Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3286—Needle tip design, e.g. for improved penetration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/64—Proteins; Peptides; Derivatives or degradation products thereof
  • A61K8/65—Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
  • A61K8/73—Polysaccharides
  • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin
  • A61Q19/08—Anti-ageing preparations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00747—Dermatology
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00792—Plastic surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
  • A61B2017/3454—Details of tips
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/10—Hair or skin implants
  • A61F2/105—Skin implants, e.g. artificial skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
  • A61K2800/87—Application Devices; Containers; Packaging
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
  • A61K2800/91—Injection
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/04—Skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/06—Head
  • A61M2210/0625—Mouth

Definitions

• the present invention is generally directed toward a hypodermic needle for the injection of dermal fillers.
• Dermal fillers are gel-like materials that are injected into the skin to provide facial volume, augment facial features, and fill in facial wrinkles.
• Commonly used dermal fillers include hyaluronic acids, collagens, and biosynthetic polymers.
• a dermal filler for use in the lip region is commonly called a lip filler.
• a typical lip filler procedure may proceed as follows. prior to injection of dermal / lip filler, a topical anaesthetic will be applied to the lips. The topical anaesthetic will numb the lips to remove or reduce pain and ensure the process is made as comfortable as possible. If the recipient has an allergy to the relevant topical anaesthetic, a nerve block injection may instead be made to numb the lips.
• the lips should be numb; dermal filler will then be injected into the relevant parts of the lips, potentially including the edges of the lips (vermillion border), the curve in the centre of the upper lip (Cupid’s bow) and the oral commissures (corners of the mouth).
• anaesthetic as the case may be
• skin 1 and tissue layers most relevant to a dermal filler procedure include: the epidermis 2 - being the outermost layer of the skin 1 and forming the waterproof, protective wrap over the body’s surface.
• the epidermis 2 - being the outermost layer of the skin 1 and forming the waterproof, protective wrap over the body’s surface.
• the epidermis 2 provides a barrier to infection and helps the skin 1 regulate body temperature.
• the epidermis 2 contains no blood vessels and is nourished by diffusion from the dermis.
• the epidermis 2 can vary in thickness depending upon location, but in the lip-region has a thickness of approximately 60 pm; the dermis 3 - being the layer beneath the epidermis 2 and tightly connected to the epidermis 2 by a basement membrane.
• the dermis 3 contains nerve endings that provide the skin 1 with a sense of touch and heat, as well as hair follicles, sweat glands, sebaceous glands, apocrine glands, lymphatic vessels and blood vessels.
• Blood vessels in the dermis 3 provide nourishment and waste removal from its own cells as well as from the stratum basale of the epidermis 2.
• the dermis 3 can vary in thickness depending upon location, but in the lip region typically has a thickness in the range of 600-1000pm; and the hypodermis 4 is also known as sub-cutaneous tissue. Lying below the dermis 3, the hypodermis 4 does not form part of the skin 1.
• the purpose of the hypodermis 4 is to attach the skin 1 to underlying bone and muscle as well as supplying it with blood vessels and nerves.
• the hypodermis 4 consists of loose connective tissue, adipose tissue and elastin.
• the dermis 3 represents the layer into which dermal filler is most commonly injected. Injecting into the superficial to mid dermis 3 in particular can stop the skin folding process which creates wrinkles, and the dermis 3 also provides the most superficial traction or support, meaning that injection into the dermis 3 can help to correct skin 1 weaknesses and the effects of gravity.
• the dermis 3 is also generally considered a relatively safe location for injection, as the dermis 3 is not close to significant blood vessels. Generally, when undertaking a lip filler procedure, the dermis 3 is selected as the intended layer for injection of dermal filler.
• Dermal filler injections are traditionally made with a short needle, and many commercial fillers are in fact sold in packs comprising two such needles for use.
• the benefits of a needle are considered to be that: a needle punctures the skin and as many tissue planes of the face as required to get to the intended layer in which dermal filler is to be deposited; a needle can be injected into precise locations on the face and is therefore suitable for delicate work.
