FR3050373A1 - AESTHETIC TREATMENT DEVICE COMPRISING A TENSILE THREAD - Google Patents

Abstract

The invention relates to a device (1) for aesthetic treatment comprising a tensor wire (2) intended to be inserted under the skin of a patient, each end of said wire being equipped with a rod (5) for guiding the thread under the skin on an insertion stroke, each stem (5) having a rounded distal end (5a) which is arranged to preserve the subcutaneous tissue on the insertion stroke of the tensioning thread (2).

Description

The invention relates to a device for aesthetic treatment comprising a tensioning wire intended to be inserted under the skin of a patient, and a kit comprising at least one such aesthetic treatment device and a device for its insertion under the skin of the patient. .

It applies in particular to tensor threads intended to be inserted under the skin of at least a part of the body of a patient, for example the face or the neck, possibly in addition to an injection of a filling product and / or based on botulinum toxin, in order to temporarily eliminate the effects considered unsightly aging skin, such as wrinkles and loosening of the skin.

In general, these tensor threads can stimulate the natural production of collagen by the subcutaneous tissue, and this during the months following their insertion, in order to provide progressive and natural results. In addition, some of the yarns may have elements distributed over at least a part of their length, in particular in the form of notches or cones attached to said yarn, said elements being intended to engage with the subcutaneous tissue during the treatment. insertion of said wire under the skin of the patient, in order to provide a maintenance of said tissue, and thus a correction of the unsightly effects, as soon as said insertion.

To allow its insertion, each end of a tensioning thread is provided with a needle for guiding said thread under the skin over an insertion stroke, said needle being provided with a sharp distal end to allow the piercing of the skin at the beginning and / or at the end of said stroke, so as to respectively allow entry and / or exit of said needle from said skin.

During the procedure, the practitioner begins by piercing with the needle a skin area located not far from an area to be treated, to provide access to said area to be treated. Then, the practitioner introduced by the access hole thus formed the body of the needle and slides under the skin to guide the tensioning wire of said device on its insertion stroke. Finally, once at the end of the insertion stroke of the wire, the practitioner pierces an exit hole in the skin by means of the sharp distal end of the needle, in order to extract said needle through said hole. exit.

However, this solution is not entirely satisfactory, in that the distal end of the needle, because of its sharpness, can damage the subcutaneous tissue and / or the possible blood vessels on the thread insertion stroke tensor, which can cause bruising, bruising or edema, and thus lengthen the patient's recovery time. The invention aims to improve the prior art by proposing in particular a device for aesthetic treatment which is arranged to allow the practitioner to easily and quickly perform the insertion of a tensor wire under the skin of a patient, and this while significantly reducing the risk of subcutaneous trauma for said patient. For this purpose, according to a first aspect, the invention proposes a device for aesthetic treatment comprising a tensioning wire intended to be inserted under the skin of a patient, each end of said wire being equipped with a rod intended to guide the wire under the skin on an insertion stroke, each stem having a rounded distal end which is arranged to preserve the subcutaneous tissue on the tensor thread insertion stroke.

According to a second aspect, the invention proposes a kit comprising at least one such aesthetic treatment device, as well as a device for the insertion of said cosmetic treatment device under the skin of a patient, said insertion device comprising a central body equipped with a gutter which extends in a sagittal plane by having a sharp distal tip projecting from a distal end of said body for piercing said skin, said channel being arranged to allow sliding on it of a rod beyond said distal tip under said skin. Other features and advantages of the invention will appear in the description which follows, with reference to the appended figures, in which: - Figure 1 shows a device for aesthetic treatment according to one embodiment of the invention; FIGS. 2a and 2b show a device that can be used in a kit with the aesthetic treatment device of FIG. 1 in order to allow the insertion of the aesthetic treatment device under the skin of a patient, respectively in front perspective (FIG. 2a). and in plan view (Figure 2b).

In connection with these figures, an aesthetic treatment device 1 comprising a tensioning thread 2 intended to be inserted under the skin of a patient is described below, as well as a kit comprising at least one such device 1 for aesthetic treatment and a device 3 for its insertion under the skin of the patient.

