Curved needles for dermal filling

Abstract

The present invention relates to a curved needle for injecting dermal fillers into the lip and perioral area.

Description

[Technical field]

[0001] The present invention relates generally to hypodermic needles for injecting dermal fillers. [Background technology]

[0002] Dermal fillers (also known as injectable fillers, facial fillers, or cosmetic fillers) are gel-like materials that are injected into the skin to give the face volume, enhance facial features, and fill in facial wrinkles. Commonly used dermal fillers include hyaluronic acid, collagen, and biosynthetic polymers. Dermal fillers come in a gel form that remains in place to fill in features and provide the desired volume.

[0003] The use of dermal fillers to add volume to the lips and mouth area of ​​the face is particularly common, the purposes of which include: Restoring lip size, keeping in mind that lips can become smaller or thinner with age; Correcting the shape of the lips to avoid asymmetry; Smoothing out wrinkles around the sides of the mouth; and Generally, to create the appearance of a smoother and fuller lip and mouth area.

[0004] Dermal fillers used in the lip area are commonly referred to as lip fillers. A typical lip filler procedure proceeds as follows: Prior to the injection of the dermal / lip filler, a local anesthetic is applied to the lips. The local anesthetic numbs the lips and eliminates or reduces pain, ensuring the procedure is as comfortable as possible. If the recipient has an allergy to the relevant local anesthetic, a nerve block injection is performed instead to numb the lips. Approximately 15-30 minutes after application or injection of the anesthetic (depending on the situation), the lips should be numb; Dermal filler is then injected into the relevant areas of the lips, which optionally include the edges of the lips (vermilion), the central curve of the upper lip (Cupid's bow), and the corners of the mouth (corners of the mouth). On average, approximately 1 mL of lip filler is injected into the lips; Ice packs may be applied to the lips throughout and after the procedure to minimize swelling and bruising.

[0005] As shown in FIG. 1, the skin 1 and tissue layers most relevant to dermal filler treatments include: Epidermis 2 - the outermost layer of skin 1, which forms a waterproof protective wrap over the surface of the body. Among other things, the epidermis 2 provides a barrier against infection and helps skin 1 regulate body temperature. The epidermis 2 does not contain blood vessels and is supplied with nutrients by diffusion from the dermis. The thickness of the epidermis 2 may vary in different places, but in the lip region it is approximately 60 μm thick; Dermis 3 - the layer beneath the epidermis 2, and is firmly bound to the epidermis 2 by a basement membrane. The dermis 3 contains nerve endings that give the skin 1 its sense of touch and heat, as well as hair follicles, sweat glands, sebaceous glands, apocrine glands, lymphatic vessels, and blood vessels. The blood vessels of the dermis 3 provide nutrients to and remove waste products from its own cells as well as the basal layer of the epidermis 2. The thickness of the dermis 3 may vary from place to place, but in the lip region it is typically in the range of 600-1000 μm thick; The hypodermis 4 is also known as sub-cutaneous tissue. The hypodermis 4 lies below the dermis 3 and does not form part of the skin 1. The purpose of the hypodermis 4 is to attach the skin 1 to the bones and muscles underneath, as well as to supply the bones and muscles with blood vessels and nerves. The hypodermis 4 consists of loose connective tissue, adipose tissue, and elastin.

[0006] Dermal fillers can be injected into various layers depending on the intended application, but the dermis 3 is the layer in which dermal fillers are most commonly injected. In particular, injection into the superficial to mid-layers of the dermis 3 can halt the process of skin plicating, which creates wrinkles, and the dermis 3 also provides the most superficial traction or support, meaning that injection into the dermis 3 helps to correct weaknesses in the skin 1 and the effects of gravity. The dermis 3 is generally considered to be a relatively safe site for injection because it is not in close proximity to any significant blood vessels. Generally, when performing lip filling procedures, the dermis 3 is the layer of choice for injection of dermal fillers.

[0007] Dermal filler injections are traditionally performed using short needles, and many commercial fillers are actually sold in packs containing two such needles for use. The advantages of needles are thought to be: The needle penetrates as many facial tissue planes as necessary to reach the desired layer where the dermal filler will be deposited; Needles are well suited for delicate procedures because they can be injected into precise locations on the face.

