WO2015015127A2 - Method for injecting a product as part of an aesthetic intervention - Google Patents

Method for injecting a product as part of an aesthetic intervention Download PDF

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Publication number
WO2015015127A2
WO2015015127A2 PCT/FR2014/052000 FR2014052000W WO2015015127A2 WO 2015015127 A2 WO2015015127 A2 WO 2015015127A2 FR 2014052000 W FR2014052000 W FR 2014052000W WO 2015015127 A2 WO2015015127 A2 WO 2015015127A2
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WO
WIPO (PCT)
Prior art keywords
injection
cannula
needle
treated
product
Prior art date
Application number
PCT/FR2014/052000
Other languages
French (fr)
Other versions
WO2015015127A3 (en
Inventor
Sandrine SEBBAN
Original Assignee
Soft Medical Aesthetics
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Soft Medical Aesthetics filed Critical Soft Medical Aesthetics
Priority to EP14790167.2A priority Critical patent/EP3027261A2/en
Publication of WO2015015127A2 publication Critical patent/WO2015015127A2/en
Publication of WO2015015127A3 publication Critical patent/WO2015015127A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like
    • A61M25/065Guide needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00792Plastic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M2005/3201Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0008Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287Accessories for bringing the needle into the body; Automatic needle insertion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A61M5/3291Shafts with additional lateral openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • the invention relates to a method of injecting a product in the context of an aesthetic intervention, and an injection kit especially for the implementation of such a method.
  • a filling product in particular based on hyaluronic acid
  • a filling product under the skin of at least a part of the body of a patient, for example the face and / or neck of said patient , in order to temporarily remove the unsightly effects of aging of the skin, such as wrinkles and loosening of the skin, and / or to revitalize said skin by moisturizing the layers of the epidermis.
  • autologous autologous pre-patient autologous injections such as platelet-rich plasma (PRP), for example for fibroblastic and collagenic stimulation of the skin to correct the unsightly effects due to aging, or fat, for example to correct the loss of volume of the skin due to trauma such as an accident or surgery.
  • PRP platelet-rich plasma
  • an injection cannula which has a rounded distal end and at least one lateral injection port disposed near said distal end.
  • this type of cannula is particularly suitable for fillers, which are generally quite thick, and minimizes trauma to tissues and vessels deep layers of the skin, such as bruising, bruising or edema, as well as nervous trauma.
  • the practitioner begins by piercing, with a needle having a sharp distal end, an area of the skin located not far from an area to be treated, to provide access to said area to be treated. Then, the practitioner removes the piercing needle and introduced through the hole thus formed an injection cannula as described above, then slides under the skin said cannula until the injection port opens into the area treat. It then injects the product into the area to be treated via the cannula, the product being for example contained in a syringe or in another type of container on which the said cannula is mounted.
  • 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.
  • bleeding through said hole can be painful for the patient and cause haematomas or swelling from the pinched area to bleeding.
  • the patient's recovery is lengthened, and the presence of unsightly traces can be harmful to the patient, who is then forced to temporary eviction during the convalescence.
  • the invention aims to improve the prior art by proposing in particular an injection method allowing the practitioner to more easily and quickly perform the injection of a product, while significantly reducing the risk of trauma to the patient.
  • the invention proposes a method of injecting a product in the context of an aesthetic intervention, said method providing the following successive steps of: piercing an area of the skin of a patient by means of a needle having a sharp distal end, said needle comprising a bore which extends between an upstream opening and a downstream opening opening into said distal end;
  • an injection cannula which has at least one injection orifice
  • the invention proposes a kit for injecting a product, particularly in the context of an aesthetic intervention, said kit comprising:
  • At least one injection cannula which has at least one injection orifice
  • At least one piercing needle of the skin of a patient which has a sharp distal end, and a bore extending between an upstream opening and a downstream opening which opens into said distal end, said bore being arranged to allow sliding the injection cannula beyond the distal end to at least one area to be treated under the skin.
  • FIG. 1 represents an injection cannula according to one embodiment of the invention, FIG. 1a showing an enlarged view of zone A of FIG. 1;
  • FIG. 2 shows two injection kits according to one embodiment of the invention, respectively;
  • FIG. 3 represents an injection kit according to the invention, in which the injection cannula is introduced partially into the bore of the piercing needle;
  • Figure 4 shows schematically in longitudinal section an injection cannula;
  • FIG. 5 shows schematically in semi-longitudinal section a needle.
  • injection kit especially for the implementation of such a method.
  • the kit may also be used for the injection of a biocompatible product in the context of a medical or veterinary intervention, said product containing for example primarily anesthetic.
  • the injection kit may be a single-use medical device for use by qualified personnel, including medical or paramedical personnel.
  • the product to be injected may be a filling product, for example based on hyaluronic acid, to temporarily correct the unsightly effects of aging of the skin.
  • a product based on hyaluronic acid fluid can be used to smooth the skin to reduce wrinkles.
  • a product based on crosslinked hyaluronic acid therefore thicker, can be used to restore volume to the skin and / or to stretch said skin, in order to counterbalance a relaxation due to a loss of elasticity of said skin and / or to correct an asymmetry, in the case where an area of the skin has a loosening and / or loss of volume greater than its symmetrical zone.
  • the product to be injected may also comprise an additive having anesthetic properties, for example based on lidocaine, in order to reduce the pain that the patient may feel during the injection, this pain being all the more important that the said product is thick.
  • the product to be injected may also comprise an additive having antioxidant properties, for example base of mannitol, as well as vitamins to revitalize the layers of the skin in the area to be treated.
  • the product to be injected may also be an autologous organic product previously taken from the patient, such as, for example, fat or platelet-rich plasma (PRP), for purely cosmetic purposes and / or to allow injections in auto-transplant, in particular to correct unsightly effects due to trauma such as an accident or surgery.
  • an autologous organic product previously taken from the patient, such as, for example, fat or platelet-rich plasma (PRP), for purely cosmetic purposes and / or to allow injections in auto-transplant, in particular to correct unsightly effects due to trauma such as an accident or surgery.
  • PRP platelet-rich plasma
  • the area to be treated can be located on the face or neck of the patient, especially on the parts of the face or neck most prone to unsightly effects of aging of the skin, such as wrinkles or loosening.
  • the area to be treated may be located at a commissure of the lips (subject to "folds of bitterness"), at an outer corner of an eye (subject to wrinkles in "crow's feet"), on a temple , on the forehead, and especially at the level of the glabella (subject to "lion's wrinkles”), at an orbital zone (where dark circles and / or pockets may appear), the valley of tears (located under one eye) of a cheekbone or cheek (where looseness and / or loss of skin volume can be seen).
  • 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.
  • the area to be treated may be located at various depths of the patient's skin.
  • the area to be treated is generally located in a superficial layer of the skin, especially the epidermis or dermis.
  • the area to be treated is rather located in a deep layer of the skin, especially the hypodermis.
  • 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.
  • the area to be treated may also be located under the epidermis, in particular between the dermis and the bone, and more particularly between the deep dermis and the periosteum of the bone.
  • 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.
  • the practitioner can mark them with a hypoallergenic pencil.
  • 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.
  • the method provides a first step of piercing an area of the skin of the patient by means of a needle 1 having a sharp distal end 1a, to provide an access hole to the area to be treated.
  • the injection kit comprises at least one such needle 1, said needle having a bore which extends between an upstream opening and a downstream opening which opens into the sharp distal end 1a.
  • the needle 1 is made of stainless steel, for example SUS 304 alloy or AISI 304 alloy.
  • the needle 1 comprises a base 2 on which its proximal end 1b, in which the upstream opening is formed, is mounted, the practitioner using said base to manipulate said needle.
  • the proximal end 1b can be fixed by means of an adhesive in a housing provided for this purpose on the base.
  • the needle 1 can be mounted retractable on the base 2, in particular to be retracted into said base after piercing the skin of the patient.
  • the needle 1 also comprises a protection cap 8 intended to be mounted on the base 2 by covering said needle, in order to protect the practitioner from accidental punctures and possibly to ensure perfect sterility of said needle. needle before use.
  • the base 2 and the cap 8 may be made of a polymer that is harmless to the human body, for example polypropylene or a copolymer based on polypropylene, such as ethylene-polypropylene.
  • the base 2 and the cap 8 may be made of a non-flammable material, in particular without pyrogen.
  • the method is implemented with a standard injection needle 1 provided with a plastic base 2 normally arranged to allow the mounting of said needle on the tip of a syringe, the drilling of the skin being made by grasping said base with two fingers.
  • the needle 1 may be modified, for example by being cut longitudinally to form a gutter on which the bore extends between an upstream opening and a downstream opening which opens into the sharp distal end 1a.
  • the needle 1 has a hemicylindrical geometry, the upstream opening being able to be arranged at the level of the proximal end 1b or along said needle.
  • the base 2 may also be modified to facilitate manual gripping of the needle 1 during piercing of the skin, for example by providing that said base has two lateral gripping arms which extend from both sides. other of said needle.
  • 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 practitioner can reach several localized treatment areas on the face and / or the neck of the patient from the same hole in said area to be pierced, which limits the drilling of the skin, and thus the trauma for the patient.
  • the number of zones to be pierced can be between one and five for each side of said face.
  • 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.
  • the method provides for the use of an injection cannula 3 having at least one injection port 4.
  • the cannula 3 has a rounded distal end 3a, which makes it possible not only to avoid the blood vessels and nerve trauma during the introduction of the cannula 3 under the skin of the patient, and thus to limit trauma for said patient, but also to limit the risk of accidental puncture for the practitioner.
  • the injection kit comprises at least one such cannula 3, said cannula further having at least one injection port 4 disposed laterally near the distal end 3a.
  • the orifice 4 has a diameter between 0.05 mm and 1 mm and is located about 2 mm from the rounded distal end 3a.
