Device for injecting into the skin by superficial incision, having mobile incision components

Abstract

A device (1) for injecting into the skin by superficial incision, the device (1) comprising an incision component (220, 230) comprising a tip (222, 232) oriented towards the outside of the device, the tip (222, 232) defining an ejection channel (280), the component defining a reservoir channel (282), the device (1) being configured to move the component when the tip is applied to the skin of a human or animal body, such that a volume of the ejection channel (280) is increased and a volume of the reservoir channel (282) is decreased.

Description

[0001] Description

[0002] Title of the invention: Device for injection into the skin by superficial incision with movable incision parts

[0003] FIELD OF THE INVENTION

[0004] The present invention relates to the field of devices for superficial incision of the skin of a human or animal body, in particular for carrying out an allergic diagnosis. Skin allergy diagnostic tests are generally called "prick tests".

[0005] STATE OF THE ART

[0006] Allergy diagnostic tests are medical examinations consisting of superficially penetrating a few micro-drops of an allergenic product into the upper part of the epidermis of a human or animal body, for example on the forearm, in order to test the reactivity of the human or animal to said product.

[0007] In practice, after placing a drop of product on the skin of a human or animal body, the skin is pricked through the drop with a pointed device, to penetrate the product under the skin, then fifteen to twenty minutes are waited before interpreting the skin reaction.

[0008] These testing devices present a risk of false negative error, that is, the risk of wrongly declaring that an allergic individual is not allergic, when the test product does not penetrate the skin or does not penetrate sufficiently.

[0009] There are also incision devices on the market that contain a vaccine solution, the incision device being able to cut the skin and simultaneously penetrate the vaccine into the skin.

[0010] These vaccine devices present a risk of non-vaccination when the vaccine solution does not penetrate the skin or does not penetrate sufficiently.

[0011] For both types of devices, the active product, i.e. the allergen product or the vaccine solution, can be retained in the device by surface tensions between the test product and a wall of the device.

[0012] There is therefore a need for a device for superficial incision of the skin of a human or animal body which allows sufficient penetration of an active product into the skin.

[0013] STATEMENT OF THE INVENTION

[0014] An aim of the invention is to propose a device for superficial incision of the skin of a human or animal body which allows sufficient penetration of an active product into the skin. The aim is achieved within the scope of the present invention by means of a device for injection into the skin by superficial incision, the device comprising an incision part comprising a tip oriented towards the outside of the device, the tip defining an ejection channel, the part defining a reservoir channel, the device being configured to move the part when the tip is applied to the skin of a human or animal body, so that a volume of the ejection channel is increased and a volume of the reservoir channel is decreased. The device comprises a reservoir channel and an ejection channel defined by the tip. By moving the part, the device can evolve so that the volume of the ejection channel increases and the volume of the reservoir channel decreases.An active product initially in the reservoir channel can thus be transported to the ejection channel and ultimately to the skin incised by the stitches. The quantity of active product that penetrates the skin increases.

[0015] Such a device is advantageously and optionally supplemented by the following different characteristics taken alone or in combination:

[0016] - the tip is located on a first side of a separation plane passing through the ejection channel, the incision part being mounted to be movable in rotation relative to a body of the device according to a pivot zone, the pivot zone being located outside the separation plane between the ejection channel and the reservoir channel;

[0017] - a lever located on the first side of the separation plane, the lever being rigidly connected to the part and the lever being connected to the body of the device by the pivot zone, the lever being configured to move the part when the lever comes to bear on the skin;

[0018] - a means of locking the lever;

[0019] - the locking means comprises complementary hooks on the body of the device and on an arm extending from one end of the lever;

[0020] - the part has a first wall which defines the reservoir channel, the first wall having a shape complementary to a second wall of the device located opposite the first wall;

[0021] - one of the first wall and the second wall has a convex zone opposite a concave zone of the other of the walls.

