Device for injection into skin through superficial incision with movable incision member

Abstract

A device (1) for injection into the skin through a superficial incision, the device (1) comprising an incision member (220, 230) comprising a tip (222, 232) oriented towards the exterior of the device, the tip (222, 232) defining an injection channel (280), the member defining a reservoir channel (282), the device (1) being configured to move the member when the tip is applied to the skin of a human or animal body, the volume of the injection channel (280) is increased and the volume of the reservoir channel (282) is reduced.

Description

Technical Field

[0001] The present invention relates to the field of devices for superficial incisions of the skin of the human or animal body, in particular for diagnosing allergies. Skin allergy diagnostic tests are often referred to as prick tests. Background Art

[0002] Allergy diagnostic testing is a medical examination involving the superficial penetration of small droplets of an allergenic product into the upper part of the epidermis of the human or animal body, for example into the forearm, to test the reactivity of the person or animal to the product.

[0003] In practice, after a drop of product is placed on the skin of the human or animal body, the skin is pierced with a sharp device through the drop to allow the product to penetrate the skin, and then 15 to 20 minutes are waited before interpreting the skin reaction.

[0004] These test devices carry the risk of false negative errors, i.e. the risk of incorrectly reporting that an allergic individual is not allergic when the test product has not penetrated or has not penetrated sufficiently into the skin.

[0005] Incisor devices containing vaccine solutions are also available on the market, which are capable of incising the skin and simultaneously permeating the vaccine into the skin.

[0006] These vaccine devices present a risk of non-delivery of the vaccine when the vaccine solution does not penetrate or does not penetrate sufficiently into the skin.

[0007] For both types of devices, the active product (ie, allergen product or vaccine solution) is likely retained in the device by surface tension between the test product and the walls of the device.

[0008] Therefore, there is a need for a device for superficial incisions of the skin of the human or animal body that allows for adequate penetration of active products into the skin. Summary of the invention

[0009] One object of the present invention is to propose a device for superficial incisions of the skin of the human or animal body which allows sufficient penetration of an active product into the skin.

[0010] The object of the present invention is achieved by means of a device for injecting into the skin through a superficial incision, the device comprising an incision component, the incision component comprising a tip oriented toward the outside of the device, the tip defining an injection channel, the component defining a reservoir channel, the device being configured to move the component when the tip is applied to the skin of a human or animal body so that the volume of the injection channel increases and the volume of the reservoir channel decreases. The device comprises a reservoir channel and an injection channel defined by the tip. The device can be changed by moving the component so that the volume of the injection channel increases and the volume of the reservoir channel decreases. Thus, the active product initially in the reservoir channel can be transported to the injection channel and ultimately reaches the skin incised by the tip. The amount of active product that penetrates into the skin increases.

[0011] Such a device is advantageously and optionally supplemented by the following different features, alone or in combination:

[0012] a tip located on a first side of a separation plane passing through the injection channel, the cutout member being mounted to be rotatable relative to the body of the device along a pivot region located outside the separation plane between the injection channel and the reservoir channel;

[0013] a lever located on a first side of the separation plane, the lever being rigidly connected to the component and the lever being connected to the body of the device via a pivoting area, the lever being configured to move the component when the lever is in contact with the skin;

[0014] - a member for locking the control rod;

[0015] - the locking member comprises complementary hooks on the body of the device and on an arm extending from one end of the control rod;

[0016] - a component having a first wall defining a reservoir channel, the first wall having a shape complementary to a second wall of the device located opposite the first wall;

[0017] One of the first and second walls has a convex area opposite to a concave area of ​​the other wall.