  • the method provides a step following the piercing of the skin in which the needle 1 remains planted in the skin, the cannula 3 being introduced into the bore of said needle through its upstream opening.
  • the method provides for a subsequent step of sliding the cannula 3 beyond the distal end 1a of the needle 1, until the orifice 4 opens into the zone treat.
  • the bore of the needle 1 is arranged to allow the sliding of the cannula 3 beyond its distal end 1a to the area to be treated.
  • the bore has a diameter greater than or equal to the outer diameter of the cannula 3, or substantially equal to said outer caliber.
  • the upstream opening of the bore may be arranged to facilitate the insertion of the cannula 3 into the bore, and the base 2 of the needle 1 is wide enough to facilitate the introduction of the cannula 3 in the upstream opening and the bore.
  • the practitioner can save time compared to conventional injection techniques because he does not have to locate the hole formed by the needle 1, since it remains positioned in said hole and that access to the zone to be treated is materialized by the upstream opening of the bore, 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.
  • the method then provides a step of injecting the product into the area to be treated via the cannula 3.
  • the product is injected by means of a syringe or other type of container. on which the cannula 3 is mounted.
  • the cannula 3 has a base 5 on which the proximal end 3b of said cannula is mounted, for example by being fixed by means of an adhesive in a housing provided for this purpose on said base, said base being intended to be mounted on a tip of a syringe containing the product to be injected.
  • the base 5 can be of Luer-Lock® or Luer-Slip® type, to be mounted respectively by screwing or by friction on the tip of the syringe, these types being advantageously universal to allow the use of the cannula 3 with all types of syringes or other containers.
  • the base 5 of the cannula 3 is arranged to fit into the base 2 of the needle 1 at the end of the sliding of said cannula into the bore, which ensures the practitioner stability of the positioning of the the cannula 3 before proceeding to the injection.
  • the cannula 3 also comprises a protective cap 9 to be mounted on the base 5 surrounding said cannula, to ensure the protection and possibly perfect sterility of said cannula before use.
  • the base 5 and the cap 9 may also be made of polypropylene or a polypropylene copolymer, especially ethylene-polypropylene.
  • the base 5 and the cap 9 may be made of a non-flammable material, in particular without pyrogen.
  • the dimensions of the cannula 3 may vary.
  • the cannula 3 may have a reduced internal size if the product is fluid and on the contrary more important if the product is thick.
  • the practitioner can inject a thick product without applying too much pressure to said product, which facilitates said injection and reduce pain for the patient.
  • the molecules of the product are less subject to physical constraints and therefore less likely to be deteriorated.
  • the cannula 3 may have an external gauge between 14G (14 gauges, which corresponds to a diameter of 2 mm) and 33G (0.2 mm), and especially between 22G (0.7 mm) and 25G ( 0.5 mm).
  • the cannula 3 can also be flexible, to facilitate its guidance to the area to be treated, and then the positioning of its injection port 4 in said area to be treated.
  • the flexibility of the cannula 3 is related to the outer caliber, said flexibility being all the more important that said outer caliber is reduced.
  • the cannula 3 may be at least partially made of stainless steel, in particular alloy SUS 304 or alloy AISI 304 (crude chemical formula FeCnsNi-10), the latter being particularly remarkable for its good performance in terms of flexibility, robustness, elasticity and resistance to corrosion, and / or a shape memory alloy.
  • the outer surface of the cannula 3 may have undergone a special treatment, for example based on silicone, in order to facilitate the sliding of said cannula under the skin of the patient, and thus to minimize the trauma for said patient, in particular the hematomas, bruises or edema.
  • a special treatment for example based on silicone
  • the base 5 of said cannula may include an identification marking of its outer caliber and / or its internal caliber.
  • the identification marking consists of a coloration of the base 5, the coloration corresponding to the internal gauge and / or the external gauge of the cannula 3, as defined in particular by the NF EN ISO 6009 standard.
  • the base 2 of the needle 1 has a coloration identical to that of the base 5 of the cannula 3, which identifies said needle and said base as belonging to the same injection kit.
  • the needle 1 and the cannula 3 of the same kit may be packaged in the same transparent sterile bag, in particular based on polypropylene and / or polyethylene, said bag may also be flexible or rigid and / or include at least one portion based on peelable paper.
  • the kit thus packaged can be stored in a box containing other kits also packaged in sachets to be protected from moisture and light during storage, the practitioner identifying at a glance the kit he has need by looking at the coloration of the bases 2, 5.
  • the needle 1 and the cannula 3 of a kit are sterilized, for example by means of a process of sterilization by ethylene oxide (ETO), by ionizing radiation or by steam.
  • the sachet may include indications for the practitioner, such as a lot number, the references of the conformity tests performed and / or the dimensions of the cannula 3 and / or the needle, and in particular information useful for safe use of the kit it contains, for example a date of sterilization and / or an expiry date, a notion restricting the use to qualified practitioners, a reference to the notified body and / or a marking of conformity to a standard, including the CE standard.
  • the bag has a poor condition and / or an opening, the practitioner can know immediately that the kit contained in said bag must be destroyed for the safety of the patient.
  • the cannula 3 may have a variable length, depending on the depth and / or the location of the zone to be treated with said cannula relative to the access hole. This length may especially be between 13 mm and 1 10 mm, and more particularly between 25 mm and 70 mm.
  • the needle 1 has a greater or lesser length depending on the length of the associated cannula 3, to ensure a guide adapted to said length.
  • the length of the needle 1 may in particular be between 4 mm and 30 mm.
  • the cannula 3 may have graduations 6. arranged at regular intervals along its length, for example every centimeter.
  • the base 5 of the cannula 3 may comprise on its periphery a marking 7 for locating the injection orifice 4 which is aligned with said injection orifice, which allows the practitioner to correctly orient said orifice. when it is positioned in the area to be treated.
  • the marking of marking comprises a point 7 formed on the periphery of the base 5, said point being made in a sufficiently bright color to contrast with the color of said base.
  • the marking may have another pattern, in particular in the form of an arrow. It can also be made in relief on the base 5, for example during the molding of said base, and optionally colored with a different shade of said base.
  • the method may provide a step prior to piercing the skin, wherein an anesthetic is applied at least on and / or in the area to be pierced, thereby limiting both the pain due to said piercing and the pain due to the introduction of the cannula 3.
  • the anesthetic product can be applied locally in the form of cream and / or patch, for example an Emla® type patch.
  • the method may provide for successively treating several zones, and this by accessing from the same access hole, which is greatly facilitated by the maintenance of the needle 1 in said hole to guide the cannulas 3
  • the practitioner has to change the cannula 3, in particular to change product or to use a cannula 3 of different length and / or internal gauge, leaving the needle 1 in place makes it easier to inserting new cannulas 3 through said access hole, and thus save time.
  • the same kit may include several cannulas 3 which have for example the same external template, but different internal templates and / or lengths, to allow the practitioner to perform several injections with several products and / or in multiple areas to be treated with one kit.
  • the same kit may also include several needles 1 which have for example different lengths.
  • the practitioner can inject several products in the same area according to the aesthetic effects he wishes to bring to said area.
  • the practitioner can inject several products of the same type which have different viscosities and / or the same product at different depths.
  • the method can provide for moving a cannula 3 already introduced into the bore of the needle 1 to another area to be treated after injection of said product in a first zone.
  • the practitioner may use a retractable mounted needle 1 on its base 2, said needle being retracted into said base after passage of the cannula 3 beyond the end 1a, that is to say after insertion of the cannula 3 under the skin by means of the needle 1.
  • the injection can be performed only with the cannula 3 inserted into the skin, which allows the practitioner to more easily manipulate said cannula and perform an injection less traumatic for the patient.
  • the needle 1 can be retracted before displacement of the cannula 3 to another area to be treated, in order to avoid injuring the patient in the area around the hole. access.
  • the method may provide a radial displacement between the area that has just been treated and a new area to be treated to proceed to a new injection in said new area.
  • the method may provide for repeating at least once such radial displacement from the treated area to another area to be treated and a subsequent step of injecting product into said other area.
  • the practitioner can treat an entire area of the face, for example the forehead, a temple or a cheek, and this from a single access hole.
  • a known technique In order to correct a loosening of the skin which is widely spread over an area of the face, for example on the forehead, on a temple or on a cheek, a known technique consists in injecting the product by bolus, that is to say, depositing several small doses of product on the whole of said zone by making several displacements in said zone, in order to stretch said skin over the whole area while giving it back volume.
  • the practitioner can perform several bolus injections by performing several radial movements, including fan, in the same area.
  • the practitioner can also use a particular technique called “topping" which is usually performed in a layer of the hypodermis, in order to achieve a smoothing surface and plump the skin deep.
  • the practitioner makes sure to perform all the injections of topping in the same layer, and in particular at the same depth in said layer.
  • the method may provide for moving the cannula 3 back during the bolus injection of the product, i.e., in a retrograde motion, to distribute the product over a substantial depth range and / or a wider area, which allows a more harmonious and therefore more natural result.
  • the method may provide for moving the cannula 3 forward, in antegrade motion, during the bolus injection of the product.
  • the practitioner easily removes the cannula 3 through guiding in the bore of the needle 1 and can perform a massage on the treated area, in order to evenly distribute the product and give a more homogeneous appearance and therefore more natural to the correction made. The patient can then see results that are immediately visible and lasting.

Abstract

A method for injecting a product as part of an aesthetic intervention. The invention concerns a method for injecting a product as part of an aesthetic intervention, said method including the following successive steps of: - piercing an area of the skin of a patient by means of a needle (1) having a sharp distal end (1a), said needle comprising a bore that extends between an upstream opening and a downstream opening that opens at said distal end; - inserting, into said bore, via said upstream opening, an injection cannula (3) that has at least one injection port (4); - sliding said injection cannula beyond the distal end (1a) until the injection port (4) opens into an area to be treated located under the skin; - injecting the product into said area to be treated via the injection cannula (3).