[0022] The invention also relates to a method of superficial incision in which a tip of a device for injection into the skin by superficial incision is applied to the skin of a human or animal body, the application resulting in a reduction of a volume of a reservoir channel and an increase of a volume of an ejection channel, the ejection channel being defined by the tip, so as to transport a liquid from the reservoir channel into the ejection channel. DESCRIPTION OF THE FIGURES

[0023] Other characteristics and advantages of the invention will emerge from the following description, which is purely illustrative and non-limiting, and must be read in conjunction with the appended drawings in which: Figure 1 is a schematic representation of a first caval view of an incision device according to a first embodiment of the invention; Figure 2 represents a partial detail view on an enlarged scale of one end of an incision device; Figures 3 and 4 represent the device in two successive stages of use for a skin incision.

[0024] DETAILED DESCRIPTION OF THE INVENTION

[0025] With reference to Figures 1 to 4, we will describe a main embodiment of the invention. These figures illustrate a device 1 for injection into the skin by superficial incision.

[0026] A longitudinal axis A is defined, defining a longitudinal direction, the axis along which the superficial incision device 1 extends.

[0027] Incision pieces

[0028] The device 1 comprises at least one incision piece 220, 230 located at a longitudinal end of the device.

[0029] The device 1 may comprise two incision pieces 220, 230 as shown in FIG. 1, or more incision pieces.

[0030] Optionally, the device may comprise a handle 100, i.e. a manual gripping area, at the other longitudinal end of the device 1.

[0031] The incision part(s) 220, 230 are part of an incision assembly 200 of the device 1.

[0032] The device may be described as consisting of the incision assembly 200 comprising the incision part(s) 220, 230, and a body 150 of the device which may optionally comprise the handle 100.

[0033] For example, the incision part extends opposite a fixed part of the device 1 in the longitudinal direction. The part can be separated from this fixed part by a gap in a lateral axis B, defining a lateral direction. This lateral gap between the tip and the fixed part makes it possible to define an ejection channel. The lateral axis B is orthogonal to the longitudinal axis A. A third axis C, or transverse axis, can be defined, which is orthogonal to the longitudinal axis A and to the lateral axis B.

[0034] In the case where the device comprises two incision pieces, and as illustrated in figures 1 and 2, these extend opposite each other in the longitudinal direction. The pieces can be separated by a gap in a lateral axis B, defining a lateral direction.

[0035] Each part comprises a tip facing outward from the device. The tips 222, 232 project from the device 1 and can be directed in the longitudinal direction.

[0036] The two tips 222, 232 are separated so as to define the ejection channel 280 between them.

[0037] The part 220, 230 also defines a reservoir channel 282 which is not defined by the tip 222, 232. The reservoir channel 282 is further inside the device 1 than the ejection channel 280. In other words, the reservoir channel 282 is located between the ejection channel 280 and the body of the device 150.

[0038] For example, the part 220, 230 may comprise a press 224, 234 which is an extension of material of the tip in the longitudinal direction. The press 224, 234 is located between the tip and the body of the device 150. The press 224, 234 extends longitudinally opposite a fixed part and is separated from the fixed part by a lateral gap along the lateral axis B. This lateral gap makes it possible to define the reservoir channel 282.

[0039] In the case where the device comprises two incision pieces, and as illustrated in figures 1 and 2, each piece 220, 230 comprises a press 224, 234. The presses 224, 234 are located between the tip and the body of the device 150. The presses 224, 234 extend longitudinally opposite one another and are separated by a lateral gap along the lateral axis B. This lateral gap makes it possible to define the reservoir channel 282.

[0040] The reservoir channel and the ejection channel are connected so that a liquid in the reservoir channel can be transported into the ejection channel and vice versa. In the example of Figure 1, in the longitudinal extension, the reservoir channel is in the longitudinal extension of the ejection channel.

[0041] The part 220, 230 is mounted to move relative to the body of the device 1. In particular, the part 220, 230 can move between a neutral position and an injection position.

[0042] When moving from the neutral position to the injection position, a volume of the ejection channel 280 is increased and a volume of the reservoir channel 282 is decreased. For example, the transition from the neutral position to the injection position may be accomplished by moving the tip 222, 232 away from the fixed portion and moving the presses 224, 234 closer to the fixed portion. The tip in the neutral position may define a wall parallel to the longitudinal axis.

[0043] In the case where the device comprises two incision parts, each part 220, 230 is mounted to move relative to the body of the device 1, between a neutral position and an injection position. The transition from the neutral position to the injection position can be done by moving the tips 222, 232 apart and bringing the presses 224, 234 together. The tips in the neutral position can define a wall parallel to the longitudinal axis.