[0008] Although the ability of needles to puncture tissue planes may be considered an advantage in certain circumstances, there are also risks associated with the use of needles. For example, there is a risk that the needle will pierce a blood vessel beneath the dermis, resulting in subcutaneous bleeding. More seriously, the needle may inject filler into a blood vessel, which may cause vascular occlusion. Less seriously, but undesirably, depending on the angle at which the needle is inserted, the dermal filler may be injected at different depths and in different layers within or beneath the skin, with some dermal fillers being deposited too deep and some dermal fillers being deposited too shallow, leading to uneven cosmetic results and therefore to an uneven and undesirable cosmetic result.

[0009] This is illustrated in Figure 2, where Figure 2A shows needle 5 passing through epidermis 2, dermis 3, and subcutaneous tissue 4. As needle 5 exits the skin, dermal filler 6 is injected, which can result in deposition of dermal filler 6 at various depths, including within subcutaneous tissue 4, as shown in Figure 2B.

[0010] Referring to Figure 3, the lips are commonly injected using a vertical injection from the vermilion 9, targeting the body of the lip (wet / dry boundary) 14. Also shown in Figure 3 are the submucosa 8, outer lip 10, sebaceous glands 11, muscularis 12, and salivary glands 13. As illustrated in Figure 4, the use of a prior art needle 5 may be considered to increase the risk that the needle 5 will puncture a tissue plane and the dermal filler 6 will be deposited at different depths and in different layers within or beneath the skin 1, resulting in an uneven cosmetic result.

[0011] The use of existing needles, as currently discussed, may further limit the cosmetic effect of dermal filler procedures. As discussed above, dermal filler procedures are commonly used to impart facial volume and enhance facial features. In imparting facial volume, it is generally desirable to provide a rounded, plump shaped profile that reflects the rounded shape found on the human face, as opposed to providing a flat or square shaped filler profile, for example. Taking the lips as an example, FIG. 13A shows a human lip detailing the nodules 23, cupid's bow, and vermilion border 9. A typical dermal filling process fills the lower left and right nodules 23. In such a process, it is desirable to provide lower nodules that are rounded and plump, whereby the combined effect generally provides a "heart shape" across the two lower nodules 23. To enable this, it is desirable to deposit the dermal filler in a manner that results in a generally circular / circular bolus area at each lower nodule 23. Providing a circular / circular bolus area at each lower nodule is difficult to achieve with existing needles, which are generally suitable for insertion into and passing linearly along the dermal layer 3. That is, existing needles are suitable for injecting dermal filler into the dermis 3 in a straight line, thereby depositing a straight line of dermal filler. While such needles are suitable for providing a square or rectangular bolus, it is very difficult to obtain a generally circular bolus from a linear deposition of dermal filler, as illustrated in FIG. 13B.

[0012] 13C-13D further illustrate scenarios where deposition using existing needles can result in undesirable results. FIG. 13C illustrates the deposition of dermal filler along Cupid's bow. Depending on the facial and skin structure, it may be generally desirable to deposit a line of filler directly along Cupid's bow. As shown in FIG. 13C, providing a desirable line of filler can be quite difficult with existing needles, as such needles are suited to depositing dermal filler in a straight line. FIG. 13D illustrates the use of a vertical injection into the lower lip, which is commonly performed to "fill in" the lower lip to increase height and definition. Using existing injection needles, dermal filler is often deposited in a straight line, resulting in the opposite of the desired result of the deposition flattening the lower lip instead of providing a fuller, rounder effect.

[0013] Recently, it has become common to use a cannula to inject dermal fillers. Compared to the needles used in dermal filler treatments, the cannula is longer, thinner, more flexible, and has a blunt end. To use a cannula, a needle is first used to puncture the skin to create an entry point through which the cannula passes. Because of the blunt tip and flexible configuration of the cannula, it is less likely to pierce a blood vessel. Rather, it is more likely to remain within a particular skin layer. The length and flexibility of the cannula also means that the cannula requires fewer entry points into the skin to deliver dermal filler throughout the treatment area. However, the length and flexibility of the cannula can create its own drawbacks. Cannulas are considered to provide less control and precision in areas that require precision, such as when treating fine "smoker's lines" around the lips, where manual dexterity is required to deliver very small amounts of dermal filler very shallowly. Summary of the Invention

[0014] It would be desirable to develop new products for delivering dermal fillers that address one or more of the problems of existing technology, or at least provide a viable alternative to it.

