INJECTION DEVICE WITH MULTIPLE CANNULAS

Abstract

The present invention concerns an injection device for delivering a substance to the skin of a subject. The injection device is suitable for precise and even distribution of the substance to the skin and minimizing waste of injectable substance. The injection device comprises multiple cannulas, is connectable to standard syringes and particularly useful in dermatological treatments.

Claims

1-10. (canceled)

11. An injection cannula array device comprising a distribution chamber defined by a base end comprising a plurality of apertures for fluid communication from the distribution chamber to the outside, side walls connected to the base end, and a top end comprising an aperture for fluid communication from the distribution chamber to the outside, wherein said top end is connected to a fluid conduit for fluid communication through the aperture, and wherein the fluid conduit comprises a fluid conduit connector on the distal end from the distribution chamber, the fluid conduit connector suitable for connecting to a syringe, wherein the device further comprises: a plurality of cannulas, wherein each cannula is arranged for fluid communication with the respective plurality of apertures, and wherein each cannula extends from the respective aperture to a cannula tip distal from the base end outside the distribution chamber, wherein the base end comprises a skirt extending from the outer edge of the base end at least a part of the length of the plurality of cannulas, wherein the skirt is suitable for leaving a distinct guiding mark on a skin surface after the skirt has been pressed against said skin surface, wherein the cannula array device comprises: a piston arranged slidingly within the distribution chamber, wherein the piston is arranged sealingly to the side walls, and the piston comprises an aperture for fluid communication from the distribution chamber through the fluid conduit, wherein the piston is configured with a start position at the top end and an end position at the base end, and wherein the piston is connected to the fluid conduit and configured to travel from the start position towards the end position when a predetermined force is applied to the fluid conduit in the direction of the base end, wherein the plurality of cannulas are arranged in rows, with a distance D between each of the plurality of cannulas, and wherein there is a row of said plurality of cannulas adjacent to the side skirt, and wherein the distance from each cannula located adjacent to the skirt to the outer edge of said skirt is between ½ D×Cos 25°−½ D×Cos 35°, when measured at angle perpendicular to the skirt, and wherein the skirt extends between 5-90%, of the length of the plurality of cannulas.

12. The injection cannula array device according to claim 11, wherein the distribution chamber has an inner shape of an equilateral triangle in the plane of the base end.

13. The injection cannula array device according to claim 11, wherein the outer walls of the skirt comprises five surfaces, wherein said five surfaces is comprised of two connected long surfaces, each said surfaces connected to two respective corner surfaces at an end distal to the connection between the two long surfaces, and one short surface connected at each end to each respective corner surfaces, wherein the short surface is longer than the corner surfaces, and the long surfaces is longer than the short surface.

14. The injection cannula array device according to claim 11, wherein the side walls comprises a stop list protruding from the side walls proximal to the top end, into the distribution chamber, wherein the stop list is configured to engage with the piston, at the start position, thereby hindering travel of the piston out of the distribution chamber.

15. The injection cannula array device according to claim 11, wherein the top end comprises a top lid, wherein the top lid is arranged for covering the side walls and the piston, wherein the top lid comprises a top lid aperture for enclosing the fluid conduit, and wherein the top lid is configured to be separated into at least two parts along a line traversing the top lid aperture.

16. The injection cannula array device according to claim 15, wherein the top lid is configured to be separated into 3 parts.

17. The injection cannula array device according to any of the claims 15-16, wherein the fluid conduit comprises a stop ring protruding from the outside of the fluid conduit, wherein the stop ring is arranged to engage the top lid, thereby preventing movement of the fluid conduit and securing the piston in the start position when the top lid is covering the side walls and the piston.

18. The injection cannula array device according to claim 17, wherein the stop ring has a diameter suitable for a tight fit with the side walls when the piston travel from the start position towards the end position, and wherein the stop list is configured with recesses for allowing the stop ring to pass by and into the distribution chamber.

19. The injection cannula array device according to claim 18, wherein the top end comprises guiding pins for guiding the stop ring into the distribution chamber.

20. The injection cannula array device according to claim 15, wherein the distribution chamber comprises a ventilating opening for evacuating air from the distribution chamber prior to injecting a patient.

21. A method for obtaining even distribution of an injection fluid by use of the injection cannula array device according to claim 1, comprising the steps A. connecting the injection cannula array device to a syringe containing injection fluid B. inserting the needles into the skin of a patient and contacting the skin of a patient with the skirt by pressing the device against the skin of the patient with sufficient force for the skirt to leave a temporary line in the shape of the skirt on the skin surface of the patient, C. delivering a predetermined volume of injection fluid from the syringe, D. removing the injection cannula array device, E. spotting the temporary line in the skin surface of the patient, F. moving the injection cannula array device and aligning an outer surface of the skirt to the temporary line on the skin surface of the patient, G. optionally repeating step A.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0058] FIG. 1 is a side view of the injection cannula array device. A connected syringe is not shown.