[0044] In the case where the device comprises three or more incision pieces, these are distributed according to angular sectors around the longitudinal axis A. They are located opposite each other, defining along the tips the ejection channel and further towards the inside of the device the reservoir channel. The pieces are all movable between a neutral position and an injection position. The transition from the neutral position to the injection position can be done by moving the different tips apart and bringing the presses together. Alternatively, the device comprises a plurality of these incision pieces, only a part of which is mounted movable relative to the device. This part of the pieces is movable between a neutral position and an injection position.

[0045] Different designs of parts mounted between a neutral position and an injection position are possible.

[0046] Pivot zone

[0047] For example, a part 220, 230 can be mounted to be mobile in rotation relative to the body 150 of the device thanks to a pivot zone 264, 274 which connects each incision part 220, 230 to the body 150.

[0048] The pivot zone allows rotation of the part 220, 230 mounted to rotate in relation to the body 150 in the transverse direction of the axis C. The pivot zone is located outside a separation plane passing through the ejection channel. In particular, this separation plane can be defined by the longitudinal axis A and by the transverse axis C.

[0049] The pivot zone 264, 274 is located relative to the separation plane between the ejection channel 280 and the reservoir channel 282. In particular, in the longitudinal direction, the pivot zone 264, 274 is located between the ejection channel 280 and the reservoir channel.

[0050] Thus positioned, the pivot zones allow a rotational movement of the parts relative to the body 150. This allows the tips to move away from or towards each other and the presses 224, 234 to move away from or towards each other. More precisely, when the tips move away from each other, the presses move towards each other and vice versa. In the case where the device comprises three (or more) incision parts, these are distributed according to angular sectors around the longitudinal axis A. Each part is centered around a part plane which passes through the longitudinal axis. The planes are distributed angularly in a regular manner around the longitudinal axis. Each part can then be mounted to be mobile in rotation relative to the body 150 in three directions (or more) which are located in the same plane of rotation perpendicular to the longitudinal axis A, each direction being orthogonal to the part plane associated with the part.

[0051] The pivot zone can be a pinched area of ​​material, that is, an area that has a sufficiently thin thickness of material that is sufficiently flexible to allow elastic rotation around the transverse direction. A pivot zone made in the form of a pinched area also makes it possible to define the neutral position as a default position to which the parts will tend to return in the absence of constraints.

[0052] Alternatively, the pivot zone may be achieved by any pivot connection along the transverse axis between the incision part and the body of the device. The device 1 may include a return part so that the parts return to the default neutral position, i.e. in the absence of constraints.

[0053] Referring to Figure 2, the body 150 of the device may comprise two lateral wings 160, 170 which extend longitudinally towards the tips. The lateral wings are separated and facing each other with respect to the separation plane defined by the longitudinal axis A and the lateral axis B.

[0054] The wings 160, 170 comprise at their longitudinal end points. Each tab 162, 172 is connected to an incision piece 220, 230 by a pivot zone 264, 274.

[0055] The tabs 162, 172 are laterally narrower than the wings 160, 170. The tabs extend longitudinally opposite the presses 224, 234. Each tab is laterally separated from a press by a gap of material 164, 174.

[0056] The gaps 164, 174 communicate with a housing 180 defined by an inner contour of the wings 160, 170, the presses being located inside the housing 180. The presses being separated laterally to provide the reservoir channel 282, the reservoir channel is in contact with the housing 180.

[0057] The device 1 is configured to move the parts 220, 230 when the tips are applied to the skin of a human or animal body, from the neutral position to the injection position so that a volume of the ejection channel 280 is increased and a volume of the reservoir channel 282 is decreased. In the case where the device comprises three (or more) incision parts, the body 150 of the device may comprise three (or more) wings which are distributed according to the same angular sectors as the sectors of the incision parts so as to place an incision part opposite a wing.

[0058] Different realizations of this movement when the points are applied to the skin are possible.

