and 104, made in one piece with each other to define a main body 110 of the device 1 same.

Preferably, the main body 110 is endowed with an elastic deformability, or flexibility, different in correspondence with the reinforcing elements 101 and 102 with respect to the lateral arms 103 and 104, the latter being less rigid than the former.

The main body 110 has an enveloping conformation, in such a way that it is circumscribed to the body area affected by the skin lesion.

Preferably, the main body 110 is made of a plastic material, in particular sectioned in a group comprising PETG (polyethylene terephthalate glycol), PLA [CF1] (polylactic acid).

The main body 110 can be made by extrusion or 3D printing.

The central pressure element 100 is shaped in such a way as to exert, in use, a compression on the skin lesion, i.e. a pressure action along an axis lying on the plane of Figure 2 and denoted by P. As will be illustrated later, the entity this compression is determined, and possibly modulable / adjustable, by means of a traction exerted at the free ends 113 and 114 of the flexible arms 103 and 104.

Lateral to the pressure element 100 extend, in a transverse direction T orthogonal to the direction L and to the direction P, the aforementioned reinforcing elements 101 and 102, one at each (transverse) side of the central pressure element 100. The elements lateral reinforcements 101 and 102 are configured to act each on a respective flap of the skin lesion in such a way as to exert a transverse action of approaching said flaps in the direction T and towards distal-proximal with respect to the central part of the lesion.

Advantageously, the lateral reinforcement elements 101 and 102 define an overall pincer configuration, in which the central pressure element 100 represents a shaped recess between the lateral margins of said pincer conformation. In particular, the transverse clamping action is exerted, in use, by the side walls or external slopes of the reinforcing elements 101 and 102, denoted respectively with 111 and 112.

In the present example, the lateral reinforcing elements 101 and 102 each have a substantially "U" or "V" conformation in cross section, in which external branches 111 and 112 of each of said "U" or "V" conformations exercise said transverse action of approaching the edges of the lesion.

Overall, the lateral reinforcement elements 101 and 102 and the central pressure element 100 define, in the example shown, an overall "M" conformation in cross section.

The external profile of the pressure element 100 can be obtained starting from an elliptical geometry having major and minor axes that lie on the plane of Figure 2.

The flexible arms 103 and 104 are, in the present example, elastically deformable. They each branch off from a respective lateral reinforcement element 101 and 102, on the transversely opposite side of the latter with respect to the central pressure element 100.

The flexible arms 103 and 104 of the present example each have a substantially arched conformation to wrap the body area affected by the skin lesion, in particular an upper limb in the application exemplified here.

The flexible arms 103 and 104 are configured to be tractionable at the aforementioned respective free ends 113 and 114, each arranged on the opposite side of a respective lateral reinforcement element 101, 102, in such a way as to allow an adjustment of the compression exerted on the lesion skin by said central pressure element 100 and / or by the transverse action exerted on the edges by the reinforcing elements themselves.

To this end, the device 1 also includes, in the present embodiment, traction means, denoted as a whole with 105 and shown by way of example in Figures 3 and 4.

In the present example, the traction means 105 comprise a pair of tensioning elements 501, 502, or cables or traction cords, each associated with a respective flexible arm 103, 104, and in particular anchored to a respective free end 113, 114 of the latter.

The tie rods 501 and 502 can be made of plastic or metal material, or also of metal, for example steel, coated with plastic material, for example Nylon.

The traction means 105 also comprise a tensioning element 503, in particular in the form of a roller or washer, of the tie rods 501, 502 and therefore of the associated flexible arms 103, 104.

The tie rods 501, 502 can be recalled to wind on the wheel 503 by rotating the latter.

By turning the wheel 503, or by operating a similar traction element, the tension of the cables can also be adjusted.

The figures introduced up to now show the device 1 in an initial configuration for application on the skin lesion. In particular, in the initial configuration the device 1 is in contact with the arm, or other affected body area, at the level of the central portion 100. This initial configuration provides for a complete opening of the arms 103 and 104, since no traction is exerted at the level of the cables 501 and 502.

At the time of use on a patient, the cables 501 and 502 are pulled and draw the arms 103 and 104 to wrap around the body district, bringing the reinforcing elements 101 and 102 closer to the lesion and inducing the desired compression by means of the element central 100.

In general terms, as mentioned above, by acting on the cables 501 and 502, the extent of the pinching action exerted by the lateral reinforcing elements 101 and 102 and the extent of the compression operated by the central element 100 are adjusted.

An exemplary representation of the vector force actions exerted on the body district is shown in Figure 5.

The wheel 503, or an equivalent traction element, can be equipped with a safety system that allows the immediate release of the entire device, for example by simply pressing a button, if there is a need.

Figures 6 to 8 refer to a variant embodiment of the device, denoted here by 2, which has a plurality of pairs of flexible arms 203, 204, 203 ', 204', each of the type already described, and a plurality of corresponding pairs of reinforcing elements 101, 102, 101 ', 102', also here each of the type already described, associated with a common central pressure element 200. The latter also has the same characteristics already described, and compatible longitudinal extension with the application of the aforementioned plurality of arms and reinforcing elements.