[0059] FIG. 2 is bottom view of the device, showing the skirt and the cannula tips arranged with a distance D between them, and also showing that the distance from a cannula adjacent to the skirt to the outer edge of the skirt is ½ D×Cos 30°.

[0060] FIG. 3A-3C shows different options for patterns of injection points for the cannulas when a practitioner administers doses using the skirt for lining up all injections at a distance D between injections.

[0061] FIG. 4A-4F shows some different possibilities for expanding patterns of injections where the distance is D between injections.

[0062] FIG. 5A-5E shows some possible number of cannulas of one injection device.

[0063] FIGS. 6A and 6B shows a top view and a side view, respectively, of the injection device with a top lid dividable in two parts

[0064] FIG. 7A shows a top view of the injection device where the top lid has been divided in two parts

[0065] FIG. 7B shows a side view of the injection device where the top lid has been divided in two parts and removed. The piston can be pushed down.

[0066] FIGS. 8A and 8B shows a top view of the injection device where top lid is dividable in 3 parts.

[0067] FIG. 9 shows a view from perspective where the top lid is dividable in three parts and there are guiding pins for guiding the stop ring into the distribution chamber shown.

[0068] FIGS. 10A and 10B shows a top view of the distribution chamber with a ventilating opening in open position in FIG. 10A and the closed position in FIG. 10B.

[0069] FIG. 11 Shows an exploded view of the assembly of the cannula plate with the base end and the protective cap.

[0070] FIGS. 12A and 12B shows the device connected to a syringe, ready for use.

[0071] FIG. 13 shows a top view of the device with the stop ring and the stop list recesses

DETAILED DESCRIPTION OF THE INVENTION

[0072] In the following, specific embodiments of the invention will be described in more detail with reference to the drawings. However, the invention is not limited to the embodiments and illustrations contained herein. It is specifically intended that the invention includes modified forms of the embodiments, including portions of the embodiments and combinations of elements of different embodiments. It should be appreciated that in the development of any actual implementation, as in any engineering or design project, specific decisions must be made to achieve the developer's specific goals, such as compliance with system and/or business-related constraints. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication and manufacture for the skilled person having the benefit of this disclosure.

[0073] FIGS. 1-5 shows an embodiment of an injection device 100 that is suitable for fluid connection to a syringe 151. The injection device comprises a distribution chamber 114 and a plurality of cannulas arranged in a triangular shape. The injection device 100 is suitable for administering an injection fluid 150 evenly and uniformly to an area of skin by providing triangular shaped patterns of injections on a subject as shown in FIGS. 3-5.

[0074] FIGS. 6-7 shows an embodiment of the injection device 100 comprising a top lid 113 that is dividable into 2 parts and a piston 120 that is slidingly and sealably arranged between the side walls 116 within the distribution chamber 114. After being divided the top lid 113 may be removed and the piston 120 may be pushed towards the base end for driving out any remaining injection fluid 150 within the distribution chamber 114.

[0075] FIGS. 8-9 shows an embodiment wherein the top lid 113 is dividable into 3 parts and the top end comprises 3 guiding pins 144 suitable for engaging with a stop ring 141 on a fluid conduit for guiding the piston 120 into the distribution camber 114.

[0076] FIGS. 10A, 10B shows an aspect of the injection device 100 with a ventilating opening 155 for evacuating entrapped air in the distribution chamber 116 in a closed position and an open position.

[0077] FIG. 11 shows an embodiment of the injection device that has a protective cap where a cannula plate 123 is to be fastened to the base end 118 prior to use. The distribution chamber 114 is typically sealed with a base end protective foil 127 which is removed before the cannula plate 123 is connected to the base end 118.

[0078] FIGS. 12A and 12B shows a ready to use injection device 100 according to the present invention.

[0079] The invention will now be explained in further detail with reference to FIG. 1-12:

[0080] The present invention is suitable for use in the treatment of skin and is for use with standard syringes for injections. The present invention comprises an array with a plurality of cannulas that are preferably identical and is configured to provide a plurality of standardized micro injections simultaneously. The present invention advantageously provides injections that are evenly distributed with a predetermined distance between injections and a predetermined depth of injection for each said injection.

