Patent Application
20230173193
The present invention relates to 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.
Treatments for cosmetic enhancement including dermatology are used to restore or improve the shape and looks of the human skin. Over the years, healthcare professionals have developed numerous treatments including deep cutaneous and subcutaneous injection. Commonly known subcutaneous injection include filler injections and botulinum toxin injections. Sub-dermal injections are regarded as minimally invasive procedures for changing the aesthetics of the human skin. Common areas where the subcutaneous injection material is injected are the areas on the face, neck, hands, breast and buttocks, resulting in a change in their contours, resulting in a restored, younger-looking appearance.
Commercially available injectable types of substances include deoxycholic acid, hyaluronic acid, botulinumtoxin, lidocaine, saline, hyaluronic acid filler, (E.g., calcium hydroxyapatite, poly-1-lactic acid, polyglycolic acid), collagen wrinkle filler, bovine collagen-containing polymethyl methacrylate, autogenous wrinkle filler, but are not limited thereto.
Hyaluronic acid is a common ingredient in skin care products. Hyaluronic acid is a normal ingredient in the intercellular space in human skin and is used as a dermal filler in cosmetic surgery. It is typically injected using a classic sharp, thin hypodermic needle, also called a micro-cannula.
A common method for administering a substance to the skin of a human subject is to use a device for injection. Typically, a syringe with a cannula is used. For cosmetic treatment this practice may not be well suited because a large number of injections are usually given in one treatment. It is also often critical for obtaining a good result that the substance to be injected is administered with an even distribution both with regards to distance between the injections and the depth of the injections in the area of skin that is treated. When using conventional syringe and cannula equipment such treatments are laboursome and demands great precision, concentration and patience for producing good results.
Some efforts have been made to provide a device for improving the administration of substances to the skin.
US2003/0208167 A1 discloses a microneedle device for administering a substance across or into the skin. The device includes a substrate with a reservoir which is in connection with a plurality of microneedles suitable for injection into the skin. The microneedles may have different shapes and lengths and the device is suitable for controlling the depth of injections by pushing the substrate onto the skin of a patient. There is no mention on how to evenly distribute the injections.
US20180264204 describes a needle injection array which comprises a fluid manifold configured to direct fluid from a syringe to arrive at the tip of the needles simultaneously. The needle injection array disclosed may be configured to secure a equal dose of fluid volume through the needles to an injection site.
Other commercial products are on the market. Restylane Skinbooster comprises hyaluronic acid in a syringe with a single cannula which are 1.2-1.3 mm long and has a diameter of 27-30G. The product is for administering the hyaluronic acid to a skin area through micro-injections. When the device is used hand-held, it is up to the practitioner to set the depth of injection and the distance between them.
A device with the trade name “Mesogun” can be used with a skinbooster injection device. It is possible to fix the depth of injection to a predetermined depth. “Mesogun” is moved manually and it is difficult to obtain standardized distance between injections.
A device called “DermaPen” is also available on the market. This device has 9-12 needles that are not hollow cannulas. The substance to be administered is applied to the skin surface of a subject before the skin is perforated by the “DermaPen”. This result in doses that are hard to predict and the cosmetic effect on the skin is somewhat unpredictable.
The devices mentioned above do not provide convenient means for administering a substance to the skin of a subject in a uniform an even manner.
Furthermore, they let expensive substance for injection to go to waste after use, because rest volumes of injection fluid may be left behind when cannula arrays are used.
It is therefore an object of the present invention to provide an injection device suitable for use in skin treatment that is configured for providing doses of a substance to the skin, wherein the doses are evenly distributed in the skin area that is to be treated.
It is also an object of the present invention to provide a device suitable for minimizing the waste of the substance to be administered.
Finally, it is an object of the present invention to provide a method for even administration to an area of skin.
The present invention is set forth and characterized in the main claims, while the dependent claims describe other characteristics of the invention.
In one embodiment the invention concerns 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.
In a second embodiment the invention concerns 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 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.
The fluid conduit connector may be of the “Luer lock”-type, a conical connecter or other connector means well known to the skilled person.
In one aspect the invention concerns the injection cannula array device wherein the skirt extends between 5-90%, 10-80%, 10-70%, 10-60%, 20-50% or 30-50% of the length of the plurality of cannulas.
In one aspect the invention concerns the injection cannula array device according to any of the preceding claims, 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.