[0059] Levers

[0060] When each part 220, 230 is mounted to be able to rotate relative to the body 150 of the device by means of a pivot zone 264, 274 which connects each incision part 220, 230 to the body 150, the device may for example comprise levers 260, 270 configured to move the parts 220, 230 when the levers 260, 270 come to bear on the skin.

[0061] The levers 260, 270 are located on either side of the separation plane passing through the ejection channel.

[0062] Each lever 260, 270 is rigidly connected to a part 220, 230 according to a rigid zone 266, 276. The rigid zone is notably more rigid than the pivot zone 264, 274 under the exercise of a torque according to the transverse axis.

[0063] Each lever 260, 270 is also connected to the body 150 of the device 1 by one of the pivot zones 264, 274. In this case, each part is indirectly connected to the body 150 of the device via a rigid zone 266, 276, a lever 260, 270 and a pivot zone 264, 274.

[0064] The incision assembly 200 comprises, in addition to the incision pieces 220, 230, levers 260, 270.

[0065] Each lever extends from the rigid zone in the lateral direction B. The rigid zone may be located outside the separation plane and in the longitudinal direction opposite an upper part of the ejection channel close to the reservoir channel.

[0066] Each lever 260, 270 extends from the rigid area 266, 276 to an end 263, 273.

[0067] Each lever has an essentially flat outer surface 262, 272. This flat surface may be, in the neutral position of the parts, parallel to the lateral axis B and to the transverse axis C.

[0068] Lever locking means

[0069] Optionally, the device comprises means for locking the levers 260, 270. In particular, these locking means can fix the levers in the injection position, once the volume of the ejection channel has increased and the volume of the reservoir channel has decreased.

[0070] For this purpose and as seen in Figures 1 and 2, the incision device 1 comprises arms 265, 275 extending from ends 263, 273 of the levers 260, 270. These arms extend in the longitudinal direction away from the points 222, 232. These arms are located laterally opposite the wings 160 and 170 of the body 150 of the device 1. The longitudinal ends of the arms 265, 275 comprise hooks or lugs 267, 277 directed laterally towards the inside of the device 1, that is to say towards the longitudinal axis A.

[0071] Laterally opposite the hooks 267, 277 are complementary hooks 293, 295 included on the body 150 of the device 1. The complementary hooks may for example be associated with recesses 294, 296 of material in the lateral flanks of the wings 160, 170 recesses which have a shape complementary to the hooks 267, 277. These recesses produce, in correspondence with the hollows of the hooks 267, 277, projecting parts which are the complementary hooks 293, 295.

[0072] In the neutral position, the hooks 265, 275 are laterally outside the complementary hooks 293, 295.

[0073] Room walls

[0074] The part 220, 230 has a first wall 225, 235 which defines the reservoir channel 282. This first wall is located opposite a second wall of the fixed part of the device located opposite the part.

[0075] The first wall can have different shapes.

[0076] Preferably, the first wall 225, 235 has a shape complementary to the second wall of the device located opposite the first wall.

[0077] In the case where the device comprises two incision pieces and with reference to figures 1 to 4, the pieces 220, 230 have walls 225,

[0078] 235 facing each other, these walls defining between them the reservoir channel 282 and having complementary shapes. The walls 225, 235 may in particular be walls of the presses 224, 234 mentioned above.

[0079] In a first option of this first variant, the walls 225, 235 facing each other are straight. They are then preferably parallel to the longitudinal axis A or almost parallel to this axis. In a second option of this first variant, one of the two walls has a convex zone 228, 238 facing a concave zone 226,

[0080] 236 on the other of the two walls.

[0081] A convex area of ​​a first wall is understood here as an area rounded outwards, i.e. towards the second wall.

[0082] A concave area of ​​a first wall is understood here as an inwardly rounded area, i.e., a hollow area towards the inside of the first wall. With reference to FIG. 3, the area 226 of the wall 225 of the press 224 is a convex area curved towards the outside of the press 224. The area 226 is opposite the area 238 of the wall 235 of the press 234. The area 238 is a concave area curved towards the inside of the press 234.

[0083] Still in relation to Figure 3, the area 228 of the wall 225 of the press 224 is a concave area curved towards the inside of the press 224. The area 228 is opposite the area 236 of the wall 235 of the press 234. The area 236 is a convex area curved towards the outside of the press 234.