[0081] In humans the epidermis is about 0.5-1.5 mm thick. Dermis is about 1.5-4 mm thick. The thickness of the layers varies for different parts of the human body, but generally have about the same thickness in everybody within a given age group. Beneath the dermis we find subcutis. Treatment by use of the present invention relates to delivery of injection fluid deep dermally or sub dermally.

[0082] The present invention is suitable for treatment of the skin with injection fluids comprising injectable types of substances that include deoxycholic acid, hyaluronic acid, botulinumtoxin, lidocaine, saline, hyaluronic acid filler, Non Animal Stabilized Hyaluronic Acid (NASHA), or calcium hydroxyapatite, poly-1-lactic acid, polyglycolic acid, collagen wrinkle filler, bovine collagen-containing polymethyl methacrylate, autogenous wrinkle filler, but are not limited thereto. The skilled person acknowledges that injectable fluids comprising other active ingredients may also be suitable.

[0083] FIG. 1 shows an exemplary embodiment of the injection device 100 according to the present invention, comprising a distribution chamber 114. The distribution chamber 114 is defined by a base end 118, side walls 116 and a top end 111. The base end 118 comprises a plurality of apertures 119 that is in fluid connection with a respective plurality of cannulas 115 with cannula tips 115′ for penetrating the skin of a subject.

[0084] The outer edge of the base end 118 comprises a skirt 125 that extends from the base end 118 at least a part of the length set up by the cannulas 115. The cannulas are arranged in a triangular pattern with a distance D between each of the cannulas 115. Rows of cannulas 115 located adjacent to the skirt with a distance ½ D×Cos 30° from the outer edge of the skirt 125. The outer edge of the skirt 125 is parallel to the outer side walls 116.

[0085] The top end 111 comprises an aperture 126 for fluid connection from the distribution chamber 114 to a fluid conduit 140 that is connected to said top end 111.

[0086] As shown in FIG. 1 the top end 111 comprises a piston 120 arranged slidingly within the distribution chamber 114. The piston 120 forms a sealing fit with the side walls 116. The piston comprises an aperture 126 that is connected to the fluid conduit 140 allowing for fluid connection from the distribution chamber 114 to the fluid conduit. The piston 120 and the fluid conduit 140 with the stop ring 141 and the fluid conduit connector 142 is in one piece.

[0087] The distribution chamber 114 comprises a stop list 117 which protrudes into the distribution chamber 114, perpendicular from the side walls into the distribution chamber 114 at the end of the side walls 116 distal from the base end 118. The stop list 117 is configured to engage with the piston 120 and prevent it from sliding out of the distribution chamber 114 when the lid 113 has been removed.

[0088] The fluid conduit comprises a stop ring 141 that is an annular protrusion extending perpendicular from and fixed to the fluid conduit 140.

[0089] The top end 111 further comprises a top lid 113 that is located between the piston 120 and the stop ring 141. The top lid 113 rests on the side walls 116 proximal to the fluid conduit 140. This configuration locks the piston 120 in a starting position (SP) at the stop list 116, wherein the distribution chamber 114 can accept injection fluid 150.

[0090] The top lid 113 comprises a top lid aperture 113′ for the fluid conduit 140 to pass therethrough.

[0091] The fluid conduit 140 comprises a fluid conduit connector 142 located distal to the top end 111. The fluid connector 142 is suitable for connecting the injection device 100 to a syringe 151. The fluid connector 142 is a Luer lock type connector, which is well known. In FIG. 1 the fluid conduit connector 142 is shown with a fluid conduit connector protector 143, which is a Luer lock protector.

[0092] The syringe 151 contains the injection fluid 150. When the piston of the syringe 151 is pushed down injection fluid flows through the injection device 100 and out of the cannulas 115.

[0093] When the piston of the syringe 151 is pushed until the piston of the syringe 151 reaches the syringe 151 bottom, all injection fluid 150 is purged from the syringe 151 and the flow of injection fluid 150 will stop. A rest volume of injection fluid 150 is trapped within the distribution chamber 114.

[0094] The top lid 113 is configured to be removed from the position between the stop ring 141 and the top of the side walls 116. Removal of the top lid 113 makes the piston 120 free to move in the direction of the base end 118.

[0095] When the top lid 113 is removed and a force is applied to the piston 120, the piston 120 moves from a starting position (SP) at the stop list 117 to an end position (EP) at the base end 118 and thereby forcing the rest volume of injection fluid 150 out of the distribution chamber 114 through the cannulas 115.

[0096] As best shown in FIG. 7A the top lid 113 is in one embodiment configured to be split in two parts 113a for removing the top lid 113. FIG. 7B shows the injection device 100 where the top lid 113 is removed and the piston 120 is free to move into the distribution chamber 114.