• a needle While the ability of a needle to puncture tissue planes may be seen as an advantage in certain situations, using a needle also presents risks. There is for example a risk that the needle will pierce blood vessels lying below the dermis, causing bruising. More seriously, a needle may inject filler into a blood vessel, leading to a vascular occlusion. Less seriously, but nevertheless not desired, the angle at which a needle is inserted can mean that dermal filler is injected at different depths and within different layers within or below the skin, leading to an uneven cosmetic result whereby some dermal filler is deposited too deep and some too superficial - in turn leading to lumpy, undesirable cosmetic results.
• FIG. 2A shows a needle 5 passing through the epidermis 2, the dermis 3 and the hypodermis 4.
• injection of dermal filler 6 as the needle 5 passes out of the skin can lead to deposition of dermal filler 6 at various depths including within the hypodermis 4.
• lips are commonly injected using vertical injections from the vermillion border 9 aimed at the body (wet/dry junction) 14 of the lip. Also shown in Figure 3 is the submucosa 8, the outer lip 10, the sebaceous gland 11, the muscle layer 12 and the salivary glands 13. As exemplified in Figure 4, use of a needle 5 according to the prior art may be seen to increase the risk that a needle 5 may puncture tissue planes and lead to dermal filler 6 being deposited at different depths and within different layers within or below the skin 1 , leading to uneven cosmetic results.
• a cannula is longer, thinner, flexible, and comprises a blunt end.
• a needle is first used to puncture the skin, creating an entry point for the cannula to pass through. Due to its blunt tip and flexible configuration, a cannula is less likely to piece blood vessels. Rather, a cannula is more likely to stay within a particular dermal layer.
• the length and flexibility of a cannula further mean that a cannula requires less entry points into the skin to deliver dermal filler across the treatment area.
• a cannula is seen as allowing less control and accuracy in areas that require precision, for example when treating the fine “smoker’s lines” around the lips where a light hand is required to deliver tiny amounts of dermal filler quite superficially.
• a needle for injecting dermal filler into the dermis comprising: a proximal end for connection to a syringe; and a distal end comprising a sharpened tip, wherein the needle comprises a curved region between the proximal end and the distal end.
• the vertex angle of the curved region is between 130° and
• the needle comprises a first straight region extending from the proximal end to the curved region.
• the first straight region comprises a length of between 4mm and 18mm, optionally between 4mm-12rnm, optionally between 4mm-8mm.
• the curved region terminates at the distal end.
• the vertex angle of the curved region is between 160° and 180°, optionally between 165° and 175°.
• the degree of bend of the curved region is between 5° and 50°, optionally between 10° and 45°, further optionally between 15° and 40°, and even further optionally between 20° and 35°.
• the curved region comprises an arc length of between 8mm and 18mm, optionally between 11 mm and 16 mm, optionally between 12 mm and 14 mm.
• the needle comprises a second straight region extending from the curved region to the distal end.
• second straight region comprises a length of between 7mm and 12 mm, optionally between 8mm-11mm, optionally between 9mm-10mm.
• the vertex angle of the curved region is between 140° and 160°
• the curved region comprises an arc length of between 2mm and 5mm, optionally between 3mm-4mm.
• the tip comprises an outer facing bevel.
• the tip comprises an inner facing bevel.
• the needle comprises an outer diameter of between 0.235mm and 0.362mm.
• the needle comprises an outer diameter of approximately 0.312 mm.
• the needle comprises a wall thickness in accordance with the ISO 6009:2016 wall standard definitions of regular-walled, thin-walled, extra thinwalled or ultra-thin walled.
• the needle comprises a wall thickness of less than 0.09mm, optionally between 0.05mm and 0.09mm.
• the wall thickness of the needle tapers toward the distal end along at least a portion of the length of the needle.
• the needle is composed of a non-toxic, non-corrosive, durable, material.
• the material of the needle is selected from stainless steel, titanium, cobalt chrome and platinum.
• the needle is composed of stainless steel.
• the needle is between approximately 25-gauge and approximately 32-gauge.
• the needle is approximately 30-gauge.
• the needle is packaged in a blister pack.
• a method comprising injecting dermal filler into the dermal layer of skin via a needle according to a first embodiment of the invention.
• the method comprises injecting the dermal filler into the lip or perioral area of the face.
• the method comprises injecting the dermal filler into the lips wherein the needle is inserted at (or close to) the vermillion border aiming toward the body (wet / dry border) of the lip.