[0015] According to a first aspect of the present invention, there is provided a needle for injecting a dermal filler into the dermis, comprising: a proximal end for coupling to a syringe; a distal end including a sharp tip; Equipped with A needle is provided that includes a curved region between a proximal end and a distal end.

[0016] In one embodiment, the apex angle of the curved region is between 130° and 179°.

[0017] In one embodiment, the needle includes a first straight region extending from the proximal end to a curved region.

[0018] In one embodiment, the first linear region comprises a length between 4mm and 18mm, optionally between 4mm and 12mm, optionally between 4mm and 8mm.

[0019] In one embodiment, the curved region terminates at the distal end.

[0020] In one embodiment, the apex angle of the curved region is between 160° and 180°, optionally between 165° and 175°.

[0021] In one embodiment, the bend degree 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°.

[0022] In one embodiment, the curved region comprises an arc length between 8mm and 18mm, optionally between 11mm and 16mm, optionally between 12mm and 14mm.

[0023] In one embodiment, the needle includes a second straight region extending from the curved region to the distal end.

[0024] In one embodiment, the second linear region comprises a length between 7 mm and 12 mm, optionally between 8 mm and 11 mm, optionally between 9 mm and 10 mm.

[0025] In one embodiment, the apex angle of the curved region is between 140° and 160°.

[0026] In one embodiment, the curved region comprises an arc length between 2mm and 5mm, optionally between 3mm and 4mm.

[0027] In one embodiment, the tip includes an outward bevel.

[0028] In one embodiment, the tip includes an inward bevel.

[0029] In one embodiment, the needle comprises an outer diameter of between 0.235 mm and 0.362 mm.

[0030] In one embodiment, the needle comprises an outer diameter of approximately 0.312 mm.

[0031] In one embodiment, the needle comprises a wall thickness conforming to the ISO 6009:2016 wall standard definitions of normal wall, thin wall, very thin wall, or ultra-thin wall.

[0032] In one embodiment, the needle comprises a wall thickness of less than 0.09 mm, optionally between 0.05 mm and 0.09 mm.

[0033] In one embodiment, the wall thickness of the needle tapers along at least a portion of the length of the needle towards the distal end.

[0034] In one embodiment, the needle is constructed from a non-toxic, non-corrosive, durable material.

[0035] In one embodiment, the needle material is selected from stainless steel, titanium, cobalt chrome, and platinum.

[0036] In one embodiment, the needle is constructed from stainless steel.

[0037] In one embodiment, the needle is between about 25 gauge and about 32 gauge. Optionally, the needle is about 30 gauge.

[0038] In one embodiment, the needles are packaged in a blister pack.

[0039] According to a second aspect of the present invention, there is provided a method comprising injecting a dermal filler into a dermal layer of the skin via a needle according to the first embodiment of the present invention.

[0040] In one embodiment, the method includes injecting a dermal filler into the lips or perioral area of ​​the face.

[0041] In one embodiment, the method includes injecting a dermal filler into the lips, where a needle is inserted into (or adjacent to) the vermilion, aiming at the body of the lip (wet / dry boundary).

[0042] In one embodiment, the method includes retrogradely depositing the dermal filler as the needle is at least partially withdrawn from the skin.

[0043] In one embodiment, the method includes antegrade depositing of the dermal filler as the needle is further inserted into the skin.

[0044] In one embodiment, the method includes injecting a bolus deposit of dermal filler while the needle is stationary.

[0045] Throughout this specification and the claims which follow, unless the context otherwise requires: The term "comprise", and variations thereof such as "comprises" and "comprising", are understood to include a stated integer or step or group of integers or steps but not to exclude other integers or steps or groups of integers or steps; The terms "a" or "an" are intended to mean one or more than one; The terms "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects or to establish a particular ranking of importance of their objects. [Brief description of the drawings]