Description

Procédé d'injection d'un produit dans le cadre d'une intervention esthétique  Method of injecting a product as part of an aesthetic intervention
L'invention concerne un procédé d'injection d'un produit dans le cadre d'une intervention esthétique, ainsi qu'un kit d'injection notamment pour la mise en œuvre d'un tel procédé. The invention relates to a method of injecting a product in the context of an aesthetic intervention, and an injection kit especially for the implementation of such a method.
Elle s'applique en particulier aux injections d'un produit de comblement, notamment à base d'acide hyaluronique, sous la peau d'au moins une partie du corps d'un patient, par exemple du visage et/ou du cou dudit patient, afin de faire disparaître temporairement les effets jugés inesthétiques du vieillissement de la peau, comme par exemple les rides et le relâchement de la peau, et/ou de revitaliser ladite peau en hydratant les couches de l'épiderme. It applies in particular to the injections of a filling product, in particular based on hyaluronic acid, under the skin of at least a part of the body of a patient, for example the face and / or neck of said patient , in order to temporarily remove the unsightly effects of aging of the skin, such as wrinkles and loosening of the skin, and / or to revitalize said skin by moisturizing the layers of the epidermis.
Elle peut également s'appliquer aux injections en autogreffe de produits organiques autologues préalablement prélevés sur le patient, comme du plasma riche en plaquettes (PRP), par exemple pour une stimulation fibroblastique et collagénique de la peau en vue de corriger les effets inesthétiques dus à son vieillissement, ou encore de la graisse, par exemple pour corriger les pertes de volume de la peau dus à un traumatisme tel qu'un accident ou une opération chirurgicale. It can also be applied to autologous autologous pre-patient autologous injections, such as platelet-rich plasma (PRP), for example for fibroblastic and collagenic stimulation of the skin to correct the unsightly effects due to aging, or fat, for example to correct the loss of volume of the skin due to trauma such as an accident or surgery.
Pour pratiquer une telle intervention, le praticien utilise généralement une canule d'injection qui présente une extrémité distale arrondie et au moins un orifice latéral d'injection disposé à proximité de ladite extrémité distale. En effet, ce type de canule est particulièrement adapté aux produits de comblement, qui sont généralement assez épais, et permet de minimiser les traumatismes sur les tissus et les vaisseaux des couches profondes de la peau, comme les hématomes, les ecchymoses ou les œdèmes, ainsi que les traumatismes nerveux. To perform such an operation, the practitioner generally uses an injection cannula which has a rounded distal end and at least one lateral injection port disposed near said distal end. Indeed, this type of cannula is particularly suitable for fillers, which are generally quite thick, and minimizes trauma to tissues and vessels deep layers of the skin, such as bruising, bruising or edema, as well as nervous trauma.
Durant l'intervention, le praticien commence par percer, avec une aiguille présentant une extrémité distale acérée, une zone de la peau localisée non loin d'une zone à traiter, afin de ménager un accès à ladite zone à traiter. Ensuite, le praticien retire l'aiguille de perçage et introduit par le trou ainsi ménagé une canule d'injection telle que décrite précédemment, puis fait coulisser sous la peau ladite canule jusqu'à ce que l'orifice d'injection débouche dans la zone à traiter. Il injecte ensuite le produit dans la zone à traiter par l'intermédiaire de la canule, le produit étant par exemple contenu dans une seringue ou dans un autre type de contenant sur le(la)quel(le) ladite canule est montée. During the procedure, the practitioner begins by piercing, with a needle having a sharp distal end, an area of the skin located not far from an area to be treated, to provide access to said area to be treated. Then, the practitioner removes the piercing needle and introduced through the hole thus formed an injection cannula as described above, then slides under the skin said cannula until the injection port opens into the area treat. It then injects the product into the area to be treated via the cannula, the product being for example contained in a syringe or in another type of container on which the said cannula is mounted.
Cependant, ce type de technique ne donne pas entière satisfaction, en ce que le trou formé par l'aiguille de perçage est parfois difficile à repérer, ce qui peut faire perdre du temps au praticien. However, this type of technique is not entirely satisfactory, in that the hole formed by the piercing needle is sometimes difficult to identify, which can waste time for the practitioner.
En particulier, pour repérer le trou, le praticien peut être contraint de pincer la peau, parfois plusieurs fois, de sorte à provoquer un saignement par ledit trou, ce qui peut s'avérer douloureux pour le patient et générer des hématomes, voire un gonflement de la zone pincée à fin de saignement. De ce fait, la convalescence du patient s'en trouve allongée, et la présence de traces inesthétiques peut présenter un préjudice pour le patient, alors contraint à une éviction sociale temporaire durant ladite convalescence. 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 patient's recovery is lengthened, and the presence of unsightly traces can be harmful to the patient, who is then forced to temporary eviction during the convalescence.
Par ailleurs, une telle technique requiert de nombreuses manipulations de l'aiguille de perçage, notamment pour l'insérer et la retirer de la peau du patient, ce qui augmente le risque de piqûres accidentelles pour le praticien ainsi que le risque de perte de stérilité de ladite aiguille. 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.
L'invention vise à perfectionner l'art antérieur en proposant notamment un procédé d'injection permettant au praticien de réaliser plus facilement et plus rapidement l'injection d'un produit, tout en diminuant de façon importante le risque de traumatismes pour le patient. The invention aims to improve the prior art by proposing in particular an injection method allowing the practitioner to more easily and quickly perform the injection of a product, while significantly reducing the risk of trauma to the patient.
A cet effet, selon un premier aspect, l'invention propose un procédé d'injection d'un produit dans le cadre d'une intervention esthétique, ledit procédé prévoyant les étapes successives suivantes de : - perçage d'une zone de la peau d'un patient au moyen d'une aiguille présentant une extrémité distale acérée, ladite aiguille comprenant un alésage qui s'étend entre une ouverture amont et une ouverture aval débouchant dans ladite extrémité distale ; For this purpose, according to a first aspect, the invention proposes a method of injecting a product in the context of an aesthetic intervention, said method providing the following successive steps of: piercing an area of the skin of a patient by means of a needle having a sharp distal end, said needle comprising a bore which extends between an upstream opening and a downstream opening opening into said distal end;
- introduction dans ledit alésage par ladite ouverture amont d'une canule d'injection qui présente au moins un orifice d'injection ;  introduction into said bore through said upstream opening of an injection cannula which has at least one injection orifice;
- coulissement de ladite canule d'injection au-delà de l'extrémité distale jusqu'à ce que l'orifice d'injection débouche dans une zone à traiter située sous la peau ;  sliding of said injection cannula beyond the distal end until the injection orifice opens into a zone to be treated located under the skin;
- injection du produit dans ladite zone à traiter par l'intermédiaire de la canule d'injection.  injecting the product into said zone to be treated via the injection cannula.
Selon un deuxième aspect, l'invention propose un kit d'injection d'un produit, notamment dans le cadre d'une intervention esthétique, ledit kit comprenant : According to a second aspect, the invention proposes a kit for injecting a product, particularly in the context of an aesthetic intervention, said kit comprising:
- au moins une canule d'injection qui présente au moins un orifice d'injection ;  at least one injection cannula which has at least one injection orifice;
- au moins une aiguille de perçage de la peau d'un patient qui présente une extrémité distale acérée, ainsi qu'un alésage s'étendant entre une ouverture amont et une ouverture aval qui débouche dans ladite extrémité distale, ledit alésage étant agencé pour permettre le coulissement de la canule d'injection au-delà de l'extrémité distale vers au moins une zone à traiter située sous la peau.  at least one piercing needle of the skin of a patient which has a sharp distal end, and a bore extending between an upstream opening and a downstream opening which opens into said distal end, said bore being arranged to allow sliding the injection cannula beyond the distal end to at least one area to be treated under the skin.
D'autres particularités et avantages de l'invention apparaîtront dans la description qui suit, faite en référence aux figures annexées, dans lesquelles : Other features and advantages of the invention will appear in the description which follows, made with reference to the appended figures, in which:
- la figure 1 représente un canule d'injection selon un mode de réalisation de l'invention, la figure 1 a représentant une vue agrandie de la zone A de la figure 1 ;  FIG. 1 represents an injection cannula according to one embodiment of the invention, FIG. 1a showing an enlarged view of zone A of FIG. 1;
- la figure 2 représente deux kits d'injection selon respectivement un mode de réalisation de l'invention ;  FIG. 2 shows two injection kits according to one embodiment of the invention, respectively;
- la figure 3 représente un kit d'injection selon l'invention, dans lequel la canule d'injection est introduite partiellement dans l'alésage de l'aiguille de perçage ; - la figure 4 représente schématiquement en coupe longitudinale une canule d'injection ; FIG. 3 represents an injection kit according to the invention, in which the injection cannula is introduced partially into the bore of the piercing needle; - Figure 4 shows schematically in longitudinal section an injection cannula;
- la figure 5 représente schématiquement en coupe semi-longitudinale une aiguille.  - Figure 5 shows schematically in semi-longitudinal section a needle.
En relation avec ces figures, on décrit ci-dessous un procédé d'injection d'un produit dans le cadre d'une intervention esthétique, notamment dans au moins une zone à traiter située sous la peau d'un patient, ainsi qu'un kit d'injection, notamment pour la mise en œuvre d'un tel procédé. In connection with these figures, a method of injecting a product in the context of an aesthetic procedure, in particular in at least one treatment zone located under the skin of a patient, is described below. injection kit, especially for the implementation of such a method.
