Patent Application
20200146712
The invention relates to medical devices; and more particularly, to a device for planning and guiding medical and cosmetic injections, such as, for example but not limitation, administration of botulinum toxin for medical and cosmetic applications.
The procedure for injecting botulinum toxin is both an art and science that only a qualified healthcare professional should perform.
There are forty-three muscles in one's face, and it's vital that the person who performs botulinum toxin injections understands and pinpoints the correct spots to optimize the treatment. Muscles which are commonly identified for receiving botulinum toxin injections include: procerus, corrugator, frontalis, and orbicularis oculi muscles.
For most procedures, a very thin needle is used to inject small amounts of botulinum toxin into specific muscles. By carefully choosing specific muscles, only the wrinkle-producing muscles are affected, preserving the patient's natural facial expressions.
Currently, physicians are approximating injection sites, for example, by asking a patient to contract the relevant muscles, and using a marking implement to apply markings on the face of a patient where a physician estimates the injection to be beneficial. However, using such conventional techniques often produces asymmetrical results, and other side effects which are generally problematic. There is no standardized protocol for determining injection sites for botulinum toxin injections.
There is a need for improved devices and related protocols that will improve consistency and repeatability, as well as symmetry of injection sites for use with the administration of botulinum toxin.
The disclosure is directed a device and related methods for guiding medical injections, and more particularly, for marking injection sites for subsequent injections. The device generally includes a disc portion and a handle portion extending therefrom. The dimensions of the aperture and periphery are selected to be useful for medical and cosmetic injections, such as administration of botulinum toxin. The device is used to identify and mark injection sites thereby planning the procedure and guiding the physician during administration of the injections.
In an illustrated embodiment, the device comprises: a disc portion and a handle portion; the disc portion extends radially from an aperture to a periphery, wherein the aperture is disposed at a center of the disc portion; the handle portion is coupled to and extends outwardly from the periphery of the disc portion; wherein the handle portion is bent relative to the disc portion at a bending line.
Other embodiments are further described herein.
The features and benefits of the invention will be further appreciated by one with skill in the art upon a thorough review of the illustrated and other embodiments as set forth in the appended detailed descriptions and drawings, wherein:
For purposes of explanation and not limitation, details and descriptions of certain preferred embodiments are hereinafter provided such that one having ordinary skill in the art may be enabled to make and use the invention. These details and descriptions are representative only of certain preferred embodiments, however, a myriad of other embodiments which will not be expressly described will be readily understood by one having skill in the art upon a thorough review hereof. Accordingly, any reviewer of the instant disclosure should interpret the scope of the invention by the claims, and such scope is not intended to be limited by the embodiments described and illustrated herein.
In a general embodiment, a device for guiding and planning medical and cosmetic injections is disclosed. The device is particularly useful for administration of botulinum toxin about the face of a patient, particularly the forehead area, for cosmetic applications, such as treating wrinkles, but also for medical applications such as, inter alfa, to treat excessive sweating or migraine headaches.
The device for guiding medical and cosmetic injections generally comprises: a disc portion and a handle portion; the disc portion extends radially from an aperture to a periphery, wherein the aperture is disposed at a center of the disc portion; the handle portion is coupled to and extends outwardly from the periphery of the disc portion; wherein the handle portion is bent relative to the disc portion at a bending line.
In an embodiment, the disc portion comprises a disc-diameter, wherein the disc-diameter is between 10.0 mm and 60.0 mm. In a preferred embodiment, the disc-diameter is 30.0 mm.
In another embodiment, the aperture comprises an aperture-diameter, wherein the aperture-diameter is between 2.0 mm and 10.0 mm. More preferably the aperture-diameter is 6.0 mm.
In another embodiment, the handle portion is bent relative to the disc portion at an angle between 45 and 179 degrees. More preferably, the handle portion is bent relative to the disc portion at an angle that is 154 degrees therebetween.
In other embodiments, the device may comprise no bend angle. In this regard, the handle portion can be provided configured within a common plane with the disc portion.
The device may comprise a thickness between 0.5 mm and 5.0 mm. Preferably, the thickness of the device is about 2.0 mm.