[0084] More specifically, the concavity and convexity mentioned may be limited to curvatures in the plane defined by the longitudinal axis A and the lateral axis B. In other words, the walls 225, 235 do not have curvature in the transverse direction which is perpendicular to the longitudinal direction (i.e. the direction of extension of the points) and to the lateral direction (i.e. the direction in which the points are spaced from each other). By limiting the curvature of the walls 225, 235 in the plane defined by the longitudinal axis A and the lateral axis B, the incision parts are easier to manufacture.

[0085] One of the two walls may have a convex zone and a concave zone facing respectively a concave zone and a convex zone of the other of the two walls. The walls have undulations around a main direction which may be the longitudinal direction. The walls have zig-zag shapes in the plane defined by the longitudinal axis A and the lateral axis B.

[0086] It should also be noted that the portion of the reservoir channel 282 toward the inside of the device has a very flared outlet. In other words, in the portion of the reservoir channel 282, as one moves away from the tips along the longitudinal axis, the walls defining the reservoir channel move away from each other rapidly. This very flared outlet defines a boundary at the liquid level. It would be very costly in terms of surface energy for the liquid to be located in this flared outlet. The further the liquid advances into this flared outlet, the greater the energy cost.

[0087] Superficial incision procedure

[0088] A device for injection into the skin by superficial incision as just presented makes it possible to implement a superficial incision method according to the invention.

[0089] With reference to figures 3 and 4, we will present a mode of implementation of this process.

[0090] In an optional preliminary step of loading the device, the tips of the device can be dipped into an active liquid (vaccine solution or allergy test liquid). In this way, a quantity of liquid is drawn by capillary action into the ejection channel and into the reservoir channel.

[0091] It should be noted that in the case where the walls defining the reservoir channel have one of a convex zone 228, 238 opposite a concave zone of the other of the two walls, this allows the reservoir channel to have a small lateral width so that more quantity of liquid 10 can be sucked into the reservoir channel.

[0092] Furthermore, the thickness of the incision pieces and in particular of the presses in the transverse direction of the transverse axis C is adjustable. This is chosen according to the volume of liquid that one wishes to suck into the reservoir channel when loading the device.

[0093] The capillary suction of the active liquid in the ejection channel and in the reservoir channel assumes a sufficiently small lateral gap between the tips and the presses. In this regard and with reference to FIG. 1, the device has a slot 104 which separates the device into two halves 108 and 110. The handle 100, when present, may in particular have the shape of a split clover in its innermost part of the device 1 along the longitudinal axis A. The slot 104 may, from the clover, pass through the entire device 1. The presence of the slot and the clover makes it possible, in particular during manufacturing by molding, to maximize the angular tightening of the two halves 108, 110 when the part cools at the end of the manufacturing process. This reduces the lateral gap between the tips and the presses. It is possible for this gap to take a predetermined nominal value by using stops 112 to limit the angular tightening.

[0094] It should be noted that the stops 106 make it possible to keep the halves 108 and 110 opposite each other without possible transverse deviation in the direction of the transverse axis C.

[0095] According to the method, the points 222, 232 of a device 1 as previously presented are applied to the skin P of a human or animal body.

[0096] The situation before the tips come into contact with the skin is illustrated in Figure 3. The parts 220, 230 are in the neutral position. In this position the internal walls of the tips are parallel to the longitudinal axis.

[0097] Before the tips contact the skin, the levers 260, 270 define outer surfaces 262, 272 perpendicular to the longitudinal axis.

[0098] The situation after the tips have contacted the skin is illustrated in Figure 4. The tips contact the skin P and sink into the epidermis. The outer surfaces 262, 272 of the levers 260, 270 contact the skin surface.

[0099] The application of the device to the skin causes a rotational torque which is applied to the incision assembly 200. While the outer surfaces 262, 272 are retained outside the skin according to a restoring force R which is directed towards the outside of the skin, the points are sufficiently sharp so as not to be retained by the skin. The restoring force of the skin on the incision assembly is not applied uniformly in a plane perpendicular to the longitudinal axis. This tends to rotate each incision piece and lever pair around the pivot zone associated with it according to torques C1 and C2 shown in Figure 4.