Le kit peut également être utilisé pour l'injection d'un produit biocompatible dans le cadre d'une intervention médicale ou vétérinaire, ledit produit contenant par exemple principalement un anesthésiant. En particulier, le kit d'injection peut être un dispositif médical à usage unique destiné à être utilisé par du personnel qualifié, notamment du personnel médical ou paramédical. The kit may also be used for the injection of a biocompatible product in the context of a medical or veterinary intervention, said product containing for example primarily anesthetic. In particular, the injection kit may be a single-use medical device for use by qualified personnel, including medical or paramedical personnel.
Dans le cadre d'une intervention esthétique, le produit à injecter peut être un produit de comblement, par exemple à base d'acide hyaluronique, pour corriger temporairement des effets inesthétiques du vieillissement de la peau. En particulier, un produit à base d'acide hyaluronique fluide peut être employé pour lisser la peau afin d'atténuer les rides. De même, un produit à base d'acide hyaluronique réticulé, donc plus épais, peut être employé pour redonner du volume à la peau et/ou pour étirer ladite peau, afin de contrebalancer un relâchement dû à une perte d'élasticité de ladite peau et/ou de corriger une asymétrie, dans le cas où une zone de la peau présente un relâchement et/ou une perte de volume plus importante que sa zone symétrique. In the context of an aesthetic intervention, the product to be injected may be a filling product, for example based on hyaluronic acid, to temporarily correct the unsightly effects of aging of the skin. In particular, a product based on hyaluronic acid fluid can be used to smooth the skin to reduce wrinkles. Similarly, a product based on crosslinked hyaluronic acid, therefore thicker, can be used to restore volume to the skin and / or to stretch said skin, in order to counterbalance a relaxation due to a loss of elasticity of said skin and / or to correct an asymmetry, in the case where an area of the skin has a loosening and / or loss of volume greater than its symmetrical zone.
Le produit à injecter peut également comprendre un additif présentant des propriétés anesthésiantes, par exemple à base de lidocaïne, afin de diminuer la douleur que peut ressentir le patient durant l'injection, cette douleur étant d'autant plus importante que ledit produit est épais. Le produit à injecter peut aussi comprendre un additif présentant des propriétés antioxydantes, par exemple à base de mannitol, ainsi que des vitamines pour revitaliser les couches de la peau dans la zone à traiter. The product to be injected may also comprise an additive having anesthetic properties, for example based on lidocaine, in order to reduce the pain that the patient may feel during the injection, this pain being all the more important that the said product is thick. The product to be injected may also comprise an additive having antioxidant properties, for example base of mannitol, as well as vitamins to revitalize the layers of the skin in the area to be treated.
Le produit à injecter peut également être un produit organique autologue préalablement prélevé sur le patient, comme par exemple de la graisse ou du plasma riche en plaquettes (PRP), à visée purement esthétique et/ou afin de permettre des injections en auto greffe, notamment pour corriger des effets inesthétiques dus à un traumatisme tel qu'un accident ou une opération chirurgicale. The product to be injected may also be an autologous organic product previously taken from the patient, such as, for example, fat or platelet-rich plasma (PRP), for purely cosmetic purposes and / or to allow injections in auto-transplant, in particular to correct unsightly effects due to trauma such as an accident or surgery.
La zone à traiter peut être localisée sur le visage ou le cou du patient, notamment sur les parties du visage ou du cou les plus sujettes à des effets inesthétiques de vieillissement de la peau, comme les rides ou un relâchement. Par exemple, la zone à traiter peut être localisée à une commissure des lèvres (sujette aux « plis d'amertume »), à un coin externe d'un œil (sujet aux rides en « patte d'oie »), sur une tempe, sur le front, et notamment au niveau de la glabelle (sujette aux « rides du lion »), au niveau d'une zone orbitale (où des cernes et/ou des poches peuvent apparaître), de la vallée des larmes (localisée sous un œil) d'une pommette ou d'une joue (où un relâchement et/ou une perte volume de la peau peut être constaté(e)). The area to be treated can be located on the face or neck of the patient, especially on the parts of the face or neck most prone to unsightly effects of aging of the skin, such as wrinkles or loosening. For example, the area to be treated may be located at a commissure of the lips (subject to "folds of bitterness"), at an outer corner of an eye (subject to wrinkles in "crow's feet"), on a temple , on the forehead, and especially at the level of the glabella (subject to "lion's wrinkles"), at an orbital zone (where dark circles and / or pockets may appear), the valley of tears (located under one eye) of a cheekbone or cheek (where looseness and / or loss of skin volume can be seen).
La zone à traiter peut également être située sur d'autres parties du corps notamment sujettes à de tels effets de vieillissement, comme les mains, mais aussi les bras, les cuisses, la poitrine pour les femmes, notamment au niveau du décolleté, le cuir chevelu, le ventre, ou encore les pieds. 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.
Selon le produit à injecter et l'effet esthétique souhaité, la zone à traiter peut être localisée à des profondeurs diverses de la peau du patient. Par exemple, pour la correction des rides, la zone à traiter est généralement située dans une couche superficielle de la peau, notamment de l'épiderme ou du derme. Au contraire, pour la correction d'un relâchement de la peau, d'un manque de volume, et d'une éventuelle asymétrie résultante, la zone à traiter est plutôt située dans une couche profonde de la peau, notamment de l'hypoderme. Depending on the product to be injected and the desired aesthetic effect, the area to be treated may be located at various depths of the patient's skin. For example, for the correction of wrinkles, the area to be treated is generally located in a superficial layer of the skin, especially the epidermis or dermis. On the contrary, for the correction of a looseness of the skin, a lack of volume, and a possible resulting asymmetry, the area to be treated is rather located in a deep layer of the skin, especially the hypodermis.
En particulier, la zone à traiter peut être située dans le stratum granulosum, c'est- à-dire la dernière couche de cellules nucléées de l'épiderme. La zone à traiter peut également être située sous l'épiderme, notamment entre le derme et l'os, et plus particulièrement entre le derme profond et le périoste de l'os. 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. The area to be treated may also be located under the epidermis, in particular between the dermis and the bone, and more particularly between the deep dermis and the periosteum of the bone.
Avant de procéder à l'intervention, le praticien peut déterminer les zones à traiter par un examen minutieux du patient, notamment au moyen d'un éclairage adapté, pour repérer les éventuels manques de volume et les asymétries qui peuvent en résulter, mais aussi pour repérer les vaisseaux sanguins qu'il conviendra d'éviter pour ne pas créer de traumatismes au patient. Cet examen comprend des observations locales mais aussi une observation globale, notamment s'agissant du visage, afin de corriger les effets inesthétiques de façon harmonieuse et ainsi de garantir un résultat naturel pour le patient. Une fois les zones à traiter identifiées, le praticien peut les marquer au moyen d'un crayon hypoallergénique. 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.
Par ailleurs, pour limiter les risques d'infection, le praticien doit évidemment prendre des mesures d'hygiène, notamment avant de procéder au marquage des zones à traiter. Pour ce faire, le praticien peut nettoyer la peau pour enlever d'éventuelles impuretés, notamment du maquillage, et appliquer une solution antiseptique sur ladite peau. 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.
Le procédé prévoit une première étape de perçage d'une zone de la peau du patient au moyen d'une aiguille 1 présentant une extrémité distale acérée 1 a, afin de ménager un trou d'accès à la zone à traiter. The method provides a first step of piercing an area of the skin of the patient by means of a needle 1 having a sharp distal end 1a, to provide an access hole to the area to be treated.
Pour ce faire, le kit d'injection comprend au moins une telle aiguille 1 , ladite aiguille présentant un alésage qui s'étend entre une ouverture amont et une ouverture aval qui débouche dans l'extrémité distale acérée 1 a. En particulier, l'aiguille 1 est réalisée en acier inoxydable, par exemple en alliage SUS 304 ou en alliage AISI 304. To do this, the injection kit comprises at least one such needle 1, said needle having a bore which extends between an upstream opening and a downstream opening which opens into the sharp distal end 1a. In particular, the needle 1 is made of stainless steel, for example SUS 304 alloy or AISI 304 alloy.
En outre, l'aiguille 1 comprend une embase 2 sur laquelle son extrémité proximale 1 b, dans laquelle est formée l'ouverture amont, est montée, le praticien se servant de ladite embase pour manipuler ladite aiguille. In addition, the needle 1 comprises a base 2 on which its proximal end 1b, in which the upstream opening is formed, is mounted, the practitioner using said base to manipulate said needle.
Par exemple, l'extrémité proximale 1 b peut être fixée au moyen d'un adhésif dans un logement prévu à cet effet sur l'embase. En variante, l'aiguille 1 peut être montée rétractable sur l'embase 2, notamment afin d'être rétractée dans ladite embase après avoir percé la peau du patient. For example, the proximal end 1b can be fixed by means of an adhesive in a housing provided for this purpose on the base. Alternatively, the needle 1 can be mounted retractable on the base 2, in particular to be retracted into said base after piercing the skin of the patient.
En relation avec la figure 5, l'aiguille 1 comprend également un capuchon 8 de protection destiné à être monté sur l'embase 2 en recouvrant ladite aiguille, afin de protéger le praticien de piqûres accidentelles et éventuellement d'assurer une parfaite stérilité de ladite aiguille avant son utilisation. In relation to FIG. 5, the needle 1 also comprises a protection cap 8 intended to be mounted on the base 2 by covering said needle, in order to protect the practitioner from accidental punctures and possibly to ensure perfect sterility of said needle. needle before use.
L'embase 2 et le capuchon 8 peuvent être réalisés en un polymère inoffensif pour le corps humain, par exemple en polypropylène ou en un copolymère à base de polypropylène, comme l'éthylène-polypropylène. De façon générale, l'embase 2 et le capuchon 8 peuvent être réalisés en un matériau ininflammable, notamment dépourvu de pyrogène. The base 2 and the cap 8 may be made of a polymer that is harmless to the human body, for example polypropylene or a copolymer based on polypropylene, such as ethylene-polypropylene. In general, the base 2 and the cap 8 may be made of a non-flammable material, in particular without pyrogen.