According to a preferred mode of use, the device of the invention can be worn by the patient after surgery and possibly for the entire postoperative period until complete healing.

The device can be used in combination with a compressive sheath of the type currently available on the market. In this variant, the compression sheath represents the element in direct contact with the skin. This sheath can be made of an elastic, natural or synthetic yarn, for example natural rubber or rubber, polyamide (Nylon), Lycra and / or cotton.

The portion of the sheath in contact with the scar can be coated with a layer of silicone, which helps the healing process.

The sheath can possess breathability properties and adhere perfectly to the skin.

In case of application after brachioplasty, the elastic compression sheath for the arm may be of the type already available on the market. This sheath adapts to the arm once worn by the patient.

The reinforcing elements and the flexible arms can be directly mounted on the sheath, which form bands that wrap the sheath itself. These elements and arms can be sewn onto the sheath in such a way that the reinforcing element is anchored to the sheath in the portion in contact with the scar while the remaining portion of the band is initially not in contact with the sheath ("initial configuration").

As already mentioned, the device is suitable for low weight embodiments, in order to allow the patient to carry out a normal daily life.

In addition, the device can be easily worn and washable.

The device easily adapts to the clinical and patient needs, also in terms of anthropometry of the specific subject and of the particular body area affected by the lesion.

It will be understood that the device of the invention lends itself to a modular construction, also for a sequential application of a multiplicity of devices (or units) along a skin lesion.

Furthermore, the device lends itself to being made with different types of material and allows a targeted design to predict specific loads and deformations distributed on the device and on the body area concerned.

As mentioned above, the biomedical device according to the invention also lends itself to being made by 3D printing, in particular as regards its main body.

The invention also relates to a method of treating a skin lesion, which uses a biomedical device as described above and defined in the following claims. This method preferably provides for a progressive application of increasing compression and / or transverse actions on the lesion itself by means of traction exercised by means of the aforementioned dedicated traction means.

The present invention has been described up to now with reference to preferred embodiments. It is to be understood that there may be other embodiments that refer to the same inventive core, as defined by the scope of the claims set out below.

Claims (14)

CLAIMS 1. Biomedical device (1) for the treatment of a skin lesion defined by two longitudinal flaps, which biomedical device (1) comprises: - a central pressure element (100), shaped in such a way as to exert a compression on the skin lesion; - a pair of reinforcing elements (101, 102), integral with said central pressure element (100) and each arranged at a respective side thereof, which reinforcing elements (101, 102) are configured to act each on a respective flap of the skin lesion in such a way as to exert a transverse action of approaching the flaps themselves; - a pair of flexible arms (103, 104), in particular elastically deformable, each branching off from a respective lateral reinforcement element (101, 102), on the transversely opposite side of the latter with respect to said central pressure element (100), said flexible arms (103, 104) being tractionable at a respective free end (113, 114) of each of them, in such a way as to determine, and preferably regular, said compression and transverse action exerted on the skin lesion by said pressure element central (100) and said reinforcing elements (101, 102), in which said biomedical device (1) is configured in such a way as to be circumscribed to the body area affected by the skin lesion. Device (1) according to claim 1, wherein said central pressure element (100), reinforcing elements (101, 102) and flexible lateral arms (103, 104) are made integral, in one piece, with each other the others. Device (1) according to claim 1 or 2, wherein said reinforcing elements (101, 102) have higher stiffness than said flexible arms (103, 104). Device (1) according to any one of the preceding claims, which has a main body (110) made of a plastic material, in particular selected from a group comprising PETG (polyethylene terephthalate glycol), PLA (polylactic acid). 5. Device (1) according to any one of the preceding claims, in which said reinforcing elements (101, 102) define an overall gripper configuration, said central pressure element (100) defining a shaped recess between lateral margins (111, 112) of said pincer conformation. Device (1) according to any one of the preceding claims, in which said reinforcing elements (101, 102) each have a substantially "U" or "V" conformation in cross section and in which external branches (111, 112) of each of said "U" or "V" conformations exert said transverse action of approaching the edges of the lesion. Device (1) according to any one of the preceding claims, in which said reinforcing elements (101, 102) and said central pressure element (100) define an overall "M" conformation in cross section. Device (1) according to any one of the preceding claims, in which said flexible arms (103, 104) each have a substantially arched shape to envelop the body area affected by the skin lesion. Device (1) according to any one of the preceding claims, comprising traction means (105) of said flexible arms (103, 104), configured to exert a pulling action at said free ends (113, 114) of said arms flexible (103, 104). Device (1) according to the preceding claim, wherein said traction means (105) comprise a pair of tie elements (501, 502), each associated with a respective flexible arm (103, 104). Device (1) according to claim 9 or 10, wherein said traction means (105) comprise a tensioning element (503), in particular in the form of a roller, of said flexible arms (103, 104). 12. Device (2) according to any one of the preceding claims, which has a plurality of pairs of flexible arms (203, 204, 203 ', 204') associated with a common central pressure element (200). 13. Device (2) according to any one of the preceding claims, which has a plurality of pairs of reinforcing elements (101, 102, 101 ', 102') integral with a common central pressure element (200). Device (1) according to any one of the preceding claims, comprising a sheath or gauze covering an internal surface of at least said central pressure element (100).