INJECTION DEVICE

Abstract

An injection for injecting at least one material into human keratinous materials that includes at least one treatment unit defining at least one cavity and at least one micro-implant made of said at least one material received in said cavity of the unit and having at least one portion having a same shape as the cavity; an injection device configured for applying a pressure to the at least one micro-implant to expel the latter out of the unit into the keratinous materials.

Claims

1. An injection system for injecting at least one material into human keratinous materials, comprising: at least one treatment unit defining at least one cavity and at least one micro-implant made of said at least one material received in said cavity of the unit and having at least one portion having a same shape as the cavity; an injection device configured for applying a pressure to the at least one micro-implant to expel the latter out of the unit into the keratinous materials.

2. The system of claim 1, wherein the unit comprises an application surface for contacting the keratinous materials when the at least one micro-implant is expelled out of the unit.

3. The system of claim 1, wherein the unit defines a plurality of cavities, with a plurality of micro-implants that are each received in a corresponding cavity of the unit and each have at least one portion of a same shape as the corresponding cavity.

4. The system of claim 1, wherein the unit comprises a core defining at least partially the at least one cavity and being polymeric.

5. The system of claim 1, wherein the unit comprises at least one puncturable region through which the at least one micro-implant is expelled.

6. The system of claim 1, wherein the unit comprises at least one puncturable membrane fixed onto a core defining at least partially the at least one cavity and through which the at least one micro-implant is expelled.

7. The system of claim 1, wherein the unit comprises a core defining at least partially the at least one cavity and the unit comprises a protective cover fixed onto the core on the proximal side of at least one micro-implant.

8. The system of claim 1, wherein the injection device comprises at least one impacting member configured for contacting a proximal end of the at least one micro-implant to expel it out of the unit.

9. The system of claim 1, wherein the unit comprises a squeezable core defining at least partially the at least one cavity.

10. The system of claim 1, wherein some of the micro-implants are made of a first material and some others are made of at least one second material different from the first one.

11. The system of claim 1, further comprising a reservoir for storing a liquid, the liquid and the material of the micro-implants being selected so that the liquid dissolves the material or react to generate another material.

12. The system of claim 1, further comprising an image sensor and a processor for automated detection of a target zone of the keratinous material, such as a skin default, and for signaling a user when the system is properly positioned relative to the target zone prior to expelling the at least one micro-implant and/or for automated triggering of the injection of the at least one micro-implant when the system is properly positioned relative to the target zone.

13. A unit suitable for use in a system as defined in claim 1, comprising: a core defining at least partially at least one cavity, at least one micro-implant made of said at least one material and received in a corresponding cavity of the core and having at least one portion having a same shape as the corresponding cavity.

14. A method of manufacturing a unit used in a system as defined in claim 1, comprising molding the at least one micro-implant in the corresponding cavity of the unit.

15. A non-therapeutic method for treating keratinous materials, comprising injecting at least one micro-implant into the keratinous materials using the system as defined in claim 1.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0108] The invention will be better understood in view of the following description of non-limitative embodiments and in view of the appended drawings in which:

[0109] FIG. 1 is a schematic view of a mold used for the manufacture of micro-implants according to the prior art,

[0110] FIGS. 2A to 2C illustrate the unmolding and the use of the micro-implants according to the prior art,

[0111] FIG. 3 is a partial and schematic view in longitudinal section of an injection system according to an exemplary embodiment of the invention,

[0112] FIG. 4 is a perspective view of the device of FIG. 3,

[0113] FIG. 5 shows in isolation a micro-implant,

[0114] FIG. 6 shows a treatment unit comprising micro-implants according to a variant embodiment,

[0115] FIG. 7A illustrates the ejection of the micro-implants out of the unit of FIG. 6,

[0116] FIG. 7B illustrates the injection of the micro-implants of the unit of FIG. 6 in the dermis or epidermis,

[0117] FIG. 7C shows the unit of FIG. 6 after ejection of the micro-implants,

[0118] FIGS. 8 and 9 show variant embodiments of treatment units,

[0119] FIG. 10 is a schematic and partial view of a variant embodiment of a device in accordance with the invention,

[0120] FIGS. 11 and 12 are similar views to FIG. 10 of variant embodiments,

[0121] FIG. 13 shows a set of treatment units,

[0122] FIG. 14 shows a variant embodiment of a unit,

[0123] FIG. 15 is a schematic block diagram of a variant of an injection device,

[0124] FIG. 16 illustrates a composite micro-implant,

[0125] FIG. 17 shows in elevation a variant embodiment of a micro-implant,

[0126] FIG. 18 shows a variant of unit,

[0127] FIG. 19 shows another variant of unit,

[0128] FIG. 20 is a schematic representation of a variant of an injection device, and

[0129] FIG. 21 shows a unit comprising a column of micro-implants.