Dans le mode de réalisation représenté, le procédé est mis en œuvre avec une aiguille 1 d'injection standard pourvue d'une embase 2 en plastique normalement agencée pour permettre le montage de ladite aiguille sur l'embout d'une seringue, le perçage de la peau étant réalisé en saisissant ladite embase à deux doigts. In the embodiment shown, the method is implemented with a standard injection needle 1 provided with a plastic base 2 normally arranged to allow the mounting of said needle on the tip of a syringe, the drilling of the skin being made by grasping said base with two fingers.
En variante, l'aiguille 1 peut être modifiée, par exemple en étant coupée longitudinalement pour former une gouttière sur laquelle l'alésage s'étend entre une ouverture amont et une ouverture aval qui débouche dans l'extrémité distale acérée 1 a. Selon une réalisation, l'aiguille 1 présente une géométrie hémicylindrique, l'ouverture amont pouvant être disposée au niveau de l'extrémité proximale 1 b ou le long de ladite aiguille. Par ailleurs, l'embase 2 peut également être modifiée pour faciliter la préhension manuelle de l'aiguille 1 lors du perçage de la peau, par exemple en prévoyant que ladite embase présente deux bras latéraux de préhension qui s'étendent de part et d'autre de ladite aiguille. Alternatively, the needle 1 may be modified, for example by being cut longitudinally to form a gutter on which the bore extends between an upstream opening and a downstream opening which opens into the sharp distal end 1a. According to one embodiment, the needle 1 has a hemicylindrical geometry, the upstream opening being able to be arranged at the level of the proximal end 1b or along said needle. Furthermore, the base 2 may also be modified to facilitate manual gripping of the needle 1 during piercing of the skin, for example by providing that said base has two lateral gripping arms which extend from both sides. other of said needle.
La zone à percer peut notamment être localisée sur le visage du patient, par exemple près d'une oreille (point rétro-mandibulaire), dans une zone naso labiale (au niveau du modiolus, point naso-génien), au niveau de l'os zygomatique (point zygomatique), sur une tempe (point temporal ou frontal) ou au dessus de la glabelle (point glabellaire). Ainsi, le praticien peut atteindre plusieurs zones à traiter localisées sur le visage et/ou le cou du patient à partir d'un même trou ménagé dans ladite zone à percer, ce qui permet de limiter les perçages de la peau, et donc les traumatismes pour le patient. En particulier, pour une intervention sur le visage, le nombre de zones à percer peut être compris entre une et cinq pour chaque côté dudit visage. 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). Thus, the practitioner can reach several localized treatment areas on the face and / or the neck of the patient from the same hole in said area to be pierced, which limits the drilling of the skin, and thus the trauma for the patient. In particular, for a procedure on the face, the number of zones to be pierced can be between one and five for each side of said face.
La zone à percer peut être également localisée sur toute autre partie du corps du patient, notamment sur une main, un bras ou une cuisse, sur la poitrine, notamment au niveau du décolleté, sur le cuir chevelu, sur le ventre, ou encore sur un pied. 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.
Pour injecter le produit, le procédé prévoit d'utiliser une canule d'injection 3 présentant au moins un orifice d'injection 4. En particulier, la canule 3 présente une extrémité distale arrondie 3a, qui permet non seulement d'éviter la section de vaisseaux sanguins et des traumatismes nerveux lors de l'introduction de la canule 3 sous la peau du patient, et ainsi de limiter les traumatismes pour ledit patient, mais aussi de limiter le risque de piqûre accidentelle pour le praticien. Pour ce faire, le kit d'injection comprend au moins une telle canule 3, ladite canule présentant en outre au moins un orifice d'injection 4 disposé latéralement à proximité de l'extrémité distale 3a. En particulier, l'orifice 4 présente un diamètre compris entre 0,05 mm et 1 mm et est localisé à environ 2 mm de l'extrémité distale arrondie 3a. To inject the product, the method provides for the use of an injection cannula 3 having at least one injection port 4. In particular, the cannula 3 has a rounded distal end 3a, which makes it possible not only to avoid the blood vessels and nerve trauma during the introduction of the cannula 3 under the skin of the patient, and thus to limit trauma for said patient, but also to limit the risk of accidental puncture for the practitioner. To do this, the injection kit comprises at least one such cannula 3, said cannula further having at least one injection port 4 disposed laterally near the distal end 3a. In particular, the orifice 4 has a diameter between 0.05 mm and 1 mm and is located about 2 mm from the rounded distal end 3a.
Pour atteindre la zone à traiter avec la canule 3, le procédé prévoit une étape suivant le perçage de la peau dans laquelle l'aiguille 1 reste plantée dans la peau, la canule 3 étant introduite dans l'alésage de ladite aiguille par son ouverture amont. Ensuite, en relation avec la figure 3, le procédé prévoit une étape consécutive de coulissement de la canule 3 au-delà de l'extrémité distale 1 a de l'aiguille 1 , jusqu'à ce que l'orifice 4 débouche dans la zone à traiter. To reach the zone to be treated with the cannula 3, the method provides a step following the piercing of the skin in which the needle 1 remains planted in the skin, the cannula 3 being introduced into the bore of said needle through its upstream opening. . Next, with reference to FIG. 3, the method provides for a subsequent step of sliding the cannula 3 beyond the distal end 1a of the needle 1, until the orifice 4 opens into the zone treat.
Pour ce faire, l'alésage de l'aiguille 1 est agencé pour permettre le coulissement de la canule 3 au delà de son extrémité distale 1 a vers la zone à traiter. En particulier, l'alésage présente un diamètre supérieur ou égal au calibre externe de la canule 3, voire sensiblement égal audit calibre externe. En outre, l'ouverture amont de l'alésage peut être agencée pour faciliter l'insertion de la canule 3 dans l'alésage, et l'embase 2 de l'aiguille 1 est assez large pour faciliter l'introduction de la canule 3 dans l'ouverture amont et l'alésage. To do this, the bore of the needle 1 is arranged to allow the sliding of the cannula 3 beyond its distal end 1a to the area to be treated. In particular, the bore has a diameter greater than or equal to the outer diameter of the cannula 3, or substantially equal to said outer caliber. In addition, the upstream opening of the bore may be arranged to facilitate the insertion of the cannula 3 into the bore, and the base 2 of the needle 1 is wide enough to facilitate the introduction of the cannula 3 in the upstream opening and the bore.
Ainsi, le praticien peut gagner du temps par rapport aux techniques d'injection classiques car il n'a pas à localiser le trou formé par l'aiguille 1 , puisque celle-ci reste positionnée dans ledit trou et que l'accès à la zone à traiter est matérialisé par l'ouverture amont de l'alésage, qui est facilement localisable. De ce fait, le praticien n'a donc pas besoin de recourir à des pratiques traumatisantes pour le patient, comme de pincer plusieurs fois la peau dudit patient pour repérer le trou en risquant de la faire saigner. Thus, the practitioner can save time compared to conventional injection techniques because he does not have to locate the hole formed by the needle 1, since it remains positioned in said hole and that access to the zone to be treated is materialized by the upstream opening of the bore, 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.
En outre, grâce au guidage de la canule 3 par l'aiguille 1 , le praticien tâtonne moins durant l'introduction de ladite canule, ce qui s'avère également moins traumatique pour le patient. In addition, by guiding the cannula 3 by the needle 1, the practitioner groping less during the introduction of said cannula, which is also less traumatic for the patient.
De plus, les opérations de manipulation de l'aiguille 1 sont limitées, ce qui permet de limiter les risques de piqûre accidentelle pour le praticien et le risque de perte de stérilité de ladite aiguille. Le procédé prévoit ensuite une étape d'injection du produit dans la zone à traiter par l'intermédiaire de la canule 3. En particulier, durant cette étape, le produit est injecté au moyen d'une seringue ou d'un autre type de contenant sur le(la)quel(le) la canule 3 est montée. In addition, the handling operations of the needle 1 are limited, which limits the risk of accidental puncture for the practitioner and the risk of loss of sterility of said needle. The method then provides a step of injecting the product into the area to be treated via the cannula 3. In particular, during this step, the product is injected by means of a syringe or other type of container. on which the cannula 3 is mounted.
Pour ce faire, la canule 3 présente une embase 5 sur laquelle l'extrémité proximale 3b de ladite canule est montée, par exemple en étant fixée au moyen d'un adhésif dans un logement prévu à cet effet sur ladite embase, ladite embase étant destinée à être montée sur un embout d'une seringue contenant le produit à injecter. To do this, the cannula 3 has a base 5 on which the proximal end 3b of said cannula is mounted, for example by being fixed by means of an adhesive in a housing provided for this purpose on said base, said base being intended to be mounted on a tip of a syringe containing the product to be injected.
Par exemple, l'embase 5 peut être de type Luer-Lock® ou Luer-Slip®, pour être montée respectivement par vissage ou par friction sur l'embout de la seringue, ces types étant avantageusement universels pour permettre l'utilisation de la canule 3 avec tous types de seringues ou d'autres contenants. For example, the base 5 can be of Luer-Lock® or Luer-Slip® type, to be mounted respectively by screwing or by friction on the tip of the syringe, these types being advantageously universal to allow the use of the cannula 3 with all types of syringes or other containers.
En outre, l'embase 5 de la canule 3 est agencée pour s'emboîter dans l'embase 2 de l'aiguille 1 à la fin du coulissement de ladite canule dans l'alésage, ce qui assure au praticien une stabilité du positionnement de la canule 3 avant de procéder à l'injection. In addition, the base 5 of the cannula 3 is arranged to fit into the base 2 of the needle 1 at the end of the sliding of said cannula into the bore, which ensures the practitioner stability of the positioning of the the cannula 3 before proceeding to the injection.