[0018] The present invention also relates to a method of superficial incision, wherein the tip of a device for injecting into the skin through a superficial incision is applied to the skin of a human or animal body, the application causing the volume of a reservoir channel to decrease and the volume of an injection channel to increase, the injection channel being defined by the tip to transfer liquid from the reservoir channel to the injection channel. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Other features and advantages of the present invention will appear from the following description, which is merely illustrative and not restrictive and which must be read with reference to the accompanying drawings, in which:

[0020] Figure 1 is a schematic diagram of a first perspective view of a cutting device according to a first embodiment of the present invention;

[0021] Figure 2 shows an enlarged detail view of a portion of one end of the incision device;

[0022] Figure 3 and Figure 4 The device is shown at two consecutive steps for skin incision. DETAILED DESCRIPTION

[0023] refer to Figures 1 to 4 , the main embodiment of the invention will be described. These figures show a device 1 for injection into the skin through a superficial incision.

[0024] A longitudinal axis A is defined, defining a longitudinal direction, along which the surface cutting device 1 extends.

[0025] Cut-out parts

[0026] The device 1 comprises at least one cut-out member 220, 230 at a longitudinal end of the device.

[0027] The device 1 may include Figure 1 Two cutout members 220, 230 are shown, or more cutout members may be present.

[0028] As an option, the device may comprise a handle 100 , ie a manual gripping area, at the other longitudinal end of the device 1 .

[0029] The incision members 220 , 230 form part of an incision assembly 200 of the device 1 .

[0030] The device may be described as being comprised of an incision assembly 200 including incision members 220, 230 and a body 150 of the device which may include a handle 100 if applicable.

[0031] For example, the cutout part extends in longitudinal direction opposite to the fixed part of the device 1. The part may be spaced apart from the fixed part by a gap on a lateral axis B defining a lateral direction. Such a lateral gap between the tip and the fixed part allows to define an injection channel.

[0032] The lateral axis B is perpendicular to the longitudinal axis A. A third axis or transverse axis C orthogonal to the longitudinal axis A and the lateral axis B may be defined.

[0033] In the case where the device comprises two cutout components, and if Figure 1 and Figure 2As shown, these components extend relative to each other in the longitudinal direction. These components may be separated by a gap on a lateral axis B defining a lateral direction.

[0034] Each component has a tip facing outwards from the device.The tips 222, 232 protrude from the device 1 and may be pointed in a longitudinal direction.

[0035] The two tips 222, 232 are spaced apart to define a spray passage 280 therebetween.

[0036] The components 220, 230 also define a reservoir channel 282 that is not defined by the tips 222, 232. The reservoir channel 282 is further inside the device 1 than the injection channel 280. In other words, the reservoir channel 282 is located between the injection channel 280 and the body 150 of the device.

[0037] For example, the components 220, 230 may include an extrusion 224, 234, which is an extension of the tip material in the longitudinal direction. The extrusion 224, 234 is located between the tip and the body 150 of the device. The extrusion 224, 234 extends longitudinally opposite the fixed portion and is separated from the fixed portion by a lateral gap along the lateral axis B. The lateral gap makes it possible to define a reservoir channel 282.

[0038] Where the device comprises two cut-out components, and if Figure 1 and Figure 2 As shown, each component 220, 230 includes an extrusion 224, 234. The extrusion 224, 234 is located between the tip and the body 150 of the device. The extrusions 224, 234 extend longitudinally relative to each other and are separated by a lateral gap along the lateral axis B. The lateral gap allows the reservoir channel 282 to be defined.

[0039] The reservoir channel and the injection channel are connected so that the liquid in the reservoir channel can be transferred to the injection channel, and vice versa. Figure 1 In the example, in the longitudinal extension, the reservoir channel is located in the longitudinal extension of the injection channel.

[0040] The components 220, 230 are mounted to be movable relative to the body of the device 1. In particular, the components 220, 230 are movable between an intermediate position and an injection position.

[0041] By traveling from the neutral position to the inject position, the volume of the injection channel 280 increases and the volume of the reservoir channel 282 decreases.

[0042] For example, the transition from the intermediate position to the injection position can be achieved by moving the tip 222, 232 away from the fixed portion and by moving the extrusion portion 224, 234 closer to the fixed portion. The tip in the intermediate position can define a wall parallel to the longitudinal axis.