DETAILED DESCRIPTION OF THE DRAWINGS

[0130] The injecting system 10 shown in FIGS. 3 and 4 comprises a treatment unit 20 and an injection device 30 for acting on the unit 20.

[0131] The unit 20 comprises a core 21 and micro-implants 40 housed therein.

[0132] One micro-implant 40 is shown in FIG. 5. It may comprise as shown a cylindrical portion 41 of length l.sub.p and diameter c and a conical head 42. The overall length e of the micro-implant may range from 25 μm to 2000 μm. The diameter c may range from 100 microns to 3 mm. The length of the proximal portion l.sub.p may range from 50 μm to 50 mm. The diameter c is for example equal to 350 microns. The length e is for example equal to 500 microns. The length l.sub.p is for example equal to 250 microns.

[0133] The micro-implant 40 is to be injected in its entirety in the stratum corneum, epidermis or dermis and is made of one or more materials selected depending the desired action.

[0134] For example, the micro-implants 40 are made of hyaluronic acid or derivatives thereof.

[0135] The core 21 serves as a mold for the shaping of the micro-implants 40 and serves to protect them until use.

[0136] Various materials may be used for the core 21 depending the way the micro-implants 40 are forced out of it.

[0137] In the embodiment of FIGS. 3 and 4, the material of the core 21 is selected to allow the micro-implants 40 to be extracted when the impacting member of the injecting device 30 applies on their upper end 43 a force directed toward their tip 44.

[0138] This force is exerted in this embodiment by a corresponding rod 31 held by a plate 32 that moves in a cylindrical guide 33. The plate 32 may be attached by its face opposite the rods 31 to a stem 34 that is connected to a driving mechanism (not shown) configured for moving the stem forward when the micro-implants 40 are to be forced into the skin.

[0139] The driving mechanism may comprise an electromechanical device such as an electrical motor or a spring.

[0140] The invention is not limited to a specific device for driving the rods 31 and the latter may be driven in various manners based for example on a pyrotechnic device, a pneumatic or a hydraulic device, inter alia, or manual force.

[0141] When the rods 31 are forced against the micro-implants 40, the latter are expelled from the unit 20 and penetrate in the dermis or epidermis. The core 21 may deform elastically to allow the micro-implants to leave their corresponding cavity within the core 21. The core 21 may comprise portions that are perforated by the micro-implants 40 or torn or otherwise damaged.

[0142] The rods 31 are preferably of a cylindrical shape of same diameter as the micro-implants 40 and are centered with respect to the micro-implants 40. This way the rods 31 can penetrate into the cavities to push the micro-implants.

[0143] Their length is preferably greater than e so that there is no need to compress the core 21 with the plate 32 to expel the micro-implants 40 out of it.

[0144] The end face of the rods 31 is preferably of a shape that is complementary to that of the end of the micro-implants that will be impacted by the rod.

[0145] The end face of the rods 31 may be flat and perpendicular to the longitudinal axis of the guide 33, as shown. The proximal end 43 of the micro-implants 40 preferably has a corresponding flat surface, so that the area of contact between the rod and the micro-implant is maximal. This help reduce the risk of fracturing the micro-implant when pushing it out of the mold.

[0146] To use the system depicted in FIGS. 3 and 4, the user places the unit 20 in a corresponding chamber of the injection device 30, and then positions the system 10 so that the unit 20 is positioned against the zone where the micro-implants should be injected.

[0147] Then, the user triggers the driving mechanism that causes the rods 31 to hit the micro-implants and expel them out of the core 21.

[0148] Once the micro-implants are within the stratum corneum, epidermis, and/or dermis the user may withdraw the injection system 10 and proceed to the replacement of the treatment unit with a new one.

[0149] Normally, the micro-implants are expelled in their entirety in the stratum corneum, epidermis or dermis, and there should not remain any non-injected portions of the micro-implants 40 trapped within the core 21.

[0150] A variant embodiment of a treatment unit 20 will now be described with reference to FIG. 6.

[0151] The unit 20 comprises in this embodiment a core 21 defining cavities 26 having the same shape as the micro-implants 40 contained therein, and protective films 28 and 29 covering respectively the proximal and distal faces of the core 21.