En relation avec la figure 4, la canule 3 comprend également un capuchon 9 de protection destiné à être monté sur l'embase 5 en entourant ladite canule, afin d'assurer la protection et éventuellement une parfaite stérilité de ladite canule avant son utilisation. In connection with Figure 4, the cannula 3 also comprises a protective cap 9 to be mounted on the base 5 surrounding said cannula, to ensure the protection and possibly perfect sterility of said cannula before use.
Par ailleurs, l'embase 5 et le capuchon 9 peuvent également être réalisés en polypropylène ou en un copolymère de polypropylène, notamment l'éthylène- polypropylène. De façon générale, l'embase 5 et le capuchon 9 peuvent être réalisés en un matériau ininflammable, notamment dépourvu de pyrogène. Selon le produit à injecter, la profondeur de la zone à traiter et/ou sa localisation par rapport au trou d'accès, les dimensions de la canule 3 peuvent varier. En particulier, la canule 3 peut présenter un calibre interne réduit si le produit est fluide et au contraire plus important si le produit est épais. Ainsi, avec un calibre interne large, le praticien peut injecter un produit épais sans appliquer de pression trop importante audit produit, ce qui permet de faciliter ladite injection et de réduire la douleur pour le patient. Par ailleurs, en appliquant moins de pression, les molécules du produit sont moins soumises à des contraintes physiques et donc moins susceptibles d'être détériorées. Furthermore, the base 5 and the cap 9 may also be made of polypropylene or a polypropylene copolymer, especially ethylene-polypropylene. In general, the base 5 and the cap 9 may be made of a non-flammable material, in particular without pyrogen. Depending on the product to be injected, the depth of the zone to be treated and / or its location relative to the access hole, the dimensions of the cannula 3 may vary. In particular, the cannula 3 may have a reduced internal size if the product is fluid and on the contrary more important if the product is thick. Thus, with a large internal caliber, the practitioner can inject a thick product without applying too much pressure to said product, which facilitates said injection and reduce pain for the patient. Moreover, by applying less pressure, the molecules of the product are less subject to physical constraints and therefore less likely to be deteriorated.
Par exemple, la canule 3 peut présenter un calibre externe compris entre 14G (14 gauges, ce qui correspond à un diamètre de 2 mm) et 33G (0,2 mm), et notamment entre 22G (0,7 mm) et 25G (0,5 mm). La canule 3 peut également être flexible, afin de faciliter son guidage vers la zone à traiter, puis le positionnement de son orifice d'injection 4 dans ladite zone à traiter. En particulier, la flexibilité de la canule 3 est liée au calibre externe, ladite flexibilité étant d'autant plus importante que ledit calibre externe est réduit. En outre, la canule 3 peut être au moins partiellement réalisée en acier inoxydable, notamment en alliage SUS 304 ou en alliage AISI 304 (de formule chimique brute FeCnsNi-io), ce dernier étant particulièrement remarquable pour ses bonnes performances en termes de flexibilité, de robustesse, d'élasticité et de résistance à la corrosion, et/ou en un alliage à mémoire de forme. For example, the cannula 3 may have an external gauge between 14G (14 gauges, which corresponds to a diameter of 2 mm) and 33G (0.2 mm), and especially between 22G (0.7 mm) and 25G ( 0.5 mm). The cannula 3 can also be flexible, to facilitate its guidance to the area to be treated, and then the positioning of its injection port 4 in said area to be treated. In particular, the flexibility of the cannula 3 is related to the outer caliber, said flexibility being all the more important that said outer caliber is reduced. In addition, the cannula 3 may be at least partially made of stainless steel, in particular alloy SUS 304 or alloy AISI 304 (crude chemical formula FeCnsNi-10), the latter being particularly remarkable for its good performance in terms of flexibility, robustness, elasticity and resistance to corrosion, and / or a shape memory alloy.
De plus, la surface extérieure de la canule 3 peut avoir subi un traitement spécial, par exemple à base de silicone, afin de faciliter le coulissement de ladite canule sous la peau du patient, et donc de minimiser les traumatismes pour ledit patient, notamment les hématomes, les ecchymoses ou les œdèmes. In addition, the outer surface of the cannula 3 may have undergone a special treatment, for example based on silicone, in order to facilitate the sliding of said cannula under the skin of the patient, and thus to minimize the trauma for said patient, in particular the hematomas, bruises or edema.
Pour permettre au praticien d'identifier rapidement le calibre externe et/ou le calibre interne de la canule 3, et ainsi sélectionner ladite canule en fonction de ses besoins, l'embase 5 de ladite canule peut comprendre un marquage d'identification de son calibre externe et/ou de son calibre interne. To allow the practitioner to quickly identify the external caliber and / or the internal size of the cannula 3, and thus select said cannula according to its needs, the base 5 of said cannula may include an identification marking of its outer caliber and / or its internal caliber.
En particulier, le marquage d'identification consiste en une coloration de l'embase 5, la coloration correspondant au calibre interne et/ou au calibre externe de la canule 3, comme défini notamment par la norme NF EN ISO 6009. In particular, the identification marking consists of a coloration of the base 5, the coloration corresponding to the internal gauge and / or the external gauge of the cannula 3, as defined in particular by the NF EN ISO 6009 standard.
De même, l'embase 2 de l'aiguille 1 présente une coloration identique à celle de l'embase 5 de la canule 3, ce qui permet d'identifier ladite aiguille et ladite embase comme appartenant à un même kit d'injection. En particulier, l'aiguille 1 et la canule 3 d'un même kit peuvent être conditionnés dans un même sachet stérile transparent, notamment à base de polypropylène et/ou de polyéthylène, ledit sachet pouvant en outre être souple ou rigide et/ou comprendre au moins une portion à base de papier pelable. Similarly, the base 2 of the needle 1 has a coloration identical to that of the base 5 of the cannula 3, which identifies said needle and said base as belonging to the same injection kit. In particular, the needle 1 and the cannula 3 of the same kit may be packaged in the same transparent sterile bag, in particular based on polypropylene and / or polyethylene, said bag may also be flexible or rigid and / or include at least one portion based on peelable paper.
Le kit ainsi conditionné peut être stocké dans une boîte contenant d'autres kits également conditionnés en sachets afin d'être protégés de l'humidité et de la lumière durant leur stockage, le praticien identifiant en un coup d'œil le kit dont il a besoin en regardant la coloration des embases 2, 5. The kit thus packaged can be stored in a box containing other kits also packaged in sachets to be protected from moisture and light during storage, the practitioner identifying at a glance the kit he has need by looking at the coloration of the bases 2, 5.
Par ailleurs, avant et/ou après leur conditionnement en sachet, l'aiguille 1 et la canule 3 d'un kit sont stérilisées, par exemple au moyen d'un procédé de stérilisation par oxyde d'éthylène (ETO), par rayonnement ionisant ou par vapeur. De plus, le sachet peut comprendre des indications pour le praticien, comme un numéro de lot, les références des tests de conformité effectués et/ou les dimensions de la canule 3 et/ou de l'aiguille, et notamment des informations utiles pour une utilisation sans danger du kit qu'il contient, par exemple une date de stérilisation et/ou une date de péremption, une notion restreignant l'usage à des praticiens qualifiés, une référence à l'organisme notifié et/ou un marquage de conformité à une norme, notamment la norme CE. En particulier, si le sachet présente un mauvais état et/ou une ouverture, le praticien peut savoir immédiatement que le kit contenu dans ledit sachet doit être détruit pour la sécurité du patient. Moreover, before and / or after their packaging in a bag, the needle 1 and the cannula 3 of a kit are sterilized, for example by means of a process of sterilization by ethylene oxide (ETO), by ionizing radiation or by steam. In addition, the sachet may include indications for the practitioner, such as a lot number, the references of the conformity tests performed and / or the dimensions of the cannula 3 and / or the needle, and in particular information useful for safe use of the kit it contains, for example a date of sterilization and / or an expiry date, a notion restricting the use to qualified practitioners, a reference to the notified body and / or a marking of conformity to a standard, including the CE standard. In particular, if the bag has a poor condition and / or an opening, the practitioner can know immediately that the kit contained in said bag must be destroyed for the safety of the patient.
En relation avec la figure 2, la canule 3 peut présenter une longueur variable, selon la profondeur et/ou la localisation de la zone à traiter avec ladite canule par rapport au trou d'accès. Cette longueur peut notamment être comprise entre 13 mm et 1 10 mm, et plus particulièrement comprise entre 25 mm et 70 mm. In relation with FIG. 2, the cannula 3 may have a variable length, depending on the depth and / or the location of the zone to be treated with said cannula relative to the access hole. This length may especially be between 13 mm and 1 10 mm, and more particularly between 25 mm and 70 mm.
De plus, comme représenté sur la figure 2, l'aiguille 1 présente une longueur plus ou moins importante selon la longueur de la canule 3 associée, afin d'assurer un guidage adapté à ladite longueur. La longueur de l'aiguille 1 peut notamment être comprise entre 4 mm et 30 mm. In addition, as shown in Figure 2, the needle 1 has a greater or lesser length depending on the length of the associated cannula 3, to ensure a guide adapted to said length. The length of the needle 1 may in particular be between 4 mm and 30 mm.