In one aspect of the invention the plurality of cannulas is arranged in a triangular pattern.
In one aspect of the invention the distribution chamber has a triangular shape.
In one aspect of the invention the distribution chamber has an equilateral triangular shape.
In one aspect the invention relates to the injection cannula array device 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°, or between ½ D×Cos 29°−½ D×Cos 31° or ½ D×Cos 30°, when measured at angle perpendicular to the skirt.
In another aspect the invention relates to the injection cannula array device, wherein the distribution chamber has an inner shape of an equilateral triangle in the plane of the base end.
In one aspect the invention concerns the injection cannula array device, wherein the outer walls of the skirt comprises 5 surfaces, wherein said 5 surfaces is comprised of 2 connected long surfaces, each said surfaces connected to 2 respective corner surfaces at an end distal to the connection between the two long surfaces, and 1 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.
In one aspect the corner surface is ½ D long.
In one particular aspect the invention concerns the injection cannula array device, comprising 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 (SP) at the top end and an end position (EP) at the base end, and wherein the piston is connected to the fluid conduit and configured to travel from the start position (SP) towards the end position (EP) when a predetermined force (N) is applied to the fluid conduit in the direction of the base end.
The skilled person understands that this aspect will work with either the first or the second embodiment of the invention, ie. with or without the base end being configured with a skirt for leaving a guiding mark on the skin surface.
In one aspect of the invention the piston has a triangular shape.
In one aspect of the invention the piston has an equilateral triangular shape.
In one aspect the invention relates to the injection cannula array device, 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 (SP), thereby hindering travel of the piston out of the distribution chamber.
In another aspect the invention relates to the injection cannula array device, 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.
In one aspect the invention relates to the injection cannula array device, wherein the top lid is configured to be separated into 3 parts.
In another aspect of the invention the top end comprises guiding pins for guiding the stop ring into the distribution chamber.
In one aspect the invention relates to the injection cannula array device, 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 (SP) when the top lid is covering the side walls and the piston.
In yet another aspect the invention concerns the injection cannula array device, wherein the stop ring has a diameter suitable for a tight fit with the side walls when the piston travel from the start position (SP) towards the end position (EP), and wherein the stop list is configured with recesses for allowing the stop ring to pass by and into the distribution chamber.
In one aspect the invention concerns the injection cannula array, wherein the distribution chamber comprises a ventilating opening for evacuating air from the distribution chamber prior to injecting a patient. The ventilating opening is preferably located the corner of the distribution chamber where the two long surfaces are connected. The ventilating opening may be closable with a hatch or a lid or other closing means forming a water and air tight seal. The ventilating opening may in one configuration comprise a one way valve for evacuating air from the distribution chamber.
In one embodiment the present invention relates to a method for obtaining even distribution of an injection fluid by use of the injection cannula array device, comprising the steps
The skilled person acknowledges that a practitioner can exchange an used or empty syringe for new one as many times as it is needed to complete a treatment of a predetermined area of skin.
In a final aspect the invention relates to the method by use of the injection cannula array device, wherein the method further comprises the steps of
“Cannula” as used herein is to be understood as a hollow needle for use in medical procedures such as injections and infusions.
“Array” is to be understood as an arrangement or pattern of cannulas in an apparatus or device.
“Distribution chamber” as used herein is to describe a hollow space within the device suitable for distributing an injection fluid to a plurality of cannulas.
“Substance for injection” and “injection fluid” is used herein as equivalent and refers to a fluid that is suitable for injection in a human or animal with an injection device.
“Fluidly connected” or “in fluid communication” means that the connection allows gas, air, steam and liquid fluid to enter from one component to another component of the device.
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.
The invention will now be explained in further detail with reference to
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.
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.
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.
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.
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.
As shown in
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.
The fluid conduit comprises a stop ring 141 that is an annular protrusion extending perpendicular from and fixed to the fluid conduit 140.
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.
The top lid 113 comprises a top lid aperture 113′ for the fluid conduit 140 to pass therethrough.
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
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.
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.
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.
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.
As best shown in
As shown in
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.
As shown in
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.
As shown in
The distance D may vary according to the needs of the specific skin treatment to be given.
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.
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
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
The method can further relate to by use of the injection cannula array device 100,
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20200546 | May 2020 | NO | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/062485 | 5/11/2021 | WO |
