WO2019159065A1

WO2019159065A1 - Gradual compression medical device for supporting and optimizing the cutaneous scar

Info

Publication number: WO2019159065A1
Application number: PCT/IB2019/051149
Authority: WO
Inventors: Alessio GIZZI; Giovanni Francesco MARANGI; Francesco Segreto; Cristina FALCINELLI; Paolo PERSICHETTI; Simonetta FILIPPI
Original assignee: Università Campus Bio-Medico Di Roma
Priority date: 2018-02-15
Filing date: 2019-02-13
Publication date: 2019-08-22
Also published as: EP3752076A1; IT201800002704A1

Abstract

A biomedical device (2) for the treatment of a cutaneous lesion defined by two longitudinal edges, which device comprises: - a central pressing element (200), shaped in order to exert, in use, a compression on the cutaneous lesion; - a plurality of pairs of reinforcing elements (201, 202, 201 ', 202') integral with said central pressing element (200), arranged each at a respective side thereof and configured to act each on a respective edge of the lesion in such a way as to exert a transversal action of approaching the same edges; - a plurality of pairs of elastic arms (203, 204, 203', 204'), each originating from a respective lateral reinforcing element (201, 202, 201 ', 202') on the opposite side of the latter with respect to said central pressing element (200); and - a traction roller with pulling elements (105) of the elastic arms (203, 204, 203', 204'), in such a way as to allow an adjustment of the compression exerted on the cutaneous lesion, which biomedical devices (2) is configured so as to be arranged circumscribed to the body district affected by the cutaneous lesion.

Description

GRADUAL COMPRESSION MEDICAL DEVICE FOR SUPPORTING AND OPTIMIZING THE CUTANEOUS SCAR

DESCRIPTION

Technical field of the invention

The present invention is related to a biomedical device configured to apply a compression on a cutaneous lesion and to support the cutaneous lesion for healing purpose.

Background

The cutaneous lesions, in particular those directly consequent to open surgical procedures, have a high recurrence rate and their treatment plays a crucial role in the healthcare procedures of hospitals or medical centres.

In particular, frequent complications of the surgical interventions may occur, such as cicatricial hypertrophy, wound dehiscence, seroma, haematoma and infective events.

From a clinical point of view, the pathological healing - in particular hypertrophic, keloidal or dehiscent healing - is one of the most frequent post-operative complications, apart from the cause of medical-legal subpoenas. Such complication jeopardizes both aesthetical and functional results of the intervention, sometimes causing a deficit of the flexor-extensor motility of the limbs apart from prolonged algic or dysesthetic symptoms (for example in case of Brachioplasty¹ intervention).

Scientific evidence shows that optimum healing can be obtained through a careful balance of the loads acting on the wound, which have to be applied according to multiple directions. Moreover, the loads acting on the healing have not to limit the normal blood flow not to incur in a blockage of blood circulation, nor even to induce accumulation of liquids and formation of haematomas²

¹ Sisti et al.“Complications associated with brachioplasty: A literature review” Acta Biomed 2018;88(4):393-402.

² Arabi et al.“Mechanical load initiates hypertrophic scar formation through decreased cellular apoptosis” FASEB J. 2007; 21 :3250-3261 , and Agha et al.“A Review of the Role of Mechanical Forces in Cutaneous Wound Healing” Journal of Surgical Research 201 1 ; 171 :700-708. From a literature and market analysis, so far, the known exiting devices for the treatment of cutaneous lesions are compressive sheaths, applied in an undifferentiated way on limbs or in the different body districts and producing one single transversal loading action, in the distal-proximal direction, on the edges of the lesion itself, in order to reduce swelling and accumulation of liquids. In this context, the biomedical devices currently available on the market are designed to promote adhesion on the different levels of the surgically treated tissues, then they do not provide a specific action for the functional and aesthetical optim ization of the scar, nor for the limitation of the formation of haematomas³

Consequently, the existing devices are not designed nor optimized to affect specifically on healing. Moreover, they do not allow customization nor a dedicated implementation to a particular body district.

Therefore, notwithstanding said high incidence and considerable clinical importance of the cutaneous lesions, the state of the art does not offer devices optimized for their treatment and in particular to promote physiological healing⁴.