• method comprises retrograde depositing dermal filler as the needle is being at least partially withdrawn from the skin.
• the method comprises anterograde depositing dermal filler as the needle is being inserted further into the skin.
• the method comprises injecting a bolus deposit of dermal filler whilst the needle is static.
• FIGURE 1 shows the layers of skin, including the epidermis, dermis and hypodermis.
• FIGURE 2 shows a needle according to the prior art injecting dermal filler into layers of the skin.
• FIGURE 3 shows components of a human lip.
• FIGURE 4 shows a needle according to the prior art injecting dermal filler into a human lip.
• FIGURE 5 shows a needle according to an embodiment of the present invention, injecting dermal filler into skin.
• FIGURE 6 shows a needle according to an embodiment of the present invention, injecting dermal filler into a human lip.
• FIGURE 7 shows the calculation of the curvature of the needle based on the arc length, chord length and vertex angle.
• FIGURE 8 shows various representations of needles according to embodiments of the present invention.
• FIGURE 9 shows various representations of a needle according to an embodiment of the present invention.
• FIGURE 10 shows various representations of a needle according to an embodiment of the present invention.
• FIGURE 11 shows the cross-sectional area of a needle having a ‘regular thickness’ wall, and a second needle having a ‘thin’ wall.
• FIGURE 12 shows photographs of two needles according to embodiments of the invention.
• Reference Numerals
• the invention relates to a curved needle for the injection of dermal fillers and other compounds into skin.
• the needle is configured for injection of dermal fillers into the lips and perioral area of a human face.
• Figures 3A and 3B show how a curved needle 5 according to embodiments of the invention may be used to reduce risks associated with needles of the prior art.
• a curved needle 5 i.e. a needle comprising a curved region
• the tip of the needle 7 will generally continue to follow the angle of entry into the epidermis 2, making it difficult to pass the needle 5 along through a layer of skin 1 without passing into another layer of skin.
• Figures 3A and 3B demonstrate a retrograde method of depositing dermal filler 6, in which the needle 5 is first inserted to a desired position (see Figure 3A), and dermal filler 6 is injected as the needle 5 is being (at least) partially withdrawn from the skin 1 (see Figure 3B).
• dermal filler 6 may be deposited using an anterograde method, in which dermal filler 6 is injected as the needle 5 is inserted into the skin 1.
• Each of the retrograde method and the anterograde method are considered linear threading’ or ‘tunnelling’ methods of deposition.
• An anterograde method may be commonly performed for tear troughs or the vermilion border because it allows the medical professional to better visualize the dermal filler tracking.
• a retrograde method may be commonly used to fill in deeper wrinkles (such as around the nasolabial folds and marionette lines) or to plump the lips.
• a curved needle 5 may be particularly suited for linear threading methodologies as discussed above, such a needle 5 may also be used in ‘multiple injection’ methods, such as the depot method, or more generally where a bolus deposit of dermal filler 6 is injected while the needle 5 is static.
• Figures 6A and 6B further show the utility of a curved needle 5 when injecting dermal filler 6 into the lips.
• a curved needle 5 it is believed that using a curved needle 5 according to embodiments of the invention enable the tip 7 of the needle 5 to follow the shape of the lip and pass along a desired skin layer, such as the dermis 3.
• a desired skin layer such as the dermis 3.
• this will further enable dermal filler 6 to be injected into a desired layer of lip skin to provide a desirable deposition of dermal filler 6, which would in turn reduce the risk of bruising, vascular occlusion and poor cosmetic results.
• the curvature of a needle 5 may be seen as approximating a segment of the circumference of a circle whereby the curvature comprises: an arc length 17, representing the distance along an arc between two end points, e.g. the distance along the curvature between points A and B, or the distance along the curvature between points C and D. a chord length 15, representing the distance along a line segment whose end points intersect the end points along an arc.
• a vertex angle 16 representing the vertex angle of an isosceles triangle which touches an arc at its endpoints (such that the entire chord length represents the hypotenuse of the triangle) and a point equidistant from the end points (such that the vertex angle touches the arc at this equidistant point).
• curvature of a needle by reference to terms such as ‘arc length’, ‘chord length’ and ‘vertex angle’, it is not intended that the curvature of the curved region is necessarily circular. Rather the curved region may adopt any generally curved shape such as a circular shape, an elliptical shape, a parabolic shape, a hyperbolic shape and for example any combination or combinations of the above.