[0043] Where the device comprises two cut-out components, each component 220, 230 is mounted to move between an intermediate position and an injection position relative to the body of the device 1. Transition from the intermediate position to the injection position may be achieved by moving the tips 222, 232 apart and by moving the extrusions 224, 234 closer together. The tips in the intermediate position may define a wall parallel to the longitudinal axis.

[0044] In the case where the device comprises three or more cutout components, these cutout components are distributed in an angular sector around the longitudinal axis A. They are positioned facing each other, thereby defining an injection channel along the tip and a reservoir channel further towards the interior of the device. These components can all be moved between an intermediate position and an injection position. The transition from the intermediate position to the injection position can be achieved by moving the different tips apart and by moving the extrusion parts closer together. In a variant, the device comprises a plurality of these cutout components, wherein only a portion of the cutout components is mounted to be movable relative to the device. This portion of the component can be moved between an intermediate position and an injection position.

[0045] Different embodiments of the components mounted between the intermediate position and the injection position are possible.

[0046] Pivot Area

[0047] For example, the components 220 , 230 may be mounted so as to be rotatable relative to the body 150 of the device by means of a pivot region 264 , 274 connecting each cutout component 220 , 230 to the body 150 .

[0048] The pivoting region allows rotation of the components 220, 230 which are mounted for rotational movement relative to the body 150 in a transverse direction of the axis C. The pivoting region is located outside a separation plane passing through the injection channel. In particular, the separation plane can be defined by the longitudinal axis A and by the transverse axis C.

[0049] The pivot regions 264, 274 are positioned relative to the separation plane between the injection channel 280 and the reservoir channel 282. In particular, in the longitudinal direction, the pivot regions 264, 274 are located between the injection channel 280 and the reservoir channel.

[0050] Positioned this way, the pivot region allows rotational movement of the components relative to the body 150. This allows the tips to separate or move toward each other, and the extrusions 224, 234 to separate or move toward each other. More specifically, when the tips separate, the extrusions move toward each other, and vice versa.

[0051] In the case where the device includes three (or more) cutout components, these cutout components are distributed in angular sectors around the longitudinal axis A. Each component is centered on a component plane passing through the longitudinal axis. These planes are evenly distributed angularly around the longitudinal axis. Each component can then be mounted so that the component can be rotated relative to the body 150 in three (or more) directions, these three directions are located in the same rotational plane perpendicular to the longitudinal axis A, and each direction is orthogonal to the component plane associated with the component.

[0052] The pivot region may be a contraction region of the material, i.e. a region with a sufficiently thin material thickness which is flexible enough to allow elastic rotation about the transverse direction. Making the pivot region in the form of a contraction region also allows the intermediate position to be defined as a default position to which the component will tend to return in the absence of constraints.

[0053] In variations, the pivoting region may be created by any pivoting connection along the transverse axis between the cut-out member and the body of the device.The device 1 may comprise a return member so that the member returns by default (ie in the absence of constraint) to a neutral position.

[0054] Reference Figure 2 , the body 150 of the device may include two lateral wings 160, 170 extending longitudinally towards the tip. The lateral wings are spaced apart and face each other relative to a separation plane defined by the longitudinal axis A and the lateral axis B.

[0055] The wings 160, 170 comprise their longitudinal ends on the tip side. Each tongue 162, 172 is connected to the cutout part 220, 230 via a pivoting area 264, 274.

[0056] The tongues 162, 172 are laterally narrower than the wings 160, 170. The tongues extend longitudinally relative to the extrusions 224, 234. Each tongue is laterally separated from the extrusion by a gap 164, 174 in the material.

[0057] The gaps 164, 174 communicate with the housing 180 defined by the inner contours of the wings 160, 170, and the extrusion is located inside the housing 180. Since the extrusion is laterally separated to form the reservoir channel 282, the reservoir channel is in contact with the housing 180.

[0058] The device 1 is configured to move the components 220, 230 from the intermediate position to the injection position when the tip is applied to the skin of the human or animal body, so that the volume of the injection channel 280 increases and the volume of the reservoir channel 282 decreases.