The area to be treated may be located on the patient's face or neck, particularly on the parts of the face or neck most susceptible to unsightly skin aging effects, such as wrinkles, sagging and / or loss of skin. volume. For example, the area to be treated may be located at the level of the lower jaw, a lower eyelid, a cheekbone, a cheek, a jowl, a nasolabial fold, the commissure of lips, glabella, or an eyebrow.

The area to be treated can also be located on other parts of the body particularly prone to such aging effects, as the hands, but also the arms, thighs, chest for women, especially at the neckline, the leather hairy, belly, or feet. In particular, the area to be treated may be located in the stratum granulosum, that is to say the last layer of nucleated cells of the epidermis.

Before proceeding to the intervention, the practitioner can determine the zones to be treated by a careful examination of the patient, in particular by means of adapted lighting, to identify the possible lack of volume and the asymmetries which can result from it, but also for identify the blood vessels that should be avoided so as not to cause trauma to the patient.

This examination includes local observations but also a global observation, especially with regard to the face, in order to correct the unsightly effects in a harmonious way and thus to guarantee a natural result for the patient. Once the areas to be treated have been identified, the practitioner can mark them with a hypoallergenic pencil, and in particular, for each of said zones, the entry and exit points of the treatment device (s) 1 to be inserted. and / or the direction (s) of the insertion stroke (s) of its tensor wire (s) 2.

Moreover, to limit the risk of infection, the practitioner must obviously take hygiene measures, especially before proceeding to the marking of the areas to be treated. To do this, the practitioner can clean the skin to remove any impurities, including makeup, and apply an antiseptic solution on said skin.

Advantageously, the tensor yarn 2 is made of a resorbable material, especially selected from polylactic acid and / or polydioxanone. Alternatively, the tensioning wire 2 may also be made of a non-absorbable material, especially selected from polypropylene, polyester and / or nylon. As soon as it is inserted into the subcutaneous tissue, the tensor yarn 2 causes a healing reaction, which induces a production of new collagen around and in the vicinity of said yarn which extends over the months following said insertion, and thus makes it possible to correct the unsightly effects of skin aging gradually and naturally.

Moreover, the tensor wire 2 can have elements 4a, 4b distributed over at least part of its length and intended to engage with the subcutaneous tissue during the insertion of said thread under the skin of the patient, in order to to provide a maintenance of said tissue, and therefore a correction of the unsightly effects targeted, as soon as said insertion.

In the embodiment shown, the subcutaneous elements 4a, 4b comprise cones attached to the wire, each cone providing a holding effect in the direction Da, Db extending from its top 5 to its base 6. In particular, the tensioning wire 2 of FIG. 1 has two series of cones 4a, 4b distributed on each of its halves 2a, 2b and oriented in opposite directions Da, Db, which allows said wire to provide bidirectional support.

The subcutaneous elements 4a, 4b can be made based on a resorbable material, especially selected from polylactic acid and / or glycolic acid, or based on a non-absorbable material, in particular polypropylene.

To allow its insertion under the skin of the patient, each end of the tensioning wire 2 is provided with a rod 5 for guiding said wire under the skin on an insertion stroke. In particular, the rod 5 may be in the form of a cannula conventionally used in the aesthetic field, in particular having a central duct which communicates with a lateral orifice formed in its distal end. Alternatively, the rod 5 may be solid or at least devoid of lateral orifice since it has no injection function.

The rods 5 may be at least partially made of stainless steel, in particular alloy SUS 304 or alloy AISI 304 (crude chemical formula FeCr-ieNiio), the latter being particularly remarkable for its good performance in terms of flexibility, robustness, elasticity, corrosion resistance and tolerance by the patient's body, and / or a shape-memory alloy.

In addition, the outer surface of each rod 5 may have undergone a special treatment, for example based on silicone, to facilitate the sliding of said rod under the skin of the patient, and thus to minimize the trauma for said patient, in particular the hematomas, bruises or edema. In addition, in the case of using a cannulated stem, the side port may have been treated to have the least amount of sliding interference.

Depending on the length and / or depth of the area to be treated, the dimensions of the tensor wire 2 and / or the rods 5 may vary. In particular, for an area to be treated to locate on the face or neck, at least one rod 5 may have an outer caliber of about 22G and / or a length of about 12 cm. In addition, if the tensioning wire 2 comprises subcutaneous gripping elements 4a, 4b, the rods 5 may have an outer diameter greater than or equal to a maximum radial dimension of said elements, for example the diameter of their base 6 if it It acts of cones, to facilitate their insertion under the skin of the patient.