[0152] The bottom of the cavities 26 lie at a non-zero distance from the distal face of the core 21 so that the cavities are closed at their bottom end by the material of the core 21.

[0153] The cavities 26 are closed at their opposite end by the film 28, which contacts one end of the micro-implants 40.

[0154] The films 28 and 29 constitute a barrier that helps preserve sterile conditions of the micro-implants 40.

[0155] Films 28 and 29 may remain on the core 21 when the unit is used. In a variant, the films 28 and/or 29 are removed prior the placement of the unit in the injection device.

[0156] When the films 28 and/or 29 are present in the injection device during use thereof, the films may be perforated during the injection process.

[0157] The core 21 may be made of a material than can be compressed during the injection phase, that may be performed thanks to an injection device comprising as the impacting member a pressure plate 38 as shown in FIG. 7A.

[0158] The pressure plate 38 may have a planar surface intended to contact the film 28. The pressure is transmitted to the proximal end of the micro-implants 40. The film 29 may lie on the zone where the micro-implants 40 are to be injected. The core 21 may collapse under the pressure that is exerted by the plate 38, thus allowing the micro-implants to be pushed forward through the film 29 into the dermis or epidermis D, as shown in FIG. 7B.

[0159] Once the compression has ceased, the core 21 may not restore its initial shape and thickness, as illustrated in FIG. 7C.

[0160] To manufacture the treatment unit 20, the core 21 is used as a mold for the material of the micro-implant or a precursor thereof. The films 28 and 29 may be attached to the core 21 after the micro-implants 40 are formed. In a variant, the film 29 may be attached to the core 21 before the material serving to make the micro-implants is poured in the cavities of the core 21. The film 28 may be attached to the core 21 before or after the material to make the micro-implants has hardened. If the film 28 is brought before the material has hardened, it may help the film 28 to adhere to the remainder of the unit 20.

[0161] A treatment unit 20 may comprise identical micro-implants 40 or micro-implants of different size and/or materials. The injection device 30 may be configured for selective injection of one or more of these micro-implants, depending on various criteria such as for example the size and/or nature of the zone to treat and/or the nature of the treatment to perform.

[0162] In the example shown in FIG. 8, the unit 20 forms a sealed package in which the micro-implants are isolated from ambient air by the material of the core and/or by a sealing membrane on the proximal side of the micro-implants.

[0163] FIG. 9 shows a variant of the unit 20 comprising various sets of micro-implants 40a, 40b, 40c and 40d made of different materials and/or shapes. Each set may be present in a specific region of the unit, for example a specific angular sector as shown.

[0164] The unit may comprise micro-implants of various heights and/or sizes.

[0165] The injection device may comprise a memory in which characteristics and locations of each micro-implant 40 of the unit 20 is stored. This information may be accessed based on an identifier of the unit. For example, the unit and or a packaging of the unit bears a barcode which is read by the injection system. Based on the read information, and/or on possible extra information inputted by the user on an HMI such as a keyboard or tactile screen for example, the injection system determines automatically which micro-implants should be expelled and injected in the skin.

[0166] The injection system may select automatically the micro-implants needed for injection based for example on the dose of each material to inject.

[0167] The injection device may comprise individual rods that may be controlled independently of the others. Rods can be of different length, diameter and shape. They can move up and down. There may be as many of these rods as there are micro-implants. The injection device may be configured to memorize the position of the micro-implants that have already been expelled out of the unit. In this way, the injection device can determine which rods should be actuated to expel the remaining micro-implants after each use.

[0168] The injection device may also contain less rods than there are micro-implants and the injection system is configured for allowing a displacement of the unit relative to the injection device once all the micro-implants of a given area of the unit have been expelled. This displacement may be a rotation of the unit 20 and/or of the rods 31 and plate 32, as shown in FIG. 10.

[0169] The system may also comprise one or more actuating rods that are carried by a carriage that is mobile relative to the unit in the x and y directions.

[0170] The injection system 10 may comprise at least one pressure sensor and be configured to allow injection only when a threshold pressure is exceeded on the skin. This helps reduce the suppleness of the skin and improve the penetration of the micro-implants in the skin

[0171] FIG. 11 shows an injection system in which the injection device 30 is equipped with a sensor 52 represented schematically, which may be a pressure sensor. This sensor provides an indication of the pressure of the injection system 10 against the skin. The injection device 30 may comprise a processor controlling the driving mechanism used for moving the rods 31 or other pressure means serving to expel the micro-implants 40. This processor receives the signal from the pressure sensor and can trigger the injection only once a given pressure is reached.