[0046] [Figure 1] FIG. 1 is a diagram illustrating layers of skin, including the epidermis, dermis and subcutaneous tissue. [Diagram 2] FIG. 2 shows a prior art needle for injecting dermal filler into a layer of skin. [Diagram 3] FIG. 3 is a diagram illustrating the components of the human lip. [Figure 4] FIG. 4 shows a prior art needle for injecting dermal filler into a human lip. [Diagram 5] FIG. 5 illustrates a needle for injecting dermal filler into the skin according to an embodiment of the present invention. [Figure 6] FIG. 6 illustrates a needle according to an embodiment of the present invention for injecting dermal filler into a human lip. [Figure 7] FIG. 7 illustrates the calculation of needle curvature based on arc length, chord length, and apex angle. [Figure 8] FIG. 8 illustrates various representations of a needle according to an embodiment of the present invention. [Figure 9] FIG. 9 shows various representations of a needle according to one embodiment of the present invention. [Figure 10] FIG. 10 shows various representations of a needle according to one embodiment of the present invention. [Figure 11] FIG. 11 shows the cross-sectional area of ​​a needle having a "normal thickness" wall and a second needle having a "thin" wall. [Figure 12] FIG. 12 shows a photograph of two needles according to an embodiment of the present invention. [Figure 13A] Figure 13A shows the human lips detailing the tubercle, Cupid's ribbon, and vermilion border. [Figure 13B] FIG. 13B illustrates a human lip where dermal filler was deposited in a linear fashion using a straight needle. [Figure 13C] FIG. 13C illustrates a human lip with dermal filler injected with a straight needle along Cupid's bow. [Figure 13D] FIG. 13D shows a human lip where the dermal filler was deposited in a linear fashion using a straight needle, resulting in a flattened lower lip. [Figure 14A] FIG. 14A illustrates a human lip where dermal filler was deposited using a curved needle to facilitate a rounded bolus of dermal filler. [Figure 14B] FIG. 14B illustrates a human lip injected with dermal filler using a curved needle aligned with Cupid's bow. [Figure 14C] FIG. 14C illustrates a human lip where dermal filler was deposited using a curved needle to provide a rounder and fuller deposition of the dermal filler. [Explanation of symbols]

[0047] 1. Skin 2. Epidermis 3. Dermis 4. Subcutaneous tissue 5. Needle 6. Dermal Fillers 7. Needle Tip 8. Submucosa 9. Red lips 10. Outer lip 11. Sebaceous glands 12. Muscle layer 13. Salivary glands 14. Wet / dry boundary 15. String length 16. Vertical angle 17. Arc length 18. First linear region 19. Curved Areas 20. Second Linear Region 21. Inner diameter 22. Outside diameter 23. Nodules 24. Cupid's Bow 25. Dermal Filler Deposition DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] In general, the present invention relates to a curved needle for injecting dermal fillers and other compounds into the skin. In certain embodiments, the needle is configured to inject dermal fillers into the lips and perioral area of ​​the human face.

[0049] As previously discussed with reference to Figures 2 and 4, it has been determined that the use of prior art needles 5 can result in the dermal filler 6 being injected into undesirable layers of the skin 1, thereby creating the risk of unnecessary subcutaneous bleeding, vascular occlusion, and uneven cosmetic results.

[0050] 3A and 3B illustrate how a curved needle 5 according to an embodiment of the present invention can be used to reduce the risks associated with prior art needles. As shown in FIG. 3A, it has been determined that the use of a curved needle 5 (i.e., a needle that includes a curved region) allows the angle at which the needle passes through and along the skin layer to be varied, increasing the likelihood that the needle 5 will remain in the desired layer of the skin 1, such as within the dermis 3. That is, with prior art needles, the needle tip 7 generally continues to follow the angle of entry into the epidermis 2, making it difficult to pass the needle 5 along a layer of the skin 1 without penetrating another layer of the skin. The use of a curved needle 5 allows the angle of the needle tip 7 and the distal end of the needle 5 to be more generally varied, each of which can pass along a particular layer of the skin 1. As further shown in FIG. 3B, it is believed that such a configuration increases the likelihood that the dermal filler 6 will be injected and remain in the desired layer of the skin 1, thus achieving the desired cosmetic effect.