The device can be molded, or may be cast or computer numerical control (“CNC”)-cut from a sheet of material, and subsequently bent using heat, pressure, or a combination thereof. In this regard, the disc portion and the handle portion may consist of a single monolithic piece.
While the device may be fabricated from metal, such as aluminum, in a preferred embodiment the device is fabricated from a plastic, such as acrylic or other polymeric compositions. In a preferred embodiment, the device is fabricated form a polycarbonate material, for example, MACROLON®.
In the preferred embodiment, the device is fabricated from a transparent material to aid in placement of the device relative to features of a patient's anatomy or skin folds, or relative to markings created by the physician.
Now turning to the drawings,
In accordance with another aspect, a method is disclosed for using the device in conjunction with a medical or cosmetic procedure. Here, the procedure comprises administration of a botulinum toxin solution, such as those known by one with skill in the art and commercially available, and the application may be cosmetic or medical, such as treating wrinkles, or treating excessive sweating at the forehead region of a patient, respectively.
As illustrated in
Step 1: washing at least the treatment portion of the patient's face (“treatment site”);
Step 2: optionally applying a topical anesthetic at the treatment site to keep the patient relaxed during the procedure;
Step 3: applying an antiseptic agent for skin antisepsis at the treatment site;
Step 4: marking a plurality of injection sites about the patient using the device as-described herein;
Step 5: preparing a botulinum toxin solution for administration;
Step 6: injecting the botulinum toxin solution at the injection sites; and
Step 7: removing the markings to complete the procedure.
During Step 1, the physician or an aid will generally apply soap and water to clean any makeup or other elements from the treatment site. Alternatively, or additionally, alcohol may be used to dissolve any foreign matter and to clean the area in preparation for treatment.
Topical anesthetics known to one having skill in the art may be optionally applied. Because the needle(s) used in botulinum toxin injections are very small, for example 30 gauge to 32 gauge, there is often no need for topical anesthetic. However, for patients experiencing a first treatment, or those weary of needles, a topical anesthetic such as, for example and not limitation, prilocaine, lidocaine, or even ice, can be applied. It is preferred that the patient is calm and relaxed during the procedure in order to avoid tension in the treatment area muscles which could introduce errors in the treatment results. As such, a topical anesthetic is preferably applied to numb the treatment area.
An antiseptic agent, such as isopropyl alcohol, is generally applied to reduce the incidence of surgical site infections (S SI) at the treatment site.
With Steps 1 thru 3 complete, the next task is to prepare the patient with markings for guiding injections during the procedure. In this regard, the device as described herein is utilized to plan and mark the required injection sites about the patient's frontalis muscle (forehead region).
The physician begins by asking the patient to maximally elevate the eyebrows. With the patient's eyebrows maximally elevated, the physician then marks the inferior border and superior border of the frontalis muscle by marking the lowest and highest frontal wrinkles, respectively, using a marking element, thereby creating an inferior frontalis marking (31,
Next, with reference to
The device is then moved horizontally (left and right) to place the periphery of the device at a second and subsequent positions 34; 35; 36; 37 as shown, each of which is located along the inferior frontalis marking 31, and adjacent to the peripheral trace of the previous marking or the first trace; whereby at each position along the inferior frontalis marking a subsequent marking is made at the aperture and the periphery of the device.
Markings (tracings of the device periphery and aperture) are applied along the left-and right-sides of the first trace 33 until the frontalis muscle is completely marked with a plurality of device-markings extending along a “lower disc-lane 41” as shown in
Again referencing
Now, with markings created, the physician may prepare a botulinum toxin solution. Alternatively, the composition is prepared prior to the patient's visit. Preparing the botulinum toxin solution may require dilution and loading a syringe with the composition. As mentioned above, a 30-gauge or 32-gauge needle is preferred (though 27-34 gauge can be used).
The needle is placed at each of the injection sites identified by the aperture-dot markings previously applied. The physician will inject a botulinum toxin solution at each injection site.
While various details, features, and combinations are described in the illustrated embodiments, one having skill in the art will appreciate a myriad of possible alternative combinations and arrangements of the features disclosed herein. As such, the descriptions are intended to be enabling only, and non-limiting. Instead, the spirit and scope of the invention is set forth in the appended claims.