Pour faciliter le positionnement de l'orifice d'injection 4 dans la zone à traiter, notamment lorsque celle-ci est localisée à une profondeur importante et/ou à une distance importante du trou d'accès, la canule 3 peut présenter des graduations 6 ménagées à des intervalles réguliers sur sa longueur, par exemple tous les centimètres. Par ailleurs, l'embase 5 de la canule 3 peut comprendre sur sa périphérie un marquage 7 de repérage de l'orifice d'injection 4 qui est aligné avec ledit orifice d'injection, ce qui permet au praticien d'orienter correctement ledit orifice d'injection lorsque celui-ci est positionné dans la zone à traiter. En relation avec les figures, le marquage de repérage comprend un point 7 ménagé sur la périphérie de l'embase 5, ledit point étant réalisé en une couleur suffisamment voyante pour contraster avec la couleur de ladite embase. En variante, le marquage de repérage peut présenter un autre motif, notamment en forme de flèche. Il peut en outre être réalisé en relief sur l'embase 5, par exemple lors du moulage de ladite embase, et éventuellement coloré avec une teinte différente de ladite embase. Pour limiter la douleur ressentie par le patient durant l'intervention, le procédé peut prévoir une étape préalable au perçage de la peau, dans laquelle un produit anesthésiant est appliqué au moins sur et/ou dans la zone à percer, ce qui permet de limiter à la fois la douleur due audit perçage et la douleur due à l'introduction de la canule 3. En particulier, le produit anesthésiant peut être appliqué localement sous forme de crème et/ou de patch, par exemple un patch de type Emla®. To facilitate the positioning of the injection orifice 4 in the area to be treated, especially when the latter is located at a large depth and / or at a large distance from the access hole, the cannula 3 may have graduations 6. arranged at regular intervals along its length, for example every centimeter. Furthermore, the base 5 of the cannula 3 may comprise on its periphery a marking 7 for locating the injection orifice 4 which is aligned with said injection orifice, which allows the practitioner to correctly orient said orifice. when it is positioned in the area to be treated. In connection with the figures, the marking of marking comprises a point 7 formed on the periphery of the base 5, said point being made in a sufficiently bright color to contrast with the color of said base. In a variant, the marking may have another pattern, in particular in the form of an arrow. It can also be made in relief on the base 5, for example during the molding of said base, and optionally colored with a different shade of said base. To limit the pain felt by the patient during the procedure, the method may provide a step prior to piercing the skin, wherein an anesthetic is applied at least on and / or in the area to be pierced, thereby limiting both the pain due to said piercing and the pain due to the introduction of the cannula 3. In particular, the anesthetic product can be applied locally in the form of cream and / or patch, for example an Emla® type patch.
Par ailleurs, le procédé peut prévoir de traiter successivement plusieurs zones, et ce en y accédant à partir du même trou d'accès, ce qui est grandement facilité par le maintien de l'aiguille 1 dans ledit trou pour assurer le guidage des canules 3. Par exemple, si le praticien doit changer de canule 3, notamment pour changer de produit ou pour utiliser une canule 3 de longueur et/ou de calibre interne différent(s), le fait de laisser l'aiguille 1 en place permet de faciliter l'insertion de nouvelles canules 3 par ledit trou d'accès, et donc de gagner du temps. Furthermore, the method may provide for successively treating several zones, and this by accessing from the same access hole, which is greatly facilitated by the maintenance of the needle 1 in said hole to guide the cannulas 3 For example, if the practitioner has to change the cannula 3, in particular to change product or to use a cannula 3 of different length and / or internal gauge, leaving the needle 1 in place makes it easier to inserting new cannulas 3 through said access hole, and thus save time.
Pour ce faire, un même kit peut comprendre plusieurs canules 3 qui présentent par exemple un même calibre externe, mais des calibres internes et/ou des longueurs différentes, afin de permettre au praticien de réaliser plusieurs injections avec plusieurs produits et/ou dans plusieurs zones à traiter à l'aide d'un seul kit. En outre, un même kit peut également comprendre plusieurs aiguilles 1 qui présentent par exemple des longueurs différentes. To do this, the same kit may include several cannulas 3 which have for example the same external template, but different internal templates and / or lengths, to allow the practitioner to perform several injections with several products and / or in multiple areas to be treated with one kit. In addition, the same kit may also include several needles 1 which have for example different lengths.
En particulier, le praticien peut injecter plusieurs produits dans une même zone selon les effets esthétiques qu'il souhaite apporter à ladite zone. Par exemple, le praticien peut injecter plusieurs produits de même type qui présentent des viscosités différentes et/ou un même produit à des profondeurs différentes. In particular, the practitioner can inject several products in the same area according to the aesthetic effects he wishes to bring to said area. For example, the practitioner can inject several products of the same type which have different viscosities and / or the same product at different depths.
Par ailleurs, pour l'injection d'un même produit dans plusieurs zones à traiter, le procédé peut prévoir de déplacer une canule 3 déjà introduite dans l'alésage de l'aiguille 1 vers une autre zone à traiter après injection dudit produit dans une première zone. De façon avantageuse, le praticien peut utiliser une aiguille 1 montée rétractable sur son embase 2, ladite aiguille étant rétractée dans ladite embase après passage de la canule 3 au-delà de l'extrémité 1 a, c'est-à-dire après insertion de la canule 3 sous la peau au moyen de l'aiguille 1 . Ainsi, l'injection peut être réalisée uniquement avec la canule 3 insérée dans la peau, ce qui permet au praticien de manipuler plus facilement ladite canule et de réaliser une injection de façon moins traumatique pour le patient. Moreover, for the injection of the same product into several areas to be treated, the method can provide for moving a cannula 3 already introduced into the bore of the needle 1 to another area to be treated after injection of said product in a first zone. Advantageously, the practitioner may use a retractable mounted needle 1 on its base 2, said needle being retracted into said base after passage of the cannula 3 beyond the end 1a, that is to say after insertion of the cannula 3 under the skin by means of the needle 1. Thus, the injection can be performed only with the cannula 3 inserted into the skin, which allows the practitioner to more easily manipulate said cannula and perform an injection less traumatic for the patient.
En particulier, lorsque le produit doit être injecté dans plusieurs zones, l'aiguille 1 peut être rétractée avant déplacement de la canule 3 vers une autre zone à traiter, afin d'éviter de blesser le patient dans la zone située autour du trou d'accès. In particular, when the product has to be injected into several areas, the needle 1 can be retracted before displacement of the cannula 3 to another area to be treated, in order to avoid injuring the patient in the area around the hole. access.
En particulier, le procédé peut prévoir un déplacement radial entre la zone qui vient d'être traitée et une nouvelle zone à traiter pour procéder à une nouvelle injection dans ladite nouvelle zone. In particular, the method may provide a radial displacement between the area that has just been treated and a new area to be treated to proceed to a new injection in said new area.
En outre, le procédé peut prévoir de répéter au moins une fois un tel déplacement radial depuis la zone traitée vers une autre zone à traiter et une étape consécutive d'injection de produit dans ladite autre zone. Ainsi, le praticien peut traiter toute une zone du visage, par exemple le front, une tempe ou une joue, et ce à partir d'un seul trou d'accès. In addition, the method may provide for repeating at least once such radial displacement from the treated area to another area to be treated and a subsequent step of injecting product into said other area. Thus, the practitioner can treat an entire area of the face, for example the forehead, a temple or a cheek, and this from a single access hole.
Pour corriger un relâchement de la peau largement étendu sur une zone du visage, par exemple sur le front, sur une tempe ou sur une joue, une technique connue consiste à injecter du produit par bolus, c'est-à-dire à déposer plusieurs petites doses de produit sur l'ensemble de ladite zone en effectuant plusieurs déplacements dans ladite zone, afin d'étirer ladite peau sur toute la zone tout en lui redonnant du volume. In order to correct a loosening of the skin which is widely spread over an area of the face, for example on the forehead, on a temple or on a cheek, a known technique consists in injecting the product by bolus, that is to say, depositing several small doses of product on the whole of said zone by making several displacements in said zone, in order to stretch said skin over the whole area while giving it back volume.
En particulier, le praticien peut procéder à plusieurs injections par bolus en effectuant plusieurs déplacements radiaux, notamment en éventail, dans une même zone. Le praticien peut également utiliser une technique particulière appelée « nappage » qui est généralement réalisée dans une couche de l'hypoderme, afin de réaliser un lissage en surface et de repulper la peau en profondeur. En déplaçant radialement la canule 3 déjà insérée dans la couche hypodermique depuis une zone déjà traitée de ladite couche vers une autre zone à traiter, ladite canule reste notamment à une profondeur constante. Ainsi, le praticien s'assure de réaliser toutes les injections de nappage dans une même couche, et notamment à une même profondeur dans ladite couche. In particular, the practitioner can perform several bolus injections by performing several radial movements, including fan, in the same area. The practitioner can also use a particular technique called "topping" which is usually performed in a layer of the hypodermis, in order to achieve a smoothing surface and plump the skin deep. By radially moving the cannula 3 already inserted into the hypodermic layer from an already treated area of said layer to another area to be treated, said cannula remains in particular at a constant depth. Thus, the practitioner makes sure to perform all the injections of topping in the same layer, and in particular at the same depth in said layer.
De ce fait, le praticien peut facilement repulper une couche sous la peau avec une épaisseur constante de produit, ce qui permet de garantir l'homogénéité et l'harmonie du résultat final. Par ailleurs, le procédé peut prévoir de déplacer la canule 3 en arrière pendant l'injection par bolus du produit, c'est-à-dire suivant un mouvement rétrograde, afin de répartir ledit produit sur un intervalle de profondeurs important et/ou sur une zone plus large, ce qui permet un résultat plus harmonieux et donc plus naturel. En variante, le procédé peut prévoir de déplacer la canule 3 en avant, suivant un mouvement antégrade, durant l'injection par bolus du produit. Therefore, the practitioner can easily plump a layer under the skin with a constant thickness of product, which ensures the homogeneity and harmony of the final result. On the other hand, the method may provide for moving the cannula 3 back during the bolus injection of the product, i.e., in a retrograde motion, to distribute the product over a substantial depth range and / or a wider area, which allows a more harmonious and therefore more natural result. Alternatively, the method may provide for moving the cannula 3 forward, in antegrade motion, during the bolus injection of the product.