[0051] 3A and 3B show a retrograde method of depositing dermal filler 6, in which needle 5 is first inserted into the desired location (see FIG. 3A), and dermal filler 6 is injected as needle 5 is (at least) partially withdrawn from skin 1 (see FIG. 3B). In an alternative embodiment of the present invention, dermal filler 6 can be deposited using an antegrade method, in which dermal filler 6 is injected as needle 5 is inserted into skin 1. Retrograde and antegrade methods are considered "linear threading" or "tunneling" deposition methods, respectively. Antegrade methods may be commonly performed on tear troughs or vermilion lips, as the medical professional can better visualize the tracking of the dermal filler. Retrograde methods may be commonly used to fill deeper wrinkles (such as around the nasolabial folds and marionette lines) or to plump up the lips. While curved needles 5 according to embodiments of the present invention may be particularly suited to linear threading methods as described above, such needles 5 may also be used in "multiple injection" methods, such as the depot method, or more generally, methods in which a bolus deposit of dermal filler 6 is injected while the needle 5 is stationary.

[0052] 6A and 6B further illustrate the utility of a curved needle 5 in injecting dermal filler 6 into the lips. As shown in FIG. 6A, the use of a curved needle 5 according to an embodiment of the present invention would allow the tip 7 of the needle 5 to follow the contours of the lip and follow the desired skin layer, such as the dermis 3. As shown in FIG. 6B, this would further allow the dermal filler 6 to be injected into the desired layer of the skin of the lips to provide a desired deposition of the dermal filler 6, thereby reducing the risk of subcutaneous bleeding, vascular occlusion, and poor cosmetic results.

[0053] In addition to the safety benefits mentioned above, it has surprisingly been found that the use of curved needles according to embodiments of the present invention can provide improved cosmetic results by facilitating the deposition of dermal filler in curved lines that conform to human facial features. As noted with respect to the prior art, the use of straight needles facilitates linear deposition of the filler, resulting in linear filling of facial features. This is in contrast to the desire for dermal fillers, which are intended to provide fuller, rounder features, such as round lips.

[0054] FIG. 14 shows various facial features where dermal filler has been deposited in a curvilinear manner.

[0055] As shown in FIG. 14A, the use of a curved needle according to an embodiment of the present invention facilitates a round bolus of dermal filler when filling the two lower nodules 23. That is, to provide a round bolus using a curved needle according to the present invention, the practitioner can perform a single insertion and provide a first outer curved deposit following the natural path of the curved needle 5. Without completely withdrawing the needle 5, the practitioner can simply follow the natural trajectory of the curved needle 5 to retract to a previous position and provide further curved deposits. FIG. 14A shows a round bolus generated from four curved deposit lines. The needle can be removed after the completion of four (in the illustrated example) deposit lines.

[0056] 14B, the use of a curved needle 5 facilitates the practitioner to follow Cupid's bow when making the deposition of dermal filler 25. That is, the curved line of Cupid's bow 24 can be followed simply by having the path of the deposition 25 follow the natural course of the curved needle 5.

[0057] As shown in FIG. 14C, the use of curved needles 5 also facilitates the practitioner to provide a rounded, fuller deposition of dermal filler 25. As previously described with respect to FIG. 13D, practitioners often perform vertical injections into the lower lip to "fill in" the lower lip to increase the height and contours of the lower lip. Using existing injection needles, the dermal filler is often deposited in a straight line, which instead of providing a fuller, rounder effect, results in the opposite of the desired result of the deposition flattening the lower lip. In contrast to the prior art, the use of curved needles according to the present invention facilitates a rounded deposition of filler 25 into the lower lip, allowing for a fuller, rounder lower lip structure.

[0058] 7, a way of describing the characteristics of the curvature of the curved region 19 of the needle 5 will now be described. The curvature of the needle 5 can be considered to approximate a segment of a circumference, and thus the curvature includes: Arc length 17 represents the distance along the arc between two end points, e.g., the distance along the curve between points A and B, or the distance along the curve between points C and D. This represents the chord length 15, i.e. the distance along the line segment where the endpoint intersects with the endpoint along the arc. represents an apex angle 16, i.e., the apex angle of an isosceles triangle that is tangent to an arc at an end point (whose entire chord length represents the hypotenuse of the triangle) and at a point equidistant from the end point (where the apex angle is tangent to the arc at this equidistant point). Throughout this specification and the claims which follow, the term "apex angle" shall be construed in accordance with this definition.