• the terms ‘arc length’, ‘chord length’, and ‘vertex angle’ are to be construed in the context of a curved region as more generally representing the length of the curved region following the curve, without requiring the curved region to be circular or any other specific curved shape.
• degrees of bend simply relates to the extent of change in direction of the needle from the start of the curved region to the end of the curved region, measured in degrees such that: a straight region having no curvature would have a degree of bend of 0°; a curved region in which the direction of end of the curved region is at a right angle to the direction of the start of the curved region would have a degree of bend of 90°; and a curved region in which the direction of end of the curved region is parallel but opposite to the direction of the start of the curved region would have a degree of bend of 180°
• the curved region 19 of a needle 5 comprises: an arc length 17 of between 8mm and 18mm, optionally between 11 mm and 16 mm, further optionally between 12 mm and 14 mm; a vertex angle 16 of between 160° and 179°, optionally between 165° and 175°; a chord length 15 of between 9-11mm, and/or a degree of bend of between 5° and 50°, optionally between 10° and 45°, further optionally between 15° and 40°, and even further optionally between 20° and 35°.
• an arc length 17 of between 8mm and 18mm optionally between 11 mm and 16 mm, further optionally between 12 mm and 14 mm
• a vertex angle 16 of between 160° and 179°, optionally between 165° and 175°
• a chord length 15 of between 9-11mm, and/or a degree of bend of between 5° and 50°, optionally between 10° and 45°, further optionally between 15° and 40°, and even further optionally between 20° and 35°
• Figure 8A, Figure 8B and Figure 8C each show needles according to embodiments of the present invention, each comprising a curved region 19 and a first straight region 18, whereby: in Figure 8A, the needle 5 comprises: a first straight region 18 that is 6.5mm long; and a curved region 19 having a chord length 15 of 6.5mm and a vertex angle 16 of 165° (and a degree of bend of approximately 35°); in Figure 8B, the needle 5 comprises: a first straight region 18 that is 4mm long; and a curved region 19 having a chord length 15 of 9mm, a vertex angle 16 of 165° and a degree of bend of approximately 35° (in other words, the needle 5 of Figure 8A comprises a longer first straight region 18 and a shorter curved region 19 than that of Figure 8A, notwithstanding that the degree of bend is approximately the same); and in Figure 8C, a needle 5 is shown having a needle tip 7 with an outward facing bevel.
• the tip 7 of the needle 5 is ‘bevelled’ or ‘angled’ to provide a sharper edge for insertion into layers of the skin 1.
• the bevelled tip 7 shown in Figure 8C faces away from the curvature of the curved region 18, meaning that the tip 7 has an outward facing bevel.
• the tip 7 has an inward facing bevel whereby the bevel faces the direction of curvature of the curved region 19.
• the needle 5 may include more than one bevel, such as by incorporating a double bevel design which (without wishing to be bound by theory) may provide for less painful injection.
• Figure 9 shows a needle 5 according to embodiments of the invention comprising a first straight region 18, a curved region 19 and a tip 7 comprising an outward facing bevel.
• the straight region 18 is approximately 10mm long while the curved region 19 has a chord length 15 of approximately 9 mm, a vertex angle 16 of approximately 165° and a degree of bend of approximately 15°.
• Figure 9 also shows the outer diameter and inner diameter of the needle 5, whereby the outer diameter 22 is approximately 0.309mm and the inner diameter 21 is approximately 0.165mm (providing a wall thickness of approximately 0.072mm). This approximates a thin walled ‘30 gauge’ needle thickness profile.
• processes of providing a curved region 19 may slightly alter the wall thickness and diameter of the needle within and in the vicinity of the curved region 19.
• the process of providing a curved region 19 may reduce the diameter of the needle 5 in the curved region 19, or generally ‘flatten’ the cross-sectional shape of the needle 5 to provide a more elliptical cross-section.
• References to diameters, wall thicknesses and gauges are therefore to be construed as allowing for reasonable variability, particularly within and in the vicinity of the curved region 19, as a result of the production process.
• Figure 10 shows a needle 5 according to embodiments of invention comprising a first straight region 18, a curved region 19, a second straight region 20 and a tip 7 comprising an inward facing bevel.
• the length of the first straight region 18 is approximately 6mm
• the length of the second straight region 20 is approximately 6mm
• the chord length 15 of the curved region 19 is approximately 4mm
• the vertex angle 16 of the curved region 19 is approximately 150°