Une fois les injections terminées, le praticien retire facilement la canule 3 grâce au guidage dans l'alésage de l'aiguille 1 et peut effectuer un massage sur la zone traitée, afin de répartir uniformément le produit et donner un aspect plus homogène et donc plus naturel à la correction apportée. Le patient peut alors constater des résultats immédiatement visibles et durables. Once the injections are complete, the practitioner easily removes the cannula 3 through guiding in the bore of the needle 1 and can perform a massage on the treated area, in order to evenly distribute the product and give a more homogeneous appearance and therefore more natural to the correction made. The patient can then see results that are immediately visible and lasting.

Claims

REVENDICATIONS
1 . Procédé d'injection d'un produit dans le cadre d'une intervention esthétique, ledit procédé prévoyant les étapes successives suivantes de : 1. A method of injecting a product in the context of an aesthetic intervention, said method providing the following successive steps of:
- perçage d'une zone de la peau d'un patient au moyen d'une aiguille (1 ) présentant une extrémité distale acérée (1 a), ladite aiguille comprenant un alésage qui s'étend entre une ouverture amont et une ouverture aval débouchant dans ladite extrémité distale ;  piercing an area of the skin of a patient by means of a needle (1) having a sharp distal end (1 a), said needle comprising a bore which extends between an upstream opening and a downstream opening opening in said distal end;
- introduction dans ledit alésage par ladite ouverture amont d'une canule d'injection (3) qui présente au moins un orifice d'injection (4) ;  - introducing into said bore through said upstream opening of an injection cannula (3) which has at least one injection port (4);
- coulissement de ladite canule d'injection au-delà de l'extrémité distale (1 a) jusqu'à ce que l'orifice d'injection (4) débouche dans une zone à traiter située sous la peau ;  sliding of said injection cannula beyond the distal end (1 a) until the injection orifice (4) opens into a zone to be treated situated under the skin;
- injection du produit dans ladite zone à traiter par l'intermédiaire de la canule d'injection (3).  injecting the product into said zone to be treated via the injection cannula (3).
2. Procédé d'injection selon la revendication 1 , caractérisé en ce qu'il prévoit d'injecter un produit successivement dans plusieurs zones à traiter, la canule (3) introduite dans l'alésage étant déplacée vers une autre zone à traiter après injection du produit dans une zone à traiter. 2. Injection method according to claim 1, characterized in that it provides to inject a product successively in several areas to be treated, the cannula (3) introduced into the bore being moved to another area to be treated after injection of the product in an area to be treated.
3. Procédé d'injection selon la revendication 1 ou 2, caractérisé en ce qu'il prévoit de rétracter l'aiguille (1 ) après passage de la canule (3) au-delà de l'extrémité distale acérée (1 a). 3. Injection method according to claim 1 or 2, characterized in that it provides for retracting the needle (1) after passage of the cannula (3) beyond the sharp distal end (1a).
4. Procédé d'injection selon l'une des revendications 1 à 3, caractérisé en ce que le produit est un produit de comblement, notamment à base d'acide hyaluronique. 4. Injection method according to one of claims 1 to 3, characterized in that the product is a filler, in particular based on hyaluronic acid.
5. Procédé d'injection selon l'une quelconque des revendications 1 à 4, caractérisé en ce que la zone de la peau percée est située sur le visage du patient, la zone à traiter étant située sur le visage et/ou le cou du patient. 5. Injection method according to any one of claims 1 to 4, characterized in that the area of the pierced skin is located on the patient's face, the area to be treated being located on the face and / or the neck of the patient. patient.
6. Procédé d'injection selon l'une quelconque des revendications 1 à 5, caractérisé en ce que la zone à traiter est située dans le stratum granulosum ou sous l'épiderme du patient. 6. Injection method according to any one of claims 1 to 5, characterized in that the area to be treated is located in the stratum granulosum or under the epidermis of the patient.
7. Kit d'injection d'un produit, notamment dans le cadre d'une intervention esthétique, ledit kit comprenant : 7. A product injection kit, particularly in the context of an aesthetic intervention, said kit comprising:
- au moins une canule d'injection (3) qui présente au moins un orifice d'injection (4) ;  - At least one injection cannula (3) having at least one injection port (4);
- au moins une aiguille (1 ) de perçage de la peau d'un patient qui présente une extrémité distale acérée (1 a), ainsi qu'un alésage s'étendant entre une ouverture amont et une ouverture aval qui débouche dans ladite extrémité distale, ledit alésage étant agencé pour permettre le coulissement de la canule d'injection (3) au-delà de l'extrémité distale (1 a) vers au moins une zone à traiter située sous la peau.  at least one needle (1) for piercing the skin of a patient that has a sharp distal end (1 a), and a bore extending between an upstream opening and a downstream opening that opens into said distal end , said bore being arranged to allow the sliding of the injection cannula (3) beyond the distal end (1 a) to at least one area to be treated located under the skin.
8. Kit d'injection selon la revendication 7, caractérisé en ce que la canule d'injection présente une extrémité distale arrondie (3a), l'orifice d'injection (4) étant disposé latéralement à proximité de ladite extrémité distale arrondie. 8. Injection kit according to claim 7, characterized in that the injection cannula has a rounded distal end (3a), the injection port (4) being disposed laterally close to said rounded distal end.
9. Kit d'injection selon la revendication 7 ou 8, caractérisé en ce que la canule d'injection (3) présente une longueur comprise entre 13 mm et 1 10 mm, notamment comprise entre 25 mm et 70 mm. 9. Injection kit according to claim 7 or 8, characterized in that the injection cannula (3) has a length of between 13 mm and 1 10 mm, in particular between 25 mm and 70 mm.
10. Kit d'injection selon l'une quelconque des revendications 7 à 9, caractérisé en ce que la canule d'injection (3) présente un calibre externe compris entre 14G et 33G, notamment entre 22G et 25G. 10. Injection kit according to any one of claims 7 to 9, characterized in that the injection cannula (3) has an outer gauge between 14G and 33G, especially between 22G and 25G.
1 1 . Kit d'injection selon l'une quelconque des revendications 7 à 10, caractérisé en ce que la canule d'injection (3) est flexible. 1 1. Injection kit according to one of claims 7 to 10, characterized in that the injection cannula (3) is flexible.
12. Kit d'injection selon l'une quelconque des revendications 7 à 1 1 , caractérisé en ce que l'aiguille de perçage (1 ) et la canule d'injection (3) présentent chacune une embase (2, 5) sur laquelle leurs extrémités proximales (1 b, 3b) respectives sont fixées, l'embase (5) de la canule d'injection (3) étant agencée pour s'emboiter dans l'embase (2) de l'aiguille de perçage (1 ) à la fin du coulissement de ladite canule dans l'alésage de ladite aiguille. Injection kit according to one of claims 7 to 11, characterized in that the piercing needle (1) and the injection cannula (3) each have a base (2, 5) on which their proximal ends (1b, 3b) respectively are fixed, the base (5) of the injection cannula (3) being arranged to fit into the base (2) of the piercing needle (1) at the end of the sliding of said cannula in the bore of said needle.
13. Kit d'injection selon la revendication 12, caractérisé en ce que les embases (2, 5) comprennent chacune un marquage d'identification identique du calibre externe et/ou du calibre interne de la canule (3). 13. injection kit according to claim 12, characterized in that the bases (2, 5) each comprise an identical identification marking of the outer caliber and / or the inner caliber of the cannula (3).
14. Kit d'injection selon la revendication 12 ou 13, caractérisé en ce que l'aiguille (1 ) est montée rétractable sur son embase (2). 14. Injection kit according to claim 12 or 13, characterized in that the needle (1) is retractably mounted on its base (2).
PCT/FR2014/052000 2013-07-31 2014-07-31 Method for injecting a product as part of an aesthetic intervention WO2015015127A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP14790167.2A EP3027261A2 (en) 2013-07-31 2014-07-31 Kit for injecting a product as part of an aesthetic intervention

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1357604A FR3009199A1 (en) 2013-07-31 2013-07-31 METHOD FOR INJECTING A PRODUCT IN THE CONTEXT OF A BEAUTY INTERVENTION
FR1357604 2013-07-31

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WO2015015127A3 WO2015015127A3 (en) 2015-04-09

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FR (1) FR3009199A1 (en)
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WO2019178513A1 (en) * 2018-03-16 2019-09-19 Siepser Steven B Transzonular intravitreal injector
US11464914B2 (en) * 2019-10-21 2022-10-11 Ripple Therapeutics Corporation Intravitreal injector

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016185145A1 (en) * 2015-05-19 2016-11-24 Peter Cumbo Injectable material injection device comprising a cannula that slides inside a needle, and system using such a device
FR3036289A1 (en) * 2015-05-19 2016-11-25 Peter Cumbo INJECTABLE PRODUCT INJECTION DEVICE HAVING SLIDING CANNULA IN A NEEDLE AND SYSTEM USING SUCH A DEVICE
US20180117263A1 (en) * 2015-05-19 2018-05-03 Peter Cumbo Injectable material injection device comprising a cannula that slides inside a needle, and system using such a device
CN109310406A (en) * 2016-04-20 2019-02-05 盖尔·密斯勒 Epidural needle component
US10569027B2 (en) * 2016-04-20 2020-02-25 Gayle MISLE Epidural needle assembly
WO2019178513A1 (en) * 2018-03-16 2019-09-19 Siepser Steven B Transzonular intravitreal injector
US11464914B2 (en) * 2019-10-21 2022-10-11 Ripple Therapeutics Corporation Intravitreal injector

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EP3027261A2 (en) 2016-06-08
FR3009199A1 (en) 2015-02-06

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