[0059] When describing the curvature of a needle by reference to terms such as "arc length," "chord length," and "apex angle," it is not intended that the curvature of the curved region be necessarily circular. Rather, the curved region may adopt an approximately curved shape, such as circular, elliptical, parabolic, hyperbolic, and combinations of any one or more of the above, for example. In this context, to the extent possible, the terms "arc length," "chord length," and "apex angle" are to be interpreted in the context of the curved region as describing the length of the curved region that more generally follows a curve, without requiring the curved region to be circular or any other particular curved shape.

[0060] Another way of determining the characteristic or extent of the bend region is by defining a bend degree, which simply relates to the extent of change in needle direction from the start of the bend region to the end of the bend region, measured in degrees as follows: The bending degree in a straight area without curvature is 0°; The bend degree of a curved region where the direction of the end of the curved region is perpendicular to the direction of the start of the curved region is 90°; and A curved region where the direction in which the curved region ends is parallel to but opposite the direction in which the curved region begins has a bend degree of 180°.

[0061] According to one particular embodiment of the invention, the curved region 19 of the needle 5 comprises: Arc length 17 between 8mm and 18mm, optionally between 11mm and 16mm, further optionally between 12mm and 14mm; Apex angle 16 between 160°~179°, optionally between 165°~175°; 15, with a string length between 9 and 11 mm, and / or A bending degree between 5° and 50°, optionally between 10° and 45°, further optionally between 15° and 40°, and still further optionally between 20° and 35°. Such an arrangement is further discussed with reference to FIG.

[0062] 8A, 8B, and 8C each show a needle according to an embodiment of the present invention, each including a curved region 19 and a first straight region 18, and thus In FIG. 8A, needle 5 includes: a first linear region 18 having a length of 6.5 mm; and a curved region 19 with a chord length 15 of 6.5 mm and an apex angle 16 of 165° (and a bend degree of approximately 35°); In FIG. 8B, needle 5 includes: a first linear region 18 having a length of 4 mm; and a curved region 19 with a chord length 15 of 9 mm and an apex angle 16 of 165° and a bend degree of approximately 35° (in other words, the needle 5 of FIG. 8A includes a longer first straight region 18 and a shorter curved region 19 than that of FIG. 8A, despite having approximately the same bend degree); and In FIG. 8C, needle 5 is shown having a needle tip 7 with an outward bevel. That is, according to certain embodiments of the present invention, tip 7 of needle 5 is "beveled" or "angled" to provide a sharper edge for insertion into the layers of skin 1. The beveled tip 7 shown in FIG. 8C points away from the curvature of curved region 18, meaning that tip 7 has an outward bevel. In alternative embodiments (e.g., as shown in FIG. 9), tip 7 has an inward bevel, whereby the bevel points in the direction of the curvature of curved region 19. In some embodiments, needle 5 can include multiple bevels, such as by incorporating a double bevel design, which can provide a less painful injection (without wishing to be bound by theory).

[0063] FIG. 9 shows a needle 5 according to an embodiment of the present invention, which includes a first straight region 18, a curved region 19, and a tip 7 that includes an outward bevel. The straight region 18 is approximately 10 mm long, while the curved region 19 has a chord length 15 of approximately 9 mm, an apex angle 16 of approximately 165°, and a bend degree of approximately 15°. FIG. 9 also shows the outer and inner diameters of the needle 5, whereby the outer diameter 22 is approximately 0.309 mm and the inner diameter 21 is approximately 0.165 mm (providing a wall thickness of approximately 0.072 mm). This approximates a thin-walled "30 gauge" needle thickness profile. When referring to wall thickness and needle diameter, it is noted that the process of providing the curved region 19 may slightly change the wall thickness and diameter of the needle in and near the curved region 19. For example, the process of providing curved region 19 may reduce the diameter of needle 5 within curved region 19 or generally "flatten" the cross-sectional shape of needle 5 to provide a more elliptical cross-section. Thus, references to diameter, wall thickness, and gauge are intended to allow for reasonable variations, particularly within and near curved region 19, as a result of the manufacturing process.