[0059] In case the device comprises three (or more) cutout members, the body 150 of the device may comprise three (or more) wings distributed along the same angular sector as the sector of the cutout members to position the cutout members opposite the wings.

[0060] Various embodiments of this movement are possible when the tip is applied to the skin.

[0061] Joystick

[0062] When each component 220, 230 is mounted so that it can be rotated relative to the body 150 of the device by means of a pivot area 264, 274 connecting each incision component 220, 230 to the body 150, the device may, for example, include a control rod 260, 270 that is configured to move the components 220, 230 when the control rod 260, 270 contacts the skin.

[0063] The control rods 260, 270 are located on either side of a separation plane passing through the injection channel.

[0064] Each control lever 260, 270 is rigidly connected to a component 220, 230 in a rigid region 266, 276. The rigid region is in particular more rigid than the pivoting region 264, 274 in the event of a torque applied along the transverse axis.

[0065] Each lever 260, 270 is also connected to the body 150 of the device 1 by one of the pivoting areas 264, 274. In this case, each component is indirectly connected to the body 150 of the device via the rigid area 266, 276, the lever 260, 270 and the pivoting area 264, 274.

[0066] In addition to the cutout members 220 , 230 , the cutout assembly 200 also includes control rods 260 , 270 .

[0067] Each control rod extends from the rigid region in a lateral direction B. The rigid region may be located outside the separation plane and opposite in the longitudinal direction to an upper portion of the injection channel close to the reservoir channel.

[0068] Each control rod 260 , 270 extends from a rigid region 266 , 276 to an end 263 , 273 .

[0069] Each lever has a substantially flat outer surface 262, 272. This flat surface may be parallel to the lateral axis B and the transverse axis C in the intermediate position of the components.

[0070] Locking lever member

[0071] Optionally, the device comprises means for locking the control rods 260, 270. In particular, these locking means can fix the control rods in the injection position once the volume of the injection channel increases and the volume of the reservoir channel decreases.

[0072] For this purpose, Figure 1 and Figure 2 As shown, the incision device 1 comprises arms 265, 275 extending from the ends 263, 273 of the control rods 260, 270. These arms extend in the longitudinal direction away from the tips 222, 232. These arms are 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 interior of the device 1 (i.e. towards the longitudinal axis A).

[0073] 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 side edges of the wings 160, 170, which recesses have a shape complementary to the hooks 267, 277. These recesses form protruding parts of the complementary hooks 293, 295, corresponding to the hollows of the hooks 267, 277.

[0074] In the intermediate position, the hooks 265 , 275 are laterally outside the complementary hooks 293 , 295 .

[0075] Parts Wall

[0076] The components 220, 230 have a first wall 225, 235 defining a reservoir channel 282. The first wall is positioned opposite a second wall of a fixed portion of the device positioned opposite the components.

[0077] The first wall may have different shapes.

[0078] Preferably, the first wall 225, 235 has a shape complementary to a second wall of the device located opposite the first wall.

[0079] In the case where the device comprises two cut-out parts, reference Figures 1 to 4 , the components 220, 230 have mutually opposite walls 225, 235, which define between them the reservoir channel 282 and have complementary shapes. The walls 225, 235 can in particular be the walls of the above-mentioned extrusions 224, 234.

[0080] In a first option of this first variant, the walls 225, 235 opposite each other are straight. They are 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 area 228, 238 opposite to the concave area 226, 236 of the other of the two walls.

[0081] A convex region of the first wall is understood here to be a region which is rounded towards the outside, ie towards the second wall.

[0082] A concave region of the first wall is understood here to be a region which is rounded towards the inside, ie which is concave towards the inside of the first wall.

[0083] refer to Figure 3 , the region 226 of the wall 225 of the extrusion portion 224 is a convex region that curves toward the outside of the extrusion portion 224. The region 226 is opposite to the region 238 of the wall 235 of the extrusion portion 234. The region 238 is a concave region that curves toward the inside of the extrusion portion 234.