[0172] The presence of a pressure sensor in the injection device may help generate the right pressure for micro-implant insertion according to the skin mechanical properties.

[0173] As illustrated in FIG. 11, the injection system 10 may also comprise an identification sensor 55 to identify the unit 20 that is used. Based on this identification, the injection device may operate according to a specific program, for example.

[0174] Identification may be performed thanks to the presence on the unit of a specific mark, such as a barcode as mentioned above.

[0175] The core 21 may be made of a material that is soluble in a specific solvent, such as water for example. The unit 20 may be put into contact with this solvent prior to the micro-implants being expelled. The solvent may modify the rigidity of the core 21 and facilitate the deformation of the core that is necessary to allow the micro-implants to leave the core.

[0176] The injection may also take place in presence of a liquid selected to increase the solubility of the material of the micro-implants into the dermis or epidermis or other medium into which the micro-implants are injected.

[0177] This liquid L may be present above the unit 20 as shown in FIG. 12. The injection device 30 may first drive the micro-implants out of the core 21 and then force some liquid to follow the micro-implants into the dermis or epidermis.

[0178] A plurality of units 20 may be packaged in a same cartridge 50, as shown in FIG. 13. Such a cartridge may be tube-like.

[0179] The injection device 30 may then be configured to extract from the cartridge one unit 20 at a time. When a unit has been used, it is ejected from the system and a new unit is withdrawn from the cartridge.

[0180] The micro-implants 40 may be given various shapes, including shapes with undercuts that would prevent the micro-implants from being unmolded from the core 21.

[0181] As an example, FIG. 14 shows a treatment unit 20 comprising micro-implants 40 having an arrow shape. Such a shape allows better anchoring of the micro-implants in the tissue in which it has been injected. The micro-implants comprise at least one cutback 60 preventing them from unmolding.

[0182] The injection device may be provided with a target sensor that serves to recognize a given area in order to treat it automatically. For example, the target sensor detects a wrinkle and the injection device is configured to inject the micro-implants only in the wrinkle area.

[0183] The injection device may comprise as illustrated in FIG. 15 an image sensor 110 and a processor 111 for automated detection of a target zone of the keratinous material and for signaling a user when the system is properly positioned relative to the target zone prior to expelling the at least one micro-implant and/or for automated triggering of the injection of the at least one micro-implant when the system is properly positioned relative to the target zone.

[0184] The injection device may comprise an interface 112 and an actuator 113 for actuating an impacting member to expel the micro-implants. The interface 112 may comprise a tactile screen and/or some buttons to select operating parameters.

[0185] FIG. 16 illustrates the possibility for the micro-implants 40 to be of composite nature, with for example a distal portion 40b made of a material with higher hardness than the proximal portion 40a.

[0186] The distal end of the micro-implant may have various shapes. It is not necessarily conical. It may be flat, round or beveled, as shown in FIG. 17.

[0187] The core 21 may have an elongated shape and the units may be formed by cutting the elongated core in successive portions, as illustrated in FIG. 19. By varying the spacing between the cutting lines, one may vary the length of the micro-implants 40. The cutting line may be oblique relative to the longitudinal axis of the core 21 so as to form beveled distal ends for the micro-implants.

[0188] The core 21 may be flexible and deformed to take the shape of the body portion S against which the unit is applied prior to injection of the micro-implants, as shown in FIG. 19.

[0189] In the variant embodiment shown in FIG. 20; the injection device comprises an enclosure 110 that has an opening that is configured for being placed on the skin. A vacuum pump creates a vacuum in the space 100 inside the enclosure which causes the skin S to deform towards the unit. By varying the intensity of the vacuum, one may cause the skin to deform more or less towards the unit. In this way, the distance between the micro-implants and the skin may be varied and with it the depth of the penetration of the micro-implants into the skin. The vacuum may also help to homogenize skin properties prior to the injection.

[0190] In another embodiment shown in FIG. 21, micro-implants are superimposed axially in a column and are delivered to the skin one after the other, in a succession. The micro-implant situated at the bottom of the column is forced into the skin thanks to pressure applied on the micro-implant situated at the top. The micro-implants may be identical or made of different materials or have a varying concentration of an active ingredient. For example, the concentration varies from bottom to top, to take into account the need to vary the power of a treatment in time. The first injection delivers micro-implants with smaller concentration, and the concentration increases progressively with the following injections. In a variant; the first injection has the strongest concentration, and then the concentration decreases with the following injections.