The rods 5 are advantageously flexible in order to facilitate their movement on the insertion stroke of the tensor yarn 2. In particular, the flexibility of a rod 5 is linked to its outer caliber, and is all the more important that said caliber external is weak.

In addition, each rod 5 has a rounded distal end 5a which is arranged to preserve the subcutaneous tissue, or even the possible blood vessels that extend over the insertion stroke of the tensor wire, in order to limit the trauma for the patient, in particular the formation of bruises, bruises and / or edemas, and thus to reduce the convalescence time of said patient.

In order to be able to introduce such a rod 5 under the skin of the patient, and thus to insert the tensioning wire 2, the practitioner must drill a zone of said skin in order to provide for said rod an access hole under said skin.

To do this, it is known to use a standard injection needle provided with a plastic base normally arranged to allow the mounting of said needle on the tip of a syringe, and to achieve the piercing of the skin. grasping said base with two fingers, which constitutes a diverted use of said needle.

In particular, once the pierced skin, the practitioner removes the needle and introduced through the access hole thus formed a rod 5 of the tensioning wire 2 to be inserted, and then slides said rod under the skin, to guide the tensor wire 2 on his insertion stroke.

However, this type of technique is not entirely satisfactory, in that it requires use in two distinct times, insofar as the practitioner must first completely remove the needle from the skin before the rod can be inserted. In particular, the successive inputs and outputs of the needle and the stem 5 cause trauma to the cutaneous tissues.

In addition, the hole formed by the piercing needle is sometimes difficult to identify, in particular because the practitioner must remove the needle and put it on a sterile surface before entering the device 1 for aesthetic treatment to be inserted, and leaves of this is momentarily the pierced area of the eyes. Thus, the practitioner can waste time trying to locate the hole.

In particular, to locate the hole, the practitioner may be forced to pinch the skin, sometimes several times, so as to cause bleeding through said hole, which can be painful for the patient and cause haematomas or swelling from the pinched area to bleeding. As a result, the recovery of the patient is lengthened, and the presence of unsightly traces may present a prejudice for the patient, then forced to a temporary social eviction during said recovery.

Moreover, such a technique requires many manipulations of the piercing needle, in particular to insert and remove it from the skin of the patient, which increases the risk of accidental punctures for the practitioner as well as the risk of loss of sterility. of said needle, the risk of accidental punctures being all the more increased that the manipulation of said needle lack of ergonomics, insofar as said needle is not specially adapted for such use.

To overcome these drawbacks, the kit comprises a device 3 for insertion under the skin of the patient of the device 1 for aesthetic treatment, said device comprising a central body 7 equipped with a channel 8 which extends along a sagittal plane S having a sharp distal tip 8a protruding from a distal end 7a of said body for piercing the skin, said channel being arranged to allow sliding on it of a rod 5 beyond its distal tip 8a under the skin of the patient.

In particular, the channel 8 has an internal dimension which is greater than the outer caliber of the rod 5 to slide on it. In addition, if the tensor wire 2 comprises subcutaneous grip elements 4a, 4b, the groove 8 may have an external dimension greater than or equal to a maximum radial dimension of said elements, for example the diameter of their base 6 if it is cones, to provide an access hole of diameter greater than said maximum radial dimension, and thus to allow their insertion under the skin of the patient.

Advantageously, the insertion device 3 is of the type described in document FR-3,024,366, and shown in FIG. 2, that is to say with a central body 7 provided with two lateral arms 9. which extend symmetrically on either side of the sagittal plane S in a transverse direction DT which forms with said sagittal plane an angle α of between 30 ° and 85 °, each gripping arm 9 further having a surface 10 digital holding device which has a front central portion 11 located at a distance d between 8 mm and 30 mm from the distal end 7a of the central body 7.

In particular, the insertion device 3 may have all the technical features presented in the document FR-3024366, in particular with respect to the various dimensions, arrangements and / or angular positions of its central body 7 and / or of its gripping arms. 9.

The area to be pierced may in particular be located on the patient's face, for example near an ear (retro-mandibular point), in a nasolabial area (at the level of the modiolus, naso-genital point), at the level of the zygomatic bone (zygomatic point), on a temple (temporal or frontal point) or above the glabella (glabellar point).