[0097] FIG. 8A shows another embodiment of the injection device 100 where the top lid 113 is configured to be split into three parts 113b. As shown in FIGS. 8A, 8B and 9 the injection device comprises guiding pins 144 protruding from the edge of the top end 111 parallel to the side walls 116. The guiding pins engages with the stop ring 140 for secure guiding the initial movement of the piston 120 into the distribution chamber 114, avoiding any side to side movement and securing vertical movement of the piston 120 into the distribution chamber 114.

[0098] FIGS. 10A and 10B shows an embodiment of the injection device 100 comprising a ventilating opening 155 in an open position and closed position respectively. The distribution chamber 114 comprises a closing mechanism 156 arranged on a hinge 154 for securing a ventilating closure 157. The ventilating opening is located at the corner of the triangular distribution chamber 114 where two long surfaces 160 is connected and allows for evacuating air through the ventilating opening 155 and filling the distribution chamber 114 completely with injection fluid 150. When evacuating air from the distribution chamber 114 the ventilating opening must face up such that any air in the distribution chamber 114 gathers in the corner comprising the ventilating opening 115. The ventilating opening 155 is closed by operating the closing mechanism 156 when the distribution chamber 114 is full of injection fluid 150 and thereby closing the distribution chamber 114 which is now completely filled with injection fluid 150.

[0099] As shown in FIG. 11 in one embodiment of the injection device 100 the base end 118 is sealed with a protective foil 127. The injection device 100 is connected to a syringe 151 containing injection fluid 150 and turned so the base end 118 is vertical and the ventilating opening 155 faces up. The distribution chamber 114 is filled completely as air is evacuated and the distribution chamber 114 is then sealed as the ventilating opening 155 is closed. The base end 118 is then turned facing up before the protective foil 127 is removed.

[0100] The plurality of cannulas 115 are provided on a separate cannula plate 123. The cannulas 115 are protruding from cannula plate 123 at the opposite side of the cannula tips 115′ and align with the base end apertures 119 to provide a fluid connection between the cannula tips 115′ and the distribution chamber 114 when the cannula plate 123 is connected to the base end 118. This allows for providing the option of choosing sets of different size of cannulas 115 without needing to replace the entire injection device 100. The base end 118 is configured with female cannula plate connectors 121 for accepting male cannula plate connectors 122 located on the cannula plate 123. When the male cannula connector 122 is clicked in place in the female cannula connector 121 the cannula plate 123 is connected firmly to the base end 118.

[0101] FIG. 11 further shows a protective cap 135 comprising a plurality of protective cap spacers 136. The protective cap 135 is fastened on the cannula plate 123 with protective cap connectors 137 which are configured to engage a cannula plate recess 124 for securing the protective cap 135 to the cannula plate 123. The protective cap spacers 136 are a little longer than the cannulas 115 as measured from the cannula plate 123 to the cannula tips 115′ thus protecting the sharp, delicate cannula tips 115′ from damage as well as protecting a user from unintentional stings from cannulas 115 prior to use of the device. The cannula tips 115′ cannot contact the protective cap 135, when the protective cap 135 is connected to the cannula plate 123.

[0102] As shown in FIGS. 2, 9 12A and 12B the outer relief of the skirt 125 and the outer relief of the side walls 116 is configured with a diamond shape. The shape is substantially triangular comprising two connected long surfaces 160, wherein each of the two connected long surface 160 is connected to two respective corner surfaces 161 at the respective ends distal to the connection between the two long surfaces 160 and one short surface 162 connected at each end to the respective corner surfaces 161. The corner surface 161 is ½ D long, and has an inner angle of 120° towards the two adjacent surfaces.

[0103] The injection device comprises a cannula array surface 128 at the base end of the cannulas 115. The cannula array surface 128 is flat. This allows for exact injection depth to be decided prior to the treatment by the practitioner since the cannulas 115 will not penetrate the skin any deeper than the length of the cannulas'115 protrusion from the cannula array surface 128 The flat surface of the cannula array 128 effectively stops the cannulas' 115 penetration when the flat cannula array surface 128 is pressed against the skin of a person being treated.