• the degree of bend is approximately 30°.
• Figure 10 also shows the outer diameter 22 and inner diameter 21 of the needle 5, whereby the outer diameter 22 is approximately 0.309mm and the inner diameter 21 is approximately 0.165mm (providing a wall thickness of approximately 0.072mm). This approximates a thin walled ‘30 gauge’ needle thickness profile.
• a needle 5 may comprise a standard thickness of between 25 gauge to 32 gauge, or a thin walled thickness profile of between 25 gauge to 32 gauge.
• Figure 11 contrasts a thin walled thickness profile against a standard thickness profile of a needle 5.
• the curved region 19 of a needle 5 comprising a second straight region 20 may have a shorter chord length 15 than may be found in a needle 5 not comprising a second straight region 20.
• a needle 5 may be composed of a non-toxic, non-corrosive, durable material, such as: stainless steel, titanium, cobalt, chrome or platinum.
• the needle 5 is composed of stainless steel.
• the needle 5 is composed of stainless steel 440, which enables the production of very sharp tips 7.
• Needles 5 may be manufactured according to any suitable process as understood by the person skilled in the art.
• a common process for the manufacture of straight needles involves tube drawing, whereby a tube is drawn through progressively smaller dies to produce the straight needle and the end of the needle is bevelled to create a sharp pointed tip.
• a straight needle may be bent to provide for a curved region 19 using a tool similar to a compression bending tool as used for larger pipes and tubes in the context of plumbing and like professions.
• the straight needle may be heated prior to bending to manage issues such as metal fatigue and the like which may affect the strength or other physical characteristics of the bent needle 5.
• a bent needle 5 may be utilised applying principles of rotary draw bending, mandrel bending, compression bending, or roll bending for example.
• methods of providing a curved region 19 which maintains the strength of the needle 5 and prevents or minimises any reduction of the diameter and wall thickness of the needle 5 in and around the curved region 19 are utilised.
• the proposed needle 5 will be packaged in a blister pack to provide a safe and convenient way to store the needle 5 due to the sharpness of the tip.
• the needle may be packaged with a curved or flexible cap or sheath adapted to conform the shape of the needle 5.
• the needle 5 may be packaged in a self-contained box shape container with a screw off hub cover to allow for syringe attachment.
• Embodiments of the invention are also directed to methods of injecting a dermal filler 6 using a needle 5 comprising a curved region 19 such as that described above.
• the present invention is directed to a method of injecting dermal filler 6 into the dermis layer 3 of the lips or perioral area of the face.
• the needle 5 is inserted at or close to the vermillion border 9 aiming toward the body (wet/dry) border of the lip.
• dermal filler 6 is injected as the needle 5 is partially withdrawn from the skin 1.
• dermal filler 6 is injected as the needle 5 is being inserted further into the skin 1 , and/or a bolus deposit of dermal filler 6 is injected whilst the needle 5 is static.
• Figure 12 shows prototypes of the proposed needles 5, the needles 5 comprising a Luer lock located at the proximal end of the respective needles 5.
• the disclosed and described needle 5 may be suitable for other applications not limited to the injection of dermal fillers 6. As such, unless the context otherwise requires use of the disclosed needle 5 need not be limited to use in the injection of dermal fillers 6 and other uses are possible.
• the disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Heart & Thoracic Surgery (AREA)
• Biomedical Technology (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Vascular Medicine (AREA)
• Surgery (AREA)
• Birds (AREA)
• Epidemiology (AREA)
• Diabetes (AREA)
• Gerontology & Geriatric Medicine (AREA)
• Dermatology (AREA)
• Pathology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Priority Applications (7)

Applications Claiming Priority (2)

Publications (1)

Family

ID=87347476

Family Applications (1)

Country Status (8)

Cited By (1)

Families Citing this family (1)

Citations (5)

Family Cites Families (2)

• 2023
  • 2023-01-19 CN CN202380021502.XA patent/CN118891011A/zh active Pending
  • 2023-01-19 AU AU2023209363A patent/AU2023209363A1/en active Pending
  • 2023-01-19 EP EP23742619.2A patent/EP4465911A4/en active Pending
  • 2023-01-19 WO PCT/AU2023/050024 patent/WO2023137516A1/en not_active Ceased
  • 2023-01-19 CA CA3249286A patent/CA3249286A1/en active Pending
  • 2023-01-19 US US18/730,354 patent/US20250161589A1/en active Pending
  • 2023-01-19 JP JP2024543216A patent/JP2025503815A/ja active Pending
  • 2023-01-19 KR KR1020247027347A patent/KR20240144942A/ko active Pending

Patent Citations (5)

Non-Patent Citations (4)

Also Published As

Similar Documents

Legal Events