The zone to be pierced may also be located on any other part of the patient's body, in particular on a hand, an arm or a thigh, on the chest, in particular at the level of the cleavage, on the scalp, on the stomach, or on a foot.

To pierce the skin of the patient, the practitioner, after having prepared said skin, grasps the insertion device 3 with his fingers and inserts the sharp distal tip 8a into said skin. Then, once the skin of the pierced patient, the practitioner has a rod 5 of a device 1 for aesthetic treatment on the trough 8, the sharp tip 8a of the insertion device 3 remaining planted in the skin, then slides said rod beyond said sharp distal tip, to introduce the rounded distal end 5a under said skin.

Thus, the practitioner can save time compared to conventional insertion techniques, because he does not have to locate the hole formed by drilling, since the insertion device 3 having served at said piercing remains positioned in said hole and that the access to the area to be treated is materialized by the gutter 2, which is easily localizable. Therefore, the practitioner does not need to resort to traumatic practices for the patient, such as pinching the skin of said patient several times to locate the hole by risking bleeding.

In addition, by guiding the rod 5 by the trough 8, the practitioner fumbles less during the introduction of said rod, which is also less traumatic for the patient.

In addition, the handling operations of the insertion device 3 are limited, which limits the risk of accidental puncture for the practitioner and the risk of loss of sterility of the sharp tip 8a of said device.

Once the rod 5 has been inserted under the skin, the practitioner removes the insertion device 3 in order to extract its pointed tip 8a from said skin, while leaving the stem 5 inserted under the said skin. In particular, the practitioner can remove the insertion device 3 by sliding the channel 8 relative to the rod 5 introduced under the skin.

After removing the insertion device 3, the practitioner has both hands to insert the tensor wire 2, in particular by sliding the rod 5 under the skin until it out through a hole in the skin at the end of 2. Advantageously, the outlet hole may also be produced by means of the device 3, in particular by providing for introducing its pointed tip 8a opposite the distal end 5a disposed under the skin to allow the exit of the rod 5 by sliding on the gutter 8.

To facilitate its positioning on the insertion stroke of the tensor wire 2, at least one rod 5 may have a marking 12 which is spaced from its distal end 5a at a distance of about 5 mm, which corresponds on average to the value the distance between the surface of the epidermis and the surface of the hypodermis. Thus, during the insertion of the tensioning thread 2, the practitioner can, by means of the marking 12, locate approximately the position of the hypodermis, and thus orient the rod 5 approximately tangentially to said hypoderm, in order to slide the along said hypodermis to insert the tensioning wire 2.

To limit the pain felt by the patient during the procedure, the practitioner may, prior to piercing the skin, apply an anesthetic product at least on and / or in the area to be pierced, which makes it possible to limit both the pain due to said piercing and the pain due to the introduction of the rod 5. In particular, the anesthetic product can be applied locally in the form of a cream and / or patch, for example an Emla®-type patch, or by injection.

Furthermore, the practitioner may plan to treat successively several areas, and this by accessing from the same access hole. In particular, the practitioner can treat two areas by means of the same device 1 of aesthetic treatment, and this by inserting each of the two halves 2a, 2b of the tensor wire 2 of said device on respectively one of said zones.

To do this, the practitioner may, in a first step, insert a first half 2a, 2b of the tensor yarn 2 of the same device 1 of aesthetic treatment in a first zone, and this by means of the rod 5 to which the free end of said first half is secured, said rod being introduced under said skin by means of the insertion device 3.

Then, once the first half 2a, 2b of the tensor wire 2 in place, the practitioner can insert the second half 2b, 2a of said wire by introducing the second rod 5 through the access hole formed by means of the insertion device 5 which is easily localizable thanks to the portion of tensor yarn 2 coming out of it, then sliding this second rod 5 into a second zone which is offset with respect to the first zone, in order to insert said second half into said second zone .

Once all the areas have been treated by insertion of one or more devices 1, the practitioner may optionally carry out additional treatment steps, in particular injection of a filling product, for example based on hyaluronic acid, or a botulinum toxin product, depending on the type and / or the importance of the unsightly effects to be corrected.