Summary of the invention

The technical problem placed and solved by the present invention is to provide a biomedical device, in particular for postoperative use, allowing to obviate one or more of the drawbacks mentioned above with reference to the known art.

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

Preferred features of the present invention are outlined in the depending claims.

The device of the invention is configured specifically to affect mechanically the healing process, by preventing hypertrophic, keloidal 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 for example those deriving from incisions not perpendicular to

³ Blattner et al.“The use of a suture retention device to enhance tissue expansion and healing in the repair of scalp and lower leg wounds” JAAD Case Reports 2018; 4:655-661 .

⁴ Stephens et al. “Developing the tissue viability seating guidelines” J. Tissue Viability 2018; 27:74-79 the course of the muscle fibres (that is not parallel to the lines of minimum tension of Langer⁵), tends to develop hypertrophy. This condition occurs since the myofibroblasts, the cells involved in the proliferative healing phase, are sensible to the mechanical stress, which is transduced into a proliferative stimulus for the cells themselves, by promoting at the same time the synthesis of collagen. According to the inventors’ observation, such transduction, and consequent tendency to hypertrophy is reduced if the wound is compressed with a vector orthogonal to the dermal plane and oriented by 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 to induce divergence of the cutaneous margins, the wound inevitably tends to dehiscence apart from dystrophy. Consequently, the theory underlying the invention is that, by compressing the surgical wound with a force expressed by a longitudinal vector orthogonal to the cutaneous plane and oriented by the surface to the depth of tissue, associated to a force expressed by a transverse carrier parallel to the cutaneous plane and oriented so as to induce convergence of the margins, both cicatricial hypertrophy and wound dehiscence can be prevented.

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

Advantageously, the device further provides flexible, or elastically deformable, arms, at least one for each reinforcing element which, pulled, allow at the same time to define both the extent of the compression applied by the central element and the action for approaching the cutaneous edges exerted by the lateral reinforcing elements.

Advantageously, the invention provides one single device configured so as to exert simultaneously such actions.

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

In a preferred embodiment, the lateral arms can be manoeuvred through ropes, or cables/pulling elements, in tension allowing:

⁵ Langer K., On the anatomy and physiology of the skin. I. The cleavability of the cutis”, IBr J Plast Surg, vol. 31 , pages 3-8, 1978. (a) to compress the lesion, differentially and preferably gradually between the lesioned area and the remaining body district, thus favouring both the reduction of haematoma and more effective healing, and this by means of the above-mentioned compressing central element;

(b) to approach the scar edges in a gradual and sustained way in time, thus favouring to obtain a better structure of the fibrotic connective tissue which has formed during the healing process, as well as a better aesthetical yield of the mature scar (thickness, shape and reduced visibility) and this by means of the above-mentioned lateral reinforcing elements.

In a preferred embodiment, the extent of the compression and transversal action on the edges can vary both within the same treatment on a specific cutaneous lesion, and so as to customize said forces and/or make them specific depending upon the type of the involved body district and the initial and wished conditions of the lesion itself.

In particular, the device of the invention can allow to modulate, by intensity and vector, both the compression and the transverse action on the scar and on the neighbouring tissues, thus by favouring to overcome the drawbacks of the clinical, functional and aesthetical type of known art.

The invention then can allow modularity and adaptability of the force exerted on the cutaneous lesion.

The device is suitable for an implementation allowing to obtain lightness, wearability, manoeuvrability and universality of application for each body district, with particular effectiveness in case of operations of brachioplasty.

Other advantages, features and use modes of the present invention will result evident from the following detailed description of some embodiments, shown by way of example and not for limitative purposes.

Brief description of the figures

The figures of the enclosed drawings will be referred to, wherein:

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

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

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

^■ Figure 4 relates to a configuration of the device analogous to that of Figure 3, in front view;

^■ Figure 5 shows a schematic front view of the biomedical device of Figure 1 , by highlighting the vector forces generating, in use, for the compression of the wound and the approaching of the related edges;

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

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

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

The sizes, curves and vector actions represented in the above-introduced figures are to be meant as exemplifying and they are not necessarily shown in proportion.