[0104] As shown in FIG. 2 the cannulas 115 are arranged with a distance D between each cannula 115. The cannulas 115 adjacent to the skirt 125 are located a distance ½ D×Cos 30° from the outer edge of the skirt 125. The outer edge of the skirt 125 is configured to leave a temporary visible line in the patients skin after an injection to a patient, where the injection device is pressed against the patients skin in order to achieve penetration of all the cannulas 125 into the desired depth of the patients skin. The temporary line in the patient's skin can advantageously be used as a means for lining up the next injection. By moving and placing the skirt 125 of the injection device adjacent to the temporary line a second injection is given while sustaining the distance D between all injection points by cannulas 125. This is due to that the cannulas 115 adjacent to the skirt 125 are located a distance ½ D×Cos 30° from the closest outer edge of the skirt 125, when measured at an angle perpendicular to the closest outer edge of the skirt 125. Placing the skirt 125 directly adjacent to the temporary line in a patient's skin will yield a distance ½ D+½ D=D between adjacent injection points. This is given, since the cannulas 115 adjacent to the skirt 125 of two adjacent injection points forms patterns of equilateral triangles where the sides measures D when two adjacent administrations are aligned as shown in FIGS. 3A-3C.

[0105] The distance D may vary according to the needs of the specific skin treatment to be given.

[0106] The skin area to be treated can be expanded by administering multiple injections to a patient. Each time aligning the injection device 100 by using the temporary line left in the patient's skin by the skirt 125 which have been pressed onto the skin.

[0107] FIGS. 3A-3C shows how the administrations can be aligned to secure even and uniform distribution by keeping the distance between each injection site of a cannula at a distance D. The diamond shape with the corner surfaces 161 will be of help. When a new administration is to be applied the injection device may be rotated in 3 different ways. [0108] The pointed corner where the two long surfaces 160 are connected are aligned with where the short side 161 and the corner side 162 are connected, as shown in FIG. 3A [0109] When administration is given with short sides 161 adjacent to each other, the new administration is aligned at the extension line of a long side 160 from the prior administration. There are two possible ways to do this as shown in FIGS. 3B and 3C.

[0110] FIGS. 4A-4F shows examples of how the administration of active ingredient can be expanded to larger areas of skin in a patient while keeping the even and uniform distance D between each injection point by each cannula 115.

[0111] FIG. 5A-5E shows that the number of cannulas 115 can be scaled to the needs of a specific treatment. This also allows for scaling the size of the area that is to be treated. As shown in FIG. 5A-5E the device may comprise for example 3, 6, 10, 15 or 21 cannulas, but a skilled person would acknowledge that this is not meant to be limiting and that the injection device may comprise 28, 37, etc cannulas 115 arranged in the shown triangular shape.

[0112] The injection device 100 is therefore suitable for administering an injection fluid 150 evenly and uniform to an area of skin by providing triangular shaped patterns of injection sites as shown in FIGS. 3-5.

[0113] In one embodiment the invention relates to a method for obtaining even distribution of an injection fluid 150 by use of the injection cannula array device 100 according to claim, comprising the steps of [0114] A. connecting the injection cannula array device 100 to a syringe 151 comprising injection fluid 150 [0115] B. inserting the needles into the skin of a patient and contacting the skin of a patient with the skirt 125 by pressing the device 100 against the skin of the patient with sufficient force for the skirt 125 to leave a temporary line in the shape of the skirt 125 on the skin surface of the patient, [0116] C. delivering a predetermined volume of injection fluid 150 from the syringe 151, [0117] D. removing the injection cannula array device 100, [0118] E. spotting the temporary line in the skin surface of the patient, [0119] F. moving the injection cannula array device 100 and aligning an outer surface of the skirt 125 to the temporary line on the skin surface of the patient, [0120] G. optionally repeating step A

[0121] The method can further relate to by use of the injection cannula array device 100, [0122] wherein the method further comprises the steps of [0123] H. removing the top lid 113 [0124] I. applying a force to the fluid conduit 140 for pushing the piston 120 to the base end 113, thereby emptying the distribution chamber 114.

[0125] It is appreciated that certain features of the invention, which, for clarity, have been described above in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which, for brevity, have been described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

TABLE-US-00001 Table of references: 100 Injection device 111 Top end 113 Top lid 113′ Top lid aperture 113a Top lid part 113b Top lid part 113c Top lid dividing line 114 Distribution chamber 115 Cannula 115′ Cannula tip 116 Side wall 117 Stop list 118 Base end 119 Base end aperture 120 Piston 121 Female cannula plate connector 122 Male cannula plate connector 123 Cannula plate 124 Cannula plate recess 125 Skirt 126 Aperture 127 Base end protective foil 128 Cannula array surface 130 Stop list recess 135 Protective cap 136 Protective cap spacer 137 Protective cap connector 140 Fluid conduit 141 Stop ring 142 Fluid conduit connector 143 Fluid conduit connector protector 144 Guiding pins 150 Injection fluid 151 Syringe 154 Hinge 155 Ventilating opening 156 Ventilating opening closing mechanism 157 Ventilating opening closure 160 Long surface 161 Corner surface 162 Short surface