Advantageously, the kit may comprise several aesthetic treatment devices 1 which have rods 5 of identical calibers and possibly tensor son 2 of different lengths, in order to allow the practitioner to treat several areas more or less distant from the patient's skin. with a single kit, in particular by inserting each of said treatment devices in different areas by means of the same insertion device 3 contained in said kit.

The different treatment devices 1 and insertion 3 of the same kit can be packaged in the same transparent sterile bag, in particular based on polypropylene and / or polyethylene, said bag can also be flexible or rigid and / or understand at least one portion based on peelable paper.

Furthermore, the kit thus packaged can be stored in a box containing other kits also packaged in bags, in order to be protected from moisture and light during storage.

In particular, the central body 7 of the insertion device 3 may have a coloration corresponding to the outer caliber of the rods 5 of the treatment devices 1, which allows the practitioner to identify, among several kits packaged in bags, the kit which he just needs looking at the color of the central body.

The aesthetic treatment devices 1 may also be packaged alone, especially in bags as described above, in order to be marketed alone, in particular for sale to laboratories.

Furthermore, after the packetization, the treatment device 1 or the kit are sterilized, for example by means of a process of sterilization by ethylene oxide (ETO), ionizing radiation or vapor.

In addition, the sachet may include indications for the practitioner, such as a lot number, the dimensions of the stem 5 and / or the tensor wire (s) 2, a notion restricting the use to qualified practitioners, a reference to the notified body and / or a mark of conformity to a standard, in particular the CE standard.

In particular, the sachet may comprise information useful for the safe use of the cosmetic treatment device 1 or the kit it contains, for example a sterilization date and / or an expiry date. Furthermore, if the bag has a poor condition and / or an opening, the practitioner can know immediately that the device 1 of aesthetic treatment or the kit contained in said bag must be destroyed for the safety of the patient.

Claims (11)

1. Device (1) for aesthetic treatment comprising a tensor wire (2) intended to be inserted under the skin of a patient, each end of said wire being equipped with a rod (5) for guiding the wire under the skin on an insertion stroke, said device being characterized in that each rod (5) has a rounded distal end (5a) which is arranged to preserve the subcutaneous tissue on the insertion stroke of the tensioning thread (2). 2. Device (1) according to claim 1, characterized in that the tensor wire (2) is made of a resorbable material, especially selected from polylactic acid and / or polydioxanone. 3. Device (1) according to claim 1, characterized in that the tensor wire (2) is made of a non-absorbable material, especially selected from polypropylene, polyester and / or nylon. 4. Device (1) according to any one of claims 1 to 3, characterized in that the tensor wire (2) has elements (4a, 4b) intended to engage with the subcutaneous tissue during the inserting said wire under the skin of the patient, said elements being distributed over at least a part of the length of said wire. 5. Device (1) according to claim 4, characterized in that the elements (4a, 4b) subcutaneous comprise cones reported on the wire. 6. Device (1) according to one of claims 4 or 5, characterized in that the elements (4a, 4b) subcutaneous are made of a material selected from polylactic acid, the acid glycolic and / or polypropylene. 7. Device (1) according to any one of claims 1 to 6, characterized in that at least one rod (5) has an outer caliber of about 22G. 8. Device (1) according to any one of claims 1 to 7, characterized in that at least one rod (5) has a length of about 12 cm. 9. Device (1) according to any one of claims 1 to 8, characterized in that at least one rod (5) has a marking (12) which is spaced from the distal end (5a) at a distance d about 5 mm. 10. Kit comprising at least one device (1) for aesthetic treatment according to any one of claims 1 to 9, and a device (3) for the insertion of said cosmetic treatment device under the skin of a patient, said insertion device comprising a central body (7) provided with a gutter (8) which extends in a sagittal plane (S) with a sharp distal tip (8a) projecting from a distal end (7a) of said body for piercing said skin, said channel being arranged to allow sliding on it of a rod (5) beyond said distal tip under said skin. 11. Kit according to claim 10, characterized in that the central body (7) is provided with two lateral arms (9) for gripping which extend symmetrically on either side of the sagittal plane (S) in a transverse direction (DT) which forms with said sagittal plane an angle (a) of between 30 ° and 85 °, each gripping arm (9) further having a digital holding surface (10) having a front central portion (11) located at a distance (d) between 8 mm and 30 mm from the distal end (7a) of the central body (7).