Detailed description of preferred embodiments

By firstly referring to Figures 1 and 2, a biomedical device according to a preferred embodiment of the present invention is designated as a whole with 1 .

In the considered example, the device is meant for the treatment of a cutaneous lesion following a brachioplasty operation, wherein both the skin excess and adipose tissue excess are removed at the inner face of an arm. The latter is represented schematically and designated with B.

In this operation, the scar or lesion, L, is present in an underarm area or along the fold as far as the elbow, in the lower portion of the arm.

In general terms, the cutaneous lesion is defined by two edges extending in a longitudinal direction L orthogonal to the view plane of Figure 2. The device 1 mainly comprises a central pressing element 100, a pair of lateral reinforcing elements 101 and 102 and a corresponding pair of the flexible arms 103 and 104, implemented in one single piece with one another to define a main body 110 of the device 1 itself.

Preferably, the main body 110 is provided with elastic deformability, or flexibility, different at the reinforcing elements 101 and 102 with respect to the lateral arms 103 and 104, the latter being less stiff than the first ones.

The main body 110 has a wrapping shape to circumscribe the body district affected by the cutaneous lesion.

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

The main body 110 can be implemented by means of extrusion or 3D printing.

The central pressing element 100 is shaped in such a way as to exert, in use, a compression on the cutaneous lesion, that is a pressing action according to an axis lying on the plane of Figure 2 and designated with P. As it will be illustrated hereinafter, the extent of such compression is determined, and in case modular/adjustable, by means of a traction exerted at free ends 113 and 114 of the flexible arms 103 and 104.

The above-mentioned reinforcing elements 101 and 102 extend laterally to the pressing element 100, according to a transverse direction T orthogonal to the direction L and to the direction P, one at each (transverse) side of the central pressing element 100. The lateral reinforcing elements 101 and 102 are configured to act each on a respective edge of the cutaneous lesion so as to exert a transverse action for approaching the edges themselves according to the direction T and towards distal-proximal with respect to the central portion of the lesion.

Advantageously, the lateral reinforcing elements 101 and 102 define an overall gripper configuration, wherein the central pressing element 100 represents a shaped indent between side margins of said gripper configuration. In particular, the action of transverse gripping is exerted, in use, by side walls or external sides of the reinforcing elements 101 and 102, designated with 111 and 112, respectively.

In the present example, each lateral reinforcing element 101 and 102 has a substantially“U”- or“V”-shape in cross-section, wherein external branches 111 and 112 of each of said,“U” or“V”-like conformations exert said transverse action of approaching the edges of the lesion.

As a whole, the lateral reinforcing elements 101 and 102 and the central pressing element 100 define, in the represented example, an overall“M”-like conformation in cross section.

The outer profile of the pressing element 100 can be obtained starting from an elliptic geometry having major and minor axis lying on the plane of Figure 2.

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

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

The flexible arms 103 and 104 are configured to be tractionable at the above- mentioned respective free ends 113 and 114, each one arranged on opposite side of a respective lateral reinforcing element 101 , 102, so as to allow an adjustment of the compression exerted on the cutaneous lesion by said central pressing element 100 and/or of the transverse action exerted on the edges by the reinforcing elements themselves.

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

In the present example, the traction means 105 includes a pair of pulling elements 501 , 502, or cables or pulling ropes, each associated with a respective flexible arm 103, 104, and in particular anchored to a respective free end 113, 114 of the latter. The pulling elements 501 and 502 can be made of plastic or metallic material, or even of metal, for example steel, covered with plastic material, for example Nylon.

The traction means 105 further comprise a tensioning element 503, in particular in form of a roller o washer, of the pulling elements 501 , 502 and then of the associated flexible arms 103, 104.

The pulling elements 501 , 502 can be drawn to wrap on the roller 503 by rotating the latter.

By rotating the roller 503, or by actuating an analogous traction element, the tension of the cables can also be adjusted.

The so far illustrated figures show the device 1 in an initial configuration of application on the cutaneous lesion. In particular, in the initial configuration the device 1 is in contact with the arm, or other involved body districts, at the level of the central portion 100. Such initial configuration provides a complete opening of the arm 103 and 104, not being exerted any traction at the level of the cables 501 and 502.