[0064] FIG. 10 illustrates a needle 5 according to an embodiment of the present invention, which includes a first straight region 18, a curved region 19, a second straight region 20, and a tip 7 including an inward bevel. The length of the first straight region 18 is approximately 6 mm, the length of the second straight region 20 is approximately 6 mm, the chord length 15 of the curved region 19 is approximately 4 mm, the apex angle 16 of the curved region 19 is approximately 150°, and the degree of bend is approximately 30°. Similar to FIG. 9, FIG. 10 also illustrates the outer diameter 22 and inner diameter 21 of the needle 5, whereby the outer diameter 22 is approximately 0.309 mm and the inner diameter 21 is approximately 0.165 mm (providing a wall thickness of approximately 0.072 mm). This approximates a thin-walled "30 gauge" needle thickness profile. In alternative embodiments, the needle 5 may include a standard thickness between 25 gauge and 32 gauge, or a thin-wall thickness profile between 25 gauge and 32 gauge. FIG. 11 contrasts the thin wall thickness profile to the standard thickness profile of needle 5.

[0065] As shown in Figures 9 and 10 described above, in certain embodiments of the present invention, the curved region 19 of a needle 5 that includes a second straight region 20 may have a shorter chord length 15 than would be found in a needle 5 that does not include a second straight region 20.

[0066] To ensure that the needle 5 can be used for injection into the human body, the needle 5 according to embodiments of the present invention may be constructed from a non-toxic, non-corrosive, durable material, such as stainless steel, titanium, cobalt, chromium, or platinum. In one embodiment, the needle 5 is constructed from stainless steel. In a further embodiment, the needle 5 is constructed from stainless steel 440, which allows for the production of a very sharp tip 7.

[0067] Needles 5 according to embodiments of the present invention may be manufactured according to any suitable process as understood by one of ordinary skill in the art. A common process for manufacturing straight needles involves tube drawing, in which a tube is drawn through progressively smaller dies to produce straight needles, with the end of the needle being beveled to form a sharply pointed tip. According to certain embodiments, straight needles may be bent to provide curved region 19 using tools similar to compression bending tools used for larger pipes and tubes in connection with trades such as plumbing. According to certain embodiments, straight needles may be heated prior to bending to address issues such as metal fatigue that may affect the strength or other physical properties of bent needles 5. In alternative embodiments, other methods of providing bent needles 5 may be utilized, for example, applying principles of rotary draw bending, mandrel bending, compression bending, or roll bending. According to certain embodiments, methods of providing curved region 19 are utilized that maintain the strength of needle 5 and prevent or minimize reduction in the diameter and wall thickness of needle 5 in and around curved region 19.

[0068] In one embodiment, the proposed needle 5 is packaged in a blister pack due to its sharp tip, allowing for safe and convenient storage of the needle 5. In an alternative embodiment, the needle may be packaged with a curved or flexible cap or sheath adapted to match the shape of the needle 5. In an alternative embodiment, the needle 5 may be packaged in a self-contained box-type container with a screw-off hub cover to which a syringe can be attached.

[0069] Embodiments of the present invention also relate to methods of injecting dermal filler 6 using a needle 5 including a curved region 19 as described above. In certain embodiments, the present invention relates to methods of injecting dermal filler 6 into the dermal layer 3 of the lips or the perioral region of the face. According to certain of these embodiments, the needle 5 is inserted into or adjacent to the vermilion 9, aiming at the body (wet / dry) boundary of the lips. Moreover, according to certain of these embodiments, the dermal filler 6 is injected as the needle 5 is partially withdrawn from the skin 1. In one embodiment, the dermal filler 6 is injected as the needle 5 is further inserted into the skin 1 and / or a bolus deposit of dermal filler 6 is injected while the needle 5 is stationary.

[0070] FIG. 12 shows a prototype of the proposed needles 5, which are equipped with a luer lock located at the proximal end of each needle 5.

[0071] Many modifications of the structure and widely different embodiments and applications of the present invention will become apparent to those skilled in the art to which the present invention pertains, without departing from the scope of the present invention as defined in the appended claims. Furthermore, the needles 5 as disclosed and described may be suitable for other applications that are not limited to the injection of dermal fillers 6. Thus, unless the context requires otherwise, the use of the disclosed needles 5 need not be limited to the injection of dermal fillers 6, but other applications are possible. The disclosures and descriptions herein are purely illustrative and are not intended to be limiting in any way.

Claims

[Claim 1] A needle for injecting a dermal filler into the dermis, comprising: a proximal end for coupling to a syringe; a distal end including a sharp tip; Equipped with The needle includes a curved region between the proximal end and the distal end.

Images