[0084] Still refer to Figure 3 , the region 228 of the wall 225 of the extrusion portion 224 is a concave region that curves toward the inside of the extrusion portion 224. The region 228 is opposite to the region 236 of the wall 235 of the extrusion portion 234. The region 236 is a convex region that curves toward the outside of the extrusion portion 234.

[0085] More precisely, the concavity and convexity mentioned can limit the curvature in the plane defined by the longitudinal axis A and the lateral axis B. In other words, the walls 225, 235 have no curvature in the transverse direction perpendicular to the longitudinal direction (i.e. the direction in which the tips extend) and perpendicular to the lateral direction (i.e. the direction in which the tips are spaced apart 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, it is easier to manufacture the cutout component.

[0086] One of the two walls may have a convex area and a concave area opposite to the concave area and convex area of ​​the other wall, respectively. The wall has corrugations around a main direction, which may be a longitudinal direction. The wall is serrated in a plane defined by the longitudinal axis A and the lateral axis B.

[0087] It should also be noted that the portion of the reservoir channel 282 that faces the interior of the device has a relatively large flared outlet. In other words, in this portion of the reservoir channel 282, the walls defining the reservoir channel rapidly move away from each other as one moves away from the tip along the longitudinal axis. This highly flared outlet defines the limits of the liquid level. From a surface energy perspective, positioning the liquid in the flared outlet is very lossy. The more liquid that enters the flared outlet, the greater the energy consumption.

[0088] Superficial incision process

[0089] The device just proposed for injection into the skin through a superficial incision makes it possible to implement the superficial incision method according to the invention.

[0090] refer to Figure 3 and Figure 4 , the implementation mode of this method will be given.

[0091] In an optional preliminary loading step of the device, the tip of the device can be immersed in an active liquid (vaccine solution or allergy test liquid). In this way, a certain amount of liquid is sucked into the injection channel and into the reservoir channel by capillary action.

[0092] It should be noted that where the wall defining the reservoir channel has a convex region 228, 238 opposite a concave region of the other of the two walls, this allows the reservoir channel to have a smaller lateral width so that more liquid 10 can be drawn into the reservoir channel.

[0093] Furthermore, the thickness of the cutout member and in particular the thickness of the squeeze portion in a direction transverse to the transverse axis C is adjustable. This is selected according to the volume of liquid that is desired to be drawn into the reservoir channel when the device is loaded.

[0094] Capillary suction of the active liquid into the injection channel and into the reservoir channel assumes a sufficiently small lateral gap between the tip and the squeeze portion. Figure 1 , the device has a slot 104 which divides the device into two halves 108 and 110. The handle 100, when present, may in particular have the shape of a cloverleaf split along the longitudinal axis A at the innermost part of the device 1. The slot 104 may pass through the entire device 1 from the cloverleaf. The presence of the slot and the cloverleaf in particular makes it possible to narrow the angle of the two halves 108, 110 to the greatest extent during manufacturing by molding, when the parts cool at the end of the manufacturing process. This reduces the lateral clearance between the tip and the extrusion. This clearance can assume a predetermined nominal value by using a stop 112 to set the limit of the angle narrowing.

[0095] It should be noted that the stop 106 makes it possible to maintain the halves 108 and 110 relative to each other without a possible lateral deviation in the direction of the transverse axis C.

[0096] According to the method, the tip 222, 232 of the device 1 as described above is applied to the skin P of the human or animal body.

[0097] Before the tip contacts the skin, Figure 3 Components 220, 230 are in an intermediate position. In this position, the inner wall of the tip is parallel to the longitudinal axis.

[0098] Prior to contact of the tip with the skin, the control rods 260, 270 define an outer surface 262, 272 that is perpendicular to the longitudinal axis.

[0099] What happens when the tip contacts the skin? Figure 4 shown.

[0100] The tip contacts the skin P and penetrates into the epidermis. The outer surfaces 262, 272 of the control rods 260, 270 contact the surface of the skin.