Upon using on a patient, the cables 501 and 502 are tractioned and draw the arms 103 and 104 to wrap around the body district, by approaching the reinforcing elements 101 and 102 to the lesion and inducing the wished compression by means of the central element 100.

In general terms, as said above, by acting on the cables 501 and 502 the extent of gripping action exerted by the lateral reinforcing elements 101 and 102 and at the same time the extent of the compression made by the central element 100 are adjusted.

An exemplifying representation of the vector force actions which are exerted on the body district is shown in Figure 5. Such actions preferably provide the presence of a layer interposed between the device and the skin to prevent them from coming directly in contact, said layer being for example implemented, or comprising, a compressive sheath.

The roller 503, or an equivalent traction or tensioning element, can be equipped with a safety system which allows to release immediately the whole device, for example by simply pressing a button, if required. Such roller 503 preferably is arranged outside the device of the invention, so as to result to be easily accessible even when the device itself is associated to a postoperative sheath, in particular so as to result external, in use, even to the above-mentioned postoperative sheath.

Figures 6 to 8 relate to an embodiment variant of the device, herein designated with 2, having a plurality of pairs of flexible arms 203, 204, 203’, 204’, each one of the already described type, and a plurality of corresponding pairs of reinforcing elements 101 , 102, 101’, 102’, even in this case each one of the already described type, associated to a common central pressing element 200. The latter too has the same already described features, and longitudinal extension compatible with the application of the above-mentioned plurality of arms and reinforcing elements. The presence of multiple independent arms guarantees the application of modular loads, adaptable to the specific patient.

Based upon a preferred use mode, the device of the invention can be worn by the patient after the surgical operation and in case for the whole postoperative period until complete healing. The complete and simple accessibility of the tensioning roller 503 during the postoperative period allows to vary the load applied on the cutaneous lesion depending upon the different phases of the cicatricial process.

The device can provide the combined use with a compressive sheath of the type currently already present on the market. The compressive sheath, in this embodiment variant, represents the element in direct contact with the skin. Such sheath can be made of elastic, natural or synthetic yarn, for example rubber or natural rubber, polyamide (Nylon), Lycra and/or cotton.

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

The sheath can have breathability property and it can adhere perfectly to the skin.

In case of application after a brachioplasty operation, the elasto-compressive sheath for the arm can be of the type already available on the market. Such sheath adapts itself to the arm once it is worn by the patient.

The reinforcing elements and the flexible arms can be directly assembled on the sheath, which elements and arms implement bands wrapping the sheath itself. Such elements and arms can be sewn on the sheath so that the reinforcing element results to be anchored to the sheath in the portion in contact with the scar, whereas the remaining band portion results at first to be not in contact with the sheath (“initial configuration”).

In other words, the reinforcing and traction elements such as the central body 110, the reinforcing elements 101 , 102 and the flexible arms 103, 104, as well as the hooking elements such as for example the pulling cables and the rollers 501 , 502, 503, are not meant to come in direct contact with the skin of the patient when the device is used in combination with a postoperative compressive sheath. This minimizes the problems associated to biocompatibility and allergies and increases the application comfort.

All above-mentioned elements, in fact, can act, in use, inside the postoperative period sheath. In particular, the above-mentioned elements can be inserted (spun or extruded) at the same time or subsequently to a postoperative sheath, and they contribute in reinforcing the same with the purpose of optimizing the healing after a surgical operation.

As already mentioned, the device is suitable for low-weight implementations, with the purpose of allowing the patient to carry on normal everyday life.

Moreover, the device can be easily worn and washed.

The device fits easily to the clinical needs and of the patient, even in terms of anthropometry of the specific subject and of the particular body district affected by the lesion.

It will be understood that the device of the invention is suitable for a modular implementation, even for an application in sequence of a plurality of devices (or units) along with a cutaneous lesion.

Moreover, the device is suitable to be implemented with different types of material, and it is designed to provide specific loads and deformations distributed on the device and the involved body district.