[0100] The ends 263, 273 of the levers 260, 270 are raised longitudinally towards the inside of the device and the points sink further into the epidermis, that is to say moving away from the device.

[0101] The incision pieces are rotated by the levers to the incision position. The tips 222, 232 move laterally outwards so that the ejection channel 280 widens. Simultaneously the presses 224, 234 move closer and come into contact with each other so that the reservoir channel 282 narrows. The injection position is reached.

[0102] In this regard, the use of complementary shapes of the walls defining the reservoir channel allows to further reduce the volume of the reservoir channel when moving from neutral position to injection position.

[0103] The liquid 10 initially contained in the reservoir channel leaves the reservoir channel, the volume of which decreases. The liquid does not escape through the flared portion. The liquid is expelled towards the ejection channel 280.

[0104] This ensures a greater amount of active product that penetrates the skin and avoids the situation where liquid is retained inside the device.

[0105] It should be noted that the surfaces 262, 272 ensure both that the tips 220 and 230 are fully inserted into the skin upon application and also that they do not penetrate too deeply into the tissues of the human or animal body.

[0106] If the device comprises means for locking the levers 260, 270, then when the levers 260, 270 are moved from the neutral position to the injection position, the hooks 267, 277 force the hooks 293, 295 to move inwards by elastic deformation. Once the hooks 267, 277 have passed through the hooks 293, 295, the hooks 293, 295 elastically return to their initial position and hold the hooks 267, 277 and consequently the levers 260, 270 in the injection position. This makes it possible to keep the tips 222, 232 apart when the device 1 is subsequently withdrawn and to prevent active liquid from being sucked back into the ejection channel 280.

Claims

CLAIMS 1. Device (1) for injection into the skin by superficial incision, the device (1) comprising an incision part (220, 230) comprising a tip (222, 232) oriented towards the outside of the device, the tip (222, 232) defining an ejection channel (280), the part defining a reservoir channel (282), the device (1) being configured to move the part when the tip is applied to the skin of a human or animal body, so that a volume of the ejection channel (280) is increased and a volume of the reservoir channel (282) is decreased.

2. Device according to claim 1 wherein the incision part (220, 230) is mounted movably relative to a body (150) of the device, the incision part (220, 230) comprising a press (224, 234) located between the tip (222, 232) and the body of the device (150), the press (224, 234) defining the reservoir channel (282).

3. Device according to claim 2 wherein the tip (222, 232) is located on a first side of a separation plane passing through the ejection channel (280), the incision part (220, 230) being mounted to be movable in rotation relative to a body (150) of the device according to a pivot zone (264, 274), the pivot zone being located outside the separation plane between the ejection channel (280) and the reservoir channel (282).

4. Device according to claim 3, in which the press (224, 234) is located inside a housing (180) defined by wings (160, 170) of the body of the device (150).

5. Device according to any one of claims 3 to 4 further comprising a lever (260, 270), the lever (260, 270) being located on the first side of the separation plane, the lever (260, 270) being rigidly connected to the part and the lever being connected to the body (150) of the device by the pivot zone (264, 274), the lever being configured to move the part (220, 230) when the lever (260, 270) comes to bear on the skin.

6. Device according to claim 2 comprising means (290) for locking the lever (260, 270).

7. Device according to claim 6 wherein the locking means (290) comprises complementary hooks (267, 277, 293, 295) on the body (150) of the device and on an arm (265, 275) extending from one end (263, 273) of the lever (260, 270).

8. Device according to any one of claims 1 to 7 wherein the part (220, 230) has a first wall (225, 235) which defines the reservoir channel (282), the first wall (225, 235) having a shape complementary to a second wall of the device located opposite the first wall.

9. Device according to claim 8 wherein one of the first wall and the second wall has a convex zone (228, 238) opposite a concave zone (226, 236) of the other of the walls.

10. A method of superficial incision in which a tip (222, 232) of a device (1) for injection into the skin by superficial incision is applied to the skin of a human or animal body, the application resulting in a reduction of a volume of a reservoir channel (282) and an increase of a volume of an ejection channel (280), the ejection channel being defined by the tip, so as to transport a liquid from the reservoir channel (282) into the ejection channel (280).

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