[0101] Application of the device to the skin causes a rotational torque to be applied to the incision assembly 200. Although the outer surfaces 262, 272 are held outside the skin according to the restoring force R directed to the outside of the skin, the tip is sharp enough not to be held by the skin. The push back of the skin on the incision assembly is not uniform in a plane perpendicular to the longitudinal axis. This is intended to make each incision component and control rod pair rotate about its associated pivot area according to Figure 4 Pairs C1 and C2 shown rotated.

[0102] The ends 263, 273 of the control rods 260, 270 are longitudinally raised toward the interior of the device, and the tips penetrate further into the epidermis, for example by moving away from the device.

[0103] The cutout member is rotated to the cutout position by the control rod. The tips 222, 232 move laterally outward, causing the injection channel 280 to expand. At the same time, the squeeze parts 224, 234 approach each other and contact each other, causing the reservoir channel 282 to decrease. The injection position is reached.

[0104] In this regard, the use of complementary shapes of the walls defining the reservoir channel makes it possible to further reduce the volume of the reservoir channel during the transition from the intermediate position to the injection position.

[0105] The liquid 10 initially contained in the reservoir channel leaves the reduced volume reservoir channel. The liquid does not overflow through the flared portion. The liquid is discharged toward the injection channel 280.

[0106] In this way, a greater amount of active product is ensured to penetrate into the skin and liquid retention inside the device is avoided.

[0107] It should be noted that surfaces 262, 272 both ensure that tips 220 and 230 are fully inserted into the skin during application, and also ensure that they do not penetrate too deeply into tissue of the human or animal body.

[0108] If the device comprises means for locking the control rods 260, 270, the hooks 267, 277 cause the hooks 293, 295 to move inwards by elastic deformation during the movement of the control rods 260, 270 from the intermediate position to the injection position. Once the hooks 267, 277 have passed over the hooks 293, 295, the hooks 293, 295 elastically return to their initial position and keep the hooks 267, 277 and the control rods 260, 270 in the injection position. This makes it possible to keep the tips 222, 232 spaced apart when the device 1 is subsequently withdrawn and to prevent the active liquid from being drawn back into the injection channel 280.

Claims

1. A device (1) for injecting into the skin through a superficial incision, the device (1) comprising an incision component (220, 230), the incision component comprising a tip (222, 232) oriented toward the outside of the device, the tip (222, 232) defining an injection 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 so that the volume of the injection channel (280) increases and the volume of the reservoir channel (282) decreases.

2. The device according to claim 1, wherein: The cutout member (220, 230) is movably mounted relative to the body (150) of the device, the cutout member (220, 230) including an extrusion (224, 234) between the tip (222, 232) and the body (150) of the device, the extrusion (224, 234) defining the reservoir channel (282).

3. The device according to claim 2, wherein: The tip (222, 232) is located on a first side of a separation plane passing through the injection channel (280), and the cutout member (220, 230) is mounted so as to be rotatable relative to the body (150) of the device along a pivot area (264, 274) located outside the separation plane between the injection channel (280) and the reservoir channel (282).

4. The device according to claim 3, wherein: The extrusion portion (224, 234) is located inside a housing (180) defined by the wing portions (160, 170) of the device body (150).

5. The device according to any one of claims 3 and 4 further comprises a control rod (260, 270), the control rod (260, 270) being located on a first side of the separation plane, the control rod (260, 270) being rigidly connected to the component and the control rod being connected to the body (150) of the device via the pivot area (264, 274), the control rod being configured to move the component (220, 230) when the control rod (260, 270) is in contact with the skin.

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

7. The device according to claim 6, wherein: The locking member (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. The device according to any one of claims 1 to 7, wherein: The component (220, 230) has a first wall (225, 235) defining 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. The device according to claim 8, wherein: One of the first wall and the second wall has a convex region (228, 238) opposite a concave region (226, 236) of the other wall.

10. A method for surface incision, wherein: The tip (222, 232) of a device (1) for injecting into the skin through a superficial incision is applied to the skin of a human or animal body, the application causing the volume of a reservoir channel (282) to decrease and the volume of an injection channel (280) to increase, the injection channel being defined by the tip to transport liquid from the reservoir channel (282) to the injection channel (280).

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