As mentioned above, the biomedical device according to the invention is further suitable to be implemented by means of 3D printing, in particular as far as its main body is concerned. Such specificity provides the customized design and implementation of the device both based upon the patient anatomy and the specific shape of the scar resulting from the surgical operation. The invention further relates to a method for treating a cutaneous lesion, which uses a biomedical device as described above and defined in the following claims. Such method preferably provides a progressive application of increasing compression and/or transverse actions on the lesion itself by means of the traction exerted by the above-mentioned dedicated traction means.

The present invention has been sofar described with reference to preferred embodiments. It is to be meant that other embodiments belonging to the same inventive core may exist, as defined by the protective scope of the herebelow reported claims.

Claims

1. A biomedical device (2) for the treatment of a cutaneous lesion defined by two longitudinal edges, which biomedical devices (2) comprises:

- a common central pressing element (200), shaped in such a way as to exert, in use, a compression on the cutaneous lesion;

- a plurality of pairs of reinforcing elements (201 , 202, 201’, 202’), integral with said common central pressing element (200) and arranged each at a respective side thereof, which reinforcing elements (201 , 202, 201’, 202’) are configured to act each on a respective edge of the cutaneous lesion in such a way as to exert a transversal action of approaching the same edges;

- a plurality of pairs of flexible arms (203, 204, 203’, 204’) associated to said common central pressing element (200), in particular elastically deformable, each originating from a respective lateral reinforcing element (201 , 202, 201’, 202’), on the transversely opposite side thereof with respect to said common central pressing element (200), said flexible arms (203, 204, 203’, 204’) being tractionable at a respective free end (113, 114) of each of them, in order to determine, and preferably adjust, said compression and transversal action exerted upon the cutaneous lesion by said common central pressing element (200) and by said reinforcing elements (201 , 202, 201’, 202’),

wherein said biomedical device (2) is configured so as to be arranged circumscribed to the body district affected by the cutaneous lesion.

2. The device (2) according to claim 1 , wherein said common central pressing element (200), reinforcing elements (201 , 202, 20T, 202’) and flexible lateral arms (203, 204, 203’, 204’) are made integral, in one piece, with one another.

3. The device (2) according to claim 1 or 2, wherein said reinforcing elements (201 , 202, 20T, 202’) have greater stiffness than said flexible arms (203, 204, 203’, 204’).

4. The device (2) according to anyone of the preceding claims, which has a main body (110) made of a plastic material, in particular selected in a group comprising PETG (polyethylene terephthalate glycol), PLA (polylactic acid).

5. The device (2) according to anyone of the preceding claims, wherein said reinforcing elements (201 , 202, 20T, 202’) define an overall gripper configuration, said common central pressing element (200) defining a shaped cavity between side margins (111 , 112) of said gripper configuration.

6. The device (2) according to anyone of the preceding claims, wherein said reinforcing elements (201 , 202, 20T, 202’) each have a substantially“U”- or“V”- shape in cross-section and wherein external branches (111 , 112) of each of said “U” or“V” conformations exert said transverse action of approaching the edges of the lesion.

7. The device (2) according to anyone of the preceding claims, wherein said reinforcing elements (201 , 202, 20T, 202’) and said common central pressing element (200) define an overall“M” conformation in cross-section.

8. The device (2) according to anyone of the preceding claims, wherein said flexible arms (203, 204, 203’, 204’) each have a substantially arched conformation to wrap the body district affected by the cutaneous lesion.

9. The device (2) according to anyone of the preceding claims, comprising traction means (105) of said flexible arms (203, 204, 203’, 204’), configured to exert a pulling action at said free ends (113, 114) of said flexible arms (203, 204, 203’, 204’).

10. The device (2) according to the previous claim, wherein said traction means (105) comprises a pair of pulling elements (501 , 502), each associated with a respective flexible arm (203, 204, 203’, 204’).

11. The device (1 ) according to claim 9 or 10, wherein said traction means (105) comprises a tensioning element (503), in particular in form of a roller, of said flexible arms (203, 204, 203’, 204’).

12. The device (1 ) according to anyone of the preceding claims, comprising a covering sheath or gauze of an internal surface of at least said central pressing element (100).